[House Hearing, 116 Congress] [From the U.S. Government Publishing Office] EPA'S IRIS PROGRAM: REVIEWING ITS PROGRESS AND ROADBLOCKS AHEAD ======================================================================= JOINT HEARING BEFORE THE SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT SUBCOMMITTEE ON ENVIRONMENT COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY HOUSE OF REPRESENTATIVES ONE HUNDRED SIXTEENTH CONGRESS FIRST SESSION __________ MARCH 27, 2019 __________ Serial No. 116-9 __________ Printed for the use of the Committee on Science, Space, and Technology [GRAPHIC NOT AVAILABLE IN TIFF FORMAT] Available via the World Wide Web: http://science.house.gov __________ U.S. GOVERNMENT PUBLISHING OFFICE 37-709PDF WASHINGTON : 2019 -------------------------------------------------------------------------------------- COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY HON. EDDIE BERNICE JOHNSON, Texas, Chairwoman ZOE LOFGREN, California FRANK D. LUCAS, Oklahoma, DANIEL LIPINSKI, Illinois Ranking Member SUZANNE BONAMICI, Oregon MO BROOKS, Alabama AMI BERA, California, BILL POSEY, Florida Vice Chair RANDY WEBER, Texas CONOR LAMB, Pennsylvania BRIAN BABIN, Texas LIZZIE FLETCHER, Texas ANDY BIGGS, Arizona HALEY STEVENS, Michigan ROGER MARSHALL, Kansas KENDRA HORN, Oklahoma NEAL DUNN, Florida MIKIE SHERRILL, New Jersey RALPH NORMAN, South Carolina BRAD SHERMAN, California MICHAEL CLOUD, Texas STEVE COHEN, Tennessee TROY BALDERSON, Ohio JERRY McNERNEY, California PETE OLSON, Texas ED PERLMUTTER, Colorado ANTHONY GONZALEZ, Ohio PAUL TONKO, New York MICHAEL WALTZ, Florida BILL FOSTER, Illinois JIM BAIRD, Indiana DON BEYER, Virginia VACANCY CHARLIE CRIST, Florida VACANCY SEAN CASTEN, Illinois KATIE HILL, California BEN McADAMS, Utah JENNIFER WEXTON, Virginia ------ Subcommittee on Investigations and Oversight HON. MIKIE SHERRILL, New Jersey, Chairwoman SUZANNE BONAMICI, Oregon RALPH NORMAN, South Carolina, STEVE COHEN, Tennessee Ranking Member DON BEYER, Virginia ANDY BIGGS, Arizona JENNIFER WEXTON, Virginia MICHAEL WALTZ, Florida ------ Subcommittee on Environment HON. LIZZIE FLETCHER, Texas, Chairwoman SUZANNE BONAMICI, Oregon ROGER MARSHALL, Kansas, Ranking CONOR LAMB, Pennsylvania Member PAUL TONKO, New York BRIAN BABIN, Texas CHARLIE CRIST, Florida ANTHONY GONZALEZ, Ohio SEAN CASTEN, Illinois JIM BAIRD, Indiana BEN McADAMS, Utah VACANCY DON BEYER, Virginia C O N T E N T S March 27, 2019 Page Hearing Charter.................................................. 2 Opening Statements Statement by Representative Mikie Sherrill, Chairwoman, Subcommittee on Investigations and Oversight, Committee on Science, Space, and Technology, U.S. House of Representatives.. 9 Written Statement............................................ 11 Statement by Representative Ralph Norman, Ranking Member, Subcommittee on Investigations and Oversight, Committee on Science, Space, and Technology, U.S. House of Representatives.. 13 Written Statement............................................ 15 Statement by Representative Lizzie Fletcher, Chairwoman, Subcommittee on Environment, Committee on Science, Space, and Technology, U.S. House of Representatives...................... 17 Written Statement............................................ 19 Statement by Representative Roger Marshall, Ranking Member, Subcommittee on Environment, Committee on Science, Space, and Technology, U.S. House of Representatives...................... 21 Written Statement............................................ 23 Statement by Representative Frank D. Lucas, Ranking Member, Committee on Science, Space, and Technology, U.S. House of Representatives................................................ 25 Written Statement............................................ 26 Written statement by Representative Eddie Bernice Johnson, Chairwoman, Committee on Science, Space, and Technology, U.S. House of Representatives....................................... 29 Witnesses: Panel 1: Dr. Jennifer Orme-Zavaleta, Principal Deputy Assistant Administrator for Science and Senior Advisor, Office of Research and Development, Environmental Protection Agency Oral Statement............................................... 31 Written Statement............................................ 33 Mr. Alfredo Gomez, Director, Natural Resources and Environment, Government Accountability Office Oral Statement............................................... 41 Written Statement............................................ 43 Discussion....................................................... 58 Panel 2: Dr. Bernard D. Goldstein, Professor Emeritus and Dean Emeritus at University of Pittsburgh Graduate School of Public Health Oral Statement............................................... 75 Written Statement............................................ 77 Dr. Ivan Rusyn, Professor, Department of Veterinary Integrative Biosciences; Chair, Interdisciplinary Faculty of Toxicology; and Director, Superfund Research Center, Texas A&M University Oral Statement............................................... 84 Written Statement............................................ 86 Dr. Julie E. Goodman, Principal, Gradient Oral Statement............................................... 97 Written Statement............................................ 99 Ms. Wilma Subra, President, Subra Company; and Technical Advisor, Louisiana Environmental Action Network Oral Statement............................................... 103 Written Statement............................................ 105 Discussion....................................................... 123 Appendix I: Answers to Post-Hearing Questions Dr. Jennifer Orme-Zavaleta, Principal Deputy Assistant Administrator for Science and Senior Advisor, Office of Research and Development, Environmental Protection Agency...... 140 Mr. Alfredo Gomez, Director, Natural Resources and Environment, Government Accountability Office............................... 147 Appendix II: Additional Material for the Record Letter from the American Chemistry Council submitted by Representative Ralph Norman, Ranking Member, Subcommittee on Investigations and Oversight, Committee on Science, Space, and Technology, U.S. House of Representatives...................... 150 Letter from the Colorado Department of Public Health & Environment submitted by Representative Lizzie Fletcher, Chairwoman, Subcommittee on Environment, Committee on Science, Space, and Technology, U.S. House of Representatives........... 155 EPA Executive Summary submitted by Representative Bill Foster, Committee on Science, Space, and Technology, U.S. House of Representatives................................................ 157 EPA'S IRIS PROGRAM: REVIEWING ITS PROGRESS AND ROADBLOCKS AHEAD ---------- WEDNESDAY, MARCH 27, 2019 House of Representatives, Subcommittee on Investigations and Oversight, joint with the Subcommittee on Environment, Committee on Science, Space, and Technology, Washington, D.C. The Subcommittees met, pursuant to notice, at 10:01 a.m., in room 2318 of the Rayburn House Office Building, Hon. Mikie Sherrill [Chairwoman of the Subcommittee on Investigations and Oversight] presiding. [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Chairwoman Sherrill. This hearing will come to order. Without objection, the Chair is authorized to declare recess at any time. Good morning, and welcome to the Investigations and Oversight Subcommittee's first hearing of the 116th Congress. I'm pleased to work alongside Ranking Member Norman of South Carolina and look forward to a productive and collaborative relationship. This is also a joint Subcommittee hearing with the Environment Subcommittee, and I'm very pleased to welcome my fellow Chair Mrs. Fletcher, who's on her way, and her counterpart in the minority, Representative Marshall of Kansas. I expect this is just the beginning of the cooperative partnership that our Subcommittees will enjoy during this Congress, and I look forward to continuing to work closely with you in the weeks and months ahead. In this first hearing, we are focusing on a subject that directly impacts the state of public health in this country. The EPA's (Environmental Protection Agency's) Integrated Risk Information System, or IRIS, is tasked with developing impartial, science-based assessments on toxicity of chemicals. It is considered the gold standard for chemical toxicity assessments in the United States, and note that IRIS is not itself a risk management program or a regulator. Instead, its findings are used by other branches of the EPA and State and local governments to inform guidelines and regulations about what levels of human exposure to a given chemical are acceptable. IRIS has produced toxicity assessments for a multitude of dangerous chemicals, including asbestos, mercury and ethylene oxide, to name a few. Unfortunately, we have learned in recent weeks that IRIS is being undercut by political leadership at the EPA. America needs a strong, empowered IRIS to provide EPA, States, tribes, municipalities, and communities everywhere with the best-available science regarding chemical toxicity. When IRIS is prevented from doing its work, the public is less informed, and therefore less safe. The public needs IRIS to be independent of outside influence, but the GAO report we will discuss today outlines troubling facts about political interference with IRIS. Political appointees at EPA have blocked the release of IRIS assessments, imposed new bureaucratic hurdles, and reduced the number of priority chemicals for IRIS to evaluate with no explanation. The formaldehyde assessment in particular has been ready to be released for over a year. Then-EPA Administrator Scott Pruitt said so himself in a January 2018 hearing before the Senate. Press reports indicate that IRIS has determined a connection exists between formaldehyde and leukemia. It is unacceptable for political considerations to suppress IRIS' findings. I fail to see any credible reason why findings of fact on chemical risks should be withheld from the public. EPA must release the IRIS formaldehyde assessment as soon as possible. EPA's management of the IRIS Program has prompted concern as well. In October 2018, 28 out of roughly 30 IRIS employees spent 25 to 50 percent of their time working on risk evaluations for a different EPA office. This kind of staff reassignment distracts IRIS from its core mission and deprives IRIS of the resources it needs to address its own work in a timely fashion. I'm very pleased to welcome the distinguished witnesses appearing here today. And in our two panels, we have government officials, eminent scholars, and community advocates who see the real-world impact of IRIS assessments. We appreciate your willingness to appear before our Subcommittees today. Protecting the public from toxic chemicals is a core function of the EPA, and IRIS is vital to the EPA's ability to accomplish its mission. I'm pleased to have the opportunity to continue this Committee's work to ensure that IRIS is allowed to do its job for the sake of public health. [The prepared statement of Chairwoman Sherrill follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Chairwoman Sherrill. The Chair now recognizes Mr. Norman for an opening statement. Mr. Norman. Thank you so much, Chairwoman Fletcher and Chairwoman Sherrill. Thank you all for convening this meeting. I want to thank the witnesses for taking your time to come. It's very important what you're doing. We're here today to examine the EPA's Integrated Risk Information System program, which is also called IRIS. This hearing provides an opportunity to review the issues and challenges that burden the IRIS Program, steps that IRIS has taken toward addressing these issues, and challenges that remain today. I'm hopeful that our expert panel of witnesses will paint a detailed picture of how to improve the IRIS Program and remedy issues that have burdened us for years. As Ranking Member of the Investigations and Oversight Committee, I approach this issue from an oversight perspective, focused on how to improve IRIS. With a background in business and real estate, I've learned how burdensome and costly, onerous regulations have become. My experience in the real estate business has also taught me a thing or two about construction. For example, one of the primary tenets of construction is that your foundation is critical. If you build atop a faulty foundation, the entire structure is at risk and likely ruined where it stands. As I understand it, IRIS assessments are analogous to a structural foundation. In preparing chemical assessments, IRIS conducts the first two steps of the risk assessment process: First, a hazard identification; second, a dose-response assessment. EPA's program and regional offices then rely on IRIS assessments and the foundation for conducting the last two steps of the risk assessment process, including an exposure assessment and a risk characterization. As with a structural foundation, if an IRIS assessment is based on flawed information, or is itself faulty, then it jeopardizes all subsequent work that builds atop a faulty foundation. As a result, faulty assessments can lead to bad regulations and unnecessary public health scares. The IRIS Program must continue to address transparency issues that have plagued it over the past decade because Americans need assurance that sound science forms the foundation for government regulations. The U.S. Government Accountability Office (GAO) added IRIS to its list of government programs that are highly vulnerable to risk of waste, fraud, abuse, and mismanagement in 2009. IRIS was added to GAO's ``High-Risk List'' because actions were needed to streamline and increase the transparency and the dependency of IRIS assessments. Despite attempts at improvement and efforts to remedy its challenges over the past decade, IRIS remains on the High-Risk List today. In addition to its High-Risk List, GAO recently published a report that examined IRIS' efforts to improve its chemical assessment process and implement outstanding recommendations. While GAO commended IRIS for its efforts to address identified challenges, it also appropriately recognized that there remained much room for much improvement, especially with respect to issues of timeliness and transparency. I want to thank the GAO for its great work. However, I was puzzled by certain findings regarding EPA leadership. In both reports, GAO seemed to fault EPA's leadership for delaying IRIS' progress. It also appeared that EPA leadership was chastised for failing to publicly commit to making IRIS a top priority, as was done by a previous Administrator, under a prior Administration. I would suggest that a brief pause may have been necessary to adequately address the issues and challenges that IRIS faces and develop a plan of action for future progress. For example, think about repairing a rollercoaster. If you don't try to fix a malfunctioning rollercoaster while it's rolling around full of people. Instead, you suspend operations, you pull the cars off the track for evaluation, which makes for a better ride and safer in the end. Perhaps delays due to EPA leadership deliberation and assessment of IRIS should be handled in a similar fashion. Despite its issues and challenges, the IRIS Program must still serve a critical function. And everyone here today recognizes the importance of ensuring Americans are protected from the dangers and hazards that IRIS aims to combat. It is for this reason that we must ensure IRIS' work is transparent, scientifically sound, and carried out in a timely and an efficient manner. I look forward to a productive and insightful discussion with our distinguished witnesses about the issues and challenges that the IRIS Program faces and the efforts that IRIS has made in remedying them, and what remains to be done to ensure that IRIS lives up to its potential. Thank you, Madam Chairwoman. I yield back. [The prepared statement of Mr. Norman follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Chairwoman Sherrill. Thank you, Mr. Norman. The Chair now recognizes the Chairwoman for the Subcommittee on the Environment, Mrs. Fletcher, for an opening statement. Mrs. Fletcher. Thank you, Madam Chairwoman. Good morning. I would like to join the Chairwoman and Ranking Member Norman in welcoming all of our witnesses on both panels here today. The EPA's IRIS Program conducts human health assessments that look at the health effects of chemical exposures in the environment. IRIS assessments are unique in providing information on chemical exposures and environmental hazards that may affect the general population, including children and the elderly, and that can occur over a lifetime. IRIS assessments follow a thorough process that includes internal and external peer review, as well as opportunity for public input. While the IRIS Program suffered from timeliness and transparency issues earlier this decade, the program has incorporated many recommendations from the GAO and the National Academies of Sciences that have improved its processes. The IRIS Program was intentionally placed in EPA's Office of Research and Development, a nonregulatory program office at the Agency, to ensure that only credible science guided the development of its impartial assessments, which are not regulatory in nature. There are many Federal, State, and local stakeholders, however, that rely on IRIS assessments to help make regulatory decisions that protect public health. Program and regional offices within the EPA routinely rely on IRIS assessments to guide their risk-management decisions. IRIS assessments are not only considered to be--are not considered to be duplicative of other Federal chemical assessments like those carried out under the EPA's Toxic Substances Control Act, or TSCA. This is why the recent series of announcements by the EPA removing the chemical formaldehyde from its IRIS workflow and adding it to its TSCA workflow is concerning. It appears to reset the clock on a late-stage IRIS assessment. Non-Federal stakeholders, including community groups and State, local, and tribal agencies, rely on IRIS assessments not only because of their rigor and thoroughness, but also because many of these entities do not have the capacity to conduct such thorough toxicity assessments on their own. The values derived in IRIS assessments are routinely the top choice of State regulatory bodies in their standard-setting work because they are the most thoroughly developed and vetted values available. Because of its rigorous process and the reliance of both Federal and non-Federal stakeholders of IRIS assessments to use them to direct risk-management decisions relating to public health, the program plays a unique role that is complementary to other review processes like TSCA. Given this background, the findings of the GAO's March 4 report detailing political interference in the publication of IRIS assessments raise serious concerns. The EPA is responsible for protecting public health and the environment through the application of sound science and should not be creating internal roadblocks to performing this critical mission. That is why I am glad we will be hearing from witnesses on both of our distinguished panels today, hearing from the EPA and GAO on the findings of this recent the GAO report and gaining a better understanding of the need for and importance of IRIS assessments, the improvements the program has made over the years, and the critical role