Canada Gazette

Bovine spongiform encephalopathy (BSE, commonly referred to as mad cow disease) is a fatal disease in cattle which causes degeneration of the central nervous system, resulting in the formation of sponge-like holes in the brain. It is part of a group of diseases known as transmissible spongiform encephalopathies (TSEs), such as scrapie in sheep, chronic wasting disease in deer and elk and variant Creutzfeldt-Jakob Disease in humans. Research on BSE is incomplete, but this disease has been associated with the presence of an abnormal prion protein and, to date, there is no effective treatment or vaccine.

Bovine spongiform encephalopathy was first confirmed by neuropathological examination of a bovine brain in southern England in December 1986. The first clinical case (also in England) in April 1985, was not confirmed histologically. Following that initial diagnosis, there was a rapid rise in the prevalence of clinical BSE cases in the U.K. The annual number of confirmed BSE cases peaked at 37 280 in 1992 according to the World Organization for Animal Health (OIE). Since then, the annual number of confirmed BSE cases in the U.K. has declined every year.

Clinical signs of BSE in cattle include changes in sensation and behaviour, with altered mental status, posture and locomotion. However, definitive diagnosis is made by post-mortem histological examination of the brain, with immunohistochemistry and/or Western blot of samples from the brainstem (obex) currently the most sensitive and specific diagnostic tests. At this time there is no test available to diagnose BSE in the live animal.

BSE is not considered to be a contagious disease; there is no evidence to date of horizontal transmission between cattle. Although maternal transmission is postulated by many authorities to occur, an interval estimate for the probability of transmission from the dam to calf, when the dam is infected and in the last six months of the incubation period, occurs at a rate of 1 percent to 10 percent. Species known to have contracted a form of the disease from consumption of BSE-infected tissues include cattle, humans, felines, captive zoo primates and zoo ungulates. And although meat-and-bone meal contaminated with BSE may have been fed to sheep, goats, water buffalo, bison, cervids and camelids before implementation of the ruminant protein feed bans in many countries, there is, to date, no conclusive evidence of BSE in any of these species in livestock production.

Tissue infectivity studies have determined that the highest infectivity in cattle is confined to the central nervous system of clinically affected animals, including the brain, spinal cord and retina, with distribution of infectivity in tissues progressing from the lymphoreticular system during the early stages to the peripheral nervous system, and finally the central nervous system during the late stages of incubation. Infectivity has been detected in the distal ileum, parts of the brain, spinal cord and spinal ganglia from as early as three months before the onset of clinical signs, and other tissues may carry infectivity before it is detected in the central nervous system. This has been the rationale for the removal of certain tissues (which vary from country to country and between ruminant species) known as specified risk material (SRM) carcasses at slaughter. In cattle, SRM includes skull, vertebral column and dorsal root ganglia, brain, spinal cord, eye, tonsils, lymph nodes, spleen and intestines. These tissues are reported to account for up to 99 percent of the BSE infectivity.

BSE and variant Creutzfeldt-Jakob disease (vCJD) are members of a family of diseases called transmissible spongiform encephalopathies, or TSEs. These diseases, which occur in humans and some other animal species, are progressive, fatal neurodegenerative diseases. TSEs are characterized in the brain by the presence of microscopic vacuoles (spongiform changes), the deposition of amyloid (prion) protein in the grey matter, and the appearance of unique fibrils called scrapie-associated fibrils. TSEs have long incubation periods, and clinical disease is most often observed in adults, culminating in various physical and mental abnormalities that precede death. There is no known treatment or prophylaxis.

These diseases, some of which are believed to have existed for centuries, include human varieties Creutzfeldt-Jakob disease (sporadic, iatrogenic, familial and variant forms), kuru, Gerstmann-Staussler-Scheinker syndrome, and fatal familial insomnia, as well as scrapie in sheep, transmissible mink encephalopathy, chronic wasting disease of deer and elk, feline spongiform encephalopathy and bovine spongiform encephalopathy.

The aetiology of TSEs is a source of much debate; the actual disease-causing agent remains unknown. It is now believed, however, that the disease agent is associated with an abnormal isoform (designated PrP-res) of a normal cell-membrane-associated protein (designated PrP-sen) called a prion, which becomes abnormally folded and goes on to recruit further normal prion molecules to become misfolded (normal prion proteins occur in all animals, including humans). The abnormal proteins mainly accumulate in the central nervous system, and by some yet-to-be-understood mechanism induce cell death, causing the characteristic brain vacuolation seen histologically. The agents causing TSEs are hydrophobic, lipophilic, biologically stable and extremely resistant to those inactivation processes used commonly for other infectious microorganisms such as bacteria, fungi and viruses. They are unique in that they do not appear to induce an immune response in the host. TSEs may be acquired by inherited genetic mutations of the PrP gene that codes for the prion protein. They may also arise spontaneously in an individual, with no apparent cause.

Although the prevailing theory is that TSEs are associated with abnormal prion protein, there remain a number of alternative theories regarding the cause of these diseases, including the organophosphate theory, the autoimmune theory, and the theory that prion diseases are linked to metal-ion imbalances in foodstuffs.

Variant Creutzfeldt-Jakob disease was first diagnosed in humans in the United Kingdom in 1996. There has been one vCJD case reported in Canada. That patient had lived in the U.K. during the peak years of the BSE epidemic in that country, and the evidence suggests that the disease was acquired prior to residency in Canada.

The invariably fatal disease in humans is characterized by progressive degeneration of the central nervous system, and has been experimentally proven to be caused by the same agent that causes BSE in cattle. Clinically, vCJD varies in its manifestation from other TSEs in humans in that it strikes individuals at a much younger age. The average age of the onset is 29 years (range 12 to 74), and the average age at death 29 years, with patients living for an average of 14 months once they show clinical symptoms. The median age for classic Creutzfeldt-Jakob Disease (CJD) is 65 years.

The pathogenesis of vCJD differs considerably from that of other forms of CJD in humans, particularly in that the abnormal prion protein, PrP-res, is found in lymphoreticular tissues in vCJD cases but not in other forms of CJD. The generally held hypothesis is that the current vCJD epidemic is the result of dietary exposure—the consumption of ruminant products containing tissues with BSE. Current scientific research, including results from epidemiological studies showing weak statistical support for a causal association for BSE transmission from cattle to humans through human consumption of contaminated bovine products, has not conclusively proven that vCJD is caused by eating specific contaminated food products.

There has been considerable speculation regarding the extent of the vCJD epidemic, with some investigators denying that there is, in fact, an epidemic. Estimates of the numbers of cases that will be seen in the next few years or more range from hundreds of individuals to tens or hundreds of thousands. Even using computer simulation studies, it has been difficult to calculate the size, shape and dynamics of the epidemic curve due to the paucity of data available. A retrospective study in the U.K. testing tonsil and appendix samples collected at autopsy or surgery reported a predicted prevalence rate of 120 per million among people aged 10 to 50 years.

Many scientific uncertainties still exist about BSE and its causative agent, and these are being rigorously addressed in the scientific community, particularly since the 1996 confirmation of vCJD in humans and its link to BSE. Both experimental and epidemiological evidence now indicate that vCJD is caused by the BSE agent, and although the oral route of exposure seems most likely for transmission to cattle and humans, many questions remain regarding other routes of exposure, infective dose, relative infectivity of tissues, genetic susceptibility, accumulated infectivity and species barriers. As of June 2004, there have been 159 definite or probable cases of vCJD diagnosed: 147 in the United Kingdom; 7 in France; 1 in Canada; 1 in Hong Kong; 1 in Ireland; 1 in Italy; and 1 in the United States of America.

Canada implemented a surveillance program for BSE in 1992 that tests a sample of animals from the national cattle herd. Tests focus on higher-risk animals, which are most likely to be affected by the disease. The surveillance program's objectives are to determine and monitor the level of BSE present in Canada and to measure the effectiveness of other measures Canada has implemented to mitigate the risk of BSE in the national herd. More details can be found on the Canadian Food Inspection Agency's (CFIA) Web document entitled "Surveillance and Animal Tracking" at www.inspection. gc.ca/english/anima/heasan/disemala/bseesb/surv/protecte.shtml (or a copy is available upon request).

The incorporation of rendered protein from cattle infected with BSE and sheep with scrapie into cattle feed is considered the primary means by which the BSE epidemic spread in the United Kingdom (U.K.). The export of infected cattle and feed from the U.K. to Europe is also thought to have been responsible for the introduction of BSE to other European countries such as Switzerland, France, Italy and others.

The practice of rendering ruminant by-products into proteins and fats and incorporating them as ingredients in ruminant feed is therefore a known risk factor that could contribute to the spread of BSE. As this practice is also considered a public health issue, the World Health Organization (WHO) requested that it be abolished worldwide.

As a secondary measure, the Government of Canada implemented a mammalian-to-ruminant feeding ban (with exceptions) in 1997 by amending and adding provisions to the federal Health of Animals Regulations. At the time, Canada was thought to be BSE-free. The primary BSE prevention measures employed were the use of strict import controls, starting in the early 1990s, on animals, animal products and by-products from countries which posed a risk of having and transmitting BSE. The feed ban was implemented in accordance with a World Health Organization (WHO) recommendation in 1996 that all countries ban the feeding of ruminants with meat and bone meal (MBM) derived from other ruminants to help check the spread of BSE. The purpose of the federal Health of Animals Regulations are to prevent the introduction of animal diseases into Canada and to control and eliminate diseases in Canada that either affect human or animal health or could have a significant economic effect if they entered Canada.

Canada's present ban prohibits the feeding of ruminant animals (cattle, sheep, goats, deer, elk and other species) with most proteins derived from mammals (excluding proteins derived from solely swine and equines as well as milk, gelatin, animal fat and blood products from all species). The regulatory framework of the existing feed ban requires manufacturers, users, vendors and feeders of animal proteins and feeds to have procedures and records in place to demonstrate that

• segregation of prohibited animal proteins is maintained to prevent feeding to ruminants and the adulteration or cross-contamination of ruminant feeds;

• labels of products comprising or containing prohibited proteins carry warnings about not feeding them to ruminants; and

• records of distribution for proteins and feeds are being kept to facilitate tracing throughout the animal feed and animal production chain.

