Straight Drive or Dog Leg Left? What is the Least Intrusive & Most Effective Way to Regulate Turfgrass Plants with Novel Traits?

This discussion document was developed by the Plant Biosafety Office of the Canadian Food Inspection Agency

November 2006

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Table of Contents

• 1.0 Executive Summary
• 2.0 Introduction
• 3.0 Novelty
  • 3.1 Novelty in the Context of Plants with Novel Traits
  • 3.2 Novelty in the Context of Plants with Novel Traits
• 4.0 Current Regulatory Requirements for PNTs
  • 4.1 Permits to Import
  • 4.2 Confined Field Trials
  • 4.3 Unconfined Release Assessments
  • 4.4 Other Requirements for Unconfined Release
• 5.0 Challenges in implementing consistent PNT regulation in agriculture, horticulture, forestry, and other sectors
  • 5.1 Challenges concerning novelty as the regulatory trigger
  • 5.1.1 Challenges in determining 'newness'
  • 5.1.2 Challenges in determining potential to impact environmental safety
  • 5.2 Challenges concerning the availability of biological information
  • 5.3 Challenges posed by standards for containment
• 6.0 Conclusion

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1.0 Executive Summary

In March 2004, the Office of the Auditor General of Canada released a report on the Canadian Food Inspection Agency's (CFIA's) Regulation of Plants with Novel Traits. In this report, the Office of the Auditor General recommended that the CFIA raise awareness about the regulations for ornamental plants with novel traits (PNTs) and to engage the ornamental industry in developing a pragmatic way forward in this respect. The workshops scheduled for February 17-18, 2005 and February 20-21, 2006 were the beginning of a series of activities to which the CFIA has committed in order to follow up with the recommendations made by the Office of the Auditor General.

A PNT is a plant that contains a trait(s) that has been intentionally introduced that is both new to the Canadian environment and has the potential for environmental impact. PNTs can be produced through a wide range of techniques including conventional breeding, mutagenesis, somaclonal variation, and rDNA technology, etc.

Environmental releases of PNTs are subject to the Seeds Regulations, Part V under the Seeds Act. The CFIA provides regulatory oversight to ensure that such plants do not pose a greater threat to the environment than other plants of the same species currently cultivated in Canada.

The CFIA recognizes that the turfgrass industry is unique and that innovation can be an important factor in remaining competitive. However, the CFIA also has the responsibility to implement regulations consistently for all PNTs. The question is: Can we regulate environmental releases of turfgrass PNTs the way we have for other PNTs (Straight Drive) or do we need to adapt the current system to better accommodate the uniqueness of the turfgrass industry (Dog Leg Left)? In this respect, the CFIA is committed to work with all relevant stakeholders in order to develop a pragmatic path forward in regulating all PNTs.

2.0 Introduction

The Government of Canada has been overseeing environmental releases of Plants with Novel Traits (PNTs) since 1988, primarily of agricultural field crops. Currently, this regulatory oversight is administered by the Plant Biosafety Office (PBO) of the Canadian Food Inspection Agency (CFIA). In March 2004, the Office of the Auditor General of Canada released a report on the Regulation of Plants with Novel Traits¹ through the Canadian Food Inspection Agency. The report recommended that the CFIA raise awareness among plant breeders and importers of ornamental plants about the regulations for PNTs. The report also recommended that the CFIA analyze and address inconsistencies with respect to implementing regulations for PNTs within Canada. How the CFIA regulates ornamental PNTs was an area of concern for the Office of the Auditor General.

The CFIA is committed to addressing the recommendations of the Auditor General and the PBO has already held two workshops to address these concerns (Workshop on Ornamental Plants with Novel Traits, held in Ottawa, ON on Feb. 17-18, 2005 and Fruit Trees and Ornamental Trees with Novel Traits Workshop, held in Kelowna, BC on Feb. 20-21, 2006). One of the conclusions of these workshops is that the regulatory process we use for agricultural field crops will be difficult to implement as-is for use in the ornamental industry. For example, because the ornamental industry deals with relatively small volumes of multiple kinds of species that are used in agriculture, the determination of novelty can be more complex for ornamental species than for agricultural species. Also, recovery of investment in meeting regulatory requirements can be more challenging in ornamental species that in agricultural species. By engaging the Canadian turfgrass industry, the current workshop is a continuation of the PBO's consultations with stakeholders outside of traditional agriculture that are impacted by the Seeds Regulations, Part V. Once the input of the ornamental, fruit tree, ornamental tree, turfgrass, and forest tree industries has been analyzed, the PBO will propose and seek comment on any modifications to current regulation of environmental releases of PNTs that might address the needs of these sectors (see Figure 1).

