Canada's Response to European Commission Mission Carried out to Evaluate the Control of Residues in Live Animals and Animal Products

December 15, 2000

Table of Contents

1. Overview

2. General Comments

3. Action Plan

1. Overview

Food Safety is of paramount importance

Ensuring the health and safety of our citizens is of paramount importance to the Canadian Government. In this regard, Canada and the European Union (EU) share the same objective of providing the highest level of health protection through our respective food safety policies, standards, and inspection and control systems.

The Canadian agriculture and agri-food industry has a positive reputation world wide, and our food safety inspection and control system has served consumers of Canadian products well. Canada's goal is to continue to be a leader in food safety and food quality by having a national, comprehensive and coordinated plan among governments and industry. Work is ongoing with provinces, and territories commodity groups and other stakeholders in the food chain to address emerging food safety issues. By continuing to improve regulatory, enforcement, prevention and control processes Canada will remain a world leader in food safety and consumer protection.

It is recognized that market access into other countries requires that Canada be responsive to evolving requirements in export markets and be vigilant in the integrity of its inspection and certification programs. Canada is firmly committed to the continuous improvement of its food safety and public health system which forms the foundation for the positive reputation of our products that has been well deserved over the past number of years.

Governance

Food regulation and inspection in Canada is a shared jurisdictional responsibility. Federal, provincial and territorial governments continue to work within a food safety framework that was agreed to in 1996. Part of the framework was the creation of a single food inspection agency, the Canadian Food Inspection Agency (CFIA) in 1997. This brought together the inspection programs and services provided for food safety, animal, fish and plant health that were previously provided by a number of federal departments. In the food safety area, CFIA and Health Canada (HC) share responsibility. HC maintains the policy and food safety standard setting role. This allows for independent enforcement of rules set by HC and is further strengthened by HC's assessment of the effectiveness of CFIA's food safety activities. Since its formation, the CFIA has enhanced its capacity and focus on food safety. The CFIA has increasingly emphasized protection of consumers from health hazards associated with food, product misrepresentation and fraud.

Having the world's best and most responsive food safety and control system

The Government of Canada's ongoing commitment to the citizens of Canada was restated in the Speech from the Throne of October 1999 where it declared that safe food is fundamental to health. Through the ongoing initiatives to upgrade regulatory, enforcement, prevention and control processes Canada will continue to have one of the world's best and most responsive food safety and control systems. This integrated approach to food safety is being pursued through initiatives with the Canadian industry to develop on-farm food safety programs to enhance monitoring and control of food safety hazards and to encourage the application of HACCP principles throughout the food continuum. Provincial and territorial governments are also a key part of the integration efforts, and they participate actively in this regard to improve science programs, surveillance capabilities, and regulatory and related responsibilities.

Investing in science

Most recently, as part of its commitment to improve Canadians' health, the Government of Canada has invested in strengthening the national system of scientific support for food safety and nutrition, and is developing new food safety and nutrition policies and initiatives in consultation with Canadians.

Canada's commitment to the furthering of food safety standards is also evident in the strong role that Canada plays in the various international fora that set these standards, including in the Committees of Codex Alimentarius that seeks to develop and promote the adoption of scientifically based food safety standards.

Canada seeks continuous improvement

The Canadian government recognizes that continuous improvement beyond those initiatives underway is needed for Canada to achieve its objective of providing citizens and consumers of Canadian products with the highest degree of assurance regarding safety and quality of our food products. In this regard, a more integrated approach to food safety and environmental risks, based on a coordinated national strategy must be a high priority. This will be achieved through our joint governance model already established with provinces and territories in a number of areas which cross shared and unique jurisdictions. The Canadian government's long-term objective is to ensure that Canada maintains its leading position in setting standards for food safety and environmental protection in the agriculture and agri-food sector.

Planned initiatives for Canada include more federal/provincial/territorial collaboration to manage domestic and international food safety strategies. Fully implementing trace-back systems, increasing levels of testing, and emphasizing research for re-evaluation of compounds are some of the initiatives that will be undertaken.

Context of the EC Audit

EC regulatory auditors (Food and Veterinary Office (FVO), Health and Consumer Protection Directorate-General (SANCO)) visited Canada from September 19-29, 2000 to evaluate the control of veterinary drug residues in live animals and animal products for purposes of Canada's exports of these products to the EU. This undertaking was not the result of any products imported into the EU from Canada having been found to be in violation of the established standards. Rather, the visit was undertaken as part of the FVO's cycle of planned missions to all countries which export products to the EU. This was the second mission undertaken to Canada in this area, the first having been carried out in May 1998. During the visit, the EC auditors met with HC and CFIA officials and visited laboratories, farms, slaughterhouses and feedlots. The standards used for the evaluation were EU Council Directives and other applicable Community legislation as well as Canadian legislation and regulations. In Canada, the federal legislative authority for regulating the approval, sale and labelling of veterinary drugs is the responsibility of HC. CFIA is responsible for enforcing the health and safety standards set by HC. In the case of veterinary drugs, this is done through the residue monitoring program and, specifically, sampling and testing of food products of animal origin. The authority and accountability for the prescribing and use of veterinary drugs falls under provincial and territorial jurisdiction.

