Statement of Dr. Ron DeHaven Deputy Administrator for Veterinary Services Animal and Plant Health Inspection Service
United States Department of Agriculture
Before the United States Senate Committee on Appropriations Tuesday, February 24, 2004
Mr. Chairman and members of the Committee, thank you for the opportunity to appear today to discuss the Animal and Plant Health Inspection Service’s (APHIS) actions in regard to bovine spongiform encephalopathy (BSE). My name is Dr. Ron DeHaven, and I am the Deputy Administrator for APHIS’ Veterinary Services program.
Epidemiological Investigation
We announced on February 9th that we have completed the field investigation of the case of BSE in a cow in the State of Washington. I’d like to take a minute to summarize our epidemiological investigation and its findings for you.
The epidemiological tracing and DNA evidence proved that the BSE positive cow slaughtered in the State of Washington on December 9, 2003, was born on a dairy farm in Calmar, Alberta, Canada, on April 9, 1997. She was moved to the United States in September 2001 along with 80 other cattle from that dairy.
Samples were collected from the BSE positive cow on December 9 and received at the National Veterinary Services Laboratories (NVSL) on December 11. Immunohistochemistry testing for BSE, the international gold-standard and the primary test currently used by USDA for surveillance in the United States, takes approximately 10-14 days (including shipping time) from sample collection to reporting of the results. The sample collected from the cow at slaughter tested positive for BSE on December 23rd.
The epidemiological investigation to find additional animals from the source herd led to a total of 189 trace-out investigations. These investigations resulted in complete herd inventories on 51 premises in three States: Washington, Oregon and Idaho. These herd inventories involved the examination of the identification and records of more than 75,000 animals. All herd inventories have now been completed, and there are no premises remaining under hold order.
A total of 255 “Animals of Interest” were identified on 10 premises in Washington, Oregon and Idaho. “Animals of Interest” are defined as animals that were - or could have been -from the source herd in Alberta, Canada. All 255 animals were depopulated and sampled for BSE testing. Results were negative on all samples. The carcasses from all of the euthanized animals were disposed of in landfills in accordance with all Federal, State, and local regulations.
Guidelines on BSE issued by the World Organization for Animal Health (OIE), the international animal heath standard setting organization, state that animals born on a premises within one year (before or after) of a BSE-affected animal should be considered of greater risk to the country reporting the BSE detection. As such, we have focused on 25 animals also born into the birth herd of the index animal. Based on normal culling practices of local dairies, we estimated that we would be able to locate approximately 11 of these animals. APHIS definitively located 13 of these animals, plus the index cow, for a total of 14.
There are a lot of numbers being explained here. In an effort to clarify some of these points, I have attached a more specific summary to my written statement for the Subcommittee’s reference.
We are confident that the remaining animals represent very little risk. Even in countries like the United Kingdom where the prevalence of BSE has been very high, it is very uncommon to find more than one or maybe two positive animals within a herd.
In addition, the United States has had an active surveillance program for BSE for more than 13 years. A 2001 independent risk assessment by Harvard University affirmed that the United States’ control and prevention strategy is effective and that early safeguards put into place by USDA and the Department of Health and Human Services (HHS) have been largely responsible for keeping U.S. beef products safe. These controls include a longstanding ban on imports of live cattle, other ruminants and most ruminant products from high-risk countries, and the 1997 prohibition on the use of most mammalian protein in cattle feed, which Dr. Crawford will discuss shortly. The risk assessment was updated in 2003 following the finding of a case of BSE in Canada last May. The update further affirms that even with a detection of BSE in this country, U.S. control efforts would minimize any possible spread of the disease and ultimately eliminate it from the U.S. cattle population.
On December 30, Secretary Veneman announced additional protection measures to guard against BSE. In addition to directing the accelerated implementation of an animal identification system, the Secretary also announced new measures regarding animals going to slaughter. Dr. Murano will discuss those in more detail in her testimony.
Surveillance and Testing
I’d like to take a minute to explain our surveillance and testing program. USDA has had safeguards in place since July of 1989, when we prohibited the importation of ruminants from countries affected with BSE. In December 1997, the prohibition was expanded to include the entirety of Europe due to risk factors associated with BSE. The United States has had an active surveillance program for BSE in place since May 1990. Our surveillance strategy is the result of a national approach to BSE surveillance that represents the distribution of the adult cattle population in the United States. The strategy has always focused testing efforts on those animals which fall into the highest-risk category for the disease.
Specifically, the surveillance samples include field cases of cattle exhibiting signs of neurologic disease, cattle condemned at slaughter for neurologic reasons, rabies-negative cattle submitted to public health laboratories and veterinary teaching hospitals, and sampling of cattle that are nonambulatory, also known as “downer cattle.” Because the population of nonambulatory disabled animals will no longer be coming to slaughter plants and will no longer be going into the human food chain, we are working with industry representatives to reposition our efforts to collect those samples on the farm, at rendering facilities, and at plants where meat products are harvested for animal food and other nonedible purposes.
