There is a different approach to the GMO Research,Testing, Approval, Regulation, and Labelling process In different countries.
We’ve outlined some of those key differences below.
Summary – How GMO Research, Testing, Approval, Regulation & Labelling Differs In Different Countries
- There’s a difference between growing GMO foods and crops (which most countries are restrictive on), and importing GE ingredients (which some countries are more lenient on)
- Some countries have a complete ban on both growing and importing GMO/GE foods – such as Russia
- The United States is much less restrictive than any other country when it comes to GMO food and crops
- The regulations and food labelling in the US is much less restrictive than anywhere else in the world
- The United States and Europe are often compared as having vastly different approaches to GMO regulation, testing and approval when it comes to growing GMO crops and food
- Some of the opposition to GMO foods and crops say that in the United States, when it comes to the FDA and approving food for human consumption – voluntary testing, no requirement for GMO food labelling and the standards for testing/approval (‘substantial equivalence’, and ‘generally recognised as safe) are all concerning parts of the approval and regulation process. How close the FDA might be to the GMO companies is also a concern for some GMO opposition parties, because there might be a conflict of interest to get GMOs approved
- GMO companies dispute this and say in reality they end up providing many tests to the FDA, costing millions of dollars, and that the approval process for GMO crops and foods takes many years
- Currently, there is a scientific consensus (from around 3000 different studies) that GMO foods and crops present no more risk to human health than conventional foods and crops, but each GM food/crop must be assessed on a case by case basis
- Some people question the research – citing that the independent studies are mostly funded by GMO companies, and that the research process is restrictive for researches and there’s a chance their complete findings may be edited out of the final published study
- GMO supporters dispute this and say that negative GMO research is cherry picked from a small number of studies, research is not restrictive, and that GMO companies have to provide funding because both public and private funding from other sources can be hard to obtain for independent researchers
- You can read more about both sides of the GMO research debate in this guide
Regulation & Testing Of GMO Food & Crops In The United States
In the United States, genetically modified crops are regulated by three different agencies:
- The Department of Agriculture (USDA) – regulates field testing of GM crops for research.
- The Environmental Protection Agency (EPA) – regulates plants with pest-resistant properties.
- And the Food and Drug Administration (FDA) – regulates any GM crops that are eaten by humans or animals.
There’s no specific law that regulates genetically modified foods. Instead, back in 1997 the agency created a voluntary “consultation” process for companies that want to sell new GM crops.
The companies conduct a safety assessment that identifies the novel genetic traits and determines whether any of the new material could be toxic or allergenic.
FDA scientists can ask for additional tests and data as needed. To date, some 96 crops have gone through this process.
Critics tend to focus on the fact that this safety assessment is voluntary — there are no laws requiring specific tests. Biotech companies often retort that it’s not that “voluntary” in practice. They end up carrying out a large number of tests and give the FDA whatever data the agency asks for. (After all, the FDA does have the authority to require pre-market review for any substances not generally recognized as safe.)
The regulation of GMOs is based on the principle of “substantial equivalence”, meaning that the nutritional content of the GE crop and the non-GE crop that it originated from is the same. … [in terms of past studies of] crops generated by transgenesis (the method used to make GMOs) vs crops generated by traditional cross breeding and mutagenesis… the transgenic crops had far fewer unintended consequences than the crops generated by traditional breeding methods.
What remains to be demonstrated is that the protein introduced poses no greater risk to human health than non-GE crops, which is why studies on allergenicity and animal feeding studies are performed.
So “why don’t we do clinical trials on GMOs the same way we do for drugs?” Drugs are designed to cause a change in the human body: that’s the whole point behind them. Since drugs are altering something in humans, it’s important to know the side-effects that they may cause and whether or not they’re causing the anticipated effect (i.e. is it better than placebo).
In contrast, GMOs are designed to be equivalent to their non-GE counterparts: they aren’t drugs or nutritional supplements. GE crops which ARE designed to impact human health, such as vitamin-A enriched rice, should be tested in humans to determine if the desired outcome is achieved (i.e that the rice actually delivers vitamin-A to the body).
But such studies are not the same as looking for unknown long-term effects.
- For a genetically modified organism to be approved for release it is assessed by the USDA, the FDA and the EPA.
- USDA evaluates the plant’s potential to become weeds
- the FDA reviews plants that could enter or alter the food supply
- the EPA regulates the genetically modified plants with pesticide properties
- Most developed genetically modified plants are reviewed by at least two of the agencies, with many subject to all three.
- Final approval can still be denied by individual counties within each state.
- In 2004, Mendocino County, California became the first and only county to impose a ban on the “Propagation, Cultivation, Raising, and Growing of Genetically Modified Organisms”, the measure passing with a 57% majority.
US Department Of Agriculture
- The USDA is responsible for approving field trials of GM plants under either the notification or permit procedures.
