What we heard report: Consultation on proposed guidance on how to determine when a plant-derived ingredient requires a feed pre-market assessment

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Introduction

The Canadian Food Inspection Agency (CFIA) conducted a 60-day consultation on proposed new guidance for How to determine when a plant-derived ingredient requires a feed pre-market assessment, from September 27, 2023 to November 27, 2023. This new guidance clarifies what plant-derived feed ingredients require a pre-market evaluation, as per the Feeds Act and Feeds Regulations, including how to make a novelty determination of ingredients derived through plant breeding destined to be used in livestock feeds. The guidance further describes the characteristics of a plant that could result in a novel feed ingredient.

The purpose of the consultation was to gather comments and feedback on the proposed new guidance. The CFIA received a total of 16 comments from various stakeholders. All comments were carefully analyzed and, where applicable, used to revise and finalize the new guidance. A summary of the comments received during this consultation period is available below.

Background

The CFIA administers a National Feed Program, which includes a pre-market evaluation process for feeds that require approval or registration. The CFIA evaluates and regulates all feed ingredients, including novel feeds, in the same manner. A novel feed is any feed ingredient that is new (that is, not already listed in Schedules IV or V of the Feeds Regulations) or has been modified such that it differs significantly from a conventional ingredient.

For feed ingredients that require pre-market evaluation, which includes novel feeds, approval or registration must be obtained before being manufactured in, sold in, or imported into Canada. The regulations require an application to be submitted and for the CFIA to evaluate the information. The purpose of all feed evaluations is the same: to ensure that the feed ingredient is safe (in terms of animal health, human health via food residues and worker/bystander exposure, and the environment) and effective for its intended purpose. Exposure evaluation is a key component of the safety and efficacy evaluation. The evaluation also ensures that the feed is accurately described in the Feeds Regulations and is labelled appropriately for its safe, effective use and consumer protection. Following an evaluation, an ingredient approval decision is made and communicated to the applicant. The outcomes of an ingredient evaluation are described in the Outcomes of an ingredient assessment.

In the past few years, we have seen great advancements in plant biotechnology. New genetic modification tools have emerged, collectively called gene editing technologies. These advancements enable plant developers to create precise and efficiently targeted genetic modifications in new plant varieties. In response to these advancements, developers have stressed the need for enhanced clarity, predictability, and transparency in the regulatory oversight of plant breeding products. More specifically, the industry has expressed the need for clarification on the regulatory interpretation of novelty as it relates to products developed through gene editing technologies. This need was emphasized in a recommendation in the 2018 Report of Canada's Economic Strategy Tables: Agri-Food and identified as an objective in the Government of Canada's Agri-food and Aquaculture Regulatory Roadmap (2019).

The purpose of the guidance document is to clarify what plant-derived ingredients require a pre-market evaluation, including novelty determinations, under the Feeds Regulations. Regarding novelty determination, the guidance elaborates on and describes the characteristics of a plant-derived ingredient that would result in a novel feed ingredient.

Who we heard from

During the consultation period, the CFIA received a total of 16 sets of comments and feedback.

Stakeholders were comprised of:

  • 10 agricultural associations and organizations (industry associations and non-government organizations)
  • 5 companies, and
  • an individual of the general public

What we heard

Participants responded with great interest and appreciation for the opportunity to provide feedback on the proposed new guidance. Diverse perspectives were received that fell under several general themes.

This report intends to summarize stakeholders' suggestions, comments and feedback. It does not attempt to include every comment received, nor does it imply consensus on the part of all participants. The feedback has been categorized into 5 broad themes.

  • Theme 1: general support for regulatory guidance
  • Theme 2: regulatory oversight and responsibilities, and scope of the guidance
  • Theme 3: transparency, trade implications, and trust in the regulatory system
  • Theme 4: areas of improvement in the novelty criteria
  • Theme 5: other topics

Stakeholder feedback summary

Theme 1: general support for regulatory guidance

The proposed guidance document was generally seen positively by stakeholders. They praised it for providing clarity and predictability regarding when a feed pre-market evaluation is required. Canada's regulatory framework was commended for its flexibility, which is crucial for safety, environmental protection, and innovation. The guidance's alignment with recent Health Canada and CFIA guidance was praised, as was the inclusion of a worksheet tool to simplify the novelty self-determination process. Stakeholders believed the guidance provided a clear, practical, and predictable regulatory framework for adopting new technologies in agriculture. Overall, stakeholders believed the guidance would enhance Canada's international reputation for grain safety and quality, foster competitiveness for Canadian producers, and enhance food security domestically.

