Questions and Answers on BSE
(Items 14-22 added on May 18, 2005)
[Overall BSE measures/firewalls]
- Are all cattle inspected prior to slaughter?
- Why isn't USDA testing all cattle slaughtered in the United States?
- Do you think you will find more cases of BSE? (APHIS)
- Are all SRMs properly removed? What is the procedure? How is SRM-removal and prevention of cross-contamination ensured?
- Isn't Advanced Meat Recovery (AMR) still being used?
- Feed ban: The United States claims that it has been implementing a ban on feeding mammalian proteins to ruminants since 1997, but it still is primarily a ruminant-to-ruminant feed ban. How can you prevent bovine-derived poultry feed, for example, from commingling with cattle feed?
- What is A Maturity?
- How can A40 assure that animals are younger than 21 months old?
- How can you verify that each inspector correctly and consistently performs the maturity grading? Do you have any monitoring system in place to assure the accuracy of the inspector?
- What is vCJD? How many vCJD cases have been found in the United States? What about the alleged cases in New Jersey?
- With respect to trade between the United States and Canada, now that Canada has found 3 BSE cases (4 including the one found in Washington state), how will the United States ensure that no BSE-infected animals will enter the United States when the U.S.-Canadian border opens?
- A recent Government Accountability Office (GAO) report found that 19 percent of the feed industry has not been re-inspected in the past five years. How can the FDA ensure the Japanese people that U.S. cattle are not consuming meat-and-bone meal?
- Union Chairman's Allegation on inadequate SRM removal.
- Are the media reports about a USDA cover-up of a BSE-positive case true?
- I understand that U.S. beef was included in a shipment of pork to Japan last fall. How did such a mistake happen?
- Why is the U.S. forcing a "vague" A40 method for determining age on the Japanese consumer?
- Why hasn't the U.S. bothered to implement an animal ID system?
- How can the U.S. deny the two cases of BSE in young animals in Japan when the Japanese scientists confirmed them as BSE?
- Why doesn't the U.S. agree to do 100% testing?
- What is the U.S. response to the EU's classification of the U.S. as having a risk level III in its geographical bovine encephalopathy risk assessment (GBR)?
A1. All cattle slaughtered in federally inspected establishments in the United States are subject to inspection by USDA's Food Safety Inspection Service (FSIS) inspectors. Cattle are carefully examined to identify any symptoms of disease, including signs of central nervous system impairment. Cattle that are suspect for any reason are then re-examined by an FSIS veterinarian to determine whether the animal is eligible for slaughter. No animal that shows signs of systemic illness and disease is allowed into the human food supply.
All cattle slaughtered in federally inspected establishments in the United States are subject to inspection. FSIS inspectors examine cattle to identify any symptoms of disease, including signs of central nervous system impairment.
Cattle that are suspect for any reason are examined by an FSIS veterinarian to determine whether the animal is eligible for slaughter. Cattle that show signs of systemic illness and disease are condemned and not allowed into the human food supply. The brains from animals that exhibit signs of neurological impairment during inspection are submitted for testing and analysis by the USDA's National Veterinary Services Laboratories. The mark of inspection will not be applied to carcasses and parts of cattle selected for BSE testing until the sample is determined to be negative. Only if tests results are negative will the carcass and parts of cattle pass, receive the mark of inspection, and be released into the system.
Since 1989, USDA and other federal agencies have had ongoing regulatory measures in place to prevent BSE contamination of U.S. food and food products. Following the identification in a Washington state dairy herd of a BSE-positive cow imported from Canada, USDA issued new regulations containing additional safeguards to further minimize risk for introduction of the BSE agent into the U.S. food supply. See USDA's website www.usda.gov for further information.
Similarly, FDA has prohibited the use of the cattle materials that carry the highest risk of BSE in human food, including dietary supplements, and in cosmetics. FDA's rule prohibits use of the following cattle material in human food and cosmetics:
- cattle material from non-ambulatory, disabled cattle,
- cattle material from organs from cattle 30 months of age or older in which infectious prions are most likely to occur, and the tonsils and small intestine of cattle of all ages,
- cattle material from mechanically separated (MS) (beef), and
- cattle material from cattle that are not inspected and passed for human consumption
FDA's rule also requires that food and cosmetics manufacturers and processors make available to FDA any existing records relevant to their compliance with these prohibitions. FDA has also published a proposal requiring manufacturers and processors of food and cosmetics made with cattle material to establish and maintain records demonstrating that their products do not contain prohibited cattle material.
