Document ID: EPA-HQ-OPP-2005-0293-0033
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-08-16T04:00Z

Page
1
of
7
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
01­
JUN­
2006
MEMORANDUM
SUBJECT:
Cypermethrin.
Health
Effects
Division
(
HED)
Phase
4
Response
to
Phase
3
Comments
on
the
Cypermethrin
Preliminary
Reregistration
Eligibility
Decision
(
RED)
and
Supporting
Memos.
PC
Code
109702;
DP
Barcodes
D293402
&
D293403.

From:
William
H.
Donovan,
Ph.
D.,
Chemist
John
Doherty,
Ph.
D.,
Toxicologist
Seyed
Tadayon,
Chemist
Reregistration
Branch
3
Health
Effects
Division
[
7509P]

Through:
Danette
Drew,
Branch
Senior
Scientist
Reregistration
Branch
3
Health
Effects
Division
[
7509P]

To:
Dirk
Helder,
Chemical
Review
Manager
Reregistration
Branch
2
Special
Review
and
Reregistration
Division
[
7508P]

FMC
Corporation
has
provided
Phase
3
comments
on
the
cypermethrin
preliminary
RED
and
supporting
memos
in
a
submission
dated
03­
MAR­
2006
(
MRID
46775902).
In
partial
response
to
these
comments,
HED
has
updated
the
following
memos:
1)
Occupational
and
residential
exposure
memo
for
cypermethrin
(
see
D293417,
S.
Tadayon,
05­
APR­
2006).
2)
Human
health
risk
assessment
for
cypermethrin
(
see
D293416,
W.
Donovan
et
al.,
06­
APR­
2006).
Page
2
of
7
Most
of
the
issues
raised
by
FMC
Corporation
have
been
resolved.
Thus,
rather
than
issue
a
point­
by­
point
response
to
each
comment,
below
we
address
the
remaining
issues
where
agreement
has
not
yet
been
reached,
or
where
new
data
have
been
submitted.
For
convenience,
we
have
organized
the
following
discussion
by
document
number
referred
to
in
the
FMC
submission.

Document
1.
Cypermethrin
HED
Chemistry
Chapter
of
the
Reregistration
Eligibility
Decision
(
RED):
Summary
of
Product
and
Residue
Chemistry
Data.
DP
Barcode
D289422.
09­
SEP­
2003.

A.
OPPTS
830.1750
Certified
Limits
FMC
Statement:
FMC
will
address
this
issue
during
a
later
phase
of
the
RED.

HED
Response:
This
deficiency
remains
unresolved.

B.
OPPTS
830.7050
UV/
Visible
absorption
FMC
Statement:
Submission
of
MRID
46775906,
"
Zeta­
Cypermethrin
and
its
Degradates:
UV­
VIS
Absorption
Spectra",
Thomas
Class,
PTRL
Europe
Study:
P661G,
25­
MAR­
2003
HED
Response:
HED
concurs
that
the
UV/
Vis
study
for
zeta­
cypermethrin
may
be
translated
to
cover
the
requirement
for
cypermethrin.
The
study
shows
one
absorption
maximum
at
278
nm.
This
deficiency
is
now
resolved.

C.
OPPTS
830.1800
Enforcement
Analytical
Method
FMC
Statement:
Submission
of
MRID,
"
Cypermethrin
Technical
(
52/
48;
JCPG):
Analysis
and
Certification
of
Product
Ingredients",
Mark
Halfon,
02­
FEB­
2006.

HED
Response:
This
study
is
currently
under
review
by
SRRD/
PRB.

Document
2.
Cypermethrin:
Phase
2
HED
Risk
Assessment
for
the
Reregistration
Eligibility
Decision
(
RED).
D293415,
16­
NOV­
2005.

FMC
Statement:
Requests
update
on
review
of
zeta­
cypermethrin
DNT
study.

