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3/31
2006
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-FDA's Accomplishments in 2005
-FDA's Accomplishments in 2005

Current Outbreak Summary
To view the articles, click here to enter outbreak news

03/30. Toxic strains of botulism identified
03/30. Mushrooms suspected as 5 in family fall ill
03/30. Hepatitis diagnosed in fourth student
03/30. Restaurant sued in E. coli cases
03/30. California film workers file suit in hepatitis A case
03/30. Bacterial illness linked to raw milk infecting more people
03/29. HURLEY SUFFERS FOOD POISONING
03/29. Food poisoning claims two lives in Gulbarga
03/29. Cruise ship told to follow own rules after outbreak
03/28. Woman claims she got salmonella in hospital
03/28. Hepatitis appears in second school
03/27. Botulism patients still critical
03/27. New case of E.coli infection
03/26. DoH warns on rise in cases of Hepa A in summer
03/26. Three elementary school students test positive for hepatitis
03/26. Vacationers bring unwanted present home
03/25. More Canadians being diagnosed with hepatitis
03/25. Viral outbreak
03/24. State to fine Dee Creek Dairy $8,000
03/23. E.coli bacteria found in cured sausage
03/23. Thailand battles major outbreak of botulism
03/23. Woman suing restaurant over food poisoning in August
03/23. Investigation focuses on food served to deputies

Current USDA/FDA News Summary
To view the articles, click here to enter outbreak news

-Food Defense Acronyms, Abbreviations and Definitions
-Letter Regarding Benzene Levels in Soft Drinks
-Ike Scenario 04D-06: Clarification of the Appeal Process
-Consumer Guidelines for the Safe Cooking of Poultry Products
-Guidance for Industry: Recommendations for Submission of Chemical and Technological Data for Direct Food Additive
-USDA To Dispatch Technical Team To Japan
-USDA/Alabama BSE Epidemiological Update
-Reaching At-Risk Audiences and Today's Other Food Safety Challenges: 2006 Food Safety Education Conference
-New IKE scenario addresses NR appeal process
-FDA Prohibits Use of Antiviral Drugs in Poultry to Help Keep Drugs Effective for Humans
-Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food
-FSIS reissues directive clarifying use of photographs
-SECOND USDA CONFIRMATORY TEST RESULTS POSITIVE FOR BSE
-GIPSA Verifies Performance of Test Kit to Detect Aflatoxin in Corn
-Confidentiality arrangement between the FDA and French Health Products Safety Agency
-FDA Joins Investigation of Latest BSE Case
-David W. Boyer Appointed New Head of FDA's Office of Legislation
-Presentations from Meeting on Advances in Post-Harvest Reduction of Salmonella in Poultry
-EIAO Assessment of Compliance with the Listeria monocytogenes (LM) Regulation
-Verification Procedures for Consumer Safety Inspectors for the Listeria monocytogenes Regulation
-BSE; Minimal-risk regions and importation of commodities
-National Advisory Committee on Microbiological Criteria for Foods
-Ante-mortem inspection of horses; Correction

Crops 'widely contaminated' by genetically modified DNA

23 February 2004
NewScientist.com news service
Fred Pearce
Source of Article: http://www.newscientisttech.com/
US scientists are warning of a potentially "serious risk to human health" after the discovery that traditional varieties of major American food crops are widely contaminated by DNA sequences from GM crops. Crops engineered to produce industrial chemicals and drugs - so-called "pharm" crops - could already be poisoning ostensibly GM-free crops grown for food, warns the study by the Washington-based Union for Concerned Scientists, released on Monday. "If genes find their way from pharm crops to ordinary corn, they or their products could wind up in drug-laced corn flakes," says the report's co-author, UCS microbiologist Margaret Mellon.

In trials, crops have been genetically engineered to manufacture proteins for healing wounds and treating conditions such as cystic fibrosis, cirrhosis of the liver and anaemia; antibodies to fight cancer and vaccines against rabies, cholera and foot-and-mouth disease. Conventional drugs manufacture is subject to stringent controls to prevent them entering the food chain or contaminating the natural environment. But there are currently no such controls to prevent the spread of DNA sequences from pharm crops. The UCS asked two commercial laboratories to test traditional varieties of three crops - maize, soybeans and canola or oil-seed rape - for specific sequences of DNA that have been introduced into GM varieties currently grown on US farms. The sequences studied mostly give resistance to proprietary pesticides. The labs reported that the seeds were "pervasively contaminated with low levels of DNA sequences from GM varieties". Up to 1 per cent of individual seeds, and more than half the batches of seeds, contained one or more of the GM sequences.

