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Letter from Prof. John Fagan to Richard Broome

Dear Richard,

Glad to hear that you are making some progress on the GE issue in South Africa.

Please let me know it there is anything that I can do to support your efforts. for instance, I have written briefs to regulatory agencies in a number of countries at the request of the NLP.

In response to your questions regarding testing, it turns out that the test does not use a machine, but is something that is done in a biochemistry laboratory. We receive samples from all over the world and test them here in Fairfield. We are also setting up arrangements with one or two labs in Europe that will use the Genetic ID technology to test in Europe. If there is a lab in SA that would be interested in setting up such agreement, we could do the same there. At present we have developed testing capabilities for soy, corn, and most processed products derived from these two commodities. We are developing tests for canola, potatoes and other foods, as well.

I am passing on your question to the people who are running the business side of Genetic ID. They will send you more written info on the test and company by email, or if you send your fax number we can send you information that way.

Again, it was great to hear from you, and I wish you great success in all the work you are doing for Maharishi.

Jai Guru Dev

John

PS I have attached the texts of a couple of recent articles that may be of interest.

Genetically Altered Food: Buyer Beware

by John Fagan
USA Today - March 6, 1997

There's a war on in Europe, and most Americans have hardly heard about it. It concerns the safety of something very basic to human life: our food. Why are we so uninformed while European consumers are up in arms and their governments are taking swift action against the uncontrolled introduction of genetically modified foods?

Mention genetically altered foods to most Americans, and you will get a blank stare. A genetically cloned sheep has stolen the headlines. Yet with each passing day, we are filling our grocery carts with these foods in ever-increasing percentages without our knowledge or consent.

In Europe, shiploads of these products have been halted at borders. Supermarket chains and food producers have banned these products from their shelves or promised consumers that they will label these foods conspicuously. In fact, several nations are enacting stringent labeling requirements.

What is at the core of the fear about these new foods? And should this concern derail work some claim will increase agricultural efficiency and reduce world hunger? Scientific journals and leading scientists have joined in the chorus to urge definitive research into the possible risks in advance of mass use by humans.

Scientists have altered foods by inserting into them genes from bacteria and viruses. Many more such products containing foreign DNA from insects, fish and even humans are in the R&D pipeline and soon will be headed for our dinner plates.

Foods altered through genetic engineering often contain proteins and other components that have never before been part of the human diet: proteins from bacteria and viruses and, in the future, proteins from insects, scorpions and people. There is no way to predict whether those foods are safe to eat. The only way to tell is to test them rigorously. Yet our government does not require such testing.

The risks are not hypothetical. Any unbiased scientist familiar with the technology will admit that genetic engineering can give rise to unanticipated allergens and toxins. Already we have seen this scenario in action. In 1989, a dietary supplement, L-tryptophan, caused 37 U.S. deaths and 1,511 nonfatal cases of a disease called eosinophilia-myalgia syndrome (EMS). The Centers for Disease Control linked these cases to tryptophan manufactured using genetically engineered bacteria. A study published in Science in 1990 confirmed that this tryptophan was contaminated with a toxic "novel amino acid" not present in tryptophan produced by other methods.

How could this problem have been prevented? Routine food-safety tests could not have done the job. They can only detect the presence of toxins or allergens known to be present in common foods such as shellfish and peanuts. Such tests on the genetically altered tryptophan would not have registered a blip. Only biological and clinical tests on humans would have revealed the truth. Unfortunately, these tests were not done. Moreover, they are still not required for other genetically engineered foods. Advocates maintain that the risk from any given genetically engineered food is small and argue, therefore, that it is unnecessary to carry out stringent safety testing.

This view is not scientifically responsible. Thousands of these food products will be brought to market over the next several years. When we do the math, the small risk that any given product will produce unanticipated effects translates into virtual certainty of harm when many new genetically engineered foods have become part of the diet of large populations over extended periods of time.

What is the solution? Given that millions of dollars have been invested in developing these products, we cannot exclude them from the market. Nonetheless, consumer safety must be protected. Here are three suggestions to address both issues.

Safety testing must be made more stringent. The only scientifically valid approach is to feed these foods to human volunteers and see how they respond. Such testing is required by the FDA before new foods or additives produced by other methods can be marketed. Why should genetically altered foods be an exception?

