A Publication of:
The Science and Environmental Health Network (SEHN)
The Institute for Agriculture and Trade Policy (IATP)

written by:
Katherine Barrett (SEHN)
and Gabriela Flora (IATP)

March 2000

Many different terms are used to describe the process of genetic engineering and related technologies. These terms are not always used consistently so it is important to be specific about the processes in question.

"Genetic engineering" most often refers to a technique used to transfer small fragments of genetic material (genes which are composed of DNA) from one organism to another. This re-combining process is also called "recombinant DNA" (or rDNA) technology. It can be thought of as a cut-and-paste process in which a specific gene is "cut" from a donor organism and "pasted" into the genetic material of another organism (plant, animal or microbe). The transferred gene carries a new characteristic or trait that is expressed in the engineered organism.

If the genetic material is transferred between different species or kingdoms (for example between bacteria and plants), the resulting engineered organism is called "transgenic". However, not all GE crops are transgenic. Genetic engineering can be used to remove, modify, and reinsert DNA. For example, the Flavr Savr delayed-ripening tomato was developed by disabling a gene already contained in the tomato.

Other terms such as "genetic modification" and "biotechnology" are often used in place of "genetic engineering". However, these broader terms are sometimes also used to refer to any technology that alters the genetic make-up of organisms or that uses living organisms to make products. Under this broad definition, crop hybridization or selection of yeast strains for brewing as well as rDNA technology would be considered "biotechnology". This can be misleading as there are important differences between moving isolated genes among organisms and broader practices that have been used for centuries.

Some of the traits engineered into GE crops are similar to those that have been selected for, or bred into non-GE crops (for example, herbicide tolerance). However, genetic engineering is different from traditional breeding (hybridization and crop selection) in several significant ways:

• GE enables the transfer of single or a few genes among organisms that would not otherwise exchange genetic material (for example, bacteria and corn, or viruses and squash). Therefore, the new gene can code for proteins and expresses traits that could not be bred into a crop (for example, the Bt toxin). Crop hybridization involves crossing closely related plants, for example two varieties of the same crop and generally involves exchanging different versions of the same gene (called "alleles"), rather than adding an entirely new genetic trait.
• In addition to adding the desired new genetic trait, GE introduces other foreign materials into the host organism. These usually include a marker gene (most often antibiotic resistance) so a successful insertion can be identified, regulatory sequences (such a promoter sequences to �switch on� the new genes), and portions of the vector (viruses, plasmids or mobile elements) which are used to transport the new genes into plant cells.
• While genetic engineers can isolate a specific gene for insertion into an organism, the location of the inserted gene into the recipient genome cannot be well controlled, nor can stable expression of the gene be guaranteed.[1] These insertions commonly cause mutations in nearby sections of DNA that can create new unintended traits.[2]
• GE crops have been developed and commercialized more rapidly than any other agricultural technology, and much faster than natural processes of selection and evolution. The time scale of laboratory and greenhouse experiments is not a good predictor of evolutionary changes that occur over many generations.

• Crops: The majority of GE crops currently on the market are soybean, corn, cotton, canola, and potato. Other GE crops such as flax, squash, papaya, and tomato have also been commercialized in the US and/or Canada. Many more GE crops are in the field-testing stage of development, for example alfalfa, apple, cucumber, melon, rice, strawberry, sugarbeet, sunflower, walnut, and wheat.
• Traits: About two thirds of commercialized GE crops are engineered for tolerance to herbicides (such as Roundup, glufosinate or bromoxynil). About one third are engineered for insect and virus resistance (for example, resistance to the European corn borer or mosaic viruses). A small number of commercialized GE crops are engineered for quality traits such as altered oil production in canola or delayed ripening in tomato. Moat research to date has not been focused on improved nutritional value, however crops containing vaccines and vitamin supplements are under development.
• Acreage: GE crops were first grown on commercial scales in the mid-1990s. By 1999, world-wide acreage had increased to almost 100 million.[3] The US, Argentina, and Canada are the world�s largest producers of GE crops. The Agricultural Resource Management Survey found that in 1998 38% of corn, 57% of soybeans and 65% of cotton raised in the US in 1998 were GE.[4]

