Category Archives: Transhuman News

(Beyond Pesticides. January 7, 2021)Unbeknownst to most Americans when they woke up on New Years Day 2022, a new labeling system for genetically modified-engineered foods promulgated in 2019 which does not mention genetically engineered or GMO ingredients, went into effect. Consumer, food, and environmental advocates say that the new label is misleading, insufficiently transparent, discriminatory, rife with loopholes, and confusing for consumers. The new labeling requirement mandates that genetically engineered foods bear labels that indicate that they have been bioengineered or that provide a text-messaging phone number or a QR code as avenues for further information. (Additional options such as a phone number or web address are available to small food manufacturers or for small and very small packages.) The new labeling rule from the U.S. Department of Agriculture (USDA) aims, according to the agency, to eliminate the crazy quilt of labels affixed to foods and ingredients that have been scientifically altered. According to an agency spokesperson, the rule is designed to balance the need to provide information to consumers with the interest in minimizing costs to companies.

Genetically altered food items and ingredients have heretofore been called, and labeled as, genetically engineered (GE) or genetically modified (GM), or as containing genetically modified organisms (GMO). The Washington Post reports that, The new rule requires food manufacturers, importers and retailers to disclose information whether foods are bioengineered or use bioengineered ingredients, doing away with well-established terms like genetically engineered and GMO on labels. However, other kinds of official certifications like USDA Organic and NON-GMO Project Verified will be allowed.

The new labeling arises out of several developments in recent years. The first was the so-called Safe and Accurate Food Labeling Act of 2015, dubbed the DARK Act the Denying Americans the Right to Know Act by its many opponents. This legislation reacted to efforts in Vermont, Connecticut, and Maine to enact state laws that would mandate labeling of foods and ingredients that were genetically engineered, or contained such ingredients. The food industry was not happy with such developments, and spent huge sums to thwart state efforts. Some food companies even stopped selling to Vermont grocers in order to avoid the extra costs of labeling and segregating such products. The passage of the DARK Act pre-empted Vermonts successful GE labeling law, which required such items to be labeled as produced with genetic engineering.

Other contributing developments were: (1) the 2016 Congressional passage of the National Bioengineered Food Disclosure Act, which directed USDA to establish a national mandatory standard for disclosing foods that are or may be bioengineered, and (2) the Trump USDAs subsequent 2018 announcement of the National Bioengineered Food Disclosure Standard (NBFDS), which resulted in the 2019 announcement of the new labeling rule that became mandatory on January 1, 2022. That standard defined bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in nature.

The Harvard Political Review sums up the status of GE/GMO foods in the U.S. marketplace, and the history of the battles over labeling of such food. Genetically modified crops, whichprimarilyinclude corn, soybeans, canola, and sugar beets, have been grown in the United States for 20years, and they have FDA [U.S. Food and Drug Administration]approval. Today, as much as75 percentof the food Americans buy at their local grocery store, from cereals to soups, include genetically modified ingredients. However, mostconsumersare not aware that the foods they are eating include these ingredients.

GE/GMO proponents argue that such foodstuffs are safe for human consumption. Opponents have a variety of objections (health and safety, pesticide contamination, ecosystem impacts, etc.) that are largely shared by Beyond Pesticides, but the central issue has been consumers basic right to know what they are purchasing and ingesting. Out of concern for all of those issues arose the Just Label It campaign, on which Beyond Pesticides partnered, and about which it wrote, nearly a decade ago, Beyond Pesticides goal is to push for labeling as a means of identifying products containing GE ingredients and allow for consumer choice that will drive the market toward sustainable practices.

This shift to the term bioengineered for labeling has been roundly criticized by advocates. Director of the project on biotechnology for the Center for Science in the Public Interest, Gregory Jaffe, has commented, The worst part of this law is the use of the term bioengineered because thats not a term most consumers are familiar with, adding that the move to the new jargon was made primarily because GMO had come to be perceived as pejorative.

In the summer of 2020, the Center for Food Safety (CFS) filed suit against the Trump administrations National Bioengineered Food Disclosure Standard and proposed labeling rule. CFS seeks to have the court declare the regulations unlawful and nullify them, and then return the issue to USDA with orders to fix the unlawful portions of the rules. The organization claimed that the new regulation includes provisions that will leave the majority of GMO-derived foods unlabeled; discriminate against tens of millions of Americans; prohibit the use of the widely known terms GMO and GE; and prohibit retailers from providing more information to consumers.

Among the objections CFS cites in its case are: unprecedented allowance of electronic or digital disclosure on packaging, also known as QR code or smartphone labeling without requiring additional on-package labeling

In its litigation, CFS argues that the new rule violates the National Bioengineered Food Disclosure Act, the Administrative Procedure Act (APA), and the U.S. Constitution. The first of those aimed to protect the publics right to know what is in their food and how it is produced; USDA was tasked by that law with creating and implementing rules to achieve those aims. Plaintiffs case documents state: USDAs final rule ignores virtually all the Disclosure Acts statutory provisions designed to ensure disclosure of all GE foods for all Americans. Instead, USDAs Disclosure Standard strips away the hard-fought labeling requirements of States requirements Congress sought to encompass replacing them with inaccessible digital disclosures, unfamiliar terminology, and an extra-statutory definition of bioengineered food. USDAs flawed rationales for doing so violate the plain language of the Disclosure Act and are arbitrary and capricious under the APA.