All genetically engineered foods must be labeled as such. Safety testing can never give us a guarantee with 100% certainty. For example, tests extending over three years may fail to detect harmful effects that require five years to emerge. Mandatory labeling gives the consumer choice in whether to accept that risk. Health officials can also better trace the source of any problems if the products are labeled.

The public must be properly informed about the benefits and risks. Informed choice by consumers will protect the integrity of the biotechnology and food industries and maintain the confidence of the American food supply

Dr. John B. Fagan is a molecular biologist who has conducted research using recombinant DNA techniques.

Biotechnology's Bounty

By MARIAN BURROS
THE NEW YORK TIMES May 21, 1997

Last December, Whole Foods Market, the largest natural foods supermarket chain in the country, sent letters to more than 400 of its suppliers, asking if their products contained genetically engingeered ingredients. About three-quarters of the suppliers have not yet responded.

"Most of them don't know about their ingredients and are scrambling to find out," said Margaret Wittenburg, quality assurance director of Whole Foods, who wrote the letter.

Most Americans are in the dark, too. They have no idea what foods on their supermarket shelves contain genetically engineered ingredients because the Government does not require those products to be labeled. A small but growing movement of people is pushing for that to change.

Genetically engineered food is created by taking the DNA from one organism and inserting it into another. The process passes on certain characteristics to plants and animals. The resulting organism is called "transgenic." This modification of gene material is not possible with traditional selective breeding.

No tests have been conducted to determine the impact of transgenic food on the human diet. At least one study published in the New England Journal of Medicine, however, has shown that some genetically engineered food has the potential to cause allergic reactions.

Producers are turning to genetic engineering for a more abundant, less expensive and more nutritious food supply. Biotechnology companies like Monsanto and Novartis produce genetically engineered soybeans, tomatoes, squash and corn. There has been talk, for instance, of inserting flounder genes in tomatoes to keep them from freezing.

More soybeans are genetically engineered than any other food, and 13 percent to 16 percent of the country's soybean crop is being grown from genetically engineered seeds. Between 60 and 70 percent of processed food contains soy, but there is no way to know, without testing, how much of that is genetically engineered. About 2 percent of the corn crop is genetically engineered.

Europeans have been quicker than Americans to react to transgenic food. Thousands of Europeans, rallied by Greenpeace and green parties, have participated in referendums and rallies, signed petitions and marched in protest to the corporate headquarters of biotechnology companies. They have demanded that transgenic food be labeled and kept separate from other food. The European Commission has proposed strict labeling. In Austria and Luxembourg, genetically engineered food is banned.

Most observers suggest that Europe's response is so much more intense because of the European experience with mad cow disease.

It's not that Americans are ignorant of genetic engineering --almost everyone is aware of Dolly, the sheep that was cloned. And many people have raised objections to milk from cows that have been given the genetically engineered bovine growth hormone to increase milk output. Americans also have strong opinions about the need for labeling.

In a survey announced this year by Novartis, 93 percent of respondents agreed that labeling is needed. At the same time, 21 percent said transgenic food is very safe, and 50 percent said it is somewhat safe.

So far, small groups of consumer advocates are raising health and environmental concerns about genetically engineered products. Those consumers pushed Whole Foods to get answers from their suppliers. The company wrote in its first letter to its suppliers that mandatory labeling "is the only way consumers can exercise their right to choose not to consume genetically engineered foods." It added, "Accordingly, Whole Foods Market is requiring verification from your company as to whether the single or multiple ingredients in your products are from genetically engineered sources."

In two months, the company heard from only a quarter of the suppliers. It wrote the others: "First we wanted you to understand the depth of passion that our customers have for accessing food from nongenetically engineered sources. Second, we wanted to be the impetus for manufacturers to pressure their suppliers for assurance of nongenetically engineered sources. Third, we wanted to see what the reality of the situation truly is at this time for manufacturers being able to access nongenetically engineered ingredients."

The company is also urging customers to write to the Food and Drug Administration demanding labeling. There are signs that the consumer movement is gaining momentum. Nebraska and Maine are considering legislation for labeling. Mothers for Natural Law, a nonprofit consumer advocacy group, has begun a public awareness campaign. The group, which is affiliated with the Natural Law Party, which promotes transcendental meditation, wants to collect a million signatures on a petition asking the Food and Drug Administration to require testing and labeling of transgenic foods.

