FDA: New rules will make food safer


WASHINGTON (AP) — The Food and Drug Administration says its new guidelines would make the food Americans eat safer and help prevent the kinds of foodborne disease outbreaks that sicken or kill thousands of consumers each year.


The rules, the most sweeping food safety guidelines in decades, would require farmers to take new precautions against contamination, to include making sure workers' hands are washed, irrigation water is clean, and that animals stay out of fields. Food manufacturers will have to submit food safety plans to the government to show they are keeping their operations clean.


The long-overdue regulations could cost businesses close to half a billion dollars a year to implement, but are expected to reduce the estimated 3,000 deaths a year from foodborne illness. The new guidelines were announced Friday.


Just since last summer, outbreaks of listeria in cheese and salmonella in peanut butter, mangoes and cantaloupe have been linked to more than 400 illnesses and as many as seven deaths, according to the federal Centers for Disease Control and Prevention. The actual number of those sickened is likely much higher.


Many responsible food companies and farmers are already following the steps that the FDA would now require them to take. But officials say the requirements could have saved lives and prevented illnesses in several of the large-scale outbreaks that have hit the country in recent years.


In a 2011 outbreak of listeria in cantaloupe that claimed 33 lives, for example, FDA inspectors found pools of dirty water on the floor and old, dirty processing equipment at Jensen Farms in Colorado where the cantaloupes were grown. In a peanut butter outbreak this year linked to 42 salmonella illnesses, inspectors found samples of salmonella throughout Sunland Inc.'s peanut processing plant in New Mexico and multiple obvious safety problems, such as birds flying over uncovered trailers of peanuts and employees not washing their hands.


Under the new rules, companies would have to lay out plans for preventing those sorts of problems, monitor their own progress and explain to the FDA how they would correct them.


"The rules go very directly to preventing the types of outbreaks we have seen," said Michael Taylor, FDA's deputy commissioner for foods.


The FDA estimates the new rules could prevent almost 2 million illnesses annually, but it could be several years before the rules are actually preventing outbreaks. Taylor said it could take the agency another year to craft the rules after a four-month comment period, and farms would have at least two years to comply — meaning the farm rules are at least three years away from taking effect. Smaller farms would have even longer to comply.


The new rules, which come exactly two years to the day President Barack Obama's signed food safety legislation passed by Congress, were already delayed. The 2011 law required the agency to propose a first installment of the rules a year ago, but the Obama administration held them until after the election. Food safety advocates sued the administration to win their release.


The produce rule would mark the first time the FDA has had real authority to regulate food on farms. In an effort to stave off protests from farmers, the farm rules are tailored to apply only to certain fruits and vegetables that pose the greatest risk, like berries, melons, leafy greens and other foods that are usually eaten raw. A farm that produces green beans that will be canned and cooked, for example, would not be regulated.


Such flexibility, along with the growing realization that outbreaks are bad for business, has brought the produce industry and much of the rest of the food industry on board as Congress and FDA has worked to make food safer.


In a statement Friday, Pamela Bailey, president of the Grocery Manufacturers Association, which represents the country's biggest food companies, said the food safety law "can serve as a role model for what can be achieved when the private and public sectors work together to achieve a common goal."


The new rules could cost large farms $30,000 a year, according to the FDA. The agency did not break down the costs for individual processing plants, but said the rules could cost manufacturers up to $475 million annually.


FDA Commissioner Margaret Hamburg said the success of the rules will also depend on how much money Congress gives the chronically underfunded agency to put them in place. "Resources remain an ongoing concern," she said.


The farm and manufacturing rules are only one part of the food safety law. The bill also authorized more surprise inspections by the FDA and gave the agency additional powers to shut down food facilities. In addition, the law required stricter standards on imported foods. The agency said it will soon propose other overdue rules to ensure that importers verify overseas food is safe and to improve food safety audits overseas.


Food safety advocates frustrated over the last year as the rules stalled praised the proposed action.


"The new law should transform the FDA from an agency that tracks down outbreaks after the fact, to an agency focused on preventing food contamination in the first place," said Caroline Smith DeWaal of the Center for Science in the Public Interest.


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Abbas sees Palestinian unity as Fatah rallies in Gaza


GAZA (Reuters) - President Mahmoud Abbas predicted the end of a five-year split between the two big Palestinian factions as his Fatah movement staged its first mass rally in Gaza with the blessing of Hamas Islamists who rule the enclave.


"Soon we will regain our unity," Abbas, whose authority has been limited to the Israeli-occupied West Bank since the 2007 civil war between the two factions, said in a televised address to hundreds of thousands of followers marching in Gaza on Friday, with yellow Fatah flags instead of the green of Hamas.


