IRIS

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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HERO: Easier Way to Retrieve Information

By Pawlos Girmay

I recently had an opportunity to speak with Gerry Gurevich, the technical lead for EPA’s Health and Environmental Research Online—or HERO—database, which serves as a central location for the scientific information EPA researchers use to develop environmental and health assessments. Gerry explained some of the benefits of the HERO database and the changes that will occur over the coming months.

For starters, HERO has greatly enhanced transparency by providing links to the references and abstracts of  the scientific literature used in two important types of Agency assessments:  (1) Integrated Risk Information System (IRIS) assessments, which evaluate information on the potential health effects that may result from exposure to environmental contaminants, and (2) Integrated Science Assessments (ISAs), reports that summarize the science related to the health and ecological effects caused by the six criteria air pollutants for which EPA develops National Ambient Air Quality Standards.

With approximately 725,000 references, there is an abundance of information. If you need a scientific reference from an ISA or IRIS assessment, HERO will have it!

While HERO is already a terrific resource, EPA is still committed to making changes to improve the database. New versions of HERO are being pushed out monthly to improve performance. EPA will continue to provide updates as needed to make HERO a beneficial tool for anyone seeking scientific information about EPA’s assessment work.

Obviously, HERO could not function without the hard work and dedication of the staff that have made the database what it is today. Joining Gerry Gurevich, who has been working with HERO for the past four years, is “TeamHERO” – a group of librarians and data specialists.

During my time in the EPA’s National Center for Environmental Assessment, I found HERO to be an extremely valuable tool to search for scientific information. As part of the Open Government Directive to conduct business with transparency, participation, and collaboration, HERO helps the public participate in EPA’s work by providing information about the data behind health assessments that inform decisions to protect public health.

With many new advances in technology taking place, I am sure HERO will continue to expand and enhance stakeholder’s experiences.  You can explore it yourself here: Health and Environmental Research Online.

About the Author: Pawlos Girmay is a student intern in EPA’s National Center for Environmental Assessment. He received his undergraduate degree from Howard University and his Masters of Science in Health Communications degree from Boston University.

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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Testing… Testing 1, 2, 3

By Janice Lee        

Arsenic element from periodic tableSo here we are preparing for the upcoming Public Stakeholder Workshop on the Integrated Risk Information System (IRIS) Program’s new health assessment of Inorganic Arsenic (January 8-9, 2013).  The goal of the public workshop is to provide an opportunity for stakeholders to share their views about the assessment.  

An IRIS assessment is important to organizations that make decisions about protecting public health because it provides information about a chemical’s hazard and the relationship between the dose of the chemical and the magnitude of its biological response or health effect.  

We’re interested in hearing from the public about what types of studies exist about inorganic arsenic and what is currently known about the chemical. We’re also interested in hearing why various organizations need a health assessment of inorganic arsenic.  For example, what sort of questions do they have to answer or what decisions do they have to make about the chemical?

The knowledge we gather from this important part of the process will help us better understand what should be included in the final assessment in order to meet the needs of the American public. 

You can participate in the workshop in person or remotely by webinar. The webinar option is great since many people who are interested in attending can’t come in person. Today we did a dry run to try out the webinar system and everything worked just fine. Now that we’re all set, I’m eager to see how many people join us using this technology.

As a graduate student, my doctoral work was on arsenic chemistry and health effects. One of the projects I worked on evaluated arsenic removal at a water treatment facility in Holly, MI. When I graduated, I thought I was done with arsenic. I just had to finish my manuscript and thought I would probably never work on arsenic again. Well, that was 10 years ago and here I am, the co-chemical manager for the inorganic arsenic assessment! 

I’m excited to be working on arsenic again, and in a different capacity this time around. Instead of doing research, I’m applying the research that has already been done to inform the development of an assessment that will be used as part of the science to inform future public health decisions about inorganic arsenic.

For more information on the workshop, check out the website: http://www.epa.gov/iris/publicmeeting/arsenic.htm

Please join us. We’re looking forward to hearing from you next week!

About the author:  Janice Lee is a health scientist in EPA’s IRIS Program. She has been with EPA for the past seven years and has a Ph.D. in Environmental Health Sciences.

