Follow Ups | Post Followup | Back to Discussion Board | VegSource

From: TSS ()
Subject: Re: cattletoday.com CENSORS TSS ON BSE AKA MAD COW
Date: March 21, 2006 at 2:21 pm PST

In Reply to: Re: cattletoday.com CENSORS TSS ON BSE AKA MAD COW posted by TSS on March 21, 2006 at 2:17 pm:

> ----- Original Message -----
> From: "Terry S. Singeltary Sr."
> To:
> Sent: Friday, March 10, 2006 8:19 PM
> Subject: Substances Prohibited from Use in Animal Food or Feed, Proposed
> Rule, Docket No. 2002N-0273 C-534 VOL 45 (PhRMA) and Entered On February
17,
> 2006
>
>
> ##################### Bovine Spongiform Encephalopathy
> #####################
>
>
> Subject: Substances Prohibited from Use in Animal Food or Feed, Proposed
> Rule, Docket No. 2002N-0273 C-534 VOL 45 (PhRMA) and Entered On February
17,
> 2006
> Date: March 10, 2006 at 5:50 pm PST
>
>
> Subject: Substances Prohibited from Use in Animal Food or Feed, Proposed
> Rule, Docket No. 2002N-0273 C-534 VOL 45 (PhRMA) and Entered On February
17,
> 2006
> Date: March 10, 2006 at 5:23 pm PST
>
> Marie A. Vodicka, PhD
>
> Assistant Vice President
>
> Biologics & Blotechnology
>
> Scientlflc & Regulatory Affairs
>
> SCIENCE & REG AFFAIRS
>
> Division of Dockets Management (HFA-305)
>
> Food and Drug Administration
>
> 5630 Fishers Lane, rrn . 1061
>
> Rackville, MD 20862
>
>
> Re: Substances Prohibited from Use in Animal Food or Feed, Proposed Rule,
> Docket
>
> No. 2002N-0273
>
> February 14, 2006
>
> Dear Sir or Madam :
>
> The Pharmaceutical Research and Manufacturers of America (PhRMA) is
> providing
>
> comment to the proposed rules issued. by the Food and Drug Administration
> (FDA)
>
> Center for Veterinary Medicine (CVM) entitled Substances Prohibited From
Use
> in
>
> Animal Food or Feed ; Proposed Rule, 21 CFR Part 589; 70 Federal Register
> 58570
>
> (October 6, 2005). PhRMA applauds the FDA's continued actions to protect
the
> cattle
>
> population of the United States from BSE (bovine spongiform
encephalopat.hy)
> and, as
>
> discussed further below, strongly supports additional safeguards in
addition
> to those
>
> proposed in amended 21 CFR Part 589_
>
> PhRMA represents the country's leading research-based pharmaceutical and
>
> biotechnology companies, which are devoted to inventing medicines that
allow
> patients
>
> to lead longer, healthier and more productive lives. Investing more than
$30
> billion
>
> annually in discovering and developing new medicines, PhRMA companies are
> leading
>
> the way in the search for cures .
>
> Animal-derived materials are ubiquitous in our lives and have many
important
> uses .
>
> They are often used in pharmaceutical manufacturing and are sourced
> according to
>
> Pharmaceutical Research and Manufacturers of America
>
> Page 2of7
>
> guidelines issued by regulatory authorities and the specifications
outlined
> by the quality
>
> systems of the pharmaceutical company. The BSE status of the country where
> the
>
> animal lived and an assessment of the controls in place to prevent the
> spread of the
>
> disease, if it should occur, are important considerations in sourcing
> bovine-derived
>
> materials . While a country may have animals diagnosed with BSE,
evaluation
> of the
>
> measures put in place to halt the spread of the disease is as crucial as
> identification of
>
> the disease itself. PhRMA continues to support an internationally
> harmonized, sciencebased
>
> approach to determining appropriate safeguards against BSE. PhRMA believes
>
> that FDA efforts to communicate these science-based concepts to our
trading
> partners
>
> worldwide are critical. It is just as important to institute sound
> science-based policies in
>
> order to stop the spread of disease.
>
> Consideration of the safeguards enacted in the various countries where
> ruminant derived
>
> raw materials are sourced provides the underpinning for regulatory
guidance.
>
> The cattle population of the United States must continue to be an
acceptable
> source of
>
> bovine-derived raw materials for human food and pharmaceutical
> manufacturing. As
>
> such, continual re-evaluation of existing safeguards against BSE must
occur
> based on
>
> new information and advances in science . Due to confirmation that BSE is
> indeed
>
> present in North America, rapid implementation of enhanced safeguards for
> cattle and
>
> animal feed is required .
>
> We continue to be concerned about the amount of time it has taken the
Center
> for
>
> veterinary Medicine (CVM) to institute any changes to the 1997 feed ban; a
> lot has
>
> happened since 1997, not the least of which is the identification of a BSE
> cow native to
>
> the United States (June 2004). As we have urged for many years, the 1997
> feed ban
>
> must be enhanced based on new information, including the experimental
> results that
>
> Page 3 of 7
>
> show as little as 0.001 gram of infected tissue fed orally to cattle may
> result in BSE
>
> infection of cattle1.
>
> PhRMA supports actions of the Food and Drug Administration Center for
> Veterinary
>
> Medicine (FDA CVM ) to extend certain provisions in the 1997 Ruminant to
> Ruminant
>
> feed ban to all animal feed . As noted in the 1997 ruminant feed final
rule
> (§ 589.2000)
>
> and described in the October 6, 2005 Federal Register notice,2 the use of
> mammalian
>
> derived proteins is currently prohibited in ruminant feed, with the
> exception of certain
>
> proteins believed not to pose a risk of BSE transmission . These
exceptions
> to the
>
> definition of "protein derived from mammalian tissues" include: blood and
> blood
>
> products; gelatin; inspected meat products which have been cooked and
> offered for
>
> human food and further heat processed for feed (such as plate waste and
used
>
> cellulosic food casings), referred to herein as "plate waste" ; milk
> products (milk and
>
> milk protein) ; and any product whose only mammalian protein consists
> entirely of
>
> porcine or equine protein. The 1997 ruminant feed final rule does not
> prohibit ruminant
>
> animals from being fed processed animal proteins derived from
non-mammalian
>
> species (e .g ., avian or aquatic animals). The 1997 ruminant feed final
> rule permits the
>
> manufacture of non-ruminant feed containing prohibited mammalian protein
and
>
> ruminant feed on the same premises, provided that separate equipment is
used
> in the
>
> production of ruminant feed or that documented adequate clean-out
procedures
> are
>
> used between production batches .
>
> PhRMA has commented numerous times on the inadequacy of the 1997 feed ban
> (our
>
> latest comments were provided to Federal Register Docket 2004N-0264 and
> dated
>
> August 12, 2004). We stated that the current exemptions in the feed ban
must
> be
>
>
>
> http://www.defra.gov.uk/animalh/bse/science-research/pathog.html#dose
>
>
>
>
>
> " Federal Register. Docket 20Gi2N-0273_ Vol. 70, No. 193 58570-58601 .
Part
> IZi, Department of Health and Human Services, FDA 21CFR5$9 Subsianecs
> Prohlbired from Use ill Animal Food or Feed; Proposed Rule
>
> Page 4 of 7
>
> critically examined in light of the identification of BSE positive animals
> in Canada,
>
> Washington, and subsequently in Texas. Over the last few years, PhRMA has
> urged
>
> that serious consideration be given to prohibiting all specified risk
> material (SRM) in
>
> rendered product used for non-ruminant feed due to the potential for "on
> farm" cross
>
> contamination with feed designated for ruminants . We have strongly
> recommended
>
> implementation of measures to ensure that SRM is excluded from all animal
> feed . In
>
> addition, PhRMA urged the complete removal of the exception for ruminant
> blood and
>
> the exemptions for plate waste and poultry litter from the ruminant feed
> ban. As such,
>
> we strongly support the current FDA position to eliminate SRM from all
> animal feed and
>
> urge its immediate implementation. This safeguard must be implemented
> rapidly.
>
> Regrettably, FDA proposes to eliminate only the brain and spinal cord from
> cattle 30
>
> months of age or older, not the complete list of SRMs currently designated
> for human
>
> food . Given the absence of a species barrier when non-ruminant feed is
fed
>
> (inadvertently or deliberately) to ruminants, we urge the FDA to
reconsider
> its position
>
> and eliminate the complete list of SRM from all animal feed.
>
> We are steadfast in our position urging the removal of the exemption for
> plate waste
>
> and poultry litter . This position is based on the lack of species barrier
> and the inclusion
>
> of tissues with potentially high levels of infectivity present in plate
> waste and poultry
>
> litter . Allowing the exception for plate waste provides a direct route
for
> feeding
>
> ruminants to ruminants because plate waste may contain uneaten food items
> such as
>
> T-bone steak waste, including bone innervated with dorsal root ganglia
> (DRG). The
>
> absence of a species barrier when feeding ruminants to ruminants would
> facilitate the
>
> transmission of infectivity by the demonstrated high titer DRG, if
> infectivity were
>
> present . We have evaluated the rationale provide by FDA CVM for not
banning
> plate
>
> waste (in summary: SRMs are prohibited in human food therefore plate waste
> will not
>
> contain SRMs and can be fed back to cattle). This rationale does not take
> into account
>
> the lack of a species barrier when feeding cattle plate waste containing
> beef. The lack
>
> Page 5 of 7
>
> of a species barrier, coupled with the definition of SRMs limited to cows
> over 30 months
>
> of age, combined with the knowledge that there is circulating BSE agent
> (albeit at
>
> exceedingly low levels) in North America, are strong reasons to completely
> ban the
>
> feeding of plate waste to bovines . In addition, the FDA states in the
> proposed rules that
>
> they do not have an estimate of the amount of plate waste added to bovine
> feed, but
>
> the available anecdotal information states that the amount is not
> significant. If there is
>
> only a limited amount of plate waste being processed to bovine feed, given
> the lack of
>
> species barrier, it appears logical to prohibit the use of plate waste
> completely. PhRMA
>
> does not agree that eliminating all plate waste from bovine feed is an
> 'unnecessary
>
> measure' and we strongly urge CVM to reevaluate its position.
>
> Both specified risk materials (SRM) and plate waste are currently allowed
in
> poultry
>
> feed. We recommend that both SRM and plate waste be removed from poultry
> feed so
>
> that poultry litter can be used as a bovine nitrogen source. If these
> materials are not
>
> removed from poultry feed, then we recommend that poultry litter be banned
> from the
>
> diet of cattle.
>
> The proposed rule contains a provision to utilize certain dead cattle in
> animal feed.
>
> Allowing deadstock (dead, down, disabled, diseased) into the animal food
> chain if the
>
> brain and spinal cords have been removed does not take into account that
> these
>
> animals are the most likely to harbor infectivity as symptoms of BSE
disease
> confound
>
> the segregation of these animals. The total amount of infectivity does not
> reside in the
>
> brain and spinal cord and removal of these tissues does not make the
> remainder of the
>
> carcass acceptable to process into animal feed . According to risk
> assessment models,
>
> adult cattle deadstock are the population harboring the majority of the
> potential
>
> Page 6 of 7
>
> infectivity if BSE were! circulating in a population 3. Elimination of the
> deadstock from the
>
> animal food chain is critical to prevent the spread of disease.
>
> The other exemptions in the 1997 feed ban such as blood and milk/milk
> products are
>
> less problematic as Iong as milk and blood are sourced to prevent
> cross-contamination
>
> with high infiectivity tissues. We agree with the FDA's approach to these
> two tissues if
>
> the potential for cross-contamination is minimized .
>
> In summary, we recognize the tremendous efforts CVM has expended on
defining
> a
>
> strategy for enhanced feed controls in the United States to help stop the
> spread of
>
> BSE. The thoughtful evaluation of all comments as a result of the
> publication of the
>
> Advance Notice of Public Rule Making (July 14, 2004) reflects an Agency
> attempting to
>
> balance the risks of continuing current feeding practices with the
practical
>
> considerations of various industries . We appreciate a risk based approach
> but have
>
> misgivings about the level of safeguards contained in the proposed rule.
