Document ID: EPA-HQ-OPP-2003-0182-0001
Agency: epa
Document Type: Proposed Rule
Title: Humates; Exemption From the Requirement of a Tolerance
Posted Date: 2003-06-13T04:00Z

35349
Federal
Register
/
Vol.
68,
No.
114
/
Friday,
June
13,
2003
/
Proposed
Rules
ADDRESSES:
Written
comments
should
be
addressed
to
Mr.
Thomas
H.
Diggs,
Chief,
Air
Planning
Section
(
6PD
 
L),
at
the
EPA
Region
6
Office
listed
below.
Copies
of
documents
relevant
to
this
action
are
available
for
public
inspection
during
normal
business
hours
at
the
following
location.
Anyone
wanting
to
examine
these
documents
should
make
an
appointment
with
the
EPA
Region
6
Office.
Environmental
Protection
Agency,
1445
Ross
Avenue,
Suite
700,
Dallas,
Texas
75202
 
2733.

FOR
FURTHER
INFORMATION
CONTACT:
Mr.
Kenneth
W.
Boyce,
Air
Planning
Section
(
6PD
 
L),
Multimedia
Planning
and
Permitting
Division,
U.
S.
EPA,
Region
6,
1445
Ross
Avenue,
Dallas,
Texas
75202,
(
214)
665
 
7259.

SUPPLEMENTARY
INFORMATION:
In
the
``
Rules
and
Regulations''
section
of
this
Federal
Register,
EPA
is
approving
the
submittals
as
a
direct
final
rule
without
prior
proposal
because
EPA
views
this
as
a
noncontroversial
revision
and
anticipates
no
adverse
comment.
The
EPA
has
explained
its
reasons
for
this
approval
in
the
preamble
to
the
direct
final
rule.
If
EPA
receives
no
relevant
adverse
comment,
EPA
will
not
take
further
action
on
this
proposed
rule.
If
EPA
receives
relevant
adverse
comment,
EPA
will
withdraw
the
direct
final
rule
and
it
will
not
take
effect.
The
EPA
will
address
all
public
comments
in
a
subsequent
final
rule
based
on
this
proposed
rule.
The
EPA
will
not
institute
a
second
comment
period
on
this
action.
Any
parties
interested
in
commenting
must
do
so
at
this
time.
Please
note
that
if
EPA
receives
adverse
comment
on
an
amendment,
paragraph,
or
section
of
this
rule
and
if
that
provision
may
be
severed
from
the
remainder
of
the
rule,
EPA
may
adopt
as
final
those
provisions
of
the
rule
that
are
not
the
subject
of
an
adverse
comment.
For
additional
information,
see
the
direct
final
rule
located
in
the
``
Rules
and
Regulations''
section
of
this
Federal
Register.

Authority:
42
U.
S.
C.
7401
et
seq.

Dated:
May
16,
2003.

Lawrence
E.
Starfield,

Deputy
Regional
Administrator,
Region
6.
[
FR
Doc.
03
 
15008
Filed
6
 
12
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0182;
FRL
 
7309
 
7]

Humates;
Exemption
From
the
Requirement
of
a
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Proposed
rule.

SUMMARY:
The
Agency
is
proposing,
on
its
on
initiative,
to
amend
the
existing
tolerance
exemption
for
humic
acid,
sodium
salt
to
include
humic
acid,
potassium
salt
and
humic
acid.
Such
humate
materials
would
be
used
as
inert
ingredients
in
pesticide
formulations
applied
to
growing
crops
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
DATES:
Comments,
identified
by
docket
ID
number
OPP
 
2003
 
0182,
must
be
received
on
or
before
July
14,
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:
Kerry
Leifer,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
8811;
fax
number:
(
703)
305
 
0599;
e­
mail
address:
leifer.
kerry@
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
producttion
(
NAICS
code
111)
 
Animal
production
(
NAICS
code
112)
 
Food
manufacturing
(
NAICS
code
311)
 
Pesticide
manufacturing
(
NAICS
code
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
 
0182.
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
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Federal
Register
/
Vol.
68,
No.
114
/
Friday,
June
13,
2003
/
Proposed
Rules
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
 
0182.
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
 
0182.
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
 
0182.
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
 
0182.
Such
deliveries
are
only
accepted
during
the
docket's
normal
hours
of
operation
as
identified
in
Unit
I.
A.
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.

