Sunday, June 26, 2011

Taylor Talks FSMA Implementation, Funding

Taylor Optimistic on FSMA Implementation, Funding

Food and Drug Administration "food safety czar" Michael Taylor expressed cautious optimism Monday that FDA can resolve what has become a primary concern: a huge new regulatory mandate coupled with the threat of no resources for implementation.

Taylor told an audience of state and local food and drug officials that while the funding to implement the newly enacted FDA Food Safety Modernization Act -- a sweeping new responsibility for FDA -- remains uncertain, the agency remains optimistic that "at the end of the day, it won't be so dire."

As he has several times in outreach speeches to the food policy community, Taylor pointed out that FDA has a "a huge workload." And even though public health officials are working hard, the agency will likely not meet all of its deadlines. On top of the back log, FDA has no idea what its budget will be for fiscal year 2012. An agriculture appropriations bill that cleared the House last week would cut food safety programs $87 million below fiscal year 2011.

Under FSMA, the agency has to craft standards for produce safety and preventive controls, establish a risk-based inspection program, conduct a traceability pilot, and the list goes on.

"This is part of the empathy-inducing aspect of the law, because it is, in fact, a huge work load. But one that we readily embrace," said Taylor in his remarks at the opening session of Association of Food and Drug Officials conference in Plano, Texas.

"There's a lot of work going on. People are energized," added Taylor, emphasizing, again, that it is "impossible to meet all the deadlines."

"The reality of our resources and the processes of getting rules's physically impossible to do all of them," he said. The FDA is working to prioritize these issues and push through "the most essential building blocks" first.

All of these initiatives, of course, depend on resources.

"[The resource challenge] is a serious one," said Taylor. "We have been given really a whole new job...been given a mandate to build a whole new system of food safety oversight."

"While we build on a strong foundation and we have a base of resources that we can do a lot with, you can't build a new house without new financing," he said. "You can't pretend that all the new programs and systems that this law calls for can be achieved without new resources."

Without more funding, FDA can still create regulations, though rulemaking could be delayed, according to Taylor, but it remains to be seen whether the agency will be able to build the capacity to enforce them.

"I think we all know that words on the page don't make food safer," said Taylor. "What do you do to make those come to life? What investments do we have to make to make those regulations come to life so they can have the effect we want them to have on strengthening food safety?"

Taylor pointed to the need for real investments in science and research as well as state and local capacity as critical elements of the new system.

"Again, you can't do this without the resources. The current budget situation does paint a challenging picture," said Taylor, noting that a patchwork of continuing resolutions to keep the government funded -- as we saw in 2011 -- makes it nearly impossible to plan ahead.

"When Congress gives us our budget over half way through the fiscal year it's very difficult to use that money in as orderly a way as possible. You cant use that money to hire the experts you need because the hiring process is such that you wont get them hired until the end of the fiscal year." All of this compounds the resource issue.

"We just have to work together to figure this out," said Taylor. "We can make good, efficient use of whatever we've got, but figuring out a way to get a more predictable flow of resources is crucial for all of us."

Thursday, June 16, 2011

House Moves to Ban GE Salmon, Ag Debates Continue

The House of Representatives continued debate yesterday on an agriculture appropriations bill that affects key food safety programs. The bill still contains significant cuts to the U.S. Food and Drug Administration and the U.S. Department of Agriculture's Food Safety and Inspection Service, but has yet to be adopted by the lower chamber.

Lawmakers spent the better part of Tuesday and Wednesday debating a series of amendments affecting a wide variety of programs--from federal nutrition to conservation to food safety.

Late Wednesday, the House approved an amendment by Congressman Don Young (R-AK) that would bar the FDA from spending money to approve an application for controversial genetically-engineered (GE) salmon. If the agency were to approve the GE fish--which grow rapidly, reducing cost of production--it would be the first GE animal approved for human consumption.

The measure passed the Republican-controlled House by voice vote.

AquaBounty, the company that developed the salmon technology, insists the salmon pose no threat to human health and will be kept out of wild salmon populations; but consumer groups and much of the seafood industry remain staunchly opposed to the idea.

The modified fish, formally known as AquaAdvantage salmon, are essentially Atlantic salmon with an inserted growth gene from a Chinook salmon and an antifreeze gene from an ocean pout. They grow twice as fast as typical Atlantic salmon and require approximately 10 percent less feed to achieve the same weight.

Lawmakers from salmon states--who often call GE salmon "alien fish," "frankenfish" or "monsters"-- have been fighting for months to pass legislation to block FDA's expected approval of the fish.

"Frankenfish threatens our wild stocks, their habitat, our food safety, and would bring economic harm to Alaska's wild salmon fishermen," said Senator Begich (D-AK) in February, when a similar measure was introduced in the upper chamber, adding that he believes the modified fish are "risky, unprecedented and unnecessary."

AquaBounty argues that its Salmon would complement, not harm, existing wild fisheries.

"The availability of AquAdvantage Salmon can help meet demand for a safe and sustainable food by providing a US-grown farmed Atlantic salmon, without stressing the valuable and finite Alaskan fisheries, preserving their markets," the company has stated.

However, members of Congress from several key salmon states, on both sides of the aisle, have now signed onto bills to block the salmon. The Senate has not yet voted on the matter.

The House is expected to continue debate on the agriculture appropriations and to vote on the spending bill this week.  

Thursday, June 9, 2011

China Genetically Modifying Cows To Produce Human Breast Milk

Updated: Wednesday, 08 Jun 2011, 7:54 AM EDT
Published : Wednesday, 08 Jun 2011, 7:54 AM EDT

BEIJING - Chinese scientists have genetically modified dairy cows to produce human breast milk, and hope to be selling it in supermarkets within three years.

The milk produced by the transgenic cows is identical to the human variety, with the same immune-boosting and antibacterial qualities as breast milk, scientists at China's Agricultural University in Beijing said.

The transgenic herd of 300 was bred by inserting human genes into cloned cow embryos which were then implanted into surrogate cows. The technology used was similar to that used to produce Dolly the sheep, the first mammal to be cloned by scientists, in Scotland.

The milk is still undergoing safety tests, but with government permission it will be sold to consumers as a more nutritious dairy drink than cow's milk.

Workers at the university's dairy farm have already tasted the milk -- and said it is sweeter and stronger than the bovine variety, according to Sky News .

"It's good," said worker Jiang Yao. "It's better for you because it's genetically modified."
The scientists have also produced animals that are resistant to mad cow disease, as well as beef cattle that are genetically modified to produce more nutritious meat.

The director of the research project, Professor Li Ning, said Western concerns about the ethics of genetic modification are misplaced.

"There are 1.5 billion people in the world who don't get enough to eat," he said. "It's our duty to develop science and technology, not to hold it back. We need to feed people first, before we consider ideals and convictions."

Tuesday, June 7, 2011

Bill to Accelerate Biotech Approvals in U.S.

Representative Stephen Fincher, a congressman from Tennessee, USA, introduced a legislation to speed up the process of approval for biotech crops. Fincher, who is also a farmer, called the bill as 'Expediting Agriculture Through Science (EATS) Act'. The legislation would allow Animal Plant and Health Inspection Service (APHIS) to have 180 days "to approve or deny a petition for non-regulated status, with an additional 60 days if needed to ensure the safety of the environment and compliance is met before deeming the petition approved."

Fincher emphasized the need for a more efficient approval process to keep the U.S. farmers leaders in biotech crop production.

The original news is available at