>
> To reiterate, our main concerns center on the following three issues - the
> narrow
>
> definition of the SRM to be excluded from non-ruminant feed, instead of a
> complete ban
>
> as for ruminant feed; the continued allowance of plate waste and poultry
lit
> ter in
>
> ruminant feed and finally, the provision to allow certain deadstock cattle
> into the animal
>
> food chain .
>
> PhRMA appreciates the opportunity to comment on the proposed changes to
the
>
> ruminant feed ban and the implementation of controls on non-ruminant feed_
> PhRMA
>
> member companies manufacture human medicines using a wide variety of
> materials .
>
> We continue to source animal derived raw materials according to
regulations
> of FDA
>
> Page 7 of 7
>
> and the quality systems of the company. The United States must continue to
> be
>
> recognized as an acceptable source of these animal derived raw materials
> both
>
> domestically and by our international trading partners . Using sound
science
> to
>
> influence regulatory approaches to animal husbandry is the key to
preventing
> the
>
> spread of BSE in the United States. FDA and USDA have already done a lot
to
> protect
>
> the United States but more must be done as reflected in our comments
herein
> . Please
>
> contact me if you have any questions or would like to arrange a meeting to
> discuss our
>
> comments.
>
> Sincerely,
>
> Marie A. Vodicka, PhD
>
>
>
>
>
>
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000534-01-vol45.p
> df
>
>
>
>
>
>
>
> Date: Fri, 20 Jan 2006 11:54:28 -0600
> Reply-To: Bovine Spongiform Encephalopathy
> Sender: Bovine Spongiform Encephalopathy
> From: "Terry S. Singeltary Sr."
> Subject: Docket No: 2002N-0273 (formerly Docket No. 02N-0273) Substances
> Prohibited From Use in Animal Food and Feed PAUL BROWN
>
>
>
> ##################### Bovine Spongiform Encephalopathy
#####################
>
>
> Subject: Docket No: 2002N-0273 (formerly Docket No. 02N-0273) Substances
> Prohibited From Use in Animal Food and Feed PAUL BROWN
> Date: January 20, 2006 at 9:31 am PST
>
> December 20,2005
>
> Division of Dockets Management (HFA-305)
>
> Food and Drug Administration
>
> 5630 Fishers Lane
>
> Room 1061
>
> Rockville, MD 20852
>
> Re: Docket No: 2002N-0273 (formerly Docket No. 02N-0273)
>
> Substances Prohibited From Use in Animal Food and Feed
>
> Dear Sir or Madame:
>
> As scientists and Irecognized experts who have worked in the field of TSEs
> for
>
> decades, we are deeply concerned by the recent discoveries of indigenous
BSE
> infected
>
> cattle in North America and appreciate the opportunity to submit comments
to
> this very
>
> important proposed rule We strongly supported the measures that USDA and
FDA
>
> implemented to protect public health after the discovery of the case of
> bovine spongiform
>
> encephalopathy (BSE) found in Washington State in 2003. We know of no
event
> or
>
> discovery since then that could justify relaxing the existing specified
risk
> material
>
> (SRM) and non-ambulatory bans and surveillance that were implemented at
that
> time.
>
> Further, we strongly supported the codification of those changes, as well
as
> additional
>
> measures to strengthen the entire feed and food system. The discovery of
> additional
>
> cases of indigenous BSE in North America since that time has validated our
> position and
>
> strengthened OUT convictions.
>
> We caution against using the 18 month enhanced surveillance as a
> justification to relax or
>
> impede further actions. While this surveillance has not uncovered an
> epidemic, it does
>
> not clear the US cattle herd from infection. While it is highly likely
that
> US and
>
> Canadian cattle were exposed to BSE prior to the 1997 feed ban, we do not
> know how
>
> many cattle were infected or how widely the infection was dispersed. BSE
> cases are
>
> most likely clustered in time and location, so while enhanced surveillance
> provides an 18
>
> month snapshot, it does uot negate the fact that US and Canadian cattle
were
> exposed to
>
> BSE. We also do not know in any quantitative or controlled way how
effective
> the feed
>
> ban has been, especially at the farm level. At this point we cannot even
> make a thorough
>
> assessment of the USDA surveillance as details such as age, risk category
> and regional
>
> distribution have not been released.
>
> A number of countries initially attempted to take partial steps in regard
to
> feed controls
>
> only to face repeated disappointments in predicted downturns of the
epidemic
> course.
>
> We in North America could do this experiment all over again, waiting for
> each new
>
> warning before adding more stringency to our control measures, or we can
> benefit from
>
> the experience of others and take decisive measures now to arrest any
> further
>
> development of underlying cases that is implicit in those already
discovered
> to date.
>
> The discovery of 5 indigenous North American cases, including one born
after
> the
>
> implementation of the current feed ban, should provide the necessary
> incentive to
>
> implement, monitor and enforce a comprehensive and protective feed ban
that
> is more
>
> congruent with the measures that have been proven to be effective
throughout
> the world.
>
> In particular, we urge the FDA to act without f&ther delay to strengthen
the
> animal feed
>
> regulations by implementing the program proposed by the Canadian Food
> Inspection
>
> Agency (CFIA) in the December 11, 2004 Gazette. This includes removing all
> specified
>
> risk materials (SRMs) and deadstock from all animal feed. We also urge
that
> the FDA
>
> discontinues the legal exemptions which allow ruminant protein to be fed
> back to
>
> ruminants (with the excelption of milk). Many of these exemptions do not
> exist in other
>
> countries.
>
> Bovine products and byproducts are used for both food and pharmaceuticals.
> These
>
> human uses require the highest level of safety. Because of the hardy
nature
> of the BSE
>
> agent and its high potential for cross contamination, the most effective
way
> to protect
>
> bovine products and bovine derived materials from contamination by BSE is
to
> ensure
>
> that infected animals or carcasses never enter processing plants. The goal
> would be to
>
> discover and remove infected animals fi-om production as early as possible
> in the
>
> infection and long before they wouid be sent to slaughter. Until we have
> diagnostic tools
>
> powerful enough to allow us to discover the disease early in its prolonged
> pre-clinical
>
> incubation, we have to rely on the next best strategy which is to prevent
> any exposure
>
> through feed. The exemptions in the current ban as well as in the newly
> proposed rule
>
> make this difficult if not impossible, as they still provide legal avenues
> for ruminants to
>
> consume potentially contaminated ruminant protein.
>
> It is our opinion that the Iproposed rule falls woetilly short in
effective
> measures to
>
> minimize the potential for further transmissions of the disease. By the
FDA’
> s own
>
> analysis, exempted tissues (such as distal ileum, DRGs, etc) contain
> approximately 10%
>
> of the infectivity in affected animals. Thus the proposed rule still
allows
> the possibility
>
> for cattle to be exposed to BSE through:
>
> 1. Feeding of materials currently subject to legal exemptions from the ban
> (e.g.,
>
> poultry litter, plate waste)
>
> 2. Cross feeding (the feeding of non-ruminant rations to runiinants) on
> farms; and
>
> 3. Cross contamination of ruminant and non-ruminant feed
>
> We are most concerned that the FDA has chosen to include a provision that
> would allow
>
> tissues from deadstock into the feed chain. We do not believe that down or
> dead stock
>
> E-d
>
> should be allowed into the food or feed chain whatever the age of the
animal
> and whether
>
> or not the CNS tissues are removed. We do not support the provision to
allow
> removal of
>
> brain and spinal cord from deadstock over 30 months for a number of
reasons.
> This
>
> category of animals contains the highest level of infectivity and that
> infectivity is in other
>
> tissues besides just brain and spinal cord. Recent improvements in the BSE
> bioassay,
>
> have now made it possible to detect BSE infectivity 1000 time more
> efficiently than
>
> before. This assay has revealed the presence of BSE infectivity in some
but
> not all
>
> peripheral nerves and in one muscle. (Buschmann and Groschup, 2005) This
> published
>
> and peer reviewed work is consistent with other publicly reported studies
in
> Japan where,
>
> by western blot testing, ,prions were found in the peripheral nerves of a
> naturally infected
>
> 94-month-old cow. We feel that the studies as reported above have merit.
The
> current
>
> studies not only re-etiorce the risk of down and deadstock but also appear
> to provide
>
> additional information that these animals may be a potential source of
> greater levels of
>
> infectivity into the feed .system. We also doubt that brain and spinal
cord
> can be
>
> completely removed especially during warmer weather. Given the biological
>
> composition of these tissues, they are predisposed to rapid autolysis.
>
> As world wide surveillance for BSE increases, several atypical cases of
> bovine TSE have
>
> been discovered. These cases either show no clinical signs, or present as
> ‘downers’, and
>
> have an atypical neuropathology with respect to lesion morphology and
> distribution,
>
> causing problems in both clinical and post-mortem diagnosis. The origin of
> the cases are
>
> unclear but they suggest that even should typical BSE be eliminated, there
> may be other
>
> TSE diseases of cattle that could result by “mutation” and selection.
> Refeeding of
>
> contaminated protein could potentially perpetuate transmission much like
> typical BSE.
>
> An effective feed ban could prevent the expansion of such strains. We also
> note that
>
> there are other species which are susceptible to BSE and the current
> regulations allow for
>
> SRMs to be included in feed for these animals.
>
> For BSE to be perpetuated, the animal production system must have a source
> of agent and
>
> a means by which cattle or other susceptible species are exposed to this
> agent. We feel
>
> that in North America, the source and routes of exposure still exist,
hence
> allowing for
>
> the continued recycling of BSE. We have detailed the scientific
> justifications for our
>
> position below.
>
> Source of the agent: SRMs (Specified Risk Materials) r
>
> SRMs, as defined by the USDA, are tissues which, in a BSE infected animal,
> are known
>
> to either harbor BSE i&:ctivity or to be closely associated with
> infectivity. If SRMs are
>
> not removed, they may introduce BSE infectivity and continue tq provide a
> source of
>
> animal feed contamination. For example, the skull and vertebral column
which
> encase
>
> the brain and spinal cord, respectively, can be assumed to have gross
> contamination.
>
> Rendering will reduce infectivity but it will not totally eliminate it.
This
> is significant as
>
> research in the United Kilngdom has shown that a calf may be infected with
> BSE by the
>
> ingestion of as little as AI01 gram of untreated brain.
>
> The tissue distribution of infectivity in BSE infected cattle has
primarily
> been determined
>
> by 3 studies conducted in the United Kingdom all of which had limitations.
>
> In two of the studies, bioassays were done in mice which are at least 1000
> fold less
>
> sensitive to BSE infection than cattle themselves. Only higher titers of
> infectivity can be
>
> detected by this method. These investigations found infectivity in the
> brain, spinal cord,
>
> retina, trigeminal ganglia, dorsal root ganglia, distal ileum and bone
> marrow (the bone
>
> marrow finding was from one animal). Infectivity was found in distal ileum
> of
>
> experimentally infected calves beginning six months after challenge and
> continuing at
>
> other intervals throughout life. (Wells et. al., 1994; 1998). The bioassay
> study in calves
>
> has produced similar results and in addition infectivity has been found in
> tonsil. The
>
> study is still in progress. Another project has found infectivity in the
> lymphoid tissue of
>
> third eyelid from naturally infected animals. (Dr. Danny Matthews, UK
DEFRA,
>
> personal communication).
>
> While bioassay in cattle is far preferable to mice in terms of
sensitivity,
> cattle
>
> nevertheless present their own limitations in terms of the long incubation
> time and the
>
> limited number of anim& that can be used for assay compared to rodents. As
a
>
> consequence the significance of the negative finding for many tissues is
> questionable. In
>
> fact, by the end of 2004 there was increasing evidence in species other
than
> cattle that
>
> peripheral nerves and muscle have infectivity. (Bosque et al., 2002;
Glatzel
> et al.,
>
> 2003;Bartz et al., 2002; Androletti et al., 2004; Mulcahy et al., 2004;
> Thomzig et al.,
>
> 2003; Thomzig et al., 2004)
>
> In some of these species, studies indicate that the agent migrates to the
> brain and spinal
>
> cord, replicates to high levels in the CNS and then spreads centrifugally
> from the spinal
>
> cord back down through the spinal neurons to the junction of the nerves
and
> muscle into
>
> the muscle cells themselves. A recent German study (Buschmann and
Groschup,
> 2005)
>
> examined nerves and muscle from a cow naturally infected with BSE and
found
> tbat
>
> infectivity was present in several peripheral nerves and one muscle. The
> method of
>
> detection was bioassay in bovinized transgenic mice that show the same or
> greater
>
> sensitivity to transmission of BSE as cattle. This research concurs with
> findings by
>
> Japanese scientists that BSE infectivity is present in peripheral nerves
at
> least in the
>
> clinical stage of disease.
