Document ID: EPA-HQ-OW-2003-0006-0017
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-04-02T05:00Z

Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
the
Environmental
Protection
Agency
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l
i
t
y
g
u
i
d
e
l
i
n
e
s
EPA/
260R­
02­
008
December
2002
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility
and
Integrity
for
Information
Disseminated
by
the
Environmental
Protection
Agency
Prepared
by:

U.
S.
Environmental
Protection
Agency
Office
of
Environmental
Information
(
2810)
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Table
of
Contents
1
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
the
Environmental
Protection
Agency
Table
of
Contents
1
Introduction
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3
2
EPA
Mission
and
Commitment
to
Quality
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5
2.1
EPA's
Mission
and
Commitment
to
Public
Access
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5
2.2
Information
Management
in
EPA
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5
2.3
EPA's
Relationship
with
State,
Tribal,
and
Local
Governments
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3
OMB
Guidelines
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9
4
Existing
Policies
and
Procedures
that
Ensure
and
Maximize
Information
Quality
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10
4.1
Quality
System
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10
4.2
Peer
Review
Policy
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11
4.3
Action
Development
Process
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12
4.4
Integrated
Error
Correction
Process
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12
4.5
Information
Resources
Management
Manual
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13
4.6
Risk
Characterization
Policy
and
Handbook
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13
4.7
Program­
Specific
Policies
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13
4.8
EPA
Commitment
to
Continuous
Improvement
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14
4.9
Summary
of
New
Activities
and
Initiatives
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14
5
Guidelines
Scope
and
Applicability
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15
5.1
What
is
"
Quality"
According
to
the
Guidelines?
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15
5.2
What
is
the
Purpose
of
these
Guidelines?
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15
5.3
When
Do
these
Guidelines
Apply?
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15
5.4
What
is
Not
Covered
by
these
Guidelines?
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16
5.5
What
Happens
if
Information
is
Initially
Not
Covered
by
these
Guidelines,
but
EPA
Subsequently
Disseminates
it
to
the
Public?
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18
5.6
How
does
EPA
Ensure
the
Objectivity,
Utility,
and
Integrity
of
information
that
is
not
covered
by
these
Guidelines?
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18
6
Guidelines
for
Ensuring
and
Maximizing
Information
Quality
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19
6.1
How
does
EPA
Ensure
and
Maximize
the
Quality
of
Disseminated
Information?
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19
6.2
How
Does
EPA
Define
Influential
Information
for
these
Guidelines?
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19
6.3
How
Does
EPA
Ensure
and
Maximize
the
Quality
of
"
Influential"
Information?
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20
6.4
How
Does
EPA
Ensure
and
Maximize
the
Quality
of
"
Influential"
Scientific
Risk
Assessment
Information?
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21
6.5
Does
EPA
Ensure
and
Maximize
the
Quality
of
Information
from
External
Sources?
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28
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Table
of
Contents
2
7
Administrative
Mechanism
for
Pre­
dissemination
Review
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29
7.1
What
are
the
Administrative
Mechanisms
for
Pre­
dissemination
Reviews?
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29
8
Administrative
Mechanisms
for
Correction
of
Information
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30
8.1
What
are
EPA's
Administrative
Mechanisms
for
Affected
Persons
to
Seek
and
Obtain
Correction
of
Information?
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30
8.2
What
Should
be
Included
in
a
Request
for
Correction
of
Information?
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30
8.3
When
Does
EPA
Intend
to
Consider
a
Request
for
Correction
of
Information?
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31
8.4
How
Does
EPA
Intend
to
Respond
to
a
Request
for
Correction
of
Information?
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31
8.5
How
Does
EPA
Expect
to
Process
Requests
for
Correction
of
Information
on
Which
EPA
has
Sought
Public
Comment?
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32
8.6
What
Should
be
Included
in
a
Request
Asking
EPA
to
Reconsider
its
Decision
on
a
Request
for
the
Correction
of
Information?
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34
8.7
How
Does
EPA
Intend
to
Process
Requests
for
Reconsideration
of
EPA
Decisions?
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34
Appendix
A:
IQG
Development
Process
and
Discussion
of
Public
Comments
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36
A.
1
Introduction
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36
A.
2
General
Summary
of
Comments
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37
A.
3
Response
to
Comments
by
Guidelines
Topic
Area
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38
A.
3.1
Existing
Policy
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38
A.
3.2
Scope
and
Applicability
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39
A.
3.3
Sources
of
Information
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42
A.
3.4
Influential
Information
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43
A.
3.5
Reproducibility
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47
A.
3.6
Influential
Risk
Assessment
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48
A.
3.7
Complaint
Resolution
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53
A.
4
Next
Steps
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56
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
1Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
Federal
Agencies,
OMB,
2002.
(
67
FR
8452)
Herein
after
"
OMB
guidelines".
http://
www.
whitehouse.
gov/
omb/
fedreg/
reproducible2.
pdf
Introduction
3
1
Introduction
The
Environmental
Protection
Agency
(
EPA)
is
committed
to
providing
public
access
to
environmental
information.
This
commitment
is
integral
to
our
mission
to
protect
human
health
and
the
environment.
One
of
our
goals
is
that
all
parts
of
society
­
including
communities,
individuals,
businesses,
State
and
local
governments,
Tribal
governments
­
have
access
to
accurate
information
sufficient
to
effectively
participate
in
managing
human
health
and
environmental
risks.
To
fulfill
this
and
other
important
goals,
EPA
must
rely
upon
information
of
appropriate
quality
for
each
decision
we
make.

Developed
in
response
to
guidelines
issued
by
the
Office
of
Management
and
Budget
(
OMB)
1
under
Section
515(
a)
of
the
Treasury
and
General
Government
Appropriations
Act
for
Fiscal
Year
2001
(
Public
Law
106­
554;
H.
R.
5658),
the
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
the
Environmental
Protection
Agency
(
the
Guidelines)
contain
EPA's
policy
and
procedural
guidance
for
ensuring
and
maximizing
the
quality
of
information
we
disseminate.
The
Guidelines
also
outline
administrative
mechanisms
for
EPA
pre­
dissemination
review
of
information
products
and
describe
some
new
mechanisms
to
enable
affected
persons
to
seek
and
obtain
corrections
from
EPA
regarding
disseminated
information
that
they
believe
does
not
comply
with
EPA
or
OMB
guidelines.
Beyond
policies
and
procedures
these
Guidelines
also
incorporate
the
following
performance
goals:

°
Disseminated
information
should
adhere
to
a
basic
standard
of
quality,
including
objectivity,
utility,
and
integrity.

°
The
principles
of
information
quality
should
be
integrated
into
each
step
of
EPA's
development
of
information,
including
creation,
collection,
maintenance,
and
dissemination.

°
Administrative
mechanisms
for
correction
should
be
flexible,
appropriate
to
the
nature
and
timeliness
of
the
disseminated
information,
and
incorporated
into
EPA's
information
resources
management
and
administrative
practices.

OMB
encourages
agencies
to
incorporate
standards
and
procedures
into
existing
information
resources
management
practices
rather
than
create
new,
potentially
duplicative
processes.
EPA
has
taken
this
advice
and
relies
on
numerous
existing
quality­
related
policies
in
these
Guidelines.
EPA
will
work
to
ensure
seamless
implementation
into
existing
practices.
It
is
expected
that
EPA
managers
and
staff
will
familiarize
themselves
with
these
Guidelines,
and
will
carefully
review
existing
program
policies
and
procedures
in
order
to
accommodate
the
principles
outlined
in
this
document.
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Introduction
4
EPA's
Guidelines
are
intended
to
carry
out
OMB's
government­
wide
policy
regarding
information
we
disseminate
to
the
public.
Our
Guidelines
reflect
EPA's
best
effort
to
present
our
goals
and
commitments
for
ensuring
and
maximizing
the
quality
of
information
we
disseminate.
As
such,
they
are
not
a
regulation
and
do
not
change
or
substitute
for
any
legal
requirements.
They
provide
non­
binding
policy
and
procedural
guidance,
and
are
therefore
not
intended
to
create
legal
rights,
impose
legally
binding
requirements
or
obligations
on
EPA
or
the
public
when
applied
in
particular
situations,
or
change
or
impact
the
status
of
information
we
disseminate,
nor
to
contravene
any
other
legal
requirements
that
may
apply
to
particular
agency
determinations
or
other
actions.
EPA's
intention
is
to
fully
implement
these
Guidelines
in
order
to
achieve
the
purposes
of
Section
515.

These
Guidelines
are
the
product
of
an
open,
collaborative
process
between
EPA
and
numerous
EPA
stakeholders.
The
Guidelines
development
process
is
described
in
the
Appendix
to
this
document.
EPA
received
many
public
comments
and
has
addressed
most
comments
in
these
Guidelines.
A
discussion
of
public
comments
is
also
provided
in
the
Appendix
and
is
grouped
by
overarching
themes
and
comments
by
Guidelines
topic
areas.
EPA
views
these
Guidelines
as
a
living
document,
and
anticipates
their
revision
as
we
work
to
further
ensure
and
maximize
information
quality.
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
EPA
Mission
and
Commitment
to
Quality
5
2
EPA
Mission
and
Commitment
to
Quality
2.1
EPA's
Mission
and
Commitment
to
Public
Access
The
mission
of
the
EPA
is
to
protect
human
health
and
safeguard
the
natural
environment
upon
which
life
depends.
EPA
is
committed
to
making
America's
air
cleaner,
water
purer,
and
land
better
protected
and
to
work
closely
with
its
Federal,
State,
Tribal,
and
local
government
partners;
with
citizens;
and
with
the
regulated
community
to
accomplish
its
mission.
In
addition,
the
United
States
plays
a
leadership
role
in
working
with
other
nations
to
protect
the
global
environment.

EPA's
commitment
to
expanding
and
enhancing
access
to
environmental
information
is
articulated
in
our
Strategic
Plan.
EPA
works
every
day
to
expand
the
public's
right
to
know
about
and
understand
their
environment
by
providing
and
facilitating
access
to
a
wealth
of
information
about
public
health
and
local
environmental
issues
and
conditions.
This
enhances
citizen
understanding
and
involvement
and
provides
people
with
tools
to
protect
their
families
and
their
communities.

EPA
statutory
responsibilities
to
protect
human
health
and
safeguard
the
natural
environment
are
described
in
the
statutes
that
mandate
and
govern
our
programs.
EPA
manages
those
programs
in
concert
with
numerous
other
government
and
private
sector
partners.
As
Congress
intended,
each
statute
provides
regulatory
expectations
including
information
quality
considerations
and
principles.
Some
statutes
are
more
specific
than
others,
but
overall,
each
directs
EPA
and
other
agencies
in
how
we
regulate
to
protect
human
health
and
the
environment.
For
example,
the
Safe
Drinking
Water
Act
(
SDWA)
Amendments
of
1996
set
forth
certain
quality
principles
for
how
EPA
should
conduct
human
health
risk
assessments
and
characterize
the
potential
risks
to
humans
from
drinking
water
contaminants.
Information
quality
is
a
key
component
of
every
statute
that
governs
our
mission.

2.2
Information
Management
in
EPA
The
collection,
use,
and
dissemination
of
information
of
known
and
appropriate
quality
are
integral
to
ensuring
that
EPA
achieves
its
mission.
Information
about
human
health
and
the
environment
­­
environmental
characteristics;
physical,
chemical,
and
biological
processes;
and
chemical
and
other
pollutants
­­
underlies
all
environmental
management
and
health
protection
decisions.
The
availability
of,
and
access
to,
information
and
the
analytical
tools
to
understand
it
are
essential
for
assessing
environmental
and
human
health
risks,
designing
appropriate
and
cost­
effective
policies
and
response
strategies,
and
measuring
environmental
improvements.

EPA
works
every
day
to
ensure
information
quality,
but
we
do
not
wait
until
the
point
of
dissemination
to
consider
important
quality
principles.
While
the
final
review
of
a
document
before
it
is
published
is
very
important
to
ensuring
a
product
of
high
quality,
we
know
that
in
order
to
maximize
quality,
we
must
start
much
earlier.
When
you
read
an
EPA
report
at
your
local
library
or
view
EPA
information
on
our
web
site,
that
information
is
the
result
of
processes
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
EPA
Mission
and
Commitment
to
Quality
6
undertaken
by
EPA
and
our
partners
that
assured
quality
along
each
step
of
the
way.
To
better
describe
this
interrelated
information
quality
process,
the
following
presents
some
of
the
major
roles
that
EPA
plays
in
its
effort
to
ensure
and
maximize
the
quality
of
the
information:

°
EPA
is
a
collector
and
generator
of
information:
While
most
of
our
programs
rely
on
States,
Tribes,
or
the
private
sector
to
collect
and
report
information
to
EPA,
there
are
some
programs
in
which
EPA
collects
its
own
information.
One
example
is
the
Agency's
enforcement
and
compliance
program,
under
which
EPA
collects
samples
in
the
field
or
conducts
onsite
inspections.
We
also
conduct
original,
scientific
research
at
headquarters,
in
Regional
Offices,
and
at
our
research
laboratories
to
investigate
and
better
understand
how
our
environment
works,
how
humans
react
to
chemical
pollutants
and
other
environmental
contaminants,
and
how
to
model
our
natural
environment
to
assess
the
potential
impact
of
environmental
management
activities.
Ensuring
the
quality
of
collected
information
is
central
to
our
mission.

°
EPA
is
a
recipient
of
information:
EPA
receives
a
large
amount
of
information
that
external
parties
volunteer
or
provide
under
statutory
and
other
mandates.
Much
of
the
environmental
information
submitted
to
EPA
is
processed
and
stored
in
Agency
information
management
systems.
While,
we
work
to
ensure
and
maximize
the
integrity
of
that
information
through
a
variety
of
mechanisms
and
policies,
we
have
varying
levels
of
quality
controls
over
information
developed
or
collected
by
outside
parties.
This
information
generally
falls
into
one
of
four
categories:

Information
collected
through
contracts
with
EPA.
Examples
of
this
information
include
studies
and
collection
and
analysis
of
data
by
parties
that
are
under
a
contractual
obligation
with
EPA.
Since
EPA
is
responsible
for
managing
the
work
assigned
to
contractors,
EPA
has
a
relatively
high
degree
of
control
over
the
quality
of
this
information.

Information
collected
through
grants
and
cooperative
agreements
with
EPA.
Examples
of
this
information
include
scientific
studies
that
are
performed
under
research
grants
and
data
collected
by
State
agencies
or
other
grantees
to
assess
regulatory
compliance
or
environmental
trends.
Although
EPA
has
less
control
over
grantees
than
contractors,
EPA
can
and
does
include
conditions
in
grants
and
cooperative
agreements
requiring
recipients
to
meet
certain
criteria.

Information
submitted
to
EPA
as
part
of
a
requirement
under
a
statute,
regulation,
permit,
order
or
other
mandate.
Examples
of
this
information
include
required
test
data
for
pesticides
or
chemicals,
Toxics
Release
Inventory
(
TRI)
submissions
and
compliance
information
submitted
to
EPA
by
States
and
the
regulated
community.
EPA
ensures
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
EPA
Mission
and
Commitment
to
Quality
7
quality
control
of
such
information
through
regulatory
requirements,
such
as
requiring
samples
to
be
analyzed
by
specific
analytical
procedures
and
by
certified
laboratories.
However,
each
EPA
program
has
specific
statutory
authorities
which
may
affect
its
ability
to
impose
certain
quality
practices.

The
final
category
of
information
that
is
not
included
in
any
of
the
above
three
categories
includes
information
that
is
either
voluntarily
submitted
to
EPA
in
hopes
of
influencing
a
decision
or
that
EPA
obtains
for
use
in
developing
a
policy,
regulatory,
or
other
decision.
Examples
of
this
information
include
scientific
studies
published
in
journal
articles
and
test
data
obtained
from
other
Federal
agencies,
industry,
and
others.
EPA
may
not
have
any
financial
ties
or
regulatory
requirements
to
control
the
quality
of
this
type
of
information.

While
the
quality
of
information
submitted
to
EPA
is
the
responsibility
of
the
original
collector
of
the
information,
we
nevertheless
maintain
a
robust
quality
system,
that
addresses
information
related
to
the
first
three
bullets
above
by
including
regulatory
requirements
for
quality
assurance
for
EPA
contracts,
grants,
and
assistance
agreements.
For
the
fourth
category,
we
intend
to
develop
and
publish
factors
that
EPA
would
use
in
the
future
to
assess
the
quality
of
voluntary
submissions
or
information
that
the
Agency
gathers
for
its
own
use.

°
EPA
is
a
user
of
information:
Upon
placement
in
our
information
management
systems,
information
becomes
available
for
use
by
many
people
and
systems.
EPA
users
may
include
Program
managers,
information
product
developers,
or
automated
financial
tracking
systems.
Depending
on
the
extent
of
public
release,
users
may
also
include
city
planners,
homeowners,
teachers,
engineers,
or
community
activists,
to
name
a
few.
To
satisfy
this
broad
spectrum
of
users,
it
is
critical
that
we
present
information
in
an
unbiased
context
with
thorough
documentation.

EPA
is
moving
beyond
routine
administration
of
regulatory
information
and
working
in
concert
with
States
and
other
stakeholders
to
provide
new
information
products
that
are
responsive
to
identified
users.
Increasingly,
information
products
are
derived
from
information
originally
collected
to
support
State
or
Federal
regulatory
programs
or
management
activities.
Assuring
the
suitability
of
this
information
for
new
applications
is
of
paramount
importance.

°
EPA
is
a
conduit
for
information:
Another
major
role
that
EPA
plays
in
the
management
of
information
is
as
a
provider
of
public
access.
Such
access
enables
public
involvement
in
how
EPA
achieves
it
mission.
We
provide
access
to
a
variety
of
information
holdings.
Some
information
distributed
by
EPA
includes
information
collected
through
contracts;
information
collected
through
grants
and
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
EPA
Mission
and
Commitment
to
Quality
8
cooperative
agreements;
information
submitted
to
EPA
as
part
of
a
requirement
under
a
statute,
regulation,
permit,
order,
or
other
mandate;
and
information
that
is
either
voluntarily
submitted
to
EPA
in
hopes
of
influencing
a
decision
or
that
EPA
obtains
for
use
in
developing
a
policy,
regulatory,
or
other
decision.
In
some
cases,
EPA
serves
as
an
important
conduit
for
information
generated
by
external
parties;
however,
the
quality
of
that
information
is
the
responsibility
of
the
external
information
developer,
unless
EPA
endorses
or
adopts
it.

2.3
EPA's
Relationship
with
State,
Tribal,
and
Local
Governments
As
mentioned
in
the
previous
section,
EPA
works
with
a
variety
of
partners
to
achieve
its
mission.
Our
key
government
partners
not
only
provide
information,
they
also
work
with
EPA
to
manage
and
implement
programs
and
communicate
with
the
public
about
issues
of
concern.
In
addition
to
implementing
national
programs
through
EPA
Headquarters
Program
Offices,
a
vast
network
of
EPA
Regions
and
other
Federal,
State,
Tribal
and
local
governments
implement
both
mandated
and
voluntary
programs.
This
same
network
collects,
uses,
and
distributes
a
wide
range
of
information.
EPA
plans
to
coordinate
with
these
partners
to
ensure
the
Guidelines
are
appropriate
and
effective.

One
major
mechanism
to
ensure
and
maximize
information
integrity
is
the
National
Environmental
Information
Exchange
Network
(
NEIEN,
or
Network).
The
result
of
an
important
partnership
between
EPA,
States
and
Tribal
governments,
the
Network
seeks
to
enhance
the
Agency's
information
architecture
to
ensure
timely
and
one­
stop
reporting
from
many
of
EPA's
information
partners.
Key
components
include
the
establishment
of
the
Central
Data
Exchange
(
CDX)
portal
and
a
System
of
Access
for
internal
and
external
users.
When
fully
implemented,
the
Network
and
its
many
components
will
enhance
EPA
and
the
public's
ability
to
access,
use,
and
integrate
information
and
the
ability
of
external
providers
to
report
to
EPA.
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
OMB
Guidelines
9
3
OMB
Guidelines
In
Section
515(
a)
of
the
Treasury
and
General
Government
Appropriations
Act
for
Fiscal
Year
2001
(
Public
Law
106­
554;
H.
R.
5658),
Congress
directed
OMB
to
issue
government­
wide
guidelines
that
"
provide
policy
and
procedural
guidance
to
Federal
agencies
for
ensuring
and
maximizing
the
quality,
objectivity,
utility,
and
integrity
of
information
(
including
statistical
information)
disseminated
by
Federal
agencies...."
The
OMB
guidelines
direct
agencies
subject
to
the
Paperwork
Reduction
Act
(
44
U.
S.
C.
3502(
1))
to:

°
Issue
their
own
information
quality
guidelines
to
ensure
and
maximize
the
quality,
objectivity,
utility,
and
integrity
of
information,
including
statistical
information,
by
no
later
than
one
year
after
the
date
of
issuance
of
the
OMB
guidelines;

°
Establish
administrative
mechanisms
allowing
affected
persons
to
seek
and
obtain
correction
of
information
maintained
and
disseminated
by
the
agency
that
does
not
comply
with
the
OMB
or
agency
guidelines;
and
°
Report
to
the
Director
of
OMB
the
number
and
nature
of
complaints
received
by
the
agency
regarding
agency
compliance
with
OMB
guidelines
concerning
the
quality,
objectivity,
utility,
and
integrity
of
information
and
how
such
complaints
were
resolved.

