From: Terry S. Singeltary Sr. Sent: Friday, December 14, 2012 1:22 PM To:
Terry S. Singeltary Sr. Subject: What is the risk of chronic wasting disease A
Qualitative Risk Assessment October 2012
www.defra.gov.uk
What is the risk of chronic wasting disease being introduced into Great
Britain?
A Qualitative Risk Assessment
October 2012
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Contents
Summary
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1
Background
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2
Hazard identification
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3
Risk Question
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6
Risk Assessment
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7
Terminology related to the assessed level of risk
............................................................. 7
Entry assessment
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7
Exposure assessment
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13
Consequence assessment
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18
Control and risk management options
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20
Conclusions
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20
References
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20
1
Summary
Chronic wasting disease (CWD) is a highly infectious transmissible
spongiform encephalopathy (TSE) that is circulating in the wild and farmed
cervid populations in North America. It is the only TSE to be prevalent in
free-ranging wild animal populations. A feature of CWD is its ability to spread
both directly and indirectly via the contaminated environment where it is able
to survive in a bio-available form for many years without any significant
decrease in infectivity. Eradication of the disease from wild and farmed or
managed cervid populations and the environment is extremely challenging and has
not yet been successful.
Currently, there have been no reported cases of CWD or other TSE in deer in
Great Britain (GB) or Europe. Given the consequences of CWD observed in North
America, it is imperative that GB remains free of the disease. This risk
assessment aims to assess the risk of CWD being imported into GB from North
America and consequently, consider the risk of exposure and infection within the
GB deer population. The assessment focuses on two main routes of entry including
importation of animal feed and movement of contaminated clothing, footwear and
equipment of tourists, deer hunters and British servicemen between affected
areas of North America and GB. It is important to highlight that there are
significant data gaps in this assessment. The main conclusions from this
assessment are:
*Several different animal feed products are imported into GB from North
America. These include processed pet foods and consignments of unfinished feed
ingredients for use in animal feed. The amount of imported feed, including pet
food, that contains cervid protein is unknown and identified as a significant
data gap. As non-ruminant animal feed may be produced with cervid protein (but
not from positive CWD animals) in the United States (US), there is a greater
than negligible risk that feed with cervid protein is imported from North
America into GB. There is, however, uncertainty associated with this
estimate.
*In areas of North America where CWD has been reported, given that CWD is
excreted in faeces, saliva, urine and blood, and survives in the environment for
several years where it is able to bind to the soil, there is a medium
probability that the environment (including soil) contains CWD.
*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 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.
*Once in GB, the use of animal feed is subject to the TSE Feed Ban and ABP
Regulations. In accordance with the current ban, farmed deer should not be
directly exposed to (i.e. feed) imported animal feed containing any PAP.
Therefore, assuming this ban is strictly adhered to, the risk of farmed and wild
deer being exposed to ruminant animal feed containing deer protein from North
America is considered negligible but with associated uncertainty. The
probability of a (wild) deer being exposed to CWD infected deer protein in
non-ruminant feed is considered to be greater than negligible but
uncertain.
*The pathways by which naïve deer in GB may be exposed to CWD contaminated
soil and prions on equipment and clothing from people arriving in GB from North
America are variable and highly uncertain. Given associated uncertainty, there
is a greater than negligible probability that a person could transfer CWD prions
from their contaminated equipment and/or clothing into deer habitat/environment,
particularly with respect to Roe deer (Capreolus capreolus) habitat but less so
for Chinese Water deer (Hydropotes inermis) habitat. Further, given the volume
of tourists and other travellers moving between North America and GB, there are
potentially multiple opportunities for CWD prions to be transferred from
equipment to the environment.
*None of the species affected by CWD in North America are present in GB.
For a British species to become infected with CWD given exposure will depend on
the dose and inherent susceptibility. Based on current scientific evidence Red
deer (Cervus elaphus elaphus) are susceptible to CWD, Fallow deer (Dama dama)
are likely to be less susceptible and Roe deer (Capreolus capreolus) have a gene
conferring susceptibility. Therefore, it is likely that given exposure to an
infectious dose of CWD, deer in GB could become infected with CWD.
*However, given that the amount of soil ingested is likely to be very
small, the probability of ingesting an infectious dose via this route is
considered negligible to very low. The probability of ingesting an infectious
dose via consumption of nonruminant feed is likely to be higher and may be very
low, with associated uncertainty.
Overall, the probability of importing CWD into GB from North America and
causing infection in British deer is uncertain but likely to be negligible to
very low via movement of deer hunters, other tourists and British servicemen and
very low via imported (nonruminant) animal feed. However, if it was imported and
(a) deer did become infected with CWD, the consequences would be severe as
eradication of the disease is impossible, it is clinically indistinguishable
from BSE infection in deer (Dagleish et al., 2008) and populations of wild and
farmed deer would be under threat.
SNIP...
Thus far, there have been no reported cases of CWD or other TSE in deer in
Great Britain (GB). This is based on surveys of wild and farmed red deer (Cervus
elaphus elaphus) (EFSA, 2011). Given the consequences of CWD observed in North
America, it is of high importance that GB remains free of the disease. Further,
as the clinical signs of CWD in deer are similar to those of deer experimentally
infected with bovine spongiform encephalopathy (BSE), all infected deer 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.
Possible routes of entry of CWD into GB include importation of animal feed
and the movement of tourists, hunters and British servicemen travelling between
affected areas in North America and GB. In regards to the latter route, soil
contaminated with CWD prions could be imported on people’s boots, clothing and
other equipment. This route of entry has been noted previously as a viable means
for the global dispersal of free-living organisms (Wilkinson, 2010).
SNIP...
This more widespread distribution may be due to enhanced surveillance but
also to natural migration of cervids and translocation of infected animals by
humans (EFSA, 2011). Within affected areas, the prevalence varies. In the
endemic area of Wyoming, for example, the prevalence of CWD in mule deer has
increased from approximately 11% in 1997 to 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...
Given its propensity to colonise the digestive tract, evidence suggests
the prion is excreted in faeces (Safar et al., 2008), urine and saliva
potentially leading to direct and indirect transmission between cervid species.
Indeed, the disease is transmitted horizontally with high efficiency and
circumstantial evidence suggests that environmental contamination with CWD
prions contributes to the maintenance of CWD in affected areas (Safar et al.,
2008). 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). The efficiency of CWD transmission is unparalleled among TSE diseases
(EFSA, 2011). Trifilo et al., (2007), using a murine tg mouse model, established
that CWD can be transmitted via the oral route. Indeed, the distribution of
PrPres in the orally infected mice (e.g. in the spleen and lymph nodes) mimicked
what has been reported in deer developing CWD via natural infection (Trifilo et
al., 2007). Modelling studies also support the theory that transmission of CWD
in deer herds is maintained by contact with a prion contaminated environment
(Almberg et al., 2011). Scavenging of CWD-infected carcasses provides another
route of releasing the prion into the environment and exposure of non-cervid
species (Sigurdson, 2008). This indirect transmission route is problematic as it
not only increases the basic reproductive number but also because there are very
few effective mitigation strategies for reducing the risk from indirect
transmission. This is due to the fact that the agent is extremely resistant in
the environment and able to bind to soil particles making eradication and
control of CWD a major obstacle in both farmed and free-ranging cervid
populations.
SNIP...
Sheep and cattle may be exposed to CWD via common grazing areas with
affected deer but so far, appear to be poorly susceptible to mule deer CWD
(Sigurdson, 2008). In contrast, cattle are highly susceptible to white-tailed
deer CWD and mule deer CWD in experimental conditions but no natural CWD
infections in cattle have been reported (Sigurdson, 2008; Hamir et al., 2006).
It is not known how susceptible humans are to CWD but given that the prion can
be present in muscle, it is likely that humans have been exposed to the agent
via consumption of venison (Sigurdson, 2008). Initial experimental research,
however, suggests that human susceptibility to CWD is low and there may be a
robust species barrier for CWD transmission to humans (Sigurdson, 2008). It is
apparent, though, that CWD is affecting wild and farmed cervid populations in
endemic areas with some deer populations decreasing as a result.
Thus far, CWD is restricted to North America with the exception of imported
infected animals into South Korea from Canada. Surveys of wild and farmed cervid
populations in the European Union between 2006 and 2010 did not identify any
TSEs (EFSA, 2011). As part of this survey, 601 farmed and 598 wild red deer
(Cervus elaphus elaphus) were tested (EFSA, 2010). These included clinical/sick
animals, fallen stock, healthy shot/slaughtered animals and road killed animals.
Based on the survey results, it can be concluded that the prevalence of CWD in
the EU is less than 0.5%. It is important, therefore, to ensure that the disease
is not introduced into Europe and establish within the EU wild and farmed cervid
population as the probability of being able to eradicate the disease would be
very small.
SNIP...
Entry assessment
The routes by which CWD may be introduced into GB from North America
include:
*Importation of live deer
*Importation of meat and other products derived from cervid species (e.g.
trophy items including antlers, semen)
*Importation of animal feed
*Hunters and other tourists and British servicemen travelling from affected
areas to GB with contaminated equipment (e.g. boots, clothing, knives)
Currently, according to the European Union Trade Control and Expert System
(TRACES) database, GB does not import live cervids, ‘other’ animal meat products
or raw hides and skins. This was the same conclusion drawn by EFSA (2004) who
stated GB does not import cervids or products from North America. Therefore, the
two routes which this assessment focuses on are:
1) importation of animal feed
2) importation of CWD prion on contaminated equipment and clothing/footwear
of hunters or other tourists and British servicemen
Importation of animal feed
Animal feed encompasses all feed fed to farmed livestock, horses, pets,
farmed fish, zoo and circus animals and also animals living freely in the wild.
Currently, legislation for animal feed relating to production, and labelling and
composition is harmonised at the EU level and, in GB, is the responsibility of
the Food Standards Agency (FSA). In addition, Defra is responsible for ABP
Regulations which includes pet food manufacturing regulation.
Pet food containing material of animal origin, according to EU Regulation
(EC) No. 142/2011 on Animal By-Products, must be derived from animals inspected
and passed as fit for human consumption prior to slaughter. Further, the
products are subject to strict microbiological criteria for Enterobacteriaceae
and Salmonella. Under the EU Regulation, imported pet food produced using
Category 3 processed animal proteins (PAP) must adhere to the same standards as
that produced within the EU. More specifically, the imported pet food must
satisfy the following criteria:
*The PAP must have been produced in accordance with the same requirements
as PAP for placing on the market in the EU
*The PAP must have been sampled and tested to satisfy certain
bacteriological criteria in accordance with the Regulations before release onto
the EU market
*The product must enter the EU under correct Health Certification
*The Health Certification signed by the veterinarian or official inspector
responsible for the rendering plant in the exporting country must verify that EU
standards of sourcing of animal by-products, processing and sampling are met for
each consignment.
These requirements apply to canned pet food, processed pet food other than
canned pet food, dog chews, raw pet food and flavouring innards.
According to TRACES, GB imports processed pet food from Canada and the
United States of America (USA). In November and December 2011, for example, GB
imported 201.375 kg processed cat and dog food from Canada and USA. There are a
limited number of processed pet food products made in the USA containing
(roasted) venison for the cat and dog food market that are available in GB (e.g.
Taste of the Wild pet food). Venison is high in iron content and considered a
good alternative meat product for pets with intolerance to certain meat
proteins. The specific amount of pet food products imported into GB from North
America containing deer protein is unknown but is likely to be a small
percentage of the overall amount of processed pet food imported.
Most other animal feeds imported are bulk consignments of ingredients,
mainly of vegetable origin, that are then processed for final product use in GB.
The TRACES database provides data on the varying and numerous animal feed
products that are imported into GB. Two datasets have been extracted previously
from TRACES providing information on animal feed importation. In January and
February 2012, a survey of feed materials and feed products imported into GB
from North America was conducted. All the products were exclusively of vegetable
origin and included, for example, citrus pulp, corn gluten, sunflower, beet
pulp, soil oil, and wheat feed. In a second survey, the amount of processed
animal proteins including fishmeal imported from USA to GB in 2010 and 2011 was
calculated. In 2010, 1359520 kilos of flours, meals and pellets of fish or meat
and unfit for human consumption was imported into GB; 8716 kilos were of
non-fish origin. In 2011, the amount of the same material imported decreased to
700818 kilos of which 8412 kilos were of non-fish origin.
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...
Movement of hunters, other tourists and British servicemen Probability that
the environment in North America is contaminated with CWD As outlined in Figure
1, there are 20 states and provinces in the USA and Canada where CWD has been
detected in farmed and wild cervids. These include: Alberta (Canada), Colorado,
Illinois, Kansas, Maryland, Minnesota, Missouri, Nebraska, New Mexico, New York,
North Dakota, Saskatchewan (Canada), South Dakota, Utah, Virginia, West
Virginia, Wisconsin and Wyoming. In these areas, the environment is likely to be
contaminated with CWD prions from direct excretion of the prion in various
bodily fluids of infected animals, and leaching of prions into the soil from
decaying carcasses of infected animals. A summary of the current studies on CWD
in faeces, urine, blood and other bodily fluids or organs is summarised in Table
1. Table 1: Summary of the studies on CWD prion excretion
SNIP...
remain intact after being passed through the digestive tract and,
therefore, are a viable Safar et al., (2008) source of infectivity in the
environment.
*CWD prions are excreted in the faeces of infected mule deer 7 to 11 months
prior to the onset of neurological signs (i.e. during the incubation period)
Tamguney et al. (2009) Saliva
*During studies of oral transmission using a murine tg mouse model, it was
observed that prior to and during clinical disease, serous and mucous glands
contained PrPres.
*Three naïve fawns were orally inoculated with 50ml of saliva from an
infected deer in 3 doses over a 3 day period. Eighteen months post inoculation,
CWD prions were detected in all 3 fawns during tonsil biopsy.
*Pooled saliva from five terminally CWD infected white-tailed deer was
inoculated into nine tg1536 mice. Eight of the nine mice developed disease
consistent with a TSE at 342 ± 109 days post inoculation suggesting infectious
prions are present in saliva of infected cervids. Trifilo et al., (2007)
Mathiason et al., (2006) Haley et al., (2009) Blood
*Two naïve white-tailed deer were inoculated intraperitoneally with 250 ml
of frozen citrated blood and a further fawn with an intravenous transfusion of
250 ml freshly citrated whole blood. After 18 months post inoculation, all three
fawns had CWD prions in their tonsils and retropharyngeal lymph node. Mathiason
et al., (2006) Urine
*Pooled urine from five terminally CWD infected white-tailed deer was
inoculated into nine tg mice. Two of the nine mice developed disease consistent
with a TSE at 370 and 376 days post inoculation suggesting infectious prions are
present in the urine of infected cervids but at a lower infectivity than other
bodily fluids such as saliva. Haley et al., (2009) Antler velvet
*Antlers are covered by a layer of skin, velvet, which is shed after an
increase in testosterone and ossification of antlers. CWD is present at low, but
detectable, amounts in antler velvet from infected elk. Angers et al., (2009)
It is clear from Table 1, that CWD is excreted in several different bodily
fluids and, as demonstrated in experimental studies, can be a source for onward
transmission to naïve animals. Infected carcasses decaying naturally in confined
areas can also lead to new CWD infections in naïve deer (Sigurdson, 2008). This
was proved, experimentally, by Miller et al., (2004) during a study of
environmental transmission. Specifically, 3 naïve mule deer were stocked in a
800m2 paddock in which a naturally infected mule deer had died and decomposed
approximately 1.8 years prior. In a second paddock, a further 3 naïve mule deer
were placed where infected mule deer had resided 2.2 years earlier and
contaminated the environment with their faeces (Miller et al., 2004). The
experiment was conducted in 3 replicates. In total, 3 out of 12 and 1 out of 9
deer were infected by being exposed to an infected decomposed carcass or
residual excreta, respectively.
The CWD prion has also been detected in water. Specifically, very low
levels (below infectious levels) were detected in a water sample from melting
winter snow-pack from an endemic area (Nichols et al., 2009). The data showed
persistence of CWD prions in water, accumulated levels of which, it is
hypothesised, may promote transmission within deer herds.
Once in the environment, TSE prions can bind to soil particles and remain
infectious (Saunder et al., 2010). Indeed, Johnson et al., (2006) demonstrated
that the diseaseassociated form of the prion protein can bind to all soil
mineral surfaces and is preserved in a bioavailable form. Further, in a later
study, Johnson et al., (2007) observed that prions bound to the soil mineral
montmorillonite (Mte) significantly enhanced disease penetrance and reduced the
incubation period compared to unbound prions. The reason why binding to Mte or
other soil components enhances transmissibility is unclear but it may provide
some protection for the prion in the gut against denaturation allowing more
agent to be absorbed by the animal (Johnson et al., 2007). Further, binding to
the soil particles maintains prions near the soil surface increasing the
probability of animal exposure (Russo et al., 2009).
In addition to the enhanced infectivity, prions can remain in the soil for
several years as the agents are resistant to inactivation by most chemical
agents, radiation and heat (Johnson et al., 2006). Seidel et al. (2007), for
example, demonstrated that scrapie agent (strain 263K) remains persistent in
soil over a period of at least 29 months and remains highly infectious to Syrian
hamsters in oral inoculation experiments. In Iceland during an epidemiological
investigation of scrapie, a TSE of sheep and goats, Georgsson et al., (2006)
reported that the scrapie agent survived on a farm for at least 16 years.
However, Russo et al., (2009) demonstrated experimentally that reactive soil
components such as manganese oxides may contribute to the inactivation process
of TSE prions in soil. The authors did not study CWD prion specifically but the
study highlights the complexity of the effect the inorganic and organic
constituents in soil may have on prion survival and infectivity.
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.
Movement of deer hunters, other outdoor tourists and British servicemen
between North America and GB
The probability a person comes into contact with CWD prions varies
depending upon their place of residence and/or their involvement with outdoor
pursuits (e.g. hunting). In this assessment, focus is given to the following
groups of people:
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.
Probable amount of CWD prions on contaminated boots and equipment
SNIP...
Given that a hunter or tourist walks in areas which are contaminated with
CWD, it is possible that they will collect soil on their boots and other
equipment. This likelihood will increase if the hunter has shot and handled a
CWD infected deer resulting in contamination of the hunting equipment (e.g.
knives) and their clothing and they subsequently arrive in GB with this
equipment, footwear and clothing. Further, the soles of hiking boots tend to
retain more soil than those of normal shoes. Wilkinson (2010), for example,
removed 0.1 g of soil from hiking boots after returning to GB from a 2-month
research visit to Canada. The amount of CWD prion in this amount of soil will
depend upon the density of CWD infected animals excreting prions into the
environment and the type of soil; CWD prion binds to clay soil, for example.
Animal mortality sites could also be hotspots of CWD prion given the highly
infectious nervous system matter entering into the environment and soil
(Saunders et al., 2010).
Exposure assessment
Importation of animal feed
Once in GB, the use of animal feed is subject to the TSE Feed Ban and ABP
Regulations. The BSE-related feed ban prohibits the feeding of PAP and gelatine
from ruminants to ruminants (including farmed deer) or non-ruminant farmed
animals. Further, ruminants must not be fed any animal protein or feedstuffs
which contains animal protein except for milk, milk-based products and
colostrum, eggs and egg products, gelatine from nonruminants and hydrolysed
proteins derived from non-ruminants or from ruminant hides and skins. Therefore,
in accordance with the current ban, farmed deer should not be directly exposed
to (i.e. feed) imported animal feed containing any PAP. Therefore, assuming this
ban is adhered to correctly the risk of farmed deer being exposed to animal feed
containing deer protein from North America is considered negligible but with
associated uncertainty. However, given that non-ruminant feed produced in the
USA may contain deer and elk PAP, it is theoretically possible that wild deer
may be exposed to deer protein in legally imported non-ruminant feed. For this
to occur, wild deer would need to access nonruminant feed (e.g. pig, fish and
chicken feed) on farms near their habitat. Alternatively, wild deer may be
exposed to CWD prion in the faeces of pets that have consumed and digested
imported, contaminated pet feed. The frequency in which these routes may occur
is unknown and is considered to be a greater than negligible risk with
associated uncertainty.
SNIP...
Wild deer
There are 6 species of wild deer residing in GB including: Red deer (Cervus
elaphus), Roe deer (Capreolus capreolus), fallow deer (Dama dama), muntjac
(Muntiacus reevesi), sika (Cervus nippon), and Chinese Water deer (Hydropotes
inermis). The British Deer Society implemented a survey in 2007 to ascertain the
distribution of these deer species across the UK. The survey provides the
presence of deer on a standard template of 10km grid squares (www.bds.org.uk ).
