The Toxic Substances Control Act (TSCA) was passed in 1971 as one of the nation’s early chemical control regulations. Prior to 1970, federal regulations of harmful chemicals were very limited. These regulations tended to be specific to one exposure medium (e.g., air, water), and they intervened only after contamination had occurred. TSCA was passed in response to a need for a comprehensive regulatory framework for industrial chemicals. When TSCA was passed, there were upwards of 60,000 industrial chemicals in commerce in the United States. Currently, there are over 84,000 industrial chemicals on the TSCA inventory.
Under TSCA, the US Environmental Protection Agency (EPA) is authorized to screen chemicals, require reporting or testing on chemicals, ban manufacturing or importing of chemicals, and track new chemicals. However, in the 35 years since TSCA was passed, EPA has required testing on less than 300 substances. EPA has only attempted to ban nine chemicals, and was unsuccessful in its attempt to ban one of them (asbestos). For this and numerous other reasons, TSCA has undergone significant criticism in recent years, making clear the need for TSCA reform.
Among the primary criticisms of TSCA are the complex and burdensome requirements that EPA must meet to require testing of chemicals. There is also little transparency regarding how EPA determines and prioritizes chemicals of concern, assesses the safety of these chemicals, and decides when risk assessment and/or management is needed. In addition, confidential business information (CBI) claims limit the public’s access to substantial amounts of risk-related information.
In response to criticisms of TSCA, EPA published principles of TSCA reform in 2009. The principles emphasized the need for sound science, risk-based criteria for reviewing chemicals, manufacturers to supply safety information, consideration of sensitive subpopulations in assessments, consideration of cost and substitutes in assessments, prioritization, incorporation of green chemistry, and sustained funding for EPA to conduct assessments. Also in 2009, EPA released an Enhanced Chemical Management Program. EPA then expanded on this effort in the Existing Chemicals Program, which was published in 2012. The 2012 Program described a two-step prioritization process for identifying chemicals for expedited review. From 1000 candidates, 83 chemicals were selected. As of May 2013, 30 have been listed for assessment and five draft assessments have been published.
In April 2013, the US Government Accountability Office (GAO) published a report in which they evaluated EPA’s efforts to strengthen chemicals management. Their findings were mixed. On a positive note, EPA has increased efforts to obtain toxicological and exposure data. However, it may take years to obtain the data using the vehicles in place, and it is not clear that this review process will result ultimately in risk reduction. GAO also found that EPA has missed some opportunities to obtain data submitted by companies to foreign governments. For example, EPA could take further action to report toxicity and exposure data submitted to the European Chemicals Agency under the REACH regulation.
Also in April 2013, the Safe Chemicals Act was reintroduced in identical form to an act with the same name that was introduced (but not passed) in 2011. Among other things, the Safe Chemicals Act would shift the burden of safety to chemical companies and give EPA full authority to require data beyond a minimum data set. The Act has been co-sponsored by Democrats and Republicans in the Senate.
CPS risk assessor, Elizabeth Dederick, PhD, will present on TSCA and TSCA reform at a workshop in Germany hosted by Knoell. Details on the workshop are available here: http://www.knoell.com/en/event/workshop-asia-north-america-2013.