Document ID: EPA-HQ-OW-2003-0006-0169
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-12-31T05:00Z

USEPA,
2003d
Response
to
Public
Comments
Document
Comments
Received
and
EPA
Responses
on
EPA's
Draft
Response
to
the
NRC's
Recommendations
and
EPA's
Preliminary
Results
on
the
Identification
of
Additional
Pollutants
under
Section
405(
d)(
2)(
c)
of
the
Clean
Water
Act
­
By
Comment
Topic
Category
and
Commenter
Category
U.
S.
Envrionmental
Protection
Agency
Office
of
Water
Office
of
Science
and
Technology
December
19,
2003
USEPA,
2003d
1
Comment
Response
Outline
by
Topic
TOPIC
A.
SURVEY
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2
TOPIC
B.
EXPOSURE
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20
TOPIC
C.
RISK
ASSESSMENT
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31
TOPIC
D.
METHODS
DEVELOPMENT
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53
TOPIC
E.
PATHOGENS
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59
TOPIC
F.
HUMAN
HEALTH
STUDIES
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75
TOPIC
G.
REGULATORY
ACTIVITIES
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98
TOPIC
H.
BIOSOLIDS
MANAGEMENT
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126
TOPIC
I.
GENERAL
OR
OVERARCHING
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159
TOPIC
J.
HOW
DID
EPA
CONDUCT
THE
REVIEW
OF
PART
503
REGULATIONS
UNDER
CWA
SECTION
405(
D)(
2)(
C)?
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186
TOPIC
K.
OTHER
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205
USEPA,
2003d
2
TOPIC
A.
SURVEY
Summary
Response
As
described
in
today's
Federal
Register
notice
(
Project
5),
EPA
has
concluded
that
undertaking
a
targeted
survey
is
at
present
more
useful
than
conducting
a
comprehensive
survey
modeled
on
the
1988­
89
National
Sewage
Sludge
Survey
(
NSSS).
Some
commenters
liked
the
targeted
survey
approach,
but
most
commenters
requested
that
EPA
consider
another
national
full­
scale
survey
and
made
suggestions
as
to
which
pollutants
should
be
included,
or
excluded,
from
such
a
survey.
Pending
results
of
ongoing
research
projects
and
regulatory
review,
EPA
will
design
and
conduct
a
targeted
survey
of
select
chemical
pollutants.
Microbial
pollutants
(
pathogens)
in
sewage
sludge
may
also
be
included,
depending
on
availability
of
resources
and
adequacy
of
methods.
A
survey
may
provide
feedback
for
updating
the
science
and
technology
of
sewage
sludge
applied
to
land,
disposed
of
in
a
surface
disposal
unit,
or
incinerated.
The
new
concentration
data
would
be
used
to
assess
human
and
ecological
risk
of
identified,
unregulated
pollutants
found
in
sewage
sludge
and
identify
pollutants
for
potential
regulation.
EPA
is
committed
in
FY
2005
to
starting
a
limited
analytical
survey
of
chemical
pollutants
found
in
sewage
sludge.
EPA
expects
this
survey
to
address
the
pollutants
identified
by
the
exposure
and
hazard
screening
assessment
as
presenting
a
potential
hazard,
as
identified
in
the
current
section
405(
d)(
2)(
C)
biennial
review.
The
Agency
will
evaluate
the
extent
to
which
methodology
will
allow
expansion
of
the
survey
scope
within
available
resources
to
include
additional
pollutants
(
e.
g.,
the
survey
may
also
include
metals
regulated
in
Round
One
using
improved
methods
while
surveying
for
new
metals
identified
as
presenting
a
potential
hazard
in
the
current
review).
See
Section
X
of
today's
FR
notice
for
a
list
of
these
pollutants.
Furthermore,
the
results
of
current
research
projects
may
help
determine
the
scope
of
a
survey.
The
survey
design
and
pollutants
to
be
included
in
the
survey
may
be
influenced
based
on
factors
that
include:
°
whether
to
survey
pollutants
that
were
not
previously
detected
in
sewage
sludge,
but
where
new
or
improved
methods
are
available
and
other
data
may
indicate
a
potential
for
hazard,
°
whether
to
survey
pollutants
with
reported
occurrences
in
sewage
sludge
from
other
countries
only
(
i.
e.,
not
studied
in
U.
S.
sewage
sludge),
°
whether
to
include
pathogens,
and
°
whether
to
include
pollutants
with
a
high
indication
of
potential
hazard
when
the
scientific
basis
of
the
human
health
benchmarks
in
IRIS
or
OPP
databases
for
these
pollutants
is
in
the
process
of
reassessment.
EPA
will
design
the
survey
starting
in
FY
2005.
The
Agency
will
seek
stakeholder
involvement
in
the
design
and
implementation
of
the
survey.

Academia
EPA
Log
#
51:
Ellen
Z.
Harrison
USEPA,
2003d
3
Comment
EPA
proposes
"
a
less
comprehensive,
more
targeted
survey"
to
be
accomplished
by
reviewing
existing
sources
of
info
(
published
literature,
state
data,
pubic
input).
It
makes
sense
to
compile
existing
data
prior
to
undertaking
a
new
survey.

In
the
area
of
toxic
organic
chemical
concentrations
in
sludges,
CWMI
has
compiled
the
available
data
from
a
literature
survey
and
from
reports
that
could
be
found
(
see
Harrison
and
Oakes,
2003,
Organics
survey,
unpublished
data).
A
query
to
AMSA
and
WERF
failed
to
locate
any
industry­
sponsored
data
except
for
the
AMSA
dioxin
survey.
CWMI
found
data
from
a
couple
of
states
(
NH
and
VT).
A
request
for
assistance
in
locating
data
from
other
states
was
placed
with
the
state
biosolids
coordinator
from
Wisconsin
who
represents
the
states
to
EPA.
So
far
no
other
state
data
has
been
brought
forward.

Examination
of
the
data
which
were
compiled
indicates
that
for
some
sludges,
concentrations
of
particular
toxic
organic
chemicals
found
in
sludges
exceed
the
Superfund
soil
screening
levels
(
SSLs)
(
EPA,
2001).
SSLs
are
published
for
71
of
the
291
toxic
organics
detected
in
the
36
studies
that
were
included
in
the
CWMI
study.
Of
those
71
chemicals
for
which
there
are
SSLs,
61
toxic
organic
chemicals
were
found
in
one
or
more
sludges
above
an
SSL.
Thus
under
Superfund,
a
site
specific
RA
to
evaluate
the
need
for
remedial
action
would
be
triggered
if
the
concentration
of
the
chemical
in
the
soil
at
the
Superfund
site
was
the
same
as
the
concentration
found
in
the
sludge
sample.
Of
the
291
toxic
organics
reported,
there
were
RfDs
for
68.
18
had
SSLs
but
no
RfD,
18
had
an
RfD
but
no
SSL.
Thus
there
are
toxicity
data
for
a
number
of
toxic
organic
chemicals
detected
in
sludges.
The
fact
that
there
are
concentrations
of
toxic
organics
in
sludges
that
exceed
soil
screening
levels
indicates
a
need
to
collect
more
data
on
the
concentration
of
these
toxic
organic
chemicals
in
sludges
(
a
survey)
and
to
assess
the
risks
posed
by
those
toxic
organic
chemicals
in
sludges.

EPA
does
not
seem
to
recognize
the
inadequacy
of
the
National
Sewage
Sludge
Survey
(
NSSS)
data
(
USEPA,
1990).
(
p.
17384­
5).
The
document,
for
example,
fails
to
mention
limits
of
detection
problems
with
NSSS.
As
pointed
out
in
the
NRC
report
and
Figures,
for
some
of
the
toxic
organic
chemicals
in
the
NSSS,
the
limits
of
detection
for
all
samples
were
higher
than
the
soil
screening
levels
(
SSLs
were
used
by
the
NRC
as
a
guide
for
what
concentration
might
warrant
examination
of
risks).
Analytic
issues
resulted
in
non­
detects
for
many
chemicals
in
the
NSSS
and
in
a
number
of
cases
the
limit
of
detection
exceeded
health
benchmarks.
Thus
the
basing
of
any
regulatory
measures
(
such
as
eliminating
a
chemical
from
consideration)
based
on
the
percentage
of
sludges
in
which
the
chemical
was
detected
is
absurd.
Yet
EPA
continues
to
propose
non­
detect
as
a
screen
(
though
dropping
it
to
"
not
detected
in
more
than
1%
of
samples").
Rather
EPA
should
compare
limit
of
detection
with
health
benchmark
to
see
if
a
chemical
that
was
not
detected
might
nonetheless
pose
a
health
risk.

The
NRC
report
also
mentions
some
specific
classes
of
chemicals
like
pharmaceuticals,
PBTs,
odorants,
and
metal
species
that
that
should
be
monitored
and
evaluated.
EPA
does
not
significantly
address
these
in
the
April
9
document.
USEPA,
2003d
4
The
NRC
report
addresses
odorants
in
sludges
and
recognized
the
lack
of
data
both
on
the
odorant
chemicals
in
sludges
and
their
potential
to
cause
symptoms.
The
NRC
recognized
that
odor
is
not
simply
an
esthetic
issue,
but
can
lead
to
symptoms
including
"
levels
of
tension,
depression,
anger,
fatigue,
and
confusion
(
Schiffman
et
al.
1995).
Mood
impairments
and
stress
can
potentially
lead
to
physiological
and
biochemical
changes
with
subsequent
health
consequences
(
Shusterman
et
al.
1991;
Cohen
and
Herbert
1986).
In
addition,
conditioned
responses
(
behavioral
and
physiological)
can
be
developed
to
odors
perceived
to
be
associated
with
health
symptoms
(
Bolla­
Wilson
et
al.
1988;
Shusterman
et
al.
1988)"
(
NRC,
2002,
p.
231).
EPA
needs
to
investigate
the
presence
of
odorants
in
sludges,
how
to
minimize
them,
and
how
odors
are
related
to
illness.

Response
Please
see
Summary
Response
above
which
provides
an
explanation
why
EPA
has
decided
on
a
limited
analytical
survey
of
chemical
pollutants
found
in
sewage
sludge
to
be
initiated
in
2005.

EPA
will
design
the
survey
starting
in
FY
2005
after
further
analysis
of
the
pollutants
identified
in
Sections
VIII
­
X
in
today's
notice
are
complete
and
pollutants
have
been
identified
as
candidates
for
regulation.
The
survey
will
provide
updated
concentration
data
for
use
in
a
more
refined
risk
assessment
before
proposing
a
regulation.

EPA
performed
an
extensive
literature
search
for
analytical
data
of
pollutants
found
in
sewage
sludge
from
the
period
of
1990
(
the
date
of
the
first
National
Sewage
Sludge
Survey
)
to
2002.
EPA
has
also
received
the
analytical
data
base
provided
by
the
Cornell
Waste
Management
Institute
and
EPA
extends
its
appreciation.
However,
these
data
and
the
data
that
were
found
in
the
literature
search
were
not
sufficient
to
be
considered
a
statistically
random
analytical
survey
of
the
Nation's
sewage
sludge
using
up­
to­
date
analytical
methodologies.
Therefore,
as
described
above,
EPA
is
committing
to
perform
a
third
targeted
National
Sewage
Sludge
Survey.

The
commenter
is
in
error
in
equating
various
pollutant
soil
cleanup
standards
to
concentrations
of
these
same
pollutants
in
sewage
sludge.
The
concentrations
of
pollutants
in
soils
as
a
result
of
sewage
sludge
addition
to
the
receiving
soils
is
significantly
less
than
the
concentrations
of
the
pollutants
in
the
original
sewage
sludge
based
on
the
large
dilution
that
occurs.

EPA
does
recognize
that
the
1988­
89
NSSS
had
limitations.
Certainly,
the
analytical
procedures
that
will
be
employed
in
the
targeted
survey
will
have
improved
analytical
detection
limits.

The
targeted
analytical
survey
will
gather
analytical
data
on
pollutants
that
failed
the
exposure
and
hazard
screening
assessment.
Other
pollutants
with
a
high
indication
of
hazard
may
be
included
subject
to
funds
availability.

With
respect
to
odor­
causing
substances
in
sewage
sludge,
Project
4
"
Field
Studies
of
Application
of
Treated
Sewage
Sludge"
in
Section
VII
B
of
today's
FR
notice
describes
the
USEPA,
2003d
5
studies
EPA
will
initiate
to
measure
microbial,
chemical,
and
particulate
emissions
from
sewage
sludge
land
application
sites.
Items
that
will
be
investigated
include
the
characterization
of
odorcausing
substances
with
the
aim
of
developing
strategies
for
their
control.

Citizens
EPA
Log
#
8:
David
A.
Burrows
Comment
The
studies
done
at
the
University
of
Arizona
need
to
be
repeated
in
a
variety
of
climatic
conditions.
(
Federal
Register
p.
17385)

Studies
devoted
to
methods
development
and/
or
validation
studies
for
enteric
viruses
point
to
the
need
for
a
quick
response
team
that
can
rapidly
assess
threats
from
emerging
pathogens
such
as
SARS
which
might
be
present
in
biosolids.
(
Federal
Register
p.
17385)

On
page
17385
of
the
Federal
Register
it
states
that
because
of
cost
"
the
Agency
may
only
be
able
to
measure
a
limited
number
of
pollutants."
All
pollutants
known
to
be
a
health
risk
and
present
in
biosolids
should
be
measured.

Response
The
studies
at
the
University
of
Arizona
have
been
repeated
in
a
variety
of
climatic
conditions
Researchers
studied
sewage
sludge
and
bioaerosol
samples
from
15
sites
across
the
US
that
were
applying
sewage
sludge
to
land
after
it
had
been
processed
at
full­
scale
treatment
plants
(
Rusin
et
al.
2003).
Please
refer
to
the
Summary
Response
in
the
beginning
of
this
Topic
for
the
rationale
for
a
targeted
survey.

Project
3
(
Methods
Development,
Optimization,
and
Validation
for
Microbial
Pollutants
in
Sewage
Sludge)
in
today's
Federal
Register
Notice
describes
EPA's
program
for
developing
and
standardizing
microbial
analytical
protocols
for
Ascaris
ova,
viruses,
fecal
coliforms
and
Salmonella,
to
significantly
improve
EPA's
capability
for
quantifying
microbials
in
both
sewage
sludge
and
ambient
media.
There
is
so
far
no
indication
that
biosolids
carry
the
pathogen
that
cause
Severe
Acute
Respiratory
Syndrome
(
SARS).

With
respect
to
the
commenter's
third
paragraph,
the
targeted
analytical
survey
will
gather
analytical
data
on
pollutants
that
failed
the
pollutant
screen
and,
subject
to
funds
availability,
other
pollutants
with
a
high
indication
of
potential
hazard
as
outlined
in
the
response
to
EPA
Log
#
51.

EPA
Log
#
29:
Henry
J.
Staudinger
Comment
A.
Failure
to
Adequately
Identify
Harmful
Constituents
is
a
Fatal
Defect
It
has
long
been
incomprehensible
to
those
who
have
become
ill
after
being
forcibly
exposed
to
biosolids
that
a
list
of
the
constituents
in
biosolids
remains
unavailable,
effectively
making
it
impossible
for
those
exposed
to
take
necessary
steps
to
protect
themselves,
or
for
medical
doctors
USEPA,
2003d
6
to
determine
the
cause
of
the
illnesses
or
to
determine
how
to
best
treat
them
 
or
even
to
scientifically
document
biosolids
as
the
cause
of
the
illnesses.

It
is
also
inconceivable
that
without
knowing
the
pollutants
in
given
biosolids
that
EPA
continues
to
claim
they
are
safe
when
applied
in
accordance
with
Part
503.
It
is
patently
absurd
for
EPA
to
make
safety
claims
when
members
of
the
public
become
ill
following
exposure
to
biosolids
and
the
constituent
pollutant
information
is
unknown.

NRC
recommends
that
this
serious
flaw
be
addressed
through
a
new
National
Survey
together
with
targeted
studies.

EPA's
rejects
the
National
Survey,
but
says
it
is
willing
to
consider
a
targeted
survey
based
on
biosolids
literature
and
other
unidentified
studies
that
may
be
conducted.
EPA
makes
no
commitment
to
implement
its
strategy.
In
any
event,
the
strategy
is
premised
on
the
erroneous
assumptions
that
Part
503
is
adequate;
that
all
biosolids
are
applied
in
compliance
with
Part
503
and
that
independent
studies
can
be
found
in
biosolids'
literature.

The
National
Survey
is
an
important
preliminary
step
in
anticipation
of
meaningful
targeted
surveys.
In
light
of
the
60,000
to
100,000
potential
constituents,
the
number
must
be
reduced
in
order
for
studies
to
be
practical.
However,
EPA
refuses
to
scientifically
determine
which
of
those
many
pollutants
can
be
present
in
biosolids.
Thus
EPA
has
no
way
of
determining
levels
of
many
constituents
that
could
adversely
affect
human
health
and
the
environment.

Once
the
pollutants
have
been
identified,
targeted
studies
must
be
undertaken
to
determine
the
highest
reasonable
quantity
of
each
such
pollutant
and
the
risks
of
exposure
thereto.
Targeted
investigations
and
biosolids
testing
following
credible
health
complaints
are
a
critical
part
of
that
process
in
light
of
the
complexity
of
biosolids,
and
the
possibility
that
applications
may
not
be
in
compliance
with
Part
503.

Response
Please
see
Summary
Response
and
EPA's
response
to
Log
No.
51
EPA
Log
#
31:
David
L.
Lewis
Comment
Contradictory
conclusions
set
forth
by
Synagro
include:
°
EPA
should
not
conduct
a
new
survey
of
chemical
contaminants
in
sewage
sludge.
If
it
does,
however,
all
"
new
data'
must
meet
stringent
QA/
QC
requirements
specified
by
the
Data
Quality
Act.
On
the
other
hand,
"
old
data"
collected
from
compliance
reports
at
wastewater
treatment
facilities
(
which
the
EPA
IG
concluded
are
largely
unmonitored)
would
be
okay.

Response
EPA
thank
the
commenter
for
the
views
and
information
provided.

EPA
Log
#
40:
Thomas
F.
Albert
USEPA,
2003d
7
Comment
#
13:
On
page
17385
EPA
begins
to
respond
to
one
of
the
4
overarching
recommendations
of
the
NRC
report,
which
urges
EPA
to
"
Conduct
a
new
national
survey
of
chemicals
and
pathogens
in
sewage
sludge"
(
seen
on
page
4
of
NRC
report).
EPA
responds
on
page
17385
with
a
statement
that
should
make
readers
question
the
competency
of
the
EPA
staff.
EPA
states
"
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."
How
could
anyone
state
that
such
a
survey
MAY
provide
useful
information?
The
word
MAY
is
not
appropriate.
Such
a
survey
will
surely
provide
useful
information.
The
word
MAY
should
be
replaced
with
WILL.

Comment
#
14:
In
the
first
two
paragraphs
(
31
lines)
on
page
17385
that
describe
how
EPA
plans
to
address
NRC
Survey
Recommendation,
EPA
uses
the
word
MAY
at
least
5
times.
Seems
like
there
is
a
lot
of
"
may"
in
what
EPA
plans
to
do.
When
the
section
is
finalized,
many
of
the
"
mays"
should
be
changed
to
more
definitive
words,
such
as
the
obvious
instance
noted
in
Comment
#
13.

Comment
#
15:
On
page
17385
EPA
mentions
that
"
The
University
of
Arizona
is
conducting
research
on
airborne
pathogen
exposure
at
various
times
and
distances
from
biosolids
application
sites."
Was
the
design
of
the
Arizona
study
peer
reviewed?
Will
the
draft
final
report
be
peer
reviewed?
If
EPA
goes
to
the
trouble
to
tell
readers
about
the
ongoing
Arizona
study,
why
doesn't
EPA
cite
the
important
study
by
Dowd
et
al.
"
Bioaerosol
transport
modeling
and
risk
assessment
in
relation
to
biosolid
placement''
that
appeared
in
2000
in
the
Journal
of
Environmental
Qualtiy?
The
Dowd
study
clearly
points
out
the
"
downwind"
health
risks
to
nearby
residents.

Comment
#
16:
On
page
17385
EPA
notes
that
"
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."
This
timid
statement
seems
to
be
an
EPA
response
to
one
of
the
4
overarching
recommendations
in
the
NRC
report
(
page
4)
that
urges
EPA
to
"
Conduct
a
new
national
survey
of
chemicals
and
pathogens
in
sewage
sludge."
The
EPA
response
only
mentions
that
it
is
"
proposing
to
design",
why
doesn't
EPA
say
that
it
WILL
design?
EPA
mentions
that
its
effort
will
be
a
"
targeted
approach",
what
does
"
targeted
approach"
mean?
It
probably
means
that
only
a
few
pollutants
will
be
looked
for.
EPA
should
clearly
state
its
intent
and
not
use
vague
wording.
EPA
only
mentions
"
pollutants"
(
presumably
chemicals)
for
the
"
targeted
approach."
Does
this
mean
that
there
will
be
no
survey
for
pathogens?
If
EPA
plans
to
ignore
the
NRC
overarching
recommendation
regarding
a
national
sludge
survey
for
PATHOGENS,
then
EPA
should
so
state.
If
EPA
will
NOT
survey
for
pathogens,
then
it
is
ignoring
one
of
the
NRC
report's
primary
recommendations.

Response
With
respect
to
the
commenter's
first
two
paragraphs,
in
response
to
public
comments
on
the
draft
April
2003
FR
Notice,
we
attempted
in
this
final
response
to
provide
more
detail
on
specific
activities
or
research
and
to
better
describe
how
those
activities
address
either
areas
of
uncertainty
identified
in
the
NRC
report,
or
areas
the
Agency
believes
will
improve
the
sewage
USEPA,
2003d
8
sludge
program.
EPA
believes
that
the
commenter's
objections
to
the
use
of
the
word
"
may"
has
been
addressed.

The
University
of
Arizona
study
that
reports
on
the
absence
of
Staphylococcus
Aureus
has
been
peer
reviewed
and
recently
published
(
Rusin
et
al.
ES&
T,
2003,
37:
4027­
4030).
EPA
is
aware
of
the
paper
by
Dowd
et
al.
(
Bioaerosol
Transport
Modeling
and
Risk
Assessment
in
Relation
to
Biosolids
Placement,
JEQ,
2000,
29:
343­
348),
also
produced
at
the
University
of
Arizona.
The
primary
investigators
associated
with
the
Dowd
et
al.
article
are
the
same
primary
investigators
associated
with
the
Rusin
et
al.
paper.
As
indicated
in
the
Dowd
et
al.
article,
the
model
used
would
tend
to
overestimate
actual
risk
and
represent
a
worst
case
scenario.
The
investigators
at
the
University
of
Arizona
have
continued
in
their
efforts
under
the
auspices
of
the
UA
National
Science
Foundation
Water
Quality
Center
(
see
"
http://
wqc.
arizona.
edu")
to
follow
up
on
their
earlier
modeling
efforts
with
studies
to
evaluate
bioaerosols
associated
with
landapplied
biosolids
under
various
field
conditions
found
across
the
country.

With
respect
to
the
last
paragraph,
please
see
the
EPA
response
to
EPA
Comment
Log
No.
51.

EPA
Log
#
25:
Northumberland
Association
for
Progressive
Stewardship
(
NAPS)
Sewage
Sludge
Study
Group
Comment
A.
Survey.
Lines
499­
553.
The
draft
response
states
that
a
comprehensive
survey
of
pollutants
"
is
not
likely
the
most
pragmatic
option
at
this
time,''
and
opts
out
for
"
a
more
targeted"
survey
"
to
fill
data
gaps."
We
predict
that
the:
"
data
gaps
"
are
huge
and
strongly
recommend
that
EPA
take
the
opportunity
"
at
this
time"
to
acquire
the
necessary
resources
to
conduct
the
NRC
recommended
comprehensive
survey.
This
is
critically
important
to
any
process
whereby
EPA
will
be
able
to
provide
the
information
needed
to
protect
public
health
(
and
the
environment­­
not
given
sufficient
focus
in
this
review
process).
We
also
caution
EPA
in
selecting
data
sources,
to
avoid
data
gathered
under
the
funding
and
influence
of
members
of
the
sludge
land
application
community.
In
collecting
only
independent
information,
we
think
you
will
reappraise
your
cavalier
attitude
toward
"
data
gaps."

Response
See
EPA
response
to
Comment
Log
No.
51.
EPA
will
evaluate
and
utilize
all
data
as
long
as
the
information
meets
EPA's
Data
Quality
Guidelines
irrespective
of
what
person
or
organization
generates
or
submits
the
information.

Environmental
Groups
EPA
Log
#
43:
Natural
Resources
Defense
Council
(
NRDC)

Comment
SURVEY
NRC
recommends
that
EPA
conduct
a
new
national
survey
of
chemicals
and
pathogens
in
biosolids
in
order
to
provide
feedback
for
updating
the
science
and
technology
of
biosolids
USEPA,
2003d
9
applied
to
land
and
to
identify
additional
toxic
pollutants
for
potential
regulation.
EPA
dismisses
NRC's
recommendation
for
a
new
national
survey,
instead
opting
for
a
more
"
targeted"
approach.
While
it
is
not
entirely
clear
what
EPA
means
by
a
"
targeted"
survey,
NRDC
urges
EPA
to
do
a
survey
comprehensive
enough
to
identify
the
full
range
of
toxins,
pathogens,
and
other
pollutants
in
sludge
and
to
determine
what
needs
to
be
done
to
control
such
pollutants
to
protect
human
health
and
the
environment.

Despite
acknowledging
the
value
of
updating
the
15
year­
old
data
from
the
1988
National
Sewage
Sludge
Survey
(
NSSS)
with
a
new
comprehensive
survey,
EPA
nonetheless
concludes
that
such
an
effort
would
be
impractical
because
many
of
the
same
constraints
facing
the
NSSS
­
such
as
inadequate
analytical
methods
and
limited
data
on
pollution
effects
and
means
of
exposure
­
continue
to
exist.
Failure
to
conduct
a
new
national
survey
bypasses
an
opportunity
to
apply
newly
developed
analytical
methods,
toxicological
data,
and
risk
assessment
methods
to
a
range
of
pollutants
that
are
likely
to
be
overlooked
by
EPA's
more
targeted
approach.
For
example,
improvements
have
been
made
in
the
areas
of
toxicogenomics,
improved
structure­
activity
relationships,
and
more
sophisticated
hazard
assessment
methodologies
such
as
the
human
toxicity
potential.
Of
significant
concern
is
EPA's
lack
of
specificity
regarding
what
chemicals
and
pathogens
will
be
the
subject
of
its
targeted
studies,
the
criteria
it
will
use
to
make
such
determinations,
and,
indeed,
whether
anything
more
than
pre­
existing
studies
will
be
done.

EPA
mentions
that
it
plans
to
continue
conducting
field
studies
to
provide
site­
specific
occurrence
data.
NRDC
agrees
that
such
studies
are
crucial
to
understanding
the
variances
in
pollutant
occurrence
across
different
geographical
regions,
envirormental
conditions,
and
application
methods.
However,
EPA
needs
to
ensure
that
these
site­
specific
studies
are
comprehensive
enough
to
form
the
basis
for
more
protective
regulations,
management
practices,
and
enforcement
nationwide.

EPA's
"
less
comprehensive,
more
targeted
survey"
involves
a
review
of
available
literature
from
States,
universities,
EPA
regional
offices,
and
the
general
public.
While
review
of
existing
studies
is
a
useful
first
step,
EPA
must
also
provide
leadership
in
coordinating
existing
research
across
the
country
and
spearheading
new
efforts
to
fill
gaps
where
issues
are
not
being
adequately
addressed.
EPA
is
the
most
suitable
organization
for
playing
such
a
leadership
role.
Mere
reliance
on
a
collection
of
uncoordinated
national,
regional,
and
local
literature
fails
to
provide
the
broad
perspective
necessary
for
adequately
reviewing
and
revamping
national
biosolids
regulations.

Finally,
EPA
is
considering
restudying
some
of
the
pollutants
originally
analyzed
in
the
1988
NSSS
as
well
as
"
some
new
and
emerging
chemicals"
according
to
cost
and
the
availability
of
analytical
methods.
NRDC
applauds
these
efforts
but
emphasizes
that
it
is
critical
for
EPA
to
follow
through
in
a
timely
manner
and
to
consider
the
full
range
of
emerging
chemicals,
including
the
odorants,
surfactants,
and
pharmaceuticals
specifically
mentioned
by
the
NRC.
Failure
to
do
so
will
bypass
an
opportunity
to
employ
the
latest
analytical
methods
to
determine
what
is
in
sludge
today.
Reliance
on
15­
year
old
flawed
data
and
information
from
the
NSSS
is
obviously
insufficient
to
meet
EPA's
statutory
obligations.
USEPA,
2003d
10
Response
Please
see
the
Summary
Response
and
EPA's
response
to
Comment
Log
No.
51.
EPA's
final
action
plan
describes
EPA's
approach
for
developing
new
information
through
internal
research
and
tracking,
evaluating,
and
coordinating
external
research
through
universities,
State
and
Federal
agencies,
trade
groups
and
private
organizations
among
others.

EPA
Log
#
43:
Natural
Resources
Defense
Council:
Comments
of
Dr.
Peter
L.
deFur
Data
on
chemicals
that
were
identified
in
1988­
89
The
1989
list
of
analytes
provided
on
the
EPA
web
site
showed
that
EPA
assessed
samples
and
screen
for
over
400
compounds
in
sewage
sludge
(
www.
epa.
gov/
edocket
docket
id
no.
OW­
2003­
0006;
document
no.
OW­
2003­
0006­
0022).
The
results
were
positive
for
more
than
200
of
these,
just
over
50%.

A
more
recent
list
of
chemicals
in
sewage
sludge
provided
by
Ellen
Harrison
(
Personal
Communication,
July
1,
2003)
shows
that
sewage
sludge
from
various
locations,
including
other
countries
contains
substantial
number
of
organic
chemicals
(
Table
1).
These
compounds
include
an
assortment
of
semi­
volatile
and
volatile
chemicals,
chlorinated
and
not,
pesticides
and
even
some
pharmaceutical
compounds.
The
categories
listed
by
Harrison
are
summarized
in
Table
2,
with
comments
on
the
toxic
effects,
and
environmental
properties,
and
if
the
chemicals
are
banned
in
the
US.
The
categories
of
PCBs,
dioxins,
furans
and
PAHs
dominate
the
total
number
of
individual
compounds
.
If
these
chemicals
are
considered
in
groups,
as
they
are
for
many
assessments
that
take
into
account
the
common
mechanisms
of
action,
then
other
chemicals
dominate
the
list.
These
other
chemicals
are
industrial
compounds
such
as
diphenylethers,
aliphatics,
chlorobenzenes
and
chlorinated
pesticides.

EPA
deleted
chemicals
from
consideration
in
the
503
rule
on
several
bases,
including
bans
on
manufacture
or
use,
non­
detection
or
detection
in
<
5%
of
samples
(
EPA,
1993)
in
the
1989survey
of
sewage
sludge.
These
criteria
are
no
longer
valid
for
excluding
chemicals
from
further
consideration,
according
to
recent
investigations
(
NRC,
2002;
Hale
and
LaGuardia,
2003).

Bans
on
manufacture
or
use
have
not
removed
many
of
the
most
persistent
and
bioaccumulative
toxic
compounds
from
the
environment,
foods,
or
the
U.
S.
population.
Several
banned
chemicals
are
found
in
sewage
sludge
and
yet
continue
to
present
problems
for
human
and
ecological
health,
including
PCBs,
DDT
and
metabolites,
chlordane,
dieldrin
(
and
related
pesticides
endrin
and
aldrin),
and
toxaphene
(
Table
1
and
EPA,
1993).
The
Centers
for
Disease
Control
and
Prevention
(
CDC)
in
2003
released
the
latest
results
of
the
national
survey
of
contaminants
in
human
tissues
(
CDC,
2003),
showing
continuing
human
body
burdens
of
DDT,
PCBs
and
the
metals
mercury
and
lead.
In
fact,
the
CDC
data
also
reveal
that
numerous
other
industrial
compounds
found
in
sludge
are
found
in
human
tissues
at
remarkably
high
levels.
Another
important
trend
in
the
CDC
data
is
the
distribution
of
the
tissue
levels
­
some
percentage
of
the
population
has
substantially
elevated
levels
of
these
compounds,
indicated
by
the
long
tail
of
the
upper
end
of
the
distribution
­
the
95th
percentile
still
leaves
5%
of
the
population
with
levels
higher
than
this
value.
USEPA,
2003d
11
The
more
recent
list
of
organic
compounds
found
in
sewage
sludge
(
Table
I)
prepared
by
Harrison
(
Pers.
Comm.,
July
2003)
contains
more
than
200
compounds
without
the
chlorinated
dibenzo­
dioxins
and
furans
(
of
which
there
are
75
and
135,
respectively).
Including
each
congeners
from
the
dioxins
and
furans
raises
the
total
number
of
organic
compounds
measured
in
sewage
sludge
to
more
than
400,
about
twice
the
number
that
EPA
detected
in
the
1989
sewage
sludge
survey.
Two
factors
account
for
the
discrepancy
between
recent
measurements
and
the
1989
survey,
according
to
both
NRC
(
2002)
and
Hale
and
LaGuardia
(
2002).
First,
the
analytical
detection
limits
were
variable,
ranging
many
orders
of
magnitude
for
the
eight
compounds
that
the
committee
selected
for
analysis.
Second,
the
analytical
methodologies
have
improved
significantly
in
the
past
14
years
since
EPA
conducted
the
last
sewage
sludge
survey.
As
a
result,
levels
in
sludge
that
were
once
at
or
below
the
limit
of
detection
(
see
NRC,
2002)
can
now
be
easily
measured.
A
number
of
these
levels
do
pose
risks
to
humans
and
to
wildlife.

Hale
and
coworkers
have
published
a
number
of
papers
on
their
research
on
the
chemicals
found
in
sewage
sludge
(
see
papers
by
Hale
and
LaGuardia
in
References).
Hale
and
LaGuardia
(
2003)
recently
reported
that
polybrominated
diphenyl
ethers,
nonylphenols
and
alkylphenols
are
abundant
in
sludges
and
that
the
pesticide
chlordane
is
present
at
high
concentrations.
Hale's
research
makes
several
important
points.
First,
the
older
work
failed
to
find
compounds
that
are
common
and
in
high
concentrations
(
chlordane),
as
noted
by
the
NRC
(
2002).
Second,
other
organic
compounds
that
are
common
and
in
high
levels
need
to
be
managed
and
reduced.
The
phenolics,
DPEs
and
PBBs
are
important
because
of
their
chemical
similarity
with
other
chemicals
known
to
present
hazards
to
health
and
the
environment
at
low
concentrations
(
e.
g.,
Jobling
et
al.,
1998).

As
noted
by
Hale
and
LaGuardia
(
2003)
for
sewage
sludge,
the
recent
literature
on
environmental
contaminants
is
replete
with
new
information
on
low
level
chemical
exposures
causing
alteration
of
normal
hormonal
function
in
humans
and
other
animals­­­
endocrine
disruption.
Numerous
sewage
sludge
contaminants
(
DDT,
DDD,
DDE,
BPA,
chlorobenzenes,
toxaphene,
nonylphenol,
dioxins,
furans,
PCBs,
PBBs)
are
known
endocrine
disruptors,
interfering
with
estrogenic,
androgenic
or
thyroid
systems
(
see
www.
ourstolenfuture.
orq
for
a
longer
and
more
complete
list
of
endocrine
disrupting1
chemicals).
These
same
compounds
are
also
active
in
other
animal
systems,
including
fish,
shrimp,
lobster,
crabs,
snakes
and
amphibians.
This
point
was
demonstrated
by
Rehman
et
al.
(
1999)
and
Jobling
et
al.
(
1998)
who
separately
reported
that
sewage
sludge
and
effluent,
respectively,
are
estrogenic.

EPA
dropped
from
further
consideration
all
the
chemicals
with
no
or
inadequate
toxicity
data.
The
summary
in
Table
2
indicates
that
a
large
number
now
have
toxicity
data
and
need
to
be
considered
in
the
rule.
Furthermore,
EPA
needs
to
assume
that
chemicals
with
little
or
no
toxicity
(
hazard)
information
will
have
properties
similar
to
those
of
the
most
similar
chemicals
for
which
there
are
data,
as
is
done
with
Arochlors.

The
EPA
data
and
more
recent
literature
data
on
concentrations
of
chemicals
in
sewage
sludge
(
Harrison
2003)
are
presented
with
EPA's
toxicity
data
from
the
IRIS
database
to
reveal
trends
and
patterns
(
Table
3).
The
data
in
Table
3
are
only
those
chemicals
found
on
both
EPA
and
USEPA,
2003d
12
Harrison
lists
of
chemicals
in
sludge
and
show
the
range
of
concentrations
from
Table
1,
given
on
a
dry
weight
basis,
with
the
toxicity
data
for
non
­
cancer
and
cancer,
and
the
chemical
identification
number
(
CASN).

The
range
of
chemical
concentrations
in
sludge
reported
in
the
available
literature
from
the
US
and
abroad
and
reported
by
EPA
spans
many
orders
of
magnitude
for
most
chemicals
on
the
list.
Equally
as
bothersome
is
the
fact
that
some
compounds
that
are
common
in
environmental
media
(
Hale
and
LaGuardia
2002)
were
detected
at
low
concentrations
or
not
at
all.
This
trend
supports
the
issue
raised
by
NRC
(
2002)
that
technological
advances
in
the
past
decade
have
made
the
older
data
from
1989
obsolete
or
nearly
so.

More
than
28%
of
the
chemicals
in
sludge
(
37/
128)
in
Table
3
have
no
toxicity
data
listed
in
IRIS,
indicating
the
magnitude
of
the
problem
that
remains
after
more
than
a
decade
of
EPA
regulations
on
sludge
use.
EPA
can
take
several
approaches
for
managing
and
regulating
these
compounds,
described
below.

Another
of
the
more
significant
trends
is
the
extent
to
which
chemical
concentrations
in
sludge
exceed
the
RfD
by
many
orders
of
magnitude.
When
the
RfD,
listed
on
a
per
kilogram
basis,
is
adjusted
for
an
individual
person
(
by
multiplying
the
RfD
by
weight),
say
70
kg
for
men,
as
EPA
does
for
regulations
and
standards,
the
levels
in
sludge
still
exceed
safe
levels
by
many
fold.
Even
if
a
person
is
exposed
to
only
a
small
fraction
of
the
chemical
from
sludge,
the
dose
may
still
exceed
"
safe"
levels,
as
in
the
case
of
DDT.

For
DDT,
the
maximum
concentration
reported
in
sludge
was
135
mg/
kg,
and
the
RfD
is
0.0005
mg/
kg/
day.
The
RfD
converts
to
a
daily
dose
of
0.035
mg/
day
for
a
70
kg
man;
this
amount
is
0.026%
of
the
amount
in
sludge
­
a
man
has
to
be
exposed
to
only
0.026%
of
the
DDT
in
sludge
to
exceed
the
"
safe"
dose.
Considering
that
DDT
(
and
metabolites
are
found
in
fish,
and
commonly
in
humans
(
see
CDC
website),
additional
exposures
are
a
certainty
and
the
dose
from
sludge
has
to
be
considered
a
fraction
of
the
total.
A
person
exposed
to
sludge
with
the
high
end
range
of
DDT
will
certainly
be
exposed
to
more
than
considered
"
safe".

A
similar
pattern
is
true
for
several
other
chemicals
as
described
for
DDT­
notably
chlordane
and
dieldrin.

Response
EPA
thanks
the
commenter
for
the
extensive
information
which
was
provided
on
the
occurrence
of
chemicals
in
sewage
sludge.
EPA
used
this
high
quality
information
in
identifying
chemicals
qualifying
for
further
exposure
and
hazard
analysis.
In
particular,
Table
1
and
references
provided
have
proved
extremely
useful
to
EPA.
The
pollutant
selection
process
is
described
in
Section
VIII
of
today's
FR
notice.
Details
of
the
various
steps
of
the
selection
process
and
accompanying
tables
are
provided
in
Appendix
O
of
the
Technical
Background
Document.

Municipal
Wastewater
Treatment
Plants
USEPA,
2003d
13
EPA
Log
#
14:
Metro
Wastewater
Reclamation
District
Comment
The
Metro
District
strongly
supports
EPA's
recommendation
to
begin
the
review
process
by
conducting
a
"
targeted
survey
"
to
determine
if
there
are
additional
pollutants
that
warrant
regulation.
In
making
those
determinations,
the
District
recommends
that
EPA
actively
seek
input
from
all
stakeholders,
including
academia,
state
and
federal
agencies,
the
environmental
community,
and
the
general
public.
Including
the
concerns
­
if
any
of
them
are
identified
­
of
ordinary
citizens
in
the
initial
stages
of
the
reevaluation
process
would
provide
assurance
that
no
critical
pollutants
are
overlooked.
In
deciding
whether
to
recommend
any
particular
pollutant
for
regulation,
when
it
can
be
shown
through
study
that
it
is
not
a
threat
to
human
health
or
the
environment,
then
that
pollutant
should
be
dropped
from
consideration.

Response
EPA
agrees
with
this
comment
and
will
seek
stakeholder
input
throughout
the
process
of
developing
and
evaluating
the
results
of
research
and
the
results
of
the
targeted
analytical
survey.

EPA
Log
#
47:
Miami­
Dade
County
Water
and
Sewer
Department
(
MDWASD)

Comment
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.

MDWASD
supports
EPA's
efforts
to
design
a
survey
to
help
fill
the
data
gaps
and
aid
in
future
studies.
As
previously
mentioned,
MDWASD
extends
its
facilities
and
staff
to
participate
and
assist
the
EPA
in
filling
the
data
gaps
dealing
with
biosolids.
We
also
emphasize
the
importance
of
stakeholder
participation
throughout
this
entire
process.

Response
See
the
response
to
Comment
Log
No.
14.
EPA
appreciates
the
analytical
data
on
sewage
sludge
that
we
have
received
from
several
wastewater
treatment
plants
over
the
years.

Unknown
EPA
Log
#
34:
Anonymous
Comment
Additional
discussion
regarding
a
new
national
sewage
sludge
survey.
The
EPA
concluded
a
new
and
comprehensive
survey
was
not
required.
The
EPA
references
analytical
limitations
for
many
pollutants,
with
out
any
additional
discussion.
This
answer
is
an
over
generalization.
A
proper
basis
to
this
conclusion
should
include
in
the
discussion
a
summary
of
pollutants
with
and
with
out
accepted
analytical
methods.
This
answer
raises
concern
that
the
EPA
is
overstating
the
severity
of
analytical
problems
with
pollutants
and
pathogens.
The
answer
also
raises
suspicion
that
the
EPA
does
not
want
to
raise
any
new
issues
that
will
further
complicate
the
risk
analysis.
A
comprehensive
survey
should
be
conducted,
and
the
data
collected
should
help
in
a
fair
and
impartial
evaluation
of
questionable
data.
USEPA,
2003d
14
Response
See
EPA
response
to
Comment
Log
No.
51.
A
significant
limitation
on
the
number
of
pollutants
that
can
be
surveyed
is
the
availability
of
adequate
analytical
methodologies
with
sufficient
precision,
accuracy,
detection
limits,
and
reliability.

Land
Application
Company
EPA
Log
#
26:
Synagro
Technologies,
Inc.

Comment
I.
CONDUCT
A
NEW
NATIONAL
SURVEY
OF
CHEMICALS
AND
PATHOGENS
IN
SEWAGE
SLUDGE
AND
BIOSOLIDS.

There
is
no
need
to
conduct
a
new
national
survey,
because
there
is
a
tremendous
amount
of
data
that
has
been
generated
on
biosolids
over
past
decade.
Analytical
results
for
the
Pretreatment
Program
under
40
CFR
Part
403
and
the
annual
reports
mandated
under
Part
503
have
supplied
an
updated,
comprehensive
database
which
used
current
methods.
Additionally,
there
have
been
surveys
conducted
independently
by
EPA
and
AMSA
relative
to
dioxin
and
radionuclides,
not
to
mention
the
research
work
conducted
by
the
Water
Environment
Research
Foundation
(
WERF)
and
the
National
Science
Foundation's
(
NSF)
only
Water
Quality
Center
(
WQC)
in
the
United
States
located
at
the
University
of
Arizona.
The
NAS/
NRC
Report
suffers
deficiencies
because
it
considered
only
a
small
fraction
of
the
available
information
in
the
published
and
unpublished
literature.
A
number
of
states
have
required
generators
(
POTWs)
to
test
and
report
sewage
sludge
and
biosolids
constituents.
These
data
may
provide
relevant
information.

EPA
should
consider
the
following
factors
and
not
engage
in
an
expensive
testing
campaign,
only
to
find
what
others
already
knew.

°
EPA
should
take
into
account
the
fact
that
most
new
chemicals
are
less
persistent,
bioaccumulative
or
toxic
than
older
chemicals.
For
example,
new
pesticides
are
designed
to
be
biodegradable
whereas
older
pesticides
were
designed
to
be
persistent.

°
Most
chemicals
in
biosolids
originate
with
consumer
products
that
have
been
approved
for
general
use
or
are
"
generally
recognized
as
safe".
Of
the
95
compounds
analyzed
for
in
wastewater
by
the
USGS,
the
overwhelming
majority
were
approved
pesticides,
pharmaceuticals,
and
components
of
personal
care
products
or
human
metabolites.
On
a
mass
basis,
the
most
prevalent
"
contaminants"
in
this
study
were
natural
human
steroids.

°
Data
presented
in
the
Report,
along
with
other
data
available
from
industry
shows
that
the
pre­
treatment
program
is
effective
at
removing
metals.
Since
metals
are
often
indicators
of
pollution
in
general,
these
results
also
suggest
that
metals
removal
from
effluent
via
pretreatment
is,
by
proxy,
effective
for
many
other
chemicals.

°
Many
compliance
reports
contain
substantially
more
chemical
data
than
concentrations
of
regulated
metals.
An
example
compliance
report
available
from
the
Orange
County
(
CA)
Sanitation
District
has
data
on
24
metals
or
elements,
5
non­
metallic
organics,
dioxins,
PCBs
USEPA,
2003d
15
(
mixtures
and
congeners),
60
individual
base­
neutral/
extractable
semi­
volatile
organics,
27
volatile
organic
compounds,
and
44
pesticides.
These
data
(
which
represent
biosolids
derived
from
about
400
MGD
of
wastewater
treatment)
lead
to
the
conclusion
that
contamination
of
biosolids
with
anthropogenic
pollutants
is
not
significant
for
t
his
utility.
EPA
should
compile
data
that
are
currently
available
from
compliance
reports
and
the
scientific
literature
and
then
limit
list
of
chemicals
to
those
with
verified
human
or
ecological
toxicity
data.
Once
these
data
are
compiled
data
gaps,
if
any,
may
be
filled
by
focused
surveys.

°
Other
large
regional
wastewater
treatment
plants
(
i.
e.,
Washington,
DC,
New
York,
Milwaukee,
Charlotte,
etc.)
can
give
a
good
picture
of
the
nation
by
region.

°
The
recent
national
survey
of
sewage
sludge
for
dioxins
and
dioxin­
like
compounds
provides
the
most
comprehensive
database,
representative
of
U.
S.
POTWs.
If,
as
EPA
has
maintained
for
the
last
decade,
dioxin
and
dioxin­
like
compounds
are
a
major
focal
point
of
their
concern
over
persistent,
bioaccumulative
toxic
(
PBT)
substances,
then
EPA
already
has
much
of
the
key
data
necessary
to
determine
potential
threats
to
human
health
and
the
environment
from
chemical
pollutants
in
sewage
sludge.

°
Before
the
Agency
expends
resources
to
conduct
a
national
sample
survey
involving
pathogens,
we
urge
consideration
of
the
following
screening
protocol
to
save
both
time
and
money.

o
EPA
should
first
clearly
identify
what
pathogens
are
of
concern,
and
whether
or
not
there
is
a
valid
analytical
test
available.
EPA
can
work
with
an
appropriate
professional
organization
such
as
the
Water
Environment
Federation
to
develop
a
protocol
for
testing
"
emerging
pathogens".
o
Next,
EPA
should
test
raw
sewage
sludge
samples
to
determine
if
the
pathogen
exists
in
the
untreated
matrix.
o
Next,
the
Agency
should
test
treated
sewage
sludge
(
biosolids),
including
Class
A
and
Class
B
biosolids
to
determine
if
the
pathogen
of
concern
survives
the
treatment
process,
and
in
what
concentrations
if
detectable.
o
The
step
above
­
investigating
pathogen
survival
in
treated
biosolids
­
should
also
be
intended
to
determine
if
the
fate
of
the
pathogen
of
concern
is
explained
by
correlation
with
indicator
organisms,
as
is
the
current
case
for
pathogens
of
concern.
o
EPA
should
consider
performing
some
testing
of
biosolids
amended
soils
for
pathogen
survival
rates
controlling
for
time
periods
specified
in
t
he
Part
503
regulations
for
land
use
restrictions.
This
information
could
address
the
premise
that
pathogens
are
destroyed
within
the
time
period
of
restricted
site
access.

The
NAS/
NRC
report
recommended
updating
exposure
assessment
concepts
for
the
reasonable
maximum
exposure
individual,
refined
fate
and
transport
models,
and
conducting
exposure
studies
for
preplanned
population
groups.
EPA
proposes
to
continue
some
existing
studies,
use
literature
to
focus
new
studies,
and
develop
a
plan
for
a
molecular
pathogen
tracking
study.
The
proposed
molecular
tracking
study
has
potential
pitfalls­
self­
identification
is
problematic,
because
there
needs
to
be
physician
verification
for
credibility
and
accountability.
Additionally,
there
are
no
existing
standardized
protocols
for
these
studies.
Furthermore,
all
sources
of
pathogens
need
to
USEPA,
2003d
16
be
identified­
not
only
biosolids.
However,
the
real
focus
needs
to
be
on
the
on­
going
studies
being
conducted
by
WERF,
the
NSF­
WQC,
and
USDA.

Response
EPA
is
aware
of
the
large
amount
of
information
that
is
in
the
open
literature
and
in
monitoring
reports
received
from
POTWs.
As
mentioned
before,
this
information
does
not
necessarily
meet
the
standards
for
providing
an
unbiased
national
estimate
of
sewage
sludge
quality
nor
does
this
information
necessarily
relate
to
pollutants
in
sewage
sludge
with
a
high
degree
of
hazard.
That
is
why
EPA
is
designing
and
executing
a
targeted
National
Sewage
Sludge
Survey
as
described
in
the
Summary
Response
and
in
a
previous
response
to
a
comment
in
this
section.

Association
EPA
Log
#
30:
Tri­
TAC
Comment
Survey
Tri­
TAC
strongly
supports
EPA's
plan
to
conduct
a
"
targeted
survey"
to
help
fill
data
gaps
and
inform
decisions
regarding
further
studies,
rather
than
conducting
a
comprehensive
national
survey.
In
designing
the
survey,
Tri­
TAC
recommends
that
EPA
actively
seek
input
from
all
stakeholders,
including
academia,
state
and
federal
agencies
and
POTWs.
Tri­
TAC
also
recommends
that
EPA
use
to
the
fullest
extent
existing
data
sources,
many
of
which
were
identified
in
the
Federal
Register
notice,
regarding
pollutant
occurrence
and
effects
when
designing
the
survey.
Tri­
TAC
agrees
with
EPA's
proposed
approach
to
examine
some
of
the
pollutants
that
were
studied
in
the
1988­
1989
National
Sewage
Sludge
Survey,
to
the
extent
that
resources
allow.
This
would
help
maintain
consistency
in
the
survey
data
and
analysis
and
provide
a
means
of
comparing
results
and
observing
trends.
New
chemicals
of
concern
should
be
included
to
the
extent
that
validated
analytical
procedures
exist
for
the
chemical,
the
chemical
is
likely
to
be
present
in
biosolids,
adequate
risk
criteria
are
available
to
conduct
risk
assessments,
and
Agency
screening
tools
indicate
a
significant
potential
for
risk.

Response
EPA
agrees
with
this
comment.

EPA
Log
#
50:
Water
Environment
Federation
(
WEF)

The
Water
Environment
Federation
(
WEF)
respectfully
submits
the
following
comments
on
the
above
referenced
Federal
Register
notice.
Founded
in
1928,
WEF
is
a
not­
for­
profit
technical
and
educational
organization
with
members
from
varied
disciplines
who
work
toward
the
WEF
vision
of
preservation
and
enhancement
of
the
global
water
environment.
The
WEF
network
includes
more
than
100,000
water
quality
professionals
from
79
Member
Associations
in
31
countries.
The
Federation
has
been
involved
in
activities
related
to
the
appropriate
management
and
use
or
disposal
of
municipal
sewage
solids
since
its
inception
in
1928.
USEPA,
2003d
17
Members
from
WEF's
Residuals
and
Biosolids
Committee,
Government
Affairs
Committee,
and
Public
Education
Committee
developed
the
following
comments.
These
individuals
are
from
both
the
private
and
public
sector
with
experience
in
the
management
and
beneficial
use
of
biosolids.

Comment
A.
Survey
WEF
endorses
the
effort
to
survey
new
chemical
categories,
such
as
odorants,
surfactants
and
pharmaceuticals,
to
provide
a
basis
for
subsequent
risk
assessment
efforts,
as
well
as
the
targeted
survey
approach.
For
some
parameters
(
emerging
pathogens,
for
example),
analytical
methods
are
not
well
developed.
To
perform
a
survey
on
the
scale
of
the
National
Sewage
Sludge
Survey
would
be
costly
and
perhaps
not
the
best
use
of
limited
funds.
WEF
acknowledges
EPA's
position
that
a
less
comprehensive,
more
targeted
survey
that
builds
on
the
lessons
learned
from
prior
surveys
will
minimize
the
expenditure
of
limited
resources.
If
EPA
believes
that
funding
will
limit
the
number
of
pollutants
surveyed,
WEF
recommends
that
stakeholder
input
be
obtained
to
help
finalize
the
list.

EPA
should
focus
limited
resources
on
research
that
addresses
the
constituents
of
most
concern
to
the
public.
It
is
important
to
insure
that
the
public
is
confident
that
EPA
is
responding
to
their
concerns
and
focusing
on
issues
that
confirm
the
safety
of
biosolids
products.
To
address
the
most
pressing
public
concerns,
odorants
and
other
emissions
and
pathogens
should
be
focus
areas.
With
respect
to
both
emerging
pathogens
and
odors,
data
currently
under
development
by
the
Water
Environment
Research
Foundation
(
WERF)
will
likely
be
of
use,
and
more
research
is
needed
in
both
areas.

EPA
should
also
consider
assessing
concentrations/
emissions
in
other
land
applied
products
such
as
manures
and
chemical
fertilizers
to
provide
some
comparison
and
context
for
biosolids
information
when
presented
to
the
public.
This
would
be
particularly
helpful
given
that
biosolids
are
land
applied
to
only
one
percent
of
agricultural
acreage
in
the
U.
S.
Including
other
materials
such
as
manures
and
other
fertilizers
may
not
necessarily
increase
survey
costs.
The
U.
S.
Department
of
Agriculture
has
a
comprehensive
pathogen
assessment
underway,
and
collaboration
with
USDA
would
reduce
costs
to
EPA
and
provide
the
public
with
a
greater
understanding
of
land
applied
amendments.

Response
EPA
agrees
with
these
comments.
One
of
the
research
projects
in
Section
VII
B
of
today's
Federal
Register
Notice
(
Project
10)
is
the
development
and
application
of
analytical
analytical
methods
for
detecting
pharmaceuticals
and
personal
care
product
in
sewage
sludge.
With
respect
to
the
last
paragraph
of
comments,
EPA
recognizes
the
importance
of
placing
sewage
sludge
in
context
with
other
waste
residuals
that
are
used
as
fertilizers
and
soil
amendments
such
as
animal
manures.
However,
section
405
(
d)
of
the
Clean
water
Act
restricts
EPA's
charge
to
sewage
sludge.
EPA
invites
outside
parties
to
collect
analogous
information
on
these
other
residuals
and
to
submit
this
information
to
EPA.

EPA
Log
#
46:
Association
of
Metropolitan
Sewerage
Agencies
(
AMSA)

Comment
Survey
USEPA,
2003d
18
AMSA
strongly
supports
EPA's
plan
to
conduct
a
"
targeted
survey"
to
help
fill
data
gaps
and
inform
decisions
regarding
further
studies,
rather
than
conducting
a
comprehensive
national
survey.
In
designing
the
survey,
AMSA
recommends
that
EPA
actively
seek
input
from
all
stakeholders,
including
academia,
state
and
federal
agencies
and
POTWs.
AMSA
also
recommends
that
the
Agency
use
to
the
fullest
extent
existing
data
sources,
many
of
which
were
identified
in
the
Federal
Register
notice,
regarding
pollutant
ccurrence
and
effects
when
designing
the
survey.
AMSA
agrees
with
EPA's
proposed
approach
to
examine
some
of
the
pollutants
that
were
studied
in
the
1988­
1989
National
Sewage
Sludge
Survey,
to
the
extent
that
resources
allow.
This
would
help
maintain
consistency
in
the
survey
data
and
analysis
and
provide
a
means
of
comparing
results
and
observing
trends.
New
chemicals
of
concern
should
be
included
to
the
extent
that
validated
analytical
procedures
exist
for
the
chemical,
adequate
risk
criteria
are
available
to
conduct
risk
assessments,
and
Agency
screening
tools
indicate
a
significant
potential
for
risk.

Response
EPA
agrees
with
these
comments.

States
EPA
Log
#
52:
Washington
State
Department
of
Ecology
Comment
The
Agency's
plan
to
begin
designing
a
survey
using
information
obtained
from
published
pollutant
occurrence
and
effects
data,
State
occurrence
data
basses,
and
input
received
during
the
public
comment
period.

I
agree
that
a
new
NSSS
lacks
necessary
pragmatism
and
support
the
idea
of
a
targeted
survey.
I
would
like
to
see
some
re­
visitation
of
the
1988
work,
perhaps
sampling
fewer
facilities
and
focusing
on
fewer
pollutants
of
concern.
I
believe
this
data
could
be
valuable
in
documenting
trends
or
variability
of
pollutants
at
facilities.
I
strongly
support
the
development
of
new
methods
or
validation
of
existing
methods
for
the
detection
of
pathogens
in
biosolids.
I
concur
that
we
have
a
specific
need
now
for
methods
of
evaluating
the
presence
of
pathogens
and
chemical
pollutants
in
bioaerosols.
At
the
same
an
appropriate
balance
should
be
maintained
so
that
bioaerosol
research
does
not
become
a
singular
or
overemphasized
focus
to
the
detriment
of
what
may
seem
more
mundane
but
which
nevertheless
continue
to
be
important
needs
in
this
area
(
e.
g.
use
of
Salmonella
sp.
in
testing
for
Class
A
determinations).

As
mentioned
earlier,
we
would
be
willing
to
make
our
data
available
to
EPA.
Our
experience
has
uncovered
a
number
of
shortcomings
which
we
continue
to
work
toward
overcoming.
Data
submitted
by
treatment
works
are
sometimes
summarized
as
opposed
to
or
in
addition
to
being
submitted
raw.
They
are
sometimes
transferred
from
lab
sheets.
In
both
cases
there
may
be
errors
or
different
assumptions
may
be
used
in
interpreting
the
data
(
the
common
question
for
example
of
how
to
treat
non­
detects).
Sometimes
reporting
errors
or
problems
with
application
of
methodologies
are
uncovered.
These
are
addressed
with
consideration
to
the
risk
posed
by
the
type
of
possible
reporting
error.
We
now
have
so
many
data
points
in
our
system
on
conventional
pollutants
that
at
least
on
a
statewide
programmatic
level
we
feel
comfortable
drawing
basic
USEPA,
2003d
19
conclusions
about
the
quality
of
biosolids
in
Washington
(
pollutants
are
much
lower
than
EPA's
Table
3)
regardless
of
some
presumed
level
of
error
in
the
data.
Where
an
individual
facility
is
in
question,
however,
we
still
go
back
to
the
hard
copy
for
review
and
verification
if
the
knowledge
is
critical.
In
short,
in
designing
a
survey
system
to
tap
existing
data
EPA
should
weigh
the
potential
shortcomings
of
any
existing
data
source
it
might
tap
against
the
value
of
what
would
be
obtained
by
a
fresh
data
gathering
effort.

In
its
response
EPA
mentions
the
Biosolids
Data
Management
System
and
the
revision
of
the
current
PCS
program.
The
URL
given
in
the
federal
register
is
incorrect,
but
the
BDMS
program
request
form
is
easily
located
by
an
Internet
search
at
the
University
of
Florida
TREEO
web
site.
My
state
opted
for
the
use
of
BDMS
some
years
back
and
presently
uses
a
version
earlier
that
the
one
now
available.
While
we
would
like
to
upgrade
we
have
been
advised
that
our
program
with
more
than
20,000
data
points
would
likely
encounter
data
transfer
problems
with
the
current
version
M.
Thus
we
are
left
waiting
on
the
Pro
Version,
delivery
date
unknown.
I
was
part
of
the
advisory
group
that
evaluated
the
upgrade
of
PCS
to
the
new
ISIS
system
and
the
incorporation
of
biosolids
data.
Frankly,
we
have
lost
touch
with
the
outcome
of
that
effort
at
this
point
but
expect
it
will
be
quite
some
time
before
a
new
federal
program
is
available.
I
remain
uncertain
as
to
its
suitability
for
our
purposes
though
we
would
support
data
exchange
between
BDMS
and
the
new
federal
system
to
the
best
of
our
ability.
I
hope
that
EPA
has
committed
the
necessary
resources
to
produce
the
new
version
of
BDMS
in
the
relatively
near
future.

Response
Please
see
the
EPA
response
to
Comment
Log
No.
51.
Project
3
in
Section
VII
B
of
today's
Federal
register
notice
describes
EPA's
project
to
develop
and
validate
a
suite
of
microbial
analytical
protocols
for
sewage
sludge.
EPA
recognizes
and
appreciates
Washington
State
DOE
for
offering
to
share
sewage
sludge
analytical
data
with
EPA.
Finally,
the
BDMS
system
has
not
yet
been
fully
implemented
due
to
a
lack
of
resources
and
some
incompatibility
with
the
Agency's
Performance
and
Compliance
System
(
PCS).

EPA
Log
#
45:
Florida
Department
of
Environmental
Protection
Comment
Comments
on
a
Targeted
Survey
We
generally
agree
with
the
EPA's
proposal
to
conduct
a
"
targeted"
survey.
However,
EPA
should
be
extremely
careful
with
the
development
of
what
will
be
"
targeted"
and
what
won't.
Existing
information
may
be
limited
or
of
substandard
value
depending
on
how
that
data
was
collected
and
compiled.
Additionally,
a
targeted
survey
may
be
criticized
if
pollutants
are
eliminated
from
consideration
based
on
assumptions
or
reasons
that
have
been
criticized
in
the
past.

Response
EPA
agrees
with
these
comments.
Please
see
the
EPA
response
to
Comment
Log
No.
51.

EPA
Log
#
48
and
39
(
duplicates):
Wisconsin
Department
of
Natural
Resources
USEPA,
2003d
20
Comment
4.
Section
VIII.
A.
Survey
1.
Summary
of
NRC
recommendations.
It
is
correctly
noted
that
the
report
recommended
surveying
a
suite
of
pathogens
in
both
raw
and
treated
sludge.
This
was
to
both
quantify
pathogens
present
in
sludge/
biosolids
and
also
to
verify
treatment
design
principles.
Likewise
verifying
the
effects
of
natural
attenuation
in
soil
over
time
and
risk
management
components
of
existing
regulations
was
recommended.
These
recommendations
are
stated
correctly
in
this
section
but
are
not
addressed
here.
See
comment
8,
16,
19
and
20.

5.
Section
VIII.
A.
Survey
2.
Available
data.
Is
the
cited
Region
8
study
adequately
funded
and
given
a
national
priority?

6.
Section
VIII.
A.
Survey
2.
Studies.
It
is
excellent
that
development
and
validation
of
analytical
methods
for
fecal
coliform
and
Salmonella
have
recently
been
worked
on
and
are
near
completion.
Will
funding
exist
to
also
do
this
for
the
other
regulated
pathogens;
helminth
ova
and
enteric
virus?
It
is
extremely
critical
that
this
be
done
(
Please
see
comment
7
and
11
also).
Will
speciation
of
mercury
and
arsenic
be
evaluated
in
sludge
as
was
recommended?

7.
Section
VIII.
A.
Survey
­
Planned
strategy
for
designing
a
targeted
survey.
1.
States
that
Method
Development
and/
or
validation
studies
for
enteric
virus
and
helminth
ova
will
be
performed.
Will
funding
be
provided
for
this?
This
work
is
critical
and
should
be
funded
(
see
also
comment
6
and
11).

IV.
The
following
comments
are
in
response
to
EPA's
plan
to
design
a
survey
scope
and
protocol
updating
the
1988­
1989
National
Sewage
Sludge
Survey
(
NSSS).

1.
In
addition
more
detail
is
needed
to
adequately
assess
the
Agency's
approach
to
designing
a
new
NSSS.
While
it
is
agreed
that
a
comprehensive
survey
may
not
be
cost
effective
for
a
large
suite
of
pollutants,
a
targeted
survey
is
appropriate.
The
survey
should
focus
on
pollutants
for
which
exposure
routes
and
toxicity
values
can
be
determined.
Existing
data
from
states
certainly
exists
for
the
regulated
pollutants
but
may
be
unreliable
for
pollutants
which
are
analyzed
less
frequently
and/
or
have
difficult
analytical
requirements.
Special
interest
should
be
given
to
emerging
pollutants,
and
especially
those
which
have
been
confirmed
to
be
present
in
biosolids
such
as
the
polybrominated
flame
retardants.

2.
The
Agency
response
appears
to
give
only
passing
interest
to
pathogens
or
indicator
organisms
not
currently
in
the
regulation.
Much
more
consideration
needs
to
be
given
to
the
NRC
recommendations
for
these
organisms.

Response
Please
see
the
response
for
Comment
Log
No.
51.
In
addition,
Project
3
in
Section
VII
B
of
today's
Federal
register
notice
describes
EPA's
project
to
develop,
optimize
and
validate
a
suite
of
microbial
analytical
protocols
for
sewage
sludge.
Project
4
in
Section
VII
B
in
today's
Federal
register
notice
describes
sewage
sludge
field
studies
that
will
develop
information
on
the
fate
of
pathogens
in
soils
from
the
land
application
of
sewage
sludge.

EPA
Log
#
59:
New
Jersey
Department
of
Environmental
Protection
USEPA,
2003d
21
Comment
EPA
requests
comments
on
its
plan
to
begin
designing
a
survey
using
information
obtained
from
published
pollutant
occurrence
and
effects
data,
State
occurrence
databases,
and
input
received
during
the
public
comment
period.

°
The
Department
agrees
with
the
approach
of
a
more
targeted
survey
to
help
fill
data
gaps.
To
this
end,
the
Department
can
offer
extensive
data
for
metals,
nutrients
and
125
priority
pollutants
required
to
be
reported
under
New
Jersey
regulations
for
all
treatment
works
that
generate
sewage
sludge.
The
Department
is
willing
to
discuss
making
this
data
available
to
the
EPA
in
a
format
that
would
be
most
beneficial.
In
addition,
as
part
of
its
continued
diligence
to
remain
at
the
forefront
on
scientific
issues,
the
Department
is
currently
involved
in
sampling
and
analysis
projects
for
radionuclides
(
currently
underway),
dioxins
and
PCBs
(
Request
for
Proposals
being
prepared),
and
mercury
speciation
(
Grant
award
notification
recently
received).
All
of
this
data
is
available
to
EPA
upon
request
or
completion.
The
Department
would
like
to
work
with
the
EPA
in
providing
this
data
in
a
meaningful
format
and
in
designing
sampling
and
analysis
protocols
for
projects
which
are
currently
being
initiated.

Response
EPA
agrees
with
these
comments.
Please
also
see
EPA's
response
to
Comment
Log
No.
51.
EPA
appreciates
NJDEP's
offer
to
share
analytical
data
with
EPA.

TOPIC
B.
EXPOSURE
Citizens
EPA
Log
#
29:
Henry
J.
Staudinger
Comment
B.
EPA's
Exposure
Measurement
Strategy
is
Not
Adequate.

NRC
Recommends
that
EPA
determine
the
reasonable
maximum
exposure
(
RME)
as
well
as
exposure
of
sensitive
groups
such
as
the
immune
compromised
in
order
to
undertake
meaningful
risk
assessment.

EPA
proposes
to
collect
and
review
published
literature,
Federal
and
state
databases,
the
NRC
report
and
other
sources
to
reassess
or
update
underlying
components
of
previously
conducted
risk
assessment.

Once
again
EPA
proposes
to
look
to
published
literature,
knowing
in
advance
that
the
prerequisite
independent
studies
have
not
yet
occurred.
Moreover,
exposure
evaluation
presumes
that
EPA
knows
the
pollutants
for
which
exposure
evaluations
are
needed.
As
discussed
earlier,
EPA
does
not
know
and
does
not
propose
to
find
out,
making
it
impossible
to
undertake
requisite
scientific
exposure
measurements.

Even
if
EPA
were
to
identify
those
pollutants,
the
Agency's
exposure
strategy
must
consider
the
complexity
of
biosolids
and
the
need
to
find
the
right
biosolids
for
each
pollutant
for
testing
if
a
serious
effort
is
made
to
determine
RME.
There
is
no
indication
that
EPA
proposes
to
do
so.
USEPA,
2003d
22
EPA's
reference
to
the
EPA/
USDA/
DEP
information
gathering
research
project
in
Pennsylvania
further
demonstrates
the
inadequacy
of
EPA's
strategy.
That
project
has
not
been
developed
to
address
NRC's
recommendations.
Its
focus
on
selected
constituents
in
selected
biosolids
under
site
specific
and
atmospheric
conditions
leaves
to
chance
the
ability
to
calculate
RME
for
each
of
the
many
different
constituents
that
may
be
present
in
specific
biosolids.

Response
Please
see
Section
VIII
of
today's
FR
notice:
EPA
based
its
hazard
screening
analysis
on
"
reasonable
maximum
exposure"
(
RME),
and
members
of
the
subpopulation
defined
as
subject
to
RME
included
children.
In
that
same
section,
EPA
identified
the
chemicals
that
will
undergo
exposure
screening.
In
Section
IX,
EPA
identified
those
chemicals
of
potential
health
and/
or
environmental
concerns
in
sewage
sludge,
and
a
targeted
survey
for
these
chemicals
will
be
conducted
to
obtain
more
refined
estimates
of
exposure.
In
addition,
as
indicated
in
Project
7
of
the
FR
notice
"
Conduct
Exposure
Measurement
Workshop",
EPA
will
conduct
a
workshop
to
identify
exposure­
related
research
priorities
among
methods
development,
ambient
measurements,
fate/
transport
modeling,
exposure
measurements,
including
identifying
the
specific
exposure
pathways
and
contaminants.
The
workshop
will
focus
on
exposure
measurement
tools
that
researchers
or
health
agencies
can
use
to
investigate
reports
of
adverse
human
health
effects
from
land
application
of
sewage
sludge.

EPA
Log
#
31:
David
L.
Lewis
Comment
Technical
errors
Synagro's
reasoning
based
on
outdated
science
and
technically
erroneous
concepts
includes
the
following
arguments:

°
Most
new
chemicals
in
wastewater,
such
as
pesticides,
can
be
dismissed
outright
as
presenting
negligible
risks
because
they
are
readily
biodegradable
This
assertion
assumes
that
biodegradation
products
are
less
harmful
to
public
health
and
the
environment
than
the
parent
compounds.
In
fact,
breakdown
products
of
pesticides
and
other
chemicals
are
often
more
persistent
and
more
toxic
than
their
parent
compounds.
For
example,
malathion
monoacid,
a
biodegradation
product
of
malathion,
is
ten
times
more
toxic
to
fish
than
malathion.
Hence,
biodegradation
of
this
pesticide
at
waste
treatment
plants
would
increase,
not
decrease,
its
toxicity.

Similarly,
in
our
research
on
enantioselective
biodegradation
(
Lewis,
DL,
et
al.
1999.
Nature.
401:
898­
901),
we
point
out
that
biodegradation
mediated
by
microorganisms
in
sewage
sludge
can
enhance
the
persistence
and
toxicity
of
pesticides,
pharmaceuticals,
and
other
industrial
chemicals
exhibiting
chirality.

°
Pathogen
analyses
are
not
as
reliable
as
chemical
analyses
for
determining
detection
limits,
species
identification,
QA/
QC,
and
background
levels
USEPA,
2003d
23
Recent
advances
with
DNA
sequencing
and
in­
situ
PCR
techniques
now
allow
microbial
ecologists
to
detect
and
accurately
identify
even
a
few
copies
(
molecules)
of
DNA.
In­
situ
PCR
techniques
permit
ecologists
to
visualize
even
a
single
organism
of
a
single
genotype
in
soil
or
water
without
culturing
it.
They
can
not
only
tell
whether
it
possesses
a
particular
DNA
or
RNA
sequence
(
which
can
establish
beyond
any
reasonable
doubt
its
genus
and
species),
but
whether
specific
genes,
including
those
for
pathogenicity
factors,
are
turned
on.
It
is
now
possible,
therefore,
not
only
to
tell
whether
a
single
organism
is
present,
but
whether
it
is
living
and
carrying
out
specific
metabolic
functions.

A
decade
ago,
when
most
microbiologists
were
plating
bacteria
with
nutrient
agar
and
using
biochemical
tests
for
identification,
analytical
chemistry
was
greatly
advanced
over
microbiology.
Nowadays,
chemists
still
do
not
have
any
reliable
analytical
methods
for
most
chemical
pollutants.
But,
since
all
microorganisms
have
DNA
or
RNA,
microbiologists
can
develop
specific
probes
to
detect
even
a
few
copies
of
the
genetic
markers
characteristic
of
any
species
or
strain.
Current
genetic
techniques,
in
many
ways,
place
microbiologists
ahead
of
analytical
chemists.

°
503
requires
2­
log
reduction
(
99%);
therefore,
pathogens
in
biosolids
cannot
present
any
significant
risk
of
infection
Risk
of
infection
depends
on,
among
other
things,
the
size
of
inoculum.
If,
for
example,
a
number
of
soil
particles
containing
a
certain
pathogen
found
an
appropriate
portal
of
entry
(
e.
g.,
through
an
abrasion,
sunburned
skin,
inhalation,
or
ingestion),
and
it
were
to
take
1,000
infectious
units
to
cause
infection,
then
the
infection
risk
is
insignificant
if
10,000
infectious
units
on
the
particles
were
reduced
by
99%.
If,
however,
the
same
particles
harbored
100,000
or
more
infectious
units
and
underwent
a
99%
reduction
in
numbers,
the
risk
of
infection
would
be
high.

°
Added
water
retention
provided
by
organic
matter
in
biosolids
protects
the
quality
of
surface
water
and
groundwater
While
organic
matter
in
sludge
can
bind
certain
metals
and
hydrophobic
organic
molecules
under
certain
conditions,
it
will
not
retain
many
hydrophillic
pollutants.
Not
surprisingly,
therefore,
groundwater
contamination
from
nitrates
and
other
water
soluble
components
leaching
from
sewage
sludge
has
been
observed
at
land
application
sites
across
the
United
States
by
regional
EPA
offices.
Rather
than
promoting
processed
sewage
sludge
as
a
panacea
with
no
down
sides
whatsover,
the
industry
needs
to
acknowledge
the
limitations
of
this
practice
along
with
its
potential
merits
when
adequately
processed
and
properly
applied.

The
Shiffman
et
al
article
Synagro
argues
that
the
Shiffman
reference
(
Shiffman
et
al.
J.
Agromedicine
Vol.
7(
1)
2000)
"
does
not
deal
with
municipal
biosolids
and
therefore
is
not
a
relevant
reference
for
biosolids."
This
reference,
which
is
co­
authored
by
John
Walker
of
the
EPA,
is
rather
gently
dismissed
by
Synagro
as
simply
irrelevant.
[
If
only
my
expert
reports
in
the
Marshall
case
and
our
publications
in
peer­
reviewed
journals,
which
came
to
exactly
the
same
conclusions
as
Shiffman
and
coauthors,
were
treated
with
such
respect
and
kindness.]
USEPA,
2003d
24
Contrary
to
Synargo's
conclusion,
Shiffman
et
al
did
address
at
length
the
potential
adverse
health
effects
of
contaminants
(
inorganic
and
organic
chemicals
as
well
as
biological
and
microbiological
components)
in
recycled
biosolids.
Biosolids,
invariably,
were
mentioned
along
with
animal
wastes
in
all
of
their
overall
analyses
and
conclusions.
To
demonstrate
this,
I
have
reproduced
most
of
the
statements
on
manures
in
their
Executive
Summary
(
below),
showing
that
the
same
conclusions
were
applied
by
the
authors
equally
to
municipal
biosolids.

Schiffman's
abstract,
which
also
gives
a
useful
summary,
begins:
Complaints
of
health
symptoms
from
ambient
odors
have
become
more
frequent
in
communities
with
confined
animal
facilities,
wastewater
treatment
plants,
and
biosolids
recycling
operations.
The
most
frequently
reported
health
complaints
include
eye,
nose,
and
throat
irritation,
headache,
nausea,
diarrehea,
hoarseness,
sore
throat,
cough,
chest
tightness,
nasal
congestion,
palpitations,
shortness
of
breath,
stress,
drowsiness,
and
alterations
in
mood.

Excerpts
from
Shiffman
et
al
Executive
Summary
(
Underlining
added
for
emphasis)
This
report
summarizes
(
the)
current
state
of
knowledge
regarding
the
health
effects
of
ambient
odors
with
special
emphasis
on
odorous
emissions
from
animal
manures
and
other
biosolids.

By
the
review
of
these
studies,
examples
are
given
that
can
help
elucidate
the
types
of
health
symptoms
that
may
occur
from
exposure
to
odorous
volatile
compounds
and
associated
particulates
from
animal
feeding
and
the
processing
and
recycling
of
animal
manures
and
biosolids.

Odorous
airborne
emissions
from
confined
animal
housing,
composting
facilities,
and
land
application
of
sludge
can
contain
other
components
that
may
be
the
cause
of
the
symptoms
such
as
bioaerosols
consisting
of
endotoxin,
dust
from
food,
airborne
manure
particulates,
glucans,
allergens,
microorganisms,
or
toxins.

The
odorous
emissions
that
reach
neighbors
of
animal
and
municipal
wastewater
facilities
and
recycling
operations
are
a
function
of
the
concentration
of
volatiles
produced
at
the
source
as
well
as
their
emission
rates,
dispersion,
deposition,
and
degradation
in
the
downwind
plume."

Special
emphasis
was
placed
on
potential
health
issues
related
to
odorous
emissions
from
animal
manures
and
other
biosolids.

Workshop
participants
concluded
that
current
evidence
suggests
that
the
symptom
complaints
experienced
by
neighbors
of
some
odorous
animal
operations
and
municipal
wastewater
facilities
may
constitute
health
effects.

Most
odorants
associated
with
animal
manures
and
biosolids
are
volatile
organic
compounds
(
VOCs)
that
are
generated
by
bacterial
degradation
of
protein,
fat,
and
carbohydrates
in
the
organic
matter.
Reactive
inorganic
gases
such
as
ammonia
and
hydrogen
sulfide
are
also
important
odorants
that
can
be
emitted
from
animal
manures
and
biosolids.
USEPA,
2003d
25
When
odors
from
manures
and
biosolids
rise
to
the
level
that
complaints
are
produced,
many
of
these
complaints
are
focused
on
the
unpleasant
nature
of
the
odor
rather
than
on
health
symptoms.
However,
health
symptoms
have
been
reported
with
increasing
frequency
to
low
levels
of
odor
from
manures
and
biosolids.

Workshop
participants
discussed
three
paradigms
by
which
ambient
odors
may
produce
health
symptoms
in
communities
with
odorous
manures
and
biosolids.

While
the
concentration
of
each
individual
compound
identified
in
odorous
air
from
agricultural
and
municipal
wastewater
facilities
seldom
exceeds
the
concentration
that
is
known
to
cause
irritation,
the
combined
load
of
the
mixture
of
odorants
can
exceed
the
irritation
threshold.
That
is,
the
irritation
induced
by
the
mixture
of
odorants
derives
from
the
addition
(
and
sometimes
synergism)
of
individual
component
VOCs.

Response
EPA
thanks
the
commenter
for
the
views
and
information
provided.
Please
see
EPA's
response
to
Comment
Log
No.
29.
EPA
also
recognizes
the
value
of
the
Schiffman
Symposium
and
resulting
paper
to
identify
odorants
as
a
potential
source
of
human
health
impacts
from
the
land
application
of
sewage
sludge.
Project
4
"
Field
Studies
of
Application
of
Treated
Sewage
Sludge"
in
Section
VII
B
of
today's
Federal
register
Notice
describes
the
field
studies
that
will
investigate
these
volatile
compounds.
These
studies
will
be
a
first
step
toward
understanding
the
nature
of
these
emissions
and
developing
strategies
to
mitigate
them.

EPA
Log
#
37:
David
A.
Burrows
Comment
The
NCR
committee
"
found
that
some
potential
exposure
pathways
were
not
sufficiently
considered
when
the
use
of
restrictions
were
developed.
For
example,
potential
off­
site
inhalation
of
dust
and
aerosols
does
not
appear
to
have
been
considered"
(
page
304
NRC
report).
The
committee
also
stated:
"
EPA
also
did
not
address
sufficiently
the
potential
for
surface­
water
contamination
by
runoff,
ground
water
contamination,
and
secondary
transmission
of
diseases."
(
page
14
NRC
Report).
The
NRC
also
noted:
"
No
risk
assessments
were
conducted
to
establish
the
1993
pathogen
standards
or
Class
B
sewage
sludge"
(
NRC
report
page
13).
Peer
reviewed
research
studies
are
needed
to
determine
whether
or
not
Class
B
sewage
sludge
site
restrictions
are
truly
protective.

Response
Please
see
EPA's
response
to
Comment
Log
No.
29.

EPA
Log
#
40:
Thomas
F.
Albert
Comment
#
18:
On
page
17386
the
"
Exposure
research"
section
(
3
paragraphs)
presents
information
(
some
not
accurate)
regarding
the
cooperative
sludge
study
to
be
done
at
5
sites
in
Pennsylvania
starting
in
2003.
This
is
a
cooperative
effort
of
EPA,
USDA,
and
PA
Dept.
Environmental
Protection.
I
am
a
member
of
the
study's
Information
Sharing
Group
(
ISP)
and
am
painfully
aware
of
many
of
the
limitations
of
the
PA
study.
The
brief
description
presented
here
by
EPA
presents
the
study
in
a
rather
grandiose
manner
and
makes
no
mention
of
its
USEPA,
2003d
26
limitations.
For
example
there
was
NO
PEER
REVIEW
of
the
study
design,
there
was
no
discussion
in
the
project
outline
regarding
conflicts
of
interest
(
agencies
that
are
proponents
of
sludge
use
doing
impact
related
studies),
the
sample
sizes
in
most
instances
are
small
and
will
only
be
able
to
detect
major
differences
between
control
and
experimental,
the
study
is
surely
a
LOW
POWER
study.
When
the
comments
are
finalized
by
EPA,
it
is
important
that
EPA
present
the
PA
study
in
its
true
light
and
not
overstate
it.
Not
the
least
of
the
problems
is
that
it
seems
there
will
be
no
bioaerosol
sampling
after
sludge
application
(
this
conflicts
with
what
EPA
reports
on
page
17386).

Comment
#
19:
On
page
17386
in
the
10
line
section"
Planned
Exposure
Activities"
EPA
again
mentions
the
PA/
USDA/
PA
study.
EPA
mentions
that
it
will
"
study
an
additional
five
field
application
sites."
Does
this
mean
that
AFTER
the
present
cooperative
study
of
5
sites
that
there
will
be
a
cooperative
effort
(
PA/
USDA/
PA)
to
examine
a
second
set
of
5
sludge
sites?
In
this
section
EPA
implies,
that
a
"
molecular
pathogen
tracking
exposure
study"
will
be
done
to
determine
if
sick
people
near
a
sludge
site
are
infected
with
organisms
derived
form
the
sludge.
If
this
is
what
is
proposed,
this
is
great.
Why
doesn't
EPA
do
this
NOW?
There
is
no
need
to
wait.
EPA
and
PA
DEP
know
of
sites
NOW
where
people
near
sludge
fields
complain
of
sickness,
why
isn't
work
started
NOW?

Response
Please
see
the
EPA
response
to
Log
Comment
No.
29.
In
addition,
EPA
will
initiate
sewage
sludge
field
studies
to
measure
microbial,
chemical,
and
particulate
emissions
from
sewage
sludge
land
application
sites
(
Project
4
in
Section
VII
B
of
today's
Federal
Register
notice).
These
studies
will
be
a
first
step
toward
understanding
the
nature
of
the
emissions
from
these
sites
and
developing
strategies
to
mitigate
them.

EPA
expects
that
this
project
will
eventually
lead
to
the
reduction
of
potential
risk
factors
by
evaluating
the
effectiveness
of
methods
for
treating
and
managing
sewage
sludge
on
the
land
and
helping
to
determine
if
amendments
and/
or
additions
to
the
Part
503
Standards
are
warranted
to
enhance
public
health
protection.
As
explained
in
the
Agency's
preliminary
strategy
published
in
April
2003,
EPA
planned
to
conduct
a
study
in
Pennsylvania
in
cooperation
with
USDA,
the
State
of
Pennsylvania,
and
stakeholders,
including
citizens
and
citizen
groups
that
have
expressed
concerns
about
the
land
application
of
sewage
sludge.
EPA
plans
to
work
with
State,
Regional,
USDA,
and
other
partners
to
conduct
field
studies
of
land
application
practices
at
up
to
five
sewage
sludge
land
application
sites.
Field
sampling
at
actual
application
sites
will
involve
a
variety
of
media
and
methods
to
characterize
airborne
and
soil­
bound
contaminants
resulting
from
land
application
of
sewage
sludge.
Depending
on
resources,
items
that
will
be
investigated
include,
but
are
not
limited
to:
(
1)
quantification
of
aerosol
components
such
as
pathogens,
endotoxins,
particulate
matter,
odor
compounds,
and
volatile
organic
compounds
(
VOCs);
2)
quantification
of
sewage
sludge
components
such
as
pathogens
and
metals,
and
3)
effects
of
these
components
on
the
soil
to
which
the
sewage
sludge
is
applied.
Quality
Assurance
(
QA)
and
specific
research
plans
are
being
developed.
EPA
plans
to
initiate
peer
review
on
this
research
plan
in
2004
and
field
work
will
not
begin
until
the
plan
has
been
peer
reviewed.
The
Agency
plans
to
complete
the
study
and
draft
a
report
two
years
after
the
QA
plan
has
been
approved.
USEPA,
2003d
27
EPA
Log
#
25:
Northumberland
Association
for
Progressive
Stewardship
(
NAPS)
Sewage
Sludge
Study
Group
Comment
B.
Exposure
Lines
564­
630.
EPA's
approach
of
evaluating
"
available
exposure
information"
may
prove
to
be
futile,
since,
up
until
now,
the
levels
of
chemicals,
pathogens,
viruses,
pharmaceuticals
and
other
harmful
ingredients
contained
in
sewage
sludge
have
largely
been
unknown
to
the
scientific
and
medical
communities.
Perhaps
this
phase
should
be
postponed
until
the
comprehensive
survey
we
recommended
above
is
completed
and
more
comprehensive
exposure
experience
may
be
gathered
and
evaluated.

Response
Please
see
the
EPA
response
to
Comment
Log
No.
51
in
the
Survey
Section
of
this
document.

EPA
Log
#
56:
Don
H.
Berkebile
Comment
I
enclose
the
latest
test
result
of
my
water
supply,
taken
since
the
spreading
of
biosolids.
These
two
tests
were
not
taken
at
the
source,
but
in
the
house,
after
going
through
the
ultraviolet
system.
After
the
earlier
test
I
replaced
both
the
bulb
and
the
filter.
You
will
readily
see
that
the
coliform
went
from
more
than
28.8
to
over
200.5,
and
the
E.
coli
went
from
a
barely
acceptable
1
to
32.4.
This
water
is
now
not
fit
to
use.
I
need
to
explain
that
the
200.5,
with
an
arrow
pointing
toward
it
indicates
that
200.5
is
this
laboratory's
maximum
capability
because
of
their
methods
and/
or
equipment,
so
the
reading
would
be
above
that,
perhaps
only
210,
but
also
perhaps
400.

This
particular
piece
of
ground
is
entirely
unsuited
to
this
practice,
and
I
urge
again
that
EPA
use
this
farm
for
one
of
the
five
study
sites
in
PA.

Response
Please
see
the
EPA
response
to
Comment
Log
No.
40.
Please
contact
Dr.
Patricia
Millner
at
301­
504­
8163
millnerp@
ba.
ars.
usda.
gov
,
the
USDA
team
leader
for
these
studies
to
discuss
the
eligibility
for
your
site
in
these
studies.

Environmental
Groups
EPA
Log
#
7:
Sierra
Club
Comment
In
Augusta,
Georgia,
local
veterinarians
found
that
pathogens,
heavy
metals
,
and
other
pollutants
in
land­
applied
sewage
sludges
caused
liver
and
kidney
damage
to
dairy
cows
at
two
farms.
The
Georgia
Environmental
Protection
Division
(
EPD)
investigated
and
confirmed
that
the
Augusta
waste
treatment
facility
allows
toxic
levels
of
these
contaminants
to
concentrate
in
sludges
.
Biochemists,
toxicologists
and
other
experts
concluded
that
contaminants
in
the
Augusta
sludges
caused
high
rates
of
morbidity
and
mortality
in
dairy
herds
and
loss
of
milk
production
at
the
farms
.
Soils
at
both
farms
are
so
contaminated
now
that
they
will
require
extensive
remediation
before
crops
could
be
grown
for
human
consumption
or
animal
feed.
USEPA,
2003d
28
EPA
Response:
EPA
has
gathered
information
on
the
Georgia
case.
EPA
has
found
no
evidence
that
exposure
to
land­
applied
sewage
sludge
was
the
cause
of
any
of
the
allegations
of
animal
deaths
cited.

EPA
Log
#
43:
Natural
Resources
Defense
Council
(
NRDC)

Comment
EXPOSURE
NRC
recommends
that
EPA
use
current
exposure
information
and
updated
conceptual
exposure
models
to
update
and
strengthen
the
scientific
basis
of
the
chemical
and
pathogen
standards.
EPA's
response
includes
commitments
"
to
determine
if
new
exposure
and
risk
calculations
may
be
warranted"
and
to
review
currently
available
exposure
information.
Although
both
of
these
commitments
are
generally
beneficial,
they
are
merely
first
steps
towards
updating
the
scientific
basis
of
the
sewage
sludge
regulations,
as
NRC
recommends.
EPA
also
indicates
that
it
intends
to
review
whether
its
exposure
analysis
for
metals
in
Round
1
rulemaking
was
too
conservative.
Given
the
resource
limitations
that
are
referenced
throughout
the
federal
register
notice,
the
fact
that
only
a
handful
of
the
thousands
of
compounds
found
in
sludge
that
are
potentially
harmful
to
human
health
or
the
environment
are
currently
regulated,
the
Agency's
failure
to
consider
the
additive
and
synergistic
effects
of
even
those
few
pollutants
that
are
regulated,
and
given
the
documented
woefully
inadequate
enforcement
of
the
existing
program,
NRDC
would
urge
EPA
to
defer
devoting
its
scarce
resources
to
follow
up
on
this
issue
until
after
it
has
met
its
statutory
obligation
to
ensure
that
sludge
is
adequately
regulated
to
protect
human
health
and
the
environment
and
that
those
adequate
regulations
are
being
adhered
to
consistently
by
the
sludge
industry
across
the
country.

EPA's
current
exposure
research
appears
productive,
but
more
needs
to
be
done.
EPA's
primary
biosolids
exposure
research
project
is
a
joint
field
study
with
the
U.
S.
Department
of
Agriculture
and
the
Pennsylvania
Department
of
Environmental
Protection
("
EPA/
USDA/
PA
Study")
designed
to
gather
site­
specific
information
on
current
practices
and
to
identify
and
evaluate
the
fate
of
pollutants
following
biosolids
This
project
will
provide
useful,
but
limited,
data
regarding
aerosol
and
land
exposure
from
a
narrow
sampling
of
land
application
sites.
Despite
its
clear
value,
this
single
study
seems
to
comprise
the
vast
majority,
if
not
all,
of
the
research
currently
being
done
by
EPA
related
to
exposure.
Moreover,
according
to
the
Project's
Draft
Quality
Assurance
Project
Plan,
"
it
will
not
be
possible
to
draw
general
conclusions
from
this
data."

A
limitation
of
the
EPA/
USDA/
PA
study
is
that
none
of
the
five
sites
chosen
have
ever
been
associated
with
claims
of
disease
or
other
public
health
effects
related
to
biosolids
exposure.
EPA
clearly
acknowledges
as
much:
"
this
study
is
not
a
health
effects
study
and
thus
does
not
address
those
NRC
recommendations."
Unfortunately,
EPA's
unwillingness
to
conduct
an
epidemiological
study
falls
far
short
of
NRC's
recommended
course
of
action
and
what
is
required
to
fully
assess
any
causality
between
biosolids
exposure
and
health
effects.
EPA
states
that
it
is
"
exploring
a
plan
to
conduct
a
pathogen
tracking
exposure
study"
with
USDA
and
the
State
of
PA.
The
parameters
of
this
potential
study,
as
briefly
described
in
EPA's
comment,
may
provide
information
that
would
be
useful
for
determining
the
health
effects
of
biosolids
exposure;
however,
it
should
be
used
in
conjunction
with
other
means
of
assessing
exposure,
such
as
USEPA,
2003d
29
measuring
contamination
levels
for
food
grown
on
sludge,
drinking
water
sources
hydrologically
connected
to
land
application
sites,
and
soil
on
yards
to
which
sludge
has
been
applied.
For
all
of
these
exposure
studies,
EPA
must
also
move
from
the
exploration
phase
to
the
planning
and
execution
stage
so
that
this
important
exposure
information
can
be
gathered
and
used
to
inform
policy
decisions.

Response
Please
see
EPA's
responses
to
Comment
Log
Nos.
29
and
40.
EPA
has
reconsidered
its
position
on
reevaluating
the
exposure
analysis
that
it
performed
as
the
technical
basis
for
the
Part
503
Round
One
Standards.
However,
under
Project
13
"
Review
Criteria
for
Molybdenum
in
Land­
applied
Treated
Sewage
Sludge",
EPA
intends
to
assess
the
need
and
appropriate
level
for
a
numerical
standard
for
molybdenum
in
sewage
sludge
using
the
results
and
conclusions
of
a
workshop
held
in
2000
and
supplemented
with
additional
data
developed
since
2000.
EPA
expects
to
complete
this
assessment
in
2005.
EPA
notes
that
the
Office
of
Research
and
Development
is
reassessing
the
human
health
benchmarks
in
the
Integrated
Risk
Information
System
(
IRIS)
for
arsenic,
cadmium,
copper,
nickel
and
selenium.
Once
these
reassessments
are
completed,
the
Agency
will
determine
whether
there
is
a
need
to
reevaluate
the
numerical
standards
for
Round
One
metals
in
sewage
sludge.

In
addition,
EPA
used
the
same
probabilistic
model
to
evaluate
the
chemicals
cited
in
today's
notice
in
response
to
section
405(
d)(
2)(
C)
that
was
used
to
determine
human
health
risk
from
exposure
to
dioxins
in
land­
applied
sewage
sludge
in
the
Round
Two
rulemaking.

Association
EPA
Log
#
30:
Tri­
TAC
Comment
Exposure
Tri­
TAC
supports
the
EPA's
plans
to
collect
and
review
currently
available
exposure
information
from
published
literature,
federal
and
state
databases,
the
NRC
Report,
and
other
relevant
sources
to
identify
data
gaps
and
its
plans
to
use
a
risk
assessment
framework
to
evaluate
priorities
for
reassessing
or
updating
underlying
components
including
exposure
assumptions
of
previously
conducted
risk
assessments.
Tri­
TAC
also
supports,
to
the
extent
resources
permit,
reviewing
exposure
information
used
in
the
Round
1
and
Round
2
rules
in
light
of
new
exposure
information
and
updating
that
exposure
information
as
appropriate.
Tri­
TAC
cautions
EPA
to
employ
a
consistent
approach
in
identifying
and
determining
exposure
pathways
for
ongoing
and
new
studies.

Response
Please
see
EPA
responses
for
Comment
Log
Nos.
29,
40,
and
43.

EPA
Log
#
50:
Water
Environment
Federation
(
WEF)

Comment
B.
Exposure
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
chemical
and
USEPA,
2003d
30
technology­
based
pathogen
standards.
This
category
also
includes
recommendations
to
evaluate
exposure
for
the
"
reasonable
maximum
exposure
(
RME)
individual".

In
the
strategy,
EPA
states
that
understanding
human
exposure
is
key
for
risk
assessments
supporting
the
Part
503
Rule
and
that
the
Agency
plans
to
use
a
risk
assessment
framework
to
evaluate
the
priorities
for
reassessing
or
updating
the
underlying
components
(
including
exposure
assumptions)
of
previously
conducted
risk
assessments.
EPA
will
use
this
information
to
determine
if
new
exposure
and
risk
calculations
may
be
warranted
for
pollutants
not
previously
assessed.
WEF
supports
the
reassessment
of
exposure
and
risk
calculations
for
previously
evaluated
pollutants
if
new
data
or
practices
indicate
that
past
assessments
may
no
longer
protect
human
health
or
if
there
are
continued
concerns
raised
by
the
public.

WEF
supports
EPA's
approach
to
exposure
research,
especially
the
Pennsylvania
study
referenced.
WEF
supports
EPA's
ongoing
exposure
research
in
partnership
with
USDA
and
the
State
of
Pennsylvania
that
will
evaluate
a
number
of
issues
related
to
land
application
of
biosolids,
including
occurrence
of
pathogens,
chemicals,
and
bioaerosols.
WEF
also
supports
the
Agency's
research
on
microorganisms
and
chemicals
at
animal
manure
application
sites
and
composting
sites.
Any
additional
research
should
also
include
the
formation
of
an
Information
Sharing
Group
of
various
stakeholders
to
insure
the
final
product
answers
questions
that
are
key
to
the
public.
Stakeholder
input
has
been
a
critical
component
of
the
Pennsylvania
study.
EPA
may
want
to
note
the
stakeholder
element
of
the
project
as
part
of
its
strategy,
in
addition
to
the
technical
aspects
already
noted.
A
stakeholder
group
will
involve
the
public
in
the
research,
ultimately
enhancing
its
acceptability.

Response
EPA
agrees
with
these
comments.