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/
Vol.
68,
No.
114
/
Friday,
June
13,
2003
/
Proposed
Rules
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.
Background
In
the
Federal
Register
of
April
12,
2000
(
65
FR
19759)
(
FRL
 
6498
 
8),
EPA
issued
a
notice
pursuant
to
section
408
for
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a,
as
amended
by
the
Food
Quality
Protection
Act
(
FQPA)
(
Public
Law
104
 
170)
announcing
the
filing
of
a
pesticide
petition
(
PP
6E4705)
by
LignoTech
USA,
Inc.,
100
Highway
51
South,
Rothschild,
WI
54474
 
1198.
This
notice
included
a
summary
of
the
petition
prepared
by
the
petitioner
LignoTech
USA,
Inc.
This
petition
requested
that
40
CFR
180.1001(
c)
and
(
e)
be
amended
by
establishing
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
humic
acid,
sodium
salt.
Subsequently,
the
petitioner
revised
the
petition
to
request
the
establishment
of
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
humic
acid,
sodium
salt
under
40
CFR
180.1001(
c)
only.
There
were
no
comments
received
in
response
to
the
Notice
of
Filing.
In
the
Federal
Register
of
July
18,
2000
(
65
FR
44469)
(
FRL
 
6595
 
9),
the
Agency
established
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
humic
acid,
sodium
salt
when
used
as
an
inert
ingredient
(
adjuvant,
UV
protectant)
in
pesticide
formulations
applied
to
growing
crops
and
raw
agricultural
commodities
after
harvest.
In
the
Federal
Register
of
March
6,
2002
(
67
FR
10203)
(
FRL
 
6825
 
9),
the
Agency
published
a
Notice
of
Filing
to
amend
the
above
pesticide
petition
6E4705
from
Arctech,
Inc.
located
at
14100
Park
Meadow
Drive,
Chantilly,
VA
20151,
to
amend
the
existing
exemption
from
the
requirement
of
a
tolerance
to
include
residues
of
humic
acid,
potassium
salt
when
used
as
an
inert
ingredient
in
pesticide
formulations
applied
to
growing
crops,
raw
agricultural
commodities
(
RAC)
after
harvest,
or
to
animals.
The
notice
included
a
summary
of
the
petition
prepared
by
the
petitioner,
Arctech,
Inc.
There
were
no
comments
received
in
response
to
this
Notice
of
Filing.

III.
What
Action
is
the
Agency
Taking?
EPA
on
its
own
initiative,
under
section
408(
e)
of
the
FFDCA,
21
U.
S.
C.
346a,
is
proposing
to
establish
an
unlimited
exemption
from
the
requirement
of
a
tolerance
for
residues
of
humic
acid,
sodium
salt
(
CAS
Reg.
No.
68131
 
04
 
04);
humic
acid,
potassium
salt
(
CAS
Reg.
No.
68514
 
28
 
3);
and
humic
acid
(
CAS
Reg.
No.
1415
 
93
 
6)
when
used
as
an
inert
ingredient
in
pesticide
formulations
that
are
applied
to
growing
crops
under
40
CFR
180.1001(
d).
The
Agency
has
not
issued
a
final
rule
on
the
petition
seeking
the
establishment
of
a
tolerance
exemption
for
humic
acid,
potassium
salt,
but
rather
is
issuing
this
proposed
rule
to
amend
the
existing
tolerance
exemption
for
humic
acid,
sodium
salt
to
also
include
humic
acid,
potassium
salt;
and
humic
acid.
Based
on
a
review
and
evaluation
of
the
available
data,
which
includes
a
90
 
