BSE TSE PRION USDA FDA MAD COW FEED COMPLIANCE REPORT and NAI, OAI, and VAI
ratings as at June 5, 2013
Greetings,
since our fine federal friends have decided not to give out any more
reports on the USA breaches of the feed ban and surveillance etc. for the BSE
TSE prion mad cow type disease in the USDA livestock, I thought I might attempt
it. I swear, I just don’t understand the logic of the SSS policy, and that
includes all of it. I assure you, it would be much easier, and probably better
for the FDA and the USDA INC., if they would simply put some kind of report out
for Pete’s sake, instead of me doing it after I get mad, because I am going to
put it all out there. the truth.
PLEASE BE ADVISED, any breach of any of the above classifications OAI, VAI,
RTS, CAN lead to breaches into the feed BSE TSE prion protocols, and CAN lead to
the eventual suspect tainted feed reaching livestock. please, if any USDA
official out there disputes this, please explain then how they could not.
paperwork errors can eventually lead to breaches of the BSE TSE prion mad cow
feed ban reaching livestock, or contamination and exposure there from, as well.
I would sure like to see the full reports of just these ;
4018 CHI-DO 3007091297 Rancho Cantera 2866 N Sunnyside Rd Kent IL
61044-9605 OPR FR, OF HP 11/26/2012 OAI Y
9367 3008575486 Rocky Ford Pet Foods 21693 Highway 50 East Rocky Ford CO
81067 OPR RE, TH HP 2/27/2013 OAI N
9446 DEN-DO 1713202 Weld County Bi Products, Inc. 1138 N 11th Ave Greeley
CO 80631-9501 OPR RE, TH HP 10/12/2012 OAI N
9447 DEN-DO 3002857110 Weld County Bi-Products dba Fort Morgan Pet Foods
13553 County Road 19 Fort Morgan CO 80701-7506 OPR RE HP 12/7/2011 OAI N
see full list of the fda mad cow bse feed follies, toward the bottom, after
a short brief update on the mad cow bse follies, and our good friend Lester
Crawford that was at the FDA.
ALSO, I would kindly like to comment on this FDA BSE/Ruminant Feed
Inspections Firms Inventory (excel format)4 format, for reporting these breaches
of BSE TSE prion protocols, from the extensive mad cow feed ban warning letters
the fda use to put out for each violations. simply put, this excel format sucks,
and the FDA et al intentionally made it this difficult to follow the usda fda
mad cow follies. this is an intentional format to make it as difficult as
possible to follow these breaches of the mad cow TSE prion safety feed
protocols. to have absolutely no chronological or numerical order, and to format
such violations in a way that they are almost impossible to find, says a lot
about just how far the FDA and our fine federal friends will go through to hide
these continued violations of the BSE TSE prion mad cow feed ban, and any
breaches of protocols there from. once again, the wolf guarding the henhouse $$$
NAI = NO ACTION INDICATED
OAI = OFFICIAL ACTION INDICATED
VAI = VOLUNTARY ACTION INDICATED
RTS = REFERRED TO STATE
Inspections conducted by State and FDA investigators are classified to
reflect the compliance status at the time of the inspection, based upon whether
objectionable conditions were documented. Based on the conditions found,
inspection results are recorded in one of three classifications:
OAI (Official Action Indicated) when inspectors find significant
objectionable conditions or practices and believe that regulatory sanctions are
warranted to address the establishment’s lack of compliance with the regulation.
An example of an OAI classification would be findings of manufacturing
procedures insufficient to ensure that ruminant feed is not contaminated with
prohibited material. Inspectors will promptly re-inspect facilities classified
OAI after regulatory sanctions have been applied to determine whether the
corrective actions are adequate to address the objectionable conditions.
VAI (Voluntary Action Indicated) when inspectors find objectionable
conditions or practices that do not meet the threshold of regulatory
significance, but warrant an advisory to inform the establishment that
inspectors found conditions or practices that should be voluntarily corrected.
VAI violations are typically technical violations of the 1997 BSE Feed Rule.
These violations include minor recordkeeping lapses or conditions involving
non-ruminant feeds.
NAI (No Action Indicated) when inspectors find no objectionable conditions
or practices or, if they find objectionable conditions, those conditions are of
a minor nature and do not justify further actions.
when sound science was bought off by junk science, in regards to the BSE
TSE prion mad cow type disease, by the USDA, CFIA, WHO, OIE, et al. $$$
when the infamous, and fraudulently USDA, FSIS, APHIS, FDA, gold card was
taken away that infamous day in December of 2003, all cards were off the table,
it was time to change the science, and change they did. ...tss
about those triple BSE TSE PRION MAD COW FIREWALLS ???
On January 6, 2004, over 2 weeks from recall initiation, USDA determined
that the beef went to only six states—Washington, Oregon, California, Nevada,
Idaho, and Montana—and that no beef went to Alaska, Hawaii, or Guam. To reach
that conclusion, USDA used the distribution lists, shipping records, and sales
invoices that it received from companies to piece together exactly where the
recalled beef may have been sent. The lists showed that 713 customers may have
received the recalled beef; 6 of those may have received beef from more than one
source. USDA determined that 176 customers on the lists did not actually receive
recalled beef, including the customers in Guam and Hawaii. USDA’s review also
indicated that recalled beef was probably not shipped to Alaska or Utah, and
USDA checked 2 retailers in Alaska and 3 retailers in Utah to confirm that was
the case. In total, USDA conducted verification checks on 537 of the 713
customers on the lists. USDA’s initial checks identified an additional 45
customers that may have received the recalled beef that were not included on the
distribution lists, for a total of 582 verification checks. Figure 4 summarizes
USDA’s verification efforts during the recall.
SNIP...
USDA’s press release stated that the recall involved 10,410 pounds of beef
products, and the USDA recall coordinator for this recall told us that
downstream processors mixed the recalled beef with nonrecalled beef, for a total
of more than 38,000 pounds of beef that was distributed at the secondary
customer level. According to USDA officials involved with the recall, the
precise amount of meat that was sold at the retail level is unknown because
retailers at the tertiary level further mixed nonrecalled meat with potentially
contaminated meat. USDA told us that more than 64,000 pounds of beef was
ultimately returned or destroyed by customers, and that, because of the mixing,
it was not able to determine how much of the original 10,410 pounds of recalled
beef was contained in the 64,000 pounds that were recovered.
Parts of the BSE-infected animal slaughtered on December 9, 2003, were not
used for food, but they were sent to renderers to be separated into raw
materials, such as proteins and blood. Rendered materials are used for many
purposes, including cosmetics and vaccines. FDA has jurisdiction over
renderers.
SNIP...
QFC sued over mad cow case
Grocer negligently exposed them to beef, family claims
Friday, March 5, 2004
SNIP...please see full text and more here ;
Sunday, November 13, 2011
California BSE mad cow beef recall, QFC, CJD, and dead stock downer
livestock
January 27, 2004
Bovine Spongiform Encephalopathy (BSE) Statement of
Lester M. Crawford, D.V.M., Ph.D. Deputy Commissioner of Food and Drugs
Department of Health and Human ServicesS
before
the Senate Committee on Agriculture, Nutrition, and Forestry
January 27, 2004
INTRODUCTION
Mr. Chairman, Members of the Committee, thank you for the opportunity to
participate in today’s hearing on measures taken by the Federal government to
safeguard human and animal health in the United States from Bovine Spongiform
Encephalopathy (BSE) and the response to the finding of a BSE-positive cow in
the State of Washington. I am Dr. Lester M. Crawford, Deputy Commissioner, Food
and Drug Administration (FDA or the Agency).
The mission of FDA is to protect the public health by assuring the safety
and efficacy of our nation’s human and veterinary drugs, human biological
products, medical devices, human and animal food supply, cosmetics, and
radiation emitting products. In fulfilling this mission, FDA is the Agency
responsible for assuring that all FDA-regulated products remain safe and
uncompromised from BSE and related diseases. Many FDA-regulated products contain
bovine ingredients, for example, heart valves, ophthalmic devices, dental
products, wound dressings, injectable drugs, vaccines, soups, gravies, sausage
casings, and animal feeds.
FDA has long been actively involved nationally and internationally in
efforts to understand and prevent the spread of BSE. FDA collaborates
extensively with the Centers for Disease Control and Prevention (CDC), the
National Institutes of Health (NIH), the Animal and Plant Health Inspection
Service (APHIS) and the Food Safety and Inspection Service (FSIS) within the
U.S. Department of Agriculture (USDA), Customs and Border Protection (CBP), the
Environmental Protection Agency (EPA), other Federal agencies, state and local
jurisdictions, and with affected industries and consumer groups. Many of these
activities fit within the framework of the Department of Health and Human
Service’s (HHS or the Department) Bovine Spongiform Encephalopathy/Transmissible
Spongiform Encephalopathy (BSE/TSE) Action Plan, which was released in August
2001. This collaboration over many years has enabled FDA to strengthen
safeguards for FDA-regulated products and to respond quickly and effectively to
the first case of BSE within the U.S.
EXECUTIVE SUMMARY
The mission of the Agency is to protect the public health by assuring the
safety and efficacy of our nation’s human and veterinary drugs, human biological
products, medical devices, human and animal food supply, cosmetics, and
radiation emitting products. In fulfilling this mission, FDA is the Agency
responsible for assuring that all FDA-regulated products remain safe and
uncompromised from BSE and related diseases.
BSE is a progressive neurological disorder of cattle that results from
infection by an unconventional transmissible agent, and was first diagnosed in
the United Kingdom (U.K.) in 1986. Many FDA-regulated products contain bovine
ingredients, for example, heart valves, ophthalmic devices, dental products,
wound dressings, injectable drugs, vaccines, soups, gravies, sausage casings,
and animal feeds and thus must be taken into consideration as part the effort to
prevent infectivity by BSE.
FDA has a longstanding commitment to protecting consumers from BSE by
following multiple measures designed to safeguard FDA-regulated products from
possible contamination by the BSE agent. Under the Federal Food, Drug, and
Cosmetic (FD&C) Act, FDA has the authority to prevent the adulteration and
misbranding of FDA-regulated products. Further, for medical products that
require pre-market approval (e.g., drugs under Section 505 and medical devices
under Section 513 of the FD&C Act), FDA has addressed safety concerns
related to BSE through requirements of the application and approval
process.
The U.S. employs a robust multi-layered approach to preventing the
introduction and amplification of BSE. While the goal of this approach is to
achieve an extremely high level of compliance with each preventative measure,
this multi-layered approach is designed to protect the U.S. consumer from
exposure to the BSE infective material, and to date this approach has been
working. Since 1989, USDA has prohibited the importation of live animals and
animal products from BSE-positive countries. Since 1997, FDA has prohibited the
use of certain mammalian proteins in the manufacture of ruminant feed. FDA
continues to implement policies to keep safe all FDA-regulated products,
including food, food ingredients, dietary supplements, drugs, vaccines, and
cosmetics from risk of any BSE-contaminated bovine material. As a result of
these multiple regulatory safeguards, the risk of exposure to BSE through
products, FDA regulates remains extremely low in the U.S.
FDA’s 1997 animal feed regulation forms the basis of the Agency’s efforts
to prevent the spread of BSE through animal feed. This rule prohibits the use of
most mammalian protein in the manufacture of animal feeds for ruminants. FDA
implemented this rule to establish in our country feeding practices consistent
with the best science and epidemiological knowledge known at the time to prevent
the spread of BSE throughout herds of U.S. cattle. A risk assessment sponsored
by USDA and conducted by the Harvard Center for Risk Analysis, released in
November 2001, identified FDA’s feed ban as one of the primary safeguards
against the spread of BSE in U.S. cattle.
To maximize protection afforded by the feed regulation, FDA has developed
and implemented a BSE/Ruminant Feed Ban Inspection compliance program and
established the goal of 100 percent compliance. FDA’s strategy for achieving
uniform compliance with the feed rule focuses on three areas: education,
inspection, and enforcement. FDA and its state counterparts conduct, at least
annually, targeted BSE inspections of 100 percent of known renderers, protein
blenders, and feed mills processing products containing material prohibited from
use in ruminant feed. Compliance by these establishments with FDA’s feed rule is
estimated to be at better than 99 percent. As of December 20, 2003, FDA had
received over 26,000 inspection reports (6,404 for Fiscal Year 2003). The
majority of these inspections (around 70 percent) were conducted by state
officials for FDA, with the remainder conducted by FDA officials. The total
number of inspection reports represents 13,672 firms, 1,949 of which are active
and handle materials prohibited from use in ruminant feed. The 1,949 active
firms that handle prohibited material have been inspected by FDA and, as of
December 31, 2003, only five were found to have significant violations,
resulting in official action indicated (OAI). FDA is working with these firms to
bring them into compliance.
On December 23, 2003, FDA was notified by USDA of a presumptive-positive
finding of BSE in a cow in Washington State. FDA immediately initiated its BSE
Emergency Response Plan. As part of the plan, FDA has been coordinately closely
with USDA so that we can effectively investigate this BSE case, trace the
various products involved, and take the appropriate steps to protect the public.
FDA investigators and inspectors located the high risk material rendered from
the infected cow, and the rendering plants placed a hold on the rendered
material, which is being disposed of appropriately. I am happy to report that
all of the establishments inspected by FDA during the course of the
investigation were in compliance with the feed ban. In addition, to help address
the concerns of foreign governments and restore confidence in American products,
FDA has participated, along with USDA, in numerous meetings and consultations
with foreign governments since USDA surveillance found the BSE-positive
cow.
In addition to new policies and regulations, new knowledge and tools gained
through applied research can greatly help us to be more effective in our
regulatory mission, such as protecting the country from BSE. Several of FDA’s
Centers, as well as many private laboratories, academic institutions, and other
Federal agencies (most notably NIH) are also involved in significant research
activities relating to TSEs. Basic areas requiring research include: increasing
our understanding of prions, learning how prions are transmitted within a
species and potentially between species, developing diagnostic tests for humans
and animals, developing detection methods for use on regulated products,
developing methods to increase or eliminate infectivity, and designing new
treatments. We are optimistic about the promise of new technologies, such as
better methods to quickly distinguish the species of proteins and sensors to
detect abnormal prions in food. Development of these technologies can contribute
significantly to the effort to prevent the spread of BSE and must be considered
carefully when evaluating potential regulatory changes to address BSE.
At the time that FDA implemented the feed rule in 1997, the Agency also
recognized that evolving, complex scientific and public health issues,
particularly regarding BSE required the Agency to continue to assess and
scrutinize the rule to ensure its integrity as a firewall against the potential
for spread of BSE. To further explore ways the animal feed regulation could be
improved in November 2002, FDA published an advance notice of proposed
rulemaking (ANPR) soliciting information and views from the affected industries
and the public on some potential changes to its current feed regulation,
including ways that the animal feed regulation could be strengthened. Although
the risk of exposure to BSE in the U.S. remains extremely low and the measures
in place are working, as a result of the recently discovered infected cow in the
state of Washington, the Agency is evaluating the appropriateness of additional
science-based measures to further strengthen our current protections.
