Canada - Proposed new guidance pieces for the Novel Foods Regulation, focused on plant breeding

Introduction

This provides a summary of the two new guidance pieces for the Novel Foods Regulation (Division 28, Part B, of the Food and Drug Regulations), focused on plant breeding. These new guidance pieces will introduce new elements to the existing 2006 Guidelines for the Safety Assessment of Novel foods, including:

• Guidance on foods derived from products of plant breeding

• Guidance on the pre-market assessment of food products derived from retransformants of previously assessed genetically-modified (GM) plants

These new guidance pieces will maintain the health and safety of Canada's food supply, and:

• maintain the product-based system

• align with international approaches (to the extent possible)

• better facilitate a risk-based approach where oversight is commensurate to the level of risk posed by the product

• provide clarity and predictability in the regulatory interpretation of novel products of plant breeding

• support innovation and the introduction of new technologies which result in the production of safe food

These new guidance pieces, focused on plant breeding, represent the first step in a broader, multi-year effort to modernize Health Canada's Novel Foods regulation guidance. The publication of these two new pieces of guidance is intended to fulfill Health Canada's commitment, as stated in the Agri-food and Aquaculture Regulatory Roadmap, to provide greater clarity around the regulatory triggers for novel foods as they relate to plant breeding innovations (PBI).

We intend to:

• add these pieces to the existing 2006 Guidelines for the Safety Assessment of Novel Foods as appendices

• revisit the overall organization of these pieces as we update other parts of the 2006 Guidelines in the coming years

Guidance on foods derived from products of plant breeding

This guidance:

• provides greater clarity and predictability to plant developers by highlighting which foods from products of plant breeding do not require pre-market notification as Novel Foods

• outlines plant developer responsibilities relating to the full characterization of a new plant variety, regardless of what methods were used in its development and selection

For over a century, plant developers have used a large array of breeding methods to produce thousands of plant varieties. Many of these breeding methods have been safely used in the Canadian food supply. Under the product-based regulatory system for Novel Foods, we may consider certain foods derived from products of plant breeding Novel based on the particular characteristics they exhibit.

Over the past 20 years, we have assessed over 140 foods derived from products of plant breeding as Novel Foods. We have found all of them safe for human consumption. We used scientific knowledge and our experience as regulators to develop the new guidance.

Health Canada regulators assessed how best to regulate foods derived from plants developed using gene editing technologies within the pre-market framework of the Novel Foods Regulation. We developed a primer on gene editing technologies that informs our position on how we treat foods derived from gene-edited plants under the product-based system for Novel Foods and within the context of the new guidance. This primer is included in the Guidance on foods derived from products of plant breeding.

Voluntary transparency initiative for non-novel gene-edited plant varieties

There is great interest from and benefit for regulators, industry, and the public in greater transparency regarding what products present in the Canadian food supply were developed using gene editing technology.

Health Canada launched a transparency initiative with the listing of non-novel food and food ingredient determinations made since 2012. We propose to expand this voluntary transparency initiative to non-novel gene-edited plants in response to this interest. Details about this initiative are included in the Guidance on foods derived from products of plant breeding.

Gene editing technologies for the product-based regulatory framework for Novel Foods

We conducted a literature review (referred to as a ‘primer’ in the guidance piece) of the current scientific knowledge about gene editing technologies and how plant developers are using these technologies in plant breeding. This primer supports our position on how we regulate gene-edited plant products under the Novel Foods Regulation.

Guidance on the pre-market assessment of food products derived from retransformants of previously assessed GM plants

This guidance applies to previously assessed retransformant plants. These are plants that exhibit a characteristic that is identical to a characteristic from a genetically modified (GM) plant of the same species that:

• was considered novel by Health Canada

• had previously undergone more than one pre-market safety assessment

The guidance describes:

• specific criteria by which a plant developer can demonstrate that their new plant is identical to a GM plant variety previously assessed by Health Canada

• a pre-market safety assessment process with an expedited service standard for these identical plants with regulatory oversight that is:

• predictable

• commensurate to the level of risk these products pose to Canadian consumers

We have gained extensive experience and familiarity with specific characteristics found in GM plants, such as tolerance to specific herbicides. We have assessed these specific characteristics multiple times. Each time, we have determined that they do not pose a food safety concern.

This knowledge about certain characteristics that we have previously assessed allows us to rank the information requirements for novel foods derived from these GM plants in a way that corresponds with their level of risk.

The consultation document outlines tier 1 and 2 products, including:

• a description of each tier

• the information that plant developers are required to provide

• the criteria to be eligible for a pre-market safety assessment with an expedited service standard, that is, 120 calendar days

Please consult Health Canada's guidance for a complete description of how to make a Novel Food submission.