FDA Moves on New Food Safety Rules

The FDA proposed new rules today that would require US food distributors to implement additional measures to combat food-borne illness. The guidelines are aimed at improving food handling in both the agriculture and manufacturing sectors after a series of recent disease outbreaks in peanuts, cantaloupe, cheese, and leafy green vegetables that killed scores of Americans.
Food safety organizations welcomed the new rules after a long delay.
“Under the old rules, we’ve been reacting to food contaminations after they happened,” Ami Gadhia of Consumers Union said in a statement. ”The goal here is to prevent deadly outbreaks before people get hurt.  We’re anxious to dive deep into these proposed rules so we can review and comment on the details.”
One rule would require growers, manufacturers and distributors to develop formal plans for preventing contamination, including techniques for cleaning equipment and keeping animals out of crops. Mandatory contingency plans for outbreaks would also be required of businesses, to be approved by the government. The rule would apply to both foreign and domestic suppliers, provided their goods are bound for US consumption.
Another rule proposes enforceable safety standardization in the production and harvesting of produce.
According to the Centers for Disease Control, 3,000 Americans died last year from food-borne illnesses, with an additional 130,000 hospitalized.
In an effort to stave off industry protests Food and Drug Administration officials stressed the rules would be implemented on a risk-based scale, with higher emphasis placed on foods intended to be eaten raw. For example, fresh tomatoes bound for supermarket produce aisles would be held to much stricter standards than beans intended to be cooked and canned.
The FDA estimates it will take roughly a year for the government to move toward implementing the rules, including a 120-day period for public comment. After adoption the largest agriculture businesses will have two years to comply, and small-scale producers will have extensions well beyond that time frame.
Most American food distributors are already in compliance with many of the regulations set out today, but many are voluntary and the government believes stricter enforcement could have prevented deaths from recent highly publicized outbreaks. For example, during the 2011 listeria outbreak in cantaloupes federal investigators found dirty processing equipment and standing pools of old water on the floor of the Colorado farm that produced them. The contaminated produce was linked to 33 deaths.
But these measures are part of the Food Safety Modernization Act, a sweeping series of regulatory changes to the industry that have been tied up in the Obama administration for well over a year. As the first major overhaul of the FDA in decades, President Obama signed the legislation into law with modest Republican support from Congress two years ago to the day, with a one-year deadline to see its first policies put into practice.
Speculation of political motivations at work cropped up during the delays, fueled after the rules were hung-up at the Office of Management and Budget in the review process. Some industry watchers suggest the administration may have sought to deny Republicans an additional talking point during an election year by tabling new proposals.
Pew Research reports there have been 15 major outbreaks regarding FDA-related products since the FSMA was signed into law, resulting in 40 deaths.

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Canada meets key aboriginal demand amid blockades

OTTAWA (Reuters) - Canada's prime minister will meet with native leaders next week to discuss social and economic issues, an olive branch to an angry aboriginal movement that has blockaded rail lines and threatened to close Canada's borders with the United States.
Stephen Harper made no mention of the aboriginal protests in a statement on Friday announcing the January 11 meeting.
But the meeting is a key demand from native Chief Theresa Spence, who has been on a hunger strike for 25 days on an island within sight of the Canadian Parliament in Ottawa.
Spence's spokesman Danny Metatawabin told reporters, on the snowy ground outside her traditional teepee, that she would continue her hunger strike until she was satisfied with the outcome of next week's meeting.
Spence's hunger strike has been one of the most visible signs of a protest movement called Idle No More, which had announced plans for blockades on Saturday all along the U.S.-Canadian border.
It was not clear if these blockades would now be called off, or if there would be any disruptions at the border crossings between the two big trading partners.
The movement is not centrally organized, and Metatawabin said he would not tell others what to do. Several hours after Harper's announcement, the Idle No More website still had a call up for blockades on Saturday.
Demonstrators blocked a Canadian National Railway Co line in Sarnia, Ontario, for about two weeks until Wednesday, and there were shorter blockades elsewhere in the country, including one that delayed passenger trains between Montreal and Toronto for several hours on Sunday.
Harper said next Friday's meeting would address economic development, aboriginal rights and the treaty relationship between the government and native groups. He described it as a follow-up to a meeting with aboriginal leaders last January as well as talks in November with Assembly of First Nations National Chief Shawn Atleo.
"While some progress has been made, there is more that must be done to improve outcomes for First Nations communities across Canada," Harper said in a statement.
DISMAL CONDITIONS
Many of Canada's 1.2 million aboriginals live on reserves where conditions are often dismal, with high rates of poverty, addiction and suicide.
Treaties with Ottawa signed a century ago finance their health and education in a way that many experts say is now dysfunctional.
Speaking to reporters in Oakville, Ontario, Harper sidestepped a question on whether he had agreed to the meeting because of Spence's hunger strike and fear the protests could snowball like last year's Occupy Movement.
Asked about the demonstrations, he said: "People have the right in our country to demonstrate and express their points of view peacefully as long as they obey the law, but I think the Canadian population expects everyone will obey the law in holding such protests."
Idle No More was sparked by legislation that activists say Harper rushed through Parliament without proper consultation with native groups and which affects their land and treaty rights. But it has broadened into a complaint about conditions in general for native Canadians.
In her meeting with reporters after Harper's announcement, Spence said she planned to attend the meeting in person along with three of her supporters and she wanted the governor general - Queen Elizabeth's representative - and the Ontario premier to attend as well.
She stood flanked by her daughter and several supporters, some of them holding up feathers. There were several minutes of drumming and singing before she and her spokesman began talking.
When asked what she needed to hear from the prime minister in order to start eating again, she said, "a positive result because there's a lot of issues we need to discuss" and that they should discuss the issues as equal partners.

