Managing Compliance: Enhancing Chemical Management within the Framework of Existing TSCA Regulations

Since its promulgation in 1976, the Toxic Substances Control Act (TSCA), which is administered by EPA, has focused on human health and the environment, with the overarching goals of evaluating risks and assessing human health and environmental effects before a chemical is introduced into commerce.

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In the last 2 years, momentum has been building for significant reform of the Toxic Substances Control Act (TSCA). In September 2009, EPA Administrator Lisa Jackson released a set of core principles to strengthen U.S. chemical management laws. Shortly thereafter, in April 2010, Senator Frank R. Lautenberg, D-N.J., introduced legislation to overhaul TSCA, dubbed the “Safe Chemicals Act of 2010.”

While it recently was speculated that a divided House and Senate would prevent any TSCA legislation from passing in 2011, a Feb. 3 Senate hearing to assess the effectiveness of U.S. chemical laws revealed that there still is strong support for TSCA reform.

“We are committed to being part of a bipartisan process to achieve modernization of TSCA,” said Cal Dooley, president of the American Chemistry Council, an industry group.

However, the path to reform likely will take some time. Even if a bill is passed this year, EPA still will need to go through a rulemaking process to promulgate any resulting regulations. This process could take some time, so any changes to the current chemical control law still are several months, if not years, away.

With this in mind, EPA has been working hard to enhance chemical management within the scope of the current TSCA regulations. A summary of these changes follows.

UNDERSTANDING ENHANCEMENTS

Following the 2009 announcement, EPA has been hard at work modernizing TSCA through the existing limits of the law. To date, they have released eight chemical action plans and are in the process of completing two more. The chemical action plan (CAP) indicates that the agency will be taking regulatory action through TSCA 5(a)(2), 5(b)(4) and 6(a) to increase requirements, restrict or ban numerous chemicals. Other notable enhancements include:

  • In January 2010, EPA announced that it would review confidentiality claims submitted under TSCA 8(e) to enhance the public's access to “critical health and safety information on chemicals.” Following this announcement, EPA published a statement that announced that it generally would deny confidentiality claims for the identity of chemicals in health and safety studies filed under TSCA “except in specific circumstances” and that confidential business information (CBI) was to be rejected.

    Chemicals affected by this action are those submitted to EPA with studies that show a substantial risk to human health and the environment and that previously have been disclosed on the TSCA Chemical Inventory. Under TSCA, companies may claim a range of sensitive, proprietary information as CBI. Under Section 8(e), companies that manufacture, process or distribute chemicals are required to immediately provide notice to EPA if they learn that a chemical presents a substantial risk of injury to health or the environment. Section 8(e) reports are made available on EPA's Web site. Until now, companies routinely claim CBI. The new policy will increase the amount of information available by granting public access to the chemical identification information submitted, along with other health and safety data under Section 8(e).

  • An announcement was made in May 2010 that EPA has performed a pilot program reviewing CBI claims submitted within the past 5 years. On Feb. 10, EPA notified five companies that 14 chemicals for which they had submitted confidential health and safety studies would be made public on the 31st day after the company receives the determination.

  • On Feb. 25, 2010, EPA published a proposed rule requiring testing on 29 high production volume chemicals. Following a public meeting in August 2010, a final rule was published Jan. 7 requiring manufacturers to submit data on 19 substances. This group of chemicals targets a wide variety of consumer and industrial chemical products. Data collected through TSCA Section 4 will allow EPA to obtain critical information and develop plans to mitigate risks as well as increase transparency by providing hazard characterizations to the general public.

    EPA also has made changes to IUR reporting to increase transparency and frequency. The rule currently states that reporting must occur every 5 years, but the proposed rule requires reporting every 4 years. This would provide consumers with an increased ability to determine which chemicals are being produced in their vicinity. The proposal also mandates electronic reporting, so the information will be available to the public faster and on a more consistent basis.

  • In March 2010, EPA launched its TSCA chemical inventory for free on the Web. This especially is notable as this is the first time that this inventory has been offered for free, and is part of a series of ongoing steps he agency is taking to empower the public with important information. The inventory contains a consolidated EPA list of thousands of industrial chemicals.

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