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From: TSS ()
Subject: Re: Gov't confirms dead cow in Hokkaido as 21st case of BSE
Date: December 12, 2005 at 8:01 am PST

Release No. 0546.05
Contact:
Suzan Holl (301) 734 6464
Jerry Redding (202) 720 6959

Printable version
USDA AMENDS REGULATIONS GOVERNING THE IMPORTATION OF WHOLE CUTS OF BONELESS BEEF FROM JAPAN

Questions and Answers: The Importation of Boneless Beef from Japan

WASHINGTON, Dec. 12, 2005- The U.S. Department of Agriculture's Animal and Plant Health Inspection Service today announced that it is amending regulations governing the importation of meat and other edible animal products to reestablish, under certain conditions, the importation of whole cuts of boneless beef from Japan. This final rule will continue to safeguard the United States against the introduction of bovine spongiform encephalopathy (BSE).

In September 2001, APHIS prohibited the importation of ruminants and most ruminant products from Japan following the confirmation of BSE in a native-born cow in that country. Recently, Japan requested that APHIS consider resuming the importation of beef from Japan to the United States. In a Federal Register notice published Aug. 18, 2005, APHIS proposed to amend the import regulations by allowing the importation of whole cuts of boneless beef from Japan under specified conditions. The regulations will be amended under this final rule.

After conducting a thorough risk analysis, APHIS has determined that such beef can be safely imported to the United States from Japan under the following conditions:

* The beef is prepared in an establishment that is eligible to have its products imported to the United States under the Federal Meat Inspection Act. This includes provisions that specified-risk materials (SRMs) must be removed under appropriate conditions and it also prohibits the use of air-injection stunning devices.
* The beef must be derived from cattle that are not subjected to a pithing process at slaughter.
* The mitigation measures must be certified on an original certificate issued by an authorized veterinary official of the Japanese government.

Research has demonstrated that only a limited number of tissues from cattle may harbor infectious levels of BSE. These are primarily the central nervous system tissues, such as the brain and spinal cord. Requirements for the removal of these tissues, commonly referred to as SRMs, would prevent them from entering the human food supply and are an important safeguard to protect public health. Research has not demonstrated that bovine muscle meat, which would be the sole product eligible for importation under the final rule, harbors BSE. The import conditions in the final rule including the removal of SRMs, are based on scientific research and in combination allow for the safe importation of whole cuts of boneless beef from Japan.

This final rule is scheduled for publication in the Dec. 14, 2005 Federal Register and becomes effective at 11:30 a.m. EST on Dec. 12, 2005.


http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB/.cmd/ad/.ar/sa.retrievecontent/.c/6_2_1UH/.ce/7_2_5JM/.p/5_2_4TQ/.d/2/_th/J_2_9D/_s.7_0_A/7_0_1OB?PC_7_2_5JM_contentid=2005%2F12%2F0546.xml&PC_7_2_5JM_navtype=RT&PC_7_2_5JM_parentnav=LATEST_RELEASES&PC_7_2_5JM_navid=NEWS_RELEASE#7_2_5JM


Release No. 0545.05
Contact:
USDA Press Office (202) 720-4623

Printable version
AUDIO: AGRICULTURE SECRETARY MIKE JOHANNS REMARKS REGARDING RESUMPTION OF BEEF TRADE WITH JAPAN

USDA_1 MP3

* ACTUALITY: JAPANESE CONSUMERS TO SOON ENJOY U.S. BEEF 00:00:34 - Secretary of Agriculture Mike Johanns saying that Japanese consumers will soon enjoy U.S. beef.

USDA_2 MP3

* ACTUALITY: U.S. WILL BEGIN IMPORTING KOBE BEEF SOON 00:00:53 - Agriculture Secretary Mike Johanns announcing U.S. will accept Kobe beef soon.

USDA_3 MP3

* ACTUALITY: U.S. TO BEGIN EXPORTING BEEF TO JAPAN 00:00:18 -Secretary of Agriculture Mike Johanns makes announcement that U.S. will begin exporting U.S. beef almost immediately.

USDA_4 MP3

* ACTUALITY: U.S. TO ACCEPT KOBE BEEF 00:01:02 - Agriculture Secretary Mike Johanns saying U.S. will be able to supply enough beef.


http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB/.cmd/ad/.ar/sa.retrievecontent/.c/6_2_1UH/.ce/7_2_5JM/.p/5_2_4TQ/.d/2/_th/J_2_9D/_s.7_0_A/7_0_1OB?PC_7_2_5JM_contentid=2005%2F12%2F0545.xml&PC_7_2_5JM_navtype=RT&PC_7_2_5JM_parentnav=LATEST_RELEASES&PC_7_2_5JM_navid=NEWS_RELEASE#7_2_5JM


Release No. 0544.05
Contact:
USDA Press Office (202) 720-4623

Printable version
STATEMENT BY AGRICULTURE SECRETARY MIKE JOHANNS REGARDING THE OPENING OF THE JAPANESE MARKET TO U.S. BEEF

Clarification noted in bold 3rd paragraph and last paragraph, number of countries

December 11, 2005

"I'm very pleased to announce that the Japanese market is now open to U.S. beef products. Resuming beef trade with Japan is great news for American producers and Japanese consumers, as well as an important step toward normalized trade based on scientifically sound, internationally recognized standards.

"Reopening the Japanese market to U.S. beef has been a top priority for me since becoming Secretary, and I want to thank the many people and organizations who have been instrumental in this success. First and foremost, my thanks to President Bush for being personally and directly engaged in this effort. I want to thank my colleagues in the President's cabinet, Secretaries Rice, Snow, Gutierrez and Ambassador Portman, as well as Ambassadors Baker and Schieffer, for making this issue a centerpiece of their discussions with Japan. I also extend my thanks to Chairmen Goodlatte and Chambliss, the entire American meat industry, and all of the USDA staff involved with the many meetings, site visits, reports and other consultations with Japan's food safety officials to confirm the safety of U.S. beef.

"Japan's action today provides sets an excellent example for other countries in Asia whose markets remain closed. Now is the time for Taiwan, South Korea, Hong Kong, China, Singapore and others to open their markets to U.S. beef. I urge all countries to take a science-based approach and adopt OIE standards for allowing beef trade. Building bridges of understanding and collaboration between nations is an important part of ensuring food safety. American producers are proud of our safe, high-quality beef products and we greatly value the opportunity to promote the safety of our products to consumers in Japan and around the world. As I have said many times throughout this process, our goal is the resumption of normal beef trade throughout the world and we will continue to aggressively work toward that objective."

Under the agreement announced today, the United States is able to export beef from cattle 20 months of age and younger to Japan. More than 94 percent of total U.S. ruminant and ruminant products, with a total export value of $1.7 billion in 2003, are now eligible for export to Japan. In 2003, the United States exported $1.4 billion worth of beef and beef products to Japan. Prior to the December 2003 discovery of the first BSE-infected cow in the United States, the U.S. exported beef and beef products to 119 countries. With the opening of Japan, 67 countries have now established trade to at least selected U.S. beef and beef products.

http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB/.cmd/ad/.ar/sa.retrievecontent/.c/6_2_1UH/.ce/7_2_5JM/.p/5_2_4TQ/.d/2/_th/J_2_9D/_s.7_0_A/7_0_1OB?PC_7_2_5JM_contentid=2005%2F12%2F0544.xml&PC_7_2_5JM_navtype=RT&PC_7_2_5JM_parentnav=LATEST_RELEASES&PC_7_2_5JM_navid=NEWS_RELEASE#7_2_5JM


JAPANESE BORDER OPENS TO CANADIAN BEEF

OTTAWA, December 11, 2005 – The Canadian Food Inspection Agency (CFIA) today announced that Japan has agreed to reopen its border to Canadian beef and selected beef products from cattle aged 20 months and younger.

The restoration of trade with Japan is the product of over two years of extensive engagement at all levels of government, including technical discussions, information sharing and industry endorsement. During this period, Canadian food safety, public and animal health experts presented detailed reports of Canada's response to mitigate bovine spongiform encephalopathy (BSE) risks. Japanese officials visited Canadian feed lots, farms, feed mills and slaughter facilities to observe these safeguards at work.

Japan was one of a number of countries that closed their borders to Canadian beef after the 2003 detection of BSE in Canada. Prior to suspending trade, Japan was the third largest importer of Canadian beef and beef products. Canada exported more than $81 million worth of product to Japan in 2002. Canada's top two importers, the United States and Mexico, reopened their borders to a range of products in 2003.

Regaining access to Japan marks a significant milestone in Canada's ongoing efforts to fully restore trade to pre-BSE levels. Canadian officials will continue to work closely with their counterparts in Japan and other international markets to demonstrate the scope and effectiveness of safeguards in place to protect human and animal health as the basis for expanded safe trade opportunities. These efforts will pursue access for all commodities deemed eligible for export in accordance with the science-based standards of the World Organization for Animal Health.

In addition to meeting the age requirement, beef products destined for Japan must be processed in accordance with a range of conditions. Additional details are available through regional CFIA offices.

- 30 -

For information:

Canadian Food Inspection Agency
Media Relations: (613) 228-6682

http://www.inspection.gc.ca/english/corpaffr/newcom/2005/20051211e.shtml

BSE import policy for bovine animals and their products

APHD-DSAE-IE-2005-9-1
Printer-friendly PDF Version

December, 2005

Main Page - BSE
1. Bovine animals

For the purpose of this policy, bovine animals consist of cattle and bison. Taxonomically they are classified as members of the Subfamily Bovinae1 from the genus Bos, which includes cattle (Bos taurus and Bos indicus) and bison (Bos bison).
2. Importing commodities into Canada

Depending on the nature of the commodity, certain BSE related restrictions may be applicable. Those commodities listed in section 3 may be generally imported into or transit Canada regardless of the BSE status of a country while commodities listed in sections 4 and 5 may be subjected to certain restrictions depending on the BSE status of the country, which is determined on the basis of a risk assessment as detailed in Appendix 1. However, before undertaking a risk assessment for a particular country it is important to determine the range of commodities for which a country is seeking market access. In many cases it is likely that a risk assessment will not be required. For example, if a country that has reported BSE cases within the preceding seven years is interested in just exporting meat and meat products, cell lines and veterinary biologics to Canada, a risk assessment would not be necessary as the measures for these commodities are the same regardless of whether it would be classified as Category 2 (controlled BSE-risk) or Category 3 (undetermined BSE-risk). On the other hand, a risk assessment would be required before a country, that has not reported BSE, could export these commodities without BSE related restrictions to determine if it qualifies for Category 1 (negligible BSE-risk).

If a risk assessment has not been undertaken for a particular country the applicable measures are those prescribed for countries as having an undetermined BSE-risk (Category 3). It is important to note that before a particular commodity can be imported other conditions must still be met. For example, before meat and meat products can be imported, the Canadian Food inspection Agency (CFIA) must evaluate and approve the meat inspection system of a country and specific measures for other diseases of concern must also be met. In addition, there may be other restrictions impacting on the end use of the product within Canada, for example, restrictions governing the end use of bovine blood and blood products in the preparation of drugs (including pharmaceuticals, and natural health care products), which are under the mandate of Health Canada. It is the responsibility of the importer to ensure compliance with the specific requirements of the Canadian regulatory authority responsible for the end use of imported products.

