Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Fuels and Fuel Additives-Health-Effects Research Requirements for Manufacturers; EPA ICR No. 1696.05, OMB Control No. 2060-0297, 40513-40515 [E6-11257]
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Federal Register / Vol. 71, No. 136 / Monday, July 17, 2006 / Notices
EPA ICR Number: 1053.08; OMB
Control Number 2060–0023.
This is a request to renew an existing
approved collection that is scheduled to
expire on July 31, 2006. Under the OMB
regulations, the Agency may continue to
conduct or sponsor the collection of
information while this submission is
pending at OMB.
Abstract: Owners or operators of
electric utility steam generating units
subject to the New Source Performance
Standards (NSPS) subpart Da must make
one-time notification of construction/
reconstruction, anticipated and actual
startup, initial performance test,
physical or operational changes, and
demonstration of a continuous
monitoring system. They also must
submit a report on initial performance
test results, monitoring results, and
excess emissions. Records must be
maintained of startups, shutdowns,
malfunctions, periods when the
continuous monitoring system is
inoperative, and of various fuel
combustion and pollutant emission
parameters.
The required notifications are used to
inform the Agency or delegated
authority when a source becomes
subject to the standard. Performance test
reports are needed, as these are the
Agency’s records of a source’s initial
capability to comply with the emission
standard, and serve as a record of the
operating conditions under which
compliance was achieved. The
monitoring and excess emissions reports
are used for problem identification, as a
check on source operation and
maintenance, and for compliance
determination. The information
collected from recordkeeping and
reporting requirements are used for
targeting inspections and for other uses
in compliance and enforcement
programs.
Responses to these information
collections are deemed mandatory by
section 114(a) of the Clean Air Act. The
required information consists of
emissions data and other information
that have been determined not to be
private. However, any information
submitted to the Agency for which a
claim of confidentiality is made will be
safeguarded according to the Agency
policies set forth in Title 40, Chapter 1,
Part 2, Subpart B—Confidentiality of
Business Information (see 40 CFR 2; 41
FR 36902, September 1, 1976; amended
by 43 FR 4000, September 8, 1978; 43
FR 42251, September 20, 1978; 44 FR
17674, March 23, 1979).
An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a currently valid OMB
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control number. The OMB control
numbers for EPA’s regulations are listed
in 40 CFR part 9 and 48 CFR chapter 15,
and are identified on the form and/or
instrument, if applicable.
Burden Statement: The annual public
reporting and recordkeeping burden for
this collection of information is
estimated to average 85 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
respond to a collection of information;
search data sources; complete and
review the collection of information;
and transmit, or otherwise disclose the
information.
Respondents/Affected Entities:
Owners or operators of electric utility
steam generating units subject to
subpart Da.
Estimated Number of Respondents:
655.
Frequency of Response:
Semiannually, quarterly.
Estimated Total Annual Hour Burden:
133,553.
Estimated Total Annual Cost:
$19,490,000, includes $2,200,000
annualized capital and $9,660,000 O&M
costs.
Dated: July 8, 2006.
Oscar Morales,
Director, Collection Strategies Division.
[FR Doc. E6–11256 Filed 7–14–06; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OAR–2006–0525; FRL–8198–4]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Registration of
Fuels and Fuel Additives—HealthEffects Research Requirements for
Manufacturers; EPA ICR No. 1696.05,
OMB Control No. 2060–0297
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: In compliance with the
Paperwork Reduction Act (PRA) (44
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40513
U.S.C. 3501 et seq., this document
announces that EPA is planning to
submit a request to renew an existing
approved Information Collection
Request (ICR) to the Office of
Management and Budget (OMB). This
ICR is scheduled to expire on November
30, 2006. Before submitting the ICR to
OMB for review and approval, EPA is
soliciting comments on specific aspects
of the proposed information collection
as described below.
DATES: Comments must be submitted on
or before September 15, 2006.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–HQ–
OAR–2006–0525, by one of the
following methods:
• www.regulations.gov: Follow the
on-line instructions for submitting
comments.
• E-mail: a-and-r-docket@epa.gov.
• Fax: (202) 566–1741.
