Regulatory Developments

House Subcommittee Holds Second TSCA Hearing

July 11, 2013

On July 11, 2013, the House Energy and Commerce Subcommittee on Environment and the Economy held a hearing on "Regulation of New Chemicals, Protection of Confidential Business Information, and Innovation." The Subcommittee held a June 13, 2013, oversight hearing on Title I of the Toxic Substances Control Act (TSCA). The July 11, 2013, hearing was intended to provide the Subcommittee an opportunity to examine the regulatory implementation and "real world" implications of TSCA Section 5, which concerns the manufacture and processing of new chemicals, and TSCA Section 14, which limits public disclosure of data submitted to the U.S. Environmental Protection Agency (EPA) on existing and new chemical substances and mixtures. The Subcommittee has previously stated it intends to hold additional hearings concerning TSCA. An archived webcast of the hearing is available online. A copy of our memorandum on the June 13, 2013, hearing is available online.

The Subcommittee's background memorandum for the July 11, 2013, hearing, which is available online, includes the following issues for consideration:

  1. How TSCA Section 5, premanufacture notices (PMN) and significant new use notices (SNUN), and TSCA Section 14, protection of confidential information, affect innovation;
     
  2. Strengths and weaknesses of the PMN Program, significant new use regulations, and SNUNs under Section 5;
     
  3. Adequacy of EPA's tools to make informed decisions under Section 5;
     
  4. Whether the protection provided to confidential business information (CBI) under Section 14 is appropriate; and
     
  5. How other countries treat new chemical production and information protection.

The Subcommittee heard testimony from the following witnesses, whose statements are available online:

  • Mr. Craig Morrison, Chief Executive Officer of Momentive Performance Materials Holding, LLC, and Chairman of the Executive Committee, American Chemistry Council;
     
  • Mr. Len Sauers, Vice President, Global Sustainability, Procter and Gamble;
     
  • Mr. David Isaacs, Vice President, Government Affairs, Semiconductor Industry Association;
     
  • Dr. Rainer Lohmann, Professor of Oceanography, University of Rhode Island; and
     
  • Ms. Heather White, Executive Director, Environmental Working Group.

Morrison, Sauers, and Isaacs described how TSCA allows companies to innovate while also protecting the environment and public health. According to Sauers, one of the strengths of how new chemicals are regulated under TSCA is the ability to custom tailor the safety data and information in a PMN submission to the specific new chemical in question and its potential exposures, rather than being required to provide a minimum safety data set that could include too little data or information that is not relevant. Isaacs stated that the new chemicals program employs an appropriate risk-based approach that is tailored to consider factors such as the conditions of use and exposure scenarios.

Sauers expressed concern with EPA's recent decision to require the disclosure of confidential chemical identities for which health and safety studies are provided. Sauers testified that a specific, confidential chemical identity is not needed to evaluate a health and safety study or communicate its health effects and conclusions. According to Isaacs, TSCA's current CBI provisions generally work well in providing information to the public while protecting a company's trade secrets.

Lohmann testified that TSCA reform should include limiting the time during which information will be protected as CBI. According to Lohmann, efforts to understand issues such as the effects of persistent chemicals are hampered by the lack of publicly available information. Lohmann also suggested that if a company will be marketing a chemical mixture, then it should be required to study the health effects from the mixture as it will be used. He used the example of Firemaster 550, a flame retardant, to highlight these points and TSCA's claimed failures. Firemaster 550 contains four ingredients, two of which were grandfathered in under TSCA and therefore were not subject to the new chemical requirements. White stated that TSCA's provisions concerning new chemicals allow most new chemicals to reach the market without an adequate review of their safety, and that TSCA allows companies to make unwarranted CBI claims.

The witnesses' testimony and the subsequent questions and answers focused on whether TSCA sufficiently protects the public health and environment while allowing for innovation. Sauers testified that TSCA allows companies to get chemicals into commerce within a reasonable timeframe. He repeatedly noted EPA's willingness to meet before a PMN submission is submitted to discuss concerns and ensure that EPA has what it believes are the necessary safety data for its review. Lohmann and White, however, stated that new chemicals reach the market without adequate review from EPA. Lohmann also called for a stronger Section 5, similar to the European Union's regulation on the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH). White suggested that minimum safety data sets be provided with the chemical for the review process. Morrison countered that this would "swamp" EPA and industry with unnecessary and costly testing and would "kill" innovation.

Middle ground was possibly found during Representative Gene Green's (D-TX) questioning regarding CBI. Green, representing an industry-intensive district, recognized the need to protect CBI, and proposed a provision be added that would require more validation for CBI claims. This would prevent abuse of CBI. The panel all seemed to agree with such a provision.


 
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