Council for Biotechnology Information
August 12, 2007
All biotech crops grown in North America must go through years of rigorous testing before they are brought to market.
Before they ever reach a farmer's field or a family's dinner table, biotech crops undergo years of rigorous testing to ensure that they are safe for people, animals and the environment.
In fact, biotech varieties in North America are tested more thoroughly than conventional crops.1 One type of biotech soybean alone was subjected to 1,800 separate analyses before it reached farmers's fields on a commercial scale.2
A variety of scientific organizations — ranging from the National Academy of Sciences in the United States to the Royal Society in the United Kingdom3 — have recognized the safety of food developed with biotechnology for both the environment and to eat.
"Crops produced through biotechnology have proven to be as safe as or safer than crops produced by conventional breeding," wrote University of Illinois professor Bruce Chassy, an expert on the regulation of biotech crops and foods.4
In Canada and the United States, biotech products are regulated under the same framework that is used to determine the safety of their conventionally bred counterparts. The underlying principle at work is that approvals should be based on the characteristics of the end products rather than the process by which they are made.
And because biotech crops now on the market have been found to be "substantially equivalent" to their conventional counterparts and pose no greater risks, Canada and the United States do not require special labeling. If a biotech crop or food were different – such as having additional nutritional qualities – then labels would be required.
It can take more than a decade for the testing and regulatory process to be completed in the United States.
"From the first steps of discovery to final regulatory approval and product launch, the research and development process for a new genetically modified plant variety can take as long as from six to 12 years and can cost from $50 million to $300 million," said a February 2003 report titled, "Agricultural Biotechnology at the Crossroads," by Bio Economic Research Associates. "For each gene or trait explored in the discovery phase, the odds are roughly 1 in 250 that the gene or trait will make it into a commercial product."5
Thorough review process
In the United States, the safety of biotech food is overseen by three separate agencies.
- The Food and Drug Administration (FDA) assesses the safety of all biotech plant products intended for consumption by humans and animals.6
- The Department of Agriculture (USDA), through its Animal and Plant Health Inspection Service (APHIS), oversees field testing of biotech seeds and plants to make sure their release causes no harm to agriculture and the environment.
- The Environmental Protection Agency (EPA) evaluates biotech plants' environmental safety — such as their pesticide properties, possible effect on wildlife and how these plants break down in the environment. The agency also must approve any herbicide use with herbicide-tolerant crops.7
In Canada, there are six steps that must be taken before foods developed with biotechnology can be approved.8 Three agencies oversee the regulation of biotech products.
- Canadian Food Inspection Agency
- Health Canada
- Environment Canada
In Mexico, CIBIOGEM, which includes six national ministries (including Agriculture, Food and the Environment), and the Mexican Council of Science and Technology, regulate biotech food and crops.
In all three countries, many products come under review by more than one agency. Bt corn, for example, which is enhanced to produce its own naturally occurring protein to ward off insect pests, could be reviewed by the USDA to ensure it's safe to grow, by the EPA to confirm it's safe for the environment and by the FDA to make sure it's safe to eat.9
Academics, third-party scientists, consumers, growers and the public at large all have multiple opportunities to participate in the review process.
If the research is promising, the developer can apply to APHIS to conduct limited field tests of a genetically engineered plant. APHIS' role is to ensure that these enhanced crops pose no unwanted effects on agricultural health or the environment.10 Companies must submit detailed applications explaining what plant variety will be tested, how the test will be conducted and what steps will be taken to confine the tests to ensure that pollen and plants will not escape into the environment.11
Government regulators supervise critical steps in the process, such as the transport of seeds to and from trial sites.12 To bolster this regulatory oversight, APHIS created a new office — Biotechnology Regulatory Services — in June 2002 to better coordinate its scientific and regulatory expertise in the biotechnology arena.13 And it is expanding its oversight capabilities. Where 305 field test inspections were conducted in 2002, APHIS expects to conduct twice that number in the 2003 growing season, according to David Hegwood, a special counsel for the USDA.14
The U.S. EPA becomes involved in the regulatory oversight of biotech crops when they are modified to reduce insect damage15 — Bt corn or cotton, for example. The EPA conducts thorough safety assessments to determine what effects, if any, such enhanced crops could have on the environment, wildlife and nontarget insects, and to design strategies to reduce the likelihood insects could become resistant to these new crops.
