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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 -- GE -- 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, Center for Biological Diversity, Friends of the Earth, Cascadia Wildlands, and Center for Food Safety.
In approving the GE salmon, 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. FDA'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 U.S. 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 U.S. rather than Panama, and sell it around the world. Despite this, 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 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 and 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:
Center for Food Safety's mission is to empower people, support farmers, and protect the earth from the harmful impacts of industrial agriculture. Through groundbreaking legal, scientific, and grassroots action, we protect and promote your right to safe food and the environment. CFS's successful legal cases collectively represent a landmark body of case law on food and agricultural issues.(202) 547-9359
"Time and time again, we've watched 'dark money' used to silence the voices our party most needs to hear."
Nevada Democratic Party Chair Judith Whitmer said Friday that progressives won't stop working to stem the flow of untraceable cash into national primary contests after the DNC Resolutions Committee blocked a vote on her proposed dark money ban for the second time.
Whitmer, a DNC member, told Common Dreams that "time and time again, we've watched 'dark money' used to silence the voices our party most needs to hear."
"Our party and our country need strong Democratic candidates willing to speak truth to power, but when their messages can be drowned out in a flood of untraceable expenditures, many candidates are questioning why they should even run," Whitmer said. "Restoring faith in our democracy has never been more urgent, and that all-important work should start in our own primary elections."
Whitmer sponsored the proposed dark money ban alongside fellow DNC member James Zogby, who previously served as chair of the resolutions panel. If approved, the resolution would have prohibited dark money donations in Democratic primary contests and established guidelines for investigating any violations of the ban.
On Thursday, members of the DNC Resolutions Committee—who likely faced pressure from DNC leadership—stayed quiet when the proposed ban was put up for consideration, so the measure did not receive a vote. Had the committee approved the proposal, which was backed by dozens of DNC members, it would have gone to the full DNC for a vote this weekend. (The DNC doesn't publicize membership lists for its standing committees.)
"Although we were disappointed that the Resolutions Committee once again chose not to move our resolution forward, we will keep fighting to make our primaries a fair and level playing field for all candidates," Whitmer told Common Dreams.
Democratic leaders, including President Joe Biden, have repeatedly railed against the scourge of dark money, decried its corrupting influence, and pledged to rein it in—only to balk at pressure for substantive action.
The party's platform, adopted in 2020, states that "we will bring an end to 'dark money' by requiring full disclosure of contributors to any group that advocates for or against candidates."
Yet as the DNC leadership, headed by Chair Jaime Harrison, refuses to act on its rhetoric—and as congressional Republicans block broader legislative efforts to curtail dark money—Democratic incumbents continue to benefit from untraceable donations, which are frequently used to undercut progressive challengers.
All three went on to defeat their progressive primary opponents and win reelection. That pattern played out across the country, though some candidates—including Rep. Summer Lee (D-Pa.), who was aggressively targeted by AIPAC's super PAC—were able to overcome torrents of opposition spending and prevail in November.
"In races around the nation, we've seen these underhanded tactics used to silence debate on critical issues, with competing views buried under an avalanche of dark money-funded messaging."
According to an August 2022 study by the Wesleyan Media Project, nearly 70% of pro-Democratic Senate ads up to that point in last year's election cycle were funded by groups that don't disclose any of their donors.
"Letting our primaries devolve into auctions, rather than elections, has done more than simply create an unequal and unfair playing field," Whitmer said during the DNC Resolutions Committee's last gathering in September. "In races around the nation, we've seen these underhanded tactics used to silence debate on critical issues, with competing views buried under an avalanche of dark money-funded messaging."
At this weekend's DNC meeting in Philadelphia, members are expected to approve a presidential primary calendar that would bump South Carolina up to the first-in-the-nation primary slot—a plan that has drawn criticism from some progressives.
But the issue of dark money is likely to be brushed aside once again.
While Democrats in Congress continue to push legislation to curb dark money across the board in federal elections, progress will be virtually impossible with a closely divided Senate and a Republican-controlled House, leaving internal party rule changes one of the only viable paths toward genuine campaign finance reform in the near future.
Larry Cohen, a DNC member and the board chair of Our Revolution, wrote in an email Friday that the DNC and state-level Democratic parties "have extensive rules relating to the nominating process, which provide many opportunities to block dark and dirty money."
"What happens inside the Democratic Party and inside party caucuses of elected Democrats is frequently ignored by progressives, who are generally more comfortable protesting and working solely outside the party. Of course, protest is essential, and new party-building is fine," Cohen wrote. "But for those of us who believe we must fight in every possible way to advance progressive issues and win real power, we ignore party reform at our peril, even as we demand broader electoral reforms, such as fusion and ranked-choice voting, proportional representation, and more."
"We are basically making demands that we have a livable wage, that we are able to live our lives outdoors, like REI's mission statement includes," said one sales associate at the Beachwood store.
After REI employees in a suburb of Cleveland, Ohio walked off the job Friday morning, the recreational equipment retailer agreed to schedule a union election vote next month and stopped pushing to exclude certain workers.
