Welcome to DU!
The truly grassroots left-of-center political community where regular people, not algorithms, drive the discussions and set the standards.
Join the community:
Create a free account
Support DU (and get rid of ads!):
Become a Star Member
Latest Breaking News
General Discussion
The DU Lounge
All Forums
Issue Forums
Culture Forums
Alliance Forums
Region Forums
Support Forums
Help & Search
FDA Announces Comment Period for Draft Environmental Assessment for Genetically Engineered Mosquito
http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm490246.htm
FDA Announces Comment Period for Draft Environmental Assessment for Genetically Engineered Mosquito
March 11, 2016
The FDA is releasing for public comment a draft environmental assessment (EA) submitted by Oxitec, Ltd., that assesses the potential environmental impacts of a field trial of the company’s genetically engineered (GE) Aedes aegypti mosquitoes (OX513A) in Key Haven, Florida. Ae. aegypti is known to transmit potentially debilitating human viral diseases, including Zika, dengue, yellow fever and chikungunya.
The National Environmental Policy Act (NEPA) requires federal agencies to assess the environmental impacts of certain actions. Pursuant to FDA regulations, sponsors opening an Investigational New Animal Drug (INAD) file must submit either a draft EA or a claim of categorical exclusion from the EA requirement.
The FDA is also releasing a preliminary finding of no significant impact (FONSI) that agrees with the draft EA’s conclusion that the field trial of such GE mosquitoes will not result in significant impacts on the environment.
Oxitec will not conduct the field trial of its OX513A mosquito until the FDA has had the opportunity to review public comments on the draft EA, and subsequently has issued either a final EA and FONSI or an environmental impact statement.
<>
MORE AT LINK.
FDA Announces Comment Period for Draft Environmental Assessment for Genetically Engineered Mosquito
March 11, 2016
The FDA is releasing for public comment a draft environmental assessment (EA) submitted by Oxitec, Ltd., that assesses the potential environmental impacts of a field trial of the company’s genetically engineered (GE) Aedes aegypti mosquitoes (OX513A) in Key Haven, Florida. Ae. aegypti is known to transmit potentially debilitating human viral diseases, including Zika, dengue, yellow fever and chikungunya.
The National Environmental Policy Act (NEPA) requires federal agencies to assess the environmental impacts of certain actions. Pursuant to FDA regulations, sponsors opening an Investigational New Animal Drug (INAD) file must submit either a draft EA or a claim of categorical exclusion from the EA requirement.
The FDA is also releasing a preliminary finding of no significant impact (FONSI) that agrees with the draft EA’s conclusion that the field trial of such GE mosquitoes will not result in significant impacts on the environment.
Oxitec will not conduct the field trial of its OX513A mosquito until the FDA has had the opportunity to review public comments on the draft EA, and subsequently has issued either a final EA and FONSI or an environmental impact statement.
<>
MORE AT LINK.
http://www.seattletimes.com/nation-world/fda-no-significant-impact-from-field-test-of-gm-mosquitoes/
FDA: No significant impact from test of modified mosquitoes
By JENNIFER KAY
The Associated Press
Originally published Friday, March 11, 2016 at 6:54 am. Updated March 11, 2016 at 10:03 pm
MIAMI (AP) — A field trial releasing genetically modified mosquitoes in the Florida Keys would not harm humans or the environment, according to documents released Friday by the U.S. Food and Drug Administration.
The agency’s Center for Veterinary Medicine released a preliminary finding of no significant impact for the trial of 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 before deciding whether to approve the trial. But the tentative approval could make it easier explore similar trials in the Southeast or Puerto Rico, said Oxitec CEO Haydn Parry.
“Time is not on our side here, if you look at how Zika has been spreading in Brazil and other countries,” Parry said in a conference call with reporters. “The sooner we can start the trial, the sooner we show what we can do.”
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.
<>
FDA: No significant impact from test of modified mosquitoes
By JENNIFER KAY
The Associated Press
Originally published Friday, March 11, 2016 at 6:54 am. Updated March 11, 2016 at 10:03 pm
MIAMI (AP) — A field trial releasing genetically modified mosquitoes in the Florida Keys would not harm humans or the environment, according to documents released Friday by the U.S. Food and Drug Administration.
