Document ID: EPA-HQ-OPP-2003-0002-0001
Agency: epa
Document Type: Notice
Title: Thymol and Eucalyptus Oil; Exemptions from the Requirement  of a Tolerance
Posted Date: 2003-06-06T04:00Z

33876
Federal
Register
/
Vol.
68,
No.
109
/
Friday,
June
6,
2003
/
Rules
and
Regulations
DATES:
This
withdrawal
of
the
direct
final
action
is
made
as
of
June
6,
2003.
FOR
FURTHER
INFORMATION
CONTACT:
Jeffrey
S.
Butensky,
Environmental
Planner,
(
617)
918
 
1665;
butensky.
jeff@
epa.
gov.

List
of
Subjects
in
40
CFR
Part
52
Environmental
protection,
Air
pollution
control,
Intergovernmental
relations,
Particulate
matter,
Reporting
and
recordkeeping
requirements.

Dated:
May
28,
2003.
Ira
W.
Leighton,
Acting
Regional
Administrator,
EPA
New
England.
[
FR
Doc.
03
 
14189
Filed
6
 
5
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0002;
FRL
 
7308
 
1]

Thymol
and
Eucalyptus
Oil;
Exemptions
from
the
Requirement
of
a
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
time­
limited
exemptions
from
the
requirement
of
a
tolerance
for
residues
of
thymol
and
eucalyptus
oil
on
honey
and
honeycomb.
This
action
is
in
response
to
EPA's
granting
of
an
emergency
exemption
under
section
18
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
authorizing
use
of
these
pesticides
in
beehives.
This
regulation
eliminates
the
need
to
establish
a
maximum
permissible
level
for
residues
of
thymol
and
eucalyptus
oil
in
or
on
honey
and
honeycomb.
These
time­
limited
exemptions
from
the
requirement
of
a
tolerance
for
residues
of
the
thymol
and
eucalyptus
oil
will
expire
and
are
revoked
on
June
30,
2005.
DATES:
This
regulation
is
effective
June
6,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0002,
must
be
received
on
or
before
August
5,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
VII.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Barbara
Madden,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
6463;
e­
mail
address:
madden.
barbara@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?
You
may
be
potentially
affected
by
this
action
if
you
are
a
Federal
or
State
government
agency
involved
in
administration
of
environmental
quality
programs.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Federal
or
State
Government
Entity,
(
NAICS
9241),
i.
e.,
Departments
of
Agriculture,
Environment,
etc.
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
this
unit
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
If
you
have
any
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
Copies
of
this
Document
and
Other
Related
Information?
1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP
 
2003
 
0002.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
This
docket
facility
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
docket
telephone
number
is
(
703)
305
 
5805.
2.
Electronic
access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
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,
a
beta
site
currently
under
development.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
1.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.

II.
Background
and
Statutory
Findings
EPA,
on
its
own
initiative,
in
accordance
with
sections
408(
e)
and
408(
l)(
6)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a,
is
establishing
time­
limited
exemptions
from
the
requirement
of
a
tolerance
for
residues
of
thymol
and
eucalyptus
oil
in
or
on
honey
and
honeycomb.
These
time­
limited
exemptions
from
the
requirement
of
a
tolerance
for
residues
of
the
thymol
and
eucalyptus
oil
will
expire
and
are
revoked
on
June
30,
2005.
EPA
will
publish
a
document
in
the
Federal
Register
to
remove
the
revoked
exemptions
from
the
Code
of
Federal
Regulations.
Section
408(
l)(
6)
of
the
FFDCA
requires
EPA
to
establish
a
time­
limited
tolerance
or
exemption
from
the
requirement
for
a
tolerance
for
pesticide
chemical
residues
in
food
that
will
result
from
the
use
of
a
pesticide
under
an
emergency
exemption
granted
by
EPA
under
section
18
of
FIFRA.
Such
tolerances
can
be
established
without
providing
notice
or
period
for
public
comment.
EPA
does
not
intend
for
its
actions
on
section
18
related
tolerances
to
set
binding
precedents
for
the
application
of
section
408
of
the
FFDCA
and
the
new
safety
standard
to
other
tolerances
and
exemptions.
Section
408(
e)
of
the
FFDCA
allows
EPA
to
establish
a
tolerance
or
an
exemption
from
the
requirement
of
a
tolerance
on
its
own
initiative,
i.
e.,
without
having
received
any
petition
from
an
outside
party.
Section
408(
b)(
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(
b)(
2)(
A)(
ii)
defines
``
safe''
to
mean
that
``
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
pesticide
VerDate
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Federal
Register
/
Vol.
68,
No.
109
/
Friday,
June
6,
2003
/
Rules
and
Regulations
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....''
Section
18
of
the
FIFRA
authorizes
EPA
to
exempt
any
Federal
or
State
agency
from
any
provision
of
FIFRA,
if
EPA
determines
that
``
emergency
conditions
exist
which
require
such
exemption.''
This
provision
was
not
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
EPA
has
established
regulations
governing
such
emergency
exemptions
in
40
CFR
part
166.