Yesterday, Department Secretary Tommy Thompson and FDA Commissioner Mark
McClellan announced several additional public health measures to further
strengthen the current robust safeguards that help protect Americans from
exposure to the agent that causes BSE and help prevent the spread of BSE in U.S.
cattle. These measures relate to both protections for foods intended for human
consumption as well as additional measures to strengthen FDA’s 1997 final rule
regulating animal feed. With respect to human foods, FDA announced that it will
extend to FDA-regulated foods, dietary supplements and cosmetics, restrictions
on using specified risk materials that would complement the recent USDA
announcements. Concerning animal feed, the Agency announced a series of measures
designed to lower even further the risk that cattle will be purposefully or
inadvertently fed “ruminant” proteins, including, eliminating an exemption in
the feed rule that allows mammalian blood and blood products at slaughter to be
fed to ruminants as a protein source; banning the use of “poultry litter” as a
feed ingredient for cattle and other ruminants; prohibiting the use of “plate
waste” as a feed ingredient for ruminants, including cattle; and taking steps to
further minimize the possibility of cross-contamination of animal feed via
equipment, facilities or production lines.
Finally, FDA is increasing its inspections of feed mills and renderers in
2004. Our 2001 base funding for BSE-related activities was $3.8 million. We
shifted resources internally in 2001 and received a substantial increase from
Congress in 2002. Our funded level for 2004 is currently approximately $21.5
million, almost a five-fold increase over the 2001 base. FDA will itself conduct
2,800 inspections and will make its resources go even further by working with
state agencies to fund 3,100 contract inspections of feed mills and renderers
and other firms that handle animal feed and feed ingredients. Through
partnerships with states, FDA will also receive data on 700 additional
inspections, for a total of 3,800 state contract and partnership inspections in
2004. These inspections would include 100 percent of all known renderers and
feed mills that process products containing prohibited materials.
The Agency looks forward to continuing to assist Congress as it evaluates
the risks associated with BSE, identifies opportunities to promote technologies
that will detect and prevent the spread of BSE, and considers science-based
approaches to further strengthen regulatory protections and bolster the
resources available to assist Federal, state, local and private efforts to
assure that BSE does not present a threat to human or animal health in the
U.S.
BACKGROUND ON BOVINE SPONGIFORM ENCEPHALOPATHY (BSE)
BSE is a progressive neurological disorder of cattle that results from
infection by an unconventional transmissible agent, and was first diagnosed in
the U.K. in 1986. It belongs to a family of diseases, transmissible spongiform
encephalopathies (TSEs), a group of transmissible, slowly progressive,
degenerative diseases of the central nervous systems of several species of
animals.
The vast majority of BSE cases have been reported in the U.K., where more
than 183,000 cases in more than 35,000 herds have been reported through the end
of November 2003. The U.K.-BSE epidemic peaked in January 1993 at nearly 1,000
new cases per week. The original source of the BSE outbreak is uncertain, but
may have resulted from the feeding of scrapie-containing sheep meat-and-bone
meal to cattle. Scrapie is an endemic spongiform encephalopathy and has been
widespread in the U.K., where the rendered carcasses of livestock (including
sheep) were fed to ruminants and other animals until 1988, as a protein-rich
nutritional supplement. It appears likely that changes in the rendering process
in the U.K. that had taken place around 1980 allowed the etiologic agent in
infected carcasses to survive, contaminate the protein supplement, and infect
cattle. There is strong evidence and widespread agreement that the outbreak was
amplified by feeding rendered bovine meat-and-bone meal to young calves. BSE has
a prolonged incubation period in cattle, ranging from two to eight years, with a
mean of five to six years.
Outside of the U.K., 22 other countries, mostly in Europe, have reported
cases of BSE in indigenous cattle to the World Organisation for Animal Health
(known as the O.I.E.). Other countries may be considered at risk because of an
inadequate surveillance program, a lack of information on which to make a risk
assessment, or the potential for exposure to BSE.
RELATED DISEASES
TSEs also include “scrapie” in sheep and goats, “chronic wasting disease”
(CWD) in deer and elk, feline spongiform encephalopathy, transmissible mink
encephalopathy, and, in humans, kuru, Gerstmann-Straussler-Scheinker syndrome,
fatal familial insomnia, and Creutzfeldt-Jakob disease (CJD or “classical” CJD)
and variant CJD, which was first reported in the U.K. in 1996. TSEs are not
known to infect non-mammalian species.
Classic CJD occurs throughout the world, including the U.S., at a rate of
about one case per million people. The median age at death in the U.S. of
patients with classic CJD is 68. Most cases of CJD are considered sporadic, a
small number are familial associated with a gene mutation, and a small number
are iatrogenic, resulting from the accidental transmission of the causative
agent via contaminated surgical equipment, or as a result of cornea or dura
mater transplants, or the administration of human-derived pituitary growth
hormones.
Variant CJD (vCJD) is a distinct variant from classic CJD and is strongly
believed to have been acquired from eating food products containing the BSE
agent. The absence of confirmed cases of vCJD in geographic areas free of BSE
supports this conclusion, and the interval between the period for initial
extended exposure of the population to potentially BSE-contaminated food and the
onset of initial vCJD cases, approximately ten years, is consistent with known
incubation periods for CJD. Experimental studies on monkeys and mice, as well as
additional laboratory studies of infecting prions from vCJD patients and
BSE-infected animals, also support such a relationship. The incubation period
for vCJD in humans is unknown, but is at least five years and could extend up to
20 years or longer.
As of December 1, 2003, a total of 153 vCJD cases had been reported
worldwide, 143 of the cases occurring in the U.K. The low number of vCJD cases
relative to the number of cases of BSE in the U.K. indicates that a substantial
species barrier protects humans from widespread illness. There are no cases of
vCJD having been contracted in the U.S. The only person diagnosed with vCJD
while living in the U.S. is a U.K. citizen believed to have acquired the disease
while living in the U.K.
LEGAL AND REGULATORY FRAMEWORK FOR FDA PROTECTIONS
FDA has a longstanding commitment to protecting consumers from BSE by
following multiple measures designed to safeguard FDA-regulated products from
possible contamination by the BSE agent. Under the FD&C Act, FDA has the
authority to prevent the adulteration and misbranding of FDA-regulated products.
For example, FDA has used provisions in Section 402(a) (the food adulteration
provisions) and Section 403(a) (the food misbranding provisions) of the FD&C
Act to prohibit ruminant feed from containing certain protein derived from
mammalian tissues. These same adulteration and misbranding provisions apply to
human food. Further, for medical products that require pre-market approval
(e.g., drugs under Section 505 and medical devices under Section 513 of the
FD&C Act), FDA has addressed safety concerns related to BSE through
requirements of the application and approval process. Additionally, when
material from the one BSE-positive cow in the U.S. was traced to renderers, FDA
advised those firms that this material could not be used as an animal feed
because it was adulterated under Section 402(a)(5) of the FD&C Act because
it was, in part, the product of a diseased animal. Under section 801 of the
FD&C Act, FDA may refuse admission of imported food and certain other
products that appear to be in violation of the FD&C Act. Furthermore, under
Section 701(a), FDA may promulgate regulations for the efficient enforcement of
the FD&C Act. For example, under Section 701(a) and other sections, FDA
promulgated its “animal feed” rule (Title 21, Code of Federal Regulation (CFR)
section 589.2000) to prohibit ruminant feed from containing certain protein
derived from mammalian tissues. In addition, under the Public Health Service
Act, FDA is authorized to make and enforce regulations to prevent the
introduction, transmission, or spread of communicable diseases from foreign
countries into the U.S. or between states.
PREVENTING THE SPREAD OF BSE: FDA PROTECTIONS
FDA and other Federal agencies have had preventive measures in place to
reduce the U.S. consumer’s risk of exposure to any BSE-contaminated meat and
food products for a considerable time. Since 1989, USDA has prohibited the
importation of live animals and animal products from BSE-at risk countries.
Since 1997, FDA has prohibited the use of certain mammalian proteins in the
manufacture of ruminant feed. FDA continues to implement policies to keep safe
all FDA-regulated products, including food, food ingredients, dietary
supplements, drugs, vaccines, and cosmetics from risk of any BSE-contaminated
bovine material. As a result of these multiple regulatory safeguards, the risk
of exposure to the BSE agent through products FDA regulates remains extremely
low in the U.S. In 1998, USDA commissioned the Harvard Center for Risk Analysis
to conduct an analysis and evaluation of the U.S. regulatory measures to prevent
the spread of BSE in the U.S. and to reduce the potential exposure of U.S.
consumers to BSE. The Harvard study concluded, among other things, that even if
introduced in the U.S., due to the preventive measures currently in place in the
U.S., BSE is extremely unlikely to become established in the U.S.
The U.S. employs a robust approach to preventing the introduction and
amplification of BSE, and the prevention of introduction and amplification of
BSE has been described as consisting of five separate firewalls. Our existing
firewalls are based on a four-pronged regulatory strategy:
Our first firewall is formed through regulations and enforcement to protect
U.S. borders from potentially infective materials utilizing a regime of import
controls. USDA, beginning in 1989, enacted major restrictions on imports, and
more restrictive import controls have been introduced as we have learned more
about the science of BSE and as the worldwide epidemiology has changed. FDA
remains a committed partner with USDA and CBP in protecting our borders. The
second firewall is surveillance of the U.S. cattle population for the presence
of BSE. Surveillance of the cattle population is the primary responsibility of
USDA, and USDA has recently announced steps to increase surveillance. The third
firewall is prevention of the amplification of BSE through feed provided to
cattle and other ruminants, and this responsibility falls primarily on FDA.
FDA’s animal feed ban regulations form the basis of this third firewall and have
been cited as one of the most significant elements needed to prevent the spread
of BSE in the U.S. We have taken intensive steps to get an extremely high level
of compliance with this feed ban. As a result, we have been able to work with
the animal feed industry to achieve more than a 99% compliance rate – and we
intend to continue to work for full compliance. The fourth firewall is making
sure that no bovine materials that can transmit BSE be consumed by people. So
even if a BSE-positive cow made it through all of the previous firewalls, which
is extremely unlikely, it would not pose any risk to people. USDA and FDA have
long had steps in place to help prevent any possible exposure to BSE in bovine
products, and recently USDA announced additional major steps to prevent any of
the tissues known to carry BSE from entering the beef supply, as well as to
restrict use of certain “downer” cows that might be at higher risk of carrying
BSE. FDA will be taking comparable measures to prevent human exposure to the
FDA-regulated bovine products that might potentially harbor BSE. A fifth
firewall is effective response planning to contain the potential for any damage
from a BSE positive animal, if one is discovered at some point in the system.
This urgent response plan went into place immediately upon the discovery of a
BSE-positive cow in Washington State on December 23, 2003. We have inspected and
traced products at 22 facilities, including feed mills, farms, dairy farms, calf
feeder lots, slaughterhouses, meat processors, transfer stations, and shipping
terminals. We have accounted for all the products related to the BSE-positive
cow that FDA regulates, and none have gone into human or animal consumption.
Moreover, FDA has conducted inspections at all the rendering facilities
involved, and found they were fully in compliance with our feed rule. The goal
of our firewall after firewall approach is to provide full protection of the
public against BSE without adding unnecessary costs or restricting the
consumption of safe beef products. FDA and USDA intend to maintain an extremely
high level of compliance with each firewall. In addition, our multi-layered
approach makes sure that even if each firewall doesn’t function perfectly, the
U.S. consumer is, nonetheless, protected from exposure to the BSE infective
material.
FDA's FEED RULE: SUBSTANCES PROHIBITED FROM USE IN ANIMAL FEED
Rendered feed ingredients contaminated with the BSE agent are believed to
be the principal means by which BSE is amplified in cattle populations. To help
prevent the establishment and spread of BSE through feed in the U.S., FDA
implemented a final rule that prohibits the use of most mammalian protein in the
manufacture of animal feeds for ruminants. This rule, 21 CFR 589.200, became
effective on August 4, 1997. Mammalian proteins exempted from the rule are blood
and blood products, gelatin, inspected meat products that have been cooked and
offered for human food and further heat processed for feed (such as plate waste
and used cellulosic food casings), milk products (milk and milk proteins), and
any product whose only mammalian protein consists entirely of porcine or equine
protein. Fats and oils, such as tallow, do not fall within the current feed rule
because they are not protein.
FDA implemented this rule to establish in our country feeding practices
consistent with the best science and epidemiological knowledge known at the time
to prevent the spread of BSE throughout herds of U.S. cattle. A risk assessment
sponsored by USDA and conducted by the Harvard Center for Risk Analysis,
released in November 2001, identified FDA’s feed ban as one of the primary
safeguards against the spread of BSE in U.S. cattle.
To maximize protection afforded by the feed regulation, FDA has developed
and implemented a BSE/Ruminant Feed Ban Inspection compliance program and
established the goal of 100 percent compliance. FDA’s strategy for achieving
uniform compliance with the feed rule focuses on three areas: education,
inspection, and enforcement.
A strong inspection presence can be considered the backbone of FDA’s
strategy for achieving compliance with the feed rule. FDA and its state
counterparts conduct, at least annually, targeted BSE inspections of 100 percent
of known renderers, protein blenders, and feed mills processing products
containing material prohibited from use in ruminant feed. Compliance by these
establishments with FDA’s 1997 feed rule is over 99 percent. FDA has prioritized
the inspection process so that any firms found to be out of compliance in their
last inspection will be promptly re-inspected. In addition, FDA will conduct
for-cause inspections where evidence dictates, e.g., as a result of a sampling
assignment. FDA and the states also conduct inspections of selected processors
that are not using prohibited material to ensure compliance with the regulation
by this segment of the industry.
Inspections conducted by FDA or state investigators are classified to
reflect the compliance status at the time of the inspection based upon the
objectionable conditions documented. These inspection decisions are reported as
OAI, Voluntary Action Indicated (VAI), or No Action Indicated (NAI).
An OAI inspection classification occurs when significant objectionable
conditions or practices were found and regulatory sanctions are warranted in
order to address the establishment’s lack of compliance with the regulation. An
example of an OAI inspection classification would be findings of manufacturing
procedures insufficient to ensure that ruminant feed is not contaminated with
prohibited material. Inspections classified with OAI violations will be promptly
re-inspected following the regulatory sanctions to determine whether adequate
corrective actions have been implemented. A VAI inspection classification occurs
when objectionable conditions or practices were found that do not meet the
threshold of regulatory significance, but do warrant advisory actions to inform
the establishment of findings that should be voluntarily corrected. Inspections
classified with VAI violations are more technical violations of the ruminant
feed rule such as minor record-keeping lapses and conditions involving
non-ruminant feeds. A NAI inspection classification occurs when no objectionable
conditions or practices were found during the inspection or the significance of
the documented objectionable conditions found does not justify further actions.
As of December 20, 2003, FDA had received over 26,000 inspection reports (6,404
for fiscal year 2003). The majority of these inspections (around 70 percent)
were conducted by state officials for FDA, with the remainder conducted by FDA
officials. The total number of inspection reports represents 13,672 firms, 1,949
of which are active and handle materials prohibited from use in ruminant feed.