"For example, during the review of the Bt potato, a test of potential effects of the introduced protein to lady beetles was conducted and showed that there were no adverse effects to these predators of the pesky Colorado potato beetles," said EPA Assistant Administrator Stephen Johnson in testimony before a U.S. House Agriculture subcommittee June 17, 2003. "For Bt corn, tests were conducted on the potential effects on fish because field corn may be manufactured into commercial fish food. No effects were observed in the tests."16
Following an incident in the fall of 2000 when traces of a type of Bt corn (StarLink), which was approved for use as animal feed but not for human consumption, was found in taco shells, the EPA changed its procedure to assure such a mishap does not occur again. The EPA now does not grant separate approval for a crop to be used in animal feed when the crop can also be used for human consumption.17
The FDA enters the regulatory picture when a biotech plant is to be used in food. "Bioengineered foods and food ingredients must adhere to the same standards of safety under the Food, Drug and Cosmetic Act that apply to conventionally bred counterparts," said FDA Deputy Commissioner Lester Crawford in testimony before a U.S. House Agriculture subcommittee June 17, 2003. "This means that these products must be as safe as the traditional foods in the market."18
Since the approval of the FlavrSavr tomato in 1994, every developer of biotech foods has, without exception, consulted with the FDA on a voluntary basis to preemptively address any safety or nutrition concerns before the product reaches the marketplace.19 In 2001, responding to the public's desire for a more formal, transparent process, the FDA proposed new guidelines that will make consultation mandatory.
"The agency is in the process of evaluating the more than 100,000 comments received," said Crawford. "The proposal has raised policy and legal concerns and is not a pressing public health priority for FDA, given that there is a voluntary consultation process in place that is working well."20
The FDA has also begun posting biotech food information supplied by manufacturers on its Web site.21
In Canada, a report that resulted from a two-year study by the Canadian Biotechnology Advisory Committee said that although the regulatory process could be improved, biotech foods currently on the market are safe.
"GM foods currently in the marketplace have arguably undergone greater regulatory scrutiny than their conventional counterparts," the report said.22 "We conclude that no scientific evidence exists to suggest that GM plants and foods currently in the market pose any greater health or environmental risk than other foods."23
Ongoing assessments
Review doesn't stop once products finally reach farm fields and dinner plates. Post-approval monitoring by the product developer, independent researchers and government scientists helps ensure that biotech crops continue to be safe for consumers and the environment.
In 2002, for example, the EPA re-approved Bt cotton and Bt corn after carefully reviewing concerns about potential insect resistance to Bt products and their effect on monarch butterflies.
Testing for allergies
Careful testing and regulation have ensured that biotech foods are safe, and there has never been a single documented biotech-related health problem for consumers.
Researchers have examined many of the health and safety concerns that have been raised about biotech foods — such as the possibility, for example, that consuming modified foods could lead to allergic reactions.
Professor Steve Taylor of the University of Nebraska, a leading allergy expert, says that evaluating food for its allergenic potential is a key part of the R&D and regulatory process. He said that 90 percent of food allergies are caused by a handful of known allergens that can be easily identified and avoided when biotech crops and foods are developed.
Taylor also believes that biotechnology is a promising tool for removing allergens from foods, which would give many allergy-prone people a wider choice of safe foods to eat.16
Critics of biotechnology often point to a case in which a gene from the Brazil nut, which can cause allergies, was added to a soybean to increase its levels of methionine and improve its value as an animal feed.24 In fact, early in the development process tests for allergenicity were conducted and, when problems were detected, the product was scrapped.25
"[It] would be a significant loss to humanity if the many benefits of biotechnology were not realized because of concerns that have little basis in scientific fact," says Brian Larkins, president of the American Society of Plant Physiologists and professor of plant science at the University of Arizona.18
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1 "Foods from Genetically Improved Crops in Africa," a brochure produced by the San Diego Center for Molecular Agriculture and AfricaBio.
2 Trewavas, Anthony, University of Edinburgh Biologist, December 20, 1999.
3 "Position Statements on Biotechnology: Royal Society of London, International Service for the Acquisition of Agri-biotech Applications, <www.isaaa.org>
4 Chassy, Bruce. "Food Safety Evaluation of Crops Produced Through Biotechnology," Journal of the American College of Nutrition, Vol. 21, No. 90003, 166S-173S (2002), <www.jacn.org/cgi/content/full/21/suppl_3/166S>
5 "Agricultural Biotechnology at the Crossroads," Bio Economic Research Associates, February 2003, p. 16, <www.bio-era.net>.
