Proposal - Contaminant Standards for Aflatoxins, Deoxynivalenol, Fumonisins, Ergot Alkaloids and Salmonella in Livestock Feeds

August 2017

Purpose

The Canadian Food Inspection Agency (CFIA) has embarked on a comprehensive change agenda to strengthen its foundation of legislation, regulatory programs and inspection approaches and tools. These directions set a context for the renewal of the federal Feeds Regulations (Regulations).

The goal of renewing the Regulations is to develop a modernized risk- and outcome-based regulatory framework for feeds which:

  • safeguards feeds and the food production continuum;
  • attains the most effective and efficient balance between fair and competitive trade in the market; and
  • minimizes regulatory burden.

Modernization of the Regulations provides the opportunity to review feed controls, standards, labelling and other regulatory requirements. The purpose of this proposal is to review the standards for some biological contaminants that are known or reasonably foreseeable to be present in feeds:

  • mycotoxins
    • aflatoxins,
    • deoxynivalenol,
    • fumonisins,
    • ergot alkaloids, and
  • Salmonella

At present, maximum standards referenced in this proposal are found (other than for Salmonella) in the current Feeds Regulations or in regulatory guidance (RG-8).

Given the considerations outlined below, the CFIA is aiming to provide a science-based, enforceable list of maximum levels for some known microbial and chemical contaminants in feeds. This list can be updated in a timely manner, as needed, to reflect changing risks and science.

Background and Current Situation

The CFIA verifies that livestock feeds manufactured and sold in Canada, or imported, are safe, effective, and labelled appropriately to contribute to the production and maintenance of healthy livestock and safe foods of animal origin. The CFIA confirms compliance with standards by a variety of activities including pre-market assessments and inspection of products in the market (e.g., product sampling and testing) that includes monitoring for the presence of known contaminants.

At present, Section 19(1) of the Regulations requires:

19(1) Subject to subsections (2) and (3), a feed shall not contain…

i) aflatoxins in an amount exceeding 20 parts per billion;
(j) any material in quantities that could, when fed in proportions commonly used or as specified in the feeding directions, result in the production of an article of food that is prohibited from sale by virtue of section 4 of the Food and Drugs Act; or
(k) any material, other than those referred to in paragraphs (a) to (j), in quantities likely to be deleterious to livestock, when fed in proportions commonly used or as specified in the feeding directions.

In addition, there are two (2) reportable diseases under the Health of Animals Act that are caused by Salmonella spp. serotypes S. Pullorum and S. Gallinarum. All cases must be reported to the CFIA.

To provide greater clarity to regulated parties and other stakeholders regarding standards for those contaminants not specifically identified in the Regulations, the CFIA provides guidance in the form of action levels for additional contaminants, e.g. mycotoxins, in the publication RG-8 Regulatory Guidance: Contaminants in Feed

Considerations

Livestock feed and feed ingredients can act as a route of entry for biological hazards into human food chain and can pose a risk to animal health, and the environment. The prevention, identification and risk management of such hazards is not the sole responsibility of any one sector in the feed supply chain (feed ingredient suppliers → commercial feed manufacturers → feed distributors/retailers → on-farm feed manufacturers and livestock feeders). Integrated approaches to the control of biological hazards need to be considered to manage them effectively.

Some examples are:

Mycotoxins

Mycotoxins are secondary metabolites produced by a variety of moulds that grow on several agricultural commodities under specific environmental conditions. It has been estimated that at least 25% of the grain produced each year worldwide is contaminated with mycotoxins. Mould contamination of cereal crops is an area of concern to the Canadian livestock industry. The presence of moulds and mycotoxins pose a significant threat to animal health and productivity. Mycotoxins present in feed could also be a food safety concern as some mycotoxins can be transferred to humans through foods of animal origin. In Canada, the mycotoxins of concern are the trichothecenes (including deoxynivalenol, nivalenol, T-2 toxin and HT-2 toxin), zearalenone, fumonisins, ochratoxins (predominantly ochratoxin A), and ergot alkaloids. Aflatoxins are of concern in food and feed ingredients imported from warmer tropical and subtropical regions.

