Miel Labonté Inc. v. Canada (Attorney General)
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Miel Labonté Inc. v. Canada (Attorney General) Court (s) Database Federal Court Decisions Date 2006-02-14 Neutral citation 2006 FC 195 File numbers T-1847-04 Notes Digest Decision Content Date: 20060214 Docket: T-1847-04 Citation: 2006 FC 195 Ottawa, Ontario, the 14th day of February 2006 PRESENT: THE HONOURABLE MR. JUSTICE SIMON NOËL BETWEEN: MIEL LABONTÉ INC. Applicant and THE ATTORNEY GENERAL OF CANADA and THE CANADIAN FOOD INSPECTION AGENCY Respondents REASONS FOR ORDER AND ORDER [1] This is an application for judicial review of a decision by the Minister of Agriculture and Agri-Food Canada (the Minister) on April 3, 2004, ordering the recall of a lot of honey (production code 033196) marketed by Miel Labonté Inc. (the applicant). According to the applicant, the Minister did not have the right, based on the information at his disposal, to make the disputed order pursuant to subsection 19(1) of the Canadian Food Inspection Agency Act (CFIAA). The applicant further alleged that the Minister and the Canadian Food Inspection Agency (CFIA) failed to observe their duty of fairness. [2] The applicant is asking this Court to: - quash the Minister’s order; - rule that the CFIA and the Minister had no reasonable grounds for believing that the natural liquid honey from blueberry blossoms bearing production code 033196 (the applicant’s honey) posed a risk to public health; - rule that the CFIA and the Minister violated their duty of fairness by not allowing the applicant to be inform…
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Miel Labonté Inc. v. Canada (Attorney General) Court (s) Database Federal Court Decisions Date 2006-02-14 Neutral citation 2006 FC 195 File numbers T-1847-04 Notes Digest Decision Content Date: 20060214 Docket: T-1847-04 Citation: 2006 FC 195 Ottawa, Ontario, the 14th day of February 2006 PRESENT: THE HONOURABLE MR. JUSTICE SIMON NOËL BETWEEN: MIEL LABONTÉ INC. Applicant and THE ATTORNEY GENERAL OF CANADA and THE CANADIAN FOOD INSPECTION AGENCY Respondents REASONS FOR ORDER AND ORDER [1] This is an application for judicial review of a decision by the Minister of Agriculture and Agri-Food Canada (the Minister) on April 3, 2004, ordering the recall of a lot of honey (production code 033196) marketed by Miel Labonté Inc. (the applicant). According to the applicant, the Minister did not have the right, based on the information at his disposal, to make the disputed order pursuant to subsection 19(1) of the Canadian Food Inspection Agency Act (CFIAA). The applicant further alleged that the Minister and the Canadian Food Inspection Agency (CFIA) failed to observe their duty of fairness. [2] The applicant is asking this Court to: - quash the Minister’s order; - rule that the CFIA and the Minister had no reasonable grounds for believing that the natural liquid honey from blueberry blossoms bearing production code 033196 (the applicant’s honey) posed a risk to public health; - rule that the CFIA and the Minister violated their duty of fairness by not allowing the applicant to be informed in advance of the reasons relied on by the CFIA, the scientific data at its disposal and the method of analysis which it was applying, and to lead expert evidence in rebuttal. CONCLUSION [3] The application for judicial review is dismissed. FACTS [4] Before ruling on the points at issue, it is important to describe the facts which gave rise to this application. [5] The applicant has been operating a honey business for over 30 years. In the course of its business, it has been importing honey from Argentina since 2002. On May 12, 2003, it ordered 38,464 kg of honey from that country through the Odem company, worth $137,048.77. The honey was to be used to produce blueberry blossom honey, by being mixed with Canadian honey. An analysis was conducted by a laboratory with which the applicant dealt, J.R. Laboratories Inc. (the J.R. Laboratories analysis) before the transaction was concluded. [6] In fall 2003 doubts began to surface in business circles about the possible presence of nitrofuran in honey from some countries, including Argentina. The CFIA published several notices during the course of March 2004 about the possible presence of nitrofuran in the honey. First, there was a notice to the industry dated March 2004 (there is no exact date – [translation] “March 2004 Notice to Industry” – at page 45 of respondents’ record). That notice read as follows: [translation] Please be advised that the Canadian Food Inspection Agency (CFIA) has initiated a residue monitoring program for nitrofurans in honey. Nitrofurans are banned in Canada and many other countries. Foods contaminated with nitrofuran drugs are not considered safe for human consumption. The CFIA will sample both domestic and imported honey shipments, during March of 2004, for contamination by nitrofuran residues. Testing methods will be sensitive to a contamination level at least as low as 0.5 ppb. In the event that test results reveal higher than detectable limits, the CFIA will undertake appropriate follow-up inspection an d compliance measures, including a possible