Because of the nature of the ban, the testing of ruminant feeds for compliance with the ban (i.e. to check for the absence of prohibited proteins) has not been possible due to limitations of the methodologies available. As a result, the CFIA, the national organization responsible for administering the Health of Animals Act, has verified compliance with the existing ban requirements since 1997 by way of inspection activities at the following types of establishments along the animal food production and use chain:

In May 2003, as part of Canada's national active, targeted surveillance program for BSE, the provincial government in Alberta tested a cow that had been condemned at slaughter and found not suitable for human consumption. This cow subsequently tested positive for BSE and was considered to be sentinel for the presence of BSE in North America more generally. In December 2003, an additional case of BSE was detected in a cow in Washington State in the United States. The investigation that followed determined that the cow had been born and raised for a few years in Canada before being exported to the United States.

Following the detection of the index BSE case in May 2003, the CFIA conducted a comprehensive epidemiological investigation. A summary report, "Summary of the Report of the Investigation of Bovine Spongiform Encephalopathy (BSE) in Alberta, Canada," can be found on the CFIA Web site at www. inspection.gc.ca/english/anima/heasan/disemala/ bseesb/ evalsume. shtml or a copy is available upon request. The investigation concluded that the incidence of BSE is very low, in part because Canada introduced its feed ban in 1997.

Although the infected cow was not processed for use in human food, its remains were collected and processed into meat and bone meal along with other animal by-products at a commercial rendering facility. As a result, one of the components of the CFIA's investigation was to conduct a "feed trace forward" to determine where the MBM thought to have contained the remains of this cow may have gone. A diagram of this part of the investigation, "BSE Tracing Investigation – Feed Trace Forward," can be found at www.inspection.gc.ca/english/anima/heasan/disemala/bseesb/ invest/20030616feebete.shtml or a copy is available upon request.

The remains of the BSE-infected cow were traced through their distribution into pet food and animal feed. As many as 1 800 farms (600 recipients of bulk feed and 1 200 recipients of bagged feed) may have received animal feed containing some or all of the MBM (approximately 80 kg) obtained from the infected cow. Inspections undertaken by the CFIA confirmed that the renderer and the feed mills had good records of compliance with the feed ban. Notwithstanding the fact that the feeding to cattle and other ruminants of products containing ruminant origin MBM is prohibited, the CFIA conducted on-farm inspections on a representative sample of (200) farms to evaluate the risk of ruminant exposure to the contaminated feed. Based on these investigations, the CFIA concluded that 99 percent of farms experienced no (96 percent) or incidental (3 percent) exposure to potentially contaminated feed. On 1 percent of the farms inspected, ruminants may exceptionally have been exposed to feed containing prohibited material. Three farms were quarantined and 63 cattle that may have eaten poultry feed were destroyed. Taking into account the very small probability of exposure of ruminants on the remaining farms, and impending enhancements to BSE risk management, no additional measures were imposed on the other farms. This decision was consistent with the recommendations of the international scientific experts who reviewed the CFIA's investigation.

Based on the findings of the comprehensive investigation and the one conducted following the December 2003 Washington State case, it was concluded that

• BSE was likely introduced into Canada by one or a few imported U.K. cattle that died or were slaughtered and whose by-products were subsequently rendered and used in feeds for cattle prior to the 1993/94 cull of remaining imported U.K. animals;

• BSE infectivity was present in Canada's feed supply before the feed ban was implemented, as the two North American cases were born in the spring of 1997 just months prior to the ban coming into effect in both Canada and the United States;

• contaminated feed was likely present in commerce for a short period after the feed ban went into effect, as a grace period was provided to allow feeds in the marketplace manufactured pre-ban to clear the system; and

• as a result, there is a potential that additional BSE cases in cattle could be detected in a small number of animals born either before the feed ban or during a limited time thereafter.

There are a number of compelling reasons to conclude that the incidence of BSE in Canada is equivalent to that of a minimal risk country as defined by the OIE in their Terrestrial Animal Health Code. The OIE criteria for a minimal risk country is comparable to the extensive risk mitigation measures that have been implemented in Canada for BSE over the last two decades as well as the response to the detection of BSE. Despite increased surveillance, only one case of BSE has been detected domestically since May 2003. The incidence of BSE cases in Canada remains below one in a million. Over time, further increases in surveillance for BSE in cattle in Canada will provide a basis for better estimating the true incidence of BSE in Canada. However, this information is still several years away.

With the detection of BSE in Canada, the feed ban now assumes a primary role in eliminating BSE by preventing further spread of the disease to other cattle. In analyzing the existing feed ban regulatory framework, any potential BSE infectivity entering the animal food supply requires the management of infectivity throughout the entire feed and animal production chain. The current framework provides opportunities for prohibited proteins to be accidentally included in or cross-contaminate feeds for ruminants. When the feed ban was implemented in 1997, it was believed that 1 g of infected cattle by-product material could cause the infection of another bovine. Measures to prevent cross-contamination are even more critical as it is now believed that as little as 0.001 g (1 mg) of infected material can transmit the disease. However, without the availability of definitive testing methods, assessing non-compliance and the effectiveness of the ban remains difficult. Furthermore, as the investigation demonstrated, opportunities for misuse of feed on farms with multiple species represent an area of vulnerability within the framework of the current ban. Consequently, the impacts of non-compliance along the production chain would serve to reduce the ban's effectiveness. Based on the above analysis, the Government is of the view that augmentations to the current feed ban framework are warranted.

The present feed ban, implemented without benefit of additional resources, might have been acceptable without the incidence of BSE in the country; but with it, there is a need to strengthen the key points crucial to preventing spread of the disease. This is consistent with the OIE and with international expectations. No other country has become BSE-positive without introducing additional feed controls measures. Most other countries that have become BSE-positive have implemented a complete animal protein feeding ban. However, the international community recognizes Canada's control measure to date and thus should accept a less restrictive feed ban, specifically the removal of potentially infective tissues, referred to as SRM.

Following the detection of BSE in Alberta in May 2003, an international team of animal health experts were invited to review the Canadian BSE situation. Among several recommendations made to the Government of Canada, the team strongly endorsed the removal and redirection of cattle SRM from the human food and the animal feed chain. SRM are tissues that, in infected cattle, harbour the BSE agent. The review team stressed the importance of preventing opportunities for cross-contamination or cross-feeding of ruminants with prohibited proteins but was not prescriptive regarding how best to accomplish this objective. The report, "Report on Actions Taken by Canada in Response to the Confirmation of an Indigenous Case of BSE," can be found at www.inspection.gc.ca/english/anima/heasan/disemala/bseesb/ internate.shtml or a copy is available upon request. A similar recommendation was made by the team in February 2004 in reviewing the U.S. BSE experience with the infected cow detected in Washington State.

The Government of Canada has already responded to the finding of BSE domestically by implementing several new or enhanced measures with respect to human food safety, animal traceability, BSE surveillance in the cattle population and others. Most notably, the Government amended the federal Food and Drug Regulations and the Health of Animals Regulations to ban SRM from human food in July 2003. This was the single most important step that could be taken to protect public health. In these regulations, the list of tissues defined as SRM that are required to be removed from the human food supply are as follows:

(a) the skull, brain, trigeminal ganglia, eyes, tonsils, spinal cord (in practice, the vertebral column) and dorsal root ganglia of cattle aged 30 months or older; and

(b) the distal ileum (in practice, the entire small intestine) of cattle of all ages.

With respect to augmenting the feed ban regulatory framework, on July 9, 2004, the Government announced that it would introduce new animal feed restrictions to further strengthen Canada's safeguards against BSE. In keeping with the findings of its own analysis and the recommendations of the international team, the Government is proposing amendments to require the removal of SRM from the animal feed chain.

It is proposed that the existing framework of the 1997 feed ban (outlined above) will be maintained in the Health of Animals Regulations and would be enhanced by the addition of the following requirements:

• prohibiting the use of proteins derived from cattle SRM, condemned and dead stock cattle and other ruminants in animal food, including pet food, and in fertilizers; in BSE-infected cattle, SRM harbour the BSE agent. The dead stock or condemned carcasses of cattle may also harbour the agent. Furthermore, other ruminant dead stock or condemned animals may also harbour other transmissible spongiform encephalopathy (TSE) diseases (scrapie in sheep and chronic wasting disease in deer and elk) which are also indigenous in Canada. By extending these prohibitions to pet foods, any potential exposure of companion animals or their owners to these agents would also be eliminated;

• the segregation of SRM being removed at slaughter or during further processing of other cattle tissues and the dedication of equipment that handles SRM to prevent the contamination of other inedible tissues;

• the identification of SRM and dead stock through the addition of markers, stains, tracers or other means and the tracking of movements of SRM and dead stock via record-keeping requirements from removal to final disposal or alternative use outside the food, feed and fertilizer production and distribution system to increase the certainty that these materials do not re-enter the human and animal food chains or the fertilizer system; and

• specifying the manner and conditions of destruction and disposal or alternative use for cattle SRM and dead stock removed from abattoirs or the farm to effectively reduce or contain any potential BSE infectivity in these materials and prevent other cattle in Canada's herd from being exposed to the BSE agent.

The CFIA proposes to sanction and control all activities concerning the segregation of SRM, the collection of dead stock from farms and the distribution, processing, destruction, disposal or alternative uses for these materials by permits issued under the authority of the Health of Animals Regulations. Permits and control measures will not be required for SRM or dead stock if they are destroyed or disposed of on the farms where they originate, but the disposition of these materials on farms would still be subject to any provincial agricultural, environmental or public health control measures in effect.

These federal measures will add an additional level of security to Canada's current feed ban. Preventing these potentially infectious materials from entering the entire feed production chain at the start diminishes the effects of potential cross-contamination of ruminant animal feeds that could occur as feed is produced and distributed, as well as any inappropriate on-farm use. Based on risk analyses, removing SRM from animal feed will more quickly reduce the incidence of BSE in North America by preventing future disease spread. As cattle alive at the time of or born shortly after the original feed ban came into effect in 1997 are eliminated from the national herd over the course of their life cycle, the possibility of infected animals is expected to be extinguished.

