Document ID: EPA-HQ-OPP-2003-0177-0001
Agency: epa
Document Type: Notice
Title: Acetic Acid; Notice of Filing a Pesticide Petition to Establish an Exemption from the Requirements of a Tolerance for a Certain Pesticide Chemical in or on Food
Posted Date: 2003-06-11T04:00Z

34955
Federal
Register
/
Vol.
68,
No.
112
/
Wednesday,
June
11,
2003
/
Notices
less
than
12.5%
of
the
cPAD
for
the
total
U.
S.
population
and
all
the
subpopulations.
The
greatest
exposure
occurred
in
infants
and
children.
Exposure
estimates
for
the
acute
dietary
assessment
were
well
under
100%
of
the
acute
population
adjusted
dose
(
aPAD)
at
the
99th
percentile.
The
overall
U.
S.
population
and
the
highest
exposed
subpopulation
(
infants
<
1
year)
utilized
only
5.3%
and
less
than
21%,
respectively.
ii.
Drinking
water.
There
are
no
established
maximum
contaminant
levels
or
health
advisory
levels
for
residues
of
BAS
670
H
or
its
metabolites
in
drinking
water.
A
tier
1
drinking
water
modeling
assessment
for
BAS
670
H
using
the
FIRST
model
(
for
surface
water)
and
SCI­
GROW
(
for
ground
water)
produced
estimated
maximum
concentrations
of
0.22
parts
per
billion
(
ppb)
(
chronic)
for
surface
water
and
0.20
ppb
for
ground
water.
These
estimated
concentrations
are
less
than
a
worst
case
calculated
acceptable
level
of
3.95
ppb
children
chronic
drinking
water
levels
of
concern
(
DWLOC)
for
residues
in
drinking
water
based
on
chronic
aggregate
exposure.
Therefore,
taking
into
account
all
uses
and
exposures
one
concludes,
with
reasonable
certainty
that
residues
of
BAS
670
H
in
drinking
water
will
not
result
in
unacceptable
levels
of
aggregate
human
health
risk
at
this
time.
2.
Non­
dietary
exposure.
There
are
no
registered
or
proposed
residential
uses
for
BAS
670
H.

D.
Cumulative
Effects
At
this
time,
there
is
no
available
information
to
indicate
that
BAS
670
H
or
its
metabolites
have
a
common
mechanism
of
toxicity
with
other
substances.
Therefore,
there
is
no
reason
to
include
this
pesticide
or
its
metabolites
in
a
cumulative
risk
assessment.
For
the
purposes
of
this
tolerance
action,
EPA
has
not
assumed
that
BAS
670
H
and
its
metabolites
have
a
common
mechanism
of
toxicity
with
other
substances.

E.
Safety
Determination
1.
U.
S.
population.
Aggregate
exposure
to
the
overall
U.
S.
population
utilized
only
8.7%
of
the
aPAD
and
12.7%
of
the
cPAD,
respectively.
Therefore,
no
harm
to
the
overall
U.
S.
population
would
result
from
the
use
of
BAS
670
H
on
field,
sweet,
or
pop
corn.
2.
Infants
and
children.
There
is
a
complete
toxicity
base
for
BAS
670
H
and
exposure
data
are
complete
or
are
estimated
based
on
data
that
reasonably
accounts
for
potential
exposures.
Taking
into
account
the
completeness
of
the
data
base,
BASF
Corporation
concludes
that
the
FQPA
safety
factor
should
be
retained
but
reduced
to
3X.
This
is
based
on
the
occurrence
of
kidney
malformations
in
rabbits
and
skeletal
variations
in
rabbits
and
rats,
all
occurring
at
doses,
which
caused
either
maternal
tyrosine
elevations
or
other
evidence
of
maternal
toxicity.
The
full
toxicological
data
base
that
has
been
developed
for
BAS
670
H
includes
many
additional
mechanistic
studies,
revealing
consistency
and
the
mode
of
action
of
these
effects.
The
kidney
was
a
target
organ
in
all
repeated
dose
studies
and
these
effects
were
caused
by
elevated
tyrosine
levels
due
to
inhibition
of
the
HPPD
enzyme.
Using
the
standard
worst
case
exposure
assumptions
(
residues
at
tolerance
level
and
100%
crop
treated),
aggregate
exposure
to
BAS
670
H
from
food
and
water
will
utilize
33%
and
less
than
24%
of
the
aPAD
and
cPAD,
respectively
for
infants
and
children.
EPA
generally
has
no
concern
for
exposures
below
100%
of
the
PAD
because
it
represents
the
level
at
or
below
which
daily
aggregate
exposure
over
a
lifetime
will
not
pose
appreciable
risks
to
human
health.
BASF
Corporation
concludes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
or
children
from
aggregate
exposure
to
BAS
670
H
residues
with
the
approval
of
this
tolerance
petition.

