Document ID: EPA-HQ-OW-2003-0006-0001
Agency: epa
Document Type: Notice
Title: Standards for the Use or Disposal of Sewage Sludge; Agency Response to the National Research Council Report on Biosolids Applied to Land and the Results of EPA's Review of Existing Sewage Sludge Regulations; Notice, with request for comment.
Posted Date: 2003-04-09T04:00Z

17379
Federal
Register
/
Vol.
68,
No.
68
/
Wednesday,
April
9,
2003
/
Notices
of
the
complete
application.
To
receive
EPA
approval,
a
State
or
Tribe
must
demonstrate
that
its
program
is
at
least
as
protective
of
human
health
and
the
environment
as
the
Federal
program,
and
provides
for
adequate
enforcement
(
section
404(
b)
of
TSCA,
15
U.
S.
C.
2684
(
b)).
EPA's
regulations
(
40
CFR
part
745,
subpart
Q)
provide
the
detailed
requirements
a
State
or
Tribal
program
must
meet
in
order
to
obtain
EPA
authorization.
A
State
may
choose
to
certify
that
its
lead­
based
paint
activities
program
meets
the
requirements
for
EPA
authorization,
by
submitting
a
letter
signed
by
the
Governor
or
the
Attorney
General
stating
that
the
program
meets
the
requirements
of
section
404(
b)
of
TSCA.
Upon
submission
of
such
certification
letter,
the
program
is
deemed
authorized
until
such
time
as
EPA
disapproves
the
program
application
or
withdrawals
the
program
authorization.
In
accordance
with
40
CFR
745.324(
d),
``
Program
Certification,''
the
Governor
of
North
Dakota
submitted
a
self­
certification
letter
to
the
EPA
Administrator
on
September
26,
2002,
certifying
that
the
State
program
meets
the
requirements
contained
in
40
CFR
745.324(
e)(
2)(
i)
and
(
e)(
2)(
ii).
Included
in
the
application
was
a
letter
from
the
Attorney
General
of
North
Dakota,
certifying
that
the
laws
and
regulations
of
the
State
provided
adequate
legal
authority
to
administer
and
enforce
TSCA
section
402.
Notice
of
North
Dakota's
application,
a
solicitation
for
public
comment
regarding
the
application
was
published
in
the
Federal
Register
of
January
8,
2003
(
68
FR
1059)
(
FRL
 
7282
 
8).
As
determined
by
EPA's
review
and
assessment,
North
Dakota's
application
successfully
demonstrated
that
the
State's
Lead­
Based
Paint
Activities
Program
achieves
the
protectiveness
and
enforcement
criteria,
as
required
for
Federal
authorization.
Furthermore,
no
public
comments
were
received
regarding
North
Dakota's
application.
Therefore,
as
of
September
26,
2002,
the
State
of
North
Dakota
is
authorized
to
administer
and
enforce
the
lead­
based
paint
program
under
TSCA
section
402.

II.
Federal
Overfiling
TSCA
section
404(
b)
(
15
U.
S.
C.
2684(
b))
makes
it
unlawful
for
any
person
to
violate,
or
fail
or
refuse
to
comply
with,
any
requirement
of
an
approved
State
or
Tribal
program.
Therefore,
EPA
reserves
the
right
to
exercise
its
enforcement
authority
under
TSCA
against
a
violation
of,
or
a
failure
or
refusal
to
comply
with,
any
requirement
of
an
authorized
State
or
Tribal
program.

III.
Withdrawal
of
Authorization
Pursuant
to
TSCA
section
404(
c),
the
Administrator
may
withdraw
a
State
or
Tribal
lead­
based
paint
activities
program
authorization,
after
notice
and
opportunity
for
corrective
action,
if
the
program
is
not
being
administered
or
enforced
in
compliance
with
standards,
regulations,
and
other
requirements
established
under
the
authorization.
The
procedures
EPA
will
follow
for
the
withdrawal
of
an
authorization
are
found
at
40
CFR
745.324(
i).

IV.
Congressional
Review
Act
The
Congressional
Review
Act,
5
U.
S.
C.
801
as
amended
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996,
generally
provides
that
before
certain
actions
may
take
effect,
the
agency
promulgating
the
action
must
submit
a
report,
which
includes
a
copy
of
the
action,
to
each
House
of
the
Congress
and
to
the
Comptroller
General
of
the
United
States.
EPA
will
submit
a
report
containing
this
action
and
other
required
information
to
the
U.
S.
Senate,
the
U.
S.
House
of
Representatives,
and
the
Comptroller
General
of
the
United
States
prior
to
publication
of
this
document
in
the
Federal
Register.
This
action
is
not
a
``
major
rule''
as
defined
by
5
U.
S.
C.
804(
2).

List
of
Subjects
Environmental
protection,
Hazardous
substances,
Lead,
Reporting
and
recordkeeping
requirements.

Dated:
March
28,
2003.
Robert
E.
Roberts,
Regional
Administrator,
Region
VIII.
[
FR
Doc.
03
 
8657
Filed
4
 
8
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
FRL
 
7478
 
7]

Standards
for
the
Use
or
Disposal
of
Sewage
Sludge;
Agency
Response
to
the
National
Research
Council
Report
on
Biosolids
Applied
to
Land
and
the
Results
of
EPA's
Review
of
Existing
Sewage
Sludge
Regulations
AGENCY:
Environmental
Protection
Agency.
ACTION:
Notice,
with
request
for
comment.

SUMMARY:
The
Environmental
Protection
Agency
is
providing
notice
and
requesting
public
comment
on
the
Agency's
preliminary
review
of
regulations
under
the
Clean
Water
Act
governing
the
use
and
disposal
of
sewage
sludge.
As
part
of
this
review,
EPA
commissioned
the
National
Research
Council
(
NRC)
of
the
National
Academy
of
Sciences
to
independently
review
the
technical
basis
of
the
chemical
and
pathogen
regulations
applicable
to
sewage
sludge
that
is
applied
to
land.
In
July
2002,
the
NRC
published
a
report
entitled
``
Biosolids
Applied
to
Land:
Advancing
Standards
and
Practices''
in
response
to
the
EPA's
request.
Today,
the
Agency
is
also
announcing
a
strategy
explaining
how
EPA
plans
to
respond
to
the
recommendations
in
the
NRC
report.
Today's
notice
explains
the
rationale
for
the
strategy
and
solicits
public
comments
on
the
strategy.
In
addition,
EPA
is
announcing
the
preliminary
results
of
its
review
of
existing
sewage
sludge
regulations
under
the
Clean
Water
Act.
At
this
time,
EPA
has
not
identified
any
additional
toxic
pollutants
that
warrant
regulation
in
sewage
sludge.
The
next
step
in
identifying
chemicals
that
may
warrant
regulation
is
to
conduct
a
screening
analysis
of
those
chemicals
for
which
adequate
data
and
analytical
methods
are
available
and
for
which
there
is
evidence
that
they
may
occur
in
sewage
sludge.
EPA
plans
to
complete
this
screening
analysis
by
January
2004.
The
terms
``
sewage
sludge''
and
``
biosolids''
are
used
interchangeably
in
this
notice.
DATES:
EPA
requests
comments
on
all
aspects
of
this
notice.
If
you
wish
to
submit
comments
on
this
action,
you
must
do
so
by
July
8,
2003.
ADDRESSES:
Send
your
comments
to:
Water
Docket,
Environmental
Protection
Agency,
Mailcode:
4101T,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460,
Attention
Docket
ID
No.
OW
 
2003
 
0006.
Comments
may
also
be
submitted
electronically
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
for
providing
comments
in
section
B
of
the
SUPPLEMENTARY
INFORMATION
section.

FOR
FURTHER
INFORMATION
CONTACT:
Arleen
Plunkett,
U.
S.
Environmental
Protection
Agency,
Office
of
Water,
Health
and
Ecological
Criteria
Division
(
4304T),
1200
Pennsylvania
Avenue,
NW.,
Washington,
DC
20460.
(
202)
566
 
1119.
plunkett.
arleen@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
Additional
Docket
Information
A.
How
Can
I
Get
Copies
of
This
Document
and
Other
Related
Information?

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
VerDate
Jan<
31>
2003
17:
05
Apr
08,
2003
Jkt
200001
PO
00000
Frm
00045
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
09APN1.
SGM
09APN1
17380
Federal
Register
/
Vol.
68,
No.
68
/
Wednesday,
April
9,
2003
/
Notices
under
Docket
ID
No.
OW
 
2003
 
0006.
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
are
available
for
public
viewing
at
the
Water
Docket
in
the
EPA
Docket
Center,
(
EPA/
DC)
EPA
West,
Room
B102,
1301
Constitution
Ave.,
NW.,
Washington,
DC.
The
EPA
Docket
Center
Public
Reading
Room
is
open
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Public
Reading
Room
is
(
202)
566
 
1744,
and
the
telephone
number
for
the
Water
Docket
is
(
202)
566
 
2426.
2.
Electronic
Access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the
``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
identification
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.
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
section
A.
1.
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.
For
additional
information
about
EPA's
electronic
public
docket
visit
EPA
Dockets
online
or
see
67
FR
38102,
May
31,
2002.

B.
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
identification
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
late
comments.

1.
Electronically
If
you
submit
an
electronic
comment
as
prescribed
below,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
e­
mail
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
No.
OW
 
2003
 
0006.
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
electronic
mail
(
e­
mail)
to
ow­
docket@
epa.
gov,
Attention
Docket
ID
No.
OW
 
2003
 
0006.
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
email
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
section
B.
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:
Water
Docket,
Environmental
Protection
Agency,
Mailcode:
4101T,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460,
Attention
Docket
ID
No.
OW
 
2003
 
0006.
3.
By
Hand
Delivery
or
Courier.
Deliver
your
comments
to:
EPA
Docket
Center,
(
EPA/
DC)
EPA
West,
Room
B102,
1301
Constitution
Ave.,
NW.,
Washington,
DC
20460,
Attention
Docket
ID
No.
OW
 
2003
 
0006.
Such
deliveries
are
only
accepted
during
the
Docket's
normal
hours
of
operation
as
identified
in
section
A.
1.

C.
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.

VerDate
Jan<
31>
2003
15:
16
Apr
08,
2003
Jkt
200001
PO
00000
Frm
00046
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
09APN1.
SGM
09APN1
17381
Federal
Register
/
Vol.
68,
No.
68
/
Wednesday,
April
9,
2003
/
Notices
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
a
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
identification
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.
Abbreviations
and
Acronyms
Used
AMSA
 
Association
of
Metropolitan
Sewerage
Agencies
BDMS
 
Biosolids
Data
Management
System
CAFO
 
Concentrated
Animal
Feeding
Operations
CDC
 
Centers
for
Disease
Control
and
Prevention
CFR
 
Code
of
Federal
Regulations
CWA
 
Clean
Water
Act
EC
 
European
Community
EMS
 
Environmental
Management
System
EPA
 
U.
S.
Environmental
Protection
Agency
EQ
 
Exceptional
Quality
EU
 
European
Union
FTIR
 
Fourier
Transform
Infrared
GC/
MS
 
Gas
Chromatography/
Mass
Spectrometry
IAC
 
EPA
Intra­
Agency
Committee
for
Biosolids
ICMA
 
International
City/
County
Management
Association
IRIS
 
Integrated
Risk
Information
System
ISG
 
Information
Sharing
Group
LGEAN
 
Local
Government
Environmental
Assistance
Network
NBP
 
National
Biosolids
Partnership
NEBRA
 
New
England
Biosolids
and
Residuals
Association
NPDES
 
National
Pollutant
Discharge
Elimination
System
NODA
 
Notice
of
Data
Availability
NRC
 
National
Research
Council
NSSS
 
National
Sewage
Sludge
Survey
ORD
 
Office
of
Research
and
Development
OW
 
Office
of
Water
PA
 
State
of
Pennsylvania
PCBs
 
Polychlorinated
biphenyls
PCDDs/
Fs
 
Polychlorinated
dibenzo­
pdioxins
dibenzofurans
PCS
 
Permit
Compliance
System
PEC
 
EPA's
Pathogen
Equivalency
Committee
POTW­
Publicly
Owned
Treatment
Works
PFRP
 
Processes
to
Further
Reduce
Pathogens
PSRP
 
Processes
to
Significantly
Reduce
Pathogens
QA/
QC
 
Quality
Assurance/
Quality
Control
QMRA
 
Quantitative
Microbial
Risk
Assessment
RME
 
Reasonable
Maximum
Exposure
SSI
 
Sewage
Sludge
Incinerator
UA
 
University
of
Arizona,
Water
Quality
Center
UCAL
 
University
of
California
UPA
 
University
of
Pennsylvania
USDA
 
United
States
Department
of
Agriculture
WEF
 
Water
Environment
Federation
WERF
 
Water
Environmental
Research
Foundation
Table
of
Contents
I.
What
is
the
Legal
Background
of
the
Standards
for
the
Use
or
Disposal
of
Sewage
Sludge?
II.
What
Requirements
are
Included
in
the
Standards
for
the
Use
or
Disposal
of
Sewage
Sludge
(
40
CFR
Part
503)?
III.
What
is
the
Purpose
of
Today's
Notice?
IV.
What
was
EPA's
Charge
to
the
National
Research
Council?
V.
What
Were
the
National
Research
Council's
Major
Findings
and
Recommendations
Concerning
Land
Application
of
Biosolids?
VI.
What
Process
did
EPA
Use
to
Address
the
NRC
recommendations?
VII.
EPA's
Strategy
for
Responding
to
the
NRC
Recommendations
VIII.
EPA
Responses
to
the
NRC
Recommendations
by
Category
IX.
How
did
EPA
Conduct
the
Review
of
Part
503
Regulations
under
the
CWA
Section
405(
d)(
2)(
C)?
X.
What
are
the
Primary
Issues
for
Public
Comment?
XI.
References
I.
What
Is
the
Legal
Background
of
the
Standards
for
the
Use
or
Disposal
of
Sewage
Sludge?

EPA
promulgated
Standards
for
the
Use
or
Disposal
of
Sewage
Sludge
(
40
CFR
part
503)
under
section
405(
d)
and
(
e)
of
the
Clean
Water
Act
(
CWA),
33
U.
S.
C.
section
1345(
d),
(
e),
as
amended
by
the
Water
Quality
Act
of
1987.
In
these
amendments
to
section
405
of
the
CWA,
Congress,
for
the
first
time,
set
forth
a
comprehensive
program
for
reducing
the
potential
environmental
risks
and
maximizing
the
beneficial
use
of
sewage
sludge.
As
amended,
section
405(
d)
of
the
CWA
requires
EPA
to
establish
numerical
limits
and
management
practices
that
protect
public
health
and
the
environment
from
the
reasonably
anticipated
adverse
effects
of
toxic
pollutants
in
sewage
sludge.
Section
405(
e)
prohibits
any
person
from
disposing
of
sewage
sludge
from
publicly
owned
treatment
works
(
POTW)
or
other
treatment
works
treating
domestic
sewage
for
any
use
except
in
compliance
with
regulations
promulgated
under
section
405.
Section
405(
d)
calls
for
two
rounds
of
sewage
sludge
regulations
and
sets
deadlines
for
promulgation.
In
the
first
round,
EPA
was
to
establish
numerical
limits
and
management
practices
for
those
toxic
pollutants
which,
based
on
``
available
information
on
their
toxicity,
persistence,
concentration,
mobility,
or
potential
for
exposure,
may
be
present
in
sewage
sludge
in
concentrations
that
may
adversely
affect
public
health
or
the
environment.''
CWA
section
405(
d)(
2)(
A).
The
second
round
is
to
address
toxic
pollutants
not
regulated
in
the
first
round
``
which
may
adversely
affect
public
health
or
the
environment.''
CWA
section
405(
d)(
2)(
B).
EPA
did
not
meet
the
timetable
in
section
405(
d)
for
promulgating
the
first
round
of
regulations,
and
a
citizen's
suit
was
filed
to
require
EPA
to
fulfill
this
mandate,
(
Gearhart
v.
Reilly,
Civ.
No.
89
 
