Daily Archives: January 21, 2021

While genetic engineering is the term typically used by scientists, you will start seeing the bioengineered label on some of the GMO foods we eat in the United States.

Humans have used traditional ways to modify crops and animals to suit their needs and tastes for more than 10,000 years. Cross-breeding, selective breeding and mutation breeding are examples of traditional ways to make these changes. These breeding methods often involve mixing all the genes from two different sources. They are used to create common crops like modern corn varieties and seedless watermelon.

Modern technology now allows scientists to use genetic engineering to take just a specific beneficial gene, like insect resistance or drought tolerance, and transfer it into a plant. The reasons for genetic modification today are similar to what they were thousands of years ago: higher crop yields, less crop loss, longer storage life, better appearance, better nutrition, or some combination of these traits.

Since GMO foods were introduced in the 1990s, research has shown that they are just as safe as non-GMO foods. Since then, the U.S. Food and Drug Administration (FDA), U.S. Environmental Protection Agency (EPA), and U.S. Department of Agriculture (USDA) have worked together to ensure that crops produced through genetic engineering are safe for people, animals, and the environment.

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With bioengineered food labels showing up in stores, here's what you should know about GMOs - Genetic Literacy Project

A Memorandum of Understanding (MOU) has been finalized regarding regulation of certain animals developed using genetic engineering. USDA announced the MOU with the Food and Drug Administration that outlines responsibilities regarding genetically engineered animals that are intended for agricultural purposes such as human food, fiber and labor.

This MOU complements USDAs issuance of an Advanced Notice of Proposed Rulemaking (ANPR) on the Movement of Animals Modified or Developed by Genetic Engineering on December 28, 2020.

Todays Memorandum of Understanding clears a path to bring our regulatory framework into the 21st century, putting American producers on a level playing field with their competitors around the world. In the past, regulations stifled innovation, causing American businesses to play catch-up and cede market share, said U.S. Secretary of Agriculture Sonny Perdue in a release. America has the safest and most affordable food supply in the entire world thanks to the innovation of our farmers, ranchers and producers. Establishing a new, transparent, risk and science-based regulatory framework would ensure this continues to be the case.

The terms of the MOU support USDAs ANPR outlining a contemplated regulatory framework that would apply to certain animals (cattle, sheep, goats, swine, horses, mules, or other equines, catfish, and poultry) developed using genetic engineering intended for agricultural purposes, USDA explains. Under this framework, USDA would safeguard animal and human health by overseeing pre-market reviews through post-market food safety monitoring for certain farm animals modified or developed using genetic engineering that are intended for human food.

The National Pork Producers Council (NPPC) applauded the MOU signed between the USDA and the FDA, giving USDA primary regulatory jurisdiction over the development of gene-edited livestock.

NPPC has been calling for this decision for more than three years to ensure that U.S. agriculture maintains its competitive edge globally. We look forward to working with the Biden administration to implement a technology that has the potential to improve animal health, further reduce agricultures environmental footprint and improve production efficiency, NPPC said in a statement.

The MOU also allows for the transition of portions of FDAs pre-existing animal biotechnology regulatory oversight to USDA. USDA would continue to coordinate closely with FDA to fulfill oversight responsibilities and provide the appropriate regulatory environment, ensuring the safety of products derived from new technologies and fostering innovation at the same time, the release said.

FDA would continue its review of intentional genomic alterations intended for any purpose other than agricultural use, such as biopharma and non-heritable genomic alteration, and the regulation of dairy products, table and shell eggs, certain meat products and animal feed derived from animals developed using genetic engineering.

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FDA Stalls U.S. Gene-Edited Livestock Efforts

USDA Oversight of Gene-Edited Livestock: A Seismic Shift for Agriculture

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Livestock Producers on Level Playing Field Thanks to MOU Between USDA and FDA - Pork Magazine

Bhuyan said that his company has plans to win over both farmers and consumers, and that many industries have already signed on to use the technology.

The traction we have gained spans multiple countries and supply chains ranging from meat, dairy, cannabis, coffee, leafy greens, and a range of non-organic items, he said. Its unclear which companies Aanika is currently working with, as only a handful of partnershipsincluding a collaboration with the diamond company, De Beers Grouphave been disclosed publicly.

A normal food recall can affect a dozen farms, some of which were not actually responsible for the outbreak. Instead of recalling produce from all those growers, Aanikas spores could instead be used to pinpoint the outbreaks source, which would have the additional benefit of reducing the number of claims that an insurance company would have to pay out. This year, Aanika will work directly with agricultural insurers, offering them up to $10 million in guarantees, an incentive to protect insurers against loss in case claims submitted to them by farmers are not reduced as a result of using Aanikas spores. The move was made public in a blog post that the company posted to Medium in December, and it could offer enough of a financial incentive to get more large-scale traction with farmers.

