Document ID: EPA-HQ-OPP-2002-0142-0001
Agency: epa
Document Type: Rule
Title: 1-Methylcycloropene; Exemption from the Requirement of a Tolerance
Posted Date: 2002-07-26T04:00Z

48796
Federal
Register
/
Vol.
67,
No.
144
/
Friday,
July
26,
2002
/
Rules
and
Regulations
*
*
*
*
*
[
FR
Doc.
02
 
18867
Filed
7
 
25
 
02;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2002
 
0142;
FRL
 
7187
 
4]

1­
Methylcyclopropene;
Exemption
from
the
Requirement
of
a
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
1­
Methylcyclopropene
(
1­
MCP)
in
or
on
fruits
and
vegetables
when
used
as
a
post
harvest
plant
growth
regulator,
i.
e.,
for
the
purpose
of
inhibiting
the
effects
of
ethylene.
AgroFresh,
Inc.
(
formerly
BioTechologies
for
Horticulture)
submitted
a
petition
to
EPA
under
the
Federal
Food,
Drug,
and
Cosmetic
Act,
as
amended
by
the
Food
Quality
Protection
Act
of
1996,
requesting
an
exemption
from
the
requirement
of
a
tolerance.
This
regulation
eliminates
the
need
to
establish
a
maximum
permissible
level
for
residues
of
1­
MCP.
DATES:
This
regulation
is
effective
July
26,
2002.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2002
 
0142,
must
be
received
on
or
before
September
24,
2002.

ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
by
mail,
electronically,
or
in
person.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
IX.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
your
objections
and
hearing
requests
must
identify
docket
ID
number
OPP
 
2002
 
0142
in
the
subject
line
on
the
first
page
of
your
response.

FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
Driss
Benmhend,
c/
o
Product
Manager
(
PM)
90,
Biopesticides
and
Pollution
Prevention
Division
(
7511C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(
703)
308
 
9525;
e­
mail
address:
Benmhend.
driss@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?

You
may
be
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
categories
and
entities
may
include,
but
are
not
limited
to:

Categories
NAICS
codes
Examples
of
potentially
affected
entities
Industry
111
Crop
production
112
Animal
production
311
Food
manufacturing
32532
Pesticide
manufacturing
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
the
table
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
or
not
this
action
might
apply
to
certain
entities.
If
you
have
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Additional
Information,
Including
Copies
of
this
Document
and
Other
Related
Documents?
1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov/.
To
access
this
document,
on
the
Home
Page
select
``
Laws
and
Regulations,''
``
Regulations
and
Proposed
Rules,''
and
then
look
up
the
entry
for
this
document
under
the
``
Federal
Register
 
Environmental
Documents.''
You
can
also
go
directly
to
the
Federal
Register
listings
at
http://
www.
epa.
gov/
fedrgstr/.
A
frequently
updated
electronic
version
of
40
CFR
part
180
is
available
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml_
00/
Title_
40/
40cfr180_
00.
html.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
ID
number
OPP
 
2002
 
0142.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
and
other
information
related
to
this
action,
including
any
information
claimed
as
Confidential
Business
Information
(
CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period
is
available
for
inspection
in
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(
703)
305
 
5805.

II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
June
21,
2000
(
65
FR
38550)
(
FRL
 
6589
 
5),
EPA
issued
a
notice
pursuant
to
section
408(
d)(
3)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a(
d)(
3),
as
amended
by
the
Food
Quality
Protection
Act
(
FQPA)
(
Public
Law
104
 
170),
announcing
the
filing
of
a
pesticide
tolerance
petition
(
PP
OF6144)
by
AgroFrech,
Inc.
(
formerly
BioTechnologies
for
Horticulture,
Inc.),
100
Independence
Mall
West,
Philadelphia,
PA
19106
 
2399.
As
required
by
section
408(
d)(
2)(
A)(
i)(
I),
this
notice
included
a
summary
of
the
petition
prepared
by
the
petitioner
AgroFresh,
Inc.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
Section
408(
c)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
an
exemption
from
the
requirement
for
a
tolerance
(
the
legal
limit
for
a
pesticide
chemical
residue
in
or
on
a
food)
only
if
EPA
determines
that
the
tolerance
is
``
safe.''
Section
408(
c)(
2)(
A)(
ii)
defines
``
safe''
to
mean
that
``
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.''
This
includes
exposure
through
drinking
water
and
in
residential
settings,
but
does
not
include
occupational
exposure.
Section
408(
b)(
2)(
C)
requires
EPA
to
give
special
consideration
to
exposure
of
infants
and
children
to
the
pesticide
chemical
residue
in
establishing
a
tolerance
and
to
``
ensure
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
the
pesticide
chemical
residue.
.
.
.''
Additionally,
section
408(
b)(
2)(
D)
requires
that
the
Agency
consider
``
available
information''
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
``
other
substances
that
have
a
common
mechanism
of
toxicity.''
EPA
performs
a
number
of
analyses
to
determine
the
risks
from
aggregate
exposure
to
pesticide
residues.
First,

