Document ID: EPA-HQ-OW-2003-0002-0099
Agency: epa
Document Type: Proposed Rule
Title: OMB Circular A-119: Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities.
Posted Date: 2003-03-12T05:00Z

federalregister
8545
Thursday
February
19,
1998
Part
IV
Executive
Office
of
the
President
Office
of
Management
and
Budget
OMB
Circular
A
 
119;
Federal
Participation
in
the
Development
and
Use
of
Voluntary
Consensus
Standards
and
in
Conformity
Assessment
Activities;
Notice
8546
Federal
Register
/
Vol.
63,
No.
33
/
Thursday,
February
19,
1998
/
Notices
EXECUTIVE
OFFICE
OF
THE
PRESIDENT
Office
of
Management
and
Budget
OMB
Circular
A
 
119;
Federal
Participation
in
the
Development
and
Use
of
Voluntary
Consensus
Standards
and
in
Conformity
Assessment
Activities
AGENCY:
Office
of
Management
and
Budget,
EOP.
ACTION:
Final
Revision
of
Circular
A
 
119.

SUMMARY:
The
Office
of
Management
and
Budget
(
OMB)
has
revised
Circular
A
 
119
on
federal
use
and
development
of
voluntary
standards.
OMB
has
revised
this
Circular
in
order
to
make
the
terminology
of
the
Circular
consistent
with
the
National
Technology
Transfer
and
Advancement
Act
of
1995,
to
issue
guidance
to
the
agencies
on
making
their
reports
to
OMB,
to
direct
the
Secretary
of
Commerce
to
issue
policy
guidance
for
conformity
assessment,
and
to
make
changes
for
clarity.
DATES:
Effective
February
19,
1998.
ADDRESSES:
Direct
any
comments
or
inquiries
to
the
Office
of
Information
and
Regulatory
Affairs,
Office
of
Management
and
Budget,
NEOB
Room
10236,
Washington,
D.
C.
20503.
Available
at
http://
www.
whitehouse.
gov/
WH/
EOP/
omb
or
at
(
202)
395
 
7332.

FOR
FURTHER
INFORMATION
CONTACT:
Virginia
Huth
(
202)
395
 
3785.

SUPPLEMENTARY
INFORMATION:
I.
Existing
OMB
Circular
A
 
119
II.
Authority
III.
Notice
and
Request
for
Comments
on
Proposed
Revision
of
OMB
Circular
119
 
A
IV.
Discussion
of
Significant
Comments
and
Changes
I.
Existing
OMB
Circular
A
 
119
Standards
developed
by
voluntary
consensus
standards
bodies
are
often
appropriate
for
use
in
achieving
federal
policy
objectives
and
in
conducting
federal
activities,
including
procurement
and
regulation.
The
policies
of
OMB
Circular
A
 
119
are
intended
to:
(
1)
Encourage
federal
agencies
to
benefit
from
the
expertise
of
the
private
sector;
(
2)
promote
federal
agency
participation
in
such
bodies
to
ensure
creation
of
standards
that
are
useable
by
federal
agencies;
and
(
3)
reduce
reliance
on
government­
unique
standards
where
an
existing
voluntary
standard
would
suffice.
OMB
Circular
A
 
119
was
last
revised
on
October
20,
1993.
This
revision
stated
that
the
policy
of
the
federal
government,
in
its
procurement
and
regulatory
activities,
is
to:
(
1)
`[
r]
ely
on
voluntary
standards,
both
domestic
and
international,
whenever
feasible
and
consistent
with
law
and
regulation;''
(
2)
``[
p]
articipate
in
voluntary
standards
bodies
when
such
participation
is
in
the
public
interest
and
is
compatible
with
agencies'
missions,
authorities,
priorities,
and
budget
resources;''
and
(
3)
``[
c]
oordinate
agency
participation
in
voluntary
standards
bodies
so
that
*
*
*
the
most
effective
use
is
made
of
agency
resources
*
*
*
and
[
that]
the
views
expressed
by
such
representatives
are
in
the
public
interest
and
*
*
*
do
not
conflict
with
the
interests
and
established
views
of
the
agencies.''
[
See
section
6
entitled
``
Policy'].

II.
Authority
Authority
for
this
Circular
is
based
on
31
U.
S.
C.
1111,
which
gives
OMB
broad
authority
to
establish
policies
for
the
improved
management
of
the
Executive
Branch.
In
February
1996,
Section
12(
d)
of
Public
Law
104
 
113,
the
``
National
Technology
Transfer
and
Advancement
Act
of
1995,''
(
or
``
the
Act'')
was
passed
by
the
Congress
in
order
to
establish
the
policies
of
the
existing
OMB
Circular
A
 
119
in
law.
[
See
142
Cong.
Rec.
H1264
 
1267
(
daily
ed.
February
27,
1996)
(
statement
of
Rep.
Morella);
142
Cong.
Rec.
S1078
 
1082
(
daily
ed.
February
7,
1996)
(
statement
of
Sen.
Rockefeller);
141
Cong.
Rec.
H14333
 
34
(
daily
ed.
December
12,
1995)
(
statements
of
Reps.
Brown
and
Morella)].
The
purposes
of
Section
12(
d)
of
the
Act
are:
(
1)
To
direct
``
federal
agencies
to
focus
upon
increasing
their
use
of
[
voluntary
consensus]
standards
whenever
possible,''
thus,
reducing
federal
procurement
and
operating
costs;
and
(
2)
to
authorize
the
National
Institute
of
Standards
and
Technology
(
NIST)
as
the
``
federal
coordinator
for
government
entities
responsible
for
the
development
of
technical
standards
and
conformity
assessment
activities,''
thus
eliminating
``
unnecessary
duplication
of
conformity
assessment
activities.''
[
See
Cong.
Rec.
H1262
(
daily
ed.
February
27,
1996)
(
statements
of
Rep.
Morella)].
The
Act
gives
the
agencies
discretion
to
use
other
standards
in
lieu
of
voluntary
consensus
standards
where
use
of
the
latter
would
be
``
inconsistent
with
applicable
law
or
otherwise
impractical.''
However,
in
such
cases,
the
head
of
an
agency
or
department
must
send
to
OMB,
through
NIST,
``
an
explanation
of
the
reasons
for
using
such
standards.''
The
Act
states
that
beginning
with
fiscal
year
1997,
OMB
will
transmit
to
Congress
and
its
committees
an
annual
report
summarizing
all
explanations
received
in
the
preceding
year.

III.
Notice
and
Request
for
Comments
on
Proposed
Revision
of
OMB
Circular
A
 
119
On
December
27,
1996,
OMB
published
a
``
Notice
and
Request
for
Comments
on
Proposed
Revision
of
OMB
Circular
A
 
119''
(
61
FR
68312).
The
purpose
of
the
proposed
revision
was
to
provide
policy
guidance
to
the
agencies,
to
provide
instructions
on
the
new
reporting
requirements,
to
conform
the
Circular's
terminology
to
the
Act,
and
to
improve
the
Circular's
clarity
and
effectiveness.
On
February
10,
1997,
OMB
conducted
a
public
meeting
to
receive
comments
and
answer
questions.
In
response
to
the
proposed
revision,
OMB
received
comments
from
over
50
sources,
including
voluntary
consensus
standards
bodies
or
standards
development
organizations
(
SDOs),
industry
organizations,
private
companies,
federal
agencies,
and
individuals.

IV.
Discussion
of
Significant
Comments
and
Changes
Although
some
commentators
were
critical
of
specific
aspects
of
the
proposed
revision,
the
majority
of
commentators
expressed
support
for
the
overall
policies
of
the
Circular
and
the
approaches
taken.
The
more
substantive
comments
are
summarized
below,
along
with
OMB's
response.
The
Circular
has
also
been
converted
into
``
Plain
English''
format.
Specifically,
the
following
changes
were
made.
We
placed
definitions
where
the
term
is
first
used;
replaced
the
term
``
must''
with
``
shall''
where
the
intent
was
to
establish
a
requirement;
created
a
question
and
answer
format
using
``
you''
and
``
I';
and
added
a
Table
of
Contents.
We
replaced
proposed
sections
6,
7
and
10
(``
Policy,''
``
Guidance,''
and
``
Conformity
Assessment'')
with
sections
6,
7,
and
8,
which
reorganized
the
material.
We
reorganized
the
definitions
for
``
standard,''
``
technical
standard,''
and
``
voluntary
consensus
standard.''
We
reorganized
proposed
section
8
on
``
Procedures''
into
sections
9,
10,
11,
12.
For
clarity,
we
have
referenced
provisions
by
their
location
both
in
the
proposed
Circular
and
in
the
final
Circular.

Proposed
Section
1
 
Purpose.
Final
Section
1
1.
Several
commentators
suggested
that
this
section
should
be
modified
to
make
clear
that
the
primary
purpose
of
8547
Federal
Register
/
Vol.
63,
No.
33
/
Thursday,
February
19,
1998
/
Notices
the
revision
of
the
Circular
is
to
interpret
the
provisions
of
section
12(
d)
of
Pub.
L.
104
 
113
so
that
federal
agencies
can
properly
implement
the
statutory
requirements.
We
revised
the
wording
of
this
section
to
reflect
this
suggestion.

Proposed
Section
2
 
Rescissions.
Final
Section
1
2.
We
moved
this
section
to
Final
Section
1.

Proposed
Section
3
 
Background.
Final
Section
2
3.
Several
commentators
suggested
substituting
``
use''
for
``
adoption''
in
this
section
to
conform
to
the
new
set
of
definitions.
We
agree,
and
we
modified
the
final
Circular.

Proposed
Section
4
 
Applicability.
Final
Section
5
4.
Several
commentators
found
this
section
unclear.
One
commentator
suggested
deleting
``
international
standardization
agreements,''
suggesting
this
section
could
be
interpreted
as
conflicting
with
proposed
section
7a(
1)
which
encouraged
consideration
of
international
standards
developed
by
voluntary
consensus
standards.
We
agree,
and
we
modified
the
final
Circular.

Proposed
Section
5a
 
Definition
of
Agency.
Final
Section
5
5.
A
commentator
suggested
defining
the
term
``
agency
mission.''
Upon
consideration,
we
have
decided
that
this
term
is
sufficiently
well
understood
as
to
not
require
further
elaboration;
it
refers
to
the
particular
statutes
and
programs
implemented
by
the
agencies,
which
vary
from
one
agency
to
the
next.
Thus,
we
did
not
add
a
definition.
6.
A
commentator
questioned
whether
federal
contractors
are
intended
to
be
included
within
the
definition
of
``
agency.''
Federal
contractors
do
not
fall
within
the
definition
of
``
agency.''
However,
if
a
federal
contractor
participates
in
a
voluntary
consensus
standards
body
on
behalf
of
an
agency
(
i.
e.,
as
an
agency
representative
or
liaison),
then
the
contractor
must
comply
with
the
``
participation''
policies
in
section
7
of
this
Circular
(
i.
e.,
it
may
not
dominate
the
proceedings
of
a
voluntary
consensus
standards
body.).

Proposed
Section
5b
 
Conformity
Assessment.
Final
Section
8
7.
In
response
to
the
large
number
of
commentators
with
concerns
over
the
definition
of
conformity
assessment,
we
have
decided
to
not
define
the
term
in
this
Circular
but
to
defer
to
NIST
when
it
issues
its
guidance
on
the
subject.
The
Circular's
policy
statement
on
conformity
assessment
is
limited
to
the
statutory
language.

