DEDHAM, Mass. — If you take a look around your kitchen, you’ll likely see a variety of foods you love to eat. Many of those foods probably include chemicals that are banned in other countries due to health concerns.
Some companies even make two versions of their products—one without these additives that are sold in Europe and another with additives that are sold in the United States. Scott Faber works with the Environmental Working Group (EWG) to track the use of food additives worldwide. “Many of the chemicals that are in your food, if they have been reviewed by the FDA, have not been reviewed for 40 or 50 years,” Faber said “As you can imagine, there’s been a lot of scientific developments and changes in how we use these chemicals.” The Federal Drug Administration has not reviewed those ingredients because, in 1966, it deemed hundreds of additives as ‘Generally Recognized As Safe’ or GRAS. The “GRAS list” keeps growing and now there are about a thousand. The EWG highlighted the most common additives on the GRAS list that are banned in other countries. Brominated vegetable oil
When asked about this report, the FDA sent the statement below: “Regulatory authorities across the globe have different legal authorities and regulatory programs. It is not uncommon for a substance to be approved in one jurisdiction but not in another. For example, there are color additives that are authorized for use in Europe and elsewhere but are not authorized in the U.S. We also note that other international regulatory bodies including the United Kingdom’s FSA, Health Canada, and Food Standards Australia New Zealand (FSANZ) have not agreed with the European Union assessment regarding titanium dioxide. Review of titanium dioxide as a food additive (foodstandards.gov.au) The FDA evaluates and regulates ingredients added to food to ensure that the authorized use of these ingredients is safe. Specifically, food additives and color additives require pre-market review and approval by the FDA before they can be added to food. To obtain this authorization, a manufacturer is required to supply the FDA with evidence that establishes each food or color additive is safe under its intended conditions of use. In the case of food or color additives, manufacturers submit data and information to the FDA as a petition requesting approval of the ingredient for the specific intended use(s). The submitted information includes data pertaining to the identity of the substance, its method of manufacturing, purity, intended food categories, an amount expected to be consumed (dietary exposure), and laboratory studies supporting safety. The FDA evaluates the petition and other existing data and information to determine if the data available demonstrate that the substance is safe under the intended conditions of use. If the FDA determines that the intended use of the additive is safe, the FDA publishes a regulation authorizing its use as a food additive or color additive. The definition of food additive in the Federal Food, Drug, and Cosmetic Act includes a provision for the use of substances that are Generally Recognized as Safe (GRAS) (there is no such provision for color additive uses). For the use of a substance to be considered GRAS, all data necessary to establish safety must be publicly available and its safe use must be generally recognized by qualified experts. In addition, GRAS users must meet the same safety standard as for food additives, a reasonable certainty of no harm under the conditions of its intended use, and have the same quantity and quality of information that would support the safety of a food additive. The FDA has established a GRAS notification program to help ensure that these substances are safe under their intended use and to help the industry meet its responsibility for ensuring the GRAS status of substances they intend to use in food. Food manufacturers that have concluded that the intended uses of a substance meet the GRAS standards can submit a notice and receive a response letter from FDA on the manufacturer’s safety conclusion. The FDA strongly encourages food manufacturers to contact the agency and follow the available procedures for our oversight of GRAS conclusions by participating in our GRAS Notification Program. The FDA has evaluated more than 1,000 GRAS Notices since the beginning of the GRAS Notification Program in 1997. We may determine that the use of a substance is not generally recognized as safe and require FDA approval as a food additive. In addition to our GRAS Notification Program, we also proactively support efforts to aid the industry in complying with the law (the FD&C Act). For example, we recently published a final guidance document (Guidance for Industry: Best Practices for Convening a GRAS Panel | FDA). This document provides guidance to industry on best practices to follow when convening a panel of experts to evaluate whether a substance is “generally recognized as safe” (GRAS) under the conditions of its intended use and addresses topics such as identifying appropriate experts, reducing the risk of bias, and how to ensure that all data and information provided to