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USDA setting pathogen baselines for cattle, hogs, poultry
By Rita Jane Gabbett on 3/19/2010
USDA is testing cattle, hog, chicken and turkey carcasses to reset existing pathogen testing baselines and plans to create baselines for beef trim, other beef components, bench trim, ground beef and chicken parts, according to a USDA official.
The baselines are used to determine the process control capability of the industry, Deputy Assistant Administrator for USDA's Food Safety and Inspection Service Daniel Engeljohn told participants at a one-day seminar in Chicago on E. coli O157:H7 prevention presented by the North American Meat Processors Association.
To create the beef baselines, USDA will take one sample immediately post-hide removal but prior to decontamination interventions and evisceration. A second sample will be taken post-chill after all decontamination interventions but prior to fabrication. The tests will baseline pathogen reductions achieved by current industry practices.
When USDA first issued HACCP regulations in the mid-1990s the agency created baselines for nine classes of pork, poultry and beef carcasses and used that baseline data to establish pathogen performance standards.
Engeljohn told Meatingplace that for hog and poultry carcasses, these new tests will reset the performance standards. For cattle, earlier tests were only performed post-chill, so adding the pre-decontamination test will provide new data upon which to base performance standards. For trim, other beef components, bench trim, ground beef and chicken parts, the tests will create new performance standards.
Engeljohn said it takes about a year to complete the baseline testing. USDA has already started on hogs and plans to start on cattle at the beginning of 2011.

Salmonella incidence rises, focuses FSIS¡¯ attention (UPDATED)
By Tom Johnston on 3/19/2010
CHICAGO Of the estimated 286,040 cases of human illness associated with meat, poultry and egg products inspected by USDA's Food Safety and Inspection Service in 2009, 272,522 were caused by salmonellosis. By comparison, there were 12,240 cases of E. coli O157:H7 and only 1,178 cases of listeriosis.
Dan Engeljohn, deputy administrator of FSIS's Office of Policy and Program Development, told attendees here today at the North American Meat Processors Association 2010 Meat Industry Management Conference that efforts since 1997 to cut in half illnesses associated with these major foodborne pathogens have resulted in drastic reductions in E. coli and listeriosis, but salmonellosis is on the rise.
"It's not that we're tolerating this number of illnesses; this is obviously a number for which we do intend to put in place mitigations to reduce the number of human illnesses. ¡¦ Our charge is to reduce the number of illnesses associated with FSIS products at least by 1 percent each year between now and the year 2015. So there will be some aggressive actions."
Most immediately, Engeljohn said the agency is committed to establishing by the end of 2010 new pathogen reduction standards for salmonella in broiler and turkey carcasses. The same goes for campylobacter.
Engeljohn said the goal is to ensure that at least 90 percent of the industry passes the new salmonella standards for broilers and turkey carcasses by end of December 2010.
"So we have roughly nine months to start implementing a program in which we will specifically be driving down exposure of the public to salmonella in turkey and broiler carcasses," he said.
FSIS also has expanded comminuted poultry product subject to salmonella performance standards to include mechanically deboned product. The goal, Engeljohn said, is to reduce the chances that consumers will get sick even when they mishandle or improperly prepare such product. The agency will begin sampling for salmonella in mechanically deboned product.
Meanwhile, FSIS is considering deeming salmonella an adulterant in not-ready to eat stuffed poultry products that appear to be ready to eat, he said.
This article was updated to include part of the story that was inadvertently left off of the original published item.

USDA to take stronger action on recalls at slaughter plants
By Rita Jane Gabbett on 3/19/2010

USDA is getting more aggressive in its reaction to pathogen contamination and may be recalling more products earlier in the game when a presumptive positive for E. coli O157:H7 at a further processing facility is traced back to a particular slaughter facility, according to Deputy Assistant Administrator for USDA's Food Safety and Inspection Service Daniel Engeljohn.
Engeljohn told participants at a one-day seminar in Chicago on E. coli O157:H7 prevention presented by the North American Meat Processors Association that USDA is changing its earlier practices, which did not focus on recalling additional products made by a slaughter facility implicated in a single recall.
Going forward, he said when a presumptive positive for E. coli O157:H7 is found at a grinding establishment, once supplier data is gathered, Enforcement Investigations and Analysis Officers (EIAOs) will immediately begin assessing the available agency data on the supplier.
EIAOs will then conduct a plant assessment, using new methodology to determine whether the affected production lot and other lots produced using the same source material, same conveyor belts and same equipment contact are no longer considered microbiologically independent.
If they determine microbiological independence is no longer valid and insanitary conditions are now evident, affected products will be subject to voluntary recall and so might associated source material, such as primals and sub-primals as appropriate.
Engeljohn said USDA plans to publish details of its new traceback methodology quickly so the new procedures will be in place for the April through September months when pathogen positives often increase with the warmer weather.

USDA to mandate test and hold, non-intact meat labels

By Rita Jane Gabbett on 3/19/2010
USDA plans to propose rules that would mandate test-and-hold practices at meat plants as well as labels alerting consumers when they are buying non-intact meat subjected to mechanical tenderization, according to Deputy Assistant Administrator for USDA's Food Safety and Inspection Service Daniel Engeljohn.
Engeljohn told participants at a one-day seminar in Chicago on E. coli O157:H7 prevention presented by the North American Meat Processors Association they can expect to see Federal Register policy documents on those two issues, as well as on new mandatory record keeping requirements that would facilitate traceback at retail when a product is recalled.
Traceback records
"We are often stymied in our traceback investigation efforts at retail. We can't get beyond retail because the records are too poor," said Engeljohn. The proposed rule would require processors to keep specific types of documents relative to what source materials are used and when they are used to produce products to facilitate a product traceback.
He said the rules would apply to all food products a processor produces, but noted ground beef is where the biggest traceback problems have occurred.
Test and hold
"The industry collectively petitioned the agency to put in place a mandatory test and hold and we think that would be prudent for public health protection," said Engeljohn. He said USDA would be issuing a Federal Regsiter notice on this policy change.
"This is not just specific to ground beef, this would be for any time the agency or the establishment is collecting a verification sample for an adulterant. The policy will be that you must get that test result back before you release that product into commerce," Engeljohn said, noting the policy would still allow product to be moved to another facility owned by the establishment, as long as the establishment maintains control of the product.
Non-intact meat labels
"(USDA) is announcing that it is going to pursue mandatory labeling for non-intact beef products that have been mechanically tenderized; whether it is by blade tenderization or needle injection," said Engeljohn. "We are intending to pursue a regulation that would mandate that product be labeled and that label carried through the processing of that product until it is made into a red meat product."
USDA has been under increasing pressure to label non-intact meat since the December recall of mechanically tenderized steaks by National Steak and Poultry. The American Meat Institute has countered that no special labeling is needed, noting that all steaks in retail stores, whether blade-tenderized or not, must bear safe handling labels instructing consumers how to cook and handle them to ensure they are safe when served.
Current safe handling instructions, however, don't give specific temperatures and don't include specific instructions on how to safely prepare a steak, according to Engeljohn.
"It is the agency's belief there is increased risk associated with mechanical tenderization over and above an intact steak in terms of preparing it. A non-intact product should be prepared differently," he said. "That's not to say you can't prepare a rare or medium steak that's non-intact. The issue is cooking it at the right temperature for the right amount of time."

One failed test sinks family business
Chicago meat grinder Prange Meats says it isn't the source of deadly E. coli found in a sample from its plant but it can't afford the risk of another positive test.

By Steve Mills March 20, 2010
Chicago - Dan Kotara's 35 years of grinding meat into hamburger ended last year after a single positive test for a potentially deadly strain of E. coli. Unable to market thousands of pounds of meat, he rented a trash bin and doused the food in black ink to render it unusable.
His loss: an estimated $25,000.
After that August test, Kotara decided he could no longer risk another costly positive result. He laid off his eight employees and sold the grinders, massive freezers and other equipment from his low-slung building in Chicago. He is selling his building, too, so it can be razed for a parking lot.
What rankles Kotara is that federal meat-safety inspectors never identified the source of the contamination or connected it to a deficiency at his small plant. He could do everything right at Prange Meats Inc., his family business, yet still lose money because of shoddy practices by one of his suppliers, he concluded.
"Is this the right way to do things? No, I don't think so," Kotara said as he walked through his empty plant. "The right way to do things is to address the problem at the root, and that's on the kill floor."
The closing of Prange Meats is emblematic of a persistent problem with meat safety that the Chicago Tribune examined last month: The U.S. Department of Agriculture does not try to identify the source of contamination after a routine test comes up positive.
The case shows how one incident can result in the closing of a business built up over decades, no matter how committed it is to safety and sanitation. By all accounts, Kotara had a good record, without a single positive test for E. coli before last year.
Kotara said he could have absorbed the financial loss, but the chance of another test coming back positive was more uncertainty than he could take.
"I'm making hamburger patties," Kotara said. "Really, who needs all of this aggravation?"
Kotara said as much in a note to Jay Wenther, executive director of the American Assn. of Meat Processors, an industry group composed mostly of smaller, independent grinders and processors. Kotara had been a member for 15 years.
Processors of all sizes are growing frustrated with the challenges and risks of the business, Wenther said in an interview. Eliminating E. coli is impossible, he said, unless changes are made at the slaughterhouses, and even then it's hard to achieve. One measure that might help, Wenther said, would be irradiating whole carcasses to kill pathogens.
"While we're doing as much as we can, the general public wants 100% safe food," he said. "But that's not very realistic."
In mid-August, a USDA inspector took a 1-pound sample of ground beef from a machine that makes hamburger patties, boxed it up and sent it to a lab in St. Louis to be tested for salmonella andE. coli 0157:H7, the dangerous strain of E. coli that can cause kidney failure and other serious ailments.
Kotara had received the meat and the trim, totaling more than 13,000 pounds, from two of his suppliers, one in Australia and the other in Chicago. The Chicago firm, City Foods Inc., in turn was supplied by a company in Omaha, said a spokeswoman for the USDA's Food Safety and Inspection Service.
Tests for E. coli done at the suppliers' facilities were negative, Kotara said.
Kotara said his plant typically was tested by federal inspectors about once a month, though sometimes more frequently during warmer months.
Because inspectors take for testing only a small portion from what often is a huge amount of meat, contaminated products can pass through a distribution chain yet still test negative for the presence of E. coli, food safety experts said.
The meat also had been subject to at least one intervention step, a measure aimed at eliminating or controlling E. coli., such as treating meat with steam sprays and anti-microbial washes.
Still, somehow, the sample was tainted. Kotara never learned how or where it was contaminated but insists it was not at his plant. Several follow-up tests for E. coli, Kotara said, all were negative.
"Same machines. Same employees. Same processes," he said. "And the tests were negative."
A USDA spokeswoman said Prange's record showed "no trends that demonstrate inadequate food-safety systems" and no evidence of noncompliance since 2005.
Experts agreed it was unlikely, though not impossible, that a grinder would be the source of E. coli contamination. The more likely culprit, the spokeswoman said, is the slaughterhouse.
Mills writes for the Chicago Tribune.

