Federal Regulation of GE Crops
7. How does the government regulate GE crops?
8. Who ensures that GE crops can be safely eaten by humans or animals?
9. What should the government be doing to ensure the food safety of GE crops?
10. Which agencies regulate the environmental safety of GE crops?
11. Is the U.S. government adequately ensuring that GE crops are safe for the environment?

The Benefits and Risks of GE Crops
12. Are there benefits from current GE crops?
13. What are the main health concerns related to GE crops?
14. Can GE foods cause new allergies?
15. What was Starlink corn and was it allergenic?
16. What are the major environmental risks from the growing of GE crops?
17. What was the controversy about GE corn and Monarch butterflies?
18. What was the controversy concerning GE corn in Mexico?

Future Agricultural Applications of Biotechnology
19. What new GE crops are being developed?
20. Will plants be engineered to produce pharmaceuticals and industrial chemicals?
21. Will there be GE animals in the future?

Background on Genetically Engineered Organisms in Agriculture

1. What does it mean to "genetic engineer" an organism?

When scientists genetically engineer a plant or animal, they remove a copy of a gene from one organism and transfer that gene to a different organism. The new gene becomes integrated into every cell of the organism and is inherited by the crop's offspring. In most cases, the new gene produces a new protein in the cell, which then provides the organism with some useful trait.

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2. What kinds of traits have been engineered into agricultural crops?

Most of the commercial genetically engineered ("GE") crops grown in the United States contain genes that provide either pest resistance or herbicide tolerance. GE corn and cotton contain Bt genes from the soil bacterium Bacillus thuringiensis. The proteins produced from those genes kill certain insect pests when the proteins are ingested by those insects, eliminating the need to kill those pests with chemical pesticides.

GE soybeans, corn, canola, and cotton contain one of several bacterial genes that protect the crop from particular herbicides. Those genes allow certain herbicides to be applied to the crop without harming it, giving farmers more flexible use of herbicides to control weeds.

Finally, some varieties of squash and papaya have been engineered with plant virus genes that render those crops resistant to those plant viruses.

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3. How prevalent are genetically engineered crops?

In 2003, approximately 40% of all field corn (mostly used for cattle feed), 80% of all soybeans, and 73% of all cotton grown in the United States was genetically engineered. U.S. farmers also grew small amounts of genetically engineered papayas, summer squash, and insect-resistant sweet corn.

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4. Am I currently eating genetically engineered foods?

Although most soybeans and a large percentage of field corn are genetically engineered, the harvest from those crops goes primarily to feeding livestock animals, such as cows, pigs, and chickens. Some genetically engineered corn and soybeans, however, does get used for human food products. Field corn is used to make corn meal for products like muffins, corn chips, and tortillas. Field corn is also used to produce high-fructose corn syrup used to sweeten soda pop and other sweetened drinks and corn oil that might be used for cooking or baking.

GE soybeans are processed to make soybean oil and soy lecithin, an emulsifier used in many foods. GE canola and cotton are also processed to produce canola oil or cotton-seed oil, both of which are used for cooking. Therefore, many processed food products that you might buy at the supermarket contain ingredients that were derived from GE corn, soybeans, canola, or cotton.

Although products such as soy oil or fructose sweetener were produced from GE crops, the process of producing the oil or corn syrup from the crop eliminates virtually all of the transgene and its protein product. Thus, Americans consume daily foods with ingredients derived from genetically engineered crops, but our diets actually expose us to very little of the engineered gene or its product.

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5. Are genetically engineered foods safe to eat?

GE food companies and others have conducted a number of tests to determine food safety and that testing has not uncovered any evidence of harm. Those tests have included short-term high-dose animal feeding studies of the GE protein, determining whether and how quickly the GE protein is broken down in the stomach (which prevents exposure to the rest of the body), and testing the levels of a number of naturally occurring plant components to make sure they have not been changed in the GE crop. While some of the tests have not always used the best available methods, together the results indicate that current GE crops are safe.

