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Agriculture Future: Biotechnology
Humans have always relied on plants and animals for food, shelter, clothing and fuel, and for thousands of years farmers have been changing them to better meet our evolving needs. Society's demand for resources provided by plants and animals will increase as the world's population grows. The global population, which numbered approximately 1.6 billion in 1900, has surged to more than 6 billion and is expected to reach 10 billion by 2030. The United Nations Food and Agriculture Organization estimates world food production will have to double on existing farmland if it is to keep pace with the anticipated population growth.

Biotechnology can help meet the ever-increasing need by increasing yields, decreasing crop inputs such as water and fertilizer, and providing pest control methods that are more compatible with the environment.

Biotechnology can help meet the ever-increasing need by increasing yields, decreasing crop inputs such as water and fertilizer, and providing pest control methods that are more compatible with the environment

Crop Biotechnology

Farmers and plant breeders have relied for centuries on crossbreeding, hybridization and other genetic modification techniques to improve the yield and quality of food and fiber crops and to provide crops with built-in protection against insect pests, disease-causing organisms and harsh environmental conditions. Stone Age farmers Selected plants with the best characteristics and saved their seeds for the next year's crops. By Selectively sowing seeds from plants with preferred characteristics, the earliest agriculturists performed genetic modification to convert wild plants into domesticated crops long before the science of genetics was understood.

As our knowledge of plant genetics improved, we purposefully crossbred plants with desirable traits (or lacking undesirable characteristics) to produce offspring that combine the best traits of both parents. In today's world, virtually every crop plant grown commercially for food or fiber is a product of crossbreeding, hybridization or both. Unfortunately, these processes are often costly, time consuming, inefficient and subject to significant practical limitations. For example, producing corn with higher yields or natural resistance to certain insects takes dozens of generations of traditional crossbreeding, if it is possible at all.

The tools of biotechnology allow plant breeders to Select single genes that produce desired traits and move them from one plant to another. The process is far more precise and Selective than traditional breeding in which thousands of genes of unknown function are moved into our crops.

Biotechnology also removes the technical obstacles to moving genetic traits between plants and other organisms. This opens up a world of genetic traits to benefit food production. We can, for example, take a bacterium gene that yields a protein toxic to a disease-causing fungus and transfer it to a plant. The plant then produces the protein and is protected from the disease without the help of externally applied fungicides.

IMPROVING CROP PRODUCTION
The crop production and protection traits agricultural scientists are incorporating with biotechnology are the same traits they have incorporated through decades of crossbreeding and other genetic modification techniques: increased yields; resistance to diseases caused by bacteria, fungi and viruses; the ability to withstand harsh environmental conditions such as freezes and droughts; and resistance to pests such as insects, weeds and nematodes.

Natural Protection for Plants
Just as biotechnology allows us to make better use of the natural therapeutic compounds our bodies produce, it also provides us with more opportunities to partner with nature in plant agriculture.

Through science, we have discovered that plants, like animals, have built-in defense systems against insects and diseases, and we are searching for environmentally benign chemicals that trigger these natural defense mechanisms so plants can better protect themselves.

Biotechnology will also open up new avenues for working with nature by providing new biopesticides, such as microorganisms and fatty acid compounds, that are toxic to targeted crop pests but do not harm humans, animals, fish, birds or beneficial insects. Because biopesticides act in unique ways, they can control pest populations that have developed resistance to conventional pesticides.

A biopesticide farmers (including organic farmers) have used since the 1930s is the microorganism Bacillus thuringiensis, or Bt, which occurs naturally in soil. Several of the proteins the Bt bacterium produces are lethal to certain insects, such as the European corn borer, a prevalent pest that costs the United States $1.2 billion in crop damage each year. Bt bacteria used as a biopesticidal spray can eliminate target insects without relying on chemically based pesticides.

Using the flexibility provided by biotechnology, we can transplant the genetic information that makes the Bt bacterium lethal to certain insects (but not to humans, animals or other insects) into plants on which that insect feeds. The plant that once was a food source for the insect now kills it, lessening the need to spray crops with chemical pesticides to control infestations.

The plant that once was a food source for the insect now kills it, lessening the need to spray crops with chemical pesticides to control infestations.

Herbicide Tolerance
Good planting conditions for crops will also sustain weeds that can reduce crop productivity as they compete for the same nutrients the desired plant needs. To prevent this, herbicides are sprayed over crops to eliminate the undesirable weeds. Often, herbicides must be applied several times during the growing cycle, at great expense to the farmer and possible harm to the environment.

Using biotechnology, it is possible to make crop plants tolerant of specific herbicides. When the herbicide is sprayed, it will kill the weeds but have no effect on the crop plants. This lets farmers reduce the number of times herbicides have to be applied and reduces the cost of producing crops and damage to the environment.

Resistance to Environmental Stresses
In addition to the biological challenges to plant growth and development just described, crop plants must contend with abiotic stresses nature dispenses regularly: drought, cold, heat and soils that are too acidic or salty to support plant growth. While plant breeders have successfully incorporated genetic resistance to biotic stresses into many crop plants through crossbreeding, their success at creating crops resistant to abiotic stresses has been more limited, largely because few crops have close relatives with genes for resistance to these stresses.

The crossbreeding limitation posed by reproductive compatibility does not impede crop biotechnology; genes found in any organism can be used to improve crop production. As a result, scientists are making great strides in developing crops that can tolerate difficult growing conditions. For example, researchers have genetically modified tomato and canola plants that tolerate salt levels 300 percent greater than non-genetically modified varieties. Other researchers have identified many genes involved in cold, heat and drought tolerance found naturally in some plants and bacteria. Scientists in Mexico have produced maize and papaya that are tolerant to the high levels of aluminum that significantly impede crop plant productivity in many developing countries.

Increasing Yields
In addition to increasing crop productivity by using built-in protection against diseases, pests, environmental stresses and weeds to minimize losses, scientists use biotechnology to improve crop yields directly. Researchers at Japan's National Institute of Agrobiological Resources added maize photosynthesis genes to rice to increase its efficiency at converting sunlight to plant starch and increased yields by 30 percent. Other scientists are altering plant metabolism by blocking gene action in order to shunt nutrients to certain plant parts. Yields increase as starch accumulates in potato tubers and not leaves, or as oil-seed crops, such as canola, allocate most fatty acids to the seeds.