EPA
Log
#
46:
Association
of
Metropolitan
Sewerage
Agencies
(
AMSA)

Comment
Exposure
AMSA
supports
the
Agency's
plans
to
collect
and
review
currently
available
exposure
information
from
published
literature,
federal
and
state
databases,
the
NRC
Report,
and
other
relevant
sources
to
identify
data
gaps
and
its
plans
to
use
a
risk
assessment
framework
to
evaluate
priorities
for
reassessing
or
updating
underlying
components
including
exposure
assumptions
of
previously
conducted
risk
assessments.
AMSA
supports,
to
the
extent
resources
permit,
reviewing
exposure
information
used
in
the
Round
One
and
Round
Two
rules
in
light
of
new
exposure
information,
and
supports
updating
that
exposure
information
if
new
data
indicate
that
such
changes
are
necessary
to
protect
human
health.
AMSA
cautions
the
Agency
to
employ
a
consistent
approach
in
identifying
and
determining
exposure
pathways
for
ongoing
and
new
studies.

Response
Please
see
the
EPA
response
to
Comment
Log
Nos.
29,
40,
and
43.

Counties
USEPA,
2003d
31
EPA
Log
#
28:
Solano
County
Department
of
Environmental
Management
Comment
1.
Exposure
of
humans,
animals
and
the
environment
to
pathogens
and
contaminants
in
biosolids
A)
Aerosol
Transmission
Potential
aerosol
transmission
of
pathogens,
odorants,
toxic
compounds,
and
particulates
is
of
high
concern
for
many
Solano
County
citizens.
Solano
County
is
located
along
the
Sacramento
River
Delta
and
can
routinely
experience
wind
speeds
over
land
application
sites
of
over
20
mph
with
gusts
into
the
30
+
mph
range
for
several
days.
Solano
County
DEM
is
concerned
that
the
aerosol
study
detailed
in
the
USEPA
response
will
not
be
thorough
enough
to
capture
all
conditions
that
may
lead
to
potential
aerosol
transmission,
especially
as
a
result
of
sustained
high
wind
conditions,
and
is
focused
on
pathogens
only.
We
suggest
that
additional
field
studies
specific
to
researching
aerosol
transmission
of
pathogens
and
contaminates
be
undertaken
at
a
number
of
locations
throughout
the
nation
and
under
different
variables,
especially
during
sustained
high
wind
periods
such
as
those
observed
in
Solano
County.
It
should
be
noted
that
a
bioaerosol
study
noted
in
the
USEPA
response
did
occur
in
Solano
County,
but
the
sampling
events
did
not
occur
during
sustained
high
winds.
Therefore,
Solano
County
DEM
would
recommend
additional
testing
in
high
winds.

For
any
aerosol
study
Solano
County
DEM
suggests
that
sampling
events
take
into
account
all
wind
characteristics
so
that
sampling
stations
are
placed
in
locations
that
are
likely
to
receive
the
majority
of
downwind
dispersal.
Characteristics
such
as
wind
direction,
up
drafts
and
down
drafts
need
to
be
determined.
Placement
of
sampling
stations
at
downwind
sensitive
receptors,
in
addition
to
the
land
application
sites,
may
be
desirable
based
upon
all
wind
characteristics.

B)
Movement
of
contaminants
and
nutrients
Solano
County
DEM
also
recommends
that
as
part
of
the
exposure
studies,
the
potential
for,
and
actual
movement
of,
contaminants
and
nutrients
through
the
environment
in
relation
to
the
nitrate
and
total
metal
loading
rate
as
well
as
pathogen
and
organic
or
non­
organic
chemical
content,
and
landscape
and
topographical
features
at
the
application
site
be
determined.

Response
Please
see
the
EPA
responses
for
Comment
Log
Nos.
29
and
40.
EPA
also
recognizes
that
the
studies
referred
to
in
the
response
to
Comment
Log
No.
40
are
strongly
influenced
by
site­
specific
conditions
such
as
those
delineated
in
Solano
County,
California.
Field
studies
must
be
designed
and
performed
with
these
site­
specific
factors
in
mind.

States
EPA
Log
#
48
and
39
(
duplicates):
Wisconsin
Department
of
Natural
Resources
Comment
8.
Section
VIII.
B.
Exposure
­
Exposure
research.
(
A)
A
joint
study
between
EPA,
USDA,
and
the
Pennsylvania
DEP
is
cited.
The
following
specific
details
should
be
provided
in
the
four
objectives
listed
for
this
project:
USEPA,
2003d
32
(
1)
What
characterization
is
performed
on
the
untreated
sludge?
This
should
include
specific
pathogens
or
indicator
organisms
for
which
an
analysis
is
conducted,
as
well
as
chemicals
and
physical
properties.
(
2)
What
pathogens
and
analytes
are
characterized
in
air
samples?
(
3)
How
is
the
treatment
process
characterized?
Will
correlations
be
made
between
mean
cell
residence
time,
temperature,
mixing
efficiency,
and
other
factors
and
pathogen
density
throughout
the
process?
Will
enough
systems
be
monitored
to
draw
conclusions
that
can
be
applied
to
design
standards?
This
is
critical
work
and
should
be
done
comprehensively
on
a
large
enough
scale
to
draw
meaningful
conclusions,
as
recommended
in
the
report.
(
4)
What
pathogens
and
analytes
will
be
characterized
in
Class
B
sludge
and
through
the
natural
attenuation
process?
What
physical,
chemical,
and
biological
factors
will
be
examined
in
this
process
(
desiccation
in
soil,
UV
intensity
from
sunlight,
temperature,
etc.)?
Will
enough
sites
and
biosolids
be
monitored
to
draw
conclusions
that
can
be
used
to
verify
or
dispel
natural
attenuation
assumptions?
This
is
critical
work
and
should
be
done
comprehensively
on
a
large
enough
scale
to
draw
meaningful
conclusions,
as
recommended
in
the
report.
(
B)
What
distances
will
exist
between
the
point
of
application
and
the
fence
line
where
air
samples
will
be
collected
for
up
to
thirty
days?
It
may
be
necessary
to
sample
at
intermediate
spots
as
well.
9.
Section
VIII.
B.
Exposure
­
Planned
Exposure
Activities
­
It
is
mentioned
that
a
molecular
pathogen
tracking
study
will
be
done
as
part
of
the
joint
PA/
EPA/
USDA
study
at
additional
land
application
sites
in
Pennsylvania.
This
type
of
study
is
highly
recommended
but
it
is
not
assumed
that
the
study
sites
in
Pennsylvania
are
areas
where
allegations
of
adverse
health
effects
have
been
made.
The
study
should
not
be
in
a
pre­
determined
location
but
rather
done
as
the
need
arises.
While
there
appear
to
have
been
no
medical
diagnosis
for
any
of
the
complainants
in
areas
of
alleged
impacts
(
CA,
FL,
and
AZ);
there
have
been
allegations
made.
This
would
appear
to
be
the
type
of
area
where
such
studies
should
be
concentrated.
EPA
should
develop
and
articulate
a
proposal
for
activities
in
areas
where
allegations
have
been
made.
Such
studies
should
be
developed
in
consultation
with
state
regulators
and
local
health
agencies
and
the
CDC.

Response
Please
see
the
EPA
response
to
Comment
log
No.
40.

TOPIC
C.
RISK
ASSESSMENT
Summary
Response
The
reader
will
see
no
specific
short­
term
commitments
for
reevaluating
the
current
risk
assessments
that
serve
as
the
technical
bases
of
Rounds
One
and
Two
regulatory
actions.
It
should
be
noted
that
the
screening
analysis
used
to
identify
potential
chemical
pollutants
for
possible
future
additions
to
the
Part
503
Standards
discussed
in
today's
notice
uses
the
probabilistic
multi­
pathway
screening
analysis.
However,
EPA
will
evaluate
information
that
will
be
available
from
the
following
project
in
Section
VII
B
of
today's
Federal
Register
notice
for
use
in
potential
long­
term
risk
assessment
revisions
in
the
Part
503
program:

Project
12:
Support
"
Sustainable
Land
Application
Conference"
USEPA,
2003d
33
The
purpose
of
this
conference
will
be
to
address
soil
reactions
of
constituents
in
treated
sewage
sludge,
manures,
and
other
non­
hazardous
wastes,
and
to
further
environmentally
friendly
management
of
wastes
in
a
sustainable
manner.
This
January
2004
conference
in
Lake
Buena
Vista,
Florida
will
address
soil
constituents
(
chemicals
and
microorganisms)
reactions
with
constituents
in
treated
sewage
sludge,
wastewater
treatment
plant
effluents,
manures,
and
other
non­
hazardous
wastes.
Further,
this
international
conference
is
expected
to
have
about
300
participants
discussing
metals,
pathogens,
organics,
nutrients,
and
the
interface
between
science
and
real­
world
applications
by:
°
reviewing
fundamental
and
specific
soil
reactions
of
non­
hazardous
waste
constituents
(
nutrients,
organics,
metals
and
pathogens);
°
improving
our
understanding
of
contaminant
reactions
in
soils,
emphasizing
the
commonalities
of
soil
reactions
among
wastes;
°
synthesizing
multi­
disciplinary
information
and
characterizing
the
state­
of­
the­
science
for
land
application
(`
what
do
we
know?");
°
identifying
high­
priority
and
critical
research
needs
("
what
do
we
need
to
know?");
and
°
promoting
intra­
and
inter­
disciplinary
approaches
to
solving
problems
of
sustainable
waste
disposal
and
utilization.
Papers
and
presentations
will
be
both
invited
and
volunteered.
All
papers
will
be
refereed
and
EPA
will
use
conference
findings,
as
appropriate,
in
future
refinements
of
Part
503.

Academia
EPA
Log
#
51:
Ellen
Z.
Harrison
Comment
EPA
makes
only
a
vague
statement
regarding
involving
stakeholders
in
revising
the
RA
and
makes
no
commitment
to
do
so
(
p
17386).
Where
EPA
discusses
the
approach
EPA
will
take
to
consider
RA
revisions,
no
mention
is
made
of
stakeholders
(
p
17387­
8).
EPA
cites
a
"
recent"
PA
study
as
involving
stakeholders
in
"
scenario
development
and
regulatory
processes"
and
mentions
the
role
of
the
ISG.
That
statement
is
misleading
and
incorrect.
The
study
has
yet
to
commence
so
it
is
not
a
recent
study.
The
ISG
participants
were
not
involved
in
scenario
development.
We
have
had
very
limited
influence
on
the
study
design,
locations
or
research
protocols.
In
fact
a
frustration
has
been
that
the
ISG
was
not
brought
in
early
enough
to
consider
the
appropriate
research
objectives.
EPA
should
involve
stakeholders
from
the
very
beginning
of
any
research
or
risk
assessment
pertaining
to
sludge
application.
The
stakeholders
need
to
be
engaged
early
enough
to
help
formulate
the
questions
that
are
being
addressed.
Since
many
stakeholders
are
volunteers,
it
will
be
necessary
to
find
ways
to
support
their
involvement.

EPA
states
that
it
will
reassess
methods
and
data
for
previously
evaluated
and
new
pollutants,
but
makes
no
mention
of
the
many
specific
issues
raised
by
NRC
 
like
treatment
of
uncertainty
and
variability.

EPA
"
may"
consider
multiple
exposures,
sensitive
populations,
and
contaminant
interactions.
This
is
not
adequate.
EPA
states
that
it
will
look
at
risks
to
children
and
sensitive
populations
in
future
assessments
and
reassessments.
However,
it
does
not
say
explicitly
that
EPA
will
undertake
USEPA,
2003d
34
such
a
review
for
the
sludge
RA.
EPA
needs
to
commit
to
revising
the
RA
to
address
multiple
exposures,
sensitive
populations
(
including
children
and
fetuses),
and
contaminant
interactions.

EPA
appears
to
be
saying
it
is
up
to
each
state
to
determine
how
local
conditions
may
increase
risk
and
thus
determine
the
need
for
more
stringent
regulations
and
enact
them
as
they
choose.
Clearly
under
the
Clean
Water
Act,
the
states
have
that
right.
However,
as
pointed
out
by
the
NRC,
the
federal
rules
must
be
protective
under
reasonably
anticipated
high
risk
conditions.
Thus
citizens
and
the
environment
in
states
that
do
not
enact
more
stringent
rules
must
be
protected
under
the
federal
rules.
This
means
that
the
risks
must
be
assessed
under
reasonably
worst
case
conditions.
An
example
given
in
the
NRC
report
is
that
for
the
potential
exposure
to
sludge
contaminants,
conditions
such
as
karst
when
direct
flow
into
groundwater
without
travel
through
intervening
soil
must
be
considered
in
the
RA.
There
are
many
such
examples
of
reasonable
"
worst
case"
assumptions
that
need
to
be
taken
into
account.
For
example,
sludge
application
rates
as
high
as
42
MT/
hectare
in
Californa
(
see
email
below)
rather
than
the
10
MT/
ha
assumed
in
the
RA
done
to
develop
the
503
rules.

EPA
states
that
it
will
review
exposure
information
used
in
Rounds
1
and
2
to
identify
data
gaps,
inform
future
RA,
assess
needs
for
studies
and
will
review
published
literature,
federal
and
state
databases,
NRC
report,
other
sources.
The
paragraph
that
follows
this
proposed
action
(
p
17386)
discusses
studies
showing
that
bioavailability
assumptions
made
in
current
RA
are
too
conservative.
However,
a
recent
study
of
snails
showed
that
cadmium
was
more
bioavailable
than
predicted
(
Scheifler,
et
al,
2003).

Noteworthy
in
EPA's
response
is
that
no
mention
is
made
of
any
assumptions
that
they
used
in
the
current
RA
that
may
not
be
adequately
protective.
EPA
continues
to
assert
that
"
the
part
503
numerical
standards
are
based
on
a
conservative
set
of
exposure
pathway
and
risk
assessment
assumptions
(
p
17391).
That
statement
flies
in
the
face
of
much
of
the
NRC
report
which
sets
forth
numerous
examples
of
assumptions
in
the
RA
that
are
not
conservative.
Previous
work
has
also
pointed
out
that
many
of
the
assumptions
in
the
RA
are
not
conservative
as
did
a
more
general
review
(
Harrison,
et
al,
1999).

A
review
of
an
EPA
RA
of
dioxins
in
sludges
documented
many
non­
conservative
assumptions
(
Harrison,
1999).
In
response
to
this
and
other
criticisms,
EPA
contracted
for
a
revised
RA
for
dioxins
in
sludges.
While
a
significant
improvement
was
achieved
with
the
use
of
probabilistic
tools,
the
revised
RA
continued
to
use
many
deterministic
values,
many
of
which
were
not
appropriately
conservative.
Some
of
the
probabilistic
assumptions
were
also
not
relevant
to
reasonable
worst
case.
For
example,
the
revised
risk
assessment
for
dioxins
in
biosolids
addressed
regional
differences
by
relying
on
a
database
that
divides
the
country
into
41
distinct
regions
on
the
basis
of
climate
and
other
factors.
Meteorological
data
from
each
region
were
used
in
the
risk
assessment
to
predict
a
distribution
of
annual
average
air
concentrations
of
volatiles
in
air
at
land
application
sites.
Average
values
are
not
appropriate
in
assessing
the
reasonable
worst
case
exposure.
Biosolids
are
generally
spread
during
the
growing
season
and
not
under
winter
conditions.
Therefore,
warmer
temperatures
and
higher
rates
of
volatilization
would
be
expected
at
the
time
biosolids
are
applied.
This
issue
will
be
particularly
important
in
the
valuation
of
USEPA,
2003d
35
short­
term
exposures.
So,
for
example,
for
these
exposures,
risks
posed
under
high­
wind
and
high­
temperature
conditions
should
be
assessed.

The
April
9
document
indicates
that
EPA's
perspective
continues
to
ignore
the
many
non­
protective
assumptions.
This
is
one
reason
why
it
would
seem
imperative
to
have
ORD
rather
than
OW
undertake
the
review
and
revision
on
the
RA
for
sludge
land
application.

Response
Concerning
the
first
paragraph
of
the
comments,
EPA
is
committed
when
revising
sewage
sludge
risk
assessment
to
working
with
its
stakeholders,
including
the
general
public,
state
and
local
agencies,
industry,
and
private
groups.
EPA
is
also
committed
to
considering
how
to
implement
NRC's
recommendations
to
involve
stakeholders
to
update
and
strengthen
the
scientific
credibility
of
the
sewage
sludge
regulations.

In
response
to
paragraph
two,
EPA
will
examine
more
closely
uncertainties
in
the
screening
analysis
during
a
future
refined
risk
characterization
phase.
Analysis
of
uncertainties
will
include
exposure
scenario,
model
and
parameter
uncertainties.
In
addition,
EPA
expects
that
the
more
refined
risk
characterization
will
include
results
of
a
sensitivity
analysis.

EPA
disagrees
with
the
comment
in
the
third
paragraph
that
potential
health
effects
to
children
or
developing
fetuses
are
not
being
addressed
in
the
sewage
sludge
risk
assessment.
In
assessing
risks,
EPA
uses
Agency­
generated
toxicity
values,
including
the
Integrated
Risk
Information
System
(
IRIS)
and
Office
of
Pesticide
Programs
(
OPP)
values,
which
are
established
taking
into
account
sensitive
subgroups
(
such
as
pregnant
women,
infants,
children
and
the
elderly),
to
the
extent
that
such
information
is
available
at
the
time
of
the
health
assessment.
In
addition,
EPA
includes
infants
and
children
in
the
exposure
scenario
when
assessing
potential
risk
from
exposure
to
chemical
contaminants
in
sewage
sludge.
EPA
will
consider
exposure
to
mixtures
and
contaminants
interactions
to
the
extent
that
the
information
and
risk
assessment
methodology
are
available
to
adopt
such
approaches.

Paragraph
four
and
six
of
the
comments
state
that
risks
must
be
assessed
under
reasonable
worst
case
conditions.
EPA
has
adopted
many
conservative
assumptions
in
this
screening
analysis
(
Please
see
section
VIII
of
the
FR
notice:
Modeling
Assumptions
for
Conducting
a
Screening
Analysis
for
Part
503).
On
the
other
hand,
EPA
may
adopt
a
less
conservative
assumption
when
the
conservative
assumption
is
judged
to
be
unrealistic.

Regarding
paragraph
5,
EPA
has
reconsidered
its
position
on
reevaluating
the
exposure
analysis
that
it
performed
as
the
technical
basis
for
the
Part
503
Round
One
Standards.
For
additional
details
please
see
EPA
Response
to
Log
#
43.
With
respect
to
the
comments
on
dioxins,
EPA's
final
determination
not
to
regulate
dioxins
in
land­
applied
sewage
sludge
was
published
in
the
Federal
Register
has
concluded
on
October
24,
2003
at
68
Fed.
Reg.
61084.
Round
Two
Part
503
probabilistic
risk
assessment
and
will
not
address
comments
related
to
dioxins
in
this
document.
USEPA,
2003d
36
Finally,
the
screening
activity
to
identify
potential
pollutants
for
future
additions
to
the
Part
503
Standards
does
employ
the
"
state
of
the
art"
exposure
analysis
and
probabilistic
exposure
model
Any
future
rulemaking
involving
pollutants
that
were
subjected
to
this
screening
activity
will
undergo
a
public
comment
period
where
all
stakeholders
will
be
able
to
comment
on
EPA's
technical
approach.

Citizens
EPA
Log
#
8:
David
A.
Burrows
Comment
Research
by
the
Water
Environment
Research
Foundation
(
Federal
Register
p.
17387),
an
industry
sponsored
group,
will
be
suspect
because
of
its
ties
to
the
wastewater
industry.
This
emphasizes
the
need
for
selecting
researchers
through
the
Request
for
Proposal
process.
Also,
peer
review
is
needed
in
at
least
two
stages:
a)
peer
review
of
study
design;
b)
peer
review
of
the
draft
report.

Response
WERF's
stated
mission
is
to
provide
a
"
balanced
water
quality
research
program
addressing
current
wastewater
research
needs
and
forecasting
future
directions."
For
fiscal
years
1999
through
2001,
EPA
awarded
$
9.6
million
to
WERF
which
was
Congressionally
mandated.
With
funds
provided
by
EPA,
WERF
subcontracts
to
other
organizations
to
perform
the
research.
EPA
will
review,
evaluate,
and
utilize
all
relevant
data
that
meets
the
standards
for
data
quality
as
specified
in
EPA's
Data
Quality
Guidelines.
EPA
rejects
suggestions
that
the
data
being
generated
by
any
one
organization
is
necessarily
biased
or
unreliable
due
to
an
advocacy
position
that
this
organization
may
have.
Please
see
the
EPA
response
to
Comment
Log
No.
40
in
the
Exposure
Section
of
this
document
with
respect
to
EPA's
position
on
study
design
peer
review
EPA
Log
#
29:
Henry
J.
Staudinger
Comment
C.
EPA's
Risk
Assessment
Strategy
is
Not
Adequate.
NRC
Recommends
that
EPA
use
improved
risk
assessment
methods
for
chemicals
and
pathogens;
as
well
as
to
ensure
that
local
conditions
are
considered
and
the
underlying
risk
assessment
principles
are
effectively
translated
into
practice.

EPA
provides
little
assurance
that
state­
of­
the­
science
risk
approaches
will
be
used.
In
any
event,
any
such
effort
will
be
severely
limited
by
the
lack
of
input
data
as
discussed
earlier.
EPA's
proposal
to
evaluate
key
pollutants
and
pathways
likely
to
be
of
greatest
concern
or
where
new
scientific
developments
may
have
the
greatest
impact
is
further
flawed
in
that
EPA
does
not
intend
to
scientifically
determine
what
pollutants
are
key.

The
EPA/
USDA/
DEP
Information
Sharing
Group
is
cited
as
an
example
of
identifying
stakeholder
concerns
and
ensuring
transparency.
However,
EPA
fails
to
make
clear
that
the
Pennsylvania
project
has
not
been
designed
to
address
the
human
health
issues
identified
by
NRC
and
the
public.
USEPA,
2003d
37
EPA
also
provides
no
assurance
that
its
risk
assessment
strategy
will
protect
sensitive
individuals
such
as
the
immune
compromised;
that
biosolids
will
not
be
precluded
in
local
pollution
sensitive
situations;
or
even
that
risk
management
principles
will
be
put
into
practice.
By
continuing
existing
practices,
EPA
raises
the
real
possibility
that
needed
changes
will
never
be
implemented.

Response
Please
see
the
EPA
response
to
Comment
Log
No.
51
in
this
section.

EPA
Log
#
33:
Citizens
for
Sludge­
Free
Land
(
CSFL)

Comment
Synagro
Technologies
Inc.
appears
to
apply
the
same
standard
dose­
response
models
for
assessing
risks
from
carcinogens
as
risks
from
endocrine
disrupters.
Although
some
chemicals
are
both
carcinogens
and
endocrine
disrupters,
cancer
and
endocrine
disruption
are
two
very
different
physiological
disorders.
The
dose­
response
paradigm
used
for
cancer
risks
can
not
be
used
for
chemicals
that
interfere
with
the
proper
functioning
of
the
endocrine
system.
Damage
to
this
system
can
be
caused
by
very
small
amounts
of
the
offending
compound,
measured
in
parts
per
trillion.
Damage
depends
primarily
on
when
a
developing
organism
is
exposed.

Synagro
Technologies
Inc.
as
well
as
EPA,
ignore
the
NRC
conclusion
that
sewage
sludges
are
such
an
unpredictable
and
complex
mixture,
that
no
reliable
risk
assessment
is
possible
for
this
contaminated
material.

Response
EPA
thank
the
commenter
for
the
views
and
information
provided
which
will
be
considered
when
carrying
out
the
Agency's
planned
activities.

EPA
Log
#
37:
David
A.
Burrows
Comment
On
page
17384
of
the
Federal
Register,
the
short
term
goals
fail
to
call
for
risk
assessments
of
chemical
pollutants
and
pathogens
found
in
biosolids.
Such
risk
assessments
were
an
overarching
recommendation
as
stated
on
page
4
of
the
National
Research
Council
Report
on
Biosolids
Applied
to
Land
(
NRC
Report).

At
the
bottom
of
the
Federal
Register
page
17387
and
the
top
of
page
17388
is
the
only
clear
mention
in
section
2
of
"
The
Agency's
Response
for
the
Risk
Assessment
Category"
of
risk
assessment
in
relation
to
pathogens.
This
brief
mention
is
not
adequate.
EPA
proposes
"
to
continue
its
efforts
to
evaluate
and
develop
new
methods
for
pathogen
risk
assessments
and
improved
models
for
exposure
assessments."
Pathogen
related
risk
assessments
need
to
be
done
now.

Response
With
respect
to
chemical
pollutants
risk
assessment,
please
see
the
EPA
response
to
Comment
Log
No.
51
in
this
section
of
the
document.
With
respect
to
pathogen
risk
assessment,
Section
VII
B
of
today's
Federal
Register
Notice
describes
Project
8
"
Assess
the
Quality
and
Utility
of
Data,
Tools
and
Methodologies
to
Conduct
Microbial
Risk
Assessments
on
Pathogens".
USEPA,
2003d
38
To
better
inform
research
activities
in
sewage
sludge
and
microbial
risk
assessment,
EPA
will
inventory
and
assess
data,
methods,
and
tools
for
risk
assessment
on
pathogens
in
sewage
sludge.
The
NRC
report
indicated
that
additional
scientific
work
is
needed
to
reduce
persistent
uncertainty
about
the
potential
for
adverse
human
health
effects
from
exposure
to
biosolids.
The
document
goes
on
to
recommend
that
EPA
use
improved
risk
assessment
methods.
EPA
currently
regulates
the
processing,
use,
and
disposal
of
sewage
sludge
through
CWA
regulations
in
Part
503,
that
impose
numeric
standards
and
management
practices
for
sewage
sludge
applied
to
land.
For
the
most
part,
the
numeric
standard
for
chemical
pollutants
in
existing
regulations
are
risk­
based,
while
the
microbial
management
practice
standards
are
technology­
based.
In
issuing
Part
503
in
1993,
the
Agency
acknowledged
that
it
lacked
essential
tools
and
data
to
conduct
microbial
risk
assessments
on
sewage
sludge.
This
project
will
address
those
microbial
risks
posed
by
exposure
to
sewage
sludge,
it
will
serve
as
a
vehicle
to
better
define
the
deficiencies
in
microbial
risk
assessment,
and
better
identify
research
needs
for
sewage
sludge
risk
assessment.

The
project
will
start
with
a
problem
formulation
step
to
identify
the
key
elements
in
assessing
pathogen
risks
in
land­
applied
sewage
sludge.
During
the
second
phase,
EPA
will
develop
a
plan
to
identify
the
available
and
appropriate
methods
and
data
to
perform
the
risk
assessment
defined
in
problem
formulation.
An
expert
panel
will
review
the
material
and
EPA
will
address
panel
comments
in
the
final
document.
This
project
will
serve
as
a
vehicle
to
better
define
the
deficiencies
in
microbial
risk
assessment
and
better
identify
research
needs
for
microbial
risk
assessment
in
sewage
sludge
matrices.
The
final
product
in
FY
2005
will
be
a
peer­
reviewed
plan
for
future
analysis.

EPA
will
develop
a
scenario
that
includes
issues
involved
in
the
risk
assessment:
sources
of
organisms,
potential
receptors,
routes
of
exposure,
and
environmental
and
management
conditions
affecting
exposure.
The
scenario
will
also
identify
pathogens
based
on
studies
of
the
composition
of
sewage
sludge,
incidence
of
contamination
reported
in
the
literature,
and
numbers
of
organisms
recovered
from
sewage
sludge.
The
Agency
will
develop
rates
and
methods
of
application
as
well
as
at­
risk
populations
(
such
as
those
with
occupational
exposures
or
those
living
near
application
sites).
The
study
will
also
consider
sensitive
populations
such
as
children,
the
elderly,
or
those
persons
with
immune
system
problems.
We
will
develop
a
conceptual
model
to
characterize
different
routes
of
exposure
to
microbes
under
realistic
scenarios.
The
workgroup
will
lay
the
foundation
for
defining
the
conditions
and
criteria
for
microbial
risk
assessments
of
sewage
sludge.

The
workgroup
will
also
review
the
scientific
literature
to
identify
available
tools,
methods
and
data,
as
well
as
gaps,
for
conducting
an
assessment
under
the
defined
conditions.
An
expert
panel
will
critique
findings
and
recommend
future
research
for
microbial
risk
assessment
of
sewage
sludge.

Finally,
EPA
is
aware
and
tracking
the
progress
and
will
eventually
evaluate
the
results
and
reports
from
two
external
academic
entities.
Researchers
at
the
University
of
California
at
Berkeley
and
the
National
Science
Foundation's
Water
Quality
Center
at
the
University
of
Arizona
are
developing
quantitative
microbial
risk
assessments
applicable
to
the
land
application
USEPA,
2003d
39
of
sewage
sludge.
EPA
anticipates
that
these
external
projects
will
complement
EPA's
effort
in
the
development
of
quantitative
microbial
risk
assessment
techniques.

EPA
Log
#
40:
Thomas
F.
Albert
Comment
Comment
#
3:
On
page
17384
the
short
term
goals
do
not
call
for
actually
conducting
risk
assessments
regarding
chemicals
and
pathogens.
Goal
#
2
mentions
the
need
to
"
Evaluate
the
state­
of­
the­
science
and
revise
assessment
methodologies,
as
appropriate."
This
timid
EPA
action
does
not
properly
respond
to
the
first
NRC
overarching
recommendation
(
page
4
of
NRC
report)
that
states
"
­­­
(
1)
new
risk
assessments
should
be
conducted
to
update
the
scientific
bases
of
the
chemical
limits,
and
(
2)
risk
assessments
should
be
used
to
supplement
technological
approaches
to
establishing
regulatory
criteria
for
pathogens
in
biosolids."
The
NRC
report
calls
for
RISK
ASSESSMENTS
in
its
overarching
recommendations
(
page
4
NRC
report)
but
EPA
seems
to
ignore
the
NRC
overarching
recommendations.
Why
is
this?

Comment
#
17:
On
pages
17385
and
17386
in
the
section
"
2.
The
Agency's
Response
to
the
Exposure
Category",
EPA
mentions
reviewing
available
data
regarding
"
decisions
about
future
risk
assessments."
EPA
seems
to
"
dance
around"
the
issue
of
doing
risk
assessments
regarding
chemicals
and
pathogens.
EPA
makes
no
commitment
to
doing
risk
assessments.
EPA's
response
is
inadequate
regarding
risk
assessments.
The
first
overarching
recommendation
from
the
NRC
report
(
page
4)
calls
for
EPA
to
"
Use
improved
risk
assessment
methods
to
better
establish
standards
for
chemicals
and
pathogens."
If
EPA
is
going
to
only
"
study"
the
idea
of
doing
risk
assessments
then
it
ignores
the
clear
urging
of
the
NRC
report.
If
EPA
is
going
to
ignore
the
NRC
overarching
recommendation
regarding
risk
assessments,
then
EPA
should
clearly
explain
WHY
it
will
ignore
the
NRC
recommendation.

Comment
#
20:
The
section
"
2.
The
Agency's
Response
for
the
Risk
Assessment
Category"
on
page
17386
to
top
of
page
17388
is
poorly
written
and
is
confusing.
Nearly
all
of
the
risk
assessment
discussion
seems
to
pertain
to
POLLUTANTS.
By
pollutants
does
EPA
only
mean
chemicals
(
and
not
pathogens)?
If
this
is
the
case
then
EPA
should
clearly
state
that.
There
is
only
ai
tiny
mention
of
pathogens
in
relation
to
risk
assessment.
Presented
below
as
items
A­
G
are
specific
comments
regarding
this
section.

A.
EPA
states
"
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."
Does
this
mean
that
risk
assessment
only
pertains
to
POLLUTANTS?
Do
pollutants
include
pathogens?

B.
EPA
states
"
Previously,
EPA
used
a
risk
based
approach
for
estimating
risks
to
human
health
and
developing
management
practices
to
reduce
risks
and
set
protective
standards.
"
This
is
misleading.
Regarding
pathogens,
PA
did
NOT
use
the
risk
assessment
approach
to
establish
the
1993
pathogen
standards
for
Class
A
and
Class
B
sewage
sludge
(
see
NRC
report
pages
13,
257,
332).
USEPA,
2003d
40
C.
EPA
states
"
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."
This
is
MISLEADING.
'
The
NRC
report,
when
referring
to
stakeholder
involvement,
did
not
say
that
they
COULD
be
included.
Rather
the
NRC
says
that
stakeholders
SHOULD
be
included
(
see
pages
13
and
332
of
NRC
report).
Why
does
EPA
take
a
direct
quote
(
regarding
stakeholders)
from
page
13
of
the
NRC
report,
but
EPA
uses
COULD
involve
rather
than
SHOULD
involve?
Is
this
a
deliberate
case
of
"
weakening"
an
NRC
recommendation?

D.
At
the
top
of
page
17387
is
mentioned
stakeholder
involvement
in
a
"
recent
study
in
Pennsylvania."
An
information
sharing
group
is
also
mentioned.
Is
this
the
same
cooperative
study
by
EPA/
USDA/
PA
mentioned
earlier
on
page
17386?
If
it
is
the
same
study
EPA
should
mention
how
FEW
concerned
citizens
are
involved
in
that
project's
information
sharing
group.

E.
On
page
17387
there
are
2
mentions
of
PEER
REVIEW.
Will
EPA
commit
to
proper
peer
review
of
the
study
DESIGN
and
the
DRAFT
FINAL
REPORT
for
sludge
related
studies
that
it
funds
and/
or
conducts?
If
EPA
will
commit
(
in
the
final
version
of
these
EPA
comments)
to
such
peer
review
of
study
design
and
draft
final
reports,
it
will
help
to
assure
quality
science
and
will
enhance
EPA
credibility.

F.
At
the
bottom
of
page
17387
and
the
top
of
page
17388
is
about
the
only
clear
mention
(
11
lines)
in
this
section
of
risk
assessment
in
relation
to
PATHOGENS.
This
brief
mention
is
inadequate.
EPA
proposes
"
to
continue
its
efforts
to
evaluate
and
develop
new
methods
for
pathogen
risk
assessments
and
improved
models
for
exposure
assessments."
Why
doesn't
EPA
conduct
pathogen
related
risk
assessment
studies
NOW?
Why
more
delay?

G.
The
sentence
(
4
lines)
starting
at
the
bottom
of
page
17387
and
extending
over
to
the
top
of
page
17388
is
quite
interesting.
It
again
says
what
EPA
MAY
do
regarding
human
health.
The
sentence
states
"
EPA
may
also
evaluate
and
assess
data
and
information
related
to
multiple
exposures,
potential
contaminant
interactions,
and
potential
effects
on
sensitive
subpopulations,
to
the
extent
the
state­
of­
the­
science
is
available."
Here
again,
in
a
health
related
matter,
EPA
MAY
"
evaluate
and
assess
data."
Why
MAY?
Why
not
actually
do
it?

Response
EPA
is
focusing
on
both
chemical
and
microbial
pollutants
in
sewage
sludge.
With
respect
to
microbial
risk
assessment,
please
see
the
EPA
response
to
Comment
Log
No.
37
of
this
section,
and
Project
8,
Section
VII
B
of
today's
Federal
Register
Notice
to
"
Assess
the
Quality
and
Utility
of
Data,
Tools
and
Methodologies
to
Conduct
Microbial
Risk
Assessments
on
Pathogens."
With
respect
to
chemical
pollutants
risk
assessment,
please
see
the
EPA
response
to
Comment
Log
No.
51
in
this
section
of
the
document,
and
the
EPA
response
to
Comment
Log
No.
40
in
the
Exposure
Section
of
this
document
with
respect
to
QA/
QC
and
peer
review.

EPA
Log
#
25:
Northumberland
Association
for
Progressive
Stewardship
(
NAPS)
Sewage
Sludge
Study
Group
USEPA,
2003d
41
Comment
C.
Risk
Assessment
Lines
647­
755.
Once
again,
the
EPA
response
is
disappointing.
The
NRC
recommendations
are
ignored,
and
EPA
plans
to
move
forward
``
on
the
cheap"
and
to
"
reassess
methods
and
data
used
for
previously
evaluated
pollutants,
and
apply
these
methods
to
new
pollutants."
Unfortunately,
the
final
sentence
is
typical
of
EPA's
plans
to
avoid
a
thorough
job
on
risk
assessment:
"
EPA
may
(
why
not
will)
evaluate
and
assess
data
and
information
related
to
multiple
exposures,
potential
contaminate
interactions,
and
potential
effects
on
sensitive
sub­
populations,
o
the
extent
the
state­
of­
the
art­
science
is
available."
We
propose
that
this
risk,
utilizing
new
scientific
data,
is
absolutely
essential
because
the
"
sludge
stew
"
obviously
contains
numerous
varieties
of
pollutants
and
their
interaction
must
be
evaluated.
Therefore,
we
recommend
that
this
work
must
be
done
in
order
to
adequately
protect
human
health,
and
if
not
available,
state­
of­
the­
art
research
be
conducted.

We
are
pleased
that
EPA
is
including
"
bioaerosols
"
in
its
reply.
We
believe
that
a
good
deal
of
the
illness
being
suffered
by
residents
near
land
application
sites
is
attributable
to
airborne
contaminants.

Response
Please
see
EPA
responses
to
Comment
Log
Nos.
51
and
37
of
this
section.

Environmental
Groups
EPA
Log
#
43:
Natural
Resources
Defense
Council
(
NRDC)

Comment
RISK
ASSESSMENT
&
METHODS
DEVELOPMENT
NRC
recommends
that
EPA
revise
and
update
the
outdated
risk­
assessment
("
RA")
methods
and
policies
for
biosolids
included
in
the
503
Rule.
EPA's
response
includes
a
general
plan
to
reassess
methods
and
data
used
for
previously
evaluated
and
new
pollutants,
but
fails
to
address
many
of
the
specific
issues
raised
by
NRC,
such
as
stakeholder
participation
and
treatment
of
uncertainty
and
variability.

EPA
indicates
that
it
plans
to
re­
evaluate
and
assess
risks
for
pollutants
in
sludge
with
a
focus
on
those
having
the
greatest
potential
risks
and
uncertainties.
NRDC
is
pleased
to
see
that
EPA
is
planning
to
focus
on
risk.
Specifically,
NRDC
urges
EPA
to
focus
on
those
pollutants
having
the
greatest
potential
risks
and
to
focus
not
only
on
human
health
risks,
which
is
the
way
that
EPA
defines
risk
assessment
for
purposes
of
this
federal
register
notice,
but
also
on
environmental
risks,
which
is
what
the
statute
requires.
EPA
is
obligated
to
protect
against
both
human
health
and
environmental
risks
from
sludge
disposal.
EPA
cannot
merely
ignore
such
risks
because
they
are
complex
or
difficult
to
assess.

EPA's
statement
that
it
will
assess
risks
to
children
and
sensitive
populations
in
the
future
is
an
encouraging
indication
of
EPA's
acceptance
of
current
science
regarding
varying
risk
throughout
different
segments
of
the
population.
However,
the
only
way
to
translate
this
general
acceptance
into
action
is
through
a
commitment
to
revise
the
risk
assessment
methods
and
procedures
to
account
for
children
and
sensitive
populations.
Unfortunately,
beyond
its
general
statement,
EPA
USEPA,
2003d
42
makes
no
further
mention
of
specific
changes
to
the
RA
process
that
actually
incorporates
this
new
"
policy."
EPA
needs
to
make
specific
changes
in
its
RA
process
to
ensure
that
sludge
regulations
are
protective
of
all
sensitive
populations
including
children,
the
elderly
and
those
with
impaired
immune
systems.

In
response
to
NRC's
recommendation
to
include
stakeholders
in
the
RA
process,
EPA
offers
only
that
it
"
intends
to
consider"
how
to
involve
stakeholders
in
the
process,
but
then
fails
to
commit
to
actually
doing
so.
In
fact,
later
in
the
very
same
section
of
its
response,
EPA
makes
absolutely
no
mention
of
stakeholders
when
describing
its
two­
step
process
for
addressing
the
NRC's
RA
recommendations.

EPA
misleadingly
suggests
that
the
informal
information
sharing
group
("
ISG")
­
created
to
provide
input
for
the
EPA/
USDA/
PA
study
­
exemplifies
a
widespread
policy
to
do
so
throughout
the
biosolids
program.
NRDC
is
unaware
of
any
other
examples,
and
EPA
fails
to
provide
any,
where
stakeholders
have
been
significantly
involved
in
biosolids
related
research
and
development
projects.
Indeed,
a
member
of
the
very
same
ISG
that
EPA
cites
says
that
the
Group's
input
into
the
EPA/
USDA/
PA
project
was
limited
by
the
fact
that
they
were
assembled
after
the
research
agenda
had
been
firmly
established.

Response
Please
see
EPA
responses
to
Comment
Log
No.
51
of
this
section.
In
this
FR
notice,
EPA
is
addressing
both
human
health
and
ecological
hazards.
The
ecological
screening
analysis
addresses
risks
to
terrestrial
and
aquatic
animals
and
plants,
the
receptors
that
are
expected
to
experience
the
highest
exposure
to
pollutants
in
land­
applied
sewage
sludge.
Ecological
hazard
quotients
(
HQs)
have
been
calculated
for
the
40
chemicals
passing
the
screening
analysis.
Chemicals
with
ecological
HQs
equal
to
or
greater
than
one
indicate
a
potential
for
adverse
ecological
effects
to
occur.
These
chemicals
will
be
included
in
a
targeted
national
survey.
A
more
refined
ecological
risk
assessment
and
risk
characterization
will
be
conducted
for
these
chemicals,
to
determine
whether
these
should
be
considered
for
regulation
under
Part
503.

Comments
of
Dr.
David
O.
Carpenter
Adequacy
of
the
EPA
Risk
Assessment
Assumptions:
The
EPA
risk
assessment
for
biosolids
is
based
on
a
10­
4
being
an
acceptable
risk
for
cancer,
not
the
more
protective
value
of
10­
6.
It
is
not
clear
why
the
less
protective
value
was
chosen,
particularly
in
that
regulation
at
a
more
protective
level
is
not
particularly
difficult
or
expensive.
EPA
frequently
applied
a
10­
4
value
on
occasions
where
a
more
restrictive
standard
would
be
unrealistic
to
achieve
or
incur
undo
expense.
This
is
simply
not
the
case
here.
Furthermore,
biosolids
are
a
complex
chemical
mixture,
and
may
contain
numerous
substances
known
or
suspected
to
be
carcinogenic.
We
have
little
or
no
information
on
whether
there
are
interactions
between
mixtures
of
pollutants
that
increase
risk
in
a
more
than
additive
fashion
(
Carpenter
et
al.,
2002).
Therefore
this,
in
the
authors
judgment,
is
an
unwise
level
of
protection
of
public
health.

EPA
risk
assessment
in
this
and
all
other
issues
is
based
on
the
assumption
that
there
is
no
threshold
for
increased
risk
of
cancer
for
those
substances
that
are
known
to
be
carcinogens,
but
that
this
is
not
true
for
non­
cancer
health
effects.
In
the
judgment
of
the
author,
this
latter
USEPA,
2003d
43
hypothesis
is
clearly
not
true
in
at
least
some
cases,
and
leads
to
a
significant
underestimation
of
the
importance
of
non­
cancer
health
effects.
The
example
of
lead
toxicity
is
a
case
in
point.
There
is
increasing
evidence
that
there
is
no
threshold
for
the
hazardous
effects
of
lead,
especially
considering
neurobehavioral
effects
in
the
developing
human
(
Canfield
et
al.,
2003).
As
with
many
toxicants
lead
affects
multiple
organ
systems,
probably
by
totally
independent
mechanisms.
Thus,
lead
causes
anemia
(
Schwartz
et
al.,
1990),
elevation
of
blood
pressure
(
Nash
et
al.,
2003),
interferes
with
reproduction
(
Apostoli
et
al.,
1998)
and
alters
immune
function
(
Kuo
et
all.,
2001).
Many
other
toxicants,
both
inorganic
and
organic,
cause
similar
effects,
and
a
major
question
remains
as
to
what
are
the
interactions
upon
exposure
to
more
than
one
contaminate
(
Carpenter
et
al.,
2002).

It
is
true
that
non­
cancer
endpoints
are
often
more
difficult
to
document,
especially
those
endpoints
that
relate
to
neurobehavioral
function
or
subtle
changes
in
the
immune
or
endocrine
systems.
However,
there
is
no
justification
for
the
assumption
that
these
endpoints
have
a
threshold
below
which
there
is
no
harm.
The
recent
studies
of
Schell
et
al.
(
2002)
on
thyroid
function
of
Native
Ameirican
adolescents
are
another
example.
These
investigators
found
that
while
serum
levels
of
polychlorinated
biphenyls
(
PCBs)
in
these
individuals
ages
10­
16
was
low
(
mean
1.81,
maximum
4.74
ppb),
there
was
a
direct
linear
relationship
with
thyrotropin
stimulating
hormone
(
TSH),
and
a
linear
inverse
relationship
with
free
and
total
thyroxine
(
T4)
levels.
While
the
perturbation
of
TSH
and
T4
were
not
outside
of
the
range
that
are
usually
considered
to
be
abnormal,
these
observations
demonstrate
that
PCBs
alter
physiologic
function
at
serum
concentrations
that
are
average
background
levels
in
the
general
population.

Response
The
issues
that
this
commenter
raises
are
scientific
policy
and
risk
management
in
nature.
EPA
uses
peer
reviewed
human
health
benchmarks
from
IRIS
or
OPP
as
scientifically
appropriate
end
points
in
human
health
risk
assessments.
EPA
risk
management
policies
allow
individual
EPA
programs
to
establish
acceptable
incremental
target
cancer
risk
levels
in
the
crafting
of
protective
human
health
standards.
In
conducting
its
exposure
and
hazard
screen,
EPA
has
chosen
a
risk
level
of
10­
5
for
the
farm
family.
See
section
VIII
of
the
notice
for
a
more
detailed
discussion
of
this
issue.

Comments
of
Dr.
Peter
L.
deFur
Risk
Assessment
Issues
NRC
noted
a
number
of
areas
in
which
the
1989
risk
assessment
no
longer
meets
the
standards
of
practice
in
EPA
in
2003.
The
present
comments
note
the
following
areas
that
need
to
be
addressed
and
are
not
now
in
the
503
rule
as
practiced
or
proposed
­
these
items
need
to
be
evaluated
in
the
new
rule
revisions.

1)
Failure
to
consider
multiple
pathway
exposures
is
a
common
problem
in
risk
assessments,
although
revisions
and
newer
procedures
attempt
to
remedy
this
situation.
At
present,
the
sludge
rule
has
only
limited
consideration
of
multiple
pathway
exposures.
This
problem
needs
to
be
corrected
by
evaluating
exposures
to
chemicals
from
all
possible
pathways
(
air,
water,
soil,
food,
dermal
contact,
recreational
contact)
in
single
scenarios,
rather
than
in
separated
scenarios.
This
approach
will
more
closely
approximate
the
more
highly
exposed
individuals.
USEPA,
2003d
44
2)
There
is
no
evidence
that
EPA
considered
the
fetus
in
the
assessment
of
risks
from
chemicals
and
pathogens
in
sewage
sludge.
This
omission
is
quite
significant,
as
the
developing
fetus
is
more
sensitive
to
a
number
of
toxic
chemicals
(
see
NRC,
2000).
As
a
cornpanion
problem,
even
if
EPA
considers
the
fetus
or
young
children
in
this
rule,
the
toxicity
reference
data
are
not
determined
for,
nor
set
to
protect
either
young
children
or
fetuses
in
the
IRIS
listings.
Congress
recognized
this
problem
in
the
Food
Quality
Protection
Act
of
1996
when
EPA
was
instructed
to
use
a
ten­
fold
(
10X)
safety
factor
for
children's
health
protection
in
setting
pesticide
tolerances
in
the
absence
of
specific
data.
EPA
can
follow
this
model
in
the
503
rule.

3)
No
synergies
or
other
interactions
were
included
even
in
the
same
pathways­
single
chemical/
single
pathway
exposures
were
considered
for
the
most
part.
There
were
some
multiple
pathway
exposures,
but
none
that
captured
the
full
range
of
exposure
conditions.

4)
In
addition,
several
of
the
risk
assessment
assumptions
or
conditions
were
not
appropriate.
The
NIOSH
and
ACGIH
standards
for
inhalation
were
developed
for
healthy
adults
in
occupational
settings,
not
residential
and
should
not
be
applied
to
residential
exposure
scenarios.
Residential
exposures
must
account
for
infirm,
elderly
and
infant
exposures.
No
adjustment
was
made
for
the
conditions
in
residential
exposures
compared
with
occupational
ones.

5)
The
risk
assessment
conditions
did
not
indicate
any
consideration
for
the
existing
body
burdens
of
many
chemicals.
As
shown
in
the
CDC
(
2003)
data
on
tissue
levels
of
contaminants,
the
average
human
carries
a
substantial
body
burden
of
many
of
these
chemicals,
and
these
existing
doses
have
to
be
counted
in
conducting
a
risk
assessment.

6)
EPA
conducted
the
risk
assessment
for
a
highly
exposed
person,
but
it
is
not
clear
that
EPA
adjusted
for
highly
sensitive
or
susceptible
persons,
especially
the
fetus.
Fetal
exposure
is
often
the
most
dangerous,
as
noted
for
lead
(
see
CDC
web
site
on
lead
exposure)
in
people.
A
number
of
investigations
on
PCBs
have
revealed
as
much
for
this
group
of
chemical
contaminants
as
well.

7)
EPA
continues
to
have
serious
regulatory
issues
concerning
the
group
of
chemicals
known
as
dioxins,
or
more
properly,
2,3,7,8,
tetrachlorodibenzo­
p­
dioxin
(
TCDD)
and
the
other
chlorinated
dioxins,
as
well
as
the
furans,
PCBs
and
some
other
chemicals,
that
act
through
the
same
mechanism
of
action.
EPA
determined
a
cancer
slope
factor
for
TCDD,
and
a
cancer
classification,
although
the
compound
is
not
formally
listed
in
the
IRIS
database.
The
National
Toxicology
Program
lists
TCDD
as
a
human
carcinogen
(
NTP
2001).
EPA
also
determined
an
RfD
for
TCDD
and
used
this
RfD
in
the
water
quality
criteria
process.
EPA
also
undertook
a
reassessment
of
the
risks
ofdioxin
exposure
in
1991,
yet
has
not
completed
the
reassessment
and
published
the
outcome.
Thus,
the
most
recent
official
positions
of
the
agency
remain
woefully
out
of
date,
pending
the
completion
and
official
publication
of
the
Dioxin
Reassessment.

Both
the
cancer
slope
factor
(
CSF)
and
the
RfD
for
TCDD
are
addressed
by
EPA
in
the
latest
dioxin
reassessment,
the
latest
draft
is
on­
line
as
of
the
year
2000.
EPA
does
have
a
CSF
for
dioxin
­
1.5
x
106
per
mg/
kg/
day,
although
the
latest
draft
of
the
dioxin
reassessment
calculates
an
increase
of
about
6
fold.
This
matter
may
be
resolved
through
means
other
than
the
reassessment
USEPA,
2003d
45
because
the
NTP
listed
dioxin
as
a
known
carcinogen.
In
the
interim,
EPA
should
at
minimum
calculate
the
sludge
risk
from
dioxin
based
on
both
cancer
slope
factors.

The
issue
with
non­
cancer
effects
is
less
straightforward.
The
dioxin
reassessment
states
that
the
agency
cannot
determine
an
RfD
at
this
time
because
the
US
population
at
present
has
an
average
exposure
(
also
an
average
body
burden)
that
exceeds
the
RfD
(
supposedly
a
"
safe
"
dose).
Nonetheless,
the
last
RfD
of
1.0
pg/
kg/
day
was
used
by
EPA
in
the
risk
assessment
for
the
cleanup
of
the
Times
Beach
Superfund
site.
EPA
needs
to
take
some
consistent
and
meaningful
steps
to
reduce
dioxin
formation
and
exposures,
as
recently
noted
by
the
NRC
(
2003)
publication
on
dioxin
exposures.
EPA
has
faced
a
similar
situation
previously
when
in
the
1970s
the
US
population
was
overexposed
to
lead.
In
that
case,
EPA
could
not,
and
still
does
not
estimate
an
RfD.
Nonetheless,
EPA
moved
to
identify
sources
and
exposures
of
lead,
and
eliminate
or
reduce
those
exposures.
A
similar
approach
is
called
for
in
the
case
of
TCDD
and
related
compounds.

All
of
these
areas
require
attention
in
the
new
503
rule,
along
with
evaluation
of
many
organic
chemicals
and
some
additional
metals.

Response
EPA
believes
that
the
elements
(
human
health
benchmarks,
pathways
of
exposure,
conceptual
site
models,
definition
of
the
highly
exposed
individual
(
HEI),
default
values
used
in
the
model
equations)
of
Part
503
risk
assessments
are
appropriately
conservative
to
protect
public
health
from
pollutants
in
sewage
sludge
with
an
adequate
margin
of
safety.

For
the
Round
One
pollutants,
an
individual
exposure
pathway
was
the
predominant
exposure
pathway
for
either
human
health
or
ecological
effects.
Summing
all
exposure
pathways
would
have
made
little
difference
on
EPA's
overall
risk
characterization
for
these
metallic
pollutants.
For
the
risk
assessment
that
was
utilized
on
dioxins
in
Round
Two
of
the
Part
503
Standards,
dioxin
exposure
to
the
HEI
for
individual
exposure
pathways
was
summed.

The
human
health
benchmarks
chosen
from
IRIS
or
OPP
take
into
full
consideration
sensitive
life
stages
of
humans
such
as
the
fetus
and
infants.
Please
see
also
EPA
responses
to
Comment
Log
No.
51
of
this
section.

With
respect
to
the
comments
on
dioxins,
see
68
Fed.
Reg.
61084
published
on
October
24,
2003,
which
announced
that
the
Agency
would
not
be
regulating
dioxins
in
land
applied
sewage
sludge.

Municipal
Wastewater
Treatment
Plants
EPA
Log
#
14:
Metro
Wastewater
Reclamation
District
Comment
The
Metro
District
supports
EPA's
plans
to
reassess
pollutant
exposure
pathways
and
risk
calculations.
Any
reevaluation
of
the
pollutant
limitations
included
in
the
current
Part
503
regulations
should
involve
the
most
current
exposure
and
toxicity
information.
The
same
procedures
should
be
applied
in
the
evaluation
of
any
additional
pollutants
selected
through
the
USEPA,
2003d
46
targeted
survey
evaluation
process.
The
District
encourages
the
EPA
not
to
rely
too
heavily
on
the
probabilistic
or
computer
modeling
approaches
in
the
risk
assessment
process.
To
be
useful,
modeling
results
require
some
type
of
verification
or
validation.
Verification
of
potential
adverse
effects
of
trace
amounts
of
pollutants
to
human
health
or
the
environment
can
take
years,
if
not
decades,
of
data
collection.
However,
when
coupled
with
the
more
traditional
deterministic
approach,
modeling
results
can
be
a
useful
screening
tool
to
support
findings
related
to
potential
adverse
impacts.

One
of
the
most
challenging
recommendations
of
the
NRC
report
concerns
potential
effects
of
biosolids
on
human
health.
The
NRC
has
recommended
that
EPA
conduct
comprehensive
studies
to
determine
if
land
application
of
biosolids
has
affected
biosolids
workers
or
nearby
residents.
The
Metro
District
agrees
with
the
NRC
and
EPA
that
comprehensive
epidemiological
studies
are
complex,
time
consuming,
and
require
substantial
funding.
EPA
has
proposed
a
strategy
that
focuses
on
short­
term,
focused
human
health
studies
that
could
provide
insight
into
whether
or
not
longer­
term
epidemiological
human
health
studies
are
warranted.
The
District
agrees
with
this
approach.
Short­
term
studies,
coupled
with
development
of
new
and
improved
analytical
testing
methods,
can
provide
important
first
phase
information
to
determine
if
more
in­
depth
epidemiological
studies
are
needed.
Improved
research
methods,
especially
for
recovery
of
pathogens
from
wind­
blown
soil/
biosolids
mixtures,
would
be
crucial
to
the
success
of
any
epidemiological
studies
that
attempt
to
correlate
the
presence
of
pathogenic
microorganisms
in
biosolids
with
suspected
diseases
in
humans
or
animals.

Response
EPA
agrees
with
these
comments.

EPA
Log
#
47:
Miami­
Dade
County
Water
and
Sewer
Department
(
MDWASD)

Comment
Evaluating
the
State
of
Science
and
the
Risk
Assessment
methodologies
is
also
very
important.
MDWASD
agrees
with
conducting
further
research
in
order
to
review
the
Risk
Assessment
methodologies.
We
support
the
in
depth
studies
and
review
being
conducted
by
the
WERF
and
other
research
organizations.
Throughout
this
research
and
review
process,
it
is
very
important
to
involve
the
Stakeholders.

MDWASD
commends
the
EPA
for
recognizing
the
need
for
further
review
and
studies
prior
to
changing
the
existing
regulations.

Response
EPA
agrees
with
these
comments.

Land
Application
Company
EPA
Log
#
26:
Synagro
Technologies,
Inc.

Comment
USE
IMPROVED
RISK
ASSESSMENT
METHODS
TO
ESTABLISH
BETTER
STANDARDS
FOR
CHEMICALS
AND
PATHOGENS.
USEPA,
2003d
47
State­
of­
the­
Art
Chemical
Risk
Assessment
The
expert
panel
correctly
pointed
out
that
advances
in
risk
assessment
methods
have
occurred
in
the
decade
since
the
Part
503
Round
I
regulations
were
promulgated.
As
expected,
such
advances
have
been
achieved
by
the
research
initiatives
undertaken
by
the
proper
branches
of
EPA.
The
Office
of
Water
(
OW)
is
a
"
consumer­
user"
of
these
methods,
not
a
"
developer"
of
such
methods.
That
is
why
any
effort
undertaken
by
OW
should
first
be
to
examine
the
state­
of­
the­
art
already
advanced
within
the
Agency.

A
key
example
is
the
new
probabilistic
risk
assessment
for
dioxin
and
dioxin­
like
substances
in
the
Part
503
Round
II
regulation
Notice
of
Data
Availability
(
NODA)
published
by
EPA
in
June
2002.
The
July
2002
release
of
the
Report
and
the
NODA
appearing
in
the
Federal
Register
in
June
2002
were
so
close
in
timing
that
the
expert
panel
did
not
have
the
benefit
of
reviewing
how
one
of
their
recommendations
(
conduct
a
modern
chemical
risk
assessment
for
land
applied
biosolids)
was
already
in
process.
EPA
should
seriously
consider
that
among
the
persistent,
bioaccumulative
toxics
(
PBT)
of
interest,
dioxin
and
dioxin­
like
compounds
are
domestically
and
internationally
considered
t
he
most
important
potential
health
threats
to
the
general
population.
Since
the
NODA
characterized
the
threat
from
these
highly
toxic
substances
as
both
low
and
remote,
using
unrealistically
conservative
and
exaggerated
risk
assumptions,
it
is
questionable
why
the
Agency
would
devote
significant
resources
to
investigate
chemicals
of
lower
human
toxicity.
EPA
should
consider
the
following
factors
in
deciding
how
much
effort
should
go
into
developing
new
chemical
risk
assessments.

°
Some
elements
of
the
Report
are
most
properly
handled
by
ORD/
NCEA
on
a
chemical­
specific
basis.
Some
of
the
recommendations
regarding
updating
the
503
Rule
risk
assessment
are
being
made
by
NCEA
as
it
conducts
its
periodic
reviews
of
IRIS.
OW
should
utilize
work
done
by
NCEA
and
should
not
be
responsible
for
risk
assessment
developments
in
this
area.

°
There
may
not
be
significant
gains
in
re­
calculating
risks.
For
example,
a
re­
calculation
of
the
arsenic
limit
using
currently
available
risk
assessment
methodology
yields
a
result
of
46
ppm
compared
to
41
ppm
in
the
503
Rule.
This
difference
is
too
small
to
be
significant.

°
EPA
has
developed
risk
assessment
technology
in
other
programs
that
can
be
used
with
little
modification
to
evaluate
new
chemicals
or
re­
evaluate
old
chemicals
found
in
biosolids.
EPA's
1998
Methodology
for
Assessing
Health
Risks
Associated
with
Multiple
Pathways
of
Exposure
to
Combustor
Emissions
(
EPA
600/
R­
98/
137)
("
Combustion
Guidance"),
for
example,
can
be
readily
adapted
to
assess
biosolids
risks
for
a
variety
of
pathways
and
receptors.
Since
this
methodology
has
already
been
through
extensive
peer
review
and
public
comment,
it
should
be
readily
acceptable
to
both
the
regulated
community
and
the
public.

°
Risk
assessments
should
be
focused.
Many
chemicals
do
not
need
to
be
evaluated
in
a
risk
assessment
for
a
variety
of
reasons:
o
Concentrations
are
too
low­
for
example,
cadmium
concentrations
have
dropped
significantly
due
to
operation
of
pretreatment
programs.
Current
cadmium
concentrations
in
biosolids
are
well
below
Soil
Screening
Levels
for
ingestion
by
either
residents
or
outdoor
workers;
thus
it
is
USEPA,
2003d
48
unlikely
that
cadmium
associated
with
biosolids
would
present
an
unacceptable
risk.
Screening
tools
such
as
SSLs
should
be
used
to
eliminate
chemicals
as
appropriate.
o
Many
chemicals
are
too
biodegradable
to
be
of
significance
in
biosolids.
For
example,
alkylphenols
degrade
so
rapidly
in
biosolids
that
a
risk
assessment
would
likely
not
be
meaningful,
especially
in
the
contingent
management
context
where
setbacks,
use
and
access
restrictions
are
required.
o
New
or
emerging
chemicals
can
be
dealt
with
using
focused
risk
assessments
in
a
rapid
and
cost­
effective
fashion.
For
example,
a
risk
assessment
of
PBDE's
using
readily
available
analytical
data
was
conducted
in
less
than
two
person­
weeks
using
existing
risk
assessment
technology.
This
risk
assessment
was
conducted
using
minor
modifications
to
the
Combustion
Guidance
in
addition
to
existing
reference
doses
from
IRIS
and
physicochemical
properties
readily
available
in
the
scientific
literature.

The
NAS/
NRC
report
recommended
EPA
use
improved
risk
assessment
technologies.
EPA
plans
to
reassess
its
risk
assessment
methodologies
and
apply
new
methodologies
to
key
pollutants
and
pathways
that
are
likely
to
be
of
greatest
concern
or
where
new
scientific
information
has
the
greatest
impact.

°
EPA's
definitions
of
stakeholders
in
this
section
appear
to
exclude
industry.

°
EPA
refers
to
"
state
of
the
science"
and
"
most
up
to
date"
scientific
information
and
risk
assessment
technologies.
EPA
should
only
rely
on
peer
reviewed
and
generally
accepted
information
and
methodologies
and
not
innovative
techniques
that
may
not
be
reliable.
EPA
is
required
to
ensure
that
any
results
of
a
new
or
"
developing"
risk
assessment
has
full
peer
review
in
order
to
comply
with
the
Data
Quality
Act.

°
There
were
a
lot
of
problems
with
the
Round
Two
risk
assessment
that
should
be
mentioned.

°
EPA
should
make
biosolids
risk
assessments
consistent
with
other
risk
assessments
performed
throughout
the
Agency.

Response
Please
see
EPA's
response
to
Comment
Log
Nos.
51
and
43­
Peter
Defur
in
this
section
with
respect
to
chemical
pollutant
risk
assessments.
With
respect
to
pathogen
risk
assessments,
please
see
the
EPA
response
to
Comment
Log
No.
37
in
this
section.

State­
of­
the­
Art
Quantitative
Microbiological
Risk
Assessments
EPA
should
consider
the
following
factors
in
regard
to
pathogen
risk
assessment
efforts.

°
EPA
should
not
undertake
quantitative
microbiological
risk
assessments
(
QMRA)
unless
it
has
developed
and
published
a
peer­
reviewed
guidance
document
that
has
SAB
approval.
Anything
less
would
not
comply
with
the
Data
Quality
Act.

°
Quantitative
microbial
risk
assessment
(
QMRA)
is
a
relatively
new
tool
that
has
neither
a
history
of
use
in
rule
making
nor
the
degree
of
validation
necessary
to
ensure
its
reliability.
The
elements
USEPA,
2003d
49
of
a
QMRA
are
similar
to
those
of
a
chemical
risk
assessment.
QMRA
requires
problem
formulation,
exposure
analysis,
pathogen
occurrence
analysis,
evaluation
of
potential
health
effects
and
the
dose­
response
relationship
and
the
combination
of
this
information
in
a
risk
characterization.

°
The
development
of
the
Part
503
Rule,
Round
I,
used
pathogen
risk
assessment
data
although
not
in
the
current
QMRA
framework.
For
example,
pathogen
identification,
enumeration,
treatability,
virulence,
and
persistence
were
all
studied
by
EPA.
The
Part
503
rule
requires
a
high
level
of
pathogen
reduction
(
based
upon
a
2­
log
reduction
or
at
least
99%
removal)
coupled
with
site
restrictions,
which
are
based
upon
the
worse
case
survival
times
for
pathogens.
This
is
risk
assessment
and
is
more
than
adequate
to
protect
human
health
as
proven
by
the
absence
of
documented
health
effects
among
biosolids
workers,
wastewater
treatment
plant
operators
and
the
general
public.

°
The
Report
did
not
consider
readily
available
information
regarding
pathogen
risk
assessments.
For
example,
EPA's
1995.
Pathogen
Risk
Assessment
Methodology
for
Municipal
Sewage
Sludge
Landfilling
and
Surface
Disposal
(
EPA/
600/
R­
95/
016)
was
not
cited
in
the
report,
nor
was
Bitton's
Wastewater
Microbiology.

°
The
large
amount
of
available
information,
including
that
not
considered
in
the
Report,
is
probably
sufficient
to
put
into
the
current
QMRA
framework
in
a
contingent
management
context.

°
Extreme
caution
must
be
taken
in
using
many
studies
of
environmental
pathogens.
Existing
pathogen
measurement
science
is
not
as
reliable
as
chemical
analyses.
Problems
exist
with
detection
limits,
species
identification,
quality
assurance/
quality
cont
rol,
and
background
levels
which
all
need
to
be
considered.

The
NAS/
NRC
report
recommended
that
EPA
develop
and
standardize
methods
for
measuring
pathogens
and
emerging
chemicals
in
biosolids
and
bioaerosols.
EPA
already
has
ongoing
and
planned
research
in
these
areas.

°
Fourier
Transform
Infrared
(
FTIR)
spectrometry
techniques
should
be
validated
and
quality
assured
prior
to
use
at
land
application
sites.

°
EPA
needs
to
carefully
consider
contribution
of
naturally
occurring
background
to
airborne
microorganism
concentrations.
Pattern
recognition
techniques
such
as
principal
components
analysis
or
cluster
analysis
should
be
evaluated
for
this
purpose.

°
EPA
should
consider
methods
developed
by
consensus
organizations
such
as
"
Standard
Methods"
and
ASTM
standard
methods.

Response
With
respect
to
pathogen
risk
assessments,
please
see
the
EPA
response
to
Comment
Log
No.
37
in
this
section.
USEPA,
2003d
50
Chemical
and
Pathogen
Risk
Assessment
and
Contingent
Management
The
NAS/
NRC
panel
recommendations
are
seriously
flawed
because
they
viewed
biosolids
land
application
primarily
from
a
theoretical
perspective,
and
they
essentially
ignored
that
the
practice
is
already
heavily
regulated.
EPA
needs
to
set
the
record
straight
on
this
and
make
the
point
that
the
entire
regulatory
framework
of
biosolids
management
needs
to
be
considered
before
any
additional
risk
or
health
studies
are
undertaken.
The
practice
of
biosolids
land
application
is
a
contingent
management
activity,
meaning,
in
part,
that
limits,
restrictions
and
prohibitions
apply
via
federal
and
state/
local
regulation.
Any
realistic
chemical
or
pathogen
risk
assessment
should
take
these
contingent
management
requirements
into
consideration
as
inputs
into
the
model.

°
Biosolids
beneficial
recycling
is
not
an
"
unregulated"
activity.
The
safe
beneficial
use
of
biosolids
is
contingent
on
application
of
a
comprehensive
framework
including
regulations
contained
in
the
Clean
Water
Act
(
CWA),
Resource
Conservation
and
Recovery
Act
(
RCRA),
Federal
Insecticide
Fungicide
and
Rodenticide
Act/
Food
Quality
Protection
Act
(
FIFRA/
FQPA),
Toxic
Substances
Control
Act
(
TSCA),
state
and
local
statutes
and
regulations,
and
industry
practices
ranging
from
the
Responsible
Care
of
the
chemical
industry
to
the
management
practices
of
the
National
Biosolids
Partnership.
It
is
not
possible
to
fully
understand
the
environmental
context
of
biosolids
generation
and
use
without
considering
this
entire
framework.

°
Although
risk
assessments
and
health
studies
are
important,
they
are
only
one
component
of
biosolids
management
t
hat
ensures
health
and
safety
of
land
application.
The
NAS/
NRC
Report
did
not
consider
the
other
components,
but
rather
only
focused
on
risk
assessments
and
health
studies.
Other
significant
components
include:

o
Technology­
based
standards.
Technology­
based
standards
for
pathogen
control
are
a
keystone
of
biosolids
regulation.
This
topic
was
given
short
shrift
in
the
Report
(
pp
202­
205),
despite
the
large
amount
of
literature
and
operating
data
on
this
subject.
Technology­
based
standards
are
a
viable
alternative
to
risk­
based
standards.
Other
environmental
regulatory
programs
(
e.
g.
MACT
under
the
Clean
Air
Act)
function
well
using
health­
protective
technology­
based
standards
while
risk
assessments
are
being
developed.
The
parallel
between
the
CAA
MACT
rule
and
the
503
Rule
should
be
further
explored
and
utilized
should
additional
biosolids
risk
assessment
be
required.
It
is
possible
that
additional
biosolids
risk
assessment
may
be
useful
in
the
limited
context
of
demonstrating
t
he
safety
of
t
he
existing
technology­
based
standards
of
the
503
Rule.
o
Management
Practices
include
the
Code
of
Good
Practice,
National
Manual
of
Good
Practice,
EMS
Guidance,
and
EMS
verification.
By
encouraging
the
use
of
management
practices,
a
degree
of
environmental
protection
over
and
above
that
afforded
by
regulatory
compliance
may
be
attained.
o
Institutional
controls
include
the
land­
use
restrictions
in
the
503
Rule
in
addition
to
state
and
local
controls
such
as
setbacks.
Both
of
these
are
designed
to
limit
exposure
pathways
or
to
allow
time
for
both
chemicals
and
pathogens
to
be
detoxified
by
natural
attenuation
before
exposure
might
occur.

°
Not
only
are
these
elements
of
contingent
management
important
for
the
overall
assurance
of
safe
biosolids
practices,
but
they
should
also
be
incorporated
into
any
risk
assessment
that
may
be
USEPA,
2003d
51
performed
in
the
future.
For
example,
setbacks,
land­
use
restrictions,
and
sediment
control
best
management
practices
that
are
currently
required
should
be
used
as
inputs
to
risk
assessment
scenarios.

The
NAS/
NRC
report
recommended
that
EPA
evaluate
measurement
and
risk
assessment
techniques
for
removing
perceived
uncertainties
regarding
pathogens.
EPA
is
proposing
pathogen
research
in
several
areas.

°
Technology/
management­
based
approaches
are
still
valid
and
shouldn't
be
abandoned.

°
The
relationship
between
odor
and
health
effects
is
not
established,
is
controversial
and
affects
federal
agencies
other
than
EPA.
It
should
be
dealt
with
elsewhere.

°
The
PEC
should
be
the
main
instrument
for
dealing
with
pathogens.

°
EPA
should
probably
take
no
action
regarding
pathogens
until
the
WERF
and
NSF­
WQC
research
is
finished.

°
QMRA
cuts
across
federal
agencies.
For
example,
FDA
and
CDC
may
rely
on
QMRA
for
activities
totally
unrelated
to
biosolids.
QMRA
is
probably
best
dealt
with
via
an
interagency
effort
rather
than
in
the
context
of
biosolids
research.

Response
EPA
agrees
in
general
with
these
comments.
The
efficacy
of
sewage
sludge
land
application
regulations
is
based
to
a
large
extent
on
the
extent
of
overlapping
regulation
at
the
Federal,
State,
and
local
levels
and
the
resultant
overlapping
regulatory
oversight
of
sewage
sludge
land
application
projects.

Association
EPA
Log
#
30:
Tri­
TAC
Comment
Risk
Assessments
Tri­
TAC
supports
EPA's
plans
to
address
the
potential
health
hazards
and
exposures
associated
with
land
application
of
biosolids
using
state­
of­
the­
science
risk
assessment
approaches.
Tri­
TAC
strongly
encourages
EPA
to
consider
how
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.

Tri­
TAC
understands
that
EPA
plans
to
"
use
the
Round
Two
risk
assessment
approach
[
a
probabilistic
approach]
as
a
starting
point
for
evaluating
the
NRC's
recommendations,
including
the
use
of
the
reasonable
maximum
exposed
(
RME)
individual"
for
improving
risk
assessments
in
future
rulemakings.
Tri­
TAC
cautions
EPA
to
ensure
that
the
probabilistic
approach
is
consistent
with
EPA
risk
assessment
policy
and
sufficiently
validated
to
support
future
regulatory
decisions.
EPA
should
consider
whether
the
probabilistic
approach
should
be
used
only
as
a
screening
tool
USEPA,
2003d
52
and
whether
it
may
need
to
be
coupled
with
the
more
traditional
deterministic
approach
in
some
applications.

Tri­
TAC
further
understands
that
the
EPA's
use
of
a
risk
assessment
framework
or
paradigm
to
provide
a
focused
reassessment
of
certain
previously
addressed
pollutant
risks,
exposure
pathways
and
risk
assessment
approaches,
as
well
as
an
assessment
of
pollutants
which
have
not
been
previously
evaluated,
may
result
in
updates
to
the
Round
1
risk
assessment
models
and
reevaluations
of
selected
pollutants.
Tri­
TAC
would
support
any
such
reevaluations
of,
or
updates
to,
the
"
science"
associated
with
these
earlier
rulemakings
to
the
extent
that
EPA's
problem
formulation
process
identifies
them
as
priority
areas.

Tri­
TAC
suggests
that
EPA's
efforts
to
understand
the
potential
risks
associated
with
biosolids
focus
primarily
on
those
areas
where
there
are
perceived
weaknesses
in
the
current
regulations,
specifically
pathogens
in
biosolids
and
bioaerosols.

Response
See
EPA
responses
to
Comment
Log
Nos.
51
and
43­
Peter
Defur.

EPA
Log
#
27:
California
Farm
Bureau
Federation
Comment
The
USEPA
must
reevaluate
its
land
application
assumptions;
"
real
world"
biosolids
application
rates
greatly
exceed
what
the
USEPA
presumed
when
it
developed
its
regulations.

In
its
risk
assessment,
the
USEPA
assumed
that
the
typical
annual
sludge
application
rate
for
agricultural
land
based
on
crop
nutrient
requirements
would
be
7
metric
tons/
hectare
(
approximately
3
tons/
acre).
24
As
the
D.
C.
Circuit
Court
of
Appeals,
in
Leather
Industries
of
America,
Inc.
v.
Environmental
Protection
Agency,
et
al.,
40
F.
3d
392,
396
(
1994),
described
it,
the
USEPA
developed
the
eight
(
formerly
ten)
regulated
metals
concentration
limits:

"
By
applying
certain
conservative
assumptions"
about
the
amount
of
sludge
that
would
be
applied
to
a
given
area
of
land,
the
EPA
"
backcalculated"
from
the
total
pollutant
limits
in
a
given
area
of
land
to
a
permissible
sludge
pollutant
concentration
per
load.
58
Fed.
Reg.
9317.
The
"
backcalculation"
provides
the
EPA
a
means
of
converting
the
cumulative
pollutant
limit
into
a
concentration
cap
for
the
pollutant
in
any
given
load
of
sludge.
The
model
assumes
a
total
amount
of
sludge
that
will
be
applied
to
a
given
hectare
of
land
based
on
an
assumed
yearly
application
rate
and
assumed
duration
of
application.
The
EPA
assumed
that
ten
metric
tons
of
sludge
would
be
applied
annually
to
a
hectare
of
land
for100
years.
This
converts
into
an
assumption
that,
in
total,
1000
metric
tons
of
sludge
will
be
applied
to
a
given
hectare
of
land.
Based
on
(
1)
this
total
amount
of
sludge
that
the
EPA
assumed
would
accumulate
on
an
area
of
land,
and
(
2)
the
total
amount
of
pollutant
that
the
EPA
had
determined
could
safely
accumulate
on
an
area
of
land,
the
EPA
calculated
pollutant/
sludge,
the
permissible
concentration
of
pollutant
in
any
application
of
sludge.
(
internal
citations
omitted)

Converting
units
from
metric
tons/
hectare
to
tons/
acre,
it
is
evident
the
USEPA,
in
developing
its
metals
concentration
limits,
assumed:
(
1)
that
annual
sewage
sludge
applications
at
a
particular
USEPA,
2003d
53
site
would
be
limited
to
approximately
4.4
tons/
acre;
and
(
2)
that
the
total
lifetime
accumulation
of
sewage
sludge
at
a
particular
site
would
not
exceed
440
tons/
acre.
Yet,
in
California,
annual
biosolids
applications
may
reach
10­
40
dry
tons/
acre.
25
On
this
basis,
use
of
the
USEPA's
metals
concentration
limits
may
underestimate
metals
accumulation
rates
by
a
factor
of
ten
(
10)
or
more.

Further,
application
rates
of
10­
40
tons/
acre
would
mean
that
the
USEPA's
assumed
lifetime
accumulation
of
sewage
sludge
at
a
particular
site
could
be
reached
within
10­
11
years,
not
100
years.
This
negates
claims
that
we
need
not
worry
about
the
possible
harmful
buildup
of
metals
concentrations
in
soils
at
application
sites,
since
it
may
take
only
10
years
(
a
very
realistic
time
frame)
for
typical
applications
to
cause
the
total
accumulation
of
sewage
sludge
at
a
particular
site
to
exceed
the
maximum
amount
the
USEPA
assumed
would
be
deposited
there.
26
Considering
that
farmers
generally
intend
to
continue
farming
for
many
years,
and
pass
their
farms
on
to
their
children,
this
is
a
frightening
prospect
that
justifies
the
adoption
of
more
conservative
metals
concentration
limits
and
application
rates.

Response
See
EPA
responses
to
Comment
Log
Nos.
51
and
43.

EPA
Log
#
50:
Water
Environment
Federation
(
WEF)

Comment
Context
and
Risk
Communication
 
To
some,
the
existence
of
detailed
studies
and
risk
assessments
of
biosolids
imply
that
they
are
dangerous;
to
others,
"
exposure
equals
risk."
To
address
these
erroneous
reactions,
EPA
needs
to
follow
through
on
its
commitment
to
improve
risk
communication.
One
way
for
EPA
to
accomplish
this
goal
may
be
to
provide
a
context
for
the
information
that
will
aid
people's
understanding.
For
example,
EPA
should
consider
presenting
biosolids
information
as
a
comparison
between
biosolids
and
other
materials
used
in
a
similar
manner,
like
manures
or
chemical
fertilizers,
which
are
more
familiar
to
the
public.

C.
Risk
Assessment
WEF
endorses
the
approach
EPA
proposed,
most
specifically
the
reassessment
of
previously
evaluated
pollutants
(
in
light
of
new
data
and
approaches),
the
assessment
of
new
pollutants
based
upon
state­
of­
the­
art
approaches,
the
inclusion
of
stakeholders
in
the
risk
assessment
process,
and
collaboration
with
USDA
and
others.
The
two­
step
process
outlined
by
EPA
that
will
ultimately
result
in
a
prioritized
list
for
risk
assessment
activities
is
logical
and
should
result
in
maximum
value
to
the
public.

Response
See
EPA
responses
to
Comment
Log
Nos.
51
and
43.

EPA
Log
#
46:
Association
of
Metropolitan
Sewerage
Agencies
(
AMSA)

Comment
Risk
Assessments
AMSA
supports
EPA's
plans
to
address
the
potential
health
hazards
and
exposures
associated
with
land
application
of
biosolids
using
state­
of­
the­
science
risk
assessment
approaches.
AMSA
strongly
encourages
the
Agency
to
consider
how
representative
stakeholders
could
be
included
in
USEPA,
2003d
54
the
risk
assessment
process
to
help
identify
exposure
pathways,
local
conditions
that
could
influence
exposure,
and
possible
adverse
health
outcomes.

AMSA
understands
that
EPA
plans
to
"
use
the
Round
Two
risk
assessment
approach
[
a
probabilistic
approach]
as
a
starting
point
for
evaluating
the
NRC's
recommendations,
including
the
use
of
the
reasonable
maximum
exposed
(
RME)
individual"
for
improving
risk
assessments
in
future
rulemakings.
AMSA
cautions
the
Agency
to
ensure
that
the
probabilistic
approach
is
consistent
with
Agency
risk
assessment
policy
and
sufficiently
validated
to
support
future
regulatory
decisions.
EPA
should
consider
whether
the
probabilistic
approach
should
be
used
only
as
a
screening
tool
and
whether
it
may
need
to
be
coupled
with
the
more
traditional
deterministic
approach
in
some
applications.

AMSA
further
understands
that
the
Agency's
use
of
a
risk
assessment
framework
or
paradigm
to
provide
a
focused
reassessment
of
certain
previously
addressed
pollutant
risks,
exposure
pathways
and
risk
assessment
approaches,
as
well
as
an
assessment
of
pollutants
which
have
not
been
previously
evaluated,
may
result
in
updates
to
the
Round
One
risk
assessment
models
and
reevaluations
of
selected
pollutants.
AMSA
would
support
any
such
reevaluations
of,
or
updates
to,
the
science
associated
with
these
earlier
rulemakings
to
the
extent
that
EPA's
problem
formulation
process
identifies
them
as
priority
areas.
AMSA
suggests
that
EPA's
efforts
to
understand
the
potential
risks
associated
with
biosolids
focus
primarily
on
those
areas
where
there
are
perceived
weaknesses
in
the
current
regulations,
specifically
pathogens
in
biosolids
and
bioaerosols.

Response
See
EPA
responses
to
Comment
Log
Nos.
51
and
43.

States
EPA
Log
#
48
and
39
(
duplicates):
Wisconsin
Department
of
Natural
Resources
Comment
10.
Section
VIII.
C.
Risk
Assessment
­
The
response
in
this
section
represents
a
reasonable
approach
assuming
the
actions
are
actually
taken
and
the
recommendations
are
fulfilled.
They
must
be
done.

Response
EPA
thanks
the
commenter
for
the
comments.
See
EPA
responses
to
Comment
Log
Nos.
51
and
43.

EPA
Log
#
59:
New
Jersey
Department
of
Environmental
Protection
(
NJDEP)

Comment
The
NRC
recommendations
included
reassessing
standards
for
chemicals
currently
in
the
Part
503
regulation.
Since
there
is
new
information
available,
the
Department
believes
that
it
would
be
prudent
to
perform
a
revised
multipathway
risk
assessment
with
particular
attention
paid
to
arsenic,
and
indirect
pathways
for
mercury.
Specifically,
the
Department
supports
the
NRC
recommendations
to
confirm
that
the
speciation
of
arsenic
and
mercury
in
biosolids
are
in
forms
USEPA,
2003d
55
that
are
less
toxic,
and
that
reduced
metal
bioavailability,
than
what
had
been
assumed
in
developing
the
current
standards,
in
biosolids­
amended
soils
is
very
likely.

Response
See
EPA
responses
to
Comment
Log
Nos.
51
and
43.
In
the
Round
one
Standards,
EPA
assumed
arsenic
was
in
the
most
prevalent
toxic
chemical
valence
state.
Analytical
data
indicate
that
methyl
mercury
is
an
insignificant
fraction
of
total
mercury
in
sewage
sludge.
The
Part
503
Round
one
numerical
standard
for
mercury
is
based
on
the
most
prevalent
and
toxic
form
of
mercury,
mercuric
(+
2).

TOPIC
D.
METHODS
DEVELOPMENT
Academia
EPA
Log
#
51:
Ellen
Z.
Harrison
Comment
EPA
is
"
considering
developing
and
validating
methods
for
measuring
bacteria
and
virusus."
This
is
a
critical
need.
In
reviewing
the
plans
for
the
PA
study,
it
became
clear
that
existing
methods
not
only
for
viruses
but
also
for
bacteria,
are
totally
inadequate.
Data
presented
to
the
group
showed
that
samples
tested
under
"
approved"
Colony
Forming
Unit
(
CFU)
methods
failed
to
detect
the
pathogens,
while
Most
Probable
Number
(
MPN)
methods
detected
them.
If
research
and
regulatory
decisions
are
based
only
on
currently
approved
methods,
we
are
clearing
failing
to
monitor
as
needed
and
we
may
be
failing
to
protect
the
public
health.
There
is
an
urgent
need
for
EPA
to
work
to
develop
and
validate
methods
for
detection
and
enumeration
of
bacteria
and
viruses
in
sludges,
soil,
water
and
air.

Response
Project
3
in
Section
VII
B
of
today's
Federal
Register
notice
describes
EPA's
program
for
improving
the
analytical
methods
for
Salmonella,
enteric
viruses,
Ascaris
ova
and
fecal
coliforms
in
sewage
sludge
within
the
next
three
years.
EPA
fully
agrees
with
the
commenter
on
the
importance
of
this
effort.

Citizens
EPA
Log
#
29:
Henry
J.
Staudinger
Comment
D.
EPA's
Methods
Development
Strategy
is
Not
Adequate.
NRC
Recommends
that
EPA
develop
standard
methods
for
measuring
pathogens
and
emerging
chemicals
in
biosolids
and
bioaerosols
to
better
conduct
and
interpret
future
risk
assessment.

EPA's
strategy
is
to
address
this
recommendation
through
studies
such
as
the
EPA/
USDA/
DEP
project
discussed
earlier.
However,
the
Pennsylvania
project
will
focus
only
on
a
limited
number
of
pollutants
and
was
not
designed
to
focus
on
pollutants
present
in
biosolids
likely
to
cause
adverse
health
complaints.
USEPA,
2003d
56
Response
Please
see
the
EPA
response
to
Comment
Log
No.
51
of
this
section.
In
addition,
please
see
Project
10
in
Section
VII
B
of
today's
Federal
Register
notice
entitled
Development
and
Application
of
Analytical
Methods
for
Detecting
Pharmaceutical
and
Personal
Care
Products
(
PPCPs)
in
Sewage
Sludge.

The
purpose
of
this
project
is
to
develop
and
apply
analytical
methodologies
for
detecting
pharmaceutical
and
personal
care
products
(
PPCPs)
in
sewage
sludge.
The
NRC
Report
specifically
identified
PPCPs
as
one
category
of
diverse
compounds
that
has
not
been
studied
in
sewage
sludge
and
that
is
especially
likely
to
be
present
in
domestic
sewage
sludge.
The
NRC
report
indicated
that
there
is
a
need
for
a
new
hazard
assessment
of
sewage
sludge
to
expand
the
suite
of
chemicals
evaluated.

In
FY
2004
through
FY
2005,
chemical
analysis
methods
developed
in­
house
previously
for
PPCPs
(
e.
g.,
antibiotics
and
musks)
would
be
adapted
for
sewage
sludge.
In
FY
2006,
EPA
may
finish
methods
development,
convert
them
to
40
CFR
Part
136
methodology,
and
publish
methodologies.
Subsequently,
the
methods
may
be
applied
to
a
limited
number
of
real­
world
samples
for
a
pilot­
scale
survey
of
PPCPs
in
sewage
sludge.

With
respect
to
other
emerging
chemicals,
EPA
has
developed
analytical
methods
for
certain
endocrine
disrupting
chemicals
(
EDC)
and
is
studying
the
fate
and
transport
of
these
EDCs
in
the
land
application
situation,
particularly
amounts
in
sewage
sludge,
degradation
following
application,
transport
down
the
soil
column,
and
runoff
into
surface
waters.
Current
studies
focus
on
the
fate
and
transport
of
the
specific
EDCs:
alkyl
phenol
ethoxylates
and
steroid
hormones.

EPA
Log
#
37:
David
A.
Burrows
Comment
On
page
17388
of
the
Federal
Register,
in
the
"
methods
development"
section,
is
stated
"
EPA
is
considering
developing
and
validating
analytical
methods
for
enteric
viruses
and
helminth
ova..."
These
viruses
and
ova
are
human
health
threats
and
this
work
should
be
done
now.

Response
Please
see
the
EPA
response
to
Comment
Log
No.
51
of
this
section.

EPA
Log
#
40:
Thomas
F.
Albert
Comment
Comment
#
21:
On
page
17388
in
the
section
"
2.
The
Agency's
Response
to
Methods
Development"
there
again
seems
to
be
mention
of
the
"
5
site
sludge
study."
Is
this
the
cooperative
study
in
PA
by
the
EPA/
USDA/
PA
DEP?

Comment
#
22:
On
page
17388
in
the
"
methods
development"
section
is
stated
"
EPA
is
considering
developing
and
validating
analytical
methods
for
enteric
viruses
and
helminth
oval
 
.
"
Why
just
CONSIDER
this?
Why
not
DO
it?
Such
viruses
and
ova
are
health
threats,
what
health
benefit
is
there
by
waiting?
USEPA,
2003d
57
Response
Paragraph
one
of
these
comments:
Please
see
the
EPA
response
to
the
Comment
Topic
B
section
of
this
document.
Paragraph
two
of
these
comments:
Please
see
the
EPA
response
to
Comment
Log
No.
51
in
this
section.

EPA
Log
#
25:
Northumberland
Association
for
Progressive
Stewardship
(
NAPS)
Sewage
Sludge
Study
Group
Comment
D.
Methods
Development
Lines
757­
801.
We
are
also
pleased
that
EPA
plans
to
implement
the
NRC
recommendations
regarding
methods
development.
But
we
also
believe
that
methods
development
will
be
shallow
unless
adequate
resources
are
applied
to
the
survey,
exposure
and
risk
assessment
processes
mentioned
above.

Response
EPA
agrees
with
these
comments.

Environmental
Groups
EPA
Log
#
43:
Natural
Resources
Defense
Council
(
NRDC)

Comment
NRC
recommends
that
EPA
develop
and
standardize
methods
for
measuring
pathogens
and
developing
chemicals
in
biosolids
and
bioaerosals.
This
would
also
help
to
ensure
that
the
Agency's
management
practices
and
standards
are
reliable.
Specific
recommendations
include
using
improved
pathogen
detection
technology,
round­
robin
laboratory
testing,
mechanisms
for
incorporating
new
methodologies
into
the
verification
process,
and
measures
of
performance
that
can
be
easily
monitored.

Although
acknowledging
the
need
for
improving
exposure
assessment
methods
and
treatment
processes,
EPA
proposes
to
take
no
action
beyond
existing
studies
and
projects.
Undoubtedly,
these
ongoing
efforts
are
important
to
the
methods
development
process,
but
fall
far
short
of
what
NRC
deems
necessary.
Completely
absent
from
EPA's
self­
described
plans
for
methods
development
is
any
concrete
plan
to
standardize
or
validate
existing
methods
or
to
verify
that
the
Agency's
management
practices
and
standards
are
reliable.
Instead
of
developing
a
system­
wide
approach
to
improving
and
standardizing
methodology,
EPA
vaguely
references
prospective
projects
that,
although
beneficial,
would
continue
EPA's
piecemeal
approach
to
biosolids
methods
development.

Response
Please
see
EPA's
response
to
Comment
Log
Nos.
51
and
29
of
this
section.

Municipal
Wastewater
Treatment
Plants
EPA
Log
#
14:
Metro
Wastewater
Reclamation
District
Comment
In
response
to
the
NRC
report's
recommendation
to
develop
new
and
improved
analytical
test
methods,
the
EPA
has
proposed
a
robust
plan
to
evaluate
analytical
methods
for
USEPA,
2003d
58
pathogens
and
chemicals
associated
with
biosolids.
The
Metro
District
endorses
this
plan
as
a
prudent,
measured
approach
to
developing
better
test
methods.
The
District
agrees
that
improved,
standardized
tests
are
needed
for
pathogens
in
biosolids.
Valid
risk
assessments
are
predicated
upon
the
availability
of
accurate
data.
In
addition,
studies
on
any
cause­
effect
relationships
related
to
biosolids,
land
application
sites,
and
community
impacts
require
improved
analytical
methods
to
identify
pollutants
and
microorganisms
in
soil,
water,
and
air.

The
Metro
District
suggests
that
EPA
consider
expanding
its
review
to
include
available
but
unpublished
data
on
pollutant
concentrations
at
land
application
sites
managed
by
private
contractors
or
wastewater
treatment
agencies.
For
example,
such
entities
may
have
produced
data
from
"
in­
house"
studies.
This
information
could
be
used
to
meet
EPA's
goals
related
to
validation
of
the
management
restrictions
in
the
current
Part
503
regulations.

Response
EPA
thanks
the
commenter
for
the
comments
in
paragraph
one.
With
respect
to
paragraph
two,
EPA
will
utilize
only
those
data
that
meet
the
criteria
contained
in
EPA's
Data
Quality
Guidelines.

Association
EPA
Log
#
30:
Tri­
TAC
Comment
Methods
Development
In
response
to
the
NRC
Report's
recommendation
to
develop
new
and
improved
analytical
test
methods,
EPA
has
outlined
its
ongoing
and
planned
methods
development
activities,
indicating
that
it
plans
to
focus
resources
on
pathogens
and
chemicals
associated
with
biosolids.
Tri­
TAC
agrees
with
the
NRC's
recommendation
and
EPA's
assessment
that
validated
analytical
methods
are
necessary,
for
example,
to
support
exposure
assessments,
for
determining
the
reliability
of
treatment
processes,
assaying
pathogens
and
chemicals
in
raw
and
treated
biosolids,
and
incident
follow­
up.
Valid
risk
assessments
are
predicated
upon
the
availability
of
accurate
data.
Studies
on
any
cause­
effect
relationships
related
to
biosolids,
land
application
sites,
and
community
impacts
require
improved
analytical
methods
to
identify
pollutants
and
microorganisms
in
soil,
water,
and
air.

EPA
describes
recently
initiated
EPA
methods
development
work
including
field
studies
at
five
biosolids
production
and
application
sites.
EPA
also
describes
ongoing
field
studies
at
animal
manure
land
application
sites,
composting
sites,
and
concentrated
animal
feeding
operations,
which
are
measuring
pathogens,
toxic
organic
compounds,
odorants
and
particulates.
In
addition
to
using
these
field
studies
on
non­
biosolids
land
application
sites
for
methods
development,
Tri­
TAC
encourages
EPA
to
use
the
information
collected
from
these
studies
to
assess
the
relative
risk
posed
by
biosolids
land
application
and
to
assess
the
need
for
regulations
on
these
other
amendments
in
order
to
protect
human
health
or
the
environment.

Response
EPA
agrees
with
these
comments.
USEPA,
2003d
59
EPA
Log
#
50:
Water
Environment
Federation
(
WEF)

Comment
D.
Methods
Development
WEF
agrees
that
standardized
protocols
for
the
measurement
of
pathogens,
odorants,
and
emerging
chemicals
must
be
performed.
At
present,
it
seems
that
it
may
be
a
long
time
before
basic
methods
for
the
analyses
of
some
pathogens
are
available,
let
alone
developed
to
the
point
that
reproducible,
practical
methods
are
accessible
to
most
laboratories.
To
address
potential
concerns
in
the
area
of
pathogen
analysis,
WEF
agrees
with
the
NRC's
recommendation
that
there
should
be
concurrent
emphasis
on
confirming
the
appropriateness
of
existing
indicator
organisms
or
identifying
new
ones
(
clostridium,
for
example).
The
Federation
encourages
EPA
to
involve
WEF
and
other
clean
water
professionals
in
the
process
to
make
sure
the
required
methods
for
measurement
can
be
reasonably
achieved.

Response
EPA
agrees
with
these
comments.
Please
see
the
EPA
response
to
Comment
Log
No.
51.
EPA
will
involve
all
stakeholders
(
the
general
public,
State
and
local
agencies,
industry
and
private
groups)
as
it
executes
its
action
plan
in
response
to
the
NRC
recommendations.

EPA
Log
#
46:
Association
of
Metropolitan
Sewerage
Agencies
(
AMSA)

Comment
Methods
Development
In
response
to
the
NRC
Report's
recommendation
to
develop
new
and
improved
analytical
test
methods,
EPA
has
outlined
its
ongoing
and
planned
methods
development
activities.
AMSA
agrees
with
the
NRC's
recommendation
and
EPA's
assessment
that
validated
analytical
methods
are
necessary,
for
example,
to
support
exposure
assessments,
for
determining
the
reliability
of
treatment
processes,
assaying
pathogens
and
chemicals
in
raw
and
treated
biosolids,
and
incident
follow­
up.

EPA
describes
recently
initiated
EPA
methods
development
work
including
field
studies
at
five
biosolids
production
and
application
sites.
EPA
also
describes
ongoing
field
studies
at
animal
manure
land
application
sites,
composting
sites,
and
concentrated
animal
feeding
operations,
which
are
measuring
pathogens,
toxic
organic
compounds,
odorants
and
particulates.
In
addition
to
using
these
field
studies
on
non­
biosolids
land
application
sites
for
methods
development,
AMSA
encourages
EPA
to
use
the
information
collected
from
these
studies
to
assess
the
relative
risk
posed
by
biosolids.

Response
EPA
agrees
with
these
comments.

Counties
EPA
Log
#
28:
Solano
County
Department
of
Environmental
Management
Comment
2.
Sampling
Methods
and
Protocols
The
Solano
County
DEM
recommends
that
the
EPA
pursue
developing
protocols
for
sampling
of
biosolids
at
different
treatment
plants
and
within
the
same
treatment
plant
over
time,
based
on
USEPA,
2003d
60
inflow
sources
to
the
treatment
plant
and
the
treatment
processes
used
at
the
plant.
The
intent
of
such
protocols
should
be
to
provide
a
level
of
credibility
to
the
quality
control
sampling
results
so
that
the
chemical,
pathogen,
and
nutrient
content
found
by
the
sampling
can
be
assured
not
to
be
exceeded
during
periods
that
the
biosolids
are
not
sampled.

Response
Responded
to
in
Section
One
(
Survey)
of
this
document.

States
EPA
Log
#
48
and
39
(
duplicates):
Wisconsin
Department
of
Natural
Resources
Comment11.
Section
VIII.
D.
Methods
Development
­
Planned
Method
Development
Activities
­
It
is
stated
that
EPA
is
"
considering"
developing
and
validating
analytical
methods
for
enteric
viruses
and
helminth
ova.
This
work
must
be
done
because
these
pathogens
are
regulated
under
the
federal
standards.
It
is
impractical
to
implement
a
regulation
when
methods
for
analyzing
limited
constituents
does
not
exist.
Funding
must
be
provided
to
complete
this
work
(
see
also
comment
6
and
7).

Response
EPA
agrees
with
these
comments.
Please
see
EPA's
response
to
Comment
Log
No.
51
in
this
section
of
the
document.
USEPA,
2003d
61
TOPIC
E.
PATHOGENS
Citizens
EPA
Log
#
6:
Edward
McGowan
Comment
Below
are
some
comments
on
why
hospitals
should
be
considered
as
industrial
systems
needing
pretreatment
of
wastewater.
Hospitals
are
one
of
the
epicenters
for
multi­
drug
resistance.

