Document ID: EPA-HQ-OAR-2003-0017-0092
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-02-10T05:00Z

1
2003
NOMINATION
FOR
A
CRITICAL
USE
EXEMPTION
FOR
METHYL
BROMIDE
FROM
THE
UNITED
STATES
OF
AMERICA
 
Executive
Summary
 
This
document
constitutes
the
request
of
the
United
States
of
America
for
an
exemption
for
critical
uses
of
methyl
bromide
for
2005
and
2006
consistent
with
the
requirements
of
the
Montreal
Protocol
and
Decision
IX/
6.
The
United
States
is
firmly
committed
to
the
goals
of
the
Protocol,
evidenced
in
particular
by
the
strong
efforts
we
have
made
over
the
last
decade
to
phase
out
uses
of
methyl
bromide
where
it
has
been
feasible.
Over
that
time,
the
United
States
has
maintained
consumption
levels
lower
than
those
required
under
the
Protocol.
We
remain
fully
committed
to
seeking
alternatives
to
methyl
bromide
and
prioritizing
consideration
of
their
registration
in
the
context
of
their
overall
human
health
and
environmental
impact.

1.
Background
In
1997,
the
Parties
to
the
Montreal
Protocol
adjusted
Article
2H
of
the
Protocol,
and
agreed
to
accelerate
the
reduction
in
the
controlled
production
and
consumption
of
methyl
bromide.
This
adjustment
included
a
provision
calling
for
a
phaseout
of
methyl
bromide
by
the
year
2005
"
save
to
the
extent
that
the
Parties
decide
to
permit
the
level
of
production
or
consumption
that
is
necessary
to
satisfy
uses
agreed
by
them
to
be
critical
uses."
At
the
same
time,
the
Parties
adopted
decision
IX/
6,
the
critical
use
exemption
decision,
which
laid
out
the
terms
under
which
critical
use
exemptions
under
Article
2H
would
be
granted.

2.
Criteria
for
Critical
Uses
under
the
Montreal
Protocol
In
crafting
Decision
IX/
6
outlining
the
criteria
for
a
critical
use
exemption,
the
Parties
recognized
the
significant
differences
between
methyl
bromide
uses
and
uses
of
other
ozonedepleting
chemicals
previously
given
scrutiny
under
the
Protocol's
distinct
and
separate
Essential
Use
exemption
process.
The
United
States
believes
that
it
is
vitally
important
for
the
MBTOC
to
take
into
account
the
significant
differences
between
the
critical
use
exemption
and
the
essential
use
exemption
in
the
review
of
all
methyl
bromide
critical
use
nominations.

During
the
debate
leading
up
to
the
adoption
of
the
critical
use
exemption
Decision
IX/
6,
an
underlying
theme
voiced
by
many
countries
was
that
the
Parties
wanted
to
phase
out
methyl
bromide,
and
not
agriculture.
This
theme
was
given
life
in
various
provisions
of
the
critical
use
exemption,
and
in
the
differences
in
approach
taken
between
the
critical
use
exemption
and
the
essential
use
exemption.
Those
differences
are
outlined
below.

The
Protocol's
negotiated
criteria
for
the
Critical
Use
Exemptions
for
methyl
bromide
are
much
different
from
the
criteria
negotiated
for
"
Essential
Uses"
for
other
chemicals:
2
Under
the
Essential
Use
provisions,
in
order
to
even
be
considered
for
an
exemption,
it
was
necessary
for
each
proposed
use
to
be
"
critical
for
health,
safety
or
the
functioning
of
society."
This
high
threshold
differs
significantly
from
the
criteria
established
for
the
methyl
bromide
Critical
Use
exemption.
Indeed,
for
methyl
bromide,
the
Parties
left
it
solely
to
the
nominating
governments
to
find
that
the
absence
of
methyl
bromide
would
create
a
significant
market
disruption.

For
all
crops
covered
in
the
U.
S.
nomination,
the
United
States
has
determined
that
the
level
of
methyl
bromide
being
requested
is
critical
to
ensuring
that
there
is
no
significant
market
disruption.
This
determination
is
based
on
a
detailed
analysis
of
technical
and
economic
feasibility
factors
that
are
described
in
greater
detail
in
each
of
the
sector
chapters.

In
the
case
of
methyl
bromide,
the
Parties
recognized
many
agricultural
fumigants
were
inherently
toxic,
and
therefore
there
was
a
strong
desire
not
to
replace
one
environmentally
problematic
chemical
with
another
even
more
damaging.

The
Critical
Use
exemption
language
explicitly
requires
that
an
alternative
should
not
only
be
technically
and
economically
feasible,
it
must
also
be
acceptable
from
the
standpoint
of
health
and
environment.
This
is
particularly
important
given
the
fact
that
most
chemical
alternatives
to
methyl
bromide
are
highly
toxic,
and
can
involve
threats
to
human
health
or
the
environment
that
are
greater
than
the
threats
posed
by
methyl
bromide.

In
the
case
of
methyl
bromide,
the
Parties
recognized
that
evaluating,
commercializing
and
securing
national
approval
of
alternatives
and
substitutes
is
a
lengthy
process.

In
fact,
even
after
an
alternative
is
tested
and
found
to
work
against
some
pests
in
a
controlled
setting,
adequate
testing
in
large­
scale
commercial
operations
can
take
many
cropping
seasons
before
the
viability
of
the
alternative
can
be
adequately
assessed
from
the
standpoint
of
the
climate
and
soil
for
various
potential
users.
In
addition,
the
process
of
securing
national
and
subnational
approval
of
alternatives
may
require
extensive
analysis
of
environmental
consequences
and
toxicology.
The
average
time
for
the
national
review
of
scientific
information
in
support
of
a
new
pesticide,
starting
from
the
date
of
submission
to
registration,
is
approximately
38
months.
In
most
cases,
the
company
submitting
the
information
has
spent
approximately
7­
10
years
developing
the
epidemiological
and
other
environmental
data
necessary
to
support
the
registration
request.

