Document ID: EPA-HQ-OAR-2004-0067-0093
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2005-04-07T04:00Z

Federal
Register:
58
FR
51735
Executive
Order
12866
of
September
30,
1993
Regulatory
Planning
and
Review
The
American
people
deserve
a
regulatory
system
that
works
for
them,
not
against
them:
a
regulatory
system
that
protects
and
improves
their
health,
safety,
environment,
and
well­
being
and
improves
the
performance
of
the
economy
without
imposing
unacceptable
or
unreasonable
costs
on
society;
regulatory
policies
that
recognize
that
the
private
sector
and
private
markets
are
the
best
engine
for
economic
growth;
regulatory
approaches
that
respect
the
role
of
State,
local,
and
tribal
governments;
and
regulations
that
are
effective,
consistent,
sensible,
and
understandable.
We
do
not
have
such
a
regulatory
system
today.
With
this
Executive
order,
the
Federal
Government
begins
a
program
to
reform
and
make
more
efficient
the
regulatory
process.
The
objectives
of
this
Executive
order
are
to
enhance
planning
and
coordination
with
respect
to
both
new
and
existing
regulations;
to
reaffirm
the
primacy
of
Federal
agencies
in
the
regulatory
decision­
making
process;
to
restore
the
integrity
and
legitimacy
of
regulatory
review
and
oversight;
and
to
make
the
process
more
accessible
and
open
to
the
public.
In
pursuing
these
objectives,
the
regulatory
process
shall
be
conducted
so
as
to
meet
applicable
statutory
requirements
and
with
due
regard
to
the
discretion
that
has
been
entrusted
to
the
Federal
agencies.
Accordingly,
by
the
authority
vested
in
me
as
President
by
the
Constitution
and
the
laws
of
the
United
States
of
America,
it
is
hereby
ordered
as
follows:

Section
1.
Statement
of
Regulatory
Philosophy
and
Principles.

(
a)
The
Regulatory
Philosophy.
Federal
agencies
should
promulgate
only
such
regulations
as
are
required
by
law,
are
necessary
to
interpret
the
law,
or
are
made
necessary
by
compelling
public
need,
such
as
material
failures
of
private
markets
to
protect
or
improve
the
health
and
safety
of
the
public,
the
environment,
or
the
well­
being
of
the
American
people.
In
deciding
whether
and
how
to
regulate,
agencies
should
assess
all
costs
and
benefits
of
available
regulatory
alternatives,
including
the
alternative
of
not
regulating.
Costs
and
benefits
shall
be
understood
to
include
both
quantifiable
measures
(
to
the
fullest
extent
that
these
can
be
usefully
estimated)
and
qualitative
measures
of
costs
and
benefits
that
are
difficult
to
quantify,
but
nevertheless
essential
to
consider.
Further,
in
choosing
among
alternative
regulatory
approaches,
agencies
should
select
those
approaches
that
maximize
net
benefits
(
including
potential
economic,
environmental,
public
health
and
safety,
and
other
advantages;
distributive
impacts;
and
equity),
unless
a
statute
requires
another
regulatory
approach.

(
b)
The
Principles
of
Regulation.
To
ensure
that
the
agencies'
regulatory
programs
are
consistent
with
the
philosophy
set
forth
above,
agencies
should
adhere
to
the
following
principles,
to
the
extent
permitted
by
law
and
where
applicable:

(
1)
Each
agency
shall
identify
the
problem
that
it
intends
to
address
(
including,
where
applicable,
the
failures
of
private
markets
or
public
institutions
that
warrant
new
agency
action)
as
well
as
assess
the
significance
of
that
problem.

(
2)
Each
agency
shall
examine
whether
existing
regulations
(
or
other
law)
have
created,
or
contributed
to,
the
problem
that
a
new
regulation
is
intended
to
correct
and
whether
those
regulations
(
or
other
law)
should
be
modified
to
achieve
the
intended
goal
of
regulation
more
effectively.

(
3)
Each
agency
shall
identify
and
assess
available
alternatives
to
direct
regulation,
including
providing
economic
incentives
to
encourage
the
desired
behavior,
such
as
user
fees
or
marketable
permits,
or
providing
information
upon
which
choices
can
be
made
by
the
public.

(
4)
In
setting
regulatory
priorities,
each
agency
shall
consider,
to
the
extent
reasonable,
the
degree
and
nature
of
the
risks
posed
by
various
substances
or
activities
within
its
jurisdiction.

(
5)
When
an
agency
determines
that
a
regulation
is
the
best
available
method
of
achieving
the
regulatory
objective,
it
shall
design
its
regulations
in
the
most
cost­
effective
manner
to
achieve
the
regulatory
objective.
In
doing
so,
each
agency
shall
consider
incentives
for
innovation,
consistency,
predictability,
the
costs
of
enforcement
and
compliance
(
to
the
government,
regulated
entities,
and
the
public),
flexibility,
distributive
impacts,
and
equity.

