REPORT OF THE WORKSHOP ON:
TURFGRASS PLANTS WITH NOVEL TRAITS

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

November 21-22, 2006
Guelph, Ontario

This document is meant to reflect the information exchanged at the Turfgrass Plants with Novel Traits Workshop. The concerns, challenges and recommendations presented here reflect the opinions expressed by participants and do not necessarily prescribe a course of action to be taken by the Government of Canada in this subject matter. The concerns, challenges and recommendations will be considered by the Canadian Food Inspection Agency's Plant Biosafety Office in examining our regulatory system.

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Table of Contents

• 1.0 Introduction
• 2.0 Workshop Context

  Presentation:

  • Finding the Balance for the Least Intrusive and Most Effective Regulation of Turfgrass Plants with Novel Traits
    Kirsten Finstad, Acting National Manager, Plant
    Biosafety Office, CFIA
• 3.0 Regulatory Context and Industry Overview

  Presentation:

  • Regulatory Oversight of Environmental Releases of PNTs
    Eric Wierenga, Policy Development Officer, Plant Biosafety Office, CFIA
  • Turfgrass - Industry Overview and Future
    Martin Pick, Pickseed
  • Progress in Breeding for Important Traits in Cool-season Turfgrasses
    Stacy Bonos, Assistant Professor,
    Turfgrass Breeding, Rutgers University,
    Department of Plant Biology and Pathology
• 4.0 Novelty as a Regulatory Trigger

  Presentation:

  • Plants with Novel Traits - Novelty as a Regulatory Trigger
    Kirsten Finstad, Acting National Manager,
    Plant Biosafety Office, CFIA

  Stakeholder Discussion and Feedback

• 5.0 Scientific and Regulatory Challenges

  Presentation:

  • Development of Turfgrass Enhanced by Biotechnology
    Bob Harriman, Scotts

  Stakeholder Discussion and Feedback

• 6.0 Regulation of Environmental Release of PNTs

  Presentation:

  • Overview of the Regulation of Imports of PNTs
    Hong Chen, Environmental Release Assessment Officer,
    Plant Biosafety Office, CFIA
  • Confined Field Trials
    Eric Wierenga, Policy Development Officer,
    Plant Biosafety Office, CFIA
  • Eric Wierenga, Policy Development Officer,
    Plant Biosafety Office, CFIA
  • Unconfined Environmental Release Assessments of Plants with Novel Traits
    Phil Macdonald, Acting National Manager,
    Biotechnology Environmental Release Assessment Unit (CFIA)
  • Stakeholder Discussion and Feedback
• 7.0 Improving Communication and Coordination
• 8.0 Closing Comments
  • Kirsten Finstad, Acting National Manager,
    Plant Biosafety Office, CFIA
• Appendix
• List of Participants

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1.0 INTRODUCTION

On November 20 and 21, 2006, the Plant Biosafety Office (PBO) of the Canadian Food Inspection Agency (CFIA) hosted a workshop in Guelph, Ontario, on Turfgrass Plants with Novel Traits. Participants at the workshop included growers, breeders, and researchers of turfgrasses, representatives of stakeholder organizations, government departments and university research institutes.

The objectives of the workshop were to provide an opportunity for stakeholders and CFIA regulators to exchange information so that:

• the CFIA's PBO could gain a better understanding of the relevant issues facing the turfgrass industry regarding the environmental release of plants with novel traits (PNTs); and
• for turfgrass importers and breeders to gain better understanding of how the Canadian regulatory system for PNTs might apply to their industry.

In addition, the workshop sought to collectively identify the aspects of PBO's regulatory process that are or could be effective for the turfgrass industry, aspects that present difficulties and challenges, and suggestions for adapting the PNT regulatory process to the turfgrass industry.

The workshop was organized as part of CFIA's ongoing response to the recommendations made by the office of the Auditor General in the March 2004 report on the Regulation of Plants with Novel Traits. The audit focused on the processes that the CFIA has in place to ensure that it was meeting its environmental responsibilities with respect to the regulation of plants with novel traits. Recommendations arising from the audit included:

• that the CFIA raise awareness among plant breeders and importers of ornamental plants about the regulations for PNTs; and
• that the CFIA analyze and address inconsistencies with respect to implementing regulations for PNTs within Canada.

The comments and suggestions raised at the workshop will be used by PBO as it moves forward in its review of the regulatory framework for plants with novel traits for all agriculture sectors, including the turfgrass industry.

2.0 WORKSHOP CONTEXT

Presentation

Finding the Balance for the Least Intrusive and Most Effective Regulation of Turfgrass Plants with Novel Traits

Kirsten Finstad, Acting National Manager, Plant Biosafety Office, CFIA

The Canadian Food Inspection Agency's (CFIA) Plant Biosafety Office (PBO) has been regulating environmental release of plants with novel traits (PNTs) since 1988, with most experience relating to agricultural field crops. In response to recommendations of the Auditor General for improvements to how CFIA regulates ornamental PNTs, PBO held stakeholder workshops in Ottawa (Workshop on Ornamental Plants with Novel Traits, February 2005) and Kelowna, B.C. (Workshop on Fruit Trees and Ornamental Trees with Novel Traits, February 2006). Discussions at those workshops indicated that the regulatory process in use for agricultural field crops would be challenging to apply "as-is" to non-agricultural PNTs.