6 "Statement by Lester M. Crawford, Deputy Commissioner, Food and Drug Administration, Before the House Agriculture Subcommittee on Conservation, Credit, Rural Development and Research," June 17, 2003, p. 1, <http://agriculture.house.gov/hearings/1089.pdf>.
7 "Food Safety — Regulating Plant Agricultural Biotechnology in the U.S.," U.S. Department of State, August 9, 2000.
8 "Plant Biotechnology in Canada," Council for Biotechnology Information, </html/html/pdf/plant_bt_in_canada.pdf>.
9 "Regulatory Oversight in Biotechnology," United States Department of Agriculture.
10 "Testimony of David Hegwood, Special Counsel to USDA Secretary Ann Veneman, Before the House Agriculture Subcommittee on Conservation, Credit, Rural Development and Research," June 17, 2003, p. 1, <http://agriculture.house.gov/hearings/1089.pdf>.
11 "Testimony of David Hegwood, Special Counsel to USDA Secretary Ann Veneman, Before the House Agriculture Subcommittee on Conservation, Credit, Rural Development and Research," June 17, 2003, p. 2, <http://agriculture.house.gov/hearings/1089.pdf>.
12 "The U.S. Regulatory System," University of Nebraska Ag Biosafety Education Center.
13 "Testimony of Mr. David Hegwood, Special Counsel to Secretary Veneman, Before the House Agriculture Committee's Subcommittee on Conservation, Credit, Rural Development and Research," June 17, 2003, p. 5, <http://agriculture.house.gov/hearings/1089.pdf>.
14 "Testimony of Mr. David Hegwood, Special Counsel to Secretary Veneman, Before the House Agriculture Committee's Subcommittee on Conservation, Credit, Rural Development and Research," June 17, 2003, p. 5, <http://agriculture.house.gov/hearings/1089.pdf>.
15 "Testimony of Stephen L. Johnson, Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances, U.S. Environmental Protection Agency, Before the House Agriculture Committee's Subcommittee on Conservation, Credit, Rural Development and Research," June 17, 2003, p. 4, <http://agriculture.house.gov/hearings/1089.pdf>.
16 "Testimony of Stephen L. Johnson, Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances, U.S. Environmental Protection Agency, Before the House Agriculture Committee's Subcommittee on Conservation, Credit, Rural Development and Research," June 17, 2003, p. 7, <http://agriculture.house.gov/hearings/1089.pdf>.
17 "Testimony of Stephen L. Johnson, Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances, U.S. Environmental Protection Agency, Before the House Agriculture Committee's Subcommittee on Conservation, Credit, Rural Development and Research," June 17, 2003, p. 10, <http://agriculture.house.gov/hearings/1089.pdf>.
18 "Testimony of Lester M. Crawford, Deputy Commissioner, Food and Drug Administration, Before the House Agriculture Committee's Subcommittee on Conservation, Credit, Rural Development and Research," June 17, 2003, p. 6, <http://agriculture.house.gov/hearings/1089.pdf>.
19 "The U.S. Regulatory System," University of Nebraska Ag Biosafety Education Center.
20 "Testimony of Lester M. Crawford, Deputy Commissioner, Food and Drug Administration, Before the House Agriculture Committee's Subcommittee on Conservation, Credit, Rural Development and Research," June 17, 2003, p. 12, <http://agriculture.house.gov/hearings/1089.pdf>.
21 "FDA Announces Proposal and Draft Guidance for Food Developed Through Biotechnology," Food and Drug Administration press release, January 17, 2001, <www.fda.gov/bbs/topics/NEWS/2001/NEW00747.html>.
22 "Improving the Regulation of Genetically Modified Foods and Other Novel Foods in Canada," Canadian Biotechnology Advisory Committee, August 2002, p. ix, <http://publications.gc.ca/control/publicationInformation?searchAction=2&publicationId=116689>.
23 "Improving the Regulation of Genetically Modified Foods and Other Novel Foods in Canada," Canadian Biotechnology Advisory Committee, August 2002, p. xii, <www.cbac-cccb.ca/documents/en/cbac.report.pdf>.
24 "Genetically Modified Foods Undergo Strict Testing," Atlantic Restaurant News, Feb. 3, 2003, </html/Canada_Genetically_Modified_Foods.HTM>.
25 "Genetically Modified Foods Undergo Strict Testing," Atlantic Restaurant News, Feb. 3, 2003, </html/Canada_Genetically_Modified_Foods.HTM>.
Source: Council for Biotechnology Information.