Document ID: EPA-HQ-OPP-2005-0123-0237
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-08-09T04:00Z

UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
MEMORANDUM
Date:
August
2,
2006
Subject:
Agency
Responses
to
Phase
5
Public
Comments
Related
to
Methyl
Bromide's
Commodity
Risk
Assessments
and
Risk
Mitigation
Options
Proposal
From:
Steven
Weiss,
Chemical
Review
Manager
Special
Review
Branch,
Special
Review
and
Reregistration
Division
To:
Methyl
Bromide
Docket
(
EPA­
HQ­
OPP­
2005­
0123)

The
Environmental
Protection
Agency
(
EPA)
is
developing
a
decision
regarding
the
Food
Quality
Protection
Act
(
FQPA)
tolerance
reassessment
for
methyl
bromide
and
reregistration
eligibility
of
the
commodity
uses
of
the
active
ingredient
methyl
bromide
through
a
6­
phase
public
participation
process.
During
the
public
comment
period
of
Phase
5,
which
closed
on
May
29,
2006,
the
Agency
solicited
comments
on
its
risk
assessments
and
risk
mitigation
options
proposal.
The
Agency
received
comments
from
18
sources:
California
Department
of
Pesticide
Regulation;
Value
Recovery,
Inc;
Dow
AgroSciences,
LLC;
The
Royal
Group;
USA
Rice
Federation;
Western
Industries­
North,
Inc;
ASOEX;
Natural
Resources
Defense
Council;
Fumigation
Service
&
Supply,
Inc.;
Pet
Food
Institute;
North
American
Millers'
Association
(
NAMA);
Methyl
Bromide
Industry
Panel
(
MBIP);
National
Pest
Management
Association
(
NPMA);
Industrial
Fumigant
Company
(
IFC);
US
Department
of
Agriculture/
Animal
and
Plant
Health
Inspection
Service
(
USDA/
APHIS);
and
a
citizen.
Most
of
the
comments
received
were
related
to
feasibility,
cost,
and
impact
of
risk
mitigation
options
document.
The
attached
table
contains
the
Agency's
response
to
the
Phase
5
public
comments.
2
#
ID
Public
Comment
Agency
Response
1
USA
Rice
In
addition
to
other
mitigation
efforts,
the
agency
is
considering
trying
to
apply
the
existing
California
regulatory
regime
for
MeBr
fumigations
to
the
rest
of
the
country
through
this
Reregistration
Eligibility
Decision
framework.
Among
the
many
possible
problems
with
this
approach,
one
stands
out.
The
California
system
relies
on
the
County
Agricultural
Commissioners
to
provide
oversight,
permitting
and
enforcement
during
structural
fumigations.
However
this
bureaucratic
system
is
not
duplicated
in
the
other
rice
states.
This
fact
presents
an
enormous
flaw
in
the
basic
underpinnings
of
any
California
system,
as
it
would
be
applied
to
other
states.
The
Agency
agrees.
Agency's
RED
requires
the
responsible
party
(
i.
e.
the
person
supervising
the
fumigation)
must
certify
in
writing
that
he/
she
has
reviewed
the
FMP
and
that
it
addresses
all
elements
required
by
product
labels
and
the
Agency
methyl
bromide
commodity
fumigation
reference
manual,
and
that
all
decisions
on
the
treatment/
aeration
processes,
buffer
zones,
and
PPE
are
appropriate
and
protective.
States
or
local
governments
may
opt
to
require
third­
party
certification
(
e.
g.,
county
agricultural
commissioners,
state
pesticide
enforcement
officials,
certified
industrial
hygienists,
or
certified
safety
professionals).
In
that
case,
where
fumigations
are
supervised
by
a
federal
authority
such
as
APHIS,
the
federal
agency
may
certify
the
FMP.
The
responsible
party
must
contact
the
applicable
State
lead
agency
to
determine
the
certification
requirements
for
that
state.
2
USA
Rice
California
DPR
requires
very
low
concentrations
in
order
to
achieve
a
100­
fold
safety
margin
for
the
areas
surrounding
a
fumigation.
During
fumigations
the
structures
and
facilities
are
evacuated
except
for
those
necessary
to
the
procedure.
Air
monitoring
is
maintained.
USA
Rice
believes
this
should
be
sufficient
for
protection.
DPR
has
estimated
that
a
100­
fold
margin
of
safety
is
achieved
if
air
concentrations
do
not
exceed
0.21
ppm
measured
as
a
24­
hour
time
weighted
average.
This
exposure
is
equivalent
to
0.63
ppm
as
an
8­
hour
time
weighted
average
or
20
ppm
as
a
15­
minute
time
weighted
average.
DPR's
permit
conditions
apply
only
to
California.

Current
EPA
labels
are
based
on
a
5
ppm
exposure
limit
(
measured
with
direct
read
methods.
EPA
risk
assessment
is
based
on
an
UF
of
30
and
an
8­
hour
HEC
of
30
ppm
(
concentrations
greater
than
1
ppm
are
a
risk
concern).
3
NAMA
We
oppose
the
use
of
the
California
system
as
a
template
for
national
regulation.
California
has
an
entire
infrastructure
in
place
with
people
and
processes
for
regulating
pesticide
usage.
To
merely
duplicate
that
system
and
impose
it
on
other
states
where
that
infrastructure
does
not
exist
would
be
cumbersome,
unrealistic
and
would
not
add
to
the
safe
usage
of
methyl
bromide.
We
do
not
think
it
is
in
the
best
interests
of
the
public,
the
industry
or
EPA
to
put
in
place
regulations
for
which
the
infrastructure,
including
a
compliance
and
enforcement
program,
do
not
exist.
Also,
the
California
system
was
developed
to
address
the
pre­
existing
use
patterns
and
exposure
issues
unique
to
soil
fumigation
in
that
state.
Those
use
patterns
and
exposure
issues
are
not
applicable
to
regulating
structural
fumigations
such
as
grain
mills.
The
Agency
agrees
that
than
California
system
can
not
be
used
as
a
drop
in
approach
for
the
US.
However,
the
Agency
does
believe
that
mitigation
options
for
EPA
labels
can
be
developed
based
on
many
of
the
elements
that
are
currently
required
by
CDPR.
Furthermore,
CDPR
does
require
permits
for
non­
soil
fumigation
including
structural
fumigations
such
as
grain
mills.

4
MBIP
The
MBIP
takes
issue
with
EPA's
assertion
that
California's
approach
for
managing
risks
from
post­
harvest
fumigation
is
"
effective
and
feasible."
California
has
developed
a
sophisticated
system
of
regulations
to
manage
risks
from
fumigation
on
a
site­
by­
site
basis.
This
system
is
complicated
and
expensive.
It
is
unique
to
California
because
it
relies
on
a
regulatory
infrastructure
of
local/
county
agricultural
commissioners
who
can
apply
controls
to
site­
specific
conditions
through
a
permitting
system.
EPA
provides
no
evidence
to
support
the
claim
of
that
this
system
is
effective
or
that
it
would
be
feasible
to
implement
it
on
a
nation
wide
basis.
The
vast
majority
of
post­
harvest/
food
processing
plant
fumigations
do
not
occur
in
California.
Thus,
the
California
system
does
not
necessarily
provide
a
model
for
a
system
that
would
be
feasible
for
all
areas.
See
response
#
3.

5
Royal
Although
it
is
not
mentioned
as
a
risk
mitigation
proposal,
Royal
has
heard
in
the
industry
of
proposals
by
EPA
to
lower
the
5
ppm
requirement.
Royal
is
not
aware
of
data
that
support
the
need
for
any
lower
exposure
requirement
and
believes
such
data
should
be
made
known.
In
addition,
current
technology
permits
us
to
measure
for
the
5
ppm
level
but
not
any
level
significantly
lower
than
that.
We
have
explored
instrumentation
and
believe
that
the
cost
of
equipment
to
measure
lower
The
Agency
appreciates
the
information
provided
by
this
commenter
and
has
considered
this
information,
along
with
other
pertinent
data,
in
its
alternatives
and
user
impact
analysis
for
the
proposed
risk
mitigations.
3
#
ID
Public
Comment
Agency
Response
levels
of
methyl
bromide
would
probably
be
in
the
range
of
$
15,000
to
$
20,000
per
unit,
as
compared
to
the
colorimetric
tubes
in
use
now
(
costing
less
than
$
10
each)
and
even
the
most
expensive
infrared
units
(
such
as
the
"
MiniRae,"
which
costs
several
thousand
dollars).
On
a
busy
fumigation
night,
Royal
can
use
more
than
10
monitoring
devices,
plus
infrared
"
spot"
readers
and
countless
colorimetric
tubes.
The
cost
associated
with
a
change
in
the
permissible
levels
of
methyl
bromide,
then,
is
substantial.
Finally,
although
Royal
understands
the
desire
to
make
methyl
bromide
use
safer,
a
desire
Royal
certainly
shares,
the
proposals
appear
to
take
the
approach
that
the
most
logical
way
to
attain
the
goal
of
safety
is
to
set
specific
limits
that
would
apply
to
all
fumigations.
In
its
two
decades
of
fumigation
Royal
has
learned
that
no
two
fumigations
are
alike
because
there
are
so
many
complex
factors
that
can
affect
the
fumigation.
Royal's
goal
has
always
been
control,
not
the
application
of
absolute
limits.
For
control,
we
need
the
years
of
experience
of
our
fumigators,
the
input
of
the
experience
of
APHIS,
inquiring
minds
that
examine
and
re­
examine
our
data,
a
full
knowledge
of
many
different
types
of
equipment
and
the
ability
to
design
new
equipment,
a
flexible
infrastructure
and
flexibility
in
our
operations
and
responses
to
conditions.
We
believe
that
the
best
course
to
a
safer
and
more
efficient
use
of
methyl
bromide
consists
of
utilizing
the
knowledge
in
the
industry
and
in
APHIS,
and
rewarding
companies
that
achieve
demonstrable
control.
6
APHIS
Allowable
Air
Concentration:
APHIS
requests
that
EPA
consider
permitting
the
allowable
ambient
air
concentration
of
methyl
bromide
to
remain
at
5
ppm,
or
1/
6
of
the
EPA's
acceptable
Human
Equivalent
Concentration
(
HEC)
of
30
ppm
methyl
bromide.
EPA's
suggested
uncertainty
factor
of
30
has
diminished
the
allowable
air
concentration
to
1
ppm;
this
amount
is
below
the
level
of
detection
of
any
portable
air
concentration
detection
devices
currently
available
on
the
market.
Although
APHIS
has
identified
a
company
which
is
interested
in
developing
such
technology,
there
is
no
guarantee
as
to
when
an
adequate
device
might
enter
the
market,
or
whether
it
would
be
as
accurate
as
the
company
claims
it
will
be.
Today's
portable
detectors
determine
air
concentrations
down
to
1
ppm
with
an
accuracy
of
±
1
ppm.
This
would
indicate
that
2
ppm
(
1/
15
of
EPA's
HEC)
would
be
the
lowest
air
concentration
that
could
be
adequately
measured.
However,
APHIS
has
been
supervising
fumigations
for
over
20
years
using
the
current
5
ppm
safety
level
with
no
record
of
detrimental
human
health
effects.
Since
the
current
standard
is
already
six
times
lower
than
the
acceptable
HEC,
a
reconsideration
of
the
allowable
air
concentration
is
requested.
The
Agency
is
aware
of
the
screening
level
issue
related
to
real­
time
monitoring
devices.
It
is
also
investigating
the
feasibility
of
alternative
sampling
methods
(
e.
g.,
sampling
pump
with
resin
cartridges
or
vacuum
canister)
related
to
the
types
of
monitoring
protocols
employed
by
APHIS.

It
should
be
noted
that
1
ppm
8­
hour
TWA
pertains
to
air
concentration
that
is
of
concern
for
human
exposure
and
not
the
concentration
that
commodities
must
be
aerated
to.

7
APHIS
A
consequence
of
lowering
the
acceptable
air
concentration
may
be
detrimental
economic
effects
on
a
local,
national,
and
global
scale.
It
will
take
significantly
longer,
in
some
cases
up
to
one
day,
to
remove
methyl
bromide
down
to
a
lower
level
during
the
aeration
process.
Any
increase
aeration
time
will
slow
the
flow
of
commerce
at
the
ports.
Vessels
and
cargo
may
back
up,
both
at
our
country
and
at
the
exporting
country;
perishable
commodities
may
become
unmarketable
due
to
spoilage,
as
they
await
fumigation
without
proper
storage
conditions.
The
income
stream
to
the
Port
Authorities
(
i.
e.,
the
States)
may
be
reduced
as
fumigation
business
on
their
property
slows.
A
long­
term
effect
may
be
a
reduction
in
imports
which
will
cause
foreign
governments
to
take
more
restrictive
actions
on
our
nation's
exported
products.
The
Agency
acknowledges
that
the
specific
risk
mitigation
options
that
are
being
considered
would
likely
have
a
different
economic
effect
on
each
facility
that
conducts
fumigations.
Further,
the
Agency
agrees
that,
depending
on
the
particular
risk
mitigation
option
selected
and
the
site­
specific
conditions
of
the
facility,
some
options
could
produce
substantial
adverse
economic
effects.

8
Private
Citizen
The
use
of
this
toxic
chemical
should
not
be
allowed
at
all
in
any
place.
The
Agency's
has
determined
that
MeBr
can
be
used
safely
provided
mitigation
measures
specified
in
the
RED/
TRED
are
followed.
9
NRDC
Mitigation
methods
(
other
than
use
of
alternatives)
cannot
effectively
and
adequately
protect
workers,
nearby
residents,
or
the
broader
U.
S.
and
global
population
at
risk
due
to
these
uses
of
MBr
See
response
#
8.

10
NRDC
Recognizing
the
unsafe
uses
of
MBr
and
the
impracticalities
of
achieving
comprehensive
exposure
mitigation,
coupled
with
the
mandated
phase­
out
of
this
product,
all
uses
of
MBr
should
be
considered
ineligible
for
FIFRA
reregistration
and
FQPA
tolerance
reassessment.
The
Agency
believes
that
many
uses
can
be
re
registered
in
compliance
with
FIFRA
and
FQPA.
See
response
#
8,
regarding
risk
mitigation.
It
should
also
be
noted
that
pre­
shipment
and
quarantine
uses
are
exempt
from
phase
out
under
the
Montreal
Protocol.
11
CDPR
To
be
considered
safe
for
use
in
the
State
of
California
methyl
bromide
uses
in
structures
and
on
food
commodities
within
chambers
requires
a
series
of
regulations
and
specific
requirements
to
be
followed.
Questions
and
Answers
These
product
use
rules
for
methyl
bromide
in
California
are
intended
to
protect
both
bystander
and
worker
exposures,
both
of
which
have
been
determined
to
be
This
information
provided
was
used
by
the
Agency
to
develop
a
risk
reduction
mitigation
strategy
for
MeBr's
commodity
uses.
4
#
ID
Public
Comment
Agency
Response
excessive
by
the
USEPA
in
their
risk
assessment.
These
requirements
(
attached
to
these
comments),
created
by
CDFA
and
California
Department
of
Pesticide
Registration
have
been
determined
to
lead
to
safe
use
conditions.
These
use
conditions,
appropriate
for
California
have
been
determined
to
be
effective
and
would
be
appropriate
for
implementation
in
the
rest
of
the
United
States.
(
several
files
were
sent
with
comment
that
contain
CDPR
requirements
and
guidelines)
12
NRDC
Methyl
bromide
is
a
broad
spectrum
pesticide
and
extremely
toxic
vapor.
In
humans,
is
readily
absorbed
through
the
lungs,
resulting
in
human
poisoning
incidents
following
inhalation
exposure.
This
is
of
particular
risk
given
that
the
toxicity
effects
occur
at
a
much
lower
level
than
the
odor
threshold,
so
people
may
not
even
know
that
they
are
being
exposed.
Further
effects
can
be
delayed
for
days
or
even
months
after
exposure,
since
it
is
a
cumulative
poison.
Effects
range
from
headaches
and
nausea
to
death
in
extreme
cases.
Inhalation
of
1,600
ppm
for
10­
20
hours,
or
7,900
ppm
for
1.5
hours
is
lethal
to
humans.
The
lowest
inhalation
level
found
to
cause
toxicity
in
humans
is
35
ppm
in
air.
The
Agency
notes
that
all
HECs
used
for
risk
assessment
purposes
are
<
35
ppm
cited
by
NRDC.
For
acute
risk
assessments
the
HECs
used
are
10
and
30
ppm
for
bystander
(
non­
occupational)
and
occupational
exposures,
respectively.
HECs
for
all
other
inhalation
exposure
scenarios
are
 
4.4
ppm,
well
below
the
concentration
cited
by
NRDC.
13
NRDC
MBr
is
also
a
direct
threat
to
the
health
of
people
who
work
with
it.
The
National
Cancer
Institute
has
linked
methyl
bromide
to
increased
prostate
cancer
risks
in
a
study
of
55,000
pesticide
applicators,
including
farmers,
nursery
workers,
and
workers
in
warehouses
and
grain
mills.
Inexplicably,
EPA
nonetheless
continues
to
classify
MBr
as
not
likely
to
be
carcinogenic
to
humans
(
OPP­
2005­
0123­
0135,
p.
21).
As
part
of
the
Agricultural
Health
Study,
additional
analyses
­
including
evaluation
of
a
larger
sample
size
­
are
being
conducted
to
further
elucidate
the
apparent
link
between
methyl
bromide
exposure
and
prostate
cancer.
At
the
conclusion
of
these
evaluations,
the
Agency
will
consider
the
results
in
conjunction
with
the
previous
study
results
as
appropriate.
14
MBIP
Uncertainty
Factor
Removed
For
Lack
of
DNT
Study
­­
Page
14
The
MBIP
supports
EPA's
decision
to
remove
the
10x
uncertainty
factor
previously
applied
for
lack
of
a
DNT
study.
The
additional
uncertainty
factor
was
applied
in
previous
iterations
on
the
risk
assessment.
The
MBIP
submitted
a
DNT
study,
which
the
Agency
has
reviewed
and
found
acceptable.
This
study
eliminates
the
need
for
the
uncertainty
factor,
and
thus,
in
accordance
with
current
HED
policy,
the
Agency
has
properly
removed
it
from
the
Post­
Harvest
RA.
No
response
needed.

15
MBIP
Endpoints
for
Short­
and
Intermediate­
Term
Inhalation
Exposures
­­
Pages
11
and
15
EPA
continues
to
use
a
sub­
chronic
inhalation
study
in
dogs
 
MRID
45722801
(
Schaefer
Study)
 
to
derive
the
endpoint
for
the
short­
and
intermediate­
term
inhalation
exposures.
As
noted
in
the
MBIP's
prior
comments,
the
Schaefer
Study
establishes
a
NOAEL
of
20
ppm.
The
Agency
continues
to
utilize
a
different
NOAEL
 
5.3
ppm
for
male
dogs
and
10
ppm
for
female
dogs.
Based
on
this
study,
the
HEC
equals
4.4
ppm
for
occupational
and
commodity
bystander
exposure.
The
MBIP
incorporates
its
previous
comments
and
submissions
on
this
issue
and
reiterates
its
request
that
EPA
reconsider
its
position
on
the
NOAEL
for
this
study.
The
Agency
has
evaluated
two
subchronic
inhalation
studies
in
dogs
and
has
conducted
a
weight­
of­
evidence
evaluation
in
establishing
the
point
of
departure
for
this
risk
assessment.
While
in
MRID
43386802
unresponsiveness
and/
or
depressed
appearance
was
reported
for
2/
8
females
exposed
to
5.3
ppm
after
32
days
of
exposure,
the
Agency
has
concluded
that
these
observations
are
spurious
given
that
no
effects
were
observed
after
5
weeks
of
exposure
at
11
ppm.
Moreover,
in
a
non­
guideline
inhalation
toxicity
study
in
dogs
(
MRID
45722801)
no
effects
were
seen
at
the
5.3
ppm
exposure
concentration
after
6
weeks
of
exposure.
Thus,
the
Agency
reaffirms
its
conclusions
that
the
NOAEL
for
these
studies
should
be
established
at
5
ppm
16
MBIP
Classification
of
Carcinogenic
Potential
 
Page
13
EPA
correctly
states
that
methyl
bromide
is
classified
as
a
"
not
likely
human
carcinogen."
However,
the
Post­
Harvest
RA
references
the
initial
results
of
an
Agricultural
Health
Study
(
AHS).
This
is
an
epidemiology
study
conducted
on
workers
exposed
to
a
wide
range
of
pesticides.
The
authors
suggested
a
link
between
prostate
cancer
and
methyl
bromide
use
in
agriculture.
However,
since
its
publication,
this
study
has
been
evaluated
by
a
blue­
ribbon
panel
of
epidemiologists
who
concluded
that
the
study
is
fundamentally
flawed.
The
chief
flaw
of
the
study
was
that
it
did
not
adjust
for
potential
confounders
other
than
age.
Among
other
findings,
the
blue­
ribbon
panel
concluded
that
despite
sporadic
positive
results,
the
study
did
not
show
consistently
increased
risks
to
support
a
causal
association
between
agricultural
pesticide
use
and
prostate
cancer.
The
panel
further
concluded
that
it
was
not
possible
to
attribute
any
particular
pesticide
as
a
putative
cause
of
prostate
cancer.
The
results
of
the
panel's
review
are
scheduled
for
publication
in
the
near
term.
In
addition,
animal
studies
submitted
and
reviewed
by
EPA
as
part
of
the
reregistration
of
methyl
bromide
do
not
show
any
evidence
of
carcinogenicity.
In
light
of
these
data,
and
the
questions
of
validity
raised
about
the
AHS,
EPA
should
See
response
#
13.
5
#
ID
Public
Comment
Agency
Response
not
use
that
study
as
a
basis
for
regulating
methyl
bromide
as
a
carcinogen.
17
NRDC
Reregistration
should
not
even
be
considered
for
uses
not
permitted
under
the
Montreal
Protocol
and
the
Clean
Air
Act;
The
Montreal
Protocol,
as
well
as
EPA
regulations
implementing
the
Clean
Air
Act,
provide
specific
exemptions
for
critical
uses
and
quarantine
and
preshipment
uses.
Additionally,
use
of
pre­
phaseout
(
pre­
2005)
inventory
is
not
restricted
under
the
Protocol,
Clean
Air
Act,
or
EPA
regulations.
The
Agency
believes
that
all
uses
considered
herein
are
authorized
by,
or
exempted
from,
the
Montreal
Protocol
and
the
Clean
Air
Act.
18
NRDC
MBr
is
now
banned
except
for
uses
that
qualify
under
the
Montreal
Protocol
and
the
Clean
Air
Act
as
either
"
quarantine
and
preshipment
uses"
or
"
critical
uses."
As
a
first
principle,
EPA's
pesticide
program
should
not
even
consider
the
reregistration
of
MBr
for
uses
that
are
not
authorized
under
the
Montreal
Protocol
and
the
Clean
Air
Act.
Thus,
for
the
purposes
of
this
proceeding,
all
uses
other
than
the
following
should
be
ruled
out
from
the
outset:
(
1)
Dry
cure
pork
products;
(
2)
California
beans,
California
dried
plums,
California
walnuts,
California
dates;
(
3)
rice
mills,
bakeries,
pet
food
facilities,
grain
mills;
and
(
4)
processed
foods,
spices/
herbs,
cocoa,
cheese
processing
plants.
Except
for
other
MBr
uses
conforming
to
QPS
requirements,
no
other
uses
of
MBr
in
the
"
enclosures,
chambers
and
structural
food
processing
facilities"
use
pattern
should
be
considered
eligible
for
FIFRA
reregistration
or
tolerance
reassessment
under
FQPA.
See
response
#
17
19
ASOEX
ASOEX
also
brings
a
unique
perspective
to
the
methyl
bromide
issue.
The
most
dramatic
evidence
of
ozone
depletion
occurs
over
the
Southern
polar
ice
cap,
which
includes
Chilean
territory.
For
this
reason,
ASOEX
aggressively
explored
means
to
reduce
methyl
bromide
emissions
in
its
operations
in
Chile
and,
to
the
extent
practicable,
to
comply
with
fumigation
requirements
by
use
of
facilities
in
the
U.
S.
ports
of
entry.
If
the
commodity
use
of
methyl
bromide
is
further
limited
in
the
U.
S.,
all
Chilean
fresh
produce
exports
would
necessarily
be
fumigated
in
Chile
prior
to
export,
with
the
possibility
that
ozone­
depleting
emissions
would
occur
at
points
much
closer
to
the
existing
ozone
hole.
ASOEX
doubts
that
the
U.
S.
Congress,
EPA
or
the
USDA
intended
any
law,
its
amendments
and
implementing
regulations
to
increase
the
risk
of
ozone
depletion.
EPA
agrees
that
there
are
minor
latitudinal
differences
in
impact
according
to
the
location
of
ODS
emissions.
The
commenter
has
provided
no
specific
information
regarding
changes
in
fumigation
practices
for
quarantine
commodities
potentially
affected
by
a
U.
S.
phasedown
in
MeBr
use.

20
NRDC
In
addition
to
its
hazard
to
human
health,
MBr
is
the
most
powerful
ozonedepleting
chemical
still
in
widespread
use.
After
more
than
a
decade's
lead
time,
the
deadline
for
phasing
out
MBr
fell
on
December
31,
2004,
with
exceptions
allowed
only
for
"
critical
uses"
and
for
"
quarantine
and
pre­
shipment
uses."
One
condition
for
a
critical
use
exemption
is
the
absence
of
technologically
and
economically
feasible
alternatives.
The
MBr
exemptions
allowed
in
2005
and
2006
are
estimated
to
cause
more
than
20
deaths
from
skin
cancer,
more
than
4,000
other
skin
cancers
cases,
and
more
than
1,400
cataract
cases,
in
the
U.
S.
alone.
The
global
health
toll
will
be
much
larger.
Although
EPA
has
not
specifically
calculated
the
number
of
deaths
that
will
arise
as
a
result
of
both
the
2005
and
2006
critical
use
exemptions,
EPA
experts
concur
that
the
commenter's
estimate
falls
within
the
range
projected
by
the
Agency's
AHEF
model.