6266
 
HO
(
D.
Ore.)).
A
consent
decree
was
entered
by
the
court
in
this
case,
establishing
schedules
for
both
rounds
of
sewage
sludge
rules.
EPA
promulgated
the
first
rule
in
1993,
40
CFR
part
503.
58
FR
9248
(
Feb.
19,
1993)
(``
Round
One'').
For
the
second
round
(``
Round
Two''),
EPA
identified
31
pollutants
and
pollutant
categories
not
regulated
in
Round
One
that
EPA
was
considering
for
regulation.
In
November
1995,
EPA
narrowed
the
original
list
of
31
pollutants
to
two
pollutant
groups
for
the
second
round
rulemaking:
polychlorinated
dibenzo­
pdioxins
dibenzofurans
(
PCDDs/
Fs)
and
dioxin­
like
coplanar
polychlorinated
biphenyls
(
PCBs)
(
USEPA,
1996).
The
consent
decree
required
the
Administrator
to
sign
a
notice
for
publication
proposing
Round
Two
regulations
no
later
than
December
15,
1999,
and
to
sign
a
notice
taking
final
action
on
the
proposal
no
later
than
December
15,
2001.
(
Gearhart
v.
Whitman,
Civ.
No.
89
 
6266
 
HO
(
D.
Ore.)).
On
December
15,
1999,
the
Administrator
signed
a
proposal
to
establish
numerical
limits
for
dioxins,
dibenzofurans,
and
co­
planar
PCBs
(``
dioxins'')
in
sewage
sludge
that
is
applied
to
the
land
and
proposed
not
to
regulate
dioxins
in
sewage
sludge
that
is
disposed
of
in
a
surface
disposal
unit
or
fired
in
a
sewage
sludge
incinerator.
64
FR
72045
(
December
23,
1999).
On
December
21,
2001,
the
Administrator
gave
final
notice
of
EPA's
determination
VerDate
Jan<
31>
2003
15:
16
Apr
08,
2003
Jkt
200001
PO
00000
Frm
00047
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
09APN1.
SGM
09APN1
17382
Federal
Register
/
Vol.
68,
No.
68
/
Wednesday,
April
9,
2003
/
Notices
that
numerical
standards
or
management
practices
are
not
warranted
for
dioxins
in
sewage
sludge
that
are
disposed
of
at
a
surface
disposal
unit
or
incinerated
in
a
sewage
sludge
incinerator.
66
FR
66228
(
December
21,
2001).
In
that
notice,
EPA
also
announced
that
a
final
action
on
the
proposal
to
amend
the
Standards
for
the
Use
or
Disposal
of
Sewage
Sludge
for
sewage
sludge
that
is
applied
to
the
land
would
be
published
at
a
later
date.
The
consent
decree
in
Gearhart
v.
Whitman
was
amended
to
extend
the
deadline
for
final
action
on
the
land
application
Round
Two
rulemaking
from
the
original
date
of
December
15,
2001,
to
a
new
date
of
October
17,
2003.
On
June
12,
2002
at
67
FR
40554,
EPA
published
a
Notice
of
Data
Availability
(
NODA)
containing
new
information
relating
to
dioxins
in
land­
applied
sewage
sludge
and
requested
public
comments.
Currently,
EPA
is
evaluating
the
public
comments
received
on
the
NODA
and
will
consider
these
comments
in
formulating
a
final
action
on
dioxins
in
land­
applied
Sewage
sludge
by
October
17,
2003.

II.
What
Requirements
Are
Included
in
the
Standards
for
the
Use
or
Disposal
of
Sewage
Sludge
(
40
CFR
Part
503)?
As
noted
above,
CWA
Section
405(
d)(
2)(
A)
required
the
first
round
of
regulation
to
be
based
on
``
available
information
on
[
the]
toxicity,
persistence,
concentration,
mobility,
or
potential
for
exposure''
of
toxic
pollutants
in
sewage
sludge.
EPA
published
the
Round
One
standards
(
40
CFR
Part
503)
on
February
19,
1993.
These
regulations
established
requirements
for
the
final
use
and
disposal
of
sewage
sludge
when
it
is:
(
1)
Applied
to
the
land
for
a
beneficial
purpose,
including
in
home
gardens,
(
2)
placed
in
a
surface
disposal
site,
including
biosolids­
only
landfills,
and
(
3)
incinerated.
For
land
application,
Part
503
set
numerical
limits
for
nine
heavy
metals
in
sewage
sludge,
established
operational
standards
(
described
below)
to
reduce
or
eliminate
pathogens
in
sewage
sludge
and
to
reduce
vector
attraction,
and
required
management
practices
to
restrict
the
application
rate
and
placement
of
sewage
sludge
on
the
land.
Regarding
surface
disposal,
Part
503
set
numerical
limits
for
three
metals
in
sewage
sludge,
established
requirements
for
the
placement
and
management
of
a
surface
disposal
site,
and
established
operational
standards
to
reduce
or
eliminate
pathogens
in
sewage
sludge
and
to
reduce
vector
attraction.
For
incineration
in
a
sewage
sludge
incinerator
(
SSI),
Part
503
establishes
limits
for
five
metallic
pollutants
in
sewage
sludge
fired
in
a
SSI
and
adopted
standards
under
the
Clean
Air
Act
for
two
additional
metallic
pollutants.
The
Agency
has
also
established
performance
standards
for
SSIs
through
an
operational
standard
for
total
hydrocarbons
or
carbon
monoxide
emissions
that
controls
numerous
organic
compounds
found
in
the
emissions
of
sewage
sludge
incinerators.
Part
503
also
allows
disposal
of
sewage
sludge
in
a
municipal
solid
waste
landfill
in
accordance
with
40
CFR
part
258.
In
addition,
the
final
rule
requires
monitoring,
record
keeping,
and
reporting.
Standards
apply
to
publicly
and
privately­
owned
treatment
works
that
generate
or
treat
domestic
sewage
sludge
and
to
anyone
who
uses
or
disposes
of
sewage
sludge.
The
part
503
Standards
consist
of
six
elements
designed
to
work
together
to
protect
human
health
and
the
environment.
These
elements
are
(
1)
numerical
limits
for
certain
pollutants,
(
2)
management
practices,
(
3)
operational
standards,
(
4)
monitoring,
(
5)
record
keeping,
and
(
6)
reporting.
As
an
example,
the
land
application
provisions
require
a
sewage
sludge
preparer
to
gather
information
on
the
nutrient
content
of
the
sewage
sludge
and
pass
this
information
along
to
the
land
applier
in
order
for
the
land
applier
to
be
able
to
apply
the
sewage
sludge
at
a
suitable
agronomic
rate.
Numerical
limitations
for
land­
applied
sludge
are
pollutant
concentrations
in
sewage
sludge
or
cumulative
or
annual
loading
rates,
based
on
multi­
pathway
exposure
analyses
and
risk
assessments
to
protect
public
health.
Management
practices
include
requirements,
such
as
how
the
sewage
sludge
is
to
be
placed
on
the
land
or
otherwise
managed
in
the
environment.
An
example
is
the
prohibition
against
applying
sewage
sludge
to
land
closer
than
10
meters
from
waters
of
the
United
States.
Operational
standards
are
technology
requirements
such
as
process
descriptions
and
performance
requirements
to
reduce
or
eliminate
pathogens
from
sewage
sludge
and
reduce
vector
attraction.
These,
together
with
required
crop
harvesting
restrictions
and
site
controls,
constitute
the
approach
for
the
control
of
pathogens
in
sewage
sludge.
Monitoring
of
chemicals
and
pathogens
in
sewage
sludge
and
certification
of
certain
actions
by
the
preparer
or
land
applier
must
be
performed
at
a
frequency
commensurate
with
the
annual
amount
of
land­
applied
sewage
sludge.
Records
must
be
kept
of
these
monitoring
and
certification
activities
at
the
locations
where
the
monitoring/
certifications
have
occurred.
Finally,
the
larger
sewage
sludge
preparers
and
land
appliers
must
report
this
information
to
the
permitting
authority
at
least
annually.
EPA
has
amended
part
503
several
times
since
its
initial
publication
in
February
1993.
Following
promulgation
of
the
Round
One
rule,
several
petitions
for
review
were
filed
challenging
various
aspects
of
the
rule.
In
one
petition,
several
mining
and
chemical
concerns
challenged
the
land
application
molybdenum
limits.
EPA
amended
the
part
503
numerical
standards
for
molybdenum
to
delete
the
cumulative
loading
rate,
annual
loading
rate,
and
the
pollutant
concentration
for
molybdenum
in
sewage
sludge
to
be
land­
applied.
59
FR
9095
(
February
25,
1994).
The
ceiling
concentration
value
for
molybdenum
was
retained.
Also,
in
that
Federal
Register
notice,
EPA
added
continuous
monitoring
of
carbon
monoxide
as
an
alternative
to
continuous
monitoring
of
total
hydrocarbons
in
the
sewage
sludge
incinerator
requirements.
In
another
case,
Leather
Industries
of
America
v.
EPA,
40
F.
3d
392
(
D.
C.
Cir.
1994),
the
court
remanded
several
of
the
land
application
requirements.
As
a
result
of
that
decision,
EPA
deleted
all
numerical
standards
for
chromium
in
sewage
sludge
to
be
land­
applied
and
adjusted
the
Table
3
limit
for
selenium.
60
FR
54764
(
October
25,
1995).
EPA
is
considering
further
amendments
to
address
the
issues
remaining
from
the
partial
remand,
as
well
as
other
issues.
EPA
most
recently
amended
Part
503
to
make
a
number
of
technical
amendments,
provide
regulatory
flexibility,
and
make
the
sewage
sludge
incinerator
standards
selfimplementing
64
FR
42552
(
August
4,
1999).
For
a
detailed
discussion
of
the
Part
503
Rule,
see
A
Plain
English
Guide
to
the
EPA
Part
503
Biosolids
Rule
(
1994),
which
is
available
as
stated
in
the
ADDRESSES
section
of
the
preamble.
A
copy
of
the
Plain
English
Guide
is
available
at
the
website
address
http://
www.
epa.
gov/
owm/
mtb/
biosolids/
503pe/
index.
htm.

III.
What
Is
the
Purpose
of
Today's
Notice?
Section
405(
d)(
2)(
C)
of
the
CWA
calls
on
EPA
to
review
the
existing
sewage
sludge
regulations
in
part
503
at
least
every
two
years
for
the
purpose
of
identifying
additional
toxic
pollutants
in
sewage
sludge
and
promulgating
regulations
for
such
pollutants
consistent
with
the
requirements
of
section
405(
d).
Over
the
past
decade,
questions
have
been
raised
over
the
VerDate
Jan<
31>
2003
15:
16
Apr
08,
2003
Jkt
200001
PO
00000
Frm
00048
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
09APN1.
SGM
09APN1
17383
Federal
Register
/
Vol.
68,
No.
68
/
Wednesday,
April
9,
2003
/
Notices
adequacy
of
the
chemical
and
pathogen
standards
for
protecting
human
health.
To
help
address
the
human
health
concerns
and
the
requirement
for
periodical
reassessment
of
the
Standards
for
Use
or
Disposal
of
Sewage
Sludge,
the
Agency
commissioned
the
NRC
to
independently
review
the
technical
basis
of
the
chemical
and
pathogen
regulations.
The
NRC
study
took
place
between
January
2001
and
June
2002.
In
July
2002,
the
NRC
published
a
report
entitled,
``
Biosolids
Applied
to
Land:
Advancing
Standards
and
Practices''
in
response
to
EPA's
request.
For
a
copy
of
the
full
NRC
report,
visit
our
Web
site
at
http://
www.
epa.
gov/
ost/
biosolids/
nas/
complete.
pdf.
The
NRC
identified
a
need
to
update
the
scientific
basis
of
Part
503
and
provided
approximately
60
recommendations.
In
an
agreement
with
the
parties
in
Gearhart
v.
Whitman,
EPA
agreed
to
publish
a
notice
in
the
Federal
Register
stating
how
it
will
respond
to
the
NRC
report
recommendations
and
to
seek
public
comments
on
its
planned
response.
EPA
also
agreed
to
review
publicly
available
information
for
the
purpose
of
identifying
additional
toxic
pollutants
in
biosolids
and
to
publish
a
notice
providing
the
results
of
the
review
and
seek
public
comment.
Today's
notice
fulfills
this
agreement.

IV.
What
Was
EPA's
Charge
to
the
National
Research
Council?
EPA
asked
the
NRC
to
conduct
an
independent
evaluation
of
the
regulations
and
standards
for
chemical
pollutants
and
pathogens
in
biosolids
that
are
land­
applied.
Specifically,
the
NRC
was
asked
to
focus
on
the
adequacy
and
appropriateness
of
the
risk
assessment
methods
and
data
used
by
the
Agency
in
setting
regulatory
requirements
to
protect
human
health.
The
NRC
convened
the
Committee
on
Toxicants
and
Pathogens
in
Biosolids
Applied
to
Land
(``
the
committee''),
which
conducted
and
prepared
a
final
report.
The
Statement
of
Tasks
included
the
following:
1.
Review
the
risk
assessment
methods
and
data
used
to
establish
concentration
limits
for
chemical
pollutants
in
biosolids
to
determine
whether
they
are
the
most
appropriate
approaches.
Consider
the
NRC's
previous
(
1996)
review
and
determine
whether
that
report's
recommendations
have
been
appropriately
addressed.
Consider
(
a)
how
the
relevant
chemical
pollutants
were
identified,
(
b)
whether
all
relevant
exposure
pathways
were
identified,
(
c)
whether
exposure
analyses,
particularly
from
indirect
exposures,
are
realistic,
(
d)
whether
the
default
assumptions
used
in
the
risk
assessments
are
appropriate,
and
(
e)
whether
the
calculations
used
to
set
pollutant
limits
are
appropriate.
2.
Review
the
current
standards
for
pathogen
reduction
or
elimination
in
biosolids
and
their
adequacy
for
protecting
public
health.
Consider
(
a)
whether
all
appropriate
pathogens
were
considered
in
establishing
the
standards,
(
b)
whether
enough
information
on
infectious
dose
and
environmental
persistence
exists
to
support
current
control
approaches
for
pathogens,
(
c)
risks
from
exposure
to
pathogens
found
in
biosolids,
and
(
d)
new
approaches
for
assessing
risks
to
human
health
from
pathogens
in
biosolids.
3.
Explore
whether
approaches
for
conducting
pathogen
risk
assessment
can
be
integrated
with
those
for
chemical
risk
assessment.
If
appropriate,
recommend
approaches
for
integrating
pathogen
and
chemical
risk
assessments.
The
NRC
report,
``
Biosolids
Applied
to
Land:
Advancing
Standards
and
Practices,''
described
the
work
of
the
committee,
stating
that
``
the
committee
searched
for
evidence
on
human
health
effects
related
to
biosolids
exposure''
in
its
review
of
the
risk
assessments
and
technical
data
used
by
EPA
to
establish
the
chemical
and
pathogen
standards
and
the
management
practices
contained
in
part
503.
The
report
noted
that
``
the
committee
did
not
attempt
to
determine
whether
the
approaches
used
by
EPA
to
set
the
1993
biosolids
standards
were
appropriate
at
the
time
of
their
development,
and
the
committee's
findings
and
recommendations
should
not
be
construed
as
either
criticism
or
approval
of
the
standards
issued
at
that
time.''

V.
What
Were
the
National
Research
Council's
Major
Findings
and
Recommendations
Concerning
Land
Application
of
Biosolids?
The
NRC
committee
concluded
that
``
there
is
no
documented
scientific
evidence
to
indicate
that
the
part
503
rule
has
failed
to
protect
human
health,''
but
additional
scientific
work
is
needed
to
reduce
persistent
uncertainty
about
the
potential
for
adverse
human
health
effects
from
exposure
to
biosolids.
The
committee
recognized
that
land
application
of
biosolids
is
a
widely
used,
practical
option
for
managing
the
large
volume
of
biosolids
generated
at
waste
water
treatment
plants
that
otherwise
would
need
to
be
disposed
of
at
landfills
or
by
incineration.
The
committee
also
identified
a
need
to
update
the
scientific
basis
of
part
503
to
(
1)
ensure
that
the
chemical
and
pathogen
standards
are
supported
by
current
scientific
data
and
risk
assessment
methods,
(
2)
demonstrate
effective
enforcement
of
part
503,
and
(
3)
validate
the
effectiveness
of
biosolids
management
practices.
The
NRC
report
focused
on
identifying
how
current
risk
assessment
practices
and
knowledge
regarding
chemical
pollutants
and
pathogens
in
biosolids
can
be
used
to
update
and
strengthen
the
scientific
basis
and
credibility
of
EPA's
biosolids
regulations.
The
NRC
report
contains
four
overarching
recommendations:
(
1)
Use
improved
risk
assessment
methods
to
better
establish
standards
for
chemicals
and
pathogens,
(
2)
conduct
a
new
national
survey
of
chemicals
and
pathogens
in
biosolids,
(
3)
establish
an
approach
to
human
health
investigations,
and
(
4)
increase
the
resources
devoted
to
EPA's
biosolids
program.
These
four
overarching
recommendations
are
discussed
in
detail
and
supplemented
by
53
individual
recommendations
contained
in
Chapters
2
 
6
of
the
NRC
report.