Owing to their impact on health and safety, the CFIA, under the National Feed Inspection Program, has been monitoring for several mycotoxins in domestic and imported feeds for over 25 years. The maximum level for aflatoxins is currently set in Section 19 of the Feeds Regulations. Action levels for additional mycotoxins such as deoxynivalenol and fumonisins have been established and published in regulatory guidance, RG-8 Regulatory Guidance: Contaminants in Feed. These standards are used to determine risk management options for non-compliant feeds and feed ingredients.

A short description of aflatoxins, deoxynivalenol, fumonisins and ergot alkaloids as well as the impact on health and safety is presented in Appendix I.

Salmonella

Salmonella is one of the most common foodborne zoonotic pathogens causing health and economic impact in humans and animals. Salmonella infections in humans are mainly acquired from contaminated fresh produce, dairy products, raw or undercooked meats, and eggs. International evidence has demonstrated that a farm-to-fork approach is critical for the control of Salmonella, with the focus of control being directed at the top of the production pyramid with additional measures for the downstream components. The relative importance of different sources of Salmonella infections in the food production chain, such as the impact of Salmonella in livestock feed, can vary from country to country. The increasing trend of Salmonella Enteritidis (SE) in the food production continuum in Canada suggests opportunities exist to improve current programs, practices, and controls in place for SE. As a result, there are two joint federal, provincial and territorial (FPT) initiatives; the Pathogen Reduction Initiative (PRI) and the joint Government/Industry Salmonella Enteritidis Working Group (SE WG). These initiatives exist with an overarching goal to strengthen the Canadian food safety system on a supply chain ("farm-to-fork") basis by advancing work in the reduction of pathogens, including Salmonella, in meat and poultry. Feed has been included in one of the initiatives.

There have been a number of historical reports and scientific publication which have established with some confidence a direct link from human salmonellosis cases back through foods of animal origin to livestock feeds. Some studies have also linked livestock feed to the international dissemination of 'epidemic' strains of Salmonella such as S. Typhimurium DT104. Animals consuming Salmonella-contaminated feeds may be affected, acquiring transient infections (asymptomatic carriage) and occasionally acquiring clinical disease. The most common consequence of feeding animals with contaminated feeds is asymptomatic carriage which allows the establishment of Salmonella in farm environments. This contributes to the dissemination of Salmonella contamination to other close environments and the transmission of infection among livestock animals. From an animal health perspective, host-specific Salmonella spp. serotypes S. Pullorum and S. Gallinarum cause high mortality diseases known as pullorum disease and fowl typhoid, respectively, and can result in significant economic impacts on the poultry industry. Both of these diseases are specific to birds and pose a low risk to human health.

Salmonella is by far the most significant bacterial pathogen that can be present in livestock feeds. All feeds may be contaminated with Salmonella but some feeds and feed ingredients, such as rendered products, oilseed meals, fish meals, and non-heat treated feeds (e.g., mash feeds) typically have higher levels of Salmonella contamination than others. Data from 25 years of monitoring for Salmonella as part of CFIA's National Feed Inspection program, as well as information from literature, show Salmonella in feeds continues to be detected and that plant and animal protein sources are more frequently contaminated with Salmonella than other single ingredient feeds. Salmonella contamination of feed ingredients may occur at a variety of points during harvesting, processing, transport or storage of feeds. Recontamination following feed manufacturing steps where high temperatures are applied has been found to occur in certain feed ingredients of both animal or plant origin. Salmonella is a ubiquitous organism and feed manufacturers do not generally operate under sterile, low-moisture conditions, which are important to control the presence of Salmonella. Salmonella monitoring programs from various countries have highlighted that by applying good manufacturing practices and process controls in feed manufacturing, production of Salmonella negative feeds in a commercial feed industry setting is possible.

Given the implications of Salmonella in the food production chain, the CFIA has enforced a longstanding policy which states that livestock feeds shall not contain Salmonella. This policy is applicable to both the pre-market and post-market activities. During the pre-market assessment process, if Salmonella is reported as present in the feed under review, the feed cannot be approved. As part of the National Feed Inspection Program, if Salmonella is detected in feed samples during the various monitoring programs, the feed is considered non-compliant.

