Document ID: EPA-HQ-OPP-2003-0121-0001
Agency: epa
Document Type: Proposed Rule
Title: Pesticides; Tolerance Exemptions for Active and Inert Ingredients for Use in Antimicrobial Formulations (Food-Contact Surface Sanitizing Solutions)
Posted Date: 2003-06-25T04:00Z

37778
Federal
Register
/
Vol.
68,
No.
122
/
Wednesday,
June
25,
2003
/
Proposed
Rules
number
of
small
entities
because:
this
rule
is
about
the
correctional
management
of
offenders
committed
to
the
custody
of
the
Attorney
General
or
the
Director
of
the
Bureau
of
Prisons,
and
its
economic
impact
is
limited
to
the
Bureau's
appropriated
funds.

Unfunded
Mandates
Reform
Act
of
1995
This
rule
will
not
cause
State,
local
and
tribal
governments,
or
the
private
sector,
to
spend
$
100,000,000
or
more
in
any
one
year,
and
it
will
not
significantly
or
uniquely
affect
small
governments.
We
do
not
need
to
take
action
under
the
Unfunded
Mandates
Reform
Act
of
1995.

Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996
This
rule
is
not
a
major
rule
as
defined
by
§
804
of
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996.
This
rule
will
not
result
in
an
annual
effect
on
the
economy
of
$
100,000,000
or
more;
a
major
increase
in
costs
or
prices;
or
significant
adverse
effects
on
competition,
employment,
investment,
productivity,
innovation,
or
on
the
ability
of
United
States­
based
companies
to
compete
with
foreignbased
companies
in
domestic
and
export
markets.

List
of
Subjects
in
28
CFR
Part
523
Prisoners.

Harley
G.
Lappin,
Director,
Bureau
of
Prisons.

Under
the
rulemaking
authority
vested
in
the
Attorney
General
in
5
U.
S.
C.
552(
a)
and
delegated
to
the
Director,
Bureau
of
Prisons,
we
propose
to
amend
28
CFR
part
523
as
follows.

SUBCHAPTER
B
 
INMATE
ADMISSION,
CLASSIFICATION,
AND
TRANSFER
PART
523
 
COMPUTATION
OF
SENTENCE
1.
The
authority
citation
for
28
CFR
part
523
is
revised
to
read
as
follows:

Authority:
5
U.
S.
C.
301;
18
U.
S.
C.
3568
(
repealed
November
1,
1987,
as
to
offenses
committed
on
or
after
that
date),
3621,
3622,
3624,
4001,
4042,
4081,
4082
(
Repealed
in
part
as
to
conduct
occurring
on
or
after
November
1,
1987),
4161
 
4166
(
repealed
October
12,
1984,
as
to
offenses
committed
on
or
after
November
1,
1987),
5006
 
5024
(
Repealed
October
12,
1984,
as
to
conduct
occurring
after
that
date),
5039;
28
U.
S.
C.
509,
510.

2.
Revise
§
523.20
to
read
as
follows:

§
523.20
Good
conduct
time.
(
a)
For
inmates
serving
a
sentence
for
offenses
committed
on
or
after
November
1,
1987,
but
before
September
13,
1994,
the
Bureau
will
award
54
days
credit
toward
service
of
sentence
(
good
conduct
time
credit)
for
each
year
served.
This
amount
is
prorated
when
the
time
served
by
the
inmate
for
the
sentence
during
the
year
is
less
than
a
full
year.
(
b)
For
inmates
serving
a
sentence
for
offenses
committed
on
or
after
September
13,
1994,
but
before
April
26,
1996,
all
yearly
awards
of
good
conduct
time
will
vest
for
inmates
who
have
earned,
or
are
making
satisfactory
progress
(
see
§
544.73(
b)
of
this
chapter)
toward
earning
a
General
Educational
Development
(
GED)
credential.
(
c)
For
inmates
serving
a
sentence
for
an
offense
committed
on
or
after
April
26,
1996,
the
Bureau
will
award:
(
1)
54
days
credit
for
each
year
served
(
prorated
when
the
time
served
by
the
inmate
for
the
sentence
during
the
year
is
less
than
a
full
year)
if
the
inmate
has
earned
or
is
making
satisfactory
progress
toward
earning
a
GED
credential
or
high
school
diploma;
or
(
2)
42
days
credit
for
each
year
served
(
prorated
when
the
time
served
by
the
inmate
for
the
sentence
during
the
year
is
less
than
a
full
year)
if
the
inmate
has
not
earned
or
is
not
making
satisfactory
progress
toward
earning
a
GED
credential
or
high
school
diploma.
(
d)
Notwithstanding
the
requirements
of
paragraphs
(
b)
and
(
c)
of
this
section,
an
alien
who
is
subject
to
a
final
order
of
removal,
deportation,
or
exclusion
is
eligible
for,
but
is
not
required
to,
participate
in
a
literacy
program,
or
to
be
making
satisfactory
progress
toward
earning
a
General
Educational
Development
(
GED)
credential,
to
be
eligible
for
a
yearly
award
of
good
conduct
time.
(
e)
The
amount
of
good
conduct
time
awarded
for
the
year
is
also
subject
to
disciplinary
disallowance
(
see
tables
3
through
6
in
§
541.13
of
this
chapter).

[
FR
Doc.
03
 
15823
Filed
6
 
24
 
03;
8:
45
am]

BILLING
CODE
4410
 
05
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0121;
FRL
 
7302
 
2]

Pesticides;
Tolerance
Exemptions
for
Active
and
Inert
Ingredients
for
Use
in
Antimicrobial
Formulations
(
Food­
Contact
Surface
Sanitizing
Solutions)

AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Proposed
rule.
SUMMARY:
EPA
is
proposing
to
add
a
new
section
to
part
180
which
lists
the
pesticide
chemicals
that
are
exempt
from
the
requirement
of
a
tolerance
when
used
in
food­
contact
surface
sanitizing
solutions.
The
initial
list
of
exempt
pesticide
chemicals
in
the
new
section
is
duplicated
from
the
Food
and
Drug
Administration's
(
FDA)
regulations
in
21
CFR
178.1010.
EPA
is
also
changing
FDA's
naming
conventions
for
some
of
the
chemical
substances
that
were
duplicated.
Until
recently,
FDA
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA)
section
409,
regulated
food­
contact
surface
sanitizing
solutions.
With
the
amendments
to
FFDCA
by
the
Food
Quality
Protection
Act
(
FQPA)
of
1996
and
by
the
Antimicrobial
Regulation
Technical
Corrections
Act
(
ARTCA)
of
1998,
these
responsibilities
have
been
restructured.
Under
FFDCA
section
408,
EPA
will
now
regulate
the
pesticide
uses
of
these
chemical
substances
and
FDA
under
FFDCA
section
409
will
continue
to
regulate
any
indirect
food
additive
uses
of
these
chemical
substances.
Registrants
of
existing
food­
contact
surface
sanitizing
solutions
that
contain
chemical
substances
other
than
those
listed
in
this
proposed
rule
should
identify
these
chemical
substances
and
support
their
claim
that
the
chemical
substance
is
generally
recognized
as
safe
(
GRAS),
or
permitted
by
FDA
prior
sanction,
or
approval,
or
subject
to
a
letter
of
no
objection
in
order
to
remain
exempt
from
the
requirement
of
a
FFDCA
section
408
tolerance.
DATES:
Comments,
identified
by
docket
ID
number
OPP
 
2003
 
0121,
must
be
received
on
or
before
July
25,
2003.
Registrants
should
identify
chemical
substances
not
listed
in
this
document
and
support
their
claims
of
GRAS,
or
prior
sanction,
or
approval,
or
no
objection
of
these
chemical
substances
by
submission
of
such
information
to
the
person
listed
under
FOR
FURTHER
INFORMATION,
on
or
before
October
1,
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.
Registrants
identifying
chemical
substances
not
listed
in
this
document
and
the
supporting
documentation
for
their
claims
of
GRAS,
or
prior
sanction,
or
approval,
or
no
objection
of
these
chemical
substances
for
inclusion
in
40
CFR
180.940
should
submit
the
information
directly
to
the
person
listed
under
FOR
FURTHER
INFORMATION.

VerDate
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15:
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2003
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37779
Federal
Register
/
Vol.
68,
No.
122
/
Wednesday,
June
25,
2003
/
Proposed
Rules
Identification
of
a
chemical
substance
is
not
a
comment
and
should
be
identified
as
``
Submission
of
Non­
designated
Prior
Approved
Substance.''