the panel are publicly available. We also have issued numerous other guidance documents to clarify the regulations for GRAS. Although the FDA monitors, evaluates, and regulates ingredients added to food to ensure that the authorized use of these ingredients is safe, it’s important to underscore that food manufacturers are responsible for marketing safe foods. The food industry has a legal responsibility to ensure the safety of the ingredients they use in foods before they go to market. The safety of food additives must be supported by science that demonstrates its use meets the FDA’s safety standards. The same safety standards and required evidence apply to uses of ingredients that are considered generally recognized as safe. The FDA assists the food industry to meet its legal obligation to market safe foods through our regulations, guidance documents, and regulatory programs. When a substance added to food is not GRAS (and is not otherwise excepted from the definition of a “food additive”) and is not approved as a food additive under the conditions of its intended use, the FDA can take various actions, including issuing a warning letter (which we make public on our web site, fda.gov) to companies that manufacture or distribute the food additive and/or food containing the food additive; issuing a public alert; and taking enforcement action to stop distribution of the food substance and foods containing it on the grounds that such foods are or contain an unlawful food additive. Titanium dioxide is regulated by the FDA as a color additive. The FDA has several authorizing color additive regulations for titanium dioxide, for use in food, drugs, cosmetics, and medical devices. The regulations are here: CFR – Code of Federal Regulations Title 21 (fda.gov), CFR – Code of Federal Regulations Title 21 (fda.gov), CFR - Code of Federal Regulations Title 21 (fda.gov), and here: CFR - Code of Federal Regulations Title 21 (fda.gov). The FDA is aware of recent actions taken by the European Union regarding use of titanium dioxide as a color additive. We note that other international regulatory bodies including the United Kingdom’s FSA, Health Canada, and FSANZ have not agreed with the European Union assessment. Review of titanium dioxide as a food additive (foodstandards.gov.au) Potassium bromate has been used as a bread dough conditioner since 1916, as permitted by the FDA’s standards of identity for bromated flour used for various types of bread, rolls, and buns. When food manufacturers use potassium bromate properly, potassium bromate converts to harmless potassium bromide in the finished food product. The FDA has worked with the American Baker’s Association (ABA) to help the industry improve baking technology and testing so that the ingredient is used in a way that results in no or minimal detectable residual bromate. ABA has indicated that normal control measures can ensure that bromate residues are well below 20 ppm. In addition, we note that recent label surveys indicate that the ingredient is no longer widely used by the baking industry. Brominated vegetable oil (BVO) is regulated as a food additive. Based on early toxicological data, the FDA took action in 1970 to limit consumer exposure by removing BVO from the list of codified GRAS substances and allowing for only one use in food—as a stabilizer for flavoring oils in fruit-flavored beverages at levels not to exceed 15 parts per million in the finished beverage (CFR - Code of Federal Regulations Title 21 (fda.gov)). For more information, see Brominated Vegetable Oil (BVO) | FDA. Propylparaben is also known as propyl p-hydroxybenzoate. Propylparaben is regulated as a food additive for use as a flavoring agent (CFR - Code of Federal Regulations Title 21 (fda.gov)) and as a substance affirmed as generally recognized as safe for use as an antimicrobial agent (CFR - Code of Federal Regulations Title 21 (fda.gov)). We also make regulatory information about these substances available to the public in our inventories of food ingredients in the U.S. food supply: Food Ingredient and Packaging Inventories | FDA, including the public Search Food Ingredient and Packaging Inventories (fda.gov).” https://www.boston25news.com/news/local/youd-be-surprised-groceries-banned-overseas-health-concerns-still-us-store-shelves/H6SPTXG3CFGOHJKSOV3HGVDEHE/ In January 2008, the U.S. Food and Drug Administration (FDA) approved the sale of cloned animals and their offspring for food, despite fierce opposition from animal welfare and consumer advocacy groups, environmental organizations, some members of Congress, and many consumers. “Our evaluation is that the food from cloned animals is as safe as the food we eat every day,” said Stephen Sundlof, the FDA’s chief of veterinary medicine. Meanwhile, the U.S. Department of Agriculture has asked that producers withhold cloned animals, but not their offspring, from the food supply while farmers, processors, grocery stores and restaurants decide how they will respond to the FDA’s landmark decision. Unsurprisingly, industry groups also argue that beef and milk from cloned animals is safe to consume. They cite a 2005 