Research Rundown

Santhosh J. Eapen

In a world where the safety of our food takes precedence over nearly everything else, the recent revisions to the pesticide Maximum Residue Limits (MRLs) for spices and culinary herbs by the Food Safety and Standards Authority of India (FSSAI) have stirred a potent brew of debate. With India as a global leader in spice production, these changes impact not just local markets but also international trade and consumer health. The FSSAI’s decision to increase the MRLs tenfold—from 0.01 mg/kg to 0.1 mg/kg—has sparked a fiery dialogue between government regulators, environmental and health advocates, and the spice industry.

As I have dealt with this topic in a couple of my earlier blogs (Eapen 2023; 2024), this blog post delves into the complex layers of this controversy, examining the scientific, economic, and health implications of the new pesticide standards (FSSAI, 2024). We will explore why the FSSAI believes these revisions are necessary, the concerns raised by environmental and health groups, and what this means for the average consumer who reaches for that jar of turmeric or cumin. Join us as we unravel the spicy debate that is reshaping India’s storied spice trade and raising important questions about food safety standards worldwide. Kindly note that the interpretation of regulations and the significance of various processes are purely based on my personal analysis rather than official explanations from any of these regulatory bodies.

Understanding Pesticide Regulation in India

India, as one of the largest agricultural economies in the world, requires robust systems to manage and regulate the use of pesticides in its diverse farming sectors. The regulation of pesticides is a critical aspect of ensuring food safety, environmental protection, and agricultural productivity. This responsibility falls under the purview of various regulatory bodies, with the Central Insecticides Board & Registration Committee (CIB&RC) playing a pivotal role.

The Central Insecticides Board & Registration Committee (CIB&RC)

The CIB&RC, established under the Insecticides Act of 1968, serves as the central body for the regulation of the manufacture, sale, transport, distribution, and use of insecticides with the aim of protecting public health and preventing risks associated with pesticide use. The main functions of the CIB&RC include (1) Advising the government on technical issues related to the efficacy and safety of pesticides, (2) Registration of pesticides involving a rigorous evaluation of data on the pesticide’s efficacy, toxicity, and safety, (3) Setting quality standards for ensuring that all agricultural and non-agricultural uses of pesticides are safe for humans, animals, and the environment, and (4) Monitoring the use of registered pesticides to ensure compliance with safety and application guidelines.

Process of Pesticide Regulation

The process of pesticide regulation by the CIB&RC involves several key steps:

• Field trials: Depending on the nature of the pesticide, field trials may be conducted to observe the pesticide’s performance in real-world conditions. These trials help determine the optimal dosage and application methods, minimising risks to non-target species and the environment.
• Risk assessment and decision making: Based on the reviews and field trial results, the CIB&RC conducts a comprehensive risk assessment. This assessment considers the potential health risks to humans and animals, as well as the environmental impact. Based on this assessment, the CIB&RC decides whether to approve, restrict, or deny registration.
• Post-marketing surveillance: After a pesticide is approved, the CIB&RC continues to monitor its use and impact, adjusting regulations as new data becomes available or as environmental or health risk patterns emerge.

This stringent and comprehensive regulatory framework ensures that pesticide use in India aligns with both national safety standards and international best practices. It also provides a foundation for continuous improvement and adaptation to new scientific insights and public health needs.

The Role of FSSAI in Setting Safety Standards

FSSAI plays a crucial role in ensuring the safety of food products consumed across the nation. As a regulatory authority, FSSAI is responsible for protecting public health by setting science-based standards for food products and regulating their manufacture, storage, distribution, sale, and import to ensure that safe and wholesome food is available for human consumption. The detailed descriptions of the regulatory processes explained below are interpretations based on publicly available information and my personal understanding.

Maximum Residue Limits (MRLs) are a key aspect of FSSAI’s mandate. MRLs specify the highest amount of pesticide residue that is legally permitted in food products, such as fruits, vegetables, and spices, following the application of a pesticide according to approved agricultural practices. The primary goal of establishing MRLs is to ensure that the pesticide residues in foods remain within safe limits, minimising the risk to consumer health.

Process of Determining MRLs by FSSAI

The determination of MRLs by FSSAI involves a multi-step process that integrates scientific data, risk assessments, and international benchmarks:

1. Collection of data: The process begins with the collection of comprehensive data, including the results of field trials, pesticide usage patterns, and residue data from both domestic and international sources.
2. Risk assessment:

• Toxicological evaluation: Each pesticide undergoes a toxicological evaluation to determine its Acceptable Daily Intake (ADI), which is the amount that can be consumed each day over a lifetime without posing a significant health risk.
• Dietary exposure assessment: FSSAI assesses the dietary exposure of the Indian population to pesticides through food consumption surveys. This helps in understanding how much of a particular food item people consume on average, which is critical for setting realistic and safe MRLs.