Table 1 summarises the list of commodities covered by this import policy in sections 3-5 and their associated BSE-related restrictions detailed in section 6. Commodities not included in this table will be assessed on a case by case basis taking into account the nature of the product, the methods of production and proposed use with applicable conditions developed on the basis of a risk assessment.

In developing measures necessary to protect human or animal life or health World Trade Organization Members have certain rights and obligations, which are detailed in the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) as well as the SPS provisions of the North American Free Trade Agreement (NAFTA). One important obligation relates to the concept of equivalence, which is the capability of different sanitary measures to achieve the same outcome. In applying this policy, provided a trading partner can objectively demonstrate that its measures achieve the same level of protection as those required by Canada, it is the Government of Canada’s intention that the trading partner’s measures be accepted as equivalent.

Table 1: BSE-related restrictions for certain commodities derived from bovine animals or containing material of bovine origin. Note that this table provides a general summary. For a complete description of the applicable conditions refer to the relevant section in the text.
Commodity Category 1 country
(negligible BSE-risk) Category 2 country
(controlled BSE-risk) Category 3 country
(undetermined BSE-risk)
a) milk and milk products

b) semen and in vivo derived bovine embryos

c) hides and skins

d) gelatin and collagen prepared exclusively from hides and skins (excluding hides and skins from the head)

e) protein-free tallow (maximum level of insoluble impurities of 0.15% in weight) and derivatives made from this tallow;

f) dicalcium phosphate (with no trace of protein or fat)

g) deboned skeletal muscle meat (excluding mechanically separated meat) from bovine animals 30 months of age or less, which were not subjected to a stunning process, prior to slaughter, with a device injecting compressed air or gas into the cranial cavity, or to a pithing process, and which were subject to ante-mortem and post-mortem inspections and were not suspect or confirmed BSE cases, and which has been prepared in a manner to avoid contamination with SRM

h) blood and blood by-products, from bovine animals which were not subjected to a stunning process, prior to slaughter, with a device injecting compressed air or gas into the cranial cavity, or to a pithing process, and which were subject to ante-mortem and post-mortem inspections and were not suspect or confirmed BSE cases, and which has been prepared in a manner to avoid contamination with SRM
no BSE restrictions related to country status no BSE restrictions related to country status no BSE restrictions related to country status
i) live animals; Permanent ID; born after a feed ban; etc. Prohibited
j) ruminant derived meat-and-bone meal or greaves, or any commodities containing such products Prohibited
k) meat and meat products other than deboned skeletal muscle meat as defined in (g) air injection stunning and pithing prohibited; SRM excluded
l) gelatin and collagen prepared from bones not prepared from SRM; subjected to certain processing steps
m) tallow (non protein-free) air injection stunning and pithing prohibited; not prepared from SRM Prohibited
n) tallow derivatives made from non protein free tallow air injection stunning and pithing prohibited; SRM excluded; produced by hydrolysis, saponification or transesterification using high temperature and pressure
o) dicalcium phosphate containing protein or fat air injection stunning and pithing prohibited; not prepared from SRM Prohibited
p) products produced by subjecting bones to rigorous processes of extraction and purification such as ossein, bone ash, bone charcoal and bone oil no BSE restrictions related to country status not prepared from SRM
q) products and by-products that have been subjected to rigorous processes of extraction and purification such as animal glue, oleosterin, triglycerides, glycerol, sorbitan esters not prepared from SRM
r) commercially prepared pet food and finished pet chews, such as dried processed ears, pizzles, hooves or tendons not prepared from SRM
s) cell lines Not prepared from SRM imported from a Category 2 or 3 country air injection stunning and pithing prohibited; not prepared from SRM
t) veterinary biologics
3. Commodities that can be imported into or transit Canada regardless of the BSE status of an exporting country

The following commodities derived from bovine animals can be imported into or transit Canada regardless of the BSE status of an exporting country:

* milk and milk products;
* semen and in vivo derived bovine embryos collected and handled in accordance with the recommendations of the International Embryo Transfer Society;
* hides and skins;
* gelatin and collagen prepared exclusively from hides and skins (excluding hides and skins from the head);
* protein-free tallow (maximum level of insoluble impurities of 0.15% in weight) and derivatives made from this tallow2;
* dicalcium phosphate (with no trace of protein or fat)2;
* deboned skeletal muscle meat (excluding mechanically separated meat) from bovine animals 30 months of age or less, which were not subjected to a stunning process, prior to slaughter, with a device injecting compressed air or gas into the cranial cavity, or to a pithing process, and which were subject to ante-mortem and post-mortem inspections and were not suspect or confirmed BSE cases, and which has been prepared in a manner to avoid contamination with SRM;
* blood and blood by-products, from bovine animals which were not subjected to a stunning process, prior to slaughter, with a device injecting compressed air or gas into the cranial cavity, or to a pithing process, or to a pithing process, and which were subject to ante-mortem and post-mortem inspections and were not suspect or confirmed BSE cases, and which has been prepared in a manner to avoid contamination with SRM.

4. Commodities prohibited from importation into Canada

Ruminant derived meat-and-bone meal or greaves, or any commodities containing such products are specifically prohibited from importation into Canada unless a risk assessment has been undertaken and the country is classified as Category 1 (negligible BSE-risk).

An exemption from this prohibition may be considered on a case-by-case basis if the materials used in the production of ruminant derived meat-and-bone meal or greaves, or any commodities containing such products have undergone a treatment or process to eliminate the BSE-agent equivalent to that applied in Canada. Details of the treatment or process deemed to be equivalent together with supporting data and references as appropriate should be provided to CFIA for approval.
5. Commodities that can be imported into or transit Canada subject to certain BSE-related measures

The following commodities derived from bovine animals or containing material of bovine origin are subject to certain BSE-related measures before they can be imported into or transit Canada:

* live animals;
* meat and meat products other than deboned skeletal muscle meat as defined in section 3 (g);
* gelatin and collagen prepared from bones intended for food, animal food, fertilisers, veterinary biologics, or as unprocessed material for the preparation of cosmetics, drugs (including pharmaceuticals and natural health products) or medical devices;
* tallow and tallow derivatives, and dicalcium phosphate, other than protein-free tallow and dicalcium phosphate (with no trace of protein or fat) as defined in section 3 (e) intended for food, animal food, fertilisers, veterinary biologics, or as unprocessed material for the preparation of cosmetics, drugs (including pharmaceuticals and natural health products) or medical devices;
* Products derived from bovine animals by subjecting bones to rigorous processes of extraction and purification such as ossein, bone ash, bone charcoal and bone oil and intended for food, animal food, fertilisers, or as unprocessed material for the preparation of cosmetics, drugs (including pharmaceuticals and natural health products), medical devices or veterinary biologics;
* Products and by-products derived from bovine animals that have been subjected to rigorous processes of extraction and purification such as animal glue, oleosterin, triglycerides, glycerol, sorbitan esters and intended for food, animal food, fertilisers, or as unprocessed material for the preparation of cosmetics, drugs (including pharmaceuticals and natural health products), medical devices or veterinary biologics;
* Commercially prepared pet food and finished pet chews, such as dried processed ears, pizzles, hooves or tendons;
* cell lines;
* veterinary biologics (vaccines, antibody products and diagnostic kits).

The types of measures that are applicable are dependant on the BSE-risk category of the exporting country, which is determined by a risk assessment as outlined in Appendix 1. The relevant measures are set down in section 6 for each of the three BSE-risk categories:

* Category 1. negligible BSE-risk
* Category 2. controlled BSE-risk
* Category 3. undetermined BSE-risk

If a risk assessment has not been undertaken for a particular country the applicable measures are those prescribed for a category 3 country (undetermined BSE-risk). Commodities not included in this section will be assessed on a case by case basis taking into account the nature of the product, the methods of production and proposed end use with applicable conditions developed on the basis of a risk assessment.
6. Risk management measures
6.1. Category 1 Countries (negligible BSE-risk)

6.1.1. Definition

Category 1 countries are those countries that:

*

a) have never reported a BSE-case, and where,
either:

the conclusion of risk assessment is that the likelihood that BSE exists in the country is negligible,

or where:

the conclusion of the risk assessment indicates that the likelihood of the bovine animal population having been exposed to a TSE-agent within the last 7 years is negligible and that the level of surveillance maintained during at least the last 7 years should have detected BSE cases if they were present.

Or:

*

b) have not reported BSE-cases in imported and/or indigenous animals for a period of at least seven years and have satisfied each of the following conditions throughout the same period:
o the likelihood of imported commodities being contaminated or infected with a TSE-agent has remained negligible;
o the likelihood of bovine animals having been exposed to a TSE that exists in the country’s domestic or wild ruminant population has remained negligible;
o the measures to eradicate BSE have been maintained;
o a level of surveillance capable of demonstrating the effectiveness of the eradication measures has been maintained without the detection of any BSE-cases.

The risk assessment for a country in this category must be reviewed regularly to ensure that it continues to qualify as a Category 1 country.

6.1.2. General provisions

* BSE is compulsorily notifiable.
* The Veterinary Administration has authority over any animal suspected or confirmed of having BSE. This is needed to ensure that a thorough investigation is undertaken and that affected animals, when slaughtered or at death, are completely destroyed.

6.1.3. Cell lines and Veterinary biologics (vaccines, antibody products and diagnostic kits) containing material of bovine origin intended for use in animals

Considering that cell lines and veterinary biologics often contain ingredients from a variety of sources, some of which may have been imported into the country, it is important to ensure that such ingredients do not contain or are not contaminated with the BSE-agent. As a result, certification is required for all cell lines and veterinary biologics that they do not contain any imported ingredients from a country classified as Category 2 (controlled BSE-risk) or Category 3 (undetermined BSE-risk) that may have been:

* prepared from bovine animals subjected to a stunning process, prior to slaughter, with a device injecting compressed air or gas into the cranial cavity or to a pithing process (laceration, after stunning, of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity), or;
* prepared from or contain the following specified risk materials (SRM):
o the skull including the brain, trigeminal ganglia and eyes, the spinal cord and the vertebral column excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum from all bovine animals aged 30 months or older;
o the small intestine and tonsils from bovine animals of all ages;
o the determination of the age of animals, stunning, dressing and removal, handling and disposition of SRM as inedible material meets the standards prescribed in the Government of Canada’s Meat Hygiene Directive.

An exemption from this requirement for cell lines and veterinary biologics will be considered on a case-by-case basis considering the nature of the product, the source of materials of bovine origin, the manufacturing methods employed, and the intended use.

6.1.4. Commodities other than cell lines and Veterinary biologics

While specific measures for BSE are not necessary for all other commodities derived from bovine animals, before a particular commodity can be imported other relevant conditions must still be met, for example, the evaluation and approval of the meat inspection system of a country and specific measures for other diseases of concern.
6.2. Category 2 Countries (controlled BSE-risk)

6.2.1. Definition

Category 2 countries are those countries where:

* it is likely that imported commodities were contaminated or infected with a TSE-agent, and/or;
* it is likely that a TSE exists in the country’s domestic or wild ruminant population, and;
* either indigenous BSE-cases have been reported, or it is likely that indigenous bovine animals have been exposed to a TSE-agent, and;
* the measures in place are effectively controlling BSE and are likely to lead to its eradication.

