Document ID: EPA-HQ-OW-2003-0006-0016
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-04-02T05:00Z

USEPA
2002a
1
Compilation
of
National
Research
Council
(
NRC)
Recommendations
on
Biosolids
NRC
Recommendation
(
OA=
overarching,,
OACS=
overarching
chemical
standards,
OACP=
overarching
chemical/
pathogen
standards,
OAPS=
overarching
pathogen
standards,
OAHE=
overarching
health
effects,
OACP=
overarching
chem,
ical/
pathogen
,
CH#­#=
chapter#­

recommendation
#)
Category
Survey
OA­
2.
Conduct
a
new
national
survey
of
chemicals
and
pathogens
in
sewage
sludge.
The
committee
endorses
the
recommendation
of
a
previous
NRC
committee
that
a
new
national
survey
of
chemicals
be
performed.
The
committee
further
recommends
a
survey
of
pathogen
occurrence
in
raw
and
treated
sewage
sludges.
The
survey
should
include
a
careful
examination
of
management
practices
to
ensure
that
risk­
assessment
principles
are
effectively
translated
into
practice.
Data
from
the
survey
should
be
used
to
provide
feedback
for
continuous
improvement
in
the
science
and
technology
of
biosolids
applied
to
land.
Survey
Risk
Assessment
OAPS­
1.
EPA
should
conduct
a
national
survey
of
pathogen
occurrence
in
raw
and
treated
sewage
sludges.
Important
elements
in
conducting
the
survey
include
use
of
consistent
sampling
methods,
analysis
of
a
broad
spectrum
of
pathogens
that
could
be
present
in
sewage
sludge,
and
use
of
the
best
available
(
preferably
validated)
pathogen
measurement
techniques.
Survey
OACS­
2.
As
recommended
by
an
earlier
NRC
committee,
a
new
national
survey
of
chemicals
in
biosolids
should
be
conducted.
EPA
should
review
available
databases
from
state
programs
in
designing
a
new
survey.
Other
elements
that
should
be
included
in
the
survey
are
an
evaluation
of
the
adequacy
of
detection
methods
and
limits
to
support
risk
assessment;
consideration
of
chemical
categories,
such
as
odorants
and
pharmaceuticals,
that
were
not
previously
evaluated;
and
assessment
of
the
presence
of
multiple
species
of
certain
metals,
such
as
mercury
and
arsenic,
that
have
different
toxicity
end
points.
Data
from
this
survey
should
be
used
to
identify
any
additional
chemicals
for
potential
regulation.
Survey
Risk
Assessment
CH5­
3.
The
committee
endorses
the
recommendation
of
the
previous
NRC
committee
(
NRC
1996)
that
a
new
national
survey
of
chemicals
in
biosolids
be
conducted.
It
recognizes
that
more
recent
survey
data
are
available
through
many
state
programs
and
recommends
that
EPA
consider
those
databases
in
the
course
of
designing
a
new
national
survey.
Other
elements
that
should
be
included
in
a
new
survey
are
the
following:
evaluation
of
the
adequacy
of
analytical
methods
and
detection
limits
to
support
risk
assessment;
consideration
of
categories
of
chemicals
of
current
concern
that
were
not
previously
evaluated
(
e.
g.,
odorants,
surfactants,
and
pharmaceuticals);
and
assessment
of
the
possible
presence
of
multiple
species
of
mercury,
arsenic,
and
other
metals
that
have
different
toxic
end
points.
Survey
Risk
Assessment
CH5­
8.
In
addition
to
the
recommendations
above
for
a
new
biosolids
survey
and
chemical
selection
process,
it
is
recommended
that
a
research
program
be
developed
for
pharmaceuticals
and
other
chemicals
likely
to
be
present
in
biosolids
that
are
not
currently
included
in
routine
monitoring
programs.
This
included
chemicals
eliminated
from
Round
1
and
Round
2
evaluations
because
of
data
gaps.
The
research
program
should
have
the
goal
of
identifying
additional
chemicals
that
should
be
included
in
routine
biosolids
surveys,
and
in
future
risk
assessments.
For
odorants,
research
is
needed
to
identify
the
odorants
present
in
various
kinds
of
biosolids.
For
odorants
commonly
present
in
biosolids,
EPA
should
move
more
aggressively
to
develop
acute
toxicity
values
for
use
in
assessing
the
risks
posed
by
these
chemicals
and
should
support
research
on
the
interaction
between
these
chemicals
and
pathogens
in
causing
human
disease.