>
> It is our opinion that there is increasing evidence that the pathogenesis
of
> BSE might not
>
> be entirely different from TSEs in other species at the point of clinical
> disease in that
>
> there is peripheral involvement. We feel that the studies as reported
above
> have merit.
>
> The current studies not only re-enforce the risk of down and deadstock but
> also appear to
>
> provide additional information that these animals may be a potential
source
> of greater
>
> levels of infectivity into the feed system.
>
> In the event that FDA may confer with USDA about the risks associated with
> peripheral
>
> nerves we want to point out one issue. In the recent publication of the
> final rule on the
>
> SSOI-Z6L.-ZEL
>
> importation of whole cuts OF boneless beef from Japan, 9 CFR Part 94
[Docket
> No. 05-
>
> 004-21 RIN 0579-AB93, we disagree with the interpretation provided by
USDA,
> APHIS.
>
> APHIS seems to discount the studies conducted by Groschup et al. 2005. on
> the basis that
>
> the transgenic mouse bioassay that they used may be too sensitive. In
taking
> this position
>
> they have failed to realize that the point oFan assay is to reveal in
which
> tissues the
>
> infectivity resides and its relative concentration to brain or spinal
cord.
> For this purpose,
>
> no assay can be too sensitive. Of course, the probability of an actual
> infection will he
>
> affected by the efficiency of infection which will be a function of dose,
> route of exposure
>
> and any host barrier effects that are present.
>
> We would also like to point out a factual error in the conclusion. APHIS
> states, “Given
>
> these factors, APHIS has determined that the finding of l3SE infectivity
in
> facial and sciatic nerves
>
> of the transgenic mice is nalt directly applicable to cattle naturally
> infected with BSE. Therefore,
>
> we do not consider it necessary to make any adjustments to the risk
analysis
> for this rulemaking
>
> or to extend the comment Fleriod to solicit additional public comment on
> this issue.” It is incorrect
>
> that the infectivity was found in the peripheral nerves of transgenic
mice.
> The peripheral
>
> nerves were harvested from a cow naturally infected with BSE. Transgenic
> mice were
>
> used as a bioassay model.
>
> From [Docket No. 05-004-21 RIN 0579-AB93:
>
> “Peripheral Nerves
>
> Issue: Two commenters stalted that the underlying assumption of the
proposed
> rule. that whole
>
> cuts of boneless beef from #Japan will not contain tissues that may carry
> the BSE agent, is no
>
> longer valid because researchers have found peripheral nervous system
> tissues, including facial
>
> and sciatic nerves, that contain BSE infectivity.U One of these commenters
> requested API-W to
>
> explain whether and what additional mitigation measures are needed to
reduce
> the risks that
>
> these tissues may be present in Japanese beef. This commenter further
> requested an additional
>
> comment period to obtain public comments to treat this new scientiic
> finding.
>
> \2\ Bushmann, A., and Groschup, M.; Highly Bovine Spongiform
>
> Encephalopathy-Sensitive Transgenic Mice Confirm the Essential
>
> Restriction of Infectivity to the Nervous System in Clinically
>
> Diseased Cattle. The Journal of Infectious Diseases, 192: 93442,
>
> September 1, 2005.
>
> Response: APHIS is familiar with the results of the study mentloned by the
> commenters in which
>
> mice, genetically engineered to be highly susceptible to BSE and to
> overexpress the bovine prion
>
> protein, were inoculated with tissues from a BSE-infected cow. This study
> demonstrated low
>
> levels of infectivity in the mouse assay in the facial and sciatic nerves
of
> the peripheral nervous
>
> system. APHIS has evaluated these findings in the context of the potential
> occurrence of
>
> infectivity in the peripheral nerves of cattle and the corresponding risks
> of the presence of
>
> infectivity in such tissues resulting in cattle or human exposure to the
BSE
> agent. The results
>
> from these experiments in genetically engineered mice should be
interpreted
> with caution, as the
>
> findings may be influenced by the overexpression of prion proteins and may
> not accurately
>
> predict the natural distribution of BSE infectivity in cattle. Further,
the
> overexpression of priori
>
> s-d
>
> proteins in transgenic mice may not accurately mimic the natural disease
> process because the
>
> transgenic overexpressing mice have been shown to develop spontaneous
lethal
> neurological
>
> disease involving spongifolrm changes in the brain and muscle
> degeneration.\3\ In addition, the
>
> route of administration to the mice was both intraperitoneal and
> intracerebral, which are two very
>
> efficient routes of infection as compared to oral consumption. Given these
> factors, APHIS has
>
> determined that the finding of BSE infectivity in facial and sciatic
nerves
> of the transgenic mice is
>
> not directly applicable to cattle naturally infected with BSE. Therefore,
we
> do not consider it
>
> necessary to make any adjustments to the risk analysis for this rulemaking
> or to extend the
>
> comment period to solicit additional public comment on this issue.”
>
> Source of the agent: Deaalstock
>
> The total amount of TSE infectivity in a TSE infected animal increases
> steadily
>
> throughout the infection and exponentially once the infectivity reaches
the
> brain.
>
> Infected individuals only exhibit recognizable clinical signs once
> infectivity titers have
>
> reached high levels in the brain. Surveillance data collected throughout
> Europe indicates
>
> there is a much greater likelihood for BSE to be detected in dead or down
> cattle than
>
> from healthy normal animals. This has so far also been borne out by the
> experience in
>
> North America. Animals that die of BSE harbor the greatest amount of agent
> that can be
>
> produced by the disease. Leaving the tissues from the highest risk
category
> of cattle in
>
> the animal feed chain will effectively nullify the purported intent of
this
> regulation. This
>
> point is supported by the 2001 Harvard risk assessment model that
> demonstrated that
>
> eliminating dead and downer, 4D cattle, from the feed stream was a
> disproportionately
>
> effective means of reducing the risk of re-infection.
>
> “The disposition of cattle thot die on the farm would also huve a
> substantial influence on
>
> the spread of BSE if the disease were introduced ” The base case scenario
> showed that
>
> the mean rota? number oj’IDS0.s (i.e., dosage suficient to infecf
50percent
> of exposed
>
> cattle) f;om healthy animals at slaughter presented to the foodfeed system
> was 1500.
>
> The mean total number yf IDSOsfiom adult cuttle deadstockpresented fo the
> feed system
>
> was 3 7,000. This illustrates the risk of “40 cattle ” (i.e.. deadstock).
>
> From the Harvard Risk Assessment, 200 1, Appendix 3A Base Case and Harvard
> Risk
>
> Assessment, 200 1 Executive Summary
>
> It is likely that these numbers would have to be adjusted upwards, if the
UK
> attack rate
>
> and Groschup data were considered.
>
> Inflammation and TSErr
>
> There have been 3 recent peer reviewed publications which indicate that
> chronic
>
> ir&unmatory conditions in a host with a TSE may induce priori replication
> in, or
>
> distribution to organs previously thought to be low or no risk. They are
as
> follows:
>
> s-d
>
> 1 _ Chronic Lymphocytic Inflammation Specifies the Organ Tropism of Prions
>
> (Heikenwalder et. al. 2005 >~xx .sci~:n~c\rpl-css.~~r~/~O .lunuarv 2005/
> Parrc l/
>
> &).I 1zois~icllcc.l lOh4hO)
>
> 2. Coincident Scrapie Infection and Nephritis Lead to Urinary Priori
> Excretion
>
> (Seeger et al., Science 14 October 2005:Vol. 310. no. 5746, pp. 324 - 326
>
> DOI: lO.l126/science. 1118829)
>
> 3. PrPS” in mammary glands of sheep affected by scrapie and mastitis
(Ligios
> C., et
>
> al. Nature Medicine, 11. 3 137 - 1138, 2005)
>
> These studies from the Aguzzi laboratory warn that concurrent chronic
> inflammatory
>
> disease could dramatically alter the distribution of BSE infectivity in
> infected cattle.
>
> Down and dead stock are at higher risk for both BSE and other systemic
> conditions. If
>
> the results reported above are also applicable to cattle, the carcasses of
> dead and down
>
> stock affected by BSE might contain even higher levels of infectivity, or
> contribute
>
> infectivity via tissues thai. are not ordinarily at risk in normal
animals.
>
> Exposure: tndustry Practices or Exemptions which may pose a risk
>
> Poultry Litter
>
> In the United States poultry litter can be fed to cattle. There are two
> potential sources of
>
> risk from poultry litter. Poultry litter not only consists of digested
feed
> but also of feed
>
> which spills from the cages. As a consequence, the practice of feeding
> litter back to
>
> cattle is by its nature non--compliant with the current feed ban if the
> poultry themselves
>
> are being fed ruminant protein. Given that ruminant protein can no longer
be
> fed to
>
> ruminants in the United States and that most. if not all. countries will
no
> longer import
>
> North American ruminant MBM, an even larger part of poultry diets is now
> ruminant
>
> MBM. Spillage provides a direct link to back to cattle but feces are also
> likely to contain
>
> infectivity.
>
> There is no reason to expect that TSE infectivity would be inactivated by
> passage through
>
> the poultry gut, and only a slim possibility that composting would reduce
> infectivity at
>
> all. Thus poultry feces are another potential route of transmission back
to
> cattle.
>
> Evidence for this comes from rodent experiments where infectivity was
> demonstrated in
>
> the feces after being fed: “Laboratory experiments show that mice orally
> challenged with
>
> scrapie have detectable infectivity that passes through the gut. Gut
> contents and fecal
>
> matter may therefore contain infectivity, and it is noted that in
> experimental oral
>
> challenges in cattle conducted in the UK, feces must be treated asamedical
> waste for one
>
> month following the challenge. It is concluded that digestive contents and
> fecal material
>
> from livestock or poultry currently being fed with MBM potentially
> contaminated with
>
> BSE should not be used a.s a feed ingredient for animal feed.”
[Proceedings:
> Joint
>
> WHO/FAO/OIE/ Technical Consultation on BSE: public health, animal health
and
>
> trade. Paris, lo-14 June 2001; and Alan Dickinson, personal
communication].
>
> It may be possible to remove the risk from poultry litter by
sterilization.
> However, unless
>
> or until a method can be developed and validated, poultry litter should be
> banned from
>
> ruminant feed.
>
> Ruminant Blood
>
> In contrast with humans, sheep, monkeys, mice and hamsters, including
sheep
> and mice
>
> infected with BSE and humans infected with vCJD considered identical to
BSE,
> no
>
> infectivity has so far been demonstrated in the blood of BSE infected
> cattle. However,
>
> we consider it unlikely that cattle are the sole outlier to what has been
a
> consistent finding
>
> in all other TSE diseases where the measurement has been made with
> sufficient
>
> sensitivity to detect the low levels of infectivity that are present in
> blood. Rather, this
>
> failure is more likely the result of the very small volumes of blood that
> were used for the
>
> inoculations (less than 1 ml), whereas whole transfusions were
administered
> to assay
>
> animals in the published .sheep scrapie/BSE experiments. If blood is
> infected then all
>
> vascularized tissues can bc expected to contain some infectivity in
> proportion to the
>
> content of residual blood..
>
> Micro emboli are a possible source of blood-borne agent that could be at
> much higher
>
> titer than blood itself, in slaughtered cattle carrying BSE infection.
> Stunning can release
>
> micro emboli of brain tissue into the circulatory system from where they
can
> be
>
> distributed to other tissues in the few moments before the exsanguination
> and
>
> death. (Anil, et al, 2001a & b; Anil et al, 2002; Love, et al, 2000). This
> source of
>
> infection couid extend a higher infectivity risk to tissues that would
> otherwise be at low
>
> risk, thereby allowing exposure of cattle through any of the legal
> exemptions and
>
> potentially producing a feed and food risk. Blood-borne contamination may
be
> a special
>
> problem where spray-dried blood is being used as a milk replacer for
calves,
> as it is
>
> thought that young animals are especially susceptible to infection.
>
> Certainly, blood and bloald proteins should not be used as feed without
> conclusive
>
> evidence that they are saf’e.