PBO's goal is to develop and implement an effective and efficient regulatory system for all PNTs. However, there are specific challenges related to each industry that need to be addressed.

The current workshop on environmental release of turfgrass plants with novel traits is being held to gather information and gain a better understanding of the specific challenges of this industry. Analysis of this information, along with information already gained from the Ottawa and Kelowna workshops and subsequent stakeholder input, will be used to determine the best way to adapt the regulatory framework for plants with novel traits that is in use for agricultural field crops so that it also effectively encompasses other sectors, such as ornamentals, agroforestry trees, and turfgrasses.

3.0 REGULATORY CONTEXT AND INDUSTRY OVERVIEW

Presentations

Regulatory Oversight of Environmental Releases of PNTs

Eric Wierenga, Policy Development Officer, Plant Biosafety Office, CFIA

The regulatory system for PNTs is science-based and delivered on a case-by-case basis. The trigger is "product" based, rather than "process" based. A PNT could be developed through either traditional (e.g., mutagenesis, conventional breeding) or modern (e.g., genetic engineering) techniques.

Currently, PNTs are, by definition, of a species currently grown in Canada. The PNT regulations being discussed at this workshop do not address species that are new to Canada (novel species). PBO is working with the Invasive Alien Species Section of the CFIA and other regulatory stakeholders to develop ways to effectively regulate novel plant species.

Plants with Novel Traits are defined as a plant containing a trait:

• Not present in plants of the same species already existing as stable, cultivated populations in Canada; or
• Potential to have a safety concern for the environment and for human health.

Novel does not always equal risk.

If a plant is considered a PNT, an assessment on the plant is required to ensure that the plant does not pose a risk to the environment, human or animal health or safety. The PBO assesses potential impact on the environment, such as increased weediness/ invasiveness, gene flow and its consequences, altered plant pest potential, adverse effects on non-target organisms, and adverse effects on biodiversity.

Until the assessment is complete, the PNT in question must be restricted to contained use (i.e. research lab or greenhouse) or confined field trials. Contained use usually applies to PNTs intended for research, imported PNTs that may have or be pests, plants in the early stages of PNT breeding programs, and high-risk PNTs. For confined field trials, terms and conditions are both general and species-specific and include requirements for reproductive isolation, post-harvest land use restrictions, field trial site monitoring, field size restrictions and disposal of plant material. However, as the regulatory approach is case-by-case, a determination of novelty does not necessarily mean a PNT has to go through confined field trials.

Once the proponent has enough information on the potential environmental impacts of the PNT, they may submit to the PBO field trial data and valid scientific rationale that the PNT does not pose a risk. The PBO then conducts an environmental safety assessment, using five main criteria:

• What is the potential for the plant (or its offspring) to become a weed or to be invasive?
• What is the potential for gene flow to wild relative plants?
• What is the potential to become plant pest or to impact existing plant pest?
• What is the potential impact on non-target organisms?
• What is the potential impact on biodiversity?

If no significant environmental risk is identified, an unconfined environmental release is authorized. Once a PNT is approved, proponents are obligated to notify CFIA should any new information arise. In addition, depending on the PNT it may be necessary to register the variety (Variety Registration), undergo a Pest Management Regulatory Agency review, or develop stewardship plans. Once approved for unconfined release, a PNT variety is treated like any other variety with respect to importation and sale of seed.

The system promotes regulatory transparency and openness through the publication of decision documents and stakeholder consultations. It provides harmonized approvals between Canadian regulators (PBO, Feed Section, Health Canada) and through bilateral/multilateral initiatives with the United States and other countries, the Organisation for Economic Cooperation and Development and other international initiatives.

In Canada to date, the following species of PNTs have been authorized for unconfined release: alfalfa, canola, corn, cotton, flax, lentils, potatoes, rice, soybeans, squash, sugar beet, sunflower, and wheat. Approved traits include: herbicide tolerance, insect resistance, virus resistance, male sterility/fertility restoration, and modified oil profiles.

As noted, the PBO is more familiar with agricultural field crops with PNTs than PNTs of other sectors. Other key challenges include regulatory harmonization, internally and internationally, and the cost of regulatory oversight (financial and human resources) for both government and for industry.

Turfgrass - Industry Overview and Future

Martin Pick, Pickseed

Cultivated turfgrass has been in Canada for more than 100 years. The turfgrass industry in North America includes four main species: Kentucky Bluegrass, Creeping Red Fescue, Ryegrasses, and Bentgrasses. Because of the preponderance of perennial varieties, there has not been a lot of interest by the major seed breeding companies for developing genetically modified varieties.