F.
International
Tolerances
No
maximum
residue
levels
(
MRLs)
have
been
established
for
BAS
670
H
by
the
CODEX
Alimentarius
Commission
or
in
Mexico.
[
FR
Doc.
03
 
14328
Filed
6
 
10
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0177;
FRL
 
7308
 
7]

Acetic
Acid;
Notice
of
Filing
a
Pesticide
Petition
to
Establish
an
Exemption
from
the
Requirements
of
a
Tolerance
for
a
Certain
Pesticide
Chemical
in
or
on
Food
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
This
notice
announces
the
initial
filing
of
a
pesticide
petition
proposing
the
establishment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities.
DATES:
Comments,
identified
by
docket
ID
number
OPP
 
2003
 
0177,
must
be
received
on
or
before
July
11,
2003.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Driss
Benmhend,
Biopesticides
and
Pollution
Prevention
Division
(
7511C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
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
potentially
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Crop
production
(
NAICS
111)
 
Animal
production
(
NAICS
112)
 
Food
manufacturing
(
NAICS
311)
 
Pesticide
manufacturing
(
NAICS
32532)
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
 
0177.
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
VerDate
Jan<
31>
2003
23:
27
Jun
10,
2003
Jkt
200001
PO
00000
Frm
00058
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
11JNN1.
SGM
11JNN1
34956
Federal
Register
/
Vol.
68,
No.
112
/
Wednesday,
June
11,
2003
/
Notices
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/.
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.
Certain
types
of
information
will
not
be
placed
in
EPA's
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
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.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.

C.
How
and
to
Whom
Do
I
Submit
Comments?
You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
not
use
EPA
Dockets
or
e­
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
email
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
or
CD
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket,
and
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select
``
search,''
and
then
key
in
docket
ID
number
OPP
 
2003
 
0177.
The
system
is
an
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e­
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
ii.
E­
mail.
Comments
may
be
sent
by
e­
mail
to
opp­
docket@
epa.
gov,
Attention:
Docket
ID
number
OPP
 
2003
 
0177.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
e­
mail
system
is
not
an
``
anonymous
access''
system.
If
you
send
an
e­
mail
comment
directly
to
the
docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e­
mail
system
automatically
captures
your
e­
mail
address.
E­
mail
addresses
that
are
automatically
captured
by
EPA's
e­
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD
ROM.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
in
Unit
I.
C.
2.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
mail.
Send
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB)
(
7502C),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001,
Attention:
Docket
ID
Number
OPP
 
2003
 
0177.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
Attention:
Docket
ID
Number
OPP
 
2003
 
0177.
Such
deliveries
are
only
accepted
during
the
docket's
normal
hours
of
operation
as
identified
in
Unit
I.
B.
1.

D.
How
Should
I
Submit
CBI
to
the
Agency?
Do
not
submit
information
that
you
consider
to
be
CBI
electronically
through
EPA's
electronic
public
docket
or
by
e­
mail.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(
if
you
submit
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
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/
Notices
CD
ROM
the
specific
information
that
is
CBI).
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?

You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
notice.
7.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
ID
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.

II.
What
Action
is
the
Agency
Taking?

EPA
has
received
a
pesticide
petition
as
follows
proposing
the
establishment
and/
or
amendment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities
under
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a.
EPA
has
determined
that
this
petition
contains
data
or
information
regarding
the
elements
set
forth
in
FFDCA
section
408(
d)(
2);
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
support
granting
of
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.
List
of
Subjects
Environmental
protection,
Agricultural
commodities,
Feed
additives,
Food
additives,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.

Dated:
May
22,
2003.
Sheryl
K.
Reilly,
Acting
Director,
Biopesticides
and
Pollution
Prevention
Division,
Office
of
Pesticide
Programs.

Summary
of
Petition
The
petitioner
summary
of
the
pesticide
petition
is
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summary
of
the
petition
was
prepared
by
the
petitioner
and
represents
the
view
of
the
petitioner.
The
petition
summary
announces
the
availability
of
a
description
of
the
analytical
methods
available
to
EPA
for
the
detection
and
measurement
of
pesticide
chemical
residues
or
an
explanation
of
why
no
such
method
is
needed.