A further survey was conducted in 2011 of which the results will be published
later in 2012. The deer distribution as ascertained from the 2007 survey is
summarised in Figure 3.
SNIP...
Figure 3: Distribution of the six deer species in the UK in 2007 (British
Deer Society Deer Distribution Survey, http://www.bds.org.uk)/
It can be seen from Figure 3 that deer are widely distributed across the UK
with Roe deer being the most widespread. Chinese Water deer are the smallest
deer population with approximately 700 deer.
Deer hunters, particularly, are most likely to be in direct contact with
wild deer and their habitat compared to other tourists and returning GB
residents. During the stalking and/or hunting of deer, there is opportunity for
CWD prion on the hunter’s boots, clothing and/or equipment to be transferred to
the environment. The amount transferred will depend upon the measures taken to
remove soil etc from the equipment prior to stalking. Assuming that CWD prion is
transferred to the environment, there is an uncertain probability that a deer
will come into contact with the CWD prion.
Farmed and park deer
Deer farming is a relatively recent enterprise. There are two systems
currently used for managing enclosed deer: park and farm deer systems. In the
park system, deer are raised in a park type setting and allowed to roam freely
and may be provided with some supplemental feed. Farmed deer, in contrast,
following conventional agricultural practices and may be housed in the winter
and nutritional supplements are provided where necessary. In this farming
system, there are several categories including calf rearers, calf finishers,
breeder finishers and producer/processors (www.bdfpa.org). In 2011, according to
the June Agricultural census, there were approximately 21,000 farmed deer on
commercial agricultural holdings in England. The Economic Report on Scottish
Agriculture (2011) cited that within Scotland, Wales, England and Northern
Ireland there were 30,910 farmed deer. It is less likely that tourists, deer
hunters and British servicemen will come into contact with conventionally farmed
deer compared to park deer. The total park deer population in GB is unknown.
However, in 2005, based on annual population control culling of about 8,000
animals, it was estimated that there were approximately 40,000 park deer. These
deer are distributed across several parks (some of which are famous tourist
sites) where wild and/or exotic species of deer can roam and be viewed. These
are outlined in Table 2.
Table 2: Summary of parks in Great Britain where wild and/or exotic deer
roam (The British Deer Society, www.bds.org.uk)
It is evident from Table 2 that there are several locations in GB where
tourists and returning residents may come into contact with park deer and, in
doing so, potentially expose the deer to CWD on their contaminated clothing
and/or footwear. Further, given the volume of tourists and other travellers
moving between North America and GB, there are potentially multiple
opportunities for CWD prions to be transferred from clothing, boots and/or
equipment to the environment. It has been observed that multiple exposures to
low levels of CWD prions in the environment and increased infectivity of CWD
when prions are bound to the soil are influential factors in transmission (Anger
et al., 2009). Given the nature of their management, there is a restricted area
(or environment) in which park deer inhabit enabling them to have a potentially
higher probability of coming into contact with any CWD transferred to the
environment by a tourist or returning GB resident compared to wild deer in a
free-ranging environment.
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...SEE FULL TEXT ;
Saturday, August 4, 2012
Final Feed Investigation Summary - California BSE Case - July 2012
DOCKET-- 03D-0186 -- FDA Issues Draft Guidance on Use of Material From Deer
and Elk in Animal Feed; Availability
Date: Fri, 16 May 2003 11:47:37 –0500
EMC 1 Terry S. Singeltary Sr. Vol #: 1
Subject: MAD DEER/ELK DISEASE AND POTENTIAL SOURCES Date: Sat, 25 May 2002
18:41:46 -0700 From: "Terry S. Singeltary Sr." Reply-To: BSE-L To: BSE-L
8420-20.5% Antler Developer For Deer and Game in the wild Guaranteed
Analysis Ingredients / Products Feeding Directions
snip...
_animal protein_
BODE'S GAME FEED SUPPLEMENT #400 A RATION FOR DEER NET WEIGHT 50 POUNDS
22.6 KG.
snip...
_animal protein_
Ingredients
Grain Products, Plant Protein Products, Processed Grain By-Products, Forage
Products, Roughage Products 15%, Molasses Products, __Animal Protein Products__,
Monocalcium Phosphate, Dicalcium Pyosphate, Salt, Calcium Carbonate, Vitamin A
Acetate with D-activated Animal Sterol (source of Vitamin D3), Vitamin E
Supplement, Vitamin B12 Supplement, Riboflavin Supplement, Niacin Supplement,
Calcium Panothenate, Choline Chloride, Folic Acid, Menadione Soduim Bisulfite
Complex, Pyridoxine Hydorchloride, Thiamine Mononitrate, d-Biotin, Manganous
Oxide, Zinc Oxide, Ferrous Carbonate, Calcium Iodate, Cobalt Carbonate, Dried
Sacchoromyces Berevisiae Fermentation Solubles, Cellulose gum, Artificial
Flavors added.
===================================
MORE ANIMAL PROTEIN PRODUCTS FOR DEER
Bode's #1 Game Pellets A RATION FOR DEER F3153
GUARANTEED ANALYSIS Crude Protein (Min) 16% Crude Fat (Min) 2.0% Crude
Fiber (Max) 19% Calcium (Ca) (Min) 1.25% Calcium (Ca) (Max) 1.75% Phosphorus (P)
(Min) 1.0% Salt (Min) .30% Salt (Max) .70%
Ingredients
Grain Products, Plant Protein Products, Processed Grain By-Products, Forage
Products, Roughage Products, 15% Molasses Products, __Animal Protein Products__,
Monocalcium Phosphate, Dicalcium Phosphate, Salt, Calcium Carbonate, Vitamin A
Acetate with D-activated Animal Sterol (source of Vitamin D3) Vitamin E
Supplement, Vitamin B12 Supplement, Roboflavin Supplement, Niacin Supplement,
Calcium Pantothenate, Choline Chloride, Folic Acid, Menadione Sodium Bisulfite
Complex, Pyridoxine Hydrochloride, Thiamine Mononitrate, e - Biotin, Manganous
Oxide, Zinc Oxide, Ferrous Carbonate, Calcium Iodate, Cobalt Carbonate, Dried
Saccharyomyces Cerevisiae Fermentation Solubles, Cellulose gum, Artificial
Flavors added.
FEEDING DIRECTIONS Feed as Creep Feed with Normal Diet
INGREDIENTS
Grain Products, Roughage Products (not more than 35%), Processed Grain
By-Products, Plant Protein Products, Forage Products, __Animal Protein
Products__, L-Lysine, Calcium Carbonate, Salt, Monocalcium/Dicalcium Phosphate,
Yeast Culture, Magnesium Oxide, Cobalt Carbonate, Basic Copper Chloride,
Manganese Sulfate, Manganous Oxide, Sodium Selenite, Zinc Sulfate, Zinc Oxide,
Sodium Selenite, Potassium Iodide, Ethylenediamine Dihydriodide, Vitamin E
Supplement, Vitamin A Supplement, Vitamin D3 Supplement, Mineral Oil, Mold
Inhibitor, Calcium Lignin Sulfonate, Vitamin B12 Supplement, Menadione Sodium
Bisulfite Complex, Calcium Pantothenate, Riboflavin, Niacin, Biotin, Folic Acid,
Pyridoxine Hydrochloride, Mineral Oil, Chromium Tripicolinate
DIRECTIONS FOR USE
Deer Builder Pellets is designed to be fed to deer under range conditions
or deer that require higher levels of protein. Feed to deer during gestation,
fawning, lactation, antler growth and pre-rut, all phases which require a higher
level of nutrition. Provide adequate amounts of good quality roughage and fresh
water at all times.
PLEASE SEE FULL TEXT SUBMISSION ;
DOCKET-- 03D-0186 -- FDA Issues Draft Guidance on Use of Material From Deer
and Elk in Animal Feed; Availability
Date: Fri, 16 May 2003 11:47:37 –0500
EMC 1 Terry S. Singeltary Sr. Vol #: 1
2012 MAD COW FEED REPORT CALIFORNIA
oh God, this is going to be long. there are too many mad cow feed ban
warning letters and recalls of mad cow feed in commerce to list all of them here
now, but here are a few 1000s+ tonnages of banned mad cow protein in commerce
since the partial and voluntary mad cow feed ban was put into place August 4,
1997. this is not all by any means, just a few old warning letters in my files.
remember, .005 gram is lethal. let’s start from 2007, the last year that the FDA
et al publically published the mad cow feed ban warning letters, and then we
will go back year by year, to August 4, 1997, when the partial and voluntary mad
cow feed ban was put into effect...or rather inked on paper, because that’s
about all that happened...TSS
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
2006
Subject: MAD COW FEED RECALL USA SEPT 6, 2006 1961.72 TONS IN COMMERCE AL,
TN, AND WV
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
a) Dairy feed, custom, Recall # V-134-6;
b) Custom Dairy Feed with Monensin, Recall # V-135-6.
CODE
None. Bulk product
RECALLING FIRM/MANUFACTURER
Recalling Firm: Burkmann Feed, Greeneville, TN, by Telephone beginning on
June 28, 2006.
Manufacturer: H. J. Baker & Bro., Inc., Albertville, AL. Firm initiated
recall is complete.
REASON
Possible contamination of dairy feeds with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
1,484 tons
DISTRIBUTION
TN and WV
Subject: MAD COW FEED RECALLS ENFORCEMENT REPORT FOR AUGUST 9, 2006 KY, LA,
MS, AL, GA, AND TN 11,000+ TONS
Date: August 16, 2006 at 9:19 am PST
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II
______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-115-6
CODE
None
RECALLING FIRM/MANUFACTURER
Hiseville Feed & Seed Co., Hiseville, KY, by telephone and letter on or
about July 14, 2006. FDA initiated recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
Approximately 2,223 tons
DISTRIBUTION
KY
______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-116-6
CODE
None
RECALLING FIRM/MANUFACTURER
Rips Farm Center, Tollesboro, KY, by telephone and letter on July 14, 2006.
FDA initiated recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
1,220 tons
DISTRIBUTION
KY
______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-117-6
CODE
None
RECALLING FIRM/MANUFACTURER
Kentwood Co-op, Kentwood, LA, by telephone on June 27, 2006. FDA initiated
recall is completed.
REASON
Possible contamination of animal feed ingredients, including ingredients
that are used in feed for dairy animals, with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
40 tons
DISTRIBUTION
LA and MS
______________________________
PRODUCT
Bulk Dairy Feed, Recall V-118-6
CODE
None
RECALLING FIRM/MANUFACTURER
Cal Maine Foods, Inc., Edwards, MS, by telephone on June 26, 2006. FDA
initiated recall is complete.
REASON
Possible contamination of animal feed ingredients, including ingredients
that are used in feed for dairy animals, with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
7,150 tons
DISTRIBUTION
MS
______________________________
PRODUCT
Bulk custom dairy pre-mixes, Recall # V-119-6
CODE
None
RECALLING FIRM/MANUFACTURER
Walthall County Co-op, Tylertown, MS, by telephone on June 26, 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
87 tons
DISTRIBUTION
MS
______________________________
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 MI MAMMALIAN PROTEIN VOLUME OF PRODUCT IN
COMMERCE 27,694,240 lbs
Date: August 6, 2006 at 6:14 pm PST
PRODUCT
Bulk custom dairy feds manufactured from concentrates, Recall # V-113-6
CODE
All dairy feeds produced between 2/1/05 and 6/16/06 and containing H. J.
Baker recalled feed products.
RECALLING FIRM/MANUFACTURER
Vita Plus Corp., Gagetown, MI, by visit beginning on June 21, 2006. Firm
initiated recall is complete.
REASON
The feed was manufactured from materials that may have been contaminated
with mammalian protein.
VOLUME OF PRODUCT IN COMMERCE
27,694,240 lbs
DISTRIBUTION
MI
END OF ENFORCEMENT REPORT FOR AUGUST 2, 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
###
Subject: MAD COW FEED RECALL KY VOLUME OF PRODUCT IN COMMERCE ?????
Date: August 6, 2006 at 6:19 pm PST
PRODUCT
Bulk custom made dairy feed, Recall # V-114-6
CODE
None
RECALLING FIRM/MANUFACTURER
Burkmann Feeds LLC, Glasgow, KY, by letter on July 14, 2006. Firm initiated
recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak, which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
?????
DISTRIBUTION
KY
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
###
Subject: MAD COW FEED BAN WARNING LETTER ISSUED MAY 17, 2006
Date: June 27, 2006 at 7:42 am PST
Public Health Service
Food and Drug Administration
New Orleans District 297 Plus Park Blvd. Nashville, TN 37217
Telephone: 615-781-5380 Fax: 615-781-5391
May 17, 2006
WARNING LETTER NO. 2006-NOL-06
FEDERAL EXPRESS OVERNIGHT DELIVERY
Mr. William Shirley, Jr., Owner Louisiana.DBA Riegel By-Products 2621 State
Street Dallas, Texas 75204
Dear Mr. Shirley:
On February 12, 17, 21, and 22, 2006, a U.S. Food & Drug Administration
(FDA) investigator inspected your rendering plant, located at 509 Fortson
Street, Shreveport, Louisiana. The inspection revealed significant deviations
from the requirements set forth in Title 21, Code of Federal Regulations, Part
589.2000 [21 CFR 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; products being manufactured and distributed by your facility are
misbranded within the meaning of Section 403(a)(1) [21 USC 343(a)(1)] of the
Federal Food, Drug, and Cosmetic Act (the Act).
Our investigation found you failed to provide measures, including
sufficient written procedures, to prevent commingling or cross-contamination and
to maintain sufficient written procedures [21 CFR 589.2000(e)] because:
You failed to use clean-out procedures or other means adequate to prevent
carryover of protein derived from mammalian tissues into animal protein or feeds
which may be used for ruminants. For example, your facility uses the same
equipment to process mammalian and poultry tissues. However, you use only hot
water to clean the cookers between processing tissues from each species. You do
not clean the auger, hammer mill, grinder, and spouts after processing mammalian
tissues.
You failed to maintain written procedures specifying the clean-out
procedures or other means to prevent carryover of protein derived from mammalian
tissues into feeds which may be used for ruminants.
As a result . the poultry meal you manufacture may contain protein derived
from mammalian tissues prohibited in ruminant feed. Pursuant to 21 CFR
589.2000(e)(1)(i), any products containing or may contain protein derived from
mammalian tissues must be labeled, "Do not feed to cattle or other ruminants."
Since you failed to label a product which may contain protein derived from
mammalian tissues with the required cautionary statement. the poultry meal is
misbranded under Section 403(a)(1) [21 USC 343(a)(1)] of the Act.
This letter is not intended 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 these violations, and you should establish a system whereby violations
do not recur. Failure to promptly correct these violations may result in
regulatory action, such as seizure and/or injunction, without further notice.
You should notify this office in writing within 15 working days of
receiving this letter, outlining the specific steps you have taken to bring your
firm into compliance with the law. Your response should include an explanation
of each step taken to correct the violations and prevent their recurrence. If
corrective action cannot be completed within 15 working days, state the reason
for the delay and the date by which the corrections will be completed. Include
copies of any available documentation demonstrating corrections have been made.
Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S.
Food and Drug Administration, 2424 Edenborn Avenue, Suite 410, Metairie,
Louisiana 70001. If you have questions regarding any issue in this letter,
please contact Mr. Rivero at (504) 219-8818, extension 103.
Sincerely,
/S
Carol S. Sanchez Acting District Director New Orleans District
2005
Subject: MAD COW FEED BAN WARNING LETTER December 21, 2005
Date: January 10, 2006 at 7:18 am PST Public Health Service Food and Drug
Administration
Kansas City District Southwest Region 11630 West 80th Street Lenexa, Kansas
66214-3340
December 21, 2005
CERTIFIED MAIL RETURN RECEIPT REQUESTED
WARNING LETTER
Ref. KAN 2006-08
Mr. Paul Rasmussen, President Gold Eagle Cooperative Board of Directors
1145 Birch Ave Corwith, IA 50430
Dear Mr. Rasmussen:
An investigator from our office conducted two inspections of your animal
feed manufacturing operations at 415 N. Locust St., Goldfield, Iowa on August 23
and August 25 -26, 2005. During these inspections, a significant deviation from
the requirements set forth in Title 21, Code of Federal Regulations (CFR), Part
589 .2000 [21 CFR 589 .2000] - Animal Proteins Prohibited in Ruminant Feed, was
identified . The regulation is intended to prevent the establishment and
amplification of Bovine Spongiform Encephalopathy (BSE). Our investigation found
a failure to label one of your products, "ISLACT - IS LACTATION," a swine feed,
with the statement "Do Not Feed to Cattle or Other Ruminants," as required by 21
CFR 589 .2000(d) . Although your swine feed is not formulated with protein
derived from mammalian tissues as defined in 21 CFR 589 .2000(a)(1), which is
prohibited in ruminant feed, your production practices may cause the finished
product to contain such material. Our investigator found that your firm does not
have a strategy for sequencing feeds and does not flush or otherwise clean
shared production equipment between the manufacture of poultry feed formulated
with protein derived from mammalian tissues and swine feed formulated without
such material . As a result, swine feed may acquire protein derived from
mammalian tissue from poultry feed residue remaining on the shared production
equipment. Your failure to label your "ISLACT - IS LACTATION" swine feed with
the statement "Do Not Feed to Cattle or Other Ruminants" causes it to be
misbranded under section 403(a)(1) of the Act.
The above is not intended to be an all-inclusive list of deficiencies at
your facility. As a manufacturer of animal feed, you are responsible for
ensuring that your overall operation and the products you manufacture and
distribute comply with the law.
You should take prompt action to correct this violation and establish a
system whereby such violations do not recur. Failure to promptly correct this
violation may result in regulatory action, such as seizure and/or injunction,
without further notice.
You should notify this office in writing of the steps you have taken to
bring your firm into compliance with the law within fifteen (15) working days of
receiving this letter. Your response should include an explanation of each step
being taken to correct the violation and prevent its recurrence. If corrective
action cannot be completed within fifteen (15) working days, state the reason
for the delay and the date by which the corrections will be completed. Please
include copies of any available documentation demonstrating that corrections
have been made.
Please send your reply to the Food and Drug Administration, Attention:
Ralph Gray, Compliance Officer, 11630 West 80th Street, Lenexa, KS 66214-3340.
Sincerely, /s/
C.R. Pendleton for John W. Thorsky District Director Kansas City District
2005
-------- Original Message --------
Subject: MAD COW FEED BAN WARNING LETTER Petrolia TEXAS
Date: Tue, 8 Feb 2005 08:30:48 –0600
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@LISTSERV.KALIV.UNI-KARLSRUHE.DE
##################### Bovine Spongiform Encephalopathy
#####################
Public Health Service Food and Drug Administration
Dallas District 4040 North Central Expressway Dallas, Texas 75204-3145
January 12, 2005
Ref: 2005-DAL-WL-11
WARNING LETTER
CERTIFIED MAIL RETURNED RECEIPT REQUESTED
Mr. William L. Brown, Owner Brown Cattle Company 1 Feed Lot Road P.O. Box
281 Petrolia, TX 76377
Dear Mr. Brown:
An inspection of your ruminant feeding operation located at 1 Feed Lot
Road, Petrolia, Texas, was conducted on August 24 and September 8, 2004 by an
Investigator from the Food and Drug Administration (FDA). The inspection found
significant deviations from the requirements set forth in Title 21, Code of
Federal Regulations, Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed
(21 CFR 589.2000). This regulation is intended to prevent the establishment and
amplification of Bovine Spongiform Encephalopathy (BSE).
Our inspection revealed that you feed prohibited material, as defined by 21
CFR 598.2000(a), to ruminants. This prohibited material consists of human food
processing waste, which is derived from corn dog manufacturing and contains hot
dogs and corn dogs. Inspected meat products that have been cooked and offered
for human food and further heat processed for animal feed are not prohibited
material. This is more fully described in Guidance for Industry 76, which was
previously provided to your firm. The human food processing waste you are using
has not been further heat processed. The failure to further heat process this
material causes the feed to be adulterated within the meaning of Section
402(a)(2)(C)(i) of the Federal, Food, Drug, and Cosmetic Act.
During our previous inspection on January 17, 2002, copies of the BSE
Guidance documents 69, 70 and 76 and 21 CFR 589.2000, the BSE regulation, were
provided to and discussed with you.
Failure to correct these violations may result in FDA taking regulatory
action without further notice including, but not limited to, seizure and/or
injunction.
