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Journal of Food Safety
2/08
2008
ISSUE:291
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Internet Journal of Food Safety
FDA Unveils New
Policy to Address Listeria Control in Food
February 07, 2008 Source of Article: http://www.meatami.com/
The Food and Drug Administration (FDA) has announced a new draft compliance
policy for control of Listeria monocytogenes (Lm) in ready-to-eat (RTE)
foods that for the first time creates different policies for foods that
support growth of the organism and foods that do not. AMI has long sought
the Food Safety and Inspection Service (FSIS) to adopt a similar science-based
policy which reflects international standards adopted by Europe, Canada
and other nations.
For foods that do not support growth of Lm, FDA will revise its tolerance
level from zero to 100 colony forming units per gram of food (cfu/g).
The ¡°zero tolerance¡± standard for those RTE foods that support the growth
of the pathogen will remain the same.
Three draft documents are published
in today's Federal Register, including a draft Compliance Policy Guide
that provides guidance for FDA staff on the agency¡¯s enforcement policy,
draft Guidance for Industry on Control of Listeria monocytogenes in Refrigerated
or Frozen Ready-to-Eat Foods, and a Notice of a Public Meeting on March
28, 2008 to receive public comments on the proposed changes to the agency¡¯s
policy for Listeria monocytogenes (Lm) in ready-to-eat (RTE) foods that
are under the jurisdiction of FDA.
FDA¡¯s proposed new policy recommends the creation of two categories for
RTE foods: those that support growth of the pathogen and those that do
not.
The draft CPG defines RTE foods that do not support growth of Lm using
the following criteria:
- The pH of the food is less than or equal to 4.4; or
- Is customarily held and consumed in a frozen state; or
- The water activity of the food is less than or equal to 0.92; or
- Is processed using an effective listeristatic control measure (e.g.,
an antimicrobial substance or a combination of factors such as pH, water
activity, and antimicrobial substances).
For the category of foods that
support the growth of Lm during the shelf life, FDA policy does not change
and the agency will consider the food to be adulterated when Lm is present
in the food based upon the analytical method that can detect 1.0 cfu per
25 grams (g) of food (i.e. 0.04 cfu/g). For the category of foods which
have been determined to not support the growth of Lm, FDA may regard the
food as adulterated when Lm is present at or above 100 cfu/g of food.
¡°We welcome the Food and Drug Administration¡¯s new Listeria monocytogenes
draft guidance on Listeria monocytogenes control in food,¡± said Randall
Huffman, Ph.D., vice president of scientific affairs at the American Meat
Institute Foundation (AMIF). ¡°AMI will review and provide comments to
the agency on this important initiative. Our initial review indicates
that FDA¡¯s action appears scientifically sound, will ensure public health
and reflects Listeria control policies in Europe, Canada and other nations
as well as the current thinking within the Codex Alimentarius. Given global
food trade, it is important food safety policies be harmonized in this
way. We hope that FDA and USDA¡¯s Food Safety and Inspection Service (FSIS)
will work toward harmonizing food safety policies in a similar way within
the United States. We urge FSIS to follow FDA¡¯s lead on this policy.¡±
To view these documents, go to http://www.access.gpo.gov
FDA drafts
policy to control listeria
By Tom Johnston on 2/7/2008 for Meatingplace.com
The Food and Drug Administration announced Thursday a draft compliance
policy to control Listeria moncytogenes in ready-to-eat (RTE) foods that
support growth of the organism and those that do not.
The draft describes the characteristics of both and recommends they be
considered as two separate categories. For those that do support listeria
growth, the tolerance level for colony forming units would remain the
same. For those that do not, FDA says it will revise its tolerance level
from zero to 100 colony-forming units per gram of food.
Published in today's Federal Register are three draft documents, including
a draft compliance policy guide for FDA staff, a draft guidance for the
industry on control of listeria in refrigerated or frozen RTE foods and
a notice announcing a public meeting March 28 to hear public comments
on the proposed changes.
The American Meat Institute is urging USDA's Food Safety and Inspection
Service to adopt a similar policy, one that reflects listeria-control
policies in Europe, Canada and other nations.
FDA announces
indictments in melamine case
By
Tom Johnston on 2/8/2008 for Meatingplace.com
FDA announced the indictments of two Chinese companies and a U.S. firm
for importing pet food ingredients laced with melamine.
The action comes nearly a year after a pet food manufacture alerted the
Food and Drug Administration to the death of 14 cats and dogs, and the
eventual depopulation of more than 100,000 chickens and hogs.