Eastman
Chemical
Company
PP
3F6516
EPA
has
received
a
pesticide
petition
(
3F6516)
from
Eastman
Chemical
Company,
P.
O.
Box
511,
Kingsport,
TN
37662
proposing,
pursuant
to
section
408(
d)
of
the
FFDCA,
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180
to
establish
an
exemption
from
the
requirement
of
a
tolerance
for
the
biochemical
pesticide
acetic
acid.
Pursuant
to
section
408(
d)(
2)(
A)(
i)
of
the
FFDCA
as
amended,
Eastman
Chemical
Company
has
submitted
the
following
summary
of
information,
data,
and
arguments
in
support
of
their
pesticide
petition.
The
summary
of
the
petition
was
prepared
by
the
petitioner
and
represent
the
view
of
the
petitioner.
The
petition
summary
announces
the
availability
of
a
description
of
the
analytical
methods
available
to
EPA
for
the
detection
and
measurement
of
the
pesticide
chemical
residues
or
an
explanation
of
why
no
such
method
is
needed.
It
is
the
purpose
of
this
petition
to
reestablish
an
exemption
from
the
requirement
of
a
tolerance
for
acetic
acid
when
used
as
a
grain
and
hay
preservative
on
agricultural
commodities
such
as
alfalfa,
barley
grain,
Bermuda
grass,
bluegrass,
brome
grass,
clover,
corn
grain,
cowpea
hay,
fescue,
lespedeza,
lupines,
oat
grain,
orchard
grass,
peanut
grass,
Timothy,
vetch,
and
wheat
grain,
or
commodities
described
as
grain
or
hay.
Acetic
acid
is
currently
exempt
from
the
requirement
of
a
tolerance
when
used
as
a
catalyst
under
40
CFR
180.1001(
c).
Previously,
acetic
acid
was
exempt
from
the
requirement
of
a
tolerance
(
40
CFR
180.1029),
when
used
as
a
preservative
on
the
abovementioned
commodities.
This
exemption
was
canceled,
but
only
because
the
registrants
at
that
time,
did
not
wish
to
maintain
the
registration.
Subsequent
to
the
cancellation
of
the
registrations,
the
tolerance
exemption
was
revoked.

A.
Residue
Chemistry
There
have
been
no
analytical
procedures
conducted
to
ascertain
residual
acetic
acid
on
treated
commodities.
The
application
rate
for
the
preservation
of
grain
and
hay
as
per
instructions,
will
result
in
concentrations
of
about
1%
on
hay
and
about
1.5%
on
grain.
Additionally,
acetic
acid
is
generally
recognized
as
safe
(
GRAS)
under
the
Food
and
Drug
Administration
(
FDA),
40
CFR
184.1005,
for
use
in
food
when
used
in
accordance
with
good
manufacturing
or
feeding
practice.
Since
this
request
is
for
an
exemption
from
the
requirement
of
a
tolerance,
residual
acetic
acid
on
hay
and
grain
will
not
pose
a
problem
of
exposure
to
humans
or
the
environment
especially
since
acetic
acid
is
in
the
food
chain
and
is
naturally
occurring
in
nature.
Residuals
at
this
low
level
are
less
than
is
found
in
vinegar
used
on
foods.

B.
Toxicological
Profile
1.
Acute
toxicity.
Acute
oral
at
4,960
milligrams/
kilogram
body
weight
(
mg/
kg)
(
bwt)
(
Category
III).
Acute
dermal
at
1,060
mg/
kg
bwt
(
Category
II).
Acute
inhalation
at
11.4
milligrams/
Liter
(
mg/
L)
(
Category
III).
Eye
irritation,
corrosive
(
Category
I).
Dermal
irritation,
corrosive
(
Category
I).
Mild
irritant
to
guinea
pigs
at
20
mg/
24
hours.
(
Category
IV).
Contact
with
concentrated
acetic
acid
solutions
may
cause
local
damage
to
skin,
eye,
or
mucosa.
2.
Genotoxicity.
Acetic
acid
and
the
sodium
salt
of
acetic
acid,
provided
negative
results
for
mutagenicity
assays
in
strains
of
Salmonella
typhimurium.
3.
Reproductive
and
developmental
toxicity.
In
a
teratogenicity
study
by
the
Food
and
Drug
Research
Laboratories,
5%
acetic
acid
(
apple
cider
vinegar),
the
administration
of
up
to
1,600
mg/
kg
bwt,
to
pregnant
mice
for
10
consecutive
days
had
no
clear
discernible
effect
on
nidation
or
on
maternal
or
fetal
survival.
Additionally,
similar
acids
to
acetic
acid,
such
as
fumaric
acid
and
citric
acid,
illicit
no
teratogenic
or
reproductive
toxicity
in
rats
or
chick
embryos.
This
is
also
true
for
propionic
acid
(
or
salts
thereof)
which
is
used
in
the
same
manner
as
proposed
for
acetic
acid.

