After nearly two decades of study, the Food and Drug Administration announced rules Thursday designed to make sure that infant formula is safe and nutritious.
Most formula makers already abide by the practices, but the FDA now will have rules on the books that ensure formula manufacturers test their products for salmonella and other pathogens before distribution. The rules also require formula companies to prove to the FDA that they are including specific nutrients — proteins, carbohydrates, fats, vitamins and minerals — in their products.
It is already law that formula must include those nutrients, which help babies stay healthy. But the new rules will help the FDA keep tabs on companies to make sure they are following the law. The rule would require manufacturers to provide data to the FDA proving that their formulas support normal physical growth and that ingredients are of sufficient quality.
“The FDA sets high quality standards for infant formulas because nutritional deficiencies during this critical time of development can have a significant impact on a child’s long-term health and well-being,” Michael Taylor, the FDA’s deputy commissioner for foods, said.
The rules also are aimed at new companies that come into the market. In recent years, grocery store aisles have become even more crowded with new kinds of formula, some capitalizing on natural or organic food trends.
The agency said breastfeeding is strongly recommended for newborns but that 25 percent of infants start out using formula. By three months, two-thirds of infants rely on formula for all or part of their nutrition.
The FDA doesn’t approve formulas before they are marketed but formula manufacturers must register with the agency. The FDA also conducts annual inspections of facilities that manufacture infant formula — far more often than the agency does inspections of other food facilities.
Dr. Stephen Ostroff, chief medical officer of the FDA’s Office of Foods and Veterinary Medicine, says the rules will help the agency enforce the law if it inspects a facility or looks at a company’s records and find problems. He said the rules were stalled for so many years — they were first proposed in 1996 — as the agency was keeping up with science that became available on food safety and other related issues.
Congress passed the Infant Formula Act in 1980 after a major manufacturer reformulated some of its formula products and omitted salt. A year later, infants who had eaten the formula were diagnosed with a chloride deficiency. The act required formula makers to use specific nutrients.
Over the years, infants occasionally have been diagnosed with cronobacter, one of the pathogens formula makers will now be required to test for and that is linked to infant formula. Found in the environment, hospitals and homes, cronobacter can multiply when formula sits out between feedings. It has only been found once in an unopened powdered formula, in 2002.
In 2011, the FDA and the federal Centers for Disease Control and Prevention tested infant formulas for cronobacter after four infants were infected with the pathogen in four states, and two of those infants died. They found no cronobacter in unopened cans of formula and were unable to link the cases to each other.
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Across America the government’s work is piling up, and it’s not just paperwork. It’s old tires and red Solo cups littering a stretch of river in Nebraska. Food poisoning microbes awaiting analysis in Atlanta. The charred wreckage of a plane in California, preserved in case safety investigators return.
And it’s the dead eagle in Wendi Pencille’s freezer.
Pencille tends to injured birds in her upstate New York home. When a bald eagle dies, she sends the federally protected remains to a special eagle repository near Denver that ships feathers and carcasses to Indian tribes for their sacred ceremonies.
But the federal bird shippers are on furlough while much of the U.S. government, like her fallen eagle, is on ice.
“I couldn’t send it, because it would just rot in a mailbox somewhere,” said Pencille. So the volunteer wildlife rehabilitator put the 9-pound bird in the freezer alongside food for the owls, hawks and two live eagles recovering at her Medina home.
“I’d like to get it out of there,” Pencille said. “We definitely need the space.”
Toxic waste is on hold at the Environmental Protection Agency’s Superfund sites, although work continues at those deemed an imminent threat to human life. The federal shutdown is fouling up some state and local clean-ups, too. For example, volunteers ready to pick up trash on sandbars and islands along 39 miles of the Missouri River in northeast Nebraska were told to stand down when they lost the use of federal boats.
The Labor Department delayed its monthly count of how many people are looking for work, which was due Friday and highly anticipated by stock traders. The Agriculture Department stopped cranking out tallies of livestock auctions and crop yields, which are vital numbers to farmers and buyers. The Centers for Disease Control isn’t tracking the nation’s flu cases, just as the season is getting started.
Other diseases are going unmonitored, too, such as microbes that could signal a multi-state outbreak of food poisoning.
The staff of 80 that normally analyze foodborne pathogens sent by states has been furloughed down to two. They are concentrating on looking for the biggies, such as possible salmonella, E. coli or listeria outbreaks. Other germs, including shigella and campylobacter, go ignored for now.
