Category Archives: Genetic Engineering

As of January 1, 2022, food thats been previously known as a GMO or genetically engineered food will have a new Bioengineered (BE) label. If the term leaves you confused or searching your favorite online encyclopedia, youre not alone. Critics of the new legislation are concerned that the new GMO rebrand may cause even more confusion and less transparency than its predecessor.

The Center for Food Safety,a San Franciscobased nonprofit whose stated mission is to protect the earth from harmful impacts of industrial agriculture, has already filed a lawsuit asking a federal court to strike down this and other labeling laws instituted by the Trump administration.

Consumers have fought for decades for their right to know whats in their food and how its produced, stated Meredith Stevenson, an attorney for the center, in a press release. But instead of providing meaningful labeling, USDAs final rules will only create more uncertainty for consumers, retailers, and manufacturers.

Most consumers are familiar with the term that "bioengineered" replaced GMO, which stands for genetically modified organism. A GMO is a plant, animal, microorganism or other organism whose genetic makeup has been modified in a laboratory using genetic engineering or transgenic technology, which results in combinations of plant, animal, bacterial, and virus genes that dont occur in nature or through traditional crossbreeding methods, according to the Non-GMO Project, a nonprofit that aims to inform the public about what is in their food and how to access non-GMO choices (and whose verification seal has been one of the most prominent ways to identify non-GMO packaged foods).

The definition of a bioengineered food is quite similar. According to the United States Department of Agriculture (USDA), a bioengineered (BE) food is food that contains genetic material that has been modified through certain laboratory techniques and for which the modification could not be obtained through conventional breeding or found in nature. Despite this definition, some exemptions in the BE labeling mandate mean that many foods that contain GMOs by current standards may not have to be labeled that way under the new guidelines (see items 3 and 4 below).

Keep reading to learn what a BE label means for you and your health, and how to spot foods that arent bioengineered.

RELATED: What Is a Black Box Warning for a Drug?

These labels both the Non-GMO Project label and the new Bioengineered label are marketing tools, says Peter Goldsbrough, PhD, a professor of botany and plant pathology at Purdue University in West Lafayette, Indiana, who specializes in GMOs and GMO educational practices. If you read the USDA position on this, its clear the labels are for marketing purposes, to let consumers know what theyre buying, says Dr. Goldsbrough. Unfortunately, this new terminology may confuse people. Most consumers are already unclear about what GMO means, and this will probably add to that, he says.

Still, the new labeling doesnt change anything about the composition of the food we're purchasing and eating, Goldsbrough says. Humans have been genetically modifying crops using selection and breeding since agriculture began, over 11,000 years ago. The types of food ingredients that have been genetically engineered or bioengineered are going to remain the same, he says, and there will be new foods added as the technology continues to develop.

I think one of the most important things that people need to know is that there are no health safety concerns about consuming GMO foods, says Goldsbrough. Thats the position of the U.S. Food and Drug Administration [FDA], the World Health Organization, the European Food Safety Agency all these agencies have concluded that theres no safety concerns with the genetically modified foods that are on the market today. The presence or absence of a non-BE or Non-GMO label doesnt mean that a food is healthy or unhealthy, he adds.

RELATED: Why Are Some Food Additives That Are Banned in Europe Still Used in the U.S.?

Food items that contain ingredients that are considered highly refined such as sugar and corn oil dont require bioengineering disclosure, so they'll have no BE label. For example, when genetically modified corn is processed to make oil or corn syrup, the resulting highly refined ingredient shows no detectable DNA from the bioengineered crop, and therefore is not required to bear a bioengineered label. Excluding foods that use these ingredients makes the number of foods that will have a BE label considerably smaller, says Goldsbrough. An awful lot of things contain corn or soybean oil.

Food industry and food advocacy groups are divided on the omission of these products, according to the Center for Science in the Public Interest, but the USDA decided that an ingredient is not a bioengineered food if the genetically modified material is undetectable, says Goldsbrough.

