Newly Disclosed Documents Reveal Livestock Antibiotic Use by FDA Despite 'High Risk' to Humans
The U.S. Food and Drug Administration (FDA) quietly allowed 30 potentially harmful antibiotics—including 18 rated as "high risk"—to remain on the market as additives in farm animal feed and water, despite an internal review that raised significant red flags, according to agency records obtained by the Natural Resources Defense Council (NRDC).
The data show the use of these drugs in livestock likely exposes humans to antibiotic resistant bacteria through the food supply. The FDA’s scientific reviews of these antibiotics occurred between 2001 and 2010, yet the drugs remain approved and, in many cases, on the market for use in industrial animal agriculture operations.
"The evidence is clear—drugmakers never proved safety," said Carmen Cordova, NRDC microbiologist and lead author of the new analysis. "And FDA continues to knowingly allow the use of drugs in animal feed that likely pose a ‘high risk’ to human health."
"That’s a breach of their responsibility and the public trust,” continued Cordova. “This discovery is disturbing but not surprising given the FDA’s poor track record on dealing with this issue. It’s just more overwhelming evidence that FDA—in the face of a mounting antibiotic resistance health crisis—is turning a blind eye to industry’s misuse of these miracle drugs.”
The FDA’s documents, captured in the analysis Playing Chicken with Antibiotics, show safety reviews of various drugs in the penicillin and tetracycline drug classes—antibiotics considered important to human medicine, which together comprise nearly half of all antibiotics used in animal agriculture in the U.S. The documents were acquired through a Freedom of Information Act (FOIA) lawsuit filed by NRDC and reveal:
- None of the 30 antibiotics would likely be approved as new additives for livestock use if submitted under current FDA guidelines, because drugmakers have not submitted sufficient information to establish their safety.
- 18 of the 30 antibiotic feed additives reviewed (nearly two out of three) were deemed to pose a “high risk” of exposing humans to antibiotic resistant bacteria through the food supply and of adversely affecting human health.
- Drug manufacturers never submitted sufficient information for the remaining 12 products to establish safety, meaning there is no proof of their safety for humans when used in animal feed and the products could not be approved today.
- 29 of the reviewed additives fail to satisfy the FDA’s first iteration of safety requirements from 1973.
The significance of these findings extends far beyond the 30 antibiotic feed additives reviewed. A large body of scientific work on bacterial cross- and co-resistance has established that the misuse of one antibiotic can actually lead to bacterial resistance to other antibiotics. Consequently, the 30 penicillin- and tetracycline-based animal feed additives in this analysis could reduce the effectiveness of a range of other medically important antibiotics that are solely used to treat people.
The FDA first recognized the risks from the use of antibiotics in animal feed in 1977 when it proposed to withdraw approvals for animal feed containing penicillin and most tetracyclines. NRDC won a lawsuit against the FDA for failing to follow through and address the threat posed by the misuse of penicillin and tetracyclines in the livestock industry. Instead of acting on their own scientific findings and heeding the court ruling, the FDA appealed, and a decision is now pending in the U.S. Court of Appeals for the Second Circuit, in New York.
The World Health Organization lists penicillins as critically important for human medicine and tetracyclines as highly important. Penicillins are commonly used to treat bacterial meningitis and syphilis in humans. Tetracyclines are commonly prescribed for eye infections, Lyme disease, gonorrhea and chlamydia. The FDA also recognizes both as highly important. Unfortunately, both penicillins and tetracyclines are no longer effective for treating some infections because of high levels of resistance in bacteria, brought on, in part, due to their widespread use in industrial farms. Increasing resistance to these drugs decreases the options available for human treatment.
The FDA’s failure to act on its own findings on the 30 reviewed antibiotic feed additives is unfortunately consistent with the agency’s decades-long history of failure to effectively deal with this issue. Today, 70 percent of all medically important antibiotics sold in the U.S. are sold for use in livestock production—not on humans. The FDA is responsible for regulating the use of antibiotics in animal agriculture, but has done little to address the growing misuse and overuse of these drugs by the industry since first recognizing the health risks nearly four decades ago.
