Document ID: EPA-HQ-OAR-2006-0525-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-07-17T04:00Z

1
INFORMATION
COLLECTION
REQUEST
(
ICR)
Part
A
of
the
Supporting
Statement
(
Draft
­
June
2006)
1.
IDENTIFICATION
OF
THE
INFORMATION
COLLECTION
1(
a)
Title:
Registration
of
Fuels
and
Fuel
Additives
­
Health­
Effects
Research
Requirements
for
Manufacturers
(
40
CFR
79
­
Subpart
F)
EPA
ICR
Number
1696.05,
OMB
Control
Number
2060­
0297
1(
b)
Abstract
In
accordance
with
the
regulations
at
40
CFR
79,
Subparts
A,
B,
C,
D
and
F
(
there
is
no
Subpart
E),
Registration
of
Fuels
and
Fuel
Additives,
manufacturers
of
(
1)
motor
vehicle
gasoline,
(
2)
motor
vehicle
diesel
fuel,
and
(
3)
additives
for
those
fuels,
are
required
to
have
their
products
registered
by
the
Environmental
Protection
Agency
(
EPA)
prior
to
their
introduction
into
commerce.
Registration
involves
providing
(
1)
a
chemical
description
of
the
fuel
or
additive,
(
2)
certain
technical
and
marketing
information,
and
(
3)
certain
health­
effects
information.
Periodic
reports
on
production
and
related
information
are
required.
Subpart
F
requires
the
conduct
of
health­
effects
research.
This
ICR
addresses
the
information
collection
requirements
of
that
research.
The
information
collection
requirements
of
Subparts
A
through
D,
and
the
supplemental
notification
requirement
of
Subpart
F
(
indicating
how
the
manufacturer
plans
to
satisfy
the
research
requirements,
or
qualifies
for
an
exemption)
are
covered
by
a
separate
ICR
(
EPA
ICR
Number
309.10,
OMB
Control
Number
2060­
0150,
expiration
date:
3­
31­
2007).

The
program
is
operated
by
the
Transportation
and
Regional
Programs
Division,
Office
of
Transportation
and
Air
Quality,
Office
of
Air
and
Radiation.
The
information
developed
by
the
health­
effects
research
will
be
used
to
identify
products
whose
evaporative
or
exhaust
emissions
pose
a
particular
threat
to
public
health,
thus
meriting
further
investigation
and/
or
regulation.
Manufacturers
of
similar
products
are
allowed
to
group
in
order
to
share
the
research
costs.
Several
groups,
also
known
as
consortiums,
have
been
formed.
The
largest
consortium,
organized
by
the
American
Petroleum
Institute
(
API),
represents
most
of
the
manufacturers
of
conventional
gasolines,
diesel
fuels,
and
additives.
The
regulations
define
the
fuel/
additive
categories
for
which
the
research
is
required.
There
are
three
tiers
of
requirements.
Tier
1
requires
an
emissions
characterization
(
combustion,
and
in
certain
instances,
evaporative)
and
a
literature
search
over
the
past
30
years
for
health­
effects
information
on
those
emissions.
Tier
2
(
also
known
as
standard
Tier
2)
requires
short­
term
inhalation
exposures
of
laboratory
animals
to
emissions
(
combustion,
and
if
required
under
Tier
1,
evaporative)
to
screen
for
adverse
health
effects.
The
EPA
has
the
authority
to
require
"
Alternative
Tier
2"
testing
if
there
is
a
reasonable
basis
to
conclude
that
such
testing
is
more
appropriate.
The
EPA
reached
that
conclusion
with
respect
to
gasoline
and
gasoline­
oxygenate
blends.
The
API
consortium
was
notified
of
the
proposed
alternative
requirements
in
1997.
After
public
review
and
comment,
and
discussions
with
API,
the
alternative
requirements
were
finalized
and
API
notified
in
1998.
Similar
situations
existed
for
a
manganese
gasoline
additive
known
a
MMT,
manufactured
by
the
Ethyl
Corporation
(
now
Afton
Chemical
Corporation),
and
a
blend
of
diesel
fuel
and
water,
known
as
PuriNOx,
manufactured
by
the
Lubrizol
Corporation.
Tier
3
provides
for
follow­
up
research.
2
Tier
3
can
be
required
when
uncertainties
as
to
the
significance
of
observed
health
effects,
welfare
effects,
and/
or
emissions
exposures
from
a
fuel
or
fuel/
additive
mixture
interfere
with
EPA's
ability
to
make
reasonable
estimates
of
the
potential
risks
posed
by
the
emissions
from
such
products.

There
are
approximately
300
fuel
manufacturers,
700
additive
manufacturers,
500
registered
fuels,
and
5700
registered
additives.
These
numbers
change
daily.

