Consultation summary: Proposed guidance for Novel Food Regulations focused on plant breeding

What we heard report

2022

Table of contents

• Executive summary

• Background

• What is the new guidance?

• Consultation details

• Summary of what we heard

• Highlights

• General themes

  • Theme 1: Clarity and predictability

  • Theme 2: Government oversight

  • Theme 3: Safety of products of plant breeding

  • Theme 4: Transparency

  • Theme 5: Other topics

• Annex A: List of consultation participants

Executive summary

Protecting the health of Canadians and the Canadian food supply is, and always will be, Health Canada’s top priority. Health Canada has a mandate to assess the safety of all products defined as ‘novel foods’ prior to their food use in Canada as per the Novel Food Regulations. Since the enactment of these regulations (1999), technological advancements have created new tools of genetic modification by which new plant varieties can be developed (e.g., gene editing technologies). Consequently, developers expressed the need for the Novel Food Regulations to be clearer, more predictable, and more transparent regarding products of plant breeding, including those developed using these new tools.

In August 2020, Health Canada published a Notice of Intent to develop new guidance for the Novel Food Regulations, focused on products of plant breeding. The intent of the proposed new guidance is to improve the clarity and predictability in the oversight of novel foods, which was highlighted as 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).  

To this end, Health Canada conducted a 60-day public consultation (March 25 - May 24, 2021) on two proposed pieces of new guidance (i.e., Health Canada Guidance on the Novelty Interpretation of Products of Plant Breeding and Health Canada Guidance on the Pre-Market Assessment of Foods Derived from Retransformants). The guidance aimed to clearly identify what products of plant breeding are considered ‘novel foods’ and require pre-market notification and assessment, while also finding opportunities to make the pre-market assessment and the decision-making processes related to novel foods more predictable and transparent.

This report summarizes the feedback received through the consultation conducted in the Spring of 2021. Feedback was received and grouped under the following five key themes:

Theme 1: Clarity and predictability

Theme 2: Government oversight

Theme 3: Safety of products of plant breeding

Theme 4: Transparency

Theme 5: Other topics related to other dimensions of biotechnology

Throughout the consultation, Health Canada received over 4600 comments from interested participants. These comments reflect a wide range of perspectives and a number of common themes were identified and highlighted in this report. All comments were carefully reviewed, considered, and where relevant, used to revise and finalize the new guidance.

This report aims to reflect the summary of the suggestions, comments and feedback received through the consultation. The views expressed are those of the participants in the consultation process and not representative of Health Canada or the Government of Canada.

Background

Canada’s Novel Food Regulations (Division 28, Part B, of the Food and Drug Regulations, or FDRs) were published in 1999. Under these regulations, a developer is required to file a pre-market notification with Health Canada and for the Department to determine that the information in that notification establishes that the food is safe before it can be sold.

To aid in the interpretation of these Novel Food Regulations, Health Canada published the Guidelines for the Safety Assessment of Novel Foods. These guidelines describe how regulators conduct novel food pre-market safety assessments and the information that must be contained in a notification. This guidance document was last updated in 2006.

Since that time, technological advancements have created new tools of genetic modification by which new plant varieties can be developed. These tools include gene editing technologies.

In light of these new tools, developers highlighted the need for clearer, more predictable, and more transparent regulation of products of plant breeding, including those developed using gene editing technologies.

In August 2020, Health Canada announced its intent to develop and publish new guidance for novel foods to provide better clarity and predictability in how the Novel Food Regulations are applied to products of plant breeding. The need for greater clarity and predictability regarding Canada’s novelty-based regulatory framework was highlighted as 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). This new guidance takes account of the health and safety objectives of the regulations, making use of the regulator’s experience as this field of science has evolved since the regulations were published. The proposed new guidance seeks to interpret the Novel Food Regulations in a manner that takes account of the current scientific knowledge and the underlying scheme and purpose of these rules (i.e., to require pre-market assessment of novel foods that may pose a potential risk to the consumer) in a way that reflects the importance of innovation, a greater understanding of plant breeding practices, and the benefits of aligning with our international regulatory partners.

Furthermore, Health Canada developed proposed new guidance for the pre-market assessment of products of plant breeding that closely resemble products that have previously been assessed by the Department. This proposed new guidance seeks to tailor the assessment process with the level of risk of these products.

Health Canada sought input from stakeholders on these proposed new pieces of guidance by conducting a 60-day public consultation in the Spring of 2021 (March 25 - May 24, 2021).

What is the new guidance?