these assessments play in protecting public health. And with that I yield back. [The prepared statement of Chairwoman Fletcher follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Chairwoman Sherrill. Thank you, Madam Chairwoman. And the Chair now recognizes Mr. Marshall for an opening statement. Mr. Marshall. Thank you, Chairwoman Fletcher and Chairwoman Sherrill, for holding this hearing, and thank you to the witnesses for being here today. The EPA's IRIS Program was established to identify and characterize the health hazards of chemicals found in the environment. The program conducts chemical hazard identification and dose response assessments, which serve as a source of toxicity information for EPA program and regional offices as well as State and local agencies. As a physician, I understand the importance of chemical toxicity assessments and their role in protecting the environment and advancing public health, particularly for sensitive populations such as children, pregnant women, and the elderly. Accordingly, it should be our top priority to ensure the underlying science that goes into these assessments is of the highest quality. Unfortunately, the IRIS Program has a poor track record in this department, and despite some recent progress by EPA leadership, many issues remain. Two of the most troublesome problems for the IRIS Program are its inability to produce final products in a timely manner and an unexplained lack of scientific transparency in the assessment process. Both the National Academy of Sciences (NAS) and the Government Accountability Office (GAO) have recently published reports that criticize the program and make recommendations for improvement. The National Academy of Sciences has published three reports detailing similar problems while making suggestions for reform and improvement of the program. The NAS reports in 2011 and 2014 found serious problems with IRIS and proposed sweeping recommendations to overhaul the program. If those recommendations had been fully implemented within the last 8 years, the program would be operating in a more functional manner and able to produce chemical assessments in a way that is timely, transparent to the public, and reflective of the best current scientific methodologies. Instead, we continue to live report to report, looking at incremental progress and an overall lack of tangible results. The 2018 NAS review commends IRIS for its progress to implement systematic review of chemical assessments. And while I agree that IRIS' progress is commendable, several other critical products and recommendations remain unaddressed and incomplete. Publication of a robust handbook that details internal process, incorporation of mode-of-action information, and utilization of a weight-of-evidence framework are a few examples of simple objectives that have not been accomplished despite recommendations to do that. I hardly find the 2018 NAS review consequential in its praise of the program. In fact, I think it is a clear indication that a lot of work remains. Likewise, the GAO has issued ongoing criticism of the program. In 2009, GAO added the IRIS Program to its High-Risk List, which identifies Federal programs with heightened vulnerabilities to fraud, waste, abuse, and mismanagement. Even with clear deficiencies pointed out and the EPA seemingly taking steps toward a few of the recommendations for improvement, the program continues to appear on the High-Risk List to this day. Separate of the High-Risk List, GAO recently issued a report that was largely critical of current EPA leadership and its efforts to manage and update the IRIS Program. Democrats and environmental groups continue to point to this report as evidence that the Trump Administration is trying to stifle science. On the contrary, I think these efforts are critical to overhauling a flawed program so it's responsive to program and regional office needs and best serve EPA's core mission. The program has many issues that need to be addressed, and EPA leadership is taking necessary steps to do just that. One of the most troubling issues with IRIS is the publication of misleading or questionable information that can create confusion for Americans regarding the health risks associated with a given chemical. The 2016 IRIS assessment for ethylene oxide is a prime example. Naturally produced by the human body and plants, ethylene oxide is produced commercially to sterilize medical equipment. OSHA (Occupational Safety and Health Administration) set a safety standard of 1 part per million for workers exposed 8 hours a day, 5 days a week. This seems to be a reasonable value given that high, long-term exposure may increase cancer risks. EPA's IRIS Program, however, set a lower risk value at 100 parts per quadrillion. And I think that's about a difference of 10 to the 9th. That value is 19,000 times lower than naturally occurring levels of ethylene oxide in the human body. Essentially, this assessment correlates to a normal human metabolism, and breathing ambient air is enough to cause cancer. It is clear that much work remains before IRIS assessments can be tabbed as the gold standard review that the program was established to be. Meeting objective and transparent standards for evaluating chemical risks will require substantial changes and improvements to the program. I'm hopeful that one day soon the IRIS Program will be able to produce high-quality, scientifically sound chemical assessments that are widely accepted by the scientific community, and I look forward to working with my colleagues to ensure this happens. Thank you, and I yield back. [The prepared statement of Mr. Marshall follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Chairwoman Sherrill. Thank you, Mr. Marshall. We are pleased to have the Full Committee Ranking Member, Mr. Lucas, with us today, so the Chair now recognizes the Ranking Member for an opening statement. Mr. Lucas. Thank you, Madam Chair, and thank you to all the witnesses for being here today to discuss EPA's IRIS Program. Over the last 10 years, numerous reports have been issued criticizing the IRIS Program for its lack of transparency, improper scientific processes, and ineffectiveness in addressing the needs of EPA regional and program offices. The flaws are well-documented. Current EPA leadership is taking positive steps to address these issues, and I laud their progress. However, we have yet to see a completed assessment of the IRIS Program that fully incorporates all of the recommendations made in the last decade. Unfortunately, that means there are numerous IRIS assessments in the database that are questionable, unreliable, and in some instances just plain incorrect. Take IRIS' assessment of ethylene oxide, which is used to sterilize medical equipment. In fact, some medical equipment can't be sterilized by any other chemical. In 2016, IRIS set an absurd risk value that is 19,000 times lower than the levels of this chemical that naturally occur in the human body. Assessments like this can have disastrous effects on the economy and human health if relied upon by government agencies in crafting regulation. Accordingly, today's hearing raises an important theme: How we characterize the chemicals in the environment. Unfortunately, there are too many government agencies, both national and international, that mischaracterize risk associated with chemicals. These agencies, just like the IRIS Program, have a history of identifying extremely conservative, even paranoid levels of exposure that can be classified as carcinogenic. Another program with a poor track record of assessing risk is the International Agency for Research on Cancer, IARC. Unlike IRIS, IARC's problems go beyond bad science. IARC is plagued by a severe lack of transparency and accountability, as well as significant conflicts of interest. But other parallels with IRIS exist. IARC assessments have led to the classification of things like red meat and coffee as being carcinogenic. States like California adopt these assessments at face value and slap a warning on every product imaginable. The public promptly ignores these warnings because they know coffee will not give them cancer. In the end, we are left with useless and ineffective regulations that only serve to waste taxpayer money. Although the IRIS Program does not have regulatory authority, it is important to note the consequences of when government agencies miscategorize risk. As I said, I'm pleased the current Administration is taking a thoughtful and meaningful look at how we characterize I should say, chemical risk. I'm hopeful these efforts will bear fruit. In the meantime, we will remain vigilant in ensuring that programs like IRIS are useful, transparent, and effective in meeting EPA's core mission of protecting human health and the environment. I yield back, Madam Chairwoman. Thank you. [The prepared statement of Mr. Lucas follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Chairwoman Sherrill. Thank you, Mr. Ranking Member. If there are Members who wish to submit additional opening statements, your statements will be added to the record at this point. [The prepared statement of Chairwoman Johnson follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Chairwoman Sherrill. At this time I would like to introduce the witnesses for our first panel: Dr. Jennifer Orme-Zavaleta, the Principal Deputy Assistant Administrator for Science with the Office of Research and Development and the Science Advisor for the Environmental Protection Agency, the EPA; and Mr. Alfredo Gomez, Director of the Natural Resources and Environment team with the Government Accountability Office, the GAO. Mr. Gomez is also the principal author of the March 2019 GAO report on the Integrated Risk Information System, IRIS, which is the basis of our hearing today. As our witnesses should know, you will each have 5 minutes for your spoken testimony. Your written testimony will be included in the record for the hearing. When you all have completed your spoken testimony, we will begin with the questions, and each Member will have 5 minutes to question the panel. We will start with Dr. Orme-Zavaleta. TESTIMONY OF DR. JENNIFER ORME-ZAVALETA, PRINCIPAL DEPUTY ASSISTANT ADMINISTRATOR FOR SCIENCE AND SCIENCE ADVISOR, OFFICE OF RESEARCH AND DEVELOPMENT, EPA Dr. Orme-Zavaleta. Thank you, and good morning, Chairwomen Fletcher and Sherrill, Ranking Members Marshall and Norman, and other distinguished Members of the two Subcommittees. My name is Jennifer Orme-Zavaleta, and I'm the Principal Deputy Assistant Administrator for Science in EPA's Office of Research and Development (ORD). I also act as the Agency's Science Advisor. My responsibility as the career lead for ORD is to ensure that we provide solid and robust science to inform Agency decisions. I have worked for EPA since 1981 in the areas of human health and ecological risk, research, policy development, strategic planning, and program implementation. Of these nearly 38 years, I've spent 26 in ORD, which is the parent office of the Integrated Risk Information System, commonly called IRIS. I appreciate the opportunity to talk with you today about IRIS. I was at EPA when IRIS was created, and I've seen it grow into the rigorous scientific program it is today. ORD's highly trained IRIS staff helped the program's regions, States, and others assess the risk of potential exposures to chemicals and nonchemical contaminants. IRIS assessments are a key part of this, providing the first two steps of the risk-assessment process: Hazard identification and dose-response assessment. This information informs risk assessments that are conducted by EPA programs, regions, States, and others, though some EPA programs conduct their own hazard and dose-response assessments. IRIS assessments provide a scientific foundation for decisionmaking under an array of environmental laws. The IRIS assessment process ensures transparency, scientific rigor, and provides opportunities for public, stakeholder intra- and interagency engagement. This process also includes robust independent scientific peer review. In 2011 and 2014, the National Academy of Sciences issued reports outlining recommendations to improve the IRIS Program by adopting systematic review, and this is known for transparency and scientific rigor. In 2017, IRIS began to implement systematic review across its assessments, and since then, IRIS has made assessment plans and protocols available to the public earlier in the assessment development process, providing more time to consider scientific complexities. In a report published in April 2018, the National Academies concluded that IRIS has made substantial progress. GAO has also provided input to improve the IRIS Program, which has included suggestions to increase timeliness, transparency, and process challenges. In a recent audit report, GAO found that IRIS has made improvements and has demonstrated the impacts of actions that we've taken. IRIS has made these improvements by incorporating project and program management by moving away from a one-size-fits-all assessment to a mixed portfolio of chemical evaluation products. In addition, IRIS has optimized systematic review software tools, which are increasing the efficiency and promoting greater transparency by making information more accessible to the public. With these changes, a large segment of the assessment portfolio can now be completed in 1 to 3 years instead of 3 to 10. The GAO report noted this, indicating that the preparation of several recent draft assessments has taken months, not years. To ensure that these new and improved processes are successful, IRIS has extensively trained its staff and is extending this training across the Agency and to the stakeholder community as well. Another major challenge--change in how IRIS operates is in how EPA programs request and prioritize IRIS assessments. Because IRIS assessments play such a critical role, the EPA Administrator requested a formal process signed off at the Assistant Administrator level, through which programs identify what IRIS assessments are a priority, when they are needed, and why they are needed. This process was completed in December and identified 11 priority chemicals. This formal process is a great improvement, as it brings further stability and responsiveness to the IRIS Program while also reinforcing accountability between the requesting program office and the IRIS Program. We will continue to conduct this process annually, though programs may nominate a new assessment at any time. Now that the prioritization process is complete, the public and stakeholders can expect to see IRIS assessments move forward. Last week, IRIS released a systematic review protocol for hexavalent chromium, and we plan to release other assessment materials soon. The formal prioritization process, along with the improvements in IRIS, has made--has helped us to address the NAS and GAO recommendations, and this will continue to make IRIS more efficient and a more effective program. We recognize that we still have work to do, but I am confident that as we move forward and address these open--we will address these open recommendations and concerns identified by the GAO. So thank you for the opportunity to appear before you today, and I look forward to answering your questions. [The prepared statement of Dr. Orme-Zavaleta follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Chairwoman Sherrill. Thank you, Dr. Orme-Zavaleta. And now, I would like to recognize Mr. Gomez for his testimony. TESTIMONY OF ALFREDO GOMEZ, DIRECTOR, NATURAL RESOURCES AND ENVIRONMENT, GOVERNMENT ACCOUNTABILITY OFFICE Mr. Gomez. Chairman--Chairwomen Sherrill and Fletcher, Ranking Members Norman and Marshall, and Members of the Subcommittees, good morning. I'm pleased to be here today to discuss our work on EPA's efforts to address toxic chemicals. As has been noted, EPA is responsible for reviewing chemicals in commerce and for those entering the marketplace. EPA's ability to effectively implement its mission of protecting public health and the environment depends on its credible and timely assessments of the risks posed by these chemicals. The Agency's Integrated Risk Information System program, which is under the Office of Research and Development, identifies and characterizes the health hazards of chemicals and produces human health toxicity assessments. EPA program and regional offices rely in part on these assessments to make risk management decisions. My statement today summarizes our March 2019 report on EPA's efforts to produce IRIS assessments. I will discuss the extent to which the IRIS Program has made progress in addressing identified challenges and in producing chemical assessments. And as has already been noted by the Committee, we also recently issued our High Risk update, which includes transforming EPA's process for assessing and controlling toxic chemicals. Just as a matter of background, I wanted to mention that the IRIS Program uses a seven-step process to produce assessments, so there's a lot of review that's built into the process. First, EPA has to determine the scope and the questions that the assessment will cover, and these are released for review and public comment. The draft assessment is then developed using systematic review. After the full draft is developed, it goes through agency review, interagency review, and external peer review and public comment. After staff make revisions to address the comments, the draft then goes through another round of internal and interagency review. Then the program finalizes and posts the assessments to the IRIS website. So historically, developing IRIS assessments has been a lengthy process and typically takes several years to complete. The IRIS Program has made progress addressing timeliness and transparency challenges in the assessment process. So, for example, the IRIS Program is now employing project management principles and specialized software to better plan assessments and utilize staff. In addition, the program has begun assessments that are more limited in scope and targeted to specific program and regional office needs. The IRIS Program has implemented systematic review, which provides a structured and transparent process for identifying relevant studies, reviewing their methodological strengths and weaknesses, and integrating these studies as part of weight-of- evidence analysis. In early 2018, EPA made progress on assessments that were in development. However, EPA leadership deliberations delay the release of some assessments by 6 months. So in June 2018, the Administrator's office told IRIS officials that they could not release any IRIS documentation without a formal request from EPA program office leadership. In August 2018, the Office of Research and Development asked program offices through a survey to reconfirm which of the 20 ongoing chemical assessments they needed. Several program offices responded confirming their needs for these assessments. Then in late October 2018, prior to releasing the results of the initial survey, these offices were asked to limit their chemical requests further to the top three or four assessments. EPA leadership did not provide them a reason for the limit or guidance on prioritizing assessments. Then finally in December 2018, as has been noted, EPA publicly issued its IRIS Work Plan, which provided an updated list of 13 assessments. Eleven of the 13 chemicals on the IRIS Work Plan were requested by two EPA program