Superbug Suit: Court Slams FDA on Antibiotics in Animal Feed
Last night, for a second time in three months, a federal court ordered the Food and Drug Administration (FDA) to take action to protect public health from the overuse of antibiotics in animal feed by instructing FDA to reconsider two citizen petitions which urge the agency to revoke approvals for all nontherapeutic uses of antibiotics in livestock production. For years, scientists, health care organizations and government agencies have warned that the widespread use of antibiotics to hasten animal growth and compensate for unsanitary and over-crowded feedlots results in diminishing effectiveness of these essential medicines to treat infections in people.
“The court’s order pushes the agency one step closer to meaningful action to curb the dangerous overuse of antibiotics in animal feed,” said Avinash Kar, Natural Resources Defense Council (NRDC) health attorney. “The court calls out FDA’s protracted foot-dragging on the problem of antibiotic resistance and requires the agency do its job to protect our food, our health and our families.”
FDA denied the citizen group petitions late last year, in favor of an unenforceable guidance document that recommends the industry voluntarily discontinue this widespread drug use. The court ruled that FDA’s denial of the citizen petitions, which were filed seven and thirteen years ago, violated the law because the agency failed to address the substantial scientific evidence presented by the petitions that the use of penicillin, tetracycline and five additional drug classes in livestock production poses risks to human health.
The decision resolves the second claim in a lawsuit filed by the Natural Resources Defense Council, Center for Science in the Public Interest (CSPI), Food Animal Concerns Trust (FACT), Public Citizen and Union of Concerned Scientists (UCS) last year. The victory comes just two months after a court order that compels FDA to withdraw approval for most nontherapeutic uses of penicillin and tetracyclines in animal feed, unless the industry can prove in public hearings that those drug uses are safe.
The court decision noted, “For over thirty years, the Agency has been confronted with evidence of the human health risks associated with the widespread subtherapeutic use of antibiotics in food-producing animals, and, despite a statutory mandate to ensure the safety of animal drugs, the Agency has done shockingly little to address these risks.” The FDA insisted that withdrawal proceedings would be too time consuming, but the court called that position “both ironic and arbitrary,” saying “had the Agency addressed the Petitions in a timely fashion, withdrawal proceedings could have been commenced and completed by now.”
“As the court points out, FDA has recognized but stopped just short of making formal findings that the nontherapeutic use of antibiotics in livestock production poses a risk to human health,” said NRDC attorney Jen Sorenson. “By forcing the agency to grapple with the science, the court’s order paves the way for a ban on these dangerous drug uses.”
The June 4 ruling also challenges FDA’s unenforceable “voluntary guidance” policy for antibiotic use, which it adopted shortly after the ruling in March. That policy was criticized by NRDC and other public interest organizations for being ineffective. The court held that FDA had “forsaken” its statutory obligation to ensure the safety of all marketed drugs “in the name of a proposed voluntary program.”
“This is a great victory for the public health” said Margaret Mellon, senior scientist of Union of Concerned Scientists. “The court has seen through the FDA’s excuses and is ordering the agency to move expeditiously on critical issues that have dragged on for far too long.”
According to the Union of Concerned Scientists, approximately 70 percent of all antibiotics used in the U.S. are given to healthy farm animals at low doses to promote faster growth and compensate for unsanitary living conditions—a practice that has increased over the past 60 years despite evidence that it breeds antibiotic-resistant bacteria dangerous to humans. The antibiotics, mixed into feed or water for pigs, cows, chicken and turkeys, are used at levels too low to treat disease, leaving surviving bacteria stronger and resistant to medical treatment.
The American Academy of Pediatrics, the American Medical Association, the Infectious Diseases Society of America, the Centers for Disease Control and Prevention, the Institute of Medicine of the National Academy of Sciences, the United States Department of Agriculture (USDA), the World Health Organization and many other groups have identified the routine use of low-dose antibiotics for livestock growth promotion as a significant contributor to the rapid proliferation of antibiotic-resistant bacteria in both animals and humans.
"It's a powerful statement for a federal judge to tell a federal agency that it has been 'arbitrary and capricious' in denying regulatory petitions from consumer groups," said Center for Science in the Public Interest executive director Michael F. Jacobson. "We hope that this decision, combined with Judge Katz's earlier decision, will speed an end to the inappropriate use of medically important antibiotics in animal agriculture."
“For years the FDA has avoided taking action by simply refusing to look at the evidence,” said Steven Roach, FACT’s Public Health Program director. “With this order, the FDA will be forced to look at the evidence and withdraw drugs that are putting public health at risk.”