The agency’s Center for Veterinary Medicine released a preliminary finding of no significant impact for the trial of 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 before deciding whether to approve the trial. But the tentative approval could make it easier explore similar trials in the Southeast or Puerto Rico, said Oxitec CEO Haydn Parry.
“Time is not on our side here, if you look at how Zika has been spreading in Brazil and other countries,” Parry said in a conference call with reporters. “The sooner we can start the trial, the sooner we show what we can do.”
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.
<>
http://thinkprogress.org/health/2016/02/24/3752711/gene-drives-mosquitoes-zika/
The Ethical Risks of Engineering Mosquitoes Into Extinction To Stop Zika
by Alex Zielinski
Feb 24, 2016 12:47 pm
<>
At a Tuesday event in Washington, D.C., a day after President Obama requested $1.9 billion in funds to combat the virus, a panel of epidemiologists, global policy experts, sociologists, and geneticists questioned the ethics of letting scientists take the evolutionary reins.
“It is not something that we should do lightly — to deliberately alter the traits of a wild population,” said Kevin Esvelt, a genetic researcher at MIT’s Media Lab. “Even with something like a mosquito, which most of us are probably not very fond of, there might be unexpected ecological side affects.”
The discussion focused specifically on the newest, most promising solution for eradicating mosquitoes: Gene drives.
Named for their ability to “drive” genes through populations over many generations, this technology throws a wrench into what you learned in high school biology class. Instead of a species’ offspring having a 50 percent chance of inheriting a parent’s gene, gene drives rig the game to ensure that a gene will be inherited by all offspring. New technology has made it possible for scientists to manually trigger gene drives in a species — and, in some cases, choose exactly which trait to modify and how. As in the regular natural selection process, this would have to pass through many generations to see change. But the life expectancy of the mosquito responsible for transferring most diseases is — at most — a month.
A gene drive could erase the trait allowing mosquitoes to reproduce, eventually spreading throughout the population. Or scientists could find a way remove the gene holding Zika bacteria from the mosquito gene pool, an approach recently used to create malaria-resistant mosquitoes.
Though this process may seem like a silver bullet to end the Zika virus, there’s universal agreement that it’s wildly dangerous.
“We now have the power to hijack evolution,” said Eleonore Pauwels, a member of the Science and Technology Innovation Program at the Woodrow Wilson International Center for Scholars in Washington, D.C. “Many people think it’ll be efficient and predictable. But that’s not the case here. We need to know how to talk about to the public, so they understand the risks.”
If the tools fell into the wrong hands, someone could easily drop irreversible damage into the human gene pool — a risk worthy of the technology being deemed a weapon of mass destruction by the U.S. Director of National Intelligence earlier this month.
Pauwels said the lack of knowledge the general population has about the gene drive process — and its risks — is its own “national security problem.” She cited an argument that’s been brought up during past epidemics: Leaving these monumental choices, ones that could alter humanity, up to a small group of elite scientists is unethical on a equity level. Most panelists agreed, but offered little answers to the problem.
“Most people don’t have the bandwidth to think critically about these issues, they’ve got other things to worry about — like getting to work on time, feeding the kids, making enough money to live,” said Andrew Maynard, a professor at Arizona State University’s School for the Future of Innovation in Society. “So then the question is: How do we make decisions in an area like this (as a civilization) where we actually don’t have the mechanisms to engage with large sectors of the population?”
Most of the women affected by Zika live in remote areas of developing countries, and are limited by the amount of information filtered through government channels. Likely, the last thing on their mind is researching a technological solution that could take years of debate before it’s released to the public. Panelists concluded that short-term solutions, like expanding women’s access to reproductive services (like contraceptives and abortions), may have to hold over Zika-affected countries until an ethical process is agreed on.
Not all scientists agree. Brazil has already welcomed British biotech firm Oxitec, the private company leading the development of genetically-edited mosquitoes, into the country. Instead of a gene drive, Oxitec genetically engineers mosquitoes to produce larvae that dies after about four days. Still, many are skeptic of their decision to release these mutant mosquitoes into the wild, and their release has ignited an online conspiracy theory blaming Zika’s existence on the genetically modified mosquito.
These theories are exactly what the panel’s scientists want to avoid. Clarity and understanding should precede fear. In the words of MIT’s Esvelt: “If Zika is what it takes to talk seriously about gene drives in advance of experiments, so that the public conversation can demand that those experiments are transparent, that’s a silver lining to Zika. And we’d be fools not to grasp it.”
