Complete and Accurate Data

When the FDA first introduced its policy on GM foods, they created a method by which the biotech companies could voluntarily consult with the agency. All companies chose to participate, as it was quite superficial. The New York Times described it as a way the companies could "talk to regulators about the safety of their new genetically engineered products at least 120 days before they are sold."39

In response to public criticism about the regulatory policy on GM foods and demands by consumer and environmental groups for mandatory labeling of GM foods, in May 1999 the Clinton administration announced a set of changes that were meant to bolster consumer confidence. Chief among these was to make these same consultations mandatory.

Ohio congressman Dennis Kucinich described the meaningless changes as a way to deflect legitimate concerns about the technology. "This proposal is full of genetically engineered baloney," said Kucinich, who described the proposed mandatory consultations as "not worth the paper they are written on."40

Even "FDA officials acknowledged the new rule will mean few, if any, changes for biofood developers," reported Reuters. "The companies have considerable freedom to decide what research information and data to share with the agency. The FDA's mandatory consultations will not affect that."41

On January 18,2001, more than a year and a half after Clinton had asked the agency to make consultations mandatory, the agency responded with their proposal. But the agency's version required mandatory "notification," not consultation. In other words, companies did not have to talk with the FDA at all. They could just send in a letter, known as a pre-market biotechnology notice, which describes the food, its method of development, whether it used antibiotic resistant marker genes, information about substances introduced into the foods (including allergenicity issues), and some information comparing it to a conventional food.

After another two and a half years of not implementing even this watered down proposal, on June 17,2003, FDA Deputy Commissioner Lester Crawford told the House Agriculture Committee's subcommittee on research that the agency had decided to abandon the requirement altogether. According to Greg Jaffe, biotechnology director for the Center for Science in the Public Interest, "Under the current system, they [biotech companies] could market something without us even knowing it." Jaffe said, "That is not the best way to ensure the safety or instill consumer confidence in these crops."42

By putting companies in charge of determining if their products are safe, apparendy the government trusts the private sector to conduct the proper tests and to accurately report any safety issues. A look at the record, however, demonstrates plenty of evidence to the contrary.

In January 1992, months before the FDA policy of self-policing became official, the GAO "claimed that the FDA might be approving drugs for food-producing animals on the basis of'invalid, inaccurate or fraudulent data' supplied by private laboratories." The GAO said the FDA's "inadequate procedures" could mean that it "may be unable to fulfill its mission to protect the health and safety of animals and people."

This wasn't the first time the FDA had been accused of relying on filtered or flawed industry reports. In 1975, Ralph Moss reported that three pharmaceutical companies had "withheld pertinent information or simply fed the agency false data. . . . Even though either strong administrative sanctions or criminal prosecution might have ensued had FDA so wished, FDA Commissioner Alexander Schmidt told Senate investigators that 'the cases somehow went into some bottomless pit that we have not been able to identify.'"31

Also at that time, after studies revealed that the drugs Aldactone and Flagyl "were correlated with cancer in test animals. . . . Ralph Moss reported: 'Further investigation revealed that Searle had known about the tumor-producing potential of these items but had simply given the FDA fraudulent data.'" Searle was the tenth largest pharmaceutical company at the time. It later became a wholly owned subsidiary of Monsanto.

A report by the Washington Post revealed that in 1975, while investigating the safety of PCBs, Monsanto's "company study found that PCBs caused tumors in rats. They ordered its conclusion changed from 'slighdy tumorigenic' to 'does not appear to be carcinogenic.'"43

And in 1990, EPA scientist Cate Jenkins discovered several instances of apparent fraud by Monsanto and urged the agency to do a criminal investigation. She wrote, "Monsanto has in fact submitted false information to the EPA which directly resulted in weakened regulations." Jenkins cited internal Monsanto documents that reveal, among other things, that they doctored samples of herbicides that were submitted to the USDA, hid evidence, substituted false information "and excluded several hundred of its sickest former employees from its comparative health studies."44 Jenkins said the "study by Monsanto apparently has not been shown to be a fraud."45

Methods of Influence

How does the biotech industry do it? How do they continue to virtually dictate policy to the U.S. regulatory agencies in spite of such serious and blatant past transgressions?

