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Posts Tagged ‘GMO regulation

How GMOs Could Help with Sustainable Food Production

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By: Agnes Donko, PhD

World Population estimates from 1800 to 2100

           The world population has exceeded 7.5 billion and by 2050 it is expected to reach 9.7 billion. The challenge of feeding this ever-growing population is exacerbated by global warming, which may lead to more frequent droughts or the melting of Arctic sea and Greenland ice. The year 2016 was the warmest ever recorded, with the average temperature 1.1 °C above the pre-industrial period, and 0.06 °C above the previous record set in 2015. According to the United Nations, the world faces the largest humanitarian crisis in East-Africa since the foundation of the organization in 1945, particularly in Yemen, South Sudan, Somalia and Nigeria. In these countries, 20 million people face starvation and famine this year because of drought and regional political instability.

How could genetically modified organisms (GMO) help?

The two main GMO strategies  are the herbicide-tolerant (HT) and insect-resistant crops. HT crops were developed to help crops survive application of specific herbicides (glyphosate) that would otherwise destroy the crop along with the targeted weeds. Insect-resistant crops contain a gene from the soil bacterium Bt (Bacillus thuringiensis) that encodes for a protein that is toxic to specific insects, thus protecting the plant. Insect-resistant crops can reduce pesticide use, which decreases the ecological footprint of cultivation in two ways – first by reducing insecticide use, which in turn will reduce the environmental impact of insecticide production, and second by reducing the fuel usage and carbon dioxide (greenhouse gas) emission, by fewer spraying rounds and reduced tillage. Thus, adoption of GM technology by African nations and other populous countries like India could help with sustainable agriculture that can ameliorate the burden of changing climate and growing populations.

In developed nations, especially in the US, GM technology has been widely used since the mid-1990s, mainly in four crops: canola, maize, cotton and soybean. GM crops account for 93 percent of cotton, 94 percent of soybean and 92 percent of corn acreage in the US in 2016. Although the appearance of weed resistance to glyphosate increased herbicide usage, in 2015 the global insecticide savings from using herbicide-tolerant maize and cotton were 7.8 million kg (84% decrease) and 19.3 million kg (53% decrease), respectively, when compared with pesticide usage expected with conventional crops. Globally these savings resulted in more than 2.8 million kg of carbon dioxide, which is equivalent to taking 1.25 million cars off the road for one year.

Another way in which GM crops can help sustainable food production is by reducing food wastage in developed nations. The Food and Agriculture Organization of the United Nations (FAO) estimates that one-third of all food produced for human consumption in the world (around 1.3 billion tons) is lost or wasted each year, which includes 45% of all fruits. For example, when an apple is bruised, an enzyme called polyphenol oxidase initiates the degradation of polyphenols that turns the apple’s flesh brown. But nobody wants to buy brown apples, so the bruised apples are simply trashed. In Arctic apples, the level of the enzyme is reduced by gene silencing, thereby preventing browning. The Arctic Apple obtained USDA approval in 2015, and is expected to reach the market in 2017.

In 2015, the FDA approved the first GMO food for animal consumption, a genetically modified Atlantic salmon called AquAdvantage. Conventional salmon farming has terrible effects on the environment. However, AquAdvantage contains a growth hormone regulating transgene, which allows for accelerated growth rates, thus decreasing the farming time from 3 years to 16-18 months. This would dramatically reduce the ecological footprint of fish farming, leading to more sustainable food production. Even though FDA did not find any difference in the nutritional profile between AquAdvantage and its natural counterpart, AquAdvantage will not hit the U.S. market any time soon, because the FDA banned import and sale until the exact guidelines on how this product should be labelled are published.

