Food regulatory perspective on gene editing

Transcription

1 Food regulatory perspective on gene editing Lisa Kelly Risk Assessment Biological Sciences CSIRO Gene Editing of Crops Workshop November 2017 Kiama, Australia

2 ANZ food regulatory system FSANZ statutory objectives in standards setting: protection of public health and safety provision of adequate information relating to food to enable consumers to make informed choices prevention of misleading or deceptive conduct 2

3 In the beginning No distinction in food law between GM food and any other food 1999 Adoption of Standard Food produced using gene technology Pre-market approval system for GM foods 3

4 Standard Part of the Australia New Zealand Food Standards Code(the Code) Establishes a pre-market assessment and approval system for foods produced using gene technology Imposes mandatory labelling (in certain circumstances) for approved foods Approved foods are listed in Schedule 26 of the Code Over 70 approved foods approved, all derived from either transgenic or intragenic plants 4

5 Key definitions Determine what foods are captured for pre-market approval All methods not considered to be gene technology are regarded as conventional breeding Foods not captured by definitions may enter the food supply without an application to FSANZ still required to comply with all other aspects of food law gene technology means recombinant DNA techniques that alter the heritable genetic material of living cells or organisms a food produced using gene technologymeans a food which has been derived or developed from an organism which has been modified by gene technology conventional breeding means all methods used to produce plants, excluding techniques that use gene technology 5

6 Pre-market approval is based on process Conventional foods have presumption of safety based on history of safe use Conventional breeding Traditional cross breeding & selection Mutation breeding (plants) Cell culture techniques No pre-market approval Gene Technology Recombinant DNA techniques Transgenesis Pre-market approval No presumption of safety, formal risk assessment applied 6

7 Gene editing -the issue for food Uncertainty about whether foods from gene edited crops are captured by Standard Debate about whether foods from gene edited crops should be captured under Standard If captured: ARE THEY CAPTURED? SHOULD THEY BE CAPTURED? application required for pre-market approval, submission of data package to support a safety assessment approved foods subject to mandatory labelling as GM foods. 7

8 Food from gene editing is it captured? Open to interpretation recombinant-dna techniques not defined..derived or developed from.. Relates to both the edit itself, and how the technique has been deployed Deletions and nucleotide substitutions (SDN-1, SDN-2, ODM) Use of null segregant lines FSANZ is not a regulator! FSANZ is not responsible for enforcement of the Code or its interpretation and application 8

9 Gene editing should it be captured? Has turned the spotlight back onto GM foods how and why we regulate them, do we extend this approach to new technologies Why did we originally impose a pre-market approval system for GM foods? What have we learned from 20 years of regulating GM foods? Should this approach be extended to gene editing? 9

10 What is FSANZ doing? In June 2017, FSANZ commenced a review to consider new breeding techniques, including gene editing The objectives of the review are to consider what foods should be captured for pre-market assessment and approval under Standard whether the definitions for food produced using gene technology and gene technology need to be amended 10

11 What has to be decided? Food from gene editing: Is general food law sufficient to protect public health and safety? Do we need an additional process to provide assurance such foods are safe? All food is regulated All food must be safe and suitable 11

12 FSANZ approach to the review FSANZ will apply a risk-based approach to the question of what foods should be captured focus will be on the characteristics of the food itself No longer makes sense to make distinctions based on process, or use of a specific technique In relation to gene editing consider the targeted changes that can be introduced and their impact on the food characterise the potential food safety risk from off-target changes 12

13 To capture or not capture a risk-based approach Targeted changes What sort of food products can be developed now and into the future? How do these compare to conventional foods already in the food supply which have a history of safe use? What is the potential to develop novel products with potential food safety risks? Can we apply a presumption of safety to food from gene editing? Off-target changes What is their frequency, potential food safety risk? How do they compare to random changes that occur using chemical or radiation mutagenesis, or that occur spontaneously? Can they be predicted and screened for? Should we be concerned about off-target changes from a food safety perspective 13

14 Process The review is expected to take about 12 months to complete The review will involve the following: Consultation with an expert advisory group Development of an issues paper for public consultation (early 2018) Preparation of a review report 14

15 After the review FSANZ will decide whether to amend relevant definitions in the Code Undertaken as a separate process to the current review Would consider a number of other relevant issues, in addition to the science Additional public consultation provision of information to consumers to enable them to make informed choices maintaining confidence in the food supply ensuring regulation is proportionate to the risk and provides a net benefit enforceability of the standard promoting an efficient and internationally competitive food industry compatibility of definitions with other regulatory schemes 15

16 Review website: gmfood/pages/review-of-new-breedingtechnologies-.aspx Look out for the issues paper in early

17 Copyright Food Standards Australia New Zealand 2017 This work is copyright. You may download, display, print and reproduce this material in unaltered form only (retaining this notice) for your personal, non-commercial use or use within your organisation. Apart from any other use as permitted under the Copyright Act 1968, all other rights are reserved. Requests for further authorisation should be directed to or 17