# Deer Repelleant- Cattle blood



## M1Garand (Apr 12, 2006)

Sent the email this morning, so when I hear back, I'll post what they say.


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## M1Garand (Apr 12, 2006)

I heard back regarding my email referencing prions in plantskydd:


Hello 


Thank you for your inquiry regarding Plantskydd Deer Repellent.


Plantskydd is now made from Canadian sourced 100%* porcine* dried blood, and is packaged in the USA. Hence, there is no chance of infected bovine sourced prions to be transmitted or 'picked up' by other animals where Plantskydd has been applied.


We switched from bovine to porcine to satisfy Canadian importation regulations, not because of BSE concerns.The import restrictions were politically motivated, not science based.


note: The bovine dried blood we formally used contained no animal renderings (bone tripe, brain or muscle tissue etc.), only the hemoglobyn portion of red blood cells.


OMRI: Plantskydd Repllent was the first animal repellent to be Listed by the USDA recognized Organic Material Review Institute, as suitable for use in the production of food and fibre.


I have enclosed as eMail attachments two documents which may be of interest to you.


If you have further questions, I will be pleased to answer them.



Claude P. Boisvert
Corporate Communications, President
TREE WORLD Plant Care Products, Inc.

Primary Distributor: * Plantskydd * Animal Repellent
* 100% natural ingredients * Proven Effective! -
*www.plantskydd.com* or * www.treeworld.com*


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## M1Garand (Apr 12, 2006)

*Attachement #1, I haven't been able to open the second one:*

​​*Experts soothe worries about using bone, blood meal *

January 7, 2004 The Oregonian by Kym PokornySummary: Chances of getting mad cow disease from garden fertilizer are slim 
Concern about mad cow disease is expanding past the meat counter as gardeners worry that bone and blood meal sprinkled on their soil could make them sick. 
Experts say scientific evidence is scant or nonexistent on the danger of such products made from rendered cow parts, but add there's an easy way to play it safe: Don't use them. 
"If you're worried about using bone meal in the garden, use a mask," says Rich Baer, a plant pathologist and rosarian. "If you're really worried, don't use it." 
Safety concerns about bone meal have turned into something of an urban legend, according to Dalton Hobbs, spokesman for the Oregon Department of Agriculture, but he knows of no evidence that bovine spongiform encephalopathy (BSE) can be contracted by inhaling bone meal dust. 
"One would think there is a theoretical possibility, but that has not been documented as a form of spreading BSE," he says. 
The same goes for plants taking up the prion protein that causes BSE and passing it on to humans who eat them. 
"I've never even heard anyone hypothesize on that," says Baer, who has degrees in plant pathology and plant physiology. "Protein molecules tend to be fairly large. Plants don't tend to absorb anything of that size through their cell walls." 
So far, research shows that BSE is spread in cattle through feed containing diseased animal byproducts. People seem to get the human form of BSE by eating meat from infected cattle, though only certain parts. The prion protein that's thought to cause BSE has been found in the brain, spinal cord and small intestine of beef, according to Hobbs, but not in blood, bone, milk or muscle (which is most of the meat we eat). 
Parts of the cow (hooves, bones and innards) that don't end up in the grocery store for human consumption are sent to rendering facilities, where they're boiled down, ground up and made into any number of products, including bone meal and blood meal sold as plant nutrients. The new U.S. Department of Agriculture regulations restricting "downers," cows that can't stand or walk, from being slaughtered for human consumption don't apply to bone meal production. 
"No one's said a thing about what we put in our gardens," says Dona Koepke, a gardener in Lake Oswego. "I just bought a huge thing of organic fertilizer and part of it was bone meal. I hadn't thought about it before, but if it's made from diseased tissue, can it be taken up by plants, how long does it stay in the ground? 
"We think we're doing something good for our garden, but are we?" 
Plants need three major nutrients to survive: nitrogen, phosphorus and potassium. Bone meal provides an organic source of phosphorus, needed for root development, and a little nitrogen, used by the plant for healthy growth. Blood meal is a good source of nitrogen. But there are alternatives. 
Sales of blood meal at Concentrates, a Portland distributor of organic products, have dropped by about half since the discovery of mad cow disease in Great Britain more than a decade ago, according to manager Heather Havens. But a big reason for that decline is the increased availability of feather meal, which not only offers nitrogen but offers it in a form that's released slower than blood meal. And it's cheaper. 
Bone meal, on the other hand, continues to sell well, she says. Sales dipped a bit during Britain's scare and then leveled off. 
"It works well and has been used for so long. It's almost like a folk remedy. I think people will always use it," Havens says. 
But they don't have to. "People who have reservations have switched to fish bone meal," she says. "You get more phosphorus per dollar, per pound at no risk." 
The Royal Horticulture Society recommended in 1996 that gardeners wear face masks to avoid inhaling bone meal dust. "Any dust that you're working with, whether it's sanding the woodwork inside the house or working with lime in the front yard, it's best not to inhale," says Jan McNeilan, horticulture agent for Oregon State University Extension Service. "A simple mask would take care of that." 
The thing to remember, according to Hobbs, is that the risk of getting BSE is minimal. "Only 200 people have contracted it and of those, 150 were in England where they had 200,000 infected cattle. That's a huge reservoir of infected meat. We've found one.