About 15 years ago, Agriculture and Agri-Food Canada removed the requirement for variety registration of turfgrasses. As a result, the turfgrass industry has few regulations. The Seeds Regulations contains regulatory oversight as to the purity and germination of turfgrass.

Prior to 1960, there was very little use of varieties or certified seed for turfgrasses in Canada. The seed business was dominated by flower and vegetable seed companies selling small packages of seed, along with limited bulk sales for landscape contractors, highway departments, etc. The standard mix was 40% Kentucky Bluegrass, 40% Creeping Red Fescue, and 20% perennial or annual Ryegrass.

A few significant events in the 1960s changed the industry:

• The cultivated sod business was started.
• Merion Kentucky bluegrass was developed, with outstanding adaptability to sod cultivation.
• Proprietary alternatives to Merion were introduced.
• North American rights to varieties were secured.

New varieties were developed, including Manhattan Perennial Ryegrass, and the industry capacity for development was expanded as companies introduced proprietary breeding/development programs. Rutgers University in New Jersey has emerged as the world leader in research and development of turfgrasses, and Oregon's Willamette Valley is considered the best growing location.

Canada has recently become a producer of perennial ryegrass seed, although in much smaller quantities than what is produced in the United States. Canada is essentially an importer of turfgrass seed and seed stock, with annual market value of $20 million for professional turf and $25 million for consumer turf.

Key concerns related to introducing regulation into the industry at this time include:

• Surplus quantities are usually sold as VNS (Variety Not Stated) or "common seed" with characteristics and traits not likely to be known to the importer.
• There is a lack of capacity and technical capacity at both the regulatory and commercial levels to address many issues such as trials and the determining of what is a PNT.
• There is a perception that "if it ain't broke, don't fix it."

Progress in Breeding for Important Traits in Cool-season Turfgrasses

Stacy Bonos, PhD., Assistant Professor, Turfgrass Breeding, Rutgers University, Department of Plant Biology and Pathology

Breeding turfgrass cultivars in the past focussed mainly on traits such as mowing quality, plant height, colour, density, and leaf texture. Today, breeders are targeting traits such as disease resistance, drought tolerance, salt tolerance, and rhizome production.

Reproductive systems in turfgrass include asexual (apomixis) and sexual (cross-pollinating, self-pollinating) processes. Apomixis is an asexual process whereby seed is formed without the union of sperm and egg. Plants resulting from apomixis are identical to the original plant. Kentucky bluegrass is an example of a turfgrass that reproduces through apomixis. Controlled crosses (sexual female and apomictic male) have been used to improve disease resistance, although the predictability of progeny based on parent performance is low.

Cross-pollinated species include perennial ryegrass, tall fescue bentgrass and fine fescue cultivars. Various selection techniques and breeding processes have been used to improve turf quality (such as durability, heat resistance) and address diseases such as gray leaf spot, brown patch, and dollar spot. Research has also focussed on improving drought resistance and developing cultivars that are able to withstand non-potable water supplies (salt).

4.0 NOVELTY AS A REGULATORY TRIGGER

Presentation

Plants with Novel Traits - Novelty as a Regulatory Trigger

Kirsten Finstad, Acting National Manager, Plant Biosafety Office, CFIA

The Canadian Environmental Protection Act (CEPA) came into force in 1988 and was amended in 1999. It requires any person who intends to import, manufacture or sell any new substance to notify the appropriate Canadian regulatory authority so the new substance can be evaluated for potential effects on the environment and human health. Part V of the Seed Regulations provides CEPA equivalent regulation for the environmental release of plants with novel traits.

Canada operates a product-based regulatory framework for assessing the potential risks of a plant with a novel trait on the environment, human and animal health and safety. This approach addresses products equally, regardless of the process by which the product was created (e.g., rDNA techniques, mutagenesis, cross pollination). As a result, all products, whether they are developed domestically or imported into Canada, are regulated based on whether they express a novel trait. The determination of whether a plant contains a novel trait is the responsibility of the importer, plant breeder or developer. The PBO has been working with the agriculture, horticultural and forestry industries to develop more "prescriptive" guidance for determining if a plant is a PNT.

A novel trait, as per the Seeds Regulations, is defined as "a trait that 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, based on valid scientific rationale, is not substantially equivalent, in terms of its specific use and safety both for the environment and human health, to any characteristic of a distinct, stable population of cultivated seed of the same species in Canada, with regard to weediness potential, gene flow, plant pest potential, impact on non-target organisms, and impact on biodiversity."

To be considered a PNT then, the plant in question must exhibit an intentionally introduced trait that is both new to the species in Canada and has a potential to impact the plant's environmental safety.

There are two distinct contexts for newness: introduction of a new trait; and significant modification of an existing trait. "Introduction of a new trait" means the plant in question contains a trait that was not previously expressed in a stable cultivated population in Canada. Examples include herbicide tolerance and insect resistance.

