EPA method will curtail science used in chemical evaluations

EPA recently released its new TSCA “systematic review” method that establishes how the Agency will use science to make decisions about whether to limit toxic chemicals in our air, water, food and everyday products. Unfortunately, our analysis finds that instead of ensuring a comprehensive, unbiased evaluation, like a systematic review is supposed to do, the TSCA method will severely narrow the science the Agency considers, leading to poor decisions and putting the public’s health at risk.

The method lays out the ‘rules’ EPA will use to find, assemble and interpret scientific evidence on chemical hazards and health effects. What studies EPA considers, and how EPA evaluates those studies can change the final conclusion about whether or not a chemical poses risks. Thus the ‘rules’ have profound implications for public health– especially for populations like pregnant women and children who are more vulnerable to chemical exposures. In particular, a serious concern with the TSCA approach is that it will result in relevant, high-quality studies being excluded from the Agency’s consideration.

Systematic review methods (such as Cochrane) are the standard for evidence evaluation in clinical medicine because they are demonstrated to save lives and money by providing a comprehensive, unbiased evaluation of the scientific evidence. Building from the clinical sciences, there are established, empirically-based methods for systematic review in the environmental health sciences that are validated, peer-reviewed and demonstrated in case studies over the last decade. These include the National Toxicology Program’s OHAT method and the Navigation Guide, developed here at UCSF. Of course we think the Navigation Guide is pretty great, but don’t take our word for it—the National Academy of Sciences (NAS) reviewed both methods and found them to be scientifically robust and exemplary of the type of systematic review method EPA should utilize in chemical evaluations.

What is particularly dismaying about the TSCA method is that it ignores the best practices for systematic review that have already been rigorously tested and validated– a waste of money and time. It is inconsistent with all the current methods for systematic review, which are informed by decades of research and development; the TSCA method is a far departure from OHAT, the Navigation Guide, and the recommended NAS approach.

First, the TSCA method is incomplete- it covers 2 of the 9 required steps, as shown in the diagram. An especially critical missing step is “Develop protocols for systematic review” which must occur prior to identifying and evaluating the evidence to ensure an unbiased review. Further, EPA’s regulation for risk evaluations also requires this—it mandates that the Agency use “a pre-established protocol” to conduct assessments.

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Adapted from The National Academies Press (2014) Review of the EPA’s IRIS Process

Second, the TSCA systematic review method sets up an unscientific ‘scoring’ scheme for evaluating study quality by assigning numerical scores to various study components, such as exposure characterization, and then calculating an overall “quality score.” The NAS, Cochrane methodology, and the academic community have already found based on analysis of empirical data that this type of ‘scoring’ approach does not measure actual study quality, and can lead to biased, inaccurate results. Further, EPA has chosen to score numerous study components that have nothing to do with the quality of the underlying research, such as how completely the authors reported the methods used to carry out the study.

Even worse, the TSCA method then uses this scoring scheme to inappropriately exclude studies based on a single reporting or methodological limitation, saying these studies are ‘unacceptable for use.’ The TSCA method’s arbitrary, unscientific scoring and exclusion of studies is right in line with other attempts to restrict the science EPA relies on, such as the recent “censored science” proposal from former Administrator Pruitt. And, we have a preview of how application of the TSCA method will throw out science—EPA applied the TSCA method in its evaluations of persistent, bioaccumulative and toxic chemicals, resulting in exclusion of almost 500 studies because they “did not meet evaluation criteria.” Excluding relevant studies can only result in a biased evaluation and inaccurate conclusions.

The point of a systematic review is to evaluate the entire body of scientific evidence, not exclude relevant science— no valid systematic review method excludes studies in this way and the TSCA method is far outside the scientific mainstream in this and many other respects. EPA needs to scrap the TSCA method and employ an existing empirically-based method (such as OHAT or Navigation Guide) that has already been tested and approved by the NAS. True systematic reviews are comprehensive, transparent, and unbiased and would help the Agency make the best science-based decisions to ensure protection of the environment and human health.


This post was co-written by Veena Singla, PhD, Associate Director of Science & Policy at PRHE. Public comments on EPA’s TSCA systematic review method were written by Patrice Sutton, MPH, Research Scientist at PRHE.

