The USDA won’t regulate genetically edited plants

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The US Department of Agriculture has zero plans to regulate plants altered with gene-editing technologies, according to the agency's Secretary Sonny Perdue. It won't prevent the release of crops created using CRISPR, for instance, so long as the fina…
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Changing Regulations Mean Genetically Modified Meat Could Soon Be on Your Plate

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Low-fat pigs? Chickens with cancer-fighting eggs?

It’s no longer surprising to hear that scientists have figured out how to alter animals in new, creative ways — that’s how precise genetic engineering has become.

But you also might have noticed that this news pretty much never goes beyond the laboratory. As of yet, there has only been a single genetically engineered animal that’s made it to the dinner plate (a salmon, in Canada). In the U.S., a complex regulatory process from the Food and Drug Administration (FDA) has hindered those who wanted to bring gene-edited (GE) livestock to market.

But if industry officials have their way, that won’t be the case much longer.

MIT Technology Review reports that gene editing companies and biotechnology lobbyists are trying to convince the Trump administration to move the regulation of GE animals to the U.S. Department of Agriculture (USDA). If that happens, genetically modified meat might soon show up in grocery stores near you.

But why does the system have to change for us to eat this most modern of meat? And should we want it to?

Pigs, Cows, Chickens, and Drugs, Oh My

Today, a law called the Federal Food, Drug, and Cosmetic (FD&C) Act gives the FDA the jurisdiction to regulate all genetically modified livestock. The agency does so using the same certification procedures required of drugs — “Altered genomic DNA in an animal that is intended to affect the structure or function of the body of the resulting animal meets the definition of a drug,” FDA spokesperson Juli Putnam said in an email to Futurism.

The FDA’s rules encompass all editing processes, from transgenic editing (in which genes from one organism are introduced into another) to gene editing (which includes more precise editing techniques like CRISPR that simply “snip” portions of DNA to remove, relocate, or duplicate a useful trait).

Many geneticists argue that the gene editing done on animals today is so sophisticated that its outcome is no different from targeted breeding, which has allowed farmers to produce animals with specific traits for centuries. But some scientists note that the regulations around these animals haven’t changed since the early 1980s, when the process was less precise and poorly understood.

Functionally, these regulations mean that researchers developing genetically modified livestock must be rigorously tested to show that their animals, and the products that come from them (like milk or eggs), are safe for humans to consume. Because animals are living organisms, they don’t affect the body as predictably as a chemical might, animal geneticists say. Plus, most research facilities don’t have the funds to prove they’re safe in spite of that variation.

Little wonder, then, that only one animal, the AquaBounty salmon, has ever made it through the FDA’s system. And that isn’t even available in the U.S. because congress can’t agree how to label it.

The USDA, on the other hand, already handles the regulation around GE plants. It does so with nuance, separating the requirement for transgenic plants and gene edited plants. And its rules do little to inhibit the sale and use of gene-edited crops.

Biotech companies are hoping that if the responsibility for gene-edited animals is shifted to the USDA, the agency might look at gene-edited livestock with a similarly liberal lens.

If they do, Tech Review reports that activist groups that oppose the sale of GMOs, such as the Center for Food Safety, are already prepared to fight it.

The Future of Food

It’s probably unlikely that GE animals will ever be looked at the same way as GE plants. Though the leading science suggests GE foods are safe to eat, anyone bringing an animal to market should still have to prove their gene change doesn’t produce any other unexpected effects in the final organism. After all, animals are much, much more complex than plants.

Regulators also have to think about biodiversity, especially for aquatic animals raised in or near the water. Special measures will need to be taken to ensure human-modified animals don’t escape and mate with native ones.

Cows are being genetically engineered not to grow horns, which are usually painfully removed to prevent injury to humans and other cows. Image credit: Hannah Walker Smith/Cornell Alliance for Science

Still, there are compelling arguments to be made for why we should genetically edit livestock to supply humans’ desire for meat. Genetic modifications can make it easier for animals to handle the intense heat of climate change, ensure fewer creatures die needlessly by giving them disease resistance, and reduce animal distress by eliminating body features that are often painfully removed on a farm (like cows’ horns or pigs’ tails). Gene editing, then, might not only make meat more sustainable — it would make it more ethical, too.

Since much of the world looks to the U.S. to take the first leap in new fields, doing so could start the proliferation of genetically modified animals to the places in the world that need it most.

