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Scope of EPA Charge to SAP on Carbofuran NOIC
Scope of EPA Charge to SAP on Carbofuran NOIC (1/31/08)
- The SAP is charged with providing scientific and/or technical advice to EPA on the potential impact on human health and the environment of the action proposed in the Agency’s notice of intent to cancel (NOIC). FIFRA section 25(d).
- This means that they may properly provide advice addressing any scientific and/or technical issue relating to the scientific bases for EPA’s analyses and conclusions regarding carbofuran’s risks to human health and the environment outlined in the NOIC.
- EPA has identified the scientific issues that it believes are most critical to its risk assessment, and/or on which it has not previously solicited advice from the SAP. These are reflected in the charge questions. The SAP must, at a minimum, provide answers to the charge questions.
- To the extent that the SAP wishes to address other issues relating to the scientific and technical aspects of the human health and ecological risk analyses and conclusions laid out in the NOIC, they are not precluded from this. These may be issues raised by the public or by individual SAP members.
- However, this does not include (and therefore the SAP should not provide advice on) the following issues:
1) The economic benefits associated with use of carbofuran. FIFRA section 25(d) limits the SAP’s role in reviewing proposed cancellation actions to the impact of the action on human health and environment.
2) EPA’s regulatory policy conclusions. The SAP’s role is to comment upon the soundness of EPA’s scientific basis for its risk conclusions, not to provide advice as to whether EPA should cancel carbofuran’s registration.
3) Recommendations for the development of new data or methodologies. FIFRA established a deadline for EPA to make a reregistration decision for carbofuran; EPA’s decision must therefore be based on the available data. Consequently, unlike previous SAPs, the Agency is not asking for the SAP to provide advice and recommendations relating to the development of new scientific methodologies or whether the scientific basis for a regulatory decision could benefit from the development of additional data. To the extent they wish to provide such advice, it must be in addition to advice that addresses the specific charge questions the Agency has presented.
4) The Agency will not be asking the SAP to address the carbofuran human studies (oral or dermal) as the scientific and ethical issues associated with these studies have already been reviewed by the Agency's Human Studies Review Board (HSRB), the FACA group charged with evaluating these issues. Consequently, the SAP should not reconsider these issues.