The Federal Regulators
Speakers from Washington, D.C., included Margaret Jones, a biotechnologist with the Agricultural Biotechnology, Animal & Plant Health Inspection Service (APHIS) of the USDA, and Leonard Cole, of the EPA Bio-Pesticides and Pollution Prevention Division. Both outlined their respective agencies’ responsibility for biotech regulation, under the “Coordinated Framework” established in 1986, which determined that biotech plant and animal products would be regulated like any other plants and animals, with no new statutory requirements. Jones walked the audience through the various types of regulatory authority the USDA has for GE crops, starting with “notification,” “which is really a misnomer, we are notified but we also review,” an “expedited review for genes we’ve seen hundreds of times before.” For new crops, the USDA issues permits for release, looking at the distance the crops will be planted from wild weedy relatives, how the transgene differs from its parent, how it will be confined, and attempting to ensure that it doesn’t “persist in the environment.” For mandating segregation from other crops, Jones stated that the USDA follows the requirement for seed protection, a 660-foot buffer zone for corn, and doubles that distance for pharmaceutical crops. At that level, Jones claimed “there is no detectable gene flow.” [Curiously, the Maine Department of Agriculture has declined to require Monsanto to specify a buffer distance in its instructions to Maine farmers under the 2001 Act to Protect Against Contamination of Crops and Wild Plant Populations by Genetically Engineered Crops, contending that it is not required to until the USDA has also mandated a buffer distance, and that the USDA has no such requirement.] When the USDA reaches the conclusion that a GE crop presents “no significant impact on the environment,” it will, after public notice and comment, grant it “nonregulated status.” Many crops in non-regulated status have entered traditional breeding programs to have the new traits crossed via conventional means into other genetic varieties. Of the 81 applications to date for non-regulated status, 56 have been approved, 22 have been withdrawn, and three are pending. In response to an audience question about evidence that the Bt toxin is present in much larger quantities in GE plants than the quantities sprayed by organic farmers, and persists for up to a year in soils, Jones responded that there is “no reason to believe that the natural toxin is any different from the transgenic,” that she was “not sure what you mean by extremely large quantities,” and that “it does break down [in the soil].” Jones concluded with the comment that a decision has been made “not to treat this technology any different from any other technology used in conventional breeding.”
Leonard Cole outlined the EPA’s regulatory perspective on “PIPs” or “Plant Incorporated Protectants,” which genetically incorporate EPA-registered pesticides such as Bacillus thuringiensis (Bt) into plants, hence bringing them under EPA jurisdiction under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Cole’s outdated PowerPoint slide called them “Plant Incorporated Pesticides,” but the term “pesticides,” Cole cautiously noted, “is no longer used.” The remainder of his presentation was similarly designed to put the most innocuous face on this technology. While acknowledging that the EPA had been “under fire from grower and environmental groups,” Cole commented that “I hate to use the word safe, but these are less risky than any other products out there.” Cole repeatedly emphasized the “transparency” of EPA’s regulatory process, saying we “have the best website out there” [www.epa.gov/pesticides/biopesticides], and we make “all non-cbi [confidential business information] data publicly available.” Cole noted that last year the EPA exempted the foreign nucleic acids found in foods produced by PIPs, such as Bt sweet corn, from the requirement of setting a tolerance that applies to other pesticides. Hence, there is no government oversight of the quantity of these foreign nucleic acids that are present in foods. [This decision was based, according to the rule announcement, on the finding that nucleic acids “have always been present in human and domestic animal food and are not known to cause any adverse health effects.” (66 Fed. Reg. 130, July 19, 2001)].
Cole acknowledged that various risks are associated with the technology, including “toxicity, allergenic proteins, superweeds from pollen spread, insect resistance, antibiotic resistance, and effects on endangered species,” but argued that all of these were well controlled by the current regulatory system. Europe, he argued, has been “using biotechnology since 1800 in wines and cheeses, but they won’t tell us about it.” The latest generation of biotech crops under development, stacking multiple pesticidal proteins in one plant, Cole noted, “makes a better product.” Roundup Ready Corn was a regulated pesticide, Cole incorrectly stated, but it was regulated in a different department from his. “The ongoing StarLink corn redemption continues,” Cole acknowledged, and “how it got into the food system nobody knows.” (Later in response to an audience question, Cole speculated that contamination of the food system by StarLink may have been due to an “unscrupulous farmer,” and that “we have much better procedures now; we don’t intend that to happen again.” As he spoke, newswires were alive with reports of 500,000 bushels of soybeans in Nebraska that were ordered to be destroyed after they were found to be contaminated with residues of pharmaceutical corn planted in the same field the year before.)
