Testimony of
Larry A. Schuler DVM
State Veterinarian
North Dakota Department of Agriculture
State Board of Animal Health
On

BSE and Related Issues

Hearing held by
US Senator Kent Conrad
Pioneer Room of the North Dakota State Capital
Bismarck, North Dakota
January 9, 2004
10:00 AM

Good Morning Senator Conrad. I am Larry Schuler, the state veterinarian in North Dakota I am very pleased to be with you today to discuss the recent case of Bovine Spongiform Encephalopathy (BSE) in the United States and issues related to prevention of new cases and further protection of the animal and public health of this country.

Safety of US Beef

We would like to begin our comments by saying that we believe that the US beef supply is safe. There is very little risk to the beef consuming public. The firewalls that the United States has erected in the past are very effective and the 2001 Harvard University Center for Risk Assessment report says:

Only a small amount of potentially dangerous tissues would reach the human food supply and be available for possible human consumption. We express the amount of infectivity in terms of cattle oral ID50s for the purpose of quantifying both animal and human exposure to this agent. A cattle oral ID50 is the amount of infectious tissue that would, on average, cause 50% of exposed cattle to develop BSE. The relationship between human exposure quantified in terms of cattle oral ID50s and likelihood of human disease is unknown, but European authorities suggest that the cattle disease may be 10 to 100,000 times less virulent in humans (SSC, 1999, SSC, 2000a). In the entire 20 year period following the import of ten BSE-infected cattle, the mean estimate for the amount of infectivity potentially available for human exposure is 35 cattle oral ID50s. The greatest sources of infectivity include consumption of cattle brain, spinal cord, and meat derived from advanced meat recovery systems. Some potential exposure would result from the presence of spinal cord in certain bone-in cuts of beef, like T-bone steaks, and consumption of cattle intestines. Potential human exposure resulting from spontaneous disease or cross-species transmission of scrapie are predicted to be less than 100 cattle oral ID50s over 20 years.

Even in an extreme case, which we characterize using the 95th percentile of the output distribution from the simulation, the import of ten animals leads to only 11 new cases of BSE over twenty years. The 95th percentile value for potential human exposure is 170 cattle oral ID50s over 20 years, approximately five times the mean value. These predictions can be compared with the experience in the United Kingdom, where it is estimated that there were nearly one million infected animals and it is likely millions of cattle oral ID50s available for potential human exposure.

In layman's terms, the 2001 Harvard University Center for Risk Assessment report says that if BSE was imported into the United States, the existing control measures would eliminate the disease within 20 years and that during this time human exposure would be extremely small.

We can use the United Kingdom as an example of how BSE behaves as a zoonotic disease in a population. Historically, BSE has had the greatest impact on the animal and livestock populations of that country. At the peak of the BSE epidemic, the UK was reporting approximately 1000 cases of BSE in cattle per week. At the beginning of the outbreak there were no control measures to prevent the introduction of the BSE agent into the human food supply. However, to date, there have been only 139 cases of variant Creutzfeld Jakob Disease (vCJD) reported in that country. The human exposure in the United States would be exponentially smaller than it was in the UK with the controls measures that are currently in place.

Reaction to USDA Response

We support the steps that USDA has taken to date to respond to the case of BSE in the United States. A diagnosis was made quickly and a rapid response is being mounted. USDA, with the cooperation of the State of Washington, has done what is necessary to control the disease and to prevent the movement of animals out of affected herds.

We support the additional safeguards announced on December 30, 2003 by Agriculture Secretary Ann M. Veneman to bolster the U.S. protection systems against BSE and further protect public health. Specifically, USDA announced the following actions:

Downer Animals. Effectively immediately, USDA will ban all downer cattle from the human food chain. USDA will continue its BSE surveillance program.

Product Holding. USDA Food Safety and Inspection Service inspectors will no longer mark cattle tested for BSE as "inspected and passed" until confirmation is received that the animals have, in fact, tested negative for BSE. This new policy will be in the form of an interpretive rule that will be published in the Federal Register.

