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The Integrated Risk Information System (IRIS) is an environmental assessment program operated by the U.S. Environmental Protection Agency (EPA). Initially, in the 1980s, the program established a database of human health assessments about the impacts of chemicals in the environment. EPA created the database to provide a consistent approach to risk assessment practices across the various environmental laws that the Agency implemented and enforced. The IRIS program is focused on risk assessment, and not risk management (those decision processes involving analysis of regulatory, legal, social and economic considerations related to the risks being studied).[1]

History

The IRIS program was created by the EPA in 1985. Initially, the goal of the program was to foster consistency's in the agency's evaluation of chemical toxicity.[2] The IRIS database was first made publicly available in 1987. In 1996, the EPA implemented a new process for building intra-agency consensus and improving efficiency within the IRIS database. The same year, the EPA introduced the IRIS Toxicological Review, which presented the first agency-wide health assessment document. In March 1997, the IRIS database was uploaded to the internet. In 2004, the IRIS process was changed to add an Office of Management and Budget (OMB)-led interagency review and to place a higher emphasis on outside peer review of IRIS assessments. The IRIS program was once again revised in April 2008; among other things, the newly revised program provided opportunity for research to close data gaps on mission critical chemicals. The following year, the process was changed to streamline a review schedule so that a majority of assessments would be posted to the IRIS database within two years of the start date. In 2013, the EPA announced that it would be making enhancements to the IRIS process in order to improve transparency, efficiency, and the scientific foundation of the agency's assessments.[3] That same year, the program's Toxicological Review documents was restructured to make them more clear, systematic and consistent. In December 2015, the IRIS program released its first ever multi-year agenda, which identified the top chemical assessments the program would focus on in the following years.

IRIS Process for Developing Human Health Assessments

The IRIS process takes about 26 to 39 months to complete, depending on the complexity of the assessment, with the review part of the process taking between 15 to 24 months.[4] The process begins with what the EPA refers to as the "Planning and Scoping" stage.[5] During this stage, risk assessors will consider the scope and possible legal limitations as well as how the information will be used. After the "Planning and Scoping Stage", the EPA has come up with a seven-step risk assessment review program that starts with a draft assessment and ends in publication in IRIS website. The seven-step review process proceeds as follows:

Complete Draft IRIS Assessment

During this stage, the IRIS program conducts literature search and critical study selection, develops evidence tables that summarize the results of these studies. During the drafting stage, the EPA publicly releases assessment protocol which presents the methods for conducting the systematic review.[6] These protocols include literature search strategy and study selection criteria.[7] It is also during this stage that the agency identifies hazards, selects studies for dose-response assessment, and derives toxicity values.

Internal Agency Review

During the internal agency review stage, the IRIS program shares their

The IRIS program was created by the EPA in 1985. Initially, the goal of the program was to foster consistency's in the agency's evaluation of chemical toxicity.[2] The IRIS database was first made publicly available in 1987. In 1996, the EPA implemented a new process for building intra-agency consensus and improving efficiency within the IRIS database. The same year, the EPA introduced the IRIS Toxicological Review, which presented the first agency-wide health assessment document. In March 1997, the IRIS database was uploaded to the internet. In 2004, the IRIS process was changed to add an Office of Management and Budget (OMB)-led interagency review and to place a higher emphasis on outside peer review of IRIS assessments. The IRIS program was once again revised in April 2008; among other things, the newly revised program provided opportunity for research to close data gaps on mission critical chemicals. The following year, the process was changed to streamline a review schedule so that a majority of assessments would be posted to the IRIS database within two years of the start date. In 2013, the EPA announced that it would be making enhancements to the IRIS process in order to improve transparency, efficiency, and the scientific foundation of the agency's assessments.[3] That same year, the program's Toxicological Review documents was restructured to make them more clear, systematic and consistent. In December 2015, the IRIS program released its first ever multi-year agenda, which identified the top chemical assessments the program would focus on in the following years.

IRIS Process for Developing Human Health Assessments

The IRIS process takes about 26 to 39 months to complete, depending on the complexity of the assessment, with the review part of the process taking between 15 to 24 months.[4] The process begins with what the EPA refers to as the "Planning and Scoping" stage.[5] During this stage, risk assessors will consider the scope and possible legal limitations as well as how the information will be used. After the "Planning and Scoping Stage", the EPA has come up with a seven-step risk assessment review program that starts with a draft assessment and ends in publication in IRIS website. The seven-step review process proceeds as follows:

Complete Draft IRIS Assessment

During this stage, the IRIS program conducts literature search and critical study selection, develops evidence tables that summarize the results of these studies. During the drafting stage, the EPA publicly releases assessment protocol which presents the methods for conducting the systematic review.[6] These protocols include literature search strategy and study selection criteria.[7] It is also during this stage that the agency identifies hazards, selects studies for dose-response assessment, and derives toxicity values.

Internal Agency Review

During the internal agency review stage, the IRIS program shares their draft assessment with the EPA's program and regional offices, identifies any scientific issues, and determines external peer review scope and guidelines. This process typically lasts 60 days.The IRIS process takes about 26 to 39 months to complete, depending on the complexity of the assessment, with the review part of the process taking between 15 to 24 months.[4] The process begins with what the EPA refers to as the "Planning and Scoping" stage.[5] During this stage, risk assessors will consider the scope and possible legal limitations as well as how the information will be used. After the "Planning and Scoping Stage", the EPA has come up with a seven-step risk assessment review program that starts with a draft assessment and ends in publication in IRIS website. The seven-step review process proceeds as follows:

Complete Draft IRIS Assessment

During this stage, the IRIS program conducts literature search

During this stage, the IRIS program conducts literature search and critical study selection, develops evidence tables that summarize the results of these studies. During the drafting stage, the EPA publicly releases assessment protocol which presents the methods for conducting the systematic review.[6] These protocols include literature search strategy and study selection criteria.[7] It is also during this stage that the agency identifies hazards, selects studies for dose-response assessment, and derives toxicity values.

Internal Agency Review

During the internal a

During the internal agency review stage, the IRIS program shares their draft assessment with the EPA's program and regional offices, identifies any scientific issues, and determines external peer review scope and guidelines. This process typically lasts 60 days.[8]

Interagency Science Consultation

In

In this step, the IRIS program publicly releases its draft assessment on its website as part of an external review process, after which a meeting is held to allow for peer review charge and scientific questions. After this, IRIS may revise their assessment draft and submit it to an external peer review panel organized by a contractor or by the EPA's Science Advisory Board.

Revising Assessment

Here, the IRIS program evaluat

Here, the IRIS program evaluates the recommendations provided by the peer review panel and all public comments. During this step, IRIS also prepares a written response-to-comment document. After revising its initial assessment, IRIS develops a disposition of peer review and public comments and provides them as an appendix to its final assessment.

Final Agency Review/Interagency Science Discussion

During this stage, the IRIS program completes its assessment and posts the final product on the IRIS website along with related material, including the Toxicological Revi

During this stage, the IRIS program completes its assessment and posts the final product on the IRIS website along with related material, including the Toxicological Review document, IRIS summary and appendices.

Relationship with Environmental Impact Assessment