Following successful union drives at two other REI stores, employees in Beachwood last month filed for a union election with National Labor Relations Board (NLRB) seeking representation with the Retail, Wholesale, and Department Store Union (RWDSU).
John Ginter, a sales associate at the Beachwood REI, told Cleveland-based Ideastream Public Media that he and his co-workers are seeking better working conditions.
"We are basically making demands that we have a livable wage, that we are able to live our lives outdoors, like REI's mission statement includes," he said. "So having a better work-life balance, being able to care for ourselves and to increase benefits for employees across the spectrum, whether or not they are part-time, full-time, whatever that situation would be."
According to the report: "Ginter alleged REI has some 'pretty rigid stipulations' with regard to which employees are eligible for benefits and accrual of sick time. He also said he believes his REI location is 'not living up to our diversity, equity, and inclusion statement.'"
Beachwood workers launched their brief unfair labor practice (ULP) strike Friday as an NLRB hearing got underway at the federal agency's Cleveland office.
\u201c\ud83d\udea8\ud83d\udea8\ud83d\udea8Alert: our store is closed due to our ULP strike. Stand in solidarity with us @rei co-op members and ask the company to #letREIvote https://t.co/HytMzwzBAI\u201d— REI Union Cleveland (@REI Union Cleveland) 1675439795
In a ULP charge that RWDSU filed Thursday with the NLRB, the union claimed REI "engaged in the unlawful surveillance of workers and/or created an impression of surveillance of the workers at the Beachwood store."
RWDSU has also accused REI of putting forth "meritless assertions to delay the election" by claiming that sales leads, bike shop workers, and "casual" employees—or those who work part-time with irregular schedules—should not vote.
"RWDSU vehemently disagrees with REI's objections," the union said in a statement. "It is especially galling because, as the company unnecessarily fights RWDSU in Ohio, it is currently bargaining contracts with workers holding these same classifications at the SoHo, New York and Berkeley, California stores. REI's hypocrisy is union-busting plain and simple and is a meek attempt to exclude more than half of the proposed bargaining unit to be eligible to vote."
\u201cIn a petty move by local management we're locked out for the day. The main office says we can come back tomorrow, but enjoy this video of the type of attitude we have to put up with every day from local management ...\u201d— REI Union Cleveland (@REI Union Cleveland) 1675457892
REI pushed back against RWDSU's characterization of its intentions in a Thursday statement to Axios, saying that the NLRB hearing was "to ensure that all employees who hold the right to vote are included in the voting process."
The agreement reached Friday includes all eligible workers at the location, "a reversal from REI's position last week," according to RWDSU. "The union election will take place on March 3, 2023 from 12:00 pm-6:00 pm ET at the Ohio store."
New York Times labor reporter Noam Scheiber tweeted Friday evening: "One thing I've learned covering labor over the past several years: Your labor rights are typically as robust as the power you and your co-workers can muster at the workplace. This case was a perfect example."
More Perfect Union similarly said, "Strikes work."
\u201cCleveland REI workers went on strike this morning, and just hours later the company agreed to all of their demands. Strikes work.\u201d— More Perfect Union (@More Perfect Union) 1675450448
\u201c\ud83d\udea8\u2757\ufe0fHey @REI: You might want to update your website. \n\nThere is NOTHING respectable about a workplace environment where employees are harassed, intimidated & prevented from exercising their LEGAL RIGHT to vote in a fair union election. \n\nSolidarity with @reiunioncle! #letREIvote\u201d— AFL-CIO (@AFL-CIO) 1675441800
If the Ohio employees vote to form REI's third union nationwide, RWDSU would represent approximately 55 workers there—though RWDSU noted that "the store currently operates at a 60% staffing level of its full capacity, potentially increasing that number to over 70."
As the Beachwood workers prepare for next month's election, contract negotiations are underway in Berkeley, and 10 fired employees—including two bargaining team members—are accusing REI of retaliation, which the company denies.
Meanwhile, in Washington state on Tuesday, REI laid off 167 people, or 8% of headquarters workers. President and CEO Eric Artz said that "in the face of increasing uncertainty, we need to sharpen our focus on the most critical investments and areas of work to best serve our members and grow the co-op over the long term."
One expert called the move a "very welcome step away from what has been decades of demonization."
After decades of criminalization, Australia's government said Friday that it will legalize the prescription of MDMA and psilocybin for the treatment of two medical conditions, a historic move hailed by researchers who have studied the therapeutic possibilities of the drugs.
Australia's Therapeutic Goods Administration (TGA) said in a statement that starting July 1, psychiatrists may prescribe MDMA (3,4-methylenedioxy-methamphetamine), commonly called "Molly" or "ecstasy" by recreational users, to treat post-traumatic stress disorder (PTSD) and psilocybin—the psychedelic prodrug compound in "magic" mushrooms—for treatment-resistant depression.
"These are the only conditions where there is currently sufficient evidence for potential benefits in certain patients," TGA said, adding that the drugs must be taken "in a controlled medical setting."
