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Live at GlobalChem: What is the “sweet spot” in chemical regulation?

5 min read


I’m in Baltimore, Md., this week for GlobalChem, the global chemical-regulation conference co-hosted by the American Chemistry Council.

Finding “common ground” on a regulatory environment that protects consumers and industry trade secrets as well as leads to a science-based system for producing chemicals was the unofficial theme Tuesday at the GlobalChem Conference and Exhibition.

That common ground between the Environmental Protection Agency, the industry and other stakeholders often was easiest to establish on broad goals and harder to find on specifics, while differences emerged on the specifics of reforming Integrated Risk Information System assessments and the Toxic Substances Control Act, the positives of each program and even their relevance.

EPA’s search for common ground

The EPA had a strong presence in morning sessions, with presentations from Jim Jones, acting head of the Office of Chemical Safety and Pollution Prevention, and Wendy Cleland-Hamnet, director of the Office of Pollution Prevention. Both emphasized a respect for the chemical industry and what it does, as well as the belief that there can be found what Jones called the “sweet spot” in EPA and stakeholders making chemicals safer under a regulatory environment that’s clear, concise and comprehensive. Cleland-Hamnet emphasized this, saying she “can’t think of a more important audience than this one,” acknowledging the proper role of entities outside government to achieve safety in chemicals.

One focus for both EPA officials was the agency’s effort on existing chemicals, with three priorities being risk assessment and reduction; data collection and screening; and enabling public access to data. Last week, the agency released a list of 83 chemicals to undergo risk assessment, with seven planned for 2012. The agency will use existing data to evaluate a need for further assessment, and it is hoping to access data collected under REACH, Europe’s chemical-regulation system, among other sources. Notably, this action, a “work plan,” is separate from ongoing “action plans.”

The state of IRIS and TSCA

Most discussions about the EPA’s Integrated Risk Information System or the 1976 Toxic Substances Control Act assume that there is a need for reform of flawed systems. That was a sentiment expressed in some form by nearly all parties, but some panelists also illustrated positives of or potential for both programs.

For instance, Christopher Bell of Sidney Austin argued that TSCA has been able to confront issues and adapt to new realities surprisingly well during its 36-year history, including in ways that more modern systems have not adopted. He cited TSCA’s use of computer monitoring and risk-based reviews, as well as its ability to deal with certain nanomaterial issues and phase out certain chemicals.

On IRIS, Rena Steinzor of the Center for Progressive Reform suggested that the problem more illustrates a lack of resources and a resultant lack of speed in assessments. She urged the industry to be wary of vilifying the EPA lest it weaken the agency so it cannot serve functions that help consumers and the industry. Meanwhile, David Fischer of the American Chemistry Council said it’s important to get assessments right, for while they are nonbinding, they greatly influence policy decisions and “take on a life of their own.” An incorrect analysis has harmful economic effects and allocates vital resources incorrectly, Fischer said. Another issue he noted is that more than 80% of existing assessments are at least 15 years old.

The National Academy of Sciences issued recommendations for IRIS changes, including allowing the group to evaluate select assessments. Acting IRIS Director Vincent Cogliano said the EPA agrees with and is implementing the recommendations. However, while many reform advocates might look to reshape IRIS and add extra reviews, Cogliano said he seeks a day when the EPA doesn’t need outside science to verify IRIS findings. Steiznor expressed a desire to end inter-agency review and limit outside science reviews as part of a general streamlining of the process.

Recent changes in CBI

Underlying many of these issues are industry concerns about confidential business information, or CBI, and what Christina Franz of ACC, Mark Duvall of Beveridge & Diamond and others noted as a shifting position that is less favorable toward CBI claims future, present or past. Duvall, especially, delved into the regulatory history regarding CBI issues, arguing that many long-existing statutes protect the trade-secret status of chemical identity, distinguishing that from effect data from health and safety studies that must be disclosed.

The worries, of course, of a limited CBI environment include a loss of competitive advantage and a disinclination to innovate.

Hazard and exposure

The EPA, ACC and the American Petroleum Institute discussed tools for assessing which of tens of thousands of chemicals most urgently require further assessment and possible action. One area of common ground is a need to highlight high risk of hazard and exposure, rather than elevating a chemical to “high” risk based on one criterion. In general, parties acknowledged a preference for the EPA to be the deciding agency on such matters, rather than states.

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