Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation of Commodities, 460-553 [04-28593]

Agencies

• DEPARTMENT OF AGRICULTURE
• Animal and Plant Health Inspection Service

[Federal Register Volume 70, Number 2 (Tuesday, January 4, 2005)]
[Rules and Regulations]
[Pages 460-553]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 04-28593]



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Part III





Department of Agriculture





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Animal and Plant Health Inspection Service



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9 CFR Parts 93, 94, 95, and 96



Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation 
of Commodities; Final Rule and Notice

Federal Register / Vol. 70, No. 2 / Tuesday, January 4, 2005 / Rules 
and Regulations

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 93, 94, 95, and 96

[Docket No. 03-080-3]
RIN 0579-AB73


Bovine Spongiform Encephalopathy; Minimal-Risk Regions and 
Importation of Commodities

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending the regulations regarding the importation of 
animals and animal products to establish 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 byproducts, and we are adding Canada to this category. We are also 
establishing conditions for the importation of certain live ruminants 
and ruminant products and byproducts from such regions. These actions 
will continue to protect against the introduction of BSE into the 
United States while removing unnecessary prohibitions on the 
importation of certain commodities from minimal-risk regions for BSE, 
currently only Canada.

EFFECTIVE DATE: March 7, 2005.

FOR FURTHER INFORMATION CONTACT: For information concerning ruminant 
products, contact Dr. Karen James-Preston, Director, Technical Trade 
Services, National Center for Import and Export, VS, APHIS, 4700 River 
Road Unit 38, Riverdale, MD 20737-1231; (301) 734-4356.
    For information concerning live ruminants, contact Lee Ann Thomas, 
Director, Technical Trade Services, Animals, Organisms and Vectors, and 
Select Agents, National Center for Import and Export, VS, APHIS, 4700 
River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-4356.
    For other information concerning this rule, contact Dr. Gary 
Colgrove, Director, Sanitary Trade Issues Team, National Center for 
Import and Export, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 
20737-1231; (301) 734-4356.

SUPPLEMENTARY INFORMATION:

I. Purpose

    This document makes final, with changes, a proposed rule that the 
Animal and Plant Health Inspection Service (APHIS) of the U.S. 
Department of Agriculture (USDA or the Department) published in the 
Federal Register on November 4, 2003 (68 FR 62386-62405, Docket No. 03-
080-1). In that document, we proposed to establish 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 byproducts, and to add Canada to this category. 
The proposal also set forth conditions for the importation of certain 
live ruminants and ruminant products and byproducts from BSE minimal-
risk regions. We solicited public comment on the proposed rule and its 
underlying risk analysis and other supporting analyses for 60 days 
ending on January 5, 2004. At the time the proposed rule was published, 
BSE had never been detected in a native animal in the United States and 
only a single case in a native animal had been reported in Canada (in 
Alberta in May 2003). In December 2003, BSE was detected in an imported 
dairy cow in Washington State. This document describes the course of 
this rulemaking before and after the detection in Washington State, 
including how the rulemaking was affected by additional BSE-related 
safeguards imposed by USDA's Food Safety and Inspection Service (FSIS) 
in January 2004. It also responds to public comments received on the 
proposed rule and its underlying risk analysis and other supporting 
analyses, both before the original closing date on January 5, 2004, and 
during an extended comment period that closed on April 7, 2004, and 
explains the changes we are making in this final rule.

II. Summary of Changes Made in This Final Rule

    Based on our continued analysis of the issues and on information 
provided by commenters, we have made certain changes in this final rule 
from the provisions we proposed in November 2003, as supplemented by 
our March 2003 notice of the extension of the comment period. Those 
changes, summarized in the list below, are discussed in detail in our 
responses to comments.
    1. For bovines imported from a BSE minimal-risk region for feeding 
and then slaughter (referred to as feeder cattle), we are making the 
following changes:
     We are requiring that feeder cattle be permanently marked 
before entry as to country of origin with a brand or other means of 
identification approved by the Administrator, rather than by an ear 
tattoo as proposed. Feeder cattle imported from Canada must be marked 
with ``C[and]N.''
     We are requiring that feeder cattle be individually 
identified before entry by an eartag that allows the animal to be 
traced back to the premises of origin and are specifying that the 
eartag may not be removed until the animal is slaughtered.
     We are requiring that the animal health certification 
currently required under existing Sec.  93.405 for certain live animals 
imported into the United States include, for feeder cattle imported 
from a BSE minimal-risk region, additional information relating to 
animal identification, origin, destination, and responsible parties.
     We are requiring that feeder cattle be moved from the port 
of entry to a feedlot in a sealed means of conveyance and then from the 
feedlot to a recognized slaughtering establishment in a sealed means of 
conveyance. The cattle may not be moved to more than one feedlot.
     When referring to the destination of feeder cattle 
imported into the United States, we are using the terminology ``the 
feedlot identified on the APHIS Form VS 17-130'' rather than 
``designated feedlot.''
     We are specifying that the physical location of the 
feedlot of destination and the person responsible for movement of the 
cattle be identified on the documentation required for movement from 
the port of entry to the feedlot.
    2. For sheep and goats imported from a BSE minimal-risk region for 
feeding and then slaughter (referred to as ``feeder sheep and goats'') 
we are making the following changes:
     As with cattle, we are requiring that feeder sheep and 
goats be permanently marked before entry as to country of origin (with 
the requirements for marking modified as appropriate for sheep and 
goats). Feeder sheep and goats imported from Canada must be marked with 
``C.''
     As with cattle, we are requiring that feeder sheep and 
goats be individually identified before entry by an eartag that allows 
the animal to be traced back to the premises of origin and are 
specifying that the eartag may not be removed until the animal is 
slaughtered.
     We are continuing to refer to the feedlot of destination 
for feeder sheep and goats as a ``designated feedlot'' and are adding 
criteria for such feedlots. The sheep and goats may not be moved to 
more than one designated feedlot.
     We are requiring the same additional information on the 
health certification required under Sec.  93.405 as described above for 
feeder cattle.
     We are requiring that feeder sheep and goats be moved from 
the port of entry to a designated feedlot as a group in a sealed means 
of conveyance, not be

