Document ID: EPA-HQ-OPP-2002-0273-0001
Agency: epa
Document Type: Rule
Title: Pelargonic Acid (Nonanoic Acid); Exemption from the Requirement of a Pesticide Tolerance
Posted Date: 2003-02-19T05:00Z

7931
Federal
Register
/
Vol.
68,
No.
33
/
Wednesday,
February
19,
2003
/
Rules
and
Regulations
Dated:
February
4,
2003.
Craig
E.
Bone,
Captain,
Coast
Guard
Captain
of
the
Port,
New
York.
[
FR
Doc.
03
 
3980
Filed
2
 
18
 
03;
8:
45
am]

BILLING
CODE
4910
 
15
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2002
 
0273;
FRL
 
7278
 
7]

Pelargonic
Acid
(
Nonanoic
Acid);
Exemption
from
the
Requirement
of
a
Pesticide
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
the
pelargonic
acid
in
or
on
all
foods
when
applied
used
as
a
component
of
a
food
contact
surface
sanitizing
solution
in
food
handling
establishments.
Eco
Lab
Inc.
requested
this
tolerance
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
DATES:
This
regulation
is
effective
February
19,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2002
 
0273,
must
be
received
on
or
before
April
21,
2003.
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
VI.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Adam
Heyward,
Antimicrobials
Division
(
7510C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
6422;
e­
mail
address:
heyward.
adam@
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:
 
Crop
production
(
NAIC
code
111)
 
Animal
production
(
NAIC
code
112)
 
Food
manufacturing
(
NAIC
code
311)
 
Pesticide
manufacturing
(
NAIC
code
32532)

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
 
2002
 
0273.
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
In
the
Federal
Register
of
December
7,
2001
(
66
FR
63534)
(
FRL
 
6737
 
9),
EPA
issued
a
notice
pursuant
to
section
408
of
FFDCA,
21
U.
S.
C.
346a,
as
amended
by
FQPA
(
Public
Law
104
 
170),
announcing
the
filing
of
a
pesticide
petition
(
PP
0F6193)
by
Eco
Lab
Inc.,
370
N.
Wabasha
Street,
St.
Paul
MN
55102.
That
notice
included
a
summary
of
the
petition
prepared
by
Eco
Lab,
Inc.,
the
registrant.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petition
requested
that
40
CFR
180.1159
be
amended
by
establishing
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
nonanoic
acid.
Nonanoic
acid
is
a
component
of
a
proposed
product
KX­
6116
in
which
this
active
ingredient
is
present
at
6.49%
in
the
formulation.
The
proposed
sanitizer
formulation
is
applied
to
food
contact
surfaces
such
as
equipment,
pipelines,
tanks,
vats,
fillers,
evaporators,
pasteurizers
and
aseptic
equipment
in
restaurants,
food
service
operations,
dairies,
breweries,
wineries,
and
beverage
and
food
processing
plants.
The
sanitizer
is
applied
by
immersion,
coarse
spray,
or
circulation
technique
as
appropriate
to
the
equipment.
The
solution,
once
applied,
is
allowed
to
drain
and
dry
and
there
is
no
potable
water
rinse.
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
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.
.
.
.''
EPA
performs
a
number
of
analyses
to
determine
the
risks
from
aggregate
exposure
to
pesticide
residues.
First,
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
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Federal
Register
/
Vol.
68,
No.
33
/
Wednesday,
February
19,
2003
/
Rules
and
Regulations
variability
of
the
sensitivities
of
major
identifiable
subgroups
of
consumers,
including
infants
and
children.
The
nature
of
the
toxic
effects
caused
by
pelargonic
acid
(
nonanoic
acid)
are
discussed
in
this
unit.

A.
Acute
Toxicity
As
a
result
of
a
number
of
acute
toxicity
studies,
technical
pelargonic
acid
is
placed
in
the
following
Toxicity
Categories:
Primary
eye
irritation
(
Toxicity
Category
II),
primary
eye
irritation
(
Toxicity
Category
II),
acute
oral
toxicity
(
Toxicity
Category
IV),
acute
dermal
and
inhalation
toxicity
(
Toxicity
Category
III).
Sensitization
test
results
showed
that
pelargonic
acid
cannot
be
considered
a
dermal
sensitizer.