Rendered ruminant by-products manufactured from tissues not containing SRM would continue to be available for use in the manufacture of feeds for non-ruminant species such as poultry and swine which are not susceptible to BSE. Nevertheless, and in addition to the above requirements for SRM and dead stock, the Health of Animals Regulations will also be amended, as follows, to increase controls on the manufacture, identification and export of proteins prohibited from being fed to ruminants and of animal food and fertilizers containing these materials:

• Requiring the dedication of lines and equipment in commercial rendering facilities where the manufacturing, handling, storing or distributing of other remaining prohibited proteins takes place jointly with non-prohibited ingredients to prevent co-mingling or cross-contamination;

• Establishing a minimum mandatory rendering standard for the manufacture of MBM from inedible cattle by-products after the removal of SRM has also occurred. The standard would serve to further reduce any potential BSE infectivity remaining in the inedible material after removal of the SRM by an additional factor of one log (10^-1);

• Identifying proteins prohibited from feeding to ruminants and feeds containing prohibited proteins through the addition of markers, stains, tracers or other means. To enhance awareness of persons purchasing, handling and feeding products that contain prohibited proteins, the Regulations will be amended to require such products to be identified in a more conspicuous manner over and above the requirement of a warning statement on the product's label;

• Enhancing the directness and prominence of the warning statement on prohibited protein and feed labels from "Do not feed to cattle, sheep, deer or other ruminants" to "Feeding this product to cattle, sheep, deer or other ruminants is illegal and is subject to fines or other punishments under the Health of Animals Act", to raise the awareness of product users about their obligations with respect to the feed ban. This more direct warning statement will also be a new requirement on fertilizer labels where the product contains prohibited proteins; and

• Requiring the mandatory certification of exports of products of rendering plants or animal food or fertilizers containing these materials to control the potential spread of BSE to other countries from Canada.

These measures are to apply domestically and are in conformity with international standards contained in OIE guidelines for countries that have detected BSE. An import policy review is being conducted concurrently, and similar conditions may be considered for imported products from countries of similar or higher BSE risk as Canada.

Additional consequential amendments will be made to the Health of Animals Regulations as well as to the federal Feeds Regulations, 1983, the Fertilizers Regulations and the Meat Inspection Regulations, 1990 to coordinate regulatory control measures and to improve the consistency and enforcement of controls on commodities subject to these authorities.

• Extend the regulatory controls to manufacturing and importation of fish meal. Regulations administered by the CFIA have not applied to products and by-products that are derived from fish that could be used in animal food. However, the possibility exists that BSE could be spread via the adulteration or contamination of domestic or imported sources of fish meal with materials of cattle origin. The Regulations are being amended to allow for the control of domestic fish meal manufacturers and to require that permits be obtained from the CFIA to import this product from outside of Canada;

• Establish mandatory recall procedures for rendered products. Owing to some difficulties with the traceability of products experienced during the investigations of the Alberta BSE case reported in May 2003 and the Washington State case reported in December 2003, the Regulations are being amended to require manufacturers, importers and distributors of animal proteins and animal foods to have procedures in place that would facilitate an effective recall, if such an action is necessary. Moving to such a mandatory requirement is timely: in recent years many rendering enterprises have implemented good manufacturing practices or Hazard Analysis Critical Control Point (HACCP) systems voluntarily that should include a recall program as a component. It was intended that this mandatory recall provision also be extended to apply to manufacturers and distributors of animal food, but given the compressed period under which the proposed Regulations were prepared, this measure is not contained in the current proposal. It will be included in revisions made to the regulatory text in time for the publication of the Regulations in the Canada Gazette, Part II;

• Extend the mandatory record-keeping period from two to seven years. Given the long incubation period for BSE in cattle (on average, from four to six years), requiring records to be kept for a longer period is being proposed to facilitate any possible future investigations should additional cases of BSE be detected in Canada; and

• Amend the exceptions for the feeding of tallow and gelatin to ruminants in the current feed ban. Tallow (fat) derived from ruminants is permitted to be fed to ruminants at present. In keeping with an international standard established to allow for the unrestricted trade of tallow, the definition of "prohibited material" in the current feed ban is being amended to permit only the feeding of "protein-free tallow" from mammals (tallow containing less than 0.15 percent insoluble impurities) and gelatin exclusively from hides and skins to ruminants.

The Government has carefully considered whether there is a need to stop the feeding of ruminant blood products to ruminants. This change is not being proposed at this time. Fresh blood is not an SRM tissue. While recent research reports on the transmission of TSEs through blood transfusions have created some uncertainty about the risk that feeding certain blood products poses to the transmission of these diseases, there is, to date, no clear scientific evidence to demonstrate that the transmission of BSE has occurred via the consumption of blood products in feeds.

Now that BSE has been detected in Canada, the question has been raised whether blood collected for use as an animal food ingredient from slaughtered cattle potentially infected with BSE could become contaminated with the disease agent during the stunning and further processing of cattle carcasses. As a result, an amendment to the feed ban definition of "prohibited material" to include blood was considered. This would have meant that blood products derived from mammals (with the exception of swine and horses) would no longer be permitted to be fed to ruminants. Rather than remove this exception at this time, blood collection practices at abattoirs will be re-assessed and collection procedures will be amended administratively if risk of contamination by other tissues is of concern.

• Definitions and the restrictions on the use of SRM in livestock feeds are being added to these commodity-specific regulations to provide clarity and consistency with the Health of Animals Regulations. In addition, references to the Health of Animals Regulations are being inserted to broaden enforcement actions available for specific products that do not comply with the SRM and feed ban provisions (for example, cancellation of registrations for non-compliance with the feed ban requirements).

• Adding prohibitions and standards for ingredients of animal origin. In addition to adding prohibitions on feeds containing proteins derived from SRM, cattle and other condemned and dead stock ruminants to the Regulations, an additional prohibition is being included for proteins derived from animals not raised for food production purposes other than fish. This measure is being added to keep animals such as those accidentally killed along roadsides and other rights of way, research animals, zoo animals and others from being collected and processed into livestock feed ingredients. Furthermore, a standard for fats that are or may contain fats of ruminant origin (containing not more than 0.15 percent insoluble impurities) is being added.

• Requiring livestock feeds to be labelled with a complete list of ingredients. At present, livestock feeds are not required to be labelled with a complete list of ingredients; most often, the label refers purchasers to the manufacturer for the list. To enhance purchasers' awareness of the composition of the products, an amendment is proposed that would require livestock feeds to be labelled with a complete list of ingredients.

With respect to the Fertilizers Regulations, additional consequential amendments will be made to enhance awareness about the feed ban and improve the consistency and enforcement of controls on commodities subject to these authorities. The following measures will add an additional level of security to Canada's current feed ban by preventing these potentially infectious materials from entering the entire feed production chain:

• Prohibiting the use of proteins derived from cattle SRM and dead stock from use in fertilizers. The use of raw, unprocessed or composted SRM and tissues from condemned animals and dead stock are also to be prohibited from use in any fertilizers, as would any proteins derived from the rendering or other processing methods of these tissues. There is uncertainty surrounding the behaviour in the environment of the agent believed responsible for causing BSE, meaning restrictions to prevent the potential contamination of pastures, soils, and surface and ground waters would be prudent. In addition, allowing these materials to be used in fertilizers would make it difficult to prevent the potential accidental or intentional misuse, on farms in particular, of fertilizers such as bone meal and blood meal as feedstuffs;

• Requiring mandatory registration of fertilizers and supplements that potentially contain material of animal or plant origin (e.g. blood meal, garbage tankage, hoof and horn meal, paunch manure, composted manure, processed sewage, tankage, blood and bone meal, acidulated bone, bone meal, and compost);

• Requiring the addition of enhanced warning statements on fertilizer and supplement labels (e.g. "Do not use on pasture or hay lands", "Do not apply within 3 metres of a body of water", "Do not ingest", "Wash hands after use");

• Requiring every package containing a fertilizer to have a label affixed to it on which shall be printed the lot number of the fertilizer; and

• Linking the Fertilizers Regulations with the Health of Animals Regulations for clarity, consistency and enforcement purposes. To provide clarity and consistency with the Health of Animals Regulations, definitions and the restrictions on the use of SRM in fertilizers are being added to the commodity-specific regulations. In addition, references to the Health of Animals Regulations are being inserted to broaden enforcement actions available for specific products that do not comply with the SRM and feed ban provisions (e.g. refusal to register a fertilizer for non-conformance with animal health-related import requirements).

The addition of these measures will assist in the protection of both animal and public safety. These measures will reduce the potential of future contamination; require the registrants to provide documentation demonstrating the safety, merit and value of the product; raise the awareness of product users about the feed ban; and facilitate recalls if such action is necessary.

• Amend existing Regulations to eliminate exceptions for products and things (e.g. meat products, pet food, animal feed, condemned carcasses) that could contain SRM in domestic and export trade as well as imported products potentially containing SRM from other BSE-affected countries.

Comments are requested on these suggested refinements as well, and the changes will be considered in any subsequent revisions made to the regulatory text as part of completing the Regulations after the comment period and prior to their publication in the Canada Gazette, Part II.

Option 1 – Requiring increased dedication of production facilities, lines, equipment and conveyances along the feed production chain with increased inspection and enforcement for compliance

Within the current feed ban regulatory framework, operators of facilities and conveyances that manufacture, handle and use prohibited and non-prohibited proteins can use common facilities and equipment, provided that measures are taken to prevent the mixing or contamination of products that are destined for feeding to ruminants with prohibited proteins. While some voluntary dedication of facilities and equipment has occurred since the cases of BSE were detected, imposing mandatory requirements to dedicate facilities and equipment would serve to further reduce opportunities for mixing or contamination of ruminant feed with prohibited proteins. At the same time, the Government would need to increase the number of compliance inspections and enforcement activities along the entire production chain to obtain a higher degree of assurance that compliance with the ban is being achieved.

This option, however, is not viewed as positively as the others considered, as it would not serve to further prevent the entry or remove any potential BSE infectivity from the animal food production chain. In the absence of definitive feed testing methods, even high levels of compliance with these enhancements would not necessarily mean the ban would be completely effective. The imposition of more dedication in the animal food production chain would be costly to implement within certain sectors along the chain, particularly at the lower end, where feed manufacturing at the commercial and on-farm levels is concerned. In addition, the Government would incur much higher inspection and enforcement costs that may not result in an increased level of confidence in the effectiveness of the ban. This option also fails to address the recommendations of the international team of animal health experts that reviewed the Canadian BSE situation, and would do little to reassure Canadians or Canada's international trading partners that all reasonable measures are being taken to contain risks and eliminate the disease.

