The regulation of genetic engineering varies widely by country. Countries such as the United States, Canada, Lebanon and Egypt use substantial equivalence as the starting point when assessing safety, while many countries such as those in the European Union, Brazil and China authorize GMO cultivation on a case-by-case basis. Many countries allow the import of GM food with authorization, but either do not allow its cultivation (Russia, Norway, Israel) or have provisions for cultivation, but no GM products are yet produced (Japan, South Korea). Most countries that do not allow for GMO cultivation do permit research.
One of the key issues concerning regulators is whether GM
products should be labeled. Labeling of GMO products in the marketplace
is required in 64 countries.
Labeling can be mandatory up to a threshold GM content level (which
varies between countries) or voluntary. A study investigating voluntary
labeling in South Africa found that 31% of products labeled as GMO-free
had a GM content above 1.0%. In Canada and the USA labeling of GM food is voluntary, while in Europe all food (including processed food) or feed which contains greater than 0.9% of approved GMOs must be labelled.
There is a scientific consensus that currently available food derived from GM crops poses no greater risk to human health than conventional food, but that each GM food needs to be tested on a case-by-case basis before introduction. Nonetheless, members of the public are much less likely than scientists to perceive GM foods as safe. The legal and regulatory status of GM foods varies by country, with some nations banning or restricting them, and others permitting them with widely differing degrees of regulation.
There is no evidence to support the idea that the consumption of approved GM food has a detrimental effect on human health. Some scientists and advocacy groups, such as Greenpeace and World Wildlife Fund, have however called for additional and more rigorous testing for GM food.
There is a scientific consensus that currently available food derived from GM crops poses no greater risk to human health than conventional food, but that each GM food needs to be tested on a case-by-case basis before introduction. Nonetheless, members of the public are much less likely than scientists to perceive GM foods as safe. The legal and regulatory status of GM foods varies by country, with some nations banning or restricting them, and others permitting them with widely differing degrees of regulation.
There is no evidence to support the idea that the consumption of approved GM food has a detrimental effect on human health. Some scientists and advocacy groups, such as Greenpeace and World Wildlife Fund, have however called for additional and more rigorous testing for GM food.
History
The development of a regulatory framework concerning genetic engineering began in 1975, at Asilomar, California. The first use of Recombinant DNA (rDNA) technology had just been successfully accomplished by Stanley Cohen and Herbert Boyer
two years previously and the scientific community recognized that as
well as benefits this technology could also pose some risks. The Asilomar meeting
recommended a set of guidelines regarding the cautious use of
recombinant technology and any products resulting from that technology. The Asilomar recommendations were voluntary, but in 1976 the US National Institute of Health (NIH) formed a rDNA advisory committee. This was followed by other regulatory offices (the United States Department of Agriculture (USDA), Environmental Protection Agency (EPA) and Food and Drug Administration (FDA)), effectively making all rDNA research tightly regulated in the USA.
In 1982 the Organisation for Economic Co-operation and Development
(OECD) released a report into the potential hazards of releasing
genetically modified organisms into the environment as the first
transgenic plants were being developed. As the technology improved and genetically organisms moved from model organisms to potential commercial products the USA established a committee at the Office of Science and Technology (OSTP) to develop mechanisms to regulate the developing technology. In 1986 the OSTP assigned regulatory approval of genetically modified plants in the US to the USDA, FDA and EPA.
The basic concepts for the safety assessment of foods derived
from GMOs have been developed in close collaboration under the auspices
of the OECD, the World Health Organization (WHO) and Food and Agriculture Organization
(FAO). A first joint FAO/WHO consultation in 1990 resulted in the
publication of the report ‘Strategies for Assessing the Safety of Foods
Produced by Biotechnology’ in 1991.
Building on that, an international consensus was reached by the OECD’s
Group of National Experts on Safety in Biotechnology, for assessing
biotechnology in general, including field testing GM crops.
That Group met again in Bergen, Norway in 1992 and reached consensus
on principles for evaluating the safety of GM food; its report, ‘The
safety evaluation of foods derived by modern technology – concepts and
principles’ was published in 1993.
That report recommends conducting the safety assessment of a GM food on
a case-by-case basis through comparison to an existing food with a long
history of safe use. This basic concept has been refined in subsequent
workshops and consultations organized by the OECD, WHO, and FAO, and the
OECD in particular has taken the lead in acquiring data and developing
standards for conventional foods to be used in assessing substantial
equivalence.
