News Article | November 25, 2015
A breed of fast-growing Atlantic salmon rocketed to celebrity status on 19 November when it became the first genetically engineered animal to be approved for human consumption in the United States. The landmark decision by the US Food and Drug Administration (FDA) releases the ‘AquAdvantage’ salmon from two decades of regulatory limbo — but it could also revitalize an industry that has waited a long time for any sign that its products might make it to market. “It opens up the possibility of harnessing this technology,” says Alison Van Eenennaam, an animal geneticist at the University of California, Davis. “The regulatory roadblock had really been disincentivizing the world from using it.” The FDA decision comes at a time when the US government is re-evaluating how it regulates genetically engineered crops and animals. On 2 July, the White House Office of Science and Technology Policy said that it will update those regulations — for the first time since 1992 — over the next year. And at a meeting on 18 November, the US Department of Agriculture (USDA) discussed preliminary plans to revise its guidelines for genetically engineered crops. A key driving force for these discussions is the recognition that current regulations may not cover crops and animals engineered using cutting-edge techniques, such as the CRISPR–Cas9 system, that allow researchers to make targeted changes to the genome. The USDA has already determined that its regulations do not apply to several genome-edited crops. Van Eenennaam says that it is still unclear how the FDA will regulate animals that have been engineered using that technology. “There is a lot going on these days,” says Greg Jaffe, director of biotechnology at the Center for Science in the Public Interest in Washington DC. “But obviously, up until the decision about the salmon, people were mostly focusing on the crop side.” AquaBounty Technologies, based in Maynard, Massachusetts, filed its first application to the FDA for approval of the salmon in 1995. The agency completed its food-safety assessment in 2010, and released its environmental-impact statement at the end of 2012. The long delay between the completion of those steps and a final decision led to rumours of political interference. But Laura Epstein, a senior policy analyst for the FDA’s Center for Veterinary Medicine, says that the approval took so long because it was the first of its kind. “With most products that are the first of its kind, we are very careful,” she says. The agency also had to wade through many public comments before it could issue a decision, she adds. It is unclear how the salmon will fare on the market. AquAdvantage fish produce extra growth hormone, allowing them to grow to market size in 18 months, rather than the usual 3 years. In the time since AquaBounty first filed for approval, fisheries have bred conventional salmon that grow just as fast, says Scott Fahrenkrug, chief executive of Recombinetics, an animal-biotechnology firm in St Paul, Minnesota. Then there is the matter of consumer acceptance: several grocery chains have said that they will not carry the salmon, which, even at full production, would amount to only a tiny fraction of total US salmon imports. “It’s a drop in the bucket,” says Jaffe. “Consumers would have to hunt to find salmon that are genetically engineered, as opposed to avoiding them.” Still, the FDA’s approval met with swift opposition from some environmental and food-safety groups. Although AquaBounty uses physical and biological safeguards to reduce the chance that its salmon will escape into the wild, opponents fear that an accidental release could alter natural ecosystems. They are also unhappy that the FDA will allow the fish to be sold without any label to indicate that it is genetically engineered. “Huge numbers of people have said, ‘Yes, we want it labelled’,” says Jaydee Hanson, a senior policy analyst at the Center for Food Safety, an environmental-advocacy group in Washington DC. “If this is such a good product, the company itself should be saying it will label it.” The FDA declined to comment on whether other applications for genetically engineered animals are in the regulatory pipeline. But Fahrenkrug says that his company is developing several such animals, including cattle that do not have to be dehorned and pigs that do not need to be castrated. Recombinetics’ animals are engineered using genome-editing techniques that Fahrenkrug argues do not require FDA approval. The agency regulates animals that are engineered using a “recombinant DNA construct”, but his animals are modified by injecting protein and RNA into embryos. “It’s a treatment, not a transgene,” he says. The FDA has yet to announce how it will view such animals, but Fahrenkrug takes approval of the salmon as a sign that the agency is willing to allow them onto the market. “I’m feeling optimistic now,” he says.