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## M1Garand (Apr 12, 2006)

I was able to open the other attachment:


*PRODUCT SAFETY -- Plantskydd®​​*I am pleased to provide you with information regarding Plantskydd​-- a Swedish formula animal repellent--now made in the USA using 100% natural ingredients. There are no synthetic additives or chemicals added.​​Plantskydd--soluble powder formulation:​* ACTIVE ingredient: dried blood (porcine) --99.84%
* INERT ingredient: vegetable oil--0.16%
On April 4, 2003, following a fifty-two month scientific review process, the Canadian Pesticide Management Regulatory Agency (PMRA), assigned Plantskydd Repellent the pesticide registration PCP# 27411.
*Note: Due to the benign nature of the ingredients, an MSDS (Material Safety Data Sheet) is not required for this product in Canada.
*Sweden is recognized throughout the world for its high consumer and worker safety standards. In Sweden, Plantskydd is assigned the lowest category for pesticide toxicity and environmental impact--Class 3 = OK for home garden use. No protection device is required e.g., gloves, mask, etc.
Under the Certification provisions of the Forest Stewardship Council--FSC, foresters in Sweden may now only use Class 3 products. 
Plantskydd is also available for home garden use in Germany-- a country with the most stringent health & environmental protection laws in the world.
EPA-- U.S. Environmental Protection Agency
In the United States, dried blood is an exempted product/minimum risk pesticide and is exempt from the Federal Insecticide, Fungicide, and Rodenticide Act requirements and therefore, is not subject to federal registration.
_"The EPA has determined that the use of these pesticides poses insignificant risks to human health or the environmentand the burden imposed by the regulation(s) is, therefore, not justified.
" The Agency (EPA) in promulgating this rule, is responding to society's increasing demand for more natural and benign methods of pest control, and to the desire to reduce governmental regulations and ease the burden on the public."_ 
May 6, 1996 EPA --USA
The 'active' ingredient in Plantskydd is Export Grade (highest) dried blood from North American sources*.* *There are no animal part renderings used*. The blood is separated into haemoglobin and plasma. The haemoglobin is then dried to a powder by exposing it to intense 260 ºC (500 ºF) heat. The resulting product is sterile and bacteria free. The pre-mixed RTU liquid formulation is sterilized by irradiation--the same process used for many food and pharmaceutical products. Plantskydd's 'inert' ingredient is a food grade vegetable oil.

*OMRI -- the Organic Materials Review Institute 'Lists' Plantskydd powder concentrate as suitable for use in the production of organic foods and fibre 
(trw-9589).
*Throughout Europe and North America, dried blood is often used as a food additive in products such as: blood-based sausages, meat colouring, an iron enrichment supplement and as a binder agent in bakery products. 