recall of contaminated product. [7] Another notice was sent out on March 13, 2004 regarding honey bearing another brand ([translation] “March 13, 2004 Notice” – at page 21 of respondents’ record). [8] Finally, a notice was released on the Internet on March 23, 2004, part of which follows ([translation] “March 23, 2004 Notice” – at page 26 of respondents’ record): [translation] UPDATE - HEALTH HAZARD ALERT VARIOUS IMPORTED HONEY PRODUCTS MAY CONTAIN NITROFURANS OTTAWA, March 23, 2004 - The Canadian Food Inspection Agency (CFIA) is warning the public not to consume various imported honey because these products may contain nitrofurans. . . . Nitrofurans are antimicrobial drugs which are banned for use in Canada in food producing animals. Consumption of foods contaminated with nitrofurans may pose a human health risk related to the inherent toxicity of the drug and the potential to cause allergies. There have been no reported illnesses associated with the consumption of this product. . . . [9] On March 26, 2004, the CFIA’s Veterinary Drugs Directorate concluded in a report prepared at the CFIA’s request (“Health Risk Assessment of March 26, 2004”) that the honey contaminated by nitrofuran residues posed a risk to human health on account of its carcinogenic effects and that the sale of this honey should be prohibited. The same report recommended the recall and destruction of the contaminated products. [10] An analysis of a sample of the Applicant’s Product was conducted by a CFIA laboratory on April 2, 2004 ([translation] “Analysis of Applicant’s Product on April 2, 2004”). That analysis confirmed the presence of nitrofuran in the applicant’s honey. At 8:20 pm on April 2, the CFIA informed Jean-Marc Labonté (Mr. Labonté), the applicant’s president. The parties’ versions of the facts thereafter differ slightly. [11] According to Mr. Labonté’s affidavit, on the evening of April 2, 2004 (a Friday), the CFIA required the applicant to call back its employees immediately and warn all businesses to take the product off the shelves, failing which the Minister would make a recall order. The applicant protested and asked for time to discuss the matter and produce control tests. On April 4, 2004, a CFIA inspector went to Mr. Labonté’s residence to serve a signed recall notice on him and the applicant was given 24 hours to proceed to a recall. [12] The respondents’ version is as follows. It appeared from the CFIA’s Incident Report ([translation] “Incident Report”) that Mr. Labonté was called at 8:20 pm on April 2 and told about a possible recall and the reasons for the contemplated decision. A copy of the analysis of the applicant’s product on April 2, 2004 was sent to Andrew Bond, the applicant’s employee, at 9:27 pm on April 2, 2004. At 8:45 pm, Mr. Labonté was asked to prepare a recall notice and forward it to the CFIA for review and issuance to distributors. In the respondents’ submission, the applicant’s president refused to cooperate. As the Office of Food Safety and Recall (OFSR) had concluded that a Class I recall should be ordered, Mr. Labonté was so notified at 8:50 pm. At that time, he refused to comply with the CFIA’s request and stated that future communications should be made through his lawyer. A telephone call between counsel followed, during which the CFIA again inquired about measures the applicant wanted to take to recall the products. Counsel for the applicant confirmed his client’s position, challenging the CFIA’s conclusions and repeating its intention not to voluntarily recall the honey. [13] On April 3, 2004, the president of the CFIA sent the Minister a request in writing ([translation] “Request to Minister of April 3, 2004”) asking him to recall the liquid natural blueblerry blossom honey marketed by the applicant under production code 033196 and contained in 500 g pots. This request, entitled “Request for Mandatory Recall of Labonté Brand Honey”, explained the nature of the risk, the nature of the product and the circumstances having led the CFIA to request a recall. On the same day, as mentioned earlier, the Minister ordered a recall pursuant to this request in a signed recall notice (“Recall Notice of April 3, 2004”). On the morning of April 4, Mr. Labonté was given a copy of his notice. [14] After the Recall Notice of April 3, 2004 was published, several follow-up measures were taken to ensure that the recall was done correctly (at pages 94 et seq. of the respondents’ record). The Incident Report indicates that the CFIA contacted several distributors during April and inquired as to the steps taken to contact distributors and retailers. A request to check the effectiveness of the recall was made to the Ministère de l’Agriculture, des Pêcheries et de l’Alimentation du Québec (MAPAQ). ISSUES [15] Essentially, the applicant made three arguments. For a clear understanding of these issues, each of these arguments must be dealt with separately. [16] The first argument related to subsection 19(1) of the CFIAA: the Minister had to believe on reasonable grounds that the applicant’s honey posed a risk to public health. The applicant argued this was a question of jurisdiction, relying on paragraph 21 of the affidavit of