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Draft Integrated Science Assessment for Oxides of Nitrogen-Health Criteria

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Environmental Protection Agency.


Notice of Public Comment Period.


The Environmental Protection Agency (EPA) is announcing a 60-day public comment period for the draft document titled, “Second External Review Draft Integrated Science Assessment for Oxides of Nitrogen—Health Criteria” (EPA/600/R-13/005). The draft document was prepared by the National Center for Environmental Assessment (NCEA) within EPA's Office of Research and Development (ORD) as part of the review of the primary (health-based) National Ambient Air Quality Standards (NAAQS) for nitrogen dioxide (NO2). The Integrated Science Assessment (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. EPA is developing a separate ISA and NAAQS review for the secondary (welfare-based) NAAQS for NO2, in conjunction with a review of the secondary NAAQS for sulfur dioxide (78 FR 53452).

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). This draft document is not final as described in EPA's information quality guidelines, and it does not represent and should not be construed to represent Agency policy or views. EPA will consider any public comments submitted in response to this notice when revising the document.


The 60-day public comment period begins January 30, 2015, and ends March 31, 2015. Comments must be received on or before March 31, 2015.


The “Second External Review Draft Integrated Science Assessment for Oxides of Nitrogen—Health Criteria” will be available primarily via the Internet on NCEA's home page under the Recent Additions and Publications menus at​ncea or the public docket at, Docket ID: EPA-HQ-ORD-2013-0232. A limited number of CD-ROM copies will be available. Contact Ms. Marieka Boyd by phone: 919-541-0031; fax: 919-541-5078; or email: to request a CD-ROM, and please provide your name, your mailing address, and the document title, “Second External Review Draft Integrated Science Assessment for Oxides of Nitrogen—Health Criteria” to facilitate processing of your request.

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For information on the public comment period, contact the ORD Docket at EPA's Headquarters Docket Center; telephone: 202-566-1752; facsimile: 202-566-9744; or email:

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 that, 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, the 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 required to review and, if appropriate, revise the NAAQS, based on the revised air quality criteria (for more information on the NAAQS review process, see​ttn/​naaqs/​review.html).

The oxides of nitrogen are 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, provides 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 oxides of nitrogen and the primary (health-based) NO2 NAAQS, requesting the submission of recent scientific information on specified topics. EPA held a workshop on February 29 to March 1, 2012, to gather input from scientific experts, both internal and external to EPA, as well as from the public regarding key science and policy issues that will frame the review of the health effects of the oxides of nitrogen and the primary NO2 NAAQS (77 FR 7149, February 10, 2012).

The discussions at this workshop guided the development of EPA's “Draft Plan for Development of the Integrated Science Assessment for Nitrogen Oxides—Health Criteria,” a draft “Integrated Review Plan for the Primary NAAQS for Nitrogen Dioxide” (EPA-452/R-14-003) (IRP), and initial draft materials for the development of the ISA. The draft plan for the development of the ISA was made available for public comment on May 3, 2013 (78 FR 26026), and was discussed by CASAC via a publicly accessible teleconference consultation on June 5, 2013 (78 FR 27234, May 9, 2013). On June 11, 2013, EPA held a workshop to discuss, with invited scientific experts, initial draft materials prepared for the development of the ISA (78 FR 27374, May 10, 2013). The draft IRP was made available in February 2014 for public comment and CASAC review (79 FR 7184, February 6, 2014). The IRP was reviewed by CASAC at a public meeting on March 12, 2014 (79 FR 8701, February 13, 2014). The final IRP was released in June 2014 (79 FR 36801, June 30, 2014), and is available at:​ttn/​naaqs/​standards/​nox/​s_​nox_​2012_​pd.html.

Comments on the draft plan for the ISA and discussion at the June 11, 2013, workshop guided development of the “First External Review Draft Integrated Science Assessment for Oxides of Nitrogen—Health Criteria,” which was released on November 22, 2013 (78 FR 70040), and is available at:​ncea/​isa/​recordisplay.cfm?​deid=​259167. The CASAC Start Printed Page 5111review panel for the oxides of nitrogen met at a public meeting on March 12-13, 2014, to review the draft ISA along with the draft IRP (79 FR 8701, February 13, 2014). Subsequently, on June 10, 2014, the CASAC panel provided a consensus letter for their review to the Administrator of EPA (​sab/​sabproduct.nsf/​264cb1227d55e02c85257402007446a4/​15E4619D3CD3409A85257CF30069387D/​$File/​EPA-CASAC-14-002+​unsigned.pdf). The second external review draft ISA was developed with consideration of comments received from CASAC and the public on the first external review draft ISA and includes consideration of scientific studies published through August 2014. The second external review draft ISA will be discussed by CASAC at a public meeting. In addition to the public comment period announced in this notice, the public will have an opportunity to submit written and/or oral comments related to the second external review draft ISA to CASAC. A separate Federal Register notice will inform the public of the exact date and time of that CASAC meeting and of the procedures for public participation.

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: U.S. Environmental Protection Agency, EPA's Docket Center (ORD Docket), Mail Code: 28221T, 1200 Pennsylvania Avenue NW., Washington, DC 20460. The phone number is 202-566-1752.
  • Hand Delivery: The ORD Docket is located in EPA's Headquarters Docket Center, EPA West Building, Room 3334, 1301 Constitution Avenue NW., Washington, DC. EPA's 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-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 EPA's 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 ORD Docket in EPA's Headquarters Docket Center.

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Dated: January 20, 2015.

Gina Perovich,

Acting Deputy Director, National Center for Environmental Assessment.

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[FR Doc. 2015-01606 Filed 1-29-15; 8:45 am]