VI.
What
Process
Did
EPA
Use
To
Address
the
NRC
Recommendations?
Upon
the
release
of
the
report,
EPA
established
an
Intra­
Agency
Committee
(
IAC)
to
respond
to
the
recommendations
in
the
NRC
report
and
begin
review
of
the
existing
Part
503
regulations
to
identify
additional
toxic
pollutants
that
may
warrant
future
regulation,
pursuant
to
section
405(
d)(
2)(
C).
The
IAC
is
comprised
of
EPA
representatives
from
a
cross­
section
of
environmental
program
offices
that
are
involved
or
interested
in
the
biosolids
program.
The
IAC
first
developed
an
approach
for
responding
to
the
NRC
report
and
conducting
the
section
405(
d)(
2)(
C)
review
of
existing
regulations.
Activities
for
responding
to
the
NRC
report
included
developing
a
matrix
to
identify
and
track
each
recommendation,
grouping
the
recommendations
into
eight
categories
based
on
subject
area,
evaluating
the
recommendations
individually
and
establishing
priorities,
drafting
initial
responses
by
category,
and
developing
a
strategy
to
carry
out
the
activities
identified
in
response
to
the
NRC
recommendations.
The
approach
for
reviewing
existing
regulations
to
identify
additional
toxic
pollutants
that
may
warrant
regulation,
pursuant
to
section
405(
d)(
2)(
C),
is
described
in
Section
IX
of
this
notice.
As
stated
above,
the
IAC
first
prepared
a
matrix
(
Compilation
of
National
Research
Council
(
NRC)
Recommendations
on
Biosolids
and
VerDate
Jan<
31>
2003
15:
16
Apr
08,
2003
Jkt
200001
PO
00000
Frm
00049
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
09APN1.
SGM
09APN1
17384
Federal
Register
/
Vol.
68,
No.
68
/
Wednesday,
April
9,
2003
/
Notices
EPA
Responses
and
Activities,
USEPA
2002a)
of
all
of
the
recommendations
contained
in
the
NRC
report
(
NRC
2002).
The
matrix
ensured
that
all
recommendations
were
identified.
Once
in
the
matrix,
recommendations
that
were
found
to
be
similar
in
subject
matter
and
intent
were
placed
in
a
framework
to
facilitate
evaluation.
The
Agency
categorized
the
57
recommendations
(
four
overarching
and
53
specific)
into
eight
categories:
(
1)
Survey,
(
2)
Exposure,
(
3)
Risk
Assessments,
(
4)
Methods
Development,
(
5)
Pathogens,
(
6)
Human
Health
Studies,
(
7)
Regulatory
Activities,
and
(
8)
Biosolids
Management.
EPA's
response
and
planned
activities
are
presented
on
a
category­
by­
category
basis.

VII.
EPA's
Strategy
for
Responding
to
the
NRC
Recommendations?

EPA
has
identified
three
main
objectives
for
attaining
a
better
understanding
of
biosolids
and
reducing
the
potential
for,
or
reducing
the
uncertainty
related
to,
human
health
impact:
(
1)
Update
the
scientific
basis
of
Part
503
by
conducting
research
in
priority
areas,
(
2)
strengthen
the
biosolids
program
by
evaluating
results
of
completed,
ongoing,
or
planned
studies
both
within
and
outside
EPA,
and
(
3)
continue
ongoing
activities
for
enhancing
communication
with
outside
associations
and
with
the
public.

Major
Short­
Term
Goals
and
Priority
Actions
During
FY03
and
FY04
Over
the
next
two
years,
subject
to
available
resources,
the
Agency
proposes
to
pursue
biosolids
activities
in
the
following
priority
areas:
1.
Continue
program
implementation
(
regulatory,
compliance,
and
enforcement).
2.
Evaluate
the
state­
of­
the­
science
and
revise
risk
assessment
methodologies,
as
appropriate.
3.
Review
available
data,
track
ongoing
studies
by
researchers
outside
of
EPA,
and
identify
information
gaps.
Initiate
further
field
studies
as
needed.
4.
Continue
ongoing/
planned
activities
relative
to
exposure,
risk
assessment,
biosolids
management,
and
analytical
methods
development.
5.
Determine
what
pollutants,
if
any,
warrant
further
regulation
under
the
CWA.
6.
Design
and
begin
conducting
a
targeted
survey
that
uses
information
obtained
from
published
pollutant
occurrence
and
effects
data,
State
occurrence
data
bases,
and
input
received
during
the
public
comment
period.
7.
Conduct
a
dialogue
with
other
health­
based
Federal
agencies,
such
as
CDC,
on
the
possibility
of
cooperatively
tracking
incident
reports
and
investigating
whether
adverse
human
health
outcomes
can
be
associated
with
biosolids
exposure.
The
results
could
help
the
Agency
identify
research
gaps
and,
if
appropriate,
the
need
for
a
more
comprehensive
research
plan.
These
activities
would
be
aimed
at
implementing
NRC
recommendations
for
reducing
the
potential
for
public
health
impact
and
updating
the
scientific
basis
of
Part
503.

Major
Longer­
Term
Goals
and
Future
Priorities
(
FY05
and
Beyond)

The
Agency's
proposed
long­
term
biosolids
activities
depend
on
results
of
activities
conducted
in
FY03/
FY04
and
available
resources.
The
following
priority
areas
are
aimed
at
implementing
recommendations
for
reducing
the
potential
for
public
health
impact:
1.
Continue
program
implementation
(
regulatory,
compliance,
and
enforcement).
2.
Update
the
scientific
basis
of
Part
503
by
using
FY03/
04
research
or
by
conducting
research
in
priority
areas.
3.
Strengthen
the
biosolids
program
by
incorporating
results
of
completed,
ongoing,
or
planned
research
activities
both
within
and
outside
EPA
to
possibly
include:
 
Quantitative
microbial
risk
assessment.
 
Improved
understanding
of
exposure
pathways/
scenarios.
 
Molecular
tracking
study.
4.
Continue
activities
to
establish
partnerships
and
communicate
more
effectively
with
other
public
healthbased
agencies,
outside
associations
and
the
public.
There
is
considerable
relevant
work
being
conducted
by
others
outside
of
EPA
that
may
help
inform
and
respond
to
the
NRC
recommendations.
Much
of
the
external
work
that
relates
directly
to
certain
NRC
recommendations
is
discussed
in
this
notice
and
is
being
used
to
improve
the
Agency's
biosolids
program.
The
Agency's
approach
also
includes
promoting
policy
and
procedural
guidance
for
ensuring
and
maximizing
the
quality
of
the
information
disseminated.
Completed
studies
and
ongoing
research,
once
compiled,
will
be
reviewed
and
evaluated
for
their
contribution
to
EPA's
biosolids
program
in
accordance
with
Information
Quality
Guidelines
(
expressed
in
``
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
the
Environmental
Protection
Agency''
USEPA
2002b).
These
guidelines
stress
that
information
disseminated
by
EPA
should
adhere
to
a
basic
standard
of
quality,
including
objectivity,
utility,
and
integrity.
EPA
has
developed
this
notice
using
its
best
estimate
of
FY
2003
resources,
which
are
not
finalized,
and
based
on
the
President's
FY
2004
budget.
The
Agency
has
assumed
the
same
level
of
funding
for
future
years,
as
is
typically
done.

VIII.
EPA
Responses
to
the
NRC
Recommendations
by
Category
A.
Survey
1.
Summary
of
Survey­
Related
NRC
Report
Recommendations
The
NRC
recommended
that
the
Agency
conduct
a
new
national
survey
of
chemicals
and
pathogens
in
biosolids.
A
survey
may
provide
feedback
for
updating
the
science
and
technology
of
biosolids
applied
to
land.
These
data
would
then
be
used
to
identify
pathogens
and
additional
chemicals
for
potential
regulation
and
possibly
deregulate
those
that
are
not,
or
no
longer,
found.
The
NRC
recommended
several
components
in
designing
a
new
national
survey,
including
collecting
data
from
State
program
databases,
determining
the
adequacy
of
analytical
detection
methods
and
limits
to
support
risk
assessment,
evaluating
chemicals
eliminated
previously
due
to
lack
of
data
(
e.
g.,
toxicity
or
exposure)
and
new
chemical
categories
(
e.
g.,
odorants,
surfactants
and
pharmaceuticals)
not
previously
evaluated.
Further,
the
NRC
recommended
monitoring
environmental
media,
surveying
for
pathogens
in
both
raw
sewage
sludge
and
treated
sewage
sludge
managed
through
the
various
processes
recommended
in
Part
503,
assessing
multiple
species
of
certain
metals
(
e.
g.,
mercury
and
arsenic)
that
have
different
toxicity
profiles
for
human
health,
including
infants
and
children,
and
analyzing
a
broad
spectrum
of
pathogens
in
biosolids
or
environmental
media
adjacent
to
final
use
or
disposal
sites.
In
addition,
the
NRC
recommended
that
the
Agency
verify
the
adequacy
of
treatment
and
management
practices.
For
example,
to
verify
that
Class
A
and
B
(
as
described
in
Part
503)
treatment
processes
perform
as
assumed
by
engineering
and
design
principles,
EPA
could
determine
pathogen
density
and
elimination
across
treatment
processes
in
biosolids
and
environmental
media
over
time
and
examine
management
practices
to
ensure
that
risk­
assessment
VerDate
Jan<
31>
2003
15:
16
Apr
08,
2003
Jkt
200001
PO
00000
Frm
00050
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
09APN1.
SGM
09APN1
17385
Federal
Register
/
Vol.
68,
No.
68
/
Wednesday,
April
9,
2003
/
Notices
principles
are
effectively
translated
into
practice.

2.
The
Agency's
Response
to
the
Survey
Category
How
EPA
Plans
To
Address
NRC
Survey
Recommendations
The
Agency
believes
that
a
comprehensive
survey
of
pollutants
in
biosolids
may
provide
useful
information,
but
it
is
not
likely
the
most
pragmatic
survey
option
available
at
this
time.
EPA
has
developed
a
proposed
survey
approach
based
on
experience
gained
from
the
1988
National
Sewage
Sludge
Survey
(
NSSS),
limitations
of
available
analytic
methods,
knowledge
of
effects
and
routes
of
exposure,
and
suggestions
by
the
NRC,
among
other
factors
(
see
Planned
Strategy
for
the
Survey
Category
below).
The
1988
NSSS
was
ultimately
limited
in
utility
by
shortcomings
in
available
analytical
methods
and
limited
information
of
pollutant
effects
and/
or
means
of
exposure.
While
some
advances
in
these
areas
have
been
made
since
1988,
these
same
limitations
still
exist
for
many
pollutants,
especially
for
pathogens
and
many
of
the
new
or
emerging
chemicals
identified
by
the
NRC.
Therefore,
EPA
has
concluded
that
a
less
comprehensive,
more
targeted,
survey,
to
help
fill
data
gaps
and
inform
decisions
regarding
further
studies,
may
be
more
useful
to
address
uncertainties
highlighted
by
the
NRC.
Information
developed
by
national
and
international
experts
on
pathogens
and
toxic
chemicals
may
help
produce
a
better
informed
survey
design.
The
Agency
believes
that
using
such
information
may
produce
more
valuable
results
than
conducting
a
comprehensive
national
survey
at
this
time.
EPA
is
first
planning
to
develop
and
initiate
a
targeted
survey
after
considering
the
following
sources
of
information:
Available
data:
The
Agency
has
conducted
a
biosolids
literature
search
and
is
reviewing
the
information
for
relevant
data
on
chemicals
and
pathogens
in
biosolids.
The
literature
search
includes
topics
related
to
a
survey
of
chemicals
and
pathogens
in
biosolids,
management
practices,
and
treatment
efficacy.
This
information
obtained
may
also
assist
EPA
in
responding
to
other
NRC
recommendations.
For
example,
the
Agency
plans
to
use
available
information
to
prioritize
future
research
and,
if
necessary,
modify
biosolids
management
practices
to
reduce
risk.
Other
sources
of
data
include
studies
conducted
by
EPA
regional
offices,
States,
and
universities.
For
example,
EPA
Region
8
is
conducting
a
long­
term
study
of
biosolids
addition
to
soil
and
the
potential
effects
on
soil
microbiology.
The
University
of
Arizona
is
conducting
research
on
airborne
pathogen
exposure
at
various
times
and
distance
from
biosolids
application
sites.
Within
the
next
six
to
nine
months,
the
Agency
plans
to
review
and
assess
such
studies
for
their
contribution
in
determining
the
potential
for
exposure
and
adverse
human
health
impact
from
land­
applied
biosolids.
Studies:
Ongoing
EPA
studies
address
many
technical
uncertainties
related
to
pollutants
in
biosolids.
For
example,
the
adequacy
of
current
analytical
methods
for
selected
priority
pathogens
and
the
development
and/
or
validation
of
new
methods
are
also
being
studied.
In
addition,
field
studies
are
being
used
to
provide
site­
specific
occurrence
data.
While
study
emphasis
is
being
placed
on
pathogens
to
address
areas
of
uncertainty
and
public
interest,
selected
chemicals
are
also
being
addressed
to
help
determine
significant
issues
and
identify
information
gaps
that
remain
to
be
addressed
in
these
areas.

Planned
Strategy
for
Designing
a
Targeted
Survey
During
the
next
fiscal
year
the
Agency
plans
to
initiate
or
continue
Studies
devoted
to:
1.
Methods
development
and/
or
validation
studies
for
enteric
viruses
and
helminth
ova
(
see
Methods
Development).
2.
Continuation
and/
or
expansion
of
field
studies
to
determine
environmental
contaminant
occurrence
at
selected
sites
(
see
Methods
Development
and
Pathogens
Categories).
In
addition,
during
the
next
18
to
24
months,
EPA
is
proposing
to
design
a
targeted
approach
for
a
survey
of
pollutants
that
occur
in
sewage
sludge.
New
and
existing
information
from
sources
such
as
relevant
published
pollutant
occurrence
and
effects
data,
State
occurrence
databases,
and
input
received
during
the
public
comment
period
will
be
used
to
help
in
the
development
of
the
proposed
survey.
To
ensure
the
survey
provides
meaningful
results
and
the
effective
use
of
limited
resources,
EPA
is
considering
restudying
some
of
the
pollutants
that
were
studied
in
the
1988
 
1989
NSSS.
EPA
is
also
considering
including
some
new
and
emerging
chemicals,
taking
into
account
the
availability
of
adequate
analytical
methods
and
their
associated
analytical
costs.
As
a
result,
the
Agency
may
only
be
able
to
measure
a
limited
number
of
pollutants.
B.
Exposure
1.
Summary
of
Exposure
NRC
Recommendations
The
NRC
made
recommendations
on
how
current
exposure
information
and
updated
conceptual
exposure
models
can
be
used
to
update
and
strengthen
the
scientific
basis
of
the
chemical
and
technology­
based
pathogen
standards.
This
category
also
includes
recommendations
to
evaluate
exposure
for
the
reasonable
maximum
exposure
(
RME)
individual,
updating
fate
and
transport
models
that
might
affect
exposure
estimates,
and
conducting
preplanned
exposure
studies
under
certain
situations
for
specific
exposure
groups.

