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Rockville, MD, United States

Jacob C.C.,National Center for Toxicological Research (NCTR) | Reimschuessel R.,Center for Veterinary Medicine | von Tungeln L.S.,National Center for Toxicological Research (NCTR) | Olson G.R.,Toxicologic Pathology Associates | And 4 more authors.
Toxicological Sciences | Year: 2011

The intentional adulteration of pet food with melamine and derivatives, including cyanuric acid, has been implicated in the kidney failure and death of a large number of cats and dogs in the United States. Although individually these compounds present low toxicity, coexposure can lead to the formation of melamine cyanurate crystals in the nephrons and eventual kidney failure. To determine the dose-response for nephrotoxicity upon coadministration of melamine and cyanuric acid, groups of male and female F344 rats (six animals per sex per group) were fed 0 (control), 7, 23, 69, 229, or 694 ppm of both melamine and cyanuric acid; 1388 ppm melamine; or 1388 ppm cyanuric acid in the diet for 7 days. No toxicity was observed in the rats exposed to the individual compounds, whereas anorexia and a statistically significant increase in blood urea nitrogen and serum creatinine levels was observed in the animals treated with 229 and 694 ppm melamine and cyanuric acid. The kidneys of these animals were grossly enlarged and pale yellow. Large numbers of crystalline structures deposited in the tubules were seen on sections in kidneys from all rats in these treatment groups. No significant changes were detected in the remaining treatment groups exposed to both melamine and cyanuric acid. In the melamine-only treatment group, 5 of 12 rats had scattered crystals present in renal tubules when examined by wet mount. These were not observed by histopathology. The observed adverse effect level (8.6 mg/kg bw [body weight]/day) and benchmark dose modeling data (8.4-10.9 mg/kg bw/day) determined in this study suggest that the tolerable daily intake values derived from studies conducted with melamine alone may underestimate the risk from coexposures to melamine and cyanuric acid. Published by Oxford University Press 2010. Source


News Article
Site: http://phys.org/biology-news/

Critics call it "frankenfish," but the Food and Drug Administration granted its approval on Thursday, saying the faster-growing salmon is safe to eat. It could be available in a couple of years. "There are no biologically relevant differences in the nutritional profile of AquAdvantage Salmon compared to that of other farm-raised Atlantic salmon," the agency said. The Obama administration had stalled in approving the salmon for more than five years amid consumer concerns about genetically modified foods. The fish grows twice as fast as normal salmon, so it reaches market size more quickly. AquAdvantage Salmon is engineered by the Massachusetts-based company AquaBounty. Ron Stotish, the company's CEO, said in a statement that the fish is a "game changer that brings healthy and nutritious food to consumers in an environmentally responsible manner without damaging the ocean and other marine habitats." AquaBounty said the fish could be on grocery store shelves in about two years, which is how long it takes the salmon to grow. Once the salmon reach stores, consumers may not know they are eating them. Because there are no material differences between an engineered and a normal salmon, the FDA says the law does not require the fish to be labeled as engineered. AquaBounty says that genetically modified salmon have the same flavor, texture, color and odor as the conventional fish. The FDA released separate wording that would set guidelines for retailers who do want to label the fish, along with additional guidance for voluntary labeling of genetically modified plant foods. Some retailers have said they won't sell the fish at all—retailers Whole Foods, Trader Joe's, Target and Kroger have all said they are not planning to sell AquAdvantage Salmon. Critics have pressured retailers to reject the salmon, which they have labeled "Frankenfish." They worry it could cause human allergies and the eventual decimation of the natural salmon population if it escapes into the wild. "There's no place on our dinner plates for genetically engineered fish," said Lisa Archer of the environmental advocacy group Friends of the Earth. "We will continue to work to ensure the market, from grocery retailers to restaurants, continues to listen to the majority of consumers that don't want to eat this poorly studied, unlabeled genetically engineered fish." Just hours after the announcement, another advocacy group, The Center for Food Safety, said it would sue FDA to block the approval. Alaska Sen. Lisa Murkowski, a Republican, has said the engineered salmon could harm her state's wild salmon industry. She took to the Senate floor to criticize the FDA shortly after the announcement, saying she was "spitting mad." She and other Alaska and Pacific Northwest lawmakers said they will swiftly push legislation to mandate labeling of the modified fish. The FDA said the salmon will be allowed to be raised only in land-based, contained hatchery tanks at two facilities in Canada and Panama, and that other facilities in the U.S. or elsewhere cannot breed or raise the salmon for human consumption. Those restrictions limit the amount of food the company can produce. The agency said that there are "multiple and redundant levels of physical barriers" in the facilities to prevent the escape of fish. The fish would be bred to be female and sterile, so if any did escape, they should not be able to breed. The salmon has an added growth hormone from the Pacific Chinook salmon that allows that fish to produce growth hormone all year long. Engineers have been able to keep the hormone active by using another gene from an eel-like fish called an ocean pout that acts like an "on" switch. Typical Atlantic salmon produce the growth hormone for only part of the year. Bernadette Dunham, director of the FDA's Center for Veterinary Medicine, said the agency "has thoroughly analyzed and evaluated the data and information" submitted by AquaBounty. To approve an engineered animal for human consumption, the agency reviews a company's data and must determine that the food is safe to eat, that the engineering is safe for the fish and that the company's claim—in this case, faster growth—is accurate. AquaBounty's Stotish said he is hopeful the fish will gain consumer acceptance as people learn more about it. "We think time and education and information may allow many of these folks to change their mind," he said of critics. Explore further: US mulls approval of genetically engineered salmon


