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What we heard report – Consultations on maximum chemical contaminant levels in livestock feeds

Respondent Comments
and CFIA Responses

August 14 – September 22, 2017

On this page

Purpose

This report consolidates and summarizes the comments received regarding the Canadian Food Inspection Agency's (CFIA) Proposal – Maximum Chemical Contaminant Levels in Livestock Feeds and the CFIA's response to those comments.

Introduction

Building on considerable consultation, research, design and planning work completed over the past few years to continuously improve how the CFIA does business; the Agency is moving forward on five strategic priorities to help safeguard food, animals and plants in order to enhance the health and well-being of Canada's people, environment and economy.

To maximize the Agency's capacity to respond to risk now and into the future, all work being done by the CFIA will align with the these five priorities:

  1. Modern Regulatory Toolkit – The CFIA's modern regulatory toolkit, which focuses on outcome-based regulations with new compliance promotion tools, supports the Agency's role in protecting Canada's food, plants and animals, while facilitating product innovation.
  2. Integrated Risk Management – The CFIA's decisions and actions are based on risk and science. The Agency's new risk management tools; analytics and surveillance contribute to informed resource allocations and enforcement priorities while also bolstering the CFIA's ability to adapt quickly and respond to emerging risks in a changing global environment.
  3. Consistent and Efficient Inspections – A single inspection approach focused on regulatory outcomes and effectiveness of industry controls, supported by guidance and mobile tools, will contribute to greater efficiency and agility for the Agency when responding to emerging risks.
  4. Digital-First Tools and Services – Electronic access as the preferred method of requesting and receiving services from the CFIA, through applications such as My CFIA and Ask CFIA, will support industry compliance with regulatory requirements while helping to manage and prevent food safety risks.
  5. Global Leader – The CFIA's collaboration with partners around the world will support the development of international rules and standards, fairness in trade practices, enhanced use of technology, increased regulatory cooperation and improve market access for industry.

The modernization of the Feeds Regulations (Regulations) is taking these priorities into account in order to benefit the collective Canadian feed industry, which includes livestock producers, commercial feed manufacturers, retailers, importers, exporters, ingredient manufacturers, and food processors. In addition to aligning with other international feed regulatory regimes, modernization also maintains the objective of ensuring the regulations are as outcome-based, efficient and flexible as possible while also continuing to ensure feeds are safe and contribute to the production and maintenance of healthy livestock, safe foods of animal origin, and that they do not pose a significant risk to the environment.

The oversight of chemical contaminants in feeds is just one aspect of the Regulations that is being reviewed as part of the comprehensive modernization project. The CFIA verifies that livestock feeds manufactured, sold in, and imported into Canada are safe, effective and labelled appropriately. The CFIA uses a variety of measures including pre-market assessments and marketplace inspection activities including product sampling and testing to verify compliance with standards and to monitor for the presence of known chemical contaminants.

While fluorine is the only chemical contaminant having standards specified in the current Regulations, a pair of more outcome-based provisions have given the CFIA scope to identify and provide guidance on other chemical contaminants in feeds and feed ingredients. Section 19(1) of the Regulations states:

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

(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."

To provide greater clarity to 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, example, dioxins and heavy metals, in the publication RG-8 Regulatory Guidance: Contaminants in Feed.

About the consultation

The CFIA undertook a Consultation from August 14, 2017 to September 22, 2017 to propose maximum levels in the regulations for livestock feed ingredients and total livestock diets, as applicable, applied to the following chemical contaminants:

The proposal also indicated that these maximum chemical contaminant levels would be included in a document to be incorporated by reference in the regulations to allow the flexibility to amend the level(s) in a timely manner, as necessary.

The proposal followed through on a commitment made in the CFIA's 2015 Consolidated Proposal to provide regulated industry with a list of known or reasonably foreseeable chemical hazards in feeds to inform their hazard identification and preventive control plans; and makes use of the authority in the Feeds Act that allows the CFIA to incorporate such technical standards by reference in the modernized regulatory framework.

The primary mode of consultation involved the preparation and posting of the Proposal – Maximum Chemical Contaminant Levels in Livestock Feeds – on the CFIA website, and outreach directly to industry stakeholders, government partners and CFIA staff. 26 sets of written comments were received in response to the maximum chemical contaminant levels in livestock feeds proposal.

This report consolidates and summarizes the comments received on the maximum chemical contaminant levels in livestock feeds proposal and the CFIA's response to those comments.

The CFIA would like to thank everyone who participated in the consultation for contributing their time to the consultation process and sharing their views.

What we heard

Respondent profile

Table 1: Respondent profile
Category of respondent Distribution
Commercial Feed Industry – Individuals 7
Commercial Feed Industry – Associations 2
Ingredient Suppliers – Individuals 1
Ingredient Suppliers – Associations 3
Livestock Producer – Individuals 0
Livestock Producer – Associations 3
Academic 1
Other Feed Inputs 7
Government (Canadian Federal/Provincial) 2
Total 26

The feed industry association comments represent Canadian and American commercial feed manufacturers, as well as some larger feed ingredient supplier organizations. The Canadian feed manufacturers association represents 90 percent of commercial feed manufactured in Canada, while the US association represents about 75 percent of commercial feed manufactured in the US. The "Other Feed Inputs" listed in the table above included responses from the general public, economic development organizations and consulting firms.

