On April 29, 2013, the U.S. Government Accountability Office (GAO) released a report entitled Toxic Substances: EPA Has Increased Efforts to Assess and Control Chemicals but Could Strengthen Its Approach, which provides the results of a performance audit conducted by GAO from December 2011 to March 2013. GAO reviewed the extent to which: (1) the U.S. Environmental Protection Agency (EPA) has made progress implementing its new approach for managing toxic chemicals with the goal of ensuring the safety of chemicals using its existing authorities; and (2) the new approach positions EPA to achieve its goal of ensuring the safety of chemicals. GAO concluded that, although EPA has implemented a new approach to managing existing chemicals, it should take further action, such as promulgating rules under Section 8 of the Toxic Substances Control Act (TSCA) to require chemical companies to report chemical toxicity and exposure-related data submitted to foreign agencies and to require chemical companies to report exposure-related data from processors to EPA. The report is available online.
Background
GAO has repeatedly faulted EPA’s chemicals management program. GAO states that in 2005, it reported that EPA failed to use its TSCA authority to obtain information submitted by U.S. companies to foreign governments. According to GAO, this information could include important data on chemical toxicity, and GAO recommended that EPA promulgate a rule requiring that companies provide it with copies of any health and safety studies, as well as other information concerning the environmental and health effects of chemicals, submitted to foreign governments. GAO also recommended that EPA improve and validate its models for assessing and predicting the risks of chemicals, and revise its regulations to require companies to reassert confidentiality claims within a certain period. While EPA implemented GAO’s recommendation to improve its model, and did not disagree with its recommendations regarding obtaining health and safety studies submitted to foreign governments and requiring companies to reassert confidentiality claims, it has not fully implemented these recommendations. GAO states for this and other reasons, in 2009, it added EPA’s processes for assessing and controlling toxic chemicals to its list of programs at high risk of waste, fraud, abuse, and mismanagement. GAO released its 2013 update on February 13, 2013, and EPA’s processes for assessing and controlling toxic chemicals remain on the list of programs at high risk. The 2013 update is available online.
Findings
In 2009, then EPA Administrator Lisa Jackson announced TSCA reform principles intended to inform ongoing efforts in Congress to strengthen TSCA. At that time, EPA also initiated a new approach for managing toxic chemicals with the goal of ensuring the safety of chemicals using its existing authorities. GAO found that, since 2009, EPA has made progress implementing its new approach to managing toxic chemicals under its existing TSCA authority, particularly by increasing efforts to obtain chemical toxicity and exposure data and initiating chemical risk assessments. According to GAO, in most cases, the results of EPA’s data collection activities have yet to be realized, and it could take several years before EPA obtains much of the data it seeks. GAO concluded that EPA has not pursued some opportunities to obtain chemical data that companies submit to foreign governments or to obtain data from chemical processors that prepare chemical substances after their manufacture for distribution in commerce, and GAO believes these data could help support EPA’s risk assessment activities.
Of the 83 TSCA Work Plan chemicals that EPA prioritized for risk assessment, EPA initiated seven assessments in 2012. GAO states that EPA plans to start 18 additional assessments in 2013 and 2014. GAO notes that it could take several years to complete the initial risk assessments and, at EPA’s current pace, over a decade to complete all 83, “especially as EPA does not have the toxicity and exposure data needed for 58 of the 83 chemicals prioritized for risk assessment.” According to GAO, EPA has initiated other actions, such as increasing review of certain new uses of chemicals, that may discourage the use of these chemicals, but GAO concluded that it is too early to tell whether these actions will reduce chemical risks.
