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March 10, 2010

Senate Subcommittee Holds Hearing to Obtain Business Perspectives on TSCA Reform

The ACTA Group

On March 9, 2010, the Senate Committee on Environment and Public Works Subcommittee on Superfund, Toxics, and Environmental Health held a hearing entitled “Business Perspectives on Reforming U.S. Chemical Safety Laws.” Senator Frank R. Lautenberg (D-NJ), Chair of the Subcommittee, convened the hearing with leaders of businesses that manufacture or use chemicals to examine their business perspectives on reforming the Toxic Substances Control Act (TSCA). Only two other Senators participated in the hearing: Senators David Vitter (R-LA) and Sheldon Whitehouse (D-RI).

Lautenberg opened the hearing by stating that he “intends” to introduce a bill and inviting his Republican colleagues to participate in its development. Vitter reiterated a series of principles for chemicals legislation, including “redoing” the TSCA Inventory, opposition to a Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) approach as it would “kill innovation,” and use of “repeatable studies” as the basis for actions.

This hearing was one of the more interesting ones in the recent series of TSCA-related hearings. Most notably, Lautenberg mentioned in his opening remarks that some fear his soon to be introduced bill will allow regulation or elimination of chemicals based only on an assessment of hazard data. This has been a lynchpin issue, certainly for those in the chemical industry, who insist that risk assessment must be used under any new TSCA scheme and incorporate an exposure component.

Lautenberg’s remarks seemed to be an attempt to concede this point and reassure the industry representatives soon to testify. (And their testimony did stress the need to avoid any hazard-only approach.) His remarks also stated that he is extending “an invitation to play a part” in negotiating any final legislative proposal. If his expected bill does require risk assessments as the basis for regulation, there are many other related issues that will likely prove controversial, especially regarding what the U.S. Environmental Protection Agency (EPA) is to do in the absence of reliable exposure estimates (e.g., cascading default assumptions concerning extra safety factors). As a starting point, however, given some of the rhetoric of previous hearings, this did seem to be an attempt at a major concession to the industry position.

At the same time, late in the hearing, Lautenberg asked if PBT (persistent, bioaccumulative, and toxic) chemicals should be summarily banned “without a traditional risk assessment process” since the evidence is so clear that they are causing harm. The witnesses did not point out the possible inconsistency of this later statement with the need for risk assessment mentioned in the opening statement. Both at this hearing and the recent House hearing on PBT chemicals, few have mentioned that within the agreed upon international framework there is a process which functionally assumes that exposure considerations are embedded as part of the selection criteria. Here again, assumptions about the relevance of any exposures, the reliability of any exposure measurements, and assumptions about the risk implications of any measured exposures will drive debate about any attempts at restricting those chemicals’ use on the international level.

Witnesses included:

  • Linda Fisher, Vice President, Safety Health and the Environment, DuPont;
  • Howard Williams, Vice President, Construction Specialties, Inc.;
  • Beth Bosley, Managing Director, Boron Specialties, on behalf of Society of Chemical Manufacturers & Affiliates;
  • Dr. Neil C. Hawkins Sc.D., Vice President, EH&S and Sustainability, The Dow Chemical Company;
  • Charlie Drevna, President, National Petrochemical and Refiners Association; and
  • Kathy Gerwig, Vice President, Workplace Safety and Environmental Stewardship Officer, Kaiser Foundation Health Plan, Inc.

The witness statements and an archived webcast of the hearing are available online.

Fisher described the following issues that have led DuPont to support TSCA reform:

  • Growing public awareness of exposure to chemicals, not only through environmental emissions, but also through products; and
  • Chemical regulation is rapidly changing across the globe, through programs such as the European Union’s REACH regulation, the Canadian Chemicals Management Program, and China’s recent announcement of revisions to its chemicals program.

According to Fisher, the following key elements need to be considered in reforming TSCA:

  • TSCA does not currently require EPA to assess systematically existing chemicals. Current data gathering tools under TSCA are cumbersome and time consuming, and the authorities EPA does have to identify and act on chemicals that pose concerns have proven difficult to implement.
  • Revisions to TSCA should require EPA to work its way through the prioritized chemicals, assessing the safety of exposures associated with their uses. These assessments need to be risk-based and look at chemical hazard data of sound quality and the exposure data associated with the uses of the chemicals, integrating those into a picture of the safety of those exposures.
  • TSCA reform should address what happens after the safety assessment. EPA should have a range of risk management tools at its disposal to reduce exposures to appropriate levels in a cost effective manner, including reducing plant emissions, improved manufacturing controls, and restrictions on chemical uses. In some cases, even bans of specific uses of a chemical may be warranted to protect public health — after the proper risk-based assessment.