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18:
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48797
Federal
Register
/
Vol.
67,
No.
144
/
Friday,
July
26,
2002
/
Rules
and
Regulations
EPA
determines
the
toxicity
of
pesticides.
Second,
EPA
examines
exposure
to
the
pesticide
through
food,
drinking
water,
and
through
other
exposures
that
occur
as
a
result
of
pesticide
use
in
residential
settings.

III.
Toxicological
Profile
Consistent
with
section
408(
b)(
2)(
D)
of
FFDCA,
EPA
has
reviewed
the
available
scientific
data
and
other
relevant
information
in
support
of
this
action
and
considered
its
validity,
completeness,
and
reliability
and
the
relationship
of
this
information
to
human
risk.
EPA
has
also
considered
available
information
concerning
the
variability
of
the
sensitivities
of
major
identifiable
subgroups
of
consumers,
including
infants
and
children.
The
end­
use
product,
a
white
powder,
when
mixed
with
water
or
a
buffer
solution
releases
the
gas
1­
MCP.
The
active
ingredient
acts
an
inhibitor
to
ethylene,
by
blocking
the
attachment
of
ethylene
to
tissue,
and
thus,
prolongs
the
life
of
the
food
commodity
treated.
Toxicity
studies
submitted
in
support
of
the
tolerance
exemption
petition,
and
the
Agency
reviews
are
compiled
in
the
official
record
established
for
this
action
under
the
docket
ID
number
OPP
 
2002
 
0142.
1.
Acute
toxicity
(
MRIDs
444647
 
04
to
08).
1­
MCP
exhibits
low
acute
toxicity.
It
is
a
category
IV
biopesticide.
The
rat
oral
LD50
is
greater
than
5,000
milligrams/
kilograms
(
mg/
kg),
the
rabbit
dermal
LD50
is
greater
than
2,000
mg/
kg
and
the
rat
inhalation
LC50
is
greater
than
2.5
milligram/
liter
(
mg/
L)
(
or
greater
than
1,126
parts
per
million
(
ppm)
v/
v
active
ingredient
in
air).
No
deaths
or
clinical
signs
of
systemic
toxicity
were
observed
following
these
acute
exposures.
1­
MCP
produces
minimal
irritation
of
skin
and
eyes
in
rabbits
and
1­
MCP
is
not
a
skin
sensitizer.
No
hypersensitivity
incidents
were
observed
following
exposure
to
1­
MCP.
2.
Genotoxicity
(
MRID
444647
 
09).
1­
MCP
was
not
mutagenic
when
tested
as
a
gas
in
several
short­
term
in
vitro/
in
vivo
assays,
including
a
bacterial
reverse
mutation
assay
(
Ames
test),
an
in
vitro
mammalian
point
mutation
assay
in
Chinese
hamster
ovary
cells,
an
in
vitro
cytogenetics
assay
in
human
lymphocytes
and
an
in
vivo
mouse
micronucleus
assay
following
inhalation
exposure.
In
addition,
1­
MCP
is
not
mutagenic
when
tested
as
a
suspension
in
cell
media
in
the
Ames
test
and
in
the
in
vitro
mouse
lymphoma
forward
mutation
assay
(
MRID
444647
 
10)
and
is
not
mutagenic
in
the
in
vivo
mouse
micronucleus
assay
(
MRID
444747
 
11)
following
oral
exposure
(
gavage).
3.
Developmental
toxicity
(
MRID
454586
 
08).
1­
MCP
produces
no
developmental
toxicity
when
tested
in
a
standard
developmental
toxicity
study
in
the
rat
via
inhalation
at
concentrations
up
to
and
including
2.3
mg
a.
i./
L
(
or
543
mg
a.
i./
kg/
day,
6
hr
exposure/
day).
The
no
observed
adverse
effect
level
(
NOAEL)
for
maternal
toxicity
was
0.24
mg
a.
i./
L
(
56
mg
a.
i./
kg/
day,
6
hr
exposure/
day).
4.
Subchronic
toxicity
(
MRID
456090­
01).
1­
MCP
was
tested
in
a
90
 