The
OMB
guidelines
provide
some
basic
principles
for
agencies
to
consider
when
developing
their
own
guidelines
including:

°
Guidelines
should
be
flexible
enough
to
address
all
communication
media
and
variety
of
scope
and
importance
of
information
products.

°
Some
agency
information
may
need
to
meet
higher
or
more
specific
expectations
for
objectivity,
utility,
and
integrity.
Information
of
greater
importance
should
be
held
to
a
higher
quality
standard.

°
Ensuring
and
maximizing
quality,
objectivity,
utility,
and
integrity
comes
at
a
cost,
so
agencies
should
use
an
approach
that
weighs
the
costs
and
benefits
of
higher
information
quality.

°
Agencies
should
adopt
a
common
sense
approach
that
builds
on
existing
processes
and
procedures.
It
is
important
that
agency
guidelines
do
not
impose
unnecessary
administrative
burdens
or
inhibit
agencies
from
disseminating
quality
information
to
the
public.
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
2
http://
cfpub.
epa.
gov/
ncea/
cfm/
partmatt.
cfm
3
http://
www.
epa.
gov/
enviro/
wme/

4
http://
www.
epa.
gov/
kids
5
EPA
Quality
Manual
for
Environmental
Programs
5360
A1.
May
2000.
http://
www.
epa.
gov/
quality/
qs­
docs/
5360.
pdf
Existing
Policies
and
Procedures
that
Ensure
and
Maximize
Information
Quality
10
4
Existing
Policies
and
Procedures
that
Ensure
and
Maximize
Information
Quality
EPA
is
dedicated
to
the
collection,
generation,
and
dissemination
of
high
quality
information.
We
disseminate
a
wide
variety
of
information
products,
ranging
from
comprehensive
scientific
assessments
of
potential
health
risks,
2
to
web­
based
applications
that
provide
compliance
information
and
map
the
location
of
regulated
entities,
3
to
simple
fact
sheets
for
school
children.
4
As
a
result
of
this
diversity
of
information­
related
products
and
practices,
different
EPA
programs
have
evolved
specialized
approaches
to
information
quality
assurance.
The
OMB
guidelines
encourage
agencies
to
avoid
the
creation
of
"
new
and
potentially
duplicative
or
contradictory
processes."
Further,
OMB
stresses
that
its
guidelines
are
not
intended
to
"
impose
unnecessary
administrative
burdens
that
would
inhibit
agencies
from
continuing
to
take
advantage
of
the
Internet
and
other
technologies
to
disseminate
information
that
can
be
of
great
benefit
and
value
to
the
public."
In
this
spirit,
EPA
seeks
to
foster
the
continuous
improvement
of
existing
information
quality
activities
and
programs.
In
implementing
these
guidelines,
we
note
that
ensuring
the
quality
of
information
is
a
key
objective
alongside
other
EPA
objectives,
such
as
ensuring
the
success
of
Agency
missions,
observing
budget
and
resource
priorities
and
restraints,
and
providing
useful
information
to
the
public.
EPA
intends
to
implement
these
Guidelines
in
a
way
that
will
achieve
all
these
objectives
in
a
harmonious
way
in
conjunction
with
our
existing
guidelines
and
policies,
some
of
which
are
outlined
below.
These
examples
illustrate
some
of
the
numerous
systems
and
practices
in
place
that
address
the
quality,
objectivity,
utility,
and
integrity
of
information.

4.1
Quality
System
The
EPA
Agency­
wide
Quality
System
helps
ensure
that
EPA
organizations
maximize
the
quality
of
environmental
information,
including
information
disseminated
by
the
Agency.
A
graded
approach
is
used
to
establish
quality
criteria
that
are
appropriate
for
the
intended
use
of
the
information
and
the
resources
available.
The
Quality
System
is
documented
in
EPA
Order
5360.1
A2,
"
Policy
and
Program
Requirements
for
the
Mandatory
Agency­
wide
Quality
System"
and
the
"
EPA
Quality
Manual."
5
To
implement
the
Quality
System,
EPA
organizations
(
1)
assign
a
quality
assurance
manager,
or
person
assigned
to
an
equivalent
position,
who
has
sufficient
technical
and
management
expertise
and
authority
to
conduct
independent
oversight
of
the
implementation
of
the
organization's
quality
system;
(
2)
develop
a
Quality
Management
Plan,
which
documents
the
organization's
quality
system;
(
3)
conduct
an
annual
assessment
of
the
organization's
quality
system;
(
4)
use
a
systematic
planning
process
to
develop
acceptance
or
performance
criteria
prior
to
the
initiation
of
all
projects
that
involve
environmental
information
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
6Peer
Review
and
Peer
Involvement
at
the
U.
S.
EPA.
June
7,
1994.
http://
www.
epa.
gov/
osp/
spc/
perevmem.
htm
7Peer
Review
Handbook,
2nd
Edition,
U.
S.
EPA,
Science
Policy
Council,
December
2000,
EPA
100­
B­
00­
001.
http://
www.
epa.
gov/
osp/
spc/
prhandbk.
pdf
Existing
Policies
and
Procedures
that
Ensure
and
Maximize
Information
Quality
11
collection
and/
or
use;
(
5)
develop
Quality
Assurance
Project
Plan(
s),
or
equivalent
document(
s)
for
all
applicable
projects
and
tasks
involving
environmental
data;
(
6)
conduct
an
assessment
of
existing
data,
when
used
to
support
Agency
decisions
or
other
secondary
purposes,
to
verify
that
they
are
of
sufficient
quantity
and
adequate
quality
for
their
intended
use;
(
7)
implement
all
Agency­
wide
Quality
System
components
in
all
applicable
EPA­
funded
extramural
agreements;
and
(
8)
provide
appropriate
training,
for
all
levels
of
management
and
staff.

The
EPA
Quality
System
may
also
apply
to
non­
EPA
organizations,
with
key
principles
incorporated
in
the
applicable
regulations
governing
contracts,
grants,
and
cooperative
agreements.
EPA
Quality
System
provisions
may
also
be
invoked
as
part
of
negotiated
agreements
such
as
memoranda
of
understanding.
Non­
EPA
organizations
that
may
be
subject
to
EPA
Quality
System
requirements
include
(
a)
any
organization
or
individual
under
direct
contract
to
EPA
to
furnish
services
or
items
or
perform
work
(
i.
e.,
a
contractor)
under
the
authority
of
48
CFR
part
46,
(
including
applicable
work
assignments,
delivery
orders,
and
task
orders);
and
(
b)
other
government
agencies
receiving
assistance
from
EPA
through
interagency
agreements.
Separate
quality
assurance
requirements
for
assistance
recipients
are
set
forth
in
40
CFR
part
30
(
governing
assistance
agreements
with
institutions
of
higher
education,
hospitals,
and
other
non­
profit
recipients
of
financial
assistance)
and
40
CFR
parts
31
and
35
(
government
assistance
agreements
with
State,
Tribal,
and
local
governments).

4.2
Peer
Review
Policy
In
addition
to
the
Quality
System,
EPA's
Peer
Review
Policy
provides
that
major
scientifically
and
technically
based
work
products
(
including
scientific,
engineering,
economic,
or
statistical
documents)
related
to
Agency
decisions
should
be
peer­
reviewed.
Agency
managers
within
Headquarters,
Regions,
laboratories,
and
field
offices
determine
and
are
accountable
for
the
decision
whether
to
employ
peer
review
in
particular
instances
and,
if
so,
its
character,
scope,
and
timing.
These
decisions
are
made
consistent
with
program
goals
and
priorities,
resource
constraints,
and
statutory
or
court­
ordered
deadlines.
For
those
work
products
that
are
intended
to
support
the
most
important
decisions
or
that
have
special
importance
in
their
own
right,
external
peer
review
is
the
procedure
of
choice.
For
other
work
products,
internal
peer
review
is
an
acceptable
alternative
to
external
peer
review.
Peer
review
is
not
restricted
to
the
penultimate
version
of
work
products;
in
fact,
peer
review
at
the
planning
stage
can
often
be
extremely
beneficial.
The
basis
for
EPA
peer
review
policy
is
articulated
in
Peer
Review
and
Peer
Involvement
at
the
U.
S.
Environmental
Protection
Agency.
6
The
Peer
Review
Policy
was
first
issued
in
January,
1993,
and
was
updated
in
June,
1994.
In
addition
to
the
policy,
EPA
has
published
a
Peer
Review
Handbook,
7
which
provides
detailed
guidance
for
implementing
the
policy.
The
handbook
was
last
revised
December,
2000.
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
8Integrated
Error
Correction
Process
for
Environmental
Data.
http://
www.
epa.
gov/
cdx/
iecp.
html
Existing
Policies
and
Procedures
that
Ensure
and
Maximize
Information
Quality
12
4.3
Action
Development
Process
The
Agency's
Action
Development
Process
also
serves
to
ensure
and
maximize
the
quality
of
EPA
disseminated
information.
Top
Agency
actions
and
Economically
Significant
actions
as
designated
under
Executive
Order
12866
are
developed
as
part
of
the
Agency's
Action
Development
Process.
The
Action
Development
Process
ensures
the
early
and
timely
involvement
of
senior
management
at
key
decision
milestones
to
facilitate
the
consideration
of
a
broad
range
of
regulatory
and
non­
regulatory
options
and
analytic
approaches.
Of
particular
importance
to
the
Action
Development
Process
is
ensuring
that
our
scientists,
economists,
and
others
with
technical
expertise
are
appropriately
involved
in
determining
needed
analyses
and
research,
identifying
alternatives,
and
selecting
options.
Program
Offices
and
Regional
Offices
are
invited
to
participate
to
provide
their
unique
perspectives
and
expertise.
Effective
consultation
with
policy
advisors
(
e.
g.,
Senior
Policy
Council,
Science
Policy
Council),
coregulators
(
e.
g.,
States,
Tribes,
and
local
governments),
and
stakeholders
is
also
part
of
the
process.
Final
Agency
Review
(
FAR)
generally
takes
place
before
the
release
of
substantive
information
associated
with
these
actions.
The
FAR
process
ensures
the
consistency
of
any
policy
determinations,
as
well
as
the
quality
of
the
information
underlying
each
policy
determination
and
its
presentation.

4.4
Integrated
Error
Correction
Process
The
Agency's
Integrated
Error
Correction
Process8
(
IECP)
is
a
process
by
which
members
of
the
public
can
notify
EPA
of
a
potential
data
error
in
information
EPA
distributes
or
disseminates.
This
process
builds
on
existing
data
processes
through
which
discrete,
numerical
errors
in
our
data
systems
are
reported
to
EPA.
The
IECP
has
made
these
tools
more
prominent
and
easier
to
use.
Individuals
who
identify
potential
data
errors
on
the
EPA
web
site
can
contact
us
through
the
IECP
by
using
the
"
Report
Error"
button
or
error
correction
hypertext
found
on
major
data
bases
throughout
EPA's
web
site.
EPA
reviews
the
error
notification
and
assists
in
bringing
the
notification
to
resolution
with
those
who
are
responsible
for
the
data
within
or
outside
the
Agency,
as
appropriate.
The
IECP
tracks
this
entire
process
from
notification
through
final
resolution.
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
9
EPA
Directive
2100
Information
Resources
Management
Policy
Manual.
http://
www.
epa.
gov/
irmpoli8/
polman/

10Risk
Characterization
Handbook,
U.
S.
EPA,
Science
Policy
Council,
December
2000.
http://
www.
epa.
gov/
osp/
spc/
2riskchr.
htm
Existing
Policies
and
Procedures
that
Ensure
and
Maximize
Information
Quality
13
4.5
Information
Resources
Management
Manual
The
EPA
Information
Resources
Management
(
IRM)
Manual9
articulates
and
describes
many
of
our
information
development
and
management
procedures
and
policies,
including
information
security,
data
standards,
records
management,
information
collection,
and
library
services.
Especially
important
in
the
context
of
the
Guidelines
provided
in
this
document,
the
IRM
Manual
describes
how
we
maintain
and
ensure
information
integrity.
We
believe
that
maintaining
information
integrity
refers
to
keeping
information
"
unaltered,"
i.
e.,
free
from
unauthorized
or
accidental
modification
or
destruction.
These
integrity
principles
apply
to
all
information.
Inappropriately
changed
or
modified
data
or
software
impacts
information
integrity
and
compromises
the
value
of
the
information
system.
Because
of
the
importance
of
EPA's
information
to
the
decisions
made
by
the
Agency,
its
partners,
and
the
public,
it
is
our
responsibility
to
ensure
that
the
information
is,
and
remains,
accurate
and
credible.

Beyond
addressing
integrity
concerns,
the
IRM
Manual
also
includes
Agency
policy
on
public
access
and
records
management.
These
are
key
chapters
that
enable
EPA
to
ensure
transparency
and
the
reproducibility
of
information.

4.6
Risk
Characterization
Policy
and
Handbook
The
EPA
Risk
Characterization
Policy
and
Handbook10
provide
guidance
for
risk
characterization
that
is
designed
to
ensure
that
critical
information
from
each
stage
of
a
risk
assessment
is
used
in
forming
conclusions
about
risk.
The
Policy
calls
for
a
transparent
process
and
products
that
are
clear,
consistent
and
reasonable.
The
Handbook
is
designed
to
provide
risk
assessors,
risk
managers,
and
other
decision­
makers
an
understanding
of
the
goals
and
principles
of
risk
characterization.

4.7
Program­
Specific
Policies
We
mentioned
just
a
few
of
the
Agency's
major
policies
that
ensure
and
maximize
the
quality
of
information
we
disseminate.
In
addition
to
these
Agency­
wide
systems
and
procedures,
Program
Offices
and
Regions
implement
many
Office­
level
and
program­
specific
procedures
to
ensure
and
maximize
information
quality.
The
purpose
of
these
Guidelines
is
to
serve
as
a
common
thread
that
ties
all
these
policies
together
under
the
topics
provided
by
OMB:
objectivity,
integrity
and
utility.
EPA's
approach
to
ensuring
and
maximizing
quality
is
necessarily
distributed
across
all
levels
of
EPA's
organizational
hierarchy,
including
Offices,
Regions,
divisions,
projects,
and
even
products.
Oftentimes,
there
are
different
quality
considerations
for
different
types
of
products.
For
example,
the
quality
principles
associated
with
a
risk
assessment
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Existing
Policies
and
Procedures
that
Ensure
and
Maximize
Information
Quality
14
differ
from
those
associated
with
developing
a
new
model.
The
Agency
currently
has
a
comprehensive
but
distributed
system
of
policies
to
address
such
unique
quality
considerations.
These
Guidelines
provide
us
with
a
mechanism
to
help
coordinate
and
synthesize
our
quality
policies
and
procedures.

4.8
EPA
Commitment
to
Continuous
Improvement
As
suggested
above,
we
will
continue
to
work
to
ensure
that
our
many
policies
and
procedures
are
appropriately
implemented,
synthesized,
and
revised
as
needed.
One
way
to
build
on
achievements
and
learn
from
mistakes
is
to
document
lessons
learned
about
specific
activities
or
products.
For
example,
the
documents
that
present
guidance
and
tools
for
implementing
the
Quality
System
are
routinely
subjected
to
external
peer
review
during
their
development;
comments
from
the
reviewers
are
addressed
and
responses
reviewed
by
management
before
the
document
is
issued.
Each
document
is
formally
reviewed
every
five
years
and
is
either
reissued,
revised
as
needed,
or
rescinded.
If
important
new
information
or
approaches
evolve
between
reviews,
the
document
may
be
reviewed
and
revised
more
frequently.

4.9
Summary
of
New
Activities
and
Initiatives
In
response
to
OMB's
guidelines,
EPA
recognizes
that
it
will
be
incorporating
new
policies
and
administrative
mechanisms.
As
we
reaffirm
our
commitment
to
our
existing
policies
and
procedures
that
ensure
and
maximize
quality,
we
also
plan
to
address
the
following
new
areas
of
focus
and
commitment:

°
Working
with
the
public
to
develop
assessment
factors
that
we
will
use
to
assess
the
quality
of
information
developed
by
external
parties,
prior
to
EPA's
use
of
that
information.

°
Affirming
a
new
commitment
to
information
quality,
especially
the
transparency
of
information
products.

°
Establishing
Agency­
wide
correction
process
and
request
for
reconsideration
panel
to
provide
a
centralized
point
of
access
for
all
affected
parties
to
seek
and
obtain
the
correction
of
disseminated
information
that
they
believe
does
not
conform
to
these
Guidelines
or
the
OMB
guidelines.
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Guidelines
Scope
and
Applicability
15
5
Guidelines
Scope
and
Applicability
5.1
What
is
"
Quality"
According
to
the
Guidelines?

Consistent
with
the
OMB
guidelines,
EPA
is
issuing
these
Guidelines
to
ensure
and
maximize
the
quality,
including
objectivity,
utility
and
integrity,
of
disseminated
information.
Objectivity,
integrity,
and
utility
are
defined
here,
consistent
with
the
OMB
guidelines.
"
Objectivity"
focuses
on
whether
the
disseminated
information
is
being
presented
in
an
accurate,
clear,
complete,
and
unbiased
manner,
and
as
a
matter
of
substance,
is
accurate,
reliable,
and
unbiased.
"
Integrity"
refers
to
security,
such
as
the
protection
of
information
from
unauthorized
access
or
revision,
to
ensure
that
the
information
is
not
compromised
through
corruption
or
falsification.
"
Utility"
refers
to
the
usefulness
of
the
information
to
the
intended
users.

5.2
What
is
the
Purpose
of
these
Guidelines?

The
collection,
use,
and
dissemination
of
information
of
known
and
appropriate
quality
is
integral
to
ensuring
that
EPA
achieves
its
mission.
Information
about
the
environment
and
human
health
underlies
all
environmental
management
decisions.
Information
and
the
analytical
tools
to
understand
it
are
essential
for
assessing
environmental
and
human
health
risks,
designing
appropriate
and
cost­
effective
policies
and
response
strategies,
and
measuring
environmental
improvements.

These
Guidelines
describe
EPA's
policy
and
procedures
for
reviewing
and
substantiating
the
quality
of
information
before
EPA
disseminates
it.
They
describe
our
administrative
mechanisms
for
enabling
affected
persons
to
seek
and
obtain,
where
appropriate,
correction
of
information
disseminated
by
EPA
that
they
believe
does
not
comply
with
EPA
or
OMB
guidelines.

5.3
When
Do
these
Guidelines
Apply?

These
Guidelines
apply
to
"
information"
EPA
disseminates
to
the
public.
"
Information,"
for
purposes
of
these
Guidelines,
generally
includes
any
communication
or
representation
of
knowledge
such
as
facts
or
data,
in
any
medium
or
form.
Preliminary
information
EPA
disseminates
to
the
public
is
also
considered
"
information"
for
the
purposes
of
the
Guidelines.
Information
generally
includes
material
that
EPA
disseminates
from
a
web
page.
However
not
all
web
content
is
considered
"
information"
under
these
Guidelines
(
e.
g.,
certain
information
from
outside
sources
that
is
not
adopted,
endorsed,
or
used
by
EPA
to
support
an
Agency
decision
or
position).

For
purposes
of
these
Guidelines,
EPA
disseminates
information
to
the
public
when
EPA
initiates
or
sponsors
the
distribution
of
information
to
the
public.

°
EPA
initiates
a
distribution
of
information
if
EPA
prepares
the
information
and
distributes
it
to
support
or
represent
EPA's
viewpoint,
or
to
formulate
or
support
a
regulation,
guidance,
or
other
Agency
decision
or
position.
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Guidelines
Scope
and
Applicability
16
°
EPA
initiates
a
distribution
of
information
if
EPA
distributes
information
prepared
or
submitted
by
an
outside
party
in
a
manner
that
reasonably
suggests
that
EPA
endorses
or
agrees
with
it;
if
EPA
indicates
in
its
distribution
that
the
information
supports
or
represents
EPA's
viewpoint;
or
if
EPA
in
its
distribution
proposes
to
use
or
uses
the
information
to
formulate
or
support
a
regulation,
guidance,
policy,
or
other
Agency
decision
or
position.

°
Agency­
sponsored
distribution
includes
instances
where
EPA
reviews
and
comments
on
information
distributed
by
an
outside
party
in
a
manner
that
indicates
EPA
is
endorsing
it,
directs
the
outside
party
to
disseminate
it
on
EPA's
behalf,
or
otherwise
adopts
or
endorses
it.

EPA
intends
to
use
notices
to
explain
the
status
of
information,
so
that
users
will
be
aware
of
whether
the
information
is
being
distributed
to
support
or
represent
EPA's
viewpoint.

5.4
What
is
Not
Covered
by
these
Guidelines?

If
an
item
is
not
considered
"
information,"
these
Guidelines
do
not
apply.
Examples
of
items
that
are
not
considered
information
include
Internet
hyperlinks
and
other
references
to
information
distributed
by
others,
and
opinions,
where
EPA's
presentation
makes
it
clear
that
what
is
being
offered
is
someone's
opinion
rather
than
fact
or
EPA's
views.