These firms, which may be in more than one category, include renderers, licensed
feed mills, feed mills not licensed by FDA, protein blenders, and others (such
as ruminant feeders, on-farm mixers, pet food manufacturers, animal feed
salvagers, distributors, retailers, and animal feed transporters). The 1,949
active firms that handle prohibited material have been inspected by FDA and, as
of December 31, 2003, only five were found to have significant violations,
resulting in OAI. FDA is working with these firms to bring them into
compliance.
To be transparent about inspection results, FDA has recorded inspectional
findings in a newly designed FDA BSE/Ruminant Feed Inspection Database available
on FDA’s website. The database is dynamic, with new information being entered on
a continual basis. Each entry in the database represents the results of the most
recent inspection.
FDA also conducts sampling of feed and feed ingredients in the marketplace
as an additional tool to target firms for inspection. This type of sample
analysis is being done using feed microscopy as the method for detecting
prohibited materials. Other methods, such as polymerase chain reaction (PCR),
are being validated for additional analytical use.
Enforcement is an important component of the compliance strategy. FDA
pursues enforcement actions when we find knowing or intentional non-compliance,
or if repeated inspection and educational efforts are ineffective in assuring
compliance. Our first action of choice will ordinarily be a Warning Letter,
which notifies responsible parties of a violation or violations and asks for a
response within a certain time frame explaining corrective actions taken. When
it is consistent with the public protection responsibilities of FDA and the
nature of the violation, it is our practice to afford individuals and firms an
opportunity voluntarily to take appropriate and prompt corrective action. The
Agency has additional, more stringent enforcement tools available when our
notification to the company of documented violations does not lead to compliance
with the FD&C Act, including product seizure, injunction, and
prosecution.
As of January 1, 2004, FDA has issued 63 Warning Letters and has one court
ordered Permanent Injunction since the BSE feed rule went into effect. Also, 47
firms recalled 280 products during the same time period; 12 of the recalls were
in 2003.
Education has been, and continues to be, a critical component of our
compliance strategy. Providing clear guidance and information on FDA’s
requirements and regulations is vital to help assure compliance. FDA has
provided and sponsored many educational services and forums, including
nationwide seminars, CD-ROM training, teleconferences, guidances targeted for
different segments of the animal feed industry, guidance for Federal and state
inspectors, and a variety of published articles. The Agency has met with many
industry trade groups to discuss coordination of educational efforts with
affected parties, and we expect to continue an open dialogue, seeking
suggestions for types of educational approaches, sharing resources, and keeping
the industry updated on new developments or problem areas that arise.
IMPORT CONTROLS
To minimize the risk of the introduction or spread of BSE we also must have
strong enforcement measures to protect our borders. FDA’s Import Program is
responsible for coordinating the import of products potentially infected with or
at high risk of infection with the agent associated with BSE. Operationally,
FDA’s Import Program provides for the review of information about FDA-regulated
products offered for entry into the U.S. and the opportunity for physical
examination of the products. FDA uses this information to determine whether a
product is subject to refusal of admission.
In protecting the borders from potentially unsafe products, FDA works
closely with USDA and CBP to ensure a coordinated and efficient BSE import
control strategy. This tri-agency cooperative effort has led to a multi-layer
review process whereby each agency utilizes the strengths of its particular
entry procedures to produce a composite system that is considerably more robust
than any one component. BSE import activities are reviewed and coordinated by an
inter-agency workgroup composed of representatives from FDA, CBP, and
USDA/APHIS. In fact, on February 5, 2002, with APHIS, FSIS, Canadian Food
Inspection Agency (CFIA), Health Canada, and state participation, FDA conducted
a simulation exercise involving the importation of potentially BSE-contaminated
product and subsequent regulatory follow-up.
FDA uses Import Alerts to disseminate information regarding problems or
potential problems with imported products. Import Alerts recommend that field
offices examine, sample, or detain and, if warranted, refuse admission of the
product in question. These Import Alerts are made available on FDA’s website.
With respect to its import alerts on BSE, FDA coordinates closely with APHIS and
its prohibitions on the importation of products related to BSE concerns. An
alert may cover an individual manufacturer, supplier, or a particular product
from an entire country. Import Alerts also may be issued as a follow-up to an
inspection, when it is determined that a manufacturer is in violation of good
manufacturing practice requirements.
FDA has in place several import alerts targeting BSE. Import Alert 17-04,
first issued in October 1994, allows detention, without physical examination, of
bulk shipments of high-risk bovine tissues and tissue-derived ingredients from
BSE-at-risk countries. Import Alert 99-25, first issued in January 2001, allows
detention without physical examination of animal feed, animal feed ingredients,
and other products for animal use from countries identified by USDA as
BSE-positive or BSE-at-risk when processed animal protein is declared in the
ingredients or when FDA sampling and analysis finds the presence of undeclared
animal protein. Import Alert 71-02, issued in October 2003, calls for detention
without physical examination of products of specific firms located in
USDA-listed BSE-positive or BSE-at-risk countries, which have been identified
through FDA sampling and analysis, as importing products containing animal
protein. These import alerts are continuously updated as new countries are
listed by USDA as either BSE-positive or BSE-at-risk, or to make other
appropriate changes.
FDA's RESPONSE TO THE IDENTIFICATION OF A BSE-POSITIVE COW IN WASHINGTON
STATE
On December 23, 2003, at approximately 3:00 pm, the Agency’s Office of
Crisis Management (OCM) was notified by USDA’s APHIS of a presumptive-positive
finding of bovine spongiform encephalopathy (BSE) in a “downer” cow slaughtered
on December 9, 2003, at a USDA-inspected slaughter facility in Washington
State.
FDA had in place its Bovine Spongiform Encephalopathy Emergency Response
Plan that describes the roles and activities of each of the Agency components
involved in managing this kind of emergency. This plan had been tested several
times in tabletop and simulated incidents that actively involved state, Federal,
and Canadian counterparts. The plan has been in place since 2001 and has been
revised in response to the incident exercises conducted by FDA.
As provided in the Emergency Response Plan, OCM’s Emergency Operations
Center (EOC) is the single point of coordination for FDA’s response to a BSE
emergency. FDA’s EOC maintains contact with HHS Secretary’s Command Center
(SCC), CDC’s EOC, USDA/FSIS Office of Food Security and Emergency Preparedness,
and other EOCs, as appropriate.
At the time of notification by USDA of the presumptive case of BSE, FDA’s
OCM initiated its BSE Emergency Response Plan and activated FDA’s EOC. Various
FDA headquarters and FDA center offices were immediately notified in accordance
with the plan, as well as the FDA Seattle District Office (SEA-DO).
FDA responsibilities include conducting inspections and investigations to
determine where any animal by-products went and ensuring that they did not enter
commerce contrary to provisions of the FD&C Act and other statutes enforced
by FDA.
On the same day FDA was notified of the presumptive case of BSE by USDA,
FDA’s SEA-DO dispatched five investigative teams to investigate various
facilities suspected of being either a source or recipient of affected
material.
An aggressive schedule of inspections and investigations was pursued by FDA
which enabled FDA to announce in December 27, 2003, that its investigators and
inspectors from the states of Washington and Oregon had located the high risk
material rendered from the one cow that had tested positive for BSE in
Washington State and that the rendering plants that processed this material had
placed a hold on the rendered material. The firms, located in Washington State
and Oregon, assisted and cooperated fully with FDA’s investigation.
FDA advised the involved renderers on acceptable methods of disposing of
material, such as landfill (coordinating with state and local officials and
EPA), incineration, digestion, or conversion to a fuel/industrial source.
Disposal of the meat and bone meal on hold has begun.
Communications, of course, have played a critical role in many aspects of
the incident response. Late on December 23, 2003, FDA’s headquarters and
district staff participated in a teleconference with APHIS and Washington State
officials to ensure a coordinated response to the incident. FDA, CDC, Department
of Defense, and FSIS continued to participate in APHIS-initiated interagency
calls throughout the response to the incident.
FDA also has kept affected industries and State counterparts informed and
up-to-date. On December 23, 2003, FDA’s Center for Food Safety and Applied
Nutrition (CFSAN) advised Washington State milk cooperatives that there was no
known risk of BSE transmission from milk. The scientific data indicate that milk
from BSE cows does not transmit BSE.
In responding to the BSE incident, FDA inspected and traced products at
many different facilities, including renderers, feed mills, farms, dairy farms,
calf feeder lots, slaughterhouses, meat processors, transfer stations, and
shipping terminals. Notably, inspectors found no deviations from FDA’s feed
rule.
WORKING WITH FOREIGN GOVERNMENTS
FDA officials regularly meet with representatives of foreign governments
and international organizations on many levels and on many issues of common
interest, including BSE. Immediately after the announcement on December 23,
2003, of a BSE-positive cow in the U.S., various foreign governments closed
their markets to U.S. beef. Since that time, FDA officials, working closely with
USDA officials, have been involved in numerous meetings and consultations with
representatives of foreign governments to help address concerns and restore
confidence in American products. For example:
FDA representatives met with Japanese officials from the Ministry of
Agriculture, Forestry, and Fisheries, the Ministry of Health, Labor, and
Welfare, the Food Safety Commission and the Japanese Embassy on January 9, 2004,
to discuss BSE control measures in animal feed and food additives. FDA
representatives met with numerous foreign attaches at USDA on January 12, 2004,
to discuss FDA’s Center for Veterinary Medicine measures to prevent BSE in
animal feeds. FDA representatives met in separate meetings on January 13, 2004,
with officials from the CFIA and from Mexico’s SecretarÃa de Agricultura,
GanaderÃa, Desarrollo Rural, Pesca y Alimentación to discuss current feed safety
measures to prevent BSE in the U.S. The Ministers of Agriculture of the U.S.,
Mexico and Canada met on January 16, 2004, to coordinate ongoing interagency
efforts towards expediting increased harmonization through a consultative
process among the countries. I accompanied Secretary of Health and Human
Services Tommy G. Thompson, at this meeting that resulted in a proposal to
establish a Coordinating Committee on BSE to facilitate collaborative effort.
Additionally, last week I visited with Japanese and Korean officials, as part of
the U.S. Government’s delegation to discuss scientific and trade implications of
the U.S. BSE case. The delegation also included senior scientific, regulatory,
and trade officials from USDA, and the U.S. Trade Representative. RESEARCH
Several of FDA’s Centers, as well as many private laboratories, academic
institutions, and other Federal Agencies (most notably NIH) are involved in
significant research activities relating to TSEs. Basic areas requiring research
include: increasing our understanding of prions; learning how prions are
transmitted within a species and potentially between species; developing
diagnostic tests for humans and animals; developing detection methods for use on
regulated products; developing methods to increase or eliminate infectivity; and
designing new treatments.
Most people envision research as being applied by medical practitioners to
diagnose and treat disease. Applied research also is critical in a regulatory
environment, where knowledge and tools gained through applied research can help
us to achieve our mission more effectively and more efficiently.
Taking one example pertinent to BSE, current rendering processes do not
completely inactivate the BSE agent. Advances in technology that could
distinguish between BSE-infected and non-infected cattle, or that could
completely inactivate the BSE agent in feed components may allow for exemptions
to the feed regulations for those renderers and feed manufactures who apply
these technologies.
Discussed below some examples of research on BSE and vCJD that could have
significant regulatory implications and benefit:
FDA’s CFSAN is in the final year of funding a two-year project to develop
sensors to detect abnormal prion protein in food. Work on the project should be
completed in early 2004, and will result in a report on the usefulness of the
sensors for detecting TSE agents in finished food products. No tests for the
rapid diagnosis of vCJD have been validated as either sufficiently specific or
sensitive to be used to screen the blood supply. A reliable blood-screening test
for vCJD is an extremely important goal and is currently the object of
considerable research activity. FDA has conducted and supported research efforts
in the process of validating a rapid-DNA based method for detection of animal
derived materials in animal feed and feed ingredients. As a part of this
research effort, FDA has developed a Polymerase Chain Reaction probe to
determine the animal species of origin from which feed ingredients were derived.
FDA remains firmly committed to bringing better science to the public, to
provide better public health protection at a lower cost. That’s why a key part
of our BSE strategy involves fostering the development of better technologies to
deal with BSE. To enhance the ability of our public health system to detect
prohibited materials in animal feed, FDA will continue to support the
development and testing of diagnostic tests to identify prohibited materials. As
these tests are developed FDA will evaluate the utility of such tests promptly
and thoroughly, so that there will be a quick and reliable method of testing
animal feeds for prohibited materials.
ADDITIONAL MEASURES TO BOLSTER PROTECTIONS AGAINST BSE
FDA implemented the feed rule in 1997 based on the best information
obtainable on the science and epidemiology of BSE at the time. The Agency also
recognized that evolving, complex scientific and public health issues,
particularly regarding BSE and vCJD, required the Agency to continue to assess
and scrutinize the rule to ensure its integrity as a firewall against the
potential for spread of BSE.
The Agency held a public hearing in October 2001 to solicit information and
views on its present animal feed regulation. FDA requested information and views
from individuals and organizations on the present rule and whether changes in
the rule or other additional measures were necessary. The Agency was
particularly interested in soliciting comments and views from individuals,
industry, consumer groups, health professionals, and researchers with expertise
in BSE and related animal and human diseases. The Agency specifically invited
comments, both oral and written, on 17 questions about ways the rule and its
enforcement might be improved to achieve its original objectives of preventing
the establishment and amplification of BSE in the U.S. Transcripts of the
hearing were then made publicly available with access through FDA’s
website.
Soon after the public hearing, the USDA released the Harvard Center for
Risk Analysis’s findings on the impact of various risks and potential pathways
for exposure of U.S. cattle and U.S. citizens to the BSE agent. This assessment
of the situation in the United States concluded that, due to control measures
already in place, the risk to U.S. cattle and to U.S. consumers from BSE is very
low. The model also demonstrated that certain new control measures could reduce
the small risk even further.
To further explore ways the animal feed regulation could be improved in
November 2002, FDA published an ANPR soliciting information and views from the
affected industries and the public on some potential changes to its current feed
regulation, including ways that the animal feed regulation could be
strengthened. Information and comments were sought on the following five aspects
of the BSE feed regulation: feasibility and impacts of excluding high risk
materials, such as brain and spinal cord, from rendered animal products; use of
poultry litter in cattle feed and impacts of banning such use; impacts of
introducing new labeling requirements for pet food; methods to prevent
cross-contamination between prohibited and non-prohibited material; use of plate
waste in ruminant feed and impacts of eliminating such use.