University of Connecticut study, which concluded that beef and milk from cloned cows did not pose any health or safety threats to people consuming it. But critics say that the oft-cited single study was far too limited to yield any meaningful conclusions: Milk and beef was taken from just six cloned animals, and the study did not take into account whether clones were more susceptible to infection or other microbial problems, as many scientists suspect. Other researchers have noted severe deformities in many cloned animals, as well as a higher incidence of reproductive, immune and other health problems. The Washington, DC-based Center for Food Safety, in a petition it filed in late 2006, declared: “The available science shows that cloning presents serious food safety risks, animal welfare concerns and unresolved ethical issues that require strict oversight.” The group announced on September 2, 2008 that 20 leading U.S. food producers—including Kraft Foods, General Mills, Gerber/Nestle, Campbell’s Soup and Ben and Jerry’s—will not use cloned animals in their products. “The move by these companies represents a growing industry trend of responding to consumer demand for better food safety, environmental and animal welfare standards,” the group said in making the announcement. Given the FDA’s green light, consumers’ only hope of avoiding cloned animal products may be to appeal to businesses directly not to peddle such items. The Pennsylvania-based American Anti-Vivisection Society, which opposes all forms of animal research and testing, has mounted a campaign to urge McDonald’s to forego cloned animals in its 30,000 restaurants worldwide. CONTACTS: U.S. Food & Drug Administration, www.fda.gov; Center for Food Safety, www.centerforfoodsafety.org; American Anti-Vivisection Society, www.aavs.org. GOT AN ENVIRONMENTAL QUESTION? Send it to: EarthTalk, c/o E/The Environmental Magazine, P.O. Box 5098, Westport, CT 06881; submit it at: www.emagazine.com/earthtalk/thisweek/, or e-mail: [email protected]. Read past columns at: www.emagazine.com/earthtalk/archives.php. https://www.scientificamerican.com/article/are-we-eating-cloned-meat/#:~:text=In%20January%202008%2C%20the%20U.S.,of%20Congress%2C%20and%20many%20consumers. FDA: People Can Eat These Gene-Edited PigsThe United States Food and Drug Administration has authorized gene-edited pigs entrance into the food chain for human consumption—as German-style sausages. Gene-editing can make changes in an organism’s DNA that could occur in nature or through selective breeding but would take much longer without a tool like CRISPR. The FDA authorization is investigational, and limited to these particular pigs, but shows that gene-editing livestock to quickly produce desirable traits for improved food production is a viable strategy for helping feed the planet’s growing population. “It’s important for a university to set the precedent by working with federal regulators to get these animals introduced into the food supply,” says Jon Oatley, a professor in the School of Molecular Biosciences in Washington State University’s College of Veterinary Medicine. “If we don’t go through that process, all of the research we’re doing is for naught because it will never make it out into the public.” Oatley uses the gene-editing tool CRISPR to improve genetic traits in livestock and is working toward an FDA approval for a line of gene-edited pigs. He undertook the investigational food use authorization process for five gene-edited pigs to demonstrate that food made from the animals is safe to eat and that it is possible for an academic institution to achieve this type of FDA authorization. The two-year-old pigs were processed at the university’s Meat Lab, and the US Department of Agriculture inspected the meat, as it does with all meat products. Working with the Meat Lab, meat scientist Blake Foraker made some of the pork into sausages, which will be used in catering services that raise travel funds for the student members of the university’s Meat Judging team. The pigs were originally gene-edited in a way that would enable researchers to use them to sire offspring with traits from another male pig. Known as surrogate sires, this technology first gene-edits male animals to be sterile by knocking out a gene called NANOS2 that is specific to male fertility. These animals can then be implanted with another male’s stem cells that create sperm with that male’s desired traits to be passed on to the next generation. The surrogate sires’ progeny, which are themselves not gene-edited, have not yet been reviewed by the FDA for possible inclusion in the food chain. Securing the investigational approval for these five pigs required clearing a number of hurdles. The FDA waives some fees for nonprofits like universities, but by the time the process was completed, Oatley’s team had spent two years and approximately $200,000 collecting data for this authorization. “The original intent in making these animals was to try to improve the way that we feed people,” he says. “And we can’t do that unless we can work with the FDA system to get these animals actually into the food