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George Kimbrell, Senior Attorney, Center for Food Safety, (571) 527-8618, firstname.lastname@example.org
Brettny Hardy, Earthjustice, (415) 217-2142, email@example.com
Dune Lankard, Center for Biological Diversity, (907) 952-5265, firstname.lastname@example.org
A broad coalition of environmental, consumer and commercial and recreational fishing organizations today sued the U.S. Food and Drug Administration for approving the first-ever genetically engineered food animal, an Atlantic salmon engineered to grow quickly. The man-made salmon was created by AquaBounty Technologies, Inc. with DNA from three fish: Atlantic salmon, Pacific king salmon and Arctic ocean eelpout. This marks the first time any government in the world has approved a GE animal for commercial sale and consumption.
The plaintiff coalition, jointly represented by legal counsel from Center for Food Safety and Earthjustice, includes Pacific Coast Federation of Fishermen's Associations, Institute for Fisheries Resources, Golden Gate Salmon Association, Kennebec Reborn, Friends of Merrymeeting Bay, Ecology Action Centre, Food & Water Watch, the Center for Biological Diversity, Friends of the Earth, Cascadia Wildlands and Center for Food Safety.
In approving the GE salmon, the FDA determined it would not require labeling of the GE fish to let consumers know what they are buying, which led Congress to call for labeling in the 2016 omnibus spending bill. The agency's approval also ignored comments from nearly 2 million people opposed to the approval because the agency failed to analyze and prevent the risks to wild salmon and the environment, as well as fishing communities, including the risk that GE salmon could escape and threaten endangered wild salmon stocks.
AquaBounty's GE salmon will undertake a 5,000-mile journey to reach U.S. supermarkets. The company plans to produce the GE salmon eggs on Prince Edward Island, Canada. The GE salmon will then be grown to market-size in a facility in Panama, processed into fillets, and shipped to the United States for sale. That complicated scheme is only for the initial approval, however. AquaBounty has publicly announced plans to ultimately grow its GE fish in the United States rather than Panama, and sell it around the world. Despite this the FDA's approval only considered the current plans for the far-flung facilities in Canada and Panama, leaving the risk of escape and contamination of U.S. salmon runs unstudied.
The lawsuit challenges the FDA's claim that it has authority to approve and regulate GE animals as "animal drugs" under the 1938 Federal Food, Drug, and Cosmetic Act. Those provisions were meant to ensure the safety of veterinary drugs administered to treat disease in livestock and were not intended to address entirely new GE animals that can pass along their altered genes to the next generation. The approval of the GE salmon opens the door to other genetically engineered fish and shellfish, as well as chickens, cows, sheep, goats, rabbits and pigs that are reportedly in development.
The lawsuit also highlights FDA's failure to protect the environment and consult wildlife agencies in its review process, as required by federal law. U.S. Atlantic salmon, and many populations of Pacific salmon, are protected by the Endangered Species Act and in danger of extinction. Salmon is a keystone species and unique runs have been treasured by residents for thousands of years. Diverse salmon runs today sustain thousands of American fishing families, and are highly valued in domestic markets as a healthy, domestic, "green" food.
When GE salmon escape or are accidentally released into the environment, the new species could threaten wild populations by mating with endangered salmon species, outcompeting them for scarce resources and habitat, and/or introducing new diseases. Studies have shown that there is a high risk for GE organisms to escape into the natural environment, and that GE salmon can crossbreed with native fish. Transgenic contamination has become common in the GE plant context, where contamination episodes have cost U.S. farmers billions of dollars over the past decade. In wild organisms like fish, it could be even more damaging.
The world's preeminent experts on GE fish and risk assessment, as well as biologists at U.S. wildlife agencies charged with protecting fish and wildlife heavily criticized the FDA decision for failing to evaluate these impacts. FDA ignored their concerns in the final approval.
Statements from counsel and plaintiff coalition:
"FDA's decision is as unlawful as it is irresponsible," said George Kimbrell, senior attorney for Center for Food Safety and co-counsel for the plaintiffs. "This case is about protecting our fisheries and ocean ecosystems from the foreseeable harms of the first-ever GE fish, harms FDA refused to even consider, let alone prevent. But it's also about the future of our food: FDA should not, and cannot, responsibly regulate this GE animal, nor any future GE animals, by treating them as drugs under a 1938 law."
