7/09
2004

ISSUE:
125

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Current Good Manufacturing Practice Regulations; Public Meetings

Guidelines for food allergy testing

July 7, 2004
Johns Hopkins Medical Institutions
A blood test that measures food-specific allergy antibodies can be used to help pediatric allergists with the difficult decision of when to reintroduce a food that a child has been allergic to, say researchers at the Johns Hopkins Children's Center.
In their report, published in the July issue of The Journal of Allergy and Clinical Immunology, the researchers provide guidelines for using these antibody levels to determine which children should be offered an additional allergy test, known as an oral food challenge, in which the child eats small amounts of the food allergen to establish whether or not a food allergy really exists.
Based on results of their investigation into how well IgE antibody levels could predict children's reactions on the oral food challenge test, the Hopkins team specifically recommends that challenge tests for milk, egg, and peanut be performed on children with at least a 50-50 chance of "passing."
This 50-50 challenge pass rate was most clear for milk, egg, and peanut and was associated with low levels (less than 2.0 kilounits of antibody per liter of blood) of food-specific IgE, the antibodies produced by the immune system that can cause allergic reaction. These antibodies can be measured using a test that is available in most commercial labs.
"These findings make it clear that doing a blood test to measure IgE levels can accurately predict how a patient will fare during a food challenge, and we recommend its routine use in clinical practice to screen children with suspected allergies before a food challenge is performed," says Robert Wood, M.D., a pediatric allergist at the Johns Hopkins Children's Center and the study's senior author.
"By using our data as a guideline, physicians can better determine the appropriate time to try to reintroduce foods into an allergic child's diet," Wood adds. "An historical lack of such guidelines has led to considerable indecision in the appropriate timing of food challenges."
Patients with IgE levels of 2.0 kilounits or less ?who fall under the new Hopkins guidelines ?are more likely to pass a food challenge because their low IgE levels could indicate a developed tolerance to the allergen or a previous allergy misdiagnosis. "Without a definitive allergy diagnosis from a food challenge, children with low IgE levels who may no longer be allergic, or who were misdiagnosed with a food allergy, may be unnecessarily avoiding foods like milk, eggs, and peanuts which have significant nutritional benefits," Wood says.
On the flip side, when the expected pass rate for a food challenge is less than 50 percent, or for IgE levels of more than 2.0 kilounits, he says it's very likely that the patient has a legitimate food allergy and therefore does not need his or her allergy confirmed through a food challenge, which could cause a significant allergic reaction.
In the study, researchers reviewed the charts of 391 children who underwent 604 oral food challenges to milk, egg, peanut, soy, and wheat at the Children's Center from 1999-2001. They discovered that levels of IgE allergy antibodies against milk, egg, and peanut were significantly higher in those patients who had an allergic reaction and "failed" a food challenge compared to those who "passed." Data for soy and wheat were less clear.
Although food challenges have long been the "gold standard" for diagnosing food allergies, Wood says physicians do not have any clear, clinical guidelines to help them determine when a food challenge should be considered, meaning it's possible some children who could benefit from the test may be overlooked.
During a food challenge, patients are fed increasing doses of the suspected allergen while being monitored by a physician for symptoms of an allergic reaction, including hives, coughing, difficulty breathing and vomiting. Because of the possibility of a severe allergic reaction, oral food challenges must take place in a clinical setting while under a physician's supervision.
Experts say food allergies are extremely common, affecting up to 8 percent of children and 2 percent of adolescents and adults. In young children, the foods most likely to cause allergies are cow's milk, eggs, wheat and peanuts. In older children and adults, peanut and seafood allergies are most common. Other foods that commonly cause allergic reactions include soy products and tree nuts, such as almonds, pecans, and Brazil nuts