In 1977, the agency itself concluded that feeding animals low doses of certain antibiotics used in human medicine, namely penicillin and tetracyclines, could promote antibiotic-resistant bacteria capable of infecting people, and posed a risk to human health. Since then, the science on the human health risks of these practices has only gotten stronger but drugs sales for livestock use have continued to trend upwards nearly unchecked.
Despite the FDA’s own scientific findings—and two federal court orders in 2012 resulting from NRDC litigation that require the FDA to act on the misuse of antibiotics on animals that are not sick—the FDA has never followed through. Instead, they've issued Voluntary Guidance 213: loophole-laden recommendations that offer no meaningful improvement over its lack of action over the last 36 years. Meanwhile, the FDA has appealed the court orders and a decision is pending the Second Circuit Court of Appeals.
For decades, leading health groups, medical doctors and other scientists from the American Academy of Pediatrics to Infectious Disease Society of America have sounded the alarm, stating that “overuse and misuse of important antibiotics in food animals must end, in order to protect human health.” These groups and others, including the Centers for Disease Control and the World Health Organization, warn that the overuse and misuse of antibiotics in animals that don’t need them can create dangerous drug-resistant “superbugs” capable of infecting humans.
Antibiotic resistance in humans has reached a crisis point, threatening the efficacy of many life-saving drugs. The Center for Disease Control recently confirmed the link between antibiotic use on industrial farms and the rise of antibiotic resistance in Antibiotic Resistance Threats in the U.S., 2013, saying there is “strong scientific evidence of a link between antibiotic use in food animals and antibiotic resistance in humans,” and warns of “potentially catastrophic consequences” if resistance is not slowed. The Center for Disease Control also stated that “up to half of antibiotic use in humans and much of antibiotic use in animals is unnecessary and inappropriate and makes everyone less safe.”
This was originally posted to NRDC’s Media Center.
Visit EcoWatch’s FOOD page for more related news on this topic.
By Kenny Stancil
An expert panel of top international and environmental lawyers have begun working this month on a legal definition of "ecocide" with the goal of making mass ecological damage an enforceable international crime on par with war crimes, crimes against humanity, and genocide.
- Are the Amazon Fires a Crime Against Humanity? - EcoWatch ›
- 'Her Work Will Live On': Climate Movement Mourns Loss of Ecocide ... ›
EcoWatch Daily Newsletter
After ongoing pressure from environmental groups and Indigenous communities, Bank of America has said it will not finance any oil and gas exploration in the Arctic, making it the last major U.S. financial institution to do so.
- Bank of America Sponsors Polluted Air and Chicago Marathon ... ›
- Youth Activists Hit the Streets to Protest Bank of America - EcoWatch ›
- Environmental and Economic Justice Communities Target Bank of ... ›
By Astrid Caldas
As we reach the official end of hurricane season, 2020 will be one for the record books. Looking back at these long, surprising, sometimes downright crazy past six months (seven if you count when the first named storms actually started forming), there are many noteworthy statistics and patterns that drive home the significance of this hurricane season, and the ways climate change may have contributed to it.
A summary infographic showing hurricane season probability and numbers of named storms predicted from NOAA's 2020 Atlantic Hurricane Season Outlook. NOAA
The updated 2020 Atlantic hurricane season probability and numbers of named storms. NOAA
- Tropical Storm Theta Is Record-Breaking 29th Storm of 2020 ... ›
- Hurricane Delta Breaks Record for Earliest 25th Named Storm ... ›
By Dana Drugmand
An unprecedented climate lawsuit brought by six Portuguese youths is to be fast-tracked at Europe's highest court, it was announced today.
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>
Will concern over the climate crisis stop people from having children?
- 'BirthStrike' Movement Encourages People to Stop Having Children ... ›
- Should You Have Kids Despite Climate Change? - EcoWatch ›