Figure 1: Proposed consultative approach for determining the least intrusive, most effective process for regulating environmental releases of all Plants with Novel Traits (PNTs). Step 1 includes information gathering sessions with stakeholders of various industries. Steps 2 and 3 are an iterative process that includes an analysis of the gathered information followed by presentation of findings/recommendations to relevant stakeholders until a consensus has been met. Step 4 will culminate with a final design and implementation of a process for effectively regulating environmental releases of all PNTs.

The purpose of this discussion document is to (i) provide guidance on what constitutes a plant with a novel trait, (ii) outline the current regulatory requirements for PNTs in Canada, and (iii) initiate discussions on how to regulate environmental releases of turfgrass PNTs consistent with regulation of other PNTs.

The workshop scheduled for November 20-21, 2006 will provide participants with the opportunity to openly discuss current regulatory requirements for PNTs in Canada. The workshop will also provide a venue for participants to exchange opinions, comments, and questions on identified areas that require discussion. Proceedings from the workshop will be recorded and made available to all participants and the general public. The objectives of the workshop are:

1. For the PBO to understand the key relevant issues regarding the environmental release of PNTs facing the Canadian turfgrass industry;
2. For turfgrass importers and breeders to understand how the Canadian PNT regulatory system might apply to their work;
3. To identify the aspects of the PBO's regulatory process that work for the turfgrass industry, as well as the challenges that the regulatory process poses;
4. For the PBO to collect suggestions from turfgrass breeders and importers to use in adapting the PNT regulatory process to the turfgrass industry.

3.0 Novelty

The word 'novelty' may be used in many different ways. In the ornamental plant industry, novelty may imply that a plant is unique enough to catch the eye of landscapers and home gardeners or provide a new function. In the Plant Breeder's Rights Act, 'new' is one of the criteria that a plant variety must meet in order to qualify for Plant Breeder's Rights. Under the Food and Drugs Act and Regulations, specific criteria are described that determine which products trigger a safety assessment as a novel food. Plant species that are completely new to the Canadian environment are deemed as novel species. The Plant Health Division of the CFIA is responsible for pest risk assessments of novel plant species in Canada. This discussion document will deal with the criteria that define a plant with a novel trait, and the regulation of its environmental release, as provided under the Seeds Act and Regulations.

3.1 Novelty in the Context of Plants with Novel Traits

The novelty of a trait is used as a trigger for regulatory oversight under the Seeds Act and Regulations. If a plant expresses a novel trait, a safety assessment on the plant is required to ensure that the plant does not pose a risk to the environment, human and/or animal health and safety. To date, agricultural crops such as canola, corn and soybeans have been the focus of public attention due to concerns regarding environmental, human and animal health and safety. However, it is the role of the CFIA to ensure that all plants with novel traits do not pose a risk to the environment.

Directive 94-08 "Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits" was prepared to provide guidance regarding the submission of an application for the authorization of the unconfined environmental release of a plant with a novel trait. The Seeds Regulations, Part V of the Seeds Act defines a "novel trait" in respect of seed, means a characteristic of the seed that:

1. has been intentionally selected, created or introduced into a distinct, stable population of cultivated seed of the same species through a specific genetic change, and
2. based on valid scientific rationale, is not substantially equivalent, in terms of its specific use and safety both for the environment and for human health, to any characteristic of a distinct, stable population of cultivated seed of the same species in Canada, having regard to weediness potential, gene flow, plant pest potential, impact on non-target organisms and impact on biodiversity.

In essence, a PNT is a plant¹ that contains a trait(s) that has been intentionally introduced that is both new to the Canadian environment, irrespective of the method of trait(s) introduction, and has the potential to change the specific use and safety of the plant with respect to the environment and human health.

