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From: TSS ()
Subject: USDA FSIS NOTICE 15-05 2-28-05 IMPORTATION OF CANADIAN CATTLE, SHEEP, AND GOATS INTO THE UNITED STATES
Date: March 2, 2005 at 9:59 am PST
-------- Original Message -------- Subject: USDA FSIS NOTICE 15-05 2-28-05 IMPORTATION OF CANADIAN CATTLE, SHEEP, AND GOATS INTO THE UNITED STATES Date: Tue, 1 Mar 2005 14:41:38 -0600 From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy To: BSE-L@LISTSERV.KALIV.UNI-KARLSRUHE.DE ##################### Bovine Spongiform Encephalopathy #####################
UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE WASHINGTON, DC FSIS NOTICE 15-05 2-28-05 IMPORTATION OF CANADIAN CATTLE, SHEEP, AND GOATS INTO THE UNITED STATES I. PURPOSE This notice provides instructions to Food Safety and Inspection Service (FSIS) personnel regarding the receipt, slaughter, and inspection of certain ruminants imported from Canada. Regulatory requirements for the importation of certain Canadian ruminants will begin March 7, 2005, and will apply to cattle, sheep, and goats. As set out in this notice, in certain limited circumstances, if inspection program personnel find that animals that have been delivered to a slaughter plant under the Animal and Plant Health Inspection Service (APHIS) regulations do not comply with those regulations, inspection program personnel are to hold the animals under the Animal Health Protection Act (AHPA), pursuant to the authority delegated by APHIS. II. BACKGROUND On January 4, 2005, APHIS published the final rule, Bovine Spongiform Encephalopathy: Minimal-Risk Regions and Importation of Commodities (70 FR 460 553). This final rule amended APHIS regulations (9 CFR parts 93-96, see Attachment 1) to provide for the importation of certain ruminants, and ruminant products and byproducts from regions that pose a minimal risk of introducing bovine spongiform encephalopathy (BSE) into the United States (U.S.), and designated Canada as the first minimal-risk region. These actions will continue to protect against the introduction of BSE into the U.S. while removing unnecessary prohibitions on the importation of certain commodities from minimal-risk regions for BSE. The rule was promulgated under the AHPA. Only cattle that are less than 30 months of age and sheep and goats that are less than 12 months of age are eligible for importation into the U.S. from Canada and eligible for slaughter. The importation and slaughter of cattle 30 months of age or older or of sheep and goats 12 months of age or older is prohibited. DISTRIBUTION: Inspection Offices; T/A Inspectors; Plant Mgt; TRA; ABB; TSC; Import Offices NOTICE EXPIRES: 3/1/06 OPI: OPPED Animals imported from Canada will go through specific ports of entry as listed in 9 CFR 93.403(b) or as provided for in (9 CFR 93.403(f)). At the port, the APHIS veterinarian reviews documents and inspects the shipment to ensure that it is being imported in compliance with the regulations. The APHIS veterinarian also has the authority to offload animals for verification. Animals shipped directly for slaughter will go to official establishments in sealed trucks, will bear a Canadian ear tag, will be accompanied by VS Form 17-33 and a Canadian Health Certificate, and are to be slaughtered or euthanized within two weeks of entry into the U. S. and are not to leave the official premises. Animals shipped to a feedlot and then to an official establishment for slaughter will bear a Canadian ear tag, and a C?N brand (for cattle), or a C brand (for sheep and goats), and will be accompanied by VS Form 1-27 and a copy of the Canadian Health Certificate, which indicates the age and other descriptive information on each of the animals. A federally accredited veterinarian, state representative, or USDA representative at the feedlot will verify the presence of the Canadian ear tag, appropriate brands, and that cattle, sheep and goats meet all requirements when they go directly to slaughter under seal. Only a USDA representative can break the seal on the truck containing Canadian animals upon arrival at an official establishment (i.e., FSIS inspection program personnel, an APHIS Technician or other APHIS representatives). FSIS strongly recommends that establishments receiving such ruminants implement procedures that ensure that trucks carrying the animals arrive at the establishment when a USDA representative is readily available to promptly break the seals on the truck. These procedures will facilitate prompt unloading of these ruminants and humane handling in connection with slaughter of these ruminants. However, in all cases, the establishment is to ensure that animals are humanely handled in accordance with the Humane Methods of Slaughter Act and 9 CFR part 313. An establishment is to have procedures in place to ensure that animals arriving directly from Canada for immediate slaughter are slaughtered as a group (9 CFR 93. 436(a)(6)). This is not required for animals that arrive at slaughter via a feedlot because they may be separated and sent to different official establishments for slaughter. To facilitate the determination as to whether animals are eligible for slaughter, a prudent establishment should also maintain the identity of the animals from Canada via a feedlot until the marks of inspection are applied. Although there are no new food safety requirements related to the receipt of animals from Canada, FSIS is reiterating that establishments receiving cattle from Canada are subject to the regulations regarding Specified Risk Materials (SRMs) at 9 CFR 310.22. Therefore, in accordance with 9 CFR 310.22(d)(3) an establishment is to evaluate the effectiveness of its procedures for the removal, segregation, and disposition of SRMs (as incorporated into its HACCP plans, Sanitation SOPs, or prerequisite program (9 CFR 310.22(d)(1)) whenever a change occurs that could affect the procedures such as ensuring that the Canadian animals are properly identified. Also, in accordance with 9 CFR 417.4(a)(3), an establishment is to reassess its HACCP system whenever there is a change in raw materials or in the source of raw materials, 2 FSIS NOTICE 15-05 as would be the case here. Therefore, an official establishment that begins to receive eligible cattle from Canada will need to evaluate its SRM