INDUSTRY SURVEY: Announcing inconclusive BSE tests fuels unwarranted fear
by Ann Bagel on 7/6/04 for Meatingplace.com
Source of Article: www.meatingplace.com
The U.S. Department of Agriculture has immediately reported all inconclusive test results from its enhanced BSE surveillance program, but a large majority of respondents to a recent Meatingplace.com survey disagree with that decision.Almost 70 percent of respondents said USDA's Animal and Plant Health Inspection Service should not disclose inconclusive BSE test results prior to confirmation because it "only fuels unwarranted speculation and fear."By the same token, 63 percent of respondents said they believed releasing inconclusive tests will weaken public confidence in the safety of the U.S. beef supply, saying "every media mention of BSE or mad cow disease adds to the public's confusion on BSE."The Meatingplace.com survey was designed to measure industry reaction to the announcement by APHIS of two inconclusive BSE tests in less than a week, which led to a flurry of speculation and volatile market reaction.Those that disagreed with the decision to report inconclusive results generally felt USDA was "crying wolf" and inciting negative reaction before positive results were confirmed. Many cited inaccurate or misleading reports by the media as well as confusion and apathy among the general public."Probably less than 5 percent of the general public even understands BSE," wrote one respondent. "Providing these results will only put 'ignorant fear' in the minds of consumers."In an e-mail sent to Meatingplace.com editors, William Sperber, a senior corporate microbiologist at Cargill, wrote that the first two inconclusive announcements "seemed a lot like the Department of Homeland Security changing its color code for terror alert levels. I suspect that the public will learn to ignore both of these warning systems, much as it already ignores the warning statements on cigarette packages and liquor bottles."There was some support among respondents for USDA's decision to disclose inconclusive results. Many mentioned the possibility of rumors or false information leaking through other sources, as well as questions about public confidence in the agency.

"The main issue is not so much food safety but credibility of the USDA," one respondent wrote. "Transparency will hopefully not only build confidence from the consumer but also help the department wean itself from the corrupt practices that run it today."Results are based on a sample of 414 Meatingplace.com members who responded to a July 1 invitation on this site to participate in a four-question survey, including written comments, which was fielded via Zoomerang.com.To view the aggregate survey results, click here.

Uof M receives $15 million for food safety studies
Source of Article: http://twincities.bizjournals.com/

The University of Minnesota on Tuesday morning officially received a $15 million grant to study ways to prevent terrorists from threatening the country's food supply.Homeland Security Secretary Tom Ridge and Agriculture Secretary Ann Veneman participated in the ceremony awarding the money. The grant, first announced in April, will fund the U's Center for Food Protection and Defense for three years. The university will study foreign animal diseases and food security. The research effort will be headed by Dr. Francis Busta of the Department of Food Science and Nutrition and will be performed by the University Center for Post-Harvest Food Protection and Defense, a national consortium of academic, private sector and government partners. The consortium includes major food companies, other universities and private consultants. Among local food companies participating are: General Mills Inc. in Golden Valley; Cargill Inc. (Minnnetonka); Maplewood-based 3M Co.; and Hormel Foods Corp. in Austin, Minn. Texas A&M University and the University of Southern California received similar grants.

E. coli O157, day care center - USA (NY City) (02)
July 2, 2004
ProMED-mail post
http://www.promedmail.org
Source: News12 Long Island [edited]
The center hired a private team to run tests in order to determine where the bacterium came from. In addition, New York City Department of Health inspectors say the center will be thoroughly sterilized before kids can step foot back inside. Experts say there is really no way to protect against E. coli but add that proper hygiene can help. Health officials say parents should be on the lookout for symptoms such as abdominal pain, diarrhea that becomes bloody, fever and irritability. They say the infection is caused by poor hand washing, handling of diapers and unsafe food preparation.
If the cleaning and inspection process goes smoothly, the center may open on Wed 7 Jul 2004
.

Bacteria detection in meat with new sensor technology

Source of Article: http://www.ift.org/news_bin/news/news_home.shtml

7/06/2004-The Danish biotech company Atonomics announced that it will market its new biosensor technology for bacteria detection in meat. The core of Atonomics' technology is the use of Surface Acoustic Waves (SAW). A SAW filter consists of inter-digital electrodes called "inter-digital-transducers" (IDTs) on a piezo-substrate. In the sensors, there is a resonator covered by a biochemical filter designed to slip through the molecule that is to be detected. Several academic scientists have used Atonomics' technology and proved that it has a high level of sensitivity. For more information, see http://www.foodoresund.com/composite-373.htm.