What
follows
discusses
hospitals,
pathogens
in
wastewater,
their
ability
to
survive
the
rigors
of
a
treatment
works
and
then
their
potential
to
remain
in
the
environment.

Since
bacteriophages
are
able
to
carry
mobile
genetic
elements,
and
viruses
can
recombine,
these
constitute
a
worrisome
situation.
There
are
some
recent
reports
on
polio
virus
mutating
and
also
picking
up
genetic
elements
from
wild
polio
viruses,
thus
rendering
them
again
neurovirulent.
Some
papers
also
suggest
that
the
polio
virus
can
pick
up
mobile
genetic
elements
from
other
viruses.
If
it
goes
one
way,
one
might
also
assume
the
reverse.
Thus
in
addition
to
the
SARS
issue,
there
are
other
reasons
to
pressure
for
better
sludge
control.

The
Hospital
and
Multi
Drug
Resistant
Bacteria.
In
the
revamping
of
hospitals
to
meet
new
seismic
requirements,
serious
thought
should
be
applied
to
the
make­
up
of
sewer
effluents.
In
many
industrial
settings,
there
is
a
requirement
for
pre­
treatment.
This
requirement
accrues
to
the
need
for
protecting
receiving
waters,
hence
the
health
of
humans
and
the
environment.
Many
hospitals
should
consider
whether
or
not
they
fall
within
the
category
of
an
industrial
wastewater
generator.

Amongst
the
community
at
large,
including
sewer
treatment
plant
staff
there
is
a
distinct
lack
of
recognition
for
issues
relating
to
MDRB.
These
organisms
pass
from
sink
or
toilet
through
sewer
treatment
into
the
environment
at
large.
Although
current
water
quality
standards
are
silent
on
such
issues,
there
is
a
pressing
need
for
recognition.
Many
hospitals,
as
members
of
their
communities,
need
to
go
beyond
current
standards.
Contrary
to
popular
myth,
many
pathogens
do
survive
their
passage
through
a
sewer
treatment
plant
and
thus
remain
to
constitute
an
increased
public
health
risk.
That
this
situation
has
continued
for
some
time
may
be
attributed,
in
part,
to
economics
and
the
antiquated
water
quality
standards.
Nonetheless,
readily
available
scientific
and
medical
literature
are,
and
have
been
for
some
time,
replete
with
data
demonstrating
and
confirming
this
fact.
Studies
reported
in
the
scientific
and
medical
literature
dating
back
to
at
least
to
the
1970s
show
failure
of
treatment.
Thus,
this
is
hardly
new
knowledge.
[
Fontaine,
et
al,
(
1976);
Grabow,
et
al.
,
(
1973);
Linton,
et
al.,
(
1974);
Walter
et
al,.
(
1985)].

Prior
to
the
current
situation
of
wide
spread
antibiotic
resistance,
the
water
quality
standards
using
coliform
may
have
been
adequate.
The
situation
is
changed.
The
standards
have
not.
USEPA,
2003d
62
Previous
studies
have
shown
that
waste
effluents
from
hospitals
contain
higher
levels
of
antibiotic­
resistant
enteric
bacteria
than
waste
effluents
derived
from
other
sources
[
1,2,3,4,5,6].
Hospitals
are
epicenters
of
MDRB.

In
a
recent
meeting
of
our
task­
group,
one
of
the
members
raised
the
question
relating
the
survival
of
pathogens
once
the
material
has
left
the
treatment
works.
The
essence
of
the
question
is
related
to
the
survival
of
genetic
material.
Hence,
analyses
on
the
underlying
issue
of
surviving
MDRB.
The
question
went
something
like
this­­­"
If
Staphyloccus
aureus
were
found
dead,
did
that
mean
that
the
problem
was
solved?"
The
corollary
 
was
it
dead
or
merely
in
the
viable
but
non­
culturable
(
VNC)
state,
a
starvation
arrested
state,
or
killed
from
a
starvation
but
otherwise
recoverable
state
by
sudden
nutrient
excess
in
the
culture?
Additionally,
there
are
issues
of
the
re­
uptake
of
naked
DNA.

Recently,
in
discussing
mobile
genetic
elements
(
MGE),
Nielsen,
et.
al.
[
7,8],
demonstrated
that
DNA
was
well
protected
in
dead
cells
and
that
transforming
activity
remained.
The
survival
of
such
material
was
found
to
be
up
to
two
years
[
9].
Additionally,
these
papers
demonstrate
that
plant
rootss
could
transfer
MGEs
to
bacteria
and
visa
versa.
Thus
non­
pathogens
and
non­
bacteria
can
serve
as
reservoirs
for
maintaining
resistance
genes.
Pneumococci,
for
example,
can
take
up
naked
DNA
from
the
environment
(
natural
transformation
from
lysed
bacteria).
Thus
merely
finding
"
dead"
bacteria
may
be
no
assurance
that
risk
has
reached
acceptable
levels.
Further,
from
the
classical
work
of
Griffith,
we
know
that
pathogens
can
regain
virulence
from
dead
bacteria.

Additionally,
during
the
above
noted
meeting,
I
had
mentioned
some
notes
taken
at
a
recent
medical
grand
rounds.
The
speaker,
an
expert
on
infectious
disease,
indicated
that
there
is
strong
medical
evidence
that
about
one­
half
of
the
general,
non­
hospital
community
acquired
skin
infections
in
the
Greater
Los
Angeles
area
are
now
MRSA.
The
latest
issue
of
Skin
&
Allergy
News
also
had
a
front­
page
article
on
this.
Los
Angeles
is
about
2
years
from
Santa
Barbara
in
the
transfer
of
such
events.
Prior
to
1985,
vancomycin
resistance
in
human
pathogens
had
not
been
described
in
the
literature.
A
decade
later,
more
than
one­
half
of
the
hospitals
in
New
Jersey
contained
strains
of
vancomycin
insensitive
bacteria.
By
the
end
of
1998,
one
quarter
of
enterococci
isolated
from
intensive
care
units
across
the
U.
S.
expressed
resistance
to
vancomycin.

Recent
publications
in
the
medical
literature
discuss
the
cost
of
drug
resistant
bacteria.
The
annual
cost
in
the
U.
S.
was
estimated
to
be
upwards
of
$
30
billion
annually
(
Dominguez
EA,
et
al.
Infection
Control
&
Hospital
Epidemiology,
vol
21,#
1,
supp,
Jan
2000,
p
S4).

It
was
assumed
for
a
long
time
that
gene
transfer
between
different
species
of
microorganisms
is
a
very
rare
event
at
best;
that
view
has
changed.
The
available
evidence
suggests
that
interspecific
transfer
of
genes
has
occurred
between
the
three
major
groups
of
organisms:
archaebacteria,
eubacteria
and
eucaryotes.
There
is
very
strong
evidence
that
gene
transfer
easily
occurs
between
distantly
related
bacteria.
Marcinek,
et
al
[
10]
estimated
that
under
the
natural
conditions
of
a
sewer
treatment
works,
between
106
to
109
gene
transfer
events
between
different
E.
faecalis
strains
should
take
place
per
day.
The
maximum
number
of
transfer
events
for
the
sex
pheromone
USEPA,
2003d
63
plasmids
between
different
strains
of
E.
faecalis
in
the
municipal
sewage
water
treatment
plant
was
found
to
range
from
10(
5)
to
10(
8)
events
per
4
hour
period.
This
work
also
indicated
that
gene
transfer
should
take
place
under
nat
Iversen,
et
al,
[
11]
isolated
VRE
in
21
of
35
untreated
sewage
samples
(
60%),
from
5
of
14
hospital
sewage
samples
(
36%),
from
6
of
32
treated
sewage
samples
(
19%),
and
from
1
of
37
surface
water
samples.
It
was
speculated
that
antimicrobial
drugs
or
chemicals
released
into
the
sewage
system
sustained
VRE
in
the
system.
Others
[
5]
have
demonstrated
direct
evidence
that
related
tetracycline
resistance­
encoding
plasmids
have
disseminated
between
different
Aeromonas
spp.
and
E.
coli
and
between
the
human
and
aquaculture
environments
in
distinct
geographical
locations.
Collectively,
these
findings
provide
evidence
to
support
the
hypothesis
that
the
aquaculture
and
human
compartments
of
the
environment
behave
as
a
single
interactive
niche.

Ribeiro
[
12]
and
others
[
13]
have
found
that
as
these
organisms
progress
further
through
sewer
treatment,
the
level
of
resistance
and
number
transferred
plasmids
increases.
Reinthaler
et
al
[
14]
found
that
the
highest
resistance
rates
were
found
in
E.
coli
strains
of
a
sewage
treatment
plant
which
treats
not
only
municipal
sewage
but
also
sewage
from
a
hospital.
Thus,
these
authors
concluded
that
sewage
treatment
processes
contribute
to
the
dissemination
of
resistant
bacteria
in
the
environment.

One
of
the
issues
being
studied
locally
is
the
leaking
sewer
system
that
underlies
most
cities.
There
has
been
a
sufficiency
of
studies
to
raise
questions
about
exfiltrationøthe
loss
of
sewer
effluent
from
these
sewer
mains.
That
rising
ground
water
actually
enters
into
many
of
these
older
systems
is
now
well
beyond
question.
The
issue
is
one
of
logic.
If
rising
ground
water
gets
in
through
failing
joints
and
cracks,
what
keeps
sewer
water
from
utilizing
these
same
portals
when
the
surrounding
ground
water
falls
below
them?

Cenci,
et
al
[
15]
reviewed
the
incidence
and
the
patterns
of
the
antibiotic
and
metal
resistance
in
106
strains
of
Escherichia
coli
isolated
from
ground
waters,
used
also
as
drinking
water
supply.
These
organisms
were
studied
in
comparison
with
the
resistance
behavior
in
the
104
strains
of
the
same
microorganism
isolated
from
non
hospitalized
patients.
When,
however,
these
were
compared
to
hospitalized
patients,
the
patterns
of
the
antibiotic
multiresistances
and
the
strains
isolated
from
patients
and
from
ground
waters
did
not
differ
greatly.
The
authors
concluded
that
their
findings
strengthened
the
hypothesis
that
resistance
to
antibiotics
had
been
acquired
by
Escherichia
coli
strains
before
reaching
the
ground
waters.

If
the
above
has
any
validity,
then
what
of
the
possible
effects
of
different
pharmaceutical
groups
such
as
anti­
tumour
drugs,
antibiotics
and
contrast
media
as
well
as
absorbable
organically
bound
halogens
AOX
resulting
from
hospitals
effluent
input
into
sewage?
Recently,
the
occurrence
and
fate
of
pharmaceutically
active
compounds
(
PhACs)
in
the
aquatic
environment
was
recognized
as
one
of
the
emerging
issues
in
environmental
chemistry
and
as
a
matter
of
public
concern
[
16].
Residues
of
PhACs
have
been
found
as
contaminants
in
sewage,
surface,
and
ground­
and
drinking
water
samples.
Again
this
begs
the
issue
of
leaking
sewer
mains
and
a
need
for
pretreatment.
USEPA,
2003d
64
Most
antibiotics
and
their
metabolites
are
excreted
by
humans
after
administration
and
therefore
reach
the
municipal
sewage
with
the
excretions.
Kummerer,
et
al
[
17]
looked
at
a
worst
case
scenario
on
found
concentrations
of
the
antibiotics
in
hospital
effluents.
These
concentrations
were
estimated
and
compared
with
minimum
inhibitory
concentrations
for
susceptible
pathogenic
bacteria
and
with
the
genotoxic
potency.
Both
the
concentrations
calculated
for
hospital
effluents
and
the
adverse
effects
in
bacteria
were
in
the
same
order
of
magnitude.

AOX
are
mostly
persistent
in
the
environment,
and
accumulate
in
the
food
web.
One
important
source
of
AOX
in
hospital
effluents
may
be
x­
ray
contrast
media
containing
an
iodine
carbon
bond.
These
materials
may
also
add
to
selection
pressures
and
development
of
resistant
strains.

Others
[
18]
have
noted
that
the
mere
process
of
chlorinating
effluent
tends
not
only
to
increase
resistance,
but
also
increase
the
competitive
edge
of
these
survivors.
Thus,
we
are
now
seeing
developing
resistance
to
chlorine,
other
antiseptics,
and
disinfectants.
This
raises
some
interesting
academic
as
well
as
practical
questions
at
the
cellular
and
molecular
level.
For
example
would
developing
resistance
to
chlorine
also
affect
the
efficacy
of
hypochlorite
released
within
lysosomes,
there
by
reducing
effectiveness
of
leukocytes?

The
workers
at
sewer
plants
are
also
at
risk.
Several
papers
[
19,20,21]
have
reported
on
transfer
of
viral
particles
and
bacteria
in
aerosols
that
are
generated
by
and
surround
many
of
these
plants.
In
addition,
there
are
studies
on
wind
drift
of
these
plumes
into
the
surrounding
neighborhoods.

Response
These
comments
,
for
the
most
part,
do
not
address
that
portion
of
the
April
9,
2003
Federal
Register
notice
that
requested
comments
on
the
pathogen
portion
of
EPA's
Draft
Action
Plan.
One
comment,
the
issue
of
resistant
pathogens
originating
from
hospital
patients
with
a
potential
to
be
found
in
sewage
sludge,
are
responded
to
by
referring
to
Project
11
in
Section
VII
B
of
today's
notice
on
publishing
the
proceedings
of
the
USEPA­
USDA
Workshop
on
Emerging
Infectious
Disease
Agents
and
Issues
Associated
with
Animal
Manures,
Biosolids,
and
Other
Similar
By­
Products.
Among
the
information
from
the
Workshop
that
will
be
published
will
be
information
on
the
potential
for
the
occurrence
of
antibiotic
resistant
pathogens
in
sewage
sludge
and
animal
manures.

EPA
Log
#
8:
David
A.
Burrows
Comment
The
Pennsylvania
studies
(
Federal
Register
p.
17386)
should
be
peer
reviewed
studies
of
at
least
one
year
duration
and
with
as
broad
a
scope
as
possible.
A
thirty
day
sampling
period
is
insufficient
to
study
the
possible
regeneration
of
pathogens
that
could
occur
during
a
normal
year
of
agricultural
use
of
biosolids.
There
is
also
a
need
for
sampling
during
all
weather
conditions
normal
for
the
test
area.

A
molecular
pathogen
tracking
exposure
study
as
a
follow
up
to
the
PA/
USDA/
EPA
study
would
be
beneficial.
(
Federal
Register
p.
17386)
USEPA,
2003d
65
Response
First
paragraph
of
these
comments:
See
the
EPA
response
to
EPA
Log
#
40
regarding
the
Pennsylvania
field
studies
in
the
Exposure
Section
of
this
document.
The
study
design
will
be
peer
reviewed
to
consider
these
comments.

Second
paragraph:
EPA
now
views
the
molecular
pathogen
tracking
exposure
study
as
lower
priority
and
will
not
be
in
the
research
plan
for
projects
to
be
initiated
or
completed
within
2­
3
years.
The
execution
of
well­
designed
field
exposure
studies
as
described
in
the
Exposure
Section
of
this
document
should
provide
the
necessary
information
that
the
molecular
pathogen
tracking
study
would
have
provided.

EPA
Log
#
21:
Lynton
S.
Land
Comment
In
several
previous
letters
(
12
/
01
/
01,02
/
28
/
02,061
/
06
/
02)
I
have
asked
that
EPA
seriously
consider
the
role
of
gulls
in
transporting
human
pathogens
to
waterways
impaired
because
of
fecal
coliform
bacteria.
There
can
be
no
doubt
that
gulls
foraging
in
fields
to
which
Class­
B
sewage
sludge
has
been
land­
applied
will
be
contaminated
with
human
pathogens,
considering
that
the
average
sludge
truck
contains
trillions
of
CFU
(
Colony
Forming
Units).
The
Virginia
Department
of
Environmental
Quality
has
recently
concluded
that
Virginia
waterways
that
are
impaired
(
and
restricted
for
the
harvesting
of
oysters)
because
of
high
human
fecal
coliform
bacteria,
not
bacteria
from
wildlife,
based
on
BST
(
Bacterial
Source
Tracking)
studies.
There
is
no
excuse
whatsoever
to
permit
the
land
application
of
Class­
B
sewage
on
fields
within
the
foraging
range
of
gulls
near
waterways
impaired
because
of
high
human
fecal
coliform
levels.
Attached
is
some
previous
correspondence
with
the
Virginia
Department
of
Health,
previously
sent
to
EPA,
which
outlines
my
concern.
I
request
that
this
issue
be
formally
addressed
by
EPA
in
your
response
to
NRC's
criticism
of
existing
sewage
sludge
regulations.

Response
Project
4
"
Field
Studies
of
Application
of
Treated
Sewage
Sludge"
of
today's
FR
notice
could
develop
information
of
this
type.

EPA
Log
#
8:
David
A.
Burrows
Comment
There
is
a
need
for
the
use
of
indicator
organisms
such
as
Clostidium
perfringens
as
recommended
by
the
NRC.
(
Federal
Register
p.
17388)

Response
EPA
thanks
the
commenter
for
his
suggestion
which
will
be
brought
to
the
attention
of
EPA's
Pathogen
Equivalency
Committee
(
Please
see
also
Project
9
in
Section
VII
B
of
today's
Federal
Register
Notice
"
Support
Pathogen
Equivalency
Committee").
The
PEC
can
evaluate
and
recommend
the
use
of
indicator
organisms
other
than
the
current
indicator
organism,
fecal
coliforms,
specified
in
the
current
Part
503
Standards.

EPA
Log
#
12:
Edward
H.
Bryan
Comment
This
is
in
response
to
your
request
for
comments
on
sewage
sludge
disposal
regulations
relating
to
sludge
applied
to
land
and
is
with
reference
to
the
report
"
Biosolids
USEPA,
2003d
66
Applied
to
Land
"
by
the
NRC
Committee
EPA
commissioned
to
assist
in
reviewing
these
regulations.
On
Page
44
of
this
report,
Alternative
5e
is
titled
"
Beta
Ray
Irradiation
Process,"
and
described
as
irradiation
of
sludge
with
"
beta
rays
from
an
accelerator."
Beta
rays
are
not
emitted
from
an
accelerator
nor
is
it
technically
correct
to
call
the
process
of
irradiating
materials
by
use
of
a
beam
of
energized
electrons
from
an
accelerator
a
"
Beta
Ray
Irradiation
Process."
The
NRC
Committee
may
not
have
noted
these
technical
errors
in
the
regulations
or,
if
noted,
did
not
consider
them
to
be
within
the
scope
of
its
advisory
function
in
the
process
that
led
to
its
report.
However,
it
seems
appropriate
that
EPA
would
consider
correcting
these
errors
and
others
like
them
if
there
are
more
when
its
sludge
regulations
are
revised.
Alternative
5e
should
be
labeled
Electron
Beam
Irradiation
Process
and
the
phrase
"
beta
rays
from
an
accelerator
"
should
be
replaced
by
"
electrons
from
an
electron
accelerator."

Response
EPA
thank
you
for
your
comment
which
will
be
evaluated
as
soon
as
possible.
A
correction
to
Part
503
Standards
will
be
issued
if
deemed
necessary.

EPA
Log
#
29:
Henry
J.
Staudinger
Comment
E.
EPA's
Pathogen
Strategy
is
Not
Adequate.
NRC
Recommends
that
EPA
review
approaches
for
developing
microbial
analytical
methods
and
conduct
microbial
risk
assessments
to
analyze
sensitivity
and
to
ascertain
critical
information
needed
to
reduce
uncertainty
of
those
exposed
to
biosolids.

EPA's
willingness
to
consider
studies
to
better
understand
the
potential
adverse
health
consequences
of
pathogens
is
a
start.
However,
even
if
EPA
decides
to
fund
independent
studies,
the
lack
of
input
data
discussed
earlier
severely
limits
the
viability
of
the
strategy.

The
EPA/
USDA/
DEP
project
referred
to
is
not
designed
to
address
the
issues
raised
by
NRC.
Moreover,
as
discussed
earlier,
that
project
addresses
only
selected
pathogens
and
has
not
been
designed
to
test
biosolids
most
likely
to
contain
pathogens
present
when
health
complaints
have
been
made.
Industry
generated
studies
provide
little
comfort
that
objective
pathogen
information
will
become
available.

Response
See
the
EPA
response
to
Comment
Log
No.
51
in
the
Methods
Development
section
.
Please
see
the
EPA
response
to
EPA
Log
No.
40
concerning
the
Pennsylvania
Study
in
the
Exposure
Section
of
this
document.
In
addition,
please
see
Project
11:
Publish
the
Proceedings
of
USEPA­
USDA
Workshop
on
Emerging
Infectious
Disease
Agents
and
Issues
Associated
with
Animal
Manures,
Biosolids,
and
Other
Similar
By­
Products
in
Section
VII
B
of
today's
Federal
Register
Notice.

EPA
will
make
available
recent
information
on
pathogens
in
sewage
sludge
and
animal
wastes
by
publishing
the
proceedings
of
the
June
2001
USEPA­
USDA
workshop.
The
July
2002
NRC
Report
called
for
more
information
on
the
risks
of
disease
associated
with
pathogens
and
how
to
analyze
for
them.
It
also
called
for
more
information
on
the
reliability
of
sewage
sludge
USEPA,
2003d
67
disinfection
processes.
The
workshop
proceedings
document
will
partially
answer
the
questions
the
NRC
raised.

In
June
2001,
EPA
and
USDA
sponsored
a
workshop
on"
Emerging
Pathogen
Issues
in
Biosolids,
Animal
Manures,
and
Other
Similar
By­
Products"
(
USEPA,
in
press).
The
workshop
brought
together
experts
in
sewage
sludge
management
and
animal
wastes
to
review
the
state
of
the
science,
exchange
ideas
on
how
to
deal
with
unresolved
issues
and
suggest
areas
where
the
scientific
community
should
focus
its
efforts.
Participants
discussed:
°
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
immuno­
suppressed
conditions
to
pathogens.
As
stated
in
Category
E
(
Pathogens)
of
the
preliminary
strategy
dated
April
9,
2003
(
68
FR
17389),
EPA
will
make
available
the
information
produced
at
this
workshop
on
pathogens
in
sewage
sludge
and
animal
wastes
by
publishing
the
proceedings
of
the
workshop.
The
proceedings
from
the
workshop
have
been
peer
reviewed
by
national
and
international
experts,
and
the
report
will
be
published
in
early
2004.

In
the
future,
EPA
intends
to
use
the
information
that
was
produced
by
this
Workshop
to
evaluate
the
pathogen
portion
of
the
Part
503
Standards
and,
if
warranted,
propose
amendments
to
these
standards
for
public
comment.

EPA
Log
#
37:
David
A.
Burrows
Comment
On
page
17384
of
the
Federal
Register,
in
goal
#
3
of
"
Major
Long
Term
Goals..."
the
word
possibly
should
be
deleted
so
that
the
statement
reads
"
To
strengthen
its
biosolids
program,
EPA
will
include
quantitative
microbial
assessment,
improved
understanding
of
exposure
pathways/
scenarios,
and
molecular
tracking."

EPA
has
apparently
not
developed
a
clear
plan
to
determine
the
effectiveness
of
site
restrictions
in
relation
to
Class
B
sewage
sludge.
The
NRC
recommended
(
page
305
NRC
report):
"
Studies
should
be
conducted
to
determine
whether
the
site
restrictions
specified
for
Class
B
biosolids
in
the
Part
503
rule
actually
achieve
their
intended
effect
with
regard
to
pathogen
levels."
The
NRC
also
recommended:
"
Site
restrictions,
bufferzones,
and
holding
periods
for
land
applied
Class
B
biosolids
should
consider
geographic
and
site­
specific
conditions
that
affect
pathogen
fate
and
transport"
(
page
304
NRC
report).

Response
See
the
response
to
Comment
log
No.
29
in
this
section.
As
stated
in
this
response,
amendments
to
the
pathogen
section
of
the
Part
503
standards
including
site
restrictions
for
Class
B
sewage
sludge
are
possible
after
EPA
evaluates
information
from
the
Workshop
described
in
Project
11
in
Section
VII
B
of
today's
Federal
Register
Notice.
USEPA,
2003d
68
EPA
Log
#
40:
Thomas
F.
Albert
Comment
Comment
#
1:
On
page
17384
in
item
3
of
"
Major
Longer­
Term
Goals
­­­­"
the
word
"
possibly"
should
be
deleted.
To
strengthen
its
biosolids
program
EPA
SHOULD
include
(
not
possibly
include);
quantitative
microbial
risk
assessment,
improved
understanding
of
exposure
pathways/
scenarios,
and
molecular
tracking.

Comment
#
23:
On
page
17388
in
the
section
"
How
EPA
Plans
to
Address
NRC
Pathogen
Recommendations"
is
noted
that
"
EPA
currently
uses
a
technology
and
management
practices
based
approach
to
minimize
pathogen
exposure."
This
is
MISLEADING.
The
current
EPA
approach
reduces
pathogen
exposure
but
there
is
no
evidence
that
it
minimizes
pathogen
exposure.
If
EPA
has
proof
that
these
practices
do
truly
minimize
(
rather
than
just
reduce)
pathogen
exposure,
then
EPA
should
present
proof.
In
the
interests
of
protecting
human
health,
why
doesn't
EPA
now
take
a
risk
based
approach
to
assessing
pathogens
in
sewage
sludge
(
as
noted
on
page
263
of
NRC
report)?
In
1993
when
standards
were
set
for
the
Part
503
rule,
it
may
not
have
been
e
practical
to
set
risk
based
pathogen
standards.
It
is
now
possible
to
set
risk
based
pathogen
standards,
why
doesn't
EPA
propose
this
in
its
response
to
the
NRC
report?

Comment
#
24:
On
page
17388
in
the
section
"
How
EPA
Plans
to
Address
NRC
Pathogen
Recommendations"
is
another
mention
of
EPA
"
Considering"
an
action?
EPA
"
is
considering
studies
to
better
understand
the
measurement,
control,
and
fate
of
pathogens
during
the
production
and
land
application
of
sewage
sludge."
Why
on
earth
hasn't
EPA
already
done
this?
In
the
interest
of
human
health
such
studies
should
have
already
been
done.
If
they
have
not
been
done
they
should
be
a
high
priority
for
doing.
"
Considering"
is
the
wrong
word,
EPA
should
DO
these
studies
NOW.

Comment
#
25:
On
page
17389
in
the
"
Research"
section
EPA
is
again
"
considering"
an
action.
EPA
"
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."
EPA
then
follows
with
a
masterpiece
of
understatement,
"
Results
of
such
research
will
assist
the
Agency
in
determining
where
improvements
may
be
needed"
(
Note
that
improvements
MAY
be
needed!)
Why
is
EPA
only
CONSIDERING
research
in
these
3
areas?
These
areas
are
all
included
in
NRC
recommendations.
EPA
should
be
DOING
these
studies
not
just
"
considering"
such
studies.
What
possible
excuse
can
EPA
offer
for
not
doing
such
studies?

Comment
#
26:
On
page
17389
(
research
section)
is
there
again
a
brief
mention
of
the
cooperative
EPA/
USDA/
PA
DEP
sludge
study
in
Pennsylvania?

Comment
#
27:
On
page
17389
(
research
section
)
mention
is
made
of
sludge
pathogen
studies
at
the
University
of
Arizona.
Have
these
studies
been
peer
reviewed
at
the
design
stage?
Will
they
be
peer
reviewed
at
the
draft
final
report
stage?
USEPA,
2003d
69
Comment
#
28:
On
page
17389
(
research
section)
it
is
good
to
see
mention
of
"
phosphorus
overload''
as
a
concern
in
relation
to
sewage
sludge
applied
to
land.
EPA
should
clearly
admit
that
current
use
of
sewage
sludge
on
farm
land
overloads
the
land
with
phosphorus
(
exceeds
need
by
the
plants)
and
thereby
contributes
to
phosphorus
runoff
and
subsequent
pollution
of
groundwater
and
streams.
If
on
the
other
hand,
EPA
has
proof
that
this
is
not
the
case,
it
should
be
mentioned.

Comment
#
29:
At
the
top
of
page
17390.
the
last
7
lines
of
the
"
research
section''
contain
one
of
the
rare
mentions
of
pathogen
risk
assessment,
but
again
it
is
"
weasel
worded"
when
we
see
that
EPA
considers
this
a
potential
future
activity
and
is
only
"
considering"
other
relevant
work.
The
EPA
statement
reads,
"
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,
 
"
Why
are
the
pathogens
studies
"
potential"
and
"
future"?
Why
aren't
they
being
done
NOW?
Why
is
EPA
"
considering"
continuing
site
specific
evaluations?
Why
isn't
EPA
certain
that
it
will
continue
site
specific
evaluations?

Response
Please
see
the
EPA
responses
to
comment
Log
No.
51
in
the
Methods
Development
section
and
comment
Log
No.
29
in
this
section
of
the
document.
Also
see
the
response
to
comments
Log
No.
40
on
the
Pennsylvania
study
in
the
Exposure
Section
of
this
document.
As
responded
to
this
commenter
in
the
Survey
section
of
this
document,
EPA
believes
that
it
has
removed
ambiguity
from
its
research
action
plan
as
described
in
Section
VII
B
of
today's
Federal
Register
notice.

EPA
Log
#
25:
Northumberland
Association
for
Progressive
Stewardship
(
NAPS)
Sewage
Sludge
Study
Group
Comment
E.
Pathogens
Lines
898­
939.
We
strongly
suggest
that
EPA
list
the
members
and
contributors
to
the
Water
Environment
Research
Foundation
(
WERF),
as
well
as
other
"
independent"
research
organizations
and
make
this
information
public,
as
you
have
with
other
organizations
in
your
paper.
Furthermore,
we
recommend
that
the
degree
to
which
such
organizations
rely
on
support
from
sludge
land
application
companies
be
taken
into
consideration
when
evaluating
their
data
and
recommendations.
This
also
applies
to
colleges
and
universities.

Response
Please
see
EPA's
responses
to
Log
No.
8
in
the
Risk
Assessment
section
and
to
your
previous
comment
in
the
Survey
section
of
this
document
that
raised
the
issue
of
data
integrity
from
sources
associated
with
the
wastewater
industry.
EPA
will
consider
for
use,
all
data
and
information
that
meets
the
standards
of
EPA's
Data
Quality
Guidelines.

Environmental
Groups
EPA
Log
#
43:
Natural
Resources
Defense
Council
(
NRDC)
USEPA,
2003d
70
Comment
PATHOGENS
NRC's
Report
makes
a
number
of
important
recommendations
for
improving
the
technology­
based
approach
used
by
EPA
to
address
risks
posed
by
pathogens
in
sewage.
Those
recommendations
include
conducting
an
updated
national
survey
of
pathogens
in
raw
and
treated
sludges,
analyzing
hazard
information
reflective
of
newly
available
information
using
geographical
and
site­
specific
factors
in
setting
use
restrictions;
considering
use
of
additional
indicator
organisms;
verifying
the
efficacy
of
current
site­
restrictions;
and
using
quantitative
microbial
risk
assessment
("
QMRA
")
to
improve
current
`
regulatory
criteria
("
PEC").

EPA's
Response
to
these
specific
recommendations
is
both
vague
and
incomplete.
Reference
is
made
to
"
an
ongoing
biosolids
research
program
focused
on
selected
pathogens,"
but
EPA
fails
to
elaborate
on
the
scope
of
this
research
program
or
what
particular
studies
fall
within
its
purview.
Three
possible
research
priorities
are
listed:
"(
1)
development
of
improved
pathogen
analytic
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."
NRDC
agrees
that
these
general
areas
of
research
are
important
and
could
potentially
lead
to
the
implementation
of
some
of
the
structural
changes
to
pathogen
regulations
recommended
by
NRC.
However,
the
lack
of
detail,
specificity,
and
commitment
in
EPA's
Response
is
extremely
concerning.
Pursuant
to
NRC
'
s
recommendations,
EPA
needs
to
design
a
systematic
approach
to
incorporating
these
potential
research
priorities
into
a
long­
term
plan
for
modernizing
the
pathogen
regulations.
In
addition,
while
additional
research
on
pathogens
in
sludge
could
be
helpful,
it
needs
to
be
done
by
independent
scientific
bodies
that
are
not
funded
by
the
sludge
industry
through
membership
dues,
grants,
or
other
sources
of
funding.

EPA's
discussion
of
the
University
of
Arizona
study
exemplifies
the
general
deficiencies
in
EPA's
limited
approach.
The
research
parameters
and
goals
of
this
single
study
appear
promising.
Nonetheless,
this
study,
albeit
at
several
sites
around
the
country,
is
incapable
of
producing
the
type
of
data
and
information
necessary
for
a
comprehensive
evaluation
and
overhaul
of
existing
pathogen
regulatory
criteria.
Without
complementary
studies
across
the
country
that
are
planned
and
coordinated
with
broader
goals
if
mind,
such
data
and
information
will
remain
out
of
EPA's
reach.

Response
With
respect
to
developing
analytical
protocols
for
microbials,
see
Project
3
"
Methods
Development,
Optimization,
or
Validation
for
Microbial
Pollutants
in
Sewage
Sludge"
in
Section
VII
B
of
today's
Federal
Register
Notice.
With
respect
to
including
microbials
in
an
analytical
survey,
EPA
has
committed
to
do
that
if
adequate
microbial
analytical
protocols
are
available
(
see
Project
No.
5
"
Targeted
National
Survey
of
Pollutants
in
Sewage
Sludge"
in
Section
VII
B
of
today's
Federal
Register
Notice
as
described
in
the
Survey
Section
of
this
document.
With
respect
to
QMRA
development,
in
Section
VII
B
in
today's
Federal
Register
Notice,
see
Project
8:
"
Assess
the
Quality
and
Utility
of
Data,
Tools
and
Methodologies
to
Conduct
Microbial
Risk
Assessments
on
Pathogens."

To
better
inform
research
activities
in
sewage
sludge
and
microbial
risk
assessment,
EPA
will
inventory
and
assess
data,
methods,
and
tools
for
risk
assessment
on
pathogens
in
sewage
USEPA,
2003d
71
sludge.
The
NRC
report
indicated
that
additional
scientific
work
is
needed
to
reduce
persistent
uncertainty
about
the
potential
for
adverse
human
health
effects
from
exposure
to
biosolids.
The
document
goes
on
to
recommend
that
EPA
use
improved
risk
assessment
methods.
EPA
currently
regulates
the
processing,
use,
and
disposal
of
sewage
sludge
through
CWA
regulations
in
Part
503,
that
impose
numeric
standards
and
management
practices
for
sewage
sludge
applied
to
land.
For
the
most
part,
the
numeric
standard
for
chemical
pollutants
in
existing
regulations
are
risk­
based,
while
the
microbial
management
practice
standards
are
technology­
based.
In
issuing
Part
503
in
1993,
the
Agency
acknowledged
that
it
lacked
essential
tools
and
data
to
conduct
microbial
risk
assessments
on
sewage
sludge.
This
project
will
address
those
microbial
risks
posed
by
exposure
to
sewage
sludge,
it
will
serve
as
a
vehicle
to
better
define
the
deficiencies
in
microbial
risk
assessment,
and
better
identify
research
needs
for
sewage
sludge
risk
assessment.

This
project
will
start
with
a
problem
formulation
step
to
identify
the
key
elements
in
assessing
pathogen
risks
in
land­
applied
sewage
sludge.
During
the
second
phase,
EPA
will
develop
a
plan
to
identify
the
available
and
appropriate
methods
and
data
to
perform
the
risk
assessment
defined
in
problem
formulation.
An
expert
panel
will
review
the
material
and
EPA
will
address
panel
comments
in
the
final
document.

EPA
will
develop
a
scenario
that
includes
issues
involved
in
the
risk
assessment:
sources
of
organisms,
potential
receptors,
routes
of
exposure,
and
environmental
and
management
conditions
affecting
exposure.
The
scenario
will
also
identify
pathogens
based
on
studies
of
the
composition
of
sewage
sludge,
incidence
of
contamination
reported
in
the
literature,
and
numbers
of
organisms
recovered
from
sewage
sludge.
The
Agency
will
develop
rates
and
methods
of
application
protective
of
at­
risk
populations
(
such
as
those
with
occupational
exposures
or
those
living
near
application
sites).
The
study
will
also
consider
sensitive
populations
such
as
children,
the
elderly,
or
those
persons
with
immune
system
problems.
We
will
develop
a
conceptual
model
to
characterize
different
routes
of
exposure
to
microbes
under
realistic
scenarios.
The
workgroup
will
lay
the
foundation
for
defining
the
conditions
and
criteria
for
microbial
risk
assessments
of
sewage
sludge.

The
workgroup
will
also
review
the
scientific
literature
to
identify
available
tools,
methods
and
data,
as
well
as
gaps,
for
conducting
an
assessment
under
the
defined
conditions.
An
expert
panel
will
critique
the
findings
and
recommend
future
research
for
microbial
risk
assessment
of
sewage
sludge.
The
final
product
in
FY
2005
will
be
a
peer­
reviewed
plan
for
future
analysis.

With
respect
to
an
ongoing
EPA
pathogen
research
program,
EPA
is
committed
to
reviewing
the
published
results
of
the
USEPA­
USDA
Workshop
referenced
in
response
to
Comment
Log
No.
29
in
this
section
of
this
document.
Finally
with
response
to
the
criticism
of
the
University
of
Arizona
study,
the
project
leader
has
performed
these
type
of
studies
in
several
locations
in
the
United
States
under
various
meteorological
conditions.
The
results
of
these
studies
have
just
been
published
and
EPA
will
be
reviewing
these
(
Rusin
et
al,
2003).

Municipal
Wastewater
Treatment
Plants
USEPA,
2003d
72
EPA
Log
#
14:
Metro
Wastewater
Reclamation
District
Comment
The
Metro
District
endorses
the
NRC
report's
recommendation
to
study
the
correlation
between
pathogen
destruction
and
indicator
organism
levels
in
biosolids
from
various
treatment
processes,
such
as
anaerobic
digestion,
aerobic
digestion,
and
lime
stabilization.
Studies
of
this
type
will
provide
data
that
either
provide
substantiation
for
the
protective
nature
of
the
Class
A
and
Class
B
pathogen
destruction
requirements,
or
show
there
is
a
need
to
revise
the
Class
A
or
Class
B
pathogen
destruction
criteria.

Response
Project
No.
4
"
Field
Studies
of
Application
of
Treated
Sewage
Sludge"
in
Section
VII
B
can
be
expanded
in
the
future
to
study
the
correlation
between
pathogen
destruction/
reduction
processes
and
the
presence/
quantification
of
indicator
organisms
in
the
treated
sewage
sludge.

Unknown
EPA
Log
#
34:
Anonymous
Comment
A
second
issue
is
the
lack
of
critical
specific
detail
on
many
of
the
EPA
responses.
Many
of
the
responses
fail
to
define
clear
timelines
on
achieving
any
type
of
results.
The
NRC
recommended
"
the
Agency
review
approaches
for
developing
microbial
analytical
methods
and
conducting
risk
assessments
(
Quantitative
Microbial
Risk
Assessments)".
The
EPA's
response
was
"
is
considering
studies".
The
open
ended
nature
of
this
type
of
response
is
not
acceptable.
The
response
should
be
direct
and
clear.

The
third
major
issue
with
the
draft
response
is
the
significant
failure
to
address
many
of
the
recommendations.
The
number
of
specific
cases
are
too
numerous
to
include
in
this
summary
however
some
specific
examples
include
:
(
1)
"
The
PEC
should
be
funded
,
supported,
and
officially
sanctioned
as
an
integral
part
of
the
federal
biosolids
program"
(
NRC
report
p.
96)
and
(
2)
"
Provisions
for
allowing
distribution
of
Class
A
biosolids
in
bags
or
other
containers
should
not
be
allowed
when
they
do
not
meet
the
pollutant
concentration
limits"
(
NRC
report
p.
97).

Response
In
response
to
public
comments
on
the
draft
April
2003
FR
Notice,
EPA
attempted
in
this
final
response
to
provide
clear
timelines
and
more
details
on
specific
activities
or
research,
and
to
better
describe
how
those
activities
address
NRC
recommendations,
areas
of
uncertainty
identified
in
the
NRC
report,
and
areas
the
Agency
believes
will
improve
the
sewage
sludge
program.
For
support
to
the
PEC,
please
see
Project
9
"
Support
Pathogen
Equivalency
Committee."

Association
EPA
Log
#
30:
Tri­
TAC
Comment
Pathogens
USEPA,
2003d
73
Tri­
TAC
generally
supports
EPA's
planned
pathogen
research
areas,
development
of
improved
pathogen
analytical
techniques,
assessment
of
exposure
and
risk
for
critical
pathways,
and
evaluation
of
biosolids
processing
and
land
application
methods
and
site
restrictions.

The
NRC
Report
recommended
that
the
EPA
consider
funding,
supporting,
and
officially
sanctioning
the
Pathogen
Equivalency
Committee
(
PEC)
as
part
of
the
federal
biosolids
program.
While
Tri­
TAC
does
not
object
to
this
recommendation,
we
do
suggest
that
if
EPA
decides
to
officially
recognize
the
committee,
that
it
open
membership
on
the
PEC
to
include
qualified
scientists
employed
by
wastewater
treatment
plants
and
private
biosolids
contractors.
As
currently
structured,
the
PEC
includes
only
employees
from
EPA
and
the
CDC.
Because
of
this
limitation,
the
PEC
has
not
benefited
from
the
expertise
that
scientists
from
the
regulated
community
could
contribute,
especially
related
to
current
application
methods,
site
restrictions,
and
other
local
variables.

Tri­
TAC
supports
EPA's
plans
to
continue
funding
relevant
scientific
research
concerning
the
impact
of
biosolids
on
human
health
and
the
environment.
As
part
of
this
effort,
Tri­
TAC
recommends
that
EPA
consider
funding
studies
conducted
by
wastewater
treatment
agencies
or
private
biosolids
applicators.
These
entities
may
be
able
to
develop
data
useful
to
EPA's
long­
term
goals
of
understanding
the
benefits
and
potential
consequences
of
biosolids
land
application
and
determining
whether
existing
Part
503
site
management
restrictions
are
effective.
In
addition,
both
wastewater
treatment
agencies
and
private
biosolids
management
companies
may
already
have
data
from
in­
house
studies
that
could
be
useful
for
EPA's
activities.
Tri­
TAC
encourages
EPA
to
tap
into
this
resource.

Response
EPA
appreciates
these
comments.
As
described
in
Project
No.
9
in
Section
VII
B
of
today's
Federal
Register
Notice,
EPA
will
devote
sufficient
resources
to
the
Pathogen
Equivalency
Committee.
Finally,
EPA
intends
to
reach
out
to
stakeholders
including
wastewater
treatment
agencies
to
obtain
needed
data
external
to
the
Agency.

EPA
Log
#
50:
Water
Environment
Federation
(
WEF)

Comment
Focus
on
Priorities
 
The
document
reflects
a
strong
emphasis
on
pathogens
and
odors,
which
are
areas
of
primary
concern
to
the
public.
WEF
agrees
that
EPA
should
support
further
study
on
pathogen
issues
in
biosolids,
animal
manures
and
other
similar
by­
products.
EPA
should
also
support
additional
research
on
odor
associated
with
biosolids
processing,
utilization,
and
management
of
biosolids
at
the
treatment
plant
to
minimize
odors
during
subsequent
processing
or
land
application.
Some
promising
early
research
has
been
accomplished
in
these
areas
and
needs
to
be
continued
so
as
not
to
lose
momentum
and
progress
made
to
date.

E.
Pathogens
In
the
strategy,
EPA
indicated
that
the
Agency
is
considering
studies
to
better
understand
measurement,
control,
and
fate
of
pathogens
during
the
production
and
land
application
of
biosolids.
The
strategy
also
describes
several
programs
focused
on
developing
a
better
understanding
of
pathogens.
WEF
supports
ongoing
research
programs
focused
on
pathogen
USEPA,
2003d
74
issues
and
EPA's
continued
use
of
the
Pathogen
Equivalency
Committee.
WEF
also
encourages
EPA
to
continue
collaborating
with
USDA,
which
is
grappling
with
similar
pathogen
concerns
in
land
applied
manures,
and
to
review
and
evaluate
relative
WERF
programs.

Response
EPA
agrees
with
these
comments.

EPA
Log
#
46:
Association
of
Metropolitan
Sewerage
Agencies
(
AMSA)

Comment
Pathogens
AMSA
generally
supports
EPA's
planned
pathogen
research
areas:
development
of
improved
pathogen
analytical
techniques,
assessment
of
exposure
and
risk
for
critical
pathways,
and
evaluation
of
biosolids
processing
and
land
application
methods
and
site
restrictions.

The
NRC
Report
recommended
that
the
EPA
consider
funding,
supporting,
and
officially
sanctioning
the
Pathogen
Equivalency
Committee
(
PEC)
as
part
of
the
federal
biosolids
program.
While
AMSA
does
not
object
to
this
recommendation,
we
do
suggest
that
if
EPA
decides
to
officially
recognize
the
committee,
that
it
open
membership
on
the
PEC
to
include
qualified
scientists
employed
by
wastewater
treatment
plants
and
private
biosolids
contractors.
As
currently
structured,
the
PEC
includes
only
employees
from
EPA
and
the
CDC.
Because
of
this
limitation,
the
PEC
has
not
benefited
from
the
expertise
that
scientists
from
the
regulated
community
could
contribute,
especially
related
to
current
application
methods,
site
restrictions,
and
other
local
variables.

AMSA
supports
EPA's
plans
to
continue
funding
relevant
scientific
research
concerning
the
impact
of
biosolids
on
human
health
and
the
environment.
As
part
of
this
effort,
the
Association
recommends
that
EPA
consider
funding
studies
conducted
by
wastewater
treatment
agencies
or
private
biosolids
applicators.
These
entities
may
be
able
to
develop
data
useful
to
EPA's
long­
term
goals
of
understanding
the
benefits
and
potential
consequences
of
biosolids
land
application
and
determining
whether
existing
Part
503
site
management
restrictions
are
effective.
In
addition,
both
wastewater
treatment
agencies
and
private
biosolids
management
companies
may
already
have
data
from
in­
house
studies
that
could
be
useful
for
EPA's
activities.
AMSA
encourages
the
Agency
to
tap
into
this
resource.

Response
EPA
agrees
with
these
comments.
Please
see
the
response
to
Comment
Log
Nos.
30
and
50
in
this
section
of
this
document.

Counties
EPA
Log
#
28:
Solano
County
Department
of
Environmental
Management
Comment
3.
Pathogens:
their
existence
and
management
Solano
County
DEM
is
not
only
interested
in
the
range
of
pathogens
found
in
biosolids,
but
the
mortality
of
the
pathogens
as
a
result
of
different
treatment
and
land
application
processes.
The
USEPA
response
appears
to
address
this
issue
as
part
of
its
three
item
approach.
Of
interest
to
USEPA,
2003d
75
Solano
County
DEM
in
regards
to
the
land
application
of
Class
B
biosolids
is
a
comparison
study
on
mortality
rates
of
pathogens
between
actual
sites
where
incorporation
of
biosolids
is
done
versus
those
sites
where
only
surface
application
of
biosolids
is
used.
Such
a
project
should
include
a
study
on
the
impacts,
if
any,
these
two
different
application
methods
have
on
long
term
potential
exposure
of
animals
and
people
to
pathogens
or
other
contaminants.

Response
Project
No
4
Field
Studies
of
Application
of
Treated
Sewage
Sludge
in
Section
VII
B
of
today's
Federal
Register
Notice
responds
to
these
comments.

States
EPA
Log
#
52:
Washington
State
Department
of
Ecology
CommentPathogen
Equivalency
Committee.
In
its
response
EPA
notes
that
it
has
an
ongoing
biosolids
research
program
focus
on
selected
pathogens,
and
is
expanding
the
program
during
this
fiscal
year.
EPA
says
in
regard
to
the
Pathogen
Equivalency
Committee,
"
The
Agency
formed
and
has
supported
the
PEC
since
1985."

I
am
glad
to
hear
that
EPA
is
able
to
expand
its
research
program
for
pathogens
in
biosolids.
With
regard
to
support
for
the
PEC,
however,
I
am
disappointed
to
see
EPA
make
the
above
statement
because
it
again
illustrates
a
significant
disconnect.
Allowing
the
PEC
to
exist
is
not
the
same
as
supporting
it.
My
concept
of
support
must
be
markedly
different,
but
I
don't
believe
I
know
a
single
person
(
and
after
15
years
in
this
area
of
work
I
know
a
few)
who
would
argue
that
the
PEC
has
been
adequately
supported
(
except
possibly
the
author
of
the
EPA
response
here).
A
report
contracted
by
EPA
and
prepared
by
Dr.
Charles
Haas
at
Drexel
University,
and
actually
cited
in
the
NRC
report
documents
shortcomings
and
needs.
The
very
first
short
term
recommendation
begins
by
saying,
"
At
present
the
bulk
of
the
clerical
and
secretarial
functions
of
the
PEC
(
e.
g.,
correspondence
with
petitioners,
arrangements
for
meetings,
maintenance
of
files)
is
personally
performed
by
the
chairman
of
the
committee."
This
is
an
appalling
use
of
a
valuable
resource.
I
believe
EPA
could
say
that
the
PEC
is
supported
if
it
would
implement
the
rather
modest
recommendations
in
Dr.
Haas'
report.

Response
Project
No.
9
Support
Pathogen
Equivalency
Committee
in
Section
VII
B
of
today's
notice
responds
to
these
comments.

EPA
Log
#
53:
Michigan
Department
of
Environmental
Quality
CommentSection
VIII.
E.
Pathogens
­
Pathogen
Activities
­
EPA's
Pathogen
Equivalency
Committee
(
PEC)
It
is
stated
that
the
Agency
"
formed
and
has
supported
the
PEC
since
1985".
This
statement
does
not
reflect
what
has
actually
been
happening.
It
is
my
impression
that
the
PEC
has
struggled
to
perform
its
job
as
long
as
it
has
existed
with
virtually
no
support
and
funding.
The
NAS
committee
found
that
the
PEC
was
inadequately
supported
and
recommended
on
pages
96­
97
that
they
be
funded,
supported,
and
officially
sanctioned
as
an
integral
part
of
the
federal
biosolids
USEPA,
2003d
76
program.
The
Agency
must
either
commit
to
all
of
the
recommendations
in
the
NAS
report
and
those
provided
by
an
independent
assessment
report
done
by
Chuck
Haas
(
2001)
and
cited
in
the
NAS
report,
or
make
a
policy
decision
not
to
allow
new
technology
for
biosolids
treatment.

Response
Please
see
the
response
to
EPA
Log
No.
52.

EPA
Log
#
48
and
39
(
duplicates):
Wisconsin
Department
of
Natural
Resources
Comment12.
Section
VIII.
E.
Pathogens
­
Research
­
It
is
stated
that
EPA
has
an
ongoing
and
expanded
biosolids
research
program
focused
on
specific
pathogens.
More
specific
detail
should
be
provided
on
this
program
and
its
specific
projects.
It
is
also
stated
that
EPA
is
"
considering"
research
in
at
least
three
general
areas.
Much
more
specific
detail
is
needed
for
what
is
under
consideration
and
what
will
actually
be
done.

13.
Section
VIII.
E.
Pathogens
­
Pathogen
Activities
­
It
is
stated
that
EPA
and
Duke
University
published
a
paper
examining
potential
health
effects
from
odor
emissions.
This
paper
has
been
largely
misunderstood
and
inappropriately
used
since
its
publication.
Is
EPA
purporting
that
this
paper
actually
published
results
demonstrating
health
effects
from
biosolids
odors
at
land
application
sites?
No
causal
relationship
conclusions
between
biosolids
odor
and
health
effects
were
drawn
from
that
paper
by
this
reader.
The
reason
for
citing
this
paper
in
this
response
should
be
clarified.
At
the
same
time
the
study
underway
by
the
University
of
Arizona
Water
Quality
Center
is
very
critical
and
will
provide
much
needed
data.
This
work
should
be
continued
to
be
supported.

14.
Section
VIII.
E.
Pathogens
­
Pathogen
Activities
­
EPA's
Pathogen
Equivalency
Committee
(
PEC)
­
It
is
stated
that
the
Agency
"
formed
and
has
supported
the
PEC
since
1985".
In
fact
the
NAS
committee
found
that
the
PEC
was
inadequately
supported
and
recommended
on
pages
96­
97
that
they
be
funded,
supported,
and
officially
sanctioned
as
an
integral
part
of
the
federal
biosolids
program.
This
included
the
need
to
have
a
formal
portion
of
their
time
dedicated
to
PEC
responsibilities
and
adequate
funding
provided.
The
Agency
must
either
commit
to
all
of
the
recommendations
in
the
NAS
report
and
those
provided
by
an
independent
assessment
report
done
by
Chuck
Haas
(
2001)
and
cited
in
the
NAS
report,
or
make
a
policy
decision
not
to
allow
new
technology
for
biosolids
treatment.
We
would
vehemently
object
to
the
latter
option,
but
the
PEC
will
soon
become
unworkable
unless
a
dedicated
commitment
is
made
to
support
it.

15.
Section
VIII.
E.
Pathogens
­
Pathogen
Activities
­
A
WERF
study
evaluating
phosphorus
availability
in
biosolids
is
an
important
study.
However,
it
is
hoped
that
site
conditions
and
management
practices
are
examined
as
well
as
phosphorus
availability
in
assessing
potential
impacts
to
surface
and
groundwater.
This
should
be
further
explained.
It
is
also
unclear
why
a
phosphorus
study
was
listed
under
"
Pathogen
Activities".

16.
Section
VIII.
E.
Pathogens
­
Planned
Pathogen
Activities
­
It
is
stated
that
EPA
is
"
considering"
studies
to
assess
treatment
efficacy
and
natural
attenuation
in
soil
after
application.
Both
of
these
may
be
part
of
the
Exposure
Study
referenced
above
in
comment
8
and
in
Part
B
of
USEPA,
2003d
77
the
response,
but
that
is
not
clear.
Both
studies
are
critical
and
should
be
conducted.
As
recommended
on
page
97
of
the
NAS
report,
standard
design
criteria
should
be
adopted
nationally
and
these
studies
are
mandatory
to
establish
that
criteria.

Response
Please
see
in
Section
VII
B
of
today's
FR
notice
Project
No.
3
(
Methods
Development,
Optimization,
and
Validation
for
Microbial
Pollutants
in
Sewage
Sludge)
and
Project
No.
8
(
Assess
the
Quality
and
Utility
of
Data,
Tools
and
Methodologies
to
Conduct
Microbial
Risk
Assessments
on
Pathogens)
for
a
description
of
specific
research
projects
focused
on
pathogens.

EPA
is
aware
of
the
Duke
University
publication
on
the
human
health
impacts
of
odors.
EPA
has
not
developed
a
position
as
of
yet
on
the
findings
of
this
report.
EPA
is
also
aware
of
the
research
being
conducted
at
the
University
of
Arizona
and
will
be
tracking
this
and
other
studies
of
this
type.

Project
No.
9
Support
Pathogen
Equivalency
Committee
in
Section
VII
B
is
responsive
to
the
comments
contained
in
the
third
paragraph.
Finally
in
response
to
the
last
paragraph
of
these
comments,
Project
4
in
Section
VII
B
(
Field
Studies
of
Application
of
Treated
Sewage
Sludge)
address
these
comments.

EPA
Log
#
??
59
(
EDKT
#
101):
New
Jersey
Department
of
Environmental
Protection
Comment
There
was
no
mention
of
the
work
being
performed
by
the
Interagency
Steering
Committee
on
Radiation
Standards
(
ISCORS).
Both
ISCORS
and
this
Department
have
gathered
extensive
information
with
regards
to
naturally
occurring
radionuclides
in
biosolids.
The
EPA
should
consider
this
information
in
fulfilling
its
obligation
in
responding
to
and
implementing
the
recommendations
in
the
NRC
report.

Response
As
stated
on
page
28
of
the
NRC
report
"...
radioactive
contaminants
were
not
included
in
the
committee's
assessment,
even
though
the
committee
is
aware
that
radioactive
compounds
may
be
present
in
biosolids."
That
issue
and
resulting
studies
is
under
the
aegis
of
ISCORS.
Results
on
this
activity
were
published
in
the
Federal
Register
as
an
interagency
Federal
Government
product
on
November
26,
2003
at
68
Federal
Register
66503­
66504.

TOPIC
F.
HUMAN
HEALTH
STUDIES
Summary
Response
EPA
received
a
large
volume
of
comments
on
this
topic.
EPA
takes
seriously
the
allegations
of
human
health
impacts.
EPA's
commitment
to
address
this
issue
is
described
by
Project
6
in
Section
VII
B
of
today's
notice
Participate
in
an
Incident
Tracking
Workshop
and
Project
7
Conduct
Exposure
Measurement
Workshop.
A
description
of
these
two
projects
as
it
appeared
in
today's
FR
notice
is
given
below
since
they
answer
many
of
the
comments
received
on
this
topic.

Project
6:
Participate
in
an
Incident
Tracking
Workshop
USEPA,
2003d
78
One
of
the
highest
research
priorities
identified
by
the
NRC
and
participants
at
the
July
2003
WERF
Biosolids
Research
Summit
is
the
need
for
rapid
response
investigations
of
reported
health
effects
potentially
resulting
from
land
application
practices.
EPA
also
received
many
public
comments
urging
development
of
an
incident
tracking
and
response
process.
The
Agency
agrees
that
developing
an
incident
tracking
program
is
important.
However,
the
Agency
believes
that
it
should
not
develop
an
incident
monitoring
program
on
its
own,
but
should
include
various
stakeholders
who
have
had
experiences
with
incidents
related
to
sewage
sludge,
stakeholders
who
may
be
interested
in
participating,
and
those
who
have
the
expertise
and
should
take
part
in
helping
to
develop
such
a
program.
As
stated
above,
stakeholders
who
have
had
experiences
with
reported
incidents
related
to
land
application
of
sewage
sludge
should
be
consulted.
A
program
of
incident
monitoring
and
investigation
could
be
modeled
after
an
existing
program.
Once
such
organization
that
has
experience
with
such
incidents
is
the
State
of
North
Carolina
(
NC).
The
North
Carolina
Department
of
Environment
and
Natural
Resources
is
responsible
for
environmental
programs
in
the
state,
including
biosolids
and
residuals
management.
One
purpose
of
the
program
is
to
assure
timely
and
meaningful
response
to
perceived
and
actual
environmental
incidents.
The
experiences
of
NC
and
others
could
be
helpful
in
developing
such
a
program
and
determining
the
next
steps.

In
order
to
respond
to
reported
incidents
of
human
illnesses
and
adverse
health
effects
alleged
to
have
been
caused
by
land
application
of
sewage
sludge,
and
to
determine
the
appropriate
next
steps
in
the
process,
EPA
believes
that
local
and
State
health
agencies,
in
addition
to
other
Federal
health
agencies,
such
as
the
Center
for
Disease
Control
and
Prevention
(
CDC),
are
positioned
best
and
have
the
necessary
expertise
to
respond
to
allegations
of
adverse
health
effects
following
use
or
disposal
of
sewage
sludge.
However,
EPA
is
committed
to
participating
in
activities
related
to
this
issue
and
plans
to
participate
in
the
incident
tracking
workshop
with
WERF
and
other
stakeholders
in
developing
the
research
concepts
and
methods,
and
in
interpreting
and
summarizing
results.

The
first
step
in
the
process
will
take
place
when
WERF
assembles
stakeholders
in
a
workshop
to
be
held
in
2004.
EPA
will
participate
in
the
workshop,
which
will
begin
evaluating
the
next
steps
for
investigating
adverse
human
health
allegations
following
land
application
of
sewage
sludge.
Ultimately,
the
objective
is
to
determine
whether
such
reported
symptoms
of
illness
can
be
attributed
to
the
land
application
of
sewage
sludge.
The
Cornell
Waste
Management
Institute
(
CWMI)
has
collected
over
300
incidents
over
the
past
several
years
in
which
residents
living
near
sites
where
sewage
sludge
has
been
applied
have
reported
illness
(
Cornell
Waste
Management
Institute,
2003;
Harrison
and
Oakes,
2002).
However,
the
CWMI
states
that
it
has
not
been
confirmed
by
scientific
investigation
that
illnesses
have
resulted
from
land
application
of
sewage
sludge.
The
information
provided
by
the
CWMI
may
be
useful
as
stakeholders
begin
to
plan
for
a
workshop
to
address
such
incidents.

This
process,
starting
with
the
multi­
stakeholder
workshop,
will
take
place
at
least
through
FY
2005.
Additional
activities
beyond
that
time
frame
will
depend
on
the
outcome
of
the
workshop,
work
with
local,
State
and
Federal
agencies,
as
well
as
other
stakeholders
and
USEPA,
2003d
79
availability
of
resources.
Additional
activities
may
include
participating
in
subsequent
stakeholder
meetings
or
workshops
and
deciding
on
additional
activities
and
next
steps.

Project
7:
Conduct
Exposure
Measurement
Workshop
The
purpose
of
this
workshop
is
to
identify
exposure­
related
research
priorities.
This
workshop
is
meant
to
compliment
the
objectives
of
the
WERF
workshop
(
see
Project
6)
or
be
a
related
follow­
up
activity
that
is
structured
around
issues
and
ideas
identified
in
the
WERF
workshop.
Workshop
discussions
will
focus
on
exposure
measurement
tools
that
researchers
or
health
agencies
can
use
to
investigate
reports
of
adverse
human
health
effects
from
land
application
of
sewage
sludge.
The
discussions
and
tools
will
focus
on
scientific
uncertainties
related
to:
(
1)
which
particular
sewage
sludge
contaminants
or
combinations
of
contaminants
may
be
potentially
responsible
for
disease
outbreaks;
(
2)
how
affected
individuals
are
exposed
to
these
contaminants;
(
3)
how
sewage
sludge
treatment
and
management
practices
can
reduce
potential
risks,
and
(
4)
how
good
analytical
methods
and
monitoring
have
to
be
to
obtain
satisfactory
answers.
The
workshop
will
explore
such
topic
areas
for
identifying
research
priorities
as
methods
development,
ambient
measurements
(
including
spatial
and
temporal
monitoring
requirements),
fate
and
transport
modeling,
and
exposure
measurements,
including
identifying
the
specific
exposure
routes
(
e.
g.,
oral
and
inhalation),
exposure
pathways
(
e.
g.,
eating
food,
drinking
water),
and
contaminants.

Workshop
participants
would
include
representatives
from
EPA;
other
Federal,
State
and
local
agencies;
academia;
wastewater
utilities;
environmental
groups;
industry;
and
citizen
groups.
Participants
would
identify
and
possibly
prioritize
what,
when,
and
where
measurements
should
be
taken,
and
how
they
should
be
taken
during
rapid
response
investigations.
EPA
will
develop
a
report
to
summarize
discussions
and
identify
the
exposure
research
tools
needed
to
investigate
reported
incidents
of
exposure.
Pending
the
results
from
a
similar
effort
being
sponsored
by
WERF
and
in
which
EPA
will
participate
(
Project
6),
we
expect
to
hold
this
workshop
in
2004.

Note:
many
of
the
following
comments
deal
with
local
allegations
of
human
health
impacts
from
the
land
application
of
sewage
sludge.
EPA
cannot
respond
to
these
comments
on
these
local
situations
since
for
the
most
part,
EPA
personnel
have
not
investigated
these
specific
local
allegations
of
human
health
impacts.
However,
it
is
these
types
of
local
situations
that
will
be
investigated
using
the
newly
developed
protocols
for
incident
reporting.

Academia
EPA
Log
#
51:
Ellen
Z.
Harrison
Comment
The
NRC
report
reviewed
all
the
available
literature
pertaining
to
health
studies.
The
report
found
that
in
studies
of
wastewater
treatment
plant
(
WWTP)
and
biosolids
workers,
there
are
a
mix
of
results.,
some
showing
illness
response
and
some
not.
At
the
time
the
NRC
report
was
drafted
there
was
not
a
single
study
of
the
health
of
neighbors
at
sites
where
illness
was
reported.
The
NRC
committee
clearly
recognized
that
a
lack
of
evidence
does
not
represent
USEPA,
2003d
80
evidence
of
a
lack
of
effect.
That
is
why
the
committee
strongly
endorsed
investigations
of
the
reported
incidents
of
illness.

EPA
proposes
no
health
studies
and
no
surveillance
of
health
around
land
application
sites.
They
propose
to
"
conduct
a
dialogue
with
other
health­
based
Federal
agencies 
on
the
possibility
of
cooperatively
tracking
incident
reports."
(
p
17384).

EPA
suggests
that
they
have
conducted
or
are
conducting
studies
on
the
occurrence
of
disease
(
p.
17389),)
but
none
have
been
done
or
are
being
done
to
my
knowledge
(
and
I
have
been
very
involved
with
EPA
and
others
in
this
area
so
I
would
expect
to
know
of
any
such
studies)
and
none
are
discussed
further
in
the
April
9
document.
The
document
refers
back
to
the
section
on
Risk
Assessment
and
Human
Health
and
states
that
their
primary
objective
is
"
to
characterize
pollutants
and
microbial
agents
present
in
biosolids,
as
well
as
any
associated
human
health
exposure
pathways "

This
is
not
the
type
of
human
health
studies
called
for
by
NRC.
EPA
recognizes
that
"
the
NRC
sees
an
immediate
need
for
a
systematic
approach
for
investigating
claims
of
disease
or
illness"
(
p.
17390).
EPA
proposes
to
"
investigate
the
possibility
of
developing
a
process
for
"
notification
and
tracking.
This
is
not
responsive
to
the
NRC
recommendation.
Keeping
track
is
necessary,
but
not
sufficient.
Investigating
the
possibility
of
a
process
is
not
even
committing
to
keeping
track.

In
work
done
at
the
Cornell
Waste
Management
Institute
(
CWMI),
research
was
done
to
determine
what
investigation
of
illness
reports
was
done
by
EPA
and
by
the
states
and
local
agencies
(
Harrison
and
Oakes,
2003).
The
findings
were
that
no
systematic
investigations
of
the
health
complaints
were
conducted.
The
results
of
our
investigation
and
work
published
subsequent
to
the
drafting
of
the
NRC
report
(
Lewis
et
at,
2002)
make
it
reasonable
to
believe
that
in
some
circumstances
neighbors
are
getting
ill
from
land
application
of
sludges.
This
makes
the
investigation
of
such
reports
imperative.
Since
not
all
land
application
sites
seem
to
be
causing
illness,
the
investigations
must
be
directed
to
those
problem
sites.
One
of
the
problems
with
the
Pennsylvania
study
is
that
it
is
not
addressing
such
sites.
Rather
it
is
an
experiment,
applying
sludges
to
small
areas
once
and
these
are
not
sites
at
which
neighbors
have
reported
symptoms.

The
U
AZ
and
the
USDA/
EPA/
PA
studies
are
mischaracterized
in
the
April
9
document
as
evaluating
risk
(
p.
17390).
They
are
simply
monitoring
of
selected
pollutants
and
bioaerosols.
There
is
a
critical
need
to
respond
immediately
to
reported
illnesses
associated
with
land
application
of
sludges
to
determine
whether
sludge
is
the
probable
cause.
There
is
a
need
to
determine
what
types
of
sludges
and
management
practices
are
associated
with
illness.
None
of
the
current
or
planned
research
addresses
these
issues.

Response
Please
see
the
Summary
Response
to
this
section.
NRC
recognized
the
need
to
investigate
allegations
of
health
incidents
from
exposure
to
biosolids
and
EPA
has
responded
by
developing
two
specific
projects
for
tracking
health­
related
complaints
about
biosolids.
EPA
recognizes
the
value
of
the
CWMI
work
on
the
Investigation
of
Alleged
Health
Incidents
Associated
with
Land
Application
of
Biosolids
(
Harrison
and
Oakes,
2002)
and
the
recognition
USEPA,
2003d
81
by
the
commenter
that
these
incidents
are
not
necessarily
due
to
land
application
of
sewage
sludge.
The
information
provided
by
the
CWMI
will
be
useful
as
a
first
step
in
tracking
reported
health
incidents
and
in
developing
tools
that
researchers
or
health
agencies
can
use
to
investigate
reports
of
adverse
human
health
effects
from
land
application
of
sewage
sludge.

Citizens
EPA
Log
#
8:
David
A.
Burrows
Comment
The
NRC
recommended
epidemiological
studies
(
Federal
Register
p.
17390)
would
be
of
broader
scope
and
thus
preferable
to
targeted
human
health
studies.

Response
NRC
also
recognized
that
complete
epidemiological
studies
are
expensive
and
require
extensive
data
analysis
(
top
of
p.
7
of
NRC
report).
An
epidemiological
study
could
help
answer
many
questions
regarding
cause
and
effect
associated
with
land
applied
sewage
sludge.
However,
EPA
believes
that
a
more
practical
and
affordable
approach
to
characterize
human
health
impacts
and
that
would
yield
results
in
a
more
timely
manner
would
be
from
the
two
projects
described
in
the
Summary
Response.
For
that
reason,
EPA
at
this
time
does
not
support
epidemiological
studies.

EPA
Log
#
11:
Loudon
Neighbors
Against
Toxic
Sludge
(
NATS)

Comment
EPA
must
address
the
serious
health
problem
that
threatens
rural
populations
in
my
state
of
Virginia
and
at
least
twenty
other
states:
the
stockpiling
and
land
application
of
limed
Class
B
municipal
sewage
sludge
near
residential
areas.
This
problem
has
also
spread
to
suburban
and
urban
areas,
which
apply
EQ
sludges
to
parks,
school
fields,
recreational
areas,
and
public
gardens.

Overwhelming
anecdotal
evidence
as
well
as
documented
evidence
in
peer
reviewed
technical
and
medical
journals
indicate
that
people
exposed
to
land
applied
sludge
are
getting
ill.
Even
deaths
have
been
linked
to
this
practice.
The
national
press
has
focused
on
the
issue
and
victims
are
finally
being
heard.

In
1997,
the
Cornell
Waste
Management
Institute
issued
a
warning
that
the
current
rules
that
govern
this
practice
are
not
protective
of
human
health,
agricultural
productivity
or
the
environment.

Response
Please
see
the
Summary
Response
to
this
section
and
EPA
response
to
EPA
Log
No.
51
in
this
section.

EPA
Log
#
29:
Henry
J.
Staudinger
Comment
F.
EPA's
Human
Health
Strategy
is
Not
Adequate.
USEPA,
2003d
82
NRC
Recommends
that
EPA
conduct
response
incident
investigations,
targeted
exposure
surveillance
and
epidemiological
investigations
of
exposed
populations
to
document
the
extent
to
which
health
complaints
can
be
linked
to
biosolids
exposure.

EPA
rejects
NRC's
recommended
epidemiological
investigations
of
exposed
populations,
claiming
that
the
agency's
primary
objective
is
to
characterize
pollutants
and
microbial
agents
present
in
biosolids,
but
says
it
is
willing
to
consider
developing
a
process
for
timely
notification,
recording,
and
tracing
incident
reports
and
targeted
studies.

As
set
forth
above,
EPA's
decision
not
to
develop
a
comprehensive
list
of
pollutants
or
to
reasonably
measure
maximum
exposure
rate
means
that
EPA
will
leave
human
health
protection
largely
to
chance.
The
USDA/
EPA/
DEP
project
referred
to
by
EPA
confirms
the
limitations
of
this
strategy.

Until
EPA
scientifically
documents
that
the
health
and
right
to
life
of
sensitive
individuals
such
as
the
severe
immune
compromised
will
not
be
adversely
affected
by
exposure
to
biosolids,
EPA
must
prohibit
exposure
of
those
individuals
to
biosolids.

2.
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.

Timely
notification,
recording
and
tracking
incident
reports
are
a
critical
part
of
any
effort
to
understand
the
risks
associated
with
biosolids.
EPA
must
develop
such
a
process,
not
simply
"
investigate
the
possibility"
of
doing
so.
This
information
is
critical
in
any
effort
to
identify
the
causal
relationship
between
biosolids
and
adverse
public
health.
This
should
be
followed
up
with
a
nationwide
data
base
accessible
to
everyone.

Response
See
the
Summary
Response
to
this
section
and
EPA
response
to
Log
No.
8
in
this
section.
NRC
recognized
that
complete
epidemiological
studies
are
expensive
and
require
extensive
data
analysis
(
top
of
p.
7
of
NRC
report).
EPA
believes
that
a
more
practical
and
affordable
approach
to
characterize
human
health
impacts
and
that
would
yield
results
in
a
more
timely
manner
would
be
from
the
two
projects
described
in
the
Summary
Response.
EPA
is
committed
to
developing
and
implementing
such
a
system
called
for
in
the
last
paragraph
of
these
comments.

EPA
Log
#
31:
David
L.
Lewis
Comment
Denunciation
of
"
sludge
victims"
The
NRC
report,
and
our
own
research
as
well,
calls
for
epidemiological
studies
of
health­
related
complaints
from
residents
living
close
to
land­
applications
sites.
Synagro,
on
the
other
hand,
simply
denounces
residents
who
report
adverse
health
effects.
According
to
the
company,
all
they
suffer
from
is
mass
hysteria,
which
can
be
traced
back
to
the
18th
Century
when
people
lived
in
fear
of
"
unseen
evils"
and
believed
in
"
demons
and
spirits."
If
this
were
not
silly
enough,
Synagro
USEPA,
2003d
83
argues
that
the
"
so­
called
sludge
victims"
should
bear
the
burden
of
supporting
any
scientific
studies
on
sludge­
related
health
complaints.

Processing
sewage
sludge
such
that
it
will
remain
biologically
and
chemically
stable
in
the
field
(
not
produce
strong
odors)
increases
production
costs.
Synagro,
understandably,
has
a
strong
profit
motive
for
arguing
that
odor
cannot
cause
adverse
health
effects.
Nevertheless,
when
inadequately
treated
sewage
sludge
is
spread
over
large
areas,
the
odor
and
chemical
irritation
can
be
overwhelming.
Instead
of
conducting
research
to
better
identify
the
sources
of
these
problems
and
improve
the
practice,
Synagro
advises
EPA
to
continue
with
a
public
relations
campaign
to
convince
people
that
sewage
sludge
does
not
smell
bad
and
that
people
exposed
to
it
experience
diarrhea
and
vomiting
because
they
are
uneducated.

In
my
first
expert
witness
report
submitted
in
Marshall
et
al
v.
Synagro
et
al
(
March
29,
2000),
I
suggested
that
such
adverse
effects
could
be
due
to
mixtures
of
irritant
inorganic
and
organic
chemicals,
such
as
ammonia,
trimethyl
amines,
lime,
and
bacterial
toxins
associated
with
windblown
dusts
and
volatile
emissions.
The
results
of
our
research
in
this
area
at
the
University
of
Georgia
were
first
presented
at
a
University
of
Maryland
conference
(
Lewis,
D.
L.,
et
al.
"
Enhanced
susceptibility
to
infection
from
exposure
to
gases
emitted
by
sewage
sludge:
A
case
study."
Biosolids
Management
in
the
21st
Century.
April
10­
11,
2000.
College
Park,
MD).
Schiffman
et
al
came
to
the
same
conclusions
as
we
did
(
J.
Agromedicine
Vol.
7(
1)
2000).
(
See
section
on
Schiffman
article
near
the
end
of
these
comments.)

Later,
we
published
a
study
of
residents'
complaints
(
Lewis,
D.
L.
et
al.
2002.
Interactions
of
pathogens
and
irritant
chemicals
in
land­
applied
sewage
sludges
(
biosolids)
BMC
Public
Health
2:
11
(
28
Jun).
We
found
that
the
most
common
complaints,
such
as
burning
eyes,
coughing,
respiratory
irritation,
and
difficulty
in
breathing,
are
not
always
associated
with
odor.

We
also
found
that
most
residents
began
complaining
about
strong
odors
and
adverse
health
effects
before
they
learned
that
the
source
of
the
odors
was
sewage
sludge.
Almost
without
exception,
residents
were
not
notified
when
sewage
sludge
was
applied,
and
warning
signs
were
not
posted
as
recommended
in
the
503
sludge
rule.

In
other
words,
initially,
these
residents
had
no
idea
what
was
causing
the
odors
or
the
irritation
they
experienced.
Synagro's
explanation
that
they
simply
exhibited
an
irrational
aversion
to
fecal
material,
therefore,
cannot
possibly
explain
their
complaints.

On
the
one
hand,
the
industry
wants
processed
sewage
sludge
to
be
called
biosolids,
a
term
residents
would
not
normally
associate
with
sewage.
However,
residents
exhibit
adverse
health
effects,
Synagro
attributes
them
to
an
irrational
aversion
to
fecal
material.
In
other
words,
"
Keep
the
public
ignorant
of
what
is
being
spread,
and,
if
they
complain,
call
them
ignorant."

Synagro's
portrayal
of
people
who
endure
unbearable
stench
and
ill
effects,
whether
perceived
or
real,
as
ignorant
and
irrational
reflects
a
condescending
attitude,
even
maliciousness.
Such
an
attitude
has
no
place
within
a
professional
scientific
debate.
It
does
nothing
to
advance
objective
USEPA,
2003d
84
investigations
that
could
identify
actual
problems
and
give
rise
to
better
processing
and
management
practices.

Synagro,
as
noted
earlier,
argued
that
the
burden
of
scientific
proof
should
"
fall
upon
those
making
allegations
of
illnesses
and
deaths,
the
`
so­
called
sludge
victims.'"
Residents
living
near
sludged
fields,
however,
already
bear
the
burden
of
being
taxed
to
pay
the
EPA
to
protect
public
health
and
the
environment.
Certainly,
the
tobacco
industry
would
be
less
regulated
and
more
profitable
if
people
with
heart
and
lung
disease
had
been
left
on
their
own
to
fund
any
independent
research.
The
same
is
true
of
victims
of
asbestos,
coal
dusts,
smog
and
other
industry­
related
public
health
problems.

Consistent
with
their
denunciation
of
people
who
report
adverse
health
effects,
Synagro
describes
scientists
who
suggest
a
link
to
adverse
health
effects
as
a
"
vocal
minority"
of
"
self­
interested
researchers."
How
can
anyone
not
laugh
when
a
commercial
business
argues
that
scientists
who
forfeit
their
jobs
and
reputations
for
criticizing
the
business
are
serving
their
self­
interests?
Or,
how
can
a
company
that
has
enjoyed
the
benefits
of
millions
of
dollars
in
taxpayers'
money
earmarked
to
promote
their
industry
complain
about
a
few
poor
scientists
for
voicing
their
opinions.

Contradictory
conclusions
set
forth
by
Synagro
include:

°
Complaints
of
adverse
health
effects
should
not
be
tracked.
If,
however,
EPA
does
track
them,
it
should
only
consider
complaints
initiated
by
a
treating
physician.
Residents
who
experience
"
a
painful
sensation
in
the
eyes
or
upper
respiratory
tract"
from
chemical
irritation,
however,
according
to
Synagro,
do
not
need
to
consult
a
physician
because
such
symptoms
are
"
not
severe
enough
to
require
medical
attention."

°
Illnesses
among
residents
exposed
to
sludge
should
not
be
investigated
because
meaningful
epidemiological
studies
cannot
be
done
on
residential
communities.
Such
populations,
they
argue,
are
too
small
and
"
epidemiologically
diverse"
to
yield
any
statistically
reliable
information.
On
the
other
hand,
Synagro
argues
that
the
1985
Ohio
study,
which
concluded
no
statistically
significant
adverse
health
effects
from
land
application,
is
a
reliable
epidemiological
study.

Never
mind
that
the
Ohio
study
was
largely
based
on
self­
reported
symptoms
by
residents
who
completed
questionnaires.
(
These
are
known
as
anecdotal
reports
in
studies
linking
adverse
health
effects
to
sewage
sludge.)
Also,
never
mind
that
many,
if
not
most,
of
the
residents
dropped
out
before
the
study
was
completed.

The
important
thing
to
remember,
industry
argues,
is
that
the
Ohio
study
included
an
unexposed
control.
Since
the
sewage
sludge
was
never
tested
for
pathogens,
however,
the
group
exposed
to
sludge
may
have
been
unexposed
to
pathogens
as
well.
It
appears
that
the
main
thing
that
makes
this
study
scientifically
sound
is
that
the
authors
concluded
that
pathogens
in
the
sludge
(
the
ones
that
weren't
measured
and
may
not
have
been
there)
did
not
infect
anyone.
USEPA,
2003d
85
Illnesses
among
workers
Synagro
dismisses
adverse
health
effects
from
land
applied
sewage
sludge
on
the
basis
that
workers
who
handle
sludge
are
more
highly
exposed
than
residents
and
workers
are
unaffected.
The
NRC
report
cites
a
number
of
studies
documenting
the
effects
of
bacterial
toxins
and
pathogens
on
workers
at
wastewater
treatment
plants.
Moreover,
many
residents
living
near
land
application
sites
are
more
susceptible
to
infection
and
are
exposed
for
longer
times
than
workers.

Furthermore,
emission
rates
of
airborne
contaminants
are
proportional
to
the
surface
area
of
sewage
sludge
exposed
to
the
atmosphere.
Sludge
spread
over
hundreds
to
thousands
of
acres
of
land,
therefore,
will
have
higher
emission
rates
than
sludge
confined
at
waste
treatment
plants.

It
is
also
important
to
recognize
that,
workers,
like
residents
and
scientists,
are
discouraged
from
reporting
illnesses.
While
few
workers
are
willing
to
risk
losing
their
jobs
by
discussing
this
problem,
one
exception
is
a
contractor
who
hauls
sewage
sludge
for
the
City
of
Wichita,
KS.
Before
my
research
at
EPA
ended,
he
wrote
to
me
and
gave
permission
to
publicly
distribute
his
letter
in
hopes
that
it
would
help
EPA
understand
the
plight
of
workers.

This
contractor,
who
reported
his
illnesses
to
NIOSH,
complained
of
recurring
E.
coli
infections
and
other
health­
related
problems
among
workers
hauling
sewage
sludge
and
debris
separated
from
the
sludge
("
grit").
He
explains
why
adverse
health
effects
among
workers
are
usually
not
investigated
or
documented.
(
See
reproduction
of
his
letter
below.)

(
Letter
has
been
omitted)

Response
EPA
thank
the
commenter
for
the
views
and
information
provided
which
will
be
considered
in
carrying
out
the
Agency
planned
activities.
EPA
believes
the
projects
described
in
the
Summary
Response
of
this
section
respond
positively
to
many
of
these
comments.
As
stated
in
the
response
to
EPA
Log
No.
8
in
this
section,
EPA
believes
that
a
more
practical
and
affordable
approach
to
characterize
human
health
impacts
and
that
would
yield
results
in
a
more
timely
manner
would
be
from
the
projects
described
in
the
Summary
Response
to
this
section.
For
that
reason,
EPA
at
this
time
does
not
support
epidemiological
studies.
Finally,
EPA
values
the
data
and
study
results
from
all
researchers
and
stakeholders
as
long
as
this
information
meets
the
standards
of
EPA's
Data
Quality
Guidelines.

EPA
Log
#
33:
Citizens
for
Sludge­
Free
Land
(
CFSL)

Comment
CFSL
agrees
with
Synagro
Technologies
Inc.
that
the
references
in
the
NRC
report
failed
to
include
important
studies.
For
example,
the
NRC
report
failed
to
reference
the
groundbreaking
research
of
University
of
Georgia
scientists
that
document
the
links
between
land
application
and
adverse
health
effects
in
peer
reviewed
medical
and
technical
journals.
This
omission
is
especially
egregious
because
much
of
the
information
and
many
of
the
recommendations
in
the
University
of
Georgia
research
were
incorporated
in
the
report,
without
giving
the
authors
credit.
Likewise,
the
EPA
Response
does
not
give
credit
to
these
researchers
and
their
recommendations.
USEPA,
2003d
86
Response
Please
see
the
response
to
Comment
log
No.
31.
All
relevant
information
will
be
considered.

EPA
Log
#
37:
David
A.
Burrows
Comment
EPA's
short
term
goal
is
grossly
insufficient
as
a
response
to
the
NRC's
overarching
recommendation
(
NRC
Report
page
6)
that
"
EPA
promote
and
support
response
investigations,
targeted
exposure
surveillance
studies,
and
a
few
well­
designed
epidemiological
investigations
of
exposed
populations."

On
page
17390
of
the
Federal
Register
the
EPA
shows
how
it
will
delay
doing
the
NRC
tracking
of
incident
where
human
illness
may
be
related
to
the
spreading
of
sewage
sludge
and
will
ignore
the
NRC
recommendation
to
conduct
"
a
few
well­
designed
epidemiological
investigations
of
exposed
populations."

On
page
17390
of
the
Federal
Register
EPA
states
"
The
Agency
is
investigating
the
possibility
of
developing
a
process
for
timely
notifications,
recording,
and
tracking
incident
reports
in
collaboration
with
the
Center
for
Disease
Control
and
Prevention
(
CDC)."
The
Agency
has
initiated
preliminary
discussion
with
CDC
to
discuss
possible
mechanisms
for
recording
and
tracking
biosolids
related
disease
incidents."
This
is
bureaucratic
footdragging
and
reflects
poorly
on
EPA.

Response
Please
see
the
Summary
Response
to
this
section
and
EPA
response
to
Log
No.
8.

EPA
Log
#
40:
Thomas
F.
Albert
Comment
Comment
#
4:
On
page
I7384
EPR's
principal
health
related
short
term
goal
(
goal
#
7)
is
listed
last.
Why
is
the
only
clearly
health
related
short
term
goal
listed
LAST?
When
discussing
its
overarching
recommendations
the
NRC
report
(
page
5)
calls
clear
attention
to
the
need
for
EPA
to
CONDUCT
health
related
studies.
To
be
specific
regarding
its
overarching
recommendations
the
NRC
report
on
page
5
states
"
Because
of
the
anecdotal
reports
of
adverse
health
effects,
the
public
concerns,
and
the
lack
of
epidemiological
investigation,
the
committee
concluded
that
EPA
should
conduct
studies
that
examine
exposure
and
potential
health
risks
to
worker
and
residential
populations."

Comment
#
5:
On
page
17384
EPA's
short
term
goal
#
7
is
health
related
and
specifically
Mentions
"
tracking
incident
reports
and
investigating
whether
adverse
human
health
outcomes
can
be
associated
with
biosolids
exposure.
"
This
is
exactly
the
type
of
health
related
research
that
sludge
impacted
people
are
calling
for.
Why
is
this
listed
as
the
last
of
EPA's
short
term
goals?
Why
isn't
this
the
FIRST
of
the
short
term
goals?
Unfortunately,
EPA
not
only
lists
this
LAST
among
its
short
term
goals,
but
EPA
also
puts
2
"
weasel
words"
into
goal
#
7
that
clearly
show
its
low
priority
and
show
that
nothing
will
be
done
soon.
By
"
weasel
words"
I
mean
that
EPA
says
that
it
will
"
conduct
a
dialogue"
with
other
health
based
Federal
agencies.
Why
"
conduct
a
dialogue"?
Why
not
just
go
and
do
it?
Another
example
of
"
weasel
wording"
in
goal
#
7
is
that
USEPA,
2003d
87
the
"
dialogue"
will
be
concerned
with
the
"
possibility
of
cooperating
tracking
incident
reports."
Why
only
"
dialogue"
about
the
"
possibility"
of
cooperative
tracking?
The
way
that
short
term
goal
#
7
is
stated
it
seems
clear
that
EPA
gives
a
VERY
LOW
PRIORITY
to
tracking
down
sludge
related
health
complaints.

Comment
#
6:
EPA's
last
listed
short
term
goal
(
goal
#
7)
is
so
"
weasel
worded"
that
it
seems
clear
that
EPA
has
no
intention
of
addressing
the
NRC
report's
primary
Health
Finding
(
page
6
NRC
report)
and
the
related
NRC
report
recommendation
(
NRC
report
Page
6).
The
NRC
report's
first
Health
Finding
(
listed
on
page
6
of
NRC
report)
s
quite
clear
"
There
is
a
lack
of
exposure
and
health
information
on
populations
exposed
to
biosolids."
What
can
be
clearer
than
this?
The
NRC
finding
further
states
"
EPA
needs
to
study
more
rigorously
the
exposure
and
health
risks,
or
lack
thereof,
in
worker
and
community
populations
exposed
to
biosolids."
(
NRC
report
page
6).
The
NRC
report
recommendation
that
follows
this
Health
Finding
is
also
very
direct
"
the
committee
recommends
that
EPA
promote
and
support
response
investigations,
targeted
exposure
surveillance
studies,
and
a
few
well­
designed
epidemiological
investigations
of
exposed
populations."
How
can
EPA's
short
term
goals
pretend
to
respond
to
the
NRC
report's
overarching
health
related
recommendation?

Comment
#
7:
EPA's
7
short
term
goals
(
page
17384)
DO
NOT
COME
CLOSE
TO
RESPONDING
TO
THE
NRC
REPORT'S
HEALTH
RELATED
OVERARCHING
RECOMMENDATION.
Why
do
EPA's
short
term
goals
not
properly
address
the
human
health
issue?
If
Class
B
sewage
sludge
applied
to
land
posed
no
human
health
threat,
why
wouldn't
EPA
quickly
design
and
conduct
the
studies
to
document
"
no
effect"?
The
obvious
reluctance
by
EPA
to
promptly
conduct
suitable
health
related
studies
should
make
a
reasonable
person
even
more
concerned
about
the
health
effects
of
land
applied
Class
B
sewage
sludge.
Are
the
thousands
of
sludge
impacted
people
lying?
Are
their
health
related
fears
groundless?
Why
does
EPA
not
want
to
conduct
proper
health
related
studies
as
called
for
by
the
NRC
report
(
such
as
on
NRC
report
pages
4­
6)?

Comment
#
8:
The
last
sentence
in
the
"
Major
Short­
Term
Goals
and
Priority
Actions
During
FY03
and
FY04
section
is
MISLEADING.
The
sentence
(
page
17384)
states
"
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."
Unfortunately,
it
is
not
clear
whether
this
apparent
"
bottom
line"
type
statement
pertains
only
to
short
term
goal
#
7
or
to
all
of
the
short
term
goals.
The
statement
is
misleading
because
the
short
term
goals,
even
as
a
group,
do
not
reasonably
respond
to
the
NRC
report's
primary
health
related
recommendation
(
NRC
report
page
6).
That
NRC
recommendation
urges
that
"
EPA
promote
and
support
response
investigations,
targeted
exposure
surveillance
studies,
and
a
few
well­
designed
epidemiological
investigations
of
exposed
populations."
The
NRC
report
continues
by
stating
"
This
recommendation
is
intended
to
provide
a
means
of
documenting
whether
health
effects
exist
that
can
be
linked
to
biosolids
exposure."
None
of
the
short
term
goals
directly
state
that
EPA
will
support
response
investigations
or
targeted
surveillance
studies
or
epidemiological
studies.
EPA
knows
that
thousands
of
sludge
impacted
people,
just
like
the
NRC
report,
are
calling
for
such
studies.
Why
aren't
such
specific
efforts
part
of
EPA's
short
term
goals?
USEPA,
2003d
88
Comment
#
9:
On
page
17384
EPA
lists
4
"
Major
Longer­
Term
Goals
and
Future
Priorities
(
FY05
and
Beyond)."
The
second
sentence
is
MISLEADING.
The
misleading
sentence
states
"
The
following
priority
areas
are
aimed
at
implementing
recommendations
for
reducing
the
potential
for
public
health
impact."
How
can
such
a
statement
be
true
when
none
of
the
longer
term
goals
specially
address
the
primary
health
effects
recommendation
as
stated
on
page
6
of
the
NRC
report?
That
primary
health
effects
recommendation
of
the
NRC
report
urges
EPA
to
"
promote
and
support
response
investigations,
targeted
exposure
surveillance
studies,
and
a
few
well­
designed
epidemiological
investigations
of
exposed
populations."
Not
one
of
the
EPA's
long
term
goals
specifically
responds
to
this
NRC
recommendation.
Why
does
EPA
seem
to
avoid
responding
to
this
NRC
recommendation?
If
EPA
was
truly
responding
to
the
NRC
report's
primary
health
effects
recommendation
(
as
stated
on
page
6
of
NRC
report),
the
EPA
goals
(
short
term
and
long
term)
would
specifically
call
for
such
health
related
studies.

Comment
#
30:
On
page
17390
is
the
VERY
BRIEF
section
"
F.
Human
Health
Studies."
Why
is
the
human
health
study
section
so
brief?
Why
isn't
this
section
FIRST?
In
EPA's
comments
it
divides
its
responses
to
the
NRC
recommendations
into
8
categories
(
these
are
categories
A­
H).
Of
the
8
categories
of
EPA
responses,
only
one
category
is
shorter
than
the
Human
Health
Studies
section.
In
responding
to
the
NRC
recommendations;
1)
why
does
EPA
list
the
Human
Health
Studies
category
near
the
end
of
its
listing
(
it
is
#
6
of
8
categories),
and
2)
why
does
EPA
devote
so
little
space
to
the
Human
Health
Studies
category
(
only
one
of
the
8
categories
is
shorter
in
length)?

Comment
#
31:
As
noted
above
EPA's
Human
Health
Studies
section
is
very
brief
and
appears
on
page
17390.
As
earlier
noted
EPA
has
its
Human
Health
Studies
section
"
near
the
end
of
its
list",
that
is,
this
category
appears
as
the
sixth
category
of
EPA's
8
categories
of
responses
to
the
NRC
recommendations.
One
should
ask,
why
aren't
Human
Health
Studies
listed
as
EPA's
#
1
category
when
responding
to
the
NRC
report's
recommendations?
Regarding
human
health
matters
in
relation
to
sewage
sludge,
it
is
instructive
to
see
how
the
Summary
section
of
the
NRC
report
handles
this
matter.
In
the
NRC
report
Summary,
just
after
the
Overarching
Recommendations,
is
the
Health
Effects
section
and
in
that
section
the
very
first
recommendation
calls
upon
EPA
to
conduct
health
studies
(
see
page
6
of
NRC
report).
One
can
reasonably
ask,
since
the
NRC
report's
Summary
has
its
Health
Effects
section
first
after
the
Overarching
Recommendations,
why
then
does
EPA
place
Human
Health
Studies
as
category
#
6
of
its
8
categories
of
response
to
the
NRC
recommendations?
This
question
seems
even
more
appropriate
when
one
recognizes
that
in
the
NRC
report
Summary's
Health
Effects
section
the
first
recommendation
is
a
call
for
health
studies.
That
recommendation
on
page
6
of
the
NRC
report
is
very
clear
and
explicit
"
the
committee
recommends
that
EPA
promote
and
support
response
investigations,
targeted
exposure
surveillance
studies,
and
a
few
well­
designed
epidemiological
investigations
of
exposed
populations."
The
NRC
committee
further
stated,"
This
recommendation
is
intended
to
provide
a
means
of
documenting
whether
health
effects
exist
that
can
be
linked
to
biosolids
exposure."
Again,
WHY
does
EPA
have
this
health
studies
section
so
far
down
its
"
list"?

Comment
#
32:
On
page
173190
EPA
devotes
very
little
space
(
43
lines)
as
to
how
EPA
plans
to
address
NRC
human
health
studies
recommendations.
This
very
brief
"
plan"
proposed
by
EPA
is
USEPA,
2003d
89
INADEQUATE
and
nearly
useless.
It
does
show
2
things
reasonably
clearly;
1)
EPA
plans
to
IGNORE
the
NRC
recommendation
to
conduct
epidemiological
studies,
and
2)
EPA
goes
to
some
length
to
show
how
it
will
DELAY
even
doing
the
NRC
recommended
tracking
of
incidents
where
human
illness
may
be
related
to
spreading
sewage
sludge.
Of
the
brief
"
plan"
by
EPA
to
address
the
NRC
human
health
studies
recommendations
it
is
interesting
to
see
that
it
is
rather
neatly
divided
into
3
parts.
Part
#
1
(
16
lines)
gives
WEAK
EXCUSES
as
to
why
EPA
will
IGNORE
THE
NRC
RECOMMENDATION
to
conduct
"
a
few
well­
designed
epidemiological
investigations
of
exposed
populations."
Part
#
2
of
the
EPA
plan
(
15
lines)
does
Not
say
that
EPA
will
do
the
NRC
recommended
health
incident
tracking
type
studies.
Rather,
in
Part
#
2
of
its
plan,
EPA
gets
very
vague
as
it
will
"
investigate
the
possibility",
and
it
has
"
initiated
preliminary
discussions
with
CDC",
and
it
will
apparently
discuss
"
possible
mechanisms
for
recording
and
tracking
biosolids
related
disease
incidents."
(
Why
all
the
use
of
"
investigate",
"
possibility",
"
initiate",
"
preliminary",
and
"
possible"?
Doesn't
this
sound
like
delay,
delay,
delay?
Part
#
3
of
the
EPA
plan
(
12
lines)
just
extolls
the
virtues
of
a
University
of
Arizona
study
and
how
it
may
interact
with
often
mentioned
(
and
over
rated)
cooperative
sludge
study
in
Pennsylvania
conducted
by
EPA/
USDA/
PA
DEP.

Comment
#
33:
As
noted,
EPA
plans
to
devote
very
little
effort
to
addressing
NRC
human
health
studies
recommendations
(
see
the
43
lines
on
page
17390).
EPA
plans
to
IGNORE
the
NRC
recommendation
to
conduct
"
a
few
well
designed
epidemiological
investigations
of
exposed
populations."
As
noted
earlier
the
NRC
recommendation
is
part
of
the
NRC
committee's
very
first
recommendation
regarding
Health
Effects
(
see
page
6
of
NRC
report).
If
EPA
plans
to
ignore
this
NRC
recommendation,
EPA
should
provide
better
reasoning
rather
than
the
WEAK
EXCUSE
(
16
lines)
it
presents
on
page
173190.
To
the
thousands
of
sludge
impacted
people
who
call
for
health
related
studies,
this
EPA
decision
reinforces
the
opinion
of
many
that
EPA
is
AFRAID
of
what
such
studies
will
show.
If
this
is
not
the
case,
then
EPA
should
provide
concerned
citizens
with
a
well
reasoned
argument
(
not
a
16
line
excuse)
as
to
why
the
NRC
recommendation
should
be
ignored.