As for consumer concerns, Bhuyan said that, even if spores did end up on your dinner plate, the average person poops out thousands of bacterial spores every daya claim supported by a recent studyso we dont think this will be a problem.

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Foodborne diseases kill thousands of Americans each year. Tracing food with genetically engineered spores could help. - The Counter

This will address an accelerating gene therapy market that is expected to grow globally by 16.6 percent from 2020-2027.

"The Gene Therapy Ready network demonstrates our commitment to empowering sites and supporting our industry partners as they pursue advanced genetic engineering to find cures for the world's most pressing health conditions," said Scott Uebele, President and Chief Research Services Officer at Advarra. "Our commitment to efficient study activation is unwavering, and this is another example of how Advarra bringslife sciences companies,CROs, research sites, investigators,andacademiatogether at the intersection of safety,compliance,technology, and collaboration."

All Gene Therapy Ready sites stand ready to help industry sponsors conduct clinical trials that advance cures, develop vaccines, and find treatments for rare disease. By placing clinical trials with a Gene Therapy Ready site, research sponsors can save significant time during study startup.

"This innovative network is truly the first of its kind. We constantly look for ways to support our sponsors in rapidly starting trials in a safe, compliant, and quality manner. With the Gene Therapy Ready network, we can improve study startup times by a month or more, potentially placing cures in the hands of patients faster," said James Riddle, Vice President of Research Services and Strategic Consulting at Advarra. "The Gene Therapy Ready site network charts a course to success by providing our sponsor clients with a clear choice for IBC review services."

About Advarra

Advarra advances the way clinical research is conducted: bringing life sciences companies, CROs, research sites, investigators, and academia together at the intersection of safety, technology, and collaboration. With trusted IRB and IBC review solutions, innovative technologies, experienced consultants, and deep-seated connections across the industry, Advarra provides integrated solutions that safeguard trial participants, empower clinical sites, ensure compliance, and optimize research performance. Advarra is advancing clinical trials to make them safer, smarter, and faster. For more information, visit advarra.com.

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Advarra Announces New Gene Therapy Ready Site Network - PRNewswire

Imagine it's 2045. You start hearing rumors from your well-heeled friends about a mysterious corporation based on an undisclosed island that's offering an unprecedented service: the ability to genetically design your baby.

The baby will have some of your genetics, and some genetics from a sperm or egg donor, selected by you. But the rest of your child's genetic profile will be engineered by science. These changes will make it impossible for your child to develop genetic diseases. They'll also allow you to customize your child for dozens of traits, including intelligence level, emotional disposition, sexual orientation, height, skin tone, hair color, and eye color, to name a few.

This raises unsettling philosophical questions for some customers. "When does my child stop being my child?" they ask the corporate representatives. These wary customers are reminded of how risky it is to reproduce the old-fashioned way. The Better Genetics Corporation's motto sums it up: "Only God plays dicehumans don't have to."

This is the world described in a new science-fiction series by Eugene Clark titled "Genetic Pressure", which explores the moral and scientific implications of a future in which designer babies are becoming a major industry. The first book begins with the story of Rachel, a renowned horse breeder who befriends a billionaire client, and soon gets the funding to visit the tropical island on which the Better Genetics Corporation is headquartered.

There, corporate executives walk her through the process of designing a babyan experience that feels like an uncanny mix between visiting a doctor and designing a luxury car. The series is told from multiple perspectives, serving as a deep dive into a complex moral web that today's scientists may already be weaving.

Case in point: In 2018, Chinese scientist He Jiankui announced that he had helped create the world's first genetically engineered babies. Using the gene-editing tool CRISPR on embryos, He Jiankui modified a gene called CCR5, which enables HIV to enter and infect immune system cells. His goal was to engineer children that were immune to the virus.

It's unclear whether he succeeded. But what's certain is that the experiment shocked the international scientific community, which generally agreed that it's unethical to conduct gene-editing procedures on humans, given that scientists don't yet fully understand the consequences.

"This experiment is monstrous," Julian Savulescu, a professor of practical ethics at the University of Oxford, told The Guardian. "The embryos were healthy. No known diseases. Gene editing itself is experimental and is still associated with off-target mutations, capable of causing genetic problems early and later in life, including the development of cancer."

Importantly, He Jiankui wasn't treating a disease, but rather genetically engineering babies to prevent the future contraction of a virus. These kinds of changes are heritable, meaning the experiment could have major downstream effects on future generations. So, too, would a designer-baby industry, even if scientists can do it safely.

With major implications on inequality, discrimination, sexuality, and our conceptions of life, the introduction of designer babies would create a labyrinth of philosophical dilemmas that society is only beginning to explore.