 

Pruitt’s War on Science Just Got Real

EPA Administrator Scott Pruitt just released new proposed regulations that he claims will ‘strengthen science’ and address the ‘replication crisis.’  But let’s be very clear, these regulations will only serve to undermine scientific evidence and contribute to the real crisis here—unraveling public health protection in the U.S.

The rulemaking is based on prior proposed legislation in Congress oxymoronically named “The Honest Act”, but there was nothing honest about it—a more fitting name would be the “Dishonest Honest Act.” The legislation attacked what it called “secret science” and proposed bringing more transparency to the science forming the basis for EPA regulations. But what does Pruitt really mean when he says research should be more “transparent”? The rule proposes a requirement to share any underlying scientific data used in the development of regulations. In essence, this can eliminate studies the industry doesn’t like because the underlying data are not publicly available.

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You may ask yourself, well why not just share the data? Data sharing and access is indeed an important aspect of the scientific process. NIH, other agencies, and scientific journals all have data sharing policies to ensure that data is open and accessible for scientific purposes. Additionally, scientists publish their methods, including how they obtained and analyzed their data as part of the transparent scientific process. However, research related to health involves people. People participate in our studies because they want to advance science and with the understanding that their information will be kept confidential. Would you be part of a study if all of your private information were shared with the government, or the industry who is opposing limits on pollution? What about your home address? Health studies routinely collect data that involves private information that should be protected, and not made publicly available.

Then, you may say, why not just redact the data to remove any personal identifying information? Sounds easy enough—but it isn’t. Redacting information about participant’s home addresses, diseases, household income, and other identifying information is cumbersome and costly. Studies involving rare diseases can mean that no matter how much information is redacted, individual participants can still be identified. This places a heavy burden on scientists to protect the personal information of their study participants in order for their data to be used to inform environmental regulations, something that they won’t receive funding or incentives to do. But the chemical companies will be incentivized to redact and provide their data—the same chemical companies that don’t have studies that demonstrate that exposure levels are safe and that their chemicals don’t pose health risks.

But wait… there’s more.  Like an industry Christmas list, this proposed rulemaking is full of wish list items reflecting how industry wants science to be conducted. For example, the regulation promotes the use of ‘Good Laboratory Practices,’ something scientists have said inappropriately weights these studies which often use old scientific methods over academic studies. They even propose to legislate what science EPA should use in determining the relationship between exposure and health effects. In short, these are all efforts to give industry what they have been after for decades—to create doubt in the science and use it as an excuse to ignore studies that don’t give the “right” answer, all in the name of “transparency.” Last we checked, the mission of the EPA was to “protect human health and the environment,” but these proposed regulations will almost certainly have the opposite effect.

Juleen Lam, MH, MHS, PhD, co-wrote this post. She is an Associate Research Scientist on the Science & Policy Team at PRHE.

Research program benefits kid’s health; funding in jeopardy

The Children’s Health Protection Advisory Committee (CHPAC) sent a letter to EPA Administrator Scott Pruitt praising the innovative science carried out by the Children’s Environmental Health and Disease Prevention Research Centers across the country and supporting continued funding for their vital work which contributes to reducing health risks and improving the quality of life for children.

A unique federal partnership between US EPA and NIEHS invested more than $300 million in grants to Children’s Centers since 1998. The return on this investment has been enormous; considering just one impact that science from Children’s Centers informed, the National Ambient Air Quality Standards for ozone, yielded estimated net health benefits up to $2.8 billion in 2014.  This number reflects the real benefits that accrue to every day families, such as seen in findings from the University of Southern California that better air quality is associated with improved lung function and bronchitis symptoms in kids.

As summarized in a new report, research at these Children’s Centers identified the critical role that toxic environmental exposures play in asthma, obesity, ADHD, cancer, autism and other childhood illnesses. This research has led to new detection, treatment and prevention strategies for such diseases, often with a focus on vulnerable and underserved communities. It is essential to fund the Children’s Centers program so we can continue to learn about environmental hazards that harm children and then take steps to prevent them.

Children’s Centers have led to an improved understanding of the environmental impacts on child health and development.