It is necessary for you to take action on this matter now. Please notify
this office in writing within fifteen (15) working days from the date you
received this letter. Your response should specifically identify the actions you
are taking to correct the violations and provide specific timeframes for
achieving compliance. Also, as part of your written response, you should provide
information regarding the current feeding practices followed at your facility
and information pertaining to the planned marketing of your animals. Your reply
should be sent to Edwin Ramos, Compliance Officer, at the above stated address.
If you have any questions concerning the stated matters, you may contact Mr.
Ramos at 214-253-5218.
Sincerely,
/s/
Michael A. Chappell
Dallas District Director
TSS
######### https://listserv.kaliv.uni-karlsruhe.de/warc/bse-l.html
##########
2004
-------- Original Message --------
Subject: ''HOLY MAD COW'', USA NOW POSTING MAD COW FEED BAN WARNING LETTERS
AGAIN WITH SICK SICK COWS
Date: Tue, 20 Apr 2004 08:31:34 –0500
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de
######## Bovine Spongiform Encephalopathy #########
Public Health Service Food and Drug Administration
Cincinnati District Office Central Region 6751 Stager Drive Cincinnati, OH
45237-3097 Telephone: (513) 679-2700 FAX: (513) 679-2771
VIA FEDERAL EXPRESS
April 8, 2004
Mr. Thomas S. Hurst, Jr., Owner Bardstown Mill, Inc. 204 W. Muir St
Bardstown, KY 40004
WARNING LETTER CIN-04-20830
On January 7,21-22, 2004, a Food and Drug Administration investigator
conducted an inspection of your feed mill located at 204 W. Muir St., Bardstown,
KY 40004. The inspection revealed significant deviations from the requirements
set forth in Title 21, Code of Federal Regulations, Part 589.2000 - Animal
Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the
establishment and amplification of Bovine Spongiform Encephalopathy (BSE).
Our inspection found your firm failed to label feeds or mark the invoices
of feeds that contain, or may contain, prohibited materials with the required
cautionary statement Do Not Feed To Cattle Or Other Ruminants . We suggest this
statement be distinguished by different type size or color or other means of
highlighting the statement so it is easily noticed by the purchaser.
The deviations from the BSE regulations, as noted above, cause products
being manufactured and distributed by your facility to be misbranded within the
meaning of Section 403(a)(1) of the Federal Food Drug and Cosmetic Act (the
Act).
This letter is not intended to be an all-inclusive list of deficiencies at
your facility. As a manufacturer of materials intended for animal feed use, you
are responsible for assuring that your overall operation and the products you
manufacture and distribute are in compliance with the law. We have enclosed a
copy of the FDA s Small Entity Compliance Guide to assist you with complying
with the regulation. You should take prompt action to correct these violations,
and you should establish a system whereby violations do not recur. Failure to
promptly correct these violations may result in regulatory action without
further notice. Such actions include seizure and/or injunction.
You should notify this office in writing within fifteen (15) working days
of the receipt of this letter of the steps you have taken to bring your firm
into compliance with the law. Your response should include an explanation of
each step being taken to correct the CGMP violations and prevent their
recurrence.
If corrective action cannot be completed within 15 working days, state the
reason for the delay and the date by which the corrections will be completed.
Include copies of any available documentation demonstrating that corrections
have been made.
Your response should be directed to Stephen J. Rabe, Compliance Officer at
the address listed above.
Sincerely,
/s/
Carol A. Heppe District Director Cincinnati District
Attachment: Small Entity Compliance Guide
Public Health Service Food and Drug Administration
Cincinnati District Office Central Region 6751 Steger Drive Cincinnati, OH
45237-3097 Telephone: (513) 679-2700 FAX: (513) 679-2771
April 8, 2004
WARNING LETTER via Federal Express
CIN-04-201679
Ralph K. Halter, President Halter Feed & Grain, Inc. 11501 Baywood
Street Robertsville, OH 44670
Dear Mr. Halter:
An inspection of your unlicensed feed mill, Halter Feed & Grain, Inc.,
located at 405 Tremont Ave. SW, Massilon, OH 44646, conducted by Food and Drug
Administration investigators, on 11/21 - 12/03/2003, found significant
deviations from the requirements set forth in Title 21, Code of Federal
Regulations, Part 589.2000 (21 CFR 589.2000) - Animal Proteins Prohibited in
Ruminant Feed. This regulation is intended to prevent the establishment and
amplification of Bovine Spongiform Encephalopathy (BSE). Such deviations cause
products being manufactured and distributed by your facility to be adulterated
within the meaning of Section 402(a)(4) and misbranded within the meaning of
Section 403(f) of the Federal Food, Drug, and Cosmetic Act (the Act).
Our investigator found the following violations of 21 CFR 589.2000:
1) failure to label products that contain or may contain prohibited
materials with the caution statement - Do not feed to cattle or other ruminants
, as required by 21 CFR 589.2000(d)(1);
2) failure to establish and maintain written procedures, including
clean-out and flushing procedures, to avoid commingling and cross-contamination
of common equipment, as required by 21 CFR 589.2000(e)(1)(iv);
3) failure to maintain records sufficient to track prohibited materials
throughout their distribution in that you do not always document the customer
name or address for the sale and distribution of feeds containing meat and bone
meal, as required by 21 CFR 589.2000(d)(1).
The above is not intended as an all-inclusive list of CGMP violations. As a
manufacturer of materials intended for animal feed use, you are responsible for
assuring that your overall operation and the products you manufacture and
distribute are in compliance with the law.
You should notify this office, in writing, within fifteen (15) working days
of the receipt of this letter of the present operational status of this
facility. We understand that this facility may have been put out of production
by a fire that occurred on January 16, 2004. Since there is the possibility that
the facility will again be operational, you should include an explanation of
each step that will be taken to correct the violations and prevent their
recurrence.
Your response should be directed to Charles S. Price Compliance Officer,
U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237-3097.
If you have any questions regarding this letter, you may call Mr. Price at
telephone (513) 679-2700 extension 165.
Sincerely,
/s/
Carol A. Heppe District Director Cincinnati District
cc: George H. Snyder, Manager Halter Feed & Grain, Inc. P.O. Box 821
Massillon, OH 44648
snip...rest was antibiotic warning letters cause the animals were too sick
to slaughter...tss
Public Health Service Food and Drug Administration
Dallas District 4040 North Central Expressway Dallas, Texas 75204-3145
June 15, 2004
Ref: 2004-DAL-WL-18
WARNING LETTER
CERTIFIED MAIL RETURNED RECEIPT REQUESTED
Mr. Patrick O Ray, CEO & President Specialty Brands, Inc. P.O. Box
51467 Ontario, CA 91761-1057
Dear Mr. O Ray:
An inspection of your food manufacturing facility located at 601 E. 3rd
Street, Lampasas, Texas, was conducted on February 26 and March 1, 2004 by
Investigators from the Food and Drug Administration (FDA). The inspection found
significant deviations from the requirements set forth in Title 21, Code of
Federal Regulations, Section 589.2000 - Animal Proteins Prohibited in Ruminant
Feed (21 CFR 589.2000). This regulation is intended to prevent the establishment
and amplification of Bovine Spongiform Encephalopathy (BSE).
Our inspection revealed that your firm sells its reduction stream waste for
use as animal feed and that it contracted with [redacted] to dispose of this
manufacturing process stream waste. [redacted] used this process stream waste as
animal feed for ruminants.
At the close of the inspection, a list of inspectional observations (FDA
483) was issued to your firm and discussed with Mr. Anthony E. Rocz, Plant
Manager. The following violation was observed during the inspection:
Products that contain protein derived from mammalian tissues and that are
intended for use in animal feed must be labeled with the cautionary statement,
Do not feed to cattle or other ruminants, as required by 21 CFR 589.2000(d)(1).
For example, your firm manufactures Mexican specialty food products such as
tortillas, taquitos, and burritos that contain beef. The production process
stream waste includes ground corn, product shells, and filling material, it is
then placed in a transportable bin for disposal by feeding to livestock. This
transportable waste bin did not bear the cautionary statement Do Not Feed to
Cattle or Other Ruminants.
Because your manufacturing stream waste did not bear this cautionary
statement, these products are misbranded within the meaning of section 403(a)(1)
of the Federal Food, Drug, and Cosmetic Act.
You should know that this serious violation of the law may result in FDA
taking regulatory action without further notice to you. These actions include,
but are not limited to, seizure and/or injunction.
We are in receipt of a letter from Mr. Anthony E. ROCZ, Plant Manager,
dated March 2, 2004, in which he stated that your factory was under a contract
with [redacted] to remove and dispose of the production stream waste generated
at the factory since April 15, 2003. Our investigators conveyed to Specialty
Brands, Inc., on February 24, 2004, that the disposal container was not properly
labeled to indicate that the material is not to be fed to cattle or other
ruminants in accordance with the BSE regulation. On February 26, 2004, our
investigators returned to your plant and conveyed to Mr. Rocz that earlier that
morning they observed cattle consuming the manufacturing stream waste supplied
by your firm to [redacted] The practice of supplying process stream waste to
[redacted] was indefinitely suspended on February 26, 2004. At that time, an
alternative waste removal service was obtained to dispose of the process stream
waste in a sanitary landfill facility and each load would be logged, a manifest
detailing the pounds of process waste disposed would be generated, and a
certification of proper disposal is to be provided for the record. This
alternative stream waste disposal process appears to be acceptable. Your letter
also states that your corporate Food Safety and Quality Assurance department is
in the process of drafting a corporate wide policy to ensure that all of your
factories are in compliance with the BSE regulation.
It is necessary for you to take prompt action on this matter now. Please
notify this office in writing within fifteen (15) working days from the date you
receive this letter of the specific actions you have taken to prevent the
recurrence of the violations, and when those actions were taken or will be taken
at your other corporate facilities having similar disposal plans. Your reply
should be sent to Edwin Ramos, Compliance Officer, at the above stated address.
If you have any questions concerning this letter, you may contact Mr. Ramos at
214-253-5218.
Sincerely,
/s/
Michael A. Chappell Dallas District Director
cc: Specialty Brands, Inc. Mr. Anthony E. Rocz, Plant Manager 601 E Third
Street Lampasas, TX 76550-2903
Public Health Service Food and Drug Administration
Dallas District 4040 North Central Expressway Dallas, Texas 75204-3145
June 10, 2004
Ref: 2004-DAL-WL-17
WARNING LETTER
CERTIFIED MAIL RETURNED RECEIPT REQUESTED
Mr. Jack Chapman, Owner Chapman Ranch 11071 CR 1255 Lampasas, TX 76550
Dear Mr. Chapman:
An inspection of your ruminant feeding operation located at 11071 CR 1255,
Lampasas, Texas, was conducted on February 26 and March 1, 2004 by Investigators
from the Food and Drug Administration (FDA). The inspection found significant
deviations from the requirements set forth in Title 21, Code of Federal
Regulations, Section 589.2000 - Animal Proteins Prohibited in Ruminant Feed (21
CFR 589.2000). This regulation is intended to prevent the establishment and
amplification of Bovine Spongiform Encephalopathy (BSE).
Our inspection revealed that you feed prohibited material, as defined by 21
CFR 589.2000(a), to ruminants. This prohibited material consists of
manufacturing process stream waste from [redacted] a manufacturer of products
such as fully cooked tacos, burritos, and taquitos that contain beef. This
manufacturing process stream waste contains meat products that have been cooked
and offered for human food but that have not been further heat processed for
feed. This failure to further heat process the material causes the feed to be
adulterated under section 402(a)(2)(C)(i) because it contains an unapproved food
additive (i.e., the meat products that have not been further heat processed for
feed).
At the close of the inspection, copies of the BSE Guidance documents 69, 70
and 76 were provided to you and further discussed. Also, you previously received
a copy of 21 CFR 589.2000, the BSE regulation, which was again explained in more
specific detail. You should know that this serious violation of the law may
result in FDA taking regulatory action without further notice to you. These
actions include, but are not limited to, seizure and/or injunction.
It is necessary for you to take action on this matter now. Please send a
written response to this office within fifteen (15) working days from the date
you receive this letter. Your response should specifically identify the actions
you are taking to correct the violations and provide specific timeframes for
achieving compliance. Also, as part of your written response, you should provide
information regarding the current feeding practices followed at your facility
and information pertaining to the planned marketing of your animals. Your reply
should be sent to Edwin Ramos, Compliance Officer, at the above stated address.
If you have any questions concerning this letter, you may contact Mr. Ramos at
214-253-5218.
Sincerely,
/s/
Michael A. Chappell Dallas District Director
horizonal rule
Public Health Service Food and Drug Administration
Atlanta District Office 60 8th Street, N.E. Atlanta, Georgia 30309
June 10, 2004
VIA FEDERAL EXPRESS
WARNING LETTER (04-ATL-13)
M. Dennis Burroughs President B & G Seed Company 591 Beck Road Hull,
Georgia 30646
Dear Mr. Burroughs:
An inspection of your feed mill was conducted by a Food and Drug
Administration (FDA) investigator on March 30, 2004. Our investigator determined
that you manufacture various products, including ruminant feeds, which are
animal feeds within the meaning of section 201(w) of the Federal Food, Drug, and
Cosmetic Act (the Act}. The inspection revealed significant deviations from the
requirements set forth in Title 21, Code of Federal Regulations (21 CFR), Part
589.2000 --Animal-Proteins Prohibited in Ruminant Feed. This regulation is
intended to prevent the establishment and amplification of Bovine Spongiform
Encephalopathy (BSE). The deviations cause the feed being manufactured and
distributed by your facility to be misbranded within the meaning of sections
403(a)(1) of the Act.
The inspection revealed that not all of your feeds that contain protein
derived from mammalian tissues and that are intended for use in animal feed
(prohibited material) were labeled with the statement Do not feed to cattle or
other ruminants, as required by 21 CFR 589.2000(d)(1) and (c)(1)(i). An example
is your B & G Pig Grower. In addition, you have routinely provided scrap or
salvage dog food containing prohibited material to be used as pig feed that was
not labeled with the required statement. In the case of bulk feed ingredients,
the statement could appear on the placard and invoice that accompany the
shipment. The lack of the required statement causes these feeds to be misbranded
as defined in section 403(a)(1) of the Act.
Our investigator also noted that you had failed to provide for adequate
measures to avoid commingling or cross-contamination of products that contain or
may contain prohibited material into feeds that may be used for ruminants, as
required under 21 CFR 589.2000(e)(1)(iii). You also failed to establish written
procedures for separating products which may contain prohibited material from
all other protein products from the time of receipt until the time of shipment,
as required under 21 CFR 589.2000(e)(1)(iv).
The above is not intended as an all-inclusive list of violations at your
firm. As a manufacturer of animal feeds, you are responsible for ensuring that
your overall operation and the products you manufacture and distribute are in
compliance with the law. We have included a copy of the FDA Guidance for
Industry 68 - Small Entities Compliance Guide - Protein Blenders, Feed
Manufacturers, and Distributors.
You should take prompt action to correct the above violations, and you
should establish procedures whereby such violations do not recur. Failure to
promptly correct these violations may result in regulatory action without
further notice, such as seizure and/or injunction.
You should notify this office, in writing, within fifteen (15) working days
of the receipt of this letter of the steps you have taken to bring your firm
into compliance with the law. Your response should include an explanation of
each step being taken to correct the violations and prevent their recurrence. We
do note that you initiated some corrective actions during the inspection,
including a feed recall and printing new labels. If corrective action cannot be
completed within 15 working days, state the reason for the delay and date by
which the corrections will be completed. Include copies of any available
documentation demonstrating that corrections have been made. Your response
should be directed to Philip S. Campbell, Compliance Officer, at the address
noted in the letterhead.
Sincerely,
/s/
Mary Woleske, Director Atlanta District
TSS
-------- Original Message --------
Subject: MAD COW FEED BAN WARNING LETTERS JULY 20, 2004 USA
Date: Tue, 20 Jul 2004 09:14:11 –0500
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de
######## Bovine Spongiform Encephalopathy #########
USA BSE/TSE TRIPLE FIREWALLS SEEPING IN 2004...TSS
Public Health Service Food and Drug Administration
San Francisco District 1431 Harbor Bay Parkway Alameda, CA 94502-7070
Telephone: 510/337-6700
VIA HAND DELIVERY
Our Reference No. 1000123954
June 23, 2004
Ronald M. Foster, Manager Randall C. Boyce, Manager Trevor O. Foster,
Manager George P. Foster, Manager Fresno Farming LLC P.O. Box 457 1000 Davis
Street Livingston, California
WARNING LETTER
Dear Mssrs. Foster, Boyce, Foster, and Foster:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your
medicated animal feed mill operation, Fresco Farming LLC, located in Traver,
California from April 14, 2004 through May 6, 2004, and found 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. The regulation is intended to prevent the establishment and
amplification of Bovine Spongiform Encephalopathy (BSE). Because you failed to
follow this rule, products you manufactured and distributed are adulterated
within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic
Act (the Act) because they were prepared, packed, or held under insanitary
conditions whereby they may have been rendered injurious to health.
Our inspection found the following violations of 21 C.F.R. 589.2000:
1. Failure to provide for measures to avoid commingling or
cross-contamination of products that contain or may contain protein derived from
mammalian tissues into animal protein or feeds that may be used for ruminants to
comply with 21 C.F.R. 589.2000(e)(1)(iii).
* Your firm uses a vacuum system to clean up spilled product in the tunnel
area. This tunnel area houses the two receiving conveyor systems and the
elevators for the two conveyor systems. When product, including ruminant meat
and bone meal, is spilled onto the floor of this area, the spilled product is
vacuumed up by the vacuum system and, via a discharge hose, was placed into a
conveyor system that your firm had designated as free of ruminant meat and bone
meal. Your firm admitted that it was unaware of the vacuum system discharging
into the conveyor systems designated as free of ruminant meat and bone meal and
that this had been in place since April 2003. Your firm remedied this problem
during FDA s April/May 2004 inspection by removing the discharge hose connection
to the conveyer system that your firm had designated as free of ruminant meat
and bone meal . * Your firm uses a dust collection system that pulls dust from
systems that receive both ruminant meat and bone meal and feed ingredients
intended for ruminants. This dust system then discharged collected product back
into the two conveyor systems via a cross connection, thereby making it likely
that ruminant meat and bone meal became commingled with ruminant feed
ingredients. Your firm admitted that it was unaware of the cross connection and
that it had been in place since April 2003. Your firm removed the cross
connection during FDA s April/May 2004 inspection.
2. Failure to maintain written procedures specifying the clean-out
procedure or other means, and specifying the procedures for separating products
that contain or may contain protein derived from mammalian tissue from all other
protein products from the time of receipt until the time of shipment, to comply
with 21 C.F.R. 589.2000(e)(1)(iv). This observation was also noted during FDA s
July/August 2003 inspection of your firm.
* There are no written procedures for separating products that contain
prohibited material from ingredients used in ruminant feeds from the time of
receipt until the time of shipment. * The written procedure for cleaning out or
flushing equipment after mixing feeds containing prohibited material was not
adequate to prevent contamination of ruminant feed with prohibited material.
3. Failure to maintain records sufficient to track materials that contain
protein derived from mammalian tissues throughout their receipt, processing, and
distribution to comply with 21 C.F.R. 589.2000(e)(1)(i). This observation was
also noted during FDA s July/August 2003 inspection of your firm.
* Specifically, your firm has failed to develop and implement complete
written procedures to separate ruminant meat and bone meal from feed ingredients
intended for ruminants from the time of receipt until the time of distribution.
The written procedures that do exist fail to address the use of equipment common
to ruminant meat and bone meal and ruminant feed ingredients.
The above is not intended to be an all-inclusive list of deficiencies at
your facility. As a manufacturer of materials intended for use as animal feed,
you are responsible for assuring that your overall operation and the products
you manufacture and distribute are in compliance with the law. You should take
prompt action to correct these violations, and you should establish a system
whereby such violations do not recur. Failure to promptly correct these
violations may result in regulatory action without further notice, such as
seizure and/or injunction.
You should notify this office in writing within fifteen (15) working days
of receiving this letter of the steps you have taken to bring your firm into
compliance with the law. Your response should include an explanation of each
step being taken to correct the violations and prevent their recurrence. If
corrective actions cannot be completed in fifteen (15) working days, state the
reason for the delay and the date by which the corrections will be completed.
Include copies of any available documentation demonstrating that corrections
have been made.
Please send your reply to the U.S. Food and Drug Administration, Attention:
Ms. Harumi Kishida, Compliance Officer, 1431 Harbor Bay Parkway, Alameda,
California 94502-7070. If you have questions regarding this letter, please
contact Ms. Kishida at (510) 337-6824.
