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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The European Court of Human Rights said the case, which accuses 33 European nations of violating the applicants' right to life by disregarding the climate emergency, would be granted priority status due to the "importance and urgency of the issues raised."
‘Protect Our Future’<p>Cláudia Agostinho (21), Catarina Mota (20), Martim Agostinho (17), Sofia Oliveira (15), André Oliveira (12) and Mariana Agostinho (8) are <a href="https://www.desmogblog.com/2020/09/03/youth-climate-lawsuit-portugal-33-european-countries" target="_blank">bringing the case</a> with nonprofit law firm Global Legal Action Network (<span style="background-color: initial;">GLAN</span>), arguing that none of the countries have sufficiently ambitious targets to cut their emissions.</p><p>Portugal recently sweltered through its <a href="https://www.ipma.pt/pt/media/noticias/news.detail.jsp?f=/pt/media/noticias/textos/resumo-clima-julho-20.html" target="_blank">hottest July in 90 years</a> and has seen a rise in devastating heatwaves and wildfires over recent years due to rising temperatures. Four of the applicants live in Leiria, one of the regions worst-hit by the forest fires that killed more than 120 people in 2017. </p><p>Responding to the development, André Oliveira, 12, said: "It gives me lots of hope to know that the judges in the European Court of Human Rights recognise the urgency of our case." </p><p>"But what I'd like the most would be for European governments to immediately do what the scientists say is necessary to protect our future. Until they do this, we will keep on fighting with more determination than ever."</p>
‘Highly Significant'<p>The decision represents a "highly significant" step, <a href="https://www.glanlaw.org/about-us" target="_blank">GLAN</a> Director Dr. Gearóid Ó Cuinn said in a <a href="https://youth4climatejustice.org/" target="_blank">press release</a>.</p><p>"This is an appropriate response from the Court given the scale and imminence of the threat these young people face from the climate emergency," he added. </p><p>By suing the 33 countries all together, the youths aim to compel these national governments to act more aggressively on climate through a single court order, which would potentially be more effective than pursuing separate lawsuits or lobbying policymakers in each country.</p><p>If successful, the defendant countries would be legally bound not only to ramp up emissions cuts, but also to tackle overseas contributions to climate change including those of their multinational enterprises.</p>
‘Major Hurdle’<p>The <a href="https://youth4climatejustice.org/the-case/" target="_blank" rel="noopener noreferrer">countries targeted</a> include all of the European Union member states as well as Norway, Russia, Switzerland, Turkey, Ukraine and the United Kingdom, none of which are currently aligned with <a href="https://www.ecowatch.com/tag/paris-agreement">Paris agreement</a> target to limit global temperature rise to well below 2 degrees C (3.6 degrees F) and pursue a limit of 1.5 degrees C (2.7 degrees F).<a href="https://climateactiontracker.org/countries/" target="_blank" rel="noopener noreferrer"> </a></p><p><a href="https://climateactiontracker.org/countries/" target="_blank" rel="noopener noreferrer">Climate Action Tracker rates</a> most of Europe as "insufficient" in terms of its emissions reduction policies based on the Paris target, while Ukraine, Turkey and Russia are assessed as "critically insufficient" – meaning they are on track for a warming of 4 degrees C or higher.</p><p>The European Union has pledged to slash its emissions by <a href="https://ec.europa.eu/clima/policies/eu-climate-action/2030_ctp_en" target="_blank" rel="noopener noreferrer">at least 55 percent by 2030</a>. But the Portuguese youth plaintiffs are calling for cuts of at least 65 percent by 2030, a level that <a href="http://www.caneurope.org/energy/climate-energy-targets" target="_blank" rel="noopener noreferrer">European climate campaigners say</a> is necessary to meet the 1.5 degrees warming limit.</p><p> The 33 countries must each respond to the youths' complaint by the end of February, before lawyers representing the plaintiffs will respond to the points of defense. </p><p>"Nothing less than a 65 percent reduction by 2030 will be enough for the EU member states to comply with their obligations to the youth-applicants and indeed countless others," Gerry Liston, legal officer with GLAN, said in a press release.</p><p>"These brave young people have cleared a major hurdle in their pursuit of a judgment which compels European governments to accelerate their climate mitigation efforts."</p><p><span></span><em>Reposted with permission from <a href="https://www.desmogblog.com/2020/11/29/court-advances-landmark-youth-climate-lawsuit-against-33-european-nations" target="_blank">DeSmog</a>. </em></p>
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