Yesterday, we announced that we will be taking several additional steps to
further strengthen the current robust safeguards that help protect Americans
from exposure to the agent that causes BSE and help prevent the spread of BSE in
U.S. cattle. These measures relate to both protections for foods intended for
human consumption as well as additional measures to strengthen FDA’s 1997 final
rule regulating animal feed. Many of these steps were raised in the November
2002, ANPR, as well as at the public meeting. With respect to human foods the
Agency announced it will be extending to FDA-regulated foods, dietary
supplements and cosmetics, restrictions on using specified risk materials that
would complement the recent USDA announcements. Concerning animal feed, the
Agency announced a series of measures designed to lower even further the risk
that cattle will be purposefully or inadvertently fed “ruminant” proteins,
including, eliminating the existing exemption in the feed rule that allows
mammalian blood and blood products at slaughter to be fed to ruminants as a
protein source; prohibiting the use of “poultry litter” as a feed ingredient for
cattle and other ruminants; banning the use of “plate waste” as a feed
ingredient for ruminants, including cattle; taking further steps to minimize the
possibility of cross-contamination of animal feed via equipment, facilities or
production lines; and evaluating additional mechanisms to enhance the ability of
our public health system to detect prohibited materials in animal feed utilizing
diagnostic tests.
In addition, FDA intends step up its inspections of feed mills and
renderers in 2004. FDA is increasing its inspections of feed mills and renderers
in 2004. Our 2001 base funding for BSE-related activities was $3.8 million. We
shifted resources internally in 2001 and received a substantial increase from
Congress in 2002. Our funded level for 2004 is currently approximately $21.5
million, almost a five-fold increase over the 2001 base. FDA will itself conduct
2,800 inspections and will make its resources go even further by working with
state agencies to fund 3,100 contract inspections of feed mills and renderers
and other firms that handle animal feed and feed ingredients. Through
partnerships with states, FDA will also receive data on 700 additional
inspections, for a total of 3,800 state contract and partnership inspections in
2004. These inspections would include 100 percent of all known renderers and
feed mills that process products containing prohibited materials.
CONCLUSION
FDA has an enormous responsibility in assuring that the products the Agency
regulates which contain bovine materials are safe and uncompromised by BSE or
other TSEs. FDA’s principal line of defense in meeting this responsibility is to
cut-off all avenues for the possible spread of BSE through U.S. cattle herds.
Our most powerful tool in preventing the spread of BSE in U.S. cattle herds is
effective enforcement of the Agency’s feed ban restrictions as part of a
multi-layered set of firewalls put in place as part of the U.S. Government’s
comprehensive BSE prevention program. To date, a rigorous program of education,
inspections, and enforcement education have enabled us to fulfill our
responsibilities as part of the U.S. plan for preventing the spread of BSE.
Although the risk of exposure to BSE in the United States remains extremely low
and the measures in place are working, as a result of the recently discovered
infected cow in the state of Washington, the Agency will be taking additional
science-based steps to further strengthen our current protections.
FDA looks forward to continuing to assist Congress as it evaluates the
risks associated with BSE, identifies opportunities to promote technologies that
will detect and prevent the spread of BSE, and considers science-based
approaches to further strengthen regulatory protections and bolster the
resources available to assure that BSE does not present a threat to human or
animal health in the U.S.
Thank you for the opportunity to testify today.
Dr. Crawford discussed FDA’s efforts to prevent the establishment and
spread of TSEs, including the firewalls in place, and FDA’s recent announcement
of actions it intends to take to further ensure the safety of animal feed and
consumer products regulated by FDA. Concerning animal feed, the Agency announced
a series of measures designed to lower the risk that cattle will be purposefully
or inadvertently fed “ruminant” proteins. These measures included eliminating an
exemption in the feed rule that allows mammalian blood and blood products to be
fed to ruminants as a protein source; banning the use of “poultry litter” as a
feed ingredient for cattle and other ruminants; prohibiting the use of “plate
waste” as a feed ingredient for ruminants, including cattle; and taking steps to
further minimize the possibility of cross-contamination of animal feed via
equipment, facilities or production lines.
never happened...2013...TSS
*** BUT, this did happen, Lester M. Crawford was charged Monday with
criminal violations stemming from his failure to tell government ethics officers
that he owned stock in companies regulated by the FDA ***
FEATURED ARTICLES
NATIONAL
Ex-FDA Chief Charged With Stock Conflict October 17, 2006 | Ricardo
Alonso-Zaldivar, Times Staff Writer
Former Food and Drug Administration Commissioner Lester M. Crawford was
charged Monday with criminal violations stemming from his failure to tell
government ethics officers that he owned stock in companies regulated by the
FDA. His lawyer said Crawford intended to plead guilty to two misdemeanor
charges during a federal court hearing this afternoon. "He accepts
responsibility," said attorney Barbara Van Gelder. "It really was an oversight.
ARTICLES BY DATE NATIONAL Ex-FDA chief gets fines, probation February 28,
2007 | From Times Wire Reports
A judge sentenced former Food and Drug Administration chief Lester M.
Crawford to three years' supervised probation with fines of almost $90,000 for
lying about stocks he owned in companies regulated by his agency. Magistrate
Judge Deborah A. Robinson also ordered Crawford to perform 50 hours of community
service. Crawford, 69, pleaded guilty in October.
no conflict of interest there, right...
USDA INC. in my opinion.
now, let’s look at what really happened, and where we stand now in regards
to the BSE TSE prion disease in the USDA, and danged I would sure like to know
(in the old fda mad cow feed ban warning letter layman term for dummies), what
the OIA in 2011, 2012, and 2013 were all about ???
=========================================
BSE TSE PRION USDA FDA MAD COW FEED COMPLIANCE REPORT and NAI, OAI, and VAI
ratings as at June 5, 2013, as follows ;
FDA District Firm ID (FEI) Firm Name Street Address City State Zip Code
Opr. Status Firm Type(s) Prgm Risk Last BSE Insp Date **Last BSE Dist Dcsn
Handles Fee for Rum. Animals
4018 CHI-DO 3007091297 Rancho Cantera 2866 N Sunnyside Rd Kent IL
61044-9605 OPR FR, OF HP 11/26/2012 OAI Y
9367 3008575486 Rocky Ford Pet Foods 21693 Highway 50 East Rocky Ford CO
81067 OPR RE, TH HP 2/27/2013 OAI N
9446 DEN-DO 1713202 Weld County Bi Products, Inc. 1138 N 11th Ave Greeley
CO 80631-9501 OPR RE, TH HP 10/12/2012 OAI N
9447 DEN-DO 3002857110 Weld County Bi-Products dba Fort Morgan Pet Foods
13553 County Road 19 Fort Morgan CO 80701-7506 OPR RE HP 12/7/2011 OAI N
9789 DET-DO 1813774 Belstra Milling Co. Inc. 424 15th St Se Demotte IN
46310-9367 OPR DR, FL, TH DP 1/11/2011 VAI Y
9976 Hagerstown DET-DO 3000215300 Maxwell Milling of Indiana, Inc. 4359 N
State Road 1 Hagerstown IN 47346-9620 OPR FL, TH NP 9/12/2012 VAI N
9983 Evansville DET-DO 1833240 Midwestern Pet Foods, Inc. 9634 Hedden Rd
Evansville IN 47725-9660 OPR DR, NL, PF, TH HP 1/14/2013 VAI N
10316 Grant MI 49327-8982 OPR OT NP 10/17/2006 VAI N
10401 DET-DO 1880511 Kuber'S Feed Mill 912 41st Ave Menominee MI
49858-1322 OPR DR, NL DP 1/16/2013 VAI Y
10430 Osseo MI 49266-9847 OPR DR, NL, TH NP 12/20/2011 VAI Y
10471 Sebewaing MI 48759-9701 OPR DR, HF, NL NP 7/25/2011 VAI Y
10480 Millington MI 48746 OPR DR, NL, TH DP 1/20/2011 VAI Y
10483 Morley MI 49336-9097 OPR FR, OF NP 1/11/2012 VAI Y
10501 Hart MI 49420-1129 OPR DR, OT DP 6/14/2011 VAI Y
10520 Battle Creek MI 49015-4283 OPR OT NP 2/18/2004 VAI N
10536 Reed City MI 49677-1001 OPR DR, NL DP 9/9/2010 VAI Y
10555 Montague MI 49437-9436 OPR DR DP 3/3/2010 VAI Y
10640 Blissfield MI 49228-9529 OPR DR, FL, HF, PF HP 3/27/2013 VAI Y
10846 New Smyrna Beach FL 32168-9155 OPR FR NP 9/7/2006 VAI Y
10968 Thonotosassa FL 33592-3353 OPR RO NP 11/3/2005 VAI Y
11261 Groveland FL 34736-2509 OPR AF, DR DP 1/11/2005 VAI N
11318 Plant City FL 33567-3002 OPR RO DP 1/26/2006 VAI Y
11479 St Petersburg FL 33709-2304 OPR AF, DR DP 6/17/2004 VAI N
11655 Lake Butler FL 32054 OPR AF, DR, FR, NL, OF DP 12/1/2009 VAI Y
11851 Plant City FL 33565-3736 OPR FR NP 10/25/2007 VAI Y
11866 Jupiter FL 33478-6686 OPR FR NP 10/5/2007 VAI Y
12090 Summerfield FL 34491-4930 OPR OT, RE NP 3/6/2012 VAI N
12445 Lakeland FL 33815-3569 OPR AF, DR DP 7/29/2008 VAI N
12839 Sumterville FL 33585-5328 OPR FR NP 1/23/2004 VAI Y
13007 Okeechobee FL 34972 OPR DR, NL, TH NP 8/20/2010 VAI Y
13120 Ft. Macleod, Canada OPR 6/17/2010 VAI
13273 Winterset IA 50273 OPR DR, NL DP 1/23/2013 VAI Y
13359 Arion IA 51520-2034 OPR PB HP 4/4/2013 RTS Y
13360 Logan IA 51546 OPR TH DP 10/13/2009 VAI Y
13400 Farmersburg IA 52047-8064 OPR FR, OF NP 3/16/2012 VAI Y
13436 Ryan IA 52330-8549 OPR FR, OF HP 4/17/2008 VAI Y
13658 Wilton IA 52778-0001 OPR DR, NL DP 3/30/2011 VAI Y
13914 Lime Springs IA 52155-8246 OPR TH DP 4/11/2006 VAI Y
13976 Woodbine IA 51579-1504 OPR DR, OT NP 8/28/2008 VAI Y
14083 Luana IA 52156-8072 OPR FR, OF HP 6/10/2010 VAI Y
14540 Griswold IA 51535-6566 OPR OT NP 6/13/2012 VAI N
14632 Webster IA 52355 OPR OT HP 6/5/2012 VAI N
14679 Garnavillo IA 52049-8081 OPR FR, OF HP 9/11/2010 VAI Y
14842 Chelsea IA 52215-9714 OPR FR, OF HP 5/20/2010 VAI Y
14850 Rock Rapids IA 51246-7723 OPR FR, OF NP 10/19/2004 VAI Y
14888 Hawarden IA 51023-7590 OPR FR, OF NP 3/28/2005 VAI Y
14894 Grinnell IA 50112-8151 OPR DR, NL DP 12/6/2012 VAI Y
14993 Saint Olaf IA 52072-0047 OPR DR, NL DP 3/15/2011 VAI Y
15103 Des Moines IA 50313-4736 OPR DR, PF DP 2/21/2012 VAI N
15173 Villisca IA 50864-7007 OPR DR, NL, TH DP 1/23/2012 VAI Y
15258 Cascade IA 52033-0038 OPR DR, NL, TH DP 1/29/2013 VAI Y
15307 Volga IA 52077-8006 OPR FR, OF NP 6/12/2012 VAI Y
15359 Kiowa KS 67070-1801 INA TH DP 9/25/2008 VAI Y
15387 Colwich KS 67030-9723 OPR DR, FR, OT NP 8/22/2008 VAI Y
15747 Greenleaf KS 66943-9755 OPR OF, OT, TH HP 7/9/2012 VAI N
16172 Wichita KS 67219-3615 OPR TH DP 2/26/2009 VAI Y
16208 Wichita KS 67214-1406 OPR TH DP 7/6/2009 VAI Y
16393 Salina KS 67401-1702 OPR HF NP 4/20/2012 VAI Y
16444 Montezuma KS 67867-9111 OPR FR NP 4/17/2008 VAI Y
16859 Conway MO 65632-0159 OPR DR DP 11/27/2012 VAI Y
16927 Butler MO 64730-1341 OPR DR, NL, TH DP 12/15/2010 VAI Y
16930 Cole Camp MO 65325 OPR DR, NL, TH DP 1/9/2013 VAI Y
17305 Pilot Grove MO 65276-0171 OPR DR, NL, TH DP 3/7/2013 VAI Y
17383 Meta MO 65058-0156 OPR PF HP 6/5/2012 VAI N
17701 Wisner NE 68751 OPR FR NP 2/3/2005 VAI Y
17944 Aurora NE 68818-2320 OPR TH DP 6/21/2005 VAI Y
17977 Lexington NE 68850-2160 OPR OT NP 11/17/2010 VAI N
18183 Gering NE 69341-3726 OPR FL NP 6/28/2012 VAI Y
18677 Lincoln NE 68522 OPR FR HP 3/21/2011 VAI Y
18865 Mc Cook NE 69001-0148 OPR OT NP 12/28/2006 VAI Y
19248 Gilbert AZ 85295-1795 OPR DR DP 8/18/2011 VAI Y
19342 Casa Grande AZ 85222-4315 OPR DR DP 4/10/2012 VAI Y
19343 Glendale AZ 85301 OPR DR, PF HP 6/13/2011 VAI Y
19456 Yuma AZ 85365 OPR DR DP 8/20/2012 VAI Y
19469 Kingman AZ 86409-2655 OPR DR DP 7/11/2011 VAI Y
19475 Lakeview CA 92567-9062 OPR OF, OT HP 8/28/2006 VAI N
19502 City Of Industry CA 91746-3038 OPR DR DP 8/26/2009 VAI N
19503 City of Industry CA 91746-3037 SEA DR DP 8/26/2009 VAI N
19554 Perris CA 92570 OPR DR HP 8/25/2009 VAI Y
19586 Vernon CA 90058-1825 OPR HF HP 10/12/2009 VAI N
19645 San Pedro CA 90731-7429 OPR PF HP 1/22/2008 VAI N
19696 Nuevo CA 92585 OPR FR, OT HP 5/28/2009 VAI Y
19750 Pacoima CA 91331-2526 OPR OT, PF HP 5/3/2007 VAI N
19752 Compton CA 90221-5723 OPR TH HP 6/2/2010 VAI N
19836 Cudahy CA 90201-5816 OPR HF NP 1/27/2011 VAI N
19852 Murrieta CA 92562-6903 OPR OT HP 12/3/2009 VAI N
19855 Long Beach CA 90810 OPR OT, TH DP 8/13/2009 VAI N
19856 Long Beach CA 90810-1900 OPR OT DP 8/13/2009 VAI Y
19880 Beaumont CA 92223-2648 OPR DR, NL, OT, TH DP 2/15/2007 VAI Y