"FDA has not answered crucial questions about the environmental risks posed by these fish or what can happen when these fish escape," said Earthjustice attorney Brettny Hardy, also co-counsel for plaintiffs. "We need these answers now and the FDA must be held to a higher standard. We are talking about the mass production of a highly migratory GE fish that could threaten some of the last remaining wild salmon on the planet. This isn't the time to skimp on analysis and simply hope for the best."
"Atlantic salmon populations including our endangered Gulf of Maine fish are hanging on by a thread -- they can't afford additional threats posed by GE salmon," said Ed Friedman from Friends of Merrymeeting Bay, one of the parties who successfully petitioned to classify most Maine Atlantic salmon as endangered. "The law requires agencies like FDA, who aren't fisheries biologists, to get review and approval from scientists with that expertise. FDA's refusal to do this before allowing commercialization of GE salmon is not only irresponsible, it violates the law."
"On Prince Edward Island and across Atlantic Canada, indigenous peoples, anglers and community groups are working hard to protect and restore endangered salmon populations and rivers. Genetic contamination threatens all this work and in return there is little or no economic benefit to the region," said Mark Butler, policy director at Ecology Action Centre in Nova Scotia.
"There's never been a farmed salmon that hasn't eventually escaped into the natural environment. Why should we believe that long term, these frankenfish won't be the same?" asked Golden Gate Salmon Association executive director John McManus.
"Once they escape, you can't put these transgenic fish back in the bag. They're manufactured to outgrow wild salmon, and if they cross-breed, it could have irreversible impacts on the natural world," said Dune Lankard, a salmon fisherman and the Center for Biological Diversity's Alaska representative. "This kind of dangerous tinkering could easily morph into a disaster for wild salmon that will be impossible to undo."
"FDA's action threatens and disrespects the wild salmon ecosystems, cultures and industries that are treasured here in the Pacific Northwest and Alaska," said Gabriel Scott, Alaska legal director for Cascadia Wildlands. "These folks think a salmon is just a packet of protein, but we in Salmon Nation know better. From Alaska to California, Americans are intimately related with diverse runs of salmon and we've learned their unique attributes and incredible value. We've worked very hard to be good stewards of our natural heritage, and refuse to allow that to be undone by one company's irresponsible experiment."
"The FDA has failed to adequately examine the risks associated with transgenic salmon," said Wenonah Hauter, executive director of Food & Water Watch. "The long term effects of people eating genetically modified foods have never been adequately addressed -- and this GE salmon is no exception. This fish is unnecessary, so why take the risk?"
"It's clear that the market has rejected GE salmon despite FDA's reckless approval," said Dana Perls, food and technology campaigner for Friends of the Earth. "Major retailers including Costco, Safeway and Kroger won't sell it and polls show the vast majority of people don't want to eat it. Yet under this approval it won't be labeled, violating our fundamental right to know what we are feeding our families."
For more information, visit: https://www.centerforfoodsafety.org/issues/309/ge-fish or https://www.biologicaldiversity.org/campaigns/ge_seafood.
At the Center for Biological Diversity, we believe that the welfare of human beings is deeply linked to nature — to the existence in our world of a vast diversity of wild animals and plants. Because diversity has intrinsic value, and because its loss impoverishes society, we work to secure a future for all species, great and small, hovering on the brink of extinction. We do so through science, law and creative media, with a focus on protecting the lands, waters and climate that species need to survive.(520) 623-5252
The program "presents a threat to the integrity of traditional Medicare, and an opportunity for corporations to take money from taxpayers while denying care to beneficiaries," said Physicians for a National Health Program.
A national physician group this week called for the complete termination of a Medicare privatization scheme that the Biden White House inherited from the Trump administration and later rebranded—while keeping intact its most dangerous components.
Now known as the Accountable Care Organization Realizing Equity, Access, and Community Health (ACO REACH) Model, the experiment inserts a for-profit entity between traditional Medicare beneficiaries and healthcare providers. The federal government pays the ACO REACH middlemen to cover patients' care while allowing them to pocket a significant chunk of the fee as profit.