News Article
Site: http://phys.org/biology-news/

The agency's Center for Veterinary Medicine released a preliminary finding of no significant impact for the field trial on a method that aims to reduce populations of the mosquito that spreads dengue, chikungunya and the Zika virus among humans. The trial is proposed by the British biotech firm Oxitec. The Florida Keys Mosquito Control District wants to test Oxitec's mosquitoes in a small neighborhood north of Key West. The FDA still needs to review public comments on Oxitec's proposal before deciding whether to approve that trial. Oxitec modifies Aedes aegypti mosquitoes with synthetic DNA to produce offspring that won't survive outside a lab. Oxitec has conducted similar tests in Panama, Brazil and the Cayman Islands. With or without the test, the district is looking for additional options to kill Aedes aegypti, which it considers a significant and expensive threat. In a statement, executive director Michael Doyle said the district needs to be proactive, and the trial will to determine how efficient Oxitec's mosquitoes are at suppressing the local Aedes population. "A small trial like this is designed to see if highly reducing the population is possible with this technology here in the Keys. If so, we will then look at larger trial areas," Doyle said. A residents' group called the Florida Keys Environmental Coalition wants the district to instead try infecting mosquitoes with a bacteria that curbs their ability to transmit disease, arguing that Oxitec's proposal is mostly marketing hype and won't be subject to adequate federal oversight. In an email Monday to The Associated Press, the coalition's executive director, Barry Wray, questioned the ongoing costs Oxitec's method might incur. "Oxitec has exploited the fear surrounding Zika very effectively," Wray wrote. "When you start looking at the quantity of mosquitoes they need to continuously provide, in order to keep problems under control, the numbers are astounding. So is the money required!" Doyle said the district is looking at several different technologies for eradicating Aedes mosquitoes, but those other methods take years to develop and Oxitec is furthest along. In a statement, Oxitec CEO Hadyn Parry said the company was pleased that the FDA agreed with their own findings. "We look forward to this proposed trial and the potential to protect people from Aedes aegypti and the diseases it spreads," Parry said. Anti-GMO activists have criticized Oxitec's trials, saying more proof is needed that stray female modified mosquitoes that leave the labs aren't spreading genetic material through bites or that there are no other environmental risks, such as opening areas to infestation by another disease-carrying mosquito species. Modified females are manually separated in Oxitec labs from the modified males, which do not bite and are released to mate with wild female mosquitoes. In its preliminary finding, the FDA said it was "highly unlikely" that humans or animals bitten by female modified mosquitoes would be exposed to synthetic genetic material, and any bites wouldn't be any different from bites made by a wild mosquito. It's also unlikely that suppressing the local Aedes population during the trial would open the area to an infestation of another disease-carrying species during that period, the FDA said. The FDA also found no significant risks that the modified mosquitoes would disperse well beyond the trial area, develop resistance to insecticides or persist in the environment. "Based on the data and information submitted in the draft (environmental assessment), other submissions from the sponsor, and scientific literature, FDA found that the probability of adverse impacts on human or other animal health is negligible or low," the finding said. A draft environmental assessment on Oxitec's proposal will be available for public comment for 30 days. The FDA will review those comments and may require further documentation from Oxitec before deciding whether to approve that trial. There is no deadline for that decision, so no modified mosquitoes will be released anytime soon. The Centers for Disease Control and Prevention and the Environmental Protection Agency also have reviewed the proposal along with the FDA.