Comment
#
34:
As
mentioned
before
the
NRC
report
summary,
as
the
first
recommendation
regarding
Health
Effects,
calls
upon
EPA
to
conduct
health
studies.
On
page
6
of
the
NRC
report
"
the
committee
recommends
that
EPA
promote
and
support
response
investigations,
targeted
exposure
surveillance
studies,
and
a
few
well­
designed
epidemiological
investigations
of
expose
populations.''
On
page
17390
EPA
in
its
"
Targeted
Human
Health
Investigations"
section
(
all
of
14
lines)
more
or
less
"
beats
around
'
the
bush"
regarding
this
issue.
In
the
brief
section
EPA
DOES
NOT
commit
to
doing
such
studies.
Let
me
repeat
here
the
vague,
tentative
wording
that
EPA
uses,
"
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
discussion
with
CDC
to
discuss
possible
mechanisms
for
recording
and
tracking
biosolids
related
disease
incidents."
On
looking
at
these
2
quoted
sentences,
does
it
look
like
EPA
is
moving
ahead
to
address
the
NRC
recommendation
or
does
it
look
like
EPA
is
DELAYING?
Why
"
investigating
the
possibility",
why
not
just
do
it?
Why
"
preliminary
discussion",
why
not
real
discussion?
Conducting
health
incident
investigations
is
NOT
Rocket
SCIENCE.
EPA
presents
a
clear
picture
of
not
wanting
to
USEPA,
2003d
90
move
ahead
with
rather
simple,
straight
forward
incident
investigations.
This
timid,"
foot
dragging"
type
behavior
reflects
very
poorly
upon
the
agency
and
helps
reinforce
the
suspicions
of
many
sludge
impacted
people
that
EPA
doesn't
really
want
to
know
the
results
of
such
studies.
If
EPA
persists
in
avoiding
and/
or
delaying
such
NRC
recommended
health
studies
it
should
provide
a
reasoned
argument
(
not
14
lines)
as
to
why.

Response
Please
see
the
Summary
Response
to
this
section
for
a
description
of
specific
activities
EPA
will
undertake
to
track
reported
health
incidents
and
develop
exposure
measurement
tools
to
investigate
reports
of
adverse
human
health
effects
from
land
application
of
sewage
sludge.
On
the
conduct
of
epidemiological
studies,
please
see
response
to
comment
EPA
Log
No.
8.

EPA
Log
#
25:
Northumberland
Association
for
Progressive
Stewardship
(
NAPS)
Sewage
Sludge
Study
Group
Comment
F.
Human
Health
Studies
Lines
959­
990.
We
further
question
EPA's
resolve
in
gathering
scientific
data
when
it
says,"
At
this
time
(
funding
again),
the
Agency
does
not
plan
to
conduct
an
epidemiological
study,
as
discussed
in
the
NRC
report."
We
firmly
believe
that
without
epidemiological
studies,
we
cannot
determine
the
true
effect
of
sludge
carrying
pollutants
on
human
health.
Relying
on
only
a
limited
number
of
targeted
human
health
investigations
from
the
field
will
not,
in
our
opinion,
help
in
resolving
this
issue.

Response
As
stated
in
EPA
response
to
Log
No.
8,
EPA
does
not
believe
that
epidemiological
studies
are
the
best
use
of
EPA
resources
to
characterize
potential
health
risks
from
the
land
application
of
sewage
sludge.

Environmental
Groups
EPA
Log
#
7:
Sierra
Club
Comment
EPA
ignored
recommendations
from
Georgia's
EPD
in
1998
to
immediately
shut
down
Augusta's
sewage
sludge
land
application
program.
Now,
EPA's
Office
of
Research
&
Development
is
analyzing
data
indicating
that
hay
fertilized
with
Augusta
sludge
may
be
causing
infections
and
liver
damage
in
workers
using
it
for
erosion
control
along
state
roads
and
Interstate
highways.

Across
the
country,
hundreds
of
people
have
reported
that
their
health
and
quality
of
life
have
been
severely
impacted
by
land
application
of
sewage
sludge.
Sewage
sludges
are
mostly
disposed
of
in
areas
where
residents
lack
the
economic
and
political
means
to
protect
their
communities.
The
practice,
therefore,
disproportionally
impacts
poor
and
minority
communities.
Some
residents
have
filed
lawsuits,
seeking
damages
from
municipalities
and
private
companies
producing
and
applying
sewage
sludges.
Many
local
governments
have
restricted
or
banned
land
application.
USEPA,
2003d
91
Anecdotal
evidence
that
links
sludge
spreading
to
illnesses,
live
stock
damage,
and
groundwater
contamination
is
mounting.
The
Cornell
Waste
Management
Institute
has
been
documenting
cases
of
adverse
reactions
reported
by
people
exposed
to
land
applied
sewage
sludges.
The
NRC
recommended
that
EPA
address
the
growing
number
of
reports
of
health­
related
incidents
and
study
land
application
sites
generating
these
complaints.

Concurrent
with
the
publication
of
this
NRC
recommendation,
researchers
at
the
University
of
Georgia
linked
illnesses
and
deaths
among
residents
living
within
approximately
1
km
of
land
application
sites
to
exposure
to
certain
Class
A
and
Class
B
sludges,
especially
lime
stabilized
materials.
Individuals
using
private
wells
located
near
land
application
sites
report
chronic
diarrhea
and
vomiting
from
recurring
gastrointestinal
infections
involving
rotavirus
and
other
enteric
pathogens.
Most
complains,
however,
are
attributed
to
irritant
dusts
blowing
from
dry,
sludged
fields.
Symptoms
include
skin
rashes,
burning
eyes,
burning
throat,
burning
lungs,
persistent
cough,
and
difficulty
breathing.
These
symptoms
are
often
followed
by
opportunistic
infections
in
irritated
tissue
(
e.
g.,
sinus
and
throat
infections,
boils,
pneumonia),
which
may
be
life­
threatening.
Health
related
complaints
were
reported
even
when
the
applications
appeared
to
comply
with
EPA
guidelines
in
40CFR
Part
503.
The
NRC
panel
warned
that
effects
of
mixtures
of
chemical
and
pathogens
in
sludge
on
human
health
have
been
overlooked
and
should
be
addressed.
Nevertheless,
when
private
citizens
complain
of
adverse
health
effects,
they
are
often
threatened
with
litigation
by
the
leading
U.
S.
corporation
profiting
from
land
application.
Instead,
EPA
should
be
aggressively
investigating
these
complaints.

According
to
a
recent
Inspector
General
audit,
EPA
and
most
states
have
no
reliable
system
for
reporting,
tracking,
and
investigating
adverse
health
incidents
associated
with
land
application
of
sewage
sludge.
Responding
to
the
NRC's
recommendation
that
report
s
of
adverse
effects
be
investigated,
EPA
is
only
planning
to
"
investigate
the
possibility
of
developing
a
process
for
timely
notification,
recording,
and
tracking
incident
reports
in
collaboration
with
the
Centers
of
Disease
Control
&
Prevention
(
CDC)
(
19:
p.
17390)"
and
"
exploring
a
plan
to
conduct
a
molecular
pathogen
exposure
study"
involving
people
living
near
land
application
sites
who
develop
infections
(
19:
p.
17387).

The
Sierra
Club
recommends
that
EPA
take
a
much
more
active
role
in
alleviating
situations
where
people
living
near
land
application
sites
are
negatively
impacted.
Simply
"
investigating
the
possibility"
of
tracking
adverse
health
effects
and
"
exploring
a
plan"
to
track
sources
of
infections
in
people
coping
with
overwhelming
odors
and
sewage
sludge
dusts
in
their
homes
is
unacceptable.

Response
Please
see
the
Summary
Response
to
this
section.
EPA
recognizes
the
value
of
the
work
of
Cornell
Waste
Management
Institute
(
CWMI)
in
analyzing
and
synthesizing
the
reporting
of
health
incidents
from
land
application
of
sewage
sludge.
However,
CWMI
also
recognizes
that
it
has
not
been
confirmed
that
the
illnesses
recorded
were
due
to
land
application
of
sewage
sludge.
As
to
the
Georgia
case,
EPA
has
gathered
information
on
this
case.
EPA
has
found
no
evidence
that
exposure
to
land­
applied
sewage
sludge
was
the
cause
of
any
of
the
allegations
of
animal
or
human
deaths
cited.
USEPA,
2003d
92
EPA
Log
#
43:
Natural
Resources
Defense
Council
(
NRDC)

Comment
HUMAN
HEALTH
STUDIES
NRC
recommends
a
systematic
epidemiological
approach
to
evaluating
the
human
health
effects
of
biosolids
exposure
under
current
regulations.
NRC
recommends
studies
in
response
to
unusual
occurrences
of
disease
and
unusual
exposures,
preplanned
exposure
assessment
studies,
and
complete
epidemiological
studies
that
can
address
serious
or
widespread
problems.
EPA
rejects
the
NRC
approach
in
favor
of
more
limited
human
health
studies,
but
it
fails
to
identify
any
particular
"
targeted
"
studies
that
it
actually
plants
to
undertake.
EPA
claims
that
it
has
completed
and
continues
to
conduct
studies
on
exposure
and
disease
occurrence,
which
it
claims
are
described
in
the
Risk
Assessment
and
Human
Health
sections
of
the
comment.
Although
those
sections
discuss
a
generalized
intent
to
conduct
such
studies
in
the
future
and
make
reference
to
the
EPA/
USDA/
PA
site­
specific
project,
there
is
no
evidence
of
a
completed
or
ongoing
study
evaluating
the
occurrence
of
disease
or
other
human
health
effects
from
biosolids.
If
such
studies
exist,
they
need
to
be
explicitly
noted
and
made
available
to
the
public.

EPA's
stated
commitment
to
targeted
human
health
studies
also
appears
disingenuous.
In
contrast
to
NRC
'
s
recommendation
that
EPA
study
the
actual
human
effects
of
biosolids
exposure
by
establishing
a
framework
to
investigate
and
document
claims
of
disease
following
exposure,
the
Agency
states
that
its
"
primary
objective
"
is
to
merely
characterize
the
presence
of
pollutants
in
biosolids
and
the
pathways
by
which
human
exposure
may
occur.
EPA
acknowledges
NRC's
belief
that
there
is
an
"
immediate
need
for
a
systematic
approach
for
investigating
claims
of
disease."
Unfortunately,
EPA
does
not
commit
to
meeting
that
need.
Instead,
EPA
says
that
it
plans
to
investigate
"
the
possibility
of
developing
a
process
for
timely
notification,
recording,
and
tracking."
However,
even
this
extremely
tentative
effort
seems
unlikely
in
light
of
a
recent
statement
by
EPA
officials
that
"
investigating
health
impacts
from
biosolids
is
not
an
EPA
responsibility,"
but
rather
one
that
belongs
to
the
National
Institute
of
Occupational
Safety
and
Health
and
the
Centers
four
Disease
Control.
EPA's
statutory
responsibilities
to
protect
public
health
require
that
it
ensure
adequate
human
health
studies
are
being
conducted.
If
NIOSH
and
the
CDC
possess
superior
expertise
in
this
field,
then
EPA
should
ensure
that
the
President
directs
those
agencies
to
implement
the
NRC's
recommendations.
There
are
numerous
sludge
sites
across
this
country
that
have
been
identified
by
people
who
have
become
sick
as
the
likely
cause
of
their
illnesses.
EPA
owes
it
to
these
people
to
figure
out
whether
sludge
is
making
them
sick.
If
EPA
cannot
devote
the
resources
to
doing
so
or
arrange
for
CDC
or
NIOSH
or
another
public
health
agency
to
do
so,
it
must
ban
land
application
of
sludge
because
EPA
cannot
make
a
finding
that
the
regulations
are
"
adequate
to
protect
public
health
and
the
environment
from
any
reasonably
anticipated
adverse
effects."
33
U.
S.
C.
1345(
d)(
2)
&
(
3).

Response
Please
see
the
Summary
Response
to
this
section.
As
stated
before
in
the
response
to
EPA
Log
No.
8
in
this
section,
EPA
does
not
believe
that
epidemiological
studies
are
the
best
use
of
EPA
resources
to
characterize
potential
health
risks
from
the
land
application
of
sewage
sludge.
USEPA,
2003d
93
Municipal
Wastewater
Treatment
Plants
EPA
Log
#
24:
Hampton
Roads
Sanitation
District
(
HRSD)

Comment
Response
Team
for
Biosolids
Health
Report
HRSD
strongly
recommends
the
inclusion
of
Centers
for
Disease
Control
and
Prevention
for
investigating
all
claims
of
disease
or
illness
following
biosolids
exposure.
It
is
critical
that
a
third
party
with
no
allegiance
to
biosolids
fully
investigate
any
claims
of
illness
to
provide
a
level
of
confidence
to
the
public
that
the
investigation
is
unbiased.
In
Virginia,
citizens
have
criticized
the
state
regulators
for
announcing
their
support
of
biosolids
land
application.
Consequently,
these
citizens
are
quick
to
discredit
any
complaint
investigations
conducted
by
the
regulators;
especially
when
the
citizens
disagree
with
the
conclusions
of
the
investigations.

A
tracking
system
to
document
the
details
of
each
investigation
would
be
very
effective
to
ensure
that
the
information
is
accurately
distributed
to
all
interested
parties.
Relying
on
word
of
mouth
or
newsletter
summaries
tends
to
distort
the
findings
of
the
investigations.

Response
EPA
agrees
with
this
comment
on
the
inclusion
of
CDC
in
this
issue.
Please
see
the
summary
Response
of
this
section.
As
stated
before,
EPA
will
consider
and
evaluate
all
information
reported
from
stakeholders
as
long
as
this
information
can
be
verified
and
meet
the
standards
of
EPA's
Data
Quality
Guidelines.

EPA
Log
#
47:
Miami­
Dade
County
Water
and
Sewer
Depatment
(
MDWASD)

Comment
EPA's
plan
to
investigate
the
possiblity
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.

In
order
to
scientifically
determine
if
there
are
any
adverse
health
effects
from
the
land
application
of
biosolids,
there
must
be
a
way
for
rapid
communication
between
health
organizations,
regulatory
agencies,
and
potentially
affected
members
of
the
public.
MDWASD
encourages
the
EPA
to
investigate
the
feasibility
of
such
a
communication
method,
such
as
developing
a
real
time
web
site
that
various
agencies
could
share
as
a
research
and
tracking
tool.
Working
with
such
health
based
organizations
such
as
the
Center
for
Disease
Control
and
Prevention
is
an
essential
component
to
filling
the
data
gaps
of
biosolid
use
and
health
effects.

Response
EPA
agrees
with
these
comments.

Land
Application
Company
EPA
Log
#
26:
Synagro
Technologies,
Inc.

Comment
DEVELOP
A
METHOD
TO
INVESTIGATE
AND
TRACK
COMPLAINTS
INVOLVING
HUMAN
HEALTH
EFFECTS
FROM
NEARBY
LAND
APPLICATION
SITES.
USEPA,
2003d
94
Small­
scale,
geographic
based
health
investigations
have
always
been
hampered
because
residential
populations,
like
those
around
biosolids
land
application
sites,
are
too
small
to
yield
the
statistical
power
necessary
to
exhibit
robust
correlations.
Additionally,
the
case
is
that
such
populations
are
too
epidemiologically
diverse
to
conduct
a
reliable
study
of
health
effects.

A
number
of
complications
make
it
difficult,
if
not
impossible,
to
single
out
treated
biosolids
as
a
causative
agent.
For
example,
the
expert
panel
points
out
that
there
is
no
currently
existing
reliable
exposure
metric
because
biosolids
are
not
unique
materials.
All
of
the
microorganisms
and
chemicals
found
in
biosolids
are
found
elsewhere,
often
in
higher
concentrations.
Thus,
it
is
difficult
to
link
the
presence
of
a
particular
chemical
or
microorganism
found
in
a
receptor
with
the
occurrence
of
that
organism
or
chemical
in
biosolids
without
ruling
out
all
possible
confounders.

EPA
should
not
allocate
resources
in
an
attempt
to
develop
a
new
model
to
investigate
and
track
complaints
of
human
health
effects
from
nearby
biosolids
land
application
sites.

°
To
date
there
is
no
reliable
evidence
of
a
causal
relationship
between
biosolids
exposure
and
human
health
effects
(
Report
conclusions)

°
Local
health
authorities,
under
existing
public
health
programs,
best
investigate
claims
of
illness
associated
with
biosolids
exposure.
Since
most
of
the
health
effect
s
claims
are
for
common
ailments
(
gastrointestinal
upset,
upper
respiratory
symptoms),
it
is
important
that
any
investigations
of
health
effects
be
conducted
using
rigorous
principles
of
disease
causation.
A
physician
referral
should
be
the
initial
point
of
entry
into
these
programs.

°
The
Centers
for
Disease
Control
and
Prevention
(
CDC)
already
compile
data
on
infectious
diseases
including
many
of
the
gastrointestinal
problems
that
have
been
alleged
to
be
associated
with
biosolids
in
the
past.
It
is
likely
that
CDC
or
state
health
department
data
may
be
able
to
be
used
to
perform
incidence
and
prevalence
studies
without
gathering
additional
information.
Recent
investigations
made
available
to
the
popular
press
do
not
accurately
or
appropriately
generate
useful
statistics
on
adverse
end­
points
such
as
gastroenteritis
(
and
other
infirmities)
because
they
seldom
calculate
relative
risk
comparisons
that
are
essential
to
epidemiological
analyses.

°
POTWs,
biosolids
management
organizations,
and
farmers
already
monitor
the
health
of
workers
exposed
to
biosolids.
These
existing
data
may
be
used
to
evaluate
not
only
health
effects
associated
with
workers,
but
also
alleged
effects
in
the
less­
exposed
general
population.

The
NAS/
NRC
report
called
for
response
incident
investigations,
targeted
exposure
surveillance,
and
well­
designed
epidemiological
studies.
EPA
has
proposed
developing
a
tracking
mechanism
with
CDC
and
collaborative
exposure
assessment
work
with
USDA,
State
of
PA,
and
the
NSF­
WQC
at
the
University
of
Arizona.
It
is
important
to
note
the
following:

°
No
documented
cases
of
human
illness
to
date.
USEPA,
2003d
95
°
Meaningful
epidemiological
studies
probably
can't
be
done
because
of
confounding,
lack
of
exposure
metric,
small
populations,
etc.

°
Physicians
and
local
health
departments
should
be
first
point
of
contact,
screen
out
unjustified
complaints.
Work
with
state
environmental
agencies.

°
CDC
could
keep
national
database
of
justified
complaints,
documented
illnesses.

°
Any
health
studies
should
be
conducted
using
good
practice
and
standard
protocols.

°
Epidemiological
definitions
of
causation
should
be
standard
for
linking
complaint
to
biosolids.

Until
there
is
evidence
that
biosolids
recycling
has
caused
health
problems,
EPA
should
not
consider
any
studies
that
would
waste
valuable
taxpayer's
dollars.
EPA
should
not
waste
taxpayers'
money
on
frivolous
studies
suggested
by
a
small
vocal
minority
of
self­
interested
researchers.
These
are
actions
that
make
Congressional
Oversight
hearings
so
difficult
for
EPA.

Furthermore,
the
burden
of
proof
should
be
on
those
making
allegations
of
deaths
and
serious
illnesses
(
the
so
called
"
sludge
victims").
All
that
is
available
is
anecdotal
information
that
documents
nothing.
The
only
epidemiological
study
done
with
biosolids
was
the
Ohio
Farm
Study
in
1985
that
showed
no
problems
with
families
living
near
sites
where
biosolids
were
land
applied
compared
to
families
living
on
farms
where
no
biosolids
were
used.
If
EPA
wants
t
o
spend
any
money
in
this
area,
it
should
be
to
fully
investigate
some
of
the
claims
of
the
so
called
"
sludge
victims"
with
an
independent
and
credible
third
party,
such
as
the
CDC.

Response
Please
see
Summary
Response
to
this
section
for
EPA
plans
to
track
reported
health
incidents
and
the
development
of
exposure
measurement
tools
to
investigate
reports
of
adverse
human
health
effects
from
exposure
to
sewage
sludge.
EPA
agrees
with
the
comment
that,
to
date,
there
is
no
reliable
evidence
of
a
causal
relationship
between
biosolids
exposure
and
adverse
human
health
effects.

Association
EPA
Log
#
30:
Tri­
TAC
Comment
Additional
Research
Needed
The
first
two
objectives
above
relate
directly
to
the
issue
of
additional
research
 
both
new
studies
designed
to
address
priority
areas
in
the
Part
503
regulations
and
existing
projects
within
and
outside
EPA.
Tri­
TAC
believes
that
EPA's
first
priority
for
conducting
research
to
update
the
scientific
basis
of
Part
503
must
be
a
series
of
exposure
assessment
studies
to
directly
assess
potential
health
impacts
and
to
obtain
additional
data
on
exposure
to
biosolids
and
other
organic
residuals.
USEPA,
2003d
96
Exposure­
Assessment
Studies
to
Compile
Additional
Human
Health
Data
Communities
across
the
U.
S.,
and
especially
in
California,
which
are
considering,
or
have
established,
bans
or
restrictions
on
the
land
application
of
biosolids,
cite
the
lack
of
information
on
the
human
health
effects
of
exposure
to
biosolids.
This
is
where
EPA
can
have
the
most
impact
on
preserving
the
safe
practice
of
land
application
as
a
long­
term,
sustainable
management
alternative
for
biosolids.
The
NRC
Report
makes
a
number
of
recommendations
regarding
this
issue,
foremost
of
which
is
the
need
to
conduct
exposure­
assessment
studies
to
characterize
the
exposures
of
workers
and
the
general
public
who
come
into
contact
with
biosolids
either
directly
or
indirectly.
The
studies
"
would
require
identification
of
microorganisms
and
chemicals
to
be
measured,
selection
of
measurement
methods
for
field
samples,
and
collection
of
adequate
samples
in
appropriate
scenarios"
(
NRC
Report,
p.
6).
These
studies
would
determine
the
makeup
of
emissions
(
e.
g.,
odors,
bio­
aerosols,
volatiles)
from
biosolids
land
application
sites,
measure
the
exposure
potential
for
workers,
such
as
appliers
and
farmers,
as
well
as
nearby
communities,
and
assess
the
potential
nexus
to
human
health
impacts.
Should
the
results
of
these
exposure­
assessment
studies
suggest
a
negative
impact
on
human
health,
additional
resources
could
be
committed
to
conducting
a
complete
epidemiological
study
of
biosolids
use
to
provide
evidence
of
"
a
causal
association,
or
lack
thereof,
between
biosolids
exposure
and
adverse
human
health
effects"
(
NRC
Report,
p.
6).

Tri­
TAC
is
aware
of
a
number
of
research
efforts,
either
currently
underway
or
being
considered
by
organizations
such
as
the
Water
Environment
Research
Foundation
and
the
University
of
Arizona,
which
could
provide
critical
information
for
such
exposure
assessment
studies.
In
addition,
as
with
previous
EPA
efforts,
Tri­
TAC's
public
agency
members
would
be
willing
to
work
with
the
EPA
on
its
ongoing
biosolids
research
efforts.
EPA
should
make
every
attempt
to
use
studies
conducted
by
other
organizations
and
use
the
resources
of
the
biosolids
program
stakeholders,
including
citizens
and
interested
activist
groups,
to
maximize
its
own
limited
resources.

Response
Team
for
Biosolids
Health
Reports
Alleged
or
unsubstantiated
claims
of
adverse
health
effects
are
more
damaging
to
local
biosolids
programs
than
any
other
issue
and
it
is
here
that
public
relations
and
responsive
investigation
must
meet.
Without
the
proper
response
and
investigation
by
a
credible
authority,
citizens
have
no
choice
but
to
believe
the
limited
evidence,
based
more
on
fear
than
fact,
which
is
presented
to
them.
The
logistics
of
an
incident
response
team
capable
of
investigating
past
and
future
claims
of
health
impacts
is
complicated.
There
must
be
a
method
for
timely
notification
and
a
process
for
tracking
and
recording
incidents.
EPA's
involvement
is
key,
as
many
of
the
questions
regarding
biosolids
management
are
national
in
scope,
but
the
process
must
also
acknowledge
that
land­
application
decisions
are
local.
EPA
Headquarters
and
Regional
offices,
states,
and
local
governments
should
all
have
a
role
in
investigating
such
health
claims,
and
the
additional
expertise
of
the
Centers
for
Disease
Control
and
Prevention
(
CDC)
may
also
be
necessary.
Finally,
an
accessible
national
tracking
system
to
document
the
details
of
each
investigation
would
be
vital
to
ensure
biosolids
managers,
local,
state
and
federal
regulators,
and
the
public
have
the
information
they
need
to
make
educated
decisions
concerning
the
land
application
of
biosolids.
USEPA,
2003d
97
Response
Please
see
the
Summary
Response
to
this
section
for
EPA
plans
to
track
reported
health
incidents
and
to
develop
exposure
measurement
tools
to
investigate
reports
of
adverse
human
health
effects
from
exposure
to
sewage
sludge.
EPA
intends
to
build
on
research
being
conducted
by
organizations
outside
of
EPA
and
welcomes
Tri­
TAC's
offer
to
participate
in
this
effort.

EPA
Log
#
50:
Water
Environment
Federation
(
WEF)

Comment
Responsiveness
 
EPA
notes
that
they
are
investigating
cooperative
efforts
with
health
agencies
such
as
the
Centers
for
Disease
Control
(
CDC)
to
respond
to
and
investigate
complaints
of
health
effects
related
to
biosolids
use.
WEF
strongly
encourages
the
development
of
dialogue
between
EPA,
CDC,
and
other
relevant
agencies
on
cooperatively
tracking
incident
reports
and
investigating
whether
adverse
human
health
outcomes
can
be
associated
with
biosolids
exposure.
The
development
of
this
type
of
response
team
is
critical
and
should
be
a
top
priority;
especially
since
human
health
complaints
have
mostly
been
related
to
pathogens
and
odors
(
see
Focus
on
Priorities
above).
Considering
the
complexity
of
the
issue
and
resource
limitations,
EPA
has
made
a
good
effort
to
respond
to
complaints,
however,
WEF
recommends
that
another
agency
like
CDC
play
a
significant
role,
and
even
take
the
lead
in
this
effort
because
of
current
perceptions
regarding
EPA
responsiveness
on
health
complaints.

F.
Human
Health
Studies
The
NRC
recommended
that
EPA
conduct
a
variety
of
investigations
including
epidemiological
studies
of
exposed
populations.
In
its
response,
EPA
indicated
that
the
Agency
does
not
plan
to
conduct
epidemiological
studies
because
they
are
complex,
time
consuming,
and
require
substantial
funding.
It
is
unfortunate,
though
understandable,
that
a
comprehensive
epidemiological
study
along
the
lines
of
the
1985
EPA
study
cannot
be
performed.
Depending
upon
how
they
are
developed,
targeted
human
health
investigations,
which
may
provide
the
basis
for
future
epidemiological
studies,
should
help
address
public
concerns.

In
developing
the
approach
to
any
human
health
studies,
continued
work
with
CDC
is
recommended
and,
if
possible,
it
may
be
preferable
for
the
CDC
to
take
the
lead
in
this
effort.
This
recommendation
stems
from
the
perception
that
EPA
has
not
adequately
addressed
previous
health
complaints,
and
that
the
Agency
is
vested
in
the
beneficial
use
of
biosolids
and
thus
cannot
provide
objective
insight.
Regardless
of
who
leads
such
efforts,
timely,
methodical
and
thorough
responses
to
complaints
regarding
biosolids
will
be
critical
to
gaining
public
confidence.

EPA
also
indicates
that
it
is
investigating
the
possibility
of
developing
a
process
for
timely
notification,
recording,
and
tracking
of
incident
reports
in
collaboration
with
the
CDC.
As
stated
before,
WEF
strongly
supports
EPA's
efforts
to
work
with
CDC
to
identify
mechanisms
for
recording
and
tracking
biosolids
related
incidents.

Response
EPA
agrees
with
these
comments
.

EPA
Log
#
46:
Association
of
Metropolitan
Sewerage
Agencies
(
AMSA)
USEPA,
2003d
98
Comment
Additional
Research
Needed
The
first
two
objectives
above
relate
directly
to
the
issue
of
additional
research
 
both
new
studies
designed
to
address
priority
areas
in
the
Part
503
regulations
and
existing
projects
within
and
outside
the
Agency.
AMSA
believes
that
EPA's
first
priority
for
conducting
research
to
update
the
scientific
basis
of
Part
503
must
be
a
series
of
exposure
assessment
studies
to
directly
assess
potential
health
impacts,
especially
those
associated
with
pathogens,
and
to
amass
additional
data
on
exposure.
AMSA
also
encourages
the
Agency
to
support
research
on
odor
associated
with
biosolids
management
and
ways
to
mitigate
those
odors
during
processing
and
land
application.

Exposure­
Assessment
Studies
to
Compile
Additional
Human
Health
Data
Communities
across
the
U.
S.
that
are
considering,
or
have
established,
bans
or
restrictions
on
the
land
application
of
biosolids
consistently
cite
the
lack
of
information
on
the
human
health
effects
of
exposure
to
biosolids.
This
is
where
EPA
can
have
the
most
impact
on
preserving
land
application
as
a
long­
term,
sustainable
management
alternative
for
biosolids.
The
NRC
Report
makes
a
number
of
recommendations
regarding
this
issue,
foremost
of
which
is
the
need
to
conduct
exposure­
assessment
studies
to
characterize
the
exposures
of
workers
and
the
general
public
who
come
into
contact
with
biosolids
either
directly
or
indirectly.
The
studies
"
would
require
identification
of
microorganisms
and
chemicals
to
be
measured,
selection
of
measurement
methods
for
field
samples,
and
collection
of
adequate
samples
in
appropriate
scenarios"
(
NRC
Report,
p.
6).
These
studies
would
determine
the
makeup
of
emissions
(
e.
g.,
odors,
bio­
aerosols,
volatiles)
from
biosolids
land
application
sites,
measure
the
exposure
potential
for
workers,
such
as
appliers
and
farmers,
as
well
as
nearby
communities,
and
assess
the
potential
nexus
to
human
health
impacts.
Should
the
results
of
these
exposure­
assessment
studies
suggest
a
negative
impact
on
human
health,
additional
resources
could
be
committed
to
conducting
a
complete
epidemiological
study
of
biosolids
use
to
provide
evidence
of
"
a
causal
association,
or
lack
thereof,
between
biosolids
exposure
and
adverse
human
health
effects"
(
NRC
Report,
p.
6).

AMSA
is
aware
of
a
number
of
research
efforts,
either
currently
underway
or
being
considered
by
organizations
such
as
the
Water
Environment
Research
Foundation,
which
could
provide
critical
information
for
such
exposure
assessment
studies.
In
addition,
as
with
previous
EPA
efforts,
AMSA's
public
agency
members
would
be
willing
to
work
with
the
Agency
on
its
ongoing
biosolids
research
efforts.

Response
Team
for
Biosolids
Health
Reports
Alleged
or
unsubstantiated
claims
of
adverse
health
effects
are
more
damaging
to
local
biosolids
programs
than
any
other
issue
and
it
is
here
that
public
relations
and
responsive
investigation
must
meet.
Without
the
proper
response
and
investigation
by
a
credible
authority,
citizens
have
no
choice
but
to
believe
accounts,
based
more
on
fear
than
fact,
that
is
presented
to
them
regarding
potential
health
effects
from
land­
applied
biosolids.
The
logistics
of
an
incident
response
team
capable
of
investigating
past
and
future
claims
of
health
impacts
are
complicated.
There
must
be
a
method
for
timely
notification
and
a
process
for
tracking
and
recording
incidents.
Federal
involvement
is
key,
as
many
of
the
questions
regarding
biosolids
management
are
national
in
scope,
but
the
process
must
also
acknowledge
that
land­
application
decisions
are
local.
EPA
USEPA,
2003d
99
Headquarters
and
Regional
offices,
states,
and
local
governments
should
all
have
a
role
in
investigating
such
health
claims.

AMSA
encourages
EPA
to
develop
a
process
for
timely
notification,
recording,
and
tracking
incident
reports
in
collaboration
with
other
federal
agencies.
Given
their
expertise
in
such
matters,
AMSA
believes
that
the
Centers
for
Disease
Control
and
Prevention
(
CDC)
may
need
to
play
an
integral
role,
if
not
the
lead
role,
in
any
type
of
incident
reporting
process.
Ultimately,
a
national
tracking
system
to
document
the
details
of
each
investigation
would
be
vital
to
ensure
biosolids
managers,
local,
state
and
federal
regulators,
and
the
public
have
the
information
they
need
to
make
educated
decisions
concerning
the
land
application
of
biosolids.

Response
Project
4
Field
Studies
of
Application
of
Treated
Sewage
Sludge
in
today's
FR
notice
responds
to
the
first
paragraph
of
the
comments.
With
respect
to
the
call
for
exposure
studies,
please
see
the
EPA
response
to
comment
Log
No.
30
of
this
section.
EPA
appreciates
AMSA's
offer
to
participate
in
the
Agency's
research
effort.

Counties
EPA
Log
#
28:
Solano
County
Department
of
Environmental
Management
Comment4.
Human
health
surveys
for
potential
health
effects
from
land
applied
biosolids.
A)
Epidemiological
Studies
Solano
County
DEM
strongly
suggests
that
the
USEPA
reevaluate
its
response
to
the
NRC's
Human
Health
recommendations.
While
large
scale
epidemiological
studies
may
be
difficult,
Solano
County
DEM
highly
recommends
that
the
USEPA,
in
coordination
with
the
Center
for
Disease
Control
and
state
and
local
health
agencies,
undertake
at
least
one
study
that
includes
multiple
locations
and
conduct
an
epidemiological
study
that
focuses
on
biosolids
land
application
and
potential
impacts
on
a
community
and
rural
residences
adjacent
to
land
application
sites.

B)
Training,
notification,
and
reporting
In
its
response
to
the
NRC
report,
the
USEPA
states
that
it
is
"
investigating
the
possibility
of
developing
a
process
for
timely
notification,
recording,
and
tracking
incident
reports
in
collaboration
with"
the
CDC.
Solano
County
DEM
believes
that
this
is
extremely
important
and
should
be
given
high
priority
by
the
USEPA.
In
addition,
the
USEPA,
in
coordination
with
CDC,
should
develop
a
program
and
support
training
to
inform
and
educate
State
and
local
health
care
providers
and
regulatory
agencies
of
possible
symptoms
or
effects
from
exposure
to
biosolids,
methods
to
establish
an
integrated
routine
notification
and
reporting
process,
and
processes
for
rapid
response
by
multiple
agencies
and
health
care
providers
so
that
health
complaints
can
be
properly
investigated
for
potential
correlation
to
biosolids
land
application
activities.

Response
With
respect
to
comment
A
and
as
stated
in
the
response
to
Log
No.
8
in
this
section,
EPA
does
not
believe
that
epidemiological
studies
are
the
best
use
of
EPA
resources
to
characterize
potential
health
risks
from
the
land
application
of
sewage
sludge.
EPA
agrees
with
comments
B
and
believe
that
the
activities
described
in
the
Summary
Response
to
this
section
USEPA,
2003d
100
will
lead
to
proper
investigation
of
health
complaints
by
State,
local
health
providers
and
regulatory
agencies.

States
EPA
Log
#
52:
Washington
State
Department
of
Ecology
Comment
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.

In
reviewing
EPA's
response
I
did
not
note
much
of
anything
in
the
way
of
an
actual
plan.
As
an
idea,
however,
I
strongly
support
this
initiative.
There
are
a
number
of
high
profile
cases
around
the
country
which
have
detracted
from
the
national
biosolids
program
and
called
into
question
both
science
and
policies.
The
national
program
is
knit
of
common
fabric,
and
what
ill
befalls
one
state
or
agency,
also
befalls
others.
If
arguments
of
critics
in
these
cases
are
correct,
then
we
need
to
make
changes.
If
they
are
not
correct,
we
need
to
know
why.
Attempts
have
been
made
at
various
times
by
various
persons
and
groups
to
investigate
these
cases
and
provide
summaries.
The
lack
of
ready
resources
and
a
consistent
approach
to
investigation,
response,
and
documentation
is
a
clear
detriment
to
national
program
implementation.
I
feel
compelled
to
once
again
observe
that
the
best
plan
possible
will
be
of
little
value
if
staff
do
not
have
resources
and
ability
to
respond
and
follow
the
established
standard
procedures
for
investigation
and
documentation.
Further,
if
related
short
(
and
long)
term
goals
for
improving
program
knowledge
are
not
realized,
then
investigations
will
be
based
on
data
and
methodologies
that
will
continue
to
be
subject
to
criticism
by
the
people
they
are
most
needed
to
respond
to.

One
additional
suggestion
I
can
offer
here
is
that
EPA
should
set
the
bar
for
what
must
occur
in
order
for
an
incident
to
warrant
a
response.
If
thorough
responses
to
the
most
critical
incidents
are
carried
out
they
will
likely
be
fairly
resource
consumptive.

Response
Please
see
the
Summary
Response
to
this
section:
EPA
has
now
provided
more
details
on
its
actual
plan.
EPA
has
the
proper
resources
to
carry
out
these
activities
which
will
be
complemented
by
research
carried
out
outside
the
Agency.

EPA
Log
#
45:
Florida
Department
of
Environmental
Protection
Comment
Comments
on
the
Program
for
Incident
Management
We
strongly
encourage
the
EPA
to
pursue
cooperation
with
the
CDC
in
developing
and
implementing
an
approach
and
procedures
for
investigating
and
documenting
alleged
illnesses
and
incidents.

The
EPA
is
encouraged
to
stay
informed
of
homeland
security
efforts
by
other
federal
agencies
and
states
in
areas
such
as
chemical
and
biological
agent
detection
and
health
incident
reporting.
It
USEPA,
2003d
101
may
be
that
some
technologies
or
programs
developed
for
homeland
security
could
be
adapted
to
improve
the
biosolids
program.

Response
EPA
agrees
with
these
comments.

EPA
Log
#
48
and
39
(
duplicates):
Wisconsin
Department
of
Natural
Resources
Comment
17.
Section
VIII.
F.
Human
Health
Studies
­
Planned
Human
Health
Activities
­
It
is
stated
that
the
Agency's
primary
objective
is
to
characterize
pollutants
and
microbial
agents
in
biosolids,
but
no
plan
to
fulfill
that
characterization
is
presented
here.
Is
it
intended
that
the
characterization
is
limited
to
that
described
in
parts
A.
Survey
and
B.
Exposure
of
this
section?
There
is
no
provision
to
monitor
microbial
agents
other
than
fecal
coliform
in
Part
A
and
it
is
unclear
what
all
will
be
examined
under
Part
B.
More
specific
detail
of
what
will
be
monitored
should
be
provided
and
whether
and
what
type
of
study
will
actually
be
performed.
It
is
also
noted
that
the
Agency
is
investigating
the
possibility
of
developing
a
notification
and
tracking
system
for
health
complaints.
No
mention
is
made
of
actually
conducting
investigations
into
the
validity
of
adverse
health
allegations
or
who
would
conduct
them.
It
is
critical
that
investigations
be
done
quickly
and
effectively
and
the
results
of
those
investigations
be
tracked
and
available
to
regulators
and
the
public.
EPA
should
comment
further
and
provide
specific
plans
to
address
this
report
recommendation.

III.
The
following
comment
is
in
response
to
EPA's
plan
to
develop
a
process
to
investigate
and
track
incidents
of
alleged
adverse
health
effects.

1.
This
is
a
major
area
of
action
recommended
in
the
NRC
report
and
only
briefly
discussed
under
the
response
plan
as
addressed
above.
It
is
critical
that
state
and
local
health
representatives
work
with
EPA
and
perhaps
CDC
to
investigate
all
alleged
incidents
in
a
timely
and
efficient
manner.
It
is
likewise
imperative
that
the
investigations
be
tracked
and
reported
whether
they
confirm
or
dispel
the
alleged
affect.
This
process
needs
to
be
further
defined
and
articulated
by
the
Agency.

Response
EPA
has
developed
in
today's
FR
notice,
a
more
detailed
description
of
its
work
plan
which
we
believe
responds
to
the
commenters
questions
and
comments:
Project
4
(
Field
Studies
of
Application
of
Treated
Sewage
Sludge)
will
investigate
pollutants
emitted
from
land
application
sites;
Project
5
(
Targeted
National
Survey
of
Pollutants
in
Sewage
Sludge)
will
characterize
the
occurrence
of
certain
chemicals
in
sewage
sludge;
finally,
the
Summary
Response
to
this
section
describes
Project
6
and
7
related
to
the
investigation
of
alleged
incidents
from
exposure
to
sewage
sludge.
EPA
intends
to
work
with
all
stakeholders,
especially
our
State
regulatory
partners
and
CDC
in
accomplishing
the
activities
described
in
the
Summary
Response
to
this
section.

Municipalities
EPA
Log
#
55:
City
of
Rio
Vista,
California
USEPA,
2003d
102
Comment
EPA
'
s
response
also
largely
ignores
NRC
'
s
specific
recommendations
to
do
response
incident
investigation,
targeted
exposure
surveillance
and
well­
designed
epidemiological
investigations
of
exposed
populations.
For
example,
even
with
regard
to
gathering
data
on
incidents,
the
plan
takes
a
wait­
and­
see
attitude:"[
t
]
he
Agency
is
investigating
the
possibility
of
developing
a
process
for
timely
notification,
recording
and
tracking
incident
reports
 ."
Epidemiological
studies
are
deemed
too
costly
to
perform
and
will
not
be
done.

Response
Please
see
the
Summary
Response
to
this
section.
As
stated
before,
EPA
does
not
believe
that
epidemiological
studies
are
the
best
use
of
EPA
resources
to
characterize
potential
health
risks
from
the
land
application
of
sewage
sludge.

TOPIC
G.
REGULATORY
ACTIVITIES
Summary
Response
As
discussed
below
and
in
today's
Federal
Register
notice,
EPA
will
be
evaluating
whether
to
propose
a
new
pollutant
concentration
limit
and
cumulative
pollutant
loading
rate
for
molybdenum
in
land­
applied
sewage
sludge.
In
addition,
possible
regulatory
changes
may
be
forthcoming
pending
the
results
of
the
studies
and
refined
risk
assessment
outlined
in
the
FR
Notice.
At
this
time,
EPA
is
committing
to
take
only
one
short­
term
action
on
Part
503
revisions.
Project
13
in
Section
VII
B
in
today's
Federal
Register
Notice
commits
to
a
review
of
molybdenum
numerical
standards
for
land­
applied
sewage
sludge
under
the
Part
503
Rule.
A
full
set
of
numerical
standards
for
molybdenum
in
land
applied
sewage
sludge
was
included
in
the
Round
One
Part
503
Rule
when
it
was
published
in
February,
1993.
Based
on
a
judicial
challenge
to
this
part
of
the
Part
503
Standards,
EPA
withdrew
all
molybdenum
numerical
standards
with
the
exception
of
the
"
maximum"
numerical
standard
from
the
Part
503
Rule.
EPA,
in
the1994
Federal
Register
notice
that
announced
the
withdrawal,
indicated
that
at
a
future
date,
EPA
would
reevaluate
the
information
that
it
had
on
molybdenum
and
re­
propose
the
three
numerical
standards
that
had
been
withdrawn.
The
project
described
below
fulfills
that
commitment.

Project
13:
Review
Criteria
for
Molybdenum
in
Land­
applied
Treated
Sewage
Sludge
One
of
the
NRC's
recommendations
was
that
EPA
should
propose
molybdenum
standards
to
replace
those
that
EPA
rescinded
following
a
legal
challenge
to
numerical
limitations
promulgated
in
the
Round
One
rule.
Also,
some
commenters
believe
that
EPA
should
reassess
the
molybdenum
standard.
The
preliminary
strategy
in
the
April
9,
2003
notice
indicated
that
EPA
would
determine
the
applicability
of
new
information
as
the
basis
for
re­
proposing
molybdenum
standards
for
land­
applied
sewage
sludge.
See
68
FR
17391.
This
activity
is
included
in
the
Agency's
final
action
plan,
as
stated
below.

In
2000,
EPA
held
a
workshop
to
update
toxicity
and
environmental
properties
for
molybdenum
in
sewage
sludge.
Based
on
that
workshop,
EPA
intends
to
assess
the
need
and
appropriate
level
for
a
numerical
standard
for
molybdenum
in
sewage
sludge
using
a
summary
of
USEPA,
2003d
103
workshop
results
and
conclusions,
supplemented
with
additional
data
developed
since
2000.
EPA
expects
to
complete
this
assessment
in
2005.

In
the
long
term,
EPA
commits
to
evaluate
all
of
the
information
that
is
generated
from
today's
Federal
Register
Notice's
action
plan
of
research.
Based
on
this
information,
EPA
commits
to
revisit
all
of
the
Part
503
Standards
and
propose
amendments
to
these
Standards
if,
based
on
this
information,
EPA
determines
that
Part
503
amendments
are
necessary
to
enhance
public
health
and
environmental
protection
from
chemical
pollutants
and
pathogens
in
landapplied
sewage
sludge.
Based
on
the
schedule
for
potentially
proposing
numerical
standards
for
pollutants
identified
in
the
screening
exercise
under
the
Section
405(
d)(
2)(
C)
Clean
Water
Act
requirement
described
in
Section
IX
of
today's
Federal
Register
Notice,
EPA
will
first
design
and
conduct
a
targeted
national
survey
of
pollutants
in
sewage
sludge
in
2005
through
2007.
The
results
of
the
survey
will
provide
pollutant
concentration
values
that
EPA
will
then
use
in
a
more
refined
risk
assessment
and
risk
characterization.
Based
on
the
results
of
these
refined
analyses,
EPA
will
propose
as
soon
as
practicable
new
regulations
under
Section
405(
d)
for
any
pollutants
which
it
determines
may
be
present
in
sewage
sludge
in
concentrations
which
may
adversely
affect
public
health
or
the
environment.

Academia
EPA
Log
#
51:
Ellen
Z.
Harrison
Comment
In
response
to
a
request
from
a
municipality,
I
developed
a
draft
municipal
ordinance
that
addresses
many
of
the
concerns
posed
by
the
land
application
of
sewage
sludges
(
Harrison,
2003).
I
believe
that
EPA
should
enact
these
provisions
nationally
as
a
means
to
be
reasonably
protective
of
public
health
and
the
environment.

Response
EPA
has
reviewed
this
information
and
thanks
the
commenter
for
submitting
it.
See
the
Summary
Response
to
this
section
of
the
document.
It
is
possible
that
some
of
provisions
in
this
draft
ordinance
could
eventually
be
incorporated
into
the
Part
503
Standards
based
on
the
process
described
in
the
Summary
Response.

Citizens
EPA
Log
#
8:
David
A.
Burrows
Comment
The
regulation
of
molybdenum
in
biosolids
needs
to
be
reassessed
as
recommend
by
the
NRC.
(
Federal
Register
p.
17382)

The
NRC
recommendation
that
"
the
elimination
of
exemptions
for
nutrient
management
and
site
restrictions
for
land
applied
EQ
biosolids"
(
Federal
Register
p.
17390)
is
necessary
to
protect
both
the
environment
and
human
health.
USEPA,
2003d
104
You
state
(
Federal
Register
p.
17391):
"
States
and
local
jurisdictions
will
have
better
knowledge
of
local
conditions,
and
are
in
better
position
to
establish
additional
management
practices
to
augment
the
protectiveness
of
the
part
503
standards."
Many
states,
Pennsylvania
included,
do
not
allow
local
governments
(
counties,
townships)
to
adopt
strict
regulations
with
regards
to
biosdids.
In
fact,
local
jurisdictions
are
virtually
powerless.
This
emphasizes
the
need
for
the
EPA
to
adopt
strict
regulations
that
are
truly
protective
of
both
human
health
and
the
environment.
EPA's
mandate
is
to
protect
the
citizens
of
this
country,
not
the
sludge
industry.

On­
page17391
of
the
Federal
Register
it
states
that
"
part
503
numerical
standards
are
based
on
a
conservative
set
of
exposure
pathway
and
risk
assessment
assumptions."
Research
is
needed
to
support
these
assumptions.

Also
on
page
17391
of
the
Federal
Register
it
states
that
"
EPA
is
planning
to
evaluate
certain
Class
B
disinfection
processes
including
the
natural
attenuation
of
pathogens
that
occurs
while
sludge
is
on
or
in
the
soil."
There
is
an
absolute
need
for
accurate
data
regarding
Class
B
"
disinfection"
to
protect
human
and
environmental
health.
There
is
also
the
need
for
strict
monitoring
system
so
that
"
disinfection"
is
done
correctly
every
time.
With
regard
to
the
natural
attenuation
of
pathogens
while
sludge
is
in
or
on
the
soil,
the
period
of
study
should
be
at
least
one
year
to
check
for
the
regeneration
of
pathogens.

Response
See
the
Summary
Response
in
this
section
of
the
document.
EPA
does
recognize
the
importance
of
site­
specific
conditions
in
establishing
protective
sewage
sludge
standards.
The
Part
503
Standards
are
designed
to
be
conservative.
As
such,
EPA
believes
that
they
are
generally
protective
throughout
the
United
States.
However,
the
Part
503
Standards
have
a
provision
that
allows
EPA
Permitting
Authorities
to
add
requirements
to
the
base
Part
503
Standards
and/
or
modify
the
Part
503
Standards
to
effect
a
more
protective
set
of
standards
based
on
local
conditions
to
enhance
protection
of
public
health
and
the
environment.
States
through
their
own
sewage
sludge
standards
can
(
and
almost
all
do)
have
additional
and/
or
more
stringent
sewage
sludge
standards
that
recognize
local
site­
specific
conditions.

EPA
Log
#
29:
Henry
J.
Staudinger
Comment
G.
EPA's
Regulatory
Activities
Strategy
is
Not
Adequate.
NRC
Recommends
national
standard
criteria,
the
development
of
regulatory
criteria
for
biosolids
in
a
timely
fashion
and
the
identification
of
additional
regulatory
mechanisms
to
better
protect
public
health
and
the
environment,
development
of
a
quantitative
microbial
risk
assessment
to
establish
regulatory
criteria
for
pathogens,
studies
to
determine
if
Part
503
achieves
its
intended
effect
and
the
elimination
of
exemptions
for
nutrient
management
site
restrictions.

EPA
objects
to
national
standard
criteria
on
the
basis
of
its
unsupported
assertion
that
Part
503'
s
numerical
criteria
for
pollutants
in
biosolids
together
with
operational
standards
for
pathogen
and
vector
attraction
reduction
are
appropriate
to
protect
public
health
when
complied
with.
It
also
cites
the
difficulties
in
applying
national
standard
criteria
to
local
pollution
sensitive
circumstances
cited
by
NRC.
USEPA,
2003d
105
Instead
of
rejecting
a
national
criterion
because
of
local
pollution
sensitive
circumstances,
EPA
should
recognize
the
need
to
develop
national
standards,
to
be
supplemented
to
reflect
local
conditions.
Although
EPA
says
that
it
plans
to
evaluate
such
practices
to
determine
if
additional
requirement
are
warranted,
based
on
past
experience
there
is
little
expectation
that
EPA
will
do
so.

EPA's
refusal
to
address
local
pollution
sensitive
conditions
in
the
past
as
well
as
its
failure
to
admit
that
it
has
long
been
aware
of
the
need
to
modify
the
regulations
in
to
bring
those
situations
within
the
parameters
of
the
risk
assessment
it
relies
on,
provide
little
comfort
that
EPA
will
implement
this
part
of
its
strategy.

There
must
be
a
clear
regulatory
directive
that
local
public
health
and
environmental
issues
be
addressed
before
biosolids
can
be
land
applied.
To
this
end,
input
from
localities
regarding
local
pollution
sensitive
conditions
is
essential.

Response
Please
see
the
EPA
response
to
Comment
Log
No.
8
of
this
section
of
this
document.

EPA
Log
#
49:
The
Resource
Institute
for
Low
Entropy
Systems
Comment
Congress
should
amend
the
Clean
Water
Act
to
eliminate
language
about
the
"
beneficial
use"
of
sewage
sludge.
There
is
no
beneficial
use
for
this
toxic
waste
product.
Research
and
action
should
be
focused
on
how
to
produce
less
of
it
and
how
to
safely
dispose
of
it
so
that
it
causes
no
public
health
or
environmental
harm.

Response
EPA
disagrees
with
this
comment.
As
long
as
land
application
projects
comply
with
Part
503
and
complimentary
State
Standards,
EPA
believes
that
land
application
is
an
appropriate
choice
for
the
management
of
sewage
sludge.
Sewage
sludge
when
applied
under
these
conditions
is
considered
a
beneficial
practice
since
the
sewage
sludge
acts
as
a
crop
nutrient
source
and
as
a
soil
amendment.

EPA
Log
#
36:
Lynton
S.
Land
Comment
EPA
has
established
a
list
of
toxic
chemicals
as
part
of
the
Toxic
Release
Inventory.
Irrespective
of
the
rate
at
which
that
list
is
updated,
the
number
of
chemicals
of
environmental
concern
almost
certainly
grows
larger
each
year
and
the
amounts
released
to
POTWs
increase
most
years.
It
is
certain
that
the
numbers
reported
annually
in
the
TRI
are
low,
not
only
because
new
chemicals
are
generated
each
year
making
the
list
continually
out­
of­
date,
but
because
there
are
many
loopholes
in
the
reporting
process,
leniency
in
who
must
report,
and
opportunities
for
failing
to
comply
with
applicable
laws
because
of
lack
of
rigorous
oversight.
What
matters
is
not
what
substances
are
released
to
POTWs,
but
what
substances
are
released
into
contact
with
the
public.

In
the
case
of
soluble
substances,
EPA
relies
on
dilution
to
reduce
the
concentration
of
the
toxic
substances
to
a
low
enough
level
that
it
is
impossible
to
"
prove"
that
the
public
is
being
harmed.
USEPA,
2003d
106
EPA's
philosophy
is
based
on
economics,
where
human
heath
issues
are
balanced
against
the
purported
economic
needs
of
industry.

In
the
case
of
insoluble
substances,
I
can
find
no
evidence
that
EPA
seriously
considers
the
concentration
of
the
toxic
substances
released
to
the
environment
in
the
effluent
from
POTWs,
namely
in
the
sludge.
This
is
despite
a
1979
study
(
EPA­
4401­
79
­
300
"
Fate
of
Priority
Pollutants
in
Publicly
Owned
Treatment
Works:
Pilot
Study")
that
clearly
demonstrated
that
some
toxic
substances
are
concentrated
in
the
sludge,
and
some
POTWs
are
worse
than
others.
Attached
is
correspondence
with
Mr.
Hanlon
in
this
regard.
It
is
obvious
from
his
reply
that
EPA
has
no
intention
of
trying
to
identify
those
POTWs
that
are
the
worst
offenders,
and
has
no
mechanism
to
routinely
determine
the
concentration
of
toxic
substances
in
sludge.

EPA
is
responsible
for
protecting
the
environment.
Once
a
substance
is
declared
toxic,
it
is
EPA's
responsibility
to
determine
the
extent
to
which
the
substance
is
released
to
the
environment
in
the
air,
water
or
sludge.
Once
the
release
rate
is
known,
then
and
only
then
can
decisions
be
made
(
not
necessarily
by
EPA)
as
to
whether
the
current
practice
is
"
safe,"
or
whether
remedial
action
is
necessary.
Obviously
the
best
practice,
which
has
been
reasonably
successful
in
the
case
of
heavy
metals
in
sludge,
is
to
turn
off
the
tap.
EPA's
current
policy
serves
the
interest
of
those
who
release
the
toxic
chemicals
into
public
facilities,
not
the
interest
of
the
public
who
are
then
in
a
position
to
be
affected
by
the
chemicals.

I
therefore
formally
request
that
EPA
address
the
role
of
sewage
sludge
in
releasing
toxic
chemicals
(
as
defined
by
EPA)
to
the
environment.
At
an
absolute
minimum
EPA
should
tabulate
the
kinds
and
amounts
of
substances
on
the
TRT
list
received
by
each
POTW
that
receives
toxic
chemicals.
EPA
should
further
require
that
all
sewage
sludge
destined
for
land
application,
from
POTWs
that
receive
toxic
influent,
be
analyzed
for
all
substances
the
POTW
receives.
The
results
should
all
be
readily
available
to
all
potential
recipients
of
the
sludge
and
routinely
provided
to
the
state
agencies
responsible
for
land
application
practices.
The
public
deserves
to
know
which
POTWs
receive
toxic
substances
in
their
influent
stream,
the
amounts
of
the
substances
involved,
and
the
concentration
of
the
substances
in
the
sludge.

Response
EPA
has
developed
the
Part
503
Standards
based
on
two
National
Sewage
Sludge
surveys
designed
to
identify
relevant
pollutants
in
the
Nation's
sewage
sludge.
EPA
will
be
designing
and
executing
a
third
pollutant
analytical
survey
starting
in
FY
2005.
EPA
believes
that
the
information
produced
in
these
three
surveys
is
the
appropriate
information
to
base
Part
503
rulemaking
on.
See
the
comments
and
responses
on
the
survey
at
the
beginning
of
this
document.

EPA
Log
#
40:
Thomas
F.
Albert
Comment
Comment
#
35:
On
page
17391
EPA
devotes
a
few
paragraphs
as
to
how
EPA
plans
to
address
NRC
regulatory
recommendations.
This
section,
like
most
others
in
the
EPA
comments,
is
disappointing.
EPA
states
"
Part
503
is
designed
to
protect
public
health
through
compliance
not
onlywith
numerical
criteria
for
pollutants
found
in
biosolids,
but
also
with
operational
standards
for
pathogen
and
vector
attraction
reduction."
Why
doesn't
EPA
admit
USEPA,
2003d
107
here
that,
if
the
Part
503
is
working
so
well
why
is
the
NRC
report
345
pages
in
length
and
contain
57
recommendations?
Obviously
there
is
much
need
for
improvement,
why
doesn't
EPA
admit
it?
EPA,
in
the
"
Standardized
Management
Practices"
section,
states
"
These
operational
standards
are
performance
based,
based
on
operational
goals
for
specified
reduction,
to
enable
elimination
of
pathogens
 
"
This
is
MISLEADING
since
most
sludge
is
no
better
than
Class
B
and
Class
B
is
not
known
to
have
all
of
its
pathogens
eliminated.
In
the
same
section
EPA
notes,
"
EPA
believes
that
such
means
are
appropriate
for
achieving
environmental
performance
while
encouraging
efficient,
cost­
effective,
and
innovative
systems
and
approaches."
If
these
methods
are
so
good;
1)
why
does
the
NRC
report
contain
so
many
findings
and
recommendations
regarding
the
need
to
determine
whether
or
not
the
chemical
and
pathogen
standards
are
protective,
and
2)
why
do
so
many
thousands
of
people
living
near
sludge
fields
complain
about
odor,
illness,
water
contamination,
etc.?
In
the
same
section
(
Standardized
Management
Practices)
EPA
says
"
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."
This
is
SELF
SERVING
AND
MISLEADING.
EPA
is
trying
to
excuse
its
way
out
of
making
better
regulations.
EPA
also
knows
full
well
that
controlling
sludge
at
the
local
level
is
not
very
successful
as
local
jurisdictions
usually
have
little
or
no
authority
to
regulate
such
material.
EPA
also
notes
regarding
pollutants
(
presumably
just
chemicals)
in
sludge
that
"
the
Part
503
Standards
consist
of
numerical
limits
with
adequate
margins
of
safety
to
protect
public
health
and
the
environment."
If
this
is
true,
why
does
the
NRC
report
as
its
first
overarching
recommendation
include
the
wording
"(
1)
new
risk
assessments
should
be
conducted
to
update
the
scientific
basis
of
the
chemical
limits"
'(
page
4
of
NRC
report)?
If
the
chemical
standards
are
so
protective,
why
does
the
NRC
report
(
page
12)
present
a
chemical
standards
Finding
as
"
The
committee
found
the
technical
basis
of
the
1993
chemical
standards
for
biosolids
to
be
outdated"?

Comment
#
36:
In
the
very
brief
"
Studies"
section
(
10
lines)
of
the
discussion
as
to
how
EPA
plans
to
address
NRC
regulatory
recommendations
(
page
17391)
EPA
notes
a
proposed
study
regarding
Class
B
sludge.
EPA
states
that
it
"
is
planning
to
evaluate
certain
Class
5
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
current
regulations."
This
is
one
of
the
very
few
mentions
of
Class
B
sludge
in
the
EPA
comments.
In
view
of
the
tremendous
number
of
complaints
generated
regarding
Class
B
sludge,
it
is
good
to
see
that
EPA
is
actually
going
to
do
a
study.
It
is
interesting
to
note
that
in
mentioning
this
study,
EPA
does
not
use
"
delay
words"
such
as
possibly
or
preliminary,
or
consider
or
may.

Response
Please
see
the
Summary
Response
to
this
section
of
this
document.

EPA
Log
#
25:
Northumberland
Association
for
Progressive
Stewardship
(
NAPS)
Sewage
Sludge
Study
Group
Comment
G.
Regulatory
Activities
Lines
1040­
1068.
The
State
of
Virginia
is
awaiting
changes
in
federal
regulations
in
order
to
update
its
ordinances
and
regulations,
as
provided
for
in
recently
passed
state
law.
It
appears
that
EPA,
in
this
section,
is
planning
to
avoid
the
establishment
of
national
standard
treatment
design
USEPA,
2003d
108
criteria.
Leaving
this
important
element
to
the
discretion
of
the
states
will
not,
in
our
judgment,
resolve
the
issue.
This
is
especially
true
in
Virginia,
where
we
import
many
tons
of
sludge
from
out
of
state,
yet
have
no
quality
control
over
sludge
being
sent
across
our
border
and
land
applied.
We
do
not
know,
for
example,
the
concentration
of
any
of
the
toxic
chemicals
in
EPA's
Toxic
Release
Inventory
in
sewage
sludge
imported
in
our
state,
nor
the
concentrations
of
these
chemicals
released
to
specific
POTWs
that
supply
the
sludge.

Lines
1043­
1059.
As
for
regulations
from
other
nations,
we
are
of
the
opinion
that
they
definitely
should
be
reviewed
by
EPA,
as
we
are
told
that
they
are
ahead
of
this
Country
in
this
field
of
expertise
and
regulation
and
may
be
very
useful.
In
Europe,
for
example,
contrary
to
the
"
honey
buckets"
I
experienced
in
Germany
during
the
early
sixties,
aggressive
action
is
being
taken
in
several
countries
in
the
interest
of
public
health,
by
banning
land
application.
(
See
http://
www.
members.
aol.
com/
wwanglia/
framesf.
htm
on
NATS
website
www.
LouounNATS.
org.

Response
Please
see
the
Summary
Response
to
this
section
and
response
to
EPA
log
#
8
of
the
document
that
refers
to
local
conditions.
As
stated
in
the
proposed
action
plan
in
the
April
9,
2003
Federal
Register
Notice,
EPA
believes
that
"
National
Design
Criteria"
are
not
the
most
effective
method
for
environmental
and
public
health
protection.
Please
refer
to
this
April
9,
2003
for
a
detailed
discussion
on
EPA's
position
on
this
issue.
EPA
as
stated
in
the
April
9,
2003
Notice
is
aware
of
other
countries
sewage
sludge
standards.
For
the
reasons
outlined
in
the
April
9,
2003
Notice,
EPA
believes
that
the
Part
503
Standards
are
as
equally
protective
of
public
health
and
the
environment
and
are
based
on
conservative
risk
assessment
and
technology
concepts.
Other
country's
standards
are
based
on
other
philosophies
(
such
as
the
so
called
"
Precautionary
Principle")
that
do
not
reflect
Clean
Water
Act
mandates.

Environmental
Groups
EPA
Log
#
43:
Natural
Resources
Defense
Council
(
NRDC)

Comment
EPA'S
PROPOSED
DECISION
NOT
TO
REGULATE
ADDITIONAL
TOXIC
POLLUTANTS
EPA
is
required
to
review
the
part
503
sewage
sludge
regulations
at
least
every
two
years
for
the
purpose
of
identifying
additional
toxic
pollutants
and
promulgating
regulations
for
such
pollutants.
According
to
EPA's
preliminary
review
of
existing
sewage
sludge
regulations,
"
EPA
has
not
identified
any
additional
toxic
pollutants
that
warrant
regulation
in
sewage
sludge."
Instead,
EPA
plans
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.
"

NRDC
calls
on
EPA
to
regulate
additional
toxic
pollutants.
In
particular,
NRDC
urges
EPA
to
sample
sewage
sludge
for
toxic
pollutants
and
to
regulate
all
of
those
that
are
found
to
be
present
in
sewage
sludge
in
concentrations
which
may
adversely
affect
public
health
or
the
environment.
According
to
the
attached
comment
by
Dr.
David
0.
Carpenter,
"
at
the
very
least
all
persistent
and
highly
toxic
substances
should
be
regulated."
Furthermore,
the
criteria
upon
which
EPA
has
based
USEPA,
2003d
109
its
preliminary
review
is
"
no
longer
valid"
according
to
the
attached
comment
by
Dr.
Peter
L.
deFur.
Dr.
deFur
recommends
that
EPA
consider
regulation
of
a
number
of
classes
of
pesticides,
metals,
organic
compounds,
pharmaceuticals,
and
industrial
compounds.
Based
on
these
attached
comments
and
the
literature
they
reference,
NRDC
urges
EPA
to
reconsider
its
preliminary
review
of
the
sewage
sludge
regulations
and
to
move
forward
regulation
for
all
those
additional
toxic
pollutants
in
sewage
sludge
that
may
be
present
in
sewage
sludge
in
concentrations
which
may
adversely
affect
public
health
or
the
environment.

EPA
does
not
commit
to
implement
any
of
these
recommendations.
It
does
indicate
that
it
plans
to
make
a
determination
in
the
next
year
whether
to
re­
regulate
molybdenum
and
whether
to
ban
sale
of
non­
EQ
sludge,
but
it
does
not
actually
commit
to
setting
any
new
standards,
to
improving
any
management
practices,
to
setting
any
new
national
treatment
design
criteria,
or
changing
any
other
aspect
of
current
sludge
regulation
or
practice.
Indeed,
under
the
heading
"
Planned
Regulatory
Activities,"
EPA's
Response
identifies
only
"
Studies
"
that
it
plans
to
pursue.

Response
Today's
Federal
Register
Notice
announces
the
results
of
the
screening
analysis
performed
under
Section
405(
d)(
2)(
C)
of
the
Clean
Water
Act.
Thus,
EPA
has
fulfilled
its
statutory
mandate.

Comments
of
Dr.
David
O.
Carpenter
The
current
EPA
regulations
of
biosolids
(
sewage
sludge)
f
ail
to
protect
the
public
health,
and
are
much
less
stringent
than
comparable
regulations
in
other
developed
countries.
The
EPA
has
no
regulation
of
chromium
or
of
any
organic
pollutant,
including
persistent
and
highly
toxic
substances
such
as
dioxins/
furans,
PCBs,
pesticides
and
other
persistent
organics.
Furthermore,
there
is
no
regulation
of
any
contaminant
that
is
present
in
less
than
5%
of
the
biosolids
analyzed
in
the
National
Sewage
Sludge
Survey,
which
means
that
a
local
industry
that
produces
a
toxic
substance
riot
commonly
found
in
biosolids
may
contaminate
locally
produced
biosolids
with
impunity.
At
the
very
least
all
persistent
and
highly
toxic
substances
should
be
regulated.
The
practice
of
exempting
from
regulation
all
substances
that
are
not
present
in
at
least
5%
of
biosolids
should
be
abandoned
in
favor
of
standards
more
protective
of
the
public
health.

Do
EPA's
regulations
adequately
protect
public
health
from
contaminants
in
biosolids?
Biosolids
contain
a
number
of
toxic
and
substances
potentially
dangerous
to
human
health.
These
include
metals,
organic
pollutants,
pharmaceuticals,
and
microbial
and
parasitic
organisms.
The
present
paper
will
not
further
consider
pharmaceutical,
microbial
or
parasitic
contamination,
although
these
are
obviously
of
importance.

There
are
a
number
of
considerations
when
attempting
to
determine
to
what
degree
the
chemical
contaminants
constitute
a
danger
to
human
health.
These
include
concentration,
persistence,
likelihood
of
human
contact
by
ingestion,
inhalation
or
dermal
absorption
and
degree
of
toxicity.
While
recycling
of
the
nutrients
and
organic
matter
contained
in
biosolids
is
an
excellent
strategy
in
theory,
the
benefits
of
such
re­
use
must
be
balanced
by
concern
that
the
practice
of
recycling
may
harm
the
health
of
people,
wildlife
and
the
ecosystem
because
of
the
fact
that
many
toxic
substances
are
concentrated
in
the
sludge.
Moreover,
application
of
biosolids
to
some
sites
may
USEPA,
2003d
110
pose
significantly
greater
danger
of
human
exposure,
either
directly
or
indirectly
through
animal
or
food
contamination
which
is
then
consumed
by
people,
whereas
application
to
other
sites
may
pose
significantly
less
danger
of
human
exposure.
Current
regulations
do
not
distinguish
residential
lawn
or
garden
application
from
application
to
corn
or
soy
bean
fields
or
pastures.

Of
the
various
considerations
listed
above,
persistence
of
the
contaminant
is
an
important
factor.
Metals,
being
natural
elements,
are
never
going
to
go
away,
and
therefore
it
is
appropriate
that
application
of
metals
to
topsoil
of
any
type
be
regulated
carefully.
Our
knowledge
of
the
long­
term
dangers
of
metals
is
best
typified
by
the
legacy
of
lead
paint
and
leaded
gasoline,
which
have
contaminated
soils
around
the
outsides
of
old
houses
painted
with
leaded
white
paint
as
well
as
the
soils
around
major
highways
and
streets
that
carried
traffic
burning
leaded
gasoline
for
many
years
(
Mielke,
1999).
It
must
be
expected
that
this
contamination
will
continue
to
pose
a
health
hazard
for
the
foreseeable
future.
The
toxicity
of
other
metals
is
also
well
documented
(
Lawrence
and
McCabe,
1995;
Carpenter,
2001),
and
as
for
lead
the
health
hazards
include
both
cancer
and
non­
cancer
effects
(
Ostrowski
et
al.,
1999).
Thus,
it
is
appropriate
for
EPA
to
establish
limits
on
levels
of
metals
in
biosolids.
While
there
may
be
some
debate
as
to
the
specific
levels
established
for
the
nine
metals
currently
regulated
(
McBride,
1998),
this
issue
is
beyond
the
scope
of
this
report.

Of
those
substances
not
currently
regulated
by
40
CFR
Part
503,
the
greatest
concern,
in
the
judgment
of
the
author,
is
for
those
organic
substances
that
persist
in
the
environment
and
in
the
bodies
of
animals
and
humans.
This
includes
particularly
dioxins/
furans,
PCBs
and
chlorinated
pesticides,
and
newly
recognized
substances
such
as
polybrominated
diphenyl
ethers
and
perfluorooctyl
sulfonates.
These
substances
are
known
carcinogens,
immune
system
suppressors,
endocrine
disruptors
and
neurobehavioral
toxicants.
The
fact
that
they
persist
in
the
environment
makes
them
particularly
dangerous.

While
a
number
of
other
organic
substances
have
significant
toxicity
(
polyaromatic
hydrocarbons,
phthalates,
pesticides
other
than
organochlorines,
detergents
and
other
volatile
organics
and
solvents),
most
of
these
substances
are
somewhat
less
persistent.
However,
all
have
significant
toxicity.
For
example,
polyaromatic
hydrocarbons
are
known
carcinogens
(
Mastrangelo
et
al.,
1996).
Gray
et
al.
(
1999)
have
demonstrated
that
antiaindrogenic
pesticides
and
phthalates
alter
male
rat
reproductive
function,
while
Colon
et
d.(
2000)
have
reported
that
phthalate
esters
in
the
serum
of
young
girls
is
associated
with
premature
breast
development.
Christiansen
el:
al.(
1998)
have
found
nonylphenol
to
be
estrogenic
in
male
fish,
altering
testicular
function.
Thus,
even
though
these
compounds
are
less
persistent,
they
are
toxic
to
humans.

In
at
least
two
regards,
the
EPA
decisions
on
how
to
regulate
contaminants
in
biosolids
do
not
protect
the
health
of
the
public.
There
are
a
multitude
of
other
industrial
products
which
will
be
present
in
biosolids
resulting
from
local
industry.
Some
of
these
may
be
persistent,
highly
toxic
and
at
high
concentrations
in
locally­
produced
biosolids.
If,
however,
these
particular
contaminants
were
not
found
to
be
present
in
10%
of
all
biosolids
sampled,
they
were
declared
exempt
from
regulation.
This
is
not
justifiable.
Since
the
identify
of
releases
from
various
industries
is
pretty
well
known
on
the
basis
of
approvals
granted
through
the
Toxic
Release
USEPA,
2003d
111
Inventory
or
waste
water
discharge
permits,
there
should
be
no
great
difficulty
in
identifying
substances
that
should
be
biosolids
collected
from
the
vicinity
of
such
industries.
NAS
(
2002)
clearly
states
that
the
EPA's
decision
not
to
regulate
any
chemical
that
was
detected
in
less
than
5%
of
samples
in
the
Nation
Sewage
Sludge
Survey
is
not
justified,
and
I
strongly
concur
with
this
conclusion.

The
second
decision
which
fails
to
protect
the
human
health
of
the
public
is
the
exclusion
from
regulation
of
all
substances
no
longer
manufactured
in
the
United
States.
This
results
in
exemption
of
PCBs
and
chlorinated
pesticides,
substances
known
to
be
present
in
some
biosolids
at
high
concentrations
and
substances
with
well­
documented
human
toxicity.
The
NAS
(
2002)
states
the
EPA
should
not
exclude
chemicals
from
regulatory
consideration
based
solely
on
whether
or
not
those
chemicals
have
been
banned
from
manufacture
in
the
United
States
(
e.
g.,
PCBs)
since
they
are
still
found
in
sewage
sludge
from
many
wastewater
treatment
plants,
and
I
completely
agree
with
this
conclusion.

Regulations
for
Contaminants
in
Biosolids
in
Europe:
While
the
regulations
for
contaminants
in
biosolids
varies
among
the
various
countries
in
Europe,
in
general
the
concentration
limits
are
much
lower
than
in
the
US,
and
more
substances
are
regulated
(
NAS,
2002).
Chromium
is
regulated
in
most
European
countries.
Dioxins/
furans,
PCBs,
the
sum
of
organohalogenated
compounds,
nonylphenyls,
di(
2­
ethylhexyl)
phthalate,
linear
alkyl­
benzene
sulfonates,
and
polyaromatic
hydrocarbons
are
all
regulated
in
at
least
some
European
countries.

Substances
Which
Should
Be
Regulated
under
Part
503:
Chromium:
While
EPA
originally
included
chromium
in
the
list
of
regulated
metals,
this
was
dropped
at
a
later
date.
Chromium,
especially
in
the
hexavalent
form,
is
a
known
human
carcinogen,
causes
liver
and
kidney
damage
and
gastrointestinal
irritation,
and
even
the
less
toxic
Cr(
lll)
is
a
mutagen
(
Pellerin
and
Booker,
2000).
As
indicated
above
chromium
in
biosolids
is
regulated
in
almost
every
European
country.
While
chromium
may
not
be
present
in
most
biosolids,
it
is
known
to
be
at
high
levels
in
the
vicinities
of
certain
industries.
Because
it
is
a
very
dangerous
metal
there
is
no
question
that
it
should
be
regulated
in
biosolids.

Dioxins/
furans
and
coplanar
PCBs:
Dioxins
are
classified
as
known
human
carcinogens.
Dioxins
and
furans
are
a
mixture
of
75
individual
congeners,
depending
upon
the
number
and
positions
of
chlorines
around
the
rings.
Those
which
certain
position,
especially
in
the
2,3,7,8
positions,
are
potent
in
binding
to
the
aryl
hydrocarbon
(
Ah)
receptor.
The
Ah
receptor,
for
which
the
endogenous
ligand
is
not
known,
is
one
of
the
classes
of
cytosolic
receptors
which
when
activated
triggers
gene
induction
and
alterations
in
protein
synthesis
(
Okey
et
al.,
1994).
Certain
of
the
209
PCB
congeners,
those
that
assume
a
coplanar
position
on
the
basis
of
not
having
chlorines
in
the
ortho­
position,
also
activate
the
Ah
receptor,
albeit
not
with
as
high
an
affinity
as
the
most
toxic
dioxin
congener.
However,
because
the
concentrations
of
PCBs
in
the
environment
are
usually
much
higher
than
those
of
dioxin,
the
coplanar
PCBs
may
dominate
,
in
induction
of
dioxin­
like
responses.
Because
of
the
variety
of
substances
and
congeners
of
USEPA,
2003d
112
substances
that
activate
the
Ah
receptor,
activities
of
mixtures
are
usually
expressed
as
toxic
equivalents
(
TEQs)
(
Safe,
1990).

Dioxin­
like
compounds
cause
a
large
variety
of
human
diseases
in
addition
to
cancer,
such
as
heart
disease,
hypertension
and
diabetes
(
Pesatori
et
al.,
1998;
Vena
et
al.,
1998).
Dioxins
are
immunosuppressive
agents,
and
endocrine
disruptors
of
both
thyroid
and
sex
steroid
function
(
Birnbaum,
1995;
NAS
2003).
Risk
for
some
of
these
diseases
appears
to
be
elevated
at
concentrations
in
humans
that
are
not
much
greater
than
ambient
background
in
the
population,
which
is
evidence
that
it
is
extremely
important
to
reduce
human
exposure
(
NAS
2003).

At
present,
sewage
sludge
that
is
land
applied
is
the
second
greatest
contributor
to
release
of
dioxin
and
dioxin­
like
compounds
to
the
environment
in
the
United
States
(
Dwain
Winter,
USEPA,
presentation
to
the
NAS
Committee
on
Dioxin
and
Dioxin­
like
Compounds
in
the
Food
Supply:
Strategies
to
Decrease
Exposure,
2
April
2002).
With
the
major
reduction
in
releases
of
dioxin
from
incineration,
thanks
to
the
Clean
Air
Act,
only
backyard
burn
barrels
release
a
greater
amount
of
dioxin­
like
compounds,
as
indicated
by
g
TEQdfwho98/
year.
This
report
indicates
that
total
dioxin
TEQ
sources
were
1,106g,
and
that
sewage
sludge
contributed
76.6
g
or
6.9%
of
the
total
dioxins.
In
addition
sewage
sludge
incineration
contributes14.8
g
TEQdfwho98/
year
to
the
air,
which
is
1.3%
of
total
emissions.
There
are
multiple
sources
of
dioxin­
like
compounds
that
get
into
biosolids,
ranging
from
industrial
discharges
to
waste
water
from
washing
machines
and
even
showers,
reflecting
dioxins
in
clothing
(
Horstmann
and
McLachlan,
1995).
Application
of
biosolids
to
agricultural
fields
has
been
demonstrated
to
cause
accumulation
of
dioxin­
like
compounds
in
both
soils
and
in
the
milk
from
cows
grazing
on
the
fields
(
McLachlan
et
al.,
1994).
In
a
later
study
McLachlan
et
al.(
1996)
found
that
dioxins
and
furans
persisted
in
soils,
such
that
over
50%
of
the
dioxins
and
furans
applied
to)
a
field
as
sewage
sludge
in
1972
were
still
present
in
1990.

Because
of
the
significant
toxicity
to
humans
of
dioxin­
like
compounds,
and
the
fact
that
land
application
of
sewage
sludge
is
the
second
largest
source
of
environmental
contamination
with
dioxins,
it
is
of
urgent
importance
that
it
be
regulated.

PCBs:
Unlike
dioxins
and
furans,
which
are
primarily
products
of
combustion,
PCBs
were
manufactured
from
the
late
1920s
until
the
mid
1970s,
and
had
a
variety
of
valuable
uses
as
hydraulic
fluids,
in
transformers,
paints,
floor
and
ceiling
tiles
and
many
other
uses.
Their
manufacture
and
use
was
banned
in
1977
because
of
evidence
that
they
were
persistent
in
the
environment,
wildlife
and
humans.
There
are
209
PCB
congeners,
depending
upon
the
number
and
position
of
chlorines
around
the
biphenyl
ring.

While
the
coplanar
PCBs
are
dioxin­
like,
and
are
activators
of
the
Ah
receptor,
most
of
the
209
PCB
congeners
do
not
significantly
bind
to
the
Ah
receptor.
Yet
these
non
­
dioxin
like
PCBs
have
significant
toxic
actions
mediated
via
different
mechanisms.
As
with
lead,
PCBs
cause
decrements
in
IQ
and
neurobehavioral
changes,
such
as
shortened
attention
span
and
reduced
ability
to
deal
with
frustration.
Non­
dioxin
PCBs
also
cause
thyroid
and
sex
steroid
endocrine
disruption,
cancer
and
immune
system
suppression
by
different
mechanisms
than
those
of
the
USEPA,
2003d
113
coplanar
congeners
(
Carpenter,
1998).
ATSDR
reports
that
the
average
serum
PCB
levels
in
persons
without
unusual
sources
of
exposure
are
0.9­
1.5
ppb.
As
mentioned
above
the
studies
of
Schell
et
al.
(
2002)
document
physiological
effects
of
concentrations
of
PCBs
in
this
range.
As
with
dioxin­
like
substances,
this
fact
makes
it
extremely
important
that
exposure
to
PCBs
be
reduced.
While
manufacture
of
PCBs
in
the
United
States
and
most
other
countries
ceased
in
the
mid
1970s,
these
are
very
persistent
compounds
both
in
the
environment
and
in
the
human
body.
While
levels
in
the
population
are
declining
slowly
over
time,
our
understanding
of
how
toxic
these
substances
are
has
been
increasing,
such
that
in
many
regards
they
are
more
clearly
a
public
health
hazard
today
than
was
realized
30
years
ago.
Any
increment
of
exposure
should
be
avoided.

There
is
one
prior
study
that
demonstrates
elevated
PCB
exposure
in
biosolid
users.
Baker
et
231.(
1980)
reported
that
after
application
of
biosolids
to
domestic
gardens,
serum
PCB
levels
were
positively
associated
with
garden
care
and
negatively
associated
with
wearing
gloves
while
gardening.

It
is
likely
that
the
primary
exposure
pathway
of
dioxins
and
PCBs
to
humans
from
surface
application
of
biosolids
is
the
adherence
of
the
biosolids
to
forage
or
pasture
crops
which
are
then
eaten
by
animals
used
for
human
consumption
(
Chaney
et
al.,
1996;
NRS
2003).
However,
another
important
pathway
is
unintentional
direct
ingestion
of
contaminated
biosolids
by
children
(
Stanek
and
Calabrese,
1995).

In
the
National
Sewage
Sludge
Survey,
EPA
(
1995)
reports
no
detectable
levels
of
PCB
congeners
1016,
1221,
1232
or
1242
were
found
in
any
of
the
198
tested
samples.
The
remaining
congeners
­
PCB
1248,
1254,
and
12610
­
were
found
to
be
above
the
minimum
detectible
level
in
about
10
percent
of
the
biosolids
samples.
This
statement
reflects
an
inexcusable
ignorance
of
what
PCBs
are.
The
numbers
listed
are
not
congeners,
but
Aroclor
mixtures,
each
of
which
contains
many
different
PCB
congeners.
In
addition
Aroclor
analysis
is
inaccurate
and
usually
has
a
very
poor
detection
level.
Since
the
different
PCB
congeners
cause
very
different
health
outcomes,
it
is
totally
inappropriate
for
the
risk
assessment
to
be
based
only
on
Aroclor
patterns.

Other
halogenated
compounds:
Pesticides,
and
particularly
chlorinated
pesticides,
are
also
contaminants
of
concern.
Like
dioxins
and
PCBs,
these
substances
are
persistent
and
lipophilic.
The
organochlorine
pesticides
have
not
been
manufactured
in
recent
years,
but
they
are
still
found
in
significant
concentrations
in
many
media,
including
sewage
sludge.
Most
of
pesticides
manufactured
today
in
the
US
are
not
as
persistent,
but
like
the
organochlorine
pesticides
exposure
elevates
risk
for
immune
suppression,
birth
defects,
cancer,
reproductive
abnormalities
and
other
diseases
(
Dich
et
al.,
1997;
Sharp
et
al.,
1986).
In
addition
considerable
attention
is
now
being
given
to
polybrominated
diphenyl
ethers,
used
as
flame
retardards,
as
these
compounds
are
structurally
similar
to
PCBs
and
have
similar
toxicities.
They
are
persistent,
lipophilic
and
they
bioaccumulate.
The
European
practice
of
setting
limits
on
biosolid
concentrations
of
all
halogenated
compounds
is
a
good
way
in
which
to
prevent
exposure
to
a
variety
of
persistent
compounds
of
varying
degree
of
toxicity,
and
is
recommended
for
use
by
EPA.
USEPA,
2003d
114
Other
organic
substances:
Several
European
countries
have
established
standards
for
other
specific
organics
contaminants.
The
most
stringent
standards
are
in
Denmark.
Denmark
has
a
standard
of
50
mg/
kg
dry
weight
for
di(
2­
ethylhexyl)
phthalate.
Phthalates
are
plasticizers
and
are
known
endocrine
disruptors.
They
currently
have
a
standard
of
10
mg/
kg
dry
weight
for
nonylphenol
and
nonylphenolethoxylates,
another
class
of
endocrine
disruptors
used
as
surfactants.
Austria,
Denmark,
France
and
Sweden
regulate
polyaromatic
hydrocarbons
(
PAHs)
as
a
general
class,
or
in
some
cases
regulate
specific
PAHs
such
as
fluoranathene,
benzo(
b)
fluoranthene
and
benzo(
a)
pyrene.
It
is
particularly
interesting
that
France
specifically
regulates
PAHs
only
when
applied
directly
to
pasture
land.

While
these
are
certainly
toxic
substances
with
human
health
effects
(
especially
endocrine
disruption,
and
in
the
case
of
PAHs,
cancer),
in
the
author's
opinion
biosolids
constitute
such
a
minor
portion
of
exposure
that
regulation
in
this
medium,
while
desirable,
is
much
less
of
a
priority
than
for
the
substances
listed
above.
It
has
been
reported,
for
example,
that
the
major
route
of
exposure
of
humans
to
PAHs
is
through
the
diet,
and
that
cereals
and
vegetables,
rather
than
meats,
are
the
major
source.
The
transport
to
the
cereals
and
grains
is
primarily
via
air
(
Phillips,
1999).
This
indicates
that
contaminated
biosolids
pose
a
likely
route
of
exposure,
but
one
that
is
much
less
than
that
from
other
combustion
sources.
These
compounds
have
moderate
persistence,
but
are
not
nearly
as
persistent
as
metals
or
chlorinated
compounds.
Importance
of
use
of
the
precautionary
principle:
The
precautionary
principle
is
very
applicable
to
the
question
of
what
contaminants
should
be
regulated
in
biosolids.
If
a
substance
is
toxic,
persistent
and
bioaccumulates,
and
if
there
is
a
possibility
that
it
will
get
into
humans
either
via
the
food
chain
or
particularly
into
children
who
have
direct
contact
with
it,
steps
should
be
taken
to
prevent
this
exposure
from
occurring.

There
are
several
important
actions
that
can
be
taken
to
reduce
human
exposure
to
contaminants
in
biosolids.
The
most
obvious
is
regulations
to
prevent
surface
soil
application
of
any
biosolid
that
contains
excessive
amounts
of
persistent
and
toxic
substances.
Those
substances
that
are
not
persistent
are
of
concern
as
well,
but
the
duration
of
time
over
which
human
contact
should
be
limited
is
much
less
when
the
toxic
substances
degrade
into
non­
toxic
compounds
relatively
rapidly
in
the
environment.
In
the
author's
judgment,
this
consideration
requires
additional
regulation
of
chromium
and
the
general
category
of
persistent
organic
pollutants
(
POPS)
as
defined
by
the
Stockholm
treaty.
The
exemption
of
substances
no
longer
manufactured
in
the
US
should
be
eliminated,
since
these
compounds,
especially
the
persistent
chlorinated
compounds,
remain
a
major
public
health
hazard.

There
should
also
be
regulation
as
to
the
use
of
land
on
which
biosolids
are
placed.
One
major
concern
is
biosolid
application
to
land
used
either
for
pasture
or
growth
of
forage
food
for
livestock
that
will
be
consumed
by
humans.
Contaminates
from
the
biosolids
pill
deposit
on
leaves
of
plants,
and
if
these
are
consumed
by
animals
the
contaminants
will
be
passed
into
the
human
food
chain.
Grazing
livestock
also
ingest
significant
amounts
of
soils.
Application
on
to
fields
on
which
corn
or
soy
beans
are
grown
poses
much
less
danger
of
accumulation,
since
the
grains
are
enclosed
in
a
covering
that
is
removed
at
harvest.
USEPA,
2003d
115
The
use
of
biosolids
on
lawns
and
gardens
should
be
immediately
stopped.
These
are
the
sites
where
exposure
to
children
is
not
only
possible,
but
indeed
likely.
It
is
amazing
to
the
author
that
the
1995
EPA
Guide
to
the
Biosolids
Risk
Assessments
for
the
EPA
Part
503
Rule
shows
photos
of
lawns
before
and
after
application
of
biosolids,
basically
recommending
such
use.
It
is
true
that
biosolids
contain
nutrients
for
lawns
and
gardens,
but
there
are
many
other
sources
of
these
nutrients
that
avoid
any
possibility
of
exposure
of
children,
household
pets
and
even
the
adults
to
contaminants.
Use
on
lawns
and
gardens
will
also
result
in
immediate
exposure
to
substances
that
may
not
be
as
persistent
but
still
are
toxic.
Therefore,
application
of
biosolids
onto
lawns
and
gardens
is
unwise
even
in
the
absence
of
the
more
persistent
contaminants.

It
is
certainly
true
that
the
alternatives
to
land
application
of
biosolids
are
not
without
potential
hazards
as
well.
EPA's
data
shows
dioxin
production
from
biosolid
incineration.
Landfills
have
the
potential
to
leach
and
allow
contaminates
to
migrate.
There
is
certainly
benefit
in
recycling
organic
materials
that
provide
nutrients
to
plants.
However,
priority
must
be
to
protect
human
health.

Summary
and
Conclusions:
There
are
a
number
of
serious
deficiencies
in
the
current
EPA
regulations
regarding
biosolids
application
and
their
whole
risk
assessment
process.
These
are:

1.
Current
regulations
for
nine
metals
are
less
stringent
than
those
in
other
developed
countries
and
do
not
adequately
protect
public
health.

2.
The
current
regulation
which
accepts
substances
no
longer
manufactured
in
the
US
from
regulation
should
be
eliminated.
No
regulation
is
currently
in
place
for
several
persistent
toxic
chemicals,
including
chromium,
dioxins/
furans,
PCBs
and
other
halogenated
persistent
pollutants.
These
are
compounds
of
great
toxicity
and
are
present
in
biosolids,
with
consequent
threats
to
human
health.
Such
regulation
should
be
implemented.

3.
The
rule
that
only
those
contaminates
present
in
greater
than
5
or
10%
of
biosolids
should
be
considered
for
regulation
is
not
protective
of
human
health,
and
should
be
changed
to
allow
for
regulation
of
persistent
and
toxic
substances
that
may
be
present
in
biosolids
on
a
very
local
level
because
of
a
particular
industry.

4.
Restrictions
should
be
placed
on
lands
on
which
biosolid
application
is
appropriate.
EPA
should
cease
to
allow
and
even
to
support
application
of
biosolids
of
any
form
onto
lawns
and
gardens
and
onto
farm
lands
used
for
pasture
and/
or
forage
crop
production
for
animals
used
for
human
food.

5.
The
use
of
reference
doses
and
the
assumption
of
there
being
a
threshold
for
non
­
cancer
outcomes
is
not
justified
and
results
in
and
underestimation
of
the
importance
of
various
non­
cancer
endpoints
especially
neurobehavioral
and
endocirine
disruption
effects.
In
the
author's
estimation
the
risk
assessment
process
would
be
more
protective
of
human
health
using
USEPA,
2003d
116
something
comparable
to
cancer
slope
factors
and
assuming
no
threshold
for
perturbation
of
physiologic
function.

Response
With
respect
to
sewage
sludge
standards
of
other
countries,
please
see
the
EPA
response
to
Comment
Log
No.
25
in
this
section.
The
issue
of
dioxin
and
dioxin­
like
compounds
in
sewage
sludge
has
been
addressed
by
EPA's
recent
decision
that
numerical
standards
for
these
compounds
in
land
applied
sewage
sludge
are
not
warranted
(
Federal
Register
Notice
dated
October
24,
2003).
All
other
portions
of
these
comments
are
addressed
by
referring
to
the
Summary
Response
of
this
section
and
by
the
previous
EPA
responses
in
the
Survey,
Exposure,
and
Risk
Assessment
sections
of
this
document.
Note:
Chromium
was
originally
regulated
as
part
of
the
Round
One
Standards
when
they
were
published
in
1993.
Based
on
a
judicial
challenge
in
1994
in
which
the
Plaintiffs
successfully
argued
that
chromium
posed
an
insignificant
risk
to
public
health
from
its
presence
in
land
applied
sewage
sludge,
all
chromium
numerical
standards
were
deleted
from
the
Part
503
Standards
for
land
applied
sewage
sludge.

With
respect
to
the
use
of
sewage
sludge
on
lawns
or
home
gardens,
EPA
is
considering
amending
the
Part
503
Standards
in
the
future
to
require
that
sewage
sludge
used
in
this
manner
be
in
conformance
to
the
pollutant
concentration
standards
(
Table
3
of
Subpart
B
of
the
Part
503
Standards).
This
amendment,
when
enacted,
will
require
sewage
sludge
used
on
lawns
and
home
gardens
to
be
of
the
highest
quality
under
the
Part
503
Standards.
In
the
mean
time,
the
current
numerical
standards
that
are
in
place
for
such
sewage
sludge
used
in
this
manner
are
judged
to
be
protective
of
human
health.

Comments
of
Dr.
Peter
L.
deFur
The
503
rule
sets
numerical
regulatory
standards
for
only
10
of
more
than
200
chemicals,
not
considering
the
remaining
chemicals
due
to
low
detection
frequency,
low
concentration
in
the
sludge,
or
insufficient
data
on
toxicity
or
fate
and
transfer
in
the
environment
(
according
to
the
503
rule).
These
criteria
are
no
longer
valid,
as
concluded
by
NRC
(
2002)
and
literature
publications.
Furthermore,
the
original
1989
survey
is
no
longer
sufficiently
current
to
use
as
a
basis
for
this
important
regulation.
Finally,
the
risk
assessment
procedures
used
in
1989
are
no
longer
up
to
date.
The
rule
needs
to
protect
fetuses
from
multiple
chemical
exposures
that
are
present
during
development
and
then
in
childhood
from
other
sources.
The
evaluation
of
chemicals
should
be
based
on
the
combined
exposure
to
the
full
range
of
chemicals
and
pathogens
in
sewage
sludge.

Response
Please
see
the
response
to
David
Carpenter
in
this
set
of
comments.
Also,
please
see
the
EPA
response
to
Comment
Log
No.
36
in
this
section.

Municipal
Wastewater
Treatment
Plants
EPA
Log
#
14:
Metro
Wastewater
Reclamation
District
Comment
The
Metro
District
agrees
with
EPA's
approach
for
addressing
regulatory
activities
issues
raised
by
the
NRC
report.
Specifically,
the
District
agrees
with
EPA
that
revised
standards
USEPA,
2003d
117
for
molybdenum
should
be
considered;
however,
any
proposed
standards
should
be
based
upon
the
most
up­
to­
date
scientific
information
and
a
newly
conducted
risk
assessment.

EPA
should
assess
whether
or
not
it
is
necessary
to
restrict
the
sale
or
distribution
of
Class
A
biosolids
in
amounts
less
than
one
metric
ton
unless
the
biosolids
meet
the
exceptional
quality
criteria.
If
distribution
of
Class
A
biosolids
that
do
not
meet
the
exceptional
quality
requirements
in
amounts
less
than
one
metric
ton
is
not
a
common
practice,
promulgation
of
new
requirements
to
address
this
limited
practice
may
not
be
needed.

The
Metro
District
agrees
with
EPA's
assessment
of
the
need
to
address
the
NRC
report's
recommendations
related
to
"
Standard
Management
Practices."
Biosolids
production
and
land
application
operations
vary
significantly
around
the
country.
The
District
believes
that
attempting
to
codify
practices
beyond
those
already
set
forth
in
40
CFR
Part
503
is
not
only
unnecessary
but
also
unwise.
The
variety
of
options
that
would
have
to
be
included
in
a
revised
regulation
would
be
so
numerous
it
would
be
nearly
impossible
for
the
average
biosolids
producer
or
land
application
manager
to
identify
which
practices
to
utilize.
Enforcement
also
would
be
virtually
unworkable.
Allowable
biosolids
production
methods
and
land
application
practices
should
be
approved
based
on
sound
science
and
land
management
principles
that
have
been
proven
over
time.

Response
Please
see
the
Summary
Response
to
this
section
of
this
document.
Also
please
see
the
EPA
response
to
Comment
Log
Nos.
43
(
David
Carpenter)
and
25.

EPA
Log
#
19:
Metropolitan
Water
Reclamation
District
of
Greater
Chicago
Comment
On
page
17390
in
Section
VIII.
G.
l.,
the
notice
cites
an
NRC
recommendation
for
the
"
elimination
of
exemptions
for
nutrient
management
and
site
restrictions
for
land
applied
EQ
biosolids."
This
recommendation
was
not
addressed
by
EPA
in
their
response
on
page
17391.
If
the
nutrient
management
exemption
is
eliminated
for
EQ
biosolids,
it
can
have
an
impact
on
our
biosolids
management
program
and
perhaps
the
biosolids
management
programs
of
other
POTWs.
Currently
under
Part
503,
the
Metropolitan
Water
Reclamation
District
of
Greater
Chicago
(
Chicago)
is
exempt
from
applying
EQ
biosolids
to
land
at
N­
based
agronomic
rates.
This
enables
Chicago
to
apply
biosolids
at
reclamation
rates
at
the
Fulton
County,
Illinois
site
and
at
soil
conditioning
rates
in
the
Controlled
Solids
Distribution
Program.
These
practices
comply
with
the
Part
503
regulations
and
are
also
permitted
by
the
Illinois
Environmental
Protection
Agency
(
IEPA).
This
practice
has
been
explained
to
EPA
Region
V
in
every
annual
biosolids
report
since
the
first
report
in
February
1994.
This
explanation
is
found
in
Appendix
I
­
Biosolids
Management
Programs
of
the
Metropolitan
Water
Reclamation
District
of
Greater
Chicago
Under
40
CFR
Part
503
(
January
28,1994
letter
to
Michael
J.
Mikulka
of
USEPA
Region
V).

Technically,
if
this
exemption
is
eliminated,
Chicago
would
need
to
obtain
case­
by­
case
approval
for
greater
than
agronomic
loading
rates
from
the
permitting
authority,
which
is
currently
EPA
Region
V,
since
the
IEPA
has
not
been
delegated
for
Part
503
authority.
Elimination
of
this
exemption
may
not
be
difficult
for
our
Fulton
County
program
because
it
has
biosolids
USEPA,
2003d
118
continuously
applied
in
agricultural
utilization
and
it
is
a
managed
site.
However,
for
the
Controlled
Solids
Distribution
Program,
we
may
be
faced
with
obtaining
site
specific
loading
rates
from
EPA
Region
V
for
each
project
site,
which
would
slow
our
response
time
to
customer
requests
for
biosolids
utilization
in
the
metropolitan
area
on
numerous
sites.
It
is
likely
that
EPA
Region
V
does
not
have
the
resources
to
be
responsive
to
such
a
demand.

Response
Please
see
the
Summary
Response
to
this
section
of
this
document.