“The blind spots are getting bigger every day as this goes on,” said CDC spokeswoman Barbara Reynolds in Atlanta.
Timber will wait to be felled if the shutdown lasts much longer, since the Forest Service is starting the shutdown of logging operations this week. IRS refunds and farm subsidy checks are backing up. The future is on hold for some immigrants, because hearings that could lead to their deportation have been postponed.
The somber work of federal safety investigators has nearly come to a standstill.
Almost all of the board’s 400 employees were furloughed, NTSB spokeswoman Kelly Nantel said. Investigators examining a train collision in Chicago were kept on the job, however, because of urgent safety concerns raised by that accident.
Compared with what furloughed federal workers must deal with, the eagle in her freezer is just an inconvenience, Pencille, president of the Bless the Beasts Foundation, said Friday.
A bigger worry for her: What will happen to wounded eagles and ospreys in the nearby Iroquois National Wildlife Refuge while the shutdown keeps hunters and birdwatchers out?
“Without people over there,” Pencille said of the birds, “if they get injured, nobody is going to find them.”
Associated Press writers Mary Claire Jalonick and Joan Lowy in Washington and Justin Pritchard in Los Angeles contributed to this report.
Online: Bless the Beasts Foundation: http://blessthebeastsinc.webs.com
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A government shutdown would have far-reaching consequences for some, but minimal impact on others. The mail would still be delivered and Social Security and Medicare benefits would continue to flow. But vacationers would be turned away from national parks and Smithsonian museums. Low-to-moderate income borrowers and first-time homebuyers seeking government-backed mortgages could face delays.
Here’s how services would — or would not — be affected if Congress fails to reach an agreement averting a government shutdown at midnight Monday.
Federal air traffic controllers would remain on the job and airport screeners would keep funneling passengers through security checkpoints. Federal inspectors would continue enforcing safety rules.
The State Department would continue processing foreign applications for visas and U.S. applications for passports, since fees are collected to finance those services. Embassies and consulates overseas would continue to provide services to American citizens.
Social Security and Medicare benefits would keep coming, but there could be delays in processing new disability applications. Unemployment benefits would still go out.
Federal courts would continue operating normally for about 10 business days after the start of a shutdown, roughly until the middle of October. If the shutdown continues, the judiciary would have to begin furloughs of employees whose work is not considered essential. But cases would continue to be heard.
Deliveries would continue as usual since the U.S. Postal Service receives no tax dollars for day-to-day operations. It relies on income from stamps and other postal fees to keep running.
All national parks from Acadia National Park in Maine to Yosemite National Park in California would be closed, as would the Smithsonian museums, including the National Zoo in Washington. Visitors using overnight campgrounds or other park facilities would be given 48 hours to make alternate arrangements and leave the park. Among the visitor centers that would be closed: the Statue of Liberty and Ellis Island in New York, Independence Hall in Philadelphia, Alcatraz Island near San Francisco and the Washington Monument.
New patients would not be accepted into clinical research at the National Institutes of Health, but current patients would continue to receive care. Medical research at the NIH would be disrupted and some studies would be delayed. The Centers for Disease Control and Prevention would be severely limited in spotting or investigating disease outbreaks, from flu to that mysterious MERS virus from the Middle East.
The Food and Drug Administration would handle high-risk recalls suspend most routine safety inspections. Federal meat inspections would be expected to proceed as usual.
A small number of Head Start programs, about 20 out of 1,600 nationally, would feel the impact right away. The federal Administration for Children and Families says grants expiring around Oct. 1 would not be renewed. Over time more programs would be affected. Several of the Head Start programs that would immediately feel the pinch are in Florida. It’s unclear if they would continue serving children.
School lunches and breakfasts would continue to be served, and food stamps, known as the Supplemental Nutrition Assistance Program, or SNAP, would continue to be distributed. But several smaller feeding programs would not have the money to operate.
Americans would still have to pay their taxes and file federal tax returns, but the Internal Revenue Service says it would suspend all audits. Got questions? Sorry, the IRS says taxpayer services, including toll-free help lines, would be shut as well.
Many low-to-moderate incomes borrowers and first-time homebuyers seeking government-backed mortgages could face delays during the shutdown. The Federal Housing Administration, which guarantees about 30 percent of home mortgages, wouldn’t underwrite or approve any new loans during the shutdown. Action on government-backed loans to small businesses would be suspended.
