News Article | May 23, 2017
US consumer, health, and food safety groups have filed suit against the Food and Drug Administration (FDA), challenging a rule they argue undermines the integrity of the nation's food safety system, according to a release from the Center for Science and the Public Interest (CSPI). Chemical and food manufacturers often seek to add chemicals to food, typically to enhance flavor, add nutrients, or prevent spoilage, the CSPI said, adding that chemicals often leach into foods from processing equipment and packaging. While Congress has required FDA determine that chemical additives are safe before they can be used on food, the FDA rule allows manufacturers to decide for and by themselves—in secret—what can be added to foods. The groups assert this rule is unconstitutional and illegal. "The public expects, and the law demands, that FDA ensure the safety of Americans’ food," CSPI said. The groups suing the FDA for allegedly illegally delegating that authority to self-interested food and chemical manufacturers include the Center for Food Safety (CFS), Breast Cancer Prevention Partners, Center for Science in the Public Interest, Environmental Defense Fund and Environmental Working Group, represented by legal counsel from CFS and the environmental law firm Earthjustice. They also allege that while Congress mandates an open and public process, the FDA allows manufacturers to make these decisions about food ingredients without any disclosure to either the FDA or the public. The lawsuit was filed in the US District Court for the Southern District of New York. Federal law requires the FDA to ensure that substances used in food are safe, taking into account consumers’ entire diet and all exposure to the chemical and similar chemicals, CSPI said. But any substance designated as “generally recognized as safe” (GRAS) by FDA or by a food or chemical company can bypass the rigorous pre-market review and approval process applied to food additives. This exemption was initially created to cover ingredients that are widely known to be safe, such as vegetable oil, but has been applied in recent practice to novel chemicals and is now a loophole that has swallowed the law, the CSPI said. Under pressure from industry, in 1997 and again in 2016, FDA adopted a practice that allows food and chemical manufacturers to decide for themselves, without notice to FDA or the public, that food chemicals are safe—even if the chemicals are new, not widely studied, and not widely accepted as safe, CSPI said. CFS filed suit in 2014 to challenge FDA’s use of an interim rule that initially put this practice into place; and that successful challenge forced FDA to stop using the interim rule and instead finalize the GRAS rule, CSPI said. Today’s lawsuit challenges the final rule that formalizes this practice. “FDA has a duty to ensure the products we buy and feed our families are safe,” said Cristina Stella, staff attorney for the Center for Food Safety and co-counsel in the case. “The secretive GRAS system makes it impossible for FDA to carry out its core responsibility to the public.”
News Article | April 26, 2017
Pres. Donald Trump’s administration has announced plans to dismantle an array of federal efforts to fight global warming, including a program to reduce carbon emissions from coal-fired power plants, a rule limiting methane gas leaks and a mandate that aggressively boosts auto emissions standards. But Trump officials face a major roadblock in their efforts, legal scholars say. It is the U.S. Environmental Protection Agency’s 2009 formal “endangerment finding,” which states carbon dioxide and five other greenhouse gases emitted from smokestacks and other man-made sources “threaten the public health and welfare of current and future generations.” This agency rule, supported by two Supreme Court decisions, legally compels the government to do exactly what its new leaders want to avoid: regulate greenhouse gases. Although EPA Administrator Scott Pruitt publicly doubts a connection between human-produced carbon emissions and global warming, any attempt to undo this rule “would be walking into a legal buzz saw,” says Michael Gerrard, faculty director of the Sabin Center for Climate Change Law at Columbia University. Endangerment is “the linchpin for everything—all of the carbon regulation under the Clean Air Act,” says Patrick Parenteau, a professor of environmental law at Vermont Law School. The rule’s fundamental power is exactly why Pruitt has to remove it, says Myron Ebell, who oversaw the Trump transition team at the EPA. “You can’t just take out the flowers—you have to take out the roots—starting with the endangerment finding,” says Ebell, a senior fellow at the conservative think tank the Competitive Enterprise Institute. “You can undo the Obama climate agenda on the surface by reopening the Clean Power Plant rule, the methane rule, rescinding the [auto emissions] standards and so on. But the underlying foundation remains.” The conservative Web site Breitbart, read widely among Trump’s supporters and still tied to its former publisher, White House adviser Steve Bannon, has attacked Pruitt as a political careerist for reportedly resisting pressure to revoke the finding. The rule rests on a 2007 Supreme Court decision in the case Massachusetts v. EPA, which determined the agency has the authority under the Clean Air Act to regulate greenhouse gases. When the finding itself was later challenged, the Court upheld it. The endangerment finding prevents Pruitt from ignoring climate change or eliminating greenhouse gas regulations outright. The EPA can attempt to water down these standards and regulations, perhaps substantially. But Pruitt “would have to come up with a scientific basis for saying that greenhouse gas emissions do not in fact pose a threat to public health and welfare,” Gerrard says. “That would be a very difficult finding, considering every court that has addressed the issue of the science of climate