Cerniglia C.E.,National Center for Toxicological Research (NCTR) | Pineiro S.A.,Center for Veterinary Medicine | Kotarski S.F.,Veterinary Medicine Research & Development
Drug Testing and Analysis | Year: 2016

The human gastrointestinal tract ecosystem consists of complex and diverse microbial communities that have now been collectively termed the intestinal microbiome. Recent scientific breakthroughs and research endeavours have increased our understanding of the important role the intestinal microbiome plays in human health and disease. The use of antimicrobial new animal drugs in food-producing animals may result in the presence of low levels of drug residues in edible foodstuffs. There is concern that antimicrobial new animal drugs in or on animal-derived food products at residue-level concentrations could disrupt the colonization barrier and/or modify the antimicrobial resistance profile of human intestinal bacteria. Therapeutic doses of antimicrobial drugs have been shown to promote shifts in the intestinal microbiome, and these disruptions promote the emergence of antimicrobial-resistant bacteria. To assess the effects of antimicrobial new animal drug residues in food on human intestinal bacteria, many national regulatory agencies and international committees follow a harmonized process, VICH GL36(R), which was issued by a trilateral organization of the European Union, the USA, and Japan called the International Cooperation on Harmonization of Technical Requirements for Veterinary Medicinal Products (VICH). The guidance describes a general approach currently used by national regulatory agencies and international committees to assess the effects of antimicrobial new animal drug residues in animal-derived food on human intestinal bacteria. The purpose of this review is to provide an overview of this current approach as part of the antimicrobial new animal drug approval process in participating countries, give insights on the microbiological endpoints used in this safety evaluation, and discuss the availability of new information. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd. Source


News Article
Site: http://www.biosciencetechnology.com/rss-feeds/all/rss.xml/all

What's for dinner? Before long, it may well be genetically modified salmon, the first such altered animal cleared for human consumption in the United States. Critics call it "frankenfish," but the Food and Drug Administration granted its approval on Thursday, saying the faster-growing salmon is safe to eat. It could be available in a couple of years. "There are no biologically relevant differences in the nutritional profile of AquAdvantage Salmon compared to that of other farm-raised Atlantic salmon," the agency said. The Obama administration had stalled in approving the salmon for more than five years amid consumer concerns about genetically modified foods. The fish grows twice as fast as normal salmon, so it reaches market size more quickly. AquAdvantage Salmon is engineered by the Massachusetts-based company AquaBounty. Ron Stotish, the company's CEO, said in a statement that the fish is a "game changer that brings healthy and nutritious food to consumers in an environmentally responsible manner without damaging the ocean and other marine habitats." AquaBounty said the fish could be on grocery store shelves in about two years, which is how long it takes the salmon to grow. Once the salmon reach stores, consumers may not know they are eating them. Because there are no material differences between an engineered and a normal salmon, the FDA says the law does not require the fish to be labeled as engineered. AquaBounty says that genetically modified salmon have the same flavor, texture, color and odor as the conventional fish. The FDA released separate wording that would set guidelines for retailers who do want to label the fish, along with additional guidance for voluntary labeling of genetically modified plant foods. Some retailers have said they won't sell the fish at all - retailers Whole Foods, Trader Joe's, Target and Kroger have all said they are not planning to sell AquAdvantage Salmon. Critics have pressured retailers to reject the salmon, which they have labeled "Frankenfish." They worry it could cause human allergies and the eventual decimation of the natural salmon population if it escapes into the wild. "There's no place on our dinner plates for genetically engineered fish," said Lisa Archer of the environmental advocacy group Friends of the Earth. "We will continue to work to ensure the market, from grocery retailers to restaurants, continues to listen to the majority of consumers that don't want to eat this poorly studied, unlabeled genetically engineered fish." Just hours after the announcement, another advocacy group, The Center for Food Safety, said it would sue FDA to block the approval. Alaska Sen. Lisa Murkowski, a Republican, has said the engineered salmon could harm her state's wild salmon industry. She took to the Senate floor to criticize the FDA shortly after the announcement, saying she was "spitting mad." She and other Alaska and Pacific Northwest lawmakers said they will swiftly push legislation to mandate labeling of the modified fish. The FDA said the salmon will be allowed to be raised only in land-based, contained hatchery tanks at two facilities in Canada and Panama, and that other facilities in the U.S. or elsewhere cannot breed or raise the salmon for human consumption. Those restrictions limit the amount of food the company can produce. The agency said that there are "multiple and redundant levels of physical barriers" in the facilities to prevent the escape of fish. The fish would be bred to be female and sterile, so if any did escape, they should not be able to breed. The salmon has an added growth hormone from the Pacific Chinook salmon that allows that fish to produce growth hormone all year long. Engineers have been able to keep the hormone active by using another gene from an eel-like fish called an ocean pout that acts like an "on" switch. Typical Atlantic salmon produce the growth hormone for only part of the year. Bernadette Dunham, director of the FDA's Center for Veterinary Medicine, said the agency "has thoroughly analyzed and evaluated the data and information" submitted by AquaBounty. To approve an engineered animal for human consumption, the agency reviews a company's data and must determine that the food is safe to eat, that the engineering is safe for the fish and that the company's claim - in this case, faster growth - is accurate. AquaBounty's Stotish said he is hopeful the fish will gain consumer acceptance as people learn more about it. "We think time and education and information may allow many of these folks to change their mind," he said of critics.

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