For nearly a decade, a federal agency has been responsible for assessing the dangers that chemicals pose to reproductive health. But much of the agency's work has been conducted by a private consulting company that has close ties to the chemical industry, including manufacturers of a compound in plastics that has been linked to reproductive damage.
In 1998, the Center for the Evaluation of Risks to Human Reproduction was established within the National Institutes of Health to assess the dangers of chemicals and help determine which ones should be regulated. Sciences International, an Alexandria, Va., consulting firm that has been funded by more than 50 industrial companies, has played a key role in the center's activities, reviewing the risks of chemicals, preparing reports, and helping select members of its scientific review panel and setting their agendas, according to government and company documents.
We are unaware of any other instance in which nearly all of the functions of a public health agency have been outsourced to a private entity.
Environmental Working Group
The company produces the first draft of the center's reports on the risks of chemicals, including a new one on bisphenol A, a widely used compound in polycarbonate plastic food containers, including baby bottles, as well as lining for food cans.
The center's work is considered important to public health because people are exposed to hundreds of chemicals that have been shown to skew the reproductive systems of newborn lab animals and could be causing similar damage in humans. Chemical companies and industry groups have staunchly opposed regulation of the compounds and have developed their own research to dispute studies by government and university scientists.
The bisphenol A report, which some scientists say has a pro-industry bias, is a public document scheduled for review by the center's scientific panel on Monday. Employees of Sciences International involved in writing it will preside over the meeting.
Sen. Barbara Boxer (D-Calif.) and Rep. Henry A. Waxman (D-Los Angeles) in a Wednesday letter called for an explanation of the company's role and disclosure of its potential conflicts of interest before the panel convenes Monday. Boxer chairs the Senate's environmental committee and Waxman chairs the House's government oversight and reform committee.
Sciences International executives declined to comment to The Times, referring all questions to the National Institute of Environmental Health Sciences.
Michael Shelby, director of the federal reproductive health center, which is based in North Carolina's Research Triangle Park, also declined to discuss Sciences International.
But Robin Mackar, a spokeswoman for the National Institute of Environmental Health Sciences, which oversees the reproductive center, said Sciences International "has worked for the center since 1998 without any problems" and has participated in reports on 17 chemicals.
"These contractors have no decision-making or analytical responsibilities," she said.
But according to company and government websites and Federal Register documents, Sciences International is involved in management and plays a principal scientific investigative role at the federal center. The company has a $5-million contract with the center, according to an NIEHS document.
"The most significant project at our firm is the management of the National Toxicology Program's Center for the Evaluation of Risks to Human Reproduction," the Sciences International website says. It says half its clients are from the private sector, but its health studies are independent and it "is proud of its reputation for objective science."
Its current website contains no list of industry clients. But a 2006 version names BASF and Dow Chemical — which manufacture the plastics compound BPA — as well as DuPont, Chevron, ExxonMobil, 3-M, Union Carbide, the National Assn. of Manufacturers, and 45 other manufacturing companies and industry groups.
In 1999, Sciences International represented R.J. Reynolds Tobacco Co. in fighting an Environmental Protection Agency proposal to regulate a pesticide used on tobacco crops. In 2004, its vice president, Dr. Anthony Scialli, who is identified as the federal center's "principal investigator," co-wrote a study with a Dow Chemical Co. researcher on how to extrapolate data from animal tests to humans.
In addition, another Sciences International employee who works at the federal agency, Gloria Jahnke, has collaborated nine times on chemicals research with another company that gets funding from the plastics industry, according to a Times review of medical publications.
Sciences International's president boasted about its close collaboration with the federal reproductive health center, as well as the EPA and other federal agencies, in a letter soliciting R.J. Reynolds as a client in 1999.
Signed by company founder Elizabeth Anderson, the letter stated that Sciences International "serves the private sector, including many trade associations, on a wide range of health and risk assessment issues. However, we are different from most other consulting firms in that we also currently serve government agencies," which, the letter said, gives the company "a unique credibility to negotiate with regulators on behalf of our private sector clients."
The role of Sciences International in the federal center's work came to the attention of Environmental Working Group, a nonprofit advocacy group focused on environmental health, last month after some scientists who saw the report on BPA complained that it was biased toward the industry's position that low doses have no effect.
"We are unaware of any other instance in which nearly all of the functions of a public health agency have been outsourced to a private entity," wrote Richard Wiles, the working group's executive director, in a letter to the director of the NIH's National Toxicology Program, which runs the reproductive health center. "Questions about the objectivity and adequacy of this review process and the reviewers must be resolved before a final decision on BPA is reached."
Debate over BPA is one of the most contentious environmental health issues faced by government and industry. Traces are found in the bodies of nearly all Americans tested, and low levels — similar to amounts that can leach from infant and water bottles — mimic estrogen and have caused genetic changes in animals that lead to prostate cancer, as well as decreased testosterone, low sperm counts and signs of early female puberty, according to more than 100 government-funded studies. About a dozen industry-funded studies found no effects.
Fred vom Saal, a University of Missouri-Columbia scientist conducting NIH-funded BPA research, said the draft report written by Sciences International downplays the risks of the plastics chemical and makes critical mistakes.
"It's a combination of inaccurate information and blatant bias as it exists in its draft form," vom Saal said. "They specifically ignore fatal flaws in industry-sponsored publications." He said the 300-page report misrepresented government-funded studies that found effects by inaccurately portraying their findings, and failed to note industry funding of some studies cited.
Shelby, the center's director, in a late February memo to the Environmental Working Group, said Sciences International reviews the scientific literature on chemicals and writes the basic reports, but that conclusions are prepared by the center's panel of independent scientists, which "serves to minimize or eliminate any bias that might possibly be introduced by the contractor."
Shelby wrote that there are no requirements for Sciences International or other contractors to disclose financial conflicts of interest.
Mackar, of the National Institute of Environmental Health Sciences, said the chemical reviews are "all open and public" and "we're confident in our scientific panel."
But Vom Saal said that although the scientific panel includes many good, independent scientists, "none of them have expertise with this chemical."
A Federal Register document describing the center's creation in 1998 said scientists from Sciences International and the center "constitute a core committee" that "selects the expert panel membership and establishes the meeting agenda."
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