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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Stakeholder Engagement: The key to building more sustainable systems within the IRIS Program

By Elizabeth Corona

 

On November 13, I attended a public stakeholder meeting for EPA’s  Integrated Risk Information System (IRIS) Program. During the meeting, IRIS leadership spoke about changes being considered to improve the Program, and stakeholders shared their views on the changes and made other recommendations.

Dr. Ken Olden, Director of EPA’s National Center for Environmental Assessment (NCEA), home of the IRIS Program, shared his vision for IRIS.  This vision is based on the idea that proactive stakeholder engagement and transparency will increase the scientific quality of IRIS assessments and the efficiency of the assessment development process. Vince Cogliano, Acting Director of the IRIS Program, then talked about some of the specific changes that stakeholders can expect in the coming year, such as improving peer review and using systematic review – an automated process to identify, evaluate, and integrate data – to develop IRIS assessments. 

The majority of the meeting, however, focused on listening to stakeholders. A panel of individuals from various stakeholder groups shared their views about IRIS. An open forum followed, during which participants (both in person and online), panelists, and NCEA leadership had a lively discussion. 

Stakeholder engagement is widely recognized as an essential element of sustainable organizational systems.  Meaningful engagement can help build mutual respect between parties, and ensure the quality and timeliness of outcomes. Its importance was recently emphasized by the National Research Council in their 2011 report “Sustainability and the U.S. EPA” (also known as the “Greenbook”). For several years now, EPA has been working to infuse sustainability and systems thinking into its research and other activities. This meeting was an excellent example of how the IRIS Program has embraced these concepts.

With sustainability as the new guiding principle for IRIS, the Program will become more resilient, enabling scientists to more easily take on new challenges and adjust as new risk assessment methods and types of data become available. Many stakeholders who participated in the November 13 meeting seemed excited about these changes and eager to see how our new direction improves the Program.

However, this is only the beginning. The long-term sustainability of the IRIS Program will require continued and frequent engagement with stakeholders representing a wide range of perspectives.

To make sure your voice is heard, visit the meeting webpage, view the meeting materials, provide your input through the “Virtual Comment Box,” and be on the lookout for the next opportunity to provide input!

For more information on the IRIS Program, planned changes, or future opportunities to engage, please visit the IRIS website or subscribe to the monthly Human Health Risk Assessment (HHRA) Bulletin. To subscribe, click here and enter your e-mail address.  

About the author: Elizabeth Corona is the Program Associate for EPA’s Human Health Risk Assessment (HHRA) research program. She joined the EPA two years ago and has a Ph.D. in Organizational Systems, with a focus on sustainability.

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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Your Voice Matters to EPA’s IRIS Program

By Kacee Deener

Last month, I attended an internal EPA meeting to discuss plans for developing an Integrated Risk Information System (IRIS) assessment for inorganic arsenic. The purpose of the meeting was to talk with EPA’s regulatory programs about the scope of the assessment.

An IRIS assessment is only part of the information EPA uses to make decisions—it provides information about the chemical’s hazard and the relationship between the dose of the chemical and the magnitude of the biological response or health effect. I know from my days as a public health student that IRIS is really important to environmental and public health practitioners in EPA and across the country—they use the database every day to help inform decisions to protect public health. So it’s important that we understand what questions people may have to answer about a chemical before beginning an assessment. This helps us appreciate the big picture of the work we’re doing; it also helps us focus the assessment so it’s most useful to the people who use IRIS. For example:

  • Are there upcoming rules where inorganic arsenic will be a risk driver?
  • Are EPA regions facing decisions about cleaning up sites contaminated with inorganic arsenic?
  • What types of toxicity values does the Agency and other stakeholders need to do its work?

These are just some of the questions that were asked during this internal meeting.

This type of meeting will become more common in the IRIS Program. However, we won’t just meet internally about these questions. We want to expand the conversation about IRIS with all stakeholders, including state and local health agencies, industry, environmental and public health organizations, the general public, and any individual or group that has an impact on, an interest in, or could be affected by an IRIS assessment.

We understand that IRIS assessments inform the decisions that EPA makes every day to protect public health and the environment. We know these decisions can have a big impact on human health, the environment, and the economy. Because of this, stakeholder engagement is critical to promote transparency and understand the views and input of those impacted by IRIS.

