Current Perspectives on Biotechnology:
Projects and Future
Challenges/Opportunities
Jordan Bean
Novel Foods Section
Health Canada
Dr. Jaimie Schnell
Plant Health and Biotechnology
Risk Assessment Unit
CFIA
May 7, 2013
Overview
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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)
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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
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Proposed Low-Level Presence (LLP) Policy
• LLP policy applies to:
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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
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Stakeholder comments under review
Summary of key issues will be reported on Agriculture and
Agri-Food Canada (AAFC) website
Proposed Low-Level Presence (LLP) Policy
• Proposed LLP policy available at:
http://www4.agr.gc.ca/AAFC-AAC/displayafficher.do?id=1348076201400&lang=eng
• Inquiries
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Agriculture and Agri-Food Canada (AAFC) is the contact point
for this policy: LLP-PFC@agr.gc.ca
Insertional Effects Paper
• Insertional effects
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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
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• 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.
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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
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• Framework for novelty determination of ‘process’
category
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Guidance for Industry on Novelty Determination of High
Pressure Processing (HPP)-Treated Food Products
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)
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What criteria should be met?
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
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Improving Procedures for Pre-submission
Consultation
• Pre-submission consultation procedures for novel
foods, novel feeds and plants with novel traits
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Guidance formalized in 2010
• Working group (Health Canada, CFIA, CropLife
Canada)
March 2013 meeting
> Draft of revised guidance document in progress
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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
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• 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?
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• 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)
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Known trait, unknown/hypothetical mode of action
• How much do we need to know about the mode of
action?
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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
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Mode of action
Newest molecular assay
• This may be perceived as a gap in the safety assessment
Decision-makers
> Public
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• 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
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Research results are available to the public
• Ensures that national approaches are consistent with
international thinking
• Used in risk communication with public
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Supports decisions and policy approaches
Research Needs
• Validate new molecular tools
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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)?
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• Baseline data on appropriate comparators
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Enhance existing data and create data for other major crops
• Animal biotechnology
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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
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• Crops without a history of safe use
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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?
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For More Information Concerning Novel Foods and
Plants With Novel Traits in Canada
Novel Foods
Health Canada Web address:
http://www.hc-sc.gc.ca
HC-Novel Foods Web address:
http://www.novelfoods.gc.ca
Novel Feeds
Animal Feed Division address:
http://www.inspection.gc.ca/
animals/feeds/eng/1299157
225486/1320536661238
Plants With Novel Traits
CFIA Web address:
http://www.inspection.gc.ca
CFIA–Agricultural Biotechnology
Web address:
http://www.inspection.gc.ca/
english/sci/biotech/biotech
e.shtml
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