Biotechnology also allows scientists to develop crops that are better at accessing the micronutrients they need. Mexican scientists have genetically modified plants to secrete citric acid, a naturally occurring compound, from their roots. In response to the slight increase in acidity, minerals bound to soil particles, such as calcium, phosphorous and potassium, are released and made available to the plant.

Nitrogen is the critical limiting element for plant growth and, step-by-step, researchers from many scientific disciplines are teasing apart the details of the symbiotic relationship that allows nitrogen-fixing bacteria to capture atmospheric nitrogen and provide it to the plants that harbor them in root nodules.



  • Plant geneticists in Hungary and England have identified the plant gene and protein that enable the plant to establish a relationship with nitrogen-fixing bacteria in the surrounding soil.


  • Microbial geneticists at the University of Queensland have identified the bacterial gene that stimulates root nodule formation.


  • Collaboration among molecular biologists in the European Union, United States and Canada yielded the complete genome sequence of one of the nitrogen-fixing bacteria species.


  • Protein chemists have documented the precise structure of the bacterial enzyme that converts atmospheric nitrogen into a form the plant can use.

CROP BIOTECHNOLOGY IN DEVELOPING COUNTRIES
Today, 70 percent of the people on the planet grow what they eat, and, despite the remarkable successes of the Green Revolution in the 1960s, millions of them suffer from hunger and malnutrition. Continuing population growth, urbanization, poverty, inadequate food distribution systems and high food costs impede universal access to the higher yields provided by technological advances in agriculture. In addition, the crops genetically improved by plant breeders who enabled the Green Revolution were large-volume commodity crops, not crops grown solely by small-scale subsistence farmers.

For many farmers in developing countries, especially those in sub-Saharan Africa, the Green Revolution never materialized because its agricultural practices required upfront investments-irrigation systems, machinery, fuel, chemical fertilizers and pesticides-beyond the financial reach of small-scale farmers.

Today's biological agricultural revolution is knowledge intensive, not capital intensive, because its technological advances are incorporated into the crop seed.

Today's biological agricultural revolution is knowledge intensive, not capital intensive, because its technological advances are incorporated into the crop seed. As a result, small-scale farmers with limited resources should benefit. In addition, because of the remarkable flexibility provided by crop biotechnology, crop improvement through genetic modification need no longer be restricted to the large-volume commodity crops that provide a return on industrial R&D investments. A beneficial gene that is incorporated into maize or rice can also be provided to crops grown by subsistence farmers in developing countries because the requirement for plant reproductive compatibility can be circumvented.

Realizing biotechnology's extraordinary capacity for improving the health, economies and living conditions of people in developing countries, many universities, research institutions, government agencies and companies in the industrialized world have developed relationships for transferring various biotechnologies to developing countries. The nature of the relationship varies, depending on the needs and resources of the partners involved. For example:



  • Cornell University donated transgenic technology for controlling the papaya ring spot virus to research institutions in Brazil, Thailand and Venezuela and provided their scientists with training in transgenic techniques.


  • Japan's International Cooperation Agency built tissue culture facilities at an Indonesian research institution so that scientists there could develop disease-free potato materials for planting. The Indonesian researchers are also working with scientists at Michigan State University to develop insect-resistant potatoes and sweet potatoes.


  • An Australian agricultural research center collaborated with Indonesian researchers on studies of nitrogen fixation and development of disease-resistant peanuts.


  • Seiberdorf Laboratories (Austria) worked with the Kenyan Agricultural Research Institute to transfer technology for cassava mutagenesis and breeding.


  • Monsanto has donated virus resistance technologies to Kenya for sweet potatoes, Mexico for potatoes and Southeast Asia for papaya and technology for pro-vitamin A production in oilseed crops to India.


  • Pioneer Hi-Bred and the Egyptian Agricultural Genetic Engineering Research Institute (AGERI) collaborated to discover potentially novel strains of Bt in Egypt. Pioneer trained AGERI scientists in methods for characterizing Bt strains and transgenic techniques. Patents are owned by AGERI and licensed to Pioneer.


  • AstraZeneca trained scientists from Indonesia's Central Research Institute for Food Crops in the use of proprietary technologies for creating insect-resistant maize.


  • The Malaysian palm oil research institute has collaborated with Unilever and universities in England, the United States and the Netherlands on research to change the nutritional value of palm oil and find new uses for it, such as lubricants, fuels, a vitamin E precursor, natural polyester and biodegradable plastics.

While technology transfer has been and, no doubt, will continue to be an essential mechanism for sharing the benefits of crop biotechnology, many developing countries are taking the next step: investing resources to build their own capacity for biotechnology research, development and commercialization. The leaders in these countries recognize the potential of crop biotechnology to provide agricultural self-sufficiency, preserve their natural resources, lower food prices for consumers and provide income to their small farmers. Even more important, they understand that biotechnology has the potential to improve existing exports and create new ones, leading to a more diversified economy and increased independence.

But they also know that many of their agricultural problems are unique and can best be solved by local scientists who are familiar with the intricacies of the problems, local traditions, and applicability-or lack of it-of technologies that were developed to solve agricultural problems in industrialized countries. To move their countries forward, they are investing human and financial resources in developing local strength in crop biotechnology. For example:



  • The Malacca government in Malaysia formed a unit in the Chief Minister's Office to promote research and development in biotechnology and established the Sarawak Biodiversity Center to ensure sustainable use of genetic resources and to build a strong database for bioresources.


  • Taiwan opened an extension of the Hsinchu industrial park devoted exclusively to biotechnology. Companies in the park will have access to $850 million in government research and development funds and $4 billion in state and private venture capital, plus a wide range of support services including marketing and global patent applications.


  • Pakistan's Ministry of Science and Technology prepared a biotechnology action plan and funded a three-year program to promote biotechnology research and development.


  • Uganda's National Council of Science and Technology established its first commercial agricultural biotechnology lab to produce disease-free coffee and banana plantlets.


