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.
Read More..

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.
Read More..

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:).
Read More..

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.
Read More..

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.
Read More..

Tubular raises $2.5 million to serve burgeoning YouTube industry

SAN FRANCISCO (Reuters) - Tubular, a small San Francisco start-up that provides analytics for YouTube content creators, has raised $2.5 million in venture capital in the latest sign of how far the business ecosystem has evolved around the Google-owned video repository.
YouTube was once known as Wild West of online video, but over the past two years Google has focused on raising the quality of YouTube content through a series of direct investments and the cultivation of third-party "networks".
The result is a cluster of small studios, mostly based in Los Angeles, that acts like a digital Hollywood, pumping out slick YouTube hits.
With the ultimate goal of hosting enough high-quality content to lure big-spending advertisers to YouTube, Google doled out more than $100 million last year in grants to its networks and bedroom stars.
In May Google led a group of investors who poured $35 million into Machinima, a leading network, to stoke growth in the YouTube industry.
That market has now grown to the point that it can support its own start-ups, says Tubular's founder Rob Gabel.
COMPETITION
As more semi-professional and professional YouTube creators enter the sector, with increasing competition among them, there is a growing need for analytical services.
Tubular is one such service, allowing customers to monitor and measure when videos get the most views and comments, or the sources of referred traffic.
The software includes a dashboard that displays the real-time analytics, which are generated by tapping into a stream of data provided by YouTube.
"If YouTube is a multibillion-dollar market, then that's billions of dollars going out to content creators who can then invest that again," said Gabel, a former Machinima employee.
"On every platform, from Google to Facebook to Twitter, people have turned to third parties' helpful tools."
At a high level, the pie is large and continuing to grow rapidly. Former Citi analyst Mark Mahaney estimates that YouTube will bring Google a total of $3.6 billion in 2012.
Rich Heitzmann, a co-founder of FirstMark Capital, which led Tubular's latest funding round, said that Google is far from wringing out all of the potential revenue from YouTube.
"We think the ecosystem is at least the size of Facebook's, considering it has a billion users and if you consider the time spent on YouTube," Heitzmann said.
"The advertising opportunities are there, and yet the ecosystem hasn't evolved technologically."
SUSTAINABLE BUSINESS
Other investors in Tubular's first tranche of equity financing included High Line Venture Partners, SV Angel, Lerer Ventures and Bedrocket Media Ventures.
Still, Gabel is betting that he can create a long-term, sustainable business on YouTube's platform at a time when some Silicon Valley companies are wary of building on the backs of larger companies.
Twitter, for instance, courted controversy this year when it made a business decision to shut off its firehose of data for a number of popular third-party developers to drive more visitors to its own site.
Allen DeBevoise, the CEO of Machinima who is also a Tubular investor, said that YouTube has reason to foster its independent developers rather than squash them.
"It's a thriving and fast-moving ecosystem now," he said. "But a lot of players are needed to make it all work."
Though Gabel acknowledges that the YouTube industry's rapid expansion is no guarantee of success, he has high hopes.
Read More..