Option 2 – Removal and redirection of specific infectious material from the animal food chain, including pet food, and from fertilizers

While the Government developed and proposed this option as a discrete package along the lines of the human food SRM ban implemented in 2003, what has emerged during consultations with stakeholders during the past year is that the removal of a range of cattle SRM tissues required consideration in the makeup of this option. As a result, the Government has been evaluating the potential impacts of removing from the animal food chain:

2(a) condemned and dead stock cattle aged 30 months and older, as well as the brain and spinal cord from slaughter cattle aged 30 months and older;

2(b) condemned and deadstock cattle of all ages as well as the brain and spinal cord from slaughtered cattle aged 30 months and older;

2(c) condemned and dead stock cattle as well as the full list of SRM tissues presently banned from use in human food (i.e. the skull, brain, trigeminal ganglia, eyes, tonsils, spinal cord and dorsal root ganglia of cattle aged 30 months or older and the distal ileum of cattle of all ages); and

2(d) condemned and dead stock cattle as well as the full list of SRM tissues presently banned from use in human food (i.e. the skull, brain, trigeminal ganglia, eyes, tonsils, spinal cord and dorsal root ganglia of cattle aged 30 months or older and the distal ileum of cattle of all ages), as well as dead stock and condemned ruminants.

The Government's preferred option is option 2(d) above (full list of SRM tissues removed) as well as the removal of all ruminant dead stock and condemned ruminants. This option would address the recommendations of the international team of animal health experts that reviewed the Canadian BSE situation. Additional analysis of these sub-options and the rationale for the choice of the preferred sub-option is provided in the "Benefits and costs" section that follows below.

Option 3 – Removal of all ruminant meat and bone meal from the animal food chain

This option would result in the removal of all potential BSE infectivity from the feed chain and achieve the eradication of BSE in Canada to a level and time line comparable to that of option 2(d). However, this option would go beyond the recommendations of the international team of animal health experts that reviewed the Canadian BSE situation, impose additional costs on industry and produce additional volumes of waste products for disposal without providing further substantial reduction in the level of BSE risk.

This option would not result in the removal of any additional potential BSE infectivity from the feed chain relative to that of option 2(d) or 3. This option would also go beyond the recommendations of the international team of animal health experts that reviewed the Canadian BSE situation, impose additional costs on a broader range of livestock and food processing sectors and produce very large volumes of waste products for disposal without providing further substantial reduction in the level of BSE risk.

In considering the benefits and costs of various options and suboptions for enhancing Canada's animal feed restrictions related to BSE risk, it is important to recognize that the relative probabilities of further transmission of BSE to other animals and, indirectly, exposure to people through food or other human uses of rendered bovine tissues are low. However, it is equally important to recognize that the potential animal health, public health and/or economic consequences remain very substantial. This has been demonstrated, in the case of the United Kingdom, by the human deaths caused due to vCJD in Europe and more recently, in Canada's case, by the economic damage incurred subsequent to the detection of BSE in a Canadian-born cow in May 2003. International markets have thus far remained at least partially, and in many cases, fully closed to Canadian exports despite the scientifically assessed low level of risk associated with eating Canadian beef given the measures we have taken.

Given the magnitude of potential negative consequences and the global context in which Canada must operate as a large net exporter of beef and beef products, livestock and livestock products, the Government is seeking to achieve a very high level of protection. As such, the analytical framework used to assess the benefits and costs of SRM removal suboptions is as follows.

In order to prevent future cases of BSE and effectively eradicate the disease in the shortest practically achievable time frame, the proposed amendments should

• cause SRM to be removed from the animal food chain in a manner that mitigates risks associated with

• potential adulteration or cross-contamination of ruminant animal feed with prohibited protein of ruminant origin, and

• potential on-farm misuse of feed containing prohibited protein of ruminant origin.

• is credible domestically, in that it contributes to public and animal health protection and efficient functioning of the domestic market for livestock and livestock products;

• is credible internationally, in that it contributes to the safety of livestock and livestock products exported from Canada and related market access opportunities;

• takes into account opportunities for reintegration of the North American market; and

• does not unnecessarily contribute to environmental or waste management challenges.

The proposed regulatory amendments, which build on the existing regulatory framework, would be very effective in preventing future cases of BSE in Canada. By removing essentially all of the tissues that could contain infectivity at the top of the animal food chain, these measures would effectively mitigate the risk of transmitting BSE due to either (a) potential adulteration or cross-contamination of ruminant animal feed with prohibited protein of ruminant origin during manufacturing and distribution, or (b) potential on-farm misuse of feed containing prohibited protein of ruminant origin on those farms with multiple species.

Canada's existing feed ban should lead to the eventual eradication of BSE. However, experiences in the United Kingdom and other BSE-affected countries indicate that residual levels of infectivity are likely to prolong the time required to eradicate BSE in a domestic cattle herd. This is in part due to the relatively low level of infectivity required to transmit BSE. Considering this, and following the international panel report, a model was developed to determine how quickly BSE could be eradicated from Canada under the existing feed ban compared with a number of options to augment the ban ("Enhanced Feed Ban Options – Risk Reduction Model and Analysis," available upon request). It is important to note that the model does not attempt to predict the absolute incidence of BSE in Canada.

Based on a reasonable set of assumptions, the model results indicate that while the current ban will, in all likelihood, lead to the eventual eradication of BSE, the rate of progress to eradication is likely to be much faster if SRM, dead stock and condemned animals, as described in these proposed Regulations, are also excluded from the feed chain. In this case, the predictive model suggests that BSE is likely to be virtually eradicated from the cattle population after 10 years compared to potentially several decades under the existing feed ban. This results from the exclusion of virtually all (99.998 percent) of the tissues known to carry infectivity from the manufacture of meat and bone meal (MBM). Furthermore, the model suggests that a full SRM ban would have the same effect as banning the feeding of all ruminant MBM because essentially the same set of tissues known to be infective would be removed from the feed chain under both options.

Under the proposed Regulations, the minimum mandatory rendering processing standard applicable to the manufacture of ruminant meat and bone meal, still eligible for use in non-ruminant animal food, would effectively act as a secondary firewall that ensures a minimum of one log reduction in any level of infectivity that may be introduced into the feed chain due to incomplete removal of SRM upstream. Therefore, it is not necessary to impose new dedication requirements for feed milling, distribution and on-farm manufacturing and use of animal feeds. Additional controls down the animal food chain can be kept to a minimum, rather than having to tightly manage opportunities for incidental exposure of cattle through cross-contamination or on-farm misuse of feed.

In addressing public health and food safety issues, the removal, destruction or treatment, and safe disposal of SRM's, dead stock, and animals that are condemned for human consumption, from both human and animal feed chains, are key factors in meeting the goals of the Government of Canada's comprehensive TSE strategy.

Recent scientific publications have shown that vCJD has the potential to be transmitted through blood transfusions and that a larger proportion of the human population are genetically susceptible to this disease. These two new scientific findings have extended the scope of public health concerns and emphasizes the need to strengthen measures to mitigate against the amplification, the recycling, and the potential human exposure to the BSE agent through food and regulated health products. BSE surveillance in Canada has increased, but the level of BSE in the Canadian cattle herd has as yet not been established.

Industries source domestically produced ruminant ingredients for use in the manufacturing of food products and regulated health products. Ruminant tissues and rendered ruminant by-products are used as ingredients or in processes for the production of human and veterinary therapeutic products, biologicals, cosmetics, medical devices, and natural health products. Canada no longer meets the international standards for classification as a BSE free country. The extended feed ban and control of risk materials will provide the standards needed by government and industry to assure and certify the safety of these products. For example, in the risk categories of dead stock and condemned animals, the reported rate of BSE is understood to be 25 times higher than that generally found in surveillance at abattoirs. Requiring removal of all SRM and prohibiting the inclusion of all dead stock and condemned cattle in these risk categories from entering the feed chain will achieve a higher level of public health protection. The actions to divert all other ruminant species of dead stock removes the potential amplification, recycling and human exposure to other animal TSE's. The new controls ensure that the potential risks due to human error are removed and will strengthen compliance.

Beef production provides a safe and nutritious food supply and also contributes to Canada's economy. Canada's beef industry is the largest single commodity source of farm cash receipts with the sale of cattle and calves valued at $5.2 billion in 2003 and accounting for 15 percent of total farm cash receipts (down from $7.6 billion or 21 percent of the total farm cash receipts in 2002). Beef production's contribution to the rest of the economy was $20 billion in 2003 (down from $30 billion in 2002) and were generated in processing, retail, food service and transportation sectors.

It is anticipated that removal of all SRM from the animal food system in Canada will be viewed positively both by Canadians and Canada's trading partners, as a scientifically sound approach to completing Canada's domestic risk management response to the detection of BSE. The complete removal and redirection of all SRM from the animal food chain would conform fully with the recommendations of the international panel. By doing so, the proposed amendments would reinforce public and consumer confidence domestically. They would also provide strong assurances to downstream suppliers of beef products direct to retail that BSE (and therefore market) risks are being effectively mitigated. Canada's trading partners, generally, are also expecting Canada to take an exhaustive approach in its response to the recommendations of the international panel of BSE experts that reviewed its situation.

The removal of all SRM would also be in conformity with both existing and all proposed feed-ban related elements of the international BSE standards of the World Organization for Animal Health (OIE). The OIE is the internationally recognized body setting standards for animal health, including zoonotic diseases that present a public health threat. The current OIE standard recommends the imposition of a ruminant-to-ruminant feed ban that is effectively enforced. This international animal health standard is undergoing revision, however. At the last general session of the OIE (May 2004), several member governments proposed that SRM must be removed from all animal feed in order for a country that has reported BSE in an indigenous animal to qualify for classification as a country with minimal or negligible BSE risk with mitigating measures. It is not possible to predict at this time whether such a recommendation will, or will not, be included in any amendments to the BSE Code Chapter of the OIE at its next general session in May 2005. However, were this to be the case, it would result in Canada being classified under the OIE as having an "undetermined" level of BSE risk if SRM is not being removed from the feed chain.

