New air pollution rules being pushed by the Environmental Protection Agency might come crashing down, thanks to some missing technical data.
When the EPA proposed its new rule on so-called fine-particle air pollution, it relied heavily on two studies that appeared to show a link between low levels of fine-particle pollution and deaths.Tens of thousands of deaths a year.
But nobody - outside of the researchers who did the studies - has seen the raw data.That's despite repeated efforts by scientists, industry, even the EPA - which helped pay for the research - to make it public.
This has upset some in the research community and industry.People in industry, in particular, think the research might be flawed. But they can't make their case without seeing the raw numbers.
Critics of the proposed new rules say that other air pollution studies haven't held up very well when independent researchers were able to look at the underlying data.
More important, the lack of access to the data could give industry groups legal grounds to challenge the entire rule in court.In a recent case, a U.S. District Court struck down a federal rule because the data supporting it weren't made public.
Backers of the EPA rule say this is all much ado about nothing.Numerous studies, both here and abroad, link particles in the air to serious, even fatal, health problems.And, the EPA's own panel of science advisers overwhelmingly agreed that a new standard for fine particles was needed.They just couldn't agree on the level.
But given the EPA's reliance on these two studies, the case of the missing data takes on real importance, others argue.At stake is costs to business that could reach into billions of dollars a year.
The EPA got this ball rolling on the day before Thanksgiving last year when it proposed a new standard for fine particulate matter, which spews from car exhaust pipes, industrial smokestacks, even backyard barbecues.
According to the EPA, these Fine particles are killers, causing tens of thousands of premature deaths each year.
But as soon as the proposed rule was issued, it sparked heated controversy.
Industry groups said the agency rushed to judgment - pushing a standard based on a handful of studies for which the data aren't publicly available.
EPA head Carol Browner insists the science backing up the new rule is rock solid."This has been the most extensive scientific review process ever conducted by EPA for public health standards," she told a Senate panel earlier this month.
But witnesses at a separate Senate hearing cast doubts on the science.
"Several studies that have reported significant associations between particulate matter and health have been reanalyzed" using the original data, Ron Wyzga, a scientist at the industry backed Electric Power Research Institute, said at the hearing.
"By and large," he said, "these reanalyses do not reach the same conclusions as the original studies."
For example, an air pollution study in Birmingham, Ala., suggested that more people tended to die on days with high pollution levels.But other experts looked at the same data and found that when humidity was included in the analysis, the health effect disappeared.
What does this mean?To some researchers it points to weaknesses in the science on the health effects of particulate air pollution.
"It's not that cut-and-dried," said Fred Lipfert, a scientist with the Brookhaven National Laboratory.
But scientists have not been able to do the same kind of reanalysis of the two key air pollution studies used by the EPA in pushing its new rule, because they can't get their hands on the data.
One of the studies is commonly called the Harvard Six Cities study.It compared air pollution and health in six cities in the U.S. over a period of many years.The 1993 study found that people in the most-polluted city were 26% more likely to die prematurely than those in the cleanest city.
For several years, attempts to get that study's underlying data have failed.
- Back in May 1994, the EPA's Clean Air Scientific Advisory Committee wrote Browner asking that she get "crucial data sets linking exposure to particulate matter and health responses." CASAC never received the Six Cities data.
- In November 1996, the Utility Air Regulatory Group filed a Freedom of Information Act request with the EPA for the Six Cities data.The EPA turned the request down, saying it didn't have the information.
- Last month, Mary Nichols, head of the EPA's Office of Air and Radiation, wrote Douglas Dockery and Joel Schwartz, the principal researchers at Harvard, asking them for the data.
As Nichols put it: "Given the strong interest in your research ... we request that you make data associated with your published studies available to interested parties as rapidly as possible."
Dockery and Schwartz wrote back to Nichols, saying that they had already planned to make the air pollution data - not the health data - available to a research group in Cambridge, Mass., as part of a bigger study on air pollution.
But that group, the Health Effects Institute, hasn't gotten the data yet. And, the research won't be publicly available until after the institute has completed its review, which could take years, according to Dan Greenbaum, head of the Health Effects Institute.
- Finally, on Feb. 5, House Commerce Committee Chairman Thomas Bliley, R-Va., sent a sharply worded letter to EPA head Browner noting that the agency has the right to get "the underlying data and supplementary materials for the studies" since it paid for the research.Bliley told Browner she should exercise her "authority to request the data."'
"The public must be given an opportunity to review all of these data," he said, "so that they can be confident that EPA is basing its decisions on sound science."
The EPA's Nichols answered the letter: "We do not believe ... there is a useful purpose for EPA to obtain the underlying data" since the studies were published in peer-reviewed journals.
"Securing more detail about this information is not necessary as part of EPA's public health standard- setting process," she noted.
Given the hoopla, why not just give up the information'?
Epidemiologists say it's not unusual for researchers to protect their data sets.
In a 1994 memo to the EPA, Harvard's Schwartz outlined some of the reasons, including "data privacy, as well as the fact that it takes great effort to put together the data, and the reward is that many subsequent papers are then "in the bank."
But another important reason, according to Schwartz, is the desire not to have to spend endless time arguing about a continuing series of industry reanalyses." Industry, he says, will always try to poke holes in research that makes it look bad.
That point irks many researchers.
"If you can take the same information and get an article published in a peer reviewed journal that comes up with a different answer, that's an important finding," Brookhaven's Lipfert said."That's the way science is supposed to work."
More than that, the inability of industry groups to get their hands on the data mighty science is supposed to work."
More than that, the inability of industry groups to get their hands on the data might give them grounds to challenge the rules in court.
A court could decide that the rule isn't valid, since the supporting data weren't available.Some say the court has already set a precedent.
In that case, a U.S. District Court ruled that the U.S. Fish and Wildlife Service improperly listed the California gnatcatcher as an endangered species because it failed to make certain data available to groups affected by the rule.
"Where an agency relies upon data to come to a rulemaking decision, it generally has an obligation under the Administrative Procedure Act to provide such data for public inspection," the court said.
Not everyone is convinced that such a legal challenge is possible.They note that several rules on the books are based on published studies for which the underlying data weren't available.
But others take a different tack.
"I think it (the gnatcatcher ruling) is suggestive of where the courts are," said C. Boyden Gray, former White House counsel under President Bush, who is working with the Air Quality Standards Coalition, an industry group fighting the rules.
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