This FDA action was initiated by bill S. 764 that was signed by former president Barack Obama in 2016. Bill S. 764 requires food companies to disclose GMOs without necessarily using a GMO text label on packaging. They may choose to label GM ingredients with a symbol or a QRC (quick response code) that, when scanned by a smartphone, will lead the consumer to a website with more information on the product. But this requires the consumer to have both a smartphone and access to the internet. The bill also has ‘lax standards and broad definition’. For instance, if the majority of a product contains meat, but some other less significant ingredient is produced from GM crops, then it need not be labelled. Oil extracted from GM soybean, or starch purified from GM corn are exempt from labeling, because they were only derived from GM sources, but no longer contain any genetic material in them. Contrarily, in the European Union (EU), regulations require that the phrase “genetically modified” or “produced from genetically modified [name of the organism]” must appear clearly next to the ingredient list. If the food is not packaged, the same phrase must be on the food display or next to it. The EU also unequivocally determines the level of GMO (below 0.9 %) in conventional food or feed that is exempt from labelling.

Despite its controversial guidelines for GMO labeling, bill S. 764 could end the long-fought battle of Just Label It campaign. The bill was a huge step toward the right to know, which will let individuals decide if they want to consume GM foods or not. GMOs can significantly support sustainable food production and reduce the destructive environmental impact of humanity, but only if we let it.

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Written by sciencepolicyforall

May 12, 2017 at 5:13 pm

Genetically Modified Animal Vectors to Combat Disease

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By: Sarah L Hawes, PhD

Mosquito larvae: ©ProjectManhattan via Wikimedia Commons

Diseases transmitted through contact with an animal carrier, or “vector,” cause over one million deaths annually, many of these in children under the age of five. More numerous, non-fatal cases incur a variety of symptoms ranging from fevers to lesions to lasting organ damage. Vector-borne disease is most commonly contracted from the bite of an infected arthropod, such as a tick or mosquito. Mosquito-borne Zika made recent, regular headlines following a 2015-2016 surge in birth defects among infants born to women bitten during pregnancy. Other big names in vector-borne disease include Malaria, Dengue, Chagas disease, Leishmaniasis, Rocky Mountain spotted fever and Lyme.

Vaccines do not exist for many of these diseases, and the Centers for Disease Control (CDC) Division of Vector-Borne Diseases focuses on “prevention and control strategies that can reach the targeted disease or vector at multiple levels while being mindful of cost-effective delivery that is acceptable to the public, and cognizant of the world’s ecology.” Prevention through reducing human contact with vectors is classically achieved through a combination of physical barriers (i.e. bed nets and clothing), controlling vector habitat near humans (i.e. dumping standing water or mowing tall grass), and reducing vector populations with poisons. For instance, the Presidential Malaria Initiative (PMI), initiated under President Bush in 2005, and expanded under President Obama, reduces vector contact through a complement of educating the public, distributing and encouraging the use of bed nets, and spraying insecticide. Now a 600 million dollar a year program, PMI has been instrumental in preventing several million Malaria-related deaths in the last decade.

But what if a potentially safer, cheaper and more effective solution to reduce human-vector contact exists in the release of Genetically Modified (GM) vector species? Imagine a mosquito engineered to include a new or altered gene to confer disease resistance, sterility, or to otherwise impede disease transmission to humans. Release of GM mosquitos could drastically reduce the need for pesticides, which may be harmful to humans, toxic to off-target species, and have led to pesticide-resistance in heavily-sprayed areas. Health and efficacy aside, it is impossible to overturn or poison every leaf cupping rainwater where mosquitos breed. GM mosquitos could reach and “treat” the same pockets of water as their non-GM counterparts. However, an insect designed to pass on disease resistance to future generations would mean persistence of genetic modifications in the wild, which is worrisome given the possibility of unintended direct effects or further mutation. An elegant alternative is the release of GM vector animals producing non-viable offspring – and this is exactly what biotech company Oxitec has done with mosquitos.

Oxitec’s OX513A mosquitos express a gene that interferes with critical cellular functions in the mosquitos, but this gene is suppressed in captivity by administering the antibiotic tetracycline in the mosquitos’ diet. Release of thousands of non-biting OX513A males into the wild results in a local generation of larvae which, in the absence of tetracycline, die before reaching adulthood. Release of OX513A has proven successful at controlling mosquito populations in several countries since 2009, rapidly reducing local numbers by roughly 90%. Oxitec’s OX513A line may indeed be a safe and effective tool. But who is charged with making this call for OX513A and, moreover for future variations in GM vector release?

