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Safety Testing for GMOs and More News

Safety Testing for GMOs and More News


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In today's Media Mix, China's food safety problems, plus new research on red wine and migraines

The Daily Meal's Media Mix brings you the biggest news around the food world.

Safety Testing for GMOs Recommended: The American Medical Association recommended that there should be pre-market testing for safety for all GMOS before they enter the food supply. [Chicago Tribune]

More Problems in China's Food Safety: In other food safety news, China continues to be plagued with more food safety scandals; local media say the highly publicized mercury in baby formula is only the tip of the iceberg. [New York Times]

Not All Red Wine Causes Headaches: Despite red wine's bad rep that it can cause more headaches, it's only those with high amounts of tannins that cause headaches. [WebMD]

Andrew Carmellini to Open New Restaurant: Daniel Boulud's mentee will open the restaurant in the spcae formerly known as Chinatown Brasserie. [New York Times]

Jamie Oliver Criticizes UK's Food Initiatives: The chef and public health advocate has "lost faith" in the UK's ability to improve school nutrition. [Huffington Post]


GMO safety debate is over

Mark Lynas

The GMO debate is over again. Last week, the prestigious National Academies of Science, Engineering and Medicine issued what is probably the most far-reaching report ever produced by the scientific community on genetically engineered food and crops. The conclusion was unambiguous: Having examined hundreds of scientific papers written on the subject, sat through hours of live testimony from activists and considered hundreds more comments from the general public, the scientists wrote that they “found no substantiated evidence that foods from GE crops were less safe than foods from non-GE crops.”

The National Academies process was both impressively inclusive and explicitly consensual. As noted in the preface to their report, the scientists “took all of the comments” however ludicrous “as constructive challenges” and considered them carefully. Thus the expert committee patiently gave yogic flyer-turned-anti-GMO activist Jeffrey Smith a generous 20-minute slot within which to make his customary assertion that genetically engineered foods cause just about every imaginable modern ailment. Greenpeace also offered invited testimony. So did Giles-Eric Seralini, the French professor who suffered the ultimate scientific indignity of having his paper claiming rats fed GMOs suffered tumors retracted in 2013.

Each of their claims was examined in turn. Do GE foods cause cancer? No patterns of changing cancer incidence over time are “generally similar” between the US, where GMO foods are ubiquitous, and the United Kingdom, where they are virtually unknown. How about kidney disease? US rates have barely budged over a quarter century. Obesity or diabetes? There is “no published evidence to support the hypothesis” of a link between them and GE foods. Celiac disease? “No major difference” between the US and UK again. Allergies? “The committee did not find a relationship between consumption of GE foods and the increase in prevalence of food allergies.” Autism? Again, evidence comparing the US and UK “does not support the hypothesis of a link.”

In a rational world, everyone previously fearful about the health effects of GMOs would read the report, breathe a huge sigh of relief and start looking for more evidence-based explanations for worrying trends in health issues like diabetes, autism and food allergies. But psychological associations developed over many years are difficult to break. A Pew Center poll in 2015 found only 37 percent of the public thought GE foods were safe, as compared to 88 percent of scientists, a greater gap than on any other issue of scientific controversy, including climate change, evolution and childhood vaccinations. These entrenched attitudes are not about to disappear especially since they are continually reinforced by a vocal and well-funded anti-GMO lobby.

There is also political path dependence. Vermont’s GMO labeling law, scheduled to throw US food manufacturers and retailers into chaos when it comes into force on July 1, is predicated on the explicit assumption that GE foods may be unsafe. “There is a lack of consensus regarding the validity of the research and science surrounding the safety of genetically engineered foods,” Vermont’s Act states in its preamble. Indeed, such foods “potentially pose risks to health [and] safety. Will Vermont’s legislature reconsider its Act now that it stands so clearly on the wrong side of a rock-solid scientific consensus? Of course not.

The National Academies report should make particularly uncomfortable reading for the environmental movement, many of whose leading member groups now exhibit all the hallmarks of full-scale science denialism on the issue. A spokeswoman from Friends of the Earth dismissed the report as “deceptive” before she had even read it. The group’s website claims that “numerous studies” show GE foods can pose “serious risks” to human health. Another environmentalist group, Food and Water Watch, issued a pre-publication rebuttal that conspiratorially accused the National Academies of having undisclosed links with Monsanto, before reasserting its view that “there is no consensus, and there remains a very vigorous debate among scientists… about the safety and merits of this technology.”

But despite these shrill denials, the truth is that there is no more of a debate on the safety of GE crops than on reality of climate change, the scientific consensus on which all these same green groups aggressively defend. And the irony goes deeper: many of the strategies now being employed to demonize GMOs come straight out of the climate denialist playbook. There’s the same promotion of false ‘no consensus’ statements by groups of self-appointed experts. Why, more than 300 “scientists and legal experts” signed a ‘no consensus on GMO safety’ statement last year, Greenpeace reminds us. That sounds like a lot, until you compare it with the 30,000 “American scientists” who have supposedly signed a petition claiming that there is “no convincing scientific evidence” linking CO2 with climate change, which Greenpeace (rightly in my view) ignores.

There’s also a worrying trend towards the harassment of bona fide scientists. Just as senior Republicans have shamefully targeted climate experts with politically-motivated subpoenas, so an anti-GMO group called US Right to Know has slapped dozens of geneticists and molecular biologists working at public universities with repeated Freedom of Information Act requests demanding access to thousands of their private emails. In some cases, scientists have as a result of subsequent campaigns received death threats, and had their laboratory and home addresses circulated menacingly on social media.

There is still plenty of room for genuine dissent moreover. The National Academies report is zealous in pointing out some of the experienced difficulties and drawbacks of GMOs. The overuse of GE crops has indeed led to the evolution of resistance, both in weeds and insects, it finds. Also, industry domination of the technology might restrict access of small farmers in poorer countries to improved seeds. And mandatory GMO labelling might well be a good way to raise public trust in a more transparent food system.

But these real areas of debate do not include GMO safety. That issue has now been definitively put to bed. So let’s be clear once again: the safety debate is over. If you vaccinate your kids and believe that climate change is real, you need to stop being scared of genetically modified foods.

Mark Lynas is a writer and campaigner on climate change and a visiting fellow at the Cornell Alliance for Science


Understanding the biology behind GMOs can help consumers evaluate GMO safety

What are GMOs (genetically modified organisms) and are they safe to eat? It can be difficult for a consumer to sort through and understand the information in the media and on food labels regarding food production methods and food safety. When it comes to GMOs, which refer to genetically modified (GM) crops resulting from a modern breeding method called genetic engineering, there is a great deal of information. Some information is accurate, some not, and some misleading. However, according to a Pew survey, there is much agreement among scientists about the safety of GMO plants and products for human consumption.

Based on hundreds of research studies, more than 280 food safety agencies, and scientific and technical institutions throughout the world (Table 1), support the safety of GMO technology (genetic engineering) to modify traits in plants. This includes the Food and Drug Administration (U.S. FDA), the European Food Safety Authority, and the World Health Organization. Despite the scientific consensus on safety, consumer concerns abound. Such concerns often include environmental, agricultural production, economic, and social justice aspects. This article deals specifically with food safety.

National Academy of Sciences - May 2016

Society of Toxicology - September 2002 - Consensus position statement

National Research Council - National Academy of Sciences

American Medical Association

Institute of Food Technologists

American Dietetic Association

European and International

France - French Academy of Medicine - 2003

Italy - Eighteen scientific associations - October 2004 (including National Academy of Science, Societies for Toxicology, Microbiology, Nutrition, Biochemistry) signed consensus statement on safety of GMO crops

FAO - Food and Agriculture Organization

WHO - World Health Organization

International Council for Science - 2005, 2010 (111 National Academies of Science and 29 scientific unions)

What is a GMO?