Plantskydd has proven effective at substantially reducing browse damage from: deer, elk, hare, moose, mountain beaver, nutria, possum, rabbits, and other herbaceous animals. For information regarding Field Trials, user Testimonials, FAQ's, and a listing of authorized Dealers and Distributors, please be sure to visit our website: www.plantskydd.com


If you have any further questions regarding the safety of this product, I will be pleased to answer them for you. 
Claude P. Boisvert
President & CEO -- Tree World 

e-Mail: [email protected]
Toll Free: 1-800-252-6051


TREE WORLD--CANADA 
4466 Stalashen Drive, Sechelt, British Columbia, V0N 3A1

TREE WORLD, Inc--USA
4413 N.E. 14th Street (P.O. Box 4821) DesMoines, IA. 50306
*** Primary Agent -- PLANTSKYDD animal repellent ***


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## sadocf1 (Mar 10, 2002)

Hey- how about dog food? Contains ruminant protein


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## terry (Sep 13, 2002)

##################### Bovine Spongiform Encephalopathy #####################

This is great news! Canada far exceeds the USAs FDAs partial feed ban _with_
continued breaches in the USDA et al's triple fire walls for BSE ;

FLIP ;


C. Animal Feed Restrictions

Specified Risk Materials (SRMs)
In the ``Feed Restrictions'' section of the report, the IRT
recommended: ``All SRM should be excluded from all animal feed,
including pet food.'' [p. 5] FDA has prohibited the use of most
mammalian proteins in ruminant feed since 1997. The IRT report stated
that, ``Considering the BSE situation in North America, the [IRT]
believes the partial (ruminant to ruminant) feed ban that is currently
in place is insufficient to prevent exposure of cattle to the BSE
agent.'' [p. 5] The IRT further stated that, ``While science would
support the feed bans limited to the prohibition of ruminant derived
[meat and bone meal] MBM in ruminant feed, practical difficulties of
enforcement demand more pragmatic and effective solutions.'' [p. 6]
Specifically, the IRT cited epidemiological evidence in the United
Kingdom that highlight the dangers of cattle infection through the
consumption of feed that had been contaminated accidentally when
manufactured in premises that legitimately used mammalian meat and bone
meal in feed for pigs and poultry. [p. 5] In addition, the IRT report
cited an ongoing attack rate study at the Veterinary Laboratories
Agency in the United Kingdom that demonstrates

[[Page 42297]]

transmission of BSE with 10 mg of infectious brain tissue. [p. 5]
Although not yet published, more recent results from this study have
demonstrated transmission with a lower dose of infectious brain tissue.
These levels are significantly lower than the 1 gram infectious dose
that had been demonstrated in the same study at the time the 1997 BSE
feed rule was issued. Further, the Harvard-Tuskegee Study showed that
removing SRMs from all animal feed reduces by 88 percent the potential
exposure of cattle to the BSE agent when 10 BSE infected cattle are
introduced into the United States. Accordingly, FDA has tentatively
concluded that it should propose removing SRMs from all animal feed to
adequately control the risks associated with cross contamination
throughout feed manufacture and distribution and with intentional or
unintentional misfeeding on the farm. FDA is currently working on a
proposal to accomplish this goal.


http://www.fda.gov/OHRMS/DOCKETS/98fr/04-15882.htm



http://www.fda.gov/OHRMS/DOCKETS/98fr/05-20196.htm


III. Significance of Guidance

This level 1 guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidance represents
the agency's current thinking about the manufacture and labeling of raw
meat foods for companion and captive noncompanion carnivores and
omnivores. It does not create or confer any rights for or on any person
and will not operate to bind FDA or the public. An alternative approach
may be used if such approach satisfies the requirements of the
applicable statutes and regulations.


http://www.fda.gov/OHRMS/DOCKETS/98fr/04-11366.htm


FLOP ;


Currently in the U.S. , animal products that are prohibited from cattle feed
are _acceptable_ for use in pet food. Such products include meat and bone
meal, for example. However, FDA believes that the safeguards it has put into
place (i.e. ruminant feed rule) to prevent BSE in the U.S. have also
protected cats. To date, no case of FSE has been found in the U.S. FDA
continues to review these safeguards to be sure they are adequate,
especially in light of the BSE case found in Washington State in December,
2003. ...



http://www.fda.gov/cvm/petfoods.htm



BSE, BOVINE - USA: FEED RECALL
*******************************
A ProMED-mail post
<http://www.promedmail.org>
ProMED-mail is a program of the
International Society for Infectious Diseases
<http://www.isid.org>

Date: 21 Jun 2006
From: Terry Singeltary <[email protected]>
Source: Chron.com, 20 Jun 2006 [edited]
<http://www.chron.com/disp/story.mpl/ap/fn/3987413.html>


Mad Cow Feed Recall, USA, Albertville, AL, 16 Jun 2006; Feed Recalled
Over Mad Cow Violation
-----------------------------------------------
Livestock feed ingredients shipped to 9 states may have been
contaminated with cattle remains in violation of a 1997 ban to
protect against mad cow disease, a manufacturer said Tuesday [20 Jun 2006].

