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Category Archives: Biotechnology
On eve of biotech’s big convention, BIO boss talks drug prices, ‘biosimilars’ and Trump BioFlash podcast – San Francisco Business Times
Posted: June 19, 2017 at 7:46 pm
On eve of biotech's big convention, BIO boss talks drug prices, 'biosimilars' and Trump BioFlash podcast San Francisco Business Times As 16,000 biotech executives land in San Diego this week for the annual Biotechnology Innovation Organization conference, old issues continue to simmer while new ones emerge with the rise of President Donald Trump. The BIO convention, which runs ... The BIO International Convention Kicks Off Four Days of Breakthrough Programming in San Diego |
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Biotechnology could spur Africa’s industrialisation – Southern Times Africa
Posted: June 19, 2017 at 7:46 pm
Sifelani Tsiko recently in Lilongwe, Malawi
An industrial development strategy could be built on the back of Africas agricultural sector underpinned by the adoption of new and emerging technologies such as biotechnology to support improved yields, value addition and services that feed into the whole agro-processing value chain, a top Common Market for Eastern and Southern Africa (COMESA) official says.
Getachew Belay, a senior biotechnology policy advisor told Zimpapers Syndication recently on the sidelines of a communication training workshop for journalists on biotechnology and biosafety, that the adoption of genetically modified cotton developed using a bacterium Bacillus thuringiensis (Bt) which naturally produces a chemical harmful only to a small fraction of insects such as the bollworm, could increase yields and enhance competitiveness.
He says cotton farmers in Africa suffer huge losses due to pest problems.
The most destructive of pests is the African bollworm (Helicoverpa armigera), which can cause severe losses of up to 100 percent like we saw on some cotton fields in Salima here in Malawi, the Comesa biotech policy advisor says.
In unprotected fields pest damage can be very severe and when you look at Bt cotton crop on trial you can see hope that its possible for African farmers to increase their yields and competitiveness of their crop on the market.
Using Bt cotton developed using bacterium Bacillus thuringiensis, which naturally produces a chemical harmful only to a small fraction of insects such as the bollworm, experts say reduction in pest infestations can increase yields and improve the livelihoods of cotton growers.
The Bt toxin is inserted into cotton, causing cotton, called Bt cotton, to produce this natural insecticide in its tissues.
Biotechnology experts argue that cotton farmers in Zimbabwe, Malawi and most other African countries, can effectively reduce input costs and control damage from bollworms and other insects that frequently damage cotton by adopting Bt cotton.
For several decades, has lagged behind in terms of the industrial dynamism required to boost farmer earnings, employment, economic growth and competitiveness on the global market.
But in recent years, there is a growing realisation of the importance of industrialisation.
In 2016, the UNs Economic Commission for Africa (UNECA) published a major report on industrialization in Africa where it asserts that structural transformation in Africas economies remains the highest priority and industrialization is the top strategy for achieving it in practice.
And, Belay says, biotechnology is one of the major tools for achieving industrialisation.
Im convinced that biotechnology has many opportunities to drive Africas industrialisation, he says.
We have Bt cotton, Bt maize and soya and biotechnology can enhance the competitiveness of our crops and agricultural products especially when it comes to value addition and beneficiation as it was stipulated in our African industrialisation agenda.
Already we are seeing the benefits of adopting biotech crops in South Africa. Livestock feed sectors in Zambia and even Zimbabwe cannot compete with SAs GM stock feed which is produced cheaply. We need to adopt this new technology to cut costs.
Europe relies heavily on GM soya for its livestock feed industry and this has enhanced its competitiveness.
Africa has a low uptake of biotech food crops due to lack of awareness and stiff resistance, scientists say.
International Service for the Acquisition of Agri-Biotech Applications (ISAAA) AfriCenter director Margaret Karembu told journalists at the workshop that adoption of agricultural biotechnology has lagged behind compared to the rapid rates seen in the medical and health sectors.
Where are we as Africans? This is the question, we need to think seriously about the good work (on agricultural biotechnology) going on in our labs, she said. What is our place in the global biotechnology space? We need reclaim it and improve the livelihoods of our farmers across the continent.
Karembu said lack of awareness and a constrained regulatory environment had also slowed down the uptake of agricultural biotechnology.
Lack of awareness of the benefits and the regulatory framework has affected the tide towards the adoption of biotechnology. The victim mentality has been largely to blame for this.
