Follow Ups | Post Followup | Back to Discussion Board | VegSource
See spam or
inappropriate posts?
Please let us know.

From: TSS ()
Subject: Animal by-products legislation PET FOODS AND TSEs (MAD CATS, DOGS AND PEOPLE) BUT GW WANTS TO EMPLEMENT HIS BSe MRR to trade TSEs globally
Date: March 2, 2005 at 9:43 am PST

-------- Original Message --------
Subject: Animal by-products legislation PET FOODS AND TSEs
Date: Tue, 1 Mar 2005 11:34:59 -0600
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy

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

Last update: February 1, 2005

Animal by-products legislation

European Parliament and Council regulation 1774/2002

establishes the health rules concerning animal by-products not intended
for human consumption and replaces Directive 90/667/EEC. This regulation
as well as the TSE regulation was
developed in response to the BSE crisis and is part of the EU's strategy
to eradicate food-borne crises. The animal by-products regulation covers
all animal products not intended for human consumption, and as such
covers both products for technical uses and animal by-products used in
the production of feeds and pet food. This regulation requires that
animal by-products used in the production of feeds and pet food be
derived from the carcasses of animal declared fit for human consumption
following veterinary inspection (category 3 products in the regulation).
Provisions include a ban on intra-species recycling and fallen stock and
restrictions on yellow grease. Certain categories of pet food have to be
denatured with specified substances. Pet food plants have to be
dedicated to production of product fit for human consumption.

EU rules on animal by-products set to apply for imports (European
Commission Press Release - May 3, 2004

Questions and Answers on animal by-products published by the Health &
Consumer Protection DG - May 6, 2004

Applying the new animal by-products regulation: guidance document
published by the Health & Consumer Protection DG - April 2004

Implementation of the animal by-products legislation, originally
scheduled for May 1, 2003, has been postponed several times. The
implementing regulation 668/2004

provides model health certificates for a large number of products
including pet foods. After June 15, 2004, APHIS will only issue new
certificates. Member states have been instructed to accept shipments
accompanied by the old certificates until August 15, 2004, provided the
shipment has left the U.S. before June 15, 2004 (Commission Regulation

Commission Regulation 780/2004

grants a further temporary derogation to the U.S. concerning the
separation of Category 1, 2 and 3 processing plants for a number of feed
ingredients and technical products. Categories are defined in articles
4, 5 and 6 of regulation 1774/2002. This derogation applies until
October 31, 2005. The model health certificates for all products covered
by the derogation are published in the annex to the regulation.
Commission Decision 2004/407/EC

(corrected version published in Official Journal L 208) grants a
derogation for the import of photographic gelatin from the U.S. intended
for the production of photo films in France, the Netherlands and the U.K.

Export certificates need to be obtained PRIOR to the shipment of the

For more information, please contact:

Animal Plant Health Inspection Service (APHIS)
Joyce Bowling-Heyward
Senior Staff Veterinarian
National Center for Import and Export
Veterinary Services
phone 301-734-3277
fax 301-734-8226

GAIN Report E23078

provides additional information to the full range of implementation
measures that were agreed.

Effects on U.S. exports:

Pet Food:
- pet food plants would have to be dedicated
- certain categories of pet food would have to be denatured with
specified substances
- there would be a ban on the use of fallen stock for pet food.

More information on pet food ...

Implementation of Regulation 1774/2002 requires major adjustments from
the U.S. industry and could have a negative impact on U.S. exports of
animal by-products not intended for human consumption to the EU. U.S.
exports of such products were valued around $465 million in CY 2001.

Pet Food

EU Pet food Legislation

All pet food imported from the U.S. into the European Union has to meet
requirements relating mainly to health and labeling aspects. These
requirements are generally harmonized throughout the 25 EU member states
but they are scattered over different pieces of EU legislation.

GAIN Report E23054

provides information on EU petfood regulations, labeling requirements
and certificates.