Jean-Louis Michaud, a CFIA food safety and recall coordinator, which read as follows: [translation] Such a compulsory recall order is one of the exceptional measures to be considered when a business refuses to cooperate with the CFIA, as by refusing and/or neglecting to voluntarily recall from the market a product which, in the opinion of the Minister of Agriculture and Agri-Food and the experts at the CFIA and Health Canada, poses a risk to public health. In my opinion, this question should not be viewed as one of jurisdiction. The CFIAA stated that a recall may be ordered if there are reasonable grounds to believe that a product poses a risk to public health. The above-cited paragraph from Mr. Michaud’s affidavit simply adds that it is the CFIA’s practice to initially seek the cooperation of a person selling, marketing or distributing a product before ordering a recall. That does not amount to an admission that the Minister ignored the test laid down in subsection 19(1) of the CFIAA and replaced it by another test, namely a refusal to cooperate. In other words, the fact that the CFIA tried to cooperate with the applicant does not mean that the Minister did not also have reasonable grounds to believe that the honey posed a risk to public health. For these reasons, the question is not one of jurisdiction and thus is not subject to the standard of correctness. Instead, a pragmatic and functional analysis and the decisions filed by the respondents at the hearing suggest that great restraint is called for, as explained below. [17] The applicant advanced a second argument. It maintained that the Minister did not choose the appropriate action to be taken in the circumstances. It emphasized the very low concentration of nitrofuran which it said existed in its honey and added that, according to some evidence in the record, the product only posed a health risk if it was consumed in very large quantities or over a very long period. In other words, the applicant said the situation was not urgent and, in the circumstances, the Minister acted with undue haste. [18] Finally, the last argument advanced related to procedural fairness: the issue here is whether the Minister had a duty to act fairly toward the applicant and whether that duty was complied with. [19] In view of the foregoing, this application raises the three following issues: - Did the Minister have reasonable grounds to believe, as required by subsection 19(1) of the CFIAA, that the applicant’s honey posed a risk to public health? - Did the Minister err in ordering a recall of the applicant’s honey? - Did the Minister violate his duty of fairness toward the applicant? APPLICABLE LEGISLATION [20] Subsection 19(1) of the CFIAA reads as follows: 19. (1) Where the Minister believes on reasonable grounds that a product regulated under an Act or provision that the Agency enforces or administers by virtue of section 11 poses a risk to public, animal or plant health, the Minister may, by notice served on any person selling, marketing or distributing the product, order that the product be recalled or sent to a place designated by the Minister. 19. (1) S’il a des motifs raisonnables de croire qu’un produit régi par une loi ou disposition dont l’Agence est chargée d’assurer ou de contrôler l’application aux termes de l’article 11 présente un risque pour la santé publique ou celle des animaux ou des végétaux, le ministre peut, par avis signifié à la personne qui vend, met en marché ou distribue ce produit, en ordonner le rappel ou son envoi à l’endroit qu’il désigne. OBJECTIONS TO EVIDENCE [21] The respondents objected to the filing by the applicant of several documents, the date of which was subsequent to the recall order. At the hearing, the applicant asked that these documents be struck from the record, and this was agreed to by the Court. ANALYSIS 1. Standard of review [22] Two distinct standards of review apply in the case at bar. The first standard applies to the Minister’s decisions under subsection 19(1) of the CFIAA. The second standard of review applies to the choice of the applicable procedural guarantees. [23] As the issue of the scope of the procedural guarantees is simply one of law, no restraint is required. Accordingly, the standard of correctness applies. There is no need to discuss this point in further detail. [24] As far as I know, the issue of the standard of review applicable to decisions by the Minister under section 19(1) of the CFIAA has not been examined by the courts. To begin with, therefore, for purposes of comparison, we must see whether some ministerial or administrative decisions which have been the subject of judicial review may be similar to the decision at issue herein. Secondly, we must conduct a pragmatic and functional analysis, according to the leading cases of Pushpanathan v. Canada, [1998] 1 S.C.R. 982, and Dr. Q v. College of Physicians and Surgeons of British Columbia, [2003] 1 S.C.R. 226. (a) Case law [25] Two cases submitted by counsel for the respondents at the hearing are relevant as examples. These are BC Landscape & Nursery Assn. v. Canada (Attorney General), [2000] F.C.J. No. 1148, and Friends of Point Pleasant Park v. Canada (Attorney General), [2000] F.C.J. No. 2012. [26] First, BC Landscape & Nursery Assn. involved the judicial review of decisions of the Minister of Agriculture and Agri-Food to refuse to exercise the discretion conferred on him by section 3 of the Plant Protection Regulations, SOR/95-212 (PPR). This power is similar to the power exercised in the case at bar and there is some similarity between subsection 19(1) of the CFIAA and section 3 of the PPR. That section reads as follows: 3. Where, after a pest risk assessment, the Minister or an inspector believes on reasonable grounds that a thing is a pest, or a thing or place is or could be infested or constitutes or could constitute a biological obstacle to the control of a pest, and the Minister determines that, in the circumstances, it is necessary and cost-justifiable to take pest control measures, an inspector shall, as appropriate in the circumstances for the purpose of eradicating the pest or preventing its spread, take one or more of the actions that the inspector is authorized to take under the Act or any regulation or order made thereunder. 3. Lorsque le ministre ou l’inspecteur, à la suite d’une analyse du risque phytosanitaire, a des motifs raisonnables de croire qu’une chose soit est un parasite, soit est parasitée ou susceptible de l’être, qu’un lieu est infesté ou susceptible de l’être ou que la chose ou le lieu constitue ou peut constituer un obstacle biologique à la lutte antiparasitaire et lorsque le ministre établit que, compte tenu des circonstances, des mesures de la lutte antiparasitaire sont nécessaires et justifiables quant aux coûts, l’inspecteur prend une ou plusieurs des mesures que la Loi ou ses textes d’application l’autorisent à prendre et qui sont indiquées dans les circonstances pour l’élimination des parasites ou pour la prévention de leur propagation. [27] In BC Landscape & Nursery Assn., Gibson J. made a distinction between the preliminary question of whether the decision-maker should act and the question of what action should be taken. At paragraph 21, he wrote: I am satisfied that section 3 of the Plant Protection Regulations provides for two separate but interrelated decisions. The first is a threshold test. It involves first, a “pest risk assessment”. Where a pest risk assessment is carried out, the Minister or an inspector is then required to determine whether he or she believes, on reasonable grounds, that a thing, presumably the subject of the pest risk assessment, is a pest, or a thing or place is or could be infested or a thing or place constitutes or could constitute a biological obstacle to the control of a pest. Once the first two stages of the threshold test are completed, and presumably assuming positive determinations in respect of each of those stages, as a third stage, the Minister must make a determination as to whether or not, in the circumstances, “. . . it is necessary and cost-justifiable to take pest control measures”. [28] It is worth noting that the arguments advanced by the applicant corresponded to the distinction made by Gibson J.. The applicant argued, firstly, that the Minister had no reasonable grounds to take any action whatever, and secondly, that even if he had such grounds, the action taken, namely a swift recall of the honey, was excessive. However, that has no bearing on the standard of review, which is the same in both cases. Gibson J. undertook a general pragmatic and functional analysis and ruled that the applicable standard of review was that of the patently unreasonable decision. At paragraph 31, he wrote: I am satisfied that the words of section 3 of the Plant Protection Regulations invest considerable discretion in the Minister at the level of the threshold test. It is his or her responsibility to make a determination whether or not, in the circumstances, it is necessary and cost-justifiable to take pest control measures. It is his or her determination of what are the relevant circumstances that impact on, when it is necessary and when it is cost-justifiable. Those words leave considerable discretion to the Minister. Only after that discretionary determination does it fall to an inspector to make a choice “as appropriate in the circumstances”, presumably in his or her opinion and, as here, after consultation with the Minister, of the appropriate actions. There is no privative clause in law relating either to the threshold decision or the choice among actions available to an inspector. Both the Minister and the inspector must be considered to have special expertise in the area of their responsibilities. The purpose of section 3 of the Regulations is clearly to facilitate the Minister and his or her officials in carrying out their responsibilities under the International Plant Protection Convention, as well as under the Constitution of Canada. As such, considerable flexibility for the Minister and inspectors is warranted and significant deference is appropriate subject to limited judicial control and more significant political accountability. The nature of the problem in question is not limited in geographical terms either to a single province or to Canada as a whole. It has significant international