Federal Register: November 4, 2003 (Volume 68, Number 213)
DOCID: FR Doc 03-27611
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
CFR Citation: 9 CFR Parts 93, 94, and 95
Docket ID: [Docket No. 03-080-1]
RIN ID: RIN 0579-AB73
NOTICE: PROPOSED RULES
ACTION: Exportation and importation of animals and animal products:
DOCUMENT ACTION: Proposed rule.
SUBJECT CATEGORY:
Bovine Spongiform Encephalopathy; Minimal Risk Regions and Importation of Commodities
DATES: We will consider all comments that we receive on or before January 5, 2004.
DOCUMENT SUMMARY:
We are proposing to amend the regulations regarding the importation of animals and animal products to recognize a category of regions that present a minimal risk of introducing bovine spongiform encephalopathy (BSE) into the United States via live ruminants and ruminant products, and are proposing to add Canada to this category. We are also proposing to allow the importation of certain live ruminants and ruminant products and byproducts from such regions under certain conditions. We believe this action is warranted because it would continue to protect against the introduction of BSE into the United States while removing unnecessary prohibitions on certain commodities from Canada and other regions that qualify as BSE minimalrisk regions.
SUMMARY:
Bovine spongiform encephalopathy; minimal risk regions and importation of commodities,
SUPPLEMENTAL INFORMATION
Background
The Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA or the Department) regulates the importation of animals and animal products into the United States to guard against the introduction of animal diseases. The regulations in 9 CFR parts 93, 94, 95, and 96 (referred to below as the regulations) govern the importation of certain animals, birds, poultry, meat, other animal products and byproducts, hay, and straw into the United States in order to prevent the introduction of various animal diseases, including bovine spongiform encephalopathy (BSE).
BSE is a progressive neurological disorder of cattle that results from infection by an unconventional transmissible agent and is not known to exist in the United States. The disease has been difficult to define experimentally with precision, although risk factors that are independent of the causative agent have been identified and can be mitigated. Much of the available data originated from epidemiological observations and not from controlled studies. Controlled studies are often difficult to conduct because of limitations in experimental models and the length of time necessary to conduct the studies, which may require years. Currently, the most accepted theory is that the agent is a modified form of a normal cell surface component known as prion protein, although other types of agents have been implicated, including virinos. The pathogenic form of the protein is both less soluble and more resistant to degradation than the normal form. The BSE agent is extremely resistant to heat and to normal sterilization processes. It does not evoke any demonstrated immune response or inflammatory reaction in host animals.
Despite the difficulty in defining BSE experimentally with precision, risk factors for BSE that can be mitigated have been identified. These factors are based on technical knowledge and disease epidemiology and do not require definition of the nature of the agent. We believe that risk mitigation measures that address the risk factors for BSE will be effective regardless of the precise nature of the BSE agent.
It appears that BSE is spread primarily through the use of ruminant feed containing protein and other products from ruminants infected with BSE. Ruminants in the United States could be exposed to the disease if materials carrying the BSE agentsuch as certain meat, animal products, or animal byproducts from ruminantswere imported into the United States and were fed to ruminants in this country. BSE could also be introduced into the United States if ruminants with BSE were imported into the United States.
Because of these risks, the regulations prohibit the importation of
live ruminants and certain ruminant products and byproducts from two
categories of regions: (1) Those regions in which BSE is known to
exist, which are listed in Sec. 94.18(a)(1) of the regulations; and
(2) those regions that present an undue risk of introducing BSE into
the United States because their import requirements are less
restrictive than those that would be acceptable for import into the
United States and/or because the regions have inadequate surveillance. These regions of ``undue
[[Page 62387]]
risk'' are listed in Sec. 94.18(a)(2) of the regulations.
The prohibitions on the importation of animals, meat, and other animal products into the United States from regions listed in Sec. 94.18(a)(1) or (a)(2) are set forth in 9 CFR parts 93, 94, 95, and 96. Section 93.401 prohibits the importation of any ruminant that has been in these regions. Except for certain controlled transit movements, paragraph (b) of Sec. 94.18 prohibits the importation of fresh (chilled or frozen) meat, meat products, and most other edible products of ruminants that have been in any of the regions. Paragraph (c) of Sec. 94.18 restricts the importation of gelatin derived from ruminants that have been in any of the regions. Section 95.4 prohibits or restricts the importation of certain byproducts from ruminants that have been in any of the regions, and Sec. 96.2 prohibits the importation of casings, except stomach casings, from ruminants that have been in any of the regions.
Essentially then, under the current regulations, there are three categories of regions with regard to BSE. Currently, a region is considered either: (1) A region free of BSE; (2) a region in which BSE is known to exist; or (3) a region that presents an undue risk of BSE. Imports from free regions are generally not subject to restrictions because of BSE. Imports from BSEaffected regions and those that present an undue risk are governed by the same set of restrictions.
We believe it is appropriate to recognize an additional category of regions with regard to BSEthe BSE minimalrisk region. This category would include (1) those regions in which a BSEinfected animal has been diagnosed, but in which measures have been taken that make it unlikely that BSE would be introduced from the region into the United States, and (2) those regions that cannot be considered BSE free even though BSE has not been detected, but that have taken sufficient measures to be considered minimal risk. For instance, a region listed in Sec. 94.18(a)(2) as an ``undue risk'' region might have increased its levels of surveillance or import restrictions to the point that the risk of BSE introduction from that region becomes unlikely, but not yet have had mitigation measures in place long enough to be considered BSEfree.
In Sec. 94.0, we would define bovine spongiform encephalopathy (BSE) minimalrisk region by listing the factors we would consider in determining the region's risk status. In a new Sec. 94.18(a)(3), we would list the regions that the Administrator has approved for this designation. At this time, we are proposing to designate one country, Canada, as a BSE minimalrisk region according to the newly proposed factors. (These factors, and the reasons why we believe Canada meets them, are discussed in detail below.) In Sec. 94.18(a)(4), we would explain that a region may request to be designated a BSE minimalrisk region by following the procedures set forth in our regulations in 9 CFR part 92, ``Importation of Animals and Animal Products: Procedures for Requesting Recognition of Regions.''
Canada as a BSE MinimalRisk Region
On May 20, 2003, the Canadian Food Inspection Agency reported a case of BSE in a beef cow in northern Alberta. Therefore, in order to prevent the introduction of BSE into the United States, we published an interim rule on May 29, 2003 (68 FR 3193931940, Docket No. 030581), effective retroactively to May 20, 2003, to add Canada to the list of regions where BSE exists. As a result of that action, the importation of ruminants that have been in Canada and the importation of meat, meat products, and certain other products and byproducts of ruminants that have been in Canada are prohibited or restricted.
