EPA

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EPAS PESTICIDE REGISTRATION PROGRAM

• Eugene Thilsted
• Strategic Agriculture Initiative Coordinator
• Environmental Protection Agency Region 6
• Dallas, TX 75202
• January 27, 2004

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OVERVIEW

• Definitions and Framework
• Pesticide Registration
• Crisis Exemptions
• Devices
• Take Home Messages

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FIFRA DEFINITIONS

• The Federal Insecticide, Fungicide, and
  Rodenticide Act (FIFRA) says
• A pesticide is any substance intended to
  prevent, destroy, repel or mitigate any pest, but
  not drugs or liquid medical device sterilants.
• A pest is any form of plant or animal life or
  virus, bacteria, or other microorganism, except
  on or in living man or animals.

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FIFRA DEFINITIONS

• An antimicrobial pesticide is any substance
  intended to kill microorganisms or protect
  inanimate objects from contamination or fouling
  by microorganisms.
• A pesticide device is a mechanical or physical
  contrivance intended to prevent or kill any pest.

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FIFRA FRAMEWORK

• Prior to sale or distribution, a pesticide
  product must be EITHER
• Registered by EPA (Sec. 3), OR
• Granted an exemption (Sec. 18)
• Specific exemption
• Public health exemption
• Crisis exemption

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FIFRA FRAMEWORK

• The only exception to registration or exemption
  under FIFRA is laboratory testing to generate
  data to support a registration or exemption
• Field tests for pesticidal purposes need an
  exemption (see next slide).

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FIFRA FRAMEWORK

• Field tests for pesticidal purposes need an
  exemption.
• Exception conducting experimental field tests
  of new pesticides or new uses of pesticides on
  10 acres or more land or one acre or more of
  water (an EUP Section 5 is required).

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PESTICIDE REGISTRATION (FIFRA Sec. 3)

• Companies must develop their own data and submit
  applications for registration
• Product labeling and required data accompany the
  application
• Registration may be for new product or amending
  existing product

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PESTICIDE REGISTRATIONEFFICACY DATA

• EPA Office of Pesticide Programs (OPP) sets test
  data performance standards

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CRISIS EXEMPTION PROCESS (FIFRA Sec. 18)

• EPA set up expedited process to issue crisis
  exemptions permits the unregistered use of a
  pesticide in a specific geographic area for a
  limited time if emergency pest conditions exist.
• Requests may come from federal, state or local
  agencies, companies, or registrants

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CRISIS EXEMPTION PROCESS (FIFRA Sec. 18)

• Requests must submit/cite efficacy data and
  describe exactly how product will be used
• Usually growers and others encounter a pest
  problem in which there is no registered pesticide
  available.

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CRISIS EXEMPTIONS

• Requests must contain a site-specific remediation
  plan
• EPA reviews requests to assure that a product
  will be effective and safe for the proposed use
• Request needs to address any safety or
  environmental issues

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CRISIS EXEMPTION EFFICACY DATA

• Efficacy data must provide scientific evidence
  that the product will control the specific pest
  in which the Section 18 crisis was submitted

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CRISIS EXEMPTIONS

• State-Specific Registrations
• Section 24C
• States can register a new pesticide product for
  any use (or an additional use) as long as there
  is both a demonstrated special local need and a
  tolerance, exemption from a tolerance, or other
  clearance under FFDCA

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DEVICE

• Means any instrument (other than a firearm) which
  is intended for trapping, destroying, repelling,
  or mitigating any pest or any other form of plant
  or animal life (other than man, bacteria, virus,
  etc.).
• Does not include equipment used for the
  application of pesticides when sold separately.

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TAKE HOME MESSAGES

• Pesticides must have a registration or exemption
  prior to sale or distribution
• Requests for crisis exemptions along with data,
  labeling and plans must be submitted to EPA/OPPTS

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FOR MORE INFORMATION

• VISIT
• www.epa.gov/pesticides
• www.epa.gov/pesticides/factssheets/registration.ht
  m
• Or call the EPA Office of Pesticide Programs
  Registration Ombudsperson
• Linda Arrington 703-305-5446

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