GloFish are genetically engineered fluorescent fish that were originally created by scientists to detect environmental toxins. They are now sold in the United States as pets. However, the legality of GloFish has been controversial, with regulations varying between different states and countries.
What are GloFish?
GloFish are a brand of fluorescent fish that were first developed in 1999 by scientists at the National University of Singapore. They were originally created by inserting genes from fluorescent jellyfish and sea corals into zebrafish embryos. This genetic engineering allows the fish to produce bright red, green, orange, blue, and purple fluorescent colors.
The original purpose of creating GloFish was to monitor pollution and toxins in waterways. The fluorescent fish would light up when exposed to toxins, acting as a living indicator of environmental hazards. However, in 2003 a US company purchased the rights to market GloFish as pets. Since then, they have become one of the most popular genetically modified organisms sold.
There are currently five varieties of GloFish for sale as aquarium fish: Starfire Red®, Electric Green®, Sunburst Orange®, Cosmic Blue®, and Galactic Purple®. They are based on zebrafish, black skirt tetras, and tiger barbs that have been genetically modified with fluorescent proteins from sea anemones and coral.
Are GloFish legal in the United States?
In the United States, GloFish are legal for sale and possession in every state except California. However, they remain banned in California under the state’s Fish and Game Code Regulations. The US Food and Drug Administration (FDA) determined in 2003 that GloFish pose no environmental or health risks compared to regular fish.
The FDA issued a statement declaring GloFish safe for interstate commerce and cleared them for sale. According to the FDA, there were no differences in food safety between GloFish and their unmodified counterparts. Additionally, the FDA found the fluorescent proteins derived from marine organisms to be safe and not to pose any allergenic risks.
Following FDA approval, most US states allowed the commercial sale of GloFish. To date, 49 states and the District of Columbia permit the buying and keeping of GloFish as pets. The only state where GloFish remain illegal is California, which passed legislation banning them over concerns about potential environmental impacts if released.
Why are GloFish illegal in California?
California banned the importation, possession, or sale of GloFish through Title 14, Section 671 of the California Code of Regulations. This regulation, passed in 2002, prohibits live fish, live freshwater fish, or transgenic fish species from entering California waters without a permit issued by the California Department of Fish and Wildlife.
The concerns cited by California lawmakers were primarily ecological. There were worries that if GloFish were released into natural waterways, they could pass on their engineered fluorescent genes and disrupt local ecosystems. Critics argued this could impact native fish populations and lead to unknown environmental damage.
Additionally, the state of California sought to take a precautionary approach until more research could definitively show that GloFish are safe for ecosystems. The ban remains in place today due to insufficient data available to adequately assess the environmental risks.
What federal laws apply to GloFish in the US?
There are two main federal laws that regulate GloFish and other genetically engineered animals in the United States:
- The Federal Food, Drug, and Cosmetic Act – Gives the FDA regulatory authority over genetically engineered animals sold for human consumption or intended to go into the human food supply.
- The Toxic Substances Control Act – Requires regulatory approval from the EPA before genetically modified fish can be commercialized in the US. GloFish were exempted from this act.
The FDA approval process for GloFish determined that they are safe for humans, non-toxic, and not materially different from non-GE fish in food safety. The FDA also concluded an environmental assessment was not needed under the National Environmental Policy Act.
Meanwhile, the EPA gave GloFish a loophole exemption from its TSCA regulations. The EPA does not currently consider GloFish to be “new species” subject to regulation as long as they are not released into the environment. So while technically subject to TSCA, EPA exemptions allowed GloFish to bypass oversight.
Could the regulatory status of GloFish change?
It’s possible the regulatory status of GloFish could be revised in the future. Some environmental and consumer groups continue to advocate for more stringent oversight and regulation when it comes to genetically engineered pets and animals intended for human consumption.
Potential regulatory changes could include:
- Required EPA review under TSCA before new varieties of GloFish could be commercially sold as pets.