implications. Once again, I conclude that this augurs in favour of significant deference. It is against these factors outlined in paragraphs 57 to 61 of the Baker decision, and the facts of this matter, that I conclude that the appropriate standard of review is patent unreasonableness. [29] The second case relevant to the case at bar is Friends of Point Pleasant Park. That case involved the exercise of a power of the same type, namely the power of the Minister of Agriculture and Agri-Food or a CFIA inspector to issue a Notice to Dispose for trees suspected of being infested by a parasite. The power is set out in subsection 27(1) of the PPR, which reads as follows: 27. (1) Where the Minister or an inspector believes on reasonable grounds that a thing is a pest, is or could be infested or constitutes or could constitute a biological obstacle to the control of a pest, any inspector may require the owner or person having the possession, care or control of the thing to dispose of it. 27. (1) Lorsque le ministre ou l’inspecteur a des motifs raisonnables de croire qu’une chose soit est un parasite, soit est parasitée ou susceptible de l’être, soit encore constitue ou peut constituer un obstacle biologique à la lutte antiparasitaire, l’inspecteur peut exiger de son propriétaire ou de la personne qui en a la possession, la responsabilité ou la charge des soins qu’il en dispose, notamment par destruction. [30] At paragraph 50, Mackay J. also ruled that the applicable standard was that of patent unreasonableness: The inspector's decision concerning the action to be taken, in this case to issue and enforce a Notice to Dispose, is a matter of discretion involving judgment in light of the evidence available that a pest exists, or a thing is or is suspected to be infested and the risk it may present. That decision is one to which the Court will give deference unless it be patently unreasonable, in the sense that there is no evidence to support the decision taken. That is the standard for assessment which Mr. Justice Gibson reached in B.C. Landscaping and Nursery Association for the decision in question in that case concerning the action to be taken. [31] In short, the salient point in BC Landscape & Nursery Assn. and Friends of Point Pleasant Park is the following. The decision by which the Minister or the CFIA concludes that action should be taken in the public interest, and the decision by which they choose which action is necessary, are discretionary decisions calling for a high degree of judicial restraint (the patent unreasonableness standard). This is confirmed by the pragmatic and functional analysis, and several of the comments made by Gibson J. in BC Landscape & Nursery Assn. may be followed in relation to subsection 19(1) of the CFIAA. (b) Pragmatic and functional analysis [32] We should recall the factors that must be taken into account in determining the applicable standard of review. In Dr. Q v. College of Physicians and Surgeons of British Columbia, [2003] 1 S.C.R. 226, at paragraph 26, McLachlin C.J. wrote: In the pragmatic and functional approach, the standard of review is determined by considering four contextual factors — the presence or absence of a privative clause or statutory right of appeal; the expertise of the tribunal relative to that of the reviewing court on the issue in question; the purposes of the legislation and the provision in particular; and the nature of the question — law, fact, or mixed law and fact. The factors may overlap. The overall aim is to discern legislative intent, keeping in mind the constitutional role of the courts in maintaining the rule of law . . . The virtue of the pragmatic and functional approach lies in its capacity to draw out the information that may be relevant to the issue of curial deference. [33] The first factor concerns the review mechanism set out in the Act. There is no privative clause here. In Pushpanathan v. Canada [1998] 1 S.C.R. 982, at paragraph 30, however, Bastarache J. wrote that: “the absence of a privative clause does not imply a high standard of scrutiny, where other factors bespeak a low standard”. [34] The second factor is the decision-maker’s expertise. The CFIA is responsible for the administration of several statutes dealing with agriculture, safety, breeding, public health and food quality. However, it is not the Agency that assesses whether there are reasonable grounds to believe that a product poses risks to public health, but the Minister himself or herself. [35] The third factor, Parliament’s intention (the purpose of the legislation), seems to the Court to be conclusive. The wording of subsection 19(1) of the CFIAA is wide and grants the Minister a broad discretion. It is clear from reading this section and the Act as a whole that the purpose of Parliament was to give priority to public health by allowing products to be recalled as soon as there are “reasonable grounds” to believe that they pose a risk to public health. The degree of certainty required is not high: Parliament did not require the existence of overwhelming evidence. The power in question is discretionary and calls for restraint. Further, I note the use of the words “reasonable grounds