FOR
FURTHER
INFORMATION
CONTACT:
Kathryn
Boyle,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
6304;
fax
number:
(
703)
305
 
0599;
e­
mail
address:
boyle.
kathryn@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

You
may
be
potentially
affected
by
this
action
if
you
formulate
or
market
pesticide
products.
Potentially
affected
categories
and
entities
may
include,
but
are
not
limited
to:
 
Food
manufacturing
(
NAICS
311)
 
Antimicrobial
pesticides
(
NAICS
32561)
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
 
0121.
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.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.
Certain
types
of
information
will
not
be
placed
in
the
EPA
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.
1.
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.
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Vol.
68,
No.
122
/
Wednesday,
June
25,
2003
/
Proposed
Rules
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select
``
search,''
and
then
key
in
docket
ID
number
OPP
 
2003
 
0121.
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
 
0121.
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
 
0121.
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
 
0121.
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
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
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
your
estimate.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Offer
alternatives.
7.
Make
sure
to
submit
your
comments
by
the
comment
period
deadline
identified.
8.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
response.
It
would
also
be
helpful
if
you
provided
the
name,
date,
and
Federal
Register
citation
related
to
your
comments.

II.
What
is
the
Agency's
Authority
for
Taking
this
Action?

This
proposed
rule
is
issued
under
FFDCA
section
408,
21
U.
S.
C.
346a,
as
amended
by
FQPA
(
Public
Law
104
 
170),
and
ARTCA
(
Public
Law
105
 
324).
Section
408
of
FFDCA
authorizes
the
establishment
of
tolerances,
exemptions
from
the
requirement
of
a
tolerance,
modifications
in
tolerances,
and
revocation
of
tolerances
for
residues
of
pesticide
chemicals
in
or
on
raw
agricultural
commodities
and
processed
foods.
Section
408(
j)(
2)
of
FFDCA
provides
that
all
regulations
issued
by
FDA
under
FFDCA
section
409
that
stated
conditions
for
safe
use
of
substances
that
are
now,
post­
FQPA,
considered
pesticide
chemical
residues
in
or
on
processed
food
or
that
otherwise
stated
the
conditions
under
which
such
pesticide
chemicals
could
be
safely
used,
shall
be
deemed
to
be
regulations
issued
under
FFDCA
section
408.
Due
to
the
FQPA
and
ARTCA
amendments
to
FFDCA,
those
chemical
substances
originally
regulated
by
FDA
under
FFDCA
section
409
as
foodcontact
surface
sanitizing
solutions
are
now
the
responsibility
of
EPA.
These
pesticide
chemical
regulations
are
now
subject
to
modification
or
revocation
at
EPA's
initiative
under
FFDCA
section
408(
e).
The
Agency
is
proposing
to
duplicate
the
substance
of
FDA's
food
additive
regulations
for
those
chemical
substances
found
in
21
CFR
178.1010
which
are
now
pesticide
tolerance
exemptions
in
a
format
consistent
with
EPA's
authority
under
section
408
in
a
new
section,
40
CFR
180.940.
EPA's
rulemaking
activity
will
have
no
effect
on
any
of
the
FDA
regulated
FFDCA
section
409
food
additive
regulations
in
21
CFR
178.1010.

III.
Summary
of
this
Action
A.
Why
is
There
an
Overlap
of
EPA's
and
FDA's
Regulatory
Authorities?

Since
EPA
was
created
in
1970,
EPA
and
FDA
have
shared
authority
under
FFDCA
over
pesticide
chemical
residues
in
food.
Enactment
of
FQPA
in
1996
amended
FFDCA,
and
shifted
to
EPA
regulatory
authority
over
certain
pesticide
residues
which
were
previously
subject
to
FDA
authority.
Prior
to
1996,
products
used
to
sanitize
or
disinfect
permanent
or
semipermanent
food­
contact
surfaces
were
regulated
by
FDA
as
indirect
food
additives
under
FFDCA
section
409.
Under
the
FQPA
and
ARTCA
amendments
to
FFDCA,
antimicrobial
formulations
used
on
permanent
or
semi­
permanent
food­
contact
surfaces
other
than
food
packaging
are
now
considered
``
pesticide
chemicals''
and
are
regulated
by
EPA
under
FFDCA
section
408.
FQPA
added
a
provision
to
FFDCA
to
assure
an
orderly
transition
to
the
new
regulatory
system.
Section
408(
j)(
2)
of
FFDCA
provides
that
all
food
additive
regulations
issued
under
FFDCA
section
409
prior
to
the
enactment
of
FQPA
for
antimicrobial
uses
that
became
pesticide
chemical
uses
subsequent
to
FQPA
and
that
were
not
affected
by
ARTCA
shall
be
deemed
to
be
regulations
issued
under
FFDCA
section
408.
Thus,
FQPA
converted
existing
food
additive
regulations
issued
by
FDA
under
FFDCA
section
409,
for
chemical
substances
that
post­
FQPA
became
pesticide
chemicals,
into
FFDCA
section
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/
Vol.
68,
No.
122
/
Wednesday,
June
25,
2003
/
Proposed
Rules
408
pesticide
chemical
tolerances
or
tolerance
exemptions.
This
``
grandfather''
provision
of
FFDCA
section
408(
j)
assures
that
pesticide
chemical
residues
conforming
to
regulations
issued
under
the
authority
of
FFDCA
section
409
will
not
render
food
adulterated
as
a
result
of
the
jurisdictional
shift
from
FDA
to
EPA.
In
1998,
ARTCA
amended
the
definition
of
``
pesticide
chemical''
in
FFDCA
section
201(
q)
so
as
to
exclude
certain
antimicrobial
pesticide
residues
from
the
authority
of
FFDCA
section
408.
Consistent
with
FFDCA
section
408(
j)(
4),
these
residues
now
fall
within
the
authority
of
FFDCA
section
409.
As
a
result,
certain
uses
of
food­
contact
surface
sanitizing
solutions
identified
in
FDA's
regulations
at
21
CFR
178.1010
remain
subject
to
FFDCA
section
409
regulations
just
as
they
did
pre­
FQPA,
while
other
uses
are
now
subject
to
EPA's
jurisdiction
under
FFDCA
section
408.

B.
Why
are
these
Tolerance
Exemptions
not
Subject
to
Tolerance
Reassessment
at
this
Time?
Under
FFDCA
section
408(
q),
EPA
is
required
to
reassess
all
tolerance
exemptions
that
were
in
effect
on
the
day
before
the
enactment
of
the
FQPA.
The
tolerance
exemptions
for
inert
ingredients
as
well
as
those
active
ingredients
not
yet
completed
will
be
reassessed
in
accordance
with
EPA's
schedule
for
tolerance
reassessment
published
in
the
Federal
Register
of
August
4,
1997
(
62
FR
42019)
(
FRL
 
5734
 
6).
The
tolerance
exemptions
in
this
proposed
rule
to
be
codified
in
40
CFR
180.940
already
exist
as
valid
FFDCA
section
408
regulations.
FDA
promulgated
the
food
additive
regulations
in
21
CFR
178.1010
under
the
authority
of
FFDCA
section
409
prior
to
the
enactment
of
FQPA.
By
operation
of
FFDCA
section
408(
j)(
2),
those
portions
of
21
CFR
178.1010
that
pertain
to
chemical
substances
that
are
pesticide
chemicals
post­
FQPA
and
remain
as
such
post­
ARTCA
were
converted
to
FFDCA
section
408
tolerance
exemptions.
EPA's
duplication
of
these
tolerance
exemptions
is
not
``
establishing,
modifying,
or
revoking
a
tolerance''
under
FFDCA
section
408(
b).
EPA
is,
therefore,
not
required
to
conduct
a
full
reassessment
of
these
tolerance
exemptions
at
this
time.

