Biotechcpe Slide Presentation

8/4/2019 Biotechcpe Slide Presentation

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Food Biotechnology 101:

A Primer on the Science

& the Public Debate

The genetic enhancement of plants has been an ongoing science since prehistorictimes, when early farmers began carefully selecting and maintaining seed from

their best crops to plant for the next season.

With the advent of recombinant DNA (rDNA) technology in the 1970s, the genetic

enhancement of plants or plant biotechnology entered a new age. Crop traitimprovements previously unavailable through traditional breeding becameavailable. Even in situations where traditional breeding had been possible,

modern biotechnology offered more specific plant breeding options. Productsof modern biotechnology are now on the market in the United States and 20

other countries around the world. Examples include corn, soybean, canola,cotton, and papaya with improved agronomic traits.

Consensus in the scientific community is that foods produced through

biotechnology are as safe as conventional counterparts. Benefits areincreasingly well-documented. Still, biotechnology is controversial for some. Asolid grounding in the science is essential for the dietetic professional who

seeks to help the public sift through information provided on television, inmagazines, and on the Internet.


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F o o d B i o t e c h n o l o g y

The Role for the Dietetic Professional

American Dietetic Association Position (2006)

agricultural and food biotechnology techniques canenhance the quality, safety, nutritional value, andvariety of food available for human consumption andincrease the efficiency of food production, foodprocessing, food distribution, and environmental andwaste management. The ADA encourages thegovernment, food manufacturers, food commoditygroups, and qualified food and nutrition professionalsto work together to inform consumers about this new

technology and encourage availability of theseproducts in the marketplace.

Dietetic professionals can play a pivotal role in helping American consumersunderstand how biotechnology helps bring healthful foods to market. About half(53%) of consumers say that dietitians are among the most credible andtrusted sources for information related to food biotechnology.

While a majority of American consumers continue to be open to food biotechnology,there remains some confusion or lack of information about its role. Research

shows that nearly three quarters of Americans have heard something aboutbiotechnology, but only about one out of ten have heard a lot. In addition, justunder one-third of consumers say they have heard nothing aboutbiotechnology. Dietetic professionals can help translate the science andeducate consumers about the facts related to food biotechnology.

The American Dietetic Association developed a position paper encouragingdietitians to become well-versed in biotechnology. The ADAs position paper(2006) asserts agricultural and food biotechnology techniques can enhancethe quality, safety, nutritional value, and variety of food available for humanconsumption and increase the efficiency of food production, food processing,food distribution, and environmental and waste management. The ADAencourages the government, food manufacturers, food commodity groups, andqualified food and nutrition professionals to work together to inform consumers

about this new technology and encourage availability of these products in themarketplace.

The full position paper is available on ADAs Web site (www.eatright.org).


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Food Biotechnology Defined

Fermentation (e.g.,yeast used in brewingor bread-making)

Tissue culture (eg,plant propagation)

Cross breeding (eg,broccoflower)

Genetic transfer (e.g.,rDNA technology)

Biotechnologyrefers to various techniques used inagriculture and food production to provide better agricultural

conditions and better food:

Biotechnologyrefers to various techniques used in agriculture and food productionto provide better agricultural conditions and better food:

Fermentation is a process in which an organism causes an organic substance tobreak down into simpler substances, especially the anaerobic breakdown ofsugar into alcohol. Yeast used in brewing or bread-making are examples offermentation.

Tissue culture is a process of growing a plant from cells rather than seeds. It issimilar to techniques familiar to home gardeners, such as budding and grafting,and is used in traditional plant breeding as well as modern agriculturalbiotechnology. The new plants that result will be identical to the parent plant.

Biotechnology has also made possible selective cross breeding, or the mixing ofdifferent varieties of plants or species of animals in order to produce a planthybrid with specific desirable traits. The process mixes thousands of genes inorder to transfer the one or few desirable genes for specific traits in the finalproduct. Broccoflower is an example of cross breeding and has some of thecharacteristics of broccoli and some of the characteristics of cauliflower (seeimage on slide: cauliflower on the left, broccoli on the right, and broccoflower inthe middle).

It is important to note that all of these techniques, and even cross-pollination thatoccurs in the wild and in traditional breeding, allow the genetic modification of

plants or animals. Therefore, nearly all foods that we consume are geneticallymodified.

Within the last 30 years, scientists have developed the techniques of geneticengineering, which is the focus of this continuing education module.


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Modern food biotechnology, or

genetic engineering, allows for

the identification and transfer

of one or more specific

gene(s), creating desired

qualities in a plant, and

offering a more precise way to

produce plants with certain

beneficial characteristics

such as insect protection orbetter nutrition.

Food Biotechnology Defined

Modern foodbiotechnology, also known as genetic engineering or recombinant DNA

(rDNA) technology, allows for the identification and transfer of one or more specificgene(s), creating desired qualities in a plant and offering a more precise way toproduce plants with certain beneficial characteristicssuch as insect protection or

better nutrition.

