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Organophosphate Pilot Process Discussion

The following paper focuses on the process steps and timelines of Phases 4 and 5 of the OP Pilot Public Participation Process, including the development of the revised risk assessments, intergovernmental review, and public meetings (called Technical Briefings). Two bar graphs are attachment that provide an overview of the process steps and timelines of Phases 1 through 3 (Attachment A), and Phases 4 and 5 (Attachment B). Attachment C summarizes the entire pilot process.

Pilot OP Public Participation Process

Phases 4 and 5

Introduction

The pilot OP Public Participation Process was developed as part of the Tolerance Reassessment Advisory Committee (TRAC) to find a more effective way for stakeholders to participate at critical junctures in EPA's development of OP risk assessment and risk management decisions. EPA and USDA began implementing this pilot process in August 1998 (see TRAC Staff Papers #27 and #34). This paper focuses on Phases 4 and 5 of the pilot process, provides a description of the work products to be developed and activities in each Phase, and progress to date in achieving the objectives.

Overview of the Pilot Process

The following provides a summary of the phases of the pilot process.

Focus on Phases 4 and 5.

EPA and USDA have identified the steps and activities in Phases 4 and 5 that will provide for the development of revised risk assessments and documents. EPA and USDA believe that Phases 4 and 5 should include the following:

Phases 4 and 5 are described below, as well as the progress to date and preliminary thoughts about the pilot process.

Phase 4. Development of Revised Risk Assessment Documents.

Phase 4 begins at the close of the 60-day public comment period (Phase 3), where the public has an opportunity to review and submit comments on the preliminary risk assessments and other materials that have been placed in OPP's Public Docket (and EPA's Internet website).

The pilot OP public participation process allows EPA up to 90 days for Phase 4. EPA will

continue adhere to this schedule and produce the following work products:

STATUS UPDATE: EPA has completed revised risk assessments and Overview documents for 10 OPs using the best information available, and 17 more are now under development.

Intergovernmental Review and Technical Briefings.

EPA and USDA agree that intergovernmental review and opportunities for public involvement are needed of the revised risk assessments. Additional time above Phase 4's 90 days is needed for an effective intergovernmental review and for inter-agency discussions, and for holding public meetings. The following activities are planned:

The time necessary for USDA's review of the revised risk assessments will vary according to the complexity of the chemical and the issues surrounding it. EPA and USDA will work together to designate a 15-day, 30-day, or 45-day review time period for each chemical. EPA will provide briefings for the USDA review team at anytime during their review. By the end of their review period, USDA will transmit their comments to EPA, and both will work together to consider and incorporate the comments into the assessment documents.

EPA and USDA believe that the Technical Briefings will aid public participation because they will give stakeholders opportunities to hear the revised risk assessments explained by EPA and discussed by USDA.

STATUS UPDATE: EPA has transmitted to USDA for their review the revised risk assessment and Overview documents for 10 OPs. USDA has completed the review of 4 OPs, and EPA and USDA are currently engaged in discussions of the Department's comments.

Phase 5. Public Participation.

Phase 5 entails important public participation opportunities.

1. EPA releases the revised risk assessment documents for public viewing by placing them into OPP's Public Docket and Internet website.

STATUS UPDATE: EPA and USDA are now planning Technical Briefings for the 2 OPs that have completed the intergovernmental review process. The release of their revised risk assessment and Overview documents will coincide with their Technical Briefings. The third OP to have completed the intergovernmental review process will not have a Technical Briefing because it is an import tolerance only, nevertheless, its revised risk assessment and Overview will be released along with the first two OPs.

Attachment A

Overview of Phases 1 - 3

of the OP Public Participation Process

PHASE 1

Registrant "Error Correction"

PHASE 2

EPA considers error comments

PHASE 3

Public Comment Period

30 Days

Up to 30 Days

60 Days

* EPA releases the preliminary risk assessments to the OP's registrant(s) for a limited review and comment period (error correction only).

* The registrant is given a 30-day opportunity to identify any computational or other errors in the preliminary risk assessments.

* EPA also sends its assessments to USDA.

* EPA summarizes and considers any error comments it received from the registrant and USDA

* Agency corrects errors in the preliminary risk assessments.

* By the end of this phase, EPA opens a Public Docket for the pesticide.

* EPA publishes a Notice in the Federal Register:

- announcing the availability of the preliminary risk assessments

and related documents in OPP's Public Docket and on EPA's

Internet website, and

-- opens a 60-day public comment period.

* All stakeholders (including registrants, grower groups, and the public) are encouraged to submit data and other information to refine EPA's preliminary assessment, and to begin submitting risk management proposals to address any risk concerns identified in the documents.

* EPA may meet with registrants and other stakeholders to discuss risk related data, use information, and risk assessment/risk management alternatives.

Attachment B

Overview of Phases 4 and 5

of the OP Public Participation Process

PHASE 4

Risk Assessment Refinement

Intergovernmental Review
PHASE 5

Public Participation Period

Up to 90 Days  15 OR 30 OR 45 Days Up to 7 Days 14 Days Later 60 Days
* EPA drafts the revised risk assessments after considering stakeholder comments received on the preliminary risk assessments.

* EPA develops an Overview that summarizes risk findings identified in the revised risk assessments.

* EPA transmits the revised risk assessments to USDA for Intergovernmental Review.

* USDA reviews the revised risk assessments and Overview for either a 15-day, 30-day, or 45-day review period.

* USDA transmits their comments to EPA.

* EPA and USDA discuss USDA's comments and a course of action.1 

* Approximately 1 week after receiving USDA's comments, EPA announces in the Federal Register the date of the Technical Briefing.

* EPA and USDA will hold a Technical Briefing on the OP's revised risk assessments 2 weeks after the meeting is announced in the Federal Register.

* The Technical Briefing provides interested stakeholders with an opportunity to become more informed about the assessment.

EPA will open the public docket at approximately the same time as the Technical Briefing:

* EPA releases the revised risk assessment documents for public viewing.

* EPA will encourage the submission of risk management proposals.

In addition, USDA and EPA may hold meetings with interested stakeholders, jointly or separately, to discuss risk management ideas.

1. Organophosphates with public health uses are following a similar process with the Department of Health and Human Services (DHHS).


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updated April 1, 1998