3. International harmonisation: FSSAI often considers international standards set by bodies such as the Codex Alimentarius Commission (CAC) in setting MRLs. This harmonisation helps in ensuring that Indian agricultural exports are compliant with global standards, facilitating international trade.
4. Stakeholder consultation: Stakeholder inputs are solicited, including those from industry, academia, and consumer groups, to ensure that all perspectives are considered in the decision-making process.
5. Regulatory approval and notification: Once the MRLs are determined, they are legally mandated through notifications and regulations. These regulations are reviewed and revised periodically to reflect new scientific evidence or changes in agricultural practices.
6. Monitoring and enforcement: Post-regulation, FSSAI along with state and local authorities monitor compliance with the MRL standards. Food products are regularly tested, and actions are taken against non-compliance to ensure public safety.

The FSSAI’s rigorous approach to setting MRLs reflects a commitment to food safety and public health. By basing MRLs on scientific risk assessments and maintaining transparency in its regulatory processes, FSSAI builds public trust in the safety of the food supply. Additionally, it ensures that the regulatory framework for pesticides in food remains robust, scientifically justified, and aligned with international practices, thereby protecting consumers and supporting the agricultural sector.

Scientific Foundations of MRL Adjustments

The process of setting and adjusting MRLs is underpinned by rigorous scientific methodologies and data analysis. FSSAI employs various tools and international resources to ensure that MRLs are based on sound scientific principles and comprehensive risk assessments. Two key tools in this process are the OECD (Organisation for Economic Co-operation and Development) MRL Calculator and the GEMS (Global Environment Monitoring System) Food Consumption Data provided by the World Health Organisation (WHO).

Utilisation of the OECD MRL Calculator

The OECD MRL Calculator is an essential tool used by regulatory bodies, including the FSSAI, to estimate MRLs based on pesticide trial data. Here’s how FSSAI uses this calculator:

1. Input of data: The calculator requires inputs such as the residue levels from supervised field trials, which reflect realistic agricultural practices.
2. Statistical analysis: The calculator applies a statistical model to the input data to estimate the expected maximum residue levels in crops after the application of a pesticide. This helps in determining the MRLs that are both effective in pest control and safe for human consumption.
3. Standardisation: Using the OECD calculator helps standardise the process of MRL determination across different countries, making the MRLs set by FSSAI compatible with international standards.

GEMS Food Consumption Data

The GEMS Food Consumption Data plays a critical role in assessing the dietary exposure to pesticide residues. This dataset provides comprehensive data on food consumption patterns across different populations and is vital for the following:

1. Estimation of exposure: The data helps estimate the daily intake of various foods, which is crucial to understand how much of a pesticide residue an individual might consume.
2. Risk characterisation: By combining the estimated residue levels of pesticides (from the OECD calculator) with the consumption data, FSSAI can assess whether the dietary intake of a pesticide through food could pose health risks to different segments of the population.

Overview of the Risk Assessment Process Employed by FSSAI

The risk assessment process for pesticide residues is a structured approach to determine the potential health risks associated with pesticide residues in food and involves several key steps:

1. Hazard identification: This step involves identifying the pesticide and understanding its chemical properties, toxicity, and the potential health effects it could cause.
2. Dose-response assessment: This phase assesses the relationship between the quantity of pesticide exposure and the severity of its toxic effects. This involves determining the Acceptable Daily Intake (ADI) and Acute Reference Dose (ARfD) for the pesticide.
3. Exposure assessment: FSSAI evaluates the levels of pesticide residues that might be present in food items and the amount of these foods consumed by the population using GEMS data. This helps in estimating the overall exposure of the population to the pesticide.
4. Risk characterisation: This final step combines the information from the dose-response assessment and the exposure assessment to evaluate the overall risk to human health. If the estimated dietary exposure exceeds the ADI or ARfD, it indicates a potential health risk, prompting a need for regulatory actions such as adjusting the MRLs.

Consideration of Pesticide Metabolites

When adjusting Maximum Residue Limits (MRLs), the FSSAI not only relies on direct residue data from pesticides but also incorporates a thorough understanding of residue definitions as per international standards, such as those set by the Codex Alimentarius (CODEX). This approach ensures that the MRLs reflect not just the parent pesticide compounds but also their relevant metabolites and degradation products, which can sometimes pose similar or greater risks than the original substances. By systematically incorporating metabolite data and adhering to international residue definitions, the FSSAI ensures that its MRL settings are robust, scientifically justified, and aligned with global safety standards, thereby safeguarding public health while maintaining the integrity of India’s food supply.

This comprehensive process ensures that the MRLs set by the FSSAI are based on the latest scientific evidence and international best practices, safeguarding public health while supporting India’s agricultural productivity. This is what I understand from my personal insights and may not be the official version of the concerned authorities.

