Almost three years ago, the StarLinkTM corn incident inflamed opposition against genetically modified (GM) crops. The GM corn, which produces a Bacillus thuringeniesis (Bt) insecticidal protein, had been accidentally mixed with conventional corn. In another case of inadvertent commingling, Monsanto Company (St. Louis, MO) announced last spring that conventional canola seeds may contain unapproved GT-200 canola seeds, which mature to Roundup®-resistant plants. This possibility seemed to stimulate little public interest, but the next case of GM crop contamination was different; this case was about biopharming.
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note: Considering that it is virtually impossible to segregate
crops from each other at any level of production, the proliferation of
biopharm crops is quite mad. Growing GMO corn in Mexico is illegal, but it
can be imported, and has been via food aid contributions by the US. That
corn was distributed throughout Mexico and has now been found to have
polluted the native varieties in the far regions of Oaxaca |
The potential benefits of biopharming are considerable. The use of transgenic plants to produce therapeutic proteins could provide a means to manufacture therapeutic compounds at lower cost and in greater amounts. On the other hand, many have been uneasy about the prospect of biopharm crops potentially mixing with conventional food crops. This apprehension was justified by the U.S. Department of Agriculture's November announcement that GM corn produced for ProdiGene, Inc. (College Station, TX) had been mixed with conventional soybeans. ProdiGene had reportedly engineered the corn to produce a protein used in a swine vaccine. The USDA slapped the company with a hefty fine, but some viewed this penalty as an insufficient deterrent to prevent future incidents.
By the end of the year, The Genetically Engineered Food Alert (Washington, D.C.), a coalition of seven organizations, filed a petition requesting that the USDA initiate an immediate moratorium on the planting of food crops engineered to produce pharmaceuticals or industrial chemicals. The coalition also requested the USDA to prepare environmental impact statements for all biopharm crops.
Another coalition requested a similar ban in early 2003. This time, the group represented food manufacturers and restaurants. The Grocery Manufacturers of America, Inc. (Washington, D.C.) took the position that the USDA should create a presumption against the use of food or feed crops for pharmaceutical production unless the company developing the drug clearly demonstrates that it is not feasible to use nonfood crops.
So far, the USDA has not initiated a ban on biopharming. But on March 6, the agency's Animal and Plant Health Inspection Service (APHIS) announced proposed rules for the regulation of field-testing of plants designed to produce pharmaceutical and industrial compounds. Under the new rules, the USDA will increase the frequency of GM crop site inspections, and the agency will prohibit farmers from growing conventional corn within one mile of a field test site for the duration of any field test that involves open-pollinated GM corn. APHIS will also require farmers to operate planters and harvesters dedicated to use in the permitted test sites for the duration of the tests and dedicated facilities for the storage of equipment and regulated articles.
The proposed regulations include a prohibition against the planting of a food crop the year after the land was used for biopharming. This ban might have been inspired by the ProdiGene incident. Following a standard crop rotation practice, farmers had planted conventional soybeans on land previously used to grow ProdiGene's GM corn. The result: corn seed left from the transgenic crop grew into the soybean fields.
During a pre-briefing on the proposed rules, Bobby Acord, the administrator for APHIS, said that the proposed changes are designed "to make absolutely certain that there are no ProdiGenes in the future." Acord assured reporters that APHIS has the resources to meet the challenge of increased inspections, even though APHIS transferred over 2600 of its agriculture quarantine inspectors to the Department of Homeland Security.
For a short time, the Biotechnology Industry Organization had proposed a ban on GM corn biopharming in the Corn Belt. To a certain extent, this geographic isolation approach is built into the proposed rules. Cindy Smith, APHIS's deputy administrator for Biotechnology Regulatory Services, told reporters that the agency anticipates fewer corn field trials in the Corn Belt, because it may be difficult to secure land with the required one-mile isolation distance in an area where land is best suited for corn. Furthermore, the proposed rules would take the most productive land out of use by prohibiting farmers from cultivating conventional food or feed crops on ground used for a GM crop test during the following growing season.
Food industry representatives and biotechnology opponents labeled the proposals inadequate. The rule that the food industry and certain environmental groups wanted was a provision that only nonfood crops could be used to produce pharmaceuticals. The USDA's position is that such a rule would not prevent contamination of nonfood GM plants with conventional crops. Rather, the agency chose to focus on methods intended to prevent any intermingling of GM plants and conventional plants.
A coalition of 11 U.S. environmental groups, farm organizations, and consumer groups threatened to sue the USDA unless the agency temporarily halts planting of GM crops that produce pharmaceuticals or industrial compounds. The coalition accused the USDA of allowing GM crops to be planted without conducting environmental risk assessments and alleged that the agency violated the National Environmental Policy Act. The groups notified the USDA of their intention to file a suit in federal court by May 5. A copy of the 60 day notice letter of intent to sue is available at the Center for Food Safety's website (http://www.centerforfoodsafety.org).
