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

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URL: https://www.frixlaw.com/law-library/documents/fr%3A04-28593

## Record

- **Collection:** Federal Register
- **Document type:** Rule
- **Published:** January 4, 2005
- **Citation:** 70 FR 460

## Text

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.

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∧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 § 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 § 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

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 § 93.436 to § 93.405 and § 93.419.

5. We are moving the provisions for the importation of sheep and goats from Canada for immediate slaughter from proposed § 93.436 to § 93.419 and § 93.420.

6. We are clarifying in § 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 § 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 § 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 § 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

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.

ER04JA05.010

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

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

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.

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

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

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
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.”

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.

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. Canada, along with the United States, conducted a rigorous epidemiological investigation. As with the May 2003 case, the epidemiological investigation showed that the animal was born in Canada before implementation of the feed ban in 1997 and, in all likelihood, was exposed to

BSE before or near the time the Canadian feed ban was imposed. As with the May 2003 case, although a specific source of infection was not identified, the investigation indicated that the most likely source of exposure was feed that contained protein from an infected animal imported from the United Kingdom between 1982 to 1989. Again, the investigation resulted in the destruction and testing of a large number of potentially exposed cattle, and testing resulted in no further evidence of infection.

Increased Surveillance.
In January 2004, the Canadian Government announced that it would increase its level of BSE testing. As of December 1, 2004, Canada had tested more than 15,800 animals for BSE in 2004, all with negative results, and has announced its goal of testing at least 30,000 animals in 2005. The surveillance program focuses on testing high-risk cattle: dead, dying, diseased, and down cattle over 30 months of age and cattle showing neurological symptoms consistent with BSE. This level of testing represents a significant increase over previous testing levels; surveillance levels in Canada have increased to current levels from under 500 animals per year in 1996.

Update to APHIS’ Risk Analysis and Summary of Mitigation Measures and Their Applicability to Canada as a BSE Minimal-Risk Region

In order to add transparency to APHIS' basis for establishing a BSE minimal-risk category and including Canada in that category, we are making available a separate update of factors and measures that mitigate the risk of BSE and their applicability to imports from Canada. This update, titled “Analysis of Risk-Update for the Final Rule: Bovine Spongiform Encephalopathy; Minimal Risk Regions and Importation of Commodities, December 2004,” can be viewed on the Internet 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 update extends the discussions APHIS provided previously in its risk analysis, explanatory note, proposed rule, and notice extending the comment period. In the update, we summarize the APHIS standards for a BSE minimal-risk region and the factors considered in our evaluation of such a region. We expand on our considerations of Canada as a minimal-risk region in the context of those standards. In accordance with OIE guidelines (Chapter 1.3.2), the original analysis had four major components: (1) Release assessment; (2) exposure assessment; (3) consequence assessment; and (4) risk estimation. In the update, we discuss in detail two of these four components—the release assessment and exposure assessment—and provide, in more depth, data relevant to our consideration of BSE risk. Finally, the update addresses information that has become available subsequent to our original analysis.

IV. Comments From the Public

As noted above, we received a total of 3,379 comments from the public by the close of the comment period on April 7, 2004. They were from members of Congress, representatives of State and local governments, livestock producers, importers and exporters, organizations representing livestock producers, organizations representing processors and distributors of animal products and byproducts, individual companies, representative of foreign governments, a national animal health association, human health associations, the academic community, and other members of the public.

Subjects of Comments Received

A number of commenters supported the rule and recommended no changes to the proposed provisions. Other commenters supported the rule in general but recommended certain changes to the proposed provisions. Others comments consisted only of recommended changes, objections to the rule in general or to specific provisions, or requests for clarification. In general, the comments we received on the proposed rule can be categorized as follows:

• Comments on the proposed standards for BSE minimal-risk regions;

• omments on whether Canada should be recognized as a minimal-risk region;

• Comments on the proposed risk mitigation measures for the importation of live ruminants from Canada;

• Comments on the proposed risk mitigation measures for the importation of ruminant meat and meat products derived from animals in Canada;

• Comments on the risk analysis;

• Comments on the economic analysis;

• Comments on the environmental analysis;

• Comments advocating that we delay implementation of this rule or withdraw the proposal;

• Comments on miscellaneous issues related to the proposed rule.

We discuss these comments by topic below.

Clarification

We note that, in order to clarify our intent in this final rule, we are making a change to the proposed minimal-risk standards that was not addressed by commenters. One of the standards we proposed to evaluate for a BSE minimal-risk region was whether 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. In this final rule, we are clarifying that the BSE detection referred to in that factor is detection in an animal indigenous to the region, consistent with the OIE guidelines for BSE. We are making this change to distinguish between the risk of BSE from detection in indigenous animals and imported animals. In this regard, detection of the disease in an indigenous animal suggests that transmission of the agent has occurred in the region, whereas an imported case does not.

In this final rule, we are making several other clarifications of our regulations. These additional clarifications are discussed below, following the discussion of comments, under the heading “V. Additional Clarifications.”

A. Proposed Standards for BSE Minimal-Risk Regions

Some of the comments we received on our proposed rule agreed with the standards proposed for a BSE minimal-risk region and supported our proposed classification of Canada as such a region. However, a number of other commenters questioned the clarity of and basis for the BSE minimal-risk standards. Others disagreed that Canada should be considered such a region.