Advocates for disclosure claim that there is evidence that the highly refined ingredients contain genetic material, even if its not detectable. Many products made with newer GMO technologies such as CRISPR, TALEN, and RNAi are currently untestable and therefore dont require a BE label, according to the Non-GMO Project.

Even though its not required, some companies may choose to disclose that they are using those highly refined ingredients that come from genetically modified crops, according to the USDA. These foods may state Derived From Bioengineering or Ingredients Derived From a Bioengineered Source on their label.

Products made with meat, poultry, or eggs are exempt from the BE labeling law. Multi-ingredient products in which meat, poultry, or eggs are the first ingredient are also exempt, even if other ingredients in the product do have detectable levels of modified genetic material.

The USDA gives the example of a can of pork stew that also contains genetically modified sweet corn. If pork is the main ingredient and listed first on the ingredient panel, the can of stew wouldnt be required to have a BE label because meat is exempt from the labeling requirement. If the stew lists water, broth, or stock as the first ingredient and pork as the second, that would also not require a BE label because water, stock, and broth dont count. The only way the stew would earn a BE label is if there was more corn than pork in the stew.

Because the new bioengineered definition leaves out foods that contain the highly refined oils and sugars that are derived from genetically modified food as well as multi-ingredient foods (such as the pork stew example), the position of the Non-GMO Project is that the Bioengineered Food labeling law is ineffective at finding GMOs and avoiding GMOs, largely because of restrictions, loopholes, and exemptions.

Foods that have detectable modified genetic material and are considered bioengineered will be identified on their packaging or label with one or more of the following:

The Non-GMO Project label, which depicts an orange butterfly on a green blade of grass, will continue to be used on a voluntary basis by companies that wish to adhere to the groups more stringent standards.

RELATED: 10 Common Food and Medication Interactions to Avoid

Products that sport a USDA Certified Organic label must be free of GMO and bioengineered ingredients. This was decided because the organic food industry does not want to use foods that are genetically modified, and its a way of distinguishing their brand from conventional foods, says Goldsbrough. So for consumers who want to avoid bioengineered foods, seeking out certified organic foods is probably the simplest and most reliable way to do that. Although there isnt evidence that GMO foods are harmful, its consumer choice, he says. If people wish to avoid genetically modified foods, this is one way to go about that.

In general, the foods that are most likely to contain GMOs or bioengineered ingredients are those that are the most processed. If you go into the sections where foods are more processed and use corn or soybean ingredients, unless theyre organic, they are more likely to contain items that are derived from a bioengineered crop plant, says Goldsbrough. If you tend to shop for fresh produce, meats, and dairy, on the other hand, those are less likely to be genetically modified. Ultimately, it's one more reason to keep your diet as minimally processed as possible.

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6 Things You Need to Know About the New GMO Food Label - Everyday Health

Dublin-based Horizon Therapeutics is expanding in Montgomery County, Md., on the heels of last years acquisition of Gaithersburg, Md.-based Viela Bio, another biotech company.

Horizon Therapeutics has signed a long-term, 192,000-square-foot lease at Alexandria Center Traville Gateway, a planned 500,000-square-foot life sciences complex being developed by Alexandria Real Estate Equities on 18 acres in Rockville, Md.

The global life sciences company will occupy an entire building, which is the first one under construction at the complex and is scheduled to be ready sometime in 2023.

The opportunity to custom build a state-of-the-art facility that suits our current and future [research and development] and technical operations needs was attractive, Geoffrey M. Curtis, an executive vice president in corporate affairs at Horizon Therapeutics, told CO.

The company has operated out of approximately 32,000 square feet in two buildings at 1 MedImmune Way in Gaithersburg since its Viela Bio acquisition in March and will be relocating when the space is available.

The new space will serve as our East Coast R&D and technical operations hub and will allow for all employees and functions to be in one building, Curtis said.

The new facility will also allow Horizon Therapeutics to quadruple its current Maryland footprint and better drive its continued efforts to develop new medicines for patients with rare, autoimmune and severe inflammatory diseases, he noted.

