Re: The World According to Monsanto: Pollution, Corruption,
Posted: Sat Feb 06, 2016 2:28 am
Part 1 of 2
8: Scientists Suppressed
“When we finished the policy [relating to GMOs], all the scientists agreed with the policy,” James Maryanski told me with sudden assurance.
“You mean there was a consensus on the principle of substantial equivalence?”
“All of the different views were taken into account in the agency’s final decision about how it would proceed.”
No Consensus at the FDA
Maryanski was out of luck. The day before our meeting. I had visited the Web site of the Alliance for Bio-Integrity, an NGO based in Fairfield, Iowa.1 Headed by a lawyer named Steven Druker, it had sued the FDA for violation of the Food, Drug, and Cosmetic Act.2 With scientists, clergy members, and consumers as plaintiffs, the complaint was filed in federal court in Washington in May 1998, together with the Center for Food Safety, an NGO established in 1997.3 As one might have expected, the case was dismissed in October 2000, because the judge determined that the plaintiffs had not proved that the FDA regulation constituted a deliberate violation of federal law.4
Despite this legal setback, the complaint led to the declassification of some forty thousand pages of internal FDA documents related to GMOs. The least one can say is that this treasure trove of notes, letters, and memoranda presents a not-very-pretty picture of the way the agency handled this delicate issue, in light of its duty to protect the health of American consumers. In a document dated January 1993, FDA representatives acknowledged in plain language that, in accordance with government policy, their aim was to “promote” the biotechnology industry in the United States.5 But the highlights of this mass of information are the reports written by agency scientists, intended to express their opinions on the draft regulations submitted to them. The Alliance for Bio-Integrity had the excellent idea of putting these documents online.6 Some of them, of course, were addressed to the Biotechnology Coordinator.
For example, on November 1, 1991, Maryanski received a memorandum from the Division of Food Chemistry and Technology. The document pointed to all the “undesirable effects” that might be produced by the technique of genetic manipulation, such as an “increased levels of known naturally occurring toxicants, appearance of new, not previously identified toxicants, increased capability of concentrating toxic substances from the environment (e.g., pesticides or heavy metals), and undesirable alterations in the levels of nutrients.”7
And on January 31, 1992, Samuel Shibko of the Toxicology Section of the FDA, wrote: “We cannot assume that all gene products, particularly those encoded by genes from non-food sources, will be digestible. For example, there is evidence that certain types of proteins . . . are resistant to digestion and can be absorbed in biologically active form.”8
A few days later, it was the turn of Dr. Gerald Guest, director of the Center for Veterinary Medicine, to sound the alarm: “In response to your question on how the agency should regulate genetically modified food plants, I and other scientists at CVM have concluded that there is ample scientific justification to support a pre-market review of these products. . . . The FDA will be confronted with new plant constituents that could be of a toxicological or environmental concern.”9
Dr. Louis Pribyl of the FDA’s microbiology division dismissed out of hand the argument commonly put forth by promoters of biotechnology: “There is a profound difference between the types of unexpected effects from traditional breeding and genetic engineering, which is just glanced over in this document. . . . Multiple copies inserted at one site could become potential sites for rearrangements, especially if used in future gene transfer experiments, and as such may be more hazardous.”10
I could continue with examples showing that many divisions of the FDA, whatever their specialty, expressed strong concerns about the unknown health effects that might result from the process of genetic manipulation. In contradiction to what Maryanski now claims, there was no consensus on the FDA’s proposed regulation of GMOs even a few months before it was issued. Indeed, the former coordinator himself acknowledged this fact in a letter he sent on October 23, 1991, to Dr. Bill Murray, chairman of the Food Directorate, Canada: “There are a number of specific issues . . . for which a scientific consensus does not exist currently [in the FDA], especially the need for specific toxicology tests. . . . I think the question of the potential for some substances to cause allergenic reactions is particularly difficult to predict.”11
During my meeting with Maryanski, I read to him a memorandum he had been sent on January 8, 1992, by Dr. Linda Kahl, a compliance officer with responsibility for summarizing her colleagues’ views on the proposed regulation: “The document is trying to force an ultimate conclusion that there is no difference between foods modified by genetic engineering and foods modified by traditional breeding practices. This is because of the mandate to regulate the product not the process.” She went on to note that this mandate resembled a “doctrine”: “The processes of genetic engineering and traditional breeding are different, and according to the technical experts in the agency, they lead to different risks” (emphasis added).12
“What did you answer to Linda Kahl?” I asked Maryanski, who had lost his composure as soon as I began to read the document.
“My job was really to bring together the scientists who would be—provide the expertise to deal with, you know, to identify the issues and understand how to address them. I’m not the decision maker. The decision maker’s ultimately the commissioner, Dr. David Kessler.”
“Yes, but Dr. Kahl asked you a very specific question: ‘Are we asking the scientific experts to generate the basis for this policy statement in the absence of any data?’ (emphasis added). What was your answer?”
“Well, this is part of the early discussions that were going on.”
“Are you sure? Linda Kahl wrote this memorandum to you in January 1992—three months before the FDA published its policy. How could it get scientific data in this very short time?”
“Right, but the policy was designed to provide the guidance to the industry for the kinds of testing they would need to do.”
