REGISTRATION AND SAFETY TESTING OF

BIO-PESTICIDES

DIVISION OF ENTOMOLOGY

BIOPESTICIDES

• Bio pesticides are living organisms which can intervene the life cycle of insect pests in such a way that the crop damage is minimized. The agents employed as biopesticides, include parasites, predetors and disease causing fungi, bacteria and viruses, which are the natural enemies of pests. Further, they complement and supplement other methods of pest control

CONTRIBUTION OF BIOPESTICIDES IN INDIA OUT OF ALL AVAILABLE PESTICIDES

• 0.2% ------------------2000

• 2.5%-------------------2005

• 5%---------------------2013

BIOPESTICIDE SCENERIO IN INDIA• Bt stands first in terms of consumption followed

by neem.• More than 100 companies involved in

manufacture/formulation of bio-pesticides and biocontrol agents.

• Sugarcane borers have been sucessfully managed in Tamilnadu, Karnataka, Odisha, Rajasthan, U.P.,Bihar and Harayana by use of trichogramma.

• Pyrella in sugarcane have also been sucessfully managed in above states by introduction of Epiricamia melanoleuca.

• So far, nearly 500 biopesticides are available in the Indian market duly registered by CIB, but quality control is a major issue in most of the products.

• Extensive research on biopesticides in national laboratories and SAUs have clearly demonstrated the efficacy of biopesticides for management of pests and diseases

TYPES OF BIO-PESTICIDES

1. Biochemical pesticides( like neem, begunia and pheromones)

2. Biocontrol agents (predators,parasites,microbials like bacteria,fungi,viruses)

3. Plant-incorporated protectants (PIPs) have genetic material from other species incorporated into their genetic material

MICROBIAL BIO-PESTICIDES

• Bacteria—Bt product BTK –1kg/ha against lepidopterous insects

• Entomopathogemic viruses-a) Inclusion/ occluded viruses (IV)1. Polyhedral viruses eg.NPV2. Cytoplasmic polyhedrosis virus (CPV)3. Granulosis virus(GV)a) Non inclusion viruses (NIV)

BIOPESTICIDES SHOULD HAVE

PATHOGEN OF SUITABLE STRAIN

SHOULD BE VIRULENT

SHOULD BE PERSISTANT (LONGER SHELF LIFE)

Biopesticides trade names

Bacillus thuringiensis(liquid and WPFormulations)

Dipel, delfin, haltSpicturin, biolepBiobit

Verticillium lacanii Vertilec

Beauveria bassiana Larvocel, boverin

Hirsutella thompsoni Mycar

Metarrhizium anisopliae Biomax

NPV Elcar

BIO-PESTICIDES REGISTRATION

• Government of India has included as many as 45 bio pesticides in schedule to insecticide act,1968

• 18 pesticides have already been registered by registration committee constituted u/s 5 of insecticide act,1968

• However all producers whether government or private organisations are required to have registration of their products under provisions of insecticide act,1968

PRODUCT CHARACTERISTICS FOR BIO-PESTICIDES REGISTRATION

A. BIOLOGICAL CHARACTERISTICS AND CHEMISTRY

B. BIOEFFICACY:

Field studies :data from SAU’s/ICAR Institute certified by Director Research of SAU or Head of the ICAR Institute

Laboratory studies data on LC50 values for each target insect species should be generated at a laboratory under ICAR/ SAU/ CSIR/ICMR.

C. TOXICITY: For mother culture• Single Dose Oral (rat and mouse)

• Single dose pulmonary

• Single dose intravenous

• Cell culture

• Human safety records.

For formulation• Data on mother

culture as in 14 above• Single Dose Oral (Rat &

Mouse)• Single dose pulmonary• Primary skin irritation• Primary eye irritation • Human safety records

LABELS AND LEAFLETS

As per Insecticides Rules, 1971 indicating

the common name, composition, antidote, storage, statements etc

GUIDELINES1. Applicants are required to submit an undertaking that strain is

indigenous, naturally occurring, not exotic in origin, and not genetically modified as per Annexure 1.1.

2. Additional three months data for up to one year shelf-life claim

and additional six months data for more than one year claim at two different agro climatic locations at ambient temperature along with meteorological data should be submitted.

3. Considering the fact that many small entrepreneurs are

engaged in the business of cultivation of NPV/GV, the following mentioned simplification has been suggested.

3.1 If same mother culture is used for making formulation by different entrepreneurs then the information submitted once on mother culture will be sufficient. All entrepreneurs need not to submit data.

3.2 If same mother culture, same method and same

adjutants, stabilizers etc. are used for making formulation, then data once submitted will be sufficient for subsequent registrants.

4. The packaging material should also be ensured free

from contamination from handling, storage and transportation.

Annexure-1.1UNDERTAKING BY MANUFACTURERS OF MICROBIAL PESTICIDES I,-------------------------------------,aged-------years, s/o-------------------------------------------, R/o-----------------------------------------------

and-----------------------------------------of M/s.-------------------------------------------------------------------------------Registered Office at----------------------------------------------------------do hereby undertake as follows:

That the product----------------------------------------------------based on--------------------, Strain-----------------------------,

manufactured by M/s.--------------------------------and /or imported by M/s……………………………………..does not contains any genetically modified organism (GMO) .