EPA “100% Behind Biotechnology”
Cole concluded by arguing that wider adoption of biotechnology would benefit human health by reducing the use of chemical pesticides: “We have some sound scientists out there, doing all they can to reduce the burden of pesticides that are causing cancer in children, and breast cancer.” “Our Assistant Administrator,” Cole observed [Stephen Johnson, Assistant Administrator for Prevention, Pesticides and Toxic Substances], is “100% behind biotechnology.” Some in the audience expressed dismay at this attitude toward a regulated industry by the principal federal regulator in charge of environmental protection.
When queried whether the EPA had approved the use of the pesticides that were causing cancer in children, and why, then, the public should trust them in vouching for the safety of GE crops, Cole responded that under the Food Quality Protection Act of 1996, new protections exist for children’s food supply.
When asked about the adequacy of the funding for EPA to enforce provisions designed to protect the environment and food supply, Cole urged the audience to call their Congressional representatives to ask for more money for his agency: “Currently, we don’t have a large number of FTEs [full time equivalents] to get a lot of the work done.”
Asked whether it was true that the locations of field trials of crops incorporating pharmaceuticals was kept secret from the public, and whether any such crops were in Maine, Cole replied that he didn’t know, that “I haven’t seen any coming across my desk,” and that the locations of trials were kept secret “simply because groups will destroy them.”
Cole and Jones were asked whether they were involved in the assessment by the Interior Department of the adequacy of federal biotech oversight in the closing year of the Clinton Administration. Then Interior Science Advisor William Brown reported in The Environment Forum (Sept/Oct 2001) that the Interior Department staff found current regulation seriously inadequate to address environmental risk, particularly the risk of GE crops and animals becoming invasive species, and recommended a complete legislative overhaul of biotech regulation. Neither Cole nor Jones stated that they were personally involved, but they responded that their agencies continued to work to address the concerns of Interior, and that a proposal for legislation is “in the works.”
Dr. Michael Vayda, University of Maine professor of Biochemistry, Microbiology and Molecular Biology, gave the audience a basic lesson in DNA and the technology of genetic engineering. He described the technology as a way to “mix and match” DNA, by introducing a small number of traits in a specific gene, resulting in one or several new proteins. Implicitly refuting Cole’s contention that the Europeans have been doing this since the 1800s, Vayda described recombinant DNA technology as originating with the discovery 20 years ago of an enzyme that could be used to precisely cut DNA strands to insert new genes. Vayda described the technology as “very controlled work, very precise and selective as opposed to [traditional methods] of selective breeding.” “Does that mean I think there’s no risk? No. Each product needs to be seen on a case by case basis. Some may prove beneficial, others may be harebrained.” When queried about unanticipated and undetectable results from recombinant DNA techniques, Vayda acknowledged that engineered genes had been found on occasion to spontaneously turn off their expression, and that in “very rare” instances in the course of the exchange of maternal and paternal chromosomal material, an unanticipated division could occur in the middle of a gene, creating a new protein. “We know a tremendous amount,” Vayda argued, but “we just don’t know everything.” Vayda maintained that the potential benefits had to be weighed against the potential risks. When a member of the audience queried, “Whose benefits, and whose risks?” Vayda responded: “Yours. The consumer will decide. It’s your values as a public. If the people are morally outraged, it won’t be implemented.”
Vayda’s comments prompted many audience questions about the refusal of the federal government to require labeling of genetically engineered food. How can the consumer exercise her right to choose or not to choose the technology, without a label? Vayda conceded that there was a “consumer’s right to know,” and stated that he was not opposed to labeling, but argued that a simple “GMO free” label was not informative enough to be useful to a consumer. In response to Vayda’s comments, EPA’s Cole volunteered that all PIPs are required to be labeled as pesticides under FIFRA, but that when they become foods they are regulated by the FDA [which then does not require labels, and even recently has taken legal action against “GMO-free” labels, contending they illegally suggest the “free” products are better].
The Economics of Biotech
The afternoon program focused on two quite different perspectives on the economic impact of crop biotechnology. Featured speakers were Leonard Gianessi of the National Center for Food and Agricultural Policy, and Charles Benbrook of Benbrook Consulting Services, former Executive Director of the Board of Agriculture of the National Academy of Sciences. Benbrook has done a number of recent analyses of USDA data, determining that many of the claimed economic benefits of GE crops are not born out by the data [www.biotech-info.net]. He and Gianessi often have appeared against each other in debates about the benefits of the technology, although, as Benbrook quipped, “I’m invited less and less. Most public institutions taking on this issue want less often to hear from someone who questions biotechnology. There are potential benefits to biotechnology, but the way it’s been introduced and promoted falls far short of what any of us should accept.”
