Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.
Clarifying the regulation of genome editing in
Australia – current considerations
Situation for food
Dr Lisa Kelly
OECD Co...
Regulatory landscape
In Australia, GM food is regulated under the food regulatory system,
not the Gene Technology Scheme
0...
FSANZ and the food regulatory system
• A statutory agency within
the Australian Government
Health portfolio
• Develops foo...
Food produced using gene technology
• Standard 1.5.2 – Food produced using gene technology
• a joint standard with New Zea...
09/07/2018 5
Effect of standard
Conventional breeding
• cross-breeding and selection
• mutation breeding (plants)
• cell c...
Genome editing and Standard 1.5.2
• Genome editing encompasses a wide range of genome
changes
• Genome editing for targete...
FSANZ review
• A review was commenced in June 2017 to consider:
• whether the current definitions remain fit for purpose g...
09/07/2018 8
Risk considerations – genome editing
• What sort of food products are likely to be developed?
• How do these ...
09/07/2018 9
Review process and progress
• Provide advice on the science, food safety and stakeholder concerns
• Input int...
Post-review
• At the completion of the review, FSANZ will decide whether to
prepare a proposal to amend the Code
• Amendme...
09/07/2018 11
Copyright
© Food Standards Australia New Zealand 2018
This work is copyright. You may download, display, print and reprodu...
Upcoming SlideShare
Loading in …5
×

Regulatory aspects associated to genome editing in Australia - situation for food- Lisa Kelly

187 views

Published on

This presentation clarifies the regulation of genome editing associated to food in Australia, with a view to discussing approaches to address them.

Published in: Environment
  • Be the first to comment

  • Be the first to like this

Regulatory aspects associated to genome editing in Australia - situation for food- Lisa Kelly

  1. 1. Clarifying the regulation of genome editing in Australia – current considerations Situation for food Dr Lisa Kelly OECD Conference on Genome Editing: Applications in Agriculture – Implications for Health, Environment and Regulation 28 – 29 June, 2018 Paris, France
  2. 2. Regulatory landscape In Australia, GM food is regulated under the food regulatory system, not the Gene Technology Scheme 09/07/2018 2 Standard 1.5.2
  3. 3. FSANZ and the food regulatory system • A statutory agency within the Australian Government Health portfolio • Develops food standards for Australia and New Zealand – Australia New Zealand Food Standards Code • Not responsible for enforcement 09/07/2018 3 ENFORCEMENT Aust - State & Territories, Agriculture (imported foods) NZ - Ministry of Primary Industries • States and territories • NZ MPI • Agriculture (imported foods) FSANZ Standards Coordination Advice • Standards • Coordination • Advice POLICY Forum on Food Regulation (Ministers) Forum on Food Regulation (Ministers)
  4. 4. Food produced using gene technology • Standard 1.5.2 – Food produced using gene technology • a joint standard with New Zealand • pre-market safety assessment and approval system for food • mandatory labelling requirements for approved food produced using gene technology • Standard adopted in 1999 • pre-dated the establishment of the Gene Technology Scheme • The definition for gene technology in the Code is based on recombinant DNA techniques – i.e. a process-based trigger • most approved foods are derived from transgenic organisms 09/07/2018 4
  5. 5. 09/07/2018 5 Effect of standard Conventional breeding • cross-breeding and selection • mutation breeding (plants) • cell culture techniques Gene technology • Recombinant DNA techniques • transgenesis No presumption of safety Formal risk assessment applied Conventional foods have a presumption of safety based on history of safe use Pre-market approval not required Pre-market approval required
  6. 6. Genome editing and Standard 1.5.2 • Genome editing encompasses a wide range of genome changes • Genome editing for targeted gene addition is clearly captured by Standard 1.5.2 • It’s unclear whether other types of edits come within the scope of the Standard • large deletions • nucleotide substitutions • small indels • Complicated by the uncertain status of null segregants under the Standard 09/07/2018 6
  7. 7. FSANZ review • A review was commenced in June 2017 to consider: • whether the current definitions remain fit for purpose given the emergence of other techniques (including genome editing) • whether there is justification in terms of risk for subjecting derived foods to pre-market safety assessment and approval • The FSANZ review is separate and independent from other reviews currently ongoing in Australia which also address new technologies: • Technical Review of the Gene Technology Regulations • Third Review of the National Gene Technology Scheme 09/07/2018 7
  8. 8. 09/07/2018 8 Risk considerations – genome editing • What sort of food products are likely to be developed? • How do these compare to conventional foods already in the food supply with a history of safe use? • What is the potential to develop products with novel food risks? Can we apply a presumption of safety to food derived using genome editing?
  9. 9. 09/07/2018 9 Review process and progress • Provide advice on the science, food safety and stakeholder concerns • Input into development of the consultation paper EXPERT ADVISORY GROUP MEETINGS • Australian and New Zealand Government agencies with interest in genome editing • Government agencies with responsibility for enforcing the Code and food policy TARGETED CONSULTATION • February – April 2018 – now completed PUBLIC CONSULTATION • In preparation • July 2018 PRELIMINARY REPORT • End 2018 FINAL REPORT
  10. 10. Post-review • At the completion of the review, FSANZ will decide whether to prepare a proposal to amend the Code • Amendments to the Code must follow a strict legislative process • A separate process to the review • Would involve additional public consultation • The Food Standards Australia New Zealand Act 1991 lists specific criteria that FSANZ must have regard to when assessing proposed amendments to the Code 09/07/2018 10 Protection of public health and safety Consumer information Costs and benefits of the proposed amendment Risk analysis using best available scientific evidence Efficient and competitive food industry Consistency with relevant policy
  11. 11. 09/07/2018 11
  12. 12. Copyright © Food Standards Australia New Zealand 2018 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 information@foodstandards.gov.au www.foodstandards.gov.au or www.foodstandards.govt.nz /Food.Standards @FSANZnews 09/07/2018 12

×