Survey
Exposure
Risk
Assessment
USEPA
2002a
2
CH6­
1.
EPA
should
conduct
a
national
survey
of
pathogen
occurrence
in
raw
and
treated
sewage
sludges.
Important
elements
in
conducting
the
survey
include
use
of
consistent
sampling
methods,
analysis
of
a
broad
spectrum
of
pathogens
that
could
be
in
sewage
sludge,
and
use
of
the
best
available
(
preferably
validated)
pathogen
measurement
techniques.
Survey
Exposure
OACS­
3.
Aggregate
exposure
assessments
should
be
performed.
A
conceptual
site
model
should
be
used
to
identify
major
and
minor
exposure
pathways
for
various
application
scenarios.
Special
consideration
should
be
given
to
identifying
the
application
practices
and
environmental
conditions
that
are
likely
to
result
in
the
greatest
human
exposure.
Risks
from
long­
term
low­
level
exposures,
as
well
as
short­
term
episodic
exposures,
such
as
those
that
can
occur
with
volatile
chemicals
should
be
evaluated.
Exposure
OACS­
4.
An
RME
individual,
rather
than
an
HEI,
should
be
evaluated
for
each
exposure
pathway.
Use
of
the
RME
is
a
more
informed
and
reasonable
estimate
of
exposure
than
the
HEI
because
it
reduces
reliance
on
the
subjective
application
of
default
assumptions
and
reflects
improved
methods
of
characterizing
population
exposure.
When
the
RME
individual
is
likely
to
be
exposed
by
more
than
one
pathway,
exposures
should
be
added
across
pathways.
Exposure
OACS­
5.
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.
Exposure
CH3­
2.
Biosolids
exposure­
assessment
studies.
Such
studies
should
characterize
the
exposures
of
workers,
such
as
biosolids
appliers
and
farmers,
and
the
general
public
who
come
into
contact
with
constituents
of
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.
A
possible
exposureassessment
study
would
be
to
measure
endotoxin
exposure
of
workers
at
biosolids
production
and
application
sites
and
of
communities
nearby.
Exposure
Human
Health
Studies
CH5­
5.
A
new
risk
assessment
should
include
separate
exposure
scenarios
that
represent
substantial
differences
in
exposure
potential
(
e.
g.,
land
reclamation
and
forestry
applications).
For
each
scenario,
a
conceptual
site
model
approach
should
be
used
to
identify
major
and
minor
exposure
pathways
and
routes
of
exposure.
Risks
from
short­
term
episodic
exposures
should
also
be
evaluated
for
volatile
chemicals,
such
as
odorants.
Exposure
CH5­
6.
A
comparable
reasonable
maximum
exposure
(
RME)
should
be
evaluated
for
each
exposure
pathway
in
each
exposure
scenario,
and
where
the
same
receptor
is
likely
to
be
exposed
to
more
than
one
pathway,
exposures
should
be
added
across
pathways.
Such
considerations
are
applicable
for
both
deterministic
and
probabilistic
exposure
assessment
approaches.
Multiple
highly
conservative
assumptions
should
be
avoided;
however,
care
should
be
taken
to
ensure
that
the
risks
are
assessed
for
the
high­
end
population
and
that
the
most
sensitive
conditions
for
biosolids
application
are
considered.
For
example,
for
the
groundwater
infiltration
pathway,
if
biosolids
application
is
likely
to
occur
in
areas
of
sandy
soil
or
karst
topography
with
shallow
groundwater,
those
conditions
should
be
used
in
the
risk
assessment.
Exposure
CH5­
7.
The
most
recent
EPA
reviews
and
new
studies
reported
in
the
literature
should
be
used
to
identify
updated
assumptions
for
exposure
parameters
for
use
in
risk
assessment.
Updated
fate
and
transport
models
should
be
used
to
estimate
exposure
point
concentrations.
For
each
exposure
pathway,
fate
and
transport
models
and
exposure
parameter
assumptions
should
be
selected
so
that
pathway
exposures
reflect
the
RME.
Exposure
Risk
Assessment
USEPA
2002a
3
CH6­
5.
As
recommended
in
Chapter
5
for
chemicals,
EPA
should
develop
a
conceptual
site
model
to
identify
the
major
and
minor
exposure
pathways
(
including
secondary
transmission)
by
which
humans
might
come
into
contact
with
pathogens
in
biosolids.