Some people cringe at the words &ldquogenetically modified organism&rdquo, but genetic modification is an important method people have used for the past 10,000-30,000 years while they domesticated both crops and animals. When plants and animals are selectively mated, the genes from both parents are mixed and many inherited traits are changed, which can be readily observed in the wide varieties of certain species, such as dog breeds. Without much knowledge about genetics, plants and animals were purposefully changed when people observed differences in plants and animals, and then mated what appeared to be the &ldquobest&rdquo ones to create and/or preserve beneficial traits and characteristics.

Today, several different breeding methods are used to improve plants, including the traditional methods (when possible). Regardless of method, all involve modifying the genetic makeup, or genes, of an organism. All living organisms -plants, animals, microbes- have genes, and all genes are made of DNA (Deoxyribonucleic Acid), which is the universal coding system that determines traits such as crop yield, height, hair color, horns, etc.

In contrast to a plant created by modifying its DNA using traditional breeding methods, a GMO plant is created using a newer, more controlled method referred to as genetic engineering. This method changes plants by inserting a gene from another organism to add a useful trait to the recipient organism, such as disease or pest resistance. With genetic engineering, the DNA can come from organisms that cannot mate with the crop being modified, e.g., bacteria, fungi or another crop or unrelated plant. For example, one might move a drought tolerant gene from a drought tolerant plant to a corn plant. Since the 1980s, an important GMO is bacteria that have been modified to produce human insulin. These bacteria resulted from inserting the human gene for insulin into the bacteria DNA, so they can produce the human insulin protein. Bacteria produce about 90 percent of human insulin today.

With genetic engineering, usually only one gene from the donor, with a known role or coding for a known protein, is added or inserted into the current set of genes of a recipient plant. In contrast, traditional breeding methods mix many genes (from similar plants) in the mating process. Further, the resulting plants or offspring could have multiple and/or unpredictable outcomes, some of which can be undesirable (e.g., negative impact on yield, quality, or flavor).

Within the past decade, an even more precise method of genetic engineering has been developed called gene editing. This method simply &ldquoedits&rdquo the DNA code of a gene in an organism to modify its expression, instead of introducing a new gene, to give the organism certain characteristics such as more drought tolerant or nutritious. Related techniques can also be used to insert a new gene from another organism into a precise location in the organism&rsquos DNA.

What are Genes and DNA?

Genes provide the instructions for the cells of plants and animals to do their work. Genes are made of units of DNA, represented by the letters A, T, G and C, which form thread-like chains of molecules that look like a twisted ladder (Figure 1). DNA code is similar to the binary code system in computers, which uses &ldquo0&rdquo and &ldquo1&rdquo in different arrangements to create messages or computer instructions. With DNA, combinations of A, T, G, and C form each gene and genes code for various proteins (Figure 1). Proteins in plant and animal cells control various functions of the cell and organism. All methods used to genetically modify plants change DNA, including naturally occurring mutations, resulting in changes in the genetic code. A simple example of a mutation or a change in the code would be changing a G to T. Click here to learn more.

Figure 1. Genes are made of sequences of DNA which form thread-like chains and code for specific proteins that control cell functions.

Are Genes and DNA safe to eat?

Virtually everything we eat comes from a plant, animal, or fungal source. That means it either has genes (DNA) in it or if it was highly processed, such as oil and sugars which no longer contain DNA, it was extracted from an organism that had genes. This means we are constantly eating genes (DNA), whether modified by traditional breeding methods, natural mutations or genetic engineering. Our digestive tract breaks down DNA in the same way, regardless of the source and regardless of the DNA sequence.

Nonetheless, proteins produced by the new genes, and the resultant crop products, must be tested for safety. For this reason, whenever a new plant variety is created using genetic engineering in the U.S., the new variety undergoes rigorous testing for allergens, toxins and modified nutritional content, based on FDA and international food safety standards. All GM products currently on the market have been approved by and are regulated by the FDA. For a greater understanding of testing genetic engineered plants, see a discussion by Professor Robert Hollingworth from the Michigan State University Center for Research on Ingredient Safety (CRIS).

Why use GMO Crops?

All farmers face challenges from insects, disease, weeds and weather in their efforts to cultivate healthy, productive crops. Genetic engineering provides another tool to deal with some of these challenges.

Some examples of traits that have been added to plants using genetic engineering include:

  • Disease resistance
  • Drought resistance
  • Insect resistance
  • Herbicide tolerance
  • Improved nutrition (e.g., adding Vitamin A production in golden rice to prevent deficiencies in third-world countries and increasing protein in cassava)

There are ten crops that have been approved GM varieties in the United States as of 2018:

  • Corn (field and sweet)
  • Soybeans
  • Cotton
  • Alfalfa
  • Sugar beets
  • Canola
  • Papaya
  • Summer squash
  • Innate potatoes
  • Non-browing Arctic apples

In the case of corn, soybeans, cotton, sugar beets, and papaya over 90 percent of the acreage in the U.S. consists of genetically-engineered varieties. Farmers have quickly adopted crops produced by this technology because they reduce losses from pests, and reduce production costs, pesticide use, and the carbon footprint (National Academy of Sciences). For all of the other approved GM crops, only a small proportion is GMO.

Foods in U.S. stores today might contain products from GM corn, soybeans, canola, or sugar beets. However, processed oils or sugars from these crops are refined products and do not contain DNA or proteins.

Summary

The topic of GMOs is very important to many individuals and organizations because it involves questions related to food safety, human health, ecosystem health, and the ability to continue to make genetic improvements of plants. The GMO debate is likely to continue for many years because of the complexity and strong opinions on the topic, as well as the economic impacts that may influence interest groups on both sides of the debate. GMOs continue to be researched, new methods are evolving and with new information, comes new points for discussion.

Understanding some basic biology and the processes of plant breeding can help individuals understand GMOs and their safety. When looking for information, be sure to seek information from institutions and agencies that share science-based, objective results. Several university Extension services are now offering easy-to-use websites for those seeking accessible and reputable information about the safety of GMOs. Michigan State University AgBioResearch devoted an entire issue of its Futures Magazine to: &ldquoThe Science behind GMOs&rdquo. The Food and Drug Administration as well as the World Health Organization also have useful information on GMOs.

Virtually all that we eat today, whether plants or animals, has had its DNA altered by humans for thousands of years. The DNA that is modified consists of the same building blocks (DNA) whether the organism is genetically engineered or not. It is the arrangement of the DNA that makes any altered organism different from another, not if DNA is modified by natural mutation or various breeding methods (traditional breeding methods or genetic engineering).

In a nutshell, genetic engineering in plants is a more recent and more precise method of producing plants with desirable traits. Changing the DNA in plants has no influence on the safety of the DNA because we readily digest the strands of DNA as we always have. The proteins created by the new DNA are tested in accordance with FDA guidelines, to ensure that they are safe to consume.

References:

  • Funk, C., L. Rainie. Public and Scientists&rsquo Views on Science and Society, Pew Research Center. http://www.pewinternet.org/2015/01/29/public-and-scientists-views-on-science-and-society/
  • MSU Today. 2018. GMOs 101. Michigan State University https://msutoday.msu.edu/feature/2018/gmos-101/
  • Sí Quiero Transgénicos. 2017. http://www.siquierotransgenicos.cl/2015/06/13/more-than-240-organizations-and-scientific-institutions-support-the-safety-of-gm-crops/
  • National Academies of Sciences, Engineering, and Medicine. 2016. Genetically
  • Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi:10.17226/23395. http://www.nap.edu/23395
  • The Science Behind GMOs. 2018. Michigan State University AgBioResearch. http://www.canr.msu.edu/publications/the-science-behind-gmos

Learn more:

This article was published by Michigan State University Extension. For more information, visit https://extension.msu.edu. To have a digest of information delivered straight to your email inbox, visit https://extension.msu.edu/newsletters. To contact an expert in your area, visit https://extension.msu.edu/experts, or call 888-MSUE4MI (888-678-3464).

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Are G.M.O. Foods Safe?

