Food safety authority oversight of edited food supply

Introduction

Gene-edited foods are agricultural and food products developed through modern biotechnology techniques that make targeted changes to an organism's genetic material. Technologies such as CRISPR-Cas are used to develop crops with improved nutritional characteristics, disease resistance, higher productivity and tolerance to environmental stress.

Although gene editing may not always involve introducing foreign genetic material, it raises important questions concerning food safety, nutritional composition, allergenicity, environmental effects and consumer information. Food safety authorities therefore play an important role in assessing, regulating and monitoring edited food products before and after they enter the food supply.

In India, the Food Safety and Standards Authority of India (FSSAI), together with biotechnology and environmental regulatory authorities, forms part of the regulatory framework governing these products.

Meaning and importance of regulatory oversight

Food safety authority oversight refers to the legal and administrative supervision exercised by government agencies to ensure that food products meet prescribed safety and quality requirements.

For gene-edited foods, oversight may involve examining the genetic changes, nutritional characteristics, potential toxicity, allergenicity and intended use of the product.

The main objectives include:

Protecting consumers from unsafe food products.

Ensuring scientific assessment of gene-edited crops.

Preventing misleading food labels and advertisements.

Monitoring compliance with food safety standards.

Maintaining transparency in food supply chains.

Supporting responsible biotechnology innovation.

Legal framework in India

1. Food Safety and Standards Act, 2006

The Food Safety and Standards Act, 2006, establishes FSSAI as the principal food safety regulatory authority in India.

Section 16 provides for the functions of FSSAI, including establishing food standards and regulating the manufacture, storage, distribution, sale and import of food.

Section 18 establishes general principles for food safety administration, including protection of human health and the application of risk-based approaches.

Section 26 places responsibility on food business operators to ensure compliance with the Act and applicable regulations.

These provisions provide the foundation for food safety supervision of gene-edited products.

2. Environment (Protection) Act, 1986

The Environment (Protection) Act, 1986, provides the statutory basis for regulating genetically engineered organisms and potentially hazardous biological materials.

Section 6 empowers the Central Government to make rules concerning environmental protection and hazardous substances.

The Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells Rules, 1989, were framed under this legislation.

These Rules establish regulatory responsibilities involving the Review Committee on Genetic Manipulation (RCGM) and Genetic Engineering Appraisal Committee (GEAC), among other authorities.

3. DBT Guidelines, 2022

The Department of Biotechnology issued guidelines for the safety assessment of genome-edited plants in 2022.

The guidelines recognise specified categories of genome-edited plants, particularly SDN-1 and SDN-2 plants, that do not contain foreign genetic material in the final product.

Certain qualifying plants are exempted from specified provisions of the 1989 Rules, subject to prescribed conditions and verification requirements.

This exemption is conditional and does not mean that every gene-edited food automatically escapes regulatory oversight.

4. Food Safety and Standards Regulations

The Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011, and the Food Safety and Standards (Labelling and Display) Regulations, 2020, establish relevant requirements concerning food contaminants, residues and consumer information.

These requirements apply according to the nature of the product and its regulatory classification.

Responsibilities of food safety authorities

FSSAI and other competent authorities perform different but complementary regulatory functions.

1. Scientific risk assessment

Authorities must consider whether edited food products present potential risks relating to toxicity, allergenicity, nutritional changes or unintended compositional effects.

2. Regulatory approval and classification

The applicable regulatory pathway must be determined according to the organism, genetic modification and relevant statutory exemptions. Environmental release and food safety oversight should not be treated as identical regulatory processes.

3. Food inspection and testing

Food safety authorities may inspect food businesses, collect samples and examine whether products comply with applicable food standards.

4. Labelling and consumer protection

Authorities must ensure that food businesses comply with applicable labelling requirements and do not make misleading claims about product composition, nutritional benefits or production methods.

5. Post-market monitoring

Monitoring helps identify unexpected food safety concerns after products enter commercial distribution. Where necessary, authorities may take corrective action, including product withdrawal or recall under applicable law.

Important judicial decisions

1. Aruna Rodrigues v. Union of India (2024)

The Supreme Court considered issues concerning the approval and environmental regulation of genetically modified mustard. The opinions differed on important questions, and the matter was referred to a larger bench.

The proceedings highlight the importance of transparent scientific assessment, regulatory accountability and careful examination of biotechnology-related risks.

2. Vellore Citizens' Welfare Forum v. Union of India (1996)

The Supreme Court recognised the precautionary principle as part of Indian environmental law. This principle supports preventive regulatory action where scientific uncertainty exists regarding possible environmental or health consequences.

3. A.P. Pollution Control Board v. Prof. M.V. Nayudu (1999)

The Supreme Court emphasised the importance of scientific expertise in environmental decision-making. Its reasoning is relevant to the technical assessment of gene-edited agricultural products and their possible environmental effects.

4. S. Samuel, M.D., Harrisons Malayalam v. Union of India (2004)

The Supreme Court examined statutory regulation concerning agricultural products. The judgment illustrates the importance of compliance with applicable regulatory requirements governing products entering commercial markets.

These decisions do not directly establish a complete legal framework for FSSAI oversight of gene-edited foods. They provide relevant principles concerning scientific assessment, precaution and regulatory compliance.

Challenges and recommendations

Food safety authorities face several challenges when regulating edited food products. Different gene-editing techniques may produce different biological outcomes, making uniform regulatory assessment difficult.

Other concerns include limited public awareness, difficulties in product identification, international differences in regulatory classification and uncertainty concerning long-term effects.

To strengthen oversight, authorities should:

Establish clear and scientifically justified assessment criteria.

Improve coordination between FSSAI, DBT and environmental regulators.

Develop appropriate testing and monitoring facilities.

Maintain transparent approval and exemption records.

Strengthen consumer information and traceability.

Review scientific evidence periodically.

Conclusion

Food safety authority oversight is essential for ensuring that gene-edited foods entering the market are safe, properly regulated and accurately represented to consumers. In India, the Food Safety and Standards Act, 2006, the 1989 Biosafety Rules and the DBT Guidelines, 2022, provide important elements of the regulatory framework. FSSAI plays a central role in food safety, while biotechnology and environmental authorities address other aspects of regulatory assessment. Effective coordination, scientific evaluation and continuous monitoring are necessary to balance technological innovation with consumer protection and public health.