EPA toxicity risk assessments in crisis

Political interference and lack of transparency taint science and delay assessments.

The U.S. EPA's recently announced revisions to the way toxic chemicals are assessed will institutionalize the political interference and secrecy that have already damaged the credibility of the agency, according to experts testifying at a hearing before the U.S. Senate. The hearing was convened in April to discuss a report (PDF Size: 1.08 MB) from the U.S. Government Accountability Office (GAO), a congressional watchdog, on EPA's efforts to refashion the Integrated Risk Information System (IRIS). GAO noted that the EPA's changes would make the popular IRIS database obsolete and recommended that Congress should consider requiring the agency to withdraw the modifications.

The IRIS database contains EPA's scientific position about the human-health impacts of more than 540 chemicals, including arsenic and PCBs. It was created in 1985 and includes toxicity assessments on each chemical; these assessments form the basis for EPA regulations. EPA's work on IRIS is so well respected that the assessments are incorporated into state programs in the U.S. as well as in the policies of other countries, the agency notes.

Without obtaining public input, on April 10, EPA announced its revisions to the IRIS process, which became effective immediately. The modifications were designed to make IRIS more transparent, objective, and streamlined, the agency wrote. The changes were spearheaded by EPA's assistant administrator for the Office of Research and Development (ORD), George Gray, who, shortly after being sworn in as ORD's leader, said he would institute IRIS improvements. "An IRIS assessment is not pure science, it's a mix of science and science policy," Gray told ES&T.

But critics say that EPA inserted formal policies to allow other federal agencies, such as the U.S. Department of Defense (DOD) and the U.S. Department of Energy, to be involved in each assessment at almost every step. For example, the White House Office of Management and Budget (OMB), which oversees the federal regulatory process, is provided with seven opportunities, up from two, to have its say on IRIS assessments.

"We found that the IRIS database is at serious risk of becoming obsolete because EPA has not been able to routinely complete timely credible assessments or decrease its backlog of 70 ongoing assessments," said John Stephenson, director of natural resources and environment at GAO, in testimony before the Senate Environment and Public Works Committee. GAO also noted that the upgraded OMB review will bog down IRIS assessments and hinder EPA's independence, Stephenson said. OMB, without giving any reasons, once ordered EPA to terminate five IRIS assessments, he added.

EPA already has slowed down the pace of its IRIS assessments, EPA staffers note. The agency sent 32 draft assessments for external review during the past 2 years but finalized only 4 of them, according to GAO. Now it takes an average of 7 years to conduct an IRIS assessment, but EPA can complete a virtually identical internal review, known as the Provisional Peer Reviewed Toxicity Values, in only 1 year, added a former EPA scientist, who spoke to ES&T on condition of anonymity.

"The revised process defines comments from federal agencies as 'deliberative', which means they will not become part of the public record and will be exempt from Freedom of Information Act requests," says Kyla Bennett, director of the New England Public Employees for Environmental Responsibility, an advocacy group.

Lynn Goldman, who is an epidemiologist at Johns Hopkins University and is a former assistant administrator of EPA's Office of Prevention, Pesticides, and Toxic Substances, noted that EPA's refusal to approve chemical assessments has affected individuals already. "My point is that efforts to suppress science have real consequences for the protection of public health," Goldman said at the hearing. In 2004, EPA scientists had nearly completed a 7-year assessment of formaldehyde, a compound found in particle board that was declared a known human carcinogen in 2006 by the International Agency for Research on Cancer.

But the IRIS process was postponed at the behest of the formaldehyde industry, while the Chemical Industry Institute of Toxicology (CIIT), an industry-sponsored research organization, published its own assessment on the health effects of formaldehyde, Goldman said. In 2004, EPA incorporated the CIIT assessment into its rule about hazardous air pollution caused by fiberboard, without the concurrence of EPA scientists or EPA's Science Advisory Board.

In the wake of Hurricanes Katrina and Rita in 2005, the government provided 120,000 trailers to those who lost their homes. Those trailers made of particle board have been found to contain significant quantities of formaldehyde, which may have made the occupants ill. EPA still has not completed the formaldehyde assessment.

Expanding OMB's role and inviting federal agencies to meddle with IRIS in secret inject "political science" into the IRIS process, Goldman added. Agencies, such as DOD, are responsible for meeting EPA standards when carrying out waste cleanups. Because of this, these agencies should not have a veto over EPA's scientific conclusions, she said.

"There are some fairly serious misunderstandings in the GAO report," Gray said. The new process will allow EPA to receive more scientific input from other agencies; this will improve each chemical assessment, he added. But Committee Chair Sen. Barbara Boxer (D-CA) said that if there is no action to improve the program, Congress will step in and start banning chemicals. —JANET PELLEY