(
6)
Each
agency
shall
assess
both
the
costs
and
the
benefits
of
the
intended
regulation
and,
recognizing
that
some
costs
and
benefits
are
difficult
to
quantify,
propose
or
adopt
a
regulation
only
upon
a
reasoned
determination
that
the
benefits
of
the
intended
regulation
justify
its
costs.

(
7)
Each
agency
shall
base
its
decisions
on
the
best
reasonably
obtainable
scientific,
technical,
economic,
and
other
information
concerning
the
need
for,
and
consequences
of,
the
intended
regulation.

(
8)
Each
agency
shall
identify
and
assess
alternative
forms
of
regulation
and
shall,
to
the
extent
feasible,
specify
performance
objectives,
rather
than
specifying
the
behavior
or
manner
of
compliance
that
regulated
entities
must
adopt.

(
9)
Wherever
feasible,
agencies
shall
seek
views
of
appropriate
State,
local,
and
tribal
officials
before
imposing
regulatory
requirements
that
might
significantly
or
uniquely
affect
those
governmental
entities.
Each
agency
shall
assess
the
effects
of
Federal
regulations
on
State,
local,
and
tribal
governments,
including
specifically
the
availability
of
resources
to
carry
out
those
mandates,
and
seek
to
minimize
those
burdens
that
uniquely
or
significantly
affect
such
governmental
entities,
consistent
with
achieving
regulatory
objectives.
In
addition,
as
appropriate,
agencies
shall
seek
to
harmonize
Federal
regulatory
actions
with
related
State,
local,
and
tribal
regulatory
and
other
governmental
functions.

(
10)
Each
agency
shall
avoid
regulations
that
are
inconsistent,
incompatible,
or
duplicative
with
its
other
regulations
or
those
of
other
Federal
agencies.

(
11)
Each
agency
shall
tailor
its
regulations
to
impose
the
least
burden
on
society,
including
individuals,
businesses
of
differing
sizes,
and
other
entities
(
including
small
communities
and
governmental
entities),
consistent
with
obtaining
the
regulatory
objectives,
taking
into
account,
among
other
things,
and
to
the
extent
practicable,
the
costs
of
cumulative
regulations.

(
12)
Each
agency
shall
draft
its
regulations
to
be
simple
and
easy
to
understand,
with
the
goal
of
minimizing
the
potential
for
uncertainty
and
litigation
arising
from
such
uncertainty.

Sec.
2.
Organization.
An
efficient
regulatory
planning
and
review
process
is
vital
to
ensure
that
the
Federal
Government's
regulatory
system
best
serves
the
American
people.

(
a)
The
Agencies.
Because
Federal
agencies
are
the
repositories
of
significant
substantive
expertise
and
experience,
they
are
responsible
for
developing
regulations
and
assuring
that
the
regulations
are
consistent
with
applicable
law,
the
President's
priorities,
and
the
principles
set
forth
in
this
Executive
order.

(
b)
The
Office
of
Management
and
Budget.
Coordinated
review
of
agency
rulemaking
is
necessary
to
ensure
that
regulations
are
consistent
with
applicable
law,
the
President's
priorities,
and
the
principles
set
forth
in
this
Executive
order,
and
that
decisions
made
by
one
agency
do
not
conflict
with
the
policies
or
actions
taken
or
planned
by
another
agency.
The
Office
of
Management
and
Budget
(
OMB)
shall
carry
out
that
review
function.
Within
OMB,
the
Office
of
Information
and
Regulatory
Affairs
(
OIRA)
is
the
repository
of
expertise
concerning
regulatory
issues,
including
methodologies
and
procedures
that
affect
more
than
one
agency,
this
Executive
order,
and
the
President's
regulatory
policies.
To
the
extent
permitted
by
law,
OMB
shall
provide
guidance
to
agencies
and
assist
the
President,
the
Vice
President,
and
other
regulatory
policy
advisors
to
the
President
in
regulatory
planning
and
shall
be
the
entity
that
reviews
individual
regulations,
as
provided
by
this
Executive
order.

(
c)
The
Vice
President.
The
Vice
President
is
the
principal
advisor
to
the
President
on,
and
shall
coordinate
the
development
and
presentation
of
recommendations
concerning,
regulatory
policy,
planning,
and
review,
as
set
forth
in
this
Executive
order.
In
fulfilling
their
responsibilities
under
this
Executive
order,
the
President
and
the
Vice
President
shall
be
assisted
by
the
regulatory
policy
advisors
within
the
Executive
Office
of
the
President
and
by
such
agency
officials
and
personnel
as
the
President
and
the
Vice
President
may,
from
time
to
time,
consult.

