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The reviews rely heavily on published literature. The industry has argued that its research tends to be dismissed, putting pressure on the EPA to explain how much weight it gives each article. The EPA also has responded to criticisms that its chemical reviews have been cloaked in secrecy by holding more public meetings, which are dominated by industry scientists.
Gradient scientists have played an active role in trying to prevent tighter regulations.
In 2010, they helped delay for years the EPA’s review of arsenic, a substance most Americans regularly consume in water, rice, fruit juices and other foods. Agency scientists were about to report that arsenic posed a much greater health risk than previously thought, even at the amount the EPA currently allows in drinking water. They determined that for every 10,000 women exposed daily to the highest amounts of arsenic allowed by law, 73 eventually would get lung or bladder cancer.
Gradient scientists argued that the EPA left out the most recent research on arsenic and should redo the analysis. The omission was due mostly to delays by the Bush administration’s Office of Management and Budget, which had to approve all EPA scientific reviews. Some members of Congress latched on to Gradient’s argument to accuse the EPA of cherry-picking data. They twisted the agency’s arm to start the analysis over again.
The EPA was going to ban most uses of pesticides containing arsenic at the end of 2013. But without a scientific review, it had to postpone the ban indefinitely.
Gradient also helped persuade the Food and Drug Administration to declare another ubiquitous chemical, bisphenol A, harmless. That controversial decision was made in 2008. Nearly all Americans are routinely exposed to BPA in canned food, plastic bottles and cash-register receipts.
Hundreds of articles by academic scientists have linked BPA to health problems in humans, including infertility, diabetes, cancer and heart disease. In 2006, Gradient scientists published an article attacking dozens of academic studies that had reported reproductive problems in rats and mice fed BPA. The FDA cited Gradient’s article and a few industry studies in its decision.
Gradient maintained that humans are exposed to far less BPA than the animals in those studies. Frederick vom Saal, a University of Missouri professor who has investigated BPA for more than two decades, called that argument “complete nonsense.”
“You create a false statement of fact, and then you discount a whole literature,” vom Saal said.
A group of academic researchers were so outraged by an article on BPA written by Gradient’s Julie Goodman and Lorenz Rhomberg that they wrote a lengthy response with a table listing all the “false statements” in it.
“In this article, there is nothing that is true,” vom Saal said. “It’s ridiculous. And that’s how they operate.”
Rhomberg, who once worked at the EPA, now sits on a panel that reviews all of the agency’s toxic chemical assessments before they become final.
Adam Finkel, a senior fellow at the University of Pennsylvania Law School and a former official at the U.S. Occupational Safety and Health Administration, was close friends with Rhomberg for many years. He says he’s perplexed by how his friend seems to have changed since he joined Gradient.
“In 1997, Dr. Rhomberg submitted brilliant comments to our OSHA regulation on [the solvent] methylene chloride, in which he skewered a half-baked industry theory that the cancers it caused in animals were irrelevant to humans,” Finkel said. “Nowadays, I see him routinely cheerleading for some of the same sorts of unconvincing arguments designed to make substances seem less risky."
Asked to respond, Rhomberg said, “Open discussion about the evidence and how it is to be appropriately interpreted is essential to the scientific process, and any claims that paint as illegitimate the making of critical comments is destructive of the scientific process.”
Finkel is especially upset with arguments Gradient made in trying to prevent the EPA from listing a little-known chemical called n-propyl bromide as a hazardous air pollutant under the Clean Air Act. Gradient’s Goodman wrote a lengthy public comment in 2014 paid for by a maker of n-propyl bromide. In it, Goodman argued that a government study showing high rates of cancer among rats exposed to the chemical had no relevance for humans.
Finkel said Goodman offered no proof to support this but was “just making stuff up.” He said he found the document offensive because hundreds of workers are exposed to the chemical and some have suffered serious disabilities. In 2013, The New York Times told the stories of furniture workers in North Carolina who found it difficult to walk after being exposed to n-propyl bromide for only a few weeks.
Defending such a product, Finkel said, “is not your finest hour when you’re talking about something we know is killing people.”
Harvard ties
Gradient was founded in 1985, about the same time as two of its biggest competitors: Environ and ChemRisk. When the company was bought in 1996 by The IT Group, a hazardous-waste-disposal company, it was reporting annual revenues of $5 million. But Gradient was sold back to its founders in 1999 and no longer reveals its finances.
The company often touts its ties to Harvard. Several of its scientists used to be on faculty at the Harvard T.H. Chan School of Public Health. Some continue to teach there as adjunct faculty.
Gradient’s clients include two of the most powerful lobby groups in Washington, the American Petroleum Institute and the American Chemistry Council. Other frequent clients include Navistar, a diesel truck manufacturer, and the Texas Commission on Environmental Quality, a regulatory agency that has a history of aligning with industry.
Gradient has become a leading scientific voice in trying to prevent further regulation of air pollution. That puts its scientists at odds with former colleagues at the Harvard School of Public Health, such as Dockery.
Dockery was among a team of scientists at Harvard who after the Arab oil embargo in 1973 set out to evaluate the health effects of burning domestic coal instead of foreign oil to generate power. With funding from the National Institutes of Health, the Harvard scientists recruited more than 8,000 volunteers in six cities living near coal-burning power plants. Monitors were used in each city to measure soot and smog.
After collecting data for 15 years, the researchers themselves couldn’t believe what they were finding. People who lived in communities with the dirtiest air died on average two years younger than those who breathed cleaner air. That meant that eliminating air pollution could increase life expectancy in some cities to the same degree as if scientists had found a cure for cancer.
The results of the Six Cities Study were so dramatic that researchers decided they couldn’t publish them without corroboration, Dockery said. The Harvard scientists were able to convince the American Cancer Society to share data on the health of 1.2 million volunteers tracked since 1982. The researchers matched it to EPA data on soot and came up with similar results.
For a while, the studies attracted little attention. But that changed in 1997 when the EPA — under pressure from courts to enforce the Clean Air Act — used the studies as the basis for new air-pollution rules.
According to the EPA, none of its regulations saves as many lives as the Clean Air Act. The agency estimates that in 2010, rules on soot and smog kept 164,000 Americans from dying prematurely, mostly from heart attacks. By 2020, it expects the number of lives saved annually to rise to 237,000.
But the regulations are expensive. The EPA estimates that industry will have spent a total of $65 billion on pollution controls by 2020.