Although regulation in Canada is broader than those frameworks administered in other countries, a level and scientifically consistent playing field is maintained for Canadian developers and importers of new plant varieties. For example, plant breeders have developed three different novel herbicide tolerant canola varieties using 1) traditional breeding, 2) mutagenesis and 3) recombinant DNA/transgenic breeding techniques. The different breeding techniques have respectively produced an atrazine tolerant, imidazolinone tolerant, and a glyphosate tolerant canola variety. All of the novel varieties pose the same potential risk to the environment i.e. risk of increased weediness and issues regarding control of herbicide tolerant volunteers. Canada has a product-based regulatory system to ensure that all of these varieties trigger regulatory oversight and an assessment of risk is required prior to their release into the environment. Under a process-based regulatory framework, only the glyphosate tolerant canola would trigger regulations in the above example.

1 Note that a PNT is a plant of a species that already exists in the Canadian environment. A plant of a species that is new to the Canadian environment is a novel species, not a PNT, and its importation is subject to the Plant Protection Act.

3.2 Deciding what is a PNT and what is just a new plant

Directive 94-08 indicates that the responsibility for determining if a plant is considered a PNT rests with the importer, plant breeder or developer. The requirement for notifying the PBO, CFIA and being granted authorization to release the PNT into the environment is triggered by the presence of a novel trait in the plant. The PBO, CFIA will assist any developer, importer or plant breeder in a determination of novelty and has recently updated its Directive 94-08 that provides guidance in determining if a plant expresses a novel trait. Current initiatives are underway to further refine the use of "novelty" as a trigger for regulatory oversight.

The determination of novelty is made on a case by case basis depending on the plant species and the new trait that is present. According to the Seeds Regulations, Part V, a novel trait is one that is both new to that species in Canada and has the potential to impact the environmental safety of the plant. A determination of novelty can require a significant familiarity with a plant species and the new trait. The PBO, CFIA is currently drafting a guidance document to assist plant breeders, developers and importers in determining if a plant has a novel trait. This document will discuss considerations in determining if a trait is 'new' to the species in Canada. The document will also discuss categories of traits and consider the likelihood that each of them may raise an environmental safety concern.

4.0 Current Regulatory Requirements for PNTs

The PBO, CFIA regulates environmental releases of all PNTs under the Seeds Act and Seeds Regulations, Part V. The CFIA also regulates the importation of PNTs under the Plant Protection Act.

For plants that meet the definition of a novel food or a novel feed as per the Food and Drugs Act and Regulations and the Feeds Act and Regulations respectively, the Government of Canada requires that food safety and animal feed safety assessments are carried out by Health Canada and the CFIA, respectively, prior to being granted approval for unconfined release into the environment. However, PNTs that are not intended for food or feed use may not be required to undergo food safety and animal feed safety assessments. Please note that food and feed safety evaluations will not be a focus of this workshop. For more information regarding the legislative responsibility for the regulation of biotechnology see Appendix 1.

The responsibility for determining if a plant is considered a PNT rests with the importer, plant breeder or developer (the applicant). Once the plant breeder or importer determines that the plant expresses a novel trait there are three areas where there may be additional regulatory requirements, specifically related to: 1) imports (see section 4.1); 2) requirements for confined field trials in some cases (see section 4.2); 3) requirement for assessment and authorization prior to unconfined release (see section 4.3).

4.1 Permits to Import

The Plant Protection Act regulates the importation of plants into Canada in order to prevent the importation/exportation and spread of pests injurious to plants within Canada. All imports of unapproved PNTs are required to have a Permit to Import, issued by the Plant Health Division, CFIA, in order to enter Canada, regardless of regulatory decisions by other authorities outside of Canada. Conditions are placed on the import of unapproved PNTs and these are outlined in the Permit to Import. To date, all imported unapproved PNTs are required to enter into containment facilities as they are considered to be a potential plant pest. The release of the PNT into the Canadian environment is subject to the Seeds Regulations, Part V under the Seeds Act and would require authorization from the PBO, CFIA for confined or unconfined environmental release.

For example, an importer that wants to import an unapproved sumac tree (that has some weedy characteristics) that expresses a novel trait (e.g. salt tolerant) into Canada, must obtain a Permit to Import from the CFIA. The Permit to Import will be granted with conditions (such as under the condition that the novel sumac tree enters into a contained facility). Before the novel sumac tree can be released into the environment for commercial purposes an environmental safety assessment and authorization for unconfined environmental release would be required as defined by the Seeds Act and Regulations.