Current Requirements - Certificates, Ingredients, Labeling

Health Certificates and APHIS Establishment Inspection

A health certificate has to accompany each individual pet food shipment
containing product of animal origin. Following the implementation of the
EU animal by-products regulation 1774/2002
new certificates are in force since June 15, 2004. The animal health
and/or public health certificates signed by Animal and Plant Health
Inspection Service officials serve as a guarantee that individual lots
or shipments of products meet EU health requirements. Establishments
that wish to export to the EU have to request inspection of an APHIS
field office and get an
APHIS approval number for export to the EU. APHIS veterinary services
will endorse certificates after facilities have been officially approved
as compliant with animal by-products regulation 1774/2002
This approval number will also be put on the certificate. A statement
guaranteeing that SRMs (specified risk materials) have been removed
needs to be added to the certificate. As a number of issues related to
the implementation of regulation 1774/2002 are still unresolved,
exporters are advised to regularly check the APHIS website.

The APHIS website provides Specimen Health Certificates for:

- Animal by-products for the manufacture of pet food

- Digests for pet food flavoring

- Dog chews

- Pet food other than canned

- Canned pet food

Additional information can also be obtained from the APHIS headquarters:

National Center for Import and Export
Technical Trade Services
Animal Products Staff Import/Export Animals Staff
Tel: (301) 734 8364
Fax: (301) 734 8226

Guidelines for Petfood Exports to the EU
can be
downloaded from the APHIS website.

Petfood Ingredient Requirements

A. Authorized Ingredients and Additives

In the EU, there is no positive list of ingredients that can be used in
pet food. A positive list is however in place for additives and the
so-called technical proteins. An up-to-date consolidated version of the
list of authorized additives

was published in Official Journal C50 of February 25, 2004. This list
contains the additives approved in Directive 70/524/EEC

and all subsequent amendments and the technical proteins such as yeasts
that are authorized in the EU by Directive 82/471/EEC
Updates are available on DG Health & Consumer Protection's website

B. Prohibited Ingredients

Industrial Waste

Several ingredients are prohibited in feed. For a long time, several
types of industrial and household waste have been prohibited. These
ingredients are listed in Decision 2004/217/EC
and have not been an issue for the pet food industry.

Animal By-Products

European Parliament and Council Regulation 1774/2002

establishes the health rules concerning animal by-products not intended
for human consumption and replaces Directive 90/667/EEC. This regulation
as well as the TSE regulation was
developed in response to the BSE crisis and is part of the EU's strategy
to eradicate food-borne crises. The animal by-products regulation covers
all animal products not intended for human consumption, and as such
covers both products for technical uses and animal by-products used in
the production of feeds and pet food. This regulation requires that
animal by-products used in the production of feeds and pet food be
derived from the carcasses of animal declared fit for human consumption
following veterinary inspection (category 3 products in the regulation).
Provisions include a ban on intra-species recycling and fallen stock and
restrictions on yellow grease. Certain categories of pet food have to be
denatured with specified substances. Pet food plants have to be
dedicated to production of product fit for human consumption. More...

The following issues covered have practical consequences for the U.S.
petfood exports to the EU:

fit for human consumption: all ingredients used for the manufacture of
petfood have to be "fit for human consumption" according to EU
standards. Only animals declared healthy after ante- and post-mortem
examination will qualify as ingredients for petfood. Fallen stock is banned.

registration: pet food and rendering plants have to be registered by and
approved by the "third country competent authority", in this case APHIS,
as complying with EU requirements. EU requirements include regular
inspection by the competent authority, mandatory record keeping and
salmonella and enterobacteriacea testing. Only products from companies
on the approved establishments list will pass border control into the EU.

segregation: plants manufacturing and storing pet food are not allowed
to manufacture and store animal by-products that do not fulfill EU pet
food requirements.

raw pet food: has to be labeled "pet food only"

denaturing: raw material for the manufacture of pet food has to be
marked permanently by charcoal.

yellow grease: will be banned when the regulation is fully implemented.