HED
Response:
This
review
has
not
been
finalized
yet
but
results
in
the
removal
of
the
10X
database
uncertainty
factor.
A
copy
can
be
forwarded
to
FMC
upon
review
completion.
Page
3
of
7
FMC
Statement:
Drinking
Water
Exposure.
The
drinking
water
paragraph
is
somewhat
misleading.
Cypermethrin
should
not
persist
in
water
as
it
would
quickly
partition
into
the
sediment.
The
levels
of
cypermethrin
modeled
in
water
are
severe
overestimates
based
on
the
physical/
chemical
properties
of
cypermethrin.

HED
Response:
HED
concurs
that
the
water
modeling
approach
produces
conservative
estimates
of
cypermethrin
levels
in
drinking
water.
However,
as
this
standard
approach
results
in
risk
levels
below
our
level
of
concern,
further
refinement
of
these
values
is
not
warranted.

FMC
Statement:
In
response
to
an
identified
data
gap,
FMC
has
submitted
the
following
crop
field
trial
data
for
cotton
gin
byproducts:
MRID
46775904,
"
Magnitude
and
Decline
Pattern
of
the
Residues
of
Cypermethrin
in/
on
Cotton
Treated
with
Six
Applications
of
Ammo
2.5
EC
Insecticide",
John
R.
Arabinick,
Study
No.
191COT04R1,
Report
No.
P­
3806.
134
pages.
23­
FEB­
2006.

HED
Response:
This
study
has
been
summarized
in
the
following
data
evaluation
record
(
DER):
46775904.
der.
It
was
determined
that
this
study
is
scientifically
acceptable
to
satisfy
the
requirements
of
OPPTS
860.1500
for
cotton
gin
byproducts.
The
tolerance
spreadsheet
calculator
recommends
a
tolerance
level
of
11
ppm
for
this
commodity,
based
on
the
submitted
field
trial
results
(
see
Attachment
1).
As
HED
is
not
aware
of
any
compelling
reason
to
depart
from
the
tolerance
spreadsheet
recommendation,
11
ppm
is
the
appropriate
tolerance
level
for
cotton
gin
byproducts.

FMC
Statement:
In
response
to
an
identified
data
gap,
FMC
has
submitted
the
following
waiver
request:
MRID
46775903,
"
Rationale
to
Waive
the
Storage
Stability
Study
of
Cypermethrin
in
Cottonseed
Processed
Commodities",
Audrey
W.
Chen,
Report
No.
P­
3821.
9
pages.
14­
FEB­
2006.
The
FMC
data
waiver
request
points
out
that
cypermethrin
and
zeta­
cypermethrin
storage
stability
studies
have
been
conducted
on
several
diverse
crops
and
processed
commodities.
As
none
of
these
studies
have
demonstrated
stability
problems
with
these
chemicals
in
any
matrix
studied,
it
is
unlikely
that
there
would
be
stability
problems
in
cottonseed
oil.

HED
Response:
HED
concurs
that
the
existing
storage
stability
studies
for
cypermethrin
and
zeta­
cypermethrin
are
adequate
to
support
the
storage
interval
for
processed
cotton
commodities.
Thus,
HED
approves
this
data
waiver
request.

Document
3.
Cypermethrin
and
Zeta­
Cypermethrin:
Occupational
and
Residential
Exposure
Assessment
for
the
Reregistration
Eligibility
Decision
Document.
D289426,
15­
OCT­
2004.

HED
has
addressed
the
FMC's
comments
and
concerns
in
the
following
updated
version
of
the
above
memo:
Page
4
of
7
Cypermethrin
and
Zeta­
Cypermethrin:
Revised
Occupational
and
Residential
Exposure
Assessment
for
the
Reregistration
Eligibility
Decision
Document.
D293417,
05­
APR­
2006.

Document
4.
Cypermethrin:
Toxicology
Disciplinary
Chapter
for
the
Reregistration
Eligibility
Decision
Document.
D289429,
11­
JUL­
2003.

FMC
Statement:
FMC
requested
that
the
following
changes
be
made:
A.
Section
2.0,
page
9:
change
footnote
to
acknowledge
submission
of
zeta­
cypermethrin
DNT
study.
B.
Section
6.2,
page
30:
Add
a
new
paragraph
summarizing
the
results
of
the
DNT
study
and
its
impact
on
the
safety
factors
utilized
in
the
risk
assessment
document.