The slide graphic shows a simplified distinction between traditional breeding (top), where

many genes are transferred to the target plant variety, versus genetic engineering(bottom), in which specific genes are isolated and transferred.


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Food Biotechnology: A brief history

13000-8000 BC Domestication of wild plants6000-4000 BC Fermentation (wine, beer, bread)2500 BC Domestication of wild animals1800s Pasteurization

Laws of Heredity proposed1930s Hybrid seed corn introduced1950s DNA structure described1970s Gene transferred between organisms1980s Human insulin, developed with

biotechnology, approved by FDA

Understanding the history of food production and processing helps to elucidate the evolutionof biotechnology and its role in modern food production.

Food biotechnology has been evolving for centuries.

Around 10,000-15,000 years ago humans started to domesticate wild plants to producethe crops we have today. They were able to do this because plants genetically modifythemselves often at quite high rates, but in random ways. The crops we grow would nothave occurred in nature; rather, humans directed their evolution. These crops often donot resemble their wild ancestors and can no longer live in the wild.

In 2500 BC, Egyptians were breeding geese to make them bigger and better tasting whencooked.

Documentation of fermentation in food production dates back to 6000 BC.

Foundations for food biotechnology, including pasteurization, advances in understandingheredity and genetics, and hybrid corn production (or crossbreeding), were laid in in the1800s and early 1900s.

Modern food biotechnology dates back to 1972 when genes were transferred betweenorganisms for the first time by researchers Stanley Cohen and Herbert Boyer. Working tohelp people living with diabetes, they lifted genetic material from one organism's DNA andcopied it into another organisms DNA. It was the beginning of the story of insulin.

In 1982 human insulin was developed with biotechnology. Insulin for treatment ofdiabetes was originally obtained from the pancreas of pigs and cows. In 1982, Boyerisolated a gene for insulin production from human DNA. He then inserted it into bacteria,which allowed the gene to reproduce a larger quantity of insulin for diabetics. Thisscientific advancement vastly improved the availability and purity of insulin for peopleliving with diabetes.

In 1990 the cheese-making process was improved through biotechnology. Researchersremoved a rennet-producing gene from calves stomachs and reproduced it in bacteria.The biotechnology-produced enzyme, chymosin, eliminated the need for rennin fromcalves stomachs for the production of cheese. Also, researchers in the United Kingdomdeveloped a yeast that sped up the leavening process by rearranging and duplicatingcertain yeast genes.


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Food Biotechnology: A brief history, continued

1990s First food products enhancedusing modern biotechnologyintroduced chymosin forcheese making; improved yeastfor bread making 1990s

Multiple product introductions:extended freshness tomato, insect-protected potato, corn, & cotton, virus-resistant squash & papaya, herbicide-tolerant soybean

1998 Biotech helps save Hawaiianpapaya industry from devastation

2002 Rice genome described

2005 8.5 million farmers (90% indeveloping nations) planted

biotech crops in 21 countries

In 1994 the Flavr Savr tomato was the first wholefood produced using modern

biotechnology to be approved for sale in the U.S. It was developed to have less waterand therefore better firmness than a conventional tomato. Unfortunately, it suffered in

the marketplace because harvesting machines at the time damaged the soft, alreadyripened fruit, which made delivery of the Flavr Savr to retail difficult.

An herbicide-tolerant variety of soybean was introduced in 1997; As of 2005, this cropwas the most cultivated biotechnology crop in the United States.

In 1998, the Hawaiian papaya industry was revived from devastation with agenetically-enhanced virus-resistant variety. Papaya ring spot virus (PRSV), a

devastating and hard to control disease, infected the Hawaiian papaya crop. Scientistsused genetic engineering to develop a PRSV-resistant papaya (similar to how

vaccines are used for humans). Papaya production rebounded significantly.

Other crop introductions in the 1990s included insect-protected potato, corn, andcotton, and virus-resistant squash.

April 2002, the genome of the rice plant was described. With the mapping of the

worlds most widely used grain, scientists expect to be able to identify the genesresponsible for disease and drought resistance in the rice plant and help protect this

staple for the worlds growing population.

In 2005, the tenth year of biotech crop cultivation, 8.5 million farmers (90% of whomlive and work in developing nations) planted biotech crops in 21 countries.


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Modern Biotechnology Techniques

Gene TransferParticle gun

Agrobacterium tumefaciens

Plant Tissue Culture

Testing & Evaluation

The techniques used to accomplish gene insertion (gene transfer) in plants are welldefined. Scientists use either a natural genetic engineer called Agrobacteriumtumefaciens, or a particle gun.

Plant tissue culture is then used to produce plant tissue that is transformed,meaning that it expresses the transferred trait.

Finally, after seeds are produced from the biotech plants, greenhouse and field trials

must be conducted.

The following slides explain more about these approaches.


