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Final Guidance for Industry on Studies to Evaluate the Safety of Residues of Veterinary

Transcript Of Press Gaggle With Agriculture Secretary Mike Johanns - Washington, DC

Joint Statement by Secretary Mike Johanns and Minister Andrew Mitchell
Statement By Agriculture Secretary Mike Johanns

FDA Proposes $1.9 Billion Budget to Expand Food Defense Effort


2006 FDA budget would expand food defense effort
Source of Article:
2/08/2005-The 2006 fiscal year budget requested by the Food and Drug Administration (FDA) includes an increase of $30.1 million to defend the U.S. food supply from terrorist attacks.
The FDA's portion is only part of the food defense effort, which also involves the USDA's Food Safety & Inspection Service (FSIS), the Department of Homeland Security (DHS) and the White House Homeland Security Council. The total budget authority for items related to food defense has increased 20 percent, to $180 million from $150 million.
The proposed increase for the food counter-terrorism program includes funds for long-range projects by FDA and FSIS including:

Expansion of the joint FDA-FSIS Food Emergency Response Network (FERN) of laboratories capable of analyzing thousands of food samples for biological, chemical and radiological threats. The FY 2006 budget would add an estimated 19 FDA-funded state labs. Nearly two-thirds of the requested $30 million requested would be spent on FERN.

Targeted research in those areas posing the greatest perceived threat to the food supply, as well as research related to prevention/mitigation technologies, tamper proof packaging, rapid test methods, and/or agent sensor technologies.

Continued coordination and data-sharing with the DHS as part of the government-wide Bio-Surveillance Initiative; and

Sustained development of the FDA's crisis- and incident-management infrastructure, which is required to manage emergencies involving FDA-regulated products.

USDA error may delay Canada cattle trade
Feb. 11/05
By Charles Abbott
WASHINGTON - Democratic Sen. Kent Conrad of North Dakota was cited as saying on Friday that a procedural misstep by the Bush administration may require a delay in its plan to resume imports of some beef and cattle from Canada on March 7, because the U.S. Agriculture Department failed to notify the Senate of its trade regulation, despite being required by law to do so, Congress has the power to review major regulations and can overturn them.
Department spokeswoman Alisa Harrison was quoted as saying, "As far as the administration is concerned, we submitted it properly. We consider March 7 to still be the effective date."
Harrison gave to reporters copies of a receipt signed by Vice President Dick Cheney's office on Jan. 4 to accept the formal notice of the rule. The vice president's office routinely accepts filings on behalf of the Senate, she said.
It was unclear what happened afterward.
Clerical officials in the Senate could not say if they had received the notification. An Internet search of the Congressional Record found no reference to the regulation in Senate activities, although it was cited among "executive communications" in the House on Feb. 1.
Conrad was further cited as saying the procedural problem was discovered when he and several other senators tried to file a resolution on Thursday to void the USDA rule.
A search of the Congressional Record by Internet on Friday found a reference to the USDA rule among "executive communications" to the House of Representatives but no similar mention in the Senate.

Japanese newspaper predicts border will not open to U.S. beef until summer's end

by Pete Hisey on 2/11/05 for
Citing internal disagreements within Japan's Food Safety Commission, a complicated process to revise the country's law that all cattle slaughtered must be tested for bovine spongiform encephalopathy and recent events such as the death of a Japanese man from variant Creutzfeldt-Jakob disease, Japanese newspaper the Asahi Shimbun predicted that the market would not open to American beef until the end of the summer at the earliest."Optimists say the decision (to accept American beef graded A40) should help to accelerate work to change domestic safety standards," the paper said. "But that is not the case."
A review of the system is underway, but "has taken much longer than expected." Even if the panel conducting the review were to recommend ending the requirement to test cattle under 20 months of age, there is no certainty that the Food Safety Commission would approve it.Meanwhile, Japan and the United States will hold meetings soon at which Tokyo will present Washington with a list of requirements the Japanese want met in confirming the age of cattle and other safeguards against infection. No date has been set for the meetings, according to an Agricultural Ministry official.