The Cartagena Protocol on Biosafety was adopted on 29 January 2000 and entered into force on 11 September 2003.
It is an international treaty that governs the transfer, handling, and
use of genetically modified (GM) organisms. It is focused on movement of
GMOs between countries and has been called a de facto trade agreement.
One hundred and fifty-seven countries are members of the Protocol and
many use it as a reference point for their own regulations.
Also in 2003 the Codex Alimentarius Commission of the FAO/WHO adopted a
set of "Principles and Guidelines on foods derived from biotechnology"
to help countries coordinate and standardize regulation of GM food to
help ensure public safety and facilitate international trade. and updated its guidelines for import and export of food in 2004.
The European Union first introduced laws requiring GMO's to be labelled in 1997.
In 2013, Connecticut became the first state to enact a labeling law in
the USA, although it would not take effect until other states followed
suit.
In the laboratory
Institutions
that conduct certain types of scientific research must obtain
permission from government authorities and ethical committees before
they conduct any experiments. Universities and research institutes
generally have a special committee that is responsible for approving any
experiments that involve genetic engineering. Many experiments also need permission from a national regulatory group. Most countries have exempt dealings for genetically modified organisms (GMOs) that only pose a low risk. These include systems using standard laboratory strains as the hosts, recombinant DNA that does not code for a vertebrate toxin or is not derived from a micro-organism
that can cause disease in humans. Exempt dealings usually do not
require approval from the national regulator. GMOs that pose a low risk
if certain management practices are complied with are classified as
notifiable low risk dealings. The final classification is for any uses
of GMOs that do not meet the previous criteria. These are known as
licensed dealings and include cloning
any genes that code for vertebrate toxins or using hosts that are
capable of causing disease in humans. Licensed dealings require the
approval of the national regulator.
Work with exempt GMOs do not need to be carried out in certified
laboratories. All others must be contained in a Physical Containment
level 1 (PC1) or Physical Containment level 2 (PC2) laboratories.
Laboratory work with GMOs classified as low risk, which include knockout mice, are carried out in PC1 lab. This is the case for modifications that do not confer an advantage
to the animal or doesn't secrete any infectious agents. If a laboratory
strain that is used isn't covered by exempt dealings or the inserted
DNA could code for a pathogenic gene, it must be carried out in a PC2
laboratory.
Release
Europe and United States
The approaches taken by governments to assess and manage the risks associated with the use of genetic engineering
technology and the development and release of GMOs vary from country to
country, with some of the most marked differences occurring between the
United States and Europe. The U.S. regulatory policy is governed by the
Coordinated Framework for Regulation of Biotechnology
The policy has three tenets: "(1) U.S. policy would focus on the
product of genetic modification (GM) techniques, not the process itself,
(2) only regulation grounded in verifiable scientific risks would be
tolerated, and (3) GM products are on a continuum with existing products
and, therefore, existing statutes are sufficient to review the
products." European Union by contrast enacted regulatory laws in 2003 that provided possibly the most stringent GMO regulations in the world. All GMOs, along with irradiated food, are considered "new food" and subject to extensive, case-by-case, science-based food evaluation by the European Food Safety Authority
(EFSA). The criteria for authorization fall in four broad categories:
"safety," "freedom of choice," "labeling," and "traceability."
The European Union has heavily contrasted its regulations and
restrictions regarding genetic engineering compared to those of the
United States. The European Parliament's Committee on the Environmental,
Public Health, and Consumer Protection pushed forward and adopted a
"safety first" principle regarding the case of GMOs, calling for any
negative health consequences from GMOs to be held liable. On the other
hand, the United States still takes on a less hands-on approach to the
regulation of GMOs, with the FDA and USDA only looking over pesticide
and plant health facets of GMOs.
Despite the overall global increase in the production in GMOs, the
European Union has still stalled GMOs fully integrating into its food
supply. This has definitely affected various countries, including the United States, when trading with the EU.
However, although the European Union has had relatively strict
regulations regarding the genetically modified food, Europe is now
allowing newer versions of modified maize and other agricultural
produce. Also, the level of GMO acceptance in the European Union varies
across its countries with Spain and Portugal being more permissive of
GMOs than France and the Nordic population.
One notable exception however is Sweden. In this country, the
government has declared that the GMO definition (according to Directive
2001/18/EC)
stipulates that foreign DNA needs to be present in an organism for it
to qualify as a genetically modified organisms. Organisms that thus have
the foreign DNA removed (for example via selective breeding) do not qualify as GMO's, even if gene editing has thus been used to make the organism.
