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AquAdvantage Salmon Approval

Based on a comprehensive analysis of the scientific evidence, as required by the Federal Food, Drug and Cosmetic Act (FD&C Act), the FDA has determined that AquAdvantage Salmon meets the statutory requirements for safety and effectiveness under the FD&C Act. The salmon are safe to eat, the introduced DNA is safe for the fish itself, and the salmon meet the sponsor's claim about faster growth. Because the sponsor has met these requirements, the FDA must approve the application.

The FDA has also analyzed the potential environmental impact that an approval of the AquAdvantage Salmon application would have on the quality of the human environment in the United States and has issued its final Environmental Assessment and Finding of No Significant Impact.

How the AquAdvantage Salmon is different from other fish

AquAdvantage Salmon has been genetically engineered to reach a growth marker important to the aquaculture industry more rapidly than its non-GE farm-raised Atlantic salmon counterpart. It does so because it contains an rDNA construct that is composed of the growth hormone gene from Chinook salmon under the control of a promoter (a sequence of DNA that turns on the expression of a gene) from another type of fish called an ocean pout. This allows the salmon to reach a growth marker important to the aquaculture industry faster than non-GE farm-raised Atlantic salmon.

Food safety evaluation

As part of its review of the application, during which the agency held an open public meeting, took public comment, and released draft environmental documents for public review, the FDA determined that food from AquAdvantage Salmon is as safe to eat as food from non-GE Atlantic salmon. In addition, the nutritional profile of AquAdvantage Salmon is comparable to that of non-GE farm-raised Atlantic salmon.

As part of its evaluation, the FDA examined data comparing three groups of fish: non-GE farm-raised Atlantic salmon from both the sponsor's farm and from a different commercial farm, and AquAdvantage Salmon. This study compared key hormones (including estradiol, testosterone, 11-ketotestosterone, T3, T4 and insulin-like growth factor 1 (IGF1)) and found no biologically relevant differences.

Containment

Under the approval, AquAdvantage Salmon are subject to stringent conditions to prevent the possibility of escape into the wild. The salmon cannot be raised in ocean net pens: instead, the approval allows for them to be grown only at two specific land-based facilities: one in Canada, where the breeding stock are kept, and Panama, where the fish for market will be grown out using eggs from the Canada facility.

Both the Canada and Panama facilities have multiple and redundant physical barriers to prevent eggs and fish from escaping, including metal screens on tank bottoms, stand pipes, and incubator trays to prevent the escape of eggs and fish during hatching or rearing.

The tanks also have covers, nets, jump fences, and screened overflow tanks to prevent escape over the sides of the tanks or incubators. Tank netting also keeps predators such as birds from entering the fish tanks at the outdoor facilities in Panama. The facilities in Canada are indoors. All tank drains and stand pipes have covers or sleeves permanently attached to them.

In order to prevent eggs or small fish from passing through the pipes or plumbing, there is a closed septic system and additional screens and chlorine pucks are used to kill any escaped fish or eggs in the main drain area.

In addition, particularly at the Panama grow-out facility, there are geographical/geophysical containment features, including high river and ocean water temperatures, and other conditions that would not be supportive of salmon survival. The fish to be produced for food in Panama will be an all-female, reproductively sterile population.

The FDA has inspected the Canadian facility twice and, with a representative of NOAA's National Marine and Fisheries Service, performed an extensive site visit of the Panamanian facility. Based on the agency's review of these facilities, the agency is confident that the possibility for escape is highly unlikely, and that the procedures in place to monitor physical containment are appropriate. The FDA will maintain regulatory oversight over the egg production and grow-out facilities for the entire duration of the product lifecycle, and will conduct inspections to confirm that adequate physical containment measures remain in place. In addition, the Canadian and Panamanian governments have conducted and will continue to conduct inspections of the facilities.

Evaluation of environmental effects

In compliance with requirements of the National Environmental Policy Act (NEPA), the FDA evaluated whether approval of the application would result in significant impacts on the quality of the human environment in the United States.