NASA will continue to keep workers at Mission Control in Houston and elsewhere to support the International Space station, where two Americans and four others are deployed. The National Weather Service would keep forecasting weather and issuing warnings and the National Hurricane Center would continue to track storms. The scientific work of the U.S. Geological Survey would be halted.
The majority of the Department of Homeland Security’s employees are expected to stay on the job, including uniformed agents and officers at the country’s borders and ports of entry, members of the Coast Guard, Transportation Security Administration officers, Secret Service personnel and other law enforcement agents and officers. U.S. Citizenship and Immigration Services employees would continue to process green card applications.
The military’s 1.4 million active duty personnel would stay on duty, but their paychecks would be delayed. About half of the Defense Department’s civilian employees would be furloughed.
All 116 federal prisons would remain open, and criminal litigation would proceed.
Most services offered through the Department of Veterans Affairs will continue because lawmakers approve money one year in advance for the VA’s health programs. Veterans would still be able to visit hospitals for inpatient care, get mental health counseling at vet centers or get prescriptions filled at VA health clinics. Operators would still staff the crisis hotline and claims workers would still process payments to cover disability and pension benefits. But those veterans appealing the denial of disability benefits to the Board of Veterans Appeals will have to wait longer for a decision because the board would not issue any decisions during a shutdown.
Federal occupational safety and health inspectors would stop workplace inspections except in cases of imminent danger.
Associated Press writers Matthew Daly, Frederic J. Frommer, Kevin Freking, Andrew Miga, Deb Riechmann, Lauran Neergaard, Ricardo Alonso-Zaldivar, Mark Sherman, Stephen Ohlemacher, Lolita Baldor, Jesse Holland, Seth Borenstein, Mary Clare Jalonick and Alicia Caldwell contributed to this report.
A new bird flu strain that has killed 22 people in China is “one of the most lethal” of its kind and transmits more easily to humans than another strain that has killed hundreds since 2003, a World Health Organization (WHO) expert said on Wednesday.
The H7N9 flu has infected 108 people in China since it was first detected in March, according to the Geneva-based WHO.
Although it is not clear exactly how people are being infected, experts say they see no evidence so far of the most worrisome scenario – sustained transmission between people.
An international team of scientists led by the WHO and the Chinese government conducted a five-day investigation in China, but said they were no closer to determining whether the virus might become transmissible between people.
“The situation remains complex and difficult and evolving,” said Keiji Fukuda, the WHO’s assistant director-general for health security.
“When we look at influenza viruses, this is an unusually dangerous virus for humans,” he said at a briefing.
Another bird flu strain – H5N1 – has killed 30 of the 45 people it infected in China between 2003 and 2013, and although the H7N9 strain in the current outbreak has a lower fatality rate to date, Fukuda said: “This is definitely one of the most lethal influenza viruses that we’ve seen so far.”
Scientists who have analyzed genetic sequence data from samples from three H7N9 victims say the strain is a so-called “triple reassortant” virus with a mixture of genes from three other flu strains found in birds in Asia.
Recent pandemic viruses, including the H1N1 “swine flu” of 2009/2010, have been mixtures of mammal and bird flu – hybrids that are more likely to be milder because mammalian flu tends to make people less severely ill than bird flu.
Pure bird flu strains, such as the new H7N9 strain and the H5N1 flu, which has killed about 371 of 622 the people it has infected since 2003, are generally more deadly for people.
The team of experts, who began their investigation in China last week, said one problem in tracking H7N9 is the absence of visible illness in poultry.
Fukuda stressed that the team is still at the beginning of its investigation, and said that “we may just be seeing the most serious infections” at this point.
Based on the evidence, “this virus is more easily transmissible from poultry to humans than H5N1”, he said.
Besides the initial cases of H7N9 in and around Shanghai, others have been detected in Beijing and five provinces. On Wednesday, Taiwan’s Health Department said a businessman had contracted H7N9 while travelling in China and was in a serious condition in hospital.
Samples from chickens, ducks and pigeons from poultry markets have tested positive for H7N9, but those from migratory birds have not, suggesting that “the likely source of infection is poultry”, said Nancy Cox, director of the influenza division at the U.S. Centers for Disease Control and Prevention.
