Fostering Seed Innovation

Transcription

1 CSTA ACCS Canadian Seed Trade Association L Association canadienne du commerce des semences Fostering Seed Innovation

2 Canadian Seed Trade Association L Association canadienne du commerce des semences About the CSTA Founded in 1923, CSTA is a national trade association that brings together more than 130 company members engaged in all aspects of seed, from research and development to production and marketing and domestic and international trade. CSTA members serve the needs of their farmer customers by developing seed utilizing all available production methods and range from small, family owned and operated companies, to large multinational firms. Our members work with over 50 different crop kinds, ranging from field crops to garden and vegetables. This submission was prepared jointly by CSTA and CropLife Canada, the trade association representing the manufacturers, developers and distributors of plant science innovations, including pest control products and products of plant biotechnology, for use in agriculture, urban and public health settings. The Canadian Seed Trade Association welcomes the CFIA s openness and transparency initiative and appreciates the opportunity to provide feedback in the context of the CFIA s oversight of plants with novel traits and novel feeds. These regulatory programs directly affect our members activities and have significant influence on investment and commercialization decisions therefore enhanced transparency around the requirements of these programs is important. Furthermore, CropLife Canada s own public polling research shows that the CFIA continues to be highly respected and trusted by the Canadian public. The regulatory oversight provided by the CFIA to the plant science industry, which includes its public communications and transparency, coupled with our industries ongoing commitment to raising public awareness is central to maintaining and building public trust in this space. 130 Albert Street, Suite 500, Ottawa, Ontario, K1P 5G4 P: F: E: csta@seedinnovation.ca seedinnovation.ca

3 How can the CFIA provide Canadians with more useful, timely and accessible information about food safety, animal health and plant protection to help them make informed decisions? Information about the CFIA s procedures and the rationale behind them, such as descriptions of the scientific rigour of CFIA s regulatory practices, is of benefit to Canadians especially when made available in a timely manner. Likewise, information about specific regulated products can promote confidence in those products and in the Canadian regulatory system for both Canadians and our export markets. However, there is concern that the extensive, highly technical and scientific information provided by companies to CFIA for regulatory purposes could be misinterpreted by the public if released out of context. CSTA members are committed to ensuring safety and regulatory compliance of their products and as such there has never been a safety concern with any seed or feed developed by them under the plants with novel traits or novel feeds programs. We note the possibility that publication of some information about specific regulated parties or their products may be misconstrued, particularly if not presented in context. In such a case, the information may not help Canadians make informed decisions and may cause unnecessary confusion, unfortunate loss of trust in the regulator and unwarranted harm to the regulated party and potentially jeopardize Canada s international trade goals. CSTA urges the CFIA to consult regulated parties about any specific new information it is considering publishing so that stakeholders can assist in the analysis of potential benefits and the management of potential areas of confusion. CSTA notes that plant breeders and developers of new plant varieties could make better informed decisions about the plant breeding objectives guiding their innovative work if the regulatory triggers and information requirements for novel feeds and plants with novel traits were enhanced to be more clear, objective and unambiguous. See our response to the next question for further elaboration. Which additional information and tools could the CFIA provide to help industry comply with regulatory requirements? The CFIA s current practices place responsibility on plant breeders and developers of new plant varieties to self-determine whether a new plant triggers regulation as a novel feed and/or plant with novel trait. Unfortunately, from an industry perspective the guidance provided by the CFIA to assist in making this determination is becoming increasingly subjective as the science underpinning innovation in this sector evolves. This places significant pressure on breeders and developers due to the lack of clarity around