STATEMENT OF DR. BARBARA J. MASTERS Acting Administrator, USDA Food Safety And Inspection Service
OIG Audit of the Listeria Outbreak in the Northeast U.S.

"The Food Safety and Inspection Service (FSIS) welcomes the comments of the Office of Inspector General (OIG) regarding FSIS' response to the outbreak of Listeria monocytogenes (LM) in the Northeast U.S. almost two years ago (September, 2002). More than 50 FSIS investigators and scientists, working with the Centers for Disease Control and Prevention, investigated more than 10 processing facilities and FSIS analyzed more than 1,000 product and environmental samples to find the cause of the outbreak. The strain of the pathogen defined by CDC was eventually located at a Pilgrim's Pride Corporation facility in Pennsylvania and at Jack Lambersky Poultry Products, Inc. in New Jersey. None of the other 2002 LM recalls reviewed by OIG were associated with the outbreak strain.

"This unprecedented epidemiological investigation conducted by CDC and FSIS can be considered a model for inter-agency cooperation. As a result, this very difficult case was resolved efficiently and in as rapid a manner as possible.

"To address issues identified by the FSIS/CDC investigation at Jack Lambersky Poultry Products, FSIS took immediate and positive corrective action. As a result, FSIS issued a Notice of Intended Enforcement (NOIE), and required the company to submit a detailed plan of corrective action. The company reassessed its Sanitation Standard Operating Procedures and HACCP plans, installed a post pasteurization process for its fully cooked ready-to-eat items and is conducting an ongoing Listeria sampling program for environmental and finished product.

"FSIS has focused extensively during the past two years on strengthening supervisory oversight of in-plant inspection personnel. The In-plant Performance System (IPPS) is in place and circuit supervisors have clear standards and expectations for discussion with in-plant inspection personnel during their on-site visits.

"The Consumer Safety Officers (CSIs) currently assigned at Jack Lambersky have attended the innovative Food Safety Regulatory Essentials (FSRE) training. In addition, all CSIs, including relief inspectors within the Philadelphia District, have been, or are scheduled to attend FSRE training. FSRE training stresses the understanding of HACCP concepts along with production and handling of ready-to-eat (RTE) fully cooked product.

"Following the development and publication of a risk assessment for LM in ready-to-eat meat and poultry products, FSIS published a rule in June 2003 to further drive down the rate of LM. The rule requires all establishments that produce RTE products that are exposed to the environment after cooking to develop written programs to control LM and to verify the effectiveness of those programs through testing. The rule also encourages plants to install new technologies that eliminate or suppress the growth of LM. Establishments must share testing data and plant generated information relevant to their controls with FSIS. Plants that produce high and medium risk products and rely on sanitation procedures alone to control LM receive the most intense Agency regulatory scrutiny.

"A recently completed survey of RTE establishments carried out by FSIS Inspectors-In-Charge revealed that establishments have responded to the rule appropriately and have strengthened and intensified their programs to control LM. Almost every establishment is testing food contact surfaces for Listeria, although plants using a process like steam pasteurization that kills LM inside a package would not be expected to test product contact surfaces, since those products would not be exposed to the environment after cooking. The percentage of plants using interventions that suppress the growth of LM has grown dramatically since the rule went into effect, as have the number of plants that are testing the processing environment and full-cooked products for Listeria.

"The new Listeria rule challenged industry to do more to eliminate LM. The survey indicates that testing has been greatly expanded and the use of new technologies for eliminating this pathogen is becoming widespread. The survey results help explain why we are finding fewer positive samples of Listeria monocytogenes in our regulatory testing program.

"Intensive Agency regulatory efforts carried out prior to the publication of Listeria rule also had a significant positive impact on minimizing food contamination. From 2002 to 2003, the number of recalls due to LM dropped from 40 to 14 and the amount of product recalled due to LM fell from 32.5 million pounds to 55,200 pounds.