- Stricter FDA requirements for demonstrating food safety/nutrition for GloFish sold for human food.
- Assessment of environmental impact risks prior to approval of new genetically engineered animals.
- Review of state laws regarding possession of GloFish as pets.
However, significant changes to the regulatory status of GloFish are not expected in the short-term since neither the FDA nor EPA view them as posing significant public health or environmental threats at this time.
Are GloFish legal in Canada?
No, GloFish are currently banned in Canada. Health Canada, the department responsible for regulating products and food, has not approved any genetically engineered glowing fish for use as pets or for human consumption.
Under the Canadian Environmental Protection Act (CEPA), a New Substances Notification must be submitted and approved before the manufacture, import, or sale of any new genetically engineered fish like GloFish. To date, no authorization has been granted.
In 2013, Health Canada issued a directive prohibiting the commercialization, import and sale of GloFish in Canada. They cited concerns over the unknown environmental impacts should the genetically modified fish escape into Canadian ecosystems.
The ban remains in place today. Anyone caught importing or selling GloFish in Canada can face penalties under CEPA including fines up to $300,000 CAD and/or imprisonment.
Arguments for legalizing GloFish in Canada
Those in favor of legalization make the following arguments:
- GloFish pose minimal environmental risk since they are well-established as pets in the US.
- No adverse eco-impacts have been reported from GloFish accidental release in the US.
- Prevents illegal importation and black-market trade in GloFish.
- FDA and EPA found GloFish safe in the US.
- Consumer freedom – Canadians are denied access to popular product.
Arguments against legalizing GloFish in Canada
Those opposed to legalizing GloFish in Canada argue:
- Unknown ecological impacts if released and able to breed in Canadian waters.
- GloFish could outcompete native species for resources.
- Insufficient data to guarantee no environmental harms.
- Precautionary principle dictates against allowing their sale.
- Ethical concerns about genetically engineered pets.
- Directive 2001/18/EC – Covers the release of GMOs into the environment.
- Regulation (EC) No 1829/2003 – Covers GM food and feed.
- Directive 2009/41/EC – Covers contained use of genetically modified microorganisms.
- Fines up to €200,000 in Croatia.
- Up to 2 years imprisonment in Czech Republic.
- Fines up to £5 million in the UK.
- Up to 3 years jail time in France.
- Cartagena Act – Implements the Cartagena Protocol on Biosafety governing international GM trade. Restricts import of GMOs like GloFish without a risk assessment.
- Law Concerning the Conservation and Sustainable Use of Biological Diversity Through Regulations on the Use of Living Modified Organisms – Requires government approval for domestic use of GMOs.
Given the conflicting viewpoints, the approval status of GloFish remains a source of debate between regulatory officials, scientists, and the public.
Is it legal to sell GloFish in the UK?
No, it is currently illegal to sell GloFish in the United Kingdom. GloFish have not been approved for importation or commercial sale by UK authorities over environmental concerns about genetic pollution.
Under the Environmental Protection Act 1990, the introduction of genetically modified organisms like GloFish requires consent from the Secretary of State. Government officials have not given consent for GloFish based on a lack of evidence about ecological impacts.
Additionally, the Genetically Modified Animals (England) Regulations 2002 made it illegal to keep, breed, or release genetically modified fish without a license. To date, no licenses have been issued that would permit GloFish.
There are also restrictions from the EU. Although the UK is no longer part of the EU, its policies still influence laws on GMOs. The EU takes a cautionary stance and limits imports of genetically engineered animals until risks are assessed.
While not explicitly banned under UK legislation, government policy means GloFish cannot legally be imported from the US and other countries or sold by UK pet shops or retailers due to lack of approval.
Could GloFish regulations change post-Brexit?
Now that the UK has left the European Union, there is potential for gene-edited animals like GloFish to be treated differently. The UK could diverge from EU stances on GMO restrictions in the future.