Scope of the Reviews

Current standards and action levels, as well as scientific literature, were reviewed to guide the establishment of a regulatory standard. The standard is based on the assessment of the impacts of the biological contaminants on animal health and production, human health, including food safety and worker/by-stander exposure, and the environment.

Information sources used in these reviews included:

  • research published in peer–reviewed literature;
  • data and information collected from CFIA domestic surveillance programs; and,
  • standards established by other national authorities and regulatory agencies (e.g. USFDA, EFSA).

Proposal

Given the potential negative impacts described above associated with the presence of mycotoxins and Salmonella in livestock feeds, there remains a need for enforceable regulatory standards in the modernized regulatory framework. Therefore, it is proposed that:

  • maximum levels will be established in the Regulations for livestock feed ingredients and/or total livestock diets, as applicable, for the following biological contaminants: aflatoxins, deoxynivalenol, fumonisins and ergot alkaloids; and,
  • an outcome based standard for Salmonella be added directly to Section 19 of the Feeds Regulations, indicating that feeds shall not contain Salmonella likely to be deleterious to livestock or present a risk to human health.

It is further proposed that:

  • standards for the mycotoxins described in this proposal (aflatoxin, deoxynivalenol, fumonisins and ergot alkaloids) be incorporated by reference in the Regulations, thus providing greater flexibility in amending the standards and proposing additional standards as scientific knowledge and evidence becomes available. Incorporation of documents by reference is a drafting technique that brings the content of a document into a regulation, without the need to reproduce the document in the regulation itself. The CFIA has developed the Incorporation by Reference Policy to articulate a clear and comprehensive process for identifying documents that could be incorporated by reference.

Appendix I outlines the proposed maximum contaminant levels in feed.

These standards would apply to feeds manufactured or imported for domestic use. In addition, and as outlined in the CFIA's 2015 Consolidated Modernized Framework Proposal, all feeds manufactured in Canada intended for export would need to meet Canadian standards for safety and other domestic compliance requirements. Feeds for export or feeds manufactured to be compliant with food export programs may be subjected to additional importing country or export program requirements.

Anticipated Outcomes

This modernized regulatory approach to setting maximum limits for mycotoxins and Salmonella contamination in a document incorporated by reference in the regulations will:

  • allow the CFIA to maintain regulatory oversight for hazards that may negatively impact human health, animal health and/or the environment;
  • provide stakeholders with clear standards, referenced in the Regulations, for identified hazards;
  • allow for timely updates to the standards as new information for specific contaminants are provided;
  • harmonize, to the extent possible, with other jurisdictions such as the U.S. and European Union; and,
  • assure that domestic feeds and those in international trade originating from Canada are as safe as possible.

It is important to note that while maximum levels are being proposed for specific biological contaminants, this is not an exhaustive list and other biological and chemical contaminants will be discussed in other proposals. Feed manufacturers are reminded of their responsibility to produce feeds which are safe for all classes of livestock species and to prevent the introduction of contaminants into the food chain via foods of animal origin. The identification of specific contaminants which, represent a hazard if not adequately controlled, is critical for the development of preventative control plans.

References: A complete bibliography is available upon request.

Have your say

The CFIA is seeking feedback on the proposal to modify the regulatory requirements related to mycotoxin and Salmonella standards in livestock feed:

  • Do you have any concerns with the proposal to establish maximum mycotoxin levels, specifically for aflatoxins, deoxynivalenol, fumonisins and ergot alkaloids in the modernized Regulations for livestock feed?
  • Do you have any concerns with the proposed maximum mycotoxin values outlined in Appendix I? Is there valid scientific information that may have been overlooked?
  • Do you have any concerns with the proposed policy for Salmonella for livestock feeds? Is there valid scientific information that may have been overlooked?
  • Would the proposed amendments to the Feeds Regulations be effective in protecting human and animal health and the environment?
  • Are there other options not mentioned in this proposal that should be explored?
  • Any additional feedback?

