Regulation of genetically modified food in India and the U.S. – A critical analysis

This blog has been authored by Muhammad Salman Chukkan


Genetically Modified or Engineered Food (GM Food) is defined as “food and food ingredients composed of or containing genetically modified or engineered organisms obtained through modern biotechnology, or food and food ingredients produced from but not containing genetically modified or engineered organisms obtained through modern biotechnology” in the draft Food Safety and Standards (Genetically Modified or Engineered Foods) Regulations, 2021[1]. GM Food has been a buzzword worldwide since 1994, which is well evident from the Google trend analysis.[2]

The introduction of the topic GM Food has brought a fair share of controversies both in India and Worldwide, it seems to be a big socio-political issue in some of the Agrarian economies in the world like India, Brazil etc which is well explained in the article titled ‘Policymaking in the Context of Contestations: GM Technology Debate in India’ by Asheesh Navneet and the News article titled ‘All you need to know about the GM food controversy’ which is published by The Hindu 08/06/2016. [3],[4]

The major concerns revolve around the Health, Ethics and emergence of unexpected risks. The most discussed health concern is emergence of new and super allergens. However the same is generally understood in the safety evaluation by the competent authorities. The second most discussed concern is regarding the build-up of toxins due to the changes happening to the biochemical pathways, the assessment generally becomes a problem due to the limitation in the animal studies. In the ethical viewpoint, Scientists and the general public are concerned about the domino effect or Ice-berg effect of GM Food in the food chain or food web and effect on biodiversity. Emergence of ‘Secondary-pest’ and ‘Superweed’ are also often a discussion, however the Superweed phenomenon is due to over usage of a same herbicide which led to the resistance and Secondary pest is a phenomenon happens even with the traditional pest control system.[5],[6]

The supporters of GM Food on other hand terms the technology as essential for Humankind. This is due to the numerous benefits associated with GM Foods and technology i.e. Reduced usage of pesticides, Increased productivity, Crops better resistance against the drought, Crops with improved nutrition etc. [7],[8],[9]

To learn more about Food laws in India, check out Certificate course in Food and Beverages Law.

Safety Assessment of GM Foods:

The basic assumption is that all the food made in traditional ways are safe to consume.It is worthy to note that we have accepted all the varieties which are being made by using the conventional breeding techniques. All GMO and GM Foods are strictly evaluated for the safety aspects of the product.

The safety assessment of GM Foods is not a singular approach, the assessment shall be conducted differently for different products. For example, a GM Apple made for Pest resistance and GM Apple made for sweetness shall have separate assessment. Evaluating the safety of a GMO is a comprehensive process that involves several steps. Systematic safety assessment methodologies are in place that have been agreed on years of consultations under the aegis of international organizations and agreements viz. Food and Agriculture Organization (FAO), World Health Organization (WHO), Codex Alimentarius Commission, Organisation for Economic Co-operation and Development (OECD) and Cartagena Protocol on Biosafety.

Generally, safety assessment is done with major three types of assessments i.e. Food Safety Assessment, Environmental Safety Assessment and Molecular & Protein characterization. And it is also ensured that no GM Food is released without proper safety evaluation.

To learn more about Food laws in India, check out Certificate course in Food and Beverages Law.

GM Food Regulations in USA

The USA government was always open to GM Technology and GM Food, maybe due to the economic interest of the USA. Also, it is understood that the USA takes a hybrid approach starting with a product-based approach and then if required they take up a process-based approach as well. This may be due to the fact that Americans have been consuming GM Foods since the introduction of Flavr Savr Tomato in 1994. The scientific world is unanimously supporting the GM Food but as per the recent study the American consumers are concerned over GM Food when they find it on label, this is due to widespread misinformation.[10]

The federal government of the USA has made a coordinated approach to regulate the GM Foods in the USA. The federal government released the Coordinated Framework for Regulation of Biotechnology as their policy. The regulation give the responsibility of ensuring the safety on to three different agencies ie. USDA’s Animal and Plant Health Inspection Service (USDA-APHIS) & its Biotechnology Regulatory Services (BRS), the U.S. Environmental Protection Agency (EPA), and the Department of Health and Human Services’ Food and Drug Administration (FDA)(Fig. 2). These three agencies work together to understand the impact of GM Food on the environment. [11],[12],[13], [14],[15]

