Strengthening IRIS: Cultivating Broad Scientific Input

By Louis D’Amico, Ph.D.

IRIS graphic identifierAs a scientist in EPA’s Integrated Risk Information System (IRIS) Program, I am routinely faced with the task of evaluating evidence to determine if a chemical may cause a toxic effect. Developing chemical health assessments involves evaluating complex, sometimes controversial scientific issues that may lead to differing opinions about the interpretation of the data. That’s why the IRIS Program has always relied on engagement with the larger scientific community, through public comment and peer review, to support the development of our assessments.

Last year, EPA announced several enhancements to improve the productivity and quality of IRIS assessments, including holding regular bimonthly public science meetings. This gives the scientists who develop IRIS assessments the opportunity to engage with the public and the scientific community on topics throughout the development of an assessment. However, we want to ensure that we are hearing scientific perspectives from a diversity of experts in open, public, and transparent ways during assessment development. As the National Research Council (NRC) 2014 report on the IRIS Process indicated, some stakeholders may not have the staff, organizational, or other resources to provide comments or detailed scientific input. The NRC report recommended that EPA continue with additional efforts to ensure that the full breadth of perspectives are made available to the Agency when discussing the IRIS process and specific IRIS assessments.

IRIS meeting in a large conference room

EPA holds regular public IRIS meetings.

To broaden the input the IRIS Program receives at our bimonthly meetings, EPA has asked the National Research Council to identify additional scientific experts to join in our discussions. The public will continue to have the same opportunity to participate as discussants that they had before. If you want to participate as a discussant, you simply need to indicate that when registering for the meeting. Experts identified by the National Research Council, reviewed for conflict of interest and bias, will participate as discussants in their own capacity to contribute intellectual leadership to discussions on critical scientific issues. The final determination of who serves as an expert participant is made independently by the National Research Council.

Bringing more scientific minds to the table will only strengthen our assessments by encouraging a more robust discussion. Ultimately it’s not the number of participants expressing an opinion, but the scientific validity of their positions. Hearing multiple perspectives on how to interpret science issues will help my colleagues and I better address and incorporate those issues and perspectives into our assessments prior to expert peer review. Moving forward, I am looking forward to future discussions on the science at our bimonthly meetings and encourage you to join the continuing discussion on the evolution of the IRIS Program.

About the Author: Louis D’Amico, P.h.D. is the Acting Communications Director for the National Center for Environmental Assessment. He joined EPA five years ago and has a doctorate in Biology.

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Improving IRIS: Please Join the Conversation

By Kacee Deener

IRIS graphic identifier

Over the past few years, EPA has embraced a major new effort to enhance its Integrated Risk Information System (IRIS) Program to improve the scientific foundation of assessments, increase transparency, and improve productivity. IRIS is a human health assessment program that evaluates information on health effects that may result from exposure to environmental contaminants. Information from IRIS is used by EPA and others to support decisions to protect human health.

We think we’ve made terrific progress so far, and we were thrilled that the National Academies’ National Research Council (NRC) agrees. They spent the past two years reviewing IRIS, and in May 2014, they issued a report highlighting our progress and offering recommendations on keeping the progress moving forward (Assistant Administrator Lek Kadeli recently wrote about this on EPA Connect, the Agency’s leadership blog).

In their report, the NRC commended EPA for its substantive new approaches, continuing commitment to improving the process, and successes to date. They noted that the IRIS Program has moved forward steadily in planning for and implementing changes in each element of the assessment process. They also provided several recommendations which they said should be seen as building on the progress we’ve already made.

We are happy to announce that we are taking additional steps to improve the IRIS Program. In October, we will hold a public workshop to discuss specific recommendations from the NRC’s report, which fall under the three broad topics below. We invite you to provide early input by commenting on this blog post, which is the first in a new IRIS blog series geared toward generating online scientific discussion about issues relevant to the IRIS Program. We plan to use blog posts like this more in the future to get your input.

