On January 5, the EPA released a new “transparency” regulation that has scientists and experts worried the federal agency has taken a page out of the tobacco industry’s playbook, leveraging the rule in a way that could harm both new and established environmental research, including COVID-19 data.
The rule, named “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information,” allows the EPA to favor epidemiological studies that do not utilize confidential health records or personally identifiable information when policymaking. However, these kinds of studies using personal health information are extremely common and have been the foundation of many widely accepted studies and environmental laws for years.
The first draft of the rule was published in 2018, but variations of it can be seen in the 2015 “Secret Science Reform Act” and 2017 “Honest and Open New EPA Science Treatment Act,” which both failed in the Senate. That being said, the underpinnings of the finalized 2021 rule can be traced back even further—all the way to the 1990s. Under mounting pressure regarding secondhand smoke, tobacco industry consultants searched for loopholes that would make it harder for the government to impose sanctions on tobacco products. The resulting strategy became an attack on the use of confidential personal data in epidemiological studies, with tobacco lobbyists calling it “secret science.”
The 2021 rule essentially sets up a hierarchy of studies to consider when decision-making and policymaking within the EPA. It allows the federal agency to disregard any epidemiological studies that have used study participants’ personally identifiable information since that specific data cannot be made public. Since natural controls are nearly impossible in the large epidemiological data sets needed for environmental research, the rule’s limitation of non-private dose-response data is a hardship that was not present before.
“You can’t go around dosing people with particulate matter to try to see the impact. The best way to look at approximating [pollution level] is a large study with lots of data points. Using people’s health information is the easiest way to have large data sets be useful while eliminating confounding variables,” a source at the American Chemical Society (ACS) told Laboratory Equipment.
This could create somewhat of a chilling effect among researchers, curbing or even discouraging the use of epidemiological data—the same type of data that has been the basis of many landmark clean air and water regulations passed in the last 50 years.
“The primary concern is that if you are going to start from the beginning to ensure your results could be used as broadly as possible, you’d have to deal with additional information security issues. Like going through the effort to make sure your large datasets are thoroughly scrubbed to make sure you follow both health data laws and this rule. It’s a barrier to using the data,” explained the ACS source.
According to The New York Times, the Trump administration has already used the rule to reject an EPA finding that the pesticide chlorpyrifos causes serious health problems.
“Right now, we’re in the grips of a serious public health crisis due to a deadly respiratory virus, and there’s evidence showing that air pollution exposure increases the risk of worse outcomes,” Mary Rice, a pulmonary and critical care physician who is chairwoman of the environmental health policy committee at the American Thoracic Society told the NYT. “We would want EPA going forward to make decisions about air quality using all available evidence, not just putting arbitrary limits on what it will consider.”
The finalized rule specifically states that it only applies to future regulatory actions and scientific information. Still, the fact that the 2021 rule would have prevented the EPA from using studies/data that showed mercury releases from power plants impair brain development and that cloudy drinking water is linked to higher rates of gastrointestinal illnesses illustrates how fundamental epidemiological studies (featuring private medical data) have been in past policymaking.
There is a high level of optimism among experts and scientists alike that this rule will be short-lived with the Biden administration entering the White House on January 20.
Congresswoman Eddie Bernice Johnson (D-TX), the chair of the House Science, Space, and Technology Committee, recently wrote a letter to President-Elect Joe Biden urging his administration to prioritize rolling back the rule. She went as far as saying the Trump administration may have violated the mandatory 30-day waiting period in their haste to finalize the rule before the end of their term.
“The EPA cannot be fully restored to its necessary role as a champion of the nation’s environment unless the Trump Administration’s worst initiatives to sabotage the Agency are swept away,” Johnson wrote in the letter. “[This] rule is designed to exclude critical science from EPA policymaking and to tie the Agency’s hands as it seeks to address our most pressing environmental challenges. I urge you to move swiftly on Day One against this rule, and to use all legal and administrative means at your disposal to do so.”