News Article | January 20, 2016
"A week after the federal government released its latest recommendations for healthful eating, the 2015-20 Dietary Guidelines have touched off a food fight. Acknowledging that the "scientific integrity" of the drafting process has been called into question, Congress has asked the National Academies of Science to review "whether balanced nutrition information is reaching the public," and set aside $1 million for the effort. Meanwhile, nutritionists, public health specialists and experts in preventive health are vying to critique the government document, fill in its gaps and "spin" the guidelines to support their interests." "Why Mainstream Researchers Think the U.S. Dietary Guidelines Lack Scientific Rigor" (Washington Post) Editorial: "Healthy Guidelines: Despite Its Critics, The New Food Plan Is Sensible" (Pittsburgh Post-Gazette) "What’s New in the Dietary Guidelines" (New York Times/Well) "New Dietary Guidelines Take Bite Out Of Sugar, Salt" (Columbian) Opinion: "The New US Dietary Guidelines Miss A Huge, Crucial Issue" (MSNBC/ Dr. Neal Barnard) "Who’s Mad About The New Dietary Guidelines? Cancer Experts, For One" (MSNBC) Press Release: "New "Dietary Guidelines" Recommends Eating Less Sugar & Meat" (Center for Science in the Public Interest) "New Dietary Guidelines remove restriction on total fat and set limit for added sugars but censor conclusions of the scientific advisory committee" (Harvard T.H. Chan School of Public Health)
Kobylewski S.,University of California at Los Angeles |
Jacobson M.F.,Center for Science in the Public Interest
International Journal of Occupational and Environmental Health | Year: 2012
Background: Food dyes, synthesized originally from coal tar and now petroleum, have long been controversial because of safety concerns. Many dyes have been banned because of their adverse effects on laboratory animals or inadequate testing. Conclusions: This review finds that all of the nine currently US-approved dyes raise health concerns of varying degrees. Red 3 causes cancer in animals, and there is evidence that several other dyes also are carcinogenic. Three dyes (Red 40, Yellow 5, and Yellow 6) have been found to be contaminated with benzidine or other carcinogens. At least four dyes (Blue 1, Red 40, Yellow 5, and Yellow 6) cause hypersensitivity reactions. Numerous microbiological and rodent studies of Yellow 5 were positive for genotoxicity. Toxicity tests on two dyes (Citrus Red 2 and Orange B) also suggest safety concerns, but Citrus Red 2 is used at low levels and only on some Florida oranges and Orange B has not been used for several years. The inadequacy of much of the testing and the evidence for carcinogenicity, genotoxicity, and hypersensitivity, coupled with the fact that dyes do not improve the safety or nutritional quality of foods, indicates that all of the currently used dyes should be removed from the food supply and replaced, if at all, by safer colorings. It is recommended that regulatory authorities require better and independent toxicity testing, exercise greater caution regarding continued approval of these dyes, and in the future approve only well-tested, safe dyes. © W. S. Maney & Son Ltd 2012.
Wootan M.G.,Center for Science in the Public Interest
Childhood Obesity | Year: 2012
Helping families make healthier choices when eating out is important because eating out is a growing and significant part of Americans' diets and eating out is associated with obesity. Although a number of restaurants have announced improvements recently, many restaurant children's meals remain high in calories, saturated fat, and sodium, and default options are often fries and sugary drinks. Behavioral economic interventions that make default options healthy make healthy choices easier and mean that individuals must actively work to engage in less desirable behaviors. Providing healthier default options for children's meals supports parents by reducing barriers to feeding their children healthfully. This article outlines a number of ways to help families make the healthy choice the easy and the default choice for children when eating out. © 2012 Mary Ann Liebert, Inc.
Center For Science In The Public Interest | Date: 2016-06-22
News Article | December 25, 2016
Taxes on sugary drinks had a banner year in the US, with six new laws passed across the US. But advocates for the preventive health measures are warning that the Trump administration could threaten or even reverse momentum. “I think there is going to be some battles to be fought to maintain ground and not lose ground,” said David Goldberg, a spokesperson for Healthy Food America (HFA), a key supporter of these taxes. In October, the World Health Organization urged all nations to consider a sugary drink tax to curb obesity, cut health care costs and increase revenue for health services. WHO has found that a 20% increase in price led to fewer people consuming sugary drinks. It said taxes would have the greatest positive impact on the young and people with low incomes. Sugary drink tax success in the US has followed momentum internationally. Several countries have introduced the taxes in recent years, including Mexico, which introduced the tax in January 2014 and the UK, which is set to introduce its sugary drink tax in 2018. When 2016 started, Berkeley, California was the only US jurisdiction with a sugary drink tax, which passed in 2014. But this year, Americans voted by referendum to institute the taxes in four cities, and city officials passed taxes in two other metropolitan areas: Philadelphia and Cook County, Illinois – a 5.2 million person jurisdiction that includes Chicago. Now, sugary drink tax supporters see the US federal government as a threat to these developments. President-elect Donald Trump campaigned against lobbyists, but his transition team included Michael Torrey, a lobbyist who runs a firm that helps the main soda lobby, the American Beverage Association. Torrey was tasked with helping set up the Department of Agriculture team, according to the New York Times. And in early December, Trump named fast food executive Andy Puzder as head of the labor department. “We just have to be vigilant and try to protect gains that have been made in recent years,” Goldberg said. “But meanwhile, regardless of what the lobbyists are doing at the federal level, we think local communities will keep making progress”. New York University nutrition professor Marion Nestle, author of Soda Politics: Taking on Big Soda (and Winning), said progress on soda taxes