We think of ourselves as victims of the technology. The fact is that our public institutions and universities have been doing research on biotech crops for years and this has not moved to the commercialization stage, she says. She says Africa needs to diffuse myths and misconceptions around GMO crops.
The media has a big role to play in clearing some of the misconceptions about biotechnology and GMOs, the ISAAA director says.
When media demonises the science, it becomes difficult to correct the mistakes. There is a lot of unfamiliarity with the technology and having fixed mind sets will not help our struggling farmers.
The farmers you saw in Salima are poor and they are struggling. Why should we block them from accessing the Bt cotton varieties that can significantly boost their yields and income? Farming should not be for leisure, its a business and it should be there to improve the quality of livelihoods of the farmers.
Biotechnology is one of the tools we can use to first of all improve crop yields and secondly to support Africas industrialisation goals for value addition and beneficiation.
Karembu urged the media to encourage dialogue and to correct misinformation.
The information we generate should be guided by credible scientific evidence and not unverified Google information, she says. If you have a headache people just Google and Google has become the answer. The world is polluted by a lot of unsubstantiated facts. We need to change the narrative and challenge the myth that Africa enjoys being poor the romanticisation of poverty.
Stringent and expensive regulatory process in Africa has slowed down uptake of biotechnology crops.
Biotech experts say the regulatory process is burdensome and makes everything unpredictable while in some African countries there is fear of change and challenging of the status quo when it comes to biotechnology.
According to ISAAA, the production of biotech crops increased 110-fold from 1996 with countries now growing the crops on 2,1 billion hectares worldwide.
The global value of the biotech seed market alone was US$15,8 billion in 2016. A total of 26 countries, 19 developing and 7 industrial grew biotech crops.
By 2016, at least four countries in Africa had in the past placed a GM crop on the market. These included Egypt, South Africa, Burkina Faso and Sudan.
But due to some temporary setback in Burkina Faso and Egypt, only South Africa and Sudan planted biotech crops on 2,8 million hectares
South Africa is one of the top 10 countries planting more than one million hectares in 2016 and continued to lead the adoption of biotech crops on the African continent.
Kenya, Malawi and Nigeria have transitioned from research to granting environmental release approvals while six others Burkina Faso, Ethiopia, Ghana, Nigeria, Swaziland and Uganda made significant progress towards completion of multi-location trials in readiness for considering commercial approval, ISAAA reported.
But the road to the adoption of Bt cotton technologies in Africa still faces stiff resistance.
Supporters of GM crops have to grapple with vocal anti-GMO activists, limited capacity to deal with the processing of GM research applications, bureaucratic delays in approving field trials, mistrust and resistance from key decision makers in Government and limited public awareness of the issues surrounding research and development of GM crops.
In addition, they have to contend with issues related to disease resistance, bottlenecks encountered when co-ordinating with other line ministries, trade-related restrictions, biosafety regulation and the overwhelming influence of multinational companies, Governments and their sidekicks NGOs. And, despite the threats, biotechnology experts say benefits from the biotech agro-linked industrial development outweigh the threats.
SADC drew up its Industrialisation Strategy and Roadmap which seeks to speed up industrialisation by strengthening the comparative and competitive advantages of the economies of the region.
The strategy which covers the period 2015 2063 is anchored on three pillars industrialisation, competitiveness and regional industrialisation.
The whole industrialisation agenda aims to help SADC member states to achieve high levels of economic growth, competitiveness, incomes and employment.
To access the funds, SADC countries have set up committees made up of government and private sector players to identify priority areas for funding.
At regional level, three areas have been prioritised, namely agro processing, mining and downstream processing.
For all this, biotechnology could be a useful tool to drive the regions industrialisation agenda, Belay says.
Its not a silver bullet, but its one of the many tools we can use to drive the continents industrialisation strategy. Agriculture is fundamental to Comesa member states in terms of improving food and nutrition security, increasing rural income, employment and contributions to GDP and expert earnings.
We need to explore ways of enhancing the use of biotechnology to drive industrialisation and improved livelihoods for farmers in Africa.
Analysts say Africa badly needs increased investment in infrastructure of all kinds reliable clean energy and water systems, medical clinics, technical colleges, railways, roads, bridges, fiber optic networks, and factories of many kinds.
Industrialisation can benefit the expansion of intra-African trade by supporting a more diversified export economy, wrote an economic analyst.