FDA roasted over irradiation petition handling
By Rory Harrington, 22-Mar-2010
A US Congressional watchdog has slammed the Food and Drug Administration (FDA) for a catalogue of failings over its handling of petitions to use irradiation on food.
The Government Accountability Office (GAO) said the food regulatory agency was too slow in reviewing six outstanding irradiation applications, and had failed to meet statutory and regulatory deadlines in which to deliver a verdict.
FDA officials had also consistently not documented its decisions about the petitions and failed to communicate key information to applicants, said the GAO.
¡°As a result, FDA¡¯s petition review process lacks transparency and leads to understanding and confusion among petitioners,¡± added the body in a stinging report.
Food irradiation is the process of exposing food to ionizing radiation in order to control foodborne pathogens. Food is irradiated using gamma rays, X-rays or electron beams. Its use is permitted in 56 countries and the process has been declared safe by the World Health Organisation, the US Department of Agriculture and the Food and Drug Administration (FDA). The GAO cited research that said the technology had the capacity to eliminate 99.999 per cent of potentially deadly bacteria such as E.coli, Listeria monocytogenes and Campylobacter.
DA failures
The report listed how the FDA repeatedly failed to acknowledge receipt of petitions within the prescribed 15-day deadline or notify applicants of their success or failure. The six petitions have been under deliberation for an average of 8.5 years and some for as long as a decade.
The paper noted that FDA employees said the 180-day timeframe to decide on a petition was too short - but added that the agency had never requested a change in the law. The FDA is not obliged to make any reports on an application once the deadline has passed, said the report. The food safety watchdog was also criticised for its lack of documentation on the outstanding petitions.
¡°FDA¡¯s petition files contain little or no documentation of its decision-making on the six petitions and in some cases fail to reveal the process FDA used to make decisions¡±, said the report.
Giving an example of the FDA¡¯s working practices, the GAO outlined how two petitions for irradiating meat and poultry were held up for almost ten years because the agency had decided to review them in conjunction with a third application for multi-food ingredients to save cost and time ? although no record of this decision existed in any file.
The delay appeared to stem from concerns that furan, a carcinogenic colourless liquid, can form during irradiation. However, even though the agency determined in 2003 that furan was not an issue with irradiated meats, those petitions remain blocked in the system because they are still administratively ¡°linked¡± to the multi-ingredient petition over which FDA concerns persist.
The FDA admitted its mistake in this respect and acknowledged it was possible to move forward with the meat and poultry applications. However, the agency said it had yet to set a deadline to finish it review of those meat applications.
The safety body has also failed to communicate properly with applicants which has limited their ability to understand or respond to FDA actions and decisions, said the oversight office.
The GAO urged the FDA to overhaul its administrative processes by documenting key decisions and communicating more effectively. The agency said it accepted the recommendations and had begun to implement them.

Is raw, unpasteurized milk safe?
There's long been a libertarian streak running through the raw-milk crowd. A Christian one, too. Now it's attracting another demographic entirely: advocates of local food. Dairymen are seizing that opportunity. Five years ago, there were six licensed raw-milk dairies in Washington; today there are 28.
By Maureen O'Hagan Seattle Times staff reporter
Unpasteurized milk is a curious thing. It costs up to $13 a gallon. It says right on the carton: "WARNING: This product ... may contain harmful bacteria."