In addition to safety testing, other information about current GE proteins suggests that they are unlikely to cause harm. For example, the bacterial protein added to herbicide tolerant soybeans is very similar to a protein already found in soybean and other plants and functions in a similar manner. The Bt protein in insect-resistant plants comes from a bacterium used by organic food growers for many years (although, because it is produced continuously throughout the transgenic plant, we would consume more of it than when applied occasionally by organic growers). GE virus-protected crops contain plant viral components that we commonly eat in naturally virus-infected plants without harm.

Finally, GE crops have been grown and consumed by Americans since 1996 with no apparent ill effects. However, since no monitoring of GE food consumption is conducted, some adverse effects, such as food allergies, could go undetected or could be mistaken to have other causes.

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6. Can Americans avoid eating food produced from genetically engineered crops?

Although the currently grown GE crops and the foods made from them are as safe as their conventional counterparts, some people want to avoid eating foods made with such crops. That is not easy to do in the United States because food manufacturers are not required to label whether their products have any ingredients that were genetically engineered. Thus, it is impossible to know whether most products do or do not contain a genetically engineered ingredient. Some manufacturers have voluntarily labeled that their products do not contain any genetically engineered ingredients, but no government or third-party verification system exists to ensure the accuracy of those label claims. In addition, many of those voluntary label claims are misleading, since they falsely imply that the food made without GE ingredients is somehow safer than or superior to the same product made with GE ingredients.

If one wants to avoid GE crops, the best way to do that is to buy "organic." If a product is certified as "organic" under federal standards, then the crops used in that product cannot be genetically engineered. Thus, products produced from organic crops will contain either no genetically engineered ingredients or only inadvertent trace amounts of genetically engineered ingredients.

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Federal Regulation of GE Crops

7. How does the government regulate GE crops?

The Federal government decided in 1986 that the United States Department of Agriculture ("USDA"), the Environmental Protection Agency ("EPA") and the Food and Drug Administration ("FDA") would regulate GE crops using existing statutes. It is the responsibility of those government agencies to make sure GE crops are safe for humans, animals, and the environment. In particular, the FDA is responsible for the food safety of GE crops, while the USDA is responsible for ensuring that GE crops don't harm agriculture or the environment. The EPA is responsible for the safety of pesticides, including plants such as Bt corn or Bt cotton, which have been engineered to produce a pesticide.

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8. Who ensures that GE crops can be safely eaten by humans or animals?

The FDA is responsible for ensuring that all the foods we eat are safe. However, the FDA does not have any special legal authority to approve GE crops before they are commercialized. Thus, FDA regulates GE food and feed crops through a voluntary notification process rather than by a mandatory pre-market approval process. In that voluntary process, the developer of a GE crop submits to FDA a summary of data that shows that the GE crop is substantially equivalent to its traditionally bred counterpart. FDA reviews the submitted data and alerts the developer to any concerns it has about the developer's food safety assessment.

A recent report of FDA's oversight of GE food safety by CSPI found that the process is not as rigorous or as independent as it should be, and that FDA often does not get all of the data it needs to perform a well-informed safety review Plugging Holes in the Biotech Safety Net.

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9. What should the government be doing to ensure the food safety of GE crops?

Before any GE crop is turned into food, the FDA should have to formally approve that crop as safe for human and animal consumption. Congress needs to amend the Federal Food, Drug, and Cosmetic Act to require a mandatory pre-market approval process that is open to public participation and review. Senator Richard Durbin (D- Il.) introduced legislation that would give FDA such authority in 2002 (S. 3095) and he is expected to reintroduce a similar bill.

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10. Which agencies regulate the environmental safety of GE crops?

If a crop has been engineered to make its own pesticide (such as the Bt corn or Bt cotton), then the EPA reviews and approves the safety of that crop before it is commercialized. In its regulatory process, EPA performs a risk assessment to determine the benefits and risks to the environment from the crop and imposes any conditions it believes are needed to minimize or eliminate any potential harmful effects on the environment. EPA's approval process also assesses the safety to humans and animals if they eat the pesticidal compound. EPA establishes a safe tolerance level below which the pesticide is considered safe.

For all other genetically engineered crops (such as herbicide-resistant canola or soybeans), USDA is responsible for ensuring that growing those crops will not have an adverse effect on agriculture or the environment. USDA has established a notification and permitting process for field trials with engineered crops that developers must comply with before planting any GE crop on open fields. USDA also has established a regulatory process that allows developers to petition the agency to deregulate its GE plant, allowing crops to be grown commercially without any regulatory restrictions or requirements. To date, over 9,000 field trials have gone through the USDA's regulatory procedures and over 75 crops have been deregulated.