Unknown
EPA
Log
#
34:
Anonymous
Comment
Alternative
to
be
considered
Two
changes
to
the
existing
program
that
would
begin
a
process
to
improve
the
science
and
public
perception
would
include
:
1)
A
pre­
application
permitting
program
on
a
site
specific
basis.
2)
A
volume
based
fee
remittance
program
that
would
provide
the
funding
to
be
used
to
offset
the
permitting
program
and
to
be
designated
toward
research
and
analytical
methods
development.

The
concept
of
obtaining
a
permit
prior
to
performing
an
activity
is
a
standard
practice
for
the
EPA.
In
fact
the
two
other
sewage
sludge
management
methods
(
incineration
and
land­
filling)
both
require
permits
prior
to
the
construction.
Land
application
is
an
activity
which
involves
environmental
risk.
The
public
deserves
be
aware
of
the
activity
PRIOR
to
the
activity
taking
place.
Public
comment
should
be
allowed
on
a
case
by
case
basis.
Public
review
and
comment
in
the
present
situation
is
not
possible
or
limited
at
best.
The
elements
of
a
permitting
program
would
include
:
1)
An
application
submission
from
the
source
of
the
sewage
sludge.
2)
Federal
or
State
program
review
and
a
preliminary
determination
(
or
rejection
of
the
application
if
it
is
incomplete).
3)
Draft
permit
terms
and
conditions,
and
a
definite
term
to
the
duration
of
the
land
application
activity.
4)
The
public
notice
of
the
availability
of
the
preliminary
determination,
and
the
draft
terms
and
conditions.
5)
An
opportunity
to
submit
comments
to
the
permit
authorities.
6)
State
or
Federal
review
to
the
of
the
comments,
and
the
requirement
of
a
public
hearing
if
significant
issues
are
identified
during
the
public
comment
period.
7)
Addressing
of
the
public
comments
and
the
final
decision
of
the
permissibility
of
proposed
application.
8)
Issuing
a
final
permit
with
terms
and
conditions.
9)
Federal
or
State
conducted
inspections.
10)
Prompt
review
and
enforcement
of
any
inspection
violations
or
public
complaints.

The
permit
application
would
include:
1)
A
detailed
description
of
the
properties
that
will
or
may
receive
the
land
application
of
sewage
sludge.
2)
The
source
and
volume
of
the
sewage
sludge
to
be
applied.
3)
The
concentrations
of
toxic
pollutants,
and
pathogens
known
to
be
present
in
the
sewage
sludge.
4)
Proposed
and
maximum
Agronomic
application
rate.
5)
Temporary
storage
sites
during
floods,
frozen
soil,
snow
covered
soil
conditions
or
other
events
that
prevent
the
immediate
application
of
the
sewage
sludge.
6)
Management
methods
proposed
to
prevent
public
access
restriction
requirements
required
for
class
B
application
of
material.
7)
Other
information
necessary
to
demonstrate
to
the
public
that
the
project
will
not
endanger
the
public
or
environment.
USEPA,
2003d
119
Response
Please
see
the
Summary
Response
in
this
section
of
this
document
and
the
EPA
response
to
Comment
Log
Nos.
8
and
25
with
respect
to
the
issue
of
consideration
of
local
sitespecific
conditions
in
the
design
of
protective
standards
and
National
Design
Standards,
respectively.
For
EPA's
position
and
responses
to
Part
503
Program
implementation
vis
a
vis
permit
issuance,
oversite,
compliance
and
enforcement,
please
refer
to
today's
Federal
Register
Notice
that
addresses
this
issue
in
Section
VII
B,
project
No.
1.
and
the
EPA
responses
in
the
section
on
Biosolids
Management
in
this
document.

Land
Application
Company
EPA
Log
#
26:
Synagro
Technologies,
Inc.

Comment
The
NAS/
NRC
report
recommended
that
EPA
revise
its
regulatory
approach
by
considering
biosolids
protocols
used
by
other
nations,
adoption
of
national
standard
treatment
design
criteria,
refinement
of
stabilization
controls
using
metabolic
techniques,
develop
molybdenum
standards,
develop
a
QMRA
and
further
regulate
Class
A
biosolids.
EPA
has
responded
to
each
of
these
recommendations
in
a
positive
fashion.

°
Current
regulatory
framework
is
effective
to
protect
human
health
and
the
environment.
No
need
for
major
changes.

°
Any
regulatory
changes
should
be
based
either
on
known
technologies
or
results
of
a
risk
assessment.

°
All
regulatory
changes
should
go
through
appropriate
rulemaking
procedures.

Response
EPA
generally
agrees
with
these
comments.
In
response
to
the
first
bullet
above,
see
the
Summary
Response
to
this
section
of
this
document.

Association
EPA
Log
#
30:
Tri­
TAC
Comment
Regulatory
Activities
Tri­
TAC
agrees
with
EPA's
approach
for
addressing
the
regulatory
issues
raised
by
the
NRC
Report.
Specifically,
Tri­
TAC
agrees
with
EPA
that
revised
standards
for
molybdenum
should
be
considered.
However,
any
proposed
standards
should
be
based
on
the
most
up­
to­
date
scientific
information
and
a
newly
conducted
risk
assessment.

Tri­
TAC
understands
that
the
NRC
is
recommending
that
all
biosolids
products
sold
or
given
away
in
bags
or
other
containers
should
be
exceptional
quality
(
EQ).
Tri­
TAC
also
understands
that
by
eliminating
the
non­
EQ
Table
4
alternative,
EPA
would
essentially
be
prohibiting
selling
or
giving
away
biosolids
products
in
bags
or
other
containers
weighing
less
than
one
metric
ton
unless
those
products
met
the
EQ
standard.
Before
making
any
final
regulatory
decision,
Tri­
TAC
USEPA,
2003d
120
encourages
EPA
to
confirm
whether
there
are
any
biosolids
products
being
sold
that
conform
to
the
Table
4
alternative
and
to
document
their
justification
for
removing
the
alternative.

Tri­
TAC
agrees
with
EPA
that
states
have
a
better
understanding
of
local
conditions
and,
therefore,
are
in
the
best
position
to
establish
additional
management
practices
to
enhance
the
protectiveness
of
the
Part
503
standards
as
needed.

Tri­
TAC
endorses
the
NRC
Report's
recommendation
to
study
the
correlation
between
pathogen
destruction
and
indicator
organism
levels
in
biosolids
from
various
treatment
processes,
such
as
anaerobic
and
aerobic
digestion,
and
lime
stabilization.
Studies
of
this
type
will
provide
data
that
will
either
substantiate
the
protective
nature
of
the
Class
A
and
Class
B
pathogen
destruction
criteria,
or
show
there
is
a
need
to
revise
them.

Response
EPA
generally
agrees
with
these
comments.
See
EPA's
response
to
Comment
Log
No.
8
in
this
section
of
this
document.
EPA
refers
the
reader
to
EPA's
response
to
David
Carpenter
with
respect
to
the
molybdenum
issue
(
Comment
Log
No.
43
in
this
section).

EPA
Log
#
27:
California
Farm
Bureau
Federation
Comment
The
relevant
focus
for
protecting
persons
from
health
risks
associated
with
the
use
of
biosolids
must
be
the
rural
communities
and
environment
where
the
biosolids
are
applied,
not
the
urban
"
public
at
large,"
which
generates
but
largely
does
not
land
apply
biosolids.

The
USEPA's
Part
503
regulations
ostensibly
are
designed
to
protect
the
"
public
at
large"
from
the
health
risks
and
effects
of
the
land
application
of
sewage
sludge.
However,
as
the
California
State
Water
Resources
Control
Board
(
CSWRCB)
noted
in
its
2001
environmental
impact
report
(
EIR)
in
support
of
its
proposed
statewide
minimum
standards
for
the
land
application
of
sewage
sludge
(
currently
under
review
pursuant
to
a
court
order),
the
Part
503
regulations
were
based,
in
part,
on
a
"
willingness
to
accept
some
health
risk
to
support
the
reuse
of
sewage
sludge."
Yet
the
generally
urban
"
public
at
large"
is
not
at
any
risk
from
the
land
application
of
sewage
sludge
since
the
vast
majority
of
sewage
sludge,
and
all
risks
attendant
to
it,
although
generated
by
urban
communities,
is
shipped
to
and
disposed
in
rural,
agricultural
communities.

Hence,
the
acceptance
of
"
some
health
risk"
by
the
USEPA
on
behalf
of
the
general
public
comes
almost
exclusively
at
the
expense
of
farmers
and
their
communities
where
the
sewage
sludge
is
applied.
As
the
NRC
recently
confirmed:

To
date,
epidemiological
studies
have
not
been
conducted
on
exposed
populations
such
as
biosolids
appliers,
farmers
who
use
biosolids
on
their
fields,
and
communities
near
land­
application
sites.

There
is
significant
disagreement
in
the
scientific
community
over
the
validity
and
completeness
of
the
USEPA's
current
risk
assessment,
particularly
its
incomplete
analyses
of
long­
term
effects
on
soils
and
crops.
Much
of
the
disagreement
arises
from
recognized
deficiencies
in
the
USEPA's
USEPA,
2003d
121
analyses,
mostly
due
to
the
lack
of
necessary
information,
but
also
the
result
of
policy
decisions
that
follow
a
less,
not
more
conservative
approach
to
regulation.
Under
this
approach,
looser
regulations
are
adopted,
even
though
it
is
acknowledged
that
long­
term
consequences
are
unknown,
with
vague
assurances
that
controls
can
be
increased
in
the
future
when
better
data
is
collected.

Unfortunately,
more
stringent
controls
will
come
too
late
for
the
people
exposed
to
those
consequences:
the
farmers
and
their
communities.
The
USEPA's
policies
and
assumptions
underlying
its
risk
assessment
and
regulations
must
be
reexamined
to
properly
reflect
the
risks
faced
by
the
much
smaller,
rural
populations
where
the
majority
of
urban
generated
sewage
sludge
is
transported
and
land
applied.

The
USEPA
has
acknowledged
that
it
lacked
sufficient
data
to
develop
conservative
regulatory
standards
to
protect
exposed
individuals
and
the
environment.

The
USEPA's
approach
to
sewage
sludge
regulation
"
entails
developing
maximum
permissible
pollutant
loading
limits
and/
or
maximum
permissible
pollutant
concentration
for
the
soil.
It
necessitates
a
more
complete
understanding
of
pollutant
chemistry,
health
hazards,
pathways
to
exposure,
and
sophisticated
modeling
techniques."
Unfortunately,
the
USEPA
was
unable
either
to
adequately
model
these
issues
or
to
find
sufficient
data
upon
which
to
develop
maximum
permissible
loading
limits.

First,
the
USEPA
recognized
it
did
not
have
sufficient
information
to
set
standards
for
all
pollutants
in
sewage
sludge,
meaning
that
some
pollutants
which
could
pose
public
health
and
environmental
risks
would
go
unregulated.

The
scope
of
the
Part
503
standards
is
necessarily
constrained
by
the
adequacy
of
information
on
sewage
sludge
pollutants
and
means
of
use
or
disposal
.
.
.

Today's
rule
establishes
standards
for
these
pollutants
and
sludge
use
or
disposal
methods
for
which
the
Agency
had
sufficient
information
to
establish
protective
numerical
limits,
management
practices,
and
other
requirements.
The
Agency
recognizes
that
today's
rule
may
not
regulate
all
pollutants
in
sewage
sludge
that
may
be
present
in
concentrations
that
may
adversely
affect
public
health
and
the
environment.

Rather
than
waiting
for
more
complete
information,
however,
the
USEPA
promulgated
standards
only
"
for
those
pollutants
and
use
or
disposal
practices
for
which
sufficient
information
exists."
Yet,
little
information
was
available
even
for
this
constrained
review.
In
fact,
the
USEPA
acknowledged
that
it
could
not
find
any
studies
that
investigated
the
effects
of
heavy
metals
in
sewage
sludge
on
plants.

The
USEPA,
therefore,
was
forced
to
use
short­
term
experimental
studies
analyzing
specific
metals
effects
on
a
limited
number
of
crops.
Most
of
the
available
data
was
for
corn,
which
is
not
very
sensitive
to
metals
concentrations
in
soil.
Data
on
more
sensitive
crops
was
scarce.
As
a
USEPA,
2003d
122
result,
the
USEPA
used
data
for
just
a
few
crops
to
extrapolate
phytotoxicity
effects
for
all
crops.
This,
even
though
the
USEPA
knew
of
the
significant
uncertainties
in
trying
to
develop
such
relationships:

The
phytotoxicity
assessment
was
based
on
the
relationships
between
sludge
application
rate
and
tissue
residue,
between
tissue
residues
and
reduction
in
growth
and
reduction
in
yield.
The
relationship
between
reduction
in
growth
and
reduction
in
yield
is
particularly
uncertain.
The
uncertainties
will
vary
with
chemical,
crop
species,
and
toxic
endpoint;
the
best
data
were
available
for
zinc,
corn,
and
growth
reduction.

Regardless,
the
USEPA
proceeded
ahead
using
two
different
approaches
to
determine
limits
for
metals
known
to
cause
phytotoxicity
and
extrapolating
those
results
to
all
crops.
The
first
approach
was
to
use
data
on
corn,
which
is
classified
as
a
crop
that
is
"
very
tolerant"
of
heavy
metals
in
the
soil.
The
USEPA
selected
a
50%
yield
reduction
as
the
threshold
for
presuming
phytotoxicity
had
occurred.
The
USEPA
acknowledged,
however,
that
a
50%
yield
reduction
assumption
was
subjective,
and
said
that
ideally,
such
thresholds
should
be
determined
from
long­
term
field
studies
in
which
reduction
in
yield
was
assessed
subsequent
to
the
application
of
sewage
sludge.
The
USEPA
obviously
failed
to
consult
with
farmers
who
gladly
would
have
told
the
USEPA
that
even
a
10%
reduction
in
the
crop
yield
is
unacceptable.

The
second
approach
tried
by
the
USEPA
was
to
review
the
available
literature
for
information
on
plant
tissue
concentrations
associated
with
potential
phytotoxicity
in
sensitive
crops
(
leafy
vegetables).
However,
little
information
was
available.
For
example,
no
data
on
chromium
effects
on
sensitive
crops
was
available,
so
the
first
approach,
using
the
relatively
metal
tolerant
corn
data,
was
used.
For
copper,
the
USEPA
relied
on
data
for
bush
beans
and
snap
beans,
which
similarly
are
not
the
most
sensitive
species
of
crops.

For
both
its
approaches,
however,
the
USEPA
did
not
have
data
on
long­
term
studies.
Rather,
"[
s]
hort­
term
experiments
were
used
to
develop
a
plant
concentration
of
pollutant
associated
with
phytotoxicity
.
.
.
".

The
bottom
line
is
that
the
USEPA
regulations
cover
only
a
small
number
of
pollutants
in
sewage
sludge
and
the
concentration
limits
for
those
few
pollutants
are
based
on
extrapolations
of
limited
data
with
no
knowledge
of
the
long­
term
consequences.
Not
surprisingly,
the
USEPA's
recommendations
have
caused
the
relevant
scientific
community
to
voice
their
concerns.
As
the
Cornell
Waste
Management
Institute
discussed:

Excessive
accumulation
of
certain
metals,
such
as
copper,
zinc
and
nickel
reduces
crop
yields.
We
need
to
assess
not
only
short­
term
benefits,
but
long­
term
risks
of
yield
reduction
due
to
accumulation
of
contaminants
over
time.
This
pathway
(
Pathway
8,
Table
3)
was
evaluated
by
USEPA
in
the
risk
assessment
and
has
also
been
considered
by
agronomists
at
the
land
grant
universities
in
the
northeast
(
Pennsylvania
State
University,
1985).
The
cumulative
limits
for
copper,
nickel
and
zinc
in
the
Part
503
regulations
are
approximately
10
times
those
recommended
by
the
northeast
soil
scientists.
USEPA,
2003d
123
Further,
the
subsequent
investigation
and
collection
of
data
to
verify
the
USEPA's
assumptions
have
demonstrated
their
fallacy.
For
example,
in
its
risk
assessment,
the
USEPA
based
its
300
ppm
concentration
limit
for
lead
in
sewage
sludge
on
the
assumption
(
challenged
at
the
time
by
parties
commenting
on
the
risk
assessment),
that
a
safe
threshold
for
lead
concentrations
in
children
did
exist.
The
USEPA
more
recently
has
determined,
however,
that:

[
L]
ead
and
lead
compounds
are
highly
persistent
and
highly
bioaccumulative.
The
persistence
of
lead
in
the
environment
is
not
in
question
since,
as
a
metal,
lead
cannot
be
destroyed
in
the
environment.
With
respect
to
whether
lead
or
lead
compounds
released
to
the
environment
will
result
in
lead
that
is
bioavailable,
the
data
indicate
that
under
many
environmental
conditions
lead
does
become
available.

As
a
result,
the
USEPA
now
concludes
that:

[
L]
ead
and
lead
compounds
have
been
shown
to
cause
adverse
effects
at
concentrations
far
less
than
the
de
minimis
levels.
For
example,
EPA
has
stated
that
it
appears
that
some
of
the
health
effects
of
lead,
particularly
changes
in
the
levels
of
certain
blood
enzymes
and
in
aspects
of
children's
neurobehavioral
development,
may
occur
at
blood
lead
levels
so
low
as
to
be
essentially
without
a
threshold.

Based
on
this
new
information,
the
USEPA's
300
ppm
lead
concentration
limit
for
sewage
sludge
is
excessive
and
poses
significant
risks
to
the
children
of
the
farmers,
workers
and
nearby
communities
where
sewage
sludge
is
applied.
As
the
USEPA
itself
acknowledged
in
its
Part
503
risk
assessment,
"
because
childhood
ingestion
of
dirt
is
so
widespread,
and
the
potential
consequences
so
severe,
a
highly
conservative
limit
is
warranted,
especially
in
the
context
of
regulatory
decisions
that
authorize
a
threshold
pollutant
such
as
lead
to
be
added
to
the
environment."
Further,
the
exposure
of
this
erroneous
assumption
in
the
USEPA's
risk
assessment
demonstrates
why
a
thorough
reevaluation
of
the
entire
risk
assessment
process
and
adoption
of
more
conservative
regulations
for
all
regulated
metals
(
and
additional
pollutants
that
a
properly
prepared
risk
assessment
might
identify
and
regulate)
is
warranted.

The
potential
for
adverse
long­
term
impacts
is
the
real
danger
from
sewage
sludge
use
on
agricultural
properties.

The
USEPA
must
acknowledge
and
deal
with
the
very
real
scientific
dispute
regarding
the
safety
of
sewage
sludge
use
on
agricultural
lands,
in
particular,
for
long­
term
effects.
The
main
problem
is
the
lack
of
sufficient
information
about
long­
term
consequences
of
sewage
sludge
use.
As
previously
discussed,
the
USEPA
has
acknowledged
that
it
did
not
have
data
on
long­
term
impacts
of
sewage
sludge
on
crops:

There
are
uncertainties
concerning
the
long­
term
behavior
of
metals
in
sludge.
The
sludge
experts
that
EPA
relied
on
conclude,
based
on
field
studies,
that
iron
oxides
and
manganese
oxides
found
in
sludge
as
a
result
of
wastewater
treatment
and
metal
oxides
naturally
found
in
soils
may
form
complexes
with
the
metals
and
significantly
reduce
their
bioavailability.
Documentation
to
support
USEPA,
2003d
124
these
conclusions
is
limited.
At
a
minimum,
when
the
organic
component
of
the
sludge
breaks
down,
it
is
possible
that
average
concentrations
of
pollutants
may
increase
or
they
may
become
more
bioavailable.

This
concern
is
echoed
by
Dr.
McBride
(
Cornell
University),
in
his
article
entitled
"
Toxic
Metal
Accumulation
from
Agricultural
Use
of
Sludge:
Are
USEPA
Regulations
Protective?",
wherein
he
concurred
that:
"
The
long­
term
consequences
of
the
application
of
metal­
laden
sewage
sludges
at
the
loadings
permitted
by
the
USEPA­
503
regulations
are
still
unknown."

Dr.
McBride
goes
on
to
make
the
following
recommendation:

Most
of
the
agriculturally
productive
soils
in
this
country
are
presently
in
use;
food
production
cannot
simply
be
relocated
if
existing
farm
land
is
degraded.
Our
best
agricultural
soils
need
to
have
their
productivity
and
crop
quality
protected,
not
for
10,
20
or
even
100
yrs,
but
in
perpetuity.
To
this
end,
a
cautious
approach
to
the
application
of
toxic
metals
in
sludges
to
agricultural
soils
would
be
prudent.

Other
scientific
studies
demonstrate
that
long­
term
effects
of
sewage
sludge
use
pursuant
to
Part
503
regulations
are
unknown,
and
that
the
synergistic
effect
of
multiple
metals
together
in
the
soil
has
not
been
considered
by
the
USEPA,
yet
could
be
a
significant
problem.
Even
the
NRC
acknowledged
that:

Following
organic
matter
decomposition,
trace
elements
from
wastewater
and
sludge
are
released
and
form
sparingly
soluble
reaction
products.
.
.
.
Because
of
there
sparingly
soluble
nature
and
their
limited
uptake
by
plants,
they
tend
to
accumulate
in
the
surface
soil
and
become
part
of
the
soil
matrix.
With
repeated
applications
of
wastewater,
and
particularly
sludges,
these
elements
could
accumulate
to
levels
toxic
to
plants
and
soil
organisms.
They
could
also
accumulate
in
crops
where
they
could,
in
turn,
build
up
to
potentially
harmful
levels
in
humans,
domestic
animals,
and
wildlife
that
consume
the
crops.
.
.
.

Concerns
have
been
expressed
about
what
may
happen
once
a
site
has
reached
its
cumulative
limit
for
metals
and
sludge
application
stops.
The
chemical
properties
of
the
soil
will
likely
change
over
time.
The
availability
of
certain
trace
elements
may
increase
and
potentially
cause
phytotoxicity
problems
and/
or
cause
greater
bioaccumulation
of
trace
elements
in
crops.
While
there
is
little
published
information
on
this
long­
term
problem,
the
City
of
Chicago
has
accumulated
soils
and
crop
data
.
.
.
.
Additional
research
is
needed
in
this
area,
but
these
preliminary
results
indicate
that
trace
elements
are
not
necessarily
more
available
for
periods
of
up
to
10
years
following
cessation
of
sludge
applications.

Finally,
the
USEPA
has
been
criticized
for
its
policy
decision
to
lower
the
health
risk
standard
for
sewage
sludge
from
the
originally
proposed
limit
of
1
in
1,000,000
to
1
in
10,000,
a
hundred
fold
decrease
in
the
safety
factor.
The
USEPA
did
not
provide
evidence
to
support
this
policy
change,
except
for
the
bare
assertion
that
a
lower
safety
factor
was
sufficient
because
so
few
people
nationally
are
at
risk
(
although
100%
of
persons
living
and
working
on
sludge
amended
USEPA,
2003d
125
properties,
as
well
as
their
rural
communities
are
at
risk)
and
because
the
higher
standard
might
prevent
some
POTWs
from
land
applying
their
sewage
sludges
(
certainly
not
a
safety
consideration).
For
a
number
of
the
contaminants
the
USEPA
evaluated,
however,
cancer
risk
was
determined
to
be
the
most
significant
risk
from
the
use
of
sewage
sludge.
Therefore,
it
was
this
change
alone
that
resulted
in
the
USEPA
adopting
higher
permissible
levels
of
contaminants
in
sewage
sludge.
As
the
Cornell
Waste
Management
Institute
notes,
a
much
stricter
cancer
risk
value
than
1
in
10,000
is
typically
used
in
setting
regulations
and
in
many
regulatory
contexts
(
e.
g.,
drinking
water
regulation),
a
risk
of
one
excess
cancer
in
1
million
people
exposed
is
used
to
establish
the
standards.

The
bottom
line
is
that
USEPA
may
be
committing
an
egregious
error
in
stating
that
its
assumptions
and
risk
analysis
are
"
conservative."
Not
until
the
USEPA
properly
and
sufficiently
resolves
the
following
concerns
can
the
Part
503
regulations
be
considered
sufficiently
"
conservative"
and
protective
of
the
public
health:
(
1)
additional
contaminants
and
pollutants
should
be
regulated
and,
in
particular,
the
absence
of
data
must
necessitate
the
setting
of
protective
standards
until
more
data
can
be
collected,
not
ignoring
the
risk
entirely;
(
2)
the
risk
assessment
should
be
revised
to
include
the
use
of
higher
cancer
risk
standards
that
are
the
basis
of
existing
air
and
water
quality
standards;
and
(
3)
additional
safety
factors
and
further
studies
are
needed
considering
the
scarcity
of
knowledge
about
the
long­
term
effects
of
using
use
of
sewage
sludge
on
agricultural
lands.

There
is
no
factual
support
or
policy
justification
for
exempting
any
Class
A
Exceptional
Quality
(
EQ)
sewage
sludge
from
regulation.

The
wide­
spread
availability
of
sewage
sludge
for
land
application
purposes
did
not
begin
until
the
USEPA
issued
its
Part
503
regulations
in
1993.
The
classification
of
Class
A
EQ
sewage
sludge
was
not
even
defined
in
the
Part
503
regulations,
but
appeared
later,
in
subsequently
published
guidance
documents.
The
USEPA
provided
very
little
evidence
to
support
its
determination
that
Class
A
EQ
sewage
sludge
should
be
exempt
from
most
of
the
administrative
requirements
and
application
limitations
imposed
on
non­
EQ
sewage
sludge.
The
USEPA
simply
asserts
that
"
EQ
sewage
sludge
is
considered
to
be
comparable
to
other
common
fertilizer
products."
34
CFBF
disagrees
with
this
conclusion.

First,
there
is
a
difference
between
EQ
sewage
sludge
sold
in
small
quantities
in
bags
for
home
and
landscaping
use
and
the
bulk
application
of
sewage
sludge
on
farmland
at
rates
of
20­
40
tons/
acre.
CFBF
takes
no
position
at
this
time
on
the
regulation
of
EQ
sewage
sold
in
bags.
Bulk
use,
however,
raises
significant
concerns.

In
contrast
to
the
USEPA's
assertions
regarding
the
comparability
of
EQ
sewage
sludge
and
commercial
fertilizers,
CFBF
notes
that
for
bulk
use,
the
nutrient
content
of
commercial
fertilizers,
as
opposed
to
sewage
sludge,
is
more
constant
and
less
subject
to
the
inherent
variability
resulting
from
differences
in
treatment
facility
processing.
As
the
USEPA
states:
"[
t]
he
chemical
composition
of
sewage
sludge
may
vary
greatly
between
wastewater
treatment
works
and
also
over
time
at
a
single
plant."
The
National
Academy
of
Sciences
describes
the
problem:
USEPA,
2003d
126
From
the
farmer's
perspective,
other
factors
limit
agriculture
use
of
sewage
sludge.
Sewage
sludge
is
inherently
more
difficult
to
use
than
chemical
fertilizers.
In
part,
this
is
because
the
composition
of
plant
nutrients
and
trace
elements
vary
due
to
differences
among
types
of
sludges
(
e.
g.,
different
water
contents
or
treatment
processes)
and
differences
among
municipalities
and
their
industrial
contributors.
The
composition
of
commercial
fertilizers
are
formulated
to
meet
crop
requirements.

More
troubling
is
that
the
USEPA
believes
EQ
sewage
sludge:

[
C]
an
even
be
applied
to
sites
where
sewage
sludge
that
is
non­
EQ
for
pollutants
has
been
applied
(
even
if
the
site
has
reached
its
maximum
cumulative
pollutant
loading
rate
[
CPLR])
without
having
to
document
compliance
with
any
management
practices.
EQ
sewage
sludge
can
be
transported
to
and
applied
in
States
other
than
where
it
was
prepared
without
any
notification
requirements."

Yet
there
is
very
little
difference
between
Class
A
EQ
sewage
sludge
and
non­
EQ
sewage
sludge.
EQ
and
non­
EQ
sewage
sludges
are
subject
to
the
same
instantaneous
ceiling
concentration
limits
for
heavy
metals.
The
only
difference
between
EQ
and
non­
EQ
sewage
sludges
are
that,
when
calculated
on
a
monthly
average
basis,
the
heavy
metals
content
of
EQ
sewage
sludges
are
limited
to
between
one
third
to
one
half
of
the
heavy
metals
concentrations
allowed
in
non­
EQ
sewage
sludges.
One
exception
is
Nickel,
for
which
EQ
and
non­
EQ
sewage
sludges
have
the
identical
pollutant
limits.
An
obvious
concern
with
relying
on
self­
determined,
infrequently
calculated
averages
is
that
some
loads
of
EQ
sewage
sludge
produced
during
a
particular
month
may
contain
heavy
metals
that
exceed
the
average,
and
may
reach
levels
equivalent
to
non­
EQ
sewage
sludge.

Further,
the
same
heavy
metals
are
present
in
EQ
and
non­
EQ
sewage
sludges
and
these
metals
will
build
up
in
the
soil
with
continued
applications
regardless
of
the
sewage
sludge
classification.
For
this
reason
it
makes
no
sense
to
allow
EQ
sewage
sludge
to
be
applied
at
sites
where
non­
EQ
sewage
sludge
already
has
contaminated
the
property.
Since
one
of
the
basic
premises
of
the
USEPA's
Part
503
regulations
is
that
sewage
sludge
applications
eventually
may
lead
to
harmful
levels
of
heavy
metals
concentrations
in
soil,
and
as
the
same
metals
are
present
in
EQ
as
in
non­
EQ
sewage
sludges,
CFBF
finds
no
rationale
for
waiving
any
regulatory
and
administrative
controls
imposed
on
non­
EQ
sewage
sludge
for
EQ
sewage
sludge.
The
bottom
line
is
that
when
the
when
the
NRC
revisited
this
issue
in
its
updated
2002
study,
it
specifically
found
that
"[
e]
xemptions
from
nutrient
management
and
site
restrictions
for
land
application
of
bulk
EQ
biosolids
should
be
eliminated."

CFBF
believes
the
facts
justify
the
finding
that
the
unregulated
use
of
EQ
sewage
sludge
for
bulk
land
application
purposes
reasonably
will
result
in
adverse
health
effects
and
so
EQ
sewage
sludge
should
not
be
exempt
from
regulation.

Conclusion
The
lack
of
necessary
data,
combined
with
the
USEPA's
acknowledgment
of
unknown
long­
term
effects
demonstrates
that
more
conservative
regulations
are
necessary
in
order
to
protect
the
USEPA,
2003d
127
health
and
safety
of
those
persons
most
directly
effected
by
the
land
application
of
sewage
sludge.
This
requires
the
re­
evaluation
of
the
USEPA's
Part
503
analyses,
assumptions
and
policy
choices
and
unbiased
research
and
examination
of
whether
more
protective
policies
should
be
adopted
for
land
applications
in
rural
areas
on
agricultural
lands.

Response
With
respect
to
the
commenter's
assertion
that
the
Part
503
Standards
may
not
protect
rural/
farm
areas
where
vast
amounts
of
sewage
sludge
are
transported
from
cites
to
be
land
applied
to
farms:
The
Part
503
Standards
are
based
on
modeling
and
protecting
with
an
adequate
margin
of
safety,
the
most
highly
exposed
segments
of
the
U.
S.
population,
farm
families
that
use
sewage
sludge
on
their
farm
land.
With
respect
to
the
other
issues
raised
in
these
comments,
please
see
the
response
to
comments
in
this
section
from
David
Carpenter
in
Comment
Log
No.
43.

EPA
Log
#
50:
Water
Environment
Federation
(
WEF)

Comment
G.
Regulatory
Activities
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
exposure
to
land
applied
biosolids.
A
number
of
associated
recommendations
were
included,
such
as
the
development
of
molybdenum
standards.
Several
additional
risk
management
practices
were
also
recommended.

WEF
supports
the
following
positions
and
initiatives
outlined
by
EPA:

°
EPA
will
review
the
molybdenum
standard
(
to
be
completed
in
2003),
°
EPA
will
evaluate
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
containers
weighing
less
than
one
metric
ton,
°
EPA
believes
the
current
operational
standards
are
appropriate
for
achieving
environmental
performance
while
encouraging
efficient,
cost­
effective,
and
innovative
systems
approaches,
°
EPA
indicates
that
the
additional
practices
recommended
by
the
NRC
are
linked
to
site­
specific
or
local
level
conditions
(
topography,
soil
characteristics
etc.)
and
that
State
and
local
jurisdictions
will
have
better
knowledge
and
are
better
positioned
to
establish
additional
management
practices.

Response
EPA
appreciates
and
agrees
with
these
comments.

PA
Log
#
46:
Association
of
Metropolitan
Sewerage
Agencies
(
AMSA)

Comment
Regulatory
Activities
AMSA
agrees
with
EPA
that
revised
standards
for
molybdenum
should
be
considered.
However,
any
proposed
standards
should
be
based
on
the
most
up­
to­
date
scientific
information
and
a
newly
conducted
risk
assessment.
USEPA,
2003d
128
AMSA
understands
that
the
NRC
is
recommending
that
all
biosolids
products
sold
or
given
away
in
bags
or
other
containers
should
be
exceptional
quality
(
EQ).
AMSA
also
understands
that
by
eliminating
the
non­
EQ
Table
4
alternative,
EPA
would
essentially
prohibit
selling
or
giving
away
biosolids
products
in
bags
or
other
containers
weighing
less
than
one
metric
ton
unless
those
products
met
the
EQ
standard.
Before
making
any
final
regulatory
decision,
AMSA
encourages
EPA
to
confirm
whether
there
are
any
biosolids
products
being
sold
that
conform
to
the
Table
4
alternative
and
to
document
their
justification
for
removing
the
alternative.

Some
AMSA
members
have
expressed
concern
about
the
NRC's
recommendation
that
the
nutrient
management
exemption
be
eliminated.
EPA
never
expressly
addresses
this
recommendation
in
its
response.
Some
AMSA
members
currently
use
this
exemption
and
AMSA
recommends
that
the
Agency
thoroughly
research
and
document
the
need
for
any
regulatory
decision
it
might
make
on
this
issue.
AMSA
agrees
with
EPA
that
states
and
local
jurisdictions
have
a
better
understanding
of
local
conditions
and,
therefore,
are
in
the
best
position
to
establish
additional
management
practices
to
enhance
the
protectiveness
of
the
Part
503
standards
as
needed.

AMSA
endorses
the
NRC
Report's
recommendation
to
study
the
correlation
between
pathogen
destruction
and
indicator
organism
levels
in
biosolids
from
various
treatment
processes,
such
as
anaerobic
and
aerobic
digestion,
and
lime
stabilization.
Studies
of
this
type
will
provide
data
that
will
either
substantiate
the
protective
nature
of
the
Class
A
and
Class
B
pathogen
destruction
criteria,
or
show
there
is
a
need
to
revise
them.

Response
Please
refer
to
the
Summary
Response
in
this
section
of
this
document
and
the
EPA
response
to
comments
received
in
the
Pathogens
Section
of
this
document.
Please
refer
to
previous
responses
on
the
issues
contained
in
these
comments
(
e.
g.
Log
Comment
No.
43­
David
Carpenter
with
respect
to
the
issue
of
the
use
of
sewage
sludge
on
lawns
and
home
gardens).

States
EPA
Log
#
52:
Washington
State
Department
of
Ecology
Comment
Regulatory
Activities.
In
its
summary
EPA
notes
that
the
NRC
recommended
that
all
biosolids
sold
should
be
EQ
products
and
that
bulk
EQ
products
should
not
be
exempt
from
nutrient
management
and
site
restrictions.
This
is
a
significant
recommendation
to
which
EPA
did
not
respond
directly.
I
am
uncertain
as
to
merit
of
the
proposal.
In
Washington
Class
B
biosolids
have
been
purchased
for
nominal
amounts
in
recognition
of
their
fertilizer
value.
Likewise
it
may
not
be
prudent
to
prohibit
the
use
of
EQ
products
(
compost
for
example)
in
certain
sensitive
areas.
On
the
other
hand
there
is
no
good
justification
for
not
requiring
by
rule
(
but
not
strictly
by
permit)
that
bulk
EQ
products
be
applied
at
agronomic
rates
and
follow
other
appropriate
management
practices.
Since
this
recommendation
represents
a
fairly
significant
departure
from
common
management
concepts
it
warrants
further
consideration
by
EPA.
USEPA,
2003d
129
The
NRC
recommended
the
revision
of
the
503
rules
to
eliminate
Table
4
for
annual
pollutant
loading
rates.
EPA
notes
that
virtually
no
material
is
sold
which
exceeds
the
Table
3
pollutant
concentration
limits.
As
a
consequence
EPA
seems
to
question
the
strict
necessity
of
removing
the
table
and
says
it
will
evaluate
data
during
the
coming
year
to
make
a
determination
in
this
matter.

The
presence
of
this
table
in
the
rule
is
at
best
a
nuisance.
Less
now
than
before,
but
we
still
find
ourselves
having
to
explain
the
basis
for
Table
4
(
that
it
is
not
really
a
broadly
applicable
annual
pollutant
loading
rate
limit);
and
then
having
to
defend
the
rule
for
having
what
frankly
seems
to
be
a
pretty
useless
standards.
It
just
adds
to
the
burden
of
public
skepticism.
Nobody
in
their
right
mind
would
attempt
to
market
a
product
with
the
caveat,
"
But
it's
got
a
lot
of
pollutant
X
in
it,
so
only
put
on
this
amount
and
you'll
be
okay."
In
my
opinion,
forget
the
further
evaluation
step
and
propose
to
remove
Table
4.
I
would
not
propose
an
unreasoned
expenditure
of
resources
for
this
singular
purpose,
but
surely
we
can
take
the
simplest
and
most
expedient
route
to
eliminating
Table
4
without
further
debating
the
point.

Response
Please
see
the
EPA
response
to
Comment
Log
No.
43­
David
Carpenter
in
this
section
of
this
document.

EPA
Log
#
45:
Florida
Department
of
Environmental
Protection
Comment
Regulatory
Activities
­
Site
Restrictions:
While
it
may
be
more
appropriate
for
state
and
local
entities
to
adopt
more
stringent
site
management
restrictions
as
indicated
in
the
EPA
response,
Part
503
is
expected
to
contain
adequate,
minimum
standards
for
site
restrictions.
EPA
made
site
management
restrictions
an
integral
part
of
the
strategy
in
Part
503
to
ensure
the
safety
of
Class
B
land
application.
Thus,
after
ten
years
of
implementation
experience
with
Part
503,
it
is
recommended
that
EPA
review
the
adequacy
of
current
site
restrictions
as
well
as
consider
the
recommendations
by
the
NRC
to
evaluate
potential
new
restrictions
for
various
site­
related
factors
such
as
site
slope
and
depth
to
ground
water.

Furthermore,
existing
site
restrictions
and
any
potential
future
ones
should
be
reviewed
by
EPA
with
regard
to
the
ability
to
reasonably
enforce
the
restrictions,
especially
given
the
limited
resources
of
the
EPA
and
state
biosolids
staffs.

Regulatory
Activities
 
Other
Countries
Regulations:
In
addition
to
the
NRC's
recommendation
to
review
other
countries'
regulations,
it
is
recommended
that
EPA
review
various
state
regulations
as
well
as
other
federal
agency
regulations
and
programs
for
different
viewpoints,
perspectives,
and
regulatory
strategies.

Comments
on
Pollutant
Identification/
Regulation
The
EPA
Office
of
Water
should
consider
reviewing
the
Soil
Screening
Guidance
developed
by
the
Office
of
Solid
Waste
and
Emergency
Response
under
the
Superfund
program
for
inconsistencies
with
the
biosolids
program
(
i.
e.
different
standards
for
the
same
pollutant
or
USEPA,
2003d
130
where
the
soil
screening
guidance
calls
for
a
very
restrictive
limit
for
a
pollutant
not
currently
regulated
by
Part
503).
Any
inconsistencies
should
be
documented
and
resolved.

Response
Please
see
the
Summary
Response
to
this
section
and
EPA's
response
to
Comment
Log
No.
8
with
respect
to
site
restrictions
based
on
local
conditions.
Please
see
EPA's
response
to
comments
on
standards
from
other
countries
(
Comment
Log
No.
25).
With
respect
to
new
pollutants
considered
for
regulation
under
Part
503,
please
see
the
EPA
response
to
Comment
Log
Nos
36
and
43­
David
Carpenter.

EPA
Log
#
48
and
39
(
duplicates):
Wisconsin
Department
of
Natural
Resources
Comment
18.
Section
VIII.
G.
Regulatory
Activities
­
New
Standards
­
If
EPA
will
complete
its
review
of
molybdenum
data
in
2003,
will
a
proposed
amendment
to
40
CFR
part
503
follow?
It
is
not
clear
from
this
notice.
Also,
it
is
agreed
that
few
if
any
instances
exist
where
non­
EQ
biosolids
are
sold
or
given
away
in
less
than
one
metric
ton
containers.
That
does
not
preclude
the
need
to
eliminate
the
option
and
the
use
of
Table
4
in
those
instances.
EPA
should
be
able
to
articulate
a
policy
decision
in
this
regard
and
should
do
so.

19.
Section
VIII.
G.
Regulatory
Activities
­
Standardized
Management
Practices
­
The
NAS
report
and
we
agree
with
EPA
that
performance
based
technical
and
operational
standards
are
appropriate
for
pathogen
and
vector
control.
That
is
not
an
issue.
However,
a
major
component
of
the
operational
standard
is
the
assumptions
of
natural
attenuation
in
soil
after
application.
This
must
be
verified
and
it
is
still
not
clear
whether
that
is
part
of
EPA's
plan.
It
should
be
specifically
delineated
(
see
comment
8
above).
It
is
stated
that
the
establishment
of
national
design
criteria
may
not
result
in
the
most
efficient
site
specific
practices
for
protecting
public
health.
In
the
same
paragraph
it
is
stated
that
the
additional
management
practices
recommended
by
the
NRC
are
linked
to
site
specific
or
local
level
conditions.
It
appears
that
EPA
has
confused
two
distinctly
different
recommendations.
The
report
recommendation
for
standard
treatment
plant
design
would
establish
appropriate
detention
times,
temperatures,
aeration,
mixing,
feed
and
withdraw
regimes
etc.
based
upon
pathogen
destruction
across
the
process.
There
would
be
no
local
variation
to
this
other
than
energy
requirements,
etc.
The
study
proposed
in
the
Exposure
section
should
examine
pathogens
in
raw
sludge,
treated
biosolids
and
make
a
correlation
of
destruction
based
on
engineering
principles.
Whether
this
will
be
done
and
the
scope
of
the
study
should
be
better
delineated.
The
report
recommendation
that
EPA
further
consider
management
practices
at
land
application
sites
would
include
slope
restrictions,
setbacks
to
homes,
surface
water,
and
public
and
private
water
supply's,
soil
type
and
characteristics,
etc.
These
likewise
do
not
need
to
be
set
locally.
If
there
are
no
residences
or
surface
waters
nearby
a
flat
field,
then
separation
distances
will
not
be
a
problem.
If
they
are
required
in
the
rule
as
a
minimum
they
will
employ
best
management
practices
to
minimize
runoff
potential,
groundwater
impacts,
and
public
nuisance
issues.
As
EPA
considers
these
site
requirements
they
should
consider
that
experience
shows
that
in
states
that
impose
such
restrictions,
public
complaints
are
minimized.
EPA
should
give
serious
consideration
to
this
recommendation
and
clarify
its
intent.
USEPA,
2003d
131
20.
Section
VIII.
G.
Planned
Regulatory
Activities
­
Studies
­
It
is
stated
that
EPA
is
planning
to
evaluate
certain
Class
B
disinfection
processes
including
anaerobic
digestion
and
lime
addition,
as
well
as
the
natural
attenuation
processes
which
form
the
basis
of
the
Class
B
management
component.
Again,
detail
and
specific
studies
should
be
cited.
Aerobic
digestion
and
other
processes
should
also
be
included.
Again
as
stated
in
comment
8
above
and
elsewhere,
this
is
critical
work
and
should
be
done
on
a
large
enough
and
comprehensive
enough
scale
to
draw
meaningful
conclusions,
as
recommended
in
the
report.

Response
Please
see
the
Summary
Response
to
this
section
of
this
document
with
respect
to
molybdenum
standards.
Please
see
the
EPA
response
to
Comment
Log
Nos.
8
and
25
with
respect
to
the
last
two
paragraphs
of
these
comments
(
site­
specific
conditions
as
a
consideration
in
developing
protective
standards
and
"
National
Design
Criteria").

TOPIC
H.
BIOSOLIDS
MANAGEMENT
Summary
Response:
EPA
considered
this
comment
category
to
include
Part
503
Standards
program
implementation.
Relevant
activities
in
this
category
include
EPA's
Program
for
permits,
oversight,
compliance
assistance,
and
enforcement
of
the
Part
503
Standards.
EPA
also
considered
the
voluntary
Environmental
Management
Systems
(
EMSs)
being
developed
by
the
National
Biosolids
Partnership
(
NBP)
of
which
EPA
is
a
member
organization
to
play
an
integral
role
in
Biosolids
Management.
The
following
describes
EPA
and
NBP
commitments
efforts
in
this
area.
The
reader
is
referred
to
Project
No.
2,
Objective
B
and
Project
No.
14
in
Section
VII
B
of
today's
Federal
Register
Notice
for
a
detailed
discussion
of
EPA's
and
the
NBP's
programs
for
Biosolids
Management,
respectively.
For
convenience,
these
sections
of
today's
Notice
are
extracted
and
given
below.

All
other
comments
under
this
topic,
not
germane
to
EPA's
definition
of
Biosolids
Management,
have
been
responded
to
in
other
comment
categories
in
other
sections
of
this
document.

Project
2:
Compliance
Assistance
and
Enforcement
Actions
As
indicated
in
the
Agency's
preliminary
strategy
of
April
9,
2003
(
see
69
FR
17391)
and
this
final
action
plan,
EPA
will
continue
to
provide
compliance
assistance
to
individuals,
municipalities,
or
other
entities
on
matters
pertaining
to
sewage
sludge
use
and
disposal
and
will
take
enforcement
actions,
as
appropriate.
This
project
relates
to
Category
H,
Biosolids
Management
Activities,
in
the
April
9,
2003
notice.
See
68
FR
17391.

EPA
has
maintained
an
active
presence
in
biosolids
compliance
and
enforcement
activities.
EPA's
enforcement
and
compliance
activities
are
tracked
in
the
Integrated
Compliance
Information
System
(
ICIS)
and
Permit
Compliance
System
(
PCS)
databases.
Specifically,
the
ICIS
database
documents
the
following
Federal
enforcement
actions
taken
to
address
biosolids:
391
administrative
orders
for
FY
1995
­
2002,
119
administrative
penalty
orders
for
FY
1995­
USEPA,
2003d
132
2002,
and
one
civil
judicial
action
in
FY
1997.
The
PCS
database
documents
382
regional
and
state
biosolids
inspections
for
FY
2000
­
2002.

Furthermore,
EPA
Regions
and
States
have
the
responsibility
to
address
situations
where
compliance
assistance
and
enforcement
actions
to
address
biosolids
are
appropriate
and
necessary.
Regional
responsibilities
for
the
biosolids
program
include
actively
following
up
on
phone
calls
and
complaints
received
from
the
public,
and,
where
appropriate
as
demonstrated
by
the
data,
initiating
Agency
enforcement
actions.
EPA
has
taken
enforcement
actions
and/
or
appropriate
administrative
remedies
to
address
biosolids
violations
of
40
CFR
part
503
and
will
continue
to
take
such
actions,
including
instances
where
biosolids
pose
an
imminent
and
substantial
endangerment
to
human
health
or
the
environment.

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.
EPA
is
currently
revising
and
updating
the
manual,
which
is
expected
to
be
complete
in
2004.
The
Clean
Water
Act/
NPDES
Computer
Based
Inspector
Training
CD­
ROM,
including
a
module
specific
to
biosolids
inspections,
was
finalized
in
August
2003.
EPA
plans
to
make
both
of
these
tools
available
on
the
EPA
website.

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
website
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.

EPA
is
also
working
to
improve
its
data
reporting
and
management
system
that
supports
compliance
oversight.
EPA
is
continuing
to
work
with
States
as
it
modernizes
the
Permit
Compliance
System
(
PCS)
to
allow
for
more
effective
program
oversight.
As
part
of
the
PCS
modernization,
a
separate
workgroup
(
including
States
and
EPA)
was
devoted
to
the
data
needed
to
manage
the
biosolids
program.
Based
upon
the
recommendations
of
this
workgroup,
the
PCS
Executive
Council
decided
to
add
data
elements
to
PCS
to
improve
tracking
and
oversight
of
the
biosolids
program,
and
the
draft
detailed
design
was
distributed
for
review.
The
detailed
design
document
was
finalized
in
September
2003,
which
served
as
the
basis
for
the
software
development.
The
anticipated
implementation
date
for
the
modernized
PCS
is
December
2005,
provided
adequate
funding
is
committed
to
this
project.

The
land
application
of
sewage
sludge
in
compliance
with
EPA's
regulations
is
an
appropriate
choice
for
communities.
The
NRC
concluded
that
"
There
is
no
documented
scientific
USEPA,
2003d
133
evidence
that
the
Part
503
rule
has
failed
to
protect
human
health.
However,
additional
scientific
work
is
needed
to
reduce
persistent
uncertainty
about
the
potential
for
adverse
human
health
effects
from
exposure
to
biosolids."
Thus,
EPA
has
directed
its
water
enforcement
and
compliance
resources
to
focus
on
risks
posed
by
wet
weather
issues
and
untreated
pollutants,
including
raw
sewage
and
wastes
associated
with
storm
water,
sanitary
sewer
overflows,
combined
sewer
overflows,
and
concentrated
animal
feeding
operations.
Both
agriculture
and
urban
runoff/
storm
sewers
are
listed
in
the
top
four
sources
of
impaired
river
miles
in
the
2000
National
Water
Quality
Inventory
Report
to
Congress
(
section
305(
b)
report).
Given
the
complexity
and
magnitude
of
addressing
potential
human
exposures
to
pathogens
and
chemicals
from
untreated
human
and
animal
wastes
from
wet
weather
and
the
present
scientific
knowledge
of
the
relative
risks
associated
with
biosolids,
there
is
an
appropriate
level
of
resources
allocated
to
biosolids
compliance
and
enforcement
activities.

Project
14:
Improve
Stakeholder
Involvement
and
Risk
Communication
The
NRC
recommended
that
stakeholders
should
be
involved
in
the
risk
assessment
process
and
to
examine
biosolids
management
practices
to
ensure
that
the
underlying
risk
assessment
principles
are
effectively
translated
into
practice.
As
stated
in
its
preliminary
strategy
in
the
April
9,
2003
notice,
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.
See
68
FR
17386.
EPA
received
many
comments
on
its
preliminary
strategy
of
April
9,
2003,
urging
the
Agency
to
involve
stakeholders
more
widely
in
the
many
aspects
of
the
sewage
sludge
program.

EPA
is
committed
to
working
with
stakeholders
who
are
concerned
with
the
application
or
disposal
of
sewage
sludge
(
the
general
public,
State
and
local
agencies,
and
private
groups).
In
addition,
the
Agency
will
consider
how
it
can
implement
the
NRC's
recommendations
to
involve
stakeholders
in
updating
and
strengthening
the
scientific
credibility
of
the
sewage
sludge
regulations.

The
Agency's
risk
communication
programs
are
aimed
at
improving
public
awareness
of
the
issues
and
achieving
pollutant
exposure
reductions.
Embodied
in
all
of
the
projects
is
not
only
a
need
to
foster
public
awareness
of
the
issues
surrounding
sewage
sludge
use
and
exposure,
but
also
a
recognition
of
the
advances
in
problem­
solving
that
can
be
achieved
through
collaboration
and
cooperation.

Through
the
activities
and
organizations
described
in
this
project,
EPA
will
participate
in
improving
the
effectiveness
of
risk
communication
methods
at
national,
regional,
and
local
levels.
States
have
their
own
oversight
programs,
some
of
which
are
quite
comprehensive.
There
is
a
total
of
about
150
full
time
equivalent
State
employees
assigned
to
their
respective
biosolids
programs.
Five
States
have
been
authorized
by
EPA
to
administer
the
Part
503
program,
and
15
additional
States
are
at
various
stages
in
the
authorization
process.
National
coordination
of
State,
regional
and
Headquarters
biosolids
programs
are
achieved
via
an
annual
State
and
Regional
biosolids
coordinators
meeting.
EPA
plans
to
continue
to
work
closely
with
State
and
USEPA,
2003d
134
Regional
biosolids
coordinators
and
plans
to
support
the
annual
workshop
for
sharing
the
latest
information
about
biosolids
management
and
oversight.
Other
organizations
and
activities
that
are
designed
to
promote
stakeholder
involvement
include
the
following:

An
Information­
Sharing
Group
(
ISG)
has
been
established
based
upon
the
concepts
developed
in
WERF
studies
concerning
joint
fact­
finding
research.
The
ISG
includes
concerned
citizens,
health
scientists,
municipal
operators,
farmer
representation,
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.
WERF
has
efforts
underway
to
expand
the
use
of
such
information­
sharing
in
various
research
projects.

The
National
Biosolids
Partnership
(
NBP)
is
an
alliance
formed
in
1997
with
the
Association
of
Metropolitan
Sewerage
Agencies
(
AMSA),
the
Water
Environment
Federation
(
WEF),
and
EPA.
The
goal
of
the
NBP
is
to
advance
environmentally
sound
and
accepted
sewage
sludge
management
practices
through
partnerships
with
producers,
service
contractors,
users,
regulatory
agencies,
universities,
the
farming
community,
and
environmental
organizations.

The
NBP
is
developing
a
voluntary
Environmental
Management
System
(
EMS)
for
sewage
sludge
to
help
wastewater
agencies
improve
their
sewage
sludge
management
programs
beyond
the
regulatory
minimums.
The
EMS
involves
environmental
improvement,
public
involvement,
and
independent
third
party
review
of
the
facility
applying
for
EMS
status.
Fiftythree
wastewater
agencies
in
the
U.
S.
are
participating
in
this
voluntary
program.
Several
of
these
municipalities
are
ready
or
will
be
ready
for
third­
party
audit
of
their
EMS
programs
in
2004.
Participating
municipalities
report
benefits,
such
as
more
efficient
operation,
reduced
odors
in
sewage
sludge,
less
intrusive
transport
of
the
sewage
sludge
to
land
application
sites,
better
communication,
and
meaningful
involvement
by
the
public.

In
order
for
a
wastewater
facility
to
be
admitted
and
certified
to
the
Partnership
EMS
program,
it
must
meet
five
requirements
established
by
the
NBP:

1.
document
responsibility
for
the
Biosolids
Value
Chain­
pretreatment,
treatment,
and
all
biosolids
management
practices;
2.
commit
to
10
principles
in
the
NBP's
Code
of
Good
Practice;
3.
meet
all
NBP
requirements;
4.
complete
a
fully
independent
third­
party
audit
of
its
EMS
that
has
been
verified
by
a
NBP's
accredited
audit
company;
and
5.
demonstrate
their
commitment
to
continual
improvements
in
their
EMS
for
environmental
performance,
regulatory
compliance,
public
participation,
and
quality
biosolids
management
practices.

Recently,
the
NBP
recognized
the
Orange
County
Sanitation
District
(
OCSD)
in
Fountain
Valley,
California,
as
the
first
wastewater
agency
in
the
Nation
to
be
admitted
to
the
Partnership
EMS
for
biosolids
programs.
The
EMS
certification
signifies
that
OCSD
meets
the
NBP's
USEPA,
2003d
135
requirements
for
the
EMS
program
and
that
it
supports
excellence
in
sewage
sludge
management
practices,
exceeds
regulatory
compliance
obligations,
and
provides
meaningful
opportunities
for
public
participation.

The
NBP
recognized
the
City
of
Los
Angeles
Department
of
Public
Works
as
the
second
wastewater
agency
in
the
Nation
to
be
admitted
to
the
Partnership
EMS
for
sewage
sludge
program.
A
third­
party
audit
of
the
City's
Biosolids
EMS
program
led
to
certification
on
September
4,
2003.
EPA
continues
to
support
the
development
of
EMS
programs
for
wastewater
agencies
and
the
goals
of
improved
communication
and
addressing
public
concerns
in
a
more
timely
manner.

The
NBP
also
announced
release
of
its
2003
Environmental
Management
System
for
Biosolids
"
Self
Help"
Training
Program
intended
to
help
wastewater
agencies
that
are
interested
in
starting
their
own
EMS.
The
Agency
plans
to
continue
supporting
NBP
activities
and
to
work
with
municipalities
to
expand
their
use
of
EMS
and
other
programs
in
biosolids
management.
Two
NBP
websites
present
relevant
sewage
sludge
information:
www.
biosolids.
org
and
http://
biosolids.
policy.
net/
emsguide/
manual/
goodpractmanual.
vtml
.

Academia
EPA
Log
#
51:
Ellen
Z.
Harrison
Comment
EPA
is
not
proposing
additional
management
practice
requirements,
like
setbacks
from
homes.
NRC
recommends
these
be
considered.
Application
of
Class
B
sludges
containing
pathogens
up
to
property
lines
and
thus
proximate
to
places
where
children
play
and
people
spend
time
in
their
yards
is
poor
policy.
Having
witnessed
a
child
playing
on
a
swing
set
behind
their
trailer,
just
feet
from
the
edge
of
a
field
to
which
sludge
was
being
applied,
can
anyone
doubt
that
there
is
the
potential
for
that
child
to
be
exposed
to
the
pathogens
in
the
applied
sludge?
EPA
needs
to
commit
to
establishing
setbacks.

EPA
is
not
proposing
to
require
nutrient
management
or
site
restrictions
for
bulk
applications
of
EQ
sludges
as
recommended
by
NRC.
In
fact
I
find
no
mention
of
this
issue
in
the
EPA
response.
Since
nutrient
contamination
of
waterways
and
groundwater
is
a
concern,
and
since
nutrient
levels
in
Class
A
EQ
sludges
may
be
the
same
as
in
Class
B,
it
makes
no
sense
to
exempt
them
from
such
considerations.

The
EPA
Office
of
the
Inspector
General
first
(
OIG)
twice
investigated
the
EPA
sludge
program
(
USEPA,
2002;
USEPA,
2000).
The
first
report
documents
insufficient
oversight
of
the
sludge
program
by
EPA.
The
agency
clearly
did
not
respond
positively
to
that
report,
since
EPA
staffing
levels
declined
dramatically
in
the
sludge
program
during
the
2
years
between
the
first
and
second
reports.
There
is
clearly
no
EPA
presence
in
most
areas
that
would
ensure
that
even
the
inadequate
503
rules
are
being
complied
with.
EPA
proposes
to
"
continue"
program
implementation
 
which
is
not
responsive
to
the
recommendation
to
enhance
EPA
oversight
and
USEPA,
2003d
136
enforcement.
The
fact
that
sludges
are
being
spread
close
to
where
families
live
and
on
lands
on
which
we
grow
our
food
makes
such
a
stance
indefensible.
A
credible
enforcement
and
compliance
assurance
presence
is
essential.
Voluntary
programs
which
EPA
supports
such
as
the
EMS
system
is
not
a
replacement
for
oversight.

Response
Please
see
the
Summary
Response
to
this
section.

Citizens
EPA
Log
#
8:
David
A.
Burrows
Comment
On
page
17392
of
the
Federal
Register
it
states:
"
Regions
and
States
have
the
flexibility
and
responsibility
to
address
situations
where
compliance
assistance
and
enforcement
actions
to
address
biosolids
are
appropriate
and
necessary."
Local
governments
are
virtually
powerless
to
do
so
in
Pennsylvania
and
the
Pennsylvania
Department
of
Environmental
Protection
clearly
seems
industry
oriented
and
responds
poorly
to
citizens
complaints.

Response
Please
see
the
Summary
Response
to
this
section.

EPA
Log
#
29:
Henry
J.
Staudinger
Comment
H.
EPA's
Biosolids
Management
Strategy
is
Not
Adequate.

NRC
recommends
that
EPA
increase
the
resources
devoted
to
its
biosolids
program;
expand
its
biosolids
management
activities
and
develop
a
procedural
framework
to
implement
human
health
investigations.

EPA
points
to
the
existence
of
an
enforcement
or
compliance
presence
in
each
of
the
EPA
Regional
Offices,
when
EPA
knows
that
those
offices
fail
to
respond
when
complaints
are
made.
EPA's
response
provides
little
assurance
that
better
biosolids
management
will
occur.

IV.
Comments
on
Issues
Specially
Identified
by
EPA
1.
EPA'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.

Unless
and
until
EPA
allocates
sufficient
resources
and
determines
under
what
conditions
biosolids
are
truly
safe,
it
must
take
other
steps
to
afford
minimum
protection
to
those
who
are
forcibly
exposed
to
biosolids,
including
by
way
of
example:

a.
Prohibit
land
application
of
biosolids
where
the
immune
compromised
and
other
sensitive
individuals
may
be
exposed.
USEPA,
2003d
137
b.
Prohibit
land
application
of
biosolids
at
pollution
sensitive
sites
and
during
pollution
sensitive
conditions.

c.
Prohibit
further
land
application
of
biosolids
that
elicit
credible
health
complaints.

d.
Require
full
disclosure
of
constituents
in
biosolids
that
elicit
credible
health
complaints.

e.
Impose
substantial
penalties
when
land­
applied
biosolids
fail
to
meet
Part
503
requirements.
(
This
would
not
only
reduce
public
health
and
environmental
risks,
but
could
serve
as
a
funding
source
for
needed
studies.)

f.
Require
that
all
land
applications
be
limited
to
the
agronomic
rates
for
all
nutrients.
This
will
not
only
reduce
public
health
risks,
it
will
also
reduce
phosphorous
and
nitrogen
pollution
following
biosolids
applications.
(
This
is
especially
important
in
areas
such
as
the
Chesapeake
Bay
Watershed
where
EPA
has
long
been
active
in
attempting
to
reduce
phosphorous
and
nitrogen
pollution.)

g.
Impose
land
application
fees
and
use
the
funds
collected
to
better
monitor,
test
and
enforce
applicable
regulations
as
well
as
to
fund
independent
studies.

h.
Assure
independent
studies
to
address
public
health
and
environmental
concerns.
(
Industry
funded
studies
that
are
not
totally
independent
will
have
the
same
lack
of
credibility
as
the
studies
once
funded
by
the
tobacco
industry
when
that
industry
argued
that
tobacco
products
were
safe.)

Response
Please
see
the
Summary
Response
to
this
section.
EPA
has
committed
the
appropriate
amount
of
personnel
(
FTEs)
and
extramural
dollars
to
implement
the
sewage
sludge
program
described
in
today's
Federal
Register
Notice.

EPA
Log
#
49:
The
Resource
Institute
for
Low
Entropy
Systems
Comment
The
EPA
should
stop
using
federal
money
to
support
the
promotion
of
sewage
sludge
as
a
soil
amendment.
The
EPA
has
given
millions
of
dollars
to
the
sludge
industry's
trade
association,
the
Water
Environment
Federation,
and
the
sludge
industry's
Water
Environment
Research
Foundation.
This
funding
should
stop
and
be
redirected
to
institutions,
organizations,
and
individuals
with
no
financial
stake
in
the
production,
disposal,
or
use
of
sewage
sludge.
If
the
majority
of
an
organization's
membership
has
a
financial
stake
in
sludge
management,
they
should
be
disqualified
from
federal
funding
on
issues
related
to
sludge
research.

Response
EPA
no
longer
"
promotes"
the
land
application
of
sewage
sludge.
Rather
it
is
EPA's
position
that
the
choice
of
a
use
or
disposal
practice
for
sewage
sludge
management
is
the
responsibility
of
local
communities
that
generate
sewage
sludge
as
long
as
the
chosen
practice
meets
all
of
the
appropriate
requirements
of
the
Part
503
Standards
and
complimentary
State
standards
for
the
chosen
sewage
sludge
management
practice.
USEPA,
2003d
138
EPA
Log
#
40:
Thomas
F.
Albert
Comment
Comment
#
37:
On
page
17391
begins
section
"
H.
Biosolids
Management"
in
the
EPA
comments.
This
section
starts
off
with
a
great
summary
of
NRC
recommendations
regarding
biosolids
management
activities.
These
include;
(
1)
strengthen
oversight
program,
(
2)
track
suspected
instances
of
health
impacts,
(
3
)
determine
whether
or
not
Part
503
management
practices
are
working,,
(
4)
implement
health
investigations,
(
5)
determine
whether
treatment
technologies
for
pathogen
control
are
effective,
and
(
6)
determine
whether
chemical
standards
are
met.

Comment
#
38:
On
pages
17391­
17393
EPA
indicates
how
it
will
address
NRC
biosolids
management
recommendations.
This
by
far
the
longest
discussion
by
EPA
as
to
how
it
plans
to
address
certain
NRC
recommendations.
Unfortunely,
even
though
this
section
is
quite
long
(
compared
to
the
others)
it
leaves
much
to
be
desired.
Listed
below
as
items
A­
H
are
specific
comments
pertaining
to
some
points
in
the
section.

A:
EPA
notes
that
it
has
"
an
enforcement
or
compliance
presence
in
each
of
the
EPA
Regional
Offices
for
following
up
on
phone
calls
and
complaints
received
from
the
public,"
EPA
should
explain
what
is
meant
by
"
presence",
how
many
people
would
be
more
helpful.

B:
EPA
notes
that
"
States
have
their
own
oversight
programs,
some
of
which
are
quite
comprehensive."
Judging
from
the
number
of
complaints
that
I
have
heard
from
other
sludge
impacted
people,
most
state
offices
devoted
to
sludge
matters
are
primarily
devoted
to
"
getting
the
sludge
on
the
ground."
My
own
experience
with
PA
Dept.
of
Environmental
Protection
is
that
they
have
very
little
interest
in
helping
sludge
impacted
people,
rather
their
primary
interest
seems
to
be
"
getting
the
sludge
on
the
ground."
If
EPA
has
information
that
state
sludge
offices
do
more
than
"
get
the
sludge
on
the
ground",
it
would
be
very
helpful
for
EPA
to
include
that
in
its
final
version
of
the
comments.

C:
EPA
makes
another
SELF
SERVING
and
MISLEADING
statement
"
EPA
continues
to
meet
its
statutory
obligations
under
the
Clean
Water
Act
(
CWA)
pertaining
to
sewage
sludge."
If
EPA
is
doing
such
a
great
job;
1)
why
does
the
NRC
report
contain
345
pages
and
57
recommendations,
2)
why
did
EPA's
Office
of
Inspector
General
conclude
"
EPA
does
not
have
an
effective
program
for
ensuring
compliance
with
the
land
application
requirements
of
Part
503"
(
see
NRC
report
page
26),
and
3)
why
do
thousands
of
sludge
impacted
people
complain
so
loudly
(
see
NRC
report
page
25)?

D:
When
discussing
EPA
resources
devoted
to
biosolids
and
health
impacts
EPA
notes
"
EPA
will
reconsider
resources
devoted
to
biosolids
if
additional
research
and
science
demonstrate
greater
risk."
Why
does
EPA
use
the
word
"
reconsider"?
It
seems
clear
that
even
if
studies
show
a
greater
health
risk
due
to
sludge,
EPA
will
only
RECONSIDER
increasing
resources
to
reduce
that
risk.
Such
a
statement
only
serves
to
show
that
health
issues
related
to
sludge
are
LOW
PRIORITY
for
EPA.
If
this
is
not
the
case
then
EPA
should
present
a
reasoned
argument
to
the
contrary.
USEPA,
2003d
139
E:
EPA
refers
to
a
study
supported
by
the
Water
Environment
Research
Foundation
(
WERF)
that
"
included
a
survey
on
public
perceptions
and
what
people
know
about
biosolids,
what
their
concerns
are
and
whether
their
concerns
are
being
addressed
adequately."
EPA
surely
knows
(
or
should
know)
that
the
thousands
of
people
fighting
against
Class
B
sludge
are
not
"
happy"
with
Class
B
sludge.
The
NRC
report
(
page
25)
briefly
presents
the
basic
concerns
of
most
sludge
impacted
people;
odors,
various
illnesses
(
headache,
respiratory
and
digestive
disturbances,
eye
irritation,
etc.),
reduced
property
values,
flies,
etc.
EPA
should
also
recognize
that;
1)
nearly
all
people
that
live
near
a
sludge
field
do
not
want
it
near
them,
2)
people
who
"
push
sludge"
(
regulators,
industry
personnel)
do
not
live
near
a
sludge
field,
3)
there
are
numerous
NGOs
whose
members
do
not
want
sludge
near
them,
and
4)
to
my
knowledge
there
are
no
groups
of
people
(
such
as
neighborhoods)
that
are
actively
seeking
to
have
Class
B
sewage
sludge
placed
on
fields
next
to
their
homes
or
their
children's
school.
Does
EPA
know
of
families
that
are
actively
seeking
to
have
Class
B
sewage
sludge
placed
on
neighboring
lands
that
are
adjacent
to
their
homes
or
their
children's
school?

F:
In
the
Science
and
Public
Outreach
subsection
EPA
notes
"
a
need
to
foster
public
awareness
of
the
issues
surrounding
biosolids
use
and
exposure."
EPA
further
notes
that
it
"
is
committed
to
improving
the
effectiveness
of
risk
communication
methods
at
national,
regional,
and
local
levels."
What
are
"
risk
communication
methods"?
Sludge
impacted
people
surely
want
to
know
more
about
the
sludge
near
them
and
the
likely
health
risk.
Ask
sludge
impacted
people,
most
will
likely
state
that
they
have
great
difficulty
in
getting
reliable
information
from
regulators
or
industry
personnel.
Just
try
to
get
information
on
bioaerosols
or
indicators
of
well
contamination
due
to
sludge.
Why
doesn't
EPA
start
helping
people
get
this
information?
Why
is
it
that
people
who
"
push
sludge"
(
regulators,
industry
personnel,
etc.)
do
not
have
their
families
living
next
to
a
sludge
field?

G:
In
the
Science
and
Public
Outreach
subscription
there
is
what
seems
to
be
yet
another
mention
of
the
cooperative
sludge
study
(
EPA/
USDA/
PA
DEP)
in
Pennsylvania.
If
this
study
is
to
be
mentioned
so
often,
WHY
aren't
its
severe
LIMITATIONS
also
mentioned?

H:
The
last
part
of
the
"
how
EPA
will
address
NRC
biosolids
management
recommendations"
section
is
a
subsection
"
Planned
Biosolids
Management
Activities."
This
planned
activities
subsection
is
"
extra
brief,"
only
11
lines.
It
is
VERY
DISAPPOINTING
as
it
just
more
or
less
says
that
EPA
will
try
to
achieve
the
goals
(
short
term
and
long
term)
stated
on
page
17384.
No
specifics
are
given.
Unfortunately,
there
are
no
specifics
as
to
how
EPA
plans
to
address
the
6
points
(
briefly
stated
NRC
recommendations)
listed
above
in
Comment
#
37
and
listed
in
the
3
paragraphs
of
the
section
"
Summary
of
Biosolids
Management
NRC
Recommendations."
Where
are
the
SPECIFICS
as
to
how
EPA
will
address
the
NRC
recommendations?

Comment
#
39:
In
my
opinion
there
is
a
MAJOR
DEFICIENCY
in
the
2
sections
that
pertain
to;
1)
how
EPA
plans
to
address
NRC
Regulatory
Recommendations,
and
2
)
how
EPA
plans
to
address
NRC
Biosolids
Management
Recommendations.
In
neither
of
these
sections,
and
nowhere
in
the
EPA
comments,
is
there
a
clear
plan
to
determine
the
effectiveness
of
SITE
USEPA,
2003d
140
RESTRICTIONS
in
relation
to
Class
B
sewage
sludge.
EPA
apparently
IGNORES
the
2
NRC
recommendations
listed
below
regarding
Class
B
site
restrictions.

NRC
recommendation:
"
Studies
should
be
conducted
to
determine
whether
the
site
restrictions
specified
for
Class
B
biosolids
in
the
Part
503
rule
actually
achieve
their
intended
effect
with
regard
to
pathogen
levels"
(
page
305
NRC
report).

NRC
recommendation:
"
Site
restrictions,
buffer
zones,
and
holding
periods
for
land
applied
Class
B
biosolids
should
consider
geographic
and
site­
specific
conditions
that
affect
pathogen
fate
and
transport"
(
page
304
NRC
report).

When
considering
Class
6
sewage
sludge
applied
to
land,
the
NRC
committee
"
found
that
some
potential
exposure
pathways
were
not
sufficiently
considered
when
the
use
restrictions
were
developed.
For
example,
potential
off­
site
inhalation
of
dust
and
aerosols
does
not
appear
to
have
been
considered"
(
page
304
NRC
report).
The
NRC
committee
also
noted
"
EPA
also
did
not
address
sufficiently
the
potential
for
surface­
water
contamination
by
runoff,
ground
water
contamination,
and
secondary
transmission
of
disease"
(
page
14
NRC
report).
The
NRC
committee
also
noted
"
No
risk
assessments
were
conducted
to
establish
the
1993
pathogen
standards"
for
Class
B
sludge
(
NRC
report
page
13).
EPA
knows
that
most
citizen
sludge
related
complaints
concern
Class
B
sewage
sludge.
People
near
Class
B
sludge
fields
worry
about
health
concerns,
foul
odors,
airborne
spread
of
germs,
contaminated
runoff
onto
adjacent
properties,
drinking
water
(
wells)
contamination,
flies,
declining
property
values,
etc.
Why
doesn't
EPA
propose
a
vigorous
study
program
to
determine
whether
or
not
Class
B
sludge
site
restrictions
are
protective?

Response
Please
see
EPA's
response
through
the
Summary
Response
of
this
section
of
this
document.

EPA
Log
#
25:
Northumberland
Association
for
Progressive
Stewardship
(
NAPS)
Sewage
Sludge
Study
Group
Comment
In
your
docket
paper
you
ask
for
clear
descriptions
of
our
concerns
and
alternatives.
As
you
will
see,
all
we
ask
for
here
is
that
you
implement
the
NRC
recommendations.
The
answers
we
have
received
to
date
from
our
state
and
now
from
your
response
paper,
indicate
that
the
main
issue
is
the
lack
of
state
and
federal
funding
available
for
much
needed
research
and
risk
assessment
strategies.
It
is
the
people
living
in
rural
areas
that
suffer
the
consequences.
It
seems
to
us
that
the
cost
of
necessary
research
should
be
a
cost
of
doing
business
and
should
be
shared
by
the
main
beneficiaries:
municipalities
generating
sludge,
the
sludge
disposal
industry
and
the
farmers
having
the
sludge
land
applied
(
a
solid
minority
of
farmers
and
acreage,
at
least
in
Northumberland
County).
State
and
federal
taxpayers
living
in
rural
communities
should
not
have
their
taxes
used
for
this
purpose,
since
we
already
shoulder
the
financial
burden
of
establishing
and
maintaining
private
septic
sewage
systems.
When
allocated
to
customers
of
the
municipal
sewage
disposal
systems,
we
suggest
that
the
annual
cost
per
customer
would
be
relatively
low.
USEPA,
2003d
141
And
so,
assuming
that
EPA
cannot
dedicate
sufficient
monies
from
your
own
budgets,
we
recommend
that
a
pool
of
funds
from
these
sources
be
the
major
source
of
funding.

Our
second
major
alternative,
in
the
absence
of
sufficient
research
and
risk
assessment
monies,
is
to
have
all
of
the
sewage
sludge
disposed
of
in
state
approved
landfills.
We
are
told
that
about
40%
of
the
sewage
disposed
of
in
Virginia
goes
to
landfills
and
incinerators.
The
local
municipal
sewage
disposal
interests
say
that
the
landfills
are
filling
up,
and
the
sludge
operators
say
it
would
be
too
expensive.
We
say
they
need
to
dig
some
new
land
fills
and,
once
again,
pass
on
the
cost
to
the
main
beneficiaries:
the
municipal
treatment
plants,
the
sewage
disposal
companies
and
the
farmers.
It
would
cost
citizens
of
municipalities
less
than
$
1.00
per
year
each
if
all
sludge
is
land
filled.

Our
third
alternative,
in
the
absence
of
research
funds,
is
to
establish
safety
buffers
and
other
protections
that
will
satisfy
our
concerns
and
most
of
our
allies
in
opposition
to
current
land
application
practices.
EPA
must
ensure
that
unless
and
until
needed
research
is
completed,
that
the
immune
compromised
not
be
exposed
to
sewage
sludge.
Instead
of
100
and
200
feet
for
buffers,
for
example,
require
that
the
edges
of
land
applied
fields
be
at
least
one
mile
from
homes,
shallow
wells,
schools,
churches,
hospitals,
etc.
This
would
then
restrict
land
application
to
fields
well
away
from
residential
homes
and
infrastructure.

Here
are
some
specific
comments
about
the
drafl
EPA
responses:

VII:
EPA's
Strategy
for
Responding
to
the
NRC
Recommendations?
Lines
470­
472.
In
the
discussion
of
current
and
future
EPA
resources,
no
mention
is
made
of
determining
and
requesting
additional
resources,
or
re­
prioritizing
resources
to
implement
the
NRC's
recommendations.
This
is
an
early
indication
that
EPA
is
satisfied
with
the
status
quo.
EPA
must
be
prepared
to
identify
and
apply
additional
resources
if
it
is
to
comply
with
the
Clean
Water
Act.
Buried
back
on
Lines
1110­
1111
is
the
statement,
"
EPA
will
reconsider
resources
devoted
to
biosolids
if
additional
research
and
science
demonstrate
greater
risk."
But
if
EPA
resources
are
not
to
be
allocated
up
front
for
improved
science
and
risk
assessment,
how
will
you
determine
if
there
is
greater
risk?

H.
Biosolids
Management
Lines
1088­
1375.
The
State
of
Virginia,
a
major
importer
of
sewage
sludge,
and
a
Dillon
Rule
State,
has
two
people
on
staff
at
the
Virginia
Health
Department,
to
enforce
regulations
and
monitor
sludge
land
application
throughout
the
State.
This
situation
will
be
improved
somewhat
with
the
local
government
monitors
authorized
by
new
law
passed
last
year.
But
the
monitors
win
be
very
limited
in
the
aspects
they
will
be
allowed
to
test
and
control.
For
example,
because
notification
of
local
residents
is
not
specifically
authorized
by
Department
of
Health
regulation,
the
cost
of
mailing
out
notifications
to
the
local
residents
will
not
be
reimbursable
by
the
State
imposed
user
fee
just
being
implemented.
EPA
regulations
must
address
this
issue
of
restrictions
imposed
on
localities
in
Dillon
Rule
states
as
stated
on
lines
1105­
1107,
"
Regions
and
States
have
the
flexibility
and
responsibility
to
address
situations
where
compliance
assistance
and
enforcement
actions
to
address
biosolids
are
appropriate
and
necessary."
USEPA,
2003d
142
Lines
1252­
1375.
Reference
is
made
to
the
411
pollutants
included
in
EPA's
1988­
1989
analyses.
How
many
hundreds
of
chemicals,
pathogens,
viruses,
pharmaceuticals
and
other
harmful
pollutants
have
been
identified
as
going
through
the
human
waste
stream
since
then?
How
many
new
chemicals
are
going
into
the
sewers?
How
may
combinations
of
all
of
the
above?
The
land
application
of
sewage
sludge
represents
a
vector
of
water
contamination,
especially
for
relatively
insoluble
substances.
The
EPA
has
not
adequately
addressed
this
vector.
This
issue
is
essential
to
the
protection
of
human
health
and
the
environment.

Response
Please
see
EPA's
response
in
the
Summary
Response
to
this
section
of
this
document.

Environmental
Groups
EPA
Log
#
7:
Sierra
Club
Comment
The
NRC
panel
concluded
that
sludge
is
such
a
complex
and
unpredictable
mixture
and
land
application
wrought
with
so
many
variables
and
uncertainties,
that
no
reliable
risk
assessment
is
possible
for
this
activity
(
8)
The
Sierra
Club
therefore
recommends
that
EPA
switch
from
risk
assessment
methodologies
(
19:
17387
et
passim)
to
precautionary
management
strategies
based
on
facts,
not
formulas.

EPA's
reluctance
to
place
additional
restrictions
on
public
exposure
to
sewage
sludges
appears
to
be
primarily,
if
not
solely,
based
on
an
assurance
that
there
are
no
documented
cases
of
illnesses
when
sludge
is
applied
according
to
the
503
Rule.
This
assurance,
however,
is
meaningless
given
the
fact
that
no
system
is
in
place
for
tracking
and
investigating
such
cases.
It
is
also
misleading,
since
numerous
cases
linked
to
sludge
applied
under
the
503
Rule
were
documented
in
the
peer­
reviewed
medical
and
scientific
literature
a
few
days
before
the
NRC
report
was
published
(
6,
7).

EPA
plans
to
strengthen
the
oversight
role
of
its
Pathogens
Equivalency
Committee
(
PEC),
which
evaluates
and
approves
the
efficacy
of
methods
used
in
disinfecting
sewage
sludges
(
19
).
The
PEC,
has
recently
begun
requiring
companies
seeking
approval
for
new
treatment
technologies
to
more
fully
demonstrate
the
efficacy
of
those
technologies
for
reducing
pathogens.
Municipalities
and
private
industry,
however,
are
still
free
to
use
any
of
the
old
technologies
that
were
approved
without
such
testing.

The
end
result
is
that
companies
using
the
current,
untested
technologies
that
gave
rise
to
widespread
adverse
health
complaints
are
given
economic
advantages
over
competitors
wanting
to
market
safer
technologies.
In
short,
the
public
must
wait
for
the
results
of
research
conducted
under
programs
designed
to
promote
current
technologies
as
being
safe
before
EPA
will
consider
whether
it
will
require
any
improvements
in
currently
approved
technologies.
Companies
offering
new,
safer
alternatives,
on
the
other
hand,
must
meet
strict
efficacy
requirements
to
gain
PEC
approval.
This
policy
clearly
serves
the
interests
of
the
major
players
within
private
industry
with
which
EPA
has
developed
a
close
working
relationship,
but
does
not
in
any
way
serve
the
public
interest.
USEPA,
2003d
143
EPA's
position
should
be
that
exposing
populations
near
land
application
sites
to
noxious
air
contaminants
and
allowing
drinking
water
sources
to
become
contaminated
with
sewage
sludge
is
simply
unacceptable.
The
Agency
must
take
immediate
steps
to
remedy
situations
where
this
has
occurred
and
prevent
similar
problems
from
developing
in
other
areas.
Promulgating
more
protective
sludge
management
measures
should
not
be
left
to
local
communities
(
19:
p.
17391)
but
must
be
incorporated
into
the
federal
rules.
Especially
since
a
number
of
communities
whohave
tried
to
put
in
place
more
protective
ordinances,
have
been
sued
or
threatened
with
lawsuits
for
doing
so.(
23).
A
number
of
common
sense
precautionary
management
strategies
that
have
been
developed
by
the
Sierra
Club
(
10)
and
the
Cornell
Waste
Management
Institute
should
be
implemented
immediately,
even
before
they
are
incorporated
in
future
legislation.

Response
Please
see
the
Summary
Response
to
this
section
of
this
document.

EPA
Log
#
43:
Natural
Resources
Defense
Council
(
NRDC)

Comment
REGULATORY
AND
MANAGEMENT
ACTIVITIES
NRC
makes
numerous
recommendations
categorized
by
EPA
as
regulatory
and
management
activities.
These
include
that
EPA:
review
the
literature
pertaining
to
biosolids
from
other
nations;
establish
new
molybdenum
standards;
adopt
national
standard
treatment
design
criteria;
develop
a
quantitative
microbial
risk
assessment
to
establish
regulatory
criteria
for
pathogens;
require
that
all
biosolids
sold
should
be
exceptional
quality
("
EQ
");
and
eliminate
exemptions
for
nutrient
management
and
site
restrictions
for
land
applied
EQ
biosolids.

EPA
does
not
commit
to
implement
any
of
these
recommendations.
It
does
indicate
that
it
plans
to
make
a
determination
in
the
next
year
whether
to
re­
regulate
molybdenum
and
whether
to
ban
sale
of
non­
EQ
sludge,
but
it
does
not
actually
commit
to
setting
any
new
standards,
to
improving
any
management
practices,
to
setting
any
new
national
treatment
design
criteria,
or
changing
any
other
aspect
of
current
sludge
regulation
or
practice.
Indeed,
under
the
heading
"
Planned
Regulatory
Activities,"
EPA's
Response
identifies
only
"
Studies
"
that
it
plans
to
pursue.

Research
alone
is
not
enough.
NRDC
urges
EPA
to
take
action
to
improve
the
safety
of
land
applied
sludge.
That
is
the
key
to
improving
public
acceptance
of
sludge
spreading,
which
is
frequently
identified
by
both
EPA
and
the
sludge
industry
as
a
goal.
NRDC
urges
EPA
to
take
the
NRC
recommendations
to
heart
and
improve
required
management
practices
for
Class
B
sludge
or
ban
it
altogether,
enforce
currently
required
management
practices,
ban
sale
or
distribution
of
non­
EQ
sludge
for
public
or
home
use
(
e.
g.,
playgrounds,
schoolyards,
parks),
and
ban
application
of
sludge
on
land
used
to
grow
food
for
human
consumption
either
directly
or
indirectly
(
from
animals
raised
on
crops
grown
on
sludge).
In
addition,
the
NRC
identified
several
exposure
pathways
that
may
not
be
adequately
protected
under
current
use
restrictions:
groundwater
contamination,
off­
site
inhalation
of
dust
and
aerosols,
and
surface
water
contaminated
by
runoff.
Addressing
these
potential
exposure
pathways
should
be
a
top
priority
for
EPA.
USEPA,
2003d
144
Of
additional
concern
is
the
fact
that
EPA's
biosolids
research
continues
to
lack
any
overarching
evaluative
framework
within
which
such
activities
can
be
planned
and
reviewed.
Simply
leaving
states
and
local
authorities
with
the
responsibility
of
establishing
additional
management
practices
is
likely
to
lead
to
non­
protective
results
in
some
states.
Allowing
those
with
local
knowledge
the
latitude
to
develop
more
effective
management
practices
to
supplement
federal
baseline
standards
could
be
beneficial,
but
without
any
national
strategy
to
evaluate
the
results,
many
of
these
efforts
may
have
very
limited
effect.

NRDC
commends
EPA's
commitment
to
review
the
biosolids
protocols
of
other
nations
but
urges
EPA
not
to
discount
or
dismiss
this
information
merely
because
it
emanates
from
countries
employing
different
approaches
and
legal
frameworks.
Genuinely
considering
different
approaches
to
common
problems
would
allow
EPA
officials
to
effectively
think
outside
the
box
while
re­
evaluating
familiar
policies,
procedures,
and
research
methods.

EPA
declines
to
follow
NRC's
recommendation
to
require
that
biosolids
sold
be
EQ,
basing
its
decision
on
unspecified
information
that
"
virtually
no
biosolids
products
are
sold
or
given
away
in
bags
or
other
containers
"
that
do
not
comply
with
EQ.
If
EPA
were
correct,
then
the
biosolids
industry
should
have
no
objection
to
a
ban
which
would
protect
the
public
from
home
use
and
exposure
to
toxins
and
pathogens
in
sludge.

EPA
also
rejects
NRC's
recommendation
for
the
adoption
of
national
standard
design
criteria,
reasoning
that
"
the
establishment
of
[
such
]
criteria
may
not
application
of
the
most
efficient
site­
specific
practices
for
protecting
public
health."
While
additional
tailoring
of
management
practices
in
accordance
with
local
climate,
geography
or
other
factors
in
order
to
enhance
protections
of
public
health
may
also
be
helpful,
baseline
federal
standards
must
first
be
set
that
are
protective
of
public
health
and
the
environment.

One
of
the
broadest
criticisms
offered
by
NRC
(
as
well
as
by
the
EPA's
own
is
that
EPA
provides
insufficient
support
and
oversight
to
the
program.
In
response,
EPA
contends
that
it
continues
to
meet
its
statutory
obligations
under
the
CWA
pertaining
to
sewage
sludge
and
that
its
allocation
of
resources
is
proportional
to
its
assessment
of
the
risks
posed
to
public
health
and
the
environment
by
biosolids.
Such
conclusory
assertions
beg
the
question:
how
can
EPA
make
this
claim
when
it
is
relying
on
outdated
research
and
regulatory
mechanisms
and
continuing
its
lax
enforcement
of
this
program?

EPA
needs
to
take
an
organizational
step
back
from
the
handful
of
individual
research
projects
it
is
currently
pursuing
and
develop
a
broad
systematic
framework
for
ensuring
that
its
biosolids
program
meets
statutory
requirements.
Such
a
framework
should
incorporate
many
of
the
individual
recommendations
contained
in
the
NRC
Report
into
future
EPA­
supported
biosolids
projects
in
a
cost­
effective
way.
Standardization
of
research
criteria
and
validation
of
methods,
management,
and
treatment
techniques
would
amplify
the
value
of
each
individual
project.
Unrealized
synergies
would
result
from
such
a
coordinated
approach,
enabling
EPA
to
develop
state­
of­
the­
science
regulations
that
would
assuage
public
concerns
about
biosolids
exposure
and
ensure
that
public
health
and
the
environment
are
fully
protected.
USEPA,
2003d
145
Response
With
respect
to
the
last
paragraph
of
these
comments,
EPA
believes
that
the
final
action
plan
of
research
and
the
results
of
the
Section
405(
d)(
2)
C)
screening
project
announced
in
today's
Federal
Register
Notice
can
be
characterized
as
a
broad
systematic
framework
for
ensuring
the
safety
of
the
land
application
of
sewage
sludge
and
that
the
Part
503
Standards
are
meeting
Clean
Water
Act
mandates,
respectively.

Comments
of
Dr.
Peter
L.
deFur
Research,
Monitoring
and
Management
The
NRC
noted
that
the
EPA
503
program
needs
to
incorporate
monitoring
and
research
into
the
current
program
mix.
EPA
should
conduct
monitoring
for
chemical
constituents,
both
inorganic
and
organic,
to
provide
an
enhanced
database
on
which
to
manage
sewage
sludge.
Nationally,
there
is
no
mechanism
or
program
in
place
to
gather
new
data,
and
EPA
should
remedy
this
problem.

The
EPA
list
of
chemicals
in
sludge,
and
the
list
compiled
by
Harrison
(
2003)
both
include
a
number
of
chemicals
for
which
there
are
no
or
insufficient
data
on
toxicity.
This
paucity
of
specific
data
was
one
of
EPA's
reasons
that
chemicals
were
excluded
from
further
consideration
in
the
original
503
rule.
This
problem
exists
in
other
regulatory
areas
for
EPA
­
risk
assessments
are
not
completed
in
the
absence
of
toxicology
data
and
with
absolutely
no
exposure
data
(
though
this
omission
is
more
often
overcome
by
modeling
on
the
basis
of
physico­
chemical
properties
of
chemicals).

EPA
can
take
several
steps
to
remedy
the
paucity
of
toxicological
data:
1)
require
the
data
of
the
manufacturers
under
federal
law;
2)
initiate
a
research
effort
to
obtain
some
of
the
more
critical
data;
3)
change
the
regulatory
approach
to
increase
incentives
for
providing
the
data
and
at
the
same
time
provide
disincentives
to
the
regulated
community
to
continue
with
the
present
lack
of
data;
4)
initiate
a
regulatory
approach
that
makes
default
assumptions
about
unknown
chemicals
to
allow
positive
management
pending
the
completion
of
data­
acquisition.

The
present
503
Rule
deals
with
human
health,
leaving
ecological
risks
to
other
efforts.
Serious
problems
exist
with
POTW
discharges,
as
indicated
by
the
numerous
scientific
papers
on
the
developmental
problems
in
fish
caused
by
sewage
outfalls
(
Jobling
et
al.,
1998).
The
problem
extends
to
other
sorts
of
chemical
contaminations
that
cause
other
problems,
including
salmon
migration
(
Fairchild
et
al.,
1999).
Furthermore,
the
total
amount
of
estrogenically
active
chemicals
must
be
assessed,
as
this
activity
can
alter
biological
function
(
Schultz
et
al.,
2003),
such
as
male
reproduction.

Response
(
to
all
of
the
comments
for
Comment
Log
No.
43)
Please
refer
to
the
Summary
Response
of
this
section
of
this
document.
With
respect
to
comments
in
the
last
paragraph,
Part
503
Standards
extend
only
to
the
sewage
sludge
generated
in
wastewater
treatment
plants
and
not
to
effluent
discharges
from
these
facilities.

Municipal
Wastewater
Treatment
Plants
USEPA,
2003d
146
EPA
Log
#
14:
Metro
Wastewater
Reclamation
District
Comment
The
NRC
report
recommended
that
the
EPA
consider
funding,
supporting,
and
officially
sanctioning
the
Pathogen
Equivalency
Committee
(
PEC)
as
part
of
the
program.
The
Metro
District
does
not
object
to
this
recommendation;
however,
if
implemented
by
EPA,
the
District
recommends
that
membership
on
the
PEC
be
opened
to
include
qualified
scientists
employed
by
private
biosolids
contractors
and
wastewater
treatment
plants.
As
currently
structured,
the
PEC
includes
only
employees
from
EPA
and
the
Centers
for
Disease
Control.
Because
of
this
limitation,
the
PEC
has
not
benefitted
from
the
expertise
that
scientists
from
the
regulated
community
could
bring
to
the
debate
concerning
wastewater
solids
treatment
processes
and
pathogen
equivalency
issues.

The
Metro
District
supports
EPA's
strategy
of
continued
funding
of
relevant
scientific
research
concerning
the
impact
of
biosolids
on
human
health
and
the
environment.
As
part
of
this
effort,
the
District
recommends
that
EPA
consider
funding
studies
conducted
by
private
biosolids
applicators
or
wastewater
treatment
agencies.
These
entities
may
be
able
to
develop
data
useful
to
EPA's
long­
term
goals
of
understanding
the
benefits
and
potential
consequences
of
biosolids
land
application
and
determining
whether
existing
Part
503
site
management
restrictions
are
effective.

The
NRC
report
recommended
that
EPA
devote
additional
human
resources
to
management
and
oversight
of
the
federal
biosolids
program..
EPA's
response
to
this
recommendation
was
to
indicate
that
additional
staff
has
been
assigned
to
the
federal
program..
EPA
also
noted
that
individual
states
have
staff
assigned
to
the
management
of
approved
programs.
The
Metro
District
believes
that,
whenever
feasible,
state
oversight
of
individual
biosolids
programs
is
the
best
regulatory
option.
The
District
recommends
that,
in
addition
to
devoting
additional
staff
to
the
federal
program,
EPA
consider
contributing
additional
funding
to
states
to
implement
their
own
programs.
EPA
should
take
steps
to
remove
roadblocks
that
hinder
or
prevent
states
from
receiving
approval
authority
to
administer
such
programs.
State
run
biosolids
programs
can
improve
biosolids
management
practices
by
providing
more
local
technical
support
and
reducing
compliance
activities
associated
with
multiple
permitting
and
regulatory
requirements.
For
example,
the
District
­
as
a
biosolids
producer
and
land
applier
in
a
non­
delegated
state
­
must
comply
with
the
requirements
of:
(
1)
the
federal
503
regulations,
(
2)
the
Colorado
Biosolids
Regulation
(
5
CCR
1002­
64),
(
3)
the
District's
discharge
permit
(
which
includes
specific
biosolids
management
requirements),
(
4)
the
EPA
Region
Vlll
Biosolids
General
Permit,
and
(
5)
various
local
government
regulations.

In
addition,
states
with
approved
and
funded
biosolids
programs
likely
would
be
in
a
better
position
to
address
other
management
issues
raised
by
the
NRC
report,
such
as
expanding
and
strengthening
oversight
programs,
tracking
allegations
of
possible
exposure­
related
health
effects,
and
conducting
studies
to
determine
how
well
the
management
practices
specified
in
40
CFR
Part
503
achieve
their
intended
goals.
The
Metro
District
supports
such
expanded
roles
for
state
run
programs.
USEPA,
2003d
147
Response
EPA
generally
agrees
with
these
comments.

EPA
Log
#
19:
Metropolitan
Water
Reclamation
District
of
Greater
Chicago
Comment
We
have
several
research
projects
that
are
under
development,
undergoing
start­
up,
in
progress,
or
that
are
recently
completed
that
will
generate,
are
generating,
or
have
generated
scientific
data
and
information
that
the
EPA
may
find
useful
over
the
next
few
years
as
they
reevaluate
exposure
and
risk
assessment.
These
projects
are:

a.
The
Trace
Element
Toxicity
Study
in
which
phytotoxic
thresholds
were
determined
for
nickel
and
zinc
for
various
turf
grasses
and
crops.
b.
The
USX
South
Works
Slag
Reclamation
Project
in
which
the
leaching
of
metals,
and
inorganics
and
organic
priority
pollutants
from
biosolids
has
been
studied
under
worst
case
conditions.
c.
The
molybdenum
leaching
study
which
is
being
designed
and
will
be
contracted
out
shortly.
d.
Pathogen
exposure
assessment
at
land
application
sites.

Response
EPA
appreciates
the
offer
to
share
this
data.
As
stated
previously,
a
key
feature
of
EPA's
sewage
sludge
program
is
an
active
outreach
and
cooperative
effort
with
all
sewage
sludge
Stakeholders.

EPA
Log
#
24:
Hampton
Roads
Sanitation
District
(
HRSD)

Comment
As
a
generator
of
biosolids,
HRSD
appreciates
the
undue
pressure
that
has
been
placed
on
EPA
with
regards
to
biosolids
land
application.
We
have
experienced
firsthand
the
public
resentment
to
an
ecologically
appropriate
program.
Additional
biosolids
regulations
have
been
promulgated
in
our
State
in
response
to
public
emotion
rather
than
the
introduction
of
new
scientific
information.
HRSD
believes
this
to
be
a
disturbing
precedent
and
would
like
to
see
EPA
take
the
lead
in
stopping
this
trend.
It
can
only
be
accomplished
by
EPA
actively
seeking
quality
data
and
initiating
valid
exposure­
assessment
studies.
Exhibiting
a
strong
presence
in
the
oversight
of
biosolids
management
will
go
a
long
way
in
restoring
public
confidence.
Any
new
regulations
should
be
the
result
of
peer
reviewed
information
and
not
an
attempt
to
quiet
false
claims
of
public
endangerment.

Response
EPA
appreciates
and
agrees
with
these
comments.
Today's
Federal
Register
Notice
demonstrates
that
EPA
will
continue
to
lead
the
National
effort
in
the
maintenance
and
improvement
of
an
environmentally
sound
and
cost
effective
sewage
sludge
management
program.

Unknown
EPA
Log
#
34:
Anonymous
USEPA,
2003d
148
Comment
Also
at
issue
is
the
EPA's
extreme
limitations
placed
on
the
NRC
in
terms
of
the
scope
of
allowable
recommendations.
Many
elements
of
biosolids
management
were
outside
of
the
NRC
scope,
fortunately
the
NRC
presented
the
concerns
it
the
report
.
It
appears
that
the
EPA
is
using
the
NRC's
scope
of
study
as
a
basis
to
avoid
a
wide
number
of
recommendations.
Some
specific
examples
are
:
"
EPA
would
be
well
advised
to
include
more
specific
site
requirements
in
its
biosolids
regulations,
including
minimum
depth
to
groundwater,
controls
on
winter
application,
and
setback
distances
from
residences"
(
p.
89)
and
"
the
major
problem
discussed
at
the
work
shop
was
the
Class
A
process
criteria
that
do
not
take
into
account
potentials
for
regrowth"
(
p.
79).
"
EPA
has
not
acted
to
revise
the
molybdenum
standard"
(
p.
50)
and
"
radioactive
contaminants
were
not
included
in
the
committee's
assessment,
even
though
the
committee
is
aware
that
radioactive
compounds
may
be
present
in
biosolids"
(
p.
28).