Based on the multiple forms of physical and biological containment proposed by AquaBounty Technologies in the application, the FDA found that an approval of the application related to AquAdvantage Salmon would not cause a significant impact on the environment of the United States. This finding is based on the extremely low likelihood that AquAdvantage Salmon could escape from the Canada and Panama facilities and survive in an ocean or waterway to interbreed with wild Atlantic salmon. This is due, in part, to the physical and biological containment measures specified in the approved application. Based on the agency's conclusion from the final Environmental Assessment, the agency issued a final Finding of No Significant Impact (FONSI).

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AquAdvantage Salmon Approval Based on a comprehensive analysis of the scientific evidence, as required by the Federal Food, Drug and Cosmetic Act (FD&C Act), the FDA has determined that AquAdvantage Salmon meets the statutory requirements for safety and effectiveness under the FD&C Act.

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GM insect-resistant traits used in cotton have accounted for 99.3% of additional cotton production. Positive yield impacts from the use of this technology have occurred in all user countries (except for genetically modified insect resistant cotton in Australia where the levels of Heliothis sp.

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Everyone knows the Internet is for cats. Nothing else, just cats. Cats are fun, cats are cute, and cats have the ability to improve the quality of any day. I mean, just look at this guy!

Your day is better already.

But wait: aside from chemistry puns, can cats make any important contributions to science? Yes, they do - and in a big way. The Mayo Clinic is now using felines as test subjects to research AIDS, an immunologic disease. And while this sounds pretty cool, it gets even better: these cats glow in the dark.

Bioluminescence, the ability to emit light, occurs naturally in organisms like jellyfish, insects and fungi (please note, this group does not include cats). In 1961, Osamu Shimomura (a Boston University graduate and Nobel Prize winner) and his colleagues, Martin Chalfe and Roger Y. Tsien, isolated the protein responsible for bioluminescence in the jellyfish species Aequorea victoria. ¹ This protein is called Green Fluorescent Protein (GFP). A non-bioluminescent organism can be genetically modified to emit light if the DNA sequence encoding for GFP is incorporated into its genome.

When scientists want to incorporate a specific DNA sequence into an organism for research, it is difficult to determine if the sequence has been properly integrated. To be sure the DNA sequence is functional within the organism, the GFP gene is inserted into the organism's genome at the same time as the DNA sequence to be researched. If the organism is bioluminescent, the specific DNA sequence has properly integrated into the genome. The fluorescence thus acts as a tag for successful integration, allowing easy identification of the modified organism.

At first, bioluminescence tags were only used in single-celled organisms. Now, scientists use the protein in multi-celled organisms ... like cats. In this case, the cats that are "tagged" with the glowing GFP protein also successfully produce a protein that protects them against the Feline Immunodeficiency Virus (FIV). 2, 3 FIV is the virus that causes feline AIDS, and is comparable to Human Immunodeficiency Virus (HIV) and the AIDS epedemic. ² Because of this, the research involving FIV may also be applicable to humans, helping both species in their struggle against AIDS.

Several other experiments must be completed before we know the benefits of this research, but the results so far are promising. Both GFP and the protective protein transfer through natural reproductive processes, 2 promising at least two things:

1) FIV and AIDS research will continue to test the effectiveness of the protective protein. If the protein proves effective, the transferable nature of the gene may be applied to the whole population of domestic cats. This may then be modified and applied to humans.

2) As research continues, there will be more glowing cats! Everyone wins!

References

¹ Shimomura, Osamu. Autobiography. Retrieved from http://www.nobelprize.org/nobel_prizes/chemistry/laureates/2008/shimomura. html

² Nellis, Robert. (2011, September 11). Mayo Clinic Teams with Glowing Cats Against AIDS, Other Diseases: New technique gives cats protection genes. Retrieved from http://www.mayoclinic.org/news2011-rst/6434.html

³ Wongsrikeao, Pimprapar and Dyana Saenz, Tommy Rinkoski, Takeshige Otoi & Eric Poeschla. Antiviral transcription factor transgenesis in the domestic cat. Nature Methods. 11 September 2011. Retrieved from http://www.nature.com/nmeth/journal/vaop/ncurrent/full/nmeth.1703.html

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Everyone knows the Internet is for cats. Nothing else, just cats. Cats are fun, cats are cute, and cats have the ability to improve the quality of any day. I mean, just look at this guy! Your day is better already. But wait: aside from chemistry puns, can cats make any important contributions to science?