Exposure
CH7­
2.
Research
should
be
conducted
to
synthesize
existing
information
on
potential
interaction
of
chemicals
and
pathogens
that
might
be
associated
with
biosolids
exposures
and
lead
to
an
increased
susceptibility
to
infection,
particularly
by
inhalation.
Exposure
Risk
Assessment
Risk
Assessment
OA­
1.
Use
improved
risk­
assessment
methods
to
better
establish
standards
for
chemicals
and
pathogens.
Risk­
assessment
methods
for
chemicals
and
pathogens
have
advanced
over
the
past
decade
to
the
extent
that
(
1)
new
risk
assessments
should
be
conducted
to
update
the
scientific
basis
of
the
chemical
limits,
and
(
2)
risk
assessments
should
be
used
to
supplement
technological
approaches
to
establishing
regulatory
criteria
for
pathogens
in
biosolids.
Risk
Assessment
OACS­
1.
Using
current
risk­
assessment
practices,
EPA
should
reassess
the
standards
for
the
regulated
chemicals
and
conduct
another
chemical
selection
process
to
determine
whether
additional
chemicals
should
be
considered
for
regulation.
On
the
basis
of
the
revised
risk
assessments
and
chemical
selection,
EPA
can
determine
whether
the
standards
or
risk­
management
process
should
be
revised
and
whether
additional
chemicals
should
be
regulated.
Because
the
landapplication
standards
are
to
be
relevant
nationally,
it
is
important
that
the
revised
risk
assessments
reflect
regional
variations
in
climate,
hydrology,
and
biosolids
use
and
characteristics,
and
that
standards
are
protective
of
populations
reflecting
reasonable
estimates
of
maximum
exposure.
The
chemical
standards
should
be
reevaluated
and
updated
periodically
to
ensure
that
they
are
supported
by
the
best
available
scientific
data
and
methods.
B,
C
Risk
Assessment
OAPS­
2.
QMRAs
should
be
developed
and
used
to
establish
regulatory
criteria
(
treatment
requirements,
use
restrictions,
and
monitoring)
for
pathogens
in
biosolids.
For
example,
EPA
could
stipulate
an
acceptable
risk
level
for
a
particular
pathogen.
QMRA
could
then
be
used
to
estimate
the
concentration
of
that
pathogen
in
biosolids
either
at
the
point
of
application
(
where
there
is
immediate
potential
for
exposure)
or
following
any
required
holding
period.
EPA
could
then
determine
experimentally
based
relationships
between
the
maximum
acceptable
pathogen
concentration
and
the
process
conditions
(
e.
g.,
time,
temperature,
pH,
chemical
doses,
and
holding
times)
and/
or
the
pathogen
indicator
concentrations
(
either
density
or
reduction
through
treatment).
On
the
basis
of
those
relationships,
regulatory
criteria
and
monitoring
for
land
application
can
be
updated
or
developed
to
ensure
consistent
attainment
of
target
pathogen
concentrations.
To
conduct
QMRAs,
a
conceptual
site
model
should
be
used
to
identify
all
potential
routes
of
exposure;
additional
input
data
(
e.
g.,
dose­
response
and
pathogen­
survival
data)
should
be
collected;
and
consideration
should
be
given
to
potential
secondary
transmission
of
infectious
disease.
QMRAs
also
can
be
used
to
analyze
sensitivity
and
to
ascertain
what
critical
information
is
needed
to
reduce
uncertainty
about
the
risks
from
exposure
to
pathogens
in
biosolids.
The
pathogen
standards
should
be
reevaluated
and
updated
periodically
to
ensure
that
they
are
supported
by
the
best
available
scientific
data
and
methods
and
to
ensure
that
anecdotal
information
is
not
being
used
for
the
predication
of
past,
current,
or
future
regulations.
Risk
Assessment
Pathogens
Regulatory
Activities
OACS­
6.
Representatives
of
stakeholders
should
be
included
in
the
risk­
assessment
process
to
help
identify
exposure
pathways,
local
conditions
that
could
influence
exposure,
and
possible
adverse
health
outcomes.
Risk
Assessment
Exposure
USEPA
2002a
4
CH4­
1.
Because
of
the
significant
changes
in
risk­
assessment
methods
and
policies
over
the
last
decade,
EPA
should
revise
and
update
the
Part
503
rule
risk
assessments.
