There are more than 80,000 chemicals on the market today. You might think that the government tests each chemical to assure that it's safe. But in the United States, unlike the European Union, chemicals are assumed to pose no health risk unless the EPA proves otherwise. This task is left to a small program within the EPA called the Integrated Risk Information System, or IRIS.
It may not be the sexiest job at the EPA. But the agency needs IRIS's scientific research to regulate chemicals. Without the science, there cannot be new regulations.
During the Bush years, the chemical industry had allies within the White House. Starting in 2004, EPA scientists had to submit drafts of their scientific assessments to the White House’s Office of Management and Budget for review. There, most assessments languished or died, according to an investigation by the Government Accountability Office in 2008.
Jackson announced she was wresting control of chemical assessments from the White House. In addition, she wanted to drastically cut the time spent on each one. The few reports that were getting published were taking an average of seven years to complete. She vowed to complete them in less than two years.
Yet, almost immediately, the chemical industry found ways to thwart Jackson's plan with the help of Republicans in Congress. Although the GOP didn’t control either chamber in Obama's first two years, Republican lawmakers still found ways to delay science at the EPA.
For example, the Senate has a gentleman’s agreement that a single lawmaker can stall a president’s political appointments. Sen. David Vitter of Louisiana did just that in 2009. He put a "hold" on a key EPA appointee until the agency agreed to get a second opinion on its formaldehyde assessment.
Formaldehyde is commonly thought of as an embalming fluid. But it's widely used in building materials, automobiles and even no-iron shirts. According to the National Academy of Sciences, we are all exposed to formaldehyde every day.
EPA scientists began evaluating the chemical in 1998 and determined that it was linked to nasal cancers and leukemia. They were not alone. In 2006, the International Agency for Research on Cancer, part of the World Health Organization, classified formaldehyde as a known carcinogen. In 2011, the National Toxicology Program of the U.S. Department of Health and Human Services did the same.
Yet, the formaldehyde industry, with its political muscle, challenges these findings. "The scientific literature is clear that there is no increased health risk from low-level exposures normally found in home or work environments," says a statement from the American Chemistry Council, a trade association and lobby group for the chemical industry.
One of formaldehyde's makers, Georgia-Pacific, is owned by Koch Industries, run by billionaires Charles and David Koch, two of the largest political donors in recent years.
To unblock the appointee, who would oversee the IRIS program, the EPA agreed to have the National Academy of Sciences review its formaldehyde draft. The academy, a fraternity of leading scientists, is the nation's premier scientific advisor.
But the panel of scientists assembled by the academy in 2011 didn't focus on whether the EPA was right about the science. Instead, it criticized the formaldehyde draft for being confusing and made suggestions on how to make future IRIS reports clearer. The chemical industry pounced on this.
When Republicans regained control of the House of Representatives in 2010, they could exert control over the EPA with spending bills. Even with gridlock in Washington, Congress has to pass such bills if it wants to keep the government open. This allows leaders of the appropriations committees to insert language anonymously for pet projects and special interests.
Last year, the Center for Public Integrity revealed that Rep. Mike Simpson, R-Idaho, inserted language to block the IRIS assessment of arsenic. Arsenic is commonly found in drinking water. EPA scientists were going to say in the assessment that for every 100,000 people who drank the allowable limit of arsenic every day, 730 would eventually get lung or bladder cancer from it.
But mining, power and pesticide companies all have a financial stake in arsenic. The EPA had an agreement with two pesticide companies to take a weed killer containing arsenic off the market because of the dangers. But the agreement was conditioned on the EPA completing its scientific assessment.
"I have to say that I'm not a lobbyist. I'm a scientist. When the EPA [reached its conclusion]… we found that there's a lot of flawed science in it. We had to get some help," said Michal Eldan, vice president of one of the pesticide companies, Luxembourg-Pamol. The other is Drexel Chemical Co.
The pesticide companies lobbied Simpson to stop an EPA ban of their products. In 2011, Simpson used his position on the appropriations committee to instruct the EPA to seek a new review from the National Academy. At that point, the EPA had been working on its assessment for seven years. As a result of Simpson's delay, the EPA couldn't enforce its ban and the herbicide remains on the market.