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Cute&Cool Pets 4U: Biggest Dogs In The World Pictures

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Animals That You Didn’t Know Exist - Wendy the Muscle Whippet

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Introduction

Bt cotton is an insect-resistant transgenic crop designed to combat the bollworm. Bt cotton was created by genetically altering the cotton genome to express a microbial protein from the bacterium Bacillus thuringiensis. In short, the transgene inserted into the plant's genome produces toxin crystals that the plant would not normally produce which, when ingested by a certain population of organisms, dissolves the gut lining, leading to the organism's death.
Mechanisms of Action
Bt is a family of proteins originating from strains of the bacterium Bacillus thuringiensis. There are more than 200 different types of Bt toxins, each affecting different types of insects. The Bt cotton plants are genetically modified by the addition of genes encoding toxin crystals in the Cry group of endotoxin. When ingested by insects, the Cry toxins are dissolved and activated by the high pH environment of the animal's gastrointestinal system. In the midgut, the activated Cry molecules bind to cadherin-like proteins on cells comprising the brush border membrane. The epithelium of the brush border membrane has the function of maintaining separation of the body cavity from the gut while allowing absorption of nutrients from the digested food bolus. Cry toxins bind to specific locations on the cadherin-like proteins present on the epithelial cells of the midgut, and form ion channels allowing potassium ions to flow from the cells. As the control of potassium ion concentration is critical to the survival of every living cell, they are tightly regulated under normal function. With the formation of Cry ion channels and the subsequent efflux of potassium ions, the affected epithelial cells lyse and die. This creates gaps in the brush border membrane, allowing bacteria and Bt spores to enter the body cavity. Subsequently, the insect will die of internal infection after ingesting a Bt crop.

Cotton is a crop of very high economic value because of its widespread demand in the textile industry, representing 38% of the fiber market. The uses of the cotton fiber and its seeds are widespread, ranging from clothing, upholstery, cosmetics, packaging to cottonseed-oil, paper, electrical equipment, and livestock feed. As of 2008-2009 reports, the largest producer of cotton is China, followed by USA and India. For such an important cash crop, the loss of hundreds of acres worth of harvest due to attack by pests proves to be a big loss to farmers as well as the industry. It also leads to waste of precious resources like soil, water and labor.

1901 - Japanese biologist, Shigetane Ishiwatari first isolated the bacterium Bacillus thuringiensis (Bt) as the cause of the sotto (sudden-collapse) disease

1911 - Ernst Berliner isolated a bacteria that had killed a Mediterranean flour moth and rediscovered Bt. He named it Bacillus thuringiensis, after the German town Thuringia where the moth was found.

1915 - Berliner reported the existance of a crystal within Bt, but the activity of this crystal was not discovered until much later. Farmers started to use Bt as a pesticide in 1920

1956 - Researchers Hannay, Fitz-James and Angus found that the main insecticidal activity against lepidoteran (moth) insects was due to the parasporal crystal. With this discovery came increased interest in the crystal structure, biochemistry, and general mode of action of Bt. Research on Bt began in ernest.

Starting in 1958 - In the US, Bt was used commercially.

By 1961 - Bt was registerd as a pesticide to the EPA.

1980's - Use of Bt increased when insects became increasingly resistant to the synthetic insecticides and scientists and environmentalists became aware that the chemicals were harming the environment. Bt is organic and it affects specific insects and does not persist in the environment. Because of this, governments and private industries started to fund research on Bt.

1995 - With the advancement in molecular biology, it soon became feasible to move the gene that encodes the toxic crystals into a plant. The first genetically engineered plant, corn, was registered with the EPA .

1996 - Bt cotton was introduced into US agriculture

For cotton growers, there was a lot of pressure from pests before the introduction of Bt cotton in 1996. Farmers were losing much of their cotton to tobacco budworms, cotton bollworms, and pink bollworms.In 1995, attacks from these pests reduced U.S. cotton yields by over 4%, or by over a quarter billion dollars worth of cotton.