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Genetically Modified Algae Could Be Key to Tomorrow’s Bio Solar Cells

Algae Fuel

Researchers at the University of Cambridge have developed a new fuel cell that is powered by algae, and that is five times more efficient than existing models that use microscopic plants and algae. This new design is not only more efficient, it is also more cost-effective and practical to use than previous attempts.

These algae-powered fuel cells, described in the journal Nature Energy, are a type of biophotovoltaic (BPV) device, also known as bio solar cells. BPVs harvest solar energy and convert it into electric current using the photosynthetic abilities of microorganisms like algae. This is both an environmentally-friendly and cost-effective alternative energy source.

The green algae Glaucocystis sp., similar to that used by researchers in developing these bio solar cells
The algae Glaucocystis sp. Image Credit: Wikipedia.

The Cambridge team’s version utilized genetically modified algae that works more efficiently than normal, minimizing the amount of electricity that is dissipated without use during photosynthesis.

Additionally, in prior versions of BPVs, charging (light harvesting and electron generation) and energy delivery (transfer to the electrical circuit) have been located within the same compartment. In systems where this is true, electrons generate current right where they’ve been secreted. In this new approach, the researchers developed a two-compartment system where the processes of charging and delivery are separated.

Green Energy

“Charging and power delivery often have conflicting requirements,” explained Kadi Liis Saar, of the University of Cambridge’s Department of Chemistry, in a press release. “For example, the charging unit needs to be exposed to sunlight to allow efficient charging, whereas the power delivery part does not require exposure to light but should be effective at converting the electrons to current with minimal losses.” 

Renewable Energy Sources Of The Future [Infographic]
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This design enhances performance and allows for storage, so that energy created during the day could be saved and used at night or on cloudy days. Cells that lack such storage capacity would not be as practical for widespread, commercial use.

At the present, these bio solar cells are not yet powerful enough for significant use; though their energy density of 0.5 Watts per square meter quintuples other algal cells, it’s still only a tenth of that found in conventional solar fuel cells.

As such, these algae-powered cells probably won’t be powering large grids anytime soon. Yet the authors emphasized that they could be well-suited for small applications in sunny but underdeveloped places like Africa, as well as contributing storage power to the driving movement to replace fossil fuels with renewable energy.

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Genetically Modified Beetles Grew a Fully Functional Third Eye

The concept of a “third eye” is usually associated with perception beyond the physical world, but in a new scientific case, it provides insight into evolutionary development.

Researchers have intentionally genetically modified a common beetle to develop a third functional eye, right in the middle of its forehead.

It builds on previous research in which they caused a beetle to grow a third eye accidentally. Both studies were led by Indiana University postdoctoral researcher Eduardo Zattara.

“Developmental biology is beautifully complex in part because there’s no single gene for an eye, a brain, a butterfly’s wing or a turtle’s shell,” explained researcher Armin Moczek of Indiana University.

“Instead, thousands of individual genes and dozens of developmental processes come together to enable the formation of each of these traits. We’ve also learned that evolving a novel physical trait is much like building a novel structure out of Lego bricks, by re-using and recombining ‘old’ genes and developmental processes within new contexts.”

This means that evolving new features may not be as complicated as scientists previously thought, requiring fewer genetic changes.

genetically modified scarab beetle thirs eye full inset
(Eduardo Zattara/Indiana University)

In the original research, the team switched off a gene that is involved in the development of the heads of dung beetles, which caused quite drastic changes to the structure of their heads.

The beetles lost their horns – and developed a compound eye in the middle of their heads. Moreover, it only worked in horned beetles, not other kinds.

“We were amazed that shutting down a gene could not only turn off development of horns and major regions of the head, but also turn on the development of very complex structures such as compound eyes in a new location,” Zattara said last year.

“The fact that this doesn’t happen in Tribolium is equally significant, as it suggests that orthodenticle genes have acquired a new function: to direct head and horn formation only in the highly modified head of horned beetles.”

The development of organs in an abnormal place – called ectopic organs – is a technique scientists use to try and understand how new physical traits evolve.

This has been done in fruit flies – in 1995, a team of scientists published a paper that described how they’d managed to grow ectopic eyes on the wings and legs of fruit flies.

The work of Zattara’s team, by comparison, was much simpler. They set out to intentionally grow a third eye in two types of scarab beetle, Onthophagini and Oniticellini, by wiping out just a single gene, the same head development gene from their earlier research.

genetically modified scarab beetle third eye control comparison
Control (left) and genetically modified scarab (right). (Zattara et al./PNAS)

The third eyes the beetles developed actually resulted from fused pairs of eyes. They also lost their horns, or grew much smaller horns, consistent with the earlier research.