Following the detection of the BSEinfected cow, Canada conducted an epidemiological investigation of the BSE occurrence, and took action to guard against any spread of the disease, including the quarantining and depopulation of herds and animals determined to possibly be at risk for BSE. Subsequently, Canada asked APHIS to consider reestablishing the importation of ruminants and ruminant products into the United States from that country, based on information made available to APHIS regarding Canada's veterinary infrastructure, disease history, practices for preventing widespread introduction, exposure, and/or establishment of BSE, and measures taken following detection of the disease.
In this document, we are proposing to list Canada as a BSE minimal risk region based on an analysis we conducted of the conditions considered for such a designation and the information available to us regarding how Canada meets those conditions. The risk document, ``Risk Analysis: BSE Risk from Importation of Designated Ruminants and Ruminant Products from Canada into the United States,'' also identifies the measures we believe are necessary to mitigate any BSE risk that specific commodities imported from Canada might present to the United States (discussed in this proposed rule, below, under the heading ``Importation of Ruminant Commodities from a BSE MinimalRisk Region'').
You may view the analysis in our reading room (information on the location and hours of the reading room is provided under the heading ADDRESSES at the beginning of this proposed rule). You may also request a copy by calling or writing to the person listed under FOR FURTHER INFORMATION CONTACT. Please refer to the title of the analysis when requesting copies. You may also view the analysis on the Internet by accessing the APHIS Web site at http://www.aphis.usda.gov. At the APHIS Web site, click on the ``Hot Issues'' button. On the next screen, click on the listing for ``Bovine Spongiform Encephalopathy (BSE).'' On the next screen, click on the listing for ``Risk Analysis: BSE Risk from Importation of Designated Ruminants and Ruminant Products from Canada into the United States.''
In this proposed rule, we first discuss the factors we would consider in classifying a region as a BSE minimalrisk region. We would consider these factors in considering requests from any region to be classified as a BSE minimalrisk region. We then discuss why we believe Canada qualifies as a BSE minimalrisk region. Following that, we discuss mitigations that we would apply to specific commodities from Canada.
Proposed Factors for BSE MinimalRisk Regions
APHIS has developed a list of factors we would use to evaluate the
BSE risk from a region and classify a region as a BSE minimalrisk
region. We would use these factors as a combined and integrated
evaluation tool. We are proposing to base the classification on an
evaluation of the sum total of these factors, focusing on overall
effectiveness of control mechanisms in place (e.g., surveillance,
import controls, and a ban on the feeding of ruminant protein to
ruminants). For regions in which BSE has been diagnosed, we would base
our evaluation on the overall effectiveness of such control mechanisms
in place at the time BSE was diagnosed in the region, and on actions
taken after the diagnosis (e.g., an epidemiological investigation of
the occurrence). For regions in which BSE has not been diagnosed, we
would base our evaluation on the adequacy of surveillance mechanisms to
detect disease, efficacy of a feed ban, and effectiveness of programs
in place to prohibit entry into and establishment of disease in the
region. This approach differs from some of the numerical criteria specified by the Office
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International des Epizooties (OIE) in its recommendations for a BSE
minimalrisk country or zone. (The OIE recommendations are recognized
by the World Trade Organization as international recommendations for animal disease control.)
For example, according to OIE recommendations, a ban on the feeding
of ruminant protein to ruminants should have been in place for a
minimum of 7 years for a region to meet the criteria for BSE minimal
risk, even though there is a significant level of variability in
current estimates of the BSE incubation period, which should govern the
recommended length of time of an effective feed ban. According to this
criterion, a region could fail to be classified as a BSE minimalrisk
region because it had not had a feed ban in effect for the precise
period of time specified, even if it has excelled in surveillance and
control mechanisms. We believe it is more appropriate to evaluate the
overall combined effect of the factors described below when assessing the BSE risk level of a region.
Definition of Bovine Spongiform Encephalopathy MinimalRisk Region
We propose to define bovine spongiform encephalopathy (BSE) minimalrisk region in Sec. 94.0 to mean a region that:
1. Maintains, and, in the case of regions where BSE was detected, had in place prior to the detection of BSE, risk mitigation measures adequate to prevent widespread exposure and/or establishment of the disease. Such measures include the following:
a. Restrictions on the importation of animals sufficient to minimize the possibility of infected ruminants being imported into the region, and on the importation of animal products and animal feed containing ruminant protein sufficient to minimize the possibility of ruminants in the region being exposed to BSE;
b. Surveillance for BSE at levels that meet or exceed OIE recommendations for surveillance for BSE; and
c. A ban on the feeding of ruminant protein to ruminants that appears to be an effective barrier to the dissemination of the BSE infectious agent, with no evidence of significant noncompliance with the ban.
2. In regions where BSE was detected, conducted an epidemiological investigation following detection of BSE sufficient to confirm the adequacy of measures to prevent the further introduction or spread of BSE, and continues to take such measures.
3. In regions where BSE was detected, took additional risk mitigation measures, as necessary, following the BSE outbreak based on risk analysis of the outbreak, and continues to take such measures.
Each element of this definition is explained below.
1. The region maintains, and, in the case of regions where BSE was detected, had in place prior to the detection of BSE, risk mitigation measures adequate to prevent widespread exposure and/or establishment of the disease.
This factor is important in determining those regions in which a BSE outbreak is unlikely to occur, or, if an outbreak does occur, in which it is likely to be limited. If a region maintains controls designed to minimize BSE introduction or exposure of animals, and, in those regions where BSE has been detected, if the region had such controls in place at the time of detection, it is more likely to present minimal risk than a region that does not have such controls in place. According to our definition of a BSE minimalrisk region, such measures would include importation restrictions, surveillance, and a feeding ban, as follows:
1a. Restrictions on the importation of animals sufficient to minimize the possibility of infected ruminants being imported into the region, and on the importation of animal products and animal feed containing ruminant protein sufficient to minimize the possibility of ruminants in the region being exposed to BSE.
This factor addresses whether the region faces a high risk of initial or recurrent BSE outbreaks from multiple importations of animals or products that may spread BSE. In those regions in which BSE has been detected, it addresses whether the region's BSE outbreak was more likely the result of a point failure in its import controls or possible exposure prior to the implementation of such import controls. Because the incubation period for BSE is generally measured in years, the finding of a case of BSE reflects an exposure that occurred several years in the past.
