US regulators clear path for genetically modified salmon
By CANDICE CHOI
AP Food & Health Writer
Friday, March 8
NEW YORK (AP) — U.S. regulators on Friday gave the green light to salmon genetically modified to grow about twice as fast as normal, but the company behind it may face legal challenges before the fish can be sold domestically.
The Food and Drug Administration said it lifted an alert that had prevented AquaBounty from importing its salmon eggs to its Indiana facility, where they would be grown before being sold as food. The agency noted the salmon has already undergone safety reviews, and that it lifted its alert because the fish would be subject to a new regulation that will require companies to disclose when a food is bioengineered.
The move comes despite a pending lawsuit filed by a coalition of consumer, environmental and fishing groups that challenged the FDA’s approval of the fish.
“We think a remedy in our case would stop sale of the fish before they’re allowed to be sold,” said George Kimbrell, legal director for the Center for Food Safety, one of the groups suing the FDA.
AquaBounty was founded in 1991, and it has been working through years of safety reviews and regulatory hurdles to sell its fish in the United States. In 2015, its salmon became the first genetically modified animal approved by the FDA for human consumption. But the agency subsequently issued an alert that stopped the Maynard, Massachusetts-based company from importing its fish eggs until disclosure guidelines for genetically modified foods were resolved.
Called AquAdvantage, the fish is Atlantic salmon modified with DNA from other fish species to grow faster, which the company says will help feed growing demand for animal protein while reducing costs.
AquaBounty CEO Sylvia Wulf said the company expects to get a final certification for its Albany, Indiana, growing facility in the coming weeks. Salmon eggs could then be sent from the company’s research and development facility in Canada, and would be harvested after about 18 months when they reach 10 pounds, she said.
Wulf said it’s been difficult to engage companies in sales discussions because AquaBounty didn’t know when it could start growing the fish in the United States. She said the salmon already has been sold in limited quantities in Canada, where it doesn’t have to be labeled as genetically modified. Wulf said she doesn’t expect the pending lawsuit to affect the company’s U.S. plans.
The genetically modified salmon are raised in tanks and bred to be female and sterile, measures designed to address any fears that they might get into the environment and breed with wild fish.
But Kimbrell, of the Center for Food Safety, said the company’s own tests have shown it’s not 100 percent certain the fish would be sterile, and that concerns about it getting in the environment would grow if the company’s operations were to expand.
He also noted the disclosure regulation uses the term “bioengineered,” even though most people are more familiar with the term genetically modified. And he pointed out that companies can provide disclosure through codes that have to be scanned.
Implementation of that regulation starts in 2020, though people may start seeing disclosures on packages sooner. Compliance becomes mandatory in 2022.
The genetic modification for AquaBounty’s fish is different from gene-editing technology, which lets scientists snip out specific genes to bring about traits without introducing foreign DNA. Companies are also working to develop a variety of gene-edited crops and animals .
Follow Candice Choi at www.twitter.com/candicechoi
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
Point: Finally, There Will Be an Objective Federal Climate Commission
By H. Sterling Burnett
If media speculation is to be believed, President Trump will soon form a Presidential Commission on Climate Security (PCCS). A PCCS is long overdue, and award-winning physicist William Happer, Ph.D., the administration’s senior director of the National Security Council office for emerging technologies, is the perfect person to run it.
As the name implies, the United Nations’ Intergovernmental Panel on Climate Change (IPCC) is a political — not scientific — organization, and that’s been true from its inception. In fact, the panel was charged specifically with examining the “human causes” of climate change.
The climate is complex, with myriad factors — including the sun, ocean currents, volcanic activity and land-use alterations — contributing to changes in climate. Therefore, one can’t accurately understand the climate if one is directed to study only one aspect of it (humans’ involvement).
Since IPCC was formed in 1988, many scientists have advanced their careers and raked in big government research grants by towing the party line, which insists humans are causing dangerous climate change and only a government takeover of the economy — something like Rep. Alexandria Ocasio-Cortez’s (D-New York) “Green New Deal” — can fix it. Time and again, climate data have been manipulated and research questioning whether humans are causing dangerous climate change has been suppressed or ignored, all to make the facts conform to the theory.
Now, more than ever, we need a truly scientific debate regarding the causes and consequences of climate change, and the Happer-led Presidential Commission on Climate Security is the perfect opportunity for that to occur.