offices. The two remaining assessments were already at external peer review. EPA gave no indication of when additional assessments could be requested or what the IRIS Program's workflow would be in the future. While the program's work was delayed, EPA directed 28 of approximately IRIS staff to support implementation of TSCA with 25 to 50 percent of their time according to officials. It is unclear if this is a temporary workforce shift or if TSCA will require this level of support moving forward. So, Chairwomen Sherrill and Fletcher, Ranking Members Norman and Marshall, and Members of the Subcommittees, this concludes my statement. I'd be pleased to answer questions. [The prepared statement of Mr. Gomez follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Chairwoman Sherrill. Thank you, Mr. Gomez. At this point we will begin our first round of questions. The Chair recognizes herself for 5 minutes. First of all, Mr. Gomez, I want to commend you and your colleagues at the GAO on your thorough and meticulous work in the report that was published on March 4. The Subcommittee appreciates your efforts to help us better understand the status of the IRIS Program. Can you summarize the GAO's findings regarding the recent EPA's leadership decisions that hindered IRIS' ability to complete its toxicity assessments? Mr. Gomez. Maybe I can just provide another summary of the--as our audit documented, the steps. As I mentioned earlier, it started in August with ORD sending out a survey to all of the program offices to reconfirm whether the 20 ongoing assessments were still needed. And so offices then responded to that. In fact, there were three offices, program offices, that responded that they needed the majority of those assessments. In fact, it was the Office of Land and Emergency Management which requested that all 20 of those chemical assessments were needed. The Office of Water requested 15 of those, and the Office of Children's Health Protection requested 18. Also, the Office of Policy did confirm all of them. And as I also noted, then in October the--sorry, there was then--there was then a request in mid-October, a second time, for offices to reprioritize and to further reduce the number of assessments to three or four. Chairwoman Sherrill. And so you had mentioned also in releasing the reports that I believe it was August--it was in 2018. A new policy came out that you had to ask leadership to release the reports or get authorization---- Mr. Gomez. Yes, so essentially before an IRIS assessment could be issued, it had to be requested by an Assistant Administrator or even if you needed an assessment, that it needed to be at that level. Chairwoman Sherrill. OK. And before that, how did it work? Mr. Gomez. The IRIS officials, the offices would just work with the program offices at EPA and ask them what---- Chairwoman Sherrill. Determine---- Mr. Gomez [continuing]. They needed. Chairwoman Sherrill. And then we've been talking a bit about the 2011 National Academies' review of IRIS' draft formaldehyde assessment, and it identified areas for IRIS to improve. Much has changed since then, so can you also--and you spoke a little bit about timeliness and transparency, but can you also provide an overview of the progress that IRIS has made since 2011 in improving its assessment process? Mr. Gomez. Sure. So that's also something that we discussed in our High Risk update report where we lay out the areas in which--and I think it's been mentioned by a number of the Members of the Committee already that there are a number of areas in the IRIS Program where there have been improvements in terms of them using systematic review, in terms of them trying to improve the timeliness process, and so there have been a variety of areas that we covered in terms of building the capacity of the program, making sure that they have an action plan in place. And so those are the areas that we highlight, and we gave the program a rating of partially met in all of those areas because we do see a lot of progress. And, as has been noted, this is a program that historically has taken a long time to do chemical assessments, and so we see that there's a lot of improvement that's been taking place. Chairwoman Sherrill. And yet now some of the timeliness problems are because leadership is holding up the ability to release the assessments? Mr. Gomez. So, as we noted in our report, in that 6-month period, there was a delay while these deliberations were taking place, and so that's what we were calling attention to. Chairwoman Sherrill. And finally, can you detail the IRIS staff reassignments in support of the Toxic Substances Control Act that occurred in October 2018? Mr. Gomez. Sure. So as we noted in the report and as I noted in my statement, there--EPA directed 28 of their 30 IRIS staff to support implementation of TSCA, and they were providing anywhere from 25 to 50 percent of their time. Chairwoman Sherrill. Thank you very much. I will now recognize Mr. Norman for 5 minutes. Mr. Norman. Thank you, Chairwoman Sherrill. In the 2014 report, the National Academy of Sciences specifically recommended that EPA finalize and release a handbook that outlines the IRIS assessment evaluation process. This recommendation was reiterated in 2018. The NAS evaluation of IRIS which stated that the EPA would complete the handbook in 2018. Mr. Gomez, in preparing the recent reports, was the GAO provided a copy of the IRIS handbook? Mr. Gomez. Yes, we have it. It's a draft copy because it has not been finalized yet. And that is something that we are also tracking, and so we've been looking to see when EPA is going to release that. Mr. Norman. OK. Dr. Orme-Zavaleta, have you reviewed the IRIS handbook? Dr. Orme-Zavaleta. And please feel free to call me Jennifer. Mr. Norman. I'll call you doctor. Dr. Orme-Zavaleta. I know my name's a mouthful. So we have a draft IRIS handbook that has gone through Agency review; it was initiated last summer. We received comments all the way through to December. We had our 5-week hiatus with the shutdown. We are still in the process of addressing some of the comments that came in and will continue to work toward completing that document. Mr. Norman. When will it be ready for publication in your opinion? Dr. Orme-Zavaleta. So we're--conversations with some of the commenters are still ongoing. Some of the questions are not as easily identified, and in my opinion was going to extend into a broader conversation across the Agency, so we'll have to see how we can complete the document. And for those issues that need further work, what will be the process for addressing those. Mr. Norman. Can you identify this morning what the hold up is exactly, and I guess when it will be completed with where you are, where you see it? Dr. Orme-Zavaleta. So some of the conversation is around how we evaluate hazard and how we identify or categorize areas of hazard, and these are conversations that involve more than one office, and so this is something that I'm looking to engage other parts of the Agency through our risk assessment forum to address whether that holds up this document or not. I think that's something that we still have to determine. So my hope is that we complete this soon, but this is a process that we are continuing. I've raised with the Administrator, and hopefully, we'll have a path forward on how to address. Mr. Norman. Well, I mean, in my world--I mean, I'm a real estate developer. I look on a handbook as a blueprint to go by on projects. If you don't have a handbook, you really can't move forward. And the excuses I've heard--am I right? It hasn't been completed in 8 years? Dr. Orme-Zavaleta. What hasn't been completed in 8 years? Mr. Norman. The handbook. Dr. Orme-Zavaleta. So I don't know when the handbook was initiated. I came into this role over this past year. But elements of the handbook are being captured in some of our systematic review protocols, and those documents are moving forward. So the document we just released last week on hexavalent chromium incorporates elements of that handbook. So we are utilizing that blueprint, and we're able to move forward on our assessments. The particular handbook is an internal guide for us, and just completion of that is something that we're still working through comments. Mr. Norman. But it's very important to have the handbook-- -- Dr. Orme-Zavaleta. Absolutely. Mr. Norman [continuing]. As a guide so you can adequately move forward. Dr. Orme-Zavaleta. And we are utilizing that internally and running it through our assessment so that we keep those assessments moving. Mr. Norman. Thank you. Mr. Gomez, the GAO has reviewed the IRIS Program over many years and multiple Administrations. In the GAO's review of the IRIS Program, has it found that the IRIS Program has regularly produced timely assessments for you all? Mr. Gomez. No, sir. One of the findings is that it takes a long time, many years, to produce assessments, and so, as has been noted and discussed, we and the National Academies have made recommendations to improve the timeliness of those assessments. Mr. Norman. Well, with that, then, do you think the IRIS Program should remain high on the GAO's High-Risk List? Mr. Gomez. So we--we have it on a High-Risk List because we do see that it needs improvement to produce those assessments that are needed by other EPA program offices and folks outside of EPA, so until we see demonstrated progress in the program, it's going to remain on the list, yes. Mr. Norman. Well, I would stress the importance of getting it in. In my world we're on penalties if we don't make something in a timely response. I can't just say to our tenants, you know, we're trying. It gives you an ending and a beginning date. Eight years to me is out of the question. Thank you all so much. Chairwoman Sherrill. Thank you. I now recognize Chairwoman Fletcher for 5 minutes. Mrs. Fletcher. Thank you, Madam Chairwoman. Thank you to the witnesses this morning. Your testimony has been helpful. My first question is directed at Dr. Orme-Zavaleta. According to the EPA, the role of the Office of Science Advisor, or OSA, is to provide leadership on science and technology issues and policy to facilitate the integration of the highest quality science into the Agency's policies and decisions. As the current acting EPA Science Advisor can you discuss the OSA's role in EPA's strengthening transparency in regulatory science proposed rule? Was the OSA consulted during the drafting of this proposed rule before it was submitted to the Federal Register? Dr. Orme-Zavaleta. So the answer to that is no. The science--the STPC (Science and Technology Policy Council) was given a briefing once the proposal was out and has been aware of the next steps. The Agency received a number of comments. We're still going through and synthesizing those comments, and then we'll determine our next steps forward. Mrs. Fletcher. OK. And on a related note, the EPA ostensibly bases its environmental and public health protection regulations on robust science. How often do you engage with regulatory program offices within the Agency and provide scientific input on new regulatory actions? For example, how often are you consulted on the Agency's deregulatory actions? Dr. Orme-Zavaleta. So the--in the regulatory process, the Agency establishes an ADP (Action Development Process) workgroup, which is a--I don't remember the specific acronym, but it engages representatives across the Agency and is overseen by the lead office with the particular regulatory action. So our office and our staff are engaged when they have these workgroups formed and working through the different regulatory efforts. Mrs. Fletcher. How often do you meet with Administrator Wheeler to provide scientific input into decisionmaking at the highest levels of the EPA? Dr. Orme-Zavaleta. So I have a regular monthly meeting with the Administrator. I also see him weekly for--he meets with our--the senior leadership across the Agency. And then if there are specific rulemaking activities or issues to be addressed and there will be a meeting convened for briefing and either I or my staff will be involved in those discussions. Mrs. Fletcher. And how often did you or your predecessor meet with Administrator Pruitt for the same purpose? Dr. Orme-Zavaleta. So less. Each Administrator has their own style and approach, and with Administrator Pruitt he participated in senior staff meetings periodically, but I did not have an opportunity to meet with him as a representative of ORD. Mrs. Fletcher. Thank you, Dr. Orme-Zavaleta. One other question relating to the GAO report is the GAO found that by October 2018 that more than 90 percent of IRIS staff were spending up to half their time supporting risk evaluation under TSCA, is that correct? And so---- Mr. Gomez. That is correct, yes. Mrs. Fletcher. OK. So, Dr. Orme-Zavaleta, since Congress has clearly expressed its intent that the IRIS Program remain within ORD, how could EPA justify diverting staff hired for the sake of implementing IRIS to other program offices within the Agency? Dr. Orme-Zavaleta. So just to be clear, the staff remained in ORD, and within the Agency, ORD is a partner with a number of our program offices working through different scientific issues, whether it's helping with implementation of TSCA or working with the Office of Water on some of their science issues or OLEM (Office of Land and Emergency Management) or others. So we take a one-EPA approach in leveraging the expertise and experience across the Agency for the different types of scientific disciplines. Some offices may not have as many types of scientists that ORD has, and so we work with them collaboratively in trying to sort through these different issues. Mrs. Fletcher. OK. And I want to follow up on one other question that one of my colleagues asked about the publication of the IRIS handbook. I know that we've already discussed it a little bit, but can you give us any insight into what has caused the delays in its publication? Dr. Orme-Zavaleta. So, again, we submitted the handbook for Agency review toward the end of last summer. We had comments come in through the course of the fall, some as late as December, and then with the shutdown that set us behind, so we are doing catch up and we are working through some of the issues that have been raised. Mrs. Fletcher. OK. Thank you. I yield back the remainder of my time. Chairwoman Sherrill. Thank you. The Chair now recognizes Representative Biggs. Mr. Biggs. Thank you, Madam Chair, and thank you, panelists, for being here today. I think it's no secret to anybody who's watched my performance on this Committee that I've been a longtime critic of the IRIS Program. In the last Congress, while serving as the Chairman of the Environment Subcommittee, I sponsored legislation to effectively eliminate IRIS in its current form and return chemical assessments to the appropriate program offices of EPA. That bill, the Improving Science in Chemical Assessments Act, was voted out of the full SST Committee last July. I've reintroduced this bill the current Congress, but I doubt for some reason that it'll be reported out of this Committee again anytime soon. And I'm disappointed with that of course, that the chemical assessments process at EPA has not received a complete structural overhaul despite years' and years' worth of criticism and observations by the NAS and GAO. That said, apparently, there have been few glimmers of hope at EPA over the last couple of years, and I'm happy about that, but clearly, there are at least some high-level officials at the Agency who generally believe that: One, chemical assessments should rely on good, transparent, publicly available science, and that's true. And two, chemical assessments should be carefully tailored to serve program and regional office needs, and I'm happy about that. And I want to hear more from your perspective, Mr. Gomez. The most recent GAO report on the IRIS Program reiterates yet again that EPA should develop an action plan that, among other reforms, places primary responsibility for chemical assessments in the relevant program offices. Is that a fair characterization? Mr. Gomez. No, sir. Mr. Biggs. Please state how would you characterize it? Mr. Gomez. So, the way IRIS came about, it was because there were many different program offices doing their own chemical assessments, sometimes different values were generated, and so this was an effort to centralize and to come up with Agency consensus on these assessments. And I'm sure that Jennifer can also talk about that history and evolution of the IRIS Program. So that is our understanding of it. And our reports on the High-Risk List on IRIS are looking to improve the IRIS Program to make it more timely, to make it more transparent, as you said, so that it is using the best available studies that are out there, and it's going through the proper levels of review both internal and external peer review. Mr. Biggs. Well, can you explain why the EPA leadership has been criticized for beginning to do what GAO has been requesting? Mr. Gomez. So and--again, in our current report we focus on--we do talk about the progress that EPA is making, which we've been chatting about, but we also talk about other challenges that the program is facing. And so we were drawing attention to the delays in issuing the assessments. As we've said, these assessments take a long time, sometimes years to do, so that's what we've been focusing on. And there is a lot of progress, and we do note that in the ratings that we do for the IRIS Program, but yet there's still challenges ahead. Mr. Biggs. Well, one of the interesting pieces of testimony that I'm taking from this today, is this notion of the handbook, the handbook that may have been ordered 8 years ago, recommended 8 years ago, certainly recommended 4 years ago, and yet I think it just takes a lot of moxie to come in here today and say, well, the reason we don't have this done is because we had a 35-day government shutdown this year. That's incredible moxie and doesn't get at the heart of this, but I think it does get at the heart of what the ultimate problem with IRIS is, and that is a bogged-down bureaucratic system that needs to be streamlined and fixed. And I hope that you take that into consideration. It's meant as positive feedback. I hope that it's criticism that requires and produces some real self- evaluation because I'm still disappointed at the IRIS Program, and I'm disappointed at the almost glacial pace that we see in change in that program. I yield back. Chairwoman Sherrill. Thank you. I'd now like to recognize Representative Bonamici for 5 minutes. Ms. Bonamici. Thank you very much. Thanks to the Chairs and Ranking Members and to our witnesses. The Environmental Protection Agency should rely on the best available independent science to inform Federal policy, and the EPA mandate is to protect public health and the environment, and that can only be achieved if the EPA is acting on the basis of science that's independently verifiable and free from political influence, bias from ideology and conflicts of interest, and that certainly includes credible assessments of the risks posed by chemicals. And I've been on this Committee for about 7 years now and of course have sat in many hearings, as have many of my colleagues, about IRIS over the years. There's no question that there is a need for improvement, but what I am hearing today and what I am seeing in the recent GAO report I