Gianessi led with a well-polished PowerPoint show vaunting the economic advantages to farmers of GE crops. While most of his data was based on cropping conditions in other parts of the country, he had made some effort to tailor his presentation to Maine farmers. Gianessi first addressed Roundup Ready corn, the only GE crop with significant plantings now in Maine [the other GE crop, the NewLeaf Bt potato, accounted for up to 5% of Maine potatoes, but was discontinued by Monsanto in 2001 because of lack of consumer acceptance]. Gianessi estimated that 2000 acres of Maine field corn last summer was Roundup Ready, about 6% of the Maine crop, as opposed to 8% adoption of Roundup Ready field corn nationwide. The Roundup Ready package of seed with a technology fee and Roundup herbicide costs about $28 an acre, and Gianessi conceded that the crop would not make economic sense for the average Maine farmer, whose weed control costs for field corn were $15 an acre. However, there are some acres with hard-to-control, triazine-resistant weeds, where costs in Maine could reach $38 an acre, for which the Roundup Ready system would yield a cost savings of $10/acre.
Gianessi then turned to Bt sweet corn, which is not yet licensed by the BPC for use in Maine. Gianessi noted that 2,500 acres of sweet corn are grown in Maine, yielding 11 million pounds of product a year, and that in states to the south, “Massachusetts, Pennsylvania, Maryland, and New York,” “farmers have embraced Bt corn as a great way to control pests.” However, with Bt sweet corn, Gianessi offered no cost comparisons to demonstrate savings to the farmer, nor data on the extent of acceptance in other New England states. A member of the audience asked whether it “wasn’t true that the cost advantage of Bt corn decreases as one moves north and east in the U.S., and whether that was why he provided no cost comparisons for Bt versus conventional corn.” Gianessi replied, “It’s true Bt sweet corn is priced for the Florida market and is not as good a fit here.” Florida growers make up to 12 pesticide applications a season [purportedly reduced by growing Bt corn], versus the typical three applications in Maine.
Again without making any cost and benefit analysis, Gianessi contended that Maine farmers should consider adopting Bt field corn, because it would reduce the worm infestation in corn fed to dairy cows. Worm infestation can lead to contamination of silage corn with a fungal mycotoxin called vomitoxin, which can cause gastrointestinal distress in cows, resulting in less milk production.
Gianessi spent considerable time discussing the potential economic benefits of GE crops not yet approved for commercial production. The average per acre costs for strawberries in Maine, including herbicides, cultivation, and hand weeding, is $459/acre. Gianessi estimated that Roundup Ready strawberries, under development, would cost $157/acre, including the $100 technology fee. When the audience questioned whether any farmer would choose this if consumers didn’t want to eat GE strawberries, Gianessi replied that “some consumers may prefer GE strawberries … knowing there’s less need for people doing menial labor, less tillage, less pesticides.” Benbrook retorted that, “I don’t think many Maine farmers are going to lobby the BPC for the right to pay Monsanto $100/acre technology fee to grow GE strawberries, but I could be wrong.”
A member of the audience asked Gianessi why his data were so much more optimistic than the May 2002 USDA report, released in August, which concluded that most of the basic economic claims of GE crops were “false or suspect.” [“The Adoption of Bioengineered Crops,” www.ers.usda.gov/publications/aer810. The report notes at p. 24, “Perhaps the biggest issue raised by these results is how to explain the rapid adoption of GE crops when farmer financial impacts appear to be mixed or even negative.”] Gianessi didn’t question that characterization of the USDA report, but said that the USDA database was four years old, and there were “a lot of frustrated researchers at the USDA.” Gianessi apparently drew much of his data directly from farmers rather than from USDA figures, recognizing the need for “flexibility” in trying to explain why farmers were adopting this technology: “We had to break new ground to explain why soybean growers were adopting this.”
When asked about the potential economic impact of the development of weeds that were resistant to Roundup, Gianessi contended that “no confirmation of any resistance in weeds” exists. The claims of glyphosate resistant marestail were, Gianessi claimed, “Not true.” This prompted the response by Benbrook that the biotech industry’s herbicide resistance action committee had established a “demanding academic standard for what constitutes resistance,” and that under that standard there were indeed “several reports of Roundup resistant marestail.” [see www.biotech-info.net/maverick_marestail.html}.
“If biotech crops were as safe, effective, and profitable as [Gianessi] has said, we would not be here.”