The vast majority of GE crops have been developed for agronomic purposes not increased nutritional value. Evidence from several scientific studies indicates that GE foods may have adverse effects on human health. Such potential effects include:

• Allergic responses and/or toxic effects. New proteins expressed in the GE crop may cause allergic or toxic responses in susceptible people. Known allergens may also be transferred to new foods.[5]
• Antibiotic resistance. Many GE crops contain genes that code for resistance to antibiotics as well as the genes that code for agronomic traits. Antibiotic resistance is used during the development process as a "marker" to identify plants that have successfully incorporated the new traits. However, there has been concern that antibiotic resistance factors in the human gut could neutralize antibiotics prescribed by a physician.[6] Further, there are unresolved concerns that these antibiotic resistance genes may be inadvertently transferred to micro-organisms.[7] This transfer could reduce the efficacy of existing antibiotics by creating resistant strains of bacteria.

Scientific research and farmers' reports also suggest that GE crops could have adverse environmental effects, including:

• Increased invasiveness and/or persistence of crops in agricultural and non-agricultural locations due to herbicide resistance.[8]
• Spread of the engineered gene into related plant populations through cross-pollination.[9]
• Development of insect populations that are resistant to the GE trait, for example, corn borer populations developing resistance to Bt.[10] This would render natural control mechanisms such as Bt (used in spray form by organic farmers) ineffective and increase farmers� dependence on the development of new and/or chemical-based products. The US government has recently imposed farm-management processes to delay the development of resistance in corn fields. Farmers are now required to plant areas of non-Bt corn, and to monitor for resistant insect populations.[11] It is unclear whether this approach will be effective.
• Unanticipated effects on "non-target" organisms. For example, some GE crops have been shown to adversely affect beneficial predatory insects (such as ladybugs) or benign insects (such as monarch larvae).[12] GE crops may also affect soil organisms although in-depth studies have not yet been conducted.[13]
• Development of new plant pathogens. If crops engineered with viral genes are infected with a second, different viral pathogen, an entirely new strain of plant viruses could be produced by mixing of the genetic information from the two viruses.[14] There is growing speculation that similar processes may also create new human pathogens.

Widespread use of GE crops may also have adverse social and economic effects.

• Agronomics. While promoters of GE claim increased yields, decreased use of chemicals and thus increased profits for farmers, evidence of these benefits is inconclusive. Some studies have revealed that under specific conditions, GE crops do produce benefits,[15] while other studies indicate that the performance of GE crops is below that of conventional crops.[16] Economic benefits or costs to farmers will largely depend on local growing conditions (e.g. climate, soil types, and pest infestation levels), crop management practices, seed and technology costs, development of insect or weed resistance, and market demand.[17]
• Loss of markets. Due to public health and environmental safety concerns about GE crops in Europe, Asia and other countries, as well as more stringent and comprehensive regulations abroad, international markets for GE crops have rapidly declined. Within the US markets for GE crops are also shrinking. A.E. Staley, the second largest corn processors in the US, announced in April 1999 that it will not accept non EU-approved GE corn. And in September 1999, ADM asked its grain suppliers to segregate GE and non-GE corn and soybeans. In response to consumer demand, Gerber (owned by Novartis) and Heinz, the two leading manufacturers of baby foods in the US, announced in July 1999 they will ban GE soybeans and corn from their baby foods. In January 2000 Frito Lay informed its contract farmers that they will not accept GE corn. Enfamil, one of the nation's leading infant formula companies, announced in March 2000 that their products will be GE-free. It was revealed in April 2000 that US potato processors along with many fast food chains are no longer purchasing GE potatoes. North American farmers who have adopted GE technologies must find domestic markets that remain open to GE crops, segregate their crops and/or accept the loss.
• Food security. Almost all GE crops are owned by private sector corporations (all but one commercialized GE crop in Canada and the US are privately owned). Recent mergers among seed and chemical companies, and patents on GE technologies, have placed the control of crop production into very few hands. Among the major players are Novartis, Monsanto, Dupont/Pioneer, Dow AgroSciences, Astra Zeneca and Adventis. Removing control from farmers and traditional breeders could affect food security and independent family farmers� survival by:

• Curbing the development and maintenance of traditional crop varieties and farming methods that are needed to support biological and cultural diversity.
• Encouraging agricultural research suited to private, rather than public interests.
• Restricting seed saving and sharing through strict contracts and/or technologies (e.g. "terminator" or "traitor" technologies).
• Obligating farmers to pay royalties on patented seeds.
• Promoting technologies suited to large-scale, monoculture farming but not well suited to small-scale, community-based and diversified farming.

• Liability. Farmers should be aware of liability issues if they choose to raise GE crops. Technology agreements and contracts should be read carefully. Some farmers have had legal difficulties with seed companies (e.g. being sued for allegedly saving or reselling GE seed) and some have taken legal action against seed companies for the failure of GE crops. Farmers growing GE crops should also be aware that they could be held liable for pollen drift into non-GE fields. Similarly, farmers who choose to raise non-GE crops intended for GE-free markets could be held liable if crops test positive for GE. These farmers should be careful in promising a completely GE-free product and should be aware of methods to limit exposure to GE pollen. Currently, crop insurance is not available for genetic drift.

Despite recent studies, the hazards and benefits of GE crops remain difficult to predict and measure accurately. This uncertainty is due to several factors including the complexity of genetic, ecological, and social systems in which GE crops are used, the unprecedented rate at which GE crops have been released into the environment and marketplace, and the lack of long-term and broad-scale studies on potential impacts. Therefore, research programs and regulatory policies must consider the potentially serious -yet highly complex and uncertain - environmental and public health effects that may result from broad-scale use of GE crops.

There are three federal agencies that review different components of GE organisms. The Department of Agriculture (USDA) regulates the safety of plants and potential plant pests; the Environmental Protection Agency (EPA) regulates GE micro-organisms and pesticides; and the Food and Drug Administration (FDA) regulates the safety of GE organisms intended for human or animal food. Products are regulated according to their intended use, with different traits of some products being regulated under different agencies.

• Within the USDA, the Animal and Plant Health Inspection Service (APHIS) is responsible for protecting US agriculture from pests and diseases. There are two stages in the regulatory process for GE plants.
• Small-scale confined field trials are approved through a "notification" process.[18] GE crops eligible for this fast-track process must meet six safety-related criteria as well as performance criteria to ensure confinement.
• A more comprehensive "petition" process is required for large-scale, unconfined release and commercial sale. Approval through this process exempts that particular GE crop -and its offspring- from further regulatory review. Guidelines for filing a petition are outlined by APHIS.[19] However, applicants are not required to fulfill all criteria. According to APHIS, an applicant "may choose whether or not to follow a particular element in the guidelines."
• The EPA regulates the safety of all pesticides and all GE micro-organisms. This includes GE plants containing pesticides (such at Bt crops), microbial pesticides (such as Bt sprays) as well as chemical pesticides. Microbes intended for environmental clean-up (bio-remediation) and levels of herbicide residue allowed on new herbicide-tolerant crops are also controlled by the EPA. Particular biotechnology products are regulated under a number of different federal Acts under the EPA.[20] However, none are written to specifically address GE crops.
• The FDA regulates foods and feed derived from new plant varieties under the Federal Food, Drug and Cosmetic Act (FFDCA). In 1992, the FDA issued a policy statement to clarify the FDA's position on foods derived from GE plants. According to the FDA, GE foods require regulation and labeling only if they contain substances with a "significantly different" structure, function, or quantity than substances found in non-GE food.[21] The FDA has determined that most GE crops developed to date do not fall into this category and therefore do not require pre-market approval. The FDA does, however, encourage developers of GE foods to consult with the agency on safety and regulatory questions. To date, the FDA has required no GE foods to be labeled as such.[22] ***In May 2000 the Clinton Administration announced proposed changes in the FDA policy which would require companies to consult with the FDA and would make industry conducted test results available to the public. However, no criteria has been established for this consultation and industry will continue to define the tests conducted.***

U.S. regulations for GE organisms are grounded in several principles that, we suggest, are inadequate to evaluate potential hazards.