John Oxford, a flu virologist at Queen Mary University of London, said the emergence of human H7N9 infections – a completely new strain in people – was “very, very unsettling”.
“This virus seems to have been quietly spreading in chickens without anyone knowing about it,” he told Reuters in London.
Flu experts say it is likely that more cases of human infection with H7N9 flu will emerge in the coming weeks and months, at least until the source of infection has been completely confirmed and effectively controlled.
Anne Kelso, the Melbourne-based director of the WHO Collaborating Centre for Reference and Research on Influenza said there has been a “dramatic slowdown of cases” in the commercial capital of Shanghai, which has recorded most of the deaths, something she described as “encouraging”.
After Shanghai closed down its live poultry markets in early April, there was an almost immediate decline in new H7N9 cases, she said. “The evidence suggests that the closing of the live poultry markets was an effective way to reduce the risks.”
Even so, the WHO’s China representative, Michael O’Leary, issued figures last week showing that half of the patients analyzed had no known contact with poultry.
Copyright 2013 Thomson Reuters. All rights reserved.
Health officials are baffled as to why this is so. But the findings help explain why so many older people have been hospitalized with the flu this year.
Despite the findings, the CDC stood by its recommendation that everyone over 6 months get flu shots, the elderly included, because some protection is better than none, and because those who are vaccinated and still get sick may suffer less severe symptoms.
“Year in and year out, the vaccine is the best protection we have,” said CDC flu expert Dr. Joseph Bresee.
Overall, across the age groups studied, the vaccine’s effectiveness was found to be a moderate 56 percent, which means those who got a shot have a 56 percent lower chance of winding up at the doctor with the flu. That is somewhat worse than what has been seen in other years.
For those 65 and older, the vaccine was only 27 percent effective against the three strains it is designed to protect against, the worst level in about a decade. It did a particularly poor job against the tough strain that is causing more than three-quarters of the illnesses this year.
It is well known that flu vaccine tends to protect younger people better than older ones. Elderly people have weaker immune systems that don’t respond as well to flu shots, and they are more vulnerable to the illness and its complications, including pneumonia.
But health officials said they don’t know why this year’s vaccine did so poorly in that age group.
One theory, as yet unproven, is that older people’s immune systems were accustomed to strains from the last two years and had more trouble switching gears to handle this year’s different, harsh strain.
The preliminary data for senior citizens is less than definitive. It is based on fewer than 300 people scattered among five states.
But it will no doubt surprise many people that the effectiveness is that low, said Michael Osterholm, a University of Minnesota infectious-disease expert who has tried to draw attention to the need for a more effective flu vaccine.
Among infectious diseases, flu is considered one of the nation’s leading killers. On average, about 24,000 Americans die each flu season, according to the CDC.
This flu season started in early December, a month earlier than usual, and peaked by the end of year. Hospitalization rates for people 65 and older have been some of the highest in a decade, at 146 per 100,000 people.
Flu viruses tend to mutate more quickly than others, so a new vaccine is formulated each year to target the strains expected to be the major threats. CDC officials have said that in formulating this year’s vaccine, scientists accurately anticipated the strains that are circulating this season.
Because of the guesswork involved, scientists tend to set a lower bar for flu vaccine. While childhood vaccines against diseases like measles are expected to be 90 or 95 percent effective, a flu vaccine that’s 60 to 70 percent effective in the U.S. is considered pretty good. By that standard, this year’s vaccine is OK.
For senior citizens, a flu vaccine is considered pretty good if it’s in the 30 to 40 percent range, said Dr. Arnold Monto, a University of Michigan flu expert.
A high-dose version of the flu shot was recently made available for those 65 and older, but the new study was too small to show whether that has made a difference.
The CDC estimates are based on about 2,700 people who got sick in December and January. The researchers traced back to see who had gotten shots and who hadn’t. An earlier, smaller study put the vaccine’s overall effectiveness at 62 percent, but other factors that might have influenced that figure weren’t taken into account.
The CDC’s Bresee said there is a danger in providing preliminary results because it may result in people doubting — or skipping — flu shots. But the figures were released to warn older people who got shots that they may still get sick and shouldn’t ignore any serious flu-like symptoms, he said.
CDC report: http://www.cdc.gov/mmwr
Copyright 2013 The Associated Press. All rights reserved.
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.