• Mail: Air and Radiation Docket,
Docket ID No. EPA–HQ–OAR–2006–
0525, Environmental Protection Agency,
Mailcode: 6102T, 1200 Pennsylvania
Avenue, NW., Washington, DC 20460.
• Hand Delivery: EPA Docket Center,
Room B102, EPA West Building, 1301
Constitution Avenue, NW., Washington,
DC 20460. Such deliveries are only
accepted during the Docket’s normal
hours of operation, and special
arrangements should be made for
deliveries of boxed information.
Instructions: Direct your comments to
Docket ID No. EPA–HQ–OAR–2006–
0525. EPA’s policy is that all comments
received will be included in the public
docket without change and may be
made available online at
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through www.regulations.gov
or e-mail. The www.regulations.gov Web
site is an ‘‘anonymous access’’ system,
which means EPA will not know your
identity or contact information unless
you provide it in the body of your
comment. If you send an e-mail
comment directly to EPA without going
through www.regulations.gov your
e-mail address will be automatically
captured and included as part of the
comment that is placed in the public
docket and made available on the
Internet. If you submit an electronic
comment, EPA recommends that you
include your name and other contact
information in the body of your
comment and with any disk or CD–ROM
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Federal Register / Vol. 71, No. 136 / Monday, July 17, 2006 / Notices
you submit. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
EPA may not be able to consider your
comment. Electronic files should avoid
the use of special characters, any form
of encryption, and be free of any defects
or viruses. For additional information
about EPA’s public docket visit the EPA
Docket Center homepage at https://
www.epa.gov/epahome/dockets.htm.
FOR FURTHER INFORMATION CONTACT:
James W. Caldwell, Office of
Transportation and Air Quality,
Mailcode: 6406J, Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460;
telephone number: (202) 343–9303; fax
number: (202) 343–2802; e-mail address:
caldwell.jim@epa.gov.
SUPPLEMENTARY INFORMATION:
How Can I Access the Docket and/or
Submit Comments?
EPA has established a public docket
for this ICR under Docket ID No. EPA–
HQ–OAR–2006–0525, which is
available for online viewing at
www.regulations.gov, or in person
viewing at the Air and Radiation Docket
in the EPA Docket Center (EPA/DC),
EPA West, Room B102, 1301
Constitution Avenue, NW., Washington,
DC. The EPA/DC Public Reading Room
is open from 8 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 Air and
Radiation Docket is 202–566–1742.
Use www.regulations.gov to obtain a
copy of the draft collection of
information, submit or view public
comments, access the index listing of
the contents of the 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 in this
document.
rwilkins on PROD1PC63 with NOTICES
What Information Is EPA Particularly
Interested in?
Pursuant to section 3506(c)(2)(A) of
the PRA, EPA specifically solicits
comments and information to enable it
to:
(i) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the Agency, including
whether the information will have
practical utility;
(ii) Evaluate the accuracy of the
Agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
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(iii) Enhance the quality, utility, and
clarity of the information to be
collected; and
(iv) Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated electronic,
mechanical, or other technological
collection techniques or other forms of
information technology, e.g., permitting
electronic submission of responses. In
particular, EPA is requesting comments
from very small businesses (those that
employ less than 25) on examples of
specific additional efforts that EPA
could make to reduce the paperwork
burden for very small businesses
affected by this collection.
What Should I Consider When I
Prepare My Comments for EPA?
You may find the following
suggestions helpful for preparing your
comments:
1. Explain your views as clearly as
possible and provide specific examples.
2. Describe any assumptions that you
used.
3. Provide copies of any technical
information and/or data you used that
support your views.
4. If you estimate potential burden or
costs, explain how you arrived at the
estimate that you provide.
5. Offer alternative ways to improve
the collection activity.
6. Make sure to submit your
comments by the deadline identified
under DATES.
7. To ensure proper receipt by EPA,
be sure to identify the docket ID number
assigned to this action in the subject
line on the first page of your response.
You may also provide the name, date,
and Federal Register citation.
What Information Collection Activity or
ICR Does This Apply to?
Affected entities: Entities potentially
affected by this action are the
manufacturers of motor-vehicle
gasoline, motor-vehicle diesel fuel, and
additives for those fuels.