day
inhalation
study
at
doses
of
0.05,
0.24
and
2.3
mg
a.
i./
kg
in
the
rat.
The
NOAEL
is
0.05
mg
a.
i./
L
(
equivalent
to
9
to
15
mg
a.
i./
kg/
day),
based
on
minimal
to
mild
effects
on
spleen
and
kidney
histopathology
at
0.24
mg
a.
i./
L
(
equivalent
to
39
to
66
mg
a.
i./
kg/
day).
In
this
study
there
was
no
evidence
of
neurotoxicity,
no
effects
on
the
respiratory
tract
and
no
effects
on
pathology
of
any
endocrine
or
reproductive
organs
up
to
and
including
the
highest
dose
tested
of
2.3
mg
a.
i./
L
(
or
equivalent
to
380
to
640
mg
a.
i./
kg/
day).
5.
AgroFresh
(
the
applicant)
submitted
a
waiver
request
for
the
immune
response
data
requirements
based
on
the
current
toxicological
data
submitted
on
1­
MCP.
The
review
of
the
3
 
month
inhalation
rat
study
(
mentioned
in
the
previous
paragraph)
indicates,
no
effects
on
thymus
weight
and
no
effects
on
the
histopathology
of
the
thymus,
bone
marrow
or
spleen
that
would
be
attributed
to
an
impact
on
the
immune
system
were
seen.
There
were
no
effects
on
white
blood
cell
differential
parameters
(
including
monocytes,
lymphocytes,
segmented
neutrophils
or
eosinophils)
and
no
basophils
were
observed
which
may
be
indicative
of
an
allergic
reaction.
The
Agency
concluded
that
1­
MCP
did
not
induce
dysfunction
or
inappropriate
suppressive
responses
in
components
of
the
immune
system.
As
a
result,
immune
response
data
requirements
were
waived.
6.
Other.
1­
MCP
has
a
mode
of
action
in
plants
which
is
a
non­
persistent
and
non­
toxic
mode
of
action.
1­
MCP
prevents
the
natural
chemical,
ethylene,
from
binding
to
ethylene
receptors
in
plants.
This
mode
of
action
is
not
relevant
in
animals,
since
ethylene
receptors
are
not
present
in
animal
tissues.

IV.
Aggregate
Exposures
In
examining
aggregate
exposure,
FFDCA
section
408
directs
EPA
to
consider
available
information
concerning
exposures
from
the
pesticide
residue
in
food
and
all
other
nonoccupational
exposures,
including
drinking
water
from
ground
water
or
surface
water
and
exposure
through
pesticide
use
in
gardens,
lawns,
or
buildings
(
residential
and
other
indoor
uses).

A.
Dietary
Exposure
1.
Food
 
From
food
and
feed
uses.
The
primary
source
for
human
exposure
to
1­
MCP
will
be
from
ingestion
of
the
following
raw
food
commodities
and
the
processed
food
commodities
derived
from:
apples,
melons,
tomatoes,
pears,
avocadoes,
mangoes,
papayas,
kiwifruit,
plums,
apricots
and
persimmons.
Studies
submitted
(
MRID
456090
 
02)
showed
residues
in
treated
apples
to
be
extremely
low
(
average
residue
was
0.004
ppm
using
an
exaggerated
treatment
rate
of
1,200
parts
per
billion
(
ppb)
versus
the
1,000
ppb
proposed
label
rate).
A
worst­
case
scenario
(
using
the
0.004
ppm
average
residue
concentration
found
in
treated
apples
and
assuming
that
concentration
is
present
in
100%
of
the
diet
regardless
of
crops
treated)
indicates
that
a
daily
diet
of
1.5
kg/
day
could
contain
0.006
mg
1­
MCP.
For
the
general
population
(
assuming
an
average
body
weight
of
60
kg),
this
would
represent
a
daily
intake
of
0.0001
mg
1­
MCP/
kg
body
weight
which
is
90,000
to
150,000­
fold
less
than
the
9­
15
mg/
kg
NOAEL
indicated
in
the
90
 
day
inhalation
study.
Residues
in
other
treated
commodities
are
expected
to
be
similar
or
even
lower
since
the
highest
treatment
rate
is
recommended
for
apples.
Processing
would
be
expected
to
further
lower
the
residue
levels
in
processed
food
commodities.
2.
Drinking
water
exposure.
Since
1­
MCP
will
only
be
used
on
postharvested
fruits
and
vegetables
in
enclosed
storage
areas,
there
is
little
if
any,
potential
for
drinking
water
exposure.