USDA Changes Course On Canada Beef Trade
The Bush administration on Wednesday said it will withdraw a plan to allow imports of Canadian beef from older cattle starting on March 7, bowing to U.S. meatpackers' complaints. However, on that date the border will still reopen to live Canadian cattle under 30 months of age, which are viewed as unlikely to carry mad cow disease or bovine spongiform encephalopathy (BSE). All Canadian cattle have been banned for import since May 2003, following the discovery of Canada's first domestic case of mad cow disease.
USDA's reversal on imports of beef from older Canadian cattle came after a spirited lobbying campaign by American meatpackers. They complained the plan would have increased the flow of cheap Canadian beef at a time when U.S. plants were shutting down due to a shortage of live cattle. Complicating matters was Canada's discovery of two more cases of mad cow disease around the time the U.S. government unveiled its plan to ease trade restrictions. ``Our ongoing investigations into the recent finds of BSE in Canada in animals over 30 months are not complete. Therefore, I feel it is prudent to delay the effective date for allowing imports of meat from animals 30 months and over,'' U.S. Agriculture Secretary Mike Johanns said.
However, Johanns said he would initiate a process that could lead to the opening of the U.S. border to Canadian cattle over 30 months as well as beef from those older animals. USDA officials would not speculate on how long that might take. Some government and industry officials have estimated it could be at least a few months. In August 2003, USDA ended a blanket ban on Canadian beef when it opened the border to boxed beef from young cattle, a product thought to have the lowest BSE risk. The USDA emphasized it will stick to the rest of its plan, announced on Dec. 29, to reopen the border to Canadian cattle under 30 months old. ``We still plan to implement that part of the rule,'' USDA spokesman Ed Loyd said.
The cattle ban has been a hardship for U.S. meatpacking plants, which previously imported more than 1 million live Canadian cattle annually to keep plants operating efficiently.Wednesday's announcement came after Canadian Agriculture Minister Andy Mitchell met with Johanns and farm-state senators. Mitchell said he was ``pleased'' that USDA will now consider allowing imports of older Canadian cattle.
Sen. Tom Harkin of Iowa, the senior Democrat on the Senate Agriculture Committee, has urged USDA to completely scrap expanded beef or cattle trade with Canada.
While he called the new USDA decision ¡°a significant step in the right direction,'' Harkin continued to voice doubts about Canada's compliance with international mad cow safeguards.
Sen. Richard Lugar, a Republican from Indiana, said USDA's move ``probably bought a little time to mollify people'' while Johanns continues to persuade Japan to accept U.S. beef.
Japan was the top importer of American beef until the United States confirmed its first case of mad cow disease at the end of 2003.
Cattle traders have been keeping close watch on USDA's plans for reopening the border to Canadian beef and cattle.
``It is a positive thing for the market, but I think it has been anticipated,'' said Jim Clarkson, analyst with Chicago-based A. and A. Trading. Clarkson doubted there will be much price reaction in cattle futures trading on the Chicago Mercantile Exchange on Thursday.
The issue has also been targeted in court.
An activist U.S. cattle group, R-CALF USA, asked a federal judge in Montana to stop the movement of any Canadian cattle into the United States. Meanwhile, the American Meat Institute, representing meatpackers, has sued to remove all Canada trade barriers. 2-9-05


Northwest Food Processors Food Safety News February 9, 2004
The Environmental Protection Agency says that exposure to even low levels of perfl uorooctanoic acid and its salts, known as PFOA, or C-8, used to make the nonstick substance Tefl on, could pose ¡°a potential risk of developmental and other adverse effects.¡±
Charles Auer, director of EPA¡¯s Offi ce of Pollution Prevention and Toxics emphasized that their draft risk
assessment was not conclusive, adding, ¡°We¡¯ve not offered any determinations of risks,¡± and that the draft report,
based on animal studies, would be sent to a science advisory board for helping determining the risks.
DuPont and EPA have been sparring over PFOA, used to make many of the company¡¯s most popular products,
which range from auto fuel systems, fi refi ghting foam and phone cables to computer chips, cookware and clothing.
Chemical maker DuPont Co., which is based in Wilmington, Del., and produces the chemical at a plant in Fayetteville, N.C., said it welcomed EPA¡¯s report and was trying to minimize people¡¯s exposure to the chemical, adding, ¡°Although, to date, no human health effects are known to be caused by PFOA, the company recognizes that the presence of PFOA in human blood raises questions that should be addressed.¡±
Source: AP 1/12/05