Another
major
issue
is
that
the
EPA
response
is
only
focused
on
human
health.
Noting
page
28
of
the
NRC
report
the
EPA
issued
the
requirement:
"
the
committee
was
asked
to
focus
its
evaluation
on
human
health
risks
and
not
on
plant,
animal
or
ecological
risks"
This
is
despite
the
mandate
by
the
CWA
to
set
standards
"
adequate
to
protect
public
health
and
the
environment
from
reasonably
anticipated
adverse
effect
of
each
pollutant"
(
emphasis
added).
Issues
raised
in
the
NRC
report
pertaining
to
lack
of
enforcement,
review,
and
impacts
to
surface
water
and
ground
water
are
not
addressed
by
the
EPA
in
the
response.

Response
EPA
has
considered
all
of
the
NRC
recommendations.
The
final
action
plan
described
in
today's
Federal
Register
Notice
responds
to
the
most
critical
recommendations
of
the
NRC
and
is
designed
to
augment
protection
of
public
health
from
the
land
application
of
sewage
sludge
in
an
expeditious
manner.
Radioactive
contamination
as
well
as
ecological
effects
from
sewage
sludge
land
application
were
not
addressed
by
NRC
although
NRC
was
not
constrained
from
considering
and
providing
recommendations
on
the
former.
The
issue
of
radionuclides
in
sewage
sludge
and
their
potential
threat
to
human
health
is
being
addressed
by
a
separate
Inter­
Agency
effort.
A
Federal
Register
Notice
announcing
this
will
be
published
by
the
end
of
Calendar
2003.

EPA
did
perform
a
screening
ecological
risk
analysis
(
SERA)
on
dioxins
in
sewage
sludge
(
Federal
Register
Notice
of
October
24,
2003).
The
results
of
this
activity
indicated
that
the
presence
of
dioxins,
which
are
highly
toxic,
environmentally
persistent
and
bioaccumulative
in
land
applied
sewage
sludge,
did
not
result
in
a
significant
threat
to
ecological
species.
In
addition,
EPA
applied
the
same
ecological
screening,
which
was
applied
to
dioxins,
to
the
chemicals
which
were
screened,
as
described
in
today's
notice.
In
the
future,
when
a
more
robust
ecological
risk
assessment
methodology
for
land
application
of
pollutants
is
available,
EPA
would
expect
to
consider
ecological
impacts
from
these
other
pollutants
in
land
applied
sewage
sludge
in
future
Part
503
Rule
amendments.

Land
Application
Company
EPA
Log
#
26:
Synagro
Technologies,
Inc.
USEPA,
2003d
149
Comment
The
NAS/
NRC
report
made
specific
recommendations
regarding
EPA's
management
of
biosolids
programs.
EPA
has
responded
to
these
recommendations
in
a
positive
manner.

°
Significance
of
NBP
and
other
consensus
organizations
needs
to
be
maintained.
°
State
and
local
regulatory
and
public
health
agencies
should
remain
first
points
of
contact
and
regulation
for
biosolids.

Response
EPA
agrees
with
these
comments.

Associations
EPA
Log
#
30:
Tri­
TAC
Comment
EPA's
Response
to
the
NRC
Report
makes
it
clear
that
the
NRC's
overall
finding
that
"
there
is
no
documented
scientific
evidence
to
indicate
that
the
part
503
rule
has
failed
to
protect
human
health,"
but
that
additional
scientific
work
is
needed
to
reduce
persistent
"
uncertainty"
about
the
potential
for
adverse
human
health
effects
from
exposure
to
biosolids,
will
be
a
guiding
principle
for
EPA
as
its
plans
the
future
of
its
biosolids
regulatory
program.
Acknowledging
the
limits
of
EPA's
finite
budget,
and
given
the
numerous
recommendations
made
by
the
NRC,
Tri­
TAC
recommends
that
the
EPA
maximize
its
limited
resources
by
targeting
those
areas
that
will
directly
address
the
public's
persistent
uncertainty
and
improve
public
confidence
in
the
practice
of
land
applying
biosolids.

Tri­
TAC
supports
the
EPA's
initial
strategy
for
responding
to
the
NRC's
recommendations.
EPA
has
outlined
three
main
objectives
for
attaining
a
better
understanding
of
biosolids
reuse
and
reducing
the
potential
for,
and
uncertainty
related
to,
human
health
impacts:

°
Update
the
scientific
basis
of
Part
503
by
conducting
research
in
priority
areas;
°
strengthen
the
biosolids
program
by
evaluating
results
of
completed,
ongoing,
or
planned
studies
both
within
and
outside
EPA;
and
°
to
continue
ongoing
activities
for
enhancing
communication
with
outside
associations
and
with
the
public.

These
objectives
largely
mirror
what
Tri­
TAC
contends
that
must
be
the
EPA's
priorities
for
strengthening
its
regulatory
program
for
biosolids
management.

Enhanced
Communication
EPA's
third
objective,
to
continue
ongoing
activities
for
enhancing
communication
with
outside
associations
and
the
public,
is
by
far
the
most
critical
for
enhancing
the
broad
understanding
and
public
acceptance
of
the
biosolids
program.
EPA's
continued
support
of
the
National
Biosolids
Partnership's
voluntary
Environmental
Management
System
program
is
certainly
a
key
component
of
this
enhanced
communication,
but
the
EPA's
efforts
must
go
further
to
ensure
the
public
has
confidence
in
the
practice
of
land
application.
USEPA,
2003d
150
Ensuring
Public
Awareness
of
EPA's
Regulatory
Program
It
has
grown
increasingly
clear
to
Tri­
TAC
that
the
public,
especially
in
California,
as
well
as
local
elected
and
appointed
officials,
are
not
sufficiently
aware
of
EPA's
comprehensive
regulations
regarding
the
land­
application
of
biosolids
and,
as
such,
are
more
susceptible
to
determining
that
biosolids
are
not
beneficial.
Local
hearings
in
California
and
in
Arizona
on
whether
to
prohibit
the
land­
application
of
biosolids
have
increased
and
it
is
critical
that
these
local
decision­
makers
hear
from
EPA
that
the
Part
503
biosolids
regulatory
program
ensures
that
land
application
is
performed
soundly
and
safely.
Tri­
TAC
recommends
that
EPA
designate
a
specific
staff
position
to
voice
EPA's
perspective
at
such
hearings
and,
more
generally,
to
ensure
that
the
Part
503
program's
safeguards
are
broadly
understood.
This
is
a
task
that
simply
cannot
be
performed
by
other
stakeholders
and
would
go
far
toward
guaranteeing
that
decisions
regarding
the
land
application
of
biosolids
are
made
not
on
the
basis
of
emotional
and
potentially
misleading
accounts,
but
on
a
full
understanding
of
the
safeguards
currently
in
place.
Should
EPA
not
have
the
resources
to
hire
someone
new
for
such
a
position,
EPA
should
make
every
effort
to
use
its
current
staff
at
both
Headquarters
and/
or
in
the
Regions
to
testify
at
these
hearings
and
ensure
that
the
EPA's
perspective
is
voiced.

Biosolids
Management
The
NRC
Report
recommended
that
EPA
devote
additional
human
resources
to
management
and
oversight
of
the
federal
biosolids
program.
Tri­
TAC
understands
that
EPA
bases
its
allocation
of
resources
to
its
biosolids
compliance
and
enforcement
program
on
its
assessment
of
the
risks
to
public
health
and
the
environment
posed
by
biosolids
and
understands
that,
given
the
low
assessed
risk,
the
biosolids
program
has
not
been
identified
as
a
high
priority
area
for
Agency
resources.
Nevertheless,
as
mentioned
above
in
the
General
Comments
section
of
this
letter,
Tri­
TAC
believes
that
some
additional
funding
for
staff
at
the
national
level
is
warranted
to
improve
communication
with
the
public
on
the
Part
503
program
and
the
safeguards
it
provides.

As
EPA
collects
new
information
with
regard
to
implementing
the
NRC's
recommendations,
EPA
should
continue
to
evaluate
whether
the
resources
currently
committed
to
the
biosolids
program
are
adequate.
Tri­
TAC's
welcomes
any
increase
in
resources,
at
the
federal
or
state
level,
deemed
necessary
by
the
NRC
or
EPA
to
strengthen
this
critical
program.

Tri­
TAC
does
not
believe
that
the
responsibility
for
making
additional
resource
commitments
rests
solely
with
EPA.
States,
including
California,
also
need
to
make
commitments,
especially
in
the
areas
of
compliance
assistance
and
enforcement.
These
types
of
investments
will
no
doubt
be
challenging
given
the
current
economic
condition
of
many
state
budgets,
but
such
resource
commitments
will
prove
to
be
more
than
cost
effective
in
the
future.
EPA
should
consider
contributing
additional
funding
to
states
to
implement
their
own
programs
and
take
steps
to
remove
roadblocks
that
hinder
or
prevent
states
from
receiving
approval
authority
to
administer
such
programs.
State
run
biosolids
programs
can
improve
biosolids
management
practices
by
providing
more
local
technical
support
and
reducing
compliance
activities
associated
with
multiple
permitting
and
regulatory
requirements.
USEPA,
2003d
151
Response
EPA
is
in
general
agreement
with
these
comments
as
reflected
in
the
final
action
plan
described
in
today's
Federal
Notice.

EPA
Log
#
27:
California
Farm
Bureau
Federation
Comment
The
ISG's
supposed
"
large
cooperative
study"
is
limited
and
does
not
respond
to
the
NRC's
recommendations.

The
notice,
at
68
FR
17392,
refers
to
an
Information
Sharing
Group
(
ISG),
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."
In
reality,
the
study
is
limited
to
five
very
small
application
sites
with:

Scarce
or
nonexistent
historical
records
or
data
as
to
the
constituents
that
are
in
the
biosolids
and
whether
they
have
ever
elicited
health
effects.
Not
all
chemicals
are
being
analyzed
in
emissions,
and
therefore
all
chemicals
that
could
potentially
be
emitted
during
land
application
will
not
be
known.
Furthermore,
these
are
case
studies
and
may
have
limited
value
for
predicting
outcomes
related
to
emissions,
exposure,
odor
and
irritation
at
other
sites
that
utilize
biosolids.

Moreover,
this
study
is
not
a
health
effects
study
and
thus
"
does
not
address
those
NRC
recommendations."
Therefore,
the
USEPA
should
not
rely
on
the
ISG
and
the
referenced
study
for
conclusive
health
effects
data
or
as
a
valid
response
to
NRC
concerns.

Further
research
must
be
conducted
by
neutral
entities
with
no
economic
interest
in
the
results.

The
public
is
skeptical
of
research
activities
that
are
funded
and/
or
performed
by
entities
that
have
a
vested
interest,
primarily
economic,
in
the
continuation
and
expansion
of
biosolids
land
applications
and
that,
at
the
same
time,
oppose
any
limitations
to
their
activities.
It
is
not
apparent
that
completely
unbiased
research
can
ever
be
conducted
by
such
entities,
due
to
their
inherent
conflicts
of
interest.
In
order
to
restore
public
faith
in
the
investigatory
and
regulatory
duties
of
the
USEPA,
the
USEPA
must
not
play
the
role
of
both
regulator
and
promoter
of
biosolids.
USEPA
biosolids
research
funds
should
be
directed
to
neutral
research
bodies
that
have
no
predetermined
expectations
or
economic
interests
in
the
results.
Only
in
this
fashion
will
the
public
gain
confidence
in
the
USEPA's
processes
and
better
accept
the
associated
risk
assessments
and
regulations
governing
biosolids
use
in
this
country.

Response
See
the
Summary
Response
in
this
section
of
this
document.
EPA
in
previous
sections
of
this
document
has
responded
to
the
issue
of
"
tainting
of
information"
received
from
stakeholders
associated
with
the
wastewater
treatment
industry.
All
data
from
all
stakeholders
will
be
considered
and
evaluated
by
EPA
against
the
standards
of
EPA's
Data
Quality
Guidelines.
As
stated
before,
EPA
no
longer
"
promotes"
the
land
application
of
sewage
sludge.
Rather
it
is
EPA's
position
that
the
choice
of
a
use
or
disposal
practice
for
sewage
sludge
management
is
the
responsibility
of
local
communities
that
generate
sewage
sludge
as
long
as
the
chosen
practice
USEPA,
2003d
152
meets
all
of
the
appropriate
requirements
of
the
Part
503
Standards
and
complimentary
State
standards
for
the
chosen
sewage
sludge
management
practice.

EPA
Log
#
50:
Water
Environment
Federation
(
WEF)

Comment
Cooperation,
Collaboration
and
Inclusion
 
The
proposed
strategy
emphasizes
teaming
with
other
agencies,
which
should
improve
perceived
credibility
and
optimize
the
use
of
USEPA
resources,
and
the
inclusion
of
stakeholders.
The
Pennsylvania
study,
which
was
referenced
several
times
in
the
report,
is
a
model
of
this
cooperative,
inclusive
approach
and
should
serve
as
a
model
for
other
initiatives
noted
in
this
strategy.

The
strategy
identifies
proposed
short­
term
and
long­
term
priority
actions.
Under
item
4
of
the
long­
term
goals,
EPA
indicates
that
its
approach
includes
"
promoting
policy
and
procedural
guidance
for
ensuring
and
maximizing
the
quality
of
information
disseminated".
WEF
recommends
that
this
be
included
as
a
short­
term
goal
to
make
sure
that
information
disseminated
by
EPA
adheres
to
a
basic
standard
of
quality.
EPA
also
included
"
review
available
data,
track
ongoing
studies
by
researchers
outside
of
EPA,
and
identify
information"
as
short­
term
actions.
WEF
is
available
as
an
information
resource
to
assist
EPA
in
this
task
and
is
willing
to
provide
any
applicable
WEF
data
or
information.

In
the
case
of
biosolids,
EPA
has
not
been
effective
in
coordinating
and
reviewing
the
data
that
is
routinely
submitted
by
Publicly
Owned
Treatment
Works
(
POTWs)
and
other
affected
parties
to
the
regions.
WEF
believes
that
this
data
needs
to
be
coordinated
better
by
EPA
in
order
to
base
any
of
its
enforcement
actions
and
priorities.
EPA
should
allow
electronic
submission
of
biosolids
quality
data
from
POTWs
and
other
affected
parties.
Electronic
submission
of
biosolids
data
would
alleviate
the
need
for
regional
staff
to
reenter
this
data,
maintain
accuracy
by
the
submitter,
and
allow
EPA
to
compile,
analyze,
and
document
this
information
in
a
timely
fashion.
Electronic
submission
of
data
would
also
facilitate
continued
and
increased
usage
of
an
existing
data
management
tool,
the
Biosolids
Data
Management
System
(
BDMS),
and
help
make
it
into
a
more
complete
database.

H.
Biosolids
Management
WEF
supports
the
use
of
multiple
approaches
and
groups
proposed
by
EPA
to
insure
that
POTWs
have
the
tools
available
to
promote
and
go
beyond
compliance
with
biosolids
regulations.
WEF
also
agrees
with
the
NRC
recommendation
that
EPA
increase
its
resources
devoted
to
the
biosolids
program
and
expand
biosolids
program
activities.

The
commitment
to
improved
risk
communication
as
EPA
embarks
on
the
ambitious
program
set
forth
in
this
strategy
is
also
encouraged,
since
a
lack
of
understanding
regarding
the
actual
risks
associated
with
biosolids
use
remains
a
key
obstacle
to
its
acceptance.
EPA
must
improve
its
ability
to
communicate
with
the
general
public,
elected
officials,
and
other
key
groups.
WEF
believes
that
these
groups
must
be
better
informed
about
improved
biosolids
quality
and
know
where
and
how
biosolids
are
being
recycled
and
overseen.
EPA
needs
to
inform
stakeholders
of
the
real
causes
of
alleged
problems
from
the
use
of
biosolids
and
to
inform
these
groups
of
the
USEPA,
2003d
153
benefits
of
recycling
biosolids
and
other
by­
products,
especially
in
relation
to
manures
and
chemical
fertilizers,
both
of
which
are
used
in
far
greater
quantities
than
biosolids.

EPA
should
continue
its
support
for
the
Environmental
Management
System
for
biosolids
under
development
by
the
National
Biosolids
Partnership.
The
NBP
has
been
aggressively
promoting
excellence
in
biosolids
management
practices
from
within
the
biosolids
community
through
the
development
of
the
EMS.
The
EMS
is
a
creative
and
progressive
program
intended
to
help
assure
compliance
and
go
beyond
regulatory
compliance,
serve
as
a
tool
to
enhance
facility
performance,
and
address
concerns
in
local
communities
such
as
odors
and
noise.
WEF
believes
that
the
NBP's
EMS
program
will
also
allow
regulatory
agencies
to
better
target
their
enforcement
and
compliance
efforts.

Response
EPA
is
in
general
agreement
with
these
comments.

EPA
Log
#
46:
Association
of
Metropolitan
Sewerage
Agencies
(
AMSA)

Comment
Enhanced
Communication
EPA's
third
objective,
to
continue
ongoing
activities
for
enhancing
communication
with
outside
associations
and
the
public,
is
by
far
the
most
critical
for
enhancing
the
broad
understanding
and
acceptance
of
the
biosolids
program.
EPA's
continued
support
of
the
National
Biosolids
Partnership's
Environmental
Management
System
program
is
certainly
a
key
component
of
this
enhanced
communication,
but
the
Agency's
efforts
must
go
further
to
ensure
the
public
has
confidence
in
the
Part
503
program
and
the
practice
of
land
application.

Ensuring
Public
Awareness
of
EPA's
Regulatory
Program
It
has
grown
increasingly
clear
to
AMSA
that
the
public,
both
at
the
local
and
national
levels,
as
well
as
local
elected
and
appointed
officials,
are
not
sufficiently
aware
of
EPA's
comprehensive
regulations
regarding
the
land­
application
of
biosolids
and,
as
such,
are
more
susceptible
to
determining
that
biosolids
are
not
beneficial.
Local
hearings
around
the
country
on
whether
to
prohibit
the
land­
application
of
biosolids
have
increased
and
it
is
critical
that
these
local
decision­
makers
hear
from
EPA
that
the
Part
503
biosolids
regulatory
program
ensures
that
land
application
is
performed
soundly
and
safely.
AMSA
recommends
that
EPA
designate
a
specific
staff
position
to
voice
EPA's
perspective
at
such
hearings
and,
more
generally,
to
ensure
that
the
Part
503
program's
safeguards
are
broadly
understood.
This
is
a
task
that
simply
cannot
be
performed
by
other
stakeholders
and
would
go
far
toward
guaranteeing
that
decisions
regarding
the
land
application
of
biosolids
are
made
not
on
the
basis
of
emotional
and
potentially
misleading
accounts,
but
on
a
full
understanding
of
the
safeguards
currently
in
place.
Should
EPA
not
have
the
resources
to
hire
someone
new
for
such
a
position,
the
Agency
should
make
every
effort
to
use
its
current
staff
at
both
Headquarters
and/
or
in
the
Regions
to
testify
at
these
hearings
and
ensure
that
the
Agency's
perspective
is
voiced.

Biosolids
Management
The
NRC
Report
recommended
that
EPA
devote
additional
human
resources
to
management
and
oversight
of
the
federal
biosolids
program.
AMSA
understands
that
EPA
bases
its
allocation
of
USEPA,
2003d
154
resources
to
its
biosolids
compliance
and
enforcement
program
on
its
assessment
of
the
risks
to
public
health
and
the
environment
posed
by
biosolids
and
understands
that,
given
the
low
assessed
risk,
the
biosolids
program
has
not
been
identified
as
a
high
priority
area
for
Agency
resources.
Nevertheless,
as
mentioned
above
in
the
General
Comments
section,
AMSA
believes
that
some
additional
funding
for
staff
at
the
national
level
is
warranted
to
improve
communication
with
the
public
on
the
Part
503
program
and
the
safeguards
it
provides.

As
EPA
collects
new
information
with
regard
to
implementing
the
NRC's
recommendations,
the
Agency
should
continue
to
evaluate
whether
the
resources
currently
committed
to
the
biosolids
program
are
adequate.
As
stated
in
our
January
30,
2003
letter,
AMSA's
members
are
top
performers
in
the
industry
and
would
welcome
any
increase
in
resources,
at
the
federal
or
state
level,
deemed
necessary
by
the
NRC
or
EPA
to
strengthen
this
critical
program.

AMSA
does
not
believe
that
the
responsibility
for
making
additional
resource
commitments
rests
solely
with
EPA.
States
also
need
to
make
commitments,
especially
in
the
areas
of
compliance
assistance
and
enforcement.
These
types
of
investments
will
no
doubt
be
challenging
given
the
current
economic
condition
of
many
state
budgets,
but
such
resource
commitments
will
prove
to
be
more
than
cost
effective
in
the
future.
EPA
should
consider
contributing
additional
funding
to
states
to
implement
their
own
programs
and
take
steps
to
remove
roadblocks
that
hinder
or
prevent
states
from
receiving
approval
authority
to
administer
such
programs.
State
run
biosolids
programs
can
improve
biosolids
management
practices
by
providing
more
local
technical
support
and
reducing
compliance
activities
associated
with
multiple
permitting
and
regulatory
requirements.

Response
EPA
is
in
general
agreement
with
these
comments.
EPA
appreciates
the
comments
speaking
to
resources
available
to
EPA
and
EPA's
decision
to
allocate
these
resources
to
issues
and
activities
that
can
be
the
most
effective
in
enhancing
public
health.

Counties
EPA
Log
#
28:
Solano
County
Department
of
Environmental
Management
Comment
5.
Biosolids
Management
In
its
response,
the
USEPA
states
that
it
is
"
committed
to
improving
the
effectiveness
of
risk
communication
at
national,
regional,
and
local
levels".
In
addition,
the
USEPA
discusses
an
Information
Sharing
Group
(
ISG)
which
has
representatives
from
Federal
and
State
regulatory
agencies.
Solano
County
DEM
recommends
that
input
from
local
regulatory
agencies
be
sought
as
well.
Nationally,
most
of
the
compliance
monitoring
of
the
existing
Part
503
regulations
is
either
done
through
self
regulation
by
the
biosolids
applicator
or
through
very
limited
monitoring
by
Federal
and
State
agencies,
and
actually
falls
to
local
jurisdictions.
In
the
State
of
California,
few
local
agencies
choose
to
continue
to
allow
the
land
application
of
biosolids
because
concerns
over
long
term
impacts.
Solano
County
and
the
Department
of
Environmental
Management,
as
a
local
government
agency
responsible
for
regulation
of
the
land
application
of
biosolids,
welcomes
USEPA,
2003d
155
USEPA's
efforts
to
improve
risk
communication
and
looks
forward
to
any
opportunity
to
be
an
active
stakeholder
and
provide
input
into
the
biosolids
program.

Response
Please
see
the
Summary
Response
to
this
section
of
this
document.

States
EPA
Log
#
52:
Washington
State
Department
of
Ecology
Comment
As
the
primary
state
lead
witnessing
the
near
devolution
of
the
federal
program
over
the
past
several
years
I
find
myself
somewhat
in
disagreement
even
with
the
basic
way
EPA
describes
its
own
program.
EPA
notes
for
example
that
there
are
enforcement
and
compliance
staff
in
each
regional
office
and
that
EPA
continues
to
meet
its
statutory
obligations.
In
these
regards
I
can
only
conclude
that
EPA
is
somehow
viewing
the
national
program
from
an
almost
diametrically
opposite
position.
Having
staff
for
compliance
and
enforcement
activities
under
the
CWA
is
not
the
same
thing
as
doing
something
with
regard
to
biosolids
program
implementation.
I
have
seen
EPA's
own
data
belying
this
argument.
I
do
not
know
what
is
strictly
meant
by
EPA's
statement
that
it
continues
to
meet
CWA
obligations
for
the
program.
Reports
by
the
OIG
in
recent
years
have
clearly
described
the
opposite
circumstances
of
an
adequately
funded
and
well
implemented
program.
EPA
even
backpedaled
so
far
in
its
interpretation
of
statutory
obligation
as
to
assert
that
the
national
program
is
self­
implementing
and
no
permits
are
required,
yet
it
is
clear
from
reading
of
the
CWA
that
that
standards
for
biosolids
are
to
be
implemented
in
a
permit
program.
Indeed,
if
this
is
not
the
case
then
why
does
EPA
not
dispense
with
the
majority
of
the
review
process
for
proposed
delegation
to
states
and
simply
turn
the
federal
program
over?

I
know
many
states
and
persons
will
recall
clearly
a
time
in
the
not
too
distant
past
when
EPA
went
on
record
as
disinvesting
in
the
national
biosolids
program.
Resources
were
of
course
a
factor
and
will
likely
always
be
a
factor,
but
a
common
thread
throughout
this
process
and
one
clearly
reflected
in
EPA's
present
response
to
the
NRC
report
is
the
persistent
belief
that
biosolids
pose
a
low
risk
to
public
health
and
the
environment
and
therefore
warrant
a
low
priority
in
terms
of
resource
allocation.
EPA
says
in
fact
in
its
response
that
it
has
based
allocation
of
resources
on
its
assessment
of
relative
risks
to
public
health
and
the
environment
from
biosolids.
Respectfully,
this
thinking
is
in
error.

Properly
managed
and
with
proper
oversight,
biosolids
do
not
pose
a
significant
risk
to
public
health
and
the
environment.
It
is
more
than
evident,
however,
that
many
members
of
the
public
and
even
some
agency
staff
at
both
federal
and
state
levels
do
not
share
this
belief.
Concerns
are
only
exacerbated
by
the
common
knowledge
that
EPA
is
not
adequately
implementing
this
program.
In
the
business
of
risk
management
EPA
should
remember
that
perception
=
reality.
Further,
the
capital
and
operating
costs
associated
with
the
production,
treatment
and
management
of
biosolids
from
treatment
works
are
a
significant
portion
of
total
costs,
ranging
to
30­
40%
by
some
accounts.
While
I
do
not
question
that
clean
water
should
be
a
higher
priority
for
national
and
state
environmental
programs,
EPA's
attention
to
the
second
major
effluent
stream
produced
by
treatment
works
has
been
disproportionate
as
compared
to
the
resources
USEPA,
2003d
156
invested
by
treatment
works
and
overall
has
simply
been
inadequate.
Assumptions
that
public
concerns
are
somehow
mollified
by
assurances
of
low
risk
do
not
hold
up
under
even
the
most
casual
scrutiny
where
there
are
conflicts
around
alleged
impacts
to
public
health.
Further
assumptions
that
the
national
program
can
remain
viable
on
a
diet
of
assurances
are
ill­
advised
at
the
very
best.
Not
to
diminish
at
all
the
hard
work
of
many
operators,
consulting
professionals,
scholars,
and
trade
organizations
across
the
country,
it
is
a
simple
fact
that
the
viability
of
the
national
biosolids
program
has
been
largely
sustained
for
several
years
by
a
relative
handful
of
extraordinarily
dedicated
staff
at
the
federal
and
state
levels.
I
do
not
believe
EPA
as
an
institution
has
fully
appreciated
the
level
of
effort
and
sacrifice
that
has
been
required
of
some
of
these
people.
Recognizing
that
some
prioritization
will
occur
and
expecting
that
perhaps
not
all
resources
necessary
can
be
allocated
toward
meeting
the
NRC
recommendations,
EPA
must
cease
the
caveats,
pull­
back
from
ideas
borne
of
program
disinvestment
philosophy,
and
look
within
itself
to
reprioritize
the
funds
necessary
to
adequately
address
the
majority
of
the
critical
issues
identified
in
the
NRC
report.

Regarding
certain
specific
elements
of
the
short
and
long
term
strategies 

Major
Short­
Term
Goal
#
1.
Continue
program
implementation
(
regulatory,
compliance,
and
enforcement).
If
EPA
is
sincere
in
its
statement
of
intent
in
this
case
then
here
is
an
example
which
rather
well
defines
the
contrasting
viewpoints
on
federal
performance.
The
Office
of
Inspector
General
has
criticized
EPA's
implementation
of
the
national
biosolids
program
in
two
consecutive
reports.
Implementation
of
the
federal
program
is
virtually
non­
existent
in
some
respects.
States
have
consistently
criticized
EPA
or
begged
for
action
as
regards
certain
aspects
of
program
implementation.
EPA
has
responded
either
with
disinvestment
philosophy
or
with
a
"
biosolids
is
a
low
priority"
mantra.
The
recommendation
of
this
very
first
major
short­
term
goal
reads
essentially,
continue
the
status
quo.

The
recommendation
should
read,
"
Objectively
assess
the
status
of
national
biosolids
program
implementation
including
the
findings
of
the
Office
of
Inspector
General
and
propose
and
implement
the
best
improvements
that
can
be
managed
over
the
next
two
fiscal
years."
I
believe
there
would
be
support
for
such
a
goal
statement.
Continuing
to
do
what
has
largely
been
deemed
inadequate
seems
neither
laudable
nor
advisable.

Other
Major
Short­
Term
Goals.
The
remaining
six
major
short­
term
goals
can
be
dissected
to
varying
degrees
but
generally
are
acceptable
as
goal
statements,
except
for
the
question
of
prioritization.
I
see
many
of
these
goals
as
interdependent.
One
may
not
be
fully
accomplished
without
the
input
of
another,
or
the
benefit
of
one
cannot
be
recognized
without
the
accomplishment
of
another.
For
example,
if
EPA
accomplishes
the
first
six
goals
for
the
short­
term,
and
yet
makes
no
progress
on
the
seventh
­
a
standardized
incident
response
approach
­
then
much
of
the
merit
of
what
is
accomplished
with
the
preceding
goals
will
not
be
applied
to
critical
case
situations.
Rather
than
look
at
these
short
term
goals
in
strict
order
of
priority,
I
encourage
EPA
to
think
in
terms
of
concurrent
implementation
with
optimum
progress
measured
for
each
goal
by
the
way
it
serves
to
answer
the
needs
of
the
others.
Hopefully
some
of
the
new
USEPA,
2003d
157
staff
in
the
Office
of
Water
(
mentioned
later
in
EPA's
response)
can
assist
in
carrying
out
the
necessary
work
to
accomplish
all
of
these
goals.

Long­
Term
Major
Goal#
1:
Continue
program
implementation
(
regulatory,
compliance,
and
enforcement).
Regarding
program
implementation,
please
refer
to
the
previous
discussion
above
regarding
funding
and
allocation
of
resources.

Other
Major
Long­
Term
Goals.
Generally
the
goals
of
updating
and
strengthening
the
national
program
by
conducting
appropriate
research
and
incorporating
new
information
speaks
to
an
evolving
and
improving
program
(
assuming
adequate
resources).
Such
goals
are
very
supportable.
I
also
support
goal
four
in
particular,
regarding
partnerships.
While
I
will
not
be
hesitant
to
criticize
EPA
for
its
implementation
shortcomings,
one
area
where
the
agency
has
made
some
good
choices
is
in
partnering.
I
see
the
time
as
ripe
for
expanding
partnerships,
strengthening
connections
to
research
institutions
and
tapping
the
expertise
and
support
of
other
agencies
such
as
USDA
and
CDC.
Continued
good
partnering,
however,
requires
a
more
realistic
discussion
of
EPA's
commitment
to
program
implementation
and
an
appropriate
shift
of
resources
to
support
necessary
changes
and
accomplishments.

Response
Please
see
the
Summary
Response
to
this
section
of
this
document.

EPA
Log
#
53:
Michigan
Department
of
Environmental
Quality
Comment
Major
Short­
Term
Goal
#
1.
Continue
program
implementation
(
regulatory,
compliance,
and
enforcement).
Continuation
of
the
Biosolids
program
as
is
currently
practiced
is
not
acceptable.
A
Wastewater
Treatment
Plant
produces
two
major
effluent
streams,
the
treated
water
and
the
biosolids.
The
water
discharge
has
long
been
addressed
by
EPA
and
has
gotten
the
major
amount
of
attention
and
funding.
The
biosolids
produced
were
treated
as
an
afterthought.
In
many
plans
they
are
addressed
as
an
arrow
off
the
page;
"
Biosolids
to
Disposal."
Inadequate
biosolids
planning
has
caused
ongoing
operational
headaches
for
a
significant
number
of
wastewater
treatment
plants
and
those
plants
turn
to
the
states
and
EPA
for
guidance.
In
many
cases
the
biosolids
support
staff
needed
have
simply
not
been
present.
Continuing
in
the
status
quo
is
unacceptable.
The
Agency
must
commit
to
an
increased
program
in
both
resources
and
staffing.

Response
Please
see
the
Summary
Response
to
this
section
of
this
document.
EPA
believes
that
the
action
plan
announced
in
today's
Federal
Register
Notice
"
reinvigorates"
and
improves
EPA
sewage
sludge
program
and
subsequently
enhances
the
visibility
of
environmentally
appropriate
sewage
sludge
management
practices
at
the
local
level.

EPA
Log
#
45:
Florida
Department
of
Environmental
Protection
Comment
Biosolids
Management
 
Regional
Office
Resources:
The
subject
of
resources
for
oversight
by
the
regional
offices,
particularly
field
staff,
are
not
adequately
addressed
by
this
response.
USEPA,
2003d
158
The
current
levels
of
staffing
and
enforcement
by
both
EPA
and
states
were
known
by
the
NRC
panel
during
their
study.
Also,
past
EPA
reports
and
documents
that
were
available
to
the
NRC
panel
would
have
indicated
to
the
panel
the
general
EPA
position
of
basing
funding
for
the
biosolids
program
on
the
assessment
of
relative
risks.
However,
it
was
after
reviewing
this
information
that
the
NRC
panel
came
to
the
conclusion
that
increased
resources
were
needed
and
thus,
made
the
recommendation
that
EPA
increase
oversight
resources.

We
recommend
EPA
consider
increasing
regional
office
resources
as
recommended
by
the
NRC
report.

Biosolids
Management
 
State
Funding:
As
mentioned
above,
despite
knowing
the
current
extent
of
state
programs,
the
NRC
panel
recommended
the
EPA
provide
funding
to
state
programs
to
help
them
provide
additional,
sufficient
levels
of
oversight.
While
it
is
recognized
that
many
of
the
EPA
sponsored
activities
such
as
the
annual
EPA­
funded
state
regulators
meeting,
the
National
Biosolids
Partnership,
the
Biosolids
Data
Management
System,
and
other
activities
are
very
beneficial
to
states
and
are
vital
to
continue,
additional
funding
would
help
states
maintain
and
increase
biosolids
staffing
levels.

Since
statements
in
other
parts
of
the
EPA
draft
response
indicate
that
EPA
is
relying
on
states
for
enforcement
of
biosolids
activities,
it
is
recommended
that
the
EPA
reconsider
the
NRC
recommendation
of
providing
funding
to
states
to
support
the
biosolids
program.

Biosolids
Management
 
PEC:
The
NRC
called
for
the
Pathogen
Equivalency
Committee
(
PEC)
to
be
formally
funded,
supported,
and
officially
sanctioned
as
an
integral
part
of
the
federal
biosolids
program.
However,
it
appears
that
the
EPA
response
only
commits
to
continuing
to
operate
the
PEC
as
it
does
now,
without
formally
allocating
staff
time,
funding,
or
providing
recognition
in
agency
mission
statements.

We
support
the
NRC
recommendations
regarding
the
PEC
and
it
is
recommended
the
EPA
response
be
revised
to
commit
to
this
recommendation.

Response
See
the
Summary
Response
to
this
section
of
this
document.

EPA
Log
#
48
and
39
(
duplicates):
Wisconsin
Department
of
Natural
Resources
Comment
Several
key
areas
should
be
given
special
consideration
by
the
Agency
as
the
evaluation
of
the
biosolids
program
continues
and
future
policy
decisions
are
made.
These
issues
are
of
national
importance
and
include:

1.
The
viability
of
a
national
biosolids
program
which
includes
responsible
biosolids
recycling
will
be
in
question
without
a
firm
commitment
of
resources.
Those
resources
need
to
be
in
both
staffing
levels
and
dollars.
EPA
should:
provide
access
to
expert
technical
support
to
states
and
maintain
a
national
technical
support
program
to
include
the
Pathogen
Equivalency
Committee
USEPA,
2003d
159
(
PEC),
provide
general
program
oversight,
coordinate
and
implement
research
and
a
research
plan,
and
provide
permitting
activities
in
non­
delegated
states.
The
Agency
should
encourage
and
facilitate
state
delegationthrough
the
transfer
of
funds
from
Congress.

2.
Program
priority
should
not
be
based
on
risk
alone,
but
rather
on
the
necessary
level
of
program
support
and
research
to
maintain
its
viability.
Local
restrictive
bans
on
land
application
are
often
in
response
to
a
real
or
perceived
lack
of
oversight
in
a
particular
locale
and
result
from
a
lack
of
public
confidence
in
program
integrity.
Public
confidence
in
program
oversight,
regulatory
adequacy,
and
long­
term
viability
of
Agency
objectives
should
be
considered
when
assessing
priority.

3.
The
issuance
of
permits
to
sludge
generators/
biosolids
recyclers
is
critical
to
demonstrate
effective
oversight
and
ensure
compliance.
A
commitment
is
mandatory
to
achieve
this
either
through
the
NPDES
program,
RCRA,
the
Safe
Drinking
Water
Act,
or
the
Clean
Air
Act.
The
permit
issuance
serves
as
the
link
between
the
regulator
and
the
regulated
entity.
Once
permits
are
issued,
a
standard
protocol
for
compliance
assistance
and
enforcement
can
and
should
be
developed
and
implemented.

Many
of
the
stated
objectives
and
responses
are
laudable.
However,
funding
and
resources
for
any
of
them
is
uncertain
at
best
and
unlikely
at
worst
unless
EPA
as
an
Agency
and
Congress
specifically
commit
them.
The
federal
government
has
contributed
some
25
billion
dollars
in
grants
and
another
7
billion
dollars
in
low
interest
loans
to
allow
for
capital
expenditures
to
provide
adequate
sludge
treatment
in
this
nation
between
1972
and
1999.
This
is
a
tremendous
investment
that
must
be
secured
through
adequately
protective
regulations
and
effective
implementation
of
those
regulations.
Moreover,
the
recycling
of
biosolids
is
a
program
which
demands
public
support
for
long­
term
viability,
and
that
support
comes
from
confidence
in
the
scientific
basis
for
regulations,
adequacy
of
research
initiatives,
and
regulatory
oversight
of
the
program.
While
most
of
the
nation
still
enjoys
strong
support
for
this
important
recycling
program,
there
are
pockets
of
vocal
opposition
which
result
in
restrictive
ordinances
or
bans
and
these
are
generally
in
areas
where
there
is
the
real
or
perceived
belief
that
program
oversight
is
inadequate.
We
have
clear
knowledge
borne
from
experience
that
what
occurs
in
one
state
impacts
other
states
and
thus
this
is
truly
a
national
issue
which
must
be
supported
at
the
federal
level.
Wisconsin
has
a
long­
standing
model
biosolids
program
in
which
more
than
98%
of
biosolids
generators
ultimately
recycle
biosolids.
Without
an
effective
national
program,
if
recycling
does
not
remain
a
viable
option,
the
capital
cost
for
converting
from
land
application
to
disposal
in
licensed
landfills
in
Wisconsin
alone,
would
exceed
315
million
dollars
in
capital
expenditures
and
more
than
40
million
dollars
in
increased
annual
operating
costs.
However,
perhaps
the
most
significant
cost
would
be
the
abandonment
of
a
successful
program
due
to
the
shortsighted
insistence
that
it
is
a
low
risk
program
and
equating
that
with
a
low
priority.
Priority
should
not
be
based
on
risk
alone,
but
rather
on
the
necessary
level
of
program
support
and
research
needs
to
maintain
its
viability.

The
following
comments
are
in
reaction
to
the
Agency's
preliminary
strategy
for
responding
to
the
NRC
report
recommendations.
USEPA,
2003d
160
1.
Section
VII
short­
term
goals
FY
03­
04
and
long­
term
goals
FY
05
and
beyond
­
Goals
to
be
" 
subject
to
available
resources ".
It
is
recognized
that
these
are
austere
budgetary
times
and
that
priorities
must
be
set
to
maximize
the
benefits
of
expenditures.
However,
a
policy
decision
is
needed
at
the
Agency
and
in
Congress
regarding
support
for
this
program.
The
recommendations
in
the
NAS
report
were
made
in
the
context
that
recycling
biosolids
was
conceptually
good
public
policy
but
which
needed
work
done
to
ensure
its
safety
and
resources
to
ensure
its
implementation.
Either
Congress
and
EPA
agree
with
this
or
they
do
not.
A
commitment
of
resources
to
support
the
beneficial
use
program
is
required
now
or
a
commitment
of
resources
to
expand
landfills
or
construct
incinerators
will
become
necessary
in
the
immediate
future.
States
fully
support
the
former.
The
Agency
should
state
its
position
and
financial
commitment
in
either
case.
See
comment
2.

2.
Section
VII.
Short­
term
and
long­
term
goals
1.
States
as
its
goal:
Continue
program
implementation
(
regulatory,
compliance,
and
enforcement).
Less
than
one
tenth
of
one
percent
of
the
Agency's
budget
is
devoted
to
the
biosolids
program
(
NAS
2002,
pg.
54­
55).
In
recent
years
five
letters
have
been
written
by
WDNR
to
EPA
on
behalf
of
all
states
seeking
increased
federal
support
for
the
program.
The
EPA
Inspector
General
has
listed
biosolids
as
one
of
the
Agency's
ten
most
deficient
programs.
Clearly
continuing
in
the
status
quo
is
unacceptable.
The
Agency
must
commit
to
an
increased
program
in
both
resources
and
staffing.
In
addition,
EPA
should
advocate
further
partnering
with
states
through
facilitation
of
the
delegation
process
and
make
funds
available
for
states
to
implement
their
own
program.

3.
Section
VII.
Last
paragraph
assumes
the
same
level
of
funding
in
future
years
as
is
currently
allocated.
If
this
is
true,
then
virtually
none
of
the
proposed
response
objectives
will
be
able
to
be
completed.
EPA
should
be
specific
regarding
the
funding
levels
and
what
can
and
can't
realistically
be
accomplished.
Consideration
should
be
given
to
promoting
research
at
Universities
through
existing
grant
programs.

21.
Section
VIII.
H.
Biosolids
Management
­
Biosolids
Management
Activities
­
It
is
claimed
that
the
number
of
regulatory
staff
in
the
Office
of
Water
(
OW)
at
EPA
Headquarters
has
recently
been
increased.
If
this
is
the
case,
specific
details
should
be
provided.
Within
OW,
the
Office
of
Wastewater
Management,
which
includes
the
Permits
Branch
and
the
Municipal
Technology
Branch
have
not
had
any
staff
increases
of
which
we
are
aware.
Even
the
NAS
report
acknowledged
that
Regional
offices
will
take
enforcement
action
if
necessary
but
there
is
a
complete
lack
of
national
direction
in
assuring
compliance
and
how
to
take
enforcement
action.
EPA
claims
to
meet
its
statutory
requirement
under
the
Clean
Water
Act
pertaining
to
sewage
sludge.
However,
there
continues
to
be
a
complete
absence
of
involvement
by
the
Permits
branch
in
the
biosolids
program
which
is
in
stark
contrast
to
33
USCS
s
1345
(
f).
This
section
states
that
any
permit
issued
under
section
402
of
this
act
which
is
the
NPDES
program,
to
a
POTW
treating
sewage
sludge
shall
include
requirements
for
the
use
and
disposal
of
sludge
unless
they
are
covered
under
a
permit
issued
under
RCRA,
the
Safe
Drinking
Water
Act,
or
the
Clean
Air
Act.
While
40
CFR
part
503
is
enforceable
even
without
a
permit,
it
appears
that
it
is
EPA's
position
that
they
are
therefore
exempt
from
permitting
requirements.
States
disagree
vehemently
and
believe,
as
stated
in
the
report,
that
POTWs
serve
two
equally
important
functions:
to
clean
water
USEPA,
2003d
161
for
discharge
back
to
surface
and
groundwater
and
to
effectively
treat
sludge
such
that
it
can
be
safely
recycled
to
the
environment
or
otherwise
disposed.
Both
are
outfalls
that
should
be
regulated
through
the
NPDES
program.
In
Wisconsin,
this
has
been
done
since
the
mid
1970s
and
has
resulted
in
strong
public
support
for
biosolids
recycling
and
more
than
98%
of
facilities
recycling.
As
stated
previously,
priority
should
not
be
based
on
risk
alone
but
should
consider
what
is
necessary
for
program
viability.
EPA
should
take
and
articulate
a
firm
position
in
this
matter
including
permit
activities.

22.
Section
VIII.
H.
Biosolids
Management
­
Biosolids
Management
Activities
­
It
is
stated
that
EPA
has
revised
Chapter
10
of
its
NPDES
inspection
manual,
which
covers
sludge
treatment
and
biosolids
use.
However,
since
there
is
no
involvement
from
the
permits
branch
of
OW
and
since
sludge
outfalls
are
seldom
if
ever
included
in
effluent
NPDES
permits,
there
is
no
compelling
reason
for
inspectors
to
include
biosolids
in
their
inspection.
This
must
be
mandated
as
a
necessary
component
of
inspections
and
has
not
been
done
to
date.
EPA
should
clearly
state
its
position
on
this
matter
and
articulate
it
for
the
record.

23.
Section
VIII.
H.
Biosolids
Management
­
Biosolids
Management
Activities
­
It
is
stated
that
PCS
is
being
modernized
and
the
recommendations
of
a
biosolids
workgroup,
on
which
I
served,
was
endorsed
by
the
PCS
Executive
Council.
How
firm
a
commitment
will
EPA
make
on
the
record
to
include
all
the
data
elements
the
workgroup
recommended?
It
is
feared
that
since
so
little
reporting
is
required
by
regulation
that
many
of
the
recommendations
will
be
cut
if
the
budget
becomes
tight.
Even
though
many
of
the
elements
are
not
mandated
by
regulation
it
is
believed
that
they
are
mandatory
for
effective
oversight
and
program
assessment.
The
Agency
should
commit
for
the
record
to
include
all
recommended
data
elements.
The
Agency
should
likewise
articulate
their
plans
for
the
existing
Biosolids
Data
Management
System
(
BDMS)
and
both
systems
potential
to
link
to
state
databases.

24.
Section
VIII.
H.
Biosolids
Management
­
Biosolids
Management
Activities
­
It
is
stated
that
EPA
"
will
continue
to
support
and
evaluate
the
activities
of
the
PEC."
As
stated
previously
above,
there
is
currently
woefully
inadequate
support
of
both
resources
and
staff
time
dedicated
to
the
PEC,
and
thus
"
continued"
support
is
an
unacceptable
response.
Please
see
comment
14
above.

25.
Section
VIII.
H.
Biosolids
Management
­
Biosolids
Management
Activities
­
State
Regulations
­
It
is
stated
that
40
CFR
part
503
is
enforceable
without
a
permit.
Even
if
this
is
true,
the
permit
(
under
NPDES
or
other
programs)
is
the
necessary
mechanism
for
tracking
compliance
and
serves
as
the
link
between
the
regulating
authority
and
the
regulated
entity.
This
link
does
not
currently
exist
at
an
adequate
federal
level
and
is
variable
at
the
state
level.
Federal
dollars
should
be
made
available
for
states
to
implement
this
program,
as
it
is
for
the
NPDES
effluent
program,
and
delegation
should
be
facilitated.
As
stated
above
in
comment
21,
enforcement
activity
is
defined
and
initiated
through
the
permit
process.
EPA
should
clearly
state
its
position
on
permitting,
enforcement,
and
state
delegation.

26.
Section
VIII.
H.
Biosolids
Management
­
Planned
Biosolids
Management
Activities
­
It
is
stated
that
EPA
will
set
biosolids
priorities
based
upon
results
of
objectives
presented
in
this
USEPA,
2003d
162
response
and
an
evaluation
in
the
broader
context
of
other
agency
priorities.
EPA
should
consider
in
this
evaluation
not
only
risk
but
also
what
base
line
support
is
necessary
to
maintain
a
viable
recycling
program
and
the
costs
of
allowing
that
program
to
fail.
This
intent
and
details
to
implement
it
should
be
clearly
stated
and
provided
in
the
final
plan.

27.
Section
VIII.
H.
Biosolids
Management
­
Planned
Biosolids
Management
Activities
­
There
is
a
small
but
growing
movement
in
the
nation
to
consider
banning
the
land
application
of
Class
B
biosolids
and
require
treatment
to
meet
Class
A
pathogen
control.
This
alone
will
not
eliminate
odors,
and
will
in
fact
enhance
them
in
some
cases.
Nor
will
it
eliminate
all
other
management
or
pathogen
issues
and
therefore
individuals
may
be
misguided
in
the
belief
that
this
is
a
panacea.
Effective
treatment
at
the
Class
B
level
along
with
effective
site
management
and
regulatory
oversight
is
critical
for
program
success.
The
Agency
should
reaffirm
this
and
provide
the
mechanisms
necessary
to
ensure
its
implementation.

Response
Please
see
the
Summary
Response
to
this
section
of
this
document.
As
stated
before,
today's
action
plan
and
its
implementation
includes
an
appropriate
level
of
EPA
resource
commitment
both
in
terms
of
EPA
personnel
and
extramural
funds.

PA
Log
#
38:
New
England
Interstate
Water
Pollution
Control
Commission
(
NEIWPCC)

Comment
Foremost
among
our
concerns
is
the
continued
relative
low
priority
in
terms
of
oversight
and
resources
that
EPA
has
assigned
to
biosolids
management.
The
National
Research
Councils
findings,
as
described
in
their
June
2002
report
­
Biosolids
Applied
to
Land
(
NRC
Report),
clearly
states:
``
EPA
provides
insufficient
support
and
oversight
to
the
biosolids
program.
EPA
gives
low
priority
to
its
biosolids
program,
because
it
contends
the
risk
from
exposure
to
chemical
and
pathogens
are
low
and
that
land­
application
programs
generally
function
as
intended
and
in
compliance
with
the
regulations.
This
contention
should
be
better
substantiated."

The
NRC
Report
goes
on
to
specifically
recommend
the
following:

EPA
should
strengthen
its
biosolids­
oversight
program
by
increasing
the
amount
of
funding
and
staff
(
technica1and
administrative)
devoted
to
it.

EPA
should
provide
additional
funds
(
not
diverted
funds)
to
states
to
implement
biosolids
programs
and
facilitate
delegation
of
authority
to
states
to
administer
the
federal
biosolids
regulations.

EPA's
response
to
the
Biosolids
Management
findings
and
recommendations
does
not
appear
to
adequately
address
the
resource
issues
raised
in
the
NRC
Report.
EPA's
response
to
the
findings
and
recommendation
contained
in
the
NRC
Report
appear
to
have
been
developed
solely
within
the
Office
of
Water
without
the
support
or
"
buy­
in"
from
policy
makers
within
the
Agency
who
have
the
authority
to
allocate
resources.
Virtually
every
effort
outlined
in
the
response
is
predicated
by
the
repeated
phrase
"
subject
to
available
resources
".
USEPA,
2003d
163
One
particular
statement
in
EPA's
response
to
the
Biosolids
Management
category
that
the
majority
of
the
NEIWPCC
Residuals
Workgroup
members
do
not
agree
with
is
contained
on
page
17391
of
the
Federal
Register
notice,
which
states
­"
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."
The
NEIWPCC
Residuals
Workgroup
is
of
the
majority
opinion
that
there
is
an
imbalance
between
EPA
Regional
Offices
in
terms
of
biosolids
program
enforcement
and
compliance.
In
some
EPA
regions,
federal
biosolids
management
enforcement
or
compliance
activities
are
virtually
nonexistent.

While
the
NEIWPCC
Residuals
Workgroup
agrees
with
the
concept
that
biosolids
management
when
done
in
compliance
with
the
regulations
poses
a
low
risk,
two
indisputable
facts
of
biosolids
management
are
that:
1)
the
pathogen
concerns
associated
with
biosolids
management
have
the
potential
to
pose
significant
risk
in
substandard
management
scenarios,
and
2)
there
remains
a
significant
degree
of
public
skepticism
and
dispute
as
to
the
adequacy
of
the
federal
regulations
and
federal
oversight
that
ensure
that
these
activities
are
conducted
in
a
manner
which
poses
an
acceptable
level
of
risk.
For
the
benefit
of
states
seeking
delegation
and
in
order
to
allow
ERA
to
better
focus
its
limited
biosolids
management
resources,
the
majority
of
NEIWPCC
Residuals
Workgroup
members
encourage
EPA
to
facilitate
the
processing
and
granting
of
state
requests
for
delegation
of
their
biosolids
program.

The
majority
of
NEIWPCC
Residuals
Workgroup
members
believe
that
the
NRC
Report
recomendations,
if
implemented,
will
provide
the
knowledge
necessary
to
either
validate
the
regulation
as
it
currently
stands,
or
to
revise
the
regulation
should
such
an
action
be
warranted.
Validation
and/
or
revision
of
the
regulation,
when
coupled
with
an
elevated
commitment
on
the
part
of
EPA
to
provide
federal
oversight,
guidance,
and
compliance/
enforcement
efforts,
can
only
serve
to
increase
both
the
effectiveness
of
regulatory
programs
at
the
state
level
as
well
as
public
acceptance
of
biosolids
management
practices
at
the
local
level.

These
points
having
been
made,
we
are
in
concurrence
with
the
actions
outlined
in
the
Agency's
response
but
strongly
urge
the
Agency
to
revisit
the
overarching
policy
that
denies
the
program
sufficient
funding
to
successfully
carry
out
this
agenda.

Response
Please
see
the
Summary
Response
to
this
section
of
this
document.

EPA
Log
#
59:
New
Jersey
Department
of
Environmental
Protection
Comment
There
are
many
worthy
short
and
long­
term
goals
identified
(
Section
VII).
The
EPA
needs
to
identify
program
staff
whose
responsibility
it
will
be
to
ensure
implementation
of
the
goals.
Within
the
next
year,
there
are
at
least
two
major
Research
Symposiums
which
should
help
to
establish
a
prioritized
research
agenda.
Without
appropriate
coordination
and
staff
resources
at
the
federal
level,
any
research
effort
will
not
be
optimally
effective
towards
achieving
the
stated
goals.
USEPA,
2003d
164
With
respect
to
a
prioritized
agenda,
the
Department
believes
that
high
priority
should
be
given
to
conducting
field
studies
and
surveys
to
validate
that
Class
A
and
Class
B
treatment
processes
for
pathogens
perform
as
currently
believed.
In
addition,
to
improve
the
rules
for
the
use
or
disposal
of
biosolids,
the
EPA
should
consider
the
NRC
recommendation
to
investigate
additional
indicator
organisms
(
such
as
Clostridium
perfringens)
for
potential
use.

The
Department
believes
that
it
should
be
EPA's
priority
to
facilitate
the
delegation
of
the
biosolids
program
to
qualified
state
agencies
by
reducing
the
resource
burden
required
to
obtain
delegation.
Specifically,
there
are
many
states
that
maintain
superior
biosolids
programs.
Nevertheless,
the
delegation
application
process
results
in
undue
paperwork
and
administrative
burdens.
The
delegation
process
can
and
should
be
greatly
simplified
to
two
elements
by
allowing
states
(
1)
through
their
Attorneys
General
to
certify
the
State's
statutory
and
regulatory
authorities,
and
(
2)
via
letter
from
the
Governor
of
the
state
to
request
program
approval
to
reaffirm
the
State's
commitment
to
carry
out
delegation.
Equally
important,
the
facilitation
of
state
delegation
should
be
encouraged
by
providing
federal
funds
for
states
to
implement
the
program.

Upon
delegation,
the
state
programs
can
relieve
EPA
of
much
of
the
work
involved
in
continuing
to
implement
the
program
(
regulatory,
compliance,
and
enforcement).
This
would
allow
EPA
to
shift
resources
to
address
the
other
NRC
recommendations
and
to
provide
needed
expertise
and
technical
support
to
the
states.
Nevertheless,
a
commitment
of
resources
at
the
federal
level
is
absolutely
essential
to
implement
these
recommendations.
At
a
minimum,
the
EPA
should
fully
fund
at
least
one
position
in
each
of
the
EPA
regions
to
serve
as
biosolids
coordinator.
In
addition,
adequate
staff
positions
must
be
specifically
earmarked
for
the
biosolids
program
to
maintain
a
national
technical
support
program,
general
program
oversight,
research
and
research
coordination,
incident
response
and
human
health
investigations,
and
permitting
activities
in
states
that
do
not
maintain
an
active
biosolids
program.

Response
Please
see
the
Summary
Response
to
this
section
of
this
document.
EPA
has
continued
to
pursue
State
delegation
of
the
Part
503
Standards.
Many
states
have
good
sewage
sludge
programs.
However,
it
is
true
that
only
five
state
programs
have
been
approved
for
administering
the
Part
503
sewage
sludge
program
(
Utah,
Oklahoma,
Texas,
South
Dakota,
and
Wisconsin).
Fifteen
more
states
have
indicated
some
interest
in
obtaining
program
approval,
but
there
are
issues
that
need
resolving,
such
as
self­
audit
restrictions,
insufficient
public
notification,
and
lack
of
state
funding.

TOPIC
I.
GENERAL
OR
OVERARCHING
Summary
Response:
The
NRC
panel
provided
several
overarching
recommendations
to
EPA
in
the
Summary
section
of
their
report
to
stress
their
importance.
The
NRC
Panel
also
elaborated
on
the
overarching
recommendations
by
placing
detailed
discussions
of
these
in
approximately
60
specific
recommendations
which
make
up
the
bulk
of
the
NRC
Report.
Sections
A­
H
of
this
document
have
responded
in
detail,
by
Comment
Topic
Category,
to
all
comments
related
to
USEPA,
2003d
165
NRC
specific
recommendations.
Therefore,
in
this
section
of
this
document,
EPA
is
responding
specifically
to
those
comments
that
were
not
addressed
in
Sections
A­
H
of
this
document.

Academia
EPA
Log
#
51:
Ellen
Z.
Harrison
Comment
General
comments
Thank
you
for
this
opportunity
to
comment
on
EPA's
proposed
response
to
the
National
Research
Council
(
NRC)
recommendations.
As
a
member
of
the
NRC
Biosolids
committee,
I
am
intimately
familiar
with
the
report
and
its
recommendations.
Since
reports
can
end
up
sitting
on
a
shelf,
it
is
helpful
to
have
this
public
airing
of
the
ways
in
which
EPA
plans
to
respond
to
the
recommendations.
The
involvement
of
the
EPA
Office
of
Research
and
Development
in
the
response
is
a
positive
step.

In
general
the
proposed
EPA
response
is
disappointing.
The
NRC
report
raised
many
concerns
and
detailed
many
recommendations.
However,
EPA
seems
to
be
basically
endorsing
the
status
quo
and
proposing
little
that
is
new
or
responsive.

These
are
the
most
glaring
failures
to
address
the
NRC
recommendations:

1.
Human
Health:
Failure
to
commit
to
studies
of
health
at
sites
where
people
reporting
illness.
Failure
to
commit
to
health
surveillance
at
land
application
sites.

2.
Failure
to
recognize
the
serious
limitations
of
the
NSSS
regarding
limits
of
detection
so
that
when
"
failure
to
detect"
is
used
to
eliminate
chemicals
from
consideration,
chemicals
may
be
eliminated
due
to
the
flawed
survey
rather
than
due
to
absence
of
the
chemical
in
sludges.

3.
Failure
to
commit
to
engaging
stakeholders
in
risk
assessment
and
research.

4.
Failure
to
commit
to
revising
risk
assessment
to
include
multi
pathway
aggregate
risks;
risks
to
sensitive
populations;
risks
to
children
and
fetuses;
interactions
between
contaminants
and
pathogens.

5.
Failure
to
require
bulk
EQ
sludges
to
meet
nutrient
and
site
restrictions
6.
Failure
to
commit
to
establishing
regulations
protective
under
reasonably
anticipated
high
risk
conditions.

7.
Failure
to
suggest
increased
emphasis
on/
resources
for
the
sludge
program.

One
aspect
of
concern
in
addressing
any
recommendations
is
that
EPA
continues
to
use
the
same
staff
in
the
Office
of
Water
who
have
been
involved
in
the
development
and
defense
of
the
current
sludge
rules
and
program.
I
recognize
that
these
are
the
people
in
the
agency
with
relevant
USEPA,
2003d
166
knowledge,
but
it
is
not
surprising
that
a
fresh
and
objective
view
is
unrealistic
to
expect
of
people
with
such
a
long
and
vested
interest
in
the
status
quo.

In
responding
to
the
NRC
recommendations
regarding
updating
the
risk
assessment,
ORD
and
not
OW
should
be
engaged.
This
would
both
help
to
involve
people
with
a
fresh
perspective,
but
would
also
involve
people
with
greater
expertise
in
risk
assessment.
It
would
also
promote
more
consistent
risk
assessment
between
the
sludge
program
and
other
EPA
programs.

EPA
mentions
an
incident
investigation
team
that
would
respond
to
reports
of
problems
at
land
application
sites.
Unfortunately,
they
appear
to
be
using
these
same
staff
for
that
team.
The
investigative
reports
by
EPA
of
incidents
to
date
have
not
given
the
people
claiming
harm
from
sludge
applications
confidence
in
the
EPA's
objectivity.
The
incident
reports
are
viewed
as
"
white
washes."
That
makes
it
highly
unlikely
that
complainants
will
cooperate
with
EPA
in
the
future.
There
needs
to
be
an
independent
group
established
to
investigate
complaints,
one
not
comprised
of
government
agencies
or
professional
associations
at
the
federal,
state
or
local
level
that
have
a
stake
in
the
regulation
of
sludges.
There
are
many
qualified
people
who
would
likely
serve
on
such
a
body.
I,
for
one,
would
be
willing
to
serve
on
and
help
to
organize
such
a
group.

Cronyism
is
another
major
concern.
EPA
mentions
a
number
of
current
and
recent
research
and
outreach
efforts
in
the
April
9
document.
A
"
State
of
the
Science"
conference
to
be
held
in
Florida
in
January
provides
an
example
(
p.
17387).
EPA
did
not
undergo
a
competitive
process
to
determine
who
to
fund
to
do
the
conference.
In
discussions
with
OW
staff
prior
to
EPA's
determination
of
who
to
fund
to
work
on
such
a
conference,
I
had
volunteered
to
be
involved
in
organizing
such
an
event.
Not
only
was
I
not
given
the
opportunity
to
"
bid"
on
the
project,
I
was
not
even
included
in
any
way
in
the
planning
(
though
I
had
volunteered
to
serve
on
a
planning
committee).
The
conference
organizers
and
many
of
the
speakers
represent
persons
that
EPA
has
worked
with
closely
on
the
sludge
issue
and
most
have
a
relatively
"
pro"
land
application
viewpoint.
The
speakers
were
not
identified
through
an
open
solicitation,
but
rather
were
hand
picked
by
the
conference
organizers.
This
same
propensity
of
EPA
to
go
to
"
like­
minded"
people
for
research
and
other
activities
can
be
seen
in
their
funding
of
research
through
WERF
or
by
their
selecting
researchers
directly
(
as
in
the
Pennsylvania
project
discussed
below).
EPA
should
work
through
ORD
to
develop
a
competitive,
peer
reviewed
process
to
fund
research
on
sludge.
A
competitive
peer­
reviewed
process
should
also
be
used
by
EPA
to
support
outreach
activities.

Response
See
the
Summary
Response
in
this
section.
New
staff
in
both
the
Office
of
Water
and
ORD
have
been
added
for
the
preparation
of
EPA's
response
to
the
NRC
Report
and
the
preparation
of
results
for
the
screening
activity.
A
few
of
the
current
staff
at
EPA
have
retired
or
are
planning
to
retire
within
the
year.
EPA
views
this
staff
turnover
as
a
positive
aspect
with
respect
to
the
infusion
of
new
ideas
and
fresh
perspectives
in
the
evolving
EPA
sewage
sludge
program.

With
respect
to
ORD
involvement,
ORD
co­
chaired
the
Intra­
Agency
workgroup
that
prepared
the
action
plan
and
the
results
of
the
screening
activity.
Many
of
the
projects
contained
in
Section
VII
B
of
today's
Federal
Register
Notice
are
ORD
projects.
Additionally,
ORD
has
USEPA,
2003d
167
the
lead
in
evaluating
all
of
the
external
studies
described
in
Section
VII
C
of
today's
Notice
and
will
likely
play
a
prominent
role
in
interaction
with
CDC
in
the
anticipated
development
of
a
human
health
incidents
reporting
and
tracking
system
(
Projects
No.
6
and
7
in
Section
VII
B
of
today's
notice).
Finally,
concerning
the
"
Sustainable
Land
Application"
January
2004
conference
in
Lake
Buena
Vista,
Florida,
(
the
objectives
of
the
conference
are
described
under
Project
12
of
today's
FR
notice).
EPA's
Office
of
Research
and
Development
is
one
of
the
sponsors
of
this
conference,
together
with
a
number
of
other
sponsors
and
co­
sponsors.
EPA
is
not
solely
responsible
for
the
organization
of
this
conference
and
the
conference
steering
and
program
committees
included
representatives
from
EPA,
other
government
agencies,
academia,
industry
and
research
organizations.

Public
Interest
EPA
Log
#
49:
The
ReSource
Institute
for
Low
Entropy
Systems
Comment
Summary
The
EPA
should
implement
an
emergency
moratorium
on
the
land
application
of
sewage
sludge.
Congress
should
amend
the
Clean
Water
Act
to
eliminate
language
about
the
"
beneficial
use"
of
sewage
sludge.
Federal
research
on
the
issue
of
land
application
of
sewage
sludge
should
reject
risk
analysis
and
instead
use
the
precautionary
principle
in
its
orientation
toward
public
health
and
environmental
protection.
Federal
research
dollars
should
be
distributed
by
and
directed
to
people
and
organizations
with
no
financial
stake
in
the
sludge
management
industry.

The
regulations
that
govern
the
use
and
disposal
of
sewage
sludge
are
meant
to
protect
public
health
and
the
environment.
They
fall
short
according
the
National
Research
Council,
the
Centers
for
Disease
Control
and
Prevention,
the
Inspector
General
of
the
EPA,
and
an
increasing
number
of
researchers,
medical
professionals,
engineers,
and
activists.

Specific
Suggestions
The
EPA
should
initiate
the
following
action
and
research:
1.
An
immediate
moratorium
on
the
land
application
of
sewage
sludge
2.
Research
into
disposal
options
other
than
land
application
3.
Research
and
support
for
sewer
prevention
(
and
thus
sludge
prevention)
and
not
extending
existing
sewer
lines
4.
Expanded
research
and
economic
support
for
on­
site
waste
treatment
systems
5.
Research
and
support
for
backing
industry
off
of
publicly
owned
treatment
works
6.
Conduct
response
investigations,
targeted
exposure
surveillance
studies,
and
epidemiological
investigations
of
exposed
populations
 
to
document
whether
health
effects
can
be
linked
to
sludge
exposure
7.
Create
and
implement
processes
to
track
allegations
and
sentinel
events
(
compliance,
management,
health
based),
investigations,
and
concerns
USEPA,
2003d
168
Response
EPA
disagrees
with
the
commenter
that
a
moratorium
on
land
application
of
sewage
sludge
is
needed.
EPA's
projects
described
in
today's
FR
notice
address
many
of
the
research
the
commenter
has
suggested.

Citizens
EPA
Log
#
8:
David
A.
Burrows
 
Comment
On
page
17395
of
the
Federal
Register
it
states:
"
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
the
recommendations.''
This
is
a
health
issue
and
EPA
should
be
given
the
resources
and
the
funding
to
respond
in
full
to
the
NRC
Recommendations.

The
application
of
biosolids
to
land
needs
to
be
regulated
by
good,
peer
reviewed
science,
not
industry
desires.
Peer
review
should
occur
at
both
the
study
design
and
draft
report
stages.

Researchers
should
be
selected
through
the
Request
for
Proposal
process.

Research
should
be
carried
out
under
a
variety
of
climatic
conditions.

Research
studies
should
be
tong
term
(
at
least
one
year)
to
mimic
present
use
of
biosolids
applied
to
land
and
to
allow
time
for
possible
regeneration
of
pathogens.

Strong
regulation
by
EPA
is
necessary
because
in
many
states
local
jurisdictions
are
powerless
to
act
to
protect
human
and
environmental
health.
Giving
local
jurisdictions
the
power
to
protect
their
citizens
and
their
environment
would
be
beneficial.

EPA
should
encourage
research
aimed
at
producing
economical
Class
A
biosolids.

Response
Please
see
the
Summary
Response
to
this
section
of
this
document.

EPA
Log
#
17:
Maine
Sludge
Alliance
Comment
We
are
writing
to
express
our
disgust
with
the
EPA
Sludge
Rule.
We
are
tired
of
hearing
that
human
health
and
the
environment
are
not
at
risk.
I
am
Theresa
Pimental
of
the
Maine
Sludge
Alliance.
As
a
Nurse
Practitioner
what
I
have
seen
in
the
field
is
appalling,
but
because
there
is
no
mandate
for
health
assessments
as
a
professional
there
is
no
avenue
for
solutions.

A
Class
B
site
located
behind
the
Benton
Elementary
School
last
fall
made
citizens
up
to
2
miles
away
ill.
One
individual
suffered
from
a
severe
rash.
A
sludge
spreading
operation
in
Unity
contaminated
5
wells,
with
the
cost
of
the
water
filtering
systems
being
born
by
elderly
citizens.
USEPA,
2003d
169
The
Maine
Sludge
Alliance
demands
the
EPA
make
the
necessary
changes
as
specified
by
the
NRC,
NAC,
and
the
Presidential/
Congressional
Commission
on
Risk
Assessments.

Due
to
the
insufficiency
of
the
Part
503
rule,
the
EPA
BIOSOLID
PROGRAM
IS
OUT
OF
CONTROL
AND
CAUSING
IRREPARABLE
DAMAGE
TO
HUMAN
HEALTH
AND
THE
ENVIRONMENT!
The
Data
Gaps
found
are
so
substantial
that
as
a
medical
professional
I
must
say
the
EPA
has
opened
avenues
of
contamination
and
disease
in
the
United
States.

The
Maine
Sludge
Alliance
demands
that
the
Findings
and
Recommendations
of
the
NRC/
NAC
as
follows
be
immediately
incorporated
into
the
Part
503
rule
and
implemented.

Response
Please
see
the
Summary
Response
to
this
section
of
this
document.
NRC
(
2002)
concluded
that
"
There
is
no
documented
scientific
evidence
that
the
Part
503
rule
has
failed
to
protect
public
health,
However,
additional
scientific
work
is
needed
to
reduce
persistent
uncertainty
about
the
potential
for
adverse
human
health
effects
from
exposure
to
biosolids."
EPA
believes
that
the
action
plan
described
in
today's
Federal
Register
responds
positively
to
this
key
NRC
recommendations.

EPA
Log
#
11:
Loudon
Neighbors
Against
Toxic
Sludge
(
NATS)

Comment
While
it
is
a
challenge
for
ordinary
citizens
to
take
on
the
EPA,
State
and
local
governments,
plus
a
multi­
billion
dollar
aggressive
industry,
make
no
mistake
about
our
resolve.
We
believe
the
United
States
should
follow
the
lead
of
the
European
Union,
three
of
whose
countries
(
a
forth
in
the
process)
have
already
banned
sludge
because
of
health
concerns
with
the
other
countries
following
far
stricter
regulations
than
the
US.
We
ask
EPA
to
stop
this
experiment
on
the
American
public
while
the
health
problems
linked
to
sludge
are
thoroughly
and
honestly
researched
by
independent
and
qualified
scientists
who
have
no
ties
to
the
waste
industry.
To
that
end
we
have
already
collected
1,700
signatures
from
17
states
to
the
following
on­
going
petition:

WE,
THE
UNDERSIGNED,
OPPOSE
THAT
LAND
APPLICATION
OF
MUNICIPAL
SEWAGE
SLUDGES
(
BIOSOLIDS)
UNTIL
SCIENTIFIC
STUDIES
BY
INDEPENDENT
RESEARCHERS
WITH
NO
FINANCIAL/
PROFESSIONAL
TIES
TO
SLUDGE
PROMOTION
ARE
COMPLETED
TO
PROVE
SLUDGE
IS
SAFE
FOR
THE
PUBLIC
HEALTH
AND
THE
ENVIRONMENT.
THERE
SHOULD
ALSO
BE
ADEQUATE
FUNDING
TO
CARRY
OUT
AND
ENFORCE
REGULATIONS.

Response
Please
see
the
Summary
Response
to
this
section
of
this
document.
EPA
thank
the
commenter
for
the
views
and
information
provided.

EPA
Log
#
29:
Henry
J.
Staudinger
Comment
I.
Prologue
The
National
Research
Council
("
NRC")
issued
a
series
of
Recommendations
to
help
address
the
persistent
human
health
issues
surrounding
land
application
of
sewage
sludge.
Pursuant
to
an
USEPA,
2003d
170
agreement
with
the
parties
in
Gearhart
v.
Whitman,
EPA
has
requested
public
comments
on
its
planned
response
to
those
recommendations.

These
brief
comments
are
submitted
to
convey
a
deep
concern
that
EPA's
proposed
strategy
is
not
designed
to
adequately
address
the
potential
human
health
issues
when
the
public
is
exposed
to
land­
applied
sewage
sludge.

Response
Please
see
the
Summary
Response
to
this
section
of
this
document.

EPA
Log
#
31:
David
L.
Lewis
Comment
General
Comments
Synagro
Technology,
Inc.
(
OW­
2003­
0058)
argued
that
NRC
recommendations
calling
for
additional
research
are
"
seriously
flawed,"
that
no
extensive
reevaluation
of
any
portion
of
the
rules
governing
land
application
should
be
undertaken,
and
that
additional
research
on
adverse
health
effects
would
be
a
waste
of
taxpayers'
money.
They
advise
that
the
EPA
should,
instead,
devote
its
resources
to
public
education
on
the
benefits
and
safety
of
biosolids
recycling.

Synagro's
recommendations
represent
the
views
of
the
most
vocal
advocates
of
current
practices
within
the
wastewater
treatment
industry.
They
denounce
people
who
report
adverse
health
effects;
and,
much
of
the
underlying
support
for
their
recommendations
is
contradictory,
technically
incorrect,
and
scientifically
outdated.
If
implemented,
the
recommendations
would
only
serve
to
promote
commercial
business
in
the
short­
term
and
not
advance
the
state
of
science.
They
would,
therefore,
be
counterproductive
to
the
viability
of
land
application
in
the
long
run.

Response
EPA
thank
the
commenter
for
the
view
and
information
provided
which
will
be
considered
in
carrying
out
the
planned
activities
described
in
today's
FR
notice.

EPA
Log
#
54:
Citizens
for
a
Future
New
Hampshire
Comment
Sewage
sludge
can
neither
be
monitored
nor
regulated
to
protect
public
health.
The
land
application
of
all
sewage
sludge,
whether
called
"
Class
A"
or
"
Class
B,"
should
be
stopped.
Sludge
should
be
treated
as
a
hazardous
waste.
Future
research
into
sludge­
related
issues
should
be
directed
at:

1.
Disposal
options
that
protect
public
and
environmental
health
(
using
a
precautionary
approach
rather
than
a
risk
assessment
model
for
public
health
goal
setting)
2.
Remediation
for
land
application
sites
contaminated
by
sewage
sludge
3.
Health­
related
studies
on
current
and
potential
victims
of
sewage
sludge
exposure
and
exposure
pathways
4.
Back­
off­
the
sewer
and
sewer
avoidance
programs
in
both
rural
and
urban
communities
USEPA,
2003d
171
We
reject
a
risk
assessment
based
approach
to
sewage
sludge
regulation.
The
kinds
and
combinations
of
all
contaminants
in
sewage
sludge
cannot
be
known.
Sewage
sludge
regulation
should
be
guided
by
a
precautionary
approach,
embodied
in
the
precautionary
principle.

We
ask
that
federal
money
no
longer
be
used
to
support
the
promotion
of
sewage
sludge
as
a
soil
amendment
or
fertilizer.
All
federal
funds
to
the
sewage
industry
trade
organization,
the
Water
Environment
Federation,
and
the
industry's
Water
Environment
Research
Foundation,
should
be
halted.
Government
information
about
and
research
dollars
directed
to
sludge­
related
issues
should
move
through
entities
that
have
no
economic
relationship
to
the
use
or
disposal
of
sewage
sludge.
Non­
profit
organizations,
like
the
Water
Environment
Federation,
that
have
a
significant
number
of
members
who
are
economically
impacted
by
EPA
sludge
regulations
should
have
no
role
in
either
conducting
or
directing
research.

Response
Please
see
the
Summary
Response
to
this
section
of
this
document.

EPA
Log
#
37:
David
A.
Burrows
Comment
The
seven
short
term
goals
and
four
longer
term
goals
listed
on
page
17304
of
the
Federal
Register
are
very
weak
and
place
human
heath
issues
at
a
very
low
priority.
The
goals
use
wording
such
as
"
continue
program
implementation,"
"
evaluate
the
state
of
the
science,"
"
review
available
data,"
"
continue
ongoing
planned
activities,"
"
conduct
a
dialogue,"
"
update
the
scientific
basis,"
"
incorporating
results,"
and
"
continue
activities."
Only
on
two
goals
does
the
wording
state
"
determine"
and
"
begin
conducting."
Significant
new
peer
reviewed
research
is
needed
to
allay
human
health
fears.

When
discussing
its
overarching
recommendations,
the
NRC
Report
(
page
5)
calls
clear
attention
to
the
need
for
EPA
to
conduct
health
related
studies.
Peer
reviewed
research
is
needed.

In
general
terms,
the
EPA
response
to
the
NRC
Report
is
weak
and
lacks
specific
actions.
Too
often
we
read
possibility,
may,
continue,
could,
review,
evaluate
and
other
weak
terms
rather
than
positive
wording
such
as
will,
should,
conduct
and
determine.

There
is
an
apparent
low
priority
for
health
studies.
What
could
be
more
important?
Human
health
studies
should
be
listed
as
EPA's
#
1
category
when
responding
to
the
NRC
Report's
recommendations.

The
EPA
only
mentions
research
they
feel
is
favorable
to
their
position
with
regard
to
the
Part
503
rule.
Research
by
Dr.
David
Lewis
or
"
Bioaerosol
Transport
Modeling
and
Risk
Assessment
in
Relation
to
Biosolid
Placement"
by
Dowd
et
al.
are
never
mentioned.
EPA
should
mention
and
honestly
evaluate
all
relevant
research.

In
the
interest
of
protecting
human
health,
EPA
should
take
a
risk
based
approach
in
assessing
pollutants
and
pathogens
in
sewage
sludge.
USEPA,
2003d
172
The
NRC
Report
states:
"
There
is
no
documented
scientific
evidence
that
the
Part
503
rule
has
failed
to
protect
human
health."
EPA
should
acknowledge
that
due
to
a
lack
of
peer
reviewed
research
data,
there
is
also
no
scientific
evidence
that
the
Part
503
rule
is
protective
of
the
public
health.

Response
The
final
action
plan
described
in
today's
Federal
Register
Notice
has
been
restructured
and
clarification
added
compared
to
the
draft
action
plan
that
was
published
in
the
April
9,
2003
Federal
Register
Notice.
EPA
believes
that
this
has
resulted
in
a
clearer
statement
of
issue
importance,
research
project
goals,
and
research
project
priority
rank
As
stated
earlier
in
this
document,
ambiguity
in
the
proposed
action
plan
has
been
removed
as
much
as
possible
in
the
final
action
plan.
EPA
believes
that
the
process
of
research
planning
and
execution
in
today's
final
action
plan
is
transparent
to
the
reader.

EPA
Log
#
40:
Thomas
F.
Albert
Comment
General
Comment
#
1:
The
draft
EPA
response
is
rather
poor,
lacks
specificity
and
doesn't
respond
well
to
the
57
NRC
recommendations.
The
worst
part
is
that
EPA's
plans
for
health
studies
are
very
weak.
What
most
sludge
impacted
people
want
from
EPA
is
just
not
there.

General
Comment
#
2:
The
report
by
the
National
Research
Council
(
NRC)
contained
345
pages
with
57
specific
recommendations
to
EPA.
If
all
was
well
with
EPA's
sludge
program
the
NRC
report
would
have
been
one
page
(
not
345
pages.)
Obvioiusly
the
NRC
committee
feels
that
EPA
has
lots
to
do
to
document
that
its
sludge
program
really
protects
human
health
and
the
environment.

General
Comment
#
3:
In
general
terms
the
April
9
EPA
response
to
the
NRC
report's
57
recommendations
is
vague,
weak,
and
lacks
specifics
as
to
what
EPA
will
actually
do.

General
Comment
#
4:
In
my
opinion
the
greatest
fault
with
the
EPA
comments
is
EPA's
apparent
low
priority
for
health
studies.
The
NRC
report
ranks
health
recommendations
"
right
at
the
top".
EPA's
response
puts
health
studies
"
right
at
the
bottom.''
Why
doesn't
EPA
put
human
health
studies
at
the
very
top
of
its
plans?

General
comment
#
5:
The
NRC
report,
as
one
of
its
highest
recommendations,
calls
on
EPA
to
quickly
and
carefully
investigate
instances
where
sludge
impacted
people
complain
about
their
health
being
affected.
This
is
also
just
about
the
#
1
desire
of
sludge
impacted
people.
EPA's
response
is
vague
and
not
specific.
EPA
gives
a
clear
picture
of
wanting
to
delay
and/
or
not
do
health
studies
such
as
the
NRC
recommends.
EPA
should
be
severely
criticized
for
its
VERY
POOR
response
to
the
NRC
health
related
recommendations.
One
should
ask,
WHY
does
EPA
not
have
a
clear
and
detailed
plan
for
responding
to
the
NRC
report's
clear
and
detailed
recommendations
regarding
human
health
studies?
It
almost
seems
that
EPA
is
afraid
of
what
it
will
find
if
it
does
the
proper
health
studies.
USEPA,
2003d
173
General
comment
#
6:
The
EPA
comments
only
rarely
mention
Class
B
sewage
sludge.
Sludge
impacted
people,
and
NRC
report,
know
that
Class
B
sludge
is
the
cause
of
most
of
the
problems.
The
NRC
report
repeatedly
recommends
that
EPA
do
health
related
studies
to
find
out:
a)
whether
the
treatment
process
to
make
Class
B
sludge
really
kills
off
"
most"
of
the
germs,
b)
whether
the
site
restrictions
(
set
back
from
homes,
streams,
wells,
etc.)
are
good
enough
to
protect
people,
and
c)
what
health
threat
is
posed
by
wind
blown
germs,
contaminated
water
runoff
onto
neighboring
properties
and
into
streams,
and
contaminated
water
entering
wells.
Unfortunately,
the
EPA
plan
has
no
specific
proposals
to
address
these
concerns.
EPA
should
be
severely
criticized
for
providing
so
little
detail
regarding
health
issues.

General
Comment
#
7:
Unless
peer
reviewed
studies
clearly
show
an
insignificant
human
health
risk
due
to
land
applied
Class
B
sewage
sludge;
a)
Class
B
sewage
sludge
should
not
be
land
applied,
or
at
the
very
least,
b)
Class
B
sewage
sludge
should
not
be
land
applied
within
2
miles
of
human
habitation.
Unless
peer
reviewed
studies
prove
otherwise,
Class
B
sewage
sludge
should
be
viewed
as
a
clear
and
present
human
health
threat,
especially
to
those
already
stressed
due
to
existing
serious
illness
(
cancer,
compromised
immune
system,
etc.).

Due
to
the
acknowledged
lack
of
data,
just
as
there
is
no
documented
scientific
evidence
that
the
Part
503
rule
has
failed
to
protect
public
health,
it
is
equally
true
that
there
is
no
documented
scientific
evidence
that
the
Part
503
rule
HAS
protected
human
health.
In
future
writings,
in
the
interests
of
accuracy,
EPA
should
acknowledge
that
"
due
to
an
acknowledged
lack
of
data
there
is
no
documented
scientific
evidence
as
to
whether
the
Part
503
rule
HAS
OR
HAS
NOT
protected
human
health."

Comment
#
2:
On
page
17384
EPA
sets
forth
its
strategy
for
responding
to
the
NRC
recommendations.
EPA
lists
7
short
term
goals
(
FY03
and
FY04).
EPA
lists
4
longer
term
goats
(
FY05
and
beyond).
The
EPA
strategy
is
INADEQUATE.
The
11
listed
EPA
goals
seem
to
place
human
health
related
issues
near
"
the
bottom."
The
11
listed
EPA
goals
seem
to
focus
primarily
upon
"
continuations",
"
evaluations",
"
reviews",
and
"
updates."
There
seems
little
evidence
of
actually
moving
aggressively,
especially
regarding
the
human
health
issue.

Comment
#
10:
On
page
17384
the
second
"
priority
area"
(
Major
Longer­
Term
Goals)
is
MISLEADING.
The
second
item
states
"
Update
the
scientific
basis
of
Part
503
by
using
FY03/
04
research
or
by
conducting
research
in
priority
areas.
"
At
the
very
least
the
word
"
or"
should
be
changed
to
"
and."
Does
anyone
(
even
EPA)
think
that
EPA
can
"
update
the
scientific
basis
of
Part
503"
just
by
using
FY03/
04
research?
In
view
of;
1
)
the
numerous
NRC
recommendations,
and
2)
the
very
modest
and
rather
vague
EPA
short
term
goals
for
FY03/
04
it
seems
clear
that
EPA
will
need
to
conduct
additional
"
research
in
priority
areas."

Comment
#
12:
On
page
17384
there
seem
to
be
63
lines
of
text
relating
to
the
short
term
and
long
term
goals.
After
reading
the
text
several
times
I
was
impressed
by;
l)
the
lack
of
specificity
of
what
would
actually
be
done,
and
2)
the
repeated
use
of
words
that
imply
vagueness
and
imply
an
emphasis
upon
data
review
(
rather
than
data
collection).
For
example,
consider
the
frequency
of
use
of
the
following
words
in
the
63
lines;
possibly
(
2),
continue
(
5)
,
update
(
2),
review
(
2),
USEPA,
2003d
174
and
evaluate
(
2).
It
seems
like
there
will
be
a
lot
of
continuing
and
reviewing
and
updating
and
evaluating.
Where
are
the
specifics
about
studies
(
especially
health
related
studies)
that
EPA
should
be
doing,
and
planning
to
do
in
order
to
address
the
recommendations
of
the
NRC
report?

Response
Please
see
the
Summary
Response
to
this
section
of
this
document
and
the
EPA
response
to
Comment
Log
No.
37
in
this
section.

Environmental
Groups
EPA
Log
#
7:
Sierra
Club
Comment
In
recent
years
many
concerns
have
surfaced
over
EPA's
policies
for
land
applying
municipal
sewage
sludges
or
biosolids.
Troubling
questions
were
raised
about
the
scientifi
c
basis
behind
the
Agency's
503
sludge
rule
(
40
CFR
Part
503)
(
1),
in
Inspector
General
audits
(
2,3),
hearings
by
the
full
Committee
on
Science
in
the
U.
S.
House
of
Representatives
(
4,
5),
and
studies
of
illnesses
and
deaths
among
residents
living
near
land
application
sites
(
6,7).
The
National
Research
Council
(
NRC)
report,
Biosolids
Applied
to
Land:
Advancing
Practices
and
Practices
(
8),
echoes
many
of
these
concerns.

Concerns
about
EPA's
policy
on
land
applying
sewage
sludges
were
first
voiced
internally
at
EPA
by
Office
of
Research
&
Development
scientists
reviewing
the
proposed
503
sludge
rule
in
1992
(
7).
After
the
rule's
promulgation,
the
Cornell
Waste
Management
Institute
published
a
research
article
warning
that
U.
S.
standards
for
heavy
metals
are
dangerously
lax
compared
with
standards
adopted
in
other
parts
of
the
world
and
that
the
current
U.
S
rules
did
not
appear
to
be
protective
of
human
health,
agricultural
productivity,
or
the
environment
(
9).
In
2002,
the
Sierra
Club
came
to
the
same
conclusion
and
suggested
a
number
of
more
protective
management
strategies
(
10).

Additional
information
appearing
in
the
scientific
literature
and
gathered
by
the
Sierra
Club
(
11)
since
these
developments
paints
a
disturbing
picture
of
EPA
concealing,
dismissing,
and
ignoring
major
problems
associated
with
land
applying
sewage
sludges.
According
to
water
quality
data
collected
by
EPA's
regional
offices
over
the
past
two
decades
(
12),
for
example,
it
is
evident
that
land
applied
sewage
sludges
have
resulted
in
widespread
groundwater
contamination.
Only
a
portion
of
the
data
are
available,
however,
as
EPA
refuse
s
to
publicly
release
the
full
report
on
what
the
document
refers
to
as
"
biosolids
horror
stories."

The
deficiencies
of
the
current
land
application
policy
cannot
be
addressed
by
merely
"
fine
tuning"
the
existing
rules
or
by
issuing
guidance
documents
or
adopting
voluntary
sludge
management
systems.
Long­
term,
a
policy
that
deliberately
allows
the
addition
of
persistent
pollutants
to
the
nation's
farm
and
forest
soil
is
indefensible
(
10).
It
is
ludicrous
for
EPA,
which
is
charged
with
protecting
public
health
and
the
environment,
to
develop
a
policy
that
converts
America's
farmland
into
managed
hazardous
waste
sites
where
farmers
must
carefully
maintain
soil
pH
and
other
environmental
conditions
within
certain
bounds
to
prevent
heavy
metals
and
toxic
organic
chemicals
from
mobilizing.
The
short­
term
benefits
of
this
cheap
means
of
disposing
of
hazardous
USEPA,
2003d
175
chemical
wastes
will
quickly
vaporize
when
efforts
to
immobilize
toxic
wastes
in
the
land
on
which
we
grow
our
food
fail.

The
Sierra
Club
urges
EPA
to
correct
the
longstanding
mismanagement
of
its
biosolids
program
before
irreparable
harm
is
done
to
agriculture,
public
health,
and
the
environment.
The
same
upper­
level
managers
who
developed
and
promulgated
the
503
sludge
rule,
who
have
been
the
subject
of
multiple
Congressional
hearings
and
investigations
by
the
EPA
Office
of
Inspector
General,
still
run
EPA's
biosolids
program
in
the
Office
of
Water
and
the
Office
of
Research
&
Development.
Their
response
to
the
NRC
recommendations,
published
in
the
Federal
Register
(
19),
shows
that
the
Agency
either
lacks
the
broad
scientific
and
technical
expertise
needed
to
deal
with
this
issue
or
is
unwilling
to
take
sufficient
corrective
and
preventative
action.
EPA's
response
does
not
even
acknowledge
any
environmental
or
public
health
problems
associated
with
land
application
of
sewage
sludges.

The
Agency's
current
practice
of
amending
soil
with
tons
per
acre
of
poorly
regulated
industrial
and
human
wastes
will
only
create
another
major
source
of
soil
and
water
pollution.
Lands
treated
under
current
standards
will
eventually
become
too
poisoned
for
agriculture
and
underlying
groundwater
too
contaminated
for
human
use.
The,
EPA
will
have
no
other
recourse
than
to
make
farmers
and
landowners
remediate
their
land
at
an
enormous
financial
cost
few,
if
any,
will
be
able
to
afford.

In
the
meantime,
EPA
offers
no
immediate
relief
to
growing
numbers
of
people
living
near
land
application
sites
and
complaining
of
burning
lungs,
breathing
difficulties,
chronic
gastrointestinal
and
respiratory
infections
and
other
complications.
The
homes
and
properties
they
once
enjoyed
are
inundated
with
swarms
of
flies
and
other
disease
vectors,
the
surrounding
air
filled
with
overwhelming
stench,
and
the
places
where
they
eat
and
sleep
coated
with
sewage
sludge
dusts.

While
committing
to
additional
research
to
respond
to
some
of
these
issues,
EPA
plans
to
channel
its
funding
to
the
same
programs,
individuals,
and
institutional
networks
it
created
for
promoting
land
application
of
sewage
sludge
as
safe
and
beneficial
(
19:
p.
17389
et
passim).
This
same
strategy
produced
the
current
body
of
unreliable
and
inadequate
science
EPA
now
seeks
to
improve.
The
Sierra
Club
finds
this
unacceptable.

In
its
response
to
the
NRC
recommendations,
EPA
promises
to
adhere
to
Guidelines
for
Ensuring
and
Maximizing
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
the
Environmental
Protection
Agency
(
US
EPA
2002b)
However,
EPA's
proposed
strategy
indicates
that
this
guidance
will
only
be
applied
after
research
results
are
compiled
for
dissemination.

The
Agency
does
not
give
similar
assurances
that
the
selection
and
awards
process
for
research
sponsored
or
supported
by
EPA
will
maximize
quality,
objectivity,
and
integrity
of
the
research
(
19:
p.
17384)
To
the
contrary,
EPA's
response
pre­
selects
individuals
and
institutions
who
will
take
lead
roles
in
providing
scientific
data.
These
individuals
and
institution
s
are
longtime
recipients
of
EPA
funding
who
have
historically
supported
the
Agency's
position
and
promoted
land
application
as
safe
and
beneficial.
USEPA,
2003d
176
The
Sierra
Club,
as
well
as
the
Agency's
Inspector
General,
however
question
whether
it
is
in
the
public
interest
for
EPA
to
promote
the
industry
it
regulates
(
2,3).
Funding
scientists
to
conduct
research
for
promotional
purposes
produced
the
current
body
of
science
criticized
in
the
NRC
report.
In
January
2002,
the
Sierra
Club
urged
EPA
to
shift
research
priorities
and
not
spend
tax
dollars
for
"
crisis
management
and
aggressive
PR
campaigns
to
change
public
perception."(
10).
Instead
of
spending
tax
dollars
to
persuade
the
public
that
land
application
is
safe,
EPA
should
be
using
these
funds
to
make
land
application
safer.
The
Sierra
Club
is
concerned
that
EPA
is
subverting
the
concept
of
"
risk
communication"
by
working
with
trade
groups
for
the
sludge
industry,
to
develop
multimedia
public
relations
campaigns
aimed
at
promoting
the
safety
of
sludge
spreading
and
silencing
citizens
and
scientists
who
question
the
adequacy
of
the
current
rules
(
19:
17392)

So
long
as
EPA
continues
to
attack
scientists
who
publish
negative
findings
on
land
application,
the
Agency's
biosolids
program
will
have
no
credibility.
If
land
application
is
to
continue,
it
is
clearly
in
the
public
as
well
as
in
the
Agency's
interest
to
develop
a
research
strategy
based
on
open
competition
and
active
scientific
debate.
The
Congressional
mandate
to
promote
land
application
as
a
viable
option
for
disposing
of
municipal
wastes
should
not
be
used
to
reduce
competition
for
research
funding,
quash
scientific
debate,
or
produce
a
chilling
effect
on
scientists
who
publish
concerns
about
this
controversial
practice.

Response
Please
see
the
Summary
Response
of
this
section
of
this
document.

Municipal
Wastewater
Treatment
Plants
EPA
Log
#
14:
Metro
Wastewater
Reclamation
District
Comment
The
Metro
Wastewater
Reclamation
District
(
Metro
District
or
District)
agrees
with
the
National
Research
Council's
(
NRC)
primary
conclusion
of
its
July
2002
report
entitled
"
Biosolids
Applied
to
Land:
Advancing
Standards
and
Practices"
that
there
is
no
documented
scientific
evidence
that
the
40
CFR
Part
503
rule
has
failed
to
protect
public
health.
The
Metro
District
also
agrees
with
the
NRC
report
'
s
recommendation
that
additional
research
is
needed
to
support
the
scientific
conclusions
developed
in
the
early
1990'
s
that
resulted
in
the
Standards
for
the
Use
or
Disposal
of
Sewage
Sludge.
Addressing
the
NRC
report's
four
overarching
research
recommendations
will
require
substantial
funding
and
years
of
data
collection
and
study
before
the
U.
S.
Environmental
Protection
Agency
(
EPA)
can
determine
if
the
existing
regulatory
requirements
are
adequate
to
protect
human
health
and
the
environment.
Below
are
listed
specific
comments
the
District
has
on
EPA's
proposed
response
strategy.

Response
Please
see
the
Summary
Response
of
this
section
of
this
document.

EPA
Log
#
19:
Metropolitan
Water
Reclamation
District
of
Greater
Chicago
Comment
The
EPA
is
to
be
commended
for
their
approach
in
reviewing
the
existing
sewage
sludge
regulations
in
Part
503
as
mandated
by
the
Clean
Water
Act
Section
405(
d)(
2)(
C).
EPA
USEPA,
2003d
177
has
taken
a
practical
approach
with
respect
to
the
NRC
recommendations,
in
that
the
EPA
recognizes
resource
limitations;
therefore,
recommendations
will
not
be
implemented
to
the
fullest
extent.
Resources
and
efforts
should
be
directed
towards
completing
data
gaps
utilizing
the
latest
technology
and
currently
available
information
rather
than
on
revisiting
old
issues.

We
concur
with
the
EPA's
responses
to
the
National
Research
Council's
(
NRC)
recommendations
for
the
eight
topical
categories
identified
(
survey,
exposure,
risk
assessment,
methods
development,
pathogens,
human
health
studies,
regulatory
activities,
and
biosolids
management).
The
course
of
action
proposed
by
EPA
in
response
to
the
NRC
recommendations
is
reasonable
and
impressive.

It
would
be
advantageous
for
interested
parties,
including
POTWs,
to
be
given
the
opportunity
to
comment
on
the
progress
of
EPA
as
it
implements
the
NRC
recommendations.
EPA
should
be
encouraged
to
tap
into
the
capabilities
and
resources
of
POTWs
to
play
a
role
in
these
efforts.
Up­
to­
date
information
on
the
progress
of
these
efforts
should
be
made
available
on
the
EPA's
website.

We
are
pleased
to
respond
to
this
issue,
and
we
believe
it
is
vital
for
EPA
to
continue
to
commit
resources
to
demonstrate
the
safety
of
biosolids
and
to
continue
to
develop
and
refine
biosolids
regulations.

Response
EPA
generally
agrees
with
these
comments.

EPA
Log
#
47:
Miami­
Dade
County
Water
and
Sewer
Department
(
MDWASD)

Comment
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,
is
appropriate.

MDWASD
supports
EPA's
strategy
for
responding
to
the
NRC
Recommendations.
While
the
NRC
did
a
very
thorough
review,
it
is
neither
practical
nor
feasible
to
implement
all
of
their
suggestions.
MDWASD
encourages
the
short­
term
goals
the
EPA
has
established.
We
emphasize
the
importance
of
continued
program
implementation,
especially
on
a
State
and
Local
level.

Response
EPA
agrees
with
and
appreciates
these
comments.