Happer has had a distinguished career in academia and in government service. He was the Cyrus Fogg Brackett professor of physics, emeritus, at Princeton University. He also served as the director of the Office of Energy Research at the U.S. Department of Energy and is currently a fellow of the American Association for the Advancement of Science and a member of the National Academy of Sciences.
The highly qualified scientists that will make up PCCS, absent political interference or pressure, will finally be able to examine and debate objectively the full panoply of climate change causes and its purported effects on national security, agriculture, sea level and extreme weather.
Happer has written extensively on two critical aspects of climate change science: the need for quality data and the potential benefits from increased carbon dioxide.
In 2015, Happer assembled a group of more than 300 experts to sign a letter delivered to the U.S. House Committee on Science, Space and Technology critiquing scientists at the National Oceanic and Atmospheric Administration for rushing into publishing research claiming there had been no extended hiatus in rising global temperature. This claim conflicted with every extant temperature database and the findings of many organizations worldwide, including the IPCC, that concluded there had been a lengthy hiatus in global warming.
An extraordinary claim like NOAA’s demanded extraordinary proof and careful vetting. However, the opposite occurred, because NOAA violated the 2001 Data Quality Act by failing to follow proper procedures that would have ensured their data were carefully catalogued and verified for accuracy. NOAA threw science aside for political reasons: to get their research published in time to influence the Paris Climate Agreement negotiations.
Since the announcement of the PCCS, the liberal media has been hyperventilating over Happer’s statements indicating that IPCC’s temperature estimates for a doubling of carbon dioxide emissions are too high and that the modest warming that might be created by additional carbon dioxide would be modest and largely beneficial. Indeed, Happer has argued agriculture will benefit from additional carbon dioxide, which is critical to photosynthesis. As carbon dioxide concentrations have increased, crop yields have set records, plants have become more tolerant to drought, and some desert regions are greening.
These claims have made climate alarmists apoplectic, even though thousands of experiments and the actions of greenhouse operators worldwide confirm Happer’s assertions on the agricultural benefits of higher carbon dioxide concentrations and a modest warming of Earth.
For climate alarmists — and the mainstream media, which has adopted their cause — Trump’s big sin is allowing PCCS to question the claim that climate science is settled. Happer’s big sins are that he defends the need for transparent, high-quality data and he points out a modestly warmer world will bring benefits as well as costs. All the panic, gnashing of teeth, wailing and name-calling concerning PCCS comes down to this.
To advance climate science and develop sound policy, an unbiased examination and debate of the facts about climate change are necessary. This is hardly an anti-science conspiracy, and Americans deserve the work PCCS will perform with Happer at the helm.
ABOUT THE WRITER
H. Sterling Burnett (email@example.com) is a senior fellow on energy and the environment at The Heartland Institute. He wrote this for InsideSources.com.
Counterpoint: Trump Waging a War on Science
By Ben Schneider
For the third time in as many years, President Trump has proposed a federal budget that slashes funds for the Environmental Protection Agency by 30 percent. Public health officials, climate scientists and other scientific experts have long warned about the dire consequences for human and environmental health that would result from a grossly underfunded EPA. And as he has since the earliest days of his administration, Trump is ignoring them.
The Trump administration’s open contempt of science and facts, and scientific institutions in America and the world over, is hardly limited to EPA — Trump’s budget proposal also called for draconian cuts to the National Science Foundation, NASA, the National Institute of Standards and Technology and many more.
But Trump’s relentless attacks on the environment are particularly brazen. He routinely spreads false information about climate change. He has hired industry insiders and lobbyists for essential EPA positions. And his attacks on public health and environmental safeguards are so extreme as to arouse opposition even from industry.
Among his transgressions:
—He appointed a former coal lobbyist to lead the EPA.
—He appointed to a top EPA scientific advisory position a toxicologist who argued with a straight face that air pollution isn’t harmful.
—He has appointed former oil and gas lobbyists to key advisory posts in his administration.
—He appointed a prominent climate change denier to lead EPA’s transition team.
The American Pediatric Association warns that mercury pollution can cause birth defects and brain damage in children. Trump’s EPA put children’s health at risk by attacking mercury rules for power plants. Every major power company association opposes the attack.
A diverse coalition of science and environmental groups has voiced strong support for maintaining clean car standards in the United States that lower pollution, all while saving American families money. Trump is ignoring their advice and moving to roll back the rules. Even auto manufacturers are raising concerns with his decision.
EPA and other federal agencies rely on the counsel of scientific experts to ensure policies are developed with sound science. Trump is eliminating essential science positions at EPA and other agencies.