  • Egypt's government, a longtime supporter of agricultural biotechnology, released a report encouraging farmers to plant genetically modified crops to benefit from reduced pesticide applications, lower production costs, higher yields and increased income.

ENVIRONMENTAL AND ECONOMIC BENEFITS
Beyond agricultural benefits, products of crop biotechnology offer many environmental and economic benefits. As described above, biotech crops allow us to increase crop yields by providing natural mechanisms of pest control in place of chemical pesticides. These increased yields can occur without clearing additional land, which is especially important in developing countries. In addition, because biotechnology provides pest-specific control, beneficial insects that assist in pest control will not be affected, facilitating the use of integrated pest management. Herbicide-tolerant crops decrease soil erosion by permitting farmers to use conservation tillage.

Because farmers in many countries have grown biotech crops for years, data are now available for assessing the magnitude of the environmental and economic benefits provided by biotechnology. In the past few years, a number of independent researchers have produced reports documenting these benefits.

According to the National Center for Food and Agricultural Policy's (NCFAP) 2004 report, in 2003 the 11 biotech crop varieties adopted by U.S. growers increased crop yields by 5.3 billion pounds, saved growers $1.5 billion by lowering production costs, and reduced pesticide use by 46.4 million pounds. Based on increased yields and reduced production costs, growers realized a net economic impact or savings of $1.9 billion. Three new traits for corn and cotton were introduced in 2003, and the NCFAP study takes into account six biotech crops-canola, corn, cotton, papaya, soybean and squash.

In its report "Conservation Tillage and Plant Biotechnology," the Conservation Tillage Information Center (CTIC) at Purdue University attributes the recent improvements in tillage reduction to the increased use of the herbicide-tolerant varieties produced through biotechnology. CTIC concludes that the increase in conservation tillage associated with herbicide-tolerant crops decreases soil erosion by 1 billion tons of soil material per year, saves $3.5 billion per year in sedimentations costs and decreases fuel use by 3.9 gallons per acre.

According to the International Service for the Acquisition of Agri-Biotech Applications, a single biotech crop, Bt cotton, has led to the following environmental and economic benefits for farmers in developing countries:



  • From 1999 to 2000 in China, insecticide usage decreased by 67 percent and yields increased by 10 percent, leading to income gains of $500 per hectare.


  • Extensive field trials in India from 1998 to 2001 demonstrated a 50 percent reduction in insecticide spraying and a 40 percent increase in yields, which equals an increase in income from $75 to $200 per hectare.

Small farmers in South Africa gained through a 25 percent yield increase and decreased number of insecticide sprays from 11 to four, reducing pesticide costs by $45 per acre. The higher cost of Bt seed (up to $15 per hectare for small farmers) resulted in an average economic advantage of $35 per hectare.

REGULATION OF CROP BIOTECHNOLOGY
Since combining specific genes from donor and host plants does not alter the basic nature of the host plant, the result of genetic modification is predictable and can be carefully controlled. As with any new variety of food, the developers test extensively for safety, quality and other factors.

U.S. regulatory policy for biotechnology products was established in 1986 with the publication by the White House Office of Science and Technology Policy of the "Coordinated Framework." This framework builds on the work of international expert bodies (such as the Organization for Economic Cooperation and Development [OECD] and the U.S. National Academy of Sciences). The responsibilities of regulatory agencies are clarified, linked to the laws they administer and coordinated with other agencies that have potentially overlapping responsibilities.

The U.S. Food and Drug Administration (FDA) approves the safety of all foods and new food ingredients. In addition, all producers are required to ensure the safety and quality of anything they introduce into the food supply.

The FDA requires strict premarket testing and regulatory oversight of genetic modifications that significantly alter the nutritional value of the host food, use genetic material from outside the traditional food supply or use known allergens.

The FDA also requires labeling of any food product produced through biotechnology that significantly alters the host food's nutritional value or uses material from a known allergen. For example, any product that uses a gene from a peanut, which is a potential allergen, would be subject to testing and labeling requirements. The FDA also has the authority to order unsafe products off the market.

The USDA and the U.S. Environmental Protection Agency (EPA) impose safety requirements and/or performance standards on the development of pesticides, herbicides and genetically enhanced test crops. The USDA regulates to ensure that crop varieties improved through biotechnology are safe for the agricultural environment. Rigorous assessments are conducted concerning the derivation of the new varieties and their performance under contained and controlled field trials.

The EPA also coordinates with the USDA and FDA, using its own statutes to regulate the growing of plants with pest-protection characteristics. The EPA sets allowable food residue tolerance levels for any novel compounds that might be used.

Forest Biotechnology

Throughout the world, wood provides us with fuel, construction materials and paper, and its supplies are dwindling rapidly. Wood products are currently a $400 billion global industry, employing 3 million people. Demand for wood products is expected to increase, even as major economies, such as Europe and Japan, are unable to grow enough trees to meet their current demand.

INCREASING PRODUCTIVITY






We are using biotechnology to create disease- and insect-resistant trees and to increase their growth rates.

We are using biotechnology to create disease- and insect-resistant trees and to increase their growth rates. Scientists are also learning how to use biotechnology to improve the efficiency with which trees convert solar energy into plant material and to shunt more of that energy into wood production and less into pollen, flowers or seeds. All of these methods of increasing productivity should decrease the pressure on natural forests.

However, developing trees through the use of biotechnology is a lengthy undertaking because trees take a long time to grow. So, researchers are looking to other methods for increasing productivity. For example, they are using a biotechnology process in a fungus to fight diseases that infect trees and are working on improving the microorganisms that live on tree roots and provide trees with nutrients, much as nitrogen-fixing bacteria increase the nutrients available to soybeans and alfalfa. In addition, biopesticides have also been used extensively to control forest pests, and we expect progress in insect cell culture to boost the number of biocontrol agents available for forest insect control.

ENVIRONMENTAL BENEFITS
Perhaps a more important economic role for biotechnology in this industry will be found in its changing the way we convert trees to useful products. Extensive research is being conducted to increase a tree's amount of cellulose, the raw material for papermaking, and to decrease the amount of lignin, a tough molecule that must be removed in papermaking.

