Engineered Food and the Fda

To get bioengineered medicines, grains, vegetables, and animals on the market for human consumption, U.S. biotech companies must pass their products through the Food and Drug Administration (FDA).

Recently, the FDA has been in the news because its Prescription Drug User Fee Act of 1992, which forces drug companies to pay in to expedite drug approval, came up for renewal. That same year, the FDA rejected mandatory labeling of genetically modified organism (GMO) products. How might the FDA affect the future of bioengineered food?

The User Fee Act has, in Harvard professor Jerry Avorn’s opinion, “pretty much transformed the FDA. The sense now is we report to the industry; they pay our salaries; we had better be quick on these approvals.”

Some biotech products will zoom through the FDA because they are advances in medical treatment, and, of course, we all want the sick to get the best new therapies. The problem is that the FDA is underfunded, so most resources are dedicated to medical advances. Thus, according to David Kessler of the FDA, “other parts of the agency—post-market surveillance, food safety, the field resources—those areas of the agency suffer.”

In addition, the FDA is essentially rubber-stamping the tests performed by each company that has developed a product, and since they’re bogged down in analysis of drug tests, they hardly ever follow up on the market to see if bioengineered products are having a negative impact on consumers. One publicized mishap in 2000 resulted in traces of StarLink Bt10 corn, meant only for industrial purposes, cross-pollinating with conventional corn and winding up in taco shells. We know the FDA isn’t catching problems like this one–and that, as yet, consuming products deemed marginally unsafe won’t cause an epidemic—but eventually the biotech industry may get consumer backlash for causing a serious problem that could have been avoided if the budget were expanded.

I should probably note that the U.S. Department of Agriculture (USDA) oversaw the restrictions on this brand of corn, and the Department of Health and Human Services, of which the FDA is a part, only posts notices for products consumed by humans—so there’s a further complication for biologically engineered products. They may be subject to these two departments as well as the Environmental Protection Agency, and this structural weakness probably doesn’t make for excellent communication.

One could argue that GMO labeling is only a minor issue in the U.S. and that the average citizen isn’t too concerned about the provenance of his or her food. There are at least two problems with this attitude. The first is that U.S. exports will be increasingly suspect to foreign markets, particularly the EU, which require labeling and stringent testing. The second is that any misstep, such as a genetically engineered product that results in widespread sickness, will create distrust of the FDA and bioengineering in general.

Europe’s vigorous standards regarding approval, track-back, and isolation for GMO crops may be driving North America out of the market. Agricultural specialists like Dan McGuire are questioning if GMO crops are really to their economic advantage.

“I can’t recall any foreign or domestic corn customer ever requesting that U.S. farmers start planting and supplying genetically engineered corn. So the introduction of GMOs was not a response to importers or consumers requesting such a change. Indeed, it’s a direct result of biotech companies introducing those products into the domestic and foreign market without market research on consumer acceptance. Indeed, the first I heard about GMOs was from European importers,” said McGuire.

Leaders in the biotechnology industry need to be activists for their products—labeling their products will bring them one step closer to informing the public and leading us into discussions of benefits like cheaper crop production and less pesticide runoff.

Genetically Modified Foods Is Safe To Eat?

Genetically Modified Foods 

Recent studies have reproven the health risks and side effects of eating genetically modified foods. The studies done back in 1999 by  Dr. Arpad Pusztai, the world’s top GMO safety researcher at the prestigious Rowett Institute in Scotland was working on a UK government grant to design long-term testing protocols intended to become part of the official European GM food safety assessment process. When Pusztai fed supposedly harmless GMOs to rats, they developed potentially pre-cancerous cell growth, smaller brains, livers and testicles, partially atrophied livers, and showed signs of a damaged immune system. Moreover, the results clearly indicated that the cause of the problem was due to the unpredictable side effects arising from the process of genetic engineering itself.

Unfortunately these studies caused quite an uproar upon release. But whats worse, is that U.S media gave the GMO stories and research results practically no coverage. For some reason we as a nation were left in the dark, on more world wide information.