A2. USDA's BSE tests are not food safety tests. They are specifically used to determine whether BSE exists in the U.S. cattle population and if so, at what level. It is USDA's position that such testing is valid only for a statistically based surveillance system. It is important to note that the removal of specified risk materials (SRMs) is the single most important action that can be taken to protect public health. Current BSE tests are not accurate for animals that are not showing clinical signs of BSE. One estimate is that current test methodology would have a false negative test rate of 92% for clinically normal adult cattle because prion accumulation is lower than the detection threshold (i.e., if 100 BSE-infected adult cattle were tested while clinically normal, 92% of them would test negative even though they were, in fact, infected).
The goal of the USDA's enhanced surveillance program is to provide consumers, trading partners, and industry increased assurances about animal health, specifically whether BSE exists in the U.S. cattle population and if so, at what level. USDA targets its testing effort on those animals which are most likely to have the disease.
Current testing methodology can detect a positive case of BSE approximately 3 months before the animal begins to demonstrate clinical signs. The incubation period for BSE - the time between initial infection and the manifestation of clinical signs - is generally very long, on average about 4 years. Accordingly, there is a long period during which testing an infected animal with the current methodology would, wrongly, produce negative results. This is especially likely if the animal is clinically normal at the time samples are obtained for testing. One estimate is that current test methodology would have a false negative test rate of 92% for clinically normal adult cattle because prion accumulation is lower than the detection threshold (i.e., if 100 BSE-infected adult cattle were tested while clinically normal, 92% of them would test negative even though they were, in fact, infected). If, however, the animal is exhibiting some type of clinical signs that could be consistent with BSE, then the test is much more meaningful and is not likely to produce false negative results. Since current tests only determine the presence of BSE shortly before the likely onset of symptoms, testing apparently normal animals presented for slaughter is not an effective use of the tests, and again, provides no assurance of food safety.
The OIE is very clear in stating that the likelihood of detecting BSE in cattle varies immensely among cattle sub-populations, and testing healthy cattle at slaughter is the least likely to produce results.
USDA's BSE tests are not food safety tests. They are valid only for a statistically based surveillance system. It is important to note that the removal of specified risk materials (SRMs) is the single most important action that can be taken to protect public health.
A3. USDA has tested more than 200,000 animals since June 1, 2004, and has not found a positive animal yet. There has been only one case of BSE in the United States and it was found in a non-native animal. The enhanced surveillance program still has several months to run and, while none have shown up yet, it is possible that USDA could find an additional case.
A4. USDA regulations ensure that all establishments are responsible for ensuring that SRMs are completely removed from the carcass, segregated from edible products, and disposed in an appropriate manner under their HACCP plans. Regulations also require in-plant sanitation procedures for preventing cross-contamination by SRMs.
Under U.S. regulations, slaughter and processing establishments are required to develop, implement, and maintain written procedures that demonstrate the proper removal, segregation, and disposal of SRMs. FSIS works closely with each establishment to ensure that specific procedures are developed in order to best achieve the requirements of the regulations within that establishment.
Establishments are responsible for ensuring that SRMs are completely removed from the carcass, segregated from edible products, and disposed in an appropriate manner. Establishments must address their control procedures in their HACCP plans, sanitation standard operating procedures, or other prerequisite programs. The rules also require that establishments that slaughter cattle and process the carcasses or parts maintain daily records that document the implementation and monitoring of their procedures for the removal, segregation, and disposition of SRMs and that the establishments make these records available to FSIS personnel on request. To ensure that SRMs are not present in meat, FSIS inspectors verify that establishments are properly removing these tissues.
