Document ID: EPA-HQ-OPP-2005-0178-0011
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)

Maneb
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
maneb,
case
number
0642.

Regulatory
History
Maneb
was
first
registered
in
the
United
States
in
1962
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.
Maneb
is
a
member
of
the
ethylene
bisdithiocarbamate
(
EBDC)
group
of
fungicides,
which
includes
the
related
active
ingredients
mancozeb
and
metiram.
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
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.
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
maneb
and
other
EBDC
products
registered
on
the
above­
listed
food/
feed
crops.

The
Maneb
Registration
Standard
dated
August
22,
1986
required
additional
product
chemistry
data.
Addendum
No.
1
to
the
Maneb
Registration
Standard
dated
March
31,
1987
included
a
review
of
data
not
available
at
the
time
of
the
original
registration
standard
and
required
additional
product
chemistry
data.
A
comprehensive
Data­
Call­
In
(
DCI)
was
issued
April
1,
1987
to
all
registrants
of
maneb
addressing
product
chemistry
data
requirements.
The
Product
Chemistry
Chapter
of
the
Maneb
Registration
Standard
Update
dated
May
13,
1988
included
a
review
of
data
submitted
in
response
to
the
April
1987
DCI
with
regard
to
adequacy
in
fulfilling
product
chemistry
requirements.
A
Guidance
Document
for
maneb
was
issued
in
October
1988.
Product
chemistry
data
submitted
in
response
to
the
Guidance
Document
were
reviewed
in
the
Maneb
Registration
Standard
Update
dated
August
11,
1992,
and
additional
data
were
required
for
the
registration
of
maneb.

Uses
°
Maneb
is
used
on
a
wide
variety
of
food/
feed
crops,
including
fruit
and
nut
crops,
vegetable
crops,
field
and
forage
crops,
grapes,
field
crop
seeds,
and
others;
ornamental
plants
in
nurseries
and
greenhouses;
and
sod
farms.
There
are
no
residential
uses,
and
no
agricultural
uses
that
could
result
in
exposure
to
maneb
in
residential
settings.

°
Approximately
2.5
million
pounds
of
maneb
are
used
annually,
mostly
on
almonds,
lettuce,
peppers,
and
walnuts.

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

Health
Effects
°
Similar
to
other
EBDCs
and
ETU,
the
thyroid
is
the
target
organ
for
maneb.
Thyroid
effects
observed
in
multiple
studies
across
species
include
changes
in
clinical
chemistry
parameters
indicative
of
thyroid
toxicity,
increased
thyroid
weight,
follicular
(
thyroid)
cell
hyperplasia,
decreased
T
4
(
serum
thyroxin),
and
increased
incidence
of
diffuse
follicular
epithelial
hypertrophy/
hyperplasia.
Risks
3
°
Acute,
chronic,
and
cancer
dietary
(
food
only)
risk
from
maneb,
maneb­
derived
ETU,
and
ETU
from
all
sources
are
low
and
below
the
Agency's
level
of
concern.

°
The
drinking
water
exposure
assessment
for
maneb
addresses
concentrations
of
ETU
only,
since
maneb
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.

°
There
are
no
currently
registered
residential
uses
of
maneb.
The
only
potential
residential
exposure
to
maneb
is
from
residues
remaining
on
transplanted
turf
from
sod
farms.
The
reduced
application
rate
and/
or
extended
PHI,
combined
with
the
logistics
of
transplanting
turf
and
installation
restrictions,
effectively
reduced
the
potential
contribution
from
this
use
pattern
to
a
level
not
of
concern
to
the
Agency.

°
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
maneb
to
agricultural
sites
and
workers
who
enter
treated
areas.

°
Acute
and
chronic
risks
exceed
the
Agency's
level
of
concern
for
some
terrestrial
and
aquatic
species.
Also,
there
is
potential
concern
for
acute
and
chronic
effects
on
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:

Maneb­
All
Formulations
°
Sweet
Corn
­
Cancel
Use
°
Grapes
­
Cancel
Use
°
Apples
­
Cancel
Use
°
Kadota
Figs
­
Cancel
Use
°
Seed
Treatment
to
Rice
and
Peanuts
­
Cancel
Use
°
Oats
Seed
Treatment
­
Reduce
maximum
application
rate
from
0.0031lb
ai/
lb
seed
to
0.0021
lb
ai/
lb
seed
°
Almonds­
Reduce
maximum
seasonal
rate
from
25.6
to
19.2
lbs
ai/
acre/
season
and
retain
maximum
application
rate
of
6.4
lbs
ai/
acre
°
Sod
Farm
Turf
­
Reduce
maximum
application
rate
from
17.4
lbs
ai/
acre
to
8.7
lbs
ai/
acre,
limit
maximum
seasonal
rate
to
34.8
lbs
ai/
acre/
season
and
add
a
3
day
preharvest
interval.
Handlers
mixing/
loading
of
dry
flowables
and
liquids
for
aerial
or
chemigation
application,
add
a
PF5
Respirator.
4
°
Cut
Flowers
­
Limit
number
of
applications
per
year
to
20
°
Commercial
Potato
Seed­
Piece
Treatment
(
dust)
­
require
engineering
controls
(
e.
g.
dust
collector
equipment)

Maneb­
Wettable
Powder
Formulation
Only
°
Sod
Farm
Turf
­
Cancel
Use
°
Chemigation/
Aerial
Applications
­
Delete
Application
Method
°
For
mixing/
loading
all
remaining
uses
add
PF
5
Respirator.

Regulatory
Conclusion
The
Agency
has
determined
that
maneb
containing
products
are
eligible
for
reregistration
provided
that
the
risk
mitigation
measures
are
adopted
and
labels
are
amended
to
reflect
these
measures.
The
following
uses
of
maneb
are
not
eligible
for
reregistration
and
are
being
voluntarily
canceled
by
registrants
and
deleted
from
all
maneb
labels:
sweet
corn,
grapes,
apples,
kadota
figs,
and
seed
treatment
use
for
peanuts
and
rice.

For
More
Information
Electronic
copies
of
the
Maneb
RED
and
all
supporting
documents
are
available
in
the
public
docket
OPP­
2005­
0178
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
Maneb
RED,
or
reregistration
of
individual
products
containing
maneb,
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.