- The notification procedure is a streamlined process for the simplest or most familiar genetically engineered plants that meet six criteria (is not a noxious weed, the function of the genetic material is known and characterized, stable integration, no significant risk of creating new viruses and that no animal or human pathogen sequences are present).
- Most field trials are approved under the notification procedure. T
- he permit procedure is much more elaborate and is required for all genetically engineered organisms that do not meet the notification requirements or any plant-made pharmaceuticals or plant-made industrial products.
Food & Drug Administration
- The FDA is responsible for the safety and security of human and animal food and drugs, including any that are genetically modified…
- When evaluating new GM foods or feed the FDA looks for the presence of any new or altered allergens and toxicants and examines changes in the levels of nutritional and anti-nutritional substances.
- Food and feed that is identical or nearly identical in composition to current products is deemed to be substantially equivalent and is not required to undergo review by the FDA.
- The FDA has been criticized for using substantial equivalence, with a major accusation being that FDA review is essentially voluntary as almost all GM products are substantially equivalent.
- However, all GM food and feed currently on the US market (as of 2008) have undergone a FDA consultation, where the developer submits the compositional data and FDA scientist compare it to regular food and feed…
- The FDA consultation focuses on whether the new food or feed contains any new allergens or toxic substances and whether the nutritional components of the food or feed have increased or decreased.
- The developer submits documentation to the FDA describing the food or feed and a FDA assigned caseworker can then request additional information on expected dietary exposure, in particular if any risk groups (children, elderly etc.) might be exposed…
- The FDA consultation process is relatively (when compared to the other agencies regulating GM) informal and they do not approve new GM products. Instead they issue a memo stating whether the new food is the same as or different from the non-modified variety…
- The Center for Veterinary Medicine of the FDA regulates genetically modified animals in consultation with Centers at the FDA responsible for regulating pharmaceuticals or other medical products derived from biopharm animals.
- The FDA also has extra guidelines that apply to genetically modified animals that will be used in the manufacturing and testing of therapeutic products and xenotransplantation.
- The FDA guidance documents do not establish legally binding laws and are viewed as recommendations, unless specific regulatory or statutory requirements are cited. Any relevant federal, State, or local laws and regulations must also be adhered to.
Environmental Protection Agency
- The EPA regulates substances with pesticide characteristics, looking at potential threats to human health or the environment. They claim not to regulate the genetically modified plants, but the pesticides produced by the plants or properties that change the usage of applied pesticides . This includes; plants engineered to produce resistance to herbicides (e.g. Roundup Ready), plants that produce their own pesticides (e.g. BT) and virus resistant plants…
- The EPA assesses data concerning the characterisation of the end-product of the engineered organism (presently all plants evaluated produce proteins), as well as data on mammalian toxicity, effects on non-target organisms and environmental metabolism.
- For Bt products the producer must also supply an insect resistance management program.
- For herbicide resistant plants the EPA co-ordinates with the USDA and FDA, but does not regulate the plant itself. Instead it regulates the herbicide and its use on the new cultivar. The EPA examines the construct used to transform the plant and the biology of recipient plant.
- The sequence of the resulting protein must be described, expression pattern and intensity verified and any modifications to the protein reported.
- The EPA considers the potential allergenicity of the product, issues surrounding gene flow into wild species, possible effects on non-target organisms, likelihood of it persisting in the environment and the potential for insect resistance developing when assessing submissions.
- Before they reach the market, crops from genetically modified seeds are studied extensively to make sure they are safe for people, animals and the environment. Today’s genetically modified products are the most researched and tested agricultural products in history. In fact, genetically modified seeds take an average of $130 million and 13 years to bring to market.
- On average, more than 75 different tests are performed to ensure that GMOs are safe for people, animals and the environment. Unlike new varieties of crops produced by other methods (e.g., mutagenesis, cross-species breeding), GMOs on the market today are tested for food safety, including for allergenicity, digestibility and toxicity.
- In the US, the FDA is responsible for assessing the safety of any genetically modified crop used for food or animal feed.
- The USDA assesses the crop’s potential impacts on the environment and agriculture.
- If the GMO has been modified to provide resistance to pests that would like to eat the crop before humans can, then the EPA assesses the environmental and food safety of the new substance produced by the plant that provides the pest resistance trait.
- Only then do foods from those crops enter our food supply.
Regulation Of GMO Food & Crops In Europe
- …the European Union has had a much stricter regulatory policy in place since 2003.
- There, all GM foods must be strictly evaluated on a case-by-case basis before they’re marketed.
- … even after approval, individual EU countries can request to ban certain GM foods from their borders under a “safeguard” clause.
- As a result, Europe tends to have far fewer genetically modified crops and foods.
- There are differences in the regulation of GMOs between countries, with some of the most marked differences occurring between the USA and Europe.
