Document ID: EPA-HQ-OPP-2005-0177-0014
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2005-12-28T05:00Z

United
States
Prevention,
Pesticides
EPA
738­
F­
05­
XX
Environmental
Protection
and
Toxic
Substances
August
2005
Agency
(
7508C)

Metiram
Facts
Pesticide
Reregistration
All
pesticides
sold
or
distributed
in
the
United
States
must
be
registered
by
EPA,
based
on
scientific
studies
showing
that
they
can
be
used
without
posing
unreasonable
risks
to
people
or
the
environment.
Because
of
advances
in
scientific
knowledge,
the
law
requires
that
pesticides
which
were
first
registered
before
November
1,
1984,
be
reregistered
to
ensure
that
they
meet
today's
more
stringent
standards.

In
evaluating
pesticides
for
reregistration,
EPA
obtains
and
reviews
a
complete
set
of
studies
from
pesticide
producers,
describing
the
human
health
and
environmental
effects
of
each
pesticide.
To
implement
provisions
of
the
Food
Quality
Protection
Act
of
1996,
EPA
considers
the
special
sensitivity
of
infants
and
children
to
pesticides,
as
well
as
aggregate
exposure
of
the
public
to
pesticide
residues
from
all
sources,
and
the
cumulative
effects
of
pesticides
and
other
compounds
with
common
mechanisms
of
toxicity.
The
Agency
develops
any
mitigation
measures
or
regulatory
controls
needed
to
effectively
reduce
each
pesticide's
risks.
EPA
then
reregisters
pesticides
that
meet
the
safety
standard
of
the
FQPA
and
can
be
used
without
posing
unreasonable
risks
to
human
health
or
the
environment.

When
a
pesticide
is
eligible
for
reregistration,
EPA
explains
the
basis
for
its
decision
in
a
Reregistration
Eligibility
Decision
(
RED)
document.
This
fact
sheet
summarizes
the
information
in
the
RED
document
for
the
pesticide
metiram,
case
number
0644.

Regulatory
History
Metiram
was
first
registered
in
the
United
States
in
1948
for
use
on
food
and
ornamental
crops
to
prevent
crop
damage
in
the
field
and
to
protect
harvested
crops
from
deterioration
in
storage
or
transport.
Metiram
is
a
member
of
the
ethylene
bisdithiocarbamate
(
EBDC)
group
of
fungicides,
which
includes
the
related
active
ingredients
mancozeb
and
maneb.
The
EBDCs
share
the
common
degradate
ethylenethiourea
(
ETU).
EPA
has
considered
aggregate
risk
from
ETU
from
all
sources
as
a
part
of
the
RED.

The
EBDCs
have
been
the
subject
of
two
Special
Reviews.
In
1977,
the
Agency
initiated
a
Special
Review
for
products
containing
EBDCs
based
on
evidence
suggesting
that
the
EBDCs
and
ETU,
a
contaminant,
metabolite
and
degradation
product
of
these
pesticides,
posed
potential
risks
to
human
health
and
the
environment.
In
1982,
the
Agency
concluded
this
Special
Review
by
issuing
a
Final
Determination
(
PD
4)
which
required
risk
reduction
measures
to
prevent
unreasonable
adverse
effects
pending
development
and
submission
of
additional
data
needed
for
improved
risk
assessment.
2
The
Metiram
Registration
Standard
Document
was
issued
on
September
8,
1986,
an
Addendum
to
the
Registration
Standard
on
January
13,
1987,
and
an
Update
to
the
Metiram
Registration
Standard
on
August
11,
1992.
In
1987,
EPA
issued
a
second
Notice
of
Initiation
of
Special
Review
of
the
EBDC
pesticides
because
of
health
concerns
caused
by
ETU,
including
potential
carcinogenic,
developmental
and
thyroid
effects.
Subsequent
Data
Call­
Ins
(
DCIs)
were
issued
in
1988
and
1995
which
included
standard
and
worker
exposure
data
requests,
respectively.
The
Special
Review's
Preliminary
Determination
(
PD
2/
3)
was
published
on
December
20,
1989
(
54
FR
52158)
and
the
Final
Determination
(
PD
4)
on
March
2,
1992
(
57
FR
7484).
The
Agency
concluded
that
the
dietary
risks
of
EBDCs
exceeded
the
benefits
for
the
following
food/
feed
uses
for
which
one
or
more
of
the
EBDC
pesticides
were
registered:
apricots,
carrots,
celery,
collards,
mustard
greens,
nectarines,
peaches,
rhubarb,
spinach,
succulent
beans,
and
turnips.
Accordingly,
EPA
canceled
all
metiram
and
other
EBDC
products
registered
for
use
on
the
above­
listed
food/
feed
crops.
Currently,
the
only
food/
feed
uses
of
metiram
eligible
for
continued
registration
are
apples
and
potatoes,
provided
the
label
revisions
are
submitted.