Biosensors can help stem spread of infectious diseases after disasters
January 31, 2005
University of South Florida
Biosensors developed at the University of South Florida lab of Luis Garcia-Rubio, a chemical engineer at the university¡¯s College of Marine Science, can detect infectious diseases in blood and bodily fluids as well as identify pathogenic microorganisms in contaminated water. The new sensors could be our most effective future frontline defense against diseases emerging after disasters such as the recent tsunami, as well as help reduce the every day, annual rates of illness and deaths caused by contaminated water and unsanitary conditions world-wide.
¡°In the wake of the recent tsunami, it was anticipated that infectious diseases could increase dramatically in affected areas,¡± Garcia-Rubio said. ¡°Public health officials rightfully fear thousands more will die from infectious water-borne and water related diseases after the tsunami. When people are forced to live in crowded refugee camps, they are more easily exposed to infectious diseases that spread quickly due to a lack of clean drinking water and unsanitary conditions.¡±
The CMS research group, comprised of engineers, physicists microbiologists and chemists, is now testing portable, miniaturized biosensors that can - in real-time and continuously - monitor for a number of infectious diseases using as little as a single drop of blood. The sensors then wirelessly teleport data to a remote location for analysis..
¡°By optically identifying how an organism absorbs and scatters light, our new, minimally invasive technology identifies the light wave spectrum in a sample collected on-site,¡± explained Garcia-Rubio. ¡°Because each organism absorbs and scatters light differently, we can analyze the light wave spectrum and scatter pattern and identify an organism in the sample by comparing those patterns with known, cataloged samples.¡±
Up to now, said Garcia-Rubio, without expensive processes and highly trained personnel, there have been no portable instruments capable of detecting and classifying either microorganisms or cells in real time.
After patenting their technology, the research group has moved into field experiments with confidence that in the near future their advancement will be available to help public health officials rapidly detect not only infectious diseases, commonplace after natural disasters like the recent tsunami, but also waterborne pathogens that can occur in the drinking water of developed countries, including the United States.
According to Debra Huffman, a collaborator of Garcia-Rubio¡¯s lab, the new biosensors can detect malarial parasites, the dengue virus that causes dengue fever, e. coli, salmonella, shigalla and listeria as well as causes of bacterial dysentery, such as cryptosporidium (protozoan parasites). The sensors can also identify bacillus antrhacis, anthrax that can be weaponized by terrorists.
¡°Development and implementation of portable cost effective technologies for the early and rapid diagnosis of pathogenic microorganisms and infectious diseases is the best way to stem the spread of disease following an environmental disaster,¡± said Garcia-Rubio. ¡°However, the new technology can also help prevent the yearly illnesses and deaths resulting from contaminated water supplies both globally and here in the U.S.¡±
It doesn¡¯t take a tsunami to cause widespread illnesses resulting from contact with contaminated water.
¡°The World Health Organization reported in 2002 that there are nearly two million deaths annually related to unsafe water and poor sanitation and hygiene,¡± pointed out Huffman. ¡°The majority of those deaths are among children under five years of age.¡±
According to Huffman, diarrhoeal diseases account for one-third of illnesses globally and are the sixth leading cause of deaths world-wide.
¡°Natural disasters notwithstanding, one sixth of the world¡¯s population lacks good access to safe water,¡± she said.
The new biosensors can help reduce those rates.