Advocates of MDMA and psilocybin are hopeful that one day doctors could prescribe them to treat a range of conditions, from alcoholism and eating disorders to obsessive-compulsive disorder.
David Caldicott, a clinical senior lecturer in emergency medicine at Australian National University, toldThe Guardian that Friday's surprise announcement is a "very welcome step away from what has been decades of demonization."
Caldicott said it is now "abundantly clear” that both MDMA and psilocybin "can have dramatic effects" on hard-to-treat mental health problems, and that "in addition to a clear and evolving therapeutic benefit, [legalization] also offers the chance to catch up on the decades of lost opportunity [of] delving into the inner workings of the human mind, abandoned for so long as part of an ill-conceived, ideological 'war on drugs.'"
\u201cFrom 1 July this year, medicines containing the psychedelic substances psilocybin and MDMA can be prescribed by specifically authorised psychiatrists for the treatment of post-traumatic stress disorder and treatment-resistant depression.\n\nRead more: https://t.co/rJI9dRs3M7\u201d— TGA Australia (@TGA Australia) 1675387806
MDMA—which has been criminalized in Australia since 1987—was first patented by German drugmaker Merck in the early 1910s. After World War II the United States military explored possibilities for weaponizing MDMA as a truth serum as part of the MK-ULTRA mind control experiments aimed at creating real-life Manchurian candidates. A crossover from clinical usage in marriage and other therapies in the 1970s and '80s to recreational consumption—especially in the disco and burgeoning rave scenes—in the latter decade sparked a conservative backlash in the form of emergency bans in countries including Australia, the United Kingdom, and the United States. The U.S. Drug Enforcement Administration classifies MDMA and psilocybin as Schedule I substances, meaning they have "no currently accepted medical use and a high potential for abuse."
Patients who've tried MDMA therapy and those who treat them say otherwise. A study published last year by John Hopkins Health found that in a carefully controlled setting, psilocybin-assisted psychotherapy held promise for "significant and durable improvements in depression."
The California-based Multidisciplinary Association for Psychedelic Studies (MAPS)—the world's premier organization for psychedelic advocacy and research—interviewed Colorado massage therapist Rachael Kaplan about her MDMA-assisted therapy for PTSD:
For the majority of my life I prayed to die and fought suicidal urges as I struggled with complex PTSD. This PTSD was born out of chronic severe childhood abuse. Since then, my life has been a journey of searching for healing. I started going to therapy 21 years ago, and since then I have tried every healing modality that I could think of, such as bodywork, energy work, medications, residential treatment, and more. Many of these modalities were beneficial but none of them significantly reduced my trauma symptoms. I was still terrified most of the time...
In my first MDMA-assisted psychotherapy session I was surprised that the MDMA helped me see the world as it was, instead of seeing it through my lens of terror. I thought that the MDMA would alter my perception of reality, but instead, it helped me see... more clearly... The MDMA session was the first time that I was able to stay present, explore, and process what had happened to me. This changed everything... There are no words for the gratitude that I feel.
Jon Lubecky, an American Iraq War combat veteran who tried to kill himself five times, toldNBC's "Today" in 2021 that MDMA therapy—also with MAPS—enabled him "to talk about things I had never brought up before to anyone."
"And it was OK. My body did not betray me. I didn't get panic attacks. I didn't shut down emotionally or just become so overemotional I couldn't deal with anything," he recounted.
"This treatment is the reason my son has a father instead of a folded flag," Lubecky said in a message to other veterans afflicted with PTSD. "I want all of you to be around in 2023 when this is [U.S. Food and Drug Administration]-approved. I know what your suffering is like. You can make it."
MAPS' latest clinical research on MDMA—which is aimed at winning FDA approval—is currently in phase three trials. The Biden administration said last year that it "anticipates" MDMA and psilocybin would be approved by the FDA by 2024 and is "exploring the prospect of establishing a federal task force to monitor" therapeutic possibilities of both drugs.
\u201cFounder and Executive Director of @MAPSnews, @RickDoblin Ph.D., discusses a new #psychedelic study that supports MDMA-assisted therapy as a treatment for post traumatic stress disorder (#PTSD) on @FoxBusiness. \n\nhttps://t.co/im1QEz3vdR\u201d— Psychedelic Science (@Psychedelic Science) 1675357038
Like MDMA, psilocybin—which occurs naturally in hundreds of fungal species and has been used by humans for medicinal, spiritual, and recreational purposes for millennia—remains illegal at the federal level in the U.S., although several states and municipalities have legalized or decriminalized psychedelic mushrooms, or have moved to do so.
There have also been bipartisan congressional efforts to allow patients access to both drugs. Legislation introduced last year by U.S. Sens. Cory Booker (D-N.J.) and Rand Paul (R-Ky.) would permit therapeutic use of certain Schedule I drugs for terminally ill patients. Meanwhile, Reps. Alexandria Ocasio-Cortez (D-N.Y.) and Dan Crenshaw (R-Texas) passed amendments to the 2023 National Defense Authorization Act providing more funding for psychedelic research and making it easier for veterans and active-duty troops suffering from PTSD to try drug-based treatments.