APPLICATION BRIEFING

GM bacteria: potential uses and

concerns
Overview
Genetically modified (GM) bacteria have
been used in industry and research for
many decades, but under strict controls that
prevent their release
Naturally occurring bacteria are often used
in agriculture and medicine
New technologies and understanding mean
there is potential to use GM bacteria to
improve agricultural yields and human
Recent developments in scientific understanding
health
and technology mean that GM bacteria have
Currently, no GM microorganisms are
great potential for benefit to human health and
authorised within the UK or EU for use in
nutrition. GM crops have been a subject of
food or medicine
widespread public debate (POSTnote 386),
There are specific considerations involved in
whereas there is far less public awareness about
the release of GM bacteria that differ from
the uses for and issues surrounding GM bacteria,
those relating to plants
particularly in regard to use outside of agriculture.
Each genetically engineered bacterial
When discussing the release of GM bacteria,
product has its own associated risks and
similar considerations must be made about the
benefits, depending on the function and the
environmental and health risks, as well as
bacteria and technology used in its creation
philosophical and religious concerns.
Background Box 1: Biocontainment mechanisms
Genetic modification (GM) refers to the process by which A variety of tactics have been used to limit the proliferation of GM
either a pre-existing gene is modified or a new gene (a bacteria into the environment. Many of the genes that are inserted into
bacteria come at a fitness cost, meaning that the presence of the
transgene) is inserted, in such a way that would not occur
transgene makes the bacterium less able to compete against non-
naturally. This was first achieved in 1973 when E. coli was modified bacteria, and therefore these bacteria are unlikely to thrive
engineered to carry a resistance gene to the antibiotic outside of controlled conditions. Bacteria used in industry are often
kanamycin1. Since then, GM bacteria have been used stripped of non-essential genes that are required to grow competitively in
extensively in research and industry, often for the production complex environments but are unnecessary in single culture. In addition
of compounds and proteins, but under strict containment to this, bacteria are often engineered to lack key genes in such a way
that prevents them from surviving without the supplementation of key
protocols.
nutrients. However, it has been shown that bacteria are able to
overcome this containment through horizontal gene transfer 3 (Box 2).
Current regulation
The current framework regulating the release of GMOs in Another strategy is the use of ‘kill switches’ whereby the antibiotic
the UK is Directive 2001/18/EC. GM for food and feed is susceptibility of the GM bacterium is characterised and then these
antibiotics are used to kill the bacteria. Due to the antimicrobial
also regulated by Regulation 1829/2003. These regulations
resistance concerns involved in the wide-scale use of antibiotics, this
are extensive enough so as to effectively entirely prohibit would only be feasible for the use of GM bacteria in humans and not in
the release of GMOs, and no GMO has been approved for agriculture. The risk of the bacterium acquiring genes for antibiotic
release in the UK since they came into effect. This prevents resistance and therefore not being able to be killed can be reduced by
any commercialisation of live GM bacteria for use in using bacteria that are susceptible to a wide range of antibiotics 3.
medicine or agriculture. A recent European Commission
study found these regulations no longer fit for purpose2.
Potential uses Concerns
Agriculture The spread of GM bacteria and genes outside of their
Naturally occurring bacteria have been used in agriculture to intended use is not in itself a hazard, but they may have
protect crops from damage, for example from pathogens, unintended effects that do constitute hazards.
frost, or pests, or to improve yield by enhancing nutrition.
These are generally derived from bacteria with pre-existing Risks to the environment
evolutionary relationships with crops. Genetic engineering Depending on the species and inserted genes, GM bacteria
has the potential to make these bacteria more effective, can survive and proliferate in soil anywhere from a few
combine several activities into one strain, and aid tracing of weeks to several years. Farming practices may spread
bacteria to monitor their success and potential harms. This bacteria between fields5. Prior knowledge of the species in
creates the potential to increase crop yields without the use question can be used to assess how long it is likely to
of chemicals that have adverse effects on the environment persist and any impact it may have, including on native
and ecosystems5. microorganisms, larger organisms, and ecosystem
processes. Organic farmers are also concerned about the
Medicine widespread use of GMOs as they are required to show the
Genetically engineered bacteria have been used in absence of GM DNA in their products for some
medicine since 1978 when bacteria were first engineered to certifications10.
produce insulin, but their use up until now has been limited
to the production of biological products. When these Risks to health
products are purified, the bacteria are removed and The risk to health posed by a GM bacterium can be
therefore not released into the environment. assessed using prior knowledge of the characteristics of the
parent organism and the inserted transgene. “Qualified
In recent years, there has been an increased appreciation Presumption of Safety” is a framework used for the safety
for the role of the microbiome, particularly the gut assessment of microorganisms. If the parent bacterial
microbiome, in human health. This has led to interest in the species has a known QPS status, the only further safety
development of Live Biotherapeutic Products (LBPs) in the assessment required is of the effect of the genetic
form of bacteria. These differ from probiotics, which are modification8. This includes any changes to the ability of the
bacterial products for the benefit of human health but are organism to cause infection, or produce toxins or allergens,
not permitted to be labelled with any claim of efficacy whether these changes are intended or unintended. Where
against disease. Engineered live bacterial therapeutics the GM bacterial treatment is intended for use by the
could continually deliver drugs and have the potential to vulnerable, for example in cancer treatment, the risk may be
detect and respond to biological signals in the body. GM higher due their weaker immune systems. The risk profile of
LBPs are currently in development to target diseases such the transgene can be assessed through knowledge of its
as cancer, diabetes, and phenylketonuria4. properties in the ‘donor’ organism, or if the gene is synthetic,
through its homology to known genes.
Currently, most LBPs require continual delivery and cannot
colonise the human body long-term. Long-term colonisation Antimicrobial resistance
would enable more continuous delivery and better patient During the genetic engineering of bacteria, antibiotic
compliance, but also increase risk. More study is required to resistance genes are often used to select for successful
understand the dynamics of GM LBPs in patients. transformants. Given the current threat of antimicrobial
resistance and the potential for these resistance genes to be
The UK is in a good position to become a leader in the passed to pathogenic bacteria, it has been suggested by
development of GMOs due to our existing scientific some that any antimicrobial resistance genes are removed
expertise. from GM bacteria before their release9.

Box 2: Horizontal gene transfer Intellectual property

Bacteria can share DNA in many ways. Not all bacterial species are The issue of patents for GMOs is complex. GM bacteria are
capable of these processes and they are more likely between, but not mobile, and this may cause issues of ownership if they
entirely confined to, bacteria of the same species 6. It is also more likely spread. There are also concerns that patenting naturally
in environments densely populated with bacteria, such as soil or the
human gut. Whether the gene is retained by the bacterial population occurring genes will limit scientific research.
and spreads more widely is determined by the fitness advantage
provided by the gene8. Most engineered genes come at a fitness cost, Tracing GMOs
which limits their spread. The ever-reducing cost of genetic sequencing and improved
tools for environmental monitoring will make tracing easier
In addition to this, genetic recombination allows genes to move around
the bacterial chromosome and between the chromosome and mobile in the future. GM bacteria can also be engineered with
genetic elements. These phenomena create the possibility of marker genes that enable easier tracing3. Surveillance can
transgenes spreading to different species of bacteria but the likelihood be used to monitor for any detrimental effects to the
depends on properties of parent species, the technology used to environment following the release of GM bacteria.
modify it, and the transgene itself.
References
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