Sec.
3.
Definitions.
For
purposes
of
this
Executive
order:

(
a)
  
Advisors''
refers
to
such
regulatory
policy
advisors
to
the
President
as
the
President
and
Vice
President
may
from
time
to
time
consult,
including,
among
others:
(
1)
the
Director
of
OMB;
(
2)
the
Chair
(
or
another
member)
of
the
Council
of
Economic
Advisers;
(
3)
the
Assistant
to
the
President
for
Economic
Policy;
(
4)
the
Assistant
to
the
President
for
Domestic
Policy;
(
5)
the
Assistant
to
the
President
for
National
Security
Affairs;
(
6)
the
Assistant
to
the
President
for
Science
and
Technology;
(
7)
the
Assistant
to
the
President
for
Intergovernmental
Affairs;
(
8)
the
Assistant
to
the
President
and
Staff
Secretary;
(
9)
the
Assistant
to
the
President
and
Chief
of
Staff
to
the
Vice
President;
(
10)
the
Assistant
to
the
President
and
Counsel
to
the
President;
(
11)
the
Deputy
Assistant
to
the
President
and
Director
of
the
White
House
Office
on
Environmental
Policy;
and
(
12)
the
Administrator
of
OIRA,
who
also
shall
coordinate
communications
relating
to
this
Executive
order
among
the
agencies,
OMB,
the
other
Advisors,
and
the
Office
of
the
Vice
President.

(
b)
  
Agency,''
unless
otherwise
indicated,
means
any
authority
of
the
United
States
that
is
an
  
agency''
under
44
U.
S.
C.
3502(
1),
other
than
those
considered
to
be
independent
regulatory
agencies,
as
defined
in
44
U.
S.
C.
3502(
10).

(
c)
  
Director''
means
the
Director
of
OMB.

(
d)
  
Regulation''
or
  
rule''
means
an
agency
statement
of
general
applicability
and
future
effect,
which
the
agency
intends
to
have
the
force
and
effect
of
law,
that
is
designed
to
implement,
interpret,
or
prescribe
law
or
policy
or
to
describe
the
procedure
or
practice
requirements
of
an
agency.
It
does
not,
however,
include:

(
1)
Regulations
or
rules
issued
in
accordance
with
the
formal
rulemaking
provisions
of
5
U.
S.
C.
556,
557;

(
2)
Regulations
or
rules
that
pertain
to
a
military
or
foreign
affairs
function
of
the
United
States,
other
than
procurement
regulations
and
regulations
involving
the
import
or
export
of
nondefense
articles
and
services;

(
3)
Regulations
or
rules
that
are
limited
to
agency
organization,
management,
or
personnel
matters;
or
(
4)
Any
other
category
of
regulations
exempted
by
the
Administrator
of
OIRA.

(
e)
  
Regulatory
action''
means
any
substantive
action
by
an
agency
(
normally
published
in
the
Federal
Register)
that
promulgates
or
is
expected
to
lead
to
the
promulgation
of
a
final
rule
or
regulation,
including
notices
of
inquiry,
advance
notices
of
proposed
rulemaking,
and
notices
of
proposed
rulemaking.

(
f)
  
Significant
regulatory
action''
means
any
regulatory
action
that
is
likely
to
result
in
a
rule
that
may:

(
1)
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,
local,
or
tribal
governments
or
communities;

(
2)
Create
a
serious
inconsistency
or
otherwise
interfere
with
an
action
taken
or
planned
by
another
agency;

(
3)
Materially
alter
the
budgetary
impact
of
entitlements,
grants,
user
fees,
or
loan
programs
or
the
rights
and
obligations
of
recipients
thereof;
or
(
4)
Raise
novel
legal
or
policy
issues
arising
out
of
legal
mandates,
the
President's
priorities,
or
the
principles
set
forth
in
this
Executive
order.

Sec.
4.
Planning
Mechanism.

In
order
to
have
an
effective
regulatory
program,
to
provide
for
coordination
of
regulations,
to
maximize
consultation
and
the
resolution
of
potential
conflicts
at
an
early
stage,
to
involve
the
public
and
its
State,
local,
and
tribal
officials
in
regulatory
planning,
and
to
ensure
that
new
or
revised
regulations
promote
the
President's
priorities
and
the
principles
set
forth
in
this
Executive
order,
these
procedures
shall
be
followed,
to
the
extent
permitted
by
law:

(
a)
Agencies'
Policy
Meeting.
Early
in
each
year's
planning
cycle,
the
Vice
President
shall
convene
a
meeting
of
the
Advisors
and
the
heads
of
agencies
to
seek
a
common
understanding
of
priorities
and
to
coordinate
regulatory
efforts
to
be
accomplished
in
the
upcoming
year.

(
b)
Unified
Regulatory
Agenda.
For
purposes
of
this
subsection,
the
term
  
agency''
or
  
agencies''
shall
also
include
those
considered
to
be
independent
regulatory
agencies,
as
defined
in
44
U.
S.
C.
3502(
10).
Each
agency
shall
prepare
an
agenda
of
all
regulations
under
development
or
review,
at
a
time
and
in
a
manner
specified
by
the
Administrator
of
OIRA.
The
description
of
each
regulatory
action
shall
contain,
at
a
minimum,
a
regulation
identifier
number,
a
brief
summary
of
the
action,
the
legal
authority
for
the
action,
any
legal
deadline
for
the
action,
and
the
name
and
telephone
number
of
a
knowledgeable
agency
official.
Agencies
may
incorporate
the
information
required
under
5
U.
S.
C.
602
and
41
U.
S.
C.
402
into
these
agendas.

