EPA Regains Control of Toxic Chemical Studies

The U.S. Environmental Protection Agency (EPA) is changing the way it studies the health effects of industrial chemicals in an attempt to quicken the pace at which new assessments are completed and to limit political interference in the scientific process.

Every year, hundreds of new chemicals are introduced into commerce, but chemical manufacturers and users rarely provide detailed health information. EPA's Integrated Risk Information System (IRIS) studies those chemicals and posts final risk assessments on the EPA website at cfpub.epa.gov/ncea/iris/index.cfm [1].

EPA announced [2] May 21 that it is removing procedural steps to shorten the time frame for completing assessments. A memo [3] from EPA Administrator Lisa Jackson says, "While still robust, the assessment development process will be shortened to 23 months, speeding the availability of IRIS assessments to the risk assessor community and the public."

Delay has plagued the IRIS program in recent years. EPA expects to complete five assessments later in 2009 (one was completed in February). All five have been in development for several years, with timeframes ranging from four years to over ten years, according the IRIS website.

In part because of the length of the process, EPA has made little progress in finishing new assessments. From 2004 through 2008, the agency completed assessments for only 16 substances.

To shorten the process, EPA is removing several steps added during the Bush administration. In 2004, the White House Office of Management and Budget (OMB) began reviewing draft assessments both before and after the studies underwent an external peer review. EPA calls the phases "interagency review" since OMB shares the draft assessments with other agencies inside the federal government.

The review gave the White House and other agencies an opportunity to block new assessments. According to a Government Accountability Office (GAO) report [4] released in March 2008, OMB forced EPA to halt work on five IRIS assessments because it disagreed with the agency's decision to study the health effects of short-term exposure to those chemicals.

The interagency review also delayed the IRIS process. Recent interagency reviews have typically taken six months to one year.

In 2008, the Bush administration again revised [5] the process to empower other agencies. If EPA assessed a chemical deemed critical to the mission of another agency, that agency could demand further review of the substance. Critics feared agencies like the Department of Defense, a major user of industrial chemicals, would have an incentive to delay or suppress conclusions showing a substance's risks.

EPA will no longer allow other agencies to receive special treatment if they believe a chemical is mission critical.

However, EPA is preserving a role for the White House in the revised process, giving it two opportunities to review IRIS assessments before they are officially finalized.

EPA did not indicate why it believes White House review is necessary. It is unclear what value, if any, a White House review adds to the process, particularly after the assessment has been peer reviewed. It is also unclear who will lead the review for the White House. OMB may continue to review drafts, or other offices, such as the Office of Science and Technology Policy, may play a bigger role.

In the past, employees inside the IRIS program have expressed concern with OMB's involvement. Comments [6] on the 2008 GAO report complained that the OMB review delayed the completion of assessments and said OMB's comments "can be very extensive and troubling to address."

To mitigate concern, EPA insists it will maintain control over the process, including the White House review, at all times. The revised process also sets a time limit of 45 days for each review phase. EPA also says that comments on draft assessments should focus solely on science.

EPA is also making the process more transparent: Written comments submitted to EPA during the White House review will be made public. The disclosure requirement may help fend off any potential political manipulation.

Rep. Brad Miller (D-NC), Chairman of the House Science and Technology Committee's Subcommittee on Investigations, applauded [7] the revisions, but added, "The assessment of the health effects of environmental exposures should be entirely scientific, not at all political. Scientific peer review is useful, political review is not." Miller plans to hold a hearing on the revisions to the IRIS process June 11.

In addition to the process changes, Jackson said she hoped to infuse more resources into the agency. Jackson noted that President Obama's FY 2010 budget request calls for an additional $5 million and 10 new employees to help the program reduce the backlog of substances awaiting study.