H.J. Baker & Bro. Inc. said it was recalling 3 livestock feed
ingredients, including 2 used to supplement feed given to dairy cows.
A sample tested by the Food and Drug Administration was positive for
cattle meat and bone meal, said Mark Hohnbaum, president of the
Westport, Connecticut-based company's feed products group.

"This is very concerning to us. This isn't something that happens to
us. We are very serious about food safety," Hohnbaum said. Mad cow
disease is only known to spread when cows eat feed containing brain
and other nerve tissue from infected cattle. Protein from cattle was
commonly added to cattle feed to speed growth until the ban largely
outlawed the practice.

Cattle tissue may have contaminated 2 feed ingredients given to dairy
cows -- Pro-Lak and Pro-Amino II -- made by H.J. Baker between August
2005 and June 2006. The 3rd of the recalled ingredients, Pro-Pak with
Porcine Meat and Bone, was mislabeled. It is used in poultry feed.

The company announced the recall in the wake of ongoing FDA
inspections of its Albertville, Alabama plant, Hohnbaum said. The
inspections have found manufacturing and clerical issues, he added.

The company shipped the ingredients to feed manufacturers and dairy
farms in the following states: Alabama, California, Florida, Georgia,
Kentucky, Louisiana, Michigan, Mississippi and Tennessee. The company
is notifying its customers of the voluntary recall. It does not know
how much of the feed ingredients it sold, Hohnbaum said.

On the Net:
Food and Drug Administration animal feed information:
<http://www.fda.gov/cvm/animalfeed.htm>

--
Terry S. Singeltary Sr.
<[email protected]>

[The company is already notifying its customers. Furthermore, the
company does not know how much feed was contaminated, so they are
likely being very cautious and notifying customers, although they may
not have had animals exposed.

It is likely the company does not know how much contamination each
batch of feed received.

Customers should be forewarned that even if an animal consumes some
of this feed, it does not mean it is sure to come down with Bovine
Spongiform Encephalopathy (BSE). It takes a certain amount of
infective material being consumed as well as certain conditions
within the animal for BSE to develop.

What is intriguing about this event is that, though the FDA will fine
the feed manufacturer, on-farm mixing of feed that may contain
prohibited material does not find its way onto the FDA radar screen.
There have been multiple cases of farm-site feed mixing with
confirmation of prohibited material being in the feed, and the feed
being fed to cattle. When this apparent oversight was brought to the
attention of the FDA, the reply was that they [the FDA] did not
believe they had jurisdiction over the farm, only the manufacturers.
Since the FDA could not demonstrate a prion to a court of law, they
did not see how they could prosecute a case of farm-site feed mixing.

Clearly, had the international team that surveyed the situation in
the US during 2004 known of this approach, their recommendations may
well have been different.

Without adherence to the feeding rules, cases of BSE in the United
States will likely continue to occur on a sporadic basis. - Mod.TG]

[see also:
2004
----
BSE, bovine - USA (WA) (16): new regulations 20040318.0747
BSE, bovine - USA: APHIS report 20040205.0426
2003
----
BSE, bovine - USA (WA) (09): new regulations 20031230.3172]
..................tg/msp/mpp