2.
NEED
FOR
AND
USE
OF
THE
COLLECTION
2(
a)
Need/
Authority
for
the
Collection
Motor
vehicles
comprise
a
major
source
of
air
pollution
in
urban
areas,
and
account
for
about
half
the
toxic
air
emissions
in
the
United
States.
Congress
demonstrated
its
strong
concern
for
the
protection
of
public
health
by
providing
broad
legislative
authority
to
monitor
and
regulate
fuels,
fuel
additives,
and
their
emissions.
This
registration
program
was
established
by
the
Air
Quality
Act
of
1967,
carried
forward
into
the
Clean
Air
Act
(
Act)
of
1970,
and
strengthened
in
the
Act's
1977
and
1990
reauthorizations.

Section
211(
a)
of
the
Act
provides
EPA
with
the
authority
to
designate,
by
regulation,
any
mobile
source
fuel
or
additive
for
registration.
Any
fuel
or
additive
used
to
such
an
extent
that
there
is,
or
would
be,
significant
public
emissions
exposure,
is
an
appropriate
candidate.
Once
designated,
it
may
not
be
introduced
into
commerce
until
it
has
been
registered
by
EPA.
Section
211(
b)
requires,
for
the
purpose
of
registration,
that
the
manufacturer
provide
certain
compositional
and
related
information.
It
provides
EPA
with
the
authority
to
require
healtheffects
testing
and
the
submittal
of
health­
effects
data
and
related
data.
Section
211(
e),
a
1977
amendment,
made
the
health­
effects
research
requirements
mandatory.
The
original
regulations
were
promulgated
by
the
Department
of
Health,
Education,
and
Welfare
in
1970
and
transferred
to
the
EPA
shortly
thereafter.
They
ultimately
resided
at
40
CFR
79
and
were
revised
in
1975,
1976,
1978,
1994,
1996,
1997
and
1998
.
Due
to
their
broad
public
emissions
exposure,
motor
vehicle
gasolines
and
diesel
fuels,
and
their
additives,
were
designated.

The
regulations
at
40
CFR
79,
Subpart
F,
promulgated
on
May
27,
1994,
require
research
for
each
of
the
following
fuel/
additive
groups
whose
components
are
derived
from
conventional
petroleum,
heavy
oil
deposits,
coal,
tar
sands
and/
or
oil
sands:

(
1)
Gasoline
Baseline
Group
­
gasoline/
additive
elements
are
limited
to
carbon,
hydrogen,
oxygen,
nitrogen
and
sulphur
(
for
convenience,
hereby
referred
to
as
CHONS),
gasoline
oxygen
content
is
less
than
1.5
weight
percent,
and
the
gasoline
meets
the
American
Society
for
Testing
and
Materials
(
ASTM)
specifications.
3
Nonbaseline
Group
­
gasoline/
additive
elements
are
limited
to
CHONS,
gasoline
oxygen
content
is
1.5
weight
percent
or
greater,
and
the
gasoline
meets
ASTM
specifications.
A
group
is
established
for
each
oxygenate
(
e.
g.,
ethanol).

Atypical
Group
­
a
group
is
established
for
each
non­
CHONS
element
(
e.
g.,
manganese),
combination
of
non­
CHONS
elements,
property
that
does
not
meet
ASTM
specification,
or
combination
of
properties
that
do
not
meet
ASTM
specifications.

(
2)
Diesel
Baseline
Group
­
diesel/
additive
elements
are
limited
to
CHONS,
the
fuel
oxygen
content
is
less
than
1.0
weight
percent,
and
the
fuel
meets
ASTM
specifications.

Nonbaseline
Group
­
diesel/
additive
elements
are
limited
to
CHONS,
the
fuel
oxygen
content
is
1.0
weight
percent
or
greater,
and
the
fuel
meets
ASTM
specifications.
A
group
is
established
for
each
oxygenate.
An
exception
is
biodiesel,
which
is
one
group,
even
though
it
consists
of
mixed
alkyl
esters
of
plant
and/
or
animal
origin.

Atypical
Group
­
a
group
is
established
for
each
non­
CHONS
element
(
e.
g.,
iron),
combination
of
non­
CHONS
elements,
property
that
does
not
meet
ASTM
specification,
or
combination
of
properties
that
do
not
meet
ASTM
specifications.

The
regulations
also
require
research
for
each
gasoline,
diesel
fuel,
and
additive
group
that
is
derived
in
whole
or
in
part
from
sources
other
than
those
mentioned
above,
such
as
shale,
used
oil,
and
waste
plastics.
The
fuel/
additive
group
is
defined
by
the
source.
Research
is
also
required
for
fuels
that
do
not
meet
ASTM
specifications.

