The Monsanto Files

The Ecologist September October 1998 (This edition was trashed by the printing office after threats from Monsanto) {footnotes are missing}

Revolving Doors: Monsanto and the Regulators

by Jennifer Ferrara

Traditionally, key figures at the FDA in particular have either held important positions at Monsanto, or are destined to do so in the future. Is it surprising therefore that Monsanto gets clearance frr its often dangerous products?

Though the evolution of genetic engineering from a laboratory science to a method of creating commercial products happened very fast - within a decade - the US government saw the commercialization of biotechnology coming and deliberately chose a path that has amounted to nonregulation. Genetic engineering broke through natural barriers of reproduction and sped up plant and animal breeding processes, but agribusiness corporations were wary that burdensome regulations would hinder new discoveries and therefore the commercial development of the technology. The federal government took up industry's cause. Instead of establishing strict, precautionary regulations that gave priority to public and environmental health, the government patched together an inadequate regulatory system that relied on risk assessment, industry science, and corporate volunteerism.

The US was in the heat of a high-tech economic race with Japan, and, as far as agriculture was concerned, lawmakers saw genetic engineering as the new technology that would allow the US to maintain its position as the world's agricultural "leader".The federal government would erect no law that might reduce America's competitiveness in the future world market for bioengineered products.

The first government body to establish guidelines for biotechnology research was the National Institutes of Health (NIH) in 1976.[1] Since the NIH is an advisory and not a regulatory body, it could formulate guidelines, but it had no power to enforce them. From the beginning, the NIH guidelines relied on the scientific community's and industry's self-regulation, starting a trend that continues today. As corporations became more involved in genetic engineering, NIH guidelines made accommodations for field tests and mass production of genetically engineered organisms. In 1977 and 1978, 16 bills to regulate genetic research were introduced in the US Congress. None was passed, and the NIH guidelines - which dealt primarily with medical and pharmaceutical research and did not take a precautionary approach - remained the sole regulatory mechanism for biotechnology research.

In the early 1980s, agribusiness corporations were developing genetically engineered plants, animal drugs, and livestock, but no system was in place to regulate the development, sale, or use of these products.[2] This was the era of the deregulatory Reagan/Bush administration, which developed the framework by which bioengineered products, including food, are "regulated" today. Industrial profit, not public safety, was the administration's top priority. Government officials in the Office of Management and Budget, the Departments of State and Commerce, and the White House Office of Science and Technology Policy wanted to ensure that the administration did not do anything to "stifle" the dev[3] The Bush-era President's Council on Competitiveness, chaired by Vice-President Dan Quayle, joined the biotechnology industry in opposing strong regulations and close oversight by federal agencies.[4]

The result was a 1986 "biotechnology regulatory framework".[5] The policy was founded on the corporate-generated assertion that bioengineering was just an extension of traditional plant and animal breeding, and that bioengineered products did not differ fundamentally from non-engineered organisms.[6] The administration determined that existing federal agencies could regulate bioengineered products sufficiently and gave them overlapping regulatory authority.[7] For instance, the Food and Drug Administration (FDA) would regulate bio-engineered organisms in food and drugs. The United States Department of Agriculture would regulate genetically engineered crop plants and animals. The Environmental Protection Agency would regulate genetically engineered organisms released into the environment for pest control. And the NIH would look at organisms that could affect public health. In determining that existing agencies could do the job of regulating bioengineered products, the administration avoided passing new, more stringent federal laws or establishing a new regulatory agency devoted to the task.


As late as 1994, it appeared that the federal government was still playing catch-up in establishing working biotechnology safety regulations. The Union of Concerned Scientists (UCS), which monitors the biotechnology industry and the federal regulatory system, was pointing out big holes in the so-called framework." "Fundamentally, it does not contain sufficient statutory authority to oversee all of the products and activities entailed in genetic engineering," wrote UCS in February 1994. "Where authority does exist, there are problems with implementing regulations and policies." For example, a 1992 FDA policy exempted corporations from having to test bioengineered food for safety and get FDA approval before the foods are put on the market.'2 Unless the corporation determined that "sufficient safety questions exist",'3 corporations could undergo voluntary, private "consultations" with the agency before marketing their product.'4


The Regulatory Irony




FDA Scandals and Revolving Doors

To better understand how genetically engineered foods and the associated safety hazards were unleashed onto the American public, take a look at the story of the first mass-marketed bioengineered food product, the Monsanto corporation's recombinant bovine growth hormone (rBGH). rBGH has been linked to cancer in humans and serious health problems in cows, including udder infections and reproductive problems. rBGH's development and approval was rife with scandal and protest. But the right combination of government backing, corporate science, and heavily-funded corporate public relations schemes paved the way for the first major release of a genetically engineered food into the nation's food supply.

The roles played by the FDA and the Monsanto corporation in the development, safety evaluation, approval, and marketing of rBGH led to the exposure of the American public to the multiple hazards of bioengineered foods. These organizations hid important information about safety concens, masked disturbing conflicts of interest, and stifled those who were asking the "wrong" questions and telling the truth about rBGH.

The FDA declared rBGH-milk safe for human consumption before important information about how rBGH-milk might affect human health was even available.'6 When critical information about how rBGH raised the levels of insulin-like growth factor, IGF-1, in milk'7 and the possible link between IGF-1 and human cancer began to emerge,'8 [See Kingsnorth in this issue] the FDA was already apparently in too deep to change its mind or ask more questions about the drug's effect on human health. Instead, the agency relied almost exclusively on data generated by the Monsanto corporation and highly criticized by independent scientists to justify a decision it had made years Many independent scientists have called for more extensive, long-term studies, which have never been done.

In 1991, a researcher at the University of Vermont (UVM). where Monsanto was spending nearly half a million dollars to fund test trials of rBGH, leaked information about severe health problems affecting rBGH-treated cows, including mastitis and deformed births)1 The scientist heading the research had already made numerous public statements to state lawmakers and the press and released a preliminary report indicating that rBGH-treated cows suffered no abnormal rates of health problems compared with untreated cows.'2 The US General Accounting Office (GAO) investigated. During the investigation, the FDA stalled in providing the GAO with original Monsanto test data.23 and the GAO was unable to obtain critical data from UVM and Monsanto24 The GAO terminated its investigation, concerned that Monsanto had had time to manipulate the questionable data and that any further investigation would be Fruitless. In an effort to dissipate public concern, UVM scientists finally released information showing rBGH's negative effect on cow health, years after the findings had been made."












Published with permission of The Ecologist. The original article is published online at The Ecologist.

"Genetically Engineered Food - Safety Problems"
Published by PSRAST

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