The Case for Revising MRLs in Spices

There are several burning issues pertaining to pesticides in the spice sector (Eapen et al., 2022; IISR, 2022). The revision of MRLs for spices is a strategic decision aimed at aligning India’s regulatory framework with international safety standards while also addressing specific local consumption patterns and agricultural practices. This initiative ensures that Indian spices meet both the global market requirements and safeguard the health of domestic consumers.

Harmonisation with International Standards

Spices are one of India’s signature exports, integral to the culinary traditions around the world. By revising MRLs to align with international standards, particularly those set by bodies like CODEX, India enhances the global competitiveness of its spice exports. This alignment helps in:

1. Facilitating trade: Compliance with international MRL standards reduces barriers to trade, minimising the risk of export rejections due to non-compliance with the importing countries’ pesticide residue regulations.
2. Boosting market access: Harmonised MRLs open up new markets for Indian spices, promoting growth in the export sector.
3. Maintaining reputation: Consistency with global standards helps maintain the reputation of Indian spices as safe and of high quality, which is crucial for sustaining long-term trade relationships.

Responding to Local Health Needs

While international trade is a significant driver for MRL revision, protecting domestic consumer health remains a paramount concern. Spices are used extensively in Indian cuisine, often in much higher quantities than seen in Western diets. Therefore, ensuring that spices are free from harmful pesticide residues is crucial for public health.

1. Dietary exposure considerations: Given the high consumption rates of spices in Indian diets, even small quantities of pesticide residues can accumulate over time. Revised MRLs take into account the cumulative exposure to pesticides, especially those that are persistent or have systemic health effects.
2. Consumer safety: By setting strict MRLs based on rigorous scientific evaluations and risk assessments, FSSAI aims to minimise health risks associated with pesticide residues. This includes considering the toxicological profiles of pesticides and their metabolites, ensuring that consumer exposure remains within safe limits.

Leveraging Advanced Science and Technology

The process of revising MRLs is underpinned by advances in analytical technologies and enhanced regulatory capabilities. These advancements allow for more precise detection of pesticide residues, thereby supporting more stringent and scientifically justified MRLs.

This strategic approach demonstrates India’s commitment to both economic growth and consumer health, fostering trust and confidence in its spice industry at home and abroad.

Debunking Myths: The Truth Behind FSSAI’s Decisions

In the discourse surrounding the revision of MRLs for spices, several myths and misunderstandings have arisen, particularly regarding the decision to fix MRLs at 0.1 mg/kg instead of the previously lower limit of 0.01 mg/kg. Recent media reports suggesting that the FSSAI has allowed high pesticide residues in herbs and spices have been met with firm denial by the authority. The FSSAI has stated these claims as “false and malicious.” Clarifying its position, the FSSAI emphasised that India maintains some of the most stringent MRLs in the world. These MRLs are set after thorough risk assessments conducted by the Ministry of Agriculture and Farmers Welfare, taking into account various factors like dietary consumption patterns and health concerns across all demographics.

Furthermore, FSSAI reiterated that its MRLs for pesticides are established based on comprehensive evaluations, aligning with international standards, such as those set by the Codex Alimentarius Commission. This ensures regular updates reflecting the latest scientific data, upholding rigorous food safety and quality standards across the country. So it’s essential to clarify the scientific and regulatory reasoning behind this decision to ensure transparency and maintain public trust in the safety of food products.

Why 0.1 mg/kg Instead of 0.01 mg/kg?

The decision to set MRLs at 0.1 mg/kg is underpinned by a combination of scientific evidence, technological feasibility, and international regulatory alignment. Here are the key factors that influenced this decision:

1. Analytical limitations: One of the primary reasons for adjusting the MRL from 0.01 mg/kg to 0.1 mg/kg is the limit of quantification (LOQ) achievable by current analytical technologies. At 0.01 mg/kg, detecting and quantifying pesticide residues reliably and consistently across various laboratories and testing conditions can be challenging. Setting an MRL closer to the LOQ ensures more accurate, reproducible, and reliable testing results, which are crucial for both regulatory enforcement and trade.
2. Risk assessment based on scientific data: The FSSAI’s decision is heavily based on comprehensive risk assessments that take into account the Acceptable Daily Intake (ADI) and the actual consumption patterns. The revised MRLs at 0.1 mg/kg are established to be well within the safe limits defined by these risk assessments, ensuring that even with the highest possible residue levels, the pesticide exposure remains within safe limits for consumers.
3. Harmonisation with international standards: Internationally, such as in the United States and Canada, and under Codex Alimentarius guidelines, MRLs are often set at 0.1 mg/kg when sufficient residue data supports such a level. This standardisation facilitates international trade by minimising discrepancies that could lead to trade disputes and barriers.
4. Practical considerations in agriculture: The levels of pesticide residues that can be effectively controlled in agricultural practices often make achieving an MRL of 0.01 mg/kg impractical. The higher MRL of 0.1 mg/kg takes into consideration the realities of agricultural practices, including variations in pesticide applications, environmental factors, and crop types.

