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Evaluating the science and process behind chemical risk assessment

Regulatory reform, specifically with regard to chemical risk assessment, took center stage this week.

On Monday, ACC President Cal Dooley addressed members of the Toxicology Forum at their 37th Annual Summer Meeting in Aspen, CO. Protecting public health and safety is the top priority of government and industry, and Dooley outlined how sound chemical risk assessments and effective chemical regulation based on today’s scientific knowledge are a crucial part of continuing to fulfill that goal.

Risk assessment was again the subject during Dooley’s testimony Thursday before the U.S. House Subcommittee on Investigations and Oversight (of the Committee on Science, Space, and Technology). He was invited to present ACC’s case for overhauling EPA’s Integrated Risk Information System, or IRIS.

As Dooley mentioned in his testimony, IRIS is one of the most important programs EPA uses to assess the safety of chemicals. But it has been met with substantial criticism over the years for failing to meet high standards of scientific inquiry, transparency and quality.

ACC believes it is time to fix the IRIS program to protect health, safety and the environment while preserving the ability of American industry to innovate, compete and create jobs.

Below, I’ve included a copy of Dooley’s keynote speech before the Toxicology Forum. As always, we welcome your input on this or any other policy matter.

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It’s a pleasure to be speaking to the Toxicology Forum’s annual meeting.

I’m not a toxicologist or scientist by training. I did serve in the House of Representatives for seven terms. As many of you may suspect, there seems to be an unspoken prerequisite that to serve in Congress you must know little to nothing about science. But a lack of experience or expertise never stopped a current (or former, in my case) member of Congress from opining on scientific matters.

As a member of Congress you also get used to speaking to groups of people who know infinitely more about any particular subject than you do, which is certainly the case today.

But even though I’m not a toxicologist, I have come to deeply appreciate the work that you all do, and its relevance to what I do. As President of the American Chemistry Council, I am an advocate for America’s chemical manufacturers. It’s my job to fight for processes, policies and regulations that are clear and effective so the mutual goals of protecting health and the environment and preserving the chemical industry’s ability to innovate, compete and create jobs can be achieved in a way that will support our country’s overall well-being. The advanced scientific understanding and methods that those of you in this room develop and perfect, as well as the highest standards of scientific integrity that you strive for, are essential to achieving both goals.

The value of rigorous, transparent chemical assessments that fully leverage your work should be a shared interest among industry, activists, government and even everyday consumers. What you do (or what I do) may seem far-removed from the proverbial “average Joe” but actually it’s not – it’s “Joe” who depends on countless goods that rely on chemical ingredients to make his life healthier, safer, more productive and more sustainable. The ability of our industry to make those ingredients; of manufacturers to use them; of retailers to sell them; and of consumers to buy them with confidence must be built upon a solid scientific foundation.

Shortly after taking office, President Obama gave our industry and many others hope that his administration shared this view by saying that science and the scientific process would guide policy decisions of his Administration.

Those are strong words, and ones that we welcomed. Unfortunately, since the President spoke these words to the National Academy of Sciences (NAS) in the spring of 2009, our optimism and confidence in the Administration’s consistent commitment to scientific integrity in the regulatory process has eroded.

This is in large part due to troubling inconsistencies, inefficiencies and lack of transparency in the federal system for assessing the safety of chemicals. Today’s risk assessments rely on outdated practices and assumptions rather than proven data and current understanding of how chemicals interact with our bodies and our environment.

Perhaps the best example can be found in EPA’s Integrated Risk Information System, or IRIS. IRIS is one of the most important programs EPA uses to assess the safety of chemicals, and it serves as a leading source of health risk information for other federal, state, and international regulatory bodies. But over the years the program has been criticized for failing to consistently meet high standards of scientific inquiry, transparency and quality.

Three specific examples come to mind.

First is the IRIS program’s assessment of dioxin in the mid nineteen-eighties, which remains a point of contention today. The IRIS review was submitted to EPA’s own Science Advisory Board (SAB) in 1995 and to the National Academy of Sciences in 2003. Both criticized the conclusions of the dioxin assessment and recommended improvements to the IRIS program. The report and subsequent actions of EPA in response have been re-reviewed by the SAB and NAS in the years since.

Despite continuing critiques, sixteen years later, these recommendations have gone largely unaddressed. Specifically, the Science Advisory Board clearly stated that a linear model was not scientifically supportable for dioxin and instead EPA should use a threshold model of extrapolating risks to humans. Despite this direction, the IRIS office continues to steadfastly default to a linear model, even when the data indicates that the threshold model is more relevant.