III.
Emergency
Exemption
for
Thymol
and
Eucalyptus
Oil
on
Honey
and
Honeycomb
and
FFDCA
Tolerances
The
varroa
mite
is
an
ectoparasite
of
honey
bees.
It
was
first
detected
in
the
continental
United
States
in
Maryland
in
1979,
and
found
in
Florida
and
Wisconsin
by
1987.
Currently,
it
is
the
most
important
pest
of
honey
bee
colonies.
The
mites
feed
on
the
hemolymph
of
the
developing
bee
larva,
pupa,
and
adult
bees.
Dead
or
dying
newly
emerged
bees
have
malformed
wings,
legs,
abdomens,
and
thoraces.
Recent
anecdotal
evidence
suggests
that
bee
viruses
and
varroa
mites
are
closely
linked.
The
mites
have
been
shown
to
activate
some
of
these
viruses;
causing
virus
outbreaks
that
ultimately
lead
to
colony
mortality.
Fluvalinate
is
currently
registered
for
the
control
of
varroa
mites;
however,
populations
of
varroa
mites
have
developed
resistance
to
fluvalinate.
Varroa
mite
resistance
to
fluvalinate
has
been
well
documented
by
the
United
States
Department
of
Agriculture
(
USDA),
Agricultural
Research
Service
(
ARS).
According
to
USDA,
ARS
many
hives
treated
with
fluvalinate
have
resulted
in
wholesale
colony
losses.
Due
to
the
destructive
nature
of
this
pest
coupled
with
the
importance
of
honey
bees
(
for
honey
production
and
pollination
of
numerous
agricultural
crops)
to
the
U.
S.
economy,
it
is
imperative
that
alternative
means
of
controlling
the
varroa
mite
be
developed.
The
Agency
has
authorized
the
use
of
coumaphos
in
beehives
to
control
varroa
mites
under
section
18
of
FIFRA
since
1999
in
up
to
46
states.
During
the
2001
use
season
there
were
limited
reports
of
mites
resistant
to
coumaphos
in
Maine
and
Florida.
Resistance
to
coumaphos
in
Florida
was
confirmed
by
the
USDA's
Texas
Bee
Lab
in
December
of
2001.
In
Maine,
bees
are
primarily
imported
during
the
growing
season
from
Florida.
South
Carolina
has
indicated
that
the
beekeeping
industry
is
migratory
in
nature,
especially
in
the
coastal
region
of
the
state
and
subject
to
the
introduction
of
coumaphos
resistant
mites
from
Florida.
Therefore,
the
states
have
requested
use
of
the
unregistered
product
ApiLife
VAR,
containing
thymol
and
eucalyptus
oil
to
control
mites
resistant
to
coumaphos.
EPA
has
authorized
under
FIFRA
section
18
the
use
of
thymol
and
eucalyptus
oil
in
beehives
for
control
of
varroa
mites
in
Maine,
Minnesota,
Mississippi,
Utah,
Indiana,
and
South
Carolina.
After
having
reviewed
the
submission,
EPA
concurs
that
emergency
conditions
exist
for
these
States.
As
part
of
its
assessment
of
this
emergency
exemption,
EPA
assessed
the
potential
risks
presented
by
residues
of
thymol
and
eucalyptus
oil
in
or
on
honey
and
honeycomb.
In
doing
so,
EPA
considered
the
safety
standard
in
section
408(
b)(
2)
of
the
FFDCA,
and
EPA
decided
that
the
necessary
exemptions
from
the
requirement
of
a
tolerance
under
section
408(
l)(
6)
of
the
FFDCA
would
be
consistent
with
the
safety
standard
and
with
FIFRA
section
18.
Consistent
with
the
need
to
move
quickly
on
the
emergency
exemption
in
order
to
address
an
urgent
non­
routine
situation
and
to
ensure
that
the
resulting
food
is
safe
and
lawful,
EPA
is
issuing
these
exemptions
without
notice
and
opportunity
for
public
comment
as
provided
in
section
408(
l)(
6)
of
the
FFDCA.
Although
these
exemptions
from
the
requirement
of
a
tolerance
will
expire
and
are
revoked
on
June
30,
2005,
under
section
408(
l)(
5)
of
the
FFDCA,
residues
of
the
pesticide
in
the
tolerance
remaining
in
or
on
honey
and
honeycomb
after
that
date
will
not
be
unlawful,
provided
the
pesticide
is
applied
in
a
manner
that
was
lawful
under
FIFRA.
EPA
will
take
action
to
revoke
these
exemptions
earlier
if
any
experience
with,
scientific
data
on,
or
other
relevant
information
on
these
pesticides
indicate
that
the
residues
are
not
safe.
Because
these
exemptions
from
the
requirement
of
a
tolerance
are
being
approved
under
emergency
conditions,
EPA
has
not
made
any
decisions
about
whether
thymol
and
eucalyptus
oil
meets
EPA's
registration
requirements
for
use
on
honey
and
honeycomb
or
whether
permanent
exemptions
for
this
use
would
be
appropriate.
Under
these
circumstances,
EPA
does
not
believe
that
these
exemptions
from
the
requirement
of
a
tolerance
serve
as
a
basis
for
registrations
of
thymol
and
eucalyptus
oil
by
a
State
for
special
local
needs
under
FIFRA
section
24(
c).
Nor
do
these
exemptions
serve
as
the
basis
for
any
State
other
than
Maine
and
South
Carolina
to
use
these
pesticides
in
beehives
under
section
18
of
FIFRA
without
following
all
provisions
of
EPA's
regulations
implementing
FIFRA
section
18
as
identified
in
40
CFR
part
166.
For
additional
information
regarding
the
emergency
exemptions
for
thymol
and
eucalyptus
oil,
contact
the
Agency's
Registration
Division
at
the
address
provided
under
FOR
FURTHER
INFORMATION
CONTACT.