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commingled with any sheep or goats that are not being moved directly to 
slaughter from the designated feedlot at less than 12 months of age, 
and be moved from the designated feedlot to a recognized slaughtering 
establishment in a sealed means of conveyance.
    3. For sheep and goats imported from a BSE minimal-risk region for 
immediate slaughter, we are prohibiting the importation of sheep and 
goats that are positive, suspect, or susceptible for TSEs.
    4. We are moving the provisions for the importation of feeder sheep 
and goats from Canada from proposed Sec.  93.436 to Sec.  93.405 and 
Sec.  93.419.
    5. We are moving the provisions for the importation of sheep and 
goats from Canada for immediate slaughter from proposed Sec.  93.436 to 
Sec.  93.419 and Sec.  93.420.
    6. We are clarifying in Sec.  93.420 that all ruminants imported 
from Canada for immediate slaughter must be moved to a recognized 
slaughtering establishment in a sealed means of conveyance.
    7. We are not specifying in our regulations that the intestines 
from bovines imported from Canada be removed at slaughter in the United 
States and be disposed of in a manner approved by the Administrator.
    8. We are not including any import restrictions because of BSE for 
live cervids (e.g., deer, elk) and cervid products from a BSE minimal-
risk region.
    9. We are specifying that there are no import restrictions because 
of BSE for camelids (i.e., llamas, alpacas, guanacos, and vicunas) from 
a BSE minimal-risk region.
    10. We are also providing in Sec.  94.18 for the overland 
transiting of products derived from bovines, sheep, and goats from a 
BSE minimal-risk region that are eligible for entry into the United 
States. Additionally, we are clarifying that the existing provisions in 
Sec.  94.18 for the transiting of ruminant products from regions in 
which BSE exists or that pose an undue risk of BSE apply only to 
transiting at air or sea ports.
    11. We are requiring that bovines, sheep, and goats imported from a 
BSE minimal-risk region be subject to a ruminant feed ban equivalent to 
requirements established by Food and Drug Administration (FDA) of the 
U.S. Department of Health and Human Services at 21 CFR 589.2000. This 
is a change from our proposal that the ruminants ``are not known to 
have been fed ruminant protein, other than milk protein.''
    12. In the definition of bovine spongiform encephalopathy (BSE) 
minimal-risk region, we are rewording the factor that said a BSE 
minimal-risk region is one that has ``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'' to say instead that the region 
is one in which ``a ruminant-to-ruminant feed ban is in place and is 
effectively enforced.''
    13. We are providing that meat, meat byproducts, and meat food 
products derived from bovines from a BSE minimal-risk region may not be 
imported into the United States unless an air-injected stunning process 
was not used at slaughter and unless the specified risk materials 
(SRMs) and the small intestine were removed in the exporting region, 
consistent with the FSIS regulations at 9 CFR 313.15 and 310.22 for 
stunning and processing in the United States. We are defining SRMs as 
those materials designated as such by FSIS in 9 CFR 310.22, to include 
the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral 
column (excluding the vertebrae of the tail, the transverse process of 
the thoracic and lumbar vertebrae, and the wings of the sacrum), and 
dorsal root ganglia of cattle 30 months of age and older, and the 
tonsils and distal ileum of the small intestine of all cattle.
    14. We are removing the proposed requirement that imported meat 
derived from bovines from BSE minimal-risk regions be derived only from 
animals less than 30 months of age when slaughtered.
    15. We are removing the proposed requirement that meat derived from 
bovines in a BSE minimal-risk region that are slaughtered in that 
region come from animals slaughtered at a facility that either 
slaughters only bovines less than 30 months of age or complies with an 
approved segregation process.
    16. We are clarifying that the final rule applies to ``meat,'' 
``meat byproducts,'' and ``meat food products'' as defined by FSIS.
    17. We are removing the requirement that hunter-harvested meat be 
accompanied by a certificate of the national government of Canada.
    18. We are clarifying the type of ruminant offal from a BSE 
minimal-risk region that is allowed importation into the United States.
    19. We are providing that tallow may be imported from a BSE 
minimal-risk region provided the tallow is composed of less than 0.15 
percent insoluble impurities and is not commingled with any other 
material of animal origin.
    20. We are providing that, except for gelatin allowed importation 
under Sec.  94.18(c), gelatin imported from a BSE minimal-risk region 
must be derived from the bones of bovines that were subject to a 
ruminant feed ban equivalent to the requirements established by FDA at 
21 CFR 589.2000 and from which SRMs were removed.
    21. We are providing that sheep casings may be imported from a BSE 
minimal-risk region provided the sheep from which the casings were 
derived were less than 12 months of age when slaughtered and were 
subject to a ruminant feed ban equivalent to that of FDA at 21 CFR 
589.2000.
    22. We are adding and revising definitions in this final rule to 
clarify the meaning of certain terms used in the rule.

III. Background

A. Bovine Spongiform Encephalopathy

    APHIS regulates the importation of animals and animal products into 
the United States to guard against the introduction of various animal 
diseases, including BSE. The regulations are contained in 9 CFR parts 
92, 93, 94, 95, and 96.
    BSE is a progressive and fatal neurological disorder of cattle that 
results from an unconventional transmissible agent. BSE belongs to the 
family of diseases known as transmissible spongiform encephalopathies 
(TSEs). In addition to BSE, TSEs include, among other diseases, scrapie 
in sheep and goats, chronic wasting disease (CWD) in deer and elk, and 
variant Creutzfeldt-Jakob disease in humans. The agent that causes BSE 
and other TSEs has yet to be fully characterized. The theory that is 
most accepted in the scientific community is that the agent is a prion, 
which is an abnormal form of a normal protein known as cellular prion 
protein. The BSE agent does not evoke any demonstrated immune response 
or inflammatory reaction in host animals. BSE is confirmed by 
postmortem microscopic examination of an animal's brain tissue or by 
detection of the abnormal form of the prion protein in an animal's 
brain tissues. 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. 
BSE is spread to cattle primarily through the consumption of animal 
feed containing protein from ruminants infected with BSE.
    BSE was first diagnosed in 1986 in the United Kingdom. Since then, 
there have been more than 187,000 confirmed cases of BSE in cattle 
worldwide. The disease

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has been confirmed in native-born cattle in 20 European countries in 
addition to the United Kingdom, and in some non-European countries, 
including Japan, Israel, and Canada. Over 95 percent of all BSE cases 
have occurred in the United Kingdom, where the epidemic peaked in 1992/
1993. Agricultural officials in the United Kingdom have taken a series 
of actions to mitigate BSE, including making it a reportable disease, 
banning mammalian meat-and-bone meal in feed for all food-producing 
animals, prohibiting the inclusion of animals more than 30 months of 
age in the animal and human food chains, and destroying all animals 
showing signs of BSE and other potentially exposed animals at high risk 
of developing the disease. As a result of these actions, most notably 
the feed bans, the annual incidence of BSE in the United Kingdom has 
fallen dramatically. The figure below illustrates the downward trend in 
BSE cases among cattle born after implementation of the feed ban.
[GRAPHIC] [TIFF OMITTED] TR04JA05.010