A region that has prohibited the importation of highrisk animals and products from regions that are affected with or pose an undue risk of BSE will have minimized its possible exposure to the disease. Conversely, a region that continues to import highrisk commodities until a case of BSE is diagnosed has continued exposure and presents a more significant risk. Whether commodities are considered lowrisk or highrisk can be based on the commodities' inherent lack of risk, the low risk level of the exporting region, and/or controls on the movement and use of the commodities after entry.
1b. Surveillance for BSE at levels that meet or exceed OIE recommendations for surveillance for BSE.
This factor addresses whether BSE outbreaks are or would be likely to be quickly and reliably identified in a region, helping support a minimalrisk designation, or whether lack of effective surveillance suggests the possibility that BSEinfected animals may be overlooked and the scale of a BSE problem may be greater than is officially recognized.
As noted above, the OIE recommendations are recognized by the World Trade Organization as international recommendations for animal disease control. The OIE Code provides guidelines for surveillance and monitoring systems for BSE, identifying the minimum number of annual investigations recommended based on the adult cattle population of a country.
1c. A ban on the feeding of ruminant protein to ruminants that appears to be an effective barrier to the dissemination of the BSE infectious agent, with no evidence of significant noncompliance with the ban.
The primary source of BSE infection appears to be feed contaminated
with the infectious agent. Scientific evidence \1\ shows that feed
contamination results from the incorporation of ingredients that
contain ruminant protein derived from infected animals. Standard
rendering processes do not completely inactivate the BSE agent.
Therefore, rendered protein such as meatandbone meal derived from
infected animals may contain the infectious agent. Bans prohibiting
incorporation of mammalian or ruminant protein into ruminant feed are imposed to mitigate risk.
\1\ Wilesmith, J.W., Wells, G.A.H., Cranwell, M.P., and Ryan,
J.B.M.; 1988; Bovine spongiform encephalopathy; epidemiological studies; Veterinary Record; 123, pg 638644.
Wilesmith, J.W., Ryan, J.B.M, and Atkinson, M.J.; 1991; Bovine spongiform encephalopathy; epidemiological studies of the origin; Veterinary Record; 128, pg 199203.
Wilesmith, J.W., Ryan, J.B.M, and Hueston W.D.; 1992; Bovine spongiform encephalopathy: Case control studies of calf feeding practices and meatandbone meal inclusion in proprietary
concentrates; Res Vet Sci; 52, pg 325331.
This factor distinguishes between regions with effective feed bans and those without them. In a region in which BSE has been detected, if an animal with BSE was born after a feed ban was implemented, it is a sign that the feed ban may not be effectively enforced.
2. In a region in which BSE has been detected, the region conducted an
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epidemiological investigation following detection of BSE sufficient to
confirm the adequacy of measures to prevent the further introduction or spread of BSE, and continues to take such measures.
This factor addresses whether a region adequately investigates a case of BSE to determine if any of the risk factors have changed. If there has been any significant change in risk factors, there might be the possibility of increased incidence of BSE. Such an investigation would include, at the minimum, a traceback from the BSEinfected animal to determine possible herds of origin of the animal, a traceforward of any animals that moved from the BSEaffected herd, a traceforward of feed or rendered material that was derived from the carcass of the infected animal, and an investigation to determine the most likely source of the animal's exposure to BSE.
3. In a region in which BSE has been detected, the region took additional risk mitigation measures, as necessary, following the BSE outbreak based on risk analysis of the outbreak, and continues to take such measures.
This factor addresses whether a region implements all necessary risk mitigation measures to prevent further exposure to BSE. It distinguishes between those regions that thoroughly analyze their situation and address any problems from those that do not take mitigation measures and thus prolong possible exposure to BSE. Depending on the conclusions of the risk analysis conducted following the diagnosis of BSE, additional risk mitigation measures could include a broad eradication program, increased surveillance, or additional import restrictions.
Evaluating Canada as a BSE MinimalRisk Region
We considered the above factors in combination in evaluating whether Canada qualifies as a BSE minimalrisk region, and discuss below the actions Canada took and continues to take regarding each of the factors.
Import Restrictions
Canada has maintained stringent import restrictions since 1990,\2\
prohibiting the importation of live ruminants and most ruminant
products from countries that had not been recognized as free of BSE by
either the United States, Canada, or Mexico, which have an agreement to
recognize country evaluations conducted by any of the three countries,
using the same standards. Canada prohibited the importation of live
cattle from the United Kingdom and the Republic of Ireland starting in
1990, and subsequently applied the same prohibitions to other countries
as those additional countries identified native cases of BSE. In 1996,
Canada made this policy even more restrictive and prohibited the
importation of live ruminants from any country that had not been
recognized as free of BSE. Some animals were imported into Canada from
highrisk countries prior to the imposition of these import
restrictions. A total of 182 cattle were imported into Canada from the
United Kingdom between 1982 and 1990. Similar to actions taken in the
United States, efforts were made in Canada to trace these animals. In
late 1993, after Canada identified a case of BSE in one of the imported
bovines, all cattle imported from the United Kingdom or the Republic of Ireland that remained alive at that time were killed.
\2\ Canadian Food Inspection Agency (CFIA), December 2002; Risk
Assessment on Bovine Spongiform Encephalopathy in Cattle in Canada.
Morley, R.S., Chen, S., Rheault, N.; 2003; Assessment of the risk factors related to bovine spongiform encephalopathy; Rev. Sci. Tech. OIE; 22(1); pg 157178.
Import restrictions have also been imposed on ruminant products, including import restrictions on meatandbone meal that have been in place since 1978. In general, Canada has prohibited the importation of most meatandbone meal from countries other than the United States, Australia, and New Zealand. Limited amounts of specialty products of porcine or poultry origin were allowed to be imported into Canada under permit for use in aquaculture feed products. No meatandbone meal for livestock feedassociated uses has been imported, except from the United States, Australia, and New Zealand.
Surveillance
Canada has conducted surveillance for BSE since 1992. The OIE Code,
Appendix 3.8.4, provides guidelines for surveillance and monitoring systems for BSE, identifying the minimum number of annual
investigations recommended based on the adult cattle population of a
country. To meet this recommendation, Canada would have to test a
minimum of 336 samples annually, based on a population of 5.5 million
adult cattle. Canada exceeds this recommendation, and has tested more
than this minimum number of samples for the past 7 years. Additionally,
Canada exceeds OIE recommendations by conducting active targeted
surveillance. (Active targeted surveillance involves sampling animals
with risk factors for BSE, even if the animals have not shown clinical signs of disease.)