has been outstanding, but it was difficult to predict how Trump and a Republican-dominated Congress would act towards public health initiatives. “Nobody seems very interested in public health in the group that’s coming in, but we have to wait and see – it doesn’t look promising,” she said. “If I were Coca-Cola, I’d be in Congress right now”. The beverage industry, for its part, said the success of sugar tax laws has been exaggerated. “The pro-tax advocates are going to areas that are more predisposed to taxes and I just don’t see taxes sweeping the middle of the country and people in the middle of the country wanting more government intervention,” said Lauren Kane, an American Beverage Association spokeswoman. She noted that the taxes won by popular vote in some of the healthiest cities in the country: Boulder, Colorado and San Francisco. But that skepticism has not stopped the industry from spending millions of dollars to combat these local laws. The 2016 sugar tax votes were some of the most expensive ballot measures nationwide, with the American Beverage Association, spending $38m to try and defeat the measures. Pro-sugar tax campaigns, meanwhile, were backed by billionaire donors such as Laura and John Arnold, whose foundation donates to HFA, and former New York City mayor Michael Bloomberg, who donated nearly $20m to efforts in California’s Bay Area. The taxes are also being introduced after decades of falling soda sales as consumers move away from sugary drinks in favor of healthier options. “The reality is that they [the beverage industry] are facing a public that understands the increased health risks from sugar drinks and they are facing local policy makers and local community advocates who know what their communities need,” said Jim O’Hara, the director of health promotion policy at the Center for Science in the Public Interest, a non-profit that supports sugar taxes. O’Hara said local needs would outweigh national political debates about these local health laws. “Mr Trump will be the president of the United States,” O’Hara said. “He’s not going to be the mayor or governor in cities or states across the county”.
News Article | April 21, 2016
The debate over genetically modified foods is about to get a lot more heated in Washington, D.C. DuPont Pioneer’s new waxy corn hybrid and a Penn State plant scientist’s “anti-browning” white button mushroom are the latest additions to a fast-growing pile of new genetically engineered crops that have so far avoided any government regulation. New gene-editing techniques like CRISPR are making this possible, and they are underscoring the fact that the regulatory system hasn’t kept up with the breakneck pace of biotechnological innovation. It’s not for lack of trying. Last summer, the White House called on the U.S. Department of Agriculture, the Environmental Protection Agency, and the Food and Drug Administration to “modernize” the federal system for regulating “products of biotechnology,” including crops. In line with that, in February the USDA informed the public of its intent to change its system for regulating genetically engineered organisms. The USDA does the bulk of the regulating when it comes to genetically engineered crops, under a law called the Plant Protection Act, to protect other crops and the environment from “plant pests.” Specifically, the agency regulates a crop if it has been genetically engineered using a plant pest, meaning that the donor, the recipient, or the vector for delivering the new gene qualifies as a plant pest. That made a lot more sense for the previous generation of genetically engineered crops, commonly called GMOs. Most were made using a soil bacterium to deliver a new gene, were modified with a gene taken from a bacterium, or both. That triggered the “plant pest” regulatory mechanism. Newer techniques like CRISPR can modify the genome without inserting a new gene and don't rely on plant pests, so they don’t trigger that mechanism. So far, the agency has determined that more than 30 genetically engineered crops are not subject to its regulations. The fact that genetically engineered crops are escaping regulation only because they don't meet the legal definition of a plant pest means the system is not working, says Gregory Jaffe, director of biotechnology for the Center for Science in the Public Interest. “It’s not a science-based determination.” Just how the USDA’s system might change is hard to predict. In February, the agency proposed several hypothetical approaches, which ranged from doing nothing to substantially increasing the USDA’s ability to review and regulate genetically engineered crops. In the near future the agency will review public comments on those proposals. It will also consider the results of a newly launched study by the National Academies of Sciences, Engineering, and Medicine. The scientists, policy experts, and industry representatives in the study group are tasked with helping the USDA, FDA, and EPA prepare for the future by describing the scientific and technological advances likely to emerge in the next five to 10 years. They are also charged with determining whether future genetically engineered organisms could pose “different types of risks to existing products and organisms.” Bernice Slutsky, senior vice president of domestic and international policy at the American Seed Trade Association, says regulators should be careful not to use the term “gene editing” too loosely. These techniques can be used in many different ways, and lumping the applications together “doesn’t provide enough nuance in terms of the ultimate product,” she argues, which could lead to unnecessary overregulation. For example, CRISPR gives developers the ability to make very small, precise edits to the genome, such as the deletion of a single gene. In many cases the outcome is no different from one achieved using traditional techniques that rely on chemicals or radiation to induce mutations, says Slutsky. Crops developed that way are not regulated. “If you can get to the same product end point through traditional breeding as you can through a gene-editing method, why would you treat them differently from a regulatory perspective?” But it could take years to finalize new regulations, and the uncertainty could stifle innovation. “A lot of developers are holding back until they know what the rules are,” says Slutsky. In the meantime, it’s likely that the gene-edited crops that are developed will continue to earn unregulated status—and some may even find their way to grocery stores.