Since the audit report was received by Canada on October 19, 2000, Canadian and EC officials have engaged in a series of productive and positive technical discussions. From a Canadian perspective, this provided an opportunity to clarify and narrow key EC concerns. The Canadian response to the EC draft audit report is a detailed and serious effort to correct factual errors, to clarify the regulatory approach in Canada, and to develop a mutually agreeable action plan.

The attached comprehensive action plan addresses, among other things, the four areas of key concern to the EC. These include: 1) ensuring a national approach for the effective control of extra label use of veterinary drugs; 2) broadening the ban on the use of diethylstilbesterol (DES) in food producing animals and banning the sale of other drugs found on evaluation of new scientific evidence, to pose a risk to human health; 3) establishing legal limits for all veterinary drug residues under the authority of the Food and Drugs Act; and 4) implementing a mutually agreed sampling and testing program for food products of animal origin.

Canada's overall objective in responding to the EC audit is to improve our food safety and control system in areas where concerns have been identified, and to demonstrate Canada's commitment to providing mutually acceptable measures to ensure the equivalence of our two systems, and to allow for continued trade with the EU. The action plan has been designed to provide Canadian consumers and our trading partners with additional levels of assurances regarding the integrity and effectiveness of Canada's overall food safety and animal health systems. In providing this response, Canada contends that the conclusions and recommendations as drafted in the October 19, 2000 FVO report should be revised prior to publication of the final SANCO report.

Within the context of achieving the desired level of consumer health protection, Canada also supports the concept of recognition of equivalency of inspection and control systems where the appropriate level of protection can be achieved through different regulatory systems or structures. Canada and the EU signed a Veterinary Agreement in December 1998. It covers animal and public health and safety issues related to trade in live animals, animal products, fish and fish products between the EU and Canada. The Agreement features a framework for working toward equivalency, the aim of which is to recognize that Canada and the EU both have well developed, but different, food safety and animal health systems which offer equivalent levels of protection. Veterinary drug residues are not presently covered by the Agreement. This was noted as an area for consideration at the Canada-EC Veterinary Agreement Joint Management Committee's meeting in October 2000. The EC draft audit report also recommends that this area be taken into account in future discussions under the Canada-EU Veterinary Agreement. Canada would welcome the opportunity to further this discussion on equivalency of veterinary drug measures.

Consumers benefit from the audit process

Canada welcomes audits as they are part of an ongoing process trading partners undertake to respond to consumers' needs for assurances regarding the safety of their food supply. Canada receives audits from the EC and other countries that we export to, and conducts audits on the EC and other countries that export products to Canada. Canada believes that audits are helpful in that they identify new and emerging concerns and allow for countries to continuously improve their food safety inspection and control systems. Canada recognizes that, ultimately, it is the consumer who benefits from this process.

2. General Comments

We would request that the observations made in the draft report be reviewed and consideration be given to revising certain statements that, as made, produce a perception in the reader that the Canadian residue control program is less than it is in reality. An example is the last paragraph of Section 5.4.3 where the report speculates on what could happen if certain drugs were available as implants. Since these drugs are not available in Canada as implants this statement should be removed.

Paragraphs 2 and 3 of Section 5.9 cite laboratory suspensions in Canada by the USA and CFIA. These paragraphs have, in our view, an unnecessary negative connotation that has no direct relevance to any conclusion made.

5.2.3.1
Paragraph 4

"In the monitoring sampling regime, animals sampled are not detained pending the result of the examination."

This is a misleading statement. In a monitoring sampling regime not detaining sampled animals is, in fact, in accordance with CODEX criteria and a normal procedure.

5.2.4
Paragraph 4, last sentence.

"No satisfactory explanation of the omission was provided"

These samples were not included because they were not reported in time for inclusion in that year. They will be included in the 1999/2000 report.

5.2.5
Last sentence

"There are no procedures for follow up investigations at farm/feedlot level"

In reality procedures for follow up investigations relating to evidence of drug use at slaughter are carried out under the Animal Health and Feed Programs. Procedures for follow up for those two programs can be found in the respective manuals of procedures for those two programs.

5.3
Paragraph 4

Delete the second sentence to the end of the paragraph because it contains commercially confidential information.