In 2003, USDA tested 20,543 cattle for BSE, of which 16,560 were nonambulatory. In 2002, we tested 19,990, of which 14,951 were nonambulatory. The remainder were animals condemned because of central nervous system symptoms and dead stock. Under this surveillance model, we would be able to detect, if present, 1 BSE-infected animal per 1 million head of all cattle with a 95 percent confidence rate. This sampling rate is 47 times the recommended international standard for BSE surveillance for a country at low-risk for the disease. We plan to double our sampling efforts in 2004 and test approximately 40,000 head of cattle. The President’s Fiscal Year 2005 Budget includes $17 million for the APHIS to collect and test 40,000 samples for BSE. Further refinements to our surveillance efforts are currently being considered.
USDA is committed—and the industry shares this commitment—to ensuring that a robust surveillance program for BSE continues in this country. USDA will be working very closely with the rendering and animal disposal industry and other government agencies to ensure that USDA continues to have access to the population of animals considered to be at highest risk for BSE.
In addition to the monies for increased surveillance, the President’s FY 2005 budget also includes $178 million for the Agricultural Research Service to complete the renovation of USDA’s National Centers for Animal Health in Ames, Iowa. The Centers include the National Veterinary Services Laboratories (NVSL), our diagnostic testing facility for BSE. The President’s request would represent the final installment of the $460 million needed to fully renovate the facilities and, if approved by Congress, will permit USDA to complete the project by the end of 2007. When the renovation is completed, the Centers will include almost 1 million square feet of thoroughly modern facilities that will be biosafe, energy-efficient and will provide state-of-the-art capabilities for research and diagnosis.
NVSL is not only the principal laboratory for the diagnosis of BSE, it also diagnoses many other animal diseases of vital concern, including highly pathogenic avian influenza, exotic Newcastle disease (END), bovine tuberculosis, and brucellosis. Scientists at NVSL play a central role in our surveillance for foreign animal diseases and are working on our most pressing agricultural health issues. They are recognized throughout the country and around the world for their expertise.
We are also in the process of approving so-called “rapid tests” for BSE. We announced in January that we would begin formally accepting license applications for BSE rapid test kits. These tests are less specific than the immunohistochemistry (IHC) test that USDA has designated as the official test for BSE, but can produce results for screening purposes more quickly. Internationally, IHC is considered the 'gold standard' diagnostic test method. We are now reviewing and responding to the data submissions, physically inspecting the facilities where these test kits would be produced, and testing the kits at NVSL. We are continuing to evaluate what role approved test kits should play in our enhanced national surveillance efforts.
International Review Subcommittee Report
On December 30, 2003, the Secretary announced that an international panel of experts would be convened to review our BSE investigative efforts. Because of the role that Secretary’s Advisory Committee on Foreign Animal and Poultry Diseases plays in advising the Secretary on measures to prevent the introduction of foreign animal disease, the Advisory Committee and USDA determined that this panel should be a subcommittee of the Advisory Committee. The subcommittee was asked to make recommendations for possible further enhancements to our systems, including recommendations on changes to our current surveillance systems, in light of the current situation.
The subcommittee is composed of four of the same experts who reviewed the Canadian situation. The team consisted of Prof. Ulrich Kihm, President and CEO, Safe Foods Solutions, Switzerland; Prof. William Hueston, Director, Center for Animal Health and Food Safety, University of Minnesota, U.S.A.; Prof. Stuart C. MacDiarmid, Principal Advisor, Zoonoses and Animal Health, New Zealand Food and Safety Authority, New Zealand; and Dr. Dagmar Heim, TSE Coordinator, Federal Veterinary Office of Switzerland, Switzerland. Dr. Danny Matthews, TSE Programme Manager, Veterinary Laboratories Agency, United Kingdom, was not on the Canadian review team, but was added to the U.S. review team.
The subcommittee met in Washington from January 22 24 and considered the data provided on the Washington State BSE investigation. The subcommittee also evaluated actions undertaken, as well as actions being considered, in response to the BSE situation. They delivered their report to the Advisory Committee on February 4th. That same afternoon, the Co-chairs of the Advisory Committee and members of the subcommittee provided the Secretary a copy of the report and briefed her on its content. The report indicated that actions announced on December 30 and subsequent FDA announcement have further enhanced the protection of human and animal health.
Included in the report was an evaluation of the epidemiological investigation; the tracing of products derived from the index case and cattle slaughtered on the same day and on the same premises as the index case; the tracing of by products arising from the processing of offal and waste derived from the index case; and termination of the epidemiological investigation. In addition, the group evaluated the actions taken in response to the BSE find including those taken in regard to specified risk materials, nonambulatory (downer) cows, surveillance, laboratory diagnosis, feed restrictions, traceability, and education. We have attached a copy of the report to my written statement for the Subcommittee’s review.