"
Dissemination"
for
the
purposes
of
these
Guidelines
does
not
include
distributions
of
information
that
EPA
does
not
initiate
or
sponsor.
Below
is
a
sample
of
various
types
of
information
that
would
not
generally
be
considered
disseminated
by
EPA
to
the
public:

°
Distribution
of
information
intended
only
for
government
employees
(
including
intra­
or
interagency
use
or
sharing)
or
recipients
of
government
contracts,
grants,
or
cooperative
agreements.
Intra­
agency
use
of
information
includes
use
of
information
pertaining
to
basic
agency
operations,
such
as
management,
personnel,
and
organizational
information.

°
EPA's
response
to
requests
for
agency
records
under
the
Freedom
of
Information
Act
(
FOIA),
the
Privacy
Act,
the
Federal
Advisory
Committee
Act
(
FACA),
or
other
similar
laws.

°
Distribution
of
information
in
correspondence
directed
to
individuals
or
persons
(
i.
e.,
any
individual,
group,
or
entity,
including
any
government
or
political
subdivision
thereof,
or
Federal
governmental
component/
unit).

°
Information
of
an
ephemeral
nature,
such
as
press
releases,
fact
sheets,
press
conferences,
and
similar
communications,
in
any
medium
that
advises
the
public
of
an
event
or
activity
or
announces
information
EPA
has
disseminated
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Guidelines
Scope
and
Applicability
17
elsewhere;
interviews,
speeches,
and
similar
communications
that
EPA
does
not
disseminate
to
the
public
beyond
their
original
context,
such
as
by
placing
them
on
the
Internet.
If
a
speech,
press
release,
or
other
"
ephemeral"
communication
is
about
an
information
product
disseminated
elsewhere
by
EPA,
the
product
itself
will
be
covered
by
these
Guidelines.

°
Information
presented
to
Congress
as
part
of
the
legislative
or
oversight
processes,
such
as
testimony
of
officials,
information,
or
drafting
assistance
provided
to
Congress
in
connection
with
pending
or
proposed
legislation,
unless
EPA
simultaneously
disseminates
this
information
to
the
public.

°
Background
information
such
as
published
articles
distributed
by
libraries
or
by
other
distribution
methods
that
do
not
imply
that
EPA
has
adopted
or
endorsed
the
materials.
This
includes
outdated
or
superseded
EPA
information
that
is
provided
as
background
information
but
no
longer
reflects
EPA
policy
or
influences
EPA
decisions,
where
the
outdated
or
superseded
nature
of
such
material
is
reasonably
apparent
from
its
form
of
presentation
or
date
of
issuance,
or
where
EPA
indicates
that
the
materials
are
provided
as
background
materials
and
do
not
represent
EPA's
current
view.

°
These
Guidelines
do
not
apply
to
information
distributed
by
recipients
of
EPA
contracts,
grants,
or
cooperative
agreements,
unless
the
information
is
disseminated
on
EPA's
behalf,
as
when
EPA
specifically
directs
or
approves
the
dissemination.
These
Guidelines
do
not
apply
to
the
distribution
of
any
type
of
research
by
Federal
employees
and
recipients
of
EPA
funds,
where
the
researcher
(
not
EPA)
decides
whether
and
how
to
communicate
and
publish
the
research,
does
so
in
the
same
manner
as
his
or
her
academic
colleagues,
and
distributes
the
research
in
a
manner
that
indicates
it
does
not
necessarily
represent
EPA's
official
position
(
for
example,
by
including
an
appropriate
disclaimer).
The
Guidelines
do
not
apply
even
if
EPA
retains
ownership
or
other
intellectual
property
rights
because
the
Federal
government
paid
for
the
research.

°
Distribution
of
information
in
public
filings
to
EPA,
including
information
submitted
to
EPA
by
any
individual
or
person
(
as
discussed
above),
either
voluntarily
or
under
mandates
or
requirements
(
such
as
filings
required
by
statutes,
regulations,
orders,
permits,
or
licenses).
The
Guidelines
do
not
apply
where
EPA
distributes
this
information
simply
to
provide
the
public
with
quicker
and
easier
access
to
materials
submitted
to
EPA
that
are
publicly
available.
This
will
generally
be
the
case
so
long
as
EPA
is
not
the
author,
and
is
not
endorsing,
adopting,
using,
or
proposing
to
use
the
information
to
support
an
Agency
decision
or
position.

°
Distribution
of
information
in
documents
filed
in
or
prepared
specifically
for
a
judicial
case
or
an
administrative
adjudication
and
intended
to
be
limited
to
such
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Guidelines
Scope
and
Applicability
18
actions,
including
information
developed
during
the
conduct
of
any
criminal
or
civil
action
or
administrative
enforcement
action,
investigation,
or
audit
involving
an
agency
against
specific
parties.

5.5
What
Happens
if
Information
is
Initially
Not
Covered
by
these
Guidelines,
but
EPA
Subsequently
Disseminates
it
to
the
Public?

If
a
particular
distribution
of
information
is
not
covered
by
these
Guidelines,
the
Guidelines
may
still
apply
to
a
subsequent
dissemination
of
the
information
in
which
EPA
adopts,
endorses,
or
uses
the
information
to
formulate
or
support
a
regulation,
guidance,
or
other
Agency
decision
or
position.
For
example,
if
EPA
simply
makes
a
public
filing
(
such
as
facility
data
required
by
regulation)
available
to
the
public,
these
Guidelines
would
not
apply
to
that
distribution
of
information.
However,
if
EPA
later
includes
the
information
in
a
background
document
in
support
of
a
rulemaking,
these
Guidelines
would
apply
to
that
later
dissemination
of
the
information
in
that
document.

5.6
How
does
EPA
Ensure
the
Objectivity,
Utility,
and
Integrity
of
information
that
is
not
covered
by
these
Guidelines?

These
Guidelines
apply
only
to
information
EPA
disseminates
to
the
public,
outlined
in
section
5.3,
above.
Other
information
distributed
by
EPA
that
is
not
covered
by
these
Guidelines
is
still
subject
to
all
applicable
EPA
policies,
quality
review
processes,
and
correction
procedures.
These
include
quality
management
plans
for
programs
that
collect,
manage,
and
use
environmental
information,
peer
review,
and
other
procedures
that
are
specific
to
individual
programs
and,
therefore,
not
described
in
these
Guidelines.
It
is
EPA's
policy
that
all
of
the
information
it
distributes
meets
a
basic
standard
of
information
quality,
and
that
its
utility,
objectivity,
and
integrity
be
scaled
and
appropriate
to
the
nature
and
timeliness
of
the
planned
and
anticipated
uses.
Ensuring
the
quality
of
EPA
information
is
not
necessarily
dependent
on
any
plans
to
disseminate
the
information.
EPA
continues
to
produce,
collect,
and
use
information
that
is
of
the
appropriate
quality,
irrespective
of
these
Guidelines
or
the
prospects
for
dissemination
of
the
information.
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
11EPA
Quality
Manual
for
Environmental
Programs
5360
A1.
May
2000.
http://
www.
epa.
gov/
quality/
qs­
docs/
5360.
pdf
12Peer
Review
Handbook,
2nd
Edition,
U.
S.
EPA,
Science
Policy
Council,
December
2000,
EPA
100­
B­
00­
001.
http://
www.
epa.
gov/
osp/
spc/
prhandbk.
pdf
13EPA's
Print
and
Web
Communications
Product
Review
Guide.
http://
www.
epa.
gov/
dced/
pdf/
review.
pdf
14Web
Guide.
U.
S.
EPA.
http://
www.
epa.
gov/
webguide/
resources/
webserv.
html
15Integrated
Error
Correction
Process.
http://
www.
epa.
gov/
cdx/
iecp.
html
16The
term
"
clear
and
substantial
impact"
is
used
as
part
of
a
definition
to
distinguish
different
categories
of
information
for
purposes
of
these
Guidelines.
EPA
does
not
intend
the
classification
of
information
under
this
definition
to
change
or
impact
the
status
of
the
information
in
any
other
setting,
such
as
for
purposes
of
determining
whether
the
dissemination
of
the
information
is
a
final
Agency
action.

Guidelines
for
Ensuring
and
Maximizing
Information
Quality
19
6
Guidelines
for
Ensuring
and
Maximizing
Information
Quality
6.1
How
does
EPA
Ensure
and
Maximize
the
Quality
of
Disseminated
Information?

EPA
ensures
and
maximizes
the
quality
of
the
information
we
disseminate
by
implementing
well
established
policies
and
procedures
within
the
Agency
as
appropriate
to
the
information
product.
There
are
many
tools
that
the
Agency
uses
such
as
the
Quality
System,
11
review
by
senior
management,
peer
review
process,
12
communications
product
review
process,
13
the
web
guide,
14
and
the
error
correction
process.
15
Beyond
our
internal
quality
management
system,
EPA
also
ensures
the
quality
of
information
we
disseminate
by
seeking
input
from
experts
and
the
general
public.
EPA
consults
with
groups
such
as
the
Science
Advisory
Board
and
the
Science
Advisory
Panel,
in
addition
to
seeking
public
input
through
public
comment
periods
and
by
hosting
public
meetings.

For
the
purposes
of
the
Guidelines,
EPA
recognizes
that
if
data
and
analytic
results
are
subjected
to
formal,
independent,
external
peer
review,
the
information
may
generally
be
presumed
to
be
of
acceptable
objectivity.
However,
this
presumption
of
objectivity
is
rebuttable.
The
Agency
uses
a
graded
approach
and
uses
these
tools
to
establish
the
appropriate
quality,
objectivity,
utility,
and
integrity
of
information
products
based
on
the
intended
use
of
the
information
and
the
resources
available.
As
part
of
this
graded
approach,
EPA
recognizes
that
some
of
the
information
it
disseminates
includes
influential
scientific,
financial,
or
statistical
information,
and
that
this
category
should
meet
a
higher
standard
of
quality.

6.2
How
Does
EPA
Define
Influential
Information
for
these
Guidelines?

"
Influential,"
when
used
in
the
phrase
"
influential
scientific,
financial,
or
statistical
information,"
means
that
the
Agency
can
reasonably
determine
that
dissemination
of
the
information
will
have
or
does
have
a
clear
and
substantial
impact
(
i.
e.,
potential
change
or
effect)
on
important
public
policies
or
private
sector
decisions.
16
For
the
purposes
of
the
EPA's
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Guidelines
for
Ensuring
and
Maximizing
Information
Quality
20
Information
Quality
Guidelines,
EPA
will
generally
consider
the
following
classes
of
information
to
be
influential,
and,
to
the
extent
that
they
contain
scientific,
financial,
or
statistical
information,
that
information
should
adhere
to
a
rigorous
standard
of
quality:

°
Information
disseminated
in
support
of
top
Agency
actions
(
i.
e.,
rules,
substantive
notices,
policy
documents,
studies,
guidance)
that
demand
the
ongoing
involvement
of
the
Administrator's
Office
and
extensive
cross­
Agency
involvement;
issues
that
have
the
potential
to
result
in
major
cross­
Agency
or
cross­
media
policies,
are
highly
controversial,
or
provide
a
significant
opportunity
to
advance
the
Administrator's
priorities.
Top
Agency
actions
usually
have
potentially
great
or
widespread
impacts
on
the
private
sector,
the
public
or
state,
local
or
tribal
governments.
This
category
may
also
include
precedent­
setting
or
controversial
scientific
or
economic
issues.

°
Information
disseminated
in
support
of
Economically
Significant
actions
as
defined
in
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993),
Agency
actions
that
are
likely
to
have
an
annual
effect
on
the
economy
of
$
100
million
or
more
or
adversely
affect
in
a
material
way
the
economy,
a
sector
of
the
economy,
productivity,
competition,
jobs,
the
environment,
public
health
or
safety,
or
State,
Tribal,
or
local
governments
or
communities.

°
Major
work
products
undergoing
peer
review
as
called
for
under
the
Agency's
Peer
Review
Policy.
Described
in
the
Science
Policy
Council
Peer
Review
Handbook,
the
EPA
Peer
Review
Policy
regards
major
scientific
and
technical
work
products
as
those
that
have
a
major
impact,
involve
precedential,
novel,
and/
or
controversial
issues,
or
the
Agency
has
a
legal
and/
or
statutory
obligation
to
conduct
a
peer
review.
These
Major
work
products
are
typically
subjected
to
external
peer
review.
Some
products
that
may
not
be
considered
"
major"
under
the
EPA
Peer
Review
Policy
may
be
subjected
to
external
peer
review
but
EPA
does
not
consider
such
products
influential
for
purposes
of
these
Guidelines.

°
Case­
by­
case:
The
Agency
may
make
determinations
of
what
constitutes
"
influential
information"
beyond
those
classes
of
information
already
identified
on
a
case­
by­
case
basis
for
other
types
of
disseminated
information
that
may
have
a
clear
and
substantial
impact
on
important
public
policies
or
private
sector
decisions.

6.3
How
Does
EPA
Ensure
and
Maximize
the
Quality
of
"
Influential"
Information?

EPA
recognizes
that
influential
scientific,
financial,
or
statistical
information
should
be
subject
to
a
higher
degree
of
quality
(
for
example,
transparency
about
data
and
methods)
than
information
that
may
not
have
a
clear
and
substantial
impact
on
important
public
policies
or
private
sector
decisions.
A
higher
degree
of
transparency
about
data
and
methods
will
facilitate
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
17"
Safety
risk
assessment"
describes
a
variety
of
analyses,
investigations,
or
case
studies
conducted
by
EPA
to
respond
to
environmental
emergencies.
For
example,
we
work
to
ensure
that
the
chemical
industry
and
state
and
local
entities
take
action
to
prevent,
plan
and
prepare
for,
and
respond
to
chemical
emergencies
through
the
development
and
sharing
of
information,
tools,
and
guidance
for
hazards
analyses
and
risk
assessment.

18Because
the
assessment
of
"
environmental
risk"
is
being
distinguished
from
"
human
health
risk,"
the
term
"
environmental
risk"
as
used
in
these
Guidelines
does
not
directly
involve
human
health
concerns.
In
other
words,
an
"
environmental
risk
assessment"
is
in
this
case
the
equivalent
to
what
EPA
commonly
calls
an
"
ecological
risk
Guidelines
for
Ensuring
and
Maximizing
Information
Quality
21
the
reproducibility
of
such
information
by
qualified
third
parties,
to
an
acceptable
degree
of
imprecision.
For
disseminated
influential
original
and
supporting
data,
EPA
intends
to
ensure
reproducibility
according
to
commonly
accepted
scientific,
financial,
or
statistical
standards.
It
is
important
that
analytic
results
for
influential
information
have
a
higher
degree
of
transparency
regarding
(
1)
the
source
of
the
data
used,
(
2)
the
various
assumptions
employed,
(
3)
the
analytic
methods
applied,
and
(
4)
the
statistical
procedures
employed.
It
is
also
important
that
the
degree
of
rigor
with
which
each
of
these
factors
is
presented
and
discussed
be
scaled
as
appropriate,
and
that
all
factors
be
presented
and
discussed.
In
addition,
if
access
to
data
and
methods
cannot
occur
due
to
compelling
interests
such
as
privacy,
trade
secrets,
intellectual
property,
and
other
confidentiality
protections,
EPA
should,
to
the
extent
practicable,
apply
especially
rigorous
robustness
checks
to
analytic
results
and
carefully
document
all
checks
that
were
undertaken.
Original
and
supporting
data
may
not
be
subject
to
the
high
and
specific
degree
of
transparency
provided
for
analytic
results;
however,
EPA
should
apply,
to
the
extent
practicable,
relevant
Agency
policies
and
procedures
to
achieve
reproducibility,
given
ethical,
feasibility,
and
confidentiality
constraints.

Several
Agency­
wide
and
Program­
and
Region­
specific
policies
and
processes
that
EPA
uses
to
ensure
and
maximize
the
quality
of
environmental
data,
including
disseminated
information
products,
would
also
apply
to
information
considered
"
influential"
under
these
Guidelines.
Agency­
wide
processes
of
particular
importance
to
ensure
the
quality,
objectivity,
and
transparency
of
"
influential"
information
include
the
Agency's
Quality
System,
Action
Development
Process,
Peer
Review
Policy,
and
related
procedures.
Many
"
influential"
information
products
may
be
subject
to
more
than
one
of
these
processes.

6.4
How
Does
EPA
Ensure
and
Maximize
the
Quality
of
"
Influential"
Scientific
Risk
Assessment
Information?

EPA
conducts
and
disseminates
a
variety
of
risk
assessments.
When
evaluating
environmental
problems
or
establishing
standards,
EPA
must
comply
with
statutory
requirements
and
mandates
set
by
Congress
based
on
media
(
air,
water,
solid,
and
hazardous
waste)
or
other
environmental
interests
(
pesticides
and
chemicals).
Consistent
with
EPA's
current
practices,
application
of
these
principles
involves
a
"
weight­
of­
evidence"
approach
that
considers
all
relevant
information
and
its
quality,
consistent
with
the
level
of
effort
and
complexity
of
detail
appropriate
to
a
particular
risk
assessment.
In
our
dissemination
of
influential
scientific
information
regarding
human
health,
safety17
or
environmental18
risk
assessments,
EPA
will
ensure,
to
the
extent
practicable
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
assessment".

19OMB
stated
in
its
guidelines
that
in
disseminating
information
agencies
shall
develop
a
process
for
reviewing
the
quality
of
the
information.
"
Quality"
includes
objectivity,
utility,
and
integrity.
"
Objectivity"
involves
two
distinct
elements,
presentation
and
substance.
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
Federal
Agencies,
OMB,
2002.
(
67
FR
8452)
http://
www.
whitehouse.
gov/
omb/
fedreg/
reproducible2.
pdf
20Safe
Drinking
Water
Act
Amendments
of
1996,
42
U.
S.
C.
300g­
1(
b)(
3)(
A)
&
(
B)

21The
exception
is
risk
assessments
conducted
under
SDWA
which
will
adhere
to
the
SDWA
principles
as
amended
in
1996.

22Agency
assessments
of
human
health
risks
necessarily
focus
on
populations.
Agency
assessments
of
ecological
risks
address
a
variety
of
entities,
some
of
which
can
be
described
as
populations
and
others
(
such
as
ecosystems)
which
cannot.
The
phrase
"
assessment
endpoint"
is
intended
to
reflect
the
broader
range
of
interests
inherent
in
ecological
risk
assessments.
As
discussed
in
the
EPA
Guidelines
for
Ecological
Risk
Assessment
(
found
at
http://
cfpub.
epa.
gov/
ncea/
cfm/
recordisplay.
cfm?
deid=
12460),
assessment
endpoints
are
explicit
expressions
of
the
actual
environmental
value
that
is
to
be
protected,
operationally
defined
by
an
ecological
entity
and
its
attributes.
Furthermore,
those
Guidelines
explain
that
an
ecological
entity
can
be
a
species
(
e.
g.,
eelgrass,
piping
plover),
a
community
(
e.
g.,
benthic
invertebrates),
an
ecosystem
(
e.
g.,
wetland),
or
other
entity
of
concern.
An
attribute
of
an
assessment
endpoint
is
the
characteristic
about
the
entity
of
concern
that
is
important
to
protect
and
potentially
at
risk.
Examples
of
attributes
include
abundance
(
of
a
population),
species
richness
(
of
a
community),
or
function
(
of
an
ecosystem).
Assessment
endpoints
and
ecological
risk
assessments
are
discussed
more
fully
in
those
Guidelines
as
well
as
other
EPA
sources
such
as
Ecological
Risk
Assessment
Guidance
for
Superfund:
Process
for
Designing
and
Conducting
Ecological
Risk
Assessments
­
Interim
Final
found
at
http://
www.
epa.
gov/
oerrpage/
superfund/
programs/
risk/
ecorisk/
ecorisk.
htm
Guidelines
for
Ensuring
and
Maximizing
Information
Quality
22
and
consistent
with
Agency
statutes
and
existing
legislative
regulations,
the
objectivity19
of
such
information
disseminated
by
the
Agency
by
applying
the
following
adaptation
of
the
quality
principles
found
in
the
Safe
Drinking
Water
Act20
(
SDWA)
Amendments
of
199621:

(
A)
The
substance
of
the
information
is
accurate,
reliable
and
unbiased.
This
involves
the
use
of:
(
i)
the
best
available
science
and
supporting
studies
conducted
in
accordance
with
sound
and
objective
scientific
practices,
including,
when
available,
peer
reviewed
science
and
supporting
studies;
and
(
ii)
data
collected
by
accepted
methods
or
best
available
methods
(
if
the
reliability
of
the
method
and
the
nature
of
the
decision
justifies
the
use
of
the
data).

(
B)
The
presentation
of
information
on
human
health,
safety,
or
environmental
risks,
consistent
with
the
purpose
of
the
information,
is
comprehensive,
informative,
and
understandable.
In
a
document
made
available
to
the
public,
EPA
specifies:

(
i)
each
population
addressed
by
any
estimate
of
applicable
human
health
risk
or
each
risk
assessment
endpoint,
including
populations
if
applicable,
addressed
by
any
estimate
of
applicable
ecological
risk22;
(
ii)
the
expected
risk
or
central
estimate
of
human
health
risk
for
the
specific
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
23Ibid.