Stakeholders provided the following statements in support of the guidance:

  • Canada's flexible, product-based regulatory framework is praised for ensuring safety, environmental protection, and innovation
  • the new guidance is seen as maintaining Canada's international reputation for grain safety and quality
  • the new guidance provides a clear, practical, and predictable regulatory framework for adopting new technologies in agriculture
  • the new guidance supports safe innovations to address domestic crop demand

    this guidance is crucial for transparency
    It helps companies identify pre-market needs and determine the time to market for innovations

  • encouraged by the draft guidance, it is seen as supporting Canada's flexible, product-based regulatory framework that ensures safety while fostering agricultural innovation
  • the proposed guidance aligns with aspects of Health Canada's and the CFIA's Plant Biosafety Office's recent guidance, demonstrating coherence in regulatory approaches
  • stakeholders supported the inclusion of an excellent worksheet tool, which significantly simplifies the novelty self-determination process
  • CFIA's regulatory process provides a consistent and predictable pathway to commercialization, ensuring Canadian producers have access to new technologies for competitiveness
  • the new guidance will foster an environment for Canadian farmers and ranchers to compete globally and enhance food security domestically
  • the proposed updates clarify novel feed pre-market evaluation triggers, levelling the playing field for Canadian breeders while maintaining safety

CFIA's response

The CFIA thanks stakeholders for providing supportive comments for this guidance.

Theme 2: regulatory oversight and responsibilities, and scope of the guidance

Comments were received concerning the regulatory oversight of livestock feeds especially as it relates to plant breeding. Stakeholders provided input on the scope of the guidance, suggesting insights on how to appropriately limit its regulatory reach while ensuring effectiveness. It was recommended that the guidance's scope be limited to determining if plant-derived feed ingredients obtained through new plant breeding techniques are considered novel feed, with a statement clarifying the application of existing regulations for the pre-market evaluation of other plant-derived feed ingredients. In addition, comments were received regarding shifting responsibility for safety to plant breeders, emphasizing the importance of regulations in incentivizing safety and quality.

Stakeholders provided the following feedback:

  • the updated guidance targets plant breeders developing improved crops and covers pre-market evaluation for novel feeds, including determining novelty in plant-derived feed ingredients

    This suggests broader impacts beyond plant breeding. Clearer scope descriptions are needed to prevent confusion

  • the guidance should be limited to determining if ingredients derived through plant breeding for livestock feeds contain a novel trait

    A statement could be included that all other elements of the animal feed regulations for novel feeds continue to apply as they have in the past

  • historically, plant breeders have not been tasked with determining if feed ingredients derived from their improved varieties meet existing feed ingredient descriptions separately from identifying a novel trait

    Novel feed reviews by the CFIA traditionally determine if plant-derived ingredients meet existing ingredient descriptions or if new descriptions are needed

  • if there is no novel trait in the plant, it is unclear how any plant-derived ingredients would fail to meet an existing feed ingredient description from a plant breeding perspective

    Even with a novel trait, all products reviewed to date have been deemed to meet existing descriptions, making the additional requirement redundant for plant breeders

  • efficacy, use rates, and claims have not traditionally been part of novel feed safety reviews
  • separate the claim review process from the novelty evaluation
  • stakeholders do not subscribe to the concept that plant breeders and developers have the unbiased ability to self-determine marketplace risks of new technologies that enter the marketplace
  • caution against placing sole responsibility for food safety, feed safety, and risk evaluations on developers, emphasizing the importance of regulations in incentivizing safety and quality
  • technologies should be introduced responsibly to prevent unforeseen market access/trade issues that could disrupt the marketplace
  • criteria for novelty of seed products should be consistent across agencies in Canada and globally to harmonize regulatory determinations
  • conventional plant breeding falls within the scope of the novel feed guidance in Canada, potentially capturing more products than in other jurisdictions

    Pre-market evaluation should only be required for truly different and potentially unsafe seed products

CFIA's response

This guidance document does not alter the regulations, and the regulatory requirements remain unchanged. Therefore, the scope of the regulatory oversight also remains unchanged regarding what feeds require approval or registration and the evaluation endpoints such as safety and efficacy.