• Risk Assessment. Regulations aim to determine the level of risk imposed by GE crops and balance that risk with potential benefits. The overall aim is to determine a level of "acceptable risk" compared to non-GE foods already on the market. The process of risk assessment was originally developed for well-defined technologies where impacts have limited scope (for example bridge construction). These risk-based approaches were not designed for predicting impacts in complex, open systems such as ecosystems, and are not well suited for this task.
• Fragmented Regulation. No single government agency is responsible for regulating all GE organisms or all uses of a particular GE organism. This fragmented approach tends to ignore complex, additive and systems-level effects (for example, introducing several genes with different functions into one crop). Public awareness and participation is also more difficult in a fragmented regulatory system.
• Product-based regulation. GE organisms are assessed according to the characteristics of the final product, not according to the process by which they were developed. In other words, the techniques of genetic engineering are not seen as more hazardous than other techniques such as traditional breeding. In contrast, the European Union, has adopted process-based policies that require all GE organisms to undergo regulatory review.
• ****Substantial equivalence and familiarity. These concepts were first developed by the UN Food and Agriculture Organization and have been adopted in US policies on GE organisms. Substantial equivalence means that many GE organisms are considered to be the same as non-GE organisms. Familiarity means that there are no significant differences between GE and non-GE organisms. Both concepts do not require new or different regulatory practices for GE organisms. Pre-market testing is required only when a GE food is deemed to be significantly different from existing foods. This policy does not adequately address significant differences between GE and non-GE crops, as outlined above.
• Proponent�s discretion. According to the above principles, most GE foods and crops do not require extensive testing prior to commercialization. Testing that is done is usually conducted by those who will financially benefit from the commercialization of their GE products. The full results of these tests are not available to the public as they are classified as "confidential business information" or trade secrets. There is no independent testing to verify industry conducted tests.

The precautionary principle is the notion that when an activity raises threats of harm to human health or the environment, precautionary measures should be taken even if some cause-and-effect relationships are not fully established scientifically.

The principle was first developed and applied in Germany in the 1970s. Since that time, the principle has been incorporated into many international declarations and national policies on the environment, and has been used to address issues such as acid rain, global warming, marine pollution and sustainable development.

The precautionary principle has been negotiated in several recent international trade discussions about GE foods and crops. The European Commission generally supports the precautionary principle.[23] The US Commerce, State, and Agriculture Departments generally object to the precautionary principle, while agencies such as the EPA have not voiced a clear opinion. The result is often confusion, with "precaution" being redefined, watered down, or conflated with other issues such as trade protectionism. However, the approval of the Biosafety Protocol in January 2000 establishes an international regulatory regime based on the precautionary principle to manage the unique risks of GMOs. Once the Protocol is ratified by 50 countries, the precautionary principle becomes enforceable in international law.

The precautionary principle in its basic form is a scientifically sound and sensible approach to new technologies. Core elements include the following:

• A primary goal of society is to protect the environment and public health.
• Proactive measures should be taken toward this goal even in the face of scientific uncertainty.
• The burden of demonstrating the safety of a potentially harmful technology falls on its developers, rather than on the public or government.
• Alternatives must be considered.
• Open, informed, and democratic processes must be used to make decisions about the acceptability of technology, its demonstrated safety, alternatives, research, and policy goals as well as the processes to achieve these goals.

The principle of precaution applies to the introduction of GE crops because:

1. There is recognized potential for serious harm. "Serious" refers to long-term, broad-scale, persistent, accumulative, and/or irreversible harm. In other words, the precautionary principle applies when the stakes are high.
2. Despite recognition of potentially serious harm, there remains significant uncertainty about the nature, extent, and severity of the hazard so that precise measurements and effective control mechanisms are not presently feasible.
3. The situation entails highly complex interactions among many dynamic systems (including ecological, social, and value systems) so that a precise safety evaluation does not require simply more research and more regulation, but research and regulation of a significantly different kind.