Maryland Gov. Larry Hogan released a statement praising the news and championed the life sciences sector in the state.

It is a testament to our outstanding business climate and wealth of resources that we have seen so many life sciences companies expand and add thousands of new jobs in our state in recent years, he said.

Maryland is considered a top 4 cluster nationally by Genetic Engineering & Biotechnology News annual ranking of the nations top 10 life sciences clusters, with Montgomery County responsible for a lot of the demand and growth.

Horizon Therapeutics was represented by CBRE in the transaction. The developers were represented in-house.

Requests for comment from the development team and CBRE were not immediately returned.

Keith Loria can be reached at Kloria@commercialobserver.com.

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Biotech Giant Horizon Therapeutics Expanding in Montgomery County - Commercial Observer

Indias transportation sector contributes about 10 per cent of total national greenhouse gas (GHG) emissions. Out of which, road transportation contributes about 87 per cent of the total emissions. Clearly, achieving net zero emission by 2070 implies road transportation needs significant overhaul. While EV or hydrogen fuel cell based transportation may be the mainstream in the long run, biofuel is expected to play an important role in the near future. With this in mind, Transport Minister Nitin Gadkari announced on November 11, 2021, that flex-fuel engines will be made mandatory in the coming days.

The advantage of flex-fuel engines is that it can run with 100 per cent biofuel, unlike a standard engine which develops problem if blending ratio goes above 20 per cent. The flex-fuel, or flexible fuel, is basically biofuel made with a combination of gasoline, methanol or ethanol where blending ratio may shift from zero to 100 per cent.

The aim is to gradually shift to fuels which are import substitutes, cost effective, indigenous and pollution-free. The entire automobile sector in Brazil runs on flex-fuel engines. The blending varies depending on the availability of biofuel feedstock and price of global crude oil. As a result, international crude oil price does not pinch them anymore.

While the idea of pushing towards flex-fuel auto-engine is a novel one, the stark reality is that we do not have the feedstock even for 20 per cent bending ratio. Currently, the supply is enough to meet about 8.5 per cent blending ratio. The government has decided to step up domestic manufacture of biofuels by 10 per cent every year and has advanced the target of blending 20 per cent ethanol in petrol to 2025, from 2030. But there is no way that the target can be achieved by 2025.

Moreover, increasingly, India is using its large inventory of foodgrains of low quality (due to improper storage) to produce biofuel. Earlier, they were used for fodder for animals. But the tendency is now to use them for producing ethanol. Surely, this is not a sound proposition as these foodgrains were procured at higher prices.

Biodiesel production involves four distinct stages (i) cultivation of oilseeds bearing plants from which seeds would be harvested; (ii) trading of seeds which involves procurement of seeds from the individual farmers and selling them to the processing factories; (iii) oil extraction from the seeds and transforming the extracted oil to biofuel through the process of trans-esterification; and (iv) blending this biofuel with the petrol/diesel and its disposal to individual consumers through retail outlet.

Originally, Indias biofuel programme identified a few oilseeds whose cultivation was encouraged to meet feedstock supply. However, this policy is now discarded in the new biofuel policy. Increasingly, the focus is now of adopting second generation biofuel process, namely producing biofuel from used vegetable oil, crop residue.

Most of the latest plants that are now being built are capable to use crop residue, used vegetable oil or oilseed to produce biofuel.

While the policy seems to be sound on paper, very little has been achieved. Only two bio-refineries with capacity of 500,000 litres/day of ethanol from spoilt and surplus foodgrain have been constructed by Indian Oil Corporation out of the 12 new bio-refineries to be built across 11 States in the country.

To have a long-term solution to stubble burning in northern India, notably Punjab, Haryana and Western UP, the idea is to construct a bio-refinery so that the same can use crop residue to produce ethanol. However, no plant has come up so far as it may not be economically viable given the current taxes/incentives schemes.