Uses
°
Metiram
is
used
on
apples,
potatoes,
and
ornamental
plants
(
leatherleaf
ferns)
in
nurseries
and
greenhouses.
Metiram
was
previously
registered
for
use
on
tobacco
seedlings
and
roses,
but
these
uses
have
since
been
voluntarily
cancelled.
There
are
no
residential
labels,
and
no
agricultural
uses
that
could
result
in
exposure
to
metiram
in
residential
settings.

°
Approximately
900,000
pounds
of
metiram
are
used
for
about
125,000
acres
treated
on
an
annual
basis.

°
Metiram
is
not
a
Restricted
Use
Pesticide
(
RUP)
.

Health
Effects
°
Similar
to
other
EBDCs
and
ETU,
the
thyroid
is
the
target
organ
for
metiram.
Thyroid
effects
observed
in
subchronic
studies
in
rats
include
increased
thyroid
weights,
increased
thyroid
stimulating
hormone
(
TSH)
and
decreased
T
4
(
serum
thyroxin)
values.

Risks
°
Acute,
chronic,
and
cancer
dietary
(
food
only)
risk
from
metiram,
metiram­
derived
ETU,
and
ETU
from
all
sources
are
low
and
below
the
Agency's
level
of
concern.

°
The
drinking
water
exposure
assessment
for
metiram
addresses
concentrations
of
ETU
only,
since
metiram
is
not
expected
to
remain
in
drinking
water
long
enough
to
reach
a
location
that
would
supply
water
for
human
consumption,
whether
from
surface
or
groundwater
sources.
Estimated
concentrations
of
ETU,
for
both
surface
and
ground
water
sources
of
drinking
water,
are
low
and
not
of
concern.
3
°
There
are
no
registered
residential
uses
of
metiram,
thus
no
residential
risks
were
assessed.

°
Acute,
short­
term,
and
chronic
(
non­
cancer)
aggregate
risks
are
low
and
not
of
concern.
Aggregate
cancer
risk
estimates
are
within
a
negligible
risk
range
°
EPA
has
risk
concerns
for
some
workers
who
mix,
load,
and/
or
apply
metiram
to
agricultural
sites,
and
workers
who
enter
treated
areas.

°
Chronic
risks
exceed
the
Agency's
level
of
concern
for
some
terrestrial
species.
Also,
there
is
a
potential
concern
for
acute
and
chronic
effects
on
come
listed
terrestrial
and
aquatic
endangered
species,
should
exposure
actually
occur.

Risk
Mitigation
To
address
assessed
risks
of
concern,
the
following
mitigation
measures
will
be
implemented:

°
Add
a
PF5
respirator
to
label
PPE
for
some
worker
scenarios:
mixer/
loaders
of
dry
flowables
for
aerial/
chemigation
applications;
airblast
applicators
to
apples;
and
flaggers,
°
Add
the
use
of
engineering
controls
to
labels
for
aerial
applicators
(
enclosed
cockpits),
°
Reduce
apple
pre­
bloom
maximum
application
rate
from
4.8
to
3.6
lbs
ai/
A,
°
Reduce
maximum
number
of
applications
for
apples
from
4
to
3
per
year,
°
Reduce
maximum
number
of
applications
for
potatoes
from
7
to
6
per
year,
°
Limit
the
number
of
applications
to
leatherleaf
ferns
to
1
per
week
and
10
per
year,
and
°
Metiram
use
on
roses
and
dust
and
wettable
powder
formulations
have
been
voluntarily
cancelled
prior
to
completion
of
the
RED.
Further,
as
a
result
of
the
voluntary
cancellation
of
the
dust
formulation
by
the
technical
registrant
and
risks
associated
with
this
formulation,
the
end­
use
registrant
has
requested
voluntary
cancellation
of
their
active
potato
seed
treatment
fungicide
product
registration.

Regulatory
Conclusion
The
Agency
has
determined
that
metiram
containing
products
are
eligible
for
reregistration
provided
that
the
risk
mitigation
measures
are
adopted
and
labels
are
amended
to
reflect
these
measures.

For
More
Information
4
Electronic
copies
of
the
Metiram
RED
and
all
supporting
documents
are
available
in
the
public
docket
OPP­
2005­
0177
located
on­
line
in
the
Federal
Docket
Management
System
(
FDMS)
at
http://
www.
regulations.
gov.

For
more
information
about
EPA's
pesticide
reregistration
program,
the
Metiram
RED,
or
reregistration
of
individual
products
containing
metiram,
please
contact
the
Special
Review
and
Reregistration
Division
(
7508C),
Office
of
Pesticide
Programs,
US
EPA,
Washington,
DC
20460,
telephone
703­
308­
8000.

For
information
about
the
health
effects
of
pesticides,
or
for
assistance
in
recognizing
and
managing
pesticide
poisoning
symptoms,
please
contact
the
National
Pesticide
Information
Center
(
NPIC).
Call
toll­
free
1­
800­
858­
7378,
from
6:
30
am
to
4:
30
am
Pacific
Time,
or
9:
30
am
to
7:
30
pm
Eastern
Standard
Time,
seven
days
a
week.
The
NPIC
internet
address
is
http://
npic.
orst.
edu.