Questions and Answers: Revisions to Directive 94-08 – Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits

What is a plant with novel trait (PNT)?

Under Canadian regulations, a plant is considered to be a plant with novel trait (PNT) if it has a trait that is new to the plant species and has the potential to have an effect on the environment or people.

What is Directive 94-08?

Before a PNT can be released into the environment, it must be authorized for unconfined environmental release. Directive 94-08 provides applicants with guidance on the process, application requirements, and the environmental safety assessment for an unconfined environmental release authorization.

What has changed in Directive 94-08?

The updated Directive 94-08 includes both administrative changes and two additional revisions of:

• stewardship plans for plants with novel disease resistance traits
• modernized information requirements for similar plants with novel traits

Why does the revised directive look so different?

Directive 94-08 was first drafted in 1994 and has since been updated to on an ad-hoc basis. During current revisions, the CFIA reviewed the entire directive and made administrative changes to increase clarity and continuity and to reduce redundancy.

When will the changes take effect?

All changes will take effect in June 2018.

Stewardship plans for plants with novel disease resistance traits

What are stewardship plans?

Stewardship plans are submitted as part of the environmental safety application for plants with the following novel traits:

• insect resistance
• herbicide tolerance
• disease resistance (new)

Stewardship plans include appropriate strategies that will allow for environmentally safe and sustainable deployment of the PNT. The CFIA considers these stewardship plans in its evaluation of a PNT's potential long-term environmental effects.

Why is the CFIA asking for stewardship plans for disease resistant traits?

The CFIA already asks for stewardship plans for plants with novel insect resistance traits and herbicide tolerance traits as part of its environmental safety assessment. Because plants with novel disease-resistance traits have similar environmental safety and sustainable deployment considerations, the CFIA is extending its request for stewardship plans to these plants.

Is requiring stewardship plans for plants with novel disease resistance traits consistent with other jurisdictions?

Yes. The United States Environmental Protection Agency's Biopesticides and Pollution Prevention Division (EPA-BPPD) also requests stewardship plans for plants with disease resistance traits.

Modernized information requirements for similar PNTs

Why is the CFIA modernizing its environmental safety assessment of PNTs?

The CFIA has completed over 100 assessments of PNTs since the mid-1990s. Through these assessments, the CFIA has repeatedly evaluated certain plant species and traits, and has consistently found they are safe for the environment. With that knowledge, this policy update will allow future PNTs submissions to refer to previously authorized PNTs with similar traits. The new PNTs submission will still need to be fully assessed.

By modernizing its information requirements for similar PNTs based on previous risk assessments, the CFIA can focus on products that have an unknown potential to pose environmental risk. As a result, the CFIA will more efficiently and effectively fulfill its mandate to safeguard the food supply and plant resource base.

Does this policy update make it easier to authorize PNTs?

The CFIA is maintaining the strict safety requirements for PNTs and is not making it easier for new PNTs to be authorized. This policy update does not represent an easing of the PNT requirement‒every new PNT submission will still need to be fully assessed through the environmental safety assessment. This is a thorough process with many steps depending of the complexity of the file.

What is an environmental safety assessment for a PNT? What information is taken into consideration in this assessment?

The environmental safety assessment for a PNT considers the potential risk posed by the PNT to the environment. This is evaluated by comparing the PNT to a suitable comparable plant, typically a non-modified plant of the same species.

The assessment considers:

• the plant's potential to become a weed or to invade natural habitats
• the potential consequences of gene flow to related species
• the potential for the plant to become a plant pest
• the potential impact on non-target organisms, including humans
• the potential impact on biodiversity

A PNT will only be authorized for environmental release if its environmental impact is deemed to be less than or equivalent to a suitable comparable plant.

Once a PNT has been authorized for environmental release and has obtained all other appropriate regulatory approvals, it is considered to be as safe as any other plant of the same species.

What does a modernized environmental safety assessment look like?

CFIA evaluators examine the scientific information submitted by applicants who are hoping to have their product authorized. There are strict requirements describing safety assessment criteria and how CFIA evaluators must examine this information.

The same strict requirements and criteria for safety will continue to apply for new PNTs that are similar to PNTs that have been previously authorized by the CFIA. Data gathered during previous PNT assessments will form the basis for the review of PNTs with similar traits. The applicant must show the CFIA how their product is similar to one or more previously authorized PNTs through a detailed and comprehensive product comparison.

After reviewing the product comparison, if the CFIA agrees that the product is similar, then the CFIA will use previous authorization decisions to address certain information requirements (such as research field trial data) since the environmental risks were already considered in these assessments.

How does the CFIA define a similar PNT?

For PNTs to be considered similar, the CFIA must have previously authorized the environmental release of one or more PNTs that meet all of the following criteria:

1. Familiarity with the plant species: The CFIA has authorized the environmental release of one or more PNTs from the same plant species;
2. Familiarity with the novel trait category: The CFIA has authorized the environmental release of one or more PNTs with the same broad novel trait category (for example, insect resistance, herbicide tolerance) in the same plant species.
3. Familiarity with the mechanism of action: The CFIA has authorized the environmental release of one or more PNTs with the same functionally equivalent mechanism of action.

More than one previously authorized PNT can be used to establish similarity. For example, a PNT can be considered similar if it is of the same species and has the same broad novel trait category as a previously authorized PNT (criteria 1 and 2), and if novel trait is conferred by the same mechanism as in a previously authorized PNT of any species (criteria 3).

What are examples of PNTs that could be considered similar?

An example of a PNT that could be considered similar to a previously authorized PNT is a soybean (Glycine max) that is tolerant to the herbicide glyphosate as a result of the soybean's expression of a glyphosate-insensitive form of the enzyme 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS). This soybean is considered similar because the CFIA has authorized the environmental release of one or more similar PNTs:

1. from the same plant species (soybean);
2. from the same broad novel trait category in the same plant species (herbicide tolerance in soybean); and,
3. that uses the same functionally equivalent mechanism of action to introduce the novel trait(s) in a plant species (glyphosate tolerance conferred through expression of a glyphosate-insensitive EPSPS).

Will similar PNTs be assessed and authorized faster?

Although it is expected that the time to assess the environmental safety of similar plants with novel traits (PNTs) will be reduced, the decision to authorize any PNT is still subject to a "no-split approval" policy between the CFIA and Health Canada. This means that the final authorization of a product cannot be granted until all assessments for environmental release (CFIA), animal feed safety (CFIA), and human food safety (Health Canada) have been completed.

Is the approach for similar PNTs consistent with other jurisdictions?

Yes, the approach for similar PNTs is consistent with the extension process used the United States Department of Agriculture's Animal and Plant Health Inspection Service - Biotechnology Regulatory Services (USDA-APHIS-BRS).