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 | September 21, 2016
Sugar has become the nutritional villain du jour, but just how bad is our addiction? The answer is tricky. Philadelphia recently passed a tax on sugary drinks, several other places have proposed them, and the government this year recommended we limit our intake of added sugars to 10 percent of daily calories, underscoring how significant elected officials believe the problem is. But while determining exactly how much sugar we're consuming is a complicated business — government figures are estimates— the data and industry trends indicate we've actually made progress in cutting back. On average, Americans' total consumption of caloric sweeteners like refined cane sugar and high-fructose corn syrup is down 15 percent from its peak in 1999, according to government data. That's when we consumed an average of 111 grams of sugar a day (423 calories). After plateauing in recent years, consumption was down to 94 grams a day (358 calories) last year, according to the U.S. Department of Agriculture, which calculates the figures by estimating how much of the caloric sweeteners produced are never eaten. But that level is still higher than the 87 grams Americans consumed on average in 1970. A major factor for the drop appears to be the decline in soda consumption, as the high-fructose corn syrup used to sweeten drinks like Sprite and Mountain Dew has been on the decline. Thomas Farley, the health commissioner in Philadelphia, said it could take many years before the positive effects from the reductions in soda consumption to turn up in health data. But he also noted that factors like the growth in snacking, the availability of food in more places, and oversized restaurant dishes can fuel obesity. "Sugar is a problem, but sugar is not the only problem," Farley said. And though it's lower, sweetener consumption of 94 grams a day is still the equivalent of roughly two and half cans of Coke. That far exceeds the government's recommendation to limit added sugar to around 50 grams a day (200 calories) for someone on a 2,000-calorie diet. Notably, a per capita consumption figure doesn't account for the wide disparities in intake among individuals. The way the USDA estimates sweetener consumption also means the specific figure could be higher or lower. The agency changed its methodology in 2012, which meant a sharp reduction in how much sugar it said we consume. Emails obtained by the Center for Science in the Public Interest, which supports soda taxes, show that a sugar industry group wanted the change and hoped for "as low a per capita sweetener consumption estimate as possible." There's always room for "improvement and refinement" in making food consumption estimates, said Michael McConnell, an agriculture economist who specializes in sweeteners at the USDA. But he said the change in methodology was applied retroactively, so any trend the numbers show would still be consistent. Even if the numbers are inexact, others agree the downward trajectory in sweeteners makes sense. That's because soda consumption started falling around the same time, and is down 24 percent since 1998, according to industry tracker Beverage Digest. Michael Jacobson, executive director of the CSPI, thinks it's a major factor — and perhaps the entire reason — for the drop in sweetener consumption. The American Beverage Association, the trade group for Coke and Pepsi, says soda isn't the driver of obesity rates, since those levels have climbed as soda drinking has declined. Gary Taubes, a science author, believes the influx of sweeteners and refined carbohydrates in diets has likely fueled obesity, but notes there's ambiguity in the evidence. And Cristin Kearns, a former dentist who has been uncovering documents showing the sugar industry's influence on nutrition science, noted that "manufacturers are getting crafty" about the types of sweeteners they use, such as juice concentrate, meaning they might not show up in consumption figures. As sugar comes under fire, food companies are using sophisticated new methods to reduce sweeteners without sacrificing sweetness. Consider the use of "sweet taste boosters" that amplify smaller amounts of sweeteners. The ingredients are listed as "artificial flavors" on packages, according to Senomyx, a California company that makes them. Earlier this year, MycoTechnology began making a "bitter blocker" that reduces the need for sweeteners that mask bitterness. The Colorado company says it is made from a mushroom extract and can be listed as a "natural flavor." Some companies have also switched back to "real sugar" to give their products a more wholesome image, even though there may be no difference in calories. While the overall decline in sweeteners reflects the drop in high-fructose corn syrup, the consumption of refined sugar has actually edged up in recent years. In that small regard, sugar is enjoying a revival.
News Article | April 29, 2016
Five U.S. senators are urging FDA to ban retail sales and marketing of bulk powdered caffeine after the 2014 deaths of two men who consumed too much of the substance. Last week, Sens. Sherrod Brown (D-Ohio), Richard Blumenthal (D-Conn.), Dick Durbin (D-Ill.), Ed Markey (D-Mass.), and Chuck Schumer (D-N.Y.) joined the consumer group Center for Science in the Public Interest (CSPI) and families of the men who overdosed to raise awareness about the dangers of . . .