The
Parties
to
the
Protocol
recognized
that
unlike
other
chemicals
controlled
under
the
Montreal
Protocol,
the
use
of
methyl
bromide
and
available
alternatives
could
be
site
specific
and
must
take
into
account
the
particular
needs
of
the
user.

The
Essential
Use
exemption
largely
assumed
that
an
alternative
used
in
one
place
could,
if
approved
by
the
government,
be
used
everywhere.
Parties
clearly
understood
that
this
was
not
the
case
with
methyl
bromide
because
of
the
large
number
of
variables
involved,
such
as
crop
type,
soil
types,
pest
pressure
and
local
climate.
That
is
why
the
methyl
bromide
Critical
Use
exemption
calls
for
an
examination
of
the
feasibility
of
the
alternative
from
the
standpoint
of
the
user,
and
in
the
context
of
the
specific
circumstances
of
the
nomination,
including
use
and
geographic
location.
In
order
to
effectively
implement
this
last,
very
important
provision,
we
believe
it
is
critical
for
3
MBTOC
reviewers
to
understand
the
unique
nature
of
U.
S.
agriculture,
as
well
as
U.
S.
efforts
to
minimize
the
use
of
methyl
bromide,
to
research
alternatives,
and
to
register
alternatives
for
methyl
bromide.

3.
Overview
of
U.
S.
Agriculture
The
United
States
is
fortunate
to
have
a
large
land
expanse,
productive
soils
and
a
variety
of
favorable
agricultural
climates.
These
factors
contribute
to
and
enable
the
U.
S.
to
be
a
uniquely
large
and
productive
agricultural
producer.
Indeed,
the
size
and
scope
of
farming
in
the
U.
S.
is
different
than
in
most
countries.
Specifically,
in
2001,
U.
S.
farm
land
totaled
381
million
hectares,
a
land
mass
larger
than
the
entire
size
of
many
entire
countries.
There
were
2.16
million
farms,
with
average
farm
size
across
all
farms
of
176
hectares
(
approximately
10
times
larger
than
average
farm
sizes
in
the
European
Union).
The
availability
of
land
and
the
fact
that
so
many
U.
S.
regions
are
conducive
to
outdoor
cultivation
of
fruits
and
vegetables,
has
had
an
important
influence
on
the
way
agriculture
has
developed.
Specifically,
these
factors
have
meant
that
greenhouse
production
has
generally
proven
to
be
very
costly
(
in
relative
terms)
and
has
as
a
consequence,
been
limited.

Other
factors
also
affected
the
general
development
of
agriculture
in
the
U.
S.
While
land
for
farming
is
widely
available,
labor
is
generally
more
expensive
and
less
plentiful.
As
a
result,
the
U.
S.
has
developed
a
unique
brand
of
highly
mechanized
farming
practices
that
are
highly
reliant
on
pesticides
such
as
methyl
bromide
and
other
non­
labor
inputs.
The
extent
of
mechanization
and
reliance
on
non­
labor
inputs
can
be
best
demonstrated
by
noting
the
very
low
levels
of
labor
inputs
on
U.
S.
farms:
in
2001,
only
2.05
million
self­
employed
and
unpaid
workers
operated
the
2.16
million
U.
S.
farms,
with
seasonal
or
supplemental
help
from
less
than
1
million
hired
workers.

U.
S.
agriculture
is
also
unique
in
terms
of
the
broad
range
of
crops
produced.
For
example,
the
fruit
and
vegetable
sector,
the
agricultural
sector
most
reliant
on
methyl
bromide,
is
diverse,
and
includes
production
of
107
separate
fruit
and
vegetable
commodities
or
groups
of
commodities.
With
this
diversity,
however,
has
come
a
large
number
of
pest
problems
that
methyl
bromide
has
proven
uniquely
able
to
address.

Finally,
the
above
factors
have
contributed
to
a
harvest
of
commodities
that
has
enabled
the
U.
S.
to
meet
not
only
its
needs,
but
also
the
needs
of
many
other
countries.
The
U.
S.
produced
88.3
million
metric
tonnes
of
fruits
and
vegetables
in
2001,
up
10
percent
from
1990.
At
the
same
time,
the
land
planted
in
fruits
and
vegetables
has
remained
stable,
and
individual
farm
size
has
increased
as
the
number
of
farms
has
fallen.
The
related
yield
increases
per
land
area
are
almost
exclusively
related
to
non­
labor
inputs,
like
the
adoption
of
new
varieties,
and
the
application
of
new
production
practices,
including
plastic
mulches,
row
covers,
high­
density
planting,
more
effective
pesticide
sprays,
and
drip
irrigation,
as
well
as
increased
water
irrigation
practices.
Optimization
of
yields
through
these
and
other
scientific
and
mechanized
practices
make
U.
S.
agricultural
output
very
sensitive
to
changes
in
inputs.
Therefore,
as
evidenced
by
the
U.
S.
nomination
for
critical
uses
of
methyl
bromide
for
specific
crops,
the
phaseout
of
methyl
bromide
can
have
a
very
significant
impact
on
both
the
technical
and
economic
viability
of
production
of
certain
crops
in
certain
areas.
4
4.
U.
S.
Consideration/
Preparation
of
the
Critical
Use
Exemption
Proposal
Work
on
the
U.
S.
critical
use
exemption
process
began
in
early
2001.
At
that
time,
the
U.
S.
Environmental
Protection
Agency
(
US
EPA)
initiated
open
meetings
with
stakeholders
both
to
inform
them
of
the
Protocol
requirements,
and
to
understand
the
issues
being
faced
in
researching
alternatives
to
methyl
bromide.
During
those
meetings,
which
were
attended
by
State
and
association
officials
representing
literally
thousands
of
methyl
bromide
users,
the
provisions
of
the
critical
use
exemption
Decision
IX/
6
were
reviewed
in
detail,
and
questions
were
taken.
The
feedback
from
these
initial
meetings
led
to
efforts
by
the
United
States
to
have
the
Protocol
Parties
establish
international
norms
for
the
details
to
be
in
submissions
and
to
facilitate
standardization
for
a
fair
and
adequate
review.
These
efforts
culminated
in
decision
XIII/
11
which
calls
for
specific
information
to
be
presented
in
the
nomination.

