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The IR-4 Program forRegistration of Biopesticides
MICHAEL BRAVERMANIR-4 Biopesticide Coordinator
IR-4
• IR-4’s mission: to providegrowers with safe, effective andeconomical tools to control pestson minor crops.
•In 1982 a mandate for biopesticideswas added
WHY HAVE A BIOPESTICIDE PROGRAM ?
1. Increased interest in “organic production”. Support minorcrops.
2. Minor crops –no conventional alternatives.
3. Mingling of technology – Integrated Pest Management.
Integrated Residue Management.
4. Merging of technology. Bt was non-conventional, Bt isconventional(adoption by “conventional growers”).
Two Main Functions ofBiopesticide Program
• REGULATORY ASSISTANCE
• GRANTS PROGRAM
BIOPESTICIDE TYPES
MICROBIAL
BIOCHEMICAL
PLANT INCORPORATEDPROTECTANT
Microbials
$160M
Pheromones $60M
$40
Biochemicals
Biological Pesticide MarketBiological Pesticide Market[Still only 1% of global pesticide market][Still only 1% of global pesticide market]
$40M Ben Insects
What areWhat areBiochemicalsBiochemicals??semiochemicals semiochemicals (e.g.(e.g.insect insect pheremonespheremones))
natural plant and insectnatural plant and insectregulatorsregulators
EnzymesEnzymes
hormones (e.g. insecthormones (e.g. insectjuvenile growthjuvenile growthhormones)hormones)
WHAT IS A BIOPESTICIDE?
IR-4 is involved with registration so:
EPA definition = IR4 definition
Biopesticide does not equal organic and organic does notequal biopesticide
Spinosad has organic formulation but is not defined byEPA as a biopesticide.
EPA Biopesticides and Pollution Prevention Division
Naturally occurring product or structural equivalent
Have an indirect mode of action
– Small Company
WHY CONSULTANTS?
Companies havedifferent Strengths
Science
Business
Conventional chemistry
Large company outsidethe U.S., but may lackU.S. expertise
IR-4 Submissions
Thymol/Varroa mite/Bees Sec 18
Kaolin(Suround)/Insects Sec 3
Aspergillus flavus(AF36) /Aflatoxin/Cotton EUP
Verticillium dahliae WCS850(Dutch Trig)/ American elmEUP
Complex RelationshipsIR-4 is a Facilitator Between
Different Groups
IR-4
Registrant
USDAScientist
ContractManufacturer
ToxicologyLabs
ProductChemistry
– Data Packages/Petitions
– EUP’s
– Contract Facilities
– Other consultants
– Cost Estimates $
– Good Laboratory Practices
Regulatory Assistance
• PREPARATION
• REVIEW
• CONSULTING
• SUBMISSION
PETITIONS
IR-4IR-4REGULATORS REGISTRANT
Pre Registration Meeting
Determine Data Needs-Waivers
Protocol Review
Label Language
Timelines-Keeping on Track�Data generation-Which studies takelonger?
�Petition planning-Organize information
�Prompt Responsesfor additionalInformation- Keepreview slot active
Experimental Use Permit
�Preregistration meeting
�Application Process
�Submission
�Facilitate CommunicationBetweenRegistrants and UniversityCooperators
�Other consultants
SUCCESS!
• Grower need is
Fulfilled
Product is registered
Label
Biopesticide Industry Alliance
Ad hoc Member- Working withindustry and the regulatorycommunity on generalregulatory issues
• Efficacy Majority (Advanced StageProjects)
• Labeled products-expansion new crop, pest
___________________________________• Efficacy (Early Stage Projects) Incomplete
toxicology package
GRANTS PROGRAM
Proposals 2002 versus 2003108 proposals $1.2 Million
0
20
40
60
80
100
120
2002 2003
2003 BP Proposals/Awards48 total awards(~ 44% success rate)
0
10
20
30
40
50
60
70
80
Early Advanced
RequestAwarded
2003 BP Grant Dollars$ 427,100
$0
$50,000
$100,000
$150,000
$200,000
$250,000
$300,000
$350,000
Early Advanced
2003 BP Grant by Pesticide
0
5
10
15
20
25
30
Fungicide Insecticide Pheromone Nematicide PGR
2003 BP Grant Type
0
5
10
15
20
25
30
35
40
Food Use Non Food Use
Products funded in multipleproposals
AuxiGro
Sonata
Serenade
Potassium Phosphate
Messenger
Milsana
For more information on IR-4, Contact:
The IR-4 web site at: http://www.cook.rutgers.edu/~ir4
IR-4 Headquarters at: 732/932-9575 (phone) 732/932-8481 (fax)
Michael Braverman Phone Extension 610