Title: Registration of Fuels and Fuel
Additives—Health-Effects Research
Requirements for Manufacturers.
ICR numbers: EPA ICR No. 1696.05,
OMB Control No. 2060–0297.
ICR status: This ICR is currently
scheduled to expire on November 30,
2006. An Agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information,
unless it displays a currently valid OMB
control number. The OMB control
numbers for EPA’s regulations in title 40
of the CFR, after appearing in the
Federal Register when approved, are
listed in 40 CFR part 9, are displayed
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either by publication in the Federal
Register or by other appropriate means,
such as on the related collection
instrument or form, if applicable. The
display of OMB control numbers in
certain EPA regulations is consolidated
in 40 CFR part 9.
Abstract: In accordance with the
regulations at 40 CFR part 79, Subparts
A, B, C, and D, Registration of Fuels and
Fuel Additives, manufacturers
(including importers) of motor-vehicle
gasoline, motor-vehicle diesel fuel, and
additives for those fuels, are required to
have these products registered by the
EPA prior to their introduction into
commerce. Registration involves
providing a chemical description of the
fuel or additive, and certain technical,
marketing, and health-effects
information. The development of
health-effects data, as required by 40
CFR part 79, subpart F, is the subject of
this ICR. The information collection
requirements for Subparts A through D,
and the supplemental notification
requirements of subpart F (indicating
how the manufacturer will satisfy the
health-effects data requirements) are
covered by a separate ICR (EPA ICR
Number 309.11, OMB Control Number
2060–1050). The health-effects data will
be used to determine if there are any
products which have evaporative or
combustion emissions that may pose an
unreasonable risk to public health, thus
meriting further investigation and
potential regulation. This information is
required for specific groups of fuels and
additives as defined in the regulations.
For example, gasoline and gasoline
additives which consist of only carbon,
hydrogen, oxygen, nitrogen, and/or
sulfur, and which involve a gasoline
oxygen content of less than 1.5 weight
percent, fall into a ‘‘baseline’’ group.
Oxygenates, such as ethanol and ethyl
tertiary butyl ether, when used in
gasoline at an oxygen level of at least 1.5
weight percent, define separate
‘‘nonbaseline’’ groups for each
oxygenate. Additives which contain
elements other than carbon, hydrogen,
oxygen, nitrogen, and sulfur fall into
separate ‘‘atypical’’ groups. There are
similar grouping requirements for diesel
fuel and diesel fuel additives.
Manufacturers may perform the
research independently or may join
with other manufacturers to share in the
costs for each applicable group. Several
research consortiums (groups of
manufacturers) have been formed. The
largest consortium, organized by the
American Petroleum Institute (API),
represents most of the manufacturers of
baseline gasoline, baseline diesel fuel,
baseline fuel additives, and the
prominent nonbaseline oxygenated
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additives for gasoline. The research is
structured into three tiers of
requirements for each group. Tier 1
requires an emissions characterization
and a literature search for information
on the health effects of those emissions.
Voluminous Tier 1 data for gasoline and
diesel fuel were submitted by API and
others in 1997. Tier 1 data have been
submitted for biodiesel, water/diesel
emulsions, and several atypical
additives. Tier 2 requires short-term
inhalation exposures of laboratory
animals to emissions to screen for
adverse health effects. Tier 2 data have
been submitted for baseline diesel,
biodiesel, and water/diesel emulsions.
Alternative Tier 2 testing can be
required in lieu of standard Tier 2
testing if EPA concludes that such
testing would be more appropriate. The
EPA reached that conclusion with
respect to gasoline and gasolineoxygenate blends, and alternative
requirements were established for the
API consortium for baseline gasoline
and six gasoline-oxygenate blends.
Alternative Tier 2 requirements have
also been established for the manganese
additive MMT manufactured by the
Afton Chemical Corporation (formerly
the Ethyl Corporation). Tier 3 provides
for follow-up research, at EPA’s
discretion, when remaining
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
emissions from a fuel or additive. To
date, EPA has not imposed any Tier 3
requirements. Under Section 211 of the
Clean Air Act, (1) submission of the
health-effects information is necessary
for a manufacturer to obtain registration
of a motor-vehicle gasoline, diesel fuel,
or fuel additive, and thus be allowed to
introduce that product into commerce,
and (2) the information shall not be
considered confidential.