Upon
return
from
the
Sri
Lanka
meeting
of
the
Parties,
the
U.
S.
took
a
three
track
approach
to
the
critical
use
process.
First,
we
worked
to
develop
a
national
application
form
that
would
ensure
that
we
had
the
information
necessary
to
answer
all
of
the
questions
posed
in
decision
XIII/
11.
At
the
same
time,
we
initiated
sector
specific
meetings.
This
included
meetings
with
representatives
of
growers
across
the
United
States
to
discuss
their
specific
issues,
and
to
enable
them
to
understand
the
newly
detailed
requirements
of
the
critical
use
application.
These
sector
meetings
allowed
us
to
fine
tune
the
application
so
we
could
submit
the
required
information
to
the
MBTOC
in
a
meaningful
fashion.

Finally,
and
concurrent
with
our
preparation
phase,
we
developed
a
plan
to
ensure
a
robust
and
timely
review
of
any
and
all
critical
use
applications
we
might
receive.
This
involved
the
assembly
of
more
than
45
PhDs
and
other
qualified
reviewers
with
expertise
in
both
biological
and
economic
issues.
These
experts
were
divided
into
interdisciplinary
teams
to
enable
primary
and
secondary
reviewers
for
each
application/
crop.
As
a
consequence,
each
nomination
received
by
the
U.
S.
was
reviewed
by
two
separate
teams.
In
addition,
the
review
of
these
interdisciplinary
teams
was
put
to
a
broader
review
of
experts
on
all
other
sector
teams
to
enable
a
third
look
at
the
information,
and
to
ensure
consistency
in
review
between
teams.
The
result
was
a
thorough
evaluation
of
the
merits
of
each
request.
A
substantial
portion
of
requests
did
not
meet
the
criteria
of
decision
IX/
6,
and
a
strong
case
for
those
that
did
meet
the
criteria
has
been
included.

Following
our
technical
review,
discussions
were
held
with
senior
risk
management
personnel
of
the
U.
S.
government
to
go
over
the
recommendations
and
put
together
a
draft
package
for
submission
to
the
parties.
As
a
consequence
of
all
of
this
work,
it
is
safe
to
say
that
each
of
the
sector
specific
nominations
being
submitted
is
the
work
of
well
over
150
experts
both
in
and
outside
of
the
U.
S.
government.

5.
Overview
of
the
2003
Critical
Use
Exemption
Nomination
The
U.
S.
nomination
for
a
critical
use
exemption
is
for
the
following
sixteen
(
16)
crops/
uses:
commodity
storage,
curcurbit,
eggplant,
food
processing,
forest
tree
seedling
nursery,
ginger,
nursery
seed
bed
trays,
orchard
nursery,
orchard
replant,
ornamental
nursery,
pepper,
strawberry,
strawberry
nursery,
sweet
potato,
tomato,
and
turfgrass.
The
total
amount
of
methyl
bromide
5
nominated
by
the
U.
S.
for
these
uses
is
9,920,965
kilograms
for
2005,
and
9,445,360
kilograms
for
2006.
The
detailed
information
supporting
the
U.
S.
nomination
for
each
crop
or
use
is
covered
in
an
individual
chapter
of
the
U.
S.
nomination.

In
preparing
this
nomination,
we
consulted
with
the
MBTOC
co­
chair,
and
we
have
made
an
effort
to
tailor
this
package
to
the
needs
of
the
review
group.
Specifically,
in
order
to
enable
MBTOC
to
split
up
the
nomination
in
a
manner
that
would
allow
for
sectoral
teams
to
review
individual
crops,
we
have
prepared
stand
alone
chapters
that
incorporate
into
each
chapter
much
of
the
relevant
material
that
is
included
in
this
Executive
Summary.
We
apologize
for
the
redundancy
that
this
may
have
brought
about,
but
we
wanted
to
ensure
that
this
important
information
was
included
in
each
relevant
section.

6.
Minimizing
Use/
Emissions
of
Methyl
Bromide
in
the
United
States/
Stockpiles
In
accordance
with
the
criteria
of
the
critical
use
exemption,
we
will
now
describe
ways
in
which
we
strive
to
minimize
use
and
emissions
of
methyl
bromide.
While
each
sector
based
nomination
includes
information
on
this
topic,
we
thought
it
would
be
useful
to
provide
some
general
information
that
is
applicable
to
most
methyl
bromide
uses
in
the
country
The
use
of
methyl
bromide
in
the
United
States
is
minimized
in
several
ways.
First,
because
of
its
toxicity,
methyl
bromide
is
regulated
as
a
restricted
use
pesticide
in
the
United
States.
As
a
consequence,
methyl
bromide
can
only
be
used
by
certified
applicators
who
are
trained
at
handling
these
hazardous
pesticides.
In
practice,
this
means
that
methyl
bromide
is
applied
by
a
limited
number
of
very
experienced
applicators
with
the
knowledge
and
expertise
to
minimize
dosage
to
the
lowest
level
possible
to
achieve
the
needed
results.
In
keeping
with
both
local
requirements
to
avoid
"
drift"
of
methyl
bromide
into
inhabited
areas,
as
well
as
to
preserve
methyl
bromide
and
keep
related
emissions
to
the
lowest
level
possible,
methyl
bromide
is
machine
injected
into
soil
to
specific
depths.
In
addition,
as
methyl
bromide
has
become
more
scarce,
users
in
the
United
States
have,
where
possible,
experimented
with
different
mixes
of
methyl
bromide
and
chloropicrin.
Specifically,
in
the
early
1990s,
methyl
bromide
was
typically
sold
and
used
in
methyl
bromide
mixtures
made
up
of
98%
methyl
bromide
and
2%
chloropicrin,
with
the
chloropicrin
being
included
solely
to
give
the
chemical
a
smell
enabling
those
in
the
area
to
be
alerted
if
there
was
a
risk.
However,
with
the
outset
of
very
significant
controls
on
methyl
bromide,
users
have
been
experimenting
with
significant
increases
in
the
level
of
chloropicrin
and
reductions
in
the
level
of
methyl
bromide.
While
these
new
mixtures
have
generally
been
effective
at
controlling
target
pests,
it
must
be
stressed
that
the
long
term
efficacy
of
these
mixtures
is
unknown.
Reduced
methyl
bromide
concentrations
in
mixtures,
more
mechanized
soil
injection
techniques,
and
the
extensive
use
of
tarps
to
cover
land
treated
with
methyl
bromide
has
resulted
in
reduced
emissions
and
an
application
rate
that
we
believe
is
among
the
lowest
in
the
world.