Xuzhou Anying Biologic Technology Development Co. (XAC), a Chinese firm
that processes and exports plant proteins to the United States; Mao Linzhun,
a Chinese national who is the owner and manger of XAC; Suzhou Textiles,
Silk, Light Industrial Products, Arts and Crafts I/E Co. (SSC), a Chinese
export broker that exports products from China to the United States; and
Chen Zhen Hao, a Chinese national and president of SSC were charged in
a 26-count indictment returned by a federal grand jury in Kansas City,
Mo.
Also indicted were ChemNutra, a Las Vegas-based corporation that buys
food and food components from China to sell to U.S. companies in the food
industry, and ChemNutra owners Sally Qing Miller and her husband, Stephen
S. Miller, who were charged in a separate but related 27-count indictment.
The indictments charge all seven defendants with delivering adulterated
food that contained melamine, a substance that may render the food harmful
to health, into interstate commerce, among other charges.
The indictments allege that more than 800 tons of purported wheat gluten,
valued at some $850,000, was imported into the United States between Nov.
6, 2006, and Feb. 21, 2007, and that SSC falsely declared to Beijing that
those shipments weren't subject to mandatory inspection prior to export.
Melamine is an industrial chemical that can be used in the manufacture
of plastics, cleaning products, glues, inks and fertilizers. It can be
mixed with wheat gluten to make the product appear to have a higher protein
level. Pet food manufacturers often use wheat gluten as a thickener or
binding agent in certain types of pet food.
It was determined that melamine contaminated chicken flocks and hog herds
across the country by way of farm feed that contained salvage pet food.
On March 15, 2007, a pet food manufacturer alerted FDA to the deaths of
14 cats and dogs, several reported by consumers and several that died
during routine taste trials conducted by the company. The animals were
reported to have developed kidney failure after eating pet food that had
been manufactured with the purported wheat gluten, FDA said.
Families
sue raw milk producer, Organic Pastures, over E. coli outbreak
Posted
on February 8, 2008 by E. coli Lawyer
Source of Article: http://www.marlerblog.com/
The Associated Press reports that the families of two children sickened
by the E. coli bacteria are suing a Fresno dairy. The lawsuits filed Thursday
in Fresno County Superior Court accuse Organic Pastures Dairy Co. of shipping
raw milk tainted with the bacteria to stores in September 2006. That's
when at least five children fell ill after consuming the dairy's products.
Testing at Organic Pastures did not detect the strain of E. coli that
sickened some of the children, but a government report last February said
the dairy was likely responsible.
Eleven-year-old Lauren Herzog and 9-year-old Chris Martin both consumed
raw milk produced by Organic Pastures in early September of 2006. Lauren
became ill with symptoms of E. coli infection on September 6. Her illness
subsequently developed into HUS, a life-threatening complication of E.
coli infection that can cause kidney failure and central nervous system
impairment, and she was hospitalized on September 8. Lauren suffered acute
renal failure and required approximately two weeks of daily kidney dialysis.
She remained hospitalized until October 18, 2006, when she was discharged
with over $250,000 in medical bills.
Chris became ill with symptoms of E. coli infection on September 5, 2006
and he was hospitalized on September 7. Like Lauren, Chris suffered HUS.
His condition worsened and he was transported by helicopter to a Children¡¯s
hospital and was placed in pediatric intensive care. Chris¡¯ kidneys failed
and he required weeks of daily dialysis, as well as multiple blood transfusions.
He was placed on a ventilator as a result of impending congestive heart
failure, and remained on the ventilator for five days, was briefly taken
off the ventilator, and later returned for several more days. Chris suffered
a number of seizures as a result of his HUS. He also developed high blood
pressure and pancreatitis. Chris was discharged from the hospital on November
2, 2006, nearly two months after he was admitted, with over $450,000 in
medical bills.
FDA Plans
50-State Meeting on Food Safety
Source of Article: http://www.freshplaza.com/news_detail.asp.id=15989
Food and Drug Administration Commissioner Dr. Andrew von Eschenbach and
Dr. David Acheson, associate commissioner for foods, announced during
a conference call with the commissioners, secretaries, and directors of
the state agriculture departments and state health agencies that the agency
plans to hold a 50-state meeting later this year. FDA is in the early
planning stages for the meeting and no specifics have been announced at
this time.
The meeting will revolve around the administration's Food Protection Plan
and representatives from all FDA headquarters/regions/districts and states/locals
will be involved. The August 2008 meeting will be similar to the 50 state
meeting held in 1998 which had active NASDA participation.
FDA hopes that this will be the first in a succession of regular 50-state
meetings in the future. NASDA expressed support for the meeting during
the initial conference call and offered to help assist as the planning
gets underway.