The fact that many of the genetically modified crops are modified by using the BT pesticide. The BT pesticide is injected into the genes of certain crops , such as corn, cotton, and other common food sources. The pesticide are created when the crops reach a certain size as a way to keep the crops from being eaten by insects and bugs that decrease the overall yield of crops.

Unfortunately further test’s have When the test was performed, it was proven that GM food crops can transfer into the DNA of our gut bacteria. This means that long after we stop eating GM corn chips, our intestinal flora might continue to manufacture the “Bt” pesticide that the GM corn plants are engineered to produce. That could be the most substantial research done so far. As if we needed that to know how dangerous pesticides could be to our health. 

As if this wasnt enough, our media still refuses to lend any attention to this evergrowing problem that we face on a daily basis. It is estimated that over 60% to 70% of our overall food crops are grown using genetically modified technologies. 

The worst part? The worst part is that the actual companies that use these GMO technologies, refuse to have genetically modified food sources served in there cafeterias. Believe me, this is documented. As a matter of fact one of the main companies that use the genteically modified grow techniques is Monsanto. And anyone can find out that they will not serve GM food to employee’s. 

That should say quite alot to anyone that thinks that there is not a genetically modified food problem. 

As a matter of fact, all testing aside, there is a documented case of over 10,000 Sheep died within 5 days of grazing on a gentocally modified food source. That is just one of many cases in which GMO’s have cause real harm.

We have limited options as people that wish to avoid eating these dangerous GMO’s. But we must stop buying food that is grown using genetically modified technologies.

Eating Organic food is 1 of 2 options we have if we want to stick to a safe diet and avoid gmo’s. The other is growing our own Organic food supply.

By using 100% organic seed’s, we will not only be able to eat healthy, but these organic seed’s arent like normal seed’s. You see, even the seed’s sold in most stores are modified. They are created so that you will only get 1 season out of each seed. When you use the organic seeds, you will never have to buy seed’s again.

Its cheaper, healthier, and you will not be forced into buying organic food at outrageous prices.

For more information on growing healthy , Organic Gardens -

Click Here For Completely Organic Seeds

 

What are Genetically Modified Foods?

Should patents on plants, animals and humans, as well as patents on their genes be allowed? Our ability to alter the genetic blueprint of animals and plants is in the process of changing many aspects of science and medicine. Many people see this as beneficial others see this as tampering with nature.

But what about genetically-modified (GM) food? Do we want to eat such food? And is it really such a big deal?

Genetic engineering enables scientists to create plants, animals and micro-organisms by manipulating genes in a way that does not occur naturally.

A recent GM Nation report concluded that the general public is overwhelmingly against GM technology, with feelings ranging from suspicion and skepticism, to hostility and rejection; there are, it was said, many more people who are cautious, suspicious or out rightly hostile about GM crops than there are supportive towards them.

Anxiety in society over genetically modified food is understandable, fuelled by a variety of causes – consumer unfamiliarity; lack of reliable information on the current safeguards in place; a steady stream of negative opinion in the media; opposition by activist groups; growing mistrust of industry; and a general lack of awareness of how our food is produced. The scientific community has not adequately addressed public concerns about GM foods, nor has it effectively communicated the value of the new technology.

The Royal Society, the UKs premier scientific body has pointed out the total lack of evidence that genetically modified crops cause harm to humans. But youd never have guessed that from the often negative media coverage.

When considering genetic engineering, it should be remembered that almost every living thing that man exploits has been genetically-modified in some way. The crops we use for food, the animals we eat, our pets and the plants in our gardens are radically different from those that existed in the so-called natural state.

Thousands of years of selective breeding have improved the yields of crops, the milk production of cows, the quantity of meat on cattle and the sizes and colours of our flowers and dogs.

But because of commercial interests, the public is being denied the right to know about GE ingredients in the food chain, and therefore losing the right to avoid them despite the presence of labelling laws in certain countries. GMOs should not be released into the environment as there is not adequate scientific understanding of their impact on the environment and human health. Genetic pollution could be a major threat because GMOs cannot be recalled once released into the environment. Labelling of all products with GE ingredients doesnt appear to be happening at the moment which is important for those people that want to avoid them.

