Skip to Content


Draft Integrated Science Assessment for Lead

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.


Notice of public comment period.


EPA is announcing the availability of a document titled, “Second External Review Draft Integrated Science Assessment for Lead” (EPA/600/R-10/075B). The document was prepared by the National Center for Environmental Assessment (NCEA) within EPA's Office of Research and Development as part of the review of the national ambient air quality standards (NAAQS) for lead (Pb).

EPA is releasing this draft document to seek review by the Clean Air Scientific Advisory Committee (CASAC) and the public (meeting date and location to be specified in a separate Federal Register Notice). The draft document does not represent and should not be construed to represent any final EPA policy, viewpoint, or determination. EPA will consider any public comments submitted in response to this notice when revising the document.


The public comment period begins February 2, 2012, and ends April 2, 2012. Comments must be received on or before April 2, 2012.


The “Second External Review Draft Integrated Science Assessment for Lead” will be available primarily via the Internet on the National Center for Environmental Assessment's home page under the Recent Additions and Publications menus at A limited number of CD-ROM or paper copies will be available. Contact Ms. Marieka Boyd by phone (919-541-0031), fax (919-541-5078), or email ( to request either of these, and please provide your name, your mailing address, and the document title, “Second External Review Draft Integrated Science Assessment for Lead” (EPA/600/R-10/075B) to facilitate processing of your request.


For technical information, contact Dr. Ellen Kirrane, NCEA; telephone: 919-541-1340; facsimile: 919-541-2985; or email:


I. Information About the Document

Section 108(a) of the Clean Air Act directs the Administrator to identify certain pollutants, which among other things, “cause or contribute to air pollution, which may reasonably be anticipated to endanger public health or welfare” 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 [a] pollutant in the ambient air. * * *” Under section 109 of the Act, EPA is to establish NAAQS for each pollutant for which EPA has issued criteria. Section 109(d) of the Act 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 or welfare. EPA is also required to periodically review and revises the NAAQS, if appropriate, based on the revised air quality criteria.

Pb is one of six principal (or “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). The ISA and its supplementary materials provide a comprehensive assessment of the current scientific literature pertaining to known and anticipated effects on public health and welfare associated with the presence of the pollutant in the ambient air, emphasizing information that has become available since the last air quality criteria review in order to reflect the current state of knowledge. As such, the ISA forms the scientific foundation for each NAAQS review and is intended to provide information useful in forming EPA judgments about the different elements of the NAAQS. The CASAC, an independent scientific advisory committee whose review and advisory functions are mandated by Section 109(d)(2) of the Clean Air Act, is charged (among other things) with independent scientific review of EPA's air quality criteria.

On February 26, 2010 (75 FR 8934), EPA formally initiated its current review of the air quality criteria for Pb, requesting the submission of recent scientific information on specified topics. Soon after, a science policy workshop was held to identify key policy issues and questions to frame the review of the Pb NAAQS (75 FR 20843). Drawing from the workshop discussions, a draft “Integrated Review Plan for the National Ambient Air Quality Standards for Lead” (EPA-452/D-11-001) (IRP) was developed and made available in late March 2011 for public comment and consultation with CASAC and was discussed by the CASAC via a publicly accessible teleconference consultation on May 5, 2011 (76 FR 20347, 76 FR 21346). The final IRP was released in December 2011 (76 FR 76972) and is available at

As part of the science assessment phase of the review, EPA held a workshop in December 2010 (75 FR 69078) to discuss, with invited scientific experts, preliminary draft materials prepared during the ongoing development of the Pb ISA. The first external review draft ISA for Pb was released on May 6, 2011, and is available at The CASAC Pb Review Panel met at a public meeting on July 20, 2011, to review the draft ISA (76 FR 36120). Subsequently, on December 9, 2011, the CASAC panel provided a consensus letter for their review to the Administrator of the EPA$File/EPA-CASAC-12-002-unsigned.pdf). The second external review draft ISA for Pb will be discussed at a public meeting of the CASAC Pb Review Panel, and public comments received will be provided to the CASAC panel. A future Federal Register notice will inform the public of the exact date and time of that CASAC meeting.

II. How To Submit Technical Comments to the Docket at

Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2011-0051, by one of the following methods:

  • Follow the on-line instructions for submitting comments.
  • Email:
  • Fax: 202-566-1753.
  • Mail: Office of Environmental Information (OEI) Docket (Mail Code: 2822T), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue 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 Avenue 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-ORD-2011-0051. 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, 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 through or email that you consider to be CBI or otherwise protected. The 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 email comment directly to EPA without going through, your email 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

Docket: Documents in the docket are listed in the 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 or in hard copy at the OEI Docket in the EPA Headquarters Docket Center.

Dated: January 26, 2012.

Darrell A. Winner,

Acting Director, National Center for Environmental Assessment.

[FR Doc. 2012-2327 Filed 2-1-12; 8:45 am]