REPORT OF THE WORKSHOP ON:
TURFGRASS PLANTS WITH NOVEL TRAITS

"Straight Drive or Dog Leg Left?
What is the Least Intrusive and Most Effective Way to Regulate the Environmental Release of Turfgrass Plants with Novel Traits?"

SUMMARY VERSION

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 CFIA-PBO in examining our regulatory system.

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 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 concerning the relevant issues facing the turfgrass industry regarding the environmental release of PNT, and for turfgrass importers and breeders to gain better understanding of how the Canadian regulatory system for PNT might apply to their industry. 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 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 plant-based sectors, including the turfgrass industry.

PRESENTATIONS

• The following presentations were given at the workshop:
• 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
• Regulatory Oversight of Environmental Release of PNT, 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, Rutgers University, Department of Plant Biology and Pathology
• Plants with Novel Traits - Novelty as a Regulatory Trigger, Kirsten Finstad, Acting National Manager, Plant Biosafety Office, CFIA
• Scientific and Regulatory Challenges of Developing a Genetically Modified Round-up Ready Creeping Bentgrass Submission, Bob Harriman, Scotts Co.
• Overview of the Regulation of Imports of PNT, Hong Chen, Environmental Release Assessment Officer, Plant Biosafety Office, CFIA
• Confined Field Trials, 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

Workshop Session 1: Novelty as a Regulatory Trigger

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 aspects of the regulatory approach were 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.

Other positive aspects noted included:

• PBO's availability to provide advice on questions of novelty
• the regulatory approach promotes a level playing field
• regulation will lead to clarification of what "novel" means
• and federal regulatory approval may limit future liability on the part of the proponent.

Concerns and challenges

Participants expressed concern that the terminology used is ambiguous, in particular "novel," "risk," "environmental impact," and "significant" were considered to be too broad and therefore subject to varying interpretations. Additionally, "novel" is used in other contexts, such as Plant Breeders' Rights.

The nature of the turfgrass industry presents unique challenges. First, there is virtually no breeding of turfgrasses taking place in Canada - the industry relies on imports. 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.

Participants emphasized that "novelty" is the essence of the horticulture/ornamental/agricultural products industry, which includes turfgrasses. "Novelty", as it is used to define PNT, 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.

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.

Recommendations

The following recommendations and suggestions were put forward during the workshop (note that inclusion here is not meant to imply unanimous support by participants):

• PBO should adopt a flexible approach to enable necessary adjustments and refinements to regulations, particularly to facilitate an "evolution of the determinants of novelty."
• Place emphasis more on potential environmental risk rather than new novel traits.
• PBO should take a holistic approach that considers potential environmental benefits as well as potential negative impacts. Consideration should be given to making financial or other support available to developers of environmentally friendly plants.
• The responsibility to determine novelty should be shifted from the breeder. The creation of a novelty determining body, comprised of breeders/developers, stakeholders, PBO, and others, was suggested.
• Establish a pre-submission consultation process similar to the model use by the Pest Management Regulatory Agency (PMRA), which would help proponents weigh the amount of investment required to proceed, against potential benefits.
• Clarify terms, especially "novel."
• Issue a list that identifies plants that are or would be considered novel and those that are not/would not be considered novel.
• 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.
• Look to develop the necessary expertise in turfgrass within the PBO.
• PBO to proactively inform and educate regarding regulation of PNT as it relates to the turfgrass industry. Ensure both large and small companies are consulted.
• Look to harmonize regulations with the U.S.
• Continue to ensure that regulatory decisions and actions are science-based.

Workshop Session 2: Regulation of Environmental Release of PNT

General discussion

Participants questioned the need for this type of regulatory oversight for turfgrasses, noting that the nature of turfgrasses and turfgrass breeding is such that there are usually only incremental changes when new varieties are developed and there is relatively low associated environmental risk, which has been demonstrated over many years of breeding and cultivation. Canada has to be cautious not to become too demanding regarding regulatory and information requirements, or we risk falling behind in terms of innovation, competitiveness and consumer access to beneficial turfgrass products.

CFIA emphasized that the regulations in question apply only to PNT with environmental risk and that most of the turfgrasses being imported or developed would not be captured. It was noted that although the regulations for PNT 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. A perception that there is a potential for unfair advantage and inconsistency due to the apparent subjectivity of the determination of a PNT was discussed. What is most important is that as much information is gathered as possible to make a scientifically sound decision.

Concerns were again raised regarding the lack of expertise on turfgrasses within CFIA, the burden of regulation on both industry and government in terms of resources (financial and human) and the time required.

Confined field trials

Participants noted that there is confidence in the system for confined field trials, as it has been working well for agricultural crops. The clear guidelines and conditions for confined trials were seen as positive, along with the openness and approachability of the PBO. There was a perception that the regulatory system appropriately takes a pragmatic rather than precautionary approach.

However, the regulatory system for confined trials appears to be more suitable for annual crops (agricultural crops) than for perennial crops (turfgrasses). Characteristics of turfgrasses, including the diversity of turfgrass 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. For example, because turfgrasses can be mowed prior to flowering, large isolation distances or the level of post harvest land use restriction applied to agricultural crops should not be required. Consideration should also be given to the limited commercial/market potential of many turfgrasses (and thereby limited use/exposure), and the recognized low environmental risk.

Recommendations

The following recommendations and suggestions were put forward during the workshop (note that inclusion here is not meant to imply unanimous support by participants):

• Develop flexible, species-specific regulations for confined field trials that provide:
  • Special treatment for turfgrass PNT that have limited commercial/consumer use
  • Separate guidelines for mowed (non-flowering) and unmowed turf, especially buffer requirements.
• Clarify guidelines.
• Allow U.S. and other foreign data to be considered.

Unconfined environmental release

Positive elements related to the unconfined environmental release of PNT noted by participants included the pre-submission process, access to statisticians and the approachability of PBO. Participants noted that the regulatory process reduces risk to the environment, which is further supported by the requirement for stewardship plans. However, there were concerns around the capacity of industry to provide monitoring and enforcement elements of stewardship plans.

The cost to produce the required data package, including the biology document, 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 may also be associated liability issues for importers.

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

Recommendations

The following recommendations and suggestions were put forward during the workshop (note that inclusion here does not suggest unanimous support by participants):

• Fully fund or co-fund the development of biology documents by proponents or third parties to provide baseline data and work toward development of "global" biology documents through international organizations.
• Develop more streamlined regulations so that it is more financially feasible to pursue approval of varieties with limited commercial/market potential.
• Develop consumer/industry education to promote correct product use.

Workshop Session 3: Improving Communication and Coordination

PBO sought feedback from participants on how to improve communication of information on regulation of PNT to the turfgrass industry. Target audiences were identified as turfgrass seed importers, breeders, turfgrass scientists, turfgrass users and other stakeholder/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 U.S., and that people who have attended this workshop help "spread the word" with their colleagues.

Other ideas and suggestions included:

• Place articles in trade newspapers and academic publications.
• 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.

Closing Comments and Next Steps

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 CFIA-PBO moves forward in its review of the regulatory system for PNT.