In
terms
of
compliance,
in
general,
the
United
States
has
used
a
combination
of
tight
production
and
import
controls,
and
the
related
market
impacts
to
ensure
compliance
with
the
Protocol
requirements
on
methyl
bromide.
Indeed,
over
the
last
few
years,
the
price
of
methyl
bromide
has
increased
substantially.
As
Chart
1
below
demonstrates,
the
application
of
these
policies
has
led
to
a
more
rapid
U.
S.
phasedown
in
methyl
bromide
consumption
than
required
under
6
the
Protocol.
This
accelerated
phasedown
on
the
consumption
side
may
also
have
enabled
methyl
bromide
production
to
be
stockpiled
to
some
extent
to
help
mitigate
the
potentially
significant
impacts
associated
with
the
Protocol's
2003
and
2004
70%
reduction.
We
are
currently
uncertain
as
to
the
exact
quantity
of
existing
stocks
going
into
the
2003
season
that
may
be
stockpiled
in
the
U.
S.
We
currently
believe
that
the
limited
existing
stocks
are
likely
to
be
depleted
during
2003
and
2004.
This
factor
is
reflected
in
our
requests
for
2005
and
beyond.

CHART
1.

At
the
same
time
we
have
made
efforts
to
reduce
emissions
and
use
of
methyl
bromide,
we
have
also
made
strong
efforts
to
find
alternatives
to
methyl
bromide.
The
section
that
follows
discusses
those
efforts.

7.
U.
S.
Efforts
to
Find,
Register
and
Commercialize
Alternatives
to
Methyl
Bromide
Over
the
past
ten
years,
the
United
States
has
committed
significant
financial
and
technical
resources
to
the
goal
of
seeking
alternatives
to
methyl
bromide
that
are
technically
and
economically
feasible
to
provide
pest
protection
for
a
wide
variety
of
crops,
soils,
and
pests,
while
also
being
acceptable
in
terms
of
human
health
and
environmental
impacts.
The
U.
S.
pesticide
registration
program
has
established
a
rigorous
process
to
ensure
that
pesticides
registered
for
use
in
the
United
States
do
no
present
an
unreasonable
risk
of
health
or
environmental
harm.
Within
the
program,
we
have
given
the
highest
priority
to
rapidly
reviewing
methyl
bromide
alternatives,
while
maintaining
our
high
domestic
standard
of
environmental
protection.
A
number
of
alternatives
have
already
been
registered
for
use,
and
several
additional
promising
alternatives
are
under
review
at
this
time.
Our
1994
199
5
1996
1997
1998
199
9
2000
2001
2002
2003
2004
2005
0%
25%
50%
75%
100%

Percent
of
U.
S.
Consumption
Baseline
Phaseout
Schedule
Actual
Consumption
U.
S.
Methyl
Bromide
Consumption
and
Phaseout
Schedule
7
research
efforts
to
find
new
alternatives
to
methyl
bromide
and
move
them
quickly
toward
registration
and
commercialization
have
allowed
us
to
make
great
progress
over
the
last
decade
in
phasing
out
many
uses
of
methyl
bromide.
However,
these
efforts
have
not
provided
effective
alternatives
for
all
crops,
soil
types
and
pest
pressures,
and
we
have
accordingly
submitted
a
critical
use
nomination
to
address
these
limited
additional
needs.

Research
Program
When
the
United
Nations,
in
1992,
identified
methyl
bromide
as
a
chemical
that
contributes
to
the
depletion
of
the
ozone
layer
and
the
Clean
Air
Act
committed
the
U.
S.
to
phase
out
the
use
of
methyl
bromide,
the
U.
S.
Department
of
Agriculture
(
USDA)
initiated
a
research
program
to
find
viable
alternatives.
Finding
alternatives
for
agricultural
uses
is
extremely
complicated
compared
to
replacements
for
other,
industrially
used
ozone­
depleting
substances
because
many
factors
affect
the
efficacy
such
as:
crop
type,
climate,
soil
type,
and
target
pests,
which
change
from
region
to
region
and
among
localities
within
a
region.