FSIS also requires in-plant sanitation procedures for preventing cross-contamination by SRMs. When an establishment is slaughtering or processing cattle 30 months of age or older and cattle younger than 30 months of age, inspection program personnel verify that the equipment (e.g., saws and knives) is properly cleaned and sanitized between carcasses and parts. In addition, FSIS maintains a strong regulatory verification-testing program of product produced from advanced meat recovery (AMR) systems to ensure that spinal cord, brain, trigeminal ganglia, and dorsal root ganglia are not present in product labeled as meat. Also, because vertebral column and the skull of cattle 30 months of age and older are considered inedible, these materials cannot be used in AMR systems.
A5. Advanced Meat Recovery (AMR) is still being used but only under certain conditions, and it is carefully monitored. The AMR process cannot be operated in a manner that would contaminate central nervous system tissue (e.g., brain, spinal cord tissue, etc) or excessive amounts of bone solids or bone marrow into meat for human consumption.
Advanced Meat Recovery (AMR) is a technology that removes muscle tissue from the bone of carcasses under high pressure. This process is still being used but only under certain conditions, and it is carefully monitored. The AMR process cannot be operated in a manner to incorporate central nervous system tissue (e.g., brain, trigeminal ganglia, spinal cord tissue, or dorsal root ganglia) or excessive amounts of bone solids (measured by calcium level) or bone marrow (measured by iron level). In March 2003, FSIS began a routine regulatory sampling program to ensure that plants using AMR systems are preventing spinal cord from entering the food supply in products labeled as meat. The sampling program has since been expanded to also test for the presence of dorsal root ganglia in meat derived from beef and pork. Currently, there is no lamb prepared using AMR systems.
Q6. The United States claims that it has been implementing a ban on feeding mammalian proteins to ruminants since 1997, but it still is primarily a ruminant-to-ruminant feed ban. How can you prevent bovine-derived poultry feed, for example, from commingling with cattle feed?
A6. There is a scientific consensus that BSE cannot be transmitted through the use of mammalian origin meat-and-bone meal (MBM) tp swine, poultry, or other non-ruminant species. However, firms that handle or produce feed for ruminants and non-ruminants are required to have separate equipment or facilities or have an adequate cleanout process in order to prevent cross-contamination.
The feed ban's restrictions on the use of mammalian protein apply only to its use in ruminant feed and not to feed for other species. Therefore, mammalian origin meat-and-bone meal (MBM) may be used in feed for swine, poultry, and other non-ruminant species. However, firms that handle material prohibited for ruminants (but allowed for non-ruminants) and also produce ruminant feed are required to have separate equipment or facilities or else have cleanout procedures adequate to prevent cross-contamination. This requirement applies to firms at all levels, from rendering to on-farm mixing. They also are required to clearly label prohibited material as not to be fed to ruminants. Guidance on preventing cross-contamination is available through FDA's Center for Veterinary Medicine.
A7. FDA initiated a feed ban in August 1997. Compliance rates for the first year showed higher than anticipated for a new program with 50-85 percent of the renderers and feed manufacturers in compliance with all aspects of the regulation. The majority of problems were minor, relating to noncompliance of simple documentation requirements as opposed to serious concerns such as the presence of prohibited material. As of July 2004, conditions or practices warranting regulatory sanctions had been found in less than one percent of inspected facilities. Inspection results are posted in a searchable online database. In August, 2005, the U.S. will have had an effective feed ban in place for 8 years, the time period recommended by OIE to effectively mitigate the spread or introduction of BSE within a domestic herd.
In August 1997, FDA projected a 75-percent compliance rate as the feed ban was implemented. The actual compliance rates from October 1997 to September 1998 showed 50-85 percent of the renderers and feed manufacturers in compliance with all aspects of the regulation. Compliance by renderers and feed manufacturers with individual requirements of the regulation varied from 50 to nearly 100 percent. Approximately 95 percent of the producers did not have the prohibited material at their facilities, although only about 25 percent were in compliance with the regulation's documentation requirements.
FDA has continued to conduct inspections to monitor compliance of domestic feed mills, renderers, and protein blenders. FDA also has expanded the scope of its initial inspections to include other segments of animal feed production and use, such as transportation firms, farms that raise cattle, and animal feed salvage operations. Compliance with the feed ban by U.S. feed mills, renderers, and protein blenders currently is very high. As of July 2004, conditions or practices warranting regulatory sanctions had been found in less than one percent of inspected facilities. Inspection results are posted in a searchable online database.