(
c)
The
Regulatory
Plan.
For
purposes
of
this
subsection,
the
term
  
agency''
or
  
agencies''
shall
also
include
those
considered
to
be
independent
regulatory
agencies,
as
defined
in
44
U.
S.
C.
3502(
10).
(
1)
As
part
of
the
Unified
Regulatory
Agenda,
beginning
in
1994,
each
agency
shall
prepare
a
Regulatory
Plan
(
Plan)
of
the
most
important
significant
regulatory
actions
that
the
agency
reasonably
expects
to
issue
in
proposed
or
final
form
in
that
fiscal
year
or
thereafter.
The
Plan
shall
be
approved
personally
by
the
agency
head
and
shall
contain
at
a
minimum:

(
A)
A
statement
of
the
agency's
regulatory
objectives
and
priorities
and
how
they
relate
to
the
President's
priorities;

(
B)
A
summary
of
each
planned
significant
regulatory
action
including,
to
the
extent
possible,
alternatives
to
be
considered
and
preliminary
estimates
of
the
anticipated
costs
and
benefits;

(
C)
A
summary
of
the
legal
basis
for
each
such
action,
including
whether
any
aspect
of
the
action
is
required
by
statute
or
court
order;

(
D)
A
statement
of
the
need
for
each
such
action
and,
if
applicable,
how
the
action
will
reduce
risks
to
public
health,
safety,
or
the
environment,
as
well
as
how
the
magnitude
of
the
risk
addressed
by
the
action
relates
to
other
risks
within
the
jurisdiction
of
the
agency;

(
E)
The
agency's
schedule
for
action,
including
a
statement
of
any
applicable
statutory
or
judicial
deadlines;
and
(
F)
The
name,
address,
and
telephone
number
of
a
person
the
public
may
contact
for
additional
information
about
the
planned
regulatory
action.

(
2)
Each
agency
shall
forward
its
Plan
to
OIRA
by
June
1st
of
each
year.

(
3)
Within
10
calendar
days
after
OIRA
has
received
an
agency's
Plan,
OIRA
shall
circulate
it
to
other
affected
agencies,
the
Advisors,
and
the
Vice
President.

(
4)
An
agency
head
who
believes
that
a
planned
regulatory
action
of
another
agency
may
conflict
with
its
own
policy
or
action
taken
or
planned
shall
promptly
notify,
in
writing,
the
Administrator
of
OIRA,
who
shall
forward
that
communication
to
the
issuing
agency,
the
Advisors,
and
the
Vice
President.

(
5)
If
the
Administrator
of
OIRA
believes
that
a
planned
regulatory
action
of
an
agency
may
be
inconsistent
with
the
President's
priorities
or
the
principles
set
forth
in
this
Executive
order
or
may
be
in
conflict
with
any
policy
or
action
taken
or
planned
by
another
agency,
the
Administrator
of
OIRA
shall
promptly
notify,
in
writing,
the
affected
agencies,
the
Advisors,
and
the
Vice
President.

(
6)
The
Vice
President,
with
the
Advisors'
assistance,
may
consult
with
the
heads
of
agencies
with
respect
to
their
Plans
and,
in
appropriate
instances,
request
further
consideration
or
inter­
agency
coordination.
(
7)
The
Plans
developed
by
the
issuing
agency
shall
be
published
annually
in
the
October
publication
of
the
Unified
Regulatory
Agenda.
This
publication
shall
be
made
available
to
the
Congress;
State,
local,
and
tribal
governments;
and
the
public.
Any
views
on
any
aspect
of
any
agency
Plan,
including
whether
any
planned
regulatory
action
might
conflict
with
any
other
planned
or
existing
regulation,
impose
any
unintended
consequences
on
the
public,
or
confer
any
unclaimed
benefits
on
the
public,
should
be
directed
to
the
issuing
agency,
with
a
copy
to
OIRA.

(
d)
Regulatory
Working
Group.
Within
30
days
of
the
date
of
this
Executive
order,
the
Administrator
of
OIRA
shall
convene
a
Regulatory
Working
Group
(  
Working
Group''),
which
shall
consist
of
representatives
of
the
heads
of
each
agency
that
the
Administrator
determines
to
have
significant
domestic
regulatory
responsibility,
the
Advisors,
and
the
Vice
President.
The
Administrator
of
OIRA
shall
chair
the
Working
Group
and
shall
periodically
advise
the
Vice
President
on
the
activities
of
the
Working
Group.
The
Working
Group
shall
serve
as
a
forum
to
assist
agencies
in
identifying
and
analyzing
important
regulatory
issues
(
including,
among
others
(
1)
the
development
of
innovative
regulatory
techniques,
(
2)
the
methods,
efficacy,
and
utility
of
comparative
risk
assessment
in
regulatory
decision­
making,
and
(
3)
the
development
of
short
forms
and
other
streamlined
regulatory
approaches
for
small
businesses
and
other
entities).
The
Working
Group
shall
meet
at
least
quarterly
and
may
meet
as
a
whole
or
in
subgroups
of
agencies
with
an
interest
in
particular
issues
or
subject
areas.
To
inform
its
discussions,
the
Working
Group
may
commission
analytical
studies
and
reports
by
OIRA,
the
Administrative
Conference
of
the
United
States,
or
any
other
agency.