Now my final thoughts… few would deny the benefits of modern genetic engineering in medicine. The use of genetically-modified bacteria to produce drugs such as insulin has been a revolution in medicine and saved the lives of millions. GM crops have also been hailed as the saviors of developing countries as they can be modified to prosper in dry, arid countries where there is little rainfall. There seems to be both negatives and positives to GE and GM foods….ill let you decide which path you choose!

Find Organic GM Free Food in the Green Directory.

See www.agbioworld.org for information on supporting technology in Agriculture.

?no to Genetically Modified Foods?

Introduction:

            Genetics is the basis of life. Every living being around, carries a plethora of genes, some are expressed while others may remain unexpressed all through the life of the organism. The nature has bestowed mankind with the best genetics on the planet. Utilizing the brain potentials man has revealed the secrets hidden in the nature and has taken charge of altering the hereditary matter of plants and animals and also of the food items that he consumes. Are these food items really helping human beings or they are providing deleterious effects to mankind. This question became the controversy in southern Africa drought in 2002/03 (Pelletier, 2006).

            At present much emphasis is being laid on the health and healthy food which encompass all the natural products which have not undergone any alteration and have preserved their natural and gifted genes i.e. they are directly from the natural sources. Various ailments are due to the food consumption only as content in the food can trigger any cell or enzyme as soon as it is consumed. Taking this into consideration the US FDA has been established. This body has set different rules and regulations for the altered food and beverages.

“Genetically Engineered” food is grown, manufactured, created, developed or changed by utilizing the techniques that brings changes in molecular or cell biology of an organism. This technique cannot be exploited in nature or under natural conditions. These techniques are mostly based on recombinant DNA technology, cell fusion, micro- and macroencapsulation, gene deletion or duplication, introduction of any gene from other organism through microinjection or by the process of transgenesis where the desired foreign gene is inserted in the early sates of development and also the techniques based on altering the position of the genes. The process does not include propagation, conjugation, fermentation, hybridization, in vitro fertilization and tissue culture method (Grubesic, 2005).

            GE food is changing the nature and it is challenging the nature. Laws have been put forward for the GE and this is cited as “genetically Engineered Food Labeling Act”. The purpose of this Act enforces the primary right of the people and it is for the awareness of the people if anyone is buying or selling such product (Grubesic, 2005).

These products could be:

Agriculture product: Farming or horticulture, viticulture or vegetable items for consumption. This also includes food additives (incorporation of this item in food influence the characteristic of food).

Food additives may be used for manufacturing, stuffing or in packaging, dispensation, preparing, treating, and packaging, food additives may also be used when long distance transporting is to be done or when the food item is to be kept for long duration. Now-a-days radiations are given to ensure the safety of food from chemicals.

The food is labeled with the name of the company or firm or by any legal or commercial entity; it also displays the customary conditions of display for bulk, wholesale or retail sale. The GE food must be labeled with “Genetically Engineered” tag.

The GE can be performed for the GE enzymes, or the GE processing agents. It is significant that customer must know if the enzymes are present in the food item or what is the nature of GE agent.

Genetic Engineered food items are prevalent in almost every field:

Agriculture: GE or hybrid seeds, fruits, vegetables, plants are gaining popularity in market. It requires awareness and thorough knowledge for consumption.

Dairy or meat products: these are the products derived from livestock. It not only encompasses transgenic animals but also incorporate the feed of the livestock. The gene for the milk production of the cattle is altered to get the enhanced milk production. The process does not end here the milk obtained is processed and treated with GE agents especially the enzymes to get a range of milk products.

            It is evident that GE food is modified in composition or nutritional values. In order to prepare such product diverse processes are performed. These processes may alter the food value or the quality of the food because these products are made from the trans-species that encompass gene transfers from some different species or genera. It is mandatory to provide written information to the consumers e.g. “This squash contains viral genetic information designed to make it resistant to viral infection.” or “This tomato contains genetic material derived from the flounder, a fish of the family Bothidiae.” (Grubesic, 20005).

            Various research and studies have been performed where the disadvantages of GE food items are highlighted. It is apparent that in this fast moving life and also in the rat race man has taken shelter under the GE food and all the artificial flavored items. Mankind escapes all the natural food items available just to cut the time in home processing.

