Integrated Science Assessment for Lead (Pb)

AGENCY:

Environmental Protection Agency.

ACTION:

Notice; call for information.

SUMMARY:

The Environmental Protection Agency (EPA) is announcing that the Office of Research and Development's National Center for Environmental Assessment (NCEA) is preparing an Integrated Science Assessment (ISA) as part of the review of the National Ambient Air Quality Standards (NAAQS) for Lead (Pb). This ISA is intended to update and revise, where appropriate, the scientific assessment presented in the Air Quality Criteria for Lead (EPA/600/R-5/144aF), published on October 1, 2006. Interested parties are invited to assist the EPA in developing and refining the scientific information base for the review of the Pb NAAQS by submitting research studies that have been published, accepted for publication, or presented at a public scientific meeting.

DATES:

All communications and information should be received by EPA by April 30, 2010.

ADDRESSES:

Information may be submitted electronically, by mail, by facsimile, or by hand delivery/courier. Please follow the detailed instructions as provided in the section of this notice entitled SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT:

For details on the period for submission of research information from the public, contact the Office of Environmental Information (OEI) Docket; telephone: 202-566-1752; facsimile: 202-566-1753; or e-mail: OAR.Docket@epa.gov. For technical information, contact Ellen Kirrane, Ph.D., NCEA, telephone, 919-541-1340; facsimile: 919-541-2985; or e-mail: kirrane.ellen@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Information About the Project

Section 108 (a) of the Clean Air Act directs the Administrator to identify pollutants that meet certain criteria, including emissions which “may reasonably be anticipated to endanger public health and welfare” and whose presence “in the ambient air results from numerous or diverse mobile or stationary sources,” and to issue air quality criteria for them. These air quality criteria are to “accurately reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare which may be expected from the presence of such pollutant in the ambient air * * *.” Welfare effects as defined in section 302(h) (42 U.S.C. 7602(h)) include, but are not limited to, “effects on soils, water, crops, vegetation, man-made materials, animals, wildlife, weather, visibility and climate, damage to and deterioration of property, and hazards to transportation, as well as effects on economic values and on personal comfort and well-being.” Under section 109 of the Act, EPA is then to establish National Ambient Air Quality Standards (NAAQS) for each pollutant for which EPA has issued criteria. Section 109(d) of the Act subsequently requires periodic review and, if appropriate, revision of existing air quality criteria to reflect advances in scientific knowledge on the effects of the pollutant on public health and welfare. EPA is also to revise the NAAQS, if appropriate, based on the revised air quality criteria.

Lead (Pb) is one of six “criteria” pollutants for which EPA has established NAAQS. Periodically, EPA reviews the scientific basis for these standards by preparing an Integrated Science Assessment (ISA), formerly called an Air Quality Criteria Document (AQCD). The ISA and its supplementary annexes are the scientific basis for the additional technical and policy assessments that form the basis for EPA decisions on the adequacy of current NAAQS and the appropriateness of new or revised standards. Early steps in this process include announcing the beginning of this periodic NAAQS review and the development of the ISA, and EPA requesting that the public submit scientific literature that they want to bring to the attention of the Agency as it begins this process. The Clean Air Scientific Advisory Committee (CASAC), an independent science advisory committee mandated by the Clean Air Act and part of the EPA's Science Advisory Board (SAB), is charged with independent expert scientific review of EPA's draft ISAs. As the process proceeds, the public will have opportunities to review and comment on drafts of the Pb ISA. These opportunities will also be announced in the Federal Register.

The Agency is interested in obtaining information concerning toxicological studies of effects of controlled exposure to Pb on laboratory animals and in vitro systems, epidemiologic (observational) studies of health effects associated with exposures of human populations to Pb, and ecological effects of Pb exposure. Information particular to air-related pathways, including those involving deposition, are also of interest to the Agency. EPA also seeks recent information in other areas of Pb research such as toxicokinetic modeling, exposure assessment and exposure assessment methodologies, sources and emissions, chemistry and physics, analytical methodology, fate and transport in the environment, ambient concentrations, including concentration changes in response to changes in Pb deposition, and effects on public welfare or the environment. This and other selected literature relevant to a review of the NAAQS for Pb will be assessed in the forthcoming Pb ISA.

As part of this review of the Pb NAAQS, EPA intends to sponsor a workshop in May 2010, which will be announced in the Federal Register, to highlight significant new and emerging Pb research, and to make recommendations to the Agency regarding the design and scope of the review of the air quality criteria and the primary (health-based) and secondary (welfare-based) Pb standards to ensure that it addresses key policy-relevant issues and considers the new science that is relevant to informing our understanding of these issues. In addition, other opportunities for submission of new peer-reviewed, published (or in-press) papers will be possible as part of public comment on the draft ISAs that will be reviewed by CASAC.

II. How To Submit Comments to the Docket at http://www.regulations.gov

Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2010-0108 by one of the following methods:

• http://www.regulations.gov: Follow the on-line instructions for submitting comments.
• E-mail: OAR.Docket@epa.gov.
• Fax: 202-566-1753.
• Mail: Office of Environmental Information (OEI) Docket (Mail Code: 2822T), U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. The phone number is 202-566-1752.
• Hand Delivery: The OEI Docket is located in the EPA Headquarters Docket Center, Room 3334 EPA West Building, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center 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 202-566-1744. Such deliveries are only accepted during the docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information.

If you provide comments by mail or hand delivery, please submit three copies of the comments. For attachments, provide an index, number pages consecutively with the comments, and submit an unbound original and three copies.

Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-2010-0108. Please ensure that your comments are submitted within the specified comment period. Comments received after the closing date will be marked “late,” and may only be considered if time permits. It is EPA's policy to include all comments it receives in the public docket without change and to make the comments available online at http://www.regulations.gov,, including any personal information provided, unless a 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 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. For additional information about EPA's public docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.

Docket: 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 materials, such as copyrighted material, are 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 OEI Docket in the EPA Headquarters Docket Center.