Industry, Agencies Struggle To Revise EPA’s Risk Assessment Process

One year after EPA introduced a new process that was designed to speed its most important chemical risk assessments, federal agencies and industry groups are struggling to win a greater role and more time to participate as the agency is rejecting calls for changes and the critics acknowledge they have limited means to intervene in the process.

Among the changes being sought are requirements for EPA to respond in writing to agencies’ comments on draft versions of the assessments; subject the assessments to strict data quality standards; provide states with a more formal role in the review process and allow federal agencies more time to participate.

Industry sources say the National Aeronautics & Space Administration (NASA) is leading efforts by federal agencies to schedule a meeting with EPA and the White House Office of Management & Budget (OMB) to “air grievances” about the year-old process for reviewing the agency’s risk assessments.

NASA has “raised a lot of concern about the fact the process seems to be truncated” and no longer “allows for full input” from the other agencies, one source says.

A NASA spokesman did not return a call seeking comment by press time.

EPA Administrator Lisa Jackson last May unveiled a new process for creating Integrated Risk Information System (IRIS) assessments, used by EPA and state regulators to set water, cleanup and other regulations. The new process was intended to provide for input and comment from other agencies and the public while ensuring that EPA keeps the process on a set two-year time line so assessments are not endlessly delayed.

It also allowed for “independent external” scientific peer review -- though agency officials long resisted calls to allow for a National Academy of Sciences (NAS) review of its formaldehyde assessment -- agreeing to it only after Sen. David Vitter (R-LA) blocked confirmation of EPA’s research chief Paul Anastas.

Jackson instituted the changes in response to concerns raised by the Government Accountability Office (GAO), NAS and congressional Democrats who charged that during the Bush administration, other agencies played too great a role in reviewing -- and stalling -- EPA’s assessments.

A particularly critical 2008 report from GAO said the IRIS program was so slow as to be obsolete, highlighting a dozen assessments that had been in progress for 10 years or more, including those for dioxin, perchlorate and tetrachloroethylene. The report added that changes made in 2005 to allow other agencies and OMB to review draft IRIS documents before the public further delayed the process. These changes were made in response to concerns from the Defense Department (DOD), Energy Department and other federal agencies that they were not able to review the assessments before they were publicly released.

But EPA officials chaffed at the restrictions. Peter Preuss, who, as director of EPA’s National Center for Environmental Assessment, oversees the IRIS program, called on the Obama administration to “get rid of” the Bush administration’s process (Inside EPA, December 16, 2008).

Since the new process was installed, EPA has issued several high-profile draft assessments, including those for arsenic, methanol, trichloroethylene (TCE) and ethyl butyl tertiary ether as well as methodological approaches for assessing risks for dioxins and polycyclic aromatic hydrocarbons (PAHs). The agency is also poised to soon issue several other high-profile assessments, including those for formaldehyde and dioxin.

But the assessments are prompting significant concerns because they are likely to drive significantly stricter regulatory requirements. For example, industry and other sources are concerned that EPA’s draft assessment of arsenic -- which proposes to strengthen the agency’s estimate of the metal’s cancer risks by a factor of 17 times -- could drive prohibitive and unattainable new regulatory standards for drinking water, fertilizer, pesticides and other pollution sources.

But industry sources are struggling to get an EPA Science Advisory Board (SAB) panel reviewing the document to consider new data that they say shows less risk than EPA claims because the agency has written the panel’s charge so narrowly. Industry sources are now turning to Capitol Hill and the U.S. Department of Agriculture (USDA) to help them delay the assessment (Inside EPA, April 30).

One industry source says USDA could have serious concerns because EPA’s proposed standard, if finalized, brings into question the safety of food grown in the United States, where soil can exceed the proposed arsenic standard,

But in a sign of how difficult it is for critics to win changes, some sources are acknowledging that they may not be able to win congressional support to intervene -- at least on the arsenic issue. We are “trying to figure out what to do” about the assessment, a Senate source says. In the meantime, Senate staff will request additional information from EPA and are also “reaching out to other stakeholders to get this thing done.”

In comments released so far, some federal agencies have also criticized EPA’s draft assessments. DOD, for example, has criticized EPA’s draft assessment of the paint stripper dichloromethane, for overstating the chemical’s cancer risk, and has raised similar concerns with TCE, OMB has criticized several of the recently released assessments, including arsenic and dichloromethane, and NASA has also weighed in, questioning the basis for EPA’s proposed methods for PAHs.

A longtime IRIS observer says that the GAO reports “infer the IRIS process suffered from over-involvement of other” agencies and OMB. “You can’t say that’s a theme anymore. It’s up to EPA now.” The source says the new process has only been in place for a year, and that it is too early to begin assessing how it is working and whether it should be further altered. But the source adds that “with more autonomy from OMB does come more responsibility,” and that “if the process does not work, it is up to [EPA’s research office] to address these issues.”

But another longtime IRIS observer says the process under the Bush administration was “rightfully criticized for taking too long” and allowing “too much control by the White House.”

An EPA spokeswoman says that “No changes to the announced IRIS process are contemplated.” Jackson has also reiterated her support for strict risk assessments and regulatory standards, telling Rep. Mike Simpson (R-ID) in February that she would rather provide financial assistance to communities that cannot afford new treatment requirements due to strict EPA standards rather than easing the standards.

“It’s EPA’s job to promulgate regulations that protect human health and the environment. And the levels of arsenic that are detrimental to human health and the environment are no different depending on which community you’re in,” she told a House panel Feb. 24.

To address their concerns, the critics are calling for several changes to EPA’s current process. For example, in comments on EPA’s draft assessment for dichloromethane, OMB calls on EPA to apply data quality requirements to its IRIS peer review -- a move that would require peer reviewers to ensure that any recommendations and scientific data under consideration meets strict standards for objectivity and reproducibility.

In its undated comments on dichloromethane, OMB reminded EPA that because of the “cutting edge” nature of its risk assessment, EPA should follow OMB’s “Final Information Quality Bulletin for Peer Review,” and also “consider barring participation by scientists with a conflict of interest” from the peer review process. The comments are available on InsideEPA.com.

In the same comments, OMB notes that other agencies have included language in their charges to scientific review panels that tracks with their data quality guidelines, language that OMB says “often focuses on whether or not the information in question is accurate, clear, complete, transparently and objectively described, and scientifically justified. We believe it may be useful for EPA to follow a similar approach and incorporate some of the language from your [information quality] guidelines into the formulation of the charge questions.”

A source with the Center for Regulatory Effectiveness, an industry-funded group that favors broad application of data quality requirements, says OMB is reminding EPA to apply Data Quality Act (DQA) requirements that data be objective and reproducible and that the agency advise reviewers that they should not inject any policy views on uncertainty or precaution into their review.

Under the DQA, an advisory committee, such as EPA’s Science Advisory Board, can make any recommendations they wish, “but the sponsoring agency can not use the report of an advisory committee unless the report is DQA-compliant,” the source says. Committees should make a determination that their reports are DQA-compliant, the source adds.

A DOD source indicates the Pentagon recommends that EPA provide written responses to the other agencies’ comments “so we can have a record of how EPA handled the comments.”

The Senate source notes that while the latest IRIS process still allows federal agencies to provide some comments on IRIS drafts, there is no similar avenue for state governments to comment on documents that can also impact them directly. The source points to EPA’s ongoing assessment of arsenic’s cancer risk as an example of an assessment with major potential impacts for state and local governments. -- Maria Hegstad