21
NRDC
This
exposure
risk
mitigation
proposal,
however,
will
not
reduce
the
overall
MBr
usage,
and
thus
the
hazard
to
the
ozone
layer,
in
any
significant
way.
Does
EPA
have
data
supporting
its
estimated
impact?
If
so,
what
is
the
source
of
this
data,
and
what
are
the
costs
associated
with
this
proposal
compared
with
the
estimated
impact
on
MBr
total
usage?
Has
EPA
evaluated
the
impact
of
this
restriction
on
the
attractiveness
of
alternative
pest
control
methods?
The
majority
of
options
focus
is
on
reducing
direct
exposure
to
MeBr.
However,
several
of
the
options
could
be
effective
in
reducing
the
overall
amount
of
MeBr
emitted
and
destruction
of
the
ozone
layer.
These
include:
recovery
destruction
systems,
alternatives,
lower
rates,
and
integrated
pest
management.
These
options
used
in
combination
with
other
options
(
e.
g.
enclosure
performance
criteria)
could
also
be
effective
in
reducing
MeBr
emitted.
The
Agency
has
also
included
a
qualitative
impact
of
mitigation
measures
that
is
included
in
the
docket.
22
MBIP
EPA
refers
to
the
Office
of
Atmospheric
Program's
(
OAP's)
estimate
of
the
number
of
UV­
related
skin
cancer
incidents
based
on
commodity
uses
of
methyl
bromide.
There
are
significant
problems
with
the
Atmospheric
and
Health
Effects
(
AHEF)
model
used
in
the
OAP
analysis,
leading
to
an
overestimate
of
the
risk.
Even
if
these
problems
were
not
present,
the
issue
of
increased
UV
exposure
is
not
pertinent
to
the
Office
of
Pesticide
Program's
current
risk
assessment
of
methyl
bromide
for
reregistration
purposes.
The
docket
document
referenced
here
­
"
The
Role
of
Methyl
Bromide
in
Stratospheric
Ozone
Depletion:
Science
and
Health
Considerations"
 
includes
a
detailed
description
of
the
peer
review
process
the
AHEF
model
has
undergone.
The
AHEF
model
has
been
extensively
peer­
reviewed,
most
recently
in
1999,
2001,
and
2003,
and
has
been
used
to
6
#
ID
Public
Comment
Agency
Response
support
EPA's
regulatory
impact
analysis
for
the
critical
use
program
as
well
as
the
2001
Report
to
Congress
on
the
Benefits
and
Costs
of
the
Clean
Air
Act.
The
Agency
considers
methyl
bromide's
health
effects
due
to
stratospheric
ozone
depletion
appropriate
for
consideration
in
overall
health
effects
assessment
undertaken
in
the
reregistration
process
23
CDPR
All
of
the
mitigation
options
discussed
are
consistent
or
compatible
with
the
current
regulatory
requirements
in
California.
Complying
with
buffer
zone
requirements
is
the
most
difficult
for
most
facilities.
Impacts
primarily
depend
on
location
of
the
facility
within
a
community
as
well
as
the
specific
location
of
the
chambers
or
other
fumigation
enclosures
within
the
facility.
Impacts
are
greatest
where
the
facility
or
enclosure
is
situated
near
where
people
work
or
live.
Food
processing
plants
that
use
several
hundred
or
several
thousand
pounds
of
methyl
bromide
to
fumigate
an
entire
facility
are
a
particular
concern.
Some
mitigation
options
have
greater
impact
on
certain
types
of
facilities.
For
example,
some
fresh
fruit
facilities
have
problems
complying
with
minimum
aeration
requirements.
The
Agency
appreciates
the
information
provided
by
this
commenter
and
has
considered
this
information,
along
with
other
pertinent
data,
in
its
analysis
of
the
proposed
risk
mitigations.

24
CDPR
While
aeration
though
an
elevated
stack
mitigates
exposure
in
most
situations,
in
a
few
cases
exposure
can
be
increased.
Stacks
rely
on
vertical
distance
to
dilute
ground­
level
concentrations.
Facilities
where
the
top
of
the
stack
is
at
the
same
level
as
windows,
doors,
or
air
intakes
of
nearby
buildings
can
be
problematic.
The
mitigation
options
should
address
this
situation.
See
response
#
23
25
CDPR
Unless
included
in
the
occupational
mitigation
options,
U.
S.
EPA
should
consider
controlling
exposure
from
fumigated
commodities
in
enclosed
storage
and
processing
areas.
Some
fumigated
commodities
continue
to
off­
gas
methyl
bromide
after
aeration
is
completed.
The
off­
gassing
can
lead
to
increasing
concentrations
in
enclosed
storage
and
processing
areas,
possibly
causing
unacceptable
exposure
to
people
working
in
these
areas.
In
California,
this
issue
is
a
concern
for
some
nut
facilities.
See
response
#
23
26
CDPR
Fumigation
chambers
that
share
common
walls
with
another
structure
are
also
a
concern.
Few
chambers
are
gas­
tight
and
some
leakage
occurs
into
the
adjoining
structure.
Mitigating
the
exposure
to
people
working
in
the
adjoining
structure
is
difficult
unless
the
adjoining
structure
is
vacated
during
fumigation.
See
response
#
23
27
CDPR
While
implementation
was
difficult,
the
majority
of
California's
facilities
adapted
to
CDPR's
requirements,
and
are
still
fumigating
with
methyl
bromide.
See
response
#
23
28
MBIP
Implementing
the
requirements
of
the
California
permitting/
buffer
zone
system
on
a
nationwide
basis
also
raises
issues
regarding
"
unfunded
federal
mandates"
under
the
Unfunded
Mandates
Reform
Act
of
1995,
P.
L.
104­
4,
2
U.
S.
C.
§
1501,
et
seq.
("
the
Act").
This
Act
was
enacted
"
to
end
the
imposition,
in
the
absence
of
full
consideration
by
Congress
of
Federal
mandates
on
state,
local
and
tribal
governments
without
adequate
funding
.
.
.
"
See
Section
2
of
the
Act,
2
U.
S.
C.
§
1501.
Moreover,
imposing
the
California
model
on
other
states
may
affect
an
unconstitutional
commandeering
of
governmental
processes
into
federal
service.
See
e.
g.,
New
York
v.
United
States,
505
U.
S.
144,
174­
177
(
1992)
(
Federal
government
may
not
simply
`
commandeer
the
processes
of
the
States
by
directly
compelling
them
to
enact
and
enforce
a
federal
regulatory
program.)
quoting
Hodel
v.
Virginia
Surface
Mining
&
Reclamation
Assn.,
Inc.,
452
U.
S.
264,
288
(
1981).
As
noted
above,
many
States
do
not
have
the
regulatory
systems
and
support
necessary
to
implement
a
system
like
California's.
If
that
system
were
imposed
as
part
of
the
Agency's
approach
for
risk
mitigation,
the
States
would
necessarily
be
compelled
to
use
their
own
funds
to
establish
regulatory
infrastructures
necessary
to
implement
those
requirements.
Such
a
result
may
constitute
an
unconstitutionally­
imposed
burden
on
the
States.
The
mitigation
measures
required
by
the
Agency
provide
states
or
other
federal
agencies
flexibility
to
decide
to
what
extent
they
would
like
to
oversee
these
requirements,
including
the
option
to
self
certify
fumigation
management
plans.

29
APHIS
While
fumigation
facilities
do
exist
in
California,
the
administrative
burden
and
costs
associated
with
complying
with
this
state's
permitting
regulations
have
resulted
in
global,
national,
and
local
economic
effects,
all
of
which
should
be
examined
by
EPA
before
a
decision
is
made
that
California's
approach
for
managing
fumigation
is
effective
and
feasible
on
a
national
scale.
Global
ramifications
include
the
choices
made
by
importer/
exporters
from
various
nations
on
the
port­
of­
entry
to
ship
their
commodities.
The
costs
associated
with
complying
with
the
permitting
regulations
have
driven
up
the
costs
of
fumigating
commodities
in
California
to
the
point
that
many
countries
who
export
commodities
requiring
mandatory
fumigation
upon
entry
into
this
country
choose
to
send
their
products
to
eastern
ports.
As
examples,
APHIS
will
address
two
major
imported
commodities
which
are
known
to
carry
actionable
plant
pests.
The
Agency
also
acknowledges
that
the
specific
risk
mitigation
options
that
are
being
considered
would
likely
have
a
different
economic
effect
on
each
facility
that
conducts
fumigations.
Further,
the
Agency
agrees
that,
depending
on
the
particular
risk
mitigation
option
selected
and
the
site­
specific
conditions
of
the
facility,
some
options
could
produce
substantial
adverse
economic
effects.
The
Agency
has
also
included
a
qualitative
impact
of
mitigation
measures
that
is
7
#
ID
Public
Comment
Agency
Response
Chilean
fruit,
particularly
grapes,
require
mandatory
fumigation
upon
entry
into
our
ports
due
to
known
presence
of
quarantine
mites.
Quarantine
pests
are
frequently
intercepted
on
imported
Italian
tile;
when
that
occurs,
the
tile
may
not
enter
the
country
without
fumigation.
Since
fumigation
costs
are
so
high
in
California,
Chilean
fruit
exporters
as
well
as
Italian
tile
exporters
both
ship
a
great
majority
of
their
products
to
eastern
ports.
The
Italian
embassy
has
complained
to
APHIS
that
the
cost
of
fumigating
Italian
tiles
in
California
is
seven
times
higher
than
it
is
for
fumigation
at
eastern
ports.
Regional
fumigation
costs
are
not
controllable
by
APHIS
regulation
and
cannot
be
addressed
by
APHIS.
Fumigation
costs
are
driven
by
the
costs
borne
by
the
local
fumigators
which
are
passed
on
to
the
users.
National
ramifications
include
effects
on
the
manner
in
which
imported
commodities
are
transported
and
distributed
throughout
the
nation.
APHIS
has
shown
that,
due
to
the
higher
costs
associated
with
fumigation
in
California,
products
requiring
mandatory
fumigation
are
more
often
shipped
to
eastern
ports,
where
it
is
cheaper
to
fumigate.
From
these
eastern
ports,
these
commodities
are
then
moved
westward
by
the
trucking
industry.
Chilean
grapes
arriving
at
the
port
of
Philadelphia
are
known
to
be
transported
to
distribution
centers
located
in
Montana,
Colorado,
Idaho,
and
even
Texas.
From
these
western
distribution
centers,
the
grapes
are
trucked
even
further
west
to
local
retailers,
sometimes
as
far
as
California,
whose
ports
might
have
received
the
imported
grapes
directly
had
it
not
been
for
the
costs
associated
with
permitting
regulations.
Local
effects
are
a
result
of
the
national
ramifications
just
described,
specifically,
in
the
amount
of
business
conducted
in
a
region,
as
it
appears
that
California
ports,
and
with
it
the
associated
economic
infrastructure,
are
loosing
business
to
eastern
ports.
Another
local
ramification
may
include
the
effect
the
California
regulations
have
had
on
local
fumigation
facilities.
A
fumigation
facility
consisting
of
five
airtight
chambers
just
off
the
pier
in
Oakland
was
unable
to
meet
the
city
of
Oakland's
air
permitting
and
zoning
regulations;
consequently,
there
has
been
a
complete
cessation
of
operations
at
this
location.
The
fumigator
subsequently
was
approved
to
operate
at
a
nearby
container
fumigation
station
but
was
able
to
move
only
a
single
240
cubic
foot
chamber
to
that
location.
The
result:
four
airtight
chambers
remain
unused
while
fumigation
continues
using
the
less
tight
direct
container
or
tarpaulin
fumigation
methods.
included
in
the
docket.

30
NRDC
EPA's
own
assessment
reports
that
worker
exposures
exceed
EPA
tolerable
levels
in
all
scenarios
associated
with
industrial
fumigation
activities
for
all
exposure
durations
if
no
respiratory
protection
is
used
(
p.
61).
Chronic
exposures
exceed
EPA's
level
of
concern
for
all
durations
regardless
of
whether
or
not
respirators
are
used
(
p.
61).
Has
EPA
determined
whether
more
air­
tight
facilities
would
not
increase
unsafe
worker
exposure
levels?
The
Agency
concurs
with
NRDC's
assessment
of
the
risks
which
have
been
calculated.
However,
it
is
not
likely
that
more
"
air­
tight"
facilities
would
substantively
increase
unsafe
worker
exposure
levels.
Commodity
applications
are
made
using
a
regimented
schedule
that
provides
for
a
target
methyl
bromide
concentration
over
a
specific
timeframe
(
i.
e.,
CxT
schedule).
As
such,
applicators
would
maintain
methyl
bromide
levels
over
scheduled
treatment
durations
at
a
specific
target
concentration.
If
facilities
were
more
air­
tight
it
would
mean
less
additional
material
would
be
added
to
maintain
the
target
concentration
but
the
target
concentration
would
be
the
same,
hence,
worker
exposure
levels
would
also
remain
constant.
31
PFI
As
more
fully
explained
below,
members
of
PFI
are
concerned
that
the
EPA's
risk
assessment
is
based
on
assumptions
regarding
use
rates
and
applications
that
do
not
reflect
actual
methyl
bromide
use
practices.
These
errors
appear
to
have
distorted
the
Agency's
assessment.
Given
the
importance
of
methyl
bromide
as
a
tool
to
eliminate
pests
from
commercial
pet
food
and
other
processed/
stored
products,
the
accurate
determination
and
portrayal
of
any
risk
is
critical
to
the
user
community
and
the
public
in
the
perception
about
the
safety
of
its
continued
use.
The
Agency
cannot
assess
these
comments
in
detail
without
specific
examples.
In
general,
it
should
be
noted
as
described
in
Section
6.1.1.1
of
the
risk
assessment
(
see
PERFUM
model
inputs)
that
4
different
application
rates
were
considered
along
with
10
different
loss
rates
from
treated
structures.
Eleven
different
structure
sizes
were
also
considered
in
the
~
300,000
model
results
that
were
generated
(
see
Table
6
of
assessment).
With
these
numbers
of
possible
scenarios
for
consideration
it
is
unlikely
that
a
use
situation
similar
to
those
of
concern
has
not
been
addressed.
8
#
ID
Public
Comment
Agency
Response
32
PFI
We
support
the
comments
that
the
MBIP
is
submitting
to
EPA
on
the
risk
assessment
at
issue
and
urge
EPA
to
refine
its
assessment
before
making
any
final
decisions
affecting
the
continued
use
of
the
product.
Specifically,
the
Agency
makes
a
number
of
assumptions
on
the
rates
of
application,
methods
of
use
and
other
use
practices
for
methyl
bromide.
These
assumptions
do
not
reflect
typical
use
practices.
In
addition,
a
number
of
the
Agency's
proposed
mitigation
measures
do
not
take
into
account
the
wide
variation
in
the
structures,
facilities
and
sites
application
that
are
at
issue
here.
These
issues
are
more
fully
discussed
below.
See
response
#
31.

33
PFI
Based
on
the
EPA's
assumptions
about
use
practices,
PFI
is
concerned
that
EPA
has
not
adequately
reviewed
or
incorporated
the
historical
usage
information
previously
provided
by
the
user
community.
The
Agency's
assumptions,
therefore,
have
resulted
in
a
risk
assessment
that
overestimates
exposure
and
potential
risks.
Given
the
importance
of
methyl
bromide
as
a
critical
commodity
protection
tool,
and
that
no
alternatives
exist
for
pet
food
manufacturers
in
particular,
EPA's
risk
determinations
must
be
more
accurate
and
mitigation
measures,
if
any
are
adopted,
must
be
appropriate
to
the
level
of
risk.
Thus,
it
is
critical
that
EPA
refine
its
risk
assessment
to
reflect
accurate
data
on
use
patterns,
rates,
and
methods
of
application
See
response
#
31.

34
NAMA
On
the
subject
of
residues,
it
is
worth
noting
that
this
association
funded
a
methyl
bromide
residue
study
in
1993
to
meet
EPA
requirements.
Despite
the
earlier
Comments
of
the
North
American
Millers'
Association
comments
about
methyl
bromide
not
being
used
to
fumigate
raw
grain,
in
this
study
grain
was
fumigated
with
the
compound
in
order
to
generate
worst­
case
scenario
data.
Also,
the
fumigant
was
applied
at
a
highly
exaggerated
rate
of
8.0
lb.
per
1000
cubic
feet.
Still,
there
was
no
measurable
methyl
bromide
in
any
of
the
processed
fractions
(<
0.25
parts
per
million)
The
Agency
agrees
that
the
residues
for
processed
grain
fractions
would
be
very
low.

35
NAMA
We
are
concerned
that
EPA's
risk
assessment
is
based
on
assumptions
regarding
facility
preparation,
use
rates,
and
application
techniques
that
do
not
reflect
actual
use
practices.
Further,
we
believe
those
errors
may
have
distorted
the
agency's
assessment.
Some
of
EPA's
proposed
mitigation
measures
would
not
be
technically
or
economically
feasible,
or
would
not
add
measurably
to
the
profile
of
safe
usage
for
this
fumigant.
Since
this
comment
does
not
specify
what
assumptions
are
errors,
the
Agency
can
not
respond.
Furthermore,
the
Agency
has
solicited
comments
of
all
stakeholders
through
the
public
process
and
has
incorporated
data
on
facility
preparation,
use
rates,
and
application
techniques
in
the
revised
risk
assessment.
36
CDPR
CDPR
staff
agrees
with
U.
S.
EPA's
approach
of
using
monitoring
data,
Industrial
Source
Complex­
Short
Term
3
(
ISCST3)
modeling,
and
Probabilistic
Exposure
and
Risk
model
for
Fumigants
(
PERFUM)
modeling
to
assess
the
bystander
exposure
from
methyl
bromide
commodity
fumigations.
U.
S.
EPA
appears
to
have
used
the
appropriate
data
and
model
inputs
to
assess
the
exposure.
However,
input
files
for
the
PERFUM
runs
were
not
available
for
review.
Therefore,
this
review
will
assume
those
inputs
were
appropriate.
Given
the
described
inputs,
the
PERFUM
results
generally
appear
reasonable.
The
range
of
model
inputs
covers
the
great
majority,
but
not
all
of
the
commodity
fumigation
scenarios
in
California.
The
fumigation
scenarios
not
included
in
U.
S.
EPA's
assessment
would
not
significantly
impact
the
conclusions.
The
Agency
concurs
with
the
comment.
If
so
desired
PERFUM
inputs
and
output
files
could
be
provided
for
review.

37
CDPR
U.
S.
EPA
should
consider
separate
PERFUM
simulations
for
day
and
night
aeration
for
a
few
scenarios.
Unlike
emissions
from
field
fumigations
that
occur
for
several
hours
or
days,
emissions
during
commodity
aeration
occur
in
a
few
minutes
or
hours.
Due
to
the
more
stable
atmospheric
conditions
at
night,
air
concentrations
and
the
resulting
distribution
of
buffer
zone
distances
during
the
day
are
very
different
from
those
at
night.
PERFUM
outputs
were
calculated
using
different
durations
of
exposure
as
appropriate
for
the
various
scenarios
modeled
as
described
in
Section
6.1.1.1
(
see
"
Treatment
Frequency
&
Emission
Profiles").
The
durations
considered
range
from
1
to
24
hours
depending
upon
the
commodity
treated.
Most
scenarios
are
based
on
either
1
or
4
hour
exposures.
PERFUM
outputs
were
calculated
for
these
short
durations
and
presented
over
entire
24
hour
intervals
(
in
the
PERFUM
output
files
which
can
be
provided)
so
results
could
be
reviewed
for
differing
times
of
the
day.
When
the
results
were
summarized,
the
period
which
provided
the
longest
calculated
buffer
distances
were
used
in
the
Agency's
risk
summaries
(
i.
e.,
typically
between
9PM
and
3AM).
If
so
desired,
PERFUM
outputs
could
be
provided
so
that
diurnal
patterns
could
be
further
evaluated.
Results
can
vary
by
as
much
as
hundreds
of
meters
at
the
upper
percentiles
of
exposure
with
late
9
#
ID
Public
Comment
Agency
Response
afternoons
tending
to
have
the
overall
shortest
predicted
distances.
38
CDPR
Page
21.
Indirect
Back­
Calculation
 
this
section
seems
to
give
the
impression
that
CDPR
used
the
back­
calculation
technique
for
forced
air
aeration
(
stacks,
building
vents,
etc.).
This
is
not
the
case.
CDPR
used
fumiscope
readings
taken
during
aeration
to
characterize
the
release
of
MeBr
from
commodity
fumigations.
Those
measurements
were
used
directly
to
model
air
concentrations
at
receptor
locations
that
matched
sampler
locations
in
the
monitoring
studies.
The
Agency
acknowledges
this
comment
provided
a
correct
description
of
how
DPR
used
this
information
in
a
July
12,
2006
addendum
document
that
is
included
in
the
docket.

39
CDPR
Page
22.
Figure
1.
figure
1
does
not
seem
to
match
the
discussion.
Page
22.
" 
unsettled
conditions
may
reduce
risk
estimates
but
it
is
believed
that
even
these
conditions
can
result
in
conservative
estimates
because
wind
direction
is
constrained
to
a
single
vector
over
the
period
of
concern."
Although
the
text
is
unclear,
unsettled
conditions
likely
refer
to
stability
classes
A
and
B
(
unstable)
where
significant
vertical
mixing
can
produce
lower
air
concentrations
due
to
dilution
of
pollutants
in
the
air.
For
stack
releases,
in
the
absence
of
building
effects,
the
highest
maximum
air
concentrations
are
associated
with
unstable
conditions
because
looping
of
the
released
plume
can
cause
localized
touchdown
of
the
concentrated
plume.
Stable
conditions
produce
maximum
air
concentrations
the
farthest
from
the
stack
but
the
magnitude
of
that
maximum
air
concentration
will
be
lower
than
for
unstable
conditions.
The
purpose
of
Figure
1
is
to
illustrate
the
basic
premise
of
the
Gaussian
approach
in
ISCST3.
The
citation
for
Figure
1
would
probably
have
been
better
on
the
previous
page
where
there
is
a
more
general
discussion
of
ISCST3
presented.
The
Agency
also
concurs
with
the
characterization
language
provided.
The
intent
of
the
original
text
was
to
indicate
that
a
constrained
wind
direction
could
contribute
significantly
to
the
conservativeness
that
could
be
associated
with
ISCST3
results
as
it
had
been
used
in
the
Agency's
earlier
assessment.
40
CDPR
Page
26.
Scenario
3
 
Aeration
with
Stack.
It
appears
that
only
stacks
that
are
influenced
by
building
effects
were
modeled
in
this
scenario.
This
is
equivalent
to
CDPR
minimum
stack
analysis.
The
building
effects
parameters
should
be
specified
so
the
reader
understands
the
dimensions
of
the
generalized
building
used
in
these
simulations.
In
addition
to
the
minimum
stack
case,
CDPR
also
has
standard
stack
specification
requirements
(
height,
exit
velocity,
mass
of
MeBr
released,
height
differential
with
surrounding
buildings)
that
result
in
no
air
concentrations
at
ground
level
exceeding
the
desired
air
concentration
threshold.
This
means
that
the
buffer
zone
would
be
0
meters
for
all
stacks
meeting
the
standard
stack
requirements.
In
Section
6.1.1.1
of
the
risk
assessment
(
under
PERFUM
model
inputs)
the
different
treated
structures
that
were
considered
in
this
assessment
are
described.
Further
information
could
be
provided
upon
request
along
with
the
PERFUM
input/
output
files
which
would
provide
all
necessary
details
pertaining
to
these
factors.
The
Agency
also
concurs
that
only
a
minimum
stack
approach
has
been
used.
There
are
any
number
of
model
permutations
that
are
possible
in
the
standard
stack
height
approach,
as
such,
only
a
minimum
stack
approach
was
considered
in
the
assessment.
Possible
use
of
the
standard
stack
height
approach
for
additional
PERFUM
analyses
during
the
risk
management
phase
of
the
Agency
process
may
be
considered
if
necessary
and
appropriate
input
factors
can
be
determined.
41
CDPR
Page
27.
Scenario
5
 
Aeration
with
Mobile
Ground
Level
Source
not
near
Building.
It
is
not
clear
how
this
release
is
made.
If
the
tubing
is
pointing
horizontally
rather
than
vertically
then
the
vertical
exit
velocity
is
zero.
If
the
release
is
horizontal
then
that
should
be
clearly
stated.
There
is
discussion
on
the
SCRAM
website
on
how
to
best
model
horizontal
releases.
See
Model
Clearinghouse
Memo
93­
II­
09.
The
Agency
evaluated
possible
implications
of
the
suggested
modeling
approach.
The
July
12,
2006
addendum
further
addresses
this
issue.

42
CDPR
Page
28.
Stack
Diameters.
Was
the
assumption
that
the
`
very
large
diameter
stacks"
produce
reasonably
realistic
results
tested?
The
interaction
of
the
stack
diameter
with
build
effects
should
be
at
least
discussed.
This
interaction
could
significantly
affect
the
estimates.
For
stack
releases
the
building
effect
algorithm
adjusts
the
release
height
according
to
the
ratio
between
the
exit
velocity
of
the
plume
and
the
wind
speed.
The
exit
velocity
is
a
function
of
the
exchange
rate
(
cubic
ft/
min)
and
the
diameter
of
the
stack.
So,
the
exit
velocity
resulting
from
the
unrealistically
large
diameter
combined
with
the
required
air
exchange
(
e.
g.,
1.0,
0.5.
0.05
air
exchanges/
min)
may
not
be
appropriate.
The
Agency
acknowledges
this
comment
provided
further
characterization
language
in
the
July
12,
2006
addendum
on
this
issue.
It
should
also
be
noted
that
PERFUM
constrains
the
Agency
to
completing
the
analysis
using
a
single
stack
with
varying
diameter,
where
the
value
is
proportional
to
the
volume
of
the
structure
being
aerated,
exit
velocities,
and
the
air
exchange
rates.
This
is
because
PERFUM
only
provides
outputs
for
a
single
stack
and
not
multiple
sources.
43
MBIP
The
MBIP's
most
significant
comment
relates
to
the
no
stack
scenarios.
In
these
scenarios,
EPA
used
3
feet
as
the
release
height
for
all
of
the
building
area
sources,
despite
the
fact
that
the
larger
buildings
were
considerably
higher.
Therefore,
the
release
height
does
not
match
the
building
dimensions
(
although
CDPR
found
that
lower
heights
worked
better).
When
the
stack
is
set
at
higher
heights,
there
is
greater
dispersion
in
the
plume
before
it
reaches
the
ground,
resulting
in
lower
concentrations.
According
to
CDPR
(
CDPR
1994),
using
a
release
height
of
3
feet
overestimated
The
Agency
acknowledges
that
there
are
many
possible
permutations
and
situations
that
could
serve
as
a
modeling
context
for
methyl
bromide
including
the
one
described
in
this
comment.
The
Agency
also
acknowledges
that
there
would
be
extreme
difficulties
in
attempting
to
seal
a
facility
during
treatment
and
not
have
10
#
ID
Public
Comment
Agency
Response
the
concentrations
when
attempting
to
model
a
building
fumigation.
Therefore,
a
release
height
equal
to
half
of
the
building
height
may
be
more
appropriate,
to
account
for
the
fact
that
not
all
of
the
fumigant
will
be
released
from
the
top
of
the
building.
The
results
below
illustrate
the
impact
of
adjusting
the
release
height
to
the
full
building
height
and
half
of
the
building
height
for
a
100,000
ft3
building.
This
example
assumes
100%
of
4lbs/
1000ft3
application
rate
released
in
one
hour
and
a
four
hour
exposure
period.
If
a
more
reasonable
release
height
is
assumed,
the
buffer
zones
are
reduced
to
zero.
releases
around
windows
and
vents,
etc.
from
larger
buildings.
However,
it
appears
that
the
goal
in
the
industry
is
to
seal
structures
as
tightly
as
possible
during
treatment
which
is
represented
in
the
scenario
developed
by
the
Agency.
Such
facilities
also
always
have
ground
level
entryways
which
are
the
basis
for
the
3
feet
release
height
(
i.
e.,
basically
the
middle
of
a
standard
doorframe).
Based
on
the
Agency's
inquiries
into
the
types
of
facilities
used
in
commodity
treatments
there
are
many
structures
that
would
not
appear
to
emit
methyl
bromide
at
heights
greater
than
the
size
of
a
door
such
as
solid
concrete
grain
elevators
or
windowless
large
warehouses.
It
should
also
be
noted
that
in
the
no
stack
aeration
scenarios
only
passive
aeration
was
modeled
and
in
many
real­
world
cases
active
aeration
would
be
used
after
treatments
are
complete
for
larger
facilities
where
the
height
of
the
structure
could
significantly
impact
results.
In
these
situations,
the
active
aeration
predicted
buffer
distances
would
be
longer
than
what
would
be
anticipated
for
the
no
stack
aeration
estimates
because
the
total
mass
percentage
loss
would
be
greater
during
aeration
(
where
the
intent
is
to
emit
methyl
bromide)
opposed
to
during
treatment.
44
MBIP
Another
issue
that
should
be
investigated
is
the
higher
buffer
zones
obtained
for
the
PPQ
scenarios
during
the
daytime
hours.
Typically,
conditions
are
more
conducive
to
dispersion
during
the
daytime.
Therefore,
these
results
are
counterintuitive
and
may
reflect
an
error
in
EPA's
assessment.
See
response
#
37.

