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Public Participation Process for Tolerance Reassessment and Reregistration Summaries

Summary of Full, 6 Phase Public Participation Process for Tolerance Reassessment and Reregistration

  • Pre-Phase 1 - Stakeholder and Government Agency Engagement; Develop Updated Use/Usage Information. A significant focus is to engage stakeholders as early as possible so risk assessments reflect actual use and usage, available data, current labeling, and other information stakeholders can provide. About a year before Phase 1, EPA begins sharing use/usage information about a pesticide (noting what updated information would be valuable) with USDA, other Federal, State, and Tribal government agencies, and key stakeholders. To initiate Pre-Phase 1, EPA, USDA, and other Federal agencies may organize a meeting or meetings with key stakeholders to discuss use and usage. Within 60 days, EPA provides a summary of current use/usage for sites to be included in the risk assessments. Updated summary information contributed by stakeholders is compiled and also made publically available (via the Internet) to encourage further discussion.
     
  • Phase 1 (30 days) - Registrant "Error Only" Review. EPA sends human health and ecological risk assessments to the technical registrant(s) of the pesticide for a 30-day error correction review, asking them to identify and correct any computational or other errors. Soon after, EPA sends risk assessments to USDA/other Federal agencies as appropriate for their review and comment.
     
  • Phase 2 (up to 30 days) - EPA Considers Registrants' Comments. EPA considers errors identified by the registrant(s) and corrects the errors as appropriate. EPA considers USDA's and other Federal agencies' comments, and transmits an overview summarizing the risk assessments to the agencies. EPA completes the risk assessments for public release.
     
  • Phase 3 (60 to 90 days) - Public Comment on Risk Assessments and Risk Characterization. EPA publishes a Federal Register (FR) notice announcing availability of the risk assessments and related documents from the public docket and EPA's website, and opening a 60- to 90-day comment period. Federal, State and Tribal agencies engage stakeholders in dialogue on risk assessment/characterization.
     
  • Phase 4 (up to 90 days) - EPA Revises Risk Assessments, Develops Preliminary Risk Reduction Options. EPA considers public comments received during Phase 3, revises the risk assessments, and develops preliminary risk reduction options. EPA may prepare and release an initial benefits characterization, and may consult with CDC on public health benefits, as needed. EPA briefs other Federal agencies, and States and Tribes (often through a regulatory partners conference call); and participates in USDA-led stakeholder conference calls. EPA and USDA may host a Technical Briefing and/or stakeholder meetings to discuss the revised risk assessments and initial risk reduction options. The Federal agencies may begin a dialogue with stakeholders on benefits and transition.
     
  • Phase 5 (60 days) - Public Comment on Risk Reduction. EPA publishes an FR notice announcing availability of the revised risk assessments and response to comments. EPA also releases and invites public comment during the next 60 days on preliminary risk reduction options, a qualitative impact discussion (when EPA has identified risks of concern), and a discussion of any potential transition issues. The public is encouraged to suggest risk management proposals. Federal agencies begin a dialogue with stakeholders on risk reduction and risk management.
     
  • Phase 6 (up to 60 days) - EPA Develops Final Risk Management. EPA considers comments and risk management ideas submitted during Phase 5. With input from other agencies and stakeholders, EPA develops a risk management decision. EPA releases the decision, including a benefits discussion/ assessments as needed. USDA may prepare a transition strategy, if needed.
     
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    Summary of Modified, 4 Phase Public Participation Process for Tolerance Reassessment and Reregistration

  • Pre-Phase 1 - Stakeholder and Government Agency Engagement; Develop Updated Use/Usage Information. A significant focus is to engage stakeholders as early as possible so risk assessments reflect actual use and usage, available data, current labeling, and other information stakeholders can provide. About a year before Phase 1, EPA begins sharing use/usage information about a pesticide (noting what updated information would be valuable) with USDA, other Federal, State, and Tribal government agencies, and key stakeholders. To initiate Pre-Phase 1, EPA, USDA, and other Federal agencies may organize a meeting or meetings with key stakeholders to discuss use and usage. Within 60 days, EPA provides a summary of current use/usage for sites to be included in the risk assessments. Updated summary information contributed by stakeholders is compiled and also made publically available (via the Internet) to encourage further discussion.
     
  • Phase 1 (30 days) - Registrant "Error Only" Review. EPA sends human health and ecological risk assessments to the technical registrant(s) of the pesticide for a 30-day error correction review, asking them to identify and correct any computational or other errors. Soon after, EPA sends risk assessments to USDA/other Federal agencies as appropriate for their review and comment.
     
  • Phase 2 (30 to 60 days) - EPA Considers Registrants' Comments on Risk Assessments; Develops Preliminary Risk Reduction Options. EPA considers errors identified by the registrant(s) and corrects the errors as appropriate. EPA considers USDA's and other Federal agencies' comments, and transmits an overview summarizing the risk assessments to the agencies. EPA completes the risk assessments for public release. Because only nominal risk mitigation is needed for the pesticide, EPA also develops preliminary risk reduction options, making an effort to consult with stakeholders and other agencies. This consultation will continue through Phase 4.
     
  • Phase 3 (60 to 90 days) - Public Comment on Risk Assessments and Preliminary Risk Reduction Options. EPA publishes a Federal Register notice announcing availability of the risk assessments and preliminary risk reduction options for public comment. EPA continues significant efforts to consult with other government agencies and stakeholders on the pesticide's uses and possible risk management options.
     
  • Phase 4 (up to 90 days) - EPA Develops Final Risk Assessments and Risk Management. EPA considers public comments and risk management ideas and proposals received during Phase 3, continues the ongoing dialogue with other agencies and stakeholders as needed, and develops a risk management decision, which the Agency may issue for public comment, as needed.
     
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    Summary of Low Risk Public Participation Process for Tolerance Reassessment and Reregistration

  • EPA's initial screening of a pesticide indicates that it has low use/usage, affects few if any stakeholders or members of the public, and/or poses low risk and requires little or no risk mitigation. Neither the full 6-phase nor the modified 4-phase process is needed. Therefore, the Agency prepares a decision document for the pesticide, concluding the review process. EPA issues this decision document, the risk assessments, and related documents for public comment.
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