Specified Risk Materials

U.S. Petfood certificates currently have to include a statement
certifying that SRMs (specified risk
materials) have been removed. The Commission has proposed to prolong
this transitional measure until July 2005. The two year extension is
designed for the Commission to continue its attempt to reach an
agreement at international level (OIE) on the determination of BSE
status of countries on the basis of risk. The decision on the final BSE
category will determine whether the U.S. will have to continue to remove
SRMs from pet food.

Petfood Labeling Requirements

General labeling requirements for pet food are established in Council
Directive 79/373/EEC
The EU directive on additives on feedingstuffs (Directive 70/524/EEC
lists all authorized additives and provides labeling requirements for
pet food containing additives (art. 16). The directive allows
multi-language labels but at the same time requires that the label be at
least in the language where the products is sold. In practice, countries
apply the following language requirements:

Austria: German
Belgium: Dutch AND French, German recommended
Czech Republic: Czech
Denmark: Danish
Estonia: Estonian
Finland: Finnish
France: French
Germany & Austria: German
Greece: Greek
Hungary: Hungarian
Italy: Italian
Latvia: Latvian
Lithuania: Lithuanian
Luxembourg: French OR German (or regional language Luxemburgian)
Malta: English OR Maltese OR Italian
Netherlands: Dutch
Poland: Polish
Portugal: Portuguese
Slovakia: Slovak
Slovenia: Slovene
Spain: Spanish
Sweden: Swedish
U.K. & Ireland: British English

For detailed information on pet food labeling requirements see GAIN
report E23054

(April 2003).

Other EU Requirements

Wooden pallets used to transport goods from the U.S. to the EU have to
comply with measures adopted by the EU requiring the treatment and
marking of all new and used coniferous mon-manufactured wood packing
material originating in the U.S., Canada, China and Japan to prevent the
introduction of pinewood nematode. Information on the programs developed
to comply with these measures is available from the APHIS website

Genetically Modified Feed

On April 18, 2004, the EU implemented the regulations on Genetically
Modified Food and Feed (European Parliament and Council Regulation
and Traceability and Labeling of Genetically Modified Organisms and the
Traceability of Food and Feed Products produced from Genetically
Modified Organisms (European Parliament and Council Regulation
These new regulations repeal three of the four regulations previously in
force: Regulation 1139/98 on the labeling of foodstuffs derived from
Round-Up Ready soybeans and Novartis Bt-176 corn, Regulation 49/2000 on
adventitious contamination and Regulation 50/2000 on genetically
modified additives and flavorings.

The new regulations set up an EU system to trace GMOs, introduce the
labeling of GM feed, reinforce the existing labeling rules for GM food
and establish an authorization procedure for GMOs in food and feed and
their deliberate release into the environment. Both regulations have
two-year review clauses, which require the Commission to report on their
implementation and make recommendations for changes, if appropriate.
Recommended changes must be approved by the Council and the European
Parliament. Commission Regulation 641/2004

lays down implementing rules for the authorization of GM food and feed
under Regulation 1829/2003. It clarifies what information and data have
to be provided to support applications for the authorization of new GM
food and feed and the notification of existing products.

For more information see our webpage on GMO's

Future Requirements: Proposals under Discussion

Traceabiltiy / Hygiene

Traceability for all food and feeds produced and imported in the
EU will be mandatory. For more information see our webpage on Food
Safety .