IV.
Aggregate
Risk
Assessment
and
Determination
of
Safety
for
Thymol
EPA
performs
a
number
of
analyses
to
determine
the
risks
from
aggregate
exposure
to
pesticide
residues.
For
further
discussion
of
the
regulatory
requirements
of
section
408
of
the
FFDCA
and
a
complete
description
of
the
risk
assessment
process,
see
the
final
rule
on
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997)
(
FRL
 
5754
 
7).
Consistent
with
section
408(
b)(
2)(
D)
of
the
FFDCA,
EPA
has
reviewed
the
available
scientific
data
and
other
relevant
information
in
support
of
this
action.
EPA
has
sufficient
data
to
assess
the
hazards
of
thymol
and
to
make
a
determination
on
aggregate
exposure,
consistent
with
section
408(
b)(
2)
of
the
FFDCA,
for
exemptions
from
the
requirement
of
a
tolerance
for
residues
of
thymol
in
or
on
honey
and
honeycomb.
EPA's
assessment
of
the
dietary
exposures
and
risks
associated
with
establishing
these
exemptions
from
the
requirement
of
a
tolerance
follows.

A.
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
nature
of
the
toxic
effects
caused
by
thymol
is
discussed
in
this
unit.
The
EPA
has
not
received
nor
does
it
have
available
any
guideline
studies
on
the
mammalian
toxicity
of
thymol.
Thymol
is
found
naturally
occurring
in
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Vol.
68,
No.
109
/
Friday,
June
6,
2003
/
Rules
and
Regulations
thyme
herb
(
e.
g.,
Thymus
vulgaris,
T.
zygis).
Thyme
herb
is
used
as
a
food
seasoning
ingredient,
and
is
generally
recognized
as
a
safe
(
GRAS)
natural
seasoning
by
the
Food
and
Drug
Administration
(
FDA)
(
21
CFR
182.10).
Thyme
oil
also
is
recognized
as
a
GRAS
essential
oil
by
FDA
(
21
CFR
182.20).
In
September
of
1993,
the
EPA
issued
a
Reregistration
Eligibility
Decision
(
RED)
for
thymol.
At
that
time
the
Agency
concluded
that
thymol
is
an
active
ingredient
that
should
be
considered
for
a
broad
waiver
of
generic
data
requirements.
This
conclusion
was
based
on
the
following
information:
Thymol
is
a
component
of
many
nonpesticidal
consumer
products
currently
marketed
in
the
United
States.
Thymol
is
listed
as
a
food
additive
by
the
Food
and
Drug
Administration
(
21
CFR
172.515;
synthetic
flavoring
substances
and
adjuvants).
Thymol
is
rapidly
degraded
in
the
environment
to
elemental
constituents
by
normal
biological,
physical,
and/
or
chemical
processes
that
can
be
reasonably
expected
to
exist
where
the
pesticide
is
applied....
The
phenols
of
thymol
are
considered
GRAS
as
set
forth
in
21
CFR
172.515
(
synthetic
flavoring
substances
and
adjuvants)....
Thymol
toxicity
data
reported
available
literature
cite
acute
oral
LD50
values
as
980
milligrams/
kilogram
(
mg/
kg)
and
880
mg/
kg
for
the
rat
and
guinea
pig,
respectively
(
Sax,
1984).
The
acute
oral
toxicity
reported
for
the
rat
and
guinea
pig,
respectively
corresponds
to
Toxicity
Category
III.
The
Material
Safety
Data
Sheet
(
MSDS)
for
the
manufacture
of
technical
grade
thymol
cites
human
health
effects
as
irritating
when
exposed
by
inhalation,
dermal
or
eye
contact.
The
MSDS
also
estimates
a
human
ingestion
LD50
at
2
grams
of
the
synthetic
thymol.
Based
upon
an
estimated
thymol
dermal
toxicity
LD50
of
greater
than
2,000
mg/
kg,
the
dermal
toxicity
would
be
Toxicity
Category
III.
(
Refer
to
pages
6
and
7
of
the
RED)
A
summary
of
the
submitted
information
on
thymol
toxicity
allows
for
the
statements
that
the
acute
oral
LD50
in
the
rat
is
980
mg/
kg
and
in
the
mouse
is
640
to
1,800
mg/
kg.
Thymol
is
corrosive
to
the
rabbit
eye
and
skin,
and
is
not
reported
as
a
dermal
sensitizer
in
the
guinea
pig.
Thymol
is
readily
absorbed
from
the
gastrointestinal
tract
and
is
essentially
excreted
in
the
urine
as
a
glucuronate
and
sulfate
conjugate
of
the
parent
compound.
Dosing
of
rats
with
thymol
in
the
feed
at
667
mg/
kg
body
weight/
day
(
highest
dose
tested)
for
19
weeks
did
not
produce
any
harmful
effects.
Thymol
is
not
mutagenic
in
Salmonella,
but
gives
statistically
significant
positive
results
in
an
Unscheduled
DNA
synthesis
and
Sister
Chromatid
Exchange
tests,
and
in
a
cell
transformation
test
with
Syrian
hamster
embryonic
cells.
Multiple
malformations
are
noted
when
thymol
is
injected
into
the
air
bubble
or
yolk
sac
of
embryonic
chickens.