The hardline Hamas movement, which does not recognize Israel's right to exist, expelled secular Fatah from Gaza during the war. It gave permission for the rally after the deadlock in peace talks between Abbas's administration and Israel narrowed the two factions' ideological differences.


The Palestinian rivals have drawn closer since Israel's assault on Gaza assault in November, in which Hamas, though battered, claimed victory.


Egypt has long tried to broker Hamas-Fatah reconciliation, but past efforts have foundered over questions of power-sharing, control of weaponry, and to what extent Israel and other powers would accept a Palestinian administration including Hamas.


An Egyptian official told Reuters Cairo was preparing to invite the factions for new negotiations within two weeks.


Israel fears grassroots support for Hamas could eventually topple Abbas's Palestinian Authority (PA) in the West Bank.


"Hamas could seize control of the PA any day," Israeli Prime Minister Benjamin Netanyahu said on Thursday.


The demonstration marked 48 years since Fatah's founding as the spearhead of the Palestinians' fight against Israel. Its longtime leader Yasser Arafat signed an interim 1993 peace accord that won Palestinians a measure of self rule.


Hamas, which rejected the 1993 deal, fought and won a Palestinian parliamentary election in 2006. It formed an uneasy coalition with Fatah until their violent split a year later.


Though shunned by the West, Hamas feels bolstered by electoral gains for Islamist movements in neighboring Egypt and elsewhere in the region - a confidence reflected in the fact Friday's Fatah demonstration was allowed to take place.


"The success of the rally is a success for Fatah, and for Hamas too," said Hamas spokesman Sami Abu Zuhri. "The positive atmosphere is a step on the way to regain national unity."


Fatah, meanwhile, has been riven by dissent about the credibility of Abbas's statesmanship, especially given Israel's continued settlement-building on West Bank land. The Israelis quit Gaza unilaterally in 2005 after 38 years of occupation.


"The message today is that Fatah cannot be wiped out," said Amal Hamad, a member of the group's ruling body, referring to the demonstration attended by several Abbas advisers. "Fatah lives, no one can exclude it and it seeks to end the division."


In his speech, Abbas promised to return to Gaza soon and said Palestinian unification would be "a step on the way to ending the (Israeli) occupation".


(Editing by Dan Williams, Alistair Lyon and Jason Webb)



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Tennis: Tsonga withdraws from Sydney event with injury






SYDNEY, Jan 5, 2013 (AFP) - French tennis star Jo-Wilfried Tsonga has withdrawn from next week's Sydney International with a hamstring injury, tournament organisers said on Saturday.

The world number eight pulled out of the last major lead-up event to this month's Australian Open after suffering the injury playing for France in the mixed teams Hopman Cup in Perth on Friday.

"Unfortunately Jo-Wilfried Tsonga sustained an injury in Perth and has been forced to pull out of the Apia International Sydney with a left hamstring injury," tournament director Craig Watson said.

"We wish him a speedy recovery and all the best for a successful Australian Open."

Tsonga became the second top seed to drop out of the Sydney event after French compatriot Richard Gasquet, the world number 10, pulled out for personal reasons, organisers said.

- AFP/fa



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Centre seeks proposals on CCTV inside state buses

NEW DELHI: Centre has asked the state public transport corporations to send proposals on installing CCTV cameras inside their buses and setting up of monitoring station for keep track of the bus movements even on rural routes. Based on their fund requirement, the Centre would step in to provide financial assistance for vehicle and passenger safety.

The proposal was made on Thursday at the executive committee meeting of Association of State Road Transport Undertakings (ARSTUs) under the chairmanship of Union road transport secretary AK Upadhyaya. Sources said that the ministry is keen to provide aid to the STUs under its scheme to implement IT initiatives for better functioning of government owned public buses.

"We will send our proposals. Installation of CCTVs inside buses to keep eye on the activities is a good move, but we need to have proper monitoring centres. Moreover you need to be linked to local police so that they can take action in case of an emergency," said a senior official of a state transport corporation from south India said. He added that most of the major STUs operating buses in cities are going for global positioning system (GPS).

Mumbai's BEST and Andhra's APSRTC are some of the main corporations which are showing interest in this regard. The need for GPS and monitoring has gained importance due to the recent national uprising for women safety.

Sources said in the past two fiscal years, the road transport ministry has sanctioned Rs 71 crore to 15 SRTUs for IT projects. These transport bodies are investing another Rs 71 crores to implement the projects. ARSTU officials said another 30-40 transport corporations want the tracking system and to have a monitoring centre.

