In a recent report, the U.S. Government Accountability Office (GAO) notes that EPA’s 2012 TSCA Work Plan represents a significant increase in efforts by the Agency to assess the risks posed by existing chemicals but that it may still be years before the Agency initiates actions to reduce the risks identified in the assessments.

Over the years, the GAO has been a consistent critic of the Toxic Substances Control Act (TSCA), which provides the EPA with little practical authority to regulate risks posed by existing chemicals to human health and the environment.  For example, under the infamous catch-22 in TSCA Section 4, the EPA can require companies to provide data about risks associated with their existing chemicals only after an EPA assessment generates data showing that an unreasonable risk exists. 

Historically, the EPA has been reluctant to commit the resources needed to obtain the data needed to comply with this pretzel logic.  The GAO notes that between 2001 and 2012, the EPA conducted only two TSCA-related risk assessments.

New Agency commitment

Nonetheless, in February 2012, the EPA announced that it would undertake risk assessments of 83 existing chemicals.  Assessments of 7 of those chemicals were initiated shortly afterward; also, plans were announced to subject 18 additional chemicals to risk assessments in 2013 and 2014.  In January 2013, the EPA released its first draft risk assessments under the plan, addressing 5 of the initial 7 chemicals.  The EPA told the GAO that final assessments for the 7 chemicals will be released in early 2014.  At that point, the Agency will determine which risk management actions, if any, are warranted to address the identified risks. 

10 years needed

While the GAO recognizes that these actions represent progress, the relatively rapid pace of developments since early 2012 may not be indicative of what lies ahead.  For example, before the EPA can determine whether regulatory or other risk management responses to the assessments are warranted, the Agency must consider other factors, including the costs and benefits of mitigating the risks, technological information on the feasibility of managing the risks, and the concerns of industry, environmental groups, and other stakeholders.  The GAO also observes that even if the Agency proceeds at its current pace, it will still take at least 10 years to complete risk assessments for the 83 chemicals in the TSCA Work Plan.

In addition, the initial assessments are being directed at the 25 chemicals for which the EPA has well-characterized toxicity and exposure data.  Such information is not available for the remaining 58 chemicals, and the GAO says the Agency has not articulated how or when it plans to obtain these needed data.

Further, there are unanswered questions about the type and scope of each of EPA’s planned risk assessments.  Specifically, the GAO says it is not clear about which type of risk assessments the EPA will perform on the 76 remaining chemicals.  That is, will the risk assessments focus on human health, ecological hazards, or both?  Also, how broadly or narrowly focused will the assessments be in terms of exposure scenarios? 

Answers to these questions are critical because articulation of the type and scope of a risk assessment will strongly influence the options available to the EPA. These can  include alternatives such as requiring special labeling and banning or limiting the use of a chemical.

European chemical data

In addition, the GAO is concerned that the EPA has failed to seek to obtain toxicity and exposure data that companies submit to the European Chemicals Agency and has generally not pursued exposure-related data from chemical processors.  The GAO recommends that the EPA develop strategies to obtain information through these avenues. 

Also, the GAO says the EPA should focus more on developing strategies to overcome the challenges posed by critical TSCA limitations such as the Section 4 problem noted above.  The GAO also recommends that the Agency identify the resources it needs to conduct risk assessments and implement risk management decisions.

Click here for GAO’s latest report on EPA’s actions under TSCA.