The suit also claims that the Disclosure Standard violates regulated entities First Amendment rights to provide disclosure to consumers, violates states Tenth Amendment rights by overbroadly prohibiting state laws related to GE seed labeling, and violates the Fifth Amendment by using vague and contradictory language, allowing for arbitrary enforcement.CFS adds, in its case documents: Left standing, the Disclosure Standard will result not only in de facto concealment of GE disclosures, but also a dangerous precedent for truthful and non-misleading commercial speech and for Congresss power to commandeer state governments. Accordingly, this Court should set aside the arbitrary and unconstitutional Disclosure Standard and sever and declare invalid constitutionally infirm provisions of the Disclosure Act. CFS filed a motion for summary judgment in the case in early December, 2021. (Such a motion asks a court for a judgment on the merits of a case prior to the actual trial; this is typically done when the dispute is about a question of law, rather than the facts of a case.)

The net impact of the new labeling schema, according to advocates, is that it puts a far greater burden on consumers to figure out what the labels mean, to do their homework so they are adequately informed (especially because there is, to date, no broad public campaign to apprise them of the change), and if industry takes the least transparent path of using QR codes and text messaging rather than labels to have to resort to in-the-moment research in the grocery store via smart phones they may or may not have and in settings that may or may not have cell or wifi service.

An issue for many advocates is the huge number of food items that would not be covered by the new labeling requirements. The NBFDS exempts (1) foods served in a restaurant, (2) very small food manufacturers with annual receipts of less than $2.5 million, (3) food certified under the USDA National Organic Program, and (4) food in which no ingredient intentionally contains a bioengineered substance, with an allowance for inadvertent or technically unavoidable presence of up to 5% for each ingredient.

CFS elaborates on this loophole issue and notes an additional concern: The vast majority of GE foods (by some estimates over 70%) are not whole foods, but highly processed foods with GE ingredients, like sodas and oils. Yet in the final rule USDA excluded these highly refined products, unless the GE material is detectable. Lastly, the statute invalidates state GE seed labeling laws and prohibits future GE seed labeling laws in violation of states rights to regulate in the absence of federal regulation. Even Forbes magazine has weighed in, writing that, One failing of the bill is that eventhe Food and Drug Administration (FDA) saysthat the definition of bioengineering in the bill is too narrow and would not apply to many foods that come from genetically engineered sources.

CFS Executive Director Andrew Kimbrell wrote, in a late December 2021 update on the organizations litigation, These regulations are not about informing the public but rather designed to allow corporations to hide their use of genetically engineered ingredients from their customers. It is a regulatory scam which we are seeking to rescind in federal court. In addition, we are urging our million CFS members and others to become citizen investigators and find and expose the companies that are using QR codes instead of on-package text or symbol labeling, thereby trying to keep us in the dark about what they have put in our food.

Beyond Pesticides Executive Director Jay Feldman had this to say: This label is recognition by USDA and Big Food that full and honest disclosure of GMO/GE ingredients will hurt the market. In the end, lying to consumers will not work, but it may hurt the value and credibility of other USDA labels, such as the USDA Certified Organic label that we have worked so hard to create in order to convey meaningfully important information about organic criteria, standards, and enforcement.

Few stakeholders appear thrilled by this rule at this moment in time. Some food companies, according to their trade groups, are asserting that instituting this new rule mid-pandemic, and during a supply-chain crisis, puts a significant burden on a sector already struggling. The Consumer Brands Association has urged USDA to pause implementation temporarily; a spokesperson commented: We believe the government must take a do no harm position right now that allows companies to focus on delivering essential products to consumers.

Long a proponent of transparency about the food supply, a few years ago Beyond Pesticides published advocacy points on the flaws of the then-anticipated labeling schema, asking USDA to ensure that labels are honest, transparent, and informative by adopting the following policies: reject package labeling with unreliable QR codes and other discriminatory communication methods; such options discriminate against more than 100 million Americans especially many in rural communities, as well as low-income, people of color, and elderly populations that tend disproportionately to lack access to these technologies

In light of the new labeling, consumers would do well to do their homework ahead of time, or in the grocery store, in order to parse the meaning of the new labeling. (The Washington Posts coverage of the new rule includes a useful What to Know section to help consumers understand implications of the rule for foods they buy and consume.) Perhaps an easier approach, for those who want to avoid GE/GMO food items, is to buy organic as much as possible because USDA National Organic Standards disallow the use of GEs/GMOs.

Source: https://www.washingtonpost.com/business/2022/01/01/usda-bioengineered-food-rules/#CEJNGNFJVRDINNQWQ2TPUJITFAA

All unattributed positions and opinions in this piece are those of Beyond Pesticides.

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USDA Genetic Engineered Food Label Misleads Consumers, Took Effect January 1 - Beyond Pesticides

The concept of genetic modification is polarising. While some believe both traditional and new plant breeding techniques are unnatural and unsafe, others see potential in the latter enabling greater yields to feed growing populations.

Yarin Livneh, a PhD student at the Hebrew University in Israel under the supervision of Professor Alexander Vainstein, falls into the second camp: she backs new plant breeding techniques otherwise known as gene editing to help overcome global challenges.

I am a great enthusiast when it comes to the applications of plant genome modifications, she explained. I believe a lot of the challenges our world is facing today such as climate change, malnutrition, pollution, and disease risk could be tackled with the aid of genetically improved research.