    Variant Creutzfeld-Jakob disease (vCJD), a chronic and fatal 
neurodegenerative disease of humans, has been linked via scientific and 
epidemiological studies to exposure to the BSE agent, most likely 
through consumption of cattle products contaminated with the BSE agent. 
To date, since vCJD was first identified in 1996, approximately 150 
probable and confirmed cases of vCJD have been identified. The majority 
of these cases have either been identified in the United Kingdom or 
were linked to exposure that occurred in the United Kingdom, and all 
cases have been linked to exposure in countries with native cases of 
BSE. Some studies estimate that more than 1 million cattle may have 
been infected with BSE throughout the epidemic in the United Kingdom. 
This number of infected cattle could have introduced a significant 
amount of infectivity into the human food supply. Yet, the number of 
cases of vCJD identified to date suggest a substantial species barrier 
that may protect humans from widespread illness due to BSE.

B. APHIS' Regulatory Approach to BSE: Past and Present

    Since 1989 APHIS has prohibited the importation of live cattle and 
other ruminants and certain ruminant products, including most rendered 
protein products, into the United States from countries where BSE is 
known to exist. In 1997, due to concerns about widespread risk factors 
and inadequate surveillance for BSE in many European countries, APHIS 
added an additional classification of countries as regions of undue 
risk for BSE and extended importation restrictions on ruminants and 
ruminant products to all of the countries in Europe. In December 2000, 
APHIS expanded its prohibitions on imports of rendered ruminant protein 
products from BSE-restricted regions to include rendered protein 
products of any animal species, due to concern that cattle feed 
supposedly free of ruminant protein may have been cross-contaminated 
with the BSE agent. The same importation restrictions apply to regions 
where BSE has been confirmed in a native animal and regions that 
present an undue risk of BSE because of import requirements less 
restrictive than those that would be acceptable for import into the 
United States and/or because of inadequate surveillance (9 CFR 94.18).
    In effect then, until implementation of this final rule, countries 
have fallen into one of three categories with regard to BSE:
     Regions in which BSE is known to exist;
     Regions that present an undue risk of BSE because of 
import requirements less restrictive than those that would be 
acceptable for import into the United States and/or because of 
inadequate surveillance; and
     Regions that do not fall into either of the above two 
categories.
    This regulatory framework recognized only two risk situations--
those regions considered free of BSE and those regions considered to 
present a BSE risk--and prohibited the importation of live ruminants 
and most ruminant products from those regions considered to present a 
BSE risk.
    In our November 2003 proposed rule, we explained that we believed 
it was appropriate to establish an additional category of regions with 
regard to BSE--the BSE minimal-risk region. We stated that regions that 
could be eligible for a minimal-risk classification would be (1) those 
regions in which a BSE-infected animal has been diagnosed, but in which 
measures have been taken that make it unlikely that BSE would be 
introduced from that 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

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considered minimal risk. We proposed to add Canada to the new BSE 
minimal-risk category and also proposed conditions for the importation 
of certain live ruminants and ruminant products and byproducts from BSE 
minimal-risk regions.
    Our proposed definition of BSE minimal-risk regions included the 
standards we would use to evaluate the BSE risk from a region and to 
classify a region as one of minimal risk for BSE. To qualify as a BSE 
minimal-risk region, we proposed that a region be one that meets the 
following standards:
    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. Such measures include the following:
     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;
     Surveillance for BSE at levels that meet or exceed 
recommendations of the Office International des Epizooties (OIE, also 
now referred to as the World Organisation for Animal Health) for 
surveillance for BSE; and
     A ban on the feeding of ruminant protein to ruminants that 
appears to be an effective barrier to the dissemination of the BSE 
agent, with no evidence of significant noncompliance with the ban.
    2. In regions where BSE was detected, the region 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, 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.
    We stated in our proposal that we would use these standards as a 
combined and integrated evaluation tool, basing a BSE minimal-risk 
classification on the overall effectiveness of control mechanisms in 
place (e.g., surveillance, import controls, and a ban on the feeding of 
ruminant protein to ruminants). We noted that this approach would 
differ from some of the numerical guidelines specified by OIE in its 
recommendations for a BSE minimal-risk country or zone (discussed 
below).
Basis for Focused Regulatory Restrictions
    Our proposed rule was based on a number of considerations. A 
significant amount of research has been conducted on BSE since the 
disease was initially identified and since we first established our 
regulatory framework to protect against the introduction of BSE. 
(Please note: In this final rule, we use the term ``importation'' to 
mean the movement of animals or products into the United States or 
another country and the term ``introduction'' to mean the movement of a 
disease agent into the United States or another country.)
    While there are many unanswered questions, both research studies 
and field epidemiological experience have demonstrated effective 
control measures to prevent spread of this disease. Ongoing studies 
have identified specific tissues where the majority of infectivity 
appears to reside, so that these tissues can be removed from the food 
chain. Early epidemiological work identified contaminated feed as the 
primary method of spread of the disease between animals. Continued 
monitoring and surveillance in Europe--where the exposure is assumed to 
be the highest--have demonstrated the effectiveness of control measures 
that have been enacted, such as feed bans that prevent the recycling of 
the agent. This increased body of knowledge provides a sound and 
compelling scientific basis for more focused regulatory restrictions 
with regard to BSE than those we have been operating under.
    A more focused approach is also supported by the international 
community, as evidenced by the evolution of BSE guidelines adopted by 
the OIE (Ref 1). The OIE is recognized by the World Trade Organization 
(WTO) as the international organization responsible for development and 
periodic review of standards, guidelines, and recommendations with 
respect to animal health and zoonoses (diseases that are transmissible 
from animals to humans). The OIE guidelines for trade in terrestrial 
animals (mammals, birds, and bees) are detailed in the Terrestrial 
Animal Health Code (Ref 2). The OIE guidelines on BSE, contained in 
Chapter 2.3.13 of the Terrestrial Animal Health Code, and supplemented 
by Appendix 3.8.4 of the Code, currently provide for five possible BSE 
classifications for regions. For each classification, the guidelines 
recommend different export conditions for live animals and products, 
based on the risk presented by the region. This framework not only 
recognizes different levels of risk among regions, but provides for 
trade in live animals and products under certain conditions even from 
regions considered high-risk under the OIE guidelines.
    As a member of the OIE, the United States, represented by APHIS, 
has been actively involved in the development of OIE guidelines and 
fully supports the OIE position that gradations in BSE risk among 
regions should be recognized and that trade should be commensurate with 
risk. Although APHIS did not incorporate the text of OIE's BSE 
guidelines into its proposed rule, the agency based its standards on 
these guidelines. The standards contain the same basic factors for 
assessing a region's BSE status as the OIE guidelines (e.g., import 
requirements, incidence, surveillance, feed restrictions, etc.). APHIS 
also considered the OIE guidelines, in conjunction with other relevant 
factors and available information, when evaluating Canada as a BSE 
minimal-risk region, and will do so in the future in evaluating other 
countries that may apply for minimal-risk status under our regulations. 
It is in this context that APHIS' standards and the OIE guidelines 
should be viewed.
    We believe it is important to explain the relationship of our 
standards to the OIE guidelines because a number of commenters 
questioned why we did not adopt the OIE guidelines outright and/or 
assumed that differences in text meant that APHIS had rejected the OIE 
guidelines. While there are differences between the APHIS standards and 
the OIE guidelines, these differences reflect the different purposes 
and uses of the OIE guidelines and our standards.
    The OIE guidelines are designed to provide a science-based 
reference document for international trade in animals and animal 
products. To this end, the OIE Terrestrial Animal Health Standards 
Commission draws upon the expertise of internationally renowned 
specialists to draft new and revised articles of the Terrestrial Code 
in light of advances in veterinary science. Draft texts are circulated 
to member countries for review and comment and, as a general rule, are 
adopted based on consensus of the OIE membership. Articles adopted by 
the membership provide guidance for use by veterinary authorities, 
import/export services, epidemiologists and all those involved in 
international trade. OIE guidelines are not intended to be 
prescriptive; each member nation may determine its own appropriate 
level of protection and, therefore, establish its own import 
requirements. (In accordance with Article 5 of the WTO ``Agreement on 
the Application of Sanitary and