The rebranded pilot program, which was launched without congressional approval and is set to run through at least 2026, officially began this month, and progressive healthcare advocates fear the experiment could be allowed to engulf traditional Medicare.
In a Tuesday letter to Health and Human Services Secretary Xavier Becerra and Centers for Medicare and Medicaid Services Administrator Chiquita Brooks-LaSure, Physicians for a National Health Program (PNHP) argued that ACO REACH "presents a threat to the integrity of traditional Medicare, and an opportunity for corporations to take money from taxpayers while denying care to beneficiaries."
The group, which advocates for a single-payer healthcare system, voiced alarm over the Biden administration's decision to let companies with records of fraud and other abuses take part in the ACO REACH pilot, which automatically assigns traditional Medicare patients to private entities without their consent.
CMS said in a press release Tuesday that "the ACO REACH Model has 132 ACOs with 131,772 healthcare providers and organizations providing care to an estimated 2.1 million beneficiaries" for 2023.
"As we have stated, PNHP believes that the REACH program threatens the integrity of traditional Medicare and should be permanently ended," Dr. Philip Verhoef, the physician group's president, wrote in the new letter. "Whether or not one agrees with this statement, we should all be able to agree that companies found to have violated the rules have no place managing the care of our Medicare beneficiaries."
Among the concerning examples PNHP cited was Clover Health, which has operated so-called Direct Contracting Entities (DCEs)—the name of private middlemen under the Trump-era version of the Medicare pilot—in more than a dozen states, including Arizona, Florida, Georgia, and New York.
PNHP noted that in 2016, CMS fined Clover—a large Medicare Advantage provider—for "using 'marketing and advertising materials that contained inaccurate statements' about coverage for out-of-network providers, after a high volume of complaints from patients who were denied coverage by its MA plan. Clover had failed to correct the materials after repeated requests by CMS."
Humana, another large insurer with its teeth in the Medicare privatization pilot, "improperly collected almost $200 million from Medicare by overstating the sickness of patients," PNHP observed, citing a recent federal audit.
"It appears that in its selection process [for ACO REACH], CMS did not prevent the inclusion of companies with histories of such behavior," Verhoef wrote. "Given these findings, we are concerned that CMS is inappropriately allowing these DCEs to continue unimpeded into ACO REACH in 2023."
\u201cOur full letter to the @HHSGov secretary and @CMSGov administration highlighting troubling trends in Direct Contracting and REACH, and asking them to cancel this failed experiment: https://t.co/fnAT18CAtr\u201d— Physicians for a National Health Program (@Physicians for a National Health Program) 1674090685
While the Medicare pilot garnered little attention from lawmakers when the Trump administration first launched it during its final months in power, progressive members of Congress have recently ramped up scrutiny of the program.
Last month, Sen. Elizabeth Warren (D-Mass.) and Rep. Pramila Jayapal (D-Wash.) led a group of lawmakers in warning that ACO REACH "provides an opportunity for healthcare insurers with a history of defrauding and abusing Medicare and ripping off taxpayers to further encroach on the Medicare system."
"We have long been concerned about ensuring this model does not give corporate profiteers yet another opportunity to take a chunk out of traditional Medicare," the lawmakers wrote, echoing PNHP's concerns. "The continued participation of corporate actors with a history of fraud and abuse threatens the integrity of the program."
"Ordinary people's private financial records are being siphoned indiscriminately into a massive database, with access given to virtually any cop who wants it," said the ACLU's Nathan Freed Wessler.
"These records paint a damning portrait of government overreach."
That's how Nathan Freed Wessler, deputy director of the ACLU's Speech, Privacy, and Technology Project, and Fikayo Walter-Johnson, a former paralegal with the project, introduced over 200 documents obtained via public records request and released Wednesday on the civil liberties group's website.
The national ACLU and its Arizona arm sought the records after U.S. Senate Finance Committee Chair Ron Wyden (D-Ore.) revealed last year that "Homeland Security Investigations (HSI), a law enforcement component of the Department of Homeland Security (DHS), was operating an indiscriminate and bulk surveillance program that swept up millions of financial records about Americans."
