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Attack on FDA and EPA Integrity

by Brian R. Hill

Poison Maker Appointed
to Head EPA Region 10

U.S. EPA chief Stephen Johnson, under fire from his own staff scientists for chemical industry collusion, has named a major industry player as head of EPA’s Region 10, comprising Alaska, Idaho, Oregon and Washington. Elin Miller, previously with Dow Agrosciences and more recently President and CEO of Arysta LifeScience North America, will now oversee environmental protection of some of the most ecologically sensitive areas of the nation.

While at Dow, Miller chaired Responsible Industry for a Sound Environment (RISE), an industry-supported “Wise Use” group that promotes pesticides at the community level. She also served on the board of CropLife America, the primary agrochemical industry lobbying organization that helps funnel funding to congressional candidates to gain influence on chemical and pesticide policy.

At a speech Miller gave in April 2006, she spoke about Dow’s “investment” in a community in India, where the multinational corporation had built a classroom. She failed to mention Dow’s refusal to take ongoing responsibility for cleanup, medical care and community rebuilding in Bhopal. The 1982 explosion of Union Carbide’s pesticide plant, the worst industrial accident in the history of the world, continues to afflict suffering and death on thousands of Indians. Union Carbide has long since become a subsidiary of Dow, yet despite court orders and the ongoing International Campaign for Justice in Bhopal, Dow admits no liability and the plant remains abandoned, a rusting toxic memorial, with leaking pesticide containers strewn across the landscape.

Arysta, Miller’s immediate prior employer, is continuing to apply to U.S. EPA for registration of methyl iodide, a highly cancerous fumigant, as a replacement for methyl bromide in agriculture. Public health and environmental protection advocates in the Northwest U.S. are understandably concerned about this new “fox in the henhouse,” though the appointment of a polluter to regulate pollution is hardly novel.

The summer issue of this magazine reported on the assault on scientific quality at the U.S. Environmental Protection Agency, compelling EPA scientists to take the unusual step of publicly criticizing the agency’s work, especially the recent rush to complete the decade-long implementation of the Food Quality Protection Act. In this issue we report on the wider and growing assault on the integrity of government scientists’ work.

A prominent sign of this attack is the aggressive shutdown of EPA’s headquarters library and many of its branch libraries. EPA made a formal announcement of its headquarters library closure on September 20th, just days before the complete shutdown took effect.

Even in the age of the Internet, libraries and librarians are irreplaceable. Margaret Robbins, Director of London’s Centre for Corporate Accountability, and a former user of the EPA’s branch library in Chicago, explains, “a heap of documents found via a Google search is not the same as a skilled search by a librarian who knows what he or she is looking for. This will put lots of information effectively out of the public knowledge, and out of EPA staff knowledge, too.” Alarmingly, the EPA has no specific plans for making available on the web documents that were only available at its libraries.

EPA’s library closures sparked at least some Congressional scrutiny. Ranking members of the House Committees on Science, Energy & Commerce and Government Reform—Representatives Bart Gordon (D-TN), John Dingell (D-MI) and Henry A. Waxman (D-CA)—asked for an investigation into the effects that these closures will have on access to environmental information and the impacts on scientific research, regulatory quality and enforcement capability. Despite this concern EPA went ahead with the closure of its headquarters library to the public. As we went to press, seventy-five members of Congress, including Senators Barbara Boxer, Bill Nelson and Representative Hilda Solis, have demanded an explanation for the library closures from EPA administrator Stephen Johnson.

The assault on government science involves the Food and Drug Administration as well. Despite the FDA’s strong mandate to protect the purity and safety of America’s food and drug supply, there is clear evidence of inappropriate interference in FDA science. The Union of Concerned Scientists (UCS) and Public Employees for Environmental Responsibility (PEER) conducted a recent survey of almost 6,000 FDA scientists to which almost 1,000 scientists responded. Approximately 400 scientists reported that they feared retaliation for raising safety concerns in public. Over 180 of the scientists responded that they “have been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or their conclusions in a FDA scientific document,” and 700 scientists responded that the FDA does not have sufficient resources to effectively perform its mission of protecting public health.

Such inappropriate pressure on scientists and hampering of their mission to protect public health is present in other U.S. government departments as well. The UCS found a similar situation at the National Oceanic and Atmospheric Administration Fisheries and the U.S. Fish & Wildlife Services.

To add to these worrying trends is the issue of political appointees to high-level government positions—such as the appointment of pesticide industry insider Elin Miller as the Administrator of EPA Region 10 (see box on right). Without adequate safeguards, such political appointees can interfere in the work of government scientists entrusted with protecting public health.

There is no guarantee that the next U.S. administration will reverse these trends. Michael Halpern of the UCS recommends that reforms be put in place so that no future U.S. president interferes in the scientific process the way the Bush Administration has. The UCS reforms include requiring openness in FDA’s science so that undue manipulation is apparent and requiring safeguards to protect those scientists that speak out. Even the normally reticent National Academy of Sciences has joined the fray with its own series of reform recommendations.

Meanwhile, new schemes to weaken EPA scientific integrity via budget cutting are brewing for the federal fiscal year that began October 1, 2006. Congressional testimony revealed that EPA’s budget has already been cut by 14% since 2004. In a June memo uncovered by PEER, Lyons Gray, the EPA’s Chief Financial Officer, proposed a series of additional budget cuts even as Congress is reviewing an administration proposal to reduce EPA spending by 4%. Gray’s plans call for closing of 10% of EPA’s network of laboratories and research centers in which much of the agency’s basic and applied science concerning pollution monitoring, toxicological effects and other public health issues is conducted. The plans give EPA regional offices latitude to let go of higher-ranking scientists, analysts and managers.

The plan would also reduce federal oversight of State and Tribal environmental programs. Heather Taylor, deputy legislative director of the National Resources Defense Council, told the San Jose Mercury News, “First we take away the money to do their jobs, now we take away the oversight.”

Brian R. Hill, PhD, is Staff Scientist at PAN working on technical engagement with regulatory agencies.