chain.” Only one other organization, a company by the name of Acceligen, has had a gene-edited animal receive the FDA ok to enter the food supply. In 2020, the FDA made a low-risk determination for products made from “Slick-Haired Cattle,” which are gene-edited to have coats that increase the animals’ resilience to higher temperatures. Other companies have had genetically modified animals approved by the FDA, but the approach was transgenic which is a different technology involving inserting DNA from outside species into the genome of an organism. Gene-editing is a modern, cutting-edge technology that works only within a species’ DNA and can make changes that could come about naturally or through traditional breeding practices. The public often holds many misconceptions about gene-editing, Oatley says. He hopes this example will help dispel misinformation and improve perceptions of this technology. “There’s a trust that comes with university-based research,” he says. “We just want to make sure the research is valid, and the animals we produce are healthy.” https://www.nextgov.com/ideas/2023/05/fda-people-can-eat-these-gene-edited-pigs/386064/ BY ALEKS PHILLIPS A barge carrying 1,400 tons of methanol, a toxic substance, is among those to have crashed on the Ohio River near Louisville, Kentucky, on Tuesday and is partially submerged. The Louisville Metropolitan Emergency Services (LMES) said that shortly after 2 a.m. ET a vessel towing 11 barges made contact with a "stationary structure" at the entrance to the Portland Canal, to the west of Louisville, near the McAlpine Dam. It comes just weeks after a toxic plume traveled down the major U.S. waterway from the site of a train derailment near East Palestine, on the border between Ohio and Pennsylvania, prompting measures to prevent contamination of the drinking water that is supplied to around 5 million people from the river. The LMES stressed in a statement that there is "currently zero evidence of a tank breach or any leaks" and that "air and water monitoring resources are in place." "Safety is the top concern—safety of the public and first responder personnel," it added. "There is currently no impact to Louisville Water's water intake or water quality." The Kentucky Energy and Environment Cabinet (EEC) said the barge carrying methanol in its three cargo holds was "lodged" in the lower McAlpine Dam—which was built along with a series of locks to allow boats to circumvent the Falls of the Ohio—and that the nearest municipal water intake was downstream in Henderson, Kentucky. Musk’s New Texas Neighbors Alarmed by His Huge Development PlansBASTROP, TEXAS--Elon Musk’s companies are opening facilities across the country that come with promises of skilled jobs and economic growth. But some residents of this mostly rural area near Austin are watching with alarm as farmland turns into industrial development. Mr. Musk’s tunneling venture, the Boring Company, and space-transportation company known as SpaceX, are constructing massive buildings and digging tunnels on more than 200 acres of unincorporated land along the Colorado River. The billionaire’s ambitions there also include a company town, The Wall Street Journal has reported. At a heated public meeting Tuesday night—the first since the Musk companies arrived here in early 2021—dozens of Bastrop County residents objected to the companies’ plan to build their own wastewater plant and then spray the treated water on fields or discharge it into the river. Some pointed to environmental violations they have already racked up as cause for more evaluation. Harold “Skip” Connett, who runs Green Gate Farms, an organic farm near the Boring and SpaceX properties, said at the meeting that those developments have helped transform a “beautiful agritourism recreational center into an industrial site. And it was never meant to be that.” https://www.wsj.com/articles/musks-new-texas-neighbors-alarmed-by-his-huge-development-plans-148a60c8 The TikTok Hearing: Exploring the Implications and Consequences of Social Media ModerationU.S. lawmakers grilled the CEO of TikTok over data security and harmful content Thursday, responding skeptically during a tense committee hearing to his assurances that the hugely popular video-sharing app prioritizes user safety and should not be banned. Shou Zi Chew's testimony came at a crucial time for the company, which has acquired 150 million American users but is under increasing pressure from U.S. officials. TikTok and its parent company ByteDance have been swept up in a wider geopolitical battle between Beijing and Washington over trade and technology. In a rare bipartisan effort to reign in the power of a major social media platform, Republican and Democratic lawmakers pressed Chew on a host of topics, ranging from TikTok’s content moderation practices, how the company plans to secure American data from Beijing, and its spying on journalists. “Mr. Chew, you are here because the American people need the truth about the threat TikTok poses to our national and personal security,” Committee Chair Cathy McMorris Rodgers, a Republican, said in her opening statement. "TikTok