The Myth of Regulation
We had gotten to the point. Indeed, as Maryanski acknowledged, the document published by the FDA in 1992 was in no way a regulation, since its purpose was primarily to provide justifications for not regulating GMOs. It was only a statement of policy intended to provide direction to the industry and provide guidance in case of need. This was clearly indicated in the final section of the document, which provided for a mechanism for “voluntary consultation,” if companies so desired: “Producers should consult informally with FDA on scientific issues or design of appropriate test protocols when the function of the protein raises concern or is not known, or the protein is reported to be toxic. FDA will determine on a case-by-case basis whether it will review the food additive status of these proteins.”13
This outraged Joseph Mendelson, legal director of the Center for Food Safety. “In fact,” he told me, “the health of American consumers is at the mercy of the goodwill of the biotech companies that are licensed to decide, with no government supervision, whether their GMO products are safe. This is absolutely unprecedented in the history of the United States. The policy was drafted so the biotechnology industry could propagate the myth that GMOs are regulated, which is completely false. In the process, the country has been turned into a huge laboratory where potentially dangerous products have been set loose for the last ten years without the consumer being able to choose, because, in the name of the principle of substantial equivalence, labeling of GMOs is banned, and there is no follow-up.”
In March 2000, relying on various surveys indicating that more than 80 percent of Americans favored the labeling of transgenic foods14 and 60 percent would avoid them if they had the choice,15 the Center for Food Safety filed a citizen petition with the FDA asking it to review its policy on GMOs and that testing be required before they were sold and labeled.16 When the agency failed to respond, the Center for Food Safety filed suit in federal court in the spring of 2006. “We won’t give up,” Mendelson told me, “especially because quite obviously the mechanism for voluntary consultation the FDA had set up wasn’t working.”
He showed me a study by Dr. Douglas Gurian-Sherman, a former FDA scientist who had worked on assessing transgenic plants before joining the Center for Science in the Public Interest.17 He had gotten access to fourteen “voluntary consultation” files submitted to the FDA by biotechnology companies between 1994 and 2001 (out of a total of fifty-three), five of which concerned Monsanto. He found that in six cases, the FDA had asked the producer to provide more data so the agency could completely assess the safety of the products. “In three [50 percent] of those cases FDA’s requests were either ignored by the developer or the developer affirmatively declined to provide the requested information.” Two of these three cases concerned Monsanto’s transgenic corn, notably MON 810, to which I will return. Monsanto had never provided the further information the FDA had requested to be able to determine whether GM corn was in fact substantially equivalent to its conventional counterpart. The agency could do nothing, because, as Dr. Gurian-Sherman noted, the policy document—unlike an actual regulation— gave it “no authority to require the developers to submit the desired additional data unless it decided to evaluate the crop as a food additive.”
This was a decision the FDA made only once, on the Flavr Savr tomato at Calgene’s request. A declassified document shows that that decision had little effect and that, despite the results of toxicological tests, the agency approved the product. On June 16, 1993, Dr. Fred Hines sent a memorandum to Linda Kahl concerning the three toxicological tests conducted on rats fed with transgenic tomatoes for twenty-eight days. “In the second study, gross lesions were described in the stomachs of four out of twenty female rats fed one of the two lines of transgenic tomato. . . . The Sponsor’s . . . report concluded that . . . these lesions were incidental in nature. . . . The criteria for qualifying a lesion as incidental were not provided in the sponsor’s report.”18 But one year later, the FDA gave its approval to the tomato with the long shelf life.
Dr. Gurian-Sherman also examined the data summaries companies provided to the FDA for their “voluntary consultation” and found that in three cases out of fourteen, they contained “obvious errors” that had not been detected by agency scientists during their review. This point is very important, because it underscores the imperfection (to put it mildly) of the process for approving food or chemical products as it is conducted around the world. Very seldom do companies provide the raw data of the tests they have conducted; they generally merely prepare a summary that reviewers sometimes only skim. As Dr. Gurian-Sherman very persuasively puts it: “The more highly summarized and less detailed those data, the greater the role of the developer in determining the safety of the crop, and conversely the more the FDA must rely on the developer’s judgment.”
He also analyzed the quality of the tests conducted by the producers, and his conclusions are troubling. He found that some fundamental health considerations were frequently neglected, such as the toxicity or allergenicity of proteins in the transgenic plants.
Finally, he raised a concluding technical point that is of primary importance because it undermines the validity of practically all the toxicological tests conducted on GMOs, particularly by Monsanto. Generally, to measure the toxicity and allergic potential of the proteins produced in the plant by the inserted gene, the companies did not use the proteins as they were expressed in the manipulated plant, but those present in the original bacterium, that is, before the gene derived from the bacterium was transferred. Officially, they proceeded in this way because it was difficult to remove a sufficient quantity of the pure transgenic protein from the plant but much easier to do so from the bacterium, which could produce as much protein as was needed.
In the view of some scientists, this practice might well represent a manipulation intended to conceal a fact that companies such as Monsanto had always made a point of denying: the inserted genes, and hence the proteins they produced, were not always identical to the original genes and proteins. Indeed, random insertion caused the appearance of unknown proteins. Dr. Gurian-Sherman concluded: “Therefore, bacterially produced protein may not be identical to, and have the same health effects as, the GE protein from the plant.”