Sincerely,
/s/
CD Moss, Acting DD for Barbara J. Cassens District Director San Francisco
District
cc: VIA CERTIFIED MAIL RETURN RECEIPT REQUESTED C. Michael Blasco, Feed
Mill Manager Fresno Farming LLC P.O. Box 430 Traver, California 93673
Public Health Service Food and Drug Administration
Chicago District 550 West Jackson Blvd., 15th Floor Chicago, Illinois 60661
Telephone: 312-353-5863
July 12, 2004
WARNING LETTER CHI-16-04
CERTIFIED MAIL RETURN RECEIPT REQUESTED
Mr. Donald E. Hamilton, President/Owner Illini Feeds, Inc. P.O. Box 86,
1145 State Hwy. 94 Aledo, Illinois 61231
Dear Mr. Hamilton:
On February 19 and 20, 2004, the Food and Drug Administration (FDA)
conducted an inspection of your animal feed handling facility located at 1145
State Highway 94, Aledo, Illinois. The inspection found significant deviations
from the requirements set forth in Title 21, Code of Federal Regulations, Part
589.2000 (21 CFR 589.2000) - Animal Proteins Prohibited in Ruminant Feed. This
regulation is intended to prevent the establishment and amplification of Bovine
Spongiform Encephalopathy (BSE). The deviations cause the swine feed
manufactured by your facility to be misbranded within the meaning of Section
403(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).
Our investigation found that salvaged pet food containing prohibited
material was added as an ingredient to the swine products manufactured at your
facility. During the inspection, our investigator found that you failed to label
your non-ruminant products with the required caution statement - Do not feed to
cattle or other ruminants. [21 CFR 589.2000(d)(1)]
The above is not intended to be an all-inclusive list of violations. As a
manufacturer of materials intended for use in animal feed, you are responsible
for assuring that your overall operation and the products you manufacture and
distribute are in compliance with the law.
You should take prompt action to correct this violation, and you should
establish a system whereby such violations do not recur. Failure to promptly
correct this violation may result in regulatory action without further notice,
such as seizure and/or injunction.
During the inspection, you told the investigator that you would put the
required cautionary statement on your products that contain prohibited material,
and maintain tracking documents for all incoming ingredients, including animal
proteins prohibited in ruminant feed. Please notify this office in writing
within 15 working days of receiving this letter of any further steps you have
taken to assure that your firm is in compliance with the law. Your response
should also include an explanation of each step taken to correct the violations,
and prevent their recurrence. Please include copies of any available
documentation such as written procedures, corrected labeling, etc.,
demonstrating that corrections have been made. If corrections cannot be
completed within 15 working days, state the reason for the delay and the date by
which the corrections will be completed.
Your reply should be directed to Paul A. Boehmer, Compliance Officer, at
the above address.
Sincerely,
/s/
Scott J. MacIntire District Director
Public Health Service Food and Drug Administration
Chicago District 550 West Jackson Blvd., 15th Floor Chicago, Illinois 60661
Telephone: 312-353-5863
June 15, 2004
WARNING LETTER
CERTIFIED MAIL RETURN RECEIPT REQUESTED
Mr. David W. Bernauer CEO and Chairman of the Board Walgreen co. 200 Wilmot
Rd. Deerfield, IL 60015
Dear Mr. Bernauer:
Inspection of your firm s warehouse at 5100 Lake Terrace N.E., Mt. Vernon,
Illinois, by the Illinois Department of Public Health and the U.S. Food and Drug
Administration (FDA) on February 25, 26, and 27, and March 2, 2004, documented
numerous insanitary conditions which caused the food and drug products stored
there to become adulterated.
Our inspection showed that the food and drug products stored and held at
your facility violated the Federal Food, Drug, and Cosmetic Act (the Act),
rendering them adulterated. These adulterated fwd and drug products: a)
consisted in whole or in part of filthy substances, including rodent fecal
pellets, rodent hair, and insects, in violation of Section 402(a)(3) of the Act
[21 U.S.C. 342(a)(3)]; and/or b) had been held under insanitary conditions
whereby they have become contaminated with rodent filth, in violation of
Sections 402(a)(4) and 501(a)(2)(a) of the Act [21 U.S.C. 342(a)(4),
351(a)(2)(a)].
Evidence of rodent activity documented throughout the old and new warehouse
included dead mice in traps, excreta pellets, and gnawed paper material observed
in, on, and near food and drugs stored in the warehouse. Rodents gnaw holes were
observed into several packaged food products with rodent hairs at gnaw holes
into products. Many more fecal pellets were on food and drug packages and still
more were found near the stored foods, drugs, and cosmetics in the warehouse.
Other conditions observed during the inspection that could be contributing
factors to rodent infestation include damaged and/or poorly fitting rail and
truck dock doors, gaps around a conduit entry into the building, and the
structural condition of the concrete and expansion gaps at floor/wall/support
beam junctions in various areas of the warehouse allowing the entry or harborage
of pests. Additionally, the investigators observed cobwebs, dead insects, dust,
debris, product spillage, and papers in the warehouse, indicating a general lack
of good sanitation practices.
Also, products that contain or may contain animal protein prohibited
ruminant feed (BSE material) failed to bear the caution statement, Do not feed
to cattle or other ruminants. Specifically, pet food products were salvaged,
repackaged, and donated to [redacted] and other similar organizations in the
area, without the proper labeling and agreement that they would not be used for
ruminants. Please refer to Title 21, Code of Federal Regulations, Section
589.2000, concerning these requirements.
Our laboratory confirmed the findings of rodent excreta, rodent hairs on
product gnaw holes, and rodent gnawed fibers (packaging material) sampled from
the warehouse during the inspection.
The above listed violations are not intended to be all-inclusive. It is
your responsibility to assure adherence with each requirement of the Act and its
implementing regulations. The investigators reported that you destroyed food
products that showed evidence of contamination and began to take some steps to
correct the insanitary conditions in your facility. We request that you take
prompt action to correct all violations.
Please provide this office, within 15 working days of receipt of this
letter, a detailed response stating the actions you plan to take and have taken
to correct and prevent the recurrence of these objectionable conditions. Provide
the time within which corrections will be completed, reasons why any corrective
action cannot be completed, and documentation to show that corrections have been
made. Failure to take prompt action to correct all violations may result in
regulatory action without further notice. Such action includes seizure and/or
injunction.
Your reply should be directed to Paul A. Boehmer, Compliance Officer, at
the Chicago District Office.
Sincerely,
/s/
Scott J. MacIntire District Director
cc: Stephen J. Lawrence, Distribution Center Manager Walgreen Co. 5100 Lake
Terrace NE Mount Vernon, IL 62864-9665
USA BSE GBR SHOULD BE GBR III, but someone dropped the ball...
TSS
######### http://mailhost-alt.rz.uni-karlsruhe.de/warc/bse-l.html
##########
-------- Original Message --------
Subject: MAD COW WARNING LETTER 700 lbs. Steer feed and 1,500 lb. Pig sow
fed Products may contain MAMMALIAN TISSUES USA
Date: Mon, 18 Oct 2004 11:32:17 –0500
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@UNI-KARLSRUHE.DE
##################### Bovine Spongiform Encephalopathy
#####################
PRODUCT
a) Product is 9 Mile Steer Feed, packaged in white poly weaved bags, each
containing 100 lbs. A white label tied to the inlet of each bag with twine
identifies the product. Recall # V-187-4;
b) Product is 9 Mile Pig and Sow Feed, packaged in white poly weaved bags,
each bag containing 100 lbs. A white label tied to the inlet of each bag with
twine identifies the product. Recall # V-188-4.
CODE
The products contain no code date.
RECALLING FIRM/MANUFACTURER
Farmers Elevator, Co., Houston, OH, by telephone and letters dated
September 8, 2004. Firm initiated recall is ongoing.
REASON
Products may contain protein derived from mammalian tissues which is
prohibited in ruminant (steer) feed. FDA regulation, if the feed is intended for
non-ruminants (pigs), the bag labels must bear the statement ìDo not feed to
cattle or other ruminantsî.
VOLUME OF PRODUCT IN COMMERCE
700 lbs. Steer feed and 1,500 lb. Pig and sow fed.
DISTRIBUTION
OH.
################# BSE-L-subscribe-request@uni-karlsruhe.de
#################
-------- Original Message --------
Subject: MAD DEER FEED BAN WARNING LETTER RECALL 6 TONS DISTRIBUTED USA
Date: Wed, 20 Oct 2004 14:53:56 –0500
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@UNI-KARLSRUHE.DE
##################### Bovine Spongiform Encephalopathy
#####################
PRODUCT
Product is custom made deer feed packaged in 100 lb. poly bags. The product
has no labeling. Recall # V-003-5.
CODE
The product has no lot code. All custom made feed purchased between June
24, 2004 and September 8, 2004.
RECALLING FIRM/MANUFACTURER
Farmers Elevator Co, Houston, OH, by telephone and letter dated September
27, 2004. Firm initiated recall is ongoing.
REASON
Feed may contain protein derived from mammalian tissues which is prohibited
in ruminant feed.
VOLUME OF PRODUCT IN COMMERCE
Approximately 6 tons.
DISTRIBUTION
OH.
END OF ENFORCEMENT REPORT FOR October 20, 2004
################# BSE-L-subscribe-request@uni-karlsruhe.de
#################
Public Health Service Food and Drug Administration
Seattle District Pacific Region 22201 23rd Drive SE Bothell, WA 9S9214421
Telephone: 425-486-8788 FAX: 425- 483-4996
November 18, 2004
VIA FEDEX
In reply refer to Warning Letter SEA 05-07
William B. Parrish, Chairman of the Board Parrish & Heimbecker Limited
360 Main Street Winnipeg, Manitoba, R3C 323 Canada
WARNING LETTER
Dear Mr. Parrish:
An inspection of your feed mill operation, Conway Feed, Inc., located at
18700 Main Street, Conway, Washington, conducted by a Washington State
Department of Agriculture Investigator, on June 17, 18 and 22, 2004, under
contract with the Food and Drug Administration (FDA), found significant
deviations from the requirements set forth in Title 21, Code of Fedederal
Regulations, Part 589.2000 (21 CFR 589.2000) Animal Proteins Prohibited in
Ruminant Feed. The regulation is intended to prevent the establishment and
amplification of Bovine Spongiform Encephalopathy (BSE). Such deviations cause
products being manufactured and/or distributed by this facility to be
adulterated within the meaning of Section 402(a)(4) and misbranded within the
meaning of Section 403(a) and 403(f) of the Federal Food, Drug and Cosmetic Act
(the Act).
Our investigation found that because you failed to adequately inspect the
label of a raw material, au ingredient with the cautionary statement Do Not Feed
to Cattle or Other Ruminants was used in the manufacture of your finished
product, Game Bird Crum/Pellet. Your final product, however, did not have the
cautionary statement. Because this fish meal may have contained prohibited
animal proteins, any product produced with it must have the cautionary label.
See 21 CFR 589.2000(d)(1).
The investigation also revealed that the label of your Game Bird
Crum/Pellet feed did not list fish meal as an ingredient. According to the
information we collected during the inspection fish meal is routinely added to
this ration. All ingredients are required to be listed on the label in
descending order of predominance by weight. See 21 CFR 501.4(a).
The above is not intended to be an all-inclusive list of deviations from
the regulations. As a manufacturer of materials intended for animal feed use,
you are responsible for assuring that your overall operation and the products
you manufacture and distribute are in compliance with the law. We have enclosed
a copy of the FDA s Small Entity Compliance Guide to assist you with complying
with the regulation.
You should take prompt action to correct these violations, and you should
establish a system whereby such violations do not recur. Failure to promptly
correct these violations may result in regulatory action without further notice,
such as seizure and/or injunction.
You should notify this office in writing within 15 working days of receipt
of this letter, of the steps you have taken to bring your firm into compliance
with the Iaw. Your response should include an explanation of each step being
taken to correct the violations, and prevent their recurrence. If corrective
action cannot be completed in 15 working days, state the reason for the delay
and the date by which the corrections will be completed. Include copies of any
available documentation demonstrating that corrections have been made.
Please send your reply to the Food and Drug Administration, Attention:
Bruce Williamson, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington
98021. If you have questions regarding any issue in this letter, please contact
Mr. Bruce Williamson at (425) 483-4976.
If you have questions regarding any issue in this letter, please contact
Mr. Bruce Williamson at (425) 483-4976.
Sincerely,
/S/
Charles M. Breen District Director
cc: Scott C. McKnight, General Manager Conway Feed Inc. 18700 Main Street
Conway, WA 98238-0576
Enclosure: Form FDA 483 Small Entity Compliance Guide
-------- Original Message --------
Subject: MAD COW FEED BAN WARNING LETTER Animal Proteins Prohibited in
Ruminant Feed/Misbranded DEC. 9, 2004
Date: Tue, 21 Dec 2004 16:04:44 –0600
From: "Terry S. Singeltary Sr."
To: Bovine Spongiform Encephalopathy
CC: cjdvoice@yahoogroups.com
Public Health Service Food and Drug Administration
New Orleans District Southeast Region 6600 Plaza Drive, Suite 400 New
Orleans, Louisiana 70127 Telephone: 504-253-4519 Facsimile: 504-253-4520
December 9, 2004
WARNING LETTER NO. 2005-NOL-07
FEDERAL EXPRESS OVERNIGHT DELIVERY
Mr. Alan O. Bostick, President Sunshine Mills, Inc. 500 6th Street SW Red
Bay, Alabama 35582
Dear Mr. Bostick:
On September 7 and 14, 2004, a United States Food and Drug Administration
(FDA) investigator inspected your animal feed manufacturing facility, located at
2103 South Gloster Street, Tupelo, Mississippi. The inspection revealed
significant deviations from the requirements set forth in Title 21, Code of
Federal Regulations, Part 589.2000 (21 CFR 589.2000) - Animal Proteins
Prohibited in Ruminant Feed. The regulation is intended to prevent the
establishment and amplification of Bovine Spongiform Encephalopathy (BSE).
Because you failed to follow the requirements of this regulation, products you
manufactured and/or distributed are misbranded within the meaning of Section
403(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).
The inspection indicated you manufacture products containing beef meat and
bone meal. Products that contain or may contain protein derived from mammalian
tissues, as defined by 21 CFR 589.2000(a), and are intended for use in animal
feed, must be labeled with the cautionary statement Do not feed to cattle or
other ruminants. This is required by 21 CFR 589.2000(c)(1)(i). Your firm failed
to label your non-ruminant products with this required cautionary statement.
Specifically, the products that contained protein derived from mammalian tissues
but lacked the required statement included your Happy Fisherman and Premier
catfish feeds. Under 21 CFR 589.2000(g)(2), failure of these feeds to bear the
required cautionary statement causes them to be misbranded under Section
403(a)(1) of the Act.
The above is not intended to be an all-inclusive list of deviations from
regulations. As a manufacturer of materials intended for animal feed use, you
are responsible for assuring your overall operation and products you manufacture
and distribute are in compliance with the law. A copy of FDA s Small Entity
Compliance Guide is enclosed to assist you in complying with the regulations.
You should take prompt action to correct these violations and establish a
system whereby such violations do not recur. Failure to promptly correct these
violations may result in regulatory action, such as seizure and/or injunction,
without further notice.
We are aware you sent label corrections for the last shipment of each of
the mislabeled products. You also stated you plan [redacted] However, you should
notify this office in writing, within 15 working days of the receipt of this
letter, of the steps you have taken to bring your firm into compliance with the
law. Your response should include an explanation of each step taken to correct
violations and prevent their recurrence. If corrective action cannot be
completed within 15 working days, state the reason for delay and date by which
corrections will be completed. Include copies of any available documentation
demonstrating corrections have been made.
Please send your reply to the U.S. Food and Drug Administration, Attention:
Nicole F. Hardin, Compliance Officer, at the above address. If you have
questions regarding any issue in this letter, please contact Ms. Hardin at (504)
253-4519.
Sincerely,
/s
H. Tyler Thornburg District Director New Orleans District
Enclosures: FDA Form 483 FDA s Small Entity Compliance Guide 21 CFR
589.2000
cc: [redacted] General Manager Sunshine Mills, Inc. 2103 South Gloster
Street Tupelo, Mississippi 38801
TSS
2003
-------- Original Message --------
Subject: MAD COW FEED BAN WARNING LETTER Animal Proteins Prohibited in
Ruminant Feed/Misbranded
Date: Tue, 23 Sep 2003 15:46:19 –0500
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de
Public Health Service Food and Drug Administration
DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration
Chicago DiStriCt 550 West Jackson Blvd., 15th Floor
August 25,2003
Chicago, Illinois 60661
Telephone: 312-353-5863 WARNING LETTER CH-19-03 CERTIFIED MAIL RETURN
RECEIPT REQUESTED
William H. Jenner, President Lincoln Land Livestock Co., Inc. 436 South
Railway Ave. Maswutah, Illinois 62258
Dear Mr. Jenner: On April 14 and 15,2003, the Food and Drug Administration
(FDA) conducted an inspection at your animal feed handling facility at 436 South
Railway Ave., Mascoutah, Illinois, that, among other things. operates as an own
label distributor of Hot Line brand feeds made for you by The inspection found
significant deviations from the requirements set forth in Title 21, Code of
Federal Regulations, Part 589.2000 (21 CFR 589.2000) - Animal Proteins
Prohibited in Ruminant Feed.
This regulation is intended to prevent the establishment and amplification
of Bovine Spongiform Encephalopathy (BSE). Such deviations cause products being
handled by your facility to be misbranded within the meaning of Section
403(a)(l) of the Federal Food, Drug, and Cosmetic Act (the Act). The inspection
also found significant deviations from the requirements set forth in 21 CFR 501
- Animal Food Labeling. Our investigator found the following violations during
the inspection: Products that contain or may contain prohibited material fail to
bear the caution statement - Do not feed to cattle or other ruminants as
required by 21 CFR 589.2OOO(c)( l)(i). Specifically, your firm is responsible
for preparing the formulations and labeling for Lincoln Land labeled products
and some of the products lack the above required cautionary statement. Product
ingredients are not listed on the label of the product Hotline Sow 100 by common
or usual name in descending order of predominance by weight as required by 21
CFR 501.4. Also, the ingredient list on the label does not reflect all the
ingredients.
Page 2 During the inspection FDA s investigator also found that you did not
maintain written clean-out procedures to prevent carryover of protein derived
fi-om mammalian tissues to animal protein or feeds that may be used for
ruminants. You had no written procedures that describe the steps used to clean
your truck after hauling bulk meat and bone meal. 21 CFR 589.2000 requires
maintenance of written clean-out procedures. The above is not intended to be an
all-inclusive list of violations. While you handle the animal feed label and
distribution operations, the products man are directed, through contract
arrangement with the above mentioned Your firm, as the handler and labeler of
materials intended for animal feed use, is responsible for controlling your part
of the operation to ensure that the products manufactured are in compliance with
the law. You should take prompt action to correct all of these violations, and
you should establish a system whereby such violations do not recur. Failure to
promptly correct these violations may result in regulatory action without
further notice, such as seizure, and/or injunction. Please provide this office
within 15 working days of receipt of this letter the steps you have taken to
bring your firm into compliance with the law. Your response should include an
explanation of each step taken to correct the violations, and prevent their
recurrence. Please include copies of any available documentation such as written
procedures, corrected labeling, etc. demonstrating that corrections have been
made. If corrections cannot be completed within 15 working days, state the
reason for the delay and the date by which the corrections will be completed.
Your reply should be directed to Paul A. Boehmer, Compliance Officer, at the
above letterhead address. Sincerely, \s\ Arlyn H. Baumgarten District Director
Subject: MAD COW FEED BAN WARNING LETTER (disguised as medicated feed
warning letter)
Date: Tue, 1 Apr 2003 08:39:26 –0600
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de
######## Bovine Spongiform Encephalopathy #########
Food and Drug Administration Cincinnati District Office Central Region 6751
Steger Drive Cincinnati, OH 45237-3097 Telephone: (513) 679-2700 FAX: (513)
679-2771
March 4, 2003
WARNING LETTER CIN-03-16534 FedEx
William E. Leininger, Director of Operations Buckeye Egg Farm L.P. 11212
Croton Road Croton, OH 43013
Dear Mr. Leininger:
An inspection of your medicated feed mill located at 10750 Croton Road,
Croton, OH 43013, conducted by Food and Drug Administration investigators, on
1/27, 30/2003, found significant deviations from Current Good Manufacturing
Practice (CGMP) regulations for Medicated Feeds (Title 21 CODE OF FEDERAL
REGULATIONS, Part 225). Such deviations cause feeds being manufactured at this
facility to be adulterated within the meaning of section 501(a)(2)(B) of the
Federal Food, Drug, and Cosmetic Act.