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Phytosanitary Measures'' (WTO-SPS Agreement), WTO members are obligated 
to base their import requirements on an assessment of risk, taking into 
account the standards, guidelines, and recommendations, and the risk 
assessment techniques developed by the relevant international 
organizations.)
    Regulations, which may be based on the OIE guidelines, are 
prescriptive, as they are intended to be enforced as written and are 
not designed to be a point of reference. Furthermore, because 
rulemaking may take considerable time, the most successful regulations 
must also be flexible enough to allow a country to consider individual 
circumstances among its trading partners, as well as changes in 
science, without undergoing constant revisions. One reason that APHIS 
has decided not to simply adopt the OIE guidelines as regulations is 
that they are constantly evolving and subject to change. Some chapters, 
in fact, such as the one on BSE, are continually being updated as new 
information becomes available. For example, the OIE is currently 
considering proposing a three-tier country classification system for 
BSE as an alternative to the existing five-tier system. In 2004, the 
OIE changed the recommended reported incidence rate for minimal-risk 
regions from less than 1 case per million during each of the last four 
consecutive 12-month periods within the cattle population over 24 
months of age to less than 2 cases per million during that time period 
within that cattle population. This example of a numeric threshold 
points to another reason that APHIS chose not to adopt the OIE 
guidelines as regulations. In some cases, holding a country to a rigid 
criterion without consideration of compensatory risk reduction measures 
may not be scientifically justified and unfairly discriminate against 
regions where the overall conditions indicate equivalence with minimal 
BSE risk. In other cases, rigidly applying a numeric criterion without 
a thorough consideration and evaluation of relevant factors (e.g., the 
quality of a country's surveillance program and the supporting 
veterinary infrastructure) could result in trade with a region that may 
meet OIE guidelines but, nonetheless, present, in our view, an undue 
risk of BSE introduction. Therefore, rather than incorporate the text 
of the OIE guidelines into our regulations, APHIS chose to base its 
evaluation on OIE guidelines in a way that allows us to consider an 
individual country's specific situation and to analyze risk based on 
the overall effectiveness of actions taken by the country to prevent 
the introduction and spread of BSE.
    As stated above, APHIS considered the OIE guidelines in evaluating 
whether Canada met our proposed standards, and we plan to consider them 
in assessing whether other countries that may apply for minimal-risk 
classification meet our standards. To illustrate how we would use the 
OIE guidelines for minimal-risk regions in applying our own standards, 
we can look to our evaluation of the incidence of BSE with respect to 
Canada. Although APHIS' standards do not include a numerical threshold 
for incidence, our standards provide that a region must have in place 
risk mitigation measures adequate to prevent widespread exposure and/or 
establishment of the disease. In concluding that measures taken in 
Canada had prevented widespread exposure and/or establishment, we 
compared Canada's incidence rate of two infected cattle in 2003 out of 
a population of 5.5 million cattle over 24 months of age with OIE's 
recommendation of less than two infected cattle per million during each 
of the last four consecutive 12-month periods within the cattle 
population over 24 months of age. Canada's incidence rate (0.4 per 
million head of adult cattle) is well below the current OIE 
recommendation regarding incidence in minimal-risk regions. We also 
considered that the reported rate of disease cannot be considered 
independently from either the level and quality of disease surveillance 
or from the position on the epidemic curve. In this regard, we note 
that Canada exceeds the OIE recommended level of testing. We also 
consider Canada's surveillance program for BSE in cattle to be of high 
quality because it includes active surveillance for BSE in cattle that 
is appropriately targeted based on known risk factors. Also, because 
Canada implemented import restrictions and a feed ban before detection 
of BSE in any indigenous animals, it is more likely that the incidence 
of BSE in Canada is decreasing (on the down slope of the epidemic 
curve), rather than increasing (on the up slope).
The November 2003 Proposed Rule
    As explained above, our proposed standards for minimal-risk regions 
were based on the OIE guidelines for BSE minimal-risk regions, using 
those guidelines as a reference. We based our proposed classification 
of Canada as a minimal-risk region, as well as our proposed mitigation 
measures for live ruminants and ruminant products and byproducts from 
Canada, on an analysis of risk APHIS prepared entitled, ``Risk 
Analysis: BSE Risk from Importation of Designated Ruminants and 
Ruminant Products from Canada into the United States.'' The analysis 
drew on a number of sources of information, including scientific 
literature, results of epidemiological investigations, data provided by 
the Canadian Government, a quantitative analysis (i.e., uses numerical 
values) of the risk of BSE in Canada prepared by the Canadian Food 
Inspection Agency (CFIA), and quantitative analyses of the consequences 
of BSE being introduced into the United States prepared by the Harvard 
Center for Risk Analysis at Harvard University (HCRA) and the Center 
for Computational Epidemiology at Tuskegee University (Ref 3) 
(discussed in more detail below under the heading ``Harvard-Tuskegee 
Investigation of BSE Risk in the United States''). This analysis was 
made available to the public when the proposed rule was published in 
November 2003.
    We solicited public comment on the proposed rule and its underlying 
risk analysis and other supporting analyses for 60 days ending on 
January 5, 2004. As noted, at the time the proposed rule was published, 
BSE had never been detected in a native animal in the United States, 
and only a single case in a native animal had been reported in Canada 
(in Alberta in May 2003).
The Reopening of the Comment Period and Explanatory Note
    On December 23, 2003, less than 2 weeks before the close of the 
comment period for our proposed rule, USDA announced a presumptive 
positive case of BSE in a dairy cow in Washington State. Samples had 
been taken from the cow on December 9 as part of USDA's BSE 
surveillance program. The BSE diagnosis was made on December 22 and 23 
by histopathology and immunohistochemical testing at the National 
Veterinary Services Laboratories in Ames, IA, and was verified on 
December 25 by the international reference laboratory, the Veterinary 
Laboratories Agency in Weybridge, England.
    Upon detection of the BSE-positive cow in Washington State, USDA, 
FDA, and other Federal and State agencies, along with CFIA, immediately 
began working together to perform an epidemiological investigation (Ref 
4), trace any potentially infected cattle, trace potentially 
contaminated rendered product, increase BSE surveillance, and take 
additional measures to address human and animal health.