procedures, reassess its HACCP system, and incorporate necessary changes. The SRM requirements do not apply to sheep and goats; however, an establishment receiving sheep and goats from Canada is to reassess its HACCP system and ensure that sheep and goats presented for slaughter are less than 12 months of age. Unless the establishment can demonstrate through records or other means that the cattle are less than 30 months of age, FSIS will consider the cattle to be 30 months of age or older (9 CFR 310.22(e)) and therefore ineligible for slaughter. FSIS will also consider sheep and goats to be 12 months of age or older unless the establishment can demonstrate through records or other means that the sheep or goats are less than 12 months of age. III. DEFINITION AND FORMS Hold: For purposes of this notice, when cattle 30 months of age or older or sheep and goats 12 months of age or older arrive at an official establishment, or when the proper documentation (i.e., seals, forms, tags) is not present or accurate, inspection program personnel are to ensure that the animals in question are segregated and are not moved to slaughter or outside the official premises (see the AHPA and the regulations at 9 CFR 93-96). In all cases, animals in question will be moved off of the means of transportation, into an area or pen at the official establishment, and treated under humane conditions. To execute the holding of animals and to restrict their movement under the AHPA, inspection program personnel will use a U.S. Retained tag applied to the pens containing the affected animals. In addition to Canadian Health Certificates, the Veterinary Services (VS) APHIS forms that must accompany shipments of animals from Canada are as follows: For Animals from Canada for Immediate Slaugther: VS Form 17-33, Animals Imported for Immediate Slaughter For Animals from Canada Shipped to a Designated/Approved Feedlot in the U.S. Before Shipment to an Official Establishment: VS Form 1-27, Permit for Movement of Restricted Animals IV. INSPECTION PROGRAM PERSONNEL RESPONSIBILITIES REGARDING HACCP SYSTEMS A. Upon receipt of this notice Public Health Veterinarians (PHVs) are to have an awareness meeting at establishments that may choose to receive animals from Canada. PHVs are to inform the establishment that if it decides to receive animals from Canada it will need to reassess its HACCP system as set out in 9 CFR 417.4(a)(3) because the receipt of the animals, as a new source of raw materials, is a change at the establishment that may affect the HACCP system. The establishment needs to be 3 separately approved by APHIS to receive these restricted Canadian animals and can obtain a list of plants approved to handle animals for immediate slaughter at: www.aphis.usda.gov/vs/ncie. NOTE: If an establishment plans to receive bison from Canada, inspection program personnel are to contact the Technical Service Center. B. In a memorandum of interview, the PHV is to document who was present at the initial awareness meeting, the date and time of the meeting, what was discussed, and any documents that were shared with management. Inspection program personnel are to maintain a copy of the memorandum in the official government file and provide a copy to the plant management. C. After the establishment has performed its reassessment, PHVs are to verify into which programs (i.e., HACCP plans, Sanitation SOPs, or prerequisite programs) the establishment incorporated any procedures adopted as a result of its reassessment. PHVs are to verify that the establishment has appropriately addressed in its HACCP system the receipt of animals from Canada to ensure that animals ineligible for slaughter are not slaughtered. PHVs also are to verify, consistent with the regulations and current policy, that for cattle that are slaughtered, the SRMs are properly segregated, removed, and disposed (See 9 CFR 310.22, FSIS Notice 9-04, Verification Instructions For The Interim Final Rule Regarding Specified Risk Materials (SRMs) In Cattle, and FSIS Notice 10-04, Questions and Answers, Regarding the Age Determination of Cattle and Sanitation). D. Inspection program personnel will verify the execution of the establishments food safety systems and will issue a Noncompliance Record and take the necessary enforcement action if an establishment fails to follow its written procedures as incorporated into its food safety systems, (e.g., fails to ensure that only animals of a specified age are presented for slaughter). (See FSIS Directive 5000.1, Revision 1, FSIS Notices 9-04 and 10-04, and 9 CFR 417.3 and 416.15.) On-line inspection program personnel are to notify the PHV or, if unavailable, other off-line inspection program personnel if they have reason to believe that an establishment's SRM control program, or the establishments segregation of Canadian animals, may be ineffective (for example, when repeated presentation of contaminated cattle heads or carcasses for post-mortem inspection at the rail and head inspection station indicates failure to control SRM contamination, or Canadian animals for direct slaughter are not slaughtered as a group). The PHV or other off-line personnel will perform the appropriate HACCP or Sanitation SOP procedures to evaluate the process. V. VERIFICATION ACTIVITIES WHEN ANIMALS FROM CANADA ARRIVE AT OFFICIAL ESTABLISHMENTS A. Animals Shipped From Canada For Immediate Slaughter Inspection program personnel will perform the following activities when animals are shipped from Canada for immediate slaughter. 1. Inspection program personnel will verify that a seal is present and intact on the shipping truck. The vehicle will be sealed with either a Canadian government seal, 4 FSIS NOTICE 15-05 or a U.S. government seal. If the seal on the truck is missing or broken, or otherwise tampered with, inspection program personnel are to: a. have all animals unloaded from the truck onto the official premises, b. institute a hold on the animals in the pen and restrict movement using a U.S. Retained tag applied to the pens, c. promptly contact the District Office so that it can notify the APHIS AVIC with jurisdiction in the state where the official establishment is located. (See http://www.aphis.usda.gov/vs/area_offices.htm for addresses of AVICs). 