45
MBIP
Whole
Field
v.
Maximum
Concentration
Approach
­­
Pages
29­
30.
The
MBIP
believes
that
exposure
should
be
assessed
on
the
basis
of
a
population,
not
a
single
individual.
Although
specification
of
the
exposed
population
is
not
entirely
straightforward,
the
PERFUM
model
defines
the
population
in
the
most
constrained
way
possible.
The
population
only
includes
the
locations
around
the
buffer
zone
perimeter.
As
one
moves
away
from
the
perimeter,
the
concentrations
fall
and
defining
the
population
as
alternatively
being
some
distance
from
the
site
beyond
the
buffer
zone
would
have
resulted
in
smaller
values.
Going
the
other
way,
it
is
clearly
inappropriate
to
include
those
locations
inside
the
buffer
zone,
as
these
locations
will
be
protected
from
exposures
while
the
buffer
zone
is
in
place.
For
all
of
these
reasons,
the
PERFUM
model
(
using
the
whole
field
rather
than
the
maximum
buffer
approach)
defines
the
population
in
the
most
conservative
manner
possible
and
is
the
approach
that
should
be
used.
(
see
MBIP's
comments
on
page
8
for
rest
of
text
on
this
issue)
The
Agency
appreciates
the
information
provided
by
this
commenter
and
has
considered
this
information,
along
with
other
pertinent
data,
in
its
decision
regarding
the
use
of
PERFUM
modeling
results.

46
MBIP
 
PERFUM
Modeling
Method
­­
Page
32
Because
of
the
conservative
assumptions
in
other
areas
of
the
risk
assessment,
the
95th
percentile
is
sufficiently
protective.
While
we
agree
that
the
PERFUM
Model
is
the
best
approach
among
the
three
modeling
methods
presented
in
the
Post­
Harvest
RA,
PERFUM
outputs
should
only
be
used
to
determine
the
relative
effectiveness
of
various
mitigation
measures,
and
not
to
set
prescriptive
buffer
zones.
(
see
MBIP's
comments
on
page
9
for
rest
of
text
on
this
issue)
see
response
#
45.

47
MBIP
To
provide
more
information
about
concentrations
following
fumigant
applications,
the
MBIP
has
gathered
downwind
measurements
of
methyl
bromide
concentrations
following
recent
commodity
fumigations.
Clearly,
the
comparison
of
the
monitoring
data
and
modeling
results
for
the
flour
mill
site
warrant
further
evaluation
and
support
the
MBIP's
view
that
the
PERFUM
Model
should
not
be
used
to
generate
onerous
buffer
zones
for
all
types
of
commodity
fumigation
The
Agency
is
evaluating
the
possible
implications
of
the
monitoring
data
and
modeling
approach
described
in
the
comment.
The
July
12,
2006
addendum
further
addresses
this
issue.

48
APHIS
The
monitoring
data
supplied
by
the
California
Department
of
Food
and
Agriculture
for
evaluation
by
EPA
are
nearly
20
years
old.
Over
the
past
20
years
there
have
been
improvements
in
fumigation
procedures
and
technology,
including
thicker
and
more
durable
tarpaulins,
APHIS
PPQ
requirements
for
changing
tarpaulins
after
a
number
of
fumigations,
more
effective
methods
of
sealing
the
The
Agency
acknowledges
this
comment
with
regard
to
the
available
monitoring
data.
In
essence,
the
Agency
used
all
of
the
monitoring
data
which
were
available
along
with
modeling
approaches
to
11
#
ID
Public
Comment
Agency
Response
tarpaulins
to
the
ground
to
prevent
leakage,
stricter
requirements
regarding
the
type
of
ground
surface
used
for
fumigation,
and,
monitoring
to
ensure
that
ambient
air
concentrations
do
not
exceed
5
ppm
beyond
the
30
foot
buffer
during
treatment
or
the
200
foot
buffer
during
aeration.
The
California
monitoring
data
are
not
accompanied
by
fumigation
conditions
and
are
therefore
difficult
to
interpret.
Specifically,
was
the
commodity
being
treated
under
a
tarp?
What
kind?
How
thick?
Did
it
have
holes
or
cracks?
How
was
it
sealed
to
the
floor?
What
kind
of
flooring
was
under
the
tarp?
(
Wood
floors
leak
and
are
not
permitted
under
APHIS
supervision.)
Was
it
a
cement
floor
with
cracks
and
gaps?
Was
a
halide
detector
used
after
gas
introduction
to
ensure
that
the
tarp
was
holding
the
gas
(
standard
APHIS
PPQ
protocol)?
In
some
cases,
the
ambient
air
concentrations
from
the
California
monitoring
data
are
so
high
that,
were
it
to
occur
under
APHIS
supervision,
the
operation
would
have
to
be
ceased
until
the
leaks
were
remedied.
APHIS
appreciates
the
difficulty
of
attempting
to
model
ambient
air
concentrations;
however,
if
EPA
is
going
to
change
the
buffers
and
consequently
the
manner
in
which
all
fumigators
at
our
nation's
ports
of
entry
conduct
their
business,
then
the
model
should
be
supported
by
new
monitoring
data
that
reflect
current
fumigation
technology
and
that
indicate
that
ambient
air
concentrations
exceed
a
safe
level.
produce
an
overall
risk
picture
for
methyl
bromide
commodity
uses.
The
questions
raised
by
APHIS
regarding
the
specifics
of
the
monitoring
studies
are
pertinent
and
may
or
may
not
have
resolution.
With
regard
to
modeling,
the
Agency
has
used
a
variety
of
treatment
conditions
(
e.
g.,
retention
&
emission
rates)
as
described
in
Section
6.1.1.1
of
the
risk
assessment.
The
emission
factors
range
from
1
to
100
percent
of
the
material
being
emitted
from
a
treated
structure
which,
by
definition,
encompasses
all
manner
of
commodity
treatments
from
those
done
with
the
latest
technology
(
e.
g.,
thick
tarps,
good
sealing
methods,
etc.)
to
those
that
are
less
than
desirable.

The
Agency
has
also
described
in
its
risk
mitigation
options
a
possible
approach
that
would
allow
site
specific
monitoring
to
be
used
in
conjunction
with
other
factors
to
possibly
seek
relief
from
a
buffer
zone
approach.
This
option
it
should
be
noted
is
still
tentative.
49
Royal
Application
Site­
specific
Fumigation
Management
Plans.
In
Royal's
experience,
a
requirement
of
fumigation
management
plans
for
any
type
of
fumigation
is
logical
and
feasible.
Royal
and
its
colleagues
(
Royal
is
a
founding
member
of
the
Food
Protection
Alliance,
an
association
of
fumigators
that
serves
the
U.
S.,
Canada
and
Mexico1)
already
use
fumigation
management
plans,
and
the
manufacturers
of
fumigants
offer
model
plans
in
their
stewardship
training
and
on
their
web
sites.
The
associated
cost
of
this
proposal,
therefore,
would
be
the
cost
of
the
training
necessary
to
the
development,
execution
and
documentation
of
the
plans.
The
Agency
appreciates
the
information
provided
by
this
commenter
and
has
considered
this
information,
along
with
other
pertinent
data,
in
its
decision
regarding
the
use
of
FMPs.

50
USA
Rice
EPA
has
suggested
the
use
of
Fumigation
Management
Plans
(
FMPs)
for
methyl
bromide
fumigations.
These
plans
were
introduced
with
the
re­
registration
of
phosphine.
Good
planning
and
monitoring
are
critical
to
any
fumigation
job.
Although
formal
written
plans
may
not
have
been
a
requirement
on
past
product
labeling,
good
planning
and
monitoring
have
always
been
part
of
a
properly
conducted
fumigation.
With
proper
planning
and
monitoring
in
place,
human
exposure
concerns
can
be
addressed
before
the
treatment
begins.
FMP
requirements
now
in
place
for
phosphine
were
designed
to
ensure
that
facility
management
and
the
certified
applicator
were
working
together
to
ensure
a
safe,
legal,
and
effective
fumigation.
USA
Rice
supports
FMPs
for
use
on
MeBr.
See
response
#
49
51
Western
A
Fumigation
Management
Plan
is
essential
to
a
properly
conducted
fumigation
operation.
We
endorse
the
Fumigation
Management
Plan
outline
that
has
been
developed
for
phosphine
based
fumigants
as
well
as
Pro
Fume
fumigants.
See
response
#
49
52
NRDC
Application
site­
specific
fumigation
management
plans.
EPA
proposes
to
require
comprehensive
site­
specific
plans
to
be
submitted
prior
to
application
of
MBr,
to
encourage
fumigators
to
anticipate
and
evaluate
factors
that
may
lead
to
off­
site
or
unintended
exposure
to
MBr.
We
are
unconvinced
that
such
a
requirement
will
significantly
reduce
unsafe
exposures.
In
addition,
such
a
plan
is
unlikely
to
have
a
significant
effect
on
mitigating
environmental
releases
that
are
damaging
to
the
ozone.
Has
EPA
estimated
the
impact
of
this
proposal
on
MBr
use
and
release?
Does
EPA
have
data
supporting
its
estimated
impact?
If
so,
what
is
the
source
of
this
data,
and
what
are
the
costs
associated
with
this
proposal
compared
with
the
estimated
impact
on
MBr
total
usage?
Has
EPA
evaluated
the
impact
of
this
restriction
on
the
attractiveness
of
alternative
pest
control
methods?
See
response
#
49
53
FS&
S
Application
Site­
specific
Fumigation
Plans:
In
review
of
methyl
bromide
[
100%]
product
labels
you
will
notice
10
­
19
pages
of
instruction,
direction,
product
management
and
dosage
tables.
Please
also
notice
that
only
3
to
6
pages
of
this
document
actually
address
how
to
prepare
and
safely
use
this
biocide.
These
few
instructional
pages
cover
diverse
and
wide
ranging
applications.
It
is
important
to
realize
that
this
product
has
no
odor,
is
colorless
and
comes
in
a
gaseous
form.
I
believe
the
current
labels
for
methyl
bromide
do
not
adequately
protect
operators
and
bystanders
to
the
level
of
product
management
needed
for
continued
safe
use
of
For
decades
we
have
been
provided
with
methyl
bromide
application
labels
/
manuals
with
very
gray
areas
of
usage
requirements.
This
has
yielded
unsafe
and
questionable
usage
habits
by
many
fumigators.
As
an
example
 
phosphine
experienced
similar
but
less
dramatic
labeling
gray
areas.
See
response
#
49
12
#
ID
Public
Comment
Agency
Response
Phosphine
is
being
managed
much
better
with
the
implementation
of
a
Fumigation
Management
Plan
[
FMP].
This
document
has
removed
these
gray
areas
by
making
each
application
site
specific
and
situational
recognition
is
forced.
The
methyl
bromide
alternative
sulfuryl
fluoride
also
mandates
a
FMP
very
similar
to
phosphine.
I
believe
increased
operator
and
bystander
safety
is
the
result.
Additionally,
current
methyl
bromide
labels
make
space
fumigation
dosage
rates
unclear.
These
clarifications
have
been
removed
over
the
last
several
years.
Clarification
of
dosage
is
needed
along
with
recognition
and
control
over
additional
gas
needed
after
initial
release.
Many
methyl
bromide
space
fumigations
require
additional
gas
to
be
reintroduced
after
the
initial
application
to
achieve
efficacy.
This
"
add
gas"
can
be
abused
by
compromising
difficult
sealing
and
"
just
use
more
gas."
This
is
another
level
of
management
needed
and
will
more
directly
improve
bystander
safety.
Education
and
enforcement
of
these
new
standards
are
needed
in
order
to
protect
operators
and
bystanders.
States
need
to
be
informed
and
trained
regarding
these
changes.
Educational
materials
must
be
updated
in
a
timely
manner
so
continuing
education
programs
can
bring
licensed
users
up
to
date
with
new
standards
quickly.
Changes
have
taken
too
long
to
transfer
to
the
applicators
in
the
past.
The
cost
to
implement
these
increased
management
standards
would
be
minimal
but
this
should
have
been
mandated
from
the
beginning.
As
a
fumigator
still
using
methyl
bromide
for
quarantine
and
preshipment
uses
only
­
I
can
tell
you
that
filling
out
an
FMP
for
this
product
takes
only
a
few
minutes
per
application.
such
a
dangerous
compound.
54
NAMA
Fumigation
management
plans
The
milling
industry
has
an
excellent
record
of
safe
pesticide
usage.
Still,
we
are
committed
to
making
incremental
improvements
wherever
practical,
and
were
closely
involved
in
developing
the
concept
for
the
fumigation
management
plan
for
aluminum
and
magnesium
phosphide.
Fumigation
management
plans
have
also
been
incorporated
into
the
usage
rules
for
sulfuryl
fluoride,
the
most
recently
approved
space
fumigant.
We
believe
consolidating
all
best
practices
into
one
easily
usable
document
adds
to
safe
usage,
and
support
the
development
of
a
fumigation
management
plan
for
methyl
bromide.
See
response
#
49
55
MBIP
In
the
Risk
Mitigation
Memo,
EPA
states
that
it
sees
comprehensive
site­
specific
fumigation
management
plans
as
a
potentially
valuable
risk
reduction
option.
The
MBIP
agrees.
The
requirement
for
a
written
fumigation
plan,
known
as
an
FMP,
is
a
requirement
for
other
fumigants
 
particularly
phosphine
and
aluminum
and
magnesium
phosphide.
The
FMP
requirement
for
phosphine
was
implemented
in
late
2003
as
part
of
the
reregistration
process.
Formal
written
plans
are
not
required
to
be
submitted
to
regulatory
authorities.
However,
the
FMP
requirements
require
the
fumigator
and
facility
management
to
engage
in
good
planning
and
monitoring
to
ensure
safe
and
effective
fumigation.
Although
formal
written
plans
are
not
imposed
as
a
requirement
on
methyl
bromide
product
labeling,
fumigators
already
use
planning
and
monitoring
to
mitigate
risk.
FMP
requirements
now
in
place
for
phosphine
were
designed
to
ensure
that
facility
management
and
the
certified
applicator
were
working
together
to
ensure
a
safe,
legal,
and
effective
fumigation.
The
FMPs
have
resulted
in
documented
safe
and
efficacious
treatments.
The
MBIP
generally
supports
the
development
of
FMPs
for
methyl
bromide.
See
response
#
49
56
APHIS
For
the
health
and
safety
of
all
employees
at
the
port,
and
to
ensure
that
Federal
phytosanitary
regulations
are
appropriately
met,
APHIS
PPQ
already
has
a
process
in
place
to
certify
all
fumigation
sites
where
commodities
are
treated
under
APHIS
regulation.
APHIS
PPQ
considers
this
process
to
be
safe
and
adequate.
The
fumigation
site­
certification
process,
which
can
also
be
described
as
a
site­
specific
plan,
may
be
found
in
Chapters
2­
4
of
the
APHIS
PPQ
Treatment
Manual
at
http://
www.
aphis.
usda.
gov/
ppq/
manuals/
port/
Treatment_
Chapters.
htm.
To
summarize,
fumigation
site­
certification
is
obtained
by
a
thorough
evaluation
of
the
facility
by
a
PPQ
officer;
this
includes
evaluating
its
location
in
relation
to
other
port
workers
and
nearby
population
centers.
Two
forms
must
be
completed:
A
Compliance
Agreement
(
PPQ
Form
519;
Attachment
1),
which
is
signed
by
the
owner
of
the
fumigation
company,
and,
in
the
case
of
non­
tarped
fumigations
(
i.
e.
chambers),
a
detailed
evaluation
of
the
site­
specific
facility,
(
PPQ
Form
480;
Attachment
2)
which
is
kept
on
file
by
APHIS
PPQ.
Tarped
enclosures
are
evaluated
each
time
a
fumigation
occurs
using
the
back
page
of
PPQ
Form
429
(
see
Treatment
Manual,
page
A­
1­
12
at
http://
www.
aphis.
usda.
gov/
ppq/
manuals/
port/
pdf_
files/
Treatment_
Chapters/
A­
AAppendixA
pdf).
The
Compliance
Agreement
contains
specific
and
detailed
Operational
Procedures
by
which
the
fumigator
is
obligated
to
abide
(
page
2
of
3
in
Attachment
1).
Failure
to
abide
by
the
operational
procedures
specified
in
the
Compliance
Agreement
could
cause
the
fumigator
to
loose
the
right
to
fumigate
APHISSee
response
#
49
13
#
ID
Public
Comment
Agency
Response
regulated
commodities
unless
the
failure
is
corrected;
a
fumigator
whose
major
source
of
income
is
through
import
commodity
fumigation
has
an
incentive
to
comply.
Non­
compliant
fumigators
may
also
be
subjected
to
costly
sanctions
under
the
Plant
Protection
Act,
APHIS
PPQ's
enabling
legislation.
For
the
health
and
safety
of
those
in
the
immediate
area,
Part
J
(
page
2
of
3)
of
the
Compliance
Agreement,
states,
"
The
PPQ
officer's
decision
is
final
and
under
no
circumstances
will
it
be
revoked
by
others."
APHIS
is
not
in
support
of
EPA
regulations
which
may
be
inconsistent
with
this
authority
of
APHIS
PPQ.
PPQ
Form
480
is
filled
out
for
every
non­
tarped
enclosure
(
i.
e.
chamber)
used
by
the
fumigation
company,
and
is
modified
every
time
any
feature
of
the
site
is
changed.
Since
many
fumigation
companies
work
in
different
locations,
there
may
be
several
facilities
evaluated
under
a
single
compliance
agreement
using
PPQ
Form
480.
For
tarped
enclosures,
all
APHIS
PPQ
employees
supervising
fumigation
use
a
checklist
located
on
the
back
page
of
PPQ
Form
429.
The
checklist
is
reviewed
for
each
fumigation.
APHIS
believes
that
the
PPQ
process
for
certifying
fumigation
facilities
are
more
rigorous
than
the
comprehensive
site
plans
developed
by
California.
It
addresses
all
the
safety
features
required
by
APHIS
for
safe
and
effective
fumigation,
including
the
ability
to
satisfy
the
APHIS­
imposed
buffer
requirements,
which
were
developed
by
evaluating
APHIS
PPQ
monitoring
data
on
ambient
air
concentrations
during
actual
fumigations.
Since
APHIS
PPQ
procedures
are
essentially
site
plans
for
facilities
being
used
to
fulfill
Federal
phytosanitary
requirements,
APHIS
questions
the
value
added
if
EPA
were
to
impose
the
additional
requirements
of
an
EPA
site
plan
on
these
particular
facilities.
57
Royal
Buffer
Zones.
Royal
observes
buffer
zones
in
all
of
its
operations;
therefore,
the
degree
to
which
buffer
zones
would
affect
its
fumigations
would
be
determined
by
the
degree
of
change
in
any
zone.
In
general,
Royal
believes
that
large
fumigations
would
be
affected
far
more
than
small
ones
by
increases
in
buffer
zones
because
of
the
difficulty
of
moving
or
expanding
the
area
of
large
fumigations.
Obviously,
moving
the
fumigation
is
not
an
option
in
the
case
of
structure
fumigation,
and
in
that
case
the
customer,
not
Royal,
would
have
the
information
on
probable
costs
of
obtaining
additional
land
or
other
measures
to
establish
a
larger
buffer
zone.
USDA
APHIS
approves
all
quarantine
fumigation
sites
for
tarpaulin
fumigation,
and
it
determines
the
buffer
zone
for
each
site.
Royal
has
measured
methyl
bromide
levels
within
the
buffer
zones
approved
by
APHIS
and
has
found
the
zones
adequate
to
protect
bystanders;
in
fact,
Royal
uses
similar
criteria
to
set
its
own
buffer
zones
for
non­
quarantine
fumigations.
The
Risk
Mitigation
Proposal
mentions
the
establishment
of
minimum
buffer
zones
for
all
applications.
Given
the
many
factors
that
impact
a
determination
of
a
buffer
zone,
Royal
questions
whether
it
is
possible
to
establish
minimum
buffer
zones
that
actually
lower
risk.
Royal
would
urge
that,
in
lieu
of
minimum
buffer
zones,
efforts
be
made
to
create
tools
for
individual
analysis
of
each
fumigation
site.
We
note
that
USDA
APHIS
has
inspectors
with
many
years'
experience
in
such
analyses,
and
the
fumigation
industry
also
has
experience
in
creating
analytical
tools,
such
as
Dow
Agro
Science's
Fumiguide
for
use
of
its
sulfuryl
fluoride
product,
ProFume.
As
noted
by
the
revised
risk
assessment,
factors
pertinent
to
buffer
zones
include
some
that
are
within
the
control
of
the
fumigator,
such
as
loss/
emission
rates
and
enclosure
types.
Royal
believes
that
if
fumigators
are
given
the
opportunity
to
prove
that
their
equipment
or
methods
lower
risk,
and
if
as
a
consequence
they
are
able
to
obtain
a
marketable
benefit
such
as
having
smaller
buffer
zones
apply
to
their
work,
this
will
provide
a
significant
incentive
for
improvement
in
the
industry.
This
also
mitigates
against
establishing
minimum
buffer
zones
in
a
"
one
size
fits
all"
fashion.
It
should
be
noted
that
fumigators
generally
are
not
in
a
position
to
address
the
costs
of
moving
fumigation
sites
or
cargo,
or
storing
cargo.
Commodity
fumigators
go
to
the
customer's
location
and
generally
do
not
have
access
to
the
type
of
financial
information
solicited
by
EPA
such
as
land
and
construction
costs.
Royal
can
offer
generally,
however,
that
storage
costs
for
dry
commodities
can
run
from
$
15­
30
per
container
per
day,
and
storage
costs
for
refrigerated
commodities
are
significant
(
especially
when
energy
costs
are
high),
if
such
storage
is
even
available.
It
is
Royal's
observation
that
cold
storage
facilities
near
the
ports
where
Royal
fumigates
now
operate
at
capacity
and
likely
could
not
accommodate
additional
storage
time
for
cargo
that
is
delayed
in
fumigation.
In
addition,
a
delay
in
the
fumigation
of
perishable
commodities
such
as
grapes
reduces
the
value
of
the
cargo.
We
have
been
told
that
each
day's
delay
in
fumigation
lowers
the
value
of
a
case
of
Chilean
grapes
by
one
dollar
(
cases
can
be
priced
in
the
range
of
$
7
to
$
28
depending
upon
market
and
fruit
conditions).
This
is
offered
as
anecdotal
APHIS
currently
enforces
the
5
ppm
limit
for
all
sites
except
California
which
is
higher
than
MeBr
levels
required
by
CDPR
and
those
that
the
Agency
is
now
considering
(
see
response
#
2).

Since
the
buffer
zone
concept
is
based
on
distance
where
concentrations
are
not
a
risk
concern,
it
seems
reasonable
to
assume
it
would
lower
risk
for
bystanders.

See
response
#
5.

The
Agency
also
acknowledges
that
the
specific
risk
mitigation
options
that
are
being
considered
would
likely
have
a
different
economic
effect
on
each
facility
that
conducts
fumigations.
Further,
the
Agency
agrees
that,
depending
on
the
particular
risk
mitigation
option
selected
and
the
site­
specific
conditions
of
the
facility,
some
options
could
produce
substantial
adverse
economic
effects.
14
#
ID
Public
Comment
Agency
Response
information
only,
as
we
are
not
aware
of
economic
analysis
to
support
it.
Royal
is
not
aware
of
any
port
that
has
space
to
increase
its
buffer
zones,
or
that
is
in
a
position
to
acquire
additional
land
for
its
use.
East
Coast
quarantine
fumigations
take
place
at
night,
when
other
port
personnel
are
not
present,
and
existing
buffer
zones
can
be
maintained
without
undue
interruption
of
other
port
business.
If
buffer
zones
are
materially
increased,
however,
or
if
fumigations
take
place
during
the
port's
regular
business
hours,
the
flow
of
commerce
will
be
interrupted
and
the
risk
of
bystander
exposure
will
increase.
It
may
be
that
other
risk
mitigation
measures,
such
as
portable
stacks
or
ventilation
equipment
that
directs
the
aeration
flow
to
specific
areas,
are
more
feasible
in
these
circumstances.
If
fumigation
with
methyl
bromide
is
not
feasible
at
all,
there
are
no
alternative
treatments
approved
for
quarantine
use
on
perishables
such
as
the
Southern
Hemisphere
fruit.
58
USA
Rice
The
agency
is
considering
the
use
of
buffer
zones.
While
some
facilities
may
be
able
to
handle
excessively
large
buffer
zones,
other
facilities
suffer
from
encroaching
industrial
parks
or
suburbia.
Current
fumigation
procedures
require
air
monitoring
around
the
site
and
this
works
well.
Large
buffer
zones
will
be
impracticable,
and
in
some
instances
the
zones
may
well
replace
air
monitoring
in
workers'
minds
as
the
primary
means
to
ensure
safety.
Air
monitoring
should
remain
in
the
fumigation
plan.
Compliance
with
buffer
zones
may
also
lead
to
reduced
application
rates,
insufficient
fumigation,
and
increased
costs.
The
Agency
agrees.
To
the
extent
possible,
adding
flexibility
to
the
mitigation
controls
required
is
being
considered
by
the
Agency.

59
Western
Buffer
Zones,
where
needed,
must
be
developed
on
a
site­
by­
site
basis.
Not
all
fumigations
are
conducted
under
similar
circumstances
and
a
one­
size
fits
all
buffer
zone
would
unnecessarily
eliminate
certain
fumigation
sites,
which
have
been
selected
out
of
operational
necessity.
A
viable
alternative
to
buffer
zones
is
the
active
monitoring
of
gas
concentration
in
a
fumigation
zone,
which
is
our
recommendation.
The
Agency
believes
that
many
sites
will
be
able
to
comply
with
buffer
zones
with
some
modifications.
However,
to
aid
those
sites
that
can
not,
the
Agency
has
provided
an
option
for
site­
specific
modeling
and/
or
collection
of
comprehensive
air
monitoring
data.
60
ASOEX
Buffer
Zones:
ASOEX
strongly
believes
that
the
establishment
of
"
buffer
zones"
is
unnecessary
for
quarantine
fumigations
because
APHIS
already
determines
that
the
perimeter
of
200­
250
mm
around
methyl
bromide
fumigations
is
a
buffer
zone
beyond
which
is
considered
to
be
safe.
ASOEX
is
not
aware
of
any
U.
S.
port
that
has
adequate
and
sufficient
space
available
to
increase
buffer
zones.
If
EPA
imposes
any
increase
in
the
existing
buffer
zones
established
and
mandated
by
APHIS,
such
buffers
could
have
adverse
and
serious
effects
not
only
on
Chilean
produce
exports
but
also
on
the
U.
S.
economy
as
APHIS
argued
precisely
in
its
October
17,
2005
letter
submitted
to
this
EPA
docket.
ASOEX
would
like
to
call
your
attention
to
the
following
adverse
effects
listed
by
APHIS:
°
Many
ports
would
experience
severe
losses
in
commerce.
A
port
like
Philadelphia,
which
specializes
in
the
importation
of
fresh
fruit
could
lose
most
of
their
business;
°
Fumigation
businesses
at
those
ports
of
entry
would
be
closed,
and
port
fumigators
would
lose
their
means
of
income;
°
Commodity
brokers
and/
or
importers
which
have
built
businesses
based
on
bringing
their
imports
into
those
ports
would
lose
income
from
importing
that
commodity;
°
Small
importers
may
lose
entire
businesses;
°
Local
businesses
which
depend
on
certain
imports
would
be
affected,
possibly
to
their
detriment.
HED's
risk
assessment
indicated
that
the
there
is
a
risk
concern
for
some
scenarios
at
current
perimeter
that
APHIS
establishes.

See
response
#
5.

The
Agency
also
acknowledges
that
the
specific
risk
mitigation
options
that
are
being
considered
would
likely
have
a
different
economic
effect
on
each
facility
that
conducts
fumigations.
Further,
the
Agency
agrees
that,
depending
on
the
particular
risk
mitigation
option
selected
and
the
site­
specific
conditions
of
the
facility,
some
options
could
produce
substantial
adverse
economic
effects.