19933 Pacoima CA 91331-1605 OPR PF HP 11/14/2012 VAI N
19945 City of Industry CA 91789-2848 OPR DR DP 6/16/2008 VAI N
19999 Long Beach CA 90806-2425 OPR PF HP 1/6/2009 VAI N
20025 Nuevo CA 92567 OPR AF HP 5/28/2009 VAI Y
20068 Gardena CA 90248-2027 OPR OT DP 5/15/2006 VAI N
20122 Ontario CA 91761-8604 OPR OT NP 3/26/2008 VAI Y
20233 Minneapolis MN 55402 OPR DR, OT DP 6/1/2012 VAI Y
20236 Hector MN 55342 OPR DR, NL, TH HP 12/19/2012 VAI N
20250 Pine Island MN 55963 OPR FR HP 3/9/2010 VAI Y
20352 Altura MN 55910-4109 OPR DR, PF, RE, TH HP 3/1/2013 VAI N
20397 Kenyon MN 55946 OPR FR NP 3/10/2010 VAI Y
20881 Rochester MN 55904 OPR DR DP 1/16/2013 VAI N
20885 Menahga MN 56464 OPR FR HP 5/21/2012 VAI Y
20923 Fergus Falls MN 56537-2146 OPR OT, TH HP 4/2/2008 VAI N
21141 Forest Lake MN 55025-1559 OPR DR, NL, TH DP 5/1/2012 VAI Y
21395 Spring Grove MN 55974-3434 OPR FR, OF NP 6/10/2008 VAI Y
21409 Albany MN 56307-8717 OPR RO HP 7/14/2006 VAI Y
21470 Royalton MN 56373 OPR FR NP 10/26/2006 VAI Y
21471 Pierz MN 56364 OPR RO HP 7/18/2006 VAI Y
21690 Moose Lake MN 55767-7707 OPR AF, DR, NL, TH DP 9/27/2012 VAI Y
21706 Richmond MN 56368-8126 OPR FR NP 1/21/2010 VAI Y
21947 Waverly MN 56390 OPR FR NP 3/4/2010 VAI Y
21996 Inver Grove Heights MN 55077-5912 OPR DR DP 1/15/2013 VAI Y
22051 Perham MN 56573-8122 OPR FR NP 1/9/2008 VAI Y
22054 Pierz MN 56364-7143 OPR FR NP 6/9/2005 VAI Y
22378 New Ulm MN 56073-3468 OPR DR, NL, OT, TH HP 3/20/2013 VAI Y
22439 Slayton MN 56172-1820 OPR FR, OF NP 8/26/2010 VAI Y
22546 Morris MN 56267 OPR FR NP 1/15/2010 VAI Y
22631 Brownsdale MN 55918 OPR DR, NL, RE HP 12/17/2012 VAI N
22643 Holland MN 56139-4755 OPR FR, OF NP 6/13/2011 VAI Y
22649 Mora MN 55051-7107 OPR DR, NL, TH DP 3/26/2012 VAI Y
24763 Montfort WI 53569 OPR FR, OF NP 12/10/2004 VAI Y
24766 Bonduel WI 54107-8827 OPR FR NP 2/18/2000 VAI
25152 Random Lake WI 53075-1772 OPR DR, NL, TH DP 7/15/2011 VAI Y
25713 Kiel WI 53042-9747 OPR DR, NL, PB, TH DP 5/18/2012 VAI Y
26585 Rutland MA 01543- OPR FR NP 6/5/2006 VAI N
26631 Westmoreland NH 03467- OPR NP 12/12/2008 VAI
26637 Bristol VT 05443-5054 OPR FR NP 8/9/2011 VAI Y
26645 Sheldon VT 05483- OPR FR NP 11/20/2012 VAI Y
27308 Arkport NY 14807-9616 OPR FR HP 1/27/2009 VAI Y
27544 Clyde NY 14433-9543 OPR FR NP 2/21/2003 VAI Y
27743 Almond NY 14804-9635 OPR FR NP 6/17/2009 VAI Y
27840 Potsdam NY 13676-3328 OPR FR, OF NP 2/28/2002 VAI Y
27926 Cincinnatus NY 13040-9666 OPR FR NP 5/28/2012 VAI Y
27969 Java Center NY 14082-9630 OPR OF NP 8/17/2005 VAI Y
28033 Utica NY 13502-2920 OPR RE, TH HP 10/18/2012 VAI N
28119 Kennedy NY 14747-9571 OPR FR HP 4/6/2009 VAI Y
28124 Venice Center NY 13147-3187 OPR FR HP 9/3/2009 VAI Y
28263 Edmeston NY 13335 OPR FR NP 12/1/2011 VAI Y
28287 Clymer NY 14724-9625 OPR FR NP 6/24/2009 VAI Y
28666 Hatfield PA 19440-3614 OPR PF HP 9/22/2011 VAI N
29061 Claysburg PA 16625-8908 OPR DR, NL, OT, TH DP 12/4/2008 VAI Y
30380 Sacramento CA 95830-9498 OPR RE, TH HP 1/24/2013 VAI N
30382 Salinas CA 93901-4349 OPR RE NP 11/28/2011 VAI Y
30743 Waianae HI 96792-3523 OPR TH DP 8/23/2006 VAI Y
30748 Hauula HI 96717 OPR TH DP 8/22/2006 VAI N
30754 Kula HI 96790-7208 OPR DR DP 8/5/2006 VAI N
30755 Waianae HI 96792-3511 OPR TH DP 8/17/2006 VAI N
30815 Carson City NV 89706-1934 OPR OT DP 6/4/2003 VAI N
32233 Guaynabo PR 00767- OPR DR, NL, OT, PF NP 3/14/2013 VAI Y
32251 San Sebastian PR 00685- OPR FR NP 11/20/2012 VAI Y
Ruminant Feed Inspections Firms Inventory (excel format)
Tuesday, June 4, 2013
*** INTERPRETING RESULTS OF FSIS VERIFICATION SAMPLING OF DOMESTIC BEEF
PRODUCT DERIVED FROM ADVANCED MEAT RECOVERY SYSTEMS (AMR01/FAMR01) FSIS Notice
38-12
Thursday, May 30, 2013
*** World Organization for Animal Health (OIE) has upgraded the United
States' risk classification for mad cow disease to "negligible" from
"controlled", and risk further exposing the globe to the TSE prion mad cow type
disease
U.S. gets top mad-cow rating from international group and risk further
exposing the globe to the TSE prion mad cow type disease
Friday, May 24, 2013
Asynchronous Onset of Clinical Disease in BSE-Infected Macaques
Tuesday, May 21, 2013
Canada, USA, Bad feed, mad cows: Why we know three BSE cases had a common
origin and why the SSS policy is in full force $$$
Tuesday, May 7, 2013
Feds want five-year paper trail for livestock NAIS COOL
Tuesday, April 30, 2013
Foodborne Transmission of Bovine Spongiform Encephalopathy to Nonhuman
Primates
Friday, April 19, 2013
APHIS 2013 Stakeholder Meeting (March 2013) BSE TSE PRION
Tuesday, March 5, 2013
Use of Materials Derived From Cattle in Human Food and Cosmetics; Reopening
of the Comment Period FDA-2004-N-0188-0051 (TSS SUBMISSION)
FDA believes current regulation protects the public from BSE but reopens
comment period due to new studies
Wednesday, February 20, 2013
World Organization for Animal Health Recommends United States' BSE Risk
Status Be Upgraded
Statement from Agriculture Secretary Tom Vilsack:
Thursday, February 14, 2013
*** The Many Faces of Mad Cow Disease Bovine Spongiform Encephalopathy BSE
and TSE prion disease
Saturday, December 15, 2012
*** Bovine spongiform encephalopathy: the effect of oral exposure dose on
attack rate and incubation period in cattle -- an update 5 December 2012
2011 Monday, September 26, 2011
L-BSE BASE prion and atypical sporadic CJD
APHIS notes that for the current surveillance program, it had established
regional goals and APHIS was not trying to meet particular sampling levels in
particular States. However, we believe that it would be advantageous for APHIS
to monitor collection data and increase outreach when large geographical areas
such as the above States do not provide samples in proportion to the numbers and
types of cattle in the population.
We also disagree with APHIS/FSIS’ contention that because they have tested
over 375,000 of their 446,000 estimate of high risk cattle, few in the high-risk
population are being missed, including those that might be pre-screened before
entering a slaughter facility’s property. In our prior audit, we reported that
APHIS underestimated the high-risk population; we found that this estimate
should have been closer to 1 million animals (see Finding 1). We recognize that
BSE samples are provided on a voluntary basis; however, APHIS should consider
industry practice in any further maintenance surveillance effort. Animals
unsuitable for slaughter exhibiting symptoms not inconsistent with BSE should be
sampled and their clinical signs recorded. However, this cited industry practice
results in rejected animals not being made available to either APHIS or FSIS
veterinarians for their observation and identification of clinical signs
exhibited ante mortem. Although these animals may be sampled later at other
collection sites, the animals are provided post mortem without information as to
relevant clinical signs exhibited ante mortem. For these reasons, we believe
APHIS needs to
USDA/OIG-A/50601-10-KC Page 27
observe these animals ante mortem when possible to assure the animals from
the target population are ultimately sampled and the clinical signs
evaluated.
snip...
Subject: USDA OIG SEMIANNUAL REPORT TO CONGRESS FY 2007 1st Half (bogus BSE
sampling FROM HEALTHY USDA CATTLE)
Date: June 21, 2007 at 2:49 pm PST
Owner and Corporation Plead Guilty to Defrauding Bovine Spongiform
Encephalopathy (BSE) Surveillance Program
An Arizona meat processing company and its owner pled guilty in February
2007 to charges of theft of Government funds, mail fraud, and wire fraud. The
owner and his company defrauded the BSE Surveillance Program when they falsified
BSE Surveillance Data Collection Forms and then submitted payment requests to
USDA for the services. In addition to the targeted sample population (those
cattle that were more than 30 months old or had other risk factors for BSE), the
owner submitted to USDA, or caused to be submitted, BSE obex (brain stem)
samples from healthy USDA-inspected cattle. As a result, the owner fraudulently
received approximately $390,000. Sentencing is scheduledfor May 2007.
snip...
Topics that will be covered in ongoing or planned reviews under Goal 1
include:
soundness of BSE maintenance sampling (APHIS), implementation of
Performance-Based Inspection System enhancements for specified risk material
(SRM) violations and improved inspection controls over SRMs (FSIS and
APHIS),
snip...
The findings and recommendations from these efforts will be covered in
future semiannual reports as the relevant audits and investigations are
completed.
4 USDA OIG SEMIANNUAL REPORT TO CONGRESS FY 2007 1st Half
http://stanford.wellsphere.com/cjd-article/usda-certified-h-base-mad-cow-school-lunch-program/641216
Office of the United States Attorney District of Arizona
FOR IMMEDIATE RELEASE For Information Contact Public Affairs
February 16, 2007 WYN HORNBUCKLE Telephone: (602) 514-7625Cell: (602)
525-2681
CORPORATION AND ITS PRESIDENT PLEAD GUILTY TO DEFRAUDING GOVERNMENT’S MAD
COW DISEASESURVEILLANCE PROGRAM
snip...
Evidence uncovered during the government’s investigation established that
Farm Fresh Meats and Farabee submitted samples from cattle outside the Targeted
Cattle Population. Specifically, FarmFresh Meats and Farabee submitted, or
caused to be submitted, obex samples from healthy, USDA inspected cattle, in
order to steal government moneys.
Evidence collected also demonstrated that Farm Fresh Meats and Farabee
failed to maintain cattle carcasses and heads pending test results and falsified
corporate books and records to conceal their malfeasance. Such actions, to the
extent an obex sample tested positive (fortunately, none did), could have
jeopardized the USDA’s ability to identify the diseased animal and pinpoint its
place of origin.
snip...
Sentencing is set before Judge Earl H. Carroll on May 14, 2007. The
investigation in this case was conducted by Assistant Special Agent in Charge
Alejandro Quintero, United States Department ofAgriculture, Office of Inspector
General. The prosecutionis being handled by Robert Long, Assistant U.S.
Attorney, District ofArizona, Phoenix.CASE NUMBER: CR-07-00160-PHX-EHC RELEASE
NUMBER: 2007-051(Farabee)
# # #
Tuesday, November 02, 2010
BSE - ATYPICAL LESION DISTRIBUTION (RBSE 92-21367) statutory (obex only)
diagnostic criteria CVL 1992
BSE Case Associated with Prion Protein Gene Mutation (g-h-BSEalabama) and
VPSPr PRIONPATHY
*** (see mad cow feed in COMMERCE IN ALABAMA...TSS)
BANNED MAD COW FEED IN COMMERCE IN ALABAMA
Date: September 6, 2006 at 7:58 am PST PRODUCT
a) EVSRC Custom dairy feed, Recall # V-130-6;
b) Performance Chick Starter, Recall # V-131-6;
c) Performance Quail Grower, Recall # V-132-6;
d) Performance Pheasant Finisher, Recall # V-133-6.
CODE None RECALLING FIRM/MANUFACTURER Donaldson & Hasenbein/dba J&R
Feed Service, Inc., Cullman, AL, by telephone on June 23, 2006 and by letter
dated July 19, 2006. Firm initiated recall is complete.
REASON
Dairy and poultry feeds were possibly contaminated with ruminant based
protein.
VOLUME OF PRODUCT IN COMMERCE 477.72 tons
DISTRIBUTION AL
______________________________
PRODUCT Bulk custom dairy pre-mixes,
Recall # V-120-6 CODE None RECALLING FIRM/MANUFACTURER Ware Milling Inc.,
Houston, MS, by telephone on June 23, 2006. Firm initiated recall is complete.
REASON Possible contamination of dairy animal feeds with ruminant derived meat
and bone meal.
VOLUME OF PRODUCT IN COMMERCE 350 tons
DISTRIBUTION AL and MS
______________________________
PRODUCT
a) Tucker Milling, LLC Tm 32% Sinking Fish Grower, #2680-Pellet, 50 lb.
bags, Recall # V-121-6;
b) Tucker Milling, LLC #31120, Game Bird Breeder Pellet, 50 lb. bags,
Recall # V-122-6;
c) Tucker Milling, LLC #31232 Game Bird Grower, 50 lb. bags, Recall #
V-123-6;
d) Tucker Milling, LLC 31227-Crumble, Game Bird Starter, BMD Medicated, 50
lb bags, Recall # V-124-6;
e) Tucker Milling, LLC #31120, Game Bird Breeder, 50 lb bags, Recall #
V-125-6;
f) Tucker Milling, LLC #30230, 30 % Turkey Starter, 50 lb bags, Recall #
V-126-6;
g) Tucker Milling, LLC #30116, TM Broiler Finisher, 50 lb bags, Recall #
V-127-6
CODE All products manufactured from 02/01/2005 until 06/20/2006 RECALLING
FIRM/MANUFACTURER Recalling Firm: Tucker Milling LLC, Guntersville, AL, by
telephone and visit on June 20, 2006, and by letter on June 23, 2006.
Manufacturer: H. J. Baker and Brothers Inc., Stamford, CT. Firm initiated recall
is ongoing.
REASON Poultry and fish feeds which were possibly contaminated with
ruminant based protein were not labeled as "Do not feed to ruminants".
