Identifying and Reducing Environmental Health Risks of Chemicals in Our Society Workshop Summary (2014) / Chapter Skim
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3 Current Regulatory Approaches to Dealing with Industrial Chemicals
3 Current Regulatory Approaches to Dealing with Industrial Chemicals
Pages 25-50
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THE TOXIC SUBSTANCES CONTROL ACT Lynn R Goldman devoted much of her workshop presentation to a discussion of the Toxic Substances Control Act (TSCA)
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In order to take action on a new chemical about which it has some concern, the burden is on the EPA to show either that the chemical may present an unreasonable risk or that the chemical may be produced in substantial volumes and there may be substantial exposure, ClelandHamnett said. "We have to make a case for toxicity or exposure." If the agency makes that finding, it has the authority to require testing of the new chemical substance, and risk-reduction provisions can be put into place while that testing is being developed.
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For the existing chemicals side, which consists of the 62,000 chemicals that were identified back in the late 1970s, there is no mandatory review process under TSCA, she said, although the act does give the EPA authority to collect data on such things as production volume and use (GAO, 2013)
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Additionally, TSCA provided the EPA with the ability to refer certain identified chemical risks to other regulatory agencies. In the 1980s, the EPA referred some chemicals to the Occupational Safety and Hazard Administration and it referred dioxin in food packaging to the Food and Drug Administration for management by those agencies.
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Companies have various reporting requirements under TSCA. For example, if testing shows significant risk for an existing chemical or new BOX 3-1 The Asbestos Court Decision and Its Legacy In the late 1980s and early 1990s, the EPA attempted to use its regulatory authority for existing chemicals under the Toxic Substances Control Act to try to ban a number of uses of asbestos.
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"Particularly in the area of new chemicals where innovation is going on, there is a societal interest in protecting the value of that information." On the other hand, she added, because the EPA has not always made sure that companies really needed confidentiality concerning particular information, particularly years or even decades after the confidentiality had initially been granted, "there were a lot of things that were being kept confidential that perhaps really didn't merit that protection." In response to that situation, Cleland-Hamnett said, about 5 years ago the EPA started a program to identify unwarranted claims of confidentiality so more of the information that had been collected under TSCA could be put into the public domain. How the EPA Is Implementing TSCA Today Cleland-Hamnett spent the final part of her presentation describing what the EPA is doing now in its implementation of TSCA.
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The EPA will continue to conduct risk assessments on the remaining Work Plan chemicals and add additional chemicals to the Work Plan if warranted. In the area of access to data, she said, the EPA has over the past several years taken a range of significant steps to increase the public's access to information and reduce confidential business information (CBI)
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"Up until that asbestos rule," Cleland-Hamnett said, "the agency had used its existing chemical regulatory authority five times for a number of chemicals through the 1980s. After that asbestos situation we haven't used it at all, from the early 1990s until 2013." Richard Denison spent much of his presentations discussing the weaknesses of TSCA and "why so many of us believe that we need a new law." One of the biggest problems, he said, is that the original act grandfathered in tens of thousands of chemicals.
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Whereas those chemicals are designed to be biologically active, Denison said, we now know a lot of chemicals that were never designed to be biologically active actually are. The result, he said, is the situation that other speakers had already described: 62,000 chemicals grandfathered in by the original act, only about 300 chemicals required to be tested in the years since the act was passed, only 5 chemicals that have been regulated in limited ways, and 22 years since the last time the EPA tried (and failed)
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In 74 percent of the cases the manufacturers indicated that at least one of the six basic reportable data items was "not known or reasonably ascertainable." The manufacturers do not necessarily always know this use information, he said, but its absence does indicate how poor the system is performing in providing a full picture of the use of these chemicals. There is also limited availability of hazard data.
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That is what the debate around TSCA reform is all about." Industry Perspective Michael Walls, Vice President of Regulatory and Technical Affairs at the American Chemistry Council (ACC) , offered some thoughts about regulating chemicals from the perspective of the chemical industry.
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One example is the NSF International/American Chemical Society Green Chemistry Institute®/ American National Standards Institute (NSF/GCI/ANSI) Greener Chemicals and Processes Information Standard,4 ANSI-355, which was developed by a group of stakeholders to encourage business-to-business discussions about which safety or sustainability considerations are most important and to help customers encourage a dialogue with chemical manufacturers.