Guidelines
for
Ensuring
and
Maximizing
Information
Quality
23
populations
affected
or
the
ecological
assessment
endpoints23,
including
populations
if
applicable;
(
iii)
each
appropriate
upper­
bound
or
lower­
bound
estimate
of
risk;
(
iv)
each
significant
uncertainty
identified
in
the
process
of
the
assessment
of
risk
and
studies
that
would
assist
in
resolving
the
uncertainty;
and
(
v)
peer­
reviewed
studies
known
to
the
Administrator
that
support,
are
directly
relevant
to,
or
fail
to
support
any
estimate
of
risk
and
the
methodology
used
to
reconcile
inconsistencies
in
the
scientific
data.

In
applying
these
principles,
"
best
available"
usually
refers
to
the
availability
at
the
time
an
assessment
is
made.
However,
EPA
also
recognizes
that
scientific
knowledge
about
risk
is
rapidly
changing
and
that
risk
information
may
need
to
be
updated
over
time.
When
deciding
which
influential
risk
assessment
should
be
updated
and
when
to
update
it,
the
Agency
will
take
into
account
its
statutes
and
the
extent
to
which
the
updated
risk
assessment
will
have
a
clear
and
substantial
impact
on
important
public
policies
or
private
sector
decisions.
In
some
situations,
the
Agency
may
need
to
weigh
the
resources
needed
and
the
potential
delay
associated
with
incorporating
additional
information
in
comparison
to
the
value
of
the
new
information
in
terms
of
its
potential
to
improve
the
substance
and
presentation
of
the
assessment.

Adaptation
clarifications
In
order
to
provide
more
clarity
on
how
EPA
adapted
the
SDWA
principles
in
this
guidance
in
light
of
our
numerous
statutes,
regulations,
guidance
and
policies
that
address
how
to
conduct
a
risk
assessment
and
characterize
risk
we
discuss
four
adaptations
EPA
has
made
to
the
SDWA
quality
principles
language.

EPA
adapted
the
SDWA
principles
by
adding
the
phrase
"
consistent
with
Agency
statutes
and
existing
legislative
regulations,
the
objectivity
of
such
information
disseminated
by
the
Agency"
in
the
introductory
paragraph,
therefore
applying
to
both
paragraphs
(
A)
and
(
B).
This
was
done
to
explain
EPA's
intent
regarding
these
quality
principles
and
their
implementation
consistent
with
our
statutes
and
existing
legislative
regulations.
Also,
as
noted
earlier,
EPA
intends
to
implement
these
quality
principles
in
conjunction
with
our
guidelines
and
policies.
The
procedures
set
forth
in
other
EPA
guidelines
set
out
in
more
detail
EPA's
policies
for
conducting
risk
assessments,
including
Agency­
wide
guidance
on
various
types
of
risk
assessments
and
program­
specific
guidance.
EPA
recognizes
that
the
wide
array
of
programs
within
EPA
have
resulted
not
only
in
Agency­
wide
guidance,
but
in
specific
protocols
that
reflect
the
requirements,
including
limitations,
that
are
mandated
by
the
various
statutes
administered
by
the
Agency.
For
example,
the
Agency
developed
several
pesticide
science
policy
papers
that
explained
to
the
public
in
detail
how
EPA
would
implement
specific
statutory
requirements
in
the
Food
Quality
Protection
Act
(
FQPA)
that
addressed
how
we
perform
risk
assessments.
We
also
recognize
that
emerging
issues
such
endocrine
disruption,
bioengineered
organisms,
and
genomics
may
involve
some
modifications
to
the
existing
paradigm
for
assessing
human
health
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
24The
discussion
in
this
and
following
paragraphs
gives
some
examples
of
the
types
of
assessments
that
may
under
some
circumstances
be
considered
influential.
These
examples
are
representative
of
assessments
performed
under
other
EPA
programs,
such
as
CERCLA
257
U.
S.
C.
136
et
seq.

2615
U.
S.
C.
2601
et
seq.

Guidelines
for
Ensuring
and
Maximizing
Information
Quality
24
and
ecological
risks.
This
does
not
mean
a
radical
departure
from
existing
guidance
or
the
SDWA
principles,
but
rather
indicates
that
flexibility
may
be
warranted
as
new
information
and
approaches
develop.

EPA
introduced
the
following
two
adaptations
in
order
to
accommodate
the
range
of
real­
world
situations
that
we
confront
in
the
implementation
of
our
diverse
programs.
EPA
adapted
the
SDWA
quality
principles
by
moving
the
phrase
"
to
the
extent
practicable"
from
paragraph
(
B)
to
the
introductory
paragraph
in
this
Guidelines
section
to
cover
both
parts
(
A)
and
(
B)
of
the
SDWA
adaptation.
24
The
phrase
refers
to
situations
under
(
A)
where
EPA
may
be
called
upon
to
conduct
"
influential"
scientific
risk
assessments
based
on
limited
information
or
in
novel
situations,
and
under
(
B)
in
recognition
that
all
such
"
presentation"
information
may
not
be
available
in
every
instance.
The
level
of
effort
and
complexity
of
a
risk
assessment
should
also
balance
the
information
needs
for
decision
making
with
the
effort
needed
to
develop
such
information.
For
example,
under
the
Federal
Insecticide,
Fungicide
and
Rodenticide
Act25
(
FIFRA)
and
the
Toxic
Substances
and
Control
Act26
(
TSCA),
regulated
entities
are
obligated
to
provide
information
to
EPA
concerning
incidents/
test
data
that
may
reveal
a
problem
with
a
pesticide
or
chemical.
We
also
receive
such
information
voluntarily
from
other
sources.
EPA
carefully
reviews
incident
reports
and
factors
them
as
appropriate
into
risk
assessments
and
decision­
making,
even
though
these
may
not
be
considered
information
collected
by
acceptable
methods
or
best
available
method
as
stated
in
A(
ii).
Incident
information
played
an
important
role
in
the
Agency's
conclusion
that
use
of
chlordane/
heptachlor
termiticides
could
result
in
exposures
to
persons
living
in
treated
homes,
and
that
the
registrations
needed
to
be
modified
accordingly.
Similarly,
incident
reports
concerning
birdkills
and
fishkills
were
important
components
of
the
risk
assessments
for
the
reregistration
of
the
pesticides
phorate
and
terbufos,
respectively.
In
addition,
this
adaptation
recognizes
that
while
many
of
the
studies
incorporated
into
risk
assessments
have
been
peer
reviewed,
data
from
other
sources
may
not
be
peer
reviewed.
EPA
takes
many
actions
based
on
studies
and
supporting
data
provided
by
outside
sources,
including
confidential
or
proprietary
information
that
has
not
been
peer
reviewed.
For
example,
industry
can
be
required
by
regulation
to
submit
data
for
pesticides
under
FIFRA
or
for
chemicals
under
TSCA.
The
data
are
developed
using
test
guidelines
and
Good
Laboratory
Practices
(
GLPs)
in
accordance
with
EPA
regulations.
While
there
is
not
a
requirement
to
have
studies
peer
reviewed,
such
studies
are
reviewed
by
Agency
scientists
to
ensure
that
they
were
conducted
according
to
the
appropriate
test
guidelines
and
GLPs
and
that
the
data
are
valid.

The
flexibility
provided
by
applying
"
to
the
extent
practicable"
to
paragraph
(
A)
is
appropriate
in
many
circumstances
to
conserve
Agency
resources
and
those
of
the
regulated
community
who
otherwise
might
have
to
generate
significant
additional
data.
This
flexibility
is
already
provided
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
27
Section
18
of
FIFRA,
7
U.
S.
C.
136p
28
Section
5
of
TSCA,
15
U.
S.
C.
2604
Guidelines
for
Ensuring
and
Maximizing
Information
Quality
25
for
paragraph
(
B)
in
the
SDWA
quality
principles.
Pesticide
and
chemical
risk
assessments
are
frequently
performed
iteratively,
with
the
first
iteration
employing
protective
(
conservative)
assumptions
to
identify
possible
risks.
Only
if
potential
risks
are
identified
in
a
screening
level
assessment,
is
it
necessary
to
pursue
a
more
refined,
data­
intensive
risk
assessment.
This
is
exhibited,
for
example,
in
guidance
developed
for
use
in
CERCLA
and
RCRA
on
tiered
approaches.
In
other
cases,
reliance
on
"
structure
activity
relationship"
or
"
bridging
data"
allows
the
Agency
to
rely
on
data
from
similar
chemicals
rather
than
require
the
generation
of
new,
chemical­
specific
data.
While
such
assessments
may
or
may
not
be
considered
influential
under
the
Guidelines,
this
adaptation
of
the
SDWA
principles
reflects
EPA's
reliance
on
less­
refined
risk
assessments
where
further
refinement
could
significantly
increase
the
cost
of
the
risk
assessment
without
significantly
enhancing
the
assessment
or
changing
the
regulatory
outcome.

In
emergency
and
other
time
critical
circumstances,
risk
assessments
may
have
to
rely
on
information
at
hand
or
that
can
be
made
readily
available
rather
than
data
such
as
described
in
(
A).
One
such
scenario
is
risk
assessments
addressing
Emergency
Exemption
requests
submitted
under
Section
18
of
FIFRA27
which,
because
of
the
emergency
nature
of
the
request,
must
be
completed
within
a
short
time
frame.
As
an
example,
EPA
granted
an
emergency
exemption
under
Section
18
to
allow
use
of
an
unregistered
pesticide
to
decontaminate
anthrax
in
a
Senate
office
building.
The
scientific
review
and
risk
assessment
to
support
this
action
were
necessarily
constrained
by
the
urgency
of
the
action.
Other
time­
sensitive
actions
include
the
reviews
of
new
chemicals
under
TSCA.
Under
Section
5
of
TSCA28,
EPA
must
review
a
large
number
of
pre­
manufacture
notifications
(
more
than
1,000)
every
year,
not
all
of
which
necessarily
include
"
influential"
risk
assessments,
and
each
review
must
be
completed
within
a
short
time
frame
(
generally
90
days).
The
nature
of
the
reviews
and
risk
assessment
associated
with
these
pre­
manufacture
notifications
are
affected
by
the
limited
time
available
and
the
large
volume
of
notifications
submitted.

The
flexibility
provided
by
applying
"
to
the
extent
practicable"
to
paragraph
(
A)
is
appropriate
to
account
for
safety
risk
assessment
practices.
This
flexibility
is
already
provided
for
paragraph
(
B)
in
the
SDWA
quality
principles.
We
applied
the
same
SDWA
adaptation
for
use
with
human
health
risk
assessments
to
safety
risk
assessments
with
the
needed
flexibility
to
apply
the
principles
to
the
extent
practicable.
"
Safety
risk
assessments"
include
a
variety
of
analyses,
investigations,
or
case
studies
conducted
by
EPA
concerning
safety
issues.
EPA
works
to
ensure
that
the
chemical
industry
and
state
and
local
entities
take
action
to
prevent,
plan
and
prepare
for,
and
respond
to
environmental
emergencies
and
site
specific
response
actions
through
the
development
and
sharing
of
information,
tools
and
guidance
for
hazard
analyses
and
risk
assessment.
For
example,
although
the
chemical
industry
shoulders
most
of
the
responsibility
for
safety
risk
assessment
and
management,
EPA
may
also
conduct
chemical
hazard
analyses,
investigate
the
root
causes
and
mechanisms
associated
with
accidental
chemical
releases,
and
assess
the
probability
and
consequences
of
accidental
releases
in
support
of
agency
risk
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
29
The
weight­
of­
evidence
approach
generally
considers
all
relevant
information
in
an
integrative
assessment
that
takes
into
account
the
kinds
of
evidence
available,
the
quality
and
quantity
of
the
evidence,
the
strengths
and
limitations
associated
of
each
type
of
evidence,
and
explains
how
the
various
types
of
evidence
fit
together.
See,
e.
g.,
EPA's
Proposed
Guidelines
for
Carcinogen
Risk
Assessment
(
Federal
Register
61(
79):
17960­
18011;
April
23,
1996)
and
EPA's
Guidelines
for
Carcinogen
Risk
Assessment
(
Federal
Register
51(
185):
33992­
34003;
September
24,
1986),
available
from:
www.
epa.
gov/
ncea/
raf/,
and
EPA's
Risk
Characterization
Handbook
(
Science
Policy
Council
Handbook:
Risk
Characterization,
EPA
100­
B­
00­
002,
Washington,
DC:
U.
S.
EPA,
December
2000).

3040
CFR
part
158
Guidelines
for
Ensuring
and
Maximizing
Information
Quality
26
assessments.
Although
safety
risk
assessments
can
be
different
from
traditional
human
health
risk
assessments
because
they
may
combine
a
variety
of
available
information
and
may
use
expert
judgement
based
on
that
information,
these
assessments
provide
useful
information
that
is
sufficient
for
the
intended
purpose.

Next,
EPA
adapted
the
SDWA
quality
principles
by
adding
the
clause
"
including,
when
available,
peer
reviewed
science
and
supporting
studies"
to
paragraph
(
A)(
i).
It
now
reads:
"
the
best
available
science
and
supporting
studies
conducted
in
accordance
with
sound
and
objective
scientific
practices,
including,
when
available,
peer
reviewed
science
and
supporting
studies."
In
the
Agency's
development
of
"
influential"
scientific
risk
assessments,
we
intend
to
use
all
relevant
information,
including
peer
reviewed
studies,
studies
that
have
not
been
peer
reviewed,
and
incident
information;
evaluate
that
information
based
on
sound
scientific
practices
as
described
in
our
risk
assessment
guidelines
and
policies;
and
reach
a
position
based
on
careful
consideration
of
all
such
information
(
i.
e.,
a
process
typically
referred
to
as
the
"
weight­
ofevidence
approach29).
In
this
approach,
a
well­
developed,
peer­
reviewed
study
would
generally
be
accorded
greater
weight
than
information
from
a
less
well­
developed
study
that
had
not
been
peer­
reviewed,
but
both
studies
would
be
considered.
Thus
the
Agency
uses
a
"
weight­
ofevidence
process
when
evaluating
peer­
reviewed
studies
along
with
all
other
information.

Oftentimes
under
various
EPA­
managed
programs,
EPA
receives
information
that
has
not
been
peer­
reviewed
and
we
have
to
make
decisions
based
on
the
information
available.
While
many
of
the
studies
incorporated
in
risk
assessments
have
been
peer
reviewed,
data
from
other
sources,
such
as
studies
submitted
to
the
Agency
for
pesticides
under
FIFRA30
and
for
chemicals
under
TSCA,
may
not
always
be
peer
reviewed.
Rather,
such
data,
developed
under
approved
guidelines
and
the
application
of
Good
Laboratory
Practices
(
GLPs),
are
routinely
used
in
the
development
of
risk
assessments.
Risk
assessments
may
also
include
more
limited
data
sets
such
as
monitoring
data
used
to
support
the
exposure
element
of
a
risk
assessment.
In
cases
where
these
data
may
not
themselves
have
been
peer
reviewed
their
quality
and
appropriate
use
would
be
addressed
as
part
of
the
peer
review
of
the
overall
risk
assessment
as
called
for
under
the
Agency's
peer
review
guidelines.

Lastly,
EPA
adapted
the
SDWA
principles
for
influential
environmental
("
ecological")
risk
assessments
that
are
disseminated
in
order
to
use
terms
that
are
most
suited
for
such
risk
assessments.
Specifically,
EPA
assessments
of
ecological
risks
address
a
variety
of
entities,
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Guidelines
for
Ensuring
and
Maximizing
Information
Quality
27
some
of
which
can
be
described
as
populations
and
others
(
such
as
ecosystems)
which
cannot.
Therefore,
a
specific
modification
was
made
to
include
"
assessment
endpoints,
including
populations
if
applicable"
in
place
of
the
term
"
population"
for
ecological
risk
assessments
and
EPA
added
a
footnote
directing
the
reader
to
various
EPA
risk
policies
for
further
discussion
of
these
concepts
in
greater
detail.
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
31
EPA
Quality
Manual
for
Environmental
Programs
5360
A1.
May
2000,
Section
1.3.1.
http://
www.
epa.
gov/
quality/
qs­
docs/
5360.
pdf
32
44
U.
S.
C.
3501
et
seq.

Guidelines
for
Ensuring
and
Maximizing
Information
Quality
28
6.5
Does
EPA
Ensure
and
Maximize
the
Quality
of
Information
from
External
Sources?

Ensuring
and
maximizing
the
quality
of
information
from
States,
other
governments,
and
third
parties
is
a
complex
undertaking,
involving
thoughtful
collaboration
with
States,
Tribes,
the
scientific
and
technical
community,
and
other
external
information
providers.
EPA
will
continue
to
take
steps
to
ensure
that
the
quality
and
transparency
of
information
provided
by
external
sources
are
sufficient
for
the
intended
use.
For
instance,
since
1998,
the
use
of
environmental
data
collected
by
others
or
for
other
purposes,
including
literature,
industry
surveys,
compilations
from
computerized
data
bases
and
information
systems,
and
results
from
computerized
or
mathematical
models
of
environmental
processes
and
conditions
has
been
within
the
scope
of
the
Agency's
Quality
System31.

For
information
that
is
either
voluntarily
submitted
to
EPA
in
hopes
of
influencing
a
decision
or
that
EPA
obtains
for
use
in
developing
a
policy,
regulatory,
or
other
decision,
EPA
will
continue
to
work
with
States
and
other
governments,
the
scientific
and
technical
community,
and
other
interested
information
providers
to
develop
and
publish
factors
that
EPA
would
use
to
assess
the
quality
of
this
type
of
information.

For
all
proposed
collections
of
information
that
will
be
disseminated
to
the
public,
EPA
intends
to
demonstrate
in
our
Paperwork
Reduction
Act32
clearance
submissions
that
the
proposed
collection
of
information
will
result
in
information
that
will
be
collected,
maintained
and
used
in
ways
consistent
with
the
OMB
guidelines
and
these
EPA
Guidelines.
These
Guidelines
apply
to
all
information
EPA
disseminates
to
the
public;
accordingly,
if
EPA
later
identifies
a
new
use
for
the
information
that
was
collected,
such
use
would
not
be
precluded
and
the
Guidelines
would
apply
to
the
dissemination
of
the
information
to
the
public.
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Administrative
Mechanism
for
Pre­
dissemination
Review
29
7
Administrative
Mechanism
for
Pre­
dissemination
Review
7.1
What
are
the
Administrative
Mechanisms
for
Pre­
dissemination
Reviews?

Each
EPA
Program
Office
and
Region
will
incorporate
the
information
quality
principles
outlined
in
section
6
of
these
Guidelines
into
their
existing
pre­
dissemination
review
procedures
as
appropriate.
Offices
and
Regions
may
develop
unique
and
new
procedures,
as
needed,
to
provide
additional
assurance
that
the
information
disseminated
by
or
on
behalf
of
their
organizations
is
consistent
with
these
Guidelines.
EPA
intends
to
facilitate
implementation
of
consistent
cross­
Agency
pre­
dissemination
reviews
by
establishing
a
model
of
minimum
review
standards
based
on
existing
policies.
Such
a
model
for
pre­
dissemination
review
would
still
provide
that
responsibility
for
the
reviews
remains
in
the
appropriate
EPA
Office
or
Region.

For
the
purposes
of
the
Guidelines,
EPA
recognizes
that
pre­
dissemination
review
procedures
may
include
peer
reviews
and
quality
reviews
that
may
occur
at
many
steps
in
development
of
information,
not
only
at
the
point
immediately
prior
to
the
dissemination
of
the
information.
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Administrative
Mechanisms
for
Correction
of
Information
30
8
Administrative
Mechanisms
for
Correction
of
Information
8.1
What
are
EPA's
Administrative
Mechanisms
for
Affected
Persons
to
Seek
and
Obtain
Correction
of
Information?

EPA's
Office
of
Environmental
Information
(
OEI)
manages
the
administrative
mechanisms
that
enable
affected
persons
to
seek
and
obtain,
where
appropriate,
correction
of
information
disseminated
by
the
Agency
that
does
not
comply
with
EPA
or
OMB
Information
Quality
Guidelines.
Working
with
the
Program
Offices,
Regions,
laboratories,
and
field
offices,
OEI
will
receive
complaints
(
or
copies)
and
distribute
them
to
the
appropriate
EPA
information
owners.
"
Information
owners"
are
the
responsible
persons
designated
by
management
in
the
applicable
EPA
Program
Office,
or
those
who
have
responsibility
for
the
quality,
objectivity,
utility,
and
integrity
of
the
information
product
or
data
disseminated
by
EPA.
If
a
person
believes
that
information
disseminated
by
EPA
may
not
comply
with
the
Guidelines,
we
encourage
the
person
to
consult
informally
with
the
contact
person
listed
in
the
information
product
before
submitting
a
request
for
correction
of
information.
An
informal
contact
can
result
in
a
quick
and
efficient
resolution
of
questions
about
information
quality.