We strongly encourage you to provide your input and feedback, which is critically important to the success of the regulatory modernization initiative. Written comments may be forwarded by September 22, 2017 to:

Sergio Tolusso
Canadian Food Inspection Agency
Animal Feed Division
59 Camelot Drive
Ottawa, ON K1A 0Y9
Email: Sergio.tolusso@inspection.gc.ca
Fax: 613-773-7565

Appendix I – Proposed Maximum Contaminant Levels in Feeds

Aflatoxins

Aflatoxins are associated with a wide range of food commodities, but significant amounts may occur in maize. Aflatoxins can cause serious health effects. They are potent toxins which are toxigenic, carcinogenic, mutagenic, and teratogenic in various animal species. Aflatoxins from feed are readily transferred to milk and other animal products, and as such could present a food safety issue. Aflatoxins are highly stable toxins that are resistant to heat, cold, and light. The proposed and current maximum levels for aflatoxins are presented in Table 1.

Table 1: Proposed and current maximum levels for aflatoxins
Species/Class of Animal Proposed Maximum Limit:
Single ingredient feeds in an amount not exceeding
(ppb Table Note 1)
Proposed Maximum Limit:
Total diet, in an amount not exceeding
(ppb)
Current Maximum
Limit: Table Note 2
All feeds, in an amount not exceeding
(ppb)
All 20 20 20

Table Notes

Table Note 1

ppb = parts per billion, 10−9 (1 milligram / 1,000 kilograms)

Return to table note 1 referrer

Table Note 2

Current maximum limit = as per Section 19 of the Feeds Regulations

Return to table note 2 referrer

Rationale:

  • It is proposed to maintain the 20 ppb aflatoxins level for Canada. This level provides protection to livestock throughout their lifecycle, humans from possible harmful aflatoxins in food products, and the environment from contamination. Aflatoxins have not been detected in crops grown in Canada. Sources of contaminated products imported in the country are typically from single ingredients, primarily corn products, where the intended livestock species in unknown. These maximum levels are supported in current scientific literature in animal rearing practices, animal toxicity data, animal physiology and productivity, food safety as well as monitoring data for aflatoxins in Canada.
  • Aflatoxins are stable and resistant to abiotic stresses such as heat, cold and light. In addition, mycotoxins are not distributed evenly in grains and hot spots of contamination can occur. As there is potential to increase aflatoxin levels during storage, blending of feed ingredients in order to dilute the concentration in feed is not permitted. The "no-blending" policy is also present in other jurisdictions.
  • As with Canada, the USFDA and the EU have published standards for aflatoxins in their respective regulations. There are differences in standard levels in all jurisdictions depending on the animal species and type of ingredient being fed (e.g., cottonseed meal and peanut products depending on animal species in the USA vs young animals in the EU). However, levels are the same or similar for feed ingredients and species in situations where the intended use is unknown.

Deoxynivalenol (DON)

Deoxynivalenol (DON), commonly known as vomitoxin, is primarily produced in cereal crops including wheat, maize, and barley, prior to harvest. DON is of growing concern in Canada due to its increased prevalence in domestic and imported cereal crops. For humans, the health risk from transfer of DON to animal products (milk, meat and eggs) from exposure to DON contaminated feed is insignificant. However in farm animals, DON is considered a major cause of economic losses due to decrease in value of contaminated feeds, reduced animal performance, immuno-suppression and gastrointestinal problems. Among the livestock animals, pigs and young calves are most sensitive to DON while poultry, horses, and ruminants are more tolerant. Lactating dairy cattle are more susceptible than beef cattle due to additional stress levels. The proposed and current maximum levels for DON are presented in Table 2.

Table 2: Proposed and current maximum levels for deoxynivalenol
Species/Class of Animal Table Note 3 Proposed Maximum Limit:
Single Ingredient Feeds (e.g., cereals and cereal by-products),
in an amount not exceeding
(ppm Table Note 4)
Proposed Maximum Limit:
Total Diet
in an amount not exceeding
(ppm)
Current Action
Level: Table Note 5
Complete diets, in an amount not exceeding
(ppm)
Cattle - calves (<4 months) 5 1 1
Cattle - Beef 10 5 5
Cattle - Dairy 10 5 5
Lactating Dairy Animals 5 1 1
Swine 5 1 1
Poultry: chickens, turkeys, ducks 10 5 5
Other animals including sheep, equine and rabbits 10 5 No action levels established

Table Notes

Table Note 3

There is insufficient data to support setting a standard for fish feeds. Although a standard is not being proposed at the present time, the Regulations will still require that feeds are safe for human and animal health and any detections of the contaminant in fish feeds can be assessed for risk of harm on a case-by-case basis.