VOLUME OF PRODUCT IN COMMERCE 7,541-50 lb bags
DISTRIBUTION AL, GA, MS, and TN
END OF ENFORCEMENT REPORT FOR AUGUST 9, 2006
###
Subject: MAD COW FEED RECALL AL AND FL VOLUME OF PRODUCT IN COMMERCE 125
TONS Products manufactured from 02/01/2005 until 06/06/2006
Date: August 6, 2006 at 6:16 pm PST PRODUCT
a) CO-OP 32% Sinking Catfish, Recall # V-100-6;
b) Performance Sheep Pell W/Decox/A/N, medicated, net wt. 50 lbs, Recall #
V-101-6;
c) Pro 40% Swine Conc Meal -- 50 lb, Recall # V-102-6;
d) CO-OP 32% Sinking Catfish Food Medicated, Recall # V-103-6;
e) "Big Jim's" BBB Deer Ration, Big Buck Blend, Recall # V-104-6;
f) CO-OP 40% Hog Supplement Medicated Pelleted, Tylosin 100 grams/ton, 50
lb. bag, Recall # V-105-6;
g) Pig Starter Pell II, 18% W/MCDX Medicated 282020, Carbadox -- 0.0055%,
Recall # V-106-6;
h) CO-OP STARTER-GROWER CRUMBLES, Complete Feed for Chickens from Hatch to
20 Weeks, Medicated, Bacitracin Methylene Disalicylate, 25 and 50 Lbs, Recall #
V-107-6;
i) CO-OP LAYING PELLETS, Complete Feed for Laying Chickens, Recall #
108-6;
j) CO-OP LAYING CRUMBLES, Recall # V-109-6;
k) CO-OP QUAIL FLIGHT CONDITIONER MEDICATED, net wt 50 Lbs, Recall #
V-110-6;
l) CO-OP QUAIL STARTER MEDICATED, Net Wt. 50 Lbs, Recall # V-111-6;
m) CO-OP QUAIL GROWER MEDICATED, 50 Lbs, Recall # V-112-6 CODE
Product manufactured from 02/01/2005 until 06/06/2006
RECALLING FIRM/MANUFACTURER Alabama Farmers Cooperative, Inc., Decatur, AL,
by telephone, fax, email and visit on June 9, 2006. FDA initiated recall is
complete.
REASON Animal and fish feeds which were possibly contaminated with ruminant
based protein not labeled as "Do not feed to ruminants".
VOLUME OF PRODUCT IN COMMERCE 125 tons
DISTRIBUTION AL and FL
END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006
###
MAD COW FEED RECALL USA EQUALS 10,878.06 TONS NATIONWIDE Sun Jul 16, 2006
09:22 71.248.128.67
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
______________________________
PRODUCT
a) PRO-LAK, bulk weight, Protein Concentrate for Lactating Dairy Animals,
Recall # V-079-6;
b) ProAmino II, FOR PREFRESH AND LACTATING COWS, net weight 50lb (22.6 kg),
Recall # V-080-6;
c) PRO-PAK, MARINE & ANIMAL PROTEIN CONCENTRATE FOR USE IN ANIMAL FEED,
Recall # V-081-6;
d) Feather Meal, Recall # V-082-6 CODE
a) Bulk
b) None
c) Bulk
d) Bulk
RECALLING FIRM/MANUFACTURER H. J. Baker & Bro., Inc., Albertville, AL,
by telephone on June 15, 2006 and by press release on June 16, 2006. Firm
initiated recall is ongoing.
REASON
Possible contamination of animal feeds with ruminent derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE 10,878.06 tons
DISTRIBUTION Nationwide
END OF ENFORCEMENT REPORT FOR July 12, 2006
###
2007
10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. BLOOD LACED MBM IN
COMMERCE USA 2007
Date: March 21, 2007 at 2:27 pm PST
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINES -- CLASS II
PRODUCT
Bulk cattle feed made with recalled Darling's 85% Blood Meal, Flash Dried,
Recall # V-024-2007
CODE
Cattle feed delivered between 01/12/2007 and 01/26/2007
RECALLING FIRM/MANUFACTURER
Pfeiffer, Arno, Inc, Greenbush, WI. by conversation on February 5, 2007.
Firm initiated recall is ongoing.
REASON
Blood meal used to make cattle feed was recalled because it was cross-
contaminated with prohibited bovine meat and bone meal that had been
manufactured on common equipment and labeling did not bear cautionary BSE
statement.
VOLUME OF PRODUCT IN COMMERCE
42,090 lbs.
DISTRIBUTION
WI
___________________________________
PRODUCT
Custom dairy premix products:
MNM ALL PURPOSE Pellet, HILLSIDE/CDL Prot- Buffer Meal, LEE, M.-CLOSE UP PX
Pellet, HIGH DESERT/ GHC LACT Meal, TATARKA, M CUST PROT Meal, SUNRIDGE/CDL
PROTEIN Blend, LOURENZO, K PVM DAIRY Meal, DOUBLE B DAIRY/GHC LAC Mineral, WEST
PIONT/GHC CLOSEUP Mineral, WEST POINT/GHC LACT Meal, JENKS, J/COMPASS PROTEIN
Meal, COPPINI - 8# SPECIAL DAIRY Mix, GULICK, L-LACT Meal (Bulk), TRIPLE J -
PROTEIN/LACTATION, ROCK CREEK/GHC MILK Mineral, BETTENCOURT/GHC S.SIDE MK-MN,
BETTENCOURT #1/GHC MILK MINR, V&C DAIRY/GHC LACT Meal, VEENSTRA, F/GHC LACT
Meal, SMUTNY, A- BYPASS ML W/SMARTA, Recall # V-025-2007
CODE
The firm does not utilize a code - only shipping documentation with
commodity and weights identified.
RECALLING FIRM/MANUFACTURER
Rangen, Inc, Buhl, ID, by letters on February 13 and 14, 2007. Firm
initiated recall is complete.
REASON
Products manufactured from bulk feed containing blood meal that was cross
contaminated with prohibited meat and bone meal and the labeling did not bear
cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
9,997,976 lbs.
DISTRIBUTION
ID and NV
END OF ENFORCEMENT REPORT FOR MARCH 21, 2007
Subject: bovine blood meal was cross-contaminated with prohibited bovine
meat and bone meal 1,366,128 lbs. WI, TX, NE, TN, CO, and MN FEBRUARY 7, 2007
PRODUCT
Bulk Darling's 85% Blood Meal, Flash Dried, distributed in totes and in
1-ton bags (for one customer only), Recall # V-012-2007
CODE
Blood meal distributed between 9/7/2006-2/3/2007.
RECALLING FIRM/MANUFACTURER
Darling National LLC, Omaha, NB, by telephone on January 12, 2007. Firm
initiated recall is ongoing.
REASON
Some of the exempt bovine blood meal was cross-contaminated with prohibited
bovine meat and bone meal that had been manufactured on common equipment and the
labeling did not bear the cautionary BSE statement that it should not be fed to
ruminants.
VOLUME OF PRODUCT IN COMMERCE
1,366,128 lbs.
DISTRIBUTION
WI, TX, NE, TN, CO, and MN
END OF ENFORCEMENT REPORT FOR FEBRUARY 7, 2007
###
PRODUCT
O-NO-MORE (Formerly ORPHAN-NO-MORE) Calf Claimer Powder, packaged in 11-oz.
bottles, For Animal Use Only. Recall # V-043-2007
CODE
A06
RECALLING FIRM/MANUFACTURER
Springer Magrath Co., Mc Cook, NE, by telephone on January 2, 2007, fax
dated January 9, 2007, by letters on February 22, 2007, March 12, March 14 and
March 21, 2007. Firm initiated recall is ongoing.
REASON
The finished product was manufactured with prohibited bovine blood meal and
did not bear the cautionary BSE statement that the product should not be fed to
ruminants.
VOLUME OF PRODUCT IN COMMERCE
Approximately 13,255 bottles
DISTRIBUTION
Nationwide
END OF ENFORCEMENT REPORT FOR JUNE 13, 2007 ###
remember, .005 grams is more than enough to be lethal. ...tss
Saturday, December 15, 2012
*** Bovine spongiform encephalopathy: the effect of oral exposure dose on
attack rate and incubation period in cattle -- an update 5 December 2012
Rangen Inc 2/11/10 Department of Health and Human Services Public Health
Service Food and Drug Administration Seattle District Pacific Region 22201 23rd
Drive SE Bothell, WA 98021-4421 Telephone: 425-486-8788 FAX: 425-483-4996
February 11, 2010
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 10-11
Christopher T. Rangen, President Rangen, Inc. 115-13th Avenue South PO Box
706 Buhl, Idaho 83316
WARNING LETTER
Dear Mr. Rangen:
On June 9-11, 2009, U.S. Food and Drug Administration (FDA) investigators
inspected your animal feed manufacturing facilities located at 115-13th Avenue
South, Buhl, Idaho. The inspection revealed significant deviations from the
requirements set forth in Title 21, Code of Federal Regulations, Section
589.2000 (21 C.F.R. 589.2000), Animal Proteins Prohibited in Ruminant Feed. This
regulation is intended to prevent the establishment and amplification of Bovine
Spongiform Encephalopathy (BSE). You failed to follow the requirements of this
regulation, resulting in products being manufactured and distributed by your
facility that were adulterated within the meaning of section 402(a)(4) of the
Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), and
misbranded within the meaning of section 403(a)(1) of the Act, 21 U.S.C. §
343(a)(1). Our investigation determined that adulteration resulted from the
failure of your firm to provide for measures to avoid commingling or
cross-contamination. The adulterated feed was subsequently misbranded because it
was not properly labeled. Specifically,
we found:
1. Your firm failed to provide for and use cleanout procedures or other
means adequate to prevent carry-over of products that contain or may contain
proteins derived from mammalian tissues into animal feed that may be used for
ruminants, as required by 21 CFR 589.2000(e)(1)(iii)(B). Since your feed is
prepared, packed, or held under these conditions it is, therefore, adulterated
under section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).
• Mink feed that was not labeled "Do not feed to cattle or other
ruminants," in accordance with 21 CFR 589.2000(e)(1)(i) and that, therefore,
might be fed to ruminants, was produced using the same equipment as aquaculture
feed that contains proteins derived from mammalian tissues, such as meat and
bone meal. You conducted no clean-outs or flushes of equipment to remove
proteins derived from mammalian tissues that may have been present before
manufacturing the mink feed that might be fed to ruminants.
• The auger trucks you used to deliver bulk mink feed which contained or
may have contained proteins derived from mammalian tissues were not subject to
an effective clean-out prior to their use to deliver bulk animal feed, including
ruminant feed, that did not contain such materials. There were no procedures to
clean the trucks to remove proteins derived from mammalian tissues before
shipment of animal feeds that did not contain such materials.
2. You failed to label all products which contained or may have contained
proteins derived from mammalian tissues with the statement, "Do not feed to
cattle or other ruminants," as required by 21 C.F.R. 589.2000(e)(1)(i). Such
products are misbranded under Section 403(a)(1) of the Act, 21 U.S.C. §
343(a)(1). The misbranded product includes bulk mink feed.
• On June 9, 2009, the investigators observed approximately (b)(4) pallets
of (b)(4) 50 pound bags of (b)(4) MINK FEED, lot 06/05/09. All bagged mink feed,
as well as approximately (b)(4)% of bulk mink feed, manufactured at your
facility, was produced using the aquaculture feed production equipment used to
produce feed containing proteins derived from mammalian tissues. Because mink
feed produced using this equipment may have contained mammalian tissues, it was
not properly labeled, as required by 21 C.F.R. 589.2000(e)(1)(i).
This letter is not intended to serve as an all-inclusive list of
violations at your facility. As a manufacturer of materials intended for animal
feed use, you are responsible for ensuring your overall operation and the
products you manufacture and distribute are in compliance with the law. You
should take prompt action to correct the above violations and you should
establish a system whereby violations do not occur. Failure to promptly correct
these violations may result in regulatory action, such seizure and/or
injunction, without further notice.
We acknowledge your July 31, 2009 letter detailing procedures you had
implemented or planned to implement to prevent future violations of FDA
regulations relating to mammalian proteins in animal feed. In particular the
letter stated that Rangen would no longer purchase meat and bone meal for use in
any of its animal feeds and that existing inventories of mammalian protein
ingredients would be exhausted by December 31, 2009. Division Manager, Joy
Kinyon made similar assertions in the course of FDA's June 2009 inspection. The
July 31, 2009 letter further set out procedures Rangen would use to remedy
observed violations of FDA regulations while mammalian proteins were still being
used at Rangen. Finally you explained steps taken to recover or relabel feed
that may have been contaminated due to commingling resulting from your
manufacturing and distribution procedures. Within fifteen (15) working days of
receiving this letter you should, in writing, confirm the steps you took prior
to receiving this letter and notify FDA of steps you have taken since receiving
this letter to bring your firm into compliance with the law. Your response
should include each step that has been taken or will be taken to correct the
violations and prevent their recurrence. If corrective action cannot be
completed within fifteen (15) working days, state the reason for the delay and
the time frame within which the corrections will be completed. Please include
copies of any available documentation demonstrating that corrections have been
made.
Your written reply should be directed to Scott A. Nabe, Compliance
Officer, U.S. Food and Drug Administration, 22201 23rd Drive SE, Bothell,
Washington 98021-4421. If you have any questions about this letter, please
contact Mr. Nabe at (425) 483-4753.
Sincerely,
/s/
Charles M. Breen District Director Seattle District
cc: Joy A. Kinyon, Division Manager, Aquaculture Feeds-General Feeds
Rangen, Inc. PO Box 706 115-13th Avenue South Buhl, Idaho 83316
C O N F I R M E D
----- Original Message -----
From: "Terry S. Singeltary Sr."
To:
Sent: Thursday, November 05, 2009 9:25 PM
Subject: [BSE-L] re-FOIA REQUEST ON FEED RECALL PRODUCT contaminated with
prohibited material Recall # V-258-2009 and Recall # V-256-2009
Thursday, November 12, 2009
BSE FEED RECALL Misbranding of product by partial label removal to hide
original source of materials 2009
CVM Annual Report Fiscal Year 2008: October 1, 2007-September 30,
2008
PUTTING LIPSTICK ON A PIG AND TAKING HER TO A DANCE...TSS
BSE Feed Rule Enforcement: A Decade of Success OFF TO A FAST START
Tuesday, March 2, 2010
Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded Rangen
Inc 2/11/10 USA
Thursday, January 14, 2010
SAMPLE COLLECTION FROM CATTLE UNDER THE BOVINE SPONGIFORM ENCEPHALOPATHY
(BSE) ONGOING SURVEILLANCE PROGRAM FSIS NOTICE 05-10 1/12/10
The most recent assessments (and reassessments) were published in June 2005
(Table I; 18), and included the categorisation of Canada, the USA, and Mexico as
GBR III. Although only Canada and the USA have reported cases, the historically
open system of trade in North America suggests that it is likely that BSE is
present also in Mexico.