The Unshakable Team of Maryanski and Taylor
Even as FDA scientists were expressing their disagreement with the policy document, it was published on May 29, 1992. Two months earlier, on March 20, Commissioner David Kessler wrote a very curious memorandum to the secretary of health and human services, urgently requesting authorization to publish the document in the Federal Register. “The new technologies give producers powerful, precise tools to introduce improved traits in food crops, opening the door to improvements in foods that will benefit food growers, processors, and consumers. Companies are now ready to commercialize some of these improvements. To do so, however, they need to know how their products will be regulated. This is critical not only to provide them with a predictable guide to government oversight but also to help them with public acceptance of these new products. . . . Furthermore, the Biotechnology Working Group of the Council on Competitiveness wants us to issue a policy statement as soon as possible. . . . The approach and provisions of the policy statement . . . respond to the White House interest in assuring the safe, speedy development of the U.S. biotechnology industry.”
The commissioner’s memorandum concluded with the mention of “potential controversy,” fostered by “environmental defense groups,” including Jeremy Rifkin’s: “They may challenge our policy as leaving too much decision making in the hands of industry and not adequately informing consumers.” Attached to the memorandum was a copy of the policy statement with two very interesting notations: “Drafted: J. Maryanski. Cleared: M. Taylor.”
“This document is proof that the FDA policy statement was not written to protect the health of Americans, but to satisfy strictly industrial and commercial aims,” asserts Steven Druker of the Alliance for Bio-Integrity. “To reach its goal, the American government has continually lied to its own citizens and to the rest of the world, claiming that the principle of substantial equivalence was supported by a broad consensus in the scientific community and that a good deal of scientific data substantiated it: these two assertions are blatant lies. Decided on at the highest levels, with the active complicity of Monsanto, this huge enterprise of disinformation was carried out by an unshakable team: James Maryanski and Michael Taylor.”
“What exactly was Maryanski’s role?” I asked, a little shaken by the vehemence of his language.
“His role was to propagate the transgenic gospel inside and outside the agency. I met him several times, and he never deviated from the party line, even when he testified before Congress.”
In fact, the complaint filed by the Alliance for Bio-Integrity had created a stir, and Maryanski was called to testify before the Senate Committee on Agriculture, Nutrition, and Forestry on October 7, 1999. After explaining at length the grounds for the FDA policy statement, he concluded his statement with this: “FDA takes seriously its mandate to protect consumers in the United States and to ensure that the United States’ food supply continues to be one of the safest in the world. . . . We are confident that our approach is appropriate. It allows us to ensure the safety of new food products and . . . it gives manufacturers the ability to produce better products and provide consumers additional choices.”
“Maryanski’s other role was to smooth over differences inside the FDA, if necessary by stifling dissident voices with the support of Michael Taylor,” Druker went on, showing me another declassified document that his organization had put online. This was a letter dated October 7, 1991, from the biotechnology coordinator to the deputy commissioner for policy, which contained the following: “Suggest that you consider discussing your goals for developing our food biotechnology policy by the end of the year with Dr. Guest, CVM. Most crops developed by the new biotechnology that will be used for human foods will also be used as feed for animals. . . . I think CVM would appreciate hearing your thoughts.”19 Maryanski was obviously putting Taylor forward to stifle the rebellion that was brewing in the Center for Veterinary Medicine. The document also shows that Michael Taylor, the former Monsanto lawyer, was the person who determined the purposes of the regulation that was then being drafted.
“Michael Taylor was Monsanto’s man at the FDA, which hired him specifically to supervise the regulation of GMOs and created the position for that purpose,” said Druker. “The declassified documents reveal that he worked to empty the policy statement of any scientific substance, which caused a good deal of discontent on the staff.”
During my lengthy recorded telephone conversation with the former Monsanto vice president, he persistently denied any direct involvement in the preparation of the policy statement: “That’s false. I wasn’t the author of the policy. I was the deputy commissioner for policy who oversaw the process. But the policy was developed by the FDA’s professional career people based on the law and the science.”
When I reported these words to Michael Hansen, he literally jumped out of his chair and pulled out a document published in 1990 by the International Food Biotechnology Council (IFBC). This ephemeral body was set up in 1988 by the International Life Sciences Institute (ILSI), well known to all anti-GMO activists. Established in 1978 by major food industry corporations—the Heinz Foundation, Coca-Cola, Pepsi-Cola, General Foods, Kraft (owned by Philip Morris), and Procter and Gamble—ILSI calls itself a “non-governmental organization” and describes itself on its Web site as “a global network of scientists devoted to enhancing the scientific basis for public health decision-making.”20 As the British daily The Guardian revealed in 2003, the organization was well connected in the World Health Organization and the Food and Agriculture Organization, two UN bodies it lobbied in favor of GMOs through a document published in 1990 by the IFBC.21 And it was precisely this document, a statement of principles on the way GMOs should be regulated, entitled “Biotechnologies and Food: Assuring the Safety of Foods Produced by Genetic Modification,” that Hansen had just pulled out.22
“Remember that Michael Taylor came to the FDA in July 1991,” Hansen went on. “Until then he’d been working at the law firm of King and Spalding. His clients included not only Monsanto but also the IFBC, the International Food Biotechnology Council. He wrote this document setting out the way the organization would like GMOs to be regulated. If you compare this proposal Taylor wrote for the IFBC and the policy statement published by the FDA, you can see they are very similar. If he didn’t write the statement, then someone took his proposal and changed it slightly before publishing it.” The anonymous IFBC document, oddly unavailable on the Web, is in fact the first reference cited in the appendix to the FDA policy statement.23
“Again, it’s false,” Taylor insisted. “I could not possibly have anything to do with it because I’m not a scientist. So, again, this is why you need to be talking to Dr. Maryanski and people who were actually involved in developing the FDA policy.” When I subsequently interviewed Maryanski, he found it hard to get rid of this new hot potato. “Mr. Taylor was the deputy commissioner at the time, and he provided leadership for the project and served as the chief, sort of the leader . . . policy person, in terms of making sure the project got done.”