Feed Ban
Canada implemented a feed ban in 1997 that prohibits the feeding of most mammalian protein to ruminants. This ban exceeds what we consider the minimal necessary measure of banning the feeding of ruminant material to ruminants. Under the ban in Canada, mammalian protein may not be fed to ruminants, with certain exceptions. These exceptions include pure porcine or equine protein, blood, milk, and gelatin. The feed ban is essentially the same as the feed ban in place in the United States.
APHIS believes the length of the feed ban in Canada is sufficient to classify that country as a minimalrisk region for BSE. In comparison, classification as a minimalrisk country or zone by OIE criteria requires that a feed ban be in place for 8 years. This value may be set at a conservative level to account for the wide range that has been reported for the incubation period of BSE. Because of the variability in the incubation period for BSE, APHIS chose not to specify an amount of time that a feed ban needed to be in place in a minimalrisk region. Rather, we considered the sum total of the control mechanisms (e.g., effectiveness of surveillance, import controls, and feed ban) in place at the time of the diagnosis of BSE and the actions taken subsequently (e.g., epidemiological investigations and depopulation), thereby allowing the actions Canada took with regard to the other factors to compensate for a shorter feed ban. As an example, as discussed above, the level of surveillance in Canada, and the fact that it has been active and targeted, has exceeded OIE recommendations.
Canadian Government authorities inspect rendering facilities, feed
manufacturers, and feed retailers to ensure compliance with the feed
ban. Rendering facilities are regulated under an annual permit system,
and compliance with the regulations is verified through at least one
inspection each year. Feed manufacturers or mills, feed retailers, and
farms have been inspected on a routine basis. These inspections have
shown a high level of compliance. As noted above, Canada has maintained
an effective ban on feeding mammalian protein to ruminants, with
requirements similar to the feed ban in place in the United States,
since 1997. The animal in which BSE was diagnosed in May 2003 was an 6
yearold nativeborn beef cow in the Province of Alberta that was born before the implementation of the feed ban.
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Epidemiological Investigation
Canada conducted an extensive epidemiological investigation after the one case of BSE in May 2003. This investigation included detailed tracebacks to identify possible herds of origin of the infected animal, traceforwards from the infected herd, and traceforwards of any possible feed or rendered material derived from the carcass of the infected animal. Fifteen premises were quarantined as part of the traceback and traceforward investigations, and cattle on the quarantined premises were slaughtered. Additionally, cattle that were determined to have moved from a quarantined herd to another herd were slaughtered.
The investigation included any possible exposure from the use of rendered material or feed that could have been derived from the carcass of the infected cow. Using a broad definition to include all possible exposures, the rendered material could have been distributed to approximately 1,800 sites, including sites with no ruminants. These included 600 facilities that receive bulk shipments of either rendered protein or feed, and 1,200 individual producers or consumers who purchased finished feed by the bag. A survey was conducted of those entities that were at some risk of having received such rendered material or feed. This survey suggested that 99 percent of the sites surveyed experienced either no exposure of cattle (96 percent of the sites) to the feed or only incidental exposure (3 percent of the sites). The remaining 1 percent represented limited exposures, such as cattle breaking into feed piles, sheep reaching through a fence to access feed, and a goat with possible access to a feed bag.
The investigation included a consideration of several possibilities for the source of the infected cow's exposure to BSE. Although it has not been confirmed, it is assumed, based on the age of the cow, that the infected cow was exposed through contaminated feed. The infected animal was born prior to the implementation of a feed ban within Canada and could have had exposure to contaminated feed at an early age.
The renderers and feed mills associated with the investigation had records of good compliance with the feed ban. The onfarm inquiries demonstrated a very small probability of exposure of ruminants to prohibited feed. Although the possibility exists that the original source of the BSE agent could have been imported, there was no evidence that this was due to an illegal import. The BSE agent could have been from animals imported from the United Kingdom prior to import restrictions established in 1990. The surveillance program was sufficient to confirm the continued existence of adequate measures to prevent further introduction or spread of BSE.
Additional Risk Mitigation Measures
Following the detection of BSE in Canada, a broad eradication
program was followed during the epidemiological investigation, in which
more than 2,700 head of cattle were culled. As part of the culling
activity, more than 2,000 animals 24 months of age or older were tested
(those animals less than 24 months of age were not tested), with no further evidence of BSE found in any of these animals.
Importation of Ruminant Commodities From a BSE MinimalRisk Region
Because we believe regions, such as Canada, that qualify as BSE minimalrisk regions based on the factors described above, would pose a minimal risk of introducing BSE into the United States, we believe it is warranted to allow the importation from such regions of some animals and animal products and byproducts that are prohibited importation from regions in which BSE exists and regions that present an undue risk of BSE. However, because BSE is a difficult disease to define experimentally with precision, epidemiological evidence suggests that risk factors are specific to the commodity, and multiple risk sources may be associated with a given commodity, we believe it is necessary to also apply individual risk mitigation measures to specified commodities intended for importation from BSE minimalrisk regions.
For example, as noted above and discussed further below, contaminated feed appears to be the most likely pathway of BSE transmission. However, it has not been established with certainty that contaminated feed is the only pathway. Furthermore, we cannot assume complete compliance with a ban on the feeding of ruminant protein to ruminants, which is the most effective mitigation for contaminated feed. Therefore, we believe it is necessary to apply certain other mitigation measures, in addition to implementation of a feed ban, to reduce the risk of the introduction of BSE into the United States. Each of these proposed mitigation measures is discussed below.
We are proposing to add the conditions for importing specified ruminant commodities from a BSE minimalrisk region to the regulations in 9 CFR parts 93, 94, and 95. The measures appropriate for specific commodities intended for importation would be determined by the presence or absence of factors that make it more or less likely the commodity might be contaminated or infected with the BSE. These factors are discussed in the following paragraphs.
Feed Source and Exposure
Oral ingestion of feed contaminated with the abnormal BSE prion
protein is the only documented route of field transmission of BSE.\3\
Thus, animals that have not ingested contaminated feed are unlikely to
harbor the agent, so feed exposure influences risk. Animals, and the
products derived from those animals, are unlikely to have infectious
levels of the agent and will present a lower risk if the animals were
(a) born after the implementation of an effective feed ban or (b) not
fed risk material (e.g., wild animals or farmed animals that are not fed feeds containing meatandbone meal).
\3\ Prince, M.J., et al.; 2003; Bovine Spongiform
Encephalopathy; Rev. sce. tech. OIE; 22 (1), pg 3760.
Wilesmith et al.; 1988; 1991; 1992.
The risks associated with feed source and exposure can be mitigated by accepting for import only animals or products derived from animals that have not been fed commercial feed that is likely to be contaminated with infectious levels of the agent.