The Advisory Committee discussed the subcommittee report and has provided additional recommendations to the Secretary. These recommendations include asking representatives of Harvard University to review the subcommittee report and its findings in the context of Harvard’s risk model and report the results of the review back to the Secretary and the Advisory Committee. The Committee also recommended, among other things, the immediate development of an enhanced national surveillance program for BSE to increase testing of high risk animals; the implementation of a comprehensive system to facilitate adequate pathways for dead and non-ambulatory cattle; the enhanced development of the National Animal Health Laboratory Network; and the enhanced development and dissemination of BSE information to the media, public and all industry stakeholders. The Committee recommended that the Secretary encourage major beef exporting nations to work through the OIE to rationalize trading protocols. The Secretary will be considering all this information as she considers future actions in regard to BSE.
Live Cattle from Canada
We are continuing to evaluate our regulations regarding BSE in regard to our trading partners. In November, we published a proposed rule that would establish criteria for determining minimal risk regions of the world for BSE. The rule also proposed including Canada on the list of minimal risk regions and establishing conditions for the importation of certain live ruminants, ruminant products, and ruminant byproducts from regions designated as minimal risk for BSE. The proposed rule’s comment period closed on January 5, 2004. USDA received more than 600 comments. At some point soon, we plan to reopen the comment period to give the public a chance to extend their comments to consider the investigation.
The Administration’s actions since December 23, 2003, to manage the potential threat posed by BSE in the United States are a reflection of our aggressive action over the past several months and years. Even with the conclusion of our investigation, we continue to evaluate the situation and monitor the emerging body of science in order to determine future actions. Thank you very much for the opportunity to speak with you today and I will be pleased to answer any questions you may have.
Attachment I
BSE Investigation Breakdown Summaries
Summary of the 255 depopulated: •28 were part of the 81 •220 could have been part of the 81 •7 heifers that were part of group of 17 heifers, some, but not all of which, entered the United States
Of the 81 that came in from Canada (29 definitively accounted for): •1 is the BSE-positive cow and was located in the Index herd in Mabton, WA. •9 were located in the Index herd in Mabton, WA. •3 were located at a facility in Tenino, WA. •6 were located at a facility in Connell, WA. •1 was located at a facility in Quincy, WA. •3 were located at a facility in Mattawa, WA. •1 was located at a facility in Moxee, WA. •3 were located at a facility in Burley, ID. •1 was located at a facility in Othello, WA. •1 was located a facility in Mabton, WA.
Of the 17 other cattle from the Canadian birth herd (these heifers are not part of the original 81 animals and it is not known how many of the 17 actually entered the United States). To date, seven animals have been identified in the United States:
•3 were at a facility in Quincy, WA. •1 was at a facility in Boardman, OR. •1 was at a facility in Othello, WA. •1 was at a facility in Burley, ID •1 was at the second facility in Mabton, WA
Depopulation Activities
USDA has conducted selective depopulation activities at these facilities:
•Sunnyside, WA (bull calf premises) - a total of 449 animals depopulated •Mabton, WA (index premises) - a total of 131 animals depopulated •Mattawa, WA - a total of 39 animals depopulated •Connell, WA - a total of 15 animals depopulated •Boardman, OR - a total of 20 animals depopulated •Quincy, WA – a total of 18 animals depopulated •Tenino, WA – a total of 4 animals depopulated •Moxee, WA – a total of 15 animals depopulated •Othello, WA – a total of 3 animals depopulated •Burley, ID – a total of 7 animals depopulated •Mabton, WA (second premises) – a total of 3 animals depopulated
Testing Activities
All adult animals depopulated were sampled and tested for BSE. The bull calves depopulated at Sunnyside, WA, were not sampled because they were too young for the BSE agent to be detected. There have been a total of 255 samples taken from the animals depopulated in the Mabton index herd, the herds in Mattawa, Connell, Quincy, Tenino, Moxee, Othello, and the second Mabton facility, as well as facilities in Boardman, OR, and Burley, ID. All samples have tested negative for BSE.
Attachment II
Report of the Secretary’s Advisory Committee on Foreign Animal and Poultry Diseases
Measures Relating to Bovine Spongiform Encephalopathy in the United States
February 13, 2004
Introduction
The Secretary’s Advisory Committee on Foreign Animal and Poultry Diseases (hereafter referred to as the Committee) wishes to thank the members of the International Review Subcommittee (hereafter referred to as the Subcommittee) for their Report on Measures Relating to Bovine Spongiform Encephalopathy in the United States (hereafter referred to as the Report).