4 regulatory triggers. It has also led to documented inhibition of innovation by breeders and developers seeking to avoid unknowingly triggering regulations1. Many innovative ideas that are consequently not being pursued have potential to significantly further the Government of Canada s environmental and economic goals as articulated by the report of the Advisory Council on Economic Growth and elsewhere. CSTA calls on the CFIA to develop transparent, unambiguous and concrete definitions of novelty and novel traits in feed and seed that minimize subjectivity. This would greatly assist breeders and developers to understand the regulatory status of a new plant. The CFIA should also further collaborate with Health Canada to ensure that all regulatory triggers for novel products are aligned and equally transparent and objective. CSTA also requests that the CFIA outline an efficient voluntary mechanism for breeders and developers of new plants to seek a determination of novelty status from the Government of Canada in situations where uncertainty remains. This process should include stated timelines and provide a means for regulators to confirm the novelty status of an intended trait based on a description, scientific rationale, and where necessary minimal data, provided early on in a development or breeding program. This process would promote regulatory compliance and mitigate adverse effects on innovation by clarifying the regulatory status of a breeding objective in advance of significant investment in R&D. In addition to clear, unambiguous regulatory triggers, CSTA calls for well-defined tiered regulatory requirements proportional to the potential risk of the plant and feed. Ensuring that information requirements are clear and not unduly onerous is in line with CFIA s commitment to a risk-based approach and will significantly help industry in complying with regulations. Breeders and developers will be more likely to innovate if they are aware in advance of the regulatory requirements and if these do not pose undue burden. We further request that CFIA set and adhere to service time standards for assessment processes including completeness checks, preliminary assessments and other components of regulatory reviews. Enhancing efficiency of regulatory requirements and processes will mean that Canadian producers have quicker access to innovative products. CSTA strongly encourages CFIA to continue its previous practice of consulting Canadians on changes to regulatory policies and guidelines. Related to this, CSTA would like to state its concern for the lack of consultation completed on substantive changes (related to reviews of similar products) recently made to

5 Directive Assessment criteria for determining environmental safety of plants with novel traits. 1 Although the changes are viewed by CSTA as largely positive they have significant impacts on our members ability to comply with regulatory requirements therefore these types of changes would benefit from a more thorough consultative process in the future. How can the CFIA share more information about its compliance and enforcement activities? CSTA welcomes the CFIA s commitment to applying a risk-based approach to protect Canadians, and to clearly explain the scientific reasons for its regulatory decisions. A consistent reliance on science for regulatory decisions will continue to engender the trust and respect sought by the CFIA from Canadians and the international community as mentioned in the CFIA s proposed Open and Transparent Agency Framework. We strongly encourage the CFIA to ensure that the scientific and risk basis of all its regulatory activities, including for the development of new policies and practices as well as specific decisions, is communicated clearly to the public and stakeholders in support of this commitment. CSTA supports government transparency in relation to its ongoing compliance and enforcement activities when this provides useful information to Canadians. To be meaningful, any published information about specific non-compliances must be clearly related to potential risks to Canadians (e.g. health or economic) and must be presented with relevant context such as industry-wide compliance rates and corrective actions taken by industry. CSTA notes the potential for publication of industry non-compliances to cause unwarranted harm to reputation of businesses, particularly for cases such as non-compliances that do not result in harm to the public or environment or technical non-compliance issues that are immediately corrected. Publication of such records could easily be misinterpreted by readers when presented out of context. We urge CFIA to consult regulated parties about any specific compliance and enforcement information it is considering publishing so that stakeholders can assist in the analysis of potential benefits and the management of potential areas of confusion. As previously described the onus for novelty determination is placed on the plant breeder under Canada s current regulatory program for plants with novel traits and novel feeds which CSTA supports as an overall 1 /eng/ / ).

6 approach. However, given the need for enhanced guidance under which to make that determination, the opportunity exists for a plant breeder to incorrectly complete such a determination. To aid plant breeders in making these determinations CSTA requests the CFIA to develop a voluntary process by which plant breeders can ensure their novelty determinations are accurate. In addition, the CFIA should clarify its anticipated response to a hypothetical environmental release or livestock feed use of a new plant determined to be not novel by its breeder or developer but determined to be novel by the CFIA. CSTA seeks clarity on the compliance and enforcement actions that could be expected in such a situation and how they would be proportional to risk. What can the CFIA do to help stakeholders and the public learn more about regulatory science, and have access to research and information from CFIA scientists? CSTA encourages the CFIA to enhance its communications to Canadians about the strong science and rigour behind its regulation of novel feeds and plants with novel traits. There has never been a safety concern associated with a plant with a novel trait or its related feed or seed in Canada. Strong proactive communication about the rigourous scientific and risk basis of CFIA safety assessments of novel products will promote confidence in the regulatory system and may mitigate unfounded safety concerns among the Canadian public and our export markets.

7 CSTA ACCS Canadian Seed Trade Association L Association canadienne du commerce des semences 130 Albert Street, Suite 500, Ottawa, Ontario, K1P 5G4 P: F: E: csta@cdnseed.org cdnseed.org