That I/We shall abide by the provisions contained in the International Plant Protection Convention with regard to the import of this product.

That I/We shall abide by the provisions in context of International Standards for Phyto-sanitary Measures-Code of Conduct for the import and release of exotic biological control agents of the International Plant Protection Convention (IPPC), FAO, Rome.

That I/We shall provide the samples of our---------------------------------product as and when desired by the competent authorities of Government of India for verification.

That I/We further undertake that in the event of the above product having proved otherwise by any competent authority and resulting in environmental damage, I/We shall inform the Central Insecticides Board and Registration Committee, the relevant authorities for Manufacturing Licensing, Pollution Control and of appropriate District/State/National Level and shall comply with the directions/decisions from them.

That my/our above undertaking is true, and no portion is false and I have concealed nothing relevant to the above matter.

Signature: Date_________ Name--------------------------- Designation--------------------Place:---------------- Seal of the Company--------

Biopesticides Registered under section 9(3) of the Insecticides Act, 1968 for use in the country (as on

15/10/2013). S. No. Name of the biopesticide

1. Azadirachtin (Neem Products)

2. Ampelomyces quisqualis 3. Bacillus sphaericus 4. Bacillus thuringiensis var.

israelIensis 5. Bacillus thuringiensis var.

kurstaki 6. Bacillus thuringiensis var.

galleriae 7. Metarhizium anisopliae

8. Nuclear polyhyderosis virus of Helicoverpa armigera

9. Nuclear polyhyderosis virus of Spodoptera litura

10. Pseudomonas fluorescens 11. Pyrethrins (pyrethrum) 12. Trichoderma harzianum 13. Trichoderma viride 14. Verticillium lecanii

Major target pests of microbial pesticides used in india (Rabindra, 2005).

STEPS FOR SUCESSFUL DEVELOPMENT AND USE OF BIO-PESTICIDES

1) An organisational body need to be established2) Bio-control agents repository established at ICAR and all other SAU’s

need to be further strenthened.3) Bio pesticides should be included in packages of practices,IPM

programmes of SAU’s, ICAR institutes.4) Tax policies should be liberal for youth and tax concession should be

offered to encourage entrepreneurs.5) Rules of registration of bio pesticides should be simple and less rigid than

those of chemical pesticides.6) Loaning policy should be liberal for un-employed agricultural graduates7) Government should provide subsidies/ exemptions or reduction of sales

tax for survival and establishment of bio-pesticides indudtry8) Formulation of biopesticides should be done properly and effective

delivery systems should be created for availibilty of bio-pesticides at door step of farmers.

SAFETY TESTING Safety testing of biopesticides to be done to secure Non-target Vertebrates Mammalsa

Birds(two species)b

Fresh water fishc

Non-target invertebrates Terrestrial Invertebratesd

Soil invertebratese

HAZARDS MAY INCLUDE

INFECTION TO LIVING ORGANISMS

INCORPORATION OF VIRAL NUCLEIC ACID

INTO GENOME OF NON-TARGET ORGANISMS

CANCER

ALLERGY

POISONING

• Routes for hazards may be:1. Oral2. Respiratory3. By wounds4. Dermal

THREE TIER SAFETY TESTINGThe first tier is designed to expose animals to very

severe acute tests with the microbial agents such that the agents can be considered safe if all results are negative.

Any positive result leads to either rejection of agent or to qualification of the effect in the second tier test.

These results in turn lead either to hazard analysis resulting in a decision that the agent is safe without limitation to label restriction, to long term tests on third tier.

• Tier 1st test includes acute oral, inhalation, intra-peritonial, dermal and ocular application plus allergenicity tests and mutagenicity screens.

• Tests in Tier 2nd quantify the effects and include expended mutagenicity tests.

• The 3rd tier comprises teratogenicity and long term tests.

MAJOR ADVANTAGES OF BIO PESTICIDES

Bio-pesticides are preferred over chemical pesticides for the following reasons:

• no harmful residues;• target specific and safe to beneficial organisms like pollinators,

predetors, parasites etc.;• growth of natural enemies of pests is not affected, thus

reducing the pesticide application;• environmental friendly;• cost effective;• important component of IPM as 1st line and 2nd line of

defence, chemicals being the last resort.

CONSTRAINS

• KVK’s and private organisation involved in research related to bio- pesticide development but not reached on the door step of farmers due to:

1. Lack of promotional strategies2. Lack of access3. Lack of awareness4. Lack of willingness of extension workers

• Improper and inappropriate quality of bio-pesticides and their delivery system

• Lack of technical know-how and trained personal for production and use

• Improper toxicology and regulatory matters• Lack of required subsidies and other support

systems• Lack of shelf life of most bio-pesticides is the

most important constrain

REFRENCES

• http://www2.epa.gov/pesticide-registration/biopesticide-registration

• https://www.google.co.in/?gws_rd=ssl#q=need+for+biopesticides+registered

• www.cibrc.nic.in• https://www.google.co.in/?gws_rd=ssl#q=typ

es+of+biopesticides+in+india• The journal on rural development,

KURUKSHETRA magazine