The FDA calls out creators of genetically tweaked hornless bulls.
- Hornless bull clones turn out to have questionable genomes.
- Scientists were so confident they didn't even look for transgenic DNA.
- No one's sure what to do with the offspring.
The arrival of Spotigen and Buri<img type="lazy-image" data-runner-src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMTE2MTE1Ny9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY2NjYwNjgxOX0.HAQlx9IRCiyDWN3li6XgL52ZR79wmfNvDUhzC5cOobk/img.jpg?width=980" id="31095" class="rm-shortcode" data-rm-shortcode-id="b19d6c0ae8f91f802036bfab1c873ac9" data-rm-shortcode-name="rebelmouse-image" />
Image source: ANGHI/Shutterstock/Big Think<p>Recombinetics' bulls were heralded examples of gene modification's potential. Farmers regularly "poll" cows — that is, remove their horns— in a painful, difficult process aimed at preventing accidental injuries in herds and the humans that tend them.</p><p>The company used TALENs gene editing ("Transcription Activator-Like Effector Nucleases) to swap out a section of about 200 genes from a Holstein dairy bull for genes from a hornless one.</p><p>DNA editing involves cutting DNA with enzymes called nucleases targeted at the desired location in a cell's genome. Nucleases are proteins, which are hard to work with, so many researchers — including Recombinetics' — instead introduce plasmids, circular mini-chromosomes that code for the required "scissor." This causes the target cell to produce the nucleases itself, sparing the scientists the complexities of dealing with unstable protein.</p><p>In the case of Recombinetics' bulls, the plasmids also contained the replacement hornless DNA for insertion at the cut. Coming along for the ride — unknown to Recombinetics — was transgenic DNA, including the antibiotic-resistant genes and a handful of other things from a range of diverse microbes. This wouldn't necessarily have been a problem if the plasmids hadn't unexpectedly inserted themselves into the target cell's genome instead of simply delivering their payload and being done, as planned. Thus, adjacent to its edit site were <a href="https://www.independentsciencenews.org/health/gene-editing-unintentionally-adds-bovine-dna-goat-dna-and-bacterial-dna-mouse-researchers-find/" target="_blank">4,000 base pairs</a> of DNA that from the plasmid.</p>
Over-confident<img type="lazy-image" data-runner-src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMTE2MTE2MS9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY2NzQyMzE4MX0.efHCsAanKeIfxCvLNcK78iElNFV8f_-mpAlob5eeiEA/img.jpg?width=980" id="dc7ff" class="rm-shortcode" data-rm-shortcode-id="4af032e6384db1af6345d8d74d1b3331" data-rm-shortcode-name="rebelmouse-image" />
Image source: wikimedia/U.S. Food and Drug Administration<p>At the time the editing was first announced, Recombinetics was very confident that what they'd produced was "100% bovine." "We know exactly where the gene should go, and we put it in its exact location," claimed Recombinetics to <a href="https://www.bloomberg.com/news/articles/2017-10-12/this-genetics-company-is-editing-horns-off-milk-cows" target="_blank">Bloomberg</a> in 2017. "We have all the scientific data that proves that there are no off-target effects." In response to the latest findings, however, Tad Sontesgard of the Recombinetics subsidiary that owns the animals, admitted, "It was not something expected, and we didn't look for it." He acknowledges a more thorough examination of their work "should have been done."</p><p>Since genetically edited animals may be consumed, the FDA's position is that they likely require thorough testing and approvals. Recombinetics has publicly complained about such hurdles standing in the way of making animal genetic editing a routine occurrence. (They've also developed piglets that never hit puberty.) The company attempted to <a href="https://www.technologyreview.com/s/610027/farmland-gene-editors-want-cows-without-horns-pigs-without-tails-and-business-without/" target="_blank">convince the Trump Administration</a> to take genetically altered animals away from under the FDA.</p>
How the problem was found<img type="lazy-image" data-runner-src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMTE2MTE2NC9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTYyMDA3NzAyMX0.SBCvmAAsWaDYU7dkPQ7CgcrtQovHK-MWvOizZUCZqQg/img.jpg?width=980" id="43f50" class="rm-shortcode" data-rm-shortcode-id="6f28fb809a618ce4383b7cb4942805fb" data-rm-shortcode-name="rebelmouse-image" />
Image source: Moving Moment/Shutterstock<p>Not surprisingly, Recombinetics never applied for approval with the FDA, but Alison Van Eenennaam, their collaborator from University of California, Davis, did inform the FDA of their existence to facilitate exchanges of research insights and data.</p><p>Since the surviving edited cattle were being put up at Davis, Eenennaam started thinking about what to do with them. Incinerating experimental animals — and each of these weighs about a ton — costs 60 cents per pound. On the other hand, turning them into hamburger and steaks could reverse that cash flow. Her attempt to win the cows a food exemption from the FDA led to the discovery of the plasmids, though Sontesgard <a href="https://www.technologyreview.com/s/614235/recombinetics-gene-edited-hornless-cattle-major-dna-screwup" target="_blank">asserts</a> they'd be safe to eat in either case.</p><p>And then there's milk. Brazil agreed to raise the first herd of genetically modified hornless dairy cows. Regulators there had even determined no exceptional oversight was going to be required.</p><p>Soon a bioinformatician from the FDA stumbled across the plasmid in a bull's genome. It's estimated that about half of Buri's 17 offspring also have it in theirs. The cows are now absolutely classified as genetically modified organisms, GMOs, not pure cow. Brazil has backed out.</p>