Animal Age
Levels of infectious agent in certain tissues vary with the age of
an animal, so the age of the animal influences risk. Pathogenesis
studies, where tissues obtained from orally infected calves were
assayed for infectivity, have illustrated this.\4\ Infectivity was not
detected in most tissues until at least 32 months postexposure. The
exception to this is the distal ileum (a part of the intestines), where infectivity was
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confirmed from the experimentally infected cattle as early as 6 months
postexposure. In this proposed rule, we take these findings into
account when establishing measures to mitigate the risk of infectious
levels of the BSE agent being present in animals and animal products
imported from a BSE minimalrisk region. For example, with regard to
bovines, because BSE infectivity has not been found in most bovine
tissues until at least 32 months postexposure, we believe that by
requiring that bovines imported into the United States from BSE
minimalrisk regions be less than 30 months of age, the risk of the BSE
agent being present at infectious levels in most tissues in the animal
is minimized. The 30month age limit is accepted internationally in BSE
standards set by various countries and is consistent with OIE
recommendations. Similarly, the proposed regulations would require that
imported meat from bovines be derived from animals less than 30 months
of age when slaughtered. However, because of evidence that the BSE
agent may be present at infectious levels in the distal ileum of
infected bovines as early as 6 months postexposure, we would require
that the intestines of bovines imported into the United States be
removed at slaughter, and that meat imported from bovines from BSE
minimalrisk regions be derived from animals from which the intestines were removed at slaughter.
\4\ Wells, G.A.H., et al.; 1994; Infectivity in the ileum of
cattle challenged orally with bovine spongiform encephalopathy; Veterinary Record; 135 (2), pg 4041.
Wells, G.A.H., et al.; 1998; Preliminary observations on the pathogenesis of experimental bovine spongiform encephalopathy (BSE): An update; Veterinary Record; 142, pg 103106.
European Union Scientific Steering Committee (EU SSC), 2002; Update of the opinion on TSE infectivity distribution in ruminant tissues (initially adopted by the Scientific Steering Committee at its meeting of 1011 January 2002 and amended at its meeting of 78 November 2002) following the submission of (1) a risk assessment by the German Federal Ministry of Consumer Protection, Food, and Agriculture, and (2) new scientific evidence regarding BSE infectivity distribution in tonsils; European Commission, Scientific Steering Committee, Health and Consumer Protection Directorate General.
Although the risks associated with age can be mitigated by accepting for import only animals or commodities derived from animals of an age where even high risk tissues (discussed below) are unlikely to have infectious levels of the BSE agent, restrictions applicable to age alone may not always be possible or sufficient. For instance, in the case of wild cervids, because it is not always possible to determine the age of the cervids, we believe that alternative risk measures, discussed below, are necessary.
Research demonstrates that the incubation period for BSE is apparently linked to the infectious dose receivedi.e., the larger the infectious dose received, the shorter the incubation period (EU SSC 2002). While some cases of BSE have been found in animals less than 30 months of age, these are relatively few and have occurred primarily in countries with significant levels of circulating infectivity (i.e., where infected ruminants are used for feed for other ruminants, which in turn become infected). The conditions, discussed above, for qualifying for a BSE minimalrisk region guard against such circulating infectivity.
Similar observations regarding the importance of the size of the infectious dose were made in sheep and goats (EU SSC 2002). In these animals, infectivity could not be demonstrated in most tissues until at least 16 months postexposure to the agent.
In summary, infected cattle over 30 months of age or sheep and goats over 16 months of age may have levels of the abnormal prion in affected tissues that are sufficient to infect other animals fed protein derived from these tissues. Infected animals less than 30 months of age or sheep and goats less than 16 months of age are unlikely to have infectious levels of the prion protein (EU SSC 2002; Wells, et al.; 1994; Wells, et al.; 1998).
Animals that were born before the feed ban but were not fed risk material, such as wild ruminants or domestic livestock in the minimal risk region that were fed solely materials that are extremely unlikely to contain the infectious agent, are unlikely to contain infectious levels of BSE.
Tissue Localization
Some bovine tissues have demonstrated infectivity, whereas others
have not. Tissues that have demonstrated infectivity, and thus are
likely to contain the infectious agent in infected cattle, are brain,
tonsil, spinal cord, eyes, trigeminal ganglia, dorsal root ganglia, and
distal ileum. (Please note that, as discussed above, the age of an
animal is a key factor in whether the animal is likely or unlikely to
be infected. Cattle less than 30 months of age unlikely to be infected
with BSE, and, therefore, even the tissues listed above, except for the
distal ileum, from such animals are unlikely to contain the infectious
agent.) Affiliated tissues or structures such as skull or vertebral
column are considered risk materials because of the difficulty in
separating out small tissues such as dorsal root ganglia from the
vertebral column. Possibilities for cross contamination from risk
materials must be considered also. However, even cattle carrying the
infectious agent are unlikely to carry that agent in tissues that have
not demonstrated infectivity (e.g., muscle, liver, skin, hide, milk,
embryos) or products derived from these tissues \5\ (also, Wells, et al.; 1994; Wells, et al.; 1998).
\5\ Wrathall, A.E., et al.; 2002; Studies of embryo transfer
from cattle clinically affected by bovine spongiform encephalopathy (BSE); Veterinary Record; 150; pg 365378.
The risks associated with tissue localization can be mitigated by accepting only tissues that are unlikely to have infectious levels of the agent, due to the nature of the tissue or the age of the animal (in cattle under 30 months of age, only the distal ileum is such a risk material), or commodities derived from those tissues.
Source Species
Tissue distribution of the agent varies with species. Results from
experimental infections of sheep have shown that the BSE prion is
distributed more widely in sheep tissues than in cattle.\6\ This
distribution is similar to the distribution of scrapie (a transmissible
spongiform encephalopathy present in the United States) infections in sheep. In these infections, the agent may be found in the
lymphoreticular system and in peripheral nerves (Foster et al.; 1996; Foster et al.; 2001).
\6\ Foster, J.D., et al.; 1996; Detection of BSE infectivity in
brain and spleen of experimentally infected sheep; Veterinary Record; 139; pg 912915.
Foster, J.D., et al.; 2001; Distribution of the prion protein in sheep terminally affected with BSE following experimental oral transmission; J. Gen Virol.; 82; pg 23192326.
However, no natural infections with BSE have yet been confirmed in sheep, although testing is ongoing in Europe. Similarly, no natural infections have been confirmed in goats, although actual experiments have not been conducted in the species. In the absence of actual data, distribution of the agent in goat tissues has been assumed to be similar to distribution of the agent in sheep tissues, based on the fact that scrapie acts very similarly in sheep and goats.
