Showing posts with label enters. Show all posts
Showing posts with label enters. Show all posts

Saturday, June 15, 2013

If Genetically Engineered Seafood Enters U.S. Market, Major Grocery Stores Say They Won’t Sell It


A group of major grocery retailers — including Whole Foods, Trader Joe’s, and Aldi — have pledged not to sell genetically engineered (GE) seafood if it’s approved in the U.S., Friends of the Earth announced Wednesday. The retailers are among more than 2,000 national and local grocery stores that have signed a pledge as part of the environmental group’s new campaign to push grocery stores to refuse to sell GE seafood.

The announcement comes as the Food and Drug Administration appears poised to approve what would be the first non-plant GE food to enter the U.S. market. AquAdvantage Salmon — which contain a Chinook salmon gene allowing the fish to grow about twice as fast as a wild Atlantic salmon — passed the FDA’s environmental assessment, which was released last year. Along with salmon, the Center for Food Safety reports that there are at least 34 other species of fish undergoing GE development around the world, including tilapia, trout and flounder.

The debate surrounding genetically modified foods, or GMOs, has intensified in recent months. Whole Foods announced earlier this month that it would label all GMO foods sold in Whole Foods stores by 2018, becoming the first national grocery store to set a timeline on GMO labeling. California’s Proposition 37, which would have mandated GMO labeling in the state, was narrowly defeated in November, after food industry giants like Monsanto and Hershey poured $44 million dollars into an anti-Prop 37 campaign. Polling shows that more than 90 percent of consumers support GMO labeling, and a 91 percent of Americans don’t want GE meat and fish in the U.S. marketplace.

The grocery retailers’ pledges are encouraging, but they don’t make up for the FDA’s oversight in labeling GE salmon as environmentally sound. Opponents of GE seafood stress that not enough research has been done on its health effects, and that GE fish could pose an environmental threat if they escape into open waters. With their ability to grow more quickly than other salmon, GE salmon could out-compete wild salmon for food and space, and could potentially mate with wild seafood, weakening the wild species’ gene pool. AquAdvantage’s developer AquaBounty maintains that all of its salmon are grown as sterile females, but during a 2010 FDA hearing, AquaBounty clarified that 95 to 99 percent of its salmon were sterile — which means up to 750,000 of the eggs AquaBounty plans to grow could be fertile. On top of that, even farmed salmon that aren’t genetically modified pose potential health and environmental risks — they typically contain higher concentrations of PCBs, pesticides and other toxins; generate vast amounts of waste, which pollutes the water surrounding their pens and can harbor disease; and emit nearly as much greenhouse gasses as pork. GE farmed salmon will also carry all those risks.

There are still many other grocery retailers in the U.S. that haven’t signed the pledge, which means that if AquAdvantage salmon are approved, they will still find their way into the American market. The FDA hasn’t had much success with encouraging the food industry to self-regulate on its own, so the federal government will need a broader policy to limit Americans’ exposure to GMO foods — by labeling them or, in the case of GE salmon, by keeping them off shelves altogether.


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Tuesday, March 5, 2013

Boehringer Ingelheim Ohio subsidiary enters consent decree

Jan 31 (Reuters) - Ben Venue Laboratories Inc., a unit of German drug company Boehringer Ingelheim, may not freely make or distribute drugs from its facility in Bedford, Ohio, until U.S. regulators have determined it is in compliance with good manufacturing standards.

The U.S. Food and Drug Administration said a federal judge approved a consent decree on Thursday under which the company must bring its facility into compliance with regulatory requirements or face fines and other penalties.

Ben Venue has repeatedly violated good manufacturing practices, the FDA said in a statement. Recent FDA inspections found that poorly maintained equipment deteriorated to the point that it shed particles into injectable drugs.

"The company's failure to promptly address these problems put patients at risk of receiving poor quality drugs and compromises the availability of medically necessary products," said Melinda Plaisier, acting associate commissioner for regulatory affairs.

Ben Venue's chief executive officer, its vice president of operations and its vice president of quality operations were named defendants in the consent decree which was signed by Judge Lesley Wells of the U.S. District Court for the Northern District of Ohio.

A spokesperson for Boehringer Ingelheim was not immediately available for comment. The company this month said in a statement it had voluntarily entered a consent decree and would be permitted to continue manufacturing more than 100 drugs. The agreement was subject to approval by the judge.

Ben Venue manufactures products including sterile injectable drugs. It also makes drugs for other companies. FDA said it is working with Ben Venue to prioritize and ensure the availability of the company's medically necessary drugs to respond to and prevent potential drug shortages.

(Reporting by Toni Clarke; Editing by James Dalgleish)


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