Source: wisconsinagconnection.com
Charm Sciences:
New Test for Ochratoxin
Charm Sciences is proud to announce the first Lateral Flow
Quantitative test for Ochratoxin in grain and feedstuffs.
February 7, 2008
The ROSA¢ç Quantitative kit delivers fast, economical, accurate detection
for Ochratoxin A in a convenient single strip, Rapid One-Step strip Assay.
The ROSA Ochratoxin kit has the flexibility to meet domestic and export
requirements with quantitative readings and a detection range from 0 to
12 ppb. A dilution step expands the range from 10 . 150 ppb.
Following a methanol extraction, the diluted sample is added to the ROSA
OCHRA strip and read after 10 minutes. The ROSA-M reader stores Ochratoxin
results electronically for record keeping and reporting. Optional mycoSOFT¢â
software delivers flexible and intuitive functionality with customized
data trending reports.
The ROSA Ochratoxin lateral flow tests require minimal equipment and user
involvement. Multiple samples can be prepared, and tested at the same
time. ROSA test strips are uniquely packaged so that the strip only comes
in contact with the sample. The ROSA Ochratoxin kit uses the same extraction
as the GIPSA approved quantitative ROSA methods for aflatoxin and zearalenone.
The ROSA Ochratoxin kit shares the same equipment and assay format as
the ROSA quantitative methods for aflatoxin and zearalenone, and the same
equipment as the GIPSA approved ROSA Quantitative method for DON.
Ochratoxin is produced by some species of Aspergillus, such as A. ochraceus,
mainly in tropical regions and by Penicillium verrucosum in cooler climates.
Ochratoxin A is associated with porcine nephropathy and various symptoms
in poultry. Ochratoxin is found in wheat, barley, corn, oats, soybeans,
coffee beans, grapes, and raisins.
Charm Sciences is a world leader in the provision of food safety diagnostics
and food safety solutions with a proven track record of innovation and
development over the last 30 years. Introduced in 1999, Charm¡¯s ROSA lateral
flow tests are now the leading residue diagnostic tests employed by food
industry worldwide. The ROSA test portfolio covers the ¡°A to Z¡± in mycotoxins,
ranging from Aflatoxin to Zearalerone. Charm Sciences provides award-winning
product support and technical assistance.
Contact: Charm Sciences, Inc Telephone: +1.978.687.9200
Food Safety and Quality Related Job Openings
QUALITY
CONTROL TECHNICIAN - Premio Foods, Inc. - North & Central NJ
Instrumentation Chemistry Manager - Northland Laboratories . Northbrook
IL
GMP & Validation Coordinator - Prayon Inc.- Augusta, GA
Quality Assurance Manager - Kelly Scientific Resources . Westminster,
CO
Sanitation/Food Safety Resource . Kellogg¡¯s . Lancaster, PA
Director of Quality Services - Pepper Source, Ltd. - Van Buren, AR
Food Safety
and Quality Related Job Openings
Enterobacter
sakazakii: Infections Associated with Powdered Infant Formula
Posted on February 5, 2008 by Food Poisoning Attorney
Source of Article: http://www.marlerblog.com/
Enterobacter sakazakii is a gram-negative rod-shaped bacterium within
the family Enterobacteriaceae. The organism was called "yellow-pigmented
Enterobacter cloacae" until 1980 when it was renamed Enterobacter
sakazakii. The majority of cases of infection reported in the peer-reviewed
literature have described neonates with sepsis, meningitis, or necrotizing
enterocolitis as a consequence of the infection. (1)
E. sakazakii is a rare cause of bloodstream and central nervous system
infections. The organism has also been associated with necrotizing enterocolitis;
however, it has not been firmly established as a causative agent. Reported
outcomes are often severe: seizures; brain abscess; hydrocephalus; developmental
delay; and death in as many as 40%.80% of cases. Premature infants are
thought to be at greater risk than more mature infants, other children,
or adults, and outbreaks of disease have occurred in hospital units for
newborns. (2)
E. sakazakii was first implicated in a case of neonatal meningitis in
1958, and since then there have been around 70 reported cases of E. sakazakii
infection. However, it is likely that E. sakazakii is significantly under-reported
in all countries. Although E. sakazakii can cause illness in all age groups,
infants are believed to be at greatest risk of infection. (3)
Experts from the Food and Agriculture Organization of the United Nations
(FAO) and the World Health Organization (WHO) met in 2004 to summarize
information, and develop international guidelines and educational messages.