Similarly, natural infection of cervids (deer and elk species) with BSE has not been documented, and no challenge studies on cervid susceptibility to BSE have been conducted. In the absence of actual data, it is assumed that distribution of any BSE agent in cervid tissues would be similar to the distribution of the chronic wasting disease agent in cervid tissues, which is a naturally occurring transmissible spongiform encephalopathy.
Prevalence of BSE
The possible prevalence of disease in the region of origin will
influence the risk. Prevalence of the disease will be lower in a
country with adequate prevention and control measures; thus, animals
from such a region will be at lower risk of being exposed to infection.
The risks associated with prevalence can be mitigated by accepting
commodities only from a country with low prevalence that can be classified as minimal or low risk.
[[Page 62392]]
Importation of Live Ruminants
We believe the categories of ruminants discussed below from BSE minimalrisk regions are unlikely to be a source of infectivity of the BSE agent if the conditions specified below are met, and we propose to allow for such importation under those conditions in a new Sec. 93.436. In each case where we are proposing to allow importation, the animals would have to arrive through a designated port of entry as listed in current Sec. 93.403(b) (designated ports of entry for ruminants from Canada), or through some other port that has been designated as a port of entry by the Administrator under Sec. 93.403(f). If, in the future, we add other countries to the list of BSE minimalrisk regions in Sec. 94.18(a)(3), we would adjust the list of designated ports accordingly.
In those cases where a ruminant is imported into the United States, and subsequently does not meet one of the conditions set forth in Sec. 93.436 (e.g., animals that die before reaching the slaughtering establishment; animals that are moved from a feedlot in this country to slaughter after they are 30 months of age), the regulations would provide that the animal must be disposed of in a manner approved by the Administrator.
Bovines Less Than 30 Months of Age for Immediate Slaughter
Section 93.436, paragraph (a), would allow the importation of
bovines for immediate slaughter under the following conditions:
[sbull] The bovines are less than 30 months of age and are moved
directly as a group from the port of entry to a recognized slaughtering
establishment (the definition of recognized slaughtering establishment
is set forth in Sec. 93.400) for immediate slaughter as a group.
(Under the definition of immediate slaughter in Sec. 93.400, the
bovines must be slaughtered within 2 weeks of the date of entry. In
Sec. 93.400, we would add a definition of as a group to mean
collectively, in such a manner that the identity of the animals as a unique group is maintained.)
[sbull] The bovines are not known to have been fed ruminant protein, other than milk protein, during their lifetime.
[sbull] The bovines are accompanied by a certificate issued by a
fulltime salaried veterinary officer of the national government of the
region of origin, or issued by a veterinarian designated or accredited
by the national government of the region of origin and endorsed by a
fulltime salaried veterinary officer of the national government of the
region of origin, representing that the veterinarian issuing the
certificate was authorized to do so, that certifies the above conditions have been met.
[sbull] The bovines are moved as a group from the port of entry to
the slaughtering establishment in conveyances sealed at the port of
entry with seals of the United States Government, which are broken only
at the slaughtering establishment by a USDA representative, and the
shipment is accompanied by an APHIS Veterinary Services (VS) Form 17 33, Animals Imported for Immediate Slaughter.
[sbull] At the slaughtering establishment, the bovines are
slaughtered as a group and each animal's intestines are removed.
[sbull] The intestines removed from the bovines are disposed of in a manner approved by the Administrator.
We believe the conditions described above, combined with the fact
the exporting region is one of minimal risk for BSE, make it very
unlikely that meat derived from bovines meeting those conditions would
contain the BSE agent. The requirement that the bovines imported from a
BSE minimalrisk region be less than 30 months of age would make it
unlikely they would have infectious levels of the prion protein. The
requirements that the bovines be moved to slaughter in a sealed
conveyance and be slaughtered as a group are designed to ensure that
the animals are not diverted while being moved to slaughter and that
the intestines are removed at slaughter from all bovines imported from
the minimalrisk region. If any bovines not from the minimalrisk
region are commingled with the group of bovines from the minimalrisk
region at the slaughtering establishment, then those added animals
would be treated as if they were from the minimalrisk region and their
intestines would have to be removed and disposed of in accordance with
our proposed provisions. The requirement that the bovines be
slaughtered at a recognized slaughtering establishment (as defined in
Sec. 93.400) would ensure the animals are slaughtered at a facility
approved by APHIS where slaughtering operations are regularly carried
on under Federal or State inspection. The requirement that the
intestines be removed from the animal at slaughter and be disposed of
in a manner approved by the Administrator would minimize the
possibility that such materials will be fed to ruminants. We believe it
is necessary to provide the Administrator discretion in the specific
means of disposal used, to allow for the use of different but equally effective methods of disposal.
Bovines Less Than 30 Months of Age Moved to a Designated Feedlot and Then to Slaughter
We would apply the slaughtering conditions described above to bovines imported for slaughter in the United States after first being contained at a designated feedlot in this country. However, instead of being moved directly from the port of entry to a recognized slaughtering establishment, such animals would first be moved directly, as a group, to a designated feedlot for feeding, and then directly to a recognized slaughtering establishment. In Sec. 93.400, we would define designated feedlot to mean a feedlot indicated on the declaration required under Sec. 93.407 as the destination of the ruminants imported into the United States. Under current Sec. 93.407, the importer of ruminants (or the importer's agent) must present a declaration at the port of entry that provides information about the ruminants, their origin, and their destination. For identification purposes, prior to being imported into the United States, each bovine would have to have been tattooed inside one ear with letters identifying the exporting country. Bovines from Canada would have to be tattooed with the letters ``CAN.''
Therefore, Sec. 93.436(b) would allow the importation of bovines for feeding under the following conditions:
[sbull] The bovines are not known to have been fed ruminant
protein, other than milk protein, during their lifetime and are less
than 30 months of age when imported into the United States.
[sbull] The inside of one ear on each animal is permanently and
legibly tattooed with letters identifying the exporting country.
[sbull] The bovines are accompanied by authorized official
certification, as described above, that the above conditions have been met.
[sbull] The bovines are moved directly from the port of entry as a
group to the designated feedlot and the shipment is accompanied by an
APHIS Form VS 127, Permit for Movement of Restricted Animals.
[sbull] The bovines are moved directly from the designated feedlot
to a recognized slaughtering establishment for slaughter, where each
animal's intestines are removed. The shipment is accompanied by APHIS Form VS 127.
[sbull] The intestines removed from the bovines are disposed of in a manner approved by the Administrator.
[sbull] The bovines are less than 30 months of age when slaughtered.