Important
developments
include
recognition
of
the
need
to
include
stakeholders
throughout
the
risk­
assessment
process,
improvements
in
measuring
and
predicting
adverse
health
effects,
advances
in
measuring
and
predicting
exposure,
explicit
treatment
of
uncertainty
and
variability,
and
improvements
in
describing
and
communicating
risk.
EPA
should
consider
how
the
updated
risk
assessments
would
change
the
risk­
management
process.
A
similar
approach
can
be
taken
with
the
issue
of
biological
agent
risks.
Risk
Assessment
CH4­
4.
Because
there
are
no
guidelines
to
ensure
that
conditions
assumed
in
the
risk
assessment
actually
transpire,
the
committee
recommends
that
the
Part
503
rule
provide
guidance
for
periodic
reassessments
that
will
be
used
to
ensure
that
the
demographic
and
operational
conditions
of
biosolids
land
application
are
consistent
with
the
assumptions
of
the
applicable
risk
assessment.
Risk
Assessment
Regulatory
Activities
CH5­
1.
A
revised
multipathway
risk
assessment
should
be
performed
for
the
currently
regulated
pollutants,
with
particular
attention
paid
to
arsenic
and
to
indirect
exposure
pathways
for
cadmium
and
mercury.
Additionally,
new
survey
data
should
be
used
to
identify
any
additional
inorganic
or
organic
pollutants
that
might
need
to
be
included
in
a
risk
assessment.
Risk
Assessment
CH5­
2.
Risk­
based
standards
for
land
application
of
biosolids
should
be
reevaluated
on
a
regular
basis
to
take
into
account
new
information
regarding
the
identity
and
properties
of
chemicals
present
in
these
mixtures
and
current
approaches
to
evaluating
the
risks
of
exposure
to
such
mixtures.
Stakeholders
should
be
included
in
the
process,
particularly
in
the
development
of
the
exposure
assessments.
Risk
Assessment
Exposure
CH5­
4.
Selected
persistent,
bioaccumulative,
and
highly
toxic
chemicals
should
be
retained
in
the
risk
assessment
even
if
they
are
detected
relatively
infrequently
or
if
some
chemical­
specific
fate
and
transport
parameters
are
missing.
An
uncertainty
assessment
should
be
performed
to
evaluate
the
significance
of
eliminating
chemicals
from
the
risk
assessment
because
of
lack
of
toxicity
data
or
other
parameters.
Risk
Assessment
CH6­
7.
QMRAs
should
be
developed
and
used
to
establish
(
or
validate)
regulatory
criteria
(
treatment
processes,
use
restrictions,
and
monitoring)
for
pathogens
in
biosolids.
They
can
also
be
used
for
sensitivity
analyses
and
identifying
critical
information
that
is
needed
to
reduce
uncertainty
about
the
risks
from
pathogens
in
biosolids.
To
conduct
these
risk
assessments,
consideration
must
be
given
to
assessing
risks
from
all
potential
routes
of
exposure
(
e.
g.,
bioaerosols,
groundwater),
dose­
response
relationships,
pathogen
survival,
and
secondary
transmission
of
disease.
In
some
cases,
research
will
be
needed
to
fill
gaps
in
knowledge
of
those
inputs.
As
additional
information
is
gathered
on
exposure,
dose­
response
relationship,
and
pathogen
survival,
the
risk
assessments
should
be
reviewed
and
updated
as
necessary.
Risk
Assessment
Survey
Pathogens
Regulatory
Activities
CH7­
3.
As
outlined
in
Chapters
5
and
6,
future
risk
assessments
of
biosolids
components
should
be
conducted
using
the
most
current
methods
and
data.
For
pathogens,
it
is
important
that
risk
assessments
include
an
evaluation
of
the
potential
for
secondary
transmission
of
disease.
Representatives
from
all
stakeholders
should
be
included
in
future
risk
assessments.
Stakeholders
can
provide
information
and
insights
into
the
use
of
biosolids
in
practice
and
the
potential
health
problems,
which
are
particularly
important
in
the
development
of
exposure
assessment.
Involving
stakeholders
throughout
the
risk­
assessment
process
provides
opportunities
to
bridge
gaps
in
understanding,
language,
values,
and
perspectives.
Risk
Assessment
Pathogens
Methods
Development
OAPS­
3.
EPA
should
foster
development
of
standardized
methods
for
measuring
pathogens
in
biosolids
and
bioaerosols.
