Which question does this study aim to answer?
The ‘Factor GMO’ study will investigate the health effects of a genetically modified (GMO) crop that has been in our food and animal feed supplies for many years. It will answer the question: Is this GMO food and associated pesticide safe for human health?
Farmers, retailers, governments, scientists and consumers have been involved in a heated international debate since GM foods were introduced in 1994. However, there has never been a scientific study that is comprehensive enough to give them a clear answer regarding the safety for human health of any one GM food – until now.
‘Factor GMO’ will be the largest and most detailed long-term experiment ever conducted on of GM food and its associated pesticide. It will add invaluable data of unprecedented power to enable regulators, governments and the general public of every country to answer the question: Is the GM food and associated pesticide really safe at real world levels of consumption/exposure?
The study will also establish a new, higher standard for the rigorous testing of the safety of GM foods and their associated pesticides that will be applicable world-wide.
The full data and results of the study will be made publicly available.
Why do we need an in-depth study on GMO /pesticide safety?
‘Factor GMO’ is one of the main studies that should have been completed before GMOs and glyphosate-based herbicides were released in to the environment. The proposed study examines the long-term safety of the already commercialized GMO under test and of the glyphosate herbicides it is designed to be grown with.
Previous studies have not completed the full range of testing needed to both give the public and regulatory authorities a clear safety picture.
What have been the faults of all of the GMO and pesticide safety studies up until now?
- The vast majority of GMO safety testing has been carried out on rats over a period of only 90 days: this period is not long enough to be able to detect long-term (chronic) health effects. Ninety days in a rat is equivalent to only around 7 years in human terms.
- All safety tests used to justify placing GMOs on the market are carried out by scientists funded by the GM crops/pesticide industry. This has led to a lack of trust in the studies’ design and results.
- Many so-called long-term safety studies that have been carried out on GMOs and glyphosate fail to meet rigorous scientific requirements. They include:
- Studies in which the animals eat the GM diet for only a small proportion of their natural lifetime and which are therefore not long-term at all
- Animal production studies on livestock, which do not examine health effects in detail but focus on effects of the GM diet on issues of interest to farmers, such as weight gain and milk yield
- Studies on animals with a very different digestive system and metabolism from humans, such as cows and fish
- Studies which do not include in-depth toxicity analysis, or multi-generational and carcinogenicity arms – which would give a fuller picture of safety or possible harm.
- Glyphosate herbicides have never been tested in regulatory long-term safety studies in their complete formulations as sold and used by farmers. Only the isolated presumed “active” ingredient, glyphosate, has been tested in long-term studies for regulatory purposes – yet the complete formulations are alleged to be more toxic than the isolated ingredient glyphosate.
‘Factor GMO’ will meet rigorous scientific requirements and will give a more complete picture of the safety for human health of the GMO under test and the associated glyphosate herbicide.
‘Factor GMO’ is the first international long-term combined GMO/pesticide safety study that has involved full multi-generational, toxicology and carcinogenicity arms.
‘Factor GMO’ is the largest and most detailed study ever to be performed on a GMO and its associated pesticide.
What will the study consist of?
Laboratory animals (rats) will be fed certain GM foods and pesticides according to a protocol whose scale, rigour and range of measurements will meet and exceed current international standards for testing the toxicity of GM foods, pesticides, and other chemicals.
The experiment uses more rigorous approaches to investigate the fundamental question of the safety of GM foods and pesticides than are currently required by regulators. It will provide sufficient data to say with confidence whether the real world levels of consumption of the GM food or exposure to its associated pesticide are safe.
The three arms of the experiment will enable vital questions to be answered, such as:
- Is the GM food (or its associated pesticide) toxic to organ systems over the long-term?
- Does the GM food (or its associated pesticide) cause cancer?
- Does the GM food (or its associated pesticide) reduce fertility or cause birth defects?
- Is the mixture of chemicals present in ‘Roundup’ herbicide more or less toxic than its active ingredient glyphosate?
Where will the study take place?
The study will take place at undisclosed locations in Russia and Western Europe. The exact locations of the study must be kept secret for security reasons as we want to avoid any outside interference that could compromise the day-to-day running of the experiments and/or the final results.
Who is funding this study?
The funding process will be totally transparent and a full list of funders will be provided at the start of the experimental phase in 2015. We will not wait for the results to be published before publishing the full list of funders as many scientific studies do.
Up to this stage private individuals from across Russia and the EU have put forward the full funds (to be disclosed next year). We cannot disclose the exact amount of funds collected until now due to contractual agreements with the funders, however we can say that a high percentage of the total needed has been secured, allowing us to start the experimental phase in Spring 2015.
The close to $25 million in funding needed for this project has been/is being sourced from around the world.
Factor GMO has not and will not accept funds from the industry that manufactures GM crops and their associated pesticides.
The funders will have no influence on the design, results, or publication of the study.
Will the study include a multi-generational arm?
This study will be first ever to have a comprehensive multi-generational arm – this will be the first study to thoroughly test for effects on reproductive capability and incidence of birth defects of GMOs and their associated pesticides.
Which GM crop is being studied?
The study will test a herbicide-tolerant GM maize and realistic levels of the glyphosate herbicide it is engineered to be grown with.
We have concentrated our study design on a variety of GM maize. Factor GMO will study other GM Maize varieties and GM soybean varieties if extra funding is made available.
How is this study an improvement on the largest GM food safety study currently being undertaken?
The largest GM food related study that is currently being undertaken is the EUR 3 million EU funded KBBE feeding trial. The KBBE rat feeding trial studies GM maize NK 603.
The following information shows how we have greatly improved on this study:
- This study will have a long-term toxicology arm – the planned EU study will only be for carcinogenicity (no multigenerational component and no focused toxicity component)
- Only EUR 3 million is allocated to the EU study, meaning the breadth of analysis that will be carried out will of necessity be small. The EU study has not been given enough money to conduct a thorough biochemical analysis as part of the carcinogenicity arm, so results will not give a full picture. We will allocate close to EUR 20 million for our study.
- This study will have multiple, interim testing points at regular periods throughout the chronic toxicity phase of the experiment, whereas the proposed EU experiment only has one testing point at the end of the 2 years. By incorporating interim measurements in the study design, this investigation will be the first to identify at what stage any ill-health begins to arise in the animals, and thus trace the progression of any diseases, and clarify the mechanisms (cause of the diseases).
- This study will include detailed molecular profiling analysis to provide mechanistic insight into any illnesses that arise.
- The range of feeding groups in this study is increased to give greater insight than the EU study will give.
- This study will be first to test currently permitted levels of relevant pesticides in both water and feed for toxicity.
- The structure of this study aims to give maximum information with regards to not only monitoring any negative health outcomes but also providing information on the progression and the mechanistic cause of any disease that is observed.
What is the Factor GMO Public Board?
The ‘Factor GMO’ international Public Board is being created to support the study by working with the media and the general public to discuss the need for precautionary science related to GMOs and pesticides, to protect public health worldwide.
The ‘Factor GMO’ Public Board will include influential members from all parts of society, with different points of views regarding GMO safety, however all members will agree on the need for precautionary science.
The Public Board will also support the public, corporate and government funding process for ‘Factor GMO’ and future precautionary science projects. However, the Public Board will have absolutely no involvement in the scientific study.