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11. Is the U.S. government adequately ensuring that GE crops are safe for the environment?

The short answer is no. Although USDA has regulatory oversight over all releases of GE crops into the environment, most field trials get little government scrutiny and only a handful get an individual environmental assessment. That is particularly problematic for crops engineered to produce non-food substances, such as an industrial compound or a pharmaceutical. Thus, before any genetically engineered plant is grown in the open, USDA should conduct a thorough environmental review. In addition, that review process should be open to the public so that any person can review the safety data submitted by the applicant and provide comments to USDA before the agency makes its decision.

For plants producing a pesticide, EPA usually conducts a thorough environmental assessment of that crop before it is allowed to be used commercially and allows the public to participate in that process. EPA's regulatory process could be improved by requiring more field testing as well as by establishing specific testing guidelines unique to GE crops. Currently, EPA uses ad hoc standards for GE crops, since its existing testing guidelines developed for chemical and microbial pesticides are usually not applicable.

To protect the environment, EPA and USDA should implement rigorous post-approval oversight of GE crops. Both agencies have not done a good job at ensuring that after GE crops are released into the environment, those crops don't harm the environment. Both agencies need to regularly inspect field trials to ensure that they comply with government-imposed restrictions and severely penalize violators. In addition, EPA needs to ensure that farmers comply with insect refuge requirements for Bt crops. A 2003 report by CSPI found that approximately 20% of Midwest farmers did not comply with government planting restrictions for Bt crops Planting Trouble: Are Farmers Squandering Bt Corn Technology?. Without better compliance with government restrictions, insects more readily could develop resistance to the Bt crops. If that happens, both the Bt crops and Bt microbial insecticides used widely by organic and other farmers would lose some of their effectiveness.

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The Benefits and Risks of GE Crops

12. Are there benefits from current GE crops?

The benefits from GE crops are sometimes difficult to determine. However, several benefits seem well substantiated. The use of Bt cotton in several regions of the United States has substantially reduced the use of broad-spectrum and highly poisonous insecticides. Thus, Bt cotton provides significant environmental benefits because it has a less detrimental effect on the environment than the pesticides it replaces. Similar benefits have been documented when Bt cotton has been used in China and other countries.

Herbicide-tolerant soybeans have simplified farming for farmers, saving them time and allowing them to attend to other matters. Those the evidence is mixed, the use of herbicide-resistant soybeans may have contributed to the adoption of conservation tillage, which conserves soil which is more easily eroded when fields are conventionally cultivated. In addition to conservation tillage, GE soybeans require on average about one less application per year compared to other herbicides. Therefore, RR soybeans save resources used in herbicide applications.

Whether Bt corn is beneficial is less clear. Bt corn controls the European corn borer, a pest that destroys corn on a sporadic and unpredictable basis. That insect reaches levels where it causes significant financial loses to farmers only once every four or five years and in most cases farmers do not spray pesticides to prevent those loses. Thus, farmers may buy Bt corn seeds in a season when pest pressure is minimal and the additional seed cost for the Bt corn seed is not economically justified. Thus, Bt corn has probably provided modest economic gains and relatively small reductions in pesticide use. It does reduce insect damage and increases yields in years when a large number of pest are present.

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13. What are the main health concerns related to GE crops?

Potential harm from GE crops include the production of new allergens or toxins, or unexpectedly increased levels of naturally occurring toxicants or allergens found in crops. Such unexpected changes may be caused by disruption of native genes, unexpected interactions between the GE genes and plant components, or due to the GE process itself. A more remote possibility is that new harmful substances could be produced by the plant.

It is important to understand that all of those categories of unexpected changes can occur through traditional forms of plant breeding that have been carried out for many decades. In fact, the only known cases of increased or new harmful compounds have been due to traditional breeding methods, not genetic engineering. Nonetheless, it is clear that many genes that have never been in the food supply, and that could not be introduced by traditional means, can be introduced by genetic engineering. Uncertainties about the properties of new genes and uncertain interactions with the native genes of the plant warrant a cautious approach to the regulation of GE plants.

