The US Environmental Protection Agency (EPA) finalized a rule Tuesday that limits the use of scientific research that does not make public all data collected from the study.
The new regulation, titled Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information, does not automatically disallow the use of any data from confidential studies but creates a standard that requires the EPA to favor results from studies that make their underlying data publicly available.
In the language of the regulation, the EPA stresses that the action is meant to “help strengthen the transparency of the dose-response data underlying certain EPA actions and to set the overarching structure and principles for transparency of pivotal science in significant regulatory action and influential scientific information.” Dose-response data is used to analyze how an organism responds from exposure to specific chemicals and is regularly used for finding recommended levels of pollutants, dosages of drugs, and limits for levels of chemicals in foods, among other things. The new regulation creates another hurdle for allowing scientific research to be used in the creation of public policy and would allow the EPA’s Administrator to disregard results from certain studies that do not make their underlying data public and may even bar these studies from being published on the EPA’s website.
Although the emphasis on transparency of scientific data may be a beneficial change, and might, as the EPA claims, increase the availability of data for peer review of the “pivotal” science, the new regulation could ultimately impede the use of studies that use data from individuals’ private health histories or other data crucial to the study that could only be obtained under an agreement of confidentiality. Underlying data that is kept confidential does not bar a study from being peer reviewed or replicated.
Critics of the regulation claim that this is a step backward and that the EPA should encourage the use of all science available to them. This new regulation comes in the middle of the COVID-19 public health crisis, and many have pointed out that studies showing that air pollution increases the risk of serious health problems or death following infection by the coronavirus could be disallowed from being used to create future public health policy. Among numerous important studies that could be limited by this regulation, including studies that were used to limit levels of mercury in food, is a study published in March that helped guide recommendations of cleaning agents to kill the SARS-CoV-2 virus.
The regulation allows the EPA’s Administrator to exempt studies from this rule on a case-by-case basis. It is unclear how this new regulation will impact the incoming Biden administration’s EPA led by Michael Regan, or whether it will be repealed at some point during Biden’s presidency.