Key respondent messages

Stakeholders indicated they agreed with the concept of establishing maximum chemical contaminant levels in the Regulations, however, they also raised some concerns regarding the proposal, including:

CFIA response

With respect to these key respondent messages, the CFIA has reflected further on the suitability and timing of including all of the identified contaminants and the respective proposed maximum levels into the modernized regulatory framework via a document for incorporation by reference. These considerations include:

  • with regards to considerations related to a contaminant, the
    • scientific soundness of the proposed standard
    • international alignment of the proposed standard
    • availability, access and suitability of analytical methodologies that would enable regulated parties to monitor for the presence of the contaminant in ingredients and mixed feeds
    • availability of surveillance data to benchmark current compliance rates
    • equity of enforcement for products in domestic, import and export trade
  • with regards to considerations related to the risk management of a contaminant, the
    • adequacy of current compliance rates
    • achievability of compliance by regulated parties along the supply chain
    • availability of reasonable risk management measures to respond to situations where the contaminant is present in the supply chain

Having given careful consideration to each of these criteria, with the exception of total polychlorinated biphenyls (PCBs) the CFIA plans to move forward with including all of the contaminants identified and the respective maximum levels set out in this summary report into the modernized regulatory framework.

A more detailed discussion about contaminant-specific feedback and concerns received from respondents and the CFIA's response follows below.

Contaminant specific feedback on proposed maximum levels

Dioxin, Furans and Dioxin-like PCBs

The proposal included a table displaying proposed maximum levels for dioxins, furans and dioxin-like PCBs in the following livestock feed ingredients:

10 respondents provided comments regarding the levels proposed for dioxins, furans, and dioxin-like PCBs. 8 respondents felt the maximum levels were inappropriate and commented that

1 respondent went on to further comment that the US has not set maximum dioxin levels in their regulations and suggested the levels proposed by the CFIA would not only cause significant trade barriers but would contravene the NAFTA sanitary/phytosanitary obligations of the Canadian government.

3 respondents provided suggestions for establishing maximum contaminant levels including, ensuring maximum levels are set using safety and/or risk assessments of specific ingredients which are conducted according to CODEX (PDF 298 kb) guidelines and are based on levels indicated on the product's labels. One of these respondents further suggested that CODEX recommends that bioavailability of contaminants in different matrices be considered.

Two (2) of these respondents agreed with the proposed levels for anti-caking agents and vegetable oils and their by-products, however, provided suggestions on amending the remaining levels as follows:

Table 2: Dioxin, Furans and Dioxin-like PCBs
Ingredient CFIA proposed levels Stakeholder suggested levels
Fish Meal 2.5 ng WHO-TEQ/kg 4.0 ng WHO-TEQ/kg
Fish Oil 12 ng WHO-TEQ/kg 20.0 ng WHO-TEQ/kg
Mineral Feed Ingredients 1.0 ng WHO-TEQ/kg 1.5 ng WHO-TEQ/kg

2 respondents also expressed concern over the interpretation challenges that exist in the quantification of dioxin congeners and suggested the establishment of maximum limits for the 29 dioxin congeners in the Regulations would be necessary.

CFIA response

International and national recognition of dioxins as feed, food, and environmental hazards and their associated risk assessments

Dioxins are Recognized as Feed and Food Hazards Around the World

Internationally and domestically, dioxins are identified as persistent, bioaccumulative and toxic contaminants and hazards in the food chain by food safety and animal health organizations including:

Dioxins accumulate in people when they are exposed and over time can cause reproductive and development problems, damage to the immune system, interfere with the endocrine system and can cause cancer.

International and National Risk Assessments for Dioxins – Environmental Contaminants in Feed and Food

International and national assessments associated with dioxin exposure have been conducted considering various exposure pathways including both environmental and human health assessments:

In 2002, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) established a provisional tolerable intake of 70 pg/kg body weight per month for dioxins, furans and coplanar PCBs expressed as TEFs (Toxic Equivalent Factors). Health Canada provides reference to this as the Tolerable Monthly Intake of 70 picograms TEQ/kg-bw which corresponds to approximately 2.3 pg-TEQ/kg-bw/day (Health Canada) (A tolerable weekly intake of 14 pg TEQ/kg-bw is referenced by the European Commission Dabeka et al. (2013) and most recently in 2012 the US Environmental Protection Agency derived an oral reference dose of 0.7 pg-TEQ/kg-bw/day (Additional food dioxin data from Health Canada's Food Directorate – 2000 to 2004 and 2010).

These international and national risk assessments and health based guidance values point to dioxin intake from the consumption of foods of animal origin accounting for well over 90 percent of the body-burden of dioxins in people. In addition, it is estimated that livestock feeds contribute 80 to 90 percent of these food contaminants. Risk management is recommended to address accumulation. These data and assessments from around the world form the scientific and risk basis for developing risk management strategies to address the presence of dioxins in feeds.