Tuesday, July 14, 2009
U.S. Emergency Bovine Spongiform Encephalopathy Response Plan Summary and
BSE Red Book Date: February 14, 2000 at 8:56 am PST
WHERE did we go wrong $$$
Sunday, January 17, 2010
BSE USA feed inspection violations 01/01/2009 to 01/17/2010
HISTORY F.O.I.A.
Saturday, August 29, 2009
FOIA REQUEST FEED RECALL 2009 Product may have contained prohibited
materials Bulk Whole Barley, Recall # V-256-2009
Thursday, September 3, 2009
429,128 lbs. feed for ruminant animals may have been contaminated with
prohibited material Recall # V-258-2009
Friday, September 4, 2009
FOIA REQUEST ON FEED RECALL PRODUCT 429,128 lbs. feed for ruminant animals
may have been contaminated with prohibited material Recall # V-258-2009
Tuesday, November 3, 2009
re-FOIA REQUEST ON FEED RECALL PRODUCT contaminated with prohibited
material Recall # V-258-2009 and Recall # V-256-2009
Saturday, June 12, 2010
PUBLICATION REQUEST AND FOIA REQUEST Project Number: 3625-32000-086-05
Study of Atypical Bse
Wednesday, July 28, 2010
re-Freedom of Information Act Project Number 3625-32000-086-05, Study of
Atypical BSE UPDATE July 28, 2010
Friday, October 8, 2010
Scientific reasons for a feed ban of meat-and-bone meal, applicable to all
farmed animals including cattle, pigs, poultry, farmed fish and pet food
Saturday, November 6, 2010
TAFS1 Position Paper on Position Paper on Relaxation of the Feed Ban in the
EU
Berne, 2010 TAFS INTERNATIONAL FORUM FOR TRANSMISSIBLE ANIMAL DISEASES AND
FOOD SAFETY a non-profit Swiss Foundation
Archive Number 20101206.4364 Published Date 06-DEC-2010 Subject
PRO/AH/EDR>
Prion disease update 2010 (11) PRION DISEASE UPDATE 2010 (11)
P.9.21
Molecular characterization of BSE in Canada
Jianmin Yang1, Sandor Dudas2, Catherine Graham2, Markus Czub3, Tim
McAllister1, Stefanie Czub1 1Agriculture and Agri-Food Canada Research Centre,
Canada; 2National and OIE BSE Reference Laboratory, Canada; 3University of
Calgary, Canada
Background: Three BSE types (classical and two atypical) have been
identified on the basis of molecular characteristics of the misfolded protein
associated with the disease. To date, each of these three types have been
detected in Canadian cattle.
Objectives: This study was conducted to further characterize the 16
Canadian BSE cases based on the biochemical properties of there associated
PrPres. Methods: Immuno-reactivity, molecular weight, glycoform profiles and
relative proteinase K sensitivity of the PrPres from each of the 16 confirmed
Canadian BSE cases was determined using modified Western blot analysis.
Results: Fourteen of the 16 Canadian BSE cases were C type, 1 was H type
and 1 was L type. The Canadian H and L-type BSE cases exhibited size shifts and
changes in glycosylation similar to other atypical BSE cases. PK digestion under
mild and stringent conditions revealed a reduced protease resistance of the
atypical cases compared to the C-type cases. N terminal- specific antibodies
bound to PrPres from H type but not from C or L type. The C-terminal-specific
antibodies resulted in a shift in the glycoform profile and detected a fourth
band in the Canadian H-type BSE.
Discussion: The C, L and H type BSE cases in Canada exhibit molecular
characteristics similar to those described for classical and atypical BSE cases
from Europe and Japan. This supports the theory that the importation of BSE
contaminated feedstuff is the source of C-type BSE in Canada. *It also suggests
a similar cause or source for atypical BSE in these countries.
Saturday, August 4, 2012
*** Final Feed Investigation Summary - California BSE Case - July 2012
What irks many scientists is the USDA’s April 25 statement that the rare
disease is “not generally associated with an animal consuming infected feed.”
The USDA’s conclusion is a “gross oversimplification,” said Dr. Paul Brown,
one of the world’s experts on this type of disease who retired recently from the
National Institutes of Health.
"(The agency) has no foundation on which to base that statement.”
“We can’t say it’s not feed related,” agreed Dr. Linda Detwiler, an
official with the USDA during the Clinton Administration now at Mississippi
State.
In the May 1 email to me, USDA’s Cole backed off a bit. “No one knows the
origins of atypical cases of BSE,” she said
Saturday, May 26, 2012
Are USDA assurances on mad cow case 'gross oversimplification'?
Monday, March 25, 2013
Minnesota Firm Recalls Bone-In Ribeye That May Contain Specified Risk
Materials Recall Release CLASS II RECALL FSIS-RC-024-2013
Ohio Department of Agriculture and Ohio Department of Health
Governor
John R. Kasich
Lieutenant Governor
Mary Taylor
ODA Director
James Zehringer
ODH Director
Theodore E. Wymyslo, M.D.
DT: July 14, 2011
TO: Health Commissioners, Directors of Environmental Health and Interested
Parties
RE: Recall Announcement (ODA/ODH) 2011-076
Valley Farm Meats (DBA Strasburg Provision, Inc) Issues Precautionary
Recall for Beef Products Due to Possible Contamination with Prohibited Materials
snip...end...TSS
=========================================
Ohio Department of Agriculture and Ohio Department of Health
Governor
John R. Kasich Lieutenant Governor Mary Taylor ODA Director James Zehringer
ODH Director Theodore E. Wymyslo, M.D.
DT: July 14, 2011
TO: Health Commissioners, Directors of Environmental Health and Interested
Parties
RE: Recall Announcement (ODA/ODH) 2011-076
Valley Farm Meats (DBA Strasburg Provision, Inc) Issues Precautionary
Recall for Beef Products Due to Possible Contamination with Prohibited Materials
[STRASBURG, Ohio] – Valley Farm Meats (DBA Strasburg Provision, Inc) of
Strasburg, OH announces a voluntary recall of an unknown amount of beef products
that may contain the spinal cord and vertebral column, which are considered
specified risk materials (SRMs). SRMs must be removed from cattle over 30 months
of age in accordance with federal and state regulations. SRMs are tissues that
are known to contain the infective agent in cattle infected with Bovine
Spongiform Encephalopathy (BSE), as well as materials that are closely
associated with these potentially infective tissues. Therefore, federal and
state regulations prohibit SRMs from use as human food to minimize potential
human exposure to the BSE agent.
The products subject to recall include all beef products slaughtered and
processed by or purchased from Valley Farm Meats retail store, 1317 N. Wooster
Ave NW, Strasburg, OH 44680 or purchased from Ed Lind Livestock and Poultry,
3333 Church Rd B, Medina, Ohio 44256. These products were produced between
01/28/2011 and 07/05/2011 and offered for sale from 01/28/2011 through
07/11/2011. The package labels or beef carcasses may bear the Ohio mark of
inspection and “Est. 80”, however products processed through Ed Lind Livestock
and Poultry may not contain such markings. The problem was discovered through
routine inspection activities by the Ohio Department of Agriculture’s Division
of Meat Inspection. The Department has received no reports of illnesses
associated with consumption of this product. The United States Department of
Agriculture’s Food Safety and Inspection Service classifies this type of
potential contamination as a low health risk, however individuals concerned
about an illness should contact a health care provider. Because of potential
product contamination, Valley Farm Meats urges its customers who have purchased
the suspect product(s) not to eat them and to return them to the company.
Customers may bring those designated packages to Valley Farm Meats, 1317 N
Wooster Avenue NW, Strasburg, OH 44680 during regular business hours or call the
company’s owner, Paul Berry at 330-878-5557.
see old FSIS example of SRM recalls from the past ;
North Dakota Firm Recalls Whole Beef Head Products That Contain Prohibited
Materials
Recall Release CLASS II RECALL FSIS-RC-023-2010 HEALTH RISK: LOW
Congressional and Public Affairs (202) 720-9113 Catherine Cochran
WASHINGTON, April 5, 2010 - North American Bison Co-Op, a New Rockford, N.D.,
establishment is recalling approximately 25,000 pounds of whole beef heads
containing tongues that may not have had the tonsils completely removed, which
is not compliant with regulations that require the removal of tonsils from
cattle of all ages, the U.S. Department of Agriculture's Food Safety and
Inspection Service (FSIS) announced today.
Tonsils are considered a specified risk material (SRM) and must be removed
from cattle of all ages in accordance with FSIS regulations. SRMs are tissues
that are known to contain the infective agent in cattle infected with Bovine
Spongiform Encephalopathy (BSE), as well as materials that are closely
associated with these potentially infective tissues. Therefore, FSIS prohibits
SRMs from use as human food to minimize potential human exposure to the BSE
agent.
The product subject to recall includes: Various weight cases of "Beef Heads
KEEP FROZEN." Each case bears the establishment number "EST. 18859" inside the
USDA mark of inspection and a case code number "16999." "North Dakota Natural
Beef" is printed in the bottom left-hand corner of each label.
The recalled products were produced between June 25, 2009, and February 19,
2010. These products were shipped to distribution centers in Md., Mich., and
Minn. for further sale. The problem was discovered during FSIS inspection
activities at the establishment. FSIS routinely conducts recall effectiveness
checks to verify recalling firms notify their customers of the recall and that
steps are taken to make certain that the product is no longer available to
consumers.
Media with questions about the recall should contact Philip Wicke, Vice
President of Operations, at (701) 356-7723. Consumers with questions about the
recall should contact Jeremy Anderson, Director of Customer Service, at (952)
545-2495
Consumers with food safety questions can "Ask Karen," the FSIS virtual
representative available 24 hours a day at AskKaren.gov. The toll-free USDA Meat
and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and
Spanish and can be reached from l0 a.m. to 4 p.m. (Eastern Time) Monday through
Friday. Recorded food safety messages are available 24 hours a day. #
Missouri Firm Recalls Cattle Heads That Contain Prohibited Materials
Recall Release CLASS II RECALL FSIS-RC-021-2008 HEALTH RISK: LOW
Congressional and Public Affairs (202) 720-9113 Amanda Eamich
WASHINGTON, June 26, 2008 – Paradise Locker Meats, a Trimble, Mo.,
establishment, is voluntarily recalling approximately 120 pounds of fresh cattle
heads with tonsils not completely removed, which is not compliant with
regulations that require the removal of tonsils from cattle of all ages, the
U.S. Department of Agriculture’s Food Safety and Inspection Service announced
today.
Tonsils are considered a specified risk material (SRM) and must be removed
from cattle of all ages in accordance with FSIS regulations. SRMs are tissues
that are known to contain the infective agent in cattle infected with BSE, as
well as materials that are closely associated with these potentially infective
tissues. Therefore, FSIS prohibits SRMs from use as human food to minimize
potential human exposure to the BSE agent. The products subject to recall
include: Boxes of “BEEF HEAD, PARADISE LOCKER MEATS.” Each shipping package
bears the establishment numbers “EST. 31865” inside the USDA mark of inspection.
These products were sent to retail establishments and restaurants in the Kansas
City, Kansas, area.
The problem was discovered through routine FSIS inspection that verified
there had been incomplete removal of the tonsils by the recalling establishment.
Media and consumers with questions about the recall should contact company
Production Supervisor Louis Fantasma at (816) 370-6328.
Consumers with food safety questions can “Ask Karen,” the FSIS virtual
representative available 24 hours a day at AskKaren.gov. The toll-free USDA Meat
and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and
Spanish and can be reached from l0 a.m. to 4 p.m. (Eastern Time) Monday through
Friday. Recorded food safety messages are available 24 hours a day. #
HAS the greed and money gotten so bad that the FSIS, USDA, APHIS, OIE et
al, just decided that not only to exempt the atypical Scrapies and apparently
now the BSE's, exempt them all, and just agreed to choose to not even speak
about it anymore. i mean...really, the USDA and OIE have systematically covered
up mad cow disease i.e. they call it SSS policy. where is USA burying them all
at ? i do not accept the star trek like cloaking device that appears to be the
only thing left that could be protecting the USA from mad cow disease....really.
sadly, Canada has now taken the same low road as the USA in regards to
discussing and making public documents on there mad cow cases. all this, 2011,
with the science mounting, still follow the global myth of the UKBSEnvCJD only
theory, and that all the sporadic CJDs (85%+ of all human TSE) are a mear
happenstance of bad luck, when North America is plum full of different strains
of the Transmissible Spongiform Encephalopathy in different species, all of
which over a period of time, decades, were rendered and fed to food producing
animals for human and animal food...really. i really just don't buy it...tss
some history on SRM's IN COMMERCE ;
SEE FULL TEXT HERE ;
Tuesday, July 1, 2008
Missouri Firm Recalls Cattle Heads That Contain Prohibited Materials
SRMs
Sunday, October 18, 2009
Wisconsin Firm Recalls Beef Tongues That Contain Prohibited Materials SRM
WASHINGTON, October 17, 2009
Thursday, October 15, 2009
Nebraska Firm Recalls Beef Tongues That Contain Prohibited Materials SRM
WASHINGTON, Oct 15, 2009
Thursday, June 26, 2008
Texas Firm Recalls Cattle Heads That Contain Prohibited Materials
Friday, August 8, 2008
Texas Firm Recalls Cattle Heads That Contain Prohibited Materials SRMs
941,271 pounds with tonsils not completely removed
Saturday, April 5, 2008
SRM MAD COW RECALL 406 THOUSAND POUNDS CATTLE HEADS WITH TONSILS
KANSAS
Wednesday, April 30, 2008
Consumption of beef tongue: Human BSE risk associated with exposure to
lymphoid tissue in bovine tongue in consideration of new research findings
Friday, October 15, 2010
BSE infectivity in the absence of detectable PrPSc accumulation in the
tongue and nasal mucosa of terminally diseased cattle
SPECIFIED RISK MATERIALS SRMs
Archive Number 20101206.4364 Published Date 06-DEC-2010 Subject
PRO/AH/EDR> Prion disease update 2010 (11)
PRION DISEASE UPDATE 2010 (11)
Saturday, November 6, 2010
TAFS1 Position Paper on Position Paper on Relaxation of the Feed Ban in the
EU Berne, 2010 TAFS
INTERNATIONAL FORUM FOR TRANSMISSIBLE ANIMAL DISEASES AND FOOD SAFETY a
non-profit Swiss Foundation
*** The potential impact of prion diseases on human health was greatly
magnified by the recognition that interspecies transfer of BSE to humans by beef
ingestion resulted in vCJD. While changes in animal feed constituents and
slaughter practices appear to have curtailed vCJD, there is concern that CWD of
free-ranging deer and elk in the U.S. might also cross the species barrier.
Thus, consuming venison could be a source of human prion disease. Whether BSE
and CWD represent interspecies scrapie transfer or are newly arisen prion
diseases is unknown. Therefore, the possibility of transmission of prion disease
through other food animals cannot be ruled out. There is evidence that vCJD can
be transmitted through blood transfusion. There is likely a pool of unknown size
of asymptomatic individuals infected with vCJD, and there may be asymptomatic
individuals infected with the CWD equivalent. These circumstances represent a
potential threat to blood, blood products, and plasma supplies.