Proposed Minimal-Risk Standards in General

Issue:
One commenter requested that APHIS reconsider the approach of establishing a category of BSE minimal-risk region. The commenter stated that, because OIE already lists a category very similar to APHIS’ BSE minimal-risk category, referring to “minimal risk” in the proposal is an unnecessary duplication of definitions and could lead to confusion. The commenter also suggested that APHIS link definitions and the consequent treatment of animals and meat products to the OIE Code. Several commenters said that APHIS should not adopt criteria for BSE minimal-risk regions that differ from

OIE guidelines for BSE minimal-risk regions or questioned APHIS’ basis for doing so. One of these commenters stated that OIE guidelines have highly detailed and specific criteria that allow the identification of minimal-risk regions and said that APHIS did not provide sufficient analysis in the proposed rule to support the creation of a new minimal-risk category. Some others said that APHIS did not adequately describe the scientific basis for deviating from the OIE guidelines, particularly with respect to time during which ruminant feed restrictions have been in place.

Response:
We are making no changes based on these comments. We consider the definition of
BSE minimal-risk region
in this rule to be clear. We have explained our reasoning in detail for adopting performance standards for the critical factors, and discussed at some length our conclusion that some regulatory flexibility is essential. We noted the that the OIE guidelines are fluid, and discussed above in section III. B., under the heading “APHIS' Regulatory Approach to BSE: Past and Present,” that OIE may revise its BSE classifications in the near future.

As discussed above in section III. B. under the heading “More Focused Regulatory Restrictions,” although APHIS did not incorporate the text of OIE's BSE guidelines into its proposed rule, the agency based its standards on those guidelines, and the APHIS standards contain the same essential factors for assessing a region's BSE status as the OIE guidelines (
e.g.
, import requirements, incidence, surveillance, feed restrictions, etc.). The proposed rule and associated risk analysis explain where APHIS' proposed standards for minimal-risk regions departed from OIE guidelines. The preamble to the proposed rule discussed how we would use those standards to evaluate the BSE risk of a region. We said we would use the standards as a combined and integrated evaluation tool in evaluating a region, focusing on the overall effectiveness of all control mechanisms in place (
e.g.
, surveillance, import controls, and a ban on the feeding of ruminant protein to ruminants). We further explained that, in regions where BSE had been diagnosed, we would base our evaluation on the overall effectiveness of all control mechanisms in place at the time BSE was diagnosed in the region, and on actions taken after the diagnosis (
e.g.
, the epidemiological investigation of the occurrence). We agree that this approach differs from the OIE's in that it does not adhere to specific numerical recommendations specified in some of the OIE guidelines, but, as discussed earlier, the OIE guidelines are in flux and are meant to be a reference document. Further, disqualification of a region for failure to precisely meet one OIE recommendation would not account for a region's potential to present an overall minimal risk for BSE by exceeding other OIE recommendations or other relevant factors bearing on a risk to animal health.

We discussed in the proposed rule's preamble how we applied our standards for minimal risk to an evaluation of Canada's BSE risk. For example, we stated that, although Canada has had a feed ban in place for only 7 years (1 year less than provided for by OIE), this time period may be conservative because of the variability in the incubation period for BSE. Based on an analysis of data collected in the United Kingdom, the Harvard-Tuskegee Study (Ref 17) estimates that the variability distribution for the BSE incubation period in cattle has a median (50th percentile) of approximately 4 years and a 95th percentile of approximately 7 years. Based on the best-fit parameter values provided in the Harvard-Tuskegee Study (Ref 18), the mean (expected value) of the incubation period distribution is estimated at 4.2 years, and 7.5 years (August 1997 through January 2005) represents the estimated 97.5th percentile of the incubation period. We determined that the duration of the feed ban in Canada adequately addresses the expected BSE incubation period, taking into consideration all of the actions Canada has taken to prevent the introduction and control the spread of BSE (
e.g.
, import controls, level and quality of surveillance, effectiveness of feed ban, epidemiological investigation of detected cases, and depopulation of herds possibly exposed to suspected feed sources). We, therefore, concluded that a feed ban of less than 8 years' duration was appropriate for Canada. Canada, in fact, meets all OIE guidelines for a minimal-risk region, except for the duration of its feed ban.

We also note that OIE's guidelines for BSE include not just guidelines for classifying regions according to risk, but corresponding guidelines for trade in cattle, meat, and meat products from regions, according to the region's BSE risk classification. Our rule is consistent with this two-part OIE approach of considering a region's overall BSE risk status in combination with appropriate import restrictions for specific commodities.

Issue:
A few commenters said that adopting criteria less stringent than OIE guidelines could result in other countries' perceiving the United States as having a greater BSE risk status and, therefore, prohibiting or restricting imports of cattle and beef from the United States. One commenter observed that OIE has five risk classifications for regions and said that, while some countries may choose to trade with high-risk regions, the United States should trade only with countries determined to be free of BSE.