Second is the case of hexavalent chromium (Cr6). In 2009, industry undertook a multi-million dollar mode-of-action research program to develop new data that EPA could use to assess the risk that Cr6 poses from low-level, environmentally-relevant exposure through drinking water. The research was directly responsive to the data needs of the EPA, and EPA staff was consulted during the process of developing the research plan.

Despite the pending research, due later this year, the agency significantly accelerated its timetable for the hexavalent chromium IRIS assessment. EPA published the draft in late 2010. An independent peer review group expressed significant concerns about the scientific quality of the draft assessment, siting knowledge gaps, including those that could be filled by the industry research. EPA has not taken steps to incorporate the comments of the peer review panel and still intends to finalize the IRIS assessment by the end of September, about the same time that the new research should be completed. This will result in a risk assessment that will be out-dated and inaccurate as soon as it is released.

Third, and perhaps the most illustrative, is the recent case of formaldehyde. Formaldehyde has been the subject of scientific study for years. Numerous organizations including the World Health Organization have concluded that a large body of evidence shows that the levels of formaldehyde most people encounter do not cause adverse health effects. EPA completed an IRIS review of formaldehyde in 2010, asserting that a link exists between exposure to formaldehyde and certain types of leukemia. EPA’s conclusions quickly came under scrutiny. To provide clarity, the National Academy of Sciences was asked to convene an expert panel to review the findings.

NAS issued its report earlier this spring, and in it they questioned the evidence EPA used to support its conclusion. NAS found that EPA’s assessment “was not prepared in a logically consistent pattern,” and “conclusions appear to be based on a subjective view of the overall data and the absence of a causal framework for these cancers is particularly problematic given the inconsistencies in the epidemiologic data, the weak animal data and the lack of mechanistic data.”

In its report, NAS also offered a scathing critique of the IRIS program in general. NAS included an entire chapter devoted to the improvements needed by EPA to address the IRIS program’s long-standing weaknesses.

Having confidence in the scientific foundation of hazard evaluations and risk assessments of chemicals is fundamental to EPA’s mission to protect public health and the environment. The IRIS program of today fails to support that mission.

The program’s assessments have not evolved with scientific understanding. They still rely on assumptions developed in the 1970s. And while NAS served as the honest broker after EPA’s review of formaldehyde came under attack, typical reviews of EPA’s IRIS reports lack the kind of rigor and consistent independent peer review that is charactaristic of scientific research programs.

There are no clear criteria for selecting chemicals that should undergo IRIS review. A recent news story stated that Rebecca Clark, acting head of the National Center for Environmental Assessment, said EPA has selected 12 high priority chemicals for IRIS assessments based on nominations from the regions and program offices. While this may reflect concerns, perceptions, or even bias, it is not reflective of a sound scientific process for identifying high priority risks.

These shortcomings in the IRIS process make IRIS assessments vulnerable to charges of inaccuracies and influence.

ACC has called for EPA to immediately require NAS review of all IRIS assessments and that EPA report back to NAS about how it will accommodate suggestions. In addition, ACC is leading the charge to pursue fundamental changes to IRIS that will reflect the NAS’ recommendations from the formaldehyde report.

Congress, too, has taken note of the deficiencies of the IRIS program. Later this week the House Committee on Science, Space, and Technology will be holding a hearing on the subject at which I will be testifying and outlining our position. Our proposals are consistent with the NAS recommendations included in the formaldehyde report. Specifically we are calling for IRIS to adopt a consistent, systematic weight of evidence framework that incorporates transparent and rigorous data evaluation methods; 21st century knowledge of toxicological modes-of-action and proven approaches for evaluating cause, effect, and uncertainty; and an enhanced public comment and scientific peer review processes.

In many ways, the erosion of the IRIS program, rather than its evolution with modern understanding and technology, is a shame. Those of you in this room as well as your colleagues in academia, research institutions and industry have invested your professional lives to improve our understanding of how chemicals act at the molecular, cellular and organism level. You are the source of the best available science that should form the foundation for objective and accurate assessments of chemicals. But as it exists today, IRIS does not reflect those achievements. Therefore, your work is not being effectively and fully utilized in government assessments and subsequent potential regulatory decisions.

As I said at the outset, IRIS reflects systemic problems with the Administration’s approach to chemical risk assessment and chemical regulation generally. We believe a discussion is warranted about whether a hazard-based approach to chemical assessments is appropriate in this day and age; that the bureaucratic process should be streamlined and better coordinated; and that greater consideration should be given to the economic consequences of a classification as it relates to the actual risk to individuals that are exposed to a particular chemical.

Recent developments related to formaldehyde also illustrate these systemic problems.

