A new EPA rule will require confidential health records for scientific studies

According to a draft document obtained by the New York Times, the Environmental Protection Agency is seeking to implement a new regulation that would require any study used for EPA health and safety rulemaking to disclose all of its raw data, including confidential medical records.

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As part of its mission to protect public health, EPA sets standards for chemical safety and limits on pollutants in our air and water. These standards are based in part on the evidence provided by epidemiological studies.

Requiring confidential medical records from these studies would likely exclude from consideration many key studies underlying EPA’s anti-pollution regulations because researchers would be unwilling to release this information.

“[T]his proposal has nothing to do with transparency and regulation. … It has everything to do with dismantling regulations that have been in place for many years, that have been very effective at reducing pollution in the United States, and very effective in preventing disease that is caused by pollution.”

Philip Landrigan, a pediatrician and epidemiologist at Boston College and one of the world’s leading advocates for children’s health, warns that this a “dangerous” and “very badly misnamed regulation.”

“[T]his proposal has nothing to do with transparency and regulation,” Landrigan said. “It has everything to do with dismantling regulations that have been in place for many years, that have been very effective at reducing pollution in the United States, and very effective in preventing disease that is caused by pollution.”

When scientists conduct detailed studies on the public health effects of pollution, they typically measure the levels of air pollution in a city or town and then interview the local population, perform medical exams and lung function tests and perhaps even X-rays. All of this information goes into a computer for later analysis. The scientist’s goal is to correlate a given level of air pollution with the rate and type of disease in people.

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These studies have “established a whole series of important connections,” Landrigan explained. “They found that air pollution causes asthma in children. It causes an increased risk of heart disease, stroke, lung cancer and diabetes in adults.”

The doctors and the nurses who perform these studies promise the participants confidentiality, which is generally the case with medical and personal records of this kind.

The new “transparency regulation,” however, would require medical researchers to reveal all of the information on each individual in the study. “Ethical researchers are not going to do that,” Landrigan said. EPA will then say that a scientist’s promise to maintain confidentiality prohibits the results of that study from use.

“The whole scientific basis for the rulemaking will be dismantled,” Landrigan said. “This is a very dangerous [and] a very malicious proposal that’s coming out of the administration.”

In addition to affecting new studies on pollution, the new rule would affect one of the most influential public health studies ever done, the “Harvard Six Cities” study, which came out in 1993. Landrigan calls the Six Cities study “the foundational study that has related air pollution to chronic noncommunicable disease in the American population.”

“There have been other studies since that time that have confirmed the Six City studies findings, but the Six Cities study remains the bedrock of this whole regulatory body,” he explained. “While it’s true that the first paper was published back in the 1990s, the study continues to produce new information and it’s publishing new reports practically every year up until the present time.”

Related: Two recent EPA decisions threaten children’s health, experts say

The Six Cities study correlated levels of fine-particulate air pollution with elevated rates of heart disease, stroke, lung cancer, diabetes, and other diseases, including asthma in children and premature birth weight in newborn infants, Landrigan said. As the investigators have continued to delve into the data from this study, they have shown that air pollution causes negative health effects even at levels scientists used to believe were safe.

“That really bothers the regulated industries because those findings will require that levels of pollution be reduced. .. That means the industry is going to have to clean up its act. I think that’s why the industry lobbyists have gone to work and come up with this scheme to disallow, in the name of transparency, all the findings from the ‘Harvard Six Cities’ studies and from other similar studies that have been conducted across the United States.”

“That really bothers the regulated industries because those findings will require that levels of pollution be reduced,” Landrigan noted. “That means the industry is going to have to clean up its act. I think that’s why the industry lobbyists have gone to work and come up with this scheme to disallow, in the name of transparency, all the findings from the ‘Harvard Six Cities’ studies and from other similar studies that have been conducted across the United States.”

In any case, requiring scientists to violate confidentiality protections is unnecessary, Landrigan said, because there is already a system in place to validate the data underlying public health studies used by the EPA. Several years ago, researchers and EPA agreed to have an independent third party certify the confidential data.

Researchers from this third party, the Health Effects Institute, reviewed the records and confirmed that the records were accurate and that the science was sound, Landrigan said.

“There was no need to go any further, no need to reveal confidential records, and at that time, several years ago, the rule was left to stand,” he explained. “But now, the EPA is circling back around. They’re reraising this specter of transparency and essentially, they’re trying to gut the regulations.”

Landrigan has performed studies of children exposed to lead. In these studies, he collects detailed information on each child and family. If asked by EPA to turn over his raw data and disclose this information, he would refuse.

“I would honor my word to my patients. … But that would mean EPA would throw out the results of my study and they would decide not to use my data in making a regulation to protect children against lead poisoning.”

“I would honor my word to my patients,” he said. “But that would mean EPA would throw out the results of my study and they would decide not to use my data in making a regulation to protect children against lead poisoning.”

“And what I expect we’ll see happen if these regulations take effect is that levels of air pollution will go up. The consequence of that is people will die,” he stated. “More children will have asthma, more babies will be born with low birth weight, more adults will suffer heart disease, stroke and lung cancer and premature death as a consequence of increased levels of air pollution.”

“The regulated industries may get a little reprieve for a few years, but the burden of disease and premature death is going to fall on people across the United States,” he said. “There are no winners here, only losers — except for the regulated industries.”

This article is based on an interview that aired on PRI’s Living on Earth with Steve Curwood.