The
research
is
structured
into
three
tiers
of
requirements
for
each
group.
Tier
1
requires
an
emissions
characterization
and
a
literature
search
for
the
health
effects
of
those
emissions.
For
products
registered
as
of
May
27,
1994,
the
Tier
1
data
were
due
by
May
27,
1997.
For
products
currently
seeking
registration,
the
Tier
1
data
must
be
submitted
before
the
product
can
be
registered.
Tier
2
requires
short­
term
inhalation
exposures
of
laboratory
animals
to
emissions
to
screen
for
adverse
health
effects.
For
products
registered
as
of
May
27,
1994,
the
Tier
2
data
were
due
by
May
27,
1997,
or
evidence
of
a
contract
that
would
provide
the
Tier
2
data
by
May
27,
2000.
For
products
currently
seeking
registration,
the
Tier
2
data
are
due
before
registration
can
occur.
(
There
are
several
exceptions
to
the
above.
For
biodiesel
products,
the
Tier
1
deadline
was
March
17,
1998,
and
the
Tier
2
deadline
was
May
27,
2000.
For
atypical
products,
the
Tier
2
deadline
for
evidence
of
a
contract
was
November
27,
1998,
with
the
Tier
2
data
due
by
November
27,
2001.)
The
regulations
also
allow
EPA
to
establish
Alternative
Tier
2
requirements
in
lieu
of
standard
Tier
2,
if
warranted.
Follow­
up
studies,
if
required,
would
occur
under
Tier
3.

The
objective
of
the
program
is
to
determine
if
there
are
any
fuels
and/
or
additives
whose
evaporative
emissions
or
products
of
combustion
pose
a
particular
danger
to
public
health
or
4
welfare.
Section
211(
c)
of
the
Act
provides
EPA
with
the
authority
to
regulate
such
fuels
and
additives.
For
example,
the
use
of
lead
additives
in
gasoline,
gasoline
volatility,
and
the
sulphur
content
of
gasoline
and
diesel
fuel,
have
been
regulated
under
this
section.

There
are
several
exceptions
to
the
above,
in
order
to
lessen
the
burden
for
small
businesses.
Manufacturers
of
baseline
and/
or
nonbaseline
products,
who
have
an
annual
sales
revenue
of
less
than
$
50
million,
are
exempt
from
Tier
1
and
Tier
2.
Manufacturers
of
atypical
products,
who
have
an
annual
sales
revenue
of
less
than
$
10
million,
are
exempt
from
Tier
2.
There
are
less
burdensome
provisions
for
the
manufacturers
of
aerosol
additives.
Manufacturers
who
merely
relabel
a
registered
product
are
not
subject
to
Tier
1,
Tier
2
and
Tier
3.

In
1994
the
API
formed
a
consortium
of
the
major
fuel
and
additive
manufacturers.
In
1997
it
submitted
Tier
1
data
for
baseline
gasoline,
baseline
diesel,
and
six
nonbaseline
gasoline
groups
(
di­
isopropyl
ether
(
DIPE),
ethanol,
ethyl
tertiary
butyl
ether
(
ETBE),
methyl
tertiary
butyl
ether
(
MTBE),
tertiary
amyl
methyl
ether
(
TAME),
and
tertiary
butyl
alcohol
(
TBA)).
Tier
2
data
were
submitted
for
baseline
diesel.
In
1997
a
consortium
submitted
information
for
aerosol
additive
manufacturers.
In
1997
Tier
1
data
were
submitted
for
two
atypical
gasoline
groups
and
five
atypical
diesel
groups,
and
Tier
2
data
were
submitted
for
diesel.
In
1998
and
2000,
Tier
1
and
Tier
2
data
were
submitted
for
biodiesel,
respectively.
In
2000
and
2002,
Tier
1
and
Tier
2
data
were
submitted
for
summer
PuriNOx,
an
emulsion
of
water
and
diesel.
In
2003
Tier
1
data
were
submitted
for
Clean
Fuels
Technology
Emulsified
Diesel
Fuel.
In
2005
Tier
1
data
were
submitted
for
an
iron­
based
diesel
additive
known
as
CleanBoost.
In
2006
Tier
1
data
were
submitted
for
a
cerium
based
diesel
additive
known
as
Envirox.

On
August
20,
1997
the
API
was
informed
of
proposed
Alternative
Tier
2
requirements
for
baseline
gasoline
and
the
six
nonbaseline
gasoline
groups
for
which
Tier
1
data
were
submitted.
After
public
notice
and
comment,
and
discussions
with
API,
the
alternative
requirements
were
finalized,
and
API
was
notified
on
November
2,
1998.
Notice
was
published
in
the
Federal
Register.
The
research
is
in
progress.