Through
2002,
the
USDA
Agricultural
Research
Service
(
ARS)
alone
has
spent
US$
135.5
million
to
implement
an
aggressive
research
program
to
find
alternatives
to
methyl
bromide
(
see
Table
1
below).
Through
the
Cooperative
Research,
Education
and
Extension
Service,
USDA
has
provided
an
additional
$
11.4
million
since
1993
to
state
universities
for
alternatives
research
and
outreach.
This
federally
supported
research
is
a
supplement
to
extensive
sector
specific
private
efforts,
and
all
of
this
research
is
very
well
considered.
Specifically,
the
phaseout
challenges
brought
together
agricultural
and
forestry
leaders
from
private
industry,
academia,
state
governments,
and
the
federal
government
to
assess
the
problem,
formulate
priorities,
and
implement
research
directed
at
providing
solutions
under
the
USDA's
Methyl
Bromide
Alternatives
program.
The
ARS
within
USDA
has
22
national
programs,
one
of
which
is
the
Methyl
Bromide
Alternatives
program
(
Select
Methyl
Bromide
Alternatives
at
this
web
site:
http://
www.
nps.
ars.
usda.
gov
).
The
resulting
research
program
has
taken
into
account
these
inputs,
as
well
as
the
extensive
private
sector
research
and
trial
demonstrations
of
alternatives
to
methyl
bromide.
While
research
has
been
undertaken
in
all
sectors,
federal
government
efforts
have
been
based
on
the
input
of
experts
as
well
as
the
fact
that
nearly
80
percent
of
preplant
methyl
bromide
soil
fumigation
is
used
in
a
limited
number
of
crops.
Accordingly,
much
of
the
federal
government
pre­
plant
efforts
have
focused
on
strawberries,
tomatoes,
ornamentals,
peppers
and
nursery
crops,
(
forest,
ornamental,
strawberry,
pepper,
tree,
and
vine),
with
special
emphasis
on
tomatoes
in
Florida
and
strawberries
in
California
as
model
crops.
8
Table
1:
Methyl
Bromide
Alternatives
Research
Funding
History
Year
Expenditures
by
the
U.
S.
Department
of
Agriculture
(
US$
Million)

1993
$
7.255
1994
$
8.453
1995
$
13.139
1996
$
13.702
1997
$
14.580
1998
$
14.571
1999
$
14.380
2000
$
14.855
2001
$
16.681
2002
$
17.880
The
USDA/
ARS
strategy
for
evaluating
possible
alternatives
is
to
first
test
the
approaches
in
controlled
experiments
to
determine
efficacy,
then
testing
those
that
are
effective
in
field
plots.
The
impact
of
the
variables
that
affect
efficacy
is
addressed
by
conducting
field
trials
at
multiple
locations
with
different
crops
and
against
various
diseases
and
pests.
Alternatives
that
are
effective
in
field
plots
are
then
tested
in
field
scale
validations,
frequently
by
growers
in
their
own
fields.
University
scientists
are
also
participants
in
this
research.
Research
teams
that
include
ARS
and
university
scientists,
extension
personnel,
and
grower
representatives
meet
periodically
to
evaluate
research
results
and
plan
future
trials.

Research
results
submitted
with
the
CUE
request
packages
(
including
published,
peerreviewed
studies
by
(
primarily)
university
researchers,
university
extension
reports,
and
unpublished
studies)
include
trials
conducted
to
assess
the
effectiveness
of
the
most
likely
chemical
and
nonchemical
alternatives
to
methyl
bromide,
including
some
potential
alternatives
that
are
not
currently
included
in
the
MBTOC
list.

As
demonstrated
by
the
table
above,
U.
S.
efforts
to
research
alternatives
for
methyl
bromide
have
been
substantial,
and
they
have
been
growing
in
size
as
the
phaseout
has
approached.
The
United
States
is
committed
to
sustaining
these
research
efforts
in
the
future
to
continue
to
aggressively
search
for
technically
and
economically
feasible
alternatives
to
methyl
bromide.
We
are
also
committed
to
continuing
to
share
our
research,
and
enable
a
global
sharing
of
experience.
Toward
that
end,
for
the
past
several
years,
key
U.
S.
government
agencies
have
collaborated
with
industry
to
host
an
annual
conference
on
alternatives
to
methyl
bromide.
This
conference,
the
Methyl
Bromide
Alternatives
Outreach
(
MBAO),
has
become
the
premier
forum
for
researchers
and
others
to
discuss
scientific
findings
and
progress
in
this
field.

While
the
U.
S.
government's
role
to
find
alternatives
is
primarily
in
the
research
arena,
we
know
that
research
is
only
one
step
in
the
process.
As
a
consequence,
we
have
also
invested
9
significantly
in
efforts
to
register
alternatives,
as
well
as
efforts
to
support
technology
transfer
and
education
activities
with
the
private
sector.

Registration
Program
The
United
States
has
one
of
the
most
rigorous
programs
in
the
world
for
safeguarding
human
health
and
the
environment
from
the
risks
posed
by
pesticides.
While
we
are
proud
of
our
efforts
in
this
regard,
related
safeguards
do
not
come
without
a
cost
in
terms
of
both
money
and
time.
Because
the
registration
process
is
so
rigorous,
it
can
take
a
new
pesticide
several
years
(
3­
5)
to
get
registered
by
EPA.
It
also
takes
a
large
number
of
years
to
perform,
draft
results
and
deliver
the
large
number
of
health
and
safety
studies
that
are
required
for
registration.

The
U.
S.
Environmental
Protection
Agency
regulates
the
use
of
pesticides
under
two
major
federal
statutes:
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
and
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
both
significantly
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
Under
FIFRA,
EPA
registers
(
licenses)
pesticides
provided
its
use
does
not
pose
unreasonable
risks
to
humans
or
the
environment.
Under
FFDCA,
the
Agency
is
responsible
for
setting
tolerances
(
maximum
permissible
residue
levels)
for
any
pesticide
used
on
food
or
animal
feed.
With
the
passage
of
FQPA,
the
Agency
is
required
to
establish
a
single,
health­
based
standard
for
pesticides
used
on
food
crops
and
to
determine
that
establishment
of
a
tolerance
will
result
in
a
"
reasonable
certainty
of
no
harm"
from
aggregate
exposure
to
the
pesticide.

