Will More GMO Foods Be Approved Under FDA’s New Leadership?
By Ana Santos Rutschman
The world of food and drug regulation was rocked earlier this month by the news of a change in leadership at the Food and Drug Administration. Commissioner Scott Gottlieb resigned and will step down in early April. His temporary replacement is Dr. Ned Sharpless, director of the National Cancer Institute.
Most of the attention surrounding Gottlieb's departure has focused on the consequences of the resignation for the vaping and tobacco industries. But the impact of changes in FDA leadership extends well beyond that. FDA-regulated products make up 20 percent of consumer spending in the U.S. In the realm of food alone, FDA regulates 75 percent of our food supply.
As a professor who studies FDA and health law at Saint Louis University, I have been working with the Center for Health Law Studies to monitor changes in FDA regulations and policies. Most recently I've been tracking progress on the FDA's regulation of genetically modified food and think I can explain what consumers can expect from the agency after Gottlieb departs.
How the FDA Deals With GM Plants and Animals
Genetically modified plants entered the U.S. market in the 1990s. Since then, the official FDA position has been that food derived from genetically modified plants and animals is not different "from other foods in any meaningful or uniform way." This includes considerations regarding safety and long-time effects associated with its consumption.
Many people regard genetically modified food as a means to feed more people at a lower cost. However, recent studies suggest that these promises remain unfulfilled since genetically engineered food first became available in the 1990s.
Even though scientists have been able to alter the genome of animals for decades, it was not until 2008 that the FDA issued guidance on genetically modified animals. Since then, the agency has become much more active in this area. In 2017, months before Gottlieb became commissioner, the FDA issued further guidance on the use of emerging technologies, like CRISPR, that allow scientists to alter animal genomes.
As with plants, the FDA considers genetically engineered animals safe for human consumption. The agency reviews these types of products as new animal drug applications.
In 2015, two years before Gottlieb began his tenure, the FDA favorably reviewed an application involving AquAdvantage salmon. Although AquAdvantage salmon was being produced in Canada in 2016, Congress directed FDA to restrict importation of AquAdvantage salmon into the U.S. This genetically modified fish incorporates a growth hormone gene from Chinook salmon and links it to a genetic switch, or promoter. The promoter taken from an eel-like fish called ocean pout keeps the growth hormone gene in the "on" position, allowing it to grow significantly faster than comparable Atlantic salmon.
Gottlieb's FDA and Regulation of GE Food
As a response, on March 8, 2019, Gottlieb's FDA reversed the regulation prohibiting the importation of AquAdvantage salmon. With this decision, FDA underscored the agency's belief that the product is safe for humans.
In addition to endorsing the general safety of genetically engineered foods, Gottlieb's official statement highlights the FDA's goal of explicitly assuring consumers that genetically engineered foods available in the U.S. market "meet the FDA's high safety standards."
In many ways, the response of the agency can be seen as purely mechanical and deferential to USDA and Congress. But I think it also signals continuity of a permissive policy when it comes to genetically engineered food. By treating it the same way it treats traditional food, the FDA will intervene if genetically engineered food is contaminated or prepared under unsanitary conditions, as it normally does under its general mandate as an agency tasked with protecting the public health.
The FDA's behavior in this field is in line with the current scientific consensus in the U.S. and abroad. Numerous reputable institutions have upheld the safety of genetically engineered food. These include the National Academy of Sciences and the World Health Organization. Nevertheless, there are some critics of this consensus who call for more research into the long-term effects of eating genetically modified food. According to recent data, consumers continue to distrust genetically engineered food as well.
GM Food Under Sharpless and Beyond
I believe that in the near future, FDA will address this distrust while continuing to guide the industry as different types of genetically engineered food enter the market.
Right now, we know virtually nothing about the views of the incoming acting commissioner on genetically engineered food, or food regulation in general. I think the most likely scenario is that Sharpless' FDA will not stray from its current path regarding genetically engineered food. In 2018, Gottlieb launched a Plant and Animal Biotechnology Innovation Action Plan, describing a public communication strategy to engage stakeholders. The plan includes public webinars on animal genome editing, as well as guidance on plant and animal biotechnology. Given the current scientific consensus, it would be surprising if Sharpless chose to move the agency in a different direction.
On the labeling front, now that FDA has relinquished most of its authority in this matter to the USDA, the debate is likely to shift elsewhere. Already under Gottlieb, much energy was spent on labeling issues involving almond milk and vegan cheese. The agency worried that using dairy names to described plant-based products might be confusing to consumers.
It is of course possible that Sharpless will not be at the helm of FDA for very long. After all, he is an interim figure of Democratic leanings. However, given FDA's improbable recent history, there is reason to expect some institutional continuity in the foreseeable future.
Consumers should therefore count on increasing numbers of genetically modified plants and animals entering our food supply. Absent a change in scientific consensus, FDA will smooth the pathway for companies to bring these products to market.