For more information on this lawsuit and antibiotics in animal feed, see:
- Avinash Kar’s blog on the decision: Court to FDA: Follow the Law on Curbing Overuse of Antibiotics in Livestock
EcoWatch Daily Newsletter
World Environment Day: A Time to Consider the Planet We’ll Return To, and Decide How to Care for It Going Forward
It's a different kind of World Environment Day this year. In prior years, it might have been enough to plant a tree, spend some extra time in the garden, or teach kids the importance of recycling. This year we have heavier tasks at hand. It's been months since we've been able to spend sufficient time outside, and as we lustfully watch the beauty of a new spring through our kitchen's glass windows, we have to decide how we'll interact with the natural world on our release, and how we can prevent, or be equipped to handle, future threats against our wellbeing.
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DAN medical experts explained the difference between normal lungs, on the left, and "very serious lungs caused by COVID-19," on the right. Matias Nochetto / Divers Alert Network (DAN)
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President Trump's claim that the U.S. has the cleanest air and water in the world has been widely refuted by statistics showing harmful levels of pollution. Now, a new biannual ranking released by researchers at Yale and Columbia finds that the U.S. is nowhere near the top in environmental performance, according to The Guardian.
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By Lindsey Schneider, Joshua Sbicca and Stephanie Malin
The SARS-CoV-2 virus is novel, but pandemic threats to indigenous peoples are anything but new. Diseases like measles, smallpox and the Spanish flu have decimated Native American communities ever since the arrival of the first European colonizers.
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History Reverberates on Native Lands<p>Native communities in North America have been disrupted and displaced for centuries. Many face long-standing food and water <a href="http://www.nativepartnership.org/site/DocServer/2017-PWNA-NPRA-Food-Insecurity-Project-Grow.pdf?docID=7106" target="_blank">inequities</a> that are further complicated by this pandemic.</p><p>On the Navajo reservation, which covers more than 27,000 square miles in Arizona, Utah and New Mexico, 76% of households already <a href="https://www.researchgate.net/publication/235390130_High_levels_of_household_food_insecurity_on_the_Navajo_Nation" target="_blank">have trouble affording enough healthy food</a>, and the nearest grocery store is often hours away. COVID-related restrictions have further curtailed access to food supplies.</p><p>Clean water for basic sanitary measures like hand-washing is also scarce. Native Americans are <a href="http://uswateralliance.org/sites/uswateralliance.org/files/Closing%20the%20Water%20Access%20Gap%20in%20the%20United%20States_DIGITAL.pdf" target="_blank">19 times more likely</a> to lack indoor plumbing than whites in the U.S. Nearly one-third of Navajo households <a href="https://www.nbcnews.com/news/us-news/coronavirus-hits-indian-country-hard-exposing-infrastructure-disparities-n1186976" target="_blank">lack access to running water</a>.</p><p>Many <a href="https://www.cdc.gov/mmwr/volumes/69/wr/mm6915e3.htm" target="_blank">health issues</a> that can increase COVID-19 mortality rates occur at high levels among Native Americans. These <a href="http://www.ncai.org/news/articles/2020/03/18/the-national-congress-of-american-indians-calls-for-more-attention-to-covid-19-impacts-to-indian-country" target="_blank">underlying</a> and <a href="https://doi.org/10.1016/S0140-6736(20)30893-X" target="_blank">preexisting</a> conditions – things like hypertension, diabetes, obesity and cardiovascular disease – are <a href="https://www.cdc.gov/mmwr/volumes/69/wr/mm6913e2.htm" target="_blank">linked to diet</a> and stem from <a href="https://www.oupress.com/books/15107980/indigenous-food-sovereignty-in-the-united-sta" target="_blank">disruption and replacement</a> of Indigenous food systems.</p>