“Did you know that he used to work for Monsanto as an attorney?”
“I think I knew that he had, you know, been at Monsanto, but, you know, we often have people come in and they’re appointed as commissioner or deputy commissioner.”
“What was the role of Monsanto in the FDA?”
“Well, Monsanto was very active, in fact very helpful to FDA in terms of helping us to understand just what does it mean to use genetic engineering in food crops. I remember meetings that we had where the Monsanto scientists met with the FDA scientists and they went through the kinds of modifications that they were making and how those were being done. And basically, what they were also saying to FDA was, ‘How will these products be regulated?’ ”
The Champion of the Revolving Door
“You think it was a plot?” The question I asked Jeffrey Smith when I met him in Fairfield, Iowa in October 2006 made him pause for reflection. He is the executive director of the Institute for Responsible Technology and the author of two very well-informed books on GMOs that I have already referred to.24 The silence is something I have encountered from most of those I have interviewed who have dared to denounce Monsanto’s practices, because the company is so ready to threaten costly litigation. Smith knew this very well: he had been forced to self-publish his books because he could not find a publisher willing to stand up to Monsanto. Monsanto says that it is only trying to protect its patents, but the company has been willing to spend millions of dollars and even lose at trial, as if its real purpose were to bleed its opponents dry. This is why every word had to be weighed before it was launched into the public arena.
“The word ‘plot’ is a little strong,” he finally answered. “But from the company’s point of view, let’s say it took power without a single misstep, thanks to its savoir-faire and its ability to infiltrate all the decision-making machinery in the country.” Among the elements behind its success were financial contributions to the election campaigns of the two major parties. According to figures from the Federal Election Commission, in 1994, Monsanto contributed $268,732, almost equally divided between Democrats (then holding the White House) and Republicans. In 1998, the amount was $198,955, almost two-thirds for the Republicans. Two years later, George W. Bush’s party received $953,660 compared to $221,060 for Al Gore’s Democrats. Finally, in 2002, as the White House was launching its crusade against “international terrorism,” the Republican party collected $1,211,908 compared to $322,028 for the Democrats. At the same time, lobbying expenses for the leading producer of GMOs were officially $21 million between 1998 and 2001, with a record of $7.8 million in 2000, the year of Bush’s election. [i]
Probably more decisive than these political expenses—rather modest in American terms—was the ability to infiltrate, illustrated by a system already glimpsed in the case of bovine growth hormone: the revolving door, at which, according to Smith, “Monsanto is the national champion.” “Take the Bush administration,” he said, showing me a list covering several pages. “Four important departments are headed by people close to Monsanto, either because they’ve received contributions from the company or because they have worked directly for it. Attorney General John Ashcroft was backed by Monsanto when he ran for reelection in Missouri, and the company supported Tommy Thompson, the secretary of health and human services [which oversees the FDA], when he ran for governor in Wisconsin. Ann Venneman, the secretary of agriculture, was on the board of directors of Calgene, owned by Monsanto. Secretary of Defense Donald Rumsfeld was the CEO of Searle, a Monsanto subsidiary. And let’s not forget Clarence Thomas, who was a lawyer for Monsanto before working for Senator Danforth of Missouri and later being appointed to the Supreme Court.”
On Smith’s list, which can in part be found on the Web, one discovers that the revolving door moves people in at least four directions.25 First, consider movements from the White House to Monsanto. For example, Marcia Hale, former assistant to President Bill Clinton for intergovernmental affairs, was appointed director of international government affairs for Monsanto in 1997. Her colleague Josh King, former director of production for White House events, has continued his career as director of global communications in Monsanto’s Washington office. Mickey Kantor, U.S. trade representative from 1992 to 1997 and commerce secretary from 1996 to 1997, immediately thereafter joined the company’s board of directors, and so on.
The second direction is that taken by former members of Congress and their staffs, who have become registered lobbyists for the company, such as former Democratic congressman Toby Moffett, who became a political strategist for Monsanto, and Ellen Boyle and John Orlando, former congressional staffers later hired as lobbyists.
The revolving door also moves people from the regulatory agencies to Monsanto. We have already seen that Linda Fisher was appointed Monsanto vice president for governmental affairs in 1995 after serving as assistant administrator of the EPA, and William Ruckelshaus, who headed the agency from May 1983 to January 1985, later joined the company’s board of directors. Similarly, Michael Friedman, former deputy director of the FDA, was hired by Monsanto’s pharmaceutical subsidiary Searle.
But the flow of people is even stronger in the other direction, from Monsanto to governmental or intergovernmental agencies. Recall that in 1989 Margaret Miller moved from the company’s labs to the FDA. Her colleague Lidia Watrud joined the EPA. Virginia Meldon, former Monsanto public relations director, was hired by the Clinton administration. More recently, Rufus Yerxa, former chief counsel for Monsanto, was appointed U.S. representative to the World Trade Organization (WTO) in August 2002, and in January 2005, Martha Scott Poindexter was hired by the Senate Committee on Agriculture, Nutrition, and Forestry after serving as director of governmental affairs for Monsanto’s Washington office. Finally, Robert Fraley, one of the “discoverers” of Roundup Ready soybeans, who became a Monsanto vice president, was named a technical adviser to USDA.