"In addition, FSIS has taken action to improve the effectiveness of recalls to ensure to the greatest extent possible and that potentially contaminated products are removed from commerce and consumers receive information more quickly. FSIS has developed and issued revised Directive 8080.1, "Recall of Meat and Poultry Products." This directive will enhance the instructions and guidance to agency personnel responsible for verifying the effectiveness of a recall. To improve speed and efficiency, the revised directive enables the collection of product distribution information at the plant to begin prior to microbiological testing results becoming final. The Agency has also increased the number of effectiveness checks it carries out during Class I recalls, those posing the greatest potential adverse health consequences, and in cases where products have been distributed to at-risk populations. The revised directive includes timeframes for reporting verification activities within FSIS and includes provisions for locating products at point of sale and ensuring the proper disposition of recalled products. We are continuing to review this issue to determine to determine appropriate ways to further strengthen the recall process.

"FSIS, through its Office of Program Evaluation, Enforcement and Review (PEER) will be continually monitoring progress in these areas to ensure that these new initiatives remain effective over time.

"FSIS looks forward to working with OIG in the future as FSIS develops cost-effective and science-based policies that will improve the safety and wholesomeness of meat and poultry products enjoyed by American consumers."




New Product For Optimizing Listeria Identification

It is now well established that the genus Listeria consists of the following 6 species: L. monocytogenes, L. innocua, L. seeligeri, L. welshimeri, L ivanovii and L. grayi. L. innocua was originally classified as L. monocytogenes until it was determined that that this species in fact contained 2 distinct groups based on their ability to produce a haemolytic reaction on sheep blood agar. Subsequently L. monocytogenes were defined as the haemolytic virulent strain while the new species L. innocua were the non haemolytic avirulent strains. The name innocua was derived from the Latin word for harmless. L. welshimeri and L. seeligeri are well established as non haemolytic avirulent species, while L. ivanovii was formerly classified as L. monocytogenes serovar 5 until it was reclassified in 1984.

In the 1980's, the incidence of cases of listeriosis increased significantly. This increase was accompanied by a number of foodborne outbreaks caused by L. monocytogenes. Listeria spp. are ubiquitous in the environment, L. monocytogenes being the major human pathogen while L. ivanovii is rarely documented as causing human illness. It is therefore important that Listeria spp. are correctly identified.

Currently all standard identification methods rely on the fermentation of sugars and haemolytic reactions. Microbiology International offers a simple yet comprehensive biochemical identification system for the identification of all species of Listeria. The creation of this system began with the development of a well defined product specification. The key elements of this specification were: perform the identification directly from selective media, confirm the isolate as Listeria spp., clear differentiation of all 6 species of Listeria, substrates based on conventional methods, eliminate the need for separate haemolysis or CAMP test, substrates conform to international standards, no assembly required, easy to set up and inoculate, clear interpretation of substrate reactions, results available within 18 - 24 hours from a single colony, and supported by a comprehensive computer based identification package.

All substrates were formulated to provide identical performance to established conventional substrate formulations in a convenient microwell strip format. The microwell haemolysin test, which is critical to the differentiation of L. innocua and L. monocytogenes, was based on the methods of Dominguez Rodriguez but modified to provide long term stability of the reagent. The final test panels were evaluated using 105 strains of Listeria spp obtained from a wide range of food sources. The identification of these isolates was performed using the Microgen¢â Listeria-ID and compared to the identification achieved using 2 alternative identification systems.

All final identifications using the Microgen¢â Listeria-ID were confirmed using the Microgen¢â Identification System Software. The results of this investigation indicated that all 105 isolates examined were correctly identified by the Microgen¢â Listeria-ID as a stand alone system (without the need for additional tests).