The precautionary principle is most effective when it is applied before a potentially hazardous technology is introduced. Because GE crops are already planted worldwide, we should adopt precautionary measures that anticipate and avoid negative effects of existing as well as proposed future introductions. These measures should encompass both research and policy agendas.

Research: The precautionary principle is not simply a way to say "No" to an activity. Rather, precaution requires active and ongoing investigation of the potential hazards and benefits of technologies, as well as thorough consideration and evaluation of alternatives. Research that is consistent with the precautionary principle:

• Examines long-term and broad-scale effects (for example, studies would be conducted over several crop generations and geographic areas).
• Investigates indirect and cumulative impacts such as effects on beneficial predators and soil microorganisms.
• Includes regular monitoring of field trials and releases, and accurate feedback of information to guide further research.
• Aims to identify and avoid worst-case scenarios.
• Is informed by a wide range of perspectives and experiences including those of ecologists, farmers, economists, and ethicists.
• ***Promotes understanding and characterization of existing ecosystems. This research is essential to understanding the environmental impacts of genetic engineering
• Investigates feasible and acceptable alternatives to GE crops.
• Openly acknowledges uncertainties that may qualify research results, as well as commitments that may bias the design and conduct of research.

Policies: Just as research programs are guided by government policies, effective and appropriate policies also require a solid foundation in research. Applied to agricultural policy, the precautionary principle may include the following measures:

• Provide incentives and funding for public research on the hazards and benefits of GE crops as described above.
• **Provide incentives and funding for public research characterizing existing ecosystems.
• Support and encourage diversity in agriculture, both in terms of the crops produced and in terms of agricultural processes (for example, providing adequate funding for non-GE agriculture including organic and low-input sustainable approaches).
• Protect food security and ensure public control of agriculture by limiting the scope of patents, plant variety protection, and plant breeders� rights.
• Place the burden of responsibility on the developers of potential hazardous technologies to show -through an open process- that the technology is both necessary and reasonably safe. Ensure that decision-making is open and receptive to input from all interested parties.

Agricultural genetic engineering is a complex issue that can have multiple impacts on public health, the environment, the structure of agriculture, and community economic viability. The precautionary principle is a useful concept to help us understand such complex issues. It can also be a guide to action. Citizen dialogue and participation in policymaking on GE is essential to ensure that we maintain a healthy sustainable food and agriculture system and a democratic society.

Comprehension of the issues is important for making both individual decisions, such as what to feed one�s children and what seed to purchase and plant, and collective decisions, such as where to invest public research dollars and what food to serve in public schools.

With a presence in virtually every county in the nation and its close link to relevant research through the Land Grant system, Cooperative Extension serves as a trusted source for exploring controversial issues such as GE. Facilitating dialogue on GE is consistent with Extension�s proud history of public policy education. This is an opportune time for Extension to exercise leadership on an issue that is of concern to a growing number of farmers and consumers. Extension can help guide rural and urban communities through the GE maze and, at the same time, confront the challenges of the current low return on agricultural commodities by:

• Bringing communities and local organizations into the public policy debate by organizing educational programs on the precautionary principle and its relation to GE products.
• Working with farmers and agribusiness leaders to increase awareness of the perceptions and demands of consumers related to GE foods, both internationally and within the United States. This could include bringing consumers and producers together to understand each other�s perspectives on GE-related issues.
• Working with farmers and farm groups to develop alternative marketing channels for GE and non-GE crops.
• Helping farmer groups and elevator operators understand the standards for GE-free grains to guarantee access to premium GE-free markets, thereby strengthening value-added agriculture. Among other things, this would involve increasing awareness of the implications of GE pollen drift on GE-free grains intended for the growing GE-free markets.
• Assisting farmers to understand their potential liability related to the use of GE seed and the risks of guaranteeing GE free products.