B.
Exposure
Assessment
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).
1.
Dietary
exposure
 
i.
Food.
Thymol
is
found
naturally
occurring
in
thyme
herb
(
e.
g.,
Thymus
vulgaris,
T.
zygis).
Thyme
herb
is
used
as
a
food
seasoning
ingredient,
and
is
generally
recognized
as
a
safe
(
GRAS)
natural
seasoning
by
FDA
(
21
CFR
182.10).
Thyme
oil
also
is
recognized
as
a
GRAS
essential
oil
by
FDA
(
21
CFR
182.20).
The
volatile
oil
component
of
thyme
herb
is
about
2%
to
5%
content,
and
thyme
oil
is
reported
to
contain
from
30%
to
75%
thymol,
and
even
up
to
90%.
Thymol
may
be
safely
used
in
foods
as
a
synthetic
flavoring
substance
when
used
in
the
minimum
quantity
to
produce
the
intended
effect
(
21
CFR
172.515).
Levels
of
thymol
reported
in
foods
where
it
is
permitted
as
a
direct
food
additive
have
been
stated
as
44
ppm
in
ice
cream,
ices,
etc.;
2.5
ppm
to
11
ppm
in
nonalcoholic
beverages;
9.4
ppm
in
candy,
5
ppm
to
6.5
ppm
in
baked
goods,
and
100
ppm
in
chewing
gum.
Thymol
is
a
natural
component
of
lime
blossom
honey,
where
the
maximum
thymol
content
has
been
determined
to
be
0.16
mg/
kg.
Studies
in
Europe
showed
that
when
ApiLife
Var
was
used
for
8
weeks
in
the
autumn
over
1
to
5
years
the
maximum
thymol
residue
observed
was
0.48
mg/
kg.
The
average
(
median)
residue
value
for
thymol
was
0.16
mg/
kg
in
honey.
When
export
and
import
tonnage
values
of
honey
are
taken
into
consideration
with
U.
S.
honey
production,
the
average
yearly
per
capita
intake
of
honey
is
about
2
pounds,
roughly
equivalent
to
1
kg.
If
all
the
honey
contained
0.5
mg/
kg
thymol
then
the
per
capita
intake
of
thymol
would
be
about
1.4
µ
g/
day.
For
a
60
kg
adult
the
chronic
exposure
value
is
about
0.022
µ
g/
kg
body
weight/
day.
If
a
60
kg
adult
consumed
1
kg
of
honey
containing
0.5
mg
thymol
in
90
days
the
subchronic
dietary
exposure
to
thymol
would
be
about
2
µ
g/
kg
body
weight/
day.
Even
if
all
2
kg
of
the
thymolcontaining
honey
were
consumed
in
one
sitting,
the
acute
exposure
to
thymol
still
would
be
as
low
as
83
µ
g.
2.
Drinking
water
exposure.
No
drinking
water
exposure
is
expected
from
the
pesticidal
use
of
thymol
which
is
confined
to
placement
in
beehives.
Thymol
is
currently
registered
for
use
on
ornamental
plants,
shrubs
and
grasses
so
there
is
some
potential
for
exposure
to
water.
However,
thymol
is
a
constituent
of
a
mixture
of
organic
compounds
known
to
be
rapidly
degraded
in
the
environment
to
elemental
compounds
by
normal
biological,
physical
and/
or
chemical
processes.
In
the
RED,
the
Agency
concluded
that
the
registered
uses
of
thymol
will
result
in
negligible
exposure
of
the
environment
and
nontarget
organisms
(
refer
to
page
7
of
the
RED).
Therefore,
thymol
is
not
expected
to
be
found
in
drinking
water.
3.
Other
non­
occupational
exposure.
The
potential
for
non­
dietary
exposure
to
thymol
residues
for
the
general
population,
including
infants
and
children,
is
unlikely
because
the
proposed
use
site
is
limited
to
beehives.
Thymol
is
a
normal
constituent
of
the
human
diet,
as
a
component
of
thyme
and
thyme
oil,
and
as
a
direct