Unlike the requirement for bovines moved directly to immediate slaughter, we would not require that the animals
[[Page 62393]]
be moved from the port of entry to the designated feedlot in sealed
conveyances. The only region we are proposing at this time to classify
as BSE minimalrisk is the country of Canada. Under the current APHIS
regulations and policy, bovines imported from Canada for movement
directly to immediate slaughter do not have to be accompanied by the
health certificate required under Sec. 93.405 that attests to the
animal's health history with regard to various diseases and pests.
However, the bovines must be moved to slaughter in a sealed conveyance.
(Please note: The regulations in part 93 use the term ``cattle'' rather
than ``bovines.'' However, in Sec. 93.400, cattle is defined as
animals of the bovine species.) Because of the requirement for direct
movement to slaughter in a sealed conveyance, there is little danger
the bovines will be diverted on their way to the slaughtering
establishment. Those requirements would remain unchanged by this
proposed rule, although animals for immediate slaughter would have to
be accompanied with the certification with regard to BSE specified in this proposal.
Under the current regulations, however, bovines imported from Canada for other than immediate slaughter do have to be accompanied by a certificate attesting to their health history with regard to various diseases, in order to ensure they do not spread such diseases to other livestock in this country. Because of their acceptable health history, it has not been necessary to require that the animals be moved in a sealed conveyance. This requirement for a health certificate would remain in place for bovines imported from Canada for feeding before slaughter (and be joined with the certification with regard to BSE specified in this proposal). Because of this health certification, and because, with regard to BSE, the bovines would have to be tattooed with the letters CAN, possible diversion is not an issue and we do not consider it necessary to begin to require that feeder bovines be moved from the U.S. port of entry to the designated feedlot in a sealed conveyance.
Additionally, we are not requiring that the bovines be moved from the designated feedlot to slaughter as a group. A shipment of bovines that arrives at a feedlot may contain animals of varying ages. Some will be ready for shipment to slaughter before others. However, we would require that all animals moved from the designated feedlot be moved directly to slaughter, where they would be identifiable as a shipment from a minimalrisk region by the required ear tattoo. Sheep or Goats Less Than 12 Months of Age for Immediate Slaughter
Section 93.436, paragraph (c), would allow the importation of sheep or goats under the following conditions:
[sbull] The sheep or goats are less than 12 months of age at the time of importation.
[sbull] The sheep or goats are not known to have been fed ruminant protein, other than milk protein, during their lifetime.
[sbull] The sheep or goats are accompanied by authorized official
certification, as described above, that the above conditions have been met.
[sbull] The sheep or goats are moved directly from the port of
entry as a group to a recognized slaughtering establishment in
conveyances sealed at the port of entry with seals of the United States
Government, which are broken only at the slaughtering establishment by
a USDA representative, and must be slaughtered as a group. The shipment is accompanied by an APHIS Form VS 1733.
Although there is no naturally occurring BSE infection of sheep and goats, the species can be infected with the BSE agent experimentally. However, in view of the relatively young age of the sheep and goats that would be allowed importation (we would allow importation of sheep and goats only of 12 months of age or less, the industry standard for commercial shipments of such animals), the likelihood that these sheep or goats could provide a source of infection is extremely low. Sheep or Goats Less Than 12 Months of Age Moved to a Designated Feedlot and Then To Slaughter
We would apply the slaughtering conditions described above to sheep or goats imported for slaughter in the United States after first being contained at a designated feedlot in this country. However, instead of being moved directly from the port of entry to a recognized slaughtering establishment, such animals would be moved to a designated feedlot, and then directly to a recognized slaughtering establishment. For identification purposes, prior to being imported into the United States, each sheep and goat would have to have been tattooed inside one ear with letters identifying the exporting country. Sheep and goats from Canada would have to be tattooed with the letters ``CAN.''
Therefore, Sec. 93.436(d) would allow the importation of sheep and goats under the following conditions:
[sbull] The sheep and goats are not known to have been fed ruminant
protein, other than milk protein, during their lifetime and are less
than 12 months of age at the time of importation into the United States.
[sbull] The inside of one ear on each animal is permanently and
legibly tattooed with letters identifying the exporting country.
[sbull] The sheep or goats are accompanied by authorized official
certification, as described above, that the above conditions have been met.
[sbull] The sheep or goats are moved directly from the port of
entry as a group to a designated feedlot and the shipment is accompanied by an APHIS Form VS 127.
[sbull] The sheep or goats are moved directly from the designated
feedlot to a recognized slaughtering establishment for slaughter. The shipment is accompanied by APHIS Form VS 127.
[sbull] The sheep and goats are less than 12 months of age when slaughtered.
Cervids for Immediate Slaughter
Section 93.436, paragraph (e), would allow the importation of cervids under the following conditions:
[sbull] The cervids were members of a herd in which surveillance
for transmissible spongiform encephalopathies (TSE's) was conducted by
appropriate authorities according to national standards or standards of
the region itself if the region is a jurisdiction that has effective
oversight of normal animal movements into, out of, or within the region
and that, in association with national authorities if necessary, has the responsibility for controlling animal disease locally.
[sbull] The herd is not known to have been infected with or exposed to a TSE.
[sbull] The cervids were born after the implementation of a ban on feeding of ruminant protein to ruminants.
[sbull] The cervids were not known to have been fed ruminant protein, other than milk protein, during their lifetime.
[sbull] The cervids are accompanied by authorized official
certification, as described above, that the above conditions have been met.
[sbull] The cervids are moved from the port of entry as a group
directly to a recognized slaughtering establishment in conveyances
sealed at the port of entry with seals of the United States Government,
which are broken only at the slaughtering establishment by a USDA
representative. The cervids must be slaughtered as a group. The shipment is accompanied by an APHIS Form VS 1733.
As ruminants, cervids are subject to import restrictions because of
BSE. We believe that the above conditions are necessary for the
importation of cervids intended for immediate slaughter, because, although there have been no
[[Page 62394]]
confirmed cases of BSE in cervids, it is possible that they are
susceptible to BSE. To date, there have been no challenge studies for
BSE in cervids (i.e., studies in which cervids are intentionally
exposed to the BSE agent) to indicate the level of susceptibility of
cervids to BSE. Given the stringent controls described above, however,
and the fact that there have been no confirmed cases of BSE in cervids,
we believe the likelihood BSE would be introduced into the United
States through cervid importations is extremely low, and we do not
believe that mitigation measures other than those listed above are necessary.