#FDA Puts U.S. Consumers at 'Serious Risk' by Allowing GE #Salmon 'Frankenfish' Imports https://t.co/V5h9FUuteQ @commondreams @truefoodnow— EcoWatch (@EcoWatch)1552881303.0
Ana Santos Rutschman is an assistant professor of law at Saint Louis University.
Disclosure statement: Ana Santos Rutschman 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 her academic appointment.
Reposted with permission from our media associate The Conversation.
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By Alex Kirby
The temperature of the Arctic matters to the entire world: it helps to keep the global climate fairly cool. Scientists now say that by 2035 there could be an end to Arctic sea ice.
Melt Ponds Crucial<p>"The prospect of loss of sea ice by 2035 should really be focusing all our minds on achieving a low-carbon world as soon as humanly feasible."</p><p><a href="http://www.reading.ac.uk/search/search-staff-details.aspx?id=10813" target="_blank">Dr. David Schroeder from the University of Reading</a>, UK, who co-led the implementation of the melt pond scheme in the climate model, says, "This shows just how important sea ice processes like melt ponds are in the Arctic, and why it is crucial that they are incorporated into climate models."</p><p>The extent of the areas <a href="https://nsidc.org/cryosphere/seaice/characteristics/formation.html" target="_blank">sea ice</a> covers varies between summer and winter. If more solar energy is absorbed at the surface, and temperatures rise further, a cycle of warming and melting occurs during summer months.</p><p>When the ice forms, the ocean water beneath becomes saltier and denser than the surrounding ocean. Saltier water sinks and moves along the ocean bottom towards the equator, while warm water from mid-depths to the surface travels from the equator towards the poles.</p><p>Scientists refer to this process as the ocean's global "conveyor-belt." Changes to the volume of sea ice can disrupt normal ocean circulation, with consequences for global climate. </p>
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Russia's Health Ministry has given regulatory approval for the world's first COVID-19 vaccine after less than two months of human testing, President Vladimir Putin said on Tuesday.
Putin's Daughter Among Vaccinated<p>The Russian leader also said that one of his daughters has already been inoculated and is feeling well.</p><p>"One of my daughters got vaccinated, so in this sense, she took part in the testing," Putin said.</p><p>After the first vaccine shot, his daughter experienced a slight fever, 38 degrees Celsius (100.4°F). Her temperature came down to just slightly above normal the next day. </p><p>"After the second shot, she had a slight fever again, and then everything was fine. She is feeling well and has a high antibody count," Putin said. </p><p>He didn't specify which of his two daughters, Maria or Katerina, received the vaccine.</p><p>Russian health authorities have said that medical workers, teachers and other risk groups will be the first to receive shots of the vaccine.</p>
Years of Work Reduced to Weeks<p>Russia is the first country to register a COVID-19 vaccine. As <a href="https://www.dw.com/en/germany-coronavirus-vaccine-may-only-be-available-in-mid-2021/a-54362065" target="_blank">countries worldwide race to produce the first vaccine</a>, health experts warn that speed and national pride could compromise safety.</p><p>Scientists in Russia and abroad have questioned Moscow's decision to register the vaccine before Phase 3 trials that normally last for months and involve thousands of people, but Putin emphasized that the vaccine underwent the necessary trials and that vaccination will be voluntary.</p><p>Russian officials have said that large-scale production of the vaccine will begin in September, and mass vaccination may start as early as October.</p><p>Philippine President Rodrigo Duterte, meanwhile, has <a href="https://www.dw.com/en/philippines-duterte-volunteers-to-be-putins-russian-coronavirus-vaccine-guinea-pig/a-54523030" target="_blank">lauded Russia's efforts in developing the vaccine</a> and said that the Philippines is ready to work with Moscow on vaccine trials, supply and production. Duterte volunteered to "be the first they can experiment on."</p><p>"I will tell President Putin that I have huge trust in your studies in combating COVID and I believe that the vaccine that you have produced is really good for humanity," Duterte said, adding that he thinks Russia's vaccine will be ready for the Philippines by December.</p>
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By Arkilaus Kladit
My name is Arkilaus Kladit. I'm from the Knasaimos-Tehit tribe in South Sorong Regency, West Papua Province, Indonesia. For decades my tribe has been fighting to protect our forests from outsiders who want to log it or clear it for palm oil. For my people, the forest is our mother and our best friend. Everything we need to survive comes from the forest: food, medicines, building materials, and there are many sacred sites in the forest.
Map of the Knasaimos traditional lands.
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By Farah Aqel
Overthinkers are people who are buried in their own obsessive thoughts. Imagine being in a large maze where each turn leads into an even deeper and knottier tangle of catastrophic, distressing events — that is what it feels like to them when they think about the issues that confront them.