High Exposure Rates<p>These factors have clear health impacts. On the Navajo reservation, for instance, through May 27, 2020, <a href="https://www.navajo-nsn.gov/News%20Releases/OPVP/2020/May/FOR%20IMMEDIATE%20RELEASE%20-%201620%20recoveries_102%20new%20cases%20of%20COVID-19_and%20one%20more%20death%20reported.pdf" target="_blank">4,944 people</a> out of a population of 173,000 had tested positive for COVID-19, and 159 had died.</p><p>This infection rate per capita exceeds those in hot spots such as <a href="https://www.forbes.com/sites/alexandrasternlicht/2020/05/19/navajo-nation-has-most-coronavirus-infections-per-capita-in-us-beating-new-york-new-jersey/#11a4fac08b10" target="_blank">New York and New Jersey</a>. Importantly, however, it may also reflect a much <a href="https://www.sltrib.com/news/2020/04/19/navajo-nation-has-higher/" target="_blank">more proactive approach to testing</a> on reservations than in many other jurisdictions.</p><p>The fact that elderly people are especially vulnerable to COVID-19 could worsen the pandemic's effects in Indian Country. Elders are the <a href="https://ais.washington.edu/research/publications/spirits-our-whaling-ancestors" target="_blank">keepers of traditional knowledge, tribal languages and culture</a> – legacies whose loss already threatens the persistence of indigenous communities.</p><p>Elders also play key roles in preserving traditional plant and medicine knowledge. In the absence of COVID-19 interventions from Western medicine, many elders have been called on to perform healing practices, which increases their exposure risk.</p>
Little Help From Federal and State Governments<p>Many tribal members rely on the federal government's <a href="https://www.ihs.gov/" target="_blank">Indian Health Service</a> for health care. But <a href="https://theconversation.com/tribal-leaders-face-great-need-and-dont-have-enough-resources-to-respond-to-the-coronavirus-pandemic-134372" target="_blank">lack of capacity</a> at the agency has hampered its response. Budget shortfalls, <a href="https://indiancountrytoday.com/news/report-grossly-inaccurate-data-used-to-divvy-up-relief-funds-for-tribes-9qkkHmeXj0uhRC42mXYqCA" target="_blank">inaccurate data</a>, the challenges of providing <a href="https://indiancountrytoday.com/news/coronavirus-risk-is-compounded-by-the-rural-DC-rMTUzzE6WDGee8jbENQ" target="_blank">rural health care</a> and ongoing personnel shortages in IHS clinics are compounded by staff being <a href="https://navajotimes.com/reznews/dikos-ntsaaigii-doodaa-nation-musters-defense-against-covid-19/" target="_blank">pulled away</a> to fight the virus in large cities.</p><p>And while many states have raised frustrations with the Trump administration's unwillingness to distribute protective supplies from the <a href="https://www.vox.com/recode/2020/4/3/21206170/us-emergency-stockpile-jared-kushner-almost-empty-coronavirus-medical-supplies-ventilators" target="_blank">dwindling national stockpile</a>, IHS and tribal health care authorities <a href="https://www.azpm.org/p/home-articles-news/2020/3/17/167874-bill-calls-for-more-tribal-community-access-to-federal-stockpile-of-medical-supplies/" target="_blank">never had access</a> to the stockpile at all.</p><p>Although the federal government has begun <a href="https://www.hhs.gov/about/news/2020/05/22/hhs-announces-500-million-distribution-to-tribal-hospitals-clinics-and-urban-health-centers.html" target="_blank">distributing relief funds</a> to IHS agencies, there have been serious problems with the accompanying supplies. The Navajo Nation has received <a href="https://www.indianz.com/News/2020/05/22/propublica-former-trump-aide-provided-fa.asp" target="_blank">faulty masks</a>, and a Seattle Native health center asked for tests but <a href="https://www.nbcnews.com/news/us-news/native-american-health-center-asked-covid-19-supplies-they-got-n1200246" target="_blank">received body bags instead</a>.</p><p>Meanwhile, federally imposed limits on tribal sovereignty have obstructed tribal governments' efforts to deal with the pandemic themselves. Federal and state governments are <a href="https://www.seattletimes.com/seattle-news/makah-tribe-fights-coronavirus-with-self-reliance-and-extreme-isolation/" target="_blank">challenging tribes' jurisdictional authority</a> to <a href="https://www.azfamily.com/news/mayor-of-page-accused-of-racist-social-media-comment-toward-navajo-nation-president/article_e2e6efd6-8db4-11ea-a8a2-7f6976d702f6.html" target="_blank">close borders to tourists</a> who may carry the virus. South Dakota's governor has <a href="https://www.theguardian.com/us-news/2020/may/14/sioux-coronavirus-roadblocks-south-dakota-governor" target="_blank">threatened legal action</a> against two tribes who set up checkpoints to monitor incoming traffic on their reservations.</p>