Info on Member State Requirements

The current EU legislation requirements apply in the 25 EU Member
States. However, member States may also demand that additional
requirements be met or may have their own requirements in areas where EU
harmonization has not been concluded yet. For example, by including fats
and gelatin, the French list of SRMs is more extensive than the EU
list. For Member State specific information, please contact our Offices
of Agricultural Affairs in the individual EU countries

Petfood Reports

- The Petfood Market in Italy

- Agexporter article "Frances Little Animal Kingdom"

Voluntary Report - public distribution
Date: 5/21/2003
GAIN Report Number: E23078
European Union
Sanitary/Phytosanitary/Food Safety
Animal By-product Rules Delayed
Approved by:
Norval E. Francis, Jr.
U.S. Mission to the European Union, Brussels
Prepared by:
Gerda Vandercammen
Report Highlights:
The new EU rules on third country imports of animal by-products have
been delayed from
May 1, 2003 until December 31, 2003.
Includes PSD Changes: No
Includes Trade Matrix: No
Unscheduled Report
Brussels USEU [BE2]
USDA Foreign Agricultural Service
GAIN Report
Global Agriculture Information Network
GAIN Report - E23078 Page 2 of 3
UNCLASSIFIED USDA Foreign Agricultural Service
On April 16, 2003, the EU Standing Committee on Food Safety and Animal
approved the transitional and permanent implementing measures concerning
the animal
by-products regulation (Reg. 1774/2002). Of particular importance to the
U.S. is the
approval of a transitional period for third countries providing for a
postponement of
certain portions of the regulation until December 31, 2003. The
transitional period is
needed to allow for the Commission to make technical amendments to the
certificates. Other measures adopted concern:
- the transitional measures on catering waste and used cooking oil for
and Austria
- the burial and burning of animal carcasses on the farm
- the derogation on the intra-species recycling ban for fish and fur animals
- the protection of endangered species
- composting and biogas standards
- manure processing
- the collection of wastewater
- treatment of mammalian blood
- separation standards in oleo-chemical plants, processing plants and
- the collection and disposal of former foodstuffs
All measures were published in Official Journal L 117 on May 13 and can be
downloaded from
a direct link to Commission Regulation 812/2003 granting a delay to
third countries.
GAIN Report - E23078 Page 3 of 3
UNCLASSIFIED USDA Foreign Agricultural Service
Background. In September 2002, the European Commission approved Regulation
1774/2002 that will require animal by-products not intended for human
(including blood products, hides and pet food) be derived from the
carcasses of animals
fit for human consumption. This regulation could negatively impact U.S.
exports of
animal by-products not intended for human consumption to the European
Union. U.S.
exports to the EU of these products were valued at $465 million in CY01.
The legislation
prohibits the use of any rendered protein which was obtained from animal
that were unfit for human consumption as an animal feed ingredient or
for pet food. For
example, fallen stock will not be permitted in feed.
Related USEU reports:
Report Number
Date released
Animal by-products: Fish Feed
EU Petfood Regulations 04/08/03
EU Annual Livestock Report
Visit our website: our website provides a
broad range of
useful information on EU import rules and food laws and allows easy
access to USEU reports,
trade information and other practical information. More information on
animal by-products
can be found at More
information on EU TSE
regulations is available from E-mail:


FOR IMMEDIATE RELEASE Statement May 26, 2003

Media Inquiries: 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA BSE Update - Pet Food from Canadian Manufacturer

The Food and Drug Administration (FDA) has learned from the government
of Canada that rendered material from a Canadian cow that last week
tested positive for bovine spongiform encephalopathy (BSE, also known
as mad cow disease) may have been used to manufacture pet food,
specifically dry dog food, some of which was reported to have been
shipped to the United States. The Canadian government prevented the BSE
positive cow from being processed for human food. Therefore, consumers
can be assured that their food does not contain any remnants of the BSE
positive cow.

It is also important to stress that there is no scientific evidence to
date that dogs can contract BSE or any similar disease. In addition
there is no evidence that dogs can transmit the disease to humans.

FDA notified the U.S. pet food firm, The Pet Pantry International, of
Carson City, Nevada, when FDA learned that the pet food that the firm
received may have included rendered material from the BSE positive cow.
The manufacturer of the pet food is Champion Pet Food, Morinville,
Alberta. Even though there is no known risk to dogs from eating this dog
food, as a prudent measure to help assure that the U.S. stays BSE free
The Pet Pantry International is asking its customers who may have
purchased the suspect product to hold it for pickup by the distributor
so that the dog food will not mistakenly be mixed into cattle or other
feeds if any of the dog food is discarded or otherwise not used to feed
dogs. The suspect dog food was produced by Champion Pet Food between
February 4, 2003, and March 12, 2003.

