The U.S. Food and Drug Administration, part of the Department of Health and Human Services, today released for public comment draft guidance on the regulation of genetically engineered (GE) animals. The guidance document is intended to clarify the FDA's regulatory authority in this field, as well as the requirements and recommendations for producers of GE animals and products derived from GE animals.
"This is a cutting-edge technology that has significant implications, including real benefits, not just for human health, but also for animal health, such as developing disease-resistant animals," said CVM Director Bernadette Dunham, D.V.M., Ph.D. "We look forward to the public comments to help refine our thinking and approach."
The draft guidance describes how the FDA may exercise enforcement discretion, that is, not require premarket approval, for some GE animals depending on potential risk, as we did after reviewing information about Zebra danio, aquarium fish genetically engineered to glow in the dark. For example, the draft guidance states the FDA's intent to exercise enforcement discretion for laboratory animals used for research and kept in confined conditions. The agency does not expect to exercise enforcement discretion for animal species traditionally consumed as food and expects to require approval of all GE animals intended to go into the human food supply.
The draft guidance describes how the FDA regulates heritable rDNA constructs, that is, constructs inherited from one generation to the next. Non-heritable constructs, such as those used for gene therapy to treat individual animals, may be the subject of a subsequent guidance.
FDA issues rules for genetically modified animals Thu Sep 18, 2008 3:42pm EDT Email | Print | Text [+] 1 of 2Full SizeBy Christopher Doering
WASHINGTON (Reuters) - Animals genetically engineered to produce drugs and healthier foods will be subjected to review to help protect consumers from any unknown risks, the U.S. Food and Drug Administration said on Thursday.
The FDA published detailed proposed guidelines that producers of genetically engineered animals would have to follow to determine if there are any risks to humans, the environment and the animals themselves.
The proposed guidelines bring the decades-old technology of genetic engineering one step closer to the consumer's dinner table. Genetically modified cattle, pigs, fish and goats are being made for a variety of uses.
Some produce pharmaceuticals in milk or blood. Others have traits to make them resistant to diseases such as mad cow disease or to produce more healthful meat or milk.
"Many kinds of genetically engineered animals are in development, although none has yet been approved by the agency for marketing," said FDA Deputy Commissioner Randall Lutter.
Foods produced from some bioengineered animals will not have to be labeled, FDA said. The agency is inviting public comment on its proposals and could modify them before they become final.
Consumer groups said the move was a good first step but they were disappointed that the FDA would not require all genetically modified animal food products to be labeled.
"It is incomprehensible to us that FDA does not view these animals as different from their conventional counterparts," said Jean Halloran, director of food policy initiatives at Consumers Union. Continued...
Consumers have a right to know if the ham, bacon or pork chops they are buying come from pigs that have been engineered with mouse genes."
But the FDA said labeling will be required if there is a significant change in the food that makes it different from ordinary products.
Some animals have been made to produce healthier foods, such as pork with higher levels of omega-3 fatty acids. Those would need a label.
Producers will be required to describe the DNA and how it behaves in the animal, the impact of the change on the animal's health and show the product is not different from traditional food.
The companies also will have to inform the FDA how they will keep track of the animals and dispose of them when they die. If there is a high risk, the FDA might require the animals to be sterilized to prevent them from breeding with other animals.
The FDA said it has the authority to regulate genetically engineered animals through the Federal Food, Drug and Cosmetic Act.
The measure identifies a drug as anything that changes the "structure or function" of the person or animal. In this case, an animal is genetically modified by adding a piece of DNA to introduce a desired trait.
(Reporting by Christopher Doering; Editing by Maggie Fox and Cynthia Osterman)
Ook de FDA heeft soms dezelfde instelling als de Gemiddelde jan kees.
Zo hiermee eindig ik die discussie. Helaas NBeets gaat het er vaak om wie zitten er in en welke belangen dient het,hoeveel presidents vriendjes hebben er belang en genoeg power. ;-)
Mooo-ve over, FDA POSTED: Friday, September 05, 2008 FROM BLOG: Gristmill - Environmental news and commentary
The following blog post is from an independent writer and is not connected with Reuters News. The opinions and views expressed herein are those of the author and are not endorsed by Reuters.com.
