IRIS

Feb 12, 2015

Moving Away From “High Risk”

EPA National Center for Environmental Research, EPA’s Integrated Risk Information System (IRIS) Program, Government Accounting Office, IRIS 1 Comment

By Lou D’Amico, Ph.D. and Samantha Jones, Ph.D.

Yesterday the Government Accountability Office (GAO) released their biennial High Risk Report, which lists government functions and operations identified as needing attention by Congress and the Executive Branch. EPA’s IRIS Program is on the list along with the Toxic Substances Control Act (TSCA) under the broader area, Transforming EPA’s Processes for Assessing and Controlling Toxic Chemicals. For the first time, GAO has provided ratings in five criteria to help programs gauge their progress in resolving the high risk designation.

GAO found that, specific to the IRIS Program, EPA has:

Met, a demonstrated commitment to, and top leadership support for, addressing problems;
Partially met, the development of a corrective action plan;
Partially met, instituting a program to monitor corrective measures;
Not met, demonstrating progress in implementing corrective measures; and
Not met, demonstrating the capacity to address problems.

We think this report shows improvement while acknowledging that there is more to do. The recommendations received from GAO, the National Research Council (NRC), and our Scientific Advisory Board Chemical Assessment Advisory Committee (SAB CAAC) provide important ongoing feedback and a framework through which EPA will ensure, as part of a multiyear process, that the IRIS Program produces timely, transparent, and high-quality scientific assessments.

As GAO noted, EPA’s leadership has reaffirmed the importance of the IRIS Program. In the coming weeks and months, you’ll hear more about IRIS activities that address issues raised by the GAO. An important one will be the IRIS multi-year plan, which reflects a reprioritization of the chemicals on the IRIS agenda to best meet Agency needs. Also, soon-to-be announced workshops will allow scientists in the IRIS Program to benefit from in-depth scientific discussions that directly inform ongoing work in our assessments.

The IRIS Program has taken a number of steps to strengthen, streamline, and clarify the science presented in our assessments. To increase capacity in an ever-changing environment, the IRIS Program has restructured the process for developing assessments, including the use of workgroups that bring together individuals with common expertise by scientific discipline (e.g., neurotoxicity), to evaluate a specific hazard. We’ve also recently implemented an executive review committee to ensure that scientific decisions are discussed by a greater number of senior scientists and managers within EPA’s National Center for Environmental Assessment, and to maintain quality and consistency across assessments.

Demonstrating progress is the criterion that presents a significant challenge to IRIS. The number of posted final assessments is only one measure of progress. In recent years, the same staff and managers that work on assessments have also been implementing recommendations from the GAO and NRC. One of those recommendations, adopting systematic review methodologies, is an ongoing effort. In the coming months, the public will see new sections of the IRIS Handbook, including a collection of the procedures and protocols we’ll use to implement systematic review in the IRIS Program. It is also important to advance chemicals at every stage of the IRIS process. Since 2013, IRIS has held bimonthly public science meetings on 12 chemicals under assessment. Finally, it’s important to consider the impact of these assessments. How should the IRIS Program balance the completion of complex assessments with widespread interest (which require greater resources and time) with those that may present fewer challenges and have comparatively less interest, but still have important public health impacts? The recently finalized IRIS assessment of Libby Amphibole Asbestos is only one assessment, but the impact to other federal and state agencies, and local communities is significant. Regardless of the metrics, the IRIS Program is committed to increasing productivity to meet the needs of the Agency and the public.

The independent reviews provided by the GAO and SAB CAAC, as well as the recent NRC review of the IRIS process, have validated a number of the steps taken by the IRIS Program. We will continue to evolve and we hope that stakeholders will continue to share their opinions with us – either in the comments sections of blog posts, on the IRIS general comments docket, or at some of our public meetings and workshops. We want to hear from you!

About the Authors: Lou D’Amico is the Acting Communications Director for NCEA. Samantha Jones is the Associate Director for Science in the IRIS Program.

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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Oct 31, 2014

This Week in EPA Science – Halloween Edition

Broadcom MASTERS, EPA’s Integrated Risk Information System (IRIS) Program, IRIS, STEM 0 Comments

By Kacey Fitzpatrick

What do most movies about zombies, aliens, robots, and monsters have in common with Research Recap? It All Starts with Science!