5.4.2

Notwithstanding current provisions for the use of HGP's, Health Canada will be evaluating new scientific evidence that has become available relating to these hormonal products and will take action as appropriate based on the findings.

5.4.3
Paragraph 2

"Among these non-prescription drugs, which are freely available and can be sold over the counter to farmers and feedlot owners are the following substances which have been banned for use in food producing animals in the EU: chlorpromazine, furaltadone, furazolidone, nitrofurantoin, and ronidazole. These over the counter drugs can be legally subject to "extra-label" use of farmers and feedlot operators."

This is a misconception. Furaltadone, furazolidone and nitrofurantoin are banned for use in food producing animals under Sections B.01.048 and C.01.610.1 of the Food and Drug Regulations, and chlorpromazine and ronidazole are not sold in Canada.

Paragraph 4

"Most of the anabolic steroids are exempt from Schedule F. In general, these steroids are subject to the Controlled Drugs and Substances Act and Part G of the Food and Drugs Act and Regulations. However, if such a "controlled drug" is contained in an "agricultural implant" in the meaning of Section G.01.001 the restrictive regulations of the above regulations do not apply (Section G.01.004). Consequently, implants containing methyltestosterone, boldenone, stanozolole or any other of the 43 steroids listed in the Schedule of Part G of the Food and Drugs Act and Regulations could be legally applied, if available as implants in Canada."

Steroids listed in the Schedule of Part G of Food and Drugs Act and Regulations could be legally applied, only if available as implants in Canada. However, implants containing methyltestosterone, boldenone and stanozolole are not sold in Canada.

5.4.4

Any drugs that are used as feed additives can only be used on-farm in accordance with the Medicating Ingredients Brochures (MIB) published by the CFIA on the basis of issuance of Notices of Compliance for drugs by the Veterinary Drugs Directorate of Health Canada. The MIB contains information on the approved brands of veterinary drugs, approved form of the medicated feed, approved claims, level of the drug in feed, directions for use, warning statement for the withdrawal of the medicated feed before slaughter or the withholding period for milk and the cautionary statement related to animal safety.

A veterinary prescription is required for a medicating feed ingredient that is to be used at levels that differ from the MIB. A veterinary practitioner may write a prescription for a drug or drugs to be mixed in feeds as stipulated in Section C.08.012 of the Food and Drug Regulations. According to this Section of the regulation, the drug must be assigned a drug identification number (DIN) by Health Canada and the medicated feed is for therapeutic use only. The written prescription contains information about the name and address of the person for whom the medicated feed is to be mixed; the species, production type, age or weight of the animal to be treated under the direct care of the veterinary practitioner who signed the prescription, the type and the amount of the medicated feed to be mixed; the proper name of the drug and the dosage levels, any special mixing instructions and the labelling instructions including the feeding instructions, a warning statement respecting the withdrawal period to be observed following the use of the medicated feed and where applicable, cautions with respect to animal health or to the handling or storage of the medicated feed.

A copy of the veterinary prescription is retained by Feed Mills where the medicated feed has been prepared.

Antibiotics have been used for over half a century in livestock production for the purposes of prevention and treatment of diseases as well as for improving animal productivity. Canada shares the EU concern about the possible contribution of these antibiotics to the development of resistant bacteria that may be harmful to human health. In this connection, Health Canada has taken a pro-active role for a number of years and is consulting with its stakeholders as well as reviewing actions that are recommended by the World Health Organization as well as those proposed by other regulatory agencies e.g, Australia, EU, USA etc. The development of an evidence-based and comprehensive regulatory policy on antimicrobial resistance is a priority for Health Canada. In this regard the Department is also working with stakeholders for developing prudent use guidelines to combat the development of antimicrobial resistance. Certain antibiotics (e.g., erythromycin) that were once approved for sale for growth promotion are no longer sold in Canada for use in animal feed. Health Canada will continue and enhance existing efforts by undertaking the following actions (that are included in the action plan):

• to assess risks of antimicrobial resistance and proceed with actions, if necessary
• to review the latest data on antibiotics involving production improvement claims
• to review therapeutic efficacy claims for antibiotics.

Based on this review, Health Canada will take appropriate regulatory action where there is evidence of undue risk to human health from the use of the antibiotic product. Also, appropriate regulatory action shall be considered where based on new scientific evidence, the claims specified on the label are not proven.

5.4.4
Paragraph 2

"In the case of carbadox, which is freely available as a medicating ingredient, the compound has been banned in the EU because of its well-established carcinogenic properties. Indeed, during the course of the mission, CFIA was forced to issue a food recall of pork (125 animals) which had been contaminated with carbadox residues. This recall was only possible because of the prompt action of a private veterinarian who alerted the authorities to the fact that the pigs had been given the wrong feed in error."

