'Major Victory': Federal Court Rejects FDA Approval of 'Frankenfish'

By Andrea Germanos
Food safety campaigners on Thursday welcomed a federal court's finding that the Food and Drug Administration (FDA) violated U.S. law in its approval of genetically engineered salmon.
"This decision underscores what scientists have been telling FDA for years — that creating genetically engineered salmon poses an unacceptable risk if the fish escape and interact with our wild salmon and that FDA must understand that risk to prevent harm," said Steve Mashuda, managing attorney at Earthjustice, one of the organizations representing plaintiffs in the case.
"Our efforts should be focused on saving the wild salmon populations we already have," said Mashuda, "not manufacturing new species that pose yet another threat to their survival."
The lawsuit stems from Earthjustice and Center for Food Safety's 2016 legal challenge to the FDA's approval of the so-called "frankenfish" engineered by aquaculture firm AquaBounty.
Federal Judge Vince Chhabria of the U.S. District for the Northern District of California found that the FDA violated the National Environmental Policy Act (NEPA) and Endangered Species Act (ESA), writing, in part:
[T]he FDA did not adequately explain in its environmental assessment why the potential impacts of the production and growth of engineered salmon will be insignificant. The central problem is that the document failed to conduct the very inquiry it stated was necessary. In the section describing the "approach to assessment," the environmental assessment stated that an analysis of environmental risk would need to consider two probabilities: the probability of "exposure," or a bad event, and the probability of harm that could occur given exposure. The document thoroughly analyzed the probability of exposure, concluding that it was low. But it failed to assess and explain the potential consequences of that low probability being realized.
[...]
The NEPA evaluation addressed the potential impacts of engineered salmon on wild salmon; the ESA analysis was also concerned with wild salmon, albeit more specifically the endangered Gulf of Maine Atlantic salmon. Because the FDA did not sufficiently examine whether the engineered salmon would significantly impact wild salmon under NEPA, it follows that the agency cannot defend its conclusion that the engineered salmon would have no effect at all on Gulf of Maine salmon. Indeed, the fact that the FDA apparently reached a conclusive determination that the AquaBounty salmon would have "no effect" on the Gulf of Maine Salmon in 2010, while the environmental assessment was still under active consideration and five years before the NEPA process was completed, suggests that the agency may have failed to grasp the practical relationship between the two statutes' requirements in this case.
Chhabria sent the assessment back to the FDA, ordering the agency to "reconsider its 'no effect' determination under the ESA together with its revised NEPA evaluation."
Mike Conroy, executive director of the Pacific Coast Federation of Fishermen's Associations, one of the plaintiffs in case, framed the ruling as a clear win for fish and those whose livelihoods depend upon them given the possible ecological consequences of the genetically engineered salmon.
"It's a terrible idea to design genetically engineered 'frankenfish' which, when they escape into the wild (as they inevitably will), could destroy our irreplaceable salmon runs," said Conroy. "Once engineered genes are introduced into the wild salmon gene pool," he added, "it cannot be undone."
Conroy further hailed the ruling as "a major victory for wild salmon, salmon fishing families and dependent communities, and salmon conservation efforts everywhere."
According to Center for Food Safety legal director George Kimbrell, who was counsel in the case, Thursday's decision marks "a vital victory for endangered salmon and our oceans."
"Genetically engineered animals create novel risks and regulators must rigorously analyze them using sound science, not stick their head in the sand as officials did here," he said.
"The absolute last thing our planet needs right now," added Kimbrell, "is another human-created crisis like escaped genetically engineered fish running amok."
Reposted with permission from Common Dreams.
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By Gwen Ranniger
Fertility issues are on the rise, and new literature points to ways that your environment may be part of the problem. We've rounded up some changes you can make in your life to promote a healthy reproductive system.