Between 1992 and 1999 the Canadian Total Diet Study (TDS) assessed the intake of dioxins by different age-sex groups of Canadians. The most recent results available on Health Canada's webpage from 1999, based on foods collected in Calgary, indicate that while on average intake estimates were 0.60 pg-TEQ/kg-bw/day the range for different sub-groups spanned 0.34 to 2.12 pg-TEQ/kg-bw/day with children (aged 0-11 years) having exposures in excess of 1.30 pg-TEQ/kg-bw/day. Since then the Canadian TDS has continued, although data have not been made available on Health Canada's website and dioxins are not tested every year. The CFIA requested additional food dioxin data from Health Canada's Food Directorate which the CFIA has combined with previously available TDS data and has conducted some trend analysis which depicts decreasing levels of dioxins in foods of animal origin. Health Canada is currently analyzing these data to generate dietary intakes of dioxins (among other contaminants) for different age-sex groups of Canadians. Dabeka et al. (2013) reviewed dietary contributions of dioxins from the 2005 total diet study which revealed that milk, dairy, meat, and poultry products contribute 92 percent of total dioxin and dioxin-like PCB exposure in children aged one to four years old. Likewise, reductions in food residues of dioxins have also been reported in Europe correlated to the setting of standards in feeds and food and associated monitoring and enforcement activities.

The setting of dioxin standards in guidance for feeds
Risk management objective

The CFIA's goal in setting the standards for dioxins in feed ingredients is to continually reduce sources of contaminants in feeds and, in turn, food. This objective aligns with that of international food safety and animal health bodies. It is recognized that the ingredients and products that may contain contaminants are used differently for different purposes at different inclusion rates. The magnitude and frequency of exposure to different functional classes of ingredients as well as the availability of alternative nutritional and functional sources is a factor that has been considered. Ingredients that are used intermittently or infrequently in feeds versus those that are used in all feeds for all livestock species result in different exposure profiles. Continuous exposure, even at low inclusion rates, provides for the bioaccumulation of contaminants like dioxins in edible tissues throughout the production life of the animal.

The current levels described in RG-8 and the proposed maximum levels for the Regulations represent risk management tools. They have been established using the "as low as reasonable achievable" (ALARA) principle recognizing that, due to their ubiquitous nature, their absolute elimination from the feed and food supply chain is impractical and impossible. Limits have been established based on levels of contaminants in feed ingredients around the 90th to 95th percentile of the distributions from data obtained from sampling programs. This risk management strategy serves to keep the most contaminated products out of the marketplace and allows for the monitoring, tracing, and if necessary removal of remaining sources. The approach also takes into account the availability of ingredients in the marketplace that are not considered contaminated.

The resulting decrease in levels of dioxins in the feed chain and foods of animal origin should then support further reductions of the maximum levels within a number of years and gradually reduce the exposure of Canadians from foods of animal origin. This approach is not unique to Canada and is being employed by regulators and risk managers when dealing with ubiquitous, persistent, bioaccumulative, and toxic chemicals. These properties associated with dioxins in the feed and food chain means that many types and classes of ingredients are potentially contributing to exposure. As such, limiting the contribution to dietary exposure of these contaminants for individual ingredients or functional classes to fractions of the tolerable daily intake or health based guidance value is reasonable and rational.

Bioavailability and bioaccessibility considerations

In the context of chemical contaminants, oral bioavailability is the fraction of the ingested contaminant that reaches systemic circulation where it is then available to be distributed further in the body to a site of action (bioactivity) or stored (bioaccumulation). Bioaccessibilty is a component of bioavailability defined as the quantity of a compound that is released from its matrix in the gastrointestinal tract, becoming available for absorption into systemic circulation.

Typically, bioaccessibilty is evaluated by in vitro digestion procedures, generally simulating human gastric and small intestinal digestion and sometimes followed by a measure of in vitro cellular uptake. While bioaccessibility is a growing area of research in the field of risk assessment, bioaccessibility values derived from in vitro studies still require validation from in vivo studies. Furthermore, the applicability of current human-based models to gastrointestinal tract variability and complexity of livestock species including ruminants (example, cattle and sheep), hindgut fermenters (example, horse and rabbits), poultry with their crop and gizzard, and fish is questionable.

Taking a conservative approach to the bioavailability and bioaccessibilty of complex mixtures like dioxins, from different matrices, for the protection of animal and public health when considering a bioaccumulating toxic chemicals like dioxins is warranted. Additionally, unabsorbed dioxins result in the further environmental distribution of these persistent, bioaccumulative, and toxic priority contaminants that have been identified for control and elimination by Environment and Climate Change Canada.

Analytical testing and interpretation

The proposed maximum levels set for dioxins, furans and dioxin-like PCBs refer to 29 congeners, which include the 7 dioxin congeners, 10 furan congeners and 12 dioxin-like PCB congeners referenced in the associated proposed IBR document. The congener specific toxic equivalency factors (TEFs) set by the WHO in 2005 used to calculate the total upper bound TEQ were also included in the proposal. Setting maximums for each congener is not the internationally accepted practice for the evaluation of dioxin toxicity or exposure and as such will not be undertaken.