day
toxicity
study
using
humic
acid,
the
Agency
believes
that
the
tolerance
exemption
should
also
include
humic
acid,
not
just
the
two
salts,
as
requested
by
the
petitioners.
The
existing
tolerance
exemption
for
humic
acid,
sodium
salt
will
also
be
shifted
from
40
CFR
180.1001(
c)
to
40
CFR
180.1001(
d).
Given
that
the
nature
of
the
substances
considered
are
naturally
occurring
materials,
and
ubiquitous
in
the
environment,
but
essentially,
a
component
of
soil,
the
Agency
believes
that
40
CFR
180.1001(
d),
i.
e.,
application
to
growing
crops
to
be
more
appropriate.
The
Agency
has
determined
that
there
are
no
existing
products
containing
humic
acid,
sodium
salt
having
post­
harvest
uses.
Therefore,
this
action
will
not
have
an
effect
on
any
currently
registered
pesticide
product.
Section
408(
b)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
an
exemption
from
the
requirement
of
a
tolerance
(
the
legal
limit
for
a
pesticide
chemical
residue
in
or
on
a
food)
only
if
EPA
determines
that
the
tolerance
is
``
safe.''
Section
408(
b)(
2)(
A)(
ii)
of
the
FFDCA
defines
``
safe''
to
mean
that
``
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.''
This
includes
exposure
through
drinking
water
and
in
residential
settings,
but
does
not
include
occupational
exposure.
Section
408(
b)(
2)(
C)
of
the
FFDCA
requires
EPA
to
give
special
consideration
to
exposure
of
infants
and
children
to
the
pesticide
chemical
residue
in
establishing
an
exemption
from
the
requirement
of
a
tolerance
and
to
``
ensure
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
the
pesticide
chemical
residue.
.
.
.''
Consistent
with
section
408(
b)(
2)(
D)
of
the
FFDCA,
EPA
has
reviewed
the
available
scientific
data
and
other
relevant
information
in
support
of
this
action.
EPA
has
sufficient
data
to
assess
the
hazards
of
and
to
make
a
determination
on
aggregate
exposure,
consistent
with
section
408(
b)(
2)
of
the
FFDCA,
for
the
establishment
of
an
exemption
from
the
requirement
of
a
tolerance
for
humate
materials.
EPA's
assessment
of
exposures
and
risks
associated
with
establishing
the
exemption
from
the
requirement
of
a
tolerance
follows.

IV.
Toxicological
Profile
EPA
has
evaluated
the
available
toxicity
data
and
considered
its
validity,
completeness,
and
reliability
as
well
as
the
relationship
of
the
results
of
the
studies
to
human
risk.
EPA
has
also
considered
available
information
concerning
the
variability
of
the
sensitivities
of
major
identifiable
subgroups
of
consumers,
including
infants
and
children.
The
nature
of
the
toxic
effects
caused
by
humate
materials
are
discussed
in
this
unit.
Humate
materials
or
humic
substances
occur
naturally
in
the
environment.
They
are
part
of
the
environment
in
which
we
grow
our
food.
The
use
of
the
term
humus
is
said
to
have
occurred
when
Rome
was
an
empire.
The
term
has
also
been
found
in
18th
century
writings.
Humic
substances
are
used
as
soil
conditioners
to
increase
the
amount
of
organic
matter
in
the
soil;
thus,
increasing
the
workability
of
the
soil.
They
are
widely
regarded
as
being
beneficial
to
plants.
The
formation
of
humic
substances
is
not
completely
understood.
It
is
known
that
humic
substances
arise
during
the
decay
of
organic
materials,
which
is
the
reason
that
humic
substances
are
often
associated
with
coal,
lignite,
and
mudstones.
There
are
several
theories
as
to
possible
formation
pathways
(
lignin
theory,
polyphenol
theory,
and
sugaramine
condensation).
Generally,
humic
substances
can
be
further
subdivided
into
three
categories:
humic
acids,
fulvic
acids,
and
humins.
Humic
acid
is
the
major
extractable
component.
With
humates
being
natural
substances,
there
is
some
variation
in
composition
of
the
various
materials.
There
is
some
confusion
as
to
an
exact
definition
of
humic
acid.
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to
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Federal
Register
/
Vol.
68,
No.
114
/
Friday,
June
13,
2003
/
Proposed
Rules
various
information,
humic
acids
are
colloids,
that
behave
somewhat
like
clays.
Humic
acids
are
macromolecules
that
are
soluble
in
dilute
alkali.
They
vary
from
dark
brown
to
black
in
color.
They
are
amorphous,
polymeric
substances
with
molecular
weights
ranging
from
5,000
to
50,000.
The
cation
exchange
capacity
(
the
total
amount
of
exchangeable
cations
a
soil
can
retain)
ranges
from
200
to
500
milliequivalents
per
100
grams
of
soil
at
pH
7.
When
the
cation
exchange
sites
are
mostly
hydrogen,
then
the
material
is
referred
to
as
humic
acid.
When
the
predominant
cation
is
sodium,
then
the
material
is
referred
to
as
humic
acid,
sodium
salt.
Similarly,
material
would
be
referred
to
as
humic
acid,
potassium
salt
if
the
predominant
cation
were
potassium.

