FDA Questions Safety of Impossible Burger's Key GMO Ingredient
The U.S. Food and Drug Administration (FDA) told the manufacturer of the meat-like Impossible Burger that the company hadn't demonstrated the safety of the product's key genetically engineered ingredient, according to internal FDA documents. Despite FDA's concerns, Impossible Foods put its GMO-derived burger on the market for public consumption.
GMO Ingredient Gives Product Meat-Like Taste and Red Blood-Like Color
The Impossible Burger is made using a genetically engineered form of a protein called soy leghemoglobin (SLH) or "heme" that is found in the root nodules of soybean plants. Impossible Foods adds a SLH gene to a yeast strain, which is then grown in vats using a fermentation process. The SLH or heme is then isolated from the yeast and added to the Impossible Burger. Heme gives the Impossible Burger its meat-like taste and red blood-like color.
Impossible Foods claims its product "uses about 75 percent less water, generates about 87 percent fewer greenhouse gases and requires around 95 percent less land than conventional ground beef from cows. It's produced without hormones, antibiotics, cholesterol or artificial flavors."
The GMO-derived Impossible Burger is sold in 43 restaurants nationwide, including several burger chains, and Impossible Foods has attracted significant funding from investors such as Bill Gates.
FDA: Arguments "Do Not Establish Safety of SLH for Consumption"
According to documents obtained by ETC Group and Friends of the Earth U.S. through the Freedom of Information Act (FOIA), Impossible Foods submitted an application to seek GRAS (generally recognized as safe) status for SLH from the FDA in 2014. The FDA's 1997 GRAS notification policy allows a manufacturer, like Impossible Foods, to decide for itself, without FDA input, whether or not a product is safe.
But the FDA warned Impossible Foods that SLH would not meet the basic GRAS status. The FOIA-produced documents state that the "FDA believes that the arguments presented, individually and collectively do not establish the safety of SLH for consumption, nor do they point to a general recognition of safety."
According to Michael Hansen, senior scientist at Consumers Union, Impossible Foods claimed that the engineered SLH/heme was identical to the SLH that has been in the food supply but the company had no safety testing data to back that claim.
"You are taking something that has never been in the food supply before and you come to the FDA, say it is GRAS, and you have no safety data, particularly from feeding studies," Hansen said. "Their argument has literally come down to saying this is exactly identical to the heme we've always been eating, but it's not true."
In discussion with FDA, Impossible Foods also admitted that up to a quarter of its heme ingredient was composed of 46 "unexpected" additional proteins, some of which are unidentified and none of which were assessed for safety in the dossier.
"It's only 73 percent pure, the other 27 percent is from proteins from the genetically engineered yeast that produces it, and these have an unknown function," Hansen said.
According to the FOIA documents, Impossible Foods withdrew its GRAS application in November of 2015.
Despite the FDA's warnings, Impossible Foods went ahead and started selling the Impossible Burger in 2016.
"The FDA told Impossible Foods that its burger was not going to meet government safety standards, and the company admitted it didn't know all of its constituents. Yet it sold it anyway to thousands of unwitting consumers. Responsible food companies don't treat customers this way," said Jim Thomas of ETC Group. "Impossible Foods should pull the burgers from the market unless and until safety can be established by the FDA and apologize to those whose safety it may have risked."
David Bronner: "Totally Unethical to Market and Feed an Untested Protein"
A recent New York Times article by Stephanie Strom brought the controversy over the Impossible Burger to light.
In response to the article, Impossible Foods issued a press release attesting to the safety of its product. The company said that "a panel of food safety and allergy experts at three universities unanimously reaffirmed last week that soy leghemoglobin is generally recognized as safe."
Impossible Foods also said it will voluntarily provide the results of a study feeding rats SLH and "additional data to the U.S. Food and Drug Administration."
Yet, Impossible Foods is submitting feeding study results to the FDA after the product has been on the market for a year.
"It's very troubling that Impossible Foods has put this product on the market and, more than one year later, still has not submitted requested safety data, including a rat feeding study, to FDA," Hansen said.
David Bronner, president of Dr. Bronner's Magic Soaps and plant-based foods advocate, had earlier expressed support for the Impossible Burger as a solution to environmental problems caused by industrial meat production. But the recent revelations have changed Bronner's opinion.
"While there is great potential good that the Impossible Burger could do, it's totally unethical to market and feed an untested protein to people and claim that it is identical to what we already eat," he said.