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Notices
4.
Subchronic
toxicity.
Waivers
have
been
requested
for
the
90
 
day
feeding,
dermal
and
inhalation
studies.
The
conditions
of
potential
exposure
requiring
these
studies
are
not
triggered.
Acetic
acid
is
a
food
acid
and
is
naturally
occurring.
Acetic
acid
is
absorbed
from
the
gastrointestinal
tract
and
through
the
lungs
and
is
readily,
although
not
completely,
oxidized
in
the
organism.
Acetic
acid
is
proposed
to
be
used
as
a
hay
and
grain
preservative
at
low
concentrations,
and
for
animal
food
only,
and
these
low
concentrations
are
lower
than
is
found
in
commercially
available
vinegar
(
5%
to
7%).
Therefore,
there
would
be
no
expected
subchronic
effects
from
the
limited
exposure
expected
to
acetic
acid,
and
the
waivers
should
be
granted.
5.
Chronic
toxicity.
Waivers
have
been
requested
for
chronic
toxicity
requirements
for
acetic
acid.
However,
the
results
of
two
Russian
studies
reported
the
induction
of
hyperplasia
in
rats
at
60
mg/
kg
bwt.
This
result
is
similar
to
induction
of
hyperplasia
in
rats
by
propionic
acid
in
a
2
 
year
study.
6.
Animal
metabolism.
Acetic
acid
is
a
food
acid
and
is
naturally
occurring.
Acetic
acid
is
utilized
as
an
energy
source
in
the
body
by
combining
first
with
Co­
enzyme
A
to
form
Acetyl­
CoA
which
then
enters
the
Kreb's
citric
acid
cycle
by
combining
with
oxaloacetate
to
yield
citrate.
This
process
is
active
in
all
animals
and
higher
plants
and
is
carried
out
in
the
mitochondria.
Acetic
acid
is
proposed
to
be
used
as
a
hay
and
grain
preservative
at
low
concentrations,
and
for
animal
food
only.
There
are
no
expected
adverse
effects.
7.
Metabolite
toxicity.
Acetic
acid
is
a
food
acid
and
is
naturally
occurring
in
the
environment
as
well
as
in
plants
and
animals.
Acetic
acid
is
utilized
as
an
energy
source
in
the
body
by
combining
first
with
Co­
enzyme
A
to
form
Acetyl­
CoA
which
then
enters
the
Kreb's
citric
acid
cycle
by
combining
with
oxaloacetate
to
yield
citrate.
This
process
is
active
in
all
animals
and
higher
plants
and
is
carried
out
in
the
mitochondria.

C.
Aggregate
Exposure
1.
Dietary
exposure.
Acetic
acid
is
a
food
acid
and
is
naturally
occurring
in
plants
and
animals.
Acetic
acid
is
utilized
as
an
energy
source
in
the
body
by
combining
first
with
Co­
enzyme
A
to
form
Acetyl­
CoA
which
then
enters
the
Kreb's
citric
acid
cycle
by
combining
with
oxaloacetate
to
yield
citrate.
This
process
is
active
in
all
animals
and
higher
plants
and
is
carried
out
in
the
mitochondria.
Acetic
acid
is
most
commonly
encountered
by
the
human
population
in
the
form
of
vinegar,
varying
in
concentration
of
acetic
acid,
from
4
 