While the United States currently does not ban the use of all SRMs from all animal feeds, we have maintained a ban on the feeding of ruminant SRMs to ruminant animals since 1997. This has been a very effective firewall against the spread of BSE in the United States, as demonstrated by the fact that more than 230,000 animals have been tested under the ongoing enhanced surveillance program without a single positive case. The regulatory measures appropriate for a country are dependent in part on the prevalence of the disease, and all indications are that the prevalence in the United States is extremely low.
We currently are considering whether to take additional measures under the feed ban, but it is important to understand that any actions related to strengthening the feed ban is no reflection on the efficacy of the current system nor will it directly affect the safety of U.S. beef. While we agree that the feed ban is a very important component of our overall BSE management program, the safety of meat exported is ensured by the removal of SRMs?i.e., those tissues at risk of carrying the BSE agent?from all cattle that enter the food supply.
A8. Maturity refers to the physiological age of the animal rather than the chronological age. When chronological age is not known, physiological maturity can be used; the indicators of physiological maturity are bone characteristics, ossification of cartilage, color and texture of ribeye muscle. Cartilage becomes bone, lean color darkens, and texture becomes coarser with increasing age. Cartilage and bone maturity receive more emphasis, because lean color and texture can be affected by other postmortem factors. Grades of maturity progress from A (youngest) to E (oldest).
Cartilage evaluated in determining beef carcass physiological maturity are those associated with the vertebrae of the backbone, except the cervical (neck). Thus, the cartilage between and on the dorsal edges of the individual sacral and lumbar vertebrae as well as the cartilage located on the dorsal surface of the spinous processes of the thoracic vertebrae (buttons). Cartilage in all these areas are considered in arriving at the maturity group. The buttons are the most prominent, softest, and least ossified in the younger carcasses. As maturity proceeds from A to E, progressively more and more ossification becomes evident. Ribs are quite round and red in A-maturity carcasses, whereas E-maturity carcasses have wide and flat ribs. Redness of the ribs gradually decreases with advancing age in C-maturity, and they generally become white in color, because they no longer manufacture red blood cells and remain white thereafter. Color and texture of the longissimus muscle are used to determine carcass maturity when these characteristics differ sufficiently from normal.
There is a posterior-anterior progression in maturity. Thus, ossification begins in the sacral region and, with advancing age, proceeds to the lumbar region and eventually begins in the thoracic region (buttons) of the carcass. Because of this posterior-anterior progression of ossification, even young A-maturity carcasses will have some ossification in the sacral cartilage.
A9. USDA recently conducted a detailed study, in consultation with a GOJ Panel of Experts, of the current U.S. fed beef population to determine the relationship between physiological and chronological age of cattle. Upon completion of the study, it was jointly agreed that data from this study indicated that no carcasses evaluated as equal to or less than A40 were from cattle older than 17 months of age. Consequently, limiting meat to that graded as A40 or below will effectively exclude animals equal to or older than 21 months of age from export to Japan.
USDA recently conducted a detailed study of the current U.S. fed beef population to determine the relationship between physiological and chronological age of cattle. The goal of this study was to verify the ability to exclude animals equal to or older than 21 months of age from export to Japan via the use of the A-Maturity classification system. Factors such as chronological age, sex, breed, and production history were recorded on more than 4,000 cattle that were harvested in November of 2004.
Data analysis from this study showed that cattle 21 months of age and older were physiologically more mature (P < 0.05) than cattle 20 months of age and younger. In addition, data from this study indicated that no carcasses evaluated as equal to or less than A40 were from cattle older than 17 months of age. While this analysis of the data was excessively conservative considering other firewalls that are in place to prevent the transmission of BSE in the United States, and little to no prevalence of the disease in the national herd, it does provide the greatest level of assurance that no products originating from cattle 21 months of age and older will be allowed to be exported to Japan.