Williams testified that industry needs a clear identification of chemicals of high and low concern to human and environmental health. Williams stated that reliability and clarity of information would greatly affect the speed to market for new products. Greater disclosure of chemicals of high concern in products is essential to ensure that specifiers and buyers are able to obtain information concerning product ingredients. Williams suggested Congress address confidential business information (CBI) issues by providing a way for industry to disclose to a credible third party the confidential information they wish to protect from competitors. According to Williams, industry should pay to develop hazard, use, and exposure data. TSCA reform should include making the data available, identifying chemicals of concern, and promoting safer alternatives through Green Chemistry.

Bosley’s testimony included a comparison of REACH with Canada’s recent categorization and prioritization of chemicals on the Domestic Substances List (DSL). According to Bosley, REACH is flawed because there was no risk prioritization prior to beginning the program. Instead, because REACH uses a volume approach, a low-risk chemical will be screened with the same priority as a high-risk chemical that is manufactured at the same, or even higher, volume threshold. Canada was able to determine that more than 80 percent of the chemicals on its DSL do not present an unreasonable risk to human health and the environment, allowing Canada to assign systematically the remaining chemicals a priority for more in-depth review. Bosley stated that two principles are essential to a sustainable chemical management law that will not eliminate jobs, economic growth, or products: (1) TSCA priorities should be established based on risk; and (2) proven regulatory mechanisms should be the basis for modernization.

Hawkins urged the Subcommittee to create an “ideal” federal chemical safety program that would:

  • Create a level playing field by screening all chemicals in commerce to determine further information needs in a tiered, risk-based fashion;
  • Ensure a scientifically objective evaluation of safety by basing its decisions on a consistent scientific evaluation of both hazard and potential exposure (an evaluation of risk), using a weight-of-evidence approach;
  • Allow EPA to take timely and effective action and ensuring a role for cost/benefit analysis in risk management decisions;
  • Include incentives for sustainable chemistry; and
  • Enhance U.S. competitiveness by ensuring, in a timely manner and with a minimum of additional resources, that chemicals are safe for their intended uses.

Drevna testified that there is a fundamental need for the federal government to manage appropriately the risks of all chemicals in commerce, from production to disposal. Drevna emphasized that chemical risk management must be appropriate for the situation and based on sound science. According to Drevna, the challenges with TSCA implementation are due more to “grossly inadequate funding, outside pressure that results in hasty regulation, and the sequence in which the TSCA tools have been implemented.” Drevna reviewed how, if EPA had used its TSCA authority differently, it could have been more effective in managing chemicals.

Gerwig described how Kaiser Permanente’s procurement and supply staff developed a unique supplier disclosure process to address the lack of chemical safety information which requires information on a product-specific basis. Kaiser Permanente also asks for information on the suppliers’ safer alternatives. Gerwig testified that challenges include determining whether “green” or “environmentally friendly” products are environmentally and biologically benign throughout the product’s life cycle. Gerwig urged Congress to provide a mechanism supporting downstream users in procuring the safest products and materials.

In questioning of the witnesses, Lautenberg stated his understanding that EPA cannot get the data it needs and cannot regulate adequately, and asked whether EPA should have this ability. Fisher noted the process hurdles in TSCA for taking these actions and agreed that a better approach is needed. Lautenberg also asked whether companies should be required to prove products are safe before use. Fisher responded that industry should have the burden to show that products are safe, while Hawkins agreed that industry should have the burden of proof but that it is a shared responsibility where industry provides the information and demonstrates safety but EPA should have responsibility for decisions. Lautenberg responded by acknowledging the need for care in revising TSCA and agreeing that sound science is important. He also asked whether PBT chemicals because of the issues presented should be restricted without the need for a risk assessment process and Fisher responded by emphasizing the need to understand exposure to manage such chemicals properly.

Whitehouse asked for written responses to several questions regarding foreign companies importing products into the U.S. and also probed Bosley’s statement in her testimony that EPA should not be “burdened with a determination that each chemical is safe for its intended use.” She responded that chemicals are not intended to be ingested or injected as is true for drugs, and many are used only in industrial applications where there is no consumer exposure.

The hearing provided a useful exchange, although it was shortened due to votes by the Senators. The lack of participation by other Senators on the Subcommittee was noted, and is in contrast to the numbers of Representatives who participated in previous House hearings on TSCA reform. There was no discussion of the concept of a multi-stakeholder dialogue or release of a discussion draft bill as opposed to formal introduction as had been proposed in a March 8 letter sent to Senate and House leaders from 18 industry trade associations.