Overview of the regulation of GM crops in Australia

Transcription

1 Overview of the regulation of GM crops in Australia Will Tucker Office of the Gene Technology Regulator Comparative situation of new plant breeding techniques Seville September 2011

2 OBJECT of the Gene Technology Act 2000 To protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with GMOs

3 Integrated Regulation of GMOs & GM Products OGTR regulates GMOs. Some overlap with other agencies Avoid duplicating regulation where another agency has oversight Align decision making as far as possible Herbicide tolerant GM crops human food safety is assessed by FSANZ & herbicide use is regulated by the APVMA FSANZ Food Standards Australia New Zealand Food standards and labelling TGA Therapeutic Goods Administration Human medicines & medical devices OGTR Office of the Gene Technology Regulator Live & viable modified organisms www. nicnas.gov.au NICNAS National Industrial Chemicals Notification & Assessment Scheme Authority APVMA Agricultural Pesticides & Veterinary medicines Authority

4 Scope of the gene technology legislation Dealings with GMOs prohibited unless appropriately authorised Comprehensive assessment framework Accreditation of organisations Certification of contained facilities Public Record of GMOs & GM products Monitoring and enforcement powers

5 What is regulated Live & viable genetically modified organisms (GMOs) GMO-ness (not parent organism) Research Production Culture Breeding Import What is NOT regulated by OGTR Cloning Other modification techniques Comparison with other technologies Intellectual property Cost/benefit considerations Trade & market impacts Transport

6 Types of Authorisations Low risk contained dealings (Notifiable low risk dealings [NLRD] and Exempt dealings) Licence: Dealings Not Involving Intentional Release (DNIR) Licence: Dealings Involving Intentional Release (DIR) into the Australian environment Licence: Inadvertent dealings GMO Register Emergency authorisations (by Minister) Each licence decision require a Risk Assessment & Risk Management Plan (RARMP)

7 Typical developmental pathway Experiments in laboratory or glasshouse ( contained ) Field trials (with limits & controls) Commercial release (with minimal controls)

8 Dealings Involving Intentional Release 90 DIR licences issued since limited & controlled trials 13 commercial releases (11 agricultural)

9 Commercial GMO Approvals 1 Carnation 7 Cotton * (3 current) 2 Canola * 1 Rose Altered flower colour 1st on GMO Register Insect resistance Herbicide tolerance Herbicide tolerance Hybrid breeding system * + FSANZ & APVMA approval Altered flower colour 1 Cholera vaccine (live) + TGA approval 1 Japanese Encephalitis vaccine (live) + TGA approval

10 How we regulate DIR process APPLICATION Notification of receipt issued Maximum time period for decision 255 working days Does application qualify as a limited & controlled release? Yes No Seek advice on matters to be considered from experts, agencies & authorities Limited & controlled releases, 150 working days 170 days if significant risk PREPARATION OF RISK ASSESSMENT & RISK MANAGEMENT PLAN (RARMP) Consider whether significant risk to people or environment CONSULTATION ON RARMP MINIMUM 30 DAYS (50 DAYS IF SIGNIFICANT RISK) Seek submissions on the RARMP from public, experts, agencies & authorities DECISION, LICENCE CONDITIONS Notification of decision, RARMP & licence on website

11 How we Regulate RISK ANALYSIS FRAMEWORK Apply risk analysis methodology to identifying and managing risks INTERNATIONAL STANDARDS AND GUIDANCE DOCUMENTS

12 Components of OGTR risk analysis Licence application Risk context Risk communication Risk assessment Monitor and review Risk management plan Issue a licence? No licence Yes Licence Monitor for compliance

13 Establishing Risk Context LEGISLATIVE REQUIREMENTS (Gene Technology Act and Regulations) RISK ANALYSIS FRAMEWORK OGTR OPERATIONAL POLICIES AND GUIDELINES PROPOSED DEALINGS Proposed activities with the GMO Proposed limits of the release Proposed control measures GMO Introduced genes (genotype) Novel traits (phenotype) PREVIOUS RELEASES RECEIVING ENVIRONMENT PARENT ORGANISM Origin and taxonomy Cultivation and use Biological characterisation Ecology Environmental conditions Agronomic practices Sexually compatible relatives Presence of similar genes

14 Establishing Risk Context

15 Risk assessment What could go wrong? EVIDENCE How could harm occur? Risk identification (Risk scenarios) How serious could the harm be? Consequence assessment How likely is harm to occur? Likelihood assessment UNCERTAINTY What is the level of risk? Risk estimation

16 Risk characterisation Likelihood assessment How likely is the identified harm to be realised? Determine the steps / occurrences in each risk scenario that are necessary for a harm to be realised How likely are each of these steps to occur? In the context of the relevant - timeframe - dealing ( level( of exposure)

17 Risk characterisation Consequence assessment What is the scale of harm? What is the magnitude of harm? Is the harm reversible? How long will it take the harm to be realised? How long would it last?

18 Risk assessment estimate of the level of risk

19 Risk management What treatment measures are available? How effective are they? How feasible/practical are they? Could they introduce or exacerbate risk? Which measures provide optimum/desirable level of management If risks cannot be managed to protect people and the environment then approval cannot be given

20 Risk Communication open and transparent Seek public comment on the consultation RARMP - newspaper advertisements - Australian Government Gazette - OGTR website - /mail to stakeholders Seek comment from prescribed experts, agencies & authorities

21 Risk Communication open and transparent

22 Definitions The Gene Technology Act 2000 gene technology means any technique for the modification of genes or other genetic material, but does not include: a) sexual reproduction; or b) homologous recombination; or c) any other technique specified in the regulations

23 Definitions The Gene Technology Act 2000 genetically modified organism means: a) an organism that has been modified by gene technology; or b) an organism that has inherited particular traits that occurred in the initial organism because of gene technology; or c) anything declared by the regulations to be a GMO; but does not include: d) a human being, if the human being is covered by paragraph (a) only because [of] somatic cell gene therapy; or e) an organism declared by the regulations not to be a GMO

24 Definitions The Gene Technology Regulations 2001 Schedule 1A Techniques that are not gene technology 1. Somatic cell nuclear transfer (not involving GM material) 2. Electromagnetic radiation-induced mutagenesis 3. Particle radiation-induced mutagenesis 4. Chemical-induced mutagenesis 5. Fusion of animal or human cells, if unable to form a viable whole animal or human 6. Protoplast fusion, including fusion of plant protoplasts 7. Embryo rescue 8. In vitro fertilisation 9. Zygote implantation 10. A natural process (not involving GM material) Examples of natural processes include conjugation, transduction, transformation and transposon mutagenesis.

25 Definitions The Gene Technology Regulations 2001 Schedule 1 Organisms that are not GMOs 1. A mutant organism in which the mutational event did not involve the introduction of any foreign nucleic acid (that is, non-homologous DNA, usually from another species) An organism that results from an exchange of DNA if: (a) the donor species is also the host species; and (b) the vector DNA does not contain any heterologous DNA

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