SAMSIDdHA

Executive Summary

India’s crop protection framework is at a critical transition point. Escalating pesticide resistance, residue-related trade barriers, environmental degradation, and declining efficacy of existing insecticides demand next-generation, low-risk pest control technologies.

RNA-based pesticides, particularly spray-applied double-stranded RNA (dsRNA) products that operate through RNA interference (RNAi), represent a scientifically validated and internationally emerging class of precision bioprotectants. These products silence essential pest genes in a sequence-specific manner, offering high selectivity, rapid biodegradation, and minimal non-target impacts.

Globally, RNA pesticides have crossed a key regulatory milestone with commercial approval in the United States, while regulatory frameworks are evolving in Australia and the European Union. In India, however, no explicit regulatory category or data pathway currently exists for exogenously applied dsRNA pesticides, despite their non-GM nature.

This white paper recommends that India:

1. Create a dedicated regulatory classification for dsRNA-based pesticides under the Insecticides Act.
2. Adopt science-based, proportionate risk-assessment protocols aligned with OECD guidance.
3. Pilot RNA pesticides within Integrated Pest Management (IPM) and Packages of Practices (PoP) for selected crops and storage systems.
4. Enable time-bound conditional registrations to accelerate innovation while safeguarding safety.

1. Background and Rationale

1.1 Limitations of current pesticide paradigms

• Widespread resistance to multiple insecticide modes of action.
• Increasing Maximum Residue Limit (MRL) constraints affecting exports.
• Non-target toxicity impacting pollinators, natural enemies, and soil fauna.
• Regulatory and social pressure to reduce chemical pesticide load.

1.2 Why RNA-based pesticides matter

RNAi-based pesticides differ fundamentally from chemicals:

• Act via gene silencing, not toxicity.
• Are species- and gene-specific.
• Degrade rapidly in soil and water, preventing accumulation.
• Are digitally designable and rapidly adaptable to resistance.

They therefore align strongly with India’s goals of sustainable intensification, residue reduction, and climate-resilient agriculture.

2. What Are RNA-Based (dsRNA) Pesticides?

RNA-based pesticides use double-stranded RNA molecules designed to match a specific gene in a target pest. Upon ingestion:

1. dsRNA is processed into small interfering RNAs (siRNAs).
2. siRNAs guide degradation of the corresponding messenger RNA.
3. The essential gene is silenced, leading to mortality or reproductive failure.

Spray-Induced Gene Silencing (SIGS) avoids genetic modification of crops and is therefore non-GM, distinguishing it from transgenic RNAi approaches.

3. Global Regulatory Status and Precedents

3.1 United States

• The US EPA approved the first dsRNA spray pesticide (targeting Colorado potato beetle) in 2023.
• Classified as a biochemical pesticide, evaluated under FIFRA and FFDCA.
• Approved via a time-limited registration, with post-market monitoring.

3.2 Australia

• Clarified that topically applied dsRNA products are not regulated as GMOs if they do not alter genomes or encode proteins.
• Regulated as agricultural chemical products.

3.3 European Union

• Currently treats dsRNA sprays under existing plant protection product regulations.
• OECD guidance documents for environmental and human health risk assessment are already in place.

Key lesson for India:
RNA pesticides are internationally recognized as distinct from conventional chemicals and require tailor-made regulatory treatment, not blanket inclusion under existing chemical paradigms.

4. Scientific Basis for Risk Assessment

4.1 Target specificity and non-target safety

• RNAi requires sequence complementarity (commonly ≥20 nucleotides).
• Off-target risks can be predicted bioinformatically and confirmed through focused bioassays.
• Pollinators and beneficial insects are affected only if sequence matches and exposure coincide.

4.2 Environmental fate

• dsRNA degrades rapidly in soil and surface water (hours to days).
• No evidence of bioaccumulation.
• Formulations may extend foliar persistence but remain biodegradable.

4.3 Human and animal health

• Dietary RNA is degraded by saliva, gastric acid, and intestinal nucleases.
• No credible mechanism exists for dsRNA integration into human or animal genomes.
• International consensus indicates negligible food safety risk.

4.4 Resistance considerations

• Resistance can emerge (e.g., reduced dsRNA uptake).
• Mitigation strategies include:
  • Rotating RNA targets.
  • Stacking with biologicals or chemicals.
  • Integration into IPM rather than standalone use.

