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Biotechnology in Practice > L20 Regulating Gene Tech > Flashcards

L20 Regulating Gene Tech Flashcards

1
Q

Why do we have a regulatory scheme?

A

see onenote

recombinant DNA emerged from a series of advances in biochem - especially from discoveries of new enzymes such as restriction enzymes and ligases

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2
Q

Concerns and Outcomes during the 70s

A

see onenote

  • concerns about cloning of genes involved in cancer, derived from viruses or toxin-producing organisms
  • could we be making organisms that are more dangerous or mobile than the non-modified organism
  • in 1976, in the US, recombinant DNA guidelines were published
  • Guidelines focused on containment and work practices
  • defined responsibilities of investigators, research institutions and government
  • focused on containment and protection based on level of risk
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3
Q

What was happening in Australia?…But there were still concerns

A

see onenote slides and side notes

  1. 1975 - guidelines
  2. 1981 - voluntary regime
  3. 1987 - non-statutory body
  • penalties used to encourage compliance such as the withdrawal of funding, cancellation of tax concessions, disclosure of breaches, common law actions
  1. 1992 - regulatory framework
  2. 2001 - nationally consistent regulatory scheme developed
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4
Q

Australia’s Gene Tech Regulatory Scheme

A

see onenote

  • work with GMOs is regulated in Aus
  • based on system of approvals and prohibitions

Gene Technology Regulator responsible for administering regulatory system
- independent statutory office holder with independence and power to regulate “dealings” with GMOs

Office of the Gene Technology Regulator (OGTR)

  • admin support to Gene Technology Regulator
  • OGTR staff are part of the Department of Health
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5
Q

Regulator and OGTR functions include…

A

see onenote

  1. coordinators consultations
  2. assesses applications and issues approvals
  3. certifies biocontainment facilities for work with GMOs
  4. monitors and inspects facilities and sites where work with GMO is conducted
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6
Q

Object of the Act

A
  1. to protect health and safety of people and to protect the enviro.
  2. identifying risks posed by or as a result of gene tech
  3. managing those risks through regulating certain dealings with GMOs
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7
Q

What is a GMO?

A

see onenote

  • an organism that has been modified using gene tech
  • an organism that has inherited traits from an organism (e.g. genetically modified parent) where the traits that occurred in the parents organism were because of gene tech
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8
Q

GMO - common examples

A

see onenote

  • pesticide resistant plants
  • transgenic animals
  • CRISP editing
  • change DNA sequence
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9
Q

Non-regulated techniques and organisms

A

see onenote

  • definition of GMO and gene tech is very broad
  • regulations include list of specific techniques and organisms that are not considered gene tech or GMOs

E.g. IVF, mutagenesis by radiation/chemical, naturally occurring mutant organism, human being undergone somatic cell gene therapy, mutant organism in which mutational event did not involve introduction of foreign DNA

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10
Q

What is a dealing with a GMO?

A

see onenote

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11
Q

How the regulatory system works?

A

see side note

  • dealings with GMOs in AUS require license from Gene Technology Regulator unless the dealings can meet specific criteria
  • organisations wishing to conduct gene tech/work with GMOs will generally become accredited by the OGTR
  • accredited organisations must have, or have access to, an Institutional Biosafety Committee (IBC) in order to be an OGTR Accredited Organisation
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12
Q

The different types of dealings

A

see onenote

  1. exempt dealings
  2. notifiable low risk dealings (NLRDs)
  3. dealings not involving intentional release in the enviro (DNIR)
  4. dealings involving intentional release (DIR)
  • on the GMO register
  • emergency dealings e.g. equine influenza vaccine
  • inadvertent dealings
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13
Q

Schematic of regulatory scheme

A

see onenote

Lots of transparency

  • Applications made publicly available on the website, public can voice their concerns
  • There are lots of organisations you have to liaise with if you want to take a GMO product out to market
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14
Q

Review

A
  • aus has a nationally consistent regulatory scheme for gene tech
  • the scheme evolved due to concerns with emerging tech that enables the manipulation of genes across species
  • aim is to protect health and safety of people, the enviro, by identifying risks posed by or as a result of gene tech, and by managing those risks through regulating certain dealings with GMOs
  • legislation extends to research, production, transport, storage, destruction, or import of live or viable organisms modified by gene tech, including progeny or descendants of GMOs sharing the genetically modified trait
  • you need to know this because every dealing with GMO needs to be licensed by the Gene Technology Regulator unless the dealing meets specific criteria
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15
Q

BananaVax Enterprises (BVE) - where do you start?

A

see onenote

  1. recommend BVE applies to become OGTR accredited organisation
  2. explain to BVE management that…
  3. BVE forms an IBC
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16
Q

You remind BVE management

A

see onenote

17
Q

Developing the GM bananas

A

see onenote

  • cloning DNA for antigens into E.coli
  • tweaking promoter so that the genes are expressed in plants
  • exempt dealings - low risk
18
Q

Growing GM bananas in containment facilities

A

see onenote

  • transforming banana plants with the vectors created in E.coli
  • use agrobacterium-mediated transformation or particle bombardment
  • you decide to also try CRISP
  • classified as notifiable low risk dealing (NLDR)
19
Q

Exempt dealings

A
  • safe hosts and vectors
  • partial genes
  • approximately 30 years of use without incident
  • work can be undertaken in PC1 lab (no OGTR certification required)
20
Q

notifiable low risk dealing (NLDR

A
  • dealings must be assessed and authorised by BVE IBC
  • has to be conducted in OGTR certified PC2 facilities e.g. glass house or laboratory
  • difficulties with containing propagative material
21
Q

Field trials and commercial crops

A
  • small scale field trials to determine “real life” performance if GM bananas is ready commence
  • commercial scale planting of GM bananas is the ultimate goal

this requires a license to intentionally release the GMOs - dealing involving intentional release (DIR)

22
Q

dealing involving intentional release (DIR)

A
  • 2 year process
  • consultations (2 rounds if risk is significant)
  • heavily monitored
23
Q

Why does it take so long to obtain a license?

A

see onenote

  • preparation of a Risk Assessment and Risk Management Plan (RARMP)
  • consideration is based on the risks to the health and safety of people and the enviro.
  • benefits are specifically excluded
  • social, economic and marketing risks are not included
  • consultation, consultation, consultation…
24
Q

What else do you need to consider?

A

see onenote

  • you advise BVE management that other regulatory agencies may need to be involved such as TGA etc…
25
Q

Meanwhile…

A

see onenote and side notes

  • BVE keeps and eye on other organisations modifying bananas such as UoQ which is already modifying bananas to be resistant to a fungus deadly in Cavendish bananas
  • you consider recommending BVE conduct work in the US - why?
26
Q

BananVax is finally released…

A

see onenote

  • hotly debated
  • uncertain whether bananavax can export the GMO bananas because of the technique used to create the GM bananas and different regulatory schemes overseas

Biotechnology in Practice (25 decks)

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