Instagram tests new limits in user privacy

SAN FRANCISCO (Reuters) - Instagram, which spurred suspicions this week that it would sell user photos after revising its terms of service, has sparked renewed debate about how much control over personal data users must give up to live and participate in a world steeped in social media.
In forcefully establishing a new set of usage terms, Instagram, the massively popular photo-sharing service owned by Facebook Inc, has claimed some rights that have been practically unheard of among its prominent social media peers, legal experts and consumer advocates say.
Users who decline to accept Instagram's new privacy policy have one month to delete their accounts, or they will be bound by the new terms. Another clause appears to waive the rights of minors on the service. And in the wake of a class-action settlement involving Facebook and privacy issues, Instagram has added terms to shield itself from similar litigation.
All told, the revised terms reflect a new, draconian grip over user rights, experts say.
"This is all uncharted territory," said Jay Edelson, a partner at the Chicago law firm Edelson McGuire. "If Instagram is to encourage as many lawsuits as possible and as much backlash as possible then they succeeded."
Instagram's new policies, which go into effect January 16, lay the groundwork for the company to begin generating advertising revenue by giving marketers the right to display profile pictures and other personal information such as who users follow in advertisements.
The new terms, which allow an advertiser to pay Instagram "to display your username, likeness, photos (along with any associated metadata)" without compensation, triggered an outburst of complaints on the Web on Tuesday from users upset that Instagram would make money from their uploaded content.
The uproar prompted a lengthy blog post from the company to "clarify" the changes, with CEO Kevin Systrom saying the company had no current plans to incorporate photos taken by users into ads.
Instagram declined comment beyond its blog post, which failed to appease critics including National Geographic, which suspended new posts to Instagram. "We are very concerned with the direction of the proposed new terms of service and if they remain as presented we may close our account," said National Geographic, an early Instagram adopter.
PUSHING BOUNDARIES
Consumer advocates said Facebook was using Instagram's aggressive new terms to push the boundaries of how social media sites can make money while its own hands were tied by recent agreements with regulators and class action plaintiffs.
Under the terms of a 2011 settlement with the Federal Trade Commission, Facebook is required to get user consent before personal information is shared beyond their privacy settings. A preliminary class action lawsuit settlement with Facebook allows users to opt-out of being included in the "sponsored stories" ads that use their personal information.
Under Instagram's new terms, users who want to opt-out must simply quit using the service.
"Instagram has given people a pretty stark choice: Take it or leave, and if you leave it you've got to leave the service," said Kurt Opsahl, a senior staff attorney with the Electronic Frontier Foundation, a Internet user right's group.
What's more, he said, if a user initially agrees to the new terms but then has a change of mind, their information could still be used for commercial purposes.
In a post on its official blog on Tuesday, Instagram did not address another controversial provision that states that if a child under the age of 18 uses the service, then it is implied that his or her parent has tacitly agreed to Instagram's terms.
"The notion is that minors can't be bound to a contract. And that also means they can't be bound to a provision that says they agree to waive the rights," said the EFF's Opsahl.
BLOCKING CLASS ACTION SUITS
While Facebook continues to be bogged in its own class action suit, Instagram took preventive steps to avoid a similar legal morass.
Its new terms of service require users with a legal complaint to enter arbitration, rather than take the company to court. It prohibits users from joining a class action lawsuit unless they mail a written "opt-out" statement to Facebook's headquarters in Menlo Park within 30 days of joining Instagram.
That provision is not included in terms of service for other leading social media companies like Twitter, Google, YouTube or even Facebook itself, and it immunizes Instagram from many forms of legal liability, said Michael Rustad, a professor at Suffolk University Law School.
Rustad, who has studied the terms of services for 157 social media services, said just 10 contained provisions prohibiting class action lawsuits.
The clause effectively cripples users who want to legally challenge the company because lawyers will not likely represent an individual plaintiff, Rustad argued.
"No lawyers will take these cases," Rustad said. "In consumer arbitration cases, everything is stacked against the consumer. It's a pretense, it's a legal fiction, that there are remedies."
Instagram, which has 100 million users, allows consumers to tweak the photos they take on their smartphones and share the images with friends. Facebook acquired Instagram in September for $715 million.
Instagram's take-it-or-leave-it policy pushes the envelope for how social networking companies treat user privacy issues, said Marc Rotenberg, the executive director of the Electronic Privacy Information Center.
"I think Facebook is probably using Instagram to see how far it can press this advertising model," said Rotenberg. "If they can keep a lot of users, then all those users have agreed to have their images as part of advertising.
Read More..

FTC tightens rules protecting children's online privacy

WASHINGTON (Reuters) - The government announced tighter rules on Wednesday to protect children's online privacy by restricting the collection of data, like the child's location, unless parents consent.
The actions by the Federal Trade Commission mark an update to rules that were based on the 1998 Children's Online Privacy Protection Act, developed when most computers were big beige boxes sitting under office desks instead of smartphones in backpacks, and online social media was unheard of.
"The Commission takes seriously its mandate to protect children's online privacy in this ever-changing technological landscape," FTC Chairman Jon Leibowitz said in a statement.
Under the updated rule, IP addresses, which are unique to each computer, will be added to the list of personal information that cannot be collected from children without parental consent if the data will be used for behavioral advertising or tracking.
Location, photos, videos and audio files were also added to the definition.
Leibowitz said the commission struck "the right balance between protecting innovation that will provide rich and engaging content for children, and ensuring that parents are informed and involved in their children's online activities."
But Senator John Rockefeller, a West Virginia Democrat and chair of the Senate Commerce, Science and Technology Committee, which oversees the FTC, said he had wanted legislation that went further.
"There are groups that will complain about it (COPPA being too weak), and so will I, but we can't do anything more about it right now," he said. "Children's privacy as far as I am concerned is an absolutely top line issue."
Privacy advocates and advertising companies had been watching closely to see if the agency would go through with a pledge made in August to add IP addresses to the restrictions.
Advertisers had argued against the move since several people in a family - adults and children - could use the same computer. Privacy advocates said it was needed to protect children.
Also under the updated rule, plug-ins and other third parties connected to children's websites and apps cannot allow third parties to collect information on children without parental consent.
Big companies would be able to deal with the changes but the tighter regulators could be onerous for smaller firms, said John Feldman of the law firm Reed Smith LLP.
"I represent companies who are trying to sell products and services," he said. "The bigger companies feel like they can deal with it. There are significant costs that will be associated with this."
Privacy advocate Kathryn Montgomery, who teaches at American University, said the update was needed, given the growth of social networks and mobile computing. She urged the FTC to be tough about enforcing the rules.
"The new rules should help ensure that companies targeting children throughout the rapidly expanding digital media landscape will be required to engage in fair marketing and data collection practices," she said.
The proposal also specifies that family websites, which are websites aimed at children and adults, would be allowed to screen users to determine their ages and only provide protection to children under age 13.
Currently, all visitors to the websites must be treated as if they are under age 13.
The FTC's rule implementing COPPA became effective in 2000.
The updated rule takes effect on July 1. It was approved by a vote of three to one with one commissioner abstaining.
Read More..