4.2 Confined Field Trials

After a pre-submission consultation with PBO, CFIA, the applicant may discover that they need more data in order to seek authorization for an unconfined environmental release. The applicant can conduct a confined research field trial under the oversight of the PBO, CFIA to gather more scientific data on how the PNT behaves in the Canadian environment to meet the requirements for an unconfined environmental release described in Section 4.4. A confined field trial is one way (but not the only way) of generating the additional information.

A researcher may also seek authorization for a confined field trial for academic research not related to development of a commercial product.

Any applicant wishing to grow a PNT for research purposes outside of containment (see section 5.4 for information on containment) must submit an application to the PBO, CFIA for the release of the PNT into the environment under confined conditions. Confined field trials are used to allow importers and breeders to gather information on the interactions of the PNT with the environment while minimizing the PNT's environmental exposure.

Confined field trials are regulated under the authority of the Seeds Act and the Seeds Regulations, Part V. Confined field trials have associated terms and conditions which are specific to the crop-kind and the nature of the novel trait. These terms and conditions can include, but are not limited to, limiting the size of the trial, reproductive isolation from related species, restricting the use of harvested material, and restricting what types of crops can be produced in that location in subsequent growing seasons. The CFIA inspects all trials to ensure compliance with the terms and conditions.

An applicant must seek approval from the PBO, CFIA prior to planting a confined field trial. Additional guidance on seeking approval for and conducting confined field trials of PNTs can be found in Directive 2000-07: Conducting Confined Research Field Trials of Plants with Novel Traits.

4.3 Unconfined Release Assessments

PBO's unconfined environmental release assessments are carried out under the authority of the Seeds Act and Seeds Regulations, Part V. Additional guidance can be found in Directive 94-08: Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits.

The CFIA undertakes a scientific environmental safety assessment based on comparison with an unmodified counterpart. Information on potential changes in weediness/invasiveness, gene flow, plant pest properties, impacts on other organisms, and impact on biodiversity is gathered by the applicant during confined field trials. This information helps risk assessors determine what (if any) potential risk the PNT poses to the environment and whether the PNT is substantially equivalent to its counterpart. However, the applicant may be able to demonstrate to the PBO, CFIA (using valid scientific rationale) that the PNT is as safe for the environment as its unmodified counterpart, with respect to potential changes in weediness/invasiveness, gene flow, plant pest properties, impacts on other organisms and impact on biodiversity, without undertaking confined research field trials.

If the scientific risk assessment demonstrates that the PNT should pose no greater risk to the Canadian environment compared with its counterpart currently cultivated in Canada, the PNT will be authorized for unconfined environmental release.

In some cases, depending on the nature of the PNT, the PBO, CFIA may authorize the PNT for unconfined release subject to specific conditions (e.g. geographical restrictions). Please see the information on management plans in Section 4.4 for an example. In some cases, the PNT may pose unacceptable risk to the Canadian environment. In this case, the PBO would refuse to authorize the environmental release of the PNT.

To date, the CFIA has authorized PNTs for unconfined release into the environment from the following species: alfalfa, canola, corn, cotton, flax, lentils, potatoes, rice, soybeans, squash, sugar beet, sunflower, and wheat (please note that not all authorized species are currently cultivated in Canada).

4.4 Other Requirements for Unconfined Release

The PBO, CFIA may apply conditions with an authorization for an unconfined environmental release. For example, some PNTs (notably, PNTs with insect resistance or herbicide tolerance) require a management plan as a condition for unconfined release. The applicant must provide an acceptable plan to manage potential development of resistance among insect populations or of herbicide tolerance among weed populations, as part of the submission for unconfined release. Management plans should include appropriate strategies that will allow for the environmentally safe and sustainable deployment of such novel plants. Communication to growers and an efficient mechanism allowing growers to report problems to the applicant are integral parts of a management plan.

All submissions for environmental release must be accompanied by a biology document of the species of plant being submitted. Biology is defined as the science of life and of living organisms, including their structure, function, growth, origin, evolution, and distribution. Developing biology documents for plants may be quite challenging if there is a lack of information on the biology of the plant species and its interaction with the environment. Biology documents have been developed for plants, such as alfalfa, canola, corn, flax, lentils, potato, soybean, sugar beet, sunflower, and wheat, and are publicly available on the CFIA website.