Proposed
Section
5c
 
Definition
of
Impractical.
Final
Section
6a(
2)

8.
A
commentator
suggested
that
if
an
agency
determines
the
use
of
a
standard
is
impractical,
the
agency
must
develop
an
explanation
of
the
reasons
for
impracticality
and
the
steps
necessary
to
overcome
the
use
of
the
impractical
reason.
We
decided
that
no
change
is
necessary.
The
Act
and
the
Circular
already
require
agencies
to
provide
an
``
explanation
of
the
reasons.''
Requiring
agencies
to
describe
the
steps
necessary
``
to
overcome
the
use
of
the
impractical
reason''
is
unnecessarily
burdensome
and
not
required
by
the
Act.
9.
A
commentator
suggested
that
the
definition
of
``
impractical''
is
too
broad
and
proposed
deleting
words
such
as
``
infeasible''
or
``
inadequate.''
We
have
decided
that
the
definition
is
appropriate,
because
things
that
are
infeasible
or
inadequate
are
commonly
considered
to
be
impractical.
Thus,
we
made
no
change.
10.
A
commentator
suggested
eliminating
the
phrase
``
unnecessarily
duplicative''
because
it
is
unlikely
that
a
voluntary
consensus
standard
that
was
considered
``
impractical''
would
also
be
``
unnecessarily
duplicative.''
We
agree,
and
the
final
Circular
is
modified
accordingly.
11.
A
few
commentators
suggested
adding
``
ineffectual''
to
the
definition.
A
few
other
commentators
suggested
adding
the
phrase
``
too
costly
or
burdensome
to
the
agency
or
regulated
community.''
Another
commentator
suggested
the
same
phrase
but
substituted
the
term
``
affected''
for
``
regulated.''
We
have
decided
that
concerns
for
regulatory
cost
and
burden
fall
under
the
term
``
inefficient''
contained
in
this
definition.
Thus,
we
made
no
change.
12.
A
few
commentators
suggested
deleting
the
term
``
demonstrably''
as
it
implies
a
greater
level
of
proof
than
that
required
in
the
Act.
Upon
consideration,
we
have
decided
that
the
term
``
demonstrably''
is
unnecessary,
as
the
Act
already
requires
an
explanation,
and
it
may
be
reasonably
inferred
that
an
explanation
can
be
demonstrated.
Thus,
we
deleted
the
term.

Proposed
Section
5d
 
Definition
of
Performance
Standard.
Final
Section
3c
13.
A
commentator
suggested
deleting
the
``
and''
in
the
definition.
We
have
decided
that
this
suggestion
would
distort
the
meaning.
Therefore,
no
change
is
made.
14.
A
few
commentators
suggested
substituting
the
term
``
prescriptive''
for
``
design''
because
of
the
multiple
connotations
associated
with
the
term
``
design.''
In
addition,
several
commentators
suggested
related
clarifying
language.
We
agree,
and
we
modified
the
final
Circular.

Proposed
Section
5f
 
Definition
of
Standard.
Final
Section
3
15.
Several
commentators
suggested
overall
clarification
of
this
section,
while
other
commentators
endorsed
the
proposed
section.
One
commentator
suggested
that
``
clarification
is
necessary
to
distinguish
the
appropriate
use
of
different
types
of
standards
for
different
purposes
(
i.
e.,
acquisition,
procurement,
regulatory).''
This
commentator
proposed
that,
``
For
example,
regulatory
Agencies
should
only
rely
upon
national
voluntary
consensus
standards
(
as
defined
in
Section
5j)
for
use
as
technical
criteria
in
regulations
but
a
federal
agency
may
want
to
use
industry­
developed
standards
(
without
a
full
consensus
process)
for
certain
acquisition
purposes
if
there
are
no
comparable
consensus
standards.''
We
do
not
agree
with
this
proposal.
The
same
general
principles
apply
in
the
procurement
context
as
in
the
regulatory
context.
16.
A
commentator
suggested
that
the
definition
of
``
standard''
be
limited
to
ensure
that
agencies
are
only
required
to
consider
adopting
voluntary
``
technical''
standards.
The
final
Circular
clarifies
this
by
clearly
equating
``
standard''
with
``
technical
standard.''
17.
One
commentator
recommended
adding
to
the
definition
of
``
standard''
an
exclusion
for
State
and
local
statutes,
codes,
and
ordinances,
because
agency
contracts
often
require
contractors
to
meet
State
and
local
building
codes,
which
contain
technical
standards
which
may
not
be
consensus­
based.
For
example,
the
Department
of
Energy
builds
facilities
that
must
be
compliant
with
local
building
codes,
which
may
be
more
strict
than
nationally
accepted
codes.
It
is
not
the
intent
of
this
policy
to
preclude
agencies
from
complying
with
State
and
local
statutes,
codes,
and
ordinances.
No
change
is
necessary,
because
the
Act
already
states
that,
``
If
compliance
*
*
*
is
inconsistent
with
applicable
law
*
*
*
a
Federal
agency
may
elect
to
use
technical
standards
that
are
not
developed
or
adopted
by
voluntary
consensus
standards
bodies.''

Proposed
Section
5f
 
Definition
of
Standard.
Final
Section
4
18.
Several
commentators
had
concerns
with
this
section,
believing
that
the
final
sentence
in
the
proposed
8548
Federal
Register
/
Vol.
63,
No.
33
/
Thursday,
February
19,
1998
/
Notices
version
might
imply
that
other­
thanconsensus
standards
may
qualify
as
consensus
processes.
This
is
not
the
case.
We
have
clarified
this
point
through
the
reorganization
of
final
sections
3
and
4
and
through
minor
clarifying
language.
In
addition,
we
note
that
the
subject
of
the
Circular
is
``
voluntary
consensus
standards,''
which
are
a
subset
of
``
standards.''
Consistent
with
the
1993
version,
the
final
Circular
defines
``
standard''
generally
to
describe
all
the
different
types
of
standards,
whether
or
not
they
are
consensus­
based,
or
industry­
or
company­
based.
Accordingly,
we
have
inserted
the
phrase
``
governmentunique
in
final
section
4b(
2)
in
order
to
provide
a
complete
picture
of
the
different
sources
of
standards,
while
also
adding
a
reference
to
``
company
standards''
in
final
section
4b(
1),
previously
found
in
the
definition
of
``
standard.''

Proposed
Section
5g
 
Definition
of
Technical
Standard.
Final
Section
3a
19.
Several
commentators
suggested
combining
this
term
with
the
definition
of
standard.
We
agree,
and
the
terms
have
been
merged.
20.
Another
commentator
suggested
adding
the
phrase
``
and
related
management
practices''
because
this
phrase
appears
in
Section
12(
d)(
4)
of
the
Act.
We
agree,
and
we
modified
the
final
Circular.

Proposed
Section
5h
 
Definition
of
Use.
Final
Section
6a(
1)

21.
Several
commentators
suggested
that
limiting
an
agency's
use
to
the
latest
edition
of
a
voluntary
consensus
standard
was
unnecessarily
restrictive.
We
agree,
and
we
modified
the
final
Circular.

Proposed
Section
5i
 
Definition
of
Voluntary
Consensus
Standards.
Final
Section
4
22.
Several
commentators
objected
to
the
phrase
regarding
making
``
intellectual
property
available
on
a
non­
discriminatory,
royalty­
free
or
reasonable
royalty
basis
to
all
interested
parties.''
Several
commentators
also
supported
this
language.
This
section
does
not
limit
the
ability
of
copyright
holders
to
receive
reasonable
and
fair
royalties.
Accordingly,
we
made
no
change.

Proposed
Section
5j
 
Voluntary
Consensus
Standards
Bodies.
Final
Section
4a(
1)

23.
Several
commentators
proposed
that
the
words
``
but
not
necessarily
unanimity''
be
inserted
for
clarification.
We
agree,
and
we
modified
the
final
Circular.
24.
A
commentator
suggested
deleting
the
examples
of
voluntary
consensus
standards
bodies.
We
agree
that
the
examples
were
unnecessary
and
confusing,
and
we
modified
the
final
Circular.
25.
A
few
commentators
suggested
that
the
Circular
acknowledge
the
American
National
Standards
Institute
(
ANSI)
as
the
means
of
identifying
voluntary
consensus
standards
bodies.
Since
the
purpose
of
the
Circular
is
to
provide
general
principles,
rather
than
make
determinations
about
specific
organizations
or
guides,
these
determinations
will
be
made
by
agencies
in
their
implementation
of
the
Act.
Thus,
we
made
no
change.
26.
A
commentator
suggested
that
the
definition
be
modified
so
``
that
only
those
organizations
that
permit
an
acceptable
level
of
participation
and
approval
by
U.
S.
interests
can
be
considered
to
qualify.''
We
have
decided
that
no
change
is
necessary,
because
the
requirements
of
consensus
 
openness,
balance
of
interests,
and
due
process
 
likewise
apply
to
international
organizations.
27.
The
same
commentator
suggested
adding
the
phrase
``
the
absence
of
sustained
opposition''
to
the
definition
of
``
consensus.''
Although
we
did
not
make
this
change,
we
added
other
language
that
improves
the
definition.
28.
Several
commentators
proposed
that
the
Circular
further
clarify
aspects
of
this
section,
including
further
definitions
of
``
balance
of
interest,''
``
openness,''
and
``
due
process.''
We
have
decided
that
the
definition
provided
is
sufficient
at
this
time,
and
no
change
is
made.
29.
Several
commentators
proposed
that
this
definition
should
be
``
clarified
to
state
the
Federal
agencies
considering
the
use
of
voluntary
consensus
standards,
not
the
organizations
themselves,
are
to
decide
whether
particular
organizations
qualify
as
voluntary
consensus
standards
bodies
by
meeting
the
operational
requirements
set
out
in
the
definition.''
For
purposes
of
complying
with
the
policies
of
this
Circular,
agencies
may
determine,
according
to
criteria
enumerated
in
final
section
4,
whether
a
standards
body
qualifies.
However,
it
is
the
domain
of
the
private
sector
to
accredit
voluntary
consensus
standards
organizations,
and
accordingly,
we
have
inserted
clarifying
language
in
final
section
6l.

Proposed
Section
6a.
Final
Section
6c
30.
A
commentator
proposed
deleting
in
section
6a
``
procurement
guidelines''
suggesting
it
was
confusing
and
inappropriate
to
mandate
use
of
voluntary
consensus
standards
for
``
procurement
guidelines
or
procedures.''
We
have
decided
to
delete
the
reference
to
``
procurement
guidelines.''
The
Circular
says
nothing
about
``
procurement
procedures.''
31.
The
same
commentator
suggested
adding
in
section
6a
``
monitoring
objectives''
as
part
of
an
agency's
regulatory
authorities
and
responsibilities.
We
have
decided
that,
under
the
Act
and
the
Circular,
agencies
already
have
sufficient
discretion
regarding
the
use
and
non­
use
of
standards
relating
to
such
authorities
and
responsibilities.
Thus,
we
have
made
no
change.

Proposed
Section
6a.
Final
Section
6f
32.
Some
commentators
expressed
concern
that
once
a
standard
was
determined
to
be
a
voluntary
consensus
standard,
an
agency
might
incorporate
such
standard
into
a
regulation
without
performing
the
proper
regulatory
analysis.
To
address
this
concern,
another
commentator
suggested
adding
language
referencing
``
The
Principles
of
Regulation''
enumerated
in
Section
1(
b)
of
Executive
Order
12866.
We
agree,
and
we
modified
the
final
Circular.