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> ##################### Bovine Spongiform Encephalopathy
#####################
>
> CANADA STRENGTHENS FEED CONTROLS
>
> OTTAWA, June 26, 2006 (15:00 EST) - The Canadian Food Inspection Agency
> is banning cattle tissues capable of transmitting bovine spongiform
> encephalopathy (BSE) from all animal feeds, pet foods and fertilizers.
> The enhancement will significantly accelerate Canada's progress toward
> eradicating the disease from the national cattle herd by preventing more
> than 99% of any potential BSE infectivity from entering the Canadian
> feed system.
>
> The banned tissues, which are collectively known as specified risk
> material (SRM), have been shown in infected cattle to contain
> concentrated levels of the BSE agent. Canada has already applied
> identical protection to the human food system, where SRM are removed
> from all cattle slaughtered for human consumption. This measure is
> internationally recognized as the most effective way to protect the
> safety of food from BSE.
>
> "This ban tightens already strong, internationally recognized feed
> controls and shortens the path we must follow to move beyond BSE," said
> the Honourable Chuck Strahl, Minister of Agriculture and Agri-Food and
> Minister for the Canadian Wheat Board. "Preventing all these materials
> from entering the animal feed chain minimizes risks and demonstrates the
> commitment of Canada's new government to take necessary, science-based
> actions to address BSE."
>
> Ongoing surveillance testing continues to indicate that the level of BSE
> in Canada is very low. This is attributable to Canada's current feed
> ban, which has prohibited the use of SRM in feed for cattle and other
> ruminant animals since 1997. Extending SRM controls to all animal feeds
> addresses potential contamination that could occur during feed
> production, transportation, storage and use. Removing SRM from pet food
> and fertilizers is intended to mitigate the risk associated with the
> potential exposure of cattle and other susceptible animals to BSE
> through the misuse of these products.
>
> The new outcome-based regulations enter into force on July 12, 2007,
> with additional time provided for small establishments to achieve full
> compliance. In the meantime, an awareness campaign will be undertaken to
> ensure that all regulated parties are fully aware of their
> responsibilities and have adjusted their practices and procedures as
> required. Special emphasis will be placed on working closely and in full
> cooperation with small abattoirs to help them transition to the new
> requirements and facilitate their long-term viability. The Government
> has set aside $80 million to work with the provinces to assist
> industry's implementation of the new feed controls.
>
> Enhanced feed controls complete the Government's response to the
> detection of BSE, consistent with the recommendations of the
> international team of experts that reviewed Canada's situation. As a
> priority, Canada first focused on human health protection, which was
> achieved through the removal of SRM from the food system. Attention then
> turned to animal health measures through intensified surveillance
> testing for BSE and increased animal tracing capabilities.
>
> SRM are defined as the skull, brain, trigeminal ganglia (nerves attached
> to the brain), eyes, tonsils, spinal cord and dorsal root ganglia
> (nerves attached to the spinal cord) of cattle aged 30 months or older
> and the distal ileum (portion of the small intestine) of cattle of all
> ages.
>
> For more information:
> Fact Sheet: Canada's Enhanced Feed Ban
>
> http://www.inspection.gc.ca/english/anima/feebet/rumin/enhrene.shtml
>
> #################### https://lists.aegee.org/bse-l.html
####################
>

#################### https://lists.aegee.org/bse-l.html ####################


##################### Bovine Spongiform Encephalopathy #####################

FOR IMMEDIATE RELEASE
Statement
June 26, 2006
Media Inquiries: 
Rae Jones, 301-827-6242
Consumer Inquiries: 
888-INFO-FDA



FDA Statement on Canadian Rule to Control BSE Risks
The Food and Drug Administration (FDA) is aware of the release of a final rule by the Canadian Food Inspection Agency (CFIA) to extend protections in Canada against the risks of bovine spongiform encephalopathy (BSE), so-called Mad Cow disease. The rule is an addition to existing Canadian measures to ban risky ingredients in animal feed -- measures that have provided significant safeguards to protect the health of both United States and Canadian cattle fed animal feed from Canada, and thereby have protected consumers of beef in both countries. 

The Canadian approach to BSE prevention is similar to FDA's approach, and the public health agencies of both countries have been in close touch as they have developed their respective regulations. Both countries' BSE feed rules are designed to forestall the spread of the disease and its related human form, variant Creutzfeldt-Jakob Disease, through BSE-infected animal feed. The FDA BSE feed rule, which has been in effect since 1997, has proved its effectiveness as a key component of a tiered firewall against BSE; to date, there have been only three cows found with BSE in the United States, and each of them was either imported, or old enough to have consumed animal feed manufactured before the regulation took effect. 