do not consider improvement. The EPA's Integrated Risk Management System, or IRIS, remains distinct from the regulatory programs of the EPA intentionally. It's striking that the EPA would consider moving away from the robust science and preventing IRIS from disclosing its findings to the public. Continued efforts to sideline science from the policymaking process at the EPA will have chilling consequences for every person in this country who benefits from clean air and water and particularly and disproportionately young children, seniors, and the health- impaired. Mr. Gomez, in the March 4 GAO report entitled ``Chemical Assessment Status of EPA's Efforts to Produce Assessments and Implement the Toxic Substances Control Act,'' it outlines that in June 2018 EPA leadership in the Office of Research and Development instructed the IRIS Program to not release an assessment without a formal request from the current leadership of a program office. And then ORD instructed the IRIS Program to not publicly release any assessment documentation for public comment, agency, or peer review while the responses to a survey of program and regional offices needs were being compiled. And the list then of that--so it's 20 assessments was then reduced to three or four chemicals. I'm obviously concerned. David Dunlap, a former Koch Industries lobbyist, now serves as a Deputy Assistant Administrator for Research and Development. These findings of the increased role of ORD in the IRIS assessment processes are very concerning. So, Mr. Gomez, prior to June 2018, had political leadership at ORD ever limited the release of IRIS assessments? Mr. Gomez. That is not our understanding. Ms. Bonamici. Did the GAO find any other changes to the seven-step process that IRIS uses to complete toxicity assessments? Mr. Gomez. No, we are not aware of any changes at this point. Ms. Bonamici. Thank you. I want to point out there's just a section in the GAO report, page 25, that talks about the calls for advice from program office officials represented the first time the IRIS Program heard about requests for a prioritized list according to the IRIS Program officials since neither the program and regional offices nor the IRIS Program had information from the Administrator's office about what the prioritization was meant to achieve. The IRIS Program was unable to provide guidance about what chemicals may be considered a priority or how they might be able to continue to work on. And then the reduction with no apparent reason, those things are documented in the GAO report, very concerning. Dr. Orme-Zavaleta, it's my understanding that you oversaw the August 2018 survey of program and regional office needs for 20 assessments. Did you and any other career staff at ORD and IRIS have any role during the second round of survey in October? Dr. Orme-Zavaleta. So once we received some initial responses from the programs in response to the August memo, there was a conversation the Administrator had with his leadership where there was conversation about further prioritizing. There was concern that the number of responses that came back, which was around 50 or so chemical requests, was too large. Ms. Bonamici. And what was the basis--did--was that explained? What does too large mean? Dr. Orme-Zavaleta. I wasn't involved in those discussions, so I can't say. Ms. Bonamici. Did you ever see the findings from the first survey, and are they publicly available? Dr. Orme-Zavaleta. So I did receive memos from the response of the survey from each of the program offices that responded, so yes, I have those, and I believe GAO received those from some of them. Ms. Bonamici. And the second survey from what I can tell from the GAO report was fairly informal, maybe even verbally sent. What factors determine the chemicals that were selected as priorities from the second survey? Dr. Orme-Zavaleta. So for the second survey there was a template that was returned back to me that was signed off by the Assistant Administrator for those offices. And, again, they were asked to respond what were their needs, how are they to be used, and when were they needed, and so that was the information that was provided back to me, and that included 11 compounds. Ms. Bonamici. My time is expired. I yield back. Thank you, Madam Chair. Chairwoman Sherrill. Thank you. And now the Chair yields 5 minutes to Dr. Marshall. Mr. Marshall. Thank you so much, Chairwoman. I think all my questions are directed to Dr. Orme-Zavaleta, so thank you so much for being here. Does IRIS assessment include any consideration of actual human exposure or making any determination of actual human risk? Dr. Orme-Zavaleta. So the--as noted earlier, the IRIS Program involves the first two steps of the risk assessment process, so it focuses on hazard and then dose response. That provides that scientific foundation, which then moves to a program office, and their program offices will apply other statutory considerations for the programs they implement that include exposure and risk characterization. Mr. Marshall. I would suppose when you were doing your studies--you have four or five studies going at a time on one particular substance? Dr. Orme-Zavaleta. So in looking at hazard and dose response, we look at all available literature that is available for that particular chemical, and that can include animal information, human information. This is where our systematic review process comes into play where it helps to organize and synthesize that---- Mr. Marshall. What do you do when there's conflicting data, which I see all the time as a physician. I'll see 20 studies on a particular issue and there's usually lots of conflict between the studies that I'll read. Dr. Orme-Zavaleta. There's a lot of conversation, there's a lot of judgment that's employed in going through these evaluations, and that's why it's so critical that we have the levels of review that we have. So as we look through all of the information available in making determinations and judgments about hazard and dose response that forms those toxicity---- Mr. Marshall. And do you share with others, here's the studies we looked at and this is why we chose this one over that one---- Dr. Orme-Zavaleta. Yes. Mr. Marshall [continuing]. So that's a transparent process? Dr. Orme-Zavaleta. Absolutely. Mr. Marshall. OK. It looks like to me that sometimes IRIS assessments set levels for a chemical below levels that are found naturally in the environment, which little Kansas common sense to me that doesn't make sense. Do you agree that sometimes you set numbers down that are lower than naturally occurring in the environment? Dr. Orme-Zavaleta. So depending on the chemical and what information is available--and so I don't know if you have a specific compound in mind, but we'll look at all of the available information, and that will feed into our dose- response assessments that could give a risk level that incorporates various levels of uncertainty as well. Mr. Marshall. So if we're sitting in this room and we were packed here together and whether it's ethylene oxide or formaldehyde, whichever one it is, if you're setting levels lower than what we measure--do you ever measure what's just commonly occurring in the environment and--it just doesn't make sense to me. Dr. Orme-Zavaleta. So the measurement information is not part of the hazard dose-response evaluation. That's what comes in with the program offices in looking at exposure and determining what the final risk assessment will be. Keep in mind IRIS just provides the hazard and dose response and will give us a level--a toxicity level for either a cancer or a noncancer. Then that goes to a program office who will complete the risk assessment process by factoring in exposure and risk characterization information and then moves into that regulatory context. Mr. Marshall. So, you know, as a scientist, do you think it would be OK to set a hazard level lower than what occurs naturally in the environment at times? Dr. Orme-Zavaleta. It's going to be data-driven, and it's not going to be done in an ad-hoc way. These assessments go through rigorous review within the Agency, between Federal agencies. Mr. Marshall. Right. Dr. Orme-Zavaleta. It opens up for public comment. It goes through a rigorous external peer review. And then, as Mr. Gomez noted, once we come through and incorporate those comments, it goes back through another round of review within the Agency and between agencies. Mr. Marshall. You know, as a physician, I have to take lots of data but eventually have to take some common sense every once in a while as well. When I see a study that just makes no sense at all to me and they come to a conclusion that I do an experiment on that particular medication or treatment plan with my patients, so I do hope there's some common sense every once in a while. Are IRIS assessment cancer classifications representative of actual human health risk? Dr. Orme-Zavaleta. I'm sorry, can you clarify---- Mr. Marshall. Yes. Dr. Orme-Zavaleta [continuing]. That again? Mr. Marshall. Yes. Are IRIS assessment cancer classifications representative of actual human health risk? Dr. Orme-Zavaleta. So the Agency has cancer risk assessment guidelines, and those were last developed in 2005, and that lays out different levels of carcinogenicity classification based on available information, so--that will include whatever information we have from human data as well as animal data or other supporting data, and those go into those cancer classifications. Mr. Marshall. OK. Thank you. And I yield back. Chairwoman Sherrill. Thank you. And now the Chair recognizes Representative Tonko. Mr. Tonko. Thank you to the Chairs and Ranking Members for an important hearing. The process--or processes through which science is conducted, reviewed, or communicated to the public and incorporated into policymaking must be transparent. It must be free from inappropriate political, ideological, and financial and other undue influence. We have seen a disturbing trend at EPA lately where science is being sidelined. I'm extremely concerned by the actions that have suppressed information and kept results hidden from the general public. I am also disappointed by recent efforts to hurt the IRIS Program. The IRIS Program has reviewed hundreds of chemicals and supports programs across our entire Agency. This is an important program that keeps us safe. We should not be gutting it. We should be ensuring that it has the resources and staff to thrive and continue to provide for toxicity information. Instead, some here in Congress and in the Administration want to give an even louder voice to industry interests that would replace unbiased expertise. This would hurt public health and is a dangerous endeavor. EPA's priority must be to protect public health and our environment. So, Dr. Orme-Zavaleta, according to GAO, the Office of Children's Health Protection, or OCHP, submitted a lengthy set of priority chemicals for the first round of the IRIS survey but did not see any of its priorities reflected in the December program outlook due to its lack of response during the second round. OCHP is a critical EPA office that focuses on the unique vulnerabilities facing children from environmental dangers. Our children's health should always be a priority, top priority for EPA. So my question is, was OCHP asked to participate in the second round of the IRIS survey along with the other program offices? Dr. Orme-Zavaleta. They did receive that information to participate in the second round and in fact did submit their priorities, but it came in after the list and December memo had been finalized. You know, that said, as we noted in our process, an office can identify or nominate a new assessment need at any time, and we'll have another formal round of requests coming later this summer. Mr. Tonko. Can you explain the timing? And was it a coincidence that OCHP submitted its list precisely when it was too late to include them? Dr. Orme-Zavaleta. So I was not involved in the further, the second phase of that prioritization process. I'm not aware of what particular timeframe was identified. Again, I was informed of here was the list and then I released memos and---- Mr. Tonko. But there was no--no one shared a prior history with you about---- Dr. Orme-Zavaleta. I was not involved in those conversations. Mr. Tonko. What chemicals did OCHP include on its second round priority list of three to four chemicals? And was formaldehyde one of those chemicals? Dr. Orme-Zavaleta. I believe formaldehyde was one of those chemicals, but we can get back with you. I don't recall the full list. Mr. Tonko. And does ORD consider the protection of children's health a priority? And if so, why did it not make more of an effort to include OCHP's request in the final list of IRIS chemicals? Dr. Orme-Zavaleta. So we consider--so we are a supplier of science to the Agency's programs that use that information, and so as far as children's health programs, yes, we do consider it vitally important, and we help to sponsor some research at the children's health centers, along with NIEHS. Again, with the particular process I was not involved in that and did not receive the final input until early December. Mr. Tonko. Can you imagine how they could have made more of an effort to include OCHP's request? Dr. Orme-Zavaleta. I think that's something that we can think about going forward. Mr. Tonko. But nothing constructive that you would offer this panel today? Dr. Orme-Zavaleta. No, not at this point. Mr. Tonko. Mr. Gomez, GAO's findings reveal a disturbing level of political interference with IRIS. If political appointees inside EPA are excluding the EPA career staff from key decisions, it raises a host of concerns about whether those appointees can be trusted to do the right thing for IRIS and the public. Was GAO able to determine who inside EPA made the decision to conduct a second round of the IRIS priority survey? And who decided to limit that round to three to four chemicals per program office? Mr. Gomez. So that's something we do not have clear information on, so as we reported it was our understanding that something was done early to limit them, but we don't know. What we do know, though, is that we do have responses from some of the offices that did submit it in the second round saying these are our three and four chemicals. Mr. Tonko. OK. I am out of time, so I will yield back, Madam Chair. Chairwoman Sherrill. Thank you. The Chair now recognizes Representative Bird--Baird, sorry. Mr. Baird. Thank you, Madam Chair. I appreciate the witnesses being here today. My question really goes to Dr. Orme-Zavaleta, and that has to do with the fact that Mr. Gomez mentioned a seven-step process for chemical assessment development recognition, and so in that process there's a draft of IRIS assessments, and they're circulated internal to the EPA and to the region for review. So how are those comments and concerns resolved? And then once they've been submitted for review, then how do they resolve those concerns and questions? Dr. Orme-Zavaleta. So the IRIS Program has regular communications with program and regional representatives. I think they may meet even monthly. And as comments and questions come in, there are conversations with the full group to sort through and resolve those particular comments, and then that moves onto the next phase. Mr. Baird. So I guess you're saying as those come in, if they're valid and reviewed, then they are incorporated in with the process and---- Dr. Orme-Zavaleta. And there is a conversation between the IRIS staff and the program representatives, as well as regional representatives on addressing those comments. Mr. Baird. A second part of that question, I understand the interagency science review formally was coordinated by the OMB (Office of Management and Budget), but how is that review currently coordinated? Dr. Orme-Zavaleta. The interagency science review process was revised in 2009 to be entirely managed and coordinated by EPA. OMB is a participant in the interagency science review process, along with other agencies and White House offices. Mr. Baird. OMB? OK. Mr. Gomez, I have a couple of questions for you. It was noted that the IRIS officials have implemented systematic review. Do we have any current documentation that would suggest guidance on how this systematic review takes place on this process? Mr. Gomez. So--and this is also something that Dr. Orme- Zavaleta can elaborate on. But systematic review is something that's been in place in EPA for a while. They have started also to use the software that allows them actually to do this faster. So, yes, we are aware that this is something that the IRIS Program is using. It is something that--that's good. In fact, I think maybe on your second panel there's someone that is even an expert on systematic review or knows a lot more about it. Mr. Baird. Thank you. One more question in that regard. To your knowledge, what specific IRIS assessments completed since 2014 have demonstrated full of implementation of the EPA IRIS system review process, any idea? Mr. Gomez. So, I'm sorry, you're asking how many have been released and went through the whole process? Mr. Baird. And completed the whole process---- Mr. Gomez. Yes. Mr. Baird [continuing]. Since 2014. Mr. Gomez. Perhaps Dr. Orme-Zavaleta might know. I don't think there's been many. I think there was one that was released recently. Dr. Orme-Zavaleta. While RDX was released recently (August, 2018) it does not represent full implementation of the IRIS systematic review process. Because the assessment was already in development when the 2011 NAS recommendations were released, the final assessment reflects early implementation in the programmatic adoption of the NRC recommendations. Mr. Baird. Thank you, and I yield back my time. Chairwoman Sherrill. Thank you, Mr. Baird. The Chair now recognizes Representative McAdams. Mr. McAdams. Thank you, Madam Chair. I have a question for Dr. Orme-Zavaleta. Press reports and Senate testimony from then-EPA Administrator Scott Pruitt indicate that the IRIS formaldehyde assessment has been ready for public release since 2017, since the end of 2017, and that the assessment establishes a link between formaldehyde exposure and leukemia. Formaldehyde did not appear on the December 2018 list of IRIS priority chemicals, and the GAO report indicated that its future is unknown. So my question is what is the status of the formaldehyde assessment, and when can we expect it to be released for public comment? Dr. Orme-Zavaleta. So we do have a draft formaldehyde assessment, and with TSCA recently announcing that formaldehyde is in their top 20, we're going to be having conversations with our Office of Chemical Safety and Inclusion Prevention to determine next steps in going forward. We feel that the assessment that we have will be--will help with that TSCA determination, and we need to determine next steps for supporting the other Agency needs. Mr. McAdams. So along those lines, why was the formaldehyde--why was formaldehyde left off the list of--the new list of IRIS priority chemicals, and who made that decision to leave it off? Dr. Orme-Zavaleta. So each program office made their decisions on what were their priorities, how they were going to use it, and when they needed it, and so I wasn't involved in those conversations. Again, the programs help provide the priorities, and then our responsibility is implementing those priorities and providing the