food
additive.
Therefore,
while
there
exists
a
great
likelihood
of
prior
exposure
for
most,
if
not
all
individuals
to
thymol,
any
increased
exposure
due
to
the
proposed
use
would
be
negligible.
Thyme,
which
contains
thymol,
is
a
pesticide
active
ingredient
for
the
control
of
aphids
on
ornamental
plants.
Thyme
and
thyme
oil
are
considered
minimum
risk
pesticides,
and
are
exempted
as
active
ingredients
under
FIFRA
[
40
CFR
152.25(
g)].
4.
Cumulative
exposure
to
substances
with
a
common
mechanism
of
toxicity.
Section
408(
b)(
2)(
D)(
v)
of
the
FFDCA
requires
that,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
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
does
not
have,
at
this
time,
available
data
to
determine
whether
thymol
has
a
common
mechanism
of
toxicity
with
other
substances
or
how
to
include
this
pesticide
in
a
cumulative
risk
assessment.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
thymol
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
For
the
purposes
of
this
exemption
from
the
requirement
of
a
tolerance,
therefore,
EPA
has
not
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Vol.
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109
/
Friday,
June
6,
2003
/
Rules
and
Regulations
assumed
that
thymol
has
a
common
mechanism
of
toxicity
with
other
substances.
For
information
regarding
EPA's
efforts
to
determine
which
chemicals
have
a
common
mechanism
of
toxicity
and
to
evaluate
the
cumulative
effects
of
such
chemicals,
see
the
final
rule
for
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997).

C.
Aggregate
Risks
and
Determination
of
Safety
for
U.
S.
Population,
Infants
and
Children
The
dietary
exposure
to
residues
of
thymol
to
the
U.
S.
population
from
use
of
ApiLife
Var
is
not
likely
to
add
significantly
to
current
dietary
exposure
to
thymol.
For
instance,
thymol
has
been
measured
in
chewing
gum
at
100
mg/
kg,
in
candy
at
9.4
mg/
kg,
and
in
ice
cream
at
44
mg/
kg.
These
values
respectively
are
200
 
,
20
 
,
and
100
 
fold
greater
than
the
highest
level
of
thymol
(
i.
e.,
0.48
mg/
kg)
measured
in
honey
treated
with
ApiLife
Var.
In
addition,
thymol
as
measured
in
ice
cream
is
about
300
 
fold
higher
than
the
average
residue
level
of
thymol
(
i.
e.,
0.16
mg/
kg)
in
hives
treated
with
ApiLife
Var.
Additionally,
it
is
typical
for
language
to
appear
on
labels
of
honey
that
states
``
Do
not
feed
to
infants
under
1
year,''
so
there
likely
would
be
no
exposure
of
this
population
to
residues
of
thymol
in
the
honey.
Older
children
likely
have
been
exposed
to
thymol
residues
from
consumption
of
candy,
ice
cream,
and
baked
goods.
Consumption
of
honey
from
hives
treated
with
ApiLife
Var
is
unlikely
to
significantly
increase
exposure
to
thymol.
Therefore,
based
on
the
long
history
of
use
of
thyme,
thyme
oil,
and
thymol
in
the
diet
with
no
known
adverse
effects,
it
is
reasonable
to
conclude
that
no
harm
will
result
from
exposure
to
thymol
in
honey
from
beehives
treated
with
ApiLife
Var.
Accordingly,
EPA
finds
that
exempting
thymol
from
the
requirement
of
a
tolerance
will
be
safe.

