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Will More GMO Foods Be Approved Under FDA’s New Leadership?

Insights + Opinion

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.


As the news filtered out, stocks went up and down, consumer advocacy groups looked back on Gottlieb's legacy and commentators worried about the future of the agency.

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.

Ocean pout from Newfoundland, Canada

Derek Keats, CC BY-SA

Gottlieb's FDA and Regulation of GE Food

Also in 2016, Congress made the U.S. Department of Agriculture the leading player in the labeling of genetically engineered food. The USDA issued final regulations on this topic in late 2018.

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.

But we should not expect FDA to challenge the prevailing wisdom among regulatory agencies when it comes to genetically modified food.

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.

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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Ola Elvestrun, Norway's environment minister, announced Thursday that it is freezing its contributions to the Amazon Fund, and will no longer be transferring €300 million ($33.2 million) to Brazil. In a press release, the Norwegian embassy in Brazil stated:

Given the present circumstances, Norway does not have either the legal or the technical basis for making its annual contribution to the Amazon Fund.

Brazilian President Jair Bolsonaro reacted with sarcasm to Norway's decision, which had been widely expected. After an official event, he commented: "Isn't Norway the country that kills whales at the North Pole? Doesn't it also produce oil? It has no basis for telling us what to do. It should give the money to Angela Merkel [the German Chancellor] to reforest Germany."

According to its website, the Amazon Fund is a "REDD+ mechanism created to raise donations for non-reimbursable investments in efforts to prevent, monitor and combat deforestation, as well as to promote the preservation and sustainable use in the Brazilian Amazon." The bulk of funding comes from Norway and Germany.

The annual transfer of funds from developed world donors to the Amazon Fund depends on a report from the Fund's technical committee. This committee meets after the National Institute of Space Research, which gathers official Amazon deforestation data, publishes its annual report with the definitive figures for deforestation in the previous year.

But this year the Amazon Fund's technical committee, along with its steering committee, COFA, were abolished by the Bolsonaro government on 11 April as part of a sweeping move to dissolve some 600 bodies, most of which had NGO involvement. The Bolsonaro government views NGO work in Brazil as a conspiracy to undermine Brazil's sovereignty.

The Brazilian government then demanded far-reaching changes in the way the fund is managed, as documented in a previous article. As a result, the Amazon Fund's technical committee has been unable to meet; Norway says it therefore cannot continue making donations without a favorable report from the committee.

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An Uncertain Future

The Amazon Fund was announced during the 2007 United Nations Climate Change Conference in Bali, during a period when environmentalists were alarmed at the rocketing rate of deforestation in the Brazilian Amazon. It was created as a way of encouraging Brazil to continue bringing down the rate of forest conversion to pastures and croplands.

Government agencies, such as IBAMA, Brazil's environmental agency, and NGOs shared Amazon Fund donations. IBAMA used the money primarily to enforce deforestation laws, while the NGOs oversaw projects to support sustainable communities and livelihoods in the Amazon.

There has been some controversy as to whether the Fund has actually achieved its goals: in the three years before the deal, the rate of deforestation fell dramatically but, after money from the Fund started pouring into the Amazon, the rate remained fairly stationary until 2014, when it began to rise once again. But, in general, the international donors have been pleased with the Fund's performance, and until the Bolsonaro government came to office, the program was expected to continue indefinitely.

Norway has been the main donor (94 percent) to the Amazon Fund, followed by Germany (5 percent), and Brazil's state-owned oil company, Petrobrás (1 percent). Over the past 11 years, the Norwegians have made, by far, the biggest contribution: R$3.2 billion ($855 million) out of the total of R$3.4 billion ($903 million).

Up till now the Fund has approved 103 projects, with the dispersal of R$1.8 billion ($478 million). These projects will not be affected by Norway's funding freeze because the donors have already provided the funding and the Brazilian Development Bank is contractually obliged to disburse the money until the end of the projects. But there are another 54 projects, currently being analyzed, whose future is far less secure.

One of the projects left stranded by the dissolution of the Fund's committees is Projeto Frutificar, which should be a three-year project, with a budget of R$29 million ($7.3 million), for the production of açai and cacao by 1,000 small-scale farmers in the states of Amapá and Pará. The project was drawn up by the Brazilian NGO IPAM (Institute of Environmental research in Amazonia).

Paulo Moutinho, an IPAM researcher, told Globo newspaper: "Our program was ready to go when the [Brazilian] government asked for changes in the Fund. It's now stuck in the BNDES. Without funding from Norway, we don't know what will happen to it."

Norway is not the only European nation to be reconsidering the way it funds environmental projects in Brazil. Germany has many environmental projects in the Latin American country, apart from its small contribution to the Amazon Fund, and is deeply concerned about the way the rate of deforestation has been soaring this year.

The German environment ministry told Mongabay that its minister, Svenja Schulze, had decided to put financial support for forest and biodiversity projects in Brazil on hold, with €35 million ($39 million) for various projects now frozen.