The team then conducted multiple tests to confirm that the new eye had the same cell types, genes, nerve connections and behavioural responses as a normal eye.

“This study experimentally disrupts the function of a single, major gene. And, in response to this disruption, the remainder of head development reorganizes itself to produce a highly complex trait in a new place: a compound eye in the middle of the head,” Moczek said.

“Moreover, the darn thing actually works!”

The research could help understand how organs develop and become part of a body – which knowledge, in turn, could prove useful in the development of artificial lab-grown organs, for both research and medical purposes.

The team’s paper has been published in the journal PNAS.

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Genetically Modified Apple That Doesn’t Brown Hits US Stores This Month

Fresh Flesh

Later this month, Okanagan Specialty Fruits will begin selling its Arctic apples across the midwestern US. The fruit will be sold sliced, as it’s been genetically modified such that its flesh doesn’t brown as its exposed to air.

The genetically modified apple was made possible by research carried out at the Commonwealth Scientific and Industrial Research Organisation in Australia. Scientists figured out a way to prevent the browning process by deleting the gene that encodes the enzyme responsible. Okanagan suppresses this enzme in order to preserve the fruit’s flesh indefinitely.

The company produces its Arctic apple in three different varieties; Granny Smith, Golden Delicious, and Fuji. Okanagan will start supplying 400 stores in the US with bags of apple slices over the coming weeks.

An Apple a Day

Many examples of genetically modified food benefit the producer, rather than the customer, but the Arctic apple bucks that trend. There are hopes that if it’s successful, it might pave the way for other products.

Genetic modification can offer a whole host of ways to augment food, from improving the nutritional value of corn, to reducing the amount of fat in pork. However, it can be difficult for these products to be approved by authorities like the Food and Drug Administration, and even more difficult for them to catch on with consumers.

The Arctic apple has received some criticism because of the fact that its packaging doesn’t explicitly state that the fruit has been genetically modified. Instead, there’s a QR code which is linked to more detailed information.

Even despite the benefits of genetically modified foods, many consumers are still reticent to actually introduce these items into their diet. The practical advantages of an apple that doesn’t brown might just convince people to dip their toe in the water.

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Doctors Reconstructed 80 Percent of a Boy’s Skin With Genetically Modified Cells

Using Genetic Modification to Save Lives

There exist in the world a rare genetic disease that causes the skin to become very fragile, to the point that it will blister easily from minor actions such as scratching or rubbing. This disease is called junctional epidermolysis bullosa (JEB), and while it may affect less than a million people in the world, it’s still a widespread condition in need of treatment, and one that’s harmful enough to bring devastating changes to a person’s life.

As reported by Science Alert, a 7-year-old boy was admitted to a hospital burns unit in Germany in 2015 due to the fact he had lost nearly 80 percent of the skin on his body to JEB. After traditional remedies failed, the boy’s parents turned to reconstructing his skin one piece at a time. Enter Professor Michele De Luca, a stem cell researcher from the University of Modena and Reggio Emilia in Italy. Along with his team, he developed a technique to treat JEB, which involved attaching genetically modified skin grafts to the dermis — the inner layer of tissue that makes up the skin, with the epidermis being the outer layer.

We’ve seen genetic modification used in the past with varying results. In 2016, gene modding was used to make mosquitoes that would hopefully eliminate other mosquitoes that transmit diseases. Last November, genetically modified E. coli bacteria was created to treat metabolism disorders in infants. Much more recently, scientists used genetic modifications to subdue the bacteria Francisella tularensis, which has been used as a bioweapon to cause tularemia — a disease that comes with joint pain and muscle aches.

Creating Genetically Modified Skin

De Luca and his team took skin cells from the 20 percent of the boy’s body that had yet to be affected by JEB, and used it to grow protein cultures free of the disease. These cultures were then used to make epidermal grafts, which were then used to replace the lost skin. In the team’s research — published to the journal Nature— they revealed the boy was released from the hospital in February 2016. This November, 21 months after the third and final surgery, he was examined once again, revealing he had made a full recovery and now had healthier skin.

“His epidermis is currently stable and robust, and does not blister, itch, or require ointment or medications,” said the team. However, they went on to suggest their treatment may not be required for patients suffering from lesser forms of epidermolysis bullosa (EB). The 7-year-old boy was an extreme case.

Furthermore, it’s unclear how long the boy’s skin will remain healthy, meaning he’ll need to go through additional examinations as he gets older. Regardless, De Luca’s success may pave the way for others to look into similar treatments and ways to create modified skin. According to Debraat least 500,000 people live with EB. If even one of them can find relief using De Luca’s technique — or a less intense version — it’ll be worth the time and effort.