Return to table note 3 referrer

Table Note 4

ppm = parts per million, 10−6 (1 milligram / 1 kilogram)

Return to table note 4 referrer

Table Note 5

Current action level = as per RG-8 Regulatory Guidance: Contaminants in Feed

Return to table note 5 referrer

Rationale:

  • Limits in feed ingredients are based on maximum inclusion rates and on 88% dry matter basis
  • DON is considered a major cause of reduced animal performance, reproductive effects, immuno-suppression and gastrointestinal problems.
  • The proposed DON standards for animal feed are similar with those established by the USFDA and European Union guidance levels. The differences in proposed levels are based on current scientific literature in animal rearing practices, animal toxicity data, animal physiology and productivity.
  • The levels being proposed for the total diet are the same to the current action levels specified in RG-8 Regulatory Guidance: Contaminants in Feed.

Fumonisins

Fumonisins are found worldwide, predominantly as contaminants of maize. They are prevalent in both domestic and imported maize and cereal/cereal by-products. They are responsible for major economic losses due to: crop yield loss, reduced crop value and losses in animal productivity. Although the transfer into animal products such as milk, meat and eggs is not significant, fumonisins have the potential to be detrimental to animal health. The primary health concerns associated with fumonisins are acute toxicity and carcinogenicity in livestock (e.g., horses and swine). Fumonisins may cause reduced feed intake, liver damage, and a fatal disease known as pulmonary edema in swine. The proposed and current maximum levels for fumonisins are presented in Table 3.

Table 3: Proposed and current maximum levels for fumonisins
Species/Class of Animal Table Note 6 Proposed Maximum Limit:
Single Ingredient Feeds (e.g., cereals and cereal by-products), in an amount
not exceeding
(ppm Table Note 7)
Proposed Maximum Limit:
Total Diet
in an amount not exceeding
(ppm)
Current Action
Level: Table Note 8
Complete diets, in an amount not exceeding
(ppm)
Horses 5 1 No action levels established
Rabbits 5 1 No action levels established
Swine 20 10 No action levels established
Ruminants (Beef cattle, dairy cattle, sheep and goats and other ruminants that are >4 months old and fed for slaughter) 60 30 No action levels established
Ruminants (Breeding - bulls, lactating dairy cattle) 30 15 No action levels established
Poultry (Turkeys, chickens, ducklings and other poultry fed for slaughter) 100 50 No action levels established
Poultry (Laying hens and roosters for breeding stock) 30 15 No action levels established

Table Notes

Table Note 6

There is insufficient data to support setting a standard for fish feeds. Although a standard is not being proposed at the present time, the Regulations will still require that feeds are safe for human and animal health and any detections of the contaminant in fish feeds can be assessed for risk of harm on a case-by-case basis.

Return to table note 6 referrer

Table Note 7

ppm = parts per million, 10−6 (1 milligram / 1 kilogram)

Return to table note 7 referrer

Table Note 8

Current Action Level = as per RG-8 Regulatory Guidance: Contaminants in Feed

Return to table note 8 referrer

Rationale:

  • Limits in feed ingredients are based on maximum inclusion rates and on 88% dry matter basis.
  • Fumonisins are responsible for crop yield losses, reduced crop value and losses in animal productivity.
  • Proposed standard levels are considered protective for animal health.
  • Although the transfer into animal products such as milk, meat and eggs is not significant, FB-1, one of the abundant forms of the mycotoxin, can be nephrotoxic and hepatotoxic in livestock.
  • The proposed fumonisins standards for animal feed are in line with those established by the USFDA and similar to the European Union guidance levels. Most differences in proposed levels are due to grouping livestock in more general categories (EU) vs separating the animals by breeding vs non-breeding (Canada). These standards are based on current scientific literature in animal rearing practices, animal toxicity data, animal physiology and productivity.