>
> Unfiltered Tallow
>
> Ruminant tallow is exempted from the current feed ban. Tallow contains
> protein
>
> impurities (i.e. MBM) that could be a source of TSE infectivity. There are
> no impurity
>
> level requirements for this tallow. It has been reported that it is
standard
> practice to
>
> produce tallow which has an impurity level of _ 15% or below, but it is
not
> clear that this
>
> is fully adequate to remove the risk of transmission and there is no
> requirement to meet
>
> even this standard. We urge that protein contaminants be excluded from
> tallow and that
>
> SRMs also be removed.
>
> 6-d
>
> Plate Waste
>
> Plate waste is not limiteld to meat (muscle tissue). For example, cuts
that
> include a
>
> portion of the spinal cor’d or that are contaminated by cord or ganglia
> during preparation
>
> could contain high levels of infectivity if derived from a TSE infected
> animal late in the
>
> preclinical stage of infection. At best this material would only be
exposed
> to normal
>
> cooking temperatures. USDA, APHIS experience with the Swine Health
> Protection Act
>
> has revealed that plate waste also includes uncooked trimmings and bones.
> Although the
>
> current FDA regulation requires the plate waste be treated again, there
are
> no
>
> specifications which would render a TSE agent inactive. Of greatest risk
> would be any
>
> bovine source of infectivity but also sheep scrapie, although not known to
> be a risk for
>
> human consumption, is one of the possible origins of BSE. The sheep
scrapie
> agent is
>
> known to be widely dispersed including relatively high titers in lymphoid
as
> well as
>
> nervous tissue. We support the USDA’s opposition to the exemption of
“plate
> waste” as
>
> stated in written comments since 1997.
>
> Exposure: Cross Feeding and Cross Contamination
>
> The UK epidemiology has clearly shown that BSE contaminated feed is the
> primary if
>
> not sole vehicle for the transmission of BSE between cattle. Moreover,
> results from the
>
> United Kingdom’s attack: rate study indicate that it does not take much
> exposure to
>
> transmit BSE to cattle. FLecent results from the attack rate study which
is
> still in progress
>
> have found that _ 1 g of brain transmitted BSE by the oral route to 3 cows
> out of 15 thus
>
> far, and .Ol and .OOl gr of brain have transmitted BSE (1 cow out of 15).
> (Danny
>
> Matthews, DEFRA presentation at TAFS meeting, Washington, DC April 2004).
>
> Rendering may reduce infectivity but it does not eliminate it. (Taylor et
> al, 1995; Taylor
>
> et al, 1997; Schreuder et al, 1998). Given that BSE can be transmitted to
> cattle via an
>
> oral route with just .OO 1 gram of infected tissue, it may not take much
> infectivity to
>
> contaminate feed and kee:p the disease recycling. This is especially true
in
> countries like
>
> the US and Canada which do not have dedicated lines and equipment to
> manufacture and
>
> process feed for ruminants and non-ruminants.
>
> In addition, epidemiological investigations in European countries have
shown
> that cross
>
> feeding and cross contamination on farm can be a significant vehicle for
> continued BSE
>
> transmission even after feed bans are well established. Cross feeding is
the
> practice of
>
> feeding meal for poultry or pigs or pet food (which can legally contain
> ruminant MBM)
>
> to cattle on the same farm. This is usually due to simple human error or
> negligence.
>
> (Hoinville, 1994; Hoinville et al, 1995; Doherr et al, 2002% Stevenson et
> al, 2000)
>
> FDA, CVM reports that compliance with the existing feed ban is high. For
the
> most part
>
> this does not include the compliance level on the farm. There are hundreds
> of thousands
>
> of farms in the US. Many of these have multiple species- That is, they
raise
> cattle, pigs,
>
> chickens etc., on the same premises. The sheer numbers of farms make it
very
> difficult to
>
> assure compliance on farm and to adequately cover all farms by inspection-
> Even if the
>
> rendering industry and feed industry can maintain 100% compliance at their
> facilities, if a
>
> producer inadvertently feeds chicken feed containing bovine MBM to their
> cattle, they
>
> negate a perfect compliance rate higher in the chain. Recent data from the
> Harvard BSE
>
> risk assessment suggest that the level of misfeeding on farms plays a
> significant role in
>
> the ability of the agent to recycle. In fact George Gray, principal
> investigator for the
>
> study, stated that if, in the United States, misfeeding were to occur at a
> level of 15%, the
>
> RO would be over 1, indicating that the BSE level would not be declining.
> (George Gray
>
> presentation at the Meeting on BSE Prevention in North America: An
Analysis
> of the
>
> Science and Risk; January 27,2005, Washington, DC.)
>
> The May 2003 Canadian BSE case illustrates the difficulty of on farm
> enforcement and
>
> its serious ramifications. The BSE positive cow was rendered and the MBM
> distributed
>
> to various locations. Two of these locations were poultry farms which
mixed
> their own
>
> feed. The farms also had cattle. The subsequent investigation could not
> eliminate the
>
> possibility that the cattle had been fed the same feed as the poultry. The
> cattle on these
>
> farms were completely depopulated.
>
> Human error is extremel:y difftcult to prevent, and managing the risk
> through
>
> enforcement is problematical when confronted with the extreme logistical
> challenges of
>
> on farm monitoring. By eliminating the highest risk materials (SRMs and
> deadstock)
>
> which could introduce infectivity into the feed stream, the MBM resulting
> from
>
> processing becomes inherently safer. If mistakes are then made on farm,
they
> no longer
>
> contribute to the recycling of BSE.
>
> Exposure: Susceptibility of other Species
>
> Felines
>
> A transmissible spongifoim encephalopathy has been diagnosed in eight
> species of
>
> captive wild ruminants as well as exotic felines (cheetahs, pumas, a tiger
> and an ocelot)
>
> and domestic cats (Wyatt 1991). There have been over 80 domestic cat cases
> of Feline
>
> Spongiform Encephalopathy (FSE) in Great Britain, and cats in Norway,
> Northern
>
> Ireland, Lichtenstein and Switzerland. The agent isolated from several of
> these cases is
>
> indistinguishable from BSE in cattle using strain typing in mice,
duggesting
> that FSE is
>
> actually BSE in exotic and domestic cats. Epidemiological evidence
suggests
> BSE
>
> contaminated feed to be the probable source of infection in these species.
> (MAFF
>
> Progress Report, June 1997), thus providing additional supporting evidence
> for the
>
> dangers of BSE contaminated feed and reinforcing the necessity of removing
> all sources
>
> of potential contamination from the feed stream
>
> Other species
>
> Studies conducted at the National lnstitutes of Health Rocky Mountain
> Laboratory
>
> caution against assuming that animals which do not become clinically ill
are
> not infected.
>
> It is unknown if certain animals may become carriers, i.e., become
infected,
> shed agent
>
> but do not progress to clinical disease. Infection of certain rodent
species
> with different
>
> TSE strains suggests the possibility of a carrier state (Race and
Chesebro,
> 1998; Race et.
>
> al, 2001, Race et al., 2002). In the more recent studies, mice were
> inoculated with 263K
>
> hamster scrapie. There was a prolonged period (approximately one year)
where
> there was
>
> no evidence of replication of infectivity. Furthermore, there was no
> evidence of PrPres
>
> during this phase of inactive persistence, which was followed by a period
of
> active
>
> replication of infectivity and agent adaptation. In most cases, PrPres was
> not detected in
>
> the active phase as well. It is important to determine if this persistence
> and adaptation
>
> occurs in other species exposed to TSEs as it may have significance in
> feeding programs
>
> which continually expose other species to BSE infectivity. For example, if
> BSE infected
>
> brain and spinal cord are continually fed to certain species, it may be
> possible for the
>
> agent to persist and adapt in these new species. Over time, the ‘resistant
’
> species may
>
> become a source of agenl. The results of Race and colleagues, warns that
an
> inactive
>
> persistent phase might not produce detectable PrPres, yet there would be
> infectivity (Race
>
> et. al., 2001).
>
> Pigs displayed evidence of TSE infection after exposure to BSE by 3
distinct
> parer&ml
>
> routes. Evidence of infectivity was found in the CNS, stomach, intestine
and
> pancreas
>
> (Dawson et. al., 1990). CIral transmission has also been attempted in
swine,
> but after an
>
> observation period of 84 months there was neither clinical nor
pathological
> evidence of
>
> infection (Dawson et. al., 1990). Parenteral and oral transmission has
also
> been
>
> attempted in chickens with no evidence of disease. Tissues from the
> BSE-challenged
>
> pigs and chickens were inoculated into susceptible mice to look for
residual
> infectivity,
>
> but to date none has been found. In both instances the detection
sensitivity
> was limited
>
> by the use of mice for bioassay instead of same species transmissions into
> cattle (or pigs
>
> and chickens).
>
> If any of these scenarios played out and inapparent infections became
> established in
>
> commercial species, those species could become reservoirs for reinfection
of
> cattle and
>
> perpetuation or reintroduction of the epidemic. We also do not know if
> atypical cases of
>
> BSE are more pathogenic for other species and if chronic inflammation may
> influence the
>
> susceptibility of other species. We offer these possibilities to reitiorce

> the need to
>
> eliminate all possible sources of infectivity from the feed stream.
>
> In January 2005, the European Union announced that BSE had been confirmed
in
> a goat
>
> in France illustrating that the disease can be naturally transmitted to
one
> of the small
>
> ruminants. The potential ramifications of this and the logistical
chaIlenges
> associated
>
> with controlling BSE in sheep or goats also provides a justification for
> removing SRMs
>
> from all animal feed. Although these species are covered under the current
> regulations
>
> the cross contamination and cross feeding aspects stated for cattle are
> applicable.
>
> The need to remove high risk material from all animal feed is also
supported
> by other
>
> bodies with expertise in the field of TSEs:
>
> Recommendations of the World Health Organization (WHO)
>
> The World Health Organization (WHO) has issued the following
recommendations
> for
>
> countries with BSE or those where a known exposure exists:
>
> l No part or product of any animal which has shown signs of a TSE should
> enter any
>
> food chain (human or animal). In particular:
>
> o All countries must ensure the killing and safe disposal of all parts or
> products
>
> of such animals so that TSE infectivity cannot enter any food chain.
>
> o Countries sholuld not permit tissues that are likely to contain the BSE
> agent to
>
> enter any food chain (human or animal).
>
> From the report of a WHO Consultation on Public Health Issues related to
> Human and
>
> Animal Transmissible Spongiform Encephalopathies WHO/EMC/DIS 96.147,
Geneva,
>
> 2-3 April 1996.
>
> Office of International El-
>
> The OIE is recommendinlg that a list of SRMs which include brain, spinal
> cord, eyes,
>
> skull and vertebral column be removed from preparations used for food,
feed,
> fertilizer,
>
> etc. If these tissues sholtld not be traded we feel that they should not
be
> used in domestic
>
> products either.
>
> BSE Code Article 2.3.13.18
>
> “From cattle, originating from a country or zone with a minimal BSE risk,
> that were at the time of
>
> slaughter over 30 months of age, the following commodities, and any
> commodity contaminated by them,
>
> should not be traded for the preparation of Food, feed, fertilizers,
> cosmetics, pharmaceuticals including
>
> biologicals, or medical device:s: brains, eyes and spinal cord, skull,
> vertebral column and derived protein
>
> products. Food, feed, fertilizers, cosmetics, pharmaceuticals or medical
> devices prepared using these
>
> commodities should also not be traded.”
>
> Conclusion
>
> In conclusion we urge the: FDA to implement, monitor and enforce a
> comprehensive and
>
> protective feed ban that is more congruent with the measures that have
been
> proven to be
>
> effective in other countries that have experienced BSE. We do not feel
that
> we can
>
> overstate the dangers from the insidious threat from these diseases and
the
> need to control
>
> and arrest them to prevent any possibility of spread.
>
> We also wish to emphasize that as scientists who have dedicated
substantive
> portions of
>
> our careers to defining the risks from TSEs as well as developing
strategies
> for managing
>
> those risks, we are confident that technical solutions will be found for
> many of the
>
> challenges posed by these diseases. Thus, we urge the FDA to frame its
> regulations in
>
> terms that allow for the future use of any banned material if it can be
> proven safe for a
>
> given application.