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    The epidemiological investigation and DNA test results confirmed 
that the infected cow was not indigenous to the United States, but 
rather was born and most likely became infected in Alberta, Canada, 
before Canada's 1997 implementation of a ban on feeding mammalian 
protein to ruminants.
    Following detection of the imported BSE-infected cow in Washington 
State in December 2003, further safeguards on human and animal health 
were implemented in the United States by FDA and FSIS. These actions 
are described in more detail below under the headings ``Measures 
Implemented by FSIS'' and ``Measures Implemented by FDA.''
    In response to comments from the public requesting an extension of 
the comment period and in order to give the public an additional 
opportunity to comment on the proposed rule in light of these 
developments, on March 8, 2004, we published a notice in the Federal 
Register (69 FR 10633-10636, Docket No. 03-080-2) reopening and 
extending the comment period until April 7, 2004. The notice also 
announced the availability of a document titled ``Explanatory Note'' 
that discussed each component of the original risk analysis and related 
information in light of the new BSE case. (You may view the Explanatory 
Note document on the Internet by accessing the APHIS Web site at http:/
/www.aphis.usda.gov/lpa/issues/bse/bse.html. Click on the document 
titled ``Analysis of Risk--Update for the Final Rule: Bovine Spongiform 
Encephalopathy; Minimal Risk Regions and Importation of Commodities, 
December 2004.'')
    The Explanatory Note stated that APHIS did not consider the 
detection of a second BSE case to have an effect on the conclusions of 
the original risk analysis and explained why. The original risk 
analysis addressed the likelihood that animals might have been infected 
before Canada implemented its feed ban in 1997 and also concluded that 
compliance with the feed ban in Canada would have minimized the 
likelihood of infectivity from these animals spreading to other 
ruminants in Canada.
    As noted above, the epidemiological investigation and DNA test 
results indicated that the infected cow most likely became infected 
before Canada's 1997 implementation of a ban on feeding mammalian 
protein to ruminants. Both animals diagnosed with BSE were older than 
30 months of age. The cow found to have BSE in December 2003 also was 
imported into the United States when it was older than 30 months; the 
proposed rule would not have allowed the importation of cattle 30 
months of age or older.
    The Explanatory Note observed further that, although an additional 
animal of Canadian origin had been diagnosed with BSE since the time 
APHIS published its November 2003 proposed rule and risk analysis, the 
fact remained that only two cases of BSE had been detected in animals 
born in Canada. The Explanatory Note also discussed the additional BSE 
control measures taken by Canada after BSE had been detected in that 
country.
    The March 2004 notice that reopened and extended the comment period 
on our proposed rule also proposed allowing the importation of beef 
from Canada, regardless of the age of the cattle from which it was 
derived, provided other specified mitigating conditions were met, and 
invited comment on this change from our November 2003 proposal. The 
original proposal would have required the beef to come from cattle that 
were less than 30 months of age at the time of slaughter.
    We explained in the notice that the change in our thinking was 
based on the changes FSIS made in its regulations in January 2004, and 
the fact that Canada had also implemented the changes made by FSIS. 
Among other things, FSIS required that cattle tissues considered at 
particular risk of containing the BSE agent in infected animals 
(referred to as ``specified risk materials'' or SRMs) be removed from 
cattle at slaughter and prohibited their use in human food. FSIS 
designated as SRMs the brain, skull, eyes, trigeminal ganglia, spinal 
cord, vertebral column (excluding the vertebrae of the tail, the 
transverse process of the thoracic and lumbar vertebrae, and the wings 
of the sacrum), and dorsal root ganglia of cattle 30 months of age and 
older, and the tonsils and distal ileum of the small intestine of all 
cattle. To ensure effective removal of the distal ileum, FSIS also 
required that the entire small intestine be removed and be disposed of 
as inedible. FSIS did not restrict the age of cattle eligible for 
slaughter, because the removal of SRMs effectively mitigates the BSE 
risk to humans associated with cattle that pass both ante-mortem and 
post-mortem inspections (i.e., apparently healthy cattle); FSIS and FDA 
regulations prohibit the use of other cattle in human food. The 
Canadian Government had already established equivalent safeguards in 
Canada in July 2003. In addition, because regions wishing to export 
meat and meat products to the United States must follow processing 
practices equivalent to those of FSIS, the FSIS requirements 
effectively require removal of SRMs from all cattle slaughtered outside 
the United States when meat derived from those cattle is intended for 
export to the United States, which would prevent such materials from 
entering the food chain in the United States. Additionally, FDA's feed 
ban prohibits ruminant protein from entering the ruminant feed chain. 
Therefore, we stated in our notice that we did not believe it was 
necessary to require that beef imported from BSE minimal-risk regions 
be derived from cattle under 30 months of age, provided measures 
equivalent to those of FSIS regarding SRM removal are in place in the 
exporting region and provided such other measures as are necessary 
(e.g., a prohibition on the use of air injection stunning devices, 
controls to prevent cross-contamination) are in place.
    We received a total of 3,379 comments on the proposed rule from the 
public by the close of the comment period on April 7, 2004.