B.
Subchronic
and
Chronic
Toxicity
In
an
oral
toxicity
study
(
conducted
for
14­
days),
no
systemic
toxicity
was
observed
with
either
sex
even
at
the
highest
dose
tested,
20,000
parts
per
million
(
ppm)
(
1,834
milligrams/
kilogram/
day
(
mg/
kg/
day)).
In
addition,
pelargonic
acid
showed
no
adverse
effects
on
survival,
clinical
signs,
body
weight
gain,
food
consumption,
hematology,
clinical
chemistry
or
gross
pathology.
For
each
dose,
three
animals
per
sex
were
tested.
However,
the
study
did
not
report
organ
weights
and
histopathology.
This
was
considered
a
deficiency
in
this
study.
Nevertheless,
the
Agency
determined
that
because
no
toxic
effects
were
observed
at
a
very
high
level
of
 
2,000
mg/
kg,
a
90
 
day
oral
study
was
not
necessary.
A
28
 
day
dermal
toxicity
study
conducted
on
rabbits
was
submitted
to
the
Agency
under
TSCA
section
8(
e).
Five
male
and
five
female
New
Zealand
white
rabbits
were
dermally
treated
with
pelargonic
acid
present
in
mineral
oil.
In
all,
10
applications
were
made
(
5
per
week)
at
a
dose
level
of
500
mg/
kg/
day.
A
2
 
week
recovery
period
was
allowed
for
selected
rabbits.
During
the
first
and
second
week
of
treatment,
slight
body
weight
loss
and
decreased
food
consumption
were
observed.
One
female
rabbit
showed
ocular
discharge
and
hypoactivity
during
the
second
week
of
treatment.
All
rabbits
dermally
treated
with
pelargonic
acid
by
day
14
showed
signs
of
severe
erythema
and
moderate
edema.
Dermal
reactions
consisting
of
moderate
desquamation,
moderate
fissuring,
eschar,
exfoliation
and
necrosis
were
also
observed
at
day
14.
By
day
29,
all
dermal
reactions
had
reversed.
It
was
evident
that
at
the
treatment
level
of
500
mg/
kg/
day
of
pelargonic
acid,
significant
dermal
signs
of
toxicity
were
observed
but
no
significant
systemic
reaction.
A
supplemental
study
on
chronic
toxicity/
carcinogenicity
in
mice
was
conducted
for
80
weeks.
A
dose
of
50
mg
of
pelargonic
acid
was
dermally
applied
to
each
mouse
twice/
day
for
80
weeks.
Histopathology
showed
no
nonneoplastic
or
neoplastic
lesions
on
skins
and
internal
organs
of
mice.
The
Agency
concluded
that
this
study
although
not
exactly
conducted
according
to
guideline,
adequately
assesses
the
chronic
toxicity
and
the
carcinogenic
potential
of
pelargonic
acid
via
the
dermal
route.

C.
Developmental
Toxicity
A
development
toxicity
was
conducted
on
a
group
of
22
pregnant
Crl:
COBS
CD(
SD)
BR
rats.
These
rats
were
treated
with
pelargonic
acid
in
corn
oil
at
a
dose
of
1,500
mg/
kg
on
gestation
days
6
through
15
(
both
days
inclusive).
Maternal
body
weight
was
not
significantly
affected
during
the
treatment.
Only
1
out
of
22
animals
showed
signs
of
clinical
toxicity.
No
significant
histopathology
signs
were
observed
in
the
maternal
animals.
Pelargonic
acid
treatment
did
not
have
any
significant
effect
on
cesarean
section
observations.
Four
fetuses
in
one
litter
showed
a
higher
incidence
of
cleft
palate
compared
to
the
control
mean.
For
maternal
toxicity,
the
Agency
has
determined
the
no
observed
adverse
effect
level
(
NOAEL)
to
be
greater
than
1,500
mg/
kg/
day.
Because
fetal
effects
were
observed
at
1,500
mg/
kg/
day,
the
NOAEL
for
developmental
toxicity
was
not
determined.
The
Agency
has
determined
that
this
dose
is
in
excess
of
the
Agency's
limit
dose
for
toxic
effects.
The
type
and
level
of
exposure
expected
from
the
use
of
this
chemical
is
much
lower
than
the
dose
level
shown
in
the
study.

