Even the FDA Doesn't Know What Chemicals Are in Your Food
We all have secrets, from small ones (the scale isn’t broken, I ate too many cookies!) to bigger ones (yes, we knew for a long time that tobacco kills people).
For more than 50 years, many in the food industry have not had to disclose information to consumers and the Food and Drug Administration (FDA) about the safety of chemicals they put in our food. Additives manufacturers have taken advantage of a dysfunctional regulatory system that allows for minimal or no disclosure, is plagued with conflicts of interest, and provides weak oversight of something as vital to our health as food.
For consumers, it’s bad enough that most of the ingredients listed in packaged food have hard to pronounce names and we do not always know why they are there; we don’t know how much and how many chemicals leach from the packaging into the food; or little is known about the safety of those chemicals because a small percentage are actually tested.
But it gets worse: Companies can add chemicals into our food without ever telling the FDA about their identity, their uses and (wait for it) their safety!
As long as a company designates a chemical as being ‘generally recognized as safe,’ or GRAS in regulatory parlance, according to FDA’s interpretation of the law, it has no responsibility to inform the agency. FDA doesn’t know about the safety of an estimated 1,000 chemicals because they aren’t disclosed.
I’m still a child at heart and what do children do when they are told something is secret? Curiosity is innate. So, we sought to find out what these chemicals are, who is making these safety decisions and why companies choose to forgo FDA’s review process. We identified 56 companies that appear to rely on undisclosed GRAS safety determinations for 275 chemicals. Sixty-two percent of them responded to our inquiries but did not share their safety determination with us; the remaining 38 percent, selling 218 chemicals, never responded us. The great majority of the chemicals were active ingredients in dietary supplements. You can read more about these companies and their reasons to go around the FDA in our Generally Recognized as Secret: Chemicals Added to Food in the United States.
How does this impact me and my family, you may ask? As long as FDA doesn’t know about the safety of thousands of chemicals, it cannot ensure the safety of the food we eat and cannot protect public health. It’s that simple. FDA has tried to figure out how to be informed about the safety of GRAS chemicals for many years; its last attempt was creating a voluntary program whereby companies submit their safety assessment and the agency’s scientists punch holes in their argument. If the company’s argument for safety is strong, the agency sends a “no questions” letter to the company.
If FDA starts raising concerns and the company sees that its argument could fail, a company can withdraw the submission without prejudice and can continue marketing the chemical.
We submitted a Freedom of Information Act (see Appendices) request to the agency for information about 16 chemicals that companies submitted for review but along the evaluation process asked FDA to stop its assessment. In reviewing the FDA records we got, we noticed that the agency’s scientists asked excellent questions and had many concerns about the safety of chemicals. For instance, they were justifiably concerned about epigallocatechn-3-gallate (EGCG) because of its apparent liver, thyroid, testis, spleen and gastrointestinal toxicity in animal tests, and its ability to break down DNA in human cells which may be associated with fetal leukemia.
They were also concerned about GABA, a brain chemical, or theobromine, a stimulant, because by the companies’ own calculations people could be exposed to 5 times more than the safe dose if these chemicals were added to food. In other words, if the exposure is several times higher than the safe dose, the chemical’s use is not safe. Although our report shows the value of FDA’s reviews, the broken system doesn’t stop these potentially unsafe chemicals from reaching our plates, especially for those safety decisions that industry chooses not to disclose to FDA and the public.
How can something be ‘generally recognized’ and not disclosed at the same time? We have heard that these chemicals are “natural” (even though some are highly purified components of the natural source) and people have been eating them for centuries.
We also are told that companies don’t disclose because FDA posts the GRAS notifications it receives in its website and competitors can take advantage of it with little investment. But the lack of disclosure—at least of the studies used to justify a finding of safety—seemingly contradicts the regulations stating that “general recognition of safety through scientific procedures shall ordinarily be based upon published studies…” (21 CFR § 170.30(b)). Or, as an FDA reviewer told a company “[i]n other words, if a panel of experts reviews data that are not publicly available and subsequently renders an opinion regarding safety, even if the experts are well-recognized, the opinion does not meet the general recognition of safety (emphasis added) for GRAS ingredients because the data were not publicly available.”
The GRAS exemption, as it is currently being implemented by the FDA, means that the agency is unable to protect our food and our health. The law places the responsibility on FDA to ensure the safety of chemicals in food. If it doesn’t know what chemicals are in our food or have the documentation demonstrating their safety, it can’t do its job.
We must demand that FDA require that food manufactures inform the agency of safety decisions of chemicals in food. You can help us by taking action here.
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Despite a journey to this moment even more treacherous than expected, Americans now have a fresh opportunity to act, decisively, on climate change.
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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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