61
NRDC
Buffer
Zones.
EPA
proposes
to
establish
buffer
zones
around
an
enclosure
or
structure
during
treatment
and
aeration
to
manage
risks
from
inhalation
exposure
to
workers
and
bystanders.
We
are
unconvinced
that
this
is
a
practical
or
effective
proposal.
EPA's
own
analysis
of
actual
monitoring
data
establishes
acute
risks
of
concern
to
bystanders
or
nearby
residents.
Moreover,
analyses
conducted
with
the
PERFUM
model
shows
that
concentrations
are
not
reduced
sufficiently
even
at
the
model's
maximum
limit
of
1440
meters
(
Fig
11,
p.
41,
p.
3).
Further,
it
appears
that
the
buffer
zone
modeling
was
conducted
for
a
fumigation
facility
far
smaller
than
numerous
commercially
operating
facilities.
As
a
result
of
the
much
larger
internal
volume
of
such
facilities,
the
total
amount
of
MBr
required
to
achieve
the
intended
fumigation
purpose
would
have
to
be
much
larger
than
the
amount
EPA
modeled
for
the
smaller
facility.
This
larger
volume
of
MBr
use
would
lead
to
the
need
for
an
even
larger
buffer
zone.
NRDC
requests
that
EPA
re­
model
the
bystander
concentrations
out
to
the
PERFUM
model's
distance
limit
for
the
largest
real­
world
fumigation
facilities
that
currently
use
MBr,
and
that
EPA
conduct
whatever
supplementary
modeling
is
necessary
to
determine
how
large
the
buffer
zones
would
have
to
be
to
guarantee
that
bystanders
will
not
be
exposed
to
unsafe
exposure
levels
from
facilities
of
real­
world
size.
Achieving
these
buffer
zones
 
some
as
yet
undetermined
distance
greater
than
1440
meters
­­
is
extremely
impractical.
The
result
is
that
significant
bystander
In
Section
6.1.1.1
of
the
risk
assessment
(
under
PERFUM
model
inputs)
the
different
treated
structures
that
were
considered
in
this
assessment
are
described.
These
include
volumes
from
1000
to
1
million
cubic
feet
which
encompass
the
vast
majority
of
methyl
bromide
treatments
for
commodity
and
industrial
purposes
conducted
in
the
United
States.
The
largest
facilities
that
the
Agency
is
aware
of
being
treated
are
approximately
10
million
cubic
feet.
NRDC
indicates
that
larger
structures
lead
to
bigger
amounts
of
methyl
bromide
being
used
for
treatments
which
can
lead
to
longer
buffer
distances.
This
is
often
the
case,
however,
this
does
not
necessarily
always
lead
to
longer
predicted
buffer
zones
because
larger
volume
structures
can
sometimes
have
lower
15
#
ID
Public
Comment
Agency
Response
populations
will
remain
at
risk
if
these
MBr
uses
are
reregisted.
The
EPA
reports
on
a
system
that
is
followed
in
California
by
the
CDPR
where
buffer
zones
individually
calculated
according
to
site­
specific
factors
that
are
included
in
permit
applications.
While
we
are
generally
supportive
of
plans
that
allow
flexibility
and
site­
specific
considerations,
in
the
case
of
MBr
the
result
as
been
predictable;
continued
bystander
poisoning
events
even
with
uses
that
comply
with
the
label.
buffer
distances
associated
with
them
than
smaller
volume
buildings
because
buffer
distances
are
calculated
based
on
distance
from
a
source
at
ground
level
where
the
characteristics
of
a
shorter
building
can
lead
to
higher
ground
level
air
concentrations.
Development
of
buffer
distances
longer
than
1440
meters
at
this
time
is
not
possible
with
PERFUM
and
would
require
a
modification
to
the
code
of
the
model.
This
model
has
been
reviewed
by
the
FIFRA
SAP
and
it
has
been
used
in
the
Agency's
assessments
for
fumigants;
it
is
not
an
Agency
model
so
modification
to
the
code
would
depend
on
its
developers.
Site
specific
model
analysis
is
an
option
that
for
defining
appropriate
buffer
distances
at
larger
facilities.
It,
along
with
other
options,
are
currently
under
review
and
may
or
may
not
ultimately
be
selected
as
an
option
for
managing
the
potential
risks
associated
with
methyl
bromide
use
(
HED/
SRRD)
62
FS&
S
Risk
Management
Option
2
­
Buffer
Zones:
I
believe
an
effective
FMP
will
recognize
spatial
need.
Fence
line
monitoring
[
down
wind]
should
be
mandatory
during
application,
maintenance
and
release
/
aeration
of
each
fumigation.
The
Agency
appreciates
the
information
provided
by
this
commenter
and
has
considered
this
information,
along
with
other
pertinent
data,
in
its
decision
regarding
the
use
of
buffer
zones.
63
PFI
On
the
question
of
buffer
zones,
PFI
is
concerned
that
if
EPA
applies
a
more
restrictive
requirement,
facilities
which
currently
depend
on
methyl
bromide
will
be
unable
to
use
it.
In
addition,
since
pet
food
processing
facilities
are,
in
most
cases,
quite
large,
any
restrictions
on
the
amount
of
methyl
bromide
that
may
be
used
in
a
certain
area
will
also
be
very
problematic
and
could
result
in
an
increase
in
methyl
bromide
fumigations
before
new
restrictions
are
in
place.
Although
the
Agency
believes
the
mitigation
approach
outlined
in
the
RED
offers
substantial
flexibility
for
sitespecific
solutions
that
are
protective
of
workers
and
bystanders,
it
also
recognizes
that
there
will
likely
be
some
commodity
fumigation
sites
where
MeBr
will
no
longer
be
practical
to
use.
64
NAMA
Buffer
zones
We
do
not
believe
buffer
zones
add
measurably
to
the
safe
usage
of
methyl
bromide,
and
oppose
the
establishment
of
large
buffer
zones.
During
and
after
a
fumigation
air
monitoring
is
conducted
and
security
personnel
are
posted
around
the
property
to
keep
bystanders
away.
History
shows
this
has
been
a
very
effective
management
practice.
Grain
milling
is
one
of
the
US'
oldest
industries,
and
as
a
result
there
are
many
old,
but
still
highly
productive,
mills
in
operation.
Because
of
their
age,
increased
urbanization
and
land
development
has
resulted
in
encroachment
toward
the
mills.
Large
buffer
zones
would
unnecessarily
preclude
the
use
of
MB
in
many
of
these
locations.
Relocating
mills
simply
to
accommodate
large
buffer
zones
is
not
economically
practical.
The
milling
industry
is
fully
mature
and
profit
margins
are
extremely
small
or
nonexistent.
The
few
new
mills
built
in
the
last
10
years
cost
in
excess
of
$
30
million.
Such
capital
expenditures
will
only
be
made
where
market
conditions
exist,
not
to
simply
allow
the
continued
usage
of
a
pesticide,
no
matter
how
useful
it
may
be.
During
fumigant
application
and
aeration,
air
monitoring
around
the
facility
perimeter
and
at
fence
lines,
similar
to
the
existing
requirements
for
phosphine,
remains
the
best
practice
for
ensuring
safety
for
the
neighboring
community.
See
response
#
8.

65
MBIP
The
MBIP
views
actual
air
monitoring
as
a
better
risk
mitigation
tool
for
commodity
fumigation
than
buffer
zones.
Excessively
large
buffer
zones
may
mean
that
neighboring
facilities
would
have
to
be
notified
and
evacuated
in
order
for
the
treatment
to
occur.
These
safety
precautions
would
not
add
measurably
to
the
safe
usage
of
methyl
bromide,
but
would
cause
unnecessary
hardships
and
burdens
on
facilities
and
fumigators.
The
true
focus
should
be
on
actual
air
monitoring
around
a
treated
site.
In
order
to
meet
buffer
zone
requirements,
facilities
may
be
forced
to
reduce
the
volume
treated
or
lower
application
rates.
Reduced
dosage
decreases
the
ability
of
fumigant
to
penetrate
into
harborage
areas
and
decreases
effectiveness
of
the
total
treatment.
Inability
to
treat
all
areas
of
a
food
handling
establishment
at
the
same
time
results
in
increased
downtime
for
the
facility
when
they
have
to
treat
areas
that
were
cut
The
buffer
zones
estimated
by
the
Agency
are
not
arbitrary.
See
response
#
61
regarding
the
range
of
scenarios
that
the
Agency's
modeling
includes.

Air
monitoring
results
alone
may
not
be
an
adequate
risk
mitigation
tool.
The
magnitude
of
samples
needed
to
adequately
measure
plume/
maximum
down­
wind
concentration
likely
to
be
prohibitive.
Even
a
modest
number
of
non­
detects
at
fence­
line
during
aeration
would
not
negate
predicted
buffers
with
16
#
ID
Public
Comment
Agency
Response
out
of
the
original
fumigation.
It
also
leads
to
unacceptably
increased
costs.
As
discussed
above,
administration
of
buffer
zones
would
be
a
significant
burden.
Moreover,
the
variability
among
fumigation
sites
would
lead
to
almost
infinite
possibilities
for
emission
models
upon
which
buffer
zones
are
based.
There
are
large
variations
from
facility
to
facility
in
height,
aeration
rate,
application
rate,
leakage
during
fumigation,
and
many
other
factors.
It
is
unlikely
that
a
manageable
number
of
standard
conditions
could
be
established
through
labeling.
However,
the
advent
in
recent
years
of
sensitive,
affordable,
electronic
analyzers
for
methyl
bromide
has
increased
the
ability
of
fumigators
to
conduct
real
time
monitoring
around
facilities
under
fumigation.
Label
language
requiring
monitoring
during
fumigation
and
aeration
to
demonstrate
that
methyl
bromide
concentrations
do
not
exceed
levels
deemed
to
be
acceptable
would
provide
both
a
higher
level
of
protection
and
greater
flexibility
than
arbitrary
buffer
zones.
modeling.
Air
monitoring
would
need
to
be
accompanied
with
weather
data,
emission
measurements,
and
revised
model
to
be
an
effective
mitigation
tool.

66
APHIS
APHIS
is
in
agreement
that
buffers
are
necessary
during
methyl
bromide
treatment
and
aeration,
and
believes
that
the
APHIS
PPQ
fumigation
requirements
that
were
established
over
20
years
ago
using
monitoring
data,
and
which
include
different
buffer
zones
for
treatment
(
30
feet)
and
aeration
(
200
feet
during
the
first
10
minutes),
are
safe
and
adequate
(
see
Chapters
2­
3,
2­
4,
2­
5,
2­
6,
2­
7,
and
2­
8
of
the
APHIS
PPQ
Treatment
Manual
at
http://
www.
aphis.
usda.
gov/
ppq/
manuals/
port/
Treatment_
Chapters.
htm).
Only
persons
wearing
a
Self­
Contained
Breathing
Apparatus
(
SCBA)
may
go
within
buffer
zones
during
those
times
if
the
gas
concentration
is
unknown.
The
policy
further
affirms,
in
accordance
with
the
label,
that
no
person
may
enter
an
area
without
SCBA
gear
if
air
concentrations
exceed
5
ppm.
This
APHIS
PPQ
policy
is
enforced
for
any
person
near
the
fumigation
site,
including
the
private
fumigators
performing
the
fumigation
and
the
APHIS
employees
supervising
the
fumigations.
see
response
#
62.

67
APHIS
APHIS
is
in
full
agreement
that
buffers
are
necessary
for
the
safety
of
all
port
workers;
buffers,
based
on
air
concentration
monitoring
data,
are
already
required
for
all
APHIS­
supervised
fumigations.
As
already
mentioned,
PPQ
requires
a
30
foot
buffer
during
treatment,
and
a
200
foot
buffer
during
the
first
10
minutes
of
aeration,
when
the
majority
of
fumigant
is
expelled.
These
values
were
put
in
place
after
PPQ
used
monitoring
data
to
determine
that
the
ambient
air
concentrations
never
exceed
5
ppm,
and
in
fact
are
often
below
the
level
of
detection
of
air
monitoring
devices
(
1
ppm)
at
these
distances.
Increased
buffer
zones
may
make
it
impossible
to
fumigate
in
some
ports
which
do
not
own
property
beyond
the
standard
200
foot
buffer.
Discontinued
import/
export
treatments
would
impact
the
local
economies.
APHIS
believes
that
any
changes
in
these
buffer
distances
should
be
supported
by
valid
monitoring
data
which
indicate
that
the
air
concentrations
exceed
a
safe
level.
APHIS
notes
that
California
regulations
require
buffers
which
permit
passers­
by
to
move
through
a
1,000
foot
buffer
without
SCBA
gear.
APHIS
PPQ
requires
that
the
fumigators
wear
SCBA
gear
within
the
30
foot
buffer
during
treatment
and
the
200
foot
buffer
during
aeration;
furthermore,
APHIS
monitoring
data
have
shown
that
the
air
concentration
levels
do
not
exceed
5
ppm
(
and
are
often
below
the
limit
of
detection
of
1
ppm)
outside
of
the
APHIS
PPQ
buffer
zones.
see
response
#
62.

68
Royal
Stacks
and
Fans.
In
Royal's
quarantine
fumigation
operations,
generally
two
types
of
stacks
are
used:
permanent
installations
in
buildings
(
often
referred
to
as
"
vent
towers"
or
chimneys)
and
portable
ductwork.
Older
warehouses
may
not
have
vent
towers,
but
where
they
do
exist,
the
towers
tend
to
be
the
height
of
the
building
roof,
which
can
be
as
low
as
18
feet,
or
30
feet
or
more.
The
Treatment
Manual
mandates
Public
Information
and
Records
Integrity
Branch
rates
of
air
flow
turnover
for
aeration,
as
a
result
of
which
Royal
has
seen
fan
ratings
of
40,000
cubic
feet
per
minute
in
certain
vent
towers,
but
this
is
offered
solely
as
an
example
and
may
not
apply
in
other
buildings
or
situations.
Again,
the
owners
of
the
facilities
where
fumigation
takes
place
are
better
able
to
address
specific
requirements
and
associated
costs.
Royal
is
aware,
however,
of
one
estimate
for
retrofitting
a
100,000
square
foot
dry
warehouse
to
add
vent
towers
at
approximately
$
30,000
per
tower.
We
do
not
know
whether
this
cost
includes
the
additional
venting
necessary
to
introduce
outside
air
into
a
building
when
vent
towers
operate.
In
assessing
the
costs
associated
with
the
use
of
towers,
it
should
be
noted
that
once
installed,
the
towers
may
limit
the
use
of
a
building
by
limiting
stowage
patterns
of
the
product
to
be
fumigated.
Where
no
stack
or
vent
tower
is
available,
Royal
uses
flexible
ductwork
and
multiple
exhaust
fans
(
generally
rated
at
a
minimum
of
10,000
cfm
each)
to
direct
ground­
level
aeration
to
areas
that
do
not
pose
a
risk
of
human
exposure.
In
these
cases,
the
ductwork
may
transport
the
methyl
bromide
several
hundred
feet
before
it
is
dissipated
into
the
general
atmosphere,
and
obviously
the
longer
the
ductwork,
the
more
powerful
the
fans
must
be.
This
method
can
be
used
to
channel
aeration
See
response
#
5.
17
#
ID
Public
Comment
Agency
Response
where
natural
conditions,
such
as
prevailing
winds,
would
otherwise
create
additional
risk
during
aeration.
Once
again,
the
Treatment
Manual
may
provide
guidelines
on
ventilation
requirements
and
calculations.
Royal
believes
that
EPA's
estimate
of
$
850
per
10,000
cfm
fan
is
probably
half
of
the
real
cost.
We
note
that
exhaust
fans
for
aeration
are
engineered
for
that
purpose
and
consequently
are
costly.
It
is
possible
to
purchase
a
10,000
cfm
fan
for
$
600
to
$
850,
but
it
will
not
be
adequate
for
aeration
of
fumigation
chambers.
On
the
subject
of
fumigation
equipment
in
general
Royal
does
not
believe
that
it
is
possible
or
advisable
to
establish
specific
equipment
standards,
even
for
one
particular
type
of
fumigation
such
as
tarpaulin
fumigation.
This
is
because
equipment
changes
over
time,
each
fumigation
is
unique
and
fumigators
must
tailor
their
equipment
to
the
needs
of
the
location.
As
just
one
example,
Royal
uses
fans
for
introduction
of
methyl
bromide
gas,
circulation
of
the
gas,
exhausting
the
gas
and
keeping
a
pattern
of
air
flow
in
a
warehouse
where
tarpaulin
fumigation
is
taking
place.
Each
use
may
dictate
not
just
different
cfm
ratings
but
different
fan
engineering
and
design,
and
each
fumigation
will
have
it
own
configuration
of
fans
for
each
purpose.
Through
years
of
experience,
testing
and
assessment
of
equipment,
fumigators
develop
the
most
effective
and
safest
fumigation
plans.
Some
fumigation
equipment
is
highly
specialized,
and
even
"
off
the
shelf"
equipment
may
be
employed
in
a
specialized
way.
Royal
believes
that
in
any
establishment
of
standards,
care
should
be
taken
to
preserve
the
fumigators'
ability
to
use
their
experience
and
judgment
through
providing
incentives
to
effective
and
safe
fumigators
who
work
to
improve
their
industry
and
safeguard
the
public.
69
USA
Rice
Exhaust
stacks
are
required
to
allow
mills
to
aerate
at
night;
otherwise
all
aeration
must
be
during
the
day.
This
would
require
many
mills
to
build
roof
mounted
exhaust
stacks,
close
sidewall
exhaust
vents
and
to
reorient
existing
exhaust
fans
to
push
air
upwards.
Those
mills
with
existing
stacks
may
not
have
stacks
that
meet
minimum
height
requirements
for
aeration
which
are
10
feet
over
the
mill's
highest
point
or
obstruction
within
200
ft.
Another
problem
is
that
with
the
piecemeal
construction
of
older
mills,
many
have
sectional
roofs
of
differing
heights
requiring
that
individual
stacks
of
varying
lengths,
some
possibly
significant,
be
constructed.
The
stack
requirement
also
ignores
a
valid,
proven
and
safe
alternative
of
using
existing,
high,
sidewall
exhausts
and/
or
opening
windows
high
up
in
the
mills
to
allow
aeration.
Why
build
stacks
when
an
existing
tried
and
proven
method
exists?
As
to
limiting
aeration
for
any
reason,
rice
mills
assume
huge
losses
when
the
mills
are
closed.
Forcing
them
to
stay
closed
another
day
so
that
aeration
can
occur
in
daylight
is
prohibitively
costly
and
unnecessary.
Consistent
air
monitoring
will
ensure
the
safety
of
those
involved
or
nearby
even
with
using
sidewall
exhausts
on
the
upper
levels
of
the
mills.
See
response
#
68.

70
NRDC
Stacks.
EPA
believes
that
equipping
enclosures
or
structures
with
vertical
stacks
will
reduce
the
necessary
size
of
buffer
zones,
and
suggests
that
this
method
may
be
preferable
in
areas
where
a
larger
buffer
zone
is
not
feasible.
NRDC
does
not
consider
the
use
of
stacks
to
disperse
MBr
emissions
to
be
a
valid
mitigation
approach.
Even
if
tall
stacks
would
reduce
risk
to
bystanders,
it
would
not
reduce
the
amount
of
MBr
used,
and
therefore
would
not
mitigate
impacts
to
the
ozone
layer.
Further,
Congress
long
ago
banned
the
use
of
tall
stacks
to
disperse
pollution
in
place
of
controlling
it.
See
Sec.
122
of
the
Clean
Air
Act,
42
U.
S.
C.
§
7423.
Although
this
provision
is
specific
to
electric
power
plants,
the
policy
of
the
law
is
clear
that
pollution
dispersion
is
not
an
acceptable
approach.
The
Agency
agrees
that
where
feasible
safer
alternatives
are
a
preferred
approached
to
using
engineering
controls
such
as
stacks.
However,
the
use
of
engineering
controls
is
an
effective
mitigation
option
for
reducing
direct
exposure
to
MeBr.

See
response
#
14
for
additional
comments
regarding
reducing
the
total
MeBr
emitted.
71
FS&
S
Risk
Management
Option
3
 
Stacks:
When
reviewing
this
issue
it
is
important
to
understand
that
50%
to
80%
[
Average]
of
the
methyl
bromide
is
commonly
lost
during
the
treatment
period.
The
Agency
considered
this
phenomenon
through
the
retention
and
emission
rate
factors
described
in
Section
6.1.1.1
in
the
risk
assessment.
Mass
loss
rates
from
1
to
100
percent
were
considered
in
the
analysis
which
encompass
those
described
in
the
comment.
72
NAMA
Exhaust
stacks
vented
vertically
to
the
outside
air
We
oppose
such
a
requirement.
Grain
mills
may
not
have
vertically
vented
exhaust
stacks.
Yet
they
can
be
aerated
in
a
safe
manner.
Mills
may
be
8
or
more
stories
high.
Side
venting
exhaust
and
simply
opening
the
windows
on
upper
floors
can
be
safe
aeration
points.
Requiring
the
retrofitting
of
air
handling
systems
coupled
with
the
installation
of
exhaust
stacks
on
the
roof
would
not
add
measurably
to
safe
aeration,
and
the
costs
would
be
substantial.
In
its
assessment
the
Agency
used
vertical
exhaust
orientations
for
modeling
purposes
because
that
is
the
only
output
orientation
that
current
models
have
the
capability
to
address.
The
Agency
acknowledges
that
side
venting
is
a
common
practice
given
the
appropriate
situations
or
nature
of
the
treated
structures.
It
does
not,
however,
have
the
modeling
capability
to
better
address
this
scenario.
As
such,
it
based
its
risk
18
#
ID
Public
Comment
Agency
Response
management
decisions
on
the
scenarios
that
best
fit
various
cultural
practices.
73
MBIP
California
regulations
define
a
"
standard
height"
exhaust
stack
as
one
which
is:
a)
at
least
10
feet
above
the
enclosure's
highest
point;
b)
at
least
10
feet
above
any
major
obstruction
within
200
feet
of
the
stack,
and
c)
at
a
certain
prescribed
height
(
above
ground
level)
calculated
from
certain
values
set
forth
elsewhere
in
the
regulations.
Many
food
manufacturing
sites
have
buildings
designed
with
multiple
stories,
some
up
to
10
or
11
stories
high,
with
exhausts
exiting
out
the
side
of
the
facility.
These
exhausts
may
be
over
100
feet
in
the
air,
but
they
would
not
meet
the
vertical
venting
requirements
of
the
California
regulations.
Replacing
exhaust
systems
would
be
extremely
expensive
and
burdensome
for
these
facilities.
As
noted
above,
potential
exposure
to
bystanders
can
be
more
effectively
controlled
and
regulated
by
imposing
air
monitoring
requirements.
If
actual
air
monitoring
demonstrates
levels
that
are
below
levels
of
exposure
concern,
the
stack
height
and
position
is
irrelevant.
In
short,
stack
height
requirements
do
not
contribute
to
increased
safety.
Facilities
should
not
be
required
to
retrofit
their
stacks
and
incur
additional
costs
to
deal
with
potential
concerns
that
are
better
addressed
by
more
flexible
and
feasible
monitoring
requirements.
See
response
#
40.

74
MBIP
EPA
has
shown
that
the
use
of
vertical
stacks
can
significantly
reduce
the
methyl
bromide
levels
in
areas
surrounding
fumigated
facilities.
For
some
facilities,
particularly
fixed
fumigation
locations,
the
use
of
stacks
may
offer
a
viable
option
to
mitigate
exposures.
However,
this
option
may
not
be
feasible
or
necessary
for
certain
types
of
facilities.
See
comments
of
North
American
Millers'
Association
regarding
vertically
vented
stacks
for
grain
mills.
If
anything,
this
option
should
be
available
to
fumigators
and
facility
operators
to
reduce
methyl
bromide
levels
if
monitoring
demonstrates
concentrations
in
excess
of
targets.
See
response
#
72.

75
APHIS
Data
from
the
Methyl
Bromide
Human
Health
Effects
Document
do
not
always
support
the
above
statement,
and,
in
fact,
indicate
that
some
types
of
fumigation
operations
that
aerate
at
ground­
level
do
not
require
a
buffer.
Nearly
all
fumigation
conducted
under
APHIS
supervision
under
normal
atmospheric
pressure
are
aerated
at
ground
level
(
small
vacuum
chambers,
usually
less
than
1,000
cubic
feet,
are
usually
aerated
through
a
stack.)
Currently,
only
two
warehouses
that
fumigate
at
normal
atmospheric
pressure
contain
permanent
stacks
for
aeration;
the
stacks
at
one
of
those
warehouses
are
currently
inoperable
and
are
not
being
used.
The
Agency
agrees
that
in
some
cases
ground
level
aeration
results
in
smaller
buffers
compared
to
using
certain
stack
scenarios.
The
Agency
has
modeled
a
wide
range
of
scenarios
that
include
ground
level
aeration
(
e.
g.
PPQ
method).

76
APHIS
Fumigation
warehouses,
like
the
one
the
EPA
visited
with
APHIS
in
Baltimore,
are
the
property
of
the
Port
Authority,
not
of
the
fumigation
company.
Therefore,
the
costs
of
any
regulations
requiring
changes
to
permanent
structures
are
borne
by
the
Port
Authority.
Buildings
located
on
Port
Authority
property
are
expensive
and
exist
at
a
premium.
If
the
Port
Authority
decides
not
to
put
resources
into
building
permanent
stacks
within
their
warehouses,
fumigation
at
the
warehouses
(
and
possibly
that
site)
may
cease;
local,
national
and
global
economic
effects
may
arise
as
a
consequence.
If
the
Port
Authority
complies
and
passes
the
costs
along
to
the
fumigator,
it
is
possible
that
it
may
no
longer
be
economical
to
fumigate
if
the
fumigator
cannot
pass
the
costs
on
to
the
importers.
The
Port
Authorities,
along
with
the
Department
of
Homeland
Security's
Custom
and
Border
Protection,
are
increasingly
taking
over
warehouses
once
used
for
fumigation
and
diverting
their
uses
to
other
purposes;
consequently,
fumigations
formerly
conducted
in
warehouse
buildings
are
progressively
becoming
redirected
to
temporary
outdoor
structures,
often
built
right
on
the
tarmac.
These
structures,
which
aerate
at
ground
level
and
operate
under
APHIS
PPQ
certification,
are
not
able
to
have
permanent
stacks;
it
is
not
known
whether
mobile
stacks
may
be
used
at
this
point
in
time.
It
is
APHIS's
understanding
that
all
fumigators
in
California
operate
using
mobile
stacks;
however,
these
mobile
units
aerate
from
enclosures
built
within
permanent
warehouses
or
from
containers
directly,
but
not
from
temporary
outdoor
structures.
It
is
not
known
whether
these
mobile
units
could
be
accommodated
to
fit
nonpermanent
structure
situations
used
at
other
ports,
where
temporary
enclosures
are
built
outdoors
and
then
sealed
with
a
tarp.
See
response
#
5.

The
Agency
also
acknowledges
that
the
specific
risk
mitigation
options
that
are
being
considered
would
likely
have
a
different
economic
effect
on
each
facility
that
conducts
fumigations.
Further,
the
Agency
agrees
that,
depending
on
the
particular
risk
mitigation
option
selected
and
the
site­
specific
conditions
of
the
facility,
some
options
could
produce
substantial
adverse
economic
effects.