This is where biotechnology came in - to develop such a strain of cotton which will be resistant to the most common pests which cause large losses worldwide. After the introduction of Bt cotton in 1996, there was a significant decrease in the cost of pesticides applied and a big boost in the amount of cotton produced which was reflected in the reduction of cotton prices in the US between 1996 and 1998.

The cotton bollworm, which was controled using Bt technology in the US in this period, is a very dangerous pest worldwide. Cotton bollworm larvae damage cotton bolls and squares. Larvae chew holes into the base of bolls and may hollow out locks. Larvae may also chew shallow gouges in the boll surface, which can become infected with rot organisms. Squares injured by cotton bollworm usually have a round hole near the base.

Traditionally, the cotton bollworm has been combated by the use of pesticides. However, in developing nations like India, there is a huge cost of using large amounts of pesticides, which typically cannot be afforded by marginal farmers. Bt cotton was developed with the intention of reducing the amount of pesticides needed for cotton monoculture, thereby reducing the cost of growing cotton and reducing the environmental impact of heavy pesticide use. Researchers at Monsanto developed Bt cotton and it has become widespread since the first commercial release in China and the United States in 1996, followed by its introduction in India in 2003.

An Introduction to the Debate over Bt Cotton in India

Even though India's total cotton production ranks 3rd internationally behind China and the U.S., the acreage under cotton cultivation in India is about 25% of all agricultural land, the highest of any country. One main reason is that the production of cotton per hectare is very low, and India ranks 70th in the world in the kg/hectare production of cotton. The reduced productivity of Indian cotton is often attributed to intense and diverse pest pressure and the lack of irrigation infrastructure. The hope was that the introduction of Bt Cotton would largely take care of the main pest problems and reduce the use of pesticides.

The use of BT cotton in India has raised a lot of controversy even before its official introduction in India. It all began when Monsanto partnered up with an Indian seed company MAHYCO in 1993 in a bid to introduce Bt cotton seeds in India. After a slow start with the Government of India's Department of Biotechnology, a 50-50 joint venture called MAHYCO-Monsanto Biotech (MMB) was formed in 1998. They managed to acquire permission for field testing of Bt cotton seeds countrywide, and in 2001, they finally approached the GEAC (Genetic Engineering Advisory Committee) for the commercial release of Bt cotton varieties. GEAC withheld large scale cultivation and MMB was told to do more field trials for another year. In a press statement, the GEAC said, "MAHYCO may like to conduct field trials on farmer's field in an area of about 100 hectares under close supervision of GEAC and Monitoring and Evaluation committee." It also advised collection of the complete evidences and data pertaining to impact of transgenics on human and animal food, spread of the cry protein resistant boll worm and impact on non-target soil microflora and other fauna. However, in 2001, Gujarat faced a bad bollworm attack which devastated many acres of cotton fields. But some fields, remarkably, were mostly immune. This made MMB suspicious and they realized that the Cry1ac gene they had patented had spread out into the hands of the local seed company, Navbharat. The owner of Navbharat, D.B. Desai was taken to court by the infuriated MMB and questioned about this. D.B. Desai was later arrested and Navbharat was forbidden from selling these seeds, but the effectiveness of the Bt technology resulting in higher yields and reduced use of pesticides has nonetheless been proved.

Bt cotton has great promise as it is resistant to one of the major pests that decreases crop yield. However, the seed does come at comes at a much higher price. Seeds are purchased with loans from local money-lenders that charge very high interest rates, so farmers incur big debts to obtain the seed. Also, the seeds are resistant to the American bollworm but are not completely resistant to all pests, a fact that is not known by all farmers. If they do not have additional pest control strategies, even a Bt crop may be lost to pests. The situation is greatly worsened by counterfeit seed on the market that does not contain the Bt gene, so is susceptible to the bollworm and has no yield benefit. Even worse, if farmers do not know to spray pesticide on their counterfeit Bt fields, they may lose the entire crop to pests.

While Bt seeds have been successfully used by some farmers in India, others have been caught into vicious debt traps and low yielding harvests, as described above. This led to some poor marginal farmers committing suicide over the losses they have incurred. The farmer suicides happened in large numbers around 2004-2006 in the areas that cultivated cotton and a lot of these farmers drank the pesticides they sprayed on their crops out of despair.