Food Allergy Initiative Sponsors an Educational Symposium
Source: Food Allergy Initiative
Food Allergy Initiative Sponsors an Educational Symposium: Understanding and Managing Your Child's Food Allergy
Thursday February 10
Source of Article:

NEW YORK, Feb. 10 /PRNewswire/ -- Did you know that a grandmother's kiss can cause an allergic reaction in her food allergic child? Parents of children with food allergies have safety concerns that go above and beyond those of other parents. To help them keep their children out of harm's way, the Food Allergy Initiative (FAI) sponsored an Educational Symposium, "Understanding and Managing Your Child's Food Allergy," presented by The Elliot And Roslyn Jaffe Food Allergy Institute at Mount Sinai School of Medicine on Thursday, February 10, 2005. Dr. Hugh A. Sampson, Division Chief, Pediatric Allergy and Immunology at the Mount Sinai School of Medicine, and a panel of clinicians and researchers at the Institute, addressed the most pressing issues facing food allergic families-how to keep children with life-threatening food allergies alive until a cure is found. The clinical faculty, nurse and dietitian also discussed how food allergy and anaphylaxis are diagnosed and treated, how to manage food allergies in schools, and issues in maintaining a well-balanced diet for children with food allergies. An additional highlight was a review of cutting-edge food allergy research being conducted at the Institute. Over 100 parents, school nurses, pediatricians and others caring for food allergic children were in attendance.
Food allergies are extremely serious because an even a miniscule amount of the wrong food can result in anaphylaxis, a rapid, immune-mediated, systemic reaction to allergens that may result in death. At present, there is no cure for anaphylaxis or food allergies. Until a cure is found, education is the key to helping the 11 million children and adults who live in fear of eating the wrong food. FAI is a national, non-profit organization dedicated to finding a cure for life-threatening food allergies and anaphylaxis by 2010. In addition to funding research and clinical activities to identify and treat those at risk, FAI supports public policy initiatives to create safer environments for those afflicted, and educational programs to heighten awareness among health and child care workers, schools, camps, and members of the hospitality and foodservice industries about food allergies and the danger of anaphylaxis. The Elliot and Roslyn Jaffe Food Allergy Institute at the Mount Sinai School of Medicine is located in New York City. It was established in 1997 as the world's first dedicated food allergy center for comprehensive patient care and research. It remains the premier Center of Excellence, providing state-of- the-art diagnosis and treatment in a compassionate and child-friendly manner. Hugh Sampson, MD, an internationally recognized allergist and investigator of food allergy, directs the Institute. In addition, The Jaffe Food Allergy Institute is the leading center for research in food allergy and publishes more research studies on food allergy than any other single program in the world. The Institute also recognizes a responsibility to educate other physicians about food allergy. Therefore, the Institute faculty trains allergists-in-training and other physicians on diagnosis and management of food allergy. For further information about the symposium, please contact Rachel Sanzari, MS, RD at (212) 527-5835. For information about the Food Allergy Initiative, visit .

It's mad cow madness
: Ottawa has been too slow to take all the steps necessary to control BSE
February 14, 2005
Maclean's 38
Brian Bergman
Recent disclosures of more mad cows in our midst, according to this story, raise the nagging question of why Canada is not doing far more to screen the nation's cattle herds for the dreaded bovine spongiform encephalopathy, better known as mad cow disease.
The story says that the reason we're seeing more confirmed BSE cases is that surveillance is on the upswing, with the Canadian Food Inspection Agency this year testing 30,000 slaughtered cows for BSE, up from 5,490 in 2003. But that's still a rather thin slice, when you consider the Canadian beef industry slaughters over three million animals annually. And it pales beside efforts in Europe, where every slaughtered cow over 30months of age is tested, or Japan, where all slaughtered cows are tested, period. One begins to wonder: how many more diseased animals would emerge if we followed their examples? And are we afraid to find out?
The story says that long before the first Canadian-born mad cow surfaced in May 2003, independent scientists who study brain-wasting conditions were urging federal authorities to pre-emptively step up surveillance. They warned that, because BSE has such a lengthy incubation period -- four to five years -- untold numbers of animals could be exposed to the disease before a single case came to light. Their appeals fell on deaf ears.
David Westaway, a University of Toronto molecular biologist who has spent two decades studying prions, was cited as saying he believes Canada should follow Europe's lead and test all slaughtered cows over 30 months (older cattle are more likely to show signs of BSE), meaning the screening about 500,000 animals annually, or about 17 times the current number, adding, "We have to see what the real incidence is, rather than what one hopes or guesses it is."
Others, including many ordinary ranchers, would like to go further, and test all animals regardless of age. This view is endorsed by Stanley Prusiner, a professor of neurology and biochemistry at the University of California, who won the 1997 Nobel Prize in medicine for his research into prions. In a recent article for Scientific American, Prusiner wrote: "I see no other option for adequately protecting the human food supply."