Traditionally, removing lignin from trees has required harsh chemicals and high energy costs, so changing the cellulose:lignin ratio genetically has important environmental implications, as does increasing the growth rate of trees. Because trees absorb carbon dioxide, any advance that allows us to increase tree yields without cutting down forest could have significant positive effects on global warming. Other environmental benefits that biotechnology is providing to the forestry industry include enzymes for



  • pretreating and softening wood chips prior to pulping.


  • removing pine pitch from pulp to improve the efficiency of paper-making.


  • enzymatically bleaching pulp rather than using chlorine.


  • de-inking of recycled paper.


  • using wood-processing wastes for energy production and as raw materials for manufacturing high-value organic compounds.


  • remediating soils contaminated with wood preservatives and coal tar.

GLOBAL BIOTECH CROP ACREAGE
According to the International Service for the Acquisition of Agri-biotech Applications (ISAAA), in 2006, global biotech crop acreage reached 252 million acres in 22 countries. This is an increase of more than 13 percent over 2005, when 222 million acres of biotech crops were grown in 21 countries. In 2006, the number of farmers growing biotech crops increased by 21 percent to 10.3 million farmers worldwide. Of these farmers, 9.3 million were small, resource-poor farmers in 11 developing countries.

Last year also saw a record domestic acceptance of biotech crops, according to the U.S. Department of Agriculture's (USDA) National Agricultural Statistics Service (NASS), with biotech crop acreage in the United States increasing in 2006 by 9.6 percent over 2005. In 2006, U.S. acreage of biotech soybean increased by more than six percent, to a total of 66.68 million acres, or 89 percent of all soybeans grown in this country. American farmers planted 12.68 million acres of biotech cotton in 2006, representing 83 percent of all cotton grown in the United States (an increase from 11.25 million acres planted in 2005). Plantings of biotech corn in the United States significantly increased in 2006 by nearly 14 percent to 48.4 million acres.

BENEFITS OF BIOTECH PLANTS



  • A May 2006 report from the University of Arizona found that Bt cotton reduces the level of pesticide applications while increasing overall crop yield.


  • Studies by the National Center for Food and Agricultural Policy (NCFAP) showed the benefits of growing biotech crops. NCFAP concluded that in 2005, biotech crops improved crop production by 8.3 billion pounds, reduced production costs by $1.4 billion, and increased farmer revenue by $2.0 billion. Additionally, American growers reduced pesticide applications by 69.7 million pounds by planting biotech crops.


  • A study by British agricultural economist Graham Brookes of PG Economics, released in late 2006, found that biotech crops had significant impact in reducing pesticide applications, reducing carbon emissions, and increasing global farm income.



    • The study found that agricultural biotechnology has reduced pesticide applications by nearly 495 million pounds since 1996. In soybeans only, there has been a 4.1 percent decrease in the amount of pesticide applications since 1996 as a result of biotech soybeans. According to the study, the United States, Canada, Argentina, and China benefited the most in reducing pesticide applications as a result of biotech crops.


    • Biotech crops can reduce the need for plowing to control weeds, which leads to better conservation of soil and water and a decrease in soil erosion and compaction. A reduction in plowing has also enabled farmers to significantly reduce the consumption of fuel and decrease greenhouse gas emissions. Brookes' study concluded that biotech crops have saved farmers 441 million gallons of fuel through reduced fuel operations, which has resulted in eliminating nearly 10.2 million pounds of carbon dioxide emissions since 1996. The study estimates that this is equivalent to removing four million cars from the road in one year.


    • The study estimates that since their introduction in 1996, biotech crops have increased global farm income by $27 billion. In 2005, global farm income increased by $5.6 billion as result of planting biotech crops. Of particular note, was that 55 percent of farm income gain in 2005 was to farmers in developing countries. Part of the increased farm income is a result in reduced farm costs due to biotech crops; since 1996, agricultural biotechnology has reduced farm costs by $350 million.

Animal Biotechnology

I. WHAT IS ANIMAL BIOTECHNOLOGY?
Animals are helping to advance biotechnology, and biotechnology is improving animal health in return. Combining animals and biotechnology can lead to progress in four areas:



  • Improved animal health.


  • Enhancements to animal products.


  • Environmental and conservation benefits.


  • Advances in human health.

Animal biotechnology includes all animals-livestock, poultry, fish, insects, companion animals and laboratory animals-and covers three primary technologies: genomics, cloning and transgenics.

A. ANIMAL GENOMICS
Having access to the genome of a livestock species makes it possible to identify individual genes and proteins that can control a host of commercially and economically crucial functions-everything from muscle growth and tenderness to disease resistance and reproduction. Even subtle differences in the genetic makeup of an individual animal can greatly affect its value for breeding, feedlot or branding purposes.

The diagnostic tools developed through the use of genomics are improving management practices, animal health and food quality. Traditionally, decisions regarding breeding or feedlot Selection were made by human observation. But genomic-based diagnostic and Selection tools replace "eyeballing" with scientific precision and efficiency, leading to more consistent and cost-effective results.

Benefits of DNA-based Products



  1. Disease surveillance and food safety: Using DNA to trace meat and animals through the food chain.


  2. Enhanced breeding and Selection: Developing animals with desirable traits such as greater muscle mass or milk or egg production.


  3. Improved animal production efficiency: Creating management systems based on genetic potential.


  4. Enhanced end product quality and consistency: Certifying branded meat (such as Angus beef) to meet consumer demand.

Genomic technology extends beyond the farm. The major pet registries use diagnostic tests to verify parentage. Research is under way to develop tests that can identify breeds in both purebred and mixed-breed animals and to identify genetic predisposition to disease.

B. ANIMAL CLONING
Livestock cloning is the most recent evolution of Selective assisted breeding in the ancient practice of animal husbandry. Arab sheikhs first used artificial insemination (AI) in horses as early as the 14th century. In the last 50 years, techniques such as embryo transfer, in vitro fertilization, embryo splitting, and blastomere transfer have become commonplace-providing farmers, ranchers and pet enthusiasts powerful tools for breeding the best animals.

Cloning does not change an animal's genetic makeup: it is simply another form of sophisticated assisted reproduction. Cloning allows livestock breeders to create an exact genetic copy of an existing animal-essentially an identical twin.