Certainly considerable campaign contributions have an influence. The four leaders of the biotech industry—Monsanto, Dow, DuPont, and Novartis (now Syngenta)—gave more than $3.5 million in PAC, soft-money, and large individual contributions between 1995 and 2000—three-quarters of it to Republicans.46

In 1994, 181 congressmen co-sponsored a bill that would require labeling of GM foods. But the twelve-member Dairy Livestock and Poultry Committee stalled the bill until the end of the 1994 session— effectively killing it. In testimony before an FDA panel, Robert Cohen said, "I investigated these twelve men and found that collectively they took $711,000 in PAC money from companies with dairy interests, and four of the members of the committee took money directly from Monsanto."47

Monsanto's Shapiro was among the largest contributors of soft money to the Clinton re-election campaign in 1996.48 Shapiro, in turn, became a member of the President's Advisory Committee for Trade Policy and Negotiations and served a term as a member of the White House Domestic Policy Review.44 And Clinton even praised Monsanto by name in a State of the Union address.48

Lobbying is another way the biotech industry exerts influence. According to the Center for Responsive Politics, between 1998 and

2002, the industry spent $143 million on lobbying. This includes the Biotechnology Industry Organization (BIO), which lobbies and advertises on behalf of the whole industry. According to a June 2002 Associated Press report, BIO "has a total budget of $30 million, employs 70 and represents 1,000 companies." It has made a diverse list of enemies, including the National Right to Life Committee, which accuses BIO of "wielding undue influence on legislation."49

"They're everywhere," says Joe Mendelson, legal director of the Center for Food Safety. "The biotech industry is a political force. It's increasing in clout." The organization even runs pro-biotech TV commercials "in Washington, D.C., clearly aimed at legislators considering the issue."49 In addition, the industry has committed a quarter of a billion dollars over five years to convince the public that GM foods are the right choice.

Perhaps even more important than donations, lobbying, and advertising, is the role personal connections play in winning political support. According to the New Tork Times, Monsanto maintains "close ties to policy makers—particularly to trade negotiators." For example, Mickey Kantor, former secretary of the United States Department of Commerce, was a personal friend of Monsanto's CEO Shapiro. Naturally, when Kantor became the trade representative of the United States under Clinton, a strong, sometimes bullying pro-biotech strategy pervaded the U.S. trade stance with the rest of the world. "Confrontation in trade negotiations became the order of the day," reported the New Tork Times. "Senior administration officials publicly disparaged the concerns of European consumers as the products of conservative minds unfamiliar with the science."1

(This mindset continues. In March 2003, Speaker of the House Hastert lashed out at the European Union's "protectionist, discriminatory trade policies" on GMOs, which the Speaker called "non-tariff barriers that are based on fear and conjecture—not science."50)

After leaving government office, Mickey Kantor became a member of Monsanto's board of directors. Another official-turned-board-member was William Ruckelshaus, the former chief administrator of the EPA. The Globe and Mail describes Monsanto as "a virtual retirement home for members of the Clinton administration. "48

Another former EPA employee, Linda Fisher, became vice president of government and public affairs for Monsanto before returning to the EPA to become their second in command. Iidia Watrud, former biotechnology researcher at Monsanto, joined the EPA's Environmental Effects Laboratory.

At the FDA, two former Monsanto employees along with Michael Taylor, approved Monsanto's genetically engineered bovine growth hormone—which no other industrialized nation has yet deemed safe for their cows or their milk drinking population. Taylor, by the way, is a cousin of A1 Gore's wife Tipper Gore. "The Food and Drug Administration," says Betty Martini of the consumer group Mission Possible, "is so closely linked to the biotech industry now that it could be described as their Washington branch office."48

To navigate Washington's complex bureaucracy, Monsanto looks to their director of international government affairs, Marcia Hale. She had been assistant to the president of the United States and director for intergovernmental affairs. Similarly, Monsanto's director of global communication, Josh King, was formerly the director of production for White House events.51

Some other strategic job swaps between the biotech industry and government: Genentech's David W. Beier became Vice President A1 Gore's chief domestic policy advisor. Clayton K. Yeutter, former Secretary of Agriculture and former U.S. trade representative, became a member of Mycogen's board of directors. L. Val Giddings, Vice President of BIO, was biotechnology regulator and (biosafety) nego tiator at the USDA. And Terry Medley, DuPont's director of regulatory and external affairs, held senior positions at the USDA and FDA.