Many Americans seem to be in a sour mood as 2013 begins, after Hurricane Sandy ravaged parts of the East Coast, a gunman massacred 20 school children in Connecticut and a long, contentious election campaign was followed by failure to resolve the “fiscal cliff” issue by year-end.
Americans have not been very optimistic since the Great Recession of 2008-2009, but the gloom had begun to lift this year until the blast of bad news as 2012 ended, IPSOS pollster Cliff Young said on Monday. IPSOS polling showed that some angst set in as the year ended.
Sixty-eight percent of respondents said the economy was on the wrong track at the end of 2012, IPSOS said, and 64 percent had a negative opinion of national politics.
“I do think these events had some sort of effect on people’s short-term prospects,” Young said.
But the headlines of 2012 belie a number of positive underlying trends in America, and Young said he expects public opinion to turn more positive in the new year.
Here is a summary of some of the positive trends in health, health, security, the environment, personal finance and education:
COLLEGE EDUCATION: More than 30 percent of Americans 25 years of age or older have finished four years of college, the highest level since 1940. Another 26 percent of adults have completed one to three years of college such as a community college, according to Census Bureau data.
This is important because the lifetime earnings of a person with a college associate’s degree working from age 25 to 64 will be $442,000 more than that of a high school graduate. A bachelor’s degree could yield $1 million more in lifetime earnings, a Census Bureau study found.
CONSUMER DEBT: While Americans are known as big spenders on credit, some surveys show that since the Great Recession of 2008-09, consumers are becoming more frugal. The average consumer with an account had credit card debt of $5,371 in November, 2012, down from $6,503 the same month a year ago, according to consumer organization Credit Karma. Average mortgage and auto debt also was down and even student loan debt, which has been rising, inched lower in November.
The end of the year usually brings increases in credit card debt due to holiday shopping, but consumers seem to be spending more responsibly and paying more with cash. Spending has been more conservative in general over the last four years since the recession, and credit card companies are lowering debt limits, Credit Karma said.
CHARITABLE GIVING: Despite the uncertain economy, Americans continue to be generous to charities. Donations rose to $298.42 billion in 2011, the highest since the Great Recession, although giving has not yet reached pre-recession levels.
Giving by Americans increased 4 percent in 2011 compared with 2010, with individual donations accounting for nearly three-quarters of the total, according to the 57th annual report by the Giving USA Foundation and the Center on Philanthropy at Indiana University.
Corporate donations remained flat at $14.5 billion last year, foundations made almost $42 billion in grants – an increase of 1.8 percent – while gifts from estates jumped more than 12 percent to $24.4 billion.
The money went to around 1.1 million registered charities and some 222,000 American religious groups.
Religious groups received the most donations – about one- third of the total – but dropped 1.7 percent in 2011 to $95.8 billion. The only other sector to record a drop in donations was giving to foundations, which fell 6.1 percent to $25.8 billion.
CANCER: Cancer claims the lives of more than half a million Americans every year and is the second leading cause of death after heart disease. But the numbers of deaths and people afflicted with the disease continue to decline, according to the Centers for Disease Control and Prevention. While the latest data is for 2008, officials said the trend continued in more recent years.
The federally funded CDC attributes the decline to identifying populations with unhealthy sedentary lifestyles and obesity, and intervening in a targeted way to improve their health and prevent cancer.
The highest rate of cancer deaths in the United States is for lung cancer, followed by prostate, breast cancer among women, colon, pancreatic, ovarian cancer and leukemia.
While lung cancer causes a greater rate of deaths, it is not the most frequent cancer. More Americans contract prostate cancer than any other type of the disease, followed by women with breast cancer. Lung cancer is third, followed by colon cancer, women with cancer of the uterus, and urinary bladder cancer.
SMOKING: The number of Americans who smoke continues to gradually decline, to 19 percent of adults over 18 in 2011, the latest year for which statistics are available, from 19.3 percent in 2010. The news is even better for young adults: the rate of smoking among 18- to 24-year-olds dropped to 18.9 percent in 2011 from 24.4 percent in 2005.
The best trend of all is that four out of five teenagers do not smoke, and teen smoking has been on the decline since 2000, although the rate of decline has slowed.
Fewer people addicted to tobacco means lower health costs and fewer deaths, such as from lung cancer, down the road, according to the CDC.
TEEN PREGNANCY: The number of births to girls aged 15 to 19 fell 8 percent in 20ll to a record low level. Teens seems to be less sexually active and more of those who are active seem to be using birth control, the CDC said.