Yet people are passionate about it. Almost evangelistic.
So in early December, when the state announced that raw milk from Dungeness Valley Creamery in Sequim was linked with three E. coli cases, the reaction was, well ... emotional.
"Lies," more than one raw-milk drinker posted on the Dungeness dairy's Web site, in response to the state's announcement.
"Trickery," another supporter wrote.
"Despicable," wrote a third.
Never mind that health authorities like the Centers for Disease Control (CDC) and the Mayo Clinic say you shouldn't drink the stuff. To some, the bad news is evidence of a conspiracy. It involves Big Ag trying to stamp out the little guy, Big Government pushing its way into our kitchens, sleazy lawyers trying to make a buck, and scientists who malign a key to good health.
Now, Whole Foods Markets has become a target. The company recently halted raw-milk sales nationwide, saying it needed a "rigorous companywide standard." It was another sign, one pro-raw-milk blogger wrote, of the "ever more sinister campaign against food rights." There are calls for a boycott of the company.
Raw milk's supporters are at once modern-day rebels and throwbacks to an older, simpler time. They are health-food aficionados who dismiss the health authorities.
There's long been a libertarian streak running through the raw-milk crowd. A Christian one, too. Now it's attracting another demographic entirely: advocates of local food.
"It is an emblem of noncorporate food," best-selling author Michael Pollan, godfather of the local-food movement, wrote in an e-mail to The Seattle Times.
Dairymen are seizing that opportunity. Five years ago, there were six licensed raw-milk dairies in Washington; today there are 28.
And though Pollan thinks people should be able to eat what they want, he notes there is a disconnect.
"I think people turn a blind eye to some of the food safety concerns," he wrote.
Indeed, along with the growth in raw milk's popularity has come a rise in dairy-related food-borne-illness outbreaks, according to the Center for Science in the Public Interest, a consumer research, advocacy and education organization.
Which brings us back to the Dungeness creamery and its owner, Jeff Brown. During a long morning spent milking, soothing and coaxing cows, Brown blasted the government overseers whose actions temporarily disrupted his business. He spoke about freedom. And he said the truth is simple:
"Everything God designed is good for you."
"Value-added" niche
People don't get into the dairy business because of the hours, or the glamour.
"My claim to fame is: I'm the world's slowest milker," Brown announced proudly. A sturdy man of 58, he loves to talk.
He remembers when he was 14, "praying the dairy industry would stay good so I could milk cows."
He started his own farm in 1971 and began contracting with Darigold, which pasteurized and distributed his milk. But Brown, like dairymen all over the country, worried about declining wholesale prices.
"In order to make it, you have to milk a lot of cows and your cow numbers have to constantly be getting bigger," Brown explained. Otherwise, "your profit margin will continue to shrink."
In order to stick with about 60 cows, Brown saw just one option: sell a "value-added" product.
For years, people had asked Brown if he'd sell his milk straight from the cow, unpasteurized. The heating process kills most disease-producing organisms, but it also changes the taste.
With the surge of interest in local food, Brown and his family saw opportunity. They got their raw-milk license in 2006.
"Five years earlier, I don't think the market was there," he said.
Today, the Dungeness creamery is one of the larger raw-milk producers, bottling more than 200 gallons a day.
It used to be, you'd have to go directly to the farm or a cooperative "drop site" to buy raw milk. Now it's increasingly in grocery stores ? and it flies out the door.
Warning labels don't hurt sales, Brown said. They're "a badge of honor."
True believers
People who like raw milk really like raw milk.
They say it fights everything from allergies to asthma, digestive problems to learning disabilities. It eases arthritis pain and improves cholesterol, boosts immunity and clears cataracts.
When you pasteurize milk, they say, it kills key nutrients and leads to things like heart disease.
The FDA says none of this is scientifically proven. After finding "raw milk, no matter how carefully produced, may be unsafe," the agency banned its interstate sale in 1987.
Washington is one of seven states that allows its retail sale. Most states permit limited sales, such as on the farm. It's illegal in 10 states.
In states with limited availability, people drive hundreds of miles to get their raw-milk fix. They break laws and stage protests. They have long maintained they're being picked on.
"Never in the annals of health and nutrition has there been a food so maligned, lied about and conspired against as raw milk," a national group pushing universal access posted on its Web sites.
When Dungeness customers learned The Seattle Times was working on this story, they flooded the paper with eager calls and e-mails.
Mary Solberg, of Sequim, was one of them. She was drawn to raw milk's flavor, but she heard there could be risks, so she did some reading and visited Dungeness. After that, she was satisfied.
"They're here in the community," she said. "I just felt safe."
Illnesses on the rise
Public-health authorities say raw milk is risky, local or not. They cite two main reasons. The first is, it's consumed uncooked. The second has to do with the guts of cows.
All cows ? actually, all warm-blooded animals ? have E. coli in their guts. Some strains of it are harmless. Others are not. They're called Shiga toxin-producing E. coli, and "cows are the main source where these organisms live," said J. Kathryn MacDonald, a state epidemiologist.
The Shiga toxin doesn't hurt the cows, but it can make humans very, very sick ? as in kidney failure, coma, stroke, prolonged hospitalization. Even death.
We get E. coli illness by swallowing the bug.
Actually, by swallowing tiny bits of manure containing the bacteria. "This happens more often than we would like to think," the CDC said on its Web site.
Experts say hamburger is a big culprit. The good news is, heat kills E. coli and other pathogens. That's why food-safety experts say to cook hamburger thoroughly. It's called a "kill step."
For milk, pasteurization is the kill step. Without it, there's nothing between you and any bugs that might be swimming around. The chance there's a deadly pathogen in a particular glass of milk may be small, but it's a risk no one has to take.
James E. McWilliams, author of a book questioning the locavore movement, puts it bluntly:
"To me, it's Russian roulette," he wrote in an e-mail. "The whole of human history is about humans being taken down by diseases transferred from animals to people. Pasteurization was perhaps the most significant advance ever made in reducing the transmission."
Indeed, despite cleanliness rules and inspections, pathogens still get in. Every year since 2005, the Washington State Department of Agriculture (WSDA) has identified food-borne pathogens in retail raw milk.
Just last month, the WSDA found E. coli in raw milk from Jackie's Jersey Milk, a Bellingham company. It was linked with several cases of illness, according to state officials.
The agency has never found pathogens in its tests of pasteurized milk, nor has it linked cases of human illness to pasteurized milk.
In all, between 2005 and 2009, 395 Washingtonians with lab-confirmed cases of food-borne pathogens reported consuming raw-milk products shortly before getting sick, the state Department of Health says.
Nationally, food-borne-illness outbreaks associated with dairy have "increased dramatically" since 2004, "in large part due to a rise in outbreaks from unpasteurized dairy products," according to Center for Science in the Public Interest. Raw milk is one of a few products for which the nonprofit says "Do Not Eat."
Using data from the CDC, the group found that raw milk accounts for 80 percent of milk-related food-borne-illness outbreaks nationally, yet it's only a fraction of total milk sales. The CDC said there have been at least two deaths nationally connected with raw milk between 1993 and 2006.
Proponents like to point out there are E. coli outbreaks associated with vegetables and fruits, too. So why focus on milk? It's because E. coli isn't inherent to vegetables like it is to cows. The bug has to be introduced somehow, like through irrigation water. The key point: When you hear about food-borne illness, think manure.
Trying to keep clean
Cows create a lot of waste. They do it in the barn and in the fields. They do it while they're being milked. It's liquid and it splatters. It's on their legs and tails and udders. Preventing waste from getting in the milk is all-important.
Every morning and every evening, Brown ushers his herd into the milking parlor, eight at a time. He dips each cow's teats in an iodine solution, which helps reduce, but not eliminate, bacteria. Then he wipes them with a cloth. He gets a fresh cloth after four cows.
It's easy to see potential problems. He doesn't exactly study the udders to make sure he's cleaned every last inch. And it's messy. On a recent visit, one cow, who was sore, fussed as Brown started the milking device. She pooped, splattering Brown's face, but he didn't seem to notice. She fussed so much that the device fell to the floor, and the cow stepped on it. When Brown finally got her off it, he sprayed it with a hose. Then he put it on the next cow.
"When they get upset, this is the result," he said later, wiping his face and arms. Then he was ready for the next group of eight.
Danger sign?
Last spring, problems arose at Dungeness, according to state records. Each month, the state tests milk for certain indicators, like coliform bacteria, that may suggest issues with cleanliness or animal health. In May, one indicator at Dungeness was 10 times the legal limit. In June, another indicator was 15 times the legal limit. The farm exceeded counts in July, September, November, December and January, too.
The amounts weren't enough to be harmful to humans, but the state sees high counts as signs of trouble and it requires producers to bring them down.
Asked repeatedly about the numbers, Brown kept changing the subject.
"If they really thought there was a problem," he said of the state agriculture department, "they would say: don't sell the milk. They ... never did that."
Tracing a pathogen
In September, a Snohomish girl tested positive for E. coli illness. In November, a Redmond boy briefly was hospitalized with it. That month, a Vancouver, Wash., man was diagnosed and said he missed work for nearly three weeks. All have recovered.
Authorities swooped in with questionnaires for the patients and later found a single link among the three: Dungeness milk.
According to MacDonald, the epidemiologist, the bugs that infected the Redmond boy and the Vancouver man "had the exact same DNA fingerprint." Investigators concluded, then, they "had a common source."
The Snohomish girl was infected with a different strain of the pathogen, and inspectors found that same strain on the farm ? a genetic match with the one that made her sick.
Investigators concluded there was just one way that particular bug could have gotten from the farm to the girl. "It was the milk she drank," MacDonald said.
But here's where Brown and the dairy's supporters get up in arms. Inspectors never found E. coli in the milk. It was in manure.
To the Brown family, this was proof of "government bias against raw milk."
Not so, said MacDonald.
"It puts that particular strain of E. coli on that farm," she said. "And somehow or another, it got in the milk ? which is not hard to imagine, if you think about where the manure comes from and where the milk comes from. It's not a very far distance."
Milk not recalled
There was no recall of Dungeness milk. Recalls are intended to remove contaminated product from store shelves, and in this case, the pathogen wasn't found in the milk. Some stores, including Whole Foods, stopped selling Dungeness milk briefly. It was back on the shelves until earlier this month, when the retailer stopped selling raw milk nationwide. A spokeswoman declined to elaborate.
Brown thinks he will make up for the lost sales. Even after his dairy was connected with the three E. coli cases, many customers remained loyal. Some made a point to go out and buy more.
Mary Solberg's husband, for instance, proceeded to immediately "open and drink our new half gallon."
Better to trust the small farmer than some faceless corporation, she said.
Brown maintains the government has unfairly damaged his farm's reputation.
"You know how you can tell they're lying?" he said. "Their lips are moving."
A dairy changes course
Tim Lukens used to feel a lot like Brown. In 2006, the state descended on his Grace Harbor Farms, near Bellingham, after two children were diagnosed with E. coli illness. Initially, Lukens said, he "didn't want to believe" his milk was responsible.
He has since learned a lot. First of all, cows shed the E. coli bacteria intermittently. The milk could be fine one day, contaminated the next.
Besides, he said, "You cannot clean a cow's udder off well enough every time" in a commercial operation.
In addition, scooping up milk samples for testing is like fishing. Just because the WSDA doesn't catch anything doesn't mean there aren't any fish in the lake.
"What happens if there was E. coli floating in there and you didn't happen to get it?" he said. "All it takes is one bottle with a few cells."
And lastly, there is the problem of temperature. Bacteria grows in temperatures over 40 degrees. Dairymen quickly cool their milk, but there's no guaranteeing what happens when it gets to the consumer.
"What starts as one or two cells could grow into hundreds," Lukens said.
He stopped selling raw milk after he learned all this.
"My opinion is, there's no possible way you can keep fecal contamination out of a milk stream," he said. "We came very close to one of the worst things somebody can experience ? causing some kind of permanent malady in someone else's life."
Some people say Lukens has it all wrong. "Some of them are still convinced I got framed," he said. "I didn't."
Brown, however, remains steadfast.
"God designed raw milk; man messed with it," he said. "You draw your own conclusions."

An argument for pasteurization

Safety Zone
By: James Marsden

At the recent meeting of the Beef Industry Food Safety Council (BIFSCo), Dr. David Smith, a professor of Veterinary Medicine at the University of Nebraska presented a history of the events that led to the 1924 Standard Milk Ordinance and the systematic pasteurization of raw milk. There many analogies to the public health issues associated with raw milk and the problem of E. coli O157:H7 in beef that we face today.
The major public health problem associated with raw milk that led to the Standard Milk Ordinance was Tuberculosis (TB). Tuberculosis was a major problem in the US in the 19th and early 20th centuries. It is still one of the top three infectious diseases in the world along with AIDS/HIV and malaria. It affects one third of the world's population and is responsible for over 2 million deaths every year. Most of today's problems with tuberculosis are in developing countries.
After it was discovered that people could be infected with TB from raw milk, the federal government initiated a testing program to eradicate the problem in cattle and in 1924, passed the Standard Milk Ordinance. The programs to control TB were successful.
The solution to the TB problem in cattle involved pre-harvest interventions, testing and the systematic pasteurization of raw milk. The solution to the problem of E. coli O157:H7 in beef will involve the same basic components.
The issue of consumer responsibility and proper cooking seems to continually dominate this blog. Of course, ground beef needs to be properly cooked in order to eliminate E. coli O157:H7. I suppose that if consumers cooked raw milk, it could also be made safe to drink. However, the real solution in beef, as it was in raw milk, has to be to eliminate the problem of E. coli O157:H7 before it ever reaches the consumer.
I submit that a combination of effective pre-harvest interventions, combined with validated antimicrobial technologies applied at slaughter and carcass pasteurization and microbiological testing (for process verification) would lay the foundation for E. coli O157:H7 free beef products.
There would still be a need for excellent sanitation, prevention of contamination from environmental sources and processing interventions. The pasteurization of packaged consumer products using irradiation or high hydrostatic pressure may also eventually play a role in the overall process. In order for this approach to be successful, it would have to be universally applied, in the same manner as the systematic pasteurization of milk was required almost 100 years ago.
I am sure that in the early 1900's, the problem of TB in raw milk seemed insolvable. Yet it was solved. The objective of producing pathogen free raw ground beef products will also be difficult to say the least. The beef industry really has no choice but to succeed.

March 22, 2010

Victims of Contaminated Meat Call on USDA to Address Pathogens
S.T.O.P. - Safe Tables Our Priority and victims of foodborne illness called upon the United States Department of Agriculture to recognize as adulterants six other potentially deadly types of E. coli bacteria in addition to the notorious E. coli O157:H7 that is currently classified as an adulterant. All seven strains are known to cause devastating human illness and are transmitted through feces-contaminated beef products.
"The USDA and the Centers for Disease Control and Prevention (CDC) have known for decades of the public health risks posed by non-O157 strains of E. coli," said S.T.O.P. President Nancy Donley, whose son died from E. coli O157 in 1993. "Yet, 10 years after requiring public health laboratories to report positive test results for these strains from infected people, nothing has been done to prevent meat contaminated with these strains from entering into commerce."
E. coli O157:H7 was declared an adulterant in ground beef in 1994 in the aftermath of an outbreak that sickened more than 700 people and killed at least four. The CDC has since identified six additional strains of shiga-toxin producing E. coli (STEC) -- O26, O111, O103, O121, O45 and O145 -- associated with severe illness and death. Just like E. coli O157:H7, these STEC strains get into the nation's beef supply when cattle feces contaminate meat during slaughter and processing.
At a demonstration outside USDA, Donley and other victim members of S.T.O.P. demanded that USDA enact health-based strategies to prevent all types of E. coli-contaminated beef from reaching consumers' tables.
According to the CDC, 76 million Americans become sick from foodborne pathogens each year and 325,000 are hospitalized, of which 5,000 die.

