Guidelines/data requirements for registration of technical and formulations of Bacillus Thuringiensis (b.t.) and Bacillus Sphaericus ,(b.s.) under section 9(3B) of the Insectcides Act 1968.
| A. | CHEMISTRY |
| Parameter | Technical | Formulation | |
| 1.1 | Common name of Bacillus Thuringiensis (b.t.) and Bacillus Sphaericus etc. | R | R |
| 1.2 | Systematic name : (Genus, spcies, scrotype and strain) | R | R |
| 1.3 | Physical specification | R | R |
| 1.3.1 | Form and appearence | R | R |
| 1.3.2 | Moisture content | R | R |
| 1.3.3 | PH, partical size, suspensibility, miscibility | R | R |
| 1.4 | Composition | R | R |
| 1.4.1 | Delta Endotoxin content | R | R |
| 1.4.2 | Beta Exotoxin content | R | R |
| 1.4.3 | Viable spore count | R | R |
| 1.4.4 | Adjuvents | R | R |
| 1.4.5 | Human Pathogens (culture method) | R | R |
| 1.4.6 | Other micro organisms (not more than 10000/gm) | R | R |
| 1.5 | Natural Occurrence of the organisms | R | R |
| 1.6 | Test procedure and criteria used for identification - Morphology, Biochemistry, Serology / Immunology | R | R |
| 1.6.1 | Morphology description, particle size, heat resistant spore count. | R | R |
| 1.6.2 | Immunology assays : Elisa / Dot Blot assay test | R | R |
| 1.6.3 | Routine test : | R | R |
| i. Level of beta exotoxins Housefly Bioassay method |
R | R | |
| ii. Potency of product by Bioassay method. | R | R | |
| 1.6.4 | Method of analysis | R | R |
| BIOASSAY METHOD | |||
| a. | LC 50 on terget larvae and potency against a reference using artificial diet or leaf disc method or in the water for mosquito larvae. | R | R |
| b. | Housefly (Bioassay method) for Beta-exotoxin and chemical conteminents | R | R |
| 1.6.5 | Viable spore counts | R | R |
| 1.6.6 | Toxin content by dot blot / Elissa assay | R | R |
| 1.6.7 | Technique for separation and purification of crystals | R | R |
| 1.7 | a. Shelf-life claim | R | R |
| b. Shelf-life data in support of S.L. claim | NR | NR | |
| B. | BIO-EFFICACY | ||
| Technical | |||
| 1. | Laboratory Test : LC 50 values for each insect species under laboratory conditions should be generated atleast at two institutes of ICAR, SAUs, CSIR and ICMR.. | ||
| 2. | Field Trials : Results of field trials conducted with its proposed formulation at institutes of ICAR, ICMR, CSIR, SAUs. | ||
| Formulation : | |||
| 1. | Field Test : Results of field trials conducted by ICAR, SAUs, CSIR/ICMR institutes. Data on phyto-toxicity with formulated material is also required to be submitted alongwith bio-efficacy reports. The data should be certified either by the University Authorities or Head of the Institutes concerned. | ||
| 2. | Data on non target organisms : one season / one
year data on the effect of the product on natural predators / parasites are required to be
submitted.
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| C. | TOXICITY | ||
| Parameter | Technical | Formulation | |
| A. | Single exposure studies | ||
| 1. | Oral toxicity / pathogenicity | R | R |
| 2. | Dermal toxicity / pathogenicity | R | R |
| 3. | Inhalation toxicity / pathogenicity | R | R |
| 4. | Primary skin irritation | R | R |
| 5. | Mucous membrane irritation | R | R |
| 6. | Allergy / sensitization / immuno supression | R | R |
| B. | Eco-Toxicity | ||
| 1. | Toxicity to birds | NR | NR |
| 2. | Toxicity to fish | NR | NR |
| 3. | Toxicity to honeybees | NR | NR |
| 4. | Toxicity to silkworm | NR | NR |
| D. | PACKAGING & LABELLING | ||
| Parameter | Technical | Formulation | |
| A. | Type of packaging System | ||
| 1. | Packaging requirements as per ISI or as per the approval of RC | R | R |
| 2. | New Packaging system approved by FAO / ASPM / Other global standards (relevant) | R | R |
| B. | Manner of Packing | ||
| 1. | Specification of primary packing | R | R |
| 2. | Specification of secondary packing | R | R |
| 3. | Specification of transport packing | R | R |
| 4. | Detailed information for completely filled transport packing containing quantity of primary and secondary packing | R | R |
| C. | Manner of Labelling | ||
| 1. | Labelling on Primary packing | R | R |
| 2. | Labelling on secondary packing | R | R |
| 3. | Labelling on transport packing | R | R |
| D. | Container Content Compatability | ||
| If BIS methodology is not available then as per protocols being approved by RC and validation of analytical method by CIL. | R | R | |
| E. | Labels and Leaflets | ||
| 1. | 7 copies of L/Ls upto 250 ml. | R | R |
| 2. | 7 copies of L/Ls above 500 ml. | R | R |
R - Required
NR - Not Required