The risk assessment for a country in this category must be reviewed regularly to ensure that it continues to qualify as a Category 2 country.

6.2.2. General provisions

* The feeding of ruminants with meat-and-bone meal and greaves derived from ruminants has been banned and the ban has been effectively enforced in the whole country;
* BSE is compulsorily notifiable;
* The Veterinary Administration has authority over any animal suspected or confirmed of having BSE. This is needed to ensure that a thorough investigation is undertaken and that affected animals, when slaughtered or at death, are completely destroyed.

6.2.3. Live bovine animals

Certification by the Veterinary Administration that the animal:

* is identified by a permanent identification system enabling it to be traced back to its dam and herd of origin;
* was born after the implementation of the feed ban;
* was not fed ruminant proteins prohibited under the feed ban during its lifetime;
* is not the progeny of a BSE suspect or confirmed female;
* was not reared during its first year of life with a BSE suspect or confirmed case;
* was not born in the same herd and within 12 months of the birth of a BSE suspect or confirmed case.

An exemption from these requirements for live bovine animals will be considered on a case-by-case basis considering the intended use of the animals, for example, animals imported for a temporary stay; animals for immediate slaughter; animals imported for medical use, scientific research or zoological collections; bulls destined for semen production centers.

6.2.4. Meat and meat products from bovine animals other than deboned skeletal muscle meat as defined in section 3 (g)

Certification by the Veterinary Administration that:

* ante-mortem and post-mortem inspection is carried out on all bovine animals from which the meat or meat products originate;
* where the meat or meat products are destined for human consumption they have been passed as fit for human consumption in the country of origin;
* the facility in which the animals are slaughtered and processed is approved and inspected by the Veterinary Administration;
* the animals from which the meat or meat products destined for export originate were not subjected to a stunning process, prior to slaughter, with a device injecting; compressed air or gas into the cranial cavity or to a pithing process (laceration, after stunning, of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity);
* the meat and meat products destined for export do not contain:
o the following specified risk materials (SRM):
+ the skull including the brain, trigeminal ganglia and eyes, the spinal cord and the vertebral column, excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum, from all bovine animals aged 30 months or older;
+ the small intestine and tonsils from bovine animals of all ages;
o mechanically separated meat from the skull and vertebral column from animals aged 30 months or older;
* the determination of the age of animals, stunning, dressing and removal, handling and disposition of SRM as inedible material meets the standards prescribed in the Government of Canada’s Meat Hygiene Directive.

6.2.5. Gelatin and collagen prepared from the bones of bovine animals and intended for food, animal food, fertilisers, or as unprocessed material for the preparation of cosmetics, drugs (including pharmaceuticals and natural health products), medical devices or veterinary biologics

Certification by the Veterinary Administration that the bones:

* do not include skulls and vertebrae (excluding the vertebrae of the tail) from all animals aged 30 months or older;
* have been subjected to a process which includes all the following steps:
o pressure washing (degreasing);
o acid demineralisation;
o prolonged alkaline treatment;
o filtration;
o sterilisation at >138°C for a minimum of 4 seconds;
o or, to an equivalent process in terms of infectivity reduction3.

6.2.6. Tallow (other than protein-free tallow as defined in section 3) and dicalcium phosphate (other than protein or fat free dicalcium phosphate as defined in section 3) derived from bovine animals and intended for food, animal food, fertilisers, or as unprocessed material for the preparation of cosmetics, drugs (including pharmaceuticals and natural health products), medical devices or veterinary biologics

Certification by the Veterinary Administration that the tallow or dicalcium phosphate:

* originates from bovine animals:
o that have been subjected to an ante-mortem and post mortem inspection;
o were not subjected to a stunning process, prior to slaughter, with a device injecting compressed air or gas into the cranial cavity or to a pithing process (laceration, after stunning, of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity);
* has not been prepared using the following SRM or any protein products derived from them:
o the skull including the brain, trigeminal ganglia and eyes, the spinal cord and the vertebral column excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum from all animals aged 30 months or older;
o the small intestine and tonsils from animals of all ages;
o the determination of the age of animals, stunning, dressing and removal, handling and disposition of SRM as inedible material meets the standards prescribed in the Government of Canada’s Meat Hygiene Directive.

6.2.7. For tallow derivatives (other than those made from protein-free tallow as defined in section 3) derived from bovine animals and intended for food, animal food, fertilisers, or as unprocessed material for the preparation of cosmetics, drugs (including pharmaceuticals and natural health products), medical devices or veterinary biologics

Certification by the Veterinary Administration that the tallow derivatives:

* originate from bovine animals:
o that have been subjected to an ante-mortem and post mortem inspection;
o were not subjected to a stunning process, prior to slaughter, with a device injecting compressed air or gas into the cranial cavity or to a pithing process (laceration, after stunning, of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity);
* have not been prepared using the following SRM or any protein products derived from them:
o the skull including the brain, trigeminal ganglia and eyes, the spinal cord and the vertebral column excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum from all animals aged 30 months or older;
o the small intestine and tonsils from animals of all ages;
o the determination of the age of animals, stunning, dressing and removal, handling and disposition of SRM as inedible material meets the standards prescribed in the Government of Canada’s Meat Hygiene Directive;
* have been produced by hydrolysis, saponification or transesterification using high temperature and pressure.

6.2.8. Products derived from bovine animals by subjecting bones to rigorous processes of extraction and purification such as ossein, bone ash, bone charcoal and bone oil and intended for food, animal food, fertilisers, or as unprocessed material for the preparation of cosmetics, drugs (including pharmaceuticals and natural health products), medical devices or veterinary biologics.

Certification by the Veterinary Administration that the products were not derived from:

* skulls and vertebrae (excluding the vertebrae of the tail) from all animals aged 30 months or older;
* have been subjected to a rigorous process of extraction or purification approved by CFIA.

6.2.9. Products and by-products derived from bovine animals that have been subjected to rigorous processes of extraction and purification such as animal glue, oleosterin, triglycerides, glycerol, sorbitan esters and intended for food, animal food, fertilisers, or as unprocessed material for the preparation of cosmetics, drugs (including pharmaceuticals and natural health products), medical devices or veterinary biologics

Certification by the Veterinary Administration that the products and by-products:

* have not been prepared using the following SRM or any protein products derived from them:
o the skull including the brain, trigeminal ganglia and eyes, the spinal cord and the vertebral column excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum from all animals aged 30 months or older;
o the small intestine and tonsils from animals of all ages;
o the determination of the age of animals, stunning, dressing and removal, handling and disposition of SRM as inedible material meets the standards prescribed in the Government of Canada’s Meat Hygiene Directive;
* have been subjected to a rigorous process of extraction or purification approved by CFIA.

6.2.10. Commercially prepared pet food and finished pet chews, such as dried processed ears, pizzles, hooves or tendons

Certification by the Veterinary Administration that the commercially prepared pet food, ingredients for pet food or pet chews:

* do not contain or have not been prepared using the following SRM or any protein products derived from them:
o the skull including the brain, trigeminal ganglia and eyes, the spinal cord and the vertebral column excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum from all animals aged 30 months or older;
o the small intestine and tonsils from animals of all ages;
o the determination of the age of animals meets the standards prescribed in the Government of Canada’s Meat Hygiene Directive.

An exemption from these requirements for commercially prepared pet food and finished pet chews will be considered on a case-by-case basis considering the nature of the product, the source of materials of bovine origin, the manufacturing methods employed, and the intended use.

6.2.11. Cell lines of bovine origin

Certification by the Veterinary Administration that the cell lines were:

* not prepared from bovine animals subjected to a stunning process, prior to slaughter, with a device injecting compressed air or gas into the cranial cavity or to a pithing process (laceration, after stunning, of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity), or;
* not prepared from the following SRM or any protein products derived from them:
o the skull including the brain, trigeminal ganglia and eyes, the spinal cord and the vertebral column excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum from all bovine animals aged 30 months or older;
o the small intestine and tonsils from bovine animals of all ages;
o the determination of the age of animals, stunning, dressing and removal, handling and disposition of SRM as inedible material meets the standards prescribed in the Government of Canada’s Meat Hygiene Directive.

An exemption from this requirement will be considered on a case-by-case basis considering the nature of the cell lines, their intended use and method of disposal.

6.2.12. Veterinary biologics (vaccines, antibody products and diagnostic kits) containing material of bovine origin intended for use in animals

Certification by the Veterinary Administration that the veterinary biologics were:

* not prepared from bovine animals subjected to a stunning process, prior to slaughter, with a device injecting compressed air or gas into the cranial cavity or to a pithing process (laceration, after stunning, of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity), or;
* not prepared from the following SRM or any protein products derived from them:
o the skull including the brain, trigeminal ganglia and eyes, the spinal cord and the vertebral column excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum from all bovine animals aged 30 months or older;
o the small intestine and tonsils from bovine animals of all ages;
o the determination of the age of animals, stunning, dressing and removal, handling and disposition of SRM as inedible material meets the standards prescribed in the Government of Canada’s Meat Hygiene Directive.

An exemption from this requirement for veterinary biologics will be considered on a case-by-case basis considering the nature of the product, the source of materials of bovine origin, the manufacturing methods employed, and the intended use.
6.3. Category 3 Countries (undetermined BSE-risk)

6.3.1. Definition

Category 3 countries are those countries where

either:

* a risk assessment has not been undertaken, completed4 or subjected to a regular review,

or where:

* it is likely that imported commodities were contaminated or infected with a TSE-agent, and/or;
* it is likely that a TSE exists in the country’s domestic or wild ruminant population, and;
* either indigenous BSE-cases have been reported or it is likely that indigenous bovine animals have been exposed to a TSE-agent, and;
* the measures in place are unlikely to effectively control or eradicate BSE.

6.3.2. Live bovine animals

This commodity is prohibited from Category 3 countries (undetermined BSE-risk).

An exemption from this prohibition for live bovine animals will be considered on a case-by-case basis considering the intended use of the animals, for example, animals imported for a temporary stay; animals for immediate slaughter; animals imported for medical use, scientific research or zoological collections; bulls destined for semen production centers.

6.3.3. Meat and meat products from bovine animals other than deboned skeletal muscle meat as defined in section 3 (g)

The conditions set down for this commodity are the same as those specified for a Category 2 country (controlled BSE-risk) in section 6.2.4.

6.3.4. Gelatin and collagen prepared from the bones of bovine animals

The conditions set down for this commodity are the same as those specified for a Category 2 country (controlled BSE-risk) in section 6.2.5.

6.3.5. Tallow (other than protein-free tallow as defined in section 3) and dicalcium phosphate (other than protein or fat free dicalcium phosphate as defined in section 3) derived from bovine animals

This commodity is prohibited from Category 3 countries (undetermined BSE-risk).

6.3.6. For tallow derivatives (other than those made from protein-free tallow as defined in section 3) derived from bovine animals and intended for food, animal food, fertilisers, or as unprocessed material for the preparation of cosmetics, drugs (including pharmaceuticals and natural health products), medical devices or veterinary biologics

The conditions set down for this commodity are the same as those specified for a Category 2 country (controlled BSE-risk) in section 6.2.7.