A.
Subchronic
Toxicity
The
following
subchronic
toxicity
data
(
National
Technical
Information
Service
(
NTIS)
PB92
 
164946)
was
located
through
an
internet
search
using
humic
as
search
term.
An
abstract
is
located
on
the
National
Library
of
Medicine
Specialized
Information
Services
(
NLM/
SIS).
According
to
the
abstract:
Male
and
female
Sprague­
Dawley
rats
were
administered
drinking
water
containing
humic
acids
either
non­
disinfected
or
following
ozonation
(
O3)
ozonation/
chlorination
(
O32)
for
90
consecutive
days.
Test
animals
drank
either
of
two
concentration
of
humic
acids,
0.25
and
1.0
g/
L
total
organic
carbon
(
TOC),
while
controls
received
phosphate­
buffered,
distilled
water.
No
consistent
significant
treatment­
related
effects
were
observed
in
body
weight
gain,
organ
weights,
food
or
water
consumption,
or
hematological
and
clinical
chemistry
parameters.
No
target
organs
were
identified
from
the
histopathological
examination
of
the
tissues.
The
most
significant
observation,
an
increase
in
liver
to
body
weight
ratio
for
the
male
animals
in
the
1.0
g/
LO3/
CL2
humic
acid
group,
was
not
observed
in
any
other
group,
nor
was
it
corroborated
via
any
biochemical
measurements
or
histopathological
analysis.

B.
Mutagenicity
An
abstract
discussing
the
mutagenicity
of
two
coal­
derived
humic
substances
(
Sulcis
and
South
Africa,
Eniricerche,
Italy)
was
located
through
the
NLM/
SIS.
Their
mutagenic
activity
on
TA98
and
TA100
Salmonella
typhimurium
strains,
both
in
the
presence
or
the
absence
of
metabolic
acitivation
(
S9)
was
discussed.
Both
compounds
showed
no
effect
on
the
two
strains,
as
observed
with
natural
humic
acid.
V.
Aggregate
Exposures
In
examining
aggregate
exposure,
FFDCA
section
408
directs
EPA
to
consider
available
information
concerning
exposures
from
the
pesticide
residue
in
food
and
all
other
nonoccupational
exposures,
including
drinking
water
from
ground
water
or
surface
water
and
exposure
through
pesticide
use
in
gardens,
lawns,
or
buildings
(
residential
and
other
indooor
uses).
EPA
establishes
exemptions
from
the
requirement
of
tolerances
only
in
those
cases
where
it
can
be
demonstrated
that
the
risks
from
aggregate
exposure
to
pesticide
chemical
residues
under
reasonable
foreseeable
circumstances
will
pose
no
appreciable
risks
to
human
health.
In
order
to
determine
the
risks
from
aggregate
exposure
to
pesticide
inert
ingredients,
the
Agency
considers
the
toxicity
of
the
inert
in
conjunction
with
possible
exposure
to
residues
of
the
inert
ingredient
through
food,
drinking
water,
and
through
other
exposures
that
occur
as
a
result
of
pesticide
use
in
residential
settings.
If
EPA
is
able
to
determine
that
a
finite
tolerance
is
not
necessary
to
ensure
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
inert
ingredient,
an
exemption
from
the
requirement
of
tolerance
may
be
established.

A.
Dietary
Exposure
1.
Food.
Not
only
are
humic
substances
abundant
in
nature,
but
they
have
been
used
in
commercial
agriculture
for
years
to
condition
soils.
Therefore,
there
is
likely
a
substantial
ongoing
human
dietary
exposure
to
humate
materials
from
these
sources
and
increased
dietary
exposures
from
the
use
of
humate
materials
as
an
inert
ingredient
in
pesticide
formulations
is
expected
to
be
minimal.
2.
Drinking
water
exposure.
Humic
substances
occur
in
abundance
in
nature,
including
soils,
fresh
water,
and
oceans.
Increased
drinking
water
exposure
from
the
use
of
humate
materials
in
pesticide
formulations
would
not
be
expected.