Unknown
EPA
Log
#
34:
Anonymous
Comment
The
Agencies
response
to
the
NRC
report
is
presently
inadequate.
Several
key
recommendations
were
outright
rejected.
The
NRC
recommended
a
new
national
survey
of
chemicals
and
pathogens
in
biosolids.
The
agency
only
offered
a
vague
and
unspecific
"
less
USEPA,
2003d
178
comprehensive"
study.
The
NRC
also
recommended
"
well­
designed
epidemiological
investigations
of
exposed
populations".
The
EPA
rejection
is
clear
"
At
this
time,
the
agency
does
not
plan
to
conduct
an
epidemiological
study,
as
discussed
in
the
report."

Root
cause
analysis
The
proposed
response
and
the
NRC
report
make
it
clear
the
EPA's
struggle
over
allocating
a
adequate
resources
to
perform
the
research
needed
with
the
severe
budget
limitation
constraints.

To
close
the
ever
increasing
gap
between
the
current
regulations
and
the
studies
required
to
demonstrate
to
the
public
that
the
practice
of
applying
sewage
sludge
to
the
land
if
safe,
a
significant
change
to
the
program
is
necessary.

Response
EPA
believes
that
the
action
plan
described
in
today's
Federal
Register
Notice
does
strengthen
the
Agency's
sewage
sludge
program.
The
resources
that
have
been
allocated
to
EPA
in
FYs
2003­
2005
have
been
largely
devoted
to
research
projects,
the
results
of
which
will
eventually
lead
to
Part
503
amendments,
if
warranted,
to
enhance
public
health
protection
from
the
land
application
of
sewage
sludge.

EPA
Log
#
35:
Anonymous
Comment
I
am
a
retired
physician
and
I
live
in
a
active
adult
community
in
Solano
County,
CA.
My
interests
are
concern
for
the
environment,
travel
and
reading.
The
EPA
is
charged
with
protection
of
human
health
and
the
environment.
The
EPA
has
promoted
land
application
of
biosolids
without
adequate
evaluation
especially
with
regard
to:
1.
effect
upon
public
health
2.
effect
on
quality
of
life
of
the
people
in
those
communities
3.
effect
on
the
environment­
including
surface
and
ground
water,
air,
soil
4.
content­
pollutants/
bioagents
from
medical
facilities,
stormwater,
industry
5.
effects
from
organic
pollutants
6.
inorganic
accumulation
and
sequelae
of
interaction
between
inorganic
and
organic
and
factors
such
as
pH.
etc.
I
DO
NOT
THINK
THE
PROPOSED
PROGRAM
IS
ADEQUATE!
A.
The
EPA
has
not
adequately
tracked
health
complaints
and
it
has
not
done
prospective
studies
of
signs/
symptoms
of
exposed
versus
unexposed
populations
AND
effects
on
immuno­
compromised,
children,
pregnant
women
and
their
children
have
not
been
studied.
B.
People
who
live
in
the
vicinity
of
land
application
have
NO
recourse­
odor
and
quality
of
life
issues:
e.
g.
children
can't
play
outside,
dust
in
the
house,
flies
in
great
quantity;.
Property
values
plummet.
Additionally,
increased
traffic,
damage
to
roads,
congestion,
air
pollution
from
increased
traffic
and
decreased
property
values
are
concerns
to
taxpayers
and
communities.
COMPLAINTS
ARE
IGNORED!!
C.
Although
EPA
claims
we
are
protected
by
503,
regulations
are
ignored
and
policing
is
almost
absent
in
many
communities.
In
Solano
County,
CA,
where
I
live,
signs
are
absent,
gates
often
open,
sheep
and
cattle
graze
on
recently
spread
fields
and
many
have
no
vegetation.
Despite
proposed
restrictions
and
threatened
fines,
trucks
proceed
during
peak
hours,
biosolids
are
spread
during
increased
wind
conditions
and
during
periods
of
threatened
rain.
Biosolids
are
seen
in
the
creeks,
wetlands
and
on
the
highways.
USEPA,
2003d
179
"
Permitted
fields"
have
been
identified
on
land
with
the
primary
protection
area
of
the
DELTA
(
specifically
prohibited)
and
with
the
secondary
areas
of
the
DELTA
and
the
SUISUN
MARSH.
A
"
permitted
area"
adjacent
to
the
intake
of
the
North
Area
Aqueduct
was
identified
and
sheep
and
cows
have
been
seen
grazing
in
the
creek
flowing
into
the
slough­
amazingly,
the
water
is
chronically
contaminated
with
fecal
organisms
and
what
else
and
results
in
expenditures
for
clean­
up.
D.
Many
research
projects
exist­
multiple
drug
resistance
and
sewage
sludge
treatment,
health
sequelae.
The
websites
of
the
European
Union
is
replete
with
studies
way
ahead
of
the
US.
MY
RECOMMENDATIONS
ARE:
1.
stop
land
application
of
biosolids
­
we
don't
know
enough
about
it
and
it
is
potentially
dangerous
2.
Use
biosolids
for
alternate
cover
in
landfills
3.
accelerate
and
encourage
development
of
other
ways
of
dealing
with
sewage
sludge­
pyrolysis,
thermal
degradation,
etc.
4.
Put
money
into
updating
sewage
facilities,
fix
pipes,
encourage
new
procedures,
composting,
separating
trash.
5.
Alternate
energy
development
should
be
mandatory
6.
Stop
listening
to
the
traditionalists
and
trying
to
convince
the
public
that
land
application
is
beneficial.
LET'S
LESSEN
OUR
DEPENDENCE
UPON
OIL!
USE
OUR
TRASH
AND
STOP
WASTING
IT
ON
LAND
APPLICATION
WHERE
IT
IS
POTENTIALLY
HAZARDOUS
TO
OUR
HEALTH
&
ENVIRONMENT!!

Response
Please
see
the
Summary
Response
to
this
section
of
this
document.

Land
Application
Company
EPA
Log
#
26:
Synagro
Technologies,
Inc.

Comment
GENERAL
COMMENTS
In
the
more
than
three
decades
since
the
passage
of
the
Clean
Water
Act
(
PL
92­
500),
the
United
States
has
seen
a
tremendous
growth
and
expansion
of
its
wastewater
infrastructure.
Growth
coupled
with
increasingly
more
stringent
levels
of
treatment
required
to
meet
NPDES
permit
requirements
has
resulted
in
more
wastewater
treatment
residuals.
While
helping
local
governments
meet
the
challenge
of
managing
wastewater
treatment
residuals,
biosolids
provide
a
nutrient
rich,
organic
fertilizer
that
reduces
use
of
chemical
fertilizers.
Other
benefits
include
cost
savings
to
communities;
reduced
fertilizer
costs
and
increased
crop
yields
for
farmers;
strip
mine
reclamation
uses;
and
organic
matter
additions
to
the
soil
which
helps
improve
water
and
nutrient
retention
and
thus,
helps
to
protect
groundwater
and
surface
water
quality.
Biosolids
recycling
also
saves
landfill
space
and
reduces
energy
consumption.

The
National
Academies
of
Science/
National
Research
Council
(
NAS/
NRC)
report,
Biosolids
Applied
to
Land:
Advancing
Standards
and
Practices,
(
Report),
critiqued
the
state­
of­
the­
science
involving
regulation
of
land
applied
biosolids.
The
Report
found
" 
no
documented
scientific
evidence
that
the
Part
503
rule
has
failed
to
protect
public
health"
and
"
a
causal
association
between
biosolids
exposures
and
adverse
health
outcomes
has
not
been
noted."
While
the
Report
gave
land
applications
a
clean
bill
of
health
regarding
public
safety,
the
expert
panel
reported
that
the
scientific
methods
supporting
the
Part
503
rule
adopted
in
1993
have
changed.
They
suggested
that
EPA
consider
reassessing
the
regulations
in
light
of
new
developments
in
risk
assessment
and
other
information.
These
comments
are
intended
to
make
recommendations
to
the
USEPA,
2003d
180
Agency
concerning
how
they
might
address
some
of
the
panel's
suggestions.
These
comments
come
from
a
company
that
has
a
long
history
of
biosolids
land
application;
and
it
is
from
this
operational
experience
and
knowledge
of
the
science
as
well
as
the
practice
that
we
draw
from.

We
are
cognizant
of
the
fact
that
EPA
has
always
viewed
risk
assessment
as
an
iterative
and
dynamic
rather
than
static
process
and
we
support
the
approach
EPA
has
taken.
As
more
data
become
available,
the
Agency
utilizes
the
data
in
the
risk
assessment
framework
to
update
its
knowledge
base
and
the
regulations
that
are
derived
from
this
base.
For
example,
the
new
sewage
sludge
survey
conducted
by
the
Agency
offered
new
information
on
concentrations
of
dioxin
and
dioxin­
like
compounds
in
biosolids
that
are
land
applied,
and
t
his
information
is
a
"
new"
input
into
chemical
risk
assessments.
Thus,
actual
data
can
replace
old
parameters
and
default
assumptions.

EPA
should
rely
on
existing
and
on­
going
research
and
regulatory
data
rather
than
developing
new
data
where
it
is
not
needed.
EPA's
activities
should
be
focused
on
the
areas
where
they
are
most
likely
to
yield
the
most
significant
results.

It
is
important
that
any
new
activities
undertaken
by
EPA
meet
the
requirements
of
the
Data
Quality
Act.
Since
this
is
basically
a
research
agenda,
EPA
should
spend
more
time
on
achieving
greater
quality
assurance
and
meet
the
data
quality
objectives.

This
document
seems
to
have
dropped
the
distinction
between
"
biosolids"
and
"
sewage
sludge".
It
is
important
that
this
distinction,
as
defined
in
the
NRC
report
and
Webster's
Dictionary,
be
maintained.
Biosolids
are
sewage
sludge
that
have
been
treated
(
digested
and
disinfected)
to
meet
stringent
land
application
standards
in
the
40
CFR
Part
503
regulation
or
other
equivalent
land
application
standards
and
used
especially
as
a
fertilizer.
Municipalities
expend
a
lot
of
time,
money
and
resources
in
order
to
convert
sewage
sludge
into
biosolids.
Therefore,
biosolids
are
no
more
sewage
sludge
than
gasoline
is
crude
oil!

Concentrated
animal
feeding
operations
(
CAFOs)
are
referred
to
at
several
places
in
this
document.
Why
CAFOs
are
even
mentioned
in
EPA's
request
for
comments
on
the
NAS/
NRC
report
is
unclear,
because
CAFOs
are
not
discussed
or
referenced
in
the
NAS/
NRC
report.
CAFOs
generate
materials
that
different
than
biosolids
for
many
reasons
including
the
lack
of
treatment
of
animal
manure
at
CAFOs.
Although
CAFO
research
and
indeed
research
on
the
human
health
and
ecological
effects
of
manures
and
other
soil
amendments
and
fert
ilizers
is
important,
it
should
not
be
included
with
biosolids
research
intended
to
address
the
recommendations
of
NAS/
NRC
panel.

Likewise,
the
issue
of
odor
must
be
put
in
a
proper
context
of
being
a
quality
of
life
issue.
The
NAS/
NRC
report
does
mention
odor
several
t
imes
in
this
context,
"
Since
odors
are
a
primary
source
of
public
complaints,
adequacy
of
treatment
cannot
be
over­
emphasized.
Odors
are
a
function
of
treatment
quality
and
are
minimized
with
effective
treatment
and
management".
The
NAS
panel
considered
risks
from
odor,
but
did
not
find
any
epidemiological
studies
to
document
any
problems
in
this
area.
If
odor
were
a
major
concern
t
he
NAS
would
have
said
much
more
USEPA,
2003d
181
about
it
in
its
finding
and
recommendations.
As
noted
in
a
recent
publication
by
CH2M­
Hill
(
National
Research
Council
Report
Finds
No
Health
Risk
from
Biosolids;
Recommends
503
Rule
Updates
and
More
Study),
"
POTW
are
well­
aware
of
odor
concerns.
They
also
know
recent
studies
are
consistently
showing
there
is
no
connection
between
odors
and
health
issues".
Therefore,
it
is
inappropriate
to
make
references
to
studies
that
are
not
applicable
to
odors
from
biosolids.
For
example,
on
page
17389
of
the
Federal
Register
(
Vol.
68,
No.
68/
Wednesday,
April
9,
2003)
it
was
noted
that
"
In
a
collaboration
with
Duke
University,
EPA
has
also
published
a
report
on
the
relationship
between
odor
from
animal
and
wastewater
residuals
processing
facilities
and
land
application
sites
and
potential
health
effects
(
Journal
of
Agromedicine,
Volume
7
(
1),
2000,
ISSN:
1059­
924X)"
this
Schiffman
et
al
article
is
a
summary
of
past
literature
and
a
conference
that
took
place
in
April
1998.
It
is
almost
exclusively
focused
on
animal
waste,
especially
its
management
in
lagoons.
It
does
not
deal
with
municipal
biosolids
and
therefore
is
not
a
relevant
reference
for
biosolids.
Biosolids
are
entirely
different
from
raw,
untreated
and
unregulated
animal
manure,
in
the
odor
they
produce
and
in
other
physical,
chemical
and
biological
properties.
We
know
from
WERF
research
that
manures
are
much
different
in
terms
of
phosphorus
indexing.

While
odors
are
a
major
issue
for
the
public
acceptance
and
product
acceptance
of
certain
types
of
biosolids,
they
impact
quality
of
life
and
are
not
documented
as
causing
human
health
effects.
It
is
important
to
note
that
the
definition
of
environmental
health
from
the
National
Environmental
Health
Association
says
that
environmental
health
and
protection
refers
to
protection
against
environmental
factors
that
may
adversely
impact
human
health
or
the
ecological
balances
essential
to
long­
term
human
health
and
environmental
quality,
whether
in
the
natural
or
man­
made
environment.
This
definition
does
not
include
quality
of
life
unless
there
is
a
direct
health
impact.
Taste,
odor,
and
aesthetics
all
may
be
perceived
as
negative,
but
don't
actually
result
in
an
adverse
health
effect.

In
an
article
by
Dalton
et
al
of
the
Monell
Chemical
Senses
Center
reinforces
the
importance
of
cognitive
bias
on
the
perception
of
irritation
and
health
effects
associated
with
odor.
These
investigators
concluded
that
both
the
perceived
odor
and
cognitive
expectations
about
a
chemical
could
significantly
affect
how
people
respond
to
it,
including
influencing
the
number
of
symptoms.

In
another,
more
recent
article,
Dalton
provides
a
summary
of
the
issues
surrounding
perception
of
odor
and
irritation.
Dalton
makes
a
clear
distinction
between
odor
and
irritation
throughout
the
article.
From
a
physiological
standpoint,
odor
is
perceived
when
the
olfactory
nerve
is
stimulated;
irritation
occurs
when
other
nerves,
often
the
trigeminal
nerve,
are
stimulated.
The
threshold
for
odor
is
different
than
the
threshold
for
irritation
and
irritation
thresholds
may
be
orders
of
magnitude
higher
than
odor
thresholds.
In
this
context,
irritation
is
usually
characterized
as
temporary
burning,
stinging,
tingling,
or
painful
sensation
in
the
eyes
or
upper
respiratory
tract.
It
does
not
need
to
be
so
severe
that
medical
attention
is
required.

Dalton
states
that
both
subjective
and
objective
methods
are
useful
for
evaluating
odor
or
irritation.
Subjective
methods,
known
as
sensory
scaling,
correlate
a
change
in
concentration
and
a
subject's
report
of
perceived
irritation
intensity.
Objective
methods
like
nasal
lateralization
USEPA,
2003d
182
involve
finding
the
concentration
of
a
chemical
that
can
cause
stimulation
of
the
trigeminal
nerve.
The
results
of
subjective
and
objective
methods
should
coincide
except
that
many
non­
physiological
factors
can
affect
subjective
methods.

Dalton
notes
that
there
are
numerous
factors
that
can
influence
an
individual's
perception
of
odor,
irritation,
or
health
effects.
These
include
exposure
history,
expectations,
personality,
beliefs,
social
factors,
and
bias.
She
relates
a
series
of
laboratory
studies
where
people
who
were
told
that
the
chemical
to
which
they
were
being
exposed
was
an
industrial
solvent
reported
more
odor,
irritation,
and
health
effects
that
people
who
were
told
it
was
a
natural
extract.
She
also
notes
that
anxiety
over
the
consequences
of
exposure
can
worsen
the
perception
of
odor
and
irritation.

This
article
is
important
for
several
reasons.
First,
it
confirms
t
he
long­
held
distinction
between
odor
and
irritation.
Second,
when
we
hear
of
odor
complaints,
we
should
realize
that
there
are
many
psychological
and
social
factors
that
influence
perception
of
odor.
For
example,
Simon
Wessely,
a
psychiatrist
at
King's
College
of
Medicine
in
London,
has
been
collecting
reports
of
this
kind
of
hysteria
for
about
ten
years
and
now
has
hundreds
of
examples,
dating
back
as
far
as
1787,
when
mill
workers
in
Lancashire
suddenly
took
ill
after
they
became
persuaded
that
they
were
being
poisoned
by
tainted
cotton.
According
to
Wessely,
almost
all
cases
fit
a
pattern.
Someone
sees
a
neighbor
fall
ill
and
becomes
convinced
that
he
is
being
contaminated
by
some
unseen
evil­
in
the
past
it
was
demons
and
spirits;
nowadays
it
tends
to
be
toxins
and
gases­
and
his
fear
makes
him
anxious.
His
anxiety
makes
him
dizzy
and
nauseated.
He
begins
to
hyperventilate.
He
collapses.
Other
people
hear
the
same
allegation,
see
the
"
victim"
faint,
and
they
begin
to
get
anxious
themselves.
They
feel
nauseated.
They
hyperventilate.
They
collapse,
and
before
you
know
it
everyone
in
the
room
is
hyperventilating
and
collapsing.
These
symptoms,
Wessely
stresses,
are
perfectly
genuine.
It's
just
that
they
are
manifestations
of
a
threat
that
is
wholly
imagined.

Therefore,
if
biosolids
opponents
have
succeeded
in
scaring
people,
the
odor
and
irritation
complaints
are
more
likely
to
be
severe.
Last,
when
studies,
such
as
the
one
currently
being
conducted
by
EPA,
USDA
and
the
State
of
PA
are
reported,
we
need
to
make
sure
that
the
methods
used
were
of
the
highest
scientific
quality
and
capable
of
distinguishing
between
odor
and
irritation.

The
bottom
line
is
that
if
odors
were
considered
a
health
problem,
the
NAS/
NRC
report
would
have
certainly
said
much
more
and
made
strong
recommendations.
Therefore,
any
comprehensive
evaluation
or
study
relative
to
odors
must
be
left
to
another
forum.

We
agree
with
the
Agency's
comments
on
page
17391
of
April
9,
2003
Federal
Register
Notice
with
regard
to:
"
Regulations
from
Other
Nations".
This
is
an
important
statement
and
area
of
concern,
because
many
times
those
opposed
to
the
beneficial
recycling
of
biosolids
make
erroneous
references
to
European
Union
countries
and
the
use
of
the
precautionary
principle.

The
current
trend
in
the
European
Union
countries
is
that
slightly
more
than
50%
of
the
sewage
sludge
generated
by
municipal
wastewater
treatment
plants
is
beneficially
recycled,
primarily
in
USEPA,
2003d
183
the
form
of
agricultural
land
application
because
of
the
nutrient
value
provided
by
its
nitrogen
and
phosphorous
content.
The
currently
governing
regulatory
regime
for
these
countries
is
a
combination
of
the
European
Commission
(
EC)
COUNCIL
DIRECTIVE
86/
278/
EEC
of
June
1986
(
hereinafter
referred
to
as
the
EC
Directive,
or
directive),
and
harmonized
policy
adopted
by
the
individual
member
nations
(
competent
authorities),
and
local
restrictions.

Article
1
of
the
COUNCIL
DIRECTIVE
states
the
purpose
of
the
directive
" 
to
regulate
the
use
of
sewage
sludge
in
agriculture
in
such
a
way
as
to
prevent
harmful
effects
on
soil,
vegetation,
animals
and
man,
thereby
encouraging
the
correct
use
of
such
sewage
sludge."
The
directive's
approach
to
regulate
the
use
of
sewage
sludge
is
to
recognize
that
pathogens
and
metals
are
present,
and
require
treatment
and
concentration
limits
to
prevent
impacts
on
human
health
and
the
environment.
The
directive
also
requires
restrictive
time
periods
after
land
application
and
monitoring
of
the
sludge
and
land
application
sites.

The
regulatory
approach
taken
in
the
directive
has
some
fundamental
differences
and
similarities
to
the
EPA's
Part
503
regulations.

°
The
Part
503
approach
is
based
on
risk
assessment
to
protect
human
health
from
metals
by
setting
both
application
and
concentration
limits.

°
The
directive
sets
metals
limits
based
soil
concentrations.
This
approach
was
influenced
by
the
build­
up
of
metals
in
European
soils
over
2,000­
4,000
years
of
agricultural
use
of
the
land
and
uncontrolled
incineration
with
metals
deposition
on
the
soil.

°
Both
the
directive
and
Part
503
require
treatment
of
sewage
sludge
to
reduce
pathogens.

°
Both
approaches
require
human
contact
restrictions
after
land
application,
and
restrictions
on
consumption
of
treated
crops
and
by
humans
and
feed
crops
by
animals.

The
EC
is
currently
considering
changes
to
the
1986
directive,
and
there
is
a
working
document
under
revision,
(
Working
Document
on
Sludge,
April
27,
2000).
While
this
document
is
in
process,
the
1986
directive
and
member
nation's
harmonized
regulations
continue
to
govern
land
application
in
the
EU
member
states.
The
working
document,
however,
continues
to
encourage
the
beneficial
recycling
of
sewage
sludge
for
the
nutrient
content.

Some
other
trends
worth
noting:

°
Generally,
European
nations
prohibit
the
landfilling
of
sewage
sludge.

°
A
number
of
member
states
prefer
to
reuse
sludge
via
incineration
to
recover
energy
from
the
sludge
as
a
biomass
fuel.
This
is
so
for
Switzerland,
Denmark
and
the
Netherlands.
These
countries
have
either
high
water
tables
or
topographies
that
are
not
conducive
to
land
application,
or
made
the
decision
based
on
public
perception
rather
than
scientific
rationale.
USEPA,
2003d
184
°
The
high­
density
population
of
European
nations
requires
carefully
managed
soils.

°
More
than
90%
of
waste
(
including
animal
waste,
industrial
wastes
and
sludges,
and
municipal
wastewater
sludge)
is
predominantly
animal
manure
that
is
untreated,
(
EC­
CO
4953­
2/
11768­
1,
July
2001).

Furthermore,
European
nations
are
backing
away
from
using
the
precautionary
principle
relative
to
biosolids
recycling.
As
we
all
know,
the
precautionary
principle
is
only
necessary
when
there
is
insufficient
scientific
information
to
safely
regulate
a
product.
That
clearly
isn't
the
case
with
biosolids!

The
danger
in
the
precautionary
principle
is
that
it
distracts
consumers
and
policymakers
from
known,
significant
threats
to
human
health
and
diverts
limited
public
health
resources
from
t
hose
genuine
and
far
greater
risks.
Consider,
for
example,
the
environmental
movement's
campaign
to
rid
society
of
chlorinated
compounds.

By
the
late
1980s,
environmental
activists
were
attempting
to
convince
water
authorities
around
the
world
of
the
possibility
that
carcinogenic
byproducts
from
chlorination
of
drinking
water
posed
a
potential
cancer
risk.
Peruvian
officials,
caught
in
a
budget
crisis,
used
this
supposed
threat
to
public
health
as
a
justification
to
stop
chlorinating
much
of
the
country's
drinking
water.
That
decision
contributed
to
the
acceleration
and
spread
of
Latin
America's
1991­
1996
cholera
epidemic,
which
afflicted
more
than
1.3
million
people
and
killed
at
least
11,000.

Activists
have
since
extended
their
anti­
chlorine
campaign
to
so­
called
"
endocrine
disrupters,"
or
modulators,
asserting
that
certain
primarily
man­
made
chemicals
mimic
or
interfere
with
human
hormones
(
especially
estrogen)
in
the
body
and
thereby
cause
a
range
of
abnormalities
and
diseases
related
to
the
endocrine
system.

The
American
Council
on
Science
and
Health
has
explored
the
endocrine
disrupter
hypothesis
and
found
that
while
high
doses
of
certain
environmental
contaminants
produce
toxic
effects
in
laboratorytest
animals­
in
some
cases
involving
the
endocrine
system­
humans'
actual
exposure
to
these
suspected
endocrine
modulators
is
many
orders
of
magnitude
lower.
It
is
well
documented
t
hat
while
a
chemical
administered
at
high
doses
may
cause
cancer
in
certain
laboratory
animals,
it
does
not
necessarily
cause
cancer
in
humans­
both
because
of
different
susceptibilities
and
because
humans
are
subjected
to
far
lower
exposures
to
synthetic
environmental
chemicals.

Our
detailed
comments
focus
on
the
following
areas:

I.
Conduct
a
new
national
survey
of
chemicals
and
pathogens
in
sewage
sludge
and
biosolids.
II.
Use
improved
risk
assessment
methods
to
establish
better
standards
for
chemicals
and
pathogens.
III.
Develop
a
method
to
investigate
and
track
complaints
involving
human
health
effects
from
nearby
land
application
sites.
IV.
Deficiencies
in
NAS/
NRC
Report.
USEPA,
2003d
185
The
perspective
we
bring
to
these
suggestions
is
that
land
application
performed
in
compliance
with
state
and
federal
regulations
remains
a
negligible
risk
to
human
health
and
the
environment.
We
do
not
believe
that
EPA
needs
to
do
an
extensive
reevaluation
of
any
portion
of
the
rules
governing
the
practice
because
of
the
documented
benefits
and
extremely
low
risks
involved­
there
are
already
hundreds
of
studies
confirming
these
facts.
We
also
maintain
t
hat
EPA
should
remain
neutral
on
which
biosolids
management
option
a
community
should
choose,
but
should
devote
resources
to
public
education
as
to
the
benefits
and
safety
of
biosolids
recycling.
There
is
much
misinformation
being
spread
around,
especially
through
the
Internet,
which
has
scared
many
people
and
caused
decision
makers
in
communities
to
shy
away
from
biosolids
recycling.
Therefore,
we
believe
that
EPA
has
the
obligation
to
be
proactive
in
defending
the
validity
of
the
rules
they
have
promulgated
and
setting
the
record
straight
when
misinformation
is
given
to
the
public.

Response
Please
see
the
Summary
Response
to
this
section
of
this
document.
In
today's
FR
notice,
the
term
"
biosolids"
is
used
interchangeably
with
"
sewage
sludge,"
which
is
defined
in
the
regulations
and
used
in
the
statute.
EPA
agrees
with
the
commenter
and
is
no
longer
referring
to
CAFOs
research
in
today's
FR
notice.
EPA
agrees
with
NRC
recommendation
that
"
Odors
are
a
common
complaints
about
biosolids,
and
greater
consideration
should
be
given
whether
odors
from
biosolids
could
have
adverse
health
effects."
EPA
believes
that
several
projects
and
associated
activities
described
in
today's
FR
notice
will
provide
for
a
better
understanding
and
characterization
of
the
odors,
volatile
chemicals,
and
bioaerosols
that
may
be
emitted
from
land
application
sites,
and
which
could
be
of
potential
health
concerns.
Concerning
the
issue
of
drinking
water
chlorination,
EPA
is
not
responding
to
comments
not
directly
related
to
sewage
sludge.

Association
EPA
Log
#
30:
Tri­
TAC
Comment
Tri­
TAC
appreciates
the
opportunity
to
provide
comments
on
the
U.
S.
Environmental
Protection
EPA's
(
EPA's)
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
(
April
9,
2003;
68
Fed.
Reg.
17379)
(
Response).

Tri­
TAC
is
a
technical
advisory
group
that
includes
representatives
from
the
California
Association
of
Sanitation
Agencies
(
CASA),
the
California
Water
Environment
Association,
and
the
League
of
California
Cities.
Tri­
TAC's
goal
is
to
improve
the
overall
effectiveness
of
environmental
programs
and
ensure
that
regulations
affecting
POTWs
in
California
are
reasonable
and
in
the
publics'
best
interest.
The
constituent
agencies
of
Tri­
TAC
provide
water
and
wastewater
services
to
most
of
the
population
of
California.
USEPA,
2003d
186
Tri­
TAC
supports
the
EPA's
continued
position
that
the
land
application
of
biosolids
is
an
appropriate
and
environmentally
sound
biosolids
management
option
for
municipalities
when
conducted
in
compliance
with
EPA
regulations.
Tri­
TAC
also
supports
EPA's
commitment
to
manage
biosolids
in
full
compliance
with
the
Part
503
rule
and
EPA's
commitment
to
the
National
Biosolids
Partnership's
voluntary
EMS
program.
Tri­
TAC
encourages
EPA's
efforts
to
confirm
that
current
biosolids
management
practices
are
environmentally
sound
and
protect
human
health.

Conclusion
TRI­
TAC
believes
it
would
be
impossible
for
the
Agency
to
address
every
recommendation
contained
in
the
NRC
Report,
even
over
the
next
five
to
ten
years,
and
believes
EPA
must
make
an
effort
to
identify
those
recommendations
that
will
provide
the
most
vital
information
on
the
land
application
of
biosolids.
Tri­
TAC
is
confident
that
those
efforts
related
to
human
health
effects,
specifically
the
exposure­
assessment
studies
and
the
framework
for
human
health
investigations,
and
those
efforts
geared
toward
improving
communication
with
the
public
about
the
federal
biosolids
program
will
provide
the
most
benefit
 
with
the
least
financial
hardship
 
for
the
nation's
POTWs
and
the
communities
they
serve.

TRI­
TAC
appreciates
the
opportunity
to
comment
on
the
EPA's
draft
strategy
for
addressing
the
recommendations
in
the
NRC
Report.

Response
EPA
agrees
with
and
appreciates
these
comments.
The
action
plan
in
today's
Federal
Notice
responds
to
the
most
important
NRC
recommendations
and
explains
EPA's
priorities
in
implementation.

EPA
Log
#
27:
California
Farm
Bureau
Federation
Comment
The
purpose
of
the
U.
S.
Environmental
Protection
Agency
(
USEPA)
notice,
68
FR
17379,
is
to
respond
to
the
July
2002
NRC
report,
"
Biosolids
Applied
to
Land:
Advancing
Standards
and
Practices."
These
comments
will
focus
on
several
particular
policy
and
risk
assessment
issues
that
the
California
Farm
Bureau
Federation
(
CFBF)
believes
the
USEPA
must
investigate
and/
or
reevaluate
if
the
USEPA's
response
to
the
NRC
report
is
to
have
any
real
meaning.
This
includes
a
willingness
to
revise
and
improve
basic
assumptions
underlying
its
risk
assessment
and
regulations,
which
is
the
central
tenet
of
the
NRC's
criticism:

To
assure
the
public
and
to
protect
public
health,
there
is
a
critical
need
to
update
the
scientific
basis
of
the
rule
to
(
1)
ensure
that
the
chemical
and
pathogen
standards
are
supported
by
current
scientific
data
and
risk­
assessment
methods,
(
2)
demonstrate
effective
enforcement
of
the
Part
503
rule,
and
(
3)
validate
the
effectiveness
of
biosolids­
management
practices.

The
USEPA's
reevaluation
of
its
risk
assessment
and
regulations
must
demonstrate
a
greater
commitment
to
the
health
and
safety
of
those
at
risk
from
the
land
application
of
sewage
sludge.
As
will
be
discussed,
contrary
to
the
USEPA's
assumption,
the
"
public
at
large"
does
not
bear
the
risks
of
land
application,
rather,
it
is
those
people
living
and
working
on
the
farms
and
nearby
rural
communities
where
sewage
sludge
is
land
applied
that
bear
all
the
risks.
The
USEPA
USEPA,
2003d
187
repeatedly
has
emphasized
that
the
Part
503
regulations
provide
only
"
minimum
national
standards
for
the
use
or
disposal
of
biosolids."
Considering
the
significant
public
health
and
agricultural
impact
concerns
raised
by
the
land
application
of
sewage
sludge
and
the
general
reluctance
of
states
to
regulate
biosolids
more
strictly,
whether
because
of
financial
or
expertise
concerns,
the
USEPA
must
carefully
reevaluate
all
aspects
of
its
risk
assessment
to
ensure
that
its
minimum
standards
for
land
applying
biosolids
provide
maximum
protection
of
the
public
health
and
long­
term
agricultural
productivity.

Response
Please
see
the
Summary
Response
to
this
section.

EPA
Log
#
50:
Water
Environment
Federation
(
WEF)

Comment
General
Comments
WEF
believes
biosolids
land
application
is
a
safe
practice
when
applied
in
accordance
to
the
Part
503
requirements
and
encourages
EPA's
efforts
to
confirm
that
current
practices
are
environmentally
sound
and
protect
human
health.
WEF
supports
EPA's
continued
commitment
to
reducing
the
public's
uncertainty
related
to
human
health
impacts
while
acknowledging
that
"
there
is
no
documented
scientific
evidence
to
indicate
that
the
Part
503
rule
has
failed
to
protect
human
health,''
as
stated
in
the
NRC
July
2002
biosolids
report.

WEF
supports
EPA's
three
main
objectives
"
for
attaining
a
better
understanding
of
biosolids
and
reducing
the
potential
for,
or
reducing
the
uncertainty
related
to,
human
health
impact."
In
general,
WEF
believes
that
EPA
has
developed
a
thorough
and
sensible
strategy
to
address
concerns
raised
in
the
NRC
report
while
optimizing
the
agency's
limited
funding.
It
is
critical
that
EPA
direct
its
limited
resources
to
areas
that
will
result
in
the
greatest
environmental
benefit,
such
as
increased
oversight
of
ongoing
operations
to
determine
regulatory
compliance,
confirmation
of
safety
and
public
health,
and
strengthening
public
confidence.
WEF
endorses
EPA's
commitment
to
manage
biosolids
in
full
compliance
with
the
Part
503
rule
and
EPA's
commitment
to
support
the
National
Biosolids
Partnership's
Environmental
Management
System
program.

There
are
four
key
elements
to
the
Agency's
strategy
that
WEF
believes
will
ultimately
determine
EPA's
ability
to
address
public
concerns.

Response
EPA
agrees
with
and
appreciates
these
comments.

PA
Log
#
46:
Association
of
Metropolitan
Sewerage
Agencies
(
AMSA)

Comment
The
Association
of
Metropolitan
Sewerage
Agencies
(
AMSA
or
the
Association)
is
pleased
to
provide
comments
on
the
U.
S.
Environmental
Protection
Agency's
(
EPA)
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
(
April
9,
2003;
68
Fed.
Reg.
17379).
Founded
in
1970,
AMSA
represents
the
interests
of
nearly
300
of
the
nation's
publicly
owned
treatment
works
(
POTWs).
AMSA
members
USEPA,
2003d
188
serve
the
majority
of
the
sewered
population
in
the
United
States
and
collectively
treat
and
reclaim
over
18
billion
gallons
of
wastewater
each
day.

The
Agency
Response
details
EPA's
preliminary
review
of
the
July
2002
National
Research
Council
(
NRC)
report
entitled,
Biosolids
Applied
to
Land:
Advancing
Standards
and
Practice
s
(
the
NRC
Report),
as
well
as
the
strategy
EPA
plans
to
use
for
responding
to
the
NRC
Report's
recommendations.
The
Response
also
provides
the
initial
results
of
the
Agency's
ongoing
review
of
existing
biosolids
regulations
under
the
Clean
Water
Act
(
CWA).

AMSA
strongly
supports
the
Agency's
continued
position
that
the
land
application
of
biosolids
is
an
appropriate
and
environmentally
sound
option
for
communities
when
conducted
in
compliance
with
EPA
regulations.
While
the
NRC
found
that
"
there
is
no
documented
scientific
evidence
to
indicate
that
the
part
503
rule
has
failed
to
protect
human
health,"
AMSA
supports
EPA's
efforts
to
reduce
persistent
uncertainty
about
the
potential
for
adverse
human
health
effects
from
exposure
to
biosolids.
The
Agency
Response
makes
it
clear
that
reducing
this
uncertainty
will
be
a
guiding
principle
for
the
Agency
as
its
maps
the
future
of
the
biosolids
program.
Acknowledging
the
limits
of
EPA's
finite
budget,
and
given
the
numerous
recommendations
made
in
the
NRC
Report,
AMSA
recommends
that
the
Agency
maximize
its
resources
by
targeting
those
areas
that
will
directly
address
the
public's
persistent
uncertainty
and
improve
public
confidence
in
the
practice
of
land
applying
biosolids.

As
it
stated
in
its
January
30,
2003
letter
to
Assistant
Administrator
G.
Tracy
Mehan,
III,
AMSA
continues
to
maintain
that
EPA
should
focus
its
resources
on
improving
its
understanding
of
potential
health
effects,
establishing
procedures
for
tracking
and
responding
to
reported
impacts,
and
most
importantly,
improving
communication
with
the
public.

General
Comments
AMSA
supports
the
Agency's
initial
strategy
for
responding
to
the
NRC's
recommendations.
EPA
has
outlined
three
main
objectives
for
attaining
a
better
understanding
of
biosolids
and
reducing
the
potential
for,
and
uncertainty
related
to,
human
health
impacts:
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.
These
objectives
largely
mirror
what
AMSA
has
asserted
must
be
the
Agency's
priorities
for
strengthening
the
biosolids
program.

Conclusion
AMSA
believes
it
would
be
impossible
for
the
Agency
to
address
every
recommendation
contained
in
the
NRC
Report,
even
over
the
next
five
to
ten
years,
and
believes
the
Agency
must
make
an
effort
to
identify
those
recommendations
that
will
provide
the
most
vital
information
on
the
land
application
of
biosolids.
AMSA
is
confident
that
those
efforts
related
to
human
health
effects,
specifically
the
exposure­
assessment
studies,
and
those
efforts
geared
toward
improving
communication
with
the
public
about
the
federal
biosolids
program
will
provide
the
most
benefit
USEPA,
2003d
189
for
the
nation's
POTWs
and
the
communities
they
serve
,
while
further
bolstering
confidence
in
the
Part
503
program.

Response
EPA
agrees
with
and
appreciates
these
comments.

Counties
EPA
Log
#
28:
Solano
County
Department
of
Environmental
Management
Comment
The
Solano
County
DEM
wants
to
commend
the
USEPA
and
the
NRC
for
their
efforts
to
update
the
standards
for
the
land
application
of
biosolids.
Overall,
Solano
County
DEM
believes
the
NRC
report
is
thorough
and
the
USEPA's
strategy
for
response
to
the
NRC
report
as
outlined
appears
to
be
adequate.
However,
Solano
County
DEM
summits
the
following
comments
to
the
USEPA's
response
strategy
for
your
further
consideration
and
incorporation.

In
conclusion,
Solano
County
DEM
believes
that
the
strategy
outlined
by
the
USEPA
for
response
to
the
NRC
report
is
a
sound
approach
that
should
lend
further
information
on
the
impacts
from
the
practice
of
land
application
of
biosolids.
Solano
County
has
an
active
biosolids
land
application
program
and
continues
to
review
scientific
research
and
findings
to
modify
land
application
practices
to
assure
the
safe
use
of
the
product.
Solano
County
DEM
is
supportive
of
any
additional
research
on
the
subject
of
the
land
application
of
biosolids
and
looks
forward
to
any
opportunity
to
provide
input
on
the
subject.

Response
EPA
agrees
with
and
appreciates
these
comments.

States
EPA
Log
#
52:
Washington
State
Department
of
Ecology
Comment
I
want
to
begin
by
acknowledging
the
work
of
the
National
Research
Council
and
the
consideration
given
by
EPA
to
the
recommendations
given
in
the
NRC
report.
I
also
wish
to
acknowledge
the
comments
submitted
by
the
Wisconsin
Department
of
Natural
Resources
in
their
capacity
as
spokes­
agency
for
state
biosolids
programs
in
general.
I
concur
with
the
comments
submitted
by
Wisconsin
DNR,
and
am
also
in
general
concurrence
with
comments
submitted
by
the
New
England
Interstate
Water
Pollution
Control
Commission.
I
have
not
reviewed
the
comments
which
may
have
been
submitted
by
other
agencies
although
I
note
many
similar
concerns
across
the
nation
and
a
strong
if
not
complete
consensus
on
many
issues.

Responses
here
are
based
on
the
four
primary
areas
where
EPA
specifically
requested
input.
Where
possible,
comments
on
specific
elements
of
the
EPA
response
have
been
aligned
with
these
areas.
Some
additional
comments
follow
discussion
of
the
fourth
area
of
interest
and
are
identified
as
Other
Comments.
USEPA,
2003d
190
(
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.

I
believe
EPA's
proposed
short
and
long­
term
strategies
as
outlined
in
Part
VII
of
the
federal
register
response
are
a
positive
foot
forward
in
sustaining
the
national
biosolids
program.
In
the
space
of
less
than
three
columns
EPA
has
proposed
a
great
deal.

Both
the
short
and
long­
term
major
goals
and
priorities
are
immediately
called
into
question,
however,
as
they
are
couched
in
caveats
regarding
available
resources.
I
understand
the
uncertainties
imposed
by
fiscal
periods,
appropriations,
carry­
forward
levels,
and
endless
demands
on
limited
resources.
But
if
there
is
one
over­
arching
concern
I
wish
to
put
forward,
it
is
that
of
funding
and
resource
allocation
for
the
federal
biosolids
program.

Response
EPA
appreciates
the
comments
supporting
the
long
and
short
term
strategies
outlined
in
the
proposed
action
plan
as
published
in
the
April
9,
2003
Federal
Register.
With
respect
to
the
last
paragraph,
the
final
action
plan
described
in
today's
Federal
Register
Notice
has
been
restructured
and
clarification
added
compared
to
the
draft
action
plan
that
was
published
in
the
April
9,
2003
Federal
Register
Notice.
EPA
believes
that
this
has
resulted
in
a
clearer
statement
of
issue
importance,
research
project
goals,
and
research
project
priority
rank
based
on
available
resources
in
FYs
2003­
2005.
As
stated
earlier
in
this
document,
ambiguity
in
the
proposed
action
plan
has
been
removed
as
much
as
possible
in
the
final
action
plan.
EPA
believes
that
the
process
of
research
planning
and
execution
in
today's
final
action
plan
has
been
made
more
transparent
to
the
reader.

EPA
Log
#
45:
Florida
Department
of
Environmental
Protection
Comment
Thank
you
for
the
opportunity
to
comment
on
the
EPA's
draft
response
to
the
National
Research
Council's
(
NRC)
July
2002
report
on
biosolids.
The
extensive
work
and
effort
EPA
has
put
into
the
biosolids
program
to
date
is
recognized
and
appreciated.
Still,
documents
such
as
the
NRC
report
as
well
as
heightened
public
concern
nationally
about
biosolids,
clearly
indicate
that
increased
effort
is
necessary
at
the
federal
level.

Overall,
EPA
appears
to
have
addressed
many
of
the
items
in
the
NRC
report
in
its
draft
response.
However,
there
is
a
very
noticeable
and
significant
difference
between
the
NRC
recommendations
and
the
EPA
response
regarding
the
issue
of
funding
and
resources.

After
reviewing
all
aspects
of
the
biosolids
program,
the
NRC
panel
clearly
and
strongly
recommended
increasing
resources
and
oversight
in
the
biosolids
program
to
"
remedy
deficiencies"
and
to
strengthen
the
biosolids
program.
In
short,
the
NRC
appears
to
believe
that
current
funding
and
resource
levels
are
insufficient
to
ensure
a
successful
biosolids
program.
The
EPA
response,
however,
dismisses
consideration
of
any
increase
in
resources
or
funding.
Furthermore,
the
EPA
response
indicates
that
many
of
the
proposed
activities
in
the
response
may
be
affected
by
future
funding
levels.
USEPA,
2003d
191
It
is
strongly
suggested
that
the
EPA
consider
increasing
resources
and
funding
for
the
biosolids
program
as
recommended
by
the
NRC.

Response
EPA
appreciates
the
comment
regarding
EPA's
response
to
the
NRC's
recommendations
in
the
draft
action
plan.
As
to
the
comments
on
resource
availability,
the
final
action
plan
published
in
today's
Federal
Register
Notice
reflects
a
significant
increase
in
both
research
and
program
implementation
resources
for
the
Agency's
sewage
sludge
program.

EPA
Log
#
38:
New
England
Interstate
Water
Pollution
Control
Commission
(
NEIWPCC)

Comment
In
general,
a
majority
of
the
NEIWPCC
Residuals
Workgroup
members
are
in
agreement
with
and
are
supportive
of
the
efforts
that
EPA
has
outlined
in
its
response.
It
is
our
belief
that
conducting
the
activities
and
studies
described
in
the
response
will
enhance
the
goals
and
effectiveness
of
the
40
CFR
503
regulations
in
protecting
human
health
and
the
environment.
There
are,
however,
several
specific
aspects
of
EPA
'
s
response
that
warrant
more
direct
comment.

Concerning
specific
actions
established
in
the
Agency
'
s
response,
we
strongly
support
the
following
recommendations
of
the
NRC
Report
and
encourage
EPA
to,
minimally,
implement
these
specific
actions:

1)
fully
fund,
support,
and
officially
recognize
the
Pathogen
Equivalency
Committee;
2)
develop
and
approve
microbial
analytical
methods
and
consider
additional
indicator
organisms;
3)
reevaluate
the
current
contaminant
standards
and
the
need
to
establish
standards
for
additional
contaminants
(
if
any)
using
current
state­
of­
the­
art
risk
assessment
models;
4)
facilitate
the
processing
and
granting
of
state
requests
for
delegation
of
their
biosolids
programs;
5)
either
establish
a
realistic
enforcement
and
compliance
presence
for
biosolids
in
each
of
the
EPA
'
s
regions
or
facilitate
the
delegation
of
the
program
to
states
seeking
delegation
­
so
that
these
states
clearly
bear
this
responsibility
and
EPA's
limited
resources
can
be
better
allocated
among
non­
delegated
states;
6)
develop
a
process
for
timely
notification,
recording,
tracking,
and
investigating
incident
reports
in
collaboration
with
the
Centers
for
Disease
Control
and
Prevention;
7)
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;
8)
finalize
the
chlorinated
dioxin/
furan/
coplanar­
PCB
regulatory
action
by
implementing
a
numeric
standard
and
an
appropriate
monitoring
mechanism
that
will
prevent
the
land­
based
management
of
biosolids
containing
concentrations
of
these
compounds
exceeding
the
acceptable
level
of
risk.

Response
EPA
agrees
and
appreciates
the
first
paragraph
of
these
comments.

EPA
Log
#
59:
New
Jersey
Department
of
Environmental
Protection
USEPA,
2003d
192
Comment
The
New
Jersey
Department
of
Environmental
Protection
(
NJDEP)
appreciates
the
opportunity
to
comment
on
EPA's
response
to
the
recommendations
contained
in
the
National
Research
Council's
(
NRC)
report
titled:
Biosolids
Applied
to
Land
B
Advancing
Standards
and
Practices.
In
general,
the
NJDEP
agrees
with
and
supports
the
efforts
that
EPA
has
outlined
in
its
response.
In
addition,
the
Department
supports
the
comments
and
recommendations
made
by
Greg
Kester,
Biosolids
Coordinator
for
the
State
of
Wisconsin,
on
behalf
of
the
state
programs.
There
are,
however,
several
specific
aspects
of
EPA's
response
that
warrant
more
direct
comment
by
this
Department.
The
Department's
comments
are
presented
in
the
format
as
recommended
in
Section
X
of
the
notice.

Overall,
the
Department
is
encouraged
by
many
of
the
recommendations
and
plans
for
action.
However,
the
concern
exists
that
EPA's
plans
may
remain
unfunded
and
may
not
be
implemented
in
a
timely
manner.
It
is
imperative
that
what
limited
funds
are
available
be
used
for
research
projects
that
have
been
prioritized
by
stakeholders.
Also,
care
needs
to
be
taken
to
minimize
the
duplication
of
efforts.
Therefore,
the
Department
believes
that
it
is
important
for
the
EPA
to
identify
staff
resources
that
will
be
dedicated
to
the
biosolids
program
for
the
long­
term
to
ensure
efficient
and
effective
use
of
allocated
resources.

Response
Please
see
the
EPA
response
to
Comment
Log
No.
45
of
this
section
of
this
document
with
respect
to
the
issue
of
limited
funds
devoted
to
EPA's
sewage
sludge
program.
EPA
believes
that
the
resources
devoted
to
items
in
today's
final
action
plan
are
adequate
to
produce
the
needed
information
for
potential
future
amendments
to
Part
503.

Municipalities
EPA
#
55:
City
of
Rio
Vista,
California
Comment
EPA
'
s
plan
does
not
take
grassroots
America
'
s
health
concerns
seriously.
The
legitimate
concerns
of
rural
Americans
are
not
addressed
by
the
plan
and
as
a
result
"
the
persistent
uncertainty
about
the
potential
for
adverse
human
health
effects
from
exposure
to
biosolids
"
will
continue
to
persist..
By
delaying
real
action,
the
EPA
in
effect
decides
that
business
will
continue
as
usual.
Scientific
data
will
continue
to
be
derived
largely
from
research
programs
designed
and
implemented
by
the
wastewater
and
the
land
application
industries,
raising
issues
of
bias
and
credibility.
No
major
new
public
health
investigation
is
proposed
to
satisfy
widespread
citizen
concern.
And
while
the
plan
makes
some
reference
to
citizen
and
stakeholder
"
involvement
",
EPA
does
not
make
a
firm
commitment
to
include
impacted
citizens
in
designing
and
overseeing
all
future
health
research
studies
as
we
had
hoped.
(
See,
e.
g.,
68
Fed.
Reg.
17386:"[
t
]
he
Agency
intends
to
consider
how
consultation
with
stakeholders
should
be
included
in
developing
future
sewage
sludge
risk
assessments."]

EPA
'
s
credibility
with
regard
to
its
biosolids
program
is
squarely
on
the
line.
Communities
such
as
ours
now
know
enough
to
see
past
the
chicken­
and­
egg
response
that
there
is
insufficient
evidence
of
health
risk
to
modify
current
practices.
We
find
it
astounding
that
given
the
concerns
raised
by
the
NRC
report,
EPA
still
"
continues
to
believe
that
land
application
of
biosolids
is
an
USEPA,
2003d
193
appropriate
choice
for
communities,
when
conducted
in
compliance
with
EPA
regulations
(
68
Fed.
Reg.
179392)".
We
respectfully
suggest
that
EPA
revise
its
action
plan
to
add
more
action
on
the
urgent
matter
of
public
health
impacts.
We
urge
the
immediate
involvement
of
the
Centers
for
Disease
Control
and
affected
citizens
in
development
of
an
enhanced
public
health
research
agenda.
We
advocate
that
it
be
EPA
'
s
top
priority
and
adequately
funded.

Response
Please
see
the
Summary
Response
to
this
section
of
this
document.
EPA
understands
that
its
credibility
"
is
on
the
line"
on
how
it
responds
to
the
NRC
recommendations
and,
more
importantly,
on
citizens'
concerns
on
the
land
application
of
sewage
sludge.
In
a
response
to
comments
in
previous
sections
of
this
document,
EPA
has
committed
to
involving
CDC
in
the
human
health
incident
reporting
and
tracking
protocol
development
and
system
implementation.

TOPIC
J.
HOW
DID
EPA
CONDUCT
THE
REVIEW
OF
PART
503
REGULATIONS
UNDER
CWA
SECTION
405(
D)(
2)(
C)?

Summary
Response
The
following
is
excerpted
from
section
VIII
and
X
of
today's
Federal
Register
Notice.
Section
VIII
describes
the
overall
process
that
EPA
undertook
to
select
pollutants
from
an
initial
list
of
803
pollutants
and
then
evaluate
them
through
an
exposure
and
hazard
screening
assessment.
Details
of
this
selection
process,
including
the
list
of
803
pollutants,
are
given
in
Appendix
O
of
the
Technical
Background
Document
for
this
FR
notice.
Section
X
provides
the
results
of
the
hazard
screening
assessment.
For
most
of
the
EPA
responses
to
comments
that
EPA
requested
on
its
review
under
section
405(
d)(
2)(
C)
of
the
CWA
of
the
April
9,
2003
Federal
Register
Notice,
this
Summary
Response
will
serve
as
the
EPA
response.

As
previously
described,
section
405(
d)(
2)(
C)
of
the
CWA
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).
In
1993,
EPA
promulgated
regulations
in
40
CFR
part
503
setting
numerical
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,
EPA
commissioned
the
NRC
study
of
existing
sewage
sludge
land
application
regulations
to
strengthen
its
scientific
review
under
section
405(
d)(
2)(
C).
EPA
agreed
with
the
parties
in
Gearhart
v
Whitman
to
publish
a
preliminary
notice
seeking
public
comment
and
a
final
notice,
stating
the
results
of
its
section
405(
d)(
2)(
C)
review.

In
fulfilling
this
commitment,
EPA
first
collected
and
conducted
a
preliminary
review
of
publicly
available
information
on
the
occurrence
of
chemicals
in
sewage
sludge.
This
information
consists
of
concentration
data
found
in
national
and
international
literature
sources
published
between
1990
and
2002
and
the
1989
National
Sewage
Sludge
Survey
(
NSSS);
data
on
environmental
properties
such
as
mobility
and
persistence;
and
available
human
health
benchmarks
(
HHBs).
EPA
compiled
a
list
of
799
chemical
pollutants
for
which
such
information
was
found
and
described
this
list
of
candidate
pollutants
for
ongoing
sewage
sludge
evaluation
in
the
April
USEPA,
2003d
194
2003
Federal
Register
notice.
EPA
placed
the
full
list
of
candidate
pollutants
in
the
docket
for
public
review
and
comment
(
USEPA,
2003a).
EPA
made
minor
corrections
to
the
list,
which
resulted
in
slightly
revising
the
list
from
799
candidate
pollutants
to
803
candidate
pollutants.
See
Table
1
in
Appendix
O
of
the
Technical
Background
Document
(
TBD)
(
USEPA,
2003b).

EPA
then
used
a
human
health­
based
data
evaluation
and
pollutant
selection
process
to
determine
whether
the
existing
data
were
sufficient
for
each
of
these
803
pollutants
to
proceed
with
an
exposure
and
hazard
screening
assessment.
This
process
involved
identifying
the
pollutants
for
which
EPA
peer­
reviewed
final
HHBs
are
available,
and
for
which
there
are
data
on
concentrations
in
U.
S.
sewage
sludge
for
those
pollutants
with
HHBs,
either
in
the
NSSS
or
reported
in
the
literature.

In
summary,
a
pollutant
was
selected
from
the
list
of
803
pollutants
for
an
exposure
and
hazard
screening
assessment
if
it
met
two
criteria:
(
1)
it
has
measured
concentrations
in
U.
S.
sewage
sludge
based
on
the
literature,
or
it
had
been
measured
in
the
1989
NSSS;
and
(
2)
it
has
a
HHB
from
one
of
two
sources
that
was
not
undergoing
reevaluation
as
of
October
1,
2003.
The
sources
for
HHBs
were
EPA's
Integrated
Risk
Information
System
(
IRIS)
health
assessments
and
EPA's
Office
of
Pesticide
Programs
(
OPP)
Reregistration
Eligibility
Decisions
(
REDs)
or
Interim
Reregistration
Eligibility
Decisions
(
IREDs).
Figure
1
depicts
the
steps
involved
in
this
process.
USEPA,
2003d
195
No
further
evaluation
at
this
time
Was
the
chemical
previously
evaluated
&
determined
not
to
be
a
hazard?

Is
a
human
health
benchmark
available
from
a
final
IRIS
or
OPP
assessment?
Yes
Yes
No
No
Is
an
IRIS
or
OPP
assessment
ongoing
?
Is
the
chemical
already
regulated
in
Round
One?

No
Yes
No
Yes
Yes
Figure
1.
Human
Health­
Based
Pollutant
Selection
Process
No
further
evaluation
at
this
time
No
further
evaluation
at
this
time
Were
measured
concentrations
in
US
sludge
reported
in
the
NSSS
or
in
the
literature
search?

No
further
evaluation
at
this
time
Prioritize
for
possible
inclusion
in
a
targeted
survey
Candidate
chemicals
for
exposure
and
hazard
screening
(
40)
No
Chemicals
reported
in
sewage
sludge
&
having
HHB
from
a
variety
of
sources
Candidate
chemicals
for
sewage
sludge
screening
(
803)
USEPA,
2003d
196
Applying
this
process
resulted
in
a
list
of
40
pollutants
that
merited
exposure
and
hazard
screening.
These
40
pollutants
are
listed
in
Table
1.

Table
1:
Candidate
Pollutants
for
Exposure
and
Hazard
Screening
Chemical
CASRN
Acetone
67­
64­
1
Acetophenone
98­
86­
2
Anthracene
120­
12­
7
Azinphos
methyl
86­
50­
0
Barium
7440­
39­
3
Benzoic
acid
65­
85­
0
Beryllium
7440­
41­
7
Biphenyl,
1,1­
92­
52­
4
Butyl
benzyl
phthalate
85­
68­
7
Carbon
disulfide
75­
15­
0
Chloroaniline,
4­
106­
47­
8
Chlorobenzene;
Phenyl
chloride
108­
90­
7
Chlorobenzilate
510­
15­
6
Chlorpyrifos
2921­
88­
2
Cresol,
o­
;
2­
Methylphenol
95­
48­
7
Diazinon
333­
41­
5
Dichloroethene,
1,2­
trans­
156­
60­
5
Dichloromethane;
Methylene
chloride
75­
09­
2
Dioxane,
1,4­
123­
91­
1
Endrin
72­
20­
8
Ethyl
p­
nitrophenyl
phenylphosphorothioate;
EPN;
Santox
2104­
64­
5
Fluoranthene
206­
44­
0
Hexachlorocyclohexane,
alpha­
319­
84­
6
Hexachlorocyclohexane,
beta­
319­
85­
7
Isobutyl
alcohol
78­
83­
1
Manganese
7439­
96­
5
Methyl
ethyl
ketone
78­
93­
3
USEPA,
2003d
Chemical
CASRN
197
Methyl
isobutyl
ketone
(
MIBK);
Methyl­
2­
pentanone,
4­
108­
10­
1
Naled
300­
76­
5
Nitrate
14797­
55­
8
Nitrite
14797­
65­
0
N­
Nitrosodiphenylamine
86­
30­
6
Phenol
108­
95­
2
Pyrene
129­
00­
0
Silver
7440­
22­
4
Trichlorofluoromethane
75­
69­
4
Trichlorophenoxy
propionic
acid,
2­
2,4,5­;
Silvex
93­
72­
1
Trichlorophenoxyacetic
acid,
2,4,5­;
2,4,5­
T
93­
76­
5
Trifluralin
1582­
09­
8
Xylenes
(
mixture)
1330­
20­
7
Data
collection
and
evaluation,
along
with
the
results
for
determining
sufficiency
of
data
to
proceed
with
an
exposure
and
hazard
screening
assessment
for
a
pollutant,
are
available
in
detail
in
Appendix
O
of
the
TBD
(
USEPA,
2003b).

As
described
by
Figure
1,
EPA
did
not
include
pollutants
for
which
the
scientific
basis
for
the
HHBs
is
currently
being
reassessed.
This
applied
to
certain
chemicals
with
HHBs
in
IRIS
or
OPP's
IREDs
and
REDs.
EPA
has
not
included
these
chemicals
in
the
list
of
chemicals
to
consider
for
exposure
and
hazard
screening
assessment
at
this
time
because
these
HHBs
are
critical
to
determining
whether,
and
at
what
level,
pollutants
might
be
of
potential
hazard
in
sewage
sludge.
Because,
under
section
405(
d)(
2)(
C),
EPA
is
required
to
review
the
sewage
sludge
regulations
for
identification
of
additional
toxic
pollutants
every
two
years,
EPA
has
deferred
chemicals
with
ongoing
health
assessments
for
a
future
review
when
the
assessment
is
complete.
EPA
believes
that
the
HHB
reassessments
will
provide
valuable
information
relevant
to
possible
further
regulation
of
sewage
sludge
once
they
are
complete
and
that
it
would
be
premature
to
include
these
pollutants
in
a
hazard
screening
process
at
this
time.

At
the
same
time,
EPA
recognizes
that
some
of
the
chemical
pollutants
which
are
undergoing
HHB
reevaluation
may
be
of
concern
in
sewage
sludge,
and
that
it
may
be
prudent
to
include
such
pollutants
in
the
planned
targeted
survey
(
i.
e.,
Section
VII.
B,
Project
5)
so
that
USEPA,
2003d
1
The
NRC
recommended
that
EPA
evaluate
risks
based
on
"
reasonable
maximum
exposure"
(
RME).
Therefore,
in
the
hazard
screening
assessment,
EPA
uses
a
risk
level
of
1E­
5
to
calculate
the
RME
to
a
subpopulation
of
highly
exposed
individuals,
rather
than
a
1E­
6
risk
level
to
calculate
risk
to
the
general
population.
A
risk
level
of
1E­
5
is
consistent
with
setting
such
a
risk
level
for,
and
being
protective
of,
the
RME
in
the
sewage
sludge
regulations.
Members
of
the
subpopulation
defined
as
subject
to
RME
are
farm
families
assumed
to
live
on
a
farm
and
consume
farm­
raised
foods
where
land­
applied
sewage
sludge
is
used
as
fertilizer
or
a
soil
amendment
and,
therefore,
are
more
highly
exposed
to
sewage
sludge
than
the
general
population.

198
concentration
values
in
sewage
sludge
may
be
obtained
and
used
in
future
section
405(
d)(
2)(
C)
reviews.
Therefore,
EPA
used
a
simple
estimate
of
potential
hazard
to
prioritize
chemicals
with
ongoing
health
assessments
for
possible
inclusion
in
the
targeted
survey.
The
simple
estimate
involved
calculating
a
theoretical
hazard
quotient
(
THQ)
for
each
of
the
20
chemicals
with
ongoing
IRIS
or
OPP
health
assessments
using
existing
oral
human
health
benchmarks.
The
THQ
is
the
ratio
of
the
theoretical
average
daily
intake
(
TADI),
for
a
1­
3
year
old
child,
one
of
the
most
highly
exposed
population
groups
on
a
kg
body
weight
basis,
to
the
oral
critical
dose
(
OCD),
where
the
OCD
(
in
milligrams/
kilograms/
day,
or
mg/
kg/
day)
is
the
lowest
of
the
reference
dose,
population
adjusted
dose,
or
dose
for
10­
5
cancer
risk1.
On
this
basis,
a
prioritization
scale
was
established
for
the
20
chemicals
with
ongoing
IRIS
or
OPP
health
assessments,
which
have
existing
oral
human
health
benchmarks.
Using
this
priority
scale
and
results
of
the
exposure
screening
assessment,
EPA
decided
which
chemicals
to
consider
high
priority
for
potential
health
concern
and,
subject
to
the
availability
of
adequate
budgetary
resources,
to
include
in
the
targeted
survey
to
be
initiated
in
FY
2005.
These
are
benzo[
a]
pyrene,
PCB
congeners
and
Aroclors
(
excluding
coplanar
PCB
congeners
already
included
in
the
2001
dioxins
survey),
di(
2­
ethylhexyl)
phthalate,
thallium,
antimony,
carbon
tetrachloride
and
fluoride.
This
prioritization
strategy
is
further
described
in
Appendix
O
of
the
Technical
Background
Document
(
USEPA,
2003b).
These
pollutants
are
not
being
identified
at
this
time
for
purposes
of
further
regulatory
consideration
as
part
of
EPA's
current
review
under
section
405(
d)(
2)(
C).

As
mentioned
above,
the
40
pollutants
listed
as
a
result
of
the
selection
process
depicted
in
Figure
1
were
next
analyzed
through
an
exposure
and
hazard
screening
process.
The
principal
objective
was
to
evaluate
whether
the
Agency
should
consider
any
of
these
as
additional
toxic
pollutants
for
regulation
in
sewage
sludge
under
section
405(
d)
of
the
CWA.
As
discussed
in
Section
X,
the
screening
assessment
identified
15
pollutants
with
hazard
quotient
(
HQ)
values
equal
to
or
greater
than
one.

The
results
of
the
hazard
screening
assessment
contained
in
section
X
identify
those
pollutants
which
EPA
is
considering
for
rulemaking
under
section
405(
d)
at
this
time.
These
results
also
indicate
which
exposure
pathway
or
pathways
should
be
the
focus
of
further
consideration
with
respect
to
these
pollutants.
EPA
has
identified
15
pollutants
in
its
review
under
section
405(
d)(
2)(
C).
The
results
of
EPA's
review
do
not
mean
that
EPA
has
concluded
that
these
pollutants
in
sewage
sludge
adversely
affect
human
health
or
the
environment.
The
magnitude
of
the
hazard
indices
discussed
previously
do
not
indicate
the
absolute
risk
for
a
pollutant/
pathway.
The
results
of
EPA's
review
mean
that
EPA
will
obtain
updated
concentration
data
and
conduct
a
USEPA,
2003d
199
refined
risk
assessment
using
the
data
to
determine
whether
to
propose
amendments
to
Part
503
in
order
to
regulate
any
of
these
pollutants
under
section
405(
d)
of
the
CWA.

In
summary,
of
the
40
pollutants
evaluated
in
the
screen,
15
pollutants
have
HQs
that
either
exceed
one
for
human
health
or
are
equal
to
or
greater
than
one
for
wildlife
species
(
see
Tables
5
through
8),
as
summarized
in
Table
8:

Table
8.
Summary
Table
of
the
15
Pollutants
With
HQs
That
Either
Exceed
One
for
Human
Health
or
are
Equal
to
or
Greater
Than
One
for
Ecological
Receptors
Chemical
Receptor
Sewage
Sludge
Scenario
Agricultural
Land
Application
Surface
Disposal
Incinerator4
Acetone
Sediment
biota
x
Anthracene
Sediment
biota
x
Barium
Aquatic
community
Adult
Child
x
x
x
Beryllium
Aquatic
community
x
Carbon
disulfide
Sediment
biota
x
4­
Chloroaniline
Aquatic
invertebrates
Adult
Child
x
x
x
Diazinon
Sediment
biota
x
Fluoranthene
Aquatic
community
Sediment
biota
x
x
Manganese
Aquatic
community
Adult
Child
x
x
x
Methyl
ethyl
ketone
Sediment
biota
x
Nitrate
Adult
Child
x
x
Nitrite
Adult
Child
x
x
x
USEPA,
2003d
Chemical
Receptor
Sewage
Sludge
Scenario
Agricultural
Land
Application
Surface
Disposal
Incinerator4
200
Phenol
Sediment
biota
x
Pyrene
Aquatic
community
Sediment
biota
Soil
biota
x
x
x
Silver
Aquatic
community
Aquatic
invertebrates
Fish
Adult
Child
x
x
x
x
x
4
No
chemical
with
cancer
or
non­
cancer
end­
points
failed
the
screening
assessment
from
incineration.
In
addition,
no
chemical
with
cancer
end­
points
failed
the
screening
assessment
by
either
the
land
application
or
the
surface
disposal
scenarios.

EPA
will
design
and
conduct
a
targeted
national
survey
of
pollutants
in
sewage
sludge
in
2005
through
2007.
The
results
of
the
survey
will
provide
pollutant
concentration
values
that
EPA
will
then
use
in
a
more
refined
risk
assessment
and
risk
characterization.
Based
on
the
results
of
these
refined
analyses,
EPA
will
propose
as
soon
as
practicable
new
regulations
under
Section
405(
d)
for
any
pollutants
which
it
determines
may
be
present
in
sewage
sludge
in
concentrations
which
may
adversely
affect
public
health
or
the
environment.

Academia
EPA
Log
#
51:
Ellen
Z.
Harrison
Comment
Research
It
was
not
possible
through
reading
the
April
9
document
to
evaluate
how
well
the
research
mentioned
addresses
the
NRC
recommendations
because
there
was
only
cursory
description
of
the
several
projects.
The
document
should
and
could
have
included
a
much
more
detailed
description
of
the
research
which
is
mentioned
since
conducting
additional
research
is
an
important
recommendation
of
the
NRC
report.

I
followed
up
with
EPA
and
with
U.
Arizona
to
try
to
get
a
better
understanding
of
the
projects
mentioned
in
the
April
9
document.
There
are
only
a
few,
and
they
leave
most
of
the
NRC
recommendations
unaddressed.

The
Region
8
study
proposal
was
forwarded
to
me
by
Bob
Brobst.
It
is
a
brief
proposal
dealing
with
some
soil
impacts
of
one
or
two
applications
of
a
sludge
on
range
land
experimental
plots.
After
more
than
a
month
of
trying,
I
was
able
to
get
some
information
on
the
other
EPA
project.
USEPA,
2003d
201
This
came
as
an
email
dated
May
7
from
Steve
Wright
at
ORD
forwarded
on
May
8
by
Terry
Simpson
which
described
a
possible
ORD
study
the
fate
of
indicator
bacteria
through
the
wastewater
treatment
process
and
land
application
at
an
unspecified
number
of
WWTPs.
The
email
indicated
that
the
study
is
likely
to
be
delayed
due
to
work
on
the
Pennsylvania
project
Finally
I
also
obtained
some
information
on
the
U.
Arizona
Water
Quality
Center
research
which
is
mentioned
in
the
April
9
document.
There
are
several
studies
planned
or
underway
thatinvolve
monitoring
of
air,
water
and
sludges
for
selected
pathogens
at
several
sites
around
the
US.

The
other
research
mentioned
in
the
April
9
document
is
the
Pennsylvania/
USDA/
EPA
project.
EPA
cites
the
PA
study
and
lists
objectives
that
appear
to
go
beyond
what
that
study
will
accomplish
(
p17386
CFR)
as
I
know
from
my
participation
in
the
Information
Sharing
Group
(
ISG).
I
am
very
familiar
with
that
project
since
I
have
been
participating
in
the
ISG.
I
have
reviewed
the
draft
Quality
assurance
plan
(
US
EPA,
June
2003)
twice
and
participated
in
numerous
conference
calls
and
one
face­
to­
face
meeting
involving
the
research
teams
as
well
as
ISG
participants.
This
project
is
multi­
faceted
and
complex.
However,
as
pointed
out
in
the
draft
QAPP
and
in
the
comments
on
the
draft
QAPP,
there
are
many
significant
limitations
(
see
Harrison
comments
on
draft
QAPP,
Appendix
A
to
this
document).

A
recent
email
from
John
Walker
at
EPA
to
the
ISG
participants
summarized
some
of
those
limitations.

That
this
PA
project
is
presented
as
a
center­
point
of
the
research
response
to
the
NRC
recommendations
is
of
great
concern.
It
is
not
a
health
study
nor
a
study
of
exposure
in
a
"
real
world"
setting.
As
stated
in
the
email
above,
Walker,
representing
EPA,
has
consistently
stated
that
this
limited
study
would
be
useful
in
helping
to
shape
future
needed
studies.
However,
the
April
9
document
does
not
commit
to
further
studies
and
seems
to
imply
that
this
PA
study
will
provide
the
needed
research.

Response
These
comments
have
been
responded
to
in
other
sections
of
this
document.

Citizens
EPA
Log
#
29:
Henry
J.
Staudinger
Comment
II.
EPA
Credibility
At
Issue
EPA's
strategy
must
be
considered
in
the
context
of
the
Agency's
failure
to
address
persistent
health
complaints
from
those
exposed
to
biosolids
(
not
surprising
in
light
of
the
EPA's
admission
that
public
health
protection
is
not
a
priority)
as
well
as
the
Agency's
failure
to
test,
monitor,
or
enforce
Part
503,
even
as
EPA
promoted
land
application
of
biosolids
as
its
preferred
method
of
sewage
sludge
waste
disposal.

EPA's
strategy
must
also
be
considered
in
the
context
of
the
limited
scope
of
the
NRC
study
funded
by
the
Agency
in
response
to
growing
opposition
from
an
increasingly
incredulous
public.
USEPA,
2003d
202
Instead
of
asking
NRC
to
evaluate
why
human
health
complaints
followed
exposure
to
biosolids,
EPA
asked
NRC
only
to
evaluate
EPA
methods
used
to
assess
the
risks
from
chemical
pollutants
and
pathogens
in
treated
sewage
sludge
based
on
published
literature.

EPA
was
well
aware
that
with
the
absence
of
scientific
studies,
NRC
would
be
unable
to
find
"
documented
scientific
evidence"
in
the
literature
to
answer
the
persistent
public
health
questions.
Nevertheless,
NRC
was
able
to
identify
considerable
scientific
research
needed
to
address
uncertainties
about
adverse
human
health
effects.
NRC
not
only
confirmed
that
scientific
studies
had
not
been
conducted,
but
it
also
set
forth
the
need
for
considerable
additional
scientific
research.
The
NRC
Report
stated
in
part:

"
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."
[
NRC
Report.
Emphasis
added]

After
the
Report
was
issued,
EPA
sought
to
diminish
its
negative
impact
by
quoting
out
of
context
the
above
"
no
documented
scientific
evidence"
phrase,
thereby
misleading
the
public
into
believing
that
NRC
had
found
a
scientific
basis
to
confirm
that
Part
503
protected
human
health.

EPA's
reaction
was
not
a
surprise
to
those
who
have
tried
unsuccessfully
for
a
long
time
to
focus
EPA's
attention
on
the
public
health
issues.
An
objective
EPA
would
have
admitted
that
the
limited
scope
of
the
study
it
funded
made
it
impossible
for
NRC
to
find
"
documented
scientific
evidence"
to
confirm
whether
Part
503
did
or
did
not
protect
public
health,
and
that
NRC
saw
the
need
for
scientific
studies
and
other
actions
to
address
persistent
public
health
concerns.

Instead,
EPA
opened
the
door
for
others
to
totally
misrepresent
the
Report
as
a
clean
bill
of
health,
when
nothing
could
be
further
from
the
truth.
EPA's
continued
unwillingness
to
confront
the
limitations
of
its
Part
503
makes
it
difficult
to
believe
that
EPA's
proposed
strategy
is
intended
to
adequately
address
the
human
health
issues.
EPA's
stated
strategy
reinforces
that
perception.

If
EPA
is
to
effectively
carry
out
a
strategy
to
protect
public
health
and
the
environment,
there
must
be
public
confidence
in
the
process.
The
process
should
begin
with
clear
recognition
that
the
persistent
health
complaints
make
a
compelling
case
that
Part
503
has
not
been
protective
of
public
health;
confirmation
that
there
is
no
documented
scientific
evidence
to
answer
the
important
health
and
environmental
questions;
and
commitment
to
develop
a
strategy
that
will
elicit
much
needed
scientific
information.

EPA
must
also
recognize
that
it
cannot
continue
to
ignore
the
potential
risks
until
meaningful
research
has
been
undertaken
and
completed.
The
special
risks
to
sensitive
individuals
such
as
the
immune
compromised
and
the
potential
adverse
impact
of
applying
biosolids
on
pollution
sensitive
sites
are
representative
of
those
risks.
USEPA,
2003d
203
Until
EPA
can
scientifically
document
that
the
health
and
right
to
life
of
sensitive
individuals
such
as
the
severe
immune
compromised
will
not
be
adversely
affected
by
exposure
to
biosolids,
EPA
must
prohibit
exposure
of
those
individuals
to
biosolids.
EPA
must
also
take
immediate
steps
to
make
certain
that
biosolids
are
not
applied
on
pollutions
sensitive
sites.

Response
These
comments
have
been
responded
to
in
other
sections
of
this
document.

EPA
Log
#
59:
New
Jersey
Department
of
Environmental
Protection
Comments
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.

°
As
stated,
section
405(
d)(
2)(
C)
requires
EPA
to
review
the
existing
sewage
sludge
regulations
at
least
every
two
years
for
the
purpose
of
identifying
additional
toxic
pollutants
in
sewage
sludge
and
promulgating
regulations
for
such
pollutants.
In
order
to
maintain
the
viability
and
public
acceptance
of
the
biosolids
land
application
program,
it
is
imperative
that
the
EPA
provide
staff
resources
and
funding
to
ensure
that
these
reviews
do
take
place
in
a
timely
manner.
As
is
prudent
for
any
environmental
program,
the
Department
maintains
an
ongoing
and
active
monitoring
program.
Currently,
the
Department
is
compiling
additional
data
on
radionuclides
in
biosolids
in
the
state,
and
is
willing
to
share
this
data
with
the
EPA.
In
addition,
the
Department
will
commence
a
more
extensive
sampling
and
analysis
program
for
dioxins,
dibenzofurans,
and
PCBs
(
up
to
209
congeners)
within
the
next
year,
and
has
just
received
a
grant
award
to
investigate
the
speciation
of
mercury
in
biosolids.

Response
As
described
previously,
results
of
an
inter­
Agency
analytical
survey
and
dose
modeling
for
radionuclides
in
sewage
sludge
will
be
announced
in
a
separate
Federal
Register
notice
by
the
end
of
Calendar
Year
2003.
This
is
a
separate
activity
from
the
Part
503
program.
EPA
appreciates
the
commenter's
offer
to
share
chemical
pollutant
analytical
data
with
EPA.

Environmental
Groups
EPA
Log
#
43:
Natural
Resources
Defense
Council
(
NRDC)

Comment
EPA
'
S
RESPONSE
TO
THE
NATIONAL
RESEARCH
COUNCIL
'
S
REPORT
The
National
Research
Council's
("
NRC
")
Report
on
Biosolids
Applied
to
Land
found
that
to
address
the
"
persistent
uncertainty
about
the
potential
for
adverse
human
health
effects
from
exposure
to
biosolids"
EPA
needs
to
update
the
scientific
basis
of
its
regulations
governing
land
application
of
biosolids.
The
purpose
of
doing
so
is
"
to
(
1)
ensure
that
the
chemical
and
pathogen
standards
are
supported
by
current
scientific
data
and
risk­
assessment
methods,
(
2)
demonstrate
effective
enforcement
of
the
Part
503
rule,
and
(
3)
validate
the
effectiveness
of
biosolids
management
practices."
EPA's
Response
to
the
NRC
Report
indicates
that
EPA
is
generally
satisfied
with
the
status
quo
and
makes
few
if
any
serious
commitments
to
implement
NRC's
recommendations.
In
the
face
of
a
growing
body
of
evidence
that
EPA's
regulations
are
USEPA,
2003d
204
inadequate
to
ensure
that
public
health
is
protected,
EPA
not
only
discounts
NRC's
recommendations
but
also
the
congressional
mandate
of
the
Clean
Water
Act
and
its
own
prior
commitments.

The
Clean
Water
Act
delegates
authority
to
EPA
to
establish
rules
regarding
sewage
sludge
that
are
protective
of
public
health
and
the
enviroment.
EPA
is
required
to
develop
"
management
practices
and
numerical
criteria
[
that
are
]
adequate
to
protect
public
health
and
the
environment
"
and
to
review
these
regulations
every
two
years
to
update
them
for
newly
identified
toxic
pollutants.
In
the
Summary
Response
to
the
Final
Sludge
Rule,
codified
at
40
C.
F.
R.
5
503
("
Rule
"),
EPA
expressed
confidence
that
the
Rule
would
effectively
safeguard
public
health,
but
went
on
to
state
that
"
the
Agency
is
prepared
to
move
aggressively
to
address
any
problems
with
sewage
sludge
use
should
the
evidence
warrant."
EPA
also
"
commit[
ed
]
to
develop
a
comprehensive
environmental
evaluation
and
monitoring
study
"
to
"
verify
its
conclusions
about
the
adequacy
"
of
EPA
regulatory
standards
and
"
to
aid
the
Agency
in
its
efforts
to
develop
a
comprehensive
ecological
risk
assessment
methodology."
Ten
years
later,
EPA
has
completely
failed
to
live
up
to
that
commitment.
The
evidence
overwhelmingly
warrants
that
EPA
go
beyond
the
panoply
of
current
studies
and
projects
discussed
in
its
Response
and
undertake
an
aggressive
plan
to
improve
regulation
under
the
503
Rule
to
reflect
current
scientific
understanding
of
biosolids
land
application
and
its
concomitant
human
health
and
ecological
effects.

Comments
of
Dr.
Peter
L.
deFur
The
2002
NRC
report
and
EPA's
response
The
National
Research
Council
completed
a
study
in
2002
of
the
biosolids
regulatory
program
under
CWA
section
503.
This
study
examined
specific
aspects
of
the
progress
in
managing/
regulating
beneficial
use
of
sewage
sludge,
including
the
program
to
identify
chemicals
to
add
to
the
list
of
regulated
compounds.
The
NRC
report
made
a
series
of
recommendations
to
EPA:

In
1992,
the
Ocean
Dumping
Ban
Act
prohibited
dumping
of
sewage
sludge
(
biosolids)
in
the
ocean.
As
required
by
Congress,
the
Environmental
Protection
Agency
(
EPA)
created
a
program
to
manage/
regulate
the
land
disposal
of
sewage
sludge
under
section
405(
d)
of
the
Clean
Water
Act
(
CWA)
(
CFR,
Title
40
Part
503).
In
response
to
the
Clean
Water
Act
requirement
to
reassess
periodically
the
scientific
basis
of
the
Part
503
Rule
and
to
address
public
health
concerns,
the
EPA
asked
the
National
Research
Council
(
NRC)
to
conduct
an
independent
evaluation
of
the
technical
methods
and
approaches
used
to
establish
the
chemical
and
pathogen
standards
for
biosolids,
focusing
specifically
on
human
health
protection
and
not
ecological
or
agricultural
issues.
Currently
the
law
regulates
10
inorganic
compounds:
Arsenic,
Cadmium,
Chromium,
Copper,
Lead,
Mercury,
Molybdenum,
Nickel,
Selenium,
and
Zinc;
chromium
has
been
suspended
and
molybdenum
has
only
a
ceiling
limit.
These
compounds
are
regulated
based
on
individual
risk­
based
concentration
limits.
Pathogen
standards
are
not
risk­
based
concentration
limits
for
individual
pathogens
but
are
technologically
based
requirements
aimed
at
reducing
the
presence
of
pathogens
and
potential
exposures
to
them
by
treatment
or
a
combination
of
treatment
and
use
restrictions.
USEPA,
2003d
205
The
NRC
committee
report
focused
on
identifying
how
current
risk­
assessment
practices
and
knowledge
regarding
chemicals
and
pathogens
in
biosolids
can
be
used
to
update
and
strengthen
the
scientific
basis
and
credibility
of
EPA's
biosolids
regulations.
The
first
main
issue
addressed
is
that
there
is
a
lack
of
exposure
and
health
information
on
human
populations
exposed
to
biosolids.
Thus,
the
report
contains
the
incompatible
statements
that
1)
there
is
no
documented
scientific
evidence
that
the
present
503
rule
is
not
protective,
but
2)
that
there
are
few
data
on
health
effects
of
sewage
sludge
spreading.
The
NRC
recommended
that
there
is
a
need
for
epidemiological
data;
EPA
needs
to
study
unusual
occurrences
of
disease,
and
needs
to
conduct
pre­
planned
exposure­
assessment
studies.
The
NRC
also
concluded
that
no
substantial
reassessment
has
been
done
to
determine
whether
the
chemical
or
pathogen
standards
promulgated
in
1993
are
supported
by
current
scientific
data
and
risk­
assessment
methods.
NRC
recommended
that
the
EPA
should
expand
its
biosolids
oversight
activities
to
include
procedures
for
(
1)
assessing
the
reliability
of
the
biosolids
treatment
processes,
(
2)
monitoring
compliance
with
the
chemical
and
pathogen
standards,
(
3)
conducting
environmental
hazard
surveillance,
and
(
4)
studying
human
exposure
and
health.

The
1996
NRC
report
on
related
issues
(
Use
of
Reclaimed
Wafer
and
Sludge
in
Food
Crop
Production)
questioned
the
reliability
of
the
results
of
the
1988
National
Sewage
Sludge
Survey
(
NSSS)
because
of
limitations
in
sampling
analyses
and
data
reporting
methods.
That
committee
found
no
adequate
justification
for
EPA's
decision
to
eliminate
from
regulation
all
chemicals
detected
at
less
than
5%
frequency
in
the
NSSS
(
or
10%
frequency
in
subsequent
reanalysis),
and
the
recent
report
(
NRC,
2002)
repeated
this
conclusion.
The
NSSS
and
the
1993
Rule
503
considered
14
major
exposure
pathways:
9
to
human,
2
to
animals,
2
to
soil
organisms,
and
one
to
plants.
Each
pathway
was
evaluated
independently
and
no
consideration
was
given
to
exposure
from
multiple
pathways.
In
the
latest
report,
the
NRC
(
2002)
recommended
that
the
EPA
conduct
a
new
National
Sewage
Sludge
Survey,
aggregate
exposure
assessments,
and
assess
a
reasonable
maximum
exposure
(
RME)
individual,
rather
than
an
HEI
(
highly
exposed
individual),
for
each
exposure
pathway.
Fate
and
transport
models
and
exposure
parameter
assumptions
used
in
the
risk
assessment
should
be
updated
to
reflect
the
most
current
information
on
the
RME
individual
for
each
exposure
pathway.
Represented
of
stakeholders
should
be
included
in
the
risk­
assessment
process.

New
information
on
identification
of
bacteria,
viruses,
protozoa,
and
helminthes
has
become
available
since
setting
the
standards
in
1993.
Humans
may
be
exposed
to
pathogens
in
biosolids
from
ingestion
of
contaminated
food,
water
or
soil;
dermal
contact;
and
inhalation
of
bioaerosols.
NRC
recommended
that
EPA
should
conduct
a
national
survey
of
pathogen
occurrence
in
raw
and
treated
sewage
sludge.
Quantitative
microbial
risk­
assessments
(
QMRA)
should
be
developed
and
used
to
establish
regulatory
criteria
(
treatment
requirements,
use
restrictions,
and
monitoring)
for
pathogens
in
biosolids.
NRC
also
recommended
that
the
EPA
should
foster
development
of
standardized
methods
for
measuring
pathogens
in
biosolids
and
bioaerosols.
EPA
should
also
promote
research
that
uses
improved
pathogen
detection
technology
to
better
establish
the
reliability
of
is
prescribed
pathogen
treatment
processes
and
biosolids­
use
controls
to
achieve
and
maintain
minimal
exposure
over
time.
Research
should
be
conducted
to
assess
whether
other
indicator
organisms
could
be
used
in
regulation
of
biosolids.
USEPA,
2003d
206
NRC
also
noted
limitations
in
EPA's
approach
that
are
inherent
in
the
risk
assessment
practice
of
the
time.
Some
of
these
persist
today.
NRC
noted
the
following
problems
related
to
the
risk
assessment
practices:

Inability
to
integrate
chemical
and
pathogen
risks
Failure
to
evaluate
multiple
pathway
exposures
Inability
to
evaluate
chemicals
with
no
or
limited
toxicity
data
Inability
to
evaluate
chemicals
for
which
uptake
rates/
constants
were
not
available
Weaknesses
(
and
subsequent
improvements)
in
the
analytical
procedures.

The
EPA
response
to
the
NRC
recommendations
was
less
than
full
agreement.
EPA
did
not
initiate
a
national
survey,
but
plans
to
conduct
targeted
surveys
of
sludge
with
regards
to
pathogens
and
chemical
contaminants.
These
research
efforts
may
provide
important
and
useful
data,
but
will
not
replace
the
results
from
a
well
designed
and
conducted
national
survey
(
that
does
not
have
to
be
synoptic).
Thus,
the
EPA
research
will
not
answer
the
questions
posed
about
the
extent
and
distributions
of
chemicals
and
pathogens
in
sludge
on
a
national
level.
EPA
still
needs
to
conduct
a
national
survey
of
some
sort.

EPA
states
that
the
agency
will
incorporate
new
and
revised
information
into
risk
assessments;
this
effort
will
hopefully
address
issues
raised
here
as
well.
The
problems
raised
in
the
section
on
Risk
Assessment
above
need
to
be
included
in
the
re­
evaluation.

The
agency
response
to
the
NRC
urging
for
stakeholder
involvement
is
not
yet
convincing.
NRC
has
urged
EPA
to
take
more
seriously
the
need
for
meaningful
stakeholder
participation
(
NRC,
1996),
noting
the
need
to
engage
the
public
in
national
efforts
with
long
lasting
and
widespread
impacts.
This
rule
making
is
such
an
effort.
Standard
notice
and
comment
is
not
sufficient
and
EPA
should
consider
a
series
of
national
information
hearings
and
meetings,
establish
a
federal
advisory
committee,
or
initiating
a
permanent
means
of
involving
the
public
and
affected
parties
in
sludge
rule
making.

EPA
is
to
be
commended
for
opening
new
lines
of
research
on
the
topics
suggested
by
NRC
and
other
related
items.
Unfortunately,
EPA
is
not
completely
under
control
of
this
research
effort
­
it
is
subject
to
the
shifts
of
the
sands
of
the
federal
budget.
Funding
this
effort
must
be
jointly
shared
by
the
regulated
community,
businesses
and
industries
and
even
individual
residences
that
contribute
to
the
problem.
Recipients
of
sludge
cannot
be
expected
to
pay
the
sole
or
a
large
part
of
the
burden,
but
may
be
expected
to
support
the
research
along
with
the
other
constituencies.
EPA
needs
to
be
able
to
collect
a
disposal
or
user
fee
for
sludge
and
use
those
funds
for
the
research
program,
much
as
the
permit
programs
levee
a
permit
fee
to
pay
the
costs
of
program
administration.

EPA
'
s
reliance
on
risk
assessment
(
and
NRC's
urging
of
same)
is
hindering
the
agency's
perspective
on
other
approaches.
Specifically,
the
problems
of
environmental
pathogenic
and
chemical
contamination
in
the
US
are
great
enough
to
acknowledge
that
preventing
such
contamination
is
more
cost­
effective
than
cleaning
or
controlling
contamination.
In
this
light,
USEPA,
2003d
207
pollution
prevention
offers
an
effective
means
of
dealing
with
several
issues
that
so
far
remain
difficult,
including:
chemicals
with
no
toxicity
data;
multiple
exposure
pathways;
low
level
exposure
to
many
chemicals
at
the
same
time;
simultaneous
exposure
to
pathogens
and
chemicals,
to
name
but
a
few.
This
approach
would
allow
EPA
to
treat
chemicals
and
pathogens
as
inherently
risky
and
assume
that
these
will
cause
some
harm
under
real
conditions,
requiring
data
to
the
contrary
from
relevant
interested
and
affected
parties.
EPA
can
use
existing
authority
to
undertake
pollution
prevention
measures
for
sewage
sources
and
treatment.

EPA
research
on
methods
must
include
analytical
research
tools
to
deal
with
the
difficulties
of
this
particular
matrix,
the
unknowns
and
the
sorts
of
problems
that
arose
in
the
1988
survey.
At
present,
it
is
not
clear
that
the
EPA
research
agenda
will
have
sufficient
attention
to
the
analytical
chemistry
needs.

EPA
should
continue
to
consider
the
efficacy
of
epidemiological
surveys
of
the
health
effects
of
sludge,
while
supporting
focused
health
studies
on
air,
water,
food,
and
direct
exposure
pathways.
NRC
recommended
these
and
related
epidemiological
studies,
and
EPA
should
plan
on
the
type
of
studies
described
in
NRC
(
2002).

The
response
of
EPA
to
the
NRC
charge
to
increase
and
enhance
enforcement
is
obscure
and
seems
to
say
that
the
agency
is
already
doing
what
it
is
doing.
This
reply
is
not
sufficient
and
should
provide
some
evidence
of
enforcement.
EPA
has
not
been
aggressive
on
enforcement
and
has
not
insisted
that
states
take
an
aggressive
approach
to
enforcing
CWA
provisions
generally.

Response
These
comments
have
been
responded
to
in
other
sections
of
this
document.

Municipal
Wastewater
Treatment
Plants
EPA
Log
#
19:
Metropolitan
Water
Reclamation
District
of
Greater
Chicago
Comment
In
Section
IX
on
pages
17393
and
17394,
EPA
should
present
a
clearer
accounting
of
the
status
of
the
411
pollutants
that
are
discussed.
EPA
should
present
a
table
of
all
411
compounds,
and
should
indicate
in
the
table
the
status
of
the
reevaluation
of
each
compound.
The
table
should
indicate
for
each
compound
if
there
is
(
i)
a
low
frequency
of
detection,
(
ii)
insufficient
information
to
perform
further
evaluation,
(
iii)
scientific
information
in
recent
literature
sufficient
to
identify
the
compound
as
a
pollutant
of
concern,
and
(
iv)
a
human
health
benchmark
or
benchmarks
available
in
the
scientific
literature.
This
will
enable
POTWs
and
others
to
better
assess
which
compounds
are
most
likely
to
be
considered
in
future
rulemaking.

Response
EPA
believes
the
information
contained
in
the
Summary
Response
to
this
section
gives
a
clear
accounting
of
the
human
health­
based
pollutant
selection
process
and
the
determination
whether
or
not
to
proceed
to
an
exposure
and
hazard
screening
assessment.

EPA
Log
#
24:
Hampton
Roads
Sanitation
District
(
HRSD)
USEPA,
2003d
208
Comment
Section
405(
d)(
2)(
C)
review
of
the
regulations
HRSD
approves
of
EPA's
strategy
of
reviewing
the
regulations
using
new
information
that
is
available.
The
Part
503
regulations
have
been
in
place
now
for
ten
years
and
EPA
should
have
an
extensive
database
from
the
annual
reports
that
have
been
submitted.
This
data
can
be
analyzed
for
trends
in
metals
and
pathogen
content
in
biosolids.
With
an
eye
toward
the
limited
resources
of
the
Agency,
it
would
be
prudent
to
glean
as
much
additional
information
as
possible
from
studies
that
have
already
been
initiated
across
the
nation.
However,
HRSD
strongly
urges
EPA
to
utilize
only
information
that
meets
the
Data
Quality
Act
standards.
The
original
Part
503
regulations
are
based
on
sound
science
that
was
available
at
the
time
of
promulgation.
EPA
should
not
bow
to
pressure
to
lower
their
standards
and
accept
data
that
has
not
undergone
peer
review.
For
example,
EPA
should
support
studies
that
either
quantify
or
disqualify
physical
symptoms
directly
associated
with
biosolids.
The
introduction
of
unsubstantiated
anecdotal
evidence
into
public
record
has
needlessly
caused
the
public
to
fear
land
application.
It
is
EPA's
obligation
as
a
public
agency
to
separate
the
hearsay
from
the
accurate
information
and
educate
the
public.
Remaining
silent
in
the
face
of
false
accusations
of
the
toxicity
of
biosolids
infers
that
the
public
should
be
suspicious
of
biosolids
land
application.

HRSD
supports
the
Agency's
plan
to
pursue
studies
that
better
understand
measurement,
control,
and
fate
of
pathogens
during
production
and
land
application
of
biosolids.

Response
EPA
agrees
with
the
comments
on
the
importance
of
data
quality.
In
reviewing
Part
503,
EPA
will
consider
and
evaluate
all
relevant
and
reliable
information
(
i.
e.,
information
that
can
be
verified
and
meets
EPA's
Data
Quality
Guidelines.)

EPA
Log
#
47:
Miami­
Dade
County
Water
and
Sewer
Department
(
MDWASD)

Comment
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.

The
MDWASD
concurs
with
EPA's
assessment
that
the
current
data
available
on
the
chemicals
involved
with
biosolids
do
not
indicate
the
need
for
additional
regulations
at
this
time.
We
also
agree
that
data
gaps
do
exist
and
that
these
gaps
must
be
addressed
prior
to
further
regulations.
We
are
following
several
research
projects
that
WERF
are
conducting
that
will
hopefully
help
fill
in
some
of
these
data
gaps.
One
study
that
is
of
interest
to
MDWASD
is
a
study
titled
"
A
Safety
Assessment
Tool
for
Land
Application
of
Biosolids",
which
is
being
done
by
the
WERF.
This
study
develops
a
series
of
toxicity
bioassay
tests
that
can
be
used
to
determine
the
health
hazards
and
environmental
impacts
of
biosolid
use.

Human
health
and
environmental
protection
are
paramount
concerns
at
MDWASD.
As
always,
MDWASD
is
willing
to
participate
in
research
and
studies
that
the
EPA
and
other
research
organizations
would
like
to
conduct.
USEPA,
2003d
209
Response
EPA
will
decide
whether
or
not
additional
regulations
are
needed
after
it
completes
a
more
refined
risk
assessment
and
characterization
for
the
15
pollutants
that
failed
the
screening
analysis,
as
described
in
the
Summary
Response
to
this
section.
EPA
appreciates
the
commenter's
offer
to
participate
in
research
with
EPA.

Land
Application
Company
EPA
Log
#
26:
Synagro
Technologies,
Inc.

Comment
DEFICIENCIES
IN
NAS
/
NRC
REPORT
The
NAS/
NRC
Report
is
deficient
because
it
considered
only
a
small
fraction
of
the
available
information.
Although
the
results
are
interesting
in
a
technical
risk­
assessment
or
risk
policy
context,
they
are
not
highly
relevant
to
the
practical
regulatory
process
for
biosolids.
In
particular,
the
Report
ignored:

o
Existing
data
from
scientific
literature
and
regulated
community
on
chemicals
and
pathogens.

o
Majority
of
biosolids
research
literature.

o
The
contingent
management
framework
under
which
EPA
and
the
states
currently
manage
and
regulate
the
beneficial
recycling
of
biosolids.

o
Benefits
of
biosolids
recycling.

o
The
conservative
nature
and
embedded
precautionary
approach
of
both
EPA's
original
503
Rule
risk
assessment
and
pathogen
control
measures.

The
NAS/
NRC
was
not
mandated
to
conduct
a
comprehensive
literature
review.
The
NAS/
NRC
panel's
review
of
the
scientific
literature
was
neither
comprehensive
nor
complete,
and
many
important
documents
(
including
existing
EPA
documents)
on
microbiological
risk
assessment
of
biosolids
were
completely
missed.
Examples
of
significant
documents
or
data
sources
overlooked
by
NAS/
NRC
include:

°
Water
Environment
Association
of
Ontario's
2001
Fate
and
Significance
of
Selected
Contaminants
in
Sewage
Biosolids
Applied
to
Agricultural
Land
Through
Literature
Review
and
Consultation
with
Stakeholder
Groups.

°
EPA.
1995.
Pathogen
risk
assessment
methodology
for
municipal
sludge
landfilling
and
surface
disposal.
EPA/
600/
R­
95/
016.

°
National
Biosolids
Partnership
1999.
"
503
Core
Documents".

Additionally,
the
Report
did
not
consider
on­
going
research
that
is
being
sponsored
by
the
Water
Environment
Research
Foundation
(
WERF).
Relevant
selected
projects
include:
USEPA,
2003d
210
°
A
safety
assessment
tool
for
land
application
of
biosolids
(
K.
M.
Banks,
Purdue
University).

°
Assessing
the
fate
of
emerging
pathogens
in
biosolids
(
Scott
Yates,
University
of
California).

°
A
dynamic
model
to
assess
microbial
health
risks
associated
with
beneficial
uses
of
biosolids
(
J.
Colford,
University
of
California).