From Biopharming to More Conventional GM Crops On February 25, the Environmental Protection Agency announced its approval for the commercialization of Monsanto's YieldGard® Rootworm Corn (MON 863). This GM plant produces a Bacillus thuringiensis spp. kumamotoensis delta-toxin protein (Cry3Bb1), which kills Western corn rootworm—the pest responsible for the greatest use of insecticides in the United States and the number one blight of U.S. corn.
The Bt toxin kills 50 to 80 percent of the rootworm larvae that eat the roots of transgenic corn. Such a system creates selection pressure for larvae that are resistant to the toxin. To reduce the risk of developing a Bt toxin-resistant rootworm population, the EPA is requiring Monsanto to ensure that 20 percent of the planted acreage of YieldGard Rootworm Corn is set aside for growth of conventional corn. These refuge areas will support populations of corn rootworm not exposed to the Bt toxin. Insect populations in the refuges are expected to crossbreed with any insects resistant to Bt toxin, thereby limiting the numbers of Bt toxin-resistant rootworms. This resistance management strategy was developed as a condition of EPA registration.
Environmentalists were not pleased by the 20 percent refuge area requirement. The EPA's scientific panel apparently urged a requirement for farmers to plant refuge areas covering 50 percent of the GM crop acreage, but Monsanto pushed for the lower level. Stephen L. Johnson, the EPA's assistant administrator for prevention, pesticides, and toxic substances, brushed off criticism of the 20 percent level, stating that this requirement would be in effect for only three years while the potential for toxin resistance is studied further.
The commercialization of GM wheat is also encountering disapproval. A consortium of U.S. agricultural and environmental groups filed a Citizen Petition on March 11 with the USDA seeking a moratorium on the commercial introduction of herbicide-resistant GM wheat, such as Monsanto's Roundup Ready® wheat. The petition seeks an environmental impact statement on the deregulation of GM wheat varieties and requests the listing of GM wheat varieties as noxious weeds. A copy of the Citizen Petition is available from The Center for Food Safety website.
The effect of GM wheat on U.S. exports is a major concern. U.S. wheat exporters currently sell wheat to foreign markets with a USDA-approved statement that no GM wheat is commercialized in the United States. According to the petitioners, GM wheat will cross-pollinate with other wheat, making it impossible for U.S. farmers to export their crops to foreign markets with GM food bans, such as the European Union. Joseph Mendelson, The Center for Food Safety's legal director, promised that the legal petition is the first step to a lawsuit if the USDA did not address the petitioners' concerns.
A few days after the petition was filed, the USDA announced that it may impose strict requirements on Monsanto to ensure that the company abides by its pledges. Monsanto has stated that the company will not introduce Roundup Ready wheat to the marketplace until the demonstration of food, feed, and environmental safety, resulting in regulatory approvals in the United States, Canada, and Japan. The company has also promised to develop grain handling protocols and standardized sampling and detection methods to separate GM wheat from conventional wheat.
The ability to isolate GM crops from conventional crops is a major stumbling block in the progress of agbiotech. The petitioners argue that the events surrounding StarLink corn, ProdiGene corn, and GT-200 canola incidents show that "the current U.S. grain handling system is unlikely to be prepared to sufficiently segregate genetically engineered and non-genetically engineered wheat to the point at which foreign importers will have confidence in the integrity of such shipments."
Selected References
Franz N. (2003) Food groups seek moratorium on pharma crops. Chemical Week 165: 83, February 19.
Gillis J. (2003) In key test, U.S. allows sale of genetically engineered corn. The Washington Post, A.01, February 26.
Kilman S and Carroll J. (2002) Monsanto admits unapproved seed may be in crops. Wall Street Journal, A.3, April 15.
Pollack A. (2003) U.S. imposes stricter rules for genetically modified crops. The New York Times, A.23, March 7.
USDA. (2003) Field testing of plants engineered to produce pharmaceutical and industrial compounds. Federal Register, 68: 11337-11340, March 10.
USDA. (2003) Pre-briefing for reporters on USDA's Federal Register notice on field testing of pharmaceutical-producing plants. March 6. A copy of the pre-briefing transcript available at: http://www.usda.gov/news/releases/2003/03/0084.htm.
Phillip B. C. Jones, PhD., J.D. Seattle, Washington phillipjones5939@msn.com
Source: http://www.isb.vt.edu/news/2003/news03.jun.html#jun0304 4jun03
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