has repeatedly chosen a path for more control, more surveillance and more manipulation.” Chew, a 40-year-old Singapore native, told the House Committee on Energy and Commerce that TikTok prioritizes the safety of its young users and denied allegations that it's a national security risk. He reiterated the company’s plan to protect U.S. user data by storing all such information on servers maintained and owned by the software giant Oracle. “Let me state this unequivocally: ByteDance is not an agent of China or any other country,” Chew said. On Wednesday, the company sent dozens of popular TikTokers to Capitol Hill to lobby lawmakers to preserve the platform. It has also been putting up ads all over Washington that promise to secure users' data and privacy, and create a safe platform for its young users. Major Alcohol Industry Association Calls For Federal Marijuana Legalization, Recommending Regulatory FrameworkA major alcohol industry association is officially backing federal marijuana legalization, sending a letter to congressional leadership on Wednesday that implores lawmakers to “regulate adult-use cannabis at the federal level.” The Wine & Spirits Wholesalers of America (WSWA) said that “the current conflict between state and federal law is not only causing adverse consequences for consumers and non-consumers of cannabis but will also have long-term public health and safety costs that are too great to ignore.” The association made two main points in its letter: 1) the current system for the regulation of alcohol “serves as a strong model” for cannabis and 2) a “piecemeal” approach to marijuana reform is untenable, so lawmakers should “comprehensively” address the issue. “The fact is cannabis legalization at the state level is here to stay, as evidenced by nearly a decade of new legalization efforts and no meaningful effort to undo them. Rather, the states that have legalized are expanding their markets and even discussing ways to begin interstate commerce of the product. Yet they receive no support from the federal government in determining how to ensure that products are safe or that the market is fair—especially as that market becomes increasingly national in scope.” The letter, which was noted earlier by Politico, also emphasizes that states should be able to “maintain the flexibility to legalize—or not legalize—cannabis within their borders.” “Addressing cannabis federally in a piecemeal manner amounts to de facto federal legalization without protecting consumers and non-consumers alike,” WSWA wrote in the letter to Senate Majority Leader Chuck Schumer (D-NY), House Speaker Kevin McCarthy (R-CA), Senate Minority Leader Mitch McConnell (R-KY) and House Minority Leader Hakeem Jeffries (D-NY). “The current fragmentary approach widens the door for the negative impacts of cannabis legalization without additional safeguards for public health and public safety. By not taking action, the federal government is also losing out on tax revenue.” It also makes a point to endorse the idea of having the federal government open the doors to interstate cannabis commerce—a position widely embraced by industry stakeholders and lawmakers in a growing number of states. WSWA pointed to a policy brief it first drafted in 2021 that lays out regulatory priorities that the association says lawmakers should keep in mind as members work to replace prohibition with a legalization framework. The brief says that policymakers should draw from the experience of alcohol regulations to develop a model for marijuana that promotes industry competition, innovation and public safety. The transition from alcohol prohibition to legalization represents “an American success story” that should be replicated with cannabis, it said. Again, the association isn’t suggesting that federal regulations should totally supplant those that have been established in states across the U.S., but some level of regulatory oversight and taxation could support those programs and help normalize the cannabis sector. WSWA detailed four key principles for federal oversight of an adult-use marijuana supply chain: 1. The federal permitting of cannabis producers, importers, testing facilities and distributors. The association said states should manage licensing for marijuana retailers, but it recommended that the federal government require permits for cannabis producers, importers, testing facilities and distributors through the Department of Treasury’s Alcohol and Tobacco Tax and Trade Bureau (TTB). 2. The approval and regulation of cannabis products. New cannabis products should be subject to pre-market approval and federal registration, also through TTB, the association said. That would support existing quality control policies that are in place at the state level. A standardized label should be included on all marijuana items, too. They should feature information, at a minimum, about the product name, THC potency, net content, producer name and address, a government health warning and the country of origin (for imports). 