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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When they founded their recycling start-up Plaxtil in 2017, it was textile waste they set their sights on. The project developed a process that turned fabrics into a new recyclable material they describe as "ecological plastic."
Mounting Piles of Waste<p>It is not only the streets of Chatellerault where pandemic pollution is piling-up, but also the world's beaches and oceans. Once there, they can take up to 450 years to degrade and disappear.</p><p>Esther Röling, co-organizer of the annual Adventure Clean Up Challenge held on Hong Kong Island, has seen this waste firsthand. In October the sports challenge pitted teams against one another in a competition to remove trash from 13 hard-to-reach coastal areas around the city.</p><p>They find tons of both disposable and reusable masks, said Röling. "You wonder how it ended up there. Was it just thrown on the ground? Or was it in a garbage bag that broke open?"</p><p>Almost 10,000 kilometers away in Antibes on the sunny French Riviera, it's a similar picture. For the past few months, divers and clean-up volunteers working with an ocean clean-up non-profit called Operation Mer Propre have been collecting an increasing number of masks found on land and in the sea.</p><p>"Since the beginning of the lockdown when we started to count, we've reached 800, 900, [and now in total] 1000 masks," said co-founder Joko Peltier. </p><p>According to <a href="https://unctad.org/news/growing-plastic-pollution-wake-covid-19-how-trade-policy-can-help" target="_blank">UN estimates</a>, up to 75% of all coronavirus-related plastic could end up as waste in oceans and landfills.</p>
The Limits of Recycling<p>Yet not all are convinced the recycling of this waste is possible on a global scale. </p><p>"What those citizen groups are doing is really beneficial but once they collect it, it should just go to a landfill or an incinerator. They shouldn't necessarily expect it to get recycled," said Jonathan Krones, an industrial ecologist and visiting assistant professor of environmental studies at Boston College.</p><p>That's because mask recycling programs like Plaxtil are few and far between and most don't have the benefit of a readily adaptable production process. </p><p>Even in countries with solid recycling infrastructure, he says, the system is designed to separate out specific types of waste like bottles or cardboard.</p><p>"I imagine that it would be technically feasible to develop a separation process to filter out masks, but there simply aren't enough of them to make that economical," he said.</p><p>Collection is a big hurdle, he adds. Since each mask only weighs a fraction of a gram and they're scattered on roads or mixed with other trash, it is difficult and costly. </p><p>"You need a lot of raw material of the right quality to make investing in the recycling technology and the recycling system worthwhile," he said.<span></span><br></p>
Hemp, Sugar Cane and Sustainable Alternatives<p>Some projects are instead addressing the material used to make masks.</p><p>French company Geochanvre have created a mask made primarily from hemp, while in Australia, researchers at the Queensland University of Technology are experimenting with a disposable product made from agricultural waste. </p><p>Biodegradable options are exciting alternatives to reduce the fossil fuels needed for the creation of plastic-based masks, said Krones, but they don't absolve the wearer from the responsibility of what happens afterwards. </p><p>Bio-based masks often need their own composing solutions, he explains, because in landfill they can produce high amounts of the greenhouse gas methane when anaerobic bacteria feeds on the organic material. Methane is known to be significantly more potent than carbon dioxide.</p><p>"I think as long as we have in our mind that we want to have disposability, we're going to have to wrestle with a variety of different sorts of environmental tradeoffs," he said, adding that reusable, fabric masks are the best option available to most people.</p><p>Precimask is developing a clear face covering with an optional visor made from hard plastic, designed to be long-lasting.<br></p><p>Air enters either side of the cheeks through a technology normally found in pool filters and car exhaust systems, said company spokeswoman Juliette Chambet.</p><p>"We wanted to make ceramic-based filters that would be washable and cleanable, which would allow them to be reused as many times as desired without having to buy a new consumable or produce waste," she said. </p><p>Ultimately, encouraging mask wearers to think about the entire lifecycle of a mask is key, explains Neveu. </p><p>"We want people who put on the masks to realize that they are also responsible for the waste, he said. "It's not inevitable that this [pandemic] will become an environmental catastrophe.</p><p><em>Reposted with permission from </em><em><a href="https://www.dw.com/en/covid-19-recycling-pollution-trash-pandemic/a-55707817" target="_blank">Deutsche Welle</a>.</em><a href="https://www.ecowatch.com/r/entryeditor/2649032193#/" target="_self"></a></p>
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