C.
Why
is
40
CFR
180.940
being
Created?
The
Agency
is
duplicating
in
40
CFR
180.940
only
those
portions
of
the
regulations
in
21
CFR
178.1010
that
pertain
to
pesticide
chemicals.
This
duplication
will
have
no
effect
on
any
of
FDA's
regulated
FFDCA
section
409
food
additive
regulations
in
21
CFR
178.1010.
In
establishing
food
additive
regulations
for
food­
contact
surface
sanitizing
solutions
in
21
CFR
178.1010,
FDA
used
a
formulation­
specific
approach.
Consistent
with
its
authority
under
FFDCA
section
409,
FDA
issued
regulations
prescribing
the
conditions
under
which
food­
contact
surface
sanitizing
solutions
might
be
safely
used.
FDA
approved
the
use
of
each
food­
contact
surface
sanitizing
solution
formulation
as
a
whole,
rather
than
regulating
each
component
chemical
substance
individually.
In
addition,
FDA
included
a
generic
exemption
for
any
chemical
substance
considered
to
be
GRAS,
and
in
some
cases,
issued
letters
not
objecting
to
certain
additional
chemical
substances
in
the
formulations.
By
contrast,
FFDCA
section
408
authorizes
EPA
to
issue
regulations
establishing
tolerances
or
exemptions
from
the
requirement
of
a
tolerance.
EPA's
practice
has
been
to
issue
these
regulations
on
a
chemical­
specific
basis,
whereby
each
ingredient
in
the
product
is
the
subject
of
a
separate
tolerance
or
exemption
regulation.
Food­
contact
surface
sanitizing
solutions
meet
the
requirements
of
FFDCA
if
each
ingredient
has
an
appropriate
clearance
under
FFDCA,
either
a
tolerance
or
an
exemption
from
the
requirement
of
a
tolerance,
and
any
conditions
on
the
clearance
are
observed.
Translating
the
regulatory
decisions
made
by
FDA
into
a
comparable
EPA
scheme
requires
considerably
greater
work
on
EPA's
part
than
merely
copying
those
portions
of
the
existing
regulations
in
21
CFR
178.1010
that
pertain
to
pesticide
chemicals
directly
into
40
CFR
180.940.
EPA
must
disaggregate
the
formulations
in
21
CFR
178.1010
that
pertain
to
pesticide
chemicals
into
their
component
ingredients.
EPA
must
also
provide
a
mechanism
to
address
those
ingredients
not
identified
by
name
in
21
CFR
178.1010
but
that
were,
for
example,
permitted
by
prior
sanction
or
approval,
not
objected
to,
or
generally
recognized
as
safe.
This,
in
fact,
places
a
higher
initial
demand
on
EPA
resources
than
would
be
required
to
simply
copy
FDA's
approach.
However,
EPA
is
convinced
that
the
long­
term
administrative
convenience
of
using
a
consistent
regulatory
scheme
for
all
pesticide
chemicals
subject
to
FFDCA
section
408
outweighs
the
initial
burdens.
FDA's
formulation­
specific
approach
is
different
from
EPA's
chemicalspecific
approach.
Under
EPA's
approach,
a
tolerance
exemption
would
be
approved
once
for
each
particular
pesticide
chemical,
and
would
not
need
to
be
repeated
as
new
products
containing
that
chemical
substance
enter
the
market.
EPA's
approval
process
is
not
complex,
will
allow
for
a
wide
variety
of
potential
products,
and
fosters
innovative
formulation
approaches.
In
addition,
by
listing
in
one
place
(
40
CFR
180.940)
all
chemical
substances
exempted
from
the
requirement
of
a
tolerance
when
used
in
food­
contact
surface
sanitizing
solutions,
EPA's
approach
will
increase
the
transparency
of
its
regulatory
process.
This
duplication
will
not
allow
any
residues
beyond
those
already
permitted
by
21
CFR
178.1010.
EPA
believes
that
the
chemical­
specific
approach
and
FDA's
formulation­
specific
approach
are
equivalent
from
a
risk
management
perspective,
inasmuch
as
each
would
result
in
the
same
levels
of
residues
from
these
chemical
substances.
As
part
of
the
duplication,
EPA
changed
the
naming
conventions
(
chemical
nomenclature),
as
well
as
combining,
as
appropriate,
chemical
substances
that
appear
in
21
CFR
178.1010
under
two
or
more
names
under
a
single
name.
The
Agency
has
attempted
to
identify
each
of
the
listed
chemical
substances
using
the
Chemical
Abstracts
Service
Registry
Number
(
CAS
No.).
The
CAS
No.
provides
one
of
the
most
distinct
and
universally
accepted
means
of
identifying
chemical
substances.
Generally,
there
will
be
only
one
CAS
No.
per
listed
chemical
substance;
however,
it
is
possible
that
more
than
one
CAS
No.
may
be
appropriate
for
some
chemical
substances.
The
lack
of
a
CAS
No.
will
not
preclude
EPA
from
including
chemical
substances
in
40
CFR
180.940.
The
lower­
concentration
limits
specified
in
21
CFR
178.1010
are
not
included
in
40
CFR
180.940
because
of
the
differences
between
FDA's
approach
and
EPA's
approach.
Although
EPA
establishes
tolerance
exemptions
for
use
in
food­
contact
surface
sanitizing
solutions
under
FFDCA,
all
pesticide
products
must
also
meet
the
criteria
for
registration
under
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
before
being
offered
for
sale.
EPA
relies
on
conditions
imposed
through
the
FIFRA
registration
process
to
address
safety
and
for
antimicrobialformulated
products
efficacy.
Accordingly,
the
lower
limits
on
concentrations
of
pesticide
chemicals,
that
appear
in
21
CFR
178.1010
will
not
appear
in
40
CFR
180.940.
Three
types
of
food­
contact
surface
sanitizing
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/
Vol.
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No.
122
/
Wednesday,
June
25,
2003
/
Proposed
Rules
solutions
are
described
in
21
CFR
178.1010:
 
Those
used
on
food­
contact
surfaces
in
public
eating
places.
 
Those
used
on
dairy­
processing
equipment.
 
Those
used
on
food­
processing
equipment
and
utensils.
According
to
FDA,
food­
contact
surface
sanitizing
solutions
that
are
acceptable
for
use
on
food­
contact
surfaces
in
public
eating
places
can
also
be
used
on
dairy­
processing
equipment,
and
on
food­
processing
equipment
and
utensils.
Food­
contact
surface
sanitizing
solutions
that
are
acceptable
for
use
on
dairy
equipment
can
also
be
used
on
food­
processing
equipment
and
utensils.
EPA
has
separated
the
component
ingredients
by
both
chemical
and
concentration
for
these
three
types
of
food­
contact
surface
sanitizing
solutions,
which
will
be
included
in
40
CFR
180.940.

IV.
Issuance
and
Withdrawal
of
Direct
Final
Rule
In
the
Federal
Register
of
December
3,
2002
(
67
FR
71847)
(
FRL
 
6824
 
2),
the
Agency
published
a
direct
final
rule
to
establish
40
CFR
180.940.
Comments
were
received.
In
the
December
3,
2002
Federal
Register
notice,
EPA
announced
that
it
would
withdraw
the
direct
final
rule
if
it
received
adverse
comment,
and
proceed
with
proposed
rule
as
provided
by
section
553
of
the
Administrative
Procedure
Act,
5
U.
S.
C.
553.
Because
some
of
the
comments
were
of
a
nature
that
would
warrant
a
response
if
made
on
a
proposed
rule,
they
are
adverse
comments
that
require
withdrawal
of
the
direct
final
rule.
Accordingly,
EPA
withdrew
the
direct
final
rule
on
March
24,
2003
(
68
FR
14165)
(
FRL
 
7299
 
4).
Several
of
the
comments
reflected
some
understandable
confusion
on
the
part
of
the
commenters.
While
EPA's
chemical­
specific
approach
and
FDA's
formulation
specific
approach
are
essentially
equivalent,
the
two
approaches
look
and
read
differently.
EPA
disaggregated
the
46
formulations
in
21
CFR
178.1010
into
a
list
of
chemicals.
This
list
of
chemicals
was
then
subdivided
into
three
separate
lists
based
on
use
categories
in
21
CFR
178.1010
(
i.
e.,
food­
contact
surfaces
in
public
eating
places,
dairy
processing
equipment,
and
food­
processing
equipment
and
utensils).
The
40
CFR
180.940(
a)
list
contains
only
the
chemicals
specified
in
those
formulations
that
were
designated
by
FDA
for
use
in
public
eating
places.
The
40
CFR
180.940(
b)
list
contains
only
the
chemicals
specified
in
those
formulations
that
were
designated
by
FDA
for
use
on
dairy
equipment.
The
40
CFR
180.940(
c)
list
contains
all
chemicals
because
all
formulations
in
21
CFR
178.1010
can
be
used
on
foodprocessing
equipment
and
utensils.
The
maximum
concentration
level
for
each
chemical
was
determined
by
evaluating
the
range
derived
from
the
lists
in
40
CFR
180.940(
a),
(
b),
or
(
c).
Where
21
CFR
178.1010
authorized
several
different
sanitizing
solutions
each
containing
a
particular
chemical,
but
at
different
concentrations,
EPA
will
use
only
the
highest
concentration
as
the
upper
limit,
reflecting
FDA's
implicit
determination
that
concentrations
up
to
and
including
that
limit
do
not
compromise
food
safety.
As
an
example,
if
three
solutions
authorized
under
21
CFR
178.1010
for
use
on
dairy
equipment
contain
chemical
``
X''
at
concentrations
of
150,
200,
and
240
parts
per
million
(
ppm),
then
240
ppm
would
be
used
as
the
upper
limit
in
40
CFR
180.940(
b).
If
for
chemical
``
Y,''
concentrations
of
150
and
200
ppm
were
specified,
but
in
a
third
solution
the
concentration
was
not
specified,
then
the
upper
limit
for
chemical
``
Y
''
in
40
CFR
180.940(
c)
would
be
specified
as
``
none.''
This
reflects
FDA's
implicit
determination
in
regard
to
that
third
sanitizing
solution
that
chemical
``
Y
''
could
be
used
in
any
concentration
without
significant
risk
to
food
safety.
In
addition
to
the
disaggregation,
the
Agency
also
in
some
cases
used
a
different
chemical
nomenclature.
CI
(
chemical
index)
names
and
CAS
Nos.
were
used
to
the
greatest
extent
possible.
This
is
part
of
an
Agency­
wide
effort
to
provide
a
common
and
consistent
way
to
identify
and
represent
chemical
substances
across
the
Agency.
Thus,
sodium
hypochlorite
became
hypochlorous
acid,
sodium
salt.
In
other
instances
(
most
commonly
involving
polymers
or
quaternary
ammonium
compounds),
FDA
approved
in
one
solution
a
particular
chemical
that
falls
within
a
more
inclusive
chemical
designation
approved
in
another
solution.
If
practicable
in
such
instances,
EPA
has
stated
the
tolerance
exemption
only
in
terms
of
the
more
inclusive
chemical
designation,
implicitly
exempting
all
chemical
substances
that
fall
within
that
designation.
For
example,
n­
alkyl
(
C12
 