2.
The
Agency's
Response
to
the
Exposure
Category
How
EPA
Plans
To
Address
NRC
Exposure
Recommendations
Understanding
human
exposure
to
chemicals
and
pathogens,
including
the
concentrations
and
fate
and
transport
through
important
exposure
pathways,
is
key
for
risk
assessments
supporting
the
Part
503
rule.
As
discussed
below
in
the
Risk
Assessment
category,
the
Agency
plans
to
use
a
risk
assessment
framework
to
evaluate
the
priorities
for
reassessing
or
updating
underlying
components
(
including
exposure
assumptions)
of
previously
conducted
risk
assessments.
The
Agency
plans
to
use
this
information
to
determine
if
new
exposure
and
risk
calculations
may
be
warranted
for
pollutants
not
previously
assessed.
Such
an
evaluation
would
include
a
review
of
the
exposure
information
used
in
the
Round
1
and
Round
2
rules
in
light
of
new
exposure
information.
To
conduct
this
activity,
the
Agency
plans
to
first
collect
and
review
currently
available
exposure
information
from
published
literature,
Federal
and
State
databases,
the
NRC
report,
and
other
relevant
sources.
The
Agency
anticipates
that
some
of
the
NRC
recommendations
regarding
exposure
may
be
addressed
in
newly
available
information,
while
others
may
require
completion
of
ongoing
studies.
The
Agency
plans
to
review
currently
available
exposure
information
to
help
identify
data
gaps
and
to
inform
decisions
about
future
risk
assessments
and
the
need
for
additional
exposure
studies.
In
the
mid­
1990'
s,
EPA
conducted
research
on
the
land
application
of
biosolids
to
disturbed
and
contaminated
sites
requiring
reclamation
or
remediation.
These
studies,
which
focused
on
the
ability
of
biosolids
to
help
improve
soil
properties
and
VerDate
Jan<
31>
2003
15:
16
Apr
08,
2003
Jkt
200001
PO
00000
Frm
00051
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
09APN1.
SGM
09APN1
17386
Federal
Register
/
Vol.
68,
No.
68
/
Wednesday,
April
9,
2003
/
Notices
establish
sustainable
vegetation
cover
on
disturbed
and
highly
contaminated
sites,
also
included
identification
and
determination
of
metals
bioavailability
in
biosolids.
The
research
was
conducted
to
strengthen
our
understanding
of
the
potential
health
impacts
of
metals,
a
particular
focus
during
the
development
of
the
1993
regulations.
Results
of
this
work
showed
that
assumptions
regarding
metals
availability
used
in
earlier
metals
risk
assessments
were
conservative.
The
Agency
plans
to
reevaluate
these
findings
in
context
with
current
practices
and
policies
regarding
exposure
to
metals
in
biosolids.
Exposure
research:
As
part
of
a
broader
set
of
field
studies,
EPA
recently
initiated,
in
partnership
with
USDA
and
the
State
of
Pennsylvania
(
PA),
the
planning
of
exposure­
related
research
at
five
biosolids
production
and/
or
application
sites.
These
studies
are
intended
to
gather
site­
specific
information
on
current
practices
in
biosolids
production
and
application,
and
to
identify
and
evaluate
the
fate
of
pollutants
following
biosolids
application.
Other
objectives
for
this
research,
depending
on
the
site,
include
(
1)
characterization
of
treated
and
untreated
sludge
(
biological,
physical,
and
chemical
characterization),
along
with
sampling
and
analysis
during
land
application,
(
2)
assessing
the
presence
of
pathogens,
nitrogen,
sulfur,
volatile
organic
compounds
and
particulates
in
air,
(
3)
determining
how
well
the
sewage
sludge
is
disinfected
as
it
moves
through
the
different
stages
of
processing,
and
(
4)
determining
pathogen
content
in
Class
B
sludge,
once
applied
and
following
a
period
of
natural
attenuation.
Other
related
work
is
being
conducted
by
the
University
of
Arizona's
Water
Quality
Center.
Planned
work
is
expected
to
begin
in
mid
2003.
The
plan
is
for
facility
operations
for
these
sites
to
be
documented,
including
the
operation
and
performance
of
treatment
process
used
to
process
sewage
sludge
and
produce
Class
A
and
Class
B
biosolids.
Pathogen
and
chemical
occurrence
data
will
also
be
collected
at
these
sites.
Proposed
measurements
over
time
for
the
production
and
land
application
processes
may
include
total
and
volatile
solids,
pH,
temperature,
odor,
appearance
(
e.
g.,
color,
paste,
liquid,
powder),
fecal
coliforms,
Salmonella
spp.,
Staphylococcus
aureus,
enteric
viruses,
and
helminth
ova.
Because
of
concern
over
bioaerosols,
air
samples
will
be
taken
prior
to,
during,
and
following
land
application
at
the
point
of
application
and
the
fence
line,
for
up
to
thirty
days.
Air
sampling
will
be
conducted
in
collaboration
with
USDA
to
address
pathogens,
chemicals,
endotoxins,
and
particulates
occurrence.
Chemical
and
pathogen
concentrations
in
air
represent
an
initial
step
towards
understanding
the
potential
exposure
of
nearby
communities.
A
description
of
the
proposed
studies
can
be
found
in
the
Pathogens
category.
CAFO
research:
EPA
is
also
conducting
research
on
microorganisms
and
chemicals
at
animal
manure
land
application
sites,
composting
sites,
and
concentrated
animal
feeding
operations
(
CAFOs).
These
include
studies
on
the
concentrations
of
airborne
pathogens,
toxic
organic
compounds,
odorants,
and
particulates.
The
CAFO
studies
are
important,
because
pathogen
and
chemical
air
transport
and
fate
for
animal
manures
resemble
those
for
biosolids.
The
ongoing
and
proposed
studies
are
described
in
the
Methods
Development
category
in
this
notice.

Planned
Exposure
Activities
EPA
plans
to
continue
its
research
partnership
with
USDA
and
the
State
of
PA
and
to
study
an
additional
five
field
application
sites.
The
Agency
is
exploring
a
plan
to
conduct
a
molecular
pathogen
tracking
exposure
study
as
a
follow­
up
to
the
PA/
USDA/
EPA
study.
This
study
would
focus
on
individuals
who
have
received
medical
attention
and
who
suspect
that
they
have
been
affected
by
biosolids
application
practices.
This
study
would
analyze
human
biological
monitoring
samples
(
e.
g.,
feces,
blood,
or
swabs
from
skin,
ears,
eyes,
or
throat)
to
isolate
potential
causative
agents,
and
genetic
characterization
would
be
used
to
identify
the
potential
source(
s).

C.
Risk
Assessment
1.
Summary
of
Risk
Assessment
NRC
Recommendations
The
NRC
recommended
that
the
Agency
use
improved
risk
assessment
methods
to
better
assess
risks
and
establish
standards
for
chemicals
and
pathogens
under
Part
503,
since
methods
for
conducting
risk
assessments
have
evolved
substantially
since
the
1993
regulations
were
established.
The
recommendations
also
include
reassessing
standards
for
chemicals
currently
in
the
Part
503
regulation
using
the
latest
science.
The
NRC
suggested
that
future
risk
assessments
incorporate
new
information
on
exposure,
dose­
response
relationships,
pathogen
survival,
quantitative
microbial
risk
assessment
techniques,
and
consideration
of
sitespecific
factors
that
may
affect
risk
management
practices
(
e.
g.,
odor).
Recommendations
were
also
made
to
involve
stakeholders
in
the
risk
assessment
process
and
to
examine
biosolids
management
practices
to
ensure
that
the
underlying
risk
assessment
principles
are
effectively
translated
into
practice.

2.
The
Agency's
Response
for
the
Risk
Assessment
Category
How
EPA
Plans
To
Address
NRC
Risk
Assessment
Recommendations
Current
and
Planned
Risk
Assessment
Activities
For
this
notice,
risk
assessment
is
defined
as
the
process
of
identifying
the
potential
adverse
health
effects
associated
with
environmental
exposures
to
pollutants
in
biosolids,
their
severity,
and
likelihood.
Previously,
EPA
used
a
risk
based
approach
for
estimating
risks
to
human
health
and
developing
management
practices
to
reduce
risks
and
set
protective
standards.
When
they
were
conducted,
EPA's
assessments
were
based
on
state­
of­
the­
science
methods,
information
and
management
practices.
The
NRC
recommended
areas
where
new
or
updated
health
and
exposure
information,
models,
and
risk
assessment
methods
may
strengthen
the
Agency's
assessments
for
land­
applied
biosolids.
Consistent
with
the
recommendations
of
the
NRC,
EPA
plans
to
address
the
potential
health
hazards
and
exposures
associated
with
land
application
of
biosolids
using
state­
of­
the­
science
risk
approaches.
Specifically,
EPA
plans
to
reassess
methods
and
data
used
for
previously
evaluated
pollutants,
and
apply
these
methods
to
new
pollutants.
For
example,
risks
from
pollutants
not
previously
assessed
due
to
a
lack
of
toxicity,
environmental
fate,
or
exposure
information,
will
be
reevaluated
if
new
information
is
available.
This
effort
is
expected
to
take
place
in
FY03
and
FY04.
The
Agency
has
assessed
risks
to
children
and
sensitive
populations,
and
will
continue
that
approach
in
future
assessments
and
reassessments.
The
NRC
also
recommended
that
representative
stakeholders
could
be
included
in
the
risk
assessment
process
to
help
identify
exposure
pathways,
local
conditions
that
could
influence
exposure,
and
possible
adverse
health
outcomes.
The
Agency's
policy
is
to
involve
stakeholders
at
various
stages
of
policy
development.
The
Agency
intends
to
consider
how
consultation
with
stakeholders
should
be
included
in
developing
future
sewage
sludge
risk
assessments.
EPA,
in
conjunction
with
States
and
other
Federal
agencies,
has
already
been
addressing
local
biosolids
issues
in
a
VerDate
Jan<
31>
2003
15:
16
Apr
08,
2003
Jkt
200001
PO
00000
Frm
00052
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
09APN1.
SGM
09APN1
17387
Federal
Register
/
Vol.
68,
No.
68
/
Wednesday,
April
9,
2003
/
Notices
few
areas,
and
has
used
these
opportunities
to
include
stakeholders
in
the
process
to
further
evaluate
and
improve
the
assessment
and
management
of
biosolids.
For
example,
stakeholders
were
involved
in
the
scenario
development
and
regulatory
processes
of
a
recent
study
in
Pennsylvania.
As
part
of
this
study,
an
informal
information
sharing
group
was
formed
that
included
concerned
citizens,
local
officials,
and
contractors
to
assist
the
Agency
in
identifying
stakeholder
concerns
and
ensuring
transparency
in
the
field
study
process.
For
the
ongoing
Round
Two
land
application
rulemaking,
EPA
conducted
a
revised
risk
assessment
in
response
to
public
and
peer
review
comments
on
the
1999
Round
Two
proposal.
This
revised
assessment
used
a
probabilistic
approach
instead
of
a
deterministic
approach
to
yield
information
on
the
sources
of
variability
and
uncertainty
in
the
final
risk
estimates.
The
probabilistic
approach
used
estimated
values
for
certain
input
variables
over
the
range
of
observed
data
to
estimate
the
risks
for
the
highly
exposed
population.
This
revised
risk
assessment
also
used
new
inputs,
which
included
a
redefined
``
highly
exposed
individual,''
new
pathways
and
mechanisms
of
exposure,
new
exposure
factors
adopted
from
the
latest
EPA
Exposure
Factors
Handbook,
a
sensitivity
analysis
to
determine
the
relative
importance
of
the
input
variables,
and
updated
scientific
information
on
the
chemicals
of
concern,
dioxins.
EPA
redefined
the
``
highly
exposed
individual''
as
a
member
of
a
farm
family
that
consumes
50
percent
of
his/
her
diet
from
homeproduced
crops
and
animal
products
grown
on
his/
her
own
biosolidsamended
land.
EPA
plans
to
use
the
Round
Two
risk
assessment
approach
as
a
starting
point
for
evaluating
the
NRC's
recommendations,
including
the
use
of
the
reasonable
maximum
exposed
(
RME)
individual
for
improving
future
risk
assessments.
EPA
is
currently
funding
and
conducting
research
related
to
risk
assessment
of
biosolids.
EPA
is
sponsoring
research
or
has
awarded
grants
to
the
Water
Environment
Research
Foundation
(
WERF)
and
others
to
develop
quantitative
pathogen
risk
assessment
methods
and
approaches.
EPA
plans
to
conduct
a
comprehensive
evaluation
and
peer
review
of
these
results
and,
if
deemed
appropriate
for
use
in
assessing
risk
from
pathogens
found
in
biosolids,
the
Agency
would
incorporate
these
new
risk
assessment
methods
into
any
new
or
updated
risk
assessment
and
update
the
part
503
rule
as
necessary.
Other
studies
and
related
activities
that
EPA
is
conducting
or
sponsoring
include
the
development
of
doseresponse
models
for
quantitative
risk
assessment
of
selected
pathogens
and
the
development
of
transmission
models
of
pathogens
and
disease.
These
models
are
currently
being
developed
for
drinking
water
and,
EPA
plans
to
evaluate
and,
if
appropriate,
modify
applicable
models
to
be
used
in
analyzing
pathogens
in
biosolids.
In
addition,
research
is
being
conducted
with
USDA
and
various
States
on
the
extent
of
airborne
concentrations
of
pathogens,
toxic
compounds,
odorants,
particulates
and
bioaerosols.
EPA
plans
to
evaluate
the
results
of
these
studies
for
use
in
refining
and
improving
future
biosolids
exposure
and
risk
assessments.
Further
descriptions
of
these
studies
are
provided
in
the
pathogen
section
and
the
action
plan.
To
further
the
state
of
the
knowledge
surrounding
all
aspects
of
sewage
sludge
use
and
disposal,
including
improved
risk
assessments,
EPA
is
supporting
a
workshop
scheduled
for
January
of
2004
on
the
``
state
of
the
science''
on
land
application
of
municipal
and
industrial
wastewater
effluents,
sewage
sludge,
and
animal
manures.
This
workshop
is
being
coordinated
by
the
University
of
Florida
and
will
have
numerous
contributors
from
the
Agricultural
Research
Service
of
USDA,
and
academia,
among
other
groups.
New
and
additional
information
on
biosolids
toxicities
and
environmental
properties
may
emerge
from
this
workshop;
once
evaluated,
this
information
may
be
used
in
future
risk
assessment
updates
of
the
Part
503
Rule.
The
Web
site
http://
www.
conference.
ifas.
ufl.
edu/
landapp/
contains
information
concerning
the
upcoming
workshop,
as
well
as
other
relevant
information.
As
discussed
previously,
EPA
may
use
the
risk
assessment
paradigm
to
provide
both
a
focused
reassessment
of
certain
previously
addressed
pollutant
risks,
exposure
pathways
and
risk
assessment
approaches,
as
well
as
assessing
pollutants
which
have
not
been
previously
evaluated
to
effectively
address
the
NRC
risk
assessment
related
recommendations
and
the
review
required
by
Section
405(
d)(
2)(
C)
of
the
CWA.
These
risk
assessment
activities
will
be
initiated
this
year.
This
effort
will
be
developed
and
outlined
by
an
interdisciplinary
workgroup
within
EPA
and
include
external
review
of
the
analysis
plan.
For
this
risk
analysis,
EPA
is
planning
to
focus
on
an
evaluation
of
those
key
pollutants
and
pathways
which
are
likely
to
be
of
greatest
concern
or
where
the
new
scientific
developments
may
have
the
greatest
impacts.
This
may
result
in
later
updating
the
Round
One
risk
assessment
models
and
reevaluating
selected
pollutants,
pathways
and
endpoints
and/
or
new
pathways
and
endpoints
not
previously
addressed.
EPA
is
planning
a
two­
step
process
for
addressing
the
NRC
recommendations
with
respect
to
risk
assessments
for
pollutants
in
sewage
sludge.
The
first
step
would
be
to
conduct
a
problem
formulation
which
would
re­
evaluate
or
assess
methods,
approaches
and
pollutants
considered
in
the
Round
One
determinations,
and
any
new
qualitative
information
for
future
pollutants.
This
problem
formulation
step
would
include
the
development
of
exposure/
risk
assessment
scenarios
that
would
be
used
to
identify
critical/
key
stressors,
routes
of
exposure,
model
application
and
data
gaps.
The
primary
focus
of
this
effort
will
be
on
areas
having
the
greatest
potential
risks
and
uncertainties
(
e.
g.
pathogens).
The
problem
formulation
will
serve
to
eliminate
those
stressors,
scenarios,
routes
of
exposure,
and
endpoints
that
need
not
be
evaluated
further.
It
would
retain
those
areas
which
are
potentially
significant
or
require
more
study.
The
problem
formulation
would
also
result
in
a
research
analysis
plan
that
would
not
only
identify
risk
assessment
activities
but
also
prioritize
research
to
address
exposure
and
risk
management.
The
second
step
would
be
to
conduct
quantitative
risk
assessments
and
risk
characterizations
for
key
pollutants
identified
and
prioritized
by
the
scenario/
conceptual
models,
as
appropriate.
These
assessments
would
initially
be
screening
level
risk
assessments.
More
refined
assessments
would
be
conducted
only
on
those
pollutants
and
pathways
for
which
the
screening­
level
assessment
indicate
significant
potential
for
risk.
In
conducting
any
risk
assessments,
screening
or
comprehensive,
EPA
will,
as
appropriate,
apply
the
most
up­
todate
scientific
information
and
risk
assessment
methodologies.
In
addition,
EPA
proposes
to
continue
its
efforts
to
evaluate
and
develop
new
methods
for
pathogen
risk
assessments
and
improved
models
for
exposure
assessments.
EPA's
proposed
activities
are
to
continue
to
track
development
of
methods
for
QMRAs
and
develop
guidelines
for
assessing
risk
from
pathogens.
In
addition,
EPA
also
plans
to
continue
work
on
the
evaluation
of
data
and
models
for
improving
exposure
assessments.
EPA
may
also
evaluate
and
VerDate
Jan<
31>
2003
15:
16
Apr
08,
2003
Jkt
200001
PO
00000
Frm
00053
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
09APN1.
SGM
09APN1
17388
Federal
Register
/
Vol.
68,
No.
68
/
Wednesday,
April
9,
2003
/
Notices
assess
data
and
information
related
to
multiple
exposures,
potential
contaminant
interactions,
and
potential
effects
on
sensitive
sub­
populations,
to
the
extent
the
state­
of­
the­
science
is
available.