best science available. Mr. McAdams. So who would've made the decision to not include formaldehyde on that list? Dr. Orme-Zavaleta. So that was through the program offices, and the requests that I received were signed off at the Assistant Administrator level. Mr. McAdams. So--and just last week EPA announced that it would designate formaldehyde a high-priority chemical under the Toxic Substances Control Act. How can formaldehyde be simultaneously a high-priority chemical under TSCA and not a priority at all for IRIS? Dr. Orme-Zavaleta. So I wouldn't say that it's not a priority for IRIS. We have not discontinued that work, and that information is going to be leveraged in helping to support TSCA moving forward, but there's going to be more conversations to follow on our next steps. Mr. McAdams. Thank you. One question for Mr. Gomez. Can you explain what you meant when you wrote in your testimony that the absence of the formaldehyde assessment, quote, ``could create confusion for stakeholders?'' Mr. Gomez. Right, so I think that there are stakeholders that were expecting to see that assessment and may in fact have use for it, and so now that it's not on the final list, I think there are questions about what happened to it, as you were asking, and where--when is it going to be released. Mr. McAdams. All right. Thank you. I yield back. Chairwoman Sherrill. Thank you, Mr. McAdams. Now, the Chair recognizes Representative Babin. Mr. Babin. Sure, thank you. Thank you, Madam Chair. Mr. Gomez, in your review of the IRIS Program, you rely in part on the 2018 NAS report to find that the IRIS Program has made significant progress. This 2018 NAS review was simply, if I understand it, a check-the-box exercise organized by career program officials confirming that changes have been made to the program. In other words, the NAS review did not examine any IRIS products to ensure proper scientific rigor. It did not identify any tangible outcomes as a result of the changes made to the program. Did GAO identify any of these shortcomings after using the 2018 NAS review as a primary source for praise of the program? Mr. Gomez. So perhaps what I can do is just explain the approach that we take in looking at the progress that the IRIS Program is making. So while we do look at other reports that are out there like the NAS study that you mentioned, we're looking at a couple of criteria, so we're looking at whether there is leadership commitment, you know, does the program have the capacity to do the work, do they have a plan in place to do the work, are they monitoring how well they're doing, and are they also demonstrating progress? So we look at all of those elements to then come up with a rating, and for the IRIS Program in particular, as we've been discussing, they have made some progress, so we are giving them the rating of partially met, so they're not fully met, and that is why it's still on the High-Risk List for GAO, and we're continuing to look at it. But we are concerned, as others, about the length of time that it takes to issue these assessments, and so timeliness is an area that has a lot of attention. Mr. Babin. OK. Thank you. And then, Dr. Orme-Zavaleta, I see the Administration has taken steps to prioritize chemicals for assessment in the IRIS Program. Would you classify this as a positive step for IRIS? Dr. Orme-Zavaleta. I do. I think we have always gone out to programs in helping to identify what their needs are, but this new process raises it to the Assistant Administrator level, and that's going to help provide greater stability to the program, as well as greater accountability not only to the program offices and reminding them that they made this request but also in helping us in meeting those particular requests. Mr. Babin. OK. Thank you, and I yield back, Madam Chair. Chairwoman Sherrill. Thank you. The Chair now recognizes Representative Beyer. Mr. Beyer. Thank you, Madam Chair. Mr. Gomez, one of the main concerns I have reading the GAO report is that, you know, the IRIS, which we've talked about for many years on this Committee, is just far too important to allow chemical assessments to be decided by anything short of a transparent, collaborative process that listens to the voices of the career staff. So in reading the GAO report, you talked about how the ORD's second request is made verbally at a meeting, including direction to the program offices to limit their request to no more than three to four chemicals. Did ORD explain to you why it was appropriate to do this directive verbally and with no prior consultation and not through a documented process? Mr. Gomez. No, sir, we don't have any additional information as to any additional guidance that was provided as to how they should further limit those assessments. Mr. Beyer. OK. And then, Dr. Orme-Zavaleta, I know you've read all this carefully. Does it make any sense to you that ORD proceeded to a second round of the survey with no involvement from IRIS leadership? Dr. Orme-Zavaleta. So the conversation that took place was a meeting that the Administrator has weekly with his senior leadership, the Assistant Administrators, and so I was not there, I was not involved in that particular conversation. I don't know how the request was made. I don't know the conversation that ensued. Mr. Beyer. Mr.--thank you. Mr. Gomez, did GAO--you know, we talked a lot about how the shrinking from 22 subject chemicals down to 11, and this is part of the prioritization process. Was there any evidence that IRIS was incapable of handling the previous largest--larger workflow? Mr. Gomez. As we understand it, the IRIS Program was able to handle that workload given their current resources. Mr. Beyer. And we certainly heard from--based on the questions from any of the other people on the panel that there were chemicals left out of that. Dr. Orme-Zavaleta, and again, I know this wasn't in your decisionmaking, but when did ORD decide to reduce the number of priority chemicals by so much? And, you know, one of the criticisms again that shows up in the GAO report was there was--there's no information at the EPA Administrator's office about what the prioritization was meant to achieve. Dr. Orme-Zavaleta. So, again, I wasn't involved in that conversation. I don't know that it was requested by the ORD representative or by the Administrator. Mr. Beyer. You know, the suspicious part of me wonders if the prioritization wasn't simply used as a way to eliminate chemicals that are controversial within industry and focus on ones that are easy, low-hanging fruit, for example, formaldehyde, which raises the prospect that this is not science driving it but rather politics and money, so---- Dr. Orme-Zavaleta. So, again, I wasn't there, but if you'd like further information, we can go back to staff and respond back. Mr. Beyer. OK. Great. Thank you very much. Mr.--Madam Chair, I yield back. Chairwoman Sherrill. Thank you. The Chair now recognizes Dr. Foster. Mr. Foster. Thank you. I appreciate it, and I appreciate being allowed to serve on this--in this hearing, although I don't actually serve on the Committee. I'd like to bring up the issue of ethylene oxide. Willowbrook, Illinois, in my district is home to a sterilization facility that's used ethylene oxide for decades to sterilize medical equipment. And this community has unfortunately become an example of the important role that the EPA plays in defending public health and what can happen when these systems don't do as well as they should. In the case of ethylene oxide, there was roughly a 15-year gap between the publication of scientific papers that indicated ethylene oxide was a far more powerful carcinogen than had previously been assumed and the corrective actions and eventual shutdown of that facility in my district that was venting apparently unsafe amounts of ethylene oxide into nearby neighborhoods. And I request unanimous consent to insert into the record the Executive Summary of the EPA's Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide into the record. Chairwoman Sherrill. Without objection. Mr. Foster. Thank you. And so Dr.--oh, boy--Orme-Zavaleta-- -- Dr. Orme-Zavaleta. Jennifer. Mr. Foster. Jennifer, you know, what would the reasons have been for a 15-year delay in the scientific findings and the actual actions? You know, are these things limited by just a shortage of manpower? You've got tens of thousands of chemicals and you have to prioritize your effort and you just don't have enough people on this, or is this a situation where there's a lot of pressure from industry that's delaying--causing a 15- year delay of this kind? Dr. Orme-Zavaleta. Yes, so I'm not exactly clear on--you're thinking of the timeframe. IRIS provided an assessment for ethylene oxide in 2016. Mr. Foster. Correct. And all the references in that were scientific papers dating from the late 1990s, early 2000s. Dr. Orme-Zavaleta. So, you know, I think that that's something I can take back to staff and we can get further information on how additional information can be incorporated, but the assessment that was published in 2016 went through-- it's a very complex chemical, a lot of intricacies in trying to evaluate those risks. Mr. Foster. Simple chemical but with complex biological effects. Dr. Orme-Zavaleta. There you go. And so in going through the reviews, it went through two rounds of review with our Scientific Advisory Board, which is not always common, but a very rigorous, thorough review, as well as reviewed through the different Federal agencies and within EPA, so it's a very solid assessment, and it's one that we continue to support, and that's part of our responsibility---- Mr. Foster. I understand. It just would have been nice if it would have been faster---- Dr. Orme-Zavaleta. Yes. Mr. Foster [continuing]. Than 15 years. And I was just wondering if this is a--I guess the point of my question is if this is a manpower-limited thing, then I think there is an argument to be made to just increase the manpower available so this situation doesn't happen because you can mess up either way. You know, there are people panicked selling their houses, and if it turns out the best scientific indications are that is unnecessary, then, you know, mistakes have been made in that direction. And of course there's the danger of damage to human health. And so if you could actually have a look at that specific case and see to what extent if you had--were not manpower limited---- Dr. Orme-Zavaleta. Yes, we'll be glad to follow up. Mr. Foster [continuing]. Whether--what that timescale could have been compressed to be. Dr. Orme-Zavaleta. Sure. Mr. Foster. And also if you could come up with a best estimate of the number of people, you know, who will--you know, assuming that the report stays valid, a best estimate of the number of people, additional cancer cases nationwide due to that delay and particularly the avoidable part that might be avoided with more investment in manpower. And just more generally does the EPA or any third party maintain estimates of the cumulative number of lives saved by EPA actions? Dr. Orme-Zavaleta. So I think that's something I'll also have to follow up on. There are evaluations that are not necessarily conducted within ORD but other parts of the agency that looks at impact analyses, and so that's something we can follow up on. Mr. Foster. Yes. It would be a very good thing to do. Also, the cumulative costs because your actions impose costs on industry, and they save human lives, and seeing those two numbers side-by-side, both cumulatively and for specific actions, I think would clarify a lot of the thinking that--and certainly we tend to talk past each other when we are only looking at one side of it in this Committee in the past---- Dr. Orme-Zavaleta. OK. Mr. Foster [continuing]. And that would allow you of course to look at the number of lives saved per dollar of cost, which is a very tough thing to talk about in politics, but really, you know, that's I think one of the lenses that we have to look at this through. And particularly in cases where the actions are delayed because of manpower limitations that might allow us to think about whether an investment here--to quantify whether an investment in increased manpower would save a, you know, roughly quantifiable number of human lives. So if you do get back with those. And if it turns out that you don't have those estimates, come up with a scope of a congressional request to get those numbers reported. I think it would clarify our thinking greatly. And thank you. I see my time is up, and I yield back. Chairwoman Sherrill. Well, thank you very much. Thank you to Dr. Orme-Zavaleta and Mr. Gomez for your testimony today. We'll now have a short break while we seat our next panel of witnesses. Thank you, everyone. [Recess.] Chairwoman Sherrill. Welcome back. At this time I would like to introduce our second panel of witnesses. Dr. Bernard D. Goldstein is a Professor Emeritus and Dean Emeritus at the University of Pittsburgh, Graduate School of Public Health; Dr. Ivan Rusyn, a Professor with the Department of Veterinary Integrative Biosciences at Texas A&M University, and the Chair for the Interdisciplinary Faculty of Toxicology. He also serves as the Director of the Texas A&M Superfund Research Center. Dr. Julie E. Goodman is a principal at Gradient, an environmental and risk sciences consulting firm with a focus on workplace and environmental chemicals. And our final witness, Ms. Wilma Subra. Ms. Subra is the Founder and President of Subra Company, Inc., an environmental consulting firm in New Iberia, Louisiana. She also serves as a Technical Advisor to the Louisiana Environmental Action Network. Dr. Goldstein, you are recognized for 5 minutes. TESTIMONY OF DR. BERNARD D. GOLDSTEIN, PROFESSOR EMERITUS AND DEAN EMERITUS, UNIVERSITY OF PITTSBURGH GRADUATE SCHOOL OF PUBLIC HEALTH Dr. Goldstein. Chairwoman Sherrill, Chairwoman Fletcher, and distinguished committee Members, I appreciate the opportunity to speak in front of this Committee again. To keep the time, I will focus on the core principles of why IRIS was developed and its relevance to today. It's not just my age that permits me to look back this far. I was Assistant Administrator for Research and Development appointed by President Reagan working under Administrators Ruckelshaus and Lee Thomas as IRIS was under development. My conclusion regrettably is that rather than streamlining, disemboweling is really what is happening here. We are destroying the current long-term scientific basis for how EPA functions. My background is detailed in my written testimony. I want to emphasize that through the years, I've worked closely with industry. In my current consultant work in toxic tort cases I have about equally an expert defending an industry as I am an expert for the plaintiff side suing the industry, and it depends upon the facts of the case. So why was IRIS developed? In 1983, soon after the NAS Red Book was released, I became EPA's Assistant Administrator for Research and Development. First, generally not known now, but EPA was already doing risk assessments. The problem was that the silo structure that characterized the EPA then and now made risk assessments a shambles. Now, this will occur again if assessments are removed from EPA's science offices to program offices. Different default assumptions were a key issue. Administrator Ruckelshaus recognized that for risk assessment to be useful, it needed to be sufficiently standardized and transparent so that, in his words, it would not be like beating a spy to get whatever answer you wanted. External transparent peer review is recognized as being crucial. And yet another reason for centralized ORD-led approaches, which I haven't heard discussed, is the obvious budgetary consequences because risk became--assumed a major role in assigning agency priorities. The program offices might want to increase the risk for air as opposed to water or water as opposed to air if, in fact, they are the ones allowed to have a say in what the basic approaches were. Subsequently, other important roles for IRIS have been recognized. The local purposes, which I'm glad to hear both Chairwomen describe--I recently had a paper--a document from the Allegheny County Health Department responding to a concern of local community, gentrifying community about some old industries there. It relied heavily on the IRIS process. It relied heavily on IRIS numbers, which were duplicated in this document. There's also a need to be responsive to national concerns that in a sense help us with world trade issues. We have something that's recognized worldwide in IRIS. If we politicize it, we will no longer be able to look back and expect other countries to use it because it'll be seen as a politicized effort rather than the science that it now is. And we need a centralized science--we need a centralized IRIS within ORD to decide whether and how to incorporate new science. And there is much new science related to hazard, related to dose response that has to be incorporated. It should be clear, Administrator Wheeler's decision to cut IRIS' budget, withhold its assessments from peer review, and move the formaldehyde issue is quite a contradiction of these founding principles. So let me conclude by saying that I have the deepest respect for Dr. Orme-Zavaleta--and I do call her Jennifer. I think she's doing really extremely well under the circumstances. But as the appointee of President Reagan confirmed by the U.S. Senate, I would have resigned had Administrator Ruckelshaus or Administrator Thomas tried to do the things that are happening now. I cannot recommend that the current AA of ORD resign; there is none, nor in the third year of this Administration even are rumors to whose name might be sent to the Senate. And it is unlikely that any reputable scientist would accept such a nomination. I would welcome answering questions about my overall written testimony, including transparency, about which I have previously testified in front of this Committee and about formaldehyde, which, as a hematologist and toxicologist, I've long been involved with. Thank you. [The prepared statement of Dr. Goldstein follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Chairwoman Sherrill. Thank you very much. Dr. Ivan Rusyn, you are now recognized for 5 minutes. TESTIMONY OF DR. IVAN RUSYN, PROFESSOR, DEPARTMENT OF VETERINARY INTEGRATIVE BIOSCIENCES; CHAIR, INTERDISCIPLINARY FACULTY OF TOXICOLOGY; AND DIRECTOR, SUPERFUND RESEARCH CENTER, TEXAS A&M UNIVERSITY Dr. Rusyn. Thank you. Chairwoman Sherrill, Chairwoman Fletcher, distinguished Members of the Subcommittees, I'm honored to appear before you today for this hearing. As a matter of disclosure pertaining to the topic of today's hearing, I'm currently chairing a workshop committee of the National Academies to support development of EPA's IRIS toxicological review. However, I appear before you today representing my own perspectives, not those of the Academies or the Texas A&M University. I would like to offer insights from my role as a researcher in the field of toxicology and a person with understanding of the process of developing human health assessment in general and those of the IRIS Program in particular. I have more than a decade of service as peer reviewer of various IRIS assessments, including 2011 Review of the EPA's Draft IRIS Assessment of Formaldehyde. I also served as a faculty fellow to the IRIS Program for 2 years where I interacted with IRIS