Following a February 2022 briefing with senior HSI personnel, Wyden wrote a March letter urging DHS Inspector General Joseph Cuffari to launch a probe into the Transaction Record Analysis Center (TRAC)—a nonprofit created as a result of a settlement between the Arizona attorney general's office and Western Union, a financial services company that fought in state court against the AG's attempt to obtain money transfer records.
\u201cThis broad collection of our personal data raised privacy concerns, so we submitted a public records request to learn more.\n\nWhat we found is extremely alarming.\u201d— ACLU (@ACLU) 1674045961
As the ACLU released records about TRAC, Wyden on Wednesday shared a new letter requesting that "the Department of Justice (DOJ) Office of Inspector General (OIG) investigate the Federal Bureau of Investigation (FBI) and Drug Enforcement Administration's (DEA) relationship" with the Arizona-based clearinghouse.
"My oversight activities over the past year have uncovered troubling information, revealing that the scale of this government surveillance program is far greater than was previously reported," Wyden wrote to DOJ Inspector General Michael Horowitz.
"Between October and December of 2022, my office received information from three other money transfer companies—Euronet (RIA Envia), MoneyGram, and Viamericas—which confirmed that they also delivered customer data in bulk to TRAC, in response to legal demands from HSI and other governmental agencies," the senator divulged.
Some customs summonses—a form of subpoena—applied to transfers of $500 or more between any U.S. state and 22 other countries and one U.S. territory. Those summonses were withdrawn "just 10 days after HSI had briefed my staff" in February, Wyden noted, adding that HSI has not yet scheduled his requested follow-up briefing.
\u201c"Hundreds of federal, state and local U.S. law-enforcement agencies have access without court oversight to a database of more than 150M money transfers"\n\nWyden: TRAC is "an all-you-can-eat buffet of Americans\u2019 personal financial data"\n\nhttps://t.co/Z84CnUfnIp\u201d— Alex Gladstein \ud83c\udf0b \u26a1 (@Alex Gladstein \ud83c\udf0b \u26a1) 1674064852
Summarizing the documents acquired by the ACLU, Freed Wessler and Walter-Johnson wrote:
From 2014 to 2021, Arizona attorneys general issued at least 140 administrative subpoenas to money transfer companies, each requesting that the company periodically provide customer transaction records for the next year. Those subpoenas were issued under the same state statute that the Arizona Court of Appeals held in 2006 could not be used for these kinds of indiscriminate requests for money transfer records. This means the Arizona attorney general's office knowingly issued 140 illegal subpoenas to build an invasive data repository.
The documents we obtained reveal the enormous scale of this surveillance program. According to the minutes of TRAC board meetings we obtained, the database of people's money transfer records grew from 75 million records from 14 money service businesses in 2017 to 145 million records from 28 different companies in 2021. By 2021, 12,000 individuals from 600 law enforcement agencies had been provided with direct log-in access to the database. By May 2022, over 700 law enforcement entities had or still have access to the TRAC database, ranging from a sheriff's office in a small Idaho county, to the Los Angeles and New York police departments, to federal law enforcement agencies and military police units.
As Freed Wessler told The Wall Street Journal, which exclusively reported on the materials, "Ordinary people's private financial records are being siphoned indiscriminately into a massive database, with access given to virtually any cop who wants it."
The Journal also spoke with TRAC director Rich Lebel, who "said the program has directly resulted in hundreds of leads and busts involving drug cartels and other criminals seeking to launder money," and "because money services companies don't have the same know-your-customer rules as banks, bulk data needs to be captured to discern patterns of fraud and money laundering."
According to the newspaper:
Mr. Lebel said TRAC has never identified a case in which a law enforcement official has accessed data improperly or the database has been breached by outsiders. The program has seen an increase in use in recent years because of the surging opioid crisis in the U.S., he said.
Law-enforcement agencies use TRAC's data to establish patterns in the flow of funds suspected of being linked to criminal activity, Mr. Lebel said, and the more comprehensive the data, the better the analysis. TRAC manages data that law enforcement provides, he said, and what it is receiving and storing is often in flux.
While declining to discuss TRAC's funding, Mr. Lebel said the nonprofit was originally stood up with money from the Western Union settlement that has since been exhausted. Mr. Wyden and others have said TRAC is federally funded.