Microgen¢â Listeria-ID is available in a package of 20 tests including suspending solution. No additional reagents are needed. It is currently undergoing AOAC-RI evaluation and is expected to be approved by the end of August. For further information or to see if you qualify for a free product sample, please contact Gina M. Dunn at Microbiology International 800-396-4276 or visit http://www.800ezmicro.com/

Microbiology International
Frederick, MD
http://www.800ezmicro.com
1-800EZMICRO (396-4276)

FDA to hold meetings on current state of GMPs
Source of Article: http://www.ift.org/news_bin/news/news_home.shtml
7/06/2004-The Food and Drug Administration (FDA) announced three public meetings to solicit comments, data, and scientific information about the current state of quality management techniques, quality systems approaches, and voluntary industry standards concerning current good manufacturing practices (CGMPs) and other controls used by food manufacturers and processors to prevent, reduce, control, or eliminate food borne hazards that can occur during food production or processing. The meetings are intended to elicit information about FDA's CGMP in manufacturing, packing, or holding human food regulations. For more information, see http://www.fda.gov/OHRMS/DOCKETS/98fr/04-15197.htm.

Current USDA/FDA NEWS
FSIS Directive: Detention and Seizure
FSIS Directive: Experimental and Sample Products Policy
Current Good Manufacturing Practice Regulations; Public Meetings
Statement By Deputy Administrator Dr. John Clifford For APHIS
Statement By Dr. Peter Fernandez Of APHIS For The U.S. BSE Technical Working Group
Statement By Deputy Administrator Dr. John Clifford For The Animal And Plant Health
BARBARA J. MASTERS USDA-FSIS: OIG Audit of the Listeria Outbreak in the Northeast U.S.
Compliance Policy Guide Regarding Prior Notice of Imported Food Under the Public Health
¡±Make Sure To Chill-Out Before You Grill Out"
Statement By Deputy Administrator Dr. John Clifford For The Animal Plant Health Inspection
Conference Grants to Support State Food Safety Task Force Meetings

Current Outbreaks
07/07. E. coli O157, day care center - USA (NY City)
07/07. Bacteria kills Johnson City child
07/07. E. coli O157, day care center - USA (New York City)
07/06. [UK] Children confirmed with E.coli
07/06. Bug left boy fighting for life
07/06. E. COLI OUTBREAK HITS BRONX DAY-CARE TOTS
07/05. [UK] Nine struck by e.coli
07/05. E. coli ties with other states possible
07/05. 3 Possible E. Coli Cases In Pierce County
07/04. SIR PATRICK: I SAW STARS AFTER BAD DUCK EGG
07/04. Biman Food-Probe report on origin of poisoning today
07/03. Food Poisoning Suspected in 102 Thai Kids
07/03. Food poisoning strikes with a vengeance - Contaminated edible


Current New Methods
07/07. Bacteria detection in meat with new sensor technology
07/07. Bacteria detection in meat with new sensor technology
07/07. Allergen test for new food labels
07/06. FSU scientists develop new tests to detect nut allergens in
07/06. Bad wine might kill germs
07/06. Brazilian Government Approves BAX(R) System as Official Refe
07/05. Neogen's New Lateral Flow Reader, Analyses and Stores Results
07/05. Practical Concerns with Algorithms and Rapid Microbiology Systems
07/02. eMerge Interactive Announces Installation of Second VerifEYE

Current Food Safety Informaiton
07/07. Chemical safety ?Contaminants
07/07. Guidelines for food allergy testing
07/07. BSE technical working group
07/07. Revised compliance for bioterrorism act
07/07. Ridge, Veneman mark launch of food and ag security centers
07/07. [Canada] Meat Hygiene Directives
07/07. [EU] BSE - monitoring results
07/07. Chemical safety
07/07. July issue of FSA News available online
07/07. Scrutinizing of local restaurants questioned: Health ministr
07/07. India-children dead
07/07. FDA has yet to enact mad cow safeguards

07/06. Human error likely caused mad cow scare
07/06. Was it the restaurant that made you sick?
07/06. Prison abattoir hopes to put inmates back to work after shut
07/06. Food rules cancel fundraising event
07/06. Tyson meat workers at Wallula, Wash., plant protest testing
07/06. Food Safety Conference 2004 11-12 October 2004 Gold Coast
07/06. Publication of new hygiene legislation