Novel feed is a subset of the legislative definition of feed, making all provisions of the Feeds Act and Feeds Regulations applicable to novel feed where feed is mentioned unless otherwise indicated. The regulatory provisions for efficacy, purpose, and claims equally apply to plant-derived feed ingredients.

Through engagements with various stakeholders, the CFIA recognized the need for all-encompassing guidance for plant-derived ingredients. This document was created to clarify all aspects of a plant-derived ingredient requiring a pre-market evaluation, not solely ingredients with a novel trait.

Both industry and government share responsibility for safe and effective feeds, feed ingredients, and, ultimately, our food. The CFIA uses various tools, including consultation, publication of regulatory guidance, and feed industry notices to inform regulated parties of the requirements. Regulated parties must be aware of the regulatory requirements they must comply with. This guidance does not alter the responsibilities of proponents to be compliant with the Feeds Act and Feeds Regulations.

As specified in the guidance document, the responsibility of seeking approval may not always lie with the variety developer. Still, it could also rest with other proponents, such as grain/ingredient manufacturers or industry associations wishing to sell, manufacture, or import a plant-derived ingredient as a feed in Canada.

While many of the evaluation conclusions to date have found plant-derived feed ingredients to be as safe and nutritious as the conventional ingredient and meet the current ingredient description, some ingredients with a novel trait have required a modification to the existing description or a new description was required following a pre-market evaluation. The CFIA has added text to the guidance that links to the outcomes of an ingredient evaluation.

The CFIA has included additional text to further explain the importance of Schedules IV and V in relation to novelty determination. Key concepts and terms relevant to the novelty determination process have also been elaborated on.

Under the Canadian regulatory framework, Plants with Novel Traits (PNTs), novel foods, and novel feeds are considered novel products under the Seeds Regulations (part V), Feeds Regulations, and the Food and Drug Regulations, respectively. It is important to note that a novel product is not defined in the same manner under these regulations. Health Canada and the CFIA Plant Biosafety Office have released their new guidance to address stakeholders' requests for clarity

Theme 3: transparency, trade implications, and trust in the regulatory system

A recurring theme highlighted during the consultation was the importance of transparency and trust in both the food and feed regulatory systems and government oversight. Stakeholders emphasized the critical importance of transparency and accountability, particularly regarding gene-edited products. They stated that mandatory disclosure and transparency were essential to ensure public understanding and prevent potential risks. Concerns were raised about the potential degradation of trust in the food system and decreased transparency in the supply chain. Stakeholders stressed that transparency was not only crucial for consumer understanding but also for the manufacturing sector to ensure accurate product marketing and material selection. Additionally, there were calls for clarity in regulatory authorizations in key trading jurisdictions to avoid trade barriers, particularly with the United States. Global regulatory transparency, certainty, and consistency were also highlighted as crucial for realizing benefits and avoiding competitive disadvantages. However, stakeholders expressed concerns that current voluntary databases, such as Seeds Canada and the Health Canada Transparency Initiative, might not ensure full disclosure of gene-edited seeds, posing significant business risks to the organic sector.

Stakeholders provided the following feedback:

  • disclosure and transparency of gene-edited food, seed, and feed should be mandatory, not voluntary, to ensure accountability and public understanding
  • transparency in the supply chain is essential for the manufacturing sector to ensure accurate product marketing and the selection of materials meeting business requirements
  • developers should be required to submit information on new gene-edited feed products to competent authorities for publicly available publication to prevent lack of transparency and accountability
  • concerns for trade disruptions regarding organic products
  • global regulatory transparency, certainty, and consistency are crucial for realizing these benefits and avoiding competitive disadvantages

CFIA's response

Transparency regarding the availability of seed varieties in the market is crucial for organic producers to maintain their organic certification and market access. Accordingly, in May 2023, the Chair's Report to the Minister on the Industry-Government Technical Committee on Plant Breeding Innovation Transparency was released. The report outlined several key recommendations to improve transparency around seed varieties. These recommendations include developing an audit framework, enhancing oversight and data in the Canadian Variety Transparency Database, and exploring other options to improve overall awareness and transparency. To address the recommendations outlined in the report, Agriculture and Agri-Food Canada launched the Industry-Government Steering Committee on Plant Breeding Innovation Transparency in June 2023, which is comprised of 11 non-government stakeholders with representation from the organic, horticulture, grains, and seeds sectors. This committee is responsible for overseeing transparency initiatives for gene-edited seeds in the Canadian marketplace. Its primary goal is to safeguard the integrity of all agricultural value chains, particularly Canada's organic certification system. The Steering Committee meets regularly to advance the Chair's recommendations.