change has found there to be a solid factual, scientific basis for it.” To begin to remove the endangerment rule, the EPA would have to go through a formal rule-making process. That means inviting public comments, reviewing available evidence and scientifically justifying every point. Formulating and then defending such a document in court would be a big challenge, given it cuts against the legal and scientific consensus linking carbon to climate change. Even Ebell concedes this is a formidable obstacle. “That’s why a lot of people on our side say it’s not worth the trouble,” he says. “The people who disagree with me are not nuts—they are making substantial arguments for why we should not do it.” The endangerment finding has its roots in the waning days of the Clinton administration, when then–EPA General Counsel Jonathan Cannon drafted a legal memo stating the agency had the authority to regulate carbon emissions. At the time this was a novel and counterintuitive idea. CO is a ubiquitous, naturally occurring gas, essential to photosynthesis and other basic processes of life on Earth. It’s not poisonous like smog and other dangerous pollutants targeted by the Clean Air Act. “CO is a different sort of pollutant than many that the EPA regulates,” says Cannon, now a professor at the University of Virginia School of Law. “Its effects are felt over time through the climate system, not as immediate effects on one’s lungs or physical systems.” But the Clean Air Act “has a very broad definition of what a pollutant can be and what harm a pollutant causes,” says George Kimbrell, legal director of the International Center for Technology Assessment and the Center for Food Safety, two related groups among a coalition of environmental organizations that formally petitioned the EPA to regulate carbon in 1999. The law defines “air pollutant” as "any air pollution agent or combination of such agents, including any physical, chemical, biological, radioactive...substance or matter, which is emitted into or otherwise enters the ambient air.” According to Kimbrell, “The breadth of that language suggested greenhouse gas emissions would qualify under the statute.” The language prompted a lawsuit from states and small environmental groups, during the George W. Bush administration, to sue the EPA to force it to regulate carbon. The result was the Supreme Court’s 5–4 2007 Massachusetts decision. Following that ruling, the endangerment finding then spelled out the legal rationale and the scientific basis for regulation. What can the Trump administration do to get out of this regulatory box? It could push Congress to amend the Clean Air Act to explicitly exclude carbon dioxide and other greenhouse gases from the list of air pollutants. But even if it passed the Republican-dominated House, Parenteau notes, such a bill could be effectively opposed by Democrats in the Senate, who have enough votes to hold up or change legislation. . The EPA could also target climate rules not based on the endangerment finding, such as procedures for monitoring and reporting greenhouse gases, according to Gerrard. The most likely outcome, legal scholars say, is a series of incremental battles in which the administration and Congress try to weaken individual climate rules and enforcement—while those efforts are repeatedly challenged in court by states and environmental groups hoping to run out the clock on the Trump administration. “One reason the endangerment finding is important,” Cannon says, “is that, should administrations change, it provides the basis for further climate initiatives.”
News Article | May 21, 2016
Genetically modified salmon will soon make their way to your local grocery stores, as regulators have approved its commercial sale. AquAdvantage Salmon (AAS) of AquaBounty Technologies, Inc. can now sell its genetically modified salmon after Health Canada has found that it is fit for human consumption. The biotechnology company has also received feed safety approval from the Canadian Food Inspection Agency's (CFIA) Animal Feed Division. The agency stated that no nutrition concerns were found from feed ingredients from AAS compared with allowed salmon livestock feed in the region. AquaBounty's CEO Ronald Stotish has gladly expressed enthusiasm about finally being able to produce and market their salmon in Canada. "We thank the scientists in the Ministries of Health, Food Inspection and Fisheries of the Canadian government for carrying out their assessments diligently and confirming the safety of our salmon for both the consumer and the environment," Stotish said (PDF). The company has previously received consent from the U.S. Food and Drug Administration (FDA) for its AAS, and the recent stamp of approval from the Canadian government strengthens its claim that what it produces are nutritious for the consumers and does not pose any environmental threats. The FDA has received backlash from environmentalists for giving the AquaBounty the approval to sell its genetically modified salmon. A lawsuit seeking to overturn the decision was filed by the Center for Food Safety, Food and Water Watch, Friends of the Earth and other environmental organizations. Officials of the Health Canada did a comprehensive analysis of the AAS based on the established guidelines on food safety of recombinant-DNA animals. The assessment included the investigation of four parameters: development of AAS, comparison of nutritional quality and composition of AAS with non-modified salmons, potential toxicity and allergic reactions and the overall health of the AAS. The officials concluded that AAS does not have any food safety issues and noted that AAS-derived fillets are as nutritious and safe as farmed Atlantic salmon. The agency also took into consideration a 2013 report by the Fisheries and Oceans Canada that genetically modified fish products have no direct and indirect risks for human health. © 2017 Tech Times, All rights reserved. Do not reproduce without permission.