"Significant modification of an existing trait" means the plant in question contains a trait that has been identified in a stable cultivated population in Canada but is expressed at levels that are significantly outside the range of that stable population. An example would be significantly increased disease resistance. However, successive incremental changes to an existing trait, such as minor yield increases in yield in successive varieties due to ongoing long-term selection, may not be considered new.

In addition to being new to the species in Canada, a novel trait must also have a potential to impact the environmental safety of the plant. In practice, most products of conventional breeding programs are not considered PNTs, because the novel trait is not substantially different in terms of specific use and safety. Changes in a plant's compositional or morphological properties are less likely to affect the plant's environmental safety. Changes in agronomic or fitness characteristics are more likely to affect environmental safety.

Determination of novelty must be done on a case-by-case basis as it depends on the combination of the plant species and the particular trait. Baseline information about the biology of the species is essential in determining novelty.

The use of novelty as a trigger enables the regulatory system to be robust enough to deal with emerging technologies, as it is product based rather than process based. In addition, because the trigger for novelty is product based, developers are able to choose from a range of available tools to produce the best variety, rather than choosing techniques based on the potential for regulation. However, consultations with stakeholders have indicated that the concept of novelty needs clarification. Consequently the PBO is developing a guidance document to assist developers, breeders and importers of new plants in determining if a plant has a novel trait. The PBO encourages proponents to contact the PBO early in the development of new plants to discuss novelty and regulatory requirements.

Other concerns raised by stakeholders in consultations relate to the lack of biological baseline data for comparing new and existing plants in order to determine novelty, trade and marketing issues, and time and resources required for regulatory oversight and compliance.

The PBO is continuing to work with stakeholders to address these concerns to ensure the most effective and least intrusive application of the regulations. CFIA is committed to maintaining its credibility as a science-based regulator and fulfilling its responsibilities to protect the environment while not unduly hindering innovation or competitiveness.

Stakeholder Discussion and Feedback

Working in small table groups, participants considered the following questions related to novelty as a regulatory trigger:

• What are the aspects of novelty as a regulatory trigger that work/could work for your industry?
• What are the challenges that novelty as a regulatory trigger may pose for your industry?
• What recommendations can you suggest to PBO to make novelty work better for your industry?

What Works Well

Participants found the overall regulatory approach - assessment of the product rather than the process - to be positive for the turfgrass industry. The science-based aspect of the regulatory approach was also seen as a strength.

Participants supported the concept that once a novel trait is approved, the plant's progeny would acquire the same approval status. This was seen to provide for incremental improvements to the plant to be done without going through the approval process again.

It was noted that the regulatory process may deter "frivolous" plant breeding, as it will "provoke the developer to actually think about the environmental impact of the product." This should lead to improved consumer and environmental protection.

Other positive aspects of the regulatory approach noted by participants included:

• PBO is available to provide advice on questions of novelty.
• Promotes a level playing field.
• Regulation will lead to clarification of what "novel" means.
• Federal regulatory approval may limit future liability on the part of the proponent.

Concerns and Challenges

The ambiguity of the terminology used was of concern to participants. In particular, "novel," "risk," "environmental impact," and "significant" were considered to be too broad and therefore subject to varying interpretations. Additionally, the term "novel" is tied to other regulatory areas and authorities, such as Plant Breeders' Rights, Novel Feeds, Novel Foods, etc.

The nature of the turfgrass industry presents a number of challenges. First, there is virtually no breeding of turfgrasses taking place in Canada - the industry relies on imports. This raises issues around the definition of "importer" and potential tie-ins to import permits. Second, some industry members export seed that has been multiplied under contract, raising issues around acceptance in foreign markets, especially Europe. Third, there is a relatively small market in Canada for turfgrasses, and many Canadian turfgrass buyers (e.g., golf courses, landscapers) are already highly regulated. New and/or additional regulations could be onerous.

Participants noted that it could be difficult for a company to recover the costs associated with the regulatory submission process. As turfgrasses are generally a perennial crop, there is less of a consistent market for seed. In addition, the "first one in" would have to invest in the development of the Biology Document for the plant, which would then become a public document for access by competitors. This potential lack of return on investment could discourage or limit innovation, as many of the improvements aimed at the Canadian market, such as winter hardiness, would be considered novel. The introduction of environmentally-friendly traits aimed at reducing pesticide use or water use, such as disease resistant or drought resistant plants, could also be impeded.

Issues around liability were raised. Although the regulatory submission and approval process would demonstrate that a developer/breeder had done its due diligence, it was suggested that this would not provide a shield from future liability should a negative environmental impact occur. The regulatory process may, however, lessen the degree of liability. It was emphasized that nonetheless there is ongoing responsibility on the part of the proponent to ensure the product/plant remains safe following approval.

Questions were raised related to the capacity of PBO to appropriately apply the regulations to the turfgrass industry. Is there sufficient technical knowledge within PBO to assess requirements of the turfgrass industry? Are there sufficient resources? There are also industry capacity issues related to the preponderance of importers rather than breeders in Canada, including a lack of scientific expertise to determine novelty.