In
1994
the
Ethyl
Corporation
(
Ethyl)
was
informed
that
Alternative
Tier
2
testing
would
be
required
for
its
manganese
additive
MMT
and
alternative
requirements
were
proposed
in
a
January
25,
1999
letter
to
Ethyl
and
announced
in
the
Federal
Register.
These
requirements
were
finalized
in
a
May
11,
2000
letter
to
Ethyl
and
announced
in
the
Federal
Register.
The
research
is
in
progress.

Alternative
Tier
2
requirements
were
also
established
for
winter
PuriNOx.
The
procedure
as
described
above
was
followed
and
the
data
were
submitted
in
2003..

2(
b)
Practical
Utility/
Users
of
the
Data
These
health­
effects
data
will
allow
decision
makers
to
assess
the
relative
risks
of
the
fuel/
additive
groups
described
above.
For
example,
some
individuals
appear
to
be
sensitive
to
the
emissions
from
gasoline/
oxygenate
blends,
citing
headaches
and
nausea.
Should
certain
formulations
show
unacceptable
levels
of
risk,
further
regulatory
action
could
be
taken.
5
The
data
may
also
be
used
by
non­
EPA
organizations,
such
as
fuel/
additive
producers
and
trade
organizations,
to
review
a
product's
potential
toxicity,
exposure,
or
registration
status,
to
determine
whether
the
submittal
of
further
information
would
be
duplicative,
or
to
contact
producers
to
use
the
registration
already
granted
and
share
in
the
cost
of
previous
compliance.
Public
interest
and
environmental
organizations
may
review
the
data
and
perform
their
own
evaluations.
Laboratories
may
review
the
test
reports
for
guidance
on
sound
laboratory
practices
and
data
generation.
Academic
and
medical
experts
may
use
the
information
in
research
or
to
compare
with
independent
findings.
State
and
local
agencies
responsible
for
protecting
the
public
health
will
be
very
interested
in
these
data
in
determining
which
fuel
formulations
present
the
least
public
health
risk.
The
California
Environmental
Protection
Agency
assessed
the
use
of
oxygenates
in
gasoline,
not
only
from
an
emissions
standpoint,
but
also
from
a
groundwater
contamination
standpoint,
due
to
leaking
storage
tanks.

3.
NONDUPLICATION,
CONSULTATIONS,
AND
OTHER
COLLECTION
CRITERIA
3(
a)
Nonduplication
To
our
knowledge,
this
is
the
only
program
which
requires
the
manufacturers
of
motor
vehicle
fuels
and
fuel
additives
to
develop
emissions
health­
effects
data.
The
regulations
allow
manufacturers
of
similar
products
to
group
and
test
one
representative
of
the
group,
thus
minimizing
duplicative
testing.

3(
b)
Public
Notice
A
Federal
Register
notice
requesting
public
comment
on
this
ICR
will
be
published.

3(
c)
Consultations
Burden
estimates
were
discussed
in
general
with
less
than
10
parties.

3(
d)
Effects
of
Less
Frequent
Collection
These
are
one­
time
requirements
for
each
product.

3(
e)
General
Guidelines
All
Office
of
Management
and
Budget
(
OMB)
guidelines
are
met.

3(
f)
Confidentiality
Section
211(
b)(
2)(
B)
of
the
Act
requires
that
the
results
of
the
Tier
2
health­
effects
testing
shall
not
be
considered
confidential.
Some
Tier
1
data,
particularly
those
related
to
6
composition,
could
be
claimed
as
confidential
and
would
be
subject
to
EPA's
freedom
of
information
provisions
at
40
CFR
2.

3(
g)
Sensitive
Questions
There
are
no
sensitive
questions.

4.
THE
RESPONDENTS
AND
THE
INFORMATION
COLLECTED
4(
a)
Respondents/
NAICS/
SIC
Codes
The
fuel
and
fuel
additive
manufacturers
are
related
to
the
following
major
group
North
American
Industry
Classification
System
(
NAICS)
six­
digit
codes
and
Standard
Industrialization
Classification
(
SIC)
four­
digit
codes:

324110
­
Petroleum
Refineries
2911
­
Diesel
Fuels
Manufacturing
2911
­
Gasoline
Made
in
Petroleum
Refineries
324119
­
All
Other
Petroleum
and
Coal
Products
Manufacturing
2999
­
Oil­
based
Additives
Made
From
Refined
Petroleum
325110
­
Petrochemical
Manufacturing
2865
­
Benzene,
Olefins,
Toluene,
and
Xylene
2869
­
Butane
325193
­
Ethyl
Alcohol
Manufacturing
2869
­
Ethanol
4(
b)
Information
Requested
(
i)
Data
Items
The
following
is
required
to
be
submitted
for
each
fuel
and
additive
subject
to
the
Tier
1
requirements
(
40
CFR
79.52):

