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From: TSS ()
Subject: CVM Annual Report Fiscal Year 2005 (BSe)
Date: June 2, 2006 at 1:23 pm PST

Controlling Risk From Bovine Spongiform Encephalopathy (BSE) BSE Milestones

1986 ............................
BSE is diagnosed in cattle in the UK.

1996 ............................
Variant Cruetzfeldt-Jakob Disease (vCJD) is diagnosed in humans in the UK, and is epidemiologically linked to BSE.

1997 ............................
FDA adopted BSE feed rule.

2003 ............................
First BSE-infected cow is discovered in the United States.

2004 ............................
FDA and USDA issued advanced notice of proposed rulemaking concerning regulatory measures that would strengthen the BSE feed rule.

2005 ............................
Second BSE-infected cow is discovered in the United States.

2005 ............................
FDA issued proposed amendment to BSE feed regulation to prohibit use of certain high-risk cattle materials in food or feed of all animals.


The discovery of a second BSE-infected cow in the United States, during FY 2005, added to CVM’s challenge to
strengthen controls that will prevent the spread of BSE through feed. (The first infected cow was discovered in December 2003.) BSE is a chronic, degenerative, always fatal neurological disease affecting the central nervous system of cattle.

FY 2005 Performance Goals

a Collect and analyze samples of domestic and imported feeds and feed ingredients to monitor for the presence of prohibited animal proteins (in conjunction with the Office of Regulatory Affairs [ORA]).

a Enforce the feed rule by conducting annual, targeted BSE inspections of all known renderers and feed mills processing products containing prohibited material (in conjunction with ORA).

a Allocate resources to extend BSE inspections into targeted segments of industries (e.g., animal feed salvaging, distributors, retailers, transporters, on-farm mixers, and ruminant feeds) subject to the BSE feed regulation but previously minimally inspected (in conjunction with ORA).

a Allocate resources to accomplish up to 8,760 BSE inspections; 3,760 inspections will be conducted by FDA investigators, and up to 5,000 inspections (4,100 planned State contract inspections and 900 partnership inspections) will be conducted by the States (in conjunction with ORA).

X Develop and initiate validation of an improved method for detecting prohibited animal proteins in feed using Real-Time PCR (Polymerase Chain Reaction) that will allow for the identification of up to four different prohibited species in a single reaction. Adapt the Real-Time PCR methodology to identify prohibited animal proteins in rendered materials from the European Union as well as materials rendered in the United States.

The PCR method has not been completed. We were unable to satisfactorily work out problems with the four species in one tube with a contracting firm in a timely fashion. Therefore, we are moving toward development of a real-time method with single species in a tube. Currently, we are conducting an exhaustive in-house testing of this method prior to beginning a validation study.

BSE belongs to a family of diseases known as transmissible spongiform encephalopathies (TSEs) that include several ruminant and non-ruminant animal diseases. Laboratory and epidemiological evidence strongly suggests that people can contract a human TSE, variant Cruetzfeldt-Jakob Disease (vCJD), by consuming food from BSE-infected cattle. In the absence of adequate controls, BSE could spread among the cattle population through feed ingredients derived from infected cattle.

FY 2005 Accomplishments

We continued to provide the expert scientific knowledge and review on BSE for the Agency. Much of our effort during the year focused on follow-up action related to the second BSE case, assistance to the Federal government in efforts related to the international marketing of U.S. beef, and steps toward strengthening our BSE feed regulation. We made significant progress in developing analytical methods that will enhance efficient, effective compliance with the regulation. Following are highlights of some of our achievements during the year just ended, as we focus on the FDA strategic priorities of protecting consumer and animal health, and efficient risk management.


In June 2005, the U.S. Department of Agriculture informed FDA that a cow in Texas tested positive for BSE. The animal’s carcass was disposed of by incineration, and did not enter the human food or animal feed chains. Although the animal posed no risk to the animal feed supply, FDA, along with USDA’s Animal and Plant Health Inspection Service, the Texas Animal Health Commission, and the Texas Feed and Fertilizer Control Service, conducted a feed investigation with two main objectives.