8.2
What
Should
be
Included
in
a
Request
for
Correction
of
Information?

Persons
requesting
a
correction
of
information
should
include
the
following
information
in
their
Request
for
Correction
(
RFC):

°
Name
and
contact
information
for
the
individual
or
organization
submitting
a
complaint;
identification
of
an
individual
to
serve
as
a
contact.

°
A
description
of
the
information
the
person
believes
does
not
comply
with
EPA
or
OMB
guidelines,
including
specific
citations
to
the
information
and
to
the
EPA
or
OMB
guidelines,
if
applicable.

°
An
explanation
of
how
the
information
does
not
comply
with
EPA
or
OMB
guidelines
and
a
recommendation
of
corrective
action.
EPA
considers
that
the
complainant
has
the
burden
of
demonstrating
that
the
information
does
not
comply
with
EPA
or
OMB
guidelines
and
that
a
particular
corrective
action
would
be
appropriate.

°
An
explanation
of
how
the
alleged
error
affects
or
how
a
correction
would
benefit
the
requestor.

°
An
affected
person
may
submit
an
RFC
via
any
one
of
methods
listed
here:
°
Internet
at
http://
www.
epa.
gov/
oei/
qualityguidelines
°
E­
mail
at
quality.
guidelines@
epa.
gov
°
Fax
at
(
202)
566­
0255
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Administrative
Mechanisms
for
Correction
of
Information
31
°
Mail
to
Information
Quality
Guidelines
Staff,
Mail
Code
28221T,
U.
S.
EPA,
1200
Pennsylvania
Ave.,
N.
W.,
Washington,
DC,
20460
°
By
courier
or
in
person
to
Information
Quality
Guidelines
Staff,
OEI
Docket
Center,
Room
B128,
EPA
West
Building,
1301
Constitution
Ave.,
N.
W.,
Washington,
DC
8.3
When
Does
EPA
Intend
to
Consider
a
Request
for
Correction
of
Information?

EPA
seeks
public
and
stakeholder
input
on
a
wide
variety
of
issues,
including
the
identification
and
resolution
of
discrepancies
in
EPA
data
and
information.
EPA
may
decline
to
review
an
RFC
under
these
Guidelines
and
consider
it
for
correction
if:

°
The
request
does
not
address
information
disseminated
to
the
public
covered
by
these
Guidelines
(
see
section
5.3
or
OMB's
guidelines).
In
many
cases,
EPA
provides
other
correction
processes
for
information
not
covered
by
these
Guidelines.

°
The
request
omits
one
or
more
of
the
elements
recommended
in
section
8.2
and
there
is
insufficient
information
for
EPA
to
provide
a
satisfactory
response.

°
The
request
itself
is
"
frivolous,"
including
those
made
in
bad
faith,
made
without
justification
or
trivial,
and
for
which
a
response
would
be
duplicative.
More
information
on
this
subject
may
be
found
in
the
OMB
guidelines.

8.4
How
Does
EPA
Intend
to
Respond
to
a
Request
for
Correction
of
Information?

EPA
intends
to
use
the
following
process:

°
Each
RFC
will
be
tracked
in
an
OEI
system.

°
If
an
RFC
is
deemed
appropriate
for
consideration,
the
information
owner
office
or
region
makes
a
decision
on
the
request
on
the
basis
of
the
information
in
question,
including
a
request
submitted
under
section
8.2.
Rejections
of
a
request
for
correction
should
be
decided
at
the
highest
level
of
the
information
owner
office
or
region.
EPA's
goal
is
to
respond
to
requests
within
90
days
of
receipt,
by
1)
providing
either
a
decision
on
the
request,
or
2)
if
the
request
requires
more
than
90
calendar
days
to
resolve,
informing
the
complainant
that
more
time
is
required
and
indicate
the
reason
why
and
an
estimated
decision
date.

°
If
a
request
is
approved,
EPA
determines
what
corrective
action
is
appropriate.
Considerations
relevant
to
the
determination
of
appropriate
corrective
action
include
the
nature
and
timeliness
of
the
information
involved
and
such
factors
as
the
significance
of
the
error
on
the
use
of
the
information
and
the
magnitude
of
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Administrative
Mechanisms
for
Correction
of
Information
32
the
error.
For
requests
involving
information
from
outside
sources,
considerations
may
include
coordinating
with
the
source
and
other
practical
limitations
on
EPA's
ability
to
take
corrective
action.

°
Whether
or
not
EPA
determines
that
corrective
action
is
appropriate,
EPA
provides
notice
of
its
decision
to
the
requester.

°
For
approved
requests,
EPA
assigns
a
steward
for
the
correction
who
marks
the
information
as
designated
for
corrections
as
appropriate,
establishes
a
schedule
for
correction,
and
reports
correction
resolution
to
both
the
tracking
system
and
to
the
requestor.

OEI
will
provide
reports
on
behalf
of
EPA
to
OMB
on
an
annual
basis
beginning
January
1,
2004
regarding
the
number,
nature,
and
resolution
of
complaints
received
by
EPA.

8.5
How
Does
EPA
Expect
to
Process
Requests
for
Correction
of
Information
on
Which
EPA
has
Sought
Public
Comment?

When
EPA
provides
opportunities
for
public
participation
by
seeking
comments
on
information,
the
public
comment
process
should
address
concerns
about
EPA's
information.
For
example,
when
EPA
issues
a
notice
of
proposed
rulemaking
supported
by
studies
and
other
information
described
in
the
proposal
or
included
in
the
rulemaking
docket,
it
disseminates
this
information
within
the
meaning
of
the
Guidelines.
The
public
may
then
raise
issues
in
comments
regarding
the
information.
If
a
group
or
an
individual
raises
a
question
regarding
information
supporting
a
proposed
rule,
EPA
generally
expects
to
treat
it
procedurally
like
a
comment
to
the
rulemaking,
addressing
it
in
the
response
to
comments
rather
than
through
a
separate
response
mechanism.
This
approach
would
also
generally
apply
to
other
processes
involving
a
structured
opportunity
for
public
comment
on
a
draft
or
proposed
document
before
a
final
document
is
issued,
such
as
a
draft
report,
risk
assessment,
or
guidance
document.
EPA
believes
that
the
thorough
consideration
provided
by
the
public
comment
process
serves
the
purposes
of
the
Guidelines,
provides
an
opportunity
for
correction
of
any
information
that
does
not
comply
with
the
Guidelines,
and
does
not
duplicate
or
interfere
with
the
orderly
conduct
of
the
action.
In
cases
where
the
Agency
disseminates
a
study,
analysis,
or
other
information
prior
to
the
final
Agency
action
or
information
product,
it
is
EPA
policy
to
consider
requests
for
correction
prior
to
the
final
Agency
action
or
information
product
in
those
cases
where
the
Agency
has
determined
that
an
earlier
response
would
not
unduly
delay
issuance
of
the
Agency
action
or
information
product
and
the
complainant
has
shown
a
reasonable
likelihood
of
suffering
actual
harm
from
the
Agency's
dissemination
if
the
Agency
does
not
resolve
the
complaint
prior
to
the
final
Agency
action
or
information
product.
EPA
does
not
expect
this
to
be
the
norm
in
rulemakings
that
it
conducts,
and
thus
will
usually
address
information
quality
issues
in
connection
with
the
final
Agency
action
or
information
product.
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Administrative
Mechanisms
for
Correction
of
Information
33
EPA
generally
would
not
consider
a
complaint
that
could
have
been
submitted
as
a
timely
comment
in
the
rulemaking
or
other
action
but
was
submitted
after
the
comment
period.
If
EPA
cannot
respond
to
a
complaint
in
the
response
to
comments
for
the
action
(
for
example,
because
the
complaint
is
submitted
too
late
to
be
considered
and
could
not
have
been
timely
submitted,
or
because
the
complaint
is
not
germane
to
the
action),
EPA
will
consider
whether
a
separate
response
to
the
complaint
is
appropriate.
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Administrative
Mechanisms
for
Correction
of
Information
34
8.6
What
Should
be
Included
in
a
Request
Asking
EPA
to
Reconsider
its
Decision
on
a
Request
for
the
Correction
of
Information?

If
requesters
are
dissatisfied
with
an
EPA
decision,
they
may
file
a
Request
for
Reconsideration
(
RFR).
The
RFR
should
contain
the
following
information:

°
An
indication
that
the
person
is
seeking
an
appeal
of
an
EPA
decision
on
a
previously
submitted
request
for
a
correction
of
information,
including
the
date
of
the
original
submission
and
date
of
EPA
decision.
A
copy
of
EPA's
original
decision
would
help
expedite
the
process.

°
Name
and
contact
information.
Organizations
submitting
an
RFR
should
identify
an
individual
as
a
contact.

°
An
explanation
of
why
the
person
disagrees
with
the
EPA
decision
and
a
specific
recommendation
for
corrective
action.

°
A
copy
of
the
original
RFC
of
information.

°
An
affected
person
may
submit
a
Request
for
Reconsideration
(
RFR)
via
any
one
of
the
methods
listed
here:
°
Internet
at
http://
www.
epa.
gov/
oei/
qualityguidelines
°
E­
mail
at
quality.
guidelines@
epa.
gov
°
Fax
at
(
202)
566­
0255
°
Mail
to
Information
Quality
Guidelines
Staff,
Mail
Code
28221T,
U.
S.
EPA,
1200
Pennsylvania
Ave.,
N.
W.,
Washington,
DC,
20460
°
By
courier
or
in
person
to
Information
Quality
Guidelines
Staff,
OEI
Docket
Center,
Room
B128,
EPA
West
Building,
1301
Constitution
Ave.,
N.
W.,
Washington,
DC
EPA
recommends
that
requesters
submit
their
RFR
within
90
days
of
the
EPA
decision.
If
the
RFR
is
sent
after
that
time,
EPA
recommends
that
the
requester
include
an
explanation
of
why
the
request
should
be
considered
at
this
time.

8.7
How
Does
EPA
Intend
to
Process
Requests
for
Reconsideration
of
EPA
Decisions?

EPA
intends
to
consider
RFR
using
the
following
process:

°
Each
RFR
will
be
tracked
in
an
OEI
system.

°
OEI
sends
the
RFR
to
the
appropriate
EPA
Program
Office
or
Region
that
has
responsibility
for
the
information
in
question.
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Administrative
Mechanisms
for
Correction
of
Information
35
°
The
Assistant
Administrator
(
AA)
or
Regional
Administrator
(
RA)
information
owner
presents
to
an
executive
panel.
The
executive
panel
would
be
comprised
of
the
Science
Advisor/
AA
for
the
Office
of
Research
and
Development
(
ORD),
Chief
Information
Officer/
AA
for
OEI,
and
the
Economics
Advisor/
AA
for
the
Office
of
Policy,
Economics
and
Innovation
(
OPEI.).
The
3­
member
executive
panel
would
be
chaired
by
the
Chief
Information
Officer/
AA
for
OEI.
When
the
subject
of
the
RFR
originated
from
a
member
office,
that
panel
member
would
be
replaced
by
an
alternate
AA
or
RA.
While
the
executive
panel
is
considering
an
RFR,
the
decision
made
on
the
initial
complaint
by
the
information
owner
office
or
region
remains
in
effect.

°
The
executive
panel
makes
the
final
decision
on
the
RFR.

°
EPA's
goal
is
to
respond
to
each
RFR
within
90
days
of
receipt,
by
1)
providing
either
a
decision
on
the
request
or
2)
if
the
request
requires
more
than
90
calendar
days
to
resolve,
informing
the
complainant
that
more
time
is
required
and
indicate
the
reason
why
and
an
estimated
decision
date.

°
If
a
request
is
approved,
EPA
determines
what
type
of
corrective
action
is
appropriate.
Considerations
relevant
to
the
determination
of
appropriate
corrective
action
include
the
nature
and
timeliness
of
the
information
involved
and
such
factors
as
the
significance
of
the
error
on
the
use
of
the
information
and
the
magnitude
of
the
error.
For
requests
involving
information
from
outside
sources,
considerations
may
include
coordinating
with
the
source,
and
other
practical
limitations
on
EPA's
ability
to
take
corrective
action.

°
Whether
or
not
EPA
determines
that
corrective
action
is
appropriate,
EPA
provides
notice
of
its
decision
to
the
requester.

°
For
approved
requests,
EPA
assigns
a
steward
for
the
correction
who
marks
the
information
as
designated
for
corrections
as
appropriate,
establishes
a
schedule
for
correction,
and
reports
correction
resolution
to
both
the
tracking
system
and
to
the
requestor.
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Appendix
36
Appendix
A
IQG
Development
Process
and
Discussion
of
Public
Comments
A.
1
Introduction
EPA's
Guidelines
are
a
living
document
and
may
be
revised
as
we
learn
more
about
how
best
to
address,
ensure,
and
maximize
information
quality.
In
the
process
of
developing
these
Guidelines,
we
actively
solicited
public
input
at
many
stages.
While
the
public
was
free
to
comment
on
any
aspect
of
the
Guidelines,
EPA
explicitly
requested
input
on
key
topics
such
as
influential
information,
reproducibility,
influential
risk
assessment,
information
sources,
and
error
correction.

Public
input
was
sought
in
the
following
ways:

°
An
online
Public
Comment
Session
was
held
March
19­
22,
2002,
as
the
first
draft
of
the
Guidelines
was
being
developed.
EPA
received
approximately
100
comments.

°
A
Public
Meeting
was
held
on
May
15,
2002,
after
the
draft
Guidelines
were
issued.
There
were
99
participants,
13
of
whom
made
presentations
or
commented
on
one
or
more
issues.

°
A
52
day
Public
Comment
period
lasted
from
May
1
to
June
21,
2002,
where
comments
could
be
mailed,
faxed,
or
e­
mailed
to
EPA.
EPA
received
55
comments
during
this
period.

°
A
meeting
with
State
representatives,
sponsored
and
supported
by
the
Environmental
Council
of
the
States
(
ECOS),
was
held
on
May
29,
2002.

°
A
conference
call
between
EPA
and
Tribal
representatives
was
held
on
June
27,
2002.

More
detailed
information
on
the
public
comments
is
available
through
an
OEI
web
site,
serving
as
the
home
page
for
the
EPA
Information
Quality
Guidelines
through
the
development
and
implementation
process.
Please
visit
this
site
at
http://
www.
epa.
gov/
oei/
qualityguidelines.

We
have
established
a
public
docket
for
the
EPA
Information
Quality
Guidelines
under
Docket
ID
No.
OEI­
10014.
The
docket
is
the
collection
of
materials
available
for
public
viewing
Information
Quality
Guidelines
Staff,
OEI
Docket
Center,
Room
B128,
EPA
West
Building,
1301
Constitution
Ave.,
N.
W.,
Washington,
DC,
phone
number
202­
566­
0284.
This
docket
consists
of
a
copy
of
the
Guidelines,
public
comments
received,
and
other
information
related
to
the
Guidelines.
The
docket
is
open
from
12:
00
PM
to
4:
00
PM,
Monday
through
Friday,
excluding
legal
holidays.
An
index
of
docket
contents
will
be
available
at
http://
www.
epa.
gov/
oei/
qualityguidelines.
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Appendix
37
A.
2
General
Summary
of
Comments
During
the
various
public
comment
opportunities,
EPA
received
input
from
a
diverse
set
of
organizations
and
private
citizens.
Comments
came
from
many
of
EPA's
stakeholders
­
the
regulated
community
and
many
interest
groups
who
we
hear
from
frequently
during
the
management
of
EPA's
Programs
to
protect
the
nation's
land,
air,
water,
and
public
health.
Government
agencies
at
the
Federal,
State,
Tribal,
and
local
level
also
commented
on
the
Guidelines.
OMB
sent
comments
to
every
Federal
agency
and
EPA
received
comments
from
two
members
of
Congress.
Beyond
our
government
colleagues,
the
private
sector
voiced
many
concerns
and
helpful
recommendations
for
these
Guidelines.
We
would
like
to
take
this
opportunity
to
thank
all
commenters
for
providing
their
input
on
these
Guidelines.
Due
to
the
tight
time
frame
for
this
project,
this
discussion
of
public
comments
generally
describes
the
major
categories
of
comments
and
highlights
some
significant
comments,
but
does
not
contain
an
individual
response
to
each
public
comment.

Comments
received
by
EPA
during
the
public
comment
period
reflect
a
diversity
of
views
regarding
EPA's
approach
to
developing
draft
Guidelines
as
well
as
the
general
concept
of
information
quality.
Some
commenters
included
detailed
review
of
all
Guidelines
sections,
while
others
chose
to
address
only
specific
topics.
In
some
cases,
commenters
provided
examples
to
demonstrate
how
current
EPA
procedures
may
not
ensure
adequate
information
quality
for
a
specific
application.
Commenters
provided
general
observations
such
as
stating
that
these
Guidelines
did
not
sufficiently
address
EPA's
information
quality
problems.
Some
commenters
offered
that
the
Guidelines
relied
too
much
on
existing
policies.
Interpretations
of
the
intent
of
the
Data
Quality
Act
were
offered
by
some
commenters.
One
comment
noted
that
improvement
of
data
quality
is
not
necessarily
an
end
in
and
of
itself.
Another
comment
was
that
the
goal
of
Guidelines
should
be
more
to
improve
quality,
not
end
uncertainty.
Public
interest
and
environmental
groups
voiced
concern
over
what
they
believed
was
an
attempt
by
various
groups
to
undermine
EPA's
ability
to
act
in
a
timely
fashion
to
protect
the
environment
and
public
health.
Some
commenters
stated
that
the
directives
of
the
Data
Quality
Act
and
OMB
cannot
override
EPA's
mission
to
protect
human
health
and
the
environment
per
the
statutory
mandates
under
which
it
operates.

EPA
was
congratulated
for
the
effort
and,
in
some
cases,
encouraged
to
go
even
further
in
addressing
information
quality.
Some
commenters
encouraged
EPA
to
provide
additional
process
details,
provide
more
detailed
definitions,
augment
existing
policies
that
promote
transparency,
and
share
more
information
about
the
limitations
of
EPA
disseminated
information.
In
one
case,
EPA
was
encouraged
to
develop
a
rating
scheme
for
its
disseminated
information.

This
section
discusses
public
comments
and
our
responses
to
many
of
the
important
questions
and
issues
raised
in
the
comments.
First,
we
provide
responses
to
some
overarching
comments
we
received
from
many
commenters,
then
we
provide
a
discussion
of
public
comments
that
were
received
on
specific
topics
addressed
in
the
draft
Guidelines.
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Appendix
38
°
Tone:
Commenters
criticized
the
"
defensive
tone",
"
legalistic
tone",
and
the
lack
of
detail
afforded
in
the
Guidelines.
Some
commenters
said
that
it
was
not
clear
what
the
Guidelines
were
explaining,
or
how
they
might
apply
to
various
types
of
information.
We
understand
and
agree
with
many
of
these
criticisms
and
have
made
attempts
to
better
communicate
the
purpose,
applicability,
and
content
of
these
Guidelines.

°
Plan
for
implementation:
Commenters
suggested
that
the
Guidelines
should
describe
EPA's
plans
for
implementing
the
Guidelines.
These
Guidelines
provide
policy
guidance,
and
as
such,
do
not
outline
EPA's
plan
for
implementation.
That
is,
they
do
not
describe
in
great
detail
how
each
Program
and
Regional
Office
will
implement
these
principles.
We
do
not
intend
to
imply
that
each
Office
will
implement
them
in
conflict
with
one
another,
but
rather
assume
that
because
each
Program
implements
a
different
statutory
mandate
or
mandates,
there
will
be
some
inherent
differences
in
approach.
Beyond
internal
implementation,
we
agree
that
there
is
more
work
and
communication
to
be
conducted
with
information
providers
and
users
to
optimize
the
provisions
set
forth
in
these
Guidelines.

°
Commitment
to
public
access:
One
commenter
suggested
that
we
"
remove
outdated
information"
from
our
web
site.
Other
commenters
suggested
that
when
a
complaint
has
been
filed
that
the
information
should
be
removed
from
public
view
while
a
complaint
is
being
reviewed.
This
is
generally
unacceptable
to
EPA
in
light
of
our
commitment
to
providing
the
public
with
access
to
information;
however,
in
certain
cases
EPA
may
consider
immediate
removal
of
information
(
for
example,
when
it
is
clear
to
us
that
the
information
is
grossly
incorrect
and
misleading
and
its
status
cannot
be
adequately
clarified
through
a
notice
or
other
explanation).
With
respect
to
outdated
information,
sometimes
it
serves
a
historical
purpose,
and
should
continue
to
be
disseminated
for
that
purpose.

A.
3
Response
to
Comments
by
Guidelines
Topic
Area
A.
3.1
Existing
Policy
Many
commenters
told
us
that
we
rely
excessively
on
existing
EPA
information
quality
policies.
Commenters
provided
specific
examples
of
areas
they
believed
were
demonstrative
of
our
lack
of
commitment
to
or
uneven
implementation
of
our
existing
policies.
Some
commenters
also
pointed
out
that
there
are
key
areas
in
which
we
lack
policies
to
address
quality
and,
as
a
result,
the
Guidelines
should
address
such
issues
in
more
detail.
Some
commenters
also
noted
that
EPA
itself
has
highlighted
lessons
learned
with
existing
approaches
to
information
product
development.