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Methods of Gene Transfer: Agrobacteriumtumefaciens

A. tumefaciens +

rDNA plasmid

Plasmid

PlasmidDNA

Openplasmid

DesiredDNA

New DNA(rDNA)

Plant cell + new

gene

+

+

Flask ofplant cells

Plants withnew gene

Currently, the most widely used method for transferring genes into plants is using the

Agrobacterium-mediated transformation. Agrobacterium tumefaciensis a common,naturally occurring bacterium in the soil that has the ability to transfer its DNA into a

plant's genome. Scientists have taken advantage of this naturally occurring transfermechanism to help carry desired genes into a plants genome. A. tumefacienscontains a small circle of free-floating DNA called a plasmid. This plasmid is usedas a carrier of the new gene with the desired trait that scientists wish to transfer into

the target plant.First, scientists identify and remove the gene that controls the desired trait from one

plant using special enzymes that act like scissors. Next, they remove the plasmidfrom A. tumefaciensand snip out a part of the DNA in the plasmid that acts as the

natural genetic engineer. This creates an open circle of DNA (open plasmid).This open plasmid is mixed with the desired DNA and pasted together using

special enzymes, producing recombinant DNA (rDNA) that contains the desiredgene.

The rDNA is combined with A. tumefaciens, and this culture is then mixed with targetplant tissue. Some of the target plant cells incorporate the desired gene into theirown DNA.

This transformed plant tissue is then regenerated into a mature plant through tissue

culture techniques, described in slide 11.


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Methods of Gene Transfer: Particle Gun

Pellets coatedwith DNA

Plant chromosome

Geneinsertion

New plant cellwith gene

Another genetic engineering method uses a particle gun to transfer desirable traits.

Scientists isolate the desired gene or genes from one plant. The DNA is mixedwith microscopic metal (either gold or tungsten) pellets. These DNA-coated

pellets are then forced through the plant cell walls using a blast of helium gas.Some of the pellets enter the plant cells, allowing the cells to incorporate thedesired DNA into the plants chromosome material.

The transformed plant tissue is then regenerated into a mature plant through tissue

culture techniques, described in slide 11.


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Plant Tissue Culture

These new plant cells, whether produced through the Agrobacteriumor particle gun

methods, are screened for successful transfer of the desired trait. The successfulevents are then cultured, as in traditional breeding, to form plants that are grown

first in greenhouses and then in field trials.

The ideal genetically engineered plant will have all the desirable traits of the parentplant, such as high yield, as well as consistent and effective expression of theinserted trait, such as pest protection.


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Testing & Evaluation

Initial testing evaluates:Safety of introduced gene product

Stable inheritance of gene

Unintended effects on growth, yield, quality

Greenhouse & Field TrialsMultiple locations during multi-year process

Testing for:

Agronomic performance (market question,not regulatory requirement)

Environmental effectsFood safety

Plants produced through biotechnology are evaluated for:

Safety of introduced gene product

Stable inheritance of the gene

Unintended effects on growth, yield, quality

Laboratory analysis is followed by greenhouse testing and field trials prior to commercialization. This is amulti-location, multi-year process that test for:

Agronomic performance (market question, not regulatory requirement)

Environmental effects

Food safety

The regulatory oversight of these processes is discussed in a later slide.


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Why Use Modern Biotechnology?Improve Human Health

Promote human health Insulin - A familiar example in the medical field

Reduced exposure of farmers to pesticides

Reduced mycotoxins in insect-resistant corn

High oleic acid soybeans

Modern biotechnology can be used for various reasons. As various applications are discussed,note which ones are in foods on the market today, versus those that have been developedor are in development, but not yet commercialized:

Promote human health:

The first biotechnology products were medicines designed to address human diseases. Afamiliar example is insulin, used to treat diabetics, as well as blood clot-busting enzymes

for heart attack victims. These and other medicines are now produced easily and morecheaply as a result of biotechnology.

While technology and stringent regulations in U.S. help farmers to avoid overexposure topesticides, farmers in certain other regions of the world use more pesticides and applythem to crops in an unsafe manner. Therefore, the adoption of biotech crops in these worldregions, which is leading to reduced pesticide use, is reducing farmer exposure topesticides. Pesticide exposure poisoning is down 75% in China among farmers who plantbiotech cotton, for example.

Another example is the reduction in mycotoxin formation in insect-resistant (Bt) corn.Mycotoxins are substances produced by fungi that can cause health problems in animalsand humans, such as esophageal cancer at high concentrations and neural tube defects ateven low concentrations. Damage to growing corn caused by insect pests like the cornborer allow spores from the fungi to enter the kernel tissue, where they producemycotoxins. Research shows that minimizing insect damage through pest control methods,like Btcorn, can reduce the incidence of fungal infection and accumulation of mycotoxins.

And high oleic acid soybeans have been developed, although they are not currently growncommercially.