In particular, the development of rural and food processing industries could help to lift significant numbers from poverty. But, to facilitate trade in goods and services, it is essential to reduce distribution costs by improving and expanding road, rail and other communication infrastructure. -Zimpapers Syndication
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ASA Provides Input to USDA, FDA on Advances in Biotechnology – KTIC
Posted: June 17, 2017 at 9:42 am
The American Soybean Association (ASA) submitted comments this week to both the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA) regarding regulations in response to advances in genetic engineering.
ASA included in comments to USDA, that biotechnology is an essential tool in farmers quest to produce enough food to meet the needs of 9.7 billion people by 2050, creating the need for a clear, science-based regulatory system in the U.S. as an example and standard for regulatory systems of biotechnology internationally.
While applauding USDAs efforts to reduce the burden on regulated entities, ASA expressed concern that aspects of the rule as proposed will increase the regulatory burden and stifle research and innovation.
Additionally, ASAs comments to FDA cheered USDAs proposal to exclude certain genome-editing techniques from requiring pre-market approvals because they are low risk and could be found in nature or achieved through traditional breeding methods.
ASA concluded its support saying, Technological advancements such as genome editing offer an additional tool to combat threats while also improving sustainability in production agriculture.
Full comments to USDA and FDA can be found here and here, respectively.
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$10M for birthplace of biotechnology – Innovators Magazine
Posted: June 17, 2017 at 9:42 am
(CALIFORNIA)
Thebirthplace of biotechnology is to receive$10 million for a pioneering precision medicine programme.
It was announced this week thatthe California Initiative to Advance Precision Medicine (CIAPM) has been awarded the money from the local governments budget, a decision welcomed by theCalifornia Life Sciences Association (CLSA).
Sara Radcliffe, President & CEO, CLSA, said:California Life Sciences Association (CLSA) applauds Governor Jerry Brown, California State Senate and California Assembly leaders for their strong support of life sciences innovation, as demonstrated again in this years 2017-2018 budget deal which allocates a $10 million investment in precision medicine research. California is the birthplace of biotechnology and today the states life sciences sector employs over 287,200 people working to develop innovative new medicines, technologies and therapies needed to treat and cure patients.
The Californian city of San Diego ishostingtheBIO International Conventionalthe global event for biotechnology next week. It will celebrate the industrys many breakthroughs and on going impact on society.It will take place at the San Diego Convention Center between 19 and 22 June.
BIO International ConventionalCalifornia Initiative to Advance Precision Medicine
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$10M for birthplace of biotechnology - Innovators Magazine
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This Biotechnology Company Wants to Reanimate the Brain-Dead – TrendinTech
Posted: June 15, 2017 at 9:42 pm
Ira Pastor, CEO of Bioquark, a Philadelphia-based biotechnology company, believes we will on day be able to reset the brain of patients declared brain-dead using a series of stem cell injections and nerve stimulations.
Until recently, death was medically defined as a loss of heart and lung function but as medical technology has advanced so has the qualifications. Now, since both heartbeat and breathing functions can be performed for a patient by machine, death is almost universally declared when there is a loss of activity in the brain stem. However, Pastor does think that this loss of brain function is as irreversible as weve come expect.
Initially, Bioquark was slated to start trials for the procedure last year in India but, due to strong opposition by the Indian Council of Medical Research, those studies were canceled. Nevertheless, Ira Pastor and his collaborator Himanshu Bansal, an orthopedic surgeon, remain undaunted and have announced a new series of test to happen soon in a nameless South American country.
Although they have not released the details of the revolutionary procedure, we can gather a general idea of their plan to reanimate the brain-dead from the papers regarding their original canceled trial.
Originally, the researchers wanted brain-dead subjects between the ages of 12 and 65. Ideally, the cause of the brain damage would be due to traumatic injury. Scientists would look at MRIs to determine eligibility, then brain cells would be harvested from the patients blood. After the stem cells are injected, the patients would get another injection, this time peptides, directly to the spinal column. The series of injections is followed by two weeks of nerve stimulation, specifically the median nerve, by lasers, which Bioquark thinks is the key to reversing brain death.
Bioquark has not clarified how it intends to obtain consent from technically dead patients but in spite of the controversy, this study is not alone. The work at Bioquark is part of a larger program concerning neuro-reanimation and regeneration called ReAnima.
