1. Objectives

Teachers Objectives
Using actual cases, provide background on the development and use of genetically modified organisms.

1. Introduce the ethical issues that have emerged from these cases.
2. Offer students the opportunity to identify and articulate an ethical position related to issues in each case study.

Curriculum Integration Ideas
These case studies may be used in life or social science classes where there are units for topics including:

1. Environmental Science
2. Health and Nutrition
3. Genetics
4. Plant Biology, Botany, Microbiology

2. Background
Genetic engineering technology has given scientists the power to do amazing things. Scientists are now able to create entirely new varieties of microorganisms, plants, and animals. By changing or augmenting the genome of an organism, using a variety of methods, scientists have figured out ways to make plants disease-resistant, special animals for experimentation, crops more productive, and food tastier. But all of these advances have corresponding ethical, legal, social, and ecological risks. This high school bioethics brief offers you a set of case studies to examine while you reflect on the ethical issues emerging from advances in genetically modified organisms.

3a. Patenting Life: Chakrabarty

Chakrabarty and the Bacteria That Changed Everything
Oil spills are expensive, time-consuming, and difficult to clean up. Dr. Chakrabarty, a researcher working at General Electric (GE), engineered a bacteria that could break down crude oil. Realizing the obvious commercial potential the bacteria might have, GE sought patent protection over the bacteria. The trouble was that nobody had tried patenting a microorganism before.

The issue of whether nonnaturally occurring, man-made, living organisms could be patented was fiercely debated. Chakrabarty applied for the patent in 1972, and was denied by both the Patent Examiner and the Patent Office Board of Appeals. The Patent Office held that the bacteria were products of nature and therefore not patentable. The Board of Appeals agreed that the microorganisms could not be patented, but did so strictly because the bacteria were living organisms, not because they were products of nature. After more legal wrangling, the issue was finally settled with a 5-4 split decision by the US Supreme Court in 1980. The Supreme Court ruled that the microorganisms could indeed be patented. In doing so the Court stressed that patent laws should be given a wide scope, and that the bacteria was markedly different from any found in nature. The Court rejected the argument that the 1930 Plant Patent Act and 1970 Plant Variety Protection Act, which protected asexually and sexually produced plants respectively, evidenced congressional understanding that living matter could not be patented. The Court further rejected the argument that Congress must explicitly decide whether microorganisms are patentable since biotechnology was unforeseen when patent statutes were enacted.

Dissenting justices argued the decision should have been left to congress and that legislation regarding plant protection illustrated that Congress intended only a subset of living matter to be protected by patents. Since Chakrabarty, hundreds of patents on living organisms (including mammals) have been granted.

3b. Patenting Life: Of (Spliced) Mice and Men
In April of 1988 two Harvard researchers obtained the first patent on a genetically engineered animal. The patent was also the first one issued based on the introduction of a human gene into another animal. The “Harvard Oncomouse” was genetically engineered to be susceptible to cancerous tumors. The patent was very broad, and encompassed “all non-human eukaryotic animals whose germ cells and somatic cells contained an activated oncogen sequence[1].” The patent also covered any progeny from mice that had been spliced with the specific sequence.

Two major events laid the groundwork for the oncomouse patent. First, the Chakrabarty case established that living organisms could be patented. Secondly, in 1987 the USPTO Board of Appeals said that the fact that a multi-cellular animal was involved was not a bar to patentability[2]. On April 21, 1987, the USPTO announced that it would accept applications for "non-naturally occurring non-human multi-cellular living organisms, including animals." The USPTO stated that, to be patentable, the animals must be "given a new form, quality, properties or combination not present in the original article existing in nature in accordance with existing law." The oncomouse clearly met this criteria.

Various groups protested the patenting of animals. The National Council of Churches called the USPTO decision a “matter of deep philosophical and spiritual concern.” Jeremy Rifkin, anti-biotech activists and founder of the Foundation on Economic Trends, called for a halt on further animal patents. Some members of congress agreed with him. However, hundreds of patents have been granted for genetically engineered animals since the late 1980s.

In 1995 the issue of patenting animals came before the European Patent Office (EPO). When the EPO decided to accept the oncomouse patent application in 1992, over 200 organizations including animal welfare groups and environmentalists joined in opposition. Among the moral objections was that Leder’s research constituted animal cruelty. The EPO granted the patent, and sustained it on appeal, though it limited the scope of the patent to rodents only. Over twenty patents on animals have since been approved by the EPO.

4a. Food & Drinks: GM Wine

Should We Play Dionysus?
Florida, the third largest consumer of wine in the US, may soon be able to produce fine wine itself. Currently weather conditions and Pierce’s disease, a lethal disease of grapevine caused by a bacterium spread by certain insects, prevent Floridians from growing popular grapes on a scale needed for wine production. Researchers from the University of Florida are developing strains of grapes genetically modified to be resistant to the disease. If the threat of Pierce disease was removed, one researcher claimed, Florida could grow quality grapevines like cabernet sauvignon and chardonnay. Optimistic estimates put commercialization of GM grapevines at least 5 years away.