This contains misleading statements. In the second sentence delete 'Indeed', and replace 'was forced to issue' with 'demonstrated control of potential residue situations by working with the abattoir that recognized the need to'. In the third sentence delete the word 'only'.

5.4.5

"The Food and Drug Act and Regulations give no clear definition of "extra-label use". Hence it remains unclear as to whether the extra-label use of veterinary drugs (including hormonal growth promoters) is restricted to veterinarian practitioners only."

Canada does have a policy on the extra-label use (ELU) of veterinary drugs which has been provided to Commission officials. This policy recommends that extra label drug use be performed under the supervision of a veterinarian with an established veterinarian/client/patient relationship. Furthermore, extra label drug use should be restricted to therapeutic purposes only where no other therapy exists. Extra label drug use may be used in food producing animals provided that appropriate withdrawal times and safety standards are established. This ELU must not result in illegal levels of drug residues in animals sent to slaughter.

The audit report does not provide evidence that ELU of prescription drugs was observed, or whether assumptions are being made on the basis of finding the compounds or their containers on site. The drug Enrofloxacin (Baytril) is not approved for direct administration to food producing animals in Canada. It is approved for sale under veterinary prescription for use in dogs and cats only.

Canada allows HFC and non-HFC on the same premises, with appropriate separation. Appropriate records (purchase and use) must be maintained and segregation between eligible and ineligible animals must be maintained to the satisfaction of the accredited veterinarian.

To clarify and strengthen controls on ELU, Health Canada is undertaking a series of actions divided in three parts (as described in the Action Plan):

• Update survey of veterinary practitioners and livestock producers associations on ELU; expedite risk assessment of specified drugs and where appropriate restrict the sale to veterinarians only; and expand human safety risk assessment to include horses.

• Enhance the control of ELU through the combined force and impact of federal and provincial legal and regulatory frameworks and strengthened partnerships.

• Enhance the educational program for veterinarians and livestock producers associations on ELU in Canada.

5.5
Paragraphs 3, 4, 5

"Despite the clear provisions in the Food and Drug Act and Regulations on the general zero tolerance with certain well-defined exemptions (see MRL regulations above), the Canadian authorities had applied for years so-called "administrative action levels" for certain substances not listed in the Food and Drug Regulations e.g. HGPs, carbadox and oxytetracycline. Examples of these levels are as follows:

View Administrative Action Levels Table
(This will open in a new window with a file size of 3 K )
(You may have to use the scroll bar to see the entire table)

By applying these administrative action levels, it was possible for meat from veal calves treated with HGPs via extra-label use, and containing residues below these administrative action levels, to enter the food chain. This anomalous issue was raised during the last FVO mission in 1998. In the meantime CFIA has taken legal advice on this issue and has confirmed that the application of administrative action levels was untenable in law in that it was inconsistent with the Food and Drug Act. CFIA stated that it would now apply a zero tolerance for all these compounds.

Despite repeated requests for documentary proof of the policy shift, the inspection team received no evidence of whether CFIA inspectors were made aware of the change in policy, or when this occurred. This is importance since regional CFIA inspectors in the federally approved slaughterhouses are charged with condemning carcases on the basis of violative residue concentrations."

This text and table associated with it are irrelevant because Canada has not applied "Administrative Action Levels" for food of animal origin since 1998 and, therefore, should be deleted.

Paragraph 8

Section C.08.002.3 (d) of the Food and Drug Regulations stipulates that the manufacturer of a new drug submit any additional information or material respecting the safety and effectiveness of the new drug which would include reference standards of marker residue for use by the official residue control laboratory. In this connection, in accordance with Health Canada's modified Standard Operating Procedures (SOPs), CFIA laboratories are provided with information on MRL's, marker residues, target tissue, analytical methodology and necessary analytical standards.

5.7

In the HFC program, the owner must record the use and purchase of HGPs in accordance with Canadian requirements. The use of HGPs must be declared at the time of enrollment.

The HFC program provides for the registration of animals. Owners must keep a register if tags are used. In the event that an animal is implanted the tag must be removed prior to implantation and this must be recorded in the inventory of tags.

In general no major changes were made to the HF program. Minor changes made were to improve the program and to reflect the reality of the field situation based on experience gained in the first year of implementation. Changes were also made to include urine sampling as requested by the EC in the previous mission. An accreditation manual was developed to provide direction to the accredited veterinarians who perform the on-farm work. Canada does not believe consultation was warranted for these minor changes.

CFIA does undertake testing of animal tissue in support of the hormone free beef program. To date there have been no positives found either by the Canadian authorities or the European countries.

Paragraph 2

"CFIA had revised the HFC programme this year without prior consultation with the Commission. Although the intention obviously was to reinforce the programme as requested in the previous FVO mission report, the revised programme was not extended to buffalo as recommended in the previous report."

