www.epa.gov/research
                           science    in  ACTION
                           INNOVATIVE RESEARCH  FOR A SUSTAINABLE FUTURE
                             Strengthening the IRIS Process - 2011
      What is IRIS?
      IRIS, or EPA's Integrated Risk Information System,
      provides information on potential human health risks
      from long term exposure to over 540 chemicals present
      in air, water, or on land. IRIS assessments are critical to
      the agency's programs and regulations, as they provide a
      scientific foundation for many of EPA's decisions. IRIS
      assessments are also utilized by many local, state, and
      international governments to assess health risks posed by
      exposure to various environmental contaminants.


      Background	
      In May 2009, EPA implemented a new IRIS process to
      make it more responsive to the needs of the Agency and
      its government partners. In part, the changes were in
      response to a 2008 report by the Government
      Accountability Office (GAO) that found that the IRIS
      database was at serious risk of becoming obsolete
      because EPA had not been able to routinely complete
      timely, credible assessments or decrease its backlog of
      ongoing assessments—a total of 4 were completed in
      fiscal years 2006 and 2007. The aim of the new process
      was to ensure the highest level of scientific quality,
      integrity, transparency, and timeliness.
      Changes to IRIS Process under Administrator Lisa P.
      Jackson	
      The May 2009 revised process included the following
      key features:
      •   EPA manages the IRIS program and has final
         responsibility for the content of all IRIS assessments
      •   The assessment development time was shortened to
         23 months—a reduction of more than half the
         estimated time for an assessment to be developed
         under the previous process
      •   The number of steps in the assessment development
         process was reduced from 14 to 7
      •   Other federal agencies and White House offices
         have the opportunity to provide scientific input at
         two points in the assessment development process,
         and their comments are made publicly available
      •   The assessment development process includes the
         opportunity for public comment and relies on an
         open, rigorous and independent external peer review

             U.S. Environmental Protection Agency
             Office of Research and Development
•   A public listening session is offered for each
    chemical assessment
•   Changes in EPA's scientific judgments during the
    process are clearly documented and explained

Further Changes to IRIS since May 2009:	
•   EPA's program and regional offices now have an
    extended role in nominating and prioritizing
    chemicals for assessment—ensuring the IRIS
    program is focused on the highest Agency needs.
•   IRIS program managers regularly meet with EPA
    programs and regions to discuss individual IRIS
    assessments and the IRIS process.
•   EPA has created an IRIS logistics team to help
    streamline  the assessment development process
•   EPA has developed the Health and Environmental
    Research Online Database - or HERO - which
    makes the scientific studies selected and used by the
    Agency to  develop assessments available to the
    public.
•   EPA has developed Memoranda of Understanding
    with the California Environmental Protection
    Agency's Office of Environmental Health Hazard
    Assessment and the Agency for Toxic Substances
    and Disease Registry, to cooperate in the
    development of health assessments to encourage
    data sharing and avoids duplication of effort.


Results of Improved IRIS since 2009	
Since the new process was instituted in 2009, EPA has
completed 16 assessments, more than the number of
assessments that were completed in the previous four
years. The IRIS backlog has been significantly reduced
and the Agency has 70 assessments in the IRIS process
at various  stages.
InFY 2010, EPA completed 10 IRIS assessments and
released nine for public comment and external peer
review, seven of which were major assessments. In FY
2011, EPA anticipates  releasing  13 completed
assessments, including a number of major assessments
such as trichloroethylene, tetrachloroethylene, arsenic
and ethylene oxide. In addition, EPA has a number of
assessments that will be released for external peer
review, including PCBs and Libby  amphibole asbestos.