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Competition affects who gets a liver transplant

NEW YORK (Reuters Health) - More competition between medical centers that perform liver transplants may mean sicker patients get lower-quality donor organs, a new analysis suggests.
When more than one center has patients on the same donor list, the centers have an incentive to get organs for as many of their own patients as possible, researchers explained.
So doctors are more likely to take the first available organ when their patient is at the top of the transplant list - whether or not that pairing has the best chance to succeed - rather than risk the organ will go to another center.
"There is the question whether competition decreases the ability of a center to better match donor and recipient characteristics," Dr. John Paul Roberts from the University of California, San Francisco and his colleagues wrote.
They analyzed data on more than 38,000 liver recipients who had transplants from non-living donors between 2003 and 2009.
The transplants were done at 112 medical centers in 47 so-called distribution areas - some that were covered by only one center and some that fed organs to multiple transplant centers.
Roberts and his colleagues found "clinically important differences" showing patients who received organs were initially worse off, with a higher risk of dying or having their transplant fail, in areas that had more medical centers in competition for the same organs.
For example, 10 percent of patients who received organs at centers with no competition had the worst scores for liver disease severity pre-transplant, compared to more than 28 percent of those in the high-competition distribution areas.
Areas with high competition also transplanted more organs that were considered at higher risk of failing, according to the new findings published in the journal Liver Transplantation.
Although that might not be the best way of distributing organs on a society-wide scale, it could be considered a plus for the people who otherwise wouldn't get an organ or for livers that would otherwise be considered too low quality and be discarded.
"If you're a sick, high-risk patient… then it's in your interest that somebody will take more of a risk on you. The alternative is not surviving," said Dr. Michael Charlton, a liver disease researcher from the Mayo Clinic Transplant Center in Rochester, Minnesota.
Competition, he said, does increase access for patients. So people who are very sick and are turned away by a center that's the only place for transplants in its distribution area might have better luck elsewhere - if they can afford to travel, that is.
"The practice, in terms of choosing patients who can undergo liver transplantation and accepting organs that are already listed for transplantations, varies significantly between centers," Charlton, who wasn't involved in the new study, told Reuters Health.
Still, he cautioned that the way the researchers measured competition - comparing the market shares for each transplant center in a given area - doesn't account for the effect of a center's reputation for good outcomes, for example.
In that situation, a popular, higher-volume center would experience less competition from other centers and might also have better transplant records - so pure competition might not be the only explanation for outcomes.
Charlton pointed to the Scientific Registry of Transplant Recipients as a place where patients can go to see how many people various centers have on their organ waitlist in addition to how well their patients do after getting a transplant. (For liver transplants, that information can be found here:).

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HBO to make adaption of AIDS play

Julia Roberts and Mark Ruffalo will star in an HBO movie adaptation of "The Normal Heart," the play about the onset of the AIDS crisis in New York City in the early 1980s.
HBO said Friday that Ryan Murphy, maker of "Eat Pray Love" and the TV show "Glee," will direct the film.
Larry Kramer's play about the men who joined him to help form the Gay Men's Health Crisis debuted in 1985 and was brought to Broadway again in 2011, winning a Tony Award for best revival.
Roberts will portray Dr. Emma Brookner, a paraplegic doctor who treated several of the earliest AIDS victims. Ruffalo plays Ned Weeks, who sought answers when he saw the disease begin to kill many gay people he knew.

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FDA Aims to Reduce Contaminated Food Via New Rules

With one in six people in America developing a foodborne illness each year , the U.S. Food and Drug Administration is moving forward with the proposal of two new rules as required by the Food Safety Modernization Act , FSMA, signed into law Jan. 4, 2011. Some might say, "At long last," since this is the first major action by the federal agency since the legislation was signed into law by President Barack Obama.
New FDA-Proposed Rules Address Manufacture, Handling and Processing of Food
The first rule deals with foreign and domestic manufacturers of food for human consumption would require these manufacturers to develop a plan to prevent their products from causing foodborne illnesses, and should a problem develop, the manufacturers would be required then to develop a plan to address the issue.
The second rule addresses farms that grow fruits and vegetables by setting national standards for water quality used in the production and handling of such crops.
Implementation of New Food Safety Rules
The FDA's proposed new rules will be published in the Federal Register as required with a 120-day open period for comments and concerns by citizens before the new rules will become final.
Don't look for immediate enactment of the rules, even when the public comment period comes to and end. The federal agency will review the comments and make any necessary adjustments to the rules, with the beginning of implementation expected to be about a year, Taylor explained to USAToday.com .
The deputy commissioner also revealed that implementation of these rules will require re-training of government inspectors, but as of yet no one knows where funding will come from for the changes.
New Food Safety Regulations Shift Focus from Reaction to Prevention
Michael R. Taylor, deputy commissioner for foods and veterinary medicine at the FDA, said in an interview that the new rules "set the basic framework for a modern, science-based approach to food safety" and shift the focus of food safety to one of prevention rather than reaction.
Taylor addressed the rationale that required two years for the federal agency to go from Jan. 1, 2011 to enactment on the law: The FDA has come to the realization that one-size-fits-all rules and regulations don't address the complexity of the issues, or the practicality of genuine solutions.
TheHill.com reported that some food safety advocates were angered by the long delay, and the Center for Food Safety filed a lawsuit in August against the FDA and the Obama administration for bypassing interval deadlines in the law without taking action.
Bottom Line
The U.S. Centers for Disease Control and Prevention estimated that nearly 130,000 Americans are hospitalized each year from foodborne illnesses and approximately 3,000 deaths annually result from these preventable infections. The safety of food in the United States is either important or it isn't; the federal government dragging its feet in the implementation of, and funding for, the Food Safety Modernization Act belies the very law it established.

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