For a genetically modified organism to be approved for release in the U.S., it must be assessed under the Plant Protection Act by the Animal and Plant Health Inspection Service
(APHIS) agency within the USDA and may also be assessed by the FDA and
the EPA, depending on the intended use of the organism. The USDA
evaluate the plants potential to become weeds, the FDA reviews plants
that could enter or alter the food supply, and the EPA regulates genetically modified plants with pesticide properties, as well as agrochemical residues. In Europe the EFSA reports to the European Commission
who then draft a proposal for granting or refusing the authorisation.
This proposal is submitted to the Section on GM Food and Feed of the
Standing Committee on the Food Chain and Animal Health and if accepted
it will be adopted by the EC or passed on to the Council of Agricultural Ministers.
Once in the Council it has three months to reach a qualified majority
for or against the proposal, if no majority is reached the proposal is
passed back to the EC who will then adopt the proposal.
However, even after authorization, individual EU member states can
ban individual varieties under a 'safeguard clause' if there are
"justifiable reasons" that the variety may cause harm to humans or the
environment. The member state must then supply sufficient evidence that
this is the case.
The Commission is obliged to investigate these cases and either
overturn the original registrations or request the country to withdraw
its temporary restriction.
Other countries
The level of regulation in other countries lies in between Europe and the United States. Common Market for Eastern and Southern Africa
(COMASA) is responsible for assessing the safety of GMOs in most of
Africa, although the final decision lies with each individual country. India and China are the two largest producers of genetically modified products in Asia. The Office of Agricultural Genetic Engineering Biosafety Administration (OAGEBA) is responsible for regulation in China,
while in India it is the Institutional Biosafety Committee (IBSC),
Review Committee on Genetic Manipulation (RCGM) and Genetic Engineering
Approval Committee (GEAC). Brazil and Argentina are the 2nd and 3rd largest producers of GM food.
In Argentine assessment of GM products for release is provided by the
National Agricultural Biotechnology Advisory Committee (environmental
impact), the National Service of Health and Agrifood Quality (food
safety) and the National Agribusiness Direction (effect on trade), with
the final decision made by the Secretariat of Agriculture, Livestock,
Fishery and Food.
In Brazil the National Biosafety Technical Commission is responsible
for assessing environmental and food safety and prepares guidelines for
transport, importation and field experiments involving GM products,
while the Council of Ministers evaluates the commercial and economical
issues with release. Health Canada and the Canadian Food Inspection Agency are responsible for evaluating the safety and nutritional value of genetically modified foods released in Canada. License applications for the release of all genetically modified organisms in Australia is overseen by the Office of the Gene Technology Regulator, while regulation is provided by the Therapeutic Goods Administration for GM medicines or Food Standards Australia New Zealand
for GM food. The individual state governments can then assess the
impact of release on markets and trade and apply further legislation to
control approved genetically modified products.
| Region | Regulator/s | Notes |
|---|---|---|
| USA | USDA, FDA and EPA |
|
| Europe | European Food Safety Authority |
|
| Canada | Health Canada and the Canadian Food Inspection Agency | Based on whether a product has novel features regardless of method of origin |
| Africa | Common Market for Eastern and Southern Africa | Final decision lies with each individual country. |
| China | Office of Agricultural Genetic Engineering Biosafety Administration |
|
| India | Institutional Biosafety Committee, Review Committee on Genetic Manipulation and Genetic Engineering Approval Committee |
|
| Argentina | National Agricultural Biotechnology Advisory Committee (environmental impact), the National Service of Health and Agrifood Quality (food safety) and the National Agribusiness Direction (effect on trade) | Final decision made by the Secretariat of Agriculture, Livestock, Fishery and Food. |
| Brazil | National Biosafety Technical Commission (environmental and food safety) and the Council of Ministers (commercial and economical issues) |
|
| Australia | Office of the Gene Technology Regulator (overseas all), Therapeutic Goods Administration (GM medicines) and Food Standards Australia New Zealand (GM food). | The individual state governments can then assess the impact of release on markets and trade and apply further legislation to control approved genetically modified products. |
Labeling
One
of the key issues concerning regulators is whether GM products should be
labeled. Labeling can be mandatory up to a threshold GM content level
(which varies between countries) or voluntary. A study investigating
voluntary labeling in South Africa found that 31% of products labeled as
GMO-free had a GM content above 1.0%. In Canada and the United States labeling of GM food is voluntary, while in Europe all food (including processed food) or feed which contains greater than 0.9% of approved GMOs must be labelled. In the US state of Oregon., voters rejected Measure 27, which would have required labeling of all genetically modified foods.