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14. Can GE foods cause new allergies?

Allergies are typically caused by proteins, and since most engineered crops produce new proteins, it is possible that new allergens could be added to a GE plant. In fact, several years ago an allergen was inadvertently transferred from the Brazil nut to a genetically engineered variety of soybeans. That allergen was detected by safety tests and the GE soybeans were never commercialized.

No conclusive tests currently exist to predict whether a GE protein that has never been in the food supply, as is the case with many engineered crops, will cause allergic reactions. Instead, several tests are used that together provide some confidence that the new protein will not be an allergen. Those tests have been conducted for the already commercialized products, but often not with the best test procedures (for more on the inadequacies of the current safety testing at FDA see Plugging Holes in the Biotech Safety Net.

It is also important to keep in mind that while we consume tens of thousands of different proteins, most serious food allergies are caused by only a handful of them, such as a few proteins from peanuts, milk, or tree nuts. Therefore, the likelihood that any particular protein will be an allergen is small. On the other hand, we should be assured that even the small chance of a new allergen introduced to the food supply is avoided before marketing a GE food, since foods allergies can cause death in some cases and significant discomfort in others.

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15. What was Starlink corn and was it allergenic?

Starlink was a variety of Bt corn intended to kill certain insect pests. Starlink contained a different Bt gene than other Bt corn varieties and microbial Bt sprays used by conventional and organic farmers. The Bt protein produced by Starlink corn did not pass the allergenicity testing required by EPA, so EPA considered it to be a potential allergen. Based on those test results, EPA decided in 1998 that Starlink corn could be used only for animal feed, not human food. The company that produced Starlink corn assured EPA that it would keep it out of the food supply, but testing by an environmental organization discovered that Starlink corn had gotten into corn food products, such as taco shells. Those test results led to numerous recalls of food products and an agreement to segregate all remaining Starlink corn so that it was only used only for animal feed.

Subsequent meetings of allergy experts convened by the EPA determined that there was a moderate chance that the Starlink protein could be an allergen. But because such a small amount of Starlink entered the food supply, those experts determined that there was a low probability that anyone would actually develop allergies to Starlink (Starlink made up less than 1% of the corn crop). Nevertheless, several dozen people contacted government agencies complaining of reactions to Starlink that resembled an allergy. Subsequent testing by FDA and the Centers for Disease Control determined that those reactions were not to the Starlink protein, but the experts were not entirely satisfied that the tests were completely reliable.

Starlink is no longer grown, even for animal feed use. The company that produced Starlink paid millions of dollars to remove Starlink from the food supply. A lesson from the Starlink episode is that it is difficult to segregate different varieties of commodity crops like corn, soybeans, or wheat from each other in the current grain-handling system.

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16. What are the major environmental risks from the growing of GE crops?

GE crops might harm the environment in several ways. One way is for the crop to produce substances that kill beneficial organisms above or below ground. Those toxic effects would be limited primarily to the crop fields, but since crops are a major land use, the harm could be considerable. Initial evidence suggested that Monarch butterflies might be harmed by certain Bt corn varieties, but additional and more extensive experiments showed that harm to be unlikely.

Another way GE crops could harm the environment is if they grow where they are not wanted. While most cultivated crops do not survive beyond well-tended fields, seeds from one year's crop that are not harvested may grow the following year, when a different crop may be planted. Those "volunteer" plants may be undesirable in the new crop. If the "volunteer" is an herbicide-resistant variety, there may be fewer or less desirable choices to control it. That has occurred with some herbicide-resistant canola in Canada, where control options have been reduced in some cases.

Mating between crops and their wild relatives (some of which may be serious weeds) also might harm the environment. Many crops have sexually compatible wild relatives, often in the regions where the crop originated. In the U.S., corn and soybeans do not have wild relatives, but squash, canola and wheat do. The transgenic genes for herbicide-resistance, for instance, could be transferred to the wild relative by pollination from the GE crop. If the new gene does not harm the wild relative, it might persist and spread. Unlike the crop, it is almost impossible to eradicate a widely dispersed wild relative containing a new gene. Crop genes in wild relatives are not necessarily harmful, but could cause harm if they make those wild relatives hardier and those plants spread at the expense of other species. Indeed, in several cases, natural crop genes have enhanced the weediness of important weeds. In a recent GE example, preliminary experiments show that a Bt gene may enhance the survival of wild sunflowers. Conversely, agricultural genes may weaken wild relatives and cause the demise of limited populations of those plants. That is especially a concern in centers of origin for the crop, where wild relatives are important sources of biodiversity, supplying traits like disease resistance or stress tolerance to crop breeders. Several wild relatives of crop plants were driven to extinction due to gene flow from conventional crop varieties.