8: Scientists Suppressed
“The Composition of Glyphosate-Tolerant Soybean Seeds Is Equivalent to That of Conventional Soybeans.”
—Title of a study published by Monsanto in the Journal of Nutrition, April 1996
“When we finished the policy [relating to GMOs], all the scientists agreed with the policy,” James Maryanski told me with sudden assurance.
“You mean there was a consensus on the principle of substantial equivalence?”
“All of the different views were taken into account in the agency’s final decision about how it would proceed.”
No Consensus at the FDA
Maryanski was out of luck. The day before our meeting. I had visited the Web site of the Alliance for Bio-Integrity, an NGO based in Fairfield, Iowa.1 Headed by a lawyer named Steven Druker, it had sued the FDA for violation of the Food, Drug, and Cosmetic Act.2 With scientists, clergy members, and consumers as plaintiffs, the complaint was filed in federal court in Washington in May 1998, together with the Center for Food Safety, an NGO established in 1997.3 As one might have expected, the case was dismissed in October 2000, because the judge determined that the plaintiffs had not proved that the FDA regulation constituted a deliberate violation of federal law.4
Despite this legal setback, the complaint led to the declassification of some forty thousand pages of internal FDA documents related to GMOs. The least one can say is that this treasure trove of notes, letters, and memoranda presents a not-very-pretty picture of the way the agency handled this delicate issue, in light of its duty to protect the health of American consumers. In a document dated January 1993, FDA representatives acknowledged in plain language that, in accordance with government policy, their aim was to “promote” the biotechnology industry in the United States.5 But the highlights of this mass of information are the reports written by agency scientists, intended to express their opinions on the draft regulations submitted to them. The Alliance for Bio-Integrity had the excellent idea of putting these documents online.6 Some of them, of course, were addressed to the Biotechnology Coordinator.
For example, on November 1, 1991, Maryanski received a memorandum from the Division of Food Chemistry and Technology. The document pointed to all the “undesirable effects” that might be produced by the technique of genetic manipulation, such as an “increased levels of known naturally occurring toxicants, appearance of new, not previously identified toxicants, increased capability of concentrating toxic substances from the environment (e.g., pesticides or heavy metals), and undesirable alterations in the levels of nutrients.”7
And on January 31, 1992, Samuel Shibko of the Toxicology Section of the FDA, wrote: “We cannot assume that all gene products, particularly those encoded by genes from non-food sources, will be digestible. For example, there is evidence that certain types of proteins . . . are resistant to digestion and can be absorbed in biologically active form.”8
A few days later, it was the turn of Dr. Gerald Guest, director of the Center for Veterinary Medicine, to sound the alarm: “In response to your question on how the agency should regulate genetically modified food plants, I and other scientists at CVM have concluded that there is ample scientific justification to support a pre-market review of these products. . . . The FDA will be confronted with new plant constituents that could be of a toxicological or environmental concern.”9
Dr. Louis Pribyl of the FDA’s microbiology division dismissed out of hand the argument commonly put forth by promoters of biotechnology: “There is a profound difference between the types of unexpected effects from traditional breeding and genetic engineering, which is just glanced over in this document. . . . Multiple copies inserted at one site could become potential sites for rearrangements, especially if used in future gene transfer experiments, and as such may be more hazardous.”10
I could continue with examples showing that many divisions of the FDA, whatever their specialty, expressed strong concerns about the unknown health effects that might result from the process of genetic manipulation. In contradiction to what Maryanski now claims, there was no consensus on the FDA’s proposed regulation of GMOs even a few months before it was issued. Indeed, the former coordinator himself acknowledged this fact in a letter he sent on October 23, 1991, to Dr. Bill Murray, chairman of the Food Directorate, Canada: “There are a number of specific issues . . . for which a scientific consensus does not exist currently [in the FDA], especially the need for specific toxicology tests. . . . I think the question of the potential for some substances to cause allergenic reactions is particularly difficult to predict.”11
During my meeting with Maryanski, I read to him a memorandum he had been sent on January 8, 1992, by Dr. Linda Kahl, a compliance officer with responsibility for summarizing her colleagues’ views on the proposed regulation: “The document is trying to force an ultimate conclusion that there is no difference between foods modified by genetic engineering and foods modified by traditional breeding practices. This is because of the mandate to regulate the product not the process.” She went on to note that this mandate resembled a “doctrine”: “The processes of genetic engineering and traditional breeding are different, and according to the technical experts in the agency, they lead to different risks” (emphasis added).12
“What did you answer to Linda Kahl?” I asked Maryanski, who had lost his composure as soon as I began to read the document.
“My job was really to bring together the scientists who would be—provide the expertise to deal with, you know, to identify the issues and understand how to address them. I’m not the decision maker. The decision maker’s ultimately the commissioner, Dr. David Kessler.”
“Yes, but Dr. Kahl asked you a very specific question: ‘Are we asking the scientific experts to generate the basis for this policy statement in the absence of any data?’ (emphasis added). What was your answer?”
“Well, this is part of the early discussions that were going on.”
“Are you sure? Linda Kahl wrote this memorandum to you in January 1992—three months before the FDA published its policy. How could it get scientific data in this very short time?”
“Right, but the policy was designed to provide the guidance to the industry for the kinds of testing they would need to do.”