Methods
Development
USEPA
2002a
5
OAPS­
4.
EPA
should
promote
research
that
uses
improved
pathogen
detection
technology
to
better
establish
the
reliability
of
its
prescribed
pathogen
treatment
processes
and
biosolids­
use
controls
to
achieve
and
maintain
minimal
exposure
over
time.
In
setting
pathogen
treatment
requirements,
it
might
be
useful
to
establish
metrics
for
typical
(
mean)
treatment
performance
and
concentrations
not
to
be
exceeded.
Methods
Development
CH4­
2.
Many
of
the
measures
of
risk
used
in
developing
the
Part
503
rule
guidelines
cannot
be
monitored.
Because
of
that
inability
to
monitor,
the
committee
acknowledges
that
EPA
must
perform
theoretical
risk
assessments.
Nevertheless,
there
is
a
continuing
need
to
provide
some
measures
of
performance
that
can
be
monitored
(
e.
g.,
concentrations
of
selected
chemicals
in
exposure
media,
such
as
indoor
air,
house
dust,
or
tap
water
of
residences
near
land­
application
sites;
and
exposure
biomarkers
in
the
blood
or
urine
of
nearby
residents).
Recent
improvements
in
health
surveillance
and
exposure
monitoring
provide
new
opportunities
for
EPA
to
develop
more
explicit
and
measurable
metrics
of
performance
for
biosolids
land­
application
practices.
Methods
Development
Survey
CH6­
6.
EPA
should
foster
development
of
standardized
methods
for
measurement
of
pathogens
in
biosolids
and
bioaerosols.
EPA
should
include
round­
robin
laboratory
testing
to
establish
method
accuracies
and
precisions
at
the
various
pathogen
concentrations
expected
in
raw
sewage
sludge
and
partially
and
fully
treated
biosolids.
These
new
detection
methods
should
be
used
to
verify
that
EPA's
prescribed
pathogen
reduction
techniques
are
reliable
in
achieving
their
intended
goals.
Mechanisms
should
be
developed
for
incorporating
new
methodologies
into
the
verification
process
as
they
become
available.
Methods
Development
Pathogens
OAPS­
5.
Research
should
be
conducted
to
assess
whether
other
indicator
organisms,
such
as
Clostridium
perfringens,
could
be
used
in
regulation
of
biosolids.
Such
indicators,
along
with
traditional
indicators
and
operational
parameters,
may
be
suitable
for
monitoring
day­
to­
day
regulatory
compliance.
Pathogens
CH2­
5.
The
PEC
should
be
funded,
supported,
and
officially
sanctioned
as
an
integral
part
of
the
federal
biosolids
program.
The
following
are
important
in
supporting
the
PEC:
°
The
PEC
members
should
have
a
formal
portion
of
their
time
allocated
to
PEC
responsibilities.
°
Travel
funds
should
be
put
at
the
disposal
of
the
PEC
to
enable
meeting
attendance
and
visits
to
selected
sites
of
petitioners.
°
There
is
a
perception
on
the
part
of
PEC
members
that
EPA's
Cincinnati
laboratories
do
not
include
biosolids
as
a
formal
part
of
their
mission
statement.
This
needs
to
be
clarified
and
rectified.
°
A
formal
procedure
for
designation
of
backup
members
should
be
devised.
Pathogens
Biosolids
Management
CH2­
8.
Provisions
for
allowing
distribution
Class
A
biosolids
in
bags
or
other
containers
(
weighing
less
than
1
metric
ton)
should
not
be
allowed
when
they
do
not
meet
pollutant
concentration
limits
(
i.
e.,
all
biosolids
sold
or
given
away
should
be
EQ).
Pathogens
Regulatory
Activities
CH2­
10.
EPA
should
conduct
national
field
and
laboratory
surveys
to
verify
that
Class
A
and
Class
B
treatment
processes
perform
as
assumed
by
their
engineering
and
design
principles.
Determinations
should
be
made
of
pathogen
density
and
elimination
across
the
various
accepted
treatment
processes
and
in
the
biosolids
or
environmental
media
over
time.
Pathogens
Survey
CH2­
13.
EPA
should
support
development,
standardization,
and
validation
of
detection
and
quantification
methods
for
pathogens
and
indicator
organisms
regulated
under
the
Part
503
rule.
