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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:

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:

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:

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:

It is further proposed that:

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:

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:

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:

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:

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:

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:

Approaches being taken in other jurisdictions

In Europe, Salmonella strategies vary from country to country:

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.

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