C. Background Information for APHIS' Response to Comments

    Before discussing the comments received, we consider it useful to 
discuss a number of documents and actions that contributed to the basis 
for our establishment of a BSE minimal-risk region category and our 
inclusion of Canada in that category. These include: Measures 
implemented by FSIS and FDA to further reduce BSE risk in the United 
States; the Harvard-Tuskegee investigations of BSE risk in the United 
States; a memorandum from Joshua Cohen and George Gray of the HCRA; 
measures taken in Canada in response to BSE risk prior to May 2003; a 
2002 Canadian assessment of BSE risk in that country; the 
epidemiological investigation and a report by an international review 
team following the diagnosis of BSE in a cow in Canada in May 2003; 
additional measures taken in Canada; and an update to the APHIS 
analysis of the risk of allowing the importation of ruminants and 
ruminant products and byproducts from Canada.
Roles of Different Agencies
    Protecting human and animal health from the risks of BSE is carried 
out on the Federal level primarily by APHIS regarding animal health and 
FSIS regarding food safety, in coordination with the following FDA 
Centers: The Center for Veterinary Medicine regarding animal feed; the 
Center for Food Safety and Applied Nutrition regarding foods other than 
meat, poultry, and egg products; and other Centers regarding drugs, 
biologics, and

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devices containing bovine material. These agencies collaborate, issuing 
regulations under their respective authorities, to implement a 
coordinated U.S. response to BSE.
    APHIS is promulgating this final rule under the authority of the 
Animal Health Protection Act, which gives the Secretary broad 
discretion to regulate the importation of animals and animal products 
when he or she determines it to be necessary. As discussed below, FSIS 
and FDA have recently published regulations regarding BSE to protect 
human health. Because of the specific focus of each of these three 
agencies, provisions for similar products may sometimes differ slightly 
in the agencies' respective regulations as appropriate based on the 
intended consumer.
Measures Implemented by FSIS
    FSIS, in a series of three interim final rules that were published 
and made effective on January 12, 2004, took additional measures to 
prevent the BSE agent from entering the human food supply. In its 
interim final rule titled, ``Prohibition on the Use of Specified Risk 
Materials for Human Food and Requirements for the Disposition of Non-
Ambulatory Disabled Cattle'' (FSIS Docket No. 03-025IF; 69 FR 1861), 
and referred to below as the SRM rule, FSIS designated certain cattle 
tissues as SRMs and prohibited their use in human food. As noted 
earlier, FSIS designated as SRMs the brain, skull, eyes, trigeminal 
ganglia, spinal cord, vertebral column (excluding the vertebrae of the 
tail, the transverse process of the thoracic and lumbar vertebrae, and 
the wings of the sacrum), and dorsal root ganglia of cattle 30 months 
of age and older, and the tonsils and distal ileum of the small 
intestine of all cattle as SRMs. FSIS also required removal of the 
entire small intestine and disposal of it as inedible to ensure 
effective removal of the distal ileum.
    To facilitate enforcement of the SRM rule, FSIS has developed 
procedures to verify the approximate age of cattle that are slaughtered 
in official establishments. Such procedures, based on records or 
examination of teeth, are intended to ensure that SRMs from cattle 30 
months of age and older are effectively segregated from edible 
materials (Ref 5).
    As provided by the SRM rule, materials designated as SRMs if they 
are from cattle 30 months of age and older will be deemed to be SRMs 
unless the establishment can demonstrate that they are from an animal 
that was younger than 30 months of age at the time of slaughter.
    Further, FSIS developed procedures to verify that cross-
contamination of edible tissue with SRMs is reduced to the maximum 
extent practical in facilities that slaughter cattle or process 
carcasses or parts of carcasses of cattle, for cattle both younger than 
30 months of age and 30 months of age and older (Ref 5).
    The SRM rule also declared mechanically separated beef (MS(beef)) 
to be inedible and prohibited its use for human food. Additionally, the 
SRM rule prohibited all non-ambulatory disabled cattle for use as human 
food.
    The second interim final rule, titled ``Meat Produced by Advanced 
Meat/Bone Separation Machinery and Meat Recovery (AMR) Systems'' (FSIS 
Docket No. 03-038IF; 69 FR 1874-1885), prohibited products produced by 
advanced meat recovery (AMR) systems from being labeled as ``meat'' if, 
among other things, they contain central nervous system (CNS) tissue. 
AMR is a technology that enables processors to remove the attached 
skeletal muscle tissue from livestock bones without incorporating 
significant amounts of bone and bone products into the final meat 
product. FSIS had previously established and enforced regulations that 
prohibited spinal cord from being included in products labeled 
``meat.'' The interim final rule expanded that prohibition to include 
dorsal root ganglia (DRG)--clusters of CNS tissue connected to the 
spinal cord along the vertebral column. In addition, because the 
vertebral column and skull of cattle 30 months of age and older have 
been designated as SRMs, they cannot be used for AMR. Because they are 
not SRMs, the skull and vertebral column from cattle younger than 30 
months of age are allowed to be used in AMR systems. However, 
establishments that use skulls and vertebral columns in the production 
of beef AMR product must be able to demonstrate that such materials are 
from cattle younger than 30 months of age.
    The third interim final rule, titled ``Prohibition on the Use of 
Certain Stunning Devices Used to Immobilize Cattle During Slaughter'' 
(FSIS Docket No. 01-0331IF; 69 FR 1885-1891), prohibited the use of 
penetrative captive bolt stunning devices that deliberately inject air 
into the cranial cavity of cattle, because the use of such devices may 
force large fragments of CNS tissue into the circulatory system of 
stunned cattle where the fragments may become lodged in edible tissues.
    Also on January 12, 2004, FSIS published a notice, ``Bovine 
Spongiform Encephalopathy Surveillance Program,'' announcing it would 
no longer pass and apply the mark of inspection to carcasses and parts 
of cattle selected for BSE testing by APHIS until the sample testing 
has been completed, and the result is negative (FSIS Docket No. 03-
048N; 69 FR 1892).
Measures Implemented by FDA
    FDA, like FSIS, has taken additional measures to prevent the BSE 
agent from entering the human food supply. In an interim final rule 
published in the Federal Register on July 14, 2004, ``Use of Materials 
Derived from Cattle in Human Food and Cosmetics,'' FDA prohibited SRMs 
(the same as defined by FSIS), the small intestine of all cattle, 
material from non-ambulatory disabled cattle, material from cattle not 
inspected and passed for human consumption, and MS(beef) from use in 
FDA-regulated human food, including dietary supplements, and cosmetics 
(69 FR 42255; FDA Docket No. 2004N-0081).
    In an advance notice of proposed rulemaking issued jointly by FDA, 
FSIS, and APHIS on July 14, 2004, ``Federal Measures to Mitigate BSE 
Risks: Considerations for Further Action'' (69 FR 42288-42300, FDA 
Docket No. 2004N-0264, FSIS Docket No. 04-021ANPR, APHIS Docket No. 04-
047-1), FDA requested additional information to help it determine the 
best course of action to reduce the already small risk of BSE spread 
through animal feed. (We refer to the advance notice of proposed 
rulemaking below as the ``USDA/FDA joint notice.'')
    FDA continues to conduct inspections to monitor compliance of 
domestic feed mills, renderers, and protein blenders with regulations 
it put in place in 1997 to prevent recycling of potentially infectious 
cattle tissue through ruminant feed. (FDA regulations at 21 CFR 
589.2000 prohibit the feeding of most mammalian protein to ruminants in 
the United States.) FDA also has expanded the scope of its 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 is currently very high. As of July 2004, 
conditions or practices warranting regulatory sanctions had been found 
in less than 1 percent of inspected facilities (Ref 6).
Harvard-Tuskegee Investigation of BSE Risk in the United States
    In April 1998, USDA commissioned the HCRA at Harvard University and 
the Center for Computational Epidemiology at Tuskegee University to 
conduct a comprehensive investigation of BSE risk