One question the "Genetic Pressure" series explores: What would tribalism and discrimination look like in a world with designer babies? As designer babies grow up, they could be noticeably different from other people, potentially being smarter, more attractive and healthier. This could breed resentment between the groupsas it does in the series.

"[Designer babies] slowly find that 'everyone else,' and even their own parents, becomes less and less tolerable," author Eugene Clark told Big Think. "Meanwhile, everyone else slowly feels threatened by the designer babies."

For example, one character in the series who was born a designer baby faces discrimination and harassment from "normal people"they call her "soulless" and say she was "made in a factory," a "consumer product."

Would such divisions emerge in the real world? The answer may depend on who's able to afford designer baby services. If it's only the ultra-wealthy, then it's easy to imagine how being a designer baby could be seen by society as a kind of hyper-privilege, which designer babies would have to reckon with.

Even if people from all socioeconomic backgrounds can someday afford designer babies, people born designer babies may struggle with tough existential questions: Can they ever take full credit for things they achieve, or were they born with an unfair advantage? To what extent should they spend their lives helping the less fortunate?

Sexuality presents another set of thorny questions. If a designer baby industry someday allows people to optimize humans for attractiveness, designer babies could grow up to find themselves surrounded by ultra-attractive people. That may not sound like a big problem.

But consider that, if designer babies someday become the standard way to have children, there'd necessarily be a years-long gap in which only some people are having designer babies. Meanwhile, the rest of society would be having children the old-fashioned way. So, in terms of attractiveness, society could see increasingly apparent disparities in physical appearances between the two groups. "Normal people" could begin to seem increasingly ugly.

But ultra-attractive people who were born designer babies could face problems, too. One could be the loss of body image.

When designer babies grow up in the "Genetic Pressure" series, men look like all the other men, and women look like all the other women. This homogeneity of physical appearance occurs because parents of designer babies start following trends, all choosing similar traits for their children: tall, athletic build, olive skin, etc.

Sure, facial traits remain relatively unique, but everyone's more or less equally attractive. And this causes strange changes to sexual preferences.

"In a society of sexual equals, they start looking for other differentiators," he said, noting that violet-colored eyes become a rare trait that genetically engineered humans find especially attractive in the series.

But what about sexual relationships between genetically engineered humans and "normal" people? In the "Genetic Pressure" series, many "normal" people want to have kids with (or at least have sex with) genetically engineered humans. But a minority of engineered humans oppose breeding with "normal" people, and this leads to an ideology that considers engineered humans to be racially supreme.

On a policy level, there are many open questions about how governments might legislate a world with designer babies. But it's not totally new territory, considering the West's dark history of eugenics experiments.

In the 20th century, the U.S. conducted multiple eugenics programs, including immigration restrictions based on genetic inferiority and forced sterilizations. In 1927, for example, the Supreme Court ruled that forcibly sterilizing the mentally handicapped didn't violate the Constitution. Supreme Court Justice Oliver Wendall Holmes wrote, " three generations of imbeciles are enough."

After the Holocaust, eugenics programs became increasingly taboo and regulated in the U.S. (though some states continued forced sterilizations into the 1970s). In recent years, some policymakers and scientists have expressed concerns about how gene-editing technologies could reanimate the eugenics nightmares of the 20th century.

Currently, the U.S. doesn't explicitly ban human germline genetic editing on the federal level, but a combination of laws effectively render it illegal to implant a genetically modified embryo. Part of the reason is that scientists still aren't sure of the unintended consequences of new gene-editing technologies.

But there are also concerns that these technologies could usher in a new era of eugenics. After all, the function of a designer baby industry, like the one in the "Genetic Pressure" series, wouldn't necessarily be limited to eliminating genetic diseases; it could also work to increase the occurrence of "desirable" traits.

If the industry did that, it'd effectively signal that the opposites of those traits are undesirable. As the International Bioethics Committee wrote, this would "jeopardize the inherent and therefore equal dignity of all human beings and renew eugenics, disguised as the fulfillment of the wish for a better, improved life."

"Genetic Pressure Volume I: Baby Steps" by Eugene Clark is available now.

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Designer baby book trilogy explores the moral dilemmas humans may soon create - Big Think

21 January 2021by testbiotech-- last modified 21 January 2021

Testbiotech has published a new report providing evidence that the European Food Safety Authority (EFSA) is intentionally keeping significant risks related to genetically engineered (GE) plants 'in the dark'.

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While EFSA is aware that the data compiled by industry are insufficient to demonstrate the safety of the plants, it has nevertheless failed to take action to solve the problems. On the contrary, the authority has for years defended assumptions even if they are in contradiction to the facts. In addition, EFSA is intentionally trying to distract awareness away from the 'dark' sides of its risk assessment.