Livnehs most recent research is leveraging gene editing technology CRISPR/Cas to do exactly this, we were told: to improve the nutritional quality of an agricultural crop.

Not only could the fruits of my labour be commercialised as a healthier vegetable think more nutritious hamburgers, for example but the knowledge and experience Ive accumulated in the process could serve me in the future to tackle even more important goals.

The vegetable in question is the humble lettuce. Lettuce plants naturally produce a range of nutrients, such as vitamin C, beta-carotene, and thiamine (vitamin B). However, the plant only produces a limited amount of each only the amount required for the lettuce itself.

In Livnehs research, she leveraged CRISPR/Cas technology to target areas in the native lettuce genes that regulate the production and accumulation of these specific nutrients.

By slightly altering the regulatory components, I can trick the lettuce plants into producing or accumulating more of them, for the benefit of the consumer, she told FoodNavigator.

The genetic changes are very subtle', the researcher continued, and are considered gene editing rather than genetic engineering whereby whole genes are usually cloned from other species into the target plant.

I am editing existing genes in a way that could spontaneously occur in nature or when using traditional breeding methods.

The European Food Safety Authority (EFSA) recommends adults consume around 80mg of vitamin C per day. To meet these demands, adults would have to consume about 16 cups of regular lettuce, explained Livneh.

The recommended daily allowance of vitamin C, however, can be achieved with just two cups of the researchers shredded nutritionally-enhanced lettuce.

The research project was not without its challenges. A common issue in gene editing plants lies in delivering CRISPR/Cas machinery into the plant efficiently.

In order to do that, I utilised a delivery method based on a viral vector that usually infects plants and delivers its genetic material into them, Livneh explained. This method is relatively unique and was originally developed in our lab where it is used for other plant species as well.

Another challenge faced by the researchers was how to quantify the nutrients of the improved lettuce.

Our lab is mostly a molecular biology lab and our expertise is the use of molecular biology tools; therefore I am collaborating with several other labs that focus on specific metabolite analysis, we were told.

In Europe, the cultivation of gene edited crops is largely prohibited. Regulation is similarly tight in Israel, due to the markets trade ties in Europe, yet consumers themselves are less concerned by the technology itself, the researcher explained.

In terms of research, we are at the forefront of genetic research and application. The GMO debate is largely disregarded by the public, but still regulation here is tight because a lot of the produce grown here is exported to Europe.

Further, as a majority of Israeli start-ups seek commercialisation in larger, global markets such as Member States in Europe they must keep international GMO regulations in mind. Therefore, sadly, there is little interest in changing the current status quo.

Livneh does, however, see commercial potential for her nutritionally-enhanced lettuce, as well as other nutritionally-enhanced vegetables.

I have already received several enquiries from local lettuce growers and sellers eager to grow and sell the product, she told this publication. They are not deterred by the fact that the lettuce is genetically modified, but are unfortunately mostly unfamiliar with regulation and dont know the process required for approval.

The researcher remains very optimistic for commercialisation potential in global markets. The UK, which withdrew from the European Union in early 2020, has recently approved field studies for genetically edited crops, for example. And recently, a CRISPR-edited, nutrient-enhanced tomato entered the Japanese food market.

This suggests it is not the US alone that is embracing gene-edited crops, stressed Livneh: I think this trend will continue.

Excerpt from:
Nutritionally charged lettuce developed with CRISPR/Cas gene editing tech - FoodNavigator.com

The major food staples are essential to human survival. Chocolate and coffee are not essential, but try to imagine a world without them. One of the numerous concerns with climate change is that many species will lose their habitats. Scientists are projecting that, in the coming decades, this could lead to the extinction of many crops, including cacao and coffee plants.

The cacao tree is native to the Amazon Basin in South America. Over 1,500 years ago, the Mayas and other cultures in South and Central America cultivated the plant, and todayover 90 percent of the worlds cocoa is grown on small family farms. The cacao plants range is a narrow strip of rainforest roughly 20 degrees north and south of the equator, where the temperature, rain, and humidity are relatively constant throughout the year.

Like tropical fruits native to Hawaii, the cocoa industry has been ravaged by fungal infections. In Costa Rica, it never recovered from a fungal outbreak in the 1980s. The most recent outbreak occurred in Jamaica in 2016. Attempts by scientists to breed and create new hybrid varieties have failed. Today, most varieties of the cocoa plant are derived from genetically engineered plants or clones selected in the 1940s, which means they are susceptible to the same fungal diseases from the past.

Today,two West AfricancountriesCte dIvoire and Ghanaproduce over half of the worlds chocolate. By 2050, rising temperatures could push the current growing regions more than 1,000 feet uphill into mountainous terrain, an area nowmostly preserved for wildlife, according to the National Oceanic and Atmospheric Administration. Europe and the United States currently have large markets for cacao, while the demand in India and China is steadily growing. The reduced humidity caused by rising temperatures will make cacao trees extremely vulnerable and threaten the chocolate industry.

In contrast, the coffee plant has a variety of species. Temperature and rainfall conditions are the main drivers of crop yield. Scientists are projecting longer and more extreme periods of rain and drought, and along with rising temperatures, this could reduce the area suitable for growing coffee byup to 50 percentby 2050. Anextensive study foundthat of the worlds 124 wild coffee species, 75 (roughly 60 percent) are at risk of extinction due to climate change.