Leading figures in the George W. Bush administration also have significant ties to the biotech sector. Agriculture Secretary Ann Veneman was an attorney with a firm that represented biotech corporations. She was also on the board of Calgene, Inc., now a subsidiary of Monsanto.52 Defense Secretary Donald Rumsfeld was the president of another Monsanto subsidiary, Searie—makers of the genetically engineered sweetener aspartame. Mitch Daniels, director of the office of management and budget, was vice president at Eli Lilly Pharmaceutical company, partners with Monsanto on the genetically engineered bovine growth hormone. Tommy Thompson, secretary of health, received $50,000 from biotech firms during his earlier Wisconsin gubernatorial election. Thompson used state funds for a $317 million dollar biotech zone in the state.53 John Ashcroft, attorney general, was the largest recipient of campaign funds from Monsanto in the 2000 election, while Supreme Court Judge Clarence Thomas once worked as Monsanto's lawyer.

Journalist Bill Lambrecht described an example of how Washington's biotech connections came into play during a carefully orchestrated 1998 St. Patrick's Day reception for the Irish prime minister, Bertie Ahern. His vote was needed to carry the EU's acceptance of Monsanto's GM corn. When Ahern had lunch with National Security Advisor Council Director Sandy Berger, the topic that Berger chose to focus on was the need to get that corn vote. Again, when Ahern met Senator Bond from Missouri and several members of congress, the issue was GM corn. According to Toby Moffet a former congressman turned Monsanto man, "Everywhere he went, before people said 'Happy St. Patrick's Day,' they asked him, 'What about that corn vote?'" The amazed Moffet said, "I'm fifty-four years old, and I've been in a lot of coalitions in my life, but this is one of the most breathtaking I've seen."

The next day, Ireland cast its vote in favor of Monsanto's GM corn, the first time Ireland acted in favor of a GMO release. When revelations of the events in Washington were made public by Lambrecht in the St. Louis Post Dispatch, the Irish group Genetic Concern charged in a press release, "U.S. multinationals have more influence than the Irish electorate."54

Moderate Dissent among the Ranks

Former Secretary of Agriculture Dan Glickman had been one of the Clinton administration's staunchest defenders of biotech, touring Europe with industry representatives to promote GM foods. In an interview just before stepping down from office, he said:

"What I saw genetically on the pro-biotech side was the attitude that the technology was good, and that it was almost immoral to say that it wasn't good, because it was going to solve the problems of the human race and feed the hungry and clothe the naked. . . . And there was a lot of money that had been invested in this, and if you're against it, you're Luddites, you're stupid. That, frankly, was the side our government was on. Without thinking, we had basically taken this issue as a trade issue and they, whoever 'they' were, wanted to keep our product out of their market. And they were foolish, or stupid, and didn't have an effective regulatory system. There was rhetoric like that even here in this department. You felt like you were almost an alien, disloyal, by trying to present an open-minded view on some of the issues being raised. So I pretty much spouted the rhetoric that everybody else around here spouted; it was written into my speeches."55 In 1999, however, Glickman broke ranks with the pro-biotech hardliners of the Clinton administration, albeit cautiously. In a speech at Purdue University, he said the United States "can't force-feed consumers" around the world. And in a speech at the Press Club in Washington, "Glickman advised biotechnology companies to consider labeling genetically modified food to help prevent consumer fears from spreading to the United States."55

According to the St. Louis Post Dispatch, "That was not what the heavily invested industries—or the White House, for that matter—had expected him to say. He purposely had not submitted his speech for approval beforehand, he recalled, because he knew it would be returned to him 'sterile.' Afterward, he felt the heat." Glickman said, "There were some people in this government who were very upset with me. Very upset."

When Glickman met the president's wife, Hillary Rodham Clinton, at a White House dinner a few days after his speech, Glickman later reported: "She said, 'I saw the story about your speech in the New York Times.'' I said to her, 'There were some people in the White House that didn't like it.' She said, 'I liked it.' So I knew I wasn't going to be fired."

Glickman's concerns about GM foods run deeper than just labeling. He wants "a thorough review of how GMOs are regulated by our government." He says, "I think it does need further clarity."56

Where Has the Government's Push Gotten Them?

Dan Quayle's Council on Competitiveness de-regulated GM food in order to strengthen the economy and make American products more competitive overseas. In the decade since, here is what has happened.

Major retailers and food manufacturers around the world responded to consumer pressure by vowing to remove GM ingredients from their brands. In Europe, nearly the entire food manufacturing and retail industry has banned GM ingredients, and the majority of the world's population are covered by restrictions on the sale and use of GM crops.57

Because of the difficulty of segregating GM crops from non-GM crops, many overseas buyers have simply rejected all com, soy, canola, and cotton from the U.S. and Canada. Since these four GM crops and their derivatives are found in most processed foods in the U.S., American-made packaged foods are also off-limits in many markets.