The first objective was to identify all protein sources in the animal’s feed history that could potentially have been the source of the BSE agent. The investigation found that no feed products used on the farm since 1997 had been formulated to contain prohibited mammalian protein. The second objective was to verify that cattle of interest leaving the herd after 1997 were rendered at facilities that were in compliance with FDA’s 1997 regulation that prohibits most mammalian protein in the feed for ruminants (the BSE feed rule). This part of the investigation involved visits to nine slaughter plants and eight rendering plants. The investigation found that all rendering plants were operating in compliance with the BSE feed rule. A review of the inspection history of each of these rendering firms found no previous violations.


As the fiscal year came to a close, FDA proposed new measures to help further protect consumers against the agent thought to cause BSE. The Agency proposed to amend the BSE feed regulation to prohibit from use in the food or feed of all animals certain cattle materials that have the highest risk of carrying the BSE-infectious agent. The materials include:

the brains and spinal cords from cattle 30 months of age and older;

the brains and spinal cords from cattle of any age not inspected and passed for human consumption;

the entire carcass of cattle not inspected and passed for human consumption if the brains and spinal cords have not been removed;

tallow that is derived from the materials prohibited by this proposed rule if the tallow contains more than 0.15 percent insoluble impurities; and

mechanically separated beef that is derived from the materials prohibited by the proposed rule.

All of the proposed prohibitions, except for those related to tallow, have applied to ruminant feed since the regulation’s adoption in 1997.

The removal of high-risk materials from all animal feed – including pet food – will protect against the transmission of the agent of BSE that could occur either through cross-contamination of ruminant feed with non-ruminant feed or feed ingredients during feed manufacture and transport, or through intentional or unintentional misfeeding of non-ruminant feed to ruminants on the farm. Although overall compliance with the BSE feed rule has been high, inspections have revealed some instances of cross-contamination and failure to label prohibited materials properly. Financial incentives for misfeeding exist in some circumstances. Regulatory action has been taken where problems were found, but preemptive action to avoid violations seems prudent.

We believe that the additional measures will make an already small risk even smaller. The proposed changes to the regulation build on a series of firewalls that include the BSE feed regulation, which prohibits the use of certain mammalian-origin proteins in ruminant feed (e.g., for cattle and sheep), but allows these materials to be used in feed for non-ruminant species.



Utilizing resources allocated by CVM in FY 2005 to the Office of Regulatory Affairs, FDA exceeded its goal and conducted 4,001 inspections. The States, based on available inventory of firms conducted an additional 3,309 inspections for a total of 7,310. The inspections conducted by FDA and the States included the inspection, analysis, and follow-up of all 580 firms known to process products containing prohibited material. That total also included as many inspections of related industry firms (e.g., animal feed salvagers, distributors, and retailers) as could feasibly be accomplished. We also worked with ORA in the collection, analysis and follow-up of 838 domestic and 458 imported product samples. In summary, we believe that the FY 2005 performance goals related to BSE inspections were accomplished.


CVM continued to provide BSE inspection training to FDA investigators as well as State inspectors during the fiscal year. We conducted several one-day training courses across the country, including courses in Florida, North Carolina, Idaho, and Oklahoma. CVM also had opportunities in other settings, including meetings of State feed control officials, to assist in training or to provide an update on BSE activities.


We have provided personnel and expertise on BSE and animal feed issues to the U.S. Department of Agriculture in support of its efforts to reopen foreign markets for U.S. beef. Center representatives met during FY 2005 with numerous groups from foreign governments to discuss the BSE inspection program and our feed regulations. Most of these meetings were stimulated by the decisions of a number of nations, following the discovery of the first BSE-infected cow in the U.S., to stop purchasing beef originating from the United States. These countries have been evaluating the regulation of beef and animal feed in the United States, to guide their decisions on reopening their markets to

U. S. beef. During FY 2005, we met in the United States with delegations from Korea, Taiwan, Ireland, and a number of Eastern European countries, and we accompanied U. S. delegations on trips to Canada, Japan, Korea, and China.