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Obama Poised to Name New Defense, Treasury Chiefs













With the "fiscal cliff" crisis behind him, President Obama is poised to name two new key players to his cabinet, with both announcements expected to come next week.


Obama will name the replacement for outgoing Defense Secretary Leon Panetta as soon as Monday, sources told ABC News. Former Republican Sen. Chuck Hagel is the likely nominee, they said.


Meanwhile, the president is also eyeing a replacement for outgoing Treasury Secretary Timothy Geithner, the longest-serving member of Obama's first-term economic team and one-time lead negotiator for the administration in the "fiscal cliff" talks.


Current chief of staff Jack Lew is all but certain to get the nod for Treasury, according to people familiar with Obama's thinking.


A White House spokesman cautioned that the president has not yet made a final decision on either post, calling reports about Hagel and Lew "merely guessing."


Still, when Obama returns from his Hawaiian vacation on Sunday, he's expected to waste little time filling out his team for a second term.


Geithner has said he would remain at his post "until around the inauguration" Jan. 20, a Treasury spokesperson said Thursday, putting the department potentially in transition just as the administration confronts the next financial "cliffs" over automatic spending cuts and the nation's debt limit.






Brendan Hoffman/Getty Images











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During an appearance on ABC's "This Week" in April, Geithner said the next Treasury secretary would need to be someone who is "willing to tell [Obama] the truth and, you know, help him do the tough things you need to do."


Lew, a former two-time Office of Management and Budget director and trusted Obama confidant who has held the chief of staff role since early 2012, is the front-runner for the job.


Meanwhile, Sen. John Kerry -- Obama's nominee to replace outgoing Secretary of State Hillary Clinton -- has begun making more regular appearances at the U.S. State Department before his expected confirmation later this month.


His Senate hearings are set to begin shortly after Obama's inauguration, sources say. The administration still expects Clinton to testify about the Sept. 11 Benghazi, Libya, attacks before Kerry is confirmed.


But it is the potential nomination of Republican Hagel that has caused the most stir.


Critics from across the political spectrum have taken aim at the former senator from Nebraska's record toward Israel and what some have called a lack of experience necessary to lead the sprawling Pentagon bureaucracy or its operations. The controversy has set the stage for what would be a contentious confirmation process.


"A lot of Republicans and Democrats are very concerned about Chuck Hagel's position on Iran sanctions, his views toward Israel, Hamas and Hezbollah, and that there is wide and deep concern about his policies," Sen. Lindsey Graham, R-S.C., told "Fox News Sunday."


He would not say whether Republicans felt so strongly as to expect a filibuster of the nomination.


"I can tell you there would be very little Republican support for his nomination," Graham said. "At the end of the day, they will be very few votes."


Still, Hagel, 66, a former businessman and decorated veteran who served in the Vietnam War, has won praise and admiration from current and former diplomats for his work on Obama's Intelligence Advisory Board and Panetta's Policy Advisory Board.





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Indian court to rule on generic drug industry


NEW DELHI (AP) — From Africa's crowded AIDS clinics to the malarial jungles of Southeast Asia, the lives of millions of ill people in the developing world are hanging in the balance ahead of a legal ruling that will determine whether India's drug companies can continue to provide cheap versions of many life-saving medicines.


The case — involving Swiss drug maker Novartis AG's cancer drug Glivec — pits aid groups that argue India plays a vital role as the pharmacy to the poor against drug companies that insist they need strong patents to make drug development profitable. A ruling by India's Supreme Court is expected in early 2013.


"The implications of this case reach far beyond India, and far beyond this particular cancer drug," said Leena Menghaney, from the aid group Doctors Without Borders. "Across the world, there is a heavy dependence on India to supply affordable versions of expensive patented medicines."


With no costs for developing new drugs or conducting expensive trials, India's $26 billion generics industry is able to sell medicine for as little as one-tenth the price of the companies that developed them, making India the second-largest source of medicines distributed by UNICEF in its global programs.


Indian pharmaceutical companies such as Cipla, Cadila Laboratories and Lupin have emerged over the past decade as major sources of generic cancer, malaria, tuberculosis and AIDS drugs for poor countries that can't afford to pay Western prices.


The 6-year-old case that just wrapped up in the Supreme Court revolves around a legal provision in India's 2005 patent law that is aimed at preventing companies from getting fresh patents for making only minor changes to existing medicines — a practice known as "evergreening."


Novartis' argued that a new version of Glivec — marketed in the U.S. as Gleevec — was a significant change from the earlier version because it was more easily absorbed by the body.


