OTA Supports A Revision of Regulations for the Introduction of Genetically Engineered Organisms To Address Ecological Concerns:
Comments of the Organic Trade Association to APHIS Docket No. 03-031-2
Associate Policy Director
March 23, 2004
The Organic Trade Association (OTA) thanks USDA’s Animal and Plant Health Inspection Service (APHIS) for this opportunity to comment. OTA supports a 30-day extension of the comment period to revise and extend our comments.
OTA applauds APHIS for proposing Environmental Impact Statements (EIS) for the introduction of genetically engineered organisms. OTA supports creating an EIS for every class of genetically engineered organism. Finally, OTA urges APHIS to include the following specific considerations when compiling the proposed EIS.
1) OTA notes that the report of the National Research Council of the National Academy of Sciences, "Biological Confinement of Genetically Engineered Organisms," was critical of current safeguards. OTA urges APHIS to address fully all of the concerns in that report in the proposed EIS.
2) OTA specifically urges APHIS to address horizontal gene transfer and the ramifications of the hybridization of plant species with differing numbers of chromosomes. One particularly troubling phenomenon is gene transfer in open fields of canola that has resulted in the creation of herbicide-resistant "superweeds."
3) Because of these and other issues and concerns, OTA urges USDA to disallow crops that contain pharmaceutical drugs and industrial chemicals to be grown outdoors. OTA notes that even if the drugs and chemicals are engineered into non-food crops, the genes could still get into our food supply.
4) In any case, OTA opposes allowing using any food crop for crops genetically engineered to contain pharmaceutical drugs and industrial chemicals.
5) Since horizontal gene transfer and alternative splicing have shown that genes like to move around much more than was previously expected, crops genetically engineered to contain pharmaceutical drugs and industrial chemicals should be restricted to greenhouses or other controlled indoor environments. In addition, crops such as genetically engineered wheat or genetically engineered rice should not be allowed to grow outdoors.
6) The organic agriculture industry must be protected from contamination and damage from genetically engineered crops. By placing a ban on the outdoor growing of all biotech corn, soy, wheat and rice, and all crops genetically engineered to contain the Bt toxin, the USDA will show good faith in the proper regulation of these crops.
7) OTA opposes any ruling by the USDA that allows crops genetically engineered to contain pharmaceutical drugs and industrial chemicals to be grown outdoors.
8) Serious, independent research must be done before allowing any new genetically engineered plants and animals are allowed to be marketed. The burden of proof should be placed firmly on those enterprises proposing new genetic engineering events to prove that each and every genetically engineered product is safe before being introduced into the environment and the marketplace.
9) There should be no tolerance level in food for any genetically engineered crop not approved for food.
10) OTA urges USDA and EPA to jointly develop sufficient disincentives for farmers growing genetically engineered crops, including frequent inspections and the possibility of substantial fines, to ensure compliance with all applicable regulations.
The special case of Bt plants
Insect-resistant plants will inevitably produce insects resistant to those plants. Bt plants have an intrinsic tendency to promote pest resistance because the Bt toxin is produced internally and generally, throughout the life of the Bt plant. This means all Bt plants are inherently plant pests, as they will certainly, over time, diminish not only the effectiveness of external, specific applications of Bt, but also their own effectiveness. This will lead to the loss of Bt as an insecticide.
In addition, soil ecology is certainly changed, and may be damaged, by Bt plant roots exuding the Bt toxin. Ecological studies have shown reason for concern regarding the use of Bt crops in general due to the persistence of the Bt toxin in soil as long as eight months after the crop is harvested. This extended presence of the active insecticide, caused by root exudates, could affect soil ecology.[i]
The Organic Trade Association has commented to USDA, EPA, and FDA, that Bt crops are harmful in many ways to organic agriculture. Organic agriculture uses ecological principles to produce food, but the ecology of Bt plants is rarely given independent, peer-reviewed study.[ii], [iii]
Bt, when used with care not to stimulate insect resistance, is an excellent biological control for corn and cotton insect pests. In fact, Bt is the most widely used biological control in organic agriculture.[iv] The responsible use of Bt involves large, very short-term doses (typically with insect exposure of less than 48 hours). On the other hand, the nature of bioengineered Bt plants is such that less effective doses are created over an entire growing season, resulting in a recipe for insect resistance.
So far, attempts to create a resistance strategy based on planting patterns have not resulted in an effective protocol. This, combined with the lack of an enforcement program, signals that the use of bioengineered Bt plants will lead quickly to significant insect resistance, depriving organic farmers of one of their most useful biological pest controls.
Impending pest resistance to the common Cry1 protein is the reason Aventis developed Cry9 StarLink corn.[v] EPA has, to its credit, expressed the current scientific consensus that the safety of the Cry9 protein in the human food chain is in serious doubt.