Charles Benbrook began his presentation by commenting that his longtime colleague Leonard Gianessi “is a master at presenting biotech’s rosy scenario,” but in some instances [his optimism] can’t be credibly supported by the facts. As an example of the problems in the hyperbolic promotion of GE technology, Benbrook related his recent trip to Zambia to respond to concerns about GE field corn given as food aide to the Zambian population. When Monsanto registered its package for Bt field corn, its “cursory regulatory review quickly dismissed any concerns about human health, because field corn is not eaten in the U.S.” Though the EPA did not carry out any assessment of the dietary risk of Bt field corn, “a starving people were given Bt corn to comprise 70 to 80% of their diet, plus a type they had not eaten a lot of.” “The credibility of the U.S. government was put on the line to say we knew this was safe. We have no scientific basis to make that statement.
“We may be the most technologically advanced country and the last remaining super power, but when it comes to this technology,” Benbrook argued, “we can’t see the forest for the trees.” Rather than addressing in detail his alternative economic analysis of the profitability of GE crops [available at www.biotech-info.net], Benbrook chose to address the larger economic perspective on the choice to adopt or not to adopt these crops, and its relationship to alternative approaches to agriculture. “I urge Maine to make up its own mind about what [biotech] will bring to Maine as net benefits – don’t adopt it because someone in Washington or the Biotech Council says you’re not a modern farmer if you don’t plant GMOs.” Maine, Benbrook advised, is “one of the few states where there is an option to make the decision [not to plant GMOs] … where the presence and role of GMOs is so modest that it would not take much if the consensus was to take a different route.”
Even under the best of circumstances, Benbrook argued, “there is no huge economic benefit from any known GE technology.” The advantages of using Roundup Ready corn in Maine, “even adopting [Gianessi’s] rosy scenario, are extremely modest.” The one GE food technology that would arguably be very profitable for Maine would, Benbrook acknowledged, be GE salmon [which are in development but not yet licensed for commercial production, and which grow six times faster than conventional aquaculture stock]. They could have “multimillion dollar consequences,” which “might be positive and might be negative.” Given the concerns about environmental risks of escaped fish, however, Benbrook said he would be “flabbergasted” if the fish were approved.
With GE crops, Benbrook cautioned that the one-size-fits-all GE technology may not be suited for Maine. “GM technologies weren’t developed to address Maine problems. They didn’t research the problems of Maine corn or potato producers.”
“You have to make a choice. It will be very difficult to have it both ways.”
Benbrook urged Maine to weigh the claimed benefits of GE crops carefully against the very real potential impact on organic agriculture. The organic dairy, meat, and poultry sectors are, Benbrook noted, one of the “major growth areas of agriculture” and are likely to take off even more, as “conventional meat and dairy production is in crisis, in a free fall, and the [food safety] problems are so systemic that it will take a decade or two before it gets any better.” Organic corn is the number one feed for organic dairy and livestock, and corn farmers get a 15% to 25% premium for organic feeds. A growth in organic dairy and livestock could create a new processing infrastructure in Maine, with new jobs. All of this is threatened, Benbrook argued, by the potential of contamination of organic corn crops by GE corn: “It’s probably inevitable that GMO growth will be at the expense of the organic sector, and vice versa. You have to make a choice. It will be very difficult to have it both ways.”
Benbrook challenged the BPC to commission a study, by University of Maine economists, comparing Gianessi’s projections for the economic benefit of GE crops in Maine, to the growth potential for organic meat and dairy production in Maine. Maine is “one of the few states in the country positioned well to take advantage of what everyone acknowledges is a major growth sector for American agriculture.”
In a question from the audience, Benbrook was asked to comment on the claims that biotechnology was a reliable and predictable technology. Benbrook replied that he “reads the technological scientific debate as close to unanimous that there’s more risk to gene instability in GMO crops than conventional crops.” He invited Vayda to comment and Vayda replied that “I don’t know of a single credible case where there’s been any health risk posed by a GMO.”
A member of the audience thanked Benbrook for his presentation, but stated that she was disturbed at how otherwise lopsided the forum was, representing a predominantly pro-biotech perspective. Benbrook replied that he was “used to being in this position.” The other panelists hastened to defend their neutrality. “As regulators we see ourselves as neutral,” Jones replied, “We listen to everybody. We’re here to get information.” Vayda responded that “the University of Maine is impartial on this issue … We have people who represent both ends of the spectrum.” Gianessi stated that his National Center for Food and Agricultural Policy was an “independent non-profit.” The NCFAP’s website, www.ncfap.org, reports that it receives funding from the USDA, the EPA, U.S. AID, the Rockefeller Foundation, commodity groups, agri-business, and agricultural chemical companies.
– Sharon Tisher