This paragraph is misleading. The previous report indicates '... program might be implemented for buffalo meat ...'.

Paragraph 12

The feedlot on which the hormonal growth promotants were noted only has feedlot cattle which are not implanted with HGPs . Both during the mission and during subsequent discussions the owner confirmed that HGPs had been used prior to entering the Hormone Free Program , and that the remaining implants had not been disposed of. Again, during the mission, the owner 's statements were confirmed by provision of invoices for the purchase of the implants prior to entering the HF Program.

Physical inspection of cattle: It is not practical to require the palpation of all animals. Canadian guidelines indicate at least 10% of the animals should be examined. The veterinarian makes an overall assessment of the animals and examines as deemed appropriate.

Procedures at the slaughterhouse: In Canada's perspective the veterinarian in charge had control over this process and traceability could be demonstrated.

5.9
Paragraphs 2, 3

These paragraphs should be deleted. They are written in a way that creates a negative perception. Alternatively the statements could be revised to 'Canada has demonstrated diligence in ensuring that analyses are performed only by laboratories with the appropriate capabilities.'

Paragraph 4
First sentence

"Following the last FVO mission in May 1998, there was a commitment from CFIA that all testing for HGPs and beta-agonists would be carried out in federal laboratories with proficiency samples sufficient for those programmes."

This is not entirely correct. Canada's intention was for all testing related to the hormone free program to be carried out in federal labs, and all testing, regardless of program, to be performed in accredited labs. This has been implemented.

5.9.1
Paragraph 2

In the first sentence replace 'claimed' with 'stated'.

Validation of the beta-agonist method for analysis of retina and liver tissues was completed, with final method approval September 15, 2000. Based on literature and discussions with other experts, it was determined that retina was the best test substance for detection of use of beta-agonists, followed by liver. Residues are only reliably detectable in urine for several days after treatment of an animal. The method is now being extended to urine, but the inspectors should be aware that this could not be accomplished in the week between completion of the tissue validation and their visit to the laboratory.

Paragraph 5

Bullets 2, 3, 4 and 5 are inaccurate, while bullet 1 is a technicality. These statements should be deleted. The final report did not contain explicit emphasis on items as claimed in bullets 2, 3, and 4. Also, the five "serious deficiencies" as listed are misleading and reflect technical differences of opinion, not issues of competency or quality.

Bullet 1: The auditors noted that an SOP for validation of test kits approved in November, 1996, had not been applied retroactively to methods which had been in use for years prior to development of the protocol. The laboratory has extensive on-going QC data on these methods which exceeds the requirements of the validation protocol. Documents are being revised to state that such SOP's do not apply retroactively, unless so stated.

Bullet 2: The existing DES/zeranol method was undertaken to extend this method to include hexoestrol and dienoestrol. The validation runs were complete at the time of the visit. Statistical analysis of the data to determine performance characteristics of the method, writing the validation report and revision of the protocol are in progress, with expected completion time for this work in 4-6 weeks.

Bullet 3: Canada's action plan developed in response to the1998 audit did not include a commitment to discontinue use of nortestosterone as an internal standard in the trenbolone method. This issue only relates to the reliability of quantitation for trenbolone, as the method has not been used for detection of nortestosterone residues. Since we are currently enforcing a zero tolerance for trenbolone, quantitation is not critical to the integrity of the program. A validated method for trenbolone which does not use nortestosterone as internal standard has been used for in a research project and will be adopted for routine use. Estimated time to train an analyst and implement the method is 3-6 weeks.

Bullet 4: There was no specific reference to the inclusion of taleranol in the zeranol/DES method in the final report of the 1998 mission report. Administrative action levels established in Canada and Codex MRLs are expressed in terms of parent zeranol and this was the residue identified in the method. However we can accept the recommendation as the current method will determine taleranol without modification, as zeranol and taleranol are chromatographically resolved and the same ions can be monitored for both compounds. A data set to establish performance characteristics will be generated and the method will be modified accordingly after method extension to urine has been completed.

Bullet 5: The statement that data checked by the auditors revealed traces of trans-DES is wrong. The auditor chose to place his own interpretation on the data, rather than to accept that of the CVDR analyst. DES is expected to be present in the forms of both cis- and trans- isomers, both of which are detected as ion fragments at mass/charge ratios of 383, 397 and 412. The "trace" peak identified by the auditor is an interference peak, as demonstrated by the ion ratios observed. The ion ratio for 383/412 should be 20%, but in these samples was over 100%, an impossible situation for a real incurred sample. CVDR applies criteria for mass spectral confirmation similar to those recommended by EU experts and the USFDA which both recommend that multiple characteristic ion fragments, in ratios consistent with those found for standards, must be present to confirm a positive finding. The data seen by the auditor did not approach this requirement.