Regardless of how the OIE standard evolves, in practical terms, it is the underlying perspective of individual countries that ultimately guides how Canada's trading partners will judge our risk management response to the detection of BSE. On the one hand, in other countries where BSE has been detected in an indigenous animal, removal of at least all ruminant meat and bone meal from the animal food chain domestically is presently required (e.g. EU, Japan). Those countries in which BSE has not been detected continue to maintain a very low (virtually "zero") tolerance to BSE-related risk that could be associated with imports. In Canada, there were a number of measures in place that effectively reduced the BSE risk prior to the detection of BSE. This was supported by several years of surveillance data. Canada is well positioned to demonstrate scientifically that the framework of Canada's current ban augmented by removal of all SRM from animal food is equivalent to more extreme responses taken by other countries.

Although the current OIE standard contains an undifferentiated recommendation opposed to international trade in ruminant meat and bone meal from countries with BSE, the complete removal of SRM from the entire animal food chain would position Canada to begin making the scientific case that, under certain circumstances, it can safely export meat and bone meal derived from tissues not containing SRM.

These proposed amendments should position Canada to more rapidly secure market access to a larger number of countries for a wider range of products than would otherwise be the case, including beef and beef products, live cattle, and other ruminant animals and their products. Canada would be even better positioned to provide certification of the products it exports based on the strength of the risk management measures it has implemented. In this respect, the proposed amendments would be supportive of Canada's strategy to reposition itself as a much more important global exporter of premium meat and meat products, livestock and genetic material.

Canada's export sales of live cattle and beef in 2002 were about $4.0 billion. In order to restore and expand our export markets, a Canadian repositioning strategy has been built on increasing slaughter capacity to enhance value-added processing and to reduce reliance on live animal exports to the United States. With this strategy, slaughter capacity is targeted to increase from a processing capacity of 79 000 head per week to reach 104 000 head per week by the second half of 2006. Based on this capacity, industry sources indicate that Canada's beef exports are anticipated to reach 1 000 000 tonnes. Up to half (500 000 tonnes) of the increase, valued at some $1.98 billion, is likely to be marketed to non-U.S. destinations by 2007, of which, 300 000 tonnes could be marketed to Asia, 150 000 tonnes to Mexico and 50 000 tonnes to other markets according to industry sources. In addition, tapping these markets could generate higher revenue as some beef products are sold at premiums to Asia and Mexico. Again, industry sources indicated that sales of AAA-graded beef to Asia and AA-graded beef to Mexico produced significant premiums over selling those same products in either the domestic or U.S. markets. Exports of thin meats and offal created $192 additional value on a per head basis.

The contribution of these amendments to the reintegration of the Canadian and U.S. markets for livestock and livestock products is dependent, in part, on two U.S. rule making processes. The first of these is the U.S. Department of Agriculture's proposed rule that would establish a new minimal risk category of countries under which Canada is seeking to resume access for live animals and other products still affected by U.S. BSE-related import restrictions. One of the risk factors considered in assessing a country as minimal risk under that proposed rule is the effectiveness of the exporting country's animal feed restrictions. It is understood that these minimal risk criteria should provide scope for the detection of some additional BSE cases born in Canada before the current feed ban. However, it is less clear that this would be the case were Canada to find a BSE-positive animal born after the introduction of its feed ban in 1997. These proposed amendments would position Canada to minimize the potentially large negative economic consequences associated with such an event should it occur on the basis that all potentially infective tissues should by that time have been removed from both the human and animal food systems in Canada. This argument would be equally relevant with respect to the potential reaction of Canada's other trading partners.

The second factor is the nature and pace of modifications that may be made by the United States to its feed ban. On July 9, 2004, in an Advanced Notice of Proposed Rule Making in which the U.S. Government was seeking general comments, the U.S. Food and Drug Administration (FDA) signalled its preliminary conclusion to also require the removal of SRM from the animal feed chain. The Canadian Food Inspection Agency continues to liaise with the FDA with a view, where possible, to harmonizing our respective feed ban enhancements in order to allow scope for inspection efficiencies and reintegration of livestock and feed markets, taking into account common BSE risk factors on both sides of the border.

Incremental costs to industry, primarily to the beef value chain, associated with these proposed amendments are difficult to predict with precision. The principal changes in cost would be anticipated to result from

1. any marginal impact on costs of transporting and processing SRM and/or dead stock necessary to meet new requirements for segregation of these tissues from the animal food system (recognizing that there are already costs associated with these activities within the feed chain);

2. lost revenue, net of production costs, for that portion of MBM that is currently derived from SRM or dead stock that will no longer be eligible for sale as animal food or fertilizer; and

3. any new incremental costs for disposal of SRM and dead stock, or MBM derived from them, until such time as alternative uses are developed and/or implemented.

Where cattle (beef or dairy) are presented for slaughter, the marginal increase in costs that would be incurred result mainly from the requirement to segregate and dispose of SRM (roughly 8 percent of the weight of a cull cow and 2.5 percent of a slaughter steer) outside of the human food (edible) and animal (inedible) food production systems. Costs and revenues associated with processing and sale of the remaining tissues (both edible and inedible) should be largely unaffected. For example, the remaining 27 percent of a cull cow and 31.5 percent of a slaughter steer that is inedible by-product, no longer containing SRM, would continue to be eligible for rendering into MBM and subsequent incorporation in non-ruminant animal feed rations or fertilizers for which there would continue to be a market in Canada and, potentially, in international markets.

Ruminant animals that die on farm would be subject to new controls over disposal or use of the animal carcasses only where this occurs off the farm. There may be marginally higher costs for dead stock collection and, where available, disposal rendering (or other primary treatment), due to requirements for segregation and disposal outside of the animal food or fertilizer system. Costs and revenues associated with harvesting the hides and extraction of fats should not be significantly affected.

Together, these annual costs to industry have been estimated by the CFIA to range from $20 million up to $27 million (detailed calculations are available on request). These costs represent up to 0.1 percent of beef production's contribution (approximately $20 billion in 2003) to the Canadian economy. For SRM removed at beef processing plants, the ongoing costs in the short run are expected to be comprised of the costs of operating a separate inedible by-product line within beef processing plants (that are already required to remove SRM from the carcass), plus the cost of segregated transportation from the beef plant in many cases to a primary treatment facility, plus marginal increase of SRM processing (e.g. rendering) cost, plus the cost of disposing of meat and bone meal, plus the loss of value from MBM sales for feed or fertilizer (net of MBM production costs no longer incurred by that enterprise). The proposed Regulations would require that when the carcass of a ruminant animal that dies on farm (or its constituent parts or products derived from it) leaves the farm, the receiver of that carcass must operate under a CFIA-issued permit. For dead stock removed from the farm, these ongoing costs associated with the proposed Regulations would be comprised of dead stock pickup/transportation costs, plus marginal increase in processing (e.g. rendering) cost, plus the cost of disposing of meat and bone meal, plus the loss of value from MBM sales for feed or fertilizer (net of production costs no longer incurred by that enterprise).

From an environmental perspective, the requirement to remove and dispose of SRM away from the animal feed system will result in a volume of animal tissue that will require an alternative means of disposal. The proposed Regulations contain an SRM disposal requirement to protect public and animal health in a manner that is intended to complement provincial environmental and waste management responsibilities, thereby mitigating any potential environmental damage.

On the basis of the CFIA's estimates, collectively, some 170 000 tonnes of raw SRM material might be generated annually in Canada that would require redirection from animal food uses. If all this material were to be rendered, some 44 000 tonnes of MBM would remain and need to be destroyed, disposed of or used in an alternative fashion. To put this volume into context from a waste management perspective, it is also estimated that each household in Canada generates some 750 kg to 1 000 kg (where 1 000 kg equals 1 tonne) of solid waste per year. For the estimated 11 000 000 households in Canada, upwards of 11 000 000 tonnes of solid waste is being generated and managed in Canada annually.

In some regions, dead stock pickup and/or rendering are already relatively uneconomical or in short supply. In these situations, burial at a cost of roughly $38 per tonne (draft Sparks/GMC study) or landfill at about $75 per tonne (Cargill) may be more economical than rendering. However, the costs and relative availability of such disposal alternatives varies across the country and by jurisdiction.

In recognition of the multi-jurisdictional and varied nature of these challenges, in parallel with these proposed amendments, federal/provincial/territorial ministers of agriculture have initiated a separate process, led by Agriculture and Agri-Food Canada, to identify the most efficient and environmentally acceptable SRM disposal options by province/territory.

It is also important to note that the proposed amendments provide scope for adopting alternative uses of SRM (e.g. in cement production or co-generation of energy) which have the potential to either reduce the disposal cost or even to generate new revenue streams for the beef industry over the medium to long run.

Costs to governments are expected to approach those incurred by the beef value chain. For the CFIA, based on the proposed amendments, it has been estimated that the annual cost of providing inspection oversight and program verification would be $23 million to $27 million.

Provincial/territorial regulatory authorities would be expected to incur some marginal cost increases associated with oversight of segregation of SRM removed in non-federally registered meat plants and disposal of SRM and dead stock where this falls within their jurisdictions.

Comparative benefits and costs of alternative sub-option 2(b) for removing SRM

In the context of consulting over alternative approaches to enhancing the feed ban, considerable debate and interest has focussed on the degree of SRM removal that is required to achieve Canada's regulatory objectives. A major beef packer has argued that it is not necessary to remove all dead stock nor all SRM from the animal feed chain in order to achieve a comparable level of risk mitigation. The specific alternative, sub-option 2(a) put forth, included removal from the feed chain of dead stock cattle over 30 months of age only, and brains and spinal cords from slaughter cattle over 30 months of age only. It was argued that the remaining level of potential infectivity that would be left in the feed chain could be sufficiently reduced during the rendering process if certain practices were phased out. It was also argued that the major benefit, when compared with the proposed Regulations, would be a smaller volume of tissue removed from the meat complex and, therefore, lower costs to the beef value chain associated with SRM disposal.