The Myth of Regulation
We had gotten to the point. Indeed, as Maryanski acknowledged, the document published by the FDA in 1992 was in no way a regulation, since its purpose was primarily to provide justifications for not regulating GMOs. It was only a statement of policy intended to provide direction to the industry and provide guidance in case of need. This was clearly indicated in the final section of the document, which provided for a mechanism for “voluntary consultation,” if companies so desired: “Producers should consult informally with FDA on scientific issues or design of appropriate test protocols when the function of the protein raises concern or is not known, or the protein is reported to be toxic. FDA will determine on a case-by-case basis whether it will review the food additive status of these proteins.”13
This outraged Joseph Mendelson, legal director of the Center for Food Safety. “In fact,” he told me, “the health of American consumers is at the mercy of the goodwill of the biotech companies that are licensed to decide, with no government supervision, whether their GMO products are safe. This is absolutely unprecedented in the history of the United States. The policy was drafted so the biotechnology industry could propagate the myth that GMOs are regulated, which is completely false. In the process, the country has been turned into a huge laboratory where potentially dangerous products have been set loose for the last ten years without the consumer being able to choose, because, in the name of the principle of substantial equivalence, labeling of GMOs is banned, and there is no follow-up.”
In March 2000, relying on various surveys indicating that more than 80 percent of Americans favored the labeling of transgenic foods14 and 60 percent would avoid them if they had the choice,15 the Center for Food Safety filed a citizen petition with the FDA asking it to review its policy on GMOs and that testing be required before they were sold and labeled.16 When the agency failed to respond, the Center for Food Safety filed suit in federal court in the spring of 2006. “We won’t give up,” Mendelson told me, “especially because quite obviously the mechanism for voluntary consultation the FDA had set up wasn’t working.”
He showed me a study by Dr. Douglas Gurian-Sherman, a former FDA scientist who had worked on assessing transgenic plants before joining the Center for Science in the Public Interest.17 He had gotten access to fourteen “voluntary consultation” files submitted to the FDA by biotechnology companies between 1994 and 2001 (out of a total of fifty-three), five of which concerned Monsanto. He found that in six cases, the FDA had asked the producer to provide more data so the agency could completely assess the safety of the products. “In three [50 percent] of those cases FDA’s requests were either ignored by the developer or the developer affirmatively declined to provide the requested information.” Two of these three cases concerned Monsanto’s transgenic corn, notably MON 810, to which I will return. Monsanto had never provided the further information the FDA had requested to be able to determine whether GM corn was in fact substantially equivalent to its conventional counterpart. The agency could do nothing, because, as Dr. Gurian-Sherman noted, the policy document—unlike an actual regulation— gave it “no authority to require the developers to submit the desired additional data unless it decided to evaluate the crop as a food additive.”
This was a decision the FDA made only once, on the Flavr Savr tomato at Calgene’s request. A declassified document shows that that decision had little effect and that, despite the results of toxicological tests, the agency approved the product. On June 16, 1993, Dr. Fred Hines sent a memorandum to Linda Kahl concerning the three toxicological tests conducted on rats fed with transgenic tomatoes for twenty-eight days. “In the second study, gross lesions were described in the stomachs of four out of twenty female rats fed one of the two lines of transgenic tomato. . . . The Sponsor’s . . . report concluded that . . . these lesions were incidental in nature. . . . The criteria for qualifying a lesion as incidental were not provided in the sponsor’s report.”18 But one year later, the FDA gave its approval to the tomato with the long shelf life.
Dr. Gurian-Sherman also examined the data summaries companies provided to the FDA for their “voluntary consultation” and found that in three cases out of fourteen, they contained “obvious errors” that had not been detected by agency scientists during their review. This point is very important, because it underscores the imperfection (to put it mildly) of the process for approving food or chemical products as it is conducted around the world. Very seldom do companies provide the raw data of the tests they have conducted; they generally merely prepare a summary that reviewers sometimes only skim. As Dr. Gurian-Sherman very persuasively puts it: “The more highly summarized and less detailed those data, the greater the role of the developer in determining the safety of the crop, and conversely the more the FDA must rely on the developer’s judgment.”
He also analyzed the quality of the tests conducted by the producers, and his conclusions are troubling. He found that some fundamental health considerations were frequently neglected, such as the toxicity or allergenicity of proteins in the transgenic plants.
Finally, he raised a concluding technical point that is of primary importance because it undermines the validity of practically all the toxicological tests conducted on GMOs, particularly by Monsanto. Generally, to measure the toxicity and allergic potential of the proteins produced in the plant by the inserted gene, the companies did not use the proteins as they were expressed in the manipulated plant, but those present in the original bacterium, that is, before the gene derived from the bacterium was transferred. Officially, they proceeded in this way because it was difficult to remove a sufficient quantity of the pure transgenic protein from the plant but much easier to do so from the bacterium, which could produce as much protein as was needed.
In the view of some scientists, this practice might well represent a manipulation intended to conceal a fact that companies such as Monsanto had always made a point of denying: the inserted genes, and hence the proteins they produced, were not always identical to the original genes and proteins. Indeed, random insertion caused the appearance of unknown proteins. Dr. Gurian-Sherman concluded: “Therefore, bacterially produced protein may not be identical to, and have the same health effects as, the GE protein from the plant.”