News Article | January 26, 2016
Hettich Lab Technology designs, engineers and commercializes software and automated incubation systems for identifying pathogens using elastic light scatter techniques that fire lasers at a pathogen colony to create a light-scatter field that gives the pathogen a pattern or fingerprint. "The use of elastic light-scatter technology could change the way foodborne pathogens are identified," said Klaus-Günter Eberle, Hettich's CEO and general manager. "We are excited about the potential of the technology to advance the process of protecting society from foodborne pathogens." Foodborne pathogens continue to be an international health and safety concern. In the United States, the Centers for Disease Control and Prevention estimates that one in six Americans, or 48 million people, become ill from foodborne illnesses with 128,000 becoming hospitalized and nearly 3,000 deaths. In addition, an estimated cost of $152 billion in medical expenses, lost productivity and business, lawsuits and compromised branding is attributed to foodborne illnesses. "Improving our ability to quickly and accurately detect foodborne pathogens is a top priority for the USDA's Agricultural Research Service," said George Paoli, research microbiologist and lead scientist at the USDA-ARS in Wyndmoor, Pennsylvania. "ARS has supported the development of the BARDOT technology through funding and collaboration with Purdue's Center for Food Safety Engineering. The potential applications of BARDOT (Bacteria Rapid Detection using Optical Scattering Technology) for bacterial classification and identification are intriguing, particularly for the facile, rapid and low-cost detection of bacterial foodborne pathogens, because foodborne pathogen identification often takes days to complete using conventional microbiological detection methods." The USDA-ARS, National Science Foundation and National Institutes of Health all provided funding to the Purdue colleges of Agriculture and Veterinary Medicine to develop the technology, which uses an optical sensor in the detection and identification of foodborne pathogens and other bacteria of interest. "The development of this innovation is a prime example of how research funding from public and private sources can positively lead to innovations to help our global society," said Dan Hasler, president of the Purdue Research Foundation, which is the licenser of the technology. "We are eager to see this technology come to fruition and move to the public." The device, called the Bacteria Rapid Detection using Optical Scattering Technology, or BARDOT, has shown great promise in identifying dangerous pathogens such as listeria, staphylococcus, salmonella, vibrio, and E. coli. Since the technology does not require a reagent, it reduces the cost of the pathogen identification. The technology can be used to test any food source for contamination, changing the model for rapid and definitive identification of pathogens. "The technology can transmit a pathogenic organism fingerprint across the country instantly without the danger of physically transporting the pathogenic organism. This can be achieved without any reagents or assay requirements, which makes this a unique feature for this technology," said J. Paul Robinson, the SVM Professor of Cytomics in the Purdue Department of Basic Medical Sciences, and member of the Purdue Center for Food Safety Engineering who helped develop the technology. "Another attribute is that the technology evaluates every colony on a Petri-dish, so it eliminates or significantly minimizes the sampling bias, and as a result dramatically lowers dramatically the rate of false negatives - something that no other technology in organism identification can claim." Other innovators of this technology are Dan Hirleman, Purdue's chief corporate and global partnerships officer; Arun Bhunia, professor of food science; Bartlomiej Rajwa, research associate in the Department of Basic Medical Sciences; and Euiwon Bae, senior research scientist in the Department of Basic Medical Sciences. The Purdue Center for Food Safety Engineering, under the leadership of director Lisa Mauer, also contributed to the development of the technology. "The Purdue Center for Food Safety Engineering, established as a cooperative agreement with USDA-ARS, has a valuable history of combining engineering and microbiological expertise to develop pathogen detection technologies," Mauer said. "The technologies developed by the center translate science and engineering into practical tools for improving the detection of foodborne hazards." Explore further: Food safety study of beef 'trim' leads to ongoing research collaboration
News Article | February 21, 2017
