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EPA Seeks Public Comments on Risk Assessment, Due June 23, 2004,
After Industry and OMB Charge Current Methods Are Overly Protective
(Beyond Pesticides, June 21, 2004) EPA is interested in receiving the public's thoughts on risk assessment by June 23, 2004, and the agency released an EPA staff paper entitled An Examination of EPA Risk Assessment Principles and Practices (193 pages) in March (69 FR 15326-15328). It is a product of an EPA staff review of how risk assessment is conducted at EPA --created in response to an Office of Management and Budget (OMB) review and 2003 annual report to Congress, which was heavily influenced by the American Chemistry Council (ACC), according to Charles Schmidt, writing in the June 8, 2004 (Vol.112, No. 8) issue of Environmental Health Perspectives.

Mr. Schmidt is a freelance science writer who worked as a toxicologist with a major environmental consulting firm where he specialized in risk assessment. He says that OMB relied heavily on ACC's criticism of "agency approaches to defaults and other methods to address uncertainty that the ACC claims are overly conservative and protective."

The EPA staff recommendations grow out of a task force charged with reviewing how risk assessments are being performed at the agency. While EPA is not looking for comments to amend the document, the agency says it wants interested parties to consider how EPA can strengthen and, where appropriate, improve its risk assessment practices. The EPA Science Advisor and other senior EPA officials requested this review to further the discussion and examination of some broad questions about risk assessment. The staff paper also discusses public comments relevant to EPA that were submitted in response to OMB's request for public comment on risk assessment procedures in the federal government (68 FR 5492-552, February 3, 2003). EPA assembled a group of risk assessment professionals from across the agency to examine EPA's risk assessment principles and practices and to prepare the staff paper. The paper does not represent official EPA policy.

EPA said it released the staff paper as the first step in a multi-step process in which EPA intends to engage interested parties in a dialogue about risk assessment principles and practices to improve the practice of risk assessment. (See EPA Risk Assessment Principles and Practices memorandum.) Accordingly, EPA is requesting public comment on the risk assessment principles and practices described in the paper with the objective of identifying particular issues for future dialogue. Future dialogue on particular issues may come, for example, in discussions under the auspices of EPA's Science Advisory Board, other consultative groups, and professional societies with a focus on risk assessment and with states, non-governmental organizations, and tribal groups. EPA is interested in suggestions for other avenues for dialogue as well.

According to Mr. Schmidt, "When combined, defaults and safety factors can have the effect of magnifying calculated risk levels to a degree that many in industry believe is unreasonable." On the other hand, environmentalists have long argued that the safety factors may actually be too low because of the unknown effects on untested health and environmental effects, the impact of unstudied mixtures, uncalculated cumulative and synergistic effects of chemical exposures, the unevaluated effect of chemical exposures on sensitive population groups, etc. Because of the high degree of uncertainty associated with health impacts from typical chemical exposures and the severe limitations with uncertain risk assessment numbers, many communities and environmental organizations are embracing the precautionary principle, thus seeking to avoid, use and exposure to toxic chemicals rather than rely on fuzzy numbers. Quoting from Mr. Schmidt, "An opportunity to better characterize uncertainty, the [EPA] paper suggests, is provided by probabilistic modeling, a statistics-based method for risk assessment long championed by industry." Still, EPA acknowledges that to use this modeling a fundamental set of data is needed which the agency may not have.

TAKE ACTION: Let your concerns about risk assessment be heard by EPA, even if it is a brief statement. You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket identification number (Docket ID No. ORD 2004-0004) in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked ``late.'' EPA is not required to consider these late comments; however, late comments may be considered since the staff paper represents the first step of a multi-step process.
1. Electronically. If you submit an electronic comment as prescribed below, EPA recommends that you include your name, mailing address, and an e-mail address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.
i. EDOCKET. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EDOCKET at http://www.epa.gov/edocket, and follow the online instructions for submitting comments. Once in the system, select ``search,'' and then key in Docket ID No. ORD-2004-0004. The system is an ``anonymous access'' system, which means EPA will not know your identity, e-mail address, or other contact information unless you provide it in the body of your comment.
ii. E-mail. Comments may be sent by electronic mail (e-mail) to [email protected], Attention Docket ID No. ORD-2004-0004. In contrast to EPA's electronic public docket, EPA's e-mail system is not an ``anonymous access'' system. If you send an e-mail comment directly to the Docket without going through EPA's electronic public docket, EPA's e-mail system automatically captures your e-mail address. E-mail addresses that are automatically captured by EPA's e-mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket.
iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit II.A.2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption.
2. By Mail. Send your comments to: U.S. Environmental Protection Agency, ORD Docket, EPA Docket Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, Attention Docket ID No. ORD-2004-0004.
3. By Hand Delivery or Courier. Deliver your comments to: EPA Docket Center (EPA/DC), Room B-102, EPA West Building, 1301 Constitution Ave., NW., Washington DC, Attention Docket ID No. ORD 2004-0004; (note: this is not a mailing address). Such deliveries are only accepted during the Docket's normal hours of operation as identified in unit II.B.