Nevertheless, since the detection of the first BSE-positive cow in the United States, FDA has been actively exploring various ways to further strengthen its existing feed rule which prohibits the use of certain mammalian protein in feed for cattle and other ruminants. Even though the risk of BSE is extremely low, in October 2005, the agency issued a proposed rule that would prohibit the use of certain high risk cattle materials in all animal feed to further reduce an already low probability event. The agency is in the process of analyzing and evaluating the approximately 800 public comments submitted to the FDA about this proposal. 

FDA and HHS are committed to continuing to protect animal health and consumers against the spread of BSE through animal feed in the United States . After FDA considers the public comments on the proposal issued in October 2005, the agency and HHS plan to develop and issue a final rule as expeditiously as possible. 

#### 


http://www.fda.gov/bbs/topics/NEWS/2006/NEW01397.html 




>>>to date, there have been only three cows found with BSE in the United States, and each of them was either imported, or old enough to have consumed animal feed manufactured before the regulation took effect. <<< 


PLEASE NOTE, key word here ''found''. 

does not mean that there are many more that they refused to find, considering the terribly flawed USDA june 2004 enhanced BSE cover-up, all of which has been well documented on this list. 


>>>The agency is in the process of analyzing and evaluating the approximately 800 public comments submitted to the FDA about this proposal. <<< 

>>>The FDA BSE feed rule, which has been in effect since 1997, has proved its effectiveness as a key component of a tiered firewall against BSE<<< 


while were all still holding our breath here, the mad cow agent continues to amplify and spread through the USA livestock community via the terribly flawed USDA/FDA BSE 'tiered firewall' and that very recent 9 state recall of feed product containing potential mad cow disease. ... 

still disgusted in sunny bacliff, texas 


TSS


#################### https://lists.aegee.org/bse-l.html ####################

CONTINUED..........


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## terry (Sep 13, 2002)

##################### Bovine Spongiform Encephalopathy #####################

Subject: MAD COW FEED BAN WARNING LETTER ISSUED MAY 17, 2006
Date: June 27, 2006 at 7:42 am PST 
Public Health Service 
Food and Drug Administration

New Orleans District
297 Plus Park Blvd.
Nashville, TN 37217 

Telephone: 615-781-5380
Fax: 615-781-5391



May 17, 2006 

WARNING LETTER NO. 2006-NOL-06 

FEDERAL EXPRESS
OVERNIGHT DELIVERY 

Mr. William Shirley, Jr., Owner
Louisiana.DBA Riegel By-Products
2621 State Street
Dallas, Texas 75204 

Dear Mr. Shirley: 

On February 12, 17, 21, and 22, 2006, a U.S. Food & Drug Administration (FDA) investigator inspected your rendering plant, located at 509 Fortson Street, Shreveport, Louisiana. The inspection revealed significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 [21 CFR 589.2000], Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). You failed to follow the requirements of this regulation; products being manufactured and distributed by your facility are misbranded within the meaning of Section 403(a)(1) [21 USC 343(a)(1)] of the Federal Food, Drug, and Cosmetic Act (the Act). 

Our investigation found you failed to provide measures, including sufficient written procedures, to prevent commingling or cross-contamination and to maintain sufficient written procedures [21 CFR 589.2000(e)] because: 

You failed to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues into animal protein or feeds which may be used for ruminants. For example, your facility uses the same equipment to process mammalian and poultry tissues. However, you use only hot water to clean the cookers between processing tissues from each species. You do not clean the auger, hammer mill, grinder, and spouts after processing mammalian tissues. 

You failed to maintain written procedures specifying the clean-out procedures or other means to prevent carryover of protein derived from mammalian tissues into feeds which may be used for ruminants. 

As a result . the poultry meal you manufacture may contain protein derived from mammalian tissues prohibited in ruminant feed. Pursuant to 21 CFR 589.2000(e)(1)(i), any products containing or may contain protein derived from mammalian tissues must be labeled, "Do not feed to cattle or other ruminants." Since you failed to label a product which may contain protein derived from mammalian tissues with the required cautionary statement. the poultry meal is misbranded under Section 403(a)(1) [21 USC 343(a)(1)] of the Act. 