Cross-pollination
There is no evidence that the crops tested were unsafe, say the authors. But they fear this may not be true for second-generation GM crops that contain DNA sequences that manufacture drugs and industrial chemicals. "Seed contamination is the back door to the food supply," says Mellon. "The realisation that some seeds may already have been contaminated [by pharm crops] is alarming" and could pose a "serious risk to human health".
Until now concern about GM contamination has focused on cross-pollination in the field. But the authors guess that much of the contamination has arisen from a failure to keep GM and traditional seeds apart during manufacture and distribution.
The tests did not discover any crops contaminated with sequences from pharm or industrial crops because there are no current tests for them. But co-author and plant pathologist Jane Rissler warns: "Until we know otherwise, it is prudent to assume that engineered sequences originating in any crop - including genes from crops engineered to produce drugs, plastics and vaccines - could potentially contaminate the seed supply."


Click here for more information

Japan expresses doubt about U.S. beef during trade talks
by John Gregerson on 3/29/2006 for Meatingplace.com

Japan and the United States began two days of trade talks in Tokyo on Tuesday, during which Agriculture Department officials planned to press for the reopening of Japanese markets to U.S. beef. USDA has said a Tokyo-bound shipment of U.S. veal containing vertebral material was an isolated incident and not indicative of faults in the overall U.S. beef processing, inspection or export systems. But the Japanese government still has doubts.

"The incident has raised a question among Japanese that it is not only the problem of one company but a more serious issue that relates to the U.S. government's functions to check them," Masato Kitera, deputy director general economic affairs at Japan's Foreign Ministry, said at the meeting. The U.S. government must regain trust from Japanese consumers about the system to check if exports meet conditions agreed by the two governments to ensure the safety of U.S. beef, Kitera added. "Otherwise, U.S. beef will not be accepted by Japanese consumers even if the Japanese government allows imports to restart," he said. "We absolutely believe U.S. beef is safe," Charles Lambert, acting undersecretary for marketing with the Agriculture Department, said at the beginning of talks.

Genencor International Launches Revolutionary Enzyme Technology for Prion Decontamination
- Prionzyme(TM) proteases are now available that substantially eliminates causative agents of mad cow disease and vCJD from surf
By: PR Newswire
Mar. 27, 2006 08:00 AM
Source of Article: http://www.sys-con.com/read/198862.htm
PALO ALTO, Calif., March 27 /PRNewswire/ -- Genencor International, Inc. announced today a European Notified Body has assessed and certified the first enzyme technology designed specifically as a prion disinfectant for medical devices. Prions, the causative agents of Bovine Spongiform Encephalopathy (BSE) and its human form, variant Creutzfeldt-Jakob Disease (vCJD), have been a concern in countries like the United Kingdom in recent years due to a lack of technology to reduce the risk from the protein-based particles on medical instruments. Developed jointly with the United Kingdom's Health Protection Agency (HPA) and independently certified for use by a European Community Notified Body, Prionzyme(TM) carries the CE mark (Conformite Europeenne). The product can be used to disinfect medical instruments utilized in invasive surgeries, such as procedures related to the central nervous system, eyes and tonsils, where prions have been shown to accumulate in the body. Genencor plans to further develop its Prionzyme line of products targeted for disinfecting general instruments and for sanitizing equipment for the meat processing industry. Enzymes are proteins that help a chemical reaction take place specifically, quickly and efficiently and offer a number of advantages over traditional harsh and caustic chemical disinfectant methods such as reducing worker safety issues and are environmentally friendly and simple to use. With the launch of Prionzyme, hospitals and sterilization units now have access to a new, highly efficient technology to help them reduce the risk of prion contamination. "Using the tools of biotechnology to address important issues facing the world today, Genencor is very pleased to commercialize the first enzyme technology to target this unconventional, infectious agent," said Thomas Pekich, president of Genencor. "Our partnership with the HPA combined with the protease technology expertise we've built over the past two decades has been key to addressing this difficult problem." The use of Genencor's Prionzyme for medical instruments combines the proprietary enzyme with temperature and pH conditions. The product is added as the first step in a presoak process with stainless steel instruments. "This technology will be easily adaptable to current procedures and equipment already in place in hospitals and clinics," said John Gell, vice president, Industrial Specialties for Genencor. "Prionzyme also offers a number of benefits including minimizing worker safety issues by reducing exposure to harsh chemicals; lessening the environmental impact as enzymes biodegrade in disinfectant solution versus concern about disposal of caustic chemicals and providing material compatibility where proteases have been used in conjunction with stainless steel and other components for decades. We are now identifying marketing partners to bring the technology to the medical industry quickly and effectively." Prionzyme M, the first enzyme from the new line of products, carries the CE mark indicating that the protease conforms with the essential requirements established by the European Medical Device Directive 93/42/EEC. Genencor plans for its additional Prionzyme products to also carry the CE designation. Genencor also recently received the ISO 13485:2003 registration at its Cedar Rapids, Iowa production site, where the Prionzyme products are manufactured. Following an extensive audit of the site's quality systems, Lloyd's Register Quality Assurance, a leading International Standards Organization (ISO) registrar and European Community Notified Body, awarded the ISO 13485 certificate of registration. For more information about Prionzyme enzymes, contact Genencor at +1-800-847-5311 (USA only) or +1-800-256-5200.