Vatican takes first spot in Internet domain name draw

The Vatican has come out in first place in a long-awaited draw to expand the Internet address system with new domain names that go beyond the usual .com, .org or .net endings.
ICANN, the corporation that oversees the Internet address system, announced this week the domain name .catholic written in Chinese characters will be the first bid it considers in a drive to expand and reorganize sites on the World Wide Web.
The same extension in Arabic letters ranked 25th in the random draw and the Vatican's application for a version in Cyrillic for Russian and other Slavic languages came in 96th.
Ranking high means the applicant could get approval early next year to operate the new domain and approve addresses using it. In the Vatican's case, Rome could then ensure only genuine Roman Catholic institutions get to use that domain name.
"This is a way to give a coherence and authentication to our presence in the digital arena," said Monsignor Paul Tighe, secretary of the Pontifical Council for Social Communications.
"Anyone looking online will recognize the site belongs to an institution that belongs to the Catholic Church," he said, adding the new, so-called top level domain names (|TLDs) could also help speed online searches.
.BIBLE AND .ISLAM
For online retailers such as Amazon, whose application for .store in Japanese came in second, early approval could mean a competitive advantage and prompt a quick introduction of the new name.
But the Vatican did not enter the draw for commercial reasons and would not rush to launch its TLDs, Tighe said. In addition, the main TLD it seeks - .catholic in Latin letters - ended up in 1,366th place and may take months before it is approved.
Website owners are now restricted to a few dozen TLDs such as .com and country code domains such as .co.uk or .fr. Many of the 1,930 applications for new TLDs came from companies, including Internet giants such as Amazon and Google.
Several other faith-based groups applied for other TLDs such as .bible or .islam. The extension .mormon was the next-highest religious application drawn, coming in at 118th place.
ICANN (www.icann.org), the Internet Corporation for Assigned Names and Numbers, has stressed that assigning a certain TLD does not imply any endorsement of the religious group seeking it, just recognition it is the best suited to use the name.
Tighe said the ICANN draw handled applications for TLDs in non-Latin alphabets first, which explained why the Vatican's Chinese, Arabic and Cyrillic extensions came out far ahead of its main TLD in Latin letters.
INTERNET IMPRIMATUR
ICANN invited comments on applications earlier this year. The Vatican's application for exclusive use of .catholic drew criticism from members of several Protestant churches that also use the term, which comes from the Greek for "universal".
"This request is a move by a powerful group to squelch the voices and rights of other Christians," Dave Daubert, pastor of Zion Lutheran Church in Elgin, Illinois, wrote on the ICANN webpage for comments on the applications.
Saudi Arabia, the birthplace of Islam, apparently saw no hope of a consensus on religious TLDs and opposed them all.
Some religions seem to have kept out of the fray entirely. There were no applications for .buddhist, .hindu or .jewish.
Read More..

Vatican says pope beats Justin Bieber on re-tweets

Pope Benedict, white-haired, 85, and a neophyte to social media site Twitter, has beaten out 18-year old heartthrob Justin Bieber to set a percentage record for re-tweeting by his followers, the Vatican said on Thursday.
The Vatican newspaper said that as of noon Italian time on Thursday the pope had 2.1 million followers on Twitter, eight days after his first tweet was sent.
While Canadian singer-songwriter Bieber has roughly 15 times as many followers - 31.7 million - the Vatican newspaper said Benedict had beaten Bieber on re-tweets.
It said about 50 percent of the pope's followers had re-tweeted his first tweet on December 12 while only 0.7 percent of Bieber's followers had re-tweeted one of the singer's most popular tweets on September 26, when he commented on the death by cancer of a six-year-old fan.
The Vatican said this was part of a wider trend in which people were looking for more spiritual content.
The pope already tweets in English, German, Italian, French, Spanish, Portuguese, Polish and Arabic. The newspaper said he will start tweeting in Latin and Chinese soon.
Read More..