However, significant policy changes are unlikely in the near term. UK scientists and conservation groups largely echo EU concerns about potential environmental risks. And import approval would still be required under national laws.
The UK Centre for Ecology and Hydrology concludes “considerable uncertainties” remain over the impacts of releasing GMOs. Government approval would necessitate thorough risk assessment first. So while theoretically possible to legalize GloFish in the UK after Brexit, existing environmental regulations suggest they will remain banned for now.
Are GloFish legal in the EU?
No, GloFish are banned in all European Union member countries under EU legislation regulating genetically modified organisms (GMOs). There is a complete prohibition on their import, sale, and propagation.
The key EU laws imposing restrictions on GloFish are:
To gain EU approval for commercial sale, GloFish would have to go through a long authorization process. This requires a comprehensive environmental risk assessment, scientific review, and regulatory approval from an EU committee. But this approval has never been granted for any genetically modified ornamental fish.
The European Commission takes a cautious approach to GMOs and has not approved import of GloFish over concerns about unknown ecological effects if accidentally released. No EU country permits the sale of these genetically engineered fluorescent fish.
Punishments for GloFish violations
Fines or criminal penalties can result from unlawfully importing, transporting, or releasing unauthorized GMOs like GloFish in Europe. Punishment varies by country but can include:
There have been seizures of illegally smuggled GloFish entering the EU through the Netherlands, Lithuania, and the UK. Going forward, EU member states are increasing checks on ornamental fish imports to prevent GMO violations.
Is it legal to own GloFish in Australia?
No, it is currently illegal to import, sell, or keep GloFish as pets in Australia. The country has banned GloFish over concerns about potential impacts to native wildlife if the genetically modified fish are released.
Under the Gene Technology Act 2000, all genetically modified organisms must be approved by the Office of the Gene Technology Regulator before use in Australia. Neither GloFish nor any other genetically engineered ornamental fish have received approval.
Additionally, Australia’s import conditions prohibit genetically modified live fish from entering the country without a permit. Permits are only granted if a biosafety risk assessment shows minimal threats to human health and the environment.
Anyone caught importing, breeding, or selling unapproved GMOs for commercial purposes can face civil penalties up to AU$220,000 or criminal fines up to AU$1.1 million. There can also be up to five years imprisonment for criminal offenses.
Possible route to legalization
One potential path that could lead to legalization is if GloFish undergo a full risk assessment by the OGTR and are deemed low biosecurity threats. But the assessment process requires data on reproductive capabilities, survivability in the wild, and other factors. Past applications for GM salmon approval failed due to data deficiencies.
If eventually approved, GloFish would likely be subject to restrictions similar to GM crops. There would be requirements about containment, labeling, and protecting the environment. But actual legalization remains unlikely without more safety studies specifically tailored to Australian ecosystems.
Are GloFish legal in Japan?
No, GloFish are prohibited in Japan under the country’s strict laws regulating genetically modified products. While some GM crops have been approved, Japan has not permitted any genetically engineered animals for food or ornamental purposes to date.
The two key regulations restricting GloFish in Japan are:
To legalize GloFish, extensive food/environmental safety studies specific to Japan would need to be completed. The government would have to determine they pose minimal risks before allowing imports or sales within the country. But Japan has taken a highly precautionary approach to GM animals so far.
Some Japanese retailers allegedly sold banned GM ornamental carp in the early 2000s before the country strengthened GMO regulations. But today, the legal penalties and risk of lost consumer trust deter retailers from attempting to sell prohibited genetically engineered animals like GloFish.
Conclusion
In summary, GloFish remain banned for sale and possession in many parts of the world over concerns about potential environmental impacts from genetic pollution. They are only legal in the United States, with the exception of restricted sales in California.
The approval status of GloFish remains controversial globally. While approved by the FDA in the US, other countries argue there is insufficient safety data to allow their importation and sale. Unless further environmental risk studies provide adequate assurances, genetically modified fluorescent fish will likely continue facing bans or sales restrictions worldwide.