D.
Methods
Development
1.
Summary
of
Methods
Development
NRC
Recommendations
The
NRC
recommended
that
the
Agency
develop
and
standardize
methods
for
measuring
pathogens
and
emerging
chemicals
in
biosolids
and
bioaerosols.
Standardized
methods
could
be
used
to
provide
measures
of
performance
and
to
verify
that
the
Agency's
management
practices
and
standards
are
reliable.
Specifically,
the
NRC
recommended
developing,
standardizing,
and
validating
methods
for
pathogens
in
biosolids
and
bioaerosols
(
e.
g.,
airborne
pathogens).
In
addition,
research
that
uses
improved
pathogen
detection
technology,
round­
robin
laboratory
testing
to
establish
method
accuracies
and
precision
for
pathogen
concentrations
in
raw
and
treated
biosolids,
mechanisms
for
incorporating
new
methodologies
into
the
verification
process,
and
measures
of
performance
that
can
be
monitored
(
e.
g.,
concentrations
of
selected
chemicals
in
exposure
media
and
human
biological
monitoring
such
as
blood
or
urine
of
workers
and
residents)
could
be
considered
useful
in
conducting
and
interpreting
future
risk
assessments
and
used
to
develop
applicable
riskassessment
technologies.

2.
The
Agency's
Response
to
Methods
Development
How
EPA
Plans
To
Address
NRC
Methods
Development
Recommendations
For
the
methods
development
category,
the
Agency
plans
to
focus
its
resources
on
pathogens
and
chemicals
associated
with
biosolids.
Validated
analytical
methods
are
necessary
to
support
exposure
assessments
for
toxic
pollutants
and
pathogens.
Methods
are
needed
for
determining
the
reliability
of
treatment
processes,
assaying
pathogens
and
chemicals
in
raw
and
treated
biosolids,
incident
follow­
up,
sampling
environmental
media,
and
human
biological
monitoring.
Ongoing
or
planned
methods
development
activities
in
the
Agency
that
address
the
NRC
recommendations
follow.

Method
Development
Activities
Recently
initiated
EPA
methods
development
work
includes
field
studies
at
five
biosolids
production
and
application
sites.
Currently
available
analytical
methods
are
being
identified
or
in
some
cases
adapted
for
this
study.
A
description
of
these
field
studies
has
been
provided
in
the
preceding
Exposure
subsection
of
this
notice.
Additionally,
EPA
is
conducting
field
studies
at
animal
manure
land
application
sites,
composting
sites,
and
concentrated
animal
feeding
operations
(
CAFOs).
This
research
includes
measurements
of
pathogens,
toxic
organic
compounds,
odorants
and
particulates
in
the
air
near
CAFOs.
Both
the
biosolids
and
CAFO
studies
include
evaluation
and
adaptation
of
analytical
methods
for
selected
pathogens
and
chemicals.
Results
of
these
studies
should
assist
the
Agency
in
determining
the
need
for
additional
methods
development
research.
Open­
path
Fourier
Transform
Infrared
(
FTIR)
spectrometry
will
be
used
to
measure
volatile
organic
compounds
from
land
application
sites.
EPA
is
validating
analytical
methods
for
microorganisms
cited
in
40
CFR
Part
503.
Fecal
coliform
methods
have
been
validated,
whereas
Salmonella
methods
are
being
validated.
Methods
and
validation
studies
for
these
two
agents
are
expected
to
be
published
in
2004.

Planned
Method
Development
Activities
As
part
of
its
field
study
programs,
EPA
plans
to
work
with
USDA
to
investigate
methods
for
measuring
bacteria
and
viruses
in
air
upwind
and
downwind
of
biosolids
land
application
sites.
EPA
is
considering
developing
and
validating
analytical
methods
for
enteric
viruses
and
helminth
ova,
as
well
as
chemical
analytical
methods
for
emerging
chemicals
of
potential
concern
in
biosolids
(
e.
g.
pharmaceuticals).

E.
Pathogens
1.
Summary
of
Pathogen
NRC
Recommendations
The
NRC
recommended
that
the
Agency
review
approaches
for
developing
microbial
analytical
methods
and
conducting
microbial
risk
assessments
(
Quantitative
Microbial
Risk
Assessments)
to
analyze
sensitivity
and
to
ascertain
what
critical
information
is
needed
to
reduce
uncertainty
about
the
risks
from
exposure
to
pathogens
in
biosolids.
According
to
the
NRC,
research
activities
that
might
improve
EPA's
pathogen
standards
and
reduce
risk,
or
uncertainties
concerning
risk,
from
pathogens
following
exposure
to
biosolids
include
development,
standardization
and
validation
of
detection
and
quantification
methods
for
pathogens
and
indicator
organisms,
conducting
research
on
vectors
carrying
pathogens
and
bioaerosols,
and
conducting
studies
to
determine
whether
site
restrictions
for
Class
B
achieve
intended
effects
for
pathogen
levels.
The
NRC
also
recommended
that
EPA
not
allow
provisions
for
distributing
Class
A
biosolids
in
bags
or
other
containers
(
weighing
less
than
one
metric
ton)
when
they
do
not
meet
pollutant
concentration
limits
(
i.
e.,
all
biosolids
sold
or
given
away
should
be
exceptional
quality).
Other
NRC
recommendations
include
considering
additional
indicator
organisms
(
e.
g.,
Clostridium
perfringens)
for
use
in
regulations,
as
well
as
funding,
supporting
and
officially
sanctioning
the
Pathogen
Equivalency
Committee
(
PEC)
as
part
of
the
Federal
program.
National
field
and
laboratory
surveys
to
verify
that
Class
A
and
Class
B
treatment
processes
for
pathogens
perform
as
assumed
by
their
engineering
and
design
principles
could
also
be
conducted.
Determinations
could
be
made
of
pathogen
density
and
elimination
across
the
various
accepted
treatment
processes
and
in
the
biosolids
or
environmental
media
over
time,
applying
geographic
and
site­
specific
conditions
that
affect
pathogen
fate
and
transport
to
determine
the
effectiveness
of
site
restrictions,
buffer
zones,
and
holding
periods
for
Class
B
biosolids.
EPA
may
also
consider
further
refining,
and
directly
correlating,
stabilization
controls
to
outcomes
using
metabolic
techniques
(
e.
g.,
sour
test,
carbon
dioxide
metabolic
release,
methane
metabolic
release).

2.
The
Agency's
Response
to
the
Pathogen
Category
How
EPA
Plans
To
Address
NRC
Pathogen
Recommendations
EPA
currently
uses
a
technology
and
management
practices
based
approach
to
minimize
pathogen
exposure.
The
Agency
is
considering
studies
to
better
understand
the
measurement,
control,
and
fate
of
pathogens
during
the
production
and
land
application
of
sewage
sludge.
Such
studies
include
improved
analytical
methods,
evaluation
of
treatment
and
application
processes,
site­
specific
pathogen
occurrence
studies,
potential
human
health
impacts,
exposure
assessment,
and
risk
assessment.
Certain
pathogen
studies
are
discussed
in
the
Methods
Development
subsection
of
this
notice.
Where
other
studies
address
several
pathogen
issues
(
e.
g.,
field
studies,
management,
treatment,
site
restrictions),
they
are
briefly
described
below.

VerDate
Jan<
31>
2003
15:
16
Apr
08,
2003
Jkt
200001
PO
00000
Frm
00054
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
09APN1.
SGM
09APN1
17389
Federal
Register
/
Vol.
68,
No.
68
/
Wednesday,
April
9,
2003
/
Notices
Research:
EPA
has
an
ongoing
biosolids
research
program
focused
on
selected
pathogens,
and
is
expanding
this
program
during
this
fiscal
year.
Future
pathogen
research
will
be
determined
by
the
results
of
ongoing
studies
that
will
inform
the
Agency
about
significant
issues
and
information
gaps
that
require
additional
work.
Presently,
the
Agency
is
considering
research
in
at
least
three
general
areas:
(
1)
Development
of
improved
pathogen
analytical
techniques;
(
2)
assessment
of
exposure
and
risk
for
critical
pathways
and
pollutants,
and
(
3)
evaluation
of
sewage
sludge
processing
and
land
application
methods
and
site
restrictions.
Results
of
such
research
will
assist
the
Agency
in
determining
where
improvements
may
be
needed.

Pathogen
Activities
In
June
2001,
EPA
and
USDA
sponsored
a
workshop
on
``
Emerging
Pathogen
Issues
in
Biosolids,
Animal
Manures,
and
Other
Similar
By­
Products''
(
USEPA
2003
in
press).
The
workshop
assembled
experts
in
biosolids
and
animal
waste
management
to
review
the
state­
of­
the­
science,
resolve
persistent
and
complex
issues,
and
provide
suggestions
for
research.
The
workshop
considered:
viruses,
bacteria,
protozoa,
prions,
fungi,
and
helminth
ova;
migration
of
pathogens
to
groundwater
and
air
from
recycling
and
treatment
operations;
qualitative
identification
and
detection
methods
for
pathogens;
the
fate
of
antibiotics
in
animal
and
human
wastes;
pathogen
resistance
to
antibiotics;
and
susceptibility
of
people
with
immunosuppressed
conditions
to
pathogens.
A
discussion
of
recently
initiated
EPA
work
concerning
pathogens
at
five
biosolids
and
three
animal
manure
production
and/
or
application
sites
is
provided
in
the
previous
Exposure
category.
The
Agency
has
completed
and
is
conducting
additional
studies
on
exposure
and
occurrence
of
disease
which
are
described
in
the
Risk
Assessment
and
Human
Health
subsections
of
this
Section
VII.
In
a
collaboration
with
Duke
University,
EPA
has
also
published
a
report
on
the
relationship
between
odor
from
animal
and
waste
water
residuals
processing
facilities
and
land
application
sites
and
potential
health
effects
(
Journal
of
Agromedicine,
Volume
7(
1),
2000,
ISSN:
1059
 
924X).
The
report
summarizes
the
state
of
knowledge
on
ambient
odor
health
effects
with
emphasis
on
animal
manure
and
biosolids
odor
emissions.
Potential
mechanisms
for
health
symptoms,
methods
for
validating
health
symptoms,
presence
of
odor,
and
efficacy
of
odor
management
are
discussed.
The
importance
of
health
effects
was
found
to
be
dependent
upon
a
number
of
factors,
and
health
impacts
may
be
minimized
using
odor
remediation
methods.
The
University
of
Arizona's,
National
Science
Foundation,
Water
Quality
Center
(
http://
www.
wqc.
arizona.
edu)
has
conducted,
and
is
planning
to
conduct,
pathogen
studies
in
biosolids
including:
(
1)
Air
transmission
of
pathogens
from
land
application,
(
2)
potential
occurrence
of
Staphylococcus
aureus,
(
3)
fate
and
transport
of
pathogens,
and
(
4)
risk
assessments
for
pathogens
in
land
applied
biosolids.
These
studies
will
evaluate
various
application
sites,
terrain,
climate,
and
potentially
affected
nearby
populations.
The
researchers
involved
in
this
study
plan
to
model
the
transmission
of
pathogens
to
estimate
exposure
for
nearby
human
populations,
which
may
ultimately
allow
the
development
of
predictive
risk
assessment
protocols.
EPA
will
monitor
these
studies
as
they
develop
over
at
least
the
next
two
years
to
determine
their
relevance
to
the
National
biosolids
program.
EPA's
Pathogen
Equivalency
Committee
(
PEC):
The
Agency
formed
and
has
supported
the
PEC
since
1985.
PEC
members
provide
guidance
to
applicants,
permitting
authorities
and
members
of
the
regulated
community
on
sampling
and
analysis
issues
related
to
meeting
the
subpart
D
requirements
of
part
503
(
pathogen
and
vector
attraction
reduction).
The
PEC
currently
consists
of
representatives
from
EPA
and
the
Centers
for
Disease
Control
and
Prevention
(
CDC).
The
members
have
expertise
in
bacteriology,
virology,
parasitology,
wastewater
engineering,
medical
and
veterinarian
sciences,
statistics,
and
sludge
regulations.
The
PEC
evaluates
and
supports
development
of
alternative
treatment
technologies
by
consulting
with
local
communities,
States,
industry
and
others
stakeholders.
The
PEC
provides
information
on
biosolids
processes,
contaminant
occurrences,
and
exposure,
and
assists
EPA
regions,
States,
and
the
regulated
industry
with
questions
about
equivalency
for
Processes
to
Significantly
Reduce
Pathogens
(
PSRP)
and
Processes
to
Further
Reduce
Pathogens
(
PFRP)
under
40
CFR
part
257
and
part
503.
If
the
PEC
recommends
that
a
process
is
equivalent
to
PSRP
or
PFRP,
the
operating
parameters
and
any
other
conditions
critical
to
adequate
pathogen
reduction
are
specified.
The
Water
Environment
Research
Foundation
(
WERF),
with
contributions
from
EPA,
is
funding
a
diverse
research
program
to
support
the
wastewater
treatment
industry.
An
important
part
of
their
program
has
been
supporting
research
on
biosolids
that
has
been
aimed
at
reducing
uncertainties
and
hence
is
significant
with
respect
to
the
NRC
recommendations.
Treatment
plant
residuals
and
biosolids,
including
pathogen
issues,
have
consistently
ranked
among
the
top
five
priorities
for
WERF
subscribers
over
the
past
decade.
WERF
biosolids
research
entails
more
than
40
basic
and
applied
projects
to
reduce
uncertainties,
better
manage
biosolids,
assess
public
perception
of
risks,
and
develop
strategies
for
biosolids
treatment
and
management.
Much
of
WERF's
research
is
focused
on
the
beneficial
uses
of
biosolids.
The
Research
of
particular
interest
includes
methods
for
rapidly
detecting
pathogens.
EPA
plans
to
continue
to
review
and
evaluate
such
research
projects
as
they
are
completed
to
determine
their
relevancy
to
the
national
biosolids
program.
Other
studies
supported
by
WERF
are
intended
to
determine
biosolids
land
application
rates.
Phosphorus
overload
in
animal
manure
and
biosolids
is
a
particular
concern.
These
studies
are
evaluating
phosphorus
bioavailability
and
Class
A
and
Class
B
pathogens
to
determine
potential
impact
on
groundwater
and
other
environmental
media.
WERF
is
convening
a
biosolids
research
summit
in
the
summer
of
2003.
A
WERF
pre­
summit
will
provide
training
about
mutual
gains
activities
and
joint
fact
finding,
and
will
develop
a
protocol
for
guiding
the
assistance
of
an
information
sharing
group
(
comprised
of
the
concerned
citizens,
as
well
as
stakeholders)
in
recommending
WERF­
sponsored
research
and
oversight
needs.
EPA
plans
to
collaborate
with
WERF
and
the
USDA
to
sponsor
an
international
conference
on
sustainable
land
application
for
municipal
and
industrial
effluents,
manures,
biosolids
and
other
non­
hazardous
wastes.
The
conference,
scheduled
for
January
2004,
will
provide
information
and
perspectives
on
research
gaps
and
needs.
Detailed
information
on
the
WERF
biosolids
research
program
may
be
accessed
at
http://
www.
werf.
org.