Just weeks after NAS concluded that EPA’s IRIS program had failed to scientifically justify its conclusion that formaldehyde causes certain types of leukemia, the National Toxicology Program (NTP) came to the exact opposite conclusion in its 12th Report on Carcinogens, known as the 12th ROC. The explanation? The ROC evaluates only hazard and is not meant to take other factors into account.

In a time when scientists like you can detect the most miniscule traces of chemical substances in the body – down to the parts-per-trillion – is an assessment based on hazard alone even useful anymore? I would argue no. What does the fact that a part-per-trillion is present in the body even mean? That information alone is not meaningful. To be useful, assessments must take modern understanding of exposure, mode-of-action and risk into account.

Because the NTP relies primarily on hazard, the 12th RoC produced a determination about formaldehyde that is of little to no practical use to the vast majority of the American public, because they are generally exposed to very low levels of formaldehyde during the course of their lives. But the information and summary fact sheets provided by NTP along with the report do not adequately provide that context.

The simple designation “known human carcinogen,” and the subsequent media coverage has created significant potential for public confusion, alarm, litigation and economic harm all without adequate scientific basis. The irrelevance of the listing was essentially acknowledged by the report’s own authors as they attempted to put its conclusions in context, after the fact. John Butcher, the associate director of the NTP, even said that he’s not worried about his own exposures. “I probably won’t be making many changes.”

In addition to EPA’s IRIS program and the NTP’s RoC, the Agency for Toxic Substances Disease Registry (ATSDR) also manages a separate toxicological profiles program. IRIS, NTP and the ATSDR programs are all housed within different federal departments or agencies, employing different methods for assessing chemical risk. This overlapping and duplicative system often produces conflicting conclusions and guidance. Therefore it is no wonder that the public, as well as private enterprise, remain confused and distrustful of the chemical regulatory system overall and its efficacy.

To provide lawmakers, industry, activists and the public with greater confidence, we must implement reforms not only to the IRIS program, but to government risk assessment processes as a whole, and to our overall chemicals management system. Credible, accurate, modern science must serve as the foundation of these reforms and for every element of the regulatory process.

We must enact a more rational approach by putting an end to the proliferation of conflicting chemical risk assessment programs. There must be a quarterback to ensure that assessments apply a sound scientific approach. To that end, ACC has proposed that the Office of Management and Budget (OMB) take a greater role in reviewing both the processes of various agencies that evaluate chemicals, the current value of these programs and when necessary, the assessments themselves. Only such a review by OMB can guarantee that the letter and the spirit of President Obama’s 2009 memorandum are consistently followed.

And we must modernize the overall chemical regulatory system in this country, of which risk assessment is just one part. As you may know, ACC supports reform of the Toxic Substances Control Act (TSCA), but we believe that the same characteristics that are essential to IRIS reform must be applied to TSCA. The regulatory system must be based on transparency, modern scientific understanding and a sophisticated, efficient approach to regulation that is based on the combined concepts of hazard, exposure and risk.

This is one the primary reasons we have been unable to support legislation introduced by Senator Frank Lautenberg. The safety standard prescribed in his bills is simply unworkable because it applies a hazard-based approach that requires “reasonable certainty that no harm will result from aggregate exposure.” It does not factor in how a chemical is used, how and at what levels humans may be exposed to the chemical; and what risks exist at various levels of exposure – all critical pieces of information for an informed regulatory process and decision.

We also believe that Senator Lautenburg’s bill would stifle innovation, weaken protections for confidential business information and create an unreasonable cost burden for new chemicals.

And the legislation lacks a well-defined and practical prioritization system. Without a transparent and rational prioritization scheme, endless time, energy and resources could be spent gathering information and analyzing data on thousands of chemicals, rather than focusing safety determinations for the highest priority chemicals.

Protecting public health and safety must be the top priority of government and industry, as I’m sure it is the top priority of those of you here today. Sound chemical risk assessments and effective chemical regulation based on today’s scientific knowledge are a crucial part of meeting that goal. While there is significant work to be done to improve both, ACC has put forward concrete, feasible changes that could be initiated today.

Ensuring that the work you have done, and will continue to do is incorporated into the way we approach chemical safety and regulation, is a critical part of the solution. We welcome the input from experts like those of you here today, and would encourage you to make your voices heard. You, better than anyone, can speak to the importance and complexity of these issues.

Thanks very much for giving me the opportunity to speak. With that, I’d be happy to take your questions. I would note that Rick Becker, ACC’s senior toxicologist, is here today as well, and I will be looking to him to help answer your more technical questions.



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