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March/April 2008

Chemical Regulation Challenges Industry

An Interview with Michael Kirschner, Nina McClelland and Michael Taubitz

Michael KirschnerKirschner

Nina McClellandMcClelland

Michael Taubitz Taubitz

Recent legislation, including REACH (Registration, Evaluation and Authorization of Chemicals), and RoHS (Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment) pose challenges to industry from product design to disposal. Nina McClelland, Ph.D., served as program chair for the American National Standards Institute conference, Action and Reaction, last August, which precipitated the founding of the ANSI/National Association of Manufacturers Network on Chemical Regulation. Michael Kirschner and Michael Taubitz, who are involved with the network, also played an important role in conference preparation and have emerged as leaders for industry’s response to chemical regulation.

At the August 2007 Action-Reaction Conference on Developing a Sustainable Approach to Emerging Chemical Issues, John Marburger, Ph.D., director, Office of Science and Technology Policy, Executive Office of the President, said, “We are meeting today during what I believe is still an early stage in a materials revolution that is every bit as powerful as the information revolution that has already transformed our global economy.” Would you comment on this remark?

Nina McClelland: I believe that Dr. Marburger was right on in drawing a parallel between the current potential for a “materials revolution” and the “information revolution that has already transformed our global economy.”

I have some disagreement with his characterizing its timing as “early stage.” Surely those persons in U.S. industry who are responsible for manufacturing — and supply chain — compliance understand well the here-and-now of the REACH mandate! We need to accept that we have a directive we must meet, even if we don’t fully understand the language or the intent. It is not voluntary.

We are getting feedback that some boards of directors are looking at these new requirements and saying we don’t want to do that, we are not going to. We have to transition the attitude and the mentality about this legislation. It is a mandate. It is not voluntary.

In fact, one of our strategies is to respond through an ANSI panel approach using the model that worked so effectively for the medical information initiative. We are seeing “coopetition” in action through the ANSI/NAM/ASTM relationships and communications networks, but we need more-better-faster.

I urge you to stay tuned. We must and will be both responsive to current issues and proactive for the future. We should be grateful for Dr. Marburger’s interest, insight and leadership as we transition from followers to revolutionary leaders concerned with the safety and security of all products in the new global economy.

What do you see as the priorities for U.S. industry in response to REACH and other chemical regulations? What does a company need to do now and further down the road about such legislation?

Michael Taubitz: REACH preregistration beginning this summer poses formidable challenges for U.S. industry. Industry is still awaiting guidance on key issues and lead time is once again an issue. The challenge for all industry is to get a game plan and become truly proactive. To understand these issues better, let’s step back a little.

When the U.S. auto industry first tried to deal with ELV (end-of-life vehicle regulation) reporting in 2003, our supply chain got hammered because there was no standard nor common guideline on what to report. Industry, with the help of chemical suppliers, finally developed GADSL, Global Automotive Declarable Substance List, and alleviated much of the trouble for our supply companies. The problems of lead time and non-standard approaches among industry sectors can be expected again to cause problems with REACH and any future regulation.

Manufacturing ground rules have been forever changed. European and other regulations for waste now impact design of manufactured goods. We don’t normally think of hard goods as being chemicals, but indeed they are, and because U.S. law exempted articles, we do not have the historical data and systems to analyze materials that may be used in the future.

Life cycle assessment tools that can be applied quickly and simply will be necessary to develop comprehensive data for engineers designing manufactured goods. When assessing a material for its functionality, cost, durability and so on, design engineers will need data that allows them to do trade-offs with material characteristics impacting health, safety and the environment. That data and those systems do not yet exist.

How, specifically, do you think chemical regulation will affect innovation? What actions are companies taking, or should they be taking, to be proactive in changing research and development efforts, manufacturing processes or delivery systems?

Michael Kirschner: I can speak to chemical regulation targeted at products, or “articles” in REACH-speak. Fundamentally, regulations are targeted at chemicals with toxicity (and eco-toxicity) properties that are problematic at one point or another during their life cycle. Because these properties are essentially never considered in product development, chemicals are never reviewed or weeded out based on toxicity; therefore a vast array of products contains toxic chemicals. The biggest challenge for manufacturers and their chemical supply base is to identify these chemicals before regulators do and demand replacements that maintain desired properties while reducing or eliminating toxic ones.

This is easier said than done. To date, industry has primarily approached this situation tactically and reactively: what is being restricted and what available drop-in replacement is not restricted? Note that I said not restricted, not less- or non-toxic. This approach is the least expensive and most expedient way to compliance, and due to most regulatory timeframes it’s often the only feasible approach.