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In Japan, Chickens Have Been Genetically Engineered to Lay Eggs That Fight Cancer

Genetically Engineered Eggs are Better than Golden Eggs

People often warn about the amount of cholesterol you get from eating too many eggs. But what if there were health benefits to eggs as well — like drugs that fight cancer, hepatitis, and other diseases? Japanese researchers from the National Institute of Advanced Industrial Science and Technology (AIST) did just that when they successfully genetically engineered chickens to lay eggs that contain a special pharmaceutical agent.

How CRISPR Works: The Future of Genetic Engineering and Designer Humans
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According to a report by The Japan News, the researchers at AIST genetically modified precursor cells of chicken sperm to produce a type of protein that’s related to the immune system called interferon beta.

This protein has been found to be effective in treating malignant skin cancer and hepatitis. The modified cells were used to fertilize eggs that produced male chicks. A few rounds of cross-breeding the male chicks resulted in chickens that inherited the genes with interferon beta.

Cheaper Drugs

Reagent import and sales firm Cosmo Bio Co. in Tokyo, which developed the method together with the AIST researchers and the the National Agriculture and Food Research Organization in Ibaraki Prefecture, now has three hens that lay eggs every one or two day. The egg whites from those eggs contain interferon beta.

Why go through such a tedious process? The project’s goal was to potentially reduce the costs of making drugs. “This is a result that we hope leads to the development of cheap drugs,” Hironobu Hojo, professor at Osaka University, told The Japan News. “In the future, it will be necessary to closely examine the characteristics of the agents contained in the eggs and determine their safety as pharmaceutical products.”

This is just one example of how gene editing methods can reshape industries, especially healthcare. Others have worked on applying gene editing such as CRISPR directly into cancer cells or to a patient. Producing cheap drugs from chicken eggs is another possibility — and a rather creative one, at that.

Moving forward, the researchers plan to work on stabilizing the interferon beta contents of the eggs to produce some a dozen milligrams to 100 milligrams from a single egg.

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Transplants of Genetically Modified Pig Organs for Humans Could Happen Within Two Years

Xenotransplantation

This year, novel organ transplant procedures have been getting a fair amount of attention. While some may seem rather bizarre — like that human head transplant currently in the works — others could be the beginning of a new era in organ transplantation. Chinese researchers have been working on using genetically modified pig organs for human transplantation, and they expect it to be available in the next two years.

Because they closely resemble human organs in terms of size and metabolism, pig organs are considered to be the best animal organs for human transplants — a procedure known as xenotransplantation. Studies involving pig organ transplants have shown considerable benefits, most notably a baboon that received a pig’s heart was able to survive for three years.

In order to confirm these effects, researchers from more than 10 institutes in China have asked permission from the government to conduct human clinical trials use pig organs for transplants. These trials are part of a a national xenotransplantation project funded by the Chinese central government.

Piggy Organ Bank

China seems to be leading the way in this field, producing more genetically modified pigs than any other country. For pig organ transplants to work, modifying pigs by removing certain genes are necessary to prevent the human immune system from rejecting the donated organsThe South China Morning Post (SCMP) reports that cloning farms in China produce a total of 1,000 cloned pigs a year, according to one researcher.

That’s potentially a huge pig organ bank, assuming the government manages to approve clinical trials soon. For Zhao Zijian, director of the Metabolic Disease Research Centre at Nanjing Medical University in Jiangsu, the government seems to be taking too long.

An Exponential Timeline of Organ Transplants
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“We have patients dying from organ failure and their desperate relatives pleading for them to have the chance to live,” Zhao, who’s also a senior scientist at a xenotransplantation lab, told the SCMP. “But when we turn to the authorities in charge of approving the clinical trials, all we get is silence. We understand it must be very hard for the government to make a decision, but it’s time we got an answer.”

Pig organs could speed up the process of getting transplants. In China, for instance, over 300,000 patients require organ transplants, but only less than 10,000 organs are donated each year. Moving forward, initiative when it comes to coming up with the necessary regulations are needed. “Someone has to take the first step – whether it’s the US Food and Drug Administration or the China Food and Drug Administration,” Zhao said.

