Changes to US chemical review procedures

Recent changes to the US Environmental Protection Agency’s (EPA) main tool for assessing the health effects of chemicals could significantly lengthen the time needed to review them, a congressional watchdog has warned.

The EPA announced changes to its Integrated Risk Information System (Iris) in April, giving federal agencies and the public 45 days to identify additional information on a chemical for EPA’s consideration. The changes also allow federal agencies to suspend chemical assessments for up to 18 months to fill data gaps or eliminate uncertainty factors.

But the Government Accountability Office’s natural resources and environment director, John Stephenson told a congressional committee that the changes mean it could take the agency up to six years to complete chemical assessments - around a year longer than the current average.

’While it is important to ensure that assessments consider the best science, EPA has acknowledged that waiting for new data can result in substantial harm to human health, safety, and the environment,’ Stephenson told  the House of Representatives’ Science and Technology Committee at a 21 May hearing.

Approximately 700 new chemicals enter the market each year,  but a total of only four IRIS assessments were completed in fiscal years 2006 and 2007 and the EPA’s changes will aggravate the situation, Stephenson said. The GAO believes IRIS could become obsolete because delays in EPA’s assessments have led to a backlog of 70 reviews.

At the hearing, EPA’s assistant administrator for research and development, George Gray, acknowledged that  IRIS delays are a ’long-standing problem’. The revised procedures were designed to help address the delays by allowing earlier input from various stakeholders - like EPA programme and regional offices, other agencies and scientific organisations, he explained.

However, lawmakers remained unconvinced. ’With the new process .we may view two new entries a year as the golden era of IRIS assessments,’ said Representative Brad Miller, the North Carolina Democrat who chairs the House committee’s Investigations and Oversight Subcommittee.

Ongoing problems

The controversy is just the latest in series of problems for the EPA. Most recently, a senior agency scientist claimed that she was forced to resign from her post as head of EPA’s Region 5 Office in Chicago because she clamped down on manufacturing giant Dow Chemical.

Mary Gade told the Chicago Tribune on 2 May that she resigned after two aides to EPA’s administrator, Stephen Johnson, took away her powers as regional administrator and told her to quit or be fired by 1 June. The action, she said, followed prolonged tensions between her and Dow over dioxin contamination surrounding the company’s Midland, Michigan plant.

The leaders of two powerful congressional panels - the Senate Environment and Public Works (EPW) Committee, and the House Energy and Commerce Committee - are investigating Gade’s resignation.

During a Senate EPW Committee hearing on 7 May, Rhode Island Democrat Senator. Sheldon Whitehouse called Gade’s departure ’an alarming signal’.

Dow pleads ignorance about Gade’s departure from EPA. However, the company acknowledges that tensions existed between Dow and EPA over local dioxin and furan contamination. ’We wanted EPA to apply the same rules, policies and guidelines that were applied elsewhere,’ Dow spokesperson John Musser told Chemistry World.

Gray also said he had no first-hand knowledge of Gade’s dismissal when questioned by lawmakers. He described the agency’s decision as a confidential ’internal personnel matter’.

The EPA has also faced criticism over a survey released by a lobby group known as the Union of Concerned Scientists in which nearly 900 EPA scientists reported political interference in their work.

At the Senate EPW meeting, Gray acknowledged that the survey findings were troubling. ’That is unacceptable to me as the head of the agency’s science and technology office, and as the agency’s science advisor,’ he stated. But, he dismissed the data as ’based on individual opinions and anecdotes that really are not a statistically appropriate view of EPA’.

He added that scientific issues facing EPA typically involve both science and policy considerations. ’There is no single right answer that comes out of the scientific process,’ Gray told senators. ’The data that are available have to be weighed, analyzed, and considered in their entirety; we get advice to help us do that, but ultimately, it is the administrator’s decision.’

Rebecca Trager, US correspondent for Research Day USA