India's Patent Controller turned down the application, saying the change was an obvious development, and the new medicine was not sufficiently distinct from the earlier version to warrant a patent extension.


Patient advocacy groups hailed the decision as a blow to "evergreening."


But Western companies argued that India's generic manufacturers were cutting the incentive for major drug makers to invest in research and innovation if they were not going to be able to reap the exclusive profits that patents bring.


"This case is about safeguarding incentives for better medicines so that patients' needs will be met in the future," says Eric Althoff, a Novartis spokesman.


International drug companies have accused India of disregarding intellectual property rights, and have pushed for stronger patent protection that would weaken India's generics industry.


Earlier this year, an Indian manufacturer was allowed to produce a far cheaper version of the kidney and liver cancer treatment sorefinib, manufactured by Bayer Corp.


Bayer was selling the drug for about $5,600 a month. Natco, the Indian company, said its generic version would cost $175 a month, less than 1/30th as much. Natco was ordered to pay 6 percent in royalties to Bayer.


Novartis says the outcome of the new case will not affect the availability of generic versions of Glivec because it is covered by a grandfather clause in India's patent law. Only the more easily absorbed drug would be affected, Althoff said, adding that its own generic business, Sandoz, produces cheap versions of its drugs for millions across the globe.


Public health activists say the question goes beyond Glivec to whether drug companies should get special protection for minor tweaks to medicines that others could easily have uncovered.


"We're looking to the Supreme Court to tell Novartis it won't open the floodgates and allow abusive patenting practices," said Eldred Tellis, of the Sankalp Rehabilitation Centre, a private group working with HIV patients.


The court's decision is expected to be a landmark that will influence future drug accessibility and price across the developing world.


"We're already paying very high prices for some of the new drugs that are patented in India," said Petros Isaakidis, an epidemiologist with Doctors Without Borders. "If Novartis' wins, even older medicines could be subject to patenting again, and it will become much more difficult for us in future to provide medicines to our patients being treated for HIV, hepatitis and drug resistant TB."


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Vice President Maduro back in Venezuela, no news on ailing Chavez


CARACAS (Reuters) - Vice President Nicolas Maduro returned to Venezuela on Thursday after visiting Hugo Chavez in hospital in Cuba, but gave no new details on the cancer-stricken president as rumors grow about his condition.


Flanked by senior government figures including Diosdado Cabello, the head of the National Assembly, Maduro toured a coffee production plant in Caracas - the type of visit that the president made frequently before he fell ill.


Chavez, 58, has not been seen in public nor heard from in more than three weeks and officials say the socialist leader is in delicate condition after suffering complications following his fourth cancer operation in just 18 months. But they have offered very few details.


"In the last few hours we were with President Hugo Chavez, bringing him the encouragement and strength of the Venezuelan people," Maduro said on Thursday. He said Cabello, Oil Minister Rafael Ramirez and Chavez's elder brother Adan, among others, had all been with the president in the Cuban hospital.


Venezuelan bonds rallied to 2008 highs on Thursday on rumors about Chavez's health.


In scenes that recalled Chavez's hours-long televised visits to building sites, hospitals and oil refineries, Maduro told workers at the nationalized Fama de America factory that there was no "transition" taking place in the country.


"The only transition in Venezuela is the transition to socialism," he said in comments carried live by state television.


"It began six years ago, ordered by Comandante Hugo Chavez as chief and president, elected, re-elected and ratified, much as it pains the bourgeois hucksters and the right, who have done so much damage to our fatherland."


Chavez's abrupt exit from the political scene would be a huge shock for the South American OPEC nation. His oil-financed socialism has made him a hero to the poor majority but critics call him a dictator.


He is still set to be sworn in on January 10, as spelled out in the constitution. If he were to die or had to step aside, new elections would be held within 30 days, with Maduro running as the ruling Socialist Party candidate.


Chavez's condition is being watched closely by Latin American allies that have benefited from his generous assistance, as well as Wall Street investors who are attracted to Venezuela's lucrative and widely traded debt.


Last year, Chavez staged what appeared to be remarkable comeback from the disease to win re-election to a new six-year term in October despite being weakened by radiation therapy. But he returned to Cuba for more treatment within weeks of his win.


Officials have said he suffered unexpected bleeding and then a respiratory infection after a six-hour operation on December 11.


Top Socialist Party officials have suggested that his inauguration could be postponed indefinitely to accommodate his recovery.


The opposition has insisted that the government should stick to the January 10 date, and on Thursday one opposition leader said they should form an official commission to visit Cuba and assess the president's condition for themselves.