The meeting confirmed that there is very little known about virulence
factors and pathogenicity of E. sakazakii. The work done by Pagotto et
al. (2003) was the first describing putative virulence factors for E.
sakazakii. Enterotoxin-like compounds were produced by some strains. Using
tissue cultures, some strains produced a cytotoxic effect. Two strains
(out of 18 isolates) were capable of causing death in suckling mice by
the peroral route. Therefore, there appear to be differences in virulence
among E. sakazakii strains, and some strains may be non-pathogenic. (4)
Mortality rates from E. sakazakii infection have been reported to be as
high as 50 percent or more, but this figure has declined to under 20 percent
in recent years. Significant morbidity in the form of neurological deficits
can result from infection, especially among those with bacterial meningitis
and cerebritis. While the disease is usually responsive to antibiotic
therapy, a number of authors have reported increasing antibiotic resistance
to drugs commonly used for initial treatment of suspected Enterobacter
infection. Long-term neurologic sequelae are well recognized. (4)
Enterobacter sakazakii kills 40%.80% of infected infants. In 2007, the
CDC analyzed 46 cases of invasive infant E. sakazakii infection to define
risk factors and guide prevention and treatment. Twelve infants had bacteremia,
33 had meningitis, and 1 had a urinary tract infection. Compared with
infants with isolated bacteremia, infants with meningitis had greater
birthweight (2,454 g vs. 850 g, p = 0.002) and gestational age (37 weeks
vs. 27.8 weeks, p = 0.02), and infection developed at a younger age (6
days vs. 35 days, p<0.001). Among meningitis patients, 11 (33%) had
seizures, 7 (21%) had brain abscess, and 14 (42%) died. (2)
Although E. sakazakii can cause illness in all age groups, infants (children
<1 year) are at most risk, with neonates and infants under two months
at greatest risk. The groups of infants at greatest risk includes in particular
pre-term infants, low-birth-weight (<2.5 kg) infants or immunocompromised
infants. However, infants who are compromised for any other reason may
also be at greater risk of E. sakazakii infection. Infants of HIVpositive
mothers are also at risk because they may be immunocompromised, and may
specifically require powdered infant formula (PIF). (3)
There appear to be two distinct infant risk groups for E. sakazakii infection:
prematureinfants who develop bacteraemia after one month of age, and term
infants who develop meningitis during the neonatal period. Therefore,
an FAO/WHO expert working group in 2006 concluded that while infants appear
to be the group at particular risk, neonates and those less than two months
of age are at greatest risk. (3)
In the United States of America, an incidence rate of 1 per 100 000 infants
for E. sakazakii infection has been reported. This incidence rate increases
to 9.4 per 100 000 in infants of very low birth weight, i.e. <1.5 kg.
(3)
While the reservoir for E. sakazakii is unknown in many cases, a growing
number of reports have established powdered infant formula as the source
and vehicle of infection. In several investigations of outbreaks of E.
sakazakii infection that occurred among neonates in neonatal intensive
care units, investigators were able to show both statistical and microbiological
association between infection and powdered infant formula consumption.
These investigations included cohort studies which implicated infant formula
consumed by the infected infants. In addition, there was no evidence of
infant-to-infant or environmental transmission; all cases had consumed
the implicated formula. The stomach of newborns, especially of premature
babies, is less acidic than that of adults: a possible important factor
contributing to the survival of an infection with E. sakazakii in infants.
(4)
Limited information was available on the numbers of E. sakazakii organisms
that ill patients were exposed to in any of the various outbreaks. It
is therefore not possible to develop a dose-response curve for E. sakazakii.
However, it is possible that a small number of cells present in PIF could
cause illness. This risk increases rapidly when bacteria in the reconstituted
formula are allowed to multiply, such as by holding at inappropriate temperatures
for an extended period. (3)
The frequency of intrinsic E. sakazakii contamination in powdered infant
formula is of concern, even though intrinsic concentration levels of E.
sakazakii appear to be typically very low. In a study of the prevalence
of E. sakazakii contamination in 141 powdered infant formulas, 20 were
found culture-positive, yet all met the microbiological specifications
for coliform counts in powdered infant formula (<3 cfu/g) of the current
Codex code. Such formula has been linked to outbreaks. (4)
Furthermore, outbreaks have occurred in which the investigators have failed
to identify lapses in formula preparation procedures. Thus, it seems that
neither high levels of contamination nor lapses in preparation hygiene
are necessary to cause infection from E. sakazakii in powdered infant
formula. While it can be assumed that lapses in preparation hygiene or
extended holding at non-refrigerated temperatures could lead to increases
in the levels of contamination at the time of consumption, it is not possible
to assess the contribution that these factors have on the cases of infection
that have been associated with powdered infant formula that contained
low levels of E. sakazakii. Thus it must be currently assumed that low
levels of E. sakazakii in infant formula (<3 cfu/100 g) can lead to
infections. (4)
In the April 12th 2002 issue of Morbidity and Mortality Weekly Report,
the Centers for Disease Control and Prevention (CDC) reported on a fatal
case of meningitis in an intensive care nursery in Tennessee. The infecting
organism was E. sakazakii, an unusual but often fatal, invasive pathogen.