The Unshakable Team of Maryanski and Taylor
Even as FDA scientists were expressing their disagreement with the policy document, it was published on May 29, 1992. Two months earlier, on March 20, Commissioner David Kessler wrote a very curious memorandum to the secretary of health and human services, urgently requesting authorization to publish the document in the Federal Register. “The new technologies give producers powerful, precise tools to introduce improved traits in food crops, opening the door to improvements in foods that will benefit food growers, processors, and consumers. Companies are now ready to commercialize some of these improvements. To do so, however, they need to know how their products will be regulated. This is critical not only to provide them with a predictable guide to government oversight but also to help them with public acceptance of these new products. . . . Furthermore, the Biotechnology Working Group of the Council on Competitiveness wants us to issue a policy statement as soon as possible. . . . The approach and provisions of the policy statement . . . respond to the White House interest in assuring the safe, speedy development of the U.S. biotechnology industry.”
The commissioner’s memorandum concluded with the mention of “potential controversy,” fostered by “environmental defense groups,” including Jeremy Rifkin’s: “They may challenge our policy as leaving too much decision making in the hands of industry and not adequately informing consumers.” Attached to the memorandum was a copy of the policy statement with two very interesting notations: “Drafted: J. Maryanski. Cleared: M. Taylor.”
“This document is proof that the FDA policy statement was not written to protect the health of Americans, but to satisfy strictly industrial and commercial aims,” asserts Steven Druker of the Alliance for Bio-Integrity. “To reach its goal, the American government has continually lied to its own citizens and to the rest of the world, claiming that the principle of substantial equivalence was supported by a broad consensus in the scientific community and that a good deal of scientific data substantiated it: these two assertions are blatant lies. Decided on at the highest levels, with the active complicity of Monsanto, this huge enterprise of disinformation was carried out by an unshakable team: James Maryanski and Michael Taylor.”
“What exactly was Maryanski’s role?” I asked, a little shaken by the vehemence of his language.
“His role was to propagate the transgenic gospel inside and outside the agency. I met him several times, and he never deviated from the party line, even when he testified before Congress.”
In fact, the complaint filed by the Alliance for Bio-Integrity had created a stir, and Maryanski was called to testify before the Senate Committee on Agriculture, Nutrition, and Forestry on October 7, 1999. After explaining at length the grounds for the FDA policy statement, he concluded his statement with this: “FDA takes seriously its mandate to protect consumers in the United States and to ensure that the United States’ food supply continues to be one of the safest in the world. . . . We are confident that our approach is appropriate. It allows us to ensure the safety of new food products and . . . it gives manufacturers the ability to produce better products and provide consumers additional choices.”
“Maryanski’s other role was to smooth over differences inside the FDA, if necessary by stifling dissident voices with the support of Michael Taylor,” Druker went on, showing me another declassified document that his organization had put online. This was a letter dated October 7, 1991, from the biotechnology coordinator to the deputy commissioner for policy, which contained the following: “Suggest that you consider discussing your goals for developing our food biotechnology policy by the end of the year with Dr. Guest, CVM. Most crops developed by the new biotechnology that will be used for human foods will also be used as feed for animals. . . . I think CVM would appreciate hearing your thoughts.”19 Maryanski was obviously putting Taylor forward to stifle the rebellion that was brewing in the Center for Veterinary Medicine. The document also shows that Michael Taylor, the former Monsanto lawyer, was the person who determined the purposes of the regulation that was then being drafted.
“Michael Taylor was Monsanto’s man at the FDA, which hired him specifically to supervise the regulation of GMOs and created the position for that purpose,” said Druker. “The declassified documents reveal that he worked to empty the policy statement of any scientific substance, which caused a good deal of discontent on the staff.”
During my lengthy recorded telephone conversation with the former Monsanto vice president, he persistently denied any direct involvement in the preparation of the policy statement: “That’s false. I wasn’t the author of the policy. I was the deputy commissioner for policy who oversaw the process. But the policy was developed by the FDA’s professional career people based on the law and the science.”
When I reported these words to Michael Hansen, he literally jumped out of his chair and pulled out a document published in 1990 by the International Food Biotechnology Council (IFBC). This ephemeral body was set up in 1988 by the International Life Sciences Institute (ILSI), well known to all anti-GMO activists. Established in 1978 by major food industry corporations—the Heinz Foundation, Coca-Cola, Pepsi-Cola, General Foods, Kraft (owned by Philip Morris), and Procter and Gamble—ILSI calls itself a “non-governmental organization” and describes itself on its Web site as “a global network of scientists devoted to enhancing the scientific basis for public health decision-making.”20 As the British daily The Guardian revealed in 2003, the organization was well connected in the World Health Organization and the Food and Agriculture Organization, two UN bodies it lobbied in favor of GMOs through a document published in 1990 by the IFBC.21 And it was precisely this document, a statement of principles on the way GMOs should be regulated, entitled “Biotechnologies and Food: Assuring the Safety of Foods Produced by Genetic Modification,” that Hansen had just pulled out.22
“Remember that Michael Taylor came to the FDA in July 1991,” Hansen went on. “Until then he’d been working at the law firm of King and Spalding. His clients included not only Monsanto but also the IFBC, the International Food Biotechnology Council. He wrote this document setting out the way the organization would like GMOs to be regulated. If you compare this proposal Taylor wrote for the IFBC and the policy statement published by the FDA, you can see they are very similar. If he didn’t write the statement, then someone took his proposal and changed it slightly before publishing it.” The anonymous IFBC document, oddly unavailable on the Web, is in fact the first reference cited in the appendix to the FDA policy statement.23
“Again, it’s false,” Taylor insisted. “I could not possibly have anything to do with it because I’m not a scientist. So, again, this is why you need to be talking to Dr. Maryanski and people who were actually involved in developing the FDA policy.” When I subsequently interviewed Maryanski, he found it hard to get rid of this new hot potato. “Mr. Taylor was the deputy commissioner at the time, and he provided leadership for the project and served as the chief, sort of the leader . . . policy person, in terms of making sure the project got done.”
