Lecture 3_Regulation of biotechnologies Flashcards
(17 cards)
What is a genetically modified organism (GMO) under Australian law?
An organism modified by gene technology;
One that inherits modified traits from another GMO;
Anything declared a GMO by regulation – excluding some human therapies (somatic cell therapy) and natural mutations
What is gene technology?
Any technique that modifies genes or genetic material, except sexual reproduction, homologous recombination, or techniques excluded by regulation
What is the OGTR?
The Office of the Gene Technology Regulator is the main Australian authority overseeing GMO dealings and enforcing the Gene Technology Act
What does the OGTR do?
Issues licences for GMO dealings
Certifies containment facilities
Monitors and inspects GMO research sites
Conducts public consultation and risk assessments
What is considered a ‘dealing’ with a GMO?
Includes making, breeding, culturing, importing, transporting, using in production, disposing of, or intentionally releasing GMOs
What are the five types of GMO dealings?
Exempt dealings
Notifiable Low Risk Dealings (NLRDs)
Dealings Not Involving Intentional Release (DNIR)
Dealings Involving Intentional Release (DIR)
Emergency Dealing Determination or inclusion on the GMO Register
What are exempt dealings?
Very low-risk dealings that must be contained and follow set procedures (e.g. basic lab cloning with non-toxic DNA)
What is a Notifiable Low Risk Dealing (NLRD)?
Low-risk, contained work (e.g. PC1 or PC2, PC3) that must be pre-approved by an Institutional Biosafety Committee
(eg, PC1: Use of a genetically modified mouse where no selective advantage has been conferred as a result
of the modification
PC2: use of genetically modified mice and rats that have a selective
advantage by the genetic modification
PC3: A NLRD criteria that involves a Risk Group 3 agent (e.g., HIV in cell culture).)
What is a DNIR?
A licence for higher-risk work with no environmental release; requires OGTR approval (e.g. toxin gene cloning)
What is a DIR?
Approval for trials or commercial release of GMOs into the environment (e.g. GM crops or viral vectors in clinical trials)
Why is physical containment important in GMO regulation?
To prevent accidental release of GMOs and protect researchers and the public
What are the four PC levels used in Australia?
PC1: Minimal risk (e.g. E. coli lab strains)
PC2: Moderate risk (e.g. Helicobacter pylori)
PC3: Higher risk (e.g. Yersinia pestis)
PC4: Highest risk (e.g. Ebola virus)
What techniques are not considered gene technology?
IVF, embryo rescue, mutagenesis, natural processes like transduction or conjugation, and nucleic acid introduction without genome alteration
What organisms are not considered GMOs?
Those altered by exempt processes or natural mechanisms, and organisms like humans who’ve received somatic cell gene therapy only
What is a gene drive?
A method to spread a specific gene through a population, used in controlling disease vectors and pests, with many ethical and technical concerns
What was the significance of the 1975 Asilomar Conference?
It initiated the framework for the safe use of recombinant DNA and led to early containment guidelines
How did Australia respond to the rise of genetic technologies?
It implemented voluntary oversight (1975–1987), then national legislation (2000) in response to public concern