Pastor, who also serves on the advisory board for the project, told the Daily Mail: The mission of the ReAnima Project is to focus on clinical research in the state of brain death, or irreversible coma, in subjects who have recently met the Uniform Determination of Death Act criteria, but who are still on cardio-pulmonary or trophic support a classification in many countries around the world known as a living cadaver.
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Biotechnology expert proposed for top Chinese University of Hong Kong post – South China Morning Post
Posted: June 15, 2017 at 9:42 pm
An internationally renowned biotechnology scientist, Professor Rocky Tuan Sung-chi, has been recommended to succeed Joseph Sung Jao-yiu as Chinese University vice-chancellor.
Born in Hong Kong and educated in the United States, Tuan is currently working at the University of Pittsburgh as director of the institutions cellular and molecular engineering lab, executive vice-chairman of the Department of Orthopaedic Surgery and a professor in the Department of Bioengineering.
He has been serving as a distinguished visiting professor and director of the Institute for Tissue Engineering and Regenerative Medicine at Chinese University.
The institutions council said on Thursday that it would recommend Tuan to be the next vice-chancellor. It will hold a consultation of up to six weeks with staff, students and alumni, but the universitys teachers association vowed to boycott it, saying the council had fooled it by saying it was not sure who the candidate was.
In May 2016, Tuan was one of the 10 Carnegie Science Award winners for his extensive experience in applying adult stem cells for tissue engineering and regenerative medicine.
Hes a good scientist, professionally speaking, with a major interest in bone and tendon regeneration, Professor Chan Wai-yee of the universitys School of Biomedical Sciences said. He used to chair the biology and medicine panel of the Research Grants Council so he should know better than others what improvements can be made to develop Hong Kongs scientific research.
I have high expectations of him. As a successful scholar who has worked for the Research Grants Council for so many years, he could at least reflect our wish for more funding and resources.
However, Professor Chan King-ming, president of the Chinese University Teachers Association, said he was angry about the announcement and that staff and students were being played by the universitys top administration, who two weeks ago told the association they were still not sure about the candidate.
Chan King-ming also said Tuan lacked outstanding academic status and administrative experience. Seldom were his papers published by top journals and he has never served at the level of deputy vice-chancellor or dean in any university, the biochemistry scholar said.
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Vontobel Swiss Wealth Advisors AG Acquires 4956 Shares of iShares Nasdaq Biotechnology Index Fund (IBB) – The Cerbat Gem
Posted: June 15, 2017 at 9:42 pm
Vontobel Swiss Wealth Advisors AG Acquires 4956 Shares of iShares Nasdaq Biotechnology Index Fund (IBB) The Cerbat Gem iShares Nasdaq Biotechnology Index Fund logo Vontobel Swiss Wealth Advisors AG increased its position in shares of iShares Nasdaq Biotechnology Index Fund (NASDAQ:IBB) by 36.0% during the first quarter, according to its most recent 13F filing with the ... Ken Stern & Associates Inc. Has $318000 Stake in iShares Nasdaq Biotechnology Index Fund (IBB) iShares Nasdaq Biotechnology Index Fund - Receive News & Ratings Daily The Traders Buy Large Volume of Put Options on iShares Nasdaq Biotechnology Index Fund (IBB) |
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Vontobel Swiss Wealth Advisors AG Acquires 4956 Shares of iShares Nasdaq Biotechnology Index Fund (IBB) - The Cerbat Gem
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Biotechnology company opens mosquito factory in Lexington – Lexington Herald Leader
Posted: June 14, 2017 at 8:46 pm
Lexington Herald Leader | Biotechnology company opens mosquito factory in Lexington Lexington Herald Leader A Lexington biotechnology company aimed at fighting mosquito-borne diseases such as the Zika virus opened a mosquito factory Friday on Malabu Drive. MosquitoMate, a biotechnology company founded by University of Kentucky entomology professor ... |
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Biotechnology FAQs | USDA
Posted: June 14, 2017 at 4:48 am
1. What is Agricultural Biotechnology?
Agricultural biotechnology is a range of tools, including traditional breeding techniques, that alter living organisms, or parts of organisms, to make or modify products; improve plants or animals; or develop microorganisms for specific agricultural uses. Modern biotechnology today includes the tools of genetic engineering.