It’s human nature, it seems, to resist change and fear the unknown. So it is no surprise that genetic engineering of food and feed crops resulted in their resounding condemnation as “Frankenfoods” by many consumers, who seem as terrified of eating an apple with an added anti-browning gene or a pink pineapple genetically enriched with the antioxidant lycopene as I am of self-driving cars.

Trek down the grocery aisles of any large market and you’ll find many products prominently labeled “No G.M.O.s.” It’s much harder to spot the small print on many other foods stating “Partially produced with genetic engineering,” a result of a 2016 federal law that mandated uniform labeling of all food products containing genetically engineered ingredients.

The labeling requirement arose in response to public pressure and a confusing array of state rules. But while I endorse the public’s right to know and honest labeling of all products, in an important way it is very misleading. Farmers and agricultural scientists have been genetically engineering the foods we eat for centuries through breeding programs that result in large and largely uncontrolled exchanges of genetic material. What many consumers may not realize: For many decades, in addition to traditional crossbreeding, agricultural scientists have used radiation and chemicals to induce gene mutations in edible crops in attempts to achieve desired characteristics.

Modern genetic engineering differs in two ways: Only one or a few new genes with a known function are introduced into a crop, and sometimes the new genes come from an unrelated species. Thus, a gene meant to instill frost tolerance into, say, spinach, might come from a fish that lives in icy waters.

In the decades since the first genetically modified foods reached the market, no adverse health effects among consumers have been found. This is not to say there are none, but as hard as opponents of the technology have looked, none have yet been definitely identified.

Although about 90 percent of scientists believe G.M.O.s are safe — a view endorsed by the American Medical Association, the National Academy of Sciences, the American Association for the Advancement of Science and the World Health Organization — only slightly more than a third of consumers share this belief.

It is not possible to prove a food is safe, only to say that no hazard has been shown to exist. The fears of G.M.O.s are still theoretical, like the possibility that insertion of one or a few genes could have a negative impact on other desirable genes naturally present in the crop.

Among commonly expressed concerns — again, none of which have been clearly demonstrated — are unwanted changes in nutritional content, the creation of allergens and toxic effects on bodily organs. According to an interview in Scientific American with Robert Goldberg, a plant molecular biologist at the University of California, Los Angeles, such fears have not yet been quelled despite “hundreds of millions of genetic experiments involving every type of organism on earth and people eating billions of meals without a problem.”

Establishing long-term safety would require prohibitively expensive decades of study of hundreds of thousands of G.M.O. consumers and their non-G.M.O. counterparts.

Meanwhile, a number of impressive benefits have been well established. For example, an analysis of 76 studies published in February in Scientific Reports by researchers in Pisa, Italy, found that genetically engineered corn has a significantly higher yield than non-genetically modified varieties and contains lower amounts of toxins commonly produced by fungi.

Both effects most likely stem from the genetically engineered resistance to a major insect pest, the western corn rootworm, which damages ears of corn and allows fungi to flourish. The researchers said that the change has had little or no effect on other insects.

By engineering resistance to insect damage, farmers have been able to use fewer pesticides while increasing yields, which enhances safety for farmers and the environment while lowering the cost of food and increasing its availability. Yields of corn, cotton and soybeans are said to have risen by 20 percent to 30 percent through the use of genetic engineering.

Billions of edible animals are raised in this country each year on feed containing G.M.O.s, with no evidence of harm. In fact, animal health and growth efficiency actually improved on the genetically engineered feed, according to a 2014 review in the Journal of Animal Science.

Wider adoption of genetic engineering, especially in African and Asian countries that still spurn the technology, could greatly increase the food supply in areas where climate change will increasingly require that crops can grow in dry and salty soils and tolerate temperature extremes. I continue to be distressed by the resistance to Golden Rice, a crop genetically engineered to supply more vitamin A than spinach that could prevent irreversible blindness and more than a million deaths a year.

Nonetheless, gene modification scientists are focusing increasingly on building health benefits into widely used foods. In addition to pink pineapples containing the tomato-based antioxidant lycopene, tomatoes are being engineered to contain the antioxidant-rich purple pigment from blueberries.

And people in developing countries faced with famine and malnutrition are likely to benefit from attempts to improve the protein content of food crops, as well as the amount of vitamins and minerals they provide.

This is not to say that everything done in the name of genetic engineering has a clean bill of health. Controversy abounds over the use of genetically modified seeds that produce crops like soy, corn, canola, alfalfa, cotton and sorghum that are resistant to a widely used herbicide, glyphosate, the health effects of which are still unclear.

In the latest development, resistance to a second weed killer, 2,4-D, has been combined with glyphosate resistance. Although the combination product, called Enlist Duo, was approved in 2014 by the Environmental Protection Agency, 2,4-D has been linked to an increase in non-Hodgkin’s lymphoma and a number of neurological disorders, researchers reported in the International Journal of Environmental Research and Public Health.


GMO Safety and Regulations

Calls for increased regulation do not account for the robust review already in place. The safety of GM food and crops is not in question in the scientific community. The current regulatory program ensures their safety both in the farm field and for consumers.

• Every major scientific body in the U.S. and around the world has reviewed independent research related to GM crops and food and has concluded they are as safe as food and crops developed from other methods in use today.
• New non-genetically engineered (GE) foods and crops are continually being added to the marketplace. None of these non-GE crops undergo safety testing and review prior to commercialization even though the potential exists for changes that could be harmful, while GE crops and foods must meet rigorous standards of safety.
• GM crops and foods are regulated at every stage of production from research planning through field-testing, food and environmental safety assessment, and after commercial use.
• GM crops and foods have been in use in the U.S. for 30 years with no evidence, despite allegations, that they cause any harm.
• GM foods contain the same nutritional attributes as like foods produced with non-GM crops (although some may contain added nutritional benefits, such as vitamin enhancements). Any GM food with significantly lower nutritional attributes would be rejected in the regulatory process
• In decades of testing in the lab and in field trials, a transferred gene has never been known to produce a new allergen, toxin or anything functionally different from what was expected.

From Medicine to Food—Scientists Affirm the Safety of GM Technology

Since the initial development of genetic engineering more than three decades ago, there has been no scientific support for the perception among some consumers that GMOs are harmful. While no agricultural or food production method can be entirely free from risk, genetic modification (GM) is on par for safety as compared to other production methods.

Genetic engineering (GE), also called recombinant DNA (rDNA), is the underlying technology giving rise to Genetically Modified Organisms (GMOs). This process was first developed in the 1970s and used to make the first commercial GM product, human insulin, in the early 1980s. From the beginning, scientists questioned whether the GM process would result in hazardous substances. Several independent government studies in the 1980s concluded that the process of genetic engineering was not inherently hazardous (NAS, OECD).

Subsequently, additional professional scientific and medical organizations worldwide have conducted follow-up studies and reviews of existing studies as GM products have become more prevalent, not only in foods but also in medicines and industrial products, such as biofuels and detergents. All of these independent scientific analyses (British Royal Society, French Academies, etc.) support the original conclusions. Since the time that GM products were first commercialized in the 1980s, and despite allegations by some that they might pose health hazards, not a single case of harm can be attributed to GM technology. (NAS, 2004, AAAS, 2012)

In considering GMO safety, it’s critical to differentiate between a specific GMO and the category consisting of all GMOs. A specific GMO could be a particular variety of corn or soybean that might conceivably produce a substance in the grain (e.g., an allergen) that could pose a health threat to a small subset of the population. In contrast, a categorical hazard—the production of a hypothetical harmful substance from all organisms undergoing the GM process—would arise from any GMO, not just certain specific ones.

We know that categorical hazards do not exist. Scientists have been studying a wide range of GMOs since the 1970s and have not identified any categorical hazards. If there is a hazard with a given GMO, it is limited to that specific GMO and not the entire spectrum of GMOs. This is why regulatory agencies review specific GMOs on a case-by-case basis. It is also why FDA and USDA decline food labels based on the process of genetic engineering, because of the process of how a food is irrelevant to food safety or nutrition.