Just as there are serious questions about the anomalous expression of fusion genes,[vi] so must the common use of antibiotic resistance marker genes in Bt plants also be addressed as part of a plant pest assessment. The British Medical Association has stated, “There should be a ban on the use of antibiotic resistance marker genes in GM food, as the risk to public health from antibiotic resistance developing in microorganisms is one of the major public health threats that will be faced in the 21st century.”[vii] The American Medical Association has also expressed concerns: “…the use of antibiotic markers that encode resistance to clinically important antibiotics should be avoided if possible.”[viii]
At the very least, USDA should enact a moratorium on support of Bt plants until an independently studied, peer-reviewed method for pest resistance management is ready to be implemented. This could easily be extended to other Bt plants as well, and should be. The few ecological studies that have been done to date show substantial reason for concern and should be sufficient to persuade APHIS to propose a moratorium on the commercial use of all Bt plants until independent, peer-reviewed studies have shown that there are no ecologically harmful effects. These studies would have to provide compelling data on pest resistance; impacts on non-target species; pleiotropic effects; the stability of the transgenic line and the possibility of horizontal gene transfer;[ix] gene flow to wild relatives of corn, cotton, and all other crops for which a Bt form has been developed; and gene stacking.
One recent study has shown than Monarch butterfly larvae may usually be exposed in the field only to non-lethal doses of Bt corn pollen. While good news for the Monarch, this information must also be interpreted as demonstrating the difficulty of implementing an effective insect resistance strategy due to the dispersal of Bt pollen in low doses. Also, pollen dispersal, rather than direct contact with Bt plants, may eventually be shown to be the primary mechanism for creating general insect resistance.
OTA also calls on APHIS to coordinate its work thoroughly with EPA, FDA, and NIH to ensure that the issues of human health, animal health, and environmental and ecological effects are considered comprehensively. This new technology involves whole systems, and it is the responsibility of USDA, EPA, FDA, and NIH, at least, to ensure that no issues are left unconsidered.
Lastly, the use of Bt crops has an economic impact on organic production because pollen drift from Bt plants, leading to gene flow, can contaminate non-bioengineered organic crops. Bt contamination is trespass, a nuisance, unwanted, and can lead to significant economic losses for organic farmers. This is a clear example of potentially disastrous environmental degradation, with the added problem that consumers seeking products that contain no genetically engineered materials may be denied this choice because of inadvertent contamination.
[i] Saxena, D., Flores, S., and Stotzky, G. ( 1999). Transgenic plants: Insecticidal toxin in root exudates from Bt corn. Nature 402: 6761 (December 2, 1999), p. 480.
[ii] A beginning to the ecological study of Bt corn may be found in Obrycki, et al. (2001). Transgeneic Insecticidal Corn: Beyond Insecticidal Toxicity to Ecological Complexity. BioScience, May, 2001.
Among other points APHIS may wish to note, the authors report that “Bt plantings are not being used as a replacement for insecticides but in addition to them.”
[iii] Makhijani, A. (2001). Ecology and Genetics: An Essay on the Nature of Life and the Problem of Genetic Engineering. Washington, DC.: Institute for Energy and Environmental Research.
Makhijani writes in the summary document, “Creating new genomic structures by inter-species genetic engineering would be a very risky proposition under any circumstances, but it is particularly rash in the face of the fundamental gaps in knowledge of how genomic structures express themselves in ecosystems.”
[iv] Walz, Erica. (1999). Final Results of the Third Biennial National Organic Farmers Survey. Santa Cruz: Organic Farming Research Foundation. See p. 80.
[v] Macintosh, Susan C. (2001). Unique Attributes of Cry9C (StarLink) Bt Help Assure Long-Term Viability of Bt in Crop Protection. (Aventis white paper). Web document: http://www.us.cropscience.aventis.com/AventisUS/Cropscience/stage/html/whitepapersl.htm
Macintosh writes: “A possible threat to Bt arises from the potential development of insect resistance to Bt. Now, a new Bt protein called Cry9C, marketed as StarLink, can be used to address those concerns because of its unique composition and characteristics.”
[vi] Leder, A., Pattengale, P.K., Kuo, A., Stewart, T.A., and Leder, P. (1986). Consequences of widespread deregulation of the c-myc gene in transgenic mice: multiple neoplasms and normal development. Cell, May 23, 1986, pp. 485-495.
[vii] British Medical Association. (1999). The Impact of Genetic Modification on Agriculture, Food, and Health. London: Britich Medical Association.
[viii] American Medical Association Council on Scientific Affairs. (2001). Genetically Modified Crops and Foods. Chicago: American Medical Association.
[ix] Ho, M. W. et al. (1998). Microbial Ecology in Health and Disease 10, pp. 33-59; Ho, M.W., Ryan, A., Cummins, J. (2000). Microbial Ecology in Health and Disease 12, pp. 6-11; Ho, M.W., Steinbrecher, R. (1998). Environmental and Nutritional Interactions 2, pp. 51-84; Windels, P., et al. (2001). Eur Food Res Technol DOI 10.10007/s002170100336.