Of course, you can’t always believe what you see in the movies. Here’s some real research that’s been highlighted by EPA this week (and won’t give you nightmares). Happy Halloween!

Prescriptions for Cleaner Waterways Left with expired, unwanted prescriptions, many people will pour them down the sink or flush them away. In a recently published study, EPA scientist Christian Daughton presents ways to reduce the active ingredients of pharmaceuticals from getting into our waterways. Read more.
Strengthening IRIS: Cultivating Broad Scientific Input EPA has embraced recommendations by the National Research Council to broaden the input they receive while conducting health assessments in the Agency’s Integrated Risk Information System (IRIS). “Bringing more scientific minds to the table will only strengthen our assessments by encouraging a more robust discussion,” writes IRIS scientist Louis D’Amico, Ph.D. Read more.
Broadcom MASTERS EPA’s Drs. Denice Shaw and Tina Bahadori, along with Melissa Anley-Mills, participated in a Science, Technology, Engineering, and Mathematics (STEM) event with the Broadcom MASTERS finalists. Broadcom MASTERS is a national STEM competition for U.S. 6th, 7th, and 8th graders that aims to inspire and encourage future scientists, engineers, and innovators. Read more.

If you have any comments or questions about what I share or about the week’s events, please submit them below in the comments section!

About the Author: Kacey Fitzpatrick is a student contractor and writer working with the science communication team in EPA’s Office of Research and Development.

Oct 27, 2014

Strengthening IRIS: Cultivating Broad Scientific Input

Integrated Risk Information System, IRIS, National Research Council, Review of EPA's Integrated Risk Information System (IRIS) Process (2014), risk assessment 0 Comments

By Louis D’Amico, Ph.D.

As 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.

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.

Jul 8, 2014

Improving IRIS: Please Join the Conversation

environmental, health assessment, Integrated Risk Information System (IRIS) Program, IRIS, National Research Council, NRC, Review of EPA’s Integrated Risk Information System Process 7 Comments

By Kacee Deener

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.

Jun 25, 2014

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

Human Health Risk Assessment, Integrated Risk Information System, IRIS, IRIS Public Meetings, transparency 2 Comments

By Kacee Deener

In 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.

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.

May 15, 2014

A Job Worth Doing is Worth Doing Together

arsenic, Inorganic Arsenic, Integrated Risk Information System (IRIS), IRIS 2 Comments

By Janice Lee

Most everyone recognizes the value of teamwork. We learned this from a young age in school, and most people can point to a professional experience where a project has improved because of group input. For me, a terrific example is the inorganic arsenic health assessment that EPA is currently developing through our Integrated Risk Information System (IRIS)—a program that provides information on the health effects that may result from exposure to environmental contaminants.

Arsenic is well known—it’s been used since ancient times for a variety of purposes, it had a major role in the Hollywood movie Arsenic and Old Lace, and many people are familiar with health issues that occur in areas where naturally-occurring arsenic shows up in high levels in drinking water.

Throughout 2013, our team met with a lot of people who will use our inorganic arsenic assessment once it’s developed. We learned a lot from those conversations, including several things that will ultimately improve our assessment and make it more useful to the people who make decisions to protect public health. For example, we had initially planned to focus our assessment on oral exposures—the kind you might get from drinking water or eating food contaminated with inorganic arsenic. Based on the feedback we heard from others, we realized it was important to include information about the potential health effects of inhaling inorganic arsenic, too. We were also reminded that providing information about those populations that may be more sensitive to the effects of inorganic arsenic is important to the users of the inorganic arsenic assessment.

We also learned that many people wanted to continue to have discussions on science issues that may inform the development of the assessment. We agreed this was important, and in response started an arsenic webinar series.

To date we have held eight webinars on various topics relevant to assessing the human health risks of exposure to inorganic arsenic. For example, we held one webinar on inorganic arsenic and its potential effects on children’s neurodevelopment. We heard that the most sensitive endpoints to look at when examining the relationship between arsenic and children’s neurodevelopment are IQ and behavior. We held another one on environmental justice issues related to inorganic arsenic. During that one, we heard about the importance of considering social stressors when looking at susceptibility. This includes access to nutritional food, health care and prenatal care, and housing conditions.