77
Royal
Enclosure
Performance
Criteria.
Royal
has
always
believed
that
it
is
possible
to
make
most
fumigation
structures
more
air
tight,
and
it
has
engaged
in
research
and
development
throughout
its
existence
to
improve
tarpaulin
fumigation
procedures
and
equipment.
With
respect
to
structure
fumigation,
careful
sealing
prior
to
fumigation
is
or
should
be
an
industry
standard
practice.
The
costs
associated
with
sealing
are
primarily
the
sealing
materials,
training
and
the
cost
of
the
labor.
Since
each
building
is
unique
it
is
not
possible
to
make
general
estimates
of
cost.
With
respect
to
tarpaulin
fumigation,
on
just
one
improvement
Royal
invested
at
least
three
years'
effort
and
many
thousands
of
dollars
to
develop
a
fumigation
seal
for
which
it
is
seeking
patent
protection.
(
Royal's
seal
replaces
the
sleeves
filled
See
response
#
5.
19
#
ID
Public
Comment
Agency
Response
with
sand
("
sand
snakes")
that
are
used
to
seal
the
tarp
to
the
floor.)
It
should
be
noted
that
even
the
new
seal
is
not
applicable
to
all
of
Royal's
tarpaulin
fumigations.
Each
improvement
entails
costs
for
developing
and
testing,
adapting
the
improvement
to
existing
equipment
or
practices
or
changing
equipment
and
practices
to
allow
use
of
the
improvement,
and
obtaining
approval
from
regulators.
Overall
estimates
of
cost
are
very
difficult
but
can
range
from
tens
to
hundreds
of
thousands
of
dollars
to
take
an
idea
to
the
point
of
being
able
to
use
it.
The
costs
of
installation,
maintenance
and
use
cannot
be
generalized,
as
they
are
determined
by
the
particular
aspects
of
the
improvement,
where
it
is
used,
on
what
type
of
fumigation,
etc.
78
USA
Rice
Sealing
procedures
are
constantly
improving,
however
with
rice
mills,
some
of
which
started
construction
in
the
early
1900'
s,
and
which
are
built
using
a
variety
of
materials
spanning
that
timeframe,
appropriate
sealing
is
not
always
practicable.
As
older
construction
materials
are
replaced
with
newer,
tighter
materials
and
gas
escape
routes
are
permanently
sealed
then
fumigation
sealing
will
achieve
better
results.
Most
mills
and
fumigators
now
spend
considerable
resources
for
the
best
sealing
practices
possible
in
order
to
reduce
costs
on
the
gas.
See
response
#
5.

79
Western
Sealing
is
an
important
part
of
any
fumigation
operation
and
for
the
preservation
of
required
gas
concentrations
under
an
enclosure
or
within
a
structure.
Currently,
economics
dictates
the
minimal
use
of
methyl
bromide,
which
will
yield
the
proper
results.
Applicators
are
all
moving
towards
improved
sealing
material
and
techniques
that
are
less
expensive
than
merely
adding
more
fumigation
to
make
up
for
losses.
While
sealing
is
a
proper
concern
it
should
not
be
overly
regulated
adding
unnecessary
cost
to
an
operation,
particularly
from
a
manpower
perspective.
See
response
#
5.

80
NRDC
Enclosure
performance
criteria.
EPA
is
soliciting
information
on
whether
the
use
fumigation
structures
that
are
more
air­
tight
would
be
effective
in
reducing
the
use
and
duration
of
aeration
and
buffer
size
(
0133).
There
is
no
discussion
in
the
EPA
document
of
the
estimated
costs
or
quantitative
mitigation
impact
of
this
measure
on
the
overall
reduction
of
volume
of
MBr
used.
Has
EPA
estimated
the
impact
of
this
proposal
on
MBr
use
and
release?
Does
EPA
have
data
supporting
its
estimated
impact?
If
so,
what
is
the
source
of
this
data,
and
what
are
the
costs
associated
with
this
proposal
compared
with
the
estimated
impact
on
MBr
total
usage?
Agency
solicited
and
received
comments
for
these
the
following
questions
as
they
relate
to
enclosure
performance
criteria:
°
What
is
the
feasibility
of
implementing
this
option
on
a
national
level?
°
What
are
the
costs
associated
with
this
option?
°
How
effectively
does
this
option
mitigate
the
risks
resulting
from
methyl
bromide
use?
81
PFI
As
to
sealing
of
structures,
PFI
members
rely
on
the
counsel
provided
by
applicators
on
the
appropriate
sealing
of
structures.
Before,
during
and
after
fumigations,
PFI
member
facilities
are
constantly
monitored
to
make
sure
they
are
as
gas
tight
as
practical.
This
reduces
the
amount
of
methyl
bromide
that
is
required
is
more
cost
effective.
The
Agency
acknowledges
receipt
of
this
comment.

82
FS&
S
Risk
Management
Option
4
 
Enclosure
Performance
Criteria
This
will
vary
greatly.
I
believe
a
better
way
to
manage
this
issue
is
to
require
continued
gas
tightness
improvement.
For
space
fumigations
this
could
be
a
target
of
a
24
hour
half
loss.
This
would
be
a
very
good
space
fumigation
if
you
are
treating
a
mill,
food
plant
or
warehouse.
For
commodity
storages
and
tarps
which
do
not
have
windows,
doors,
vents
and
other
structural
challenges
the
half
loss
expectancy
should
be
much
higher.
Responsible
fumigators
have
always
pushed
to
improve
fumigation
performance
but
many
do
not.
Profume;
a
methyl
bromide
alternative
does
this
very
effectively
with
a
computer
program
called
Fumiguide.
The
Agency
acknowledges
this
comment
and
applauds
the
use
of
more
sophisticated
treatment
calculators
(
e.
g.,
Fumiguide).

83
NAMA
Sealing
structures
prior
to
fumigation
The
proper
sealing
of
structures
is
a
critical
step
for
an
effective
fumigation.
Perhaps
unforeseen
technological
advances
in
sealing
materials
may
improve
the
effectiveness
of
sealing.
Currently,
however,
we
believe
millers
and
fumigant
applicators
are
doing
an
effective
job
of
sealing
structures.
Spiraling
fumigant
costs
are
motivation
to
continue
these
efforts.
See
response
#
81.

84
MBIP
In
the
interest
of
greater
safety
and
due
to
the
high
cost
of
fumigants,
extensive
efforts
already
have
been
implemented
to
improve
sealing
and
reduce
the
amount
of
fumigant
used.
Many
plants
have
permanently
sealed
areas
of
potential
leakage.
For
example,
exterior
glass
windows
have
been
removed
and
permanently
sealed
shut.
In
addition,
many
fumigators
are
using
Virtually
Impermeable
Film
(
VIF)
or
high
density
poly
to
further
reduce
leakage.
In
general,
permanently
installed
fumigation
facilities
have
more
options
for
improved
sealing
than
food
processing
facilities.
Label
language
could
require
the
use
of
VIF
for
sealing
and
could
require
fumigators
to
demonstrate,
by
monitoring,
the
half
loss
rate
during
fumigation.
See
response
#
5.

85
APHIS
APHIS
agrees
that
enclosure
performance
criteria
are
essential
to
protect
the
health
and
safety
of
all
workers
located
at
fumigation
facilities;
however,
it
does
not
seem
likely
that
criteria
specified
by
EPA
for
their
current
risk
mitigation
document
See
response
#
5.
20
#
ID
Public
Comment
Agency
Response
would
be
adequate
to
reflect
technological
changes
as
they
occur
over
time.
APHIS
PPQ
modifies
its
fumigation
policies
by
making
frequent
edits
to
the
Treatment
Manual
to
reflect
improvements
in
fumigation
technology.
Since
EPA
modifications
to
such
performance
criteria
may
not
be
as
timely,
APHIS
recommends
that
EPA
consider
ambient
air
concentrations
as
a
sole
performance
criterion;
that
way,
the
fumigators
are
left
to
use
their
own
creative
devices
to
perform
their
duties
in
the
most
cost­
effective
manner
while
conducting
their
operations
under
a
safe
air
concentration
limit.
Currently,
APHIS
PPQ
enclosure
performance
criteria
including
the
tightness
of
the
permanent
and
temporary
enclosures,
the
size
of
the
aeration
fans,
and
the
minimum
required
temperatures,
are
part
of
APHIS
PPQ
policy
for
fumigating
imported
commodities
treated
under
APHIS
supervision
(
see
Chapters
2­
4
in
the
PPQ
Treatment
Manual
at
http://
www.
aphis.
usda.
gov/
ppq/
manuals/
port/
Treatment_
Chapters.
htm).
While
it
is
currently
possible
to
require
tighter
structures,
for
example
by
requiring
all
fumigations
to
occur
in
a
permanent
chamber,
the
costs
involved
with
doing
this
would
make
fumigation
impractical
from
a
cost/
benefit
standpoint.
If
fumigation
chambers
became
a
regulatory
requirement,
some
countries
may
consider
the
resultant
higher
costs
of
imported
commodities
to
be
a
trade
barrier;
this
may
cause
foreign
governments
to
take
more
restrictive
actions
on
our
nation's
exported
products.
Regarding
tarps:
Tarp
technology,
as
well
as
the
method
by
which
tarps
are
held
to
the
ground
has
improved
over
time.
Requiring
a
minimum
performance
for
tarps
and
sealing
may
encourage
users
to
stay
at
that
level
instead
of
switching
to
more
costly
improved
varieties
as
they
are
developed.
APHIS
PPQ
handles
leaks
by
inspecting
the
enclosure
with
a
halide
detector
once
the
gas
has
been
introduced
to
ensure
that
no
gas
is
escaping
(
self­
contained
breathing
apparatus
must
be
used).
If
gas
is
detected,
the
leak
is
found
and
repaired
immediately.
If
the
leak
cannot
be
repaired,
the
fumigation
is
aborted.
Leaks
may
also
be
deduced
and
addressed
if
the
concentration
readings
within
the
enclosure
at
the
half­
hour
point
following
gas
introduction
are
not
at
the
level
specified
in
the
Treatment
Manual
(
timed
concentration
readings
within
the
enclosure
are
mandated
by
APHIS
PPQ).
APHIS
PPQ
also
requires
that
the
tarps
be
changed
after
a
number
of
uses,
that
the
tarp
be
examined
for
holes
and
cracks
prior
to
use,
that
the
flooring
be
scrutinized
for
fumigation
appropriateness
prior
to
the
building
of
the
enclosure.
Regarding
air­
tight
enclosures:
APHIS
PPQ
does
own
and
operate
air­
tight
chambers
to
fumigate
small
lots
of
imported
propagative
plants
(
1,000
cubic
feet
or
less).
Currently,
APHIS
PPQ
is
planning
to
build
a
new
chamber
facility
which
would
hold
a
mere
four
pallets
of
commodities
(
less
than
a
single
container)
in
Miami.
The
cost
for
the
chamber,
including
the
necessary
heating
equipment,
detectors,
and
sensors,
is
estimated
to
be
around
$
400,000.
Maintenance
costs
(
e.
g.,
keeping
the
seals
tight)
will
exceed
$
13,000
per
year.
Such
chambers
are
not
cost­
effective
for
fumigating
large
consignments
of
imported
food
commodities.
Regarding
minimum
temperatures:
It
is
APHIS's
experience
that
it
is
difficult
and
expensive
to
raise
the
temperatures
to
the
minimum
required
for
fumigation
in
the
major
northern
fumigation
warehouses
during
winter
months,
when
imported
fruit
arrive
from
the
southern
hemisphere.
In
addition,
fumigation
of
perishable
commodities
at
higher
temperatures
may
cause
more
commodity
damage
than
if
the
commodity
is
fumigated
at
lower
temperatures.
Requiring
higher
minimum
temperatures
may
serve
to
create
more
of
an
economic
effect,
by
moving
fumigation
businesses,
and
the
associated
regional
economies
that
develop
from
them,
out
of
the
northern
regions
of
this
nation.
APHIS
also
notes
that
many
temperature/
treatment
regimes
are
a
result
of
international
agreements;
modifying
internationally­
accepted
temperature
regimes
without
providing
scientific
justification
(
on
efficacy)
may
put
our
country
in
an
awkward
trade
situation.
86
VR
Presented
is
a
comprehensive
overview
showing
Value
Recovery's
approach
to
irreversibly
destroying
methyl
bromide
from
fumigation
ventilation
streams
for
Q/
PS,
and
Structural
fumigations.
Methyl
bromide
belongs
to
a
larger
class
of
chemicals
known
as
alkyl
halides
that
readily
undergo
nucleophillic
substitution
reactions.
Value
Recovery
exploited
this
fundamental
feature
in
methyl
bromide's
structure
to
use
it
as
a
strategy
to
destroy
it
chemically.
In
order
for
this
process
to
gain
wide
acceptance,
removing
methyl
bromide
from
ventilation
streams
should
have
minimal
influence
on
existing
operations.
Our
solution
to
the
emissions
reduction
problem
has
only
one
moving
part,
a
blower
fan,
and
all
process
other
equipment
is
made
of
plastic,
namely
PVC,
polyethylene
and
polypropylene.
The
blower
fan
has
a
Teflon
coating.
The
cost
of
this
process
are
estimated
to
be
below
5%
of
the
fumigation
cost
for
quarantine
and
structural
fumigations
based
on
commercial
trials
and
industry
data.
(
please
note:
additional
cost
analysis
was
provided
by
this
commentor)
See
response
#
5.
21
#
ID
Public
Comment
Agency
Response
87
Royal
Recovery/
Destruction
Systems.
Royal
has
been
involved
in
development
and/
or
testing
of
three
systems
for
the
capture
and
destruction
of
methyl
bromide:
1)
its
capture
on
charcoal
and
subsequent
incineration
of
the
charcoal
(
the
Incineration
Method");
2)
capture
on
charcoal
followed
by
washing
the
charcoal
to
release
the
bromine
into
a
liquid
and
drying
of
the
charcoal
for
reuse
(
the
"
Washing
Method");
and
3)
bubbling
the
stream
of
air
and
methyl
bromide
through
a
solution
that
instantaneously
destroys
the
methyl
bromide
(
the
"
Instantaneous
Destruction
Method").
All
three
systems
successfully
capture
or
destroy
methyl
bromide
in
a
laboratory
setting.
None,
at
present,
is
capable
of
scaling
up
to
the
extent
needed
by
Royal
for
use
in
its
large
tarpaulin
fumigations
of
quarantine
fruit
that
can
total
3,000
lbs.
of
methyl
bromide
use
in
24
hours.
The
Incineration
Method
was
tested
by
several
fumigation
companies,
including
Royal.
Royal
successfully
captured
more
than
90%
of
the
methyl
bromide
in
its
test,
but
was
not
involved
after
that
step
in
the
process.
It
is
Royal's
understanding
that
incineration
of
the
charcoal
can
be
accomplished
only
at
very
high
temperatures
and
that
few
incinerators
exist
in
the
U.
S.
for
this
purpose.
Royal
estimated
that
it
would
take
railcars
full
of
charcoal
to
capture
the
methyl
bromide
used
in
its
quarantine
fruit
fumigations,
and
therefore
a
significant
cost
of
the
process
could
be
in
transportation
of
the
spent
charcoal.
The
Washing
Method
is
used
for
container
fumigations
in
other
parts
of
the
world.
Its
use
involves
purchase
of
an
engineered
door
that
is
moved
into
the
position
of
one
of
the
container
doors
and
through
which
the
methyl
bromide
is
extracted
for
capture
on
charcoal,
plus
washing
equipment.
Royal
is
working
with
the
Australian
manufacturer
of
the
system,
Nordiko,
to
adapt
the
door
to
the
containers
most
commonly
used
in
the
U.
S.
Royal
does
not
yet
know
the
costs
to
purchase
or
use
the
Washing
Method,
but
expects
that
the
washing
equipment
could
be
set
up
to
serve
a
number
of
doors
(
and
containers)
so
as
to
handle
approximately
100
lbs.
of
methyl
bromide
per
cycle.
A
significant
cost
of
use
may
be
that
of
disposal
of
the
washing
liquid,
which
may
or
may
not
be
permitted
in
certain
public
water
treatment
facilities,
or
permitted
only
at
a
cost.
Royal
does
not
believe
that
this
method
can
be
scaled
up
for
use
in
large
quarantine
fumigations
of
fruit.
The
Instantaneous
Destruction
Method
has
progressed
beyond
the
laboratory
setting
but
Royal
is
not
aware
of
its
regular
use
by
any
fumigator,
and
believes
it
may
also
have
potential
waste
disposal
problems.
Royal
has
concluded
that
eventual
use
would
probably
also
be
for
a
group
of
containers
and
not
for
large­
scale
fumigation.
See
response
#
5.

88
NRDC
Recovery/
Destruction
System.
EPA
proposes
that
a
system
that
recovered
the
excess
gas
or
converted
it
into
an
inert
material
would
reduce
or
eliminate
the
need
for
buffer
zones
and
reduce
skin
cancer
risks
associated
with
ozone
depletion
(
0133).
There
is
no
discussion
in
the
EPA
document
of
the
quantitative
mitigation
impact
of
this
measure
on
bystander
exposures
or
the
overall
reduction
of
volume
of
MBr
used.
Has
EPA
estimated
the
impact
of
this
proposal
on
MBr
use
and
release?
Does
EPA
have
data
supporting
its
estimated
impact?
If
so,
what
is
the
source
of
this
data,
and
what
are
the
costs
associated
with
this
proposal,
and
how
would
those
costs
affect
the
attractiveness
of
alternative
pest
control
methods?
Agency
solicited
and
received
comments
for
these
the
following
questions
as
they
relate
to
Recovery/
Destruction
Systems:
°
What
is
the
feasibility
of
implementing
this
option
on
a
national
level?
°
What
are
the
costs
associated
with
this
option?
°
How
effectively
does
this
option
mitigate
the
risks
resulting
from
methyl
bromide
use?
89
FS&
S
Risk
Management
Option
5
 
Recovery
/
Destruction
Systems
We
have
seen
and
worked
with
a
company
who
is
currently
destroying
methyl
bromide
used
on
QPS
containers
treated
with
methyl
bromide.
These
containers
average
3,000
cubic
feet
and
this
system
is
currently
91%
efficient.
Costs
range
$
50
per
container
to
implement
this
process.
There
are
no
incentives
to
drive
this
technology.
We
believe
we
could
improve
this
process
and
are
currently
evaluating
new
options.
See
response
#
5.

90
MBIP
The
necessary
technology
for
methyl
bromide
recovery
and
destruction
using
carbon­
based
systems
has
been
demonstrated
at
several
small
fumigation
facilities.
In
general,
for
a
facility
with
a
fumigated
volume
of
10,000
ft3
or
less,
the
system
cost
is
$
100,000
­
$
250,000,
depending
on
the
specific
installation.
The
main
operational
cost
is
regeneration
of
the
carbon,
which
adds
the
equivalent
of
about
$
15/
lb
to
the
cost
of
methyl
bromide.
While
recovery
systems
for
larger
facilities
are
technically
possible,
the
cost
of
the
initial
installation
and
the
cost
of
the
carbon
regeneration
may
be
prohibitive.
For
example,
a
system
designed
for
a
250,000
ft3
fumigation
facility
would
have
an
initial
cost
of
up
to
$
1,000,000.
If
the
facility
uses
30,000
pounds
of
methyl
bromide
per
year,
increased
operating
costs
would
be
near
$
500,000.
This
could
pose
a
significant
economic
burden.
See
response
#
5.

91
APHIS
Methyl
bromide
recovery
systems
are
still
in
the
infancy
stage;
only
one
fumigation
facility
which
recovers
methyl
bromide
has
passed
APHIS
certification
requirements.
This
unit
can
hold
no
more
than
a
single
container
(
around
2700
cubic
feet).
This
technology
not
cost
effective
for
large
scale
fumigations
needed
See
response
#
5.
22
#
ID
Public
Comment
Agency
Response
for
southern
hemisphere
perishable
commodities
such
as
Chilean
grapes.
The
cost
to
build
a
recovery
unit
for
these
commodities,
in
terms
of
dollars
per
cubic
foot
of
fumigation
space,
would
be
prohibitive.
Even
if
cost
were
not
a
factor,
the
aeration
technology
is
not
sufficiently
developed
to
appropriately
treat
the
enormous
quantity
of
imported
food
that
enters
our
nation's
borders.
Perishable
commodities
requiring
fumigation
must
be
treated
and
moved
into
the
channels
of
commerce
quickly
in
order
to
maintain
marketability.
Current
recovery
systems,
which
force
the
air
through
charcoal
to
remove
methyl
bromide,
can
push
air
out
of
small
enclosures
at
an
adequate
rate;
however,
they
would
not
be
able
to
push
fumigant
out
of
a
50,000
to
100,000
cubic
foot
enclosure
fast
enough
to
ensure
that
perishable
commodities
retain
marketability.
Even
if
the
commodities
were
not
damaged
by
from
remaining
under
fumigation
for
too
long,
the
delay
in
aeration
would
slow
the
movement
of
perishable
commodities
into
the
channels
of
commerce,
thus
causing
additional
marketability
problems.
Should
the
fumigation
procedures
slow
down,
traffic
situations
for
both
the
shipping
and
trucking
industries
may
arise
at
the
ports;
delays
in
treating
perishable
commodities
may
cause
marketability
problems
before
they
reach
the
fumigation
chamber.
92
Royal
Limitation
of
Use
by
Amount
and
Time.
Implicit
in
this
proposal
is
an
assumption
that
lower
emissions
of
methyl
bromide
over
a
number
of
days
are
preferable
to
one
emission
event,
at
a
higher
level,
during
the
same
number
of
days.
For
Royal's
large
quarantine
fumigations
of
fruit,
however,
a
daily
limit
on
the
amount
of
methyl
bromide
used
would
result
in
greater
risk
and
more
methyl
bromide
used
than
in
a
single,
large
fumigation.
For
example,
a
large
fumigation
of
Southern
Hemisphere
fruit
can
require
3,000
lbs.
of
methyl
bromide.
If
the
California
limit
of
1,000
lbs.
is
adopted,
then
three
fumigations
must
be
performed
instead
of
one.
Despite
any
measures
to
ensure
safety,
increasing
the
number
of
fumigations
increases
the
chances
for
leaks,
exposure,
etc.
In
addition,
a
large
quarantine
fumigation
uses
less
methyl
bromide
than
several
smaller
ones.
This
is
because
the
Treatment
Manual
requires
the
same
clearance
around
the
commodity
and
between
it
and
the
enclosure
walls
regardless
of
the
size
of
the
chamber
(
for
example,
four
to
six
inches
between
pallets,
two
feet
from
the
top
and
sides
of
the
stack
of
pallets).
The
area
within
the
fumigation
chamber
that
must
be
filled
with
methyl
bromide,
yet
contains
no
commodity,
is
therefore
a
smaller
percentage
of
the
total
area
in
a
large
enclosure
than
in
a
small
one,
resulting
in
a
savings
of
methyl
bromide
in
large
fumigations.
The
costs
associated
with
multiple
fumigations
are
the
extra
labor,
methyl
bromide,
storage
and
loss
of
value
for
perishable
commodities.
See
response
#
5.

93
USA
Rice
California
also
limits
the
total
amount
of
methyl
bromide
per
work
site
to
1000
pounds
in
a
24­
hour
period.
In
that
state,
if
the
total
amount
of
methyl
bromide
used
in
any
24­
hour
period
exceeds
1,000
pounds,
or
the
treated
volume
exceeds
250,000
ft3,
both
the
County
Agricultural
Commissioner
and
the
California
Department
of
Pesticide
Regulations
must
evaluate
the
request
in
order
to
grant
alternate
conditions
or
mitigation
measures.
Some
rice
mills
are
in
excess
of
1,000,000
ft3
and
alternate
conditions,
such
as
lowering
the
total
amount
of
methyl
bromide
used
in
a
24­
hour
period,
will
not
be
workable
because
it
would
lower
the
amount
of
MeBr
used
to
such
low
levels
as
to
be
ineffective
and
possibly
harmful
by
contributing
to
insect
resistance.
It
would
also
create
the
need
for
more
treatments
to
cover
large
facilities
thus
creating
more
downtime
and
more
risk
for
exposure
due
to
the
multiple
jobs.
See
response
#
5.

94
Western
Limiting
the
amount
of
methyl
bromide
that
can
be
used
at
a
particular
fumigation
site
during
a
given
period
would
be
a
severe
hardship
on
the
movement
of
perishable
commodities
through
many
of
the
major
ports
in
the
United
States.
During
the
winter
months
and
beyond,
large
shipments
of
perishables
arrive
and
must
move
as
quickly
as
possible
to
retailers
or
storage
warehouses
to
preserve
quality.
The
vessel
arrivals
are
not
precise
due
to
the
vagarious
nature
of
shipping
operations,
often
leading
to
the
discharge
of
large
volumes
of
perishables
in
any
given
period.
Currently,
volumes
of
perishables
fumigated
at
any
given
site
at
many
major
ports
are
restricted
by
time
limits
established
by
USDA
and
time
required
to
satisfy
aeration
prior
to
the
release
of
the
cargo.
In
other
words,
for
imported
commodities,
the
amount
of
fumigant
used
at
a
particular
site
in
any
given
time
period
is
already
restricted
by
these
constraints.
See
response
#
5.

95
NRDC
Limitation
of
use
by
amount
and
time.
EPA
proposes
to
limit
the
volume
and
time
of
fumigation
to
reduce
overall
use
(
0133).
NRDC
is
supportive
of
any
measures
that
severely
and
significantly
limit
or
cancel
MBr
uses.
However,
there
is
no
discussion
in
the
EPA
document
of
the
limits
that
EPA
proposes,
for
what
uses,
under
what
conditions,
by
how
much.
There
is
no
discussion
of
estimated
costs
or
quantitative
mitigation
impact
of
this
measure
on
the
overall
reduction
of
volume
of
MBr
used.
Has
EPA
estimated
the
impact
of
this
proposal
on
MBr
use
and
Agency
solicited
and
received
comments
for
these
the
following
questions
as
they
relate
to
this
option:
°
What
is
the
feasibility
of
implementing
this
option
on
a
national
level?
°
What
are
the
costs
associated
with
this
option?
23
#
ID
Public
Comment
Agency
Response
release?
Does
EPA
have
data
supporting
its
estimated
impact?
If
so,
what
is
the
source
of
this
data,
and
what
are
the
costs
associated
with
this
proposal
and
how
would
those
costs
affect
the
attractiveness
of
alternative
pest
control
methods?
°
How
effectively
does
this
option
mitigate
the
risks
resulting
from
methyl
bromide
use?
96
FS&
S
Risk
Management
Option
6
 
Limitations
of
Use
by
Amount
and
Time.
For
structures
1,000
pounds
and
25,000
cubic
feet
would
not
be
realistic.
Average
mill
volume
is
500,000
cubic
feet
and
the
average
food
processing
plant
is
1,500,000
cubic
feet.
I
would
direct
my
comments
from
RMO
Option
4
as
a
more
suitable
limitation.
See
response
#
5.

97
NAMA
Restricting
the
quantities
of
methyl
bromide
used
per
fumigation
We
oppose
the
arbitrary
restrictions
on
the
quantities
of
methyl
bromide
used
at
each
fumigation.
As
stated
earlier,
the
most
attractive
trait
of
methyl
bromide
is
its
ability
to
achieve
total
control
of
pests
in
the
food
production
facility.
If
complete,
or
as
nearly
complete
as
practical,
control
is
not
achieved,
additional
or
more
frequent
applications
of
methyl
bromide
or
other
pesticides
are
required
and
total
pesticide
usage
increases,
not
decreases
as
should
be
the
goal.
Simply
put,
the
quantity
of
methyl
bromide
(
or
any
other
pesticide)
used
should
be
the
amount
that
will
do
the
job
correctly.
Pest
management
experts,
entomologists
and
others
agree
that
further
reductions
in
the
pounds
used
per
fumigation
may
cause
other
unintended
effects.
If
the
quantity
used
is
too
low
to
be
lethal
to
all
insects
present,
the
low
level
fumigation
will
cause
insects
to
evolve
with
resistance
to
the
fumigant,
increasing
the
demand
for
more
pesticides.
It
is
not
practical,
economically
or
technically,
to
divide
the
facility
so
as
to
fumigate
only
one
portion
of
the
mill
at
one
time
and
thereby
reduce
the
amount
of
compound
used
per
fumigation.
For
example,
consider
a
mill
of
2.0
million
cubic
feet
in
volume.
At
a
dosage
of
1.25
pounds
per
1,000
cubic
feet,
the
fumigation
would
require
2,500
pounds
of
fumigant,
not
including
so­
called
`
add
gas'
or
the
additional
fumigant
that
is
added
during
the
fumigation
to
keep
the
concentration
at
the
target
level
lethal
to
insects.
If
an
arbitrary
restriction
of,
say,
1,000
pounds
per
fumigation
were
imposed,
the
mill
would
need
to
be
fumigated
in
three
separate
events.
This
would
triple
the
downtime
and
associated
costs
and
lost
revenue.
Finally,
the
price
of
methyl
bromide
continues
to
spiral
upward.
It
is
highly
unlikely
that
any
user
of
the
compound
is
using
more
than
is
necessary
to
achieve
total
control.
See
response
#
5.