This alternative proposal has been examined carefully by the CFIA. With respect to the aspect of the proposal that differentiates between the treatment of dead stock over 30 months versus those that die on farm at a younger age, the CFIA does not consider this to be a prudent approach, particularly from a practical enforcement perspective. Outside of animals displaying clinical signs of BSE, dead stock are among the at-risk population of cattle where BSE-positive cases are most likely to be found. It would be impractical for the CFIA to be able to effectively enforce the segregation on farm of over-30-month-dead stock versus under-30-month-dead stock, thereby opening up opportunities for the reintroduction of relatively higher-risk cattle into the animal feed chain at rendering establishments that produce MBM for animal feed. Consequently, the remaining comparison of benefits and costs apply to an amended alternative, sub-option 2(b), whereby dead stock of any age are excluded from animal feed along with the brain and spinal cord of slaughter cattle over 30 months of age.

From an animal health perspective, the alternative considered would leave approximately 9 percent of the potential infectivity associated with SRM in the animal food chain, subject to other controls under the feed ban. In this case, the rendering standard applicable to the manufacture of meat and bone meal, still eligible for use in non-ruminant animal food, would no longer be a redundant step. Instead, it would be intended to ensure a minimum of one log reduction for the routine introduction of SRM containing this potential infectivity. Any additional infectivity that may be introduced into the feed chain, for example, due to incomplete removal of the brain from the skull, would be over and above this quantity.

Based on certain assumptions, the predictive model suggests that a partial SRM ban, where dead stock, condemned cattle, brains and spinal cords are excluded from the feed chain, would be almost as effective at accelerating the path towards eradication as the exclusion of all SRM from the animal feed chain. One of these assumptions is that the processes implemented in beef packing plants would consistently achieve a very high rate of extraction of brain tissue out of the cranial cavity, a practice that has not been verified by the CFIA.

The alternative sub-option and related model results must also be weighed in the context of other relevant factors such as international expectations, consumer acceptance, and the potential emergence of new information or circumstances. Now that Canada is understood to be producing beef within a North American livestock complex where BSE is known to exist in the indigenous herd, the routine introduction into the feed chain of tissues known to contain infectivity in BSE-positive cattle (and already banned from use in human food) would require consideration of additional controls and inspection oversight downstream along the animal food chain. One such measure could be the complete dedication of facilities used to manufacture MBM and that mix animal feed in order to mitigate against the risks associated with the potential for greater than an incidental degree of cross-contamination and/or misuse of feed on farm, in light of the small quantities of infected material necessary to transmit BSE to cattle through oral ingestion.

In light of the uncertainties that still remain about BSE and the link to vCJD, Canada must take action to reduce public health risks posed by BSE beyond prohibiting the use of SRM tissues in human food products. By requiring the removal and control (from the primary point sources of these materials through to destruction or disposal) of the full list of SRM as listed in the Food and Drug Regulations, this would serve to address the issue of potential human exposure to BSE from tissues following other pathways into non-food products. However, by requiring the removal and redirection of only a partial list of SRM tissues from animal food uses, there would still exist opportunities for some of the remaining SRM tissues not banned from animal food use to continue to be used in non-food products and for potential exposure pathways.

While there is some scientific merit in the alternative approach, it would rely on a somewhat more complex series of risk management measures that would be more difficult to explain to the general public and foreign government authorities. As such, it may not garner the same level of domestic and international acceptability or credibility in the face of low-probability events that could result in large economic consequences associated with the rejection of beef in the marketplace or loss of market access. For example, were Canada to detect a BSE-positive cow born after the introduction of the 1997 feed ban, it would be more difficult to explain convincingly how leaving, albeit a relatively small portion of, potential infectivity in the animal food chain, subject to further reduction through rendering, is equally effective at reducing BSE risk compared to total SRM exclusion. It is a somewhat more difficult alternative with which to comply and to enforce and there are no analytical methods that could be applied downstream to provide the same level of assurance of absence of infectivity in MBM and/or animal feed.

Arguably, it would not conform fully to the recommendations of the international panel. It would, however, conform with the current OIE BSE standard as it relates to animal feed but not necessarily with future incarnations of that standard, as recommended by some member countries.

Therefore, this alternative would not be expected to lead as quickly to entry or re-entry into international markets for as wide a range of livestock and livestock products as the proposed amendments, particularly live animals and MBM. This alternative would in all likelihood rule out any credible argument for resuming exports of MBM to most countries until such time as Canada is recognized as having eradicated BSE, 10 or more years into the future.

The major advantage of the alternative considered would be to reduce the volume of SRM that the Regulations would require to be removed and disposed of outside the animal food chain, thereby lowering costs to the beef value chain. If no additional controls were to be required downstream along the animal food chain to address the potential for cross-contamination or misuse of feed on farm, this would be expected to reduce costs to the industry by approximately $8 million. Under this scenario, costs to the beef value chain have been estimated to range from $12 million to $19 million. In principle, the volume of SRM that would require disposal under this alternative option would be reduce from 170 000 tonnes to 134 000 tonnes, which is a 21 percent reduction from the preferred option.

Additional dedication requirements applicable to renderers and commercial feed mills could result in a shifting of cost down the feed chain. Commercial feed mills have indicated that any requirement for them to dedicate facilities or lines would lead, in most cases, to total abandonment of ruminant-based MBM as a feed ingredient because costs of dedicating facilities would be prohibitive.

Under this alternative option, the total annual costs to the CFIA have been estimated to be approximately $27 million. Given the role of rendering as a key step at the top of the chain, there would be increased demand for a more intensive level of inspection oversight down the feed chain, at feed mills and on farm. This would stem from the need to demonstrate the effective mitigation against the risks associated with the potential for greater than an incidental degree of cross-contamination and/or misuse of feed on farm, in light of the very small quantities of infected material necessary to transmit BSE to cattle.

The overall animal health, public health and related economic benefits to Canada expected to be derived from the proposed amendments, while difficult to quantify, would significantly outweigh total costs. Furthermore, the net benefit is expected to be greater under the proposed amendments than under the alternative sub-option, in large part due to the more certain outcomes that would be achieved in terms of animal health, public health and domestic and export market opportunities.

Within weeks of the detection of the index case of BSE, the Government began consulting on the three principal enhancement options discussed in detail above. Domestically, the consultations were largely with members of the Beef Value Chain Roundtable (representing beef and dairy cattle producer organizations, beef packers, commercial rendering, feed and food service industry associations along with federal and provincial government representation). The views of the Roundtable members have routinely differed in respect of the scope and timing of changes that might be necessary.

Internationally, routine communication and discussions were held with USDA and U.S. FDA officials. To this end, both the governments of Canada and the United States announced concurrently on July 9, 2004, that they were each considering moving forward (in Canada's case, specifically intending to do so) with the development of proposals to enhance the feeding bans in their respective countries. Officials and delegations from other governments (e.g. Japan, Taiwan, and Hong Kong) have also been regularly advised of developments associated with the Government's measures to respond to BSE, including those concerning potential feed ban enhancements.

Following the July 9 announcement, government representatives met bilaterally with members of the Animal Nutrition Association of Canada (feed industry trade association), the Canadian Renderers Association, the Canadian Meat Council (beef packers), the Canadian Restaurant and Foodservices Association of Canada and the Canadian Cattlemen's Association over a period of several weeks in August and September 2004 to discuss in some detail the enhancement measures being considered.

As a means of providing more details about the specific regulatory changes the Government has been considering, the CFIA prepared and released an information paper, "Development of Specific Regulatory Enhancements to Canada's BSE Feed Controls" (see www.inspection.gc.ca/english/anima/feebet/rumin/ docinfoe.shtml or a copy is available upon request), in late September 2004 to a broad group of domestic animal industry groups via the Canadian Animal Health Consultative Committee (CAHCC, see www.inspection.gc.ca/english/anima/heasan/cahcc/ cahcc_e.shtml) as well as other agricultural and food industry organizations, provincial and territorial government agencies, universities and other interest groups for their review and comments. Since the information paper has also been posted on the CFIA Web site, feedback has been received from U.S. agricultural and food industry sectors and other trading partners. Subsequent to the release of the paper, the CFIA and other government representatives have participated in industry and government meetings and on conference calls upon request to discuss the details contained in the paper and answer questions.

As of November 16, 2004, the following organizations have provided the CFIA with comments on the information paper in writing:

Ministère de l'agriculture, pêcheries et alimentation du Québec (MAPAQ) — Centre québécois d'inspection des aliments et de santé animale

Almost without exception, from the comments received, there is support for enhancing Canada's feed ban by removing cattle SRM and dead stock tissues to a greater or lesser extent from the animal food chain. There is less general support for requiring the dedication of facilities, production lines, equipment and conveyances at various points in the animal food and production chain, particularly at the lower end of the chain where the manufacture and feeding of livestock rations are concerned. Beyond these major issues, the comments are more issue- and sector-specific in nature and opposing viewpoints on the same subject have been noted.

The CFIA will continue to verify compliance of the regulated products with the existing legislation. These additional measures will further enhance the CFIA's abilities to ensure both animal and public safety by way of inspection activities at the following types of establishments:

As well, the CFIA anticipates having to verify compliance with the new regulatory enhancements by way of issuing permits for and delivering new inspection activities at

• meat slaughter and processing establishments where SRM are removed (in partnership with provincial agencies, in some cases);

• conveyances and enterprises that operate conveyances used to transport SRM, dead stock, processed animal proteins, other feed ingredients and prepared feeds;

• receivers of SRM and dead stock for pretreatment, disposal or other alternative uses.

Additional resources will be necessary to enable the CFIA to deliver the additional compliance and enforcement activities identified above. To this end, the CFIA is presently seeking additional resources from the Treasury Board to support the delivery of these activities.

The CFIA has agreements with the Canada Border Services Agency to monitor and hold imported animals and other things, including animal products and by-products, which are prohibited or controlled under the Health of Animals Act. These commodities are inspected by CFIA inspectors to ensure that the requirements of the regulations have been met before they are allowed to enter Canada.

Section 16 of the Health of Animals Act requires that an importer of an animal or any other thing that could introduce disease into Canada must present the animal to a CFIA inspector or to a Customs officer.

Inspectors will add the inspections at the other facilities required under this regulatory amendment to the duties already performed in rendering plants and feed establishments. Inspectors will also verify feed invoices and labels and assess the types of feed during their routine visits to farms.

Inspectors will add the inspections at the other facilities required under this regulatory amendment to the duties already performed in fertilizer or supplement retail establishments. Evaluation officers will verify the safety, merit, and value of the fertilizer or supplements prior to issuing registration certificates for those products.