C16)
benzyl
dimethyl
ammonium
chloride
would
be
considered
to
be
a
subset
of
n­
alkyl
(
C12
 
C18)
benzyl
dimethyl
ammonium
chloride.
Another
example,
n­
alkyl
(
C12
 
C18)
benzyl
dimethyl
ammonium
chloride
(
mw
351
to
380)
would
also
be
considered
a
subset
of
n­
alkyl
(
C12
 
C18)
benzyl
dimethyl
ammonium
chloride.
Both
of
the
example
chemicals
would
be
accounted
for
under
the
nomenclature
quaternary
ammonium
compounds
alkyl
(
C12
 
C18)
benzyl
dimethyl,
chlorides.
For
each
comment
questioning
whether
a
particular
chemical
substance
appeared
in
the
direct
final
rule,
the
Agency
was
able
to
verify
that
the
chemical
for
which
the
commenter
expressed
concern
was
included
in
40
CFR
180.940,
albeit
under
a
different
designation.
A
commenter
asked
that
instead
of
using
the
term
``
oxychloro
species,''
that
sodium
chlorite
or
chlorine
dioxide
should
be
used
instead.
The
``
generated
by''
language
was
considered
to
be
confusing
in
a
listing
of
chemical
names.
The
Agency
(
as
acknowledged
by
the
commenter)
used
FDA's
language,
which
is
an
approach
which
describes
the
process
for
generating
the
solution,
not
the
components
of
the
solution.
If
the
end­
products
of
the
generation
process
were
specific
chemicals
already
included
in
the
other
solutions
(
and
therefore
already
lineitems
then
the
Agency
used
the
disaggregated
approach.
However,
for
the
oxychloro
species
generation
methods
described
in
21
CFR
178.1010(
b)(
34),
the
chlorite,
chlorate,
and/
or
chlorine
dioxide
is
actually
an
equilibrium
mixture.
There
are
no
separate
line­
item
entries
for
these
chemicals.
In
fact,
the
upper
concentration
limit
is
specified
in
terms
of
chlorine
dioxide
only,
thus
making
it
difficult
to
separate
the
chemicals
into
line
items.
The
Agency
determined
therefore
to
maintain
the
original
FDA
language
at
this
time.
The
Agency
also
considered
that
other
generation
methods
for
oxychloro
species
could
be
submitted
as
part
of
the
non­
designated
prior
approved
chemical
substances,
which
could
impact
the
handling
of
this
in
the
future.
Several
commenters
asked
if
a
specific
combination
of
quaternary
ammonium
compounds
expressly
identified
in
21
CFR
178.1010(
b)(
22)
were
included
in
40
CFR
180.940.
Each
of
the
component
chemicals
identified
in
21
CFR
178.1010(
b)(
22)
are
identified
in
40
CFR
180.940
as
subject
to
a
tolerance
exemption.
The
two
components
listed
in
21
CFR
178.1010(
b)(
22)
are
di­
n­
alkyl
(
C8
 
C10)
dimethylammonium
chloride
(
mw
332
to
361)
and
n­
alkyl
(
C12
 
C18)
benzyl
dimethyl
ammonium
chloride
(
mw
351
to
380).
The
first
chemical
is
listed
in
40
CFR
180.940
as
``
Quaternary
ammonium
compounds,
di­
n­
alkyl
(
C8
 
C10)
dimethyl
ammonium
chloride
average
molecular
weight
(
in
amu)
332
to
361.''
21
CFR
178.1010(
b)(
22)
and
21
CFR
178.1010(
c)(
17)
together
allow
a
maximum
end­
use
concentration
of
400
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/
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25,
2003
/
Proposed
Rules
ppm
of
the
two
quaternary
ammonium
compounds
in
this
solution,
of
which
this
particular
chemical
must
comprise
60%.
EPA's
regulation
exempts
this
chemical
substance
from
the
requirement
of
a
tolerance
in
sanitizing
solutions
up
to
240
ppm,
which
is
60%
of
the
400
ppm
authorized
in
the
FDA
regulations.
The
second
chemical
is
listed
in
40
CFR
180.940
as
``
Quaternary
ammonium
compounds,
alkyl
(
C12
 
C18)
benzyl
dimethyl,
chlorides.''
The
end
use
concentration
as
specified
in
21
CFR
178.1010(
b)(
22)
and
21
CFR
178.1010(
c)(
17)
for
this
chemical
would
be
40%
of
400
ppm
or
160
ppm.
Because
other
solutions
in
21
CFR
178.1010
included
chemical
substances
within
the
description
``
quaternary
ammonium
compounds,
alkyl
(
C12
 
C18)
benzyl
dimethyl,
chlorides''
without
molecular
weight
limitations
and/
or
with
higher
concentration
limits,
the
description
of
this
chemical
in
40
CFR
180.940
is
more
broad
than
that
of
21
CFR
178.1010(
b)(
22).
Based
on
one
comment,
the
Agency
was
made
aware
of
a
typographical
error
in
the
December
3,
2002
Federal
Register
notice
which
has
been
corrected
in
this
notice
of
proposed
rulemaking.
In
40
CFR
180.940(
a)
the
upper
limit
should
be
not
150
ppm,
but
200
ppm
for
C12
 
C16
benzyl
dimethyl
ammonium
chloride
(
mw
351
 
380).
With
the
change
in
upper
limit
to
200
ppm,
C12
 
C16
benzyl
dimethyl
ammonium
chloride
(
mw
351
to
380)
can
be
appropriately
held
under
the
more
inclusive
quaternary
ammonium
compounds
alkyl
(
C12
 
C18)
benzyl
dimethyl,
chlorides.
Another
commenter
requested
that
the
Agency
change
the
language
describing
the
upper
limit
concentration
for
all
quaternary
ammonium
compounds.
The
commenter
has
suggested
the
use
of
the
phrase
``
when
ready
to
use,
the
end­
use
concentration
is
not
expected
to
exceed
`
X'
ppm
of
this
active
quaternary
ammonium
compound,''
instead
of
the
phrasing
used
by
the
Agency
``
when
ready
for
use,
concentration
is
not
to
exceed
`
X'
ppm
of
active
quaternary
compound.''
The
commenter
cited
the
concern
that
state
enforcement
personnel
would
apply
the
limitation
for
a
particular
quaternary
ammonium
compound
to
a
mixture.
The
Agency
believes
that
the
language
it
has
used
is
clear
and
concise.
The
concentration
limits
specified
in
40
CFR
180.940
apply
only
to
the
chemical
substance
described
in
the
particular
table
entry.
However,
the
30­
day
comment
period
will
allow
the
Agency
to
take
further
comment
on
this
issue.
A
commenter
asked
that
the
Agency
not
distinguish
between
food­
contact
surfaces
in
public
eating
places,
dairyprocessing
equipment,
and
food
processing
equipment
and
utensils.
These
categories
were
originally
created
by
the
FDA
and
reflect
different
assumptions
especially
with
regard
to
dietary
exposure
to
sanitizer
residues,
and
thus
are
an
intrinsic
part
of
FDA's
risk
assessments.
Although
EPA
has
the
authority
to
reconsider
FDA's
risk
assessments,
EPA
can
do
so
only
upon
fully
reassessing
these
tolerance
exemptions
in
accordance
with
FFDCA
section
408,
as
amended
by
FQPA.
EPA
is
not
reassessing
these
tolerance
exemptions
at
this
time,
but
instead
merely
duplicating
FDA's
previous
clearances
in
a
format
consistent
with
EPA's
authority
under
FFDCA
section
408.
EPA
is
required
under
FFDCA
section
408(
q)(
1)(
C)
to
complete
tolerance
reassessment
for
all
pesticide
chemicals
by
2006,
and
will
consider
the
commenter's
suggestion
during
tolerance
reassessment.
Although
not
raised
by
commenters,
EPA
has
made
three
additional
changes
from
the
December
3,
2003
Federal
Register
notice.
D&
C
Blue
No.
1
(
methylene
blue)
is
now
referenced
as
methylene
blue.
Similarly,
FD&
C
Yellow
No.
5
(
tartrazine)
is
now
referenced
as
FD&
C
Yellow
No.
5.
A
CAS
No.
was
added
to
one
entry
(
quaternary
ammonium
compounds,
alkyl
(
C12
 
C18)
benzyl
dimethyl,
chlorides)
in
40
CFR
180.940(
a).