California grapevines, particularly in the south, are also vulnerable to Pierce’s disease. Californian wine-growers, who rely heavily on the European market, worry that Europeans will reject wine produced from genetically modified grapevines. Peter Poole, president of the Mount Palomar Winery in Temecula California, believes "it’s very likely for someone to say, ‘this isn’t genuine cabernet sauvignon."

Research into genetically engineering wines with reduce byproducts, especially those that cause headaches, is also proceeding. This research focuses not on the grape, but on the yeast that turns grape juice into wine. Other modifications might increase flavor, but possibility at a destabilization of color. Cultural objections are already mounting, especially among the French. One French winemaker dismissed the concept of GM wine saying, “we are not in the business of making Coca-Cola.” In 1999 Moet and Chandon, a large Champagne maker, stopped work on genetically engineered vines in response to public pressure. Burgundy winemakers believe that GM wines violate "terroir", the concept that particular types of grapes are appropriate solely for certain locations.

4b. Food & Drinks: Starlink Corn
Starlink corn is genetically engineered to produce a protein, “Cry9C”, which bestows resistance to specific species of pests. The protein is a modified version of one produced in nature by the soil bacteria Bacillus thuringiensis (Bt). Other varieties of engineered corn produce exactly the same protein as Bt, and have been approved by the government for both animal and human consumption. In 2000 farmers planted 352,00 acres of Starlink (roughly 0.44% of total U.S. corn acreage).

In 1998, the EPA approved Starlink corn for animal consumption and industrial production of ethanol, but not for human consumption. The reason they barred Starlink from human consumption is that the modification of the protein allows it to resist both heat and digestion. These traits are associated with allergens.

On September 18th, 2000 the Washington Post reported that Starlink corn had been detected in Taco Bell brand taco shells sold in grocery stores. The Starlink was detected when The Genetically Engineered Food Alert (GEFA), a coalition of environmental groups, sent the shells to the Iowa based company Genetic ID for testing. The independent lab reported that the sample taco shells contained at least 1% Starlink corn. Kraft Foods, who distribute the shells, responded the next day with a press conference and a “special report” posted on their web site. Kraft expressed that it was conducting its own tests to confirm the results and would voluntarily recall the shells if Cry9C were detected.

Kraft later confirmed that Cry9C was in the taco shells and recalled the nearly three million boxes of shells presently on sale throughout the US. Subsequently hundreds of types of corn based foods were recalled due to concern about Starlink contamination. It is unknown how Starlink corn ended up in the human food supply. EPA officials have said that Aventis, as condition for its license, had the responsibility to ensure the corn did not get into the human food supply. Aventis has said that it required farmers to sign agreements to use Starlink corn only for animal feed or industrial use. Aventis also claimed that seed bags carried a label detailing these requirements. Despite these measures, critics contend that farmers violated their agreement with Aventis and sold the corn to mills producing flour for human consumption. A survey conducted by Aventis nine months prior to GEFA’s tests revealed that at least two farmers had sold Starlink corn to mills processing flour for human use. Over 12% of farmers responding to the survey said they didn’t know where their corn ended up. An alternate theory of biotech critics is that heavy winds had blew Starlink pollen into fields of conventional corn. The milling company that produced the flour used for the taco shells insisted they had ordered only conventional corn.

Following the discovery of contamination, over fifty people came forward claiming they had suffered allergic reaction to the taco shells. The Food and Drug Administration and the Center for Disease Control (CDC) tested the blood of 17 of these people and found that it was not Starlink corn that had caused their allergic response. Aventis is currently facing lawsuits from consumers claiming they suffered allergic reactions to the corn (including people tested by the CDC, who dispute the test results). Currently about ten cases are pending in three states and cases brought in Federal court are being consolidated into one class-action suit.

In late September, Aventis suspended seed sales of Starlink corn, the first time a biotech company has frozen sales of a genetically modified seed. In an agreement with the US Department of Agriculture, Aventis agreed to buy all remaining Starlink corn to ensure that it would be used only for animal feed and ethanol production (at a cost of roughly $100,000,000). Aventis will not resume Starlink sales in the U.S. until the strain has been approved for human consumption. Critics have questioned EPA’s decision to grant Starlink approval for animal feed and not for human food. Some are asking EPA to withhold approval of biotechnology crops until they have clearance to be used in food.

4c. Food & Drinks: GM Coffee
Researchers at the University of Hawaii have developed genetically modified coffee strains with beans that only complete ripening when they come in contact with a specific chemical (ethylene). The modifications work by disrupting the coffee plants natural ability to synthesize ethylene, the molecule that makes the beans ripen. GM Coffee farmers would grow the beans until they are all almost ripe, and then add the ethylene, ripening all the beans at once. The result would be a field that could be harvested with machines since differentiating between ripe and unripe beans would not be necessary. Currently a Hawaii based company, Integrated Coffee Technologies Incorporated (ICTI), has licensed the technology. They do not plan to begin marketing for at least seven years. As of yet, nobody has tasted the GM coffee.