If scientists can identify which genes of the cacao and coffee plants to modify to adapt to new environmental conditions, they can help them survive. Researchers at the University of California, Berkeley, and Mars, a manufacturer of food products, are collaborating to conserve the cacao plant. In 2008, Marslaunched the Cacao Genome Projectto identify traits for climate change adaptability and developing higher yield. The researchers are using the genome editing tool CRISPR to edit the DNA of the cacao plant so that it can survive in warmer temperatures and drier conditions, and grow in different climates.

Genome editing allows breeders to introduce new traits more precisely and rapidly, potentially saving years or even decades in bringing needed new varieties to farmers. The US Department of Agriculture (USDA)does not plan to regulategene-edited plants or crops if they have traits similar to plants developed through traditional breeding techniques. However, the Food and Drug Administration (FDA)has the final sayover the safety of food for human consumption.

Other alternatives to coffee-as-we-know-it includeartificial coffeeproduced in a lab, which would require government approval, and moving millions of coffee farmers to new habitats. These options might make genome editing more appealing to activists.

The conventional wisdom is that farming is an organic practice and that tinkering with genes is risky and unethical. Advances in biological sciences have allowed scientists to provide a more balanced perspective on how farming practices and genetically modified organisms (GMOs) have impacted humans and our planet.

During the Agricultural Revolution, our ancestors transitioned from hunter-gathers to domesticating plants and animals. We now know that clearing the land increased global warming and standing water created breeding grounds for mosquitos which contributed to the spread of diseases such as malaria. Forests absorb greenhousegases and cattle emit methane during the food digestion process. Today, gases emitted by farm animalsaccount for 1418 percentof global greenhouse gas emissions. Domesticating farm animals has also led to numerous viral infections and poxes in humans which have produced epidemics.

In 1970, President Richard Nixon launched the War on Cancer to better understand the factors related to the development of tumors. Some scientists researched mutations caused by chemicals, the sun, and bombs, while others focused on viruses and bacteria that invade human cells. They discovered the molecular mechanisms used by viruses and bacteria which enabled the field of genetic engineering. They can use the same mechanisms to insert DNA with desired traits.

Genetic engineering has enabled scientists to develop life-saving drugs, produce food sources that can resist fungal and viral infections and live in harsh conditions, and prevent plant species from becoming extinct. In addition, it has stimulated the economy through job creation and hundreds of billions of dollars.

Traditional economics assumes that when humans make decisions they rationally weigh the costs and benefits and calculate the best choices for themselves. Behavioral economics, on the other hand,provides valuable insightsinto why some individuals do not behave in their own best interests. Some people make irrational choices based on errors and biases, while others utilize slow thinking, acquire new information, and are rational updaters.

Biotechnology companies have offered genetically engineered products in American markets since the 1980s. Given that both genetic engineering and recombinant DNA products have not caused any health and environmental problems during that time period, it is unclear why they are not more universally accepted.

In the absence of state and federal laws, scientists took it upon themselves to develop a plan on how to proceed safely with genetic engineering or recombinant DNA technology inside the lab. This led to the 1975 Asilomar Conference organized by the National Academy of Sciences held for four days in Pacific Grove, California. One hundred and forty biologists and physicians, four lawyers, and 12 journalists assembled to discuss the potential risks involved with recombinant DNA technology and to discuss and establish the conditions under which research should proceed.

While researching the mechanisms of cancer, scientists discovered that viruses can alter human cells in culture and transform cell lines into a cancerous state. At the time, they were concerned with the potential dangers of viruses if they spread in labs, while activists were worried they might harm the environment and infect humans outside the labs if they were misused. The scientists agreed to a voluntary moratorium on certain types of recombinant DNA experiments and containment on others until the risks were better understood.

Only months after the Asilomar Conference in 1975, as Chairman of the Subcommittee on Health, Senator Edward Kennedy chaired a hearing on genetic engineering and recombinant DNA. Kennedy was initially inclined to have an extended moratorium on research and allow more time for viewpoints from the concerned public and activists. The City Council of Cambridge, Massachusetts, did declare a moratorium on research, an act that was followed by similar bans in a number of other cities.

After further research, however, scientists learned that if they applied a knockouta technique used to make a harmful gene inoperativeit would make the virus harmless. In his 2001 book, A Passion for DNA, James Watson recalls that Kennedy then did an about-face and said, Following a period without the determination of any real risks; public hysteria cannot be maintained indefinitely in the absence of a credible villain of recombinant DNA technology. The Asilomar Conference has provided a successful framework for assessing the risks of emerging technologies.

In order to provide oversight in the lab, it is necessary to understand the technical aspects of genetic engineering, and to distinguish between real and perceived risks. Without the technical understanding there is a tendency to conflate oversight of the process and the product. Genetic engineering is a lab procedure used to recombine DNA (a process). Scientists can recombine DNA from two different species in order to produce an animal or plant with a desired trait (a product). Now that scientists have made the lab procedure safe, it is the responsibility of the appropriate federal government agenciesincluding the FDA, USDA, and Environmental Protection Agency (EPA)to test and approve the products.

Regulating the risks and safety of automobiles provides an interesting analogy which makes these concepts easier to understand than learning the technical aspects of molecular biology. In the United States, when the production of a Ford vehicle makes it to the Ford factory, the Occupational Safety and Health Administration (OSHA) provides oversight for the safety of the factory workers. As the car moves from a dealership to the highways, the Department of Transportation (DOT) and other government agencies mandate safety precautions such as seat belts, speed limits, laws on texting while driving, air bags, and so on to make driving safer and ultimately lower the fatality rate on American highways.