U.S. corn exports to Europe have been virtually eliminated, down by 99.4 percent. Likewise, Canada's annual canola sales to Europe vanished as has their honey—tainted by GM pollen.58 U.S. soy, which enjoyed 57 percent of the world market, dropped by about a fifth to 46 percent.59 Soy is principally used for animal feed. U.S. soy sales have been supported by the fact that, until recently, few importers expressed concern about feeding animals GM feed. But overseas retailers are now promising to sell meat that was raised on non-GM sources. The USDA announced in May 2001 that European demand for non-GM feed jumped from near zero to 20 to 25 percent within twelve months.58

The lost markets for U.S. crops contributed to near record low prices. The American Corn Growers Association (ACGA) calculated the resultant drop in corn prices at 13 to 20 percent.57 According to Charles Benbrook, former executive director of the National Academy of Sciences' Board on Agriculture, growers have only been kept afloat by the huge jump in subsidies.60 Benbrook estimates government payments to farmers are up by $3 to 5 billion annually due to the economic damage of GM crops alone.57

GM tomatoes and potatoes failed to take hold and have been taken off the market. GM sugar beet, flax, and rice, while approved, were never commercialized. When Monsanto pushed hard to introduce GM wheat, more than 80 percent of U.S. and Canadian wheat buyers said they didn't want it and might shop elsewhere if it were introduced. More than 200 groups, including the U.S. and Canadian National Farmers Unions, the Canadian Wheat Board, and the American Corn Growers Association, lobbied against Monsanto, ultimately forcing them to announce on May 10, 2004, that they were canceling their plans to develop GM wheat for the near future.

Even in the U.S. where there has been far less news coverage of the GMO issue, more and more food manufacturers are committing to remove GM ingredients from their products. "First major health food retail chains such as Whole Foods and Wild Oats rejected GMOs. Now mainstream American retailer Trader Joe's has followed suit as a result of market research: 'The majority of our customers would prefer to have products made without genetically engineered ingredients.' Other, even larger U.S.-based food companies, including Frito-Lay, Gerber, Heinz, Seagram and Hain, have also decided not to use GMOs in their products."57 A 2003 ABC news poll also revealed that 92 percent the U.S. population want GM food to be labeled.

Stuck with products no one wants, the U.S. has tried to give GM grain away as food aid to developing nations. But consumer groups and governments alike regularly reject the food, which they say has not been proven safe.

So instead of creating a solution to the trade deficit, GM crops have been a disaster for U.S. trade. "In total, with the lower profitability of GM crops, the loss of foreign trade, the lower market prices, the costs of the StarLink corn recall and other incidents, the farm subsidy rise, and the lost . . . organic market opportunities, GM crops could have cost the U.S. economy some $12 billion net from 1999 to 2001."61

When Robert Shapiro shifted Monsanto's strategy to the fast track, he predicted rapid, global acceptance of GM crops. Although the top biotech companies own 23 percent of the commercial seed market and total GM acreage for exceeds the size of the UK, many observers agree that Monsanto's push of genetically engineered foods has been a failure. The company's aggressive strategy has been credited, in part, for the eruption of global opposition to GM foods.

Shapiro confessed to a Greenpeace gathering in October 1999 that Monsanto "irritated and antagonized people."62 Will Carpenter, who headed Monsanto's biotechnology strategy group until 1991, describes it more eloquendy. "When you put together arrogance and incompetence, you've got an unbeatable combination. You can get blown up in any direction. And they were."

The U.S. government, however, continues to echo the gung-ho attitude that Glickman describes. They blame anti-GMO sentiment largely on baseless, irrational fears. According to the book, Trust Us

We're Experts, "Government and industry insiders rationalize the gulf that separates them from popular opinion by dismissing citizen concerns with the usual rhetoric about the public's ignorance. Terms such as 'Luddite' and 'looney' abound as the biotechnicians compete among themselves to see who can express the most contempt for the intelligence of the great unwashed masses."63

U.S. Deputy Secretary of Commerce David Aaron told European representatives in 1999, "Not a rash, not a sneeze, not a cough, not a watery eye has been developed from [GM foods], and that's because we have been extremely carefid in our process of approving them."

He said that the FDA found no scientific proof that GM foods were harmful. He said the reason that Americans were not against GM food is because they trust the FDA. The problem, according to Aaron, was not with the foods. It was the fact that Europe had no American-style FDA. Aaron said, "We would like the governments ... to develop a transparent, systematic approval process that is based on science."64 That would be nice.

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