(
e)
Conferences.
The
Administrator
of
OIRA
shall
meet
quarterly
with
representatives
of
State,
local,
and
tribal
governments
to
identify
both
existing
and
proposed
regulations
that
may
uniquely
or
significantly
affect
those
governmental
entities.
The
Administrator
of
OIRA
shall
also
convene,
from
time
to
time,
conferences
with
representatives
of
businesses,
nongovernmental
organizations,
and
the
public
to
discuss
regulatory
issues
of
common
concern.

Sec.
5.
Existing
Regulations.

In
order
to
reduce
the
regulatory
burden
on
the
American
people,
their
families,
their
communities,
their
State,
local,
and
tribal
governments,
and
their
industries;
to
determine
whether
regulations
promulgated
by
the
executive
branch
of
the
Federal
Government
have
become
unjustified
or
unnecessary
as
a
result
of
changed
circumstances;
to
confirm
that
regulations
are
both
compatible
with
each
other
and
not
duplicative
or
inappropriately
burdensome
in
the
aggregate;
to
ensure
that
all
regulations
are
consistent
with
the
President's
priorities
and
the
principles
set
forth
in
this
Executive
order,
within
applicable
law;
and
to
otherwise
improve
the
effectiveness
of
existing
regulations:
(
a)
Within
90
days
of
the
date
of
this
Executive
order,
each
agency
shall
submit
to
OIRA
a
program,
consistent
with
its
resources
and
regulatory
priorities,
under
which
the
agency
will
periodically
review
its
existing
significant
regulations
to
determine
whether
any
such
regulations
should
be
modified
or
eliminated
so
as
to
make
the
agency's
regulatory
program
more
effective
in
achieving
the
regulatory
objectives,
less
burdensome,
or
in
greater
alignment
with
the
President's
priorities
and
the
principles
set
forth
in
this
Executive
order.
Any
significant
regulations
selected
for
review
shall
be
included
in
the
agency's
annual
Plan.
The
agency
shall
also
identify
any
legislative
mandates
that
require
the
agency
to
promulgate
or
continue
to
impose
regulations
that
the
agency
believes
are
unnecessary
or
outdated
by
reason
of
changed
circumstances.

(
b)
The
Administrator
of
OIRA
shall
work
with
the
Regulatory
Working
Group
and
other
interested
entities
to
pursue
the
objectives
of
this
section.
State,
local,
and
tribal
governments
are
specifically
encouraged
to
assist
in
the
identification
of
regulations
that
impose
significant
or
unique
burdens
on
those
governmental
entities
and
that
appear
to
have
outlived
their
justification
or
be
otherwise
inconsistent
with
the
public
interest.

(
c)
The
Vice
President,
in
consultation
with
the
Advisors,
may
identify
for
review
by
the
appropriate
agency
or
agencies
other
existing
regulations
of
an
agency
or
groups
of
regulations
of
more
than
one
agency
that
affect
a
particular
group,
industry,
or
sector
of
the
economy,
or
may
identify
legislative
mandates
that
may
be
appropriate
for
reconsideration
by
the
Congress.

Sec.
6.
Centralized
Review
of
Regulations.

The
guidelines
set
forth
below
shall
apply
to
all
regulatory
actions,
for
both
new
and
existing
regulations,
by
agencies
other
than
those
agencies
specifically
exempted
by
the
Administrator
of
OIRA:

(
a)
Agency
Responsibilities.
(
1)
Each
agency
shall
(
consistent
with
its
own
rules,
regulations,
or
procedures)
provide
the
public
with
meaningful
participation
in
the
regulatory
process.
In
particular,
before
issuing
a
notice
of
proposed
rulemaking,
each
agency
should,
where
appropriate,
seek
the
involvement
of
those
who
are
intended
to
benefit
from
and
those
expected
to
be
burdened
by
any
regulation
(
including,
specifically,
State,
local,
and
tribal
officials).
In
addition,
each
agency
should
afford
the
public
a
meaningful
opportunity
to
comment
on
any
proposed
regulation,
which
in
most
cases
should
include
a
comment
period
of
not
less
than
60
days.
Each
agency
also
is
directed
to
explore
and,
where
appropriate,
use
consensual
mechanisms
for
developing
regulations,
including
negotiated
rulemaking.

(
2)
Within
60
days
of
the
date
of
this
Executive
order,
each
agency
head
shall
designate
a
Regulatory
Policy
Officer
who
shall
report
to
the
agency
head.
The
Regulatory
Policy
Officer
shall
be
involved
at
each
stage
of
the
regulatory
process
to
foster
the
development
of
effective,
innovative,
and
least
burdensome
regulations
and
to
further
the
principles
set
forth
in
this
Executive
order.

