Integrated Risk Information System

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.

Editor's Note: The opinions expressed here are those of the author. They do not reflect EPA policy, endorsement, or action.

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A Message to IRIS Program Stakeholders: We Want to Hear From You!

By Kacee Deener

IRIS graphic identifierIn July 2013, EPA announced enhancements to our Integrated Risk Information System (IRIS) program to improve the scientific foundation of assessments, increase transparency, and improve productivity. Stakeholder engagement is an essential part of the enhancements, and since announcing them, we have held bimonthly public meetings to discuss scientific issues related to preliminary assessment materials and draft IRIS assessments. We announce these meetings well in advance on the IRIS website, and we publicly release any relevant materials about two months before the meeting is held. We also identify specific scientific issues related to the chemicals we are assessing.

Did you know that anyone can participate in these meetings? You can register to participate as a discussant on a specific scientific issue identified by EPA, or you can identify one of your own. Likewise, you can participate in the meetings more generally (i.e., not sign up for a specific scientific topic, but participate during discussion and open forum sessions). We don’t put together an invited panel for these meetings, and the agenda reflects those individuals who requested to participate in the scientific discussions.

IRIS meeting in a large conference room

EPA holds a public IRIS meeting.

We realize that you can never do too much where communication is concerned, so we use a variety of ways to publicize the meetings. They are announced on the IRIS website and through the IRIS Listserv and Human Health Risk Assessment research program bulletins, which reach more than 7,000 people combined. If you’re not on these lists, please sign up! We also use various social media platforms, including Twitter (follow IRIS and other EPA research on Twitter @EPAresearch).

We know that getting different perspectives on scientific issues is important, and we are exploring additional ways to reach out to scientists and other individuals who might be interested in participating in our meetings and contributing to the IRIS process.

We recognize that not all of our stakeholders have the resources to travel to a meeting. Because of that, for the past year and a half, every IRIS public meeting has also been available by webinar. We’ve also made some recent changes so that webinar participants can more fully engage in our meetings, including using telephone connections that allow webinar participants to actively participate in discussions.

EPA’s IRIS Program works on behalf of the American people, and anyone is welcome to add their voice to the conversation. We welcome your ideas about how to expand public access to and engagement in IRIS activities. We also welcome your input about how to obtain additional perspectives on the complex scientific issues that are discussed at IRIS bimonthly public science meetings. Join the conversation today by commenting on this blog post or sending us your ideas through the IRIS general comments docket.

As always, we want to hear from you!

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 opinions expressed here are those of the author. They do not reflect EPA policy, endorsement, or action.

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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.

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Editor's Note: The opinions expressed here are those of the author. They do not reflect EPA policy, endorsement, or action.

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National Academies’ report shows that EPA has strengthened IRIS program

By Lek Kadeli

One 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.

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Editor's Note: The views expressed here are intended to explain EPA policy. They do not change anyone's rights or obligations.

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Human Health Risk Assessment—What it’s all about

Three images arranged horizontally: grade school students in classroom; girl with arms raised; bicyclists at sunrise

By Kacee Deener 

Scientists need to be able to describe—in a way everyone can understand—what we do and why it’s important.  That’s one reason I’ve decided that I need to strengthen my “elevator speech” about what I do (human health risk assessment).  I will be writing blog posts over the next several weeks trying to explain human health risk assessment in plain language.

For this first post, I’ll introduce the concept of risk and explain why human health risk assessment is important.

Risk is something we all understand.  In fact, we all assess risk every day.  What is the risk of swimming in the ocean on a clear day?  Does the risk change if there are jellyfish? How about an approaching storm?  A shark swimming nearby?  We all understand these types of risk calculations at a very intuitive level.

Human health risk assessment isn’t so different.  It’s a process of characterizing the nature of an environmental risk (in many cases, a chemical exposure) and determining how large that risk is to humans.  It consists of four steps: (1) hazard identification, (2) dose-response assessment, (3) exposure assessment, and (4) risk characterization.  I will discuss each in future posts.

So why is human health risk assessment important?  Well, chemicals are a part of life.  Some exist naturally; some are made by humans and can be released to the environment.  They bring benefits to our lives, but like most things, they also come with risks.