>
> El-d
>
> Signatories:
>
> Paul W. Brown, M.D.
>
> Medical Director, USPH[S, and Senior Investigator, NIH (retired)
>
> Consultant, TSE Risk Management
>
> 78 15 Exeter Rd.
>
> Bethesda, MD 208 14
>
> Fax 301-652-43 12
>
> Email: paLII\\ hr-c~~~rl~~/‘~c)m~as~.rlct -----
>
> Neil R Cashman MD
>
> Professor, Department 0-C Medicine (Neurology)
>
> Diener Chair of Neurode:generaGve Diseases
>
> Centre for Research in Neurodegenerative Diseases
>
> 6 Queen’s Park Crescent West
>
> Toronto Ontario M5S3H2
>
> Ph: 416-978-1875
>
> Fax: 4 16-978- 1878
>
> e-mail: neil.cashman@utoronto.ca
>
> Linda A. Detwiler, DVM
>
> Consultant, TSE Risk Management
>
> 225 Hwy 35
>
> Red Bank, NJ 07701
>
> Ph 732-74 l-2290
>
> Fax 732-741-775 1
>
> Email: l.~\Vc~92’rr’ac,l.c0111.
>
> Laura Manuelidis, MD
>
> Professor and Head of Neuropathology,
>
> Department of Surgery and Faculty of Neurosciences
>
> Yale Medical School
>
> 333 Cedar St.
>
> New Haven, CT 065 10
>
> email: I~IL~ra.~~~ar~clclirli~~~~~~alc.cdi~
>
> Tel: 203-785-4442
>
> Jason C. Bar-k, Ph.D.
>
> Assistant Professor
>
> Department of Medical Microbiology and Immunology
>
> Creighton University
>
> 2500 California Plaza
>
> Omaha, NE 68178
>
> (402) 280- 18 11 voice
>
> (402) 280-l 875 fax
>
> jbartz@creighton .edu
>
> Robert B. Petersen, Ph.D.
>
> Associate Professor of Pathology and Neuroscience
>
> Case Western Reserve University
>
> 5- 123 Wolstein 13~1ilding
>
> 2 103 Cornell Road
>
> Cleveland, OH 44 106-26122
>
> Phone 216-368-6709
>
> FAX 360-838-9226
>
> Email rhp~,-c\\~~.c~!t~
>
> Robert G. Rohwer, Ph.D.
>
> Director, Molecular Neurovirology Laboratory
>
> Veterans Affairs Medicall Center
>
> Medical Research Service 151
>
> Assoc. Professor of Neurology
>
> School of Medicine
>
> University of Maryland ;at Baltimore
>
> 10 N. Greene St.
>
> Baltimore, MD 21201
>
> ph. 4 1 O-605-7000 x6462
>
> Fax 4 1 o-605-7959
>
> email: rrohwer@maryland.edu
>
> REFERENCES
>
> Andreoletti 0, Simon S, Lacroux C, Morel N, Tabouret G, Chabert A, Lugan
S,
> Corbiere
>
> F, Ferre P, Fouc,ras G, Laude H, Eychenne F, Grassi J, Schelcher F. PrPSc
> accumulation
>
> in myocytes from sheep incubating natural scrapie. Nat Med. 2004
> Jun;10(6):591-3.
>
> Epub 2004 May 23.
>
> Ani1,M.H.; Love,S.; Hr:lps,C.R.; McKinstry.J.L.; Brown,S.N.; Philips,A.;
> Williams,S.;
>
> Shand,A.; Baki.rel,T.; Harbour,D.A. - Jugular venous emboli of brain
tissue
> induced in
>
> sheep by the use of captive bolt guns - Veterinary Record 2001 May 19;
148:
> 619-20
>
> Ani1,M.H.; Harbour,D.A. - Current stunnin g and slaughter methods in
cattle
> and sheep.
>
> Potential for carcass contamination with central nervous tissue and
> microorganisms -
>
> Fleischwirtschaft 200 1; 11: 123
>
> Ani1,M.H.; Love& He:lps,C.R.; Harbour,D. - Potential for carcass
> contamination with
>
> brain tissue following stunning and slaughter in cattle and sheep - Food
> Control 2002; 13:
>
> 431-6
>
> Bartz JC, Kincaid AE, IBessen RA. Retrograde transport of transmissible
mink
>
> encephalopathy within (descending motor tracts. J Virol. 2002
> Jun;76(11):5759-68.
>
> Bosque PJ, Ryou C, Telling G, Peretz D, Legname G, DeArmond SJ, Prusiner
SB.
>
> Prions in skeletal muscle. Proc Nat1 Acad Sci U S A. 2002 Mar
> 19;99(6):3812-7.
>
> Bushmann, A., and Groschup, M.; Highly Bovine Spongiform
> Encephalopathy-Sensitive
>
> Transgenic Mice Confilm the Essential Restriction of Infectivity to the
> Nervous System
>
> in Clinically Diseased Cattle. The Journal of Infectious Diseases, 192:
> 934-42, September
>
> 1,2005.
>
> Dawson,M.; Wells,G.A.H.; Parker,B.N.; Scott,A.C. - Primary parenteral
> transmission of
>
> bovine spongiform encephalopathy to the pig - Veterinary Record 1990 Sep
29;
> 127( 13):
>
> 338
>
> Doherr,M.G.; Hett,A.R.; Rufenacht,J.; Zurbriggen,A.; Heim,D. -
Geographical
> clustering
>
> of cases of bovine spongiform encephalopathy (BSE) born in Switzerland
after
> the feed
>
> ban - Veterinary Record 2002 Ott 19; 15 1(16): 467-72
>
> Glatzel M, Abela E, Ma.issen M, Aguzzi A. Extraneural pathologic prion
> protein in
>
> sporadic Creutzfeldt-Jakob disease. N Engl J Med. 2003 Nov 6;349(19):
> 1812-20.
>
> Hadlow W. J., Kennedy R. C. & Race R. E. (1982) Natural infection of
Suffolk
> sheep
>
> with Scrapie virus. J. hfect. Dis., 146, 657-664
>
> Hoinville,L.J. - Decline in the incidence of BSE in cattle born after the
> introduction of the
>
> ‘feed ban’ - Veterinary IRecord 1994 Mar 12; 134( 11): 274-5
>
> Hoinville,L.J.; Wi1esmithJ.W.; Richards,M.S. - An investigation of risk
> factors for cases
>
> of bovine spongiform encephalopathy born after the introduction of the
‘feed
> ban’ -
>
> Veterinary Record 199.5 Apr 1; 136( 13): 3 12-8
>
> Houston,E.F.; Foster,J.D.; Chong,A.; Hunter,N.; Bostock,C.J. -
Transmission
> of BSE by
>
> blood transfusion in sheep - Lancet 2000 Sep 16; 356(9234); 999-l 000
>
> Hunter,N.; Foster,J; Chong,A.; McCutcheon,S.; Parnham,D.; Eaton,S.;
> MacKenzie,C.;
>
> Houston,E.F. - Transmission of prion diseases by blood transfusion -
Journal
> of General
>
> Virology 2002 ‘Nov, 83(Pt 11); 2897-905.
>
> Love,S.; Helps,C.R.; Williams,S.; Shand,A.; McKinstry,J.L.; Brown,S,N.;
> Harbour,D.A.;
>
> Ani1,M.H. - Methods for detection of haematogenous dissemination of brain
> tissue after
>
> stunning of cattle with captive bolt guns - Journal of Neuroscience
Methods
> 2000 Jun 30;
>
> 99( l-2): 53-8
>
> Mukahy ER, Bar-& JC, Kincaid AE, Bessen RA. Priori infection of skeletal
> muscle cells
>
> and papillae in the tongue. .J Viral. 2004 Jul;78(13):6792-8.
>
> Race, R.; Chesebro, B. - Scrapie infectivity found in resistant species.
> Nature -1998 Apr
>
> 23;392(6678):770.
>
> Aguzzi,A.; Weissmann,C. - Spongiform encephalopathies. The priori’s
> perplexing
>
> persistence. - Nature. 1998 Apr 23;392(6678):763-4
>
> Race,R.E.; Raines,A.; Raymond,G.J.; Caughey,B. W.; Chesebro,B. - Long-term
>
> subclinical carrier state precedes scrapie replication and adaptation in a
> resistant species:
>
> analogies to bovine spongiform encephalopathy and variant
Creutzfeldt-Jakob
> disease in
>
> humans. - Journal of V:irology 2001 Nov; 75(2 1): 10106-l 2
>
> Race,R.E.; Meade-White&; Raines,A.; Raymond,G.J.; Caughey,B.W.;
> Chesebro,B. -
>
> Subclinical Scrapie Infkction in a Resistant Species: Persistence,
> Replication, and
>
> Adaptation of Infectivity during Four Passages. - Journal of Infectious
> Diseases 2002 Dee
>
> 1; 186 Suppl2: S166-70
>
> Schreuder, B.E.C., Geertsma, R.E., van Keulen, L.J.M., van Asten,
J.A.A.M.,
> Enthoven, P.,
>
> Oberthiir, R.C., de Koeijer, A.A., Osterhaus, A.D.M.E., 1998. Studies on
the
> effkacy of
>
> hyperbaric rendering procedures in inactivating bovine spongiform
> encephalopathy (BSE) and
>
> scrapie agents. Veterinary Record I42,474-480
>
> Stevenson, M. A., Wilesmith, J. W., Ryan, J. B. M., Morris, R.S.,
Lockhart,
> J. W., Lin,
>
> D. & Jackson, R. (2000) Temporal aspects of bovine spongiform
encepalopathy
> in Great
>
> Britain: individual animal-associated risk factors for the disease. Vet.
> Rec. 147, 349-354.
>
> Stevenson, M. A., Wilesmith, J. W., Ryan, J. B. M., Morris, R. S., Lawson,
> A.B.,
>
> Pfeiffer, D. U. & Lin, D. (2000) Descriptive spatial analysis of the
> epidemic of bovine
>
> spongiform encephalopalthy in Great Britain to June 1997. Vet. Rec.
> 147,379-384.
>
> Taylor, D.M., Woodgate, !S.L., Atkinson, M.J., 1995. Inactivation of the
> bovine spongiform
>
> encephalopathy agent by rendering procedures. Veterinary Record, Vol.1 37:
> pp.605-610.
>
> Taylor, D.M., Woodgate, S-L., Fleetwood, A.J., Cawthome, R.J.G., 1997. The
> effect of rendering
>
> procedures on scrapie agent. Veterinary Record, Vol. 141, pp 643-649.
>
> Thornzig A, Schulz-Schaeffer W, KratzeI C, Mai J, Beekes M. Preclinical
> deposition of
>
> pathological prion protein PrPSc in muscles of hamsters orally exposed to
> scrapie.
>
> J Clin Invest. 2004 May; 113( 10): 1465-72.
>
> Thomzig A, Kratzel C, Lenz G, Kruger D, Beekes M. Widespread PrPSc
> accumulation
>
> in muscles of hamsters orally infected with scrapie. EMBO Rep. 2003
> IUay;4(5):530-3.
>
> Wilesmitb, J.W., Ryan, J. B. M., Hueston, W. D., & Hoinville, L. J. (1992)
> Bovine
>
> spongifozm encephalopathy: epidemiological features 1985 to 1990. Vet.
Rec.,
> 130,90-
>
> 94.
>
> Wilesmith, J. W., Wells, G. A. H., Ryan, J. B. M., Gavier-Widen, D., &
> Simmons, M. M.
>
> (1997) A cohort study to examine maternally associated risk factors for
> bovine
>
> spongiform encephalopathy. vet. Rec., 141,239-243.
>
> Wells G.A.H., Dawson h/Z., Hawkins, S-A-C., Green R. B., Dexter I.,
Francis
> M. E.,
>
> Simmons M. M., Austin A. R., & Horigan M. W. (1994) Infectivity in the
ileum
> of
>
> cattle challenged orally with bovine spongiform encephalopathy. Vet. Rec.,
> 135,40-41.
>
> Wells G.A.H., Hawkins, S.A.C., Green R. B., Austin A. R., Dexter I.,
> Spencer, Y. I-,
>
> Chaplin, M. J., Stack, M. J., & Dawson, M. (1998) Preliminary observations
> on tbe
>
> pathogenesis of experimental bovine spongiform encephalopathy (BSE): an
> update. Vet.