5.9.2
Paragraph 3

Storage and security of samples have already been addressed.

Paragraph 4

Please qualify the first sentence with evidence, and provide criteria for the assessment of analytical experience, or delete this sentence. Personnel in private laboratories are required to follow methodology which is provided to them by the CFIA, and are not required to assess methodology. Delete the second sentence.

6.2

The Canadian approach, although not similar from a legal perspective to the European Union's prescriptive preference, does provide for a comparable level of consumer protection. Canada formulates laws in a way deemed appropriate for the Canadian public. The fact that Canada does not prescribe specific laws to deal with mandatory residue controls for food commodities of animal origin or live animals in no way limits authority to adequately respond to such a need. The fact that Canada has a very comprehensive and effective residue control program in place confirms this point. Canada derives authority for policy making in this regard from the Food and Drugs Act, which refers to the adulteration of food. Authority with respect to live animals is well established in the Health of Animals Act.

The Meat Inspection Regulations do provide authority for the antemortem inspection of animals prior to slaughter, and where there is suspicion about the use of drugs or inappropriate withdrawal times, authority exists to investigate and/or withhold/condemn the animal/carcass at slaughter.

On August 1, 2000, the Canadian Food Inspection Agency (CFIA) initiated a raw milk sampling program for milk in the dairy program to supplement the ongoing raw milk programs being carried out by provincial authorities. CFIA recognized the need to enhance the federal program to include residues of veterinary drugs and agro-chemicals not covered by provincial testing activities. The CFIA program also continues to test for specific residues in finished products.

CFIA recognizes the need to enhance testing activities in some areas to more fully achieve the international (CODEX) standards. We believe that such an enhancement will permit the CFIA to provide additional assurances that the Canadian food supply is safe.

CFIA further believes that the random monitoring component in the Canadian plan allows for the actual calculation of risk in the food supply, while the approach favoured by the EU will be effective only in situations where the likely violators are known to regulators in advance.

CFIA does not hold animals merely because samples have been taken from them unless there is a reasonable basis to suspect that the animals are violative. This is fully consistent with the Codex Guidelines for the Establishment of a Regulatory Program for the Control of Veterinary Drugs (CAC/GL 16-1993).

CFIA continues to update and modernize a number of its computer-based data management systems. Although reports requested by the EU auditors could not be immediately provided, this does not justify the sweeping statement that the system is non-operational. CFIA undertook a major Y2K upgrade in late 1999, and these systems continue to be refined. A summary report is available, however, it requires retrieval of archived data.

6.3

CFIA enters farms to investigate residue violations. The Feeds Act allows inspectors to enter farms to investigate a drug residue that could have resulted from illegal feeding of medicated feeds. If an owner refuses to cooperate in an investigation where the residue is not associated with a feed but poses a threat to public health, CFIA works cooperatively with Medical Officers of Health who can use provincial legislation to deal with the residue problem, including entry onto farms.

In addition, CFIA is currently in the final stages of approving Medicated Feed Regulations that will increase the powers to deal with medicated feed manufacturing which includes on-farm activities.

CFIA also has provisions in the Health of Animals Act that would allow better control of toxic substances, including drug residues in live animals and their products at the farm level. Inspectors could enter farms whereon animals were suspected of being contaminated.

The Health of Animals Act provides inspectors the power to enter any place, stop any vehicle, open any container, examine any animal or thing and take samples, require documents to be produced, conduct any test, and access any data processing system for the purpose of detecting toxic substances or ensuring compliance with any of the requirements of the Act.

The Health of Animals Act requires that toxic substances be prescribed in regulation by the Minister of Agriculture and Agri-Food. CFIA intends to propose a regulation to prescribe appropriate substances during the coming year.

6.4

The Food and Drug Regulations ( Part B, Section B.014.017) prohibit the sale of meat for consumption as food from animals treated with diethlystilbesterol (DES) as a growth promotant. This regulatory provision achieves the same result as regulations in the EU as laws in both jurisdictions are intended to prevent meat with residues of DES from reaching the public. DES is approved for sale in Canada under a veterinarian prescription for use only in dogs and cats in the form of a one mg tablet. Since the recommended dose of DES for growth promotion in cattle is 10 mg per head per day it would not be practical for administration to farm animals for a long period of time. Stilbenes are not approved for sale in Canada. Over 25,000 samples of domestically produced bovine, ovine, equine and porcine tissues have been tested for DES over a 20 year period and none of these samples were found positive for this drug. To alleviate any further concern, Health Canada has initiated two additional regulatory actions that are included in the action plan of this report.