National Salmonella contamination rising
March 22, 2006
Scripps Howard News Service
Lance Gay
While industry and government efforts are showing progress in battling contamination by other pathogens, U.S. Department of Agriculture statistics indicate there has been a steady increase in Salmonella contamination in poultry over the last five years.
The latest data on poultry contamination compiled by the USDA's Food Safety and Inspection Service shows that about 16 percent of poultry tested positive for Salmonella last year - an 80 percent increase since 2000, when 9 percent of poultry tested positive. The highest rates of contamination were found in ground turkey and broiler chickens.
The Centers for Disease Control estimates that 1.4 million people get sick from Salmonella in the United States each year, with about 400 deaths. But epidemiologists are increasingly concerned about the spread of strains of some drug-resistant Salmonella in animals.
Consumer groups say the increasing cases of Salmonella
contamination show the need for Congress to tighten food inspection
laws to give the USDA greater authority to shut down plants that
aren't taking adequate measures to control the spread of pathogens
Caroline Smith DeWaal, director of food safety at the Center for Science in the Public Interest in Washington, was cited as saying the authority of government inspectors to deal with Salmonella contamination in meat was undercut by a 2001 court decision in a case involving Supreme Beef Processors, which declared Salmonella was a naturally occurring pathogen in poultry, and not "an adulterant" or material added to raw meat that is subject to USDA regulation. Other food pathogens like Listeria and dangerous strains of E. coli are regarded as adulterants.
FSIS Director Richard Raymond was cited as saying the agency plans to concentrate federal food inspectors at plants with poor Salmonella performance records, and is changing rules to provide the results of government-run pathogen tests more quickly to plant authorities so they can take immediate corrective steps.

Restaurant sued in E. coli cases
March 30, 2006
Calgary Sun
Kevin Martin
A lawsuit filed on behalf of Kyle and Megan Westlake-McCoy, was cited as saying the siblings contracted E. coli food poisoning after eating at My Donair in Westbrook Mall and should be awarded up to $600,000 for the injuries they suffered.
The story says that their statement of claim, a copy of which was obtained yesterday by the Sun, said the pair purchased donair sandwiches at the shop on Sept. 12, 2004, adding, "The ... injuries suffered by the plaintiffs were a direct result of the recklessness and negligence of the defendants."
The lawsuit names the restaurant, its owner, and the companies which supplied the meat, Centennial 2000 Inc., Centennial 99 Corp., and Centennial 89 Corp., as defendants.
Statements of defence disputing the unproven allegations of recklessness and negligence have not yet been filed.