staff in a variety of scientific methodological issues directly relevant to implementation of the advice from the National Academies. My laboratory is funded by the NIH (National Institutes of Health), the EPA, the National Academies, California EPA, and the European Petroleum Refineries Association. With respect to the Committee's interest in the role that IRIS plays in the field of chemical toxicity assessment, I note that it is difficult to overstate the importance of the IRIS Program to the protection of public health in the United States and abroad. Both the National Academies and the EPA themselves acknowledged the key role that IRIS-produced assessments play in many risk management decisions and superfund site cleanup. IRIS values are relevant for protecting the health and well-being of everyone, not only those who may be exposed in the workplace and not only by a narrow choice of the routes of exposure. As such, IRIS values are held to the highest standard in terms of the quality of their assessments, undergo exhaustive intra-government and external reviews, and the process generates very important and widely used toxicity values and classifications. With respect to the Committee's interest in the progress IRIS has made addressing recommendations from the National Academies, I note that a 2011 NRC (National Research Council) report: Review of the EPA's Draft IRIS Assessment of Formaldehyde offered a roadmap for the overall changes of the process, as well as some specific guidance. And the report did recognize that this process may take time and that EPA is fully capable of implementing suggested improvements, hence no delay in releasing other assessments was recommended. Two subsequent committees of the National Academies weighed in on the process and progress and have commended the IRIS Program for the work that they're doing. I fully agree with the conclusions of those reports. Overall, it is my opinion that substantial improvements in the IRIS process have been made in a relatively short period of time, and it is clear that the IRIS Program welcomed the advice it had been receiving from the National Academies and other stakeholders. The IRIS Program fully embraced the concept of systematic review. Systematic review is neither easy, nor it is straightforward, and the IRIS Program is to be commended for their leadership in this area. Also, a number of strategic decisions were made by IRIS to develop specific guidance documents and further standardize the process. A number of software solutions have been implemented, and investments in staff training and improvements to the interactions with outside stakeholders were made. It is disconcerting to me, however, that it appears that the IRIS Program lacks the support from the leadership of the EPA in terms of providing it with sufficient financial resources and adequate staffing. It has been stated in the 2019 GAO report discussed this morning that a number of recent events may have grave consequences to the ability of the IRIS Program to continue implementation of the advice from the National Academies to complete their draft assessments and to set further priorities commensurate with the needs of other offices at the EPA and of their other stakeholders. These developments are troubling, and I encourage the Subcommittees to look into the GAO report's facts and conclusions and to determine whether EPA may need to support and strengthen the IRIS Program, as suggested by the National Academies. In conclusion, it is my opinion that the IRIS Program has implemented the recommendations of the National Academies. The IRIS Program should be supported with adequate financial resources and staff. I also support strengthening the oversight by Congress of the implementation of the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Thank you for the opportunity to appear in this hearing, and I'd be happy to answer any questions the Members might have. [The prepared statement of Dr. Rusyn follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Chairwoman Sherrill. Thank you very much. Dr. Goodman, you're now recognized for 5 minutes. TESTIMONY OF DR. JULIE E. GOODMAN, PRINCIPAL, GRADIENT Dr. Goodman. Thank you very much for the opportunity to speak today. I am Dr. Julie Goodman, an epidemiologist and board-certified toxicologist at Gradient, an environmental sciences consulting firm. We assist public and private organizations in evaluating the risks of chemicals and other substances to human health and the environment. I have been developing and applying weight-of-evidence and systematic review methodology for over 10 years in a variety of settings, and I taught a graduate-level class on this topic at Harvard University. Much of my work has been published in the peer-reviewed literature. I'm presenting testimony today as an independent scientist. While my travel costs have been paid by my company, I'm here today on my own time and I am not being compensated for the time I spent preparing this testimony. As you heard earlier, in 2011, a National Academy of Sciences or NAS committee provided recommendations for the IRIS Program in the context of a review of formaldehyde. In response, EPA released a draft handbook for IRIS assessments in 2013, and then in 2014 and 2018, NAS reviewed and evaluated the IRIS assessment process more generally, including progress made since 2011. Both the 2011 and 2014 NAS reviews stated that the IRIS Program lacked a clear conceptual framework and clear and transparent methods. Further, NAS concluded that EPA did not fully assess the weight of evidence or justify the selection of studies for the derivation of toxicity values. The 2014 NAS review also specifically called for the finalization of the draft IRIS handbook. Since that time, EPA has made substantial improvements to the IRIS process, including the development and application of systematic review methods for evidence identification, evaluation, and integration, but not all of the identified issues have been resolved. To date, EPA has shown progress on a chemical-by-chemical basis using the IRIS Assessment Plans for uranium and ammonia and systematic review protocols for chloroform and chromium assessments as examples of its new portfolio approach. EPA announced it will move forward with a revised handbook, which will be put through peer review and public comment processes this year. This is undoubtedly needed and a critically important step forward, and EPA is to be commended for these actions. I note that while it is true that a one-size-fits-all protocol for all chemicals is not feasible, and details of the individual chemical assessments will vary based on the specific research questions identified and on the available data, all IRIS assessments will benefit from a clearly written framework that serves as a standard operating procedure, or SOP, for agency systematic reviews. The SOP can be expanded to include chemical-specific tailoring as needed to each phase of specific chemical reviews. An iterative approach can be used to incorporate new issues and knowledge into the SOP as it becomes available. To follow through on its intention to use systematic review and weight-of-evidence methodology for hazard identification, EPA needs to complete an individual assessment using the new process. My experience with developing these types of approaches has shown that it is important to apply a framework in a chemical-specific setting to determine where its strengths lie and where it falls short and should be revised. IRIS assessments both identify hazards associated with chemicals and characterize these hazards by generating toxicity values. With regard to the latter, EPA is always limited to studies with sufficient data for dose-response analysis, so the handbook should describe what will be done if these studies are not reflective of the science as a whole. In addition to studies that identify toxic effects, part of the hazard identification process is to consider studies that inform the mechanism of toxicity. EPA should indicate how it will consider this mechanistic evidence when deriving toxicity values. For example, if mechanistic studies clearly show a threshold effect, then it should be incorporated into the dose- response analysis, and linear low-dose extrapolations should not be applied. Now, there's no doubt that conducting systematic reviews takes more time and resources than nonsystematic reviews. However, a completed handbook that can and should be revised to reflect the best-available science will go a long way toward expediting assessments and increasing transparency and consistency across assessments. More importantly, with an established standard procedure in place, EPA staff will have better guidance to conduct IRIS assessments in a systematic and unbiased manner. This will allow stakeholders and members of the public to better understand the process and provide input and ultimately will increase their confidence in EPA's assessments. In conclusion, to address the NAS recommendations for the IRIS Program dating back to 2011, EPA needs to complete a general guidance framework for IRIS assessments and a revised handbook. EPA also needs to complete assessments that both apply this guidance and demonstrate that dose-response analyses and toxicity value derivations will be informed by the overall weight of evidence and biological mechanisms. Thank you very much. [The prepared statement of Dr. Goodman follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Chairwoman Sherrill. Thank you. Ms. Subra, I now recognize you for 5 minutes. TESTIMONY OF WILMA SUBRA, PRESIDENT, SUBRA COMPANY; AND TECHNICAL ADVISOR, LOUISIANA ENVIRONMENTAL ACTION NETWORK Ms. Subra. Thank you, Madams Chairwomen and distinguished Members of the Subcommittees for the opportunity to testify here today. I have provided technical assistance to community groups throughout the United States and in some foreign countries dealing with environmental and human health issues for more than 52 years. From the beginning of the publication available through IRIS assessment program, the information provided by IRIS has been extremely valuable in identifying health hazards of chemicals and evaluating exposure situations in the impacted communities. The toxicological information provides a complete evaluation of each chronic pathway of exposure and resulting risk. This information is critical in providing community members accurate and focused exposure and risk information per chemical. No matter what the situation, impacted community members are never exposed to just a single chemical. Focused on only one chemical or contaminant results in the underestimation of exposure, risk, and associated health. Community members' risk has to be included in all chemicals, all pathways of exposure, and all concentrations in all media in order to adequately identify the risk and develop pathways moving forward. When we look at the impacts of formaldehyde, formaldehyde is a precursor to many other chemical compounds produced by industrial facilities. In Louisiana, we have 31 major industrial facilities with more than 13 million pounds of formaldehyde being released into the environment each year. In Texas, we have 77 major industrial facilities releasing more than 819,000 pounds of formaldehyde into the environment each year. In the United States, we have 727 major industrial facilities releasing 19 million pounds into the environment. So an example of some of the communities that have been impacted by formaldehyde, the work I've done, in Natchitoches, Louisiana, there's a plywood mill. The citizens around the facility were very ill. We did air samples to determine that formaldehyde was the major toxic component. We went in and met with the company that was making the plywood and determined that they were using a formaldehyde-based glue or resin. Working with the community and the industry, they changed the kind of resin or glue that they were using, and therefore, the health impacts of the community were much improved. Then we have a Georgia-Pacific facility in Crossett, Arkansas. It has a pulp mill, it has a paper mill, and it has a chemical mill. The chemical mill actually makes the formaldehyde for use at all three facilities. The citizens complained of two things: Air emissions, odors of hydrogen sulfide, and formaldehyde. Hydrogen sulfide is the most disruptive to their health, but formaldehyde is the most toxic. Based on all the work with the citizens, we convinced EPA and they brought in the National Enforcement Investigation Center, which identified that the emissions of formaldehyde were being missed by the facility because they were using the wrong kind of detector to do their leak detection and repair. So, as a result of that, they issued them all sorts of violations and then in December of last year there came the penalty notice where they required them to pay $300,000 for each agency, that State agency and the Federal agency. They required them to do $1.2 million in restitution and $1 million over 3 years for supplemental environmental projects. These were all reduced emissions of the toxic chemicals, primarily formaldehyde. Then we have a self-help group that does housing for disadvantaged people. They were looking at changing to a contractor that build the houses and would put it on their lots. As it turned out, they were using a resin that had formaldehyde in it. We had conversations with them. They declined to change the kind of resin they were using. Therefore, the self-help group no longer even considered having those houses because they didn't want their environmental justice community members exposed. And then finally, we had the hurricanes of 2005, Katrina and Rita, a huge impact to Louisiana, Mississippi, Alabama, and Texas. And, as a result, we found out by doing sampling with Sierra Club that a large number of people were living in the FEMA (Federal Emergency Management Agency) trailers that were provided that had huge emissions of formaldehyde. We did 32 tests in one set. Thirty exceeded EPA's criteria for formaldehyde, 44 tests and 40 exceeded. As a result of that, 120,000 families were estimated as living in FEMA trailers with formaldehyde over the acceptable level. And in a FEMA trailer, it's an enclosed environment. Emissions into the air, everyone in the families are impacted. And so that was a situation where you did good for the community members but resulted in health impacts to those community members. And a large number of them were children and pregnant females. [The prepared statement of Ms. Subra follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Chairwoman Sherrill. Thank you. Thank you. Well, thank you to all of our witnesses. At this point we'll begin our first round of questions. The Chair recognizes herself for 5 minutes. So, Dr. Goldstein, in your testimony you spoke about the state of EPA chemical assessments prior to the establishment of IRIS. Can you please elaborate on the impetus to establish the IRIS Program and what needs it was filling that program offices were unable to address? Dr. Goldstein. Yes, the--IRIS to me was always a--sort of a smooth just continuation of the description of what I gave under Administrators Ruckelshaus and Thomas. How to name it was lots of debate. I remember one of the original ideas was the Coordinated Risk Assessment Program, but the acronym served to be of no value. The issue of how to move forward for EPA always came down to the natural tension between the program offices and a central administrative type of structure as the Office of Research and Development. And through the years that has just progressed. So it was just a building onto the issue of we need a centralized approach, the Administrator has to understand what the relative--what risk means to priorities and prioritize among the various problems that the Administrator was facing in responding to Congress. Congress needed to know which were the riskier problems that EPA was dealing with. And it should come from a central organizational structure with lots of external reviews. Chairwoman Sherrill. Thank you very much. And from our previous panel we learned that EPA's Office of Children Health Protection, or OCHP, believes formaldehyde is one of the top three or four IRIS priority chemicals for its office. That means formaldehyde is one of the major chemical dangers facing children today. Unfortunately, OCHP did not submit its priorities until it was too late in the process for them to be included. But, Dr. Rusyn, can you describe some of the documented health impacts of formaldehyde particularly for children and why our children are especially vulnerable to formaldehyde exposure? Dr. Rusyn. Thank you. I speak on my recollection from the information contained in the draft IRIS formaldehyde assessment that the committee that I served on reviewed in 2010 and 2011. I do not work on formaldehyde, so I'm not expert by any stretch of imagination. But the draft assessment included evaluation of the literature and derivation of toxicity values for inhalation exposure, which was of greatest concern. And the concerns that already were pointed out today especially from the particleboard in FEMA trailers and others, are something that is definitely bringing this type of a route of exposure to concern and especially because children are also exposed and are also considered a vulnerable population. This is something that the agency needed to account for in how they derived toxicity values from some of the studies in adults. So respiratory irritation and exacerbation of asthma and other types of respiratory illnesses were some of the health effects that were pointed out in the draft assessment. Chairwoman Sherrill. Thank you very much. And, Dr. Rusyn, since your participation in the 2011 National Academies' review of the draft formaldehyde assessment, what progress have you observed in IRIS' ability to implement the recommendations made and to increase its productivity and transparency? Dr. Rusyn. So, as I mentioned in my oral and written testimony, the process of IRIS evaluations is under a microscope and has been from all sides, from GAO, from Congress, from the National Academies, and from other stakeholders. The progress has been primarily focused on the process because the criticism that the 2011 report has provided was largely on the process and the transparency of the documents. So the systematic review process, the frequent releases of information that are now part of the IRIS Program's standard operating procedures increased transparency, increased the stakeholder engagement, and actually move the field forward. But it's important to note that risk assessment is not something that is stagnant. There's a lot of new data. There's a lot of methodological work, and I think IRIS is the leader in this pushing the methodology forward. Chairwoman Sherrill. And we have a few more seconds. How are they the leader would you say? Dr. Rusyn. The systematic review is something that is more established in the medical community where systematic reviews are undertaken to create centralized guidelines for certain conditions and for their treatments, so to standardize across different physicians and make sure that they're treating their patients based on best science. How to apply this process to environmental health was really unclear, so this is something that has only begun about 5 or 6 years. So IRIS Program has taken the leadership position in