Our investigation found:
1. failure to conduct potency assays on at least three representative
samples of each feed required to be manufactured by a licensed feed mill at
periodic intervals during the calendar year [21 CFR 225.58(b)(1); 2. failure to
maintain a daily inventory record for each drug used [21 CFR 225.42(b)(7)]; 3.
failure to calibrate scales and metering devices at least once a year to insure
their accuracy [21 CFR 225,30(b)(4)]; 4. failure to properly identify drugs in
the mixing area to maintain their integrity and identity [21 CFR 225.42(b)(4);
5. failure to use all Type B medicated feed articles in accordance with labeled
mixing directions [21 CFR 225.142]; 6. failure to have a qualified person check,
date, and sign or initial each Master Record File [21 CFR 225.102(b)(l); 7.
failure to identify medicated feed with appropriate labeling which, if adhered
to, will assure the article is safe and effective for its intended purpose [21
CFR 225.80(a)].
In addition to the, deviations described above, our investigators found
that your products, which contain or may contain prohibited materials, fail to
bear the caution statement: "Do not feed to cattle or other ruminants", as
required by 21 CFR 589.2000(d). This causes your medicated feed to be misbranded
within the meaning of section 403(a)(1) of the Federal Food, Drug, and Cosmetic
Act.
Your firm has also failed to maintain a current Drug Establishment
Registration in that your registration expired in April 2001. This causes your
medicated feed to be misbranded within the meaning of section 502(o) of the
Federal Food, Drug, and Cosmetic Act.
The above is not intended as an all-inclusive list of CGMP violations. As a
manufacturer of medicated and non-medicated feeds, you are responsible for
assuring that your overall operation and the products you manufacture and
distribute are in compliance with the law.
You should take prompt action to correct these CGMP violations, and you
should establish procedures whereby such violations do not recur. Failure to
promptly correct these CGMP violations may result in regulatory and/or
administrative sanctions. These sanctions include, but are not limited to,
seizure, injunction, and/or notice of opportunity for a hearing on a proposal to
withdraw approval of your Medicated Feed Mill License under section
512(m)(4)(B)(ii) of the Act and 21 CFR 515.22(c)(2). This letter constitutes
official notice under the law of CGMP violations. Based on the results of the
01/27, 30/2003 inspection, the methods used in, or the facilities and controls
used for, the manufacture, processing, and packing of medicated feeds are
inadequate to assure and preserve the identity, strength, quality, and purity of
the new animal drugs therein. This letter notifies you of our findings and
provides you an opportunity to correct the above deficiencies.
You should notify this office, in writing, within fifteen (15) working days
of the receipt of this letter of the steps you have taken to bring your firm
into compliance with the law. Your response should include an explanation of
each step being taken to correct the CGMP violations and prevent their
recurrence. If corrective action cannot be completed within 30 working days,
state the reason for the delay and the date by which the corrections will be
completed. Include copies of any available documentation demonstrating that
corrections have been made.
Your response should be directed to Charles S. Price Compliance Officer,
U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237-3097.
If you have any questions regarding this letter, you may call Mr. Price at
telephone (513) 679-2700 extension 165.
Sincerely,
/s/
Carol A. Heppe,
District Director
Cincinnati District
>In addition to the, deviations described above, our investigators found
that your products, which contain or may contain prohibited materials, fail to
bear the caution statement: "Do not feed to cattle or other ruminants", as
required by 21 CFR 589.2000(d). This causes your medicated feed to be misbranded
within the meaning of section 403(a)(1) of the Federal Food, Drug, and Cosmetic
Act.<
Greetings list members,
it would seem to me this should have been a separate warning letter on the
issues of 21 CFR 589.2000(d) and not hidden and imbedded in a warning letter
with the title;
Lacks Ruminant Caution/Medicated Feeds/Adulterated/Misbranded
opposed to past titles;
Animal Proteins Prohibited in Ruminant Feed/Adulterated
nice try;-)
TSS
########### http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html
############
-------- Original Message --------
Subject: 517,990 LBS. OF RUMINANT PROTEIN IN CATTLE FEED DISTRIBUTED AND
MORE ...
Date: Tue, 29 Apr 2003 11:21:52 -0500 From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy To: BSE-L@uni-karlsruhe.de
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II
______________________________
PRODUCT Unlabeled bulk "Cattle Feed" sold by weight to user/farmers who
pick it up at the firm. Product is a ruminant feed used to feed beef cattle.
Recall # V-046-3. CODE Product is bulk and uncoded. RECALLING FIRM/MANUFACTURER
Zephyr Feed Company, Zephyrhills, FL., by letters on March 19, 2003 and March
26, 2003. FDA initiated recall is ongoing.
REASON Cattle feed was distributed to farmers that may contain prohibited
protein for ruminants.
VOLUME OF PRODUCT IN COMMERCE 517,990 lbs. DISTRIBUTION FL.
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE--CLASS II
_____________________________
PRODUCT Red Rooster Booster, Super Gallo (brand), 60 capsules. Recall #
V-011-3. CODE All codes. RECALLING FIRM/MANUFACTURER Thomas Laboratories,
Tolleson, AZ, by letters on or about November 8, 2002. State initiated recall is
ongoing.
REASON Is not labeled "Do not feed to cattle or other ruminants" and
contains a bovine tissue derivative.
VOLUME OF PRODUCT IN COMMERCE Unknown.
DISTRIBUTION Nationwide.
_____________________________
PRODUCT CATTLE FEED, Flock #999, Date: 12/5/02, Quantity 8000, Load A, Feed
C205, Grower# Z001, Tag C100. Recall # V-012-3. CODE C-205, C-210, C-220, C-302,
C-406 and all other codes manufactured and distributed by Grove River Mills,
Inc., RECALLING FIRM/MANUFACTURER Grove River Mills Inc., Pendergrass, GA, by
telephone and letter on December 9, 2002. Firm initiated recall is ongoing.
REASON Cattle Feed contaminated with prohibited materials.
VOLUME OF PRODUCT IN COMMERCE 235,668 lbs. DISTRIBUTION GA.
END OF ENFORCEMENT REPORT FOR FEBRUARY 5, 2003
another description here;
FEBRUARY 2003
PRODUCT Red Rooster Booster, Super Gallo (brand), 60 capsules.
CODE All codes. RECALLING FIRM/MANUFACTURER Thomas Laboratories, Tolleson,
AZ,
REASON Is not labeled "Do not feed to cattle or other ruminants" and
contains a bovine tissue derivative. VOLUME OF PRODUCT IN COMMERCE Unknown.
DISTRIBUTION Nationwide.
PRODUCT CATTLE FEED, Flock #999, Date: 12/5/02, Quantity 8000, Load A, Feed
C205, Grower# Z001, Tag C100.
CODE C-205, C-210, C-220, C-302, C-406 and all other codes manufactured and
distributed by Grove River Mills, Inc., RECALLING FIRM/MANUFACTURER Grove River
Mills Inc., Pendergrass, GA,
REASON Cattle Feed contaminated with prohibited materials.
VOLUME OF PRODUCT IN COMMERCE 235,668 lbs. DISTRIBUTION GA.
Red Rooster Booster - 60 Capsules $7.95 210-4610-C03
Concentrated nutritional supplement for body building gamebirds.
interesting; Bone Meal with D3 - 25 lb. Powder $69.95 520-0210-P09
hell, no wonder humans are becoming resistant to antibiotics;
Fish Cillin (Ampicillin) 250mg - 30 Capsules
$11.95 00-10136-C01 Thomas Labs
Fish Cillin (Ampicillin) 250mg - 100 Capsules
$29.95 00-10136-C03 Thomas Labs
Fish Cycline (Tetracycline) 250mg - 30 Capsules
$7.95 00-10132-C01 Thomas Labs
Fish Cycline (Tetracycline) 250mg - 100 Capsules
$15.95 00-10132-C03 Thomas Labs
Fish Flex (Cephalexin) 250mg - 30 Capsules
$15.95 00-12136-C01 Thomas Labs
Fish Flex (Cephalexin) 250mg - 60 Capsules
$29.95 00-12138-C02 Thomas Labs
Fish Flex (Cephalexin) 250mg - 100 Capsules
$39.95 00-12138-C03 Thomas Labs
Fish Fungus (Ketoconazole) 200 mg - 30 Tablets
$39.95 00-0024-T01 Thomas Labs
Fish Mox (Amoxicillin) 250mg - 30 Capsules
$7.95 00-10131-C01 Thomas Labs
Fish Mox (Amoxicillin) 250mg - 100 Capsules
$15.95 00-10131-C03 Thomas Labs
Fish Mycin (Erythromycin) 250mg - 30 Tablets
$15.95 00-10902-T01 Thomas Labs
Fish Mycin (Erythromycin) 250mg - 100 Tablets
$29.95 00-10902-T03 Thomas Labs
Terramycin TM-20 - 8 oz. Powder
wonder if these mycin's are any relative of the VANCOMYCIN ???
http://www.thomasveterinarydrug.com/mailorder/catalog/default.php?manufacturers_id=11&sort=1a&page=4
TSS
-------- Original Message --------
Subject: Re: MAD COW FEED BAN WARNING LETTER USA (a real hum dinger) !
Date: Tue, 24 Jun 2003 16:59:41 -0500
From: "Terry S. Singeltary Sr."
To: Bovine Spongiform Encephalopathy
References: 3EE5D269.9040504@wt.net
i hate to keep kicking a mad cow here, but i thought since the FDA et al
still refuses to tell us about _all_ the ruminant-to-ruminant feed ban
violations, i thought i would go over a few of the old ones i might have missed.
BOY, did i miss one. has all this feed been confirmed to have been recalled? how
much is still out there?
RECALLS AND FIELD CORRECTIONS: VETMED -- CLASS II
________
PRODUCT & CODES:
Animal feed products, packaged in 5, 25, 50, and 55 pound bags, and in
bulk,
intended for both ruminant and non-ruminant animals. The products are as
follows:
Recall # V-195-1 through V-350-1.
RUMINANT FEED PRODUCTS:
RECALL NO. PRODUCT NO. PRODUCT NAME
V-195-1 40150 B. 30% Calf Pellet
V-196-1 40250 B. 16% Calf Pellet
V-197-1 40350 B. 16% Calf Ration
V-198-1 40450 B. 18% Calf Starter
V-199-1 40600 B. 38% Dairy Pellet
V-200-1 40650 B. 38% Dairy Pellet
V-201-1 40750 B. 16% Dairy Feed
V-202-1 40950 B. 40% Beef Pellet
V-203-1 41150 B. 18% Lamb Starter Pellet
V-204-1 41250 B. 39% Lamb Conc. Pellet
V-205-1 41350 B. 14% Lamb & Beef Pellet
V-206-1 41450 B. 16% Goat Feed
V-207-1 42150 B. 32% Expectation Pellet
V-208-1 42250 B. Llama & Alpaca Pellet
V-209-1 42350 B. 32% Calf Grower Pellet
V-210-1 42650 B. Llama & Alpaca Crums
V-211-1 42750 B. 38% Hay Booster 2
V-212-1 42850 B. 25% Pasture Booster
V-213-1 43100 B. 16% Grower/Dev Pellet
V-214-1 43150 B. 16% Grower/Dev Pellet
V-215-1 43700 WH 32% Calf Gro Pellet
V-216-1 43750 WH 32% Calf Gro Pellet
V-217-1 43850 B. 38% Dairy Mix
V-218-1 44250 B. 17% Doe Pellet
V-219-1 44350 B. 21% Buck Pellet
V-220-1 44450 Legends Ranch Pellet
V-221-1 44500 Legends 17% Breeder Pellet
V-222-1 1652 B. Vitamin E-20
V-223-1 1614 B. Vitamin A-30
V-224-1 44550 Legends 17% Breeder Pellet
V-225-1 44650 Legends 13.5% Rut Pellet
V-226-1 44750 Deer Starter (J)
V-227-1 44940 Llama Premix (J) FSC
V-228-1 45150 Empire 25% Calf Pellet
V-229-1 45450 Berry Llama Pellet
V-230-1 45950 50% Beef Conc. (Meal)
V-231-1 46250 B. 12% Sweet Livestock
V-232-1 46350 B. 1440 Bovatec Pellet
V-233-1 46400 Liberty 38% Dairy Pellet
V-234-1 46450 Liberty 38% Dairy Pellet
V-235-1 47150 B. 14% Gold-n-Grower
V-236-1 47250 B. 12% Gold-n-Conditioner
V-237-1 47450 B. 18% Gold-n-Lamb
V-238-1 47800 Homeworth Dairy Pellet
V-239-1 47850 Homeworth Dairy Pellet
V-240-1 47900 B. 36% Hi Fat Dairy Pellet
V-241-1 47950 B. 36% Hi Fat Dairy Pellet
V-242-1 48550 B. 16% Calf Pellet CA
V-243-1 49200 Mastead Dairy Base
V-244-1 49300 KLEJKA Dairy Base
V-245-1 49650 Deer Premix (J) HFB
V-246-1 49750 39% Lamb Premix (J) HFB
V-247-1 49850 Lamb Starter Premix (J) HFB
V-248-1 120850 Brood Cow Deluxe Mineral
V-249-1 152850 B. A-D-E Mix
NON-RUMINANT FEED PRODUCTS:
V-250-1 10150 B. Miracle Starter
V-251-1 10350 B. 21% Broiler Starter
V-252-1 10450 B. Pullet Grower & Developer
V-253-1 10550 B. 18% Layer Breeder Pellets
V-254-1 10750 B. 20% Gold Std. Laying Crum
V-255-1 10950 B. 17% Complete Laying Crums
V-256-1 11050 B. 16% Prosperity Layer Crums
V-257-1 11100 B. 40% Poultry Concentrate
V-258-1 11150 B. 40% Poultry Concentrate
V-259-1 11250 B. 28% Turkey Starter Crums
V-260-1 11350 20% Gig "4" Pellets
V-261-1 11450 B. 16% Prosperity Layer Pellets
V-262-1 11550 18% Game Bird Breeder Pellets
V-263-1 11650 B. 19% Ratite Grower Diet
V-264-1 11750 B. 23% Ratite Breeder Diet
V-265-1 12100 B. 40% Poultry Concentrate Crums
V-266-1 12550 B. 32% Base Poultry Mix
V-267-1 13250 B. 28% Turkey Starter
V-268-1 13450 B. 20% Poultry Grower
V-269-1 14325 B. Game Bird Mix - Coarse
V-270-1 20150 B. 18% Pig Starter Pellets
V-271-1 20250 B. 16% Pig Grower Pellets
V-272-1 20450 B. 14% Porkmaker 100 Pellets
V-273-1 20550 B. 40% Gro 'Em Lean
V-274-1 21850 B. 27% Hi-Fat Swine Base
V-275-1 23000 Mt. Hope Hevy Hog
V-276-1 30050 12% Pleasure Horse - Sweet
V-277-1 30150 Alfa + Performer 10 Sweet
V-278-1 30250 14% Grass + Perf Sweet
V-279-1 30450 12% Wrangler - Complete
V-280-1 30550 B. 12% Pleasure Horse Pellets
V-281-1 30650 B. 32% Gro' N Win Pellets
V-282-1 30750 12% Wrangler Cubes
V-283-1 30950 18% Foal Starter
V-284-1 31050 B. 14% Alfa + Dev Pellets
V-285-1 31150 B. Alfa + Performer 10 Pel
V-286-1 31200 Grass +Performer 14 Pel
V-287-1 31250 Grass +Performer 14 Pel
V-288-1 31350 12% Mustang
V-289-1 31450 Endurance - 101 Extruded
V-290-1 31550 B. Equine Energy - UK
V-291-1 31650 B. 16% Grass + Dev Pellets
V-292-1 31750 16% Grass + Dev Cubes
V-293-1 31850 16% Grass + Dev Sweet
V-294-1 31950 B. 11% Alfa Gro 'N Win Pel
V-295-1 32050 B. Sho' Win Pellets
V-296-1 32250 B. Senior Formula
V-297-1 32350 Oscar Horse Mix
V-298-1 32450 B. Ultimate Finish
V-299-1 32550 Crossfire Horse Feed
V-300-1 32650 B. Equine 16% Growth
V-301-1 32750 B. Reduced Energy Formula
V-302-1 32850 B. Training Formula
V-303-1 32950 B. Cadence Formula
V-304-1 33150 B. Track 12 Horse Feed
V-305-1 33350 Spears 16% GR + Dev Cubes
V-306-1 33400 B. 14% Supreme Horse Pellets
V-307-1 33450 B. 14% Supreme Horse Pellets
V-308-1 33650 B. Race'N Win
V-309-1 33750 B. 14% Prominent Horse Feed
V-310-1 33850 B. Unbeetable Horse Feed
V-311-1 34750 Cargill Senior Horse
V-312-1 34850 Cargill Vitality Gold
V-313-1 35150 Chagrin 12% Sweet Fd
V-314-1 35250 Smith Pure Pleasure
V-315-1 35750 Roundup 10% Horse Pellets
V-316-1 35850 12% Summerglo Horse
V-317-1 36255 B. Grass +Min&VitBase - Mexico
V-318-1 36850 Miller's 12% Horse Feed
V-319-1 37155 B. Gro'Win Base Mix - Mexico
V-320-1 38000 B. 32% Premium Mixer Pellets
V-321-1 38050 B. 32% Premium Mixer Pellets
V-322-1 38100 36% Maintenance Mixer Pellets
V-323-1 38150 36% Maintenance Mixer Pellets
V-324-1 50150 Terramycin Crumbles
V-325-1 60105 16% Rabbit Pellets
V-326-1 60125 16% Rabbit Pellets
V-327-1 60150 B. 16% Rabbit Pellets
V-328-1 60205 18% Rabbit Developer
V-329-1 60250 B. 18% Rabbit Developer
V-330-1 60450 B. 16% Rabbit Maintenance
V-331-1 90150 B. Buckeye Scratch
V-332-1 90225 Gold Standard Scratch
V-333-1 90250 Gold Standard Scratch
V-334-1 90350 Intermediate Scratch
V-335-1 90450 B. Chick Grains
V-336-1 90525 B. Shelled Corn
V-337-1 90550 B. Shelled Corn
V-338-1 90650 B. Cracked Corn
V-339-1 90825 B. Fine Cracked Corn
V-340-1 90850 B. Fine Cracked Corn
V-341-1 91000 Steam Flaked Corn
V-342-1 91050 Steam Flaked Corn
V-343-1 91750 Oats - HP Crimped
V-344-1 91850 B. HP Sweet Crimped Oats
V-345-1 95550 Land O' Lakes Shelled Corn
V-346-1 95650 Land O' Cracked Corn
V-347-1 95850 Land O' Lakes Chick Crack
V-348-1 100850 B. Alfalfa Pellets
V-349-1 101850 Cooked Full Fat Soybean
V-350-1 122200 Magnatone M-4-B Pels Bulk
MANUFACTURER:
Buckeye Feed Mills, Dalton, Ohio.
RECALLED BY:
Manufacturer visited local customers on April 17, 2001. On April 18 and 19,
2001, manufacturer mailed and faxed recall notices. Firm initiated recall is
ongoing.
DISTRIBUTION:
Al, CT, DE, FL, GA, IL, IN, IA, KY, ME, MD, MA, MO, MN, MS, NH, NJ, NY, NC,
OH, OR, PA, RI, TN, VA, WV, and WI.
QUANTITY:
2,790 tons of ruminant feed products and 14,000 tons of non-ruminant feed
products.
REASON:
The animal feed products may contain protein derived from mammalian
tissues.
snip...
END OF ENFORCEMENT REPORT FOR June 6, 2001.
wish someone would give us that update they were speaking of a year or so
ago;
Database Change
IMPORTANT: After March 11, 2002, FDA discontinued the database that was
used to compile these listings. The Agency started a new database on April 15,
2002, and future updates on BSE enforcement and inspectional findings will draw
from it. The format of the information presented here may change, due to design
changes of the new database. The site was to be updated after a period of time
to allow for transition into the new database system. Please note that the
information presently available below is outdated. This site will be updated
very shortly.
i guess figuring the time period on the reply from the FOIA request of
being about a year or so, and still no results, why should this surprise me?
USA/CANADA/MEXICO BSE GBR SHOULD BE CHANGED TO BSE GBR III ASAP!
Subject: Re: MAD COW FEED BAN WARNING LETTER USA (FLOATING CATFISH FOOD
MAY 2003) !