98
MBIP
When
fumigations
occur
in
California
the
total
amount
of
methyl
bromide
used
in
any
24­
hour
period
may
not
exceed
1,000
pounds.
If
more
methyl
bromide
is
required
or
the
treated
volume
exceeds
250,000
ft3,
both
the
County
Agricultural
Commissioner
and
the
California
Department
of
Pesticide
Regulations
must
evaluate
the
request
in
order
to
grant
alternate
conditions
or
mitigation
measures.
Typical
food
processing
facilities
are
in
excess
of
1,000,000
ft3.
Thus,
the
need
to
request
alternate
conditions
would
be
necessary
for
many
facilities.
The
alternate
conditions
typically
imposed
may
not
be
feasible
for
a
particular
site
and
may
make
it
impossible
for
that
site
to
complete
a
fumigation.
For
example,
one
alternate
condition
utilized
to
allow
for
fumigation
of
larger
facilities
is
to
lower
the
total
amount
of
methyl
bromide
used
in
a
24­
hour
period.
Application
rates
as
low
as
5
oz/
1,000
ft3
in
combination
with
carbon
dioxide
(
CO2)
would
be
necessary
at
some
sites
in
order
to
meet
this
requirement.
This
does
not
allow
for
any
amount
of
additional
methyl
bromide
that
may
become
necessary
during
the
treatment
to
ensure
a
lethal
dose
against
the
targeted
pest.
A
major
concern
with
utilizing
methyl
bromide
at
such
a
low
application
rate
is
the
future
impact
this
would
have
on
insect
resistance.
California
also
specifies
the
maximum
concentration
that
can
be
present
inside
a
facility
before
aeration
can
occur.
An
example
of
a
final
permit
condition
currently
in
place
for
a
large
food
handling
facility
requires
that
not
more
than
50
pounds
of
methyl
bromide
may
be
present
inside
the
structure
before
aeration
is
started.
This
results
in
unacceptable
downtime
for
food
handling
establishments
and
could
draw
out
aeration
time
into
several
days
or
up
to
a
week.
Downtime
costs
per
day
for
a
typical
mill
or
food
handling
facility
can
easily
exceed
$
100,000.00
per
day
See
response
#
5.

99
MBIP
Limiting
the
amount
of
fumigant
that
can
be
used
in
a
given
time
period
would
encourage
fumigators
and
food
plants
to
reduce
dosage,
conduct
fewer
treatments,
or
provide
other
less
effective
options.
These
practices
already
have
resulted
in
less
effective
treatments,
the
potential
for
diminished
sanitation
at
some
of
our
nation's
food
plants,
and
can
potentially
lead
to
insect
resistance
as
is
currently
the
case
with
phosphine.
This
practice
would
pose
particular
problems
at
ports
where
incoming
perishable
commodities
must
be
treated
quickly
to
comply
with
USDA
requirements,
and
to
ensure
shelf
life
is
not
severely
impacted.
Also,
food
processing
facilities
typically
schedule
fumigations
during
weekends
or
holiday
weekends
to
minimize
See
response
#
5.
24
#
ID
Public
Comment
Agency
Response
production
disruptions.
Limitations
on
amount
and
time
could
have
severe
economic
impacts.
(
See
also
our
comments
relating
to
problematic
conditions
under
California's
system
in
Section
above.)
A
preferred
solution
would
be
to
require
monitoring
to
demonstrate
that
acceptable
levels
are
not
exceeded.
100
APHIS
Similar
concerns
which
would
arise
from
requiring
recovery
systems
for
all
fumigations
would
also
arise
from
limiting
methyl
bromide
use
by
amount
and
time.
Over
the
years,
business
infrastructures
supporting
local
and
regional
economies
have
developed
around
the
importation
of
large
quantities
of
perishable
commodities
along
a
section
of
the
northeastern
coast
of
our
country.
To
handle
certain
cargoes
such
as
Chilean
fruit,
these
regions
have
developed
specialized
infrastructures
such
as
cold
storage,
pier
space
to
fumigate
with
adequate
buffer
zones,
specially
trained
personnel
(
longshoreman,
pier
managers,
fumigators,
quality
control,
Federal
employees).
Major
cargo
transportation
routes
have
developed
around
these
infrastructures.
The
cost
would
be
prohibitive
to
develop
more
ports
in
such
a
manner.
A
single
fumigation
enclosure
in
some
warehouses
that
contain
multiple
enclosures
might
exceed
100,000
cubic
feet
at
some
of
these
northeastern
ports;
if
the
temperature
is
cold
enough,
a
single
enclosure
containing
perishable
commodities
may
contain
up
to
400
pounds
of
methyl
bromide.
During
the
winter
months,
when
perishable
commodities
enter
our
nation's
ports
from
the
southern
hemisphere,
certain
eastern
seaboard
locations
may
have
up
to
11
fumigation
operations
occurring
simultaneously
 
releasing
over
4,000
pounds
of
fumigant
in
one
evening.
If
fumigation
were
limited
in
the
manner
currently
required
by
California,
the
local,
national,
and
global
economic
infrastructure
that
has
developed
over
the
years
would
collapse.
Limiting
the
amount
and
use
of
methyl
bromide
would
seriously
impede
the
movement
of
perishable
commodities
out
of
the
ports
with
short­
term
economic
consequences
that
may
include:
loss
of
marketability
of
the
commodities
arising
from
delays
in
fumigation
and
inappropriate
storage
conditions
(
there
are
insufficient
storage
warehouses
to
hold
perishables
if
they
cannot
be
fumigated
immediately
after
being
off­
loaded
from
vessels);
increased
vessel
traffic
with
potential
increases
in
accidents;
and
increased
truck
traffic
with
potential
increases
in
accidents.
Back­
ups
of
vessels
containing
imported
fruit
may
begin
to
occur
at
the
exporting
country.
Countries
may
export
less
to
our
country
to
avoid
losses
at
the
ports.
From
a
global
trade
perspective,
complaints
to
the
United
States
by
exporting
countries
stand
to
increase
significantly.
In
the
long­
term,
it
is
possible
that
new
fumigation
facilities
and
warehouses
might
develop
to
handle
the
treatments
for
those
quantities
of
shipments
that
could
not
be
treated
at
the
standard
ports
of
entry.
However,
this
would
mean
that
untreated
cargo
would
be
moving
inland
from
the
ports.
APHIS
has
serious
phytosanitary
concerns
regarding
this
scenario.
Moving
imported
commodities
within
our
nation's
borders
prior
to
treatment,
even
with
safeguarding
measures
in
place,
may
increase
the
risk
of
a
non­
indigenous,
quarantine
pest
escaping
into
the
environment.
The
Agency
also
acknowledges
that
the
specific
risk
mitigation
options
that
are
being
considered
would
likely
have
a
different
economic
effect
on
each
facility
that
conducts
fumigations.
Further,
the
Agency
agrees
that,
depending
on
the
particular
risk
mitigation
option
selected
and
the
site­
specific
conditions
of
the
facility,
some
options
could
produce
substantial
adverse
economic
effects.

101
Royal
Timings
of
Applications
or
Aeration.
Royal
questions
whether
the
premise
underlying
this
proposal,
that
the
atmosphere
at
night
is
more
stable
than
during
the
day,
applies
to
the
port
settings
in
which
Royal
does
most
of
its
fumigations.
In
almost
twenty
years
of
water­
side
fumigation,
it
is
Royal's
experience
that
there
is
always
some
sort
of
prevailing
wind
at
night
that
can
be
used
to
help
control
the
dispersal
of
methyl
bromide
emissions.
There
can
also
be
daytime
air
inversions
that
make
it
more
difficult
to
predict
dispersion.
Under
these
circumstances
Royal
believes
that
the
safety
advantages
of
working
in
a
port
at
night,
when
other
personnel
are
not
present,
far
outweigh
any
benefit
from
less
stable
daytime
air.
See
response
to
comment
34
above.
The
Agency
would
also
welcome
the
submission
of
additional
meteorological
data
for
modeling
purposes.
It
should
also
be
noted
that
the
Agency
used
coastal
weather
sources
in
Ventura
California
for
modeling
coastal
situations.

102
ASOEX
Timing
of
Applications
or
Aeration:
It
is
questionable
if
the
atmospheric
conditions
along
the
California
coast
apply
to
other
fumigation
sites.
If
aeration
is
required
to
start
during
daylight
horns
for
all
fumigation
locations,
the
importation
process
at
ports
of
entry
on
the
East
Coast
for
Chilean
fresh
produce
would
be
adversely
affected
as
the
fumigation
and
aeration
of
Chilean
generally
take
place
during
night
hours,
when
few
people
are
likely
to
be
in
the
area
surrounding
the
fumigation,
in
a
secured
port
warehouse
and
with
the
cooperation
of
port
security
to
keep
bystanders
from
the
sites.
See
response
#
37.
The
Agency
would
also
welcome
the
submission
of
additional
meteorological
data
for
modeling
purposes
(
HED/
SRRD)

103
NRDC
Timing
of
applications
or
aeration.
EPA
notes
that
the
less
stable
atmosphere
during
the
daylight
hours
results
in
dilution
and
dissipation
of
methyl
bromide
more
rapidly
than
during
the
more
stable
night
time
conditions.
California
DPR
already
requires
that
aeration
with
MBr
be
performed
during
daylight
hours
((
Reference
Manual
 
Methyl
Bromide
Commodity
Fumigation.
August
8,
1994.
State
of
California
Environmental
Protection
Agency).
If
daytime
aerations
are
See
response
#
81.
25
#
ID
Public
Comment
Agency
Response
not
practical,
CDPR
requires
a
larger
buffer
zone
to
be
in
effect
for
nighttime
aerations.
Has
EPA
estimated
the
impact
of
this
proposal
on
overall
MBr
use
and
release?
Does
EPA
have
data
supporting
its
estimated
impact?
Has
EPA
evaluated
the
impact
of
this
restriction
on
the
attractiveness
of
alternative
pest
control
methods?
104
FS&
S
Risk
Management
Option
7
 
Timing
of
Applications
or
Aeration.
Most
space
applications
are
heavily
impacted
by
wind.
These
are
generally
24
hour
treatment
periods.
If
ventilation
starts
during
daylight
when
winds
are
normally
the
highest
 
"
add
gas"
will
subsequently
be
greater
during
the
most
critical
first
12
hours
of
the
treatment.
We
generally
practice
the
opposite
of
the
California
suggested
process
with
excellent
results.
See
response
#
37.
The
Agency
would
also
welcome
the
submission
of
additional
meteorological
data
for
modeling
purposes
(
HED/
SRRD)

105
NAMA
Limiting
aeration
to
daylight
hours
except
for
facilities
meeting
an
exhaust
stack
height
requirement
We
oppose
such
arbitrary
restrictions.
Restricting
aeration
to
daylight
hours
will
not
contribute
measurably
to
safe
usage.
In
fact,
depending
on
the
location,
it
could
conceivably
add
to
the
risk.
For
example,
for
a
mill
in
an
urban
location,
it
may
be
far
better
to
aerate
during
the
night.
Those
decisions
are
best
left
to
the
professional
fumigator
using
site­
specific
information
and
experience.
Further,
such
a
restriction
would
extend
the
time
of
the
fumigation
and
add
considerably
to
the
expense.
Mills
come
in
all
different
shapes,
sizes
and
heights.
Yet
all
can
be
safely
aerated
without
a
restriction
based
on
hours
or
height.
Actual
air
monitoring
is
the
best
way
to
ensure
the
safety
of
the
aeration
process.
See
response
#
37.
The
Agency
would
also
welcome
the
submission
of
additional
meteorological
data
for
modeling
purposes
(
HED/
SRRD)

106
MBIP
Many
facilities
and
enclosures
do
not
have
exhaust
stacks
that
meet
height
requirements
imposed
in
California.
Thus,
aeration
limitations
would
apply.
Aeration
during
daylight
hours
can
cause
disruption
in
the
operation
of
fumigated
facilities.
If
the
facility
is
not
able
to
complete
treatment
preparation
and
shutdown
at
scheduled
times,
the
aeration
time
will
be
delayed
and
may
not
fall
within
the
anticipated
time.
Thus,
aeration
hour
restrictions
can
contribute
to
longer
downtime
periods
for
the
facility.
Actual
monitoring
is
the
only
way
to
ensure
the
aeration
process
is
proceeding
safely.
Proper
monitoring
by
trained
individuals
can
assure
gas
concentrations
outside
the
fumigated
site
do
not
pose
safety
concerns
regardless
of
the
time
of
day
when
aeration
occurs.
If
air
monitoring
indicates
a
need,
the
aeration
process
can
be
slowed
down
so
that
the
level
of
methyl
bromide
remains
within
acceptable
limits.
See
response
#
5.

107
APHIS
APHIS
believes
that
it
would
be
unsafe
to
require
aeration
events
to
occur
during
hours
when
the
ports
are
full
of
people.
Active
aeration
takes
a
minimum
of
2­
3
hours;
passive
aeration,
which
often
follows
active
aeration
to
allow
for
offgassing
requires
several
more
hours.
It
has
been
APHIS's
experience
that
it
is
difficult
to
convince
port
employees,
passers­
by,
forklift
operators,
and
truck
drivers
in
busy
ports
to
stay
outside
of
the
buffer
area
for
any
length
of
time.
While
many
ports,
particularly
those
in
California
and
Florida,
treat
and
aerate
large
quantities
of
smaller
enclosures
during
daylight
hours,
most
of
these
facilities
are
located
away
from
other
port
activities.
The
ports
which
fumigate
large
enclosures,
holding
400
lbs
of
gas
or
more,
and
which
do
not
have
warehouses
located
away
from
port
activities,
time
their
fumigations
so
that
aeration
occurs
when
the
fewest
people
are
present
 
during
late
night
and
early
morning
hours.
See
response
#
37.

108
Royal
Sensitive
Sites.
Royal
believes
that
the
methyl
bromide
product
labels
already
prohibit
fumigation
and
aeration
in
areas
where
people
are
present,
including
schools,
hospitals
and
other
sensitive
sites.
Royal
is
not
aware
of
data
that
show
the
need
for
other
protective
measures
for
these
types
of
sites.
Current
EPA
labels
do
not
require
buffer
zones.
The
Agency
is
considering
whether
to
require
additional
mitigation
controls
for
sensitive
site
where
risks
may
be
higher.
109
NRDC
Sensitive
sites.
The
EPA
is
considering
additional
protective
measures
for
schools,
hospitals,
and
other
sensitive
sites,
including
a
prohibition
on
fumigations
or
aeration
while
people
are
present.
NRDC
is
supportive
of
any
measures
that
severely
and
significantly
limit
or
cancel
MBr
uses,
particularly
near
sensitive
sites.
However,
there
is
no
discussion
in
the
EPA
document
of
the
limits
that
EPA
proposes,
for
what
uses,
under
what
conditions,
by
how
much.
There
is
no
discussion
of
estimated
costs
or
quantitative
mitigation
impact
of
this
measure
on
the
overall
reduction
of
volume
of
MBr
used.
Has
EPA
estimated
the
impact
of
this
proposal
on
MBr
use
and
release
at
sensitive
sites?
Does
EPA
have
data
supporting
its
estimated
impact?
If
so,
what
is
the
source
of
this
data,
and
what
are
the
costs
associated
with
this
proposal
compared
with
the
estimated
impact
on
MBr
total
usage?
Has
EPA
evaluated
the
impact
of
this
restriction
on
the
attractiveness
of
alternative
pest
control
methods?
The
Agency
solicited
and
received
comments
for
these
the
following
questions
as
they
relate
to
sensitive
sites:
°
What
is
the
feasibility
of
implementing
this
option
on
a
national
level?
°
What
are
the
costs
associated
with
this
option?
°
How
effectively
does
this
option
mitigate
the
risks
resulting
from
methyl
bromide
use?

110
FS&
S
Risk
Management
Option
8
 
Sensitive
Sites
The
Agency
considered
these
comments
26
#
ID
Public
Comment
Agency
Response
This
sounds
prudent
but
what
is
the
distance?
As
for
not
allowing
other
people
to
be
"
on
site"
 
more
detail
is
needed.
What
is
a
"
safe"
distance?
For
a
container
vs.
a
20,000,000
cubic
foot
food
processing
facility.
It
should
recognize
volumes
of
scale.
when
evaluating
the
potential
of
establishing
additional
measures
for
sensitive
sites.

111
MBIP
EPA's
Post­
Harvest
RA
already
includes
safety
factors
that
take
into
account
the
most
sensitive
individuals
in
a
population,
so
there
is
no
rationale
for
the
Agency's
suggestion
that
additional
protection
is
needed
for
some
types
of
facilities.
Current
labels
and
work
practices
already
require
that
the
fumigated
facility
and
immediate
surrounding
area
be
cleared
of
people
(
except
the
fumigation
crew)
when
the
fumigation
is
in
progress.
See
Response
#
110.

112
APHIS
Current
APHIS
PPQ
buffers
are
protective
of
port
employees;
therefore,
APHIS
does
not
see
how
additional
protective
measures
are
needed
for
sites
located
even
farther
away.
APHIS
PPQ
guidance
exists
that
would
prevent
certification
of
a
fumigation
site
located
directly
upwind
from
a
school
or
hospital;
furthermore,
the
majority
of
sites
are
intentionally
located
in
areas
secluded
from
other
businesses.
It
appears
that
this
section
is
in
direct
conflict
with
mitigation
number
7,
which
prefers
to
have
fumigation
occur
during
daylight
hours,
when
businesses
and
schools
are
operating
and
more
people
are
present.
See
Response
#
110.

113
CDPR
Our
comments
pertain
to
Risk
Management
option
9
(
Minimum
Aeration
Times).
This
option
includes
the
statement
"
The
amount
of
air
which
passes
through
the
enclosure
or
structure
has
a
minimal
effect
on
the
rate
of
off­
gassing....
The
Agency
believes
that
a
minimum
time
period
for
aeration
may
reduce
exposures
for
workers
reentering
enclosures".
The
amount
of
air
passing
through
the
fumigation
structure
has
a
huge
effect
on
exhausting
the
methyl
bromide
that
is
ultimately
emitted
by
the
commodity.
Defining
a
minimum
aeration
period
is
a
good
idea,
but
active
ventilation
as
a
method
to
control
worker
exposure
should
not
be
neglected.
This
is
especially
important
in
storage
areas.
The
basis
for
this
option
came
directly
out
of
the
CDPR
Reference
Manual
(
page
45).

Condition
14
­
Enclosures
must
be
aerated
for
the
following
minimum
duration:
a.
4
hours
if
mechanically
ventilated
using
fans,
or
b.
12
hours
if
passively
ventilated
NOTE:
This
condition
pertains
to
aeration
of
the
fumigation
enclosure,
not
aeration
of
areas
where
commodities
are
stored,
except
when
they
are
the
same.
Reasoning
Methyl
bromide
absorbed
within
the
commodity
can
continue
to
offgas
for
a
long
time.
The
rate
of
off­
gassing
depends
on
how
tightly
methyl
bromide
binds
to
the
commodity.
The
amount
of
air
which
passes
through
the
enclosure
has
a
minimal
effect
on
the
rate
of
off­
gassing.

The
EPA
agrees
that
a
minimum
aeration
time
alone
should
not
be
relied
upon
to
reduce
exposures
for
workers
reentering
enclosures.
However,
in
accordance
with
CDPR's
manual,
EPA
believes
that
the
amount
of
air
which
passes
through
the
enclosure
or
structure
will
have
a
minimal
effect
on
the
rate
of
off­
gassing.
While
the
Agency
agrees
that
active
ventilation
is
effective
in
reducing
the
concentration
of
MeBr,
a
minimum
aeration
period
may
be
needed
to
ensure
that
off­
gassing
has
continued
to
sufficient
levels.
114
Royal
Minimum
Aeration
Times.
Royal
does
not
see
the
logic,
or
the
value,
of
a
proposal
for
minimum
aeration
times.
Simply,
if
a
fumigator
is
given
a
choice
between
entering
an
area
that
has
been
subjected
to
a
minimum
required
aeration,
or
an
area
in
which
the
level
of
methyl
bromide
has
been
demonstrated
to
be
5
ppm
or
less,
no
one
will
opt
for
a
minimum
aeration
time.
Royal
is
not
aware
of
data
that
demonstrates
that
the
5
ppm
requirement
is
inadequate,
and
further
believes
that
fumigators
and
regulators
should,
and
must,
exercise
their
judgment
in
finding
the
best
combination
of
active
and/
or
passive
aeration
to
achieve
the
5
ppm
requirement.
Current
EPA
label
specify
a
5
ppm
limit.
The
Agency
is
now
considering
a
lower
limit
based
on
HED
risk
assessment
(
see
response
#
2).
The
Agency
is
not
proposing
that
that
fumigators
choose
between
a
minimum
aeration
time
AND
the
5
ppm
limit.

115
APHIS
APHIS
believes
that
placing
minimum
aeration
times
on
the
label
may
serve
to
decrease
the
safety
of
methyl
bromide
use.
It
would
be
preferable
to
allow
users
to
have
flexibility
in
deciding
an
appropriate
aeration
time,
according
to
the
situation.
By
placing
a
minimum
aeration
time
on
the
label,
both
workers
and
by­
standers
may
be
led
into
a
false
sense
of
security
regarding
the
safety
of
re­
entering
a
fumigation
area
without
wearing
self­
contained
breathing
apparatus
following
a
required
aeration
period.
The
Agency
acknowledges
this
comment
and
considered
the
implications
of
aeration
durations
in
its
risk
management
decision.
The
Agency
would
also
encourage
the
development
of
real­
time
methyl
bromide
air
monitors
which
can
reliably
screen
for
lower
air
concentrations
27
#
ID
Public
Comment
Agency
Response
In
addition,
it
is
difficult
to
imagine
how
EPA
could
develop
minimum
standards
of
aeration
which
would
keep
up
with
the
technological
changes
in
packing
material
and
methods,
both
of
which
may
affect
treatment
and
aeration
times.
The
APHIS
PPQ
Treatment
Manual
covers
a
wide
variety
of
issues
that
may
affect
treatment
and
aeration
(
see
Chapter
2­
3
at
http://
www.
aphis.
usda.
gov/
ppq/
manuals/
port/
pdf_
files/
Treatment_
Chapters/
02­
03­
ChemFumMethyl%
20Bromide.
pdf
)
For
example,
plastic
wrappings
such
as
cellophane,
films,
and
shrink
wrap,
and
papers
that
are
waxed,
laminated,
or
waterproofed
are
not
readily
permeable.
APHIS
requires
that
they
be
removed,
opened,
or
perforated
in
a
very
specific
manner
before
fumigation
in
order
to
ensure
that
the
commodity
receives
the
fumigant;
likewise,
the
removal
of
the
fumigant
also
becomes
a
challenge.
Boxes
packed
with
wood
or
other
sorptive
material
which
off­
gas
over
time,
also
cause
aeration
to
be
a
challenge.
Great
Lakes
Chemical
Company
has
reminded
APHIS
that
air
concentration
readings
must
be
taken
within
the
box
of
fruit
itself,
not
in
the
air
space
between
the
pallets
holding
the
boxes
of
fruit;
this
greatly
increases
the
time
needed
to
remove
the
fumigant
as
it
off­
gasses
from
the
fruit
and
the
sorptive
materials
in
the
box.
In
short,
aeration
times
must
be
increased
for
commodities
packaged
in
certain
ways
to
ensure
that
the
air
concentration
levels
within
the
box
are
adequately
reduced
to
5
ppm,
the
current
allowable
level.
How
would
EPA
determine
the
appropriate
aeration
time
for
the
various
ways
commodities
are
packaged
and
wrapped?
Allowing
APHIS
(
and
fumigators)
flexibility
in
determining
necessary
aeration
times
according
to
the
readings
of
ambient
air
concentrations
will
allow
commodities
that
are
not
packaged
in
certain
ways
to
aerate
more
quickly,
and
thus
enter
the
chain
of
commerce
more
efficiently.
The
current
method
of
requiring
a
maximum
air
concentration
level
appears
to
be
the
best
and
most
reliable
way
to
maintain
safety
during
fumigation
and
aeration.
in
order
that
they
can
be
used
as
key
component
in
any
real­
time
monitoring
requirements
instituted
by
the
Agency.

With
regard
to
the
general
issue
of
aeration,
it
is
clear
that
an
approach
to
effectively
manage
the
risks
for
workers
and
others
who
might
be
impacted
from
incomplete
aeration
needs
to
be
multifaceted
including
some
sort
of
aeration
time
stipulations
and
also
a
real­
time
monitoring
component
which
would
add
flexibility
for
users.
Specific
guidance
for
monitoring
is
also
being
discussed.
The
points
raised
by
APHIS
in
this
comment
with
regard
to
monitoring
are
critical
to
the
nature
of
an
effective
program
and
were
considered
in
the
Agency's
decision.
It
is
clear,
for
example,
that
sampling
in
treated,
wrapped
commodity
packaging
is
likely
a
health
protective
approach.

The
Agency
also
acknowledges
that
developing
a
universally
applicable
approach
to
establishing
a
standard
aeration
time
would
be
difficult
because
of
the
broad
range
of
potential
field
situations
that
could
be
encountered.
Key
factors
could
be
the
nature
of
the
packaging,
volume
of
treated
space,
type
of
commodity,
and
the
nature
of
the
treatment
facility
(
e.
g.,
concrete
or
wood
construction).
116
USA
Rice
Minimum
aeration
durations
are
also
required
under
California
rules.
Waiting
as
much
as
an
extra
12
hours
adds
prohibitive
costs
to
the
fumigation
process.
USA
Rice
believes
that
air
monitoring
is
not
only
sufficient,
but
also
the
only
sure
way
to
determine
if
an
area
is
safe
to
enter
and
therefore
aeration
time
limits
should
not
be
required.
See
response
$
8.

117
ASOEX
Minimum
Aeration
Times:
The
establishment
of
a
minimum
time
period
for
aeration
would
delay
the
importation
process
of
Chilean
fresh
produce.
See
response
#
5.

118
NRDC
Minimum
aeration
times.
EPA
recognizes
that
MBr
will
off­
gas
from
products
and
commodities
that
have
been
treated.
Current
labels
require
aeration
until
concentration
reaches
5
ppm
or
less,
but
a
minimum
time
is
not
listed.
A
minimum
time
may
limit
worker
reentry
exposures.
EPA
outlines
the
results
of
air
dispersion
modeling
which
demonstrates
that
extending
aeration
intervals
(
e.
g.
from
1
hr
to
4
hrs)
is
an
effective
means
to
reduce
ambient
air
concentrations
of
MBr
(
pg
41,
Figure
11).
EPA
reports
that
that
there
is
an
inverse,
direct
correlation
between
the
length
of
the
aeration
interval,
and
the
resulting
ambient
air
concentrations
during
this
period
of
the
fumigation
operation.
If
the
aeration
interval
is
doubled,
a
50
percent
reduction
in
the
ambient
air
concentrations
during
aeration
would
be
expected.
CDPR
presently
requires
minimum
aeration
intervals
ranging
from
4
hours
to
12
hours
for
MBr
fumigations
((
Reference
Manual
 
Methyl
Bromide
Commodity
Fumigation.
August
8,
1994.
State
of
California
Environmental
Protection
Agency).
See
response
#
115.