Major Loopholes in FDA Food Safety Regulations
The fact that companies like Impossible Foods can request GRAS status, then withdraw the application when the FDA raises concerns, and yet still put a product on the market shows major loopholes in FDA food safety regulations, according to Hansen.
"The GRAS process is so broken. It's perfectly legal for a company to say whatever compound they want to use is determined to be safe, and then put it in the food supply, and not even tell the FDA."
Another major loophole is that, while FDA conducts reviews of genetically engineered plants and animals, the agency doesn't review products made using genetically engineered microorganisms like the Impossible Burger's heme.
"The FDA doesn't even request safety data," Hansen said.
Hansen believes the GMO heme should be regulated as a color additive because Impossible Foods promotes heme's ability to give the burger a blood-red color like meat. The FDA requires safety assessments of color additives.
"If it affects color and marketability, it meets the definition of a color additive and should be regulated as such," he said.
By Michael Svoboda, Ph.D.
Despite a journey to this moment even more treacherous than expected, Americans now have a fresh opportunity to act, decisively, on climate change.
The authors of the many new books released in just the past few months (or scheduled to be published soon) seem to have anticipated this pivotal moment.
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By Katy Neusteter
The Biden-Harris transition team identified COVID-19, economic recovery, racial equity and climate change as its top priorities. Rivers are the through-line linking all of them. The fact is, healthy rivers can no longer be separated into the "nice-to-have" column of environmental progress. Rivers and streams provide more than 60 percent of our drinking water — and a clear path toward public health, a strong economy, a more just society and greater resilience to the impacts of the climate crisis.
Public Health<img lazy-loadable="true" data-runner-src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yNTUyNDY3MC9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY2MDkxMTkwNn0.pyP14Bg1WvcUvF_xUGgYVu8PS7Lu49Huzc3PXGvATi4/img.jpg?width=980" id="8e577" class="rm-shortcode" data-rm-shortcode-id="1efb3445f5c445e47d5937a72343c012" data-rm-shortcode-name="rebelmouse-image" data-width="3000" data-height="2302" />
Wild and Scenic Merced River, California. Bob Wick / BLM<p>Let's begin with COVID-19. More than <a href="https://www.nytimes.com/interactive/2020/us/coronavirus-us-cases.html?name=styln-coronavirus&region=TOP_BANNER&block=storyline_menu_recirc&action=click&pgtype=LegacyCollection&impression_id=2f508610-2a87-11eb-8622-4f6c038cbd1d&variant=1_Show" target="_blank">16 million Americans</a> have contracted the coronavirus and, tragically,<a href="https://www.nytimes.com/interactive/2020/us/coronavirus-us-cases.html?name=styln-coronavirus&region=TOP_BANNER&block=storyline_menu_recirc&action=click&pgtype=LegacyCollection&impression_id=2f508610-2a87-11eb-8622-4f6c038cbd1d&variant=1_Show" target="_blank"> more than</a> <a href="https://www.nytimes.com/interactive/2020/us/coronavirus-us-cases.html?name=styln-coronavirus&region=TOP_BANNER&block=storyline_menu_recirc&action=click&pgtype=LegacyCollection&impression_id=2f508610-2a87-11eb-8622-4f6c038cbd1d&variant=1_Show" target="_blank">300,000 have died</a> due to the pandemic. While health officials encourage hand-washing to contain the pandemic, at least <a href="https://closethewatergap.org/" target="_blank">2 million Americans</a> are currently living without running water, indoor plumbing or wastewater treatment. Meanwhile, <a href="https://www.theguardian.com/us-news/2020/jun/23/millions-of-americans-cant-afford-water-bills-rise" target="_blank">aging water infrastructure is growing increasingly costly for utilities to maintain</a>. That cost is passed along to consumers. The upshot? <a href="https://research.msu.edu/affordable-water-in-us-reaching-a-crisis/" target="_blank">More than 13 million</a> U.S. households regularly face unaffordable water bills — and, thus, the threat of water shutoffs. Without basic access to clean water, families and entire communities are at a higher risk of <a href="https://www.americanprogress.org/issues/green/news/2020/08/05/488705/bridging-water-access-gap-covid-19-relief/" target="_blank">contracting</a> and spreading COVID-19.