Planned
Pathogen
Activities
Quantitative
Microbial
Risk
Assessment
(
QMRA):
EPA
and
WERF
are
funding
research
termed
``
QMRA'',
as
described
in
``
A
Dynamic
Model
to
Assess
Microbial
Health
Risks
Associated
with
Beneficial
Uses
of
Biosolids''
(
WERF
2003,
Cooperative
Agreement
No.
CR
 
825237).
The
organizations
involved
in
this
research
include
WERF,
the
University
of
VerDate
Jan<
31>
2003
15:
16
Apr
08,
2003
Jkt
200001
PO
00000
Frm
00055
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
09APN1.
SGM
09APN1
17390
Federal
Register
/
Vol.
68,
No.
68
/
Wednesday,
April
9,
2003
/
Notices
California
at
Berkeley,
and
Eisenberg,
Olevieri
and
Associates.
The
document
describing
this
research
also
presents
a
methodology
for
assessing
exposure
and
risks
to
human
health
from
pathogens
in
biosolids.
The
present
methodology
provides
initial
screening
for
a
given
scenario,
identifies
broad
conditions
for
high
and
low
risk
situations,
and
estimates
where
more
data
are
needed.
Future
work
(
beyond
2004)
may
focus
on
applying
this
methodology
to
more
refined
scenarios.
Such
validation
activities
will
assist
EPA
in
developing
microbial
risk
assessment
guidelines,
subject
to
available
resources.
Potential
future
pathogens
activities
will
include
analytical
methods
development,
exposure
and
risk
assessment.
The
Agency
is
also
considering
continuing
site­
specific
evaluations
of
current
treatment
and
land
application
processes,
studies
of
wastewater
treatment
sludge
stabilization
during
biosolids
production
to
reduce
odors
and
vectors,
and
the
use
of
pilot­
scale
treatment
units
to
optimize
sludge
treatment
techniques
for
pathogen
and
chemical
control.

F.
Human
Health
Studies
1.
Summary
of
Human
Health
NRC
Recommendations
The
NRC
recommended
that
the
Agency
conduct
response
incident
investigations,
targeted
exposure
surveillance,
and
well­
designed
epidemiological
investigations
of
exposed
populations.
Data
from
these
studies
would
be
used
to
provide
a
means
of
documenting
whether
health
effects
exist
that
can
be
linked
to
biosolids
exposure.
The
NRC
also
recommended
that
preplanned
exposure
assessment
studies
characterize
exposure
of
workers
and
the
general
public
who
come
into
contact
with
biosolids
either
directly
or
indirectly.
Such
studies
could
include
the
identification
of
microorganisms
and
chemicals,
the
selection
of
measurement
methods
for
field
samples,
and
the
collection
of
adequate
samples
in
appropriate
scenarios.
Further,
the
NRC
recommended
that
epidemiological
studies
of
biosolids
use
be
designed
to
provide
evidence
of
a
causal
association,
or
lack
thereof,
between
biosolids
exposure
and
adverse
human
health
effects.
These
studies
could
include
an
assessment
of
the
occurrence
of
disease
and
an
assessment
of
potential
exposures.
Because
large
scale
and
comprehensive
epidemiological
studies
are
expensive
and
require
extensive
data
analysis,
priority
could
be
given
to
studies
that
can
help
reduce
uncertainty.

2.
The
Agency's
Response
to
the
Human
Health
Studies
Category
How
EPA
Plans
To
Address
NRC
Human
Health
Studies
Recommendations
At
this
time,
the
Agency
does
not
plan
to
conduct
an
epidemiological
study,
as
discussed
in
the
NRC
report.
As
noted
by
the
NRC,
comprehensive
epidemiological
studies
are
complex,
time
consuming,
and
require
substantial
additional
funding.
The
Agency
may
assess
the
future
need
for
epidemiological
studies,
but
believes
targeted
human
health
studies
(
e.
g.,
those
of
focused
scope,
such
as
exposure
to
pollutants
via
aerial
transport
and
incident
investigations)
over
the
short­
term
might
better
address
potential
human
health
impact
and
persistent
uncertainties
surrounding
exposed
populations.
These
studies
could
help
assess
the
potential
airborne
exposure
to
pollutants
and
could
help
determine
whether
incidents
are
occurring
following
biosolids
exposure.
Targeted
exposure
and
human
health
studies
could
also
help
inform
the
design
of
any
future
epidemiological
studies,
should
they
prove
necessary.
Results
from
targeted
studies
would
also
allow
the
Agency
to
communicate
with
other
public
health­
based
federal
agencies
regarding
human
health
exposure
and
epidemiological
studies.

Planned
Human
Health
Activities
Targeted
Human
Health
Investigations:
The
Agency's
primary
objective
is
to
characterize
pollutants
and
microbial
agents
present
in
biosolids,
as
well
as
any
associated
human
exposure
pathways,
that
may
have
the
greatest
potential
to
adversely
impact
human
health.
Specifically,
the
NRC
sees
an
immediate
need
for
a
systematic
approach
for
investigating
claims
of
disease
or
illness
following
biosolids
exposure.
Regulators,
sewage
sludge
processors,
and
land
appliers
must
be
capable
of
responding
rapidly
to
such
reports.
The
Agency
is
investigating
the
possibility
of
developing
a
process
for
timely
notification,
recording,
and
tracking
incident
reports
in
collaboration
with
the
Centers
for
Disease
Control
and
Prevention
(
CDC).
The
Agency
has
initiated
preliminary
discussions
with
the
CDC
to
discuss
possible
mechanisms
for
recording
and
tracking
biosolids
related
disease
incidents.
The
University
of
Arizona's
National
Science
Foundation,
Water
Quality
Center,
may
also
join
cooperatively
in
the
USDA/
EPA/
State
of
PA
study
to
evaluate
risk
from
exposure
to
pathogens,
particulates,
endotoxins,
and
odors
from
farm
fields
and
other
agricultural
and
silvicultural
settings
upon
which
biosolids,
animal
manures,
and
other
organic
amendments
have
been
applied.
These
cooperative
studies
will
evaluate
various
application
sites,
terrain,
climate,
placements
of
receptor
populations
and
downwind
ambient
air
concentrations
of
pathogens
and
volatile
organic
chemicals
near
residents.
The
Agency
plans
to
evaluate
if
the
collected
data
can
be
used
to
develop
models
for
estimating
exposure
of
human
populations
downwind
of
these
sites,
which
might
then
be
used
in
predictive
risk
assessment
applications.

G.
Regulatory
Activities
1.
Summary
of
Regulatory
NRC
Recommendations
The
NRC
recommended
that
EPA
revise
or
develop
regulatory
criteria
for
biosolids
in
a
timely
fashion
and
identify
additional
regulatory
mechanisms
to
better
protect
human
health
and
the
environment
from
the
exposure
to
land­
applied
biosolids.
This
recommendation
includes
the
following
components:
a
review
of
biosolids
protocols
used
by
other
nations,
adoption
of
national
standard
treatment
design
criteria,
a
refinement
of
stabilization
controls
correlated
to
outcomes
using
metabolic
techniques,
development
of
molybdenum
standards,
development
of
a
quantitative
microbial
risk
assessment
(
QMRA)
to
establish
regulatory
criteria
for
pathogens,
studies
to
determine
whether
the
management
practices
specified
in
the
Part
503
rule
achieve
their
intended
effect,
provisions
for
the
distribution
of
Class
A
biosolids
weighing
less
than
1
metric
ton
(
i.
e.,
the
NRC
recommends
that
all
biosolids
sold
should
be
exceptional
quality
(
EQ)),
and
the
elimination
of
exemptions
for
nutrient
management
and
site
restrictions
for
land­
applied
EQ
biosolids.
The
NRC
also
recommended
that
EPA
consider
additional
risk­
management
practices
when
revising
the
part
503
rule.
Considerations
should
include
limitations
on
holding
or
storage
practices,
slope
restrictions,
soil
permeability
and
depth
to
groundwater,
and
setbacks
to
residences
or
businesses,
surface
water,
and
drinking
water
supplies.

VerDate
Jan<
31>
2003
15:
16
Apr
08,
2003
Jkt
200001
PO
00000
Frm
00056
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
09APN1.
SGM
09APN1
17391
Federal
Register
/
Vol.
68,
No.
68
/
Wednesday,
April
9,
2003
/
Notices
2.
The
Agency's
Response
to
the
Regulatory
Category
How
EPA
Plans
To
Address
NRC
Regulatory
Recommendations
Ongoing
Regulatory
Activities
New
Standards:
As
previously
mentioned
in
Section
II
above,
EPA
vacated
the
numeric
standards
for
molybdenum
in
sewage
sludge
as
a
result
of
litigation.
EPA
has
conducted
a
literature
search
of
new
environmental
properties
information
for
molybdenum
in
land­
applied
biosolids.
Following
review
of
this
new
information,
EPA
will
determine
its
applicability
as
the
basis
for
re­
proposing
molybdenum
standards
for
land­
applied
sewage
sludge.
EPA
is
planning
to
complete
this
review
in
2003.
EPA
also
has
information
indicating
that
virtually
no
biosolids
products
are
sold
or
given
away
in
bags
or
other
containers
unless
they
comply
with
the
pollutant
concentrations
for
the
nine
metals
currently
regulated
and
the
pathogen
and
vector
attraction
reduction
requirements,
which
allows
these
products
to
be
classified
as
exceptional
quality
(
EQ)
as
described
in
the
EPA
guidance
(
USEPA,
1994).
EPA
plans
to
evaluate
the
data
during
the
current
year
to
determine
whether
to
amend
part
503
to
eliminate
the
non­
EQ
Table
4
alternative
for
selling
and
distributing
biosolids
products
that
are
sold
or
given
away
in
bags
or
other
containers
weighing
less
than
one
metric
ton.
Standardized
Management
Practices:
Part
503
is
designed
to
protect
public
health
through
compliance
not
only
with
numerical
criteria
for
pollutants
found
in
biosolids,
but
also
with
operational
standards
for
pathogen
and
vector
attraction
reduction.
These
operational
standards
are
performance
based,
based
on
operational
goals
for
specified
reduction,
to
enable
elimination
of
pathogens
and
vector
attraction
reductions
in
sewage
sludge
through
various
engineering
designs,
processes
and
equipment.
EPA
believes
that
such
means
are
appropriate
for
achieving
environmental
performance
while
encouraging
efficient,
costeffective
and
innovative
systems
and
approaches.
The
establishment
of
national
standard
treatment
design
criteria
may
not
result
in
application
of
the
most
efficient
site­
specific
practices
for
protecting
public
health.
The
additional
management
practices
recommended
by
the
NRC
are
linked
to
site­
specific,
or
local­
level,
conditions.
Examples
include
topography,
soil
characteristics,
climate,
population
density,
land­
use,
depth
to
groundwater,
and
proximity
to
surface
waters.
States
and
local
jurisdictions
will
have
better
knowledge
of
local
conditions,
and
are
in
a
better
position
to
establish
additional
management
practices
to
augment
the
protectiveness
of
the
part
503
Standards.
However,
EPA
also
plans
to
evaluate
such
practices
to
determine
if
additional
requirements
or
improvements
in
the
Part
503
Rule
are
warranted.
Regulations
from
Other
Nations:
EPA
generally
considers
relevant
and
available
information
and
protocols
from
other
nations
to
augment
and
inform
its
decisions.
When
standards
are
available,
such
as
the
Canadian
standards
for
sewage
sludge,
these
have
provided
the
Agency
with
valuable
new
perspectives
and
insights
into
the
scientific,
technical,
and
societal
basis
for
the
development
and
implementation
of
sewage
sludge
regulations.
However,
there
are
fundamental
scientific
and
programmatic
differences
between
certain
international
sewage
sludge
standards
and
EPA's
standards
for
the
use
or
disposal
of
sewage
sludge
in
40
CFR
part
503.
The
Part
503
Standards
are
based
on
information
for
pollutants
found
in
sewage
sludge,
and
are
risk­
based
as
directed
by
section
405(
d)
of
the
Clean
Water
Act.
As
such,
the
Part
503
Standards
consist
of
numerical
limits
with
adequate
margins
of
safety
to
protect
public
health
and
the
environment.
The
Part
503
numerical
standards
are
based
on
a
conservative
set
of
exposure
pathway
and
risk
assessment
assumptions.
In
contrast,
international
sewage
sludge
standards
are
based
on
differing
legal
frameworks.
Therefore,
sewage
sludge
regulation
promulgated
by
some
other
countries
may
not
be
comparable
to
EPA's
authority
or
standards
under
section
405
of
the
CWA.
However,
numerous
other
countries
have
supported
the
quantitative
risk
assessment
approach
and
have
often
adopted
Part
503
limits
for
regulating
biosolids.

Planned
Regulatory
Activities
Studies:
As
part
of
its
field
studies
in
2004,
EPA
is
planning
to
evaluate
certain
Class
B
disinfection
processes
including
the
natural
attenuation
of
pathogens
that
occurs
while
the
sludge
is
on
or
in
the
soil
for
the
site
restriction
periods
stated
in
the
current
regulations
(
40
CFR
503.32(
b)(
5)).
Treatment
processes
that
are
expected
to
be
evaluated
include
anaerobic
digestion
and
lime
addition.
Site
restrictions
to
be
studied
include
limitations
on
how
soon
agricultural
activities
can
occur
after
biosolids
application.
In
determining
the
efficacy
of
current
management
practices,
ways
to
improve
them
may
also
be
identified.
This
research
will
be
initiated
in
2003.

H.
Biosolids
Management
4.
Summary
of
Biosolids
Management
NRC
Recommendations
The
NRC
recommended
that
the
Agency
increase
the
resources
devoted
to
its
biosolids
program
and
expand
biosolids
management
activities.
Specific
recommendations
were
made
to
increase
funding
to
States
to
implement
programs,
fund,
support,
and
officially
sanction
EPA's
Pathogen
Equivalency
Committee
(
PEC)
as
part
of
the
EPA
biosolids
program,
and
strike
a
balance
between
expending
resources
on
new
site­
specific
data
collection
and
expending
resources
to
model
and
assess
risk
using
existing
information.
The
NRC
also
recommended
biosolids
management
activities
in
the
following
areas:
expand
and
strengthen
the
oversight
program,
track
allegations
and
sentinel
events
of
adverse
health
effects
from
exposure
to
land­
applied
biosolids,
and
conduct
studies
to
determine
whether
the
management
practices
specified
in
Part
503
achieve
their
intended
effect.
Furthermore,
the
NRC
recommended
that
the
Agency
develop
a
procedural
framework
to
implement
human
health
investigations
and
to
verify
that
(
1)
treatment
technologies
for
pathogen
control
are
effective
(
quality
control),
(
2)
chemical
standards
are
met
(
compliance
audits),
and
(
3)
unanticipated
hazards
are
identified.