Testing Is Extensive Prior to Commercial Release of a new GMO

When a GMO is being developed, a gene of interest (a piece of DNA carrying the genetic recipe for a specific protein imparting the desired trait) is inserted into the genome of the host species, usually in a crop such as corn or soybeans. There are several technical methods of inserting a new piece of DNA into the DNA genome, with the two most common being Agrobacterium and biolistic (aka “gene gun”).

Agrobacterium tumefaciens is a common bacterium and a naturally occurring genetic engineer. In nature, the bacteria live in soil and have the ability to transfer a portion of its bacterial DNA to a plant and have it inserted into the plant’s DNA, making the bacterial DNA a permanent part of the plant’s genome (i.e., the total complement of DNA of that plant). The genes carried on the bacterial DNA are “read” and “expressed” by the plant cell, resulting in the production of proteins new to the plant but beneficial to the Agrobacterium. In making GM crops, scientists trick the Agrobacterium by deleting its own bacterial genes and substituting genes of interest, that is, those genes creating a desired trait in the plant. The Agrobacterium, now carrying the genes of interest, naturally transfers those useful genes to plant cells in petri dishes, and the useful genes are naturally inserted into the plant genome and become a permanent part of the plant’s genetic makeup.

The other method, using the biolistic ‘gene gun’, involves taking many copies of the gene of interest and coating them on tiny shotgun pellets, which are literally shot with a blast of air into the target plant cells in a petri dish. Again, the genes of interest are inserted into the genome of the plant cell and become a permanent part of the plant’s genome.

In both cases, the engineering adds one or two additional genes to the 30,000 or so genes (depending on the species) already present in the genome. It’s important to remember that the basic plant remains the same as before genetic engineering merely adds a useful gene (or sometimes deletes a deleterious gene) to the complement of genes already present in the genome. Here’s an illustrative analogy: inserting a desirable gene into a plant genome is like adding a useful app to your smartphone the new app takes up a small bit of space and (usually) doesn’t interfere with the other apps already present, but performs useful functions when called upon to do so.

Early testing of transformed (genetically engineered) cells takes place in the lab, while the recipient or host plant cells are still growing in petri dishes. Various tests are conducted to ensure that the cells have indeed taken up the transferred DNA and those successfully “transformed” cells are nurtured and grown into whole plants, which will flower and set seed, just as traditional plants of the same species. These seeds and their progeny are tested for many features, including food and environmental safety as well as the new trait of interest.

In addition to assuring that the DNA is successfully integrated into the host plant genome, tests assure that the inserted gene is actively “read” or “expressed” and that the appropriate protein is produced from the transferred gene recipe. In practice, a transferred gene either successfully produces the appropriate protein, or if unsuccessful, fails to produce anything functional.

Crucially, a transferred gene has never been known to produce a new allergen, toxin or anything functionally different from what was expected.

Years of Rigorous Testing Ensure GM Safety

Progeny testing continues into confined growth cabinets and, if all is well, then in greenhouses. At each generation, the testing becomes more elaborate. Any transgenic ‘event’ (the regulatory term for a single genetically transformed cell grown out into a whole plant, and all subsequent generations derived from the initial transformed cell) is tested and, if failing any test, the entire event line (i.e., all the plants derived from the initial transformed cell) is culled.

Most event lines are culled due to features of the inserted gene, such as genetic instability, where the transferred gene is not permanently fixed in place in the host genome, or if the gene is not expressed sufficiently to produce enough protein to confer the desired trait. Other reasons for culling include changes from the original cultivar (a plant or group of plants selected for desirable characteristics) features, such as poor agronomic performance (especially decreased yield or delayed ripening), weak plants, or poor quality or nutritional results such as lower vitamin content than the parent variety grown under the same conditions.

By the time the transgenic plants graduate from confined indoor trials to reach open field trials, as regulated by the U.S. Department of Agriculture, there is already a huge collection of data relating to safety, stability and expression of the new trait. In field trials, the performance is compared with other plants of the same species to ensure the agronomic performance is at least as good as the parent. Such field trials are also grown in different regions where the commercial cultivars are grown to collect data on regional performance. Other tests assure the expression of the new trait functions sufficiently under field-grown conditions, because those are the conditions under which farmers will be growing them.

These tests can take several years to complete, and only then, if all the results are satisfactory, will the GM plant be considered for regulatory approval and eventual commercialization.


How does the Plant Biotechnology Consultation Program work?

The Plant Biotechnology Consultation Program is a voluntary program with four key steps:

  • GMO plant developer meets with FDA about a potential new product for use in human and animal food.
  • GMO developer submits food safety assessment data and information to FDA.
  • FDA evaluates the data and information and resolves any issues with the developer.
  • Consultation is complete once FDA has no more questions about the safety of the human and animal food made from the new GMO plant variety. Completed consultations are all made public.

The Program allows FDA to work with crop developers to help create a safe food supply. It also allows FDA to collect information about new foods. See a full list of GMOs that have gone through the Plant Biotechnology Consultation Program.


What about animals that eat food made from GMO crops?

More than 95% of animals used for meat and dairy in the United States eat GMO crops. Independent studies show that there is no difference in how GMO and non-GMO foods affect the health and safety of animals. The DNA in the GMO food does not transfer to the animal that eats it. This means that animals that eat GMO food do not turn into GMOs. If it did, an animal would have the DNA of any food it ate, GMO or not. In other words, cows do not become the grass they eat and chickens don’t become the corn they eat.

Similarly, the DNA from GMO animal food does not make it into the meat, eggs, or milk from the animal. Research shows that foods like eggs, dairy products, and meat that come from animals that eat GMO food are equal in nutritional value, safety, and quality to foods made from animals that eat only non-GMO food.


Outlook on the World Market for Food Safety Testing 2019-2024: Focus on Testing for Pathogens, Pesticides, GMOs, and More

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The report analyzes the market for Food Safety Testing Services by the following Testing Types and End-Use Segments:

The report profiles 84 companies including many key and niche players such as:

  • Food Safety Testing Service Providers
  • ALS Limited (Australia)
  • Bureau Veritas S.A. (France)
  • DTS Food Laboratories (Australia)
  • Charles River Laboratories International, Inc. (USA)
  • Covance, Inc. (USA)
  • Eurofins Scientific (Luxembourg)
  • Genetic ID NA, Inc. (USA)
  • ifp Institut fr Produktqualitt GmbH (Germany)
  • International Laboratory Services (UK)
  • Intertek Group PLC (UK)
  • Mrieux NutriSciences (USA)
  • Microbac Laboratories, Inc. (USA)
  • Neogen Corporation (USA)
  • Romer Labs, Inc. (USA)
  • SGS SA (Switzerland)
  • Food Safety Testing Product Companies
  • 3M Company (USA)
  • bioMrieux SA (France)
  • Biolog, Inc. (USA)
  • Charm Sciences, Inc. (USA)
  • FOSS A/S (Denmark)
  • Hygiena, LLC (USA)
  • R-Biopharm AG (Germany)
  • Thermo Fisher Scientific, Inc. (USA)