Addressing Concerns About Public Health and Safety

Despite the increase in the numeric value of MRLs, I strongly feel that the safety and health of consumers remain a top priority for the FSSAI. It’s important to understand that:

• MRLs are not safety thresholds: MRLs are set based on the maximum expected residues following pesticides used according to good agricultural practices, and they are distinct from safety thresholds. They are designed to be significantly lower than levels that could pose health risks.
• Comprehensive monitoring and compliance: Alongside setting MRLs, the FSSAI enhances its monitoring and compliance mechanisms to ensure that all spices available in the market consistently meet these established limits. This rigorous monitoring helps in maintaining the overall safety of the food supply.

The adjustment of the MRL for spices from 0.01 mg/kg to 0.1 mg/kg by the FSSAI is a well-considered decision that balances the need for practical, enforceable standards with the imperative to protect consumer health. By debunking myths and presenting the facts behind these regulatory decisions, the FSSAI aims to enhance public understanding and trust in its commitment to food safety.

The Role of Media in Scientific Controversies

1. Provide accurate information: Ensure that all reports are based on verified data and sound scientific research, avoiding the dissemination of misinformation.
2. Educate the public: Use the platform to educate readers and viewers about the scientific and regulatory processes involved in setting standards like MRLs. This helps in building an informed citizenry that can engage in meaningful discourse.
3. Offer balanced perspectives: Present multiple viewpoints from credible sources, including scientists, regulatory bodies, and industry experts, to provide a comprehensive view of the issue.
4. Promote rational debate: Encourage rational and constructive debate by hosting expert panels and discussions that delve into the science behind regulatory decisions.

By adhering to these principles, the media can play a constructive role in managing public perception and response during controversies, ensuring that public discourse remains informed, balanced, and beneficial.

Conclusion: Safeguarding the Spice Legacy of India

The FSSAI should remain committed to upholding high standards of food safety, essential for both protecting public health and ensuring the global competitiveness of India’s spice industry. Through rigorous, science-based regulation of MRLs, the FSSAI needs to align with international standards while catering to both local and global market demands.

Future actions for the FSSAI include:

• Strengthen monitoring and compliance: Enhance laboratory capabilities to ensure more precise and timely testing of spice products.
• Increase public awareness: Launch educational campaigns to inform the public about the importance of MRLs and food safety standards.
• Engage with stakeholders: Continuously collaborate with farmers, exporters, and industry groups to gather input and adjust practices as needed.
• Review scientific developments: Regularly update MRLs and safety protocols based on the latest research and international guidelines.
• Promote transparency: Maintain clear, open communication about regulatory processes and changes to foster trust and understanding.

The summary and future outlook provided are based on my personal opinions and not directly sourced from official future plans of the FSSAI or CIBRC. By focusing on these key areas, the FSSAI not only enhances the regulatory framework for spices but also supports the well-being of consumers both domestically and internationally. This proactive and inclusive approach to regulation ensures that India continues to be renowned for its high-quality spices, characterised by safety and purity.

Disclaimer: The views and opinions expressed in this blog are solely my personal reflections and do not necessarily represent the views of any authoritative bodies such as the Food Safety and Standards Authority of India (FSSAI) or the Central Insecticides Board & Registration Committee (CIB&RC). This content is provided for informational purposes only and is not endorsed by any official entities.

Additional Reading

1. Eapen, S.J., Thomas, L., Praveena, R. et al., 2022. Pesticide regulation policy and global food safety for Indian spices. Journal of Consumer Protection and Food Safety 17, 407–410. https://doi.org/10.1007/s00003-022-01387-9
2. Eapen, S.J., 2023. Pesticides and spices: Challenges and implications for domestic and international trade. https://sanjoe.data.blog/2023/02/15/pesticides-and-spices-challenges-and-implications-for-domestic-and-international-trade/
3. Eapen, S.J., 2024. Unraveling the spice conundrum: Pesticide residues and the path to safety. https://sanjoe.data.blog/2024/03/08/unraveling-the-spice-conundrum-pesticide-residues-and-the-path-to-safety/
4. FSSAI, 2024. Maximum Residue Limits (MRLs) of pesticides for spices and culinary herbs. https://www.fssai.gov.in/upload/advisories/2024/04/6616351c775b5Order%20MRL%20Spices%20and%20culinary%20herbs.pdf
5. ICAR – Indian Institute of Spices Research, 2022. The Pesticide dilemma in spice sector: Espousing an enabling policy environment, IISR Policy Brief No. 2. Pp 6. http://spices.res.in/sites/default/files/Policy%20brief2.pdf