During the first 20 years of its existence, EFSA published more than 100 opinions on the risk assessment of GE crops, but was nevertheless unable to present sufficiently robust criteria and methods. The report published today reveals major gaps in risk assessment which can no longer be disputed. Moreover, the report also shows that specific areas of risk assessment are intentionally ignored .

"We need science more than ever to stop dangers such as climate change and pandemics. Science also has to be impartial, transparent and reliable when it comes to assessment of risky technologies and their profitable products. However, in the case of genetically engineered plants, the trade interests of industry are given priority when it comes to decision-making in the face of uncertainties," Christoph Then states for Testbiotech, an institute which is independent of the interests of biotech industry. Testbiotech has for more than ten years analysed the risks of genetically engineered organisms with a view to protecting health and the environment.

Testbiotech is accusing EFSA of a systematic failure to request sufficiently reliable data from industry. These problems concern, for example, field trials with genetically engineered herbicide-resistant plants that are sprayed with much lower rates of herbicide applications compared to current agricultural practice. Furthermore, the regions in which the field trials are carried out do not represent the bioclimatic conditions under which the GE plants are to be cultivated.

For the assessment of insecticidal Bt toxins produced in the plants, EFSA accepts experiments with toxins produced by bacteria. However, it is known that the toxins produced in the plants must be assumed to be much more toxic since plant constituents can multiply their toxicity. Furthermore, most of the approved GE plants carry a combination of (several) Bt toxins and (several) herbicide resistances. Nevertheless, EFSA does not request any empirical data on mixed toxicity or immunogenicity of the compounds present in the harvest.

At the same time, in regard to the potential spread of GE plants, EFSA makes assumptions that are outdated and therefore underestimates the actual risks. From a legal point of view, it also seems to be questionable that EFSA, in a self-assigned task, adopted a new guidance in 2015 allowing it to evade legally binding EU Commission standards in field trial assessments.

In conclusion, evidence has been provided to show that the genetic engineering of food plants has layers of complexity that go far beyond what can be assessed by current standards of risk assessment. The safety of the plants is claimed on basis of approval processes that only consider risks that are easiest to assess.

The Testbiotech analysis of the work of EFSA is also based on the outcomes of the RAGES (Risk Assessment of genetically engineered organisms in the EU and Switzerland) project. The RAGES project started in 2016 and ended in 2020; the outcomes were subsequently assessed by EFSA in June 2020.

Testbiotech is now urging the EU Commission to take action because the political responsibility for setting the standards in the risk assessment of GE organisms lies with the Commission.

What are the consequences of genetic engineering for humans and the environment? From a critical point of view, Testbiotech provides information and scientific expertise on the risks associated with these technologies, that is completely independent of the biotech industry.

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Risk assessment of GE plants in the EU: Taking a look at the 'dark side of the moon' EUbusiness.com | EU news, business and politics - EUbusiness

Cancer is a notoriously complex disease, in part because it may be caused by mutations among hundreds or even thousands of genes. In addition, most cancers exhibit an extraordinary amount of variation among genetic mutations, even between patients with the same types of cancers.

Consequently, cancer researchers have chosen to study interactions among groups of genes in certain biological pathways that are disrupted.

When genes in certain pathways are frequently mutated or disrupted, that pathway may play a critical role in the initiation or development of cancer. But unraveling the molecular mechanisms underlying those disruptions is extremely complex.

Now, UB researchers have developed a new, statistically more powerful method called FDRnet that can more effectively detect key functional pathways in cancer using genomics data generated by next-generation sequencing technology.

Published in Nature Computational Science on Jan. 14, the new method has the potential to give biologists more precise data with which to zero in on therapeutic targets.

Using the new method, we can find biological pathways in which genes are significantly mutated or disrupted, explains Yijun Sun, associate professor of bioinformatics in the Department of Microbiology and Immunology, Jacobs School of Medicine and Biomedical Sciences at UB and the corresponding author. It addresses some key challenges in molecular pathway analysis in cancer studies. Once the tumor biologists obtain this information, they can use it to verify our findings, and from there develop new cancer treatments.

By overcoming the limitations of existing approaches, FDRnet can facilitate the detection of key functional pathways in cancer and other genetic diseases, he says.

When Sun and his co-authors tested FDRnet on simulation data and on breast cancer and B-cell lymphoma data, they found that FDRnet was able to detect which subnetworks or pathways are significantly perturbed in these cancers, potentially leading tumor biologists to identify new therapeutic targets.

Co-authors with Sun are Le Yang and Runpu Chen, both doctoral students in the Department of Computer Science and Engineering, School of Engineering and Applied Sciences, and Steven Goodison of the Department of Health Sciences Research at the Mayo Clinic.

The research was funded by the National Institutes of Health.

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New computational method detects disrupted pathways in cancer - UB Now: News and views for UB faculty and staff - University at Buffalo Reporter