B.
Other
Non­
Occupational
Exposure
Humic
substances
occur
in
abundance
in
nature,
including
soils
that
are
in
and
around
the
home.
The
potential
for
an
increase
in
the
existing
non­
dietary
exposure
to
the
general
population,
including
infants
and
children,
is
unlikely
as
these
pestcide
formulations
containing
humate
materials
would
be
used
in
agricultural
and
horticultural
settings.
VI.
Cumulative
Effects
Section
408(
b)(
2)(
v)
of
FFDCA
requires
that,
when
considering
whether
to
establish,
modify
or
revoke
a
tolerance
or
tolerance
exemption,
the
Agency
consider
``
available
information''
concerning
the
cumulative
effects
of
particular
chemical's
residues
and
``
other
substances
that
have
a
common
mechanism
of
toxicity.''
The
Agency
has
not
made
any
conclusions
as
to
whether
or
not
humic
acid,
potassium
salt
shares
a
common
mechanism
of
toxicity
with
other
chemicals.
However,
humic
acid,
potasssium
salt
is
expected
to
be
practically
non­
toxic
to
mammals.
Due
to
the
expected
lack
of
toxicity,
a
cumulative
risk
assessment
is
not
necessary.

VII.
Determination
of
Safety
for
U.
S.
Population,
Infants,
and
Children
Humic
substances
are
present
in
abundance
in
the
soil
and
the
environment.
Humic
substances
have
been
used
in
commercial
agriculture
for
years
to
condition
soils.
Based
on
available
information
on
these
chemically
related
substances,
the
Agency
believes
that
humic
acid;
humic
acid,
postassium
salt;
and
humic
acid,
sodium
salt
are
practically
non
toxic
to
mammals.
Due
to
the
ubiquitous
nature
of
these
naturally
occurring
materials,
and
the
high
molecular
weights
of
the
humic
materials,
no
chronic
or
acute
effects
are
expected
to
occur.
There
is
no
available
information
to
indicate
that
these
naturally
occurring
substances
are
carcinogenic,
mutagenic,
or
expected
to
have
any
effect
on
the
immune
or
endocrine
systems.
Because
of
its
abundance
in
nature
and
lack
of
toxicity,
the
Agency
did
not
use
the
safety
factor
analysis
in
evaluating
the
risk
posed
by
humate
substances
and
did
not
apply
an
additional
tenfold
safety
factor
to
protect
infants
and
children.
Based
on
the
information
in
the
preamble,
EPA
concludes
that
there
is
a
reasonable
certainty
of
no
harm
from
aggregate
exposure
to
residues
of
humic
acid;
humic
acid,
potassium
salt;
and
humic
acid,
sodium
salt.
Accordingly,
EPA
finds
that
exempting
these
humate
materials
from
the
requirement
of
a
tolerance
will
be
safe.

IX.
Other
Considerations
A.
Endocrine
Disruptors
FQPA
requires
EPA
to
develop
a
screening
program
to
determine
whether
certain
substances,
including
all
pesticide
chemicals
(
both
inert
and
active
ingredients),
``
may
have
an
effect
in
humans
that
is
similar
to
an
effect
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Federal
Register
/
Vol.
68,
No.
114
/
Friday,
June
13,
2003
/
Proposed
Rules
produced
by
a
naturally
occuring
estrogen,
or
such
other
endocrine
effect....''
EPA
has
been
working
with
interested
stakeholders
to
develop
a
screening
and
testing
program
as
well
as
a
priority
setting
scheme.
As
the
Agency
proceeds
with
implementation
of
this
program,
further
testing
of
products
containing
humic
acid,
potassium
salt
for
endocrine
effects
may
be
required.

B.
Analytical
Method(
s)
An
analytical
method
is
not
required
for
enforcement
purposes
since
the
Agency
is
establishing
an
exemption
from
the
requirement
of
a
tolerance
without
any
numerical
limitation.

C.
Existing
Exemptions
An
exemption
from
the
requirement
of
a
tolerance
does
exist
for
humic
acid,
sodium
salt
(
40
CFR
180.1001(
c))
for
use
as
an
adjuvant,
UV
protectant.

D.
International
Tolerances
The
Agency
is
not
aware
of
any
country
requiring
a
tolerance
for
humic
substances
nor
have
any
CODEX
Maximum
Residue
Levels
(
MRLs)
been
established
for
any
food
crops
at
this
time.

X.
Conclusions
Based
on
the
information
in
this
preamble,
EPA
concludes
that
there
is
a
reasonable
certainty
of
no
harm
from
aggregate
exposure
to
residues
of
humic
acid;
humic
acid,
potassium
salt;
and
humic
acid,
sodium
salt.
Accordingly,
EPA
finds
that
exempting
humate
materials
from
the
requirement
of
a
tolerance
will
be
safe.