Chinese consumed millions of gallons of toxic sewage oil: study
By Stephen C. Webster
Monday, March 22nd, 2010 -- 10:05 pm
Chinese cooking oil siphoned from restaurants' waste tanks and stripped out of raw sewage is being resold on the cheap and has for years tainted approximately one out of every ten meals cooked in the eastern nation, according to a recent study.
The revelation, first noted by state media, sent Chinese health inspectors into a snit as they scrambled to reassure the public that the claims were being investigated.
"He Dongping, a professor at the Wuhan Polytechnic University, has been studying the problem for seven years," newspaper Epoch Times noted. "According to China Youth Daily, he found that China recycles an estimated two million to three million tons of waste oil per year. Combining that figure with the estimated 22.5 million tons of total vegetable oil and animal fat consumed by the Chinese per year, it is estimated that 10 percent is returning to people¡¯s dining tables."
The only apparent difference between the toxic sewage oil and normal oil is the remarkable price difference, with the tainted cooking stock selling for approximately half the price of its legitimate competitor.
"In addition to an effective method of detection having yet to be found, the difficulty is compounded once the illegal oil has been blended into ordinary ones," state media China Daily reported. The 'illegal cooking oil' is usually made from discarded kitchen waste that has been refined [after being sieved out of raw sewage]. Although it looks clean and clear, it actually contains toxic substances, including 'aflatoxin', which can cause cancer."
"Aflatoxins are toxic metabolites produced by certain fungi in/on foods and feeds," according to Cornell University. "They are probably the best known and most intensively researched mycotoxins in the world. Aflatoxins have been associated with various diseases, such as aflatoxicosis, in livestock, domestic animals and humans throughout the world. The occurence of aflatoxins is influenced by certain environmental factors; hence the extent of contamination will vary with geographic location, agricultural and agronomic practices, and the susceptibility of commodities to fungal invasion during preharvest, storage, and/or processing periods."
The state-run China Daily news agency encourages consumers to be suspicious, recommending that buyers "taste" the cancer-causing substance before making a purchase.
The International Agency for Research on Cancer has identified aflatoxin B1 has a confirmed carcinogen in humans.
China's State Food and Drug Administration has vowed to close down any eatery found using tainted cooking oil.
This most recent food safety scandal comes on the heels of a devastating episode in which hundreds of thousands of Chinese infants were poisoned in 2008 by the chemical melamine, which had been used as a spacing ingredient in baby formula.
China consumes over 22 million tons of cooking oil each year, according to the study.

Report: States struggle to tally foodborne illnesses
By Elizabeth Weise, USA TODAY

State and local reporting of foodborne illnesses is the first line of defense against national outbreaks. Yet a study by the Center for Science in the Public Interest finds that almost half of states do a poor job of tracking outbreaks ? and suggests passing legislation to reform the Food and Drug Administration will help.
A vital piece of the nation's food safety system is broken, says Caroline Smith DeWaal, the center's food safety director. She will present her findings at a U.S. Department of Agriculture-sponsored Food Safety Education Conference in Atlanta today.
Twenty-three states reported no more than three foodborne illnesses per million residents in 2007. Of those, 12 reported just one. That's compared with nine states with strong public health surveillance that reported 10 or more per million the same year. The data come from the Centers for Disease Control and Prevention.
Tracking the number of reported illnesses is a good measure of a state's investment in public health surveillance, says Craig Hedberg, a professor of epidemiology at the University of Minnesota.
It helped pick up recent outbreaks linked to spinach, peanut butter and hot peppers and is "key to figuring out the causes of big, multistate outbreaks," he says.
Smith DeWaal says, "Outbreaks are what identify contaminated food products in the market so that they can be removed or recalled before they make other people sick."
The Food Safety Modernization Act, scheduled to go before the Senate in April, would require FDA to coordinate federal, state and local surveillance systems, Smith DeWaal says.
"More than 350,000 Americans are hospitalized each year and 5,000 die from preventable foodborne illness," says Sen. Richard Durbin, D-Ill., who wrote the act. "We need to strengthen the state-federal partnership as we work to strengthen the nation's food safety laws."

Amid Nanotech's Dazzling Promise, Health Risks Grow
Andrew Schneider Senior Public Health CorrespondentAOL News