1.
Name
of
the
manufacturer
and
name
of
the
fuel
or
additive;
2.
Group/
consortium
identification;
3.
Literature
search
over
the
past
30
years
for
existing
information
pertaining
to
health
effects,
environmental
effects,
and
emissions
of
the
fuel
or
additive;
includes
description
7
of
data
bases
searched,
search
period,
and
summary
of
relevant
information
found,
including
abstracts
and
references;
4.
Chemical
characterization
of
combustion
and
evaporative
emission
products;
report
on
emissions
generation
procedures,
analytic
methods,
and
results.
This
requirement
can
be
mitigated
by
adequate
existing
information
obtained
during
the
literature
search
in
item
3.
The
full
report(
s)
summarized
in
item
3
would
be
required.

The
following
is
required
to
be
submitted
for
each
fuel
and
additive
subject
to
the
Tier
2
or
Alternative
Tier
2
requirements
(
40
CFR
79.53):

1.
Name
of
the
manufacturer
and
name
of
the
fuel
or
additive;
2.
Group/
consortium
identification;
3.
Results
of
subchronic,
90­
day,
inhalation
exposure
of
lab
animals
to
combustion
emissions,
and
in
separate
testing,
if
applicable,
to
evaporative
emissions,
for
screening
of
general
toxicity,
carcinogenicity,
mutagenicity,
adult
reproduction/
teratogenicity,
pulmonary
toxicity,
and
neurotoxicity
for
Tier
2,
or
related
negotiated
testing
for
Alternative
Tier
2.
This
requirement
can
be
mitigated
by
adequate
existing
information
obtained
during
the
literature
search
of
Tier
1.
The
full
report(
s)
summarized
in
Tier
1
would
be
required.

The
following
is
required
to
be
submitted
for
each
fuel
and
additive
subject
to
the
Tier
3
requirements
(
40
CFR
79.54):

1.
Name
of
the
manufacturer
and
name
of
the
fuel
or
additive;
2.
Group/
consortium
identification;
3.
Results
of
follow­
up
testing
to
resolve
uncertainties
identified
upon
analysis
of
Tier
1
and/
or
Tier
2/
Alternative
Tier
2
data.
The
test
requirements
will
be
established
through
notice
and
comment
and
negotiation
with
the
manufacturer(
s).
The
burden
will
likely
be
comparable
to
that
for
Tier
2
testing.

See
40
CFR
79.59(
c)
for
the
detailed
documentation
requirements
of
the
Tier
1,
Tier
2,
and
Alternative
Tier
2
reports.
See
40
CFR
79.59(
d)
for
the
detailed
documentation
requirements
for
a
Tier
3
report.
There
are
no
recordkeeping
requirements.

(
ii)
Respondent
Activities
The
following
activities
are
required:

1.
Read
or
hear
the
regulations
at
40
CFR
79,
Subpart
F;
2.
Obtain
the
required
data;
3.
Review
the
data;
4.
Prepare
the
required
report(
s);
5.
Send
the
report(
s)
to
EPA.
8
5.
THE
INFORMATION
COLLECTED­­
AGENCY
ACTIVITIES,
COLLECTION
METHODOLOGY,
AND
INFORMATION
MANAGEMENT
5(
a)
Agency
Activities
The
following
activities
are
required:

1.
Respond
to
inquiries
on
the
Tier
1,
Tier
2,
Alternative
Tier
2,
and
Tier
3
requirements;
2.
Provide
copies
of
the
regulations;
3.
Review
the
Tier
1,
Tier
2,
Alternative
Tier
2,
and
Tier
3
reports;
4.
Upon
completion
of
a
review,
notify
the
submitter
that
the
report
is
adequate,
or,
if
it
is
inadequate,
notify
the
submitter
of
the
deficiencies;
5.
Establish
public
access
to
the
test
results,
as
required
by
the
Act,
while
maintaining
the
confidentiality
of
data
so
entitled;
6.
Store
the
reports.

5(
b)
Collection
Methodology
and
Management
The
reports
will
be
reviewed
by
the
Office
of
Transportation
and
Air
Quality
and
the
Office
of
Research
and
Development.
The
quality
of
the
data
will
be
determined
by
professionals
knowledgeable
with
emissions
and
health­
effects
testing.
The
review
will
be
manual.
The
nature
of
the
reports
makes
them
unsuitable
for
automatic
data
processing.
The
reports
will
be
available
to
the
public
in
hard
copy,
and,
if
so
submitted,
electronically.
They
will
be
stored
in
the
format
submitted.
5(
c)
Small
Entity
Flexibility
As
discussed
in
section
2(
a),
certain
small
businesses
are
exempt
from
some
or
all
of
these
requirements.