6.3.7. Products derived from bovine animals by subjecting bones to rigorous processes of extraction and purification such as ossein, bone ash, bone charcoal and bone oil and intended for food, animal food, fertilisers, or as unprocessed material for the preparation of cosmetics, drugs (including pharmaceuticals and natural health products), medical devices or veterinary biologics

The conditions set down for this commodity are the same as those specified for a Category 2 country (controlled BSE-risk) in section 6.2.8.

6.3.8. Products and by-products derived from bovine animals that have been subjected to rigorous processes of extraction and purification such as animal glue, oleosterin, triglycerides, glycerol, sorbitan esters and intended for food, animal food, fertilisers, or as unprocessed material for the preparation of cosmetics, drugs (including pharmaceuticals and natural health products), medical devices or veterinary biologics

The conditions set down for this commodity are the same as those specified for a Category 2 country (controlled BSE-risk) in section 6.2.9.

6.3.9. Commercially prepared pet food and finished pet chews, such as dried processed ears, pizzles, hooves or tendons

The conditions set down for this commodity are the same as those specified for a Category 2 country (controlled BSE-risk) in section 6.2.10.

6.3.10. Cell lines of bovine origin

The conditions set down for this commodity are the same as those specified for a Category 2 country (controlled BSE-risk) in section 6.2.11.

6.3.11. Veterinary biologics (vaccines, antibody products and diagnostic kits) containing material of bovine origin intended for use in animals

The conditions set down for this commodity are the same as those specified for a Category 2 country (controlled BSE-risk) in section 6.2.12.
Appendix 1
A. Determining the BSE-risk category of a country:

A risk assessment, to determine the BSE-risk status of the bovine animal population and allocate an exporting country to a particular BSE-risk category consists of four parts:

* Release assessment
* Exposure assessment
* Consequence assessment
* Risk estimation

A complete risk assessment should be undertaken for those countries that have either not reported BSE-cases or have only reported BSE-cases in imported animals. For countries that have reported BSE cases in indigenous animals it may not be necessary to undertake a detailed release and exposure assessment. Rather, a consequence assessment may be all that is required to determine if BSE is being effectively controlled.

The risk assessment must be reviewed regularly to ensure that adequate account is taken of changes in risk factors that could affect the BSE-risk status of a country, including:

* the detection of BSE in a previously unaffected country that may have exported commodities of concern to the country being evaluated;
* changes in the country’s import policies and/or practices;
* data and/or information that was previously unavailable is provided;
* changes to the OIE Code;
* new scientific findings such as the confirmation of natural cases of BSE in sheep;
* new diagnostic techniques, for example a live animal test;
* changes in assumptions;
* changes in the human epidemiology of BSE.

A.1. Release assessment

The release assessment determines the likelihood that a transmissible spongiform encephalopathy (TSE) agent has been introduced into the exporting country via importation of the following commodities potentially contaminated with a TSE agent:

* meat-and-bone meal or greaves;
* live animals;
* animal feed and feed ingredients;
* products of animal origin for human consumption (with the exception of those commodities that can be imported into or transit Canada without BSE-related restrictions as listed in section 3);
* products of animal origin for in vivo use in bovine animals.

The range of commodities included here is based on a consideration that all the evidence to date indicates that the vast majority of BSE cases have arisen through the ingestion of animal food contaminated with the BSE-agent, with vertical transmission from dam to offspring potentially accounting for only a very small number of cases. Although there have been no reports of BSE cases having arisen through the use of in vivo products contaminated with a TSE-agent, considering the potential for widespread exposure, such products also need to be taken into account.

Naturally occurring TSEs have been reported in several species from which these commodities are derived. They are all members of the Order Artiodactyla (even toed ungulates)5 and belong to the suborder Ruminantia (the ruminants). The species involved are domestic cattle from the subfamily Bovinae, which are affected by bovine spongiform encephalopathy (BSE); domestic sheep and goats from the subfamily Caprinae, which are affected by scrapie; and both wild and farmed deer and elk from the family Cervidae, which are affected by chronic wasting disease (CWD). It is worth noting that a naturally occurring TSE has not been reported in Camelids (llamas, alpacas, vicunas and camels). While they are not classified as ruminants per se they are closely related, belonging to the suborder Tylopda.

Apart from BSE none of these TSEs have been reported to affect species other than their natural hosts under field conditions. BSE has been reported in both domestic cats and a number of other species from the family Felidae held in zoological gardens in the United Kingdom (UK). In addition BSE was found in several ruminant species, also in zoological gardens in the UK. These animals all belong to the family Bovidae6, the same family in which cattle, sheep and goats are found. Recently, BSE was confirmed in a dairy goat in France7. This was the first recorded naturally occurring case of BSE affecting a commercially reared ruminant animal other than cattle.

Cross species transmission studies have demonstrated all of these TSEs are capable of infecting species other than their natural host. For instance, cattle are susceptible to experimental challenge with scrapie and CWD. Similarly sheep and goats are susceptible to BSE8, 9 and recently BSE has been confirmed in non-human primates (macaque monkeys) following oral challenge10. However, significant uncertainty remains regarding the likelihood of natural challenge and infection with these TSEs in non-host species. Experimental challenge studies involving deer, elk and camelids have not been reported in the literature to date. Although cattle have been successfully challenged with CWD intracerebrally there appears to be a significant species barrier. These findings are supported by field observations over a number of years where cattle, which were co-pastured with CWD-affected deer, did not develop the disease11. Whether or not this is indicative of a species barrier in deer or elk for BSE is uncertain.

While the ultimate origin of BSE remains elusive there has been considerable speculation concerning the role of a TSE agent from another mammalian species such as scrapie in sheep12. In addition, readily commercially diagnostic techniques that could easily discriminate between a TSE-agent such as scrapie and BSE have not been validated until recently (2005) 13, 14.

Considering that:

* the origin of BSE remains uncertain;
* naturally occurring TSEs have been reported in a number of closely related ruminant species;
* cross-species transmission studies have confirmed that at least several of these species are susceptible to a TSE from another host species;
* significant uncertainty remains regarding the likelihood of natural challenge and infection with any of these TSEs;
* tests that could discriminate readily between the various TSE agents have not been commercially available until recently (2005).

the range of species to consider in the release assessment from which the commodities listed at the beginning of this section are likely to be derived, consist of the following animals, hereafter collectively referred to as ruminants:

* bovine animals15
* sheep and goats
* deer and elk

Since BSE has a prolonged incubation period and by the time it is detected in the bovine animal population it is likely to have been present for the equivalent of two to three incubation periods16 or more, the release assessment should extend back over at least the last 15 years and preferably since the early 1980s.

Factors to consider in the release assessment include:

* the nature, extent and duration of past and current import legislation and policies relative to the TSEs;
* whether any or all of the commodities being considered have been imported from countries that have either reported a TSE in imported or indigenous animals or from countries with an undetermined BSE-risk, and if so:
o the period during which these commodities were imported and their respective quantities.

A.2. Exposure assessment

For the purposes of determining the BSE status of the bovine animal population of an exporting country an exposure assessment:

* identifies and describes the biological pathways necessary for the exposure of bovine animals to a TSE-agent through imported commodities and/or from a TSE that already exists in the country’s domestic or wild ruminant population;
* determines the likelihood that bovine animals have been exposed to a TSE-agent via these pathways;
* estimates the likely extent, timing and duration of exposure to a TSE-agent in the bovine animal population.

The rationale for including all TSEs in the exposure assessment is based on a consideration that significant uncertainties remain concerning:

* the origin of BSE;
* the potential for the BSE-agent to naturally infect species other than bovine animals such as sheep and goats, which may then be indistinguishable from scrapie;
* the potential for other TSEs, such as scrapie and chronic wasting disease, to infect bovine animals naturally and be indistinguishable from BSE.

Factors to consider that would lead to the exposure of bovine animals in the exporting country to a TSE-agent include:

* the intended use of imported ruminants or products derived from such animals;
* the identification and tracking of imported ruminants including their ultimate fate, whether they were tested for a TSE and if their carcass or parts of their carcass potentially entered the animal feed chain;
* animal demographics which describes the extent of knowledge of the population structure of ruminant animals including culling and slaughter practices and disposal of dead or condemned animals;
* the epidemiological situation concerning all TSE-agents in the animal population of the country;
* the nature, scope, duration and evidence of enforcement and/or compliance with any legislation relative to TSEs including:
o control and/or eradication programs;
o controls over material potentially containing a TSE-agent such as a specified risk materials (SRM) ban;
o controls over rendering methods and parameters;
o controls on the production, distribution and consumption of animal feed.
* the nature, extent and compliance with any bans, whether voluntary or compulsory, on the feeding of material potentially containing a TSE-agent, including meat-and-bone meal or greaves, to ruminant animals;
* measures to prevent cross-contamination of animal feed with material potentially containing a TSE-agent , whether voluntary or compulsory and evidence of enforcement and/or compliance;
* disposal practices:
o waste generated in slaughterhouses, meat processing facilities, domestic households, restaurants or any other facility involved in the processing and preparation of fresh meat and meat products that potentially contain a TSE-agent;
o ruminant animals that die on farm, are dead on arrival in a slaughterhouses and that are condemned at ante or post-mortem inspection.
* rendering practices including dedication of lines, facilities and the parameters of the rendering process;
* methods of animal feed manufacture including ingredients and dedication of lines or facilities;
* farming and husbandry practices that could lead to bovine animals consuming feed potentially contaminated with a TSE-agent;
* measures to prevent the contamination of domestically manufactured products destined for in vivo use with material potentially containing a TSE-agent.

The risk assessment may be concluded at this point if the likelihoods of both the release and exposure assessments are considered to be negligible.

A.3. Consequence assessment

A.3.1. For countries that have either not reported BSE-cases or have only reported BSE-cases in imported animals

In this situation it is assumed that, if the outcome from the exposure assessment is that the likelihood of bovine animals having been exposed to a TSE-agent cannot be considered to be negligible, BSE infected animals are likely to exist in the population.

A consequence assessment determines:

* the likelihood that BSE-cases would be detected if present in the bovine animal population;
* the likelihood that any measures introduced for BSE, whether pre-emptive or in response to the detection of BSE-cases in imported animals, would effectively control BSE or lead to its eradication.

A.3.2. For countries that have reported BSE-cases in indigenous animals

A consequence assessment determines:

* the likelihood that current and past measures are either effectively controlling BSE or will lead to its eventual eradication.

Factors to consider in addition to those listed under the exposure assessment include:

* an evaluation of the capacity of a country’s Veterinary Service and legislative support for BSE surveillance, eradication and control;
* details and results of BSE control and/or eradication programs including the measures taken in response to the detection of a BSE case ;
* opportunities for recycling and amplification of the BSE-agent through the consumption by bovine animals of meat-and-bone meal or greaves, or other feed or feed ingredients potentially contaminated with ruminant derived meat-and-bone meal or greaves;
* the existence, duration and extent of on-going awareness program for veterinarians, farmers, and workers involved in transportation, marketing and slaughter of bovine animals to encourage reporting of all cases of neurological disease in adult bovine animals and fallen stock;
* the existence and implementation date of compulsory notification and investigation of all bovine animals showing clinical signs consistent with BSE;
* the existence, duration and extent of BSE surveillance and monitoring systems taking into account the guidelines in Appendix 3.8.4 of the Code;
* details of the diagnostic procedures for BSE, including:
o case definitions for BSE-suspects and surveillance candidates including their age;
o whether an examination in an approved laboratory of brain or other tissues is undertaken;
o the laboratory procedures for screening and confirmation of BSE.