In this country, transgenic food is not tightly regulated because the Food and Drug Administration says it is safe. Companies must get F.D.A. approval to market a genetically engineered product only if the food contains a known toxic substance, nutrients that are different from the original food, any new substances or a known food allergen, or if it uses antibiotic-resistant genes. Labeling is required only if a transgenic food carries a known food allergen. For those with unusual allergies, like one to bananas, there is no way to know what foods to avoid.

The problem of allergens was outlined in the New England Journal of Medicine for May 14, 1996. In a study at the University of Nebraska a gene from a Brazil nut was introduced into a soybean. The genetically modified soybean was tested on people known to be allergic to Brazil nuts, and they had an allergic reaction to the modified soybeans but not to the unmodified soybeans.

"Genetic engineeers are taking genes from bacteria, viruses and insects and adding them to fruits, grains and vegetables," said Dr. Rebecca Goldburg, an Environmental Defense Fund senior scientist. "They are producing foods that have never before been eaten by human beings. Consumers should not be guinea pigs for untested food substances."

Skip Rogland, the vice president of communications for Novartis in the United States, said that as long as the federal government approves the products, "consumer safety has been protected, and we've complied with the law." He added that the company supports "labeling of genetically engineered raw products when there is scientific evidence that requires it."

How prevalent is transgenic food? This column asked Genetic ID, a company in Fairfield, Iowa, that tests food for genetically engineered ingredients, to test four soy-based baby formulas and eight other products made with soy or corn. The formulas -- Carnation Alsoy, Similac Neocare, Isomil and Enfamil Prosobee -- all tested positive. Eden Soy milk tested negative. Morningstar Farms Breakfast Links and Morningstar Farms Better 'n Burgers, Betty Crocker Bac-os Bacon Bits, all soy-based products, also tested positive. And so did three corn-based chips -- Fritos, Tostitos Crispy Rounds and Doritos Nacho Cheesier.

Consumer advocates worry that treating infections could become more difficult because some genetic engineering introduces antibiotic-resistant genes into food. And critics have raised concerns about potential environmental problems, like the unintentional creation of weeds resistant to some herbicides and pests resistant to certain pesticides.

For now the only way Americans can avoid genetically engineered food is to choose certified organic food. But even that might change.

The Agriculture Department is expected to release national standards for organic foods this year, and there is concern among organic farmers and processors, consumer advocates and some scientists that the department will override the recommendations of the National Organic Standards Board, which voted to prohibit genetically engineered foods from being labeled organic.

Following is a list by Genetic ID of Fairfield, Iowa, of genetically engineered foods that have been approved by the federal government, that await approval or that are under development. An asterisk marks foods that are for sale.

© Copyright 1997 The New York Times Company

New England Journal of Medicine Vol. 334, Issue 11, 1996

Allergies to Transgenic Foods -- Questions of Policy

Food biotechnology, the use of recombinant-DNA and cell-fusion techniques to confer selected characteristics on plants and animals used for food,