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Why Use Modern Biotechnology?Protect Crops & Environment

Plant disease protectionVirus-resistant papaya

Virus-resistant squash

Environmentally sustainable farmingReduce use of insecticides (Bt cotton/Bt corn)

Protection of

soil and water

Decreased

fossil fuel use

Plant disease protection: Many indigenous fruit and vegetable crops are afflicted with viral diseases

for which there is no known remedy. Virus resistance is a type of genetic enhancement that canhelp prevent these plant diseases, ensuring a healthy and abundant supply to meet consumersongoing demands. The Hawaiian papaya crop is one example in which genetically enhancedpapaya were bred to resist the papaya ring spot virus (PRSV). Biotechnology was important to

papaya because it was the only other option for controlling PRSV was to destroy the papayatrees. Virus-resistant squash is also grown commercially on small acreage in the U.S.

Environmentally sustainable farming: Through biotechnology, greater possibilities exist to decrease

the impact of farming on the environment. Biotechnology can help reduce farmers reliance oninsecticides and help them to use herbicides more effectively. Biotech crops with built-in

protection from harmful insects (Btcorn, Btcotton) allow for reduced use of insecticides. Forexample, Btcotton represents 50% of the cotton acreage in China, resulting in a 50-80%decrease in pesticide usage.

Biotechnology also provides opportunities to decrease soil erosion, water pollution, and fossil fuel

emissions. Herbicide-tolerant crops require less tilling of the soil, preserving topsoil, reducingrunoff into streams and rivers, and preserving wildlife habitats. Reduced soil tillage and reducedpesticide use allow farmers to pass over the fields in tractors less frequently, which helpsconserve fossil fuels.


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Why Use Modern Biotechnology?Improve Food and Feed Quality

Improved food qualityDelayed ripening Improved taste Improved food processing attributes

Improved feed supplyReduced mycotoxin risk in BtcornReduced weed content in

herbicide-tolerant cropsused for feed(improved nutrient density)

In addition, crops can be developed with improved taste and quality.

Delay ripening: Biotechnology can be used to slow down ripening through reduced ethylenesynthesis, which allows fruits and vegetables to remain fresh longer.

Improve taste: Through delayed ripening, biotechnology may help to improve the taste of somefoods. For example, delayed ripening enables tomatoes to stay on the vine longer anddevelop full flavor instead of being picked green.

Improve food processing techniques: Oilseed fatty composition is being enhanced, some for

nutritional enhancements, and others for improved functionality and stability in foodprocessing. In addition, some crops are genetically enhanced for improved solids contentfor stability and texture.

And finally, animal feed has also been improved both in terms of safety and quality

Reduced mycotoxin content in Btcorn is already a reality.

Reduced weed content has also been realized in herbicide-tolerant soybeans, which translatesinto improved nutrient density of the feed stock. And research is underway to provide thisbenefit through herbicide tolerant alfalfa, as well.


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Biotech Food Crops Currently Available

Food crops:

Corn

Soybean

Cotton

Canola

Papaya

Squash

Examples of food ingredients available through biotech:

Corn, soybean, canola, and cottonseed oils; corn meal, syrup,and starch; soy protein, flour, and lecithin

Components used in food production: Chymosin in cheese and yeast in bread production

Some of the food crops available today that have been enhanced throughbiotechnology are:

Corn

Soybean

Cotton

Canola

Papaya

Squash

Examples of food ingredients available through biotech:

Corn, soybean, canola, and cottonseed oils; corn meal, syrup, and starch; soyprotein, flour, and lecithin

Components used in food production:

Chymosin in cheese and yeast in bread production


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Biotech Products: Potential for Future

In Development:

Nutritional improvements (in development) Oils aimed at improving fatty acid profile of finished

food products Golden Rice (beta carotene and iron content and

bioavailability enhanced)

Early Stages of Research:

Reduced allergenicity

Drought tolerance/ Improved water utilization

Improved feed supply

Accelerated food production

Plant-based vaccines

Simpler and faster pathogen detection

Biotechnology has been used in a number of crops for several years, and more genetically enhancedproducts are expected to be on the market in the coming years. Applications that may develop in thenear future include:

Applications that are currently in development include:

Nutritional improvements: Over the past several decades, a number of oilseeds have been introduced withmodified fatty acid compositions. The current emphasis on transfat reduction in foods withoutcompromising taste has accelerated development of new ingredients that can be used as transfat-replacers in a variety of applications. Low-linolenic acid canola, sunflower, and soybean oils arecurrently available through traditional breeding. They are more stable in processing, so can be used toproduce foods with lower trans fat content, without raising saturated fat levels. Down the road, geneticengineering may lead to oils that can be used as ingredients in foods with lower saturated fat, and evenhigher omega-3 fatty acid content.

Boosting nutritional content is particularly useful In developing nations where nutrient deficiencies are moreprominent than in Western countries. An example is Golden Rice which is enhanced with vitamin A.Vitamin A deficiency (VAD) is a public health problem in 118 countries, especially in Africa andSoutheast Asia. VAD contributes to about 2 million deaths annually, and it is a leading cause ofpreventable blindness in children. The latest developments have increased beta carotene content 20-fold over the original Golden Rice variety to provide 50 percent RDA for vitamin A.