In the fatal Tennessee case, the infection was traced to contaminated
powdered infant formula. Other infants in the same nursery were screened
for E sakazakii. Of 49 screened infants, 10 events were discovered (1
proven infection, 2 assumed infections, and 7 colonizations). This report
detailed for the first time a direct link to an unopened product. The
manufacturer voluntarily recalled the contaminated batch of powdered formula
identified as the source. (5)
In 2004, PIF was microbiologically linked to two E. sakazakii outbreaks,
in New Zealand and in France. The French outbreak involved nine cases,
and resulted in the death of two infants. While eight of the cases were
in premature infants of low birth weight (<2 kg), one case was in an
infant born at 37 weeks and weighing 3.25 kg. The outbreak involved five
hospitals, and a review of practices in the hospitals revealed that one
hospital was not following recommended procedures for the preparation,
handling and storage of feeding bottles, and four were storing reconstituted
formula for >24 hours in domestic-type refrigerators, with no temperature
control or traceability. (3)
The FDA points out that powdered infant formulas are not commercially
sterile products. Powdered milk-based infant formulas are heat-treated
during processing, but unlike liquid formula products they are not subjected
to high temperatures for sufficient time to make the final packaged product
commercially sterile. FDA has noted that infant formulas nutritionally
designed for consumption by premature or low birth weight infants are
available only in commercially sterile liquid form. However, so-called
"transition" infant formulas that are generally used for premature
or low birth weight infants after hospital discharge are available in
both non-commercially sterile powder form and commercially sterile liquid
form. Some other specialty infant formulas are only available in powder
form. (1)
The FDA has become increasingly aware that a substantial percentage of
premature neonates in neonatal intensive care units are being fed non-commercially
sterile dry infant formula. In light of the epidemiological findings and
the fact that powdered infant formulas are not commercially sterile products,
FDA recommends that powdered infant formulas not be used in neonatal intensive
care settings unless there is no alternative available. If the only option
available to address the nutritional needs of a particular infant is a
powdered formula, risks of infection can be reduced by:
. Preparing only a small amount of reconstituted formula for each feeding
to reduce the quantity and time that formula is held at room temperature
for consumption; Recognizing differences in infant formula preparation
among hospitals, individual facilities should identify and follow procedures
appropriate for that institution to minimize microbial growth in infant
formulas;
. Minimizing the holding time, whether at room temperature or while under refrigeration, before a reconstituted formula is fed; and
. Minimizing the "hang-time" (i.e., the amount of time a formula is at room temperature in the feeding bag and accompanying lines during enteral tube feeding), with no "hang-time" exceeding 4 hours. Longer times should be avoided because of the potential for significant microbial growth in reconstituted infant formula. (1)
WHO recommends that infants should be exclusively breastfed for the first six months of life to achieve optimal growth, development and health. Thereafter, to meet their evolving nutritional requirements, infants should receive nutritionally adequate and safe complementary foods while breastfeeding continues for up to two years of age or beyond (WHO/UNICEF, 2003). It is important to support breastfeeding and promote its benefits to infants and young children. (3)
There are, however, instances where breast milk is not available, where the mother is unable to breastfeed, where they have made an informed decision not to breastfeed, or where breastfeeding is not appropriate, e.g. where the mother is taking medication that is contraindicated for breastfeeding or the mother is HIV-positive. Similarly, some very low-birth-weight babies may not be able to breastfeed directly, and in some cases expressed breast milk may not be available at all or available in insufficient quantities. Infants who are not breastfed require a suitable breast-milk substitute, for example, an infant formula prepared in accordance with the present guidelines. WHO Guidelines for infant formula preparation, storage, and handling (2007), in both care settings and at home, are specified at http://www.who.int/foodsafety/publications/micro/pif (3)
In January 2006, a second meeting (after the initial one in 2004) of experts from the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) took place to summarize information, and develop international guidelines and educational messages. The meeting participants first re-endorsed the recommendations made by the 2004 FAO/WHO meeting on this issue. The additional recommendations made by the expert meeting to member countries included the following:
. Develop prevention strategies for E. sakazakii infections caused by contaminated PIF that address the different stages of production and preparation and use of PIF, taking into consideration the risk to infants .both within and beyond the neonatal period and of any immune status.