Response:
We are working diligently on an international level to ensure that BSE-related trade restrictions are based on sound science and a realistic understanding of the risks presented by the commodities we are proposing for trade. We do not believe it is appropriate to limit trade in cattle, meat, and meat products only to regions determined to be free of BSE if there are measures that can be applied to mitigate the risk of those commodities introducing BSE into the United States. There are such mitigation measures, consistent with those we have proposed. In fact, OIE guidelines provide for trade in cattle of any age, as well as beef and many other cattle products, even from countries that are considered high risk for BSE.

Issue:
One commenter said that he was not opposed to APHIS' adopting criteria for minimal-risk regions that differ from OIE guidelines, but that APHIS' criteria put too much emphasis on import controls and epidemiological investigations and not enough on risk management measures in a country under consideration. The commenter mentioned a variety of risk mitigation measures in place in the European Union, including removal of SRMs; a ban on the feeding of mammalian meat-and-bone meal (MBM) to cattle, sheep, and goats; a suspension on the use of processed animal protein in feeds for any animals farmed for the production of food since January 2001, with the exception of fish meal for pigs and poultry; high processing standards for the treatment of ruminant animal waste; surveillance measures in accordance with the OIE Code; an ongoing awareness program for veterinarians; compulsory notification of all cattle showing clinical signs of BSE; testing of risk animals (fallen stock, emergency slaughtered animals, and animals with clinical signs at post-mortem inspection) over 24 months of age and healthy slaughtered animals over 30 months of age; culling policy for animals with a high probability of receiving the same potentially infected feed as a BSE case and offspring of female BSE cases; approval of rapid tests with the same sensitivity as the confirmatory methods.

Response:
We agree with the commenter regarding the effectiveness of an integrated BSE risk management approach, and APHIS' standards for minimal-risk regions consider risk management measures such as those mentioned by the commenter. As discussed above, the standards we proposed for a BSE minimal-risk region included the need for risk mitigation measures to have been in place even before detection of BSE. These would be considered under the broad criteria that form our definition of minimal-risk region. Specifically, those standards include: (1) Having in place risk mitigation measures adequate to prevent widespread exposure and/or establishment of the disease, including import restrictions, surveillance for BSE at levels that meet or exceed OIE recommendations, and a ban on the feeding of ruminant protein to ruminants; (2) conducting, in regions where BSE has been detected, an epidemiological investigation sufficient to confirm the adequacy of measures to prevent the further introduction or spread of BSE; and (3) taking additional risk mitigation measures, as necessary, in regions where BSE has been detected.

We emphasize, in this final rule, import controls as actions to avoid the introduction of the BSE infectious agent, and epidemiological investigations as action to promptly determine the extent of introduction. However, we also place value on risk management actions that were already in place in cases where BSE is detected.

Issue:
Several commenters stated that APHIS' proposed standards for a minimal-risk region were relatively ambiguous compared to the corresponding provisions of the OIE Code. One such commenter stated this is partly because the proposal did not have an objective acceptable threshold regarding the extent of BSE infection in the country and a minimum enforcement period of effective measures, including a feed ban. Consequently, recommended the commenter, the United States should either: (1) Prepare objective guidelines that would allow exporting countries to determine their status with a certain level of predictability; or (2) investigate and approve more than one country. The commenter stated that the latter option would give other countries a much clearer idea of what is acceptable.

Response:
As explained previously, 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. Articles adopted by the OIE membership provide guidance for use by veterinary authorities, import/export services, epidemiologists and all those involved in international trade. OIE guidelines are not, however, intended to be prescriptive; each member nation may determine its own appropriate level of protection and, therefore, establish its own import requirements.

In contrast, regulations, which may be based on the OIE guidelines, are prescriptive, as they are intended to be enforced through an appropriate enforcement and compliance program. Furthermore, as rulemaking may take considerable time, the most successful regulations must also be flexible enough to allow a country to consider individual circumstances among its existing and potential trading partners, as well as advances in science, without undergoing constant revisions.

As explained previously, specific numeric recommendations in the OIE guidelines have changed over time and can be expected to change further in the future. Rigid adherence to each specific standard would disqualify some regions that present an overall minimal risk for BSE, despite not quite meeting one standard, as a result of exceeding certain other guidelines. We do not consider the suggested approach to provide a sufficient level of flexibility to allow consideration of the nature of BSE and the need to acknowledge and address varying permutations of risk among different regions on a case-by-case basis. Under the Animal Health Protection Act (AHPA) (7 U.S.C. 8301-8317), “the Secretary may prohibit or restrict the importation or entry of any animal, article, or means of conveyance * * * if the Secretary determines that the prohibition or restriction is necessary to prevent the introduction into or dissemination within the United States of any pest or disease of livestock” (7 U.S.C. 8303(a)). However, neither the AHPA nor the Secretary (or officials delegated by the Secretary) has delineated through regulations all the specific conditions that might be considered necessary to protect against the introduction of animal diseases or pests. This flexibility is necessary for APHIS to evaluate situations involving specific animal diseases or pests of concern and impose specific importation conditions necessary to mitigate the risk of the introduction of such diseases and pests.