Other areas of concern or challenges to the turfgrass industry raised by participants included:

• If a plant is not considered to be a PNT, could that finding be challenged, and by whom (e.g., a competitor, activist group, etc.)?
• Basing novelty on the predicted environmental impact of the intended trait alone does not capture plants with unintended linked traits that may have environmental impact
• Although overall the regulation of PNTs should serve to foster a level playing field, the case-by-case approach may not have this end result, as interpretation of the requirements may vary from proponent to proponent.
• If the system is too rigorous, there is a potential risk that Canadians would be denied access to the benefits of new global seed technology.

Recommendations

Participants emphasized that "novelty" is the essence of the horticulture/ornamental/agricultural products industry, which includes turfgrasses. "Novelty," as it is used to define PNTs, has negative connotations. It was suggested that a focus on the potential risk to the environment, rather than the fact that the plant is new, would be more appropriate. It is important, however, that "environmental risk" be clearly defined, and the responsibility for risk assessment be clear.

Some participants suggested that the responsibility to determine novelty should be shifted from the breeder. It was suggested that an approval "board" (comprised of breeder/developer, stakeholders, PBO, and others) be established to determine the question of novelty.

Use of a pre-submission consultation process similar to the model use by the Pest Management Regulatory Agency (http://www.pmra-arla.gc.ca) was another idea raised. This would help proponents weigh the amount of investment and data required to proceed, against potential benefits. [Note: The PBO encourages proponents to consult with the PBO early in the development of a new plant to discuss novelty and submission requirements.]

Participants suggested that PBO should endeavour to ensure that once regulations are introduced, that they are monitored on an ongoing basis to determine effectiveness, fairness, impact on the industry, etc. A flexible, open approach should be adopted to enable necessary adjustments and refinements, particularly to facilitate an "evolution of the determinants of novelty."

It was suggested that the PBO take a holistic approach that considers potential environmental benefits as well as potential negative impacts. In this connection, consideration could be given to making financial or other support available to developers of environmentally friendly plants.

Other recommendations and advice included:

• Clarify the terms, especially "novel." Alternatively, select a term other than "novel."
• Issue a list that identifies plants that are or would be considered novel and those that are not/would not be considered novel, including those in the "gray" areas, along with explanations of why.
• Look to develop the necessary expertise in turfgrass within the PBO.
• Clarify policy on whether traits already present in the species as a whole at a low frequency can be considered novel once fixed in a cultivar.
• The focus is often on the larger industry players - it is important that PBO also listen to the smaller companies.
• Look to harmonize regulations, especially data requirements, regulatory triggers, etc., with U.S.
• Fund the development of biology documents by third parties (e.g., universities) to provide baseline data; work toward development of "global" biology documents through international organizations, such as the Organization for Economic Development (OECD).
• PBO to proactively inform and educate regarding regulation of PNTs as it relates to the turfgrass industry.

5.0 SCIENTIFIC AND REGULATORY CHALLENGES

Presentation

Development of Turfgrass Enhanced by Biotechnology

Bob Harriman, Scotts

There are many benefits derived from areas planted with turf, including safe and clean open spaces for sports, playgrounds and other activities, enhancement of water infiltration and protection from soil erosion, absorption of noise, reduction of glare, and improved air quality through the exchange of carbon dioxide for oxygen. Biotechnology can enhance the positive impacts of turfgrass on our health and our environment by leading to varieties that use less energy by requiring fewer mowings or that need less water and fewer pesticides. Glyphosate Tolerant Bentgrass (GT bentgrass), a product of biotechnology, has led to significant reductions in pesticide, insecticide, fungicide use as well as management and maintenance costs on test golf courses in the U.S. (Glyphosate is the generic name for Roundup® and other herbicides.)

Over the course of the submission period, more than 90 individual experiments conducted in 70 environments have demonstrated environmental safety. Human health and wildlife safety assessments have noted that the same gene technology used with GT bentgrass has been used in soybeans, corn and canola for more than 10 years. The glyphosate tolerance technology being used in GT bentgrass has been extensively tested for humans and animal feed safety and shown to not be a toxin or allergen. Clearance has been gained for food and feed use of GT bentgrass.

The potential for weediness is a key environmental impact that is assessed during such a review. The Weed Science Society of America conducted an assessment and issued its report that stated that creeping bentgrass and its sexual relatives are not noxious or problematic weeds and that GT bentgrass is equivalent to conventional varieties.

United States authorities responsible for the regulation of products of biotechnology are the US Department of Agriculture (USDA), the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA). GT bentgrass was submitted to each of these agencies as part of its approval process, which was initiated in Spring 2000. The process includes consultation with the regulatory agencies, collection of risk assessment data, public comment periods, stakeholder reports, an environmental impact study (EIS) and peer review. Publication of a final EIS, followed by a comment period, will lead to a final decision and determination, which will be to approve, deny, or approve with restrictions GT bentgrass for commercial release.

Stakeholder Discussion and Feedback

Some participants were surprised at the findings of the Weed Science Society of America related to the weediness of bentgrass, noting that bentgrass does indeed present key weediness concerns on playing fields. Other herbicide use is required to eradicate it (often the field has to be started again), raising concerns about the potential impact GT bentgrass could have.