07/05. Philippines promises cleaner octopus to US
07/05. Delays plague Aylmer meat probe
07/05. [Ireland] Closure orders served on four food businesses last
07/05. [Philippines] Belmonte orders crackdown on expired food
07/05. FDA to hold meetings on current state of GMPs
07/05. EU releases BSE monitoring results
07/05. Meat industry and government agencies need to be transparent
07/05. 07/05. RECALL REVIEWED
07/05. Despite 'limitations,' Japan to continue blanket BSE testing
07/05. NCBA study: Beef buyers, consumers know little about irradia
07/05. INDUSTRY SURVEY: Announcing inconclusive BSE tests fuels unw
07/05. McDonald's debuts beef traceability program

07/04. Japanese restaurants display cattle information for beef men
07/04. AMI Submits Comments on Food Labeling Regulations
07/04. FSIS Issues Two Directives
07/04. Xolair is Being Evaluated in Patients Suffering From Peanut
07/04. Bill calls for nut warnings to be posted at restaurants
07/04. Use of vitamins in cradle linked to allergies
07/04. Labeling rules likely for food allergies by next week
07/04. Guidelines for food allergy testing
07/04. Low health risk from acrylamide in food: expert panel
07/04. FDA to Publish Long-Delayed Mad Cow Rules
07/04. Canada to Unveil Mad Cow Safety Guidelines Friday
07/04. [UK] Watchdog to urge overhaul of BSE checks

07/03. Inconclusive BSE tests spark debate
07/03. Second BSE test negative; expect more inconclusive results
07/03. Stalemate for UK as analysis turns BSE spotlight on France
07/03. British mad cow safeguards criticized
07/03. County hears more on bovine disease
07/03. Food hygiene survey dishes the dirt on British TV chefs
07/03. Some shoppers not scared by food warnings
07/03. U of M To Launch Center For Food Protection And Defense
07/03. Class-action suit filed over Chili's salmonella outbreak
07/03. Hepatitis: A Common Virus
07/03. July is hot month for homemade ice cream
07/03. Escherichia coli O157:H7 Frequently Asked Questions
07/03. Putting additives in food highly regulated by FDA
07/03. UofM receives $15 million for food safety studies
07/03. [China] 82% of the public is most worried about food safety,
07/03. Local food handlers adhere to state law with crash course in
07/03. Safeway fined ?,500 for selling out-of-date food at three s

Current Recall Information

Oxoid Involved in Major Campylobacter Project
Oxoid Limited, one of the world's leading manufacturers of microbiological culture media and diagnostic tests, are pleased to announce their participation in CAMPYCHECK, a shared-cost three year project within the EU Fifth Framework "Quality of Life and Management of Living Resources" programme, entitled "Improved physiological, immunological and molecular tools for the recovery and identification of emerging Campylobacteraceae in the food and water chain" (QLK1 CT 2002 02201).

The CAMPYCHECK project will focus on emerging Campylobacteraceae looking at the development of routine isolation and detection methods which will allow effective screening of samples in outbreak situations. Epidemiological data on the micro-organisms will be generated that will be essential to the instigation of effective control measures for food and water.

A risk assessment model for emerging Campylobacteraceae in food and water will be generated which will be a major benefit to both the food and water industries and public health bodies alike.

The CAMPYCHECK research project's aim is to address the limitations of current isolation and identification methods. It also aims to establish the prevalence of these micro-organisms in patient and animal faeces and the food and water chain in Europe, USA and South Africa.

The Oxoid CAMPYCHECK project team is led by Peter Stephens, R & D Manager. "I am delighted that Oxoid are involved in this important project that aims to develop routine methods for isolation, detection and typing of emerging Campylobacteraceae from food, water, environmental and clinical specimens", says Peter. "As well as proving invaluable in epidemiological studies the new methods will also allow us to look at the survival of these pathogens in the food chain and examine issues that affect pathogenicity and virulence. We also expect that practical strategies for control of the pathogen in the food and the water industry will be developed during the course of the project," concludes Peter.

CAMPYCHECK is co-ordinated by the University of Southampton, UK. The project brings together European, South African and American veterinary, food and biomedical specialists working in academia, research institutions and the food industry.

For Further details of the CAMPYCHECK project and partners please visit www.campycheck.org.