2. The AVIC will directly notify the establishment on disposition of the affected animals. An establishment may have a letter on file from the AVIC regarding the disposition of animals from Canada, and the establishment is to dispose of the animals in accordance with the letter. NOTE: Inspection program personnel are to consider Canadian animals that are on the truck and that are nonambulatory-disabled or dead on arrival to be presented for inspection. Inspection program personnel are to verify that they are handled humanely, euthanized (where applicable), entered into e-ADRS, and, for cattle, sampled for the BSE surveillance program as set out in FSIS Notice 28-04 and 29-04. 3. After verifying that the truck is properly sealed, inspection program personnel are to break the seal. Only a USDA representative can break the seal on the truck (i.e., FSIS inspection program personnel, an APHIS Technician or other APHIS representatives). 4. Inspection program personnel are to verify that the establishment follows its procedures for immediately off-loading and segregating the entire group of animals onto the official premises. 5. Inspection program personnel are to verify that: a. a VS Form 17-33 and a Canadian Health Certificate are present, b. the establishment follows its procedures to ensure that there are no animals in the group that are not listed on the Health Certificate, and c. the establishment follows its procedures to ensure that the animals listed on the VS Form 17-33 are tagged as follows: i. bovine are to be individually identified by an official Canadian Food Inspection Agency (CFIA) ear tag, and ii sheep and goats are to be individually identified by an official CFIA ear tag. 5 NOTE: Animals may arrive with forms in addition to the VS Form 17-33 and Canadian Health Certificate. Inspection program personnel are to maintain copies of any additional documents in the inspection file, however there are no verification or distribution activities that inspection program personnel are to perform related to these other documents. 6. Inspection program personnel are to institute a hold on the animals in question with a U.S. Retained tag applied to the pens and promptly contact the District Office so that it can notify the APHIS AVIC if: a. the VS 17-33 or the Canadian Health Certificate is not present, b. the establishment has found animals that are not listed on the Health Certificate, c. the establishment has failed to follow its procedures referenced in paragraph V. A. 4 of this notice. 7. The AVIC will directly notify the establishment of subsequent actions. An establishment may have a letter on file from the AVIC regarding the disposition of any ineligible animals from Canada, and the establishment is to dispose of the ineligible animals in accordance with the letter. 8. Inspection program personnel are to verify that the establishment takes the appropriate action as set out its procedures for the removal, segregation, and disposition of SRMs and as incorporated into its HACCP system. B. Animals from Canada Shipped to a Feedlot into the U.S. before Shipment to an Official Establishment 1. Inspection program personnel will follow the instructions in section V. A. 1. through 4. 2. Inspection program personnel are to verify that: a. VS Forms 1-27 and a Canadian Health Certificates accompany the shipment, and b. the establishment follows its procedures to ensure that there are no animals in the group that are not listed on the VS Forms 1-27. NOTE: Due to the fact that Canadian origin animals may leave the feedlot at different times, the Canadian Health Certificates may have more animals listed than on the VS Forms 1-27, and there may be more than one Canadian Health Certificate attached to the VS Forms 1-27. Inspection program personnel are to maintain copies of any additional documents in the inspection file, however there are no verification or distribution activities that inspection program personnel are to perform related to these 6 FSIS NOTICE 15-05 other documents. 3. Inspection program personnel are to institute a hold on the animals in question with a U.S. Retained tag applied to the pens and promptly contact the District Office so that it can notify the APHIS AVIC if: a. The VS Forms 1-27 or the Canadian Health Certificates is not present, b. the establishment has found animals that are not listed on the VS Form 1-27, or c. the establishment has failed to follow its procedures that are referenced in paragraph V. B. 2. b. of this notice. 4. The AVIC will directly notify the establishment of subsequent actions. An establishment may have a letter on file from the AVIC regarding the disposition of any ineligible animals from Canada, and the establishment is to dispose of the ineligible animals in accordance with the letter. 5. Inspection program personnel are to verify that the establishment takes the appropriate action as set out its procedures for the removal, segregation, and disposition of SRMs and as incorporated into its HACCP system. VI. ANTEMORTEM AND POSTMORTEM VERIFICATION ACTIVITIES A. Antemortem Inspection 1. Inspection program personnel are to conduct routine antemortem inspection, after the establishment has completed the procedures it has in place for segregating cattle and as incorporated into its HACCP system. (See FSIS Notice 7-04, and 9-04). As instructed in FSIS Notice 10-04: a. while performing verification activities related to the age of cattle, inspection program personnel are to verify, in establishments using documentation, that the records support the establishments determinations. If the records do not support the determinations, inspection program personnel are to verify that the establishment takes the appropriate corrective action under 9 CFR 417.3(a) or (b). NOTE: Hands-on dentition examinations are not to be used to determine the adequacy of the documentation. If a PHV is unsure as to whether the plants procedures are adequate, he or she is to contact the Technical Service Center for technical assistance. b. while performing verification activities related to the age of cattle, inspection program personnel are to verify, in establishments using dentition, that the establishments determinations, which are typically made at postmortem, are consistent with the guidance provided in FSIS Notice 5-04. If the determinations made by the establishment