Date: June 24, 2003 at 8:03 pm PST
In Reply to: Re: MAD COW FEED BAN WARNING LETTER USA (a real hum dinger) !
posted by TSS on June 24, 2003 at 3:07 pm:
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
______________________________
PRODUCT
Consolidated Nutrition 32 % Floating Catfish Food, packaged in 50-lb bags.
Recall # V-100-3.
CODE
Best By MAR 25 04; and Best By APR 16 04, The codes are ink-jetted on the
bags.
RECALLING FIRM/MANUFACTURER
Doane Pet Care Company, Inc., Washington Courthouse, OH, by telephone and
letter on April 16, 2003 and April 17, 2003. FDA initiated recall is ongoing.
REASON
The fish feed product lacks the required BSE warning statement, and the
nutritional ingredient statement on the label.
VOLUME OF PRODUCT IN COMMERCE
210/50 lb bags.
DISTRIBUTION
OH, PA, and MI.
END OF ENFORCEMENT REPORT FOR MAY 21, 2003
-------- Original Message --------
Subject: MAD COW FEED BAN WARNING LETTER USA (a real hum dinger) !
Date: Tue, 10 Jun 2003 07:43:21 –0500
From: "Terry S. Singeltary Sr."
To: BSE-L@UNI-KARLSRUHE.DE
CC: CJDvoice , bloodcjd@yahoogroups.com
Public Health Service Food and Drug Administration
New Orleano District Nashville Branch Office Plus Park Blvd. Nashville, TN
37217 Tel: 615-781-6388 FAX: 615-781-6383
May 22, 2003
VIA FEDERAL EXPRESS OVERNIGHT DELIVERY
Mr. John F. Turner, Owner, Manager Millstone Agri Distributors 3721 E.
Lamar Alexander Highway Maryville, TN 37804
Warning Letter No 03-NSV-16
Dear Mr. Turner:
An inspection of your animal feed manufacturing operation, located at
Maryville, Tennessee conducted by a U.S. Food and Drug Administration
investigator on February 13, 2003, found significant deviations from the
requirements set forth in Title 21, Code of Federal Regulations (21 CFR.), Part
589.2000 - Animal Proteins Prohibited in Ruminant Feed. The regulation is
intended to prevent the establishment and amplification of Bovine Spongiform
Encephalopathy (BSE). Because you failed to follow this rule, products you
manufactured and distributed are adulterated within the meaning of Sections
402(a)(2)(C) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act)
since they contain an unsafe food additive and were prepared, packed, or held
under insanitary conditions . . . whereby [they] may have been rendered
injurious to health. Feed you manuf~tured also was misbranded within the meaning
of Section 403(a)(1) of the Act because of your failure to follow this rule.
Our investigation found the following violations of 21 C.F.R. 589.2000:
1. Failure to separate the receipt, processing, and storage of products
containing prohibited material from products not containing prohibited material
[21 C.F.R. 589.2000(e)(1)(iv)];
2. Failure to establish written procedures, including clean-out and
flushing procedures, to avoid commingling and cross-contamination of common
equipment [21 C.F.R. 589.2000(e)(1)(iii)(B)];
3. Failure to maintain records sufficient to track prohibited materials
throughout the receipt, processing, and distribution of your products [21 C.F.R.
589.2000(c)(1)(ii)];
4. Failure to provide for measures to avoid commingling or
cross-contamination of feeds intended for ruminants and feeds intended for
nonruminants that may contain prohibited materials [21 C.F.R.
589.2000(c)(1)(iii)]. Specifically, our investigation found that the ruminant
product 10% Beef Conditioned was formulated primarily with screenings and fines
derived from previously manufactured non-ruminant products, Premium Rooster
Kicker in particular, that contain or may contain prohibited material. Such
deviations cause the ruminant product 10% Beef Conditioner being manufactured at
this facility to be adulterated within the meaning of Sections 402(a)(2)(C) and
402(a)(4) of the Act;
5. Failure to label your non-ruminant products with the required cautionary
statement Do not Feed to Cattle or Other Ruminants [21 C.F.R.
589.2000(c)(1)(ii)]. Our investigation specifically found that dog food
containing prohibited material was added as an ingredient to your product
Premium Rooster Kicker. The failure of these feeds to bear the required BSE
warning statement causes them to be misbranded within the meaning of Section
403(f) of the Act.
The above is not intended to be an all-inclusive list of deviations from
the regulations. As a manufacturer of materials intended for animal feed use,
you are responsible for assuring that your overall operation and the products
you manufacture and distribute are in compliance with the law. We have enclosed
a copy of the FDA s Small Entity Compliance Guide to assist you with complying
with the regulations.
You should take prompt action to correct these violations, and you should
establish a system whereby such violations do not recur. Failure to promptly
correct these violations may result in regulatory action without further notice,
such as seizure and/or injunction. You should notify this office in writing
within 15 working days of receipt of this letter of the steps you have taken to
bring your iirm into compliance with the law. Your response should include an
explanation of each step being taken to correct the violations, and prevent
their recurrence. If corrective action cannot be completed in 15 working days,
state the reason for the delay and the date by which the corrections will be
completed. Include copies of any available documentation demonstrating that
corrections have been made.
Your reply should be directed to the attention of Joseph E. Hayes,
Compliance Officer, U.S. Food and Drug Administration, 297 Plus Park Boulevard,
Nashville, TN 37217.
Sincerely,
/s/ Carl E. Draper Director, New Orleans District Office
Subject: Re: USA ruminant-to-ruminant feed ban warning letters ??? (All the
President's yes-men?)
Date: Wed, 29 Jan 2003 15:32:22 –0600
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de References: <3e21c7b9 .8040309=".8040309" wt.net="wt.net">
######## Bovine Spongiform Encephalopathy #########
Nature 421, 459 (2003); doi:10.1038/421459a
All the President's yes-men?
George W. Bush's administration stands accused of biasing the process by
which the US government obtains scientific advice. There is a strong case to
answer, but the situation is not as unusual as it might at first seem.
The relationship between science and politics is never perfect, but critics
charge that the current US administration has so politicized the provision of
scientific advice that it could permanently undermine public trust.
Just last week, a storm of protest greeted the announcement that Jerry
Thacker, an HIV-positive Christian activist who has referred to AIDS as a "gay
plague", would be appointed to the Presidential Advisory Commission on HIV and
AIDS. Three months before, a committee advising the Department of Health and
Human Services on protecting volunteers in clinical trials was asked to consider
whether embryos should be included within its remit (see Nature 420, 3–4; 2002)
— a move that critics saw as part of a wider anti-abortion agenda.
The controversy extends to committees that review grant applications.
Potential appointees to the panel advising the National Institute for
Occupational Safety and Health, for instance, were asked their views on office
safety standards — just one example, critics allege, of political considerations
impinging on appointments that should depend on scientific merit. The fear is
that scientists will refuse to serve on panels that are seen as rubber stamps
for administration policies, undermining the quality of the advice given to
government agencies and eroding public trust.
Some of the recent developments are disturbing. If the committee on human
research subjects gets bogged down discussing abortion politics instead of how
to protect patients in clinical trials, lives could be put at risk. Members of
committees reviewing grant applications should be selected for their scientific
expertise, not their political views.
But successive US administrations, both Republican and Democrat, have
packed advisory committees with scientists and other experts who share their
political outlook. This only becomes a major issue for the scientific community
when the views in question jar with its majority opinion, or the politicization
is blatant.
Those with long memories say that the present outcry is reminiscent of the
furore inspired by Ronald Reagan's administration in the early 1980s, when it
tried similar tactics with committees advising the Environmental Protection
Agency — then seen as a thorn in the side of the administration's pro-business
policies. This sorry episode alienated environmental scientists, but thankfully
the administration eventually backed off and most of the damage was repaired.
There is some comfort to be gained from the checks and balances inherent to
the system. The degree of transparency in the formulation of science-led policy
in the United States has few parallels in the rest of the world. It is rare
indeed for the public to be able to influence government decisions about who
sits on the panels and what they discuss. And so far, public input seems to be
having a positive effect — last week's storm led Thacker to withdraw from the
HIV panel.
This does not mean that the critics should relax. They should look back at
the actions of previous administrations to determine the extent to which the
current moves represent a departure from accepted practice. The National
Academies' Committee on Science, Engineering, and Public Policy is set to take
up these questions at its next meeting on 19 February, providing a welcome and
timely forum.
Scientists should fight undue attempts by the Bush administration to
politicize the advisory process, and extend the same scrutiny to future
administrations, whatever their political persuasion.
Macmillan MagazinesNature © Macmillan Publishers Ltd 2003 Registered No.
785998 England.
Greetings list members,
< This does not mean that the critics should relax.
o.k., i'm not relaxing and i want _all_ my ruminant-to-ruminant aka mad
cow feed ban violations since May 2002 to date, not just that token one from
Texas i posted today, that they let slip by for whatever reason...
Food and Drug Administration Dallas District 4040 North Central Expressway
Dallas, Texas 75204-3145
November 7, 2002
Re: 2003-DAL-WL- 05 WARNING LETTER CERTIFIED MAIL RETURN RECIEPT REQUESTED
Mr. Ronald A. Christensen President & General Manager Sunnymead Ranch,
Inc. Rt. 1, Box 49 Idalou, TX 79329
Dear Mr. Christensen:
An inspection of your feed mill located at Route 1, Idalou, Texas, was
conducted by Food and Drug Administration (FDA) Investigator Lisa Yoder on
September 9/11, 2002. The inspection found significant deviations from the
requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 -
Animal Proteins Prohibited in Ruminant Feed (21 C.F.R. 589.2000). This
regulation is intended to prevent the establishment and amplification of Bovine
Spongiform Encephalopathy (BSE). The deviations cause the feed for sheep (a
ruminant animal) manufactured at your facility to be adulterated within the
meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the
Act).
Animal feeds and feed ingredients containing any mammalian derived protein
(prohibited material), such as bovine meat and bone meal, are considered
potentially injurious to ruminant and public health. Therefore, the use of such
materials in ruminant feed causes the feed to be adulterated under Section
402(a)(4) of the Act.
Our inspection revealed that your firm manufactures feed for sheep, that
may contain residues of prohibited material. Your sheep feed is mixed in the
same equipment that is used for mixing chicken feed containing bovine meat and
bone meal. Your sheep, which are given this feed, are ultimately auctioned for
sale as food for human consumption.
A list of Inspectional Observations (FDA Form 483) was issued to your firm
and discussed with you at the conclusion of the inspection. The following
violations were observed during the inspection:
Failure to use clean-out procedures or other means adequate to prevent
carryover of protein derived from mammalian tissue to animal protein or feeds
that may be used for ruminants, 21 C.F.R. 589.2000(e)(1)(iii)(A) and (B).
Specifically, raw ingredients, such as soybean meal, limestone, dehydrated
alfalfa meal, and meat and bone meal (bovine) pass through shared equipment.
Your firm does not conduct any form of clean-out between delivery of meat and
bone meal and other feed ingredients like alfalfa meal, limestone, and soybean
meal used in both chicken and sheep formulas.
Additionally, there is no clean-out between batches of chicken feed which
contain the meat and bone meal and the sheep feed which is not intended to
contain the meat and bone meal.
Failure to maintain written clean-out procedures to prevent carryover of
protein derived from mammalian tissues to animal protein or feeds that may be
used for ruminants, 21 C.F.R. 589.2000(e)(l)(iv). Specifically, your firm does
not have any written clean-out procedure to prevent cross-contamination between
the sheep feed and the chicken feed nor do they practice/conduct any clean-out
procedures to prevent the cross-contamination between the chicken feed and sheep
feed.
The above is not intended to be an all-inclusive list of deficiencies by
your firm. As a feed manufacturer and ruminant feeder of sheep intended for
slaughter as food, you are responsible for ensuring that your operations are in
full compliance with the law. We have attached a copy of the BSE regulations to
assist you in meeting complete compliance under the law.
We are in receipt of your letter to this office dated September 13, 2002,
in which you state your "intent to not manufacture any sheep feed for the
immediate future." It is unclear to us from your letter whether you intend to
permanently discontinue manufacturing feed for sheep and whether you are now
purchasing ruminant feed from some other source. We cannot stress enough the
seriousness of these deficiencies, and the importance of your firm being in
complete compliance with the BSE regulations in regard to the mixing of ruminant
feed, and feeding and marketing of ruminant animals. Your firm must adhere to
the regulations to assure a safe ruminant feed and meat supply, or establish
complete and separate receiving, mixing, handling, and feeding conveyances and
equipment for ensuring such safety.
In your letter, you also indicated your unfamiliarity with the concept of
"residuals" of prohibited materials being carried over into ruminant feeds, and
you imply that discussions concerning residuals were not held with your firm
during FDA’s previous inspections. For your information, FDA conducted
inspections of your firm on July 27, 1999, and again on December 4, 2001 for
coverage of the BSE regulations. During both inspections, investigators
questioned your plant manager, John Brown, about the activities of your firm
relative to BSE, including specific questions addressing whether your firm was a
feeder of ruminant animals. During both inspections, it was also not conveyed to
our investigators that your firm raises sheep (for slaughter as food) at this
facility or manufactures feed for sheep. Therefore, during each of those
inspections no discussion was held regarding "residuals" of prohibited material
being carried over to ruminant feeds. We have attached copies of the following
FDA guidance documents for your review: FDA Guidance for Industry 68 - Small
Entities Compliance Guide -
Protein Blenders, Feed Manufacturers, and Distributors; Guide 69 - Feeders
of Ruminant Animals With On-Farm Feed Mixing Operations; Guide 70 - Feeders of
Ruminant Animals Without On-Farm Mixing Operations; and Guide 76 - Questions and
Answers BSE Feed Regulation.
You should take prompt action to correct these deviations, and establish
procedures whereby such violations do not recur. Failure to promptly correct
these deviations may result in regulatory action without further notice. Such
action could include, but is not limited to seizure and/or injunction.
You should notify this office in writing within fifteen (15) working days
of receipt of this letter of the specific actions taken to bring your firm in to
compliance with the law. Your response should include an explanation of each
step taken, including any plans to be taken to correct the violations that would
involve the continued use of the common mixing equipment for both sheep and
chicken feeds, and a timeframe for completion of the planned corrections. As
part of your written response, you should provide information regarding the
current feeding practices for sheep being kept at your facility, and information
about the current or planned marketing of such animals for slaughter.
Your written response should be directed to James R. Lahar, Compliance
Officer, at the above address. If you have any questions, you may contact Mr.
Lahar by telephone at (214) 253-5219.
Sincerely,
/s/
Reynaldo R. Rodriguez Jr. for Michael A. Chappell
Dallas District Director
===================================================
Subject: BSE--U.S. 50 STATE CONFERENCE CALL
Jan. 9, 2001 Date: Tue, 9 Jan 2001 16:49:00 –0800
From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy
BSE-L
snip...end
Date: Wed, 29 Jan 2003 12:26:10 -0600
Reply-To: Bovine Spongiform Encephalopathy
Sender: Bovine Spongiform Encephalopathy
From: "Terry S. Singeltary Sr."
Subject: MAD COW/SHEEP FEED BAN WARNING LETTER 'TEXAS' [holy madcow,
must have missed this one 11/7/02]
######## Bovine Spongiform Encephalopathy #########
greetings list members,
i'm still here, but i find it odd that they happen to slide this one by me?
i do not recall this one ever being posted on the TUESDAY warning letters
post??? regardless, i have it now, and so do you. also, this goes to show you of
my concern at the Jan. 9, 2001 BSE Emergency Conference call, when i stated how
shocked i was as to how many folks in the 'industry' knew nothing of the
supposedly 8/4/97 ruminant-to-ruminant voluntary feed ban. either they were
sincere about not knowing about it, or they were just all playing stupid and
simply ignoring it. either way, the consumer will now pay the fiddler for years
to come;
Food and Drug Administration Dallas District 4040 North Central Expressway
Dallas, Texas 75204-3145
November 7, 2002
Re: 2003-DAL-WL- 05 WARNING LETTER CERTIFIED MAIL RETURN RECIEPT REQUESTED
Mr. Ronald A. Christensen President & General Manager Sunnymead Ranch,
Inc. Rt. 1, Box 49 Idalou, TX 79329
Dear Mr. Christensen:
An inspection of your feed mill located at Route 1, Idalou, Texas, was
conducted by Food and Drug Administration (FDA) Investigator Lisa Yoder on
September 9/11, 2002. The inspection found significant deviations from the
requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 -
Animal Proteins Prohibited in Ruminant Feed (21 C.F.R. 589.2000). This
regulation is intended to prevent the establishment and amplification of Bovine
Spongiform Encephalopathy (BSE). The deviations cause the feed for sheep (a
ruminant animal) manufactured at your facility to be adulterated within the
meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the
Act).
Animal feeds and feed ingredients containing any mammalian derived protein
(prohibited material), such as bovine meat and bone meal, are considered
potentially injurious to ruminant and public health. Therefore, the use of such
materials in ruminant feed causes the feed to be adulterated under Section
402(a)(4) of the Act.
Our inspection revealed that your firm manufactures feed for sheep, that
may contain residues of prohibited material. Your sheep feed is mixed in the
same equipment that is used for mixing chicken feed containing bovine meat and
bone meal. Your sheep, which are given this feed, are ultimately auctioned for
sale as food for human consumption.
A list of Inspectional Observations (FDA Form 483) was issued to your firm
and discussed with you at the conclusion of the inspection. The following
violations were observed during the inspection:
Failure to use clean-out procedures or other means adequate to prevent
carryover of protein derived from mammalian tissue to animal protein or feeds
that may be used for ruminants, 21 C.F.R. 589.2000(e)(1)(iii)(A) and (B).
Specifically, raw ingredients, such as soybean meal, limestone, dehydrated
alfalfa meal, and meat and bone meal (bovine) pass through shared equipment.
Your firm does not conduct any form of clean-out between delivery of meat and
bone meal and other feed ingredients like alfalfa meal, limestone, and soybean
meal used in both chicken and sheep formulas.
Additionally, there is no clean-out between batches of chicken feed which
contain the meat and bone meal and the sheep feed which is not intended to
contain the meat and bone meal.
Failure to maintain written clean-out procedures to prevent carryover of
protein derived from mammalian tissues to animal protein or feeds that may be
used for ruminants, 21 C.F.R. 589.2000(e)(l)(iv). Specifically, your firm does
not have any written clean-out procedure to prevent cross-contamination between
the sheep feed and the chicken feed nor do they practice/conduct any clean-out
procedures to prevent the cross-contamination between the chicken feed and sheep
feed.
The above is not intended to be an all-inclusive list of deficiencies by
your firm. As a feed manufacturer and ruminant feeder of sheep intended for
slaughter as food, you are responsible for ensuring that your operations are in
full compliance with the law. We have attached a copy of the BSE regulations to
assist you in meeting complete compliance under the law.
We are in receipt of your letter to this office dated September 13, 2002,
in which you state your "intent to not manufacture any sheep feed for the
immediate future." It is unclear to us from your letter whether you intend to
permanently discontinue manufacturing feed for sheep and whether you are now
purchasing ruminant feed from some other source. We cannot stress enough the
seriousness of these deficiencies, and the importance of your firm being in
complete compliance with the BSE regulations in regard to the mixing of ruminant
feed, and feeding and marketing of ruminant animals. Your firm must adhere to
the regulations to assure a safe ruminant feed and meat supply, or establish
complete and separate receiving, mixing, handling, and feeding conveyances and
equipment for ensuring such safety.
In your letter, you also indicated your unfamiliarity with the concept of
"residuals" of prohibited materials being carried over into ruminant feeds, and
you imply that discussions concerning residuals were not held with your firm
during FDA’s previous inspections. For your information, FDA conducted
inspections of your firm on July 27, 1999, and again on December 4, 2001 for
coverage of the BSE regulations. During both inspections, investigators
questioned your plant manager, John Brown, about the activities of your firm
relative to BSE, including specific questions addressing whether your firm was a
feeder of ruminant animals. During both inspections, it was also not conveyed to
our investigators that your firm raises sheep (for slaughter as food) at this
facility or manufactures feed for sheep. Therefore, during each of those
inspections no discussion was held regarding "residuals" of prohibited material
being carried over to ruminant feeds. We have attached copies of the following
FDA guidance documents for your review: FDA Guidance for Industry 68 - Small
Entities Compliance Guide -
Protein Blenders, Feed Manufacturers, and Distributors; Guide 69 - Feeders
of Ruminant Animals With On-Farm Feed Mixing Operations; Guide 70 - Feeders of
Ruminant Animals Without On-Farm Mixing Operations; and Guide 76 - Questions and
Answers BSE Feed Regulation.