D.
Mutagenicity/
Carcinogenicity
Ames
Test
(
Salmonella/
reverse
mutation
assay)
showed
pelargonic
acid
to
be
non­
mutgenic.
Similarly,
in
vivo
cytogenetics
study
using
micronucleus
assay
gave
a
negative
result.
In
a
mouse
lymphoma
forward
mutation
study,
pelargonic
acid
appears
to
induce
a
weak
mutagenic
response
at
or
higher
than
50
milligrams/
milliliter
(
mg/
mL)
level.
This
was
observed
in
the
presence
of
increasing
toxicity,
and
may
be
an
indication
of
gross
chromosomal
changes
or
damage
and
not
actual
mutational
changes
within
the
thymidine
kinese
gene
locus.
As
described
above,
a
summary
of
the
results
of
a
dermal
carcinogenicity
study
in
mice
with
pelargonic
acid
was
submitted.
Fifty
mice
were
treated
twice­
weekly
with
50
mg
doses
of
undiluted
pelargonic
acid
for
80
weeks.
No
evidence
of
severe
dermal
or
systemic
toxicity
was
seen.
Histopathology
revealed
no
tumors
of
the
skin
or
the
internal
organs
E.
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).
The
Agency
has
considered
available
information
on
the
aggregate
exposure
levels
of
consumers
(
and
major
identifiable
subgroups
of
consumers)
to
the
pesticide
chemical
residue
of
pelargonic
acid
(
nonanoic
acid)
and
to
other
related
substances.
In
these
considerations,
the
Agency
has
included
dietary
exposure
under
the
tolerance
exemption
and
all
other
tolerances
or
exemptions
in
effect
for
pelargonic
acid's
chemical
residue
and
exposure
from
non­
occupational
sources.
The
Food
and
Drug
Administration
has
cleared
pelargonic
acid
as
a
synthetic
food
flavoring
agent
(
21
CFR
172.515),
as
an
adjuvant,
production
aid
and
sanitizer
to
be
used
in
contact
with
food
(
21
CFR
178.1010(
b))
and
in
washing
or
to
assist
in
lye
peeling
of
fruits
and
vegetables
(
up
to
1%)
(
21
CFR
173.315).
Pelargonic
acid
is
also
exempt
from
the
requirement
of
a
tolerance
when
used
in
or
on
all
food
commodities,
as
a
plant
regulator
on
plants,
seeds,
or
cuttings
after
harvest
in
accordance
with
GAP.
It
is
also
exempt
from
a
tolerance
when
used
as
a
herbicide
on
all
plant
food
commodities
provided
that
allocations
are
not
made
directly
to
the
food
commodity
except
when
used
as
a
harvest
aid
or
dessicant
to
any
root
or
tuber
vegetable,
bulb,
or
cotton
(
40
CFR
180.1159).
Applications
of
the
proposed
end­
use
products
containing
pelargonic
acid
will
not
directly
contact
edible
portions
of
food
commodities.
1.
Food.
For
the
proposed
sanitizer
uses,
a
worst
case
dietary
exposure
estimate
has
been
calculated,
assuming
that
all
food
consumed
by
an
adult
or
child
has
contacted
a
sanitized
surface
using
pelargonic
acid,
that
a
1
mg/
cm2
sanitizer
residue
remains
on
the
surface,
and
that
100%
of
the
residue
(
170
ppm)
is
transferred
to
the
food
from
the
surface.
Using
these
assumptions,
in
which
all
food
contacts
4,000
cm2
of
sanitized
non­
porous
food­
contact
surfaces
a
worst
case
dietary
exposure
of
680
µ
g/
day
is
calculated.
For
a
70
kg
adult
this
becomes
9.7
µ
g/
kg/
day
and
for
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a
15
kg
child,
exposure
is
calculated
as
45
µ
g/
kg/
day.
2.
Drinking
water
exposure.
KX­
6116
as
a
sanitizer
contains
pelargonic
acid
as
its
active
component
and
low
concentrations
of
pelargonic
acid
could
be
expected
to
be
introduced
into
drinking
water.
However,
exposure
through
drinking
water
is
expected
to
be
low
and
not
of
significance.
3.
Other
non­
occupational
exposure.
Based
on
the
intended
use
of
pelargonic
acid
in
food
handling
establishments,
exposure
to
pelargonic
acid
as
a
component
of
KX­
6116
sanitizer
through
non­
occupational,
non­
dietary
sources
is
not
likely
to
occur.
4.
Cumulative
effects.
Section
408(
b)(
2)(
D)(
v)
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.
Based
on
the
information
discussed
in
Unit
VII.
EPA
concluded
that
pelargonic
acid
is
sufficiently
non­
toxic
that
EPA
can
determine
that
it
does
not
share
a
common
mechanism
of
toxicity
with
other
substances.