Let’s consider a hypothetical example.  Suppose a factory produces something you use every day.  To make this product, the company uses several different chemicals, and some chemicals are produced during the manufacturing process as byproducts.  Some are released to the air and water and may get into the soil.  Let’s say this industrial site is located next to a river that leads to your local drinking water plant.  Are any of the chemicals in that water?  Are the levels safe for you to drink?  What about your child? What levels of the chemicals are safe for you to breathe?

Human health risk assessment helps answer questions like these.  It is a tool that helps local, state and federal governments make decisions about what levels of chemicals can be in drinking water; what additional controls are needed to keep levels emitted to the air at a safe level; and what levels need to be achieved to clean up a contaminated site.  From a public health perspective, this is pretty important stuff.

In the coming weeks, I’ll be posting more about EPA’s human health risk assessment work. Stay tuned for those posts, but in the meantime, you can learn more by going to http://go.usa.gov/KhCJ.

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 opinions expressed here are those of the author. They do not reflect EPA policy, endorsement, or action.

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Progress in Communities: It All Starts with Science

This week is the 43rd Anniversary of the establishment of the Environmental Protection Agency, and we are marking the occasion by revisiting how our collective efforts on behalf of the American people help local communities become cleaner, healthier, and more sustainable. As the Assistant Administrator for the Agency’s Office of Research and Development, I can’t help but see a strong undercurrent of science and engineering in every success story.

Over the past four plus decades, EPA scientists and engineers, along with their partners from across the federal government, states, tribes, academia, and private business, have supplied the data, built the computer models and tools, and provided the studies that have helped communities take action to advance public health and protect local environments.

In every area of environmental and human health action, EPA researchers have helped local communities make progress. While examples abound, here are just a few:
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Editor's Note: The views expressed here are intended to explain EPA policy. They do not change anyone's rights or obligations.

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100 Days of EPA Science, and Beyond

By Kacee Deener

Numeral 100 with clouds and sky in backgroundEPA recently highlighted some of the Agency’s achievements during Gina McCarthy’s first 100 days as Administrator, noting that we have made significant strides towards improving the health of American families and protecting the environment across the country.

One of the seven highlighted examples is “Taking Action on Toxics and Chemical Safety” – which includes strengthening chemical assessments through changes to the Agency’s Integrated Risk Information System (IRIS) Program.  In a recent blog post, I described these changes and why they make sense for the IRIS Program, the Agency, and the American people.  But the IRIS Program hasn’t stopped there.  We’ve been moving forward implementing the changes.  Since August, we have:

  1. Released early materials for several chemical assessments.  These materials highlight our thought process for determining which studies are most important for the assessment, help make sure we didn’t miss any important research, and help identify potential scientific controversies early on.
  2. Scheduled the first IRIS public bimonthly meeting (Dec. 12-13).  At this meeting we will discuss the early materials for three chemicals (ETBE, tert-butanol, and RDX) and the draft assessments and peer review charges for two chemical assessments (ethylene oxide and benzo[a]pyrene).
  3. Held a public scientific workshop to discuss the IRIS assessment of hexavalent chromium.  An important component of determining the cancer causing potential of ingested hexavalent chromium is understanding the rates at which this metal is effectively detoxified in the gastrointestinal tract.  EPA convened an expert panel to discuss this issue in September; more than 200 stakeholders participated!
  4. Scheduled a scientific workshop on mouse lung tumors.  At this workshop, which will be held in early 2014, experts will discuss the available data from studies of mouse lung tumors following exposure to chemicals and discuss the relevance of these tumors in mice to assessing human cancer risk.
  5. Released final IRIS assessments for biphenyl, 1,4-dioxane (inhalation update), and methanol (noncancer). These final assessments provide information on the health effects of these chemicals and toxicity values that risk assessors can use (along with exposure and other information) to make decisions to protect public health.
  6. Announced a workshop on formaldehydeThis workshop, which will be held in spring 2014, will focus on several scientific issues pertinent to assessing the potential health effects of inhaled formaldehyde.  We’re taking input on speakers/panelists and topics for three theme areas – you can send us your suggestions here.

I think you’ll agree we’ve been making tremendous progress!  These activities illustrate our commitment to scientific integrity, public input, and transparency as we work together to produce the highest quality scientific assessments to inform decisions to protect public health.

About the Author: Kacee Deener is the Communications Director in EPA’s National Center for Environmental Assessment, home of the IRIS Program.  She joined EPA 12 years ago and has a Masters degree in Public Health.

Editor's Note: The opinions expressed here are those of the author. They do not reflect EPA policy, endorsement, or action.