>
> Rec., 142, 103-106.
>
> Wyatt. J. M. et al. 1991. INaturally occurring scrap&like spongiform
> encephalopathy in
>
> five domestic cats. Veterinary Record. 129. 233.
>
>
>
>
>
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000490-vol40.pdf
>
>
>
>
>
>
>
> December 19, 2005
>
> Division of Dockets Management (HFA-305)
>
> Food and Drug Administration
>
> 5630 Fishers Lane
>
> Room 1061
>
> Rockville, MD 20852
>
> Re: Docket No: 2002N-0273 (formerly Docket No. 02N-0273)
>
> Substances Prohibited From Use in Animal Food and Feed
>
> Dear Sir or Madame:
>
> The McDonald’s Corporation buys more beef than any other restaurant in the
> United States. It is
>
> essential for our customers and our company that the beef has the highest
> level of safety.
>
> Concerning BSE, the most effective way to insure this is to create a
system
> that processes cattle
>
> that are not exposed to the disease. As a company we take numerous
> precautions via our strict
>
> specifications to help and assure this, however we feel that the force of
> federal regulation is
>
> important to ensure that the risk of exposure in the entire production
> system is reduced to as
>
> close to zero as possible. The exemptions in the current ban as well as in
> the newly proposed rule
>
> make this difficult if not impossible, as there are still legal avenues
for
> ruminants to consume
>
> potentially contaminated ruminant protein. In addition, the USDA still has
> not implemented a
>
> system of identification and traceability. It is our opinion that the
> government can take further
>
> action to reduce this risk and appreciate the opportunity to submit
comments
> to this very
>
> important proposed rule.
>
> After the identification of bovine spongiform encephalopathy (BSE) in
> indigenous North
>
> American cattle, the U.S. Department of Agriculture (USDA) responded
rapidly
> to implement
>
> measures to protect public health in regard to food. Our company
recognizes
> and supports the
>
> importance of the current feed ban which went into effect in August 1997.
> However, given what
>
> is known about the epidemiology and characteristically long incubation
> period of BSE, we urge
>
> the FDA to act without further delay and implement additional measures
which
> will reduce the
>
> risk of BSE recycling in the US cattle herd. We caution against using the
18
> month enhanced
>
> surveillance as a justification to relax or impede further actions. While
> this surveillance
>
> indicates an epidemic is not underway, it does not clear the US cattle
herd
> from infection. The
>
> positive cases indicate probable exposure prior to the 1997 feed ban, a
time
> when BSE appears to
>
> have been circulating in animal feed. BSE cases are most likely clustered
in
> time and location,
>
> so while enhanced surveillance provides an 18 month snapshot, it does not
> negate the fact that
>
> US and Canadian cattle were exposed to BSE and that the current feed
> controls contain “leaks”.
>
> We feel that for the FDA to provide a more comprehensive and protective
feed
> ban, specified
>
> risk materials (SRMs) and deadstock must be removed from all animal feed
and
> that legal
>
> exemptions which allow ruminant protein to be fed back to ruminants (with
> the exception of
>
> milk) should be discontinued.
>
> SRMs, as defined by the USDA, are tissues which, in a BSE infected animal,
> are known to either
>
> harbor BSE infectivity or to be closely associated with infectivity. If
SRMs
> are not removed,
>
> they may introduce BSE infectivity and continue to provide a source of
> animal feed
>
> contamination. Rendering will reduce infectivity but it will not totally
> eliminate it. This is
>
> significant, as research in the United Kingdom has shown that a calf may
be
> infected with BSE
>
> by the ingestion of as little as .001 gram of untreated brain.
>
> The current proposed rule falls short of this and would still leave a
> potential source of infectivity
>
> in the system. In fact by the FDA’s own statement the exempted tissues
which
> are known to
>
> have infectivity (such as distal ileum, DRGs, etc) would cumulatively
amount
> to approximately
>
> 10% of the infectivity in an infected animal. Leaving approximately 10% of
> the infectious
>
> tissues in the system is not good enough. The proposed rule still allows
the
> possibility for cattle
>
> to be exposed to BSE through:
>
> 1. Feeding of materials currently subject to legal exemptions from the ban
> (e.g., poultry
>
> litter, plate waste)
>
> 2. Cross feeding (the feeding of non-ruminant rations to ruminants) on
> farms; and
>
> 3. Cross contamination of ruminant and non-ruminant feed
>
> We are most concerned that the FDA has chosen to include a provision that
> would allow tissues
>
> from deadstock into the feed chain. We do not support the provision to
allow
> the removal of
>
> brain and spinal cord from down and deadstock over 30 months of age for
> several reasons.
>
> These are the animals with the highest level of infectivity in tissues
which
> include more than
>
> brain and spinal cord. Firstly, there are two issues regarding the complex
> logistics of this option.
>
> We do not feel that it is possible to have adequate removal especially
> during the warmer months.
>
> In addition, we do not feel that there are adequate means to enforce
> complete removal. Unlike
>
> slaughterhouses, there are no government inspectors at rendering plants or
> deadstock collection
>
> points.
>
> Most importantly, there is emerging information that at end stage disease
(a
> natural BSE case);
>
> infectivity may also be included in additional tissues such as peripheral
> nerves (Buschmann and
>
> Groschup, 2005 – see attached). This published work supports publicly
> reported studies in Japan
>
> where by western blot testing, prions have been found in the peripheral
> nerves of a naturally
>
> infected 94-month-old cow. If this is the case, the amount of infectivity
> left in the system from
>
> an infected bovine would surpass 10% and the full extent is still unknown.
>
> McDonald’s has convened it own International Scientific Advisory Committee
> (ISAC) as well as
>
> co-sponsored a symposium of TSE scientists on the issue of tissue
> distribution. The consensus
>
> of both groups was that the pathogenesis of BSE might not be entirely
> different from TSEs in
>
> other species at the point where the animal is showing signs of the
disease.
> These scientists feel
>
> that the studies as reported above have merit. The current studies not
only
> re-enforce the risk of
>
> down and deadstock but also appear to provide additional information that
> these animals may be
>
> a potential source of greater levels of infectivity into the feed system.
> Hence, we suggest that the
>
> FDA consult with TSE scientists as well.
>
> Leaving the tissues from the highest risk category of cattle in the animal
> feed chain will
>
> effectively nullify the intent of this regulation. This point is
illustrated
> by the 2001 Harvard risk
>
> assessment model that demonstrated that eliminating dead and downer, 4D
> cattle, from the feed
>
> stream was a disproportionately effective means of reducing the risk of
> re-infection.
>
> “The disposition of cattle that die on the farm would also have a
> substantial influence on the
>
> spread of BSE if the disease were introduced.” The base case scenario
showed
> that the mean
>
> total number of ID50s (i.e., dosage sufficient to infect 50 percent of
> exposed cattle) from healthy
>
> animals at slaughter presented to the food/feed system was 1500. The mean
> total number of
>
> ID50s from adult cattle deadstock presented to the feed system was 37,000.
> This illustrates the
>
> risk of “4D cattle” (i.e., deadstock).
>
> From the Harvard Risk Assessment, 2001, Appendix 3A Base Case and Harvard
> Risk
>
> Assessment, 2001 Executive Summary
>
> McDonald’s also urges agencies of the US government to work with academia
> and industry on
>
> research in the following areas:
>
> • Methods to inactivate TSEs agents which then may allow a product to be
> used and even
>
> fed to animals without risk
>
> • Alternative uses for animal byproducts which would maintain some value
>
> In July 2004, McDonald’s in cooperation with others sponsored a meeting at
> Penn State. The
>
> purpose of the meeting was to review work conducted by Dr. Bruce Miller
> looking at the
>
> feasibility of using carcasses and animal byproducts as renewable
> alternatives to fossil fuels in
>
> large energy generating boilers. A number of government representatives
were
> also invited to
>
> this meeting. We are aware that Dr. Miller continues this work which shows
> great promise. We
>
> suggest that the FDA explore the possibility of this alternative use that
> may also have a positive
>
> impact on the environment.
>
> The McDonald’s Corporation will continue to work with the FDA and other
> government
>
> agencies to implement a strong BSE risk control program. We would like to
> reiterate our
>
> opinion that for the FDA to provide a more comprehensive and protective
feed
> ban, specified
>
> risk materials (SRMs) and deadstock must be removed from all animal feed
and
> that legal
>
> exemptions which allow ruminant protein to be fed back to ruminants (with
> the exception of
>
> milk) should be discontinued. Thank you for the opportunity to submit
these
> comments to the
>
> public record.
>
> Respectfully,
>
> Dick Crawford
>
> Corporate Vice President, Government Relations
>
> 630-623-6754 Direct
>
> 630-623-3057 Facsimile
>
> dick.crawford@mcd.com
>
>
> C:\Documents and Settings\mc07605\My Documents\MYDATA\BSE - US\FDA\Final
> McD's comments to FDA Rule 12-19-05.doc
>
>
>
>
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273_emc-000134-02.pdf
>
>
>
>
>
> THE SEVEN SCIENTIST REPORT ***
>
>
>
>
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-EC244-Attach-1.pdf
>
>
>
>
>
>
> Date: Sat, 14 Jan 2006 10:08:21 -0600
> Reply-To: Bovine Spongiform Encephalopathy
> Sender: Bovine Spongiform Encephalopathy
> From: "Terry S. Singeltary Sr."
> Subject: Re: McDonald's Corp. seven scientists and experts and a
> pharmaceutical supplier Seriologicals Corp. U.S. NOT PROTECTED
> AGAINST MAD COW DISEASE
>
>
>
> ##################### Bovine Spongiform Encephalopathy
#####################
>
> pharmaceutical supplier Seriologicals Corp.
> 9 December 2005
>
>
> snip...
>
>
> 9 December 2005
> Division of Dockets Management (RFA-305)
> Food and Drug Administration
> 5630 Fishers Lane
> Room 1061
> Rockville, MD 20852
> Re: Docket No: 2002N-0273 (formerly Docket No. 02N-0273)
> Substances Prohibited From Use in Animal Food and Feed
> Dear Sir or Madame:
> Serologicals Corporation is a global provider of biological products to
life
> science companies.
> The Company’s products are essential for the research, development and
> manufacturing of
> biologically based diagnostic, pharmaceutical and biological products.
> customers include
> many of the leading research institutions, diagnostic and pharmaceutical
> companies throughout
> the world. The Company’s products and technologies are used in a wide
> variety of applications
> within the areas of neurobiology, cell signaling, oncology, angiogenesis,
> apoptosis,
> developmental biology, cellular physiology, hematology, immunology,
> cardiology, infectious
> diseases and molecular biology.
> A number of our products are derived from bovine blood or other bovine
> tissues sourced in the
> United States, hence the overall health of the national herd is extremely
> important to our
> company as well as to our customers and their patients. Some of our bovine
> based products are
> used in the manufacture of vaccines and drugs for humans, hence it is
> critical that all measures
> are taken to assure these are safe and free from disease especially Bovine
> Spongiform
> Encephalopathy (BSE). The most effective way to insure this is to create a
> system which
> processes cattle that are BSE free. ...
>
> snip...
>
> The current proposed rule falls short of this and would still leave a
> potential source of infectivity
> in the system. In fact by the FDA’s own statement the exempted tissues
which
> are known to
> have infectivity (such as distal ileum, DRGs, etc) would cumulatively
amount
> to 10% of the
> infectivity in an infected animal, This proposed rule would still allow
for
> the possibility that
> cattle could be exposed to BSE through:
> 1. Feeding of materials currently subject to legal exemptions from the ban
> (e.g., poultry
> litter, plate waste)
> 2. Cross feeding (the feeding of non-ruminant rations to ruminants) on
> farms; and
> 3. Cross contamination of ruminant and non-ruminant feed
> We are most concerned that the FDA has chosen to include a provision which
> would allow
> tissues from deadstock into the feed chain. We do not support the
provision
> to allow the removal
> of brain and spinal cord from down and deadstock over 30 months of age for
> several reasons.
> These are the animals with the highest level of infectivity in tissues
which
> include more than
> brain and spinal cord. We do not feel that there can be adequate removal
and
> enforcement of this
> regulation especially during warmer weather. In addition there is emerging
> information that at
> end stage disease, infectivity may also be included in additionai tissues
> such as peripheral nerves
> (Buschmann and Groschup, 2005).
