Sound Science. Innovative Solutions.
JULY 2010
NEWS

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FROM THE PRESIDENT’S DESK: 

TSCA 2.0 – The Safe Chemicals Act

All signs are pointing to a major overhaul of the nation’s framework for chemical regulation. The three-decade-old Toxic Substances Control Act (TSCA) has longed been dismissed by environmental advocates as ineffective. Legislative proposals have been introduced in both the House and Senate and a series of stakeholder meetings and public hearings is ongoing. Meanwhile, EPA is more aggressively deploying its existing TSCA authority through a series of action plans targeting persistent and bioaccumulative chemicals.  

Preceding these domestic efforts, in December 2006 the European Union passed a new, strict chemical regulation known as REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) which requires companies selling chemical products in the EU to register those chemicals and provide a full spectrum of data on toxicity, exposure, and environmental fate and impact. The goal is to compel companies to either make safer versions of dangerous chemicals or find alternatives, and to make general improvements on chemical manufacturing, shipping, use and disposal.

These requirements, and a growing concern that American exports could be curtailed because of non-compliance, spotlight the advantages of some harmonization between EU and U.S. However, the degree to which U.S. lawmakers will be willing to match the provisions of REACH remains unclear.

Nevertheless, Senator Frank Lautenberg (D-NJ) and Representatives Bobby Rush (D-IL) and Henry Waxman (D-CA) have unveiled legislative proposals to fundamentally revamp the 34-year-old Toxic Substances Control Act of 1976. This is not the first time Congress has attempted to fix our nation’s flawed system for regulating toxic chemicals, but it is the first time that both chemical industry lobbyists and public health advocates agree that change is necessary.

Industry supports the preemptive effect a more comprehensive national law would have on state efforts to regulate the same classes of chemicals. State legislatures have become more active in chemical policy in recent years, restricting or banning several PBDE flame retardants as well as bisphenol A. Such actions can amount to a de facto national ban, given the difficulty of ensuring that a chemical in national commerce is not sold in a particular state. A uniform national framework for chemical regulation is therefore seen as preferable to a patchwork of state provisions.

Both the House and Senate versions of The Safe Chemicals Act legislation require safety testing of all industrial chemicals and place the burden on industry to prove that chemicals are safe in order stay on the market. Under current policy, the EPA can call for safety testing only after evidence surfaces demonstrating a chemical is dangerous. As a result, EPA has been able to require testing for just 200 of the more than 80,000 chemicals currently registered in the U.S. and has been able to ban only five dangerous substances.

The bills compel manufacturers to develop and submit safety-testing data on any chemicals they produce, and requiring EPA to use this data to identify and rank hazardous chemicals based on a variety of factors. Only those chemicals shown to be safe would be allowed on the market.

Beginning this month, we start a multi-part series on the proposed changes to chemical regulations in the U.S. and how these may affect companies that manufacture, distribute, and/or use chemicals. This month, we focus on the limitations of the current TCSA law and on ongoing efforts by EPA to work around these shortcomings.

Richard P. Hubner, President


About Us

The Sapphire Group is an international risk management consulting firm specializing in integrating applied science into decision-making. We provide strategic planning to protect health while advancing business goals & objectives. We do this by utilizing our core expertise in toxicology, risk analysis, exposure assessment, dose-response assessment, epidemiology, industrial hygiene, regulatory negotiation, risk communication, crisis management, litigation support, & product stewardship. In so doing, we are able to excel in providing de novo scientific evaluations & strategies; third-party review of science & its interpretation; intelligence gathering & strategy development; and assistance with science advocacy & regulatory affairs.

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The Toxic Substances Control Act (TSCA), 15 USC (C. 53) 2601-2692, was enacted in 1976 and its provisions became effective over the ensuing several years. The law authorizes EPA to secure information on new and existing chemical substances. It requires manufacturers to provide written notification to EPA prior to manufacturing or importing new chemicals, or marketing an existing chemical for a significant new use. New chemical notifications are reviewed by the agency and if the agency finds an "unreasonable risk to human health or the environment", it may limit use or production volume or institute an outright ban.

In the decades since it was established, the TSCA program has been widely criticized as ineffective. Some environmental advocates deride it as the "Toxic Substances Conversation Act."