2. How is Agricultural Biotechnology being used?
Biotechnology provides farmers with tools that can make production cheaper and more manageable. For example, some biotechnology crops can be engineered to tolerate specific herbicides, which make weed control simpler and more efficient. Other crops have been engineered to be resistant to specific plant diseases and insect pests, which can make pest control more reliable and effective, and/or can decrease the use of synthetic pesticides. These crop production options can help countries keep pace with demands for food while reducing production costs. A number of biotechnology-derived crops that have been deregulated by the USDA and reviewed for food safety by the Food and Drug Administration (FDA) and/or the Environmental Protection Agency (EPA) have been adopted by growers.
Many other types of crops are now in the research and development stages. While it is not possible to know exactly which will come to fruition, certainly biotechnology will have highly varied uses for agriculture in the future. Advances in biotechnology may provide consumers with foods that are nutritionally-enriched or longer-lasting, or that contain lower levels of certain naturally occurring toxicants present in some food plants. Developers are using biotechnology to try to reduce saturated fats in cooking oils, reduce allergens in foods, and increase disease-fighting nutrients in foods. They are also researching ways to use genetically engineered crops in the production of new medicines, which may lead to a new plant-made pharmaceutical industry that could reduce the costs of production using a sustainable resource.
Genetically engineered plants are also being developed for a purpose known as phytoremediation in which the plants detoxify pollutants in the soil or absorb and accumulate polluting substances out of the soil so that the plants may be harvested and disposed of safely. In either case the result is improved soil quality at a polluted site. Biotechnology may also be used to conserve natural resources, enable animals to more effectively use nutrients present in feed, decrease nutrient runoff into rivers and bays, and help meet the increasing world food and land demands. Researchers are at work to produce hardier crops that will flourish in even the harshest environments and that will require less fuel, labor, fertilizer, and water, helping to decrease the pressures on land and wildlife habitats.
In addition to genetically engineered crops, biotechnology has helped make other improvements in agriculture not involving plants. Examples of such advances include making antibiotic production more efficient through microbial fermentation and producing new animal vaccines through genetic engineering for diseases such as foot and mouth disease and rabies.
3. What are the benefits of Agricultural Biotechnology?
The application of biotechnology in agriculture has resulted in benefits to farmers, producers, and consumers. Biotechnology has helped to make both insect pest control and weed management safer and easier while safeguarding crops against disease.
For example, genetically engineered insect-resistant cotton has allowed for a significant reduction in the use of persistent, synthetic pesticides that may contaminate groundwater and the environment.
In terms of improved weed control, herbicide-tolerant soybeans, cotton, and corn enable the use of reduced-risk herbicides that break down more quickly in soil and are non-toxic to wildlife and humans. Herbicide-tolerant crops are particularly compatible with no-till or reduced tillage agriculture systems that help preserve topsoil from erosion.
Agricultural biotechnology has been used to protect crops from devastating diseases. The papaya ringspot virus threatened to derail the Hawaiian papaya industry until papayas resistant to the disease were developed through genetic engineering. This saved the U.S. papaya industry. Research on potatoes, squash, tomatoes, and other crops continues in a similar manner to provide resistance to viral diseases that otherwise are very difficult to control.
Biotech crops can make farming more profitable by increasing crop quality and may in some cases increase yields. The use of some of these crops can simplify work and improve safety for farmers. This allows farmers to spend less of their time managing their crops and more time on other profitable activities.
Biotech crops may provide enhanced quality traits such as increased levels of beta-carotene in rice to aid in reducing vitamin A deficiencies and improved oil compositions in canola, soybean, and corn. Crops with the ability to grow in salty soils or better withstand drought conditions are also in the works and the first such products are just entering the marketplace. Such innovations may be increasingly important in adapting to or in some cases helping to mitigate the effects of climate change.
The tools of agricultural biotechnology have been invaluable for researchers in helping to understand the basic biology of living organisms. For example, scientists have identified the complete genetic structure of several strains of Listeria and Campylobacter, the bacteria often responsible for major outbreaks of food-borne illness in people. This genetic information is providing a wealth of opportunities that help researchers improve the safety of our food supply. The tools of biotechnology have "unlocked doors" and are also helping in the development of improved animal and plant varieties, both those produced by conventional means as well as those produced through genetic engineering.
4. What are the safety considerations with Agricultural Biotechnology?
Breeders have been evaluating new products developed through agricultural biotechnology for centuries. In addition to these efforts, the United States Department of Agriculture (USDA), the Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA) work to ensure that crops produced through genetic engineering for commercial use are properly tested and studied to make sure they pose no significant risk to consumers or the environment.
