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.  

 This document was written by U.S. EPA, Office of General Counsel on
January 31, 2008.  It was provided via e-mail to the members of the
Carbofuran SAP.