V.
Aggregate
Risk
Assessment
and
Determination
of
Safety
for
Eucalyptus
Oil
Consistent
with
section
408(
b)(
2)(
D)
of
the
FFDCA,
EPA
has
reviewed
the
available
scientific
data
and
other
relevant
information
in
support
of
this
action.
EPA
has
sufficient
data
to
assess
the
hazards
of
eucalyptus
oil
and
to
make
a
determination
on
aggregate
exposure,
consistent
with
section
408(
b)(
2)
of
the
FFDCA,
for
exemptions
from
the
requirement
of
a
tolerance
for
residues
of
eucalyptus
oil
in
or
on
honey
and
honeycomb.
EPA's
assessment
of
the
dietary
exposures
and
risks
associated
with
establishing
these
exemptions
from
the
requirement
of
a
tolerance
follows.

A.
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
nature
of
the
toxic
effects
caused
by
eucalyptus
oil
is
discussed
in
this
unit.
The
EPA
has
not
received
nor
does
it
have
available
any
guideline
studies
on
the
mammalian
toxicity
of
eucalyptus
oil.
Eucalyptus
oil
is
obtained
from
steam
distillation
of
the
leaves
of
Eucalyptus
globulus
and,
in
addition
to
cineole,
contains
triterpenes,
monoterpenes,
sesquiterpenes,
aldehydes
and
ketones.
Information
submitted
by
the
applicant
allows
for
the
statements
that
acute
oral
LD50
value
for
eucalyptus
oil
in
rats
is
2,480
mg/
kg.
Eucalyptol
(
1,8­
cineole)
which
makes
up
70%
or
more
of
eucalyptus
oil
may
be
safely
used
in
foods
as
a
synthetic
flavoring
substance
when
used
in
the
minimum
quantity
to
produce
the
intended
effect
(
21
CFR
172.515).
Eucalyptus
globulus
leaves
also
may
safely
be
used
in
foods
(
21
CFR
172.510).

B.
Exposure
Assessment
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).
1.
Dietary
exposure.
 
i.
Food.
Eucalyptus
oil
is
obtained
from
steam
distillation
of
the
leaves
of
Eucalyptus
globulus
and,
in
addition
to
cineole,
contains
triterpenes,
monoterpenes,
sesquiterpenes,
aldehydes
and
ketones.
Levels
of
eucalyptus
oil
reported
in
foods
where
it
is
permitted
as
a
direct
food
additive
have
been
stated
as
0.5
to
50
ppm
in
ice
cream,
ices
etc.;
1.7
ppm
in
non­
alcoholic
beverages;
1.0
ppm
in
alcoholic
beverages;
130
ppm
in
candy;
and
76
ppm
in
baked
goods.
Cineole
in
foods
has
been
reported
at
0.13
ppm
in
non­
alcoholic
beverages;
0.50
ppm
in
ice
cream,
ices,
etc.;
15
ppm
in
candy;
0.5
to
4.0
ppm
in
baked
goods,
and
190
ppm
in
chewing
gum.
Studies
in
Europe
showed
that
when
ApiLife
Var
was
used
for
8
weeks
in
the
autumn
over
1
to
5
years,
residues
of
eucalyptus
oil
(
measured
as
1,8­
cineole)
were
less
than
the
limit
of
detection,
i.
e.,
<
0.01
ppm.
ii.
Drinking
water
exposure.
No
drinking
water
exposure
is
expected
from
the
pesticidal
use
of
eucalyptus
oil
which
is
confined
to
placement
in
beehives.
Further,
there
are
no
products
registered
that
will
result
in
exposure
to
drinking
water.
Therefore,
eucalyptus
oil
is
not
expected
to
found
in
drinking
water.
2.
Other
non­
occupational
exposure.
The
potential
for
non­
dietary
exposure
to
eucalyptus
oil
residues
for
the
general
population,
including
infants
and
children,
is
unlikely
because
the
proposed
use­
site
is
limited
to
beehives.
Eucalyptus
oil
is
a
constituent
of
the
human
diet
as
a
direct
food
additive.
Eucalyptus
oil
is
used
as
a
component
of
decongestant
products,
as
an
expectorant
component
of
cough
and
cold
products,
in
various
oral
dosage
forms
(
e.
g.,
lozenges
and
syrups),
and
as
an
inhalant
in
vapor
baths.
It
is
used
in
dermally
applied
products
for
burns,
blisters,
and
for
muscle
and
joint
aches.
It
may
be
a
component
of
toothpaste,
soaps,
detergents
and
toiletries.
It
is
reported
to
be
used
internally
at
0.3
to
0.6
grams/
day,
and
externally
at
5%
to
20%
in
paraffin,
jelly,
or
vegetable
oil
bases.
Oil
of
eucalyptus
has
antimicrobial
properties,
and
has
been
registered
as
an
active
pesticide
ingredient
in
an
herbal
flea
collar
pet
product
(
active
ingredient
is
in
the
product
at
1.00%).
3.
Cumulative
exposure
to
substances
with
a
common
mechanism
of
toxicity.
Section
408(
b)(
2)(
D)(
v)
of
the
FFDCA
requires
that,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
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
does
not
have,
at
this
time,
available
data
to
determine
whether
eucalyptus
oil
has
a
common
mechanism
of
toxicity
with
other
substances
or
how
to
include
this
pesticide
in
a
cumulative
risk
assessment.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
eucalyptus
oil
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
For
the
purposes
of
this
exemption
from
the
requirement
of
a
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tolerance,
therefore,
EPA
has
not
assumed
that
eucalyptus
oil
has
a
common
mechanism
of
toxicity
with
other
substances.
For
information
regarding
EPA's
efforts
to
determine
which
chemicals
have
a
common
mechanism
of
toxicity
and
to
evaluate
the
cumulative
effects
of
such
chemicals,
see
the
final
rule
for
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997).