The Pet Pantry products were packaged in 50 lb bags, distributed to
franchises around the country, and sold by home delivery only. There was
no retail distribution of the product. Consumers purchase Pet Pantry
products by phone or email orders. The product is then delivered by the
nearest franchisee directly to the consumers home.

The product subject to this notification includes Maintenance Diet
labeled with a use by date of 17FEB04 and Beef with Barley with a
use by date of 05MAR04. Consumers who have purchased dog food from The
Pet Pantry since February of this year are asked to check their present
supplies and see if any match the description of the product being
removed. If so, consumers are asked to contact The Pet Pantry at
1-800-381-7387 for further information on how to return the product to
The Pet Pantry for proper disposal. Consumers are asked not to destroy
or discard the product themselves. The Pet Pantry will also use its
sales records to contact consumers who purchased the affected product.

FDA is working closely with the Pet Pantry International to assure for
proper disposal of the recovered product.

FDA will continue to provide updates on this case of BSE in Canada as
additional information becomes available.

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.


cases have been reported in domestic cats), are characterised by long
asymptomatic incubation periods followed by progressive symptoms and
signs of degeneration of the brain, leading eventually to death.


worse still, there is serious risk the media could get to hear of such a


Crushed heads (which inevitably involve brain and spinal cord material)
are used to a limited extent but will also form one of the constituent
raw materials of meat and bone meal, which is used extensively in pet
food manufacturer...

2. The Parliamentary Secretary said that he was concerned about the
possibility that countries in which BSE had not yet been detected could
be exporting raw meat materials (in particular crushed heads)
contaminated with the disease to the UK for use in petfood manufacture...


YOU explained that imported crushed heads were extensively used in the
petfood industry...

In particular I do not believe one can say that the levels of the
scrapie agent in pet food are so low that domestic animals are not

some 100+ _documented_ TSE cats of all types later...tss

on occassions, materials obtained from slaughterhouses will be derived
from sheep affected with scrapie or cattle that may be incubating BSE
for use in petfood manufacture...

Meldrum's notes on pet foods and materials used


Confidential BSE and __________________

1st case natural FSE

FSE and pharmaceuticals

confidential cats/dogs and unsatisfactory posture MAFFs failure to
assure key research

can't forget about the mad man and his mad cat;

Deaths of CJD man and cat linked

In October 1998 the simultaneous occurrence of spongiform encephalopathy
in a man and his pet cat was reported. The report from Italy noted that
the cat did not display the same clinical features as FSE cases
previously seen. Indeed, the presence of a new type of FSE was
suggested. The man was diagnosed as having sporadic CJD, and neither
case (man nor cat) appeared to be affected by a BSE-related condition.

indeed there have been 4 documented cases of TSE in Lions to date.

Lion 32 December 98 Born November 86

Lion 33 May 1999 (euthanased) Born November 81.

Lion 36 Euthanased August 2000 Born July 87. Deteriorating hind limb

Lion 37 Euthanased November 2001 Male, 14 years. Deteriorating hind limb
ataxia since September 2001. (Litter mate to Ref. 36.)

go to the url above, on the bar at the top, click on _statistics_, then
in middle of next page, click on _other TSEs_.

or go here;



Reports on the clinical symptoms presented by these cats give a
relatively homogeneous picture: Affected cats show a lack of
coordination with an ataxia mainly of the hind limbs, they often fall
and miss their target when jumping. Fear and increased aggressiveness
against the owner and also other animals is often seen. They do not
longer tolerate to be touched (stroked) and start hiding. These
behavioural chances might be the result of a hypersensibility to touch
and noise, but also to increased fear. Excessive salivation is another
more frequently seen symptom. Cats with FSE in general show severe
behavioural disturbances, restlessness and depression, and a lack of
coat cleaning. Symptoms in large cats in general are comparable to those
in domestic cats. A report on FSE (in german) has been presented in 2001
in the Swiss FVO Magazin. A paper on the first FSE case in a domestic
cat in Switzerland is currently in press in the Journal Schweizer Archiv
für Tierheilkunde (SAT).