Ergot Alkaloids (EAs)

Ergot alkaloids (EAs) produced by fungi are stored in the ergot sclerotia or ergot bodies. The total ergot alkaloid content produced can vary among fungal species, the type of cereal grain and environmental conditions. Thus, ergot alkaloid concentrations are a better indicator of potential toxicity in livestock species than ergot bodies. Ergot alkaloids are mycotoxins and are toxic to human and animals causing a disease called "Ergotism" if they are consumed in sufficient amounts. Ergot toxicity can result in a convulsive form (symptoms can be seizures, staggering, confusion, hallucinations or partial paralysis) and/or gangrenous form (symptoms can be impaired blood circulation and loss of blood supply to extremities). Early symptoms may include elevated respiration rate, weight loss, reduced milk production and adverse effects on reproduction system. Based on limited available information from published scientific literature, EAs are unlikely to transfer from the feed into foods of animal origin (i.e., eggs, meat and milk) and unlikely for foods of animal origin to be a main source of human exposure to EAs. In recent years, a significant increase of cases of ergot contaminated crops in Western Canada has been reported. The risk of ergot poisoning in livestock species may increase as a result of consuming contaminated cereal grains or feeds containing the contaminated cereal grains. The proposed and current maximum levels for EAs are presented in Table 4.

Table 4: Proposed and current maximum levels for total ergot alkaloids
Species/Class of Animal Table Note 9 Proposed Maximum Limit:
Single Ingredient Feeds (e.g., cereals and cereal by-products), in an amount
not exceeding
(ppm Table Note 10)
Proposed Maximum Limit:
Total Diet
in an amount not exceeding
(ppm)
Current Action
Level: Table Note 11
Complete diets, in an amount not exceeding
(ppm)
Weaned piglets 3 1 4
Growing-finishing pigs and sows 6 2 4
Poultry 6 2 6
Cattle 2 1 2
Sheep 0.6 0.3 2
Horses 0.3 0.15 2

Table Notes

Table Note 9

There is insufficient data to support setting a standard for fish feeds.  Although a standard is not being proposed at the present time, the Regulations will still require that feeds are safe for human and animal health and any detections of the contaminant in fish feeds can be assessed for risk of harm on a case-by-case basis.

Return to table note 9 referrer

Table Note 10

ppm = parts per million, 10−6 (1 milligram / 1 kilogram)

Return to table note 10 referrer

Table Note 11

Current Action Level = as per RG-8 Regulatory Guidance: Contaminants in Feed

Return to table note 11 referrer

Rationale:

  • Lower maximum levels in the total diet are being proposed for all species as compared to the action levels specified in RG-8 Regulatory Guidance: Contaminants in Feed. The new proposed levels are based on current scientific literature considering primarily animal health, performance and productivity (e.g., decreases in feed intake and reduced weight gain).
  • Maximum levels for total ergot alkaloids, rather than for individual ergot alkaloids, are proposed considering the following:
    1. Livestock are likely to be exposed to a complex mixture of ergot alkaloids.
    2. The proportion of individual alkaloids, including ergotamine, ergocristine, ergosine, ergocornine, and ergocryptine, is extremely variable within ergot bodies, greatly depending on the geographic region, harvest year, cereal species, variety, and genotype.
    3. Data on the sensitivity of livestock towards individual ergot alkaloids is incomplete.
    4. New alkaloids are continually discovered further increasing the complexity of defining the toxicity of ergot.
  • Maximum proposed tolerance levels for total ergot alkaloids are proposed for cereals and cereal by-products and on a total diet basis and, assuming:
    1. Livestock are likely to be exposed to a complex mixture of ergot alkaloids.
    2. The pattern of alkaloids, including the composition of individual alkaloid and its "-ines" and "-inines" form, has no impact on the toxicity.
    3. Processing factors have no impact on the toxicity.
    4. No synergistic (or antagonistic) effects were presented among ergot alkaloids or between ergot alkaloids and other fungal toxins present in the diet.