Gathering crop residue during harvest time is a costly proposition unless the farmers are given enough incentive to bring the crop residue to the proposed plant after harvest. Also, gathering a steady supply of other feedstock during non-harvest time is also an issue that entrepreneurs worry about. Somehow, the incentive scheme is not tilted in favour of production of biofuel.

Most countries which have been successful in promoting biofuel have banked on some crops as feedstock. Most also have undertaken genetic engineering on the crops so that the yield is maximised. Take the case of Brazil. Most of its ethanol is produced from sugarcane directly for efficient extraction.

On the other hand, India uses by-products (molasses) from sugar production to produce ethanol. This is not an efficient process with low yield. Of course, the sugar producers gets better price of their by-products.

It is best that India identifies feedstock, undertakes genetic engineering on the plants if it plans to use biofuel in a big way in the transportation sector. The use of used oil and crop residue for biofuel can at best supplement biofuel production, but can never fulfil the target what India needs if it wants to replicate Brazilian experiment with biofuel.

No doubt, support for feedstock producers as well as the biofuel production value chain for a sustained 3-5 years is needed if the sector has to take off. Will the government bite the bullet in the coming Budget?

The writer is Professor, NCAER. Views are personal

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How India can give a boost to biofuels - BusinessLine

Science and politics intersect on many levels. Many scientists depend on public funding to conduct their research an inherently political process and political leaders depend on scientists to inform their policy decisions. As well, the ethical ramifications of scientific research bear directly on ordinary citizens, who depend on governments to determine what lines of scientific inquiry are supported.

Politics and Expertise: How to Use Science in a Democratic Society, by Zeynep Pamuk (Princeton University Press, 256 pages).

But Zeynep Pamuk, a political scientist at the University of California, San Diego, feels the interplay between these two worlds science and politics has only begun to be properly explored. Pamuks interest in this relationship began early in her career, when she started to examine the discourse surrounding climate change. I realized that there was great scholarship on climate change, but it didnt get a lot of uptake, Pamuk told Undark. So I became interested in why that was the case. What is it about the intersection about science and politics thats become so pathological? She eventually saw that there wasnt as much scholarship on that question, especially from within political science.

In her new book, Politics and Expertise: How to Use Science in a Democratic Society, Pamuk outlines new directions that she believes the relationship between science and politics might take, rooted in the understanding that scientific knowledge is tentative and uncertain. Among her proposals is the resurrection of the idea of a science court, an idea first put forward in the 1960s.

The interview was conducted over Zoom and has been edited for length and clarity.

Undark: Much has been written on the importance of scientific literacy, and, especially in the last few years, on the problem of science denial and on the trust, or lack thereof, in science and scientists. But you frame your investigation very differently. What was your starting point?

Zeynep Pamuk: Theres a lot of discussion about denial of science, why citizens are so ignorant, why they dont understand science. And I wanted to change the conversation, by understanding how the way science is done, how scientific research is conducted, how the choices that scientists and science administrators make at far earlier stages of the research process shaped the uptake and framing of the debate. So I think the contours of the debate were too narrow.

UD: In your book, you talk about the idea of scientists taking responsibility for their research. Thats an idea with a long history one thinks of the atomic bomb, for example, and genetic engineering. How do you see this issue of responsibility for scientists?

ZP: Im interested in the question from the perspective of how a democratic society deals with the presence within it of this knowledge-producing but fairly autonomous community of scientists. So when I say that scientists need to take responsibility, I dont mean it in the way that a lot of people said about the atomic scientists that they could be held morally responsible.

Sure, I dont disagree with that. But I was more interested in what society could do to regulate these kinds of high-risk scientific endeavors. And I didnt think that the answer that scientists have to be morally responsible, to examine themselves and restrain themselves the idea that they self-monitor, that they can be trusted to do that was a sufficient answer.

UD: Are you saying that science requires more regulation or oversight?

ZP: In certain kinds of very high-risk scientific research, these decisions should be made collectively, or at least by authorized political representatives. They should have more public debate around them. The Obama administration at one point put a moratorium on lethal pathogen research. Theres some coverage, not a huge amount of discussion; and then it reversed its decision three years later. Its very difficult to find any paper trail about what happened. What was the discussion? What was the reasoning? Did they decide it was now safe?