Human procreation is also a process that recombines DNA. Randomly and through natural selection, it recombines genes from the male and female genomes. In this case, the outcome is more unpredictable. But when DNA is recombined using genetic engineering, genes are selected for their functions.

Scientists later suggested that the National Institutes of Health (NIH) should form a Recombinant DNA Advisory Committee to establish safety guidelines, standards for conducting experiments, and oversight for NIH-funded projects. In 1976, a committee composed of experts in the field set safety guidelines matching the type of containment necessary for different types of experiments. Similar to the containment facilities for research on nuclear weapons during World War II, the levels of risk were categorized as minimal, low, moderate, and high, and required that scientists followed the appropriate safety standards and procedures at each level.

Given the uncertainty of outcomes with human procreation and the guidelines of the committee, one participant at the Asilomar Conference realized that they had just made human procreation amoderate risk experiment.

Historically, scientists have not fully understood the risks of most of the important technological innovations at the time of their invention.Today, the use of GM crops in the United States, South America, and Asia is a mainstream practice. The United States uses the proactionary principle, according to which risk assessment is based on science and self-regulation utilizing experts in the field.

The proactionary approach utilizes proportionality with an equal emphasis on risks and benefits. Restrictive measures are employed only if the potential impact of an activity is both significantly probable and severe, and the restrictions areproportionate to the extent of the risk. With the Asilomar model, manufacturers are held liable for the safety of their products, and regulators must demonstrate that they are not squandering resources and delaying social benefits to address minimal gains in safety.

Some European countries have utilized the precautionary principle for GMOs. With the precautionary approach, the burden of proof is on a manufacturer to prove the health and environmental impacts related to a new product is safe before it is approved. Using the precautionary approach, farmers have suffered financial losses and the benefits of products which can alleviate food shortages and nutritional deficiencies to citizens were delayed or denied.

In 1982,Genentechdeveloped the worlds first genetically engineered drug for patients suffering from Type I diabetessynthetic insulin. Prior to synthetic insulin, diabetes patients used insulin derived from human cadavers and animal insulin derived from pigs, sheep, and cows. Using the precautionary approach would have significantly delayed the medical benefits to many diabetics.

Societies do not accept the risks of technologies equally. Americas social contract with automobiles is very different than GMOs. According to the National Highway Traffic Safety Administration, over the last 20 years, Americans have accepted roughly40,000 annual traffic fatalitiesin return for a convenience that is engrained as part of our lifestyle. This figure fluctuates with regulations including speed limits and safety features in the automobiles, and technologies such as smart phones with texting which cause distractions.

To ensure citizens safely receive the social benefits of biotechnology, oversight would ideally take place through a rigorous clinical trials process similar to the pharmaceutical industry. However, the drug trials are time-consuming and cost-prohibitive for the development of most industrial products, and most biotechnology companies would likely not pursue development. Even with the time and costs dedicated to pharmaceutical clinical trials, a1998 study revealedthat roughly 106,000 people die each year in American hospitals as the result of the adverse health effects or side effects from prescribed medication.

In the past, failed regulatory oversight of the chemical industry left legacy issues and is a legitimate concern. With irrational fears, perhaps due to the inability to differentiate between science fiction and reality, activists are holding the biotechnology industry to a higher standard than other technologies.

Thousands of years ago, humans relied on wind and water wheels for power which were neither reliable nor scalable. Prior to the Second Industrial Revolution (18701914) human labor and farm animals were the major sources of power. Then electricity and internal combustion engines powered by fossil fuels lifted billions of people out of poverty and contributed to the growth of the middle class, reducing the number of hours they had to work and the amount of disposable income spent on subsistence.

In the 1950s, automobiles led to the rise of the suburban lifestyle in the US with gas-guzzling station wagons, modern kitchens, and numerous household appliances. Unfortunately, the Second Industrial Revolution is also remembered for contributing to climate change, and the start of the Anthropocene epoch is characterized by the influence of human activities on land-use changes, deforestation, and burning fossil fuels which accelerated species extinction and global warming.

Scholars have pointed out that, based on these human activities, the Anthropocene would have begun before the Second Industrial Revolution. Paul Crutzen argues that if it began with the production of carbon dioxide and methane at rates sufficient to alter the composition of the atmosphere this would coincide with James Watts design of the steam engine in 1784. William Ruddiman suggests that it began even earlier, and that the Agricultural Revolution that began around 8,000 years ago is a more accurate starting point.

Professional futurists look into the past to better understand probable scenarios for the future. Looking towards the future, societies should focus on making climate change manageable using this knowledge and learning how to best adapt to its inevitable effects. Much of the climate change debate is focused on causality. Deforestation, farming, cow flatulence, and using appliances and internal combustion engines are all contributors. Regardless of the politics of climate change, the effects are the same. Hopefully, planners, business executives, and public policy officials will have a game plan for adapting to the Anthropocene.

Given that climate change is occurring, regardless of the causenatural, man-made, or bothand that genome recombination and editing have enabled scientists to deliver a variety of foods and drugs safely, there is at least one option to prevent numerous species from becoming extinct. Thanks to advances in science and rational thinking, we gourmet chocolate and coffee lovers can continue to feed our addictions. This will confront GM opponents with a trilemmalabeled GM coffee, the artificial variety, or do without.