B.
Other
Non­
Occupational
Exposure
The
potential
for
non­
dietary
exposure
to
1­
MCP
for
the
general
population,
is
unlikely
because
potential
use
sites
are
commercial,
agricultural,
and
horticultural.
1­
MCP
is
currently
registered
for
indoor,
nonfood
commercial
use
on
flowers
and
ornamentals.
The
Agency
has
approved
that
use,
based
on
the
data
submitted
that
show
little
potential
for
significant
non­
occupational
exposure
to
the
general
population.
1.
Dermal
exposure.
1­
MCP
will
only
be
sold
enclosed
in
a
generator
for
treatment
of
raw
agricultural
commodities.
The
generator
will
not
release
1­
MCP
until
the
applicator
has
exited
the
storage
area
and
entrances
to
the
treatment
area
have
been
sealed.
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and
Regulations
the
end
of
the
treatment
period,
the
storage
area
will
be
vented
before
workers
are
permitted
to
reenter
the
area.
This
label
mitigating
language
would
eliminate
the
potential
for
dermal
exposure
to
handlers
or
applicators.
2.
Inhalation
exposure.
As
mentioned
in
the
previous
paragraph,
the
use
of
this
product
according
to
the
label
instructions
would
result
in
little,
if
any,
inhalation
exposure
to
handlers
or
applicators.

V.
Cumulative
Effects
The
Agency
has
considered
the
cumulative
effects
of
1­
MCP
and
other
substances
in
relation
to
a
common
mechanism
of
toxicity.
These
considerations
include
the
possible
cumulative
effects
of
such
residues
on
infants
and
children.
There
is
no
indication
of
mammalian
toxicity
at
the
maximum
doses
tested,
of
this
or
other
products
containing
1­
MCP.

VI.
Determination
of
Safety
for
U.
S.
Population,
Infants
and
Children
1.
U.
S.
population.
There
is
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
residues
of
1­
MCP
to
the
U.
S.
population.
This
includes
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.
The
Agency
has
arrived
at
this
conclusion
based
on
the
very
low
levels
of
mammalian
toxicity
(
no
toxicity
at
the
maximum
doses
tested,
Toxicity
Categories
III
and
IV)
and
the
minimum
exposure
associated
with
1­
MCP's
use.
2.
Infants
and
children.
FFDCA
section
408
provides
that
EPA
shall
apply
an
additional
tenfold
margin
of
exposure
(
safety)
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
prenatal
and
postnatal
toxicity
and
the
completeness
of
the
data
base
unless
EPA
determines
that
a
different
margin
of
exposure
(
safety)
will
be
safe
for
infants
and
children.
Margins
of
exposure
(
safety)
are
often
referred
to
as
uncertainty
(
safety)
factors.
In
this
instance,
based
on
all
the
available
information,
the
Agency
concludes
that
1­
MCP
is
practically
non­
toxic
to
mammals,
including
infants
and
children.
Thus,
there
are
no
threshold
effects
of
concern
and,
as
a
result
the
provision
requiring
an
additional
margin
of
safety
does
not
apply.
Further,
based
on
the
lack
of
observed
developmental
toxicity
and
extremely
low
exposure,
there
is
reasonable
certainty
that
no
harm
to
infants,
children,
or
adults
will
result
from
aggregate
exposure
to
1­
MCP
residues.
Exemption
of
1­
MCP
from
the
requirements
of
a
tolerance
should
pose
no
significant
risk
to
humans
or
the
environment
VII.
Other
Considerations
A.
Endocrine
Disruptors
EPA
is
required
under
the
FFDCA
as
amended
by
FQPA
to
develop
a
screening
program
to
determine
whether
certain
substances
(
including
all
pesticide
active
and
other
ingredients)
``
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally­
occurring
estrogen,
or
other
such
endocrine
effects
as
the
Administrator
may
designate.''
Following
the
recommendations
of
its
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
(
EDSTAC),
EPA
determined
that
there
is
no
scientific
basis
for
including,
as
part
of
the
program,
the
androgen­
and
thyroid
hormone
systems
in
addition
to
the
estrogen
hormone
system.
EPA
also
adopted
EDSTAC's
recommendation
that
the
program
include
evaluations
of
potential
effects
in
wildlife.
For
pesticide
chemicals,
EPA
will
use
FIFRA
and,
to
the
extent
that
effects
in
wildlife
may
help
determine
whether
a
substance
may
have
an
effect
in
humans,
FFDCA
authority
to
require
wildlife
evaluations.
As
the
science
develops
and
resources
allow,
screening
of
additional
hormone
systems
may
be
added
to
the
Endocrine
Disruptor
Screening
Program(
EDSP).
When
the
appropriate
screening
and/
or
testing
protocols
being
considered
under
the
Agency's
Endocrine
Disruptor
Screening
Program
have
been
developed,
1­
MCP
may
be
subjected
to
additional
screening
and/
or
testing
to
better
characterize
effects
related
to
endocrine
disruption.
Based
on
available
data,
no
endocrine
system­
related
effects
have
been
identified
with
consumption
of
1­
MCP.
In
addition,
1­
MCP
does
not
share
any
structural
similarity
to
any
known
endocrine
disruptive
chemical.

