PSR leaders and staff stood with other health professionals, scientists, academics and NGO representatives at the U.S. Environmental Protection Agency’s public hearing in Washington, DC to voice strong opposition to the EPA’s proposed rule, “Strengthening Transparency in Regulatory Science.”
Throughout the 12-hour-long hearing, the vast majority of speakers who testified raised concerns and criticism of the proposed rule.
PSR called for the proposed rule to be withdrawn on the grounds that it censors scientific research, has no scientific justification, and endangers human health. PSR voices delivering that message included national board member Alan Lockwood, MD, FAAN, FANA; Philadelphia PSR Executive Director Walter Tsou, MD, MPH; national staffers Barbara Gottlieb and Antonia Herzog, and interns Louisa Angly and Brenda Munive.
A primary concern was the requirement that EPA consider only those scientific studies that publicly released all of their underlying data. While that may sound reasonable, it creates a fatal flaw: Many of the best scientific studies draw on data from hospital records, or utilize live research participants. To release the full data set in those studies would illegally infringe on the privacy of study subjects.
As Dr. Lockwood pointed out, “Under the misleading veil of ‘transparency,’ the proposed rule could force investigators to invade the confidentiality of research participants and make confidential and private data open to all.”
He went on to note, “Protecting the privacy of research participants is a keystone of biomedical research.”
The other alternative—excluding robust, peer-reviewed studies from EPA consideration simply because they included personal identifiers—would, in Barbara Gottlieb’s words, “weaken the scientific record and undercut the accuracy and the strength of EPA’s regulatory process.” This, she noted, would severely jeopardize EPA’s ability to identify dangerous pollutants and protect the public from them.
Dr. Tsou observed that the rule would have rejected studies that exposed the detrimental effects of smoking tobacco on health or the existence of anthropogenic climate change. “If these transparency rules were in place when the EPA was founded, smoking would still be [allowed] in airplanes and no one would have heard of ‘greenhouse gases’ or ‘global warming,’ the greatest threat to our planet’s existence.”
The EPA also argues that data must be publicly released so that research can be replicated. Yet some of the most important health studies that inform regulations can’t readily be replicated or reproduced. This may be because the research spanned long periods of time, or was conducted in environmental conditions that no longer exist, such as dirtier air, or examined the impacts of a unique event that can’t be replicated, like an oil spill. One prime example is the Harvard Six Cities study that underpins the Clean Air Act.
Antonia Herzog stated, “If these studies were excluded by the EPA restrictions, it would greatly reduce the availability of information that has proved to be significant in assessing the consistency and coherence of the evidence upon which the standards are based.”
It was also difficult to ignore the undue influence that industry would gain if the rule were enacted. Brenda Munive remarked that with the exclusion of reams of academic research, “industry-funded research could comprise a disproportionate amount of what informs EPA policies, giving the industry, not the scientific community, a large degree of influence in shaping environmental protections.”
The danger in relying on studies conducted by industry was highlighted by Louisa Angly, who cited a review of research on the health effects of bisphenol-A. The review found that 94% of publicly funded studies found the chemical to have harmful effects, whereas none of the industry-backed studies found the chemical to have harmful effects. “This huge disparity in findings,” pointed out Angly, “could not have occurred due to chance alone.”
Other speakers called the rule a “solution in search of a problem,” noting that the EPA brought forward no evidence that the science it uses has suffered due to a lack of transparency.