The availability of analytical testing services and the analytical reporting provided by these services are routine and standard in accredited laboratories including:

  • results for the full list of dioxin, furan, and dioxin-like PCB congeners
  • calculation of their toxic equivalency (TEQ) using the 2005 WHO TEFs and
  • the calculation of the upper-bound TEQ concentrations accounting for non-detectable congeners
In summary
  • these scientific, risk-based proposed regulatory levels are part of the CFIA's risk management strategy to continually reduce unnecessary sources of contaminants in feeds and, in turn, food as 90% of human dioxin exposure is through foods of animal origin
  • the need to manage dioxins in the feed and food chain along with eliminating environmental releases is internationally recognized
  • the impacts of dioxin risk management activities including those in animal feeds in Canada and in Europe continue to demonstrate correlated impacts reducing food-borne dioxins
  • a conservative approach to the bioavailability and bioaccessibilty of complex mixtures like dioxins, from different matrices, fed to a variety of animal species, for the protection of animal and public health when considering bioaccumulating toxic chemicals like dioxins is warranted

Based on the comments received, the proposed revised maximum levels for dioxins, furans and dioxin-like PCBs in Appendix I will be moving forward into the Incorporation by Reference (IbR) document. Please note that the maximum levels are based on total weight (not based on moisture content or fat content).

Total Polychlorinated Biphenyls (PCBs) in Marine Oils

The CFIA received only 1 comment regarding the proposed maximum values for Total PCBs in marine oils. The respondent suggested that the CFIA should follow the European Union (EU) policies and focus on addressing 6 congeners as opposed to the guidance provided in RG-8 Regulatory Guidance: Contaminants in Feed which states that the "analysis for "Total PCBs" conducted by the CFIA is based on the combined concentration of 72 of the 209 individual PCB congeners". The respondent went on to suggest an amendment to the proposed maximum level from 0.3 mg/kg to 0.175 mg/kg to further align with the EU standards.

CFIA response

The CFIA agrees that setting a maximum standard for PCBs should be based on those that are routinely monitored, specifically the 12 dioxin-like PCBs and 6 indicator PCB congeners. As such, the CFIA will review additional literature and monitoring data on a congener specific basis to develop regulatory maximums for consultation at a later date.

Over the years, CFIA has monitored for total PCBs (69 to 72 of the possible 209 congeners) and will be comparing the percentage contribution of the 12 and 6 PCB congeners to the "total PCBs". Initial results indicate that the 35 to 50% of the total PCB concentrations were attributed to the 12 dioxin-like PCBs and 6 PCBs.

CFIA will revisit this standard at a later time linking indicator dioxin concentrations to overall dioxin monitoring and exposure data.

Arsenic, Cadmium, Lead and Fluorine

The table below provides a summary of respondent feedback to the proposed maximum levels for these elemental contaminants.

Table 3: Arsenic, Cadmium, Lead and Fluorine
Contaminant No. of respondents with comments No. in agreement with proposed values No. not in agreement – Summary of feedback
Arsenic (As) 2 2 0 – One respondent requested clarification on the supporting information in the proposal regarding elimination rates.
Cadmium (Cd) 2 0 1 – Suggested 1 mg/kg maximum Cd for cattle, sheep and goat feeds and a maximum Cd of 0.5 mg/kg for all other species.
1 – Suggested the EU levels for Cd of 1mg/kg for aquaculture be adopted.
Lead (Pb) 1 1 N/A
Fluorine (F) 1 0 1 – Suggested the CFIA align with the EU and implement a maximum F level of 350mg/kg for aquaculture feeds.

CFIA response

Arsenic

A specific question was asked about the elimination rate of inorganic arsenic which was reported as between 2 to 40 days. However, their veterinary experience indicates that elimination in animals is closer to the 2 days end of the scale while 40 days must be related to humans. This information was cited in Health Canada's 2006 Report entitled Guidelines for Canadian drinking water quality: Guideline technical document – Arsenic. This report states that "the half-life of inorganic arsenic in humans is estimated to be between 2 and 40 days" (Pomroy, C., Charbonneau, S.M., McCullough, S., and Tam, G.K.H. (1980) Human retention studies with 74As. Toxicol. Appl. Pharmacol., 53: 550.). It should be clarified that this range encompasses many processes across many forms of inorganic arsenic as it is absorbed, distributed, metabolized and excreted. Organic arsenic is absorbed proportionally to the intestinal concentration, suggesting simple diffusion while inorganic arsenic is sequestered in or on mucosal membranes with movement into tissues across a concentration gradient once saturation occurs. Intestinal bacteria can convert inorganic arsenic to organic arsenic through methylation. Excretion of ingested arsenic is principally by urinary excretion of inorganic arsenic in both the trivalent and pentavalent forms. The second involves the sequential methylation of As(III) in the liver to organic forms which are then excreted over the following 2-3 days including elimination through the biliary route. Less important, and the slowest route of elimination, involves its sequestration and removal in skin, hair, nails and sweat accounting for the 40 day end of the elimination estimate. These distribution and elimination phases from many compartments are not unique to humans and there are physiological and metabolic differences (example, ability to methylate arsenic) which may affect the absorption and the relative proportions of arsenic eliminated across the different routes and remaining in tissues. Typically the majority of all ingested inorganic arsenic is eliminated through rapid urinary excretion, and to a lesser degree through the biliary route. Remaining arsenic compounds distribute and redistribute with a very slow terminal phase involving sequestered arsenic in skin, hair, and nails etc.