CHILD OBESITY: After years of grim news about Americans getting fatter and sedentary, overweight children fixated on video games, the first signs of hope emerged this year. The CDC said new data showed a “modest” decline in child obesity in recent years. Two possible reasons – higher rates of breastfeeding and rising awareness of the importance of physical activity among young kids. A CDC study found 13 percent of preschoolers surveyed were obese in 1998, growing to 15 percent in 2003, but again falling below 15 percent by 2010, the most recent study year.
DRINKING AND DRIVING: The incidence of Americans driving after drinking too much has declined by 30 percent over the past 5 years although it remains a serious problem. Four-in-five drunk drivers are men and especially men from ages 21 to 34.
The best news is that drinking and driving among teenagers has fallen 54 percent since 1991. Only about 10 percent of teens ages 16 years or older had driven after drinking in 2011 compared with more than 20 percent two decades ago.
The reasons for this success include a minimum drinking age of 21 in all states, zero tolerance laws, graduated drivers’ license systems and better parental monitoring, according to the CDC.
LAW ENFORCEMENT DEATHS: Deaths of law enforcement officials in the line of duty fell by 23 percent in 2012 after two years of sharp increases. Some 127 federal, state and local officers were killed, with traffic accidents the top cause of death, followed by shootings.
While national headlines have regularly featured terrible shootings such as those at an elementary school in Newtown, Connecticut and a movie theater in Aurora, Colorado, the number of police officers killed in shootings fell 32 percent in 2012.
AIR QUALITY: In 2010, about 90 million tons of pollution were emitted into the atmosphere in the United States, according to the Environmental Protection Agency. These emissions form ozone and particles, reduce visibility and deposition of acids, and visibility impairment.
But the good news is that pollution in the air we breathe is down substantially in all categories. In the three decades since 1980, emissions of carbon monoxide from cars, ozone, lead, nitrogen, sulfur and particulate matter such as soot all have declined. Carbon monoxide is down 82 percent, lead down 90 percent, nitrogen down 52 percent and sulfur declined 76 percent.
TRASH: Americans generated about 250 million tons of trash in 2010, most of which fouls the environment or goes into landfills. We may be starting to reform our wasteful ways, according to data from the EPA. The amount of waste generated per person per day had declined to 4.43 pounds by 2010 from 4.67 pounds five years earlier, according to the EPA.
Another positive trend is that recycling is increasing. Of the 250 million tons of trash produced in 2010, more than 85 million tons or 34.1 percent was recycled or composted.
Lawmakers on Friday widened their investigation into the deadly meningitis outbreak to include the role state regulators played in monitoring the pharmacy that produced steroid treatments blamed for killing 14 people in six states.
The U.S. House of Representatives‘ Energy and Commerce Committee called on the Massachusetts pharmacy board to tell congressional staff what it knew about the New England Compounding Center before the recall of more than 17,000 vials of injectable steroid treatments for back and joint pain from health facilities in 23 states.
Separately, New England Compounding, which voluntarily gave up its license in Massachusetts after it was identified as the likely source of the outbreak, started to shed employees.
The suburban Boston company has cut more than half of its workforce, or about 40 employees.
New England Compounding, which had been licensed in 49 states, is expected to face a torrent of regulatory action and lawsuits.
As past regulatory actions came into focus the U.S. House panel, which oversees health issues including drug safety, said the U.S. Food and Drug Administration was aware of production problems at Framingham, Massachusetts-based firm in 2006, including potential public health risks involving a different sterile injectable drug.
The rare fungal form of meningitis has now infected 184 people in 12 states, with Texas reporting its first case on Friday.
The outbreak is a major national health scandal, with multiple investigations under way and a leading Democratic lawmaker, Senator Richard Blumenthal of Connecticut, calling for a criminal investigation of the company.
The House committee asked the Massachusetts regulator to agree to a briefing no later than October 19 and requested all inspection reports, records and communications related to New England Compounding Center (NECC) and its sister pharmacy, Ameridose LLC, which has the same owners.
“The committee is investigating whether any remedial measures were taken after this inspection and why the NECC was able to continue operating in this manner more than six years after the fact,” Republican Fred Upton, the committee chairman, said in a letter co-authored by six other panel members.