XI.
Statutory
and
Executive
Order
Reviews
This
proposed
rule
establishes
a
consolidated
and
expanded
exemption
from
the
requirement
for
a
tolerance
under
section
408(
d)
of
the
FFDCA.
The
Office
of
Management
and
Budget
(
OMB)
has
exempted
these
types
of
actions
from
review
under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993).
Because
this
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
contain
any
information
collections
subject
to
OMB
approval
under
the
Paperwork
Reduction
Act
(
PRA),
44
U.
S.
C.
3501
et
seq.,
or
impose
any
enforceable
duty
or
contain
any
unfunded
mandate
as
described
under
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
UMRA)
(
Public
Law
104
 
4).
Nor
does
it
require
any
special
considerations
under
Executive
Order
12898,
entitled
Federal
Actions
to
Address
Environmental
Justice
in
Minority
Populations
and
Low­
Income
Populations
(
59
FR
7629,
February
16,
1994);
or
OMB
review
or
any
Agency
action
under
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997).
This
action
does
not
involve
any
technical
standards
that
would
require
Agency
consideration
of
voluntary
consensus
standards
pursuant
to
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
NTTAA),
Public
Law
104
 
113,
section
12(
d)
(
15
U.
S.
C.
272
note).
The
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et
seq.)
generally
requires
an
agency
to
prepare
a
regulatory
flexibility
analysis
of
any
rule
subject
to
notice
and
comment
rulemaking
requirements
under
the
Administrative
Procedure
Act
or
any
other
statute
unless
the
agency
certifies
that
the
rule
will
not
have
a
significant
impact
on
a
substantial
number
of
small
entities.
Small
entities
include
small
businesses,
small
organizations,
and
small
governmental
organizations.
After
considering
the
economic
impacts
of
today's
proposed
rule
on
small
entities,
I
certify
that
this
action
will
not
have
a
significant
economic
impact
on
a
substantial
number
of
small
entities.
Establishing
an
exemption
from
the
requirement
of
a
pesticide
tolerance
(
or,
expanding
and
consolidating
a
tolerance
exemption,
as
is
proposed
today),
is
in
effect,
the
removal
of
a
regulatory
restriction
on
pesticide
residues
in
food
and
thus
such
an
action
will
not
have
any
negative
economic
impact
on
any
entities,
including
small
entities.
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.

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Federal
Register
/
Vol.
68,
No.
114
/
Friday,
June
13,
2003
/
Proposed
Rules
List
of
Subjects
in
40
CFR
Part
180
Environmental
protection,
Administrative
practice
and
procedure,
Agricultural
commodities,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.

Dated:
June
4,
2003.
Peter
Caulkins,
Acting
Director,
Registration
Division,
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),
346(
a)
and
371.

2.
Section
180.1001
is
amended
as
follows:
i.
The
table
to
paragraph
(
c)
is
amended
by
removing
the
entry
for
``
humic
acid,
sodium
salt.''
ii.
The
table
in
paragraph
(
d)
is
amended
by
adding
alphabetically
three
inert
ingredients
to
read
as
follows:

§
180.1001
Exemptions
from
the
requirement
of
a
tolerance.

*
*
*
*
*
(
d)
*
*
*

Inert
ingredients
Limits
Uses
*
*
*
*
*
*
*
Humic
Acid,
CAS
Reg.
No.
1415
 
93
......................................
.................................
Adjuvant,
UV
Protectant
Humic
Acid,
Potassium
salt
CAS
Reg.
No.
68514
 
28
 
3
.......
.................................
Adjuvant,
UV
Protectant
Humic
Acid,
Sodium
Salt
CAS
Reg.
No.
68131
 
04
 
4
...........
.................................
Adjuvant,
UV
Protectant
*
*
*
*
*
*
*

[
FR
Doc.
03
 
14881
Filed
6
 
12
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
DEPARTMENT
OF
TRANSPORTATION
National
Highway
Traffic
Safety
Administration
49
CFR
Part
571
[
Docket
No.
03
 
14483,
Notice
No.
2]

RIN
2127
 
AH79
Federal
Motor
Vehicle
Safety
Standards;
Brake
Hoses;
Correction
AGENCY:
National
Highway
Traffic
Safety
Administration
(
NHTSA),
Department
of
Transportation
(
DOT).
ACTION:
Notice
of
proposed
rulemaking;
correction.