“Did you know that he used to work for Monsanto as an attorney?”
“I think I knew that he had, you know, been at Monsanto, but, you know, we often have people come in and they’re appointed as commissioner or deputy commissioner.”
“What was the role of Monsanto in the FDA?”
“Well, Monsanto was very active, in fact very helpful to FDA in terms of helping us to understand just what does it mean to use genetic engineering in food crops. I remember meetings that we had where the Monsanto scientists met with the FDA scientists and they went through the kinds of modifications that they were making and how those were being done. And basically, what they were also saying to FDA was, ‘How will these products be regulated?’ ”
The Champion of the Revolving Door
“You think it was a plot?” The question I asked Jeffrey Smith when I met him in Fairfield, Iowa in October 2006 made him pause for reflection. He is the executive director of the Institute for Responsible Technology and the author of two very well-informed books on GMOs that I have already referred to.24 The silence is something I have encountered from most of those I have interviewed who have dared to denounce Monsanto’s practices, because the company is so ready to threaten costly litigation. Smith knew this very well: he had been forced to self-publish his books because he could not find a publisher willing to stand up to Monsanto. Monsanto says that it is only trying to protect its patents, but the company has been willing to spend millions of dollars and even lose at trial, as if its real purpose were to bleed its opponents dry. This is why every word had to be weighed before it was launched into the public arena.
“The word ‘plot’ is a little strong,” he finally answered. “But from the company’s point of view, let’s say it took power without a single misstep, thanks to its savoir-faire and its ability to infiltrate all the decision-making machinery in the country.” Among the elements behind its success were financial contributions to the election campaigns of the two major parties. According to figures from the Federal Election Commission, in 1994, Monsanto contributed $268,732, almost equally divided between Democrats (then holding the White House) and Republicans. In 1998, the amount was $198,955, almost two-thirds for the Republicans. Two years later, George W. Bush’s party received $953,660 compared to $221,060 for Al Gore’s Democrats. Finally, in 2002, as the White House was launching its crusade against “international terrorism,” the Republican party collected $1,211,908 compared to $322,028 for the Democrats. At the same time, lobbying expenses for the leading producer of GMOs were officially $21 million between 1998 and 2001, with a record of $7.8 million in 2000, the year of Bush’s election. [i]
Probably more decisive than these political expenses—rather modest in American terms—was the ability to infiltrate, illustrated by a system already glimpsed in the case of bovine growth hormone: the revolving door, at which, according to Smith, “Monsanto is the national champion.” “Take the Bush administration,” he said, showing me a list covering several pages. “Four important departments are headed by people close to Monsanto, either because they’ve received contributions from the company or because they have worked directly for it. Attorney General John Ashcroft was backed by Monsanto when he ran for reelection in Missouri, and the company supported Tommy Thompson, the secretary of health and human services [which oversees the FDA], when he ran for governor in Wisconsin. Ann Venneman, the secretary of agriculture, was on the board of directors of Calgene, owned by Monsanto. Secretary of Defense Donald Rumsfeld was the CEO of Searle, a Monsanto subsidiary. And let’s not forget Clarence Thomas, who was a lawyer for Monsanto before working for Senator Danforth of Missouri and later being appointed to the Supreme Court.”
On Smith’s list, which can in part be found on the Web, one discovers that the revolving door moves people in at least four directions.25 First, consider movements from the White House to Monsanto. For example, Marcia Hale, former assistant to President Bill Clinton for intergovernmental affairs, was appointed director of international government affairs for Monsanto in 1997. Her colleague Josh King, former director of production for White House events, has continued his career as director of global communications in Monsanto’s Washington office. Mickey Kantor, U.S. trade representative from 1992 to 1997 and commerce secretary from 1996 to 1997, immediately thereafter joined the company’s board of directors, and so on.
The second direction is that taken by former members of Congress and their staffs, who have become registered lobbyists for the company, such as former Democratic congressman Toby Moffett, who became a political strategist for Monsanto, and Ellen Boyle and John Orlando, former congressional staffers later hired as lobbyists.
The revolving door also moves people from the regulatory agencies to Monsanto. We have already seen that Linda Fisher was appointed Monsanto vice president for governmental affairs in 1995 after serving as assistant administrator of the EPA, and William Ruckelshaus, who headed the agency from May 1983 to January 1985, later joined the company’s board of directors. Similarly, Michael Friedman, former deputy director of the FDA, was hired by Monsanto’s pharmaceutical subsidiary Searle.
But the flow of people is even stronger in the other direction, from Monsanto to governmental or intergovernmental agencies. Recall that in 1989 Margaret Miller moved from the company’s labs to the FDA. Her colleague Lidia Watrud joined the EPA. Virginia Meldon, former Monsanto public relations director, was hired by the Clinton administration. More recently, Rufus Yerxa, former chief counsel for Monsanto, was appointed U.S. representative to the World Trade Organization (WTO) in August 2002, and in January 2005, Martha Scott Poindexter was hired by the Senate Committee on Agriculture, Nutrition, and Forestry after serving as director of governmental affairs for Monsanto’s Washington office. Finally, Robert Fraley, one of the “discoverers” of Roundup Ready soybeans, who became a Monsanto vice president, was named a technical adviser to USDA.