A.4. Risk estimation

The criteria for determining the BSE-risk category of a country, based on the outcomes from the release, exposure and consequence assessments are outlined in the following sections:

A.4.1. Category 1. Negligible BSE-risk

*

a) For countries that have never reported a BSE-case
Either:
o If the conclusions of both the release and exposure assessment are negligible the overall risk is estimated to be negligible and the country is classified as negligible BSE-risk (Category 1).

Or:
*
o If the overall conclusion of the release and exposure assessment is greater than negligible, but the likelihood of exposure during at least the last 7 years is negligible, and the level of surveillance maintained during throughout this period should have detected BSE cases if they were present, the country is classified as negligible BSE-risk (Category 1).
*

b) For countries that have reported BSE-cases in imported and/or indigenous animals

Before the country can be considered as presenting a negligible BSE-risk it should satisfy each of the following conditions for a period of at least seven years:

* the likelihood of imported commodities referred to in section A.1 being contaminated or infected with a TSE-agent must remain negligible;
* the likelihood of bovine animals having been exposed to a TSE that exists in the country’s domestic or wild ruminant population must remain negligible;
* the measures to eradicate BSE must be maintained to ensure that the likelihood of bovine animals being exposed to a TSE-agent remains negligible;
* a level of surveillance capable of demonstrating the effectiveness of eradication measures has been maintained without the detection of any BSE-cases.

A.4.2. Category 2. controlled BSE-risk:

If the conclusion of the risk assessment is that:

* it is likely that those commodities referred to in section A.1 were contaminated or infected with a TSE-agent when imported, and/or;
* it is likely that a TSE exists in the country’s domestic or wild ruminant population, and;
* either indigenous BSE-cases have been reported, or it is likely that indigenous bovine animals are likely to have been exposed to a TSE-agent, and;
* the measures in place are effectively controlling BSE and are likely to lead to its eradication;
* a level of surveillance capable of demonstrating the effectiveness of the measures to control BSE has been maintained.

the country is classified as controlled BSE-risk (Category 2).

A.4.3. Category 3. Undetermined BSE-risk

If either:

* a risk assessment for a particular country has not been undertaken, completed17 or subjected to a regular review

Or:

* the conclusion of the risk assessment is that:
o it is likely that those commodities referred to in section A.1 were contaminated or infected with a TSE-agent when imported, and/or;
o it is likely that a TSE exists in the country’s domestic or wild ruminant population, and;
o either indigenous BSE-cases have been reported or it is likely that indigenous bovine animals have been exposed to a TSE-agent, and;
o the measures in place are unlikely to effectively control or eradicate BSE.

the country is classified as undetermined BSE-risk.

In those situations in which a risk assessment is no longer up to date, provided that the assessment is reviewed with a favourable outcome, the country may revert to its former status. For a country previously classified as undetermined BSE-risk, provided that the measures are modified to ensure that they would effectively control or eradicate BSE, the country could be considered as presenting a controlled BSE-risk.

Original signed by
Dr. Jim Clark
A/Director
Animal Health and Production Division
Appendix 2
Glossary of legal definitions

Animal

* Health of Animals Act - includes an embryo and a fertilized egg or ovum.

Animal food

* Health of Animals Act - any thing that is capable of being a nutriment for animals and includes any of the constituent elements of an animal ration
* Health of Animal Regulations - food containing an animal product or animal by-product for chickens, turkeys, ducks, geese, ratites, game birds, ruminants, swine or horses but does not include such things as fish meal or vitamin or mineral supplements which do not contain animal products or by-products.

Animal by-product

* Health of Animals Act - includes blood or any of its components, bones, bristles, feathers, flesh, hair, hides, hoofs, horns, offal, skins and wool, and any thing containing any of those things;
* Health of Animals Regulations - means an animal by-product that originated from a bird or from any mammal except a member of the orders Rodentia, Cetacea, Pinnipedia and Sirenia.

Animal product

* Health of Animals Act - includes cream, eggs, milk, non-fertilized ova and semen;
* Health of Animals Regulations - means an animal product that originated from a bird or from any mammal except a member of the orders Rodentia, Cetacea, Pinnipedia and Sirenia.

Animal pathogen

* Health of Animals Regulations - includes any animal pathogen derived through biotechnology.

Bovine

* Health of Animals Regulations - means cattle or bison domestically raised or kept, but for the purposes of the import reference document does not include a bison that has ever been in contact with or part of a wild herd.

Cosmetic

* Food and Drug Act - includes any substance or mixture of substances manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes.

Drug

* Food and Drug Act - includes any substance or mixture of substances manufactured, sold or represented for use in (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals, (b) restoring, correcting or modifying organic functions in human beings or animals, or (c) disinfection in premises in which food is manufactured, prepared or kept.

Device

* Food and Drug Act - means any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals, (b) restoring, correcting or modifying a body function or the body structure of human beings or animals, (c) the diagnosis of pregnancy in human beings or animals, or (d) the care of human beings or animals during pregnancy and at and after birth of the offspring, including care of the offspring, and includes a contraceptive device but does not include a drug.

Food

* Food and Drug Act - includes any article manufactured, sold or represented for use as food or drink for human beings, chewing gum, and any ingredient that may be mixed with food for any purpose whatever.

Germplasm

* Health of Animals Regulations - means semen, male or female germ cells or genetic material taken from a male or female germ cell for the purpose of producing a zygote and includes embryos but does not include a hatching egg.

Meat

* Meat Inspection Regulations - means the edible part of a carcass that is the muscle associated with the skeleton, tongue, diaphragm, heart, gizzard or mammalian oesophagus, with or without accompanying and overlying fat, together with those parts of the bones, skin, sinews, nerves, blood vessels and other tissues that normally accompany the muscle and are not ordinarily removed in dressing a carcass, but does not include the muscle associated with the lips, snout, scalp or ears, mechanically separated meat or meat to which an ingredient other than meat has been added.

Meat product

* Meat Inspection Act - means (a) a carcass, (b) the blood of an animal or a product or by-product of a carcass, or (c) a product containing anything described in (b);
* Meat Inspection Regulations - means edible blood, an edible organ or edible tissue that was derived from the carcass of a food animal, but does not include meat or mechanically separated meat.

Ruminant

* Health of Animals Regulations - means an animal of the suborder Ruminatiae and includes an animal of the family Camelidae.

Specified risk material

* Food and Drug Regulations and Health of Animals Regulations - means (a) the skull, brain, trigeminal ganglia, eyes, tonsils, spinal cord and dorsal root ganglia of cattle aged 30 months or older; and (b) the distal ileum of cattle of all ages.
o Through the application of the Meat Hygiene Directive (2003-18 of July 24, 2003), issued under the Meat Inspection Regulations, the tissues that are to be removed to ensure that SRM are excluded consist of:
+ the skull including the brain, trigeminal ganglia and eyes, the tonsils, the spinal cord and the vertebral column excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum from all cattle 18 aged 30 months or older;
+ the small intestine from cattle of all ages.
o For the purpose of this BSE import policy this same list of tissues, not only from cattle but also from bison, is defined as SRM, that is:
+ the skull including the brain, trigeminal ganglia and eyes, the tonsils, the spinal cord and the vertebral column excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum from all bovine animals aged 30 months or older;
+ the small intestine from bovine animals of all ages.

Veterinary biologic

* Health of Animals Act means (a) a helminth, protozoa or micro-organism, (b) a substance or mixture of substances derived from animals, helminths, protozoa or micro-organisms, or (c) a substance of synthetic origin that is manufactured, sold or represented for use in restoring, correcting or modifying organic functions in animals or for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or the symptoms thereof, in animals;
* Health of Animal Regulations - includes any veterinary biologic derived through biotechnology.

1 Integrated Taxonomic Information System. http://www.itis.usda.gov/servlet/SingleRpt/SingleRpt

2 Products intended for human consumption from a Category 2 country (controlled BSE-risk) or a Category 3 country (undetermined BSE-risk) must not be prepared from material containing SRM or be derived from bovine animals subjected to a stunning process, prior to slaughter, with a device injecting compressed air or gas into the cranial cavity or to a pithing process.

3 Details of the process deemed to be equivalent and supporting data and references should be provided to CFIA for approval prior to the importation of this commodity.

4 In some situations it may not be possible to complete the risk assessment as a result of insufficient and or poor quality data.

5 The Ultimate Ungulate Page. http://www.ultimateungulate.com/index.html

6 OIE, Technical Disease Cards, BSE, 2004. http://www.oie.int/eng/maladies/fiches/a_B115.htm Bovidae (domestic cattle, nyala [Tragelaphus angasi], greater kudu [Tragelaphus strepsiceros] and presumed similar origin for cases in gemsbok [Oryx gazella], Arabian oryx [Oryx leucoryx], eland [Taurotragus oryx], scimitar-horned oryx [Oryx dammah] and bison [Bison bison]). Felidae (domestic cat and presumed bovine origin in cheetah [Acinonyx jubatus], puma [Felis concolor], ocelot [Felis pardalis] and tiger [Panthera tigris]). Experimentally transmissible to cattle, pigs, sheep, goats, mice, mink, marmosets and macaque monkeys.

7 EUROPA - Food and Feed Safety. BSE/Scrapie - TSE in goats. February 2005. http://www.europa.eu.int/comm/food/food/biosafety/bse/goats_index_en.htm

8 Lasmezas CI. The transmissible spongiform encephalophathies. Rev. sci. tech. Off. Int. Epiz., 2003, 22 (1), 23-36

9 Schreuder BEC, Somerville RA. Bovine spongiform encephalopathy in sheep? Rev. sci. tech. Off. Int. Epiz., 2003, 22 (1), 103-120

10 Lasmézas CI, Comoy E, Hawkins S, Herzog C, Mouthon F, Konold T, Auvré F, Correia E, Lescoutra-Etchegaray N, Salès N, Wells G, Brown P, Deslys J-P. Risk of oral infection with bovine spongiform encephalopathy agent in primates. The Lancet, Volume 365, Issue 9461, 26 February 2005-4 March 2005, Pages 781-783

11 Salman MD. Chronic Wasting Disease in Deer and Elk: Scientific Facts and Findings. J. Vet. Med. Sci. 65 (7): 761-768, 2003

12 Prince MJ, Bailey JA, Barrowman PR, Bishop KJ, Campbell GR, Wood JM. Bovine Spongiform Encephalopathy. Rev. sci. tech. Off. Int. Epiz, 2003, 22 (1) 37-60

13 Heim D. Kihm U. Risk management of transmissible spongiform encephalopathies in Europe. Rev. sci. tech. Off. Int. Epiz, 2003, 22 (1), 179-199

14 VLA lunches new discriminatort diagnostic test. April, 2005. http://www.defra.gov.uk/news/2005/050404h.htm

15 In this policy the term bovine refers to animals belonging to the Genus Bos, which includes cattle (Bos taurus and Bos indicus) and bison (Bos bison).

16 The average incubation period is approximately 5 - 6 years.

17 In some situations it may not be possible to complete the risk assessment as a result of insufficient and or poor quality data.