B.
Analytical
Method(
s)

EPA
is
establishing
an
exemption
from
the
requirement
of
a
tolerance
without
any
numerical
limitation
for
the
reasons
stated
above,
including
1­
MCP's
lack
of
mammalian
toxicity.
For
the
same
reasons,
the
Agency
has
concluded
that
an
analytical
method
is
not
required
for
enforcement
purposes
for
1­
MCP.

C.
Codex
Maximum
Residue
Level
No
Codex
maximum
residue
levels
are
established
for
residues
of
1­
MCP
in
or
on
any
food
or
feed
crop.
There
are
no
established
tolerances
or
exemptions
from
tolerance
for
1­
MCP
in
the
United
States.
The
Agency
has
classified
1­
MCP
as
a
biochemical
pesticide.

VIII.
Conclusions
Based
on
the
toxicology
data
submitted,
there
is
reasonable
certainty
no
harm
will
result
from
aggregate
exposure
of
residues
of
1­
MCP
to
the
U.
S.
population,
including
infants
and
children,
when
the
proposed
product
is
used
in
accordance
with
label
instructions
and
good
agricultural
practices.
This
includes
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
reliable
data
were
submitted,
accepted
and
reviewed.
The
Agency
has
arrived
at
this
conclusion
based
on
the
data
submitted
demonstrating
no
toxicity
at
the
maximum
doses
tested.
As
a
result,
EPA
establishes
an
exemption
from
tolerance
requirements
pursuant
to
FFDCA
408(
c)
and
(
d)
for
residues
of
1­
MCP
in
or
on
all
food
commodities.

IX.
Objections
and
Hearing
Requests
Under
section
408(
g)
of
the
FFDCA,
as
amended
by
the
FQPA,
any
person
may
file
an
objection
to
any
aspect
of
this
regulation
and
may
also
request
a
hearing
on
those
objections.
The
EPA
procedural
regulations
which
govern
the
submission
of
objections
and
requests
for
hearings
appear
in
40
CFR
part
178.
Although
the
procedures
in
those
regulations
require
some
modification
to
reflect
the
amendments
made
to
the
FFDCA
by
the
FQPA
of
1996,
EPA
will
continue
to
use
those
procedures,
with
appropriate
adjustments,
until
the
necessary
modifications
can
be
made.
The
new
section
408(
g)
provides
essentially
the
same
process
for
persons
to
``
object''
to
a
regulation
for
an
exemption
from
the
requirement
of
a
tolerance
issued
by
EPA
under
new
section
408(
d),
as
was
provided
in
the
old
FFDCA
sections
408
and
409.
However,
the
period
for
filing
objections
is
now
60
days,
rather
than
30
days.

A.
What
Do
I
Need
to
Do
to
File
an
Objection
or
Request
a
Hearing?
You
must
file
your
objection
or
request
a
hearing
on
this
regulation
in
accordance
with
the
instructions
provided
in
this
unit
and
in
40
CFR
part
178.
To
ensure
proper
receipt
by
EPA,
you
must
identify
docket
ID
number
OPP
 
2002
 
0142
in
the
subject
line
on
the
first
page
of
your
submission.
All
requests
must
be
in
writing,
and
must
be
mailed
or
delivered
to
the
Hearing
Clerk
on
or
before
September
24,
2002.
1.
Filing
the
request.
Your
objection
must
specify
the
specific
provisions
in
the
regulation
that
you
object
to,
and
the
grounds
for
the
objections
(
40
CFR
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/
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July
26,
2002
/
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and
Regulations
178.25).
If
a
hearing
is
requested,
the
objections
must
include
a
statement
of
the
factual
issues(
s)
on
which
a
hearing
is
requested,
the
requestor's
contentions
on
such
issues,
and
a
summary
of
any
evidence
relied
upon
by
the
objector
(
40
CFR
178.27).
Information
submitted
in
connection
with
an
objection
or
hearing
request
may
be
claimed
confidential
by
marking
any
part
or
all
of
that
information
as
CBI.
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
A
copy
of
the
information
that
does
not
contain
CBI
must
be
submitted
for
inclusion
in
the
public
record.
Information
not
marked
confidential
may
be
disclosed
publicly
by
EPA
without
prior
notice.
Mail
your
written
request
to:
Office
of
the
Hearing
Clerk
(
1900),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
You
may
also
deliver
your
request
to
the
Office
of
the
Hearing
Clerk
in
Rm.
C400,
Waterside
Mall,
401
M
St.,
SW.,
Washington,
DC
20460.
The
Office
of
the
Hearing
Clerk
is
open
from
8
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Office
of
the
Hearing
Clerk
is
(
202)
260
 
