Registration
Review
Decision
Document:
Work
Group
Recommendations
July
20,
2005
Document
Design
o
Keep
it
Brief
o
Address
different
audiences
o
High­
level
overview
o
Should
be
flexible
enough
to
handle
easy­
off
and
ones
with
risk
concerns
o
Provide
both
links
and
references
o
Free
standing
document
when
printed
Elements
o
Reference
to
previous
regulatory
document
o
Description
of
use
o
Changed
since
last
comprehensive
assessment
o
Summary
of
new
data
o
Describe
risks
of
concern,
mitigation
and
decision
o
Describe
any
new
DCI
and
reasoning
o
No
tolerance
discussion
unless
dietary
risk
of
concern
Other
Considerations
o
Fact
sheet
may
be
useful
o
When
possible,
identify
significant
policy
changes
and
their
impact
o
As
appropriate
describe
any
upcoming
activities
that
may
affect
(
E.
g.;
new
data
requirement)