- Regulation varies in a given country depending on the intended use of the products of the genetic engineering. For example, a crop not intended for food use is generally not reviewed by authorities responsible for food safety.
- The European Union differentiates between approval for cultivation within the EU and approval for import and processing. While only a few GMOs have been approved for cultivation in the EU, a number of GMOs have been approved for import and processing.
- The cultivation of GMOs has triggered a debate about the market for GMOs in Europe. Depending on the coexistence regulations, incentives for cultivation of GM crops differ.
- All applications to develop a GM crop within the EU are assessed using the same regulatory system.
- This involves the European Food Safety Authority (EFSA), the regulatory authorities of independent member states and, finally, approval by the central European authorities in Brussels.
- A recent change has given final responsibility for local implementation back to member states, who can now decide whether to opt out from cultivation of a GM crop that was authorized at the EU level.
- The assessment covers details supplied by the applicant, including the particular GM method used, information about the inserted DNA and characteristics of the plant, and results from animal feeding trials, where appropriate.
- Applications also include an environmental assessment, which examines the possible interactions between the GM crop and factors like soil and other organisms in the ecosystem.
- Since 1992, the EU has approved 2404 experimental GM field trials for research. In comparison, over the same time there have been 18,381 GM trials for research in the USA.
- In crops for commercial use, there is only one GM crop, an insect resistant maize variety, that is grown commercially in the EU and no GM crops have yet been approved for human consumption as fresh fruit or vegetable.
- In comparison there have been 117 commercial releases in the USA since 1992 and in other countries outside Europe. For example, since 1995 there have been 3 permits for commercial releases in China, 41 in Brazil and 93 in Canada. Regulatory systems differ around the world.
- While EU regulations focus on the technique used to modify the crop, other systems, like the Canadian system, focus on the characteristics of the crop produced. In other regions, including many countries in Africa, biosafety regulation is still being developed.
Regulation Of GMO Food & Crops In The UK
- GM crops cannot be grown, either for experiments or commercial farming, without approval by the appropriate regulatory agency, in the UK by DEFRA.
- The movement of GM crops or food between countries is also regulated.
- Details of this process vary from country to country but the same objectives underlie all regulation; that the novel GM crop is safe for human or animal health and the environment.
Regulation Of GMO Food & Crops In Australia
Assessing The Safety Of GMO Foods
- Australian and imported GM foods are assessed for their safety and labelling requirements by Food Standards Australia New Zealand (FSANZ) under the Food Standards Code.
- Assessments are conducted on a case-by-case basis. FSANZ look at risks that arise as a result of the altered genes, risks that come with the intended or unintended use of the product, and if any conditions of use are needed to enable the safe use of the food. It must be shown to be as safe and nutritious as its conventional counterpart.
Assessing The Safety Of GMO Crops
- GM crops are regulated by both the Commonwealth and state governments.
- The Commonwealth Office of the Gene Technology Regulator (OGTR) regulates GM organisms under the Gene Technology Act 2000 and corresponding state and territory laws. The OGTR identifies the risks posed by a GM organism (or dealing with the GMO) to the health and safety of people and the environment. This may be during experiments, growing, transporting, importing. The GMO’s safety is assessed against its conventional counterpart.
The Role Of The States
- South Australia, the ACT and Tasmania all have moratoria on the growing of GM crops. Victoria lifted its ban in 2008, New South Wales has approved GM canola and GM cotton crops, and Western Australia recently lifted its restrictions on GM crops.
GMO Food Labelling In The United States vs Other Countries
United States & GMO Food Labelling
Although labelling of GMO products in the marketplace is required in many countries, it is not required in the United States and no distinction between marketed GMO and non-GMO foods is recognized by the US FDA.
Australia & GMO Food Labelling
[Imported GM ingredients] are unlikely to be labelled as containing GM ingredients.
By law, food that contains GM protein or ‘novel DNA’ must be labelled. And GM foods that have an altered characteristic (e.g. soy beans with increased oleic acid content) compared to the non-GM counterpart must be labelled.
However, the exemptions include:
- GM oils, sugars and starches – Highly refined foods no longer contain the GM protein, according to FSANZ. This includes corn syrup, cottonseed and canola oil.
- GM food additives or processing aids.
- Meat, dairy and eggs from animals fed GM feedstock.
- Food bought from cafes, restaurants, takeaway shops and vending machines.
- GM flavourings in a concentration of no more than 0.1%.
- Unintentionally present GM ingredients of no more than 1%.
GMO Foods & Crops Grown & Imported In Different Countries
You can read about the countries that grow the most GMO foods and crops in this guide.
You can also read about which major countries have growing or importing (of GE ingredients) at bans or prohibitions at https://gmo.geneticliteracyproject.org/FAQ/where-are-gmos-grown-and-banned/