A number of drugs that are banned for use in food animals in the EU (eg., clenbuterol and nitrofurans) are also prohibited under Section C.01.610.1 of the Food and Drug Regulations from sale for use in food-producing animals in Canada. In addition, Section B.01.048 of the Food and Drug Regulations prohibits the sale of animals for consumption which have been treated with these drugs as well as the meat and meat products, eggs and milk from these animals. Other drugs are the subject of a regulatory proposal which would ban their use in food-producing animals in Canada (dimetridazole and ronidazole) and others are not approved for sale in Canada (e.g.other beta agonists, dapson, thyrostats, chlorpromazine, colchicin, aristolchia spp.). The sale of chloroform is limited to topical medications only. The sale of carbadox is permitted for specified conditions in swine with a 35 day withdrawal time. The status of carbadox is currently under review by Health Canada and appropriate regulatory action will be taken based on the outcome of the review.

The extra-label use of veterinary drugs in Canada is guided by the Veterinary Drugs Directorate Policy (published in Journal of Am. Vet. Med. Ass. Vol. 202, No. 10, May 10, 1993), a copy of which was hand delivered on November 14 -15, 2000. ELU is practised by veterinarians all over the world to treat diseases and reduce suffering in animals under their professional care. In Canada ELU is a complex multi-jurisdictional issue involving the various provinces and territories. In this connection, as noted under Section 5.4.5, Health Canada is undertaking further actions as described in the action plan.

Antibiotics have been used for over half a century in livestock production for the purposes of prevention and treatment of diseases as well as for improving animal productivity. Canada shares the EU concern about the possible contribution of these antibiotics to the development of resistant bacteria that may be harmful to human health. In this connection, Health Canada has taken a pro-active role for a number of years and is consulting with its stakeholders as well as reviewing actions that are recommended by the World Health Organization as well as those proposed by other regulatory agencies, e.g. Australia, EU, USA etc. The development of an evidence-based and comprehensive regulatory policy on antimicrobial resistance is a priority for Health Canada. In this regard the Department is also working with stakeholders for developing prudent use guidelines to combat the development of antimicrobial resistance. Certain antibiotics (e.g. erythromycin) that were once approved for sale for growth promotion are no longer sold in Canada for use in animal feed. Health Canada will continue and enhance existing efforts by undertaking actions that are included in the action plan.

6.5

The "Administrative Action Levels" were developed using a scientific assessment process and, prior to the 1998 audit, were applied in the same manner as MRLs. Notwithstanding this, the Agency decided, following the 1998 audit by the EU, to apply a zero tolerance.

Maximum Residue Limits (MRLs) established by Health Canada for veterinary drug residues in food are listed in Table III of Division 15 Part B of the Food and Drug Regulations. At present, this Table contains MRLs for 37 veterinary drug entities. Regulatory amendment, adding another 13 drug entities plus 3 MRLs for the existing entities was published on September 16, 2000 in Canada Gazette Part I. No comments were received at the end of the one month comment period, hence these sixteen MRLs will soon be included in Canada Gazette Part II, and they will then be added to Table III. Additional regulatory amendments to Table III are considered to be a high priority by Health Canada and milestones for these are included in the action plan.

6.6

"Canadian legislation does not require records to be kept on the farms/feedlots with the identification of the treated animal, the veterinary drug prescribed and the withdrawal period for the products."

Any drugs that are used as feed additives can only be used on-farm in accordance with the Medicating Ingredients Brochures (MIB) published by the CFIA on the basis of issuance of Notices of Compliance for drugs by the Veterinary Drugs Directorate of Health Canada. The MIB contains information on the approved brands of veterinary drugs, approved form of the medicated feed, approved claims, level of the drug in feed, directions for use, warning statement for the withdrawal of the medicated feed before slaughter or the withholding period for milk and the cautionary statement related to animal safety.

A veterinary prescription is required for a medicating feed ingredient that is to be used at levels that differ from the MIB. A veterinary practitioner may write a prescription for a drug or drugs to be mixed in feeds as stipulated in Section C.08.012 of the Food and Drug Regulations. According to this Section of the regulation, the drug must be assigned a drug identification number (DIN) by Health Canada and the medicated feed is for therapeutic use only. The written prescription contains information about the name and address of the person for whom the medicated feed is to be mixed; the species, production type, age or weight of the animal to be treated under the direct care of the veterinary practitioner who signed the prescription, the type and the amount of the medicated feed to be mixed; the proper name of the drug and the dosage levels, any special mixing instructions and the labelling instructions including the feeding instructions, a warning statement respecting the withdrawal period to be observed following the use of the medicated feed and where applicable, cautions with respect to animal health or to the handling or storage of the medicated feed.

A copy of the veterinary prescription is retained by the Feed Mill where the medicated feed has been prepared.