119
FS&
S
Risk
Management
Option
9
 
Minimum
Aeration
Times
It
is
important
to
understand
that
aeration
should
not
be
rushed.
Careful
and
comprehensive
monitoring
is
required.
Having
an
aeration
plan
as
part
of
the
FMP
is
critical.
Many
temporary
ventilation
systems
are
available
and
used
today.
Fan
assisted
aeration
should
be
required
 
no
passive
ventilation
should
be
allowed.
Ventilation
should
not
be
complete
until
commodity
concentration
is
at
or
below
the
PEL.
Most
fumigation
situations
facilitate
quick
headspace
aeration
time
but
clearing
the
commodity
in
bulk
or
bag
takes
much
longer.
If
gas
is
not
cleared
from
the
dense
areas
then
safety
can
be
compromised.
See
response
#
5.

120
NAMA
Mandated
minimum
aeration
times
We
oppose
minimum
aeration
times
as
they
will
not
guarantee
safety.
Safe
reentry
can
only
be
ensured
by
air
monitoring
as
is
currently
the
case.
If
air
monitoring
shows
the
facility
is
safe
for
re­
entry,
there
is
no
cause
for
keeping
the
facility
idle
awaiting
the
expiration
of
an
arbitrary
time
period.
If
the
air
is
not
safe,
only
air
monitoring
will
detect
it
and
prevent
an
unsafe
entry.
See
response
#
115.
28
#
ID
Public
Comment
Agency
Response
121
MBIP
These
aeration
requirements
are
not
necessary
for
many
facilities.
The
best
way
to
minimize
risk
and
ensure
safe
levels
for
re­
entry
is
to
conduct
air
monitoring
during
the
fumigation.
If
air
monitoring
indicates
levels
of
methyl
bromide
below
risk
levels,
the
area
is
safe
to
re­
enter
and
additional
aeration
is
redundant
and
unnecessary.
Under
the
California
system,
the
facility
must
remain
shut
down
during
the
entire
prescribed
aeration
period
regardless
of
whether
actual
air
concentrations
are
below
acceptable
levels.
This
increases
the
downtime
for
food
handling
facilities
and
imposes
unnecessary
costs.
See
response
#
5.

122
MBIP
Current
labels
require
aeration
until
the
methyl
bromide
concentration
reaches
5
ppm
or
less.
The
Risk
Mitigation
Memo
suggests
that
a
minimum
time
period
for
aeration
might
reduce
exposures
for
workers
reentering
the
structures.
The
MBIP
sees
no
need
for
this
requirement.
If
followed,
the
current
requirement
for
monitoring
provides
adequate
protection.
If
aeration
is
continued
until
the
target
concentration
is
reached,
it
is
difficult
to
understand
how
aeration
for
a
specified
time
period
would
provide
additional
protection.
More
detailed
label
language
on
how
concentrations
are
to
be
monitored
would
be
preferable
to
a
minimum
aeration
time
requirement.
See
response
#
5.

123
Royal
Permits.
It
has
been
Royal's
experience
in
the
past
that
the
existing
regulatory
scheme
is
adequate
to
monitor
or
audit
fumigation
industry
operations.
In
certain
areas
where
Royal
operates,
the
state
authorities
maintain
lists
of
fumigation
sites
and
the
activity
there.
In
other
states,
the
regulators
make
it
their
business
to
know
the
fumigation
companies.
In
quarantine
fumigation,
of
course,
APHIS
is
on
site
during
the
fumigation.
In
all
cases,
Royal
welcomes
regulators
on
planned
or
unplanned
visits.
Local
regulators
are
familiar
with
sites,
companies,
product
labels
and
their
enforcement.
In
addition,
Royal
informs
local
emergency
services,
such
as
fire
departments,
of
all
fumigations
so
that
the
public
can
be
protected
in
the
event
of
an
emergency
at
or
near
a
fumigation
site.
We
do
not
see
how
additional
oversight
will
improve
the
situation.
Royal
has
additional
concerns
about
a
permitting
process
if
it
has
the
potential
to
delay
fumigation
operations.
In
our
operations,
Royal
responds
to
the
schedules
of
the
transportation
industry
and
we
often
fumigate
on
very
short
notice
due
to
changes
in
ship
arrival
times,
availability
of
port
labor
or
equipment,
etc.
We
have
no
problem
reporting
our
operations,
after
the
fact,
to
the
appropriate
regulators
and
assisting
them
in
trying
to
anticipate
our
schedule
so
that
they
can
check
on
us,
but
a
permitting
process
that
hinges
on
bureaucratic
action
to
proceed
will
seriously
interrupt
commerce.
See
response
#
5.

124
ASOEX
Permits:
ASOEX
believes
the
fumigators
diligently
comply
with
EPA
regulations,
USDA/
APHIS
fumigation
guidelines,
and
local
requirements.
Any
permit
program
at
Federal
level
would
create
additional
obstacles
when
a
timely
importation
process
of
perishable
commodities
is
beneficial
to
U.
S.
consumers.
See
response
#
81.

125
NRDC
Permits.
California
has
a
permitting
system
for
commodity
fumigation
based
on
a
comprehensive
state­
wide
program
that
relies
on
County
Agriculture
Commissioners
reviewing
and
issuing
permits.
The
system
helps
to
ensure
compliance
with
label
requirements
and
enforce
against
misuse.
NRDC
supports
the
permit
program
as
a
way
to
capture
use
and
compliance,
and
to
assist
with
enforcement.
However,
NRDC
does
not
believe
that
this
mitigation
proposal
will
reduce
the
overall
MBr
use
in
any
significant
way.
Does
EPA
have
data
supporting
its
estimated
impact?
If
so,
what
is
the
source
of
this
data,
and
what
are
the
costs
associated
with
this
proposal
compared
with
the
estimated
impact
on
MBr
total
usage?
Has
EPA
evaluated
the
impact
of
this
restriction
on
the
attractiveness
of
alternative
pest
control
methods?
See
response
#
81.

126
FS&
S
Risk
Management
Option
10
 
Permits
Yes
 
I
agree.
See
response
#
5.

127
MBIP
In
California,
WSP
requirements
are
feasible
because
there
is
a
regulatory
infrastructure
for
review
and
approval.
California's
program
for
regulating
pesticide
use
is
unique
because
within
each
county
there
is
a
County
Agricultural
Commissioner
that
oversees
the
application
permitting
program.
Fumigation
site
plans
are
submitted
by
the
certified
applicator
to
one
of
approximately
60
County
Agricultural
Commissioner's
offices.
After
plans
are
reviewed
and
approved,
a
final
permit
is
issued
for
the
fumigation
site
that
spells
out
specific
conditions
that
must
be
met
in
order
for
the
fumigation
to
proceed.
Commissioners
also
issue
a
Restricted
Materials
Permit
which
must
be
in
place
before
utilizing
methyl
bromide
and
complete
on­
site
inspections
of
the
fumigation.
We
are
unaware
of
any
other
States
that
have
regulatory
systems
of
this
magnitude.
Thus,
imposing
California's
formal
WSP
requirements
on
a
nationwide
basis
may
place
unnecessary
economic
burdens
on
States
that
do
not
have
the
infrastructure
or
resources
to
manage
such
a
process.
See
response
#
81.

128
MBIP
We
have
already
addressed
the
problems
and
burdens
of
imposing
a
California­
See
response
#
81.
29
#
ID
Public
Comment
Agency
Response
style
permitting
system
for
commodity
fumigation
on
a
nationwide
basis.
The
California
system
relies
heavily
on
an
established
infrastructure
of
county
agricultural
commissioners
who
review
and
issue
permits
for
applications.
Enforcement
systems
already
exist
at
the
State
and
Federal
level
to
ensure
compliance
with
pesticide
labeling.
EPA's
entire
pesticide
regulatory
program
is
based
on
controlling
use
through
labeling,
not
permitting
requirements.
EPA
cites
no
evidence
to
suggest
that
fumigators
would
use
methyl
bromide
in
ways
inconsistent
with
the
label.
Rather
than
impose
a
large
administrative
permitting
burden
on
the
states,
we
urge
EPA
to
consider
other
options,
such
as
additional
training
and
certification
for
fumigators.
129
APHIS
APHIS
considers
the
APHIS
PPQ
fumigation
site­
certification
to
be
the
functional
equivalent
to
a
permitting
system
is
overseen
by
the
Federal
entity,
APHIS
PPQ,
and
does
not
believe
that
additional
permitting
would
add
to
the
safety
of
these
facilities.
See
response
#
81.

130
Royal
Record
Keeping/
Reporting/
Tracking.
Royal
believes
that
responsible
fumigation
companies
already
engage
in
more
record­
keeping
than
this
proposal
seems
to
contemplate,
and
therefore
has
no
objection
to
the
proposal.
The
Agency
appreciates
the
information
provided
by
this
commenter
and
has
considered
this
information,
along
with
other
pertinent
data,
in
its
alternatives
and
user
impact
analysis
for
the
proposed
risk
mitigations..
131
NRDC
Record
keeping/
reporting/
tracking.
There
are
currently
no
requirements
on
EPA
labels
for
site
operators
to
keep
records
of
equipment
testing
or
applications
made.
Reporting
and
tracking
of
site
plan
information
will
be
extremely
helpful
for
regulators
to
ensure
compliance
with
labeling
and
regulations.
NRDC
supports
a
record
keeping/
reporting/
tracking
program
as
a
way
to
capture
use
and
compliance,
and
to
assist
with
enforcement.
See
response
#
130.

132
APHIS
Facilities
fumigating
under
APHIS
PPQ
supervision
already
have
their
enclosures
approved
by
APHIS
PPQ.
APHIS
does
not
believe
that
further
record­
keeping
requirements
would
add
to
the
safety
of
these
particular
operational
facilities.
See
response
#
130.

133
FS&
S
Risk
Management
Option
11
 
Record
Keeping
/
Report
/
Tracking
Calibration
of
monitoring
equipment
and
documentation
of
expiration
dates
of
colormetric
tubes
should
be
part
of
an
effective
FMP.
See
response
#
130.

134
PFI
As
to
record
keeping,
PFI
member
companies
already
maintain
extensive
records
on
the
fumigations
in
their
facilities
during
the
normal
course
of
business.
Since
these
applications
are
costly
and
involve
significant
downtime,
and
that
the
applicators
are
already
required
to
keep
extensive
records
under
current
regulations,
PFI
feels
the
existing
record
keeping
need
is
adequate
and
routinely
surpassed,
alleviating
the
need
for
additional
record
keeping
requirements.
See
response
#
5.

135
MBIP
Most
fumigators
already
keep
detailed
records
of
their
operations
as
required
under
USDA
regulations
for
certified
applicators.
However,
a
uniform
program,
developed
in
cooperation
with
fumigators,
could
help
to
ensure
compliance
and
proper
use
of
methyl
bromide.
136
Royal
Training
and
Certification.
Royal
notes
that
fewer
companies
are
engaging
in
fumigation,
in
part
because
of
the
higher
risk
and
the
very
high
insurance
premiums
resulting
from
that
risk.
Therefore,
there
already
exists
in
the
industry
considerable
incentive
for
training,
and
the
methyl
bromide
manufacturers
offer
good
stewardship
programs
on
the
safe
handling
of
fumigants.
In
addition,
most
of
the
state
agencies
in
charge
of
the
certification
of
pest
control
applicators
also
offer
certifications
in
fumigation,
including
commodity
fumigation.
Royal
believes
the
public
is
adequately
protected
already
in
terms
of
training
and
certification,
and
that
another
layer
of
regulation
will
not
improve
the
situation.
See
response
#
5.

137
NRDC
Training
and
certification.
EPA
proposes
a
training
program
specifically
designed
for
the
unique
hazards
that
commodity/
structural
fumigators
are
faced
with.
The
program
could
be
associated
with
programs
already
underway.
NRDC
supports
a
training
and
certification
program
as
a
way
to
reduce
label
violations.
See
response
#
5.

138
FS&
S
Risk
Management
Option
12
 
Training
and
Certification:
This
is
a
huge
issue.
I
do
not
understand
the
full
capability
of
APHIS
and
how
they
could
take
this
issue
on.
There
is
an
absolute
need
to
review
restricted
use
licensing
across
the
US.
There
is
a
wide
range
of
differences
in
licensing
requirements
from
state
department
of
agriculture
to
public
health
to
plant
boards.
Some
state
groups
require
continuing
educations
some
do
not.
Those
who
do
not
require
continuing
education
are
putting
users
of
fumigants
at
great
risk.
Educational
materials
can
be
very
weak,
very
outdated
or
absent.
Many
fumigation
tests
are
very
outdated.
Currently
when
our
company
provides
state
training
for
fumigation,
we
have
trouble
providing
most
recent
information
due
to
conflict
with
old
testing
 
you
must
answer
questions
with
"
currently
incorrect
/
illegal"
information.
There
is
a
real
need
to
channel
changes
in
restricted
use
chemical
to
state
agencies
in
a
timely
manner.
See
response
#
5.
30
#
ID
Public
Comment
Agency
Response
139
MBIP
The
MBIP
generally
supports
to
use
of
training
and
certification
requirements
as
an
effective
way
to
minimize
worker
and
bystander
risk
from
potential
inhalation
exposures
during
commodity
fumigations.
In
1999­
2000,
methyl
bromide
registrants
recognized
the
need
for
additional
training
for
applicators,
and
held
discussions
with
EPA
to
develop
a
training
program.
A
curriculum
was
developed,
reviewed
by
EPA
and
adopted
by
registrants.
Since
2001,
at
least
one
registrant
has
required
applicators
to
show
evidence
of
training
before
purchase
of
methyl
bromide
for
commodity
or
structural
fumigation.
The
program
is
now
voluntary,
but
could
be
made
mandatory,
perhaps
with
an
updated
or
revised
curriculum.
Need
RD
input
140
APHIS
APHIS
believes
that
potential
liability
issues
that
may
arise
from
using
a
dangerous
chemical
requiring
extremely
technical
knowledge
for
safe
application
already
compels
APHIS,
the
product
manufacturer,
and
the
fumigation
companies
to
provide
intensive
certification
for
its
employees
and
clients,
and
that
further
certification
requirements
may
not
add
to
the
safe
use
of
this
product.
Methyl
bromide
labels
already
contain
a
statement
that
the
product
may
only
be
sold
to
persons
certified
and
licensed
in
fumigation.
For
example,
the
Meth­
O­
Gas
Q
products
states,
"
For
retail
sale
to
and
use
only
by
Certified
Applicators
or
persons
under
their
direct
supervision,
and
only
for
those
uses
covered
by
the
Certified
Applicator's
certification"
(
emphasis
added).
All
APHIS
PPQ
employees
which
supervise
fumigations
are
Federally
licensed
and
certified
for
regulatory
fumigation
through
APHIS
PPQ's
Professional
Development
Center.
The
APHIS
PPQ
Compliance
Agreement's
Operational
Procedures
require
that
the
fumigator
provide
to
APHIS
proof
of
the
fumigator's
as
well
as
the
fumigator's
employees'
current
state
license
to
use
restricted­
use
fumigants,
as
well
as
official
documentation
of
approved
training
of
all
non­
certified
personnel
engaged
in
fumigation
operations
under
APHIS
PPQ
supervision.
The
Operational
Procedures,
as
well
as
the
pesticide
labels,
also
require
a
minimum
of
two
certified
persons
present
during
all
fumigations.
The
manufacturers
have
a
great
stake
in
ensuring
that
their
products
are
being
used
safely;
they
provide
a
rigorous
training
course.
Most,
if
not
all
fumigation
companies
send
their
employees
to
intensive
fumigation
training
offered
by
companies
which
manufacture
or
sell
methyl
bromide.
A
reliable
fumigation
company,
who
also
has
a
great
stake
in
ensuring
safety
of
their
employees,
will
often
depend
not
only
on
this
training,
but
also
on
additional
policies
to
ensure
employee
safety.
For
example,
some
companies
require
newer
employees
to
go
through
an
apprenticeship
under
more
seasoned
employees
before
they
are
permitted
to
fumigate
on
their
own.
While
it
appears
that
EPA
Certification
and
Training
regulations
in
40
CFR
may
not
have
kept
up
with
current
State
fumigation
requirements,
most
States
have
already
incorporated
fumigation
categories
into
their
certification
and
training
requirements.
The
many
types
of
protections
in
place
exceed
that
which
EPA
may
propose,
and
may
be
less
of
a
value
added
and
more
of
an
administrative
burden.
See
response
#
81.

141
Royal
Maximum
Application
Rates.
It
is
Royal's
understanding
that
existing
label
rates
are
set
based
upon
the
efficacy
needed
to
protect
American
agriculture
and
safeguard
the
public.
We
question,
therefore,
whether
there
are
"
lower
rates
that
are
still
efficacious,"
but
we
lack
the
expertise
necessary
to
comment
further
on
this
proposal.
See
response
#
81.

142
USA
Rice
USA
Rice
does
not
support
reducing
the
amount
of
MeBr
used
any
further.
The
rice
milling
industry
has
already
reduced
the
amount
of
MeBr
per
ft3
due
to
the
price
of
the
gas
and
the
continuing
CUE
process.
Further
reductions
or
limiting
the
amount
of
gas
used
will
lead
to
less
effective
treatments
and
possible
pest
resistance.
See
response
#
81.

143
USA
Rice
USA
Rice
believes
that
application
rates
listed
in
the
label
need
to
be
broad
enough
to
cover
a
wide
variety
of
situations
and
ensure
efficacy
of
the
targeted
pest.
Although
the
majority
of
fumigations
conducted
are
performed
at
lower
label
rates,
there
may
be
situations
where
higher
label
rates
are
necessary,
such
as
quarantine
fumigations.
Specific
commodities
may
have
higher
listed
application
rates.
These
higher
rates
may
be
necessary
if
the
treatment
is
utilized
to
target
pest
within
bulk
commodity
such
as
a
bin
treatment
where
increased
penetration
is
necessary
or
the
target
pest
may
be
difficult
to
kill.
Quarantine
treatments
require
higher
application
rates
to
meet
USDA
treatment
schedule
requirements
and
are
typically
performed
at
port
locations.
Current
product
labeling
allows
for
application
rates
of
methyl
bromide
on
processed
foods
at
1­
to
2
lbs/
1,000
ft3.
In
the
food
industry,
methyl
bromide
is
seldom
applied
at
over
1
lb/
1,000
ft3
for
a
typical
space
fumigation
carried
out
at
a
food­
handling
establishment.
Product
cost
also
impacts
the
decision
to
utilize
methyl
bromide
at
lower
application
rates,
as
customers
do
not
wish
to
purchase
more
product
than
is
necessary
to
complete
a
successful
treatment.
See
response
#
130.
31
#
ID
Public
Comment
Agency
Response
Lastly,
utilizing
methyl
bromide
at
reduced
application
rates
has
serious
potential
for
the
development
of
insect
resistance.
The
food
and
tobacco
industries
already
face
insect
resistance
to
phosphine,
which
resulted
from
insects
exposed
to
sub
lethal
concentrations
of
that
fumigant.
144
Western
In
terms
of
lowering
of
the
existing
fumigation
schedules,
there
does
not
seem
to
be
much
of
an
opportunity
particularly
for
USDA
quarantine
treatments.
Vigorous
employment
of
the
most
effective
sealing
techniques
would
be
the
most
practical
method
to
reduce
consumption
particularly
where
poor
practices
exist.
See
response
#
130.

145
NRDC
Maximum
application
rates.
Current
application
rates
for
commodity
uses
range
from
1
to
9
lbs
ai
per
1000
cu.
ft.
EPA
proposes
that
lower
rates
could
still
be
efficacious
and
would
reduce
MBr
total
volume
use
and
exposure
risks.
However,
the
EPA
also
raises
the
concern
that
reduced
levels
may
lead
to
increased
pest
resistance.
Thus,
it
is
unclear
from
EPA's
description
if
this
mitigation
proposal
will
result
in
significant
reductions
in
the
overall
MBr
use.
Does
EPA
have
data
supporting
its
estimated
impact?
If
so,
what
is
the
source
of
this
data,
and
what
are
the
estimated
savings
in
MBr
purchases
associated
with
this
proposal,
and
what
would
be
the
estimated
impact
on
MBr
total
usage?
Has
EPA
evaluated
the
impact
of
this
restriction
on
the
attractiveness
of
alternative
pest
control
methods?
See
response
#
81.

146
FS&
S
Risk
Management
Option
13
 
Maximum
Application
Rates:
Applications
vary
widely
and
setting
maximum
rates
would
appear
to
be
difficult.
I
believe
RMO
4
and
Half
Loss
Time
[
HLT]
management
is
a
way
to
limit
the
amount
of
fumigant
needed
while
insuring
desired
efficacy.
See
response
#
130.

147
NAMA
Although
the
label
approved
by
the
EPA
allows
for
usage
at
up
to
6.0
lb.
per
1000
cubic
feet,
the
common
dosage
is
1.0
­
1.25
lb.
per
1000
cubic
feet.
An
average
mill
will
contain
1.0
­
2.0
million
cubic
feet.
See
response
#
130.

148
MBIP
Mitigating
risk
through
reduced
application
rates
has
serious
potential
implications
for
reducing
efficacy
and
increasing
the
development
of
insect
resistance.
The
food
and
tobacco
industries
already
face
insect
resistance
to
phosphine,
which
resulted
from
insects
exposed
to
sub­
lethal
concentrations
of
that
fumigant.
Thus,
the
MBIP
does
not
support
application
rate
reduction
as
a
risk
mitigation
tool,
unless
it
is
demonstrated
that
lower
rates
for
specific
types
of
fumigation
are
efficacious.
See
response
#
130.

149
APHIS
APHIS
assumes
that
this
question
pertains
only
to
those
using
methyl
bromide
under
critical
use
exemptions
and
not
those
using
methyl
bromide
for
quarantine
purposes.
All
treatment
rates
for
imported
commodities
are
mandated
by
APHIS
in
accordance
with
the
Plant
Protection
Act
of
2000
and
are
published
in
Title
7
of
the
Code
of
Federal
Regulations.
If
EPA
reduces
treatment
rates
on
the
label
to
amounts
lower
than
those
mandated
by
APHIS,
it
is
possible
that
certain
imported
commodities
may
not
be
permitted
entry
into
this
country
and
would
have
to
be
reexported
or
destroyed.
All
export
quarantine
treatments
are
conducted
at
rates
mandated
by
the
exporting
country,
and
cannot
be
changed
by
the
United
States;
if
EPA
reduces
the
treatment
rates
on
the
label
to
amounts
lower
than
those
mandated
by
importing
countries,
then
certain
domestic
commodities
may
not
be
permitted
entry
into
that
country;
a
resultant
decline
in
exports
may
occur.
Quarantine
treatments
require
a
100%
kill
of
the
pest
of
concern.
Due
to
the
fact
that
new
phytosanitary
issues
continuously
arise
as
a
result
of
our
nation's
increase
in
global
trade,
APHIS
prefers
to
have
the
labeled
treatments
retained
at
rates
somewhat
higher
than
those
currently
mandated
by
APHIS
PPQ.
This
will
allow
flexibility
in
amending
the
mandatory
treatment
rates
as
the
need
arises,
without
having
to
resort
to
a
section
18
request
See
response
#
130.

150
Royal
Alternatives.
Due
to
the
phase­
out
of
many
uses
of
methyl
bromide,
Royal
has
moved
to
alternative
fumigants
where
it
is
able,
and
we
believe
other
fumigators
in
the
industry
have
now
done
the
same.
As
noted
by
EPA,
there
are
no
alternatives
for
the
international
quarantine
uses.
See
response
#
81.

151
Western
Methyl
Bromide
is
the
most
important
tool
available
for
the
fumigation
of
quarantine
pests,
in
or
on
perishable
commodities,
which
cannot
be
controlled
by
either
heat
or
cold
treatments.
International
trade
in
fresh
fruits
and
vegetable
is
heavily
dependent
on
the
use
of
methyl
bromide
when
a
recognizable
quarantine
risk
is
associated
with
those
products.
The
use
of
methyl
bromide
is
equally
important
in
the
control
of
quarantine
pests
associated
with
a
variety
of
other
commercial
products
and
packing
materials.
Denial
of
these
products
in
international
trade,
which
would
be
the
alternative
if
methyl
bromide
fumigation
were
prohibited,
would
cause
staggering
financial
losses
particularly
to
third
world
countries,
which
depend
on
agricultural
trade
for
a
sizable
portion
of
their
Gross
National
Product
(
GNP).
See
response
#
130.

152
ASOEX
Alternatives:
Methyl
bromide
is
the
only
substance,
at
this
time,
that
is
practical
and
effective
for
most
commodities.
As
part
of
its
activities,
ASOEX
has
funded
research
for
the
development
of
alternative
technologies
designed
to
replace,
at
See
response
#
130.
32
#
ID
Public
Comment
Agency
Response
least
in
part,
preshipment
and
quarantine
uses
of
methyl
bromide.
As
of
today,
no
commercially
viable
alternative
exists
to
methyl
bromide
to
achieve
quarantine
security
objectives
set
by
the
USDA/
APHIS.
Although
research
efforts
are
continuing,
we
doubt
that
a
fully
operational
and
economically
feasible
quarantine
treatment
will
be
in
place
in
the
near
future.
153
NRDC
Available
non­
chemical
and
chemical
alternatives
permit
 
indeed
require
 
the
immediate
termination
of
these
MBr
uses
See
response
#
81.

154
NRDC
Availability
of
Alternatives
EPA
states
that
the
use
of
ozone­
friendly
alternatives
is
"
also
a
preferred
mitigation
option",
so
long
as
the
reduce
risk
alternatives
maintain
"
sufficient
efficacy".
In
FY
1999,
the
USDA
Agriculture
Research
Service
(
ARS)
allocated
about
$
14.4
million
toward
research
to
develop
alternatives
to
MBr,
primarily
but
not
solely
focused
on
chemical
replacements.
In
1995,
the
Secretary
of
Agriculture
and
the
Administrator
of
the
U.
S.
EPA
formed
the
Methyl
Bromide
Alternatives
Working
Group
to
track
and
facilitate
adoption
of
alternatives
to
MBr.
The
development
of
MBr
replacements
that
are
not
harmful
to
human
health
and
ecological
systems
are
preferable
for
all
applications
and
under
all
conditions,
and
should
be
the
goal
of
the
EPA.
Taking
into
account
both
recognized
and
effective
non­
chemical
treatment
techniques
(
e.
g.,
heat)
and
other
fumigation
chemicals
(
e.
g.,
sulfuryl
fluoride),
there
is
no
need
or
justification
for
reregistering
these
uses
of
MBr.
While
not
the
only
efficacious
alternative
pest
control
method
for
these
applications,
NRDC
notes
that
sulfuryl
fluoride
is
registered
for
virtually
all
of
these
uses
both
federally
and
in
all
50
states.
Implemented
with
proper
attention
to
integrated
pest
management
principles,
alternatives
are
capable
of
replacing
virtually
all
MBr
for
these
uses.
In
the
2006
critical
use
exemption
rule
issued
under
the
Clean
Air
Act,
EPA
arbitrarily
assumed
that
sulfuryl
fluoride
can
displace
no
more
than
15
percent
of
the
structural
uses
of
methyl
bromide
in
2006.
EPA
asserted,
without
any
rational
basis,
that
it
would
take
as
much
as
eight
years
for
these
uses
to
transition
from
MBr
to
sulfuryl
fluoride
or
other
alternatives.
In
that
rulemaking,
NRDC
commented
that
EPA's
reasoning
ignores
a
key
aspect
of
the
phase­
out
process
under
the
Montreal
Protocol
and
the
Clean
Air
Act:
phase­
out
timetables
are
intended
to
accelerate
the
market
penetration
of
alternatives.
But
the
market
penetration
of
sulfuryl
fluoride
will
be
inhibited,
not
accelerated,
as
long
as
EPA
allows
methyl
bromide
to
remain
available
for
uses
that
the
new
chemical
could
address
in
the
old
chemical's
absence.
Put
another
way,
if
EPA
has
found
a
15
percent
annual
penetration
rate
is
reasonable
when
there
is
no
environmental
reason
to
replace
an
established
chemical,
then
it
stands
to
reason
that
a
faster
penetration
rate
for
alternatives
is
feasible
when
driven
by
an
environmental
priority
enshrined
in
treaty
and
statute
 
in
this
case
protection
of
the
ozone
layer.
The
same
considerations
apply
here.
Under
FIFRA
and
FQPA,
EPA
cannot
just
take
for
granted
the
transition
time
that
the
agency
believes
to
be
applicable
absent
regulation
and
make
that
the
basis
of
its
regulation.
Rather,
EPA
needs
to
assess
the
ability
of
the
alternatives
to
meet
pest
control
needs
assuming
the
cancellation
of
MBr.
There
is
no
reason
to
allow
more
than
a
year
for
the
transition
from
MBr
to
the
present
suite
of
alternatives.
See
response
#
130.