The
sufficiency
of
these
methods
and
their
results
should
be
considered
in
conducting
and
interpreting
future
risk
assessments
and
used
to
develop
applicable
risk­
management
technologies.
Pathogens
Methods
Development
USEPA
2002a
6
CH2­
15.
Research
is
needed
on
the
following
topics:
°
Pathogen
survival
in
processing
or
emissions
during
the
treatment
process.
°
Vectors
carrying
pathogens
and
toxins.
°
Bioaerosols
and
other
chemical
aerosols.
°
Test­
method
development
and
validation
for
various
organisms
in
sewage
sludge
and
biosolids.
°
Field
verification
of
efficacy
of
Class
A
and
Class
B
treatment
processes
(
including
data
to
directly
relate
process
controls
to
initial
and
final
pathogen
and
indicator
densities).
°
Development
of
indicator
pathogens
for
assessment
of
impact
and
attenuation
in
field
situations.
Pathogens
Survey
Risk
Assessment
CH6­
2.
Additional
indicator
organisms,
such
as
Clostridium
perfringens,
should
be
considered
for
potential
use
in
regulation
of
land­
applied
biosolids.
Such
indicators
and
other
operational
parameters
(
e.
g.,
time,
temperature,
pH,
and
chemical
dose)
may
be
suitable
for
assessing
day­
today
compliance
with
the
regulations.
Pathogens
CH6­
3.
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.
Pathogens
CH6­
4.
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.
Pathogens
Human
Health
Studies
Human
Health
Studies
OAHE­
1.
Although
routine
human
health
surveillance
of
all
populations
exposed
to
biosolids
is
impractical,
the
committee
recommends
that
EPA
promote
and
support
response
investigations,
targeted
exposure
surveillance
studies,
and
a
few
well­
designed
epidemiological
investigations
of
exposed
populations.
This
recommendation
is
intended
to
provide
a
means
of
documenting
whether
health
effects
exist
that
can
be
linked
to
biosolids
exposure.
The
committee
recommends
the
following
types
of
studies:

Studies
in
response
to
unusual
exposures
and
unusual
occurrences
of
disease.
Occasionally,
the
occurrence
of
unusual
events
can
provide
information
on
the
agents
of
disease.
For
example,
an
outbreak
or
a
symptom
of
disease
might
occur
following
a
known
exposure
or
an
unusual
exposure
scenario.
In
both
instances,
exposure
and
health
outcomes
should
be
determined.

Preplanned
exposure­
assessment
studies.
Such
studies
should
characterize
the
exposures
of
workers,
such
as
biosolids
appliers
and
farmers,
and
the
general
public
who
come
into
contact
with
constituents
of
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.
A
possible
exposureassessment
study
would
be
to
measure
endotoxin
exposure
of
workers
at
biosolids
production
and
application
sites
and
of
communities
nearby.

Complete
epidemiological
studies
of
biosolids
use.
These
studies
should
be
conducted
to
provide
evidence
of
a
causal
association,
or
a
lack
thereof,
between
biosolids
exposure
and
adverse
human
health
effects.
They
should
include
an
assessment
of
the
occurrence
of
disease
and
an
assessment
or
measurement
of
potential
exposures.
An
example
of
a
longitudinal
epidemiological
study
would
be
Human
Health
Studies
Exposure
USEPA
2002a
7
an
evaluation
of
health
effects
in
a
cohort
of
biosolids
appliers
These
workers
should
be
characterized
by
duration
and
level
of
exposure,
and
given
appropriate
follow­
up.
Because
complete
epidemiological
studies
are
expensive
and
require
extensive
data
analysis,
priority
should
be
given
to
studies
that
can
address
serious
or
widespread
problems
and
help
reduce
uncertainty.

CH3­
1.
Studies
in
response
to
unusual
exposure
and
unusual
occurrence
of
disease.
On
occasion,
unplanned
events
occur
that
can
provide
information
on
the
agents
of
disease.
An
example
might
be
an
outbreak
or
a
symptom
of
disease
following
a
known
exposure
or
an
unusual
exposure
scenario.
In
both
instances,
exposure
and
health
outcomes
should
be
determined.
Human
Health
Studies
CH3­
3.
Complete
epidemiological
studies
of
routine
biosolids
use.
These
studies
should
be
conducted
to
provide
evidence
of
a
causal
association,
or
a
lack
thereof,
between
biosolids
exposure
and
adverse
human
health
effects.