to believe”, “risk” and “may”, which all suggest a high degree of discretion. I further note the wording of the preamble to the CFIAA, which emphasizes the public health and consumer protection purposes: Attendu : . . . […] WHEREAS the consolidation of those services under a single food inspection agency will contribute to consumer protection and facilitate a more uniform and consistent approach to safety and quality standards and risk-based inspection systems . . . que le regroupement de ces services sous les auspices d’une agence unique contribuera à la protection des consommateurs et facilitera l’application uniforme et coordonnée des normes de salubrité, de sécurité et de qualité et des méthodes d’inspection fondées sur les risques . . . [36] Finally, the nature of the question must be taken into account. In my opinion, the question is largely factual as no point of law has to be decided pursuant to subsection 19(1) of the CFIAA, save the application of the “reasonable grounds” standard. [37] Accordingly, my pragmatic and functional analysis leads me to rule that the standard of review applicable to a decision by the Minister under subsection 19(1) of the CFIAA is that of patent unreasonableness. 2. Did the Minister have reasonable grounds to believe, as required by subsection 19(1) of the CFIAA, that the applicant’s honey posed a risk to public health? [38] According to the applicant, [translation] “there was no serious indication of a health risk” and the Minister could not [translation] “objectively and reasonably believe” that the applicant’s honey posed a health risk. In particular, it stressed the following passage from the Health Risk Assessment of March 26, 2004, at page 7: The residues present in the imported honey are very low and hence the increased risk associated with consumption of this honey is also expected to be low. However, the risk to human health increases if the contaminated product is consumed for a prolonged period of time. [39] The applicant further submitted that the Health Risk Assessment of March 26, 2004 indicated that, in order to be at risk, a person would have to consume 170 g of this honey daily. It stressed that the Health Risk Assessment of March 26, 2004 did not indicate that any study had been done on the applicant’s honey. [40] Further, the applicant sought to challenge the reliability of the method used by the CFIA. In its opinion, no reliable and exact method existed in 2003, and still to this day none exists for detecting nitrofuran residues in food products. According to Mr. Labonté’s affidavit, 17 international laboratories are working on the development of such a method and the CFIA has refused to participate in this effort. The applicant further noted that a method which could detect concentrations on the order of 0.5 ppb to 1.0 ppb would have to be considered suspect and the CFIA’s method of analysis has not been published. The applicant concluded by arguing that the information given to the Minister was incomplete, not scientifically reliable and not checked by the CFIA and that the best scientific sources consider that the presence of nitrofuran in honey at a 1 ppb level does not constitute a health risk justifying a recall order. In the applicant’s submission, a very large quantity of nitrofuran would have to be consumed to pose any risk, or it would have to be consumed regularly over a very long period of time. [41] The respondents submitted that the Minister had reasonable grounds to believe that the applicant’s honey posed a public health risk. In this respect, they relied essentially on the Health Risk Assessment of March 26, 2004, which they said concluded that the presence of nitrofuran in honey products posed a public health risk. The respondents stressed the passage of the report at page 7 cited earlier (see paragraph 38 hereof) and the following passage, at page 1: All nitrofurans are banned for use in food producing animals in Canada . . . since they have been found to be mutagenic and carcinogenic in laboratory test animals. Thus, any residues of these drugs that can be detected and confirmed by the best available analytical methodology is considered a violation of the Food and Drugs Act and Regulations. [42] The respondents also relied on several public health risk notices broadcast on the Internet, on the March 2004 Notice to Industry and on the Analysis of the Applicant’s Product on April 2, 2004, which confirmed the presence of nitrofuran in the sample of the honey marketed by the applicant. [43] The respondents also opined that the detection method used was reliable. Paragraphs 37 and 38 of Jean-Louis Michaud’s affidavit sum up the respondents’ approach in this regard: [translation] 37. This method is based on a method developed in the Netherlands where a CFIA chemist went to and received training. The method is used in the European Union. Like Health Canada, as mentioned in paragraph 33 hereof, CFIA scientists consider that if the method permits detection of 5-nitrofuran the result should be reported. 