18 The Meat Hygiene Directive defines cattle as animals of the species Bos taurus or Bos indicus; but not including other ruminants such as bison, muskox, yak or water buffalo.

http://www.inspection.gc.ca/english/anima/heasan/policy/ie-2005-9e.shtml


http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB/.cmd/ad/.ar/sa.retrievecontent/.c/6_2_1UH/.ce/7_2_5JM/.p/5_2_4TQ/.d/3/_th/J_2_9D/_s.7_0_A/7_0_1OB?PC_7_2_5JM_contentid=2005%2F12%2F0543.xml&PC_7_2_5JM_navtype=RT&PC_7_2_5JM_parentnav=TRANSCRIPTS_SPEECHES&PC_7_2_5JM_navid=TRANSCRIPT#7_2_5JM

>>>The other thing I would tell you about Japan, and this is really unique to Japan -- as you know we've agreed in this first phase with Japan to start at meat from animals 20 months and under. And you're just not going to find BSE there. It's just not there. So from a number of standpoints, I can safely assure the Japanese consumer that beef is safe. <<<


r i g h t! kinda like the WMD issue and gitmo, no lies here either.


the myth that cattle under 30 months of age are free from BSE/TSE is just that, a myth, and it's a false myth !


the youngest age of BSE case to date is 20 months old; As at: 31 May
2003 Year of onset Age youngest case (mnths) Age 2nd youngest case
(mnths) Age 2nd oldest case (yrs.mnths) Age oldest case (yrs.mnths) 1986
30 33 5.03 5.07 1987 30 31 9.09 10.00 1988 24 27 10.02 11.01(2) 1989 21
24(4) 12.00(2) 15.04 1990 24(2) 26 13.03 14.00 1991 24 26(3) 14.02 17.05
1992 20 26 15.02 16.02 1993 29 30(3) 14.10 18.10 1994 30(2) 31(2) 14.05
16.07 1995 24 32 14.09 15.05 1996 29 30 15.07 17.02 1997 37(7) 38(3)
14.09 15.01 1998 34 36 14.07 15.05 1999 39(2) 41 13.07 13.10 2000 40 42
17.08 19.09 2001 48(2) 56 14.10 14.11 2002 51 52 15.08 15.09(2) 2003 50
62 11.11 14.11

http://www.defra.gov.uk/animalh/bse/bse-statistics/bse/yng-old.html

http://www.defra.gov.uk/animalh/bse/index.html

The implications of the Swiss result for Britain, which has had the most
BSE, are complex. Only cattle aged 30 months or younger are eaten in
Britain, on the assumption, based on feeding trials, that cattle of that
age, even if they were infected as calves, have not yet accumulated
enough prions to be infectious. But the youngest cow to develop BSE on
record in Britain was 20 months old, showing some are fast incubators.
Models predict that 200-300 cattle under 30 months per year are infected
with BSE and enter the food chain currently in Britain. Of these 3-5
could be fast incubators and carrying detectable quantities of prion.

http://www.sare.org/htdocs/hypermail/html-home/28-html/0359.html

https://web01.aphis.usda.gov/BSEcom.nsf/0/b78ba677e2b0c12185256dd300649f9d?OpenDocument&AutoFramed


SO, with GWs BSE MRR policy, like i said, it is nothing more than a legal tool to trade ALL STRAINS of this mad cow agent around the globe. WE know of atypical TSE in USA via Marsh et al, and we know when USA scrapie is transmitted to USA cow, it does not look like UK BSE. BUT what about Japans beef brought into USA? seems they have atypical TSE in Japan cattle that is in very young cattle and evidently, there TSE agent has even been detected in the peripheral nerves (sciatic nerve, tibial nerve, vagus nerve), so why would USA want to import that into USA$ With our much superior BSE/TSE surveillance system in USA cattle and the fact we have had this fabulous ruminant to ruminant mad cow feed ban in effect since 8/4/97, where no cattle have been fed ruminant protein since then;-), why should we risk this new phenotype of TSE to the USA, since we have all the other TSEs here in the USA under control:-(not)$


Muscle tissue has recently been detected with PrPSc
in the peripheral nerves (sciatic nerve, tibial nerve, vagus nerve) of the 11th BSE
cow in Japan (Yoshifumi Iwamaru et al). also recently, Aguzzi et al Letter to the Editor
Vet Pathol 42:107-108 (2005), Prusiner et al CDI test is another example of detection
of the TSE agent in muscle in sCJD, Herbert Budka et al CJD and inclusion body myositis:
Abundant Disease-Associated Prion Protein in Muscle, and older studies from Watson
Meldrum et al Scrapie agent in muscle - Pattison I A (1990), references as follow ;


PrPSc distribution of a natural case of bovine
spongiform encephalopathy

Yoshifumi Iwamaru, Yuka Okubo, Tamako Ikeda, Hiroko Hayashi, Mori-
kazu Imamura, Takashi Yokoyama and Morikazu Shinagawa

Priori Disease Research Center, National Institute of Animal Health, 3-1-5
Kannondai, Tsukuba 305-0856 Japan gan@affrc.go.jp

Abstract

Bovine spongiform encephalopathy (BSE) is a disease of cattle that causes
progressive neurodegeneration of the central nervous system. Infectivity
of BSE agent is accompanied with an abnormal isoform of prion protein
(PrPSc).

The specified risk materials (SRM) are tissues potentially carrying BSE
infectivity. The following tissues are designated as SRM in Japan: the
skull including the brain and eyes but excluding the glossa and the masse-
ter muscle, the vertebral column excluding the vertebrae of the tail, spinal
cord, distal illeum. For a risk management step, the use of SRM in both
animal feed or human food has been prohibited. However, detailed
PrPSc distribution remains obscure in BSE cattle and it has caused con-
troversies about definitions of SRM. Therefore we have examined PrPSc
distribution in a BSE cattle by Western blotting to reassess definitions of
SRM.

The 11th BSE case in Japan was detected in fallen stock surveillance.
The carcass was stocked in the refrigerator. For the detection of PrPSc,
200 mg of tissue samples were homogenized. Following collagenase
treatment, samples were digested with proteinase K. After digestion,
PrPSc was precipitated by sodium phosphotungstate (PTA). The pellets
were subjected to Western blotting using the standard procedure.
Anti-prion protein monoclonal antibody (mAb) T2 conjugated horseradish
peroxidase was used for the detection of PrPSc.

PrPSc was detected in brain, spinal cord, dorsal root ganglia, trigeminal
ganglia, sublingual ganglion, retina. In addition, PrPSc was also detected
in the peripheral nerves (sciatic nerve, tibial nerve, vagus nerve).

Our results suggest that the currently accepted definitions of SRM in
BSE cattle may need to be reexamined. ...

179

T. Kitamoto (Ed.)
PRIONS
Food and Drug Safety
================


ALSO from the International Symposium of Prion Diseases held in Sendai, October 31, to
November 2, 2004;


Bovine spongiform encephalopathy (BSE) in Japan


snip...


"Furthermore, current studies into transmission of cases of BSE that are
atypical or that develop in young cattle are expected to amplify the BSE
prion"


NO. Date conf. Farm Birth place and Date Age at diagnosis


8. 2003.10.6. Fukushima Tochigi 2001.10.13. 23


9. 2003.11.4. Hiroshima Hyogo 2002.1.13. 21


Test results


# 8b, 9c cows Elisa Positive, WB Positive, IHC negative, histopathology
negative


b = atypical BSE case


c = case of BSE in a young animal


b,c, No PrPSc on IHC, and no spongiform change on histology


International Symposium of Prion Diseases held in Sendai, October 31, to
November 2, 2004.

The hardback book title is 'PRIONS' Food and Drug Safety
T. Kitamoto (Ed.)


Tetsuyuki Kitamoto
Professor and Chairman
Department of Prion Research
Tohoku University School of Medicine
2-1 SeiryoAoba-ku, Sendai 980-8575, JAPAN
TEL +81-22-717-8147 FAX +81-22-717-8148
e-mail; kitamoto@mail.tains.tohoku.ac.jp
Symposium Secretariat
Kyomi Sasaki
TEL +81-22-717-8233 FAX +81-22-717-7656
e-mail: kvomi-sasaki@mail.tains.tohoku.ac.ip


snip...end


THIS brings up about another 9,200 points of concern. IF you look above at these two atypical TSE cows from Japan, (of which we could very well export more just like it), please notice the testing protocol;


>>># 8b, 9c cows Elisa Positive, WB Positive, IHC negative, histopathology
negative <<<


9,200 points of mad cow concern is the fact the USDA et al DID NOT use rapid TSE test OR WB test to test for BSE/TSE on 9,200 cattle, they used the least likely to find the agent only, the IHC, of which, DID NOT show up on two of those very young atypical positive Japanese cows, PLUS, like the one TEXAS cow they did finally confirm after 7+ months of trying to cover up. besides this, we have some 500,000 bse/tse test, the infamous June 2004 enhanced BSE/TSE surveillance (cover-up) program, where here the testing protocol was terribly flawwed on all these cows, where only IHC and rapid testing was used, no WB. Dr. Detwiler warned of this problem way back;


USDA 2003

We have to be careful that we don't get so set in the way we do things that
we
forget to look for different emerging variations of disease. We've gotten
away from collecting the whole brain in our systems. We're using the brain
stem and we're looking in only one area. In Norway, they were doing a
project and looking at cases of Scrapie, and they found this where they did
not find lesions or PRP in the area of the obex. They found it in the
cerebellum and the cerebrum. It's a good lesson for us. Ames had to go
back and change the procedure for looking at Scrapie samples. In the USDA,
we had routinely looked at all the sections of the brain, and then we got
away from it. They've recently gone back.
Dr. Keller: Tissues are routinely tested, based on which tissue provides an
'official' test result as recognized by APHIS
.

Dr. Detwiler: That's on the slaughter. But on the clinical cases, aren't
they still asking for the brain? But even on the slaughter, they're looking
only at the brainstem. We may be missing certain things if we confine
ourselves to one area.


snip.............


Dr. Detwiler: It seems a good idea, but I'm not aware of it.
Another important thing to get across to the public is that the negatives
do not guarantee absence of infectivity. The animal could be early in the
disease and the incubation period. Even sample collection is so important.
If you're not collecting the right area of the brain in sheep, or if
collecting lymphoreticular tissue, and you don't get a good biopsy, you
could miss the area with the PRP in it and come up with a negative test.
There's a new, unusual form of Scrapie that's been detected in Norway. We
have to be careful that we don't get so set in the way we do things that we
forget to look for different emerging variations of disease. We've gotten
away from collecting the whole brain in our systems. We're using the brain
stem and we're looking in only one area. In Norway, they were doing a
project and looking at cases of Scrapie, and they found this where they did
not find lesions or PRP in the area of the obex. They found it in the
cerebellum and the cerebrum. It's a good lesson for us. Ames had to go
back and change the procedure for looking at Scrapie samples. In the USDA,
we had routinely looked at all the sections of the brain, and then we got
away from it. They've recently gone back.

Dr. Keller: Tissues are routinely tested, based on which tissue provides an
'official' test result as recognized by APHIS
.

Dr. Detwiler: That's on the slaughter. But on the clinical cases, aren't
they still asking for the brain? But even on the slaughter, they're looking
only at the brainstem. We may be missing certain things if we confine
ourselves to one area.


snip...