Specified Risk Material. Effective immediately upon publication in the Federal Register, USDA will enhance its regulations by declaring as specified risk materials skull, brain, trigeminal ganglia, eyes, vertebral column, spinal cord and dorsal root ganglia of cattle over 30 months of age and the small intestine of cattle of all ages, thus prohibiting their use in the human food supply. Tonsils from all cattle are already considered inedible and therefore do not enter the food supply. These enhancements are consistent with the actions taken by Canada after the discovery of BSE in May.

In an interim final rule, FSIS will require federally inspected establishments that slaughter cattle to develop, implement, and maintain procedures to remove, segregate, and dispose of these specified risk materials so that they cannot enter the food chain. Plants must also make that information readily available for review by FSIS inspection personnel. FSIS has also developed procedures for verifying the approximate age of cattle that are slaughtered in official establishments. State inspected plants must have equivalent procedures in place.

Advanced Meat Recovery. AMR is an industrial technology that removes muscle tissue from the bone of beef carcasses under high pressure without incorporating bone material. AMR product can be labeled as "meat." FSIS has previously had regulations in place that prohibit spinal cord from being included in products labeled as "meat." The regulation, effective upon publication in the Federal Register, expands that prohibition to include dorsal root ganglia, clusters of nerve cells connected to the spinal cord along the vertebrae column, in addition to spinal cord tissue. Like spinal cord, the dorsal root ganglia may also contain BSE infectivity if the animal is infected. In addition, because the vertebral column and skull in cattle 30 months and older will be considered inedible, it cannot be used for AMR.

Air-Injection Stunning. To ensure that portions of the brain are not dislocated into the tissues of the carcass as a consequence of humanely stunning cattle during the slaughter process, FSIS is issuing a regulation to ban the practice of air-injection stunning.

Mechanically Separated Meat. USDA will prohibit use of mechanically separated meat in human food.

We are concerned that perhaps some of these steps do not go far enough, and we will address those issues later.

We (i.e. state officials) feel that we have been "left out of the loop" with regards to information regarding the BSE case and the subsequent investigation. Our first knowledge of the BSE case in Washington was when we heard it on CNN. We have subsequently received virtually all of our information from the Technical Briefings that USDA provides for the news media. This leaves state officials at a disadvantage when it comes to dealing with local concerns and questions. USDA has for a long time spoken to state officials as partners. Many times in this situation, however, we have felt more like spectators than partners.

Priority Issues

Consumer Safety

First and foremost, consumer safety is the primary priority issue that needs to be addressed. As I said earlier, we believe that the US beef supply is safe and that exposure to the beef consuming public is almost zero. However, USDA and its partners need to review the entire beef production system and take the steps necessary to close loopholes that could possibly result in human or animal exposure.

Reestablish Export Markets

Secondly, reestablishment of international trade of US beef should also be a high priority for USDA. Export sale of beef makes up 9 percent of the beef industry sales. The loss of these markets has resulted in a substantial drop in livestock values. The industry can withstand short term market droops, but long terms price drops will be devastating to the industry. This loss will make the difference in the survival of many cattle producers, who prior to this BSE case were anticipating and needed record prices for their animals.

We believe that USDA should respond to the BSE case in Washington in much the same way that Canada responded to their BSE case in a British imported animal in 1993. Basically, the herd in which the infected animal was found should be depopulated and tested for BSE. All animals that are traced out of this herd and all animals that are in the group of 81 other animals that were imported with the infected animal should also be depopulated and tested. Congress should provide the funding necessary to provide for the depopulation, testing and indemnity of the owners. We estimate this may cost $7-10 million, which is a small price to pay for a lost export market in excess of $2.8 billion.

Additionally, we believe that a traceback of Canadian animals imported into the United States should be done. There are an estimated 300,000-400,000 breeding animals in the US that were imported from Canada. This appears to be an insurmountable task. However, we propose that the traceback should be focused on potential cohorts of the two affected Canadian animals that have been identified in the last year. The traceback should focus on cattle over 5 years of age from the provinces of Saskatchewan or Alberta. This would dramatically reduce the number of animals that would need to be found and tested. We are currently reviewing health certificates in the state veterinarian's office to determine the number of animals that meet these criteria in North Dakota. Nevertheless, it will be a major task and would take additional resources.