6.
ESTIMATING
THE
BURDEN
AND
THE
COST
OF
THE
COLLECTION
6(
a)
and
(
b)
Estimating
Respondent
Burden
and
Costs
Due
to
the
costs,
it
is
likely
that
only
limited
additional
Tier
1
research
will
be
done.
Future
fuels
and
additives
subject
to
Tier
1
will
almost
exclusively
be
those
that
can
group
with
existing
Tier
1
data,
and
likely
will
come
from
manufacturers
who
have
already
paid
for
the
Tier
1
data.
Thus,
it
is
estimated
that
there
will
only
be
one
Tier
1
submission
per
year
over
the
next
three
years.
However,
manufacturers
of
baseline
and
nonbaseline
products
with
less
than
$
50
million
in
annual
revenue
are
exempt
from
Tier
1,
so
there
will
be
continuing
registration
activity
in
that
area.

In
the
previous
ICR,
it
was
concluded
that
the
few
new
products
for
which
a
new
Tier
1
would
be
required
are
likely
to
be
in
the
atypical
or
nonbaseline
categories,
with
an
estimated
Tier
1
cost
of
about
$
350,000
per
product,
with
about
$
100,000
for
the
literature
search
and
9
about
$
250,000
for
the
emissions
characterization.
Two
recent
submitters
of
Tier
1
reports
said
that
their
costs
slightly
less.
Thus,
we
believe
that
the
$
350,000
estimate
is
still
appropriate.

The
$
350,000
estimate
was
determined
as
follows:

In
discussions
with
fewer
than
ten
fuel
and
fuel
additive
manufacturers,
four
labor
categories
were
identified
as
having
involvement:
managerial,
legal,
professional/
technical
(
prof/
tech),
and
clerical.
According
to
the
Bureau
of
Labor
Statistics,
Employer
Costs
for
Employee
Compensation
(
December
2005),
for
private
industry,
wages
and
benefits
were:

Managerial
$
43.48
per
hour
Prof/
Tech
$
43.48
per
hour
Clerical
$
19.61
per
hour
Assuming
the
managerial
and
legal
rates
are
comparable,
doubling
for
company
overhead
beyond
wages
and
benefits,
employing
a
2%
annual
inflation
factor
to
bring
the
rates
to
2006,
and,
for
convenience,
rounding
up
to
the
even
dollar,
gives
the
following
rates
that
will
be
used
in
this
ICR:

Total
Employer
Cost
Managerial
$
90
per
hour
Legal
$
90
per
hour
Prof/
Tech
$
90
per
hour
Clerical
$
40
per
hour
Worksheet
1:
Tier
1
Literature
Search
The
estimated
burden
hours
and
costs
are:

Activity
mgmt
legal
prof/
tech
clerical
read
regs
40/$
3600
40/$
3600
40/$
3600
40/$
1600
obtain
data
40/$
3600
40/$
3600
200/$
18,000
200/$
8000
review
data
40/$
3600
40/$
3600
200/$
18,000
200/$
8000
prepare
report
and
send
to
EPA
40/$
3600
40/$
3600
100/$
9000
100/$
4000
totals
160/$
14,400
160/$
14,400
540/$
48,600
540/$
21,600
1400/$
99,000
Capital/
start­
up
costs
for
the
literature
search
are
estimated
at
$
10,000
for
the
purchase
of
computer
hardware/
software
for
recording
the
search
and
the
purchase
of
filing
cabinets
for
10
storage.
Operating
and
maintenance
costs
are
estimated
at
$
2000
for
computer
maintenance,
document
storage,
and
shipping
of
the
report
and
documents
to
EPA.

Worksheet
2:
Tier
1
Emissions
Characterization
The
estimated
hours
and
costs
are:

Activity
mgmt
legal
prof/
tech
clerical
read
regs
40/$
3600
40/$
3600
40/$
3600
40/$
1600
obtain
data
40/$
3600
40/$
3600
500/$
45,000
500/$
20,000
review
data
40/$
3600
40/$
3600
100/$
9000
100/$
4000
prepare
report
and
send
to
EPA
40/$
3600
40/$
3600
100/$
9000
100/$
4000
totals
160/$
14,400
160/$
14,400
740/$
66,600
740/$
29,600
1800/$
125000
Capital/
start­
up
costs
are
estimated
at
$
25,000
for
the
purchase
of
test
engines
and
computer
hardware/
software.
Operating
and
maintenance
costs
are
estimated
at
$
90,000
for
lease
of
laboratory
space
and
test
equipment.
Thus,
the
total
estimated
cost
for
a
Tier
1
submission
is
$
99,000
+
$
10,000
+
$
2,000
+
$
125,000
+
$
25,000
+
$
90,000
=
$
351,000.