They
should
include
an
assessment
of
the
occurrence
of
disease
and
an
assessment
or
measurement
of
potential
exposures.
An
example
of
a
longitudinal
epidemiological
study
would
be
an
evaluation
of
health
effects
in
a
cohort
of
biosolids
appliers;
these
workers
should
be
characterized
by
duration
and
level
of
exposure,
with
appropriate
followup
Human
Health
Studies
Regulatory
Activities
CH2­
6.
Studies
should
be
conducted
to
determine
whether
the
management
practices
specified
in
the
Part
503
rule
(
e.
g.,
10­
meter
setback
from
waters)
achieve
their
intended
effect.
Regulatory
Activities
CH2­
7.
Additional
risk­
management
practices
should
be
considered
in
future
revisions
to
the
Part
503
rule,
including
setbacks
from
residences
or
businesses,
setbacks
from
private
and
public­
water
supply
wells,
slope
restrictions,
soil
permeability
and
depth
to
groundwater
or
bedrock,
and
reexamination
of
whether
a
greater
setback
distance
to
surface
water
is
warranted.
Regulatory
Activities
CH2­
9.
Exemptions
from
nutrient
management
and
site
restrictions
for
land
application
of
bulk
EQ
biosolids
should
be
eliminated.
Regulatory
Activities
CH2­
11.
Standard
treatment
design
criteria
should
be
adopted
nationally
to
ensure
compliance
with
existing
biosolids
regulations.
Regulatory
Activities
CH2­
12.
Stabilization
controls
need
to
be
further
refined
and
directly
correlated
to
metabolic
techniques
(
e.
g.,
SOUR
test,
carbon
dioxide
metabolic
release,
methane
metabolic
release).
Regulatory
Activities
Pathogens
CH2­
14.
As
part
of
the
process
of
revising
the
Part
503
rule,
EPA
should
review
biosolids
protocols
used
by
other
nations.
This
could
provide
valuable
new
perspectives
and
insights
into
the
scientific,
technical,
and
societal
bases
for
the
development
and
implementation
of
biosolids
regulations.
Regulatory
Activities
Biosolids
Management
OA­
3.
Establish
a
framework
for
an
approach
to
implement
human
health
investigations.
A
procedural
framework
should
be
established
to
implement
human
health
investigations,
including
short­
term
investigations
of
unusual
episodes
of
release,
exposure,
or
disease
and
large­
scale
preplanned
studies
of
exposures
and
their
association,
if
any,
with
disease.
The
framework
should
have
mechanisms
to
document
state­
of­
the­
art
successes,
both
technological
and
administrative,
in
preventing
or
remediating
exposure
to
pathogens
and
toxicants
and
their
adverse
health
outcomes.
Further,
the
framework
should
include
a
means
for
tracking
allegations
and
sentinel
events
(
compliance,
management,
or
health
based),
investigations,
and
conclusions.
Such
tracking
should
be
systematic
and
developed
in
cooperation
with
states.
Biosolids
Management
USEPA
2002a
8
OA­
4.
Increase
the
resources
devoted
to
EPA's
biosolids
program.
To
remedy
the
deficiencies
and
to
implement
the
recommendations
described
in
this
report,
more
funding
and
staff
resources
are
needed
for
EPA's
biosolids
program.
EPA
should
support
and
facilitate
greater
delegation
of
authority
to
states
to
administer
the
federal
biosolids
regulation.
Resources
are
also
needed
for
conducting
needed
research
and
to
revise
the
regulation
as
appropriate
and
in
a
timely
fashion.
Biosolids
Management
Regulatory
Activities
OACP­
1.
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
committee
recommends
that
Figure
S­
1
be
used
by
EPA
as
a
framework
for
establishing
such
a
program.
The
central
part
of
the
figure
presents
the
general
process
by
which
biosolids
are
produced
and
used
for
land
application.
Depicted
on
the
left
side
of
the
figure
are
opportunities
for
conducting
environmental
hazard
surveillance.
At
these
stages,
biosolids
or
environmental
samples
should
be
collected
and
analyzed
to
verify
that
(
1)
treatment
technologies
for
pathogen
control
are
effective
(
quality
control),
(
2)
chemical
standards
are
met
(
compliance
audits),
and
(
3)
unanticipated
hazards
are
identified.
An
important
part
of
this
verification
process
is
a
review
of
the
management
practices
required
for
land
application,
because
the
practices
are
predicated
on
the
assumption
that
exposure
to
hazardous
agents
is
further
reduced
by
the
implementation
of
such
practices.