Proposed
Section
6b.
Final
Section
7
33.
In
the
proposed
revision
of
the
Circular,
sections
6b
and
7b(
2)
were
strengthened
by
adding
language
that
directed
agency
representatives
to
refrain
from
actively
participating
in
voluntary
consensus
standards
bodies
or
their
committees
when
participating
did
not
relate
to
the
mission
of
the
agency.
Several
commentators
were
not
satisfied
with
these
changes
and
remain
concerned
that
an
agency
member
might
dominate
a
voluntary
consensus
standards
body
as
a
result
of
the
agency
member
chairing
and/
or
providing
funding
to
such
body,
thus
making
the
process
not
truly
consensus.
These
commentators
urged
additional
limitations
on
agency
participation
in
voluntary
consensus
standards
bodies,
including:
Prohibiting
federal
agency
representatives
from
chairing
committees
or
voting
(
or
if
chairing
a
committee,
then
denying
them
the
authority
to
select
committee
members);
having
only
an
advisory
role;
participating
only
if
directly
related
to
an
agency's
mission
or
statutory
authority;
and
participating
only
if
there
is
an
opportunity
for
a
third
party
challenge
to
the
participation
through
a
public
hearing.
On
the
other
hand,
most
commentators
supported
the
proposed
changes
and
agreed
that
federal
participation
in
voluntary
consensus
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/
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/
Thursday,
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19,
1998
/
Notices
standards
bodies
should
not
be
further
limited,
because
federal
participation
benefited
both
the
government
and
the
private
sector.
These
commentators
noted
that
agencies
must
be
involved
in
the
standards
development
process
to
provide
a
true
consensus
and
to
help
support
the
creation
of
standards
for
agency
use.
These
purposes
are
consistent
with
the
intent
of
the
Act.
In
the
final
Circular,
we
have
added
language
to
clarify
the
authorities
in
the
Circular.
We
have
also
strengthened
the
final
Circular
by
adding
language
in
final
section
7f
that
directs
agency
employees
to
avoid
the
practice
or
the
appearance
of
undue
influence
relating
to
their
agency
representation
in
voluntary
consensus
standards
activities.
We
would
also
like
to
underscore
the
importance
of
close
cooperation
with
the
private
sector,
including
standards
accreditors,
in
ensuring
that
federal
participation
is
fair
and
appropriate.
With
respect
to
imposing
specific
limitations
on
agency
participation
in
such
bodies,
which
would
result
in
unequal
participation
relative
to
other
members,
we
have
decided
that
such
limitations
would
(
1)
not
further
the
purposes
of
the
Act
and
(
2)
could
interfere
with
the
internal
operations
of
voluntary
consensus
standards
organizations.
First,
the
Act
requires
agencies
to
consult
with
voluntary
consensus
standards
bodies
and
to
participate
with
such
bodies
in
the
development
of
technical
standards
``
when
such
participation
is
in
the
public
interest
and
is
compatible
with
agency
and
departmental
missions,
authorities,
and
budget
resources.''
The
legislative
history
indicates
that
one
of
the
purposes
of
the
Act
is
to
promote
federal
participation.
[
See
141
Cong.
Rec.
H14334
(
daily
ed.
December
12,
1995)
(
Statement
of
Rep.
Morella.)]
Moreover,
neither
the
Act
nor
its
legislative
history
indicate
that
federal
agency
representatives
are
to
have
less
than
full
and
equal
representation
in
such
bodies.
Given
the
explicit
requirement
to
consult
and
participate
and
no
concomitant
statement
as
to
any
limitation
on
this
participation,
we
believe
the
Act
was
intended
to
promote
full
and
equal
participation
in
voluntary
consensus
standards
bodies
by
federal
agencies.
Second,
although
an
agency
is
ultimately
responsible
for
ensuring
that
its
members
are
not
participating
in
voluntary
consensus
standards
bodies
in
a
manner
inconsistent
with
the
Circular
and
the
Act,
it
would
be
inappropriate
for
the
federal
government
to
direct
the
internal
operations
of
private
sector
voluntary
consensus
standards
bodies
or
standards
development
organizations
(
SDOs)
by
proscribing
the
activities
of
any
of
its
members.
The
membership
of
an
SDO
is
free
to
choose
a
chair,
to
establish
voting
procedures,
and
to
accept
funding
as
deemed
appropriate.
We
expect
that
the
SDO
itself
or
a
related
parent
or
accrediting
organization
would
act
to
ensure
that
the
organization's
proceedings
remain
fair
and
balanced.
An
SDO
has
a
vested
interest
in
ensuring
that
its
consensus
procedures
and
policies
are
followed
in
order
to
maintain
its
credibility.

Proposed
Section
6b.
Final
Sections
7e,
7f,
and
7h
34.
Other
commentators
were
concerned
that
an
agency
representative
could
participate
in
the
proceedings
of
a
voluntary
consensus
standards
body
for
which
the
agency
has
no
missionrelated
or
statutorily­
based
rationale
to
become
involved.
For
example,
a
situation
might
exist
in
which
a
technical
standard
developed
by
the
private
sector
could
be
so
widely
adopted
as
to
result
in
the
emergence
of
a
de
facto
regulatory
standard,
albeit
one
endorsed
by
the
private
sector
rather
than
by
the
government.
For
example,
a
construction
standard
for
buildings
could
become
so
widely
accepted
in
the
private
sector
that
the
result
is
that
the
construction
community
acts
as
if
it
is
regulated
by
such
standards.
The
commentator
suggested
that
if
an
agency
were
to
participate
in
the
development
of
such
a
technical
standard,
in
an
area
for
which
it
has
no
specific
statutory
authority
to
regulate,
that
agency
could
be
perceived
as
attempting
to
regulate
the
private
sector
``
through
the
back
door.''
A
perception
of
such
activity,
whether
or
not
based
in
fact,
would
be
detrimental
to
the
interests
of
the
federal
government,
and
agencies
should
avoid
such
involvement.
In
response
to
this
concern,
we
feel
that
changes
initiated
in
the
proposed
revision
and
continued
in
the
final
Circular
sufficiently
strengthened
the
Circular
in
this
regard.
In
particular,
section
7
expressly
limits
agency
support
(
e.
g.,
funding,
participation,
etc.)
to
``
that
which
clearly
furthers
agency
and
departmental
missions,
authorities,
priorities,
and
budget
resources.''
Moreover,
this
language
is
consistent
with
the
Act.
Thus,
if
an
agency
has
no
mission­
related
or
statutory­
related
purpose
in
participation,
then
its
participation
would
be
contrary
to
the
Circular.
An
agency
is
ultimately
responsible
for
ensuring
that
its
employees
are
not
participating
in
such
bodies
in
a
manner
inconsistent
with
the
Act
or
this
Circular.
Agencies
should
monitor
their
participation
in
voluntary
consensus
standards
bodies
to
prevent
situations
in
which
the
agency
could
dominate
proceedings
or
have
the
appearance
of
impropriety.
Agencies
should
also
work
closely
with
private
sector
oversight
organizations
to
ensure
that
no
abuses
occur.
Comments
provided
by
ANSI
described
the
extensive
oversight
mechanisms
it
maintains
in
order
to
ensure
that
such
abuses
do
not
occur.
We
encourage
this
kind
of
active
oversight
on
the
part
of
the
private
sector,
and
we
hope
to
promote
cooperation
between
the
agencies
and
the
private
sector
to
ensure
that
federal
participation
remains
fair
and
equal.

Proposed
Section
7
 
Policy
Guidelines.
Final
Section
6c
35.
A
few
commentators
inquired
whether
the
Circular
applies
to
``
regulatory
standards.''
In
response,
the
final
Circular
distinguishes
between
a
``
technical
standard,''
which
may
be
referenced
in
a
regulation,
and
a
``
regulatory
standard,''
which
establishes
overall
regulatory
goals
or
outcomes.
The
Act
and
the
Circular
apply
to
the
former,
but
not
to
the
latter.
As
described
in
the
legislative
history,
technical
standards
pertain
to
``
products
and
processes,
such
as
the
size,
strength,
or
technical
performance
of
a
product,
process
or
material''
and
as
such
may
be
incorporated
into
a
regulation.
[
See
142
Cong.
Rec.
S1080
(
daily
ed.
February
7,
1996)
(
Statement
of
Sen.
Rockefeller.)]
Neither
the
Act
nor
the
Circular
require
any
agency
to
use
private
sector
standards
which
would
set
regulatory
standards
or
requirements.

Proposed
Section
7.
Final
Section
6g
36.
A
commentator
inquired
whether
the
use
of
non­
voluntary
consensus
standards
meant
use
of
any
standards
developed
outside
the
voluntary
consensus
process,
or
just
use
of
government­
unique
standards.
The
intent
of
the
Circular
over
the
years
has
been
to
discourage
the
government's
reliance
on
government­
unique
standards
and
to
encourage
agencies
to
instead
rely
on
voluntary
consensus
standards.
It
is
has
not
been
the
intent
of
the
Circular
to
create
the
basis
for
discrimination
among
standards
developed
in
the
private
sector,
whether
consensus­
based
or,
alternatively,
industry­
based
or
company­
based.
Accordingly,
we
added
language
to
clarify
this
point.

Proposed
Section
7.
Final
Section
6f
37.
One
commentator
inquired
how
OMB
planned
to
carry
out
the
``
full
8550
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/
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1998
/
Notices
account''
of
the
impact
of
this
policy
on
the
economy,
applicable
federal
laws,
policies,
and
national
objectives.
This
language
is
from
the
current
Circular
and
refers
to
the
considerations
agencies
should
make
when
considering
using
a
standard.
No
change
is
necessary.

Proposed
Section
7.
Final
Section
17
38.
Several
commentators
noted
that
the
proposed
revision
eliminated
language
from
the
current
Circular
which
stated
that
its
provisions
``
are
intended
for
internal
management
purposes
only
and
are
not
intended
to
(
1)
create
delay
in
the
administrative
process,
(
2)
provide
new
grounds
for
judicial
review,
or
(
3)
create
legal
rights
enforceable
against
agencies
or
their
officers.''
We
have
decided
that,
while
some
sections
of
the
Circular
incorporate
statutory
requirements,
other
sections
remain
internal
Executive
Branch
management
policy.
Accordingly,
we
have
retained
the
language,
with
minor
revisions.

Proposed
Section
7a
39.
One
commentator
inquired
as
to
whether
the
use
of
a
voluntary
consensus
standard
by
one
agency
would
mandate
that
another
agency
must
use
such
standard.
Implementation
of
the
policies
of
the
Circular
are
on
an
agency
by
agency
basis,
and
in
fact,
on
a
case
by
case
basis.
Agencies
may
have
different
needs
and
requirements,
and
the
use
of
a
voluntary
consensus
standard
by
one
agency
does
not
require
that
another
agency
must
use
the
same
standard.
Each
agency
has
the
authority
to
decide
whether,
for
a
program,
use
of
a
voluntary
consensus
standard
would
be
contrary
to
law
or
otherwise
impractical.
40.
Another
comment
suggested
that
the
Circular
did
not
contain
sufficient
assurance
that
the
standards
chosen
would
be
true
consensus
standards.
We
have
expanded
the
guidance
in
the
Circular
to
address
this
concern
by
first
expanding
the
definition
of
``
consensus''
in
final
section
4a(
1)(
v).
Second,
we
have
described
in
final
section
6l
how
agencies
may
identify
voluntary
consensus
standards.
Third,
we
have
developed
reporting
procedures
that
allow
for
public
comment.

Proposed
Section
7a(
1).
Final
Section
6h
41.
Several
commentators
suggested
that
``
international
voluntary
consensus
standards
body''
be
defined
in
proposed
section
5.
We
have
decided
that
this
definition
is
not
necessary,
as
the
term
``
international''
is
sufficiently
well
understood
in
the
standards
community,
and
the
term
``
voluntary
consensus
standards
body''
has
already
been
defined.
Moreover,
the
distinction
between
``
international
standards''
and
``
domestic
standards''
is
not
relevant
to
the
essential
policies
of
the
Circular,
and
this
point
is
clarified
in
this
section.
42.
Several
commentators
also
noted
that
two
trade
agreements
(``
TBT''
and
the
``
Procurement
Code'')
of
the
World
Trade
Organization
were
mentioned
but
inquired
as
to
why
other
international
agreements
like
the
World
Trade
Organization
Agreement
on
Sanitary
and
Phytosanitary
Measures
or
the
North
American
Free
Trade
Agreement
were
not
mentioned.
We
did
not
intend
this
list
to
be
exhaustive.
Therefore,
we
deleted
this
phrase
to
emphasize
the
main
point
of
this
section.
43.
Several
commentators
questioned
why
the
Circular
included
language
that
standards
developed
by
international
voluntary
consensus
standards
bodies
``
should
be
considered
in
procurement
and
regulatory
applications.''
We
recognize
that
both
domestic
and
international
voluntary
consensus
standards
may
exist,
sometimes
in
harmony,
sometimes
in
competition.
This
language,
which
is
unchanged
from
the
current
version
of
the
Circular,
states
only
that
such
international
standards
should
be
``
considered,''
not
that
they
are
mandated
or
that
they
should
be
given
any
preference.
In
addition,
some
confusion
has
emerged
based
on
a
perceived
conflict
between
the
commitments
of
the
United
States
with
respect
to
international
treaties
and
this
Circular.
No
part
of
this
Circular
is
intended
to
preempt
international
treaties.
Nor
is
this
Circular
intended
to
create
the
basis
for
discrimination
between
an
international
and
a
domestic
voluntary
consensus
standard.
However,
wherever
possible,
agencies
should
consider
the
use
of
international
voluntary
consensus
standards.

Proposed
Section
7a(
2).
Final
Section
6i
44.
One
commentator
suggested
that
the
Circular
promote
the
concept
of
performance­
based
requirements
when
regulating
the
conduct
of
work
for
safety
or
health
reasons
(
e.
g.,
safety
standards).
Where
performance
standards
can
be
used
in
lieu
of
other
types
of
standards
(
or
technical
standards),
the
Circular
already
accomplishes
this
by
stating
in
final
section
6i
that
``
preference
should
be
given
to
standards
based
on
performance
criteria.''

Proposed
Section
7a(
3).
Final
Section
6j
45.
One
commentator
suggested
using
stronger
language
to
protect
the
rights
of
copyright
holders
when
referenced
in
a
regulation.
Others
thought
the
language
too
strong.
We
have
decided
that
the
language
is
just
right.