In December 2006, the U.S. Food and Drug Administration published a draft risk assessment that concluded that meat and milk products from animal clones and their offspring are safe for human consumption. As a new assisted reproductive technology, cloning can consistently produce healthier animals and a healthful meat and milk supply. FDA's draft risk assessment is consistent with numerous scientific studies, including two reports by the National Academy of Sciences, that have found the food from animal clones and their offspring to be safe. Globally, animal cloning my provide people in developing countries with greater access to protein-rich animal food products, which will increase community health and well-being.

Livestock Cloning Benefits
Cloning animals is a reliable way of maintaining high-quality livestock to meet our nutritional needs. Identifying and reproducing superior livestock genetics ensures herds are maintained at the highest quality possible.

Animal cloning offers benefits to consumers, farmers and endangered species:



  • Cloning accelerates the birth of the best possible stock and provides farmers with certainty of the genetic makeup of a particular animal.


  • Cloning reproduces the strongest, healthiest animals, thus optimizing animal well-being and minimizing the need for veterinary intervention.


  • Cloning can be used to protect endangered species. For example, in China, panda cells are kept on reserve as insurance against extinction.

C. TRANSGENIC ANIMALS
A transgenic animal is one that has had genetic material from another species added to its DNA. This breakthrough technology allows scientists to precisely transfer beneficial genes from one species to another. Transgenic technology can improve the nutritional value of animal products through enhanced genes. In addition, the technology promises improved animal welfare and productivity-a critical capability in meeting the food demands of a growing global population. Transgenic animals currently under development include pigs, cattle, fish and poultry, each of which will be thoroughly reviewed by the appropriate federal agencies before entering the marketplace.

Benefits of Transgenic Animals
Transgenic animals offer a plethora of benefits that will improve consumer health and nutrition, as well as animal welfare and productivity:



  • Increased nutritional value.


  • Quality assurance.


  • Higher efficiency production.


  • Stronger disease resistance.


  • Improved animal welfare-less disease and longer lifespan.

Animal Welfare & the Environment
By making animal welfare a priority, transgenic technology (as well as other animal biotechnology) offers tremendous potential benefits for animals. Specifically, it can help cut animal mortality and disease, as well as reduce or eliminate painful standard agricultural practices like castration and de-horning.

Transgenic technology can also be used to mitigate environmental impacts of livestock production. The EnviroPigTM, for example, dramatically lowers levels of phosphorus pollution. Such applications underscore the industry's commitment to environmental protection.

D. TRANSGENIC ANIMALS FOR ADVANCING HUMAN HEALTH
For decades, animals have been used to produce human pharmaceuticals. Horses, pigs, rabbits and other species have been enlisted to produce such products as anti-venoms, biologics to prevent organ transplant rejection and the blood thinner heparin. Biotechnology now allows us to modify genes in these animals so that the drug proteins are more compatible with human biochemistry.

Animal production also offers the most efficient, practical way to produce certain drugs that are difficult to make in sufficient quantities using other methods. For example, animals can make human antibodies to deadly infectious diseases if they are modified with human immune genes.

Transgenic technology can also be used to make animal organs more compatible for transplant into humans, a process called xenotransplantation. Heart valves from pigs are already used to replace damaged valves in human hearts. If xenotransplantation could be perfected with the help of transgenics, hundreds of thousands of lives could be saved each year.

Animal Welfare & the Environment
Biotechnology animals and their products are extremely valuable, often fragile, and animal welfare is a priority for everyone working with these animals. Animal-made pharmaceuticals, for example, cannot be produced in sick animals and so every effort must be made to ensure animal welfare.

Most of these technologies are being developed in domesticated animal species. Since these animals live on farms and do not mate with wildlife, the risk to the environment is miniscule. Moreover, the transgenic animals used to produce pharmaceuticals are expressly excluded from use in the food supply.

What's Next?
Biotechnology is providing the tools to make all these benefits an everyday reality for consumers. In addition to food applications, scientists are attempting to modify animals to produce therapeutic proteins to use in treating cancer, heart attacks, hemophilia, and rheumatoid arthritis, among other diseases. Some are researching the possibility of using these animals to grow transplant organs that can be used when other options have been exhausted. The largest impediment to successfully implementing these technologies is the absence of a clear regulatory pathway leading to commercialization. Another important challenge is educating the public, scientific and regulatory communities about the safety, effectiveness and benefits of these products.

In 2006, the European Commission approved the first pharmaceutical product manufactured with ingredients derived from biotech goats. The drug's ingredients include proteins from the milk of biotech goats. The pharmaceutical treats the rare blood-clotting disorder antithrombin deficiency.

II. HOW ARE PRODUCTS OF ANIMAL BIOTECHNOLOGY REGULATED?
Animal biotechnology is making incredible progress. If proven safe for animals, humans and the environment, it holds vast promise for improving our quality of life. Use of animal genomics, an extension of traditional animal breeding, is accepted as safe and is largely unregulated. However, scientists and industry leaders are awaiting final publication of a federal regulatory framework for cloning and transgenic animals.

Three government agencies regulate the animal health industry:



  • The U.S. Department of Agriculture regulates veterinary biologics, vaccines and diagnostic test kits.


  • The Food and Drug Administration reviews and approves new pharmaceuticals and feed additives.


  • And the Environmental Protection Agency regulates pesticides and topical products that kill fleas and other parasites.

The Office of Science and Technology Policy is reviewing the regulatory processes for the products of animal biotechnology, seeking coordination among the federal agencies for a science-based, streamlined approach. Little published regulatory guidance exists for many of the biotechnology products being developed.

In 2003, the U.S. Food and Drug Administration's Center for Veterinary Medicine published the draft executive summary of a food safety risk assessment regarding cloning of farm livestock and their offspring, including the safety of food products for human consumption. The FDA concluded that meat and milk from animal clones and their offspring were safe to eat. Next steps include finalizing the risk assessment and proposing a risk management process. Additionally, studies conducted by the National Academy of Sciences (NAS) and other new research have determined that cloned animals and their products are safe for human consumption.

