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Phil Macdonald Plant Biosafety Office Canadian Food Inspection Agency

Regulating the Environmental Release of Plants Producing Human Vaccines: Protecting Human, Livestock and Environmental Safety. Informal consultation on the scientific basis for regulatory evaluation of candidate human vaccines from plants January 24, 2005 Geneva, Switzerland. Phil Macdonald

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Phil Macdonald Plant Biosafety Office Canadian Food Inspection Agency

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  1. Regulating the Environmental Release of Plants Producing Human Vaccines:Protecting Human, Livestock and Environmental Safety Informal consultation on the scientific basis for regulatory evaluation of candidate human vaccines from plants January 24, 2005 Geneva, Switzerland Phil Macdonald Plant Biosafety Office Canadian Food Inspection Agency

  2. REGULATORY PRINCIPLES Scientifically based Familiarity Product based Case by case Step wise Public involvement (includes research community, farm groups etc) Market issues are not considered as part of the safety assessment for environmental release Plant Biosafety Office

  3. Regulatory Pathway for Plants with Novel Traits Confined Research trials - Reproductive isolation Environmental Assessment (CFIA - Seeds Act) Livestock Feed Assessment (CFIA - Feeds Act) Novel Food Assessment (HC-Food and Drugs Act) Unconfined Approval Reduced or no Reproductive Isolation Authorized Livestock Feed Ingredient No Objection Human Food Use Variety Registration Commercialization Corn - No Var. Reg. Commercialization

  4. Trait trends 1989-2004 (trials) Plant Biosafety Office

  5. Plant Molecular Farming • Production of human vaccines in plants will meet Canada’s definition of plant molecular farming • In Canada plant molecular farming has been defined as: “The use of PNTs for the production of a pharmaceutical or industrial biomolecule rather than for food or feed” Plant Biosafety Office

  6. How is plant molecular farming different from other uses of PNTs? Not meant for food or feed Same type of risks as other PNTS- but non-target effects are not as well known or predictable – predator-prey interactions, rhizosphere, etc. Enhanced public concerns about potential risks consequences of adventitious mixing into commodities could be serious for industry and human health Plant Biosafety Office

  7. How is plant molecular farming different from other uses of PNTs? Commercial production of vaccines will likely require some level of confinement or even containment In these cases, granting unconfined cultivation would be unlikely so on-going regulatory oversight will be required Plant Biosafety Office

  8. CFIA’s Areas of Concern How to protect the environment How to keep PNTs used for plant molecular farming, including vaccine production out of conventional commodities Avoiding gene flow Providing effective regulatory oversight Plant Biosafety Office

  9. CFIA’s Areas of Concern CFIA experience has shown that despite the best efforts of the industry towards high levels of stewardship compliance problems can still occur Public and media very aware of the consequence as a result of some high profile compliance issues to related to plant molecular farming It is important that regulatory policy proceed cautiously to avoid compromising the integrity of the CFIA’s oversight – public confidence imperative Plant Biosafety Office

  10. CFIA’s Areas of Concern Choice of platform: • Use of food and feed crops • Pros: • agronomics well known • less likely to be invasive • generally regarded as safe • may be used for edible vaccines Plant Biosafety Office

  11. CFIA’s Areas of Concern • Use of food and feed crops • Cons: • potential adventitious mixing leading to: • public concern • industry concern • health concerns Plant Biosafety Office

  12. How has the CFIA Addressed these Concerns? Reviewing the oversight and terms and conditions of confined field trials of PNTs for molecular farming More comprehensive consideration of applications since 2001 (Health Canada and Feed Section involved if the platform is a commodity crop) Working on policy development in areas where higher risk exists (co-mingling with food and feed crops) Plant Biosafety Office

  13. How has the CFIA Addressed these Concerns? Convened multi-stakeholder consultation - Oct/Nov 2001 to discuss confined field trials for plant molecular farming Proposed amendments to Regulatory Directive (Dir 2000-07) for confined trials - Dec 2001 (stakeholder input) Interdepartmental consultations (continuing) In addition, the CFIA is working closely with USDA counterparts on harmonizing approaches Plant Biosafety Office

  14. Proposed Amendments to Dir2000-07 to deal with PNTs for molecular farming Developed fall 2001 Posted for comments Dec 21, 2001 Comments received from industry, academics and government agencies Comments and incorporated into draft policy Plant Biosafety Office