Reduced allergenicity in foods: Scientists may be able to switch off or dim the intensity of allergens infoods. Research into the very complex process of reducing the allergenicity of foods such as soybeans,rice, peanuts, and wheat is underway. There are difficulties in maintaining agronomic performance withsuch modifications, however the health implications of such advancements, if successful, could besignificant.

Drought tolerance/ Improved water utilization: Through advancements in biotechnology, plants may one day

be able to grow in tough conditions, like heat and drought, which will be of most benefit to farmers indeveloping nations.

Improved feed supply: Research is underway to improve the feed available to farm animals. A herbicide-tolerant alfalfa exposes farm animals to fewer weeds, and more alfalfa, thus a more nutritious diet.

Accelerated food production: World fisheries are currently over fished. Fish is an important food for manypopulations, thus production must improve. A company in Massachusetts is researching ways to bringAtlantic salmon to market size in half the time by making metabolism and maturation of the salmonmore efficient.

Plant-based vaccines: Research is underway to use staple foods to deliver inexpensive, effective vaccinesfor specific illnesses. These edible vaccines could save approximately 15 million children who die eachyear from preventable diseases. A dried tomato powder is being developed to deliver hepatitis Bvaccine when consumed, which would cost less and would be more easily administered be eliminatingthe need for refrigeration or injections, both important considerations in developing nations.

Pathogen detection: Biotech is providing simpler and faster methods to locate pathogens, toxins, andcontaminants to reduce risk of foodborne illness .


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Questions & Issues

Coexistence with organic agricultureSafeguards to prevent unwanted cross-pollination

and adventitious presence

Room for each method in sustainable ag production

Long-term safety

Scientific consensus supports safety

Critics call for longer time frame

Allergenicity

Potential to increase risksafeguards in place

Potential to decrease risk is the subject of research

Labeling

Mandatory vs. voluntary

Process vs. end-product-based

While biotechnology is being used in agriculture and food production in order to bring about the benefits outlined in theprevious slides, some continue to question the value of the technology. Some questions are being addressed throughscientific inquiry, while others tap into social, ethical, political, and economic considerations.

Coexistence with organic agriculture

Coexistence refers to the ability of farmers to produce crops in a way that does not infringe upon neighboringagricultural practices. Pollen flows from one field to the next, pesticides sprayed on one field may be blown by the windto the neighboring field. After harvest, plant material or seeds from several different fields may be mixed together at agrain elevator or in a shipping or storage facility (inadvertent post harvest presence of an unwanted crop variety is

sometimes referred to as adventitious presence). Some growers of organic and conventional crops fear economic losses in non-biotech markets if biotech components

are present in the seed supply, in the field, or in harvested products.

Safeguards are in place, such as farmers ensuring that adequate planting distances are maintained to reduce thelikelihood of unwanted cross-pollination.

Long-term safety

Scientific consensus supports the safety of foods produced through biotechnology

Critics call for longer time frame to be studied before drawing conclusions about safety.

Discussion of several expert reviews of research regarding the safety of biotech foods is included in the followingslides.

Allergenicity

The safety discussions in the following slides will also address allergenicity concerns.

Some argue that food biotechnology has the potential to increase the risk of food allergic reactions. Safeguardsagainst this potential risk include avoiding transferring genes from the most commonly allergenic foods, including fish,shellfish, eggs, milk, soy, wheat, peanuts, and tree nuts. Use of genetic material from these sources would require

extensive testing to prove the absence of allergenicity Current research is exploring the possibility of decreasing risk of food allergic reactions by decreasing or even

eliminating allergenic protein expression in a food. Soybeans, rice, peanuts, and wheat are the subjects of currentresearch.

Labeling

Controversy regarding labeling centers around whether foods should be labeled based on how they were produced,versus the safety profile of the end product.

The FDA has issued draft guidance to industry for the voluntary labeling of foods that have been or have not beenproduced through biotechnology, however critics call for mandatory, process-based labeling.

The issue of labeling will also be discussed at length in the following slides.


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Consensus on Safety

Food biotechnology is the most extensivelyreviewed agricultural advancements to date

After 10 years of biotech products in the foodsupply, there hasn't been a single confirmedadverse experience attributable to acommercialized biotech product.

Food biotechnology is the most extensively reviewed agricultural advancements and foodproduction techniques to date.

After 10 yrs of biotech products in the food supply, there has not been a single, confirmed

adverse experience attributable to a biotech product.