Because of all the complicating socio-economic factors in a developing country like India, including trade laws, seed prices, counterfeit seeds, and high interest, as well as the high pest pressures that already exist, it is difficult to determine the role that the introduction of Bt cotton played. There are no reliable data sets available of the number of farmers that have committed suicide that were or were not using Bt seed. The low acceptance level of GM technology by the public makes it more difficult to tease out the many factors, since Bt has already been publically blamed as the cause. More thorough and unbiased ground-level research will have to be done to get a clear picture of whether Bt technology has really caused all the adverse effects on the lives of farmers or if surrounding social, political, and economic factors are responsible.

Looking through the magnifying glass - Has the introduction of Bt cotton worsened poverty, debt and farmer suicides in India?

The factors surrounding the socio-economic problems being faced by farmers and how these problems may be affected by Bt cotton are discussed below:

1. Economic effects: Can people afford the technology?

65-70% of India's population work in agriculture. Many of these people are poor farmers working on a small plot of land, mostly by hand and other basic farming methods, machines and technology. Many are grappling with the problems of illiteracy and feeding a large family with the limited land they own. The mechanisms to obtain low-interest loans without collateral, including microfinance, are not yet established in very rural areas of India. In such a setting, the only source of loans are the local money-lenders who charge exorbitant interest rate for their services, up to 100-120% per annum. A small farmer who buys expensive seeds and pesticides gambles on having to high enough yields that he will be able to pay back a loan with interest while still making enough to live on. This is very risky when yields are variable, there is no irrigation, and there is only a minimal concept of crop insurance. In summary, the restricted flow of capital to small farmers plays a big role in the use of Bt technology.

2. Social effects: Can people use the technology?

Illiteracy is a rampant problem among the poorest sections of society in India. The proper use of Bt is not explained to the farmers, and they are not educated enough to find out on their own. They are unable to adopt the technology in ways that will supply the highest yields in the safest ways. For example, farmers do not know that additional pesticides may be needed to combat pests that are not susceptible to Bt. They do not know to plant non-Bt refuges to combat insect resistance or to plant 5 rows of non-Bt cotton around their fields to prevent pollen flow to nearby non-Bt fields. There is no enforcement machinery in place in India to ensure proper implementation. The lack of education and of enforcement has led to apprehension about Bt, including unfounded rumors about things like cattle dying when they eat Bt cotton plants. An additional problem is that people have left behind traditional knowledge that had been used in farming, including pest control strategies, instead of integrating Bt into already existing systems.

3. Socio-economic effects: What happens when a crop fails?

India's agriculture is mainly rain-fed and low-tech. If a farmer loses his crop due to drought or other extraneous factors, there is no mechanism to help pay back loans and interest. This can lead to the farmer committing suicide. Though the government may on paper have some mechanism of supporting a farmer whose crop has failed, many farmers are not compensated due to corruption, bureaucracy, and the sheer volumes of farmers that need help.

4. Socio-ecological effects: Is the seed pure?

In order for Bt cotton to be effective, the plants in a field must all contain the Bt gene, because plants without the gene are not resistant to bollworm. Counterfeit seed that contains either some or no Bt seed is sold by unscrupulous or unknowing seed dealers at prices lower than those offered by Mahyco-Monsanto, and under the same technology name. One source of counterfeit seed is to collect seed produced by Bt plants. Since the seeds may be fertilized by pollen from non-Bt plants, the resulting seed will not all contain the gene. Farmers do not spray pesticide on their counterfeit Bt fields, so may lose the entire crop to pests. This misleads farmers about the efficacy of the technology.

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Bt cotton is an insect-resistant transgenic crop designed to combat the bollworm. Bt cotton was created by genetically altering the cotton genome to express a microbial protein from the bacterium Bacillus thuringiensis.

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Cold Strawberries: A gene from a type of salmon that allows it to survive cold temperatures has been isolated and inserted into a strain of strawberry. This strawberry can survive and grow in cold temperatures. 

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Cold Strawberries: A gene from a type of salmon that allows it to survive cold temperatures has been isolated and inserted into a strain of strawberry. This strawberry can survive and grow in cold temperatures. 