Artificial insemination, embryo transfer and genetic selection have led to significant improvements in animal breeding in recent years (AFP Photo/Jason Connolly) Boston (AFP) - Gene editing, which has raised ethical concerns due to its capacity to alter human DNA, is being considered in the United States as a tool for improving livestock, experts say. The technique is different than that used in genetically modified organisms (GMOs) because it does not introduce foreign genes, but rather alters already existing DNA. But scientists and consumer groups say there is not enough evidence yet to shed light on the potential risks of gene editing, particularly regarding its trickle-down effects on the environment and the ecosystem. "Gene editing is one of the newest and most promising tools of biotechnology," Alison Van Eenennaam, an expert in animal genetics and biotechnology at the University of California, Davis, told the annual meeting of the American Association for the Advancement of Science. It "enables animal breeders to make beneficial genetic changes, without bringing along unwanted genetic changes," she added. Artificial insemination, embryo transfer and genetic selection have led to significant improvements in animal breeding in recent years. For instance, in the United States, selective reproduction to improve the milk output from cows has meant far fewer cows in the United States -- nine million today compared to 25.6 million in 1944 -- produce 1.6 times as much milk. "Thanks to improvements made in the dairy industry through traditional breeding, a glass of milk today is associated with just one third of the greenhouse gas emissions linked to producing a glass of milk in the 1940s," Van Eenennaam said. Gene editing can complement the toolkit available to breeders today by "precisely introducing desirable genetic variations into livestock breeding programs," she added. This technique has already been used to make certain animals resistant to disease, such as pigs that are resistant to porcine reproductive and respiratory virus. A tuberculosis-resistant form of cattle was also reported recently out of China. Van Eenennaam is working on a gene editing technique that allows cows to be born without horns. Typically, the animals are born with them but undergo a painful process to remove them when they are young so that they don't damage other cows or people working with them. Some breeds, such as Angus cows, naturally carry a genetic mutation that prevents them from growing horns. Gene editing has the ability to modify a normal, identical gene in Holstein cows and insert this same genetic variation seen in the Angus. This trait is then passed down to the cow's offspring. Other teams of geneticists around the world are hoping to benefit from gene editing techniques. For instance, it is now possible to alter chickens so that they only lay eggs that produce female chicks, a practice that can double the output of a chicken farm and curb the cruel practice of killing roosters. Researchers are also working on a variety of chicken that would be resistant to bird flu, a potentially deadly disease that regularly devastates flocks worldwide and can spread to people. Gene editing can also improve plant growth, said Dan Voytas, a professor of genetics and cellular biology at the University of Minnesota who has used the CRISPR/Cas-9 simple yet powerful gene-editing technique to improve soy crops. "We are probably the first genome-edited product to enter the food supply," he told the AAAS conference. "We have a soybean product which produces a healthier cooking oil, it is high in non saturated fat, no transfat." But Doug Gurian-Sherman, a plant pathology expert at the Center for Food Safety, warned that certain applications could be risky. For instance, research that alters the genes of insects and grains to fight resistance to insecticides and herbicides could introduce mutations in nature that modify entire populations of animals and plants in the course of just a few years, potentially destabilizing the food chain and allowing other species to invade. "We don't say it's inherently bad or these crops are inherently dangerous," Michael Hansen, senior staff scientist at Consumers Union, told The New York Times recently. "It's just they raise safety issues, and there should be required safety assessments." In November, a US Department of Agriculture advisory board unanimously recommended that standards for organic foods exclude gene-edited crops even if they were grown without chemical fertilizers. Then, the US Food and Drug Administration said in January that all animals whose genomes have been intentionally altered must be examined for safety, much the same way as new drugs are scrutinized before they hit the market. "It's not yet clear what regulatory status food-animals produced with gene editing will have," said Van Eenennaam.