On November 13, we will hold a public stakeholder meeting about IRIS, and we are inviting anyone who’s interested to participate. But this is only the beginning—we plan to have an ongoing dialogue with stakeholders about the IRIS Program and specific IRIS assessments. We are interested in hearing what you think, so come join us on November 13. We would love to hear from you!

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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Science Does Truly Matter

By: Dahnish Shams

As an EPA summer intern, I got a firsthand look at how essential science is to the operations of the Agency and of its immense importance to us all.

Stationed at EPA’s National Center for Environmental Assessment, I was quickly introduced to some of the science products that support so much of what EPA does to protect human health and the environment. Chemical assessments in EPA’s Integrated Risk Information System (IRIS) Program and Integrated Science Assessments (ISAs) for the six criteria air pollutants (ozone, particulate matter, carbon monoxide, sulfur oxides, nitrogen oxides, and lead) inform the public and decision makers of the potential hazards threatening public health and the environment. These scientific products provide the basis for many of the rules the agency generates.

Yet, when you look beyond the products and their implications, what I have learned during my 10-week internship is that so much of the Agency’s work is truly defined by individuals, such as the scientists, communications staff, and support specialists that work as a team to conduct assessments. I saw that despite numerous obstacles, there is continued determination by this team of professionals to consistently devise strategies and methods to overcome the challenges that naturally arise as chemicals and humans interact in increasingly complex ways with the environment.

So as I conclude my internship, this blog post is meant to acknowledge the passion, determination, and teamwork exemplified by the people that I have met at the Agency this summer. These qualities are reflected through the continued efforts to improve IRIS chemical assessments, through climate assessments of ecosystems from across the country, and by the continual production of high quality ISAs – all of which provide a critical part of the scientific foundation for EPA’s decisions to protect human health and the environment.

If there is one message that I will take away from the Agency this summer, and one that I hope you gather from this post, is that I am proud to have been associated with EPA, and with the National Center for Environmental Assessment and the people that work here in particular. Though there are challenges in assessing the environment in the 21st century, they showed me through their passion, dedication, and teamwork that producing high quality science does truly matter.

About the Author: Dahnish Shams was a summer intern with EPA’s National Center for Environmental Assessment.

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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Protecting Human Health: That Explains It!

By Elizabeth Erwin

Child plays with water.

EPA's IRIS Program provides health effects information to help protect public health and the environment.

This past December, I had the opportunity to attend the annual Society for Risk Analysis (SRA) meeting in Charleston, SC. One of my responsibilities was to cover a symposium on EPA’s Integrated Risk Information System (IRIS) chaired by Becki Clark, Acting Director of my EPA office, the National Center for Environmental Assessment (NCEA).

Over the past year, I have become very familiar with IRIS, as a large part of my job is to communicate to the public, other federal agencies, and stakeholders what IRIS is, what it isn’t, and what it does to protect human health and the environment.

When I mention IRIS to friends and family, I’m often met with quizzical expressions. After several failed attempts at an explanation that included chemical names like “hexabromocyclododecane” and other scientific mouthfuls, I began giving them the bottom line: while IRIS assessments are not regulations or by themselves full risk assessments, the information they contain is an important basis for decisions that protect the health of all Americans.

Obviously, each of us has at some point taken a drink of tap water, inhaled deeply while enjoying an afternoon outside, or tracked soil into our homes. We perform these and dozens of other mundane daily activities without giving a second thought to potential harmful consequences, thanks in large part to EPA’s actions, many of which are based on IRIS human health assessments of more than 550 chemical substances.

Earlier this year, EPA finalized the long-awaited non-cancer assessment for dioxin, a major milestone for the Agency. Dioxins are toxic chemicals that exist in the environment naturally and can be released in greater quantities through forest fires, backyard burning of trash, certain industrial activities, and residue from past commercial burning of waste.

This final IRIS assessment is the latest effort in a successful, coordinated strategy by the Federal government that has reduced known and measurable air emissions of dioxins in the United States by about 90 percent since 1987.

Risk assessors, health professionals, and state, local, and international governments can now use these latest findings to guide future efforts to identify any residual sources of dioxin and protect public health.

Achievements such as this are what make me proud to be associated with EPA’s IRIS Program, especially when I get that oh-so-common question, “So, what do you do?” Attending the IRIS presentation reminded me that to answer that question, all I have to say is simply, “I help support the science that protects human health” – because that’s exactly what the IRIS Program does.

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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