The use of rigid criteria may limit the scope of acceptable alternatives for mitigating risk. This is particularly critical for trade-related issues. The situations in individual regions differ significantly, and each region defines its own particular spectrum of control measures. An equivalent level of risk might be reached using various combinations of different control measures. In this context, it is quite possible that a region that does not meet a particular numeric standard could compensate for any risk with other control measures. A case in point is Canada. Although Canada does not precisely meet the OIE guideline for duration of a feed ban, its control measures in other areas (such as surveillance and import restrictions) more than compensate for this. In some cases, holding a country to a rigid criterion without consideration of compensatory risk reduction measures may inappropriately discriminate against regions where the overall conditions indicate minimal BSE risk. In other cases, uniformly applying a numeric criterion without a thorough consideration of qualitative factors (
e.g.
, the quality of a country's surveillance program and the supporting veterinary infrastructure) could result in trade with a region that presents an undue risk of BSE introduction. In order to make rational decisions, APHIS needs the flexibility to make case-by-case determinations regarding the animal health status of particular regions. In fact, the OIE guidelines state that risk assessment should be flexible, in order to deal with the complexity of real-life situations. Specifically, the OIE Code states that risk assessment must be able to accommodate the variety of animal commodities, the multiple hazards that may be identified with an importation, the specificity of each disease, detection and surveillance systems, exposure scenarios, and types and amounts of data and information (Ref 19).

With regard to investigating and recognizing additional countries as BSE minimal-risk regions, that process begins with a request by the country interested in being considered, along with submission by that country of the necessary information. Several countries, in fact, submitted data in conjunction with their comments on our proposed rule. In those cases where the information exchange between the requesting country and the United States is at a very preliminary stage, it will likely be some time before we have all of the information needed and can complete our evaluation. Once an evaluation is completed, we will provide an opportunity for public comment through a proposed rule to

add the region to our list of minimal-risk regions for BSE.

Issue:
Two commenters questioned why we did not include the preparation of a risk analysis as a criterion for minimal-risk status, pointing out that a risk analysis is a basic requirement for OIE country classification for BSE under the OIE guidelines. One of these commenters said that the OIE guidelines regarding BSE minimal-risk require that a risk analysis be conducted and appropriate measures be taken to manage any risk identified. In contrast, said the commenter, instead of focusing on a region's total risk analysis process (as the OIE guideline does), APHIS focuses only on whether the region's risk mitigation strategies are adequate to prevent “widespread exposure and/or establishment of the disease.” The commenter questioned whether this approach would allow a region's potential BSE risk to be adequately assessed and addressed before the region was considered minimal-risk.

Response:
We consider an analysis of risk to be an inherent and integral component of the evaluation of a particular region with regard to BSE. Further, such an analysis is required under the WTO-SPS Agreement and the North American Free Trade Agreement. We encourage any region proposing trade to conduct such a risk analysis and include it with the documentation and data that APHIS requires. However, we did not include the preparation of a risk analysis by a region in our standards for minimal-risk status because APHIS itself intends to assess the BSE risk of a region using the criteria that were listed. APHIS routinely performs a risk analysis when proposing to allow imports, not just regarding BSE, but also with regard to other diseases of concern. A case in point is the risk analysis we prepared for this rulemaking. The standard mentioned by the commenter-whether a region's risk mitigation strategies are adequate to prevent widespread exposure and/or establishment of the disease—is only one factor that will be considered in the risk analysis. That factor itself has subsets concerning import restrictions, surveillance for BSE at levels that meet or exceed OIE guidelines, and a ban on the feeding of ruminant protein to ruminants. In addition, our risk analysis would assess whether, in regions where BSE has been detected, the region: (1) Had conducted an epidemiological investigation sufficient to confirm the adequacy of measures to prevent the further introduction or spread of BSE and (2) had taken, and was continuing to take, additional risk mitigation measures, as necessary, such as, for example, increased surveillance. With regard to Canada, our risk analysis assessed both the risk mitigation measures in place before the diagnosis of BSE in that country and the actions Canada took after the detection.

Issue:
Two commenters recommended that we provide more specificity about how APHIS would evaluate whether a region meets the criteria for minimal-risk status. One of the commenters called the proposed standards for minimal-risk regions “a series of ill-defined factors” and complained that no mechanisms for enumerating or weighing these factors were set forth in the proposal. The other commenter agreed with the approach of evaluating a region for minimal-risk status using a combined and integrated evaluation tool, rather than basing the evaluation on single-factor values such as OIE recommendations on feeding. However, the commenter suggested that how a region meets APHIS' standards should be quantitatively as well as qualitatively evaluated and that the results should be measured in terms of the relative importance to the combined and integrated overall evaluation (
e.g.
, surveillance might need to be different from the OIE recommendation and weighted more heavily than some other standards). The commenter suggested further that, in evaluating regions beyond Canada, APHIS should publish for public comment detailed risk assessments, as well as the results of the combined and integrated evaluation of the factors used to determine risk for establishing any BSE minimal-risk region.

Response:
We consider it necessary and appropriate not to specify in the regulations mechanisms for enumerating or weighing the standards for a minimal-risk region. As discussed above under the heading “More Focused Regulatory Restrictions,” holding a country to a rigid criterion without consideration of compensatory risk reduction measures may, in some cases, unfairly discriminate against regions where the overall conditions indicate equivalence with minimal BSE risk. In other cases, uniformly applying a numeric criterion without a thorough consideration of qualitative factors (
e.g.
, the quality of a country's surveillance program and the supporting veterinary infrastructure) could result in trade with a region that presents an undue risk of BSE introduction.