17 Oct 2002 17:04:51 -0700 From: "Terry S. Singeltary Sr." Reply-To:
Bovine Spongiform Encephalopathy To: BSE-L

Greetings BSE-L,

is there any other CWD surveys/testing in the UK on their deer? what
sort of testing has been done to date on UK/EU deer? any input would be
helpful... thank you


hope they did not go by the wayside as the hound study;

37.Putative TSE in hounds - work started 1990 -(see para 41)

Robert Higgins, a Veterinary Investigation Officer at Thirsk, had been
working on a hound survey in 1990. Gerald Wells and I myself received
histological sections from this survey along with the accompanying
letter (YB90/11.28/1.1) dated November 1990. This letter details
spongiform changes found in brains from hunt hounds failing to keep up
with the rest of the pack, along with the results of SAF extractions
from fresh brain material from these same animals. SAFs were not found
in brains unless spongiform changes were also present. 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).

nothing to offer scientifically;

maddogs and Englishman

kind regards, terry

Fri, 18 Oct 2002 23:12:22 +0100 From: Steve Dealler Reply-To: Bovine
Spongiform Encephalopathy Organization: Netscape Online member To: BSE-L
References: <>

Dear Terry, An excellent piece of review as this literature is
desparately difficult to get back from Government sites.

What happened with the deer was that an association between deer meat
eating and sporadic CJD was found in about 1993. The evidence was not
great but did not disappear after several years of asking CJD cases what
they had eaten. I think that the work into deer disease largely stopped
because it was not helpful to the UK industry...and no specific cases
were reported. Well, if you dont look adequately like they are in USA
currenly then you wont find any!

Steve Dealler ===============

Incubation periods for BSE are proportional to the life expectancy of
the animal affected. The disease's incubation period is 18% of a cow's
life expectancy and would be expected to about double when crossing to
another species [---] that is, to 36% of 70 years in humans.

Steve Dealler, consultant in medical microbiology. Burnley General
Hospital, Burnley BB10 2PQ


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 [PART 1]

Docket Management Docket: 02N-0273 - Substances Prohibited From Use in
Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed Comment
Number: EC -11 Accepted - Volume 2 [PART 2]

FDA BSE Update - Pet Food from Canadian Manufacturer & MAD DOG DATA



August 22, 2003 5:11 PM

Mad cat disease

A second case of feline spongiform encephalopathy (FSE), a disease
affecting the brain tissue of cats, has been recorded in Switzerland.
The veterinary authorities said the likely cause of the infection, which
is similar to mad cow disease, was contaminated pet food. A first case
of FSE was reported two years ago. Experts say the disease poses no
health risk for people.


Pet Food In Ruminant Feed

Under the current regulation, pet food for retail sale is exempt from
the labeling requirement and need not bear the caution statement Do not
feed to cattle or other ruminants. However, if the pet food products
are sold or are intended for sale as distressed or salvage items, then,
under Section 589.2000(d)(4) in the Code of Federal Regulations, such
products must state, Do not feed to cattle or other ruminants. In
order to assure that salvaged pet food is not used in ruminant feed
despite the requirement that it be labeled with the caution statement,
the FDA is asking for comments on the following questions:

" Should pet food for retail sale be labeled with the statement Do not
feed to cattle or other ruminants?

" What would be the adverse and positive impacts (economic,
environmental, health, etc.) of such a labeling requirement?