Key Topics Covered

1. INDUSTRY OVERVIEW
Food Safety Emerges as a Major Concern for Public Health Systems
Increasing Focus on Safe and High-Quality Foods Propels Food Safety Testing Market
A Bird's Eye View of Food Testing Market
Growing Need to Curb Foodborne Illnesses Drives Food Safety Testing Market
Developed Economies Lead the Food Safety Testing Market
Asia-Pacific Spearheads Growth in the Food Safety Testing Market
Pathogen Testing
The Largest Food Testing Type
Comparison of Foodborne Pathogen Testing Methods
E.coli Testing Market: Technology Advancements Drive Growth
MIT Researchers Develop New Technology to Test Presence of E.coli Strain in Foods
GMO Testing: The Fastest Growing Testing Category
Pesticide Residue Testing Market Rides on the Growing Need to Limit Pesticide Remnants in the Food Supply Chain
Meat Industry
The Largest End-Use Segment
Highly Regulated Food & Beverage Industry Presents Opportunities for Testing Market
FSMA Implementation Pushes Demand for Technologies Enabling Traceability
Globalization Injects Universal Demand for Food Diagnostics
Increase in Number and Complexity of Foodborne Outbreaks and Product Recalls
Food Safety Testing Market Positioned for Growth
A Glance at Select Product Recalls in the US
2018
List of Foodborne Illness Outbreaks in the US (2013-2017)
Rapid Screening Gains Preference over Traditional Food Testing Procedures
Traditional Testing Technologies Continue to Rule the Roost
Leading Food Processors Resort to Rapid Microbiological Testing
Competitive Landscape
Food Safety Diagnostic Companies Facing Testing Times

2. MARKET TRENDS AND ISSUES
Rising Food Needs of an Expanding Global Population Turn Focus onto Food Safety
Food Contract Laboratories to Outdo In-house Labs
Outsourcing of Food Safety Testing Gathers Steam
List of Food Testing Laboratory Types
Food Microbiology Testing Market on a Growth Spree
Rapid and Automated Tests: Attractive Solution for Food Processors
Non-O157 STEC Pathogens: Focus of Testing Companies
Food Safety Market Being Transformed by Emerging Technologies
Next-Generation Sequencing (NGS)
Blockchain Technology
Industrial Internet of Things (IIoT)
NGS-based Food Safety Testing: A Technology with High-Growth Promise
Novel & Tested Technologies to Spur Growth
Nanotechnology in Food Testing
Biosensors and Smartphones Set New Frontiers
Biotechnology and Bioinformatics
The Backbone of New Testing Technologies
SERS Technique
An Alternative to PFGE
Process Testing to Gain Prominence
Automation Picks Up Momentum
Smart Labels and Tags Gains Significance
Consumer Packaged Goods Companies: Technology Innovations Aid in Compliance with Food Safety Requirements
Adulteration of Meat Products on the Rise
Meat Irradiation: A Solution to Curb Contamination?
Poultry Industry Embraces Rapid Microbiological Testing Technologies
Mycotoxin: A High-Grade Food Contaminant
List of Common Mycotoxins and its Effect on Health
Food Safety Services Challenged by Emerging Raw Materials
Environmental Monitoring Gaining Prominence in Food Processing Environment
Mandatory Labeling Requirements Bode Well for Food Safety Testing Market
Key Issues
Food Diagnostics
The Legislative Perspective
Food Industry's Growing Threat: Genetically Modified Organisms (GMOs)
Food Safety Issues in Food Production
List of Food Safety Related Issues in Different Stages of Food Production
Global Companies Resist Standardization of Testing Procedures
Technical and Cost Related Hurdles Hamper the Microbiology Testing Market
Test Kits Remain Insufficient for Detecting All Allergens
Available Test Kits at External Laboratories by Allergen
Ban on Antibiotics Fuel Food Residue Testing
Herbicide Resistant Genetically Engineered Plants Pose Problem

3. AN INSIGHT INTO FOOD SAFETY TESTING MARKET BY TECHNOLOGY
Real-time PCR/qPCR Technologies Fundamental in Food Safety Testing
Growing Prominence of Immunoassays in Food Sciences and Quality Control
Growing Concerns over GMOs Demand Rapid Tests for GMOs Detection
Status of Ban on GMO Corps in Select Countries
PCR Technique Plays a Vital Role in GMOs Detection
ELISA and Lateral Flow Tests Adoption in Identification of GMOs to Zoom
Metabolomic Profiling in Food Safety Testing: An Opportunity to Tap
Multiplexing
A New Trend for Food Pathogen Testing
LC/MS Technologies Gains Space in Food Safety Testing
Prospects for Molecular Diagnostics in Food Safety Testing Grow Brighter

4. REGULATORY ENVIRONMENT
Stringent Norms Necessitate Food Safety Testing
Growing Need for Standardization of Pesticide Residue Testing
Food Safety Modernization Act (FSMA)
HACCP
Advantages of HACCP
Codex Alimentarius Commission Agreement for Pre-Market GMO Testing
Europe Enforces Regulatory Framework for Food Contact Materials
European Union Policy on Genetically Modified
Stringent Directives
Regulation (EC) 1829/2003 on Genetically Modified Organisms
Changing Regulatory Policies
Impact on Market Players

5. AN INSIGHT INTO FOOD SAFETY
Introduction
Common Causes of Food Contamination
Top Ten Pathogens Attributed to Food Borne Diseases
An Overview of Select Pathogens
Campylobacter
E.coli O157:H7
Salmonella
Listeria
Other Pathogenic Forms
Removing Food Contaminants
Food Irradiation
Ultra-High Pressure Technology
Ozone Treatment
Steam Pasteurization
Fumigation
Food Coating Technology

6. FOOD SAFETY TESTING: PRODUCT OVERVIEW
What is Food Safety Testing?
Pathogen Testing
Pesticide Testing
GMO Testing
Food Safety Testing
A Comprehensive Overview
Microbiological Tests
Pathogen Testing
Simple, Efficient and Fast Testing
Nucleic Acid Analysis
Rapid Hygiene Testing
Keeping the Surrounding Clean: Rapid Hygiene Testing
Pesticide Testing
GMO Testing
Understanding the GMO Testing Process
Product Sampling
DNA Extraction
PCR Amplification
Testing Methods
Regulating GMO Testing
Surface Hygiene Testing
Swab'N'Check Hygiene Monitoring Kit
Swabbing by Australian Standard Method
3M Petrifilm
Oxoid Dip Slides
BAX System
Other Related Testing Technologies
Immunoassay Technology
Magnetic Particle Assays
Lateral Flow Immunoassay Strips
Coated-Tube Immunoassays
Microtiter Plate Assays
Bioluminescence Technology
Role of High Pressure Processing in Ensuring Food Safety
How does HPP Work?
Applications

7. END-USE MARKET ANALYSIS
Processed Foods
Fruit & Vegetable Juices
Alternative Beverages: Key Competitors
Fortified Drinks: The Latest in' Fad
100% Juices are in Vogue
Meat Industry
Processed Meat & Fast Foods
Replacing Traditional Meals
Why is Meat Processed?
Dairy Products
Emerging Markets Offer Opportunities
Churning Out New Opportunities

8. PRODUCT INNOVATIONS/INTRODUCTIONS
Bureau Veritas and Schutter Launch On-site Aflatoxin Test
CERTUS Unveils CERTUS System for In-house Rapid Pathogen Detection
Neogen Announces Availability of NeoSeek Genomic Testing Services
Neogen Introduces New Mycotoxin Tests
Neogen Introduces Veratox for Sesame Allergen Test
Neogen Introduces New Food Safety Testing Products
Neogen Introduces New Drug Residue Testing Products
Romer Labs Introduces AgraStrip Soy Test Kit
Neogen Unveils Four New Products for Drug Residue Testing