are not consistent with the guidelines, inspection program personnel are to verify that the establishment takes the appropriate corrective action under 9 CFR 7 417.3(a) or (b). NOTE: For sheep and goats, inspection program personnel are to conduct routine antemortem inspection, after the establishment has completed the procedures it has in place for segregating the animals and as incorporated into its HACCP system. Inspection program personnel are to follow the instructions above related to documentation to verify that such animals are not 12 months of age or older. In an establishment slaughtering sheep and goats that are using dentition, inspection program personnel are to verify the establishments determinations, which are typically made at postmortem are consistent with the permanent incisor eruption as shown on the Technical Service Center Website: www.fsis.usda.gov/ofo/tsc. 2. For ruminants arriving under VS Form 17-33, inspection program personnel are to verify that the establishment is properly executing its procedures to ensure that the cattle, sheep, and goats are slaughtered as a group until the marks of inspection are applied. NOTE: If animals are pregnant, the collection of fetal bovine serum is prohibited and is to be dispose of as set out by the AVIC. (See 3 and 4 below). 3. If an establishment fails to prevent Canadian origin animals that are ineligible for slaughter from being presented for slaughter, PHVs are to institute a hold on affected animals using a U.S. retained tag applied to the pens and promptly contact the District Office so that it can notify the APHIS AVIC. 4. The AVIC will directly notify the establishment of subsequent actions. An establishment may have a letter on file from the AVIC regarding the disposition of any ineligible animals from Canada, and the establishment is to dispose of the ineligible animals in accordance with the letter. 5. Inspection program personnel are to verify that the establishment takes the appropriate action as set out its procedures for the removal, segregation, and disposition of SRMs and as incorporated into its HACCP system. 6. For antemortem condemnations on eligible animals from Canada under 9 CFR Part 309, inspection program personnel are to continue to follow current regulations and directives. 7. If inspection program personnel observe any animal with a C?N brand (for cattle), and C brand (for sheep and goats) or CFIA ear tag while performing antemortem inspection on any domestic cattle lots, they are to institute a hold on the animals using a U.S. Retained tag applied to the pens and the PHV is to contact the District Office so that it can notify the APHIS AVIC. The AVIC will directly notify the establishment of subsequent actions and inspection program personnel are to verify that the establishment takes the appropriate action as set out its procedures for the removal, segregation, and disposition of SRMs and as incorporated into its HACCP system. B. Postmortem Inspection 8 FSIS NOTICE 15-05 1. Off-line inspection program personnel are to verify execution of establishment programs for ensuring that animals ineligible for slaughter were not slaughtered and that eligible animals direct from Canada are slaughtered as a group until the marks of inspection are applied. 2. If an establishment slaughters animals that are ineligible for slaughter, PHVs are to institute a hold on the carcass and parts with a U.S. Retained tag. PHVs are to promptly contact the District Office so that it can notify the AVIC. Inspection program personnel are to verify that the establishment takes the appropriate action as set out its procedures for the removal, segregation, and disposition of SRMs and as incorporated into its HACCP system. 3. PHVs are to collect and hold for the AVIC all means of identification (i.e., eartags, the VS-Form 1-27, and Health Certificate) and evidence regarding the age of the animals (i.e., a picture, when a camera is available, or a written description regarding a dentition finding). 4. The AVIC will contact the establishment, under its obligations as an establishment approved by APHIS to receive these animals, to ensure specific disposition and disposal requirements. An establishment may have a letter on file from the AVIC regarding the disposition of any ineligible animals (including a fetus) from Canada, and the establishment is to dispose of the ineligible animals in accordance with the letter. 5. If PHVs have concerns regarding the establishments disposal, or failure to dispose of carcasses or parts of ineligible animals, they are to notify the District Office so that it can notify the APHIS AVIC. The AVIC will initiate any necessary investigation. 6. Any SRMs will be disposed in accordance with plant programs under 9 CFR 310.22. 7. For postmortem condemnations of eligible Canadian animals under 9 CFR Part 310, inspection program personnel are to continue to follow current regulations and directives. No special reporting of any condemnations on eligible animals is required. VII. COMPLETING AND DISTRIBUTING FORMS A. For animals from Canada that were shipped for immediate slaughter After the slaughter of the shipment of animals, inspection program personnel are to: 1. sign and date the VS Form 17-33, (See Outlook Public Folders/All Public Folders/OFO/Technical Service Center/BSE Training Info for additional information about the VS Form 17-33), 2. maintain a copy of the VS Form 17-33 and the Canadian Health Certificate and 9 any other documentation arriving with the shipment in the inspection file, and 3. send a copy of the signed and dated VS Form 17-33 (Part 3) to the port of entry as written on the form. B. For animals from Canada that were shipped to a feedlot before shipment to an official establishment After the slaughter of the shipment of animals, inspection program personnel are to: 1. sign and date the VS Form 1-27, (See Outlook Public Folders/All Public Folders/OFO/Technical Service Center/BSE Training Info for additional information about the VS Form 1-27), 2. maintain a copy of the VS Form 1-27 and the Canadian Health Certificate (see above) and any other documentation arriving with the shipment in the inspection file, and 3. send a copy of the signed and dated VS Form 1-27 (Part 2), to the APHIS AVIC in the state where the designated feedlot is located. Direct technical questions regarding this notice to the Technical Service Center at 1-800-233-3935. Direct other questions through supervisory channels. Philip S. Derfler /s/ Assistant Administrator Office of Policy, Program, and Employee Development 10 http://www.fsis.usda.gov/OPPDE/rdad/FSISNotices/15-05.pdf Working Group Report on the Assessment of the Geographical BSE-Risk (GBR) of CANADA snip... Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the Geographical BSE Risk of Canada - 11 - snip... - 2 - 2. EXTERNAL CHALLENGES 2.1 Import of cattle from BSE-Risk2 countries An overview of the data on live cattle imports is presented in table 1 and is based on data as provided in the country dossier (CD) and corresponding data on relevant exports as available from BSE risk countries that exported to Canada. Only data from risk periods are indicated, i.e. those periods when exports from a BSE risk country already represented an external challenge, according to the SSC opinion on the GBR (SSC July 2000 and updated January 2002). " According to the CD, 231 cattle were imported from UK during the years 1980 to 1990 and no cattle imports from UK were recorded after 1990. " According to Eurostat, altogether 198 cattle have been imported from the UK during the years 1980 to 1990, Additionally 500 were recorded in 1993; this import is 1 For the purpose of the GBR assessment the abbreviation MBM refers to rendering products, in particular the commodities Meat and Bone Meal as such; Meat Meal; Bone Meal; and Greaves. With regard to imports it refers to the customs code 230110 flours, meals and pellets, made from meat or offal, not fit for human 2 BSE-Risk countries are all countries already assessed as GBR III or IV or with at least one confirmed Annex to the EFSA Scientific Report (2004) 2, 1-14 on the Assessment of the Geographical BSE Risk of Canada - 3 - mentioned in Eurostat and the updated UK export statistic as male calves, but not mentioned in the original UK export statistics. According to the CD, detailed investigations were carried out and it is very unlikely that the 500 calves have been imported. Therefore, they were not taken into account. " According to the CD, in 1990 all cattle imported from UK and Ireland since 1982 were placed in a monitoring program. " Following the occurrence of the BSE index case in 1993 (imported from UK in 1987 at the age of 6 months), an attempt was made to trace all other cattle imported from UK between 1982 and 1990. " Of the 231 cattle imported from the UK between 1980 and 1990, 108 animals had been slaughtered and 9 had died. From the remaining, 37 were exported, 76 were sent to incineration and one was buried; these were not entering the rendering system and therefore not taken into account. " According to the CD, 16 cattle were imported from Ireland (according to Eurostat 20), of which 9 were slaughtered, 3 died. The remaining 4 were incinerated and did therefore not enter the rendering system. According to the CD, the 6 animals which were imported in 1990 according to Eurostat, were never imported. " Moreover 22 cattle have been imported from Japan (through USA), of which 4 were exported (excluded from the table) and 14 were destroyed and therefore not entering the rendering system, 4 were slaughtered. " Of 28 imported bovines from Denmark, 1 was destroyed and 1 was exported. Of the 19 buffalos imported in 2000, 1 was incinerated and the others were ordered to be destroyed. " Additionally in total 264 cattle according to the CD (276 according to other sources) were imported from Austria, France, Germany, Hungary, Italy, The Netherlands and Switzerland. " The numbers imported according to the CD and Eurostat are very similar. Some discrepancies in the year of import can be explained by an extended quarantine; therefore it is likely that imports according to Eurostat in 1980 and imports according to the CD in 1981 are referring to the same animals. " Additionally, between 16.000 and 340.000 bovines have annually been imported from US, almost all are steers and heifers. In total, between 1981 and 2003, according to the CD more than 2.3 million, according to other sources 1.5 million cattle have been imported. " According to the CD, feeder/slaughter cattle represent typically more than 90% of the imported cattle from the USA; therefore, only 10% of the imported cattle have been taken into account. snip... Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the Geographical BSE Risk of Canada - 5 - 2.2 Import of MBM or MBM-containing feedstuffs from BSE-Risk countries An overview of the data on MBM imports is presented in table 2 and is based on data provided in the country dossier (CD) and corresponding data on relevant exports as available from BSE risk countries that exported to Canada. Only data from risk periods are indicated, i.e. those periods when exports from a BSE risk country already represented an external challenge, according to the SSC opinion on the GBR (SSC, July 2000 and updated January 2002). According to the CD, no imports of MBM took place from UK since 1978 (initially because of FMD regulations). " According to Eurostat data, Canada imported 149 tons MBM from the UK in the period of 1993 to 2001. According to up-dated MBM statistics from UK (August 2001) no mammalian MBM was exported to Canada from 1993 1996. As it was illegal to export mammalian meat meal, bone meal and MBM from UK since 27/03/1996, exports indicated after that date should only have included nonmammalian MBM. Therefore, these imports were not taken into account. " According to the CD, imports of MBM have taken place from Denmark, Germany, France, Japan and US. " According to Eurostat Canada imported MBM from Denmark, Belgium, France and Ireland. " According to the CD further investigations concluded that all imported MBM from Denmark consisted of pork and poultry origin and was directly imported for aquaculture, the imported MBM from France was feather meal, the imported MBM from Germany was poultry meal for aquaculture and the imported MBM from Belgium was haemoglobin; therefore these imports were not taken into account. " The main imports of MBM were of US origin, according to the CD around 250.000 tons, according to other sources around 310.000 tons between 1988 and 2003.