You should take prompt action to correct these deviations, and establish
procedures whereby such violations do not recur. Failure to promptly correct
these deviations may result in regulatory action without further notice. Such
action could include, but is not limited to seizure and/or injunction.
You should notify this office in writing within fifteen (15) working days
of receipt of this letter of the specific actions taken to bring your firm in to
compliance with the law. Your response should include an explanation of each
step taken, including any plans to be taken to correct the violations that would
involve the continued use of the common mixing equipment for both sheep and
chicken feeds, and a timeframe for completion of the planned corrections. As
part of your written response, you should provide information regarding the
current feeding practices for sheep being kept at your facility, and information
about the current or planned marketing of such animals for slaughter.
Your written response should be directed to James R. Lahar, Compliance
Officer, at the above address. If you have any questions, you may contact Mr.
Lahar by telephone at (214) 253-5219.
Sincerely,
/s/
Reynaldo R. Rodriguez Jr. for Michael A. Chappell
Dallas District Director
===================================================
Subject: Re: USA ruminant-to-ruminant feed ban warning letters (Advisory
Panels Stacked, Scientists Warn)
Date: Fri, 24 Jan 2003 08:37:49 –0600
From: "Terry S. Singeltary Sr."
To: Bovine Spongiform Encephalopathy References: <3e075c47 .3080506=".3080506" wt.net="wt.net"> <3e21ba6c .3040900=".3040900" wt.net="wt.net"> <3e23107a .433c64bf=".433c64bf" airtime.co.uk="airtime.co.uk"> 3E232ABD.8000005@wt.net
Advisory Panels Stacked, Scientists Warn
By J.R. Pegg
WASHINGTON, DC, January 23, 2003 (ENS) - American scientists are growing
increasingly worried that the Bush administration is manipulating scientific
advisory committees in order to further its political agenda.
The federal government relies on hundreds of these committees to provide
agencies with unbiased advice based on the best science available as well as to
peer review grant proposals for scientific research.
The Bush administration, many scientists fear, has distorted this process
by putting committee members through political litmus tests, eliminating
committees whose findings looked likely to disagree with its policies, and
stacking committees with individuals who have a vested interest in steering
conclusions to benefit effected industries.
scientist Scientist John Turner holds a beaker containing a solar cell
electrolyzer submerged in an alkaline aqueous solution. (Photo by Richard
Peterson courtesy NREL) "We've seen a consistent pattern of putting people in
who will ensure that the administration hears what it wants to hear," said Dr.
David Michaels, a research professor in the Department of Environmental and
Occupational Health at George Washington University's School of Public Health.
Addressing reporters at a press briefing today in Washington, Dr. Michaels said,
"That doesn't help science, and it doesn't help the country."
The Bush administration says it is doing what every other administration
has done in the past, but many scientists take issue with this defense.
"The Clinton administration did not do this," said Dr. Lynn Goldman, a
pediatrician and professor at the Bloomberg School of Public Health at Johns
Hopkins University. "They did not exclude people based on some sort of litmus
test." Goldman Pediatrician Dr. Lynn Goldman was assistant administrator of the
Office of Prevention, Pesticides and Toxic Substances of the U.S. EPA under the
Clinton administration. (Photo courtesy Johns Hopkins Magazine)
"These are not just the concerns of a few scientists or members of the
public health community but of a broad array of people across the country,"
added Kelly O'Brien, associate executive director of public affairs for the
American Public Health Association (APHA).
The role of these committees is not to tell the administration what they
want to hear, Michaels argues, but to tell them what science has concluded about
the issue under discussion.
"You hire political appointees to move your political agenda forward," he
observes. "But the role of scientific advisory committees is quite different. It
is to give advice to the agencies and to the public on what is the best
science."
"This is a threat to the fundamental principles that we want to make
decisions based on the best available science," Goldberg added.
Americans may be unfamiliar with the role of scientific advisory
committees, but the impact of the advice they give is extensive. Rules and
regulations that govern clean air, clean water, food safety and pesticide use,
among others, have been devised with scientific advice from such committees.
The growing concern from American scientists comes from a slew of examples.
Members of the Center for Disease Control's (CDC) Advisory Committee on
Childhood Lead Poisoning Prevention were replaced last year with individuals
with close ties to the lead industry, including Dr. William Banner, who has
provided written testimony on behalf of lead industry defendants in a lawsuit in
Rhode Island.
Banner is on record as believing that lead is only harmful in levels that
are seven to 10 times higher than the current CDC blood lead levels. The CDC
estimates some 890,000 U.S. children ages one to five have elevated levels of
lead in their blood.
Fifteen of the 18 members of the Advisory Committee to the Director of the
National Health Center for Environmental Health were replaced last year. This
committee assesses the health impact of exposure to environmental chemicals.
Among the new members is the former president of the Chemical Industry Institute
for Toxicology.
Thompson Health and Human Services Secretary Tommy Thompson (Photo courtesy
U.S. Government) Tommy Thompson, Secretary of the Department of Health and Human
Services (HHS), dissolved a committee charged with analyzing the federal system
for protecting human research subjects. A committee tasked with giving the U.S.
Food and Drug Administration advice on oversight of the genetics testing
industry was similarly disbanded.
A respected scientist nominated to serve on an HHS peer review study
section, which is charged with reviewing research grant proposals submitted to
the National Institute for Occupational Safety and Health, was rejected for her
support of an ergonomics rule overturned by the Bush administration last year.
A consultant to the Army Science Board was disapproved for full membership
on the committee because, he was told, he contributed to Senator John McCain's
campaign, an allegation that was false.
A new member of the Food and Drug Administration's Reproductive Health
Drugs Advisory Committee, Dr. David Hager, helped the Christian Medical
Association lobby for a safety review of a drug the committee approved two years
ago. The announcement that Hager, who has very few research credits, had been
put on the committee was released on Christmas Eve.
The trouble with this politicization of the process by which scientists
advise the government, Michaels explained, is that they will directly impact the
government's willingness to act.
"I don't think there is really any danger of a committee coming out and
making a statement so far out of the mainstream that it takes us in a different
direction," he explained. "What these committees will do, and I think this is
what the administration wants, is to essentially throw their hands up and say
there is too much uncertainty. That sort of paralysis is dangerous."
Apple Dr. Martin Apple (Photo courtesy University of Kansas Merrill
Advanced Studies Center) The trust the public has in science, and in the
scientific advice offered by the government for public health issues, could be
gravely affected by these developments, said Dr. Martin Apple, president of the
Council of Scientific Society Presidents.
"Public trust is like Humpty Dumpty," Apple said. "It is difficult to
establish, easy to lose and nearly impossible to restore."
It is not that anyone expects scientific advisory committee members to be
completely unbiased, Goldman said. Rather, it is critical that these committees
are focused only on the science, leaving political, economic and religious bias
out of the equation.
"If you attempt to predetermine the outcome of the scientific discussion by
selecting certain people for science committees or by constructing a consensus
before you bring the group together, then you are distorting the process,"
Goldman added. "For the past several months, again and again with this current
administration, we've seen evidence of this occurring."
Goldman, who served as the assistant administrator for the Office of
Prevention, Pesticide and Toxic Substances within the Environmental Protection
Agency (EPA) from 1993 to 1998, has firsthand experience with the Bush
administration's policy on scientific advisory committees. Goldman and two other
experts on the effects of pesticides on children were invited to speak at an EPA
funded conference that was scheduled for September 2002.
In July 2002, representatives from the pesticides industry wrote to the EPA
to protest the conference and specifically the participation of Goldman and the
other two scientists at the event. The EPA then rescheduled the conference for
June 2003 and has not re invited any of the three.
The overarching concern, Goldman said, is the apparent influence of the
pesticide industry on the EPA.
Waxman Congressman Henry Waxman has represented the Los Angeles area since
1974. (Photo courtesy Office of the Representative) California Representative
Henry Waxman, a Democrat, agreed and sent EPA Administrator Christie Todd
Whitman a letter on December 20, 2002 asking for an explanation by January 6,
2003.
Waxman's spokesperson Karen Lightfoot told ENS that the Congressman has not
received any response from the EPA.
In late October 2002, Waxman and 11 other members of Congress sent a letter
to HHS Secretary Thompson, detailing concern with "a pattern of events …
suggesting that scientific decision making is being subverted by ideology and
that scientific information that does not fit the administration's political
agenda is being suppressed."
HHS did reply to Waxman and his colleagues, but their explanations did not
satisfy the letter writers. A subsequent letter asking for more detailed
information was sent on December 18, 2002.
Lightfoot said there has been no response to the December 18 letter, but
added that Congressman Waxman will closely monitor "this trend of putting
ideology before science."
Groups like the American Public Health Association, which has some 50,000
members, are calling on Congress to further explore just what the Bush
administration is doing with scientific advisory committees. APHA drafted a
series of recommendations, including the reevaluation of newly reconstituted
advisory panels and the creation of criteria to guide the selection of members
on public health advisory committees and peer review research committees at all
levels of government - federal, state and local.
poster Poster for the Scientific Computing Division Advisory Panel convened
by the National Center for Atmospheric Research (Photo courtesy ) There is
concern that if the process continues forward without serious review that many
qualified scientists will decline to involve themselves with future committees.
"Scientists and the federal government in the United States have
established an effective system of providing expert advice," Apple said. "But
the best scientists are only willing to serve on such advisory groups when they
believe that they are unbiased and will produce scientifically sound results.
Once this currency is debased, the best scientists will decline to take the time
out from their lives to participate, and the government will lose an
irreplaceable resource."
"This will cause severe and last damage to the national interest and should
be actively prevented," Apple urged.
There is "no glory" for scientists to take part in the vast majority of
scientific advisory committees, Michaels said. They are only compensated for
travel and accommodations, and the work is often long and tedious.
"It is quite possible that these are isolated, anecdotal incidents,"
Goldman suggested. "But then why hasn't there been an attempt to rectify them?"
Copyright Environment News Service (ENS) 2003. All Rights Reserved.
Terry S. Singeltary Sr. wrote:
> ######## Bovine Spongiform Encephalopathy
> #########
>
> hello Dr. Dealler,
>
> please do not hold your breath for any USA
> ruminant-to-ruminant feed ban warning letters
> since May of 2002 to be released anytime soon,
> this could be fatal for you;-)
> i have not gotten them yet, if any exist.
> but i am trying.
> hopefully GW et al will not think i am one of
> the terrorist, and will allow for this information
> to be released (with no charge attached$$$)...
>
> kindest regards,
> terry
>
> Steve Dealler wrote:
>
>> ######## Bovine Spongiform Encephalopathy
>> #########
>>
>> This was absolutely excellent for Terry to have got this from the
US
>> Government...you should have tried getting this sort of thing from
>> MAFF in the UK
>> at the beginning of the nineties!
>> Steve Dealler
>>
>> "Terry S. Singeltary Sr." wrote:
>>
>>
>>> ######## Bovine Spongiform Encephalopathy
>>> #########
>>>
>>> Greetings List Members,
>>>
>>> as you know, i finally had to request to the FOIA
>>> for the USA madcow feed ban warning letters. so i thought
>>> some of you may be interested in an update on this matter.
>>>
>>> so here it is;
>>>
>>> Subject: Request to FDA via FOIA of ALL USA
Ruminant-to-Ruminant Feed
>>> Ban Violations Jan. 2001 to Jan. 2003
>>> Date: Mon, 6 Jan 2003 08:32:43 -0600
>>> From: "Terry S. Singeltary Sr."
>>> Reply-To: Bovine Spongiform Encephalopathy
>>> To: BSE-L
>>>
>>> Food and Drug Administration
>>> Office of Information Resources Management
>>> Division of Freedom of Information (HFI-35)
>>> 5600 Fishers Lane
>>> Rockville, MD 20857
>>>
>>> Or requests may be sent via fax to: (301) 443-1726. If there
are
>>> problems sending a fax, call (301) 443-2414.
>>>
>>> 1/6/03
>>>
>>> Request to FDA via FOIA of ALL USA Ruminant-to-Ruminant Feed
Ban
>>> Violations Jan. 2001 to Jan. 2003
>>>
>>> Greetings FDA and To Whom it may concern,
>>>
>>> i wish to request all ruminant-to-ruminant feed ban violations
from Jan.
>>> 2001 to Jan. 2003. it seems none has been posted since May
2001 on the
>>> FDA site. I also kindly request that all fees be wavered due
to the fact
>>> this is public information, public health is at risk, and this
>>> will be distributed 'freely' to the public...
>>>
>>> thank you,
>>> kind regards,
>>>
>>> I am sincerely,
>>>
>>> Terry S. Singeltary Sr.
>>> P.O. Box Bacliff, Texas USA 77518
>>> CJD Watch
>>> ==========================================================
>>>
>>> now since then, just this past Friday 1/10/03, i get this from
>>> FDA;
>>>
>>> REPLY FROM DPH/FDA to TSS;
>>>
>>> PLEASE note, my request was for all R-T-R feed ban
>>> violations from Jan. 2001 to Jan. 2003. BUT in the
>>> reply, they posted Jan. 2002 to Jan. 2003. i called
>>> and this is to be corrected. hopefully this FOIA
>>> request will ignite some enthusiasm from the FDA
>>> into posting to the public any R-T-R MAD COW
>>> FEED BAN violations, since GW et al new policy
>>> on secrecy took effect on this matter in May of 2002
>>> (correcting my below 'since May 2001).
>>>
>>> TSS
>>>
>>> Department of Health & Human Services
>>>
>>> Food and Drug Administration
>>> Rockville MD 20857
>>>
>>> 1/7/03
>>>
>>> In reply refer to;
>>>
>>> xxxxxxx
>>>
>>> Dear Requester,
>>>
>>> The Food and Drug Administration (FDA) has received your
>>> Freedom of Information Act (FOIA) request for records
>>> regarding;
>>>
>>> RUMINANT-TO-RUMINANT FEED - BAN VIOLATIONS 1/02 - 1/03
>>>
>>> We will respond as soon as possible and may charge you a fee
>>> for processing your request. If you have any questions
>>> about your request, please call Edna G. Wilkerson,
>>> Information Technician, at 301-827-6564 or write to us
>>> at;
>>>
>>> Food and Drug Administration
>>> Division of Freedom of Information
>>> 5600 Fishers Lance, HFI - 35
>>> Rockville, MD 20857
>>>
>>> If you call or write, use the reference number above
>>> which will help us to answer your questions more quickly...
>>> ===========================================================
>>> now, Sunday, i read this in the Houston Chronicle 1/12/03;
>>>
>>> SENATOR AIMS TO UPGRADE FREEDOM OF INFORMATION
>>>
>>> TEXAS Sen. John Coprnyn says he wants to improve public access
to
>>> government records in Washington, a position that appears to
put
>>> him at odds with the Bush administration.
>>>
>>> Cornyn, a moderate Republican who sits on the Senate Judiciary
>>> Committee, said he'll work on legislation in the coming weeks
to
>>> improve the Freedom of Information Act.
>>>
>>> "FOIA needs to be strenghened," he said, "We need to quicken
the
>>> turnaround time and create a mechanism that allows an
indepentent,
>>> third party to decide whether a record should be kept secret."
>>>
>>> Echoing sentiments he expressed while serving as Texas
attorney
>>> general, Cornyn added: "I believe in a system of governement
>>> that allows consent of the people. And people can't consent if
they
>>> don't what their elected officials are doing."
>>>
>>> Since taking office two years ago, the Bush Administration has
>>> taken steps to restrict access to governement information, an
effort
>>> that was accelerated in the name of national security
following
>>> the Sept. 11 terrorist attacks......
>>>
>>> Greetings again BSE-L list members,
>>>
>>> how would _USA_ ruminant-to-ruminant feed ban warning
>>> letters have anything to do with terrorism and National
>>> Security?
>>>
snip>>>
>>> Date: Wed, 2 Oct 2002 09:04:42 -0700
>>> Reply-To: Bovine Spongiform Encephalopathy
>>> Sender: Bovine Spongiform Encephalopathy
>>> From: "Terry S. Singeltary Sr."
>>> Subject: MAD COW FEED BAN WARNING LETTERS USA 'update' (where
did
>>> all Terry's MAD COW warning letters go?)
>>>
>>> snip...END...2012...TSS
snip...end...2012...TSS
----- Original Message -----
From: "Terry S. Singeltary Sr." flounder9@VERIZON.NET
To: BSE-L@aegee.org
Sent: Tuesday, November 07, 2006 11:21 AM
Subject: MAD COW FDA FEED WARNING LETTER NO. 2007-NOL-01 October 26, 2006
H.J. Baker & Bro., Inc.
##################### Bovine Spongiform Encephalopathy
#####################
Subject: MAD COW FDA FEED WARNING LETTER NO. 2007-NOL-01 October 26, 2006
H.J. Baker & Bro., Inc.
Date: November 7, 2006 at 9:08 am PST Food and Drug Administration
New Orleans District
404 BNA Drive, Building 200, Suite 500
Nashville, TN 37217
Telephone: 615-366-7801
Facsimile: 615-366-7802
October 26, 2006
WARNING LETTER NO. 2007-NOL-01
FEDERAL EXPRESS
OVERNIGHT DELIVERY
Mr. Christopher V. B. Smith
Corporate President, CEO
H. J. Baker & Bro., Inc.
228 Saugatuck Avenue
Westport, Connecticut 06880
Dear Mr. Smith:
On June 6, 8, 12-15, and 23, 2006, a U.S . Food and Drug Administration
(FDA) investigator inspected your animal feed protein supplement manufacturing
facility, located at 603 Railroad Avenue,Albertville, Alabama. The inspection
revealed significant deviations from the requirements set forth in Title 21,
Code ofFederal Regulations, Part 589.2000 (21 CFR 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 because they are adulterated
within the meaning of Section 402(a)(4) [21 USC 342(a)(4)] of the Federal Food,
Drug, and Cosmetic Act (the Act) and misbranded within the meaning of Section
403(a)(1) [21 USC 343(a)(1)] of the Act.
Our investigation determined adulteration resulted from the failure of your
firm to establish and implement measures sufficient to prevent commingling or
cross-contamination . The adulterated feed was subsequently misbranded because
it was not properly labeled. Specifically, we found :
" Your firm failed to establish and use cleanout procedures or other means
to prevent carry-over of products which contain or may contain protein derived
from mammalian tissues into animal protein or feeds which may be used for
ruminants, as required by 21 CFR 589.2000(e)(1)(iii)(B) .
Specifically, you failed to establish and use such measures for a screw
auger installed in February 2005 . This auger is used to convey both prohibited
and non-prohibited material to bulk storage bins.
In addition, you failed to follow the cleanout procedure your firm had
developed for the receiving systems. Your feed is, therefore, adulterated under
Section 402(a)(4) [21 USC 342(a)(4)] of the Act.
" You failed to label all products which contained or may have contained
prohibited materials with the BSE cautionary statement, "Do not feed to cattle
or other ruminants," as required by 21 CFR 589.2000(e)(1)(i) . Such products are
misbranded under Section 403(3) [21 USC 343(a)(1)] of the Act. These misbranded
products include the three Pro-Pak products mentioned below, as well as
Page 2 - H. J . Baker & Bro., Inc., Albertville, Alabama Warning Letter
No. 2007-NOL-O 1
those bulk loads of individual feed ingredients processed through this
common screw auger and distributed between the time it was installed in February
2005, and June 9, 2006 .
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 these violations, and you should
establish a system whereby violations do not recur.
Failure to promptly correct these violations may result in regulatory
action, such as seizure and/or injunction, without further notice.
We acknowledge your June 16, 2006, voluntary recall of three products you
manufactured from February 2005 to June 2006. The three products recalled were:
Pro-Lak Protein Concentrate for Lactating Dairy Animals; Pro-Amino II for
PreFresh and Lactating Cows; and, Pro-Pak Marine & Animal Protein
Concentrate for Use in Animal Feed.
Recall effectiveness checks and other measures will determine the merit of
this recall . We recognize you now label all products with the required BSE
cautionary statement and we also acknowledge your intent, given verbally to New
Orleans District management of the FDA, to discontinue the production of
supplements which do not contain prohibited materials. In your written response
to this letter, please confirm in writing you have taken these steps.
You should notify this office in writing within 15 working days of
receiving this letter, outlining the specific steps you have taken to bring your
firm into compliance with the law, including the steps we acknowledge above and
any additional steps you have taken. Your response should include an explanation
of each step taken to correct the violations and prevent their recurrence. If
corrective action cannot be completed within 15 working days, state the reason
for the delay and the date by which the corrections will be completed. Include
copies of any available documentation demonstrating corrections have been made.