Based on the responses received, the CFIA will proceed with the maximum of 8 mg/kg for arsenic identified in the proposal.

Cadmium

Based on the scientific data and other relevant information (related to the toxicity of cadmium to animal and human health) as well as sample monitoring data for cadmium in feed, the current maximum levels of cadmium in the total diet of terrestrial livestock species will remain unchanged.

For fish, sampling data for marine-based feed ingredients, such as fish meal, show potential for elevated cadmium. This information combined with fish meal feeding levels commonly used within the aquaculture industry of 40%, and in some circumstances as high as 70%, requires the maximum levels for cadmium in the total diet for fish to be adjusted from 0.4 mg/kg to 1.0 mg/kg. This value aligns with the maximum level set in the EU for fish feeds and recognizes the different feeding practices in aquaculture relative to terrestrial livestock.

Since cadmium is found in feed, particularly in mineral-based feed ingredients, control measures at the feed ingredient level remain critical to reducing contamination in foods of animal origin and therefore reducing human exposure. According to feed monitoring data collected from 1999 to 2017 by the CFIA under the National Feed Inspection Program, the types of feed commonly associated with contamination are copper sulfate, phosphates, and all zinc-based minerals. These findings corroborate those of the European Union (EFSA, 2004a).

Based on the review of the scientific information, the standards set by other national and international jurisdictions, and sample monitoring data, the proposed maximum levels for cadmium in feed are sufficient to mitigate the risk of cadmium toxicity to animal health and human health. Therefore, the proposed maximum level of cadmium in the total diet will be 0.2 mg/kg for horses, 1.0 mg/kg for fish, and 0.4 mg/kg for all other livestock species.

Lead

One respondent commented on the proposed maximum level for lead and was in agreement with the proposed maximum of 8 mg/kg for lead. As such, no changes to the levels proposed are indicated as a result of the consultation.

Fluorine

Based on comments received related to fluorine content of fish feeds, the CFIA reviewed additional relevant information and is proposing a maximum level for fluorine in complete feed for fish of 350 mg/kg. This takes into consideration data provided by respondents associated with fluorine concentrations in marine based feed ingredients commonly used in fish feeds, the CFIA's recent pre-market assessments of krill meal and its manufacturing process along with fluorine concentrations of other marine-based feed ingredients. This proposed maximum level in fish feeds also aligns with the standards set by the EU who also considered the increased fluorine levels in marine crustaceans (example, krill), and new processing/manufacturing techniques to increase the nutritional quality (and reduce the loss of biomass).

Based on the comments received, the proposed revised maximum levels for arsenic, cadmium, lead and fluorine are summarized in Appendix I. These levels will be moved forward into the document to be incorporation by reference. Please note that the maximum levels established are based on total livestock diet.

Additional respondent feedback

Policies in other jurisdictions

2 respondents indicated that the CFIA should align with the EU standards regarding chemical contaminants as they currently have the strictest guidelines of our trading partners. This would further align with the Canada-Europe Trade Agreement (CETA), and many ingredients are based on the European tolerances already.

1 respondent felt the US policy on chemical contaminants should be followed where regulatory action for chemical contaminants in feeds is decided on a case-by-case basis.

CFIA response

The CFIA appreciates the importance of trade and has regular discussions with our international regulatory counterpoints (European Commission, EFSA and US FDA) with regards to standards for contaminants. At this time there are no accepted international standards for biological contaminants in feed. Given that the regulatory systems and authorities in countries differ, it is not always possible to completely align.

The CFIA took into consideration the maximum levels for contaminants in other jurisdictions when setting the biological contaminant maximum levels and has aligned with the jurisdictions to the extent possible. Differences between countries could be impacted by factors such as country-specific weather patterns which would impact the presence or absence of a particular biological contaminant or country-specific animal consumption data which would influence the total diet levels used. How standards are set, for example via guidance versus directly in the regulations, are impacted by the authorities and regulatory approaches that specific countries take. Setting maximum levels using incorporation by reference provides greater clarity to stakeholders with respect to the standards they need to meet, while allowing flexibility to update and change the values as new scientific information becomes available.

Standards for single ingredient feeds

The proposal suggested that maximum chemical contaminant levels would be established in the Regulations for certain livestock feed ingredients or total livestock diets or both.

CFIA response

The CFIA has chosen to set some contaminant standards on an ingredient basis and others on a total diet basis. The factors that were considered included:

  • the risk management objective associated with the contaminant
  • the physical and chemical properties of the contaminant
  • the practicality of sampling and enforcing
  • the ability to analyze for the contaminant in different matrices

Setting different contaminant standards for different species accounts for species differences with respect to their physiological characteristics and sensitivity to, ability to accumulate, and duration of exposure to contaminants.