snip... Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the Geographical BSE Risk of Canada - 7 - 2.3 Overall assessment of the external challenge The level of the external challenge that has to be met by the BSE/cattle system is estimated according to the guidance given by the SSC in its final opinion on the GBR of July 2000 (as updated in January 2002). Live cattle imports: In total the country imported according to the CD more than 2.3 million, according to other data 1.5 million live cattle from BSE risk countries, of which 231 (CD) respectively 698 (other sources) came from the UK. The numbers shown in table 1 are the raw import figures and are not reflecting the adjusted imports for the assessment of the external challenge. Broken down to 5 year periods the resulting external challenge is as given in table 3. This assessment takes into account the different aspects discussed above that allow to assume that certain imported cattle did not enter the domestic BSE/cattle system, i.e. were not rendered into feed. In the case of Canada, the 500 cattle imported from UK according to Eurostat were not taken into account and it is assumed that all incinerated, buried, exported animals and the animals still alive did not enter the rendering system and were therefore excluded from the external challenge. MBM imports: In total the country imported according to the CD around 300.000 tons, according to other sources nearly 360.000 tons of MBM from BSE risk countries, of which 149 tons came from the UK. The majority consisted of MBM imported from the US. The numbers shown in table 2 are the raw import figures and are not reflecting the adjusted imports for the assessment of the external challenge. Broken down to 5 year periods the resulting external challenge is as given in table 3. This assessment takes into account the different aspects discussed above that allow to assume that certain imported MBM did not enter the domestic BSE/cattle system or did not represent an external challenge for other reasons. As it was illegal to export mammalian meat meal, bone meal and MBM from UK since 27/03/1996, exports indicated after that date should only have included non-mammalian MBM. In the case of Canada all imported MBM from UK, Germany, Belgium, Denmark and France was not taken into account. On the basis of the available information, the overall assessment of the external challenge is as given in table 3 below. Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the Geographical BSE Risk of Canada - 8 - External Challenge experienced by CANADA External challenge Reason for this external challenge Period Overall Level Cattle imports MBM imports Comment 1980 to 1990 Low Low Negligible 1991 to 1995 High Moderate High 1996 to 2000 Extremely high High Extremely high 2001 to 2003 Very high High Very high Table 3: External challenge resulting from live cattle and/or MBM imports from the UK and other BSE risk countries. The challenge level is determined according to the SSC-opinion on the GBR of July 2000 (as updated in January 2002). 3. STABILITY 3.1 Overall appreciation of the ability to avoid recycling of BSE infectivity, should it enter processing Feeding The annual Canadian production of MBM is approximately 575,000 tons of which approx. 40,000 tons are exported each year, mainly to USA. Use of MBM in cattle feed " Before the feed ban, dairy cattle received supplementary feed containing MBM during their productive life (maximum 200-400 g MBM per day). Beef cattle in the western part of the country do not usually receive complementary feed. Beef cattle in the eastern part receive normally no supplement protein but the calves could have access to creep feeds containing MBM, after weaning the ratios may have contained supplemental protein containing MBM (100-400 g per day). " According to the CD, MBM is mainly fed to pigs and poultry and included in pet food. " According to the CD, only a proportion of dairy cattle may have received MBM. Feed bans " Before 1997, there was no legal restriction to include MBM into cattle feed. " An MBM-ban was introduced in August 1997; it is forbidden since to feed mammalian MBM to ruminants except if of pure porcine, equine and non mammalian origin, i.e. in practice a ruminant-to-ruminant ban (RMBM-ban). Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the Geographical BSE Risk of Canada - 9 - Potential for cross-contamination and measures taken against " Cross-contamination in the about 600 feed mills is assumed to be possible as long as cattle and pig feed is produced in the same production lines, and premises. " Cross-contamination during transport is possible, particularly if the same trucks are used for transporting ruminant MBM (RMBM) and non-ruminant MBM (porcine or poultry MBM which still might be included into cattle feed) or for transporting pig/poultry feed and cattle feed. " On-farm cross-contamination is regarded to be possible. " Cross-contamination of cattle feed with RMBM can not be excluded. Hence, as reasonable worst case scenario, it has to be assumed that cattle, in particular dairy cattle, can still be exposed to RMBM and hence to BSE-infectivity, should it enter the feed chain. Control of Feed bans and cross-contamination " With the introduction of the RMBM ban (1997) the feed mills (approximately 600) were checked for compliance with the ban, including good manufacturing practices (GMP) and record keeping, i.e. the separation in production of MBM containing ruminant material (RMBM) from non-ruminant MBM. " The feed mills had previously since 1983 been regularly checked in relation to production of medicated feed. " No examinations are performed to assess cross-contamination with RMBM of the protein (e.g. non ruminant MBM) that enters cattle feed. Differentiation would anyway be difficult. Rendering Raw material used for rendering " Ruminant material is rendered together with material from other species, but according to the CD only in the production of MBM prohibited for use in ruminant feeds. " Slaughter by-products, including specified risk material (SRM) and fallen stock are rendered. " The country expert estimated that 20% of the rendering plants, processing 20% of the total amount of raw material, are connected to slaughterhouses. Their raw material is more than 98 % animal waste from these slaughterhouses while less than 2 % is fallen stock. No estimation was given for the remaining 80% of the rendering capacity. " There are 32 rendering plants of which 3 are processing blood exclusively. Rendering processes " The rendering systems (parameters) were specified for 6 plants producing mixed MBM, none of these fulfilled the 133/20/3 standard. Of these, 5 have dedicated facilities to produce products for use in ruminant feed and products not permitted for use in ruminant feed. " The remaining plants process porcine or poultry material exclusively. SRM and fallen stock " There is an SRM ban for human food in place since 2003. Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the Geographical BSE Risk of Canada " However, SRM are rendered together with other slaughter waste and fallen stock. However, according to the CD, MBM with SRM is not permitted to be fed to ruminants. Conclusion on the ability to avoid recycling " Between 1980 and 1997 the Canadian system would not have been able to avoid recycling of the BSE-agent to any measurable extent. If the BSE-agent was introduced into the feed chain, it could have reached cattle. " Since 1997 this ability gradually improved with the introduction of the ruminant MBM ban and its implementation. " Since cross-contamination cannot be excluded, and as SRM is still rendered by processes unable to significantly reduce BSE-infectivity, the system is still unable to avoid recycling of BSE-infectivity already present in the system or incoming. 3.2 BSE surveillance laboratory tests). i.e. formalin fixation. snip... In 1990, when BSE was made notifiable, this awareness was extended to suspicions of BSE. " Since 1993 the number of brains examined per year did exceed the number recommended by OIE (300 - 336 for countries with a cattle population over 24 months of age of 5.0 to 7.0 Million)