. Develop educational messages on the safe handling, storage and use of powdered infant formula, including the health hazards of inappropriate preparation and use; target healthcare workers, parents and other caregivers, in both hospitals and the community, since E. sakazakii infections have occurred in hospital and home settings.
. Review and revise product labels, as appropriate, to enable caregivers to handle, store and use the product safely, and to make clear the health hazards of inappropriate preparation.
. Encourage member countries to establish surveillance and rapid response networks, and facilitate coordinated investigation by clinicians, laboratorians, and public health and regulatory officials, to enable the timely recognition and cessation of outbreaks of illness associated with E. sakazakii and the identification of contaminated PIF. (6)
REFERENCES:
(1) ¡°Health Professionals Letter on Enterobacter sakazakii Infections
Associated With use of Powdered (Dry) Infant Formulas in Neonatal Intensive
Care Units¡±, U. S. Department of Health and Human Services, U. S. Food
and Drug Administration, April 11, 2002; Revised October 10, 2002.
(2) ¡°Invasive Enterobacter sakazakii Disease in Infants¡±, Emerging Infectious
Diseases, Volume 12, Number 8.August 2006.
(3) ¡°Safe Preparation, Storage and Handling of Powdered Infant Formula
Guidelines¡± (2007), World Health Organization, in collaboration with Food
and Agriculture Organization of the United Nations.
(4) ¡°Enterobacter sakazakii and other microorganisms in powdered infant
formula¡± Microbiological Risk Assessment Series 6, World Health Organization
(2004).
(5) ¡°Enterobacter sakazakii Infections Associated With the Use of Powdered
Infant Formula.Tennessee, 2001¡±, JAMA. 2002; 287:2204-2205, Vol. 287 No.
17, May 1, 2002.
(6) ¡°Enterobacter sakazakii and Salmonella in powdered infant formula:
Meeting report, MRA Series 10¡±, Microbiological Risk Assessment Series
10, World Health Organization (2006).
USDA Agrees
to Grant Conditional License to Bioniche for its E. coli O157:H7 Cattle
Vaccine
Source of Article: http://www.foxbusiness.com/
BELLEVILLE, ON, Feb 05, 2008 /PRNewswire-FirstCall via COMTEX/ -- Bioniche
Life Sciences Inc. (TSX: BNC), a research-based, technology-driven Canadian
biopharmaceutical company, today received notice from the United States
Department of Agriculture (USDA) that the latest data for its E. coli
O157:H7 cattle vaccine "meets the 'expectation of efficacy' standard"
and is eligible for a conditional license, providing that the Company
develops a plan "that would collect sufficient data to move the product
to full licensure". The conditional license, when granted, will provide
the Company full access to the U.S. market with two restrictions: At least
one step in the manufacturing process must be performed in the United
States and Bioniche will not be permitted to use a trademark name for
the vaccine.
The Bioniche vaccine is the world's first vaccine that may be used as an on-farm intervention to reduce the amount of E. coli O157:H7 shed by cattle. Bioniche and its collaborators have been moving the vaccine towards commercial availability for eight years and it has been extensively tested at the University Nebraska-Lincoln, with efficacy results now being published in peer-reviewed scientific journals, most recently, the Journal of Food Protection, in November, 2007. The E. coli O157:H7 cattle vaccine will be manufactured in the Bioniche production facility in Belleville, Ontario, Canada where a two-year, $25 million expansion is taking place. Vaccine supply will be limited during this manufacturing expansion period.
"This is a large step forward for the E. coli O157:H7 vaccine," said Graeme McRae, President & CEO of Bioniche Life Sciences Inc. "The granting of a U.S. conditional license will permit U.S. beef and dairy producers access to a scientifically-validated means to reduce the risk of E. coli O157:H7 contamination."
Rick Culbert, President of Bioniche Food Safety, added, "There are an estimated 97 million cattle in the United States, many of which carry and shed E. coli O157:H7. We look forward to working with producers to implement vaccination as the first licensed on-farm intervention for E. coli risk reduction."
In order to begin providing vaccine to U.S cattle producers, the Company is required to produce three validated production lots, which will be filled in the United States, in accordance with the Virus-Serum-Toxin Act of 1913, as amended 1985.