Proposed
Section
7a(
4).
Final
Section
6k,
7j
46.
One
commentator
suggested
that
legal
obligations
that
supersede
the
Circular
and
cost
and
time
burdens
need
to
be
emphasized
as
factors
supporting
agencies'
developing
and
using
their
own
government­
unique
standards.
Another
commentator
suggested
that
untimeliness
or
unavailability
of
voluntary
consensus
standards
development
should
be
a
reasonable
justification
for
creation
of
a
government
standard.
On
the
first
point,
these
specific
changes
are
not
necessary,
because
the
Act
and
the
Circular
already
state
that
agencies
may
choose
their
own
standard
``
where
inconsistent
with
applicable
law
or
otherwise
impractical.''
On
the
second
point,
we
did
clarify
the
language
in
final
sections
6k
and
7j.
47.
Another
commentator
suggested
that
the
Circular
should
define
in
this
section
factors
that
are
considered
to
be
``
impractical.''
See
comments
on
proposed
section
5c.
We
made
no
change.

Proposed
Section
7a(
5).
Final
Section
6l.
48.
This
section
is
intended
to
give
agencies
guidance
on
where
they
may
go
to
identify
voluntary
consensus
standards.
One
commentator
proposed
language
to
indicate
that,
in
addition
to
NIST,
voluntary
consensus
standards
may
also
be
identified
through
other
federal
agencies.
Another
commentator
proposed
language
that
such
standards
may
also
be
identified
through
standards
publishing
companies.
We
agree,
and
the
Circular
is
changed.

Proposed
Section
7b
49.
Other
commentators
proposed
that
Federal
Register
notices
be
published
whenever
a
federal
employee
is
to
participate
in
a
voluntary
consensus
standards
body.
We
have
decided
that
this
would
be
overly
burdensome
for
the
agencies
and
would
provide
comparatively
little
benefit
for
the
public.
Moreover,
each
agency
is
already
required
in
section
15b(
5)
to
publish
a
directory
of
federal
participants
in
standards
organizations.
We
made
no
change.

Proposed
Section
7b(
2).
Final
Section
7d
50.
Some
commentators
noted
that
the
current
Circular's
language,
which
states
that
agency
employees
who
``
at
government
expense''
participate
in
voluntary
consensus
standards
bodies
shall
do
so
as
specifically
authorized
agency
representatives,
has
been
deleted
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/
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19,
1998
/
Notices
from
the
proposed
revision.
These
commentators
opposed
this
deletion.
This
phrase
has
been
reinstated.
Federal
employees
who
are
representing
their
agency
must
do
so
at
federal
expense.
(
On
the
other
hand,
employees
are
free
to
maintain
personal
memberships
in
outside
organizations,
unless
the
employee's
agency
has
a
requirement
for
prior
approval.)
We
expect
that,
as
a
general
rule,
federal
participation
in
committees
will
not
be
a
problem,
while
participation
at
higher
levels,
such
as
officers
or
as
directors
on
boards,
will
require
additional
scrutiny.
Employees
should
consult
with
their
agency
ethics
officer
to
identify
what
restrictions
may
apply.

Proposed
Section
7b(
2).
Final
Section
7
51.
Several
commentators
suggested
changing
the
language
in
this
section
from
``
permitting
agency
participation
when
relating
to
agency
mission,''
to
``
permitting
agency
participation
when
compatible
with
agency
and
departmental
missions,
authorities,
priorities,
and
budget
resources,''
as
stated
in
the
Act.
We
have
decided
to
accept
this
suggestion,
and
the
Circular
is
changed.

Proposed
Section
7b(
4).
Final
Sections
7d,
7g
52.
One
commentator
suggested
that
the
Circular
should
prohibit
agency
employees
from
serving
as
chairs
or
board
members
of
voluntary
consensus
standards
bodies.
We
have
not
amended
the
Circular
to
prohibit
agency
employees
from
serving
as
chairs
or
board
members
of
voluntary
consensus
standards
bodies.
However,
we
have
modified
final
section
7g
to
clarify
that
agency
employees,
whether
or
not
in
a
position
of
leadership
in
a
voluntary
consensus
standards
body,
must
avoid
the
practice
or
appearance
of
undue
influence
relating
to
the
agency's
representation
and
activities
in
the
voluntary
consensus
standards
bodies.
In
addition,
we
added
language
in
final
section
7d
to
remind
agencies
to
involve
their
agency
ethics
officers,
as
appropriate,
prior
to
authorizing
support
for
or
participation
in
a
voluntary
consensus
standards
body.

Proposed
Section
7b(
5).
Final
Section
7h
53.
One
commentator
suggested
changing
the
word
``
should''
to
``
shall''
regarding
keeping
the
number
of
individual
agency
participants
to
a
minimum.
We
decided
that
this
change
is
unnecessary
and
made
no
change.

Proposed
Section
7b(
6)
54.
A
few
commentators
suggested
requiring
that
the
amount
of
federal
support
should
be
made
public
or
at
least
made
known
to
the
supported
committee
of
the
voluntary
consensus
standards
body
or
SDO.
We
have
decided
that
this
is
unnecessary
because
we
expect
that
the
amount
of
federal
support
will
already
be
known
to
a
committee
receiving
the
funds.

Proposed
Section
7b(
7).
Final
Section
7g
55.
A
commentator
suggested
either
deleting
``
and
administrative
policies''
or
inserting
``
internal''
before
``
administrative
policies''
to
clarify
that
the
prohibition
is
intended
to
apply
to
the
internal
management
of
a
voluntary
consensus
standard
body.
This
phrase
is
parenthetical
to
the
words
``
internal
management;''
thus,
the
suggested
revision
is
unnecessary.

Proposed
Section
7b(
8).
Final
Section
7i
56.
One
commentator
questioned
the
relationship
of
the
Circular
to
the
Federal
Advisory
Committee
Act
(
FACA).
Federal
participation
in
standards
activities
would
not
ordinarily
be
subject
to
FACA,
because
FACA
applies
to
circumstances
in
which
private
individuals
would
be
advising
the
government.
The
private
sector
members
of
standards
organizations
are
not
advising
the
government,
but
are
developing
standards.
Nevertheless,
issues
may
arise
in
which
agencies
should
be
aware
of
FACA.

Proposed
Section
7b.
Final
Sections
7e,
7f
57.
Several
commentators,
fearing
agency
dominance,
criticized
the
proposed
revision
of
the
Circular
for
promoting
increased
agency
participation.
We
have
decided
that
the
revisions
to
the
Circular
are
balanced,
in
that
they
encourage
agency
participation
while
also
discouraging
agency
dominance.
Moreover,
legislative
history
states,
``
In
fact,
it
is
my
hope
that
this
section
will
help
convince
the
Federal
Government
to
participate
more
fully
in
these
organizations'
standards
developing
activities.''
[
See
141
Cong.
Rec.
H14334
(
daily
ed.
December
12,
1995)
(
Statement
of
Rep.
Morella.)]

Proposed
7c
(
4).
Final
Section
15b
58.
A
commentator
suggested
changing
``
standards
developing
groups''
to
``
voluntary
consensus
standards
bodies''
for
consistency.
We
agree,
and
we
modified
the
final
Circular.

Proposed
7c(
6).
Final
Section
15b(
7)

59.
The
current
and
proposed
versions
of
the
Circular
required
agencies
to
review
their
existing
standards
every
five
years
and
to
replace
through
applicable
procedures
such
standards
that
can
be
replaced
with
voluntary
consensus
standards.
Several
commentators
suggested
adding
language
that
either
requires
agencies
to
review
standards
referenced
in
regulations
on
an
annual
basis
or
an
ongoing
basis.
Other
commentators
proposed
extending
the
review
period
to
ten
years
(
in
order
to
mirror
the
review
cycle
of
the
Regulatory
Flexibility
Act)
or
to
eliminate
the
review
entirely
because
it
was
burdensome.
We
decided
to
change
this
requirement
to
one
in
which
agencies
are
responsible
for
``
establishing
a
process
for
ongoing
review
of
the
agency's
use
of
standards
for
purposes
of
updating
such
use.''
We
decided
that
this
approach
will
encourage
agencies
to
review
the
large
numbers
of
regulations
which
may
reference
obsolete
and
outdated
standards
in
a
timely
manner.
Agencies
are
encouraged
to
undertake
a
review
of
their
uses
of
obsolete
or
government­
unique
standards
as
soon
as
practicable.
60.
A
commentator
proposed
language
to
require
agencies
to
respond
to
requests
from
voluntary
consensus
standards
bodies
to
replace
existing
federal
standards,
specifications,
or
regulations
with
voluntary
consensus
standards.
This
change
is
not
necessary,
because
the
Circular
already
requires
agencies
to
establish
a
process
for
reviewing
standards.
(
See
comment
59.)
We
made
no
change.

Proposed
Section
8.
Final
Section
11
61.
Several
commentators
suggested
eliminating
the
requirement
in
the
proposed
Circular
for
an
analysis
of
the
use
and
non­
use
of
voluntary
consensus
standards
in
both
the
Notice
of
Proposed
Rulemaking
(
NPRM)
and
the
final
rule
in
order
to
simplify
and
clarify
Federal
Register
notices.
As
an
alternative,
these
commentators
proposed
including
such
analysis
in
a
separate
document
that
accompanies
the
NPRM
and
the
subsequent
final
rule.
We
have
decided
that,
rather
than
simplifying
the
rulemaking
process,
this
change
would
make
it
more
difficult
for
the
public
to
comment
on
the
rule
and
would
complicate
the
process
by
adding
another
source
of
information
in
a
separate
location.
However,
we
did
make
some
minor
changes
to
this
section
to
clarify
that
agencies
are
not
expected
to
provide
an
extensive
report
with
each
NPRM,
Interim
Final
Rulemaking,
or
Final
Rule.
The
section
was
also
modified
to
improve
the
ability
of
agencies
to
identify
voluntary
consensus
standards
that
could
be
used
in
their
regulations,
to
ensure
public
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/
Notices
notice,
and
to
minimize
burden.
First,
the
notice
required
in
the
NPRM
may
merely
contain/
include
(
1)
a
few
sentences
to
identify
the
proposed
standard,
if
any;
and,
if
applicable,
(
2)
a
simple
explanation
of
why
the
agency
proposes
to
use
a
government­
unique
standard
in
lieu
of
a
voluntary
consensus
standard.
This
step
places
the
public
on
notice
and
gives
them
an
opportunity
to
comment
formally.
Second,
we
expect
that
the
majority
of
rulemakings
will
not
reference
standards
at
all.
In
these
cases,
the
agency
is
not
required
to
make
a
statement
or
to
file
a
report.
In
those
instances
where
an
agency
proposes
a
government­
unique
standard,
the
public,
through
the
public
comment
process,
will
have
an
opportunity
to
identify
a
voluntary
consensus
standard
(
when
the
agency
was
not
aware
of
it)
or
to
argue
that
the
agency
should
have
used
the
voluntary
consensus
standard
(
when
the
agency
had
identified
one,
but
rejected
it).
62.
Several
commentators
suggested
adding
a
new
section
entitled
``
Sufficiency
of
Agency
Search.''
The
purpose
of
this
new
section
would
be
to
limit
an
agency's
obligation
to
search
for
existing
voluntary
consensus
standards
under
the
requirements
of
this
section.
We
have
decided
that
this
section
is
unnecessary
in
light
of
the
requirements
elsewhere
in
the
Circular
for
identifying
voluntary
consensus
standards.
Accordingly,
we
made
no
change.
63.
One
commentator
suggested
that
agencies
be
required
to
fully
investigate
and
review
the
intent
and
capabilities
of
a
standard
before
making
a
decision
to
use
a
particular
voluntary
consensus
standard.
We
have
decided
that
the
effort
an
agency
would
have
to
undertake
to
conduct
its
own
scientific
review
of
a
voluntary,
consensus
standard
is
unnecessary,
as
SDOs
adhere
to
lengthy
and
complex
procedures
which
already
closely
scrutinize
the
uses
and
capabilities
of
a
standard.
However,
in
adopting
a
standard
for
use,
whether
in
procurement
or
in
regulation,
agencies
are
already
required
to
undertake
the
review
under
the
Act
and
the
Circular,
as
well
as
the
review
and
analysis,
described
in
other
sources,
such
as
the
Federal
Acquisition
Regulation
or
the
Executive
Order
12866
on
Regulatory
Planning
and
Review.
Accordingly,
we
made
no
change.
64.
A
few
commentators
suggested
that
the
Circular
should
ensure
prompt
notification
to
interested
parties
when
voluntary
consensus
standards
activities
are
about
to
begin
and
should
encourage
greater
public
participation
in
such
activities.
Another
commentator
noted
a
lack
of
clear
procedures
on
how
voluntary
consensus
standards
bodies
handle
public
comments
and
whether
those
comments
are
available
to
interested
persons
or
organizations.
OMB
has
determined
that
these
responsibilities
fall
within
the
jurisdiction
of
voluntary
consensus
standards
bodies
and
are
outside
the
scope
of
the
Act
and
the
Circular.
Accordingly,
we
made
no
change.