This letter is not intended as an all-inclusive list of violations at your facility. As a manufacturer of materials intended for animal feed use, you are responsible for ensuring your overall operation and the products you manufacture and distribute are in compliance with the law. You should take prompt action to correct these violations, and you should establish a system whereby violations do not recur. Failure to promptly correct these violations may result in regulatory action, such as seizure and/or injunction, without further notice. 

You should notify this office in writing within 15 working days of receiving this letter, outlining the specific steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating corrections have been made. 

Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S. Food and Drug Administration, 2424 Edenborn Avenue, Suite 410, Metairie, Louisiana 70001. If you have questions regarding any issue in this letter, please contact Mr. Rivero at (504) 219-8818, extension 103. 

Sincerely, 

/S 

Carol S. Sanchez
Acting District Director
New Orleans District 


http://www.fda.gov/foi/warning_letters/g5883d.htm 




AHH, with all the bad news about FDA et al on there lack of enforcement, I would have expected a token mad cow feed ban warning letter or two to pop up now. what would really be interesting would be to see all violations of the mad cow feed ban, large and small, from all states. ...tss

#################### https://lists.aegee.org/bse-l.html ####################




----- Original Message ----- 
From: Terry S. Singeltary Sr. 
To: Ken Silverman 
Sent: Thursday, September 15, 2005 12:56 PM
Subject: HOUND STUDY



GAH WELLS (very important statement here...TSS) 

HOUND STUDY 

AS implied in the Inset 25 we must not _ASSUME_ that 
transmission of BSE to other species will invariably 
present pathology typical of a scrapie-like disease. 

snip... 

http://www.bseinquiry.gov.uk/files/yb/1991/01/04004001.pdf 

76 pages on hound study; 

http://www.bseinquiry.gov.uk/files/sc/seac16/tab04.pdf

> I thought that in Britain dogs had contracted BSE, but perhaps not. 

not so fast here; 

The spongiform changes were not pathognomonic (ie. 
conclusive proof) for prion disease, as they were atypical, 
being largely present in white matter rather than grey matter in 
the brain and spinal cord. However, Tony Scott, then head of 
electron microscopy work on TSEs, had no doubt that these 
SAFs were genuine and that these hounds therefore must have 
had a scrapie-like disease. I reviewed all the sections 
myself (original notes appended) and although the pathology 
was not typical, I could not exclude the possibility that this was 
a scrapie-like disorder, as white matter vacuolation is seen 
in TSEs and Wallerian degeneration was also present in the 
white matter of the hounds, another feature of scrapie. 

38.I reviewed the literature on hound neuropathology, and 
discovered that micrographs and descriptive neuropathology from 
papers on 'hound ataxia' mirrored those in material from 
Robert Higgins' hound survey. Dr Tony Palmer (Cambridge) had 
done much of this work, and I obtained original sections 
from hound ataxia cases from him. This enabled me provisionally to 
conclude that Robert Higgins had in all probability detected 
hound ataxia, but also that hound ataxia itself was possibly a 
TSE. Gerald Wells confirmed in 'blind' examination of single 
restricted microscopic fields that there was no distinction 
between the white matter vacuolation present in BSE and 
scrapie cases, and that occurring in hound ataxia and the hound 
survey cases. 

39.Hound ataxia had reportedly been occurring since the 1930's, 
and a known risk factor for its development was the feeding 
to hounds of downer cows, and particularly bovine offal. 
Circumstantial evidence suggests that bovine offal may also be 
causal in FSE, and TME in mink. Despite the inconclusive 
nature of the neuropathology, it was clearly evident that this 
putative canine spongiform encephalopathy merited further 
investigation. 

40.The inconclusive results in hounds were never confirmed, 
nor was the link with hound ataxia pursued. I telephoned Robert 
Higgins six years after he first sent the slides to CVL. 
I was informed that despite his submitting a yearly report to the 
CVO including the suggestion that the hound work be continued, 
no further work had been done since 1991. This was 
surprising, to say the very least. 

41.The hound work could have provided valuable evidence 
that a scrapie-like agent may have been present in cattle offal long 
before the BSE epidemic was recognised. The MAFF hound 
survey remains unpublished. 