William Ruckelshaus, who ran the EPA for presidents Richard Nixon and Ronald Reagan, said getting the National Academy to review the agency's scientific findings is a common delay tactic used by industry. He sharply criticized it for endangering public health.
"Anytime that a scientific group or the EPA or any other agencies that has regulatory authorities over these kinds of chemicals finds something wrong it ought to be immediately published," Ruckelshaus said. "To the extent that that’s delayed or stalled in some way it’s really unconscionable — particularly if it’s done on behalf of the industry that manufactures the chemical and they have economic benefit associated with it."
The formaldehyde industry used the same delay tactic as the pesticide companies and at the same time. They even used the same lobbyist: former EPA official Charlie Grizzle.
Leveraging the National Academy’s criticisms about the clarity of the formaldehyde assessment, Grizzle and others got language inserted that delayed all 47 chemical assessments in progress. Here's how they did it: They instructed the EPA to adopt the academy’s recommendations and explain to Congress how it was going to implement them for ongoing and new assessments.
In an interview, Grizzle acknowledged he was involved in lobbying for the changes. Asked whether this forced the EPA to redo all of its assessments, he said, "I don't know."
For each chemical, EPA scientists start by reviewing hundreds of published scientific articles. Until now, they have relied on their expert opinions to decide which studies are the most reliable. But the National Academy recommended the EPA create a system – like a scorecard – to determine how much weight to give each study. EPA scientists complain that scoring hundreds of studies can be difficult and time-consuming.
Bernard Goldstein, an EPA official during the Reagan administration and the former dean of the University of Pittsburgh Graduate School of Public Health, said it's not clear that the National Academy's suggestions will produce better assessments. There’s little scientific dispute that some chemicals are toxic. The EPA may be spending much more time to arrive at the same conclusion as it would have before. The suggestions "could actually prolong the process and contribute to the problem that process was taking too long because you would need additional scientific analyses," Goldstein said.
Jonathan Samet, who chaired the National Academy panel on formaldehyde, defended its suggestions, saying a scorecard approach "has really become best practices in science."
But Samet, who also chairs the Department of Preventive Medicine at the University of Southern California, said, "We were quite clear that neither the formaldehyde or other assessments should be stopped or greatly delayed while changes were made to the process. There are too many important agents being evaluated and too many stakeholders awaiting results."
Ironically, the National Academy released its own assessment of formaldehyde last year. It agreed with the EPA's findings that formaldehyde is a known carcinogen linked to leukemia. The EPA formaldehyde assessment is still mired in delays, 17 years after work on it began.
Fans of Ken Olden
The Obama administration could have resisted political pressure from the chemical industry and House Republicans. The language instructing the EPA to seek second opinions from the National Academy was not in the spending bill itself. That language was put instead into a document attached to the bill to explain Congress's intent.
When shown the language, Charles Fox, who served as an EPA official during the Clinton administration, said, "This is what we consider advisory language. The agency is not obligated to implement that language in the report but is, for lack of better word, strongly encouraged to do so."
Lisa Jackson left the EPA in February 2013 and went to work for Apple. She did not respond to requests for an interview. Neither did her replacement as EPA administrator, Gina McCarthy.
In July 2012, Dr. Kenneth Olden took charge of the EPA’s National Center for Environmental Assessment, which oversees IRIS. While a director at the National Institutes of Health, Olden raised eyebrows by collaborating with the American Chemistry Council to fund scientific research. Olden has embraced the procedural changes sought by the National Academy of Sciences. In doing so, he has won praise from the chemical industry and Republicans.
Appearing before the House Committee on Science, Space and Technology last July, Olden was lauded by Republican congressmen who are usually critical of the EPA.
"I had some folks who care very much about what is done here, and they actually said nice things about you, Dr. Olden," said Rep. David Schweikert of Arizona. "You have no idea how rare it is to hear nice things about anyone around here."
Rep. Paul Broun of Georgia has called for the elimination of the EPA. But at the hearing, he said, “Dr. Olden has been a refreshing ambassador for the IRIS program and I applaud his commitment to an open and transparent IRIS process that includes early communication and increased opportunities for meaningful stakeholder input.”
Michael Walls, a lobbyist for the American Chemistry Council, testified, “You can count me among the fans of Ken Olden.”