  • Topic 1 – Refining systematic review methodology, including methods to evaluate risk of bias. The NRC stated that EPA should continue to document and standardize its process for evaluating evidence and recommended EPA develop tools for assessing risk of bias in human, animal, and mechanistic studies that are used as primary data sources. The NRC noted the limitations of available approaches for use with observational (nonrandomized) studies, and advocated exploration of differences in applying methods for evaluating epidemiological studies to controlled experimental in vivo and in vitro studies. They noted that these approaches will depend on the complexity and extent of data on a chemical and the resources available to EPA, and that additional methodological work might be needed to develop empirically-supported evaluation criteria for animal or mechanistic studies.
  • Topic 2 – Advancing methodology to systematically evaluate and integrate evidence streams. The NRC stated that EPA should continue to improve its evidence-integration process incrementally, and to enhance its transparency. The committee provided several alternatives for organizing evidence of hazard potential and recommended that the IRIS Program should either continue with the guided-expert-judgment process for evaluating evidence, but make its application more transparent, or adopt a structured approach with rating recommendations. The committee also encouraged the IRIS Program to simultaneously expand its ability to perform quantitative modeling, specifically using Bayesian methods, to inform hazard identification.
  • Topic 3 – Combining quantitative results from multiple studies, presenting appropriate quantitative toxicity information, and advancing analyses and communication of uncertainty. The committee encouraged the IRIS Program to continue its shift towards the use of multiple studies for dose-response assessment, but with increased attention to judging the relative merits of mechanistic, animal and epidemiologic studies, with an ultimate goal of developing formal methods for combining studies and deriving toxicity values in a transparent and replicable manner. The NRC stated that it is critical to consider systematic approaches to synthesizing and integrating the derivation of a range of toxicity values in light of variability and uncertainty. Integral to this latter goal is the NRC recommendation to develop methods to systematically conduct uncertainty analyses and to appropriately communicate uncertainty to the users of IRIS assessments.

We’re interested in hearing your thoughts about the NRC recommendations above. For example, do you have ideas about how we should move forward to address the recommendations in these topic areas? Do you have scientific suggestions for the IRIS Program to consider related to these topics? Do you have suggestions for who we should ask to speak at the workshop? Please add your thoughts, ideas, and suggestions in the comments below and join the conversation!

About the Author: Kacee Deener is the Communications Director in EPA’s National Center for Environmental Assessment.  She joined EPA 13 years ago and has a Masters degree in Public Health.

Editor's Note: The views expressed here are intended to explain EPA policy. They do not change anyone's rights or obligations. You may share this post. However, please do not change the title or the content, or remove EPA’s identity as the author. If you do make substantive changes, please do not attribute the edited title or content to EPA or the author.

EPA's official web site is www.epa.gov. Some links on this page may redirect users from the EPA website to specific content on a non-EPA, third-party site. In doing so, EPA is directing you only to the specific content referenced at the time of publication, not to any other content that may appear on the same webpage or elsewhere on the third-party site, or be added at a later date.

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National Academies’ Report Shows that EPA has Strengthened IRIS Program

Reposted from EPA Connect, the official blog of EPA’s leadership.

By Lek Kadeli

Portrait of Lek KadeliOne of the best aspects of my job is working with some of the most dedicated human health and environmental scientists in the business. On a daily basis, I have a behind-the-scenes view of the innovation and problem solving that is meeting the nation’s most pressing environmental challenges and advancing a more sustainable future for us and our children. It’s inspiring to see that progress unfold, and I feel fortunate to have a front row seat. But what’s even more gratifying is when leaders in the scientific community world take notice, too.

That’s exactly what happened today when we received positive news about progress we’ve made to enhance our Integrated Risk Information System, or “IRIS” program. IRIS provides health effects information about environmental contaminants such as dioxin and tetrachloroethylene. The program received some well-deserved kudos from the National Academies’ National Research Council (NRC). I’m really proud of the whole IRIS team! This is an example of EPA science at its best, and how our researchers rise to meet challenges.

Read the rest of the post.

Editor's Note: The views expressed here are intended to explain EPA policy. They do not change anyone's rights or obligations. You may share this post. However, please do not change the title or the content, or remove EPA’s identity as the author. If you do make substantive changes, please do not attribute the edited title or content to EPA or the author.

EPA's official web site is www.epa.gov. Some links on this page may redirect users from the EPA website to specific content on a non-EPA, third-party site. In doing so, EPA is directing you only to the specific content referenced at the time of publication, not to any other content that may appear on the same webpage or elsewhere on the third-party site, or be added at a later date.

EPA is providing this link for informational purposes only. EPA cannot attest to the accuracy of non-EPA information provided by any third-party sites or any other linked site. EPA does not endorse any non-government websites, companies, internet applications or any policies or information expressed therein.