Application of Standards to Other Countries

Issue:
A number of commenters raised questions regarding how the proposed standards for BSE minimal-risk regions would be applied to countries other than Canada. Some commenters stated it appeared the standards were tailored to meet the situation in Canada. Several commenters proposed additional countries for classification as BSE minimal risk and suggested that those countries be included in this rulemaking. One commenter requested that APHIS publish for public comment evaluations done for regions beyond Canada. One commenter recommended that applications for BSE minimal-risk recognition from regions with similar status as Canada be rejected. Conversely, another commenter recommended that any countries that currently have standards that equal or exceed those of Canada should be included as BSE minimal-risk regions in this final rule.

Response:
We stated in our proposed rule that we would consider requests from other countries for recognition as minimal-risk regions once the regulatory framework defining a BSE minimal-risk region had been established through this rulemaking. We will evaluate other countries using the same standards we used for evaluating Canada. Countries wishing to be recognized as minimal-risk regions by APHIS need to apply for such recognition by following the procedures set forth in 9 CFR part 92, “Importation of Animals and Animal Products: Procedures for Requesting Recognition of Regions.” Although the 11 factors listed in part 92 are not the same as the standards listed in this rule for BSE minimal-risk regions, they are broadly applicable to any change in disease status and are compatible with the BSE minimal-risk standards in this rule. As noted above, several countries submitted data in conjunction with their comments on our proposed rule. Once all of the necessary information is received, we will conduct an evaluation of the request and, if a proposal appears warranted, provide an opportunity for public comment through a proposed rule to add the region to our list of minimal-risk regions for BSE. A final rule based on the proposed rule would need to be issued before imports could begin.

Issue:
One of the standards for minimal-risk status was that a region in which BSE has been detected must have had in place, prior to the detection of BSE in the region, risk mitigation measures adequate to prevent widespread exposure to and/or establishment of the disease. Several commenters asked how, according to that criterion, countries that reported cases of BSE before scientific studies had determined appropriate risk

mitigation requirements would be able to be considered BSE minimal-risk regions.

Response:
We agree that countries that were among the first to diagnose BSE will, under the standards in this rule, not qualify as BSE minimal-risk regions. Because of the lengthy incubation period of the disease, by the time BSE was diagnosed in such countries and control measures were implemented, the chances that the disease had significantly spread were great. However, individual regions may apply to APHIS to be able to export to the United States specific products under conditions that could differ from those in our current regulations. Such applications should be submitted in accordance with 9 CFR part 92 and will be considered when received by APHIS.

Measures to Prevent Widespread Exposure or Establishment

Issue:
In our proposed definition of
BSE minimal-risk region
in § 94.0, we provided that such a region must maintain, and, in the case of regions where BSE was detected, must have had in place prior to the detection of BSE, risk mitigation measures adequate to prevent widespread exposure and/or establishment of the disease. One commenter asked the following questions: (1) What exactly are the risks to be addressed and mitigated by the country seeking minimal-risk status; (2) what risk mitigation measures are deemed adequate; and (3) what are the standards to be used to judge whether the measures are adequate?

Response:
As discussed in the preamble to our proposed rule, in evaluating whether a country had in a place risk mitigation measures adequate to prevent widespread exposure or establishment of BSE, we would consider whether the country had in place:

• 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 OIE recommendations 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 infectious agent, with no evidence of significant noncompliance with the ban.

We provided, further, that, in regions where BSE was detected, a minimal-risk region must have 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 must continue to take such measures. Additionally, the region must have taken additional risk mitigation measures, as necessary, following the BSE outbreak based on risk analysis of the outbreak, and continue to take such measures.

We did not specify numeric thresholds for each of the above criteria. As discussed above, 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. Further, in some cases, holding a country to a rigid criterion without consideration of compensatory risk reduction measures may not be scientifically justified and may unfairly discriminate against regions where the overall conditions indicate 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 numeric criteria but, nonetheless, present, in our view, an undue risk of BSE introduction. Therefore, 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.

Issue:
As noted above, one of the proposed standards for a BSE minimal-risk region was that, in regions where BSE was detected, the region “had in place prior to the detection of BSE, risk mitigation measures adequate to prevent widespread exposure and/or establishment of the disease.” One commenter asked for clarification of the meaning of “widespread exposure or establishment,” of whether moderate exposure or establishment is acceptable, and of how many cases are acceptable in both humans and animals. Another commenter stated that the wording in the definition could create disagreements with regions applying for BSE minimal-risk status as to whether the disease is widespread in a particular region.

Response:
APHIS has set no specific thresholds for an acceptable number of cases in humans or animals. Rather, the Agency will conduct an evaluation of the BSE situation in a region according to the factors in that region and define mitigations appropriate for the conditions. APHIS would consider in its evaluations OIE recommendations regarding the recommended maximum number of BSE cases per million at different BSE risk levels.