The availability of practical, validated methods to detect protein from different animal species could improve effectiveness and efficiency in the enforcement of the BSE feed regulation. Methods to detect mammalian protein have been available for some time, but because not all mammalian proteins are prohibited from ruminant feed, methods are needed to identify protein from prohibited species such as cattle. The development and use of such methods would be consistent with the FDA strategic plan priority of targeting limited resources for maximum protection.

Real-Time PCR Methods

During FY 2005, we continued the development of real-time polymerase chain reaction (PCR) methods for identification of appropriate species – bovine, sheep/goat, and deer/elk. (“Real-time” means that we can detect the presence of prohibited material as the reaction is taking place, so we do not have to further process the sample.) The method will detect prohibited materials prepared by either U.S. or European Union rendering processes. After discussions with analysts in FDA’s Office of Regulatory Affairs who conduct PCR analyses of animal feed, we modified our research on the real-time PCR method. We are working now to simplify the entire procedure from start to finish, thus making it very user friendly. We have identified primers4 for the appropriate species and are working on combining all components of the procedure, excluding the actual instrumentation part, into a single package. Once we have completed the in-house evaluation of this revised PCR method, we will conduct a validation study in preparation for use in the field. The Agency is currently using a traditional PCR method (not a real-time PCR) to support positive findings of animal protein by the microscopy method.

Commercial Diagnostic Kits

Commercially available diagnostic test kits marketed for the detection of ruminant proteins in animal feed can be important tools for surveillance and quality assurance. FDA does not have preclearance authority over such kits, but undertook evaluation of two of the kits in FY 2004, to assess the accuracy of claims made. We completed the evaluation of a third such kit in FY 2005. Like the two diagnostic tests previously evaluated, this test was much less sensitive than the methods the Agency uses (microscopy and PCR) for analysis of animal feed. We also identified labeling issues that need to be addressed. An evaluation of a fourth commercially available diagnostic test will be initiated in FY 2006.

4 PCR primers are short sections of DNA that mark the beginning and end of the section of the DNA template that is being copied by the PCR process. If they are specific to a known sequence of DNA nucleotides, PCR primers can identify the species from which the tested material is derived.

Avoiding Unsafe Drug Residues in Human Food Animal Drug Residue Milestones......



Deja-Moo, heard this bull before. FACTS are ;


EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA)
Last updated: 19 July 2005
Adopted July 2004 (Question N° EFSA-Q-2003-083)

Summary of the Scientific Report

The European Food Safety Authority and its Scientific Expert Working Group on the Assessment of the Geographical Bovine Spongiform Encephalopathy (BSE) Risk (GBR) were asked by the European Commission (EC) to provide an up-to-date scientific report on the GBR in the United States of America, i.e. the likelihood of the presence of one or more cattle being infected with BSE, pre-clinically as well as clinically, in USA. This scientific report addresses the GBR of USA as assessed in 2004 based on data covering the period 1980-2003.

The BSE agent was probably imported into USA and could have reached domestic cattle in the middle of the eighties. These cattle imported in the mid eighties could have been rendered in the late eighties and therefore led to an internal challenge in the early nineties. It is possible that imported meat and bone meal (MBM) into the USA reached domestic cattle and leads to an internal challenge in the early nineties.

A processing risk developed in the late 80s/early 90s when cattle imports from BSE risk countries were slaughtered or died and were processed (partly) into feed, together with some imports of MBM. This risk continued to exist, and grew significantly in the mid 90’s 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.

EFSA concludes that the current GBR level of USA is III, i.e. it is likely but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. As long as there are no significant changes in rendering or feeding, the stability remains extremely/very unstable. Thus, the probability of cattle to be (pre-clinically or clinically) infected with the BSE-agent persistently increases.

Publication date: 20 August 2004


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