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Draft Plan for Development of the Integrated Science Assessment for Nitrogen Oxides-Health Criteria

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Environmental Protection Agency (EPA).


Notice of public comment period.


The U.S. EPA is announcing the availability of the “Draft Plan for Development of the Integrated Science Assessment for Nitrogen Oxides—Health Criteria.” The draft 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 primary (health-based) national ambient air quality standards (NAAQS) for nitrogen dioxide (NO2). The purpose of this draft document is to communicate the plan for the development of the Integrated Science Assessment (ISA) for the health effects of nitrogen oxides (NOX), which will provide a comprehensive assessment of the current scientific literature pertaining to known and anticipated effects on public health associated with the NOX in the ambient air.

EPA is releasing this draft document to seek consultation by the Clean Air Scientific Advisory Committee (CASAC) and the public (meeting date and time 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 draft plan for development of the NOX ISA.


The public comment period begins, May 3, 2013, and ends May 31, 2013. Comments must be received on or before May 31, 2013.


The “Draft Plan for Development of the Integrated Science Assessment for Nitrogen Oxides—Health Criteria” will be available primarily via the Internet on the NCEA home page under the Recent Additions and Publications menus at​ncea or in the public docket at (Docket ID: EPA-HQ-ORD-2013-0232). 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, “Draft Plan for Development of the Integrated Science Assessment for Nitrogen Oxides—Health Criteria” to facilitate processing of your request.

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For technical information, contact Dr. Molini Patel, NCEA; telephone: 919-541-1492; facsimile: 919-541-1818; or email:

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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 [the] pollutant in the ambient air . . . .” Under section 109 of the Act, EPA is then to establish 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 or welfare. EPA is also to revise the NAAQS, if appropriate, based on the revised air quality criteria.

NO2 is one of six criteria pollutants for which EPA has established NAAQS. Periodically, EPA reviews the scientific basis for these standards by preparing an ISA (formerly called an Air Quality Criteria Document). The ISA, in conjunction with additional technical and policy assessments, provide the scientific basis for EPA decisions on the adequacy of the current NAAQS and the appropriateness of possible alternative standards. The CASAC, an independent science 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 10, 2012 (77 FR 7149), EPA formally initiated its current review of the air quality criteria for the health effects of NOX and the primary (health-based) NO2 NAAQS, requesting the submission of recent scientific information on specified topics. EPA held a workshop February 29 to March 1, 2013, to discuss with invited scientific experts, key science and policy issues relevant to the review of the health effects of NOX (77 FR 7149). NCEA has prepared a draft plan for development of the ISA for the health effects of NOX, which communicates the scope, organization, methodology, and key policy-relevant issues for the ISA. EPA is planning to release the first external review draft of the health effects ISA for NOX for review by CASAC and the public later on in 2013.

Development of the ISA is one phase of the NAAQS review, and a draft Integrated Review Plan (IRP) is being developed that will characterize all of the phases of the review of the primary NAAQS for NO2, including the schedule for the entire review, the process for conducting the various phases of the review, and the key policy-relevant science issues that will guide the review. The draft IRP will be released for review by CASAC and the public later on in 2013 and after consideration of CASAC and public comments, a final IRP will be issued in early 2014. The IRP will incorporate a revised plan for ISA development after consideration of CASAC and public comments.

II. How To Submit Technical Comments to the Docket at

Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2013-0232 by one of the following methods:

  • Follow the on-line instructions for submitting comments.
  • Email:
  • Fax: 202-566-9744.
  • Mail: Office of Environmental Information (OEI) Docket (Mail Code: 28221T), 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, EPA West Building, Room 3334, 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 Start Printed Page 26027Public 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-2013-0232. 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​epahome/​dockets.htm.

Docket: Documents in the docket are listed in the 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.

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Dated: April 18, 2013.

Debra B. Walsh,

Acting Director, National Center for Environmental Assessment.

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[FR Doc. 2013-10430 Filed 5-2-13; 8:45 am]