2018-07746. Availability of the IRIS Assessment Plan for Ammonia and Ammonium Salts: Noncancer Assessment for Oral Exposure

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice of public comment period.

SUMMARY:

The Environmental Protection Agency (EPA) is announcing a 30-day public comment period associated with release of the draft IRIS Assessment Plan for ammonia and ammonium salts. This document communicates information on the scoping needs identified by EPA program and regional offices and the IRIS Program's initial problem formulation activities. Specifically, the assessment plan outlines the objectives for each assessment and the type of evidence considered most pertinent to address the scoping needs. EPA is releasing this draft IRIS Assessment Plan for public comment at least 30 days in advance of a public science webinar planned on May 23, 2018.

DATES:

The 30-day public comment period begins April 16, 2018, and ends May 16, 2018.

ADDRESSES:

The IRIS Assessment Plan for Ammonia and Ammonium Salts, will be available via the internet on IRIS' website at https://cfpub.epa.gov/​ncea/​iris2/​chemicalLanding.cfm?​substance_​nmbr=​422 and in the public docket at http://www.regulations.gov,, Docket ID: EPA-HQ-ORD-2018-0132.

FOR FURTHER INFORMATION CONTACT:

For information on the public comment period, contact the ORD Docket at the EPA Headquarters Docket Center; telephone: [phone]; facsimile: 202-566-9744; or email: [e-mail].

For technical information on the draft IRIS Assessment Plan for ammonia and ammonium salts, contact Dr. James Avery, NCEA; telephone: [phone]; or email: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background Information on IRIS Assessment Plans

EPA's IRIS Program is a human health assessment program that evaluates quantitative and qualitative risk information on effects that may result from exposure to chemicals found in the environment. Through the IRIS Program, EPA provides the highest quality science-based human health assessments to support the Agency's regulatory activities and decisions to protect public health. As part of scoping and initial problem formulation activities prior to the development of a draft assessment, the IRIS Program carries out a broad, preliminary literature survey to assist in identifying health effects that have been studied in relation to the chemical or substance of interest, as well as science issues that may need to be considered when evaluating toxicity. This information, in conjunction with scoping needs identified by EPA program and regional offices, is used to inform the development of an IRIS Assessment Plan (IAP).

The IAP communicates the plan for developing each individual chemical assessment to the public and includes summary information on the IRIS Program's scoping and initial problem formulation, objectives and specific aims for the assessment, and a PECO (Populations, Exposures, Comparators, and Outcomes) for the systematic review. The PECO provides the framework for developing literature search strategies and inclusion/exclusion criteria, particularly with respect to evidence stream (i.e., human, animal, mechanistic), exposure measures and outcome measures. The IAP serves to inform the subsequent development of chemical-specific systematic review protocols, which will be made publicly available.

II. Public Webinar

In order to allow for public input, EPA is convening a public webinar to discuss the draft IRIS Assessment Plan for ammonia and ammonium salts on May 23, 2018. Specific teleconference and webinar information regarding this public meeting will be provided through the IRIS website (https://www.epa.gov/​iris) and via EPA's Human Health Risk Assessment (HHRA) and IRIS listservs. To register for the HHRA or IRIS listserv, visit the IRIS website (https://www.epa.gov/​iris) or visit https://www.epa.gov/​iris/​forms/​staying-connected-integrated-risk-information-system#connect.

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

Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2018-0132 for ammonia, by one of the following methods:

• www.regulations.gov: Follow the on-line instructions for submitting comments.
• Email: [e-mail].
• Fax: [phone].
• Mail: U.S. Environmental Protection Agency, EPA 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 the EPA Headquarters Docket Center, EPA West Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC 20229.

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. 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 number EPA-HQ-ORD-2018-0132 for ammonia and ammonium salts. 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 www.regulations.gov,, including any personal information provided, unless a comment includes information claimed to be Confidential Business Information (CBI) or other information for which disclosure is restricted by statute. Do not submit information through www.regulations.gov or email that you consider to be CBI or otherwise protected. The www.regulations.gov website 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 www.regulations.gov,, 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 www.epa.gov/​epahome/​dockets.htm.

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 www.regulations.gov or in hard copy at the ORD Docket in the EPA Headquarters Docket Center.

Dated: April 5, 2018.

Tina Bahadori,

Director, National Center for Environmental Assessment.