Your reply should be directed to Kari L. Batey, Compliance Officer, at the
address above. If you have
questions regarding any issue in this letter, please contact Ms. Batey at
(615) 366-7808.
Sincerely,
,
Carol S . Sanchez
Acting District Director
New Orleans District
Enclosure: Form FDA 483
cc: Craig R. Waterhouse
Plant Manager
H.J. Baker & Bros., Inc.
603 Railroad Avenue
Albertville, Alabama 35951-3419
TSS
MORE 2006 FEED BAN VIOLATIONS BELOW, ''IN COMMERCE'' ;
Subject: MAD COW FEED RECALL USA SEPT 6, 2006 1961.72 TONS IN COMMERCE AL,
TN, AND WV
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
a) Dairy feed, custom, Recall # V-134-6;
b) Custom Dairy Feed with Monensin, Recall # V-135-6.
CODE
None. Bulk product
RECALLING FIRM/MANUFACTURER
Recalling Firm: Burkmann Feed, Greeneville, TN, by Telephone beginning on
June 28, 2006.
Manufacturer: H. J. Baker & Bro., Inc., Albertville, AL. Firm initiated
recall is complete.
REASON
Possible contamination of dairy feeds with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
1,484 tons
DISTRIBUTION
TN and WV
Subject: MAD COW FEED RECALLS ENFORCEMENT REPORT FOR AUGUST 9, 2006 KY, LA,
MS, AL, GA, AND TN 11,000+ TONS
Date: August 16, 2006 at 9:19 am PST
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II
______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-115-6
CODE
None
RECALLING FIRM/MANUFACTURER
Hiseville Feed & Seed Co., Hiseville, KY, by telephone and letter on or
about July 14, 2006. FDA initiated recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
Approximately 2,223 tons
DISTRIBUTION
KY
______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-116-6
CODE
None
RECALLING FIRM/MANUFACTURER
Rips Farm Center, Tollesboro, KY, by telephone and letter on July 14, 2006.
FDA initiated recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
1,220 tons
DISTRIBUTION
KY
______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-117-6
CODE
None
RECALLING FIRM/MANUFACTURER
Kentwood Co-op, Kentwood, LA, by telephone on June 27, 2006. FDA initiated
recall is completed.
REASON
Possible contamination of animal feed ingredients, including ingredients
that are used in feed for dairy animals, with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
40 tons
DISTRIBUTION
LA and MS
______________________________
PRODUCT
Bulk Dairy Feed, Recall V-118-6
CODE
None
RECALLING FIRM/MANUFACTURER
Cal Maine Foods, Inc., Edwards, MS, by telephone on June 26, 2006. FDA
initiated recall is complete.
REASON
Possible contamination of animal feed ingredients, including ingredients
that are used in feed for dairy animals, with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
7,150 tons
DISTRIBUTION
MS
______________________________
PRODUCT
Bulk custom dairy pre-mixes, Recall # V-119-6
CODE
None
RECALLING FIRM/MANUFACTURER
Walthall County Co-op, Tylertown, MS, by telephone on June 26, 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
87 tons
DISTRIBUTION
MS
______________________________
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 MI MAMMALIAN PROTEIN VOLUME OF PRODUCT IN
COMMERCE 27,694,240 lbs
Date: August 6, 2006 at 6:14 pm PST
PRODUCT
Bulk custom dairy feds manufactured from concentrates, Recall # V-113-6
CODE
All dairy feeds produced between 2/1/05 and 6/16/06 and containing H. J.
Baker recalled feed products.
RECALLING FIRM/MANUFACTURER
Vita Plus Corp., Gagetown, MI, by visit beginning on June 21, 2006. Firm
initiated recall is complete.
REASON
The feed was manufactured from materials that may have been contaminated
with mammalian protein.
VOLUME OF PRODUCT IN COMMERCE
27,694,240 lbs
DISTRIBUTION
MI
END OF ENFORCEMENT REPORT FOR AUGUST 2, 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
###
Subject: MAD COW FEED RECALL KY VOLUME OF PRODUCT IN COMMERCE ?????
Date: August 6, 2006 at 6:19 pm PST
PRODUCT
Bulk custom made dairy feed, Recall # V-114-6
CODE
None
RECALLING FIRM/MANUFACTURER
Burkmann Feeds LLC, Glasgow, KY, by letter on July 14, 2006. Firm initiated
recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak, which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
?????
DISTRIBUTION
KY
END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006
###
CJD WATCH MESSAGE BOARD
TSS
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
###
Subject: MAD COW FEED BAN WARNING LETTER ISSUED MAY 17, 2006 Date: June 27,
2006 at 7:42 am PST Public Health Service Food and Drug Administration
New Orleans District 297 Plus Park Blvd. Nashville, TN 37217
Telephone: 615-781-5380 Fax: 615-781-5391
May 17, 2006
WARNING LETTER NO. 2006-NOL-06
FEDERAL EXPRESS OVERNIGHT DELIVERY
Mr. William Shirley, Jr., Owner Louisiana.DBA Riegel By-Products 2621 State
Street Dallas, Texas 75204
Dear Mr. Shirley:
On February 12, 17, 21, and 22, 2006, a U.S. Food & Drug Administration
(FDA) investigator inspected your rendering plant, located at 509 Fortson
Street, Shreveport, Louisiana. The inspection revealed significant deviations
from the requirements set forth in Title 21, Code of Federal Regulations, Part
589.2000 [21 CFR 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; products being manufactured and distributed by your facility are
misbranded within the meaning of Section 403(a)(1) [21 USC 343(a)(1)] of the
Federal Food, Drug, and Cosmetic Act (the Act).
Our investigation found you failed to provide measures, including
sufficient written procedures, to prevent commingling or cross-contamination and
to maintain sufficient written procedures [21 CFR 589.2000(e)] because:
You failed to use clean-out procedures or other means adequate to prevent
carryover of protein derived from mammalian tissues into animal protein or feeds
which may be used for ruminants. For example, your facility uses the same
equipment to process mammalian and poultry tissues. However, you use only hot
water to clean the cookers between processing tissues from each species. You do
not clean the auger, hammer mill, grinder, and spouts after processing mammalian
tissues.
You failed to maintain written procedures specifying the clean-out
procedures or other means to prevent carryover of protein derived from mammalian
tissues into feeds which may be used for ruminants.
As a result . the poultry meal you manufacture may contain protein derived
from mammalian tissues prohibited in ruminant feed. Pursuant to 21 CFR
589.2000(e)(1)(i), any products containing or may contain protein derived from
mammalian tissues must be labeled, "Do not feed to cattle or other ruminants."
Since you failed to label a product which may contain protein derived from
mammalian tissues with the required cautionary statement. the poultry meal is
misbranded under Section 403(a)(1) [21 USC 343(a)(1)] of the Act.
This letter is not intended 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 these violations, and you should establish a system whereby violations
do not recur. Failure to promptly correct these violations may result in
regulatory action, such as seizure and/or injunction, without further notice.
You should notify this office in writing within 15 working days of
receiving this letter, outlining the specific steps you have taken to bring your
firm into compliance with the law. Your response should include an explanation
of each step taken to correct the violations and prevent their recurrence. If
corrective action cannot be completed within 15 working days, state the reason
for the delay and the date by which the corrections will be completed. Include
copies of any available documentation demonstrating corrections have been made.
Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S.
Food and Drug Administration, 2424 Edenborn Avenue, Suite 410, Metairie,
Louisiana 70001. If you have questions regarding any issue in this letter,
please contact Mr. Rivero at (504) 219-8818, extension 103.
Sincerely,
/S
Carol S. Sanchez Acting District Director New Orleans District
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.
PRION 2009 CONGRESS BOOK OF ABSTRACTS
O.4.3
Spread of BSE prions in cynomolgus monkeys (Macaca fascicularis) after oral
transmission
Edgar Holznagel1, Walter Schulz-Schaeffer2, Barbara Yutzy1, Gerhard
Hunsmann3, Johannes Loewer1 1Paul-Ehrlich-Institut, Federal Institute for Sera
and Vaccines, Germany; 2Department of Neuropathology, Georg-August University,
Göttingen, Germany, 3Department of Virology and Immunology, German Primate
Centre, Göttingen, Germany
Background: BSE-infected cynomolgus monkeys represent a relevant animal
model to study the pathogenesis of variant Creutzfeldt-Jacob disease (vCJD).
Objectives: To study the spread of BSE prions during the asymptomatic phase
of infection in a simian animal model.
Methods: Orally BSE-dosed macaques (n=10) were sacrificed at defined time
points during the incubation period and 7 orally BSE-dosed macaques were
sacrificed after the onset of clinical signs. Neuronal and non-neuronal tissues
were tested for the presence of proteinase-K-resistant prion protein (PrPres) by
western immunoblot and by paraffin-embedded tissue (PET) blot technique.
Results: In clinically diseased macaques (5 years p.i. + 6 mo.), PrPres
deposits were widely spread in neuronal tissues (including the peripheral
sympathetic and parasympathetic nervous system) and in lymphoid tissues
including tonsils. In asymptomatic disease carriers, PrPres deposits could be
detected in intestinal lymph nodes as early as 1 year p.i., but CNS tissues were
negative until 3 – 4 years p.i. Lumbal/sacral segments of the spinal cord and
medulla oblongata were PrPres positive as early as 4.1 years p.i., whereas
sympathetic trunk and all thoracic/cervical segments of the spinal cord were
still negative for PrPres. However, tonsil samples were negative in all
asymptomatic cases.
Discussion: There is evidence for an early spread of BSE to the CNS via
autonomic fibres of the splanchnic and vagus nerves indicating that
trans-synaptical spread may be a time-limiting factor for neuroinvasion. Tonsils
were predominantly negative during the main part of the incubation period
indicating that epidemiological vCJD screening results based on the detection of
PrPres in tonsil biopsies may mostly tend to underestimate the prevalence of
vCJD among humans.
P04.27
Experimental BSE Infection of Non-human Primates: Efficacy of the Oral
Route
Holznagel, E1; Yutzy, B1; Deslys, J-P2; Lasmézas, C2; Pocchiari, M3;
Ingrosso, L3; Bierke, P4; Schulz-Schaeffer, W5; Motzkus, D6; Hunsmann, G6;
Löwer, J1 1Paul-Ehrlich-Institut, Germany; 2Commissariat à l´Energie Atomique,
France; 3Instituto Superiore di Sanità, Italy; 4Swedish Institute for Infectious
Disease control, Sweden; 5Georg August University, Germany; 6German Primate
Center, Germany
Background:
In 2001, a study was initiated in primates to assess the risk for humans to
contract BSE through contaminated food. For this purpose, BSE brain was titrated
in cynomolgus monkeys.
Aims:
The primary objective is the determination of the minimal infectious dose
(MID50) for oral exposure to BSE in a simian model, and, by in doing this, to
assess the risk for humans. Secondly, we aimed at examining the course of the
disease to identify possible biomarkers.
Methods:
Groups with six monkeys each were orally dosed with lowering amounts of BSE
brain: 16g, 5g, 0.5g, 0.05g, and 0.005g. In a second titration study, animals
were intracerebrally (i.c.) dosed (50, 5, 0.5, 0.05, and 0.005 mg).
Results:
In an ongoing study, a considerable number of high-dosed macaques already
developed simian vCJD upon oral or intracerebral exposure or are at the onset of
the clinical phase. However, there are differences in the clinical course
between orally and intracerebrally infected animals that may influence the
detection of biomarkers.
Conclusions:
Simian vCJD can be easily triggered in cynomolgus monkeys on the oral route
using less than 5 g BSE brain homogenate. The difference in the incubation
period between 5 g oral and 5 mg i.c. is only 1 year (5 years versus 4 years).
However, there are rapid progressors among orally dosed monkeys that develop
simian v CJD as fast as intracerebrally inoculated animals.
The work referenced was performed in partial fulfillment of the study “BSE
in primates“ supported by the EU (QLK1-2002-01096).
Simian vCJD can be easily triggered in cynomolgus monkeys on the oral route
using less than 5 g BSE brain homogenate.
look at the table and you'll see that as little as 1 mg (or 0.001 gm)
caused 7% (1 of 14) of the cows to come down with BSE;
Risk of oral infection with bovine spongiform encephalopathy agent in
primates
Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog,
Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia, Nathalie
Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-Philippe
Deslys Summary The uncertain extent of human exposure to bovine spongiform
encephalopathy (BSE)--which can lead to variant Creutzfeldt-Jakob disease
(vCJD)--is compounded by incomplete knowledge about the efficiency of oral
infection and the magnitude of any bovine-to-human biological barrier to
transmission. We therefore investigated oral transmission of BSE to non-human
primates. We gave two macaques a 5 g oral dose of brain homogenate from a
BSE-infected cow. One macaque developed vCJD-like neurological disease 60 months
after exposure, whereas the other remained free of disease at 76 months. On the
basis of these findings and data from other studies, we made a preliminary
estimate of the food exposure risk for man, which provides additional assurance
that existing public health measures can prevent transmission of BSE to man.
snip...
BSE bovine brain inoculum
100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mg
Primate (oral route)* 1/2 (50%)
Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%)
1/15 (7%)
RIII mice (ic ip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%)
PrPres biochemical detection
The comparison is made on the basis of calibration of the bovine inoculum
used in our study with primates against a bovine brain inoculum with a similar
PrPres concentration that was
inoculated into mice and cattle.8 *Data are number of animals
positive/number of animals surviving at the time of clinical onset of disease in
the first positive animal (%). The accuracy of
bioassays is generally judged to be about plus or minus 1 log. ic
ip=intracerebral and intraperitoneal.
Table 1: Comparison of transmission rates in primates and cattle infected
orally with similar BSE brain inocula
Published online January 27, 2005
Calves were challenged by mouth with homogenised brain from confirmed cases
of BSE. Some received 300g (3 doses of 100g), some 100g, 10g or 1g. They were
then left to develop BSE, but were not subjected to the normal stresses that
they might have encountered in a dairy herd. Animals in all four groups
developed BSE. There has been a considerable spread of incubation period in some
of the groups, but it appears as if those in the 1 and 10g challenge groups most
closely fit the picture of incubation periods seen in the epidemic. Experiments
in progress indicate that oral infection can occur in some animals with doses as
low as 0.01g and 0.001g. .........
It is clear that the designing scientists must also have shared Mr
Bradley's surprise at the results because all the dose levels right down to 1
gram triggered infection.
6. It also appears to me that Mr Bradley's answer (that it would take less
than say 100 grams) was probably given with the benefit of hindsight;
particularly if one considers that later in the same answer Mr Bradley expresses
his surprise that it could take as little of 1 gram of brain to cause BSE by the
oral route within the same species. This information did not become available
until the "attack rate" experiment had been completed in 1995/96. This was a
titration experiment designed to ascertain the infective dose. A range of
dosages was used to ensure that the actual result was within both a lower and an
upper limit within the study and the designing scientists would not have
expected all the dose levels to trigger infection. The dose ranges chosen by the
most informed scientists at that time ranged from 1 gram to three times one
hundred grams. It is clear that the designing scientists must have also shared
Mr Bradley's surprise at the results because all the dose levels right down to 1
gram triggered infection.
2012
***Also, a link is suspected between atypical BSE and some apparently
sporadic cases of Creutzfeldt-Jakob disease in humans. These atypical BSE cases
constitute an unforeseen first threat that could sharply modify the European
approach to prion diseases.
Second threat
snip...
MAD COW USDA ATYPICAL L-TYPE BASE BSE, the rest of the story...
***Oral Transmission of L-type Bovine Spongiform Encephalopathy in Primate
Model
***Infectivity in skeletal muscle of BASE-infected cattle
***feedstuffs- It also suggests a similar cause or source for atypical BSE
in these countries.
***Also, a link is suspected between atypical BSE and some apparently
sporadic cases of Creutzfeldt-Jakob disease in humans.
The present study demonstrated successful intraspecies transmission of
H-type BSE to cattle and the distribution and immunolabeling patterns of PrPSc
in the brain of the H-type BSE-challenged cattle. TSE agent virulence can be
minimally defined by oral transmission of different TSE agents (C-type, L-type,
and H-type BSE agents) [59]. Oral transmission studies with H-type BSEinfected
cattle have been initiated and are underway to provide information regarding the
extent of similarity in the immunohistochemical and molecular features before
and after transmission.
In addition, the present data will support risk assessments in some
peripheral tissues derived from cattle affected with H-type BSE.
2012 CALIFORNIA ATYPICAL L-TYPE BASE BSE MAD COW, SPONTANEOUS AND FEED $$$
Saturday, May 26, 2012
Are USDA assurances on mad cow case 'gross oversimplification'?
SNIP...
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
The argument about feed is critical because if feed is the cause, not a
spontaneous mutation, the California cow could be part of a larger outbreak.
SNIP...
in the url that follows, I have posted
SRM breaches first, as late as 2011.
then
MAD COW FEED BAN BREACHES AND TONNAGES OF MAD COW FEED IN COMMERCE up until
2007, when they ceased posting them.
then,
MAD COW SURVEILLANCE BREACHES.
Friday, May 18, 2012
Update from APHIS Regarding a Detection of Bovine Spongiform Encephalopathy
(BSE) in the United States Friday May 18, 2012
Wednesday, May 30, 2012
PO-028: Oral transmission of L-type bovine spongiform encephalopathy
(L-BSE) in primate model Microcebus murinus
Saturday, August 4, 2012
Final Feed Investigation Summary - California BSE Case - July 2012
Friday, December 14, 2012
Susceptibility Chronic Wasting Disease (CWD) in wild cervids to Humans 2005
- December 14, 2012
***Monday, March 26, 2012
CANINE SPONGIFORM ENCEPHALOPATHY: A NEW FORM OF ANIMAL PRION DISEASE
http://caninespongiformencephalopathy.blogspot.com/2012/03/canine-spongiform-encephalopathy-new.html
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
From: Terry S. Singeltary Sr. To: CVMHomeP@cvm.fda.gov Cc:
FOIASTAFF@oig.usda.gov ; paffairs@oig.hhs.gov ; HHSTips@oig.hhs.gov ;
phyllis.fong@oig.usda.gov
FOIA REQUEST ON FEED RECALL PRODUCT 429,128 lbs. feed for ruminant animals
may have been contaminated with prohibited material Recall # V-258-2009
September 4, 2009
TO:
Food and Drug Administration
Division of Freedom of Information (HFI-35)
Office of Shared Services
Office of Public Information and Library Services
5600 Fishers Lane
Rockville, MD 20857
Or requests may be sent via fax to: fax number 301-443-1726 or
301-443-1719. If experience difficulty sending a fax, please call (301)
443-2414.
FROM:
Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518
Greetings FDA FOIE, and the Honorable Phyllis Fong et al @ OIG FOIA,
ANOTHER FOIA REQUEST PLEASE !
PLEASE SEE FULL TEXT ;
Canine Spongiform Encephalopathy CSE TSE
>>> Is anybody even looking at the dogs..especially with CWD now
so widespread? <<<
NA, na, na........they know what they will find, Canine Spongiform
Encephalopathy, and it was documented, but then they decided not to push the
issue anymore, they had enough mad cow disease in different species to deal
with. so they screwed the brains up with dogs and deer in the UK. then we took a
page or two from the UKs testing protocols and USDA screwed the brains up with
cattle, again, and again, and again. then played the stupid card. ya can't fix
stupid. ... TSS
Monday, March 8, 2010
Canine Spongiform Encephalopathy aka MAD DOG DISEASE
Greetings,
Another Big Myth about Transmissible Spongiform Encephalopathy, is that TSE
will not transmit to dogs. This is simply NOT TRUE. IT is perfectly legal to
feed dogs and cats here in the USA bovine meat and bone meal. Canine dementia is
real. how many dogs and cats here in the USA are tested for mad cow disease ? I
just received this F.O.I.A. request, and thought I would post it here with a
follow up on MAD DOG DISEASE. This is a follow up with additional data I just
received on a FOIA request in 2009 ;
see full text, and be sure to read the BSE Inquiry documents toward the
bottom ;
http://caninespongiformencephalopathy.blogspot.com/2010/03/canine-spongiform-encephalopathy-aka.html
Monday, March 8, 2010
UPDATE 429,128 lbs. feed for ruminant animals may have been contaminated
with prohibited material Recall # V-258-2009
Monday, March 1, 2010
ANIMAL PROTEIN I.E. MAD COW FEED IN COMMERCE A REVIEW 2010
layperson
MOM DOD 12/14/97 CONFIRMED hvCJD...TSS
TSS
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