For more information and references on:

• The hazards and benefits of GE crops, see:
  www.biotech-info.net

• US regulations and trade implications, see IATP websites:
  www.iatp.org
  www.sustain.org/biotech/

• Risk assessment and the precautionary principle, see:
  www.sehn.org

• Information for farmers on GE crops, alternatives, management options, and profitability:
  www.cropchoice.com
  http://www.genetic-id.com/

Or contact:

Institute for Agriculture and Trade Policy
2105 First Avenue South
Minneapolis, MN 55404
612-870-3417
[email protected]

Science and Environmental Health Network
Rt. 1, PO Box 73
Windsor, ND 58424-0073
[email protected]

1 http://www.consumer.org/food/widecpi200.htm

3 International Service for Acquisition of Agri-Biotech Applications (ISAAA; www.isaaa.org)

4 http://www.econ.ag.gov/whatsnew/issues/biotech/Table4.pdf

5 Nordlee, J.A. 1996. New England Journal of Medicine. 334:688-692.

6 British Medical Association. 1999. Statement on genetically modified organisms. Press release. May 18. Gebhard, F., Smalla, K. 1998. Applied and Environmental Microbiology. 64(4):1550-1554. Gabriela- review NAS study to see if it can be included here.

7 Syvanen, M., Kado, C.I. 1998. Horizontal gene transfer. London: Chapman & Hall.

8 M. MacArthur, M. 2000. Wester Producer. February 10. Robert, S., Baumann, U. 1998. Nature. 395:25-36.

9 Mikkelsen, T.R., Andersen, B., Bagger-Jorgensen, R. 1996. Nature. 380:31.

10 Gould, F. 1998. Annual Review of Entomology. 43:701-726. Mellon, M., Rissler, J. 1998. Now or never: serious new plan to save a natural pest control. Union of Concerned Scientists. Cambridge, MA.

11 See: http://www.epa.gov/pesticides/biopesticides/otherdocs/bt_corn_ltr.htm

12 Hilbeck, A., Baumgartner, M., Fried, P. M., and Bigler, F. 1998. Environmental Entomology, 27(2), 480-487. Birch, A. N. E., Geoghegan, I. E., Majerus, M. E. N., Hackett, C., and Allen, J. 1996-7. Scottish Crop Research Institute Annual Report 1996-7, 68-72. Losey, J.E., Rayor, L.S., Carter, M.E. 1999. Nature. 399:214.

13 See: Nature, December 2, 1999, page 480; http://www.biotech-info.net/risks.html#soil

14 Greene, A.E., Allison, R.F. 1994. Science. 263:1423-1425.

15 See: http://www.econ.ag.gov/whatsnew/issues/biotech/ or http://www.econ.ag.gov/whatsnew/issues/gmo/index.htm

16 See: http://www.biotech-info.net/RR_yield_drag_98.pdf or http://www.uky.edu/Agriculture/Agronomy/files/news/agvl32_2.pdf or http://www.oac.uoguelph.ca/www/CRSC/faculty/eac/10reasons.htm

17 http://www.agry.purdue.edu/ext/corn/news/articles.00/GMO_Issues-000203.html

18 See: http://www.aphis.usda.gov/biotech/usergdn.html

19 See: http://www.aphis.usda.gov/biotech/petguide.html

20 See: http://www.aphis.usda.gov/biotech/OECD/usregs.htm#epalaw

21 There is currently a lawsuit against the Food and Drug Administration (Alliance for Bio-Integrity, et al. v. Shalala, et al., Docket No. 98-CV-1300 (CKK)) which alleges that under current FDA law GE foods should be labeled. The lawsuit incorporates FDA internal memos and reports where FDA scientists state that GE food is not equivalent to non-GE food. See: http://www.biointegrity.org/list.html and http://www.centerforfoodsafety.org/li/GEexec.html

22 See: http://www.aphis.usda.gov/biotech/OECD/usregs.htm#epalaw or http://vm.cfsan.fda.gov/~lrd/biotechm.html

23 Commission of the European Communities. 2000. Communication from the Commission on the Precautionary Principle. COM (2000)1. Brussels.