Japan, Malaysia, New Zealand, and Australia require labeling so
consumers can exercise choice between foods that have genetically
modified, conventional or organic origins.
Trade
The Cartagena Protocol sets the requirements for the international
trade of GMO's between countries that are signatories to it. Any
shipments contain geneticially modified organisms that are intended to
be used as feed, food or for processing must be identified and a list of
the transgenic events be available.
Substantial equivalence
"Substantial equivalence" is a starting point for the safety
assessment for GM foods that is widely used by national and
international agencies—including the Canadian Food Inspection Agency,
Japan's Ministry of Health and Welfare and the U.S. Food and Drug
Administration, the United Nation’s Food and Agriculture Organization,
the World Health Organization and the OECD.
A quote from FAO, one of the agencies that developed the concept,
is useful for defining it: "Substantial equivalence embodies the
concept that if a new food or food component is found to be
substantially equivalent to an existing food or food component, it can
be treated in the same manner with respect to safety (i.e., the food or
food component can be concluded to be as safe as the conventional food
or food component)".
The concept of substantial equivalence also recognises the fact that
existing foods often contain toxic components (usually called
antinutrients) and are still able to be consumed safely—in practice
there is some tolerable chemical risk taken with all foods, so a
comparative method for assessing safety needs to be adopted. For
instance, potatoes and tomatoes can contain toxic levels of
respectively, solanine and alpha-tomatine alkaloids.
To decide if a modified product is substantially equivalent, the
product is tested by the manufacturer for unexpected changes in a
limited set of components such as toxins, nutrients, or allergens that
are present in the unmodified food. The manufacturer's data is then
assessed by a regulatory agency, such as the U.S. Food and Drug Administration.
That data, along with data on the genetic modification itself and
resulting proteins (or lack of protein), is submitted to regulators. If
regulators determine that the submitted data show no significant
difference between the modified and unmodified products, then the
regulators will generally not require further food safety testing.
However, if the product has no natural equivalent, or shows significant
differences from the unmodified food, or for other reasons that
regulators may have (for instance, if a gene produces a protein that had
not been a food component before), the regulators may require that
further safety testing be carried out.
A 2003 review in Trends in Biotechnology identified seven main parts of a standard safety test:
- Study of the introduced DNA and the new proteins or metabolites that it produces;
- Analysis of the chemical composition of the relevant plant parts, measuring nutrients, anti-nutrients as well as any natural toxins or known allergens;
- Assess the risk of gene transfer from the food to microorganisms in the human gut;
- Study the possibility that any new components in the food might be allergens;
- Estimate how much of a normal diet the food will make up;
- Estimate any toxicological or nutritional problems revealed by this data in light of data on equivalent foods;
- Additional animal toxicity tests if there is the possibility that the food might pose a risk.
There has been discussion about applying new biochemical
concepts and methods in evaluating substantial equivalence, such as
metabolic profiling and protein profiling. These concepts refer,
respectively, to the complete measured biochemical spectrum (total
fingerprint) of compounds (metabolites) or of proteins present in a food
or crop. The goal would be to compare overall the biochemical profile
of a new food to an existing food to see if the new food's profile falls
within the range of natural variation already exhibited by the profile
of existing foods or crops. However, these techniques are not
considered sufficiently evaluated, and standards have not yet been
developed, to apply them.
Genetically modified animals
Transgenic animals
have genetically modified DNA. Animals are different from plants in a
variety of ways—biology, life cycles, or potential environmental
impacts.
GM plants and animals were being developed around the same time, but
due to the complexity of their biology and inefficiency with laboratory
equipment use, their appearance in the market was delayed.
There are six categories that genetically engineered (GE) animals are approved for:
- Use for biomedical research. Smaller mammalians can be used as models in scientific research to represent other mammals.
- Used to develop innovative kinds of fish for environmental monitoring.
- Used to produce proteins that humans lack. This can be for therapeutic use, for example, treatment of diseases in other mammals.
- Use for investigating and finding cures for diseases. Can be used for introducing disease resistance in GM breeds.
- Used to create manufacturing products for industry use.
- Used for improving food quality.