> Leaving the tissues from these cattle in the animal feed chain will
> effectively nullify the intent of
> this regulation. This point is illustrated by the 2001 Harvard risk
> assessment model which
> demonstrated that eliminating dead and downer, 4D cattle, from the feed
> stream was a
> disproportionately effective means of reducing the risk of re-infection
“The
> disposition of c&e
> that die on the farm would also have a substantial influence on the spread
> of BSE if the disease
> were in traduced. ...
>
> snip...
>
> Respectfully,
> SEROLOGICALS CORPORATION
> James J. Kramer, Ph.D.
> Vice President, Corporate Operations
>
>
>
>
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000383-01-vol35.p
> df
>
>
>
>
>
>
> Date: Tue, 10 Jan 2006 09:39:57 -0600
> Reply-To: Bovine Spongiform Encephalopathy
> Sender: Bovine Spongiform Encephalopathy
> From: "Terry S. Singeltary Sr."
> Subject: MAD COW FEED BAN WARNING LETTER December 21, 2005
>
>
> ##################### Bovine Spongiform Encephalopathy
#####################
>
> 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
>
>
> http://www.fda.gov/foi/warning_letters/g5668d.htm
>
>
>
>
>
> TSS
>
> #################### https://lists.aegee.org/bse-l.html
####################
>
>
> [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk
> Materials for Human Food and Requirement for the Disposition of
> Non-Ambulatory Disabled Cattle
>
> 03-025IFA
> 03-025IFA-2
> Terry S. Singeltary
>
>
> Page 1 of 17
>
> From: Terry S. Singeltary Sr. [flounder9@verizon.net]
>
> Sent: Thursday, September 08, 2005 6:17 PM
>
> To: fsis.regulationscomments@fsis.usda.gov
>
> Subject: [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified
> Risk Materials for Human Food and Requirements
>
> for the Disposition of Non-Ambulatory Disabled Cattle
>
> Greetings FSIS,
>
> I would kindly like to submit the following to [Docket No. 03-025IFA] FSIS
> Prohibition of the Use of Specified Risk Materials for Human Food and
>
> Requirements for the Disposition of Non-Ambulatory Disabled Cattle
>
> THE BSE/TSE SUB CLINICAL Non-Ambulatory Disabled Cattle
>
> Broken bones and such may be the first signs of a sub clinical BSE/TSE
> Non-Ambulatory Disabled Cattle ;
>
> SUB CLINICAL PRION INFECTION
>
> MRC-43-00
>
> Issued: Monday, 28 August 2000
>
> NEW EVIDENCE OF SUB-CLINICAL PRION INFECTION: IMPORTANT RESEARCH
>
> FINDINGS RELEVANT TO CJD AND BSE
>
>
> Terry S. Singeltary Sr.
>
> P.O. Box 42
>
> Bacliff, Texas USA 77518
>
> 9/13/2005
>
>
>
>
> http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf
>
>
>
>
>
> Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE
> SAFEGUARDS (comment submission)
>
>
>
>
>
https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08
> d?OpenDocument
>
>
>
>
>
> Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL
> IMPORTS FROM CANADA
>
>
>
>
>
https://web01.aphis.usda.gov/BSEcom.nsf/0/b78ba677e2b0c12185256dd300649f9d?O
> penDocument&AutoFramed
>
>
>
>
>
> Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION]
>
>
>
>
> http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt
>
>
>
>
>
> Docket Management Docket: 02N-0273 - Substances Prohibited From Use in
>
> Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
>
> Comment Number: EC -10
>
> Accepted - Volume 2
>
>
>
>
> http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html
>
>
>
>
>
> PART 2
>
>
>
> http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.html
>
>
>
>
> Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION
>
>
> TO DOCKET 2003N-0312]
>
>
>
> http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt
>
>
>
>
>
> PDF]Freas, William TSS SUBMISSION
>
> File Format: PDF/Adobe Acrobat -
>
> Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary
>
> Sr. [flounder@wt.net] Monday, January 08,200l 3:03 PM freas ...
>
>
>
> http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf
>
>
>
>
>
> Asante/Collinge et al, that BSE transmission to the 129-methionine
>
> genotype can lead to an alternate phenotype that is indistinguishable
>
> from type 2 PrPSc, the commonest _sporadic_ CJD
>
>
>
>
> http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm
>
>
>
>
>
> Docket: 02N-0276 - Bioterrorism Preparedness; Registration of Food
> Facilities, Section 305
> Comment Number: EC-254 [TSS SUBMISSION]
>
>
>
>
> snip...
>
>
>
>
> Greetings list members,
>
> i just cannot accept this;
>
> > 23 kg of meat in a suitcase (suitcase bomb...TSS)
>
> > The data do not provide a species of origin code for these
>
> > products, therefore they may not contain any ruminant product. what kind
> of statement is this?
>
> how stupid do they think we are? it could also very well mean that _all_
of
> it was ruminant based products !
>
>
> snip...
>
>
> Greetings FDA and public, if you go to the below site, and search all BSE
> known countries and check out their air traffic illegal meat they have
> confiscated, and check out the low number checked, compared to actual
> passenger traffic, would not take too much for some nut to bring in
FMD/TSEs
> into the USA as a 'suitcase bomb'.
>
>
> [[Under APHIS-PPQ's agricultural quarantine inspection monitoring, 284 air
> passengers from Israel were sampled for items of agricultural interest in
> fiscal year 2001. Seven of these passengers, or 2 percent, carried a total
> of 11 kg of meat items that could potentially harbor the pathogen that
> causes BSE. None of these passengers from whom meat items were confiscated
> reported plans to visit or work on a ranch or farm during their visit to
the
> U.S.]]
>
>
> if they were to have questioned the terrorist that bombed the Twin Towers
> with jets, if they were to have questioned them at flight school in the
USA,
> i am sure that they would have said they did not intend to visit the Twin
> Towers as a flying bomb either. what am i thinking, they probably did ask
> this? stupid me.
>
>
> [[In 1999 a small amount of non-species specific meat and offal was
imported
> and a small amount of fetal bovine serum (FBS) was also imported. FBS is
> considered to have a relatively low risk of transmitting BSE.]]
>
>
> more of the USA infamous 'non-species coding system', wonder how many of
> these species are capable of carrying a TSE?
>
>
> snip...
>
>
> Greetings again List Members, let me kick a madcow around here a bit. on
the
> imports from Poland and the infamous USA 'non-species' coding system. the
> USDA/APHIS states;
>
>
> > During the past four years (1998 - 2001), US imports from
>
> > Poland included non-species specific animal products
>
> > used in animal feeds and non-species specific sausage and offal
>
> > products (Table 3). Given US restrictions on ruminant product
>
> > imports, these US imports should not have contained ruminant
>
> > material.
>
>
> NOW, if you read Polands GBR risk assessment and opinion on BSE,
especially
> _cross-contamination_, it states;
>
>
> ANNEX 1 Poland - Summary of the GBR-Assessment, February 2001 EXTERNAL
> CHALLENGE STABILITY INTERACTION OF EXTERNAL CHALLENGE AND STABILITY The
very
> high to extremely high external challenge met a very unstable system and
> could have led to contamination of domestic cattle in Poland from 1987
> onwards. This internal challenge again met the still very unstable system
> and increased over time. The continuing very high external challenge
> supported this development. Not OK MBM-ban since 1997, but no feed
controls.
> Reasonably OK Heat treatment equivalent to 133°C / 20min / 3 bar
standards,
> but no evidence provided on compliance. Not OK. No SRM-ban, SRM are
rendered
> and included in cattle feed. BSE surveillance: Not sufficient before 2001.
> Cross-contamination: Lines for ruminant and non-ruminant feed in
feed-mills
> only separated in time and no analytical controls carried out. Likely
> present since 1987 and growing. see full text and ANNEX 1 at;
>
>
>
> http://europa.eu.int/comm/food/fs/sc/ssc/out185_en.pdf
>
>
>
>
> so in my humble opinion, the statement by the USDA/APHIS that ''these US
> imports _should_ not have contained ruminant materials, is a joke. a sad
> joke indeed. * POLAND BSE GBR RISK ASSESSMENT
>
>
>
>
> http://europa.eu.int/comm/food/fs/sc/ssc/out185_en.pdf
>
>
>
>
> snip...
>
>
> full text;
>
>
>
>
> http://www.fda.gov/ohrms/dockets/dockets/02n0276/02N-0276-EC-254.htm
>
>
>
>
>
> 2006 POLAND BSE
>
>
> Subject: Poland Bse and animal nutrition & bse, scrapie testing Member
> States
> Date: February 8, 2006 at 10:58 am PST
>
> 01/2006 Poland Bse and animal nutrition 7693-2005
>
>
>
>
> http://europa.eu.int/comm/food/fvo/act_getPDF.cfm?PDF_ID=4951
>
>
>
>
>
> Annexes
>
>
> http://europa.eu.int/comm/food/fvo/act_getPDFannx.cfm?ANX_ID=4540
>
>
>
>
> http://europa.eu.int/comm/food/fvo/act_getPDFannx.cfm?ANX_ID=4541
>
>
>
>
>
>
>
> Subject: New case of mad cow disease in Poland
> Date: December 28, 2005 at 10:20 am PST
>
> AFX News Limited
> New case of mad cow disease in Poland
> 12.28.2005, 02:36 AM
>
> WARSAW (AFX) - A new case of bovine spongiform encephalopathy (BSE), or
mad
> cow disease, has been detected in Poland, the country's veterinary service
> said.
>
> The head of the national veterinary service, Krzysztof Jazdzewski, said
that
> the infected animal was found on a farm in the northwest of the country
and
> had been put down.
>
> 'The disease was detected on a farm with a total of 18 animals. Eight of
> them have been identified as exposed to risk (of contamination) and have
> been killed,' he said.
>
> There have been more than 22 cases of mad cow disease in Poland since it
> began testing for BSE in 2001.
>
> newsdesk@afxnews.com
>
> afp/jsa
>
>
> http://www.forbes.com/afxnewslimited/feeds/afx/2005/12/28/afx2416658.html
>
>
>
>
>
>
>
>
> TSS 2001
>
> 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
> To: BSE-L@uni-karlsruhe.de
>
> ######### Bovine Spongiform Encephalopathy
> #########
>
> Greetings List Members,
>
> I was lucky enough to sit in on this BSE conference
> call today and even managed to ask a question.
> that is when the trouble started.
>
> I submitted a version of my notes to
> Sandra Blakeslee of the New York Times,
> whom seemed very upset, and rightly
> so.
>
> "They tell me it is a closed meeting and
> they will release whatever information
> they deem fit. Rather infuriating."
>
> and i would have been doing just fine,
> until i asked my question. i was surprised
> my time to ask a question so quick.
>
> (understand, these are taken from my notes for now.
> the spelling of names and such could be off.)
>
> [host Richard Barns]
> and now a question from Terry S. Singeltary of
> CJD Watch.
>
> [TSS]
> yes, thank you,
> U.S. cattle, what kind of guarantee can you
> give for serum or tissue donor herds?
>
> [no answer, you could hear in the back ground,
> mumbling and 'we can't. have him ask the question
> again.]
>
> [host Richard]
> could you repeat the question?
>
> [TSS]
> U.S. cattle, what kind of guarantee can you
> give for serum or tissue donor herds?
>
> [not sure whom ask this]
> what group are you with?
>
> [TSS]
> CJD Watch, my Mom died from hvCJD and we are
> tracking CJD world-wide.
>
> [not sure who is speaking]
> could you please disconnect Mr. Singeltary
>
> [TSS]
> you are not going to answer my question?
>
> [not sure whom speaking]
> NO
>
> from this point, i was still connected, got to listen
> and tape the whole conference. at one point someone
> came on, a woman, and ask again;
>
> [unknown woman]
> what group are you with?
>
> [TSS]
> CJD Watch and my Mom died from hvCJD
> we are trying to tract down CJD and other
> human TSE's world wide. i was invited to
> sit in on this from someone inside the USDA/APHIS
> and that is why i am here. do you intend on banning
> me from this conference now?
>
> at this point the conference was turned back up,
> and i got to finish listening. They never answered
> or even addressed my one question, or even addressed
> the issue. BUT, i will try and give you a run-down
> for now, of the conference.