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Consensus on Safety: Resources

Regulatory authorities in 21 countries, including:

Argentina, Australia, Brazil, Canada, Columbia, China,Czech Republic, European Union, France, Germany,Honduras, India, Iran, Mexico, Paraguay, the Philippines,Portugal, Romania, South Africa, Spain, United States ofAmerica, Uruguay

European Commission

Institute of Medicine and National Research Council, Academiesof Sciences (NAS)

American Dietetic Association (ADA)

American Medical Association (AMA)

Institute of Food Technologists (IFT)

Society of Toxicology

Several scientific and governmental bodies endorse the use and safety of food biotechnologytechniques for agriculture and food production. Regulatory authorities in the U.S. (USDA,FDA, and EPA) and abroad, and the broad scientific community agree that foods producedusing biotechnology are as safe as comparable conventional or organic varieties. Foodsproduced through either biotechnology or conventional breeding methods must all meet thesame high safety standards. The FDA has authority to remove foods deemed to be unsafefrom the market.

Crops developed through biotechnology have been approved by regulatory authorities and aregrown on farms in 21 countries throughout the world, including Argentina, Australia, Brazil,Canada, Columbia, China, Czech Republic, European Union, France, Germany, Honduras,

India, Iran, Mexico, Paraguay, the Philippines, Portugal, Romania, South Africa, Spain,United States of America, Uruguay.

In October 2001, the European Commission released a report reviewing data on 81 projectsand 15 years of research. The report concluded that foods derived from biotechnology aresafer than conventional counterparts because biotechnology is more precise andundergoes greater regulatory scrutiny.

The Institute of Medicine and National Research Council of The National Academy ofSciences, in a 2004 report commissioned by USDA, FDA, and EPA, provided a thoroughreview of the safety of the process of genetic engineering, compared to other forms ofgenetic modification, or breeding. The conclusion that genetic engineering is no more orless likely to produce unintended effects helps to address the concern of some that notenough is known about the technology (ie, long-term safety).

A number of other health and food organizations also support the responsible use of foodbiotechnology. These include the American Dietetic Association (2006), the AmericanMedical Association (2000) and the Institute of Food Technologists (2000).

Additionally, after a comprehensive review of the science in 2002, the Society of Toxicology

concluded that foods produced through biotechnology are as safe as traditional foods.Since its birth in January 2000, more than 3,200 renowned scientists, including 19 Nobel Prize

laureates, signed a declaration endorsing food biotechnology as a safe, environmentally-friendly, and useful tool to help feed the developing world.


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Biotechnology Safety and Regulation: FDA

Regulates testing for Nutritional value Allergenicity Toxicity New uses

Requires full food safety evaluation in

certain cases: Genes not already in the food supply Significantly different nutrient, allergen, or

toxin levels

Significantly different composition New antibiotic-resistance markers

Regulates labeling if needed

In 1992, the FDA issued a statement deeming that foods derived from new plant varieties produced through

biotechnology would be regulated in the same fashion as those created through traditional means. Therefore, allnew foodsproduced through conventional means or through biotechnologywould be regulated under theFederal Food, Drug and Cosmetic Act (FFDCA). Under the FFDCA, products are evaluated for their individual

nutritional value, allergenicity, toxicity, and new uses, rather than the methods or techniques used to produce thefoods.

The FDA requires a full food safety evaluation for all food products containing (compared to edible varieties of thesame species):

Genes not already in the food supply

Significantly different nutrient, allergen, or toxin levels

Significantly different composition

New antibiotic-resistance markers

In 2001, FDA proposed a required mandatory 120-day premarket notification to FDA for new agriculturalbiotechnology products, and the provision of specific research data to support safety of the food and substantial

equivalence to its conventional counterparts. This process is now voluntary. FDA has the right to remove any foodfrom the market if there is a reasonable possibility that it is unsafe for consumption.

When developing plants through biotechnology, scientists use selectable marker genes to determine whether gene

transfer has been successful, and have in the past used antibiotic proteins. The FDA has reviewed the use ofselectable marker genes, and confirmed the safety of antibiotic-resistance marker genes and their rare use in

biotechnology.

The FDA also regulates labeling, which is discussed in detail in slides 24-26.


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Biotechnology Safety and Regulation: USDA

Biotechnology Regulatory Services(BRS), Animal and Plant HealthInspection Service (USDA-APHIS)Regulates movement, importation, and

field testing

Ensures that plants produced throughbiotechnology do not pose a pest ordisease risk to other agricultural productsor the environment

Within USDA, the primary agency for biotechnology is the Animal and Plant Health Inspection Service (APHIS).

APHIS formed the Biotechnology Regulatory Service (BRS) in 2002 to integrate all units that dealt withbiotechnology regulation, which includes oversight of the movement, importation, and field testing of agriculturalbiotechnology products. These are activities that largely apply to products that are being tested prior to

commercialization in order to ensure that the plants do not pose a pest risk to other agricultural products or theenvironment.

This was originally accomplished through the issuance of permits. The Notification and Petition Processes wereimplemented and expanded in 1993 and 1997, based on history of safety in field trials and scientific review.

Under the Notification Process, permits are no longer required for most field tests of corn, soybeans, cotton,tobacco, potatoes, or tomatoes. Instead, BRS can be notified of a field test using a simple, standardized format.