News Article | February 21, 2017
The technique is different than that used in genetically modified organisms (GMOs) because it does not introduce foreign genes, but rather alters already existing DNA. But scientists and consumer groups say there is not enough evidence yet to shed light on the potential risks of gene editing, particularly regarding its trickle-down effects on the environment and the ecosystem. "Gene editing is one of the newest and most promising tools of biotechnology," Alison Van Eenennaam, an expert in animal genetics and biotechnology at the University of California, Davis, told the annual meeting of the American Association for the Advancement of Science. It "enables animal breeders to make beneficial genetic changes, without bringing along unwanted genetic changes," she added. Artificial insemination, embryo transfer and genetic selection have led to significant improvements in animal breeding in recent years. For instance, in the United States, selective reproduction to improve the milk output from cows has meant far fewer cows in the United States—nine million today compared to 25.6 million in 1944—produce 1.6 times as much milk. "Thanks to improvements made in the dairy industry through traditional breeding, a glass of milk today is associated with just one third of the greenhouse gas emissions linked to producing a glass of milk in the 1940s," Van Eenennaam said. Gene editing can complement the toolkit available to breeders today by "precisely introducing desirable genetic variations into livestock breeding programs," she added. This technique has already been used to make certain animals resistant to disease, such as pigs that are resistant to porcine reproductive and respiratory virus. A tuberculosis-resistant form of cattle was also reported recently out of China. Van Eenennaam is working on a gene editing technique that allows cows to be born without horns. Typically, the animals are born with them but undergo a painful process to remove them when they are young so that they don't damage other cows or people working with them. Some breeds, such as Angus cows, naturally carry a genetic mutation that prevents them from growing horns. Gene editing has the ability to modify a normal, identical gene in Holstein cows and insert this same genetic variation seen in the Angus. This trait is then passed down to the cow's offspring. Other teams of geneticists around the world are hoping to benefit from gene editing techniques. For instance, it is now possible to alter chickens so that they only lay eggs that produce female chicks, a practice that can double the output of a chicken farm and curb the cruel practice of killing roosters. Researchers are also working on a variety of chicken that would be resistant to bird flu, a potentially deadly disease that regularly devastates flocks worldwide and can spread to people. Gene editing can also improve plant growth, said Dan Voytas, a professor of genetics and cellular biology at the University of Minnesota who has used the CRISPR/Cas-9 simple yet powerful gene-editing technique to improve soy crops. "We are probably the first genome-edited product to enter the food supply," he told the AAAS conference. "We have a soybean product which produces a healthier cooking oil, it is high in non saturated fat, no transfat." But Doug Gurian-Sherman, a plant pathology expert at the Center for Food Safety, warned that certain applications could be risky. For instance, research that alters the genes of insects and grains to fight resistance to insecticides and herbicides could introduce mutations in nature that modify entire populations of animals and plants in the course of just a few years, potentially destabilizing the food chain and allowing other species to invade. "We don't say it's inherently bad or these crops are inherently dangerous," Michael Hansen, senior staff scientist at Consumers Union, told The New York Times recently. "It's just they raise safety issues, and there should be required safety assessments." In November, a US Department of Agriculture advisory board unanimously recommended that standards for organic foods exclude gene-edited crops even if they were grown without chemical fertilizers. Then, the US Food and Drug Administration said in January that all animals whose genomes have been intentionally altered must be examined for safety, much the same way as new drugs are scrutinized before they hit the market. "It's not yet clear what regulatory status food-animals produced with gene editing will have," said Van Eenennaam.
News Article | April 8, 2016
The level of inorganic arsenic in infant rice cereal sold in the U.S. would be kept to a maximum of 100 parts per billion under new recommendations by the Food & Drug Administration. Exposure to the toxic element in infants and pregnant women can result in a child’s decreased performance on developmental learning tests, FDA says. FDA’s proposed limit matches the limit set by the European Commission for rice intended for infants and young children. FDA found that most infant rice cereal in the U.S. meets or is close to meeting its new limit. Out of 76 samples from retail stores in the U.S. in 2014, 47% met the standard, and 78% were at or below 110 ppb, FDA’s data show. “The proposed limit is a prudent and achievable step to reduce exposure to arsenic among infants,” says Susan Mayne, director of FDA’s Center for Food Safety & Applied Nutrition. FDA is advising parents to give babies iron-rich infant cereals from multiple grains, not just rice, including oats and barley. Much of the arsenic that accumulates in rice is from naturally occurring sources in soil and water. Manufacturers have been working with rice suppliers, growers, and researchers for many years to lower the amount of arsenic that gets taken up by rice. Baby food manufacturer Gerber claims that its rice cereal is “safe and already meets the guidance level,” because of these combined efforts. Consumer groups, which have long been urging FDA to set a limit for inorganic arsenic in rice food products, are welcoming the proposed limit for infant rice cereal. But they remain concerned by the lack of arsenic limits for other rice-based foods consumed by children and adults. “This is particularly true of children’s ready-to-eat cereals,” says Urvashi Rangan, executive director of the Consumer Reports Food Safety & Sustainability Center. “We believe the FDA can act swiftly to protect public health and set levels on these products,” she says.