Pet Foods

The FDA regulates that can of cat food, bag of dog food, or box of dog
treats or snacks in your pantry. The FDA's regulation of pet food is
similar to that for other animal feeds. The Federal Food, Drug, and
Cosmetic Act (FFDCA) requires that pet foods, like human foods, be pure
and wholesome, safe to eat, produced under sanitary conditions, contain
no harmful substances, and be truthfully labeled. In addition, canned
pet foods must be processed in conformance with the low acid canned food
regulations to ensure the pet food is free of viable microorganisms (see
Title 21 Code of Federal Regulations (CFR), Part 113).

There is no requirement that pet food products have premarket approval
by the FDA. However, FDA ensures that the ingredients used in pet food
are safe and have an appropriate function in the pet food. Many
ingredients such as meat, poultry, grains, and their byproducts are
considered safe foods and do not require premarket approval. Other
substances such as mineral and vitamin sources, colorings, flavorings,
and preservatives may be generally recognized as safe (GRAS) or must
have approval as food additives. (See Title 21 CFR, Parts 73, 74, 81,
573 and 582). For more information about pet foods and marketing a pet
food, see FDAs Regulation of Pet Food
Information on Marketing A Pet Food Product

Pet food labeling is regulated at two levels. The FDA regulations
require proper identification of the product, net quantity statement,
name and place of business of the manufacturer or distributor, and a
proper listing of all the ingredients in order from most to least, based
on weight. Some states also enforce their own labeling regulations. Many
of these regulations are based on a model provided by the Association of
American Feed Control Officials (AAFCO). For more information about
AAFCO , please visit its website. There are two
informational documents on CVMs web site that provide more details
about labeling requirements: Interpreting Pet Food Labels
and Interpreting
Pet Food Labels -- Special Use Foods

FDA also has put into place policies for making health claims on pet
food, such as maintains health of urinary tract, low magnesium,
reduces plaque and tartar, and reduces hairballs in cats. Guidance
for collecting data to make a urinary tract health claim is available in
Guideline 55 on the
CVM internet site.

BSE and the safety of pets

With the exception of cats, no pets (companion animals) are known to be
susceptible to the infectious agent that causes BSE in cattle. No
evidence of BSE has ever been found in dogs, horses, birds, or reptiles.

However, cats are susceptible. Approximately 90 cats in the UK and
several cats in other European countries have been diagnosed with the
feline version of BSE, or FSE. Before it was recognized that they were
susceptible to the BSE agent, cats were exposed to the infectious agent
through commercial cat food or through meat scraps provided by butchers.
The number of reported cases of FSE in the UK and Europe has been
declining annually since 1994 after implementation of feed bans in those

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.

Material from the BSE positive cow in Washington State did not pose a
risk to cats in the U.S. because none of it was released into
distribution. All firms involved with the incident in Washington State
were found to be in compliance with the BSE rules.

In addition, when the BSE positive cow was found in Canada in May 2003,
the FDA stopped imports of all pet foods made from material derived from
mammalian sources, and the pet food manufacturer recalled the food it
had manufactured that was thought to contain material from the infected

In an Advance Notice of Proposed Rulemaking published in the Federal
Register on July 14, 2004
, the FDA announced
that the agency intends to further strengthen the ruminant feed rule (or
BSE feed regulation) by prohibiting the use of high-risk tissues, often
referred to as specified risk material or SRM, in any animal feed
including pet food.

CVM DOES NOT recommend one product over another or offer guidance on
individual pet health issues that are normally provided by the pets
veterinarian. Questions regarding your pets' health and/or the specific
use of any veterinary drug, pet food, or other product should always be
referred to your veterinarian.

The following documents contain information on the regulation, marketing
and labeling of pet foods in the United States.