(
3)
In
addition
to
adhering
to
its
own
rules
and
procedures
and
to
the
requirements
of
the
Administrative
Procedure
Act
[
5
U.
S.
C.
551
et
seq.,
701
et
seq.],
the
Regulatory
Flexibility
Act
[
5
U.
S.
C.
601
et
seq.],
the
Paperwork
Reduction
Act
[
44
U.
S.
C.
3501
et
seq.],
and
other
applicable
law,
each
agency
shall
develop
its
regulatory
actions
in
a
timely
fashion
and
adhere
to
the
following
procedures
with
respect
to
a
regulatory
action:

(
A)
Each
agency
shall
provide
OIRA,
at
such
times
and
in
the
manner
specified
by
the
Administrator
of
OIRA,
with
a
list
of
its
planned
regulatory
actions,
indicating
those
which
the
agency
believes
are
significant
regulatory
actions
within
the
meaning
of
this
Executive
order.
Absent
a
material
change
in
the
development
of
the
planned
regulatory
action,
those
not
designated
as
significant
will
not
be
subject
to
review
under
this
section
unless,
within
10
working
days
of
receipt
of
the
list,
the
Administrator
of
OIRA
notifies
the
agency
that
OIRA
has
determined
that
a
planned
regulation
is
a
significant
regulatory
action
within
the
meaning
of
this
Executive
order.
The
Administrator
of
OIRA
may
waive
review
of
any
planned
regulatory
action
designated
by
the
agency
as
significant,
in
which
case
the
agency
need
not
further
comply
with
subsection
(
a)(
3)(
B)
or
subsection
(
a)(
3)(
C)
of
this
section.

(
B)
For
each
matter
identified
as,
or
determined
by
the
Administrator
of
OIRA
to
be,
a
significant
regulatory
action,
the
issuing
agency
shall
provide
to
OIRA:

(
i)
The
text
of
the
draft
regulatory
action,
together
with
a
reasonably
detailed
description
of
the
need
for
the
regulatory
action
and
an
explanation
of
how
the
regulatory
action
will
meet
that
need;
and
(
ii)
An
assessment
of
the
potential
costs
and
benefits
of
the
regulatory
action,
including
an
explanation
of
the
manner
in
which
the
regulatory
action
is
consistent
with
a
statutory
mandate
and,
to
the
extent
permitted
by
law,
promotes
the
President's
priorities
and
avoids
undue
interference
with
State,
local,
and
tribal
governments
in
the
exercise
of
their
governmental
functions.

(
C)
For
those
matters
identified
as,
or
determined
by
the
Administrator
of
OIRA
to
be,
a
significant
regulatory
action
within
the
scope
of
section
3(
f)(
1),
the
agency
shall
also
provide
to
OIRA
the
following
additional
information
developed
as
part
of
the
agency's
decision­
making
process
(
unless
prohibited
by
law):

(
i)
An
assessment,
including
the
underlying
analysis,
of
benefits
anticipated
from
the
regulatory
action
(
such
as,
but
not
limited
to,
the
promotion
of
the
efficient
functioning
of
the
economy
and
private
markets,
the
enhancement
of
health
and
safety,
the
protection
of
the
natural
environment,
and
the
elimination
or
reduction
of
discrimination
or
bias)
together
with,
to
the
extent
feasible,
a
quantification
of
those
benefits;

(
ii)
An
assessment,
including
the
underlying
analysis,
of
costs
anticipated
from
the
regulatory
action
(
such
as,
but
not
limited
to,
the
direct
cost
both
to
the
government
in
administering
the
regulation
and
to
businesses
and
others
in
complying
with
the
regulation,
and
any
adverse
effects
on
the
efficient
functioning
of
the
economy,
private
markets
(
including
productivity,
employment,
and
competitiveness),
health,
safety,
and
the
natural
environment),
together
with,
to
the
extent
feasible,
a
quantification
of
those
costs;
and
(
iii)
An
assessment,
including
the
underlying
analysis,
of
costs
and
benefits
of
potentially
effective
and
reasonably
feasible
alternatives
to
the
planned
regulation,
identified
by
the
agencies
or
the
public
(
including
improving
the
current
regulation
and
reasonably
viable
nonregulatory
actions),
and
an
explanation
why
the
planned
regulatory
action
is
preferable
to
the
identified
potential
alternatives.

(
D)
In
emergency
situations
or
when
an
agency
is
obligated
by
law
to
act
more
quickly
than
normal
review
procedures
allow,
the
agency
shall
notify
OIRA
as
soon
as
possible
and,
to
the
extent
practicable,
comply
with
subsections
(
a)(
3)(
B)
and
(
C)
of
this
section.
For
those
regulatory
actions
that
are
governed
by
a
statutory
or
court­
imposed
deadline,
the
agency
shall,
to
the
extent
practicable,
schedule
rulemaking
proceedings
so
as
to
permit
sufficient
time
for
OIRA
to
conduct
its
review,
as
set
forth
below
in
subsection
(
b)(
2)
through
(
4)
of
this
section.

(
E)
After
the
regulatory
action
has
been
published
in
the
Federal
Register
or
otherwise
issued
to
the
public,
the
agency
shall:

(
i)
Make
available
to
the
public
the
information
set
forth
in
subsections
(
a)(
3)(
B)
and
(
C);

(
ii)
Identify
for
the
public,
in
a
complete,
clear,
and
simple
manner,
the
substantive
changes
between
the
draft
submitted
to
OIRA
for
review
and
the
action
subsequently
announced;
and
(
iii)
Identify
for
the
public
those
changes
in
the
regulatory
action
that
were
made
at
the
suggestion
or
recommendation
of
OIRA.