Setting standards based on single ingredients, classes of ingredients, and/or complete feeds considering species differences is not unique to the approach proposed in Canada as other regulators make use of this approach (e.g. EU Legislation on Undesirable Substances in animal nutrition). Furthermore, the current standards for feeds for example Schedules IV and V and Regulatory Guidance (RG-8) have been implemented in this way for many years so the Canadian feed industry and CFIA inspectors have familiarity with this approach.

Exports

The proposal referenced policy direction provided in the CFIA's 2015 Consolidated Modernized Framework Proposal suggesting that all feeds manufactured in Canada intended for export would need to meet Canadian standards for safety, including maximum chemical contaminant levels, and other domestic compliance requirements. 7 respondents indicated a concern with these proposed controls on feeds destined for export, suggesting that the idea of imposing Canadian domestic standards on feeds for export was unreasonable. These respondents went on to suggest that feeds for export should be subject to the regulations of the importing country or Canadian standards should be imposed only when the importing country specifically requests to adopt the standards.

CFIA response

Given the additional feedback received from stakeholders and greater clarity on the approach that the food program is taking, it is proposed that for feed the CFIA follow the approach for the export of food products as set out in the Safe Food for Canadians Regulations.

Feeds intended for export would be required to be manufactured:

  • by a CFIA licence holder
  • in accordance with a preventive control plan
  • in accordance with documentation demonstrating that the importing country's requirements are being met

If the importing country does not specify its own requirements, Canadian safety standards would apply.

Analytical testing

4 respondents provided feedback with respect to the required analysis to be used in determining maximum chemical contaminant levels in their feeds. Concerns expressed by the respondents included a lack of information in the proposal concerning the reliable analytical methodology to be employed. Furthermore, respondents felt there was a lack of guidance regarding the acceptable testing frequency that must be conducted in order to comply with the Regulations. 1 respondent suggested a table of ingredients normally used in livestock feeds with testing recommendations for contaminants and acceptable limits be provided for reference. 2 respondents also expressed concern over the interpretation challenges that exist in the quantification of dioxin congeners and suggested the establishment of maximum limits for each of the 29 dioxin congeners in the Regulations would be necessary.

CFIA response

The identification of hazards in feed ingredients and the sampling and testing frequency of a feed product should be part of a facility's preventative control plan (PCP). It is the responsibility of the feed manufacturer or supplier to ensure that the feeds they import, export, manufacture, or sell, are safe and meet the maximum levels of chemical and biological contaminants for feed.

Certificates of analysis from accredited labs, labs that are able to demonstrate their method validation or results generated using validated testing procedures or kits, may be incorporated into a PCP. Accreditation bodies such as the Standards Council of Canada can provide insight into the proficiency of labs. The use of validated standard methods, such as those developed or endorsed by bodies like AOAC International, is recommended. Neither the frequency nor method of sampling and testing are prescribed by the Regulations but could be part of a PCP.

Please note that part of CFIA's National Feed Inspection Program consists of sample monitoring programs for biological and chemical contaminants. These sampling programs are used to monitor for background levels of various contaminants in feed and feed ingredients and verify compliance with contaminant standards. The CFIA will provide guidance on best practices for sampling and testing.

Dioxins, Furans and PCBs

There are many labs with Standards Council of Canada accreditation for performing dioxin, furan, and PCB analysis in feeds. The most common analytical methodologies use gas chromatography with high resolution mass spectrometry (GC/HRMS) for the determination of the 7 dioxin congeners,10 furan congeners and 12 dioxin-like PCBs as well as other PCB congeners (example, the six non dioxin-like PCBs). Relevant dioxin, furan, and PCB congeners are listed in Appendix II. Below is a brief description of the methodology used by the CFIA:

Feed samples are thoroughly homogenized. A representative sample is taken, mixed with Ottawa sand and is extracted overnight by soxhlet using ethanol:toluene 7:3. The extract is concentrated, dried, filtered and passed through acidified silica, silica and alumina columns on the PowerPrep system. A carbon column then separates samples into two fractions, dioxin/furans/coplanar-PCB's, and World Health Organization (WHO)-PCB's/marker PCB's. The fractions are concentrated and analyzed by gas chromatography with high resolution mass spectrometry (GC-HRMS) detection (resolution of greater than 10,000). Quantitation is calculated on isotope dilution, and congener (analyte) results are multiplied by toxic equivalent factors (TEF). Results are reported as the upper-bound sum of toxic equivalents (TEQs).

An alternative method, developed by Xenobiotic Detection Systems (XDS), is a bioassay method (XDS-CALUX SW-0846 Test Method# 4435 by the US EPA) for screening dioxins and related dioxin-like chemicals. It has been validated for mineral type feed matrices. The CALUX method is a bioassay and is not a sensitive analytical method that determines and confirms the presence of each dioxin congener, furan congener or dioxin-like PCB congener of interest. This method tends to overestimate the concentrations as a response is seen when any analyte interacts with the Ah receptor. Results of this assay that exceed the maximum TEQ would be considered inconclusive and require additional refined testing.