As an example, APHIS considers the situation that existed in the United Kingdom and certain other European countries in the 1990s to be clearly an example of widespread exposure or establishment, and also one that would clearly contribute to a high-risk categorization under OIE guidelines (Ref 1). Widespread BSE exposure in the United Kingdom was at its peak in the early 1990's, as reflected by the finding of more than 30,000 cases per year in 1992-1993. The situation has improved dramatically with the stringent control measures that have been imposed in the United Kingdom. This has also been the case in other European countries that have had what we consider “widespread exposure.” It is important to note that, in each of these situations, BSE was detected and control measures were then instituted, resulting in some delay until the effects of the control measures could become apparent. These situations were very different, for example, from the situation in Canada, where: (1) Control measures were in place before the detection of the disease; (2) only two animals of Canadian origin have been confirmed with BSE; (3) both were born before implementation of Canada's feed ban; and (4) Canada has maintained other protective measures (including import restrictions) that would help preclude a significant level of infectivity from being transmitted to the cattle population.

Surveillance

Issue:
One commenter stated that the premise in the proposed rule that prevalence of BSE will be lower in regions with adequate prevention and control measures does not take into account that the level of determined prevalence is dependent on the quality and level of surveillance in each region. The commenter expressed concern that, although a country may say it has low prevalence, its surveillance may be inadequate to accurately measure the prevalence.

Response:
We agree with the commenter concerning the importance of a valid and effective surveillance program. One of the first evaluations we make regarding a country or other region seeking a particular animal health status is the effectiveness and

reliability of its veterinary infrastructure, including its surveillance programs.

Issue:
One commenter recommended that the specific content of adequate surveillance systems be detailed in the regulations.

Response:
In this rulemaking, we require that a region seeking BSE minimal-risk status conduct surveillance for BSE at levels that meet or exceed OIE recommendations for surveillance for the disease. As noted above, in establishing its guidelines, 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. Therefore, the OIE guidelines are constantly evolving and subject to change. In order to make our regulations flexible enough to allow us to accommodate internationally recognized changes in science without making constant revisions to the regulations, we are basing our requirements for surveillance on OIE recommendations, but are not specifying numeric thresholds in this rule.

Feed Restrictions

Issue:
One of the standards we proposed for a BSE minimal-risk was that the region have “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.” Several commenters took issue with this factor. The commenters stated that the absence of evidence of noncompliance is not evidence of compliance and that this standard could be met by countries with no or minimal compliance monitoring. The commenters stated that the feed ban should be enforced by an inspection program, including sampling and testing of feed, as recommended by the IRT. Another commenter took issue with the words “appears to be,” recommending instead that the factor should address whether a feed ban is or is not an effective barrier in a particular region. One commenter stated that specific guidelines for compliance, including on-farm compliance, should be provided.

Response:
We concur that the lack of evidence of noncompliance may not be evidence of compliance. We did not intend for the proposed rule to produce or allow for the result described by the commenter. For this reason, we are changing the wording of the factor referred to by the commenter to provide instead that “a ruminant-to-ruminant feed ban is in place and effectively enforced.” It was, and continues to be, our intent to evaluate all relevant factors thoroughly. Determining whether a feed ban has been effectively enforced will involve a review by APHIS of a number of interrelated factors, including: The existence of a program to gather compliance information and statistics; whether appropriate regulations are in place in the region; the adequacy of enforcement activities (e.g., whether sufficient resources and commitment is dedicated to enforcing compliance); a high level of facility inspections and compliance; accountability of both inspectors and inspected facilities; and adequate recordkeeping. Our individual evaluation of the BSE status of a region will assess these factors and evaluate any contribution to risk.

Issue:
Several commenters expressed concern regarding a U.S. recommendation to the OIE that the OIE feed ban duration standard be reduced from 8 to 5 years. One commenter recommended that USDA champion a continuation of the current OIE standard. Commenters stated that shortening the standard from an 8-year feed ban was inadvisable because it is possible some residual ruminant protein feed in some countries would be fed for several years after a feed ban went into effect.

Response:
The APHIS recommendation that the OIE standard for the minimum duration of a feed ban be reduced from 8 years to 5 years was based on the estimated average incubation period of the BSE agent in cattle. As discussed above, the Harvard-Tuskegee Study (Ref 17) estimates that the variability distribution for the BSE incubation period in cattle has a median (50th percentile) of approximately 4 years. Based on the best-fit parameter values provided in the Harvard-Tuskegee Study (Ref 18), the mean (expected value) of the incubation period distribution is estimated at 4.2 years. However, the OIE decided not to change the standard.

Epidemiological Investigation

Issue:
A commenter expressed concern with the proposed factor for a BSE minimal-risk region related to an epidemiological investigation. This factor stated that, in regions where BSE has been detected, a minimal-risk region must have “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.” The commenter stated that the standard focuses on the conduct of an investigation and not whether there were definitive findings resulting from such an investigation. The commenter also took issue with our explanation in the preamble that “an investigation following a detected case would include, among other things, an investigation to determine the most likely source of the animal's exposure to BSE,” saying that the “most likely source” is not a definitive finding.