V.
Addition
of
Non­
Designated,
Prior
Approved
Chemical
Substances
21
CFR
178.1010
allows
the
use
of
GRAS
chemical
substances
and
chemical
substances
``
permitted
by
prior
sanction
or
approval,''
that
are
not
expressly
identified.
These
chemical
substances
were
subject
to
the
sanitizer
formulation
approval
under
FDA's
regulation
before
these
uses
became
FFDCA
section
408
tolerance
exemptions
under
FFDCA
section
408(
j)(
2).
Accordingly,
many
foodcontact
sanitizing
solutions
that
presently
are
authorized
for
use
under
21
CFR
178.1010
contain
ingredients
which
are
not
identified
in
this
direct
final
rule.
As
discussed
in
this
unit,
EPA
is
asking
registrants
to
identify
these
other
ingredients
that
they
believe
should
be
included
in
40
CFR
180.940.
EPA
intends
to
publish
a
revision
to
40
CFR
180.940
adding
these
chemical
substances.
In
the
interim,
to
preserve
the
use
of
food­
contact
surface
sanitizing
solutions
that
were
cleared
for
use
before
FQPA's
enactment
and
that
contain
chemical
substances
that
are
not
specifically
identified
in
21
CFR
178.1010,
EPA
has
decided
to
honor
those
approvals
under
21
CFR
178.1010
until
EPA
has
received
and
reviewed
registrant's
claims
with
respect
to
unspecified
pesticide
chemicals,
as
discussed
in
this
unit.
FDA's
regulations
(
21
CFR
178.1010(
b))
allowed
the
addition
to
food­
contact
surface
sanitizing
solutions
of
GRAS
components,
and
components
permitted
by
prior
sanction
or
approval
or
subject
to
a
letter
of
no
objection.
Much
of
this
information
should
be
in
EPA's
files.
The
Agency
will
access
this
information.
However,
EPA
may
not
have
ready
access
to
all
information
on
all
chemicals
in
existing
food­
contact
surface
sanitizing
solution
formulations
which
could
meet
these
criteria.
Submission
of
this
information
to
EPA
would
also
reduce
the
possibility
of
an
existing
food­
contact
surface
sanitizing
solution
having
a
component
that
lacks
a
tolerance
exemption
under
40
CFR
180.940.
Therefore,
registrants
who
believe
that
components
of
their
foodcontact
surface
sanitizing
solutions
are
exempted
under
21
CFR
178.1010(
b)
should
advise
EPA
in
writing
that
these
chemical
substances
(
along
with
the
CAS
No.)
should
be
included
in
40
CFR
180.940.
The
submission
of
this
information
facilitates
EPA's
process
for
adding
these
chemical
substances
cleared
under
21
CFR
178.1010(
b),
but
not
specifically
listed
by
name,
to
40
CFR
180.940.
The
EPA
will
also
need
any
available
information
documenting
the
claim
that
the
component
is
GRAS,
prior
sanctioned
or
approved,
or
subject
to
a
letter
of
no
objection.
Claims
and
supporting
documentation
should
be
sent
to
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
Claims
are
not
comments
on
this
direct
final
rule
and
should
be
identified
on
the
subject
line
as
``
Submission
of
Non­
designated
Prior
Approved
Chemical
Substance.''
If
you
have
any
questions
about
the
many
types
of
information
that
could
be
submitted
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
The
Agency
does
not
anticipate
that
registrants
will
be
required
to
submit
an
excessive
amount
of
information,
and,
in
fact,
believes
that
most
registrants
will
be
able
to
submit
the
necessary
information
with
minimal
effort.
EPA
will
review
and
evaluate
the
information
provided.
Chemical
substances
identified
in
claims
received
not
later
than
October
1,
2003,
may
be
eligible
for
inclusion
in
40
CFR
180.940
under
FFDCA
section
408(
j)(
2).
EPA
anticipates
publishing
a
notice
of
proposed
rulemaking
identifying
those
chemical
substances
shortly
after
that
date.

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Vol.
68,
No.
122
/
Wednesday,
June
25,
2003
/
Proposed
Rules
VI.
Statutory
and
Executive
Order
Reviews
This
proposed
rule
would
add
a
new
§
180.940
to
40
CFR
part
180,
subpart
D,
which
lists
the
pesticide
chemicals
that
are
exempt
from
the
requirement
of
a
tolerance
when
used
in
food­
contact
surface
sanitizing
solutions.
The
initial
list
duplicates
pesticide
chemicals
in
40
CFR
180.940
that
are
active
and
inert
ingredients
listed
in
21
CFR
178.1010.
Since
this
proposed
rule
does
not
impose
any
new
requirements,
it
is
not
subject
to
review
by
the
Office
of
Management
and
Budget
(
OMB)
under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993).
Because
this
proposed
rule
has
been
exempted
from
review
under
Executive
Order
12866
due
to
its
lack
of
significance,
this
proposed
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
proposed
rule
does
not
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).
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
proposed
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
proposed
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
proposed
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
proposed
rule.
Under
section
605(
b)
of
the
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et
seq.),
the
Agency
hereby
certifies
that
the
creation
of
a
new
section
180.940
will
not
have
significant
negative
economic
impact
on
a
substantial
number
of
small
entities.
The
rationale
supporting
this
conclusion
is
as
follows.
This
proposed
rule
does
not
impose
any
requirements,
it
establishes
exemptions
from
the
requirement
for
a
tolerance.
The
Agency
is,
however,
also
commencing
a
process
whereby
EPA
will
require
certain
persons
to
identify
chemical
substances
considered
to
be
GRAS
(
which
could
include
self­
affirmed
GRAS
chemicals),
or
permitted
by
prior
sanction
or
approval
in
existing
food
contact
surface
sanitizing
solutions.
The
information
available
to
the
Agency
indicates
that
fewer
than
500
companies
have
approximately
1,300
products
that
could
fall
under
this
category.
EPA
anticipates
the
economic
burden
on
small
entities
to
be
minor,
since
the
Agency
is
only
asking
for
confirmation
that
the
chemical
substances
considered
to
be
GRAS
or
permitted
by
prior
sanction
or
approval
in
existing
food
contact
surface
sanitizing
solutions
are
in
fact
part
of
an
existing
formulation,
and
information
as
to
why
the
chemical
is
considered
to
be
GRAS,
or
a
copy
of
an
FDA
letter
not
objecting
to
the
use
of
a
chemical
substance.
By
contrast,
this
proposed
rule
will
be
beneficial
to
the
regulated
community
by
increasing
the
number
of
inert
ingredients
for
use
in
antimicrobial
formulations
and
by
reducing
the
regulatory
burden
on
persons
seeking
to
market
new
combinations
of
ingredients
for
certain
hard
surface
sanitizing
solutions.
Additionally,
this
proposed
rule
will
provide
a
more
transparent
listing
of
pesticide
chemicals
used
in
foodcontact
surface
sanitizing
solutions
to
the
public.
According
to
the
Paperwork
Reduction
Act
(
PRA),
44
U.
S.
C.
3501
et
seq.,
an
Agency
may
not
conduct
or
sponsor,
and
a
person
is
not
required
to
respond
to
a
collection
of
information
that
requires
OMB
approval
under
the
PRA,
unless
it
has
been
approved
by
OMB
and
displays
a
currently
valid
OMB
control
number.
The
OMB
control
numbers
for
EPA's
regulations,
after
initial
display
in
the
preamble
of
the
final
rule
and
in
addition
to
its
display
on
any
related
collection
instrument,
are
listed
in
40
CFR
part
9.
This
proposed
rule
does
not
impose
any
new
information
collection
requirements
that
would
require
separate
approval
by
OMB
under
the
PRA.
Under
5
CFR
1320.3(
h),
the
request
for
information
discussed
in
Unit
V.
is
not
subject
to
approval
under
the
PRA,
and
the
information
collection
activities
related
to
the
Agency's
tolerance
exemption
process
have
already
been
approved
by
OMB
under
OMB
control
numbers
2070
 
0024
(
EPA
ICR
No.
597).
The
annual
``
respondent''
(
petitioner)
burden
for
the
pesticide
tolerance
petitions
program
is
estimated
to
average
1,726
hours
per
petition.
According
to
the
PRA,
``
burden''
means
the
total
time,
effort,
or
financial
resources
expended
by
persons
to
generate,
maintain,
retain,
or
disclose
or
provide
information
to
or
for
a
Federal
agency.
For
this
collection,
it
is
the
time
reading
the
regulations,
planning
the
necessary
data
collection
activities,
conducting
tests,
analyzing
data,
generating
reports
and
completing
other
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122
/
Wednesday,
June
25,
2003
/
Proposed
Rules
required
paperwork,
and
storing,
filing,
and
maintaining
the
data.
Send
comments
regarding
this
burden
estimate
or
any
other
aspect
of
the
collection
activity,
including
suggestions
for
reducing
the
burden
to:
Director,
Collection
Strategies
Division
(
2822),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
Include
the
OMB
control
number
2070
 
0024
in
any
correspondence
about
this
collection
activity,
but
do
not
submit
the
requested
information
or
forms
to
this
address.