SUMMARY:
This
document
corrects
a
Notice
of
Proposed
Rulemaking
(
NPRM)
published
in
the
Federal
Register
on
May
15,
2003.
The
NPRM
proposed
to
update
the
Federal
motor
vehicle
safety
standard
on
brake
hoses
to
incorporate
the
substantive
specifications
of
several
Society
of
Automotive
Engineers
(
SAE)
Recommended
Practices
relating
to
hydraulic
brake
hoses,
vacuum
brake
hoses,
air
brake
hoses,
and
plastic
air
brake
tubing.
This
correction
adds
a
proposed
effective
date
to
the
preamble.

FOR
FURTHER
INFORMATION
CONTACT:
George
Feygin
at
(
202)
366
 
3992.

Correction
In
the
notice
of
proposed
rulemaking
FR
Doc.
03
 
11292
(
68
FR
26384)
make
the
following
correction.
On
page
26406
in
the
first
column,
add,
before
the
beginning
of
the
first
paragraph
the
following:
``
Effective
Date
The
agency
believes
that
most,
if
not
all,
hoses,
tubing,
and
fittings
affected
by
Standard
No.
106
are
already
designed
to
meet
the
SAE
specifications
we
are
proposing
to
add
to
the
standard.
The
agency
is
proposing
that
compliance
with
the
updated
version
of
the
standard
become
mandatory
two
years
after
publication
of
the
final
rule.
NHTSA
believes
that
this
date
will
provide
manufacturers
with
sufficient
leadtime
to
redesign
the
small
proportion
of
brake
hose
products
that
may
need
modification.''

Issued:
June
6,
2003.
Stephen
R.
Kratzke,
Associate
Administrator
for
Rulemaking.
[
FR
Doc.
03
 
14865
Filed
6
 
12
 
03;
8:
45
am]

BILLING
CODE
4910
 
59
 
P
DEPARTMENT
OF
COMMERCE
National
Oceanic
and
Atmospheric
Administration
50
CFR
Part
660
[
Docket
No.
030602142
 
3142
 
01;
I.
D.
051403C]

RIN
0648
 
AQ68
Fisheries
Off
West
Coast
States
and
in
the
Western
Pacific;
Pacific
Coast
Groundfish
Fishery;
Amendment
17
AGENCY:
National
Marine
Fisheries
Service
(
NMFS),
National
Oceanic
and
Atmospheric
Administration
(
NOAA),
Commerce.
ACTION:
Proposed
rule;
request
for
comments.

SUMMARY:
NMFS
issues
this
proposed
rule
to
implement
Amendment
17
to
the
Pacific
Coast
Groundfish
Fishery
Management
Plan
(
FMP).
Amendment
17
would
revise
the
Pacific
Fishery
Management
Council's
(
Council's)
annual
groundfish
management
process
so
that
it
would
become
a
biennial
process.
Amendment
17
is
intended
to
ensure
that
the
specifications
and
management
measures
process
comports
with
a
Court
ruling,
to
make
the
Council's
development
process
for
specifications
and
management
measures
more
efficient
so
that
more
time
is
available
for
other
management
activities,
and
to
streamline
the
NMFS
regulatory
process
for
implementing
the
specifications
and
management
measures.

DATES:
Comments
must
be
submitted
in
writing
by
July
28,
2003.
ADDRESSES:
Comments
on
Amendment
17
or
supporting
documents
should
be
sent
to
D.
Robert
Lohn,
Administrator,
Northwest
Region,
NMFS,
Sand
Point
Way
NE.,
BIN
C15700,
Seattle,
WA
98115
 
0070.
Copies
of
Amendment
17
and
the
environmental
assessment/
regulatory
impact
review/
initial
regulatory
flexibility
analysis
(
EA/
RIR/
IRFA)
are
available
from
Donald
McIsaac,
Executive
Director,
Pacific
Fishery
Management
Council,
2130
SW
Fifth
Ave.,
Suite
224,
Portland,
OR
97201.

FOR
FURTHER
INFORMATION
CONTACT:
Yvonne
deReynier
(
Northwest
Region,
NMFS),
phone:
206
 
526
 
6140;
fax:
206
 
526
 
6736
and;
e­
mail:
yvonne.
dereynier@
noaa.
gov.

SUPPLEMENTARY
INFORMATION:

Electronic
Access
This
Federal
Register
document
is
also
accessible
via
the
Internet
at
the
website
of
the
Office
of
the
Federal
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