It was noted that in Canada, the proponent would be required to provide a herbicide tolerance stewardship plan following approval. This could address some of the potential problems related to the U.S. system, which tends to require less oversight following deregulation.

6.0 REGULATION OF ENVIRONMENTAL RELEASE OF PNTs

Presentations

Overview of the Regulation of Imports of PNTs

Hong Chen, Environmental Release Assessment Officer, Plant Biosafety Office, CFIA

Canada's Plant Protection Act and Plant Protection Regulations provide the legal authority for the importation of PNTs. A PNT that has received authorization for unconfined release in Canada can be imported without restriction, although any conditions of approval must be observed. A PNT that has not received authorization for unconfined release (for example, a plant that would be used in research), requires a Plant Protection Import Permit to enter Canada.

The process includes completion of the "Application for Permit to Import Plants and Other Things under the Plant Protection Act." The applicant must answer, "Is any of the material a product of biotechnology (e.g., genetically modified, biologically engineered)?"

The PBO is currently reviewing the import policy for PNTs to take into consideration how plant commodities are regulated across CFIA, to explore options on how to define novelty in ornamentals, to better manage adventitious presence of unapproved events in a sustainable manner, and to address issues related to PNTs versus novel species.

The North American Plant Protection Organization Standard provides information for member countries on importation and release into the environment of transgenic plants.

Confined Field Trials

Eric Wierenga, Policy Development Officer, Plant Biosafety Office, CFIA

The purpose of confined research field trials is to enable product developers/researchers to evaluate PNTs under controlled conditions while minimizing the risk of exposure to the environment. Data generated through the confined field trial process provides information for an environmental release assessment, performance evaluation, variety registration, and/or academic research.

The CFIA's Directive 2000-07: Conducting Confined Research Field Trials of PNTs in Canada, sets out clear and concise instructions to help applicants meet the regulatory requirements for authorization or renewal of confined field trials. Applications for confined research trials are considered on a case-by-case basis.

Authorization for a confined field trial includes terms and conditions that are both general and specific to the crop-kind and the nature of the novel trait. These terms and conditions may relate to the size of the trial, reproductive isolation from related species, site monitoring requirements during the trial, disposal/destruction of plant material, seed retention, and post harvest restrictions (e.g., what type of crops can be produced in that location in subsequent growing seasons) and post-harvest monitoring requirements. All plants authorized for confined release and the terms and conditions of release are available to the public on the CFIA website.

The applicant is responsible for monitoring the trial site on a regular, established basis and for keeping the trial in compliance with the terms and conditions. The applicant must keep records of all monitoring and compliance activities. The CFIA inspects all sites, at random, for compliance to terms and conditions.

Unconfined Environmental Release Assessments of Plants with Novel Traits

Phil Macdonald, Acting National Manager, Biotechnology Environmental Release Assessment Unit (CFIA)

Unconfined release involves the release of a PNT into the environment with limited or no restrictions, generally as a step towards commercialization. An environmental release assessment (ERA) is undertaken prior to approval for unconfined release.

Directive 94-08 (Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits) provides guidance on what constitutes a PNT, defines criteria and information relative to an ERA, and describes the steps leading to unconfined release.

ERAs are comparison based (information on the PNT provided by the proponent is compared with an unmodified counterpart as set out in the biology document), science-based and builds on previous knowledge (i.e., what is already known about a new trait? Is there a history of safe use?). Information requirements are on a case-by-case basis, depending on species and the trait in question.

For an ERA, plants with novel traits are assessed against five main criteria:

• potential to become a weed or invasive;
• potential for gene flow to wild relatives;
• altered plant pest potential;
• potential impact on non-target organisms; and
• potential impact on biodiversity

A biology document needs to accompany an application for unconfined release, if not already created. Biology documents exist for sugar beets, canola, soybean, lentil, flax, potato, wheat, corn/maize, alfalfa, and durum wheat, and are currently in development for apples, Brassica juncea, creeping bentgrass, grapevine and safflower. Biology documents include general information on the plant (description, cultivation, reproductive biology, geographic distribution, habitat, close relatives, etc.), and information on potential interactions with other life forms.

Scientific information required for the application for unconfined release includes identification and classification, description of novel trait(s), modification methods, detection method, information related to the five risk criteria, and data to address guidelines from CFIA's Feeds Section and Health Canada.

Applicants may meet with PBO prior to submission to determine the status of the appropriate biology document and to discuss requirements and information gathering strategies. Following review of a submission, additional information may be requested, the application may be approved, it may be approved with conditions, or approval may be refused. Applications and outcomes are shared with international regulatory counterparts and posted on the CFIA website.

Applicants are required to contact the CFIA if/when new information becomes available and to undertake (as applicable) Variety Registration and requirements of the Pest Management Regulatory Agency (e.g., development of Herbicide Tolerance Management Plans and/or Insect Resistance Management Plans). A stewardship plan will be required and should include strategies to allow for environmentally safe and sustainable deployment and for communicating to and receiving feedback from growers regarding any problems that may arise.