We also believe that the US should set importation standards that are at least equal to international standards for importation of animals. The recently proposed rule regarding BSE Minimal Risk Regions concerns us because the rule would establish a standard for importation that is less stringent than international standards. Office of International Epizootics (OIE) has standards for regions to qualify as minimal risk regions in countries where BSE was identified less than 7 years ago. However, a reading of the OIE Standards reveals that, when applied to the present case, Canada fails to meet those standards.

This is where the proposed rule was more lenient than OIE standards. The OIE standard requires that, in countries where BSE was identified less than 7 years ago, there be a feed ban in place for 8 years. Canada's feed ban went into effect in 1997. Therefore, the Canadian feed ban went into effect approximately 6 ½ years ago.

The OIE standard for a Minimal Risk BSE country or zone is quoted below:

b) the last indigenous case of BSE has been reported less than 7 years ago, and the BSE incidence rate, calculated on the basis of indigenous cases, has been less than one case per million during each of the last four consecutive 12-month periods within the cattle population over 24 months of age in the country or zone (Note: For countries with a population of less than one million adult cattle, the maximum allowed incidence should be expressed in cattle-years.), and:

i) the ban on feeding ruminants with meat-and-bone meal and greaves derived from ruminants has been effectively enforced for at least 8 years;

The possibility of reestablishing our beef export markets is very slim when our importation standards are lower than international standards. We have seen the responses of our major trading partners to the single Canadian BSE case and the single US case that was imported from Canada. We are concerned that their animal health officials will maintain the ban unless we remain at least equal to international standards.

We are also concerned about the request made by the US to OIE to lower the international standard for an effective feed ban to 5 years. This creates a great deal of concern because of the possibility that residual ruminant protein feed was fed in some countries for several years after the feed ban went into effect. Asking the OIE to lower their standards for trade purposes should not be our intent. The goal of international standards should be to prevent prion transmission among regions while allowing trade with as little risk as possible.

Another issue with regards to the reestablishment of trade is the ruminant feed ban and potential loopholes in it. The European Union has a Scientific Steering Committee that conducts an assessment of Geographic BSE Risk (GBR). Nations or regions are classified according to the risk level that exists based on risk factors for having BSE. Currently, both the US and Canada are classified as GBR Level II (i.e. unlikely to have BSE, but can not exclude from the potential to have BSE). Based on the formula that the Scientific Steering Committee has set up, Canada will go to a GBR Level III (i.e. likely to have BSE, but not confirmed, or present at a lower level). Based on the number of Canadian imports of live cattle and feed, the US will also go to a GBR Level III. The key to regaining our Level II status will be to establish regulations that break the transmission cycle. The primary means of transmission is through the feeding of ruminant products back to ruminants. Therefore, eliminating ruminant protein from ruminant feed becomes central to lowering our risk status. There are several actions that should be taken with regards to the ruminant feed ban.

1. As a result of Secretary Veneman's announcement of steps to bolster the US protection system, Specified Risk Materials (SRM) are now required to be removed from cattle over 30 months of age that are slaughtered. Currently, SRM will be allowed to be rendered. We believe these materials should not be allowed to be rendered. Very few rendering plants have dedicated lines for rendering of ruminant products so the potential for cross contamination exists.
2. Poultry litter should not be allowed to be fed to ruminants. Ruminant protein can legally be fed to poultry, and there is a certain amount of spilled feed contained in poultry litter. This leads to exposure of cattle to ruminant protein through the litter as it is fed.
3. Standards for maximum protein levels in tallow should be set. Beef tallow contains a small amount of protein, and the United States does not have specifications as to maximum allowable levels of protein in tallow intended for cattle feed.
4. FDA must expand feed ban compliance inspections. This should be accomplished with the assistance and cooperation of the state animal health official.
5. Border inspections need to be strengthened to prevent the importation of feeds or feed ingredients not complying with the feed ban rule.
6. Other current exclusions from the feed ban also deserve further scientific review. There is considerable debate concerning blood products and plate waste in ruminant feed.