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in the United States. The report was completed in 2001 and released by 
the USDA. Following a peer review of the Harvard-Tuskegee Study in 2002 
(Ref 7), the authors responded to the peer review comments (Ref 8) and 
released a revised risk assessment in 2003 (Ref 3). The report, widely 
referred to as the Harvard Risk Assessment or the Harvard Study, is 
referred to in this document as the Harvard-Tuskegee Study.
    The Harvard-Tuskegee Study reviewed available scientific 
information related to BSE and other TSEs, assessed pathways by which 
BSE could potentially occur in the United States, and identified 
measures that could be taken to protect human and animal health in the 
United States. The assessment concluded that the United States is 
highly resistant to any amplification of BSE or similar disease and 
that measures taken by the U.S. Government and industry make the United 
States robust against the spread of BSE to animals or humans should it 
be introduced into this country.
    The Harvard-Tuskegee Study concluded that the most effective 
measures for preventing the potential spread of BSE are: (1) The ban 
placed by APHIS on the importation of live ruminants and ruminant meat-
and-bone meal from the United Kingdom since 1989 and all of Europe 
since 1997; and (2) the feed ban instituted in 1997 by FDA. The 
Harvard-Tuskegee Study further indicated that, if introduction of BSE 
had occurred via importation of live animals from the United Kingdom 
before 1989, mitigation measures in place in the United States at the 
time the Study was conducted would have minimized exposure and worked 
to eliminate the disease from the U.S. cattle population.
    The Harvard-Tuskegee Study also identified three practices that 
could create a pathway for human exposure to the BSE agent or the 
spread of BSE should it be introduced into the United States: (1) Non-
compliance with FDA's regulations prohibiting the use of certain 
proteins in feed for cattle and other ruminants; (2) rendering of 
animals that die on the farm and use (through illegal diversion or 
cross-contamination) of the rendered product in ruminant feed; and (3) 
the inclusion of high-risk tissues from cattle, such as brain and 
spinal cord, in products for human consumption.
    The Harvard-Tuskegee Study's independent evaluation of the 
potential risk mitigation measures predicts that a prohibition against 
rendering of animals that die on the farm would reduce the number of 
potential cases of BSE in cattle following hypothetical exposure by 82 
percent as compared to the base case scenario, and that a ban on SRMs 
(which included, according to the evaluation, the brain, spinal cord 
and vertebral column, ``gut,'' and eyes) from inclusion in human and 
animal food would reduce potential BSE cases in cattle by 88 percent 
and potential human exposure to BSE by 95 percent as compared to the 
base case scenario (Ref 9).
    In 2003, following the identification of BSE in a native-born cow 
in Canada, USDA, working with HCRA, evaluated the implications of a 
then-hypothetical introduction of BSE into the United States from 
Canada, using the same simulation model developed for the initial 
Harvard-Tuskegee Study. This assessment, titled ``Evaluation of the 
Potential Spread of BSE in Cattle and Possible Human Exposure Following 
Introduction of Infectivity into the United States from Canada'' (Ref 
10), confirmed the conclusions of the earlier Harvard-Tuskegee Study--
namely, that a very low risk exists of BSE becoming established or 
spreading should it be introduced into the United States.
Cohen and Gray Memorandum
    Following receipt of comments from the public on its November 2003 
proposed rule, APHIS requested the HCRA to respond to comments that 
pertained to the Harvard-Tuskegee Study. The HCRA's response to the 
comments, authored by Joshua Cohen and George Gray, was reported to 
APHIS in a June 18, 2004, memorandum, referred to below as ``the Cohen 
and Gray memorandum.'' The memorandum also updates the model used in 
the Harvard-Tuskegee Study with new data from the FDA addressing two 
critical model parameters--mislabeling of products containing 
prohibited ruminant protein and contamination of nonprohibited protein 
with prohibited protein. You may view the memorandum on the Internet by 
accessing the APHIS Web site at https://www.aphis.usda.gov/lpa/issues/
bse/bse.html. Click on the document titled ``Analysis of Risk--Update 
for the Final Rule: Bovine Spongiform Encephalopathy; Minimal Risk 
Regions and Importation of Commodities, December 2004.''
Measures Taken in Canada in Response to BSE Risk Prior to May 2003
    Import restrictions. Canada imposed import restrictions to guard 
against the introduction of BSE, starting in 1990. In that year, Canada 
prohibited the importation of live cattle from the United Kingdom and 
the Republic of Ireland. In 1994, an import ban was imposed on all 
countries where BSE had been detected in native cattle. 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 following a comprehensive risk assessment. Some animals were 
imported into Canada from high-risk 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.
    Canada has also restricted the importation of ruminant products, 
including meat-and-bone meal, since 1978. In general, Canada has 
prohibited the importation of most meat-and-bone meal from countries 
other than the United States, Australia, and New Zealand. Limited 
amounts of specialty products of porcine or poultry origin have been 
allowed to be imported into Canada under permit for use in aquaculture 
feed products. No meat-and-bone meal for livestock feed-associated uses 
has been imported, except from the United States, Australia, and New 
Zealand.
    Feed ban. A crucial element in preventing the spread and 
establishment of BSE in a country is the implementation of a ruminant-
to-ruminant feed ban. Canada implemented a feed ban in 1997 that 
prohibits the feeding of most mammalian protein 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 equivalent to the 
feed ban in place in the United States, with the addition that Canada 
prohibits the feeding of plate waste and poultry litter to ruminants.
    Canada has provided information, including statistics on 
compliance, demonstrating that an effective feed ban is in place in the 
rendering, feed manufacturing, and livestock raising industries. Few 
cattle born before implementation of the Canadian feed ban are alive 
today, given that most male cattle are slaughtered before 24 months of 
age and given the normal cull rates for beef and dairy cows. It is 
estimated that 39.4 percent of the beef cattle born in 1996 are alive 
today. It is estimated that 5.8 percent of the dairy cattle born in 
1996 are alive today.