4865.
2.
Tolerance
fee
payment.
If
you
file
an
objection
or
request
a
hearing,
you
must
also
pay
the
fee
prescribed
by
40
CFR
180.33(
i)
or
request
a
waiver
of
that
fee
pursuant
to
40
CFR
180.33(
m).
You
must
mail
the
fee
to:
EPA
Headquarters
Accounting
Operations
Branch,
Office
of
Pesticide
Programs,
P.
O.
Box
360277M,
Pittsburgh,
PA
15251.
Please
identify
the
fee
submission
by
labeling
it
``
Tolerance
Petition
Fees.''
EPA
is
authorized
to
waive
any
fee
requirement
``
when
in
the
judgement
of
the
Administrator
such
a
waiver
or
refund
is
equitable
and
not
contrary
to
the
purpose
of
this
subsection.''
For
additional
information
regarding
the
waiver
of
these
fees,
you
may
contact
James
Tompkins
by
phone
at
(
703)
305
 
5697,
by
e­
mail
at
tompkins.
jim@
epa.
gov,
or
by
mailing
a
request
for
information
to
Mr.
Tompkins
at
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
If
you
would
like
to
request
a
waiver
of
the
tolerance
objection
fees,
you
must
mail
your
request
for
such
a
waiver
to:
James
Hollins,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
3.
Copies
for
the
Docket.
In
addition
to
filing
an
objection
or
hearing
request
with
the
Hearing
Clerk
as
described
in
Unit
IX.
A.,
you
should
also
send
a
copy
of
your
request
to
the
PIRIB
for
its
inclusion
in
the
official
record
that
is
described
in
Unit
I.
B.
2.
Mail
your
copies,
identified
by
docket
ID
number
OPP
 
2002
 
0142,
to:
Public
Information
and
Records
Integrity
Branch,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
In
person
or
by
courier,
bring
a
copy
to
the
location
of
the
PIRIB
described
in
Unit
I.
B.
2.
You
may
also
send
an
electronic
copy
of
your
request
via
e­
mail
to:
oppdocket
epa.
gov.
Please
use
an
ASCII
file
format
and
avoid
the
use
of
special
characters
and
any
form
of
encryption.
Copies
of
electronic
objections
and
hearing
requests
will
also
be
accepted
on
disks
in
WordPerfect
6.1/
8.0
or
ASCII
file
format.
Do
not
include
any
CBI
in
your
electronic
copy.
You
may
also
submit
an
electronic
copy
of
your
request
at
many
Federal
Depository
Libraries.

B.
When
Will
the
Agency
Grant
a
Request
for
a
Hearing?
A
request
for
a
hearing
will
be
granted
if
the
Administrator
determines
that
the
material
submitted
shows
the
following:
There
is
a
genuine
and
substantial
issue
of
fact;
there
is
a
reasonable
possibility
that
available
evidence
identified
by
the
requestor
would,
if
established
resolve
one
or
more
of
such
issues
in
favor
of
the
requestor,
taking
into
account
uncontested
claims
or
facts
to
the
contrary;
and
resolution
of
the
factual
issues(
s)
in
the
manner
sought
by
the
requestor
would
be
adequate
to
justify
the
action
requested
(
40
CFR
178.32).

X.
Regulatory
Assessment
Requirements
This
final
rule
establishes
an
exemption
from
the
tolerance
requirement
under
FFDCA
section
408(
d)
in
response
to
a
petition
submitted
to
the
Agency.
The
Office
of
Management
and
Budget
(
OMB)
has
exempted
these
types
of
actions
from
review
under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993).
Because
this
rule
has
been
exempted
from
review
under
Executive
Order
12866
due
to
its
lack
of
significance,
this
rule
is
not
subject
to
Executive
Order
13211,
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
(
66
FR
28355,
May
22,
2001).
This
final
rule
does
not
contain
any
information
collections
subject
to
OMB
approval
under
the
Paperwork
Reduction
Act
(
PRA),
44
U.
S.
C.
3501
et
seq.,
or
impose
any
enforceable
duty
or
contain
any
unfunded
mandate
as
described
under
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
UMRA)
(
Public
Law
104
 
4).
Nor
does
it
require
any
special
considerations
under
Executive
Order
12898,
entitled
Federal
Actions
to
Address
Environmental
Justice
in
Minority
Populations
and
Low­
Income
Populations
(
59
FR
7629,
February
16,
1994);
or
OMB
review
or
any
Agency
action
under
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997).
This
action
does
not
involve
any
technical
standards
that
would
require
Agency
consideration
of
voluntary
consensus
standards
pursuant
to
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
NTTAA),
Public
Law
104
 