Before
embarking
on
any
research
program,
it
would
be
useful
to
collect
all
the
existing
scientific
literature
and
contact
the
principal
investigators
of
projects
involving
environmental
health
and
safety
of
biosolids.
It
is
likely
that
many
of
the
questions
raised
in
the
Report
could
be
answered
by
this
action
alone
without
requiring
any
additional
field
or
laboratory
studies.

EPA
Review
of
Part
503
Regulations
Under
CWA
405(
d)(
2)(
C)
°
Generally
the
concepts
are
viable
and
should
continue.
°
EPA
needs
to
make
sure
that
its
literature
search
is
complete.
°
The
list
of
chemicals
is
reasonable
and
the
process
for
evaluating
it
is
reasonable.
°
EPA
should
at
all
times
rely
on
verified
toxicity
values.

Response
The
first
part
of
these
comments
have
been
responded
to
in
other
sections
of
this
document.
EPA
disagrees
with
the
comment
that
the
NAS/
NRC
report
is
deficient.
EPA
agrees
that
in
the
review
of
Part
503
regulations,
EPA
should
ensure
that
the
literature
search
is
complete
and
should
rely
on
verified
toxicity
values.

Association
EPA
Log
#
30:
Tri­
TAC
Comment
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.

The
process
described
by
EPA
for
conducting
its
review
under
section
405(
d)(
2)(
C)
of
the
CWA
appears
to
be
both
reasonable
and
appropriate
as
do
the
criteria
for
proceeding
to
a
screening
analysis.
Tri­
TAC
believes
that
EPA's
efforts
to
review
existing
literature
for
information
on
pollutants
that
were
not
among
the
411
originally
listed
is
a
critical
component
of
the
review
effort
given
the
recent
focus
placed
on
emerging
pollutants
such
as
polybrominated
diphenyl
ethers.
As
outlined
above,
Tri­
TAC
believes
that
new
chemicals
of
concern
should
be
further
evaluated
to
the
extent
that
the
EPA's
criteria
for
proceeding
to
a
screening
analysis
are
met.

Tri­
TAC
recommends
that
EPA
provide
a
clearer
accounting
of
the
status
of
the
pollutants
it
is
evaluating
in
its
405(
d)(
2)(
C)
review.
Specifically,
Tri­
TAC
suggests
that
EPA
make
available
a
table
detailing
information
such
as
frequency
of
detection,
sufficiency
of
data
for
performing
further
evaluation,
the
literature
source
for
the
new
information,
and
any
human
health
information
or
benchmarks
for
the
pollutant.
USEPA,
2003d
211
Response
Please
see
the
information
contained
in
the
Summary
Response
to
this
section,
which
gives
a
clear
accounting
of
the
human
health­
based
pollutant
selection
process
and
the
determination
of
whether
or
not
to
proceed
to
an
exposure
and
hazard
screening
assessment
for
particular
pollutants.

EPA
Log
#
46:
Association
of
Metropolitan
Sewerage
Agencies
(
AMSA)

Comment
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.

The
process
described
by
EPA
for
conducting
its
review
under
section
405(
d)(
2)(
C)
of
the
CWA
appears
to
be
both
reasonable
and
appropriate
as
do
the
criteria
for
proceeding
to
a
screening
analysis.
AMSA
believes
that
EPA's
efforts
to
review
existing
literature
for
information
on
pollutants
that
were
not
among
the
411
originally
listed
is
a
critical
component
of
the
review
effort
given
the
recent
focus
placed
on
emerging
pollutants
such
as
polybrominated
diphenyl
ethers.
AMSA
believes
that
new
chemicals
of
concern
should
be
further
evaluated
to
the
extent
that
the
Agency's
criteria
for
proceeding
to
a
screening
analysis
are
met.

AMSA
recommends
that
EPA
provide
a
clear
accounting
of
the
status
of
the
pollutants
it
is
evaluating
in
its
405(
d)(
2)(
C)
review.
Specifically,
AMSA
suggests
that
EPA
make
available
a
table
detailing
information
such
as
frequency
of
detection,
sufficiency
of
data
for
performing
further
evaluation,
the
literature
source
for
the
new
information,
and
any
human
health
information
or
benchmarks
for
the
pollutant.

Response
Please
see
the
EPA
response
to
Comment
Log
No.
30.

Counties
EPA
Log
#
28:
Solano
County
Department
of
Environmental
Mangement
Comment
6.
Areas
requiring
additional
research
A)
Potential
impacts
to
wildlife
and
regional
watershed
resulting
from
land
application
of
biosolids.

In
addition
to
the
response
to
the
NRC
report,
Solano
County
DEM
also
recommends
that
the
USEPA
pursue
research
to
determine
what
effects
the
localized
land
application
of
biosolids
has
on
wildlife
(
aquatic
and
dry
land)
and
the
regional
watershed
associated
with
the
application
site.

B)
Potential
bioaccumulation
of
contaminants
in
livestock.
Solano
County
DEM
also
recommends
that
the
USEPA,
in
coordination
with
the
USDA,
pursue
research
into
the
health
effects
to
livestock
and
economic
impacts
(
positive
and
negative)
associated
with
land
application
of
biosolids
on
the
farming
community.
USEPA,
2003d
212
Response
EPA,
in
its
review
of
Part
503,
has
assessed
the
potential
hazard
to
both
aquatic
and
terrestrial
ecological
receptors
(
invertebrates
and
vertebrates
animals
and
plants)
from
land
application
of
sewage
sludge.
For
additional
details,
please
see
the
Technical
Background
Document
for
today's
FR
notice.

States
EPA
Log
#
52:
Washington
State
Department
of
Ecology
Comment
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.

A
thorough
review
of
EPA's
efforts
to
comply
with
405(
d)(
2)(
C)
of
the
CWA
is
simply
beyond
my
reach
at
this
point
in
time.
It
is
evident
that
EPA
has
engaged
a
thoughtful
process
and
done
a
great
deal
of
work
toward
satisfying
this
requirement.
The
question
I
think
EPA
should
entertain
here
is
whether
it
has
or
can
incorporate
the
recommendations
of
the
NRC
that
have
bearing
in
this
regard.
It
may
not
be
possible
to
answer
all
the
NRC
recommendations
in
this
round
of
review,
but
obviously
the
closer
EPA
comes
to
doing
that,
the
more
defensible
will
be
the
final
result.

I
am
not
aware
of
information
in
our
possession
that
might
help
EPA
fill
data
gaps
of
specific
concern
although
we
would
investigate
the
availability
of
information
if
asked.
Any
such
information
would
likely
be
in
the
possession
of
individual
treatment
works.
We
presently
maintain
a
data
base
(
BDMS)
with
more
than
20,000
points
of
data
which
we
would
make
available
to
the
agency
with
certain
caveats
about
data
interpretation
and
quality.

Response
EPA
thanks
the
commenter
for
attempting
to
help
EPA
with
collecting
new
data
and
offering
to
share
data
that
they
currently
posess.

EPA
Log
#
48
and
39
(
duplicates):
Wisconsin
Department
of
Natural
Resources
Comment
II.
The
following
comment
is
in
response
to
EPA's
review
of
regulated
pollutants
under
section
405(
d)(
2)(
C)
of
the
CWA.

1.
EPA
proposes
a
reasonable
approach
to
conduct
a
refined
risk­
based
screening
analysis
to
identify
additional
pollutants
for
regulation.
However
it
should
be
noted
that
pathogens
are
not
considered
in
this
assessment
and
should
be.
Also,
special
consideration
should
be
given
to
emerging
pollutants
and
research
should
be
identified
as
necessary
to
determine
appropriate
routes
of
exposure
and
toxicity
levels.

Response
EPA
appreciates
these
comments.
The
purpose
of
this
review
was
to
identify
additional
toxic
chemicals
for
potential
regulation.
EPA
has
not
yet
sufficiently
developed
both
the
methods
for
measuring
pathogens
in
sewage
sludge
or
to
assess
their
risk
to
humans
and
the
USEPA,
2003d
213
environment.
The
Summary
Response
to
this
section
explains
to
what
extent
emerging
pollutants
were
included
in
the
screening
process.

TOPIC
K.
OTHER
Academia
EPA
Log
#
1:
Ellen
Z.
Harrison
Comment
As
I
make
my
way
through
the
EPA
response
to
the
NRC
recommendations,
I
have
some
questions
and
requests
which
I
am
sending
along
to
you.

Since
it
is
my
understanding
that
before
EPA
can
conduct
any
research,
they
must
have
an
approved
Quality
Assurance
Project
Plan
(
QAPP
­
not
exactly
sure
I
have
the
name
right),
when
EPA
research
is
mentioned
in
the
document,
I
assume
there
must
be
such
a
plan.
I
think
it
would
be
appropriate
and
useful
to
include
those
in
the
electronic
docket.

For
my
review,
I
need
to
know
what
the
EPA
studies
entail.
As
you
know,
I
am
familiar
with
the
EPA/
USDA/
PA
project
for
which
QAPP
is
not
yet
final.
However
there
are
other
EPA
studies
I
am
not
familiar
with
and
need
to
be.

On
line
524
of
the
EPA
response,
studies
being
conducted
by
Region
8are
mentioned.
I
assume
that
there
must
be
a
proposed
research
plan
and
a
QAPP
for
that
work.
Can
I
see
that
ASAP?

On
lines
530­
533
mention
is
made
of
other
EPA
studies.
What
part
of
EPA
is
doing
them?
Can
I
see
the
QAPP
ASAP?

I
may
come
across
other
such
references
as
I
make
my
way
through
the
report,
but
I'd
like
a
response
to
this
inquiry
as
soon
as
you
can
provide
it
so
I
know
what
to
expect.

Response
EPA
will
require
QAPPs
for
all
research
projects
and
studies
detailed
in
today's
final
action
plan
that
generate
data
and
information
that
potentially
will
be
used
for
determining
if
amendments
to
the
Part
503
Standards
are
warranted
in
the
future.
The
Agency's
Data
Quality
Guidelines
require
procedures
such
as
QAPPS
to
ensure
that
the
data
generated
from
these
studies
or
research
projects
meet
the
standards
of
the
Guidelines.

EPA
Log
#
2:
Ellen
Z.
Harrison
Comment
If
you
find
that
the
QAPP
are
not
public
info,
please
explain
why
not.
I
know
in
the
PA
study
we
are
assuming
that
they
are.

Response
Responded
to
above.
USEPA,
2003d
214
EPA
Log
#
5:
Ellen
Z.
Harrison
Comment
I
did
get
into
the
bibliography
document
and
search
it
and
found
that
this
reference
is
missing
­
and
I
think
it
is
important
one.

Chapron,
CD,
NA
Ballester
and
AB
Margolin.
2000.
The
detection
of
astrovirus
in
sludge
biosolids
using
an
integrated
cell
culture
nested
PCR
technique.
J.
Applied
Microbio.
89,
11­
15.

Response
EPA
thanks
the
commenter
for
bringing
this
reference
to
EPA's
attention.

EPA
Log
#
51:
Ellen
Z.
Harrison
Comment
The
bibliography
compiled
and
made
part
of
the
docket
is
helpful,
but
specific
citations
should
be
provided
in
the
response
document
where
appropriate.
For
example,
p.
17385­
6
refers
to
EPA
research
previously
conducted.
Citations
to
that
work
should
be
included.

Response
EPA
will
ensure
that
all
appropriate
citations
will
be
included
in
the
record
in
the
Office
of
Water
Docket
for
today's
Federal
Register
Notice.

Consulting
EPA
Log
#
3:
Chip
McCarty
Comment
I
finally
had
a
change
to
download
and
look
over
the
docket
materials
for
the
Agency's
response
to
the
NRC
report.

Although
you
may
get
public
comments
on
this
otherwise,
I
thought
I'd
let
you
know
of
some
typos
in
one
of
the
lists
that
probably
ought
to
be
addressed
at
some
point.

In
Document
ID
=
OW­
2003­
0006­
0020
the
human
health
benchmarks
spreadsheet
(
USEPA
2002e),
there
are
4
constituents
that
were
misspelled
or
have
other
typos.
They
are:

On
page
1
of
12:
Arochlor
1016
and
Arochlor
1254
­
Correct
spelling
is
Aroclor
­
no
"
h"

On
page
8
of
12:

Trichloro­
2­
hydroxydiphenyl
ether,
2,2,4­

CAS
number
refers
to
2,4,4'­
Trichloro­
2­
hydroxydiphenyl
ether,
not
a
"
2,2,4"
compound
which
cannot
exist
USEPA,
2003d
215
Trifluranlin
­
Correct
spelling
is
Trifluralin
(
only
one
"
n")

Response
EPA
thanks
the
commenter
for
these
corrections
which
have
been
included
in
Table
1
of
Appendix
O
of
the
Technical
Background
Document
for
today's
FR
notice.

EPA
Log
#
4:
Chip
McCarty
Comment
Thanks.
As
we
discussed
on
the
phone,
its
2,4,4'­
Trichloro­
2'­
hydroxydiphenyl
ether
I
missed
the
2'
earlier
as
I
was
cutting
and
pasting
from
the
document
into
e­
mail.

Let
me
know
if
there's
anything
else
I
can
do
to
help.

Response
EPA
thanks
the
commenter
for
this
correction.

Citizens
EPA
Log
#
15:
Shiryl
Hogue
Comment
I
am
very
concerned
about
the
biosolids
(
same
as
being
applied
in
the
fields
in
Mohave
Valley,
AZ)
that
have
been
put
on
two
lawns
in
my
neighborhood.
Biosolids
have
been
used
across
the
street
at
8222
Aspen
Dr.,
Mohave
Valley,
AZ
and
at
Evergreen
&
Pecan
St.
I
have
just
learned
that
the
pest
control
company
and
their
employee,
who
is
used
by
ten
households
in
this
area
was
not
notified
that
biosolids
were
used
in
these
two
yards,
and
were
walked
through
while
spraying
and
then
carried
into
others
homes.
As
this
was
done
approximately
a
year
ago,
there
has
been
numerous
people
continually
sick,
flies,
and
odor.
I
would
like
to
know
if
this
was
done
within
EPA
regulations.

Response
As
stated
in
the
Summary
Response
on
the
Human
Health
Studies
section
of
this
document,
EPA
is
not
responding
to
local
incidents
of
human
health
impacts
from
the
land
application
of
sewage
sludge
since
EPA
personnel
have
generally
not
been
involved
in
the
investigation
of
these
specific
local
incidents.
However,
it
is
these
types
of
local
situations
that
will
be
investigated
using
new
protocols
to
be
developed
for
incidents
reporting.
Furthermore,
EPA
Regions
and
States
have
the
responsibility
to
address
situations
where
compliance
assistance
and
enforcement
actions
to
address
biosolids
are
appropriate
and
necessary.
Regional
responsibilities
for
the
biosolids
program
include
actively
following
up
on
phone
calls
and
complaints
received
from
the
public,
and,
where
appropriate
as
demonstrated
by
the
data,
initiating
Agency
enforcement
actions.
EPA
has
taken
enforcement
actions
and/
or
appropriate
administrative
remedies
to
address
biosolids
violations
of
40
CFR
part
503
and
will
continue
to
take
such
actions,
including
instances
where
biosolids
pose
an
imminent
and
substantial
endangerment
to
human
health
or
the
environment.

EPA
Log
#
16:
Inese
Holte
USEPA,
2003d
216
Comment
As
a
rural
resident,
I
was
concerned
that
the
land
application
of
sludge
was
a
great
way
to
get
rid
of
hazardous
waste.
The
rural
residents
are
immediately
affected
by
groundwater
contamination
and
the
effects
of
odors
and
air
borne
pathogens.
New
studies
show
that
plants
take
up
metals.
Consequently,
it
is
not
just
the
rural
residents
at
risk.
There
are
80,000
chemicals
in
use
with
no
idea
of
the
health
effects
of
most
of
them
(
and
this
is
not
even
considering
how
these
chemicals
combine
into
new
formations
in
sludge).
There
are
medications
in
sludge,
metals,
pathogens
from
homes
and
hospitals,
radioactive
materials,
and
thousands
of
unknown
chemicals.
The
land
application
of
sludge
defies
logic.
Soil
is
a
living
organism
and
if
we
destroy
it
with
sludge,
how
will
we
grow
food?
Just
watch
what
people
put
down
the
drain.
Then
think
of
all
the
illegal
things
that
business
and
industries
put
down
the
drain.
Then
look
at
all
of
the
loopholes
in
the
EPA
regulations
and
laws
such
as
RCRA.
Then
ask
yourself­
who
is
watching
and
regulating
anything
about
sludge
from
what
goes
into
it,
to
where
it
is
applied
,
and
how
it
is
applied?

Response
The
fact
that
there
is
a
very
large
number
of
chemicals
in
use
does
not
mean
that
these
chemicals
will
necessarily
end
up
in
sewage
sludge
in
concentrations
that
may
adversely
effect
human
health
or
the
environment.
EPA
is
not
attempting
to
address
all
chemicals
that
may
be
found
in
sewage
sludge
but,
in
today's
FR
notice,
EPA
has
identified
a
number
of
priority
chemicals
in
sewage
sludge
that
will
be
further
evaluated
for
potential
regulation.
Specific
comments
(
e.
g.,
odors)
have
been
responded
to
in
other
sections
of
this
document
or
are
addressed
in
today's
FR
notice
(
e.
g.,
see
Project
4
in
today's
FR
notice
to
characterize
odor
compounds
and
determine
if
current
sludge
management
techniques
are
appropriate).

EPA
Log
#
9:
Roseann
Weinrich
Comment
Greetings.
I
am
writing
to
comment
on
the
503
Rule.
I
agree
wholeheartedly
with
everything
the
Sierra
Club
posted,
but
I
would
like
to
add
a
few
things
about
our
local
problem
here
in
Schuylkill
County,
Pennsylvania.
It
seems
that
taxpayers
are
no
longer
allowed
to
speak
freely
or
to
disagree
with
the
powers
that
be
regarding
the
land
disposal
of
sewage
sludge.
As
president
of
the
Mahanoy
Creek
Watershed
Association,
our
group
has
become
the
victim
of
harassment
from
our
county
conservation
district
because
of
our
strong
opposition
to
biosolids.
We
have
even
received
a
letter
from
the
manager
encouraging
us
to
"
disband,
regroup,
or
rename
and
rededicate"
our
group's
priority
to
"
mine
remediation."
Our
watershed
association
has
dedicated
itself
to
the
remediation
of
past
mining
insults
and
to
the
prevention
of
future
problems.
We
are
opposed
to
the
dumping
of
240
wet
tons
of
class
b
sludge
to
reclaim
mine
lands.
We
have
been
told
that
any
leachate
will
remain
in
the
mine
pool
and
will
not
affect
our
groundwater.
If
you
know
anything
about
the
history
of
Anthracite
mining,
there
was
no
exact
mapping
science
in
place
at
the
time
and
nobody
knows
where
the
mine
pool
water
flows.
However,
there
is
a
stripping
pit
in
Excelsior,
PA,
that
the
residents
would
like
to
have
drained
because
four
people
have
drowned
in
it,
but
the
PA
DEP
District
Mining
Office
in
Pottsville
will
not
drain
it
because
they
don't
know
where
the
water
will
go.
How
can
this
be
when
the
PA
DEP
insists
that
the
mine
pool
water
will
not
communicate
with
groundwater
in
sludged
areas?

We
have
been
told
by
the
conservation
district
that
our
group's
position
has
put
the
other
watershed
organizations
at
risk
because
now
all
associations
are
seen
as
"
potential
adversarial
USEPA,
2003d
217
groups
composed
of
environmental
activists
who
do
not
believe
in
proven
historical
research."
What
they
fail
to
admit
is
that
the
"
proven
historical
research"
has
been
funded
by
the
EPA,
the
DEP,
the
WEF
and
the
sludge
industry.
The
most
recent
firing
of
Dr.
David
Lewis
adds
verification
that
nobody
is
interested
in
the
TRUTH.

Certain
employees
in
the
PA
DEP
have
been
working
very
closely
with
the
sludge
industry
in
promoting
land
disposal
of
sewage
sludge.
In
a
paper
titled
"
Two
Decades
of
Mine
Reclamation:
Lessons
learned
from
one
of
the
nation's
largest
biosolids
beneficial
use
programs,"
William
E.
Toffey
(
Philadelphia
Water
Department,
Biosolids
Utilization
Manager),
Charles
R.
Miller
(
Wheelabrator
Water
Technoligies,
Bio
Gro
Divisions)
and
L.
Douglas
Saylor,
Bureau
of
District
Mining
Operations,
PA
DEP,
state
"
In
reflecting
on
the
loss
of
soil
and
habitat
resources
as
a
consequence
of
mining,
the
genuine
environmental
concern
ought
not
be
how
to
better
regulate
use
of
biosolids
in
land
reclamation,
but
instead
how
to
ensure
the
greatest
possible
volume
is
applied
to
mined
lands."
Apparently,
this
is
about
dumping,
not
reclamation.
Minutes
of
the
Biosolids
Technical
Workgroup
(
held
at
the
Rachel
Carson
State
Office
Building
in
Harrisburg)
were
posted
on
the
DEP
website.
It
is
apparent
that
the
regulatory
agencies
are
working
with
the
sludge
industry,
spending
tax
dollars
to
misinform
the
public
about
the
beneficial
use
of
the
toxic
slurry
of
hazardous
waste
that
the
sludge
industry
has
conveniently
renamed
"
biosolids."

We
feel
that
the
current
503
rule
is
based
upon
outdated
science
and
is
not
protective
of
the
public
health
and
ask
that
you
act
immediately
to
prevent
any
further
damage
from
being
done.
Time
is
not
on
our
side.

Response:
Please
see
the
Summary
Response
on
the
Human
Health
Studies
section
of
this
document
and
the
response
to
Log
No.
15
in
this
section
of
the
document.

EPA
Log
#
17:
Maine
Sludge
Alliance
Comment
The
Maine
Sludge
Alliance
quotes
the
following
from
the
NAC/
NRC
REPORT
BIOSOLIDS
APPLIED
TO
LAND:
ADVANCING
STANDARDS
AND
PRACTICES
that
show
the
Data
Gaps:

1)
"
EVALUATION
OF
EPA's
APPROACH
TO
SETTING
CHEMICAL
STANDARDS"
(
Page
177)
Some
pollutants
and
exposure
pathways
were
eliminated
in
the
screening
processes
and
risk
assessments
when
chemical­
specific
data
were
insufficient
to
perform
pathway­
specific
calculations
or
when
toxicity
data
were
insufficient
for
a
given
pollutant.
For
example,
a
plant
uptake
factor
for
lindane
was
not
available,
so
no
assessments
were
conducted
for
any
pathway
that
relied
on
that
factor.
The
technical
support
documents
for
EPA's
Round
1
and
Round
2
assessments
do
not
provide
a
list
of
data
gaps,
nor
do
they
specify
the
chemicals
and
pathways
that
were
eliminated
from
consideration
because
of
data
gaps.
Lack
of
information
does
not
equate
to
lack
of
risk.
THEREFORE,
DATA
GAPS
SHOULD
NOT
BE
USED
AS
CRITERION
FOR
ELIMINATING
CHEMICALS
FROM
CONSIDERATION
BUT
USED
TO
IDENTIFY
IMPORTANT
AREAS
FOR
FUTURE
RESEARCH.
USEPA,
2003d
218
2)
"
ADVANCES
IN
RISK
ASSESSMENTS"
(
Page
156)
Of
particular
note
are
updates
to
the
risk­
assessment
framework
recommended
by
the
NRC,
the
Presidential/
Congressional
Commission
on
Risk
Assessment,
and
various
EPA
offices.
The
risk­
assessment
methods
and
policies
practiced
and
advocated
at
EPA
have
changed
significantly,
although
not
at
the
pace
recommended
by
the
NRC
and
the
risk
commission.
As
a
result,
the
Part
503
rule,
which
has
not
been
modified
to
account
for
any
new
methods
and
policies,
is
now
inconsistent
with
current
NRC
recommendations
and
EPA
policies
within
various
offices.

3)
"
EVALUATION
OF
EPA's
APPROACH
TO
SETTING
PATHOGEN
STANDARDS"
(
Page
304)
Because
there
are
no
requirements
for
on­
site
monitoring
of
pathogens,
there
is
little
information
available
to
evaluate
the
reliability
of
use
restrictions
in
achieving
their
intended
minimum
exposure
levels
or
to
verify
that
those
desired
levels
are
maintained
over
an
extended
time.
The
committee
found
that
some
potential
exposure
pathways
were
not
sufficiently
considered
when
the
use
restrictions
were
developed.
For
example,
potential
off­
site
inhalation
of
dust
and
aerosols
does
not
appear
to
have
been
considered.
The
potential
for
groundwater
contamination
by
pathogens
was
not
sufficiently
addressed.
In
addition,
the
potential
for
runoff
to
contaminate
surface
waters
was
not
adequately
addressed.

4)
"
INTEGRATION
OF
CHEMICAL
AND
PATHOGEN
RISK
ASSESSMENT"
(
Page
331
and
332)
The
committee
found
that
although
the
chemical­
specific
risk
assessments
conducted
to
establish
Part
503
regulations
can
be
improved
by
using
new
risk­
assessment
methodology,
the
remaining
uncertainty
for
complex
mixtures
of
chemicals
and
biological
agents
is
sufficient
to
preclude
the
development
of
risk­
management
procedures
that
can
reliably
result
in
acceptable
levels
of
risk.
In
reviewing
these
methods,
the
committee
found
that
there
are
inherent
differences
between
chemical
and
pathogenic
agents
that
must
be
considered
in
single­
agent
risk
assessments.
In
particular,
infection
of
an
individual
from
exposure
to
pathogens
in
biosolids
might
result
in
secondary
infections
in
others.
The
secondary
infections
might
be
caused
by
person­
to­
person
contact
or
transmission
of
the
pathogen
to
others
through
air,
food,
or
water.

Overarching
Findings
(
Page
4)
To
assure
the
public
and
to
protect
public
health,
there
is
a
critical
need
to
update
the
scientific
basis
of
the
rule
to
(
1)
ensure
that
the
chemical
and
pathogen
standards
are
supported
by
current
scientific
data
and
risk
­
assessment
methods,
(
2)
demonstrate
effective
enforcement
of
the
Part
503
rule,
and
(
3)
validate
the
effectiveness
of
biosolids­
management
practices.

Overarching
Recommendations
(
Page
4)
*
Use
improved
risk­
assessment
methods
to
better
establish
standards
for
chemicals
and
pathogens.
*
Conduct
a
new
national
survey
of
chemicals
and
pathogens
in
sewage
sludge.
*
Establish
a
framework
for
an
approach
to
implement
human
health
investigations.
USEPA,
2003d
219
Response
Please
see
Section
VII
"
Final
Action
Plan
to
Address
NRC
Recommendations"
in
today's
FR
notice.
As
stated
in
this
section
"
The
Agency
does
not
have
sufficient
resources
to
implement
all
of
the
NRC
recommendations.
Therefore,
EPA
has
developed
this
final
action
plan
in
response
to
the
NRC
recommendations
with
consideration
of
public
comments
on
the
April
9,
2003
preliminary
strategy,
information
gathered
from
broad
stakeholder
input
received
through
the
WERF
Research
Summit,
and
Agency
priorities
and
resource
availability."
In
the
time
since
the
NRC
issued
its
report
in
2002,
EPA
has
taken
steps
to
enhance
its
sewage
sludge
program
and
to
begin
implementing
recommendations
by
the
NRC.
Specifically,
Projects
1
to
14
in
today's
FR
were
designed
to
address
the
most
important
NRC
recommendations.

EPA
Log
#
11:
Loudon
Neighbors
Against
Toxic
Sludge
(
NATS)

Comment
In
December
2001,
the
nation's
largest
environmental
organization,
the
Sierra
Club,
announced
its
opposition
to
the
land
application
of
sewage
sludges
because
the
current
policies
do
not
protect
human
health
and
the
environment.
On
May
21,
2003,
the
Sierra
Club
condemned
EPA's
totally
inadequate
response
to
the
recurring
criticism
of
weak
science
behind
the
Sludge
Rule.
(
See
Public
Comment
at
www.
epa.
gov/
docket
OW­
2003­
0006.)
The
National
Farmers
Union
(
with
over
300,000
members)
declared
at
its
March
3,
2003,
Convention
its
opposition
to
land
application
of
sewage
sludge
for
similar
reasons.

Last
year,
both
the
National
Research
Council
and
the
EPA
Office
of
Inspector
General
released
studies
that
warned
that
the
current
land
application
rules
are
not
based
on
recent
and
sound
science
and
that
there
is
an
"
urgent
need
for
health
studies
among
rural
populations
exposed
to
sludge."
EPA's
own
Inspector
General
said
in
a
Memorandum
dated
September
6,
2002,
to
Christine
Todd
Whitman:
"
EPA
does
not
know
whether
current
regulations,
when
adhered
to,
are
protective
of
public
health "
Because
of
this
lack
of
credible
science,
EPA
is
using
unsuspecting
and
unwilling
populations
as
human
experiments,
exposing
them
to
interactions
of
pathogens
and
toxins
that
have
never
been
previously
considered
much
less
studied.

Yet
EPA's
Office
of
Water
has
consistently
collaborated
with
the
sludge
industry
to
debunk
any
criticism
of
its
sludge
rule.
It
routinely
gives
grants
to
sludge
trade
groups
in
order
to
"
breakdown
public
resistance
to
sludge
spreading."
Most
disturbing,
it
has
harassed
and
tried
to
silence
any
critics,
including
one
of
its
own
scientists,
Dr.
David
L.
Lewis,
who
have
raised
legitimate
questions
about
the
safety
of
current
EPA
sludge
policies.
EPA
just
recently
forced
Dr.
Lewis
out
of
his
job
because
he
published
concerns
about
the
current
EPA
sludge
rule
and
the
quality
of
science
at
EPA.
His
termination
threatens
the
foundations
of
freedom
of
speech
and
will
discourage
other
EPA
scientists
from
voicing
their
concerns
about
other
EPA
policies
that
are
not
based
on
sound
science.
Even
now
the
EPA's
response
to
the
withering
criticism
of
its
Sludge
Rule
is
to
defend
the
Rule
and
propose
cosmetic
and
contrived
studies
to
vindicate
its
position.

Severe
health
consequences
alleged
from
exposure
to
sludge
have
resulted
in
lawsuits.
One
wrongful
death
case
was
settled
in
2002
with
the
defendants
insisting
on
sealing
the
settlement
amount.
A
second
wrongful
death
case
was
filed
a
few
months
ago.
There
are
two
other
major
USEPA,
2003d
220
health­
related
sludge
lawsuits
filed
recently.
One
is
filed
in
Tennessee
by
Danny
Jones
against
Erwin
Utilities.
The
conservator
for
Michael
Seth
Jones,
an
extremely
sick
young
man,
is
suing
farmers,
a
municipal
utility,
and
the
manager
of
the
Water
and
Wastewater
Treatment
Plant.
Plaintiff
alleges
wrongful
acts,
conduct,
and
breaches
of
common
law
and
statutory
duties
amounting
to
negligence,
public
nuisance
and
product
liability.
The
second
health­
related
suit
was
filed
in
Florida
by
Earth
Justice
on
behalf
of
17
Desoto
County
Florida
residents
who
allege
health
problems
from
exposure
to
sludge.
Plaintiffs
are
suing
two
sludge
companies
and
five
ranchers.
Plaintiffs
also
allege
trespassing
because
sludge
fowls
the
air,
water,
reduces
property
values,
and
is
a
public
nuisance.

Loudoun
NATS,
a
civic
group,
requests
that
EPA
reinstate
Dr.
David
Lewis,
who
is
the
kind
of
scientist
EPA
needs
to
have
any
credibility
with
the
public,
so
he
can
continue
his
valuable
service
to
the
citizens
of
the
United
States.
Unless
sludge
research
is
based
on
sound
science
and
it
can
clearly
be
demonstrated
that
this
contaminated
and
often
hazardous
material
will
be
disposed
of
in
such
a
way
that
it
does
not
pose
a
threat
to
public
health,
there
will
continue
to
be
more
sludge
victims,
like
Daniel
Pennock,
Michael
Seth
Jones,
and
the
17
Florida
plaintiffs.

Response
Please
see
response
to
Log
No.
15
in
this
section
of
the
document.
The
case
of
Dr.
David
Lewis
is
not
related
to
EPA's
request
for
comments
on
the
April
9,
2003
Federal
Register
Notice.

EPA
Log
#
13:
Clarence
Williams
Comment
A
recent
situation
developed
in
Cumberland
County,
VA,
re
the
proposed
topical
application
of
sludges
on
a
hay
field.
I
was
asked
by
the
local
residents
of
their
community
to
become
involved.
After
an
analysis
of
the
situation,
I
found
the
following
facts
to
apply:

1.
No
sign
was
erected
on
Spillman
Road
as
stipulated
in
the
county's
ordinance;
requirement
is
at
least
30
day
notice
prior
to
application.
There
was
no
local
enforcement
of
this
ordinance
article.
2.
The
same
sludge
site
had
been
applied
in
1999.
Community
residents
experienced
lack
of
assistance
at
that
time
and
experienced
discomforts
from
odor
problems.
3.
The
proposed
sludge
application
was
scheduled
for
March,
2003,
application
would
vary
from
2
to
15
dry
tons
per
acre.
One
notice
sign
was
erected
on
Jamestown
Road,
embedded
in
grass
and
bushes,
but
no
sign
exposed
to
Spillman
Road.
4.
An
appeal
was
made
to
the
VDH
Commissioner
for
a
health
"
variance"
(
increase
in
the
buffer
zone)
from
the
standard
200
feet
from
an
occupied
dwelling.
Though
the
drinking
water
wells
are
60+
feet
from
home
front
and
homes
were
less
than
200
feet
from
sludge
application
site
property
line,
the
request
was
denied
by
the
Commissioner.
Basis
for
denial
was
that
community
citizens
do
not
qualify,
though
tax
payers
to
the
Commonwealth,
for
a
"
variance";
only
industry
qualifies.
5.
An
appeal
was
made
to
the
VDH
Piedmont
Director
to
furnish
an
analysis
of
the
sludges
and
to
recommend
a
"
medically"
determined
"
safe"
buffer
zone
for
the
community
residents.
Both
requests
were
denied.
These
denials
were
after:
A.
knowing
there
were
residents
with
respiratory
illnesses
and
on
prescribed
medication.
B.
knowing
that
no
effort
was
made
by
VDH
to
contact
all
16
homes
within
a
one­
mile
strip.
C.
knowing
that
a
community
resident
had
received
a
note
of
USEPA,
2003d
221
sludge­
exposure
warning
from
her
physician.
Later
independent
investigation
shows
more
residents
with
immune
suppression
and
physician's
warning
of
health
deterioration
with
sludge
exposure.
6.
An
appeal
was
made
to
the
Virginia
Board
of
Health.
During
the
requested
session,
members
were
told,
by
VDH
officials,
that
the
Applicator
or
sludge­
landowner
are
the
only
ones
that
can
grant
a
buffer
zone
since
the
site
has
already
received
a
State
permit.
However,
the
official
said
that
the
VDH
may
"
request"
that
the
Application
"
consider"
the
community
residents'
request.
7.
During
a
subsequent
independent
investigation,
it
was
found
that
one
community
resident
had
planned
for
a
year
to
have
a
family
reunion
at
her
home
with
approximately
150
relatives
coming
mostly
from
out
of
state.
Since
the
health
of
out
of
state
relatives
can
not
be
known
nor
what
effect
sludges
may
have
on
their
health,
another
appeal
was
made
to
the
Virginia
Board
of
Health.
8.
Apparently
consideration
was
given
to
the
fact
that
out
of
state
Courts
may
not
be
sympathetic,
should
a
sickness
be
proven
relative
to
sludges'
content.
Again,
the
Applicator
has
yet
to
provide
any
disclosure
of
the
proposed
sludge
content.
9.
A
letter
dated
5­
30­
03,
states
that
the
Applicator
has
removed
the
field
site
6A
from
the
permit
but
intends
to
apply
sludges
in
the
fall
of
2003.
The
remaining
fields'
proximity
will
also
subject
the
community
residents
to
any
possible
sludge
content
harm.
No
one
can
predict
that
an
out
break
of
illness
will
or
will
not
occur.
Several
sludge­
related
illness
out
breaks
have
been
alleged
in
Virginia.
Without
a
full
content
disclosure,
no
statement
of
fact
pro
or
con
is
relevant.
10.
It
is
noted
that
in
Cumberland
County,
the
Applicator
applies
sludges
from
NY
and
transports
via
rail.
The
concerns
of
harmful
pathogen
regrowth
is
present
and
real.
It
is
also
noted
that
the
Applicator
has
applied
sludges
within
the
County,
on
March
19,
2003,
that
had
an
odor
for
two
(
2)
miles
within
the
community.
A
local
applicator
representative
refuses
to
apply
any
additional
lime
as
soil
pH
is
at
8+.
11.
The
Applicator
is
a
member
of
the
Virginia
Biosolids
Use
Regulation
Advisory
Committee
and
should
be
held
to
a
higher
standard.
However,
the
Applicator
has
not
given
a
date
for
the
future
proposed
application.
This
leaves
the
local
county
monitor
and
community
residents
in
a
quandary
as
to
community
activities
and/
or
seeking
preventative
health
remedies;
in
other
words
the
community
is
being
held
hostage
to
the
whim
of
an
Applicator
and
supported
by
the
Virginia
Department
of
Health's
Biosolids
Use
Regulations.
The
Virginia
Department
of
Health
is
a
promoter
of
sludge­
land
application
as
well
as
a
regulator,
as
described
in
their
sludge­
promotional
booklet.
12.
Should
there
be
an
interest
in
this
situation,
all
documents
can
be
furnished
to
qualified
officials
or
made
public
to
the
Citizenry.

Response
Please
see
response
to
Log
No.
15
in
this
section.

EPA
Log
#
20:
Gary
O.
Schaefer
Comment
If
the
EPA
thinks
people
are
not
getting
sick,
having
illnesses,
and
dying
from
sludge,
you
must
have
your
heads
buried
in
the
sand
or
sludge.
Scientists
at
the
University
of
Georgia
have
documented
links
to
sludge
and
sickness,
as
has
Helaine
Shields
of
New
Hampshire
(
sludgevictims.
net)
on
a
computer
site.
Even
your
own
Inspector
General
has
concluded
that
the
USEPA,
2003d
222
EPA
does
not
know
whether
the
current
rules
protect
public
health
and
that
basic
research
has
not
been
done.

Speaking
of
research,
you
do
not
need
the
research
of
hand
picked
sludge
supporting
scientists.
The
research
needs
to
be
accomplished
by
independent
scientists
who
have
no
ties
to
the
sludge
industry,
EPA
Office
of
Water,
or
any
EPA
personnel
that
are
promoting
sludge
policies
under
the
current
rules.
I
think
using
impartial
scientists
is
required
and
done
everywhere
in
the
EPA
except
the
Office
of
Water.
EPA
should
promote
freedom
of
science.
It
should
encourage
scientists
to
constructively
criticize
bad
policies
rather
than
firing
them,.
i.
e.
Dr.
David
Lewis.

No
taxpayers
money
should
be
spent
to
promote
the
use
of
dangerous
material
such
as
sewage
sludge.
Dollars
should
be
spent
looking
into
health
complaints,
deaths,
rewriting
40CFR503,
and
finding
other
ways
to
dispose
of
sewage
sludge.
The
promotion
of
sewage
sludge
by
those
who
regulate
its
use
is
an
abomination
in
my
opinion.

Speaking
of
Rule
503,
it
is
a
poorly
written
document.
The
whole
document
needs
to
be
rewritten
where
it
will
stand
up
to
legal
scrutiny.
Mr.
Mike
Hom
of
Region
4
has
told
me
that
the
way
503
is
written
nobody
can
be
held
responsible
for
illegally
grazing
cattle
before
the
30
day
restriction.
His
legal
advisers
at
Region
4
could
not
find
anyone
to
legally
blame.
Something
is
dreadfully
wrong
here.
Also,
unless
someone
from
the
EPA
personally
sees
a
violation,
nothing
can
be
done
about
it.
Is
this
to
protect
the
guilty?
Whoever
was
responsible
for
writing
503
did
so
in
the
best
interest
of
the
sludgers.
All
modifications
to
503
have
also
been
in
the
best
interests
of
sludgers.
503
needs
to
be
rewritten
where
it
is
not
"
sludge
magic
".
Presently,
it
in
no
way
protects
those
who
live
around
sludged
fields.
Go
out
and
talk
to
these
people
if
you
don
'
t
believe
it.
I
think
you
will
find
the
vast
majority
have
health
concerns
and
grievances
against
the
odors
generated
by
sludge.

Another
area
of
Rule
503
that
needs
to
be
looked
at
real
hard
is
the
lack
of
restrictions
on
applying
sewage
sludge
on
land
that
slopes
to
other
people
'
s
property
and
protected
waters.
It
is
not
right
that
this
miasma
of
pathogens,
chemicals,
toxic
metals,
dioxins
and
furans
be
allowed
to
run
off
into
areas
where
they
are
not
wanted.

Finally,
there
have
been
several
procedures
developed
to
dispose
of
sludge
without
land
applying
it.
Maybe
the
EPA
should
look
into
including
these
procedures
into
Rule
503.
I
guess
that
will
be
down
the
road
a
few
years
as
it
will
be
a
couple
of
years
before
anything
comes
out
of
this
docket,
and
you
can
all
ready
guess
who
will
benefit
from
the
modifications.

Response
EPA
is
aware
of
several
reports
attributing
adverse
health
effects
to
exposure
to
land
applied
sewage
sludge.
However,
a
causal
association
between
sewage
sludge
exposures
and
adverse
health
outcomes
has
not
been
documented
(
NRC,
2002,
p.
5).
EPA
disagrees
with
the
commenter
that
EPA's
research
program
is
biased
and
is
promoting
sewage
sludge
application
to
land
without
proper
scientific
considerations.
Regulations
established
by
EPA
contain
proper
safeguards
and
the
Agency
maintains
that
the
land
application
of
sewage
sludge
in
compliance
with
EPA's
regulations
is
an
appropriate
choice
for
communities.
USEPA,
2003d
223
EPA
Log
#
22:
Barbara
L.
Rubin
Comment
Stakeholder
Participation
and
Local
Control
of
Sludge
Spreading
a
Sham
Serious
health
concerns
have
been
raised
in
connection
with
sludge
exposure.
The
recommendations
of
the
National
Research
Council,
as
well
as
EPA's
response
to
these
recommendations,
emphasize
that
stakeholders
(
sludge
victims,
neighbors
to
sludged
sites)
should
be
involved
in
regulating
this
controversial
practice
"
because
local
jurisdictions
will
have
better
knowledge
of
local
conditions,
and
are
in
a
better
position
to
establish
additional
(
protective)
management
practices.
.
."
(
Federal
Register
page
17391).

However,
in
real
life,
stakeholder
participation
is
repeatedly
thwarted
by
a
powerful
coalition
of
state
and
federal
agencies
and
the
sludge
industry.
Citizens
who
voice
concerns
about
the
hazards
of
sludge
spreading
face
an
entrenched
industry
with
tremendous
resources
(
1).
Counties
that
want
to
promulgate
stricter
sludge
rules
have
been
threatened
by
the
industry
with
lawsuits
(
2).

Even
when
public
hearings
are
held
they
are
not
held
for
the
purpose
of
getting
public
input
but
to
promote
the
beneficial
use
of
sludge.
These
meetings
are
usually
tightly
controlled
by
the
same
coalition
of
state
agencies,
EPA
supported
trade
groups,
and
the
sludge
industry
in
order
to
prevent
the
public
from
getting
honest
answers
to
their
science­
based
concerns.

The
Virginia
Department
of
Health
Biosolids
Use
Regulations
(
VDHBUR)
clearly
state
that
the
Board
must
"...
establish
a
date
for
a
public
meeting
to
discuss
technical
issues
relating
to
the
proposal."
As
well,
proponents
of
Chapter
681,
the
recently
passed
Virginia
sludge
law,
assured
citizens
there
would
be
opportunity
for
citizen
comment
on
the
permits.
On
June
16,
the
Virginia
Department
of
Health
did
hold
a
sludge
"
meeting
to
discuss
issues
in
relation
to
the
permit
reissuance
applications"
for
Synagro
Mid­
Atlantic,
Inc.
on
6,600
acres
in
Loudoun
County.
However,
they
held
the
meeting
in
the
far
western
part
of
the
county
at
6:
30
pm,
making
it
difficult
for
stakeholders
to
attend.
It
was
easy
to
miss
the
official
announcement.
Although
the
notice
for
the
June
16
meeting
expressly
states
it
was
a
"
public
meeting",
no
opportunity
for
public
discussion
or
comment
was
allowed.
Only
industry/
government
got
to
advocate
their
position
to
captive
citizens.
The
"
meeting"
consisted
of
tables
set
up
so
citizens
could
pick
up
what
I
view
as
pure
industry
propaganda,
ask
questions
of
an
industry
or
health
department
representative,
or
watch
a
sludge
promotion
video.
It
was
clearly
planned
to
suppress
expression
of
any
dissent
on
this
highly
controversial
subject
and
muzzle
Constitutionally
guaranteed
rights
to
present
information.
Interpreting
"
meeting"
in
such
a
restrictive
way
is
only
the
beginning
of
the
denial
of
rights
the
Virginia
sludge
laws
hold
for
citizens.

The
result
is
the
state
agency
to
which
regulatory
power
is
delegated
promotes
the
sludge
it
is
charged
with
policing.
Worse,
at
the
time
of
this
"
public
meeting,"
Synagro's
representative
later
acknowledged
that
Synagro
had
not
even
submitted
the
current
updated
"
pertinent
details"
(
required
by
VDHBUR),
no
information
or
map
of
sites
existed
to
discuss,
so
even
if
the
public
had
been
granted
time
to
ask
questions
they
would
have
been
unable
to
do
so
in
the
absence
of
any
specific
details.
USEPA,
2003d
224
When
you
consider
the
preceding
example
of
industry/
government
denial
of
citizen's
rights,
in
combination
with
other
prior
actions,
you
begin
to
see
a
frightening
picture
emerge.
Other
egregious
abuses
aimed
at
those
critical
of
sludge
spreading
include:

1)
David
Lewis,
an
EPA
award­
winning
scientist
was
recently
forced
out
of
the
EPA
in
retaliation
for
publishing
research
critical
of
sewage
sludge.
Now
that
they
have
silenced
the
opposition,
EPA/
industry
is
shunning
independent
research
and
funding
sludge­
friendly
scientists.
Worse,
after
seeing
how
EPA
and
industry
collaborated
to
try
everything
to
destroy
Dr.
Lewis's
reputation
and
career,
to
cut
off
his
funds,
and
all
the
other
obstacles
they
put
in
his
way
when
he
tried
to
engage
in
and
publish
research,
no
scientist
in
his
right
mind
is
going
to
want
research
sludge
and
face
the
same
ordeal.

2)
The
House
Committee
on
Science
held
hearings
in
March
of
2000
to
review
charges
that
EPA
was
"
overly
antagonistic"
towards
scientists
and
activists
critical
of
sludge.
At
that
hearing
house
members
said
that
good
science
has
to
be
based
on
open
debate
and
not
stifling
public
and
scientific
input.

3)
EPA
has
also
spent
taxpayer
money
on
sludge
promotion
rather
than
on
sludge
safety.
In
other
words
EPA
(
with
the
help
of
the
industry
they
are
charged
to
regulate)
actively
promotes
the
very
practice
they
supposedly
oversee.
EPA
went
so
far
as
to
develop
a
"
debunking"
campaign
to
attack
and
discredit
victims
instead
of
evaluating
their
concerns.

4)
My
county
is
a
microcosm
of
these
issues.
Just
recently
scientists
supportive
of
sludge,
were
invited
to
give
presentations
and
do
research,
while
a
group
of
independent
scientists
were
excluded
from
participation
by
the
Health
Department
charged
to
protect
citizens
health.

All
of
this
adds
up
to
an
affront
to
freedom
of
science,
freedom
of
speech,
protection
of
public
health
and
the
environment,
and
democracy.

Response
EPA
is
committed
to
improving
stakeholders'
participation
in
the
sewage
sludge
program
(
Please
see
Project
14
"
Improve
Stakeholder
Involvement
and
Risk
Communication"
in
today's
FR
notice).
The
case
of
Dr.
David
Lewis
is
not
related
to
the
Agency's
request
for
comments
on
the
April
9,
2003
FR
notice.

EPA
Log
#
23:
Helane
Shields
Comment
OW­
2003­
0006­
0042
and
OW­
2003­
0006­
0043
were
not
printed
in
their
entirety
and
the
identify
of
the
writers
was
not
included.

Response
These
errors
have
been
corrected.

EPA
Log
#
31:
David
L.
Lewis
Comment
Parting
comments
USEPA,
2003d
225
Three
years
ago,
I
spoke
at
a
technical
session
sponsored
by
the
Water
Environment
Federation
and
chaired
by
Robert
O'Dette
of
Synagro
(
WEFTEC
2000
Workshop.
October
14­
15,
2000.
Anaheim,
CA).
I
urged
the
EPA,
WEF,
Synagro
and
others
to
develop
and,
as
best
as
possible,
enforce
an
anti­
retaliation,
anti­
discrimination
policy
regarding
scientists
and
members
of
the
public
who
report
problems
with
land
application
of
sewage
sludge.
I
felt
strongly
that
such
a
measure
is
in
everyone's
best
interest,
and,
in
fact
is
a
prerequisite
to
moving
forward
together.
Time
has
shown
that,
perhaps,
my
words
were
spoken
in
vain.

Protecting
academic
freedom
and
free
speech
and
providing
a
forum
for
open
debate,
in
my
opinion,
is
more
important
than
resolving
the
scientific
and
public
health
issues
themselves.
When
the
EPA,
WEF,
WERF,
and
Synagro
use
their
great
resources
and
talents
to
impose
their
will
through
fear
and
intimidation,
they
forfeit
their
integrity.
Integrity
in
the
eyes
of
the
public,
the
free
press,
and
academic
institutions
is
not
something
that
is
easily
restored
or
soon
rebuilt.
Usually,
it
can
only
be
regained
by
replacing
those
responsible
for
its
loss
with
a
new
generation
of
men
and
women
whose
priorities
and
sights
are
more
firmly
set
on
those
principles
and
virtues
to
which
every
truly
great
and
lasting
institution
aspires.

It
is
still
my
hope,
and
the
hope
of
many,
that
those
who
lead
the
EPA
and
the
institutions
and
organizations
with
which
it
associates
itself
will
take
stock
of
what
has
happened,
and
is
happening,
and
then
demonstrate
to
everyone
the
kind
of
high­
quality
leadership
and
wisdom
upon
which
all
of
us
can
build
our
future.

Response
These
comments
are
not
related
to
EPA's
request
for
comments
in
the
April
9,
2003
Federal
Register
Notice.

EPA
Log
#
33:
Citizens
for
Sludge­
Free
Land
(
CSFL)

Comment
Synagro
Technologies
Inc.
states
that
sludges
meeting
the
current
land
application
regulations
(
the
503s)
are
"
organic
fertilizers."
This
is
not
an
accurate
statement.
The
Federal
Clean
Water
Act
defines
sewage
sludge
as
a
pollutant.
Sewage
treatment
plants
were
never
designed
to
produce
fertilizers.
They
were
designed
to
remove
contaminants
from
the
wastewater.
Many
of
the
removed
pollutants
concentrate
in
the
resulting
sludge.
Sludge
researcher
Rob
Hale
warns
that
"
few
matrices
are
as
pollutant
rich
as
sewage
sludges."
Synagro's
use
of
the
term
"
organic"
is
also
misleading.
The
national
standards
for
certified
organic
foods,
prohibit
the
use
of
sewage
sludge
to
grow
certified
organic
produce.

Synagro
Technologies
Inc.
states
that
the
July
2002
NRC
report
on
Land
Application
"
gives
land
application
of
sludge
a
clean
bill
of
health."
To
the
contrary,
the
NRC
study
was
requested
because
of
growing
anecdotal
and
scientific
evidence
that
linked
some
land
application
practices
to
serious
adverse
health
effects
and
deaths.
The
NRC
panel
chair
announced
in
his
July
press
release,
that
there
is
an
urgent
need
for
health
studies
of
rural
populations
exposed
to
sludge.
The
NRC
report
concluded
that
the
science
and
risk
assessment
behind
the
503s
are
outdated,
implying
that
the
503s,
most
likely,
are
not
protective
of
human
health.
USEPA,
2003d
226
Synagro
Technologies
Inc.
argues
that
local
management
restrictions
that
go
beyond
the
503
standards
will
provide
adequate
protection
of
public
health.
However,
Synagro
Technologies
fails
to
point
out
that
it
often
challenges,
threatens
to
sue,
or
sues
communities
that
plan
to
promulgate
additional
protective
local
ordinances.

Synagro
Technologies
Inc.
prefers
to
rely
on
voluntary
best
management
practices
and
guidelines,
rather
than
on
regulations.
However,
at
many
land
application
sites,
best
management
practices
and
guidelines
are
not
followed
because
they
are
not
legally
binding.

Despite
a
massive,
ongoing
EPA/
industry
funded
public
relations
campaign
to
change
the
public's
negative
perception
of
land
application,
many
farmers
are
increasingly
shying
away
from
sludge
use.
They
apparently
believe
that
the
potential
harm
(
soil
degradation,
groundwater
pollution,
adverse
health
effects)
far
outweighs
the
alleged
benefits
(
cost
savings,
yield
increases).
Actually,
yield
increases
from
sludge
use
can
often
be
attributed
to
the
water
content
of
sludges.
And
repeated
sludging
of
the
same
site
can
seriously
degrade
soil
and
reduce
yields.

At
their
March
2003
Annual
Convention,
the
delegates
of
the
National
Farmers
Union
enacted
a
112­
page
policy.
On
page
64
the
policy
states:

The
current
practices
of
disposing
hazardous
wastes
in
existing
landfills
and
surface
mine
sites,
spreading
hazardous
wastes
and
Class
B
biosolids
on
land
surfaces,
and
injecting
hazardous
wastes
in
deep­
well
sites
should
be
discontinued.
Alternative
disposal
sites
should
be
identified
which
eliminate
the
risk
of
surface
and
groundwater
contamination,
protect
the
health
and
safety
of
citizens,
and
protect
the
soil
and
water
of
agricultural
lands,
from
which
the
nation's
food
is
produced.

Response
EPA
thanks
the
commenter
for
the
views
and
information
provided
which
EPA
will
consider
in
its
planned
activities
to
more
actively
involve
stakeholders
in
its
sewage
sludge
program.

EPA
Log
#
32:
National
Sludge
Allinace
(
NSA)

Comment
Help
for
Sewage
Victims
has
followed
the
Science
behind
the
part
503
since
1989.

How
is
it
that
EPA
has
forgotten
that
there
were
21
carcinogen
agents
in
sludge
in
1989?

How
is
it
that
EPA
has
forgotten
there
were
25
families
of
pathogens
in
sludge
in
1989?

How
is
it
that
the
Australia
and
Canadian
governments,
as
well
as
others,
recognize
that
organic
sludge
dust
is
toxic
and
will
cause
lung
diseases
­­
and
EPA
doesn't?

How
is
it
that
part
503.9(
t)
says
that
exposure
the
pollutants
is
sludge
could
kill
or
cause
serious
illness
and
your
scientist
say
sludge
is
safe?
USEPA,
2003d
227
I
have
taken
the
liberty
to
include
the
National
Sludge
Alliance
Fact
Sheet
139
which
documents
what
EPA
should
already
know
about
the
dangers
from
sludge.

Biosolids
is
a
potential
killer.

Response
These
comments
are
not
responsive
to
EPA's
request
for
comments
on
the
April
9,
2003
Federal
Register
Notice.

EPA
Log
#
49:
The
Resource
Institute
for
Low
Entropy
Systems
Comment
General
Comments
The
land
application
of
sewage
sludge
is
a
controversial
practice.
Some
people
say
sludge
is
poison.
The
Environmental
Protection
Agency
(
EPA),
which
is
responsible
under
Section
405
of
the
Clean
Water
Act
(
CWA)
to
set
regulations
for
sewage
sludge
use
or
disposal,
says
that
it
is
safe.
Since
1993,
when
the
EPA
promulgated
the
Standards
for
the
Use
or
Disposal
of
Sewage
Sludge,
its
official
policy
has
been
to
promote
the
land
application
sludge.
Every
year,
at
least
60%
of
the
estimated
6
million
dry
tons
of
sludge
produced
by
sewage
treatment
plants
goes
on
land.

There
has
recently
been
a
legal
case
in
which
the
claim
of
harm
done
by
the
land
application
of
sewage
sludge
has
been
litigated
through
to
judgment
by
a
court
in
the
United
States.
Specifically,
on
June
24,
2003
a
court
in
Georgia
ruled
that
the
land
application
of
sewage
sludge
was
responsible
for
destroying
the
fourth
generation,
Boyce
family
farm's
dairy
herd
and
damaging
farm
property.
Boyceland
Diary
of
Burke
County,
Georgia,
sued
the
city
of
Augusta
over
claims
that
toxic
metals
from
the
city's
sewage
sludge
poisoned
their
cattle
and
land.
There
was
no
evidence
that
the
land
application
of
sewage
sludge
on
the
Boyce
farm
was
out
of
compliance
with
EPA's
1993
rules
for
the
practice
of
land
applying
sewage
sludge.
Significant
anecdotal
evidence
also
indicates
that
the
land
application
of
sewage
sludge,
both
before
and
after
the
EPA
began
regulating
the
practice
in
1999,
has
caused
public
health
and
environmental
harm.

Sewage
sludge
is
the
product
of
municipal
wastewater
treatment.
Often
thought
to
consist
of
only
"
human
waste,"
sewage
sludge
in
fact
contains
organic,
inorganic,
and
biological
pollutants
from
commercial,
industrial,
and
household
wastes,
and
compounds
added
to
and
formed
during
treatment
processes.

What
is
in
sludge
and
the
public
health
effects
of
exposing
people
to
it
were
the
topics
of
a
November
2001
conference
at
the
Boston
University
School
of
Public
Health.
The
conference,
"
Sewage
Sludge
on
Land:
Public
Health
and
Environment
Impacts,"
was
sponsored
by
the
Boston
University
School
of
Public
Health;
the
Greater
Boston
Physicians
for
Social
Responsibility;
Tufts
Medical
School,
Department
of
Community
Health;
and
the
Department
of
Environmental
Health
at
the
Boston
University
School
of
Public
Health.

A
special
issue
of
the
peer­
reviewed
journal,
New
Solutions:
A
Journal
of
Environmental
and
Occupational
Health
Policy,
Volume
12,
Number
4
 
2002,
examines
many
of
the
themes
USEPA,
2003d
228
presented
at
the
sludge
conference
in
Boston,
with
a
look
at
the
health
impact
of
the
land
application
of
sewage
sludge
and
the
EPA's
policy
promoting
it.

In
the
journal,
Abby
Rockefeller
argues
that,
"
sludge
is 
a
hazardous
waste,
and
it
is
at
once
unmonitorable,
unregulatable,
and
irremediable,"
and
that
since
sewage
and
sewage
treatment
result
in
the
production
of
sludge
we
must
turn
to
on­
site
systems
and
away
from
sewers
and
sewage
treatment.

The
EPA
coined
the
word
"
biosolids"
for
sewage
sludge
that
has
been
treated
to
meet
its
regulatory
requirements
for
land
applicat
ion.
Sheldon
Rampton
asks
why
changing
the
name
of
sludge
is
so
important
to
the
EPA
and
why
the
extraordinary
effort
to
propagate
a
euphemism.
In
his
article,
he
explores
the
propaganda
model
of
communication
vs.
the
dialogic
approach,
and
how
the
propaganda
model
embraced
by
the
EPA
and
the
waste
management
industry
is
impacting
the
discussion
about
sludge's
safety.

Ted
Schettler's
article
is
about
the
precautionary
principle
and
its
application
to
sewers
and
sewage
sludge.
The
Clean
Water
Act
states
that
pollution
limits
have
to
be
established
by
risk
analysis.
But
risk
assessment,
Schettler
argues,
is
incapable
of
addressing
the
uncertainties
and
complexities
of
sewage
sludge.

Laura
Orlando
interviews
Hugh
Kaufman,
a
32­
year
veteran
of
the
EPA,
about
the
role
of
citizen
activism
in
the
effort
to
change
EPA's
sewage
sludge
policy.
This
short
piece
is
followed
by
reports
from
people
who
say
they
or
their
friends
or
families
were
made
sick
by
exposure
to
sewage
sludge.
Helane
Shields,
a
volunteer
sludge
researcher
from
New
Hampshire,
excerpted
the
list
from
a
much
longer
survey
of
sludge
victims
she
has
documented.

The
EPA
looked
at
411
pollutants
in
sludge
before
deciding
on
regulations
that
govern
9
metals
and
nothing
more.
When
synthetic
organic
chemicals
were
considered
for
regulation
in
1993,
EPA's
risk
assessments
concluded
that
they
do
not
pose
significant
risks
and
so
need
not
be
regulated.
Robert
Hale
and
Mark
LaGuardia
ask
if
the
risks
associated
with
the
presence
of
synthetic
organic
compounds
in
land
applied
sewage
sludges
have
been
adequately
assessed.
In
studies
conducted
by
the
two
researchers,
high
concentrations
of
polybrominated
diphenyl
ethers,
a
chemical
used
in
flame
retardants
and
related
to
PCBs
and
polybrominated
biphenyls,
and
nonylphenols,
a
product
of
the
degradation
during
wastewater
treatment
of
surfactants
used
in
detergents,
were
detected
in
sewage
sludge.
If
both
chemicals
were
regulated,
it
could
significantly
curtail
the
land
applications
of
sludge.

Ellen
Harrison
investigates
allegations
of
adverse
health
effects
from
sludge
exposure
and
explores
federal
and
state
authorities'
response
to
them.
Her
article
reveals
significant
weak
points
in
the
EPA
sludge
rules
and
concludes
with
a
call
for
the
end
of
the
use
of
Class
B
sludges
on
land.

David
Lewis
looks
at
the
interaction
of
pathogens
and
irritant
chemicals
in
land
applied
sewage
sludge.
His
research
into
self­
reported
illnesses
among
residents
living
near
land
application
sites
USEPA,
2003d
229
indicates
a
pattern
of
chemical
irritation
from
exposure
to
dusts
and
other
airborne
contaminants
followed
by
bacterial
infections
of
the
skin
and
respiratory
tract.
Affected
residents
appear
to
be
at
particularly
high
risk
of
infection
with
Staphylococcus
aureus,
a
pathogen
that
tends
to
invade
irritated
or
inflamed
tissue.
He
reports
that
the
prevalence
of
S.
aureus
infections
was
approximately
twenty­
five
times
higher
than
infections
among
hospital
patients,
a
recognized
risk
group
for
this
pathogen.
Dr.
Lewis
gives
credence
to
the
claims
of
self­
reporting
sludge
victims
that
it
is
sludge
that
adversely
affected
their
health.

Lennart
Hardell,
a
researcher
from
the
Department
of
Oncology
at
the
Örebro
Medical
Center
Hospital
in
Sweden,
was
unable
to
attend
the
conference,
but
submitted
a
previously
published
article
from
a
scientific
journal
[
9].
His
study
suggested
an
increased
risk
of
non­
Hodgkin's
lymphoma
with
exposure
to
polybrominated
diphenyl
ether
(
PBDE),
a
chemical
found
in
sewage
sludge.

This
issue
of
New
Solutions
ends
with
an
article
by
Joel
Tickner
and
Sara
Wright
that
argues
for
a
pollution
prevention
strategy
for
controlling
sewage
sludge
contamination.

Response
EPA
thank
the
commenter
for
relaying
the
views
and
information
provided
by
the
participants
at
this
conference.

EPA
Log
#
41:
Anonymous
Comment
YOU
MAY
BE
AN
EPA
OFFICE
OF
WATER
BUREAUCRAT,
OR
A
POTW
BOARD
MEMBER,
OR
A
SLUDGE
HAULER
IF:
1.
YOU
DON'T
LIVE
NEXT
TO
SEWAGE
SLUDGED
FIELDS.
2.
YOUR
KIDS
DON'T
HAVE
BREATHING
PROBLEMS.
3.
YOU
DON
'
T
HAVE
SLUDGE
RUN­
OFF
ON
YOUR
PROPERTY
FROM
THE
LAND
NEXT
DOOR.
4.
YOU
DON
'
T
HAVE
TO
CANCEL
FAMILY
PICNICS
IN
YOUR
BACK
YARD
BECAUSE
OF
THE
STENCH
COMING
FROM
SEWAGE
SLUDGE
NEXT
DOOR.
5.
NOBODY
IN
YOUR
NEIGHBORHOOD
HAS
DIED
O
F
STAPH
INFECTION.
6.
YOU
SUPPORT
USING
SEWAGE
SLUDGE
IN
RURAL
COMMUNITIES
WHERE
THEY
CAN
NOT
FIGHT
GOVERNMENTAL
REGULATION.
7.
YOU
FIGHT
TO
TERMINATE
ANY
SCIENTIST
WHO
WILL
NOT
KOWTOW
TO
YOUR
UNSCIENTIFIC
"
SLUDGE
MAGIC
",
AS
IN
THE
CASE
OF
DR.
DAVID
LEWIS.
8.
YOU
SUPPORT
THE
USE
OF
MILLIONS
OF
TAXPAYER'S
DOLLARS
FOR
THE
PROMOTION
OF
SLUDGE,
AND
SPEND
NOTHING
TO
INVESTIGATE
ILLNESSES
ATTRIBUTED
TO
SEWAGE
SLUDGE.
9.
INSTEAD
OF
TRYING
TO
SOLVE
SLUDGE
PROBLEMS,
YOU
LOOK
FOR
MORE
WAYS
TO
PROMOTE
SLUDGE
USE.
10.
WHEN
SELECTING
SCIENTISTS
TO
INVESTIGATE
SLUDGE
PROBLEMS,
YOU
SELECT
SCIENTISTS
WHO
ARE
KNOWN
SLUDGE
ADVOCATES
AND
HAVE
MADE
A
DECENT
LIVING
GIVING
ANSWERS
TO
SUPPORT
THE
USE
OF
SEWAGE
SLUDGE.
USEPA,
2003d
230
11.
YOUR
DOG
AND
THE
WILD
ANIMALS
LIVING
AROUND
YOU
STILL
HAVE
ALL
THE
HAIR
ON
THEIR
BODIES.
12.
YOU
HAVE
MADE
THREATS
AGAINST
PEOPLE
WHO
FIGHT
THE
USE
OF
SLUDGE.
13.
YOU
HAD
ANYTHING
TO
DO
WITH
WRITING
4OCFR503.
14.
YOU
STRETCH
OUT
ANY
CHANGES
TO
503
AS
LONG
AS
POSSIBLE
TO
INSURE
SLUDGE
IS
CONTINUED
TO
BE
DUMPED,
AND
THE
CHANGES
ONLY
FACILITATE
THE
DUMPING.
15.
YOU
HAVE
NOT
BEEN
RUN
INDOORS
BY
THE
OVERWHELMING
STENCH
EMANATING
FROM
SLUDGE
FERTILIZED
FIELDS
NEARBY
YOUR
HOME.
16.
YOU
HAVE
NOT
HAD
TO
ENDURE
EXTREME
TEMPERATURES
IN
YOUR
NON­
AIR
CONDITIONED
HOME
TO
GET
AWAY
FROM
THE
STENCH
OF
SLUDGE.
I7.
YOUR
INTEREST
IS
ONLY
IN
THE
DOLLARS
GENERATED
BY
SEWAGE
SLUDGE
USED
AS
A
FERTILIZER,
AND
NOT
IN
THE
HEALTH
OR
WELFARE
OF
THOSE
LIVING
NEAR
THE
SLUDGE
SPRAYED
FIELDS.
18.
THE
CANCER
RATE
IN
YOUR
HOUSING
AREA
IS
NOT
20%
ABOVE
THE
NATIONAL
AVERAGE.
19.
YOU
DO
NOT
RESPECT
THE
CONSTITUTIONAL
RIGHT
OF
AMERICAN
ClT1ZENS
FOR
LIFE,
LIBERTY,
AND
THE
PURSUIT
OF
HAPPINESS
ON
THEIR
OWN
PROPERTY.

Response
EPA
does
take
seriously
the
concerns
that
the
commenter
has
on
the
land
application
of
sewage
sludge.
Today's
final
action
plan
will
help
to
address
these
concerns.

EPA
Log
#
40:
Thomas
F.
Albert
Comment
Comment
#
1:
The
first
sentence
in
section
Von
page
17383
is
MISLEADING.
The
EPA
sentence
is
misleading
because
it
only
includes
part
of
the
NRC
statement
(
see
NRC
report,
page
4)
as
a
quotation
while
not
treating
the
rest
of
the
NRC
statement
as
a
quotation.

On
page
17383
(
section
V)
EPA
uses
quotation
marks
to
identify
words
from
page
4
of
the
NRC
report,
"
there
is
no
documented
scientific
evidence
to
indicate
that
the
part
503
rule
has
failed
to
protect
human
health."
EPA
on
page
17383
in
their
same
sentence
uses
NRC
wording
(
NRC
report,
page
4)
but
does
not
use
quotation
marks
and
does
not
indicate
that
the
words
are
from
the
next
sentence
on
page
4
of
the
NRC
report.
By
using
the
NRC
words,
but
not
as
a
quotation
and
by
not
starting
that
they
are
from
the
NRC
report,
EPA
fails
to
give
them
due
weight
and
thereby
MISLEADS
the
reader.

If
EPA
is
going
to
use
part
of
the
NRC
statement
it
should
use
the
entire
NRC
statement
so
as
to
not
mislead
the
reader
of
EPA's
comments.

The
correct
wording
(
as
appears
on
page
4
of
the
NRC
report)
is
as
follows,
"
There
is
no
documented
scientific
evidence
that
the
Part
503
rule
has
failed
to
protect
public
health.
However,
additional
scientific
work
is
needed
to
reduce
persistent
uncertainty
about
the
potential
far
adverse
human
health
effects
from
exposure
to
biosolids."
USEPA,
2003d
231
Response
EPA
agrees
with
the
commenter.
The
full
NRC
text
of
this
sentence
is
quoted
in
today's
FR
notice.

EPA
Log
#
25:
Northumberland
Association
for
Progressive
Stewardship
(
NAPS)
Sewage
Sludge
Study
Group
Comment
These
public
comments
are
on
behalf
of
the
NAPS
Sewage
Sludge
Study
Group.
The
Study
Group,
made
up
of
a
medical
doctor,
a
toxicologist,
two
geo­
scientists,
and
several
engineers,
was
formed
in
2000
to
study
the
land
application
of
sewage
sludge
in
Northumberland
County.
Our
review
of
sludge­
related
literature,
news
accounts,
etc.
lead
us
to
the
conclusion
that
sludge
should
not
be
land
applied
in
our
County
because
of
the
lack
of
research
concerning
the
contents
of
sludge
imported
to
Virginia
from
Pennsylvania,
New
York,
New
Jersey,
Maryland
and
the
District
of
Columbia,
as
well
as
that
generated
in
Virginia.
This
uncertainty,
when
combined
with
the
close
proximity
of
our
farms
to
numerous
waterways
leading
to
the
Potomac
River
and
directly
to
the
Chesapeake
Bay,
along
with
the
large
number
of
residents
living
adjacent
to
the
farms,
many
of
whom
depend
on
potable
water
from
shallow
wells,
caused
great
concern.
We
also
found
that
the
Virginia
Department
of
Health
had
issued
sludge
application
permits
for
farms
immediately
adjacent
to
our
County
Elementary
and
Middle
Schools
and
that
no
effort
was
being
made
to
identify
people
with
immune
deficiency
disorders
and
bronchial
problems
living
near
land
application
fields.
We
brought
these
concerns
to
the
attention
of
our
local
government
and,
following
the
2000
elections
when
the
only
member
of
our
Board
of
Supervisors
who
favored
land
application
was
defeated,
we
have
experienced
unanimous
opposition
by
the
Board
to
land
application.
However,
over
the
past
several
years,
the
sludge
industry
has
been
successful
in
lobbying
the
Virginia
State
Government
to
retain
authority
over
land
application
at
the
State
level
under
the
Dillon
Rule.
Protective
actions
that
may
be
taken
by
local
governments
are
still
being
decided
in
courtrooms
across
Virginia.
And
so,
since
the
State
insists
on
authorizing
land
application,
we
have
worked
diligently
at
the
State
level
with
the
General
Assembly
and
Board
of
Health
to
strengthen
Virginia's
land
application
ordinances
and
regulations.
W
e
we
have
had
some
success,
represented
by
passage
of
a
Virginia
Senate
bill
containing
some
restrictions
and
limited
local
authority,
our
hopes
have
been
in
the
EPA
accepting
its
responsibility
under
the
Clean
Water
Act
for
conducting
the
necessary
research
to
identify
the
levels
of
pollutants
in
treated
sewage
sludge
and
to
develop
standards
for
risk
assessment.

We
were
encouraged
when
we
reviewed
the
reports
on
land
application
by
the
EPA's
own
Office
of
Inspector
General
and
the
National
Research
Council.
We
fully
expected
that
EPA
would
respond
to
these
reports
in
a
very
positive
way.
Needless
to
say,
we
are
deeply
disappointed.

Response
In
today's
FR
notice
and
in
response
to
comments
received,
EPA
has
substantially
revised
its
action
plan
to
be
responsive,
within
the
limitations
of
available
resources,
to
the
NRC
recommendations.

EPA
Log
#
42:
National
Sludge
Alliance
(
NSA)
USEPA,
2003d
232
Comment
These
comments
are
made
on
behalf
of
the
National
Sludge
Alliance
(
NSA)
formed
in
1996
to
work
on
both
and
national
level
to
prevent
all
land
application
of
sewage
sludge
and
sludge
by­
products.
The
mission
of
the
National
Sludge
Alliance
is
to
help
protect
public
health
and
the
environment
from
the
adverse
effects
of
sewage
sludge.
The
policies
of
this
mission
include:
preventing
the
land
application
of
all
sludge;
promoting
sewer
avoidance;
and
advocating
that
industrial
wastes
be
treated
at
their
source,
not
discharged
into
publicly
owned
treatment
works
(
POTWs).

The
National
Sludge
Alliance
members
firmly
assert
that
sludge
is
an
unpredictable
hazardous
waste
and
should
always
be
treated
as
a
pollutant.
The
variable
array
of
toxic
chemicals,
pathogens,
heavy
metals,
pharmaceuticals
and
radioactive
wastes
cannot
be
used
on
land
"
beneficially".
Land
spreading
of
sludge
is
equal
to
dumping
unregulated
toxic
waste
in
our
communities.
It
contaminates
our
life
support
systems
our
water,
air,
land,
and
food
supply.
Sludge
can
and
has
poisoned
people
and
the
environment.

Land
spreading
of
sludge
is
about
power
and
politics.
It
is
about
the
transfer
of
liability
for
the
pollutants
by
using
the
POTW
drain.
The
transfer
is
from
the
polluter
via
the
drain
that
belongs
to
the
public
and
then
onto
the
farmer
or
mine
owner
and
then
on
to
the
public.
It
is
not
about
science
or
fertilizers.
Increasing
concern
among
scientists
about
the
disposal
of
sludge
on
land
supports
the
NSA
position
that
no
level
of
treatment
or
process
can
make
sludge
safe
to
use.
In
fact
the
National
Academy
of
Science
'
s
(
NAS)
recent
Committee
report
on
toxicants,
states
that
it
is
impossible
to
do
a
risk
assessment
to
prove
sludge
use
under
part
503
is
safe.
The
scientific
statement
is
very
blunt:
FINDINGS,"­­­­­
the
remaining
uncertainty
for
complex
mixtures
of
chemical
and
biological
agents
is
sufficient
to
preclude
the
development
of
risk­
management
procedures
that
can
reliability
result
in
acceptable
levels
of
risk."
The
National
Sludge
Alliance
will
continue
to
call
for
Congress
to
end
the
land
spreading
of
all
sludge
and
to
hold
EPA
accountable
for
failing
to
safely
regulate
the
management
of
this
toxic
waste.

Response
EPA
disagrees
with
the
commenter
that
sewage
sludge
"...
is
an
unpredictable
hazardous
waste
and
should
always
be
treated
as
a
pollutant."
EPA
maintains
that
the
land
application
of
sewage
sludge
in
compliance
with
EPA's
regulations
is
an
appropriate
choice
for
communities.

EPA
Log
#
57:
Tanya
Bond
Comment
The
Clean
Water
Act
should
indulge
"
no
sludge
dumping
in
the
flood
plain
of
a
river
system."
Horse
Creek
in
Desoto
Co.,
Florida
just
had
a
record
flood
(
18'
­
6'
over
12'
flood).
This
record
flood
sent
18"
of
flood
water
into
my
home.
I
live
in
the
flood
plain
of
Horse
Creek.
Desoto
Co.
receives
56,000
tons
of
sludge
every
year
­
most
is
dumped
in
the
flood
plains
of
Horse,
Prairie
Shell
Creeks
and
Peace
River.
That
sludge
ended
up
in
my
house
on
everything
down.
STOP
dumping
sludge
in
the
flood
plain!
STOP
dumping
when
ground
is
saturated
when
it's
raining.
START
TODAY,
REGULATE
A/
AA
SLUDGE.
Not
enough
regulators
and
enforcers.
No
one
but
us
is
watching
"
AWS"
DUMP,
DUMP,
DUMP,
in
the
flood
plain.
STOP
DUMPING
IN
THE
FLOOD
PLAIN!
SEE
MY
SLUDGE
STATEMENT
FOR
MORE.
USEPA,
2003d
233
Response
Please
see
the
Summary
Response
on
the
Human
Health
Studies
section
of
this
document.

EPA
Log
#
58:
Tanya
Bond
Comment
Enclosed
find
my
statement
on
Land
Application
of
Sludge
in
Desoto
Co.
No
sludge
dumping
in
the
flood
plain
(
it's
against
the
Clean
Water
Act!).
Start
regulating
A/
AA.
Enforce
the
rule
now
­
EPA
is
the
foot
dragger
­
get
busy
and
clean
up
sludge.
I
live
in
the
flood
plain,
when
Horse
Creek
floods,
all
the
sludge
(
56,000
tons)
RUNS
OFF!

Response
As
stated
previously,
EPA
will
not
respond
to
local
complaints
or
local
issues
on
specific
sewage
sludge
land
application
projects
in
this
document.
The
explanation
for
this
policy
is
contained
in
the
Summary
Response
on
the
Human
Health
Studies
section
of
this
document.

EPA
Log
#
??
(
EDKT
#
102):
Helane
Shields
Comment
EPA
must
immediately
stop
its
collaboration
with
the
sludge
industry
and
their
trade
groups.
It
must
stop
spending
tax
payer
money
to
promote
land
application.
It
must
stop
silencing
scientists
and
members
of
the
public
who
are
expressing
science­
based
concerns
about
this
controversial
practice.

Unless
there
are
radical
changes
in
EPA's
policies
and
personnel,
there
will
be
more
sludge
victims,
more
damage
to
the
environment,
more
public
resistance
to
sludge
spreading,
and
the
whole
land
application
program
will
be
doomed.

Response
EPA
disagrees
with
the
commenter
and
will
continue
to
collaborate
with
a
vast
array
of
stakeholders
to
improve
its
sewage
sludge
program.
These
stakeholders
include
industry,
academia
and
environmental
groups.

Environmental
Groups
EPA
Log
#
7:
Sierra
Club
Comment
The
Sierra
Club
is
appalled
that
EPA
is
involuntarily
terminating
Dr.
David
Lewis,
the
lead
scientist
investigating
this
latest
development
(
17),
a
32­
year
veteran
research
microbiologist,
whose
research
has
been
published
by
Nature,
Lancet,
and
other
prestigious
international
scientific
and
medical
journals.
The
sole
reason
for
the
termination
is
that
the
researcher
has
criticized
EPA's
sewage
sludge
policies
in
scientific
articles
(
4,5,
18).

Response
The
case
of
Dr.
David
Lewis
is
not
related
to
EPA's
request
for
comments
on
the
April
9,
2003
Federal
Register
notice.

EPA
Log
#
43:
Natural
Resources
Defense
Council
USEPA,
2003d
234
Comment
NRDC
appreciates
the
opportunity
to
provide
its
views
on
EPA
'
s
preliminary
decision
not
to
regulate
additional
toxic
pollutants
in
sewage
sludge
and
its
response
to
the
National
Research
Council
report
on
biosolids
applied
to
land
contained
in
Sections
I
and
I1
below,
respectively.
Attached
are
the
comments
of
Dr.
David
O.
Carpenter,
Director
of
the
Institute
for
Health
and
the
Environment
at
the
University
of
Albany,
and
Dr.
Peter
L.
deFur,
Chairman
of
the
Science
and
Environmental
Health
Network
(
SEHN),
who
agreed
to
provide
their
independent
expert
opinions
to
NRDC
for
this
comment
and
which
NRDC
incorporates
by
reference
into
NRDC's
comments.

Land
application
of
sewage
sludge
has
many
potentially
adverse
human
health
and
environmental
impacts.
Approximately
3.36
million
dry
tons
of
sewage
sludge
is
land
applied
every
year
in
the
United
States.
In
addition
to
human
fecal
matter,
this
materid1
contains
myriad
hazardous
contaminants
from
homes,
businesses,
industries,
and
storm
water
runoff
as
well
as
pathogens.
As
land
application
of
sewage
sludge
has
increased
over
the
past
decade,
so
too
have
reports
of
adverse
health
and
environmental
effects.

Comments
of
Dr.
David
O.
Carpenter
On
February
19,1993,
the
Environmental
Protection
Agency
(
EPA)
published
a
regulation,
40
CFR
Part
503,
that
set
standards
for
contaminants
in
biosolids,
more
commonly
known
as
sewage
sludge.
The
standards
were
based
on
a
risk
assessment
process
and
on
known
contaminants
levels
in
and
current
uses
of
biosolids.
The
risk
assessment
began
in
1982
with
an
Intra­
Agency
Task
Force,
and
was
expanded
to
include
outside
experts
and
contractors.
After
review
by
the
EPA
Science
Advisory
Board,
the
draft
regulation
was
published
in
the
Federal
Register
in
1989.
A
National
Sewage
Sludge
Survey
was
then
conducted
to
analyze
for
contaminants
in
sewage
sludge,
the
results
of
which
were
published
in
the
Federal
Register
in
1990,
and
the
final
regulation
was
published
in
1993.

The
initial
list
of
contaminants
considered
for
regulation
consisted
of
200
pollutants,
where
consideration
was
given
to
human
exposure
and
health
effects,
plant
uptake
and
phytotoxicity,
effects
of
domestic
animals
and
wildlife
and
effects
of
aquatic
organisms,
all
in
relation
to
pollutant
concentration
in
biosolids.
Initial
risk
calculations
were
based
on
the
most
exposed
individuals,
but
after
criticism
that
this
was
too
conservative
an
approach,
they
set
standards
based
on
a
highly
exposed
individual
in
the
final
rule
risk
assessments.
This
was
justified
by
the
statement
that
most
assumptions
were
very
conservative,
and
that
the
most
exposed
individual
probably
did
not
exist.
After
consideration
of
the
200
pollutants,
the
list
was
shortened
to
45.
In
the
final
regulation,
standards
were
set
for
only
ten
contaminants,
all
metals.
These
included
arsenic,
cadmium,
chromium,
copper,
lead,
mercury,
molybdenum,
nickel,
selenium
and
zinc.
Chromium
has
subsequently
been
dropped
from
the
list,
and
at
present
there
are
standards
for
only
nine
metals
plus
requirements
for
pathogen
and
vector
controls
(
EPA,
1995;
Harrison
et
al.,
1999;
National
Academy
of
Sciences,
2002).

It
is
noteworthy
that
in
the
final
rule
no
regulation
of
organic
pollutants
was
included.
This
was
justified
by
the
statement
that
each
organic
pollutant
under
consideration
met
at
least
one
of
the
following
three
criteria
(
EPA,
1995):
USEPA,
2003d
235
1.
The
pollutant
has
been
banned
or
restricted
for
use
in
the
United
States,
or
is
no
longer
manufactured
for
use
in
the
United
States:
2.
The
pollutant
is
not
present
in
biosolids
at
significant
frequencies
of
detection
(
i.
e.,
5%
in
Round
1,
10%
in
Round
2)
based
on
data
gathered
in
the
National
Sewage
Sludge
Survey
in
biosolids;
and
3.
The
limit
for
the
pollutant
identified
in
the
biosolids
risk
assessments
is
not
expected
to
be
exceeded
in
biosolids
that
are
used
or
disposed,
based
on
data
from
the
National
Sewage
Sludge
Survey.

Response
EPA
has
substantially
revised
the
pollutant
selection
process
and
exposure
and
hazard
screening
assessment
as
shown
in
sections
VIII
and
IX
of
today's
FR
notice.

Comments
of
Dr.
Peter
L.
deFur
Introduction
and
Background
EPA
began
the
process
of
identifying
chemicals
in
sewage
sludge
in
1984
when
the
Agency
developed
a
list
of
200
compounds
(
according
to
the
503
Rule;
EPA
1993)
as
a
starting
point
for
regulating
chemicals
and
pathogens
in
sludge.
Subsequently,
EPA
conducted
a
survey
of
chemicals
in
sludge,
analyzing
for
a
list
off
41Icompounds
and
then
sequentially
eliminated
half
the
chemicals
from
that
list.
Chemicals
were
eliminated
on
the
basis
of
presence/
absence,
detection
frequency
(
low),
persistence
(
low)
and
toxicity
or
hazard
(
low).
Through
these
processes
of
elimination,
EPA
eventually
set
regulatory
standards
for
10
chemicals
­
all
metals.
Regulatory
standards
for
two
of
these,
molybdenum
and
chromium,
were
then
challenged
in
court
by
industries
or
industry
associations,
and
EPA
changed
the
regulations
in
response,
withdrawing
the
standards
for
chromium
and
setting
only
a
ceiling
limit
for
molybdenum.

As
agreed
in
consent
decree,
EPA
is
now
completing
another
round
of
standard
setting
for
chemicals
and
pathogens
in
sewage
sludge.
Those
regulations,
which
apply
to
dioxins,
furans,
and
PCBs,
will
be
promulgated
in
Oct.
of
2003.
EPA
is
now
considering
what
additional
chemicals,
should
be
included
in
the
503
rule,
or
what
new
measures
should
be
taken
to
protect
the
environment
and
public
health
from
sewage
sludge
contaminants
(
FR
68
[
68
]
April
9,
2003;
pp
17379­
17395).
The
present
comments
respond
to
the
FR
notice.

Response
EPA
has
substantially
revised
the
pollutant
selection
process
and
exposure
and
hazard
screening
assessment
as
shown
in
sections
VIII
and
IX
of
today's
FR
notice.

Unknown
EPA
Log
#
18:
Anonymous
Comment
Public
Comment
and
Recommendations
To:
USEPA
Subject:
Docket
ID
OW­
2003­
0006
I
would
like
to
say
I
am
in
total
agreement
with
the
submittal
by
the
Sierra
Club
concerning
the
above
mentioned
document.
Additionally,
I
would
submit
that
the
USEPA
has
buried
their
head
in
the
sand
concerning
the
problems
associated
with
sewage
sludge.
OW­
2003­
0006
is
so
pro­
sludge
that
it
lends
no
credence
to
being
anything
of
value.
Stalling,
USEPA,
2003d
236
assigning
research
to
pro­
sludge
scientists,
and
doing
nothing
to
fix
a
worthless
document,
40
CFR
503,
makes
OW­
2003­
0006
just
like
all
other
EPA
OW
attempts
to
stick
sewage
sludge
down
the
rural
population
of
America
to
the
benefit
of
a
few
rich
people.

Response
EPA
is
unable
to
respond
to
general
opinions
that
are
not
backed
up
by
specific
facts.

EPA
Log
#
34:
Anonymous
Comment
Conclusions
and
recommendations
It
is
requested
that
the
EPA
revise
the
response
to
address
each
NRC
recommendation
one
by
one.
The
method
utilized
where
the
EPA
categorized
the
recommendations
has
allowed
to
many
unanswered
recommendations
and
is
unacceptable.
When
answers
are
given
the
EPA
will
need
to
more
specific
and
provide
timelines.
It
is
also
strongly
recommended
that
the
EPA
consider
and
include
a
pre­
application
permitting
program
and
a
volume
based
fee
remittance
program
discussed
herein.

Response
The
Agency
does
not
have
sufficient
resources
to
implement
all
of
the
NRC
recommendations.
With
respect
to
the
commenter's
request
for
EPA
to
be
more
specific,
the
Agency,
in
response
to
public
comments
on
the
draft
April
2003
FR
Notice,
has
in
today's
FR
notice
attempted
in
this
final
response
to
provide
timelines
and
more
details
on
specific
activities
or
research
and
to
better
describe
how
those
activities
address
NRC's
priority
recommendations,
and
areas
the
Agency
believes
will
improve
the
sewage
sludge
program.

Counties
EPA
Log
#
28:
Solano
County
Department
of
Environmental
Management
Comment
On
Behalf
of
the
Solano
County
Department
of
Environmental
Management
we
thank
you
for
the
opportunity
to
comment
on
the
USEPA
response
to
the
National
Academy
of
Sciences
Report
entitled
"
Biosolids
Applied
to
Land:
Advancing
Standards
and
Practices"
(
Docket
#
OW­
2003­
0006).

Solano
County
Department
of
Environmental
Management
(
DEM)
has
been
responsible
for
local
oversight
of
biosolids
land
application
since
1995.
Since
that
time,
Solano
County
DEM,
as
the
local
jurisdiction
regulating
the
biosolids
program,
has
reviewed
and
monitored
the
application
of
Class
B
biosolids
for
compliance
with
the
Federal
Part
503
regulations
on
up
to
approximately
14,000
acres
of
farmland.
Early
this
year,
the
Solano
County
Board
of
Supervisors
held
a
series
of
special
meetings
to
give
experts
an
opportunity
to
present
their
findings
regarding
impacts
of
land
application.
A
list
of
the
speakers
and
the
topic
of
their
presentations
is
provided
in
Attachment
I.
The
outcome
identified
shortcomings
in
the
science
and
application
guidelines
pertaining
to
biosolids,
which
prompted
the
Board
of
Supervisors
to
adopt
more
stringent
local
regulations
governing
the
land
applications
of
biosolids
in
Solano
County
(
a
copy
of
the
code
is
provided
in
Attachment
II).
New
amendments
to
the
local
code
included
the
authorization
to
establish
a
fee
to
fund
research
pertinent
to
the
land
application
of
biosolids
in
Solano
County
in
order
to
assist
in
USEPA,
2003d
237
collection
of
information
about
the
safety
or
potential
health
impacts
of
the
practice.
To
assist
in
identifying
research
priorities,
Solano
County
has
sought
out
stakeholders
to
be
part
of
a
temporary
scientific
research
advisory
committee.
Stakeholders
on
this
committee
represent
biosolids
generators,
applicators,
concerned
citizens,
local
government
officials,
farmers,
governmental
agencies,
and
environmental
groups.

Among
the
necessary
research
topics
identified
by
this
committee
are:
1.
Pathogen
re­
growth
and
desiccation
(
mortality)
within
land
applied
biosolids.
2.
Research
on
constituents
within
biosolids,
including
regulated
and
non­
regulated
chemicals
(
organic
and
inorganic),
emerging
chemical
concerns
(
pharmaceuticals,
endocrine
disrupters),
and
pathogens
and
their
mortality
or
residuals
in
the
environment
when
land
applied.
3.
Formalized
tracking
of
possible
incidents
of
health
complaints
for
people
and
animals
where
exposure
to
biosolids
is
suspected.
3a.
Local
reporting
and
rapid
epidemiological
response
methodology
to
investigate
reported
health
impacts.
3b.
Outreach
and
education
to
health
care
providers
on
recognizing,
evaluating,
and
testing
of
health
symptoms
and
biosolids
land
application
practices,
and
on
reporting
health
incidents.
3c.
Epidemiological
studies,
including
blood
work
and
baselines.
3d.
Link
between
land
spreading
of
biosolids
and
increase
in
incidents
of
asthma.
4.
Field
verification
of
leaching
of
metals,
insecticides,
pathogens,
pharmaceuticals
and
endocrine
disrupters
from
biosolids
into
soils,
surface
water,
and
ground
water
on
as
well
as
off
sites
where
land
applications
of
biosolids
occurs.
5.
tissue
and/
or
reproductive
studies
on
animals
grazing
in
biosolids
applied
fields,
or
eating
feed
from
biosolids
fields.
6.
Adequacy
of
prescribed
management
processes,
including
both
treatment
process
and
land
application
practices.
7.
Agronomic
effects
and
rates
(
PKN)
comparison
between
biosolids
and
other
fertilizers
or
soil
amendments.
8.
Aerosol
transmission
of
pathogens,
odorants,
toxic
compounds,
and
particulates
associated
with
current
land
spreading
practices
of
biosolids.
9.
Effects
to
public
health,
wildlife,
and
the
environment,
including
regional
watershed
analysis
for
on
and
off
site
effects
to
water
quality
(
surface
water
and
groundwater)
resulting
from
run
off
or
percolation
of
constituents
in
biosolids
and
potential
for
biological
accumulation
in
livestock,
plants
and
wildlife.
9a.
Measurement
of
contaminant
accumulation
over
time
in
soil
and
water
at
a
site
resulting
from
land
spreading
of
biosolids.
9b.
Monitor
effects
of
runoff
resulting
from
irrigation
and
rainfall
from
fields
applied
with
Biosolids.
10.
Vector
attraction
reduction
studies.

Response
The
Agency
appreciates
the
commenter
bringing
to
our
attention
research
priorities
developed
by
the
Solano
County
Department
of
Environmental
Management.
Projects
1­
14
in
Section
VII
of
today's
final
action
plan
captures
much
of
the
items
in
the
above
list.
As
the
USEPA,
2003d
238
commenter
will
appreciate,
the
Agency
does
not
have
sufficient
resources
to
address
all
of
these
research
items.

States
EPA
Log
#
53:
Michigan
Department
of
Environmental
Quality
Comment
I
wish
to
acknowledge
the
both
the
comments
submitted
by
the
Wisconsin
Department
of
Natural
Resources
in
their
capacity
as
spokes­
agency
for
state
biosolids
programs
in
general
and
the
comments
submitted
individually
by
the
Wisconsin
DNR.
I
agree
with
both
sets
of
comments
submitted
by
Wisconsin
DNR.

Response
No
response
needed.

Municipalities
EPA
Log
#
55:
City
of
Rio
Vista,
California
Comment
I
am
the
mayor
of
a
small
town
in
Northern
California.
Local
residents
began
calling
our
city
hall
in
August
2001
with
complaints
about
terrible
odors,
problems
with
breathing,
headaches
and
an
infestation
of
flies.
Some
thought
there
had
been
an
upwind
chemical
release
or
an
upset
at
our
sewer
plant.
Within
a
week
or
so,
the
source
of
the
complaints
was
identified
as
biosolids
that
were
being
land­
applied
on
nearby
grazing
land.

Since
that
time,
our
City
Council
has
been
involved
in
learning
about
the
regulatory
scheme
that
sanctions
land
disposal
of
treated
sewer
sludge
waste.
We
have
reviewed
the
National
Research
Council
report
and
participated
in
many
meetings
where
scientists
made
extensive
presentations
to
the
Solano
County
Board
of
Supervisors.
We
have
become
educated
about
the
current
national
debate
over
biosolids
because
our
residents
are
extremely
concerned
about
land
application
'
s
possible
impacts
on
their
health,
our
environment
and
our
sole
water
source,
our
groundwater
supply.

We
have
been
so
concerned
that
after
reviewing
the
NRC
Report
and
listening
to
in­
depth
scientific
presentations
on
all
sides
of
the
issue,
we
asked
our
county
supervisors
to
suspend
land
application
in
our
county.
We
have
concluded
that
until
additional
scientific
research
answers
the
many
unanswered
questions
about
the
safety
of
this
widespread
practice,
we
will
not
be
able
to
give
assurances
to
our
residents
that
land
application
is
not
to
be
a
threat
to
them
and
their
families.
With
great
anticipation,
therefore,
we
awaited
the
publication
of
EPA
'
s
response
to
the
NRC
Report,
hoping
to
find
a
plan
to
provide
answers
to
our
questions.

However,
after
reviewing
EPA
'
s
so­
called
"
Action
Plan
"
it
is
with
great
disappointment
that
we
conclude
that
the
plan
as
proposed
will
not
adequately
address
our
continuing
local
concerns.
USEPA,
2003d
239
Putting
aside
the
Action
Plan
and
its
deficiencies,
the
City
of
Rio
Vista
and
its
residents
want
to
know
the
following:

°
the
short
and
long­
term
health
effects
of
ongoing
exposure
to
airborne
contaminants
from
biosolids
on
all
our
people,
including
our
elderly,
children
and
immune­
compromised.
(
We
live
downwind
of
thousands
of
acres
where
land
application
occurs
and
experience
extremely
high
winds
throughout
the
April
 
October
spreading
season..)

°
what
is
in
each
load
of
sludge
that
is
land­
applied
near
us
(
EPA
continues
to
rely
on
performance­
based
assumptions
and
rejects
NRC
'
s
call
for
field
verification
of
the
reliability
of
the
treatment
process.)

°
the
rules
under
which
sludge
is
land­
applied
are
adequate
to
protect
us
and
are
being
enforced
by
regulators.(
The
NRC
report
discloses
how
few
staff
are
dedicated
to
the
regulatory
program
at
all
levels
of
government,
including
the
EPA.)

°
there
is
an
regulatory
agency
that
will
respond
to
incidents
promptly
and
reliably
address
our
legitimate
concerns
when
we
experience
health
symptoms
or
suspect
a
violation
of
the
land­
application
rules.
(
Today
most
sludge­
impacted
people
have
no
one
to
report
their
concerns
to.)

Finally,
as
we
review
the
history
of
the
federal
regulation
of
biosolids,
several
themes
emerge.
The
first
is
expediency.
Land
application
was
allowed
and
encouraged
primarily
because
of
society
'
s
need
to
find
a
way
to
dispose
of
treated
sewage
sludge.
After­
the­
fact
attempts
to
shore
up
that
policy
decision
with
research
have
never
caught
up
with
the
failure
to
lay
an
adequately
supported
foundation
for
the
practice,
particularly
in
the
area
of
public
health.

EPA
has
the
opportunity
to
change
direction
and
write
a
new
chapter
in
its
history
with
this
Action
Plan.
It
would
be
well
to
do
so
because,
at
least
in
California,
it
is
no
longer
expedient
to
continue
business
as
usual.
The
general
public
is
becoming
too
concerned
and
a
biosolids
disposal
crisis
is
in
the
making.
Local
governments
are
banning
land
application
over
their
residents
concerns
about
biosolids.
As
a
practical
matter,
the
grassroots
may
decide
this
debate
through
demanding
that
their
local
representatives
address
the
issue,
if
the
federal
government
will
not.

Response
EPA
thanks
the
commenter
for
bringing
attention
to
these
information
needs
and
believes
that
the
final
action
plan
described
in
today's
Federal
Register
Notice
(
in
particular
Projects
No.
2
,
4,
6,
7,
and
14
in
Section
VII)
will
generate
much
of
the
information
requested
by
the
commenter.