The European Commission has published regulations and related guidance documents on methods of sampling and analysis for dioxins, furans and PCBs in feed matrices. The following is available on their website : European Commission – Animal Feed

  • Commission Regulation (EU) 2017/771 of 3 May 2017 and related guidance documents
  • guidance Document on the Estimation of LOD and LOQ
  • guidance Document on Measurement Uncertainty for Laboratories performing PCDD/F and PCB Analysis
Metals, Trace Elements, and Minerals

There are a number of validated and standardized methods and accredited labs available for the determination of metals, trace elements and minerals in feed matrices. An example of methods used by the CFIA and a brief description of the sample preparation and instrumentation are below:

The ground sample is digested using a microwave with nitric & hydrochloric acids (3:1). The digestate is transferred quantitatively to a volumetric flask, made to volume with deionized (DI) water, and filtered. Final analysis is done by both inductively coupled plasma optical emission spectrometry (ICP-OES) and inductively coupled plasma mass spectrometry (ICP-MS).

Maximum levels

The proposal indicated that establishing maximum levels for chemical contaminants in the Regulations would allow the CFIA to maintain and enforce regulatory oversight for hazards that may negatively impact human health, animal health or the environment as well as provide stakeholders with clear standards.

CFIA response

Based on the comments received, it appears there are inconsistencies on how "action levels", "guidelines", "maximum limits", and "regulatory maximum limits" are interpreted or used by various stakeholders and between different regulatory agencies. In addition, there seem to be inconsistencies in the interpretation of non-compliance and on the actions to be taken when contaminants are found in feeds above action levels or guidelines versus those prescribed in regulations as maximum limits.

Currently, product control actions are taken when feeds are found to be out of compliance with standards such as:

  • ingredient definitions (example, Schedule IV and V of the Feed Regulations)
  • contaminant action levels (for example, RG-8)
  • regulatory maximums (for example, from Section 19 of the Feeds Regulations)

The risk management goal of product control actions is to bring the feeds into compliance and prevent the entrance or continued entrance of contaminated feeds into the feed chain.

Standards, such as those found in regulations, incorporated by reference documents, or in guidance, should be integrated into industry PCPs and addressed by industry accordingly. If standards are not met, the CFIA would take regulatory action in cases where the industry is not demonstrating that feeds they are responsible for are meeting standards.

The CFIA will better define the terms "action limit" or "maximum level," so all regulated parties and interested stakeholders have a clear and concise understanding of the use of these terms in the context of the CFIA and what they mean (such as, regulatory actions taken if the action limits or maximum limits are exceeded).

The Agency's proposed approach to incorporate a document containing the contaminant maximum levels by reference in the modernized regulatory framework represents an opportunity to take a consistent approach to the setting of such safety standards while providing more flexibility to review and amend the standards on a more timely basis. In keeping with the CFIA's incorporation by reference policy, the CFIA will provide a plan regarding the frequency and process of review and revision of the incorporated document and the maximum limits.

Next steps

The CFIA is preparing a formal regulatory proposal for publication in the Canada Gazette Part I which will take into account the comments received on all the consultation proposals, public meetings, stakeholder workshops and submissions, and other outreach activities that have been used over the course of the project. The CFIA intends to incorporate the chemical, physical and biological contaminant standards into one document titled the Tables of Maximum Contaminant Levels for Livestock Feeds. This draft incorporated by reference document will be available for public review and comment at the time of the Canada Gazette publication.

Appendix I – Maximum contaminant levels in feeds

CFIA response

Note, in the tables below:

"Proposed Maximum Level" refers to a level set out in the August 2017 CFIA Proposal – Maximum Chemical Contaminant Levels in Livestock Feeds
"Revised Maximum Level" refers to the level the CFIA proposes to include in the modernized regulations following consideration of stakeholder feedback received in response to the August 2017 Proposal

Table 1: Dioxins, Furans, and Dioxin-Like PCBs Table Note 1
Livestock Feed Ingredient Proposed Maximum Level Table Note 2
(ng WHO-TEQ2005/kg)
Revised Maximum Level Table Note 2
(ng WHO-TEQ2005/kg)
Fish Meal 2.5 2.5
Fish Oil 12 12

Mineral-based feed ingredients (including natural sources, mined deposits and chemically synthesized products)

For example:

Single Mineral Feed Ingredients (example, Copper Sulphate, Zinc Oxide)

Mineral Complexes; Mineral Chelates; Mineral Proteinates

Trace Mineral Micro-Premixes

1 1.5 Table Note 3

Mineral-based feed ingredients (including natural sources, mined deposits and chemically synthesized products)

For example:
Anti-Caking Agents

1.5 1.5

Vegetable Oils and By-Products of Vegetable Oil Manufacturing

For example:

  • Vegetable (palm) oil
  • Hydrogenated vegetable (palm) oil
  • Calcium salts of fatty acids
  • Fractionated palm fatty acid distillates
  • Hydrogenated palm fatty acid distillates
  • Palm palmitic acid (C16:0)

0.75 (dioxins and furans only)

1.5 (dioxins, furans and dioxin-like PCBs)

0.75 (dioxins and furans only)

1.5 (dioxins, furans and dioxin-like PCBs)

Table Notes

Table Note 1

Referring to 7 dioxin congeners, 10 furan congeners and 12 dioxin-like PCB congeners (Appendix II).