HED
Response:
An
update
to
the
cypermethrin
toxicology
chapter
including
the
requested
changes
is
being
prepared
and
can
be
forwarded
to
FMC
Corporation
upon
completion.

Document
5.
Cypermethrin.
HED
Response
to
Error­
Only
Registrant
Comments
on
the
Cypermethrin
Preliminary
RED
and
Supporting
Documents,
D298690,
05­
MAR­
2004.

FMC
Statement:
FMC
requested
that
a
sentence
be
added
stating
that
a
developmental
neurotoxicity
(
DNT)
study
with
zeta­
cypermethrin
has
been
submitted
and
is
currently
under
review.

HED
Response:
HED
will
not
make
the
requested
change
since
the
results
of
the
review
of
the
DNT
study
are
discussed
in
other
documents
and
because
the
present
memo
supercedes
Document
5.

Document
6.
Review
of
Cypermethrin
Incident
Reports.
D293143,
26­
AUG­
2003.

FMC
Statement:
FMC
requested
that
the
most
recent
data
be
included
in
the
cypermethrin
incident
report,
and
provided
this
information
as
collected
by
an
emergency
hotline
for
FMC
Corporation.

HED
Response:
HED
requests
a
short
summary
from
FMC
on
the
scope
of
their
contract
incident
report
generation
service,
PROSAR.
We
would
also
need
a
description
of
the
denominators
for
the
data
given
by
FMC
in
percentages,
the
area
of
geographic
coverage,
and
a
copy
of
the
data
collection
protocols
used
by
the
call
center
run
by
PROSAR.
Without
this
information,
we
do
not
know
if
the
data
are
comparable
to
PCC.
Reporting
by
PROSAR
to
a
State
PCC
does
not
insure
data
are
uploaded
to
the
national
AAPCC
reporting
system
that
has
very
strict
data
reporting
requirements.
Low
numbers
can
be
a
true
reflection
of
the
current
situation,
or
a
function
of
under
reporting.
A
comparison
of
protocols
will
assist
in
answering
this
question.
Page
5
of
7
Appendix
1.
Tolerance
Spreadsheet
Calculator
Results
for
Cypermethrin/
Cotton
Gin
Byproducts
Field
Trials.

EPA
Cypermethrin
Cotton
GBYP
13­
14
days
0.60
lb/
A
Residues
LN(
Residues)
Zscores
7.500
2.01
0.54
6.510
1.87
­
0.31
6.820
1.92
0.10
6.510
1.87
­
0.10
8.840
2.18
1.64
5.700
1.74
­
0.79
6.180
1.82
­
0.54
5.530
1.71
­
1.11
4.730
1.55
­
1.64
8.320
2.12
1.11
8.280
2.11
0.79
7.100
1.96
0.31
Page
6
of
7
Regulator:
EPA
Chemical:
Cypermethrin
Crop:
Cotton
GBYP
PHI:
13­
14
days
App.
Rate:
0.60
lb/
A
Submitter:

n:
12
min:
4.73
max:
8.84
median;
6.67
average:
6.84
95th
Percentile
99th
Percentile
99.9th
Percentile
9.0
10
11
EU
Method
I
Normal
(
11)
(
12)
(­­)

10
11
12
EU
Method
I
Log
Normal
(
12)
(
14)
(­­)
17
EU
Method
II
Distributio
n­
Free
11
California
Method
µ
+
3 
UPLMedian95
th
50
Approximate
Shapiro­
Francia
Normality
Test
Statistic
0.9786
p­
value
>
0.05
:
Do
not
reject
lognormality
assumption
Page
7
of
7
Lognormal
Probability
Plot
99.9
99
98
95
90
80
70
50
30
20
10
5
2
1
0.1
9.0000
4.5000
y
=
0.1933x
+
1.9066
R
2
=
0.9786
Percentiles
Concentrations
EPA
Cypermethrin
Cotton
GBYP
13­
14
days
0.60
lb/
A