</p><p>We have a moral duty to ensure that everyone has access to clean water to help prevent the spread of the coronavirus. Last spring, <a href="https://nymag.com/intelligencer/2020/03/coronavirus-stimulus-bill-explained-bailouts-unemployment-benefits.html" target="_blank">Congress appropriated more than $4 trillion</a> to jumpstart the economy and bring millions of unemployed Americans back to work. Additional federal assistance — desperately needed — will present a historic opportunity to improve our crumbling infrastructure, which has been <a href="https://www.theguardian.com/us-news/2020/jun/23/millions-of-americans-cant-afford-water-bills-rise" target="_blank" rel="noopener noreferrer">grossly underfunded for decades</a>.</p><p>A report by my organization, American Rivers, suggests that <a href="https://s3.amazonaws.com/american-rivers-website/wp-content/uploads/2020/07/09223525/ECONOMIC-ENGINES-Report-2020.pdf" target="_blank" rel="noopener noreferrer">Congress must invest at least $50 billion</a> "to address the urgent water infrastructure needs associated with COVID-19," including the rising cost of water. This initial boost would allow for the replacement and maintenance of sewers, stormwater infrastructure and water supply facilities.</p>
Economic Recovery<p>Investing in water infrastructure and healthy rivers also creates jobs. Consider, for example, that <a href="https://tinyurl.com/y9p6sgnk" target="_blank">every $1 million spent on water infrastructure in the United States generates more than 15 jobs</a> throughout the economy, according to a report by the Value of Water Campaign. Similarly, <a href="https://tinyurl.com/yyvd2ksp" target="_blank">every "$1 million invested in forest and watershed restoration contracting will generate between 15.7 and 23.8 jobs,</a> depending on the work type," states a working paper released by the Ecosystem Workforce Program, University of Oregon. Healthy rivers also spur tourism and recreation, which many communities rely on for their livelihoods. According to the findings by the Outdoor Industry Association, which have been shared in our report, "Americans participating in watersports and fishing spend over <a href="https://s3.amazonaws.com/american-rivers-website/wp-content/uploads/2020/06/30222425/Exec-summary-ECONOMIC-ENGINES-Report-June-30-2020.pdf" target="_blank">$174 billion</a> on gear and trip related expenses. And, the outdoor watersports and fishing economy supports over <a href="https://s3.amazonaws.com/american-rivers-website/wp-content/uploads/2020/06/30222425/Exec-summary-ECONOMIC-ENGINES-Report-June-30-2020.pdf" target="_blank">1.5 million jobs nationwide</a>."</p><p>After the 2008 financial crisis, Congress invested in infrastructure to put Americans back to work. The American Recovery and Reinvestment Act <a href="https://thehill.com/blogs/congress-blog/economy-a-budget/25941-clean-water-green-infrastructure-get-major-boost" target="_blank">of 2009 (ARRA) allocated $6 billion</a> for clean water and drinking water infrastructure to decrease unemployment and boost the economy. More specifically, <a href="https://www.conservationnw.org/news-updates/us-reps-push-for-millions-of-restoration-and-resilience-jobs/" target="_blank" rel="noopener noreferrer">an analysis of ARRA</a> "showed conservation investments generated 15 to 33 jobs per million dollars," and more than doubled the rate of return, according to a letter written in May 2020 by 79 members of Congress, seeking greater funding for restoration and resilience jobs.</p><p>Today, when considering how to create work for the <a href="https://www.bls.gov/news.release/pdf/empsit.pdf" target="_blank" rel="noopener noreferrer">10.7 million</a> people who are currently unemployed, Congress should review previous stimulus investments and build on their successes by embracing major investments in water infrastructure and watershed restoration.</p>
Racial Justice<p>American Rivers also recommends that Congress dedicate <a href="https://s3.amazonaws.com/american-rivers-website/wp-content/uploads/2020/07/09223525/ECONOMIC-ENGINES-Report-2020.pdf" target="_blank" rel="noopener noreferrer">$500 billion for rivers and clean water over the next 10 years</a> — not just for the benefit of our environment and economy, but also to begin to address the United States' history of deeply entrenched racial injustice.</p><p>The <a href="https://www.epa.gov/npdes/sanitary-sewer-overflows-ssos" target="_blank" rel="noopener noreferrer">23,000-75,000 sewer overflows</a> that occur each year release up to <a href="https://www.americanrivers.org/2020/05/fighting-for-rivers-means-fighting-for-justice/#:~:text=There%20are%20also%2023%2C000%20to%2075%2C000%20sanitary%20sewer,to%20do%20with%20the%20mission%20of%20American%20Rivers." target="_blank" rel="noopener noreferrer">10 billion gallons of toxic sewage</a> <em>every day</em> into rivers and streams. This disproportionately impacts communities of color, because, for generations, Black, Indigenous, Latinx and other people of color have been <a href="https://www.scientificamerican.com/article/flooding-disproportionately-harms-black-neighborhoods/" target="_blank" rel="noopener noreferrer">relegated</a> to live in flood-prone areas and in neighborhoods that have been intentionally burdened with a lack of development that degrades people's health and quality of life. In some communities of color, incessant flooding due to stormwater surges or <a href="https://www.ajc.com/opinion/opinion-partnering-to-better-manage-our-water/7WQ6SEAQP5E4LGQCEYY5DO334Y/" target="_blank" rel="noopener noreferrer">combined sewer overflows</a> has gone unmitigated for decades.