            This practice is gradually creeping in our own heredity and genetic makeup. The agents used to alter the food items are in turn harmful to mankind and has started bringing disaster. One of the leading causes of the cancer is consumption of those food items that are not natural but are artificially made or its genes are altered or processed so as to ensure that only the desired genes are expressed. Here the expression of genes in the cell is not under the natural control but they are influenced by the inducing factors. The process can give fast momentary results but it cannot substitute the natural articles (Campbell).

            The haste to produce additional quantity, to capture the market or for survival in the market various organizations are adopting fallacies. New companies are coming up and they put political influence on and FDA, exploiting and violating the permissive regulatory approach, infringing the research and scientific findings.

It is evident that violating Food Law is a severe offence. The government and the authorities must take the honest and worthy approach to confirm the GE item consumption and safety is equivalent to conventional food items (Pelletier, 2006).

            It becomes the responsibility of people and consumers to be aware of such products to safeguard our heath and to avoid the misleading facts unless thoroughly examined and checked and verified scientifically; else, say no to genetically engineered food products.

Genetically Modified Organisms,kenya

A genetically modified organism (GMO) or genetically engineered organism (GEO) is an organism whose genetic material has been altered using genetic engineering techniques. These techniques, generally known as recombinant DNA technology, use DNA molecules from different sources, which are combined into one molecule to create a new set of genes. This DNA is then transferred into an organism, giving it modified or novel genes. Transgenic organisms, a subset of GMOs, are organisms which have inserted DNA that originated in a different species. Some GMOs contain no DNA from other species and are therefore not transgenic but cisgenic.

What are genetically-modified foods?

The term GM foods or GMOs (genetically-modified organisms) is most commonly used to refer to crop plants created for human or animal consumption using the latest molecular biology techniques. These plants have been modified in the laboratory to enhance desired traits such as increased resistance to herbicides or improved nutritional content. The enhancement of desired traits has traditionally been undertaken through breeding, but conventional plant breeding methods can be very time consuming and are often not very accurate. Genetic engineering, on the other hand, can create plants with the exact desired trait very rapidly and with great accuracy. For example, plant geneticists can isolate a gene responsible for drought tolerance and insert that gene into a different plant. The new genetically-modified plant will gain drought tolerance as well. Not only can genes be transferred from one plant to another, but genes from non-plant organisms also can be used. The best known example of this is the use of B.t. genes in corn and other crops. B.t., or Bacillus thuringiensis, is a naturally occurring bacterium that produces crystal proteins that are lethal to insect larvae. B.t. crystal protein genes have been transferred into corn, enabling the corn to produce its own pesticides against insects such as the European corn borer.

What are some of the advantages of GM foods?

The world population has topped 6 billion people and is predicted to double in the next 50 years. Ensuring an adequate food supply for this booming population is going to be a major challenge in the years to come. GM foods promise to meet this need in a number of ways:

 Pest resistance:Crop losses from insect pests can be staggering, resulting in devastating financial loss for farmers and starvation in developing countries. Farmers typically use many tons of chemical pesticides annually. Consumers do not wish to eat food that has been treated with pesticides because of potential health hazards, and run-off of agricultural wastes from excessive use of pesticides and fertilizers can poison the water supply and cause harm to the environment. Growing GM foods such as B.t. corn can help eliminate the application of chemical pesticides and reduce the cost of bringing a crop to market.

 Herbicide tolerance:For some crops, it is not cost-effective to remove weeds by physical means such as tilling, so farmers will often spray large quantities of different herbicides (weed-killer) to destroy weeds, a time-consuming and expensive process, which requires care so that the herbicide doesn’t harm the crop plant or the environment. Crop plants genetically-engineered to be resistant to one very powerful herbicide could help prevent environmental damage by reducing the amount of herbicides needed. For example, Monsanto has created a strain of soybeans genetically modified to be not affected by their herbicide product Roundup. A farmer grows these soybeans which then only require one application of weed-killer instead of multiple applications, reducing production cost and limiting the dangers of agricultural waste run-off.

 Disease resistance:There are many viruses, fungi and bacteria that cause plant diseases. Plant biologists are working to create plants with genetically-engineered resistance to these diseases.