To date, 61 PNTs have been approved for unconfined environmental release, including alfalfa, canola, corn, cotton, flax, lentils, potatoes, rice, soybeans, squash, sugar beet, sunflower and wheat. Approved traits have included herbicide tolerance, insect resistance, virus resistance, male sterility/fertility restoration, and modified oil profiles.

Stakeholder Discussion and Feedback

Working in small table groups, participants considered the following questions related to the regulation of environmental release of PNTs (confined and unconfined):

• What are the aspects of PBO's regulation of PNTs that work/could work for your industry?
• What are the challenges that PBO's regulation of PNTs may pose for your industry?
• What recommendations can you suggest to make PBO's regulation of PNTs work better for your industry?

General Discussion

Participants questioned the need for regulatory oversight of turfgrasses, especially when those regulations appear to be burdensome in terms of cost, time and effort. Participants noted that the nature of turfgrasses and turfgrass breeding is such that there are usually only incremental changes when new varieties are developed, plants tend to be hybrids, and there is relatively low associated environmental risk, which has been demonstrated over many years of breeding and cultivation. In addition, Canada has to be cautious not to become too demanding regarding regulatory and information requirements, or we will fall behind in terms of innovation and competitiveness, and Canadians will not have access to new, beneficial turfgrass products.

CFIA emphasized that the regulations in question apply only to plants with potential environmental risk, and that most of the turfgrasses being imported or developed would not be captured. It was noted that although the regulations for PNTs are applicable to all crops, there is flexibility in the processes related to the regulations, such as the guidelines and conditions for confined trials and processes related to environmental assessments. This is where the unique characteristics of different industries (ornamentals, turfgrasses, agroforestry) may be accommodated to ensure compliance is not overly burdensome or intrusive.

The question of who is responsible for determining whether a plant is a PNT with environmental risk was raised. There is a perception that there is a potential for unfair advantage and inconsistency due to the apparent subjectivity of the determination of a PNT. Some participants felt that this is not a concern, as liability rests with the breeder, who generally is responsible, credible and diligent. Additionally, there is a broad sense of accountability and stewardship within the research/turfgrass community. What is most important is that as much information is gathered as possible to make a scientifically sound and supportable decision.

DISCUSSION AND FEEDBACK ON CONFINED FIELD TRIALS

What Works Well

Participants noted that there is confidence in the system, which has been working well for agricultural crops. It is a proven process, based on best available science, with benchmarks and experience to draw upon.

The clear guidelines and conditions for confined trials were seen as positive, along with the openness and approachability of the PBO (for example, inspectors and proponents working together to rectify infractions). There was a perception that the system appropriately takes a pragmatic rather than precautionary approach (i.e., the system acknowledges that there will always be some risk).

Challenges and Concerns

It was noted that the regulatory system for confined trials appears to be more appropriate for annual crops than for perennial crops. Participants noted that it is important to recognize the difference between turfgrasses and agricultural crops in determining conditions and restrictions related to confined trials. The diversity of species, phenotypic similarities between species, the difficulty in identifying escapees, and the variety of reproductive modes (asexual, open pollination, self pollinated) should be considered in determining isolation distances, buffer zones, plot sizes and post harvest land use.

Another key difference is that many new turfgrass varieties have limited commercial/ market potential, and therefore potential for return on investment should also be considered through some type of accommodation for turfgrass PNTs that will have limited use.

A key concern is the limited space available for confined turfgrass trials, space which is also continually under pressure to be released for other plant types (e.g., agricultural crops). Because turfgrasses can be mowed prior to flowering, turfgrasses should not require large isolation distances or the level of post harvest land use restriction applied to agricultural crops.

Concerns were again raised regarding the lack of expertise on turfgrasses within CFIA and the burden of regulation on industry and government in terms of resources (financial and people) and the time required. Participants emphasized that it would be difficult for small companies to do the site monitoring that would be required.

Recommendations

Participants suggested that PBO consider introducing a separate oversight process for researchers and importers (versus commercial producers). Accommodating "experimental" lines would enable initial research and evaluation to take place in order to determine commercial viability and potential environmental risk without significant costs or time being spent on a complicated application processes.

In this connection, it was suggested that PBO develop an accreditation process for researchers and importers in which the person or organization would be audited by CFIA for operational due diligence. Once accredited, the researcher/importer would be able to proceed without undertaking a full submission process. This would allow Canadian researchers access to new varieties and knowledge to increase Canada's competitive edge. It was noted that the new knowledge acquired could be applied toward the biology document for the plant.

Participants underscored the importance of recognizing that confinement of turfgrasses is more easily accomplished than for other plants because they can be mowed prior to flowering. In addition, environmental risk from turfgrasses is considered very low. Therefore, standards for isolation distances, post harvest land use, etc., should not have to be as stringent as for other crop kinds. In this connection, it was recommended that PBO consider a species-specific regulatory approach that could, for example, provide separate guidelines for mowed (non-flowering) and unmowed turf, especially buffer requirements.