A10. Meat grading is currently practiced on more than 95% of the cattle slaughtered in the United States based on a program that has been constantly monitored and improved over the past 30 years. Meat Grading and Certification (MGC) Branch employees (i.e., graders) are evaluated/monitored continually on their ability to accurately assign USDA Quality and Yield grades to carcasses. Expert graders must receive more than 4,000 hours of training and are subject to monthly correlations (tests) and audits by their supervisors. Additional measures will be implemented to assure accuracy and precision of certification requirements for qualifying beef for export to Japan. Included in these additional requirements will be a policy in which expert evaluators for the carcass age verification portion of the USDA Export Verification (EV) Program Specified Product Requirements for Beef - Japan must meet performance measures in order to qualify to certify carcasses as meeting the requirements of this program. All carcasses complying with the physiological maturity requirement of the EV program will be uniquely identified and marked once evaluated and approved. These identification marks will remain with the product through processing, packaging, storage, and shipping to insure the integrity of the process and the product.
Meat Grading and Certification (MGC) Branch employees (i.e., graders) are evaluated/monitored continually on their ability to accurately assign USDA Quality and Yield grades to carcasses. This continual evaluation of graders is essential in maintaining the high level of consistency that is demanded by both consumers and industry.
Maturity evaluations are currently an essential element for the evaluation of quality for each and every carcass that receives a USDA Quality grade. These maturity evaluations are a primary factor used to segregate carcasses into groups that are more homogenous in eating quality. This factor by itself, is not recorded independently, but is assessed in aggregate with other quality grade predictive factors (e.g., marbling score) that each carcass must meet before qualifying for a particular grade. Thus, the grader makes an evaluation of each characteristic prior to determining if the carcass would qualify for any of the possible quality grades.
Supervisors of graders routinely correlate and discuss carcasses with graders to assure uniform and accurate assessment of grade factors. These supervisory reviews are conducted in plants where the grading function is performed to provide accurate assessment of graders ability to conform to performance standards. The results of these correlations and discussions are documented and further discussed with each individual grader.
Random samples of graders' evaluations are selected on a monthly basis, evaluated by a supervisor, and the results charted to evaluate accuracy and provide feedback to individuals as well as groups of employees at multi-grader locations.
In order to attain the level of expert grader, an employee must first receive more than 4,000 hours of training. During periods of beef grading, each grader is required to participate in correlations with his immediate supervisor at least once per month in order to assure uniformity and accuracy in line with the evaluations of his supervisor for grade factors. In addition to the correlation, supervisors conduct on the job discussions relative to factor evaluations during detailed individual review periods for each grader.
Supervisors also conduct internal accuracy audits in different regions of the country on a monthly basis. This activity involves supervisors that are out of the direct chain of command for the selected region reviewing the accuracy of evaluations performed by graders in that location. These observations are documented and presented to the supervisor of direct responsibility, in addition to the technical oversight chain of supervision within the MGC Branch.
Additionally, an independent evaluation of grading accuracy is conducted by a completely independently-run Review Team, which reports directly to the Deputy Administrator of the Livestock and Seed Program. This review is conducted in an unannounced fashion and targets specific plants for a week-long review.
Over the last 30 years, the Standardization Branch has developed and provided training for Meat Grading and Certification Branch personnel for the development of certification programs, which are based on the Official United States Standards of Grades of Carcass Beef. Examples of these types of certification programs include the development of standards for factors such as 1) Small50 marbling, 2) Slight40 marbling, and 3) hump height requirements for various branded beef programs certified by USDA.
We intend to implement additional measures to assure accuracy and precision of certification requirements for qualifying beef for export to Japan. Included in these additional requirements will be a policy in which expert evaluators for the carcass age verification portion of the USDA Export Verification (EV) Program Specified Product Requirements for Beef - Japan must meet performance measures in order to qualify to certify carcasses as meeting the requirements of this program.
All carcasses complying with the physiological maturity requirement of the EV program will be uniquely identified and marked once evaluated and approved by proficiency-tested expert evaluators as meeting specified Japanese requirements. These identification marks will remain with the product through processing, packaging, storage, and shipping to insure the integrity of the process and the product.