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Scientists Have Officially Created Healthy Offspring from Genetically Infertile Male Mice

Extra Chromosomes

Creating a new tool to manage human infertility, scientists have developed healthy offspring from altered male mice that were once genetically infertile. The X and Y chromosomes determine sex, with chromosomes (XY) signifying male, and two X chromosomes (XX) signifying female. However, about 1 in 500 boys are born with one extra chromosome. Whether it’s an X or a Y, the presence of a third chromosome can cause infertility by disrupting the formation of mature sperm.
Scientists at the Francis Crick Institute have now discovered a technique for removing extra sex chromosomes in developed stem cells and producing fertile offspring. If they can transfer their findings and this technique for application in humans, those with either Double Y syndrome (XYY) or Klinefelter syndrome (XXY) that now experience male chromosomal infertility might one day be able to have children via assisted reproduction.
Image Credit: Zappys Technology Solutions/Flickr
Image Credit: Zappys Technology Solutions/Flickr

“Our approach allowed us to create offspring from sterile XXY and XYY mice,” lead author and Francis Crick Institute scientist Takayuki Hirota said in a press release. “It would be interesting to see whether the same approach could one day be used as a fertility treatment for men with three sex chromosomes.”

A Promising Technique

To accomplish this research, the team removed small sections of ear tissue from mice with both XXY and XYY chromosomal anomalies and cultured it. They next collected fibroblasts, which are connective tissue cells, and turned them into stem cells. During the transformation, the researchers noted that some of the cells had dropped the extra sex chromosome. Following this, they used a method developed in the past to guide the stem cells with specific chemical signals into becoming potential sperm cells. Once these cells were injected into mouse testes, they developed into mature sperm. These mature sperm were found to be viable, and so the researchers harvested and used them in assisted reproduction cycles to create fertile, healthy offspring.
The team has also conducted one preliminary experiment using men with Klinefelter syndrome. In that experiment, the researchers followed the first part of the same process and discovered that stem cells produced from the fibroblasts of these men also shed the extraneous sex chromosome. However, this was an early stage experiment, and extensive research remains before the technique will ever be viable for use in humans.
“There is currently no way to make mature sperm outside of the body. In our mouse experiments we have to inject cells that have the potential to become sperm back into the testes to help them finish developing. But we found that this caused tumors in some of the mouse recipients,” senior author and Group Leader at the Francis Crick Institute James Turner explained in the press release. “So reducing the risk of tumor formation or discovering a way to produce mature sperm in a test tube will have to be developed before we can even consider this in humans.”

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You Can Now Buy Genetically Engineered Salmon in Canada

GM Salmon In Stores

After 25 years of pushback from environmentalists and various controversies, genetically modified (GM) salmon have at last made it to shelves on the Canadian marketplace. AquaBounty Technologies has sold approximately five tons of “AquAdvantage Salmon” in Canada since its approval there last year. Although the fish were cleared by the FDA in late 2015, conflicts about labeling the fillets have stalled sales in the U.S.

The Maynard, Massachusetts company is the force bringing the GM Atlantic salmon to market. The salmon boast two extra genes that allow them to grow faster: a chinook salmon growth hormone gene that speeds their growth, and a gene from the ocean pout that keeps the chinook growth hormone gene “on” permanently. The end result of these changes is that the engineered AquAdvantage Salmon grow two times faster than typical salmon while consuming 20 to 25 percent less food.

Image Credit: AquaBounty Technologies
Image Credit: AquaBounty Technologies

These AquAdvantage Salmon are the first GM animal in the world to go on sale. As such, the product has garnered serious opposition from environmental groups. Beyond the labeling issue, these opponents fear that the fish pose a contamination risk to natural populations should they escape from their breeding tanks. However, as the fish are rendered sterile, and the FDA and the National Oceanic and Atmospheric Administration have inspected the facility and judged its containment measures to be adequate.

Controversy Over GM Foods

The fiery opposition to GM foods is no surprise. Although a comprehensive analysis from 2016 penned by 20 scientists and based on more than 1,000 studies, testimony from 80 witnesses in public meetings and webinars, and 700 comments submitted by the public found that GM crops are safe to eat and do not harm the environment, many in the public remain unconvinced. Meanwhile, farmers in India are beginning to plant GM mustard crops, and scientists are working to prove the safety of wheat “supercrops.”

Next Gen GMOs
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Stranger examples of GM organisms (GMOs) have been making the news recently, such as the GM surrogate hens being tested in the hopes they’ll be able to save rare species of poultry from extinction, and the Impossible Foods meatless burger, which has only recently run into a snag at the FDA concerning not its GM status, but its potential to act as an allergen.

The real breakthrough for products like AquAdvantage Salmon might be time and short consumer memory. As the salmon continues to sell successfully in Canada, other species may join it on the market’s shelves.

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