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Biotechnology: Regulations May Help Consumer AcceptanceBiotechnology: Regulations May Help Consumer Acceptance

May 1, 1996

12 Min Read
Biotechnology: Regulations  May Help Consumer Acceptance

Biotechnology: Regulations
May Help Consumer Acceptance
May 1996 -- Perspectives

By: Andrea Horwich Allen
Associate Editor

  Nowhere in the scientific arena is the gulf between the consumer press and the technical media more apparent than in the burgeoning field of biotechnology. But the conflicting interpretations of a report in the March 13 New England Journal of Medicine made that gulf look like an ocean.  Even newspapers widely known for their balanced reporting and detailed coverage jumped into the fray on March 14. The New York Times report carried the headline, "Study warns of dangerous effects of tinkering with food crops." The Wall Street Journal stated, "Another shadow was cast over the agricultural biotechnology industry..."  This same NEJM study was hailed by organizations as diverse as the International Food Information Council (IFIC), a nonprofit industry group that provides science-based information on food safety and nutrition; the Food Allergy Network, a nonprofit group that helps people deal with food allergies; and the Institute of Food Technologists, a nonprofit scientific society for food science and technology.  Their assessment: Yes, the study showed that allergens can be transferred from one plant to another through genetic engineering, as The Wall Street Journal noted. More to the point, it also showed that safeguards are in place to identify these allergens and prevent them from being transferred. That's exactly what the study was designed to show -- and exactly what the consumer media missed, according to Joyce Nettleton, D.Sc., IFT's director of science communications.  What was this study, which generated such diverse reactions? It was an experiment conducted by University of Nebraska researchers involving soybeans that were genetically enhanced with proteins from Brazil nuts. Pioneer Hi-Bred International, Des Moines, IA, had developed the soybeans with the amino acid methionine, which the company took from Brazil nuts. The company had planned to use the enhanced soybeans as animal feed, enabling farmers to cut back on their use of livestock supplements.  The researchers confirmed that the protein had been transferred from the Brazil nuts to the soybeans, and that the protein was allergenic. Pioneer elected not to market the genetically enhanced soybeans, citing the difficulties involved with ensuring that they would not find their way into human food.  An important aspect of this study that was all but overlooked by the mass media was that the researchers were doing more than testing for allergens in the genetically enhanced soybeans. They were also testing methodology for assessing the presence of allergens in foods.  "The purpose of the study was not to see if you could transfer an allergenic protein," Nettleton says, "but to see whether the allergenic property would be retained if the protein were somehow modified in the transfer."  The testing procedure, which was two years in the making, had been reviewed by regulatory agencies in the United States and abroad, "and represents scientific consensus on the best way to assess the potential transfer of food allergens in foods produced through biotechnology," according to an IFIC spokeswoman.  "The process works," said Anne Munoz-Furlong, president of the Food Allergy Network. "The Brazil nut study is an ideal example that shows that this very important aspect of food safety is being addressed."  Besides, had Pioneer elected to market the genetically enhanced soybeans regardless, regulations are already in place that would have required them to be labeled as potential allergens. This point was made in some of the newspaper accounts, but it trailed the dramatic headlines.  Specifically, the U.S. Food and Drug Administration has been dealing with genetically engineered foods in accordance with a policy statement published in May 1992. The policy, which is based on existing food-additive law, "treats substances intentionally added to food through genetic engineering as food additives if they are significantly different in structure, function, or amount than substances currently found in food," according to FDA's backgrounder on biotechnology.  In other words, the agency requires pre-market approval for food additives that are developed through biotechnology, as well as those that aren't. If a bioengineered food crop does not contain substances that are significantly different from the current food supply, then it does not require pre-market approval.  Consumer groups that are pressing for mandatory labeling of bioengineered foods have been playing the allergen card for several years, starting long before the University of Nebraska researchers published their findings.  FDA's policy does require that if a gene is transferred from a crop that's known to be a food allergen, the modified food must be labeled accordingly -- unless the manufacturer can show that the allergen has not been transferred. In the case of the genetically modified soybeans, they would have had to carry a warning along the lines of, "Contains Brazil nut protein."  