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Infected animals typically exhibit clinical signs of BSE 4 to 6 years 
after infection, and 95 percent of infected cattle exhibit clinical 
signs in less than 7 years. Since cattle born before the feed ban would 
now be 7 years of age or older, any remaining infected cattle, if 
present, would likely be showing clinical signs of BSE that would allow 
their detection through Canada's BSE surveillance system.
    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. CFIA indicates that, with respect to 
the inedible rendering sector, full compliance with the feed ban 
requirements has been consistently achieved, and that, with respect to 
the Canadian commercial feed industry, CFIA has identified 
noncompliance of ``immediate concern'' in fewer than 2 percent of feed 
mills inspected during 2003-2004. Those instances of noncompliance of 
``immediate concern'' are dealt with when identified. According to 
CFIA, noncompliance of immediate concern includes situations where 
direct contamination of ruminant feed with prohibited materials has 
occurred, as identified through inspections of production documents or 
visual observation, and where a lack of appropriate written procedures, 
records, or product labeling by feed manufacturers may expose ruminants 
to prohibited animal proteins (Ref 11).
    Surveillance. Canada has an adult cattle population of 
approximately 5.5 million cattle older than 24 months of age. The 
current OIE Code, Appendix 3.8.4, references adult cattle populations 
as those greater than 30 months and recommends examining at least 300 
samples per year from high-risk animals in a country with an adult 
cattle population of 5 million, or 336 samples per year in a country 
with an adult cattle population of 7 million. Even though the adult 
cattle population in Canada is defined as greater than 24 months of age 
and OIE defines it as greater than 30 months of age, Canada has met or 
exceeded this level of surveillance for the past 7 years, thus 
exceeding the OIE guidelines. Active targeted surveillance was begun in 
Canada in 1992, with numbers of annual samples ranging from 225 in 1992 
to current levels of over 15,800 per year. This surveillance has 
continued to be targeted surveillance, with samples obtained from adult 
animals exhibiting some type of clinical signs or considered high risk 
for other reasons that could be considered consistent with BSE. During 
the time Canada has been conducting surveillance for BSE, BSE has been 
detected in only two cattle indigenous to Canada--the cows diagnosed 
with BSE in May and December 2003.
Canadian 2002 BSE Risk Assessment
    In December 2002, CFIA issued an assessment of the risk of BSE in 
Canada. The assessment evaluated BSE risk factors and correlating risk 
mitigation measures being taken in Canada, as well as surveillance 
being conducted in that country to detect any BSE-infected animals. The 
risk assessment analyzed the possibility that BSE infectivity was 
introduced into Canada through 665 cattle imported into Canada from 
Europe between 1979 and 1997, when Canada implemented its feed ban. The 
analysis indicated a low potential for cumulative introduction of 
infectivity into Canada via these cattle and further suggested that the 
likelihood of the spread and establishment of BSE in Canada, both 
before and after the 1997 feed ban, was negligible (Ref 12).
Epidemiological Investigation and a Report by an International Review 
Team
    On May 20, 2003, CFIA reported a case of BSE in a beef cow in 
northern Alberta. Following the detection of the BSE-infected cow, 
Canada conducted an epidemiological investigation of the BSE 
occurrence, working with, among others, APHIS representatives. The 
epidemiological investigation showed that the animal was born before 
implementation of the feed ban in 1997, and that exposure likely 
occurred prior to or near the time of the imposition of the feed 
regulations. Although a specific source of infection was not 
identified, the most likely source of exposure was feed that contained 
protein from an infected animal imported from the United Kingdom 
between 1982 to 1989.
    Additionally, the epidemiological investigation focused on rendered 
material or feed that could have been derived from the carcass of the 
infected cow. As part of that investigation, a survey was conducted of 
approximately 1,800 sites that were at some risk of having received 
such rendered material or feed. The survey suggested that 99 percent of 
the sites surveyed experienced either no exposure of cattle to the feed 
(96 percent of the sites) 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. 
Depopulation of Canadian herds possibly exposed to the feed in question 
was carried out by the Canadian Government. Canadian officials 
conducted a wide-ranging investigation of possible exposure to the feed 
in question and carried out depopulation of Canadian herds possibly 
exposed to the feed. On each of those farms where the investigation 
could not rule out the possibility of exposure to feed that may have 
contained rendered protein from the infected animal, the herds were 
slaughtered and tested. All of those animals tested negative for BSE 
and their carcasses were disposed of in ways, such as disposal in 
landfills, to ensure that they did not go into the animal food chain 
(Ref 13).
    In June 2003, an international review team (IRT) of animal disease 
experts assessed the CFIA's investigation of the May 2003 case of BSE 
and Canada's overall protective measures. The IRT noted the quality of 
the Canadian investigation and the effectiveness of protective measures 
in place in Canada. The IRT recommended a number of actions to further 
enhance the safety of human and animal health, including putting in 
place a national requirement that SRMs be removed from products 
destined for consumption; a review of animal feed restrictions; 
strengthened tracking and tracing systems; improved disease testing and 
surveillance; and additional efforts to improve disease awareness among 
producers, veterinarians, and the public (Ref 14).
Additional Measures Taken in Canada
    Response to the IRT Report. Subsequent to the IRT report, in July 
2003 Canada implemented the requirement that SRMs be removed from 
cattle at slaughter (Ref 15). Additionally, Canada implemented enhanced 
measures for identification and for tracking and tracing, as well as 
for increased BSE surveillance and testing. We discuss the increased 
surveillance and testing in greater detail below. (Ref 16).
    Epidemiological Investigation of the Case in Washington State. As 
noted above, in December 2003, BSE was detected in a Canadian-origin 
cow in Washington State