Crops produced through genetic engineering are the only ones formally reviewed to assess the potential for transfer of novel traits to wild relatives. When new traits are genetically engineered into a crop, the new plants are evaluated to ensure that they do not have characteristics of weeds. Where biotech crops are grown in proximity to related plants, the potential for the two plants to exchange traits via pollen must be evaluated before release. Crop plants of all kinds can exchange traits with their close wild relatives (which may be weeds or wildflowers) when they are in proximity. In the case of biotech-derived crops, the EPA and USDA perform risk assessments to evaluate this possibility and minimize potential harmful consequences, if any.
Other potential risks considered in the assessment of genetically engineered organisms include any environmental effects on birds, mammals, insects, worms, and other organisms, especially in the case of insect or disease resistance traits. This is why the USDA's Animal and Plant Health Inspection Service (APHIS) and the EPA review any environmental impacts of such pest-resistant biotechnology derived crops prior to approval of field-testing and commercial release. Testing on many types of organisms such as honeybees, other beneficial insects, earthworms, and fish is performed to ensure that there are no unintended consequences associated with these crops.
With respect to food safety, when new traits introduced to biotech-derived plants are examined by the EPA and the FDA, the proteins produced by these traits are studied for their potential toxicity and potential to cause an allergic response. Tests designed to examine the heat and digestive stability of these proteins, as well as their similarity to known allergenic proteins, are completed prior to entry into the food or feed supply. To put these considerations in perspective, it is useful to note that while the particular biotech traits being used are often new to crops in that they often do not come from plants (many are from bacteria and viruses), the same basic types of traits often can be found naturally in most plants. These basic traits, like insect and disease resistance, have allowed plants to survive and evolve over time.
5. How widely used are biotechnology crops?
According to the USDA's National Agricultural Statistics Service (NASS), biotechnology plantings as a percentage of total crop plantings in the United States in 2012 were about 88 percent for corn, 94 percent for cotton, and 93 percent for soybeans. NASS conducts an agricultural survey in all states in June of each year. The report issued from the survey contains a section specific to the major biotechnology derived field crops and provides additional detail on biotechnology plantings. The most recent report may be viewed at the following website: https://www.ers.usda.gov/data-products/adoption-of-genetically-engineered-crops-in-the-us.aspx
For a summary of these data, see the USDA Economic Research Service data feature at: https://www.ers.usda.gov/data-products/adoption-of-genetically-engineered-crops-in-the-us.aspx
The USDA does not maintain data on international usage of genetically engineered crops. The independent International Service for the Acquisition of Agri-biotech Applications (ISAAA), a not-for-profit organization, estimates that the global area of biotech crops for 2012 was 170.3 million hectares, grown by 17.3 million farmers in 28 countries, with an average annual growth in area cultivated of around 6 percent. More than 90 percent of farmers growing biotech crops are resource-poor farmers in developing countries. ISAAA reports various statistics on the global adoption and plantings of biotechnology derived crops. The ISAAA website is https://www.isaaa.org
6. What are the roles of government in agricultural biotechnology?
Please note: These descriptions are not a complete or thorough review of all the activities of these agencies with respect to agricultural biotechnology and are intended as general introductory materials only. For additional information please see the relevant agency websites.
Regulatory
The Federal Government developed a Coordinated Framework for the Regulation of Biotechnology in 1986 to provide for the regulatory oversight of organisms derived through genetic engineering. The three principal agencies that have provided primary guidance to the experimental testing, approval, and eventual commercial release of these organisms to date are the USDA's Animal and Plant Health Inspection Service (APHIS), the Environmental Protection Agency (EPA), and the Department of Health and Human Services' Food and Drug Administration (FDA). The approach taken in the Coordinated Framework is grounded in the judgment of the National Academy of Sciences that the potential risks associated with these organisms fall into the same general categories as those created by traditionally bred organisms.
Products are regulated according to their intended use, with some products being regulated under more than one agency. All government regulatory agencies have a responsibility to ensure that the implementation of regulatory decisions, including approval of field tests and eventual deregulation of approved biotech crops, does not adversely impact human health or the environment.
The Animal and Plant Health Inspection Service (APHIS) is responsible for protecting U.S. agriculture from pests and diseases. APHIS regulations provide procedures for obtaining a permit or for providing notification prior to "introducing" (the act of introducing includes any movement into or through the U.S., or release into the environment outside an area of physical confinement) a regulated article in the U.S. Regulated articles are organisms and products altered or produced through genetic engineering that are plant pests or for which there is reason to believe are plant pests.