F.
Safety
Factor
for
Infants
and
Children
Section
408
of
the
FFDCA
provides
that
EPA
shall
apply
an
additional
tenfold
margin
of
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
on
toxicity
and
exposure
unless
EPA
determines
that
a
different
margin
of
safety
will
be
safe
for
infants
and
children.
Margins
of
safety
are
incorporated
into
EPA
risk
assessments
either
directly
through
use
of
a
MOE
analysis
or
through
using
uncertainty
(
safety)
factors
in
calculating
a
dose
level
that
poses
no
appreciable
risk
to
humans.
Based
on
the
considerations
discussed
in
Unit
III.
G.,
EPA
concluded
that
pelargonic
acid
was
sufficiently
nontoxic
that
a
margin
of
safety
analysis
was
not
appropriate.
For
the
same
reason,
EPA
has
not
applied
an
additional
margin
of
safety
for
the
protection
of
infants
and
children.

G.
Determination
of
Safety
Based
on
the
following
considerations,
EPA
concludes
that
pelargonic
acid
is
unlikely
to
pose
a
risk
under
all
reasonable
exposure
scenarios:
1.
Fatty
acids
such
as
pelargonic
acid
are
processed
by
known
metabolic
pathways
within
the
body
and
contribute
to
normal
physiological
function.
2.
Pelargonic
acid
is
naturally
present
at
levels
up
to
224
parts
per
billion
(
ppb)
in
apples,
385
ppm
in
the
skin
of
grapes,
and
143
ppm
in
grape
pulp.
It
is
present
in
a
number
of
other
foods
as
well.
An
average
serving
of
grapes
containing
385
ppm
of
pelargonic
acid
in
the
grape
skins
would
result
in
exposure
to
pelargonic
acid
to
an
average
consumer
of
164
µ
g/
kg/
day.
In
comparison,
a
worst
case
estimate
of
dietary
exposure
to
pelargonic
acid
as
a
result
of
its
use
as
sanitizer
is
9.7
µ
g/
kg/
day
for
a
70
kg
adult
and
45
µ
g/
kg/
day
for
a
15
kg
child.
3.
The
Food
and
Drug
Administration
has
cleared
pelargonic
acid
as
a
synthetic
food
flavoring
agent
(
21
CFR
172.515),
as
an
adjuvant,
production
aid
and
sanitizer
to
be
used
in
contact
with
food
(
21
CFR
178.1010(
b))
and
in
washing
or
to
assist
in
lye
peeling
of
fruits
and
vegetables
(
up
to
1%)
(
21
CFR
173.315).
Pelargonic
acid
is
also
exempt
from
the
requirement
of
a
tolerance
when
used
in
or
on
all
food
commodities,
as
a
plant
regulator
on
plants,
seeds,
or
cuttings
after
harvest
in
accordance
with
Good
Agricultural
Practices
(
GAP).
It
is
also
exempt
from
a
tolerance
when
used
as
a
herbicide
on
all
plant
food
commodities
provided
that
allocations
are
not
made
directly
to
the
food
commodity
except
when
used
as
a
harvest
aid
or
dessicant
to
any
root
or
tuber
vegetable,
bulb,
or
cotton
(
40
CFR
180.1159).
4.
Dietary
toxicity
testing
evidenced
adverse
reactions
only
at
doses
that
were
at
or
above
limit
doses.
Dermal
toxicity
testing
showed
no
significant
systemic
reaction.
5.
The
estimated
exposures
to
pelargonic
acid
and
other
fatty
acids
from
direct
or
indirect
addition
to
food
as
well
as
sanitizer
uses
are
well
below
the
doses
administered
in
animal
studies
that
are
required
to
elicit
an
adverse
effect.
Accordingly,
EPA
concludes
that
there
is
a
reasonable
certainty
of
no
harm
to
the
general
population,
including
infants
and
children,
from
aggregate
exposure
to
pelargonic
acid.

IV.
Other
Considerations
A.
Analytical
Method(
s)

Because
an
exemption
from
the
requirement
of
a
tolerance
without
numerical
limitation
for
residues
in
food
is
being
granted
for
pelargonic
acid,
an
enforcement
analytical
method
is
not
needed.
However,
an
analytical
method
is
available
in
cases
of
gross
misuse.
The
analytical
method
is
being
made
available
to
anyone
interested
in
pesticide
enforcement
when
requested,
from
Norm
Cook,
Antimicrobials
Division
(
7510C),
Office
of
Pesticide
Programs,
U.
S.
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
Office
location
and
telephone
number:
1921
Jefferson
Davis
Highway,
3rd
Floor,
Arlington,
VA
22202,
(
703)
308
 
8253.