Infertility and Environmental Health: The Facts
<ul> <li>Sperm count is declining steeply, significantly, and continuously in Western countries, with no signs of tapering off. Erectile dysfunction is on the rise, and women are facing increasing rates of miscarriage and difficulty conceiving.</li><li>Why? A huge factor is our environmental health. Hormones (particularly testosterone and estrogen) are what make reproductive function possible, and our hormones are increasingly being negatively affected by harmful, endocrine-disrupting chemicals commonplace in the modern world—in our homes, foods, and lifestyles.</li></ul>What You Can Do About It
<p>It should be noted that infertility can be caused by any number of factors, including medical conditions that cannot be solved with a simple change at home.</p><p><em>If you or a loved one are struggling with infertility, our hearts and sympathies are with you. Your pain is validated and we hope you receive answers to your struggles.</em></p><p>Read on to discover our tips to restore or improve reproductive health by removing harmful habits and chemicals from your environment.</p>Edit Your Health
<ul><li>If you smoke, quit! Smoking is toxic, period. If someone in your household smokes, urge them to quit or institute a no-smoking ban in the house. It is just as important to avoid secondhand smoke.</li><li>Maintain a healthy weight. Make sure your caloric intake is right for your body and strive for moderate exercise.</li><li>Eat cleanly! Focus on whole foods and less processed meals and snacks. Studies have found that eating a Mediterranean-style diet is linked to increased fertility.</li><li>Minimize negative/constant stress—or find ways to manage it. Hobbies such as meditation or yoga that encourage practiced breathing are great options to reduce the physical toll of stress.</li></ul>Edit Your Home
<p>We spend a lot of time in our homes—and care that what we bring into them will not harm us. You may not be aware that many commonly found household items are sources of harmful, endocrine-disrupting compounds. Read on to find steps you can take—and replacements you should make—in your home.</p><p><strong>In the Kitchen</strong></p><ul> <li>Buy organic, fresh, unprocessed foods whenever possible. <a href="https://www.ehn.org/clean-grocery-shopping-guide-2648563801.html" target="_blank">Read our grocery shopping guide for more tips about food.</a></li><li>Switch to glass, ceramics, or stainless steel for food storage: plastics often contain endocrine-disrupting chemicals that affect fertility. <a href="https://www.ehn.org/bpa-pollution-2645493129.html" target="_blank" rel="noopener noreferrer">Learn more about the dangers of plastic here.</a></li><li>Ban plastic from the microwave. If you have a plastic splatter cover, use paper towel, parchment paper, or an upside-down plate instead.</li><li>Upgrade your cookware: non-stick may make life easier, but it is made with unsafe chemical compounds that seep into your food. Cast-iron and stainless steel are great alternatives.</li><li>Filter tap water. Glass filter pitchers are an inexpensive solution; if you want to invest you may opt for an under-the-sink filter.</li><li>Check your cleaning products—many mainstream products are full of unsafe chemicals. <a href="https://www.ehn.org/how-to-shop-for-cleaning-products-while-avoiding-toxics-2648130273.html" target="_blank" rel="noopener noreferrer">Check out our guide to safe cleaning products for more info</a>.</li></ul><p><strong>In the Bathroom </strong></p><ul> <li>Check the labels on your bathroom products: <em>fragrance-free, paraben-free, phthalate-free</em> and organic labels are all great signs. You can also scan the ingredients lists for red-flag chemicals such as: triclosan, parabens, and dibutyl phthalate. Use the <a href="https://www.ewg.org/skindeep/" target="_blank">EWG Skin Deep database</a> to vet your personal products.</li><li>Ditch the vinyl shower curtain—that new shower curtain smell is chemical-off gassing. Choose a cotton or linen based curtain instead.</li><li>Banish air fresheners—use natural fresheners (an open window, baking soda, essential oils) instead.</li></ul><p><strong>Everywhere Else</strong></p><ul><li>Remove wall-to-wall carpet. If you've been considering wood or tile, here's your sign: many synthetic carpets can emit harmful chemicals for years. If you want a rug, choose wool or plant materials such as jute or sisal.</li><li>Prevent dust build-up. Dust can absorb chemicals in the air and keep them lingering in your home. Vacuum rugs and wipe furniture, trim, windowsills, fans, TVs, etc. Make sure to have a window open while you're cleaning!</li><li>Leave shoes at the door! When you wear your shoes throughout the house, you're tracking in all kinds of chemicals. If you like wearing shoes inside, consider a dedicated pair of "indoor shoes" or slippers.</li><li>Clean out your closet—use cedar chips or lavender sachets instead of mothballs, and use "green" dry-cleaning services over traditional methods. If that isn't possible, let the clothes air out outside or in your garage for a day before putting them back in your closet.</li><li>Say no to plastic bags!</li><li>We asked 22 endocrinologists what products they use - and steer clear of—in their homes. <a href="https://www.ehn.org/nontoxic-products-2648564261.html" target="_blank">Check out their responses here</a>.</li></ul>Learn More
<ul><li>For more information and action steps, be sure to check out <em>Count Down: How Our Modern World Is Threatening Sperm Counts, Altering Male and Female Reproductive Development, and Imperiling the Future of the Human Race</em> by EHS adjunct scientist Shanna Swan, PhD: <a href="https://www.shannaswan.com/" target="_blank" rel="noopener noreferrer">available for purchase here.</a></li><li><a href="https://www.ehn.org/st/Subscribe_to_Above_The_Fold" target="_blank" rel="noopener noreferrer">Sign up for our Above the Fold Newsletter </a>to stay up to date about impacts on the environment and your health.</li></ul>The irony hit Katherine Kehrli, the associate dean of Seattle Culinary Academy, when one of the COVID-19 pandemic's successive waves of closures flattened restaurants: Many of her culinary students were themselves food insecure. She saw cooks, bakers, and chefs-in-training lose the often-multiple jobs that they needed simply to eat.