News Releases


CVM Update - FDA Issues Final Guidance on Raw Meat for Animals
, May 20, 2004


CVM Update - Alert to Pet Owners - Recall of Petcurean Go! Natural
Pet Food ,
November 3, 2003


Recall -- Firm Press Release - Voluntary Recall of Petcurean GO!
NATURAL Pet Food Consumers Asked to Return Product to Store
October 22, 2003


FDA Statement ­- FDA BSE Update - Pet Food from Canadian
r, May 26,


FDA Talk Paper - FDA Issues Safety Guidance on the Use of Raw Meat
for Pet Diets
December 18, 2002


FDA Talk Paper - Irradiation of Animal Feed
, April
10, 2001


New Pet Food Specialist at CVM
, January 5, 2001


HHS NEWS - FDA Issues Nationwide Public Health Advisory About
Contaminated Pet Chews
, October 1,
1999, October 1, 1999


Canadians Issue Warning About Dog Treats
, September
30, 1999

Guidance Documents


Guidance for Industry #122 - Manufacture and Labeling of Raw Meat
Foods for Companion and Captive Noncompanion Carnivores and
Omnivores, May 18, 2004, revised November 9, 2004 | doc
| | pdf

Federal Register Notices


Docket No. 2002D-0468, CVM 200439. Guidance for Industry on the
Manufacture and Labeling of Raw Meat Foods for Companion and
Captive Noncompanion Carnivores and Omnivores; Availability. Page
29140 [FR Doc. 04-11366] May 20, 2004 | htm
| | pdf
| Comments
due May 20, 2005


Docket No. 02N-0277, CFSAN 2003237. Establishment and Maintenance
of Records Under the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002. Pages 25187--25240 May 9,
20003 [FR Doc. 03-11460 ] Comments July 8, 2003 Comments July 8,
2003 - | htm
| | pdf |


Docket No. 02N-0275, CFSAN 2003239. Administrative Detention of
Food for Human or Animal Consumption Under the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002.
Pages 25241--25271 May 9, 2003 [FR Doc. 03-11459] Comments July 8,
2003 - | htm
| | pdf |


Docket No. 02N-0276, CFSAN 200236. Registration of Food Facilities
Under the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002. Proposed Rule, Pages 5377--5428 [FR Doc.
03-2443] Comments April 4, 2003 - Appendix
htm | | pdf


Docket No. 02N-0278, CFSAN 200238. Prior Notice of Imported Food
Under the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002. Proposed Rule, Pages 5428--5468 [FR Doc.
03-2444] Comments April 4, 2003 | htm
| | pdf


Docket No. 02D-0468, CVM 200251. Draft Guidance for Industry on
Manufacture and Labeling of Raw Meat Foods for Companion and
Captive Noncompanion Carnivores and Omnivores
; Availability.
Pages 77500--77501 [FR Doc. 02-31721] December 18, 2002 | htm
| | pdf
| Comments
March 3, 2003


Docket No. 99F-2799, CVM 2000108. Irradiation in the Production,
Processing, and Handling of Animal Feed and Pet Food; Irradiation.
Pages 18539-18540 [FR Doc. 01-088719] April 10, 2001 | htm
| | pdf

Information for Consumers


Pet Food: The Lowdown on Labels
Consumer, May/June 2001


FDAs Regulation of Pet Foods
, March 2000


Information on Marketing a Pet Food Product
, March 1999


Interpreting Pet Food Labels
, June 1999


Interpreting Pet Food Labels -- Special Use Foods
, June 1999


Vegetarian Diets For Pets?
FDA Veterinarian, May/June 1999


Selecting Nutritious Pet Foods
, November 1997

Other Information


FDA Import Alert 99-25 supports the APHIS import restrictions. We
refer you to FDA's Import Alert #99-25, "Detention without
Physical Examination of Animal Feed, Animal Feed Ingredients and
Other Products for Animal Use Consisting or Containing Ingredients
of Animal Origin
dated 6/12/02


Food and Drug Administration/Center for Veterinary Medicine -
Report on the risk from pentobarbital in dog food.
| html | | pdf
| | | doc

Additional Links


CVM and Bovine Spongiform Encephalopathy (BSE)

Web page updated by mdt
, January 27, 2005,
8:20 AM ET


######### ##########

Follow Ups:

Post a Followup

E-mail: (optional)


Optional Link URL:
Link Title:
Optional Image URL: