Regulatory DevelopmentsJune 14, 2013
The U.S. House of Representatives Committee on Energy and Commerce, Subcommittee on Environment and the Economy, held a June 13, 2013, hearing on "Title I of the Toxic Substances Control Act: Understanding its History and Reviewing its Impact." The oversight hearing was intended to improve the Subcommittee's understanding of the Toxic Substances Control Act (TSCA) and its implementation. The background memorandum for the hearing notes that Title I authorizes the U.S. Environmental Protection Agency (EPA) "to gather information, require the testing of existing and new chemicals, identify potentially dangerous products or uses, and regulate the manufacture, processing, distribution in commerce, use, and disposal of chemical substance and mixtures. Title I also has sections that address protection of confidential business information and Federal pre-emption of State or local laws." More information regarding the hearing, including an archived webcast and the background memorandum, is available online.
The following witnesses testified during the hearing:
Kathleen M. Roberts, Vice President, B&C® Consortia Management, L.L.C., an affiliate of Bergeson & Campbell, P.C.;
Charles M. Auer, Principal, Charles Auer & Associates, LLC;
Alfredo Gomez, Director, Natural Resources and Environment, U.S. Government Accountability Office (GAO);
Beth Bosley, President, Boron Specialties, L.L.C.;
Daniel Rosenberg, Senior Attorney, Health and Environment Program, Natural Resources Defense Council; and
- Jeanne Rizzo, President and CEO, Breast Cancer Fund.
The witness statements and CVs are available online.
Subcommittee Chair John Shimkus (R-IL) opened the hearing, noting that bills recently introduced in the Senate have "heightened interest in Congressional action on TSCA." Shimkus suggested that any attempt to reform TSCA should begin with "fundamental oversight of how TSCA is designed and operated." He also noted the legislative activity in the Senate and, importantly, indicated in his opening statement that he was open to legislation to reform TSCA. Ranking Member Paul Tonko (D-NY) announced that the Subcommittee will be holding more hearings in the future.
To date, two bills have been introduced in the Senate. On April 10, 2013, the late Senator Frank R. Lautenberg (D-NJ) reintroduced the Safe Chemicals Act of 2013 (S. 696). More information regarding the Safe Chemicals Act is available in our April 29, 2013, memorandum. Several weeks later, on May 22, 2013, Lautenberg and Senator David Vitter (R-LA) introduced the Chemical Safety Improvement Act (S. 1009). More information regarding the Chemical Safety Improvement Act is available in our May 29, 2013, memorandum.
Roberts provided an overview of the TSCA process. Under TSCA, new chemicals must be notified to EPA and can be added to the TSCA Inventory and allowed into commerce for commercial purposes following the end of a 90-day review period. For any existing chemical, which are those listed on the TSCA Inventory, EPA has the authority to gather information under TSCA Section 8. If EPA believes that information is insufficient to make a risk assessment, EPA is authorized to require manufacturers and/or processors of chemicals to generate additional data under TSCA Section 4. After assessing the information gathered under Section 8 and/or Section 4, if EPA decides regulatory restrictions are needed to abate risks, EPA is authorized under Sections 5 and/or 6 to apply additional risk management controls. Roberts' written testimony, which is available online, includes two flowcharts concerning the TSCA process.
Auer testified that, based on a 2008 EPA report, EPA has taken action on over 15,000 (or over 30 percent of) new chemicals, a statistic he had never recognized previously. He also pointed out that over 200 existing chemicals had Significant New Use Rules, including PBTs, carcinogens, and others. Auer stated that there is a need to strengthen and improve EPA's TSCA Sections 4 and 6 authority. In addition, TSCA reform is necessary if the U.S. is to join any international treaties. While Canada and the European Union (EU) have provisions in their chemical laws concerning sharing data with foreign governments, the U.S. does not. TSCA reform could address whether and how to share confidential business information (CBI) with states and other countries. He also noted that TSCA provides "broad authority but vague priorities" and indicated that he thought this was a reason why an agenda for existing chemicals had been so difficult for EPA to develop. In his testimony, Auer discussed the experience of Canada, which also struggled to deal with existing chemicals until important legislative changes were made. Auer's written testimony is available online.
Gomez discussed challenges EPA has faced in regulating chemicals and the extent to which EPA has made progress, and challenges, if any, which persist. Over the years, EPA has announced several different processes for assessing and controlling toxic chemicals. EPA officials told GAO that EPA's new approach, initiated in 2009 and summarized in its 2012 Existing Chemicals Program Strategy, is intended to guide its efforts to assess and control chemicals in the coming years. According to GAO, the EPA strategy, which largely focuses on describing activities EPA has already begun, does not discuss how it will address challenges discussed in earlier GAO reports associated with obtaining toxicity and exposure data and banning or limiting the use of chemicals. When GAO recommended that EPA develop strategies for addressing challenges associated with obtaining toxicity and exposure data needed for risk assessments, and with EPA's ability to meet its goal of ensuring chemical safety, EPA responded that it would not be able to meet the goal of ensuring chemical safety without legislative reform.
Bosley began her testimony by noting that TSCA regulates chemical substances, and that many of these are industrial chemicals, to which consumers are not exposed. Bosley stressed the need for smart regulation that can achieve its objectives without limiting innovation. While it is often noted that there are about 84,000 chemicals on the TSCA Inventory, this is not an accurate reflection of chemicals in commerce. According to EPA's 2012 Chemical Data Reporting rule, there are fewer than 8,000 chemicals actively in commerce, defined as being manufactured at the rate of 12.5 tons/year at a single site somewhere in the U.S. Bosley suggested improving the Inventory by dividing it into an "active" and "inactive" list, which would allow EPA to focus its resources on active chemicals in commerce. Bosley acknowledged flaws in EPA's current oversight of CBI, but urged that CBI be protected from offshore manufacturers. Bosley suggested that EPA could require companies to substantiate their CBI claims at the time they are made and require resubstantiation, perhaps at five-year intervals.
Rosenberg stated that TSCA has a number of shortcomings, including: grandfathering the 62,000 chemicals that made up the initial TSCA Inventory in 1979 without a mandate for EPA to require testing and review chemicals to meet a safety standard; placing the burden of proof on EPA to prove the harm of a chemical, rather than on the chemical industry to prove its safety; failing to require a minimum data set sufficient for the evaluation of new chemicals; limiting EPA's ability to require testing other than via a rulemaking; setting a safety standard of "unreasonable risk," further burdened and weakened by the "least burdensome" test; and allowing CBI to be claimed without upfront justification (and review by EPA) and without a nominal sunset date absent re-justification.
Rizzo's testimony emphasized the flaws in TSCA, again noting that 62,000 chemical substances were grandfathered in when the TSCA Inventory was initially set in 1979, meaning chemical companies were not required to conduct safety testing. Rizzo testified that, in the 35 years since TSCA became law, EPA has been able to require testing for only a few hundred of the grandfathered chemicals, and only five chemicals overall have been restricted. According to Rizzo, it is so difficult to regulate a chemical under TSCA that EPA has not even been able to restrict asbestos, "a well-established human carcinogen."
Chairman Shimkus thanked the witnesses for their contributions.