A11. vCJD is a variant on the most common transmissible spongiform encephalopathy (TSE) found in humans, called Creutzfeldt-Jakob disease (CJD). This disease is strongly linked to exposure, probably through food, to BSE. The risk for acquiring vCJD from the consumption of meat and meat-based products derived from cattle is very low when all appropriate measures to minimize human exposure are fully implemented and controlled?e.g., SRM removal. As of December 1, 2003, there had been 153 cases of vCJD reported worldwide?143 reported cases in the United Kingdom; six in France; and one case each in the United States, Canada, Ireland, and Italy. In 2004, concerns were raised that a suspected cluster of deaths caused by CJD might have resulted from consumption of meat contaminated with the BSE agent served at restaurants in the Garden State Racetrack in Cherry Hill, New Jersey. The investigation conducted determined that there was no evidence indicating that any of the racetrack-associated deaths resulted from vCJD or that they were causally linked with the consumption of BSE-contaminated meat.
The CDC, in its review of BSE and vCJD, has said that, in the UK which has experienced the majority of BSE cases, the current risk of acquiring vCJD from eating beef and beef products appears to be extremely small, perhaps about 1 case per 10 billion servings.
In humans, the most common transmissible spongiform encephalopathy (TSE) is called Creutzfeldt-Jakob disease (CJD). CJD is rare, with a worldwide incidence of one case per million. First described in 1996 in the United Kingdom, variant CJD (vCJD) is similar to CJD as it, too, is a TSE. However, it differs from classical CJD in notable ways. First, in contrast to the classical forms of CJD, vCJD affects younger people (averaging 29 years of age, as opposed to 65 years with CJD). Second, the disease has a relatively longer duration of illness (with a median of 14 months, as opposed to 4.5 months). Finally, it is strongly linked to exposure, probably through food, to BSE. Other human TSEs, including CJD, have not been linked to food exposure. The risk for acquiring vCJD from the consumption of meat and meat-based products derived from cattle is very low when all appropriate measures to minimize human exposure are fully implemented and controlled?e.g., SRM removal. As of December 1, 2003, there had been 153 cases of vCJD reported worldwide?143 reported cases in the United Kingdom; six in France; and one case each in the United States, Canada, Ireland, and Italy.
In the United States, the Centers for Disease Control and Prevention (CDC) leads a surveillance system for vCJD and, to date, has not detected vCJD in any resident of the United States that has not lived in or traveled to the United Kingdom for extended periods of time. In 2002, a probable case of vCJD was reported in a Florida resident who had lived in the United Kingdom during the BSE epidemic. Epidemiological data indicate that the patient likely was exposed to the BSE agent in the United Kingdom before moving to the United States.
In 2004, concerns were raised that a suspected cluster of deaths caused by CJD might have resulted from consumption of meat contaminated with the BSE agent served at restaurants in the Garden State Racetrack in Cherry Hill, New Jersey. The investigation conducted determined that there was no evidence indicating that any of the racetrack-associated deaths resulted from vCJD or that they were causally linked with the consumption of BSE-contaminated meat.
Q12. With respect to trade between the United States and Canada, now that Canada has found 3 BSE cases (4 including the one found in Washington state), how will the United States ensure that no BSE-infected animals will enter the United States when the U.S.-Canadian border opens?
On December 29, 2004, USDA released a final rule that establishes criteria for geographic regions to be recognized as presenting minimal risk of introducing BSE into the United States. These criteria established the requirements for allowing imports of meat and live animals from Canada. The United States is very confident that the combination of the rule's requirements, in addition to the animal and public health measures that Canada has in place to prevent the spread of BSE, along with the extensive U.S. regulatory food-safety and animal-health systems, will provide a high level of protection for the U.S. consumers and livestock.
The rule provides for the slaughtering of Canadian-origin cattle at a young age (i.e., under 30 months of age). Moreover, the tonsils and the distal ileum from these cattle will be removed and prohibited from use in human food, as these tissues are considered SRMs at all ages. These measures are the most effective means for protecting consumers. Animals not imported for immediate slaughter will be carefully monitored.