Salmonella

The CFIA proposes to introduce a specific requirement into Section 19 of the draft amended Feeds Regulations with a standard to the effect,
"… a feed shall not contain …
(xx) Salmonella that presents a risk of harm to human or animal health or the environment."

This standard would be supported by a policy that livestock feeds should not contain Salmonella. If Salmonella is detected in feed samples via routine monitoring programs, the feed will be considered non-compliant. If, during any pre-market assessment process for a feed or feed ingredient requiring CFIA registration or approval, Salmonella is reported as present in the feed under review, the feed cannot be registered or approved. The applicant would need to modify its manufacturing process to ensure that the feed meets the standard.

To support this standard, the CFIA would envision continuing to have Salmonella sampling programs which would consist of two well-defined components. The first is monitoring sampling, which probes the feed supply for potential contamination. The second is directed sampling which focuses on regular testing at facilities that have repeatedly tested positive for Salmonella or have tested positive for a Salmonella serotype that routinely affects humans. These sampling programs play a role in surveillance programs aimed at developing control strategies in livestock production. If Salmonella contamination under either the monitoring or directed sampling programs is detected, corrective actions are required by the facility to address the current situation and to mitigate contamination reoccurrence. Management measures to protect human and animal health from risks associated with any detection of Salmonella in livestock feed would be determined by CFIA on a case-by-case basis using all available information. Risk mitigation factors such as Salmonella serotype, species of animal the feed is intended for, type and form of the feed, re-processing conditions (if applicable) and quantities of feed would remain elements to consider during the analysis of an acceptable appropriate response plan in a situation of non-compliance.

This policy on Salmonella in feed would be developed and made available for public review and comment in association with the pre-publication of the proposed modernized Regulations in the Canada Gazette, Part I.


Rationale:

  • Salmonella spp. are considered to be one of the major causative agents of human bacterial gastroenteritis and bacteremia and has led to morbidity and mortality in humans around the world.
  • Feed can be a route of exposure for Salmonella in the feed and food chain.
  • The proposed outcome-based standard and policy approach consider both animal health and food safety aspects.
  • It is recognized that multiple interventions, controls, and programs constituting a farm-to-fork supply chain approach, which includes controlling Salmonella in feed, will be critical for the control of poultry-related SE illness in Canada. This proposed standard supports the National Strategy for the Control of Poultry-Related Human Salmonella Enteritidis Illness in Canada.

Approaches being taken in other jurisdictions

In Europe, Salmonella strategies vary from country to country:

  • The European Commission has enacted a few regulations that pertain to microbiological criteria in feed and that feed shall not be placed on the market or fed to any food-producing animal if it is unsafe. No specific criteria regarding Salmonella have been adopted by the Commission.
  • Nordic countries such as Sweden take more of a zero tolerance approach to Salmonella contaminated livestock feeds while other European countries will have risk management strategies that include treating contaminated livestock feeds if appropriate. The latter is similar to the current and proposed strategy for Canada.

In the US, the Food and Drug Administration (FDA) published a compliance guide for FDA staff entitled "Compliance Policy Guide Sec. 690.800 Salmonella in Food for Animals" in 2013. The purpose of this document is to provide guidance for FDA staff on the presence of Salmonella in food for animals. This guidance describes FDA's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

  • In this guide, the FDA considers an animal feed or pet food that may be injurious to health because it is contaminated with Salmonella to be adulterated under section 402(a)(1) of the FD & C Act (21 U.S.C.. 342(a)(1)). Given the variability in the potential risk that such contamination may pose to human and animal health, FDA's policy for prioritizing regulatory action takes into account certain risk-based criteria, including the type of food for animals that is involved. The FDA further refines this policy statement for Salmonella contaminated animal feed to serotypes pathogenic to animals. They state that FDA considers an animal feed to be adulterated under section 402(a)(1) of the FD & C Act when it is contaminated with a Salmonella serotype that is considered pathogenic to the animal intended to consume the animal feed and the animal feed will not subsequently undergo a commercial heat step or other commercial process that will kill the Salmonella.
    • FDA's policy statement for animal feeds varies from CFIA's current proposal as considerations for animal health as well as food safety were used in establishing Canada's standard.
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