38. Method ACC-070 is contained in the compilation “Additives and Chemical Contaminants Analytical Methods Manual”. It is public, available on request and has been widely distributed in the industry. It has also been the subject of scientific presentations, in particular by the distribution of documents and audio-visual presentations to affected clientele, including Miel Labonté Inc. Evidence of the publication of this method of analysis and the holding of information seminars is found in the record (see at pages 63 et seq. of the applicant’s record). The Powerpoint presentation on the subject at Dorval on March 19, 2004 appears at pages 72 et seq. and the exchange of e-mails on this matter at pages 80 et seq.. [44] After reviewing all the evidence available to the Minister at the time he made his decision, I am of the view that, based on that evidence, he had reasonable grounds to believe that the liquid natural blueberry blossom honey bearing production code 033196 posed a public health risk. In my opinion, as Mackay J. stated in Friends of Point Pleasant Park, supra, at paragraph 49, “reasonable grounds” means that “some evidence . . . must exist to support the decision”. In the case at bar, the Minister had ample evidence that could convince him there was a public health risk. [45] To begin with, as indicated above, several notices were sent out during March. Those notices, which were before the Minister at the time he made his decision, demonstrate the genuine concern of the CFIA about the possible presence of nitrofuran in the honey and show that it took steps to inform the industry and the public about this. There was the March 2004 Notice to Industry (at page 45 of respondents’ record), the Notice of March 13, 2004 and, finally, the Notice of March 23, 2004. Taken as a whole, such notices could be taken into account by the Minister in deciding whether reasonable grounds existed to believe that the applicant’s honey posed a public health risk. [46] In addition, the central element on which the Minister’s decision was based was the Request to the Minister of April 3, 2004, as well as the evidence in the record which, taken as a whole, could give the Minister reasonable grounds to believe that the applicant’s honey posed a public health risk. In particular, that very letter states the following at paragraph 3: Nitrofurans are a class of antimicrobial drugs banned for use in Canada in food producing animals. Health Canada considers that the honey product poses serious risk to consumers and assigned the product a Class I Health Risk. In particular, Health Canada has advised the CFIA of its concerns with nitrofurans in food products due to their potential carcinogenicity and genotoxicity. [47] The Minister also had available the Health Risk Assessment of March 26, 2004, the salient points of which I set out below (at pages 1, 5, 7 and 8): (p. 1) All nitrofurans are banned for use in food producing animals in Canada . . . since they have been found to be mutagenic and carcinogenic in laboratory test animals. Thus, any residues of these drugs that can be detected and confirmed by the best available analytical methodology is considered a violation of the Food and Drugs Act and Regulations. . . . (p. 5) Risk Assessment Potential health hazard in this case involves the exposure of humans to residues of nitrofuran drugs that are not considered safe for human consumption. While there are health benefits to the treated animals associated with the use of antimicrobials under certain conditions, drug residues may pose health risks related to the inherent toxicity of the drug and the potential to cause allergies. Nitrofurantoin (macrodantin, furadantin, others) is currently being used in human medicine (both adults and children) in Canada, the USA, and other countries for the treatment of urinary tract infections caused by bacteria. The most common adverse effects with this drug in humans are digestive system-related, such as nausea, vomiting, and diarrhea. Various hypersensitive reactions occasionally occur. Potential health risk concerns in humans are related to the carcinogenic and mutagenic potential of the drug. . . . (p. 7) Hazard Characterization Nitrofuran residues in food derived from contaminated honey may pose health risks related to the inherent toxicity of the drug and the potential to cause allergies. Nitrofurans are a group of chemicals classified as cancer-causing and consequently have been banned for use in food-producing animals in most countries of the world including Canada. This complete ban is in line with the opinion of the Codex Alimentarius, the United Nations body which sets international food safety standards. Nitrofurazone and furazolidone were discussed at the 40th Joint FAO/WHO Expert Committee on Food Additives (JECFA) and extensive data were available for assessment for both compounds. In essence, JECFA concluded that nitrofurazone was carcinogenic whereas furazolidone was genotoxic as well as carcinogenic. In addition, nitrofurazone was observed to cause severe arthropathy in experimental animals. Nitrofurans are banned for use in food-producing animals in Canada. This is because of health concerns including a possible increased risk of cancer in humans through long-term dietary exposure. The residues present in the imported honey are very low and