155
FS&
S
Risk
Management
Option
 
14
Alternatives
At
the
present
time
and
as
I
respond
to
the
agency's
comments
I
am
monitoring
a
sulfuryl
fluoride
fumigation
of
a
mill.
I
would
like
to
use
this
site
to
compare
and
contrast
methyl
bromide
and
sulfuryl
fluoride.
1]
Time
to
prepare
 
same.
2]
Sealing
process
 
same.
3]
Method
of
application
­
methyl
bromide
was
internal
release.
Sulfuryl
fluoride
is
external
release.
4]
Amount
of
gas
used
and
cost
 
Methyl
bromide
2500
lbs.
[$
16,500].
Sulfuryl
fluoride
3500
lbs
[$
17,000].
This
is
the
first
time
we
have
used
SF
on
this
facility
and
we
expect
to
work
the
dosage
rate
and
cost
down
with
the
use
of
the
Fumiguide.
5]
Duration
of
fumigation
 
same­
24
hours.
6]
Monitoring
method
 
same
 
both
use
the
Fumiscope
[
the
same
unit
switches
between
methyl
bromide
and
sulfuryl
fluoride].
7]
Length
of
aeration
 
same.
8]
Clearance
device
 
Methyl
bromide
used
color­
metric
tubes.
Sulfuryl
fluoride
uses
an
electronic
monitor.
Color­
metric
tubes
only
give
you
a
specific
sample
where
electronic
monitors
give
you
continuous
monitoring.
9]
Clean
up
 
same.
10]
Disposal
 
same
 
ship
empty
cylinders
back
to
manufacturer.
We
have
converted
many
facilities
from
methyl
bromide
to
other
treatment
See
response
#
130.
33
#
ID
Public
Comment
Agency
Response
methods
 
mostly
sulfuryl
fluoride
[
SF].
We
have
successfully
used
SF
in
old
and
new,
loose
and
tight
mills,
food
processing
and
warehousing
facilities.
I
work
for
a
large
scale
fumigation
company
who
has
complied
with
methyl
bromide
phase
out
and
use
no
CUE
gas
for
the
last
year
and
half.
We
have
completely
converted
non­
QPS
business
to
alternatives
with
no
negative
impact
on
our
business.
We
are
a
living
example
of
how
this
process
can
work.
Our
customers
have
not
paid
more
and
they
have
not
compromised
treatment
results.
I
find
it
strange
that
so
many
people
find
this
to
be
"
not
possible."
156
PFI
No
Alternatives
to
Methyl
Bromide
The
use
of
methyl
bromide
is
a
vital
tool
in
maintaining
pest­
free
conditions
in
pet
food
processing
facilities.
Methyl
bromide
is
used
as
a
fumigant
to
control
stored
product
pests.
Pet
food
retailers
and
consumers
have
zero
tolerance
for
any
pests
in
finished
products.
To
that
end,
there
are
currently
no
other
alternatives
to
methyl
bromide
for
use
in
pet
food
facilities.
Some
chemicals
can
result
in
severe
damage
to
electrical
equipment
while
others,
most
notably
sufuryl
fluoride,
are
not
currently
approved
for
use
at
all
in
pet
food
facilities
containing
any
amount
of
finished
products.
Improved
sanitation
and
pest
mitigation
steps
help,
but
the
need
for
occasional
methyl
bromide
treatments
remains.
See
response
#
130.

157
DOW
Below
is
a
listing
of
included
documents
containing
data
that
support
ProFume
gas
fumigant
as
an
effective
alternative
to
methyl
bromide
for
post­
harvest
uses.
These
documents
demonstrate
ProFume's
technical
and
economic
viability
as
a
methyl
bromide
alternative.
Many
of
these
documents
were
submitted
to
USEPA 
BEAD
as
public
comments
to
support
the
2006
allocation
rule
as
well
as
2008
US
critical
use
nomination
analysis.
There
are
14
documents
sent
with
this
letter.
They
are:
1.
File
1
SPIP
Rebound
before
and
after
fumigation;
2.
File
2
Flour
Beetle
activity
in
a
mill;
3.
File
3
SF
Vs
MB
fumigation
comparison;
4.
File
4
ProFume
field
bioassay;
5.
File
5
ProFume
TM
fumigation
of
rice
mills
in
California
6.
File
6
Commercial
performance
of
ProFume;
7.
File
7
ProFume
commercial
fumigation
detail;
8.
File
8
Red
Flour
Beetle
monitoring
after
MB
Fumigations
9.
File
9
Economics
of
commercial
ProFume
fumigations;
10.
File
10
Canadian
ProFume
PMRA
registration
efficacy
evaluation;
11.
File
11
Development
of
Sulphuryl
Fluoride
in
China;
12.
File
12
U.
S.
Cocoa
Manufacturer's
Association;
13.
File
13
Testimonials
&
Letters
of
Support;
14.
File
14
Current
ProFume
Registration
Status
See
response
#
130.

158
MBIP
The
MBIP
does
not
see
the
relevance
of
alternatives
to
EPA's
assessment
of
risks
for
methyl
bromide
or
risk
management
decision­
making.
If
efficacious,
safer
and
economically
feasible
alternatives
were
available,
applicators
and
facility
operators
would
be
using
them.
The
transition
to
alternatives
is
already
being
forced
by
the
reduced
availability
and
increased
costs
of
methyl
bromide
via
controls
imposed
by
the
Montreal
Protocol
(
Critical
Use
Exemption
process)
and
the
federal
Clean
Air
Act.
Persons
wanting
to
use
methyl
bromide
under
the
CUE
process
are
required
each
year
in
their
application
to
document
in
great
detail
the
reasons
that
alternatives
are
not
available.
Typical
CUE
applications
can
be
supplied
if
needed
to
demonstrate
support
the
claim
that
feasible
alternatives
are
not
available.
See
response
#
81.

159
NAMA
The
industry
is
experimenting
widely
with
potential
alternatives,
with
mixed
success.
As
an
example,
high
heat
treatments
are
used
around
the
world
to
disinfest
mills
and
have
shown
some
promise
in
certain
facilities
in
the
US.
However,
industry­
wide
experiences
with
heat
treatments
emphasize
the
importance
of
the
structural
integrity
of
the
mill.
Some
mills
have
experienced
structural
damage
from
the
expansion
and
contraction
inherent
to
a
high
heat
treatment.
Also,
most
mills
have
been
expanded
over
the
years
and
therefore
a
mixture
of
building
materials
usually
exists.
Brick,
concrete
block,
poured
concrete,
wood
and
metal
can
be
seen
in
different
portions
of
the
same
facility.
Each
of
these
materials
has
a
differing
ability
to
retain
heat
and
uneven
distribution
of
the
heat
is
a
technical
challenge.
Also,
US
mills
are
generally
far
larger
than
their
counterparts
in
other
countries
and
this
size
difference
adds
considerable
technical
challenge.
Mills
do
not
possess
the
heating
capacity
to
raise
the
temperatures
in
the
structure
or
equipment
to
a
level
of
approximately
140
deg
F
and
maintain
that
temperature
for
24
hours
or
longer.
While
120
deg
F
is
insecticidal,
the
higher
temperature
is
targeted
to
penetrate
the
heat
into
the
machinery
and
also
compensate
for
cool
spots
that
inevitably
exist.
Bringing
in
temporary
heating
units
or
installing
permanent
heating
capacity
are
very
expensive.
There
is
considerable
initial
cost
associated
with
outfitting
a
mill
for
heat­
up
including
changing
fire
suppressing
sprinkler
heads,
kick­
outs
on
motors,
etc.
Mills
are
highly
automated
and
the
motors,
wiring,
milling
machinery,
computers
and
other
components
are
not
designed
to
withstand
high
heat.
Those
costs,
however,
are
minor
compared
with
the
lost
production
resulting
from
See
response
#
130.
34
#
ID
Public
Comment
Agency
Response
the
longer
time
necessary
for
alternative
treatments
like
high
heat.
For
example,
a
typical
grain
mill
will
produce
about
1.0
million
pounds
of
milled
product
each
day.
At
a
sales
price
of
about
$
0.15
per
pound,
the
miller
will
lose
$
150,000
for
each
day
the
mill
is
idle.
So
addressing
the
pest
problem
and
getting
the
mill
back
in
operation
as
quickly
as
possible
is
the
highest
priority.
160
Royal
Integrated
Pest
Management.
As
stated
regarding
the
proposal
for
alternatives,
IPM
has
already
been
instituted
wherever
possible
to
replace
or
lessen
the
need
for
fumigation.
See
response
#
81.

161
NAMA
We
have
always
believed
that
an
effective
integrated
pest
management
(
IPM)
program
is
a
component
of
ensuring
good
sanitation.
This
includes
non­
chemical
and
chemical
means
so
as
to
minimize
the
reliance
on
any
one
tool,
and
maximize
the
opportunity
to
produce
wholesome
food
products
in
a
sanitary
environment.
Nonetheless,
is
spite
of
an
effective
IPM
program
live
infestation
can
be
present
and
hidden
in
the
complex
milling
systems.
The
grain
mill
cited
above
must
process
about
22,000
bushels
or
1.32
million
pounds
of
grain
each
day
to
make
1.0
million
pounds
of
product.
The
Official
United
States
Standards
for
Grain
specifically
allow
live
insect
infestation
in
the
grain.
So
while
IPM
programs
are
useful
and
universally
used,
they
are
inadequate
by
themselves
to
prevent
or
eliminate
pest
infestation.
See
response
#
130.

162
FS&
S
Risk
Management
Option
15
 
Integrated
Pest
Management
(
IPM):
Yes
 
this
is
a
good
idea.
"
Start
with
the
pest
first."
See
response
#
81.

163
MBIP
EPA
is
correct
in
stating
that
effective
IPM
programs
can
result
in
a
reduction
in
the
frequency
of
treatments
and
in
the
amount
of
methyl
bromide
used.
Because
of
the
cost
of
methyl
bromide,
few
food
processing
facilities
are
continuing
to
fumigate
at
regular
intervals,
whether
needed
or
not.
A
uniform
requirement
for
IPM
programs
could
be
helpful.
See
response
#
81.

164
NRDC
To
further
refine
the
USEPA
risk
assessment,
the
U.
S.
Government­
specified
MBr
use
rates
listed
above
should
define
the
range
of
MBr
use
rates
utilized
for
input
in
the
air
dispersion
modeling.
In
addition,
to
reduce
human
inhalation
exposures
and
to
prevent
the
unnecessary
use
of
MBr,
product
labeling
should
be
amended
to
prohibit
product
use
rates
that
exceed
the
upper
values
specified
in
the
table.
See
response
#
81.

165
NRDC
Air
monitoring/
modeling
data.
EPA
suggests
allowing
facilities
to
use
a
smaller
(
less
protective)
buffer
zone
if
they
demonstrate
using
air
models
and
modeling
that
concentrations
would
be
below
the
EPA
level
of
concern
even
reflecting
a
worst
case
scenario.
NRDC
does
not
support
this,
and
believes
that
any
application
that
is
in
violation
of
the
label
is
a
legal
violation
of
FIFRA.
If
representative
air
monitoring/
modeling
data
for
a
specific
site
shows
that
a
smaller
buffer
zone
for
that
site
would
not
result
in
risks
of
concern,
applications
at
that
site
would
not
be
in
violation
of
FIFRA.
166
MBIP
As
discussed
previously
in
Section
D
(
Buffer
Zones),
with
the
availability
of
sensitive
electronic
devices
for
detection
of
methyl
bromide,
routine
monitoring
during
fumigations
has
become
a
more
realistic
option.
The
MBIP
supports
the
use
of
monitoring
in
lieu
of
fixed
buffer
zones
to
allow
maximum
flexibility
to
applicators
and
facilities.
Also,
facilities
should
have
the
option
of
using
modeling
to
demonstrate
that
their
plans
for
fumigation
are
sufficiently
protective.
See
response
#
130.

167
APHIS
Methyl
bromide
has
been
used
at
our
nation's
ports
for
over
20
years;
APHIS
has
no
records
of
any
adverse
affects
suffered
by
persons
who
abide
by
the
label
and
the
APHIS
PPQ
fumigation
requirements.
If
regulations
or
labels
change
the
current
buffer
policy,
APHIS
would
like
to
see
evidence
of
the
value
added
by
mandating
such
changes,
including
more
recent
air
concentration
monitoring
data.
See
response
#
130.

168
APHIS
APHIS
is
in
full
agreement
that
air
monitoring
is
a
safe
and
effective
way
to
protect
workers
involved
with
methyl
bromide
fumigation.
While
permanent
devices
have
been
developed
to
take
ambient
air
concentration
readings
as
low
as
1
ppm,
no
portable
devices
have
been
developed
which
can
take
accurate
readings
at
the
1
ppm
level.
Portable,
hand­
held
devices
can
only
give
accurate
concentration
readings
to
about
2
ppm
(
±
1
ppm).
APHIS
PPQ
employs
a
permanent
continuous
air
monitoring
device
in
two
ports
where
the
highest
numbers
of
phytosanitary
fumigations
of
food
commodities
occur
in
this
nation:
Miami
AirCargo
and
Miami
Maritime.
Since
over
25
fumigations
may
be
occurring
at
one
time
(
all
during
daylight
hours),
PPQ
officers
must
be
continuously
taking
readings
of
the
gas
concentrations
within
the
fumigation
enclosures
to
determine
whether
the
levels
within
the
enclosure
are
high
enough
to
ensure
treatment
efficacy.
The
device
is
set
up
and
maintained
in
a
permanent
office
where
lines
carrying
gas
from
each
fumigation
enclosure
pass
through
a
thermal
conductivity
analyzer
which
reads
gas
concentrations
within
each
enclosure.
Due
to
the
continuous
amount
of
gas
passing
through
the
office
and
to
protect
the
health
and
safety
of
APHIS
PPQ
employees,
the
ambient
air
monitoring
device,
called
a
Methyl
Bromide
Pyrolyzer
Detection
System
(
minimum
detection
level
of
1
ppm,
an
accuracy
of
±
5%,
and
a
price
within
the
$
5,000
range)
is
set
up
to
sound
an
alarm
if
air
concentrations
reach
1
ppm.
The
See
response
#
130
35
#
ID
Public
Comment
Agency
Response
busiest
season
in
Miami
(
imported
asparagus)
is
between
October
and
January;
nearly
all
food
commodities
are
fumigated
in
individual
containers;
the
volume
of
the
biggest
enclosure
is
2926
cubic
feet
and
the
maximum
treatment
is
4
lb/
1,000
cubic
feet
(
for
food),
so
the
maximum
amount
introduced
into
each
enclosure
is
a
little
less
than
a
mere
12
lb.
Despite
the
fact
that
the
permanent
reading
office
is
located
30'
(
Maritime)
to
50'
(
Air
Cargo)
from
the
nearest
fumigation
enclosure
and
personnel
are
present
even
during
aeration
events,
there
have
been
no
events
which
have
caused
the
alarm
to
sound
since
the
new
unit
was
installed
at
Miami
Maritime
last
October.
As
already
mentioned,
the
continuous
air
monitoring
system
employed
in
the
two
Miami
locations
is
a
permanent,
not
a
portable,
device.
Many
if
not
most
of
the
locations
where
APHIS
PPQ
employees
take
gas
concentration
readings
during
the
treatment
phase
of
fumigation
are
in
temporary,
multi­
use
areas,
such
as
a
table
located
30
feet
beyond
the
fumigation
site.
Few
gas
concentration
readings
are
conducted
in
permanent
structures,
as
they
are
in
Miami
and
Baltimore
(
where
EPA
toured.)
Therefore,
this
technology
is
not
usable
for
most
locations
where
APHIS­
supervised
fumigations
occur.
169
0204
Notification/
Posting.
Current
product
labels
already
require
placarding
and
securing
of
fumigation
sites.
In
addition,
responsible
fumigators
notify
local
emergency
responders,
such
as
fire
departments,
of
their
activities.
Royal
does
not
believe
that
additional
requirements
are
needed.
See
response
#
81.

170
NRDC
Notification/
posting.
EPA
is
proposing
that
fumigation
activities
be
posted
in
public
locations
so
that
bystanders
could
take
steps
to
protect
themselves.
NRDC
supports
the
use
of
notification
and
posting,
but
does
not
support
its
use
as
an
alternative
to
significant
reduction
and
cancellation
of
MBr
uses.
Shifting
the
burden
of
protection
from
users
to
bystanders
is
unacceptable.
The
Agency
is
not
implying
that
notification/
posting
be
used
in
place
of
another
risk
mitigation
option.
However,
the
Agency
does
believe
that
there
is
value
in
informing
the
public
so
that
they
can
take
steps
to
protect
themselves
in
the
event
of
accidental
exposures.
171
0220.1
FS&
S
Risk
Management
Option
17
 
Notification
/
Posting:
We
currently
do
this
with
a
fumigation
preparation
guide
as
part
of
a
more
comprehensive
FMP.
This
form
includes
sensitive
material
and
an
employee
posting
or
notification.
This
notice
is
to
be
placed
near
time
clocks,
employee
information
boards,
main
entrances
and
shipping
delivery
entrances.
Other
important
notices
are
regular
delivery
people,
employees
on
leave
and
home
office
[
anyone
with
a
key
to
the
facility].
See
response
#
81.

172
NAMA
Oral
notification
We
oppose
oral
notification.
It
is
already
a
requirement
that
appropriate
signage
be
posted.
Additionally,
as
was
stated
earlier,
security
guards
on
the
property
warn
and
turn
away
bystanders
approaching
the
facility.
These
practices
have
proven
effective.
Oral
notification
would
not
add
to
safe
usage,
and
may
needlessly
worry
the
public.
See
response
#
81.

173
MBIP
Warning
signs
are
already
required
when
facilities
are
fumigated.
Fumigators
are
required
to
make
certain
all
non­
authorized
personnel
have
vacated
the
facility
and
the
immediate
surrounding
area.
Other
communication
methods
(
i.
e.,
verbal
notification)
is
unnecessary,
particularly
if
monitoring
is
conducted.
See
response
#
81.

174
APHIS
The
PPQ
Treatment
Manual,
in
Chapters
2­
3,
2­
4,
2­
5,
2­
6,
2­
7,
and
2­
8
(
http://
www.
aphis.
usda.
gov/
ppq/
manuals/
port/
Treatment_
Chapters.
htm)
is
replete
with
official
requirements
for
notification,
posting,
and
placarding
during
treatment
and
aeration.
At
least
one
label
(
the
methyl
bromide
quarantine
label;
EPA
Reg.
No.
5784­
41;
Great
Lakes
Chemical
Corp.)
already
has
a
section
devoted
to
placarding
and
notification.
Most
fumigators
verbally
notify
nearby
port
workers
when
treatments
and
aeration
begin,
not
only
out
of
conscientiousness,
but
also
for
liability
reasons.
APHIS
does
not
see
how
adding
label
requirements
on
that
which
is
already
being
performed
will
add
to
safety.
See
response
#
130.

175
NPMA
NPMA
is
concerned
that
EPA's
proposed
risk
mitigation
measures
are
based
largely
on
California's
regulatory
system.
California
has
arguably
the
most
resource
intensive
state
pesticide
regulatory
system
in
the
country,
and
simply
rubber­
stamping
California
requirements
and
asking
other
state
regulatory
agencies
to
enforce
them
is
completely
impractical.
No
other
state
has
a
statecounty
pesticide
regulatory/
enforcement
setup
like
California,
and
it
does
not
appear
at
this
time
other
states
are
looking
to
implement
such
an
arrangement.
Under
California's
regulatory
approach,
each
County
Agricultural
Commissioner
is
charged
with
issuing
site
specific
permits
for
each
site
that
will
be
fumigated
with
methyl
bromide.
The
conditions
the
Commissioners
should
consider
are
outlined
in
a
155­
page
CADPR
document
entitled,
"
Reference
Manual:
Methyl
Bromide
Commodity
Fumigation."
NPMA
does
not
believe
other
states
have
the
resources
or
are
equipped
to
issue
site
specific
permits.
See
response
#
1
176
NPMA
NPMA
is
encouraged
that
the
Agency
does
acknowledge
the
value
and
usefulness
See
response
#
81.
36
#
ID
Public
Comment
Agency
Response
of
Fumigation
Management
Plans,
and
believes
that
the
Plans
adequately
address
possible
bystander
exposure
issues.
The
labels
of
products
containing
aluminum
and
magnesium
phosphide
have
required
applicators
to
develop
Fumigation
Management
Plans
since
the
compounds
were
reregistered
a
few
years
ago,
and
the
Plans
seem
to
be
working
effectively.
The
new
phosphine
labels
have
clearly
shown
that
Fumigation
Management
Plans
make
buffer
zones
and
most
of
the
other
RMM's
the
Agency
has
proposed
completely
unnecessary.
177
IFC
IFC
supports
the
use
of
site­
specific
Futnigation
Management
Plans
to
lielp
fumigators
anticipate,
recognize,
and
evaluate
factors
that
lead
to
a
safe
treatment.
Advanced
planning
with
facility
managers
always
has
been
critical
for
ensuring
site
safety.
Written
plans
lielp
document
and
effectively
communicate
what
will
happen
in
order
to
complete
a
safe,
effective,
and
legal
fumigation
with
all
parties
involved.
See
response
#
49.

178
IFC
We
also
support
improved
training
and
certification
requirements
for
the
use
of
fumigants.
Fumigants
are
a
very
specialized
pest
management
tool
utilized
by
a
very
small
percentage
of
pest
management
professionals.
There
is
currently
a
need
for
funding
of
good
training
and
educational
materials
that
the
states
could
utilize
in
order
to
update
and
strengthen
their
existing
programs.
States
already
have
established
fumigation
categories
within
their
licensing
and
certification
programs.
What
some
states
may
lack
are
up­
to­
date
training
materials.
Fumigants
are
a
unique
pest
management
tool
and
are
not
readily
available.
Most
individuals
who
oversee
State
Pesticide
programs
have
limited
practical
knowledge
of
fumigation
practices.
Current
state
training
and
certification
programs
are
not
always
adequate
to
provide
the
same
type
of
specialized
training
that
is
necessary
to
properly
utilize
fumigants.
Good
on­
the­
job
training
programs
combined
with
manufacturer
stewardship
programs
are
a
necessary
part
of
the
process
involved
with
proper
use
of
fumigants.
See
response
#
5.

179
IFC
Establishing
buffer
zones
around
a
treated
site
is
not
an
effective
option
for
managing
risks
from
inhalation
exposure
to
workers
or
bystanders.
The
only
way
to
safely
manage
human
exposure
is
to
ensure
that
proper
air
monitoring
occurs
during
a
treatment.
Reliable
air
monitoring
equipment
is
readily
available
and
provides
real
time,
continuous
monitoring.
An
emphasis
on
proper
air
monitoring
by
trained
individuals
would
eliminate
the
need
for
cumbersome
buffer
zone
restrictions
that
do
little
more
than
create
economic
hardships
and
additional
paperwork.
IFC
has
worked
within
the
California
buffer
zone
system
since
its
inception.
In
our
experience,
none
of
the
21
plus
conditions
required
under
California's
current
buffer
zone
system
can
do
as
much
to
ensure
human
safety
as
simple
on­
site
monitoring.
In
order
to
meet
buffer
zone
conditions,
facilities
that
once
safely
fumigated
critical
areas
of
their
operation
were
forced
to
reduce
dosage,
reduce
areas
treated,
and
treat
at
several
different
dates
throughout
the
year,
or
eliminate
space
fumigations
altogether
and
switch
to
other
less
effective
treatment
options.
The
net
result
of
utilizing
other
treatment
methods
was
an
increased
frequency
of
pesticide
use
and/
or
increased
downtime
and
other
expenses.
See
responses
#
5
and
#
65.

180
IFC
Other
treatment
options
include
heat
treatments,
sulfuryl
fluoride
fumigations,
spot
fumigations
of
equipment
with
phoosphine.
Space
foggings
with
pyretlirin
or
vapona,
and
the
use
of
insect
growth
regulators
and
residual
insecticides.
Heat
is
not
a
good
penetrator
and
typically
requires
repeat
treatments
throughout
the
year,
resulting
in
additional
downtime.
If
heating
systems
are
not
currently
in
place,
the
cost
of
this
option
can
also
be
significant.
Spot
fumigation
of
equipment
with
phosphine
is
typically
performed
in
conjunction
with
a
space
fogging.
Exposure
periods
of
36
hours
for
spot
treatments
do
not
allow
for
complete
hill
of
all
life
stages,
therefore
more
resistant
insect
stages
such
as
the
egg
and
pupae
escape
the
treatment
and
allow
for
population
rebound.
In
order
to
manage
pest
populations,
periodic
spot
treatments
every
four
to
six
weeks
are
necessary.
Space
foggings
provide
contact
kill
only
of
exposed
insects
and
do
not
target
pests
that
are
in
inaccessible
areas.
See
response
#
5.

181
IFC
The
March
29
Federal
Register
stated,
"
for
structural,
commodity
and
other
types
of
applications,
an
application
rate
of
9
lbs
ail1000
ft3
was
used
as
the
basis
for
risk
assessment
purposes."
This
assumption
regarding
use
rate
is
extremely
high
and
does
not
reflect
actual
use
practices.
Application
rates
utilized
for
space
fumigations
of
rood
handling
facilities
rarely
exceed
1
lb/
1,000
ft3.
Targeted
lethal
concentrations
can
be
achieved
at
rates
of
1
lb/
l,
000
ft3
and
allow
for
cost
control
of
material
utilized.
Reduced
dosage
rates
that
have
been
required
to
meet
California's
buffer
zones
pose
problems
with
reduced
penetration
capabilities,
increased
fumigation
periods,
and
a
real
potential
for
the
development
of
insect
resistance.
See
response
#
31.

182
IFC
Notification
and
posting
of
the
treated
site
is
already
a
labeling
requirement.
See
response
#
5.
37
#
ID
Public
Comment
Agency
Response
Facility
management
notifies
personnel
of
the
upcoming
treatment
well
in
advance
to
allow
for
evacuation
of
the
site
during
treatment.
Exclusion
of
all
personnel
from
the
treated
area
has
always
been
standard
practice
for
space
fumigations
of
food
handling
facilities.
The
fumigation
crew
and
posted
guard
are
on­
site
during
time
treatment
and
aeration
process,
during
which
time
air
monitoring
is
conducted
to
ensure
established
safe
levels
are
not
exceeded.
183
IFC
Arbitrary
aeration
times
can
be
restrictive
and
are
useless
in
determining
when
a
facility
has
been
completely
aerated.
Gas
monitoring
is
the
only
way
to
be
certain
all
safety
requirements
are
met.
There
is
no
universal
buffer
zone
that
will
accomplish
this
safe
practice
within
practical
and
cost
efficient
limits.
Therefore
we
are
opposed
to
any
nationwide
buffer
zone
requirement.
See
response
#
5.