Policy governing use of genetically modified organisms must keep pace with globally available biotechnology. Regulatory procedures for the use of GM vector release are determined by country, and there is a high degree of international policy alignment. The Cartagena Protocol on Biosafety is a treaty involving 170 nations currently (the US not included) that governs transport of “living modified organisms resulting from modern biotechnology” with potential to impact environmental or human health. The World Health Organization (WHO) and the Foundation for the National Institutes of Health (FNIH) published the 2014 guidelines for evaluating safety and efficacy of GM mosquitos.

Within the US, the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology was published this January in response to a solicitation by the Executive Office of the President for a cohesive report from the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and US Department of Agriculture (USDA). Separately, biotech industry has been given fresh guidance on whether to seek FDA or EPA approval (in brief):  if your GM product is designed to reduce disease load or spread, including vector population reduction, it requires New Animal Drug approval by FDA; if it is designed to reduce pest population but is un-related to disease, it requires Pesticide Product approval by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act.

Thus, for a biotech company to release GM mosquitos in the US with the intent of curbing the spread of mosquito-borne disease, they must first gain FDA approval. Oxitec gained federal approval to release OX513A in a Florida suburb in August 2015 because of FDA’s “final environmental assessment (EA) and finding of no significant impact (FONSI).” These FDA assessments determined that the Florida ecosystem would not be harmed by eliminating the targeted, invasive Aedes aegypti mosquito. In addition, they affirmed that no method exists for the modified gene carried by OX513A to impact humans or other species. Risks were determined to be negligible, and include the accidental release of a few, disease-free OX513A females. For a human bitten by a rare GM female, there is zero risk of transgene transfer. There is no difference in saliva allergens, and therefore the response to a bite, from GM and non-GM mosquitos. In addition, as many as 3% of OX513A offspring manage to survive to adulthood, presumably by spawning in tetracycline-treated water for livestock. These few surviving offspring will not become a long-term problem because their survival is not a heritable loop-hole; it is instead analogous to a lucky few mosquitos avoiding contact with poison.

Solid scientific understanding of the nature of genetic modifications is key to the creation of good policy surrounding the creation and use of GMOs. In an updated draft of Guidelines For Industry 187 (GFI 187), the FDA advises industry seeking New Animal Drug Approval to include a molecular description of the intentional genetic alteration in animals, method for alteration, description of introduction to the animal, and whether the alteration is stable over time/across generations if heritable, and environmental and food safety assessments. Newer genomic DNA editing techniques such as CRISPR offer improved control over the location, and thus, the effect of genetic revisions. In light of this, the FDA is soliciting feedback from the public on the GFI 187 draft until April 19th, 2017, in part to determine whether certain types of genetic alteration in animals might represent no risk to humans or animals, and thus merit reduced federal regulation.

Following federal clearance, the decision on whether to release GM vectors rests with local government. Currently, lack of agreement among Florida voters has delayed the release of OX315A mosquitos. Similar to when GM mosquito release was first proposed in Florida following a 2009-2010 Dengue outbreak, voter concern today hinges on the perception that GM technology is “unproven and unnatural.” This illustrates both a healthy sense of skepticism in our voters, and the critical need to improve scientific education and outreach in stride with biotechnology and policy. Until we achieve better public understanding of GM organisms, including how they are created, controlled, and vetted, we may miss out on real opportunities to safely and rapidly advance public health.

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Written by sciencepolicyforall

February 16, 2017 at 9:46 am

Science Policy Around the Web – April 15, 2016

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By: Daniël P. Melters, Ph.D

Photo credit: Holly Pavlika at

Social health policy

Paid maternity leave reduces infant death

In developing nations, more generous maternity leave can save the lives of babies, according to a recent study in PLoS Medicine. The paper estimates that each extra month of maternity leave is linked to about eight fewer infant deaths for each 1,000 live births, or a reduction of 13% in infant mortality. The advantages of paid maternity leave are that mothers-to-be will be able to make use of health services before and after childbirth as their income and jobs are protected. It will also reduce anxiety in mother, improving her health besides that of her baby, the study says. Maternity leave also increase the likelihood that mothers will breastfeed their child and stick to vaccination schedules, potentially increasing the power of paid maternity leave.

