EPA Office of Inspector General Critiques TSCA Implementation – Report Published


Source: SOCMA
Related Topics: Toxic Substances Control Act (TSCA) US Environmental Protection Agency

Last week, the EPA Office of Inspector General (OIG) published a report entitled “EPA Needs a Coordinated Plan to Oversee Its Toxic Substances Control Act Responsibilities”.  The OIG is basically an independent auditing entity that is part of EPA, but gets its funding from Congress, separate from EPA.  In general, the intent of the report is to critique the EPA’s implementation of TSCA.  It puts emphasis on shortcomings with TSCA, however, but does still talk about problems with how the New Chemicals Program is implemented and a lack of coordination with the Office of Enforcement and Compliance Assurance (OECA). 

The main issues the report touch on include Data Collection authority on new chemicals, Oversight of Regulatory Actions, Performance Metrics, Resources, and CBI Issues. A brief look at the report criticisms are as follows:

Data Collection – the EPA lacks authority under TSCA, since minimum data sets are not required and EPA must make a risk finding before requesting additional data.  Most new chemical submissions lack toxicity data and human health modeling tools are limited.

Oversight of Regulatory Actions –  a lack of resources and a lack of awareness of who is in the broad TSCA regulated community. Also, a lack of collaboration between OPPT and OECA.

Performance Metrics – the agency uses 8(e) submissions of actual adverse toxicity data to ensure its prior regulatory decisions on identical chemicals, that may have lacked data at the time of review, were sound and reflect what the new data illuminate.  The problem is that the relative number of 8(e) data submissions is small compared to the number of new chemicals that go through the review process and that the new data may provide EPA with insights on a chemical that was reviewed many years prior to the actual 8(e) submission. There could also be unidentified endpoints not covered in the submission.  Also, not all adverse data may be submitted.

Resources – not commensurate with costs of running the New Chemicals Program and problems with the fee cap of $2500 for a PMN.  The report noted that there are, “government-wide efforts to appropriately align program costs to those who benefit directly from such services.” An effort to raise the fee to $12500 was mentioned.

CBI - requirements are slanted to favor industry confidentiality, over public disclosure of health and safety data. Over-claiming of CBI on PMNs and 8(e) submissions are a problem.  It was also noted that industry can choose the length of time for CBI protection.

The following, are highlights of corrective measures that the evaluation directed to various levels of leadership at the agency.  It was noted that a better job could be done coordinating the new chemicals program office with the enforcement one.  Criteria and procedures outlining what chemicals or classes of chemicals will undergo risk assessments for low-level and cumulative exposure should be established. Risk-assessment tools should be updated as new techniques become available.  Detailed CBI criteria should be established and a time limit on claims, allowing for eventual public access.  The agency should request statutory authority to lift the fee cap on PMNs. Finally, it was noted that a list of regulated entities would help aid enforcement.
The agency concurred with the findings and agrees to implement the suggestions.

Click here to access the report.

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