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February 23, 2010

OIG Report Concludes EPA Needs Coordinated Plan to Oversee Its TSCA Responsibilities

The ACTA Group

On February 18, 2010, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released a report entitled EPA Needs a Coordinated Plan to Oversee Its Toxic Substances Control Act Responsibilities, urging EPA to coordinate better risk assessment and oversight activities by establishing a management plan that contains new goals and measures that demonstrate the results of Office of Pollution Prevention and Toxics (OPPT) and Office of Enforcement and Compliance Assurance (OECA) actions. OIG conducted the evaluation to review EPA’s implementation of the Toxic Substances Control Act (TSCA) by determining how well EPA’s processes for oversight and regulation meet the objectives of TSCA, and whether the performance measures accurately reflect EPA’s assurance that the objectives of TSCA are met. The OIG report is available online.

According to the report, OIG found that EPA does not have integrated procedures and measures in place to ensure that new chemicals entering commerce do not pose an unreasonable risk to human health and the environment. OIG states that EPA’s New Chemicals Program has limitations in three processes intended to identify and mitigate new risks — assessment, oversight, and transparency. The Program “is limited by an absence of test data and a reliance on modeling because TSCA does not require upfront testing as part of a Premanufacture Notice (PMN) submission.” Although PMN submitters must submit health and safety data in their possession and a description of data known to or reasonably ascertainable by the submitter at the time of its submission, the majority of PMN submissions do not include chemical toxicity or environmental fate data.

OIG states: “Oversight of regulatory actions designed to reduce known risks is a low priority, and the resources allocated by EPA are not commensurate with the scope of monitoring and oversight work.” According to OIG, EPA’s procedures for handling confidential business information (CBI) requests “are predisposed to protect industry information rather than to provide public access to health and safety studies.”

OIG concludes that OPPT’s and OECA’s respective performance measures for managing risks from new chemicals “do not accurately reflect program performance in preventing risk, nor do they assure compliance. In cases where full information does not exist or analyses are limited, OPPT reports the new chemicals as not having risk, while the limitations in the measure are not disclosed. OECA’s performance measure is not outcome based; rather, the measure tracks program activities.”

OIG recommends that the Office of Prevention, Pesticides, and Toxic Substances establish criteria for selecting chemicals or classes of chemicals for low-level exposure and cumulative risk assessments, and develop CBI classification criteria to improve EPA’s transparency and information sharing. OIG also recommends that OECA develop a management plan for core TSCA enforcement “that includes training, consistent enforcement strategies across regions for monitoring and inspection protocols, and a list of manufacturers and importers of chemicals for strategic targeting.” According to the OIG report, EPA agreed with OIG’s recommendations.


The report, in its “Why We Did This Review” section, states that its purpose is to determine “how well EPA’s processes for oversight and regulation meet the objectives of TSCA.” Fair enough. The “TSCA objective” as stated in the report is to “ensure” that new chemicals entering commerce “do not pose unreasonable risk” to human health and the environment. This standard, however, is not generally applicable to all new chemicals, a fact the report neglects to note. Rather, the statute sets up the need for an affirmation of “no unreasonable risk” only at specific points in TSCA Section 5. Specifically, EPA is required to make a “will not present an unreasonable risk” determination in developing exemptions (TSCA Section 5(h)(4)), and the regulated entity is required to make a “will not present” showing in submitting a significant new use notification for a TSCA Section 5(b)(4) listed chemical (TSCA Section 5(b)(2)(B)).

The report goes on to claim that, in its performance measures, “OPPT reports the new chemicals as not having risk.” Perhaps this is merely evidence of sloppy editing, but as is made clear in the box on page 13 of the report, the measure reports new chemicals that “do not pose unreasonable risks.” While this distinction may be difficult for some to appreciate fully, it is meaningful to OPPT New Chemicals Program staff in that their efforts are properly focused on unreasonable risks, not all risks.

After finding limitations in the available data and in EPA’s assessment processes for new chemicals, the report goes on to recommend actions to deal with the deficiencies it had identified. The report’s only recommendation regarding assessment aspects is that EPA “establish criteria for selecting chemicals or classes of chemicals for low-level exposure and cumulative risk assessment.” The recommended actions, given the basic limitations in the test data EPA has available to it on new chemicals (and as discussed in the report), offers little of practical value and more likely indicates an acknowledgement of the current political context of the report.

It is also of note that the references cited in the report do not include the several Government Accountability Office reports, which, in a much more thoughtful and analytic manner, investigated aspects of the New Chemicals Program (most recently in 2005 online). If interested in better understanding the challenges faced by EPA staff and the strengths and weaknesses in the New Chemicals Program, the reader should consult these reports.