Response:
Certainly, the quality of the investigation and its results and findings must be carefully evaluated. However, definitive findings are not always possible or necessary in an epidemiological or scientific investigation. If a region is able to explain the approach it has taken in its investigation and produce adequate information regarding the most likely source of infection, the lack of a definitive finding can be within normal scientific parameters. Uncertainty may, in many instances, be compensated for in other areas, such as through appropriate mitigations. Depending on the quality of the epidemiological investigation, the absence of definitive findings may be less important than whether there are adequate measures in place to address disease risk.

Additional Measures

Issue:
One commenter expressed concern with the proposed factor for a BSE minimal-risk region that requires that, in regions where BSE was detected, the minimal-risk region “took additional measures, as necessary, following the BSE outbreak based on risk analysis of the outbreak, and continues to take such measures.” The commenter objected to our explanation in the preamble that additional risk mitigation measures could include “a broad eradication program, increased surveillance, or additional import restrictions,” expressing concern that the statement indicates that additional measures either could or could not include those listed by APHIS.

Response:
We intended the additional mitigation measures that were listed by the commenter (a broad eradication program, increased surveillance, and additional import restrictions) to be examples of possible additional measures that might be necessary. In pointing to those measures, we did not intend to provide a definitive list of additional mitigation measures we might consider; rather, the examples were intended to provide a sense of the types of measures we might consider. Indeed, in the discussion of OIE standards in the updated risk analysis,

we provide several more examples of additional mitigation measures we are considering, e.g., an ongoing awareness program for veterinarians, farmers, and workers involved in transportation, marketing, and slaughter of cattle; compulsory notification and investigation of all suspected cases of BSE; and examination in an approved laboratory of brain and other tissues collected within the framework of the surveillance and monitoring system. As we stated in the preamble of our proposal, measures will be required that are appropriate depending on the conclusions of the risk analysis that is required following a BSE diagnosis.

Human Health Risks

Issue:
Several commenters recommended that the definition of
BSE minimal-risk region
specifically list actions taken to minimize human health risks, which the commenter said should be equal to or more stringent than those in the United States. The commenters stated that the definition should require, for example, that minimal-risk regions do the following: (1) Ban use of non-ambulatory cattle; (2) hold product/carcass until negative results are obtained; (3) prohibit air-injected stunning; (4) remove high-risk tissues; and (5) prevent the inclusion of central nervous system tissue in “meat” products.

Response:
The issues raised by the commenters relate to the equivalency of standards for the production of meat in countries that export to the United States. The FSIS regulations in 9 CFR 327.2 provide that, to be eligible to export meat and meat products to the United States, a foreign country must be able to certify that it applies to its own meat processing establishments requirements equivalent to those in the United States. Under those regulations, exporting countries are required to provide documentation supporting how their meat inspection system is equivalent to that of the United States. FSIS determines whether the systems are equivalent. The FSIS procedures for evaluating such equivalency are discussed below in more detail, under the heading “Verification of Compliance in the Exporting Region.” Each of the requirements recommended by the commenter are currently required of meat processing establishments in the United States and, therefore, are applicable to establishments in foreign countries that wish to export meat and meat products to the United States.

Tracking and Labeling

Issue:
One commenter recommended that requirements for a minimal-risk region include existence of a national animal identification and tracking program, adequate and active testing and monitoring programs for all OIE List A animal diseases, and product labeling to enable tracking of the product.

Response:
Although the standards for a BSE minimal-risk region in this rule do not specifically require a national animal identification and tracking program, they do include a requirement for an effective epidemiological investigation and the ability of authorities in the region to conduct traceback and trace-forward of animal feed or rendered material. An evaluation of these capabilities will include consideration of animal identification. Although we acknowledge the importance of adequate testing and monitoring for OIE List A diseases with regard to whether and under what conditions animals and animal products should be allowed importation from a particular region, those diseases are already addressed individually in the regulations in 9 CFR 92, 93, 94, 95, 96, and 98. Further, we do not consider List A diseases to fall under the scope of this rulemaking. List A diseases are defined by OIE as transmissible diseases that: (1) Have the potential for very serious and rapid spread, irrespective of national borders; (2) are of serious socioeconomic and/or public health consequences; and (3) are of major importance in the international trade of animals and animal products. BSE is not included as an OIE List A disease but, instead, is categorized as a List B disease. List B diseases are considered to be (1) of socioeconomic and/or public health importance within countries and (2) significant in the international trade of animals and animal products.

With regard to product labeling in the exporting region, it is not clear to us from the comment what type of labeling the commenter is referring to.

Testing of Ruminants

Issue:
One commenter stated that, if BSE is diagnosed in a country, the United States should not accept ruminants and ruminant products from that country until the country tests all cattle over 20 months of age at slaughter. Other comments recommended that we require that all cattle slaughtered in such a country be tested for BSE. Some commenters recommended that such testing be carried out by USDA representatives in Canada.

Response:
We understand the interest expressed by some commenters in testing certain cattle for slaughter. However, no live animal tests exist for BSE and the currently available postmortem tests, although useful for disease surveillance (i.e., in determining the rate of disease in the cattle population), are not appropriate as food safety indicators. We know that the earliest point at which current testing methods can detect a positive case of BSE is 2 to 3 months before the animal begins to demonstrate clinical signs. We also know that the incubation period for this disease—the time between initial infection and the manifestation of clinical signs—is generally very long, on the average of about 5 years. Accordingly, we know there is a long period during which, using the current methodology, testing an infected animal that has not demonstrated clinical signs of the disease would, incorrectly, produce negative results. If, however, the infected animal is already exhibiting some type of clinical signs that could be consistent with BSE, then the test is not likely to produce false negative results.