List
of
Subjects
in
40
CFR
Part
180
Environmental
protection,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.
Dated:
June
11,
2003.
James
Jones,
Director,
Office
of
Pesticide
Programs.
Therefore,
it
is
proposed
that
40
CFR
chapter
I
be
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),
346a
and
371.
2.
A
new
§
180.940
is
added
to
subpart
D
of
part
180
to
read
as
follows.

§
180.940
Food­
contact
surface
sanitizing
solutions;
exemptions
from
the
requirement
of
a
tolerance.

Residues
of
the
following
chemical
substances
are
exempted
from
the
requirement
of
a
tolerance
when
used
in
accordance
with
good
manufacturing
practice
as
ingredients
in
an
antimicrobial
pesticide
formulation,
provided
that
the
chemical
substance
is
applied
on
a
semi­
permanent
or
permanent
food­
contact
surface
(
other
than
being
applied
on
food
packaging)
with
adequate
draining
before
contact
with
food.
(
a)
The
following
chemical
substances
when
used
as
ingredients
in
an
antimicrobial
pesticide
formulation
may
be
applied
to:
Food­
contact
surfaces
in
public
eating
places,
dairy­
processing
equipment,
and
food­
processing
equipment
and
utensils.

Pesticide
chemical
CAS
No.
Limits
Acetic
acid
64
 
19
 
7
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
290
parts
per
million
(
ppm)

a­
Alkyl(
C10
 
C14)­
 ­
hydroxypoly(
oxyethylene)
poly
(
oxypropylene)
average
molecular
weight
(
in
amu),
768
to
837
None
None
a­
Alkyl(
C12
 
C18)­
 ­
hydroxypoly(
oxyethylene)
poly(
oxypropylene)
average
molecular
weight
(
in
amu),
950
to
1,120
None
None
Ammonium
chloride
12125
 
02
 
9
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
48
ppm
Dextrin
9004
 
53
 
9
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
16
ppm
Ethanol
64
 
17
 
5
None
Ethylenediaminetetraacetic
acid
(
EDTA),
tetrasodium
salt
64
 
02
 
8
None
Hydrogen
peroxide
7722
 
84
 
1
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
91
ppm
Hypochlorous
acid,
sodium
salt
7681
 
52
 
9
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
200
ppm
determined
as
total
available
chlorine
Iodine
7553
 
56
 
2
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
25
ppm
of
titratable
iodine
Magnesium
oxide
1309
 
48
 
4
None
Methylene
blue
61
 
73
 
4
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
0.4
ppm
a­(
p­
Nonylphenyl)­
 ­
hydroxypoly(
oxyethylene)
average
poly(
oxyethylene)
content
11
moles)
None
None
Octadecanoic
acid,
calcium
salt
1592
 
23
 
0
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
16
ppm
1­
Octanesulfonic
acid,
sodium
salt
5324
 
84
 
5
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
46
ppm
of
total
active
fatty
acids
Octanoic
acid
124
 
07
 
2
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
52
ppm
of
total
active
fatty
acids
Oxirane,
methyl­,
polymer
with
oxirane,
minimum
molecular
weight
(
in
amu),
1,900
9003
 
11
 
6
None
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Vol.
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122
/
Wednesday,
June
25,
2003
/
Proposed
Rules
Pesticide
chemical
CAS
No.
Limits
Peroxyacetic
acid
79
 
21
 
0
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
58
ppm
Peroxyoctanoic
acid
33734
 
57
 
5
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
52
ppm
Phosphonic
acid,
(
1­
hydroxyethylidene)
bis­
2809
 
21
 
4
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
14
ppm
Phosphoric
acid,
trisodium
salt
7601
 
54
 
9
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
5,916
ppm
Potassium
bromide
7758
 
02
 
3
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
46
ppm
total
available
halogen
Potassium
iodide
7681
 
11
 
0
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
25
ppm
of
titratable
iodine
Potassium
permanganate
7722
 
64
 
7
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
0.7
ppm
2­
Propanol
(
isopropanol)
67
 
63
 
0
None
Quaternary
ammonium
compounds,
alkyl
(
C12
 
C18)
benzyl
dimethyl,
chlorides
8001
 
54
 
5
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
200
ppm
of
active
quaternary
compound
Quaternary
ammonium
compounds,
n­
alkyl
(
C12
 
C14)
dimethyl
ethylbenzyl
ammonium
chloride,
average
molecular
weight
(
in
amu),
377
to
384
None
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
200
ppm
of
active
quaternary
compound
Quaternary
ammonium
compounds
n­
alkyl
(
C12
 
C18)
dimethyl
ethylbenzyl
ammonium
chloride
average
molecular
weight
(
in
amu),
384
None
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
200
ppm
of
active
quaternary
compound
Quaternary
ammonium
compounds
di­
n­
alkyl
(
C8
 
C10)
dimethyl
ammonium
chloride,
average
molecular
weight
(
in
amu),
332
to
361
None
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
150
ppm
of
active
quaternary
compound
Sodium
bicarbonate
144
 
55
 
8
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
120
ppm
Starch
9005
 
25
 
8
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
16
ppm
Sulfuric
acid
monododecyl
ester,
sodium
salt
(
sodium
lauryl
sulfate)
151
 
21
 
3
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
3
ppm
1,3,5­
Triazine­
2,4,6(
1H,
3H,
5H)­
trione,
1,3­
dichloro­,
sodium
salt
2893
 
78
 
9
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
100
ppm
determined
as
total
available
chlorine
(
b)
The
following
chemical
substances
when
used
as
ingredients
in
an
antimicrobial
pesticide
formulation
may
be
applied
to:
Dairy­
processing
equipment
and
food­
processing
equipment
and
utensils.

Pesticide
chemical
CAS
No.
Limits
Acetic
acid
64
 
19
 
7
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
686
ppm
Acetic
acid,
chloro­,
sodium
salt,
reaction
products
with
4,5­
dihydro­
2­
undecyl­
1H­
imidazole­
1­
ethanol
and
sodium
hydroxide
68608
 
66
 
2
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
42
ppm
chloroacetic
acid
Benzenesulfonic
acid,
dodecyl­
27176
 
87
 
0
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
5.5
ppm
Butanedioic
acid,
octenyl­
28805
 
58
 
5
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
156
ppm
Butoxy
monoether
of
mixed
(
ethylene­
propylene)
polyalkylene
glycol,
minimum
average
molecular
weight
(
in
amu),
2400
None
None
Calcium
chloride
10043
 
52
 
4
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
17
ppm
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/
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25,
2003
/
Proposed
Rules
Pesticide
chemical
CAS
No.
Limits
n­
Carboxylic
acids
(
C6
 
C12),
consisting
of
a
mixture
of
not
less
than
56%
octanoic
acid
and
not
less
than
40%
decanoic
acid
None
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
39
ppm
Citric
acid
77
 
92
 
9
None
Decanoic
acid
334
 
48
 
5
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
90
ppm
total
active
fatty
acids
Ethanesulfonic
acid,
2­[
cyclohexyl
(
1­
oxohexadecyl)
amino]­,
sodium
salt
132
 
43
 
4
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
237
ppm
Ethylenediaminetetraacetic
acid
(
EDTA),
disodium
salt
139
 
33
 
3
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
1,400
ppm
FD&
C
Yellow
No.
5
(
conforming
to
21
CFR
74.705)
1934
 
21
 
0
None
D­
Gluconic
acid,
monosodium
salt
527
 
07
 
1
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
760
ppm
Hydriodic
acid
10034
 
85
 
2
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
25
ppm
of
titratable
iodine
Hydrogen
peroxide
7722
 
84
 
1
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
465
ppm
Hypochlorous
acid
7790
 
92
 
3
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
200
ppm
determined
as
total
available
chlorine
Iodine
7553
 
56
 
2
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
25
ppm
of
titratable
iodine
Lactic
acid
50
 
21
 
5
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
138
ppm
a­
Lauroyl­
 ­
hydroxypoly
(
oxyethylene)
with
an
average
of
8
 
9
moles
ethylene
oxide,
average
molecular
weight
(
in
amu),
400
None
None
Nonanoic
acid
112
 
05
 
0
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
90
ppm
1­
Octanamine,
N,
N­
dimethyl­
7378
 
99
 
6
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
113
ppm
1,2­
Octanedisulfonic
acid
113669
 
58
 
2
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
102
ppm
1­
Octanesulfonic
acid
3944
 
72
 
7
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
172
ppm
1­
Octanesulfonic
acid,
sodium
salt
5324
 