For example, some brominated flame retardants were restricted by the EU (European Union) RoHS directive because they are particularly problematic through several life-cycle phases. Companies are replacing those with other BFRs that aren’t restricted. Yet toxicologists I’ve spoken to say that the entire class of BFRs has toxicity problems due, in particular, to bromine and combustion. By picking other BFRs to achieve desired flame retardance, industry is simply putting off more work until the next BFR restriction.

Innovation requires rethinking design methodologies and close cooperation between the chemical industry and its manufacturing customer base. Critical to this, of course, is that industry doesn’t know the toxicity and other environmental properties of many, many chemical substances and mixtures. In the U.S. there is virtually no oversight requiring this information on chemicals on the market: the Toxic Substances Control Act does little either to prevent toxic substances from finding their way onto the market or, once there, remove them. We need toxicity and other environmental data for all substances on the market. Imagine, for a moment, that there is no chemical-based flame retardant solution to achieving a UL 94-V0 flammability rating. What are the options? There are material options besides flammable petroleum-based plastics, and perhaps there are design-based options as well. Once the easy solution is unavailable, people, companies and industries have incentive to innovate.

Manufacturing industries need to rethink toxic substance issues and perhaps product definition and design methodologies to find innovative ways around potential toxicity and environmental performance issues. Chemical industries need to work with their customers to identify opportunities and develop incentives for them to invent new substances and solutions that have required toxicity properties plus overall improved environmental properties. However, industry needs to identify and define these requirements. This requires industry, standards organizations such as ASTM, time and money as well as an understanding with governments that industry is indeed trying to address this — and perhaps agree to put off more regulation until and unless industry fails to substantially improve environmental performance. That would be a good second step, the first being developing the industry capability to achieve it.

In the meantime, engineers need to collect and understand the toxicity of the materials they’re designing into products today — what toxicological data is and is not available? Then they can start to use that data in the trade-off and comparison part of material selection. Of course, this requires actually being able to get the data, which often doesn’t exist, and interpret it.

How is the Manufacturers Network on Chemical Regulation, sponsored by ANSI and NAM, making a difference in industry response to REACH and other chemical regulation?

Michael Taubitz: The new ANSI/NAM Manufacturer’s Network on Chemical Regulation is a cornerstone to further develop proactive approaches and risk-based tools so that compliance with future regulation is merely part of the way you are already doing business. This network is an outgrowth of a couple of years of trying to slice through the silos of industry and government. Dr. Nina McClelland was our “door-opener.” Along the way we have linked with the Automotive Industry Action Group, the ANSI Company Member Forum, NSF International, the American Chemistry Council, the U.S. Council for International Business and the National Institute for Standards and Technology before the ANSI/NAM partnership gave the effort a real toehold. We currently have five teams dealing with:

  • Global supply chain issues,
  • Policy,
  • Standards and conformity assessment,
  • Consortia, and
  • Legal and intellectual property issues.

There is much more to be done, but we have a cornerstone that finally cuts across industry and government sectors. This network links many disciplines, including policy, standards, technical experts and others.

What has been the U.S. government response to chemical regulation? How can government, both locally and federally, make a difference at the policy level? How can industry assist government in making this difference?

Nina McClelland: The government is responding, but in a typically fractured way. It is my personal hope that a proposed ANSI panel will bring together all stakeholders, including the appropriate branches, agencies and levels of government — to develop a strategy and implement action plans to deal with chemical regulation — and that industry will support and partner with the government in this effort. Make no mistake, the task at hand is enormous. But regardless of size and complexity, the well-established voluntary standards process is the most effective I know to assure the input of all stakeholders and to provide consensus solutions to issues like those we are facing with chemical regulation. The increased roles of both government and industry will be critical to a successful outcome.

How are and how will standards make a difference in compliance with chemical restriction and registration regulations? What standards, from your perspective, need to be developed now and later on?

Michael Taubitz: Standards can and will play a huge role going forward. Traditionally, regulation is the “what” with which industry must comply. Voluntary standards often follow, providing the “how.” The dilemma is the time lag and companies groping for answers. When original equipment manufacturers and industries have non-common approaches, the compliance difficulties are magnified many times over. Even though we recognized back in 2003 that a standard was needed to get the OEMs on one page and knew about ASTM International and other standards developing organizations, we had no clue how to get started. Only when we had experienced enough pain in our supply chain did we finally develop an industry standard.

With the new manufacturer’s network and the ongoing collaboration linking SDOs with others not in the standards world, I’d like to think that won’t happen again. The efforts by ASTM Committee F40 on Declarable Substances in Materials (see sidebar) and the outside links are a good case in point. We are finally putting processes in place that cut through the silos and allow collaboration and cooperation to be meaningful activities, not just words.