2.
The
Agency's
Response
to
the
Biosolids
Management
Category
How
EPA
Plans
To
Address
NRC
Biosolids
Management
Recommendations
Biosolids
Management
Activities
Overview:
At
EPA
Headquarters,
the
biosolids
regulatory
staff
within
the
Office
of
Water
has
been
increased
recently.
The
new
staff
positions
will
be
devoted
to
regulatory
development,
Part
503
updates,
and
implementation
activities.
There
is
also
an
enforcement
or
compliance
presence
in
each
of
the
EPA
Regional
Offices
for
following
up
on
phone
calls
and
complaints
received
from
the
public,
and
initiating
Agency
enforcement
actions,
as
appropriate.
States
have
their
own
oversight
programs,
some
of
which
are
quite
comprehensive.
There
are
a
total
of
about
150
full
time
equivalent
State
employees
assigned
to
their
respective
biosolids
programs.
Five
States
have
VerDate
Jan<
31>
2003
15:
16
Apr
08,
2003
Jkt
200001
PO
00000
Frm
00057
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
09APN1.
SGM
09APN1
17392
Federal
Register
/
Vol.
68,
No.
68
/
Wednesday,
April
9,
2003
/
Notices
been
authorized
by
EPA
to
administer
the
part
503
program,
and
15
additional
States
are
at
various
points
in
the
authorization
process.
National
coordination
of
State,
regional
and
Headquarters
biosolids
programs
are
achieved
via
an
annual
national
meeting.
EPA
continues
to
meet
its
statutory
obligations
under
the
Clean
Water
Act
(
CWA)
pertaining
to
sewage
sludge.
The
Agency
continues
to
believe
that
land
application
of
biosolids
is
an
appropriate
choice
for
communities,
when
conducted
in
compliance
with
EPA
regulations.
Given
present
scientific
knowledge,
EPA
has
based
the
allocation
of
resources
to
biosolids
compliance
and
enforcement
on
its
assessment
of
the
relative
risks
to
public
health
and
the
environment
that
are
posed
by
biosolids.
Regions
and
States
have
the
flexibility
and
responsibility
to
address
situations
where
compliance
assistance
and
enforcement
actions
to
address
biosolids
are
appropriate
and
necessary.
EPA
has
taken
enforcement
actions
and/
or
appropriate
administrative
remedies
to
address
biosolids
violations
of
40
CFR
part
503
and
will
continue
to
take
actions
to
address
instances
where
biosolids
pose
an
imminent
and
substantial
endangerment
to
human
health
or
the
environment.
EPA
will
reconsider
resources
devoted
to
biosolids
if
additional
research
and
science
demonstrate
greater
risk.
To
assist
the
States
and
Regions
in
their
oversight
of
the
biosolids
program,
EPA
has,
either
in
place
or
in
development,
tools
to
assist
and
promote
compliance
with
biosolids
regulatory
requirements.
The
National
Pollutant
Discharge
Elimination
System
(
NPDES)
Compliance
Inspection
Manual,
which
is
used
by
EPA
and
State
inspectors
to
perform
inspections
in
the
field,
includes
a
``
Sludge
(
Biosolids)''
chapter
(
Chapter
10).
This
manual
has
just
undergone
major
revisions
and
updating
by
a
Headquarters
and
regional
workgroup;
the
Manual
is
being
distributed
as
a
final
draft
for
regional
and
program
office
review.
Electronic
training
modules,
including
a
module
for
biosolids
inspections,
are
planned
to
be
available
shortly
after
the
release
of
the
revised
manual,
in
Summer
2003.
Additionally,
there
are
two
compliance
assistance
web
sites,
which
are
available
for
biosolids
compliance
studies,
information
and
tools,
and
for
links
to
other
sites
with
pertinent
biosolids
compliance
information.
One
is
the
National
Environmental
Compliance
Assistance
Clearinghouse
at:
http://
cfpub.
epa.
gov/
clearinghouse/.
This
site
is
a
searchable
clearinghouse
of
compliance
assistance
materials.
The
second
Web
site
is
the
Local
Government
Environmental
Assistance
Network
(
LGEAN)
at
http://
www.
lgean.
net.
This
on­
line
compliance
assistance
center,
which
focuses
on
local
government
environmental
requirements,
is
operated
by
the
International
City/
County
Management
Association
(
ICMA),
and
has
six
other
partners
representing
local
government.
In
the
area
of
data
systems,
EPA
is
continuing
to
work
with
States
as
it
modernizes
the
Permit
Compliance
System
(
PCS)
to
allow
for
more
effective
program
oversight.
While
PCS
is
the
national
data
system
for
the
NPDES
permit
program,
it
currently
requires
only
limited
biosolids
data.
As
part
of
the
PCS
modernization,
a
separate
workgroup
(
including
States
and
EPA)
was
devoted
to
the
data
needed
to
manage
the
biosolids
program.
This
workgroup
examined
data
in
State
systems,
Biosolids
Data
Management
System
(
BDMS)
and
PCS,
and
considered
incorporating
BDMS
into
PCS.
The
recommendations
of
this
workgroup,
endorsed
by
the
PCS
Executive
Council,
was
not
to
incorporate
or
link
BDMS,
but
rather
to
add
data
elements
to
PCS
to
improve
tracking
and
oversight
of
the
biosolids
program.
The
BDMS
is
another
source
of
biosolids
data.
It
was
developed
in
the
late
1990s
by
Region
VIII
to
track
biosolids
quantity,
quality,
use,
and
disposal
practices
in
the
Region
VIII
states.
While
not
the
national
system
of
record
for
biosolids,
BDMS
is
a
tool
for
municipalities
in
which
they
can
enter
data
themselves
and
use
the
BDMS
to
develop
reports
for
states,
EPA
and
for
citizen
review.
The
BDMS
is
also
a
valuable
management
tool
and
can
be
used
to
record
information
about
reported
incidences
associated
with
biosolids
land
application.
The
BDMS
is
available
at:
http://
www.
treeo.
uf/.
edu/
water/
bdmsQuestionnaire.
asp.
Current
BDMS
users
include
some
EPA
Regional
offices,
States,
users
of
biosolids,
contract
land
appliers,
and
POTWs
throughout
the
U.
S.
and
Canada.
EPA
is
continuing
to
assess
the
potential
of
upgrading
BDMS
as
a
management
tool
that
can
link
with
established
states
and
the
Federal
PCS
system.
Research
by
the
Water
Environment
Research
Foundation
(
WERF)
is
described
in
the
Pathogen
and
the
Human
Health
Studies
categories.
WERF
also
supported
a
study
by
the
New
England
Biosolids
and
Residuals
Association
(
NEBRA)
looking
at
the
importance
of
establishing
relationships
among
researchers,
federal
government
and
concerned
citizens.
This
research
included
a
survey
on
public
perceptions
and
what
people
know
about
biosolids,
what
their
concerns
are
and
whether
their
concerns
are
being
addressed
adequately.
The
study's
aim
is
to
suggest
ways
that
regulators
and
people
can
work
together.
A
report
is
due
out
by
mid
2003.
This
and
other
projects
will
help
the
Agency
gain
a
better
understanding
of
public
perception
issues,
values,
and
expectations.
EPA
can
then
identify
the
most
effective
communication
approaches
to
ensure
understanding
of
the
importance
of,
and
need
for,
proper
biosolids
management
Science
and
Public
Outreach:
Because
of
varying
resources
and
diverse
local
circumstances,
risk
communication
practices
vary
widely
throughout
the
United
States.
The
Agency's
risk
communication
programs
are
aimed
at
improving
public
awareness
of
the
issues
and
to
achieve
exposure
reductions
where
needed.
Embodied
in
all
of
the
priorities
for
action
described
in
this
biosolids
strategy
is
a
need
to
foster
public
awareness
of
the
issues
surrounding
biosolids
use
and
exposure.
Through
the
activities
and
organizations
mentioned
below,
EPA
is
committed
to
improving
the
effectiveness
of
risk
communication
methods
at
national,
regional,
and
local
levels.
An
Information­
Sharing
Group
(
ISG)
has
been
established
based
upon
the
concepts
developed
in
WERF
studies
concerning
joint
fact­
finding
research.
The
ISG
is
comprised
of
concerned
citizens,
health
scientists,
municipal
operators,
a
farmer,
biosolids
managers,
and
input
from
State
and
Federal
regulatory
agencies.
The
ISG
has
been
established
to
work
jointly
with
about
25
scientific
experts
in
a
large
cooperative
study
of
odor,
particulates,
pathogens,
and
endotoxins
in
the
air
around
biosolids
and
animal
manure
land
application
sites.
Currently
the
researchers
are
from
EPA,
USDA,
the
State
of
PA,
and
several
other
organizations.
WERF
has
efforts
underway
to
expand
the
use
of
such
information­
sharing
in
other
research
projects.
The
National
Biosolids
Partnership
(
NBP)
is
a
48
member
alliance
formed
in
1997
with
AMSA
(
Association
of
Metropolitan
Sewerage
Agencies),
WEF
(
Water
Environment
Federation,
and
EPA
(
U.
S.
Environmental
Protection
Agency).
Through
partnering
with
producers,
service
contractors,
users,
regulatory
agencies,
universities,
the
farming
community,
and
environmental
organization,
the
goal
of
the
NBP
is
to
advance
environmentally
sound
and
accepted
biosolids
management
practices.

VerDate
Jan<
31>
2003
15:
16
Apr
08,
2003
Jkt
200001
PO
00000
Frm
00058
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
09APN1.
SGM
09APN1
17393
Federal
Register
/
Vol.
68,
No.
68
/
Wednesday,
April
9,
2003
/
Notices
Through
a
voluntary
Environmental
Management
System
(
EMS),
being
developed
for
biosolids
by
the
National
Biosolids
Partnership
(
NBP),
EPA
continues
to
provide
the
public
with
educational
information,
based
on
the
best
science,
about
the
recycling
and
disposal
of
biosolids.
EPA
strongly
supports
the
ongoing
efforts
of
the
NBP
to
develop
the
EMS
and
to
provide
correct
and
timely
information
and
community­
friendly
practices
that
could
be
followed
via
its
new
communications
system.
The
EMS
program
supports
local
agencies
to
find
ways
to
meet
and
go
beyond
what
is
required
in
state
and
federal
regulations.
About
45
municipalities
are
now
pilot­
testing
their
biosolids
EMS
programs
based
upon
a
blueprint
developed
by
the
NBP.
Several
of
these
municipalities
will
be
ready
to
undergo
an
independent
third
party
audit
of
the
EMS
program
later
this
year
(
2003).
Municipalities
involved
in
the
voluntary
EMS
program
are
reporting
benefits
they
have
achieved.
They
report
that
their
participation
in
the
EMS
program
has
resulted
in
more
efficient
operation,
reduced
odors
in
biosolids,
less
intrusive
transport
of
the
biosolids
to
land
application
sites,
better
communication,
and
meaningful
involvement
of
the
public.
The
Agency
plans
to
continue
supporting
NBP
activities
and
working
with
municipalities
on
expanding
the
use
of
EMS
programs
in
biosolids
management.
Two
NBP
Web
site
address
that
present
relevant
biosolids
information
are
http://
www.
biosolids.
org
and
http://
biosolids.
policy.
net/
emsguide/
manual/
goodpractmanual.
vtml.
The
EPA's
Pathogen
Equivalency
Committee
was
discussed
in
the
Pathogens
subsection.
The
PEC
is
instrumental
in
the
development
and
evaluation
of
regulatory­
related
initiatives.
EPA
will
continue
to
support
and
evaluate
the
activities
of
the
PEC.
State
Regulations:
40
CFR
part
503
sets
minimum
standards
for
the
use
or
disposal
of
sewage
sludge.
State
requirements
may
be
more
restrictive
or
administered
in
a
manner
different
from
the
Federal
regulation.
In
all
cases,
users
and
disposers
of
biosolids
must
comply
with
the
most
restrictive
portions
of
both
the
Federal
and
State
rules.
In
most
cases,
the
part
503
rule
is
selfimplementing
users
must
comply
with
part
503
rule,
even
if
they
have
not
been
issued
a
permit
covering
sewage
sludge
use
or
disposal.
EPA
or
States
can
take
enforcement
actions
directly
against
persons
who
violate
part
503
requirements.
In
situations
where
States
and
others
are
addressing
such
issues,
EPA
plans
to
use
those
opportunities
to
further
evaluate
and
develop
the
tools
to
improve
the
assessment
and
management
of
sewage
sludge.

Planned
Biosolids
Management
Activities
The
priority
activities
for
biosolids
presented
in
this
response
were
evaluated
in
the
larger
context
of
other
Agency
priorities.
The
purpose
of
listing
planned
activities
is
to
illustrate
the
Agency's
future
direction
based
on
current
information.
Given
the
activities
spelled
out
in
this
response,
EPA's
goal
over
the
next
two
years
is
to
complete
studies
and
other
activities,
follow
external
research,
and
review
available
information.
The
Agency's
longer­
term
goal
is
to
assess
results
from
completed
and
ongoing
activities
to
determine
further
research
needs.
Implementation
of
various
activities
will
be
considered
by
the
relevant
EPA
Offices
and
Regions
in
future
priority
setting
activities.

IX.
How
Did
EPA
Conduct
the
Review
of
Part
503
Regulations
Under
the
CWA
Section
405(
d)(
2)(
C)?
Section
405(
d)(
2)(
C)
of
the
Clean
Water
Act
requires
that
EPA
review
the
sewage
sludge
regulations
``
for
the
purpose
of
identifying
additional
toxic
pollutants
and
promulgating
regulations
for
such
pollutants
consistent
with
the
requirements''
of
section
405(
d).
EPA
has
promulgated
regulations
in
40
CFR
part
503
setting
numeric
standards
for
certain
toxic
pollutants
in
sludge,
requirements
for
pathogen
and
vector
attraction
reduction,
and
operational
standards
for
emissions
from
sewage
sludge
incinerators.
As
explained
in
section
IV
above,
EPA
commissioned
the
NRC
study
of
existing
sewage
sludge
land
application
regulations
for
the
purpose
of
strengthening
the
scientific
basis
of
its
review
under
section
405(
d)(
2)(
C).
In
an
agreement
with
the
parties
in
Gearhardt
v.
Whitman,
EPA
agreed
to
publish
a
notice
seeking
public
comment
on
its
proposed
response
to
the
NRC
recommendations
and
the
results
of
its
405(
d)(
2)(
C)
review.
In
conducting
this
review,
EPA
committed
to
review
and
evaluate
publicly
available
information,
such
as
sampling
data,
scientific
studies,
and
other
analysis
and
information
taken
from
a
wide
range
of
national
and
international
public
and
private
sources.
In
fulfilling
this
commitment,
EPA
has
performed
a
comprehensive
assessment
of
the
availability
of
data
on
chemicals
that
have
been
detected
in
or
in
some
way
linked
to
sewage
sludge.
EPA
reviewed
Rounds
One
and
Two
screening
histories;
collected
and
conducted
a
preliminary
review
of
publicly
available
information
on
chemical
toxicity,
environmental
properties
such
as
mobility
and
persistence,
and
concentration;
identified
chemical
pollutants
for
which
appropriate
analytical
methods
and
human
health
benchmarks
are
available;
and
made
preliminary
determinations
regarding
sufficiency
of
information
for
risk­
based
screening
analyses.
The
results
of
this
review
are
available
in
the
docket
(
USEPA,
2003e).
At
this
time,
EPA
has
not
identified
any
additional
toxic
pollutants
that
warrant
regulation
in
sewage
sludge.
The
next
step
in
identifying
toxic
pollutants
that
may
warrant
regulation
is
to
conduct
a
screening
analysis
of
those
chemicals
for
which
adequate
data
and
analytical
methods
are
available
and
for
which
there
is
evidence
that
they
may
occur
in
sewage
sludge.
EPA
plans
to
complete
this
screening
analysis
by
January
2004.
In
addition,
EPA
is
continuing
to
seek
additional
information
to
fill
data
gaps
for
those
chemicals
for
which
adequate
data
for
the
screening
analysis
is
not
yet
available
and
would
welcome
any
relevant
data
from
commenters.
The
Agency
began
its
review
under
section
405(
d)(
2)(
C)
by
first
reviewing
the
complete
list
of
pollutants
that
were
considered
in
developing
the
Round
One
rule
and
Round
Two
proposal.
For
Round
One,
EPA
conducted
a
National
Sewage
Sludge
Survey
(
NSSS)
in
1988
 
1989,
which
included
an
analysis
of
411
pollutants.
These
411
pollutants
included,
among
others,
every
organic
chemical
including
pesticide,
dibenzofuran,
dioxin
and
PCB
analytes
for
which
EPA
had
gas
chromatography
and
mass
spectrometry
(
GC/
MS)
standards
(
58
FR
9268
 
9269).
Of
the
original
411
pollutants,
EPA
promulgated
numeric
standards
in
Round
One
for
10
pollutants
(
metals)
in
land­
applied
sewage
sludge,
three
pollutants
(
metals)
in
sewage
sludge
placed
in
surface
disposal
units,
seven
pollutants
in
sewage
sludge
fired
in
sewage
sludge
incinerators
(
SSIs),
and
an
operational
standard
for
total
hydrocarbons
(
or
alternatively
carbon
monoxide)
emitted
from
SSIs.
These
same
411
pollutants
were
the
starting
point
in
1995
for
identifying
pollutants
for
developing
a
Round
Two
regulation.
EPA
conducted
a
preliminary
screening
analysis
which
resulted
in
an
identification
of
31
pollutants
for
potential
regulation
in
Round
Two.
These
31
pollutants
were
the
subject
of
a
comprehensive
hazard
identification
study,
which
narrowed
the
list
to
dioxin,
dibenzofurans
and
VerDate
Jan<
31>
2003
15:
16
Apr
08,
2003
Jkt
200001
PO
00000
Frm
00059
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
09APN1.
SGM
09APN1
17394
Federal
Register
/
Vol.
68,
No.
68
/
Wednesday,
April
9,
2003
/
Notices
coplanar
polychorinated
biphenyls
(
PCBs).
Many
of
the
original
411
pollutants
were
eventually
eliminated
for
consideration
in
Round
One
or
Round
Two
rulemakings;
254
were
eliminated
because
they
were
not
detected
in
any
or
in
fewer
than
one
percent
of
the
sewage
sludge
samples
surveyed
in
the
NSSS,
and
others
were
dropped
because
of
a
lack
of
sufficient
information
on
their
toxicity
and
environmental
properties.
In
particular,
44
of
the
411
pollutants,
though
detected
at
a
frequency
of
greater
than
one
percent,
were
dropped
from
further
consideration
because
of
lack
of
data
on
human
health
benchmarks
and/
or
environmental
properties.
For
a
more
detailed
description
of
the
process
for
Round
One
and
Two,
see
USEPA,
2002c.
For
the
current
review,
EPA
again
started
with
the
411
pollutants
initially
identified
for
Round
One
consideration;
As
mentioned
above,
254
of
these
pollutants
were
detected
at
a
frequency
rate
of
less
than
one
percent
in
the
1988
 