BSE Surveillance

Surveillance for BSE in the United States will have to increase to meet the requirements of our trading partners. We need to consider adopting even more stringent standards with regards to those countries which impose higher, more restrictive surveillance standards on their own domestic industries.

The removal of "downer" animals from slaughter channels has eliminated a source of samples for BSE surveillance. Other creative strategies need to be developed to obtain an adequate and statistically significant number of samples from high risk animals.

Currently, the United States is using immunohistochemistry (IHC) as the standard test for BSE in this country. IHC is costly and time consuming. We urge the use of quicker tests for surveillance purposes. Positive quick tests could then be confirmed with IHC. The approximate cost of doing quick tests (Biorad®, for example) is $15 per test. We would request funding from Congress to support the level of testing that is necessary to satisfy our trading partners and the US consumer.

United States Animal Identification Plan (USAIP)

The USAIP will provide the United States with a system capable of tracing an animal, or group of animals, back to the herd that is the most logical source of a disease of concern as well as tracing potentially exposed animals that were moved out from the subject premises. The long-term goal is to provide information within 48-hours on all animals that came in contact with the subject animal at each premises. Such capability is dependent on how comprehensive the system infrastructure developed to collect and record the movements of animals is.

The USAIP is needed to maintain the economic viability of American animal agriculture. This national plan will enhance disease preparedness by rapidly identifying animals exposed to disease permitting rapid detection, containment, and elimination of disease threats. This is essential to preserving the domestic and international marketability of our nation's animals and animal products. The USAIP will uphold the nation's reputation for having a safe food supply and will promote continued confidence in livestock products.

The USAIP has evolved since 2002 when industry leaders developed the National Food Animal Identification Plan. The USAIP resulted from further advancement of the Work Plan through the efforts of the 2003 National Animal Identification Development Team (NIDT). Established by USDA/APHIS/VS at the request of the United States Animal Health Association, the team is composed of approximately 100 animal and livestock industry professionals representing over 70 associations, organizations, and government agencies.

The USAIP defines the standards and framework for implementing and maintaining a national animal identification system for the United States, and includes a premises numbering system, an individual and group/lot animal number system and standards for radio frequency technology used for animal identification.

Confidentiality of the data remains the producer's greatest concern under this system, and USDA and state officials are exploring appropriate solutions.

Animals entering the United States from other countries should be subject to the same identification procedures as animals already in this country. The Canadian identification program is compatible with the USAIP. The identification devices that are on animals entering the United States should remain on the animals as official devices and not be removed.

The primary source for current information is located at www.usaip.info. This is an interactive website that provides details on the development of the plan as well as specific information directed at the segments of the livestock industry involved in the identification effort.

While preliminary projections for financial requirements have been made, it must be recognized that the plan is still being developed. Initial start-up costs will be different than the costs of a fully operational system in all 50 states and will be directly related to the extent in which animal movements are recorded.

The 2003 draft USAIP was presented at the United States Animal Health Association (USAHA) meeting in October 2003. A resolution (attached) at USAHA accepted the plan as a work in progress and encouraged its further refinement and implementation.

The USAIP Draft Document (attached) contains a projected budget (pages 47-48) for the USAIP. Initial first year start up costs are estimated to be $20 million. The following years have higher costs because more identification devices are applied to animals during those years. We urge Congress to fully fund the USAIP during the startup years and to continue to fund the Identification Program at a maintenance level following that.

Livestock producers are certainly willing to bear a portion of the cost. They believe that the bulk of the cost should be the responsibility of the USDA since these identification devices will replace other ID that is currently being provided by USDA and the nature of the devices will streamline many of USDA's animal health programs and recordkeeping systems.

Maintenance of Identification

Living in a border state has made it is clear to us that animals "leak" out of the trade channels for which they were imported. It is not uncommon to find slaughter animals outside of slaughter channels and feeder animals outside of feeder channels. As a matter of fact, it is not uncommon for identification tags to be removed from feeder cattle prior to resale to improve the market value of the animals. There are currently no restrictions on the removal of identification tags from animals after they are imported into the US.