C.
Aggregate
Risks
and
Determination
of
Safety
for
U.
S.
Population,
Infants
and
Children
The
dietary
exposure
to
residues
of
eucalyptus
oil
to
the
U.
S.
population
from
use
of
ApiLife
Var
is
not
likely
to
add
significantly
to
current
dietary
exposure
to
eucalyptus
oil.
This
is
because
no
residues
of
eucalyptus
oil
were
detectable
(
i.
e.,
<
0.01
ppm;
measured
as
1,8­
cineole)
when
ApiLife
was
used
in
hives
in
the
autumn
in
Europe
for
up
to
5
years.
Even
if
oil
of
eucalyptus
residues
were
found
in
honey
from
hives
treated
with
Apilife
Var,
they
would
have
to
be
present
at
5,000
times
greater
than
the
limit
of
detection
to
reach
the
level
reported
in
ice
cream
(
i.
e.,
50
mg/
kg)
and
170
times
greater
than
the
limit
of
detection
to
reach
the
level
reported
in
nonalcoholic
beverages
(
i.
e.,
1.7
mg/
kg).
Therefore,
based
on
the
long
history
of
use
of
eucalyptus
oil
in
the
diet
with
no
known
adverse
effect,
coupled
with
the
expectation
of
no
to
minimal
residues
from
use
of
ApiLife
Var
in
hives,
it
is
reasonable
to
conclude
that
no
harm
will
result
from
this
pesticidal
use.
Accordingly,
EPA
finds
that
exempting
eucalyptus
oil
from
the
requirement
of
a
tolerance
will
be
safe.

VI.
Other
Considerations
A.
Analytical
Enforcement
Methodology
The
Agency
has
not
reviewed
the
method,
nor
its
accuracy
or
reliability,
used
to
previously
analyze
thymol
and
eucalyptus
oil
residues
in
honey;
nor
has
it
confirmed
that
prior
use
of
ApiLife
Var
in
European
hives
will
give
equivalent
residues
in
hives
in
the
United
States.
However,
review
of
information
submitted
on
a
gas
chromatographic
method
of
analysis
to
measure
thymol
and
eucalyptus
oil
in
European
hives,
and
the
similarity
of
the
European
hives
to
U.
S.
hives
allow
for
the
conclusion
that
thymol
and
eucalyptus
oil
residues
in
honey
from
these
hives
will
not
be
significantly
greater,
provided
ApiLife
Var
is
applied
at
the
same
rates
to
overwintering
hives
in
the
United
States
as
was
done
previously
in
Europe.
The
method
may
be
requested
from:
Barbara
Madden,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:(
703)
305
 
6463;
e­
mail
address:
madden.
barbara@
epa.
gov.

B.
International
Residue
Limits
No
Codex
Maximum
Residue
Levels
(
MRL)
are
established
for
thymol.
However,
Switzerland
has
established
an
MRL
of
0.8
mg/
kg,
apparently
not
from
a
safety
finding,
but
rather
arising
from
legislation
that
prohibits
foreign
odors
or
tastes
in
honey.
According
to
the
World
Health
Organization,
thymol
residues
in
food
are
safe
to
consumers
at
up
to
50
mg/
kg.
According
to
European
Union
regulation
Nr.
2377/
90,
thymol
is
in
group
II
of
the
non­
toxic
veterinary
drugs
which
do
not
require
a
MRL.
No
Codex
Maximum
Residue
Levels
(
MRL)
are
established
for
eucalyptus
oil.