The first piece of proposed new guidance (referred to as the ‘novelty interpretation’ guidance) describes the specific criteria by which a food derived from a product of plant breeding would (or would not) be considered by Health Canada to meet the definition of a ‘novel food’ as defined under the Novel Food Regulations. This guidance describes each of these criteria in detail such that a developer will be able to self-determine whether or not their product is novel (i.e., require pre-market notification). This guidance also described a Voluntary Transparency Initiative (VTI) which will be launched to support the implementation of the new guidance. The VTI process aims to increase transparency and raise public awareness of products derived from gene-edited plants which do not meet the definition of novel foods, but may be present in the Canadian food supply. Through the VTI process, developers will voluntarily submit information about their products to Health Canada for publication on the Department’s website. 

The second piece of proposed new guidance (referred to as the ‘retransformants[1]’ guidance) describes a tiered pre-market assessment process for products of plant breeding that are considered ‘novel foods’; however these products closely resemble products that have previously been assessed by Health Canada. The guidance describes in detail what information is required for the pre-market assessment of these products (defined as ‘retransformants’) as well as an expedited service standard for Health Canada to render a decision based on this assessment.

Both pieces of the proposed new guidance have been added to and supplement the existing 2006 Guidelines for the Safety Assessment of Novel Foods. Additionally, a new webpage for the VTI process (now referred to as the Transparency Initiative [TI] process) has been published. This new guidance represents the first phase of a broader, multi-year effort to modernize the Novel Food Regulations.

Consultation details

Health Canada held a public consultation from March 25 to May 24, 2021 on the proposed new guidance for the Novel Food Regulations, focused on plant breeding. This consultation provided an opportunity for Health Canada to collect feedback on the proposed new guidance from a variety of groups, including regulated parties, interested stakeholders, and the general public. During the consultation period, Health Canada received over 4600 comments. Participants were comprised of 67 associations and organizations (provincial governments, industry associations, non-government organizations, and academia), as well as individuals of the general public. Once received, the comments were carefully analyzed and reviewed by Health Canada.  

This consultation allowed Health Canada to collect information, suggestions, and diverse perspectives from stakeholders with a keen interest in, and knowledge of the current novel foods regulatory framework.

Summary of what we heard

Highlights

Throughout the consultation, participants responded with great interest and appreciation for the opportunity to provide feedback on the proposed new guidance. Diverse perspectives were received and fell under a number of general themes. Certain feedback included suggested revisions to the guidance.

Below is the combined feedback from the 60-day public consultation. This report intends to summarize the suggestions, comments and feedback that were provided by stakeholders. It does not attempt to include every comment received, nor does it imply consensus on the part of all participants. It presents a summary of what we heard from input that was wide-ranging. The views expressed are those of the participants in the consultation process and not representative of Health Canada or the Government of Canada.

General themes

The Department has grouped what we heard from stakeholders under five key themes:

Theme 1: Clarity and predictability

A number of participants provided general feedback expressing views on whether the proposed new guidance introduces greater clarity and predictability regarding what products of plant breeding are subject to pre-market notification under the Novel Food Regulations. Some participants indicated that the guidance was not clear regarding the regulation of specific plant products (e.g., gene-edited plants, international products versus domestic products). More specifically, participant comments focused on ensuring that the technical concepts and definitions within the guidance are well-articulated to avoid any possible misinterpretation of when pre-market notification is required. Furthermore, participants expressed the need for clearer indication of when scientific data and/or rationale is required for both the pre-market assessment of ‘retransformants’ and products submitted under the Voluntary Transparency Initiative (VTI).

• The proposed new guidance will provide better clarity to plant breeders/developers when determining the novelty of products with certain characteristics produced through conventional methods of plant breeding and gene editing technologies.

• The proposed new guidance will generate more innovative plant varieties for farmers to select from and opportunities to diversify genetics at the farm level. Plant breeders/developers will gain a better understanding of whether their products will require a pre-market assessment and approval as a novel food in Canada.

• More regulatory certainty will reduce costs and time requirements regarding the development of new plant varieties, removing an important barrier to innovation.

• The clarity provided in the proposed new guidance will be helpful for the ongoing use of conventional methods of plant breeding and the potential use of new tools like gene editing technologies in the future. It is important that breeders have access to all available options because conventional breeding can be labor-intensive and time-consuming compared to newer tools like gene editing technologies.

• The greater clarity and predictability provided by this guidance will encourage additional research and more public and small- to medium- company participation in plant breeding where barriers related to plant novelty determination and approval of genetically modified varieties are difficult to overcome.

• Greater clarity that the novel food regulations apply to both international and Canadian food products would be beneficial.