3. The efficient and effective collection of federal excise tax. WSWA advised that a federal excise tax should be imposed for cannabis products at the producer or importer level, and it should be based on potency just as beverages are taxed based on alcohol concentration. The taxes should be payable to TTB on a semimonthly basis. 4. Effective measures to ensure public safety. With respect to public safety, the association focused on deterring impaired driving, and it said that lawmakers should prioritize collaborative partnerships with law enforcement and researchers to develop technology that can identify active impairment from cannabis while also funding training for drug recognition experts on the roads. WSWA, which came out in support of states rights to legalize cannabis in 2018, ended its policy brief by explaining why it’s taking this step to advise on federal reform. Since the end of alcohol prohibition, a “safe and economically vibrant marketplace has developed—one that serves the dual needs of regulators and consumers,” it said. “While individual regulations have been modified over time, the basic federal regulatory structure of permitting and tax collection has stood the test of time,” WSWA’s paper says. “As policymakers consider the future of adult-use cannabis, we believe it is important to share the learnings of our industry. America’s wine and spirits wholesalers are a proud part of this system and believe that the principles outlined here can be extended to a national adult-use cannabis system.” The House has twice passed bills to federally legalize and regulate marijuana, but comprehensive reform hasn’t advanced in the Senate, despite leadership having introduced much-anticipated legislation to end prohibition last session. A key difference between that bill from Senate Majority Leader Chuck Schumer (D-NY) and the alcohol association concerns the distribution of regulatory responsibility. Advocates have worried about the Senate measure’s deference to the Food and Drug Administration (FDA), and it’s likely that WSWA’s position on having basic oversight managed by TTB would prove more acceptable to many stakeholders. An earlier WSWA press release on the policy brief contains strong language about the need to lower barriers to entry for those who’ve been “victimized by the federal government’s failed war on drugs,” as well as its support for “efforts of experts who advocate for other social equity measures to alleviate the damage done to these communities.” However, the brief itself is light on recommendations to that end, simply including a note that people with “non-violent cannabis-related offenses that occurred prior to federal legalization/descheduling” should not be disqualified from receiving federal permits to operate marijuana businesses. The proposal does not provide for any prioritization in permitting for people from communities damaged by the drug war. Legalization advocates say WSWA’s involvement could bolster efforts to get lawmakers to look more seriously at the issue. “It’s with a nervous excitement that we welcome WSWA into the lobbying efforts to end federal marijuana prohibition,” Justin Strekal, founder of BOWL PAC, told Marijuana Moment. “With WSWA’s footprint of members in nearly every state and congressional district, there is no better time than now to engage lawmakers both in D.C. and at home about the need to remove marijuana from the Controlled Substances Act and implement a regulatory structure that fosters an environment for small and medium-sized businesses.” But Strekal also said he would like to see more of an equity focus in the group’s recommendations. “Pointed policy suggestions regarding criminal justice reform that align with groups like the Marijuana Justice Coalition would be very welcome in their second draft,” he said. (Disclosure: Strekal supports Marijuana Moment’s work through a monthly pledge on Patreon.) After coming out in support of states’ rights to legalize cannabis in 2018, WSWA held a briefing on Capitol Hill to inform lawmakers and congressional staffers about its position. In 2021, the association also endorsed a Senate bill to allow hemp derivatives such as CBD to be used in consumable products like foods, drinks and dietary supplements. Google showed off its new chatbot. It immediately made a mistake. "Indulge in a slice of heaven with every bite of Paul's Cakes. This bakery has been serving up delectable treats for years, making them a fan favorite among cake enthusiasts. From rich and creamy cheesecakes to light and fluffy angel food cakes, Paul's Cakes has something for everyone. With a focus on using only the finest ingredients and traditional baking techniques, each cake is crafted to perfection. So whether you're celebrating a special occasion or just want to treat yourself, be sure to try Paul's Cakes for a taste experience you won't forget." Microsoft says it’s using conversational AI to create a new way to browse the web. Users will be able to chat to Bing like ChatGPT, asking questions and receiving answers in natural language.
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AuthorI'm Trill, Jack of all trades master of none Archives
May 2023
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