1. can be used to increase agricultural productivity. The great promise of biotechnology is that the use of these techniques will help solve world food problems by creating a more abundant, more nutritious, and less expensive food supply. Despite this promise, public concern about the safety, usefulness, and social consequences of genetically engineered food products has led to boycotts, legislative bans, and demands for stronger federal regulation.
2. Such actions have caused leaders of the biotechnology industry to identify public "biotechnophobia" as the most serious threat to commercialization of their products and to view as their most critical challenge the need to reassure people that the new techniques are both safe and beneficial.
3. Questions of safety vex federal regulators and industry as well as the public. The transfer of genes from microbes, plants, or animals into foods raises issues about the unintended consequences of such manipulations. Allergenicity could be one such consequence. Genes encode proteins; proteins can be allergenic. Biotechnology companies might be introducing allergenic proteins from donor organisms into the food supply. The Food and Drug Administration (FDA) anticipated this problem in 1992 when it devised its policy on transgenic plant foods.
4. But because this policy requires premarketing notification of the FDA, premarketing safety testing, and labeling only of foods with genes transferred from the 8 to 10 most commonly allergenic foods, public-interest groups have cautioned that existing rules inadequately protect people against lesser-known transgenic allergens to which they might be sensitive.
5. n this issue of the Journal, Nordlee and her colleagues confirm that food allergens can indeed be transferred from one plant to another by transgenic manipulation ( in this case, from Brazil nuts to soybeans.
6. They identify 2S albumin as the principal allergen of the Brazil nut and demonstrate that people who react to Brazil-nut extracts on standard skin-prick tests have similar reactions in response to extracts of transgenic soybeans that contain 2S albumin. The authors also collected serum from people known to be allergic to Brazil nuts and analyzed the ability of proteins in transgenic soybeans to bind to IgE in the serum samples, using radioallergosorbent tests and sodium dodecyl sulfate-polyacrylamide-gel electrophoresis.
   Unique circumstances permitted this demonstration of transgenic allergenicity. Pioneer Hi-Bred International developed the transgenic soybeans used in this study in an attempt to increase the amount of sulfur-containing amino acids ( methionine and cysteine ( in soy-based animal feeds. Such feeds must otherwise be supplemented with methionine (which can be converted to cysteine) to promote optimal growth. The Brazil-nut 2S albumin is exceptionally rich in methionine and cysteine; its gene was a logical choice as a donor. Nuts are known to cause IgE-mediated hypersensitivity reactions that range from mild itching to sudden death.
   This study highlights gaps in our current knowledge of food allergies. Stored serum samples from people with specific food sensitivities are limited; in the absence of such samples, the demonstration of the allergenicity of a food is less compelling. Thus, although about one fourth of Americans believe that they or their children are allergic to specific foods, adverse reactions to the food are confirmed by testing of serum samples or the more precise double-blind challenge tests in no more than 2 percent of adults and 8 percent of children.
7. Many more people may have food sensitivities, however, especially since the prevalence of such conditions seems to be increasing as more proteins are added to commercially prepared foods.
8. Furthermore, most biotechnology companies use microorganisms rather than food plants as gene donors, even though the allergenic potential of these newly introduced microbial proteins is uncertain, unpredictable, and untestable. (4) Pioneer Hi-Bred developed its soybeans for use in animal feeds, but there is no easy method of separating soybeans destined for animals from those slated for human consumption. Soy proteins, which are less allergenic than milk proteins, are used in infant formulas, meat extenders, baked goods, and dairy substitutes. Because the consumption of soy-based foods appears to reduce the risks of heart disease and cancer,
9. the prevalence of soy proteins in foods consumed by infants and adults is sure to increase. From the standpoint of human nutrition, soybeans are just fine the way they are. Their methionine content is sufficient and not a problem; even if used as the sole source of dietary protein, soy foods maintain nitrogen balance and support growth in adults, children, and full-term infants and must be supplemented only in feeding premature infants.
10. The results of the study by Nordlee et al. (6) have important regulatory implications. The 1992 FDA policy on transgenic plant foods begins with the premise that the techniques used to create these products raise no new or unusual safety issues. (4) As is the case for other foods generally recognized as safe, the FDA has the authority to remove transgenic foods from the marketplace if unexpected problems arise. When transgenic foods contain genes transferred from donors that are commonly allergenic, the FDA considers them to be governed by food-additive regulations and requires premarketing notification, testing, and labeling. (4) Figure 1 shows the FDA protocol for gene transfers involving donors that are commonly allergenic. Under this policy, Pioneer Hi-Bred was required to – and did – consult the FDA about the need for premarketing safety testing. Given the results of the present study, the company would have had to label its transgenic soybeans. Instead, it discontinued plans to market them.

Because FDA requirements do not apply to foods that are rarely allergenic or to donor organisms of unknown allergenicity, the policy would appear to favor industry over consumer protection. In a discussion of 3300 public comments on the policy, one report noted that biotechnology companies generally supported the policy but that consumer groups thought it delegated too much of the responsibility for premarketing safety testing to industry. (5) As a result, the report recommended a review of federal oversight of food biotechnology in order to develop a more equitable regulatory balance between promoting industry and protecting the public.