The
process
by
which
EPA
examines
the
ingredients
of
a
pesticide
to
determine
if
they
are
safe
is
called
the
registration
process.
The
Agency
evaluates
the
pesticide
to
ensure
that
it
will
not
have
any
adverse
effects
on
humans,
the
environment,
and
non­
target
species.
Applicants
seeking
pesticide
registration
are
required
to
submit
a
wide
range
of
health
and
ecological
effects
toxicity
data,
environmental
fate,
residue
chemistry
and
worker/
bystander
exposure
data
and
product
chemistry
data.
A
pesticide
cannot
be
legally
used
in
the
United
States
if
it
has
not
been
registered
by
EPA,
unless
it
has
an
exemption
from
regulation
under
FIFRA.

Since
1997,
the
Agency
has
made
the
registration
of
alternatives
to
methyl
bromide
the
highest
registration
priority.
Because
the
Agency
currently
has
more
applications
pending
in
its
review
than
the
resources
to
evaluate
them,
EPA
prioritizes
the
applications
in
its
registration
queue.
By
virtue
of
being
the
top
registration
priority,
methyl
bromide
alternatives
enter
the
science
review
process
as
soon
as
EPA
receives
the
application
request.
The
average
processing
time
for
a
new
active
ingredient,
from
date
of
submission
to
issuance
of
a
registration
decision,
is
approximately
38
months.
In
most
cases,
the
registrant
(
the
pesticide
applicant)
has
spent
approximately
7­
10
years
developing
the
data
necessary
to
support
registration.

As
one
incentive
for
the
pesticide
industry
to
develop
alternatives
to
methyl
bromide,
the
Agency
has
worked
to
reduce
the
burdens
on
data
generation,
to
the
extent
feasible
while
still
ensuring
that
the
Agency's
registration
decisions
meet
the
Federal
statutory
safety
standards.
Where
appropriate
from
a
scientific
standpoint,
the
Agency
has
refined
the
data
requirements
for
a
given
pesticide
application,
allowing
a
shortening
of
the
research
and
development
process
for
the
methyl
bromide
alternative.
Furthermore,
Agency
scientists
routinely
meet
with
prospective
methyl
10
bromide
alternative
applicants,
counseling
them
through
the
pre­
registration
process
to
increase
the
probability
that
the
data
is
done
right
the
first
time
and
rework
delays
are
minimized
The
Agency
has
also
co­
chaired
the
USDA/
EPA
Methyl
Bromide
Alternatives
Work
Group
since
1993
to
help
coordinate
research,
development
and
the
registration
of
viable
alternatives.
The
work
group
conducted
six
workshops
in
Florida
and
California
(
states
with
the
highest
use
of
methyl
bromide)
with
growers
and
researchers
to
identify
potential
alternatives,
critical
issues,
and
grower
needs
covering
the
major
methyl
bromide
dependent
crops
and
post
harvest
uses.

This
coordination
has
resulted
in
key
registration
issues
(
such
as
worker
and
bystander
exposure
through
volatilization,
township
caps
and
groundwater
concerns)
being
directly
addressed
through
USDA's
Agricultural
Research
Service's
$
13.5
million
per
year
research
program
conducted
at
more
than
20
field
evaluation
facilities
across
the
country.
Also
EPA's
participation
in
the
evaluation
of
research
grant
proposals
submitted
to
the
USDA's
Cooperative
State
Research,
Education,
and
Extension
Service
methyl
bromide
alternatives
research
program
of
US$
2.5
million
per
year
has
further
ensured
that
critical
registration
issues
are
being
addressed
by
the
research
community.

Since
1997,
EPA
has
registered
the
following
chemical/
use
combinations
as
part
of
its
commitment
to
expedite
the
review
of
methyl
bromide
alternatives:

1999:
Pebulate
to
control
weeds
in
tomatoes
2000:
Phosphine
to
control
insects
in
stored
commodities
2001:
Indian
Meal
Moth
Granulosis
Virus
to
control
Indian
meal
moth
in
stored
grains
2001:
Terrazole
to
control
pathogens
in
tobacco
float
beds
2001:
Telone
applied
through
drip
irrigation
­
all
crops
2002:
Halosulfuron­
methyl
to
control
weeds
in
melons
and
tomatoes
EPA
is
currently
reviewing
several
additional
applications
for
registration
as
methyl
bromide
alternatives,
with
several
registration
eligibility
decisions
expected
within
the
next
year,
including:

 
Iodomethane
as
a
pre­
plant
soil
fumigant
for
various
crops
 
Fosthiazate
as
a
pre­
plant
nematocide
for
tomatoes
 
Sulfuryl
fluoride
as
a
post­
harvest
fumigant
for
stored
commodities
 
Trifloxysulfuron
sodium
as
a
pre­
plant
herbicide
for
tomatoes
 
Dazomet
as
a
pre­
plant
soil
fumigant
for
strawberries
and
tomatoes
Again,
while
these
activities
appear
promising,
it
must
be
noted
that
issues
related
to
toxicity,
ground
water
contamination,
and
the
release
of
air
pollutants
may
pose
significant
problems
with
respect
to
some
alternatives
that
may
lead
to
use
restrictions
since
many
of
the
growing
regions
are
in
sensitive
areas
such
as
those
in
close
proximity
to
schools
and
homes.
Ongoing
research
on
alternate
fumigants
is
evaluating
ways
to
reduce
emission
under
various
application
regimes
and
examining
whether
commonly
used
agrochemicals,
such
as
fertilizers
and
nitrification
inhibitors,
could
be
used
to
rapidly
degrade
soil
fumigants.
For
example,
if
registration
of
iodomethane
or
11
another
alternative
occurs
in
the
near
future,
commercial
availability
and
costs
will
be
factors
that
must
be
taken
into
consideration.

