IRIS Toxicological Review of Ammonia Noncancer Inhalation (Interagency Science Discussion Draft)

Abstract

In September 2016, EPA finalized the IRIS assessment of Ammonia (Noncancer Inhalation). The Toxicological Review was reviewed internally by EPA and by other federal agencies and White House Offices before public release in June 2016. Consistent with the May 2009 IRIS assessment development process, all written comments on IRIS assessments submitted by other federal agencies and White House Offices are made publicly available. Accordingly, interagency comments and the interagency science discussion materials provided to other agencies, including interagency review drafts of the IRIS Toxicological Review of Ammonia (Noncancer Inhalation) are posted on this site.

Note: No major science comments were received on the Interagency Science Discussion Draft.
Ammonia occurs naturally in air, soil, and water. Ammonia is also produced by humans and other animals as part of normal biological processes. Ammonia is used as an agricultural fertilizer and in many cleaning products. Exposure to ammonia occurs primarily through breathing air containing ammonia gas, and may also occur via diet, drinking water, or direct skin contact. Concentrations of ammonia measured in ambient outdoor air range from 0.28‒15 μg/m³ and in indoor air from 0.09–166 μg/m³.

Health effects of inhaled ammonia observed at levels exceeding naturally-occurring concentrations are generally limited to the respiratory tract, the site of direct contact with ammonia. Short-term inhalation exposure to high levels of ammonia in humans can cause irritation and serious burns in the mouth, lungs, and eyes. Chronic exposure to airborne ammonia can increase the risk of respiratory irritation, cough, wheezing, tightness in the chest, and reduction in the normal function of the lung in humans. Studies in experimental animals similarly indicate that breathing ammonia at sufficiently high concentrations can result in effects on the respiratory system. Animal studies also suggest that exposure to high levels of ammonia in air may adversely affect other organs, such as the liver, kidney, and spleen.

Impact/Purpose

EPA is undertaking an Integrated Risk Information System (IRIS) health assessment for ammonia. IRIS is an EPA database containing Agency scientific positions on potential adverse human health effects that may result from chronic (or lifetime) exposure to chemicals in the environment. IRIS contains chemical-specific summaries of qualitative and quantitative health information in support of two steps of the risk assessment paradigm, i.e., hazard identification and dose-response evaluation. IRIS assessments are used in combination with specific situational exposure assessment information to evaluate potential public health risk associated with environmental contaminants.

Status

The ammonia (inhalation) assessment has been loaded into the IRIS Web site and database.

Citation

U.S. EPA. IRIS Toxicological Review of Ammonia Noncancer Inhalation (Interagency Science Discussion Draft). U.S. Environmental Protection Agency, Washington, DC, EPA/635/R-16/098, 2016.

Date	Description
01- May 1991	The RfC for ammonia was posted to the IRIS database.
06- Feb 2012	Revised draft assessment was submitted for Agency review and interagency science consultation.
08- Jun 2012	EPA released the external review draft of the ammonia assessment for public review and comment. Additionally, the interagency science consultation draft, comments from reviewers, and EPA's responses to selected major interagency comments were also released.  [Federal Register Notice Jun 8, 2012]
09- Aug 2013	EPA's Science Advisory Board (SAB) announced a request for nominations for experts to augment the SAB Chemical Assessment Advisory Committee (CAAC) for the review of the EPA's draft IRIS assessment for ammonia [Federal Register Notice Aug 28, 2013] (3pp., 210Kb, about PDF), and made available the revised external review draft assessment and draft charge to peer reviewers.
18- Jul 2014	EPA's SAB CAAC convenes to discuss the external review draft of the IRIS assessment.
19- Aug 2015	EPA's IRIS Program receives final external peer review report from the SAB. To address SAB recommendations related to the assessment of ingested ammonia and to allow completion of the assessment of inhaled ammonia, the scope of the assessment was limited to the noncancer effects of ammonia via inhalation exposure. An assessment of ammonia (oral) was added to the IRIS Multi-Year Agenda in 2015.
20- Jun 2016	EPA submits the revised draft for final Agency Review and Interagency Science Discussion.
21- Sep 2016	EPA posts the final IRIS assessment of Ammonia—Noncancer Inhalation to the IRIS database. EPA also released the Interagency Science Discussion Draft, Comments and EPA's Response to Comments.

This download(s) is distributed solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. It has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency determination or policy.

• IRIS Toxicological Review of Ammonia -- Noncancer Inhalation (Interagency Science Discussion Draft) (PDF)  (95  pp, 1.4 MB, about PDF)
• IRIS Toxicological Review of Ammonia -- Noncancer Inhalation (Interagency Science Discussion Draft) -- Supplemental Information (PDF)  (131  pp, 1.7 MB, about PDF)
• 1. OMB Comments on Ammonia (PDF)  (1  pp, 198.2 KB, about PDF)

Related Link(s)

• IRIS Toxicological Review of Ammonia (External Review Draft)
• IRIS Toxicological Review of Ammonia (Interagency Science Consultation Draft)
• IRIS Toxicological Review of Ammonia (Revised External Review Draft)
• IRIS Toxicological Review of Ammonia Noncancer Inhalation (Final Report)