The Petition Process was initiated to provide a mechanism by which biotech plants that have been field tested

and are candidates for commercialization can acquire nonregulated status. Under this rule, anyone can requestthat BRS review a submission and issue written documentation for Determination of Non-Regulated Status to

allow for free movement and planting of certain crops. However, this is only possible when the agencydetermines the new varieties have no potential to pose a plant-pest risk and are as safe to grow (for agriculture

and the environment) as another variety of the same plant.

Since 1987, APHIS has authorized more than 10,000 field trials and has overseen the deregulation of more

than 60 biotech products (40% enhanced for herbicide tolerance and 25% for insect protection), although notall of these varieties are in commercial production.

An important group that cannot be considered under notification are plants that have been modified to producepharmaceutical or industrial (non-food) products. These products are till regulated through the permit process.


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Biotechnology Safety and Regulation: EPA

Regulates testing of pest-protectedvarieties for:Toxicology and allergenicity

Long term human health impact

Effects on nontarget organisms

Environmental fate

Potential for pest resistance

EPA is charged with the regulation of pesticides, the setting of environmental tolerances for pesticides, and theestablishment of exemptions for pesticide residues in and on crops. The EPA also has jurisdiction over new

insect-protected and herbicide-tolerant biotechnology crops under the Federal Insecticide, Fungicide andRodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA).

Environmental exposure to pesticide substances produced in biotechnology crops is regulated by EPA to ensurethat there are no adverse effects on the environment, including any beneficial, nontargeted organisms. Specificpesticides requiring review by the EPA include pesticides not derived from a known food source; any pesticides

consumed in a different way; or pesticides that have a different structure, function, or composition.

TSCA states that the EPA must review and approve every applicable new chemical product before it is

manufactured for commercial purposes. FIFRA controls the registration (and re-registration), manufacture, anduse of any pesticides, including those produced using biotechnology. Review and approval of applications forgenetically enhanced pesticides or crop plants containing pesticidal properties must be conducted by EPA

officials, prior to any field testing.

In 1996, EPA approved the use of Bacillus thuringiensis(Bt) in corn. Btis a naturally occurring bacterium present

in soil and known for its ability to control pests. Although harmless to most insects, people, birds, and other

animals, Btproduces a protein that disrupts the digestive system of target insects.

Following a nearly two-year review process, the EPA announced In October of 2001 that Btdoes not pose

unreasonable risks to human health or to the environment and approved the use of all Btcorn products foranother seven years.

EPAs regulations are focused on the pesticide produced by the plant, rather than on the plant as a whole. Theagency does require developers of new plant pesticides to obtain acreage-dependent experimental use permits

from EPA. Plants containing pesticides must also be registered with EPA prior to being sold or distributed.


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FDA Food Labeling Regulations

Objectives of all food labeling:Protect against misleading statements or

claimsProvide nutrition and safety information Inform public of potential health risks

Product-based, not process-based

The FDA labeling policy for foods produced through biotechnology isconsistent with regulations and standards for all foods:

The objectives of all food labeling are to:

protect against misleading statements or claims

provide nutrition and safety information inform public of potential health risks

The labeling regulation is based on the characteristics of the food itself and not

the method used to produce it. Therefore, FDA does not require speciallabeling of foods because the food or one of its ingredients was derived frombiotechnology.

It is important to note that some states have considered legislation related to

biotechnology that is inconsistent with the federal approach to regulate based

on the end product, notthe process.


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FDA Food Labeling Regulations

A label is required if there is the presence of an allergen an increase in naturally occurring toxins a change in nutrient composition or profile a change in use or handling

Draft guidelines to industry for voluntary labelingof foods produced with or without biotechnologyissued in 2001

A label is required with

the introduction of an allergen or

an increase in naturally occurring toxins or

substantially different nutritional content (such as increased vitamin or reduced fatcontent) or if there was a change in identity so that traditional names no longer apply(as with the traditional breeding examples of the tangelo produced from tangerine andgrapefruit, and broccoflower produced from broccoli and cauliflower) or

a change in use or handling.

In 2001 FDA also proposed draft guidelines for the voluntary labeling of foodsproduced using biotechnology. These guidelines include suggestions for terminologyas well as statements and claims regarding the presence or absence of biotechingredients that are considered to be misleading and will not be allowed on foodproducts once the guidelines are finalized.


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Food Labeling Perspectives

Argument for process-based labeling:

Consumers right to know Long term safety

A way to track in food supply

Argument for current product-based labeling policy: FDA: Labeling is not necessary if there is no evidence that

genetic engineering changes food quality, safety or any otherattribute.

NAS: Genetic engineering is no more or less likely toproduce unintended consequences compared to other formsof genetic modification, or breeding.

AMA: no scientific justification for special labeling ofgenetically modified foods as a class

More than three-fourths (82%) of consumers say noadditional information is needed on labels; 63% support theFDA labeling policy (2006)

The question of whether food that contains ingredients derived through biotechnology should

be labeled has become a source of extensive deliberation and debate.Lets take a look atboth sides:

People who are in favor of mandatory labeling say:

Many consumers may want to know, and it is their right to have access to this

information, often called consumers right to know. Because biotechnology-derived foods are relatively new in the marketplace, some people

think they should be labeled until long-term safety has been established.