First in a Three-Part Series
(March 24) -- For almost two years, molecular biologist Benedicte Trouiller doused the drinking water of scores of lab mice with nano-titanium dioxide, the most common nanomaterial used in consumer products today.
She knew that earlier studies conducted in test tubes and petri dishes had shown the same particle could cause disease. But her tests at a lab at UCLA's School of Public Health were in vivo -- conducted in living organisms -- and thus regarded by some scientists as more relevant in assessing potential human harm.
Halfway through, Trouiller became alarmed: Consuming the nano-titanium dioxide was damaging or destroying the animals' DNA and chromosomes. The biological havoc continued as she repeated the studies again and again. It was a significant finding: The degrees of DNA damage and genetic instability that the 32-year-old investigator documented can be "linked to all the big killers of man, namely cancer, heart disease, neurological disease and aging," says Professor Robert Schiestl, a genetic toxicologist who ran the lab at UCLA's School of Public Health where Trouiller did her research.
UCLA molecular biologist Benedicte Trouiller found that nano-titanium dioxide -- the nanomaterial most commonly used in consumer products today -- can damage or destroy DNA and chromosomes at degrees that can be linked to "all the big killers of man," a colleague says.
Nano-titanium dioxide is so pervasive that the Environmental Working Group says it has calculated that close to 10,000 over-the-counter products use it in one form or another. Other public health specialists put the number even higher. It's "in everything from medicine capsules and nutritional supplements, to food icing and additives, to skin creams, oils and toothpaste," Schiestl says. He adds that at least 2 million pounds of nanosized titanium dioxide are produced and used in the U.S. each year.
What's more, the particles Trouiller gave the mice to drink are just one of an endless number of engineered, atom-size structures that have been or can be made. And a number of those nanomaterials have also been shown in published, peer-reviewed studies (more than 170 from the National Institute for Occupational Safety and Health alone) to potentially cause harm as well. Researchers have found, for instance, that carbon nanotubes -- widely used in many industrial applications -- can penetrate the lungs more deeply than asbestos and appear to cause asbestos-like, often-fatal damage more rapidly. Other nanoparticles, especially those composed of metal-chemical combinations, can cause cancer and birth defects; lead to harmful buildups in the circulatory system; and damage the heart, liver and other organs of lab animals.
Also in This Series:
- Regulated or Not, Nano-Foods Coming to a Store Near You
- Obsession With Growth Stymies Regulators
- Why Nanotech Hasn't (Yet) Triggered the 'Yuck Factor'
- Nano-Products Are Everywhere
- Primer: How Nanotechnology Works
- Timeline: Nanotech's Evolution
- Chart: Funding Shortchanges Safety
- Key Findings of This Investigation
Yet despite those findings, most federal agencies are doing little to nothing to ensure public safety. Consumers have virtually no way of knowing whether the products they purchase contain nanomaterials, as under current U.S. laws it is completely up to manufacturers what to put on their labels. And hundreds of interviews conducted by AOL News' senior public health correspondent over the past 15 months make it clear that movement in the government's efforts to institute safety rules and regulations for use of nanomaterials is often as flat as the read-out on a snowman's heart monitor.
"How long should the public have to wait before the government takes protective action?" says Jaydee Hanson, senior policy analyst for the Center for Food Safety. "Must the bodies stack up first?"
Big Promise Comes With Potential Perils
"Nano" comes from the Greek word for dwarf, though that falls short of conveying the true scale of this new world: Draw a line 1 inch long, and 25 million nanoparticles can fit between its beginning and end.
Apart from the materials' size, everything about nanotechnology is huge. According to the federal government and investment analysts, more than 1,300 U.S. businesses and universities are involved in related research and development. The National Science Foundation says that $60 billion to $70 billion of nano-containing products are sold in this country annually, with the majority going to the energy and electronics industries.
Both the promise and the potential peril of nanomaterials come from their staggeringly small size, which is highlighted by the chart above. (Note, for example, how it shows that the periods on this page are equal to 1 million nanometers.)
Despite the speed bump of the recession, a global market for nano-containing products that stood at $254 billion in 2005 is projected to grow to $2.5 trillion over the next four years, says Michael Holman, research director of Boston-based Lux Research. Another projection, this one from National Science Foundation senior nanotechnology adviser Mihail Roco, says that nanotech will create at least 1 million jobs worldwide by 2015.
By deconstructing and then reassembling atoms into previously unknown material -- the delicate process at the heart of nanotechnology -- scientists have achieved medical advancements that even staunch critics admit are miraculous. Think of a medical smart bomb: payloads of cancer-fighting drugs loaded into nanoscale delivery systems and targeted against a specific tumor.
Carbon nanotubes, rod-shaped and rigid with a strength that surpasses steel at a mere fraction of the weight, were touted by commentators at the Vancouver Olympics as helmets, skis and bobsleds made from nanocomposites flashed by. Those innovations follow ultralight bicycles used in the Tour de France, longer-lasting tennis balls, and golf balls touted to fly straighter and roll farther.
Food scientists, meanwhile, are almost gleeful over the ability to create nanostructures that can enhance food's flavor, shelf life and appearance -- and to one day potentially use the engineered particles to craft food without ever involving a farm or ranch.
Yet for all the technology's promise and relentless progress, major questions remain about nanomaterials' effects on human health. A bumper sticker spotted near the sprawling Food and Drug Administration complex in Rockville, Md., puts it well: "Nanotech -- wondrous, horrendous, and unknown."
Adds Jim Alwood, nanotechnology coordinator in the Environmental Protection Agency's Office of Pollution Prevention and Toxics: "There is so much uncertainty about the questions of safety. We can't tell you how safe or unsafe nanomaterials are. There is just too much that we don't yet know."
What is known is by turns fascinating and sobering.
The carbon nanotubes in this vial are part of a booming industry. According to one consulting firm, the global market for nano-containing products is projected to grow to $2.5 trillion by 2014.
Nanoparticles can heal, but they can also kill. Thanks to their size, researchers have found, they can enter the body by almost every pathway. They can be inhaled, ingested, absorbed through skin and eyes. They can invade the brain through the olfactory nerves in the nose.
After penetrating the body, nanoparticles can enter cells, move from organ to organ and even cross the protective blood-brain barrier. They can also get into the bloodstream, bone marrow, nerves, ovaries, muscles and lymph nodes.
The toxicity of a specific nanoparticle depends, in part, on its shape and chemical composition. Many are shaped roughly like a soccer ball, with multiple panels that can increase reactivity, thus exacerbating their potential hazards.
Some nanoparticles can cause a condition called oxidative stress, which can inflame and eventually kill cells. A potential blessing in controlled clinical applications, this ability also carries potentially disastrous consequences.
"Scientists have engineered nanoparticles to target some types of cancer cells, and this is truly wonderful," says Dr. Michael Harbut, director of the Environmental Cancer Initiative at Michigan's Karmanos Cancer Institute. "But until we have sufficient knowledge of, and experience with, this 21st-century version of the surgical scalpel, we run a very real risk of simultaneously destroying healthy cells."
When incorporated into food products, nanomaterials raise other troubling vagaries. In a report issued in January, the science committee of the British House of Lords, following a lengthy review, concluded that there was too little research looking at the toxicological impact of eating nanomaterials. The committee recommended that such "products will simply be denied regulatory approval until further information is available," and also raised the concern that while the amount of nanomaterial in food may be small, the particles can accumulate from repeated consumption.
"It is chronic exposure to nanomaterials that is arguably more relevant to food science applications," says Bernadene Magnuson, a food scientist and toxicologist with Cantox Health Sciences International. "Prolonged exposure studies must be conducted."
Given the potential hazards, public health advocates are calling for greater restraint on the part of those rushing nano-products to market. "The danger is there today in the hundreds of nano-containing consumer products being sold," says Jennifer Sass, senior scientist and nano expert for the nonpartisan Natural Resources Defense Council. "Things that are in the nanoscale that are intentionally designed to be put into consumer products should be instantly required to be tested, and until proper risk assessments are done, they shouldn't be allowed to be sold."
David Hobson, chief scientific officer for international risk assessment firm nanoTox, adds that the questions raised by the growing body of research "are significant enough that we should begin to be concerned. We should not wait until we see visible health effects in humans before we take steps to protect ourselves or to redesign these particles so that they're safer."
Hobson says that when he talks to university and industry nano scientists, he sometimes feels as if he's talking with Marie Curie when she first was playing around with radium.
"It's an exciting advancement they're working with," he says. "But no one even thinks that it could be harmful."
More on Why Size Matters
At a weeklong Knight Foundation Science Workshop on nanotechnology at the Massachusetts Institute of Technology in June, five professors -- four from the Cambridge school and one from Cornell University -- dazzled their fellow participants with extensive show-and-tells on the amazing innovations coming out of their labs.
At one point, one played a video of a mouse with a severed spine dragging his lifeless rear legs around his cage. A scaffolding made of nanomaterial was later implanted across the mouse's injury. Further footage showed the same rodent, 100 days later, racing around his enclosure, all four legs churning like mad.
When the five nanotech pioneers were asked about hazards from the particles they were creating, only one said she was watching new health studies closely. The others said size had no impact on risk: No problems were expected, since the same chemicals they had nano-ized had been used safely for years.
It's an argument echoed by researchers and nano-manufacturers around the globe. But those assumptions are challenged by the many research efforts presenting strong evidence to the contrary, among them Trouiller's study, which was published in November.
"The difference in size is vital to understanding the risk from the same chemical," says Schiestl, who was a co-author on the UCLA study. "Titanium dioxide is chemically inert and has been safely used in the body for decades for joint replacements and other surgical applications. But when the very same chemical is nanosized, it can cause illness and lead to death."
Regulators Take a 'Wait-and-See' Approach
Many public health groups and environmental activists fear the government's lethargy on nanotechnology will be a repeat of earlier regulatory snafus where deadly errors were made in assessing the risk of new substances. "The unsettling track record of other technological breakthroughs -- like asbestos, DDT, PCBs and radiation -- should give regulators pause as they consider the growing commercial presence of nanotech products," says Patty Lovera, assistant director of Food & Water Watch. "This wait-and-see approach puts consumers and the environment at risk."
While the agency has many critics, the EPA, for its part, is pursuing an aggressive strategy on nanotechnology. Among nano-titanium dioxide's other uses, the particle is deployed as an agent for removing arsenic from drinking water, and last year, the EPA handed out 500-page books of health studies on the particles to a panel of scientists asked to advise the agency on the possible risk of that practice. (Another EPA science advisory board held hearings into the hazards from nanosilver used in hundreds of products, from pants, socks and underwear to teething rings.) Dr. Jesse Goodman, the FDA's chief scientist and deputy commissioner for science and public health, says that "there is a most definite requirement that manufacturers ensure that the products be safe." But he adds that compliance is essentially voluntary. The FDA takes action only after an unsafe product is reported.The Food and Drug Administration's handling of nano-titanium dioxide provides a more emblematic example of the government's overall approach. Public health advocates and some of the FDA's own risk assessors are frustrated by what they perceive as the agency's "don't look, don't tell" philosophy. The FDA doesn't even make a pretense of evaluating nanoparticles in the thousands of cosmetics, facial products or food supplements that have already flooded the market, even those that boast the presence of engineered particles. Nano Gold Energizing Cream ($420 a jar) and Cyclic nano-cleanser ($80 a bar) are among the many similar products unevaluated by the agency.
Dr. Jesse Goodman, the FDA's chief scientist and deputy commissioner for science and public health, says the exclusion of cosmetics and nutritional supplements from its regulations is what Congress wants. Goodman adds that "there is a most definite requirement that manufacturers ensure that the products be safe" but says that compliance is essentially voluntary, with the FDA taking action only after an unsafe product is reported.
AOL News repeatedly asked what steps the FDA was taking regarding nano-titanium dioxide, whose risks are acknowledged by other regulatory bodies, including the EPA and the NIOSH. The slow-to-arrive answer from spokeswoman Rita Chappelle: "If information were to indicate that additional safety evaluation or other regulatory action is warranted, we would work with all parties to take the steps appropriate to ensure the safety of marketed products."
Chappelle says FDA scientists are conducting research that focuses on nano-titanium dioxide, but declines to offer any details. Several of the agency's own safety experts say they specifically have urged that the engineered structures not be used in any products they do regulate without appropriate safety testing.
Why Nano-Optimists Hold the Upper Hand
Many government investigators join civilian public health specialists in denouncing the scant money that goes to exploring nanomaterials' possibly wicked side effects. The 2011 federal budget proposes spending $1.8 billion on nanotechnology, but just $117 million, or 6.6 percent, of that total was earmarked for the study of safety issues.
The Obama administration says it is being appropriately vigilant about nanotech. "This administration takes nanotechnology-related environment, health and safety very seriously. It is a significant priority," says Travis Earles, assistant director for nanotechnology in the White House Office of Science and Technology Policy. After taking office, he adds, "We were able to immediately increase the spending in those areas."
But Earles, in what has become standard federal practice, is more fixated on nanotech's upsides. "We are talking about new jobs, new markets, economic and societal benefits so broad they stretch the imagination," he says. Yes, "absolutely," there are reasons for caution, he says. "But you can't refer to nanotechnology as a monolithic entity. Risk assessment depends fundamentally on context -- it depends on the specific application and the specific material."
There's some scientific basis for this emphasize-the-positive position. "Every time you find a hazardous response in a test tube, that should not necessarily be construed as a guarantee of a real-life adverse outcome," notes Dr. Andre Nel, chief of the division of nanomedicine at the California Nanosystems Institute at UCLA.
But there are two ways to proceed in the face of such uncertainty. One is to forge ahead, assuming the best -- that this will be one of those times where the lab results don't correlate to real-world experiences. Another is to hit pause and do the additional testing necessary to be sure that sickened lab animals do not portend human harm.
For advocates of more precautions for nanotech, the latter is the only responsible course.
"From cosmetics to cookware to food, nanoparticles are making their way into every facet of consumer life with little to no oversight from government regulators," says Lovera from Food & Water Watch. "There are too many unanswered questions and common-sense demands that these products be kept off the market until their safety is assured."
With a moratorium not a realistic option, the U.S. government, along with its counterparts abroad, is left to tread gingerly in responding to the emerging evidence of nanotechnology's potential hazards.
"They don't want to cause either a collapse in the industry or generate any kind of public backlash of any sort," says Pat Mooney, executive director of ETC Group, an international safety and environmental watchdog. "So they're in the background talking about how they're going to tweak regulations -- where in fact a lot more than tweaking is required.
"They've got literally thousands of [nano] products in the marketplace, and they don't have any safety regulations in place," Mooney continues. "These are things that we're rubbing in our skin, spraying in our fields, eating and wearing. And that's a mistake, and they're trying to figure out what to do about it all."
Return to The Nanotech Gamble home page.

Regulated or Not, Nano-Foods Coming to a Store Near You
Andrew Schneider Senior Public Health Correspondent

Second in a Three-Part Series
(March 24) -- For centuries, it was the cook and the heat of the fire that cajoled taste, texture, flavor and aroma from the pot. Today, that culinary voodoo is being crafted by white-coated scientists toiling in pristine labs, rearranging atoms into chemical particles never before seen.
At last year's Institute of Food Technologists international conference, nanotechnology was the topic that generated the most buzz among the 14,000 food-scientists, chefs and manufacturers crammed into an Anaheim, Calif., hall. Though it's a word that has probably never been printed on any menu, and probably never will, there was so much interest in the potential uses of nanotechnology for food that a separate daylong session focused just on that subject was packed to overflowing.
In one corner of the convention center, a chemist, a flavorist and two food-marketing specialists clustered around a large chart of the Periodic Table of Elements (think back to high school science class). The food chemist, from China, ran her hands over the chart, pausing at different chemicals just long enough to say how a nano-ized version of each would improve existing flavors or create new ones.
One of the marketing guys questioned what would happen if the consumer found out.
The flavorist asked whether the Food and Drug Administration would even allow nanoingredients.
Posed a variation of the latter question, Dr. Jesse Goodman, the agency's chief scientist and deputy commissioner for science and public health, gave a revealing answer. He said he wasn't involved enough with how the FDA was handling nanomaterials in food to discuss that issue. And the agency wouldn't provide anyone else to talk about it.
This despite the fact that hundreds of peer-reviewed studies have shown that nanoparticles pose potential risks to human health -- and, more specifically, that when ingested can cause DNA damage that can prefigure cancer and heart and brain disease.
Despite Denials, Nano-Food Is Here
Officially, the FDA says there aren't any nano-containing food products currently sold in the U.S.
Not true, say some of the agency's own safety experts, pointing to scientific studies published in food science journals, reports from foreign safety agencies and discussions in gatherings like the Institute of Food Technologists conference.
In fact, the arrival of nanomaterial onto the food scene is already causing some big-chain safety managers to demand greater scrutiny of what they're being offered, especially with imported food and beverages. At a conference in Seattle last year hosted by leading food safety attorney Bill Marler, presenters raised the issue of how hard it is for large supermarket companies to know precisely what they are purchasing, especially with nanomaterials, because of the volume and variety they deal in.

