Written by 
While CRISPR-Cas9 holds immense potential for treating diseases and improving health, it’s essential to acknowledge the associated dangers and ethical concerns. Here’s a breakdown of some key risks:
Unintended consequences: Off-target effects: The Cas9 enzyme might cut unintended regions of DNA, leading to unexpected mutations and potential health problems.
Mosaicism: Editing only a portion of cells in an embryo or individual can create a mosaic of genetically different cells, potentially causing unpredictable issues.
DNA damage: The process of cutting and repairing DNA can itself be harmful, especially if not controlled accurately.
Ethical concerns: Germline editing: Modifying the human germline (sperm, eggs, embryos) would create inheritable changes, raising concerns about unintended consequences for future generations and potential misuse.
Designer babies: The potential for using gene editing to create “designer babies” with desired traits raises ethical and social dilemmas regarding equality and access.
Eugenics: Concerns exist about potential misuse for discriminatory purposes or creating a genetic underclass.
Other considerations: Long-term effects: The technology is relatively new, and the long-term consequences of manipulating the human genome are unknown.
Informed consent: Ensuring proper understanding and consent for individuals undergoing gene editing procedures is crucial.
Regulation: Establishing adequate regulations and oversight is essential to prevent misuse and ensure responsible development.
It’s important to remember that research into CRISPR-Cas9 and gene editing is ongoing, and scientists are working to address these challenges. However, it’s important to remain informed about the potential dangers and engage in open and ethical discussions about its development and application.
If you’re interested in learning more, here are some reputable sources:
National Human Genome Research Institute (NHGRI)
National Institutes of Health (NIH)
Strict ethical and safety standards are crucial for the responsible and beneficial application of the technology. Ongoing research and discussions within the scientific and ethical communities aim to guide the development and use of CRISPR technology in a responsible and transparent manner. However there is also considerable resistance to legislative frameworks from both the scientific community and commercial interests, both of whom are geared to the commercial benefits that might accrue from a successful implementation and the prestige associated with it. As usual, one would expect financial benefit to far outweigh ethical considerations, and for the lobbyists and legal profession to become heavily involved.
There is legislation in various countries, including Australia, the US, UK, Europe, and Canada, that sets guidelines on the use of gene editing technology. However, the regulations vary depending on the specific type of gene editing and its intended use.
Here’s a brief overview:
Australia:
- Gene Technology Act 2000: This legislation regulates the use of gene technology in all applications, including human therapeutics, agriculture, and research. It requires a risk assessment and approval process for most gene editing activities. Opens in a new window www.amazon.com Gene Technology Act 2000, Australia
- Prohibition of Human Cloning for Reproduction Act 2002: This Act prohibits human germline gene editing, meaning editing genes that can be passed on to future generations. Opens in a new window nla.gov.au Prohibition of Human Cloning for Reproduction Act 2002, Australia
United States:
- Food and Drug Administration (FDA): The FDA regulates gene-edited food and medical products. Their approach considers the final product and associated risks, not necessarily the specific editing technique used. Opens in a new window www.fda.gov Food and Drug Administration (FDA), United States
- United States Department of Agriculture (USDA): The USDA oversees gene-edited plants and animals for agriculture. Similar to the FDA, their focus is on the final product’s safety and environmental impact. Opens in a new window socialprotection.org United States Department of Agriculture (USDA)
United Kingdom:
- Human Fertilisation and Embryology Act 2008: This Act prohibits human germline gene editing and sets regulations for research involving human embryos. Opens in a new window ukhumanrightsblog.com Human Fertilisation and Embryology Act 2008, United Kingdom
- Genetically Modified Organisms (GMO) regulations: The UK follows EU regulations for GMOs, which may apply to some gene-edited products depending on the editing technique and final product characteristics.
European Union:
- Directive 2001/18/EC on the Deliberate Release of Genetically Modified Organisms into the Environment: This directive regulates the release of GMOs, including some gene-edited organisms, into the environment. Opens in a new window www.reading.ac.uk Directive 2001/18/EC on the Deliberate Release of Genetically Modified Organisms into the Environment, European Union
- Regulation (EU) 2015/2121 on novel foods: This regulation sets requirements for placing novel foods, including some gene-edited foods, on the EU market.
- Proposed regulation on new genomic techniques: The EU Commission has proposed a new regulation specifically addressing new genomic techniques (NGTs), including some gene editing techniques. This regulation is currently under discussion
Canada:
- Canadian Biosafety Act: This Act regulates the use of genetically modified organisms (GMOs), including some gene-edited organisms. Opens in a new window www.canada.ca Canadian Biosafety Act, Canada
- Food and Drugs Act: This Act regulates food and drugs, including gene-edited products intended for human consumption.
It’s important to note that these are just brief summaries, and the specific regulations can be complex and nuanced. For more detailed information, it’s best to consult with relevant regulatory agencies or legal experts in each country.
All good so far but here’s the issue. There are virtually unlimited amounts of money on the table, so it’s logical to assume many will want a slice of that. Many countries have no legislative framework covering these developments, and these countries will attract corporations and individuals who wish to profit from the technology. Often in these countries there are few barriers, low costs, cheap land and labor, and corrupt governments. The “product” is tiny, easily smuggled and disguised, and often extremely valuable.
It is reasonable to assume that scenarios where, for example, seeds with fast growth and high yield are patented, made sterile (so farmers need to buy in new seed every cycle), and heavily promoted to the detriment of established species and variants. If you promise fast growth and high yield the financial aspect overcomes any issues with adoption. If there is a problem it usually arises years later, and often by then the corporation has taken steps to avoid liability claims, preserve their accumulated assets, and avoid tax. The tetra-ethyl lead and CFC issues (both brought to us by the U.S. chemist Thomas Midgely) are prime examples. Lead poisoning in children was blamed on “lead” paint and pencils – they knew the bulk of it was coming from leaded petrol, but the oil and transport industries had enormous power, so with the help of science and the media they promoted the lie to avoid liability. Eventually the truth comes out, but usually the culprits are long gone, along with the profits. The death toll is of no concern if the profit is there.
I’m sure most of you will have thought of other examples to illustrate what I have just said. The larger questions around ethics, morality, greed, deceit, and motivation remain unaddressed and unanswered; indeed we avoid them where possible. Does this make us unethical, immoral, greedy and deceitful? Most of us would reject that assertion of course, but it begs the question. Why do we tolerate this?
Feeds