III. USING BIOTECHNOLOGY TO IMPROVE ANIMAL HEALTH Healthy animals provide healthy foods. As of July 2003, there were 105 animal biotech products, including bacterins and killed virus vaccines, used in agricultural and companion animals. The animal health industry invests more than $400 million a year in research and development.

Biotechnology provides new tools for improving animal health and increasing livestock and poultry productivity. These improvements come from:



  1. An enhanced ability to detect, treat and prevent disea, ses and other problems.


  2. Better feed derived from transgenic crops designed to meet the dietary needs of different farm animals.


  3. Improved livestock productivity through improved animal breeding and disease resistance.

A. ENHANCING DETECTION, TREATMENT AND PREVENTION OF ANIMAL DISEASES
The animal health industry has developed many effective treatments that can prevent and treat dangerous livestock and poultry diseases. Quick diagnosis and treatment, coupled with strong preventative measures, help lower production costs and improve overall animal well-being. Additionally, healthier farm animals result in safer foods for consumers.



  • Biotechnology allows farmers to quickly diagnose the following infectious diseases through DNA and antibody-based tests: brucellosis, pseudorabis, scours, foot-and-mouth disease, bluetongue, avian leucosis, mad cow disease and trichinosis.


  • Farmers may soon be able to manage several farm animal diseases through biotechnology based pharmaceuticals, including foot-and-mouth disease, classical swine fever and bovine spongiform encephalopathy.


  • New biological vaccines protect farm animals from a wider range of diseases, including foot-and-mouth disease, scours, brucellosis, shipping fever, lung infections affecting pigs (pleuro-pneumonia, pneumonic pasteurellosis, enzootic pneumonia), hemorrhagic septicemia, fowl cholera, Newcastle disease of poultry, rabies, and infections that affect cultivated fish.


  • Molecular-based typing of pathogens, such as genetic fingerprinting, allows for the monitoring of the spread of disease within and between herds and can identify the source of an outbreak.


  • Genetic analysis of animal pathogens is leading to an improved understanding of the factors that cause disease and how best to control them.

B. BETTER FEED FOR ANIMALS FROM TRANSGENIC CROPS
Crops improved through biotechnology may provide nutritionally enhanced feed for farm animals. Improved feeds will raise animal size, productivity and growth rates. Biotech versions of several animal-feed crops are under study:



  • These products are designed to improve the quality of protein, oils or energy availability in the final animal food product.


  • One crop is designed to improve shelf life of beef by improving the antioxidant properties of the meat's fats.


  • Through biotechnology, increased digestibility of the low-quality roughages will allow crops to be more useful in feeding livestock.


  • Scientists are working on new crops to develop feed with edible vaccines for farm animals. In the near future, pigs could be fed transgenic alfalfa that would stimulate immunity to a serious intestinal virus.

C. IMPROVED LIVESTOCK PRODUCTIVITY THROUGH IMPROVED ANIMAL BREEDING AND DISEASE RESISTANCE
Improved animal breeding. Biotechnology plays a growing role in farm animal breeding programs. The goal of livestock producers is to Select the best animals for their breeding programs to obtain the same output (milk, eggs, meat, wool) with less input (food), or increased output with the same input. Improving animal health as well as increasing muscle mass and decreasing fat in cattle and pigs have long been goals of livestock breeders.

With genetic mapping techniques, animals that are naturally disease-resistant can be identified and used for breeding programs, resulting in naturally healthier offspring. Conversely, animals with genetic weaknesses and defective genes can be identified and removed from breeding programs. Examples of this work include the following:



  • New DNA tests can identify pigs with the genetic condition porcine stress syndrome, which causes tremors and death under stressful conditions.


  • Inherited weaknesses of cattle can be identified with DNA tests, which are currently being used in national breeding herds in Japan. Tests can identify leukocyte adhesion deficiency, which causes repeated bacterial infections, stunted growth and death within the first year of life. Other DNA tests can identify a hereditary condition that produces anemia and retards growth in Japanese black cattle.


  • Genetic mapping and the development of DNA markers are being used to identify genes in chickens that have developed a resistance to Marek's disease, a virus-induced disease similar to cancer.


  • USDA biotech researchers announced a breakthrough using transgenic technology that will help cows resist mastitis, a bacterial infection of milk glands that causes inflammation, swelling and lower milk production. Mastitis results in losses of up to $2 billion annually for U.S. dairy farmers.


  • Experimental cattle resistant to bovine spongiform encephalopathy are being produced using biotechnology techniques such as knock-out technology and cloning.


  • Researchers in Britain are developing chickens using transgenic technology that are resistant to avian influenza. If the birds are approved by regulators, it would take only four to five years to breed enough to replace the entire world population of chickens.

Assisted reproductive technologies (ART). Livestock producers are always interested in improving the productivity of agricultural animals and have used assisted reproductive technologies since the first use of artificial insemination in the 1950's. Livestock cloning is newest tool in the ART toolbox.

Using biotechnology to increase the productivity of livestock is a variation of Selective breeding. We Select the best individual animals that possess desirable traits; then, instead of breeding the animals, we collect eggs and sperm and allow fertilization to occur in a laboratory dish. This in vitro fertilization is followed by embryo culture, a form of mammalian cell culture in which the fertilized egg develops into an embryo. When the embryo is a few days old, it is taken from the laboratory dish and implanted into a female of the same species-but not necessarily of the same breed. This is known as embryo transfer.

Sometimes, the embryo, which is a clump of cells at this stage in development, is divided into several parts, and each cell cluster is implanted. This is a form of cloning that has been used for a few decades to improve the genetic makeup of the herd more quickly than by simply relying on a single female that produces one calf per year.

The industry that is commercially cloning farm livestock also uses somatic cell nuclear transfer. Animals that have been cloned for show ring purposes include cattle, pigs, sheep and horses.

D. ADDITIONAL HEALTH APPLICATIONS OF BIOTECHNOLOGY IN ANIMAL AGRICULTURE
The biotechnology industry has proposed additional unique solutions for animal health and food safety.



  • DNA sequencing of individual animals could serve as the ultimate animal identification, allowing for tracking of meat from farm to table.


  • A biotech vaccine for Newcastle disease in chickens was approved by the USDA. This vaccine is a plant-made pharmaceutical developed to improve animal health.