According to a USDA scientist, some Latin American packers spray U.S.-bound produce with a wax-like nanocoating to extend shelf-life. "We found no indication that the nanocoating ... has ever been tested for health effects," the researcher says.
Craig Wilson, assistant vice president for safety for Costco, says his chain does not test for nanomaterial in the food products it is offered by manufacturers. But, he adds, Costco is looking "far more carefully at everything we buy. ... We have to rely on the accuracy of the labels and the integrity of our vendors. Our buyers know that if they find nanomaterial or anything else they might consider unsafe, the vendors either remove it, or we don't buy it."
Another government scientist says nanoparticles can be found today in produce sections in some large grocery chains and vegetable wholesalers. This scientist, a researcher with the USDA's Agricultural Research Service, was part of a group that examined Central and South American farms and packers that ship fruits and vegetables into the U.S. and Canada. According to the USDA researcher -- who asked that his name not be used because he's not authorized to speak for the agency -- apples, pears, peppers, cucumbers and other fruit and vegetables are being coated with a thin, wax-like nanocoating to extend shelf-life. The edible nanomaterial skin will also protect the color and flavor of the fruit longer.
"We found no indication that the nanocoating, which is manufactured in Asia, has ever been tested for health effects," said the researcher.

A science committee of the British House of Lords has found that nanomaterials are already appearing in numerous products, among them salad dressings and sauces. Jaydee Hanson, policy analyst for the Center for Food Safety, says that they're also being added to ice cream to make it "look richer and better textured."

Some foreign governments, apparently more worried about the influx of nano-related products to their grocery shelves, are gathering their own research. In January, a science committee of the British House of Lords issued a lengthy study on nanotechnology and food. Scores of scientific groups and consumer activists and even several international food manufactures told the committee investigators that engineered particles were already being sold in salad dressings; sauces; diet beverages; and boxed cake, muffin and pancakes mixes, to which they're added to ensure easy pouring.
Other researchers responding to the committee's request for information talked about hundreds more items that could be in stores by year's end.
For example, a team in Munich has used nano-nonstick coatings to end the worldwide frustration of having to endlessly shake an upturned mustard or ketchup bottle to get at the last bit clinging to the bottom. Another person told the investigators that Nestle and Unilever have about completed developing a nano-emulsion-based ice cream that has a lower fat content but retains its texture and flavor.
The Ultimate Secret Ingredient
Nearly 20 of the world's largest food manufacturers -- among them Nestle, as well as Hershey, Cargill, Campbell Soup, Sara Lee, and H.J. Heinz -- have their own in-house nano-labs, or have contracted with major universities to do nano-related food product development. But they are not eager to broadcast those efforts.
A team in Munich, the House of Lords investigators also learned, is using nano-nonstick coatings to make it easier to get the last drops of ketchup out of the bottle.
Kraft was the first major food company to hoist the banner of nanotechnology. Spokesman Richard Buino, however, now says that while "we have sponsored nanotech research at various universities and research institutions in the past," Kraft has no labs focusing on it today.
The stance is in stark contrast to the one Kraft struck in late 2000, when it loudly and repeatedly proclaimed that it had formed the Nanotek Consortium with engineers, molecular chemists and physicists from 15 universities in the U.S. and abroad. The mission of the team was to show how nanotechnology would completely revolutionize the food manufacturing industry, or so said its then-director, Kraft research chemist Manuel Marquez.
But by the end of 2004, the much-touted operation seemed to vanish. All mentions of Nanotek Consortium disappeared from Kraft's news releases and corporate reports.
"We have not nor are we currently using nanotechnology in our products or packaging," Buino added in another e-mail.
Industry Tactics Thwart Risk Awareness
The British government investigation into nanofood strongly criticized the U.K.'s food industry for "failing to be transparent about its research into the uses of nanotechnologies and nanomaterials." On this side of the Atlantic, corporate secrecy isn't a problem, as some FDA officials tell it.
Investigators on Capitol Hill say the FDA's congressional liaisons have repeatedly assured them -- from George W. Bush's administration through President Barack Obama's first year -- that the big U.S. food companies have been upfront and open about their plans and progress in using nanomaterial in food.
But FDA and USDA food safety specialists interviewed over the past three months stressed that based on past performance, industry cannot be relied on to voluntarily advance safety efforts.
These government scientists, who are actively attempting to evaluate the risk of introducing nanotechnology to food, say that only a handful of corporations are candid about what they're doing and collaborating with the FDA and USDA to help develop regulations that will both protect the public and permit their products to reach market. Most companies, the government scientists add, submit little or no information unless forced. Even then, much of the information crucial to evaluating hazards -- such as the chemicals used and results of company health studies -- is withheld, with corporate lawyers claiming it constitutes confidential business information.
Both regulators and some industry consultants say the evasiveness from food manufacturers could blow up in their faces. As precedent, they point to what happened in the mid-'90s with genetically modified food, the last major scientific innovation that was, in many cases, force-fed to consumers. "There was a lack of transparency on what companies were doing. So promoting genetically modified foods was perceived by some of the public as being just profit-driven," says Professor Rickey Yada of the Department of Food Science at the University of Guelph in Ontario, Canada.
"In retrospect, food manufacturers should have highlighted the benefits that the technology could bring as well as discussing the potential concerns."
Eating Nanomaterials Could Increase Underlying Risks
The House of Lords' study identified "severe shortfalls" in research into the dangers of nanotechnology in food. Its authors called for funding studies that address the behavior of nanomaterials within the digestive system. Similar recommendations are being made in the U.S., where the majority of research on nanomaterial focuses on it entering the body via inhalation and absorption.
The food industry is very competitive, with thin profit margins. And safety evaluations are very expensive, notes Bernadene Magnuson, senior scientific and regulatory consultant with risk-assessment firm Cantox Health Sciences International. "You need to be pretty sure you've got something that's likely to benefit you and your product in some way before you're going to start launching into safety evaluations," she explains. Magnuson believes that additional studies must be done on chronic exposure to and ingestion of nanomaterials.
One of the few ingestion studies recently completed was a two-year-long examination of nano-titanium dioxide at UCLA, which showed that the compound caused DNA and chromosome damage after lab animals drank large quantities of the particles in their water. Sono-Tek, a company based in Milton, N.Y., employs nanotechnology in its industrial sprayers. "One new application for us is spraying nanomaterial suspensions onto biodegradable plastic food wrapping materials to preserve the freshness of food products," says its chairman and CEO.
It is widely known that nano-titanium dioxide is used as filler in hundreds of medicines and cosmetics and as a blocking agent in sunscreens. But Jaydee Hanson, policy analyst for the Center for Food Safety, worries that the danger is greater "when the nano-titanium dioxide is used in food."
Ice cream companies, Hanson says, are using nanomaterials to make their products "look richer and better textured." Bread makers are spraying nanomaterials on their loaves "to make them shinier and help them keep microbe-free longer."
While AOL News was unable to identify a company pursuing the latter practice, it did find Sono-Tek of Milton, N.Y., which uses nanotechnology in its industrial sprayers. "One new application for us is spraying nanomaterial suspensions onto biodegradable plastic food wrapping materials to preserve the freshness of food products," says Christopher Coccio, chairman and CEO. He said the development of this nano-wrap was partially funded by New York State's Energy Research and Development Authority.
"This is happening," Hanson says. He calls on the FDA to "immediately seek a ban on any products that contain these nanoparticles, especially those in products that are likely to be ingested by children."
"The UCLA study means we need to research the health effects of these products before people get sick, not after," Hanson says.
There is nothing to mandate that such safety research take place.
The FDA's Blind Spot
The FDA includes titanium dioxide among the food additives it classifies under the designation "generally recognized as safe," or GRAS. New additives with that label can bypass extensive and costly health testing that is otherwise required of items bound for grocery shelves.
A report issued last month by the Government Accountability Office denounced the enormous loophole that the FDA has permitted through the GRAS classification. And the GAO investigators also echoed the concerns of consumer and food safety activists who argue that giving nanomaterials the GRAS free pass is perilous.
Food safety agencies in Canada and the European Union require all ingredients that incorporate engineered nanomaterials to be submitted to regulators before they can be put on the market, the GAO noted. Not so with the FDA.
"Because GRAS notification is voluntary and companies are not required to identify nanomaterials in their GRAS substances, FDA has no way of knowing the full extent to which engineered nanomaterials have entered the U.S. food supply," the GAO told Congress.
Amid that uncertainty, calls for safety analysis are growing.
"Testing must always be done," says food regulatory consultant George Burdock, a toxicologist and the head of the Burdock Group. "Because if it's nanosized, its chemical properties will most assuredly be different and so might the biological impact."
Will Consumers Swallow What Science Serves Up Next?
Interviews with more than a dozen food scientists revealed strikingly similar predictions on how the food industry will employ nanoscale technology. They say firms are creating nanostructures to enhance flavor, shelf life and appearance. They even foresee using encapsulated or engineered nanoscale particles to create foods from scratch.
Experts agreed that the first widespread use of nanotechnology to hit the U.S. food market would be nanoscale packing materials and nanosensors for food safety, bacteria detection and traceability.
While acknowledging that many more nano-related food products are on the way, Magnuson, the industry risk consultant, says the greatest degree of research right now is directed at food safety and quality. "Using nanotechnology to improve the sensitivity and speed of detection of food-borne pathogens in the food itself or in the supply chain or in the processing equipment could be lifesaving," she says.
For example, researchers at Clemson University, according to USDA, have used nanoparticles to identify campylobacter, a sometimes-lethal food-borne pathogen, in poultry intestinal tracts prior to processing.
At the University of Massachusetts Amherst, food scientist Julian McClements and his colleagues have developed time-release nanolaminated coatings to add bioactive components to food to enhance delivery of ingredients to help prevent diseases such as cancer, osteoporosis, heart disease and hypertension.
But if the medical benefits of such an application are something to cheer, the prospect of eating them in the first place isn't viewed as enthusiastically.
Advertising and marketing consultants for food and beverage makers are still apprehensive about a study done two years ago by the German Federal Institute of Risk Assessment, which commissioned pollsters to measure public acceptance of nanomaterials in food. The study showed that only 20 percent of respondents would buy nanotechnology-enhanced food products.
Return to The Nanotech Gamble home page.