It has taken some months for USDA reviewers to complete their assessment of vaccine efficacy data against a pathogen with a complex life cycle in variable real-world environments. Both the USDA and Bioniche have been diligently working through these challenging issues with a view to benefiting public health and the cattle industry. "We are very pleased that the USDA reviewers recognize the scientific merit and importance to the market of this vaccine," added Mr. McRae. "The vaccine is especially novel in that it reduces shedding of an organism that, while potentially lethal to humans, causes no disease in cattle. As a result, it was particularly challenging for regulators - understanding the many implications of this vaccine as a tool in reducing the shedding and colonization of E. coli O157:H7 in cattle."
Food recalls due to E. coli O157:H7 contamination continue to be a concern in beef, produce and prepared food. On-farm interventions to reduce the shedding of E. coli O157:H7 by cattle, such as vaccination, may assist in reducing the potential for food and water contamination and the resulting human illnesses and deaths.
Approximately 100,000 cases of human infection with the E. coli O157:H7 organism are reported each year in North America. 2% to 7% of those people develop hemolytic uremic syndrome (HUS), a disease characterized by kidney failure (in recent outbreaks, this percentage has risen to as high as 16%). Five percent of HUS patients die, many of them children and senior citizens, whose kidneys are more sensitive to damage.
In addition to being infected by contaminated food or water, individuals can become infected from E. coli O157:H7 by visiting animal exhibits. Petting zoos, fairs, and agricultural exhibits provide many possible routes of transmission for E. coli. Direct animal contact is the obvious route, but contact with contaminated products (e.g., sawdust, shavings, soiled clothing or shoes) can also lead to human infection.
About the E. coli O157:H7 Cattle Vaccine
This vaccine received international recognition in September, 2007 by the Animal Pharm Industry Excellence Awards as the best new veterinary product for livestock globally. The vaccine has been developed by a strategic alliance formed in 2000 between the University of British Columbia (UBC), the Alberta Research Council (ARC), the University of Saskatchewan's Vaccine & Infectious Disease Organization (VIDO), and Bioniche, which holds the rights for worldwide commercialization of the vaccine. The vaccine prevents the E. coli O157:H7 bacteria from attaching to the intestines of vaccinated cattle, thereby reducing their reproduction within the animal, and reducing the amount of bacteria that can be released through cattle manure in the environment. More than 30,000 cattle have been involved in clinical testing of the vaccine over the past five years.
About Bioniche Life Sciences Inc.
Bioniche Life Sciences Inc. is a research-based, technology-driven Canadian biopharmaceutical company focused on the discovery, development, manufacturing, and marketing of proprietary products for human and animal health markets worldwide. The fully-integrated company employs approximately 200 skilled personnel and has three operating divisions: Human Health, Animal Health, and Food Safety. The Company's primary goal is to develop proprietary cancer therapies supported by revenues from marketed products in human and animal health. Bioniche has been named one of Canada's Top Ten Life Sciences Companies for 2008. For more information, please visit www.Bioniche.com.
Except for historical information,
this news release may contain forward-looking statements that reflect
the Company's current expectation regarding future events. These forward-looking
statements involve risk and uncertainties, which may cause, but are not
limited to, changing market conditions, the successful and timely completion
of clinical studies, the establishment of corporate alliances, the impact
of competitive products and pricing, new product development, uncertainties
related to the regulatory approval process, and other risks detailed from
time to time in the Company's ongoing quarterly and annual reporting.
SOURCE Bioniche Life Sciences Inc
FDA looks
for "boots on the ground" in China
Tue Feb 5, 2008
Source of Article: http://www.reuters.com/article/topNews/idUSN0518943220080205.sp=true
WASHINGTON (Reuters) - The United States is hoping to bolster the safety
of food and other products imported from China by opening a new Food and
Drug Administration office in the Asian nation.
"We will be able to continue to expand our own ability to leverage,
beyond simply sending inspectors over, but to have people in place,"
FDA Commissioner Andrew von Eschenbach said during the Reuters Regulatory
Summit here.
"We're boots on the ground," he said.
FDA officials see the office, which must be approved by the Chinese government
and funded by Congress, as a model for outposts elsewhere, which in an
era of globalized trade would shift much of the burden for safe imports
to producer countries instead of relying on inspections at home.
Von Eschenbach said FDA officials in China, rather than regularly patrolling
factories, would seek to create more stringent safety standards among
producers and would look to strengthen regulation by Chinese government.
Basing officials in China would also allow the FDA to move quickly when
problems do arise, rather than having to secure visas or make long trips
before setting off to inspect problem facilities.
The FDA, responsible for more than three-quarters of the U.S. food supply,
has been struggling to restore its sheen following a spate of food safety
scares, some involving imports, jolted consumer confidence in the past
18 months.