Trump’s indifference to the consequences of human exposure to chemical hazards is readily apparent in his administration’s woefully inadequate implementation of the Toxic Substances Control Act.
Trump’s disregard for climate science is even more pronounced. Every major scientific organization in America — NASA, the American Medical Association, the American Meteorological Association, to name just a few — all agree climate change is real and caused by human activity. But Trump appears unmoved, and claims he does “not know if it’s manmade.” He routinely dismisses the increasingly dire climate reports released by the nation’s top climate scientists. His administration has even gone so far as to scrub mentions of climate change from federal agency websites.
It is hard to overstate how much Americans need strong environmental protections to protect human health. Up to 10 million homes across America still get their drinking water through lead pipes — in Flint, Michigan, and across the nation.
According to the American Lung Association, 125 million Americans live in counties with unhealthy air quality. We need more, better protection from pollution, not less — especially children, the elderly and others who are particularly vulnerable to the dangers of pollution.
Meanwhile, recent reports from top scientific organizations make it abundantly clear that aggressive action is needed to address climate change.
All of these pressing environmental problems continue to be ignored by the White House. And so long as Trump remains president, we can expect attacks on science-based environmental safeguards to continue. That’s why we need Congress to roundly reject his proposed cuts to EPA and fully fund this agency that is tasked with protecting human and environmental health.
Settled science should transcend politics. Americans deserve environmental protections based on sound science. Anything less is unethical, and unacceptable.
ABOUT THE WRITER
Ben Schneider is senior communications manager for Environmental Defense Fund. He wrote this for InsideSources.com.
Your pet on pot, or even CBD: Not a good thing, a vet toxicologist explains
March 21, 2019
Author: John P. Buchweitz, Toxicology and Nutrition Section Chief, Michigan State University
Disclosure statement: John P. Buchweitz does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.
Partners: Michigan State University provides funding as a founding partner of The Conversation US.
My family and I were on vacation in Florida recently and took advantage of a free afternoon to do some gift shopping for local memorabilia – not your ordinary T-shirts and key chains. Our adventure took us to St. Armand’s Key, part of Sarasota, and the many unique shops there.
While meandering between shops around the outdoor circle, my daughter, 14, was often quick to ask the locals, “Can I pet your dog?” She was missing her dog, Belle, who was being boarded back home and thought it would be a good idea to get her something too.
In our efforts to find Belle a gift, we stumbled upon the most unlikely of shops – a store that proudly advertised CBD (cannabidiol) for you and your pets. CBD is a chemical derived from the cannabis plant, but it does not contain THC, the chemical in pot that makes people high. Nonetheless, CBD appears to be the molecule of the moment after the Food and Drug Administration approved a drug in June 2018 that contains a CBD derivative to treat some forms of epilepsy.
Now, in all honesty, I was quite hesitant to make my way in, but there were quite a few dogs and their owners entering and exiting with various products – not all appearing to be CBD-related. So, I looked at my wife and said, “Why not?”
As a board-certified toxicologist at a major veterinary diagnostic laboratory, I have had experience working with a broad spectrum of poisoning incidents in all types of animals, including our companions. Recently, our lab has seen an increase in the number of positive tests for marijuana in dogs, many of whom may have accidentally ingested edible forms of marijuana. The American Society for the Prevention of Cruelty to Animals has reported a more than 700 percent increase in calls related to marijuana to its poison center in 2019.
As a dad and as a toxicologist, I welcomed the idea of answering my daughter’s questions about CBD and other chemicals in marijuana that are making their way to our pets. But, of course, I had to start with providing her with some context.
‘Why would people give it to their pets?’
Several items caught my daughter’s attention and, of course, she chuckled with amusement. In that moment, though, she began to ask some great questions: “What is CBD and hemp, and why would people give it to their pets?”
I first reminded her of the most recent election. In 2018, we saw the number of states that legalized marijuana for medical and recreational use expand to 33, including our home state, Michigan. Because of this legalization, there was also a marked expansion in the quantity and types of marijuana-related products available to people and pets, including hemp and CBD oils and pet treats.
So, what is the difference and significance of these products? Marijuana – also known as Cannabis sativa – is comprised of somewhere between 66 and 113 different cannabinoid compounds. Of these, recreational use of marijuana is sought after for the psychotropic “high” produced by delta-9-tetrahydrocannabinol, or THC. Humans either smoke marijuana or convert it into butters or oils for baked products – most notable of these are the often joked about “brownies” – or other edibles such as candy, or they may use the oil itself.