Even if the protein being modified or transferred is not a known allergen, and the vast majority of proteins are not, FDA officials also ask manufacturers to consider whether their proteins have allergenic characteristics. Known allergens have certain common traits, including resistance to heat and digestion, according to Laura Tarantino, Ph.D., chief of the Biotechnology Policy Branch in FDA's Office of Premarket Approval. A protein that shares those characteristics might also trigger labeling, even if it were not a known allergen.  Tarantino acknowledges that the agency has been "concerned" with the possibility of allergen transfer. But so far, she says, the additive approval process and the biotechnology policy have adequately addressed the issue.The way FDA determines whether the genetic modification constitutes a food additive is through "consultations" between the manufacturer and the agency. FDA officials prefer this term to "pre-market notification," as the process is often called within the food industry.  Semantics aside, manufacturers usually find themselves engaged in extensive dialogue not only with FDA, but also with the U.S. Department of Agriculture and the U.S. Environmental Protection Agency. And, as is the case with conventionally derived substances, approval from or deregulation by all three of these agencies applies only to the specific construction of the protein and to the specific application.  Whereas FDA is concerned with human toxicity, USDA's role is to determine whether a substance -- in this case, a bioengineered crop -- constitutes a plant pest. "Our concern is whether the engineered plant retains or transfers a bad characteristic that can spread to other crops and damage the environment," notes Arnold Foudin, Ph.D., deputy director of biotechnology, biologics and environmental protection at USDA's Animal and Plant Health Inspection Service.  If the substance is not determined to be a plant pest, APHIS will respond to the manufacturer's petition by deregulating, or delisting, the substance.  If the substance is being introduced into the plant for pesticidal purposes, the manufacturer also must consult with EPA's Office of Prevention, Pesticides and Toxic Substances. Under the terms of the Federal Food, Drug and Cosmetic Act, EPA must register a food tolerance for a substance that confers pest resistance -- again, whether or not the substance is bioengineered.  EPA has registered five tolerances -- for Bacillus thuringiensis in corn, cotton and potatoes, as well as for two viral coat proteins in squash. Elizabeth Milewski, Ph.D., special assistant for biotechnology, says the EPA has yet to receive a petition for a substance that did not qualify for an exemption.  Until this past February, USDA's biotechnology-related activities were handled by the Office of Agricultural Biotechnology. OAB, which was established in the mid-1980s, coordinated the efforts of APHIS and the Food Safety and Inspection Service, which deals with animal health, as well as their interaction with EPA and FDA.  The absence of legislation to regulate biotechnology necessitated an office like OAB to help coordinate policy, Foudin notes. The closing of the office reflects the high degree of cooperation and coordination among the agencies, and the fact that policies are in place to handle biotechnology issues, he maintains.  Foudin disputes the claims by some groups that legislation is needed to regulate biotechnology. "In hindsight, Congress did the perfect thing in not hanging this albatross around its neck," he says.  Although Foudin acknowledges that bioengineering "challenges the sociological and religious convictions" of some consumers, he says the answer lies not in regulations but in voluntary labeling, similar to the organic certification framework that USDA is now developing.  Another frequent criticism of biotechnology is that regardless of EPA and USDA safeguards, it will ultimately damage the environment because pests and viruses will eventually adapt and become increasingly virulent. To this point, the industry has initiated its own safeguards.  Monsanto Co., for one, urges farmers to institute a "resistance management" program, according to spokesperson Karen Marshall. For example, to determine whether insects could become resistant to Bacillus thuringiensis -- and to prevent that from happening -- the company works with growers to take measures that might include planting a certain percentage of crops that have not been modified with the gene. For some crops, such as cotton, a resistance management program is mandatory.  Nor is biotechnology the bane of consumers with food allergies. Not only are adequate labeling regulations in place to protect those consumers, Foudin says, but the technology itself ultimately will be their best defense. "Biotechnology allows allergists to identify the gene that produces the specific (allergenic) protein," he explains.  "Traditional plant breeding does not have anything like the safeguards (of genetic engineering) built-in," adds Nettleton, of IFT. Traditional methods of hybridization, she notes, permit undesirable characteristics to be moved along with the desirable ones.  "There were no shortcuts, until molecular biology," Nettleton says. And yet, despite centuries of plant breeding, "people are not dying in the streets."Biotechnology in Practice: A Status Report  The public debate over biotechnology seems to have cooled since the late 1980s and early l990s, when the Flavr Savr tomato and recombinant bovine somatotropin were such scorching topics. Ironically, though, the rate of approvals for bioengineered crops has been picking up steam.  