PLEASE NOTE BEFORE GOING ANY FURTHER THAT MOST EVERY COUNTRY THAT WENT BY THOSE SAME OIE BSE GUIDELINES HAVE BSE NOW. THE ONLY REASON IT WAS NOT DETECTED SOONER IN THESE COUNTRIES WERE BECAUSE OF THESE SAME OIE GUIDELINES. SIMPLY PUT, THEY ARE WRONG IN RELATIONS TO TSEs. IT'S NOTHING MORE THAN AN EXCUSE, ONE THAT FLIES ABOUT LIKE A COW WOULD...TSS in all years, except in 1995 (table 4). year 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 samples 225 645 426 269 454 759 940 895 1´020 1´581 3´377 3´361 Table 4: Number of bovine brains annually examined for CNS diseases, including BSE. " According to the CD approx. 98% of the examined cattle were older than 24 months and approx. 90% exhibited neurological symptoms. Although the identification system of Canada does not document the birth date or age of the animals, according to the CD, examination of the dentition is used to ascertain the maturity of the animals. " The list of neurological differential diagnoses for the 754 brains examined in 1997 included encephalitis (70 cases), encephalomalacia (19), hemophilus (7), hemorrhage (2), listeriosis (38), meningoencephalitis (36), rabies (22), tumors (2), other conditions (135) and no significant findings (423). " Compensation is paid for suspect BSE cases as well as for animals ordered to be destroyed (90-95% of market value with a maximum of 2,500 Can$ per cow). " Diagnostic criteria developed in the United Kingdom are followed at ADRI, Nepean. According to the very detailed protocol for the collection, fixation and submission of Bovine Spongiform Encephalopathy (BSE) specimens at abattoirs under inspection by the Canadian Food Inspection Agency, the specimen shall be shipped to National Center for Foreign Animal Disease, Winnipeg, Manitoba. " In 2003, around 3000 animals from risk populations have been tested. " According to the CD, it is aimed to test a minimum of 8000 risk animals (animals with clinical signs consistent with BSE, downer cows, animals died on farm animals diseased or euthanized because of serious illness) in 2004 and then continue to progressively increase the level of testing to 30,000. " In May 2003, Canada reported its first case of domestic BSE. A second case was detected in the US on 23 December 2003 and traced back to Canadian origin. Both were born before the feed ban and originated from Western Canada. 3.3 Overall assessment of the stability For the overall assessment of the stability, the impact of the three main stability factors (i.e. feeding, rendering and SRM-removal) and of the additional stability factor, surveillance, has to be estimated. Again, the guidance provided by the SSC in its opinion on the GBR of July 2000 (as updated January 2002) is applied. Until 1997, it was legally possible to feed ruminant MBM to cattle and a certain fraction of cattle feed (for calves and dairy cattle) is assumed to have contained MBM. Therefore feeding was Not OK. In August 1997 a ruminant MBM ban was introduced but feeding of non-ruminant MBM to cattle remained legal as well as feeding of ruminant MBM to non-ruminant animals. This makes control of the feed ban very difficult because laboratory differentiation between ruminant and non ruminant MBM is difficult if not impossible. Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the Geographical BSE Risk of Canada - 12 - Due to the highly specialised production system in Canada, various mammalian MBM streams can be separated. Such a feed ban would therefore be assessed as "reasonably OK", for all regions where this highly specialised system exists. However, several areas in Canada do have mixed farming and mixed feed mills, and in such regions, an RMBM ban would not suffice. Additionally, official controls for cattle feeds to control for the compliance with the ban were not started until the end of 2003. Thus, for the whole country, the assessment of the feeding after 1997 remains "Not OK". Rendering The rendering industry is operating with processes that are not known to reduce infectivity. It is therefore concluded that the rendering was and is Not OK. SRM-removal SRM and fallen stock were and are rendered for feed. Therefore SRM-removal is assessed as Not OK BSE surveillance Before 1989, the ability of the system to identify (and eliminate) BSE-cases was limited. Since 1990 this ability is improved, thanks to a specific (passive) BSE surveillance. Today the surveillance should be able to detect clinical BSE-cases within the limits set by an essentially passive surveillance system. " Passive surveillance has been carried out since 1990. In 1993 surveillance was intensified and has considerably improved with mandatory reporting and basic compensation ensured, awareness raising measures and education of veterinarians, and a specific BSE-surveillance programme targeting cattle showing clinical signs that could be compatible with BSE. " The initiated introduction of active surveillance should improve the system significantly. Stability of the BSE/cattle system in CANADA over time Stability Reasons Period Level Feeding Rendering SRM removal BSE surveillance 1980 to 2000 Mainly passive 2001 to 2003 Extremely unstable Not OK Not OK Not OK Improving with some testing of risk groups Table 5: Stability resulting from the interaction of the three main stability factors and the BSE surveillance. The stability level is determined according to the SSC-opinion on the GBR of July 2000 (as updated in 2002). Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the Geographical BSE Risk of Canada - 13 - On the basis of the available information, it has to be concluded that the country's BSE/cattle system was extremely unstable until today, i.e., it would have recycled and amplified BSE-infectivity very fast, should it have entered the system. The stability of the BSE/cattle system in Canada overtime is as given in table 5 above. 4. CONCLUSION ON THE RESULTING RISKS 4.1 Interaction of stability and challenges In conclusion, the stability of the Canada BSE/cattle system in the past and the external challenges the system has coped with are summarised in the table 6. INTERACTION OF STABILITY AND EXTERNAL CHALLENGE IN CANADA Period Stability External Challenge Internal challenge 1980 to 1990 Low Unlikely but not excluded 1991 to 1995 High 1996 to 2000 Extremely high Likely and rapidly growing 2001 to 2003 Extremely unstable Very high Confirmed at a lower level Table 6: Internal challenge resulting from the interaction of the external challenge and stability. The internal challenge level is determined according to guidance given in the SSC-opinion on the GBR of July 2000 (as updated in 2002).