It was suggested that CFIA undertake regular reviews to ensure the regulatory system is keeping pace with new knowledge in order to align regulatory requirements more closely to actual risk.

Other recommendations included:

• Improve/increase CFIA/PBO expertise on turfgrass.
• Where feasible, US or foreign data should be considered.

DISCUSSION AND FEEDBACK ON UNCONFINED ENVIRONMENTAL RELEASE OF PNTs

What Works Well

Participants noted that the regulatory approach reduces risk to the environment, which is further supported by the requirement for stewardship plans. Other positive elements noted included the pre-submission process, access to statisticians and the approachability of PBO.

Challenges and Concerns

The cost to produce the required data package, in terms of both money and time, was seen as a key challenge for the turfgrass industry. This is particularly burdensome for importers, who may not have access to the required information. There are also associated liability issues for importers.

The need for biology documents was seen as particularly troublesome. Challenges include the lack of in-depth knowledge, especially on some of the minor use species; the range and variability of outcrossing potential; and financial and resource burden, especially for small companies. Importers may have additional problems, as they may not have full access to information on the plant due to proprietary restrictions.

Concern was raised around the capability of industry to deliver on stewardship plans. It was noted that that the cost of stewardship plans could be burdensome, especially if there are monitoring and enforcement elements required.

Participants emphasized that it is important that strong intellectual protection tools are in place to protect the research development investment of companies.

Recommendations

In light of the financial and time investment required to produce biology documents, participants suggested that CFIA should partner with industry or fund their production.

Other recommendations included:

• Improve expertise on turfgrasses within CFIA/PBO.
• Develop more streamlined regulations for minor use species so that it is more financially feasible to pursue approval of varieties with limited commercial/market potential.

7.0 IMPROVING COMMUNICATION AND COORDINATION

PBO sought feedback from participants on how to improve communication of information on regulation of PNTs to the turfgrass industry.

Target audiences were identified as turfgrass seed importers, breeders, turfgrass scientists, turfgrass users (such as golf course superintendents, sod producers, etc.), and other stakeholders/industry members in Canada, United States, Europe and New Zealand. The goal should be to reach and solicit feedback from select people within the target audiences, and to emphasize that the regulatory review is a "work in progress."

It was suggested that PBO attend the annual and/or regular meetings of trade associations in Canada and the United States (such as the Crop Science Society of America, Turfgrass Breeders Association, Canadian Seed Trade Association, Canadian Seed Growers Association, Golf Course Superintendents Association of North America, etc.). It was also suggested that people who have attended this workshop help "spread the word" with their colleagues who were unable to attend.

Other ideas and suggestions included:

• Place articles in trade newsletters, academic publications, etc., for example the Crop Science Society newsletter.
• Distribute the report and executive summary from this workshop.
• Set up a way to receive feedback and to engage stakeholders.
• Ask the trade associations to provide the names of 1-5 people with specialist qualifications, for selective contact/feedback.

8.0 CLOSING COMMENTS

Kirsten Finstad, Acting National Manager, Plant Biosafety Office, CFIA

This workshop has provided a wealth of information for CFIA-PBO to consider, and our knowledge and understanding of the turfgrass industry in Canada has been greatly enhanced.

CFIA-PBO recognizes that there are many unique aspects of the turfgrass industry, including the dependency on imports, the phenotypic and reproductive characteristics of turfgrasses, and the generally low potential for environmental impact associated with the majority of new turfgrass varieties. These aspects as well as the many excellent and innovative suggestions that emerged during the workshop discussions will be considered as we move forward in our review of the regulatory system for PNTs.

Workshop participants are encouraged to contact PBO with any questions or further comments.

APPENDIX - LIST OF PARTICIPANTS

• Stacy Bonos
  Rutgers University
• Yves Castonguay
  Agriculture and Agri-Food Canada
• Pam Charbonneau
  Ontario Ministry of Agriculture, Food and Rural Affairs
• Hong Chen
  CFIA - Plant Biosafety Office
• Julie Dionne
  Royal Canadian Golf Association
• Kirsten Finstad
  CFIA - Plant Biosafety Office
• Richard Goetze
  Ontario Seed Company
• Bob Harriman
  The Scotts Company
• Katerina Jordan
  University of Guelph
• Bill Leask
  Canadian Seed Trade Association
• Eric Lyons
  University of Guelph
• Phil Macdonald
  CFIA - Biotechnology Environmental Release Assessment Unit
• Virgil Meier
  USDA - Animal and Plant Health Inspection Service
• Martin Pick
  Pickseed Canada Inc.
• Ron Shiedel
  Green Horizons
• Eric Wierenga
  CFIA - Plant Biosafety Office
• Rob Witherspoon
  Guelph Turfgrass Institute
• John Benesh
  John Benesh & Associates
• Derek Ellis
  MORFA Inc.