Theme 4: areas of improvement in the novelty criteria

The CFIA received specific comments regarding some of the novelty criteria, such as secondary metabolites, claim and use.

Secondary metabolites

Stakeholders highlighted the need for clearer guidance on secondary metabolites in breeding activities, focusing on their impact on livestock feed and animal safety. It was suggested that the guidance should be edited to combine toxins and secondary metabolites to better address known risks. There was a request to either remove secondary metabolites as a separate criterion or establish a clear link to risk before requiring a pre-market evaluation.

Stakeholder comments included:

  • there is a need for clarification to understand changes to secondary metabolites regarding breeding activities, impact on livestock feed nutrition, and animal safety
  • combine toxins and secondary metabolites to focus on known risks to animal health, improving clarity and applicability for plant breeders
  • secondary metabolites linked to animal risk are adequately addressed in other sections of the guidance, making a separate criterion for them redundant

CFIA's response

In response to stakeholder comments, the CFIA updated the text related to secondary metabolites. The CFIA recognizes that many secondary metabolites are considered nutrients, anti-nutrients, or toxins and are therefore captured in other sections of the guidance document. However, for those secondary metabolites not captured elsewhere in the document, the proponent should analyze secondary metabolites with known properties and levels in the plant that are associated with feed safety and could impact the use of the ingredient in livestock feeds. The CFIA has specified that not all secondary metabolites need to be analyzed.

Claims

Stakeholders highlighted confusion over the guidance's inclusion of claims as a trigger for novelty in plant-derived ingredients, suggesting that a claim review process should be separate from the novelty evaluation.

Stakeholder comments included:

  • a claim on a feed should not be a trigger for novelty; a claim review process should be separated from the novelty evaluation
  • the guidance's inclusion of claims as a trigger for novelty is not understood, especially from a plant breeding perspective

    It may be misinterpreted to mean that even if there is no novel trait, if a claim is desired, the product will be deemed novel and subject to a plant risk evaluation, including extensive plant characterization. This evaluation is different from what is needed to substantiate a claim, creating confusion about the criteria for determining novelty in plant-derived ingredients

CFIA's response

In response to stakeholder concerns, the CFIA clarified that the guidance document does not alter existing regulations and that regulatory requirements remain unchanged. This regulatory guidance document captures instances when a plant-derived ingredient requires a pre-market evaluation, including when a claim is made regarding a feed. It should be noted that novel feed falls within the legislative definition of feed, subjecting it to the entirety of the Feeds Act and Feeds Regulations unless otherwise indicated. This includes regulatory provisions for claims, which also apply to plant-derived feed ingredients.

Use

Stakeholders emphasized the need for clarity on when changes in use rates of nutrients/macronutrients require a pre-market evaluation, noting that such changes are typically not under the control of plant breeders. They also suggested that if plant modifications do not intend to alter use rates affecting animal nutrition requirements and do not meet other criteria for a novel trait, a pre-market evaluation may not be necessary.

Stakeholder comments included:

  • changes in the use rate of nutrients/macronutrients have not traditionally required a pre-market evaluation, have not been observed to impact animal nutrition requirements, and are not under the control of the plant breeder
  • for plant breeders, if the breeding objective is not specifically intended to or known to alter use rates in a way that would impact animal nutrition requirements, and none of the other criteria for determining a novel trait are met, it can reasonably be assumed the plant modification would not impact use rates in a way that would require a pre-market evaluation.
  • It should be clarified that a pre-market evaluation should be required only when a plant modification requires a change in use rate to avoid a safety issue (for example, exceeding established maximum nutrient values or elements known to have risk)
  • additional clarity can be provided around use rates to ensure that any change in use rate requiring a pre-market evaluation is truly novel
  • use rates are determined by the feed formulation, which the manufacturer sets, not the plant breeder. Nutrient levels can vary between plant varieties developed through conventional breeding and require formulation adjustments
  • feed use rates are not determined by plant breeders and are not necessarily linked with novelty as Plant breeders could misinterpret the proposed consultation verbiage to imply that any feed ingredient will require a novelty review if rates to feed may change as an outcome

CFIA's response

The CFIA expanded on text related to important concepts related to novelty determination, explained key terms such as use and purpose, and provided more information on ingredient descriptions and how these relate to the requirement for pre-market evaluation. As "use" is a key term within the novel trait definition, the novelty determination must consider the impact of a modification on the use of the plant-derived ingredient. Plant breeders might not intentionally aim to alter the use of the ingredient in their breeding objectives; however, a new characteristic in the plant could inadvertently change its use or safety, including how the animal's nutritional requirements are considered.