Proposed
Section
8.
Final
Sections
6g
and
12c
65.
A
few
commentators
requested
clarification
on
the
use
of
``
commercialoff
the­
shelf''
(``
COTS'')
products
as
they
relate
to
voluntary
consensus
standards.
In
response,
we
have
clarified
final
section
6g
to
state
that
this
policy
does
not
establish
preferences
between
products
developed
in
the
private
sector.
Final
section
12c
clarified
that
there
is
no
reporting
requirement
for
such
products.

Proposed
Section
9
 
Responsibilities.
Final
Sections
13,
14,
15
66.
Several
commentators
proposed
that
OMB
have
more
defined
oversight
responsibility
in
determining
whether
an
agency's
participation
in
a
voluntary
consensus
standards
body
is
consistent
with
the
Circular.
We
did
not
make
this
change.
Agency
Standards
Executives,
with
the
advice
of
the
Chair
of
the
ICSP,
are
responsible
for
ensuring
that
agencies
are
in
compliance
with
the
requirements
of
this
Circular.
With
respect
to
the
issue
of
``
agency
dominance''
of
SDOs,
we
expect
that
SDOs
will
likewise
ensure
that
members
abide
by
their
rules
of
conduct
and
participation,
working
closely
with
Standards
Executives
where
necessary
and
appropriate.
We
inserted
minor
clarifying
language
in
new
sections
13,
14,
and
15.

Proposed
9b(
2).
Final
Section
14c
67.
A
commentator
suggested
broadening
the
category
of
agencies
that
must
designate
a
standards
executive,
from
designating
those
agencies
with
a
``
significant
interest''
in
the
use
of
standards,
to
those
agencies
having
either
``
regulatory
or
procurement''
responsibilities.
We
decided
that
this
proposed
change
was
vague
and
would
only
confuse
the
scope
of
the
Circular.
Accordingly,
we
made
no
change.

Proposed
Section
10.
Final
Sections
9
and
10
68.
One
commentator
expressed
concern
that
the
reporting
requirements
would
require
agencies
to
report
reliance
on
commercial­
off­
the­
shelf
(
COTS)
products
as
a
decision
not
to
rely
on
voluntary
consensus
standards.
The
Act
and
the
Circular
do
not
limit
agencies'
abilities
to
purchase
COTS
or
other
products
or
services
containing
private
sector
standards.
The
Circular
specifically
excludes
reporting
of
COTS
procurements
in
final
section
12,
and
final
sections
9a
and
12
require
agencies
to
report
only
when
an
agency
uses
a
government­
unique
standard
in
lieu
of
an
existing
voluntary
consensus
standard.
Accordingly,
we
made
no
change.

Proposed
10b
 
Agency
Reports
on
Standards
Policy
Activities.
Final
Section
9b
69.
One
commentator
suggested
that
agencies
also
report
the
identity
of
standards
development
bodies
whose
standards
the
agency
relies
on
and
the
identities
of
all
the
standards
developed
or
used
by
such
bodies.
We
have
decided
that
it
would
be
unnecessary,
duplicative,
and
burdensome
to
require
agencies
to
identify
this
level
of
detail
in
the
annual
report.
The
identity
of
individual
standards
developed
by
a
standards
body
may
be
obtained
either
through
the
standards
body
or
through
a
standards
publishing
company.
In
addition,
agencies
are
already
required
to
provide
in
their
annual
report,
under
section
9b(
1),
the
number
of
voluntary
consensus
standards
bodies
in
which
an
agency
participates.
Moreover,
each
agency
is
required
under
section
15b(
5)
to
identify
the
standards
bodies
in
which
it
is
involved.
Accordingly,
we
made
no
change.

Proposed
10b(
3).
Final
Section
9b
70.
A
commentator
suggested
that
agencies
should
be
required
to
identify
federal
regulations
and
procurement
specifications
in
which
the
standards
were
``
withdrawn''
and
replaced
with
voluntary
consensus
standards.
We
have
decided
that
this
requirement
is
unnecessary,
because
information
is
already
provided
in
the
annual
report
described
in
final
section
9b(
3).
Accordingly,
we
made
no
change.

Proposed
Section
11
 
Conformity
Assessment.
Final
Section
8
71.
A
commentator
expressed
concern
that
the
coordination
by
the
National
Institute
of
Standards
and
Technology
(
NIST)
of
standards
activities
between
the
public
and
private
sector
will
undermine
the
coordination
that
ANSI
has
performed
for
many
years
for
the
private
sector.
In
addition,
the
commentator
expressed
concern
that
NIST's
involvement
in
such
coordination
will
undermine
the
United
States'
ability
to
8553
Federal
Register
/
Vol.
63,
No.
33
/
Thursday,
February
19,
1998
/
Notices
compete
internationally
as
two
organizations
are
coordinating
standards
developing
activities
instead
of
one.
The
Act
states
that
NIST
is
to
``
coordinate
Federal,
State,
and
local
technical
standards
activities
and
conformity
assessment
activities
with
private
sector
technical
standards
activities
and
conformity
assessment
activities.''
This
language
makes
clear
that
NIST
will
have
responsibility
for
coordinating
only
the
public
sector
and
for
working
with
the
private
sector.
In
addition,
ANSI's
role
is
affirmed
in
the
Memorandum
Of
Understanding
(
MOU)
issued
on
July
24,
1995,
between
NIST
and
ANSI.
The
MOU
states
``[
t]
his
MOU
is
intended
to
facilitate
and
strengthen
the
influence
of
ANSI
and
the
entire
U.
S.
standards
community
at
the
international
level
*
*
*
and
ensure
that
ANSI's
representation
of
U.
S.
interests
is
respected
by
the
other
players
on
the
international
scene.''
Thus,
we
made
no
change.
Accordingly,
OMB
Circular
A
 
119
is
revised
as
set
forth
below.
Sally
Katzen,
Administrator,
Office
of
Information
and
Regulatory
Affairs.

EXECUTIVE
OFFICE
OF
THE
PRESIDENT
Office
of
Management
and
Budget
Washington,
D.
C.
20503
February
10,
1998.

Circular
No.
A
 
119
Revised
Memorandum
for
Heads
of
Executive
Departments
and
Agencies
Subject:
Federal
Participation
in
the
Development
and
Use
of
Voluntary
Consensus
Standards
and
in
Conformity
Assessment
Activities
Revised
OMB
Circular
A
 
119
establishes
policies
on
Federal
use
and
development
of
voluntary
consensus
standards
and
on
conformity
assessment
activities.
Pub.
L.
104
 
113,
the
``
National
Technology
Transfer
and
Advancement
Act
of
1995,''
codified
existing
policies
in
A
 
119,
established
reporting
requirements,
and
authorized
the
National
Institute
of
Standards
and
Technology
to
coordinate
conformity
assessment
activities
of
the
agencies.
OMB
is
issuing
this
revision
of
the
Circular
in
order
to
make
the
terminology
of
the
Circular
consistent
with
the
National
Technology
Transfer
and
Advancement
Act
of
1995,
to
issue
guidance
to
the
agencies
on
making
their
reports
to
OMB,
to
direct
the
Secretary
of
Commerce
to
issue
policy
guidance
for
conformity
assessment,
and
to
make
changes
for
clarity.
Franklin
D.
Raines,
Director.

Attachment
EXECUTIVE
OFFICE
OF
THE
PRESIDENT
Office
of
Management
and
Budget
Washington,
D.
C.
20503
February
10,
1998.

Circular
No.
A
 
119
Revised
To
the
Heads
of
Executive
Departments
and
Establishments
Subject:
Federal
Participation
in
the
Development
and
Use
of
Voluntary
Consensus
Standards
and
in
Conformity
Assessment
Activities
TABLE
OF
CONTENTS
BACKGROUND
1.
What
Is
The
Purpose
Of
This
Circular?
2.
What
Are
The
Goals
Of
The
Government
Using
Voluntary
Consensus
Standards?

DEFINITIONS
OF
STANDARDS
3.
What
Is
A
Standard?
4.
What
Are
Voluntary,
Consensus
Standards?
a.
Definition
of
voluntary,
consensus
standard.
(
1)
Definition
of
voluntary,
consensus
standards
body.
b.
Other
types
of
standards.
(
1)
Non­
consensus
standards,
industry
standards,
company
standards,
or
de
facto
standards.
(
2)
Government­
unique
standards.
(
3)
Standards
mandated
by
law.

POLICY
5.
Who
Does
This
Policy
Apply
To?
6.
What
Is
The
Policy
For
Federal
Use
Of
Standards?
a.
When
must
my
agency
use
voluntary
consensus
standards?
(
1)
Definition
of
``
Use.''
(
2)
Definition
of
``
Impractical.''
b.
What
must
my
agency
do
when
such
use
is
determined
by
my
agency
to
be
inconsistent
with
applicable
law
or
otherwise
impractical?
c.
How
does
this
policy
affect
my
agency's
regulatory
authorities
and
responsibilities?
d.
How
does
this
policy
affect
my
agency's
procurement
authority?
e.
What
are
the
goals
of
agency
use
of
voluntary
consensus
standards?
f.
What
considerations
should
my
agency
make
when
it
is
considering
using
a
standard?
g.
Does
this
policy
establish
a
preference
between
consensus
and
non­
consensus
standards
that
are
developed
in
the
private
sector?
h.
Does
this
policy
establish
a
preference
between
domestic
and
international
voluntary
consensus
standards?
i.
Should
my
agency
give
preference
to
performance
standards?
j.
How
should
my
agency
reference
voluntary
consensus
standards?
k.
What
if
no
voluntary
consensus
standard
exists?
l.
How
may
my
agency
identify
voluntary
consensus
standards?
7.
What
Is
The
Policy
For
Federal
Participation
In
Voluntary
Consensus
Standards
Bodies?
a.
What
are
the
purposes
of
agency
participation?
b.
What
are
the
general
principles
that
apply
to
agency
support?
c.
What
forms
of
support
may
my
agency
provide?
d.
Must
agency
participants
be
authorized?
e.
Does
agency
participation
indicate
endorsement
of
any
decisions
reached
by
voluntary
consensus
standards
bodies?
f.
Do
agency
representatives
participate
equally
with
other
members?
g.
Are
there
any
limitations
on
participation
by
agency
representatives?
h.
Are
there
any
limits
on
the
number
of
federal
participants
in
voluntary
consensus
standards
bodies?
i.
Is
there
anything
else
agency
representatives
should
know?
j.
What
if
a
voluntary
consensus
standards
body
is
likely
to
develop
an
acceptable,
needed
standard
in
a
timely
fashion?
8.
What
Is
The
Policy
On
Conformity
Assessment?

Management
and
Reporting
of
Standards
Use
9.
What
Is
My
Agency
Required
To
Report?
10.
How
Does
My
Agency
Manage
And
Report
On
Its
Development
and
Use
Of
Standards?
11.
What
Are
The
Procedures
For
Reporting
My
Agency's
Use
Of
Standards
In
Regulations?
12.
What
Are
The
Procedures
For
Reporting
My
Agency's
Use
Of
Standards
In
Procurements?
a.
How
does
my
agency
report
the
use
of
standards
in
procurements
on
a
categorical
basis?
b.
How
does
my
agency
report
the
use
of
standards
in
procurements
on
a
transaction
basis?

Agency
Responsibilities
13.
What
Are
The
Responsibilities
Of
The
Secretary
Of
Commerce?
14.
What
Are
The
Responsibilities
Of
The
Heads
Of
Agencies?
15.
What
Are
The
Responsibilities
Of
Agency
Standards
Executives?

Supplementary
Information
16.
When
Will
This
Circular
Be
Reviewed?
17.
What
Is
The
Legal
Effect
Of
This
Circular?
18.
Do
You
Have
Further
Questions?