Wyden wrote in his letter to Horowitz that "this unorthodox arrangement between state law enforcement, DHS, and DOJ agencies to collect bulk money transfer data raises a number of concerns about surveillance disproportionately affecting low-income, minority, and immigrant communities."
"Members of these communities are more likely to use money transfer services because they are more likely to be unbanked, and therefore unable to send money using electronic checking or international bank wire transfers, which are often cheaper," he explained. "Moreover, money transfer businesses are not subject to the same protections as bank-based transactions under the Right to Financial Privacy Act."
The senator's office said Wednesday that he "is working on legislation to close legal loopholes and ensure people who use money transfer services have the same privacy as those who use banks or money transfer apps."
Freed Wessler and Walter-Johnson also highlighted that "because members of marginalized communities rely heavily on these services rather than traditional banks, the burden of this government surveillance falls disproportionately on those already most vulnerable to law enforcement overreach."
"The government should not be allowed to abuse subpoenas and sweep up millions of records on a huge number of people without any basis for suspicion," the pair argued. "This financial surveillance program is built on repeated violations of the law and must be shut down."
"The campus is thriving, but many faculty are not," said one striking professor. "Management needs to invest in resources that strengthen our entire community."
Hundreds of University of Illinois Chicago faculty members went on strike Tuesday after nine months of deadlocked contract negotiations over pay and student mental health resources.
The approximately 900 members of the UIC United Faculty union have been working without contracts since August. In November, 97% of the 77% of faculty who voted opted to strike. The union announced late Monday that its members would walk off the job the following day after a marathon 12-hour negotiation session failed to produce a deal.
“We started bargaining this contract back in April, and we've made some progress since then. But we have not won yet," UIC United Faculty president Aaron Krall toldBlock Club Chicago.
\u201c"Our students have a lot of needs that aren't being met."\n\nThe University of Illinois Chicago works because the faculty members of @UICUF do. They're on strike for a #FairContractNow to get the resources students and educators need to thrive. #WeLoveUIC\u201d— AFT (@AFT) 1674064832
According to the Chicago Sun-Times:
The union is striking for higher minimum salaries, bigger pay raises that match inflation, mental health support for students, better job security for non-tenure track faculty, learning disability assessments for students, and more.
The UIC administration is offering raises of 17% over four years, averaging 4.25% per year, the union said. That figure is composed of merit raises and other specific pools of raises that do not apply to all union members across the board.
Union leaders called that offer insufficient, and said "seven years of record enrollments and over a billion dollars in unrestricted reserve funds" was "evidence that the university can afford to take demands for faculty raises seriously."
"The campus is thriving, but many faculty are not," UIC United Faculty negotiator Nicole Nguyen said in a statement. "We have spent the past three years scrambling to mitigate the effects of the pandemic, and our whole community—students and faculty—are exhausted. Management needs to invest in resources that strengthen our entire community."
\u201cFaculty with @UICUF are picketing across the UIC campus this morning on Day 1 of their indefinite strike.\n\nThere's a rally at noon with mayoral candidate Brandon Johnson, @AFTunion President Randi Weingarten and more\u201d— Nader Issa (@Nader Issa) 1673977525
Some UIC faculty also say they are working more to help students deal with mental health issues.
"I surveyed my students on the first day of class and asked what they perceived as the biggest challenges in need of intervention. Almost all listed mental health," Michael H. Pasek, an assistant psychology professor at the school, tweeted last week. "It's no wonder faculty... are about to strike over students' mental health resources."
Interim UIC chancellor Javier Reyes and acting provost and vice chancellor for academic affairs Karen Colley called the strike "disappointing" and "not in the best interest of the university or our students."
"UIC values the faculty for their key role in upholding and championing the university's academic mission," Reyes and Colley said in a joint statement. "Based on the shared principles between all involved, the university remains optimistic that a fair and beneficial bargaining agreement can be achieved."
Speaking in support of the striking faculty, Randi Weingarten, president of the American Federation of Teachers, asserted that "if we care about kids' academic success, if we care about their future, it is vitally important on this campus to have the mental health support and the other diagnostic testing and other support they need to thrive."