9. RECENT INDUSTRY ACTIVITY
Eurofins and Orion Partner for Expanding Auditing an Certification Services in Canada
Eurofins Acquires Craft Technologies
Eurofins Takes Over Food Analytica
HRL and MilkTestNZ Agree to Provide Analytical Testing Services to New Zealand Dairy Industry
SGS Takes Over Vanguard Sciences
Mrieux Acquires Stake in Tecnimicro Laboratorio de Analisis
Align Capital Partners Acquires Barrow-Agee
Eurofins Acquires Institut Nehring
ALS Takes Over Mikrolab Group
CERTUS to Distribute Solus Pathogen Testing System in the US
3M Takes Over Elution Technologies
Global ID Group Takes Over Analitus Anlises Biotecnolgicas
Mrieux NutriSciences Acquires Bangalore Testing Laboratories
ALS Takes Over Marshfield Food Safety
ALS Arabia and Biyaq Laboratories Form JV
Eurofins Takes Over Gzlem Gda Kontrol ve Aratrma Laboratuvarlar
Mrieux NutriSciences Takes Over ACM Agro
Hygiena Concludes Take Over of DuPont Diagnostics
Microbac Laboratories Enters into Partnership with Sample6
NSF Takes Over G+S Laboratory
Merck Takes Over BioControl Systems
Hygiena Acquires Pruebas Microbiologicas Rapidas
Eurofins Takes Over International Laboratory Services
SGS Establishes New Food and Agriculture Testing Lab in Korea
SGS Takes Over Stake in Biopremier
Eurofins Scientific Acquires Bureau de Wit
Eurofins Scientific Acquires Agro-Analyses
Bureau Veritas Acquires Majority Stake in DTS
FOSS and Mrieux NutriSciences Enter into Strategic Partnership
Mrieux NutriSciences Expands Operations in South America
Eurofins Scientific to Acquire Exova's Food, Water and Pharmaceutical Products Testing
Thermo Fisher Receives Extended AOAC-RI Performance Tested Methods Certification for SureTect
NSF Acquires Euro Consultants Group

10. FOCUS ON SELECT PLAYERS

11. GLOBAL MARKET PERSPECTIVE

Total Companies Profiled: 84 (including Divisions/Subsidiaries 100)

  • The United States (60)
  • Canada (1)
  • Japan (1)
  • Europe (26)
  • Asia-Pacific (Excluding Japan) (11)
  • Middle East (1)

For more information about this report visit https://www.researchandmarkets.com/r/yf04zb

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.


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Should the research survive scientific scrutiny -- a serious hurdle -- it could prove a game changer in many fields. It would mean that we're eating not just vitamins, protein, and fuel, but gene regulators as well.

That knowledge could deepen our understanding of many fields, including cross-species communication, co-evolution, and predator-prey relationships. It could illuminate new mechanisms for some metabolic disorders and perhaps explain how some herbal and modern medicines function.

This study had nothing to do with genetically modified (GM) food, but it could have implications on that front. The work shows a pathway by which new food products, such as GM foods, could influence human health in previously unanticipated ways.

Monsanto's website states, "There is no need for, or value in testing the safety of GM foods in humans." This viewpoint, while good for business, is built on an understanding of genetics circa 1960. It follows what's called the "Central Dogma" of genetics, which postulates a one-way chain of command between DNA and the cells DNA governs.

The Central Dogma resembles the process of ordering a pizza. The DNA codes for the kind of pizza it wants, and orders it. The RNA is the order slip, which communicates the specifics of that pizza to the cook. The finished and delivered pizza is analogous to the protein that DNA codes for.

We've known for decades that the Central Dogma, though basically correct, is overly simplistic. For example: MiRNAs that don't code for anything, pizza or otherwise, travel within cells silencing genes that are being expressed. So while one piece of DNA is ordering a pizza, it could also be bombarding the pizzeria with RNA signals that can cancel the delivery of other pizzas ordered by other bits of DNA.

Researchers have been using this phenomena to their advantage in the form of small, engineered RNA strands that are virtually identical to miRNA. In a technique called RNA interference, or RNA knockdown, these small bits of RNA are used to turn off, or "knock down," certain genes.

RNA knockdown was first used commercially in 1994 to create the Flavor Savr, a tomato with increased shelf life. In 2007, several research teams began reporting success at engineering plant RNA to kill insect predators, by knocking down certain genes. As reported in MIT's Technology Review on November 5, 2007, researchers in China used RNA knockdown to make:

. cotton plants that silence a gene that allows cotton bollworms to process the toxin gossypol, which occurs naturally in cotton. Bollworms that eat the genetically engineered cotton can't make their toxin-processing proteins, and they die.

Researchers at Monsanto and Devgen, a Belgian company, made corn plants that silence a gene essential for energy production in corn rootworms ingestion wipes out the worms within 12 days.

Humans and insects have a lot in common, genetically. If miRNA can in fact survive the gut then it's entirely possible that miRNA intended to influence insect gene regulation could also affect humans.

Monsanto's claim that human toxicology tests are unwarranted is based on the doctrine of "substantial equivalence." According to substantial equivalence, comparisons between GM and non-GM crops need only investigate the end products of DNA expression. New DNA is not considered a threat in any other way.

"So long as the introduced protein is determined to be safe, food from GM crops determined to be substantially equivalent is not expected to pose any health risks," reads Monsanto's website.

In other words, as long as the final product -- the pizza, as it were -- is non-toxic, the introduced DNA isn't any different and doesn't pose a problem. For what it's worth, if that principle were applied to intellectual property law, many of Monsanto's patents would probably be null and void.

Chen-Yu Zhang, the lead researcher on the Chinese RNA study, has made no comment regarding the implications of his work for the debate over the safety of GM food. Nonetheless, these discoveries help give shape to concerns about substantial equivalence that have been raised for years from within the scientific community.

In 1999, a group of scientists wrote a letter titled "Beyond Substantial Equivalence" to the prestigious journal Nature. In the letter, Erik Millstone et. al. called substantial equivalence "a pseudo-scientific concept" that is "inherently anti-scientific because it was created primarily to provide an excuse for not requiring biochemical or toxicological tests."

To these charges, Monsanto responded: "The concept of substantial equivalence was elaborated by international scientific and regulatory experts convened by the Organization for Economic Co-operation and Development (OECD) in 1991, well before any biotechnology products were ready for market."

This response is less a rebuttal than a testimonial to Monsanto's prowess at handling regulatory affairs. Of course the term was established before any products were ready for the market. Doing so was a prerequisite to the global commercialization of GM crops. It created a legal framework for selling GM foods anywhere in the world that substantial equivalence was accepted. By the time substantial equivalence was adopted, Monsanto had already developed numerous GM crops and was actively grooming them for market.

The OECD's 34 member nations could be described as largely rich, white, developed, and sympathetic to big business. The group's current mission is to spread economic development to the rest of the world. And while the mission has yet to be accomplished, OECD has helped Monsanto spread substantial equivalence globally.

Many GM fans will point out that if we do toxicity tests on GM foods, we should also have to do toxicity testing on every other kind of food in the world.

But we've already done the testing on the existing plants. We tested them the hard way, by eating strange things and dying, or almost dying, over thousands of years. That's how we've figured out which plants are poisonous. And over the course of each of our lifetimes we've learned which foods we're allergic to.

All of the non-GM breeds and hybrid species that we eat have been shaped by the genetic variability offered by parents whose genes were similar enough that they could mate, graft, or test tube baby their way to an offspring that resembled them.

A tomato with fish genes? Not so much. That, to me, is a new plant and it should be tested. We shouldn't have to figure out if it's poisonous or allergenic the old fashioned way, especially in light of how new-fangled the science is.

It's time to re-write the rules to acknowledge how much more complicated genetic systems are than the legal regulations -- and the corporations that have written them -- give credit.

Monsanto isn't doing itself any PR favors by claiming "no need for, or value in testing the safety of GM foods in humans." Admittedly, such testing can be difficult to construct -- who really wants to volunteer to eat a bunch of GM corn just to see what happens? At the same time, if companies like Monsanto want to use processes like RNA interference to make plants that can kill insects via genetic pathways that might resemble our own, some kind of testing has to happen.

A good place to start would be the testing of introduced DNA for other effects -- miRNA-mediated or otherwise -- beyond the specific proteins they code for. But the status quo, according to Monsanto's website, is:

There is no need to test the safety of DNA introduced into GM crops. DNA (and resulting RNA) is present in almost all foods. DNA is non-toxic and the presence of DNA, in and of itself, presents no hazard.

Given what we know, that stance is arrogant. Time will tell if it's reckless.

There are computational methods of investigating whether unintended RNAs are likely to be knocking down any human genes. But thanks to this position, the best we can do is hope they're using them. Given it's opposition to the labeling of GM foods as well, it seems clear that Monsanto wants you to close your eyes, open your mouth, and swallow.