According to GAO, EPA’s 2012 Existing Chemicals Program Strategy does not include leading federal strategic planning practices that could help guide its effort. Specifically, GAO states, “EPA has not defined strategies that address challenges — many of which are rooted in TSCA’s regulatory framework — that may impede EPA’s ability to meet its long-term goal of ensuring chemical safety.” GAO found that EPA has not clearly articulated how it will address challenges associated with obtaining the data needed for risk assessments and placing limits on or banning chemicals under existing TSCA authorities. GAO reports that EPA’s Strategy does not describe the resources needed to execute its new approach, such as identifying roles and responsibilities of key staff or offices or identifying staffing levels or costs associated with conducting the activities under its new approach. GAO states that without a plan that incorporates leading strategic planning practices, “EPA cannot be assured that its new approach to managing chemicals, as described in its Existing Chemicals Program Strategy, will provide a framework to effectively guide its effort. Consequently, EPA could be investing valuable resources, time, and effort without being certain that its efforts will bring the agency closer to achieving its goal of ensuring the safety of chemicals.”
Recommendations
GAO recommends that the EPA Administrator take the following actions:
- Consider promulgating a rule under TSCA Section 8, or take action under another section, as appropriate, to require chemical companies to report chemical toxicity and exposure-related data they have submitted to the European Chemicals Agency (ECHA);
- Consider promulgating a rule under TSCA Section 8, or take action under another section, as appropriate, to require chemical companies to report exposure-related data from processors to EPA; and
- To better position EPA to ensure chemical safety under existing TSCA authority, direct the appropriate offices to develop strategies for addressing challenges that impede the Agency’s ability to meet its goal of ensuring chemical safety. At a minimum, the strategies should address challenges associated with:
- Obtaining toxicity and exposure data needed to conduct ongoing and future TSCA Work Plan risk assessments;
- Gaining access to toxicity and exposure data provided to ECHA;
- Working with processors and processor associations to obtain exposure-related data;
- Banning or limiting the use of chemicals under Section 6 of TSCA and planned actions for overcoming these challenges — including a description of other actions EPA plans to pursue in lieu of banning or limiting the use of chemicals; and
- Identifying the resources needed to conduct risk assessments and implement risk management decisions in order to meet its goal of ensuring chemical safety.
- Obtaining toxicity and exposure data needed to conduct ongoing and future TSCA Work Plan risk assessments;
According to GAO, it is unclear whether EPA intends to consider promulgating the recommended rulemakings. GAO states that, in its written comments, EPA stated that it intends to pursue data submitted to ECHA using voluntary or regulatory means as necessary, but did not provide information on its planned approach. With regard to obtaining data from chemical processors, EPA stated that downstream chemical processors have little exposure-relevant data, and GAO believes this suggests that EPA does not intend to implement that recommendation. GAO notes that this position, however, “conflicts with previous statements by EPA officials and EPA’s principles for TSCA reform, which state that, ‘EPA’s authority to require submission of use and exposure information should extend to downstream processors.'” The GAO report states that, in addition, EPA officials told GAO that data from downstream processors would provide EPA with a better understanding of potential exposure to chemicals, such as chemical exposure from consumer products, including those designed for children.
GAO states that it also is unclear whether EPA intends to pursue any action regarding its recommendation to develop strategies for addressing challenges associated with obtaining toxicity and exposure data needed for risk assessments, and with EPA’s ability to meet its goal of ensuring chemical safety. In its written comments, according to the report, EPA stated that it would not be able to meet the goal of ensuring chemical safety without legislative reform and, until then, EPA plans to use its Existing Chemicals Program Strategy. GAO states that it “continue[s] to believe that, without a plan that incorporates leading strategic planning practices — particularly a plan that clearly articulates how EPA will address management challenges — EPA cannot be assured that it [sic] its new approach to managing chemicals will provide a framework to effectively guide its efforts. Consequently, EPA could be investing valuable resources, time, and effort without being certain that its investments will bring the agency closer to achieving its goal of ensuring the safety of chemicals.”
Commentary
The report is well written and provides useful information, particularly the quantitative information included in the footnotes. The report is disappointingly short, however, on acknowledging the Office of Chemical Safety and Pollution Prevention’s (OCSPP) efforts in using its TSCA authority more creatively and robustly than in years past. Many in the TSCA community recognize the effort OCSPP leadership and staff have put forward in trying to make TSCA align better with the Administration’s chemical management goals. It is regrettable the GAO report does not devote more attention to what EPA is doing right under the circumstances than what it is doing wrong or not at all, and acknowledge more specifically the operational realities OCSPP must navigate.