(Editing by Kieran Murray and Lisa Shumaker)



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Australian soy milk action widened to Japanese firms






SYDNEY: Hundreds of Australians who became sick after drinking soy milk containing dangerously high levels of iodine have widened their class action to include two Japanese companies, lawyers said.

About 600 Australians became ill after consuming Bonsoy milk, many suffering thyroid problems, up until the product was withdrawn from sale in late 2009, Maurice Blackburn Lawyers said late Thursday.

The case against the Australian brand owner Spiral Foods launched in the Victorian Supreme Court in 2010 had been widened to include manufacturer Marusan-ai Co Ltd and exporter Muso Co Ltd, the firm said.

"We say that these three companies had test results in mid-2006 which showed that Bonsoy contained extremely high levels of iodine, but they did nothing," said senior associate Irina Lubomirska in a statement.

Lubomirska said the companies had breached consumer protection laws in Australia and Japan.

"None of the three companies did anything to ensure that Bonsoy, which was marketed and sold as a premium health-food soy brand, was in fact safe to consume," she said.

The class action alleges that Spiral requested a reformulation of Bonsoy to include iodine-rich kombu instead of adding salt and that as a result the product had contained excessive iodine since mid-2003.

It also alleges that consumer concerns about iodine were repeatedly dismissed.

Victims are seeking compensation for medical expenses and loss of income as well as for the pain and suffering.

By the time Bonsoy was recalled in late 2009, after Australian authorities discovered that one glass contained seven times the upper safe dose of iodine for adults, it had been on the market for six years, Maurice Blackburn said.

Because it was touted as a healthy product, some consumers had increased their intake when they became ill, Lubomirska added.

A directions hearing on the matter is scheduled for March 8.

-AFP/ac



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1 pilot, 3 airhostesses found drunk since Christmas

NEW DELHI: The fear of losing their flying licence led to pilots celebrating Yuletide and ushering in the New Year on a sober note this year. Authorities caught only one pilot — but three airhostesses — reporting to work in an inebriated state during breathalyser (BA) tests done at airports from Christmas to Wednesday.

All four flight personnel were from Jet Airways. "We have a zero tolerance policy for this issue and carry out strict BA tests. Whoever fails the tests is, as per DGCA guidelines, suspended for three months," said aJet spokesperson.

A DGCA official said two flight crew members failed the BA test in Chennai and one each in Delhi and Kochi. "The punishment is very severe now for pilots failing BA tests as their licence is suspended for three months when caught first time and for five years for the second time. This means end of flying career as a five-year suspension will lead to all eligibilities lapsing," he added.

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James Holmes Defense: Was He Insane?


Jan 3, 2013 5:30pm







James Holmes court appearance mr 120723 wblog James Holmes Defense Witnesses in Colorado Shooting to Testify on Mental State

James Holmes appears in court, Centennial, Colo., July 23, 2012. RJ Sangosti/AP Images.



ABC’s Clayton Sandell and Carol McKinley report:


A judge ruled Thursday that public defenders for accused Colorado theater shooting suspect James Holmes can call two unidentified witnesses at next week’s preliminary hearing to testify about the defendant’s “mental state.”


Arapahoe County, Colo. prosecutors had sought to keep the witnesses out of court, but Judge William Sylvester ruled that the now-25-year-old accused killer has a right to call the witnesses at a preliminary hearing.


The Jan. 7 preliminary hearing will essentially be a mini-trial in which prosecutors will present witness testimony and evidence to convince the judge that there is enough of a case against Holmes to proceed to a trial.


Witnesses to be called for the prosecution include the Aurora police lead detective, first responders, the Arapahoe County coroner and likely a computer forensic specialist, according to prosecution sources who declined to be identified, citing a gag order in the case.


A top priority, the prosecution sources say, will be showing that Holmes acted with premeditation when he allegedly murdered 12 people and wounded 58 on the night of July 20 during a midnight showing of “The Dark Knight Rises.”


Defense attorneys may pursue a legal strategy to show that Holmes was not in his right mind at the time of the shooting.


Holmes, who has not yet entered a plea, has been repeatedly described in court by his legal team as mentally ill. While a graduate student at the University of Colorado, he was in the care of a psychiatrist.


Prosecutors say they will also present photos, video and 911 calls during the hearing, which is expected to last all week.


It’s not clear what the two witnesses’ relationship is to the shooting, or to Holmes.


Prosecutors, Judge Sylvester’s order says, contend that “neither witness has personal knowledge of the events at the Century Aurora 16 Theater.”


Sylvester said the witnesses are non-expert “lay witnesses” who have so far chosen not to be interviewed by defense investigators but have been cooperating with law enforcement.



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