Monsanto Co., which first made headlines in the biotechnology arena with its Posilac rBST, has gained five approvals in the past year -- with considerably less controversy.Roundup Ready soybeans will enable growers to use this environmentally friendly, broad spectrum herbicide on crops. Roundup works by preventing plants from forming essential amino acids -- in essence, forming a roadblock. Soybeans with the Roundup Ready gene will have a built-in detour around that roadblock.Roundup Ready canola is now in limited launch in Canada.Roundup Ready cotton has been approved, but Monsanto will be delaying a widespread commercial launch until next year.Bollgard cotton, which protects itself against bollworms without the use of pesticides, is being launched commercially this year.NewLeaf potatoes are resistant to the Colorado potato beetle.A delayed-ripening tomato has been approved, but Monsanto is not commercializing it this year.Other agendas  Calgene, which developed the Flavr Savr tomato, has planned an extensive agenda of bioengineered crops reaching well into the next couple of decades. Monsanto has just purchased an equity interest in Calgene; while that was pending, the company gained some additional approvals, including:Laurate canola oil, a triglyceride that offers the functional advantages of tropical oils at a lower cost, acts primarily as a cocoa butter replacer. Calgene is marketing a non-edible version, as well, for use in cleaning products such as soaps and detergents. Scheduled for commercialization in the next few years: stearate canola oil, which will use antisense gene constructs instead of hydrogenation to increase the saturated fatty acid content of products such as margarines. The result should be a reduction of bans fatty acids in the food supply.BXN cotton, which is resistant to the herbicide bromoxynil, enables growers to use that product instead of other herbicides that are more expensive and must be used in greater quantities. Growers can cut costs, as well as chemical use.Also in the wings  Other companies have gained approvals for crops that are certain to improve the bottom line for growers, processors, or both. Products now on the market include:Freedom II squash seed, developed by Asgrow Seed Co., has been available since last fall. Through the use of viral coat proteins, this yellow crookneck squash resists two viruses: the zucchini yellows mosaic virus and the watermelon mosaic virus II. The company is using the same technology to guard against other viruses, and is engaged in other research that will improve the shelf life of crops such as cantaloupe, cucumbers and tomatoes.A low PG modified processing tomato, developed by Zeneca Plant Science, slows the action of the polygalacturonase enzyme. This enzyme breaks down the pectin in the cell wall of the tomato, causing the fruit to soften. Because more of the pectin is retained, the tomato holds up longer in the field and survives harvesting in better shape. It affords numerous benefits to processors, including improved viscosity, flavor and color, as well as energy savings during processing.  Zeneca is having a co-packer manufacture tomato paste, which is being sold in two British grocery chains: Safeway and Sainsbury. It is planning to launch the tomato domestically later this year. The company is also working with fresh tomatoes, bananas, potatoes and more.Improvements from academia  These kinds of improvements, whether or not they're bioengineered, are of growing interest to U.S. food designers. At Texas A&M's highly regarded Vegetable Improvement Center, private partnerships with food companies are an increasingly important source of funding. Seed companies and growers account for most of the funding, but according to the center's director, Leonard Pike, Ph.D., the greatest growth has been in the processing segment.  Pike, who is best known for developing the wildly popular Texas 1015 onion, reports that his team is using biotechnology mostly to identify genetic markers that reveal whether traits have been transferred through traditional breeding methods. While this can dramatically speed up the process, it doesn't replace traditional breeding.  The center has been working on a few bioengineered projects with its industry partners. For instance, working with University of Florida researchers and Monsanto's Gargiulo Produce Co. (now a unit of Calgene), the center has cloned the Never-ripe gene, which blocks the ripening process. Monsanto has since gained approval for use of the gene in tomatoes, but does not plan to commercialize them this year.  Biotechnology is often cited as an important weapon against the ravages of overpopulation and environmental destruction. Indeed, the potential for higher yields and a reduction in the use of pesticides and herbicides lends credence to that claim.  "This is an answer to how to feed more people, without putting more land into production," says Monsanto spokesperson Karen Marshall.  In the short term, though, it seems that benefits will accrue slowly but steadily for farmers, food designers and, ultimately, consumers, as bioengineering becomes more widespread.
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