113,
section
12(
d)
(
15
U.
S.
C.
272
note).
Since
tolerances
and
exemptions
that
are
established
on
the
basis
of
a
petition
under
FFDCA
section
408(
d),
such
as
the
tolerance
exemption
in
this
final
rule,
do
not
require
the
issuance
of
a
proposed
rule,
the
requirements
of
the
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et
seq.)
do
not
apply.
In
addition,
the
Agency
has
determined
that
this
action
will
not
have
a
substantial
direct
effect
on
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government,
as
specified
in
Executive
Order
13132,
entitled
Federalism
(
64
FR
43255,
August
10,
1999).
Executive
Order
13132
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
State
and
local
officials
in
the
development
of
regulatory
policies
that
have
federalism
implications.''
``
Policies
that
have
federalism
implications''
is
defined
in
the
Executive
order
to
include
regulations
that
have
``
substantial
direct
effects
on
the
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government.''
This
final
rule
directly
regulates
growers,
food
processors,
food
handlers
and
food
retailers,
not
States.
This
action
does
not
alter
the
relationships
or
distribution
of
power
and
responsibilities
established
by
Congress
in
the
preemption
provisions
of
FFDCA
section
408(
n)(
4).
For
these
same
reasons,
the
Agency
has
determined
that
this
rule
does
not
have
any
``
tribal
implications
''
as
described
in
Executive
Order
13175,
entitled
Consultation
and
Coordination
with
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Federal
Register
/
Vol.
67,
No.
144
/
Friday,
July
26,
2002
/
Rules
and
Regulations
Indian
Tribal
Governments
(
65
FR
67249,
November
6,
2000).
Executive
Order
13175,
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
tribal
officials
in
the
development
of
regulatory
policies
that
have
tribal
implications.''
``
Policies
that
have
tribal
implications''
is
defined
in
the
Executive
order
to
include
regulations
that
have
``
substantial
direct
effects
on
one
or
more
Indian
tribes,
on
the
relationship
between
the
Federal
Government
and
the
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes.''
This
rule
will
not
have
substantial
direct
effects
on
tribal
governments,
on
the
relationship
between
the
Federal
Government
and
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
government
and
Indian
tribes,
as
specified
in
Executive
Order
13175.
Thus,
Executive
Order
13175
does
not
apply
to
this
rule.

XI.
Submission
to
Congress
and
the
Comptroller
General
The
Congressional
Review
Act,
5
U.
S.
C.
801
et
seq.,
as
added
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996,
generally
provides
that
before
a
rule
may
take
effect,
the
agency
promulgating
the
rule
must
submit
a
rule
report,
which
includes
a
copy
of
the
rule,
to
each
House
of
the
Congress
and
to
the
Comptroller
General
of
the
United
States.
EPA
will
submit
a
report
containing
this
rule
and
other
required
information
to
the
U.
S.
Senate,
the
U.
S.
House
of
Representatives,
and
the
Comptroller
General
of
the
United
States
prior
to
publication
of
this
final
rule
in
the
Federal
Register.
This
final
rule
is
not
a
``
major
rule''
as
defined
by
5
U.
S.
C.
804(
2).

List
of
Subjects
in
40
CFR
Part
180
Environmental
protection,
Administrative
practice
and
procedure,
Agricultural
commodities,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.

Dated:
July
16,
2002.
Marcia
E.
Mulkey,
Director,
Office
of
Pesticide
Programs.

Therefore,
40
CFR
chapter
I
is
amended
as
follows:

PART
180
 
[
AMENDED]

1.
The
authority
citation
for
part
180
continues
to
read
as
follows:

Authority:
21
U.
S.
C.
321(
q),
346(
a)
and
374.
2.
Section
180.1220
is
added
to
subpart
D
to
read
as
follows:

§
180.1220
1­
Methylcyclopropene;
exemption
from
the
requirement
of
a
tolerance.

An
exemption
from
the
requirement
of
a
tolerance
is
established
for
residues
of
1­
Methylcyclopropene
in
or
on
fruits
and
vegetables
when
used
as
a
post
harvest
plant
growth
regulator,
i.
e.,
for
the
purpose
of
inhibiting
the
effects
of
ethylene.
[
FR
Doc.
02
 
18868
Filed
7
 
25
 
02;
8:
45am]

BILLING
CODE
6560
 
50
 
S
DEPARTMENT
OF
HEALTH
AND
HUMAN
SERVICES
Centers
for
Medicare
&
Medicaid
Services
42
CFR
Part
405
[
CMS
 
3074
 
F2]

RIN
0938
 
AK98
Medicare
Program;
End­
Stage
Renal
Disease:
Removing
of
Waiver
of
Conditions
for
Coverage
Under
a
State
of
Emergency
in
the
Houston,
Texas
Area
AGENCY:
Centers
for
Medicare
&
Medicaid
Services
(
CMS).
ACTION:
Final
rule.