Ongoing
improvement
in
implementing
existing
processes
is
a
key
principle
of
quality
management.
We
view
these
Guidelines
as
an
opportunity
to
enhance
existing
policies
and
redouble
our
commitment
to
quality
information.
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
33http://
epa.
gov/
osp/
spc/
perevmem.
htm
Appendix
39
The
concept
of
peer
review
is
considered
in
three
Guidelines
sections.
(
1)
Application
of
the
Agency's
Peer
Review
Policy
language
for
"
major
scientific
and
technical
work
products
and
economic
analysis
used
in
decision
making"
as
a
class
of
information
that
can
be
considered
"
influential"
for
purposes
of
the
Guidelines;
(
2)
Use
of
"
peer­
reviewed
science"
as
a
component
of
some
risk
assessments;
and
(
3)
Use
of
the
Agency's
Peer
Review
Policy
as
one
of
the
Agency­
wide
processes
to
ensure
the
quality,
objectivity,
and
transparency
of
"
influential"
scientific,
financial,
and
statistical
information
under
the
Guidelines.

Some
commenters
expressed
concerns
regarding
application
of
peer
review
in
EPA.
Commenters
suggest
that
current
peer
reviews
are
not
sufficiently
standardized,
independent,
or
consistently
implemented.
Peer
review
is
a
cornerstone
to
EPA's
credibility
and
we
must
ensure
that
the
process
always
works
as
designed.
For
this
reason,
we
conduct
routine
assessments
to
evaluate
and
improve
the
peer
review
process.

Commenters
also
questioned
whether
peer
review
is
an
adequate
means
to
establish
"
objectivity."
We
note
that
OMB
guidelines
specifically
allow
for
the
use
of
formal,
external,
independent
peer
review
to
establish
a
presumption
of
objectivity.
OMB
guidelines
also
state
that
the
presumption
of
objectivity
is
rebuttable,
although
the
burden
of
proof
lies
with
the
complainant.
Some
commenters
asked
for
additional
definitions
for
peer
review
terms.
Our
current
peer
review
policy
is
articulated
in
Peer
Review
and
Peer
Involvement
at
the
U.
S.
Environmental
Protection
Agency.
33
Additional
discussion
regarding
the
application
of
peer­
reviewed
science
is
provided
in
the
discussion
of
comments
on
risk
assessment.

A.
3.2
Scope
and
Applicability
We
received
a
number
of
comments
on
section
1.1
(
What
is
the
Purpose
of
these
Guidelines?)
of
the
draft
Guidelines.
Some
commenters
argued
that
the
Guidelines
should
be
binding
on
EPA,
that
they
are
legislative
rules
rather
than
guidance,
or
that
the
Guidelines
must
be
followed
unless
we
make
a
specific
determination
to
the
contrary.
Others
argued
that
the
Guidelines
should
not
be
binding
or
that
we
should
include
an
explicit
statement
that
the
Guidelines
do
not
alter
substantive
agency
mandates.
Some
suggested
that
our
statements
retaining
discretion
to
differ
from
the
Guidelines
sent
a
signal
that
EPA
was
not
serious
about
information
quality.

With
respect
to
the
nature
of
these
Guidelines,
Section
515
specifies
that
agencies
are
to
issue
"
guidelines."
As
directed
by
OMB's
guidelines,
we
have
issued
our
own
guidelines
containing
nonbinding
policy
and
procedural
guidance.
We
see
no
indication
in
either
the
language
or
general
structure
of
Section
515
that
Congress
intended
EPA's
guidelines
to
be
binding
rules.

We
revised
this
section
(
now
section
1
in
this
revised
draft)
by
adding
a
fuller
explanation
of
how
EPA
intends
to
ensure
the
quality
of
information
it
disseminates.
This
section
includes
language
explaining
the
nature
of
our
Guidelines
as
policy
and
procedural
guidance.
This
language
is
intended
to
give
clear
notice
of
the
nonbinding
legal
effect
of
the
Guidelines.
It
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Appendix
40
notifies
EPA
staff
and
the
public
that
the
document
is
guidance
rather
than
a
substantive
rule
and
explains
how
such
guidance
should
be
implemented.
Although
we
believe
these
Guidelines
would
not
be
judicially
reviewable,
we
agree
that
a
statement
to
this
effect
is
unnecessary
and
have
deleted
it.
In
response
to
comments
that
EPA
clarify
that
the
Guidelines
do
not
alter
existing
legal
requirements,
we
have
made
that
change.
In
light
of
that
change,
we
think
it
is
clear
that
decisions
in
particular
cases
will
be
made
based
on
applicable
statutes,
regulations,
and
requirements,
and
have
deleted
other
text
in
the
paragraph
that
essentially
repeated
that
point.
Elsewhere
in
the
document,
EPA
has
made
revisions
to
be
consistent
with
its
status
as
guidance.

Some
commenters
argued
that
all
EPA
disseminated
information
should
be
covered
by
the
Guidelines
and
that
we
lack
authority
to
"
exempt"
information
from
the
Guidelines.
Others
thought
that
the
coverage
in
EPA's
draft
was
appropriate.
EPA
does
not
view
its
Guidelines
as
establishing
a
fixed
definition
and
then
providing
"
exemptions."
Rather,
our
Guidelines
explain
when
a
distribution
of
information
generally
would
or
would
not
be
considered
disseminated
to
the
public
for
purposes
of
the
Guidelines.
As
we
respond
to
complaints
and
gain
experience
in
implementing
these
Guidelines,
we
may
identify
other
instances
where
information
is
or
is
not
considered
disseminated
for
the
purposes
of
the
Guidelines.

Some
commenters
cited
the
Paperwork
Reduction
Act
(
PRA),
44
U.
S.
C.
3501
et
seq.,
to
support
their
argument
that
the
Guidelines
should
cover
all
information
EPA
makes
public.
EPA's
Guidelines
are
issued
under
Section
515
of
the
Treasury
and
General
Government
Appropriations
Act
for
Fiscal
Year
2001,
which
directs
OMB
to
issue
government­
wide
guidelines
providing
policy
and
procedural
guidance
to
Federal
agencies.
In
turn,
the
OMB
guidelines
provide
direction
and
guidance
to
Federal
agencies
in
issuing
their
own
guidelines.
EPA's
Guidelines
are
intended
to
carry
out
OMB's
policy
on
information
quality.
One
commenter
cited
in
particular
the
term
"
public
information"
used
in
the
PRA
as
evidence
of
Congress's
intent
under
Section
515.
In
EPA's
view,
this
does
not
show
that
Congress
intended
a
specific
definition
for
the
key
terms,
"
information"
and
"
disseminated,"
used
in
Section
515.
In
the
absence
of
evidence
of
Congressional
intent
regarding
the
meaning
of
the
terms
used
in
Section
515,
EPA
does
not
believe
the
PRA
requires
a
change
in
EPA's
Guidelines.

We
agree
with
commenters
who
noted
that
even
if
a
particular
distribution
of
information
is
not
covered
by
the
Guidelines,
the
Guidelines
would
still
apply
to
information
disseminated
in
other
ways.
As
stated
in
section
1.4,
if
information
is
not
initially
covered
by
the
Guidelines,
a
subsequent
distribution
of
that
information
will
be
subject
to
the
Guidelines
if
EPA
adopts,
endorses,
or
uses
it.

Some
commenters
made
specific
recommendations
about
what
should
and
should
not
be
covered
by
the
Guidelines.
In
addition
to
the
specific
recommendations,
some
suggested
that
the
"
scope
and
applicability"
section
was
too
long,
while
others
thought
it
had
an
appropriate
level
of
detail.
Based
on
other
agencies'
guidelines
and
public
comments,
EPA
has
removed
much
of
the
detail
from
the
discussion
of
Guidelines
coverage.
These
revisions
were
intended
to
shorten
and
simplify
the
discussion
without
changing
the
general
scope
of
the
Guidelines.
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Appendix
41
We
revised
our
definition
of
"
information"
in
section
5.3,
in
response
to
a
comment
requesting
that
the
Agency
make
clear
that
information
from
outside
sources
is
covered
by
the
Guidelines
if
EPA
adopts,
endorses,
or
uses
it
to
support
an
Agency
decision
or
position.
In
section
5.4,
we
modified
several
of
the
provisions.
We
added
statements
of
"
intent"
or
similar
language
to
define
the
scope
of
several
of
the
provisions.
Accordingly,
dissemination
would
not
include
distribution
of
information
"
intended"
for
government
employees
or
recipients
of
contracts,
grants,
or
cooperative
agreements.
Nor
would
information
in
correspondence
"
directed
to"
individuals
or
persons
be
covered.
This
recognizes
that
there
may
be
instances
where
EPA
may
use
a
letter
written
to
an
individual
in
a
way
that
indicates
it
is
directed
beyond
the
correspondent
and
represents
a
more
generally
applicable
Agency
policy.
The
Guidelines
would
apply
in
such
a
case.
EPA
has
created
a
category
for
information
of
an
"
ephemeral"
nature,
including
press
releases,
speeches,
and
the
like.
The
intent
was
that
the
Guidelines
should
not
cover
communications
that
merely
serve
as
announcements,
or
for
other
reasons
are
intended
to
be
fleeting
or
of
limited
duration.
Consistent
with
other
agency
guidelines,
we
have
added
language
indicating
that
the
Guidelines
do
not
cover
information
presented
to
Congress,
unless
EPA
simultaneously
disseminates
this
information
to
the
public.

Some
commenters
thought
all
information
from
outside
sources
should
be
covered
by
the
Guidelines,
even
if
EPA
does
not
use,
rely
on,
or
endorse
it.
Others
wished
to
clarify
the
point
at
which
the
Guidelines
cover
information
from
outside
sources.
As
noted
above,
section
1.4
of
the
Guidelines
explains
how
subsequent
distributions
of
information
in
public
filings
may
become
subject
to
the
Guidelines.
We
continue
to
think
that
EPA's
own
public
filings
before
other
agencies
should
not
generally
be
covered
by
the
Guidelines
as
long
as
EPA
does
not
simultaneously
disseminate
them
to
the
public,
since
use
of
this
information
would
be
subject
to
the
requirements
and
policies
of
the
agency
to
which
the
information
is
submitted.

We
received
a
number
of
comments,
including
from
OMB,
arguing
that
the
provision
regarding
information
related
to
adjudicative
processes
was
too
broad,
and
that
the
Guidelines
should
cover
some
or
all
information
related
to
adjudicative
processes,
particularly
administrative
adjudications.
In
addition
to
shortening
this
section,
we
have
limited
this
provision
to
information
in
documents
prepared
specifically
for
an
administrative
adjudication.
This
would
include
decisions,
orders,
findings,
and
other
documents
prepared
specifically
for
the
adjudication.
As
indicated
in
the
Draft
Guidelines,
our
view
is
that
existing
standards
and
protections
in
administrative
adjudications
would
generally
be
adequate
to
assure
the
quality
of
information
in
administrative
adjudications
and
to
provide
an
adequate
opportunity
to
contest
decisions
on
the
quality
of
information.
For
example,
in
permitting
proceedings,
parties
may
submit
comments
on
the
quality
of
information
EPA
prepares
for
the
permit
proceeding,
and
judicial
review
is
available
based
on
existing
statutes
and
regulations.
Narrowing
the
provision
to
information
prepared
specifically
for
the
adjudication
should
make
clear
that
the
Guidelines
would
not
generally
provide
parties
with
additional
avenues
of
challenge
or
appeal
during
adjudications,
but
would
still
apply
to
a
separate
distribution
of
information
where
EPA
adopts,
endorses,
or
uses
the
information,
such
as
when
EPA
disseminates
it,
on
the
Internet,
or
in
a
rulemaking,
or
guidance
document.
When
we
intend
to
adopt
information
such
as
models
or
risk
assessments
for
use
in
a
class
of
cases
or
determinations
(
e.
g.,
for
use
in
all
determinations
under
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Appendix
42
a
particular
regulatory
provision),
EPA
often
disseminates
this
information
separately
and
in
many
instances
requests
public
comment
on
it.
Accordingly,
it
is
not
clear
that
there
would
be
many
instances
where
persons
who
are
concerned
about
information
prepared
specifically
for
an
adjudication
would
not
have
an
opportunity
to
contest
the
quality
of
information.

We
respectfully
disagree
with
a
commenter's
recommendation
that
regulatory
limits
established
by
EPA
should
be
subject
to
the
Guidelines.
The
Guidelines
apply
to
information
disseminated
by
EPA,
not
to
regulatory
standards
or
other
Agency
decisions
or
policy
choices.
In
response
to
comments
regarding
information
disseminated
in
rulemakings
and
other
matters
subject
to
public
comment,
EPA
considers
that
this
information
would
be
disseminated
within
the
meaning
of
the
Guidelines,
although
we
would
generally
treat
complaints
regarding
that
information
procedurally
like
other
comments
on
the
rulemaking
or
other
matter.

A.
3.3
Sources
of
Information
We
received
many
comments
on
how
the
Guidelines
apply
to
external
parties,
the
shared
quality
responsibilities
between
EPA
and
external
parties,
and
specific
EPA
responsibilities
when
using
or
relying
on
information
collected
or
compiled
by
external
parties.

EPA
roles:
Some
commenters
emphasized
that
ensuring
quality
of
information
at
the
point
of
dissemination
is
no
substitute
for
vigorous
efforts
by
EPA
to
receive
quality
information
in
the
first
place
and
therefore
for
information
providers
to
produce
quality
information.
One
commenter
stated
that
EPA
cannot
be
responsible
for
all
aspects
of
the
quality
of
the
information
we
disseminate.
In
response
to
this
and
other
comments,
we
have
provided
additional
language
in
these
Guidelines
on
the
various
roles
that
EPA
assumes
in
either
ensuring
the
quality
of
the
information
we
disseminate
or
ensuring
the
integrity
of
information
EPA
distributes.
One
comment
suggested
that
we
mention
the
role
of
the
National
Environmental
Information
Exchange
Network
in
ensuring
information
integrity,
which
we
have
done
in
section
2.4
of
the
Guidelines.

Assessment
factors:
Overall,
public
input
was
positive
and
welcoming
of
our
proposal
to
develop
assessment
factors
to
evaluate
the
quality
of
information
generated
by
third
parties.
A
few
commenters
offered
their
involvement
in
the
development
of
these
factors,
their
advice
on
how
to
develop
such
factors,
and
some
examples
of
what
assessment
factors
we
should
consider.
EPA
staff
have
provided
such
comments
to
the
EPA
Science
Policy
Council
workgroup
that
was
charged
with
developing
the
assessment
factors.
EPA
welcomes
stakeholder
input
in
the
development
of
these
factors
and
published
draft
assessment
factors
for
public
comment
in
September
2002.

Coverage
of
State
Information:
Some
commenters
suggested
that
our
Guidelines
must
apply
to
all
information
disseminated
by
EPA,
including
information
submitted
to
us
by
States.
Whereas
some
commenters
stressed
that
the
quality
of
information
received
by
EPA
is
the
responsibility
of
the
providers,
others
expressed
concern
about
the
potential
impact
that
EPA's
Guidelines
could
have
on
States.
We
believe
it
is
important
to
differentiate
between
information
that
we
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Appendix
43
generate
and
data
or
information
generated
by
external
parties,
including
States.
State
information,
when
submitted
to
EPA,
may
not
be
covered
by
these
Guidelines,
but
our
subsequent
use
of
the
information
may
in
fact
be
covered.
We
note,
however,
that
there
may
be
practical
limitations
on
the
type
of
corrective
action
that
may
be
taken,
since
EPA
does
not
intend
to
alter
information
submitted
by
States.
However,
EPA
does
intend
to
work
closely
with
our
State
counterparts
to
ensure
and
maximize
the
quality
of
information
that
EPA
disseminates.
Furthermore,
one
commenter
stated
that
if
regulatory
information
is
submitted
to
an
authorized
or
delegated
State
program,
then
the
State
is
the
primary
custodian
of
the
information
and
the
Guidelines
would
not
cover
that
information.
We
agree
with
that
statement.

We
also
received
comments
regarding
the
use
of
labels,
or
disclaimers,
to
notify
the
public
whether
information
is
generated
by
EPA
or
an
external
party.
We
agree
that
disclaimers
and
other
notifications
should
be
used
to
explain
the
status
of
information
wherever
possible,
and
we
are
developing
appropriate
language
and
format.

A
statement
regarding
Paperwork
Reduction
Act
clearance
submissions
has
been
added
in
response
to
comment
by
OMB.

A.
3.4
Influential
Information
EPA
received
a
range
of
comments
on
its
definition
of
"
influential."
Below
we
provide
a
summary
of
the
comments
raised
and
EPA's
response.

Several
commenters
generally
assert
that
the
definition
is
too
narrow.
Other
commenters
indicated
that
under
EPA's
draft
definition,
only
Economically
Significant
actions,
as
defined
in
Executive
Order
12866,
or
only
Economically
Significant
actions
and
information
disseminated
in
support
of
top
Agency
actions,
are
considered
"
influential."
We
disagree.
To
demonstrate
the
broad
range
of
activities
covered
by
our
adoption
of
OMB's
definition,
we
reiterate
the
definition
below
and
include
an
example
of
each
type
of
action,
to
illustrate
the
breadth
of
our
definition.
"
Influential,"
when
used
in
the
phrase
"
influential
scientific,
financial,
or
statistical
information,"
means
that
the
Agency
can
reasonably
determine
that
dissemination
of
the
information
will
have
or
does
have
a
clear
and
substantial
impact
on
important
public
policies
or
important
private
sector
decisions.
We
will
generally
consider
the
following
classes
of
information
to
be
influential:
information
disseminated
in
support
of
top
Agency
actions;
information
disseminated
in
support
of
"
economically
significant"
actions;
major
work
products
undergoing
peer
review;
and
other
disseminated
information
that
will
have
or
does
have
a
clear
and
substantial
impact
(
i.
e.,
potential
change
or
impact)
on
important
public
policies
or
important
private
sector
decisions
as
determined
by
EPA
on
a
case­
by­
case
basis.
In
general,
influential
information
would
be
the
scientific,
financial
or
statistical
information
that
provides
a
substantial
basis
for
EPA's
position
on
key
issues
in
top
Agency
actions
and
Economically
Significant
actions.
If
the
information
provides
a
substantial
basis
for
EPA's
position,
EPA
believes
it
would
generally
have
a
clear
and
substantial
impact.
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Appendix
44
Top
Agency
actions:
An
example
of
a
top
Agency
action
is
the
review
of
the
National
Ambient
Air
Quality
Standards
(
NAAQS)
for
Particulate
Matter.
Under
the
Clean
Air
Act,
EPA
is
to
periodically
review
(
1)
the
latest
scientific
knowledge
about
the
effects
on
public
health
and
public
welfare
(
e.
g.,
the
environment)
associated
with
the
presence
of
such
pollutants
in
the
ambient
air
and
(
2)
the
standards,
which
are
based
on
this
science.
The
Act
further
directs
that
the
Administrator
shall
make
any
revisions
to
the
standards
as
may
be
appropriate,
based
on
the
latest
science,
that
in
her
judgment
are
requisite
to
protect
the
public
health
with
an
adequate
margin
of
safety
and
to
protect
the
public
welfare
from
any
known
or
anticipated
adverse
effects.
The
standards
establish
allowable
levels
of
the
pollutant
in
the
ambient
air
across
the
United
States,
and
States
must
development
implementation
plans
to
attain
the
standards.
The
PM
NAAQS
were
last
revised
in
1997,
and
the
next
periodic
review
is
now
being
conducted.

"
Economically
significant"
rules:
An
example
of
a
rule
found
to
be
economically
significant
is
the
Disposal
of
Polychlorinated
Biphenyls
(
PCBs)
Final
Rule.
In
1998,
EPA
amended
its
rules
under
the
Toxic
Substances
Control
Act
(
TSCA),
which
addresses
the
manufacture,
processing,
distribution
in
commerce,
use,
cleanup,
storage
and
disposal
of
PCBs.
This
rule
provides
flexibility
in
selecting
disposal
technologies
for
PCB
wastes
and
expands
the
list
of
available
decontamination
procedures;
provides
less
burdensome
mechanisms
for
obtaining
EPA
approval
for
a
variety
of
activities;
clarifies
and/
or
modifies
certain
provisions
where
implementation
questions
have
arisen;
modifies
the
requirements
regarding
the
use
and
disposal
of
PCB
equipment;
and
addresses
outstanding
issues
associated
with
the
notification
and
manifesting
of
PCB
wastes
and
changes
in
the
operation
of
commercial
storage
facilities.
EPA
would
consider
the
information
that
provides
the
principal
basis
for
this
rule
to
be
influential
information.