It's time for Monsanto to acknowledge that there's more to DNA than the proteins it codes for -- even if it's for no other reason than the fact that RNA alone is a lot more complicated that Watson and Crick could ever have imagined.

Image: Dirk Ercken/Shutterstock.

The current version of this article originally appeared on AlterNet.


Biotechnology FAQs

Agricultural biotechnology is a range of tools, including traditional breeding techniques, that alter living organisms, or parts of organisms, to make or modify products improve plants or animals or develop microorganisms for specific agricultural uses. Modern biotechnology today includes the tools of genetic engineering.

2. How is Agricultural Biotechnology being used?

Biotechnology provides farmers with tools that can make production cheaper and more manageable. For example, some biotechnology crops can be engineered to tolerate specific herbicides, which make weed control simpler and more efficient. Other crops have been engineered to be resistant to specific plant diseases and insect pests, which can make pest control more reliable and effective, and/or can decrease the use of synthetic pesticides. These crop production options can help countries keep pace with demands for food while reducing production costs. A number of biotechnology-derived crops that have been deregulated by the USDA and reviewed for food safety by the Food and Drug Administration (FDA) and/or the Environmental Protection Agency (EPA) have been adopted by growers.

Many other types of crops are now in the research and development stages. While it is not possible to know exactly which will come to fruition, certainly biotechnology will have highly varied uses for agriculture in the future. Advances in biotechnology may provide consumers with foods that are nutritionally-enriched or longer-lasting, or that contain lower levels of certain naturally occurring toxicants present in some food plants. Developers are using biotechnology to try to reduce saturated fats in cooking oils, reduce allergens in foods, and increase disease-fighting nutrients in foods. They are also researching ways to use genetically engineered crops in the production of new medicines, which may lead to a new plant-made pharmaceutical industry that could reduce the costs of production using a sustainable resource.

Genetically engineered plants are also being developed for a purpose known as phytoremediation in which the plants detoxify pollutants in the soil or absorb and accumulate polluting substances out of the soil so that the plants may be harvested and disposed of safely. In either case the result is improved soil quality at a polluted site. Biotechnology may also be used to conserve natural resources, enable animals to more effectively use nutrients present in feed, decrease nutrient runoff into rivers and bays, and help meet the increasing world food and land demands. Researchers are at work to produce hardier crops that will flourish in even the harshest environments and that will require less fuel, labor, fertilizer, and water, helping to decrease the pressures on land and wildlife habitats.

In addition to genetically engineered crops, biotechnology has helped make other improvements in agriculture not involving plants. Examples of such advances include making antibiotic production more efficient through microbial fermentation and producing new animal vaccines through genetic engineering for diseases such as foot and mouth disease and rabies.

3. What are the benefits of Agricultural Biotechnology?

The application of biotechnology in agriculture has resulted in benefits to farmers, producers, and consumers. Biotechnology has helped to make both insect pest control and weed management safer and easier while safeguarding crops against disease.

For example, genetically engineered insect-resistant cotton has allowed for a significant reduction in the use of persistent, synthetic pesticides that may contaminate groundwater and the environment.

In terms of improved weed control, herbicide-tolerant soybeans, cotton, and corn enable the use of reduced-risk herbicides that break down more quickly in soil and are non-toxic to wildlife and humans. Herbicide-tolerant crops are particularly compatible with no-till or reduced tillage agriculture systems that help preserve topsoil from erosion.

Agricultural biotechnology has been used to protect crops from devastating diseases. The papaya ringspot virus threatened to derail the Hawaiian papaya industry until papayas resistant to the disease were developed through genetic engineering. This saved the U.S. papaya industry. Research on potatoes, squash, tomatoes, and other crops continues in a similar manner to provide resistance to viral diseases that otherwise are very difficult to control.

Biotech crops can make farming more profitable by increasing crop quality and may in some cases increase yields. The use of some of these crops can simplify work and improve safety for farmers. This allows farmers to spend less of their time managing their crops and more time on other profitable activities.

Biotech crops may provide enhanced quality traits such as increased levels of beta-carotene in rice to aid in reducing vitamin A deficiencies and improved oil compositions in canola, soybean, and corn. Crops with the ability to grow in salty soils or better withstand drought conditions are also in the works and the first such products are just entering the marketplace. Such innovations may be increasingly important in adapting to or in some cases helping to mitigate the effects of climate change.

The tools of agricultural biotechnology have been invaluable for researchers in helping to understand the basic biology of living organisms. For example, scientists have identified the complete genetic structure of several strains of Listeria and Campylobacter, the bacteria often responsible for major outbreaks of food-borne illness in people. This genetic information is providing a wealth of opportunities that help researchers improve the safety of our food supply. The tools of biotechnology have "unlocked doors" and are also helping in the development of improved animal and plant varieties, both those produced by conventional means as well as those produced through genetic engineering.

4. What are the safety considerations with Agricultural Biotechnology?

Breeders have been evaluating new products developed through agricultural biotechnology for centuries. In addition to these efforts, the United States Department of Agriculture (USDA), the Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA) work to ensure that crops produced through genetic engineering for commercial use are properly tested and studied to make sure they pose no significant risk to consumers or the environment.

Crops produced through genetic engineering are the only ones formally reviewed to assess the potential for transfer of novel traits to wild relatives. When new traits are genetically engineered into a crop, the new plants are evaluated to ensure that they do not have characteristics of weeds. Where biotech crops are grown in proximity to related plants, the potential for the two plants to exchange traits via pollen must be evaluated before release. Crop plants of all kinds can exchange traits with their close wild relatives (which may be weeds or wildflowers) when they are in proximity. In the case of biotech-derived crops, the EPA and USDA perform risk assessments to evaluate this possibility and minimize potential harmful consequences, if any.

Other potential risks considered in the assessment of genetically engineered organisms include any environmental effects on birds, mammals, insects, worms, and other organisms, especially in the case of insect or disease resistance traits. This is why the USDA's Animal and Plant Health Inspection Service (APHIS) and the EPA review any environmental impacts of such pest-resistant biotechnology derived crops prior to approval of field-testing and commercial release. Testing on many types of organisms such as honeybees, other beneficial insects, earthworms, and fish is performed to ensure that there are no unintended consequences associated with these crops.

With respect to food safety, when new traits introduced to biotech-derived plants are examined by the EPA and the FDA, the proteins produced by these traits are studied for their potential toxicity and potential to cause an allergic response. Tests designed to examine the heat and digestive stability of these proteins, as well as their similarity to known allergenic proteins, are completed prior to entry into the food or feed supply. To put these considerations in perspective, it is useful to note that while the particular biotech traits being used are often new to crops in that they often do not come from plants (many are from bacteria and viruses), the same basic types of traits often can be found naturally in most plants. These basic traits, like insect and disease resistance, have allowed plants to survive and evolve over time.

5. How widely used are biotechnology crops?

According to the USDA's National Agricultural Statistics Service (NASS), biotechnology plantings as a percentage of total crop plantings in the United States in 2012 were about 88 percent for corn, 94 percent for cotton, and 93 percent for soybeans. NASS conducts an agricultural survey in all states in June of each year. The report issued from the survey contains a section specific to the major biotechnology derived field crops and provides additional detail on biotechnology plantings. The most recent report may be viewed at the following website: https://www.ers.usda.gov/data-products/adoption-of-genetically-engineered-crops-in-the-us.aspx

The USDA does not maintain data on international usage of genetically engineered crops. The independent International Service for the Acquisition of Agri-biotech Applications (ISAAA), a not-for-profit organization, estimates that the global area of biotech crops for 2012 was 170.3 million hectares, grown by 17.3 million farmers in 28 countries, with an average annual growth in area cultivated of around 6 percent. More than 90 percent of farmers growing biotech crops are resource-poor farmers in developing countries. ISAAA reports various statistics on the global adoption and plantings of biotechnology derived crops. The ISAAA website is https://www.isaaa.org

6. What are the roles of government in agricultural biotechnology?

Please note: These descriptions are not a complete or thorough review of all the activities of these agencies with respect to agricultural biotechnology and are intended as general introductory materials only. For additional information please see the relevant agency websites.