Its very hard to know what happened. And it seems like this is hugely consequential on a global, planetary level. So there has to be more discussion around it. This kind just kind of risk decision should not be left purely to scientists. We can assign them responsibility but it doesnt mean that they should they alone should be responsible for making this very consequential decision.

UD: Should governments be able to tell scientists that certain lines of inquiry are off-limits?

ZP: I think the answer is yes. Im not going to say this area should be restricted or that area I think this is a collective decision. My opinions are my personal opinions as a citizen of a democratic society. But I think more debate is appropriate. And in certain cases, there might be a lot of support for undertaking risky research, because people imagine that it will bring a better world but in other cases, there are no conceivable benefits. Im thinking maybe of killer robots, as one example. Or maybe that the benefits dont justify the risks. So its something that would come out of debate. But I think there can certainly be areas where limits should be placed on research.

UD: One very interesting idea in your book is the notion of a science court. What exactly is a science court? How would it work, and what would its purpose be?

ZP: I stumbled upon this idea as I was looking at debates around science in the 1970s. This was a period where there was a lot of debate, because scientists were very influential; the glow of the World War II victory was around them. They had direct influence over politics. And but of course, they disagreed among themselves. And a scientist called Arthur Kantrowitz suggested a science court, basically to adjudicate between disagreeing scientists, so that the public confusion that this caused would just come to a stop.

But he had a strict division of facts and values: This would be the factual stage, and then the values would be discussed later. And for the reasons I just mentioned, I didnt think that that would make sense. You cant debate the science independently from the context of policy context or the context of use. And also, I thought this was a fairly elitist institution, with only scientists participating.

UD: But you feel there was something of value in Kantrowitzs idea?

ZP: I wanted to reimagine it. I took his structure, with different, disagreeing scientists making a case for their own views; but I wanted to have citizens there, and I want it to be a more overtly policy-oriented institution. So the way I imagine it, there would be a scientifically-informed policy debate like, for example, should we have strict lockdowns, or a less strict Covid-19 policy?

So it would have two clear sides and then scientists for both sides would defend their views. They would ask each other questions that would help reveal the uncertainty of their views, the evidence that theyre marshalling. And then the citizen jury would be randomly selected. They would bring their own political beliefs, they would listen to the scientists, and they would make a policy proposal, selecting one of the two positions.

UD: But scientists and politicians already argue a great deal. How would a science court be an improvement on the current system, in which theres already a lot of debate?

ZP: Its true that scientists constantly argue among themselves, but Im not sure the scientists have unmediated arguments in front of a public audience. I think that is discouraged within current advisory systems. Maybe the climate experience led to this. But even before that, in the 70s and 80s, there was this norm that scientists argue behind closed doors within scientific advisory committees, but then they present a united front when they give advice.

So theres one authoritative scientific advisory body, and that basically gives a consensus recommendation. So publicly-oriented scientific disagreement is seen to be something that undermines trust in science that emphasizing the uncertainty will mean anything goes, that scientists dont know anything. And I wanted to push back against that. I thought a properly organized institution, where scientists are facing one another directly, and not necessarily mediated by politicians who have their own agenda, and who just want to cherry-pick the science that serves it that could have healthy effects for clarifying the factual basis of this political decision making for the citizenry.

UD: When we think of scientists struggling to present a united front on a topic of great public interest, the current coronavirus pandemic certainly comes to mind. But you argue that a lot of those disagreements were hidden from view?

ZP: We saw this during the Covid-19 pandemic, with the masking advice in the U.S. It was initially presented as, This is our position: masks do not help; do not wear them. Fauci said this, the Surgeon General said this, [former White House adviser] Deborah Birx said this they were unanimous in this. And we did not hear from anybody within the scientific community.

And of course, debates were happening within the scientific community about the evidence for the benefits of masks, but we did not hear the opposing side: people saying Oh, masks are probably very effective, or at least, We dont know that masks are effective, and this is our level of uncertainty. We didnt hear the opposing view at all.