Peer
reviewed
work
products:
An
example
of
a
major
work
product
undergoing
peer
review
is
the
IRIS
Documentation:
Reference
Dose
for
Methylmercury.
Methylmercury
contamination
is
the
basis
for
fish
advisories.
It
is
necessary
to
determine
an
intake
to
humans
that
is
without
appreciable
risk
in
order
to
devise
strategies
for
decreasing
mercury
emissions
into
the
environment.
After
EPA
derived
a
reference
dose
(
RfD)
of
0.0001
mg/
kg­
day
in
1995,
industry
argued
that
it
was
not
based
on
sound
science.
Congress
ordered
EPA
to
fund
an
National
Research
Council/
National
Academy
of
the
Sciences
panel
to
determine
whether
our
RfD
was
scientifically
justifiable.
The
panel
concluded
that
the
0.0001
mg/
kg­
day
was
an
appropriate
RfD,
based
on
newer
studies
than
the
1995
RfD.
The
information
in
this
document
was
evaluated,
incorporated,
and
subjected
to
comment
by
the
Office
of
Water,
where
it
contributed
in
large
part
to
Chapter
4
of
Drinking
Water
Criteria
for
the
Protection
of
Human
Health:
Methylmercury
(
EPA/
823/
R­
01/
001)
January
2001.
The
peer
review
mechanism
was
an
external
peer
review
workshop
and
public
comment
session
held
on
November
15,
2000,
accompanied
by
a
public
comment
period
from
October
30
to
November
29,
2000.

Case­
by­
base
determination
 
PBT
Chemicals
Rule:
An
example
of
a
case­
by­
case
determination
is
the
Guidance
Document
for
Reporting
Releases
and
Other
Waste
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Appendix
45
Management
Activities
of
Toxic
Chemicals:
Dioxin
and
Dioxin­
like
Compounds
(
December,
2000).
In
a
final
rule
published
October
29,
1999,
EPA
lowered
the
reporting
thresholds
for
certain
persistent
bioaccumulative
toxic
(
PBT)
chemicals
that
are
subject
to
reporting
under
Section
313
of
the
Emergency
Planning
and
Community
Right­
to­
Know
Act
of
1986
(
EPCRA)
and
Section
6607
of
the
Pollution
Prevention
Act
of
1990
(
PPA).
We
also
added
a
category
of
dioxin
and
dioxin­
like
compounds
to
the
EPCRA
Section
313
list
of
toxic
chemicals
and
established
a
0.1
gram
reporting
threshold
for
the
category.
In
addition,
EPA
added
certain
other
PBT
chemicals
to
the
EPCRA
Section
313
list
of
toxic
chemicals
and
established
lower
reporting
thresholds
for
these
chemicals.
As
a
result
of
this
rulemaking,
we
developed
a
guidance
document
on
the
reporting
requirements
for
the
dioxin
and
dioxin­
like
compounds
category,
as
well
as
a
number
of
other
guidance
documents.
The
dioxin
guidance
document
provides
guidance
on
how
to
estimate
annual
releases
and
other
waste
management
quantities
of
dioxin
and
dioxin­
like
compounds
to
the
environment
from
certain
industries
and
industrial
activities.
Due
to
the
high
interest
level
of
stakeholders,
we
solicited
public
comments
on
the
draft
guidance
document
and
formed
a
workgroup
of
interested
stakeholders.
The
workgroup
reviewed
all
public
comments,
provided
their
own
comments,
and
then
reviewed
and
commented
on
the
final
draft.

Case­
by­
case
determination
 
National
Water
Quality
Inventory
Report:
A
second
example
of
a
case­
by­
case
determination
is
the
National
Water
Quality
Inventory
Report
to
Congress.
The
National
Water
Quality
Inventory
Report
to
Congress
is
a
biennial
report
to
Congress
and
the
public
about
the
quality
of
our
nation's
waters.
It
is
prepared
under
Section
305
(
b)
of
the
Clean
Water
Act
(
CWA),
which
requires
States
and
other
jurisdictions
to
assess
the
health
of
their
waters
and
the
extent
to
which
water
quality
supports
State
water
quality
standards
and
the
basic
goals
of
the
CWA.
States'
Section
305
(
b)
assessments
are
an
important
component
of
their
water
resource
management
programs.
These
assessments
help
States:
implement
their
water
quality
standards
by
identifying
healthy
waters
that
need
to
be
maintained
and
impaired
waters
that
need
to
be
restored,
prepare
their
Section
303
(
d)
lists
of
impaired
waters,
develop
restoration
strategies
such
as
total
maximum
daily
loads
and
source
controls,
and
evaluate
the
effectiveness
of
activities
undertaken
to
restore
impaired
waters
and
protect
healthy
waters.

A
number
of
commenters
said
that
EPA
created
a
limited
definition
of
what
types
of
information
are
to
be
considered
"
influential,"
and
that
we
have
no
rational
basis
to
do
so.
A
number
of
commenters
also
stated
that
"
all
Agency
information
should
be
considered
influential";
that
"
all
data
relied
upon
by
the
Agency
should
meet
a
high
standard
of
quality
regardless
of
the
type";
or
that
"`
influential'
information
includes
information
used
to
support
any
EPA
action,
not
just
`
top'
Agency
actions."
EPA
followed
OMB's
guidelines
in
establishing
a
definition
for
"
influential"
information
that
was
not
all­
encompassing.
OMB
stated
"
the
more
important
the
information,
the
higher
the
quality
standards
to
which
it
should
be
held,
for
example,
in
those
situations
involving
"
influential
scientific,
financial
or
statistical
information...".
OMB
narrowed
the
definition
of
"
influential"
in
their
final
guidance
as
follows:
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Appendix
46
In
this
narrower
definition,
"
influential",
when
used
in
the
phrase
"
influential
scientific,
financial,
or
statistical
information",
is
amended
to
mean
that
"
the
agency
can
reasonably
determine
that
dissemination
of
the
information
will
have
or
does
have
a
clear
and
substantial
impact
on
important
public
policies
or
important
private
sector
decisions"
(
67
FR
8455).

OMB
also
amended
their
definition
to
say
that
"
each
agency
is
authorized
to
define
"
influential"
in
ways
appropriate
for
it
given
the
nature
and
multiplicity
of
issues
for
which
the
agency
is
responsible"
(
67
FR
8455).
We
adopted
OMB's
"
influential"
definition.
Once
the
Agency
reviewed
the
wide
range
of
information
disseminated
to
the
public,
such
as
major
rulemakings,
risk
assessments,
rule
related
guidance,
health
advisories,
annual
reports,
fact
sheets,
and
coloring
books,
it
became
apparent
that
there
were
reasons
to
distinguish
between
"
influential"
information
and
other
information.
EPA
adopted
OMB's
definition
for
"
influential"
and
used
types
of
information
the
Agency
disseminates
to
further
explain
what
information
is
included.

Another
commenter
suggested
that
EPA
should
not
indicate
whether
disseminated
information
is
"
influential"
when
it
is
first
disseminated
but
should
wait
to
designate
information
as
"
influential"
until
either
an
information
correction
request
is
made
or
a
final
agency
action
is
taken.
We
intend
to
consider
this
point,
as
well
as
other
comments
made
about
when
disseminated
information
becomes
influential,
as
the
Agency
implements
the
Guidelines.

One
commenter
suggests
that
the
definition
of
the
term
"
influential"
should
be
more
narrow.
Specifically,
the
commenter
states
the
following:

Within
the
relatively
narrow
sphere
of
"
disseminated"
information,
an
agency
should
reserve
the
designation
of
"
influential"
for
information
disseminated
in
support
of
agency
actions
that
are
"
major"
regulations
under
Executive
Order
12866,
provide
a
"
significant"
opportunity
to
advance
the
agency's
mandate
by
other
means,
or
involve
precedent­
setting
or
reasonably
controverted
issues.
This
designation
recognizes
that
procedures
to
promote
the
quality
of
information
have
significant
costs,
and
that
the
most
significant
(
and
therefore
the
most
costly)
of
such
procedures
should
be
reserved
for
information
that
is
the
most
important
in
terms
of
the
agency's
mission.

EPA
agrees
with
the
commenter
that
there
are
significant
costs
associated
with
ensuring
that
information
disseminated
by
the
Agency
is
of
high
quality.
Consequently,
EPA
chose
a
definition
of
the
term
"
influential"
to
cover
information
that,
when
disseminated,
will
result
in
a
clear
and
substantial
impact
on
important
public
policies
and
private
sector
decisions.
We
believe
that
this
definition
balances
the
costs
associated
with
implementing
the
Guidelines,
the
need
to
ensure
high
quality
information,
and
the
Agency's
mission
to
protect
human
health
and
safeguard
the
natural
environment.

Several
commenters
indicated
that
it
is
inappropriate
for
EPA
to
base
its
definition
of
"
influential"
on
categories
of
actions.
They
suggest
that
the
definition
be
based
instead
on
the
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Appendix
47
content
of
the
information.
We
consider
our
definition
to
be
based
on
information
content,
given
that
those
categories
of
disseminated
information
we
defined
as
influential
are
those
that
EPA
can
reasonably
determine
will
or
do
have
a
clear
and
substantial
impact
on
important
public
policies
or
private
sector
decisions.
We
note
here
that,
in
addition
to
the
specific
classes
of
disseminated
information
we
have
defined
as
"
influential,"
EPA
has
reiterated
the
"
case­
bycase
portion
of
the
OMB
"
influential"
definition.
This
general
provision
is
intended
to
capture
disseminated
information,
based
on
its
content,
that
would
not
otherwise
rise
to
the
level
of
"
influential"
under
the
other
parts
of
our
definition
(
i.
e.,
top
Agency
actions,
Economically
Significant
actions,
major
peer
reviewed
products).

Several
commenters
assert
that
EPA
should
categorically
state
that
certain
specific
types
of
disseminated
information
products
are
influential,
and
that
we
should
categorically
state
that
certain
specific
types
of
disseminated
information
products
are
not
influential.
Given
the
vast
array
of
information
disseminated
by
the
Agency,
and
given
the
fact
that
certain
information
may
have
a
clear
and
substantial
impact
on
important
public
policies
or
private
sector
decisions
at
one
time,
but
not
have
such
an
impact
later
on
(
and
vice
versa),
classifying
types
of
information
as
"
influential"
or
otherwise
upfront
is
difficult
and
could
be
misleading.
We
intend
to
rely
on
our
definition
in
determining
whether
specific
types
of
disseminated
information
products
are
to
be
considered
"
influential"
for
purposes
of
the
Guidelines.

A.
3.5
Reproducibility
Some
commenters
stated
that
there
needs
to
be
more
clarity
in
the
definition
of
"
reproducibility"
and
related
concepts.
We
have
tried
to
provide
definitions
that
are
consistent
with
OMB
guidelines.
Also,
our
Guidelines
now
include
that
EPA
intends
to
ensure
reproducibility
for
disseminated
original
and
supporting
data
according
to
commonly
accepted
scientific,
financial,
or
statistical
standards.
Many
commenters
thought
there
should
be
some
kind
of
method
to
consider
reproducibility
when
proprietary
models,
methods,
designs,
and
data
are
used
in
a
dissemination.
Some
commenters
discourage
all
use
of
proprietary
models;
others
suggest
proprietary
model
use
be
minimized
with
application
limited
to
situations
in
which
it
is
absolutely
necessary.
We
understand
this
concern,
but
note
that
there
are
other
factors
that
are
appropriately
considered
when
deciding
whether
to
use
proprietary
models,
including
feasibility
and
cost
considerations
(
e.
g.,
it
may
be
more
cost­
effective
for
the
Agency
to
use
a
proprietary
model
in
some
situations
than
to
develop
its
own
model).
In
cases
where
the
Agency
relies
on
proprietary
models,
these
model
applications
are
still
subject
to
our
Peer
Review
Policy.
Further,
as
recently
directed
by
the
Administrator,
the
Agency's
Council
on
Regulatory
Environmental
Modeling
is
now
revitalizing
its
development
of
principles
for
evaluating
the
use
of
environmental
models
with
regard
to
model
validation
and
certification
issues,
building
on
current
good
modeling
practices.
In
addition,
these
Guidelines
provide
for
the
use
of
especially
rigorous
"
robustness
checks"
and
documentation
of
what
checks
were
undertaken.
These
steps,
along
with
transparency
about
the
sources
of
data
used,
various
assumptions
employed,
analytic
methods
applied,
and
statistical
procedures
employed
should
assure
that
analytic
results
are
"
capable
of
being
substantially
reproduced."
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Appendix
48
Regarding
robustness
checks,
commenters
were
concerned
that
the
EPA
did
not
use
the
term
"
especially
rigorous
robustness
checks."
We
have
modified
our
Guidelines
to
include
this
term.
Some
commenters
speculated
on
the
ability
of
the
Agency's
Peer
Review
program
to
meet
the
intent
of
the
Guidelines
and
were
concerned
about
the
process
to
rebut
a
peer
review
used
to
support
the
objectivity
demonstration
for
disseminated
information.
Our
Peer
Review
program
has
been
subject
to
external
review
and
we
routinely
verify
implementation
of
the
program.
Affected
persons
wishing
to
rebut
a
formal
peer
review
may
do
so
using
the
complaint
resolution
process
in
these
Guidelines,
provided
that
the
information
being
questioned
is
considered
to
be
"
disseminated"
according
to
the
Guidelines.

Regarding
analytic
results,
some
commenters
indicated
that
the
transparency
factors
identified
by
EPA
(
section
6.3
of
the
Guidelines)
are
not
a
complete
list
of
the
items
that
would
be
needed
to
demonstrate
a
higher
degree
of
quality
for
influential
information.
EPA
agreed
with
the
list
of
four
items
that
was
initially
provided
by
the
OMB
and
recognizes
that,
in
some
cases,
additional
information
regarding
disseminated
information
would
facilitate
increased
quality.
However,
given
the
variety
of
information
disseminated
by
the
Agency,
we
cannot
reasonably
provide
additional
details
for
such
a
demonstration
at
this
time.
Also,
in
regards
to
laboratory
results,
which
were
mentioned
by
several
commenters,
these
Guidelines
are
not
the
appropriate
place
to
set
out
for
the
science
community
EPA's
view
of
what
constitutes
adequate
demonstration
of
test
method
validation
or
minimum
quality
assurance
and
quality
control.
Those
technical
considerations
should
be
addressed
in
the
appropriate
quality
planning
documentation
or
in
regulatory
requirements.

EPA
has
developed
general
language
addressing
the
concept
of
reproducibility
and
may
provide
more
detail
after
appropriate
consultation
with
scientific
and
technical
communities,
as
called
for
by
OMB
in
its
guidelines.
We
have
already
begun
to
consult
relevant
scientific
and
technical
experts
within
the
Agency,
and
also
have
planned
an
expedited
consultation
with
EPA's
Science
Advisory
Board
(
SAB)
on
October
1,
2002.
Based
on
these
initial
consultations,
EPA
may
seek
additional
input
from
the
SAB
in
2003.
These
consultations
will
allow
EPA
to
constructively
and
appropriately
refine
the
application
of
existing
policies
and
procedures,
to
further
improve
reproducibility.
In
the
interim,
EPA
intends
to
base
the
reproducibility
of
disseminated
original
and
supporting
data
on
commonly
accepted
scientific,
financial,
or
statistical
standards.

A.
3.6
Influential
Risk
Assessment
General
Risk
Assessment
Risk
assessment
is
a
process
where
information
is
analyzed
to
determine
if
an
environmental
hazard
might
cause
harm
to
exposed
persons
and
ecosystems
(
paraphrased
from
Risk
Assessment
in
the
Federal
Government,
National
Research
Council,
1983).
That
is:

Risk
=
hazard
x
exposure
For
a
chemical
or
other
stressor
to
be
"
risky,"
it
must
have
both
an
inherent
adverse
effect
on
an
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Appendix
49
organism,
population,
or
other
endpoint
and
it
must
be
present
in
the
environment
at
concentrations
and
locations
that
an
organism,
population,
or
other
endpoint
is
exposed
to
the
stressor.
Risk
assessment
is
a
tool
to
determine
the
likelihood
of
harm
or
loss
of
an
organism,
population,
or
other
endpoint
because
of
exposure
to
a
chemical
or
other
stressor.
To
assist
those
who
must
make
risk
management
decisions,
risk
assessments
include
discussions
on
uncertainty,
variability
and
the
continuum
between
exposure
and
adverse
effects.

Risk
assessments
may
be
performed
iteratively,
with
the
first
iteration
employing
protective
(
conservative)
assumptions
to
identify
possible
risks.
Only
if
potential
risks
are
identified
in
a
screening
level
assessment
is
it
necessary
to
pursue
a
more
refined,
data­
intensive
risk
assessment.
The
screening
level
assessments
may
not
result
in
"
central
estimates"
of
risk
or
upper
and
lower­
bounds
of
risks.
Nevertheless,
such
assessments
may
be
useful
in
making
regulatory
decisions,
as
when
the
absence
of
concern
from
a
screening
level
assessment
is
used
(
along
with
other
information)
to
approve
the
new
use
of
a
pesticide
or
chemical
or
to
decide
whether
to
remediate
very
low
levels
of
waste
contamination.
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
34
Safe
Drinking
Water
Act
Amendments
of
1996,
42
U.
S.
C.
300g­
1(
b)(
3)(
A)
&
(
B).

35
In
section
III.
3.
ii.
C.
of
its
guidelines,
OMB
states
that:
"
With
regard
to
analysis
of
risks
to
human
health,
safety
and
the
environment
maintained
or
disseminated
by
the
agencies,
agencies
shall
either
adopt
or
adapt
the
equality
principles
applied
by
Congress
to
risk
information
used
and
disseminated
pursuant
to
the
Safe
Drinking
Water
Act
Amendments
of
1996
(
42
U.
S.
C.
300g­
1(
b)(
3)(
A)
&
(
B)).
Agencies
responsible
for
dissemination
of
vital
health
and
medical
information
shall
interpret
the
reproducibility
and
peer­
review
standards
in
a
manner
appropriate
to
assuring
the
timely
flow
of
vital
information
from
agencies
to
medical
providers,
patients,
health
agencies,
and
the
public.
Information
quality
standards
may
be
waived
temporarily
by
agencies
under
urgent
situations
(
e.
g.,
imminent
threats
to
public
health
or
homeland
security)
in
accordance
with
the
latitude
specified
in
agency­
specific
guidelines".

36Because
the
assessment
of
"
environmental
risk"
is
being
distinguished
in
OMB's
adaptation
of
the
SDWA
quality
principles
from
"
human
health
risk",
the
term
"
environmental
risk"
as
used
in
these
Guidelines
does
not
directly
involve
human
health
concerns.
In
other
words,
"
environmental
risk
assessment"
is,
in
this
case,
the
equivalent
to
what
EPA
commonly
refers
to
as
"
ecological
risk
assessment".

3740
CFR
part
160
for
FIFRA
and
40
CFR
part
792
for
TSCA.

Appendix
50
OMB
Guidelines
In
its
guidelines
OMB
stated
that,
with
respect
to
influential
information
regarding
health,
safety
or
environmental
risk
assessments,
agencies
should
either
adopt
or
adapt
the
quality
principles
in
the
Safe
Drinking
Water
Act
(
SDWA)
Amendments
of
1996.34,35
In
the
background
section
of
the
OMB
guidelines,
OMB
explains
that
"
the
word
`
adapt'
is
intended
to
provide
agencies
flexibility
in
applying
these
principles
to
various
types
of
risk
assessment."

Guidelines
Development
Consideration
EPA
carefully
and
practically
developed
the
adaptation
of
the
SDWA
quality
principles
using
our
considerable
experience
conducting
human
health
and
ecological36
risk
assessments
as
well
as
using
our
existing
policies
and
guidance.

EPA
conducts
many
risk
assessments
every
year.
Some
of
these
are
screening
level
assessments
based
on
scientific
experts'
judgments
using
conservative
assumptions
and
available
data
and
can
involve
human
health,
safety,
or
environmental
risk
assessments.
Such
screening
assessments
provide
useful
information
that
are
sufficient
for
regulatory
purposes
in
instances
where
more
elaborate,
quantitative
assessments
are
unnecessary.
For
example,
such
assessments
could
indicate,
even
with
conservative
assumption,
the
level
of
risk
does
not
warrant
further
investigation.
Other
risk
assessments
are
more
detailed
and
quantitative
and
are
based
on
research
and
supporting
data
that
are
generated
outside
EPA.
For
example,
pesticide
reviews
are
based
on
scientific
studies
conducted
by
registrants
in
accordance
with
our
regulations
and
guidance
documents.
Our
test
guidelines
and
Good
Laboratory
Practices
(
GLPs)
37
describe
sound
scientific
practices
for
conducting
studies
needed
to
assess
human
and
environmental
hazards
and
exposures.
Such
studies
are
not
required
to
be
peer­
reviewed.
Risk
assessments
based
on
these
studies
can
include
occupational,
dietary,
and
environmental
exposures.
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
38http://
www.
epa.
gov/
OSP/
spc/
rcpolicy.
htm
39
Ibid.

40US
EPA(
1998).
Guidelines
for
ecological
risk
assessment
(
Federal
Register
63(
93):
26846­
26924).
http://
www.
epa.
gov/
ncea/
raf.

41US
EPA
(
1992).
Guidelines
For
Exposure
Assessment.
Federal
Register
57(
104):
22888­
22938.
http://
www.
epa.
gov/
ncea/
raf/.

42US
EPA
(
1998).
Guidelines
For
Neurotoxicity
Risk
Assessment.
Federal
Register
63(
93):
26926­
26954.
http://
www.
epa.
gov/
ncea/
raf/.

