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From: TSS ()
Release No. 0546.05 Printable version 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. 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. Printable version 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. Printable version 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 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 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 December, 2005 Main Page - BSE 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). 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. 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 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; 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. 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; 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 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. 6.1.1. Definition Category 1 countries are those countries that: * a) have never reported a BSE-case, and where, 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: 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. 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; 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. 6.2.1. Definition Category 2 countries are those countries where: * it is likely that imported commodities were contaminated or infected with a TSE-agent, and/or; 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; 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; 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; 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; 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: 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: 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; 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: 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: 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; 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; 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. 6.3.1. 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; 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. 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 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; 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; 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; 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 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; 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; The rationale for including all TSEs in the exposure assessment is based on a consideration that significant uncertainties remain concerning: * the origin of 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 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; 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; 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 Or: 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; 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; 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: 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 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 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; Animal product * Health of Animals Act - includes cream, eggs, milk, non-fertilized ova and semen; 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); 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. 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; 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 >>>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. <<< 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 http://www.sare.org/htdocs/hypermail/html-home/28-html/0359.html https://web01.aphis.usda.gov/BSEcom.nsf/0/b78ba677e2b0c12185256dd300649f9d?OpenDocument&AutoFramed Yoshifumi Iwamaru, Yuka Okubo, Tamako Ikeda, Hiroko Hayashi, Mori- Priori Disease Research Center, National Institute of Animal Health, 3-1-5 Abstract Bovine spongiform encephalopathy (BSE) is a disease of cattle that causes The specified risk materials (SRM) are tissues potentially carrying BSE The 11th BSE case in Japan was detected in fallen stock surveillance. PrPSc was detected in brain, spinal cord, dorsal root ganglia, trigeminal Our results suggest that the currently accepted definitions of SRM in 179 T. Kitamoto (Ed.) The hardback book title is 'PRIONS' Food and Drug Safety We have to be careful that we don't get so set in the way we do things that Dr. Detwiler: That's on the slaughter. But on the clinical cases, aren't Dr. Keller: Tissues are routinely tested, based on which tissue provides an Dr. Detwiler: That's on the slaughter. But on the clinical cases, aren't 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. ... 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). nothing like 'sound science' in this administration, to hell with human health. 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 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. Statement on Texas Cow With Central Nervous System Symptoms 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. #### 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 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 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. 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. [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 To cattle: 1 gram of infected brain material (by oral ingestion) http://www.inspection.gc.ca/english/sci/bio/bseesbe.shtml GAO October 11, 2005 http://www.gao.gov/cgi-bin/getrpt?GAO-06-157R 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: 03-025IFA 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 ; ======================================================== OLD TSS SUBMISSIONS; https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument 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 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 ... genotype can lead to an alternate phenotype that is indistinguishable from type 2 PrPSc, the commonest _sporadic_ CJD; Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt # Docket No: 02-088-1 RE-Agricultural Bioterrorism Protection Act of Docket Management Docket: 02N-0276 - Bioterrorism Preparedness; Registration of Food Facilities, Section 305 http://www.fda.gov/ohrms/dockets/dockets/02n0276/02N-0276-EC-254.htm OTC External Analgesic Drug Products, ... EMC 7, Terry S. Singeltary Sr. http://www.fda.gov/ohrms/dockets/dailys/03/oct03/100203/100203.htm DOCKETS ENTERED on 2/5/03. ... EMC 4 Terry S. Singeltary Sr. Vol#: 2. 03N-0009 Federal Preemption of State & Local Medical Device Requireme. ... Docket: 02N-0370 - Neurological Devices; Classification of Human Dura Mater Comment Number: EC -1 Accepted - Volume 1 ... 00D-1662 Use of Xenotransplantation Products in Humans. EMC 1 http://www.fda.gov/ohrms/dockets/dailys/03/Jun03/060903/060903.htm 2003D-0186 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 #################### https://lists.aegee.org/bse-l.html #################### From: TSS () Gov't confirms dead cow in Hokkaido as 21st case of BSE 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 #################### https://lists.aegee.org/bse-l.html ####################
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