A requirement for all PNTs after authorization for unconfined environmental release is that any new information regarding the environmental safety of that PNT, including the risk to human health, that may come to light after authorization, must be reported to the PBO, CFIA immediately. The PBO, CFIA will re-evaluate the potential effect on, and risk to, the environment and may maintain, change, or remove existing conditions of the release; impose additional conditions; or cancel the authorization.

5.0 Challenges in implementing consistent PNT regulation in agriculture, horticulture, forestry, and other sectors

The CFIA:

• Recognizes that the exposure, intended use, breeding objectives and biology for ornamental plants, ornamental trees, fruit trees, agroforestry trees, and turfgrass, can be different than for agricultural field crops;
• Understands that innovation in the turfgrass industry is an important factor in remaining competitive and is dependant on developing new plants;
• Recognizes that industry and government have to work together to develop a sustainable and workable framework for regulating environmental releases of all PNTs, to ensure environmental safety without unduly hindering innovation.

The Government of Canada has a strong regulatory framework for agricultural PNTs. To date, the Government of Canada has authorized the environmental release of 61 agricultural PNTs. Experience and knowledge of these agricultural plant species has lead to the development of an effective and efficient regulatory system for importers and developers of these products.

In contrast, the Plant Biosafety Office has less experience in regulating the import and environmental release of other PNTs in Canada. Chapter Four (4) of the March 2004 report from Office of the Auditor General recommended that:

1. The CFIA should more formally and more systematically identify the environmental safety issues related to the environmental release of ornamental PNTs.
2. Based on the environmental safety issues, the CFIA should develop appropriate approaches for its assessment and regulation of environmental releases of ornamental plant species with novel traits.

As such, the CFIA is committed to identifying potential environmental risks and subsequently developing consistent risk management procedures for the environmental release of all PNTs, including ornamental, fruit tree, ornamental tree, turfgrass, and forest tree PNTs. Recognizing that it is the mandate of the CFIA to protect the environment from the potential risks of PNTs, invasive plants and plant pests, the CFIA needs to develop a pragmatic regulatory framework for all PNTs that is consistent with existing regulations for all plants. The CFIA is committed to working with key stakeholders to minimize the cost and regulatory burden these regulations may impose.

Consistent, effective regulation of all plants with novel traits is the goal of the PBO, CFIA. However, the PBO, CFIA realizes that Canada's regulatory process can raise significant challenges for some plant breeders and importers. These challenges are not unique to specific industries, but the solution to a challenge may need to be tailored to be effective for a particular industry.

5.1 Challenges concerning novelty as the regulatory trigger

Most plant breeding programs are focused on developing a new plant variety. The existence of Plant Breeders' Rights (PBR) in Canada and the Canadian Ornamental Plant Foundation (COPF) encourage innovation in this respect. These novel plant varieties may be PNTs and thus trigger regulations under the Plant Protection Act or the Seeds Act. The existing challenge for the PBO, CFIA is to provide guidance to importers and plant breeders on how to determine if the plant is a plant with a novel trait as defined in the Seeds Regulations, Part V. The challenge for breeders and importers is to actually determine if the plants express a novel trait. The PBO, CFIA is currently drafting a guidance document to assist importers, breeders and developers in determining if a trait is new to the species and has the potential to impact environmental safety, the two components to the Seeds Regulations, Part V definition of a novel trait.

5.1.1 Challenges in determining 'newness'

Under Part V of the Seeds Regulations of the Seeds Act, seed that has been grown in Canada outside of containment in a stable, cultivated population before 1996 is exempt from the requirement for notification. Essentially, if the trait existed in a plant species that was grown in the Canadian environment prior to 1996, that trait in that species is exempt from Part V of the Seeds Regulations. However, there is no comprehensive source of information available for breeders or importers to determine whether a particular trait existed in a particular species prior to 1996. The PBO, CFIA acknowledges that determining the newness of a trait may be challenging for certain industries such as the turfgrass sector. We hope to explore options to address these challenges at this workshop.