Randall Mayes is a technology analyst, author, futurist, and instructor of emerging technologies in Duke Universitys OLLI program.

A version of this article was originally posted at Quillette and is reposted here with permission. Quillette can be found on Twitter @Quillette

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What's the key, mostly missing, innovation that can help us adapt to severe climate change? Agricultural biotechnology - Genetic Literacy Project

- On track to initiate Phase 3 for treatment of phenylketonuria (PKU) in H2 2022 -

- Additional milestones include multiple clinical read-outs across programs including enteric hyperoxaluria and homocystinuria (HCU) during 2022 -

CAMBRIDGE, Mass., Jan. 06, 2022 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its proprietary approach to synthetic biology, today provided an update on progress towards multiple 2022 clinical milestones.

The past year was transformational for Synlogic as we achieved clinical proof of concept in phenylketonuria (PKU), a disease that causes tremendous burden to all of those affected. Current treatments leave a need for a safe, effective, and convenient oral treatment option and we are thrilled to be on track to begin the pivotal Phase 3 program in the second half of 2022, said Aoife Brennan, M.B. Ch.B., Synlogic President and Chief Executive Officer. Last year brought additional progress, including clinical proof of mechanism in enteric hyperoxaluria, a research collaboration with Roche and a new clinical candidate for homocystinuria (HCU) developed in partnership with Gingko Bioworks. Our plans for 2022 will build on this progress with multiple clinical data readouts expected across our programs.

Clinical Programs and Anticipated 2022 Milestones

In rare metabolic diseases, Synlogic reported positive interim data from the Phase 2 SynPheny-1 study in patients with PKU with its lead drug candidate, SYNB1618, in September 2021. PKU is an inherited inborn error of metabolism that results in significant disease burden, with current options leaving the majority of PKU patients either untreated or in need of better treatment options. In November, Synlogic announced SYNB1353, a drug candidate designed to consume methionine in the gastrointestinal tract developed through the Companys research collaboration with Gingko Bioworks, for the treatment of HCU, an inherited inborn error of metabolism that, like PKU, results in significant disease burden with limitations in todays treatment options.

In April 2021, Synlogic reported proof-of-mechanism with robust dose-dependent urinary oxalate lowering for SYNB8802, which is being developed for the treatment of enteric hyperoxaluria, a progressive, chronic disease characterized by recurrent kidney stones and risk of progressive kidney damage.

Synlogics research collaboration with Roche to develop a Synthetic Biotic drug candidate for the treatment of inflammatory bowel disease is continuing with the potential for additional research milestones during 2022. Synlogic and Ginkgo are also advancing their research collaboration to include additional, undisclosed preclinical assets.

Expected clinical milestones across these programs include:

Upcoming Industry and Banking Conferences

Synlogic will participate in the banking and industry conferences listed below in early 2022. Recorded presentations will be available at https://investor.synlogictx.com.

H.C. Wainwright BIOCONNECT Virtual Conference. Synlogic will present a corporate update at the H.C. Wainwright BIOCONNECT Virtual Conference taking place from January 10-13, 2022. The recorded presentation will be available beginning Monday, January 10, 2022, at 7:00 a.m. Eastern Time. BIO CEO & Investor Conference. Synlogic will attend and present at the 2022 BIO CEO & Investor Conference taking place virtually and in-person from February 14-17, 2022, in New York City. 11th Annual SVB Leerink Global Healthcare Conference. Synlogic will attend and present at the 11th Annual SVB Leerink Global Healthcare Conference taking place virtually from February 14-18, 2022.

About Synlogic

Synlogic is a clinical-stage biotechnology company developing medicines through its proprietary approach to synthetic biology. Synlogics pipeline includes its lead program in phenylketonuria (PKU), which has demonstrated proof of concept with plans to start a pivotal, Phase 3 study in the second half of 2022, and additional novel drug candidates designed to treat homocystinuria (HCU) and enteric hyperoxaluria. The rapid advancement of these potential biotherapeutics, called Synthetic Biotics, has been enabled by Synlogics proprietary, reproducible, target-specific drug design. Synlogic uses precision genetic engineering of well-characterized probiotics to exert localized activity for therapeutic benefit, with a focus on metabolic and immunologic diseases. Synlogic is also working with Roche in a research collaboration focused on the discovery of a novel Synthetic Biotic for the treatment of inflammatory bowel disease and with Ginkgo Bioworks to include additional undisclosed preclinical assets, combining Synlogics approach to Synthetic Biotics with Ginkgos Codebase and Foundry services. For additional information visit http://www.synlogictx.com.

About SYNB1618 and SYNB1934

SYNB1618 and SYNB1934 are orally administered, non-systemically absorbed drug candidates being studied as potential treatments for phenylketonuria (PKU), a genetic disease caused by potentially neurotoxic levels of the amino acid phenylalanine (Phe). Treatment options for PKU are currently limited due to efficacy and safety, with an estimated 80% of US patients remaining in need of treatment, and many of those who are treated in need of additional Phe-lowering. Synlogic designed drug candidates to reduce levels of Phe in people with PKU using precision genetic engineering of the well-characterized probiotic E. coli Nissle. Findings to date support the potential for an efficacious, safe, convenient, and flexible treatment option for PKU, and SYNB1618 has received both Orphan Drug and Fast Track designations by the US Food and Drug Administration (FDA). Both drug candidates are being studied in the Phase 2 Synpheny-1 study, with data expected in H1 2022, and initiation of the Phase 3 program to begin in H2 2022.