Based on our analysis, I’m fairly convinced that increasing the duration of paid leave is an effective way to reducing infant mortality”, the lead author Nandi from McGill University says. He adds that his team controlled for other factors that reduce infant death, such as gross domestic product and national health spending. The researchers compared rates of infant death in two groups of low- and middle-income countries, covering 300,000 life births between 2000 and 2008.

Child health researcher Zulfiqar Bhutta from the University of Toronto is cautious about extrapolating the results from this study over all low- and middle-income countries. “The major limitation here is the assumption that maternity leave policies in a country are universally applied, which they are not.” A cautionary note that Nandi agrees with on the end of implementation, as they did not study this. He also points to research in other areas, which suggest that policies improving the conditions of employees tend to have spillover effects. (PLoS Medicine)

Gene-editing technology

Committee to study oversight of GMOs

The United States is revamping its rules for regulating GMOs, which collectively are known as the Coordinated Framework for Regulation of Biotechnology. To that end, the National Academies of Sciences have convened a committee that is charged with predicted what advances will be made in biotechnology products over the next 5-10 years. It will hold its first meeting on April 18th. To date, GMOs are regulated by three US agencies: US Food and Drug Administration (FDA), US Environmental Protection Agency (EPA), and US Department of Agriculture (USDA). The USDA’s Animal and Plant Health Inspection Service (APHIS) regulates any genetically engineered organisms that may pose a risk to plant health. In addition, GMOs may still undergo a voluntary review at the FDA (as Oxitec did with their GMO mosquito), or face oversight by the EPA.

Recently, the USDA allowed a mushroom that has been genetically modified with the new gene-editing technology CRISPR (removing several base-pairs knocking-out a gene responsible for browning) to allowed on the US market without going through a review process. It is one of about 30 GMOs to sidestep the USDA regulatory system in the past five years. In each case, the USDA deemed that each GMO did not qualify, as something the agency must regulate. In other words, the USDA itself acknowledges that it might be overregulating some crops if they have traits that have already been scrutinized.

This is of course not to say that no oversight is needed. The use of gene editing technology in humans is still controversial, especially in human embryos, as became clear again by a second study published by a Chinese group where they used CRISPR to alter human embryos, or the approval of project in the United Kingdom. New hurdles will be encountered as well. The successful removing of HIV from an HIV infected cell by CRISPR was hailed, but its success was short-lived as HIV found a way to outsmart the power of the current CRISPR technology. The fast moving pace at which gene-editing technology is developing and how its use if being exploited highlights the need for the US regulatory agencies to keep up with these chances both from economical growth as well as a public safety perspective. (Heidi Ledford, Nature)

Precision Medicine Initiative

Dishman to lead PMI Cohort

Dr. Francis Collins, the director of the National Institutes of Health, has announced that the permanent director of the Precision Medicine Initiative (PMI) Cohort Program will be Eric Dishman, taking over the helm from interim director Dr. Josephine Briggs. Dishman, 48, who now heads the Health and Life Sciences Group at Intel Corporation in Santa Clara, California, will start his new job next month. He is not an obvious choice to lead the cohort program as he does not have a background in genomics or large, long-term health studies, nor a PhD or MD degree. He does have a trove of knowledge about health technologies, which will play a key role in the PMI-cohort. At Intel, he oversaw research on devices to help Alzheimer’s patients and elderly living independently. Dishman also battled and overcome a rare type of kidney cancer at the age of 23. Several years ago he has his tumor sequences, which pointed to a treatment that might help save his life. According to Collins, Dishman is the right person to the lead PMI-Cohort program with his “wealth of health innovation experience … as a social scientist and researcher, entrepreneur and business leader, patient and patient advocate, and policy advocate and thought leader.” (Joselyn Kaiser, Science Insider)

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Written by sciencepolicyforall

April 15, 2016 at 1:00 pm