As we are planning to make a food product containing genetically modified organisms (GMOs), we have investigated the current legislation regarding GMOs in food. The European Union has established rules to regulate the safety, authorisation, supervision and labeling of GMOs, which applies to food and animal feed [1]. This legislation aims to protect both human and animal health as well as the environment through high standard safety and risk assessments before a GMO can be placed on the market. In addition, a clear label must be placed on all GMO products, and traceability of all GMOs must be possible.
To apply for authorisation, a single application that covers all uses (food, animal feed and cultivation) must be completed. Within two weeks of the application being sent in, the competent authority in the relevant EU country informs the European Food and Safety Authority (EFSA), who then has six months to process the application [2]. The EFSA panel is made up of scientists from across Europe with expertise in food and feed safety, environmental risk, and molecular characterisation and plant science.
The European Commission is then responsible for the risk management of the GMO. Based on EFSA’s assessment of the application, the Commission drafts a recommendation to either accept or reject the application [2]. The proposal is then sent to the Standing Committee on the Food Chain and Animal Health. If the Committee accepts the proposal, the Commission adopts it. If the application is rejected, the Council of the EU assesses the draft decision and decides if the Commission should adopt it or not. GMOs are only authorised if they are considered safe for human and animal health, as well as the environment [2].
There are very strict rules on the labeling of GMOs. The list of ingredients must clearly say either “genetically modified” or “produced from genetically modified [name of organism]” [2]. If the product contains no packaging, then this label must be placed in close proximity of it, for example in a note on the supermarket shelf where the product is kept. However, if the product contains less than 0.9% GMOs, it does not need to be labeled [2].
The risk management is posed on a case-by-case basis. To get our product on the market, we would need to submit an application where we specify the type of food and describe in detail the method of production and manufacturing. In addition, we would need to state why we want to place our product on the market and that it would not raise any ethical or religious concerns from those consuming it. Since our product is aimed for human consumption, we would need to provide a way for post-marketing monitoring of our yogurt [3].
The EU has a register of all authorized GMOs. It can be searched for products containing certain GMOs. The categories that have been registered are cotton, maize, oilseed rape, soybean, sugar beet and swede-rape [4]. Although, to date, no yogurt products have been found to contain GMOs, The Wall Street Journal reported that a Greek yogurt brand named Chobani has been using milk from cows that have been fed crops that have been genetically modified, such as soybean and corn [5].
Some food products are not GMOs themselves, but include a GMO in it, such as tofu, which can contain modified soy to resist herbicides. Some products on the other hand are GMOs themselves, such as corn. Our product, yogurt, will be mainly made from milk, but it would contain living organisms that have been engineered to produce beta-carotene so it would lie somewhere in the middle of that spectrum. As our yogurt contains material produced by a GMO as well as the GMO itself, we would have to successfully pass the EU criteria for GMO food as explained above to place it on the market. Our product would have to pass the GM Food and Feed Regulation (EC 1829/2003) and EFSA would then make a decision in the next six months after making our application. We understand that GMO approval is a very long process; the arsenic biosensor that started off as Edinburgh’s iGEM project in 2006 are still waiting on their EU approval, but this slow course of action demonstrates responsible development of their product.
GMO legislation is not the same in other parts of the world. For example, the US approach assumes that regulation should “focus on the nature of the products, rather than the process in which they were produced”6. Plant GMOs are regulated under the Plant Protection Act, GMOs in food, drugs and biological products are regulated by the FDA (Food and Drug Administration), and GMO pesticides and microorganisms are regulated by the EPA (Environmental Protection Agency). The rules on GMOs in food supply are more lenient in the US. The FDA treats foods derived from GMOs like those derived from conventionally bred plants, and are “generally recognized as safe” [6]. However, premarket approval is required if the GMO product differs significantly in structure, function or composition from substances that are currently in food [6]. In our case, we would hypothesise that since we are using bacteria already present in yogurt and introduce beta-carotene (which safety is already well-characterised), our product would not require premarket approval. Although, the processes to ensure the level of beta-carotene produced stays below toxic limits will have to be clearly established and robust, and may require assessment. However, it could also be that the FDA takes the view that we intend to use our product to treat illnesses, which could then mean that it becomes a drug, requiring specific approval beyond its GMO status.
India is one of our target countries where the product could be deployed given the ongoing problems with vitamin A deficiency. This may make reception and uptake of our yogurt by policy makers and communities more likely, particularly if they have ownership of it by making the yogurt themselves. Whilst there are regulatory and historical challenges, as well as hostility towards GMOs [7], engagement with these different groups over its responsible development and use could enable a situation where it will be adopted and benefit communities. The use of our SIM device prevents the release of GMOs into the environment, as the bacteria should self-inactivate before leaving the body, would hopefully make our idea more accepted.
References
- ↑ Eur-Lex, 2015. Genetically Modified Food and Feed. Accessed 25/09/2016 at http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=URISERV%3Al21154
- ↑ 2.0 2.1 2.2 2.3 2.4 European Commission, 2016. Genetically Modified Organisms. Accessed 25/09/2016 at http://ec.europa.eu/food/plant/gmo/index_en.htm
- ↑ Library of Congress, 2015. Restrictions on Genetically Modified Organisms: European Union. Accessed 15/10/16 at https://www.loc.gov/law/help/restrictions-on-gmos/eu.php#Foodstuffs
- ↑ European Commission. EU Register of authorized GMOs. Accessed 15/10/16 at http://ec.europa.eu/food/dyna/gm_register/index_en.cfm
- ↑ Gasparro A. and Josephs L. 2013. Whole Foods to Stop Selling Chobani Yogurt. Accessed 15/10/16 at http://www.wsj.com/news/articles/SB10001424052702304367204579266201175528672
- ↑ 6.0 6.1 Library of Congress, 2015. Restrictions on Genetically Modified Organisms: United States. Accessed 15/10/16 at https://www.loc.gov/law/help/restrictions-on-gmos/usa.php
- ↑ Nature News, 2015. India eases stance on GM crop trials. Accessed 15/10/16 at http://www.nature.com/news/india-eases-stance-on-gm-crop-trials-1.17529