Background
1.
What
Is
The
Purpose
Of
This
Circular?
This
Circular
establishes
policies
to
improve
the
internal
management
of
the
Executive
Branch.
Consistent
with
Section
12(
d)
of
Pub.
L.
104
 
113,
the
``
National
Technology
Transfer
and
Advancement
Act
of
1995''
(
hereinafter
``
the
Act''),
this
Circular
directs
agencies
to
use
voluntary
consensus
standards
in
lieu
of
government­
unique
standards
except
where
inconsistent
with
law
or
otherwise
impractical.
It
also
provides
guidance
for
agencies
participating
in
voluntary
consensus
standards
bodies
and
describes
procedures
for
satisfying
8554
Federal
Register
/
Vol.
63,
No.
33
/
Thursday,
February
19,
1998
/
Notices
the
reporting
requirements
in
the
Act.
The
policies
in
this
Circular
are
intended
to
reduce
to
a
minimum
the
reliance
by
agencies
on
governmentunique
standards.
These
policies
do
not
create
the
bases
for
discrimination
in
agency
procurement
or
regulatory
activities
among
standards
developed
in
the
private
sector,
whether
or
not
they
are
developed
by
voluntary
consensus
standards
bodies.
Consistent
with
Section
12(
b)
of
the
Act,
this
Circular
directs
the
Secretary
of
Commerce
to
issue
guidance
to
the
agencies
in
order
to
coordinate
conformity
assessment
activities.
This
Circular
replaces
OMB
Circular
No.
A
 
119,
dated
October
20,
1993.
2.
What
Are
The
Goals
Of
The
Government
In
Using
Voluntary
Consensus
Standards?
Many
voluntary
consensus
standards
are
appropriate
or
adaptable
for
the
Government's
purposes.
The
use
of
such
standards,
whenever
practicable
and
appropriate,
is
intended
to
achieve
the
following
goals:
a.
Eliminate
the
cost
to
the
Government
of
developing
its
own
standards
and
decrease
the
cost
of
goods
procured
and
the
burden
of
complying
with
agency
regulation.
b.
Provide
incentives
and
opportunities
to
establish
standards
that
serve
national
needs.
c.
Encourage
long­
term
growth
for
U.
S.
enterprises
and
promote
efficiency
and
economic
competition
through
harmonization
of
standards.
d.
Further
the
policy
of
reliance
upon
the
private
sector
to
supply
Government
needs
for
goods
and
services.

Definitions
of
Standards
3.
What
Is
A
Standard?
a.
The
term
standard,
or
technical
standard
as
cited
in
the
Act,
includes
all
of
the
following:
(
1)
Common
and
repeated
use
of
rules,
conditions,
guidelines
or
characteristics
for
products
or
related
processes
and
production
methods,
and
related
management
systems
practices.
(
2)
The
definition
of
terms;
classification
of
components;
delineation
of
procedures;
specification
of
dimensions,
materials,
performance,
designs,
or
operations;
measurement
of
quality
and
quantity
in
describing
materials,
processes,
products,
systems,
services,
or
practices;
test
methods
and
sampling
procedures;
or
descriptions
of
fit
and
measurements
of
size
or
strength.
b.
The
term
standard
does
not
include
the
following:
(
1)
Professional
standards
of
personal
conduct.
(
2)
Institutional
codes
of
ethics.
c.
Performance
standard
is
a
standard
as
defined
above
that
states
requirements
in
terms
of
required
results
with
criteria
for
verifying
compliance
but
without
stating
the
methods
for
achieving
required
results.
A
performance
standard
may
define
the
functional
requirements
for
the
item,
operational
requirements,
and/
or
interface
and
interchangeability
characteristics.
A
performance
standard
may
be
viewed
in
juxtaposition
to
a
prescriptive
standard
which
may
specify
design
requirements,
such
as
materials
to
be
used,
how
a
requirement
is
to
be
achieved,
or
how
an
item
is
to
be
fabricated
or
constructed.
d.
Non­
government
standard
is
a
standard
as
defined
above
that
is
in
the
form
of
a
standardization
document
developed
by
a
private
sector
association,
organization
or
technical
society
which
plans,
develops,
establishes
or
coordinates
standards,
specifications,
handbooks,
or
related
documents.
4.
What
Are
Voluntary,
Consensus
Standards?
a.
For
purposes
of
this
policy,
voluntary
consensus
standards
are
standards
developed
or
adopted
by
voluntary
consensus
standards
bodies,
both
domestic
and
international.
These
standards
include
provisions
requiring
that
owners
of
relevant
intellectual
property
have
agreed
to
make
that
intellectual
property
available
on
a
nondiscriminatory
royalty­
free
or
reasonable
royalty
basis
to
all
interested
parties.
For
purposes
of
this
Circular,
``
technical
standards
that
are
developed
or
adopted
by
voluntary
consensus
standard
bodies''
is
an
equivalent
term.
(
1)
Voluntary
consensus
standards
bodies
are
domestic
or
international
organizations
which
plan,
develop,
establish,
or
coordinate
voluntary
consensus
standards
using
agreed­
upon
procedures.
For
purposes
of
this
Circular,
``
voluntary,
private
sector,
consensus
standards
bodies,''
as
cited
in
Act,
is
an
equivalent
term.
The
Act
and
the
Circular
encourage
the
participation
of
federal
representatives
in
these
bodies
to
increase
the
likelihood
that
the
standards
they
develop
will
meet
both
public
and
private
sector
needs.
A
voluntary
consensus
standards
body
is
defined
by
the
following
attributes:
(
i)
Openness.
(
ii)
Balance
of
interest.
(
iii)
Due
process.
(
vi)
An
appeals
process.
(
v)
Consensus,
which
is
defined
as
general
agreement,
but
not
necessarily
unanimity,
and
includes
a
process
for
attempting
to
resolve
objections
by
interested
parties,
as
long
as
all
comments
have
been
fairly
considered,
each
objector
is
advised
of
the
disposition
of
his
or
her
objection(
s)
and
the
reasons
why,
and
the
consensus
body
members
are
given
an
opportunity
to
change
their
votes
after
reviewing
the
comments.
b.
Other
types
of
standards,
which
are
distinct
from
voluntary
consensus
standards,
are
the
following:
(
1)
``
Non­
consensus
standards,''
``
Industry
standards,''
``
Company
standards,''
or
``
de
facto
standards,''
which
are
developed
in
the
private
sector
but
not
in
the
full
consensus
process.
(
2)
``
Government­
unique
standards,''
which
are
developed
by
the
government
for
its
own
uses.
(
3)
Standards
mandated
by
law,
such
as
those
contained
in
the
United
States
Pharmacopeia
and
the
National
Formulary,
as
referenced
in
21
U.
S.
C.
351.