Cause of outbreak at school revealed
Published: February 10, 2005
Source of Article:
An outbreak last week of gastrointestinal illness at San Andreas Elementary School was caused by the highly contagious norovirus, county health officials confirmed yesterday. The virus is transmitted primarily through consumption of food contaminated by an ill person who uses poor hygiene and by direct person-to-person contact, health officials said. It hasn't been determined if the outbreak was spread through food, but Public Health Officer Dr. Dean Kelaita said almost everyone who had the illness at San Andreas Elementary ate at the school's cafeteria for lunch. Norovirus is the name for a group of viruses described as "Norwalk-like viruses," so called because of a gastroenteritis outbreak in a school in Norwalk, Ohio in 1968, according to the U.S. Centers for Disease Control. County Public Health Director Colleen Tracy said once one person in a family becomes sick with the illness, the entire family usually becomes sick, too, because the virus is highly contagious. The same virus may be cropping up on a much smaller scale at other schools in Calaveras Unified School District, Kelaita said. An ill student from Jenny Lind Elementary School in Valley Springs has it, he said."Noroviruses are very infectious, so we expected that surveillance at other schools would result in additional cases being found," Kelaita said.Last Friday, San Andreas Elementary officials said 25 percent of the student population ? 90 children ? were out sick. About 60 of those are believed to have had the norovirus. The illness is not serious in most people and can last from eight hours to a few days. The main symptoms are rapid onset of vomiting or diarrhea and stomach cramps. Fever, headache and body aches may be present, too. The CDC estimates at least 50 percent of all foodborne outbreaks of gastroenteritis can be attributed to noroviruses. Of 232 norovirus outbreaks reported to CDC from July 1997 to June 2000, 57 percent were foodborne, 16 percent were due to person-to-person spread, and 3 percent were waterborne. In 23 percent of outbreaks, the cause of transmission was not determined.The outbreaks were mostly associated with restaurants, catered meals, nursing homes, schools, and vacation settings or cruise ships. The Public Health Department notified parents of students in the Calaveras Unified School District to keep students home if they develop symptoms. Anyone who gets the illness should stay home for at least 48 hours after symptoms end, health officials said. Kelaita advised families to prevent the spread of the illness by keeping children home if they are vomiting or have diarrhea, and keeping them home at least 48 hours after symptoms stop. Good hand-washing should be practiced ? hands should be scrubbed with soap for at least 30 seconds before rinsing and household disinfectant should be used to thoroughly clean any areas where vomiting or diarrhea occur. For more information, contact the Calaveras County Public Health Department at 754-6460.