Standard
Tier
2/
Alternative
Tier
2/
Tier
3
activity
also
will
be
very
limited.
The
EPA
has
concluded
that
existing
data
cover
Tier
2
for
baseline
diesel.
Alternative
Tier
2
covers
baseline
gasoline,
the
six
major
nonbaseline
gasoline
oxygenates,
and
the
atypical
gasoline
additive
MMT.
Thus,
only
atypical
products
for
manufacturers
with
$
10
million
or
greater
in
annual
revenue,
and
new
gasoline
oxygenates
for
manufacturers
with
$
50
million
or
greater
in
annual
revenue,
remain
that
are
subject
to
the
standard
Tier
2or
Alternative
Tier
2
requirements.
While
EPA
has
yet
to
require
a
Tier
3,
it
is
likey
to
have
a
burden
similar
to
that
for
Tier
2/
Alternative
Tier
2.
EPA
estimates
that
there
will
be
three
standard
Tier
2/
Alternative
Tier
2/
Tier
3
submittals
over
the
next
three
years,
at
an
estimated
cost
of
about
$
1.6
million
each.
(
The
manufacturer
of
a
diesel
emulsion
estimated
its
Tier
2
cost
at
$
1.6
million.)

Worksheet
3:
Tier
2/
alternative
Tier
2/
Tier
3
Inhalation
Research
The
estimated
hours
and
costs
are:

Activity
mgmt
legal
prof/
tech
clerical
read
regs
160/$
14400
160/$
14400
160/$
14400
160/$
6400
obtain
data
160/$
14400
160/$
14400
8000/$
720000
4000/$
160000
11
review
data
160/$
14400
160/$
14400
800/$
72000
800/$
32000
prepare
report
and
send
to
EPA
160/$
14400
160/$
14400
400/$
36000
400/$
16000
totals
640/$
57600
640/$
57600
9360/$
842400
5360/$
214400
grand
total
16000/$
1,172,000
Capital/
start­
up
costs
are
estimated
at
$
150,000
for
the
purchase
of
animals,
cages/
related
equipment,
and
computer
hardware/
software.
Operating
and
maintenance
costs
are
estimated
at
$
250,000
for
the
lease
of
laboratory
space
and
test
equipment,
and
animal
supplies.
Thus,
the
total
estimated
cost
for
a
Tier
2
submission
is
$
1,172,000
+
$
150,000
+
$
250,000
=
$
1,572,000
It
is
estimated
that
API
will
spend
$
1.1
million
per
year,
including
$
20,000
per
year
in
capital/
start­
up
(
C/
S)
costs
and
$
180,000
per
year
in
operating
and
maintenance
(
O&
M)
costs,
over
the
next
three
years
in
conducting
its
Alternative
Tier
2
animal
testing.
Subtracting
C/
S
and
O&
M
costs
from
the
$
1.1
million
leaves
$
0.9
million,
and
assuming
(
as
in
the
previous
ICR)
an
average
of
$
100
per
hour
for
labor
and
benefits
for
this
specialized
Alternative
Tier
2
animal
research
,
results
in
an
annual
burden
of
9,000
hours.
It
is
assumed
that
API
will
submit
one
report
per
year.
The
reasons
for
the
C/
S
and
O&
M
costs
are
the
same
as
in
the
previous
paragraph
for
Tier
2
inhalation
research.

It
is
estimated
that
Afton
Chemical
Corporation
(
Afton)
will
spend
$
225,000
per
year,
including
$
5,000
per
year
in
C/
S
costs
and
$
25,000
per
year
in
O&
M
costs,
over
the
next
three
years
in
conducting
its
Alternative
Tier
2
animal
testing.
Subtracting
C/
S
and
O&
M
costs
from
the
$
225,000
leaves
$
195,000,
and
assuming
(
as
in
the
previous
ICR)
an
average
of
$
100
per
hour
for
labor
and
benefits
for
this
specialized
Alternative
Tier
2
animal
research,
results
in
an
annual
burden
of
1,950
hours.
It
is
assumed
that
Afton
will
submit
one
report
per
year.
The
reasons
for
the
costs
are
as
above.

6(
c)
Estimating
Agency
Burden
and
Cost
It
is
estimated
that
the
EPA
will
expend
about
one­
half
of
a
Full
Time
Equivalent
(
FTE)
annually,
allocated
among
several
professionals,
for
the
activities
listed
in
section
5(
a).
Assuming
$
75
per
hour,
for
government
salary
and
overhead
at
the
professional
level,
gives
an
annual
cost
of
$
78,000
to
the
EPA.
Costs
for
storage
and
public
availability
will
be
nominal.