Policy
5.
Who
Does
This
Policy
Apply
To?
This
Circular
applies
to
all
agencies
and
agency
employees
who
use
standards
and
participate
in
voluntary
consensus
standards
activities,
domestic
and
international,
except
for
activities
carried
out
pursuant
to
treaties.
``
Agency''
means
any
executive
department,
independent
commission,
board,
bureau,
office,
agency,
Government­
owned
or
controlled
corporation
or
other
establishment
of
the
Federal
Government.
It
also
includes
any
regulatory
commission
or
board,
except
for
independent
regulatory
commissions
insofar
as
they
are
subject
to
separate
statutory
requirements
regarding
the
use
of
voluntary
consensus
standards.
It
does
not
include
the
legislative
or
judicial
branches
of
the
Federal
Government.
6.
What
Is
The
Policy
For
Federal
Use
Of
Standards?
All
federal
agencies
must
use
voluntary
consensus
standards
in
lieu
of
government­
unique
standards
in
their
procurement
and
regulatory
activities,
except
where
inconsistent
with
law
or
otherwise
impractical.
In
these
circumstances,
your
agency
must
submit
a
report
describing
the
reason(
s)
for
its
use
of
government­
unique
standards
in
lieu
of
voluntary
consensus
standards
to
the
Office
of
Management
and
Budget
(
OMB)
through
the
National
Institute
of
Standards
and
Technology
(
NIST).
a.
When
must
my
agency
use
voluntary
consensus
standards?
Your
agency
must
use
voluntary
consensus
standards,
both
domestic
and
international,
in
its
regulatory
and
procurement
activities
in
lieu
of
government­
unique
standards,
unless
use
of
such
standards
would
be
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/
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19,
1998
/
Notices
inconsistent
with
applicable
law
or
otherwise
impractical.
In
all
cases,
your
agency
has
the
discretion
to
decline
to
use
existing
voluntary
consensus
standards
if
your
agency
determines
that
such
standards
are
inconsistent
with
applicable
law
or
otherwise
impractical.
(
1)
``
Use''
means
incorporation
of
a
standard
in
whole,
in
part,
or
by
reference
for
procurement
purposes,
and
the
inclusion
of
a
standard
in
whole,
in
part,
or
by
reference
in
regulation(
s).
(
2)
``
Impractical''
includes
circumstances
in
which
such
use
would
fail
to
serve
the
agency's
program
needs;
would
be
infeasible;
would
be
inadequate,
ineffectual,
inefficient,
or
inconsistent
with
agency
mission;
or
would
impose
more
burdens,
or
would
be
less
useful,
than
the
use
of
another
standard.
b.
What
must
my
agency
do
when
such
use
is
determined
by
my
agency
to
be
inconsistent
with
applicable
law
or
otherwise
impractical?
The
head
of
your
agency
must
transmit
to
the
Office
of
Management
and
Budget
(
OMB),
through
the
National
Institute
of
Standards
and
Technology
(
NIST),
an
explanation
of
the
reason(
s)
for
using
government­
unique
standards
in
lieu
of
voluntary
consensus
standards.
For
more
information
on
reporting,
see
section
9.
c.
How
does
this
policy
affect
my
agency's
regulatory
authorities
and
responsibilities?
This
policy
does
not
preempt
or
restrict
agencies'
authorities
and
responsibilities
to
make
regulatory
decisions
authorized
by
statute.
Such
regulatory
authorities
and
responsibilities
include
determining
the
level
of
acceptable
risk;
setting
the
level
of
protection;
and
balancing
risk,
cost,
and
availability
of
technology
in
establishing
regulatory
standards.
However,
to
determine
whether
established
regulatory
limits
or
targets
have
been
met,
agencies
should
use
voluntary
consensus
standards
for
test
methods,
sampling
procedures,
or
protocols.
d.
How
does
this
policy
affect
my
agency's
procurement
authority?
This
policy
does
not
preempt
or
restrict
agencies'
authorities
and
responsibilities
to
identify
the
capabilities
that
they
need
to
obtain
through
procurements.
Rather,
this
policy
limits
an
agency's
authority
to
pursue
an
identified
capability
through
reliance
on
a
government­
unique
standard
when
a
voluntary
consensus
standard
exists
(
see
Section
6a).
e.
What
are
the
goals
of
agency
use
of
voluntary
consensus
standards?
Agencies
should
recognize
the
positive
contribution
of
standards
development
and
related
activities.
When
properly
conducted,
standards
development
can
increase
productivity
and
efficiency
in
Government
and
industry,
expand
opportunities
for
international
trade,
conserve
resources,
improve
health
and
safety,
and
protect
the
environment.
f.
What
considerations
should
my
agency
make
when
it
is
considering
using
a
standard?
When
considering
using
a
standard,
your
agency
should
take
full
account
of
the
effect
of
using
the
standard
on
the
economy,
and
of
applicable
federal
laws
and
policies,
including
laws
and
regulations
relating
to
antitrust,
national
security,
small
business,
product
safety,
environment,
metrication,
technology
development,
and
conflicts
of
interest.
Your
agency
should
also
recognize
that
use
of
standards,
if
improperly
conducted,
can
suppress
free
and
fair
competition;
impede
innovation
and
technical
progress;
exclude
safer
or
less
expensive
products;
or
otherwise
adversely
affect
trade,
commerce,
health,
or
safety.
If
your
agency
is
proposing
to
incorporate
a
standard
into
a
proposed
or
final
rulemaking,
your
agency
must
comply
with
the
``
Principles
of
Regulation''
(
enumerated
in
Section
1(
b))
and
with
the
other
analytical
requirements
of
Executive
Order
12866,
``
Regulatory
Planning
and
Review.''
g.
Does
this
policy
establish
a
preference
between
consensus
and
nonconsensus
standards
that
are
developed
in
the
private
sector?
This
policy
does
not
establish
a
preference
among
standards
developed
in
the
private
sector.
Specifically,
agencies
that
promulgate
regulations
referencing
non­
consensus
standards
developed
in
the
private
sector
are
not
required
to
report
on
these
actions,
and
agencies
that
procure
products
or
services
based
on
non­
consensus
standards
are
not
required
to
report
on
such
procurements.
For
example,
this
policy
allows
agencies
to
select
a
nonconsensus
standard
developed
in
the
private
sector
as
a
means
of
establishing
testing
methods
in
a
regulation
and
to
choose
among
commercial­
off­
the­
shelf
products,
regardless
of
whether
the
underlying
standards
are
developed
by
voluntary
consensus
standards
bodies
or
not.
h.
Does
this
policy
establish
a
preference
between
domestic
and
international
voluntary
consensus
standards?
This
policy
does
not
establish
a
preference
between
domestic
and
international
voluntary
consensus
standards.
However,
in
the
interests
of
promoting
trade
and
implementing
the
provisions
of
international
treaty
agreements,
your
agency
should
consider
international
standards
in
procurement
and
regulatory
applications.
i.
Should
my
agency
give
preference
to
performance
standards?
In
using
voluntary
consensus
standards,
your
agency
should
give
preference
to
performance
standards
when
such
standards
may
reasonably
be
used
in
lieu
of
prescriptive
standards.
j.
How
should
my
agency
reference
voluntary
consensus
standards?
Your
agency
should
reference
voluntary
consensus
standards,
along
with
sources
of
availability,
in
appropriate
publications,
regulatory
orders,
and
related
internal
documents.
In
regulations,
the
reference
must
include
the
date
of
issuance.
For
all
other
uses,
your
agency
must
determine
the
most
appropriate
form
of
reference,
which
may
exclude
the
date
of
issuance
as
long
as
users
are
elsewhere
directed
to
the
latest
issue.
If
a
voluntary
standard
is
used
and
published
in
an
agency
document,
your
agency
must
observe
and
protect
the
rights
of
the
copyright
holder
and
any
other
similar
obligations.
k.
What
if
no
voluntary
consensus
standard
exists?
In
cases
where
no
voluntary
consensus
standards
exist,
an
agency
may
use
government­
unique
standards
(
in
addition
to
other
standards,
see
Section
6g)
and
is
not
required
to
file
a
report
on
its
use
of
government­
unique
standards.
As
explained
above
(
see
Section
6a),
an
agency
may
use
government­
unique
standards
in
lieu
of
voluntary
consensus
standards
if
the
use
of
such
standards
would
be
inconsistent
with
applicable
law
or
otherwise
impractical;
in
such
cases,
the
agency
must
file
a
report
under
Section
9a
regarding
its
use
of
government­
unique
standards.
l.
How
may
my
agency
identify
voluntary
consensus
standards?
Your
agency
may
identify
voluntary
consensus
standards
through
databases
of
standards
maintained
by
the
National
Institute
of
Standards
and
Technology
(
NIST),
or
by
other
organizations
including
voluntary
consensus
standards
bodies,
other
federal
agencies,
or
standards
publishing
companies.
7.
What
Is
The
Policy
For
Federal
Participation
In
Voluntary
Consensus
Standards
Bodies?
Agencies
must
consult
with
voluntary
consensus
standards
bodies,
both
domestic
and
international,
and
must
participate
with
such
bodies
in
the
development
of
voluntary
consensus
standards
when
consultation
and
participation
is
in
the
public
interest
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/
Notices
and
is
compatible
with
their
missions,
authorities,
priorities,
and
budget
resources.
a.
What
are
the
purposes
of
agency
participation?
Agency
representatives
should
participate
in
voluntary
consensus
standards
activities
in
order
to
accomplish
the
following
purposes:
(
1)
Eliminate
the
necessity
for
development
or
maintenance
of
separate
Government­
unique
standards.
(
2)
Further
such
national
goals
and
objectives
as
increased
use
of
the
metric
system
of
measurement;
use
of
environmentally
sound
and
energy
efficient
materials,
products,
systems,
services,
or
practices;
and
improvement
of
public
health
and
safety.
b.
What
are
the
general
principles
that
apply
to
agency
support?
Agency
support
provided
to
a
voluntary
consensus
standards
activity
must
be
limited
to
that
which
clearly
furthers
agency
and
departmental
missions,
authorities,
priorities,
and
is
consistent
with
budget
resources.
Agency
support
must
not
be
contingent
upon
the
outcome
of
the
standards
activity.
Normally,
the
total
amount
of
federal
support
should
be
no
greater
than
that
of
other
participants
in
that
activity,
except
when
it
is
in
the
direct
and
predominant
interest
of
the
Government
to
develop
or
revise
a
standard,
and
its
timely
development
or
revision
appears
unlikely
in
the
absence
of
such
support.
c.
What
forms
of
support
may
my
agency
provide?
The
form
of
agency
support,
may
include
the
following:
(
1)
Direct
financial
support;
e.
g.,
grants,
memberships,
and
contracts.
(
2)
Administrative
support;
e.
g.,
travel
costs,
hosting
of
meetings,
and
secretarial
functions.
(
3)
Technical
support;
e.
g.,
cooperative
testing
for
standards
evaluation
and
participation
of
agency
personnel
in
the
activities
of
voluntary
consensus
standards
bodies.
(
4)
Joint
planning
with
voluntary
consensus
standards
bodies
to
promote
the
identification
and
development
of
needed
standards.
(
5)
Participation
of
agency
personnel.
d.
Must
agency
participants
be
authorized?
Agency
employees
who,
at
Government
expense,
participate
in
standards
activities
of
voluntary
consensus
standards
bodies
on
behalf
of
the
agency
must
do
so
as
specifically
authorized
agency
representatives.
Agency
support
for,
and
participation
by
agency
personnel
in,
voluntary
consensus
standards
bodies
must
be
in
compliance
with
applicable
laws
and
regulations.
For
example,
agency
support
is
subject
to
legal
and
budgetary
authority
and
availability
of
funds.
Similarly,
participation
by
agency
employees
(
whether
or
not
on
behalf
of
the
agency)
in
the
activities
of
voluntary
consensus
standards
bodies
is
subject
to
the
laws
and
regulations
that
apply
to
participation
by
federal
employees
in
the
activities
of
outside
organizations.
While
we
anticipate
that
participation
in
a
committee
that
is
developing
a
standard
would
generally
not
raise
significant
issues,
participation
as
an
officer,
director,
or
trustee
of
an
organization
would
raise
more
significant
issues.
An
agency
should
involve
its
agency
ethics
officer,
as
appropriate,
before
authorizing
support
for
or
participation
in
a
voluntary
consensus
standards
body.
e.
Does
agency
participation
indicate
endorsement
of
any
decisions
reached
by
voluntary
consensus
standards
bodies?
Agency
participation
in
voluntary
consensus
standards
bodies
does
not
necessarily
connote
agency
agreement
with,
or
endorsement
of,
decisions
reached
by
such
organizations.
f.
Do
agency
representatives
participate
equally
with
other
members?
Agency
representatives
serving
as
members
of
voluntary
consensus
standards
bodies
should
participate
actively
and
on
an
equal
basis
with
other
members,
consistent
with
the
procedures
of
those
bodies,
particularly
in
matters
such
as
establishing
priorities,
developing
procedures
for
preparing,
reviewing,
and
approving
standards,
and
developing
or
adopting
new
standards.
Active
participation
includes
full
involvement
in
discussions
and
technical
debates,
registering
of
opinions
and,
if
selected,
serving
as
chairpersons
or
in
other
official
capacities.
Agency
representatives
may
vote,
in
accordance
with
the
procedures
of
the
voluntary
consensus
standards
body,
at
each
stage
of
the
standards
development
process
unless
prohibited
from
doing
so
by
law
or
their
agencies.
g.
Are
there
any
limitations
on
participation
by
agency
representatives?
In
order
to
maintain
the
independence
of
voluntary
consensus
standards
bodies,
agency
representatives
must
refrain
from
involvement
in
the
internal
management
of
such
organizations
(
e.
g.,
selection
of
salaried
officers
and
employees,
establishment
of
staff
salaries,
and
administrative
policies).
Agency
representatives
must
not
dominate
such
bodies,
and
in
any
case
are
bound
by
voluntary
consensus
standards
bodies'
rules
and
procedures,
including
those
regarding
domination
of
proceedings
by
any
individual.
Regardless,
such
agency
employees
must
avoid
the
practice
or
the
appearance
of
undue
influence
relating
to
their
agency
representation
and
activities
in
voluntary
consensus
standards
bodies.
h.
Are
there
any
limits
on
the
number
of
federal
participants
in
voluntary
consensus
standards
bodies?
The
number
of
individual
agency
participants
in
a
given
voluntary
standards
activity
should
be
kept
to
the
minimum
required
for
effective
representation
of
the
various
program,
technical,
or
other
concerns
of
federal
agencies.
i.
Is
there
anything
else
agency
representatives
should
know?
This
Circular
does
not
provide
guidance
concerning
the
internal
operating
procedures
that
may
be
applicable
to
voluntary
consensus
standards
bodies
because
of
their
relationships
to
agencies
under
this
Circular.
Agencies
should,
however,
carefully
consider
what
laws
or
rules
may
apply
in
a
particular
instance
because
of
these
relationships.
For
example,
these
relationships
may
involve
the
Federal
Advisory
Committee
Act,
as
amended
(
5
U.
S.
C.
App.
I),
or
a
provision
of
an
authorizing
statute
for
a
particular
agency.
j.
What
if
a
voluntary
consensus
standards
body
is
likely
to
develop
an
acceptable,
needed
standard
in
a
timely
fashion?
If
a
voluntary
consensus
standards
body
is
in
the
process
of
developing
or
adopting
a
voluntary
consensus
standard
that
would
likely
be
lawful
and
practical
for
an
agency
to
use,
and
would
likely
be
developed
or
adopted
on
a
timely
basis,
an
agency
should
not
be
developing
its
own
governmentunique
standard
and
instead
should
be
participating
in
the
activities
of
the
voluntary
consensus
standards
body.
8.
What
Is
The
Policy
On
Conformity
Assessment?
Section
12(
b)
of
the
Act
requires
NIST
to
coordinate
Federal,
State,
and
local
standards
activities
and
conformity
assessment
activities
with
private
sector
standards
activities
and
conformity
assessment
activities,
with
the
goal
of
eliminating
unnecessary
duplication
and
complexity
in
the
development
and
promulgation
of
conformity
assessment
requirements
and
measures.
To
ensure
effective
coordination,
the
Secretary
of
Commerce
must
issue
guidance
to
the
agencies.