News Article | January 4, 2016
Jackson County, Oregon, has just joined the small but growing ranks of “GE-free zones” in the U.S., which prohibit the cultivation of genetically engineered (GE) crops. It’s at least the eighth county in the country to create such an ordinance, and efforts are springing up to pass similar measures in other places. The Jackson County designation was made final on Dec. 22, when a federal judge approved a consent decree protecting the zone. The ordinance was originally passed in May 2014 by the voters of Jackson County, but was challenged in court by two GE alfalfa farmers, who argued that it violated Oregon state law. The challenge was rejected by a federal judge in May, and a court-approved settlement — which upholds the GE-free zone, but allows the alfalfa farmers to keep their crop for the remainder of its useful life — was finally approved in December. There are many different types of genetically modified plants and animals, although GM crops are frequently modified to make them less susceptible to pests. Genetic engineering — especially as it relates to the food system — remains a hot-button issue in the U.S., with a primary concern among members of the public being the safety of GE products in terms of their impacts on public health and the environment. A growing movement has devoted itself to passing GE-labeling laws, for instance, which would identify products containing genetically modified organisms. But when it comes to GE-free farming zones, the concern is largely an economic one. The goal of creating the zones, according to proponents, is to protect non-GE crops from contamination with modified product — a risk they argue has become a threat to the livelihood of traditional and organic farmers. Transgenic contamination is “the mixing of unwanted, unintentional GE content with traditional and/or organic crops or wild plants,” according to George Kimbrell, senior attorney at the Center for Food Safety, an environmental advocacy group promoting organic and sustainable agriculture, and counsel in the Jackson County case. When GE crops are cultivated in close proximity to non-GE crops, bees and other pollinators can carry pollen between the two, spreading the genes from the genetically modified plants. This is a concern on several levels — first, because of federal patent laws protecting the right to produce and sell certain genetically modified organisms, said Elise Higley, a Jackson County-based farmer and executive director of the Our Family Farms Coalition, an advocacy group for traditional farming which helped spearhead the Jackson County ordinance. “It is definitely a risk in that you’re not able to legally save and sell your seed if it has any kind of contamination because of federal patent law,” she said. Beyond the legal considerations, there’s also worry about having contaminated products rejected by domestic organic markets, which advertise their wares as being GE-free, Higley said. And the ability to export to the international market is another consideration as well, according to Kimbrell. “A lot of our export markets…have a very different view of GE crops than the U.S. government does, and they require labeling, they have restrictions, they haven’t approved a number of GE crops that we have approved,” Kimbrell said. “Time and time again, U.S. farmers have lost literally billions of dollars through these contamination incidents.” In 2014, China rejected corn shipments from the U.S. because they contained a banned variety of genetically modified corn produced by Syngenta, an event that experts estimated cost the U.S. agriculture industry nearly $3 billion. To be clear, these losses were not necessarily the result of contamination in the field via pollination, but rather the fact that the shipments themselves included the GE corn variety. However, the incident illustrates the often severe stances of other countries on the shipment and sale of genetically modified organisms. There are also some precedents for monetary losses as a result of contamination in the field. A 2008 report from the International Federation of Organic Agriculture Movements noted that contamination via cross-pollination has resulted in losses for organic farmers in Europe, Canada, the U.S., Korea, Brazil and elsewhere and suggested that “GM contamination can give rise to a wide range of economic impacts beyond those related to legal tolerance standards. These include lost markets, lost sales, lower prices, negative publicity, withdrawal of organic certification and product recalls.” In general, however, there have been few large-scale studies of economic losses due to this type of contamination, said Jennifer Kuzma, professor and director of the Genetic Engineering and Society Center at North Carolina State University. She pointed to one survey conducted by the Food and Water Watch, which found that a third of respondents had experience with contamination and about half of these had been rejected by buyers as a result. However, she noted that the sample size was fairly small, including only 268 responses. But the concerns about coexistence between GE and non-GE farmers are a growing issue, she added. “I think it’s a serious issue, and a lot of ethical questions come up about who reaps the benefits and who bears the cost of insuring a lack of contamination,” Kuzma said. “We’ve heard arguments on both sides, with organic farmers saying that they’re largely responsible for