About SYNB1353

SYNB1353 is a novel orally administered, non-systemically absorbed drug candidate designed to consume methionine in the gastrointestinal tract thereby lowering homocysteine levels in patients with homocystinuria (HCU). HCU is an inherited disorder characterized by high levels of homocysteine and risks including thromboembolism, lens dislocation, skeletal abnormalities, developmental delay, and intellectual disability. Treatment options for HCU are currently limited due to efficacy and tolerability. SYNB1353 is currently in IND-enabling studies and was developed as part of a research collaboration with Synlogic and Gingko Bioworks. Synlogic holds worldwide development and commercialization rights to SYNB1353, which is expected to begin clinical development and report Phase 1 data in healthy volunteers in H2 2022.

About SYNB8802

SYNB8802 is a novel, orally administered, non-systemically absorbed drug candidate being developed for the treatment of enteric hyperoxaluria, a chronic, progressive disease characterized by high levels of urinary oxalate, the leading cause of recurrent kidney stones. Oxalate crystals can damage kidneys, leading to chronic kidney disease and end-stage renal disease (ESRD). SYNB8802 was designed using precision genetic engineering of the well-characterized probiotic E. coli Nissle to lower urinary oxalate levels by consuming oxalate throughout the GI tract. In 2021, Synlogic reported positive proof-of-mechanism for SYNB8802 from a Phase 1b study that demonstrated lowering of urinary and fecal oxalate levels in healthy volunteers with diet-induced hyperoxaluria. Data from a proof-of-concept study assessing the lowering of urinary oxalate in patients who have undergone Roux-en-Y gastric bypass surgery is expected in 2022.

Forward-Looking Statements

This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, clinical development plans, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. In addition, when or if used in this press release, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to Synlogic may identify forward-looking statements. Examples of forward-looking statements, include, but are not limited to, statements regarding the potential of Synlogic's approach to Synthetic Biotics to develop therapeutics to address a wide range of diseases including: inborn errors of metabolism,and inflammatory and immune disorders; our expectations about sufficiency of our existing cash balance; the future clinical development of Synthetic Biotics; the approach Synlogic is taking to discover and develop novel therapeutics using synthetic biology; and the expected timing of Synlogic's clinical trials of SYNB1618, SYNB1934, SYNB1353 and SYNB8802 and availability of clinical trial data. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including: the uncertainties inherent in the clinical and preclinical development process; the ability ofSynlogicto protect its intellectual property rights; and legislative, regulatory, political and economic developments, as well as those risks identified under the heading "Risk Factors" inSynlogic'sfilings with theSEC. The forward-looking statements contained in this press release reflectSynlogic'scurrent views with respect to future events.Synlogicanticipates that subsequent events and developments will cause its views to change. However, whileSynlogicmay elect to update these forward-looking statements in the future,Synlogicspecifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Synlogic's view as of any date subsequent to the date hereof.

SOURCE Synlogic, Inc.

Media Contact: Bill Berry, Berry & Company Public Relations, Phone: 212-253-8881, Email: bberry@berrypr.com

Investor Contact: Andrew Funderburk, Kendall Investor Relations, Phone:617-914-0008, Email: afunderburk@kendallir.com

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Synlogic Announces Progress Toward 2022 Clinical Milestones and Participation at Upcoming ... - KULR-TV

According to a study conducted by the University of Florida, eight days of intense meditation causes robust activation of the immune system.

The study has been published in the 'Proceedings of the National Academy of Sciences Journal'.

The findings are believed to be the first comprehensive genomic study of how meditation affects the biological processes directly involved in disease development. At the heart of the research is Inner Engineering practices, which are meditation and yoga programs that emphasize inner well-being.

ALSO READ: Here's how meditation can help in relieving stress

While the positive effects of meditation are well documented, far less is known about its molecular and genetic effects, said Vijayendran Chandran, PhD, an assistant professor of paediatrics and neuroscience in the UF College of Medicine.

Chandran's interest in the molecular roots of Inner Engineering actually started with some prodding by his wife -- and a dose of healthy scepticism. Just try it for 48 days, she said. He did so for about 21 minutes a day.

"I tried it and it worked really well. I just felt great," Chandran said.

That also awoke his scientific curiosity: How exactly did Inner Engineering practices benefit the body? To establish their findings, Chandran and his collaborators studied the genetic profiles of 388 samples obtained from 106 people before and after an April 2018 advanced Inner Engineering retreat at the Isha Institute of Inner-Sciences in McMinville, Tennessee. The retreat was tightly controlled: Participants remained silent for eight days, meditated for more than 10 hours a day, ate vegan meals, and followed a regular sleep schedule.

Blood samples from retreat participants were collected five to eight weeks in advance, then just before and after the retreat as well as three months later. The genomic analysis ultimately found several immune-related and other cellular pathways were altered after the meditation retreat.

Strikingly, they found increased post-retreat activity in 220 genes directly related to the immune response. That included heightened activity in 68 genes associated with interferon signalling, a key part of the body's anti-virus and anti-cancer responses. They also established that the enhanced immune system after the retreat is primarily due to meditation and not diet, sleep patterns, or gender differences.

Chandran, whose research specialties include bioinformatics and "big data" analysis, had more than 70 million data points from the blood samples. Like a police detective following a trail of evidence, Chandran let the data be his guide.

"What we found was that multiple genes related to the immune system were activated -- dramatically -- when you do Inner Engineering practices," Chandran said.