SUMMARY:
This
final
rule
removes
an
emergency
waiver
of
the
Medicare
endstage
renal
disease
(
ESRD)
conditions
for
coverage
granted
to
permit
the
transplant
team
of
an
approved
renal
transplant
center
to
furnish
kidney
transplant
services
in
three
specific
hospitals
in
the
Houston,
Texas
area
during
a
state
of
emergency.
The
state
of
emergency
has
ceased,
the
primary
kidney
transplant
center
in
the
area
is
now
fully
operational,
and
the
effective
period
of
the
waiver
provisions
has
expired.

EFFECTIVE
DATE:
July
26,
2002.
FOR
FURTHER
INFORMATION
CONTACT:
Rachael
Weinstein,
(
410)
786
 
6775
SUPPLEMENTARY
INFORMATION
I.
Provisions
of
This
Rule
On
June
20,
2001,
we
published
a
final
rule
in
the
Federal
Register
(
66
FR
33030
 
33031)
that
granted
an
emergency
waiver
of
the
Medicare
endstage
renal
disease
(
ESRD)
conditions
of
coverage
to
permit
the
transplant
team
of
an
approved
renal
transplant
center
to
furnish
covered
kidney
transplant
services
in
three
specific
hospitals
in
the
Houston,
Texas
area
during
a
state
of
emergency.
The
state
of
emergency
(
a
natural
disaster
due
to
flooding)
resulted
in
a
severe
health
and
safety
threat
to
hospitals
in
the
entire
Houston,
Texas
area,
including
ESRD
facilities
that
were
approved
to
furnish
kidney
transplant
services.
Waivers
of
the
conditions
of
coverage
were
granted
to
Memorial
Hermann­
Memorial
City
Hospital,
Memorial
Hermann
Southwest
Hospital,
and
Memorial
Hermann
Southeast
Hospital
to
permit
an
approved
transplant
team
to
furnish
kidney
transplant
services
in
the
three
hospitals,
effective
June
15,
2001,
through
the
earlier
of
December
15,
2001,
or
until
Memorial
Hermann
Hospital,
the
primary
kidney
transplant
center,
reopened.
Memorial
Hermann
Hospital
is
now
reopened.
In
the
June
20,
2001
final
rule,
we
amended
the
Medicare
regulations
to
include
a
new
§
405.2175
that
incorporated
the
waiver
provisions.
In
§
405.2175,
we
specified
that
we
would
publish
a
rule
removing
the
waiver
provisions
from
the
regulations
after
the
waiver
expired.
The
waiver
has
expired
and
we
are
removing
the
provisions
from
the
Medicare
regulations.

II.
Waiver
of
Proposed
Rulemaking
and
Delay
of
Effective
Date
We
ordinarily
publish
a
notice
of
proposed
rulemaking
in
the
Federal
Register
and
invite
public
comment
on
a
proposed
rule.
The
notice
of
proposed
rulemaking
includes
a
reference
to
the
legal
authority
under
which
the
rule
is
proposed,
and
the
terms
and
substances
of
the
proposed
rule
or
a
description
of
the
subjects
and
issues
involved.
This
procedure
can
be
waived,
however,
if
an
agency
finds
good
cause
that
a
noticeand
comment
procedure
is
impracticable,
unnecessary,
or
contrary
to
the
public
interest
and
incorporates
a
statement
of
the
findings
and
its
reasons
in
the
rule
issued.
Further,
we
generally
provide
for
final
rules
to
be
effective
no
sooner
than
30
days
after
the
date
of
publication
unless
we
find
good
cause
under
5
U.
S.
C.
553(
d)(
3)
to
waive
the
30­
day
delay
of
the
effective
date.
The
purpose
of
the
30­
day
waiting
period
between
publication
of
an
administrative
agency
final
rule
and
its
effective
date
is
to
give
affected
parties
reasonable
time
to
adjust
their
behavior
before
the
final
rule
takes
place.
The
state
of
emergency
under
which
we
granted
a
waiver
of
the
ESRD
conditions
of
coverage
is
now
over
in
the
Houston,
Texas
area,
and
Memorial
Hermann
Hospital
is
reopened
to
furnish
kidney
transplant
services.
We
announced
in
the
June
20,
2001
final
rule
our
intention
to
remove
the
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