7%.
Acetic
acid
is
considered
generally
recognized
as
safe
(
GRAS)
by
FDA
when
directly
added
to
foods
(
20
CFR
184.1005).
There
are
no
reports
in
the
literature
of
contact
sensitization
to
vinegar.
Used
in
accord
with
instructions
for
the
preservation
of
grain
and
hay,
the
concentration
of
acetic
acid
on
the
commodities
used
for
animal
food,
will
be
less
than
2%.
Dietary
exposure
to
acetic
acid
used
in
this
application
will
therefore
pose
no
threat
to
humans
or
the
environment.
2.
Non­
dietary
exposure.
The
only
non­
dietary
exposure
to
acetic
acid
is
the
occupational
exposure.
Acetic
acid
end­
use
products
are
sprayed
on
grains
and
hay
at
application
rates
in
ranges
of
less
than
3%
on
the
commodity,
depending
on
the
moisture
content
of
the
treated
crop.
Based
on
the
use
patterns,
the
potential
for
exposure
of
applicators
and
workers
in
the
field
being
treated
with
acetic
acid
could
be
significant.
However,
applicators
are
generally
confined
in
the
cab
of
the
tractor
pulling
the
collecting
systems
to
which
the
applicating
sprays
are
attached.
The
hay
or
grain
collected
would
contain
less
than
3%
of
the
acetic
acid
and
therefore
subsequent
exposure
to
the
crop
would
cause
no
significant
exposure
to
the
acetic
acid.
Certain
protective
clothing
is
recommended
for
acetic
acid
users
due
to
eye
and
skin
hazards
associated
with
the
handling
of
concentrated
acetic
acid
and
the
use
of
such
clothing
and
protective
equipment
is
presented
on
the
label.

D.
Cumulative
Effects
Acetic
acid
is
used
similarly
as
propionic
acid,
for
the
preservation
of
hay
and
grains.
Under
an
aerobic
conditions
propionic
acid
acts
as
a
carbon
source
for
various
microbes
and
is
metabolized
to
acetic
acid,
methane,
carbon
dioxide,
and
water.
For
propionic
acid,
the
metabolite
of
acetic
acid
poses
no
problems
because
acetic
acid
is
also
found
in
the
food
chain,
is
naturally
occurring,
and
is
applied
in
the
same
manner
as
propionic
acid
as
a
pesticide.
For
propionic
acid
all
environmental
fate
data
requirements
are
waived
for
the
uses
this
petition
requests
for
acetic
acid.
There
should
be
no
concern
for
cumulative
effects
for
acetic
acid
as
well.

E.
Safety
Determination
Human
health
assessment
 
i.
U.
S.
population.
Acetic
acid
is
a
normal
component
of
metabolism
in
the
human
body
and
humans
ordinarily
consume
acetic
acid
as
vinegar,
as
a
natural
component
of
common
foods,
and
as
an
added
ingredient.
Dietary
exposure
from
pesticidal
use
would
be
very
low.
ii.
Infants
and
children.
As
noted
above
acetic
acid
is
produced
by
the
human
body.
Humans
include
infants
and
children
as
well
as
adults.
For
the
same
reasons
as
above,
dietary
exposure
from
pesticidal
use
would
be
of
minimal
concern.

F.
Tolerance
Exemptions
for
the
Proposed
Uses
The
petitioner
proposes
that
the
use
of
acetic
acid
as
a
grain
and
hay
preservative
be
granted
an
exemption
from
the
requirement
of
a
tolerance,
as
proposed
below:
1.
Post­
harvest
application
of
acetic
acid,
when
used
as
a
fungicide
or
preservative
is
exempted
from
the
requirement
of
a
tolerance
for
residues
in
or
on
the
following
raw
agricultural
commodities:
Alfalfa,
barley
grain,
Bermuda
grass,
bluegrass,
brome
grass,
clover,
corn
grain,
cowpea
hay,
fescue,
lespedeza,
lupines,
oat
grain,
orchard
grass,
peanut
hay,
peavine
hay,
rye
grass,
sorghum
grain,
soybean
hay,
sudan
grass,
Timothy,
vetch,
and
wheat
grain,
or
commodities
described
as
grain
or
hay.
2.
Acetic
acid
is
exempt
from
the
requirement
of
a
tolerance
for
residues
in
or
on
meat,
and
meat
by­
products:
Cattle,
sheep,
hogs,
goats,
horses,
and
poultry,
milk,
and
eggs
when
applied
as
a
bactericide/
fungicide
to
livestock
drinking
water,
poultry
litter,
and
storage
areas
for
silage
and
grain.
3.
Post­
harvest
application
of
acetic
acid
when
used
as
a
fungicide/
preservative
is
exempted
from
the
requirement
of
a
tolerance
for
residues
in
or
on
the
following
raw
agricultural
commodities:
Cottonseed,
peanuts,
rice
grain,
and
soybeans.
Noticeably,
this
tolerance
exemption
request
re­
establishes
the
same
exemption
criteria
as
was
previously
granted
for
acetic
acid
for
this
use.

G.
International
Tolerances
There
are
no
known
international
tolerances
for
residues
of
acetic
acid
in
food
or
animal
feed.
[
FR
Doc.
03
 
14200
Filed
6
 
10
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
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2003
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2003
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