In 1993 the FDA requested public comment on whether and how to label food allergens in transgenic foods, (11) but the agency has not yet reported or taken action on the responses. Although the labeling of transgenic foods raises complex regulatory issues, surveys indicate strong public support for doing so. (12) One reason for labeling is that avoidance is still the best -- and sometimes only -- defense against food allergies. (7) In 1994 the FDA and several other federal agencies held a conference on scientific issues related to the allergenicity of transgenic foods. The participants discussed the gaps in information on food allergies and the need to find ways to identify less common allergens, but they reached no firm conclusions about how to deal with these issues. The FDA has released a transcript of the conference (13) but has not issued a formal report or recommendations.

The FDA has recently drafted a premarketing-notification rule that would require companies to inform the agency when they are developing transgenic foods, in part to help resolve the safety issues related to allergenicity. (14) In the current climate of deregulation, the implementation of any new premarketing-notification rule seems unlikely, particularly since the biotechnology industry is demanding that such a requirement be limited in scope and end after three years. (15) The unresolved status of this regulatory policy means that the responsibility for protecting the public against uncommon or unknown allergens in transgenic foods will continue to be delegated to industry and largely voluntary.

This situation illustrates the pressing need to expand basic and clinical research on food allergies. More information about incidence, prevalence, dietary exposure, antigenicity, immune responses, diagnosis, and treatment would help researchers, regulators, and biotechnology companies predict whether transgenic proteins are likely to cause harm. In the special case of transgenic soybeans, the donor species was known to be allergenic, serum samples from persons allergic to the donor species were available for testing, and the product was withdrawn. The next case could be less ideal, and the public less fortunate. It is in everyone's best interest to develop regulatory policies for transgenic foods that include premarketing notification and labeling. Industry benefits when the public is convinced that transgenic foods are safe, and stronger federal regulations would encourage such public confidence.

References

1. Carroll WL. Introduction to recombinant-DNA technology. Am J Clin Nutr 1993;58:Suppl:249S-258S.
2. Hopkins DD, Goldburg RJ, Hirsch SA. A mutable feast: assuring food safety in the era of genetic engineering. New York: Environmental Defense Fund, 1991.
3. Gaull GE, Goldberg RA, eds. New technologies and the future of food and nutrition. New York: John Wiley, 1991.
4. Food and Drug Administration. Statement of policy: foods derived from new plant varieties. Fed Regist 1992;57(104):22984-3004.
5. General Accounting Office. Food quality and safety: innovative strategies may be needed to regulate new food technologies. Washington, D.C.: General Accounting Office, July 1993. (GAO/RCED-93-142.)
6. Nordlee JA, Taylor SL, Townsend JA, Thomas LA, Bush RK. Identification of a Brazil-nut allergen in transgenic soybeans. N Engl J Med 1996;334:688-92.
7. Sampson HA, Metcalfe DD. Food allergies. JAMA 1992;268:2840-4.
8. Sampson HA, Mendelson L, Rosen JP. Fatal and near-fatal anaphylactic reactions to food in children and adolescents. N Engl J Med 1992;327:380-4.
9. First International Symposium on the Role of Soy in Preventing and Treating Chronic Disease, Mesa, Ariz., February 20-23, 1994: symposium proceedings. J Nutr 1995;125:Suppl:567S-808S.
10. Erdman JW Jr, Fordyce EJ. Soy products and the human diet. Am J Clin Nutr 1989;49:725-37.
11. Food and Drug Administration. Food labeling: foods derived from new plant varieties. Fed Regist 1993;58(80):25837-41.
12. Hoban TJ, Kendall PA. Consumer attitudes about food biotechnology: project summary. Raleigh: North Carolina State University, 1993.
13. Food and Drug Administration, Environmental Protection Agency, Department of Agriculture. Conference on scientific issues related to potential allergenicity in transgenic food crops, Annapolis, Md., April 18-19, 1994. Baltimore: Free State Reporting, 1994. (Docket 3 94N-0053.)
14. Maryanski discusses next wave in biotech, premarket issues. Food Chemical News. January 23, 1995:34-5.
15. BIO favors limited notification on biotech food, 3-year sunset. Food Chemical News. May 16, 1994:7-8.

John B. Fagan, Ph.D., Professor of Molecular Biology

Maharishi University of Management, (Maharishi International University 1971 to 1995), 1000 North Fourth Street, Fairfield, Iowa, 52557-1078, Phone(515) 472-8342, Fax (515) 472-5725, email jfagan@mum.edu

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