National Academies of Sciences

For example, the Emory University Children’s Center researches disparities in birth outcomes for African American women in Atlanta, investigating the effects of chemical exposures, stress and the microbiome. With its community advisory board, the Center produced a short documentary film focusing on environmental health concerns that are relevant, accessible and culturally appropriate for expectant African American mothers.

Research from a Duke University Children’s Center contributed to EPA’s science assessment of lead, which was the basis for establishing National Ambient Air Quality Standards for this toxic metal. Such policies are a vital step in halting the detrimental effects of low-level lead exposure on children’s health.

Pioneering work from our UCSF Children’s Center to embed environmental health in medical education was recently featured in the New York Times. Our Center also led efforts to educate and engage women’s health professionals—the American College of Obstetrics and Gynecology and the International Federation of Gynecology and Obstetrics have all called for action in clinical care and health policies to prevent harmful environmental exposures. These are important steps towards filling what Dr. Hanna-Attisha, the pediatrician who uncovered lead poisoning in Flint, Michigan, sees as one of the largest deficits in medicine today– the omission of environmental factors when doctors talk to patients about their health.

The Children’s Centers program is exceptional because their research uses an interdisciplinary, collaborative approach and most importantly, has an intentional focus on translation of research findings into applied intervention and prevention methods at the family, community and policy levels. Funding this program is a proven and wise investment in a healthier future for our children.


AMC picAnnemarie Charlesworth, MA co-wrote this post. She is the Director of the Environmental Health Initiative and Director of the Clinical Outreach and Translation team at PRHE.

EPA Advisory Panels – Experts Need Not Apply?

Scott Pruitt, the head of the Environmental Protection Agency (EPA), recently implemented a new policy banning scientists who receive EPA grant money from serving on its advisory committees. In many cases, independent university scientists, who are leading experts in their fields, will be replaced with advisors funded by the oil, chemical and waste disposal industries—the very industries EPA is supposed to regulate to protect public health.

Stacking these panels with industry players puts the public’s health at risk because it undermines EPA’s ability to make sound, science-based decisions without undue influence from those who stand to profit from EPA’s decisions.

There are a number of different committees that advise EPA. A particularly important one is the Science Advisory Board (SAB), charged with peer reviewing the scientific basis of EPA’s policy decisions on environmental pollutants. While many reports have focused on how Pruitt’s policy affects the SAB, the policy affects all EPA advisory committees, including the Children’s Health Protection Advisory Committee (CHPAC). Removing top scientists who have critical public health expertise in favor of industry-funded advisors who have argued, amongst other things, that children are less vulnerable to toxic chemicals than adults – a view so far outside of mainstream science it is safe to call it patently false – is a not-so-thinly veiled attempt to shift the goal of EPA’s decisions from protecting health to protecting industry sales.

Pruitt’s advisory board policy and attendant comments push the false narrative that scientists who receive federal grants try to advance a political agenda. This could not be further from the truth. As a scientist who receives federal grant money, I can attest to the rigorous peer review process every grant proposal must endure. This process ensures the scientific methods proposed are appropriate and sound, which is critical to creating an unbiased scientific study.  Additionally, reviewers evaluate the scientific expertise of the investigator applying for the grant – including whether the scientist is participating in the scientific process through publication of peer-reviewed science in respected journals. This ‘double vetting’ ensures that scientists of the highest caliber receive federal money to investigate critical questions relevant to environment, health and welfare using the proper approaches and methods. This process helps ensure that we have preeminent scientists carrying out EPA-funded research using current, innovative methods in an unbiased way.

Contrast this with whom Administrator Pruitt is proposing to put on panels: industry representatives he calls ‘financially independent’ from the Agency. This is twisted logic because these same representatives are financially dependent on industries, such as the chemical industry, that stand to make significant monetary gains if EPA weakens protections. Scientists paid by the chemical industry have a direct financial stake in the outcome of EPA policy decisions, and are not ‘independent.’ Indeed, documents from a recent court case against Monsanto show that ‘scientific experts’ were paid thousands of dollars to publish papers with outcomes predetermined by the company. These “studies” were then used to advocate for industry positions on the science, such as disputing the human health harms of toxic chemicals (see pp.127-129 of the document here).

