In 2004, Toxicology Excellence for Risk
Assessment (TERA)
a second review of the captan document was done. This review did
not involve a meeting, but included a paper review of revisions made to
the document as suggested by the 2003 initial peer review. The
initial scientific peer review of a cancer
assessment for captan was held on September 3-4, 2003 at the
University of Cincinnati. A Peer Review Panel reviewed a
document that describes a cancer weight-of-evidence assessment for the
pesticide captan. The document was prepared by VJP
Consulting, Inc. and C. Wilkinson, LLC on behalf of the Captan Task
Force.
Information and Documentation
2004
Peer Review
2003 Peer Review
Background
Captan has been in use as a nonselective
fungicide for over fifty years. EPA currently classifies captan as
a “probable human carcinogen” using their 1986 guidelines for cancer
risk assessment; the weight of evidence characterization has not been
updated using EPA’s more recent draft guidelines. Registrants as
well as other investigators have developed additional data that can be
used to describe a mode of action for captan. In 2001, the Captan
Task Force (CTF) requested that EPA (OPP) re-evaluate captan under its
current draft cancer risk assessment guidelines. The Agency was
not able to allocate resources to this task, reflecting budgetary
constraints and higher priorities. The Agency, however, saw value
in addressing this issue, particularly with the pending tolerance
reassessments for other B2 compounds, and agreed in principle with the
proposal to reevaluate captan by using an independent Third Party
review. This alternative approach is an option EPA is making
available to the Registrants;
that is, while it is noted as a viable approach, the Agency is
not directing
that a Third Party review be undertaken.
The document to be reviewed presents a
cancer hazard assessment and weight of evidence narrative for captan
following EPA’s 2003 Draft Final Guidelines for Cancer Risk
Assessment. The objective of this peer review is to review the
document for the validity of the arguments and conclusions regarding the
characterization of captan. The panel will consider all
relevant data; resolve all questions posed; or, specify where
insufficient data are available for resolution of specific questions.
Principles of sound science will be used throughout this review process.