The Committee wishes to recognize the outstanding effort put forth by Secretary Ann Veneman and her staff at USDA following the discovery of bovine spongiform encephalopathy (BSE) in a cow in the state of Washington. Her leadership and transparent communication with the public, media and stakeholders were directly responsible for maintaining public confidence in the actions taken and in the safety of the food supply. This direct communication was extremely beneficial to prevent unnecessary interstate movement restrictions. She continually emphasized that actions, policies and regulations were based on the best available science to protect both public health and animal health.
Specific recognition is given to Dr. Ron DeHaven, Chief Veterinary Officer for the US for his tireless commitment to the investigation and his excellent communication skills in providing regular updates on the situation. In addition, the Committee wishes to recognize and thank all of the management and field staff at USDA, the State of Washington, and all other state and federal agencies that worked around the clock to complete this investigation.
Recognition of Positive Findings by the Subcommittee
The Committee wishes to recognize the many positive findings stated in the briefing by the Subcommittee representatives and further documented in the Report, including:
• The openness, full disclosure and access to personnel provided by USDA;
• Commending the Secretary on the open manner in which the investigation was conducted and for making their findings immediately available to the public;
• The epidemiological investigation as to the origin of the index case conformed to international standards, even though the trace was hindered due to the lack of a national animal identification system;
• The ability of USDA personnel to work cooperatively with their Canadian counterparts when it became obvious there was an epidemiological connection; this demonstrated a long-standing, close working relationship between countries;
• Tracing and recall of the rendered meat and bone meal possibly made from the positive cow was effective and appropriate;
• The U.S. ban on specified risk materials from cattle over 30 months of age removes the highest risk tissues from the human food supply and is in accordance with international standard;
• Prohibition of air injection stunning of cattle was appropriate to prevent cross-contamination of the carcass;
• Recognizing the merits of the ban prohibiting non-ambulatory cattle from entering the food supply, but also noted the unintended consequences of making it more difficult for surveillance of this high risk group;
• Agreement by the Subcommittee that testing of all cattle slaughtered for human consumption is unjustified in terms of protecting human and animal health.
Concerns Regarding Differing Opinions on Risk
The Subcommittee made many additional recommendations. However, the Committee cannot adequately resolve the differing BSE risk assessment presented by the Subcommittee as compared to the assessment by Harvard University. A major discrepancy exists with the Subcommittee’s conclusions that BSE continues to circulate, or even amplify, in the US and North America, when compared with the Harvard risk assessment. The Committee must have this issue of risk resolved prior to completing its recommendations to the Secretary. It is imperative that the Secretary has the best available science and more precise risk assessments in order to make appropriate regulatory decisions.
Recommendations by the Committee
• Prior to implementing regulatory changes in addition to what USDA and FDA have already announced, the Committee recommends that representatives of Harvard University be asked to review the Subcommittee Report and its findings (Harvard and the Subcommittee should communicate directly and come to consensus if possible) in light of the risk model they have previously developed and report back to the Secretary and this Committee;
• Immediately develop and implement an enhanced national surveillance program for BSE to increase testing of high risk animals (cattle showing symptoms of central nervous system disease, non-ambulatory cattle, and cattle that die on farms); this action will further the scientific evaluation of risk for BSE in the U.S. and North America;
• Concurrent with an enhanced surveillance for BSE, a comprehensive system must be implemented to facilitate adequate pathways for dead and non-ambulatory cattle to allow for collection of samples, and for proper, safe disposal of carcasses; this must be done to ensure protection of public health, animal health and the environment; such as system will require expending federal resources to assist with costs for sampling, transport and safe disposal;
• Supports the Secretary’s announcement to move quickly to implement a verifiable national animal identification and tracking system as envisioned by the United States Animal Identification Plan (USAIP) that has been endorsed by the United States Animal Health Association; however, provisions must be taken to allow for incorporation of new technologies as they become available;
• Enhance development of the National Laboratory Network, specifically to approve additional regional laboratories to conduct rapid screening tests for BSE, but maintain confirmatory testing with the National Veterinary Services Laboratory; there will be a need to provide more rapid results to packers, renderers and others for testing and release of carcasses in the food, rendering and disposal systems;
• Enhance development and dissemination of BSE information to the media, public and all industry stakeholders to ensure that everyone understands the mechanisms of BSE transmission (not contagious) and safeguards necessary for its control;
• Encourages major beef exporting nations to work through the OIE to rationalize trading protocols that apply to countries with a low number of BSE cases which have adequate safeguards in place.
Conclusion
The Committee again wants to commend the Secretary and all of her staff at USDA and officials in the State of Washington and FDA for their efforts and swift action to address the first case of BSE in the U.S. It is imperative that all future decisions be based on the best available science and that all necessary steps be taken to protect the safety of the public as well as the economic viability of animal agriculture in the United States.