The Ethical Risks of Engineering Mosquitoes Into Extinction To Stop Zika
by Alex Zielinski
Feb 24, 2016 12:47 pm
<>
At a Tuesday event in Washington, D.C., a day after President Obama requested $1.9 billion in funds to combat the virus, a panel of epidemiologists, global policy experts, sociologists, and geneticists questioned the ethics of letting scientists take the evolutionary reins.
“It is not something that we should do lightly — to deliberately alter the traits of a wild population,” said Kevin Esvelt, a genetic researcher at MIT’s Media Lab. “Even with something like a mosquito, which most of us are probably not very fond of, there might be unexpected ecological side affects.”
The discussion focused specifically on the newest, most promising solution for eradicating mosquitoes: Gene drives.
Named for their ability to “drive” genes through populations over many generations, this technology throws a wrench into what you learned in high school biology class. Instead of a species’ offspring having a 50 percent chance of inheriting a parent’s gene, gene drives rig the game to ensure that a gene will be inherited by all offspring. New technology has made it possible for scientists to manually trigger gene drives in a species — and, in some cases, choose exactly which trait to modify and how. As in the regular natural selection process, this would have to pass through many generations to see change. But the life expectancy of the mosquito responsible for transferring most diseases is — at most — a month.
A gene drive could erase the trait allowing mosquitoes to reproduce, eventually spreading throughout the population. Or scientists could find a way remove the gene holding Zika bacteria from the mosquito gene pool, an approach recently used to create malaria-resistant mosquitoes.
Though this process may seem like a silver bullet to end the Zika virus, there’s universal agreement that it’s wildly dangerous.
“We now have the power to hijack evolution,” said Eleonore Pauwels, a member of the Science and Technology Innovation Program at the Woodrow Wilson International Center for Scholars in Washington, D.C. “Many people think it’ll be efficient and predictable. But that’s not the case here. We need to know how to talk about to the public, so they understand the risks.”
If the tools fell into the wrong hands, someone could easily drop irreversible damage into the human gene pool — a risk worthy of the technology being deemed a weapon of mass destruction by the U.S. Director of National Intelligence earlier this month.
Pauwels said the lack of knowledge the general population has about the gene drive process — and its risks — is its own “national security problem.” She cited an argument that’s been brought up during past epidemics: Leaving these monumental choices, ones that could alter humanity, up to a small group of elite scientists is unethical on a equity level. Most panelists agreed, but offered little answers to the problem.
“Most people don’t have the bandwidth to think critically about these issues, they’ve got other things to worry about — like getting to work on time, feeding the kids, making enough money to live,” said Andrew Maynard, a professor at Arizona State University’s School for the Future of Innovation in Society. “So then the question is: How do we make decisions in an area like this (as a civilization) where we actually don’t have the mechanisms to engage with large sectors of the population?”
Most of the women affected by Zika live in remote areas of developing countries, and are limited by the amount of information filtered through government channels. Likely, the last thing on their mind is researching a technological solution that could take years of debate before it’s released to the public. Panelists concluded that short-term solutions, like expanding women’s access to reproductive services (like contraceptives and abortions), may have to hold over Zika-affected countries until an ethical process is agreed on.
Not all scientists agree. Brazil has already welcomed British biotech firm Oxitec, the private company leading the development of genetically-edited mosquitoes, into the country. Instead of a gene drive, Oxitec genetically engineers mosquitoes to produce larvae that dies after about four days. Still, many are skeptic of their decision to release these mutant mosquitoes into the wild, and their release has ignited an online conspiracy theory blaming Zika’s existence on the genetically modified mosquito.
These theories are exactly what the panel’s scientists want to avoid. Clarity and understanding should precede fear. In the words of MIT’s Esvelt: “If Zika is what it takes to talk seriously about gene drives in advance of experiments, so that the public conversation can demand that those experiments are transparent, that’s a silver lining to Zika. And we’d be fools not to grasp it.”
Related: http://www.gmwatch.org/news/latest-news/16790-microcephaly-pesticide-spraying-once-again-in-the-crosshairs
5 replies
= new reply since forum marked as read
= new reply since forum marked as read
