Information provided for informational purposes only

Note: This information is provided for reference purposes only. Although the information provided here was accurate and current when first created, it is now outdated.

Staff Paper #10.2 (cont.) TRAC 6/22-23/98

THREE OPTIONS FOR REFINING RISK ASSESSMENTS


OPTION 1--Registrant Consultation, Federal Register Notice and Public Comment

In this option, the preliminary risk assessment would be shared with the registrant, same as in the current process, and refinements to the risk assessment would be made. At that point the refined risk assessments would be shared with the public for comment, with a summary of the comments provided by the registrant and any changes to the risk assessment made in response to those comments. Risk assessments could be made available to the public through the Agency's public document center, the Agency's Internet site, publishing in the Federal Register, or other possible mechanisms (e.g., meetings). Additional refinements to the risk assessments would then be made based on information and/or data submitted by any of the stakeholders.

OPTION 2--Federal Register Notice and Public Comment

In this option, the Agency would issue the initial risk assessment in the Federal Register for a chemical and provide opportunities for review and comment to all stakeholders at the same time. Refinements to the risk assessment would be made based upon the information/data received from all stakeholders, and then could be shared with the registrants and public for further review. After further refinements are made to the risk assessment, as appropriate, the Agency would then make regulatory decisions. The refined assessment and regulatory decisions would be released to the registrants and the public.

A variation on this option would be to consult with the registrants and other stakeholders separately before release of the preliminary risk assessment.

OPTION 3 (current process)

Under the current process, the Agency develops an initial risk assessment for a chemical (which includes a review of all toxicology and residue data) and then sends the assessment to the registrant(s) of the chemical. The Agency typically meets with the registrant(s) and receives comments on the risk assessment. The Agency reviews all comments and makes any refinements that are appropriate and supported with data. If the risks for any endpoint or subpopulation exceed the safety standard, the registrant is given the opportunity to agree to various Agency-formulated mitigation measures or propose other measures. The final regulatory decisions are published in a Reregistration Eligibility Decision document, which is issued for public comment for 60 days. All supporting documentation is available in a public docket, and the decision is posted to the Internet at the Agency's web site.

WORKGROUP #1 COMMENTS ON

OPTIONS FOR REFINING RISK ASSESSMENTS

OPTION 1 (Registrant Consultation, Federal Register Notice and Public Comment)

Registrant should see the risk assessment before anyone else:

OPTION 2 (Federal Register Notice and Public Comment)

Everyone should see it at the same time (note: significant public education is needed so people can understand this type of information):

OPTION 3 (current process)


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updated June 26 1998