</p><p>We have historically treated people as separate from rivers and water. We can't do that anymore. Every voice — particularly those of people most directly impacted — must have a loudspeaker and be included in decision-making at the highest levels.</p><p>Accordingly, the new administration must diligently invest in projects at the community level that will improve lives in our country's most marginalized communities. We also must go further to ensure that local leaders have a seat at the decision-making table. To this end, the Biden-Harris administration should restore <a href="https://www.epa.gov/cwa-401#:~:text=Section%20401%20Certification%20The%20Clean%20Water%20Act%20%28CWA%29,the%20United%20States.%20Learn%20more%20about%20401%20certification." target="_blank">Section 401 of the Clean Water Act</a>, which was undermined by the <a href="https://earthjustice.org/news/press/2020/tribes-and-environmental-groups-sue-trump-administration-to-preserve-clean-water-protections#:~:text=Under%20Section%20401%20of%20the%20Clean%20Water%20Act%2C,seeks%20to%20undermine%20that%20authority%20in%20several%20ways%3A" target="_blank">Trump administration's 2020 regulatory changes</a>. This provision gives states and tribes the authority to decide whether major development projects, such as hydropower and oil and gas projects, move forward.</p>
Climate Resilience<p>Of course, the menacing shadow looming over it all? Climate change. <a href="https://media.ifrc.org/ifrc/wp-content/uploads/2020/11/IFRC_wdr2020/IFRC_WDR_ExecutiveSummary_EN_Web.pdf" target="_blank">More than 100 climate-related catastrophes</a> have pummeled the Earth since the pandemic was declared last spring, including the blitzkrieg of megafires, superstorms and heat waves witnessed during the summer of 2020, directly impacting the lives of more than <a href="https://media.ifrc.org/ifrc/wp-content/uploads/2020/11/IFRC_wdr2020/IFRC_WDR_ExecutiveSummary_EN_Web.pdf" target="_blank">50 million people globally</a>.</p><p>Water and climate scientist Brad Udall often says, "<a href="https://www.youtube.com/watch?v=xQhpj5G0dME" target="_blank">Climate change is water change</a>." In other words, the most obvious and dire impacts of climate change are evidenced in profound changes to our rivers and water resources. You've likely seen it where you live: Floods are more damaging and frequent. Droughts are deeper and longer. Uncertainty is destabilizing industry and lives.</p><p>By galvanizing action for healthy rivers and managing our water resources more effectively, we can insure future generations against the consequences of climate change. First, we must safeguard rivers that are still healthy and free-flowing. Second, we must protect land and property against the ravages of flooding. And finally, we must promote policies and practical solutions that take the science of climate disruption into account when planning for increased flooding, water shortage and habitat disruption.</p><p>Imagine all that rivers do for us. Most of our towns and cities have a river running through them or flowing nearby. Rivers provide clean drinking water, irrigate crops that provide our food, power our homes and businesses, provide wildlife habitat, and are the lifeblood of the places where we enjoy and explore nature, and where we play and nourish our spirits. Healthy watersheds help <a href="https://news.un.org/en/story/2020/03/1059952" target="_blank" rel="noopener noreferrer">mitigate</a> climate change, absorbing and reducing the amount of carbon in the atmosphere. Healthy rivers and floodplains help communities adapt and build resilience in the face of climate change by improving flood protection and providing water supply and quality benefits. Rivers are the cornerstones of healthy, strong communities.</p><p>The more than <a href="https://archive.epa.gov/water/archive/web/html/index-17.html" target="_blank" rel="noopener noreferrer">3 million miles</a> of rivers and streams running across our country are a source of great strength and opportunity. When we invest in healthy rivers and clean water, we can improve our lives. When we invest in rivers, we create jobs and strengthen our economy. When we invest in rivers, we invest in our shared future.</p>
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