On December 29, 2004, USDA released a final rule that establishes criteria for geographic regions to be recognized as presenting minimal risk of introducing BSE into the United States. It places Canada in the minimal-risk category and defines the requirements that must be met for the import of certain ruminants and ruminant products from Canada. A minimal-risk region can include a region in which BSE-infected animals have been diagnosed, but where sufficient risk-mitigation measures have been put in place to make the introduction of BSE into the United States unlikely.
Under this rule, cattle will have access to the United States for the first time since May 2003 when access was banned, as long as they are slaughtered at less than 30 months of age and as long as those cattle not imported for immediate slaughter are moved to a single feedlot before slaughter. It also was to allow access for imports of meat from animals 30 months and over. However, on February 9, 2005, USDA Secretary Johanns announced that he would delay the effective date for allowing imports of meat from animals 30 months and over. This decision addresses concerns over the portion of the minimal-risk rule that would reopen the Canadian border for beef from animals 30 months and over, while keeping it closed for imports of older live cattle for processing in the United States. Now, live animals under the age of 30 months and meat from animals under the age of 30 months are eligible for importation, effective March 7.
The United States remains very confident that the combination of the rule's requirements, in addition to the animal and public health measures that Canada has in place to prevent the spread of BSE, along with the extensive U.S. regulatory food-safety and animal-health systems, provide the protection to U.S. consumers and livestock.
As the incubation period for BSE is very long?i.e., approximately five years?cattle exposed to the BSE agent during this period show no symptoms and, until late in the period, have no infectious material in their tissues. The rule provides for the slaughtering of Canadian-origin cattle at a young age (i.e., under 30 months of age). Moreover, the tonsils and the distal ileum from these cattle will be removed and prohibited from use in human food, as these tissues are considered SRMs at all ages. These measures are the most effective means for protecting consumers.
Q13. A recent Government Accountability Office (GAO) report found that 19 percent of the feed industry has not been re-inspected in the past five years. How can the FDA ensure the Japanese people that U.S. cattle are not consuming meat-and-bone meal?
A13. To maximize enforcement of the ruminant feed ban, FDA inspects firms (renderers, feed mills, etc.) considered to be of highest risk more frequently than low risk firms. High-risk firms are those which manufacture, or process feeds or feed ingredients containing prohibited meat-and-bone meal (which is allowed for non-ruminants). High-risk firms are inspected at least once every year to ensure their compliance with FDA requirements preventing cross contamination.
Low risk firms are those that purchase feed or feed ingredients from high-risk firms, but do not further process or re-manufacture the feed or feed ingredients. For most of these firms there is no commercial handling of meat-and-bone meal since they are handling only packaged products like pet food. As a result, it would be highly unlikely that cattle would have access to any of these products.
Once FDA has established through inspection that these firms do not manufacture or process feeds containing meat-and-bone meal, the frequency of re-inspection is reduced so that greater enforcement activities can be focused on the high-risk firms. The 19 percent of the feed industry cited in the GAO report consist entirely of low risk firms.
A14. USDA does not tolerate any breach in our SRM removal process because we recognize that it is the key to ensuring food safety. The chairman of the National Joint Council of Food Inspection Locals made unsubstantiated and nonspecific allegations pertaining to SRM removal in a letter and public statements to news media. All allegations brought to USDA are vigorously and thoroughly investigated. In this case, despite repeated requests, the Chairman has declined to provide any specifics about where or when these incidents took place. In subsequent reviews of the SRM removal process, USDA/FSIS has not found any significant problems.
A15. Recent media reports suggesting two U.S. cows might not have been properly tested for BSE in 1997 are in error. Both cows were tested multiple times in government laboratories. BSE was definitely ruled out in both cases. A story by the UPI (4/15) reports that the people who made the allegations did so before they were in possession of all of the facts. Once these individuals had the needed information, they were satisfied that the cows were not infected with BSE.
A16. The incident of a small amount of beef mixed with a shipment of pork to Japan has been investigated. The inclusion of beef was inadvertent, but the two establishments responsible have been issued letters of warning by USDA's Food Safety Inspection Service.
A17. The U.S. is taking great care to ensure that only meat from animals 20 months of age and younger will be exported to Japan. This will be verified in one of two ways.