It
must
be
emphasized,
however,
that
finding
potential
alternatives,
and
registering
those
alternatives
is
not
the
end
of
the
story.
Those
alternatives
must
be
trialed
by
users
and
must
be
finally
adopted,
which
takes
time.
Allowing
for
users
to
trial
alternatives,
so
farmers
can
adopt
them,
also
involves
time.
As
noted
by
TEAP,
a
specific
alternative,
once
available
may
take
two
or
three
cropping
seasons
of
use
before
efficacy
can
be
determined
in
the
specific
circumstance
of
the
user.
In
an
effort
to
reduce
related
time
frames,
the
United
States
government
has
also
been
involved
in
these
steps
by
promoting
technology
transfer,
experience
transfer,
and
private
sector
training.

8.
Conclusion
On
the
basis
of
an
exhaustive
review
of
a
large,
multi­
disciplinary
team
of
sector
and
general
agricultural
experts,
we
have
determined
that
the
TEAP
listed
potential
alternatives
for
the
specific
crops
and
areas
covered
in
this
nomination
are
not
currently
technically
or
economically
viable
from
the
standpoint
of
United
States
growers
covered
by
this
exemption
request.
We
have
also
determined
that
the
absence
of
methyl
bromide
for
the
nominated
uses
will
result
in
a
significant
market
disruption
to
the
effected
sectors.
We
have
and
continue
to
expend
significant
efforts
to
find
and
commercialize
alternatives,
and
that
potential
alternatives
to
the
use
of
methyl
bromide
for
many
important
uses
are
under
investigation
and
may
be
on
the
horizon.
Based
on
this
analysis,
we
believe
those
requests
included
in
this
nomination
meet
the
criteria
set
out
by
the
Parties
in
Decision
IX/
6.

9.
Policy
Issues
Associated
with
this
Nomination
a.
Initial
Nomination:
We
wish
to
note,
at
this
time,
that
the
U.
S.
submission
contained
in
this
document
constitutes
an
initial
request
for
an
exemption
from
the
methyl
bromide
phaseout.
We
call
this
an
initial
request,
because,
consistent
with
related
decisions,
Parties
may
submit
additional
requests
next
year
for
2005
and
beyond
if
further
review
indicates
that
important
uses
were
left
out
of
the
initial
nomination,
or
initially
projected
need
was
underestimated.

b.
Request
for
Aggregate
Exemption
for
All
Covered
Methyl
Bromide
Uses:
As
mandated
by
Decision
XIII/
11,
the
nomination
information
that
is
being
submitted
with
this
package
includes
information
requested
on
historic
use
and
estimated
need
in
individual
sectors.
That
said,
we
note
our
agreement
with
past
MBTOC
and
TEAP
statements
which
stress
the
dynamic
nature
of
agricultural
markets,
uncertainty
of
specific
production
of
any
one
crop
in
any
specific
year,
the
difficulty
of
projecting
several
years
in
advance
what
pest
pressures
might
prevail
on
a
certain
crop,
and,
the
difficulty
of
estimating
what
a
particular
market
for
a
specific
crop
might
look
like
in
a
future
year.
We
also
concur
with
the
MBTOC's
fear
that
countries
that
have
taken
significant
efforts
to
reduce
methyl
bromide
use
and
emissions
through
dilution
with
chloropicrin
may
be
experiencing
only
short
term
efficacy
in
addressing
pest
problems.
On
the
basis
of
those
factors,
we
urge
the
MBTOC
and
the
TEAP
to
follow
the
precedent
established
under
the
essential
use
exemption
process
for
Metered
Dose
Inhalers
(
MDIs)
in
two
key
areas.
12
First,
because
of
uncertainties
in
both
markets
and
the
future
need
for
individual
active
moieties
of
drugs,
the
TEAP
has
never
provided
a
tonnage
limit
for
each
of
the
large
number
of
active
moieties
found
in
national
requests
for
a
CFC
essential
use
exemption
for
MDIs,
but
has
instead
recommended
an
aggregate
tonnage
exemption
for
national
use.
This
has
been
done
with
an
understanding
that
the
related
country
will
ensure
that
the
tonnage
approved
for
an
exemption
will
be
used
solely
for
the
group
of
active
moieties/
MDIs
that
have
been
granted
the
exemption.
We
believe
that
the
factors
of
agricultural
uncertainty
surrounding
both
pest
pressures
in
future
year
crops,
pest
pressures,
and
efficacy
of
reduced
methyl
bromide
application
provide
an
even
stronger
impetus
for
using
a
similar
approach
here.

c.
Recognition
of
Uncertainty
in
Allowing
Margin
for
Safety:
The
level
of
unpredictability
in
need
leads
to
a
second
area
of
similarity
with
MDIs,
the
essential
need
for
a
review
of
the
level
of
the
request
which
takes
into
account
the
need
for
a
margin
of
safety.
With
MDIs,
it
was
essential
to
address
the
possible
change
in
patient
needs
over
time,
and
in
agriculture,
this
is
essential
to
address
the
potential
that
the
year
being
requested
for
could
be
a
particularly
bad
year
in
terms
of
weather
and
pest
pressure.
In
that
regard,
the
TEAP's
Chart
below
(
Chart
2)
demonstrates
the
manner
in
which
this
need
for
a
margin
of
safety
was
addressed
in
the
MDI
area.
Specifically,
Chart
2
tracks
national
CFC
requests
for
MDIs
compared
with
actual
use
of
CFC
for
MDIs
over
a
number
of
years.