89
NSSS
and
therefore
were
dropped
from
further
consideration
in
both
the
Round
One
and
Round
Two
rulemakings.
Because
the
low
detection
rates
for
these
254
pollutants
could
have
been
due
to
the
limits
of
the
analytical
and
sampling
methodology
employed
in
1988
 
89,
EPA
included
these
pollutants
in
the
current
review
for
potential
addition
to
the
Part
503
Standards.
A
literature
search
was
performed
on
these
pollutants
to
identify
(
1)
human
health
benchmarks,
(
2)
environmental
properties,
and
(
3)
their
presence
or
concentrations
in
sewage
sludge.
As
previously
mentioned,
44
of
the
411
pollutants
considered
in
the
Round
One
and
Round
Two
rulemaking
processes
were
detected
at
a
frequency
of
greater
than
one
percent,
but
were
dropped
from
further
consideration
because
of
lack
of
data
on
human
toxicity
and/
or
environmental
properties.
EPA
has
preliminarily
determined
that
23
of
the
44
are
either
non­
toxic
or
non­
persistent
in
the
environment,
but
is
continuing
to
evaluate
them.
Next,
EPA
conducted
a
literature
search
of
publicly
available
information
to
identify
information
on
pollutants
in
sewage
sludge
since
1990,
including
information
on
pollutants
that
were
not
among
the
411
originally
identified
pollutants.
EPA
has
collected
459
scientific
papers
from
national
and
international
government
entities,
universities,
non­
profit
and
other
private
entities
for
the
time
period
of
1990
 
2002,
the
date
of
the
last
NSSS
to
the
present
(
USEPA,
2002d).
Of
these
459
papers,
216
papers
concern
either
the
Round
One
or
Round
Two
pollutants
only.
The
balance
of
these
papers,
243,
concern
or
potentially
concern
pollutants
that
were
not
the
subjects
of
Rounds
One
or
Two.
Subsequently,
these
243
papers
were
reviewed
to
verify
which
of
the
papers
do
in
fact
concern
pollutants
which
were
not
the
subjects
of
Rounds
One
and
Two.
In
addition,
these
papers
were
reviewed
for
human
health
benchmarks,
environmental
properties,
and
presence
or
concentrations
of
these
pollutants
in
sewage
sludge.
EPA
also
collected
information
from
EPA
databases
and
several
other
existing
databases
with
respect
to
human
health
benchmarks,
and
found
170
pollutants
with
some
human
health
benchmarks
among
these
databases
(
USEPA,
2002e).
These
databases
include:
EPA's
Integrated
Risk
Information
System,
EPA's
Superfund
Technical
Support
Center
Provisional
Toxicity
Values,
EPA
Health
Assessment
Documents,
California
Environmental
Protection
Agency
Chronic
Inhalation
Reference
Exposure
Levels
and
Cancer
Potency
Factors,
Agency
for
Toxic
Substances
and
Disease
Registry
Minimal
Risk
Levels,
and
Health
Effects
Assessment
Summary
Tables.
The
next
step
in
this
process
was
to
ascertain
whether
analytical
methods
exist
for
detecting
and
quantifying
each
of
these
pollutants
in
sewage
sludge
(
USEPA,
2002f,
USEPA,
2002g,
USEPA,
2002h).
Although
the
accuracy,
precision,
and
limits
of
detection
of
analytical
methodologies
for
chemical
pollutants
in
the
sewage
sludge
matrix
have
significantly
improved
since
the
1988
 
89
NSSS,
there
are
still
many
pollutants
for
which
no
validated
analytical
methods
exist.
In
summary,
EPA
evaluated
publicly
available
information
with
respect
to
presence
in
sewage
sludge,
toxicity
(
including
human
health
benchmarks),
persistence,
mobility
and
potential
for
exposure
for
the
pollutants
contained
in
each
of
the
four
groups
of
pollutants
described
above:
(
1)
The
254
pollutants
with
a
low
frequency
of
detection
in
the
1988
 
89
NSSS,
(
2)
the
44
toxic
pollutants
that
were
detected
at
a
frequency
of
greater
than
one
percent
in
the
1988
 
1989
NSSS,
but
that
had
insufficient
information
to
be
able
to
perform
subsequent
evaluation,
(
3)
the
pollutants
that
were
not
the
subject
of
Rounds
One
or
Two
but
are
covered
in
the
243
papers
that
turned
up
in
the
literature
search,
and
(
4)
the
170
pollutants
for
which
some
health
benchmark
exists
in
the
literature.
These
four
groups
of
pollutants
as
described
above
were
compared
to
eliminate
any
duplicates.
Finally,
EPA
evaluated
all
of
these
pollutants
to
determine
whether
there
are
sufficiently
accurate
and
precise
analytical
methodologies
with
adequate
detection
limits
for
these
pollutants
in
the
sewage
sludge
matrix.
These
results
are
available
in
detail
in
the
docket
for
this
notice
(
USEPA,
2003b).
These
preliminary
results
will
be
further
analyzed,
leading
to
a
risk­
based
screening
analysis.
The
criteria
for
determining
whether
to
proceed
to
a
screening
analysis
for
any
pollutant
are
whether
there
are:
(
1)
Adequate
and
reliable
data
regarding
concentration
of
the
pollutant
in
sewage
sludge,
(
2)
a
current
human
health
benchmark,
(
3)
adequate
information
on
environmental
properties,
such
as
persistence
and
mobility,
and
(
4)
an
appropriate
analytical
method
for
the
pollutant.
In
evaluating
item
2
above,
EPA
will
focus
initially
on
chemicals
for
which
there
is
a
current
peer­
reviewed
human
health
benchmark
developed
by
EPA.
EPA
will
next
determine
the
adequacy
of
the
available
environmental
properties
data
for
use
in
the
risk­
based
screening
analysis.
The
results
of
this
screening
analysis
will
serve
as
a
basis
for
determining
whether
additional
toxic
pollutants
should
be
considered
for
regulation
in
sewage
sludge
under
section
405(
d)
of
the
Clean
Water
Act.
As
noted
above,
EPA
has
not
yet
identified
any
additional
pollutants
for
regulation.
Inclusion
in
the
results
presented
today
does
not
mean
that
a
pollutant
has
been
determined
to
be
present
in
sewage
sludge
in
concentrations
that
may
adversely
affect
human
health
or
the
environment.
Some,
or
even
all,
of
these
chemicals
that
have
been
detected
in
sewage
sludge
may
only
be
present
infrequently
or
in
trace
amounts,
and
may
not
present
a
risk
of
adverse
effects
to
human
health
or
the
environment.
Also,
the
properties
or
degree
of
toxicity
of
such
chemicals
may
make
their
presence,
even
in
higher
amounts,
of
little
risk
to
human
health
or
the
environment.
As
noted
above,
the
NRC
concluded
that
while
there
are
significant
data
gaps,
there
is
currently
no
documented
scientific
evidence
that
the
existing
Part
503
regulations
have
failed
to
protect
public
health.
These
results,
however,
are
an
important
step
forward
in
that
they
identify
chemicals
for
which
sufficient
new
information
exists
to
proceed
to
a
risk­
based
screening
analysis,
as
well
as
data
gaps
that
must
be
filled
for
other
chemicals
before
such
a
screening
analysis
can
be
conducted.

VerDate
Jan<
31>
2003
15:
16
Apr
08,
2003
Jkt
200001
PO
00000
Frm
00060
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
09APN1.
SGM
09APN1
17395
Federal
Register
/
Vol.
68,
No.
68
/
Wednesday,
April
9,
2003
/
Notices
EPA
expects
to
complete
its
riskbased
screening
analysis
of
chemicals
for
which
adequate
information
is
currently
available
by
January
2004.
At
that
time
EPA
will
identify
those
pollutants,
if
any,
for
which
EPA
plans
to
initiate
a
rulemaking
under
section
405(
d).
EPA
requests
comment
on
the
methodology
and
results
to
date
of
its
review
under
section
405(
d)(
2)(
C)
of
the
CWA.
EPA
also
requests
information
that
may
help
to
fill
data
gaps
for
those
chemicals
for
which
sufficient
information
is
not
yet
available
to
conduct
a
risk­
based
screening
analysis.

X.
What
Are
the
Primary
Issues
for
Public
Comment?
While
the
EPA
is
requesting
comments
on
all
of
the
information
discussed
in
this
Notice,
the
Agency
hopes
that
the
public
comment
will
also
focus
specifically
on
the
following
aspects
of
this
Notice:
1.
The
Agency's
preliminary
strategy
for
responding
to
the
NRC
Recommendations,
given
that
the
Agency's
biosolids
program
does
not
have
sufficient
resources
to
implement
all
of
the
recommendations.
2.
EPA
requests
comment
on
its
review
under
section
405(
d)(
2)(
C)
of
the
CWA.
EPA
also
requests
information
that
may
help
to
fill
data
gaps
for
those
chemicals
for
which
sufficient
information
is
not
yet
available
to
conduct
a
risk­
based
screening
analysis.
3.
EPA's
plan
to
investigate
the
possibility
of
developing
a
process
for
timely
notification,
recording,
and
tracking
incident
reports
in
collaboration
with
other
health­
based
Federal
agencies,
such
as
the
Centers
for
Disease
Control
and
Prevention.
4.
The
Agency's
plan
to
begin
designing
a
survey
using
information
obtained
from
published
pollutant
occurrence
and
effects
data,
State
occurrence
data
bases,
and
input
received
during
the
public
comment
period.

XI.
References
NRC,
1996.
Use
of
Reclaimed
Water
and
Sludge
in
Food
Crop
Production.
The
National
Academies
Press.
Washington,
DC.
Available
online
at
http://
www.
nap.
edu/
catalog/
5175.
html
NRC,
2002.
Biosolids
Applied
to
Land;
Advancing
Standards
and
Practices,
National
Research
Council
of
the
National
Academies.
The
National
Academies
Press.
Available
online
at
http://
search.
nap.
edu/
books/
0309084865/
html.
University
of
Arizona,
National
Science
Foundation,
Water
Quality
Center,
within
the
Environmental
Research
Laboratory.
Several
studies
ongoing.
Ian
L.
Pepper,
Director.
Tuscon,
Arizona.
USEPA,
1994.
A
Plain
English
Guide
to
the
EPA
Part
503
Biosolids
Rule.
190
pages.
Office
of
Water,
Office
of
Wastewater
Management.
Available
online
at:
http://
www.
epa.
gov/
owm/
mtb/
biosolids/
503pe/
index.
htm.
USEPA,
1996.
Technical
Support
Document
for
the
Round
Two
Sewage
Sludge
Pollutants.
EPA
 
822­
R
 
96
 
003.
Office
of
Water.
Washington,
DC.
August,
1996.
USEPA,
2002a.
Compilation
of
National
Research
Council
(
NRC)
Recommendations
on
Biosolids
and
EPA
Responses
and
Activities.
9
pages.
Office
of
Water,
Office
of
Science
and
Technology.
Washington,
DC.
USEPA,
2002b.
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
the
Environmental
Protection
Agency.
EPA
260R
 
02
 
008.
Office
of
Environmental
Information.
Washington,
DC.
October
2002.
Available
online
at
Http://
www.
epa.
gov/
oei/
qualityguidelines.
USEPA,
2002c.
Screening
History
for
the
Part
503
Rounds
One
and
Two
Proposal.
4
pages.
Office
of
Water,
Office
of
Science
and
Technology.
Washington,
DC.
USEPA,
2002d.
Literature
Search
of
Publicly
Available
Information
to
Identify
Information
on
Pollutants
in
Sewage
Sludge
Since
1990.
48
pages.
Office
of
Water,
Office
of
Science
and
Technology.
Washington,
DC.
USEPA,
2002e.
Human
Health
Benchmarks
for
Potential
Constituents
in
Biosolids.
11
pages.
Office
of
Water,
Office
of
Science
and
Technology.
Washington,
DC.
USEPA,
2002f.
List
of
Analytes
from
the
1989
National
Sewage
Sludge
Survey
Found
in
Less
than
1%
of
the
Samples.
7
pages.
Office
of
Water,
Office
of
Science
and
Technology.
Washington,
DC.
USEPA,
2002g.
Summary
of
Analytes
from
the
1989
National
Sewage
Sludge
Survey.
12
pages.
Office
of
Water,
Office
of
Science
and
Technology.
Washington,
DC.
USEPA,
2002h.
Potential
Analytes.
5
pages.
Office
of
Water,
Office
of
Science
and
Technology.
Washington,
DC.
USEPA,
2003a.
In
press.
Contemporary
Perspectives
on
Infectious
Disease
Agents
In
Sewage
Sludge
and
Manure.
Compost
Science
&
Utilization/
The
JG
Press,
Inc.
USEPA,
2003b.
Candidate
Pollutants
for
Ongoing
Sewage
Sludge
Evaluation.
15
pages.
Office
of
Water,
Office
of
Science
and
Technology.
Washington,
DC.
WERF,
2003.
Dynamic
Model
to
Assess
Microbial
Health
Risks
Associated
with
Beneficial
Uses
of
Biosolids.
Cooperative
Agreement
No.
CR
 
825237.
Alexandria,
VA.

Dated:
April
2,
2003.
G.
Tracy
Mehan
III,
Assistant
Administrator,
Office
of
Water.
[
FR
Doc.
03
 
8654
Filed
4
 
8
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
FEDERAL
COMMUNICATIONS
COMMISSION
[
MM
Docket
No.
98
 
204;
DA
03
 
1046]

Interim
Policy
Concerning
Placement
of
Equal
Employment
Opportunity
Public
File
Report
in
a
Broadcaster's
Public
File
AGENCY:
Federal
Communications
Commission.
ACTION:
Notice.

SUMMARY:
In
this
document,
the
Commission
gives
notice
of
its
interim
policy
concerning
the
deadline
for
placement
of
Equal
Employment
Opportunity
public
file
reports
in
stations'
public
files.
This
document
also
gives
notice
of
groups
that
have
filed
petitions
for
reconsideration
in
this
matter
regarding
requirement
modifications.

ADDRESSES:
Federal
Communications
Commission,
445
12th
Street,
SW.,
Washington,
DC
20554.

FOR
FURTHER
INFORMATION
CONTACT:
Lewis
Pulley
(
202)
418
 
1456,
or
Roy
Boyce
(
202)
418
 
1438,
Policy
Division,
Media
Bureau.

SUPPLEMENTARY
INFORMATION:
This
is
a
summary
of
the
Commission's
Public
Notice,
MM
Docketa
No.
98
 
204,
adopted
and
released
March
31,
2003.
The
complete
text
of
this
Public
Notice
is
available
for
inspection
and
copying
during
normal
business
hours
in
the
FCC
Reference
Center,
Room
CY
 
A257,
445
12th
Street,
SW.,
Washington,
DC
and
may
also
be
purchased
from
the
Commission's
copy
contractor,
Qualex
International,
Portals
II,
445
12th
Street
SW.,
Room
CY
 
B
 
402,
Washington,
DC
20554,
telephone
(
202)
863
 
2893,
facsimile
(
202)
863
 
2898,
or
via
email
qualexint@
aol.
com.

Synopsis
of
Public
Notice
1.
By
this
Public
Notice
the
Media
Bureau
establishes
an
interim
policy
concerning
the
enforcement
of
the
requirement
of
the
Equal
Employment
Opportunity
(``
EEO'')
rule
 
§
73.2080
 
that
a
broadcaster
that
is
part
of
an
employment
unit
with
five
or
more
full­

VerDate
Jan<
31>
2003
15:
16
Apr
08,
2003
Jkt
200001
PO
00000
Frm
00061
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
09APN1.
SGM
09APN1