FULL TEXT;


Completely Edited Version
PRION ROUNDTABLE


Accomplished this day, Wednesday, December 11, 2003, Denver, Colorado


National Veterinary Services Laboratory (NVSL) Immunohistochemistry (IHC) Testing Summary

The BSE enhanced surveillance program involves the use of a rapid screening test, followed by confirmatory testing for any samples that come back "inconclusive." The weekly summary below captures all rapid tests conducted as part of the enhanced surveillance effort. It should be noted that since the enhanced surveillance program began, USDA has also conducted approximately 9,200 routine IHC tests on samples that did not first undergo rapid testing. This was done to ensure that samples inappropriate for the rapid screen test were still tested, and also to monitor and improve upon IHC testing protocols. Of those 9,200 routine tests, one test returned a non-definitive result on July 27, 2005. That sample underwent additional testing at NVSL, as well as at the Veterinary Laboratories Agency in Weybridge, England, and results were negative. ...


http://www.aphis.usda.gov/lpa/issues/bse_testing/test_results.html


APHIS et al forgets to add here that on that one additional non-definitive test of July 27, 2005, here again they could not use WB due to samples being preserved. Here in 2005 we have still not gotten the proper BSE/TSE testing protocol done correctly, after being told that we did since 1997.


hey, but its not about 'sound science' or 'human health'. GWs enhanced SRM program was nothing more than commodities and futures in action;


Our analysis suggests that if all slaughter animals are tested, but

there is no increase in access to either the Japanese or

South Korean markets, the result would be a net loss of

$17.50 (the estimated cost of testing) per head. Alternatively,

if full access to the Japanese and South Korean

markets is regained without implementing a broad

based BSE testing program, the potential revenue gain

ranges from about $45 to $66 per head (Figure 1).


http://www.oznet.ksu.edu/library/agec2/MF2679.pdf


GW seems to get his cake and eat it too $

nothing like 'sound science' in this administration, to hell with human health.


>>>Then you do a comparison of the countries. We have a herd size of about 90 million. We process about 30 million animals a year, thereabouts, probably a little bit more than that. We've been able to identify since the enhanced surveillance started one case that was actually so difficult to find we had to test and test and test to find it even. <<<


IN TEXAS we feed our cattle 5.5 grams of potentially BSE/TSE tainted protein, and that's o.k. per the FDA;


FOR IMMEDIATE RELEASE
P01-05
January 30, 2001
Print Media: 301-827-6242
Consumer Inquiries: 888-INFO-FDA


--------------------------------------------------------------------------------

Note: On Dec. 23, 2003, the U.S. Department of Agriculture reported that a cow in Washington state had tested positive for bovine spongiform encephalopathy (BSE, or mad cow disease). As a result, information on this Web page stating that no BSE cases had been found in the United States is now incorrect. However, because other information on this page continues to have value, the page will remain available for viewing.

FDA ANNOUNCES TEST RESULTS FROM TEXAS FEED LOT


Today the Food and Drug Administration announced the results of tests taken on feed used at a Texas feedlot that was suspected of containing meat and bone meal from other domestic cattle -- a violation of FDA's 1997 prohibition on using ruminant material in feed for other ruminants. Results indicate that a very low level of prohibited material was found in the feed fed to cattle.

FDA has determined that each animal could have consumed, at most and in total, five-and-one-half grams - approximately a quarter ounce -- of prohibited material. These animals weigh approximately 600 pounds.

It is important to note that the prohibited material was domestic in origin (therefore not likely to contain infected material because there is no evidence of BSE in U.S. cattle), fed at a very low level, and fed only once. The potential risk of BSE to such cattle is therefore exceedingly low, even if the feed were contaminated.

According to Dr. Bernard Schwetz, FDA's Acting Principal Deputy Commissioner, "The challenge to regulators and industry is to keep this disease out of the United States. One important defense is to prohibit the use of any ruminant animal materials in feed for other ruminant animals. Combined with other steps, like U.S. Department of Agriculture's (USDA) ban on the importation of live ruminant animals from affected countries, these steps represent a series of protections, to keep American cattle free of BSE."

Despite this negligible risk, Purina Mills, Inc., is nonetheless announcing that it is voluntarily purchasing all 1,222 of the animals held in Texas and mistakenly fed the animal feed containing the prohibited material. Therefore, meat from those animals will not enter the human food supply. FDA believes any cattle that did not consume feed containing the prohibited material are unaffected by this incident, and should be handled in the beef supply clearance process as usual.

FDA believes that Purina Mills has behaved responsibly by first reporting the human error that resulted in the misformulation of the animal feed supplement and then by working closely with State and Federal authorities.

This episode indicates that the multi-layered safeguard system put into place is essential for protecting the food supply and that continued vigilance needs to be taken, by all concerned, to ensure these rules are followed routinely.

FDA will continue working with USDA as well as State and local officials to ensure that companies and individuals comply with all laws and regulations designed to protect the U.S. food supply.


http://www.fda.gov/bbs/topics/NEWS/2001/NEW00752.html


WE know what happens to most stumbling and staggering suspect mad cows in TEXAS too. THERE tissue samples either sit up on a shelf for 7+ months waiting for everyone to forget about, OR ;


FDA Statement
FOR IMMEDIATE RELEASE
Statement
May 4, 2004
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

Statement on Texas Cow With Central Nervous System Symptoms
On Friday, April 30 th , the Food and Drug Administration learned that a cow with central nervous system symptoms had been killed and shipped to a processor for rendering into animal protein for use in animal feed.

FDA, which is responsible for the safety of animal feed, immediately began an investigation. On Friday and throughout the weekend, FDA investigators inspected the slaughterhouse, the rendering facility, the farm where the animal came from, and the processor that initially received the cow from the slaughterhouse.

FDA's investigation showed that the animal in question had already been rendered into "meat and bone meal" (a type of protein animal feed). Over the weekend FDA was able to track down all the implicated material. That material is being held by the firm, which is cooperating fully with FDA.

Cattle with central nervous system symptoms are of particular interest because cattle with bovine spongiform encephalopathy or BSE, also known as "mad cow disease," can exhibit such symptoms. In this case, there is no way now to test for BSE. But even if the cow had BSE, FDA's animal feed rule would prohibit the feeding of its rendered protein to other ruminant animals (e.g., cows, goats, sheep, bison).

FDA is sending a letter to the firm summarizing its findings and informing the firm that FDA will not object to use of this material in swine feed only. If it is not used in swine feed, this material will be destroyed. Pigs have been shown not to be susceptible to BSE. If the firm agrees to use the material for swine feed only, FDA will track the material all the way through the supply chain from the processor to the farm to ensure that the feed is properly monitored and used only as feed for pigs.

To protect the U.S. against BSE, FDA works to keep certain mammalian protein out of animal feed for cattle and other ruminant animals. FDA established its animal feed rule in 1997 after the BSE epidemic in the U.K. showed that the disease spreads by feeding infected ruminant protein to cattle.

Under the current regulation, the material from this Texas cow is not allowed in feed for cattle or other ruminant animals. FDA's action specifying that the material go only into swine feed means also that it will not be fed to poultry.

FDA is committed to protecting the U.S. from BSE and collaborates closely with the U.S. Department of Agriculture on all BSE issues. The animal feed rule provides crucial protection against the spread of BSE, but it is only one of several such firewalls. FDA will soon be improving the animal feed rule, to make this strong system even stronger.

####


http://www.fda.gov/bbs/topics/news/2004/NEW01061.html


WE know now, and we knew decades ago, that 5.5 grams of suspect feed in TEXAS was enough to kill 100 cows.


look at the table and you'll see that as little as 1 mg (or 0.001 gm) caused 7% (1 of 14) of the cows to come down with BSE;


Risk of oral infection with bovine spongiform encephalopathy agent in primates

Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog, Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia, Nathalie Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-Philippe Deslys
Summary The uncertain extent of human exposure to bovine spongiform encephalopathy (BSE)--which can lead to variant Creutzfeldt-Jakob disease (vCJD)--is compounded by incomplete knowledge about the efficiency of oral infection and the magnitude of any bovine-to-human biological barrier to transmission. We therefore investigated oral transmission of BSE to non-human primates. We gave two macaques a 5 g oral dose of brain homogenate from a BSE-infected cow. One macaque developed vCJD-like neurological disease 60 months after exposure, whereas the other remained free of disease at 76 months. On the basis of these findings and data from other studies, we made a preliminary estimate of the food exposure risk for man, which provides additional assurance that existing public health measures can prevent transmission of BSE to man.


snip...


BSE bovine brain inoculum

100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mg

Primate (oral route)* 1/2 (50%)

Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%) 1/15 (7%)

RIII mice (icip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%)

PrPres biochemical detection   

The comparison is made on the basis of calibration of the bovine inoculum used in our study with primates against a bovine brain inoculum with a similar PrPres concentration that was

inoculated into mice and cattle.8 *Data are number of animals positive/number of animals surviving at the time of clinical onset of disease in the first positive animal (%). The accuracy of

bioassays is generally judged to be about plus or minus 1 log. icip=intracerebral and intraperitoneal.

Table 1: Comparison of transmission rates in primates and cattle infected orally with similar BSE brain inocula


Published online January 27, 2005

http://www.thelancet.com/journal/journal.isa

It is clear that the designing scientists must

also have shared Mr Bradley’s surprise at the results because all the dose

levels right down to 1 gram triggered infection.


http://www.bseinquiry.gov.uk/files/ws/s145d.pdf


2

6. It also appears to me that Mr Bradley’s answer (that it would take less than say 100

grams) was probably given with the benefit of hindsight; particularly if one

considers that later in the same answer Mr Bradley expresses his surprise that it

could take as little of 1 gram of brain to cause BSE by the oral route within the

same species. This information did not become available until the "attack rate"

experiment had been completed in 1995/96. This was a titration experiment

designed to ascertain the infective dose. A range of dosages was used to ensure

that the actual result was within both a lower and an upper limit within the study

and the designing scientists would not have expected all the dose levels to trigger

infection. The dose ranges chosen by the most informed scientists at that time

ranged from 1 gram to three times one hundred grams. It is clear that the designing

scientists must have also shared Mr Bradley’s surprise at the results because all the

dose levels right down to 1 gram triggered infection.


http://www.bseinquiry.gov.uk/files/ws/s147f.pdf


Re: BSE .1 GRAM LETHAL NEW STUDY SAYS via W.H.O. Dr Maura Ricketts

[BBC radio 4 FARM news]

http://www.maddeer.org/audio/BBC4farmingtoday2_1_03.ram

http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm


2) Infectious dose:

To cattle: 1 gram of infected brain material (by oral ingestion)

http://www.inspection.gc.ca/english/sci/bio/bseesbe.shtml


SADLY, DEC 2005 SHOWS THAT WE STILL HAVE A SERIOUS PROBLEM WITH BSE/TSE MAD COW DISEASE FEED

GAO


GAO-06-157R FDA Feed Testing Program

October 11, 2005


SNIP...FULL TEXT 29 PAGES ;


http://www.gao.gov/new.items/d06157r.pdf


Mad Cow Disease: An Evaluation of a Small Feed Testing Program FDA Implemented in 2003 With Recommendations for Making the Program a Better Oversight Tool. GAO-06-157R, October 11

http://www.gao.gov/cgi-bin/getrpt?GAO-06-157R


CVM Update
November 2005 Update on Feed Enforcement Activities to Limit the Spread of BSE

To help prevent the establishment and amplification of BSE through feed in the United States, FDA implemented a final rule that prohibits the use of most mammalian protein in feeds for ruminant animals. This rule, Title 21 Part 589.2000 of the Code of Federal Regulations, here called the Ruminant Feed Ban, became effective on August 4, 1997.