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Evaluating Studies to Understand if a Chemical Causes Cancer

IRIS graphic identifier

By Kacee Deener

When friends ask me what I do, I always mention the Integrated Risk Information System (IRIS) Program and explain that through IRIS, EPA scientists help protect public health by evaluating scientific information on the health effects that may result from exposure to environmental contaminants.  The questions inevitably come up—how do you do that, and what kind of information do you look at?

Scientists around the world contribute to the knowledgebase about the health effects of chemicals.  A particular area of interest has been chemicals’ potential to cause cancer.

Because EPA’s work must be grounded in the best possible science, we recently updated how we consider some of the cancer research of the Ramazzini Institute (RI), a laboratory in Italy known throughout the world for their extensive work in this area, completing cancer studies for more than 200 compounds.

A few years ago, the National Toxicology Program (NTP) identified differences of opinion between their own scientists and those from the Ramazzini Institute in diagnosing certain types of cancers in a study on methanol.  The scientific community—including EPA—was concerned, since Ramazzini data was included in IRIS evaluations.  We reviewed all of our IRIS assessments to determine which, if any, relied substantially on RI data; we found four that did, and we put those assessments on hold.

To follow up, EPA and the National Institute of Environmental Health Sciences cosponsored a group of scientists with expertise in evaluating tissue samples and making disease diagnoses, a Pathology Working Group (PWG), to review several Ramazzini Institute studies. They found some instances where respiratory infections in Ramazzini study animals made definitive diagnoses difficult, and disagreed with some Ramazzini diagnoses, primarily certain leukemias and lymphomas that had been identified. Therefore, EPA decided not to rely on RI data on lymphomas and leukemias in IRIS assessments. There was agreement, though, in diagnosing solid tumors, and EPA decided to continue to consider Ramazzini Institute solid tumor data in IRIS assessments.

This has been an important issue in the world of chemical risk assessment. Last week, this was highlighted once again when a paper authored by EPA scientists, Scientific Considerations for Evaluating Cancer Bioassays Conducted by the Ramazzini Institute, was published in Environmental Health Perspectives.  The article interprets Ramazzini Institute study results and compares their testing protocols with those used by other federal agencies.  The results were consistent with the PWG findings—Ramazzini Institute results for cancer endpoints other than lymphoma and leukemias, and some cases of tumors of the inner ear and cranium, are generally consistent with those of the National Toxicology Program and other laboratories.  The paper also notes that, while differences in Ramazzini Institute testing protocols can complicate the interpretation of study results, they may also provide chemical risk assessors with insights that might not be observed in other laboratories.

The short answer to my friends’ questions is that EPA works to use the best available science—from across the U.S. and around the world—to support IRIS and our other assessments designed to protect public health.

About the Author:  Kacee Deener is the Communications Director in EPA’s National Center for Environmental Assessment, home of the IRIS Program.  She joined EPA 12 years ago and has a Masters degree in Public Health.

Editor's Note: The opinions expressed here are those of the author. They do not reflect EPA policy, endorsement, or action.

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Writing Down IRIS

By Kacee Deener IRIS

As a scientist now working in science communications, I’m constantly surprised by the writing process.  You put something down on paper, revise it a few times, and then make tweaks here and there until you’re satisfied.  Then you look at it again later, and you make a few more changes.

Turns out lots of things in life are like that—including science programs.  In May 2009, EPA announced a new Integrated Risk Information System – or IRIS – assessment development process.

IRIS is an important program because it provides information on the health effects caused by exposure to chemicals in the environment.  People use IRIS, along with other science information, to inform decisions that protect public health across the U.S.

The new 2009 process was good for the IRIS Program.  But – as I’ve learned with writing – a few tweaks can make something even better.  Since 2009, we’ve learned a lot.  We’ve also received recommendations from the National Research Council (NRC) about improving IRIS assessments and about planning and scoping and stakeholder engagement in risk assessment.  So we’re making some common sense changes that will help us produce more high quality assessments in a timely and transparent manner.

In a nutshell, here’s what we are doing

  • Before beginning an assessment, we will meet with EPA’s regulatory programs – the folks who make decisions that help protect public health – to make sure we understand the big picture of why they need an assessment.
  • We will then hold a public meeting to discuss the plan for the assessment (so we better understand who needs it and why) and gather input about some technical aspects of developing the assessment (for example, are we concerned about people being exposed by breathing the chemical, ingesting it, or both?).
  • Next we will release a literature search for the chemical, evidence tables that summarize the critical scientific studies, and exposure-response figures that graphically depict the responses at different levels of exposure for each study in the evidence table. These materials highlight our thought process for determining which studies are most important for the assessment, help make sure we didn’t miss any important research, and help identify any potential scientific controversies early on.
  • We’re also using “stopping rules” so IRIS assessments are not delayed by ongoing research or scientific debate after certain points of the process have passed.
  • Finally, we’ve strengthened our practices for peer review and conflict of interest.

And this isn’t a complete list – you can read about all of the enhancements on our website.

These changes to IRIS are practical, common-sense improvements that emphasize scientific rigor and transparency.  They will also be good for our stakeholders, so like a well written story, it’s a win-win for everyone involved.

Like a committed science writer, we’ll always be revising whenever improvements are needed, but take a minute to check out the latest edition.  I think you’ll like the improvements.

About the Author: Kacee Deener is the Communications Director in EPA’s National Center for Environmental Assessment, home of the IRIS Program.  She joined EPA 12 years ago and has a Masters degree in Public Health.

Editor's Note: The opinions expressed here are those of the author. They do not reflect EPA policy, endorsement, or action.

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Team Dioxin – an Award Winning Group!

By Elizabeth Erwin

"Team Dioxin"

“Team Dioxin”

About three years ago, I came to EPA and joined the communications team in the organization that manages EPA’s Integrated Risk Information System (IRIS) Program (a human health assessment program that evaluates the health effects of exposure to environmental chemicals). I heard various chemical names mentioned all the time, but it seemed as if one in particular was mentioned more often than others—dioxin.

I quickly learned that EPA has a long history with dioxin, a highly toxic, persistent environmental chemical known to cause a number of adverse health effects.  For years, EPA and other federal agencies worked together to reduce known and measurable dioxin emissions in the United States.

In February 2012, EPA reached an enormous milestone by completing the long-awaited IRIS assessment for dioxin (focused on health effects other than cancer). The assessment provides much needed information on the potential noncancer health effects resulting from exposure to dioxin and, for the first time, an estimate of the amount of dioxin that one can ingest daily over a lifetime that is not likely to cause harmful health effects (the “oral reference dose”).

The assessment is an essential component of the Agency’s dioxin science plan as risk assessors, health professionals, and state, local, and international governments rely on its findings to guide decisions to protect public health.

This month, the team responsible for completing the dioxin assessment received some well-deserved recognition. On May 8 EPA’s “Team Dioxin” received a Federal Service Excellence Project Team Award. Team Dioxin includes Hisham El-Masri, Belinda Hawkins, Glenn Rice, Jeffrey Swartout, Linda Teuschler, Scott Wesselkamper, Michael Wright, and Bette Zwayer.

In 2009, this team of scientists was tasked with completing the dioxin assessment on an expedited schedule. Meeting this challenge placed them under intense pressure and required countless sacrifices, but at every turn they met the challenge.

“In order to meet the aggressive schedule outlined by [former] EPA Administrator Lisa P. Jackson, the team sacrificed time with family because they understood the significance of their work to the American people” explains Annette Gatchett, Director of NCEA’s Cincinnati branch where the dioxin team is headquartered.

Indeed, the team spent months pouring over the extensive, complex, and controversial science that exists on dioxin, evaluating over 1,000 published epidemiology and toxicology studies and analyzing numerous data sets on a variety of adverse health outcomes attributed to dioxin exposures.

Despite the sacrifices, the team’s effort was worth it. “Working on EPA’s dioxin report was extremely interesting and rewarding,” says Glenn Rice, one of the lead authors of the assessment. “Over the many nights and weekends of working on the project, I developed a sincere and deep appreciation for the expertise, dedication and senses of humor of my collaborators.”

Completing the IRIS assessment for dioxin (non-cancer) is an incredible achievement, one that I am grateful to have been at EPA to witness. Without a doubt, achievements such as Team Dioxin’s embody the Agency’s mission to protect human health and the environment and make me proud to come to work each day.

About the author: Elizabeth Erwin is a member of EPA’s science communication team where she helps make IRIS and other EPA science programs and assessments available and accessible.

Editor's Note: The opinions expressed here are those of the author. They do not reflect EPA policy, endorsement, or action.

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