84
 
5
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
297
ppm
1­
Octanesulfonic
acid,
2­
sulfino­
113652
 
56
 
5
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
102
ppm
Octanoic
acid
124
 
07
 
2
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
176
ppm
of
total
active
fatty
acids
Oxirane,
methyl­,
polymer
with
oxirane,
ether
with
(
1,2­
ethanediyldinitrilo)
tetrakis[
propanol]
(
4:
1)
11111
 
34
 
5
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
20
ppm
in
the
formulated
product
Oxychloro
species
(
including
chlorine
dioxide)
generated
by
acidification
of
an
aqueous
solution
of
sodium
chlorite
None
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
200
ppm
of
chlorine
dioxide
as
determined
by
the
method
entitled,
``
Iodometric
Method
for
the
Determination
of
Available
Chlorine
Dioxide''
(
50
 
250
ppm
available
chlorine
dioxide)

Peroxyacetic
acid
79
 
21
 
0
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
315
ppm
Peroxyoctanoic
acid
33734
 
57
 
5
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
122
ppm
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/
Vol.
68,
No.
122
/
Wednesday,
June
25,
2003
/
Proposed
Rules
Pesticide
chemical
CAS
No.
Limits
Phosphonic
acid,
(
1­
hydroxyethylidene)
bis­
2809
 
21
 
4
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
34
ppm
Phosphoric
acid
7664
 
38
 
2
None
Phosphoric
acid,
monosodium
salt
7558
 
80
 
7
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
350
ppm
Potassium
iodide
7681
 
11
 
0
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
25
ppm
of
titratable
iodine
Propanoic
acid
79
 
09
 
4
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
297
ppm
2­
Propanol
(
isopropanol)
67
 
63
 
0
2,6­
Pyridinedicarboxylic
acid
499
 
83
 
2
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
1.2
ppm
Sodium
mono­
and
didodecylphenoxy­
benzenedisulfonate
None
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
1,920
ppm
Sulfuric
acid
7664
 
93
 
9
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
288
ppm
Sulfuric
acid
monododecyl
ester,
sodium
salt
(
sodium
lauryl
sulfate)
151
 
21
 
3
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
350
ppm
(
c)
The
following
chemical
substances
when
used
as
ingredients
in
an
antimicrobial
pesticide
formulation
may
be
applied
to:
Food­
processing
equipment
and
utensils.

Pesticide
chemical
CAS
No.
Limits
Acetic
acid
64
 
19
 
7
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
686
ppm
Acetic
acid,
chloro­,
sodium
salt,
reaction
products
with
4,5­
dihydro­
2­
undecyl­
1H­
imidazole­
1­
ethanol
and
sodium
hydroxide
68608
 
66
 
2
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
42
ppm
chloroacetic
acid
a­
Alkyl(
C10
 
C14)­
 ­
hydroxypoly(
oxyethylene)
poly
(
oxypropylene)
average
molecular
weight
(
in
amu),
768
to
837
None
None
a­
Alkyl(
C11
 
C15)­
 ­
hydroxypoly(
oxyethylene)
with
ethylene
oxide
content
9
to
13
moles
None
None
a­
Alkyl(
C12
 
C15)­
 ­
hydroxypoly
(
oxyethylene)
polyoxypropylene,
average
molecular
weight
(
in
amu),
965
None
None
a­
Alkyl(
C12
 
C18)­
 ­
hydroxypoly(
oxyethylene)
poly(
oxypropylene)
average
molecular
weight
(
in
amu),
950
to
1,120
None
None
Alkyl
(
C12
 
C15)
monoether
of
mixed
(
ethylene­
propylene)
polyalkylene
glycol,
cloud
point
of
70
 
77
°
C
in
1%
aqueous
solution,
average
molecular
weight
(
in
amu),
807
None
None
Ammonium
chloride
12125
 
02
 
9
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
48
ppm
Benzenesulfonamide,
N­
chloro­
4­
methyl,
sodium
salt
127
 
65
 
1
None
Benzenesulfonic
acid,
dodecyl­
27176
 
87
 
0
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
400
ppm
Benzenesulfonic
acid,
dodecyl­,
sodium
salt
25155
 
30
 
0
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
430
ppm
Benzenesulfonic
acid,
oxybis[
dodecyl­
30260
 
73
 
2
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
474
ppm
[
1,1'­
Biphenyl]­
2­
ol
90
 
43
 
7
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
400
ppm
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/
Vol.
68,
No.
122
/
Wednesday,
June
25,
2003
/
Proposed
Rules
Pesticide
chemical
CAS
No.
Limits
Boric
acid,
sodium
salt
7775
 
19
 
1
Butanedioic
acid,
octenyl­
28805
 
58
 
5
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
156
ppm
Butanedioic
acid,
sulfo­,
1,4­
dioctyl
ester,
sodium
salt
1639
 
66
 
3
None
Butoxy
monoether
of
mixed
(
ethylene­
propylene)
polyalkylene
glycol,
cloudpoint
of
90
 
100
°
C
in
0.5
aqueous
solution,
average
molecular
weight
(
in
amu),
3,300
None
None
Butoxy
monoether
of
mixed
(
ethylene­
propylene)
polyalkylene
glycol,
minimum
average
molecular
weight
(
in
amu),
2,400
None
None
Calcium
bromide
7789
 
41
 
5
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
200
ppm
total
available
halogen
Calcium
chloride
10043
 
52
 
4
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
17
ppm
n­
Carboxylic
acids
(
C6
 
C12),
consisting
of
a
mixture
of
not
less
than
56%
octanoic
acid
and
not
less
than
40%
decanoic
acid
None
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
39
ppm
Citric
acid
77
 
92
 
9
None
3­
Cyclohexene­
1­
methanol,
a,
a,
4­
trimethyl­
98
 
55
 
5
None
1­
Decanaminium,
N­
decyl­
N,
N­
dimethyl­,
chloride
7173
 
51
 
5
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
200
ppm
of
active
quaternary
compound
Decanoic
acid
334
 
48
 
5
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
234
ppm
total
active
fatty
acids
Dextrin
9004
 
53
 
9
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
16
ppm
Ethanesulfonic
acid,
2­[
cyclohexyl
(
1­
oxohexadecyl)
amino]­,
sodium
salt
132
 
43
 
4
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
237
ppm
Ethanol
64
 
17
 
5
None
Ethanol,
2
butoxy­
111
 
76
 
2
None
Ethanol,
2­(
2­
ethoxyethoxy)­
111
 
90
 
0
None
Ethylenediaminetetraacetic
acid
(
EDTA),
disodium
salt
139
 
33
 
3
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
1,400
ppm
Ethylenediaminetetraacetic
acid
(
EDTA),
tetrasodium
salt
64
 
02
 
8
None
Fatty
acids,
coco,
potassium
salts
61789
 
30
 
8
None
Fatty
acids,
tall­
oil,
sulfonated,
sodium
salts
68309
 
27
 
3
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
66
ppm
FD&
C
Yellow
No.
5
(
conforming
to
21
CFR
74.705)
1934
 
21
 
0
None
D­
Gluconic
acid,
monosodium
salt
527
 
07
 
1
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
760
ppm
Hydriodic
acid
10034
 
85
 
2
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
25
ppm
of
titratable
iodine
Hydrogen
peroxide
7722
 
84
 
1
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
1,100
ppm
Hypochlorous
acid
7790
 
92
 
3
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
200
ppm
determined
as
total
available
chlorine
Hypochlorous
acid,
calcium
salt
7778
 
54
 
3
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
200
ppm
determined
as
total
available
chlorine
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2003
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/
Vol.
68,
No.
122
/
Wednesday,
June
25,
2003
/
Proposed
Rules
Pesticide
chemical
CAS
No.
Limits
Hypochlorous
acid,
lithium
salt
13840
 
33
 
0
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
200
ppm
determined
as
total
available
chlorine
and
30
ppm
lithium
Hypochlorous
acid,
potassium
salt
7778
 
66
 
7
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
200
ppm
determined
as
available
chlorine
Hypochlorous
acid,
sodium
salt
7681
 
52
 
9
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
200
ppm
determined
as
available
chlorine
Iodine
7553
 
56
 
2
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
25
ppm
of
titratable
iodine
Lactic
acid
50
 
21
 
5
None
a­
Lauroyl­
 ­
hydroxypoly
(
oxyethylene)
with
an
average
of
8­
9
moles
ethylene
oxide,
average
molecular
weight
(
in
amu),
400
None
None
Magnesium
oxide
1309
 
48
 
4
None
Methylene
blue
61
 
73
 
4
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
0.4
ppm
Naphthalene
sulfonic
acid,
sodium
salt
1321
 
69
 
3
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
332
ppm
total
naphthalene
sulfonates
Naphthalene
sulfonic
acid
sodium
salt,
and
its
methyl,
dimethyl
and
trimethyl
derivatives
None
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
332
ppm
total
naphthalene
sulfonates
Naphthalene
sulfonic
acid
sodium
salt,
and
its
methyl,
dimethyl
and
trimethyl
derivatives
alkylated
at
3%
by
weight
with
C6
 