The increased gene activity among interferon-signalling genes is particularly significant, according to Chandran. Interferon proteins rally other parts of the immune system to defend against viruses and several recent studies have shown that interferon signalling is imbalanced in patients with severe COVID-19. Essentially, meditation used a coordinated network of core genes and regulators to unleash a positive effect on the immune system, the researchers found.

"This is the first time anyone has shown that meditation can boost your interferon signalling. It demonstrates a way to voluntarily influence the immune system without pharmaceuticals," he said.

The researchers reported that the findings also have potential implications for many immune-related conditions such as COVID-19 and multiple sclerosis. While meditation boosted activity in the 68 interferon-related genes, patients with severe COVID-19 have the opposite problem: a dearth of interferon activity that inhibits virus-fighting.

When researchers compared interferon gene activity in the retreat participants and severely ill COVID-19 patients, the differences were stark. Meditation activated 97 per cent of interferon-response genes, compared with 76 per cent gene activation in mild COVID-19 patients and 31 per cent in severe COVID-19 cases.

They also observed the opposite trend for inflammation-signalling genes, where they saw significantly high levels of inflammatory genes in severe COVID-19 patients, compared with mildly ill patients, and no change in inflammatory genes after meditation. Likewise, meditation produced beneficial gene activity comparable to conventional interferon treatments given to multiple sclerosis patients. Taken together, the findings supported the idea that meditation contributed to potentially improving multiple health conditions, the researchers concluded.

While the findings are intriguing, Chandran also said that the beneficial gene-activity effects need further study, including replication in a randomized clinical trial. It could also be helpful to determine if a less intense meditation regimen in the long term might produce similar beneficial immune-system effects, he said.

Research funding was provided by the UF Department of Pediatrics. Collaborators from the Indiana University School of Medicine, the University of Louisville, and the Beth Israel Deaconess Medical Center contributed to the research.

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Intense meditation may boost immunity: Study - Hindustan Times

An agile attorney-general should be anticipating online challenges. Van Badhams QAnon and On dives down the rabbit hole of conspiracy theories and finds more than a few mad hatters. An Ugly Truth: Inside Facebooks Battle for Domination, by US journalists Sheera Frenkel and Cecilia Kang, investigates the misbehaviour of the worlds largest social network eerily anticipating the recent revelations of whistle-blower Frances Haugen.

For an outlook on the Australian economy, John Edwards Reconstruction and Ross Garnauts Reset paint starkly different pictures. Edwards is sanguine about the strength of the economy in the 2010s, and optimistic about the future, provided we can repair relations with China. Garnaut is pessimistic, noting that from 2013 to 2019, Australias output per person grew more slowly than Japan. Edwards would have the Treasurer make some tweaks; Garnaut believes a transformation is required.

Far be it from me to tell the Minister for Women what to read, but in a year when thousands marched to protest against sexual harassment, I found a plethora of insights in new books by women who have served in the House of Representatives.

Julia Banks detailed the culture of the Liberal Party in her book.Credit:Simon Schluter

In Power Play, Julia Banks details the culture of the modern Liberal Party, drawing insights from her experiences in corporate Australia. In Enough Is Enough, Jenny Macklin and Kate Thwaites reflect on the Labor Party and how it has evolved. In Sex, Lies and Question Time, Kate Ellis interviews women from across the political spectrum and offers a suite of reforms that would improve the culture of Parliament.

As Curtin knew, a great education isnt just about imparting facts but building understanding and a deep love of learning. My English teacher, Judith Anderson, might not have approved but John McWhorters Nine Nasty Words brings the talent of a great linguist to the topic of profanity. Did you know that our taboo swear words have evolved from religion to bodily functions to identity groups? Its f---ing fascinating.

And what maths student couldnt be captivated by Jordan Ellenbergs Shape: The Hidden Geometry of Absolutely Everything? In our family, it led to a lively dinner table debate over one of Ellenbergs quirky questions: how many holes are there in a pair of pants one, two or three?

Finally, if the Education Minister wants a sophisticated analysis of academic freedom in universities, Carolyn Evans and Adrienne Stones Open Minds is it.

This year, the author who has most shaped how I think about the world is Cal Newport. Over the past two decades, Newport has evolved from writing advice books for students (How to Be a High School Superstar, How to Win at College) to writing advice books for professionals seeking to make an impact on the world (So Good They Cant Ignore You, Deep Work) to critiquing the way that social media and email are undermining our ability to truly connect with our friends and produce high-quality work.

His latest books, Digital Minimalism and A World Without Email, go beyond advice to critique the systems themselves. The next productivity revolution, Newport says, will come from companies that free their employees from multitasking madness and create space for people to do great uninterrupted work.

Im yet to fully implement Newports philosophy, but Im excited by its implications. Social media has its place, but a full life also involves bushwalks and picnics, craft projects and ocean swims. Living well also means books glorious books that enrich our souls, challenge our beliefs, and help us empathise with people in different times and places. What Curtin missed in formal education, he made up by immersing himself in books for the rest of his life. Leaders should be readers, and a life of books is a life well lived.

Andrew Leigh is a member of the Australian Parliament. His most recent book, Whats the Worst That Could Happen? Existential Risk and Extreme Politics, is published by MIT Press.

A weekly read for book lovers from Jason Steger. Sign up now.

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What books should our leaders be reading ... and why - Sydney Morning Herald