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Environmental Injustices on Native Land<p>Energy development and resource extraction have had <a href="https://www.haymarketbooks.org/books/898-all-our-relations" target="_blank">disproportionate impacts</a> on tribes for many years. Today, many Native American leaders worry that ongoing energy production – <a href="https://www.ncsl.org/research/labor-and-employment/covid-19-essential-workers-in-the-states.aspx" target="_blank">an "essential" activity under federal guidelines</a> will bring outsiders into close contact with reservation communities, worsening COVID risks.</p><p>The owners of the Keystone XL oil pipeline have announced that they intend to continue construction, which will bring an influx of workers along the proposed route through Montana, South Dakota and Nebraska. The Rosebud Sioux Tribe in South Dakota and Fort Belknap Indian community in Montana have filed for a <a href="https://www.narf.org/keystone-xl/" target="_blank">temporary restraining order</a>, and a key permit for the pipeline was <a href="https://www.democracynow.org/2020/4/16/headlines/us_judge_revokes_crucial_permit_for_keystone_xl_pipeline" target="_blank">revoked in April 2020</a>, but work continues at the U.S.-Canada border.</p><p>Construction is accelerating on the <a href="https://www.azcentral.com/story/news/politics/border-issues/2020/03/17/border-patrol-waives-laws-border-wall-construction-southern-arizona/5063618002/" target="_blank">southern border wall</a>, which bisects the <a href="http://www.tonation-nsn.gov/" target="_blank">Tohono O'odham reservation</a> in Arizona and Mexico. The Trump administration has <a href="https://www.thenation.com/article/politics/border-coronavirus-military-immigration/" target="_blank">increased patrols at the border</a>, despite the tribe's concern that the patrols' presence is <a href="https://www.usatoday.com/story/news/nation/2020/04/06/coronavirus-cbp-160-cases-covid-19-officers-agents/2958736001/" target="_blank">spreading coronavirus</a> on the reservation.</p><p>And in Bristol Bay, Alaska, a salmon fishing season that brings in thousands of temporary workers is <a href="https://indiancountrytoday.com/news/it-s-hard-when-you-love-something-xlS49l2N20KZjqumwfzZfQ" target="_blank">set to open in June</a> because the federal government has also deemed commercial fishing "<a href="https://www.cisa.gov/sites/default/files/publications/CISA-Guidance-on-Essential-Critical-Infrastructure-Workers-1-20-508c.pdf" target="_blank">essential critical infrastructure</a>." Many local Native villages depend on the fishery for income, but have nonetheless pleaded with state regulators to <a href="https://indiancountrytoday.com/news/urgent-calls-to-close-the-massive-bristol-bay-fishery-8lYsGkUeDUyCBW7FMwpSfA?fbclid=IwAR1710u4rQnriq_MgH2ueQxOFtfGiGiH8I2ZdJRCZS9f28Zl-JNkPLpnzZo" target="_blank">cancel the season</a>. The regional hospital has just four beds for possible COVID-19 patients.</p>
Bold Action in Native Communities<p>Native communities are taking decisive action to reduce the spread of COVID-19. They're imposing aggressive <a href="https://www.nytimes.com/2020/04/09/us/coronavirus-navajo-nation.html" target="_blank">quarantine</a> measures like lockdowns, curfews and border closures. Communities are <a href="https://www.theguardian.com/us-news/2020/mar/18/covidcoronavirus-native-american-lummi-nation-trailblazing-steps" target="_blank">ramping up health care capacity</a> and elder support services, and banishing nontribal members who <a href="https://rapidcityjournal.com/news/local/oglala-sioux-council-banishes-non-member-with-covid-19-from-reservation/article_60b665c3-9d1b-5d48-a576-51774e4fb41a.html" target="_blank">violate travel restrictions</a>.</p><p>Other strategies include helping hunters <a href="https://indiancountrytoday.com/news/ammo-fuel-for-hunters-to-feed-others-Ki3zK6du-ky-UogoB9-aNQ" target="_blank">provide traditional foods</a> to their communities, <a href="https://ndncollective.org/indigenizing-and-decolonizing-community-care-in-response-to-covid-19/" target="_blank">mobilizing to support tribal health care workers</a>, and <a href="https://www.ehn.org/coronavirus-native-americans-2645923635.html" target="_blank">linking the pandemic and the climate crisis</a>. Looking ahead to a post-COVID future, we believe one priority should be attending to <a href="http://www.beacon.org/As-Long-as-Grass-Grows-P1445.aspx" target="_blank">front-line environmental justice struggles</a> that center tribes' sovereignty to act on their own behalf at all times, not just during national crises.</p>
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By Kaya Bulbul
The ocean is our lifeline - we rely on it for the food we eat, the air we breathe, as well as for millions for jobs worldwide.
As we continue to grapple with the issues of overfishing, plastic pollution, and climate change, there exists an opportunity to address these existential threats with new innovations, many of which unidentified or insufficiently supported.
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