Provinces have established in legislation, standards of practice which require that veterinarians keep appropriate records concerning contact with clients and their recommendations for use of drugs.

At the farm/producer level, national producer quality assurance programs are in place, or are being put in place, to ensure that proper drug use practices are followed and that appropriate records are kept to permit certification of produce from farm/feedlot facilities.

6.7

CFIA does test animal tissue in support of the hormone-free beef program. To date neither Canadian authorities nor European countries have found positives.

It is not clear whether the auditors witnessed extra label use of prescription drugs, or whether an assumption was made on the basis of finding the compounds or their containers on-site.

There was a planned, temporary interruption of testing for renovations and Year 2000 in December 1999. Following the renovations and software upgrades to the GC/MS used in the project, work resumed in early March. When problems were encountered in duplicating results of previous work, testing was temporarily suspended and troubleshooting commenced. It was determined that the equipment no longer had sufficient analytical sensitivity to detect the hormones at the target concentrations. Work was transferred to another instrument and method development and validation on this instrument is continuing. Current plans are for extension and validation of the following tissue methods to urine.

6.9

This statement is correct. Urine is not routinely collected as part of the Canadian residue control program. The program focusses on edible tissue, using the target tissue/marker residue concepts found in Codex and other sources. Urine testing is a part of the Hormone Free Cattle (HFC) program. Following the audit in May 1998, CFIA committed to establishing a project for the development and validation of analytical methodology for compounds listed in the HFC Agreement with the EU. This research project was formally established April 1, 1999, although preliminary work began immediately following the audit.

The CFIA's Centre for Veterinary Drug Residues (CVDR) has committed to validating existing methods, after suitable methodology revisions have been made, for trenbolone, nortestosterone, zeranol, stilbenes, and beta-agonists in urine. These methods will then be added to CVDR's scope of accreditation for its next scheduled audit. In the meantime, work conducted with such methods is within the scope of our accreditation for Test Development and Non-Routine Testing. Once these methods have been validated, the testing can be made available for accreditation of private laboratories.

There was no specific reference in the May 1998 report to major deficiencies, except for one observation to which Canada responded with the commitment to establish a project for the development and evaluation of analytical methodology listed in the HFC Agreement. Action was initiated immediately after the audit, and the research project was formally established by April 1, 1999.

Canada relies on established analytical methods that have been fully validated for the intended purpose. The accreditation includes assessment of the ability of both the laboratory and the analyst to perform the test to the standards prescribed in the method.

As a result, analytical methods, once validated and accredited, may be implemented in any accredited laboratory regardless of the specific experience of the analyst. The Standards Council of Canada accreditation assures that the laboratory and the analyst are competent. CFIA does not contract out experimental techniques but only well-founded analytical procedures.

In those few cases where non-validated methods must be employed for a short period of time because of an emergency or evolving nature of a problem, the task is assigned to senior analysts well qualified for the situation.

While the Centre for Veterinary Drug Residues (CVDR) does not perform all the designated functions of a reference laboratory as per EU directives and practices, the CFIA approach of shared responsibility between program and laboratory staff is equivalent to EU practices.

CFIA has an agreement with the Standards Council of Canada for the program speciality area - Agriculture and Food. Contract and CFIA labs are expected to be accredited under the program speciality area if they are performing regulatory analyses.

CVDR has provided chemists to conduct technical assessments of private laboratories contracted by the CFIA to do residue analyses. Five visits, involving two different staff, were conducted in 1999.

In addition, CVDR provides proficiency samples to the contract lab. In the last three years, samples have been provided in chloramphenicol and trenbolone. As part of the agreement with Canada's accrediting body, the Standards Council of Canada, CVDR provides, on an ongoing basis, proficiency test samples to support accreditation of CFIA and contract labs in the following areas: sulfonamides (program jointly organized with the Food Safety and Inspection Service of the U.S. Department of Agriculture), organochlorine pesticides, and chlorinated phenols.

In addition, technical support is provided to contract laboratories upon request. This includes distribution of methods, troubleshooting, and assisting the laboratories in obtaining analytical standards.

6.10

Canada is of the view that there is no basis for the sweeping nature of these conclusions. The information provided throughout this document and the reality of the current conditions in Canada demonstrate that although improvements can be made in some areas, Canada's record of residue control is excellent. Deficiencies pointed out in the audit appear to have been the result of the fact that EC auditors did not fully acknowledge the differences between Canadian and EC legislative structures.

The audit report does not link the findings to the potential for adverse effects on human health. It does not recognize that differing legislative systems can achieve the same health and safety objectives.

Canada would hope that, toward a fuller understanding of the Canadian residue control system, the EC will agree to reconsider its conclusions in light of the discussions and clarifications that have preceded Canada's final response and the publication of the audit team's final report.