VII.
Conclusion
Therefore,
time­
limited
exemptions
from
the
requirement
of
a
tolerance
are
established
for
residues
of
thymol
and
eucalyptus
oil
in
or
on
honey
and
honeycomb.

VIII.
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,
EPA
will
continue
to
use
those
procedures,
with
appropriate
adjustments,
until
the
necessary
modifications
can
be
made.
The
new
section
408(
g)
of
the
FFDCA
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)
of
the
FFDCA,
as
was
provided
in
the
old
sections
408
and
409
of
the
FFDCA.
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
 
2003
 
0002
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
August
5,
2003.
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
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
(
1900C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
You
may
also
deliver
your
request
to
the
Office
of
the
Hearing
Clerk
in
Rm.
104,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
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
(
703)
603
 
0061.
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
 
0001.

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/
Rules
and
Regulations
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
 
0001.
3.
Copies
for
the
Docket.
In
addition
to
filing
an
objection
or
hearing
request
with
the
Hearing
Clerk
as
described
in
Unit
VII.
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.
1.
Mail
your
copies,
identified
by
the
docket
ID
number
OPP
 
2003
 
0002,
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
 
0001.
In
person
or
by
courier,
bring
a
copy
to
the
location
of
the
PIRIB
described
in
Unit
I.
B.
1.
You
may
also
send
an
electronic
copy
of
your
request
via
e­
mail
to:
opp­
docket@
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).

IX.
Statutory
and
Executive
Order
Reviews
This
final
rule
establishes
a
timelimited
exemption
from
the
tolerance
requirement
under
section
408
of
the
FFDCA.
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
FIFRA
section
18
exemption
under
section
408
of
the
FFDCA,
such
as
the
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
section
408(
n)(
4)
of
the
FFDCA.
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
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.

X.
Congressional
Review
Act
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.

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Federal
Register
/
Vol.
68,
No.
109
/
Friday,
June
6,
2003
/
Rules
and
Regulations
Dated:
May
23,
2003.
James
Jones,
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
371.


2.
Section
180.1240
is
added
to
subpart
D
to
read
as
follows:

§
180.1240
Thymol;
exemption
from
the
requirement
of
a
tolerance.

Time­
limited
exemptions
from
the
requirement
of
a
tolerance
are
established
for
residues
of
thymol
in
or
on
honey
and
honeycomb
in
connection
with
use
of
the
pesticide
under
section
18
emergency
exemptions
granted
by
the
EPA.
These
time­
limited
exemptions
from
the
requirement
of
a
tolerance
for
residues
of
the
thymol
will
expire
and
are
revoked
on
June
30,
2005.


3.
Section
180.1241
is
added
to
subpart
D
to
read
as
follows:
§
180.1241
Eucalyptus
oil;
exemption
from
the
requirement
of
a
tolerance.
Time­
limited
exemptions
from
the
requirement
of
a
tolerance
are
established
for
residues
of
eucalyptus
oil
in
or
on
honey
and
honeycomb
in
connection
with
use
of
the
pesticide
under
section
18
emergency
exemptions
granted
by
the
EPA.
These
time­
limited
exemptions
from
the
requirement
of
a
tolerance
for
residues
of
the
eucalyptus
oil
will
expire
and
are
revoked
on
June
30,
2005.
[
FR
Doc.
03
 
14198
Filed
6
 
5
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
DEPARTMENT
OF
COMMERCE
National
Oceanic
and
Atmospheric
Administration
50
CFR
Part
648
Fisheries
of
the
Northeastern
United
States
CFR
Correction
In
Title
50
of
the
Code
of
Federal
Regulations,
Part
600
to
End,
revised
as
of
October
1,
2002,
§
648.21
is
corrected
by
removing
paragraph
(
e)
appearing
on
page
337
and
reinstating
the
paragraph
(
e)
appearing
on
page
316
in
the
2000
edition.
The
reinstated
text
reads
as
follows:

§
648.21
Procedures
for
determining
initial
annual
amounts.

*
*
*
*
*
(
e)
Inseason
adjustments.
The
specifications
established
pursuant
to
this
section
may
be
adjusted
by
the
Regional
Administrator,
in
consultation
with
the
MAFMC,
during
the
fishing
year
by
publishing
notification
in
the
Federal
Register
stating
the
reasons
for
such
an
action
and
providing
a
30
 
day
public
comment
period.
*
*
*
*
*

[
FR
Doc.
03
 
55515
Filed
6
 
5
 
03;
8:
45
am]

BILLING
CODE
1505
 
01
 
D
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