Despite a new, administration-wide initiative to improve safety of food
and other consumer goods, critics say the FDA remains underfunded and
ineffective.
The FDA's proposal for a China office appeared in U.S. President George
W. Bush's budget proposal for fiscal 2009, which was released on Monday.
It underscores the administration's belief that it "cannot inspect
its way" to safe food across the country. The FDA now inspects only
a tiny share of the food under its authority.
Under the president's budget proposal, FDA food safety spending at the
FDA would grow by less than 10 percent, focusing on heading off problems
with contaminated or otherwise unsafe food before it enters the marketplace.
While officials stress that China is not the sole source of worry, the
Asian nation is now a major supplier of U.S. consumer goods. Some of the
most high-profile scares have involved Chinese goods, such as pet food,
seafood, and toys.
How the United States grapples with these challenges with China, with
whom it shares a huge and often tense trade relationship, may be a signal
of how it manages the task worldwide.
Von Eschenbach said the United States had yet to secure approval from
the Chinese government, but characterized Beijing's approach to food safety
as "open" and "cooperative."
The two countries have already signed several memoranda on product safety.
Von Eschenbach did not specify when the office might open.
"Obviously, I'd like to do it as soon as possible. We have money
set aside in 08/09 budgets," he said.
(For summit blog: summitnotebook.reuters.com/)
(Additional reporting by John Crawley; Editing by Russell Blinch, Richard
Chang)
Salmonella
Outbreak Sickens 33 Leading to Recall of Ahi in Hawaii
Posted on February 8, 2008 by Salmonella Lawyer
Source of Article: http://www.marlerblog.com/
The Honolulu Star-Bulletin reported again on the ongoing story last week
of about 33 illness of Salmonella Paratyphi B tied to the consumption
of yellow fin Tuna Ahi. Now Choyce Products announced that it has voluntarily
recalled 11,000 pounds of previously frozen yellow fin tuna that tested
positive for salmonella. About 5,000 pounds of the contaminated Ahi was
sold to some five businesses, but it is not clear how much was recovered
or if any had already been sold to consumers.
The Health Department believes the illnesses are related to previously
frozen ahi, which was imported to Hawaii and eaten raw.
Salmonella Paratyphi B is host-specialized, for it grows well and causes
disease only in humans, whereas most strains of Salmonella can grow in
the gut of almost all animals, both domesticated and wild. Humans usually
acquire Salmonella Paratyphi B by the ingestion of water or of food that
has been contaminated through fecal contact with humans. Most isolates
of Salmonella belong to the species S. enterica, which is further subdivided
into many serovars based on antigens on their surface; one of these serovars
is Paratyphi B. Paratyphi B is quite diverse and human infection is sometimes
not associated with human to human system infection but rather associated
with foodborne infection (Prager et al, 2003). Hawaii would be a good
trip to take this time of year.
Toxins in
Fish Sicken At Least 28 in Several U.S. States
Wednesday, February 06, 2008
Source of Article: http://www.foxnews.com/story/0,2933,328850,00.html
Several outbreaks of ciguatera fish poisoning have been confirmed in consumers
who ate fish harvested in the northern Gulf of Mexico, the Food and Drug
Administration said this week.
The FDA said that fish such as grouper, snapper, amberjack and barracuda
represent the most significant threat to consumers. They feed on fish
that have eaten toxic marine algae. The toxin is stable in the tissue
of living fish and does them no harm. But larger carnivores have higher
concentrations of the toxin in their tissues. As a result, the greatest
risk of poisoning for humans comes from the largest fish.
Symptoms of ciguatera poisoning include nausea, vomiting, vertigo and
joint pain. In the most serious cases, neurological problems can last
for months or even years. Several outbreaks of the illness were confirmed
in Washington, D.C., and St. Louis, the FDA said. Overall, there have
been at least 28 reported cases across the country, with the first case
being reported in late November.
The fish linked to the illnesses were harvested near the Flower Garden
Banks National Marine Sanctuary, an area of 56 square miles in the northwestern
Gulf. The FDA recommends that processors not purchase fish harvested near
the sanctuary.
Ciguatera is common in fish living in tropical and subtropical regions,
including the Caribbean Sea, the South Pacific Ocean and the Indian Ocean.
But the FDA has considered it rare for fish in the northern Gulf of Mexico
to have the toxin.
The FDA warned processors to reassess their hazard control plans as necessary,
and that failure to take proper precautions may cause products to be considered
adulterated by the agency. Consumers who think they may have ciguatera
poisoning are encouraged to report their symptoms and what fish they ate
to a doctor or local health department.
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