Section 65 of the Health of Animals Act provides for punishment upon conviction of refusing or neglecting to perform a duty imposed by the Act or the regulations.

Introduction of the Administrative Monetary Penalty system will also provide an option for those individuals found to be in contravention of these regulations. Amendments to the Agriculture and Agri-Food Administrative Monetary Penalty Regulations will also be prepared to introduce penalties for violations of these regulatory requirements.

Sergio Tolusso, Animal Health and Production Division, Canadian Food Inspection Agency, (613) 225-2342 (telephone), (613) 228-6614 (facsimile), stolusso@inspection.gc.ca (electronic mail).

Notice is hereby given that the Governor in Council, pursuant to section 5 (see footnote a) of the Feeds Act, subsection 5(1) (see footnote b) of the Fertilizers Act, subsection 64(1) (see footnote c) of the Health of Animals Act (see footnote d) and section 20 (see footnote e) of the Meat Inspection Act (see footnote f), proposes to make the annexed Regulations Amending Certain Regulations Administered and Enforced by the Canadian Food Inspection Agency.

Interested persons may make representations with respect to the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to Mr. Sergio Tolusso, Program Coordinator, Feed Section, Canadian Food Inspection Agency, 59 Camelot Drive, Ottawa, Ontario, K1A 0Y9 (Tel: (613) 225-2342 extension 4377; Fax: (613) 228-6614).

REGULATIONS AMENDING CERTAIN REGULATIONS ADMINISTERED AND ENFORCED BY THE CANADIAN FOOD INSPECTION AGENCY

1. Subsection 2(1) of the Feeds Regulations, 1983 (see footnote 1) is amended by adding the following in alphabetical order:

"ruminant" means an animal of the suborder Ruminatiae and includes an animal of the family Camelidae; (ruminant)

(a) the skull, brain, trigeminal ganglia, eyes, tonsils, spinal cord and dorsal root ganglia of cattle aged 30 months or older, and

(b) the distal ileum of cattle of all ages; (matériel à risque spécifié)

2. (1) The portion of section 11 of the Regulations before paragraph (a) is replaced by the following:

11. The Director shall refuse to register a feed if, after an assessment or evaluation of the application for registration, there are reasonable grounds to believe that

(2) Section 11 of the Regulations is amended by striking out the word "or" at the end of paragraph (e) and by adding the following after that paragraph:

(e.1) it does not conform to the requirements of the Health of Animals Act, or any regulations made under that Act, respecting animal by-products, animal food or animal products; or

12. (1) Subject to subsections (2) to (4), the Minister shall cancel a certificate of registration in respect of any feed if there are reasonable grounds to believe that there has been a contravention, with respect to that feed, of the Act, these Regulations, the Health of Animals Act or any regulations made under that Act.

4. Subsection 19(1) of the Regulations is amended by adding the following after paragraph (d):

(i) specified risk material,

(ii) cattle that died, or were condemned before slaughter for human consumption, and from which the specified risk material was not removed, or

(iii) the carcass of any other ruminant that died or was condemned before slaughter for human consumption;

(d.2) proteins in any form derived from the carcass of an animal, other than a fish, that was not raised for human consumption;

(d.3) a fat that contains more than 0.15% insoluble impurities and that is or may contain a fat of ruminant origin;

5. (1) Paragraphs 26(1)(i) and (j) of the Regulations are replaced by the following:

(i) if the feed is or contains prohibited material, as defined in subsection 162(1) of the Health of Animals Regulations, the following statement written legibly, indelibly and conspicuously:

"Feeding this product to cattle, sheep, deer or other ruminants is illegal and is subject to fines or other punishment under the Health of Animals Act./Il est interdit d'en nourrir les bœufs, moutons, cerfs et autres ruminants et des amendes ou autres peines sont prévues à cet égard par la Loi sur la santé des animaux."

(2) Section 26 of the Regulations is amended by adding the following after subsection (3):

(3.1) Subject to subsection (4), every feed that is manufactured, sold or imported shall have the name of each ingredient in the feed listed on a label attached to the feed or to a package containing it or on an invoice, shipping bill or statement delivered to the purchaser with the feed.

(3) The portion of subsection 26(4) of the Regulations before paragraph (a) is replaced by the following:

(4) Subsections (1) and (3.1) do not apply to a customer formula feed that does not contain a medicating ingredient, but the customer formula feed shall

6. Subsection 2(1) of the Fertilizers Regulations (see footnote 2) is amended by adding the following in alphabetical order:

(a) the skull, brain, trigeminal ganglia, eyes, tonsils, spinal cord and dorsal root ganglia of cattle aged 30 months or older, and

(b) the distal ileum of cattle of all ages; (matériel à risque spécifié)

8. Section 5 of the Regulations is amended by adding the following after subsection (6):

(6.1) An application for the registration of a fertilizer or supplement shall be refused if there are reasonable grounds to believe that the fertilizer or supplement does not conform to the requirements of the Health of Animals Act, or any regulations made under that Act, respecting products of a rendering plant, animal by-products, animal food or animal products.

8. (1) Subject to subsections (2) to (4), the President of the Agency shall cancel the certificate of registration in respect of any fertilizer or supplement if there are reasonable grounds to believe that with respect to that fertilizer or supplement there has been a violation of the Act or these Regulations or the Health of Animals Act, the Pest Control Products Act or any regulations made under those Acts.

10. Subsection 11(1) of the Regulations is amended by striking out the word "or" at the end of paragraph (a), by adding the word "or" at the end of paragraph (b) and by adding the following after paragraph (b):

(c) specified risk material in any form that was removed from animals or carcasses in Canada or any substance in any form that is derived from cattle that died or were condemned before slaughter for human consumption.

11. Subsection 16(1) of the Regulations is amended by striking out the word "and" at the end of paragraph (h), by adding the word "and" at the end of paragraph (i) and by adding the following after paragraph (i):

(j) in the case of a fertilizer that is or contains prohibited material, as defined in subsection 162(1) of the Health of Animals Regulations, conspicuous statements written legibly and indelibly in both official languages that indicate that

(i) feeding the product to cattle, sheep, deer or other ruminants is illegal and subject to fines or other punishment under the Health of Animals Act,

(ii) the product is not to be used on pasture land or other grazing areas for ruminants,

(iii) the product is not to be applied within three metres of a body of water,

(iv) the product is not to be ingested, and

(v) a person should wash his or her hands after the person uses the product.

12. Subsection 18(1) of the Regulations is amended by striking out the word "and" at the end of paragraph (g) and by adding the following after that paragraph:

(g.1) in the case of a supplement that is or contains prohibited material, as defined in subsection 162(1) of the Health of Animals Regulations, conspicuous statements written legibly and indelibly in both official languages that indicate that

(i) feeding the product to cattle, sheep, deer or other ruminants is illegal and subject to fines or other punishment under the Health of Animals Act,

(ii) the product is not to be used on pasture land or other grazing areas for ruminants,

(iii) the product is not to be applied within three metres of a body of water,

(iv) the product is not to be ingested, and

(v) a person should wash his or her hands after the person uses the product; and

19. (1) The definition "animal food" in section 2 of the Health of Animals Regulations (see footnote 3) is replaced by the following:

"animal food" means food containing an animal product or animal by-product for chickens, turkeys, ducks, geese, ratites, game birds, ruminants, swine or horses; (aliments pour animaux)

(2) Section 2 of the Regulations is amended by adding the following in alphabetical order:

"fertilizer" has the same meaning as in section 2 of the Fertilizers Act; (engrais)

"supplement" has the same meaning as in section 2 of the Fertilizers Act; (supplément)

6.21 (1) Every person who slaughters, cuts up or debones cattle for human consumption as food shall ensure that, immediately after removal of the specified risk material, the specified risk material is stained with a conspicuous and indelible dye and collected in a dedicated container that is marked with a statement in both official languages indicating that the contents are specified risk material and are not for use in food for humans or animals or for use in fertilizers or supplements.

(2) Subsection (1) does not apply in the case of cattle that are slaughtered, cut up or deboned on a farm or ranch, as defined in section 172, if the carcasses of those cattle are for human consumption as food on the farm or ranch and neither any of the carcasses nor any part of any of the carcasses is removed from the farm or ranch.

6.22 (1) If the specified risk material has not been removed from all or any part of the carcass of an animal that was not slaughtered for human consumption as food, the person who has the possession, care or control of the carcass or any part of it shall ensure that the entire carcass or the parts of it containing the specified risk material are stained with a conspicuous and indelible dye.

(2) Subsection (1) does not apply in respect of the carcass of an animal that dies on a farm or ranch, as defined in section 172, if neither the carcass nor any part of it is removed from the farm or ranch.

6.23 Every person who is required by these Regulations to remove or stain specified risk material or who collects the carcasses of cattle that died or that were condemned before slaughter for human consumption shall keep, for a period of seven years, a record for each day on which the specified risk material is removed or stained or the carcasses are collected that includes

(a) the person's name and address and the date of the removal, staining or collection;

(b) the combined weight of the specified risk material and the carcasses or parts of carcasses, as well as the number of carcasses;

(d) the numbers of the approved tags, as defined in section 172, that are on the carcasses or, in the case of carcasses not bearing approved tags, the information referred to in paragraph 187(2)(a) in respect of the carcasses;

(e) if the person destroyed the specified risk material or the carcasses, the date on which and the manner in which the specified risk material or the carcasses were destroyed; and

(i) the name and address of the person who received the specified risk material or carcasses for use, treatment or disposal and the manner of use, treatment or disposal,

(ii) the name and address of the person who transferred the specified risk material or the carcasses to another location for use, treatment or disposal and the manner in which the specified risk material or the carcasses were transferred, and

(iii) the name and address, if known to the person, of the person who destroyed the specified risk material or the carcasses.

6.4 (1) Except in accordance with a permit issued by the Minister under section 160, no person shall receive, remove from any premises, use, convey, treat, export or destroy specified risk material in any form, whether or not incorporated into another thing, if the specified risk material was removed from cattle slaughtered in Canada or was removed from, or is contained in, the carcasses of cattle that died or that were condemned before slaughter for human consumption.

(2) Subsection (1) does not apply to require a permit for staining under section 6.21 or 6.22.