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17. What was the controversy about GE corn and Monarch butterflies?

An experiment performed at Cornell University showed that large amounts of pollen from Bt corn applied to milkweed leaves, the natural food of Monarch butterfly larvae, could kill larvae feeding on those leaves. That result suggested that Monarchs might be killed in the environment by consuming pollen from Bt corn plants. EPA had not thoroughly considered that possibility when it approved Bt corn.

Subsequent research sponsored by EPA and USDA in several parts of the U.S. and Canada determined that the pollen from about 95% of the Bt corn varieties does not contain enough Bt toxin to significantly harm Monarch larvae. Furthermore, corn sheds pollen for only about two weeks, and for much of the country (except the northern parts of the corn belt) Monarch larvae are not often present when pollen is found on the milkweed leaves. Some questions about possible subtle effects remain unanswered, but it is unlikely that continuing experiments will find significant harm.

While some have contended that the lack of substantial harm to Monarchs in the environment showed that EPA had done an adequate job before approving Bt corn, in reality a substantial amount of luck was involved. In particular, the pollen of one type of Bt corn, grown on about 5% of Bt corn acres, contains enough Bt toxin to kill Monarch larvae in the amounts often found on milkweed leaves in corn fields. However, that corn variety is no longer grown. Had that variety been as widely grown as others, Monarchs might have been harmed. It was a matter of farmer preference for the other Bt varieties, rather than thorough risk assessment, that prevented that harm from occurring.

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18. What was the controversy concerning GE corn in Mexico?

In 2000, two scientists published experimental results that indicated the presence of GE genes in native corn in rural Mexico. It is illegal to grow Bt corn in Mexico, so the results suggested there might be a potential legal problem. Mexico has outlawed GE corn because it is the center of origin for corn and many diverse corn varieties are found there. Many scientists are concerned that GE genes might get into native varieties of corn and reduce that biodiversity.

Subsequent tests by scientists to verify the GE gene in Mexican corn were found to be inconclusive. In addition, some of the more controversial results, especially concerning the possible rearrangement of the GE genes, were found to be inadequately supported or incorrect. Further tests are being conducted to determine whether the original results about the presence of GE genes in Mexican corn are correct. Regardless of the those results, many scientists believe that GE corn will eventually integrate into native Mexican varieties if it is not already there, because some Mexico farmers would see the advantages growing insect-resistant corn. Similarly, it is also inevitable that genes from ordinary hybrid corn will get into Mexican corn varieties as farmers plant them.

The most important issue raised by the controversy has been so far unanswered. What harm, if any, will result from the presence of a transgene in a native Mexican corn variety? Some scientists that study the effects of "geneflow" between species are doubtful that Bt genes would have deleterious effects on local Mexican corn or wild relatives. However protecting biodiversity is extremely important. Thus, biodiversity should be protected and a cautious approach should be taken regarding GE and conventional hybrid corn in Mexico.

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Future Agricultural Applications of Biotechnology

19. What new GE crops are being developed?

GE crops commercialized in the next one to three years are likely to be versions of herbicide-resistant and Bt-insect resistant crops. New for the 2003 growing season is a variety of Bt corn that controls corn rootworms. More insecticide is used to control corn rootworm than for other corn insect pest in the U.S. Those broad-spectrum insecticides could be substantially replaced if the new Bt corn is widely adopted and if it performs as the developer predicts. However, EPA did not follow a panel of expert scientists' recommendations on measures to prevent insect resistance and preserve the use of that crop. Instead EPA followed the weaker recommendation of the developer. The experts were also not satisfied with all of the environmental safety studies performed by the company, and EPA required further tests to be carried out over the three years of the temporary registration.