This is an update on FDA enforcement activities regarding the ruminant feed regulation. FDA's CVM has assembled data from the inspections that have been conducted AND whose final inspection report has been recorded in the FDA's inspection database as of November 26, 2005. As of November 26, 2005, FDA had received over 41,000 inspection reports. The majority of these inspections (around 68%) were conducted by State officials under contract to FDA, with the remainder conducted by FDA officials.

Inspections conducted by FDA or State investigators are classified to reflect the compliance status at the time of the inspection based upon the objectionable conditions documented. These inspection conclusions are reported as Official Action Indicated (OAI), Voluntary Action Indicated (VAI), or No Action Indicated (NAI).

An OAI inspection classification occurs when significant objectionable conditions or practices were found and regulatory sanctions are warranted in order to address the establishment's lack of compliance with the regulation. An example of an OAI inspection classification would be findings of manufacturing procedures insufficient to ensure that ruminant feed is not contaminated with prohibited material. Inspections classified with OAI violations will be promptly re-inspected following the regulatory sanctions to determine whether adequate corrective actions have been implemented.

A VAI inspection classification occurs when objectionable conditions or practices were found that do not meet the threshold of regulatory significance, but do warrant advisory actions to inform the establishment of findings that should be voluntarily corrected. Inspections classified with VAI violations are more technical violations of the Ruminant Feed Ban. These include provisions such as minor recordkeeping lapses and conditions involving non-ruminant feeds.

An NAI inspection classification occurs when no objectionable conditions or practices were found during the inspection or the significance of the documented objectionable conditions found does not justify further actions.

The results to date are reported here both by “segment of industry” and “in total”. NOTE – A single firm can operate as more than one firm type. As a result, the categories of the different industry segments are not mutually exclusive.

RENDERERS

These firms are the first to handle and process (i.e., render) animal proteins and to send these processed materials to feed mills and/or protein blenders for use as a feed ingredient.

Number of active firms whose initial inspection has been reported to FDA – 274

Number of active firms handling materials prohibited from use in ruminant feed – 185 (68% of those active firms inspected)

Of the 185 active firms handling prohibited materials, their most recent inspection revealed that:

1 firm (0.5%) was classified as OAI

11 firms (5.9%) were classified as VAI

LICENSED FEED MILLS

FDA licenses these feed mills to produce medicated feed products. The license is required to manufacture and distribute feed using certain potent drug products, usually those requiring some pre-slaughter withdrawal time. This licensing has nothing to do with handling prohibited materials under the feed ban regulation. A medicated feed license from FDA is not required to handle materials prohibited under the Ruminant Feed Ban.

Number of active firms whose initial inspection has been reported to FDA – 1,079

Number of active firms handling materials prohibited from use in ruminant feed – 426 (39% of those active firms inspected)

Of the 426 active firms handling prohibited materials, their most recent inspection revealed that:

0 firm (0%) was classified as OAI

8 firms (1.9%) were classified as VAI

FEED MILLS NOT LICENSED BY FDA

These feed mills are not licensed by the FDA to produce medicated feeds.

Number of active firms whose initial inspection has been reported to FDA – 5,165

Number of active firms handling materials prohibited from use in ruminant feed – 2,036 (39% of those active firms inspected)

Of the 2,036 active firms handling prohibited materials, their most recent inspection revealed that:

2 firms (0.1%) were classified as OAI

24 firms (1.2%) were classified as VAI

PROTEIN BLENDERS

These firms blend rendered animal protein for the purpose of producing quality feed ingredients that will be used by feed mills.

Number of active firms whose initial inspection has been reported to FDA -- 340

Number of active firms handling materials prohibited from use in ruminant feed – 147 (43% of those active firms inspected)

Of the 147 active firms handling prohibited materials, their most recent inspection revealed that:

0 firms (0%) were classified as OAI

7 firms (4.8%) were classified as VAI

RENDERERS, FEED MILLS, AND PROTEIN BLENDERS

This category includes only those firms that actually use prohibited material to manufacture, process, or blend animal feed or feed ingredients.

Number of active renderers, feed mills, and protein blenders whose initial inspection has been reported to FDA – 6,576

Number of active renderers, feed mills, and protein blenders processing with prohibited materials – 539 (8.2% of those active firms inspected)

Of the 539 of active renderers, feed mills, and protein blenders processing with prohibited materials, their most recent inspection revealed that:

3 firms (0.6%) were classified as OAI

23 firms (4.3%) were classified as VAI

OTHER FIRMS INSPECTED

Examples of such firms include ruminant feeders, on-farm mixers, pet food manufacturers, animal feed salvagers, distributors, retailers, and animal feed transporters.

Number of active firms whose initial inspection has been reported to FDA – 13,477

Number of active firms handling materials prohibited from use in ruminant feed – 3,748 (28% of those active firms inspected)

Of the 3,748 active firms handling prohibited materials, their most recent inspection revealed that:

8 firms (0.2%) were classified as OAI

95 firms (2.5%) were classified as VAI

TOTAL FIRMS

Note that a single firm can be reported under more than one firm category; therefore, the summation of the individual OAI/VAI firm categories will be more than the actual total number of OAI/VAI firms, as presented below.

Number of active firms whose initial inspection has been reported to FDA – 16,476

Number of active firms handling materials prohibited from use in ruminant feed – 4,553 (27% of those active firms inspected)

Of the 4,553 active firms handling prohibited materials, their most recent inspection revealed that:

9 firms (0.2%) were classified as OAI

107 firms (2.4%) were classified as VAI


--------------------------------------------------------------------------------

Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm


http://www.fda.gov/cvm/5580.htm


[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 ;

snip...FULL TEXT ;


http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf


Importation of Whole Cuts of Boneless Beef from Japan [Docket No. 05-004-1] RIN 0579-AB93 TSS SUBMISSION


http://docket.epa.gov/edkfed/do/EDKStaffItemDetailView?objectId=090007d480993808


http://docket.epa.gov/edkfed/do/EDKStaffAttachDownloadPDF?objectId=090007d480993808


http://docket.epa.gov/edkfed/do/EDKStaffCollectionDetailView?objectId=0b0007d48096b40d


========================================================

========================================================

OLD TSS SUBMISSIONS;


Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS (comment submission)

https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?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?OpenDocument&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


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 Management Docket: 96N-0417 - Current Good Manufacturing Practice
in Manufacturing, Packing, or Holding Dietary Ingredients a
Comment Number: EC -2
Accepted - Volume 7

http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm


[PDF] Appendices to PL107-9 Inter-agency Working Group Final Report 1-1
File Format: PDF/Adobe Acrobat - View as HTML
Agent, Weapons of Mass Destruction Operations Unit Federal Bureau of
those who provided comments in response to Docket No. ...
Meager 8/18/01 Terry S. Singeltary Sr ...


http://www.aphis.usda.gov/lpa/pubs/pubs/PL107-9_Appen.pdf

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

# Docket No: 02-088-1 RE-Agricultural Bioterrorism Protection Act of
2002; [TSS SUBMISSION ON POTENTIAL FOR BSE/TSE & FMD 'SUITCASE BOMBS'] -
TSS 1/27/03 (0)

Docket Management

Docket: 02N-0276 - Bioterrorism Preparedness; Registration of Food Facilities, Section 305
Comment Number: EC-254 [TSS SUBMISSION]

http://www.fda.gov/ohrms/dockets/dockets/02n0276/02N-0276-EC-254.htm


Dockets Entered On October 2, 2003 Table of Contents, Docket #,
Title, 1978N-0301,

OTC External Analgesic Drug Products, ... EMC 7, Terry S. Singeltary Sr.
Vol #: 1, ...

http://www.fda.gov/ohrms/dockets/dailys/03/oct03/100203/100203.htm


Daily Dockets Entered on 02/05/03

DOCKETS ENTERED on 2/5/03. ... EMC 4 Terry S. Singeltary Sr. Vol#: 2.
... Vol#: 1.

03N-0009 Federal Preemption of State & Local Medical Device Requireme. ...


http://www.fda.gov/ohrms/dockets/dailys/03/Feb03/020503/020503.htm


Docket Management

Docket: 02N-0370 - Neurological Devices; Classification of Human Dura Mater

Comment Number: EC -1

Accepted - Volume 1


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be11.html


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004bdfe.html


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004bdfc.html


Daily Dockets - 04/10/03

... 00D-1662 Use of Xenotransplantation Products in Humans.
EMC 98 Terry S. Singeltary Sr. Vol#: 3. 01F ...
http://www.fda.gov/ohrms/dockets/dailys/03/Apr03/041003/041003.htm - 05-20-2003
- Cached


2003D-0186
Guidance for Industry: Use of Material From Deer and Elk In Animal Feed

EMC 1
Terry S. Singeltary Sr.
Vol #:
1

http://www.fda.gov/ohrms/dockets/dailys/03/Jun03/060903/060903.htm


2003D-0186
Guidance for Industry: Use of Material From Deer and Elk In Animal Feed


EMC 7
Terry S. Singeltary Sr.
Vol #:
1

2003D-0186
Guidance for Industry: Use of Material From Deer and Elk In Animal Feed


EMC 7
Terry S. Singeltary Sr.
Vol #:
1


http://www.fda.gov/ohrms/dockets/dailys/03/oct03/100203/100203.htm


01N-0423 Substances Prohibited from use in animal food/Feed Ruminant

APE 5 National Renderers Association, Inc. Vol#: 2

APE 6 Animal Protein Producers Industry Vol#: 2

APE 7 Darling International Inc. Vol#: 2

EMC 1 Terry S. Singeltary Sr. Vol#: 3

http://www.fda.gov/ohrms/dockets/dailys/01/Oct01/101501/101501.htm


still disgusted in cold cold Bacliff, Texas, dreaming of the warm Caribbean Isands. take us away...


TSS

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


TSS


----- Original Message -----
From: "Terry S. Singeltary Sr."
To:
Sent: Saturday, December 10, 2005 9:04 PM
Subject: Gov't confirms dead cow in Hokkaido as 21st case of BSE


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

From: TSS ()
Subject: Gov't confirms dead cow in Hokkaido as 21st case of BSE
Date: December 10, 2005 at 6:45 pm PST

Gov't confirms dead cow in Hokkaido as 21st case of BSE


Sunday, December 11, 2005 at 06:40 JST
SAPPORO — Japan's agriculture ministry said Saturday a cow that died on a farm in Chitose, Hokkaido Prefecture, earlier this week had bovine spongiform encephalopathy, the 21st mad cow disease case reported in Japan.

The body of the cow was incinerated and meat from the carcass will not enter the market, the Agriculture, Forestry and Fisheries Ministry said. The Holstein cow, 5 years and 9 months old, was born before the government banned the use of meat-and-bone-meal feed.

© 2005 Kyodo News. All rights reserved. No reproduction or republication without written permission.

http://japantoday.com/e/?content=news&cat=1&id=358092


TSS

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