5. Relevance to Indian Agriculture

5.1 Crop systems

RNA pesticides are particularly suited for:

• Horticulture and vegetables (low residue tolerance, export markets)
• High-value plantation crops (chronic pest pressure)
• Field crops with resistance issues (selective mid-season use)

5.2 Storage pests

• Significant potential for grain and pulse storage systems:
  • Species-specific control of beetles and weevils
  • Reduced reliance on fumigants
  • Minimal residue risk in stored food grains

5.3 Alignment with national priorities

• IPM and PoP strengthening
• Reduction in chemical pesticide load
• Promotion of agri-biotechnology and domestic innovation

6. Current Regulatory Gap in India

Under the Insecticides Act, 1968 and existing CIB&RC frameworks:

• Biopesticides are recognized (microbial, botanical, biochemical).
• Exogenously applied dsRNA pesticides are not explicitly classified.
• This creates uncertainty in:
  • Data requirements
  • Risk assessment criteria
  • Registration timelines

As a result, despite strong scientific readiness, commercial deployment in India remains stalled.

7. Policy Recommendations

7.1 Create a new regulatory classification

Introduce a category such as:

“dsRNA-based Bioprotectants / RNAi Pesticides”

Distinct from:

• Synthetic chemical insecticides
• Microbial biopesticides
• GM-based RNAi crops

7.2 Develop tailored data requirements

Adopt a problem-formulation approach, requiring:

• Molecular identity and purity of dsRNA
• Bioinformatics-guided non-target assessment
• Formulation-specific environmental fate studies
• Focused toxicology rather than blanket chemical testing

7.3 Enable conditional and pilot registrations

• Allow time-bound, crop-specific approvals for first-in-class products.
• Mandate post-approval monitoring for non-target organisms and resistance.

7.4 Integrate RNA pesticides into PoP and IPM

• Position RNA products as precision tools, not blanket replacements.
• Issue crop-wise PoP advisories incorporating RNAi options where appropriate.

7.5 Build national capability

• Encourage domestic dsRNA manufacturing and formulation R&D.
• Support ICAR–startup–industry consortia for field validation.

8. Strategic Implications

If India moves early:

• It can shape global regulatory norms, not merely follow them.
• Reduce dependence on imported chemical actives.
• Enable safer pest management for smallholders and export-oriented farmers.
• Strengthen India’s leadership in agri-biotechnology.

If India delays:

• Innovation will migrate elsewhere.
• Farmers will remain dependent on aging, resistance-prone chemistries.
• Regulatory catch-up costs will increase.

9. Conclusion

RNA-based pesticides represent a paradigm shift from chemical toxicity to biological precision. They are not a universal substitute for all insecticides, but they are uniquely suited to address resistance, residue, and sustainability challenges within modern agriculture.

A clear, science-led regulatory pathway under CIB&RC—supported by MoA&FW—can unlock this technology responsibly and position India at the forefront of next-generation crop protection.10. A

10. Annexure

Crop-wise Candidate Use Cases for RNA Pesticides in India

This annex identifies high-impact, low-regret entry points for RNA pesticides in Indian agriculture.

Field Crops

Cotton

• Target pests: Pink bollworm, sucking pests (aphids, whiteflies)
• Role of RNA pesticides:
  • Resistance management tool alongside Bt and chemicals
  • Mid-season targeted intervention
• PoP integration:
  • Threshold-based spray
  • Rotation with conventional MoAs

Rice

• Target pests: Brown planthopper, leaf folder
• Role:
  • Precision suppression to reduce broad-spectrum insecticide load
• Note:
  • Requires formulation optimization due to moderate RNAi sensitivity

Horticulture (High Priority)

Vegetables (Tomato, Brinjal, Okra, Potato)

• Target pests: Beetles, aphids, whiteflies
• Why ideal:
  • High pesticide residues
  • Export sensitivity
• PoP integration:
  • RNA sprays during pre-harvest intervals
  • Replacement of last chemical sprays

Fruits (Grapes, Citrus)

• Target pests: Mealybugs, leaf miners
• Value proposition:
  • Residue reduction + precision targeting

Plantation Crops

Tea, Coffee, Spices

• Target pests: Beetles, borers, sucking insects
• Use pattern:
  • Foliar or trunk-delivered RNA
  • Reduced spray frequency
• Advantage:
  • Long-term sustainability in perennial systems

Storage Pests (Strategic Opportunity)

Grains and Pulses (Wheat, Rice, Pulses)

• Target pests: Weevils, grain beetles
• Application modes:
  • Surface treatment
  • Bait-based RNA delivery
• Benefits:
  • Reduced fumigant dependence
  • Minimal food residue risk
• Policy relevance:
  • Food security + storage loss reduction.

Tarak Dhurjati, A Business leader with expertise in Development of Actionable Intelligence (AI) for Life Sciences, Biotechnology, Agriculture and Allied sectors. AI tools have been used for editing , content generation and illustrations in the above article.