6(
d)
Estimating
the
Respondent
Universe
and
Total
Burden
and
Costs
As
discussed,
it
is
anticipated
that
Tier
1
and
standard
Tier
2/
Alternative
Tier
2/
Tier
3
activities
will
be
very
limited,
with
three
Tier
1
submissions
and
three
Tier
2/
Alternative
Tier
2/
Tier
3
submissions
over
the
next
three
years,
at
an
estimated
cost
of
$
0.35
million
for
each
Tier
1
and
$
1.6
million
for
each
Tier
2/
Alternative
Tier
2/
Tier
3,
for
an
annual
burden
of
about
$
1.95
12
million.
Adding
$
1.1
million
per
year
for
API
and
$
0.225
million
per
year
for
Ethyl
gives
an
annual
industry
burden
estimate
of
$
3.3
million.
The
estimated
annual
EPA
burden
is
$
78,000.

6(
e)
Bottom
Line
Burden
Hours
and
Cost
Table
Worksheet
4:
Annual
Industry
Burden
Activity
Number
Capital/
Start­
up
O&
M
costs
Total
Hours
Total
Cost
Tier
1
1
$
35,000
$
92,000
3,200
$
351,000
Tier
2/
1
$
150,000
$
250,000
16,000
$
1,572,000
Alt.
2/
T3
API
1
$
20,000
$
180,000
9,000
$
1,100,000
Afton
1
$
5,000
$
2,500
1,950
$
225,000
Totals
4
$
210,000
$
524,5000
30,150
$
3,248,000
6(
f)
Reasons
for
Change
in
Burden
The
API
and
Afton
testing
programs
are
winding
down
as
they
near
completion.
Other
activities
are
estimated
to
be
at
about
the
same
level.

Worksheet
5:
Change
in
Burden
­
Annual
Responses/
Annual
Hours
Previous
Requested
Change
Reason
4/
60,700
4/
30,150
0/
30,550
Adjustment
(
see
paragraph
6(
f))

6(
g)
Burden
Statements
Burden
Statement:
The
annual
public
reporting
and
recordkeeping
burden
for
this
collection
of
information
is
estimated
to
average
7,538
hours
per
response.
Burden
means
the
total
time,
effort,
or
financial
resources
expended
by
persons
to
generate,
maintain,
retain,
or
disclose
or
provide
information
to
or
for
a
Federal
agency.
This
includes
the
time
needed
to
review
instructions;
develop,
acquire,
install,
and
utilize
technology
and
systems
for
the
purposes
of
collecting,
validating,
and
verifying
information,
processing
and
maintaining
information,
and
disclosing
and
providing
information;
adjust
the
existing
ways
to
comply
with
any
previously
applicable
instructions
and
requirements;
train
personnel
to
be
able
to
respond
to
a
collection
of
information;
search
data
sources;
complete
and
review
the
collection
of
information;
and
transmit
or
otherwise
disclose
the
information.
To
comment
on
the
Agency's
need
for
this
information,
the
accuracy
of
the
provided
burden
estimates,
and
any
suggested
methods
for
minimizing
respondent
burden,
including
the
use
of
automated
collection
techniques,
EPA
has
established
a
public
docket
for
this
ICR
under
Docket
ID
No.
EPA­
HQ­
OAR­
2006­
0525,
which
is
available
for
public
viewing
at
the
Office
of
13
Air
and
Radiation
Docket
in
the
EPA
Docket
Center
(
EPA/
DC),
EPA
West,
Room
B102,
1301
Constitution
Ave.,
NW,
Washington,
DC.
The
EPA
Docket
Center
Public
Reading
Room
is
open
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Reading
Room
is
(
202)
566­
1744,
and
the
telephone
number
for
the
Office
of
Air
and
Radiation
Docket
is
(
202)
566­
1742).
An
electronic
version
of
the
public
docket
is
available
through
www.
regulations.
gov.
Use
this
site
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Once
in
the
system,
select
"
search,"
then
key
in
the
docket
ID
number
identified
above.
Also,
you
can
send
comments
to
the
Office
of
Information
and
Regulatory
Affairs,
Office
of
Management
and
Budget,
725
17th
Street,
NW,
Washington,
DC
20503,
Attention:
Desk
Office
for
EPA.
Please
include
the
EPA
Docket
ID
No.
(
OAR­
2002­
0015
)
and
OMB
control
number
(
2060­
0297)
in
any
correspondence.

Part
B
of
the
Supporting
Statement
­
Not
Applicable
to
this
ICR