EPA’s Backlog Stalls Regulation and Enforcement of Nearly 255 Chemicals

The United States EPA’s Integrated Risk Information System (IRIS) has often been criticized for lacking transparency in their evaluation processes, allowing influence from other governmental agencies, and unexplained delays in producing assessments. The latest condemnation comes from a report published by the Center for Progressive Reform, a nonprofit organization, which chastises EPA for falling behind in completing statutory mandates for 255 chemicals. As an example of the incompleteness of IRIS, the report notes that EPA has not developed inhalation reference concentrations (RfCs) for approximately 77 known hazardous air pollutants.

This is not the first time that the problems with IRIS have been reported. In 2008, the Government Accountability Office (GAO) published a report detailing that despite EPA’s efforts, the backlog on chemical assessments have not diminished. In fact, the GAO implied that Office of Management and Budget requirement of interagency review would only further hamper the assessment process and limit IRIS’s credibility. Some of the GAO recommendations included clearly defining and documenting the IRIS process to minimize the need for revision, setting defined time-limits for interagency review, and conducting assessment with available studies and only suspending assessments to await completion of scientific studies in exceptional circumstances.

In addition, a review of the IRISTrack website demonstrated the validity of this criticism. For example, the acrylonitrile and benzo[a]pyrene assessments began in January and December 1998, respectively, and the finalized assessments are still pending. However, the assessment for chromium VI was initiated in November 2008 and is scheduled to be finalized in the third quarter of FY11. While the quick turnaround of the chromium VI assessment is unusual for IRIS, the majority of the ongoing assessments are scheduled to be finalized sometime during FY11, so, perhaps, this is an indication that the IRIS process is improving with the recent revisions.

In 2009, EPA Administrator Lisa Jackson announced reforms to the IRIS process including a streamlined review process so that assessments are available within two years of the start date. The reform involved reducing the timeframes for assessment and making the written comments from other governmental agencies public. These revisions allowed the EPA to regain a stronger control over the IRIS process, while still providing transparency and integrity.

While the recent reform of the IRIS process is a step in the right direction, there will still be long delays in producing assessments because EPA is hindered by a lack of toxicity data for many of the chemicals yet to be assessed. However, this may soon change with the upcoming TSCA revisions placing the burden on industry to conduct studies to fill in data gaps on their products and chemicals. Whether EPA is prepared to handle the influx of data from various industries on numerous chemicals that will emerge after the TSCA revisions are finalized is still a question to be answered. Once EPA begins receiving the industry data, there will be an initial struggle to review and manage the incoming information until EPA learns to adapt, which will undoubtedly result in further delays in the IRIS assessment process. How long the period of adjustment will last will depend on how well the IRIS program is managed.