E8-18740. Guidance on the Development, Evaluation and Application of Environmental Models

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice of public comment period.

SUMMARY:

EPA is announcing a 30-day public comment period for an external review of its Guidance Document on the Development, Evaluation and Application of Regulatory Environmental Models (hereinafter Guidance Document). The EPA's Council on Regulatory Environmental Modeling (CREM) has developed the Guidance Document and its companion product, the Models Knowledge Base, to improve the quality, consistency and transparency of EPA models. These products were produced in draft form in November 2003 and have undergone a rigorous process of internal and external peer review. This revised draft of the Guidance Document builds on the recommendations of the Science Advisory Board review panel and the National Research Council report on Models in Environmental Regulatory Decision Making.

This Federal Register Notice is intended to solicit public comment on the Guidance Document. EPA is releasing this external review draft document solely for the purpose of public comment under applicable information quality guidelines. The guidance document has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency policy or determination. EPA will consider any public comments submitted in accordance with this notice when revising the document.

DATES:

Comments may be submitted in writing by September 12, 2008.

ADDRESSES:

The Guidance Document may be downloaded from the CREM Web site: http://www.epa.gov/​crem. Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2008-0597, by one of the following methods: http://www.regulations.gov. Follow the on-line instructions for submitting comments.

• E-mail: [e-mail].
• Mail: ORD Docket, Environmental Protection Agency, Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
• Hand Delivery: EPA Docket Center (EPA/DC), Room 3334, EPA West Building, 1301 Constitution Avenue, NW., Washington, DC 20460, Attention Docket ID No. EPA-HQ-ORD-2008-0597. Deliveries are only accepted from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. Special arrangements should be made for deliveries of boxed information.

Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-2008-0597. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected by statute through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA, without going through http://www.regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. 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. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in http://www.regulations.gov or in hard copy at the ORD Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC 20460. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is [phone], and the telephone number for the ORD Docket is [phone].

FOR FURTHER INFORMATION CONTACT:

Dr. Noha Gaber, Council for Regulatory Environmental Modeling, Office of the Science Advisor, 1200 Pennsylvania Ave, NW., Mail Code: 8105R, Washington, DC 20460; by telephone/voice mail at [phone]; Fax: [phone]; or via e-mail at [e-mail].

SUPPLEMENTARY INFORMATION:

To achieve its mission of protecting human health and safeguarding the natural environment, the U.S. Environmental Protection Agency (EPA) often employs mathematical models to study environmental systems and processes and to inform regulatory decision making. The EPA established the Council for Regulatory Environmental Modeling (CREM) in 2000 in an effort to improve the quality, consistency and transparency of EPA models. At the request of the EPA Administrator, the CREM developed the Draft Guidance Document on the Development, Evaluation and Application of Regulatory Environmental Models (hereinafter Draft Models Guidance, http://www.epa.gov/​ord/​crem/​library/​CREM%20Guidance%20Draft%2012_​03.pdf) and the Models Knowledge Base (hereinafter Models KBase, http://cfpub.epa.gov/​crem/​knowledge_​base/​knowbase.cfm)

While the Draft Models Guidance does not impose legally binding requirements on EPA or the public, it provides recommendations on the principles of good modeling practice, stressing the importance of model quality, documentation and transparency with the aim of helping to determine when and how a model can be used to inform a decision. The Draft Models Guidance was developed in close collaboration with members of the CREM, who represent the different EPA program and regional offices, and as such, the document represents the consensus view among EPA offices. The Draft Models Guidance was also evaluated and approved by the EPA's Science Policy Council, the Agency's forum for senior level policy deliberation and coordination on significant science issues.

Both the Draft Models Guidance and the Models KBase were issued in draft form in November 2003. By providing access to its tools and methods, the EPA increases transparency and can improve the public's understanding of how sound science is used to make environmental decisions. In short, these products are intended to help foster a culture of transparency in developing models.

In addition to internal review within Agency offices and regions, the CREM products have undergone an external review process. EPA's Science Advisory Board (SAB) formed a CREM Guidance Advisory Panel (hereinafter “the Panel”) to review the Draft Models Guidance and the Models KBase. Specifically, the Panel was given seven charge questions (which can be found at this URL: http://www.epa.gov/​fedreg/​EPA-SAB/​2003/​August/​Day-06/​sab20034.htm). The Panel concluded its review in 2006 (the report may be found at http://www.epa.gov/​sab/​panels/​cremgacpanel.html).

The CREM also commissioned the National Academy of Science (NAS) to assess evolving scientific and technical issues related to the selection and use of computational and statistical models in decision making processes at the EPA. The NAS report which provides advice on the management, evaluation and use of models at the EPA was released in 2007 (the report may be found at http://www.nap.edu/​catalog.php?​record_​id=​11972).

This revised draft of the Guidance Document builds on the recommendations of the Science Advisory Board review panel and the National Research Council report on Models in Environmental Regulatory Decision Making.

Dated: August 6, 2008.

George Gray,

EPA Science Advisor.