Histopathological support to various other published 
MAFF experiments 

42.These included neuropathological examination of material 
from experiments studying the attempted transmission of BSE to 
chickens and pigs (CVL 1991) and to mice (RVC 1994). 

http://www.bseinquiry.gov.uk/witness/htm/stat067.htm 

It was thought likely that at least some, and probably all, of the cases 
in zoo animals were caused by the BSE agent. Strong support for this 
hypothesis came from the findings of Bruce and others (1994) 
( Bruce, M.E., Chree, A., McConnell, I., Foster, J., Pearson, G. & 
Fraser, H. (1994) Transmission of bovine spongiform encephalopathy and 
scrapie to mice: strain variation and species barrier. Philosophical 
Transactions of the Royal Society B 343, 405-411: J/PTRSL/343/405 
), who demonstrated that the pattern of variation in incubation period 
and lesion profile in six strains of mice inoculated with brain 
homogenates from an affected kudu and the nyala, was similar to that 
seen when this panel of mouse strains was inoculated with brain from 
cattle with BSE. The affected zoo bovids were all from herds that were 
exposed to feeds that were likely to have contained contaminated 
ruminant-derived protein and the zoo felids had been exposed, if only 
occasionally in some cases, to tissues from cattle unfit for human 
consumption. 

snip... 

http://www.bseinquiry.gov.uk/files/ws/s324.pdf


2005


DEFRA
Department for Environment,
Food & Rural Affairs

Area 307, London, SW1P 4PQ
Telephone: 0207 904 6000
Direct line: 0207 904 6287
E-mail: h.mcdonagh.defra.gsi.gov.uk

GTN:
FAX:

Mr T S Singeltary
P.O. Box 42
Bacliff
Texas
USA 77518

21 November 2001

Dear Mr Singeltary TSE IN HOUNDS

Thank you for e-mail regarding the hounds survey. I am sorry for the long delay in responding.

As you note, the hound survey remains unpublished. However the Spongiform Encephalopathy Advisory Committee (SEAC), the UK Government's independent Advisory Committee on all aspects related to BSE-like disease, gave the hound study detailed consideration at their meeting in January 1994. As a summary of this meeting published in the BSE inquiry noted, the Committee were clearly concerned about the work that had been carried out, concluding that there had clearly been problems with it, particularly the control on the histology, and that it was more or less inconclusive. However was agreed that there should be a re-evaluation of the pathological material in the study.

Later, at their meeting in June 95, The Committee re-evaluated the hound study to see if any useful results could be gained from it. The Chairman concluded that there were varying opinions within the Committee on further work. It did not suggest any further transmission studies and thought that the lack of clinical data was a major weakness.

Overall, it is clear that SEAC had major concerns about the survey as conducted. As a result it is likely that the authors felt that it would not stand up to r~eer review and hence it was never published. As noted above, and in the detailed minutes of the SEAC meeting in June 95, SEAC considered whether additional work should be performed to examine dogs for evidence of TSE infection. Although the Committee had mixed views about the merits of conducting further work, the Chairman noted that when the Southwood Committee made their recommendation to complete an assessment of possible spongiform disease in dogs, no TSEs had been identified in other species and hence dogs were perceived as a high risk population and worthy of study. However subsequent to the original recommendation, made in 1990, a number of other species had been identified with TSE ( e.g. cats) so a study in hounds was less



critical. For more details see-
http://www.bseinquiry, gov.uk/files/yb/1995/06/21005001 .pdf

As this study remains unpublished, my understanding is that the ownership of the data essentially remains with the original researchers. Thus unfortunately, I am unable to help with your request to supply information on the hound survey directly. My only suggestion is that you contact one of the researchers originally involved in the project, such as Gerald Wells. He can be contacted at the following address.

Dr Gerald Wells, Veterinary Laboratories Agency, New Haw, Addlestone, Surrey, KT 15 3NB, UK

You may also wish to be aware that since November 1994 all suspected cases of spongiform encephalopathy in animals and poultry were made notifiable. Hence since that date there has been a requirement for vets to report any suspect SE in dogs for further investigation. To date there has never been positive identification of a TSE in a dog.

I hope this is helpful

Yours sincerely 4

HUGH MCDONAGH
BSE CORRESPONDENCE SECTION


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