And I think that hurt the case, because it made the reversal very difficult; it made people not trust the masking advisory when it came in, in April 2020. So that was a good example of the kind of thing where a science court would have helped.

UD: But on the other hand, if the public had a greater window onto scientific arguments as they unfolded, maybe they just wouldnt listen to scientists at all. As you suggested, they might think, Oh, look they cant even agree among themselves.

ZP: Yeah, I think thats true. Thats the risk. If people see disagreement, they might think scientists cant agree. But that usually is the case. But the one thing I will say is, that when you see scientists disagreeing, you also see the scope of disagreement. For example, you dont see scientists saying vaccines are ineffective, or vaccines are hugely dangerous. So you see what sorts of things theyre disagreeing on, and that gives you a sense of where the debate is at.

If you overstate what scientists know, where the consensus lies, then there is a chance and this happens all the time that it will turn out to be wrong. And I think that undermines public trust even more than a candid admission that, at this point in time, scientists are disagreeing on a certain point.

UD: But, wouldnt having ordinary citizens act as arbiters in scientific disagreements bring us back to the issue of scientific literacy? For example, if some members of the public dont understand the difference between a virus and bacteria, then theyre in a very poor position to evaluate strategies for fighting infectious disease right?

ZP: Yes, I agree with that completely. I think improvements in scientific literacy would be critical for an institution like this to succeed. Then the question is, how much literacy? I think we can have a citizenry that is more literate about the scientific method, about the difference between viruses and bacteria. But that still wouldnt mean that theyd become experts, or that they would need to have a Ph.D. to participate in the science court.

Link:
Interview: Zeynep Pamuk on the Case for Creating Science Courts - Undark Magazine

It is understood the display contained a hula girl figurine - an object that has recently been criticised for presenting a stereotypical view of Polynesian people - and genetic studies relating to the San people in South Africa, who in 2017 devised a code of ethics for scientists studying them.

A spokesman for the museum said: The How did I get here? display in the Who Am I? gallery is currently covered while curators review content that is more than a decade old relating to migration, race and genetics which no longer reflects current scientific thinking.

We are planning to update the Who Am I? gallery on a rolling basis, where resource allows, to reflect areas where there has been fresh research or a shift in scientific understanding.

The changes follow the earmarking of the Who Am I? gallery for updates, with The Telegraph previously revealing that a cabinet on gender differences titled Boy Or Girl? was also up for review following complaints about a lack of mention of transgender.

The proposals were criticised by Maya Forstater, executive director of campaign group Sex Matters and winner of a prominent employment tribunal relating to her gender-critical views, who said: It is concerning that a place dedicated to science is being swayed by cultural trends in this way.

Sir Gregory Winter, the Nobel Prize-winning molecular biologist, said that influence from cultural trends was in some ways inevitable for scientific organisations

He told The Telegraph: Science is driven mainly by scientists seeking an understanding of ourselves, our world, and our past, our present and our future. It is also driven by scientists seeking to use this information for practical and - often commercial - purposes.

Inevitably scientists have had to engage with the public and with the zeitgeist.

For example, science has been shaped by the zeitgeist, as in the regulations relating to embryo research and the genetic engineering of organisms. Scientists have also shaped the zeitgeist - spectacularly with climate change.

As for museum curators, they also have to engage with the public and the zeitgeist. It is entirely possible to explain the same science in different ways to the public, and it is not unreasonable for curators to review their efforts in the light of new research or other considerations.

As far as I am concerned, the key test for a museum exhibit is whether it represents the underlying scientific consensus in a clear and engaging manner to a wide constituency.

I would have liked to use the word truth rather than consensus - but sometimes, as in evolutionary studies with sparse data, it may be impossible to establish a truth.

Of course, organisations should not pander too much, but they should engage.

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Science Museum boards up display on early human migration because it is 'non-inclusive' - Telegraph.co.uk

(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.

See more here:
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