These edible formulations are more problematic for our household companion animals as these are more likely to contain higher concentrations of THC. And, they often include other ingredients that may independently cause harm to your pet such as chocolate, sugar and xylitol, a sugar substitute.
We have received cases at the veterinary diagnostic laboratory in which animals have been either inadvertently or intentionally exposed to marijuana products.
THC is known to be toxic to dogs. According to the Merck Veterinary Manual, common signs of marijuana toxicosis that owners may notice include inactivity; incoordination; dilated pupils; increased sensitivity to motion, sound or touch; hypersalivation; and urinary incontinence. A veterinary exam can reveal depression of the central nervous system and an abnormally slow heart rate. Less common signs include restlessness, aggression, slow breathing, low blood pressure, an abnormally fast heart rate, and rapid, involuntary eye movements. In rare cases, animals can have seizures or become comatose.
Hemp differs from marijuana in that it has a significantly lower THC content with predominantly more CBD. In a sense, this lessens the chances that an individual or pet will experience the negative side effects of THC, as CBD doesn’t exert the same psychoactive potential. However, there are no regulations on the chemical makeup of hemp products and therefore no way of really knowing, apart from relying on manufacturers’ labels for batch-to-batch variability in THC content. Additionally, very little is known regarding the long-term health effects of chronic exposure to these products, or about their use in conjunction with other medications.
Last, many CBD oils have claims of even higher purity than hemp. Similarly, though, these products are not regulated and therefore may still exhibit variability in chemical makeup. Additionally, many of the claims about cannabinoids’ effectiveness are anecdotal and have not yet been scientifically proven. This means that doctors of humans and animals remain somewhat skeptical about the potential benefits to their patients.
Why you shouldn’t give pot to your pets
So, why do people give these products to their pets?
For marijuana itself, my answer to my daughter was blunt. It is simply ignorance, or an abusive behavior that spawns from negligence. There are no good reasons to give your pet a “high” regardless of whether the product is legal for human medical or recreational purposes.
Pets are not people. Many prescription and over the counter drugs as well as foods that are safe for humans are not safe for pets. For example, alcohol is also toxic to pets and while some owners may think it’s funny to let their pets drink their beer or liquor, it can in fact be quite dangerous for the animal.
As for hemp and CBD oils – as a toxicologist, I am skeptical at best.
It is difficult to watch our pets suffer through anxiety or pain from ailments such as cancer. However, although these products have been touted for their therapeutic potential, none of them have gone through the rigor of an FDA approval. Anecdotal findings and limited case studies in humans do not constitute the wealth of information that is needed to establish these products as “safe” for our pets.
For people, there is an inclination to deem products that originate from plants as being “natural,” and thus rather arbitrarily “safe.” This, too, can be harmful. Simply put, “natural” does not always equal “safe.”
There is something to be said about the doctor-patient relationship in treating the whole patient – this goes for pets and their veterinarians as well. When we choose to use supplements, this needs to be disclosed to a licensed professional so as to allow for conversations about risks and continued health monitoring. It is not wise to bypass our trained professionals for the ill-trained Dr. Google.
As I continue to see more of these products show up in veterinary diagnostic samples, our interpretations will continually be guided by future scientific studies and case-based outcomes. Hopefully, a fuller understanding of these products and their associated benefits and risks will be had.
As for Belle – we purchased her a brightly colored new collar.
Joe Dirk: My friends have a dog that has had a large tumor on her right rear buttocks since she was 1 ½. Various vets have looked at it and cannot find a solution. Surgery has not worked. The dog was given six months to live by all the vets. That was 6 years ago.
My friends had researched CBD oils and started their dog on a diet that included these oils. The tumor stays at a minimum size and does not affect the dog’s movement nearly as much as it used to. The vets all agree that the CBD oil has been the saving grace. There is absolutely no toxic build up in the dogs system.
You just need to know that the CBD oil you are getting is pure, and that is not difficult at all to determine. Don’t buy the oil from discount internet sites. That is the same as buying moonshine from a backyard still – you don’t know what impurities might be in it. Only buy it from a certified source. Vermont has a private company that will test the oil for you and issue a certification based on the results. MY friends make their own oil these days. All you need is a license to grow hemp ($50), a hot press machine ($100), and six months to let the hemp grow.
Jonathan Giacomini: This article was a huge waste of time.