43US
EPA
(
1996).
Guidelines
For
Reproductive
Toxicity
Risk
Assessment.
Federal
Register
61(
212):
56274­
56322.
http://
www.
epa.
gov/
ncea/
raf
.

44
The
Office
of
Solid
Waste
and
Emergency
Response
has
developed
Tools
for
Ecological
Risk
Assessment
for
Superfund
Risk
Assessment.
One
example
is
the
Ecological
Risk
Assessment
Guidance
for
Superfund:
Process
for
Designing
and
Conducting
Ecological
Risk
Assessments
­
Interim
Final.
http://
www.
epa.
gov/
oerrpage/
superfund/
programs/
risk/
ecorisk/
ecorisk.
htm
http://
www.
epa.
gov/
oerrpage/
superfund/
programs/
risk/
tooleco.
htm
Appendix
51
The
results
of
these
risk
assessments
are
conducted
and
presented
to
policy
makers
to
inform
their
risk
management
decisions.
EPA
currently
has
numerous
policies
that
provide
guidance
to
internal
risk
assessors
on
how
to
conduct
a
risk
assessment
and
characterize
risk.
The
EPA
Risk
Characterization
Policy38
and
associated
guidelines
are
designed
to
ensure
that
critical
information
from
each
stage
of
a
risk
assessment
is
used
in
forming
conclusions
about
risk
and
that
this
information
is
communicated
from
risk
assessors
to
policy
makers.

EPA
Existing
Policies
and
Guidance
Current
EPA
guidance
and
policies
incorporate
quality
principles.
These
are
designed
to
ensure
that
critical
information
from
each
stage
of
a
risk
assessment
is
used
in
forming
conclusions
about
risk
and
that
this
information
is
communicated
from
risk
assessors
to
policy
makers.
One
example
is
the
EPA
Risk
Characterization
Policy39
which
provides
a
single,
centralized
body
of
risk
characterization
implementation
guidance
to
help
EPA
risk
assessors
and
risk
managers
make
the
risk
characterization
process
transparent
and
risk
characterization
products
clear,
consistent
and
reasonable
(
TCCR).
These
principles
have
been
included
in
other
Agency
risk
assessment
guidance,
such
as
the
Guidelines
for
Ecological
Risk
Assessment.
40
Other
examples
of
major,
overarching
guidelines
for
risk
assessments
include:
Guidelines
For
Exposure
Assessment
41,
Guidelines
For
Neurotoxicity
Risk
Assessment,
42
and
Guidelines
For
Reproductive
Toxicity
Risk
Assessment.
43
Each
of
these
documents
has
undergone
external
scientific
peer
review
as
well
as
public
comment
prior
to
publication.
Additionally,
individual
EPA
offices
have
developed
more
specific
risk
assessment
policies
to
meet
the
particular
needs
of
the
programs
and
statutes
under
which
they
operate.
44
EPA's
commitment
to
sound
science
is
evidenced
by
our
ongoing
efforts
to
develop
and
continually
improve
Agency
guidance
for
risk
assessment.
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
4551
FR
33992­
34054,
24
September
1986.

46Framework
For
Ecological
Risk
Assessment,
U.
S.
EPA,
Risk
Assessment
Forum,
1992,
EPA/
630/
R­
92/
001.

47Guidelines
For
Ecological
Risk
Assessment,
U.
S.
EPA,
Risk
Assessment
Forum,
1998,
EPA/
630/
R­
95/
002F.
http://
cfpub.
epa.
gov/
ncea/
cfm/
ecorsk.
cfm
Appendix
52
EPA's
Experience
Conducting
Risk
Assessments
The
first
EPA
human
health
risk
assessment
guidelines45
were
issued
in
1986.
In
1992,
the
Agency
produced
a
Framework
for
Ecological
Risk
Assessment46
which
was
replaced
by
the
1998
Ecological
Risk
Assessment
Guidelines.
47
As
emphasized
elsewhere
in
this
document,
the
statutes
administered
by
EPA
are
diverse.
Although
the
majority
of
risk
assessments
conducted
within
the
Agency
are
for
chemical
stressors,
we
also
assess
risks
to
biological
and
physical
stressors.
In
addition
to
risk
assessment
guidelines,
both
the
EPA
Science
Policy
Council
and
the
EPA
Risk
Assessment
Forum
have
coordinated
efforts
to
address
the
complex
issues
related
to
data
collection
and
analysis
for
hazard
and
exposure
assessments.
Thus,
the
Agency
has
considerable
experience
in
conducting
both
screening
level
and
in­
depth
assessments
for
a
wide
array
of
stressors.

Most
environmental
statutes
obligate
EPA
to
act
to
prevent
adverse
environmental
and
human
health
impacts.
For
many
of
the
risks
that
we
must
address,
data
are
sparse
and
consensus
about
assumptions
is
rare.
In
the
context
of
data
quality,
we
seek
to
strike
a
balance
among
fairness,
accuracy,
and
efficient
implementation.
Refusing
to
act
until
data
quality
improves
can
result
in
substantial
harm
to
human
health,
safety,
and
the
environment.

Public
Comments
We
received
a
range
of
public
and
stakeholder
comments
on
the
adaptation
of
the
SDWA
principles
for
"
influential"
human
health,
safety,
and
environmental
risk
assessments
that
are
disseminated
by
EPA.
Some
commenters
stated
that
we
should
adopt
the
SDWA
quality
principles
for
human
health
risk,
safety
and
environmental
risk
assessments.
Many
commenters
sought
clarification
on
reasons
for
EPA's
adaptation
of
the
SDWA
quality
principles
for
human
health
risk
assessments
and
additional
information
on
how
we
plan
to
address
this
process.
Others
urged
us
to
adapt
the
SDWA
principles
rather
than
adopt,
because
of
certain
elements
in
the
SDWA
principles
that
may
not
be
applicable
to
all
risk
assessments
such
as
a
"
central
estimate
of
human
risk
for
the
specific
populations
affected."
Others
stated
that
we
should
neither
adapt
nor
adopt
SDWA
principles
because
the
"
Data
Quality
Act"
does
not
authorize
importing
decisional
criteria
into
statutory
provisions
where
they
do
not
apply.
The
decisional
criteria
set
forth
in
SDWA
are
expressly
limited
to
SDWA.
We
also
received
comments
at
a
level
of
detail
that
are
more
appropriate
for
implementation
of
the
Guidelines
than
for
the
formulation
of
the
Guidelines.
These
include
comments
regarding
the
use
of
clinical
human
test
data,
and
comments
regarding
the
use
of
particular
types
of
assumptions
in
risk
assessments.
To
the
extent
that
an
affected
person
believes
that
our
use
of
data
or
assumptions
in
a
particular
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Appendix
53
dissemination
of
information
is
inconsistent
with
these
Guidelines,
the
issue
can
be
raised
at
that
time.

A
few
commenters
raised
a
question
regarding
a
conflict
between
EPA's
existing
policies
and
the
SDWA
principles
and
asked
us
to
identify
the
conflicting
specific
risk
assessment
standards
and
make
every
effort
to
reconcile
the
conflicting
standards
with
the
SDWA
principles.
A
few
commenters
stated
that
EPA
should
not
have
two
separate
standards
for
risk
assessments
(
i.
e.,
one
for
influential
and
one
for
non­
influential),
but
that
all
risk
assessments
should
be
considered
influential.
Another
stated
that
if
there
is
a
conflict
between
existing
policies
and
the
SDWA
principles,
EPA
should
identify
the
conflicting
specific
risk
assessment
standards
and
make
every
effort
to
reconcile
the
conflicting
standards
with
the
SDWA
principles.
Some
commenters
have
questioned
why
the
"
best
available,
peer
reviewed
science
and
supporting
studies"
language
of
SDWA
was
conditioned
by
terms
such
as
"
to
the
extent
practicable"
or
"
as
appropriate."

Adaptation
of
SDWA
Quality
Principles
Public
comments
received
by
the
Agency
on
the
draft
Guidelines
were
widely
divergent.
As
no
obvious
consensus
could
be
drawn,
we
carefully
considered
comments
and
arguments
on
adoption
and
adaptation.
We
also
reviewed
our
experience
with
the
SDWA
principles,
existing
policies,
and
the
applicability
and
appropriateness
of
the
SDWA
language
with
regard
to
the
variety
of
risk
assessments
that
we
conduct
and
have
determined
that,
to
best
meet
the
statutory
obligations
of
the
many
statutes
EPA
implements,
it
remains
most
appropriate
to
adapt
the
SDWA
principles
to
human
health,
safety,
and
environmental
risk
assessments.

In
response
to
public
comments
we
have
removed
"
as
appropriate"
from
these
Guidelines
in
our
SDWA
adaptation.
EPA
agrees
that
the
phrase
peer
reviewed
science
"
as
appropriate"
was
unclear.
We
revised
this
statement
in
part
(
A)
to
"
including,
when
available,
peer­
reviewed
science
and
supporting
studies."
EPA
introduced
such
adaptations
in
order
to
accommodate
the
range
of
real­
world
situations
we
address
in
the
implementation
of
our
diverse
programs.

Numerous
commenters
expressed
that
EPA
did
not
provide
adequate
clarifications
of
how
we
adapted
the
principles
and
what
our
thinking
was
on
each
adaptation.
In
these
Guidelines
we
have
provided
detailed
clarifications
regarding
each
adaptation
made
to
the
original
SDWA
language
and
other
remarks
regarding
our
intent
during
the
implementation
of
the
SDWA
adaptation
for
influential
disseminations
by
EPA.
We
direct
reader
to
the
Guidelines
text
for
such
clarifications.

A.
3.7
Complaint
Resolution
A
few
commenters
noted
that
EPA
should
outline
how
an
affected
person
would
rebut
the
presumption
of
objectivity
afforded
by
peer
review.
EPA
believes
this
determination
would
be
made
on
a
case­
by­
case
basis
considering
the
circumstances
of
a
particular
peer
review
and
has
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Appendix
54
decided
not
to
provide
specific
suggestions
for
affected
persons
on
how
to
rebut
the
presumption
of
objectivity
afforded
by
a
peer
review.

OMB
and
other
commenters
noted
that
agencies'
guidelines
needed
to
make
clear
that
a
request
for
correction
can
be
filed
if
an
affected
person
believes
that
information
does
not
comply
with
the
EPA
Guidelines
and
the
OMB
guidelines.
EPA
has
added
language
in
the
EPA
Guidelines
to
make
sure
this
is
more
clear
to
readers.

EPA
received
numerous
comments
on
the
EPA
definition
of
affected
persons.
In
the
draft
Guidelines,
EPA
had
adopted
OMB's
definition.
EPA
agrees
with
comments
suggesting
that,
instead
of
elaborating
on
the
definition
of
"
affected
person,"
a
more
open
approach
would
be
to
ask
complainants
to
describe
how
they
are
an
affected
person
with
respect
to
the
information
that
is
the
subject
of
their
complaint.
EPA
is
asking
that
persons
submitting
requests
for
correction
provide,
among
other
things,
such
an
explanation.
EPA
has
revised
the
Guidelines
accordingly,
so
that
we
may
consider
this
information
along
with
other
information
in
the
complaint
in
deciding
on
how
to
respond.

Some
commenters
noted
that
the
EPA
Guidelines
do
not
state
how
the
process
will
work,
specifically,
for
States,
municipalities,
and
EPA.
They
expressed
concern
of
being
"
caught
in
the
middle,"
so
to
speak,
on
trying
to
get
their
own
information
corrected.
EPA
does
not
believe
that
the
Guidelines
needed
greater
details
on
how
States
will
work
with
EPA
to
address
complaints,
but
intends
to
work
closely
with
States
to
better
ensure
timely
correction.
EPA
does
appreciate
the
frustration
of
an
information
owner
in
seeing
what
they
deem
"
incorrect"
information
in
a
disseminated
document
or
web
site.
However,
EPA
notes
that
this
is
a
very
complex
issue
that
cannot
be
addressed
with
general
language
in
the
Guidelines
for
all
cases.

Several
comments
indicated
that
EPA
appears
to
have
given
itself
"
carte
blanche"
authority
to
"
elect
not
to
correct"
information.
The
commenters
stated
that
there
was
no
valid
reason
why
EPA
would
opt
out
of
correcting
information
and
that
all
errors
should
be
corrected.
To
the
contrary,
EPA
like
every
Federal
agency
wants
to
correct
wrong
information.
The
issue
is
not
as
simple
as
the
correction
of
an
improper
zip
code
or
phone
number
on
the
EPA
web
site.
Even
these
simple
errors
may
be
very
complex
if
it
would
involve
changing
data
in
an
EPA
and/
or
State
database.
Furthermore,
EPA
is
not
certain
of
the
volume
of
complaints
it
will
receive
after
October
1
and
therefore
needed
to
provide
a
general
provision
in
the
Guidelines
to
recognize
that
once
EPA
approves
a
request,
the
corrective
action
may
vary
depending
on
the
circumstances.
On
a
case­
by­
case
basis,
EPA
will
determine
the
appropriate
corrective
action
for
each
complaint.
EPA
determined
that
this
was
the
most
reasonable
approach.
The
revision
also
recognizes
practical
limitations
on
corrective
action
for
information
from
outside
sources.

Several
commenters
noted
that
EPA
needs
to
establish
time
frames
for
the
complaint
process.
Commenters
stated
that
EPA
should
establish
time
frames
for
when
affected
persons
can
submit
a
complaint
on
an
information
product,
when
EPA
needs
to
responds
to
affected
persons
with
a
decision
on
discrete,
factual
errors,
when
EPA
would
respond
to
affected
persons
with
a
decision
on
more
complex
or
broader
interpretive
issues,
and
when
an
affected
person
should
submit
a
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Appendix
55
request
for
reconsideration.
One
commenter
suggested
that
EPA
solicit
all
complaints
at
one
time
during
a
6­
month
window
or
another
time
frame.
EPA
notes
that
commenters
provided
helpful
examples
and
well
thought
out
proposals
for
such
a
suite
of
time
frames
and
appreciates
the
public
input.

EPA
did
not
agree
on
the
need
to
develop
two
separate
time
frames
for
complaints
that
are
more
factual
in
nature
versus
those
that
are
more
complex.
One
commenter
suggests
a
15­
day
time
line
for
discrete
factual
errors
and
a
45­
day
time
line
for
all
other
complaints.
Another
commenter
recommended
30
days
for
factual
errors
and
60
days
for
all
other
complaints.
Another
commenter
advised
EPA
to
model
this
complaint
process
according
to
the
FOIA
process.
This
commenter
also
suggested
a
3­
week
time
line
for
more
numeric
corrections
and
60
days
for
"
broader
interpretive
issues
or
technical
questions."
While
EPA
appreciates
the
value
of
these
approaches,
they
might
be
problematic
to
implement.
However,
as
EPA
learns
more
about
the
nature
of
this
complaint
process
following
some
period
of
implementation,
these
suggested
approaches
could
be
revisited.

EPA
also
agreed
with
commenters
that
a
window
of
opportunity
for
commenters
to
submit
a
request
for
reconsideration
made
sense.
EPA
has
advised
affected
persons
in
these
Guidelines
to
submit
a
request
for
reconsideration
within
90­
days
of
the
initial
complaint
decision
by
EPA.

Some
commenters
asked
that
EPA
establish
time
lines
for
when
EPA
would
take
corrective
action.
EPA
does
not
anticipate
that
there
would
be
any
value
in
applying
a
specific
time
frame
for
this
action
and
prefers
to
look
at
each
complaint
and
appropriate
corrective
action
on
a
case­
by­
case
basis,
as
discussed
above.

Commenters
suggested
that
45
days
was
a
reasonable
time
frame
for
EPA
to
get
back
to
the
affected
person
with
either
a
decision
or
a
notice
that
EPA
needs
more
time.
One
group
noted
that
HHS,
SSA,
and
NRC
adopted
the
45­
day
window.
EPA
disagreed
with
this
approach
and
instead
opted
for
a
90­
day
time
frame
similar
to
the
DOT
Guidelines.

EPA
received
many
comments
on
how
EPA
should
structure
its
internal
processes
for
the
complaint
resolution
process.
Several
comments
specifically
discussed
the
role
that
OEI
should
play
in
the
initial
complaint
and
the
requests
for
reconsideration.
EPA
does
not
agree
that
OEI
should
be
the
arbiter
on
all
requests
for
reconsideration,
but
does
view
the
role
of
OEI
in
the
process
as
an
important
one.
Namely,
OEI
may
work
to
help
ensure
consistent
responses
to
complaints
and
requests
for
reconsideration.
Other
comments
recommending
specific
internal
implementation
processes
are
being
considered
as
EPA
designs
the
correction
and
request
for
reconsideration
administrative
processes
in
greater
detail.

Many
commenters
argued
that
Assistant
Administrators
and
Regional
Administrators
should
not
decide
requests
for
reconsideration
because
they
would
be
biased
or
would
have
a
conflict
of
interest
when
deciding
complaints
regarding
information
disseminated
by
their
own
Offices
or
programs,
or
if
they
had
to
reconsider
decisions
made
by
their
own
staffs.
EPA
does
not
agree.
This
type
of
decision
making
is
within
the
delegated
decision
making
authority
of
EPA's
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Appendix
56
officials,
and
these
decisions
should
be
presumed
to
be
unbiased
absent
a
specific
showing
that
a
decision
maker
is
not
impartial
in
a
particular
case.
EPA
does
agree
with
commenters
who
noted
that
it
is
important
to
make
consistent
decisions
on
cross­
cutting
information
quality
issues.
In
order
to
achieve
appropriate
consistency
of
response
to
affected
persons
on
requests
for
reconsideration
and
to
ensure
that
cross­
cutting
information
quality
issues
are
considered
across
the
Agency
at
a
senior
level,
EPA
intends
for
an
executive
panel
to
make
the
final
decisions
on
all
requests
for
reconsideration.
Furthermore,
we
felt
it
important
to
add
greater
detail
on
the
time
frame
within
which
EPA
would
respond
to
a
requestor
on
their
request
for
reconsideration.
We
have
added
that
it
is
EPA's
goal
to
respond
to
requesters
regarding
requests
for
reconsideration
within
90
days.

EPA
received
many
recommendations
in
public
comments
to
include
the
public
in
the
EPA
complaint
process.
Specifically,
commenters
requested
that
EPA
notify
the
public
about
all
pending
requests
to
modify
information
and
one
commenter
stated
that
EPA
should
allow
the
public
to
comment
on
information
corrections
requests
for
information
that
are
considered
"
central
to
a
rulemaking
or
other
Final
Agency
Action"
before
EPA
accepts
or
rejects
the
request.
As
a
general
matter,
EPA
does
not
intend
to
solicit
public
comment
on
how
EPA
should
respond
to
requests
for
correction
or
reconsideration.
EPA
also
does
not
intend
to
post
requests
for
correction
and
requests
for
reconsideration
on
the
EPA
web
site,
but
we
plan
to
revisit
this
and
many
other
aspects
of
the
Guidelines
within
one
year
of
implementation.

EPA
also
received
many
comments
on
how
information
that
is
currently
being
reviewed
by
EPA
in
response
to
a
complaint
appears
to
the
public
on
the
EPA
web
site
or
some
other
medium.
Some
commenters
recommended
the
use
of
flags
for
all
information
that
has
a
complaint
pending
with
a
note
that
where
appropriate,
challenged
information
will
be
pulled
from
dissemination
and
removed
from
EPA's
web
site.
Other
commenters
stated
that
the
information
in
question
should
be
removed
from
public
access
until
the
resolution
process
has
been
completed.
Still
other
commenters
requested
that
EPA
not
embark
on
self­
censorship.
As
a
general
rule,
EPA
has
decided
not
to
flag
information
that
has
a
complaint
pending.
EPA
believes
that
information
that
is
the
subject
of
a
pending
complaint
should
not
necessarily
be
removed
from
public
access
based
solely
on
the
receipt
of
a
request
for
correction.

A.
4
Next
Steps
EPA
is
actively
developing
new
policies
and
procedures,
as
appropriate,
to
improve
the
quality
of
information
disseminated
to
the
public.
Some
activities
specifically
support
ensuring
and
maximizing
the
quality,
objectivity,
utility,
and
integrity
of
information.
For
instance,
we
are
consulting
with
the
scientific
community
on
the
subject
of
reproducibility.
The
EPA
Science
Advisory
Board
(
SAB)
is
performing
an
expedited
consultation
on
the
subject
on
October
1,
2002.
Based
on
this
initial
consultation,
EPA
and
the
SAB
may
consider
a
full
review
of
reproducibility
and
related
information
quality
concepts
in
2003.
Furthermore,
as
noted
earlier,
the
EPA
Science
Policy
Council
has
commissioned
a
workgroup
to
develop
assessment
factors
for
consideration
in
assessing
information
that
EPA
collects
or
is
voluntarily
submitted
in
support
of
various
Agency
decisions.
Guidelines
for
Ensuring
and
Maximizing
the
Quality,
Objectivity,
Utility,
and
Integrity
of
Information
Disseminated
by
EPA
Appendix
57
As
new
processes,
policies,
and
procedures
are
considered
and
adopted
into
Agency
operations,
we
will
consider
their
relationship
to
the
Guidelines
and
determine
the
extent
to
which
the
Guidelines
may
need
to
change
to
accommodate
new
activity.