C9
linear
olefins
None
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
332
ppm
total
naphthalene
sulfonates
Neodecanoic
acid
26896
 
20
 
8
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
174
ppm
Nonanoic
acid
112
 
05
 
0
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
90
ppm
a­(
p­
Nonylphenyl)­
 ­
hydroxypoly(
oxyethylene)
maximum
average
molecular
weight
(
in
amu),
748
None
None
a­(
p­
Nonylphenol)­
 ­
hydroxypoly(
oxyethylene)
average
poly(
oxyethylene)
content
11
moles
None
None
a­(
p­
Nonylphenyl)­
 ­
hydroxypoly(
oxyethylene)
produced
by
the
condensation
of
1
mole
p­
nonylphenol
with
9
to12
moles
ethylene
oxide
None
None
a­(
p­
Nonylphenyl)­
 ­
hydroxypoly(
oxyethylene),
9
to
13
moles
ethylene
oxide
None
None
Octadecanoic
acid,
calcium
salt
1592
 
23
 
0
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
16
ppm
9­
Octadecenoic
acid
(
9Z)­,
sulfonated
68988
 
76
 
1
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
312
ppm
9­
Octadecenoic
acid
(
9Z)­
sulfonated,
sodium
salts
68443
 
05
 
0
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
200
ppm
1­
Octanamine,
N,
N­
dimethyl­
7378
 
99
 
6
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
113
ppm
1,2­
Octanedisulfonic
acid
113669
 
58
 
2
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
102
ppm
1­
Octanesulfonic
acid
3944­
72
 
7
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
172
ppm
1­
Octanesulfonic
acid,
sodium
salt
5324
 
84
 
5
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
312
ppm
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/
Vol.
68,
No.
122
/
Wednesday,
June
25,
2003
/
Proposed
Rules
Pesticide
chemical
CAS
No.
Limits
1­
Octanesulfonic
acid,
2­
sulfino­
113652
 
56
 
5
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
102
ppm
Octanoic
acid
124
 
07
 
2
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
234
ppm
of
total
active
fatty
acids
Oxirane,
methyl­,
polymer
with
oxirane,
minimum
molecular
weight
(
in
amu),
1,900
9003
 
11
 
6
None
Oxirane,
methyl­,
polymer
with
oxirane,
block,
average
molecular
weight
(
in
amu),
1,900
106392
 
12
 
5
None
Oxirane,
methyl­,
polymer
with
oxirane,
block,
minimum
average
molecular
weight
(
in
amu),
2,000
None
None
Oxirane,
methyl­,
polymer
with
oxirane,
block,
27
to
31
moles
of
polyoxypropylene,
average
molecular
weight
(
in
amu)
2,000
None
None
Oxirane,
methyl­,
polymer
with
oxirane,
ether
with
(
1,2­
ethanediyldinitrilo)
tetrakis[
propanol]
(
4:
1)
11111
 
34
 
5
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
20
ppm
Oxychloro
species
(
predominantly
chlorite,
chlorate
and
chlorine
dioxide
in
an
equilibrium
mixture)
generated
either:
By
directly
metering
a
concentrated
chlorine
dioxide
solution
prepared
just
prior
to
use,
into
potable
water,
or
by
acidification
of
an
aqueous
alkaline
solution
of
oxychloro
species
(
predominately
chlorite
and
chlorate)
followed
by
dilution
with
potable
water
None
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
200
ppm
of
chlorine
dioxide
as
determined
by
the
method
entitled,
``
Iodometric
Method
for
the
Determination
of
Available
Chlorine
Dioxide''
(
50
 
250
ppm
available
chlorine
dioxide)

Oxychloro
species
(
including
chlorine
dioxide)
generated
by
acidification
of
an
aqueous
solution
of
sodium
chlorite
None
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
200
ppm
of
chlorine
dioxide
as
determined
by
the
method
entitled,
``
Iodometric
Method
for
the
Determination
of
Available
Chlorine
Dioxide''
(
50
 
250
ppm
available
chlorine
dioxide)

2,4­
Pentanediol,
2­
methyl­
107
 
41
 
5
None
Peroxyacetic
acid
79
 
21
 
0
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
315
ppm
in
the
formulated
product
Peroxyoctanoic
acid
33734
 
57
 
5
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
122
ppm
Phenol,
4­
chloro­
2­(
phenylmethyl)­
120
 
32
 
1
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
320
ppm
Phenol,
4­(
1,1­
dimethylpropyl)­
80
 
46
 
6
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
80
ppm
Phosphonic
acid,
(
1­
hydroxyethylidene)
bis­
2809
 
21
 
4
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
34
ppm
Phosphoric
acid
7664
 
38
 
2
None
Phosphoric
acid,
monosodium
salt
7558
 
80
 
7
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
350
ppm
Phosphoric
acid,
trisodium
salt
7601
 
54
 
9
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
5916
ppm
in
the
formulated
product
Poly(
oxy­
1,2­
ethanediyl),
a­[(
1,1,3,3­
tetramethylbutyl)
phenyl]­
 ­
hydroxy­,
produced
with
one
mole
of
the
phenol
and
4
to
14
moles
ethylene
oxide
None
None
Potassium
bromide
7758
 
02
 
3
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
200
ppm
total
available
halogen
Potassium
iodide
7681
 
11
 
0
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
25
ppm
of
titratable
iodine
Potassium
permanganate
7722
 
64
 
7
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
0.7
ppm
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FR\
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Federal
Register
/
Vol.
68,
No.
122
/
Wednesday,
June
25,
2003
/
Proposed
Rules
Pesticide
chemical
CAS
No.
Limits
Propanoic
acid
79
 
09
 
4
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
297
ppm
2­
Propanol
(
isopropanol)
67
 
63
 
0
None
2,6­
Pyridinedicarboxylic
acid
499
 
83
 
2
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
1.2
ppm
Quaternary
ammonium
compounds,
alkyl
(
C12
 
C18)
benzyl
dimethyl,
chlorides
8001
 
54
 
5
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
200
ppm
of
active
quaternary
compound
Quaternary
ammonium
compounds,
n­
alkyl
(
C12
 
C14)
dimethyl
ethylbenzyl
ammonium
chloride,
average
molecular
weight
(
in
amu),
377
to
384
None
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
200
ppm
of
active
quaternary
compound
Quaternary
ammonium
compounds,
n­
alkyl
(
C12
 
C18)
dimethyl
ethylbenzyl
ammonium
chloride
average
molecular
weight
(
in
amu)
384
None
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
200
ppm
of
active
quaternary
compound
Quaternary
ammonium
compounds,
di­
n­
Alkyl
(
C8
 
C10)
dimethyl
ammonium
chloride,
average
molecular
weight
(
in
amu),
332
to
361
None
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
240
ppm
of
active
quaternary
compound
Sodium­
a­
alkyl(
C12
 
C15)­
 ­
hydroxypoly
(
oxyethylene)
sulfate
with
the
poly(
oxyethylene)
content
averaging
one
mole
None
None
Sodium
bicarbonate
144
 
55
 
8
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
120
ppm
Sodium
bromide
7647
 
15
 
6
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
200
ppm
total
available
halogen
Sodium
iodide
7681
 
82
 
5
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
25
ppm
of
titratable
iodine
Sodium
mono­
and
didodecylphenoxy­
benzenedisulfonate
None
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
1,920
ppm
Starch
9005
 
25
 
8
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
16
ppm
Sulfuric
acid
7664
 
93
 
9
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
228
ppm
Sulfuric
acid
monododecyl
ester,
sodium
salt
(
sodium
lauryl
sulfate)
151
 
21
 
3
None
1,3,5­
Triazine­
2,4,6(
1H,
3H,
5H)­
trione,
1,3­
dichloro­
2782
 
57
 
2
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
100
ppm
determined
as
total
available
chlorine
1,3,5­
Triazine­
2,4,6(
1H,
3H,
5H)­
trione,
1,3­
dichloro­,
potassium
salt
2244
 
21
 
5
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
100
ppm
determined
as
total
available
chlorine
1,3,5­
Triazine­
2,4,6(
1H,
3H,
5H)­
trione,
1,3­
dichloro­,
sodium
salt
2893
 
78
 
9
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
100
ppm
determined
as
total
available
chlorine
1,3,5­
Triazine­
2,4,6(
1H,
3H,
5H)­
trione,
1,3,5­
trichloro­
87
 
90
 
1
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
100
ppm
determined
as
total
available
chlorine
1,3,5­
Triazine,
N,
N ,
N  ­
trichloro­
2,4,6­
triamino­
7673
 
09
 
8
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
200
ppm
as
total
available
chlorine
Xylenesulfonic
acid,
sodium
salt
1300
 
72
 
7
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
62
ppm
[
FR
Doc.
03
 
16034
Filed
6
 
24
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
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