  • A cattle vaccine produced in plants could reduce Escherichia coli 0157:H7 shedding in feedlot cattle, a further assist toward improved food safety on the farm.

IV. ENHANCING ANIMAL PRODUCTS
Biotechnology can dramatically improve animal products that humans consume and use. Some of these improvements result from vaccines, medicines and diagnostic tests that make animals healthier. However, biotechnology has also made great strides in enhancing animal products at a cellular level through genomics, cloning and transgenic technologies. Recent breakthroughs include the following:



  • A study published in 2005 by the University of Connecticut and Japan's Kagoshima Prefectural Cattle Breeding Development Institute found meat and milk products from cloned cattle are safe for consumption. The results parallel those of two National Academy of Sciences reports in 2002 and 2004.


  • Researchers can produce biotech cows, pigs and lamb with reduced fat and increased lean muscle.


  • Recent research showed that pigs could be produced with higher heart healthy omega-3 fatty acids, using transgenic technology.


  • Genetic mapping projects allow farmers to identify highly productive animals for breeding programs. Genomics technology is being applied to improving the conventional breeding of superior animals in order to produce desirable traits.



    • Genetic technologies are finding a place in the beef industry.



      • In 2003, the first validated SNP beef cattle genome was created. SNP (single nucleotide polymorphism) technology is being used to identify clusters of genes that contribute to a trait-for example, leaner beef cattle. Then, through conventional breeding, lines of cattle are being developed that express the increased muscling.


      • A DNA test has been approved to verify Angus beef.


    • Worldwide, research teams are working to sequence the genomes of a wide variety of animals. In October 2004, the Bovine Genome Sequencing Project announced it had successfully sequenced the cow genome. In December 2004, the Chicken Genome Sequencing Consortium announced it had sequenced the chicken genome. In late 2005, a new Consortium for Swine Genome Sequencing was launched.


  • Biotech cows can now produce "designer milks" with increased levels of protein that can improve the diet of children or affect production of cheese and yogurt.


  • Scientists are now working to remove from milk the proteins that cause lactose intolerance. It is estimated that 90 percent of the Asian population is lactose intolerant.


  • Australian scientists have increased wool production by feeding sheep biotech lupin, a mainstay of sheep's summer diet.


  • Scientists are working to develop biotech shrimp that lack the protein responsible for 80 percent of shrimp allergies.

V. ENVIRONMENTAL AND CONSERVATION EFFORTS THROUGH ANIMAL BIOTECHNOLOGY

A. ENVIRONMENTAL IMPACTS
Livestock producers are challenged with disposing of more than 160 million metric tons of manure annually. Animal manure, especially that of swine and poultry, is high in nitrogen and phosphorus, which can contribute to surface and groundwater pollution.



  • Several crops improved with biotechnology may offer animal feed that decreases phosphorus and nitrogen excretion, total manure excretion and offensive odors.


  • Further, the EnviroPig is a biotech pig that is environmentally friendly. This pig has a gene added to enhance salivary phytase, thereby improving phosphorus digestibility and retention of phosphorus, with reduced excretion of phosphorus in the manure of the animal. The goal is to lower the chance of manure contributing to groundwater contamination in areas that surround livestock farms.

B. ENDANGERED SPECIES CONSERVATION
Biotechnology is providing new approaches for saving endangered species. Reproductive and cloning technologies, as well as medicines and vaccines developed for use in livestock and poultry, can also help save endangered mammals and birds.

Borrowing biotechnology techniques used by livestock breeders, veterinarians at the Omaha zoo recently used hormonal injections, artificial insemination, embryo culture and embryo transfer to produce three Bengal tiger cubs. A Siberian tigress served as the surrogate mother for these embryos.

Worldwide, researchers have used cloning technologies to conserve endangered species. In September 2001, researchers at the University of Teramo, Italy, created a clone of the European mouflon, the world's smallest wild sheep. There are thought to be fewer than 1,000 adult mouflons in Sardinia, Corsica and Cyprus.

In January 2001, the world's first cloned endangered species, an ox-like guar, was born in the United States, though it succumbed to a common dysentery infection. There are estimated to be fewer than 36,000 guars in India and Southeast Asia due to human development of their natural habitat.

Researchers also have worked to clone the argali, the largest wild sheep, but have been unable to produce live offspring.

In December 2003, the first cloned whitetail deer was reported in the United States. Though not an endangered species, researchers believe the successful clone will provide valuable insight into cloning other wild animals, including endangered species.

In April 2003, the San Diego Zoo reported the birth of a cloned banteng, a wild cow native to the island of Java. Since January 2004, the banteng has been on public view at the San Diego Zoo; it is the first cloned species to be on display to the public at any zoo.

Researchers at the San Diego Zoo also employ other biotech and reproductive technologies in their conservation efforts. In 1975, they created the Frozen Zoo, a genetic bank that currently houses frozen cells from more than 7,000 endangered or threatened mammals, birds and reptiles. Other animal conservation organizations, including the Zoological Society of London and the Cincinnati Zoo, have created genetic databases to store cryogenically frozen samples of DNA, gametes and cell tissues for later use.

Recently, Chinese scientists announced that they are close to cloning the Giant Panda using trans-species cloning technology. The Giant Panda is a highly endangered species.

Furthermore, in 2005, an endangered species of Mongolian gazelle was cloned for the first time. The year also marked several other animal cloning firsts, including water buffalo and an Arab endurance champion horse.

Early in 2006, the first commercially cloned horses were born; champion cutting horses were cloned and healthy foals have been born.

Biotechnology techniques for working with endangered species have not been limited to cloning. Some researchers are using genetic samples to study the distribution of species and track the relationships between different groups of animals. These studies may help to prevent excessive interbreeding among small groups of animals.

Genetic studies also can help produce a healthier population of endangered species through increased genetic diversity. Conservationists studying the endangered Florida panther realized that, as the population shrank, inbreeding became more common. Through genetic testing, researchers found that the panthers were closely related to Texas cougars and had previously interbred. By introducing some cougars in the Florida panther breeding pool, scientists increased the genetic diversity of the species, resulting in a healthier panther population.