From the interaction of the two parameters stability and external challenge a conclusion is drawn on the level of internal challenge that emerged and had to be met by the system, in addition to external challenges that occurred. An external challenge resulting from cattle import could only lead to an internal challenge once imported infected cattle were rendered for feed and this contaminated feed reached domestic cattle. Cattle imported for slaughter would normally be slaughtered at an age too young to harbour plenty of BSE infectivity or to show signs, even if infected prior to import. Breeding cattle, however, would normally live much longer and only animals having problems would be slaughtered younger. If being 4-6 years old when slaughtered, they could suffer from early signs of BSE, being approaching the end of the BSE-incubation period. In that case, they would harbour, while being pre-clinical, as much infectivity as a clinical BSE case. Hence cattle imports could have led to an internal challenge about 3 years after the import of breeding cattle (that are normally imported at 20-24 months of age) that could have been infected prior to import. In case of Canada this implies that cattle imported in the mid eighties could have been rendered in the late eighties and therefore led to an internal challenge in the early 90s. On the other hand imports of contaminated MBM would lead to an internal challenge in the year of import, if fed to cattle. The feeding system is of utmost importance in this context. If it could be excluded that imported, potentially contaminated feed stuffs reached cattle, such imports might not lead to an internal challenge at all. In case of Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the Geographical BSE Risk of Canada - 14 - Canada this implies that it was possible that imported MBM reached domestic cattle and lead to an internal challenge in the early 90s. 4.2 Risk that BSE infectivity entered processing A certain risk that BSE-infected cattle entered processing in Canada, and were at least partly rendered for feed, occurred in the early 1990s when cattle imported from UK in the mid 80s could have been slaughtered. This risk continued to exist, and grew significantly in the mid 90s when domestic cattle, infected by imported MBM, reached processing. Given the low stability of the system, the risk increased over the years with continued imports of cattle and MBM from BSE risk countries. 4.3 Risk that BSE infectivity was recycled and propagated A risk that BSE-infectivity was recycled and propagated exists since a processing risk first appeared; i.e. in the early 90s. Until today this risk persists and increases fast because of the extremely unstable BSE/cattle system in Canada. 5. CONCLUSION ON THE GEOGRAPHICAL BSE-RISK 5.1 The current GBR as function of the past stability and challenge The current geographical BSE-risk (GBR) level is III, i.e. it is confirmed at a lower level that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. This assessment deviates from the previous assessment (SSC opinion, 2000) because at that time several exporting countries were not considered a potential risk. 5.2 The expected development of the GBR as a function of the past and present stability and challenge " As long as the system remains unstable, it is expected that the GBR continues to grow, even if no additional external challenges occur. " Since recent improvements in the safety of MBM production in many countries or significant recent reductions in the incidence of BSE are not taken into account for the assessment of the external challenge, the external challenge assessed after 2001 could be overestimated and is the worst case assumption. However all current GBR conclusions are not dependent on these assumptions in any of the countries assessed. For future assessments and when the impact of the production, surveillance and true incidence changes has been fully quantified, these developments should be taken into account. 5.3 Recommendations for influencing the future GBR " Enhancing the stability of the system, in particular by ensuring that cattle have no access to mammalian MBM in combination with appropriate rendering and exclusion of SRM and fallen stock from any feed chain could lead, over time, to a reduction of the GBR. " Improved passive and active surveillance, i.e. sampling of animals not showing signs compatible with BSE from at-risk cattle populations, such as adult cattle in Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the Geographical BSE Risk of Canada - 15 - fallen stock and emergency slaughter, by means of rapid screening, would allow monitoring the efficiency of stability enhancing measures. Documentation provided to EFSA " Letter with the ref D(2003)KVD/ip/420722 from the European Commission requesting a geographical risk assessment for the appearance of BSE in a country. " Country Dossier as prepared by the country in response to the EC and EFSA data collection request. " Other sources of data information i.e. exports from third countries and Eurostat data. " SSC, July 2000. Final opinion on the Geographical Risk of Bovine Spongiform Encephalopathy (GBR). " SSC, January 2002. Updated opinion on the Geographical Risk of Bovine Spongiform Encephalopathy (GBR). Acknowledgment Members of the EFSA Scientific Expert Working Group on GBR are acknowledged for their valuable contribution to this mandate. The members are: Didier Calavas, Aline De Koeijer, Michael Gravenor, John Griffin, Dagmar Heim, Matthias Kramer, Riitta Maijala, Mo Salman, Vittorio Silano, Emmanuel Vanopdenbosch, and Stig Widell. CANADA http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/563/sr02_biohaz02_canada_report_annex_en1.pdf Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL IMPORTS FROM CANADA
"Terry S. Singeltary Sr."
11/03/2003 01:19 PM To:
regulations@aphis.usda.gov cc: bcc:
Subject:
Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL IMPORTS FROM CANADA I would like to kindly comment on Docket No. 03-080-1 USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL IMPORTS FROM CANADA ; >Under this proposal, ruminant and ruminant products eligible for entry into >the United States from a BSE minimal risk region would include: > >1) bovine >animals less than 30 months of age for immediate slaughter; > >2) bovine >animals for feeding to be moved to a designated feedlot and then to >slaughter at less than 30 months of age; > snip... >6) fresh (chilled or frozen) >meat from bovines less than 30 months of age; 7) fresh (chilled or frozen) >whole or half carcasses of bovines less than 30 months of age; 8) fresh >(chilled or frozen) bovine liver; 9) fresh (chilled or frozen) bovine >tongues; 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 SNIP...FULL TEXT ; https://web01.aphis.usda.gov/BSEcom.nsf/0/b78ba677e2b0c12185256dd300649f9d?OpenDocument&AutoFramed
TSS
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