CHART
2
Trends
in
CFC
Consumption
for
Essential
Uses
0
2000
4000
6000
8000
10000
12000
14000
16000
1996
1997
1998
1999
2000
2001
2002
2003
2004
Year
metric
tonnes
Nominated
Used
Data
for
2001
and
2004
does
not
include
quantities
for
the
Russian
Federation
and/
orUkraine
13
Chart
2
above
demonstrates
several
things.
First,
despite
the
best
efforts
of
many
countries
to
predict
future
conditions,
it
shows
that
due
to
the
acknowledged
uncertainty
of
out­
year
need
for
MDIs,
Parties
had
a
tendency
to
request,
the
TEAP
recommended,
and
the
Parties
approved
national
requests
that
turned
out
to
include
an
appreciable
margin
of
safety.
In
fact,
this
margin
of
safety
was
higher
at
the
beginning
 
about
40%
above
usage
 
and
then
went
down
to
30%
after
4
years.
Only
after
5
years
of
experience
did
the
request
come
down
to
about
10%
above
usage.
While
our
experience
with
the
Essential
Use
process
has
aided
the
U.
S.
in
developing
its
critical
use
nomination,
we
ask
the
MBTOC,
the
TEAP
and
the
Parties
to
recognize
that
the
complexities
of
agriculture
make
it
difficult
to
match
our
request
exactly
with
expected
usage
when
the
nomination
is
made
two
to
three
years
in
advance
of
the
time
of
actual
use.

Chart
2
also
demonstrates
that,
even
though
MDI
requests
included
a
significant
margin
of
safety,
the
nominations
were
approved
and
the
countries
receiving
the
exemption
for
MDIs
did
not
produce
the
full
amount
authorized
when
there
was
not
a
patient
need.
As
a
result,
there
was
little
or
no
environmental
consequence
of
approving
requests
that
included
a
margin
of
safety,
and
the
practice
can
be
seen
as
being
normalized
over
time.
In
light
of
the
similar
significant
uncertainty
surrounding
agriculture
and
the
out
year
production
of
crops
which
use
methyl
bromide,
we
wish
to
urge
the
MBTOC
and
TEAP
to
take
a
similar,
understanding
approach
for
methyl
bromide
and
uses
found
to
otherwise
meet
the
critical
use
criteria.
We
believe
that
this
too
would
have
no
environmental
consequence,
and
would
be
consistent
with
the
Parties
aim
to
phaseout
methyl
bromide
while
ensuring
that
agriculture
itself
is
not
phased
out.

d.
Duration
of
Nomination:
It
is
important
to
note
that
the
nomination
includes
a
request
for
a
critical
use
exemption
for
2005,
and
2006.
This
multi­
year
request
is
consistent
with
the
TEAP
recognition
that
the
calendar
year
does
not,
in
most
cases,
correspond
with
the
cropping
year.
This
request
takes
into
account
the
facts
that
registration
and
acceptance
of
new
efficacious
alternatives
can
take
a
long
time,
and
that
alternatives
must
be
tested
in
multiple
cropping
cycles
in
different
geographic
locations
to
determine
efficacy
and
consistency
before
they
can
be
considered
to
be
widely
available
for
use.
Finally,
the
request
for
multiple
years
is
consistent
with
the
expectation
of
the
Parties
and
the
TEAP
as
evidenced
in
the
Parties
and
MBTOC
request
for
information
on
the
duration
of
the
requested
exemption.
As
noted
in
paragraphs
5
and
9b
above,
we
are
requesting
that
the
exemption
be
granted
in
a
lump
sum
of
9,920,965
kilograms
for
2005
and
9,445,360
kilograms
for
2006.
While
it
is
our
hope
that
the
registration
and
demonstration
of
new,
cost
effective
alternatives
will
result
in
even
speedier
reductions
on
later
years,
the
decrease
in
our
request
for
2006
is
a
demonstration
of
our
commitment
to
work
toward
further
reductions
in
our
consumption
of
methyl
bromide
for
critical
uses.
In
that
regard,
methyl
bromide
is
scheduled
for
a
reregistration
decision
in
2005;
typically
re­
registration
actions
result
in
additional
restrictions
being
placed
on
the
use
of
a
product.
At
this
time,
however,
we
have
not
believed
it
possible
to
provide
a
realistic
assessment
of
exactly
which
uses
would
be
reduced
to
account
for
the
overall
decrease
in
2006.

e.
Environmental
Perspective:
Finally,
we
wish
to
put
our
request
for
a
methyl
bromide
critical
use
exemption
in
historic
and
environmental
perspective.
In
1996,
the
United
States
requested
4390
ODP­
tonnes
for
an
exemption
for
CFCs.
Using
the
latest
TEAP
best
estimate
of
the
ODP
for
methyl
bromide
(.
38),
the
U.
S.
request
for
an
initial
methyl
bromide
critical
use
exemption
is
3783
ODP
tonnes,
which
is
14%
below
our
original
CFC
MDI
request,
and
it
represents
less
than
1%
of
our
14
historic
baseline
consumption
of
all
ozone
depleting
substances.
As
demonstrated
by
the
research
components
of
and
downward
trend
in
our
request,
the
U.
S.
is
fully
committed
to
finding
and
implementing
alternatives
to
methyl
bromide,
and
proceeding
to
phaseout
its
use
once
technically
and
economically
viable
alternatives
are
available
to
meet
the
needs
of
U.
S.
users.

10.
Contact
Information
In
order
to
ensure
the
most
prompt
response
to
any
inquiries
regarding
the
U.
S.
nomination,
we
would
like
inquiries
to
be
directed
to
John
Thompson
at
the
U.
S.
Department
of
State.
We
will
strive
to
ensure
the
most
prompt
response
possible
to
any
inquiries
that
may
be
forthcoming.

John
E.
Thompson,
Ph.
D.
Office
of
Environmental
Policy
U.
S.
Department
of
State
2201
C
Street
NW,
Room
4325
Washington,
DC
20520
tel:
202­
647­
9799
fax:
202­
647­
5947
e­
mail:
ThompsonJE2@
state.
gov
Alternate
Contact:
Denise
Keehner,
Director
Biological
and
Economic
Analysis
Division
Office
of
Pesticides
Programs
U.
S.
Environmental
Protection
Agency
(
7503C)
1200
Pennsylvania
Ave.,
NW
Washington,
DC
20460
tel:
703­
308­
8200
fax:
703­
308­
8090
e­
mail:
methyl.
bromide@
epa.
gov