5.1.2 Challenges in determining potential to impact environmental safety

The definition of whether a trait is novel depends not only on its newness but also its potential to impact environmental safety. The components of environmental safety listed in the Seeds Regulations, Part V are: weediness/invasiveness potential, gene flow, plant pest potential, impact on non-target organisms, and impact on biodiversity. The PBO, CFIA acknowledges that determining potential for impact on environmental safety may be challenging for certain industries such as the turfgrass sector. The CFIA is currently drafting a new document to provide guidance on the Seeds Regulations, Part V definition of a novel trait as interpreted and implemented by the Plant Biosafety Office. Items within the document will highlight sections that will discuss the likelihood that various traits may affect the environmental safety of the plant.

5.2 Challenges concerning the availability of biological information

The CFIA has a science-based mandate, and its regulatory oversight is based on sound scientific information. There is a substantial amount of scientific information available for some plant species, and very little available for others. PBO's unconfined environmental release is based on the concept of substantial equivalence to a stable, cultivated counterpart which requires detailed information on interactions with other species, gene flow to wild relatives, etc. The lack of information about some species may pose challenges for both importers and breeders and for the PBO, CFIA in determining novelty and in demonstrating environmental safety.

Working together to compile existing baseline data on plant species would aid both developers and plant breeders in determining if the plant expresses a trait which is either not present in an existing stable cultivated population or has the potential to affect the environmental safety.

Similarly, the PBO, CFIA can explore ways of assisting applicants to develop a biology document describing the environmental interactions of the unmodified species, a requirement for unconfined environmental release.

While each of the environmental safety criteria listed in Directive 94-08 must be addressed in seeking authorization for an unconfined release, it is important to remember that any of these criteria can be addressed by valid scientific rationale rather than actual data. For example, if a grass species submitted for unconfined release contained a trait for increased root proliferation, a rationale can be made that the increased rooting does not change the amount of pollen produced, compared to the unmodified counterpart, and therefore does not need to include pollen dispersal studies.

5.3 Challenges posed by standards for containment

Part V of the Seeds Regulations states that seed which is grown in containment in such a manner that there is no release into the environment of any genetic material from the plants derived from the seed is exempt from the regulations. This exemption is intended to apply to plant material used in biologically secure laboratory facilities such as laboratories or secure greenhouses. There are, however, currently no CFIA guidelines for standards for PNT containment available to researchers (although other guidelines for containment exist, such as Health Canada's Laboratory Safety Guidelines).

6.0 Conclusion

The CFIA has the mandate to ensure that all PNTs do not pose a threat to the environment. The PBO, CFIA has been efficiently regulating environmental releases of agricultural field crops since 1998. However, the current regulatory framework for PNTs, may pose specific challenges for non-agricultural PNTs, including turfgrass plants.

The workshop in Guelph on November 20-21, 2006 will allow the PBO, CFIA to gain further information about the turfgrass industry and will provide stakeholders with relevant information on the current regulations for PNTs. This workshop is one of a series of workshops that will determine an effective manner for the regulation of all PNTs. The CFIA is committed to working with all relevant stakeholders to develop a pragmatic regulatory path forward.

Appendix 1: Legislative Responsibility for the Regulation of Biotechnology

Act	Regulations	Products Regulated	Department(s) or Agencies
Food and Drugs Act	Novel Foods Regulation Food and Drugs Regulations Natural Health Products Regulations Cosmetics Regulations Medical Devices Regulations	Foods, including novel foods, drugs (human and veterinary), human biologics, natural health products, cosmetics, and medical devices	Health Canada (HC)
Pest Control Products Act	Pest Control Products Regulations	Pest control products	Pest Management Regulatory Agency/ HC
Fertilizers Act	Fertilizers Regulations	Fertilizer supplements, including novel supplements (microbial and chemical)	Canadian Food Inspection Agency (CFIA)
Feeds Act	Feeds Regulations	Feeds, including novel feeds	CFIA
Health of Animals Act	Health of Animals Regulations	Veterinary Biologics	CFIA
Seeds Act	Seeds Regulations	Plants, including plants with novel traits	CFIA
Canadian Environmental Protection Act, 1999	New Substances Notification Regulations	All animate products of biotechnology for uses not covered under other federal legislation listed in Schedule 4 of the Act(the legislative/ regulatory "safety net")	Environment Canada/HC