hence the increased risk associated with consumption of this honey is also expected to be low. However, the risk to human health increases if the contaminated product is consumed for a prolonged period of time. In view of the fact that Canada has banned the use of nitrofurans in food producing animals, any residue of nitrofurans present in food are a violation under Section 4 of the Food and Drugs Act based on Section B.01.048 and C.01.610.1 of the Food and Drug Regulations. (p. 8) In recognition of the risk to human health (although small) from exposure to carcinogenic compounds through consumption of nitrofuran residue contaminated honey from Australia, or any other country, sale of contaminated honey in Canada should be precluded. [Emphasis added.] [48] The Minister’s record also contains the Analysis of the Applicant’s Product on April 2, 2004. That Analysis contains, inter alia, the following: [translation] CANADIAN FOOD INSPECTION AGENCY ANALYSIS REPORT FOOD PRODUCT SAMPLING SUMBISSION FORM . . . Product: Honey Lot: 033196 Unit of measure: 500g. Common name: Honey from blueberry blossoms Brand: Labonté Method: ACC-070 Nitrofuran Screen – Positive Test assessed: Unsatisfactory Method: ACC-070 3 Amino-2-oxazolidinone (AOZ) 0.5 ppb Analysis result: Unsatisfactory Job authorized: 2004/04/02 Authorized by: Fred Butterworth Job assessed: Unsatisfactory Comment: AOZ present [49] The Food and Drugs Act, R.S.C. 1985, c. F-27, the Food and Drugs Regulations, C.R.C., c. 870, and the Honey Regulations, C.R.C., c. 287, also have to be considered. The relevant provisions of those documents read as follows: Food and Drugs Act Loi sur les aliments et drogues . . . […] 2. In this Act, 2. Les définitions qui suivent s’appliquent à la présente loi : "food" includes any article manufactured, sold or represented for use as food or drink for human beings, chewing gum, and any ingredient that may be mixed with food for any purpose whatever; « aliment » Notamment tout article fabriqué, vendu ou présenté comme pouvant servir de nourriture ou de boisson à l’être humain, la gomme à mâcher ainsi que tout ingrédient pouvant être mélangé avec un aliment à quelque fin que ce soit. . . . […] 4. No person shall sell an article of food that 4. Il est interdit de vendre un aliment qui, selon le cas : (a) has in or on it any poisonous or harmful substance; a) contient une substance toxique ou délétère, ou en est recouvert; (b) is unfit for human consumption; b) est impropre à la consommation humaine; (c) consists in whole or in part of any filthy, putrid, disgusting, rotten, decomposed or diseased animal or vegetable substance; c) est composé, en tout ou en partie, d’une substance malpropre, putride, dégoûtante, pourrie, décomposée ou provenant d’animaux malades ou de végétaux malsains; (d) is adulterated; or d) est falsifié; (e) was manufactured, prepared, preserved, packaged or stored under unsanitary conditions. e) a été fabriqué, préparé, conservé, emballé ou emmagasiné dans des conditions non hygiéniques. . . . […] Food and Drugs Regulations Règlement sur les aliments et drogues . . . […] B. 01. 048. (1) No person shall sell B. 01. 048. (1) Il est interdit de vendre : (a) any animal intended for consumption as food if any product containing any drug listed in subsection (2) has been administered to the animal; a) des animaux qui sont destinés à être consommés comme aliments et auxquels a été administré un produit contenant une drogue mentionnée au paragraphe (2); (b) any meat, meat by-products, eggs or milk intended for consumption as food and derived from an animal if any product containing any drug listed in subsection (2) has been administered to that animal; or b) de la viande, des sous-produits de viande, des oeufs ou du lait qui sont destinés à être consommés comme aliments et qui proviennent d’un animal auquel a été administré un produit contenant une drogue mentionnée au paragraphe (2); (c) any meat, meat by-products, eggs or milk that contains any residue of any drug listed in subsection (2). c) de la viande, des sous-produits de viande, des oeufs ou du lait contenant des résidus d’une drogue mentionnée au paragraphe (2). (2) The drugs referred to in subsection (1) are (2) Les drogues visées au paragraphe (1) sont : . . . […] (b) a 5-nitrofuran compound; b) un composé de 5-nitrofurane; . . . […] C. 01. 610. 1 No person shall sell a drug for administration to animals that produce food or that are intended for consumption as food if that drug contains C. 01. 610. 1 Il est interdit de vendre une drogue pour administration aux animaux qui produisent des aliments ou qui sont destinés à être consommés comme aliments si elle contient : . . . […] (b) a 5-nitrofuran compound; b) soit un composé de 5-nitrofurane; . . . […] Honey Regulations Règlement sur le miel 2. (1) In these Regulations, 2. (1) Dans le présent règlement, "contaminated", in respect of honey, means containing a chemical, drug, food additive, heavy metal, industrial pollutant, ingredient, medicament, microbe, pesticide, poison, toxin or any other substance not permitted by, or in an amount in exces
Source: decisions.fct-cf.gc.ca
Klouvi c. Canada (Procureur général)
2024 CAF 80