The concept of use encompasses the ingredient's purpose in the livestock animal or the feed, the intended species or class of livestock, and the usage rate of the ingredient in the diet formulation. Note that the term "use rate" was replaced with "usage rate" to add clarity and differentiate it from the general term "use". The expanded explanation in the guidance document helps clarify how usage rate is connected to use and, therefore, to the novel trait definition. In addition, the concept of usage rate was further elaborated on.

Nutrient levels/bioavailability

Stakeholders emphasized aligning pre-market evaluation requirements with recent changes in Feed Regulations, removing minimum nutrient values to reduce regulatory burden while maintaining animal safety. They also sought clarification to ensure safety levels of anti-nutrients are maintained.

Stakeholder comments included:

  • it was stated that the requirement for pre-market evaluation should align with recent changes to the Feed Regulations, where minimum nutrient values were removed

    This change recognizes the feed industry's expertise in ensuring nutritional requirements for livestock species are met, reducing regulatory burden without impacting animal safety.

  • some nutrients/macronutrients do not have minimum or maximum levels required to meet the feed ingredient description in Schedules IV and V

    Instead, there is a requirement to label a guarantee for a minimum (for example, protein and fibre). This acknowledges that plant composition can vary between varieties and years, whether naturally or through conventional breeding, leading to the need for more or less of a specific commodity in the feed product to meet the feed manufacturer's specifications.

CFIA's response

The guidance document aligns with the upcoming changes in the proposed Feeds Regulations, 2024, regarding the minimum nutrient values being removed as a requirement for pre-market evaluation. In situations where modification may result in increased levels of nutrients that do not have the maximum nutrient values indicated, plant developers should evaluate whether the increase will affect the usage rate of the ingredient in livestock diets. The CFIA also updated the guidance document to describe how required guarantees are set for ingredient descriptions and that plant breeders must consider the composition of the plant-derived ingredient beyond just the guarantees required per the ingredient description. In addition, the CFIA expanded on how changes in nutrient levels and bioavailability may impact foods of origin and how these impacts should be considered in the novelty determination process.

Theme 5: other topics

Miscellaneous feedback on various topics beyond the defined themes was also received during the consultation.

Stakeholders emphasized the need for clarity on gene-editing safety and alignment with Health Canada. They sought further details on novel trait criteria, labelling requirements for gene-edited crops, and the regulatory process for multiple gene-edited stacks.

Stakeholder comments included:

  • comments emphasized the need for a statement in the feed guidance confirming that gene editing technologies pose no unique safety concerns compared to other breeding methods and aligning with guidance from Health Canada and the CFIA Plant Biosafety Office
  • further clarity is needed on how authorizations will be reviewed when multiple gene-edited breeding stacks are involved and how they will sync with other regulatory jurisdictions
  • it is unclear if there will be any labelling requirements for livestock feed manufacturers for feed derived from gene-edited crops, beyond existing labelling requirements

CFIA's response

In response to stakeholder comments, the CFIA added a statement in the feed guidance confirming that gene editing technologies pose no unique safety concerns compared to other breeding methods. The CFIA would like to clarify that the regulatory alignment on gene-edited stacks and labelling requirements regarding methods of production fall outside the scope of this consultation. Where possible, the CFIA's feed regulatory guidance aligned with that of Health Canada and the CFIA's Plant Biosafety Office.

Next steps

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

Based on the comments and feedback received from this consultation, amendments were made to the guidance on how to determine when a plant-derived ingredient requires a feed pre-market evaluation. The updated guidance will be published on the Novel feeds page on the CFIA website.

Related information

Contact us

Animal Feed Program (AFP)
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario K1A 0Y9
Email: cfia.afp-paa.acia@inspection.gc.ca

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