The regulations also provide for a petition process for the determination of non-regulated status. Once a determination of non-regulated status has been made, the organism (and its offspring) no longer requires APHIS review for movement or release in the U.S.
For more information on the regulatory responsibilities of the FDA, the EPA and APHIS please see:
APHIS Biotechnology Regulations
Market Facilitation
The USDA also helps industry respond to consumer demands in the United States and overseas by supporting the marketing of a wide range of agricultural products produced through conventional, organic, and genetically engineered means.
The Agricultural Marketing Service (AMS) and the Grain Inspection, Packers, and Stockyards Administration (GIPSA) have developed a number of services to facilitate the strategic marketing of conventional and genetically engineered foods, fibers, grains, and oilseeds in both domestic and international markets. GIPSA provides these services for the bulk grain and oilseed markets while AMS provides the services for food commodities such as fruits and vegetables, as well as for fiber commodities.
These services include:
1. Evaluation of Test Kits: AMS and GIPSA evaluate commercially available test kits designed to detect the presence of specific proteins in genetically engineered agricultural commodities. The agencies confirm whether the tests operate in accordance with manufacturers' claims and, if the kits operate as stated, the results are made available to the public on their respective websites.
GIPSA Link: https://www.gipsa.usda.gov/fgis/rapidtestkit.aspx
GIPSA evaluates the performance of laboratories conducting DNA-based tests to detect genetically engineered grains and oilseeds, provides participants with their individual results, and posts a summary report on the GIPSA website. AMS is developing a similar program that can evaluate and verify the capabilities of independent laboratories to screen other products for the presence of genetically engineered material.
2. Identity Preservation/Process Verification Services: AMS and GIPSA offer auditing services to certify the use of written quality practices and/or production processes by producers who differentiate their commodities using identity preservation, testing, and product branding.
GIPSA Link: https://www.gipsa.usda.gov/fgis/inspectionweighing.aspx
AMS Link: https://www.ams.usda.gov/fv/ipbv.htm
Additional AMS Services: AMS provides fee-based DNA and protein testing services for food and fiber products, and its Plant Variety Protection Office offers intellectual property rights protection for new genetically engineered seed varieties through the issuance of Certificates of Protection.
Additional GIPSA Services: GIPSA provides marketing documents pertaining to whether there are genetically engineered varieties of certain bulk commodities in commercial production in the United States. USDA also works to improve and expand market access for U.S. agricultural products, including those produced through genetic engineering.
The Foreign Agricultural Service (FAS) supports or administers numerous education, outreach, and exchange programs designed to improve the understanding and acceptance of genetically engineered agricultural products worldwide
1. Market Access Program and Foreign Market Development Program: Supports U.S. farm producer groups (called "Cooperators") to market agricultural products overseas, including those produced using genetic engineering.
2. Emerging Markets Program: Supports technical assistance activities to promote exports of U.S. agricultural commodities and products to emerging markets, including those produced using genetic engineering. Activities to support science-based decision-making are also undertaken. Such activities have included food safety training in Mexico, a biotechnology course for emerging market participants at Michigan State University, farmer-to-farmer workshops in the Philippines and Honduras, high-level policy discussions within the Asia-Pacific Economic Cooperation group, as well as numerous study tours and workshops involving journalists, regulators, and policy-makers.
3. Cochran Fellowship Program: Supports short-term training in biotechnology and genetic engineering. Since the program was created in 1984, the Cochran Fellowship Program has provided education and training to 325 international participants, primarily regulators, policy makers, and scientists.
4. Borlaug Fellowship Program: Supports collaborative research in new technologies, including biotechnology and genetic engineering. Since the program was established in 2004, the Borlaug Fellowship Program has funded 193 fellowships in this research area.
5. Technical Assistance for Specialty Crops (TASC): Supports technical assistance activities that address sanitary, phytosanitary, and technical barriers that prohibit or threaten the export of U.S. specialty crops. This program has supported activities on biotech papaya.
Research
USDA researchers seek to solve major agricultural problems and to better understand the basic biology of agriculture. Researchers may use biotechnology to conduct research more efficiently and to discover things that may not be possible by more conventional means. This includes introducing new or improved traits in plants, animals, and microorganisms and creating new biotechnology-based products such as more effective diagnostic tests, improved vaccines, and better antibiotics. Any USDA research involving the development of new biotechnology products includes biosafety analysis.