• Greater clarity is required on why foods made with gene editing (e.g., CRISPR) are not regulated.

Theme 2: Government oversight

The issue of the proposed new guidance and its effect on government oversight towards food products of biotechnology, including GM foods, was a recurring theme in the feedback received.

• The guidance will improve the current system and provide better alignment with the concept of regulatory approaches that are tied to specific risks, if any, associated with a food crop.

• The new guidance gives developers the authority to decide what is novel and not novel. Government regulators should determine product safety, not developers.

• No additional oversight of products of plant breeding is required unless there is a unique risk not covered by other regulations.

• All GM products (including gene-edited products) should be regulated and require a safety assessment prior to marketing.

• The proposed new guidance retains the product based approach of the Novel Food Regulations.

• Any decrease in government oversight is a risk to the safety of the food supply. Health Canada’s proposed new guidance abdicates its responsibility and threatens food safety and democracy.

Theme 3: Safety of products of plant breeding

Stakeholders recognize the importance of product safety for the integrity of Canada’s food supply and the comments related to this theme mainly fall into two categories; Food safety risks from new technologies is unknown and products of plant breeding are low or no risk to Canadians.

• Plant breeders have a longstanding safety record. Plant breeders have well-established screening and quality management processes to look for and evaluate food safety risks. This work is already required by other existing regulatory requirements.

• Gene editing tools will improve the ability of Canadians to access nutritious food, at affordable prices, thereby improving food security in Canada and abroad.

• The safety of food derived from genetically modified organisms is unknown. Consuming foods from genetically modified organisms destroy/harm healthy gut bacteria and can have unforeseen long-term consequences.

• Canadians and the Canadian environment will be test subjects/experiments for these new technologies.

• The specific impact of off-target edits, as well as unintentional on-target edits, is unknown and could negatively impact food safety. Therefore, all products of genome editing should undergo pre-market safety assessment before commercialization.

• Off-target genome edits are not unique to genome editing tools and are similar to mutations that occur in conventional breeding.

• Absence of long-term studies involving products of gene-editing makes it impossible to demonstrate gene-edited product safety.

• As our scientific understanding is constantly growing, because something was approved in the past shouldn’t mean that it never has to be evaluated again in the future.  New food safety risks might be revealed with our growing understanding. 

Theme 4: Transparency

Stakeholders recognized the importance of the public’s interest in plant breeding and demonstrated support for a more transparent, more predictable, and clearer regulation of these products. Overall, stakeholders expressed mixed opinions for the proposed new guidance pertaining to transparency and how the proposed Voluntary Transparency Initiative (VTI) would affect public trust.

• The proposed new guidance is based on the best available scientific evidence and uses a risk proportionate approach.

• Health Canada will maintain its reputation as a science-based and product-based trusted regulator.

• Allowing developers to self-determine the novelty status of their products is a conflict of interest.

• Unregulated gene-edited products will enter the organic sector and erode the ability of vegans to follow their beliefs, causing distrust in the Canadian food supply.

• It should be made clearer that the VTI is a true notification process that does not require submission of data, but rather contains information limited to what the public may find relevant.

• The VTI must be mandatory and necessitates submission of data that describe the gene-edited product.

• The VTI could be confused with a formal pre-market safety assessment outcome.

• A voluntary initiative will increase the risk that some companies will not submit information, hence resulting in the List of non-novel products of plant breeding for food use may not contain all the unregulated GM crops.

• If Health Canada does not verify the commercial status of notified products, companies may use the VTI as a promotional tool to attract investors on theoretical genome-edited products that may never be commercialized. This will confuse the public.

Theme 5: Other topics

Through the consultation, Health Canada received a number of comments that were considered to fall outside of the scope of the proposed new guidance. It is important to highlight that, while outside the scope of the guidance, a significant number of comments expressed a desire for the mandatory labelling of GM foods.

In addition, relevant comments related to the proposed new guidance’s effect on economics and/or trade considerations were provided to the relevant departments for consideration.

• Health Canada should conduct mandatory, independent safety assessments for all genetically engineered foods and release the scientific evidence used to demonstrate product safety. Furthermore, the federal government should create an independent, arm’s length scientific risk assessment authority in order to provide scientific guidance on regulatory decision-making. Private companies cannot be trusted to properly test for safety.

• Health Canada’s Meetings and Correspondence on the development of new regulatory guidance for novel foods shows a disturbing pattern based on significant access by industry stakeholders at all levels of the department prior to the opening of the consultation.

• The cost of analysis and costs of producing regulatory data are major factors in the decisions on whether to develop new crop lines with improved characteristics.

