GENE TECHNOLOGY LEGISLATION

Transcription

1 NBTS AND AND AUSTRALIAN GENE TECHNOLOGY LEGISLATION Dr. Michael Dornbusch Office of the Gene Technology Regulator Australia

2 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 Australian Pesticides & Veterinary Medicines Authority

3 Technology and regulation 1 st DNA transfer 1946 GM tobacco plant produced 1983 Flavr Savr tomato in USA 1995 Bt cotton in Australia 1996 GM cotton comprises 95% of crop th DIR licence 2013 Asilomar Conference 1975 Voluntary oversight begins in Australia Genetic Manipulation Advisory Committee (GMAC) 1987 Gene Technology Act and Regulations 2001 Review of GT Act 2005 Discussion of new breeding technologies 2010 Review of GT Act 2011

4 Gene technology in late 1990 s 35S gene nos 10 Explanatory Memorandum for GT Act Gene technology involves the modification of organisms by the direct incorporation or deletion of one or more genes to introduce or alter a specific characteristic or characteristics

5 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

6 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

7 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

8 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.

9 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

10 INTENTION OF GT ACT DEFINITIONS OF GT A Gene technology/gmo definition designed to have a broad capture Regulations intended to provide criteria to exclude organisms and/or techniques which: Give rise to organisms that occur in nature so have no unique biosafety risks Commonly used in biological research Long history of safe use

11 Year genome editing Targeted mutagenesis Oligo-directed mutagenesis Transient expression Cisgenesis and intragenesis

12 RANGE OF TECHNIQUES Oligonucleotide direct mutagenesis RNAi Cisgenesis Grafting Zinc Finger Nucleases TALENs Meganucleases CRISPRs Negative segregants

13 REGULATOR S APPROACH Range of possible applications and outcomes of technologies-general advice difficult Provide advice on case-by-case basis Careful examination of the technical details, processes used and final organism produced in relation to the relevant provisions of the Act and the Regulations. Work with other regulatory agencies to harmonise approaches wherever possible within legislative restrictions

14 CONSIDERATIONS Did it involve gene technology? Look in detail at process making the organisms Definition in the Act and Schedule 1A regulations- techniques excluded Is it a GMO? Did it inherit traits from a GMO? Schedule 1- Is it excluded? eg did the mutational event involve the introduction of foreign nucleic acid?

15 SOME EXAMPLES - SDNS

16 SOME EXAMPLES RNAi Introduced silencing constructs eg hairpin Not so new technology Approved 19 field trials since 2002 Poppies, wheat and barley, papaya, ryegrass, cotton Special risk assessment method required?

17 TYPICAL DEVELOPMENTAL PATHWAY Experiments in laboratory or glasshouse ( contained ) Field trials (with limits & controls) Commercial release (with minimal controls)

18 Risk assessment approaches Same risk assessment methodology applies Specific information in application may differ Look at each case-by-case

19 Risk Assessment simple questions RISK ASSESSMENT CONTEXT What could go wrong? How could harm occur? Risk identification/scenario EVIDENCE (causal pathway to harm) 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

20 RNAi risk assessment Same risk assessment methodology Product of introduced genetic material =RNA No new protein produced Don t look at toxicity/ allergenicity of protein product

21 Risk Assessment broad considerations A GM plant is a plant Plants developed using NPBTs are still plants Phenotype is important for risk assessment Able to identify weediness/invasiveness traits Weediness/invasiveness traits encompass all undesirable effects All harms GMO BIOLOGY Harms from weeds Potential harms from GM plants

22 FUTURE WORK ON NBTS Independent review of the Act in 2011 considered the coverage of new technologies. Government response to the review now finalised. The review recommended and all governments supported : Investigate regulatory scope to reduce ambiguity and ensure that it keeps up with technology

23 Copyright Office of the Gene Technology Regulator 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