  • FDA: FDA regulates all the foods including the GMO Foods in the US. They regulate the industry through the Federal Food, Drug, and Cosmetic Act (FD&C Act) and Food Safety Modernization Act which deals with the standards for manufacturing, storage, Transportation, Allergen management, Quality management and labeling.
  • USDA: APHIS, through its Biotechnology Regulatory Services (BRS) program, regulates the introduction of certain organisms developed using genetic engineering that may pose a risk to plant health. The Food Safety and Inspection Service (FSIS) is the public health agency in USDA that is responsible for ensuring that the United States’ commercial supply of meat, poultry, egg products, and fish of the Order Siluriformes is safe, wholesome, and correctly labeled. Under the Federal Meat Inspection Act (FMIA), Poultry Products Inspection Act (PPIA), and Egg Products Inspection Act (EPIA), FSIS inspects all meat, poultry, and processed egg products in interstate commerce. FSIS uses these authorities to regulate products under its jurisdiction, including those derived using genetic engineering.
  • EPA: EPA regulates pesticides, including plants with plant-incorporated protectants (PIP) (pesticides intended to be produced and used in a living plant), to ensure public safety. That agency also regulates pesticide residue on food and animal feed.Under section 408 of the FD&C Act, EPA establishes the amount of pesticide chemical residues that may be present in food. Under the Toxic Substances Control Act and regulations implementing that statute, EPA currently regulates biotechnology products that are new microorganisms not specifically excluded by the statute. Thus working on the plant-incorporated protectants for the safety.

So in a typical outlook when a new GMO is used as PIP, One shall get clearance from EPA. If the same is going as an feed to the Animals they shall get approval of USDA and FDA. This suggests that the regulatory aspects are cumbersome due to involvement of multiple agencies, however the jurisdiction has been clearly defined in the Coordinated Framework for Regulation of Biotechnology which makes the work easy as Government. These three agencies are working together to educate the stakeholders.

But multiple agencies may create confusion and problems among the Food Business Operators and sometimes the Consumers as well.

To learn more about Food laws in India, check out Certificate course in Food and Beverages Law.

GM Food Regulations in India

Since the inception of the discussion of GM Food, India was very much resistant to the concept, may be due to the general mentality of the government with respect to sentiments and concerns to mother nature.

In India, all GMOs including GE plants are regulated by the Ministry of Environment, Forest andClimate Change (MoEFCC) as per rules notified under the Environment (Protection) Act, 1986. Guidelines and protocols are in place for safety assessment of GM foods. GM foods are also subjected to regulations by the Food Safety and Standards Authority of India (FSSAI) under the Food Safety and Standards Act, 2006 and its upcoming draft regulation. As of now FSSAI is having a ‘Zero’ tolerance approach to the GM Foods. This can be understood from some of the Orders or Advisories from FSSAI, refer order dated 21/08/2020 & 27/07/2021.[16],[17],[18]

In India each and every GM Food is required to get a prior approval from GEAC (Genetic Engineering Appraisal Committee, the regulatory authority in MoEFCC. And there are other bodies for Enforcement, Monitoring and Approvals of GMO or GM Food. The final authority to give the go-ahead is the GEAC.

As per the Draft-Food Safety and Standards (Genetically Modified or Engineered Foods) Regulations, 2021, After getting the required approval from the GEAC, the FBO shall get submit application for approval at Food Authority if the product falls under the definition of food as mention in 3(j) of FSS Act 2006. The draft regulation is also providing provision for exemption of approval in 4(11) of Draft-Food Safety and Standards (Genetically Modified or Engineered Foods) Regulations, 2021 i.e. Genetically Modified Organisms having unique identification Code provided by Biosafety Clearing House, Organisation for Economic Co-operation and Development etc, is approved by FSSAI, approval for the same will not be required for any other Food Business Operator. Approval will also not be required if it is used as an ingredient in any product. It also restricts the usage of GM Foods in Infant Foods. Also mentioned the labeling attributes in the regulation.

Critical Analysis:

The Indian regulatory system is taking cautious steps to deal with the risks of GM foods. It is worth noting that the information is easily accessible for someone who is looking at the GM Regulations. However, the US regulations are often cumbersome and messy.

To learn more about Food laws in India, check out Certificate course in Food and Beverages Law.

  3. Policymaking in the Context of Contestations: GM Technology Debate in India, Asheesh Navneet
  5. Genetically modified foods: safety, risks and public concerns—a review, A.S.Bawa and K.R.Anilkumar
  7. A meta-analysis of the impacts of genetically modified crops, Wilhelm Klumper et al.
  8. Development of Drought-Tolerant Transgenic Wheat: Achievements and Limitations, Shabhaz khan et al.
  9. Biofortified Crops Generated by Breeding, Agronomy, and Transgenic Approaches Are Improving Lives of Millions of People around the World, Monika Garg et al.
  11. A new window of opportunity to reject process-based biotechnology regulation, Gary E Merchet et al.
  16. Handbook for Food Safety Officials – Genetically Modified Foods Safety Assessment and Regulations