Slowing their roll<img type="lazy-image" data-runner-src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMTE2MTE2OC9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY3MDc4MjgxMn0.BcON5gMT7I1eDHcwfc8bIB1zihjQkpE9UXwpbPiZke0/img.jpg?width=980" id="8ea26" class="rm-shortcode" data-rm-shortcode-id="0ad6c70f0e27fe6d94516a01cb5fb35f" data-rm-shortcode-name="rebelmouse-image" />
Image source: Sergey Nivens/Shutterstock<p> As science moves forward a few steps, it often has to back up a step or two. Glimpsing a solution, especially to such a complex problem as genome editing, isn't the same as having one fully in hand, no matter how attractive the reward of getting there first may be, or how much money is to be made. We're on the edge of a new frontier here, and there are a growing number of similar tales. Scientists do need courage to stretch the boundaries of the known, yes, but humility is also a good idea.</p>
The lawsuit might be right in disputing LaCroix's "all-natural" claim, but fans of the sparkling water probably don't have much to worry about.
- The lawsuit claims LaCroix's parent company is "intentionally misleading consumers" by claiming its drink is all natural.
- The lawsuit lists three "synthetic" chemicals used to make LaCroix, all of which the FDA classifies, in some way, as synthetic.
- However, these chemicals are all naturally occurring and there's no research that suggests they're harmful to humans in small amounts.
What's in LaCroix, anyway?<p>The LaCroix website says all its "natural flavors are essences or oils derived from the named fruit, i.e., lime/lime oils. There is nothing artificial in LaCroix — enjoy!" Still, few people can define what really constitutes an "essence."</p><p>That's partly because the Food and Drug Administration doesn't require companies to define the term, but allows them to use it to describe "flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, seafood, poultry, eggs, dairy products, or fermentation products thereof."</p><p>According to a<a href="https://www.wsj.com/articles/lacroix-fizzy-water-is-everyones-favorite-nobody-knows-whats-in-it-1505313912" target="_blank"> 2017 story about LaCroix</a> from <em>Wall Street Journal </em>reporter Rob Copeland, "Essence is, essentially, the mystery behind" the billion-dollar brand." A spokesperson for LaCroix told Copeland that "Essence is our picture word... Essence is — FEELINGS and Sensory Effects!"</p><p>Copeland conjured a more informative definition. "Essence is created by heating at high temperatures the skin, rinds or broken down remnants of fruits or vegetables," he wrote. "Alcohol is sometimes added to the mixture. The vapors that rise off the stew are captured, condensed and eventually sold by the 55-gallon barrel."</p><p>So, what about linalool and the other two supposedly artificial and dangerous chemicals found in <a href="https://markets.businessinsider.com/news/stocks/national-beverage-earnings-q4-2016-2017-3-1001820727" target="_blank">America's favorite seltzer</a>? </p><p>It's true that linalool is used in cockroach insecticide, but the chemical can also be found in dozens of spices recognized as safe by the FDA. The agency classifies <a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=182.60" target="_blank">both limonene and linalool</a> as "synthetic flavoring substances" that are "generally recognized as safe for their intended use," and <a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=172.515&SearchTerm=synthetic%20flavoring" target="_blank">lists linalyl proprionate</a> under "synthetic flavoring substances and adjuvants" that are safe, according to certain conditions.</p><p>It's also worth noting that there are varying definitions of the word "synthetic," and all three of these chemicals are naturally occurring substances that are added to LaCroix in relatively miniscule amounts, and, as such, likely aren't harmful to humans.<br></p><p>"It is very unlikely these naturally-occurring substances pose a health risk when consumed at levels usually found in foods," Roger Clemens, an expert in food and regulatory science at the University of Southern California, told <a href="https://www.popsci.com/lacroix-lawsuit-natural-synthetic-flavors" target="_blank"><em>Popular Science</em></a>. "If there were a health risk, then citrus juices and spices, such as curry, would not be consumed or be part of the commodity market."</p><p>Although sparkling water is known to be less than ideal for dental health, it's unlikely that products like LaCroix pose any real danger to humans. If anything, the (questionably) "all-natural" drink has probably helped many people become healthier as they transition from sugar-heavy soda to sparkling water. But for others, it's all about the taste.</p><p>"I know what flavors I like but I have no idea what kinds of chemicals are in there and I don't care," one LaCroix fan told Copeland. "I know it tastes good."</p>
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