USDA scientists are also improving biotechnology tools for ever safer, more effective use of biotechnology by all researchers. For example, better models are being developed to evaluate genetically engineered organisms and to reduce allergens in foods.
USDA researchers monitor for potential environmental problems such as insect pests becoming resistant to Bt, a substance that certain crops, such as corn and cotton, have been genetically engineered to produce to protect against insect damage. In addition, in partnership with the Agricultural Research Service (ARS) and the Forest Service, the Cooperative States Research, the National Institute of Food and Agriculture (NIFA) administers the Biotechnology Risk Assessment Research Grants Program (BRAG) which develops science-based information regarding the safety of introducing genetically engineered plants, animals, and microorganisms. Lists of biotechnology research projects can be found at https://www.ars.usda.gov/research/projects.htm for ARS and at https://www.nifa.usda.gov/funding-opportunity/biotechnology-risk-assessment-research-grants-program-brag for NIFA.
USDA also develops and supports centralized websites that provide access to genetic resources and genomic information about agricultural species. Making these databases easily accessible is crucial for researchers around the world.
USDA's National Institute of Food and Agriculture (NIFA) provides funding and program leadership for extramural research, higher education, and extension activities in food and agricultural biotechnology. NIFA administers and manages funds for biotechnology through a variety of competitive and cooperative grants programs. The National Research Initiative (NRI) Competitive Grants Program, the largest NIFA competitive program, supports basic and applied research projects and integrated research, education, and/or extension projects, many of which use or develop biotechnology tools, approaches, and products. The Small Business Innovation Research Program (SBIR) funds competitive grants to support research by qualified small businesses on advanced concepts related to scientific problems and opportunities in agriculture, including development of biotechnology-derived products. NIFA also supports research involving biotechnology and biotechnology-derived products through cooperative funding programs in conjunction with state agricultural experiment stations at land-grant universities. NIFA partners with other federal agencies through interagency competitive grant programs to fund agricultural and food research that uses or develops biotechnology and biotechnology tools such as metabolic engineering, microbial genome sequencing, and maize genome sequencing.
USDA's Economic Research Service (ERS) conducts research on the economic aspects of the use of genetically engineered organisms, including the rate of and reasons for adoption of biotechnology by farmers. ERS also addresses economic issues related to the marketing, labeling, and trading of biotechnology-derived products.
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New Master’s Program Prepares Leaders in Biotechnology – Azusa Pacific University
Posted: June 12, 2017 at 4:42 pm
Preparing competent, competitive, and ethical leaders, Azusa Pacifics new Master of Science in Biotechnology equips graduates to make significant contributions to and profoundly influence this emerging science field. Set to launch in fall 2017 with a cohort of 24, the advanced degree distinguishes itself from counterparts at other institutions by approaching the discipline from a distinctly Christian worldview and instilling in students the ability to synthesize human need, potential, and responsibility.
Graduates with this level of training find a wide-open marketplace eager to hire. Jobs in the biomedical industry show an upward trend throughout the country, and particularly in California, home to more than 50 percent of these companies. According to a 2014 report from Genetic Engineering and Biotechnology News, the industry expects significant job growth over the next decade in the areas of epidemiology, bioinformatics and genetic counseling, microbiology, biomedical engineering, and biomedical research. Nestled in the heart of the countrys second-largest cluster of bioscience businesses, APU offers students a distinct advantage that surpasses traditional internships and networking. A collaborative enterprise, this program partners APU with local bioscience companies, including Grifols Biologicals, Gilead Sciences, Johnson & Johnson, Allergan, and others. In addition to technical proficiency, APUs program also provides industry-critical skills, such as project and program management, communication skills, teamwork, business ethics, and leadership, which produces graduates who are productive employees on the first day of hire in a corporate setting.
Open to students and professionals with bachelors degrees in molecular or cellular biology, biochemistry, applied mathematics, statistics, engineering, or computer science, the M.S. in Biotechnology offers a unique approach to the field through the lens of Christian faith and imparts a clear understanding of how believers can participate in and provide guidance to the industry in a way that advances science and glorifies God.
Posted: June 12, 2017
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New Master's Program Prepares Leaders in Biotechnology - Azusa Pacific University
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