US EPA, Pesticide Registration Services Fees, Revised Microbial and Biochemical Pesticide Data Requirements

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PRIA 2 Workshop November 27, 2007
US Environmental Protection
Agency Biopesticides Pollution Prevention
Michael McDavit, Associate Director
Revised Microbial Biochemical Pesticide Data
Requirements
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Overview

• Background
• Data Requirement Rules for BPPD
• Value of Revised Data Requirements
• Revised Format and General Provisions
• Revised Key Data Requirements
• Definitions
• Pre-submission
• Meetings
• Summary

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Background

• Current data requirement regulations date from
  1984 (40 CFR Part 158)
• Update plans underway for years
• Proposed rule issued March 2006
• Workshops held here and Sacto, CA
• 58 comments from 20 commenters
• Good marks from OMB
• Tips on reading final rules

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Data Requirement Rules for BPPD

• Final rule on conventional pesticides includes
  updated general provisions
• FR Notice - http//www.epa.gov/fedrgstr/EPA-SPECIE
  S/2007/October/Day-26/e20826.pdf (published
  October 26, 2007)
• e-CFR - http//ecfr.gpoaccess.gov/cgi/t/text/text-
  idx?cecfrtpl2Findex.tpl (check site after
  effective date)
• Final rule on microbial and biochemical
  pesticides (see above citations)
• Effective Dec 26, 2007
• Pre-rule on Plant Incorporated Protectants (PIPs)

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Value of Revisions to Microbial Biochemical
Data Reqs

• Reduced Data Set No longer requiring certain
  data (i.e., SCLPs , arthropod pheromones)
• Consultation Process Applicants provided
  enhanced pre-submission consultation process
• Sound Science Better decisions by capturing
  evolution of science over past 20 years
• Clarity Updated definitions greater ease of
  use by improved formatting of data tables and
  requirements
• Transparency Reduced uncertainty allows better
  business planning
• Equity Uniformity and fairness across
  registrations
• Translation ? Better PRIA Packages, Better Service

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Revised Format and General Provisions

• Reorganized subparts (e.g., U V)
• Waiver language rewritten
• CBI policy better articulated
• Use pattern index (old Appendix A) moved to EPA
  website, Pesticide Use Site Index
• (http//www.epa.gov/pesticides/regulating/usesite
  /index.htm)
• Preamble mentions role of pre-submission meetings

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Revised Key Data Requirements

• Identifies scientific data (i.e., information)
  for human health and ecological risk assessments
• Changes to specific provisions
• Product Chemistry and Residue
• Toxicology and Applicator Exposure
• Non-target Organisms Environmental Fate
• Codifies existing case-by-case practice or
  updates existing data requirements

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Microbial Pesticide -New Definition

• Original
• Microbial pesticides include microbial entities
  such as bacteria, fungi, viruses, and protozoans.
• Final
• Microbial pesticide is a microbial agent intended
  for preventing, destroying, repelling, or
  mitigating any pest, or intended for use as a
  plant regulator, defoliant, or dessicant, that
• (1) Is a eucaryotic microorganism including,
  but not limited to, protozoa, algae, and fungi
• (2) Is a procaryotic microorganism, including,
  but not limited to, eubacteria and
  archaebacteria or
• (3) Is a parasitically replicating microscopic
  element, including but not limited to, viruses.

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Biochemical Pesticide -New Definition

• Original
• Biochemical pesticides are generally
  distinguished from conventional pesticides by
  their unique modes of action, low use volume,
  target species specificity or natural occurrence.
  
• Final
• A biochemical pesticide is a pesticide that
• (1) Is a naturally-occurring substance or
  structurally similar and functionally identical
  to a naturally-occurring substance
• (2) Has a history of exposure to humans and the
  environment demonstrating minimal toxicity, or in
  the case of a synthetically derived biochemical
  pesticide, is equivalent to a naturally-occurring
  substance that has such a history and
• (3) Has a non-toxic mode of action to the target
  pest(s).

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Pre-Submission Meetings

• Emphasized in preamble
• BPPD informal waiver procedure
• Pre-submission meeting held
• Signed minutes of meeting submitted with
  application (concurred on by the Agency)
• Lists each data requirement and rationale
• Early, effective planning means fewer (or no)
  renegotiations

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Summary

• Rule revisions reflect evolution of science,
  practice after 20 years experience
• Revisions helps applicants
• Clearer definitions
• Better footnotes
• Updates - adds new, codifies/revises existing,
  and deletes some requirements
• Describes pre-submission informal procedure for
  helping applicants
• Rule effective date December 26, 2007
• Pending applications ? conditional registration
• No Planned DCIs

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