(3) Subsection (1) does not apply in respect of specified risk material that was removed from cattle slaughtered on a farm or ranch, as defined in section 172, or that was removed from, or is contained in, the carcasses of cattle that died on a farm or ranch, if neither any of the carcasses nor any part of any of the carcasses is removed from the farm or ranch.

(4) The Minister shall not issue a permit for the purpose of subsection (1) if the specified risk material is to be received, removed from any premises, used, conveyed, treated or exported in any form, whether or not incorporated into another thing, for human consumption as food.

(5) The Minister shall not issue a permit for the destruction of specified risk material unless the destruction is to be by incineration, or another method, that will ensure that the specified risk material and anything in which it is incorporated will not be used as food for humans or animals and will not enter the environment in such a way that it could contaminate any water or food supply.

6.5 No person shall feed to any animal, or use as a fertilizer or supplement, protein in any form — whether or not incorporated into another thing — that is derived from

(b) the carcasses of any cattle that died or were condemned before slaughter for human consumption and from which the specified risk material was not removed.

22. The heading before section 46 of the Regulations is replaced by the following:

Meat and Bone Meal, Bone Meal, Blood Meal, Tankage, Feather Meal, Fish Meal, Rendering Plant Products, Animal Manure, Garbage and Ship's Refuse

23. The portion of subsection 46(1) of the Regulations before paragraph (a) is replaced by the following:

46. (1) No person shall import meat and bone meal, bone meal, blood meal, tankage (meat meal), feather meal, fish meal or any other product of a rendering plant or manure into Canada unless

24. The heading of Part VIII of the Regulations is replaced by the following:

70. (1) Subject to this Part, no person shall export out of Canada a product of a rendering plant, or a fertilizer, supplement or animal food that contains a product of a rendering plant, unless

(a) the person has obtained a certificate of an inspector or a veterinary inspector issued before shipment that clearly identifies the product of a rendering plant, fertilizer, supplement or animal food and shows

(i) that an inspector or a veterinary inspector has inspected the product of a rendering plant, fertilizer, supplement or animal food, as well as the rendering plant or the plant or mill where the fertilizer, supplement or animal food was prepared,

(ii) the date and place of the inspection, and

(iii) where tests have been performed, the nature of each test and that the product of a rendering plant, fertilizer, supplement or animal food proved negative to the tests or otherwise met the requirements of the importing country; and

(b) the importation requirements of the country to which the product of a rendering plant, fertilizer, supplement or animal food is exported have been complied with.

(2) No person shall export a product of a rendering plant or a fertilizer, supplement or animal food that contains a product of a rendering plant unless the certificate referred to in subsection (1) bears the mark of the official export stamp referred to in subsection (3).

(3) The official export stamp required by this section shall contain the words "Government of Canada — CANADIAN FOOD INSPECTION AGENCY — Gouvernement du Canada — AGENCE CANADIENNE D'INSPECTION DES ALIMENTS" and it shall be applied on a certificate only by an inspector, a veterinary inspector or a person authorized by an inspector or a veterinary inspector.

(4) No person except an inspector, a veterinary inspector or a person authorized by an inspector or a veterinary inspector shall have in his or her possession an official export stamp or any facsimile of one.

(b) on request by an inspector, during the period for which the record is to be retained under these Regulations, provide the inspector with the record for the purpose of examining it, taking extracts from it or making copies of it; and

27. (1) Subsection 160(1.1) of the Regulations is replaced by the following:

(1.1) The Minister may, subject to paragraph 37(1)(b) of the Canadian Environmental Assessment Act, issue a permit or licence required under these Regulations if the Minister is satisfied that, to the best of the Minister's knowledge and belief, the activity for which the permit or licence is issued would not, or would not be likely to, result in the introduction into Canada, the introduction into another country from Canada or the spread within Canada, of a vector, disease or toxic substance.

(2) Paragraph 160(2)(b) of the French version of the Regulations is replaced by the following:

b) renferme les conditions que le ministre juge appropriées pour empêcher l'introduction et la propagation de maladies transmissibles au Canada ou leur introduction dans tout autre pays, en provenance du Canada.

(c) failure to do so could result in the introduction into Canada, the introduction into another country from Canada or the spread within Canada, of a vector, disease or toxic substance.

162. (1) In this Part, "prohibited material" means anything that is, or that contains any, protein that originated from a mammal, other than

(c) subject to subsection (1.1), gelatin derived exclusively from hides or skins or products of gelatin derived exclusively from hides or skins;

(e) rendered fats, derived from ruminants, that contain no more than 0.15% insoluble impurities or their products.

(1.1) Paragraph (1)(c) does not apply if a hide or skin referred to in it is from the head of a ruminant.

163. (1) Every person who has the possession, care or control of a product of a rendering plant that is, or that contains any, prohibited material shall ensure that the product has been identified by a conspicuous and indelible marker or tracer substance that has been approved by the Minister and that has been added to the product to indicate that the product is or contains any prohibited material that is not legal to be fed to ruminants.

(1.1) The Minister shall base his or her decision about whether to approve a marker or tracer substance for the purpose of subsection (1) on whether

(a) the substance is sufficiently conspicuous to alert people to the presence of the prohibited material;

(b) the substance is sufficiently indelible that it will continue to identify the product until the product is consumed by animals other than ruminants or is destroyed;

(c) the substance will make the product sufficiently distinguishable from anything that has been stained to indicate the presence of specified risk material;

(f) the substance will not leave any residue in the animals that consume it in their food.

30. (1) Section 165 of the Regulations is amended by adding the following after subsection (1):

(1.1) No person who operates a rendering plant shall manufacture a prohibited material on the same premises as material not prohibited from being fed to ruminants without having dedicated manufacturing lines, equipment and conveyances to prevent the mixing or contamination of material not prohibited from being fed to ruminants with or by prohibited material.

(3) The records that are required by subsection (2) to be kept by a person who operates a rendering plant shall be kept by that person for seven years from the date the requirement arises.

(4) No person who operates a rendering plant shall distribute or sell any product of the rendering plant that contains prohibited material unless the documentation required by these Regulations relating to the product and any label on any packaging or container containing the product is marked conspicuously, legibly and indelibly with the following statement:

31. (1) The portion of subsection 166(2) of the Regulations before paragraph (a) is replaced by the following:

(2) Every person who imports or has the possession, care or control of any product of a rendering plant shall keep for seven years a record of

(c) the name, lot number and quantity of the product and any other information that is sufficient to identify the product;

166.1 (1) Every person who operates a rendering plant shall establish and maintain procedures to facilitate an effective recall of the products of the plant.

(2) Every person who imports any product of a rendering plant shall establish and maintain procedures to facilitate an effective recall of the product.

167.1 No person who operates a rendering plant or who imports or distributes prohibited material shall convey any prohibited material on the same conveyance as animal food for ruminants or material not prohibited from being fed to ruminants.

167.2 No person shall manufacture, package, label, store, distribute, sell or advertise for sale any prohibited material unless it has been heated for a period of not less than 20 minutes at a temperature of not less than 104°C and at a pressure of at least one atmosphere.

34. (1) Subsections 170(1) and (2) of the Regulations are replaced by the following:

170. (1) Every person who has the possession, care or control of any prohibited material or anything, including an animal food for equines, porcines, chickens, turkeys, ducks, geese, ratites or game birds, that contains prohibited material on the same premises as a product of a rendering plant that does not contain prohibited material or any animal food for ruminants shall have dedicated equipment to prevent the mixing or contamination of the rendering plant product, or animal food for ruminants, with or by prohibited material.

(a) ensure that the separation of rendering plant products or animal food for ruminants from the prohibited material is maintained from the time the rendering plant products or animal food is received until it leaves the person's possession, care or control; and

(b) shall keep for seven years a written record of the rendering plant products, the animal food for ruminants and the prohibited material.

(2) The portion of subsection 170(3) of the Regulations before paragraph (a) is replaced by the following:

(3) Subsection 170(3) of the Regulations is amended by striking out the word "and" at the end of paragraph (a), by adding the word "and" at the end of paragraph (b) and by adding the following after paragraph (b):

(c) the person shall recall any product or animal food that may have been destined for feeding to ruminants if the product or animal food is found to contain prohibited material.

35. (1) Paragraph 171(1)(e) of the Regulations is replaced by the following:

(e) the lot number and any other information used to identify each lot of animal food; and

(a) the name, lot number and other information used to identify the animal food;

171.1 Any person who manufactures, imports, packages, stores, distributes, sells or advertises for sale animal food containing prohibited material shall ensure that the animal food has been identified by means of a marker or tracer substance that has been approved by the Minister under subsection 163(1.1) and that has been added to the animal food to indicate that the animal food contains a prohibited material that is not legal to be fed to ruminants.

37. Subsection 2(1) of the Meat Inspection Regulations, 1990 (see footnote 4) is amended by adding the following in alphabetical order:

(a) the skull, brain, trigeminal ganglia, eyes, tonsils, spinal cord and dorsal root ganglia of cattle aged 30 months or older, and

(b) the distal ileum of cattle of all ages; (matériel à risque spécifié)

38. (1) The portion of subsection 3(1) of the Regulations before paragraph (a) is replaced by the following:

3. (1) Subject to subsection (1.1), sections 7 to 9 of the Act do not apply in respect of

(2) Section 3 of the Regulations is amended by adding the following after subsection (1):

(1.1) Paragraphs (1)(a), (d), (d.1), (g) to (i), (k) and (l) do not apply to anything referred to in those paragraphs that is, that contains or that is derived from specified risk material in any form that originated in a country other than a country that is designated under section 7 of the Health of Animals Regulations as being free from Bovine Spongiform Encephalopathy.

39. Subsection 26(1) of the Regulations is amended by adding the following after paragraph (a):

(a.1) it is not derived from, and does not contain, specified risk material in any form, whether or not incorporated into another thing;

40. The portion of subsection 54(1) of the Regulations before paragraph (a) is replaced by the following:

54. (1) Every meat product that is condemned in a registered establishment — other than a condemned meat product sent by an inspector for laboratory examination, a meat product that contains specified risk material in any form, whether or not incorporated into another thing, or a meat product referred to in subsection 85(2) — shall be identified as condemned, conveyed immediately to the inedible products area of the establishment and

41. These Regulations come into force on the day on which they are registered.