 Cold tolerance:Unexpected frost can destroy sensitive seedlings. An antifreeze gene from cold water fish has been introduced into plants such as tobacco and potato. With this antifreeze gene, these plants are able to tolerate cold temperatures that normally would kill unmodified seedlings.

 Drought tolerance/salinity tolerance:As the world population grows and more land is utilized for housing instead of food production, farmers will need to grow crops in locations previously unsuited for plant cultivation. Creating plants that can withstand long periods of drought or high salt content in soil and groundwater will help people to grow crops in formerly inhospitable places.

 Nutrition:Malnutrition is common in third world countries where impoverished peoples rely on a single crop such as rice for the main staple of their diet. However, rice does not contain adequate amounts of all necessary nutrients to prevent malnutrition. If rice could be genetically engineered to contain additional vitamins and minerals, nutrient deficiencies could be alleviated. For example, blindness due to vitamin A deficiency is a common problem in third world countries. Researchers at the Swiss Federal Institute of Technology Institute for Plant Sciences have created a strain of “golden” rice containing an unusually high content of beta-carotene (vitamin A). Since this rice was funded by the Rockefeller Foundation, a non-profit organization, the Institute hopes to offer the golden rice seed free to any third world country that requests it. Plans were underway to develop golden rice that also has increased iron content. However, the grant that funded the creation of these two rice strains was not renewed, perhaps because of the vigorous anti-GM food protesting in Europe, and so this nutritionally-enhanced rice may not come to market at all.

 Pharmaceuticals:Medicines and vaccines often are costly to produce and sometimes require special storage conditions not readily available in third world countries. Researchers are working to develop edible vaccines in tomatoes and potatoes. These vaccines will be much easier to ship, store and administer than traditional injectable vaccines.

 Phytoremediation:Not all GM plants are grown as crops. Soil and groundwater pollution continues to be a problem in all parts of the world. Plants such as poplar trees have been genetically engineered to clean up heavy metal pollution from contaminated soil.

What are some of the criticisms against GM foods?

Environmental activists, religious organizations, public interest groups, professional associations and other scientists and government officials have all raised concerns about GM foods, and criticized agribusiness for pursuing profit without concern for potential hazards. It seems that everyone has a strong opinion about GM foods. Even the Vatican and the Prince of Wales have expressed their opinions. Most concerns about GM foods fall into three categories: environmental hazards, human health risks, and economic concerns.

Environmental hazards

 Unintended harm to other organisms:Last year a laboratory study showed that pollen from B.t. corn caused high mortality rates in monarch butterfly caterpillars. Monarch caterpillars consume milkweed plants, not corn, but the fear is that if pollen from B.t. corn is blown by the wind onto milkweed plants in neighboring fields, the caterpillars could eat the pollen and perish. Although the Nature study was not conducted under natural field conditions, the results seemed to support this viewpoint. Unfortunately, B.t. toxins kill many species of insect larvae indiscriminately; it is not possible to design a B.t. toxin that would only kill crop-damaging pests and remain harmless to all other insects. This study is being reexamined by the USDA, the U.S. Environmental Protection Agency (EPA) and other non-government research groups, and preliminary data from new studies suggests that the original study may have been flawed. This topic is the subject of acrimonious debate, and both sides of the argument are defending their data vigorously. Currently, there is no agreement about the results of these studies, and the potential risk of harm to non-target organisms will need to be evaluated further.

 Reduced effectiveness of pesticides:Just as some populations of mosquitoes developed resistance to the now-banned pesticide DDT, many people are concerned that insects will become resistant to B.t. or other crops that have been genetically-modified to produce their own pesticides.

 Gene transfer to non-target species:Another concern is that crop plants engineered for herbicide tolerance and weeds will cross-breed, resulting in the transfer of the herbicide resistance genes from the crops into the weeds. These “superweeds” would then be herbicide tolerant as well. Other introduced genes may cross over into non-modified crops planted next to GM crops. The possibility of interbreeding is shown by the defense of farmers against lawsuits filed by Monsanto. The company has filed patent infringement lawsuits against farmers who may have harvested GM crops. Monsanto claims that the farmers obtained Monsanto-licensed GM seeds from an unknown source and did not pay royalties to Monsanto. The farmers claim that their unmodified crops were cross-pollinated from someone else’s GM crops planted a field or two away. More investigation is needed to resolve this issue.