Bacterial illness linked to raw milk infecting more people
March 30, 2006
Yakima Herald-Republic (WA)
Jessica Wambach
http://www.yakima-herald.com/page/dis/325960873607897
Since the first of the year, the Yakima Health District has, according to this story, seen a spike in the number of cases of a bacterial infection that causes stomach sickness.
Marianne Patnode, Communicable Disease Services coordinator at the health district, was cited as saying that many of the 41 cases of campylobacteriosis so far this year might be tied to the consumption of unpasteurized milk and related cheese products.
The story notes that by this time last year, only 21 people had reported having the bacterial illness characterized by diarrhea, cramping, abdominal pain and fever, and that while unpasteurized milk products are one potential source of campylobacter infections, consuming and handling raw or undercooked poultry or drinking contaminated water are other common causes.
Patnode was further cited as saying that reported cases have involved people of all ages and races from across the county, but most of those associated with unpasteurized milk products have been in the lower Yakima Valley.

Hepatitis diagnosed in fourth student
March 30, 2006
Lexington Herald-Leader (KY)
Barbara Isaacs
http://www.kentucky.com/mld/kentucky/14219532.htm
Health department officials were cited as reporting yesterday that a fourth kindergarten student at Lexington's Mary Todd Elementary has been diagnosed with hepatitis A.
Earlier this week, a child in Early Start at Yates Elementary also was diagnosed with the disease. That child was in a class of 15 children, ages 3 to 4.
Yesterday's new diagnosis at Mary Todd means that 10 cases of hepatitis A have been reported in Fayette County since early February -- three adults and seven children.
Health department epidemiologists are investigating the illnesses, but aren't yet sure how widespread the problem might be.
Seven of the sick people -- three adults and four children -- are relatives. A child from that family spread the disease to kindergarten classmates at Mary Todd Elementary.
The rash of illnesses is considered an outbreak because there are many more cases of hepatitis A than are normally expected. In 2005, two cases were reported in Fayette County.

Mushrooms suspected as 5 in family fall ill
March 29, 2006
Sacramento Bee (CA)
Deb Kollars
http://www.sacbee.com/content/news/story/14236508p-15057487c.html Sacramento County public health officials were cited as saying that five family members became ill this week - three to the point of liver failure - with symptoms that suggest mushroom poisoning.
Sacramento County Health Officer Dr. Glennah Trochet was cited as saying the family believes that mushrooms they ate during a Sunday meal might have caused the illness, but they do not speak English, which has caused confusion about whether the mushrooms came from a retail establishment or not.
Trochet said the family members live in Sacramento County, but she did not make public their names or ethnicity, or the hospitals where they were treated.
Remnants of the cooked mushrooms that the family ate were tested Wednesday. Preliminary results indicate they carried the toxins present in the Amanita mushroom, which is wild, poisonous and also known as the "death-cap" mushroom.

Rochester scientists develop fast-working biosensor
March 23, 2006
Science Letter Via Thomson Dialog NewsEdge
University of Rochester Medical Center scientists have demonstrated a new technology that accurately and rapidly detects the meat-spoiling and sometimes dangerous E. coli bacteria.
The unique technology uses a protein from the suspect bacteria as part of the sensing system that also includes a silicon chip and a digital camera.
The journal, Biosensors and Bioelectronics published an article on the technology in a recent issue. Benjamin Miller, PhD, an associate professor of dermatology at the Medical Center, is the lead author of the article.
"We've developed a very inexpensive technology that can detect an infectious agent," said Miller, who is part of the university's Center for Future Health "It's clearly faster and cheaper than any competing techlogy. This is another step on the way to point-of-care diagnostics."
The technology potentially could detect any biological entity, Miller said. A physician someday, for example, could use the technology in his office to confirm a streptococcal infection in a patient with a sore throat.
The Rochester research team calls the technology "arrayed imaging reflectometry." The system utilizes a silicon chip that is made so that laser light reflected off the chip is invisible unless the target bacteria are present.
The target described in the Biosensors and Bioelectronics article is the bacteria Escherichia coli.
A protein from the bacteria, Translocated Intimin Receptor or Tir, is placed on the chip. The Tir can be seen as a "molecular harpoon," Miller said. The E. coli sends out the harpoon into a cell. Once it is in the cell, the Tir then binds with an E. coli protein called Intimin. A similar process occurs between the Tir placed on the chip and any E. coli in the sample being tested. The binding of the probe and the bacteria alters the surface of the chip. A digital camera image of the chip captures the changes for analysis and confirmation of detection.
Traditional methods of detection of bacteria can take days. "This takes as much time as it takes for a snapshot," Miller said.
The scientists currently are defining the sensitivity levels of the technology, previously called reflective interferometry, and extending the system to other biological targets.
This article was prepared by Science Letter editors from staff and other reports.