VI. ANIMAL BIOTECHNOLOGY TO ENHANCE HUMAN HEALTH
Transgenic animal-made antibodies can be produced from animals that have had human antibody genes transferred to them. These animals can then be vaccinated against human diseases and antibodies can be collected from their blood and used for treating diseases in humans.

Animals are often used as models for research as many of the technologies developed for animals can be transferred to humans. Some of the work being done with animals that will advance human health:

A. XENOTRANSPLANTATION
Extensive research has been done on the potential for using biotech animals as blood or organ donors for humans. The primary barriers to successful xenotransplantation include the immune reactions of the recipient to the graft, the possibility that animal tissues or organs might not function well in a human recipient, and the possibility that the xenotransplant might carry infection. Biotechnology has been used to address the problem of immunorejection, and biotech pigs have been developed with organs that may resist rapid rejection by the human immune system.

B. "PHARM" ANIMALS
Researchers are developing transgenic animals, including cows, goats and sheep, that produce milk containing therapeutic proteins. These proteins may be used to nourish premature infants or to treat emphysema, cystic fibrosis, burns, gastrointestinal infections and immunodeficiency diseases such as AIDS. Some interesting ongoing projects include:



  • The first drug product for humans produced by a transgenic animal was recently (July 2006) approved by the European Commission. This protein is human anti-thrombin, a naturally occurring plasma protein that has both anti-coagulant and anti-inflammatory properties. The protein is produced by transgenic goats whose milk contains human anti-thrombin.


  • In 2005 in Argentina, cows were improved with biotechnology to produce human growth hormone. Scientists estimate that just 15 of these Jersey cows could produce enough human growth hormone to meet the current world demand.


  • Dutch researchers are working with biotech rabbits that secrete a potential drug for Pompe's disease in their milk. Pompe's disease is an extremely rare genetic disorder that can result in crippled muscles, breathing problems and sometimes death.


  • Scientists are working with biotech goats that produce an experimental anticancer medication.


  • Biotech cows can now produce the human milk protein lactoferrin, which is an antibacterial protein that can be used to treat immunosupressed patients or incorporated into infant formula.

Aquaculture

Aquaculture is the growth of aquatic organisms in a controlled environment. The increased public demand for seafood, combined with the relatively small supply of aquaculture products provided by U.S. companies, has encouraged scientists and industry to study ways that marine biotechnology can increase the production of marine food products. By using biotechnology techniques, including molecular and recombinant technology, aquaculture scientists study the growth and development of fish and other aquatic organisms to understand the biological basis of traits such as growth rate, disease resistance or resistance to destructive environmental conditions.

Researchers are using marine biotechnology to identify and combine valuable traits in parental fish and shellfish to increase productivity and improve product quality. The traits scientists and companies are investigating for possible incorporation into several marine organisms include increased production of natural fish growth factors and the natural defense compounds marine organisms use to fight microbial infections. Biotechnology is also improving productivity through the development of feed additives, vaccines and other pharmaceutical agents.

A. BIOTECH SALMON
As of September 2006, eight states have passed legislation or have regulations banning various uses of transgenic fish, including Maryland, California, Oregon, and Washington. In 2005, Alaska passed legislation requiring labeling of food from transgenic fish. However, no transgenic fish are approved in the United States, nor in the world, for human consumption at this time.

Some of the biotech improvements being made with fish include:



  • Some biotech salmon reach maturity quickly and do not hibernate, which enables year-round availability of salmon.


  • Researchers are trying to develop fish that are more resistant to disease, tolerant of low oxygen levels in the water and tolerant to freezing temperatures.


  • Some species of fish naturally produce a protein that allows them to survive in the Arctic. This "anti-freeze" gene has been transplanted to other species of fish so they can survive in very cold waters.

C. COMPANION ANIMALS
Approximately 164 million dogs and cats are companion animals in the United States (in more than 60 percent of all American households). America's emotional attachment to its pets is evidenced by the estimated $38.4 billion spent on U.S. pets in 2006. To help companion animals live longer and healthier lives, pet owners spent more than $7 billion on veterinary care and healthcare products in 2000 (the most recent year for which a statistic is available).

The animal health industry has developed products that contribute to the well-being of companion animals. Pets benefit from preventive medicines and disease treatments that have been improved through biotechnology. Animal vaccines are critical to preventing diseases such as rabies, distemper, feline leukemia and hepatitis. In addition, researchers have developed biotechnology-based products to treat heartworm, arthritis, parasites, allergies, dental problems, heart disease, kidney failure, separation anxiety, cognitive dysfunction syndrome and other problems.

Recent biotechnology-driven developments in companion animal health care include the following:



  • Immunologists have developed a vaccine for feline immunodeficiency virus (FIV), an organism carried by as many as 25 percent of cats. In addition to saving cats' lives, the research for creating the FIV vaccine provides many clues in the development of an HIV/AIDS vaccine.


  • Gene therapy has restored the vision of dogs afflicted by Leber congenital amaurosis, an untreatable condition that causes almost complete blindness. Currently researchers are successfully testing gene therapy for melanoma, canine lymphoma and bone cancer. Canine lymphoma accounts for 20 percent of all canine tumors and usually kills within a month of diagnosis. Gene therapy treatment may prolong life by a year.


  • A rabies vaccine has been widely used with wild raccoon populations to limit transmission to companion animals. In the United States, an estimated 40,000 people undergo treatment for rabies annually at an average cost of $1,650.


  • Projects for mapping the genetic code of fleas may someday result in products that rid dogs and cats of the insect.


  • Monoclonal antibody technology is being used to develop treatments for canine lymphoma.


  • Other antibody technology is being used to develop diagnostics for feline infectious peritonitis and feline immunodeficiency virus.

Other recent biotechnology driven developments in companion animals are listed below:



  • An allergen-free cat is being developed.


  • The first biotech animal to be sold to the public reached the market in January 2004; GloFish are biotech ornamental fish that contain a gene from a sea anemone. Under black light, the GloFish fluoresce in a brilliant red color. The U.S. Food and Drug Administration conducted a complete scientific and technical review of the biotech fish, including assessing target animal safety, human safety and environmental safety, and found them safe and environmentally harmless.

 
发表时间:2008-7-18
 
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