(
F)
All
information
provided
to
the
public
by
the
agency
shall
be
in
plain,
understandable
language.

(
b)
OIRA
Responsibilities.
The
Administrator
of
OIRA
shall
provide
meaningful
guidance
and
oversight
so
that
each
agency's
regulatory
actions
are
consistent
with
applicable
law,
the
President's
priorities,
and
the
principles
set
forth
in
this
Executive
order
and
do
not
conflict
with
the
policies
or
actions
of
another
agency.
OIRA
shall,
to
the
extent
permitted
by
law,
adhere
to
the
following
guidelines:

(
1)
OIRA
may
review
only
actions
identified
by
the
agency
or
by
OIRA
as
significant
regulatory
actions
under
subsection
(
a)(
3)(
A)
of
this
section.

(
2)
OIRA
shall
waive
review
or
notify
the
agency
in
writing
of
the
results
of
its
review
within
the
following
time
periods:

(
A)
For
any
notices
of
inquiry,
advance
notices
of
proposed
rulemaking,
or
other
preliminary
regulatory
actions
prior
to
a
Notice
of
Proposed
Rulemaking,
within
10
working
days
after
the
date
of
submission
of
the
draft
action
to
OIRA;

(
B)
For
all
other
regulatory
actions,
within
90
calendar
days
after
the
date
of
submission
of
the
information
set
forth
in
subsections
(
a)(
3)(
B)
and
(
C)
of
this
section,
unless
OIRA
has
previously
reviewed
this
information
and,
since
that
review,
there
has
been
no
material
change
in
the
facts
and
circumstances
upon
which
the
regulatory
action
is
based,
in
which
case,
OIRA
shall
complete
its
review
within
45
days;
and
(
C)
The
review
process
may
be
extended
(
1)
once
by
no
more
than
30
calendar
days
upon
the
written
approval
of
the
Director
and
(
2)
at
the
request
of
the
agency
head.

(
3)
For
each
regulatory
action
that
the
Administrator
of
OIRA
returns
to
an
agency
for
further
consideration
of
some
or
all
of
its
provisions,
the
Administrator
of
OIRA
shall
provide
the
issuing
agency
a
written
explanation
for
such
return,
setting
forth
the
pertinent
provision
of
this
Executive
order
on
which
OIRA
is
relying.
If
the
agency
head
disagrees
with
some
or
all
of
the
bases
for
the
return,
the
agency
head
shall
so
inform
the
Administrator
of
OIRA
in
writing.

(
4)
Except
as
otherwise
provided
by
law
or
required
by
a
Court,
in
order
to
ensure
greater
openness,
accessibility,
and
accountability
in
the
regulatory
review
process,
OIRA
shall
be
governed
by
the
following
disclosure
requirements:

(
A)
Only
the
Administrator
of
OIRA
(
or
a
particular
designee)
shall
receive
oral
communications
initiated
by
persons
not
employed
by
the
executive
branch
of
the
Federal
Government
regarding
the
substance
of
a
regulatory
action
under
OIRA
review;

(
B)
All
substantive
communications
between
OIRA
personnel
and
persons
not
employed
by
the
executive
branch
of
the
Federal
Government
regarding
a
regulatory
action
under
review
shall
be
governed
by
the
following
guidelines:
(
i)
A
representative
from
the
issuing
agency
shall
be
invited
to
any
meeting
between
OIRA
personnel
and
such
person(
s);

(
ii)
OIRA
shall
forward
to
the
issuing
agency,
within
10
working
days
of
receipt
of
the
communication(
s),
all
written
communications,
regardless
of
format,
between
OIRA
personnel
and
any
person
who
is
not
employed
by
the
executive
branch
of
the
Federal
Government,
and
the
dates
and
names
of
individuals
involved
in
all
substantive
oral
communications
(
including
meetings
to
which
an
agency
representative
was
invited,
but
did
not
attend,
and
telephone
conversations
between
OIRA
personnel
and
any
such
persons);
and
(
iii)
OIRA
shall
publicly
disclose
relevant
information
about
such
communication(
s),
as
set
forth
below
in
subsection
(
b)(
4)(
C)
of
this
section.

(
C)
OIRA
shall
maintain
a
publicly
available
log
that
shall
contain,
at
a
minimum,
the
following
information
pertinent
to
regulatory
actions
under
review:
(
i)
The
status
of
all
regulatory
actions,
including
if
(
and
if
so,
when
and
by
whom)
Vice
Presidential
and
Presidential
consideration
was
requested;

(
ii)
A
notation
of
all
written
communications
forwarded
to
an
issuing
agency
under
subsection
(
b)(
4)(
B)(
ii)
of
this
section;
and
(
iii)
The
dates
and
names
of
individuals
involved
in
all
substantive
oral
communications,
including
meetings
and
telephone
conversations,
between
OIRA
personnel
and
any
person
not
employed
by
the
executive
branch
of
the
Federal
Government,
and
the
subject
matter
discussed
during
such
communications.