Attempts to genetically modify coffee are being protested by a group called Action Aid, based in England, who fears the new technology will destroy the livelihoods of hundreds of thousands of low-income workers in Asia, Africa, and South and Central America. The modifications aim to change the ripening process of the coffee beans. Most non-modified strains of coffee beans have to be hand picked because the beans ripen at different times.

Action Aid is attempting to raise awareness about (and support against) the deployment of the new technology. In a 2001 report, Action Aid contends that about sixty million coffee pickers and coffee farmers would be directly affected if the genetically modified coffee became widely used. Action Aid also states that there is no need for the genetically modified coffee as coffee is plentiful and affordable. Critics of GM coffee argue that the new technology will lead to the replacement of small farms with larger corporate farms that use less labor. Action Aid’s website has printable cards stating “GM Coffee. We Don’t Want it. Don’t Sell It” and urges people to place them in complaint boxes at coffee shops. Action Aid’s efforts have led a handful of companies to pledge not to stock GM coffee, although larger companies have refused to do so as of yet. Large coffee companies (Starbucks, Safeway, etc.) do participate in the Fair Trade program that guarantees coffee growers over a dollar per pound of coffee sold (as opposed to roughly 20 cents/pound otherwise).

A representative of ICTI claims that protests have not affected funding or research, and that eventually biotechnology will play a significant role in Latin American coffee production. ICTI also believes that most (90-95%) of the growing areas in Latin America are too steep for machines, but that the 5% or 10% market potential is still large enough to be profitable. According to an ICTI representative, "technological innovation such as our product may be necessary to maintain current levels of production and to remain competitive in the world market."

5. The Forest from the Trees
Creating GM TreesScientists are currently attempting to develop genetically modified (GM) trees that will grow faster, be herbicide resistant, and produce uniform wood more easily converted into paper. The trees might also be more disease resistant and able to grow in extreme environments. Proponents of genetically modified trees believe that GM trees will help the environment and lower production costs. Faster growing plantation trees, they argue, will take pressure off natural forests for paper production. Trees might also be genetically modified to contain reduced levels of lignin, thus lowering chemical pollutants needed for paper production. Herbicide resistance, according to one researcher, could save over 180 millions dollars annually in the United States by lowering the cost of establishing new plantations.

GM trees would be grown in isolated plantations, but environmental groups such as the Sierra Club argue that containment of GM trees may be impossible. The Sierra Club also argues against tree plantations, GM or not, because “a tree plantation is not a forest… [it] doesn’t support chipmunks or snakes at ground level, [it] holds no birdsong in its branches…no raptors soaring above.[3]” Environmental groups also fear that GM trees will become invasive, taking over eco-systems because of their superior characteristics. Opposition has taken the a range of forms, including environmental groups calling for moratoriums and, in July of 2000, activists destroying thousands of experimental GM trees in Maine.

In the US permits for non-contained experiments with genetically engineered trees must be obtained from the USDA’s Animal and Plant Health Inspection Service. Since 1987 there have been over 300 trials using genetically modified trees. Leading the pack is Oregon State University, which has obtained over 100 permits exploring mainly herbicide tolerance. Recently North Carolina State University obtained a $4.4 million dollar grant from the National Science Foundation to map the genes of pines. Michigan Technical University has obtained over ten permits working to reduce lignin content. Companies, including Westvaco, Union Camp, and Monsanto, are also working on developing genetically modified trees[4].

6. Food for Thought

1. Do you think it is right for companies to create and patent a ‘new’, genetically engineered organism?
2. Do people have the right to own life forms they create? If so, are bacteria and mice different then say primates or engineered human beings? Why?
3. What ethical issues emerge when considering the potential impact of genetically engineered microorganisms and plants on the environment?
4. Do you agree with the Sierra Club when they claim that GM forests are somehow ‘less special’ than natural forests? Why or why not?
5. Do the increases in productivity and decreases in costs justify the creation of GM forests for paper production? Why or why not? What are the risks? What are the benefits?
6. Current product labeling usually does not include information about the genetic technology that went into making or growing the food product. Do you think this information should be included in a label? Why or why not?
7. Starlink corn somehow ended up in the human food supply. Who should bear responsibility when such contamination occurs? Farmers? Seed manufactures? Food manufacturers? The Food and Drug Administration (FDA), Centers for Disease Control (CDC), Department of Agriculture? Consumers?
8. Given the risk of contamination, should farmers be allowed to grow products (i.e. livestock feed) that are not approved for human consumption?
9. Do you think genetically modified plants should be developed if the technology threatens to eliminate thousands (or hundreds of thousands) of jobs? What if the product is of a much higher quality, and relatively few jobs are eliminated? What if the quality is the same, and 100,000 jobs are eliminated effecting the lives of families around the world?