One of the requirements listed above is that the cervids have been members of a herd in which surveillance for TSE's was conducted by appropriate authorities according to national or regional standards. At present, the TSE program for cervids in Canada, the one region we are proposing to classify as BSEminimal risk at this time, is one that monitors for chronic wasting disease (CWD). However, all sampling done to monitor for CWD would identify animals that might be affected with other TSE's such as BSE.
Ruminant Products From MinimalRisk Regions
We are proposing to add a new Sec. 94.19 to list those ruminant products that would be allowed importation from a BSE minimalrisk region and to set forth the conditions for such importation.
In evaluating the risk that ruminant products imported into the United States might present, the same factors affecting the BSE risk of the live animals from which the products are derived are applicable. Additionally, other factors must be considered due to the processing the products undergo. Slaughter methods and the removal of risk material from source animals in the exporting region affect the level of risk associated with meat and meat products from those animals, as do intended use and the demonstrated likelihood of the animal product in question to contain the BSE agent.
Similar to the slaughter requirements for ruminants imported live into the United States for immediate slaughter, it would be necessary to require that most ruminant products intended for importation into the United States from a BSE minimalrisk region come from animals from which intestines were removed during processing. In some cases, however, because of other mitigating factors, such as if no natural infection has been observed in the type of animal, we do not believe it would be necessary to require that the intestines have been removed from the animal from which the product is derived.
We believe that the importation of the categories of meat and other edible products from ruminants from BSE minimalrisk regions discussed below would be unlikely to contain the BSE agent provided the following conditions are met, as certified to on an original certificate issued by a fulltime salaried veterinary officer of the national government of the region of origin, or issued by a veterinarian designated or accredited by the national government of the region of origin and endorsed by a fulltime salaried veterinary officer of the national government of the region of origin, representing that the veterinarian issuing the certificate was authorized to do so.
As one of the conditions for bringing the commodity into the United States, we are proposing that the meat and edible products, if arriving at a land border port, arrive only at one of the ports we would list in new Sec. 94.19(k). At this time, the only region that would be listed in Sec. 94.18(a)(3) as a BSE minimalrisk region would be the country of Canada. Because the type of shipments that would require inspection under this proposed rule have not been subject to inspection in recent years when arriving at land border ports from Canada, we believe it is advisable to limit their arrival by land from Canada to those U.S. ports staffed with personnel fully trained in the inspection of such shipments.
We would list the following as designated land border ports in Sec. 94.19(k): Eastport, ID; Houlton, ME; Detroit (Ambassador Bridge), Port Huron, and Sault St. Marie, MI; International Falls, MN; Sweetgrass, MT; Alexandria Bay, Buffalo (Lewiston Bridge and Peace Bridge), and Champlain, NY; Pembina and Portal, ND; Derby Line and Highgate Springs, VT; and Blaine (Pacific Highway and Cargo Ops), Lynden, Oroville, and Sumas (Cargo), WA. If, in the future, we add other countries to the list of BSE minimalrisk regions in Sec. 94.18(a)(3), we would adjust the list of designated ports accordingly. Fresh (Chilled or Frozen) Meat From Bovines Less Than 30 Months of Age
Section 94.19, paragraph (a), would allow the importation of meat under the following conditions:
[sbull] The meat is fresh (chilled or frozen) meat from bovines
less than 30 months old at the time of slaughter that are not known to
have been fed ruminant protein, other than milk protein, during their lifetime.
[sbull] The bovines from which the meat is derived were slaughtered
in a slaughtering establishment that slaughters only bovines less than
30 months of age or complies with a segregation process approved by the
national veterinary authority of the region of origin and the
Administrator as adequate to prevent contamination or commingling of
the meat with products not eligible for importation into the United States.
[sbull] The intestines of the bovines were removed at slaughter.
[sbull] The product qualifies as meat according to the definition
of meat set forth in USDA's Food Safety and Inspection Service's (FSIS) regulations at 9 CFR 301.2.
[sbull] The shipment is accompanied by authorized official
certification, as described above, that the above conditions have been met.
We would require that the commodity meet the definition of ``meat'' according to the FSIS regulations to ensure that, if imported as ground meat, it has not been combined with meat that might contain highrisk tissues from highrisk animals. Under the FSIS definition in 9 CFR 301.2, to be considered ``meat,'' product that undergoes mechanical separation and meat recovery from the bones of livestock must be processed in such a way that the processing does not crush, grind, or pulverize bones, so that bones emerge comparable to those resulting from handdeboning and the meat itself meets the criteria of no more than 0.15 percent or 150 mg/100 gm of product for calcium (as a measure of bone solids content) within a tolerance of 0.03 percent or 30 mg. We are proposing to use this standard for the eligibility of meat from bovines (and, as indicated later, for meat from sheep and goats) to ensure that the product contains no mechanically separated meat that might contain high risktissues. (Please note: Except where the FSIS definition of meat is specifically referenced in proposed Sec. 94.19(a)(3) with regard to meat from bovines, and in proposed Sec. 94.19(e)(2) with regard to meat from sheep or goats or other ovines or caprines, the standard dictionary definition of meat is intended throughout this proposed rule.)
To avoid commingling or contamination of meat from bovines under 30
months of age with materials from older bovines, we would require that
the slaughtering facility in the region of origin either slaughter only
bovines less than 30 months of age or comply with an approved segregation process. Such segregation during
[[Page 62395]]
slaughtering could be accomplished, for instance, by slaughtering
bovines over 30 months of age only at the end of the day on lines and
with equipment dedicated exclusively to slaughtering such older animals.
Fresh (Chilled or Frozen) Whole or Half Carcasses of Bovines Less Than 30 Months of Age
Section 94.19, paragraph (b), would allow the importation of bovine carcasses under the following conditions:
[sbull] The products are fresh (chilled or frozen) whole or half
carcasses derived from bovines that were less than 30 months of age
when slaughtered and that are not known to have been fed ruminant protein, other than milk protein, during their lifetime.
[sbull] The bovines from which the carcasses are derived were
slaughtered in a slaughtering establishment that slaughters only
bovines less than 30 months of age or complies with a segregation
process approved by the national veterinary authority of the region of
origin and the Administrator as adequate to prevent contamination or
commingling with products not eligible for importation into the United States.
[sbull] The intestines of the bovines were removed at slaughter.
[sbull] The shipment is accompanied by authorized official certification that the above conditions have been met.
Fresh (Chilled or Frozen) Bovine Liver
Section 94.19, paragraph (c), would allow the importation of fresh (chilled or frozen) bovine liver, provided the product is combined with no other product, is derived from bovines
FOR FURTHER INFORMATION CONTACT
Dr. Karen James-Preston, Director, Technical Trade Services, National Center for Import and Export, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 207371231; (301) 734 4356.