(
D)
After
the
regulatory
action
has
been
published
in
the
Federal
Register
or
otherwise
issued
to
the
public,
or
after
the
agency
has
announced
its
decision
not
to
publish
or
issue
the
regulatory
action,
OIRA
shall
make
available
to
the
public
all
documents
exchanged
between
OIRA
and
the
agency
during
the
review
by
OIRA
under
this
section.

(
5)
All
information
provided
to
the
public
by
OIRA
shall
be
in
plain,
understandable
language.

Sec.
7.
Resolution
of
Conflicts.

To
the
extent
permitted
by
law,
disagreements
or
conflicts
between
or
among
agency
heads
or
between
OMB
and
any
agency
that
cannot
be
resolved
by
the
Administrator
of
OIRA
shall
be
resolved
by
the
President,
or
by
the
Vice
President
acting
at
the
request
of
the
President,
with
the
relevant
agency
head
(
and,
as
appropriate,
other
interested
government
officials).
Vice
Presidential
and
Presidential
consideration
of
such
disagreements
may
be
initiated
only
by
the
Director,
by
the
head
of
the
issuing
agency,
or
by
the
head
of
an
agency
that
has
a
significant
interest
in
the
regulatory
action
at
issue.
Such
review
will
not
be
undertaken
at
the
request
of
other
persons,
entities,
or
their
agents.

Resolution
of
such
conflicts
shall
be
informed
by
recommendations
developed
by
the
Vice
President,
after
consultation
with
the
Advisors
(
and
other
executive
branch
officials
or
personnel
whose
responsibilities
to
the
President
include
the
subject
matter
at
issue).
The
development
of
these
recommendations
shall
be
concluded
within
60
days
after
review
has
been
requested.

During
the
Vice
Presidential
and
Presidential
review
period,
communications
with
any
person
not
employed
by
the
Federal
Government
relating
to
the
substance
of
the
regulatory
action
under
review
and
directed
to
the
Advisors
or
their
staffs
or
to
the
staff
of
the
Vice
President
shall
be
in
writing
and
shall
be
forwarded
by
the
recipient
to
the
affected
agency(
ies)
for
inclusion
in
the
public
docket(
s).
When
the
communication
is
not
in
writing,
such
Advisors
or
staff
members
shall
inform
the
outside
party
that
the
matter
is
under
review
and
that
any
comments
should
be
submitted
in
writing.

At
the
end
of
this
review
process,
the
President,
or
the
Vice
President
acting
at
the
request
of
the
President,
shall
notify
the
affected
agency
and
the
Administrator
of
OIRA
of
the
President's
decision
with
respect
to
the
matter.

Sec.
8.
Publication.

Except
to
the
extent
required
by
law,
an
agency
shall
not
publish
in
the
Federal
Register
or
otherwise
issue
to
the
public
any
regulatory
action
that
is
subject
to
review
under
section
6
of
this
Executive
order
until
(
1)
the
Administrator
of
OIRA
notifies
the
agency
that
OIRA
has
waived
its
review
of
the
action
or
has
completed
its
review
without
any
requests
for
further
consideration,
or
(
2)
the
applicable
time
period
in
section
6(
b)(
2)
expires
without
OIRA
having
notified
the
agency
that
it
is
returning
the
regulatory
action
for
further
consideration
under
section
6(
b)(
3),
whichever
occurs
first.
If
the
terms
of
the
preceding
sentence
have
not
been
satisfied
and
an
agency
wants
to
publish
or
otherwise
issue
a
regulatory
action,
the
head
of
that
agency
may
request
Presidential
consideration
through
the
Vice
President,
as
provided
under
section
7
of
this
order.
Upon
receipt
of
this
request,
the
Vice
President
shall
notify
OIRA
and
the
Advisors.
The
guidelines
and
time
period
set
forth
in
section
7
shall
apply
to
the
publication
of
regulatory
actions
for
which
Presidential
consideration
has
been
sought.

Sec.
9.
Agency
Authority.
Nothing
in
this
order
shall
be
construed
as
displacing
the
agencies'
authority
or
responsibilities,
as
authorized
by
law.

Sec.
10.
Judicial
Review.
Nothing
in
this
Executive
order
shall
affect
any
otherwise
available
judicial
review
of
agency
action.
This
Executive
order
is
intended
only
to
improve
the
internal
management
of
the
Federal
Government
and
does
not
create
any
right
or
benefit,
substantive
or
procedural,
enforceable
at
law
or
equity
by
a
party
against
the
United
States,
its
agencies
or
instrumentalities,
its
officers
or
employees,
or
any
other
person.
Sec.
11.
Revocations.
Executive
Orders
Nos.
12291
and
12498;
all
amendments
to
those
Executive
orders;
all
guidelines
issued
under
those
orders;
and
any
exemptions
from
those
orders
heretofore
granted
for
any
category
of
rule
are
revoked.

William
J.
Clinton