Studies
should
be
conducted
to
determine
whether
the
management
practices
specified
in
the
Part
503
rule
achieve
their
intended
effect.
Additional
riskmanagement
practices
should
be
considered
in
revising
the
Part
503
rule.
Considerations
should
include
setbacks
to
residences
or
businesses,
setbacks
to
private
and
public
water
supplies,
limitations
on
holding
or
storage
practices,
slope
restrictions,
soil
permeability
and
depth
to
groundwater
or
bedrock,
and
greater
distance
to
surface
water.
Biosolids
Management
Regulatory
Activities
CH2­
1.
EPA
should
strengthen
its
biosolids­
oversight
program
by
increasing
the
amount
of
funding
and
staff
(
technical
and
administrative)
devoted
to
it.
Biosolids
Management
CH2­
2.
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.
Biosolids
Management
CH2­
3.
Resources
are
also
needed
for
conducting
research
into
emerging
issues
and
to
revise
the
regulations
as
appropriate
and
in
a
timely
fashion
(
e.
g.,
molybdenum
standards
should
be
proposed).
Biosolids
Management
Regulatory
Activities
CH2­
4.
A
process
should
be
established
to
track
allegations
and
sentinel
events
(
compliance,
management,
or
health
based),
investigations,
and
conclusions.
Such
tracking
should
be
systematic,
developed
in
cooperation
with
states,
and
document
both
positive
and
negative
outcomes.
Biosolids
Management
CH4­
3.
In
making
revisions
to
the
Part
503
rule
risk
assessment,
EPA
must
strike
a
balance
between
expending
resources
to
carry
out
site­
specific
data
collection
and
expending
resources
to
model
and
assess
risk
using
existing
information.
In
light
of
improvements
in
exposure
and
health
monitoring,
the
committee
encourages
EPA
to
consider
options
carefully
for
collecting
new
data
in
support
of
risk­
assessment
assumptions
before
resorting
to
another
risk
assessment
that
relies
only
on
existing
data,
models,
and
default
assumptions.
Among
the
data
that
would
be
of
value
are
data
on
proximity
of
receptors
to
land­
application
sites;
surveys
of
activities
that
could
increase
direct
and
indirect
exposures;
and
samples
of
biosolids,
air,
vegetation,
runoff,
groundwater,
and
soil
in
environments
surrounding
land­
application
sites.
In
addition,
EPA
should
conduct
site­
specific
surveys
of
performance
(
e.
g.,
monitor
the
extent
to
which
rates
and
depth
of
application
are
consistent
with
risk­
assessment
assumptions)
and
scientifically
relevant
studies
of
health
complaints.
Biosolids
Management
Risk
Assessment
USEPA
2002a
9
CH7­
1.
Figure
7­
1
should
be
used
by
EPA
as
a
framework
for
managing
the
risks
from
exposure
to
biosolids.
The
framework
includes
audits
of
treatment­
process
performance
and
management
practices,
periodic
hazard
surveillance,
and
studies
of
health
outcomes,
including
preplanned
studies
and
studies
in
response
to
episodic
events.
For
example,
as
recommended
in
Chapters
2
and
6,
surveys
should
be
conducted
to
verify
that
Class
A
and
Class
B
treatment
processes
perform
as
assumed
by
engineering
principles,
and
determinations
of
pathogen
density
and
destruction
across
the
treatment
process
and
in
the
soil
over
time
should
be
completed.
Recommendations
contained
in
Chapter
5
also
address
the
need
for
process­
performance
measures
that
can
be
monitored
and
used
in
site­
specific
surveys
of
performance.
In
Chapter
3,
the
nature
and
objectives
of
hazard
surveillance
studies
and
studies
of
health
outcomes
of
exposed
populations
are
described
more
fully.
All
the
recommendations
reflect
the
committee's
concern
that
the
complex
risk­
assessment
task
posed
by
biosolids
cannot
serve
as
a
useful
and
reliable
guide
without
an
ongoing
effort
to
ensure
that
the
assumptions
underlying
the
assessment
are
valid
and
that
the
risk­
management
procedures
put
in
place
in
response
to
the
assessment
are
being
routinely
implemented.
Broad­
scale
and
sitespecific
feedback,
graphically
depicted
in
Figure
7­
1,
is
needed.
Biosolids
Management
Pathogens
Survey