B.
Existing
Tolerances
1.
40
CFR
180.1159.
Pelargonic
acid
is
exempted
from
the
requirement
of
a
tolerance
on
all
food
commodities
when
used
as
a
plant
regulator
on
plants,
seeds,
or
cuttings
and
all
food
commodities
after
harvest
in
accordance
with
GAP
or
as
a
herbicide
when
applications
are
not
made
directly
to
the
food
commodity
except
when
used
as
a
harvest
aid
or
dessicant
to:
any
root
and
tuber
vegetables,
bulb
vegetable
or
cotton.
When
pelargonic
acid
is
used
as
a
harvest
aid
or
dessicant,
application
must
be
made
no
later
than
24
hours
prior
to
harvest.
2.
21
CFR
178.1010(
c)(
37).
Pelargonic
acid
is
permitted
in
food
contact
sanitizing
solutions
at
a
level
up
to
90
ppm.
3.
21
CFR
172.515.
Pelargonic
acid
may
be
safely
used
as
synthetic
food
flavoring
substances
and
adjuvants
in
food
in
the
minimum
quantity
required
to
reproduce
the
intended
effect.
4.
21
CFR
173.315.
Pelargonic
acid
may
be
used
in
an
aliphatic
acid
mixture
for
washing
or
to
assist
in
the
peeling
of
fruits
and
vegetables.
The
aliphatic
acid
mixture
may
be
used
at
a
level
not
to
exceed
1%
in
the
lye
peeling
solution.

C.
International
Tolerances
No
codex
maximum
residue
levels
have
been
established
for
the
pelargonic
acid.

V.
Conclusion
An
exemption
from
the
requirement
of
a
tolerance
is
established
for
residues
of
pelargonic
acid
in
or
on
all
raw
agricultural
commodities
and
in
processed
commodities,
when
such
residues
result
from
the
use
of
pelargonic
acid
as
an
antimicrobial
treatment
in
solutions
containing
a
diluted
end­
use
concentration
of
pelargonic
acid
up
to
170
ppm
per
application
on
food
contact
surfaces
such
as
equipment,
pipelines,
tanks,
vats,
fillers,
evaporators,
pasteurizers
and
aseptic
equipment
in
restaurants,
food
service
operations,
dairies,
breweries,
wineries,
beverage
and
food
processing
plants.
The
sanitizer
shall
be
applied
by
immersion,
coarse
spay,
or
circulation
technique
as
appropriate
to
the
equipment
or
utensil.
No
potable
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water
rinse
is
required
following
the
use
of
the
sanitizer.

VI.
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
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
 
2002
 
0273
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
April
21,
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.
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
VI.
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
docket
ID
number
OPP
 
2002
 
0273,
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:
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).

VII.
Statutory
and
Executive
Order
Reviews
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
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Federal
Register
/
Vol.
68,
No.
33
/
Wednesday,
February
19,
2003
/
Rules
and
Regulations
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
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
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.

VIII.
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:
January
21,
2003.
James
Jones,
Acting
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
180.1159
is
amended
by
adding
paragraph
(
c)
to
read
as
follows:

§
180.1159
Pelargonic
acid;
exemption
from
the
requirement
of
a
tolerance.

*
*
*
*
*
(
c)
An
exemption
from
the
requirement
of
a
tolerance
is
established
for
residues
of
pelargonic
acid
in
or
on
all
raw
agricultural
commodities
and
in
processed
commodities,
when
such
residues
result
from
the
use
of
pelargonic
acid
as
an
antimicrobial
treatment
in
solutions
containing
a
diluted
end­
use
concentration
of
pelargonic
acid
up
to
170
ppm
per
application
on
food
contact
surfaces
such
as
equipment,
pipelines,
tanks,
vats,
fillers,
evaporators,
pasteurizers
and
aseptic
equipment
in
restaurants,
food
service
operations,
dairies,
breweries,
wineries,
beverage
and
food
processing
plants.

[
FR
Doc.
03
 
3842
Filed
2
 
18
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2002
 
0272;
FRL
 
7278
 
6]

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

SUMMARY:
This
regulation
establishes
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
decanoic
acid
(
capric
acid)
in
or
on
all
foods
when
applied/
used
as
a
component
of
a
food
contact
surface
sanitizing
solution
in
food
handling
establishments.
Eco
Lab
Inc.
submitted
a
petition
to
EPA
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA),
requesting
an
exemption
from
the
requirement
of
a
tolerance.
This
regulation
eliminates
the
need
to
establish
a
maximum
permissible
level
for
residues
of
decanoic
acid.
DATES:
This
regulation
is
effective
February
19,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2002
 
0272,
must
be
received
on
or
before
April
21,
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
X.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Adam
Heyward,
Antimicrobials
Division
(
7510C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
6422;
email
address:
heyward.
adam@
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:
 
Crop
production
(
NAIC
code
111)
 
Animal
production
(
NAIC
code
112)

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