  15. Interim Conditions for 2004 Health Canada and/or Feed Section, CFIA assessments of toxicology/ allergenicity data for food/feed crops discourage use of major food/feed crop species Plant Biosafety Office

  16. Interim Conditions for 2004 • Minimum isolation distances may be increased • isolation 2X for food/feed crops, other measures considered case-by-case basis, dependant on crop biology • 4 X when adjacent to seed production fields • no livestock grazing or food production w/in 50 metres Plant Biosafety Office

  17. Interim Conditions for 2004 Some enhancement of existing inspection activities outside of normal current- season field inspections inspectors will be present for any disposal or destruction of any residual plant material Plant Biosafety Office

  18. Interim Conditions for 2004 restrictions on post-harvest land use for food and feed production may apply These requirements will be reviewed for 2005 growing season Plant Biosafety Office

  19. Future Challenges • Containment standards • Imposing mandatory IP systems – licensing required? • What type of ongoing regulatory oversight/ inspection will be required? • How to evaluate long-term and non-target effects – what are suitable indicator species and acceptable experimental protocols? • What are the limits on permissible production field sizes? Plant Biosafety Office

  20. Future Challenges cont’d Remaining current with evolving technology development Balancing land-use pressure with maintaining adequate confinement Developing contingency plans for accidental breaches of confinement Establishing testing and monitoring protocols Plant Biosafety Office

  21. Recommendations Establishing Good Agricultural Practices Defining “Safety Preservation” systems Direct involvement of Health Canada Explore genetic mechanisms for confinement for higher risk products Establish licensing system for “molecular farmers” Plant Biosafety Office

  22. Meeting the Challenges Technical Expert Workshop on Segregation and Handling • CFIA convened an expert technical workshop on segregation and handling to look at the applicability of existing systems to plant molecular farming • Standard operating procedures, guidance for good agricultural practice, testing and detection methods and contingency planning were discussed Plant Biosafety Office

  23. Meeting the Challenges An executive summary of the proceedings of the workshop is available on the CFIA website Complete proceedings and presentations have been posted on the Plant Biosafety Office web site Input from this workshop has formed an important component of draft Guidelines on commercial scale plant molecular farming that will be discussed by experts at a workshop in March 2005 CFIA is working with other Federal partners to make sure all aspects of the production have been considered for oversight- horizontal governance CFIA and USDA –APHIS are developing a common document that will describe “best practices for plant molecular farming Plant Biosafety Office

  24. Developing the Regulatory Pathway • Need to develop a regulatory system that addresses health and environmental safety concerns while not unduly inhibiting innovation • Can not proceed without broader policy review to better understand the benefits and risks including effects on the agriculture sector – recognition that this is not a zero risk activity Plant Biosafety Office

  25. Developing the Regulatory Pathway CFIA is holding a technical workshop in March 2005 with experts to discuss potential draft guidelines for commercial cultivation- draft guidelines and discussion document shared in advance Plant Biosafety Office is meeting with inspection staff to discuss resource implications and begin discussions on development of “Specific Work Instructions” Plant Biosafety Office

  26. Developing the Regulatory Pathway • Canada’s Regulatory Framework for Biotechnology stresses the need for regulations to be in harmony with national goals • Regulators are looking for a context to assess “acceptable risk” for plant molecular farming • Broader policy review will help inform regulatory policy • Agriculture-Agri-Food Canada is exploring the best means to proceed with this review and its scope • CFIA is the science-based regulator in this process Plant Biosafety Office

  27. Developing the Regulatory Pathway Resulting Regulatory pathway should: • reflect stakeholder input/concerns • protect health safety and the environment • be responsive to evolving science and technology • be consistent with international standards Plant Biosafety Office

  28. Conclusion The CFIA continues to work with its government partners, the biotechnology industry, the food industry, consumers and other stakeholders to develop a regulatory way forward that will protect health and environmental safety while allowing Canadians the option of capturing the benefits of plant molecular farming Plant Biosafety Office

  29. Conclusions New and evolving area: big challenges for the biotech industry, government, farm community and agri-business We need to find a way to move forward while maintaining high standards for environmental, human and livestock health Plant Biosafety Office

  30. Web Site http://www.inspection.gc.ca/english /plaveg/pbo/pbobbve.shtml http://www. inspection.gc.ca/francais /plaveg/pbo/pbobbvf.shtml Plant Biosafety Office

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