The Massachusetts agency did not comment directly on the committee’s request for information, but the state health department said that it had taken swift action in response to the meningitis outbreak.
The specialist pharmacy appears to have violated the licensing regulation that restricted their production to the receipt of “individual patient-specific prescriptions,” the department said in a statement. “We are jointly examining all root causes of these events with the FDA.”
Late on Friday, Michigan suspended the company’s license in the state, which is among the hardest hit in the outbreak.
Attorney General Bill Schuette’s office alleged that the specialist pharmacy was acting as a drug manufacturer – distributing large amounts of medication to hospitals and clinics – while licensed only to fill individual prescriptions for patients in the state.
FDA WANTS EXPANDED OVERSIGHT
Lawmakers and organizations including the advocacy group Public Citizen have raised questions about whether the FDA and Massachusetts regulators had the knowledge and authority to act against New England Compounding before the outbreak occurred.
The compounding company has recalled the suspect product, surrendered its operating license and has said it is cooperating with the investigations.
The regulatory issue involves a little-known segment of the pharmacy industry called drug-compounding, in which pharmacists alter or recombine ingredients from FDA-approved drugs to meet the special needs of doctors and their patients.
Pharmacies like NECC are allowed to compound drugs for specific prescriptions, mainly under the supervision of state pharmacy boards rather than the more stringent safety and efficacy standards that the FDA imposes.
FDA officials have called for a new regulatory framework, saying the agency’s power to oversee compounding pharmacies is limited, partly as the result of legal challenges that have popped up in courts across the country over more than a decade.
The House committee noted a 2006 FDA letter that said NECC’s actions were not consistent with traditional compounding practices and likened the operation to a drug manufacturer.
The CDC is working furiously to contain the meningitis outbreak from medications shipped to 23 states. Deaths have been reported in Tennessee, Florida, Michigan, Indiana, Maryland and Virginia.
Meningitis is an infection of the membranes covering the brain and spinal cord. Symptoms include headache, fever and nausea and it must be treated quickly to improve chances of survival. Fungal meningitis is a rare form and is not contagious.
(Reporting by David Bailey, Toni Clarke, Ros Krasny, Aaron Pressman, Grant McCool, and Tim Ghianni; Writing by Greg McCune; Editing by Lisa Shumaker and Bill Trott)
Copyright 2012 Thomson Reuters. All rights reserved.
The U.S. Centers for Disease Control and Prevention lost or misplaced more than $8 million in property in 2007, losing track of items including computer and video equipment, government auditors say.
Agency officials said Wednesday they have corrected the lapses that led to that amount of waste.
The report was released this week by the inspector general for the Department of Health and Human Services, the parent agency of the CDC. In 2007, the auditors checked on 200 randomly sampled items and found 15 were lost or not inventoried, including a $1.8 million hard disk drive and a $978,000 video conferencing system.
CDC Director Dr. Thomas Frieden wrote the inspector general that the CDC agrees with the report’s conclusions and has now instituted better controls. He wrote that 99 percent of the agency’s property was accounted for in 2009. And the agency says all of its property this year is accounted for.
The agency still hasn’t explained what happened to the 15 pieces of missing equipment from 2007, auditors said. But a CDC spokeswoman on Wednesday said all but four of the items — including the two most expensive ones — have since been accounted for.
“It’s just a good thing they haven’t lost any diseases,” Schatz said.
The Atlanta-based CDC often gets high marks for how well it does at its core mission of promoting health and investigating outbreaks of illness. But it has less incentive to keep track of its computer equipment or take care of other concerns that would seem important to a private business, Schatz said.
“There are a lot of agencies that do their job well, but they don’t manage the ‘little things’ very well. The Defense Department is notorious for losing all kinds of equipment, but they do a pretty good job defending the country,” Schatz said.
This is the CDC’s second audit. A 1995 audit found the agency was unable to account for more than $5.5 million in property, including computers, microscopes and even vehicles.
In 2007, two House Republicans — Joe Barton of Texas and Greg Walden of Oregon — asked the inspector general to take a new look at how CDC inventories and tracks its property, following allegations that as much as $22 million in CDC equipment had been lost or stolen.
The audit focused on the $350 million in equipment CDC had in fiscal year 2007. The report was delayed until now partly because of personnel changes within the inspector general’s office, auditors said.
Office of Inspector General report: http://www.oig.hhs.gov/oas/reports/region4/40701054.asp