In a case of role reversal, it was a Democrat on the committee who challenged Olden. Rep. Suzanne Bonamici of Oregon said that the EPA’s focus “on building a better relationship with industry has had the effect of crippling IRIS rather than putting the EPA on the path to streamline production of IRIS entries.”
Currying favor with Republicans may have saved IRIS from threatened budget cuts. In the most recent spending bill, Congress cut the EPA’s budget by $60 million. But it spared the IRIS program.
One of the biggest changes Olden has made is to hold public meetings every two months to get input on ongoing chemical assessments. An analysis by the Center for Public Integrity found that those meetings are dominated by speakers paid by the chemical industry. Since the meetings began, 85 percent of the speakers have been industry-funded scientists.
At the first public meeting in 2012, Richard Denison of the Environmental Defense Fund said, "It may seem strange to hear this from a representative of the public interest community, but what IRIS needs is fewer, not more, opportunities for ‘public’ input... More opportunities for input not only require more time, they also result in a process that virtually ensures the input received by EPA is imbalanced and badly skewed toward the regulated community."
Jennifer Sass, a scientist at the Natural Resources Defense Council, regularly attends public meetings on chemicals. She said it's not unusual for her to be the only scientist there not paid by industry.
"There’s a lot less scientists and community members that have the resources and have the interest and have the time to travel and take the time,” she said. “Whereas, the industry people are getting paid; every hour they are there, that’s a paid hour for them."
That leads to biased meetings, Sass said.
"I have never seen the chemical industry say, ‘Oh, wow! It looks from all of these data and the public literature like we had better start being safer with this chemical.’ They, in my experience, have always defended their chemical, tried to show that it’s safer, or less toxic, than what independent studies show."
At the most recent public meeting, Nancy Beck, a scientist at the American Chemistry Council, asked an IRIS scientist to present more information from all the studies the EPA reviewed.
“I know it’s a lot of work in the beginning,” Beck said about the scorecard approach.
IRIS scientist Catherine Gibbons replied, “I think it’s an extremely laborious process.”
Beck declined a request for an interview.
Olden himself acknowledged that the views at the meetings are not balanced. In October, he announced plans to bring in more independent scientists. Two weeks later, at a public hearing on hexavalent chromium, a chemical whose carcinogenic effects have been publicly debated since the film Erin Brockovich, every non-EPA speaker on the agenda was paid by industry.
Obama did not mention scientific integrity in his second inaugural address. Nor has he spoken about it lately. On its website, the IRIS program has removed Lisa Jackson's plan to take politics out of the process and replaced it with a new plan to address the concerns pressed by the chemical industry and House Republicans.
After months of requests for an interview, the EPA made Olden available to a Center reporter for 10 minutes by phone. He defended his emphasis on improving the quality of assessments rather than on Jackson’s promise to increase the quantity.
"You can’t hold me accountable for what happened years ago," Olden said. "I was brought in in July 2012 to address the issues that had been raised by GAO and the NAS report, and we are addressing those as rapidly as possible."
Olden had no explanation for why the EPA didn't resist pressure from Congress to delay assessments, saying that wasn't his decision.
"It more or less dealt with a policy issue in the regulatory arena that we don’t in fact deal with. That’s my position."
When asked if that decision was made higher up within the EPA, Olden said, "I stick with my answer."
He acknowledged that he gets pressure from the chemical industry but said, "We get pressures from lots of quarters, and to be balanced, you should point that out... But our commitment is to stick with the science. And you’ve never had any evidence that we’ve deviated from that during my tenure as director of this program, and you won’t find any evidence of that."
Asked why IRIS isn't producing more chemical assessments, Olden said, "We are doing as much as humanly possible. I think the agency is pleased, and I think the scientific community is pleased. I feel good about what we’ve done.
In his 2 ½ -year tenure, the EPA has published only four chemical assessments.
The University of Maryland’s Steinzor, an expert in scientific integrity, testified before Congress that the changes the EPA is making to IRIS are misguided.
"EPA's political appointees seem to harbor the naïve idea that this process will placate its critics,” she said. “Instead, endless jawboning has left the agency vulnerable to cynical exploitation. In sum, let us not lose sight of what is really at stake, the priceless notion that the water we drink and the air we breathe ought to be clean and healthy."