We believe that it is imperative that regulations be developed that prohibit the removal of official identification from animals. USDA must enact interim emergency regulations prohibiting removal of any official ID from cattle imported from a foreign country. A meaningful penalty must be associated with removal of identification in order to achieve compliance.

Country of Origin Labeling (COOL)

Country of Origin Labeling should be considered with regards to protecting consumer confidence in the US. COOL would provide consumers with at least the opportunity to select meat from countries which they perceive as safe. We strongly recommend that COOL be fully implemented in the US so consumers would have more specific knowledge as to the origin of their beef. In the event of another BSE case, consumers would then be able to differentiate product in the marketplace and may feel more confident in their beef purchases. This would arguably lead to a smaller decrease in expected demand for beef, which should serve to decrease the negative price impacts which would certainly follow the discovery of another BSE case.

Laboratory Capacity

With increased surveillance there will also be a need for more laboratory capacity to meet the needs of a BSE surveillance system. We urge Congress to provide adequate funding to build the laboratory infrastructure that is necessary to meet the demands of increased surveillance.

Along those lines, we urge completion of the USDA APHIS-ARS Master Plan for a new facility in Ames, Iowa, to meet BSE surveillance activity needs as well as urgent national needs for research, diagnosis, and product testing related to animal health. The proposed facility will replace outdated and inefficient facilities currently used by the APHIS National Veterinary Services Laboratories (NVSL), the APHIS Center for Veterinary Biologics (CVB), and the ARS National Animal Disease Center (NADC).

The new facility will address new national and international standards for biocontainment, animal handling, personnel safety and health, quality assurance, and environmental protection. It will consolidate facilities currently dispersed in Ames, thereby increasing efficiency and collaboration, and increase high security laboratory and animal capacity. The new facility will help safeguard the $100 billion livestock, poultry, and companion animal industries, as well as protect against human health threats such as foodborne illness and zoonotic disease.

BSE Prevention through Importation of Live Animals- Reactive vs. Proactive

There is a major disparity in USDA's approach to the prevention of the introduction of a disease into the US between BSE and other foreign animal diseases. With most foreign animal diseases, USDA is proactive (i.e. We do not allow the importation of animals from a country until adequate surveillance has been done to prove that the disease is not present within that country.). In the case of BSE, USDA is reactive (i.e. the US will trade with a country until a case of BSE is identified.). This is very disconcerting when you consider the long incubation period of BSE and that BSE is a public health issue as well as an animal health issue.

We believe that this places the US at risk of importing BSE since USDA is reacting after the fact to BSE cases reported in the various countries that trade with the US. We urge USDA to clearly define proactive standards for trade with regards to BSE.

Advanced Meat Recovery (AMR)

Advance Meat Recovery (AMR) systems are notorious for containing nervous tissue derived from the dorsal root ganglia (a specified risk material) in the final product. In the worst case scenario of the Harvard Risk Assessment, approximately one-half of the infectious doses (ID 50) to which humans would be exposed would be derived from AMR products.

We strongly urge the prohibition of AMR systems when slaughtering animals or, at least, extensive testing should be required for determining the presence of nerve tissue in the AMR meats.

MASDA and NASDA Resolution

In July 2003, the Midwestern Association of State Departments of Agriculture (MASDA) approved a resolution concerning BSE. We helped draft and fully support that resolution, which is attached.

The MASDA resolution was forwarded to the National Association of State Departments of Agriculture (NASDA) and was adopted with minor changes (attached).

Conclusion

Senator Conrad, thank you for the opportunity to provide this information.

We urge aggressive activity by USDA to reestablish our beef export markets.

We urge the Food and Drug Administration (FDA) to reevaluate the ruminant feed ban and ask them to set science based standards for protein levels in tallow.

As I alluded to earlier, the 2001 Harvard University Center for Risk Assessment report concluded that "measures taken by the U.S. government and industry make the U.S. robust against the spread of BSE to animals or humans should it be introduced in this country." However, with the finding of a case in the US, a reevaluation of the BSE prevention strategies is in order and steps should be taken to further assure that all responsible measures have been taken to assure the protection of the animal and public health of this country. Thank you.