creating these buffer zones. Sometimes they’ll delay planting so the crops don’t pollinate at the same time as a GM farmer’s crops do.” “It seems to me that most of the economic burden right now is on the organic or non-GM producers, and so then one has to ask the question: Is that fair or equitable?” she added. The issue can be argued from both sides, she said. This is where the GE-free zones come into play, Kimbrell said. As there’s currently no national guidance on the separation or coexistence of GE and non-GE agricultural zones, individual localities, such as Jackson County, have started taking matters into their own hands. “Until we have those restrictions on a federal level, until we have liability on the patent holder for contamination, then we need these zones in order to have any alternative to the current dominant paradigm of the GE crop systems,” Kimbrell said. In addition to Jackson County, five counties in California, and at least one in Washington, Hawaii and another in Oregon, have enacted similar ordinances, and more may be on the way. Costilla County in Colorado, for instance, is currently pushing for a GE-free zone, although the ordinance has not yet been enacted. But such regulations are not likely to occur uncontested. Shortly after the Jackson County ordinance received enough signatures for the ballot, for instance, the state of Oregon passed an emergency bill barring any other counties from regulating GE agriculture. The issue remains a knotty one on the scientific side as well. Scientists have largely concluded that genetically modified organisms are safe for human consumption and frequently benefit the environment, although many members of the public remain skeptical and continue to push for more transparent GMO labeling. The added economic concerns for farmers who wish to keep their crops GE-free is just another facet in an already thorny and ongoing debate. And the issue is not likely to become simpler anytime soon. “I think these issues are only going to grow in intensity as organic or non-GM foods become more and more popular,” Kuzma said. “I think we’re going to see more of these food labeling bills and GE-free zones popping up, and I think it’s time we had kind of a national, more public conversation about how we want to approach genetic engineering from a societal context, and to have more open and transparent discussion about the issue in which many types of people can participate.” This is the fuel NASA needs to make it to the edge of the solar system — and beyond What scientists just discovered in Greenland could be making sea level rise even worse For more, you can sign up for our weekly newsletter here, and follow us on Twitter here.
News Article | April 13, 2016
The industry that has blanketed more than 181 million hectares of the world’s farmland with genetically modified (GM) crops is in the middle of a sea change. Improved techniques for altering crop genomes are already bringing a new generation of plant varieties to the market — and around the world, regulators are playing catch-up. “A few brave countries have already made statements,” says Piet van der Meer, a biologist and lawyer at Ghent University in Belgium. “But most are struggling with it.” On 18 April, the US National Academies of Sciences, Engineering and Medicine will begin its first meeting of a committee charged with ending the struggle. The committee, which is sponsored by the US Department of Agriculture (USDA) and two other agencies, has been asked to predict what advances will be made in biotechnology products over the next 5–10 years. It is scheduled to report by the end of the year on the steps that regulators need to take to prepare themselves. The result could inform an ongoing USDA effort to re-assess its process for evaluating engineered crops. Researchers around the world are watching closely (see ‘Global governance’). “Crops travel around the globe,” says René Custers, manager of regulatory and responsible research at VIB, a life-sciences research institute in Ghent. “It is important to see what is happening in the rest of the world.” Many feel that regulations in the United States, which grows more GM crops than any other country, are particularly ripe for change. The USDA itself has acknowledged that it might be over-regulating some crops if they have traits that have already been scrutinized. Also, it uses its authority to restrict the release of ‘plant pests’ as a way to regulate GM crops — an approach that applied widely in the 1980s, when crops were often created using genetic elements from plant viruses or bacteria. But researchers have since developed tools that do not rely on these components. Over the past five years, the USDA has determined that about 30 types of GM plant — from soya beans whose oil has a longer shelf life, to pineapples with rose-coloured flesh — do not fall under its regulatory rubric. Some were made using gene-editing techniques. “One of the things that has to happen is to plug that huge hole,” says Doug Gurian-Sherman, director of sustainable agriculture at the Center for Food Safety, an environmental-advocacy group in Washington DC. “Whether you think they’re over-regulated or under-regulated or just not intelligently regulated, there’s nobody who thinks this is appropriate.” And developers eager to market gene-edited varieties want clarity as to how the USDA will view the crops, says Daniel Voytas, chief science officer at Calyxt, a plant