The first way is through the use of animals whose age is known. The current supply of known age cattle available for slaughter is limited; however, since the fall of 2004, a growing number of producers have been documenting the date of birth, thus the numbers of cattle with known age will continue to increase in the next 6 to 12 months. However, as the market to Japan reopens, the demand for cattle of known age will drive more livestock operations to begin maintaining the data needed to meet these criteria.
The second way is through the use of the physiological maturity in the current grading system. This system was accepted by Japan's expert panel as a valid method to ensure that only animals 20 months of age and younger would be exported from the U.S. to the Japanese market. In fact, our studies demonstrate that this system will actually provide a 3 month buffer when the physiological maturity threshold is set at the A40, as all animals in that physiological maturity group were 17 months of age and younger. The graders responsible for this program are highly experienced professionals who have received well over 4,000 hours of training.
A18. In the 1940s, the predecessor agency of the U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) initiated an extensive program to identify cattle tested and vaccinated for the disease brucellosis. The official brucellosis tag and ear tattoo provided the United States with a highly successful animal identification program for cattle for decades. Since brucellosis is close to being eradicated in the United States, however, that system of tagging and identification is being phased out rapidly. Several other animal health programs include an animal identification component, and certain classes of livestock must be officially identified before entering interstate commerce. In addition, some animals must be identified before they can compete in shows or race on a track. So, there are multiple identification systems in place that exist for different purposes, but until the initiation of the NAIS, there was no nationwide animal identification system for all animals of any given species.
The plan for implementing the NAIS was already well underway when a case of bovine spongiform encephalopathy was detected in the United States in December 2003. With that in mind, USDA announced shortly after the finding that it would expedite the implementation of a verifiable national animal identification system. The NAIS has evolved over the course of several years with input from many sources. It continues to be refined and improved.
USDA is building upon existing identification systems and allowing for a transition period from systems currently being used.
A19. It is important to look at the scientific information on testing that is available. It takes the prions more than 30 months to migrate to the area of the brain that is tested unless there are extremely high levels of infectivity. This has been proven both clinically with feeding trials and in real life, in Europe, where millions of animals have been tested for BSE.
We are aware of the Japanese identification of the 21 and 23 month-old animals as being infected with BSE. However, to our understanding, their positive tests have yet to be replicated or confirmed by any laboratory outside of Japan. It is important that all countries work cooperatively and share knowledge on this important issue. We encourage Japan to share samples of the infected material with the international BSE community and release the data from the confirmatory mouse assay tests that we understand are in their final stages.
A20. BSE testing at cattle should only be conducted for the purposes of surveillance for disease - to determine if BSE is present in a population, and if so, at what level. It is not appropriate to use testing as a means of assuring food safety. The reason for this is although a positive test means that an animal does have BSE, a negative test does not mean the animal does not have BSE. This is due to the fact that BSE has a lengthy incubation period (the time between when an animal is exposed to the infective agent and when the test can detect it) which may be up to 4 years. Therefore, if an animal is tested during the incubation period, the animal will test negative although it may indeed have BSE. Our consumers would consider it a breach of faith if we allowed the promulgation of something that gives false food safety assurances. The most important measure to protect food safety, is not 100% testing, but the removal of SRMs.
A21. The U.S. has expressed its disappointment to the EU over this determination, which was based on unsubstantiated assumptions and uses worst-case scenarios without proper justification. In fact, we feel that the U.S. has learned many lessons over the past 15 years from GBR III countries with demonstrated risks (as in Europe). We used this information to develop a strong BSE control program that ensures that the risk to consumers in the U.S. is negligible.
More specifically, we implemented BSE control measures such as an import ban and a feed ban long before the 1st case of BSE was discovered in Canada. As a result, despite extensive surveillance, BSE has never been disclosed in an animal born in the United States. Also the U.S. and Canada both implemented multiple BSE controls to prevent the spread of BSE in North America. That is why the U.S. has had no domestic cases of BSE except for one Canadian cow, and why Canada has had only 4 cases confined to a small geographical area.
FSIS - Food Safety Inspection Service
HACCP - Hazard Analysis and Critical Control Points