Ruminating<p>According to the late Susan Nolen-Hoeksema, a professor of psychology at Yale University, <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5796420/" target="_blank">ruminating</a> involves replaying a problem over and over in your mind. We ruminate by obsessing over our thoughts and thinking repetitively about various aspects of a past situation.</p><p>It usually involves regret, self-loathing and self-blaming. Rumination is associated with the development of depression, anxiety and eating disorders. </p><p>People prone to such patterns of thought may, for example, overanalyze every single detail of a relationship that breaks up. They often blame themselves for what has happened and are overcome with regret, with typical thoughts being: </p><p>- I should have been more patient and more supportive. </p><p>- I have lost the most perfect partner ever. </p><p>- No one will love me again.</p>
Worrying<p>Worrying is wanting to predict the future. It involves negative thoughts about things that might and might not happen.</p><p>- They'll not like me in the interview; they'll not give me the job. </p><p>- I haven't heard back from other employers. How long will I be unemployed?</p><p>These thoughts are energy-draining and distressing. They could happen to anyone under stress. But when you reach the point where your thoughts and worrying are preventing you from doing what you want to do — from living your life to the fullest — then you should take action.</p>
Catch Yourself Overthinking<p>Reuben Berger, a psychotherapist at the university hospital in the western German city of Bonn, recommends several practical steps that you could employ in your daily routine when you catch yourself worrying or ruminating.</p><p>One effective remedy, says Berger, is the <a href="https://www.uofmhealth.org/health-library/uf9938" target="_blank">thought-stopping technique.</a></p><p>"When the negative thoughts come or ruminations start, you say to yourself: 'Stop!,'" he says, adding that it is more effective when you actually say the word out loud.</p><p>He even recommends having a rubber band around your wrist to ping against yourself while saying the word. Adding a visual component by imagining a stop sign also makes the technique more powerful, he says.</p><p>The main idea here is conditioning yourself to stop the loop of worrying (making future predictions) or rumination (obsessing over past events).</p><p>Berger says the technique could take up to two weeks to take effect and that it needs to be practiced every day. "Consistency is very important," he says. </p>
Thoughts Are Just Thoughts<p>Another way of dealing with negative thoughts often used in modern therapy is realizing that thoughts aren't facts, says Berger.</p><p>He says it is important when we think something to ask: Is that real? Did that really happen? What is the worst thing that could happen?</p><p>Flight anxiety is one example where untrue thoughts are accepted as facts. Although air travel is the safest way to get around, people suffering from fear of flying accept their thoughts and fears as reality, then act upon them by refusing to fly.</p>
Mindfulness<p>Berger also recommends the use of mindfulness techniques, in which attention is paid to experiences in the moment without judging them, as a way of reducing worrying.</p><p>"Mindfulness helps you to distance yourself from your thoughts and to be more present in the moment," he says.</p><p><a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3432145/#R2" target="_blank">Several studies</a> have shown that mindfulness has a positive impact on reducing stress-related behaviors such as rumination and worrying, as focusing on the moment makes anxiety about other problems impossible.</p><p>Mindfulness can be practiced during routine activities by paying attention to your body and your surroundings. For instance, when you leave for work in the morning, you can focus on sensing the breeze, listen attentively to birds, feel the gravel under your feet and monitor your breath. </p>
Trick Your Brain Into Happiness<p>People plagued by obsessive thoughts do not always choose healthy ways like mindfulness to distract from them, however.</p><p> Dr. Edward Selby, a psychologist at Florida state university, has shown in a study that people try to avoid rumination by engaging in a range of uncontrolled behaviors, such as binge eating and substance abuse.</p><p>But he says that a much better way to overcome such distress is by distraction and shifting attention away from problems that are obsessing us.</p><p>There are many activities that can be used to distract from rumination, he says, and people should choose the one that works best for them. Here are some examples:</p><p>- Listen to music</p><p>- Read a book</p><p>- Take a hot shower</p><p>- Dance or exercise </p><p>- Talk to a friend (not about the problem)</p><p>- Watch a movie</p><p>- Mindfulness meditation</p>
Changing the Perception of Events<p>The way people perceive a situation largely influences their emotions and behavior. It is not the situation itself that determines how they feel, but rather the way they interpret it.</p><p>Reframing negative thoughts can lead to positive emotions and, subsequently, healthier behaviors — including a reduction in damaging overthinking and worrying.</p><p>Cognitive behavioral therapy (CBT) is currently a gold standard in psychotherapy. CBT aims to change the way people think and act. It largely involves challenging unhelpful beliefs or attitudes such as overgeneralization — thinking "I always fail at public speaking" when you have had one bad experience in front of an audience, for example — or "catastrophization," i.e., imagining the worst possible outcome to a situation. </p><p>A psychotherapist can teach people how to implement such thought-changing techniques into their lives. Techniques vary depending on their issues and goals.</p>
Solutions Are at Hand<p>Try to find ways of avoiding worrying, rumination and overthinking that make you feel most comfortable.</p><p>Incorporating any routine in your life when you're stressed isn't an easy task, but you can do it! If you feel overwhelmed, you can always seek professional help. </p><p><em>If you are suffering from serious emotional strain or suicidal thoughts, do not hesitate to seek professional help. You can find information on where to find such help, no matter where you live in the world, <a href="https://www.befrienders.org/" target="_blank">at this website.</a></em></p>
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