biotechnology company in New Brighton, Minnesota. The agency has already determined that it will not regulate several crops that have been developed using two editing tools — zinc-finger nucleases and TALENs — and it is currently considering a non-browning mushroom that was made using another, CRISPR–Cas9. These crops embody the simplest application of genome modification: deleting a small section of the genome to disrupt a gene. Calyxt, for example, used TALENs to edit a single gene in the parent plant and generate a variety of wheat with improved resistance to powdery mildew. On 11 February, the USDA informed Calyxt that it would not regulate the crop. But more-sophisticated edits — such as rewriting genes or inserting new ones — are around the corner, Voytas says. “We don’t understand how those crop varieties are going to be regulated,” he says. “And they’re already in the works.” On 5 February, the USDA released four broad regulatory scenarios that are open to public comment until 21 April. The draft proposed a definition of “products of biotechnology” that encompasses organisms in which segments of the genome have been deleted, added or altered. “Sometimes you are using these technologies to introduce genetic variation that already exists in wild relatives,” says Custers. “The question is whether or not that differs from traditional plant breeding.” Custers therefore advocates a definition that excludes plants carrying genetic changes that are already present in nature. But including such plants in the definition does not mean that they would be heavily regulated, notes Greg Jaffe, director of biotechnology at the Center for Science in the Public Interest, a consumer advocacy group in Washington DC. “The USDA is capturing them under the rubric, but it sounds like they’re also going to exempt many of them from oversight,” he says. Some activists are unlikely to support the idea. Gurian-Sherman notes that gene-editing technology is still relatively new, can be applied in many ways and sometimes makes unintended genetic changes. “We feel very strongly that this technology still needs to be regulated as we learn more about it,” he says. “Maybe at some point it wouldn’t need to, but this is still a new technology.”
News Article | January 8, 2016
Every year, American farmers spray some 3.5 million pounds of neonicotinoid insecticides over 127 million acres of farmland. That’s according to official Environmental Protection Agency estimates, at least. But the bee-killing chemicals are present in crops on more than twice as many acres because, thanks to an EPA loophole a large swath of land planted with neonic-treated corn, soy, and other crops doesn't count as being treated with pesticides. The difference comes in the application, according to a lawsuit filed Wednesday by a coalition of beekeepers, farmers, and environmental and wildlife conservation groups: The EPA only regulates neonics as a pesticide when they are sprayed on fields. Meanwhile, farmers who use seeds pretreated with neonics—allowing the insecticide to be taken up in every part of the plant, from leaf to pollen—aren’t considered to be using a pesticide, and they aren’t regulated as such. The federal lawsuit filed seeks to change that. "EPA has created an exemption that is so big you could drive a Mack truck through it and allows this vast suite of environmental harms and bee kills and other sort of damage to occur without any oversight," Peter Jenkins, an attorney with the anti-GMO group Center for Food Safety, which is party to the suit, told Minnesota Public Radio on Wednesday. Jeff Anderson, a Minnesota beekeeper who is the lead plaintiff, says that dust from fields planted with treated seeds has drifted onto his hives, as might happen when a field is sprayed with pesticides, killing bees. Many have singled out neonics as the culprit in the troublingly high rates of bee die-offs observed in managed hives in recent years, while the science suggests that a host of pests, chemicals, and environmental influences are behind the losses. But even if bee death is more complicated than one chemical, the EPA itself is now saying that neonics harm bees. However, the agency's first assessment of the insecticides, released Wednesday, says the chemicals are only a risk to bees when applied to cotton and citrus, not corn and vegetable crops. The EPA has not commented on the new lawsuit. Other research, including studies conducted by the EPA, suggest that using pretreated seeds simply isn’t worth it. A 2014 EPA report concluded that seed treatment “provide[s] negligible overall benefits to soybean production in most situations.” A review of 19 papers on neonic treatments conducted by the Center for Food Safety found that 11 studies concluded that the insecticides had “inconsistent” benefits, while eight found that “neonicotinoid treatments did not provide any significant yield benefit.” The plaintiffs say the treated seeds do, however, excel at killing wildlife. “A single seed coated with a neonicotinoid insecticide is enough to kill a songbird,” Cynthia Palmer, director of pesticides science and regulation at the American Bird Conservancy, said in a press release. “There is no justification for EPA to exempt these pesticide delivery devices from regulation.” • For the First Time, the Government Says a Pesticide Harms Bees • Seven Reasons 2015 Was the Sweetest Year Yet for Saving Bees • The Decline in Bees Will Cause a Decline in Healthy Food