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After many years of delays, the agency said in August it would complete the first part of the dioxin reassessment, which would have set a toxicological threshold for the first time, by January 31.
The draft reassessment has been sharply criticized by the food industry for being too restrictive and being based on shaky science. Health and environmental groups expressed outrage at the continued delay.
"Shame on EPA Administrator Lisa Jackson for denying parents the information they need to protect their children from the health impacts of dioxin," said Lois Marie Gibbs, executive director of the Center for Health, Environment & Justice, a group among dozens pressuring EPA on the issue. "This is America -- parents have the right to know."
Dioxins are released into the air during certain industrial processes, like cement production and are also naturally occurring. According to new government data, air releases of dioxin rose 10 percent between 2009 and 2010. Dioxins are ingested by food animals, via grazing and contaminated feed, and are bioaccumulated -- a reality that has concerned regulators and public health authorities because dioxins are linked to reproductive and developmental problems, immune system damage and cancer.
The World Health Organization (WHO) estimates that 90 percent of human exposure to dioxins is via food, particularly meat, dairy, fish and shellfish. The food industry worries that the EPA reassessment would have recommended an exposure threshold that is lower than the level of exposure many Americans already face through their daily diet.
In December, the Food Industry Dioxin Working Group (FIDWG) -- an ad hoc coalition made up of groups like United Egg Producers, the American Farm Bureau and the American Frozen Food Institute -- sent a letter to a senior White House policy adviser expressing "deep concern" over the effort. The letter was also sent to key officials at the EPA, U.S. Department of Agriculture, Food and Drug Administration, Health and Human Services, and the White House Office of Management and Budget.
The EPA's acceptable level for dioxin exposure, otherwise known as a reference oral dose (RfD), is expected to be .7 picograms per kilogram of body weight per day. Similar thresholds set by the World Health Organization and the European Union are between 1-4 picograms per kilogram of bodyweight per day.
If EPA finalized an RfD for dioxin it would not be a regulatory action, but it could be used as the basis for future regulation and would likely fuel some people to alter their dietary choices.
As the food industry pointed out recently in a letter to the Obama administration, some common food items could easily put someone over the draft RfD.
"Under EPA's proposal...nearly every American - particularly young children - could easily exceed the daily RfD after consuming a single meal or heavy snack," according to the industry groups. "The implications of this action are chilling. EPA is proposing to create a situation in which most U.S. agricultural products could arbitrarily be classified as unfit for consumption. The impact on agricultural production - conventional, organic, livestock/poultry/dairy, fruits, grains and vegetables - may be significant, as will be the loss of trade markets, all without evidence of additional health protection."
The American Chemistry Council, which represents chemical companies, says that EPA needs to take more time to ensure the reassessment is based on sound science, and claims that the agency is "ignoring the most recent peer-reviewed science." Many lawmakers and advocates say the reassessment is years overdue and that further delays are the result of undue influence of industry.
Just how long has this reassessment been in the works? EPA first began work on assessing the risks of dioxin exposure in the 1980s. The most recent human health reassessment was submitted by EPA to the National Academy of Sciences (NAS) in 2003, during the Bush administration. In 2006, NAS submitted recommendations to EPA on the reassessment. In May 2010, the agency released a draft reanalysis and the agency says it's working expeditiously to get a final guidance out, but major industry opposition remains.
"The American public has been waiting for the completion of this dioxin study since 1985 and cannot afford any further delays," Rep. Edward Markey (D-MA) said a letter to EPA this month to urge the agency to meet its deadline. "Despite worldwide agreement about the toxicity of these chemicals and their persistence in the environment, EPA has yet to release its findings on how dangerous these chemicals are to public health."
According to CDC, dioxins and polychlorinated biphenyls (PCBs) have a similar toxicity.
"Human health effects from low environmental exposures are unclear," says CDC on its resource page. "People who have been unintentionally exposed to large amounts of these chemicals have developed a skin condition called chloracne, liver problems, and elevated blood lipids (fats). Laboratory animal studies have shown various effects, including cancer and reproductive problems."
For more information on dioxin exposure, see
FDA's resource guide here.
Medtronic and Boston Scientific throw their support behind the tentative agreement, which more than doubles the FDA's medical device review user fees over the next 5 years, but Cook Medical isn't convinced that the agency can keep its promises.
Medical device makers and industry lobbyists lined up in support of the tentative agreement inked with the FDA to double user fees in exchange for performance goals, but some voices in the crowd said 'nay.'
Writing in the
Morbidity and Mortality Weekly Report, the CDC said it is working with the Pennsylvania State Health Department to investigate an 18-state outbreak of illnesses associated with handling small turtles.
From Aug. 5, 2010 to Sept. 26, 2011, 132 cases of infection from Salmonella Paratyphi B var. L (+) tartrate + were reported, according to the CDC. (If that serotype doesn't sound very scary, consider what the infection is called -- paratyphoid fever)
Many of those stricken were kids, who don't pay much mind to safe-turtle handling practices. Median age of the outbreak cases was 6 years old.
"Although many reptiles carry Salmonella, small turtles pose a greater risk to young children because they are perceived as safe pets, are small enough to be placed in the mouth, and can be handled as toys," the CDC wrote.
Health authorities keep reminding people that
pets can be pathogen carriers, and emphasize the importance of hand washing after touching them. Last year, the CDC reported at least 214 people sickened by their Salmonella-laden
African dwarf frogs, and at least 71 individuals (more than half of them younger than 5) infected with Salmonella from
backyard chicks and ducklings.
Salmonella can make people sick with diarrhea, vomiting, fever and severe abdominal cramps. Young children are especially at risk for illness because their immune systems are still developing.
In the epidemiologic investigation of this latest turtle outbreak, 56 ill individuals were interviewed to determine their possible exposure to Salmonella, and 36 (64 percent) of them reported handling turtles. Fourteen people identified turtles too small to be legally traded, according to the CDC.
Five samples of turtle tank water collected from patients' homes tested positive for the outbreak Salmonella strain.
The sale of turtles with shells smaller than 4 inches has been
banned by the Food and Drug Administration since 1975, after thousands of infants and small children were diagnosed with turtle-associated salmonellosis. Before the ban, epidemiologic studies indicated that 14 percent of reported salmonellosis in the United States was attributable to pet turtles.
Despite the ban, transient vendors on the street, at flea markets and at fairs continue to peddle the turtles as pets, the report notes.
The CDC observed that in 2007, the Independent Turtle Farmers of Louisiana
sought to overturn the prohibition on the sale of tiny turtles, but a federal district court upheld the FDA's authority to enforce the ban.
Given this latest outbreak, the CDC says the ban is being ignored, and
efforts to educate the public about the risks of small turtles aren't working. It suggests examining those efforts.
AdvaMed's Ubl calls MDUFMA III a "game-changer," AngioDynamics' CEO says the Navilyst deal hits the reset button and a clutch of former reps of a Symmetry Medical subsidiary consent to judgement in a lawsuit accusing them of cooking the books.
Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This feature of MassDevice.com's coverage highlights our 3 biggest and most influential stories from the day's news to make sure you're up to date on the headlines that continue to shape the medical device industry.
If you read nothing else today, make sure you're still in the know with MassDevice +3.
News Well,
510(k) reforms,
Food & Drug Administration (FDA),
MDUFMA,
Mergers & Acquisitions,
Plus 3,
Wall Street Beat
Source: HealthDay
Related MedlinePlus Pages:
Cystic Fibrosis,
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