Development of reliable food safety indicators will require improved understanding of the pathogenesis of the disease and improved laboratory methods. However, if BSE is present in a country's cattle population, various mitigation measures, such as feed bans and removal of SRMs, are available to prevent the spread of BSE in cattle and to prevent human exposure to the BSE agent. The United States and Canada have already implemented such measures. The results of an enhanced animal surveillance program for BSE, announced by the Secretary on March 15, 2004 (Ref 20), and currently underway, which will help determine the prevalence of BSE in the United States, should the disease exist, and will provide information that will indicate whether these measures should be adjusted. But measures such as SRM removal and the prohibition of the use of non-ambulatory cattle in human food will ensure a safe meat supply. Testing of individual animals, especially if it is performed on clinically normal animals at slaughter, is not in itself an effective risk mitigation measure for protecting public health. The purpose of a surveillance program is to gauge the level of BSE prevalence. This can be achieved through targeted sampling, as is being carried out in the United States and Canada.

For these reasons, we do not consider the testing at slaughter of every bovine over 20 months of age, or the testing of every bovine at slaughter, to be scientifically justified or meaningful in the context of either human or animal health. Making this a criterion for minimal-risk regions would not contribute to human or animal health protection beyond the protection

achieved by a statistically and epidemiologically valid surveillance plan, coupled with the risk mitigations specified in this rule.

B. Recognition of Canada as a Minimal Risk Region

Issue:
A number of commenters questioned whether Canada has made improvements to its systems (
e.g.
, surveillance infrastructure, surveillance levels, removal of SRMs, feed ban compliance) sufficient to warrant the resumption of exports of ruminants and ruminant products to the United States. Other commenters contended that Canada has not effectively enforced its feed ban and that further investigation and enforcement is necessary.

Response:
Enhancements Canada has made to its surveillance levels are discussed above in section III. B. under the heading “Additional Measures Taken in Canada” (Ref 16). Additionally, Canada has added a rapid test as a routine screening tool and has expanded the number of laboratories approved to run BSE tests. These steps should shorten the interval between collection of samples and diagnosis. In July 2003, the Canadian Government issued requirements for the removal, identification, control, and disposition of SRMs (Ref 15). The Canadian SRM requirements for products eligible for importation into the United States are equivalent to requirements in the United States.

Based on the information available to us, including communication with and visits to Canada, we have concluded that Canada has effectively enforced its feed ban. Canada implemented a feed ban in 1997 that prohibits the feeding of most mammalian protein to ruminants. The Canadian feed ban is essentially the same as the feed ban in place in the United States. Canadian Government authorities inspect rendering facilities, feed manufacturers, and feed retailers to ensure compliance with the feed ban. Procedures to reduce the likelihood of cross-contamination are in place at all feed mills that handle both prohibited and nonprohibited feeds. As discussed below under the heading “Prevalence of BSE in Canada,” CFIA indicates that compliance with the feed ban is very high.

Issue:
Several commenters expressed concern about the 4 months that passed between the death of the BSE-infected Canadian cow in January 2003 and the diagnosis of BSE in May 2003. The commenters stated that this delay in diagnosis indicates that disease surveillance and laboratory disease diagnostic capabilities in Canada are not equal to those in the United States.

Response:
It is true that the May 2003 case of BSE in Canada was not confirmed until 4 months after the death of the animal. This delay was due to a combination of factors, primarily the fact that the sample was not identified as “suspect” for BSE. Samples were taken from the cow at slaughter because it was non-ambulatory. The animal passed ante-mortem inspection but was condemned on post-mortem inspection for pneumonia. Because the cow did not display classic clinical signs of BSE, samples were tested as they would be for any routine surveillance sample. Also, because the sample was identified as part of routine surveillance, the laboratory did not place a high priority on it for testing. In order to address the delay, Canada has changed its surveillance approach, primarily by using rapid screening tests for BSE. We consider BSE surveillance and diagnostic capabilities in Canada to be equivalent to and as effective as those in the United States.

Issue:
One of the standards we proposed for qualification as a BSE minimal-risk region was that a region conduct surveillance for BSE at levels that meet or exceed OIE guidelines. One commenter objected to that standard with regard to Canada, stating OIE surveillance recommendations are intended for countries that have not diagnosed a case of BSE in native cattle. A number of commenters stated that Canada should not be considered a BSE minimal-risk region until that country increases its surveillance levels for BSE, so that the disease situation in Canada is better understood. Some commenters raised concerns that Canada's proposed level of testing was much lower than what the United States has proposed for U.S. testing. One commenter recommended that a surveillance program test all high-risk cattle in Canada during a period of at least 12 to 18 months.

Response:
The commenter's suggestion that OIE surveillance recommendations are intended for countries that have not diagnosed a case of BSE in native cattle is incorrect. The OIE testing guidelines apply to any country or zone, whether or not BSE has been diagnosed in a native animal. As discussed above, 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 ex

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A04-28593. Public record. Not legal advice.