Canada Adopts Method to Extract Noroviruses from Oysters
By Jim Core
March 24, 2006
Several agencies responsible for public health oversight in Canada recently adopted a technique based on research by Agricultural Research Service (ARS) scientists to extract and test noroviruses in oysters. Noroviruses, which cause approximately 23 million illnesses each year, are the leading cause of nonbacterial acute gastroenteritis outbreaks. They are associated with outbreaks in schools and nursing homes, on cruise ships, and with the consumption of contaminated water and food. The extraction method is based on a procedure published in 2001 by microbiologist David H. Kingsley and lead scientist Gary P. Richards at the ARS Microbial Safety of Aquaculture Products Center of Excellence at Delaware State University in Dover.

Health Canada recently published the procedure as a laboratory method in its ¡°Compendium of Analytical Methods,¡± which provides a ready reference on techniques used by Health Canada, Agriculture and Agri-Food Canada, and the Canadian Food Inspection Agency.These agencies evaluated the method for effectiveness, as did the U.S. Food and Drug Administration, the British Columbia Centre for Disease Control, state and provincial universities, and other agencies. The publication is available online at:
http://www.hc-sc.gc.ca/fn-an/res-rech/analy-meth/microbio/volume5/index_e.html

The method effectively separates and purifies norovirus genetic materials from within oyster tissues. Oysters, clams and mussels have caused numerous outbreaks of norovirus illness. Symptoms of the illness include potentially severe diarrhea, vomiting or both that develop usually within a day after consuming contaminated food or drink. Symptoms typically last for about 48 hours. In 2002, the ARS researchers published an article on the successful use of the method to detect both hepatitis A virus and norovirus in Asian clams implicated in an outbreak of norovirus illness in New York State. Canadian scientists first contacted Richards in 2004 about a suspected outbreak of oyster-associated norovirus illness in British Columbia, which led to an evaluation of the ARS method. ARS is the U.S. Department of Agriculture¡¯s chief scientific research agency.

Test System for Prediction and Prevention of the Formation of Mycotoxins
Source of Article: http://pharmalicensing.com/licensing/displicopp/4125
A German research institute has developed a test system allowing detection of the expression of certain mycotoxin genes in situ, before the production of mycotoxins can be detected analytically.

Full description
Mycotoxins such as aflatoxin, trichothecene, ochratoxin, zearalenon and patulin are fungal toxins, which are heat-stable compounds and are therefore generally not destroyed during food processing. Mycotoxins can lead to acute or chronic poisoning. The FAO estimates that worldwide up to 25% of food is contaminated with mycotoxins. The formation of mycotoxins depends strongly on the growth conditions, respectively the external stress factors, to which a fungus is subjected, in particular, factors such as the availability of nutrients, water activity, pH and temperature. It is important to control these factors along the food chain to maintain the formation of mycotoxin at the lowest possible level.

Analytical methods for the detection of mycotoxins already exist and levels of mycotoxins can readily be measured very accurately in food. The disadvantage of these methods, however, is the fact that the analysis only returns a positive result once the toxins have been formed Important for a meaningful monitoring of the production of mycotoxins would be the measurement of the rate of expression of mycotoxin genes, because these genes are sometimes expressed over 48 hours prior to the production of mycotoxins and thus would allow an early warning.

Scientists of the Federal Research Institute for Nutrition and Food have developed for this purpose a test system that allows the detection of the expression of certain mycotoxin genes in situ, before the production of mycotoxins can be detected analytically. This test system comprises a microarray (DNA Chip) that contains oligonucleotides that are homologous to genes of several fungal species responsible for the biosynthesis of mycotoxins. The DNA chip allows simple hybridisation assays to be carried out to establish the rate of expression of mycotoxins

With the help of such an assay, one can obtain a prediction regarding the formation of mycotoxins, which can then be used to take preventive action. In addition, through the patterns of expression that are observed, the assay provides information regarding the factors under which a particular fungus produces mycotoxins, respectively the factors that lead to an increase in toxin production. Applying modelling to the data produced in this manner allows for example for risk profiles to be established, which are useful inputs for the formulation of a prevention strategy for the food production process.