The chances of a person or domestic animal contracting CWD are “extremely
remote,” Richards said. The possibility can’t be ruled out, however. “One could
look at it like a game of chance,” he explained. “The odds (of infection)
increase over time because of repeated exposure. That’s one of the downsides of
having CWD in free-ranging herds: We’ve got this infectious agent out there that
we can never say never to in terms of (infecting) people and domestic
livestock.”
2011
*** After a natural route of exposure, 100% of white-tailed deer were
susceptible to scrapie.
This work demonstrates that WTD are highly susceptible to sheep scrapie,
but on first passage, scrapie in WTD is differentiable from CWD.
4.Accomplishments 1. Deer inoculated with domestic isolates of sheep
scrapie. Scrapie-affected deer exhibit 2 different patterns of disease
associated prion protein. In some regions of the brain the pattern is much like
that observed for scrapie, while in others it is more like chronic wasting
disease (CWD), the transmissible spongiform encephalopathy typically associated
with deer. This work conducted by ARS scientists at the National Animal Disease
Center, Ames, IA suggests that an interspecies transmission of sheep scrapie to
deer may have been the origin of CWD. This is important for husbandry practices
with both captive deer, elk and sheep for farmers and ranchers attempting to
keep their herds and flocks free of CWD and scrapie.
pens, pens, PENS ???
*** Spraker suggested an interesting explanation for the occurrence of CWD.
The deer pens at the Foot Hills Campus were built some 30-40 years ago by a Dr.
Bob Davis. At or abut that time, allegedly, some scrapie work was conducted at
this site. When deer were introduced to the pens they occupied ground that had
previously been occupied by sheep.
Friday, November 09, 2012
*** Chronic Wasting Disease CWD in cervidae and transmission to other
species
Sunday, November 11, 2012
*** Susceptibilities of Nonhuman Primates to Chronic Wasting Disease
November 2012
Friday, December 14, 2012
Susceptibility Chronic Wasting Disease (CWD) in wild cervids to Humans 2005
- December 14, 2012
Saturday, March 09, 2013
Chronic Wasting Disease in Bank Voles: Characterisation of the Shortest
Incubation Time Model for Prion Diseases
Wednesday, November 14, 2012
PENNSYLVANIA 2012 THE GREAT ESCAPE OF CWD INVESTIGATION MOVES INTO
LOUISIANA and INDIANA
***SEE UPDATE !
Tuesday, May 28, 2013
Chronic Wasting Disease CWD quarantine Louisiana via CWD index herd
Pennsylvania Update May 28, 2013
6 doe from Pennsylvania CWD index herd still on the loose in Louisiana,
quarantine began on October 18, 2012, still ongoing, Lake Charles premises.
Thursday, March 14, 2013
TEXAS DEER BREEDERS CHEER TWO NEW BILLS SB 1444 AND HB 2092 THAT COULD HELP
POTENTIALLY ENHANCE CHRONIC WASTING DISEASE CWD
Thursday, May 02, 2013
Chronic Wasting Disease (CWD) Texas Important Update on OBEX ONLY TEXTING
Monday, March 18, 2013
PROCEEDINGS ONE HUNDRED AND FIFTEENTH ANNUAL MEETING of the UNITED STATES
ANIMAL HEALTH ASSOCIATION September 29 – October 5, 2011
see updated 2012 RESOLUTIONS
Friday, December 14, 2012
DEFRA U.K. What is the risk of Chronic Wasting Disease CWD being introduced
into Great Britain? A Qualitative Risk Assessment October 2012
snip...
In the USA, under the Food and Drug Administration’s BSE Feed Regulation
(21 CFR 589.2000) most material (exceptions include milk, tallow, and gelatin)
from deer and elk is prohibited for use in feed for ruminant animals. With
regards to feed for non-ruminant animals, under FDA law, CWD positive deer may
not be used for any animal feed or feed ingredients. For elk and deer considered
at high risk for CWD, the FDA recommends that these animals do not enter the
animal feed system. However, this recommendation is guidance and not a
requirement by law.
Animals considered at high risk for CWD include:
1) animals from areas declared to be endemic for CWD and/or to be CWD
eradication zones and
2) deer and elk that at some time during the 60-month period prior to
slaughter were in a captive herd that contained a CWD-positive animal.
Therefore, in the USA, materials from cervids other than CWD positive
animals may be used in animal feed and feed ingredients for non-ruminants.
The amount of animal PAP that is of deer and/or elk origin imported from
the USA to GB can not be determined, however, as it is not specified in TRACES.
It may constitute a small percentage of the 8412 kilos of non-fish origin
processed animal proteins that were imported from US into GB in 2011.
Overall, therefore, it is considered there is a __greater than negligible
risk___ that (nonruminant) animal feed and pet food containing deer and/or elk
protein is imported into GB.
There is uncertainty associated with this estimate given the lack of data
on the amount of deer and/or elk protein possibly being imported in these
products.
snip...
36% in 2007 (Almberg et al., 2011). In such areas, population declines of
deer of up to 30 to 50% have been observed (Almberg et al., 2011). In areas of
Colorado, the prevalence can be as high as 30% (EFSA, 2011).
The clinical signs of CWD in affected adults are weight loss and
behavioural changes that can span weeks or months (Williams, 2005). In addition,
signs might include excessive salivation, behavioural alterations including a
fixed stare and changes in interaction with other animals in the herd, and an
altered stance (Williams, 2005). These signs are indistinguishable from cervids
experimentally infected with bovine spongiform encephalopathy (BSE).
Given this, if CWD was to be introduced into countries with BSE such as GB,
for example, infected deer populations would need to be tested to differentiate
if they were infected with CWD or BSE to minimise the risk of BSE entering the
human food-chain via affected venison.
snip...
The rate of transmission of CWD has been reported to be as high as 30% and
can approach 100% among captive animals in endemic areas (Safar et al., 2008).
snip...
In summary, in endemic areas, there is a medium probability that the soil
and surrounding environment is contaminated with CWD prions and in a
bioavailable form. In rural areas where CWD has not been reported and deer are
present, there is a greater than negligible risk the soil is contaminated with
CWD prion.
snip...
In summary, given the volume of tourists, hunters and servicemen moving
between GB and North America, the probability of at least one person travelling
to/from a CWD affected area and, in doing so, contaminating their clothing,
footwear and/or equipment prior to arriving in GB is greater than negligible.
For deer hunters, specifically, the risk is likely to be greater given the
increased contact with deer and their environment. However, there is significant
uncertainty associated with these estimates.
snip...
Therefore, it is considered that farmed and park deer may have a higher
probability of exposure to CWD transferred to the environment than wild deer
given the restricted habitat range and higher frequency of contact with tourists
and returning GB residents.
snip...
Friday, December 14, 2012
DEFRA U.K. What is the risk of Chronic Wasting Disease CWD being introduced
into Great Britain? A Qualitative Risk Assessment October 2012
Tuesday, April 16, 2013
Cervid Industry Unites To Set Direction for CWD Reform and seem to ignore
their ignorance and denial in their role in spreading Chronic Wasting
Disease
Monday, June 3, 2013
Unsuccessful oral transmission of scrapie from British sheep to cattle
snip...
A kind greetings from Bacliff, Texas !
I have often pondered if the whole damn mad cow follies started over here
in the USA, and somehow, the USA shipped it over to the UK ?
It happened with S. Korea and CWD, via Canada. see ;
The disease was confirmed only in elk in the Republic of Korea in 2001,
2004 and 2005. Epidemiological investigations showed that CWD was introduced via
importation of infected elk from Canada between 1994 and 1997.
but I still am not so sure that the mad cow follies did not start long ago
right here in the USA i.e. Richard Marsh and deadstock downer cattle to those
mink, and then the USA shipped it to hell and back. just pondering out loud
here. ...tss
The exact same recipe for B.S.E. existed in the U.S. for years
and years. In reading over the Qualitative Analysis of BSE
Risk Factors-1, this is a 25 page report by the
USDA:APHIS:VS. It could have been done in one page. The
first page, fourth paragraph says it all;
"Similarities exist in the two countries usage of continuous
rendering technology and the lack of usage of solvents,
however, large differences still remain with other risk factors
which greatly reduce the potential risk at the national level."
Then, the next 24 pages tries to down-play the high risks of
B.S.E. in the U.S., with nothing more than the cattle to sheep
ratio count, and the geographical locations of herds and flocks.
That's all the evidence they can come up with, in the next 24
pages.
Something else I find odd, page 16;
"In the United Kingdom there is much concern for a specific
continuous rendering technology which uses lower
temperatures and accounts for 25 percent of total output. This
technology was _originally_ designed and imported from the
United States. However, the specific application in the
production process is _believed_ to be different in the two
countries."
A few more factors to consider, page 15;
"Figure 26 compares animal protein production for the two
countries. The calculations are based on slaughter numbers,
fallen stock estimates, and product yield coefficients. This
approach is used due to variation of up to 80 percent from
different reported sources. At 3.6 million tons, the United
States produces 8 times more animal rendered product than
the United Kingdom."
"The risk of introducing the BSE agent through sheep meat and
bone meal is more acute in both relative and absolute terms in
the United Kingdom (Figures 27 and 28). Note that sheep
meat and bone meal accounts for 14 percent, or 61 thousand
tons, in the United Kingdom versus 0.6 percent or 22 thousand
tons in the United States. For sheep greater than 1 year, this is
less than one-tenth of one percent of the United States supply."
"The potential risk of amplification of the BSE agent through
cattle meat and bone meal is much greater in the United States
where it accounts for 59 percent of total product or almost 5
times more than the total amount of rendered product in the
United Kingdom."
Considering, it would only take _one_ scrapie infected sheep
to contaminate the feed. Considering Scrapie has run rampant
in the U.S. for years, as of Aug. 1999, 950 scrapie infected
flocks. Also, Considering only one quarter spoonful of scrapie
infected material is lethal to a cow. Considering all this, the
sheep to cow ration is meaningless. As I said, it's 24 pages of
B.S.e.
To be continued...
Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA
_____________________________________________________________________
Qualitative Assessment Considering the comparative factors presented, with
the exception of some similarities in rendering practices, epidemiologic factors
believed conducive to the introduction of BSE in the United Kingdom are
significantly different in the United States. This is supported by the following
points: Similar changes in the rendering practices have occurred in both
countries. Continuous rendering accounts for the vast majority of all product
produced. From 1977 to 1982, the portion of United Kingdom product rendered
using hydrocarbon solvents dropped from 70 per-cent to 10 percent. Within the
United States the decline was at least 5 years earlier with very little if any
solvent in current use.
see full text ;
TME in mink was documented in the early 1960s. it was first thought that
the TME out break was from scrapie infected sheep, until a investigation was
done on feed practices at these mink facilities, and it was later found that the
mink had been fed 95%+ dead stock downer cows. and later, the Late Richard Marsh
tried to warn the feds of the pending mad cow debacle. they refused to listen.
... some interesting reading on pages 26 to 33
1979
TME originates from feeding mink, scrapie infected materials...
Evidence That Transmissible Mink Encephalopathy Results from Feeding
Infected Cattle
Over the next 8-10 weeks, approximately 40% of all the adult mink on the
farm died from TME.
snip...
The rancher was a ''dead stock'' feeder using mostly (>95%) downer or
dead dairy cattle...
Tuesday, July 21, 2009
Transmissible mink encephalopathy - review of the etiology
Folia Neuropathologica 2/2009
full text of the article:
Transmissible mink encephalopathy – review of the etiology
Folia Neuropathol 2009; 47 (2): 195-204
snip...
A possible clue was provided during the Stetsonville TME outbreak in which
the rancher fed his mink commercial feed (e.g., poultry, fish, cereal) and fresh
meat primarily from sick or downer dairy cattle within a 50-mile radius of his
ranch [37]. He did not recall including sheep products in his homemade feed
ration. Upon reviewing prior TME outbreaks in the U.S. and Canada, in all four
cases in which records were available and were not linked to a commercial feed
plant, downer cattle were also included in the mink diet. The Stetsonville TME
isolate, and subsequently additional TME isolates, were transmitted to cattle by
intracerebral inoculation and the Stetsonville TME isolate was the first
confirmed case of experimental transmission of a TSE/prion disease to cattle.
What was striking was that upon experimental transmission of cattle TME back
into mink by the oral and intracerebral routes, the incubation periods were
similar to that found for mink passaged TME. Hence, the pathogenicity of the
Stetsonville TME agent in mink was not altered upon passage into cattle,
suggesting that a previously unrecognized TSE/prion disease in cattle may be the
source of TME infection. Additional studies strongly suggest that TME has
similarities to L-type BSE in transgenic mice compared to H-type or classical
BSE [2]. Since the L-type BSE does not appear to be an infectious form of
TSE/prion disease, the proposal by Marsh [35,37] that a rare TSE in cattle may
be the source of TME infection seems plausible. This is particularly the case in
Wisconsin, which has had the majority of TME in the USA and is a prominent dairy
state with aged cattle being a primary source of fresh meat for mink ration.
Since mink are a sentinel host it is not surprising that they may have been a
key host in amplifying a rare cattle TSE disease. Another possible explanation
for the high incidence of TME in Wisconsin is based on the recent identification
of a mutation in the prion protein gene in cattle with atypical BSE. There may
be cattle breeding stock in Wisconsin that carry a mutation in the prion protein
gene that is linked to late onset disease and are also the source of TSE
infection for mink TME outbreaks described in the 1960s and 1985.
snip...
To this end, mink were shown to be sensitive to scrapie [23,24]. Of
interest, following i.c. inoculation with the UK source of scrapie from a
Suffolk sheep only a single animal developed the disease. In contrast, American
sources B-834 and B-957 from Suffolk sheep readily transmitted to mink. Also, in
another outbreak of TME in Stetsonville, Wisconsin, USA, the affected mink were
apparently fed with downer cattle but not scrapie-affected sheep [32], and thus
TME may result from BSE transmission from cattle to mink [37]. TME is readily
transmitted to cattle [26]. The suggestion that TME may result from transmission
from infected cattle but not sheep was supported by recent data on phenotypic
similarities of TME in cattle and L-type bovine spongiform encephalopathy (BSE)
transmitted to ovine transgenic mice (TgOvPrP4) [2]. To this end, L-type of BSE
and TME in TgOvPrP4 presented similar molecular mass of all 3 bands of PrPd.
Unglycosylated PrPd in L-type BSE, bovine TME and typical BSE has the same
molecular mass of approximately 18 kDa in contrast to that of diglycosylated
PrPd species which was lower by 0.5-0.8 kDa in L-type BSE and bovine TME as
compared to typical BSE. Furthermore, L-type BSE and bovine TME transmitted to
TgOvPrP4 mice presented spongiform change of low intensity but PrPd was strongly
expressed including amyloid plaques. Mink were also susceptible to BSE [44]. ...
snip...
please see full text and more here;
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Friday, April 19, 2013
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layperson
mom dod 12/14/97 hvCJD ‘confirmed’...just made a promise...tss
Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518
flounder9@verizon.net
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