Perceived weaknesses include:

  • Acceptance of data gaps in the submissions for new chemicals. Producers are only required to provide any data they have collected, not to conduct additional testing. For cancer, tools such as structural activity relationship (SAR) analysis are sometimes used to provide a predictive understanding in the absence of analytical testing of a specific compound. For non-cancer endpoints (e.g., developmental effects), EPA has been willing to accept less rigorous testing.

  • The agency’s poor track record of banning or restricting existing chemicals under TSCA Section 6. Only 5 chemicals have been successfully addressed by the agency under that authority.

  • The ability of chemical producers to place "confidential business information" (CBI) claims on the identity of new chemicals for which health data is submitted under Section 8(e). By one account, CBI claims were made for 13,596 chemicals produced since 1976, nearly two-thirds of those considered.

     
  • The failure of the statute to keep pace with the great strides in both the science and instrumentation used to conduct chemical testing. These include the ability to assess the effects of chemical at low doses, in multiple generational studies, and/or on a molecular level. Advances in chemical testing and exposure modeling have revealed the shortcomings of traditional analysis to account for "real world" scenarios. 

Some of these weaknesses were designed into the statute. The legislative history makes clear that Congress was intent on not compromising the international competitiveness of the U.S. chemical industry. Key features of the bill, including CBI protections and the lack of a required data set for new chemicals, represent an accommodation of concerns expressed by the chemical sector.

Other features were probably not anticipated by the sponsors. The powers of the agency under Section 6 were curbed by the Fifth Circuit Court of Appeals in the Corrosion Proof Fittings case. That ruling threw out EPA’s 1989 asbestos ban on the basis that the agency had presented insufficient evidence to justify the ban, had not used the least burdensome regulatory approach, and had not adequately balanced the benefits of the restriction against the costs to industry. The inability of the agency to prevail in connection with an acknowledged carcinogen, despite a ten-year, 100,000-page administrative record did not bode well for future chemical bans. Indeed, Section 6 lay essentially dormant for the next two decades.

The agency has in recent years worked around the limits of the statute to ramp up the pace of chemical testing. This has been accomplished through voluntary compacts with chemical companies and other stakeholders under programs such as the Voluntary Children’s Chemical Evaluation Program (VCCEP), the Chemical Assessment and Management Program (ChAMP), and the High Production Volume (HPV) Challenge Program. Taken together, these initiatives resulted in testing for about 1,300 chemicals.

EPA has also announced revised policies concerning CBI claims, particularly efforts by industry to keep the identity of chemicals confidential. The agency now intends to reject such claims for any chemicals whose submissions contain data indicating a "substantial risk" to human health or the environment.

And last year, Administrator Lisa Jackson announced a series of "chemical action plans" prioritizing substances for review under Section 6 and Section 5(b)(4). EPA contemplates a total of 12 action plans for various classes of chemicals by the end of 2010. The first round targets certain phthalates, short-chain chlorinated paraffins, polybrominated diphenyl ethers (PBDEs), and perfluorinated chemicals. The next chemicals slated for action include benzidine dyes and pigments, and bisphenol A. A number of the chemical classes under scrutiny are persistent and bioaccumulative, suggesting EPA will prioritize these concerns in a TSCA rewrite.

Jackson is emphatic, however, that the voluntary compacts and action plans are no substitute for a comprehensive rewrite of the statute. She recently told the Senate Environment Committee that "the current law . . . is outdated, and does not provide the tools to adequately protect human health and the environment as the American people expect, demand and deserve."

Next month: TSCA Modernization Promises to Amplify Testing and Data Requirements

Focus on Key People at The Sapphire Group

M. Leigh Carson, M.S., a Research Scientist and Information Specialist with The Sapphire Group, is a skilled biologist whose  responsibilities include providing technical assistance to risk assessment projects and assisting in the continual management of The Sapphire Group’s scientific information data base.  Ms. Carson has experience in elements of human health risk assessment, biological analysis, information resource management, community outreach/public communications, and environmental data analysis.

The integration of Ms. Carson’s data management and research expertise with The Sapphire Group’s proven competency in applied science enhances our turn-key solutions for our clients’ environmental, health, and regulatory challenges.