• There should be mandatory labelling of all GM Foods.

• The use of gene editing will allow scientists to expedite crop development in response to rapid environmental changes and help feed the world with a lesser impact on our environment.

• The proposed new guidance will hurt small farms who will not have access to the information they need to make informed choices about the seed they purchase and crops they grow. The Government should encourage local small farms; they have good soil and take care of their plants.

• The proposed new guidance will help small farms, create jobs, and farmers will now have more seed to select from for their breeding programs.

• The use of GMOs (including gene-edited plants) will lead to increased use of pesticides and are associated with the use of glyphosate. General concern over the use of pesticides was also expressed.

• The proposed changes risk damaging the integrity of Canada’s organic food and seed sector.

• Comments related to international trade and alignment including:
• The proposed new guidance for novel food regulations issued by Health Canada lays out rules that would put us closer to the United States (US) than the European Union (EU) model;
• The proposed new guidance will better align Canada with the rest of the world;
• The proposed new guidance supports Canadian breeder competition with international breeders;
• Concerns that this may result in trading partners rejecting shipments.

• Comments related to Canada’s competitiveness in the agricultural sector including:
• The new guidance is needed to secure Canada’s long-term competitiveness, product innovation, and job creation;
• The proposed new guidance significantly improves Canada’s ability to increase developer efforts to attract private investors;
• Delays in or unavailability of modern biotechnology practices leads to the risk of lost opportunity for our growers;
• The proposed new guidance will help grow our agricultural exports and speed the post-COVID economic recovery.

• Access to a variety of products developed using genetic engineering tools should be restricted.

• A tax should be placed on any food product (for human or for animal consumption) that is genetically modified or that includes ingredients that are genetically modified.

• The proposed new guidance erodes and undermines public trust in the safety of the Canadian food system and risks Canada’s international reputation.

• General concerns regarding the safety of COVID-19 vaccines, the use of the precautionary principle regarding the regulation of GM foods, the decline of pollinators (e.g., bees) due to the use of pesticides, and to the safety of specific GM products (rice/corn (GM and non GM)/flax, salmon, Arctic apples).

• Concerns related to previous risk management related to other industries (e.g., tobacco, automobiles, commercial fishing), to high-sugar and other highly-processed products, to new methods of food production (e.g., lab grown meats), and to the use of bovine growth hormones.

Annex A: List of consultation participants

Feedback was received from the following organizations and from individual Canadian citizens:

Agricultural Producers Association of Saskatchewan

Agriculture & Food Systems Institute

Agri-Food Innovation Council

Alberta Canola

American Seed Trade Association

Amis de l’environnement de Brandon

BASF Canada

Bayer Crop Science

Bioenterprise

BIOTECanada

Canada Grains Council

Canada Organic Trade Association

Canadian Canola Growers Association

Canadian Federation of Agriculture

Canadian Health Food Association

Canadian Hemp Trade Alliance

Canadian Horticultural Council

Canadian Producer Marketing Association

Canadian Seed Growers' Association

Canadian Sugar Beet Producers

Canola Council of Canada

Canadian Biotechnology Action Network

Cereals Canada

Cibus Canada ULC

Corteva

CropLife

CropLife International

Flax Council of Canada

Forage Genetics International

Friends of the Earth Canada

Genome Canada

Government of Saskatchewan

Grain Farmers of Ontario

Grain Growers of Canada

Hjelle Advisors

International Seed Federation

J.R. Simplot Company

KWS Seeds

Manitoba Canola Growers

National Council of Women of Canada

National Farmers Union

Norcan Seeds

North American Export Grain Association

Ontario Fruit & Vegetable Growers Association

Ontario Ministry of Agriculture, Food and Rural Affairs

Pairwise

Protein industries Canada

Pulse Canada

Rob Potter Consulting

Safe Food Matters Inc.

Sask Wheat

Saskatchewan Flax Development Commission

SaskCanola

SaskOrganics

SeedChange

Syngenta

Seeds Canada

Sollio

Soybean Canada

Syndicat des producteurs de grains biologiques du Québec

The Bauta Family Initiative on Canadian Seed Security

The Canadian Council of Churches

Union des producteurs agricoles

United Farmers of Alberta Co-operative Ltd

Vegan Society of Canada

Vigilance OGM

Western Canadian Wheat Growers Association

[1] Within this guidance, a ‘retransformant’ is defined as a novel food derived from a genetically modified (GM) plant that has been transformed with the identical DNA sequence as a previously assessed GM plant, where the introduced genetic changes result in the same mechanism(s) of action and characteristic(s) as the previously assessed GM plant.