 There are several possible solutions to the three problems mentioned above. Genes are exchanged between plants via pollen. Two ways to ensure that non-target species will not receive introduced genes from GM plants are to create GM plants that are male sterile (do not produce pollen) or to modify the GM plant so that the pollen does not contain the introduced gene. Cross-pollination would not occur, and if harmless insects such as monarch caterpillars were to eat pollen from GM plants, the caterpillars would survive.
 Another possible solution is to create buffer zones around fields of GM crops. For example, non-GM corn would be planted to surround a field of B.t. GM corn, and the non-GM corn would not be harvested. Beneficial or harmless insects would have a refuge in the non-GM corn, and insect pests could be allowed to destroy the non-GM corn and would not develop resistance to B.t. pesticides. Gene transfer to weeds and other crops would not occur because the wind-blown pollen would not travel beyond the buffer zone. Estimates of the necessary width of buffer zones range from 6 meters to 30 meters or more. This planting method may not be feasible if too much acreage is required for the buffer zones.

Human health risks

 Allergenicity:Many children in the US and Europe have developed life-threatening allergies to peanuts and other foods. There is a possibility that introducing a gene into a plant may create a new allergen or cause an allergic reaction in susceptible individuals. A proposal to incorporate a gene from Brazil nuts into soybeans was abandoned because of the fear of causing unexpected allergic reactions. Extensive testing of GM foods may be required to avoid the possibility of harm to consumers with food allergies. Labeling of GM foods and food products will acquire new importance.

 Unknown effects on human health:There is a growing concern that introducing foreign genes into food plants may have an unexpected and negative impact on human health. A recent article published in Lancet examined the effects of GM potatoes on the digestive tract in rats. This study claimed that there were appreciable differences in the intestines of rats fed GM potatoes and rats fed unmodified potatoes. Yet critics say that this paper, like the monarch butterfly data, is flawed and does not hold up to scientific scrutiny. Moreover, the gene introduced into the potatoes was a snowdrop flower lectin, a substance known to be toxic to mammals. The scientists who created this variety of potato chose to use the lectin gene simply to test the methodology, and these potatoes were never intended for human or animal consumption.

 On the whole, with the exception of possible allergenicity, scientists believe that GM foods do not present a risk to human health.

Economic concerns

 Bringing a GM food to market is a lengthy and costly process, and of course agri-biotech companies wish to ensure a profitable return on their investment. Many new plant genetic engineering technologies and GM plants have been patented, and patent infringement is a big concern of agribusiness. Yet consumer advocates are worried that patenting these new plant varieties will raise the price of seeds so high that small farmers and third world countries will not be able to afford seeds for GM crops, thus widening the gap between the wealthy and the poor. It is hoped that in a humanitarian gesture, more companies and non-profits will follow the lead of the Rockefeller Foundation and offer their products at reduced cost to impoverished nations.

 Patent enforcement may also be difficult, as the contention of the farmers that they involuntarily grew Monsanto-engineered strains when their crops were cross-pollinated shows. One way to combat possible patent infringement is to introduce a “suicide gene” into GM plants. These plants would be viable for only one growing season and would produce sterile seeds that do not germinate. Farmers would need to buy a fresh supply of seeds each year. However, this would be financially disastrous for farmers in third world countries who cannot afford to buy seed each year and traditionally set aside a portion of their harvest to plant in the next growing season. In an open letter to the public, Monsanto has pledged to abandon all research using this suicide gene technology.

Conclusion

Genetically-modified foods have the potential to solve many of the world’s hunger and malnutrition problems, and to help protect and preserve the environment by increasing yield and reducing reliance upon chemical pesticides and herbicides. Yet there are many challenges ahead for governments, especially in the areas of safety testing, regulation, international policy and food labeling. Many people feel that genetic engineering is the inevitable wave of the future and that we cannot afford to ignore a technology that has such enormous potential benefits. However, we must proceed with caution to avoid causing unintended harm to human health and the environment as a result of our enthusiasm for this powerful technology.

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