And some people think labeling is the best way to track whats going on in the foodsupply in the event of any unintended consequences like allergic reactions.

In support of the current policy are the following:

The FDAs labeling policy is based on the premise that, Labeling is not necessary ifthere is no evidence that genetic engineering changes food quality, safety or any otherattribute.

A 2004 report of The National Academies stated that genetic engineering is no more or

less likely to produce unintended consequences compared to other forms of geneticmodification, or breeding. The report pointed out that a safety concern should require thata food not be allowed on the market, rather than allowed on the market with a label.

The American Medical Association agreed in a 2000 position statement that, noscientific justification for special labeling of genetically modified foods as a class

Importantly, an overwhelming majority of consumers (82%) state that there is noinformation that they would like to see added to food labels. Additionally, sixty-three

percent support the current FDA labeling policy (2006).


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US Consumer Awareness High,Knowledge Low

71% of consumers have heardor read about biotechnology Only 12% have heard a lot

26% know biotech foodsavailable in stores

As consumer opinion is often cited either in support or opposition to foodbiotechnology, lets take a closer look.

The International Food Information Council surveyed 1000 US consumersregarding food biotechnology in 2006 and found, similar to trends dating

back to 1997, that consumers have remained only vaguely aware of foodbiotechnology:

71% of consumers have heard or read about biotechnology, but only 12%have heard a lot.

And only one-quarter (26%) know that such foods are available forpurchase today.


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US Consumers Opinion:Low Concern

3% of consumers identify biotechas a food safety concern

Three percent of consumers identify biotechnology as a food safetyconcern


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US Consumers Opinion:Impact of Awareness on Attitudinal Measures

Higher awareness is positively correlatedwith knowledge, purchase intent, andexpectation of benefits

Awareness of food biotechnology seems to incline consumers to be more,not less, favorably disposed to the technology. Specifically, awareconsumers are more likely to know biotech foods are in stores today, state

likelihood to purchase foods produced through biotechnology, and expectbenefits from the technology.


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US Consumers Opinion:Purchase Intent & Expectation of Benefits

Taste Better/

Fresher

Not atall likely

Verylikely

Not toolikely

Somewhatlikely

Pesticide Reduction

Reduce Saturated

Fat Content

Provide More

Healthful Fats 15%

19%

30%

7%

7%

50%

50%

48%

46%

27%

25%

27%

17%

17%7%

7%

Consumers indicate they are likely to purchase products of foodbiotechnology, particularly if biotechnology is used to provide omega-3 fats(77%), reduce saturated fats (75%), reduce pesticides (75%) or improve

taste or freshness (63%).


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Food Biotechnology:Implications for Food Today & Tomorrow

Significant impact on todays food supplyStrong regulatory system & safety

consensus

Public debate continues

Ongoing scientific review

Dietetic professionals can be a key sourceof credible information for the public

In summary, biotechnology is a tool that is having a significant impact onagriculture and the food supply with great potential for futureadvancements.

A strong regulatory system is in place in the US, based on the broad

consensus regarding safety among the scientific community.

Despite that, the public debate continues. As with any new technology,

consumers want to know why it is being used and what it will mean for thefood they eat.

Therefore, ongoing scientific review is essential. The international scientific

community continues to assess and challenge biotechnologys role inimproving the food supply, by addressing safety concerns and seeking

solutions to agricultural, food production, and human health needs.

Dietetic professionals can play a vital role in helping to translate thescience and provide information to consumers on the facts related to food

biotechnology.


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To Learn More . . .

American Dietetic Association

www.eatright.orgCouncil for Agricultural Science and Technology

www.cast-science.org

Council for Biotechnology Information

www.whybiotech.org

Institute of Food Technologists

www.ift.org

International Food Information Council Foundation

ific.org


www.toxicology.org

US Regulatory Agencies Unified Biotechnology Web Site

http://usbiotechreg.nbii.gov

Additional information about biotechnology is available and easily accessible on several health,government, industry, and science organizations web sites:

American Dietetic Association

www.eatright.org

Council for Agricultural Science and Technology

www.cast-science.org

Council for Biotechnology Information

www.whybiotech.org

Institute of Food Technologists

www.ift.org

International Food Information Council Foundation

ific.org


www.toxicology.org

US Regulatory Agencies Unified Biotechnology Web Site

http://usbiotechreg.nbii.gov
http://www.eatright.org/http://www.cast-science.org/http://www.whybiotech.org/http://www.ift.org/http://ific.org/http://www.toxicology.org/http://usbiotechreg.nbii.gov/http://www.cast-science.org/http://usbiotechreg.nbii.gov/http://www.toxicology.org/http://ific.org/http://www.ift.org/http://www.whybiotech.org/http://www.eatright.org/

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