actually creating case studies and guidelines for this, so they're really pushing the field forward. Chairwoman Sherrill. Thank you. Thank you, everyone. And now the Chair will recognize Mr. Norman for 5 minutes. Mr. Norman. Thank you, Chairwoman Sherrill. Dr. Goodman, there's been a lot of talk about systematic review and higher standards to improve the IRIS Program. Can you explain the systematic review in layman's terms and describe why its implementation is critical to improving IRIS? Dr. Goodman. Yes, so the idea behind a systematic review is that there is a clearly formulated question and, based on that question, a protocol is developed for every aspect of the review, including the literature search strategy, what studies you're going to include and exclude, what information you're going to take from that--those studies, importantly, how you evaluate the quality of those studies, their strengths and limitations, and then how you integrate evidence from all these studies, especially when there's contradicting evidence, what you're going to do. And the reason why it's so critical is so that you truly get a sense of the whole state of the science. When a review is conducted that's not systematic, what ends up happening is critical information is ignored and then your conclusions aren't really based on a good solid scientific foundation. Mr. Norman. Thank you. And, again, Dr. Goodman, over the years, there's been a lot of uncertainty surrounding formaldehyde, specific criticisms of the IRIS Program's handling of the formaldehyde assessment. Last week, EPA announced that it will review formaldehyde in the TSCA program, which is an actual regulatory program that can set useful guidelines for the formaldehyde use. I think this is a tremendously positive step toward making meaningful determinations as to the risk associated with formaldehyde, and I applaud the Administration for taking this step. Can you--Dr. Goodman, again, can you please explain the potential downside of relying on an IRIS assessment of formaldehyde to dictate how we regulate that substance at the Federal level? Dr. Goodman. Well, I think, as it stands, the IRIS handbook hasn't been completed yet, so there's no standard operating procedure for conducting IRIS assessments. And so even though the assessments are moving in the direction of using systematic review, it hasn't--systematic review hasn't been fully implemented in any review to date, including what's been done on formaldehyde to date. So in that sense I think what's most important is that formaldehyde is reviewed in a systematic fashion. And I think the other aspect, as was talked about with the first panel, IRIS provides toxicity values and that--and these toxicity values take into account the hazard information, but they don't take the next step in saying what are uses, how are people using it, and what are the risks for those particular uses? And that is done under TSCA. Mr. Norman. OK. I'd like to thank each one of the witnesses for taking your time again. There's been a lot of controversy over IRIS, and we just want results. And thank you for taking the time. Chairwoman, I have no further questions. Chairwoman Sherrill. Thank you, Mr. Norman. I now recognize Ms. Bonamici for 5 minutes. Ms. Bonamici. Thank you so much to the Chairs and Ranking Members. Thank you to all of our witnesses for being here. I said during the first panel I've been on this Committee for more than 7 years, and I have sat through many hearings about IRIS and know that there--without question, there was a need to improve. But the direction that I'm seeing I do not consider improvement. Dr. Goldstein, in your testimony you discuss a development of the IRIS Program. I read your--back in the Ruckelshaus days and the importance of a centralized ORD-led approach to risk assessments and the value of independence of IRIS from other program offices. In a September 2017 letter, the EPA's Science Advisory Board reaffirmed that no other Federal entity performs IRIS functions and that IRIS helps ensure consistency in chemical assessment within the agency. I disagree with my colleagues who continue to call for the elimination of IRIS. And, Dr. Goldstein, based on your years of experience at the EPA, what are the consequences of diminishing the independence of IRIS? And how would consolidating the functions of IRIS into various program offices affect the quality of assessments? Dr. Goldstein. I think the quality of assessments would rapidly decline. It would be under the leadership of someone appointed as a political appointee to make sure that air is taken care of, water is taken care of, individual groups that have individual laws and they will respond by looking at ways that the risk be most supportive of what they think their policy approaches ought to be. We need an independent group that says what the science is and then everyone can use it but cannot play with it as much as would occur if you got rid of IRIS. Ms. Bonamici. Thank you. And, Dr. Goldstein, in your testimony you state that Administrator Wheeler's abrupt dismantling of extensive science-based independent review processes is unforgivable, and the current actions of EPA's leadership to be incredibly shortsighted at best. I'm very concerned about the lack of transparency, what appears to be a significant limitation on the number of chemicals that are being considered. I also appreciated the candid statement in your testimony that you would have resigned as Assistant Administrator of ORD if EPA leadership had tried to make the changes now being insisted on by Administrator Wheeler. I don't think we can brush this aside or ignore it. It's--I'm deeply concerned about the efforts to undermine scientific integrity and dismiss agency scientists and the EPA's work and the consequences that may endanger the EPA's ability to fulfill its mission. And we know that mission is protecting public health and the environment. What are the long-term consequences of the continued disrespect and dismissal of science at the EPA? Dr. Goldstein. Well, EPA will soon cease to function effectively. It will continue to have debate after debate after debate. The formaldehyde to me is a poster child of what happens when we let politics get in the way of making scientific--looking at the scientific basis for the decisionmaking. One can take the science and make a decision based upon what the laws are, what the policy issues are, but one should not discard the science and basically decide in advance I know what the science ought to be and then try to make policy on that. That policy will eventually fail. Ms. Bonamici. And thank you. And I have a question about the career staff. I know that there are still many career staff at the agency. How can we defend the work of the career staff when the EPA leadership is limiting the release of information to the public? What are your suggestions there? Dr. Goldstein. I think you've asked the most important question. My suggestion is as much oversight as you can give would be very, very welcome in this way. You know, hearings like this are just so important. And the career staff recognizes that. Ms. Bonamici. Thank you. And I want to reiterate what I mentioned in the hearing on the first panel that IRIS is an important program, yes. Based on the information we'd heard in the past and the recent GAO report, yes, there is room for improvement, and we can work together to bring about that improvement, but we absolutely must maintain the separation and respect the work of the career folks who are there trying to make sure that there is, science and transparency regarding IRIS and overall with the EPA. So thank you for your leadership, Chairwoman Fletcher and Chairwoman Sherrill and Ranking Members, and I yield back. Chairwoman Sherrill. Thank you very much. Now, the Chair recognizes Dr. Babin for 5 minutes. Mr. Babin. Thank you, Madam Chair. I appreciate it. And thank you, all you expert witnesses for being here as well. Dr. Goodman, do IRIS assessments integrate all lines of evidence, including potential adverse health effects to humans? Dr. Goodman. I think the goal of IRIS assessments is certainly to do that, and they do attempt to consider epidemiology, toxicology, mode of action, mechanistic evidence, but in practice sometimes relevant evidence is missed or in other times the evidence is all there but it's not evaluated in a systematic manner, meaning that, you know, not all studies are created equal. Some are more robust, they have more strengths. Others have more limitations. Just as an example, sometimes in epidemiology it's very difficult to estimate exposure, and some studies do a better job than others at coming up with good exposure measurements. So I think that can sometimes be an issue with IRIS assessments. Mr. Babin. OK. And then do IRIS assessments include any consideration of actual human exposures or make any determination of the actual human risk? Dr. Goodman. I believe that IRIS--the goal of the IRIS assessment is really to conduct a hazard assessment, and then once that assessment is done, it can then be used to evaluate risk---- Mr. Babin. Oh. Dr. Goodman [continuing]. Based on human uses of chemicals and exposures. Mr. Babin. OK. Does the TSCA program consider human exposure? Dr. Goodman. Yes, it does. Mr. Babin. OK. And also is it true that other chemical assessment agencies like the World Health Organization recognize a safe threshold for formaldehyde exposure when they establish values for long-term exposure to formaldehyde? Dr. Goodman. Yes, I believe the World Health Organization has acknowledged that the key mechanism for formaldehyde in causing cancer is through cytotoxicity and cell proliferation, and that specific mechanism has a threshold. And what that means is there's an exposure level below which the body can actually handle exposures to formaldehyde, and this won't happen. Mr. Babin. OK. Well, then would you elaborate on--just a little bit on the importance of setting these safe threshold values? Dr. Goodman. Well, I think the idea is--the goal of all of these programs is to determine what safe levels are or what levels below which we can be confident that there isn't an increased risk for adverse effects on human health. And so we need that based on the best available science, and if the science suggests that a mechanism of cancer or any other health effect has a threshold, has a level below which there is no increased risk, that needs to be incorporated in an assessment. Mr. Babin. I see. And, Ms. Subra, you had mentioned--are you from Louisiana by the way? Are you from Louisiana? Did I hear you say you had some studies in Natchitoches and---- Ms. Subra. Right. Mr. Babin [continuing]. Other areas? OK. Did you hear my last question? Would you like to elaborate on it as well? Ms. Subra. Could you repeat your question? Mr. Babin. Yes, OK. The importance of setting safe threshold values for anything---- Ms. Subra. Right. Mr. Babin [continuing]. But we're talking about formaldehyde here, if you would elaborate on that as well because I know that you've had a lot of experience with this. Ms. Subra. Right. So based on the citizens' complaints we did air sampling and found that formaldehyde was the chemical present in the largest quantity in the ambient air around the facility where these people live, and then being able to coordinate that back to the resins that were used by the facility, that was the source of those emissions. And then we worked with the facility to get those resins replaced, and as a result, the formaldehyde in the air was non-detect once they changed the resin they were using. So the health impacts to the community improved tremendously based on removing that source of pollution. Mr. Babin. OK. Thank you. And I yield back, Madam Chair. Thank you very much. Chairwoman Sherrill. Well, thank you. And now the Chair recognizes Chairwoman Fletcher for 5 minutes. Mrs. Fletcher. Thank you, Madam Chair. The EPA program--program and regional offices routinely utilize IRIS assessments to meet the agency's mission. Similarly, as I mentioned earlier, State regulatory agencies are also highly dependent on IRIS values. I have with me a letter from the Colorado Department of Public Health and Environment (CDPHE), and I would like to add it to the record. So I'll ask that the letter be added to the record. Chairwoman Sherrill. Without objection. Mrs. Fletcher. And this letter from the CDPHE unequivocally states that they utilize IRIS toxicity values daily to protect Coloradans' health. Additionally, nongovernmental stakeholders utilize IRIS assessments to better educate and protect impacted communities. Ms. Subra, and your testimony describe how you utilize IRIS assessments in your work. How regularly do you reference the IRIS assessment values? Yes. Ms. Subra. Depending on what facility and community I'm working with and what all the chemicals are that are being released by that facility, if there are some that I want additional information on, I'll quickly check the IRIS database and see if it's available. So it may be once a week, it may be once a month, it may be once every 2 months, depending on what new issues I'm working on. But on issues I'm working on a regular basis I check it to see if anything new has been added to that website to enable the citizens to better understand what's going on. Mrs. Fletcher. And what is it specifically about the IRIS assessments that makes them a valuable resource to you as compared to other toxicity values? Ms. Subra. So early in the--my career you'd have to have access to TOXNET and things like that, and only medical schools had access and they didn't share that access, whereas when you look at IRIS, they have all the literature available, and you can then, if you are interested in any particular one, get access to it. So it pulls together all of the available information and journal articles in one place. I don't have to go to three, four, five, or six places. And they've done the compiling for me so I can quickly have access to that, and it saves time as I'm trying to work and educate and empower the communities. Mrs. Fletcher. And on a related note in connection with your work, what impacts to your work do you anticipate if the IRIS Program is stifled in its ability to be able to produce timely and comprehensive assessments? Ms. Subra. So I only respond to communities that request assistance, and then I look to see what those chemicals are. One of the things we found is when IRIS does the assessment and does come out with it, then it takes a long time to get it implemented and get the results of their assessment to reduce the exposure going on in the communities by working with the industrial facilities that are sources of that emission. Mrs. Fletcher. And how will impacted communities be affected by a delayed IRIS process? Ms. Subra. They are affected because of primarily the air emissions. In a lot of other cases it's water, groundwater, and solid waste. But when they're affected by the air, then we need a handle to be able to say this is what's going on in the ambient air in the community around this facility or these facilities, and then, because of the IRIS information, then we can determine whether or not it's harmful to the community and what impacts it has on their health and then work with both the industry, the local, the State, and the national, environmental, and health agencies to get those emissions in the ambient air reduced and thus reduce their exposure. Mrs. Fletcher. Thank you. And I just have a limited amount of time left, so I'll put this question out to everyone on the panel, all the witnesses. Do you believe or why do you believe the value of IRIS assessments for external stakeholders has improved and increased over time? If anybody wants to take that question. Dr. Goldstein. Lots of hard work and lots of oversight and insistence that that information be available. Dr. Rusyn. And I think as well the level of scrutiny that this program has and the level of scrutiny that each draft assessment undergoes really provides the best available science for that particular protective value in the cancer hazard classification. Mrs. Fletcher. Thank you. And I see I've gone over my time, so, Chairwoman Sherrill, I will yield back. Chairwoman Sherrill. Thank you. The Chair now recognizes Ranking Member Marshall. Mr. Marshall. Thank you so much, Chairwoman. I'll start with Dr. Goodman. I'm trying to understand linear assessments. When, as a physician, we give a patient medicine, we start off with the lowest dose possible, and then usually you'll hit a certain dose to finally get the response you're wanting. And I never see a linear progression to the side effects. It looks like we just steadily go up and then suddenly, there's a number that causes side effects. And I would think, you know, trying to apply toxicology might be the same in reverse. So do you typically use some type of linear analysis or is there typically drop-off points? Dr. Goodman. So right now, cancer is evaluated differently than noncancer effects, so for noncancer health effects, it's exactly as you say. When assessments are done, it's assumed that a minimum exposure is necessary to see any type of toxic effects, and below that exposure, those effects won't occur. Now, it's actually--it's based on a regulatory context, not based on biology, this idea that if there's something that can cause cancer, one molecule of that something can cause cancer. And so they do this process called linear low-dose extrapolation meaning obviously you can't do a scientific study of one molecule, so you take the higher doses and basically plot out on a curve what the association is between the dose of the chemical or exposure of the chemical and cancer risk, and then you extrapolate from that lowest dose down to zero, essentially assuming that there's risk down to zero. But if-- biologically that's not necessarily the case, particularly for certain carcinogens that have certain mechanisms. And in that case you should do exactly as you said. You should find the exposure level--the minimum exposure level where you can increase cancer risks, and then below that there's no evidence for an increased cancer risk. Mr. Marshall. How do you take the IRIS assessment cancer classifications and then apply them to actual human health risk? How do companies do that? The IRIS assessment cancer classifications and then I'm trying to relate that from taking that data to human risk. Dr. Goodman. Well, I think the idea--I mean, if you're talking about cancer, so a cancer slope factor, a number is calculated, that's an estimate of what--you know, what cancer risk is associated with specific exposures. But, as I said, there's this extrapolation down to low exposure levels because that can't be studied and so, by design, it is overestimating cancer risk. Mr. Marshall. Do private companies feel like IRIS has been transparent? Dr. Goodman. I don't know that I can speak for private companies, so I don't know that I should answer that. I think in some cases I would say I've heard---- Mr. Marshall. Does industry feel like IRIS has been transparent? Dr. Goodman. Again, I don't know that I should speak for the industry, but I think there are some cases where the scientific judgments have not been clear in IRIS assessments. Mr. Marshall. OK. If you were in charge of IRIS, what solutions would make it better? What are your thoughts to improve IRIS? Dr. Goodman. First priority is complete