Innovative aspects: The new system allows the detection of the expression of mycotoxin genes before the mycotoxins have actually been formed. Thus the contamination of food can be predicted and prevented.

Main advantages: - Microarray for the analysis of the expressed mycotoxin genes using DNA hybridisation - Predicting mycotoxin production in food processing - Simplified monitoring of mycotoxin production in the food chain - Gene expression models as a function of external factors and corresponding risk profiles - Prevention strategy to achieve mycotoxin-free food production - Flexible and adaptable system, which currently covers all important mycotoxins relevant to food

Exposing children to allergens
03/28/2006
Source of Article: http://www.wndu.com/moms/032006/moms_48863.php
Scientists are trying to out-smart allergies by inundating children with them.
According to USA Today, the United States will finance a British study, which will expose infants to peanuts.
Researchers will look at whether high doses at a young age will actually teach the immune system that the nuts are not a threat.
Conventional medical wisdom recommends keeping peanuts from children until they are three, to lessen the chance of life-threatening allergies.
However, new research into that theory, and other allergies, shows it may be more effective to introduce them earlier. Researchers say parents should NOT test the theory at home and give infants large doses of peanuts. Researchers also say the same thinking may also work for other allergens such as pet dander.

Benzene levels in soft drinks are safe, says FDA
By Chris Mercer
Source of Article: http://www.foodproductiondaily.com/news/ng.asp?n=66727-fda-benzene-soft-drinks
29/03/2006 - Levels of benzene found in soft drinks so far are not a safety risk for consumers, says the US food safety watchdog, attempting to calm public concern.

The US Food and Drug Administration (FDA) made the statement in a letter to the Environmental Working Group (EWG), a campaigns body.
The EWG had asked authorities to warn consumers, after the FDA revealed to BeverageDaily.com in February it had found some drinks containing benzene above the legal limit for drinking water in the US. The FDA has tried to reassure consumers by emphasising there was no immediate risk to consumers' health from benzene levels found so far in drinks. Most drinks were well inside the limit for water, it said.
Still, the agency added it would not release results until it had done more testing.
Benzene is listed as a carcinogen by health authorities.
Both the FDA and America's soft drinks association have known for 15 years that benzene could form in soft drinks containing a combination of sodium benzoate and ascorbic acid (vitamin C).

No public announcement was made and the FDA agreed to let the soft drinks industry ¡°get the word out and reformulate¡±, found a BeverageDaily.com investigation earlier this year. The US safety watchdog was re-alerted to benzene in soft drinks by private laboratory testing in New York last autumn, paid for by a US lawyer and an industry whistleblower. The news indicated a communication breakdown. Both FDA chemist Greg Diachenko and American Beverage Association spokesperson Kevin Keane, subsequently told BeverageDaily.com it was possible that some firms had not got the message about sodium benzoate and ascorbic acid in drinks.

More than 1,500 soft drinks containing both sodium benzoate and ascorbic acid or citric acid have been launched across Europe, North America and Latin America since 2002. The FDA said it was now working with the relevant companies to reduce benzene levels where necessary, in what appears a similar approach to that taken 15 years ago. Industry testing back then showed that benzene levels could rise several times when drinks containing sodium benzoate and ascorbic acid were exposed to heat and light. Adjusting the levels of sodium benzoate and ascorbic acid, as well as adding sugar and the additive EDTA, were found to help reduce benzene formation.

The renewed investigation has, however, sparked considerable debate over what level of benzene is acceptable in soft drinks. There is no specific limit for soft drinks, and water limits range from 10 parts per billion (World Health Organisation), 5ppb in the US and one part per billion in the EU.

Glen Lawrence, a scientist who helped the FDA understand the problem with sodium benzoate and ascorbic acid in 1990, told BeverageDaily.com soft drinks companies should change their formulas.

¡°There is no good reason to add ascorbic acid (vitamin C) to soft drinks, and those that may have ascorbic acid naturally in them (juices) should not use sodium benzoate as a preservative. So it is really very easy to avoid the problem.¡±