Obsession With Nanotech Growth Stymies Regulators
Andrew Schneider Senior Public Health Correspondent
Third in a Three-Part Series
(March 24) -- When the United States government formally acknowledged the world-changing potential of nanotechnology a decade ago, it was decided that America should lead the way. Almost immediately, 25 different federal agencies began scrambling to find uses for the engineered particles in medicine, energy, transport, weapons, protective devices and food, as well as thousands more real and dreamed-about applications.
Today, the U.S. is at the fore of worldwide nano-innovation. But when it comes to regulations and laws that will protect consumers and workers from the potential hazards, the country lags badly behind many other nations.
"The government agencies responsible for protecting the public from the adverse effects of these technologies seem worn and tattered," former Environmental Protection Agency assistant administrator Clarence Davies wrote in a study for the Woodrow Wilson International Center for Scholars' Project on Emerging Nanotechnologies, where he is now a senior adviser. Davies, who while at the EPA authored what became its all-important Toxic Substances Control Act, adds that the gap between the capabilities of nanotechnology and those of the regulatory system "is likely to widen as the new technologies advance."
Andrew Maynard, chief science adviser for the Woodrow Wilson International Center for Scholars, is among those advocating guidelines for nano-safety. "Get these rules wrong -- and we're not sure what they are yet -- or ignore them, and we may cause unnecessary harm to people and the environment," he says.
Advocates say the importance of establishing effective nano-safety guidance is difficult to overstate. But that effort is also dauntingly difficult.
"Get these rules wrong -- and we're not sure what they are yet -- or ignore them, and we may cause unnecessary harm to people and the environment," says Andrew Maynard, chief science adviser for the Wilson Center. "I don't think it will be the end of the world as we know it. But it will be a lost opportunity to get an exciting new technology right."
No One's in Charge
The U.S. government has no nano czar, no single entity responsible for setting priorities and doling out billions in research funds. But on paper, the National Nanotechnology Initiative comes closest to fitting that role.
Also in This Series:
- Amid Nanotech's Dazzling Promise, Health Risks Grow
- Regulated or Not, Nano-Foods Coming to a Store Near You
- Why Nanotech Hasn't (Yet) Triggered the 'Yuck Factor'
- Nano-Products Are Everywhere
- Primer: How Nanotechnology Works
- Timeline: Nanotech's Evolution
- Chart: Funding Shortchanges Safety
- Key Findings of This Investigation
Launched by the Clinton administration's 2001 budget, the NNI was tasked with coordinating federal investment in nanotechnology research and development. The official description of its mission mandates it to "advance a world-class nanotechnology research and development program, foster the transfer of new technologies into products for commercial and public benefit, and support responsible development of nanotechnology."
While that sounds somewhat czar-like, the reality is that who's in charge of America's nanotech policy is murky.
"Final authority resides in the [White House's] Office of Science and Technology Policy, the Office of Management and Budget, and with the president," says NNI Director Clayton Teague. At the same time, Teague's position is that there's no need for a central, government-wide coordinating entity on nanotechnology. "There is no nuclear 'czar,' no independent authority over information technology, electronic technology, or biotechnology for health and medicine," he says, adding that nanotechnology activities "claim less than 1 percent of the federal research and development budget" and therefore "simply don't require the special focus you are suggesting."
NNI's biggest shortcoming, say even the agency's supporters, is its failure to adequately fund basic research on the safety hazards of nanomaterial.
"The NNI has never effectively addressed environmental, health and safety issues surrounding nanotech with a comprehensive, interagency plan," Matthew Nordan, president of technology forecasting firm Lux Research, told the Senate Committee on Commerce, Science and Transportation. Although his statement was made almost two years ago, committee investigators say there has been little or no improvement since.
The Obama administration's 2011 budget illustrates the scant federal resources devoted to nano-safety. It proposes spending $1.8 billion on nanotechnology overall, but just $117 million -- or 6.6 percent -- of that was earmarked for the study of health-related issues surrounding the engineered particles. "It's not a small amount," says Travis Earles, a nanotech adviser to the White House, defending the allotment.
Without a single office leading the charge, the task of guarding against potential nanotech risks falls to the four agencies most involved in protecting the public, workers and the environment: the EPA, the Food and Drug Administration, the U.S. Department of Agriculture and the Occupational Safety Health Administration.
Many of the safety experts in those agencies told AOL News that the vital regulations for the use, production, labeling, sale and ultimate disposal of nanomaterial are not keeping pace with the rush of new products entering the marketplace.
"Consumers want to know what they buy, retailers have to know what they sell, and processors and recyclers need to know what they handle," Christoph Meili, of the Innovation Society Ltd., said in a report on international nano regulations funded in part by the Swiss Federal Office for the Environment.
Some of the scientists involved in turning nanoparticles into new business opportunities, however, argue that such protocols would be premature.
"I don't think we have the scientific basis on which to establish regulations. And I think that right now a lot of the materials that are being produced are absolutely benign," says Stacey Harper assistant professor of nanotoxicology at Oregon State University.
"The Holy Grail," she says, "is figuring out what are those [hazardous] features that we need to avoid in engineering these newer materials."
'Do Nothing to Prevent Innovation'
The FDA makes stringent demands for safety information on nanomaterial used in medicine and medical devices, says Jesse Goodman, its chief scientist and deputy commissioner for science and public health. But the agency takes no specific measures to ensure the safety of the many costly cosmetics and dietary supplements boasting the benefits of the nanoingredients they claim to include, even though its own investigators say the public submits a constant stream of questions and complaints. "Nanotechnology products present challenges similar to those the [FDA] faces for products of other emerging technologies," says an agency press officer, and "our existing regulations can pretty much handle these advancements."
The FDA (whose Rockville, Md., headquarters are shown here) has drawn fire from activists for its approach to nanomaterials. The agency, says the Center for Food Safety's Jaydee Hanson, is "like ostriches with their heads in the ground, not looking for a problem so they do not see one."
That stated approach terrifies public health advocates, as well as some of the agency's own risk assessors.
"FDA is like ostriches with their heads in the ground, not looking for a problem so they do not see one. If they don't see one, they don't have to respond to a problem," says Jaydee Hanson, senior policy analyst for the Center for Food Safety.
The FDA does need better tools and expertise to predict the behavior of nanomaterial, Goodman concedes. But, he adds, "to get information needed to assess the safety of nano-products, we do that in a way that doesn't cause a problem in terms of preventing innovation."
"Do nothing to prevent innovation" was former Vice President Dick Cheney's marching orders to the Office of Management and Budget during President George W. Bush's administration. "For years OMB acted as industry's protector," says Celeste Monforton, assistant research professor at George Washington University's School of Public Health. She is among the public health activists who cringe to hear the phrase still being used by President Barack Obama's regulators.
For all that, however, the FDA appears most AWOL in its handling of nanomaterial in food. Food safety experts in the agency say it is doing little more than paying bureaucratic lip service to developing criteria for handling the anticipated avalanche of food, beverages and related packaging that is heading to store shelves. (The agency declined repeated requests to interview any of its food scientists or regulators.)
With the FDA largely punting, responsibility for ensuring the safety of the nanomaterial in the marketplace falls to the Consumer Product Safety Commission -- which raises additional problems. "If you take the nano-products that we know are out there and divide them up among the safety agencies, the CPSC is actually responsible for a majority of those," says David Rejeski, science director for the Technology Innovation Program at the Woodrow Wilson International Center for Scholars.
In an analysis of CPSC's ability to handle nanomaterial, Rejeski -- who has worked in the White House Office of Science and Technology Policy -- and his team identified many limitations. The CPSC has no method of collecting information on nano-products, and limited ability to inform the public about health hazards.
"Even if they find a product," Rejeski says, "they don't have much ability to do any research to determine whether it's dangerous."
Finding a Way Around the Roadblocks
Since 2008, the EPA has been attempting to impose some controls on carbon nanotubes, whose myriad industrial applications make them one of the most heavily used engineered particles.
In June, it seemed to have made significant progress toward that goal, issuing a final notice on a process called "Significant New Use Rules," which would have required companies to notify the agency at least 90 days prior to the manufacture, importing or processing of carbon nanotubes.
The move was cheered by the public health community: Studies have shown that multiwalled nanotubes are among the nanomaterials posing potential risks to humans, capable of damaging or destroying the immune system, creating asbestos-like lung disease and causing cancer or mutations in various cells. The advocates heralded the measure as the first clear sign that EPA was going to hold nano developers and users accountable.
Almost immediately, the Washington law firm of Wilmer Hale, while declining to say whom it represented, threw up procedural roadblocks, notifying the EPA that it planned "to submit adverse and/or critical comments on behalf of one or more clients." That was enough to force the EPA to withdraw the new rules.
The EPA resubmitted its proposal. But on Dec. 1, in an unprecedented move, the European Commission's Directorate-General for Enterprise and Industry raised concerns on behalf of a British nanotube maker. Action on the new rule was put off for another three months, with the public comment period running through March. Nevertheless, the EPA believes that by year's end, its new nanotube requirements will be mandatory.
EPA Administrator Lisa Jackson is pushing for reforms that would make it mandatory for companies to report the use of nanomaterials. Industry players are pushing back.
Efforts such as those undertaken by Wilmer Hale's client to stall or thwart new or enhanced safety regulations are legal. So is another practice used by many corporations to deny EPA access to health studies and other information crucial to assessing the risk of a new chemical or product: declaring that the data is confidential business information.
EPA Administrator Lisa Jackson has said she wants to put an end to the corporate maneuvering, especially as it applies to the new nanomaterial. While testifying before a Senate committee in December attempting to add teeth to the Toxic Substances Control Act, Jackson explained the obstacles EPA risk assessors confront in trying to do their jobs.
Due to the legal and procedural hurdles in the law, over the past 30 years, the administrator said, EPA has only been able to require testing on about 200 of the more than 80,000 chemicals produced and used in the United States.
"EPA should have the clear authority to establish safety standards that reflect the best available science ... without the delays and obstacles currently in place, or excessive claims of confidential business information," Jackson told the lawmakers. In February, the agency's assistant inspector general, Wade Najjum, issued a report that said "EPA's procedures for handling confidential business information requests are predisposed to protect industry information rather than to provide public access to health and safety studies."
The changes to the Toxic Substances Control Act that Jackson is advocating would require mandatory reporting of the use of nanomaterials. EPA lawyers have told Senate investigators that the overhaul is vital due to the industry pressure spawned by the big business opportunities new nano-products can generate. Meanwhile, some nanotechnology players are pushing hard to get a resistant EPA to grandfather in nanomaterial already on the market. It's a significant point of dispute: One of the reasons the EPA is seeking the mandatory reporting requirement in the first place is that the agency is convinced the current voluntary system of submitting safety data doesn't work. In the fall, EPA assistant administrator Steve Owens told an international conference on regulating nanomaterial that about 90 percent of the various nanoscale materials already being used commercially, or thought to be used, were never reported to the government.
"EPA has determined that regulating existing nanoscale materials," explains press officer Dale Kemery, "is needed to ensure protection of human health and the environment."
A spokesman for the Senate Committee on Environment and Public Works says two more hearings need to be held on revising the Toxic Substances Control Act, but they have yet to be scheduled.
Workers Require Extra Protections
If there is a frontrunner in the effort to institute meaningful safety regulations for nanomaterial, it is the National Institute for Occupational Safety and Health, the worker safety research arm of the Centers for Disease Control and Prevention. Physicians and scientists there have been scrambling to identify the risks that the nanotechnology industry's employees are encountering on the job. "Workers and employers can't wait for us to come up with all the answers before they unleash this technology. It's unleashed already," says Paul Schulte, manager of the NIOSH Nanotechnology Research Center.
Having published more than 170-peer-reviewed studies on the health effects from nano exposure, the agency has established exposure limits for nano titanium dioxide -- the heavily used material shown to damage and destroy DNA and chromosomes in studies at UCLA. The division has recommended that to ensure safety, the exposure limit for workers handling nano-titanium dioxide should be 15 times lower than that for the normal size of the chemical, says Vincent Castranova, the agency's chief of the Pathology and Physiology Research Branch.
The particles are believed to be used in more than 100 different manufacturing sites across the country. That's a lot workers.
NIOSH cannot pass laws, only make recommendations to the Occupational Safety and Health Administration. And because of all the tortuous, bureaucratic steps that still must be completed, as well as the anticipated blocking efforts from some industry interests, it could be two years before any regulations are instituted. OSHA leaders refused to respond to questions on what the agency will do in the meantime.
NIOSH has also almost completed recommendations for the handling of carbon nanotubes. And scientists at NIOSH's animal labs in Morgantown, W.Va., are now testing the toxicity of almost two dozen other nanoparticles, including the diesel additive cerium oxide; the metal hardening mixture of tungsten carbide and cobalt; the anti-microbial agent nanosilver; and the sunblocker zinc oxide.
Since 2008, the EPA has also been seeking to impose some controls on carbon nanotubes. That effort has been made more difficult by corporate maneuvering.
Most significantly, NIOSH scientists have identified health risks from nanomaterials not previously documented by other researchers.
For example, says Castranova, when studying the potential impact of nano-titanium dioxide exposure on workers' lungs, they also found cardiovascular effects -- damage to the heart muscle.
Separately, the NIOSH team discovered that beyond the well-documented lung damage that comes from inhalation of carbon nanotubes, those heavily used carbon structures were causing inflammation of the brain in the test animals.
"Everything we say could apply to a consumer. The big difference is that the consumer will likely see much lower concentrations, for much shorter periods of time," Castranova says, adding that the findings need to be viewed with the proper perspective.
Nanomaterials, Castranova says, are not anthrax, but they aren't Kool-Aid, either.
Other Countries Exercise Greater Caution
Consumer and safety watchdogs say Canada, the U.K. and the rest of the European Union are far ahead of the U.S. when it comes to nano safety requirements.
Canada became the first country to demand stringent reporting requirements of corporations and universities that import, manufacture or use more than 2 pounds of nanomaterial a year. The regulations -- necessary for proper risk assessment, the Canadian government said -- were crafted and are enforced by Health Canada and Environment Canada. They require the reporting of the nanomaterial's chemical composition and physical description, toxicity and proposed use, along with other data.
French lawmakers have drafted legislation with similar stipulations. And the European Parliament voted last year that its 27 member states should consider nanomaterials as new substances, and not cover them under existing laws that do not take into account the risks associated with the technology. It also demanded that consumer products containing nanomaterials be clearly labeled as such, and that the manufacturers of new cosmetic products containing nanomaterials provide specific information to regulators six months before the product is placed on the European market.
In the U.K., the battle cry of nano-regulators is "No data, no market," especially with food products.
"Products will simply be denied regulatory approval until further [safety] information is available," the British House of Lords' science committee said in December. It concluded that there was too little research into the toxicological impact of eating nanomaterials, and too much secrecy on the part of the food industry.
"It's obvious that in some cases the U.S. has been a bit lax, though you could make the case that in some cases the EU requirements are a little bit too stringent," says Michael Holman, research director of Lux Research. "There's no regulatory regime that can give you 100 percent certainty that everything that comes to market is going to be perfectly safe."
But to Patty Lovera, assistant director of Food & Water Watch, that doesn't leave the U.S. government off the hook. The failure of the U.S. regulatory system to keep up with nanotechnology, she states simply, "puts consumers and the environment at risk."
Return to The Nanotech Gamble home page.