that handbook because then we have a standard operating procedure so that all assessments are done in the same manner. Also make sure that all protocols and then actually the executed assessments are completely transparent so it's absolutely clear when decisions were made and the basis for those decisions. Mr. Marshall. Why has it taken so long to do it? Any idea? I'm kind of new to the game here. What have they told you why they haven't gotten it done before? Dr. Goodman. I don't think I'm the right person to answer that. Mr. Marshall. OK. All right. Think here for a second. Mr. Goldstein, what do you think--I mean, certainly, there's been a handbook that they'd used for decades I would assume. They have to have one. You could not supervise a lab without a handbook. What's taken so long to get this to Congress and to all of us? Dr. Goldstein. Sir, may I first answer the question you asked before? I'm a physician, and you used the issue of toxicity. Mr. Marshall. I guess I'd really--I got 38 seconds left, so I'd rather you answer this question. Dr. Goldstein. OK. I'll be--may I send that to you? Mr. Marshall. Sure. Dr. Goldstein. The answer to this question is simple, I just don't know. I'm not active at EPA right now. I do know that doing something like a handbook, unless Congress requires me to do it, in which case it becomes highest priority, is really not that easy on a moving subject like this. And as new science is brought in, as you heard about systems approaches, boy, by the time you get this finished---- Mr. Marshall. I would say the first 20 steps are the same, though. The first 20 steps should be the same no matter which substance we're looking at, and I just can't believe it's been 8 or 10 years. Thank you, and I yield back. Chairwoman Sherrill. Thank you. The Chair now recognizes Mr. Tonko for 5 minutes. Mr. Tonko. Thank you, Chairwoman Sherrill. And welcome to the panel. I firmly believe that we must ensure that inappropriate political interference in the scientific process does not get in the way of protecting our national security and public health. And, Dr. Goldstein, I know that you had an earlier exchange with my colleague, Representative Bonamici, and I wanted to delve a little further. But before I do that, why don't you express what you wanted to express if you could do that in a matter of seconds. Dr. Goldstein. OK. It's a very good question asked by Dr. Marshall. It had to do with toxicity. You see the toxicity very quickly, though, so if you're going to change the dose of a drug and see toxicity, that's an immediate response. Cancer is 20, 30 years later. You won't see it as a physician. So it's not really pertinent to the way they do risk assessment, although it's a very good question. Mr. Tonko. OK. Thank you. And now back to political influence. In your testimony you touch upon how the current political manipulations in the IRIS Program reflect the general dysfunction at the EPA over the past 2 years, particularly with the CASAC (Clean Air Scientific Advisory Committee) particulate matter review. You go so far as to state that, and I quote, ``There is no question that today we are at the lowest point ever since the formation of the EPA,'' close quote. This is alarming to hear from someone who has been a close observer of the agency for decades, particularly since you came to work at the EPA following the infamously dysfunctional and frequently hostile tenure of former Administrator Anne Gorsuch. How does this Administration follow the pattern of behavior exhibited by that Gorsuch EPA, and what makes this the lowest point in the agency's history? Dr. Goldstein. That's an easy question to answer. You mentioned the Clean Air Scientific Advisory Committee. Before becoming Assistant Administrator, I chaired that under Anne Gorsuch. Anne Gorsuch did not interfere with the actions of the Clean Air Scientific Advisory Committee. Administrator Wheeler is. Mr. Tonko. Well, what do you believe is the goal of these attempts to undermine science at the EPA wherever possible? Dr. Goldstein. Policymakers like to get the science they want rather than the science that exists. I mean, it's built into the tension of how we develop our regulations and how we protect the public. Mr. Tonko. So sheer manipulation. Dr. Goldstein, in your testimony you mentioned that when you found evidence that benzene is leukemogenic using funding from the American Petroleum Institute, your funding was cutoff. While you say you maintain respect for the scientific aptitude of industry, I must say this is troubling to hear. When you were working for industry, was there an understanding that your funding was dependent upon a particular outcome? Dr. Goldstein. They never said that they cut it off because of the outcome. They were short of money that year was the reason they gave. I think we all understood what the answer really was. But, no, the issue of working with industry I think it's really important. I think good scientists in academia should work with industry, but it must be done in a way that's very careful and must be understood exactly what industry wants. On the formaldehyde issue, I was asked to consult with industry right after the IARC (International Agency for Research on Cancer) meeting in 2010 said that it was a known leukemogen, and I told them they had to repeat the key study. They have yet to repeat it. Instead, they fund consultants to nitpick the study. Mr. Tonko. OK. Thank you. And given your experience, what is your impression of the insistence by the American Chemistry Council that the studies it funds exonerating formaldehyde are sufficient to upend or at least call into serious question the current weight of evidence regarding formaldehyde carcinogenicity--whatever--carcinogens---- Dr. Goldstein. Cancer causation, sir. Mr. Tonko. Yes. Dr. Goldstein. These studies just indicate why this transparency idea is simply a ruse to be able to get raw data, not to be able to repeat the study but to be able to nitpick the study. Consultants get paid for nitpicking studies, changing blemishes into scars so that we will think there's a real problem. One of the studies is one that I responded to in print showing that their own data if anything proved the-- proved is too strong, but certainly strengthened the initial study, not discredited it. Mr. Tonko. Thank you very much. I just want to make a statement that scientific integrity is about, in my opinion, ensuring a process and atmosphere in which the science leads us to the results. Public science informs national policy on everything from pesticides to power grids. Our Nation's cities and States need credible information to prepare for climate change, and our families deserve to know if unsafe chemicals are being sprayed on their food, dumped into their water supplies, or added into the products they buy. The efforts to silence science, distort, and bury or delay the release of valuable science at EPA--and they serve as a reminder of the urgency of passing the Scientific Integrity Act, which I've introduced, to codify the requirement that all agencies have strong scientific integrity policies that ensure that science leads the way no matter the Administration. Anything short of that is simply unacceptable. And with that, Madam Chair, I will yield back. Chairwoman Sherrill. Thank you so much. I'd now like to recognize Mr. Cohen for 5 minutes. Mr. Cohen. Thank you, Madam Chair, and Merritt's mother. Dr. Goldstein, I am obviously not a toxicologist, not obviously but I'm not. But Mr. Marshall asked some questions earlier about ethylene oxide. He expressed concern that IRIS risk values for inhalation of ethylene oxide are 19,000 times lower than what the human body naturally produces. Do I have to go further? I see your kind of--you're ready to respond. Isn't it true that the human body produces and expels a lot of substances that it would be dangerous to consume or inhale? And is the presence of a chemical in some concentration--in the digestive system, for example--going to mean the same level of risk as if that chemical is found in your lungs? So can you tell us about comparing these different levels and various-- also the chemicals if they're in the soil versus the air versus the water we drink, et cetera, et cetera? Dr. Goldstein. Thank you for the question. The--what's fascinating to me is that industry has welcomed some recent research, which I think is pretty good research, that shows that about one-third of the--in my estimation, about one-third of all cancer is due to bad luck. Well, what--yes, I mean, it's going to happen whether we were exposed to anything or changed our environment. That's not true for all cancers, certainly lung cancer, others. But if you start with that as something that industry believes, well, that means it's something internal to our body. Well, if our body makes formaldehyde and ethylene oxide, those are likely causes of this if you live long enough you're going to get mutations to yourself that will cause cancer, which is what bad luck really is about. If you believe that, then clearly ethylene oxide can cause cancer and basically would be responsible for some bad luck. And if you think of it from the point of view of numbers, about 25 percent of us will get cancer. If one-third is due to bad luck, that's about 8 percent of us. If we're talking about Congress telling us we have to regulate it, say, 1 in 100,000 risk, well, 1 in 100,000, 8 percent of that is, what, 8,000 in 100,000 is due to this bad luck. If you're telling us to regulate 1 in 1,000, a little bit more of ethylene oxide from the outside, a little bit more formaldehyde from the outside could easily produce that 1 in 8,000 that I just talked about, and that's the level that IRIS is supposed to be informing people about. So it--to me it doesn't--I just don't understand why ethylene oxide being an internal causation should make any difference to the IRIS approach. Mr. Cohen. Now you've got me totally confused. Dr. Goldstein. Sorry. Mr. Cohen. I took an aspirin religiously, taking it from right to left of course, for years, and then I read recently that for people that are--have the ability to remember Bill Mazeroski that this was a bad thing to do, that it was going to be hazardous to my health. Now you're telling me that cancer is caused by water. So is it--what---- Dr. Goldstein. I didn't say that. Mr. Cohen. Well, I'm just thinking, is it kidney stones or is it cancer? Do I have to make a choice? Dr. Goldstein. No, please don't make that choice. But there is--I mean, none of us lives forever, and, as I said, there is reasonably good evidence that mutations occur spontaneously in the body for causes we don't understand but could well be ethylene oxide or formaldehyde or other carcinogens we make within our body, and that these represent--as I say, it's only one-third of cancer, so two-thirds are out there ready to be prevented. But if it's one-third, that's still, in relationship to the 1 in 100,000 risk, which isn't IRIS' choice. That's, if you will, your choice. That's the level of protection that the country wants. It's a very big number. Mr. Cohen. Let me ask you this. You worked at the EPA when President Reagan was in office, is that correct? Dr. Goldstein. Correct. Mr. Cohen. And Reagan was kind of known as a conservative and a guy that was pro-business. How would you compare Ruckelshaus and other EPA Administrators to Scott Pruitt? Dr. Goldstein. There's no comparison. I mean, it's--you're talking about a completely different approach. The respect for getting the science right from Bill Ruckelshaus, Lee Thomas, the two Administrators I worked under, was very strong. And, as I say, Anne Gorsuch did not interfere with the Clean Air Scientific Advisory Committee. I chaired it. Mr. Cohen. And then the Reagan Administration didn't try to interfere with EPA from giving information to the public to protect them as this Administration is? Dr. Goldstein. That's not--that wasn't my level of approach, so I can't really comment on that, but I do--on the other things, I certainly do feel there's a difference. Mr. Cohen. Thank you. And I yield back. Chairwoman Sherrill. Thank you very much. I now yield 5 minutes to Ms. Wexton. Ms. Wexton. Thank you, Madam Chair, and thank you to the witnesses for coming to testify before us this morning. Dr. Goodman, what kinds of organizations fund Gradient's research? Is it nonprofit organizations, trade organizations, corporations? What kind of groups fund your research? Dr. Goodman. We--it really runs the gamut from private to public and government and nonprofit and for-profit and trade groups. Ms. Wexton. OK. And some of the groups that you've done work for include the National Marine Manufacturers Association? Do remember doing some work for them? Dr. Goodman. I believe so, yes. Ms. Wexton. The Styrene Information and Resource Center? Dr. Goodman. Yes. Ms. Wexton. The Formaldehyde Council? Dr. Goodman. It--I don't remember, but it's possible. Ms. Wexton. OK. BPA Global Group? Dr. Goodman. Yes. Ms. Wexton. The American Petroleum Institute? Dr. Goodman. Yes. Ms. Wexton. ExxonMobil? Dr. Goodman. Yes. Ms. Wexton. The American Chemistry Council? Dr. Goodman. Yes. Ms. Wexton. OK. So are you--have you heard of this--the analysis by the Center for Public Integrity of 149 Gradient- produced scientific articles and letters that found that 98 percent of the time the research that was conducted by scientists at your company concludes that the chemical in question is harmless at levels to which people are typically exposed? Are you aware of that study? Dr. Goodman. I'm familiar with that article. I haven't looked at that statistic in a while, but if I remember correctly, it was quite misleading, and I'm happy to go back and look at it and provide you with something more---- Ms. Wexton. So you don't agree that it was 98 percent? Dr. Goodman. No, I do not. Ms. Wexton. OK. So can you then give me an example of a time during your research at Gradient that you came to conclude that the exposure for--the exposure threshold for a particular chemical should actually be lower than an existing standard would suggest? Dr. Goodman. I don't know--I can't think of--not everything I do has to do with standards and whether the standard should be lower or higher, but I'm certainly--you know, the first thing that comes to mind was when I was doing an evaluation of a chemical in a toy and basically coming to the conclusion that there was a possible toxic effect for children playing with the toy, so that's just the one off the top of my head. Ms. Wexton. So was that a specific level that you came to conclude was--should be lower than what it was at the time? Dr. Goodman. Well, basically that the chemical shouldn't be in the toy at all because there was a not at risk. Ms. Wexton. OK. And in your research at Gradient, can you give me an example of a time that you came to a conclusion that a chemical you were hired to study is carcinogenic at typical exposure levels? Dr. Goodman. Again, I don't know--I--the types of things we do range from hazard assessment to risk assessment, so it's not always about, you know, common uses and what people are typically exposed to, but I'm actually--you know, this isn't cancer, but I--I'm thinking now I actually have in the published literature and actually some of this work was funded by the American Petroleum Institute, as you mentioned, and some by actually the Texas Commission on Environmental Quality, which is a government agency, where we looked at air pollutants and risks of asthma and some other respiratory effects, and we did find that there was an increased risk for certain effects. So--and again, I'm happy to give you a list of that if you---- Ms. Wexton. And was that research that you specifically participated in at Gradient or just peer-reviewed articles and scholarly journals that you have read? Dr. Goodman. It was research we--I'm not exactly sure what the question is. It was some--we've done some original research where we actually look at air pollution data and health outcomes, and then we done systematic reviews like we're talking about here today where we looked at all the published studies and said what it came to together. And all of that work has been published in the peer-reviewed literature. Ms. Wexton. And have you ever worked on a study for Gradient where the client proposed their own conclusion, that is, what they were hoping that the data would show? Dr. Goodman. I--not that I can think of, but in the end, it doesn't matter. I mean, that's--we get hired to do independent scientific analyses and conduct them with rigor and transparency and adhere to the highest scientific principles. Ms. Wexton. And, Dr. Goldstein, in your testimony you indicated that you have some extensive knowledge or experience working with industry. And based on your knowledge of industry- supported science, how frequently are results found that contradict the business interests of the company or trade group that's funding the research? Chairwoman Sherrill. And if you could answer quickly. The gentlewoman's time---- Dr. Goldstein. I will say not that unusually internally. I mean, that's the role of internal scientists and industry is to keep them out of trouble by having them not do the wrong thing, so that's not uncommon. How much gets public is---- Ms. Wexton. Is another story, right. Thank you very much. I yield back. Chairwoman Sherrill. Thank you. And now, I believe the Ranking Member, Mr. Norman, has a question he would like to add, so I yield 1 minute to him. Mr. Norman. Thank you, Chairwoman Sherrill. Just to kind of follow up with this conversation we've been having, I mean, Dr. Goodman, you're independent, and I think Dr. Goldstein was mentioning as independent contractors if you will you may cherry-pick different things to have a desired outcome. Of all the companies you've had, have you had anybody put pressure on you to come up with an outcome that may or may not be what they wanted? Dr. Goodman. The answer to that is no. Again, I get hired to do independent analyses. But I think this whole idea of systematic review and transparency, that's kind of the whole point. That is the work I do. I use a protocol, we do it systematically, and everything is transparent, so the idea is anyone can see the methods we use, the judgments that were made. Mr. Norman. And I'm in the private arena, and we hire a lot of consultants. For liability reasons alone, it would not make sense for us to put any pressure on any business. We want to be protected--as I think Dr. Goldstein mentioned, we want to be protected, and the easiest way to have--invite a lawsuit is to try to have a desired outcome, which is not the end result. The media portrays that, but it's--in real life, in the real world that's not how it works. Thank you so much. I yield back. Chairwoman Sherrill. Thank you to the Ranking Member. Before we bring this hearing to a close, I want to thank our witnesses for testifying before the Committee today. The record will remain open for 2 weeks for additional statements from the Members and for any additional questions the Committee may ask of the witnesses. The witnesses are excused, and the hearing is now adjourned. Thank you. [Whereupon, at 12:55 p.m., the Subcommittees were adjourned.] Appendix I ---------- [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Appendix II ---------- Additional Material for the Record [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] [all]