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"We need to have a clear discussion on how the government decides when it needs more information and then how it goes about executing those decisions." In particular, there needs to be up-front justification of claims on confidential business information, he said. "This is a key issue in TSCA reform." Looking to the future, Walls noted that the current proposed legislation in Congress aimed at reforming TSCA, the Chemical Safety Improvement Act (CSIA)
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THE EUROPEAN COMMISSION APPROACH Canice Nolan, Senior Coordinator for Global Health for the European Commission Directorate General for Health and Consumers, spoke to the workshop about the European Commission's perspective on chemicals and chemical risk. Much of his presentation was focused on REACH, which refers to the European Commission Regulation 1907/2006 on the Registration, Evaluation, Authorisation, and Restriction of Chemicals.6 Nolan began by commenting that he has generally found the interactions between the U.S.
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This was a crucial difference between the original pesticides legislation in the EU and the later legislation: In the earlier legislation the burden of proof was on the European Commission to prove that a substance was unsafe. "In 25 years we managed to do this for about 12 substances," Nolan said.
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REACH consolidated all those efforts and put them into one framework, Nolan noted. Finally, the administrative burden for new chemicals prevented innovation by imposing data requirements that did not apply to existing chemicals.
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This prevented innovation in the chemicals market." Under REACH, all chemicals are being treated equally, and the hope is that this will promote innovation and substitution in the chemical industry. REACH addresses each of the five shortcomings of the previous system that Nolan mentioned: • To address the data gaps, a databank has been set up that is run by the European Chemicals Agency.
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and also possibly concerning polymers as well. DISCUSSION Dennis Devlin of ExxonMobil Corporation, the session moderator, opened the discussion session by asking Cleland-Hamnett whether the EPA and the nongovernmental organization community are making adequate use of the 10,000 technical dossiers on the European Commission's website.
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For example, the U.S. Green Building Council is revising its lead standards for buildings to have credit options
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REACH uses a completely hazardbased approach to identify chemicals of high concern, in which chemicals are listed because of their particular hazard characteristic. "Under the CSIA," Walls said, "EPA would identify particular priorities using a risk-based process and then would do a risk assessment for those substances and make some determination about their safety under the intended conditions of use.
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"We set safety standards for automobiles at the federal level, we set safety standards for pharmaceuticals at the federal level, and there is still in both cases room for the states to act appropriately," he said. "Even under TSCA today there is a waiver provision that allows states to seek a waiver from the preemptive effective of current TSCA decisions.
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While I don't disagree that one of the big drivers that got the industry to come to the table is the need for a national program, we don't have the balance right in that bill yet." David Andrews of the Environmental Working Group noted that Canice Nolan had said in his presentation that one of the motives for instituting REACH was worries that the previous regime may have been stifling innovation because of higher data requirements for new chemicals compared to those for existing chemicals. Thus, he wondered if, because there are different standards for new and existing chemicals under TSCA, this situation might be doing something similar in the United States.
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House of Representatives Committee on Energy and Commerce, Subcommittee on Environment and the Economy held a hearing on November 13, 2013, titled "S. 1009, The Chemical Safety Improvement Act." The witness list, written testimony, and archived video are available at http://energycommerce.
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"Unfortunately," she said, "it also grandfathers in old CBI claims, which operates in the contrary direction." The California EPA Department of Toxic Substances Control put a lot of thought into the issue, she said, and it settled on three principles to guide its policies on CBI in the California Safer Consumer Product regulations. First, there should be very significant substantiation of CBI claims, including showing that the information is very guarded in other contexts and that the information cannot readily be reverse engineered through analytical chemistry or other approaches.
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"This is a commonsense way that the hazard information can be disclosed without hurting somebody's investment." The bill also gives the EPA some very sweeping preemption powers, Solomon said, far more sweeping than in existing TSCA, and these provisions are really worrisome to California and to other states in their current form. "In particular, preemption kicks in long before EPA actually promulgates any regulation," she said.
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2013. Toxic substances: EPA has increased efforts to assess and control chemicals but could strengthen its approach.
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