The ministry explained why: "The Brazilian government's policy in the Amazon raises doubts whether a consistent reduction in deforestation rates is still being pursued. Only when clarity is restored, can project collaboration be continued."

Bauxite mines in Paragominas, Brazil. The Bolsonaro administration is urging new laws that would allow large-scale mining within Brazil's indigenous reserves.

Hydro / Halvor Molland / Flickr

Alternative Amazon Funding

Although there will certainly be disruption in the short-term as a result of the paralysis in the Amazon Fund, the governors of Brazil's Amazon states, which rely on international funding for their environmental projects, are already scrambling to create alternative channels.

In a press release issued yesterday Helder Barbalho, the governor of Pará, the state with the highest number of projects financed by the Fund, said that he will do all he can to maintain and increase his state partnership with Norway.

Barbalho had announced earlier that his state would be receiving €12.5 million ($11.1 million) to run deforestation monitoring centers in five regions of Pará. Barbalho said: "The state governments' monitoring systems are recording a high level of deforestation in Pará, as in the other Amazon states. The money will be made available to those who want to help [the Pará government reduce deforestation] without this being seen as international intervention."

Amazonas state has funding partnerships with Germany and is negotiating deals with France. "I am talking with countries, mainly European, that are interested in investing in projects in the Amazon," said Amazonas governor Wilson Miranda Lima. "It is important to look at Amazônia, not only from the point of view of conservation, but also — and this is even more important — from the point of view of its citizens. It's impossible to preserve Amazônia if its inhabitants are poor."

Signing of the EU-Mercusor Latin American trading agreement earlier this year. The pact still needs to be ratified.

Council of Hemispheric Affairs

Looming International Difficulties

The Bolsonaro government's perceived reluctance to take effective measures to curb deforestation may in the longer-term lead to a far more serious problem than the paralysis of the Amazon Fund.

In June, the European Union and Mercosur, the South American trade bloc, reached an agreement to create the largest trading bloc in the world. If all goes ahead as planned, the pact would account for a quarter of the world's economy, involving 780 million people, and remove import tariffs on 90 percent of the goods traded between the two blocs. The Brazilian government has predicted that the deal will lead to an increase of almost $100 billion in Brazilian exports, particularly agricultural products, by 2035.

But the huge surge this year in Amazon deforestation is leading some European countries to think twice about ratifying the deal. In an interview with Mongabay, the German environment ministry made it very clear that Germany is very worried about events in the Amazon: "We are deeply concerned given the pace of destruction in Brazil … The Amazon Forest is vital for the atmospheric circulation and considered as one of the tipping points of the climate system."

The ministry stated that, for the trade deal to go ahead, Brazil must carry out its commitment under the Paris Climate agreement to reduce its greenhouse gas emissions by 43 percent below the 2005 level by 2030. The German environment ministry said: If the trade deal is to go ahead, "It is necessary that Brazil is effectively implementing its climate change objectives adopted under the [Paris] Agreement. It is precisely this commitment that is expressly confirmed in the text of the EU-Mercosur Free Trade Agreement."

Blairo Maggi, Brazil agriculture minister under the Temer administration, and a major shareholder in Amaggi, the largest Brazilian-owned commodities trading company, has said very little in public since Bolsonaro came to power; he's been "in a voluntary retreat," as he puts it. But Maggi is so concerned about the damage Bolsonaro's off the cuff remarks and policies are doing to international relationships he decided to speak out earlier this week.

Former Brazil Agriculture Minister Blairo Maggi, who has broken a self-imposed silence to criticize the Bolsonaro government, saying that its rhetoric and policies could threaten Brazil's international commodities trade.

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Maggi, a ruralista who strongly supports agribusiness, told the newspaper, Valor Econômico, that, even if the European Union doesn't get to the point of tearing up a deal that has taken 20 years to negotiate, there could be long delays. "These environmental confusions could create a situation in which the EU says that Brazil isn't sticking to the rules." Maggi speculated. "France doesn't want the deal and perhaps it is taking advantage of the situation to tear it up. Or the deal could take much longer to ratify — three, five years."

Such a delay could have severe repercussions for Brazil's struggling economy which relies heavily on its commodities trade with the EU. Analysists say that Bolsonaro's fears over such an outcome could be one reason for his recently announced October meeting with Chinese President Xi Jinping, another key trading partner.

Maggi is worried about another, even more alarming, potential consequence of Bolsonaro's failure to stem illegal deforestation — Brazil could be hit by a boycott by its foreign customers. "I don't buy this idea that the world needs Brazil … We are only a player and, worse still, replaceable." Maggi warns, "As an exporter, I'm telling you: things are getting very difficult. Brazil has been saying for years that it is possible to produce and preserve, but with this [Bolsonaro administration] rhetoric, we are going back to square one … We could find markets closed to us."

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