-------
2011 National Academy of Sciences (NAS) Report on
EPA's IRIS Formaldehyde Assessment
In April, 2011, the NAS released its "Review of the
Environmental Protection Agency's Draft IRIS
Assessment of Formaldehyde." In addition to offering
comments about EPA's draft formaldehyde assessment,
the NAS included comments and recommendations to
improve IRIS documents.  The NAS focused their
comments on the development of draft IRIS assessments
and did not recommend changes to the overall IRIS
process. EPA welcomes these recommendations and is
taking the following actions to implement them:
1.   NAS recommended that EPA edit documents to
    reduce the text volume and address redundancies
    and inconsistencies.
    In response, EPA is editing our assessment
    documents to substantially reduce the volume of text
    and eliminate redundancies and inconsistencies;
    building on existing IRIS guidelines and process to
    enhance the clarity and transparency of data
    evaluation and the presentation of findings and
    conclusions; consolidating related discussions to
    eliminate redundancies; increasing the use of tables
    and figures to improve communication of
    information; and providing reference information on
    the IRIS website for all studies considered.

2.   NAS recommended that EPA include a fuller
    discussion of methods and develop concise
    statements of the criteria used to exclude, include
    and advance studies for hazard evaluation and
    derivation oftoxicity values.
    In response, EPA is providing a fuller discussion of
    the methods used in its assessments, along with
    concise statements of the criteria used to exclude,
    include, and focus on the highest quality studies for
    hazard assessment and for derivation oftoxicity
    values; working towards replacing text descriptions
    of the studies with standardized evidence tables that
    provide the methods and results of each study for all
    health outcomes; and including text that will
    accompany evidence tables to present the criteria
    used to include or exclude studies.

3.   NAS recommended that EPA provide a clearer
    articulation of the rationale and criteria for
    screening studies.
    In response, EPA is enhancing the sequential
    approach for progressively focusing on the most
    pertinent information, including: searching the
    literature, identifying the pertinent studies, and
    evaluating study characteristics; evaluating the
    overall weight of evidence for each health outcome;
    identifying plausible approaches for developing
    toxicity values; selecting the most pertinent data and
    developing toxicity values for each health hazard;
    and, portraying toxicity information graphically.

4.   NAS recommended that EPA use uniform
    approaches to thoroughly evaluate the strengths and
    weaknesses of critical studies, summarize findings in
    tables, and clearly articulate the rationale for the
    studies used to calculate toxicity values.
    In response, EPA is streamlining IRIS assessment
    documents and more fully documenting the
    approach for assembling and evaluating the range of
    scientific data. As the NAS report indicated, EPA
    has already made similar changes to how the
    scientific evidence is presented on the criteria air
    pollutants in its Integrated Science Assessments.
    EPA is also implementing a more uniform approach
    to the evaluation of the strengths and weaknesses of
    critical studies to increase the clarity of the rationale
    for selecting the studies used to calculate toxicity
    values. Lastly, EPA is increasing the use of evidence
    tables that summarize the factual details  of pertinent
    studies for each health hazard and developing
    standardized language to describe study strengths
    and limitations.

5.   NAS recommended that EPA provide descriptions to
    indicate various determinants of weight of evidence
    to promote understanding of what elements were
    emphasized in synthesizing the evidence.
    In response, EPA is augmenting our current analysis
    of data to indicate which criteria were most
    influential in evaluating the weight of evidence.

    In addition, EPA is working closely with the
    Agency's Science Advisory Board to develop a
    dedicated advisory committee that will exclusively
    focus on the quality, transparency and scientific
    rigor of IRIS assessments and guide EPA's response
    to the NAS recommendations. A hallmark of the
    new IRIS process is strengthened independent peer
    review of the IRIS program.

    EPA will also create a new peer consultation step
    early in the development of major IRIS assessments
    to enhance the input of the scientific community as
    assessments are designed.


In making these changes, EPA's goal is to continually
improve its IRIS assessments without taking  any
assessment backwards to earlier steps of the process.
Therefore, these recommendations will be implemented
in a tiered approach, making the most extensive changes
to documents that are in the earlier stages of the
assessment development process.
        U.S. Environmental Protection Agency
        Office of Research and Development

-------