Consumer market rejection seems to be the ongoing theme of U.S. food politics in the waning days of Bush's inept Food and Drug Administration. Given FDA's repeated failure to protect our nation's food supply or to respond quickly and appropriately to outbreaks of food-borne illnesses, consumers have turned to food companies and demanded that they now take the lead in safeguarding our nation's food.
Public opposition to milk and meat from clones has caused 20 major food companies, restaurants, dairies, and supermarket chains to refuse to produce, use or sell food from clones. These companies have taken action despite FDA's claims that food from clones and their offspring is safe.
Last January, FDA announced that it would allow clones and their offspring to enter the food supply despite the lack of scientific studies available to prove that clones are safe for human consumption. The FDA won't require any special procedures for tracking and handling food products from clones and their offspring or require product labeling. This unfortunate situation not only deprives people of their right to know the processes used to produce the milk and meat they consume, but it also deprives them of their right to choose or refuse such foods.
U.S. consumers are not alone in their opposition to food from clones. Yesterday, the European Parliament overwhelmingly passed a resolution calling for an E.U.-wide ban on the use of animal clones and their offspring in food. They also voted to prohibit the import of clones, their offspring, semen, embryos, and milk and meat derived from cloned animals or their offspring. In January, the European Group on Ethics released a report which stated that it didn't see any convincing arguments to justify the use of cloning for food production, particularly given the suffering and health problems surrogates and clones experience.
Imagine a U.S. government agency calling for the prohibition of a food technology, staunchly supported by agribusiness, because it deems the technology "ethically questionable"! That resolution simply would never happen here, but that's exactly what happened in Europe.
In this country, we have neither a standard nor a process for assessing the ethics or cruelty of a given food production technology. That's not surprising given the fact that the U.S. leads the world in unencumbered and unregulated corporate behavior. For the most part, ethical considerations in food production are only taken into account if citizens manage to put them to a vote on a ballot initiative, like Californians did for this November's election. If passed, Proposition 2, the Prevention of Farm Animal Cruelty Act, would halt the use of battery cages for laying hens, and crates for veal and pregnant and nursing pigs. Clearly, the FDA and USDA are not prepared to take this type of ethical action, so concerned citizens have no other choice but to put the issue to a vote and force companies to change their production practices through public mandate.
FDA's failure to pursue its primary mission as protector of our nation's food supply is also the reason why food safety, animal welfare, environmental, and consumer groups have decided to take matters into their own hands with respect to clones. This past May, the Center for Food Safety and Friends of the Earth began surveying companies about their position on clones. So far, 20 leading food processors, restaurants, retailers, and dairies have said that they won't produce, use or sell milk or meat products from cloned animals. Action taken by these companies represents a growing industry trend of responding to consumer demands for better food safety, environmental protection, and animal welfare practices in the absence of FDA protections.
The list of companies rejecting clones reads like a page out of "Who's Who" in the food industry: Kraft Foods, General Mills, Gerber/Nestle, Campbell Soup Company, Gossner Foods, Smithfield Foods, Ben & Jerry's, Amy's Kitchen, California Pizza Kitchen, Hain Celestial, PCC Natural Markets, Albertsons, SUPERVALU, Harris Teeter, and Clover-Stornetta, Oberweis, Prairie, Byrne, Plainview, and Cloverland dairies. Nine of these companies also refuse to use ingredients from the offspring of clones, while the other 11 remain silent on the issue. Those industry leaders include: Ben & Jerry's, Amy's Kitchen, Clover-Stornetta, Oberweis Dairy, Prairie Farms Dairy, Plainview Dairy, Gossner Foods, PCC Natural Markets, and Hain Celestial.
Obviously, the struggle to keep food from clones and their offspring out of America's food supply is far from over. Since we can't rely upon FDA to ensure safe food, it's up to all of us to use our consumer power to keep our food and farm animals protected from the use of cloning technology.
hebbie de koers al gezien tenopzichte van de beurs ???
ja meer dan 2 keer zo goed dan de AMX index! verder maakt het allemaal geen fluit uit wat de koers doet op dit niveau. het gaat zometeen om de euro's, niet om de centjes van nu.
hebbie de koers al gezien tenopzichte van de beurs ???
ja meer dan 2 keer zo goed dan de AMX index! verder maakt het allemaal geen fluit uit wat de koers doet op dit niveau. het gaat zometeen om de euro's, niet om de centjes van nu.
In potentie is Pharming een heel grote inwording. Laten we Maandag maar eens een leuke stap maken.
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