Tuesday, May 16, 2006

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DOD Seeks Interagency Review Before EPA Finalizes Children's Risk Plan

The Defense Department is seeking a sweeping interagency review of safety precautions included in EPA risk assessments designed to protect children’s health before the agency finalizes a draft framework that may expand EPA’s use of protective factors when assessing children’s risks, according to DOD officials and documents the department submitted to EPA.

DOD last month filed comments on EPA’s draft Framework for Assessing Health Risks of Environmental Exposures to Children, arguing that the document could expand EPA’s use of “margins of safety.” The safety margins are default values factored into risk assessments that aim to protect children, who may be more sensitive than adults to chemical toxicity. Safety margins generally lead to more stringent risk assessments, irking industry and other scientists who argue that in most instances, children and adults are equally susceptible to toxic chemicals.

DOD’s April 26 comments come as the department is challenging EPA and state regulatory efforts to assess risks for controversial chemicals including trichloroethylene, benzene, naphthalene and perchlorate. The chemicals contaminate soil and groundwater and have created significant cleanup liability for DOD.

The department is also seeking to influence the chemical risk data EPA includes in its Integrated Risk Information System (IRIS), which provides public access to information about chemical risks. The effort caused concern among congressional Democrats, who questioned whether DOD could provide objective scientific input into the IRIS standard-setting process, given the department’s role as a responsible party at many waste sites.

In its comments on the children’s risk guide, DOD challenges EPA’s risk management process by questioning the agency’s use of margins of safety, a core element of the draft framework.

DOD argues that EPA’s policy for setting margins of safety should be reviewed before the agency proceeds with the draft framework. “Because the technical considerations that underlie the derivation of margins of safety are based on EPA science policy that has not been reviewed for several years, we recommend a review of this science policy in the context of more recent advances in biomedical science,” the comments state.

EPA’s draft framework aims to provide a broad approach under which the agency can consider potential risks to children, including risks at various stages of development, according to the draft document. “Risk assessment using a life stage approach is a shift in perspective from the current methodology that focuses primarily on adults, and then, secondarily, looks for information that may suggest greater susceptibility from exposures to children and other subpopulations,” the draft document states.

The framework could be applied to broader risk assessments, or to develop a risk assessment specifically targeting children’s health, including those that set regulatory standards. It also identifies policy gaps in guidance for children’s health assessments.

DOD’s comments list six questions for the potential technical review. The first asks whether the safety factors are reasonable compared to human responses to chemicals used in medicine. Another question asks whether EPA should consider portioning a standard safety margin. Under this approach, EPA would apply a portion of a predetermined, maximum margin of safety to a specific scenario, according to a DOD spokeswoman. The approach differs from EPA’s current way of using safety margins, which require the agency to make many different mathematical adjustments to account for potential safety concerns, including susceptible subpopulations.

DOD’s comments also call for interagency “harmonization” of health risk assessments. DOD argues an interagency review is necessary because environmental health “is just one component of public health and prioritizing a broader suite of competing risks is an inter-agency responsibility.”

The White House Office of Management & Budget (OMB) has long sought to harmonize risk assessments, arguing that there are significant disparities in how various agencies develop risk estimates. A DOD spokeswoman notes that the department is seeking to assist OMB in its long-standing effort, claiming harmonization “will minimize inconsistencies and differences in risk assessments across agencies.” The spokeswoman says OMB would decide which federal agencies would be involved in any potential interagency review.

But in response to DOD’s concerns, an EPA source notes that such harmonization efforts have failed in the past because agencies develop risk assessments for a wide variety of purposes that are not necessarily aimed at the same goals.

Meanwhile, the Center for Regulatory Effectiveness (CRE), an industry-funded regulatory watchdog group, filed comments on the draft framework asking EPA to clarify whether and how the draft document complies with the Information Quality Act and OMB’s Peer Review Bulletin, which outline minimum requirements for agency documents that could have significant regulatory impacts.

CRE’s comments question whether EPA meets White House peer review and predissemination review requirements for the document. CRE says the draft framework could have a “clear and substantial impact on important policies or private sector decisions,” and argues it is subject to data quality and peer review requirements.

“This document isn’t on a lot of people’s radars,” a CRE source says. “I think that’s a mistake. It’s going to have an impact on every risk assessment EPA does that affects children’s health.”

Date: May 16, 2006