Current Perspectives on Biotechnology: Projects and Future Challenges/Opportunities Jordan BeanDr. Jaimie Schnell Novel Foods SectionPlant Health and Biotechnology Health CanadaRisk Assessment Unit CFIA May 7, 2013

2 Overview Who we are Low-Level Presence (LLP) Policy Insertional Effects Paper New Guidance for Novel Foods Improving Procedures for Pre-submission Consultation Future Challenges/Opportunities Research in Support of Regulation

Who we are… Health Canada is responsible for regulating novel foods, including those derived from biotechnology The Canadian Food Inspection Agency is responsible for regulating novel feeds and the environmental release of plants with novel traits

Proposed Low-Level Presence (LLP) Policy Low-Level Presence (LLP) > Unintended presence, at low levels, of unauthorized genetically modified (GM) crops in imported grain, food or feed; where the GM crop is authorized for food use in one or more countries but is not authorized in Canada Proposed Domestic Policy on the Management of Low-Level Presence of Genetically Modified Crops in Imports and its Associated Implementation Framework > Minimize disruptions to trade, protect health and safety of humans, animals and the environment > Facilitate effective and efficient risk-based management of LLP > Provide transparency and predictability for importers/exporters 4

Proposed Low-Level Presence (LLP) Policy LLP policy applies to: > All imported grain, food, and feed products which contain LLP where: − the GM crop approved for use as food in at least one country and, − Canada recognizes that the safety assessment conducted is consistent with Codex Food Safety Assessment Guidelines. Consultation period: Nov.6, 2012 to Jan.19, 2013 > Stakeholder comments under review > Summary of key issues will be reported on Agriculture and Agri-Food Canada (AAFC) website 5

Proposed Low-Level Presence (LLP) Policy Proposed LLP policy available at: afficher.do?id= &lang=eng Inquiries > Agriculture and Agri-Food Canada (AAFC) is the contact point for this policy: 6

Insertional Effects Paper Insertional effects > The genetic changes in the host plant’s genome that may result from the insertion of DNA during genetic engineering Compare insertional effects to other types of genetic change that plant genomes undergo > Naturally occurring > Conventional breeding Consider implications for safety assessments

New Guidance for Novel Foods 3 types of novel foods under Food and Drug Regulations: > Products that do not have a history of safe use as a food > Foods resulting from a process not previously used for food > Foods that have been modified by genetic manipulation, also known as genetically modified foods, GM foods, genetically engineered foods or biotechnology-derived foods. 8

New Guidance for Novel Foods Novelty flowchart for ‘history of safe use’ category > Potential for the development of a decision tree > Increasing transparency and predictability/consistency with determining a history of safe use for these foods Framework for novelty determination of ‘process’ category > Guidance for Industry on Novelty Determination of High Pressure Processing (HPP)-Treated Food Products 9

New Guidance for Novel Foods Guidance and tools for novelty determination of other novel foods a possible future objective (e.g. products containing phytosterols, DHA, EPA) > What criteria should be met? 10

Improving Procedures for Pre-submission Consultation Joint project between Health Canada, CFIA and CropLife Canada Fall Forum 2012 > Predictability and communication identified as high priorities for both government and industry to improve regulatory process for products of plant biotechnology > Improvement of Pre-submission Consultation process 11

Improving Procedures for Pre-submission Consultation Pre-submission consultation procedures for novel foods, novel feeds and plants with novel traits > Guidance formalized in 2010 Working group (Health Canada, CFIA, CropLife Canada) > March 2013 meeting > Draft of revised guidance document in progress 12

Future Challenges/Opportunities Fit for Purpose Data New Modes of Action Risk Communication

Fit for Purpose Data There is a growing capacity to generate more extensive data: > New complex trait development > More sensitive testing methods > Substantial increases in computing power and bioinformatics > Genomic analysis is cheaper and faster More data does not always lead to more precision in a safety assessment

Fit for Purpose Data Molecular data is a useful guide but the phenotypic, compositional, and toxicological characterization have been the main tools for assessing substantial equivalence and the lack of unintended effects There should be a link between the information we ask for and the defined end-points of the safety assessment (i.e. data is fit for purpose) > What information do these molecular assays provide? > Is the data relevant for the safety assessment? Safety assessments will be more efficient when data is fit for purpose

New Modes of Action Familiarity with single function proteins with simple modes of action (e.g. EPSPS, Cry proteins) New traits are achieved through new, more complex modes of action (e.g. RNAi, transcription factors) > Known trait, unknown/hypothetical mode of action How much do we need to know about the mode of action ? > Evaluating the mode of action can tell you where to focus your risk assessment

Risk Communication For some submissions, specific data or information is not relevant for a given safety assessment > Mode of action > Newest molecular assay This may be perceived as a gap in the safety assessment > Decision-makers > Public Need effective risk communication strategies to maintain confidence in safety assessments when we omit data or information that is not fit for purpose

Research in Support of Regulation Enhances knowledge for risk assessment and risk management Helps inform decision-making Enhances transparency > Research results are available to the public Ensures that national approaches are consistent with international thinking Used in risk communication with public > Supports decisions and policy approaches

Research Needs Validate new molecular tools > Robust, sensitive, but also fit-for-purpose Pleiotropic effects > Are some modes of action more prone to pleiotropic effects? > When and how do we assess these? > Molecular versus phenotypic characterization (weight of evidence)? Baseline data on appropriate comparators > Enhance existing data and create data for other major crops Animal biotechnology > Methodology challenges > Baseline data - what is the appropriate comparator? > Low sample sizes, longer development time for samples > What tissues/components should be analyzed? > Methods to support traceability of products in food/feed chains

Research Needs New traits > Nutritionally enhanced crops > New stress-induced metabolites in abiotic stress resistant crops Crops without a history of safe use > What is an appropriate comparator? Establishing equivalence of novel proteins > Between proteins (plant versus reference), events > How significant are differences in sequence, activity, expression levels?

For More Information Concerning Novel Foods and Plants With Novel Traits in Canada Novel Foods Health Canada Web address: HC-Novel Foods Web address: Novel Feeds Animal Feed Division address: animals/feeds/eng/ / Plants With Novel Traits CFIA Web address: CFIA–Agricultural Biotechnology Web address: english/sci/biotech/biotech e.shtml

22