I have really enjoyed holding these webinars. The talks have been informative, and it has been a great forum for discussion and input. I am happy to note that we are committed to engaging partners and public stakeholders throughout the development of the inorganic arsenic assessment. The next opportunity to provide feedback will be the upcoming IRIS June Bimonthly Public Meeting.

We have released several products for public input and discussion, including an assessment development plan, literature search, risk of bias evaluations for the studies under consideration, evidence tables, and some qualitative summary information about mode of action hypotheses (the chain of events that happens in the body after exposure to cause a health effect).

In addition, we will also be discussing key science issues relevant to assessing the health hazards of inorganic arsenic. A list of these issues is available on our website. We encourage you to help us identify additional science issues that you think are important.

These public discussions will ultimately help shape the science of our assessment. We hope you can join us for the conversation—your input could prove to be another terrific example of the power of teamwork!

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.

May 6, 2014

National Academies’ Report Shows that EPA has Strengthened IRIS Program

EPA Connect, Integrated Risk Information System, IRIS, National Academies of Science, National Research Council, risk assessment 0 Comments

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

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.

Read the rest of the post.

May 6, 2014

National Academies’ report shows that EPA has strengthened IRIS program

chemical safety, dioxin, environmental information, environmental scientists, Human Health, Integrated Risk Information System, IRIS, science 0 Comments

By Lek Kadeli

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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Apr 21, 2014

Is this Hazardous?

(ISAs), 4-dioxane, Human Health Risk Assessment, Integrated Risk Information System (IRIS), Integrated Science Assessment for Lead, Integrated Science Assessments, IRIS, IRIS assessment of 1, NAAQs, National Ambient Air Quality Standards (NAAQS) 0 Comments

By Kacee Deener

How do you know when something isn’t good for you? Sometimes it goes without saying (rattlesnake venom), and sometimes it’s not as obvious and requires deeper evaluation.

I recently kicked off a blog series about human health risk assessment and described its four-step process. Remember that hypothetical factory? How do we know if the chemicals being released are harmful? We use a process known as “hazard identification” to identify the types of health problems a chemical could cause (like cancer or respiratory effects).

Examples of two EPA programs that develop hazard identifications are: (1) the Integrated Risk Information System (IRIS) program and (2) the Integrated Science Assessment (ISA) program. Through IRIS, Agency researchers provide health effects information on environmental chemicals. ISAs provide health effects information to inform the National Ambient Air Quality Standards for the six criteria air pollutants.

So, how do we do this? We start by searching the scientific literature to compile all of the studies that look at a chemical’s effects. In IRIS assessments, we describe how we search the literature using, in part, a diagram. You can see an example of that here (pages 1-2). We then organize the information into the categories of health effects seen in the studies, (e.g., kidney or reproductive effects) and summarize certain features of each study, such as the level and route of exposure. We also look at each study’s quality (e.g., was the study designed and conducted well? was it peer reviewed?). Finally, we evaluate the overall “weight of evidence” to answer the question “does the agent cause the health effect?”

In some cases, EPA has developed “descriptors” for doing this. The Preamble to IRIS assessments provides more information (you can see an example here on page xxii). In other words, we provide text describing how likely it is that a health effect is associated with a chemical exposure. For example, in the recent IRIS assessment of 1,4-dioxane, we found that the chemical is likely to be carcinogenic to humans. In our recent ISA for Lead, we found, among other things, that there is a “causal relationship” between lead exposure and cognitive function decrements in children and a “likely causal relationship” between lead exposure and inflammatory responses in adults.

We’ve been working to improve the way we systematically review evidence when identifying hazards. In fact, we recently held a workshop on this topic. We’ve also started releasing the literature search strategy, along with evidence tables summarizing the critical studies, early in the process of developing an assessment. We follow that up with a public meeting to discuss the materials. We held the first of these meetings on December 12-13. Our next meeting is scheduled for April 23. Join us to provide your input, and don’t forget to check back in a few weeks for my next post!

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.

Apr 3, 2014

Human Health Risk Assessment—What it’s all about

dose-response assessment, environmental risk, exposure assessment, hazard identification, Human Health Risk Assessment, Integrated Risk Information System, IRIS, National Center for Environmental Assessment, risk characterization 4 Comments

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.

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