If F40 can develop templates and other standards-related tools for REACH preregistration and its next phases, different industry sectors will gain the opportunity to use a common tool, thus eliminating huge amounts of waste from non-common material reporting.

Standards will continue to be important from both a tactical and strategic viewpoint. I’d love to see the U.S. benchmark some Asian nations that appear to be working on regulation concurrent with the development of standards and other implementation tools. Japan and Korea have apparently been working on a globally harmonized system for classifying and labeling materials for a number of years. Assuming they move ahead with their announced 2008 implementation, they may have their “how” tools at the same time they face a legal “what.” The U.S. would be well served to do likewise.

Michael Kirschner: Standards are needed to define environmental performance properties for substances and mixtures/preparations. As I indicated before, industry currently thinks in terms of functional and other properties, which are mostly defined by standards. Similarly, we need standards and the education and training (as well as more experts!) that accompany them to be able to define, compare and trade off properties during product development. Once there are objective mechanisms that allow engineers to consider environmental performance properties of the substances for products, they will be able to use them in the process of designing products, and companies will be able to define and market products that are objectively, and provably, “greener” than the competition. This approach will allow the market to drive improved environmental performance in the same way that features, function and cost do today.

We really need tools, as Mike Taubitz says. But we can’t have tools unless we have standards for methodologies that can be automated, or that enable automated data exchange. Right now, people collect very simple data (substance type, amount and location) pretty much manually, and it is an enormous, complex and error-prone task. Much more data is required than just these pieces of information, and trying to collect, manage and maintain it in spreadsheets or in simple text-based databases is impossible. And it is still hardly usable for making decisions. For instance, an electronic product may be comprised of 1,000 or more unique substances. How do you compare the overall environmental performance of one design option over another when you have so many variables? This is a huge computational challenge as well as a fantastic opportunity for standards and software development.

Right now, we need standards for the exchange of REACH-related information up and down the supply chain. ASTM F40 is working on the first step for that and we expect that standard to be released soon. The standard will define required information and which supply chain entities require it. The next step is for an SDO to use the standard to define an XML (eXtensible Markup Language) standard that enables software to automate the information exchange.

Standards for the market, too, can be very effective. The Electronic Product Environmental Assessment Tool — the actual standard is IEEE 1680, Standard for Environmental Assessment of Personal Computer Products — is an U.S. Environmental Protection Agency-driven standard that categorizes computers and notebooks in three environmental performance levels: good, better and best (bronze, silver and gold, respectively). It has probably been used in more than $100 billion of purchases to date by governments and large companies. It is voluntary, and a good start on driving improved environmental performance. There is certainly room for improvement on what is currently considered gold level; I expect we’ll need platinum and titanium levels in the future. We’re now expanding the standard to cover other electronic equipment.

What long-term effects do you think RoHS, REACH and other directives will have on the EU and its trading partners?

Michael Taubitz: While compliance is difficult, industry has and will continue to deal with chemical/waste regulation like ELV, RoHS, WEEE (waste electrical and electronic equipment) and REACH. The EU is a huge market and most industry sectors will choose to continue to sell products there. While some might try to make a case regarding non-tariff barriers to trade, the real long-term challenge is for global manufacturing to develop the tools and systems mentioned. I think we have to accept that the rules have changed.

A couple of years ago, when we were sitting around a table groaning about REACH (something the group had agreed not to do), my buddy Nina (McClelland) got everyone’s attention when she said, “We’re not here to talk about REACH, we’re here to work on WHN.” After a couple of moments of silence, she clarified that WHN is “What the hell is next?” We don’t know what or when but it’s coming. The challenge to proactively get at WHN still lies before us.


Michael Kirschner has been president and managing partner of Design Chain Associates, LLC, since its inception in 2001, and he is an internationally recognized expert in the analysis and impact of environmental regulation on electronic products, as well as a sought-after speaker and author. Kirschner is a member of ASTM Committee F40, among other industry groups.

Nina McClelland is president of Nina I. McClelland, LLC, a consulting practice she established after retiring as chairman, president and chief executive officer of NSF
International. She is also an adjunct professor in the Department of Chemistry at the University of Toledo and a principal in the International Clean Water Program.

Michael Taubitz is a mechanical engineer whose career began in manufacturing during the 1960s. He worked in engineering and human resources, with the most time spent in occupational safety. In 1999, he established General Motors’ new activity to provide technical liaison for emerging global health and safety issues. His most recent efforts deal with chemical issues and regulation.