The Federal Government developed a Coordinated Framework for the Regulation of Biotechnology in 1986 to provide for the regulatory oversight of organisms derived through genetic engineering. The three principal agencies that have provided primary guidance to the experimental testing, approval, and eventual commercial release of these organisms to date are the USDA's Animal and Plant Health Inspection Service (APHIS), the Environmental Protection Agency (EPA), and the Department of Health and Human Services' Food and Drug Administration (FDA). The approach taken in the Coordinated Framework is grounded in the judgment of the National Academy of Sciences that the potential risks associated with these organisms fall into the same general categories as those created by traditionally bred organisms.

Products are regulated according to their intended use, with some products being regulated under more than one agency. All government regulatory agencies have a responsibility to ensure that the implementation of regulatory decisions, including approval of field tests and eventual deregulation of approved biotech crops, does not adversely impact human health or the environment.

The Animal and Plant Health Inspection Service (APHIS) is responsible for protecting U.S. agriculture from pests and diseases. APHIS regulations provide procedures for obtaining a permit or for providing notification prior to "introducing" (the act of introducing includes any movement into or through the U.S., or release into the environment outside an area of physical confinement) a regulated article in the U.S. Regulated articles are organisms and products altered or produced through genetic engineering that are plant pests or for which there is reason to believe are plant pests.

The regulations also provide for a petition process for the determination of non-regulated status. Once a determination of non-regulated status has been made, the organism (and its offspring) no longer requires APHIS review for movement or release in the U.S.

For more information on the regulatory responsibilities of the FDA, the EPA and APHIS please see:

Market Facilitation

The USDA also helps industry respond to consumer demands in the United States and overseas by supporting the marketing of a wide range of agricultural products produced through conventional, organic, and genetically engineered means.

The Agricultural Marketing Service (AMS) and the Grain Inspection, Packers, and Stockyards Administration (GIPSA) have developed a number of services to facilitate the strategic marketing of conventional and genetically engineered foods, fibers, grains, and oilseeds in both domestic and international markets. GIPSA provides these services for the bulk grain and oilseed markets while AMS provides the services for food commodities such as fruits and vegetables, as well as for fiber commodities.

These services include:

1. Evaluation of Test Kits: AMS and GIPSA evaluate commercially available test kits designed to detect the presence of specific proteins in genetically engineered agricultural commodities. The agencies confirm whether the tests operate in accordance with manufacturers' claims and, if the kits operate as stated, the results are made available to the public on their respective websites.

GIPSA evaluates the performance of laboratories conducting DNA-based tests to detect genetically engineered grains and oilseeds, provides participants with their individual results, and posts a summary report on the GIPSA website. AMS is developing a similar program that can evaluate and verify the capabilities of independent laboratories to screen other products for the presence of genetically engineered material.

2. Identity Preservation/Process Verification Services: AMS and GIPSA offer auditing services to certify the use of written quality practices and/or production processes by producers who differentiate their commodities using identity preservation, testing, and product branding.

Additional AMS Services: AMS provides fee-based DNA and protein testing services for food and fiber products, and its Plant Variety Protection Office offers intellectual property rights protection for new genetically engineered seed varieties through the issuance of Certificates of Protection.

Additional GIPSA Services: GIPSA provides marketing documents pertaining to whether there are genetically engineered varieties of certain bulk commodities in commercial production in the United States. USDA also works to improve and expand market access for U.S. agricultural products, including those produced through genetic engineering.

The Foreign Agricultural Service (FAS) supports or administers numerous education, outreach, and exchange programs designed to improve the understanding and acceptance of genetically engineered agricultural products worldwide

1. Market Access Program and Foreign Market Development Program: Supports U.S. farm producer groups (called "Cooperators") to market agricultural products overseas, including those produced using genetic engineering.

2. Emerging Markets Program: Supports technical assistance activities to promote exports of U.S. agricultural commodities and products to emerging markets, including those produced using genetic engineering. Activities to support science-based decision-making are also undertaken. Such activities have included food safety training in Mexico, a biotechnology course for emerging market participants at Michigan State University, farmer-to-farmer workshops in the Philippines and Honduras, high-level policy discussions within the Asia-Pacific Economic Cooperation group, as well as numerous study tours and workshops involving journalists, regulators, and policy-makers.

3. Cochran Fellowship Program: Supports short-term training in biotechnology and genetic engineering. Since the program was created in 1984, the Cochran Fellowship Program has provided education and training to 325 international participants, primarily regulators, policy makers, and scientists.

4. Borlaug Fellowship Program: Supports collaborative research in new technologies, including biotechnology and genetic engineering. Since the program was established in 2004, the Borlaug Fellowship Program has funded 193 fellowships in this research area.

5. Technical Assistance for Specialty Crops (TASC): Supports technical assistance activities that address sanitary, phytosanitary, and technical barriers that prohibit or threaten the export of U.S. specialty crops. This program has supported activities on biotech papaya.

USDA researchers seek to solve major agricultural problems and to better understand the basic biology of agriculture. Researchers may use biotechnology to conduct research more efficiently and to discover things that may not be possible by more conventional means. This includes introducing new or improved traits in plants, animals, and microorganisms and creating new biotechnology-based products such as more effective diagnostic tests, improved vaccines, and better antibiotics. Any USDA research involving the development of new biotechnology products includes biosafety analysis.

USDA scientists are also improving biotechnology tools for ever safer, more effective use of biotechnology by all researchers. For example, better models are being developed to evaluate genetically engineered organisms and to reduce allergens in foods.

USDA researchers monitor for potential environmental problems such as insect pests becoming resistant to Bt, a substance that certain crops, such as corn and cotton, have been genetically engineered to produce to protect against insect damage. In addition, in partnership with the Agricultural Research Service (ARS) and the Forest Service, the Cooperative States Research, the National Institute of Food and Agriculture (NIFA) administers the Biotechnology Risk Assessment Research Grants Program (BRAG) which develops science-based information regarding the safety of introducing genetically engineered plants, animals, and microorganisms. Lists of biotechnology research projects can be found at https://www.ars.usda.gov/research/projects.htm for ARS and at https://www.nifa.usda.gov/funding-opportunity/biotechnology-risk-assessment-research-grants-program-brag for NIFA.

USDA also develops and supports centralized websites that provide access to genetic resources and genomic information about agricultural species. Making these databases easily accessible is crucial for researchers around the world.

USDA's National Institute of Food and Agriculture (NIFA) provides funding and program leadership for extramural research, higher education, and extension activities in food and agricultural biotechnology. NIFA administers and manages funds for biotechnology through a variety of competitive and cooperative grants programs. The National Research Initiative (NRI) Competitive Grants Program, the largest NIFA competitive program, supports basic and applied research projects and integrated research, education, and/or extension projects, many of which use or develop biotechnology tools, approaches, and products. The Small Business Innovation Research Program (SBIR) funds competitive grants to support research by qualified small businesses on advanced concepts related to scientific problems and opportunities in agriculture, including development of biotechnology-derived products. NIFA also supports research involving biotechnology and biotechnology-derived products through cooperative funding programs in conjunction with state agricultural experiment stations at land-grant universities. NIFA partners with other federal agencies through interagency competitive grant programs to fund agricultural and food research that uses or develops biotechnology and biotechnology tools such as metabolic engineering, microbial genome sequencing, and maize genome sequencing.

USDA's Economic Research Service (ERS) conducts research on the economic aspects of the use of genetically engineered organisms, including the rate of and reasons for adoption of biotechnology by farmers. ERS also addresses economic issues related to the marketing, labeling, and trading of biotechnology-derived products.


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