Return to table note 1 referrer

Table note 2

Maximum levels are based on total weight; not moisture or fat corrected values.

Return to table note 2  referrer

Table Note 3

Proposed maximum level was changed to 1.5 ng WHO-TEQ/kg based on analytical method capabilities

Return to table note 3 referrer

Table 2: Total PCBs in Marine Oils
Livestock Feed Ingredient Proposed Maximum Level Table Note 4
(mg/kg)
Revised Maximum Level Table Note 4
(mg/kg)

Marine Oils (oils from approved marine sources listed in Schedule IV)

For example:

  • Fish oil
  • Mollusc oil
0.3 Not proceeding with the proposed maximum level at this time Table Note 5

Table Notes

Table note 4

Maximum levels are based on total weight.

Return to table note 4  referrer

Table Note 5

In the future, CFIA anticipates setting a maximum level for the 6 indicator PCBs as opposed to "total PCBs" in feed ingredients. This approach is consistent with international regulatory agencies.

Return to table note 5 referrer

Table 3: Arsenic in Total Diets Table Note 6 of Livestock
Total Livestock Diet Proposed Maximum Level
(mg/kg)
Revised Maximum Level
(mg/kg)
Total diet for all livestock species 8 8

Table Notes

Table Note 6

Total diet refers to the complete feed for monogastric livestock species and considers complete feed and forage for horses and ruminants.

Return to table note 6 referrer

Table 4: Cadmium in Total Diets Table Note 7 of Livestock
Total Livestock Diet Proposed Maximum Level
(mg/kg)
Revised Maximum Level
(mg/kg)
Total diet for horses 0.2 0.2
Total diet for all other livestock species 0.4 0.4

Table Notes

Table Note 7

Total diet refers to the complete feed for monogastric livestock species and considers complete feed and forage for horses and ruminants.

Return to table note 7 referrer

Table 5: Lead in Total Diets Table Note 8 of Livestock
Total Livestock Diet Proposed Maximum Level
(mg/kg)
Revised Maximum Level
(mg/kg)
Total diet for all livestock species 8 8

Table Notes

Table Note 8

Total diet refers to the complete feed for monogastric livestock species and considers complete feed and forage for horses and ruminants.

Return to table note 8 referrer

Table 6: Fluorine in Livestock Feeds
Feed Type Proposed Maximum Level
(mg/kg)
Revised Maximum Level
(mg/kg)
Mineral feed for Cattle, Sheep or Horses containing 9% or less of Phosphorus 2,000 2,000
Mineral feed for Cattle, Sheep or Horses containing greater than 9% of Phosphorus 3,000 3,000
Mineral feed for Swine 6,000 6,000
Complete feed for Horse and Rabbits 40 40
Complete feed for Cattle and Sheep 50 50
Complete feed for Swine and Turkeys 150 150
Complete feed for Chickens 200 200
Complete feed for fish species 150 350
Complete feed for other livestock species 150 150

Appendix II – The World Health Organization (WHO) 2005 Toxic Equivalency Factors (TEFs) for Dioxins, Furans and Dioxin-like PCBs

Polychlorinated Dibenzo-para-dioxins (PCDDs)
Congener WHO 2005 TEFs
2,3,7,8-TCDD 1
1,2,3,7,8-PeCDD 1
1,2,3,4,7,8-HxCDD 0.1
1,2,3,6,7,8-HxCDD 0.1
1,2,3,7,8,9-HxCDD 0.1
1,2,3,4,6,7,8-HpCDD 0.01
OCDD 0.0003
Polychlorinated Dibenzofurans (PCDFs)
Congener WHO 2005 TEFs
2,3,7,8-TCDF 0.1
1,2,3,7,8-PeCDF 0.03
2,3,4,7,8-PeCDF 0.3
1,2,3,4,7,8-HxCDF 0.1
1,2,3,6,7,8-HxCDF 0.1
1,2,3,7,8,9-HxCDF 0.1
2,3,4,6,7,8-HxCDF 0.1
1,2,3,4,6,7,8-HpCDF 0.01
1,2,3,4,7,8,9-HpCDF 0.01
OCDF 0.0003
Dioxin-Like PCBs (DL-PCBs) – Non-ortho PCBs
Congener WHO 2005 TEFs
PCB 77 0.0001
PCB 81 0.0003
PCB 126 0.1
PCB 169 0.03
Dioxin-Like PCBs (DL-PCBs) – Mono-ortho PCBs
Congener WHO 2005 TEFs
PCB 105 0.00003
PCB 114 0.00003
PCB 118 0.00003
PCB 123 0.00003
PCB 156 0.00003
PCB 157 0.00003
PCB 167 0.00003
PCB 189 0.00003
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