Management
and
Reporting
of
Standards
Use
9.
What
Is
My
Agency
Required
to
Report?
8557
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Register
/
Vol.
63,
No.
33
/
Thursday,
February
19,
1998
/
Notices
a.
As
required
by
the
Act,
your
agency
must
report
to
NIST,
no
later
than
December
31
of
each
year,
the
decisions
by
your
agency
in
the
previous
fiscal
year
to
use
government­
unique
standards
in
lieu
of
voluntary
consensus
standards.
If
no
voluntary
consensus
standard
exists,
your
agency
does
not
need
to
report
its
use
of
governmentunique
standards.
(
In
addition,
an
agency
is
not
required
to
report
on
its
use
of
other
standards.
See
Section
6g.)
Your
agency
must
include
an
explanation
of
the
reason(
s)
why
use
of
such
voluntary
consensus
standard
would
be
inconsistent
with
applicable
law
or
otherwise
impractical,
as
described
in
Sections
11b(
2),
12a(
3),
and
12b(
2)
of
this
Circular.
Your
agency
must
report
in
accordance
with
format
instructions
issued
by
NIST.
b.
Your
agency
must
report
to
NIST,
no
later
than
December
31
of
each
year,
information
on
the
nature
and
extent
of
agency
participation
in
the
development
and
use
of
voluntary
consensus
standards
from
the
previous
fiscal
year.
Your
agency
must
report
in
accordance
with
format
instructions
issued
by
NIST.
Such
reporting
must
include
the
following:
(
1)
The
number
of
voluntary
consensus
standards
bodies
in
which
there
is
agency
participation,
as
well
as
the
number
of
agency
employees
participating.
(
2)
The
number
of
voluntary
consensus
standards
the
agency
has
used
since
the
last
report,
based
on
the
procedures
set
forth
in
sections
11
and
12
of
this
Circular.
(
3)
Identification
of
voluntary
consensus
standards
that
have
been
substituted
for
government­
unique
standards
as
a
result
of
an
agency
review
under
section
15b(
7)
of
this
Circular.
(
4)
An
evaluation
of
the
effectiveness
of
this
policy
and
recommendations
for
any
changes.
c.
No
later
than
the
following
January
31,
NIST
must
transmit
to
OMB
a
summary
report
of
the
information
received.
10.
How
Does
My
Agency
Manage
And
Report
Its
Development
and
Use
Of
Standards?
Your
agency
must
establish
a
process
to
identify,
manage,
and
review
your
agency's
development
and
use
of
standards.
At
minimum,
your
agency
must
have
the
ability
to
(
1)
report
to
OMB
through
NIST
on
the
agency's
use
of
government­
unique
standards
in
lieu
of
voluntary
consensus
standards,
along
with
an
explanation
of
the
reasons
for
such
non­
usage,
as
described
in
section
9a,
and
(
2)
report
on
your
agency's
participation
in
the
development
and
use
of
voluntary
consensus
standards,
as
described
in
section
9b.
This
policy
establishes
two
ways,
category
based
reporting
and
transaction
based
reporting,
for
agencies
to
manage
and
report
their
use
of
standards.
Your
agency
must
report
all
uses
of
standards
in
one
or
both
ways.
11.
What
Are
The
Procedures
For
Reporting
My
Agency's
Use
Of
Standards
In
Regulations?
Your
agency
should
use
transaction
based
reporting
if
your
agency
issues
regulations
that
use
or
reference
standards.
If
your
agency
is
issuing
or
revising
a
regulation
that
contains
a
standard,
your
agency
must
follow
these
procedures:
a.
Publish
a
request
for
comment
within
the
preamble
of
a
Notice
of
Proposed
Rulemaking
(
NPRM)
or
Interim
Final
Rule
(
IFR).
Such
request
must
provide
the
appropriate
information,
as
follows:
(
1)
When
your
agency
is
proposing
to
use
a
voluntary
consensus
standard,
provide
a
statement
which
identifies
such
standard.
(
2)
When
your
agency
is
proposing
to
use
a
government­
unique
standard
in
lieu
of
a
voluntary
consensus
standard,
provide
a
statement
which
identifies
such
standards
and
provides
a
preliminary
explanation
for
the
proposed
use
of
a
government­
unique
standard
in
lieu
of
a
voluntary
consensus
standard.
(
3)
When
your
agency
is
proposing
to
use
a
government­
unique
standard,
and
no
voluntary
consensus
standard
has
been
identified,
a
statement
to
that
effect
and
an
invitation
to
identify
any
such
standard
and
to
explain
why
such
standard
should
be
used.
b.
Publish
a
discussion
in
the
preamble
of
a
Final
Rulemaking
that
restates
the
statement
in
the
NPRM
or
IFR,
acknowledges
and
summarizes
any
comments
received
and
responds
to
them,
and
explains
the
agency's
final
decision.
This
discussion
must
provide
the
appropriate
information,
as
follows:
(
1)
When
a
voluntary
consensus
standard
is
being
used,
provide
a
statement
that
identifies
such
standard
and
any
alternative
voluntary
consensus
standards
which
have
been
identified.
(
2)
When
a
government­
unique
standard
is
being
used
in
lieu
of
a
voluntary
consensus
standard,
provide
a
statement
that
identifies
the
standards
and
explains
why
using
the
voluntary
consensus
standard
would
be
inconsistent
with
applicable
law
or
otherwise
impractical.
Such
explanation
must
be
transmitted
in
accordance
with
the
requirements
of
Section
9a.
(
3)
When
a
government­
unique
standard
is
being
used,
and
no
voluntary
consensus
standard
has
been
identified,
provide
a
statement
to
that
effect.
12.
What
Are
The
Procedures
For
Reporting
My
Agency's
Use
Of
Standards
In
Procurements?
To
identify,
manage,
and
review
the
standards
used
in
your
agency's
procurements,
your
agency
must
either
report
on
a
categorical
basis
or
on
a
transaction
basis.
a.
How
does
my
agency
report
the
use
of
standards
in
procurements
on
a
categorical
basis?
Your
agency
must
report
on
a
category
basis
when
your
agency
identifies,
manages,
and
reviews
the
use
of
standards
by
group
or
category.
Category
based
reporting
is
especially
useful
when
your
agency
either
conducts
large
procurements
or
large
numbers
of
procurements
using
government­
unique
standards,
or
is
involved
in
long­
term
procurement
contracts
which
require
replacement
parts
based
on
governmentunique
standards.
To
report
use
of
government­
unique
standards
on
a
categorical
basis,
your
agency
must:
(
1)
Maintain
a
centralized
standards
management
system
that
identifies
how
your
agency
uses
both
governmentunique
and
voluntary
consensus
standards.
(
2)
Systematically
review
your
agency's
use
of
government­
unique
standards
for
conversion
to
voluntary
consensus
standards.
(
3)
Maintain
records
on
the
groups
or
categories
in
which
your
agency
uses
government­
unique
standards
in
lieu
of
voluntary
consensus
standards,
including
an
explanation
of
the
reasons
for
such
use,
which
must
be
transmitted
according
to
Section
9a.
(
4)
Enable
potential
offerors
to
suggest
voluntary
consensus
standards
that
can
replace
government­
unique
standards.
b.
How
does
my
agency
report
the
use
of
standards
in
procurements
on
a
transaction
basis?
Your
agency
should
report
on
a
transaction
basis
when
your
agency
identifies,
manages,
and
reviews
the
use
of
standards
on
a
transaction
basis
rather
than
a
category
basis.
Transaction
based
reporting
is
especially
useful
when
your
agency
conducts
procurement
mostly
through
commercial
products
and
services,
but
is
occasionally
involved
in
a
procurement
involving
governmentunique
standards.
To
report
use
of
government­
unique
standards
on
a
transaction
basis,
your
agency
must
follow
the
following
procedures:
(
1)
In
each
solicitation
which
references
government­
unique
standards,
the
solicitation
must:
(
i)
Identify
such
standards.
8558
Federal
Register
/
Vol.
63,
No.
33
/
Thursday,
February
19,
1998
/
Notices
(
ii)
Provide
potential
offerors
an
opportunity
to
suggest
alternative
voluntary
consensus
standards
that
meet
the
agency's
requirements.
(
2)
If
such
suggestions
are
made
and
the
agency
decides
to
use
governmentunique
standards
in
lieu
of
voluntary
consensus
standards,
the
agency
must
explain
in
its
report
to
OMB
as
described
in
Section
9a
why
using
such
voluntary
consensus
standards
is
inconsistent
with
applicable
law
or
otherwise
impractical.
c.
For
those
solicitations
that
are
for
commercial­
off­
the­
shelf
products
(
COTS),
or
for
products
or
services
that
rely
on
voluntary
consensus
standards
or
non­
consensus
standards
developed
in
the
private
sector,
or
for
products
that
otherwise
do
not
rely
on
governmentunique
standards,
the
requirements
in
this
section
do
not
apply.

Agency
Responsibilities
13.
What
Are
The
Responsibilities
Of
The
Secretary
Of
Commerce?
The
Secretary
of
Commerce:
a.
Coordinates
and
fosters
executive
branch
implementation
of
this
Circular
and,
as
appropriate,
provides
administrative
guidance
to
assist
agencies
in
implementing
this
Circular
including
guidance
on
identifying
voluntary
consensus
standards
bodies
and
voluntary
consensus
standards.
b.
Sponsors
and
supports
the
Interagency
Committee
on
Standards
Policy
(
ICSP),
chaired
by
the
National
Institute
of
Standards
and
Technology,
which
considers
agency
views
and
advises
the
Secretary
and
agency
heads
on
the
Circular.
c.
Reports
to
the
Director
of
OMB
concerning
the
implementation
of
the
policy
provisions
of
this
Circular.
d.
Establishes
procedures
for
agencies
to
use
when
developing
directories
described
in
Section
15b(
5)
and
establish
procedures
to
make
these
directories
available
to
the
public.
e.
Issues
guidance
to
the
agencies
to
improve
coordination
on
conformity
assessment
in
accordance
with
section
8.
14.
What
Are
The
Responsibilities
Of
The
Heads
Of
Agencies?
The
Heads
of
Agencies:
a.
Implement
the
policies
of
this
Circular
in
accordance
with
procedures
described.
b.
Ensure
agency
compliance
with
the
policies
of
the
Circular.
c.
In
the
case
of
an
agency
with
significant
interest
in
the
use
of
standards,
designate
a
senior
level
official
as
the
Standards
Executive
who
will
be
responsible
for
the
agency's
implementation
of
this
Circular
and
who
will
represent
the
agency
on
the
ICSP.
d.
Transmit
the
annual
report
prepared
by
the
Agency
Standards
Executive
as
described
in
Sections
9
and
15b(
6).
15.
What
Are
The
Responsibilities
Of
Agency
Standards
Executives?
An
Agency
Standards
Executive:
a.
Promotes
the
following
goals:
(
1)
Effective
use
of
agency
resources
and
participation.
(
2)
The
development
of
agency
positions
that
are
in
the
public
interest
and
that
do
not
conflict
with
each
other.
(
3)
The
development
of
agency
positions
that
are
consistent
with
administration
policy.
(
4)
The
development
of
agency
technical
and
policy
positions
that
are
clearly
defined
and
known
in
advance
to
all
federal
participants
on
a
given
committee.
b.
Coordinates
his
or
her
agency's
participation
in
voluntary
consensus
standards
bodies
by:
(
1)
Establishing
procedures
to
ensure
that
agency
representatives
who
participate
in
voluntary
consensus
standards
bodies
will,
to
the
extent
possible,
ascertain
the
views
of
the
agency
on
matters
of
paramount
interest
and
will,
at
a
minimum,
express
views
that
are
not
inconsistent
or
in
conflict
with
established
agency
views.
(
2)
To
the
extent
possible,
ensuring
that
the
agency's
participation
in
voluntary
consensus
standards
bodies
is
consistent
with
agency
missions,
authorities,
priorities,
and
budget
resources.
(
3)
Ensuring,
when
two
or
more
agencies
participate
in
a
given
voluntary
consensus
standards
activity,
that
they
coordinate
their
views
on
matters
of
paramount
importance
so
as
to
present,
whenever
feasible,
a
single,
unified
position
and,
where
not
feasible,
a
mutual
recognition
of
differences.
(
4)
Cooperating
with
the
Secretary
in
carrying
out
his
or
her
responsibilities
under
this
Circular.
(
5)
Consulting
with
the
Secretary,
as
necessary,
in
the
development
and
issuance
of
internal
agency
procedures
and
guidance
implementing
this
Circular,
including
the
development
and
implementation
of
an
agency­
wide
directory
identifying
agency
employees
participating
in
voluntary
consensus
standards
bodies
and
the
identification
of
voluntary
consensus
standards
bodies.
(
6)
Preparing,
as
described
in
Section
9,
a
report
on
uses
of
governmentunique
standards
in
lieu
of
voluntary
consensus
standards
and
a
report
on
the
status
of
agency
standards
policy
activities.
(
7)
Establishing
a
process
for
ongoing
review
of
the
agency's
use
of
standards
for
purposes
of
updating
such
use.
(
8)
Coordinating
with
appropriate
agency
offices
(
e.
g.,
budget
and
legal
offices)
to
ensure
that
effective
processes
exist
for
the
review
of
proposed
agency
support
for,
and
participation
in,
voluntary
consensus
standards
bodies,
so
that
agency
support
and
participation
will
comply
with
applicable
laws
and
regulations.

Supplementary
Information
16.
When
Will
This
Circular
Be
Reviewed?
This
Circular
will
be
reviewed
for
effectiveness
by
the
OMB
three
years
from
the
date
of
issuance.
17.
What
Is
The
Legal
Effect
Of
This
Circular?
Authority
for
this
Circular
is
based
on
31
U.
S.
C.
1111,
which
gives
OMB
broad
authority
to
establish
policies
for
the
improved
management
of
the
Executive
Branch.
This
Circular
is
intended
to
implement
Section
12(
d)
of
Public
Law
104
 
113
and
to
establish
policies
that
will
improve
the
internal
management
of
the
Executive
Branch.
This
Circular
is
not
intended
to
create
delay
in
the
administrative
process,
provide
new
grounds
for
judicial
review,
or
create
new
rights
or
benefits,
substantive
or
procedural,
enforceable
at
law
or
equity
by
a
party
against
the
United
States,
its
agencies
or
instrumentalities,
or
its
officers
or
employees.
18.
Do
You
Have
Further
Questions?
For
information
concerning
this
Circular,
contact
the
Office
of
Management
and
Budget,
Office
of
Information
and
Regulatory
Affairs:
Telephone
202/
395
 
3785.

[
FR
Doc.
98
 
4177
Filed
2
 
18
 
98;
8:
45
am]

BILLING
CODE
3110
 
01
 
P