Piece of wood is key to beating superbug
Source of Article:

A CHANCE meeting with a student who was chewing on a piece of wood has sparked a major breakthrough in food safety. Researchers at the city¡¯s Heriot-Watt University have discovered that chemicals in teak wood - including a mystery substance - seem to be resistant to the superbug MRSA and listeria. Microbiology professor Brian Austin decided to experiment following a conversation with PhD student Abda Neumatallah, who was using a traditional teak-wood chewing stick.People in the Middle East and Africa have chewed on certain types of wood for centuries in the belief that it prevents tooth decay. Prof Austin studied the claims and found that there was evidence that teak could kill bacteria. He has now developed a new way to smoke fish which prolongs its shelf-life and researchers now plan to pitch the findings to food industry bosses. An expert in aquaculture, marine biotechnology and mathematical biology, Prof Austin is most excited about finding what may be a previously unknown chemical. He said: "I queried one of my PhD students about a stick of wood he was chewing."He is from Saudi Arabia, and told me that chewing of certain woods, including the teak stick he was using, was a traditional way to avoid dental caries in the Middle East and Africa. "Intrigued, we conducted a series of experiments on teak wood and managed to extract two compounds, one already known from walnuts and one which seems to be new. "Then, since we specialise in fish breeding and some manufacturing techniques, we decided to add some teak, about ten per cent, to the usual oak chips as part of our fish-smoking research. "We were delighted to discover that the fish smoked this way stayed fresh longer and that all bacteria was eliminated, even when we cheated and added extra bacteria."Prof Austin now plans to conduct more experiments with co-supervisor Dr Susan Dewar.The team will also speak to commercial fish smokers about their discoveries and how they might be applied in the industry. Listeria is a bacteria that causes an infection known as listeriosis. Listeria infections are rare, but pregnant women who have a listeria infection can become ill and their baby may die or be born prematurely. The findings could also be used to help tackle MRSA. Scotland¡¯s hospitals have some of the highest MRSA rates in the developed world. Leading microbiologist Professor Hugh Pennington said the discovery was a sign of researchers going "back to basics". He said: "We were told around ten years ago to stop using wooden chopping boards but then we discovered that they actually work in our favour. "People have gone back to dealing with traditional remedies and this is a real back-to-basics story."

U.K. Goat, Killed in 1990, May Have Had BSE, Government Says
Source of Article:
Feb. 8 (Bloomberg) -- A Scottish goat, slaughtered in 1990, may have had bovine spongiform encephalopathy, also known as mad- cow disease, the U.K. agriculture department said.
The suspected case follows last month's first confirmed instance of the brain disease in a goat; that case involved a French goat killed in 2002.
Mad-cow disease was first diagnosed in the U.K. in 1986 and was transmitted to cattle through feed that included ground-up parts of infected animals. An epidemic of BSE in British cattle peaked at 36,680 cases in 1992 and resulted in the slaughter of millions of animals.
The Department for Environment Food and Regional Affairs ``will be stepping up its surveillance program for goats,'' the department's Chief Veterinary Officer Debby Reynolds said in an e- mailed statement. ``There is a distinct possibility that the animal, if infected with BSE, was exposed to contaminated feed.''
The department said it can't be certain that the U.K. goat had BSE until further tests have been conducted and that it may take as long as two years before the findings can be confirmed.
The European Union's executive arm said Jan. 28 that a French goat had BSE and announced a more extensive testing program for the animals. Consumers shouldn't change their eating habits as a result of the discovery, the EU said at the time.

Sheep, Goats, Cattle

Laboratory tests have shown that it is possible for sheep, as well as goats and cattle to contract BSE. The latter two are more likely to have been fed a high protein diet including remains of other animals in order to bolster their milk production, according to Peter Hardwick, International manager of the U.K. Meat and Livestock Commission.
``There are significant differences in the way that sheep are reared and the way that goats are reared,'' Hardwick said. In addition scientists have managed to breed sheep with enhanced immunity to brain diseases similar to BSE.
A human variant of BSE, Creutzfeldt-Jacob disease, caught by eating infected beef, has been responsible for more than 130 human deaths in the U.K. since 1990. The disease, which is always fatal, causes progressive loss of mental function and impairs movement.
Following the U.K. outbreak, the commission introduced measures in sheep, goats and cattle to limit recurrences such as banning the use of meat and bone meal as feed.
Greece, Spain and France had the biggest goat populations among the 15 members that comprised the EU in 2003.

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