Finally, notably missing from Pruitt’s appointees are representatives of those disproportionately affected by environmental chemicals, such as workers, tribes, and families from contaminated communities. PRHE made this point in comments to EPA twice this year.

While science has been under unprecedented attack at EPA there is good news. As Washington bows to industry, states and localities are starting to legislate their own bans on chemicals harmful to health, such as flame retardants. Scientific evidence confirms the health and economic benefits of clean air and water protections. And independent scientists and communities continue to document the effects toxic chemicals have on our health, such as deaths from the use of methylene chloride paint stripper or the increase in miscarriages and stillbirths in Flint, Michigan after the water supply became contaminated with lead.

These findings unmask the very clear connection between health and the environment. They also reveal why scientific integrity and independent science are vital to sound policy-making at all levels of government.

Protecting Science at EPA Means Defending its Budget

Over 100 scientists, clinicians and health professionals are telling Congress not to defund programs at EPA that are essential to protecting children and pregnant women’s health from environmental threats.

Funding and support for research to understand how the environment can impact children and the health of communities are more important than ever to provide evidence in the face of an anti-science and deprotection agenda.  The current leadership at EPA is continuing to make decisions contrary to the scientific evidence and counter to the Agency’s mission to protect public health and the environment. For example, fuel efficiency standards, designed to reduce greenhouse gas and other air pollutant emissions, are just one of 52 health and environmental protections the EPA has rejected or proposed to rollback under Scott Pruitt’s leadership. Each removal endangers our health.

Air pollution exposure can result in a host of adverse health conditions, including asthma, bronchitis, premature birth, heart and lung disease, and premature death. In re-opening review of the fuel efficiency standards, Pruitt and his industry-aligned appointees have ignored the science documenting the tremendous benefits the rule could provide, such as reducing premature death, asthma and respiratory diseases, especially for children. The standards are estimated to provide at least $5.9 billion per year in health benefits in 2040.

To provide critical data to the public and other decision makers in support of common-sense protections, the EPA needs access to the most up-to-date science and analyses on everything from how the Clean Air Act is working to evaluating and preventing health risks from harmful chemicals in commerce. The health of the public, especially those who are most vulnerable, depends on the EPA having enough resources because:

  1. EPA programs help protect children’s health from toxic chemicals in the air, water, home and other environments.
  • EPA’s Science To Achieve Results (STAR) programs that conduct the critical research on how the environment can affect children’s health, science that is not being funded anywhere else. For example, research supported by this program demonstrated that children are more vulnerable to toxicity and exposures from environmental chemicals, so chemical evaluations should incorporate child-specific considerations.
  • Programs to prevent lead poisoning and exposures in children and for environmental justice programs. Lead damages children’s brains and there is no safe level of exposure. As the ongoing Flint water crisis demonstrates, it is vital that these programs are resourced to function properly at the federal, state and local levels.
  • Local programs that monitor the quality of the air, water, and soil help ensure healthy communities. Families and communities need know whether their community is free of dangerous levels of contaminants that threaten them and their children’s health. This only happens when there is data to understand where and when exposures occur. Documenting chemical levels after hazardous leaks and spills caused by the recent hurricane in Texas is just one example of why these programs are so important.
  1. EPA’s research and the Integrated Risk Information System (IRIS) program are critical to evaluate health risks from pesticides and chemicals and protect the public from those that pose unreasonable risks.
  • The EPA has enormous statutory obligations and responsibility to protect families from dangerous chemicals and yet less than 10% of high-volume chemicals in the US have exposure and health data. EPA research is critical to filling the gap and is particularly important to provide key data for the Agency to successfully implement the updated Toxic Substances Control Act, which Congress approved last year.
  • The IRIS program carries out independent assessments of chemicals, which are vital resources for local, state and national authorities to use in decision making on hazardous chemicals, including informing regulations and clean-up standards. Funding for the IRIS program is needed for EPA to move forward with chemical evaluations and to make science-based decisions as required by law.

We know from past administrations that when an agency like the EPA is cut, it can take decades before important programs are back up and running. EPA’s programs generate the data needed to inform sound, science-based policy decisions that protect the public’s health; thus it is vital to maintain EPA’s scientific and research capacities despite Agency leaders who choose to ignore the evidence.