>
> IF i were another Country, I would take heed to my
> notes, BUT PLEASE do not depend on them. ask for
> transcript from;
>
> RBARNS@ORA.FDA.GOV
> 301-827-6906
>
> he would be glad to give you one ;-)
>
> Rockville Maryland,
> Richard Barns Host
>
> BSE issues in the U.S.,
> How they were labelling ruminant feed?
> Revising issues.
>
> The conference opened up with the explaining of
> the U.K. BSE epidemic winding down with about 30
> cases a week.
>
> although new cases in other countries were now
> appearing.
>
> Look at Germany whom said NO BSE and now have BSE.
>
> BSE increasing across Europe.
>
> Because of Temporary Ban on certain rendered product,
> heightened interest in U.S.
>
> A recent statement in Washington Post, said the
> New Administration (old GW) has a list of issues.
> BSE is one of the issues.
>
> BSE Risk is still low, minimal in U.S. with a greater
> interest in MBM not to enter U.S.
>
> HOWEVER, if BSE were to enter the U.S.
> it would be economically disastrous
> to the render, feed, cattle, industries,
> and for human health.
>
> (human health-they just threw that in cause i was listening. I will now
> jot down some figures in
> which they told you, 'no need to write them down'.
> just hope i have them correct. hmmm, maybe i hope
> i don't ???)
>
> 80% inspection of rendering
>
> *Problem-Complete coverage of rendering HAS NOT
> occurred.
>
> sizeable number of 1st time FAILED INITIAL INSPECTION,
> have not been reinspected (70% to 80%).
>
> Compliance critical, Compliance poor in U.K.
> and other European Firms.
>
> Gloria Dunason
> Major Assignment 1998 goal TOTAL compliance.
> This _did not_ occur. Mixed level of compliance,
> depending on firm.
>
> Rendering FDA license and NON FDA license
>
> system in place for home rendering & feed
> 76% in compliance
> 79% cross contamination
> 21% DID NOT have system
> 92% record keeping
> less than 60% total compliance
>
> 279 inspectors
> 185 handling prohibited materials
>
> Renderer at top of pyramid, significant
> part of compliance.
> 84% compliance
>
> failed to have caution statement render
> 72% compliance & cross contamination
> caution statement on feed, 'DO NOT FEED TO CATTLE'
>
> 56 FIRMS NEVER INSPECTED
>
> 1240 FDA license feed mills
> 846 inspected
>
> "close to 400 feed mills have not been inspected"
>
> 80% compliance for feed.
>
> 10% don't have system.
>
> NON-FDA licensed mills
> There is NO inventory on non licensed mills.
> approximately 6000 to 8000 Firms ???
> 4,344 ever inspected.
> "FDA does not have a lot of experience with"
>
> 40% do NOT have caution statement 'DO NOT FEED'.
>
> 74% Commingling compliance
>
> "This industry needs a lot of work and only half
> gotten to"
>
> "700 Firms that were falitive, and need to be
> re-inspected, in addition to the 8,000 Firms."
>
> Quote to do BSE inspection in 19 states by end
> of January or 30 days, and other states 60 days.
> to change feed status??? Contract check and ask
> questions and pass info.
>
> At this time, we will take questions.
>
> [I was about the third or fourth to ask question.
> then all B.S.eee broke loose, and i lost my train
> of thought for a few minutes. picked back up here]
>
> someone asking about nutritional supplements and
> sourcing, did not get name. something about inspectors
> not knowing of BSE risk??? the conference person assuring that Steve
> Follum? and the TSE advisory Committee were
> handling that.
>
> Some other Dr. Vet, whom were asking questions
> that did not know what to do???
>
> [Dennis Wilson]
> California Food Agr.
> Imports, are they looking at imports?
>
> [Conference person]
> they are looking at imports,
> FDA issued imports Bulletin.
>
> [Linda Singeltary ??? this was a another phone in
> question, not related i don't think]
> Why do we have non-licensed facilities?
>
> (conference person)
> other feed mills do not handle as potent drugs???
>
> Dennis Blank, Ken Jackson
> licensed 400
> non FDA 4400 inspected of a total of 6000 to 8000,
>
> (they really don't know how many non licensed Firms
> in U.S. they guess 6000 to 8000??? TSS)
>
> Linda Detwiler
> asking everyone (me) not to use emergency BSE number,
> unless last resort.
> (i thought of calling them today, and reporting the
> whole damn U.S. cattle herd ;-) 'not'
>
> Warren-Maryland Dept. Agr.
> Prudent to re-inspect after 3 years.
> concerned of Firms that have changed
> owners.
>
> THE END
>
> TSS
>
> ############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html
> ############
>
>
> FROM New York TIMES
>
> Subject: Re: BSE 50 STATE CONFERENCE CALL thread from BSE List and FDA
> Posting of cut version...
> Date: Thu, 11 Jan 2001 22:02:47 -0700
> From: "Sandy Blakeslee"
> To: "Terry S. Singeltary Sr."
> References: 1
>
> Hi terry -- thanks for all your help. I know it made a difference with
> the FDA getting out that release.
>
>
>
> From the New York Times NYTimes.com, January 11, 2001
>
> Many Makers of Feed Fail to Heed Rules on Mad Cow Disease
> By SANDRA BLAKESLEE
>
> Large numbers of companies involved in manufacturing animal feed are not
> complying with regulations meant to prevent the
> emergence and spread of mad cow disease in the United States, the Food
> and Drug Administration said yesterday.
>
> The widespread failure of companies to follow the regulations, adopted
> in August 1997, does not mean that the American food supply is unsafe,
> Dr. Stephen Sundlof, director of the Center for Veterinary Medicine at
> the F.D.A., said in an interview.
>
> But much more needs to be done to ensure that mad cow disease does not
> arise in this country, Dr. Sundlof said.
>
> The regulations state that feed manufacturers and companies that render
> slaughtered animals into useful products generally may not feed mammals
> to cud-chewing animals, or ruminants, which can carry mad cow disease.
>
> All products that contain rendered cattle or sheep must have a label
> that says, "Do not feed to ruminants," Dr. Sundlof said. Manufacturers
> must also have a system to prevent ruminant products from being
> commingled with other rendered material like that from chicken, fish or
> pork. Finally, all companies must keep records of where their products
> originated and where they were sold.
>
> Under the regulations, F.D.A. district offices and state veterinary
> offices were required to inspect all rendering plants and feed mills to
> make sure companies complied. But results issued yesterday demonstrate
> that more than three years later, different segments of the feed
> industry show varying levels of compliance.
>
> Among 180 large companies that render cattle and another ruminant,
> sheep, nearly a quarter were not properly labeling their products and
> did not have a system to prevent commingling, the F.D.A. said. And among
> 347 F.D.A.-licensed feed mills that handle ruminant materials - these
> tend to be large operators that mix drugs into their products - 20
> percent were not using labels with the required caution statement, and
> 25 percent did not have a system to prevent commingling.
>
> Then there are some 6,000 to 8,000 feed mills so small they do not
> require F.D.A. licenses. They are nonetheless subject
> to the regulations, and of 1,593 small feed producers that handle
> ruminant material and have been inspected, 40 percent
> were not using approved labels and 25 percent had no system in place to
> prevent commingling.
>
> On the other hand, fewer than 10 percent of companies, big and small,
> were failing to comply with the record-keeping
> regulations.
>
> The American Feed Industry Association in Arlington, Va., did not return
> phone calls seeking comment.
>
> http://www.nytimes.com/2001/01/11/science/11COW.html
>
> Subject:
> USDA/APHIS response to BSE-L--U.S. 50 STATE CONFERENCE CALL
> Jan. 9, 2001
> Date:
> Wed, 10 Jan 2001 14:04:21 -0500
> From:
> "Gomez, Thomas M."
> Reply-To:
> Bovine Spongiform Encephalopathy
> To:
> BSE-L@uni-karlsruhe.de
>
>
>
> ######### Bovine Spongiform Encephalopathy
> #########
>
> USDA/APHIS would like to provide clarification on the following point
> from
> Mr. Singeltary's 9 Jan posting regarding the 50 state conference call.
>
> [Linda Detwiler asking everyone (me) not to use emergency BSE number,
> unless
> last resort. (i thought of calling them today, and reporting the whole
> damn
> U.S. cattle herd ;-) 'not']
>
> Dr. Detwiler was responding to an announcement made during the call to
> use
> the FDA emergency number if anyone wanted to report a cow with signs
> suspect
> for BSE. Mr. Singeltary is correct that Dr. Detwiler asked participants
> to
> use the FDA emergency number as a last resort to report cattle suspect
> for
> BSE. What Mr. Singeltary failed to do was provide the List with Dr.
> Detwiler's entire statement. Surveillance for BSE in the United States
> is a
> cooperative effort between states, producers, private veterinarians,
> veterinary hospitals and the USDA. The system has been in place for
> over 10
> years. Each state has a system in place wherein cases are reported to
> either the State Veterinarian, the federal Veterinarian in Charge or
> through
> the veterinary diagnostic laboratory system. The states also have
> provisions with emergency numbers. Dr. Detwiler asked participants to
> use
> the systems currently in place to avoid the possibility of a BSE-suspect
> report falling through the cracks. Use of the FDA emergency number has
> not
> been established as a means to report diseased cattle of any nature.
>
> ############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html
> ############
>
> Subject:
> Re: USDA/APHIS response to BSE-L--U.S. 50 STATE CONFERENCE
> CALL Jan.9, 2001
> Date:
> Wed, 10 Jan 2001 13:44:49 -0800
> From:
> "Terry S. Singeltary Sr."
> Reply-To:
> Bovine Spongiform Encephalopathy
> To:
> BSE-L@uni-karlsruhe.de
> References:
> 1
>
>
>
> ######### Bovine Spongiform Encephalopathy
> #########
>
> Hello Mr. Thomas,
>
> > What Mr. Singeltary failed to do was provide
> > the List with Dr. Detwiler's entire statement.
>
> would you and the USDA/APHIS be so kind as to supply
> this list with a full text version of the conference
> call and or post on your web-site?
> if so when, and thank you.
> if not, why not?
>
> > The system has been in place for over 10 years.
>
> that seems to be a very long time for a system to be in
> place, and only test 10,700 cattle from some 1.5 BILLION head (including
> calf crop). Especially since French
> are testing some 20,000 weekly and the E.U. as a whole,
> are testing many many more than the U.S., with less
> cattle, same risk of BSE/TSEs.
>
> Why does the U.S. insist on not doing massive testing
> with the tests which the E.U. are using?
> Why is this, please explain?
>
> Please tell me why my question was not answered?
>
> > U.S. cattle, what kind of guarantee can you
> > give for serum or tissue donor herds?
>
> It was a very simple question, a very important
> question, one that pertained to the topic of
> BSE/feed, and asked in a very diplomatic way.
> why was it not answered?
>
> If all these years, we have been hearing that
> pharmaceutical grade bovines were raised for
> pharmaceuticals vaccines etc. But yet the
> USA cannot comply with feed regulations of
> the ruminant feed ban, PLUS cannot even
> comply with the proper labelling of the feed,
> cross contamination etc.
> Then how in the world can you Guarantee the feed
> fed to pharmaceutical grade bovine, were actually
> non ruminant feed?
>
> Before i was ask to be 'disconnected',
> i did hear someone in the background
> say 'we can't'-- have him ask the question again.
>
> could you please be so kind, as to answer these
> questions?
>
> thank you,
> Terry S. Singeltary Sr. Bacliff, Texas USA
>
> P.S. if you will also notice, i did not post that
> emergency phone number and do not intend on passing
> it on to anyone. I was joking when i said i should
> call and report the whole damn U.S. Herd. So please
> pass that on to Dr. Detwiler, so she can rest easily.
>
> BUT, they should be reported, some are infected with TSE.
> The U.S. is just acting as stupid as Germany and other
> Countries that insist they are free of BSE.
>
> TSS
>
>
> ----- Original Message -----
> From: "Terry S. Singeltary Sr."
> To:
> Sent: Thursday, January 11, 2001 2:06 PM
> Subject: BSE 50 STATE CONFERENCE CALL thread from BSE List and FDA
> Posting of cut version...SNIP...END
>
> #################### https://lists.aegee.org/bse-l.html
> ####################

Follow Ups:

Post a Followup