Overall Assessment of Acceptability

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Richard Aucoin, Ph.D.
A/Executive Director

Assessment of Acceptability

• Integration of scientific assessment: Health and environmental risks and value of a pesticide must be acceptable to be registered

Process

• Health risk assessment
• Environmental risk assessment
• Value assessment
• Integrated science-based decision-making process

Approach

• Review of data/information completed by science divisions; peer reviews
• Results of evaluation of data, information, risk assessment
• Dietary, exposure, environmental risks must be acceptable
• Value: efficacy, phytotoxicity, lowest effective rate, socio-economic considerations

Considerations

• Complete data base for all areas
• Adequacy of submitted data for all areas
• Encumbered by other issues, e.g. very persistent compound
• Risk management considerations, e.g. conditions of use, use changes, rate changes, compliance
• Other mitigation measures, e.g. buffer zones, protective equipment, application equipment

Mechanism

• Senior management decision

Registration

• Decision making:
  • No: Health or environmental risks or value unacceptable
  • No: Insufficient information
• Decision making
  • Yes: risks and value acceptable
  • Yes: with conditions (e.g. confirmatory chemistry data; long-term monitoring)
  • Yes: consultation

SPIROMESIFEN

• Unusual case re: process and timelines (6 months)
• Normal risk and value assessments
• Received, loaded, screened per normal process
• No preliminary review by science divisions
• Substantial use of USEPA DERs
• No major on-holds; minor deficiencies and clarifications resolved through conference calls
• Bi-weekly internal team meetings (substantial internal coordination for review, labels, documents, certificates)
• Conditional registration was granted
• Evaluation Report created, certificate and labels issued
• Consultation document when confirmatory data (related to residue storage stability) is received in 2008