EPA to Streamline Drinking Water Regs, Tighten Standards for 4 Carcinogens
Published: March 22, 2010

U.S. EPA Administrator Lisa Jackson announced new strategies today aimed at curbing contaminants in drinking water.
The agency's new approach seeks to streamline decisionmaking while expanding protections, Jackson told a gathering of metropolitan water suppliers in Washington, D.C.
The strategy, Jackson said, contains four key components: addressing contaminants in groups rather than individually, fostering the development of new treatment technologies, using multiple statutes to safeguard water supplies, and enhancing state and local partnerships.
"It's an approach that works within existing law and capitalizes on the idea of new innovations," Jackson told the Association of Metropolitan Water Agencies' annual conference. "The plan does not require more regulation, but uses our existing regulations more efficiently and more effectively."
EPA's current approach to protecting drinking water involves assessing each individual contaminant, which can take many years, according to the agency. The new strategy seeks to achieve protections more quickly and cost-effectively with strategies like advanced treatment technologies that address several pollutants at once.
Additionally, Jackson said, the agency plans to use programs in tandem to address water pollution, rather than view them in so-called silos. Jackson said EPA can use the Federal Insecticide, Fungicide and Rodenticide Act, which regulates pesticides, as well as the Toxic Substances Control Act to assess the risk of chemicals and stop contaminants before they get into drinking water.
EPA today also announced a decision to revise the existing drinking water standards for four contaminants that can cause cancer.
After a recent scientific review, the agency has decided to tighten regulations for the carcinogenic compounds tetrachloroethylene, trichloroethylene, acrylamide and epichlorohydrin.
Tetrachloroethylene and trichloroethylene are used in industrial and textile processing and can enter drinking water from contaminated ground water or surface water. Acrylamide and epichlorohydrin are impurities that can enter drinking water during water treatment.
Within a year, EPA plans to initiate a rulemaking to revise the tetrachloroethylene and trichloroethylene standards using the agency's new strategy. EPA will later revise the epichlorohydrin and acrylamide standards and will consider whether the new streamlined approach is appropriate.

Raw Milk Sales - Retailer Knowledge of Risk and Liability

Posted on March 24, 2010 by David Babcock
The comments posted on line following most news stories related to "raw milk" are both voluminous, and fairly predictable. Raw milk supporters are nothing if not committed and vocal, and it seems they miss few opportunities to have themselves heard. This recent article, including a quote from Bill Marler, is no different.
The continuing proliferation of information concerning raw milk, though, may well serve to turn up legal pressure on retailers who chose to carry raw milk. For example, in many states, Washington being one, retailers who do not manufacture a product are not generally held to the strict liability standards applied to the manufacturer. (R.C.W. 7.72.040). In such cases though, retailers will be held liable for negligence. As a general rule, negligence is defined as falling below the standard of care of a reasonable person, or in this case retailer. Irrespective of which "side" of the fence a retailer stands on the raw milk debate, it gets harder and harder to claim reasonableness in the face of quotes like this:

Rob Tauxe, a deputy director at the Centers for Disease Control and Prevention: 'unpasteurized milk "was the No. 1 food safety problem in the nation."
Bill Keene, senior epidemiologist, Oregon Division of Public Health: "If you pass a law that makes it easier to buy raw milk, you certainly will have more instances of illnesses and deaths. That's inevitable. I think after a few dead kids, people will lose their enthusiasm for raw milk. We know that raw milk is a high-risk product, and that a low-risk alternative (pasteurized milk) was introduced 80 years ago. So if you are trying to thumb your nose at medical science, then good luck to you."
FDA official John Sheehan: "Raw milk is inherently dangerous. It should not be consumed by anyone, at any time, for any reason."
The American Medical Association (AMA): "all milk sold for human consumption should be pasteurized."
Raw milk supporters see these quotes, and many more like them, as evidence of a conspiracy spurred on by big dairy. Retailers have to recognize though, that a jury is not likely to be so quick to dismiss these mainstream agencies, associations, and officials in this manner.
The retail price that raw milk will bear on the marketplace is no doubt an incentive to retailers to carry the product. Before they do so, however, they should think long and hard about their liability for doing so.

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