Defend Science superheroes

EPA plans for calculating chemical risks just don’t add up

The United States Environmental Protection Agency (EPA) is making major changes in how it deals with hazardous chemicals, and the first 10 chemicals EPA is considering have a whopping combined production volume of over 1 billion pounds per year. That’s about 3 pounds of chemicals per person in the U.S., and we know that Americans are widely exposed to these chemicals — some taint our drinking water, others contaminate our homes, or waft from our dry-cleaned clothes.

As we wrote earlier this year, Congress recently overhauled the federal law, the Toxic Substances Control Act (TSCA), which is supposed to address toxic chemicals in everyday products like furniture, toys, building materials and cleaning products. One of the EPA’s first actions under the new TSCA is to evaluate risks to human health  (a process known as “risk evaluation”) for the 10 chemicals shown in the table below. These first 10 assessments are critical  because these chemicals are widespread in our homes and workplaces, and because these assessments will set the precedent for how EPA evaluates chemical risks for decades to come.

Table of the first 10 chemicals EPA is evaluating under the new TSCA with recent news stories where available.

Chemical Recent news stories
Asbestos Upended by America’s ‘third wave’ of asbestos disease (Center for Public Integrity)
1-bromopropane (1-BP, n-BP, n-propyl bromide) As OSHA Emphasizes Safety, Long-Term Health Risks Fester (New York Times)
Carbon tetrachloride (tetrachloromethane) Even though I’m an environmental reporter, the air quality in my home was eye-opening (Courier-Journal)
1,4-dioxane Cancer-Causing Pollutants Found In Westbury Water District Drinking Water, Study Shows (Hicksville Patch)
Hexabromocyclododecane (HBCD) Recycling plastics contaminate children’s toys with toxic chemicals (The Guardian)
Methylene chloride (MC, MEC, DCM, dichloromethane) Mother Questions Use of Chemical After Son’s Death (WebMD)
N-methylpyrrolidone (NMP)
Perchloroethylene (PERC, tetrachloroethylene) Vapor intrusion scare delays start for St. Paul school (Minneapolis Star Tribune)
Pigment violet 29
Trichloroethylene (TCE) Are Hazardous Vapors Seeping Into Your Home? (Ensia)

As these stories show, the stakes are high for communities in the U.S.; that’s why we’re concerned that EPA’s plans for analyzing these 10 chemicals’ risks (which EPA laid out in its “chemical scoping documents”) are missing key pieces. Without these pieces, EPA will not have the information it needs to keep families from being exposed to harmful chemicals.

For example, take the story of Kris Penny, who was exposed to asbestos at his job installing cables inside asbestos cement pipes. He contracted mesothelioma, a type of cancer caused by asbestos, and tragically passed away at age 40 in 2016. Such a scientifically clear and documented risk should be part of EPA’s evaluation of asbestos but as shown below in the snapshot from the scoping document, EPA specifically excludes considering exposures from asbestos cement pipes, amongst many other known uses of asbestos, from its risk evaluation plan.

AsbestosSource: US EPA, 2017. Scope of the Risk Evaluation for Asbestos. Pg. 24

By doing this, the EPA is basically subtracting workers like Kris Penny from its risk equation — a choice that is scientifically unjustified and fails to reflect the true risks of asbestos, particularly for those exposed at work. This problem is one of many in the EPA’s plan that will lead to underestimating risks — and unfortunately, the problems are not confined to asbestos. This pattern of excluding chemical uses and exposures that contribute to risk is also apparent in the plans for the other 9 chemicals under review.

In scientific and technical comments submitted to the EPA today, UCSF PRHE along with 24 other scientists and health professionals outlined several major concerns with EPA’s plans for evaluating chemical risks, including significant chemical exposures that are missing for workers, consumers and the general population. But how, and how much of, a chemical gets into people’s bodies – the chemical exposure – is just one part of the information that goes into EPA’s risk calculations. Our future blogs will focus on other important ways that EPA can make sure they use the best science on behalf of the American public.

EPA’s methods of accounting for chemical risks are too important to get wrong right out of the gate. The consequences of EPA’s decisions – for better or worse – will be borne by people like Kris Penny, and millions of other workers, families, and children for decades to come.

Colorful chemicals