Herbicide-tolerant (Roundup Ready) wheat is also in the pipeline for review and approval by U.S. and foreign regulatory agencies. There has been considerable concern about the introduction of RR wheat among U.S. and Canadian farmers and millers who are worried that they could lose important export markets, because GE wheat may not be accepted by Europe, Japan and other countries to which wheat is exported. As with other grains, different sources of wheat are mixed after harvest, so the introduction of GE wheat might eliminate or greatly reduce all wheat exports. Several environmental issues with the introduction of RR wheat also remain unanswered. Regulatory review of RR wheat has not been completed by USDA.

GE crops with direct consumer benefits, such as enhanced nutritional properties, are probably at least three to five years from commercialization. Rice engineered with more beta carotene (vitamin A) enhanced rice, so-called "golden rice," is being developed for developing countries but is not intended for U.S. consumption. A recent GE tomato variety with antioxidant lycopene levels about four times higher than conventional tomatoes was reported from a research laboratory in 2002. Those and other GE research crops show that these "second generation" GE crops are feasible. Research continues in numerous crops, including potato, cassava, sweet potatoes, apples, and so forth.

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20. Will plants be engineered to produce pharmaceuticals and industrial chemicals?

No pharmaceuticals are being produced commercially in crops, but many field-trials of such crops are occurring. The most common crop used for those field trials is corn. That is risky if not done carefully because pollen from corn engineered to produce a pharmaceutical ("pharm" crops) could contaminate food corn in neighboring fields by pollinating it. While regulatory requirements for minimum distances between "pharm" and food corn are designed to keep levels of cross-fertilization low, many pharmaceuticals affect the body at tiny concentrations. The current law does not require the developer to assess the potential harm caused by pharmaceuticals produced in plants if they enter the food supply. Recently, USDA strengthened its regulatory requirements to keep "pharm" crops out of food, but those provisions do not guarantee complete isolation.

Until August, 2003, plants engineered to produce industrial chemicals received even less regulatory oversight than pharmaceutical crops. Those plants could be grown under USDA's notification procedures instead of the more stringent permit process used for plants engineered with pharmaceuticals. For example, the protein avidin was produced commercially in corn under a notification to USDA rather than a permit. Recently USDA amended its regulations to require that plants engineered to make industrial compounds receive a USDA permit before they can be grown in the field. USDA has also stated that those permits will be subject to confinement conditions similar to those put in place for pharmaceutical plants.

Viable alternatives to growing pharmaceuticals or industrial chemicals in food crops exist. For example, non-food crops like tobacco can often be used. Other methods involving fermentation of engineered bacteria in tanks (rather than planting crops in fields) hold promise as alternatives to using food crops to produce such substances. Even with alternatives like tobacco, however, regulation must be improved. For example, currently, infectious GE plant viruses are being used experimentally to produce pharmaceuticals in tobacco. Some versions of those viruses can infect some food crops.

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21. Will there be GE animals in the future?

Numerous researchers around the world are developing genetically engineered animals. Animals, such as livestock, fish or insects, may be genetically engineered in a manner similar to GE plants. So far, no GE livestock is in commercial use. For example, Dolly the sheep was not genetically engineered, but was cloned (that is, a nearly identical animal was produced from the cells of an adult sheep, rather than the addition of new genes). Genetically engineered animals used for research, such as mice, have been commercially available for several years.

When GE animals are commercialized, they will present many of the same risk issues as GE plants, as well as ethical concerns about the welfare of the animals. The most likely first application for a commercial GE animal will be a salmon engineered to grow faster. A Massachusetts company, Aqua Bounty Farms, has genetically engineered Atlantic salmon to grow twice as fast by inserting into it genes from two other fish species. The fish reaches full size in just 18 months instead of the usual 36 months. Under the current regulatory system, FDA will review the GE salmon for both food and environmental safety before it is commercialized. Many scientists believe that such an application will raise significant environmental risks, since salmon are not highly domesticated and the GE salmon would likely survive in the wild. Aqua Bounty will use only sterilized female fish to minimize risks of interbreeding with non-engineered salmon. Furthermore, the FDA may not have adequate legal authority and scientific expertise to assess the environmental impacts of GE animals.

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