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
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previously applicable instructions and
requirements which have subsequently
changed; 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.
The ICR provides a detailed
explanation of the Agency’s estimate,
which is only briefly summarized here:
Estimated total number of potential
respondents: 4.
Frequency of response: On occasion.
Estimated total average number of
responses for each respondent: 1.
Estimated total annual burden hours:
30,150.
Estimated total annual costs: $3.2
million. This includes an estimated
burden cost of $2.5 million and an
estimated cost of $0.7 million for capital
investment or maintenance and
operational costs.
Are There Changes in the Estimates
From the Last Approval?
There is a decrease of 30,550 hours in
the total estimated annual respondent
burden compared with that identified in
the ICR currently approved by OMB.
This decrease reflects EPA’s updating of
burden estimates. The two Alternative
Tier 2 testing programs noted above,
and covered in the previous ICR, have
completed most of the testing
requirements. They will have
significantly reduced activity as the
programs near completion over the next
three years. Although there will likely
be new fuels and additives for which
testing will be required, such testing is
not expected to be as extensive as the
two programs noted above.
What Is the Next Step in the Process for
This ICR?
EPA will consider the comments
received and amend the ICR as
appropriate. The final ICR package will
then be submitted to OMB for review
and approval pursuant to 5 CFR
1320.12. At that time, EPA will issue
another Federal Register notice
pursuant to 5 CFR 1320.5(a)(1)(iv) to
announce the submission of the ICR to
OMB and the opportunity to submit
additional comments to OMB. If you
have any questions about this ICR or the
approval process, please contact the
technical person listed under FOR
FURTHER INFORMATION CONTACT.
Dated: July 11, 2006.
Margo Tsirigotis Oge,
Director, Office of Transportation and Air
Quality.
[FR Doc. E6–11257 Filed 7–14–06; 8:45 am]
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ENVIRONMENTAL PROTECTION
AGENCY
[FRL–8198–3]
Science Advisory Board (SAB) Staff
Office; Notification of an Upcoming
Teleconference of the Air Quality
Modeling Subcommittee of the EPA’s
Advisory Council on Clean Air
Compliance Analysis
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: The EPA Science Advisory
Board (SAB) Staff Office announces a
public teleconference of the Air Quality
Modeling Subcommittee (AQMS), a
subcommittee of the EPA’s Advisory
Council on Clean Air Compliance
Analysis (Council).
DATES: The public teleconference will
be held on August 7, 2006, from 1 p.m.
to 3 p.m. (eastern daylight time).
FOR FURTHER INFORMATION CONTACT:
Members of the public who wish to
obtain the call-in number and access
code for the teleconference may contact
Dr. Holly Stallworth, Designated Federal
Officer (DFO), by mail at EPA SAB Staff
Office (1400F), U.S. EPA, 1200
Pennsylvania Avenue, NW.,
Washington, DC 20460; by telephone at
(202) 343–9867; or by e-mail at
stallworth.holly@epa.gov. General
information about the SAB may be
found on the SAB Web site at https://
www.epa.gov/sab.
SUPPLEMENTARY INFORMATION:
Background: The Advisory Council
on Clean Air Compliance Analysis is a
statutorily-mandated peer review group
charged with providing advice,
information and recommendations to
the Agency on technical and economic
aspects of studies prepared by EPA
relating to the benefits and costs of the
CAA and its Amendments. The Council
is a Federal advisory committee
chartered under the Federal Advisory
Committee Act (FACA), as amended, 5
U.S.C., App. Pursuant to a requirement
under section 812 of the 1990 Clean Air
Act Amendments, EPA conducts
periodic studies to assess the benefits
and the costs of the Clean Air Act. The
Council has been the chief reviewing
body for these studies and has issued
advice on a retrospective study issued
in 1997, a prospective study issued in
1999, and, since 2003, analytic
blueprints for a second prospective
study on the costs and benefits of clean
air programs covering the years 1990–
2020. OAR’s Web site on these section
812 studies may be found at: https://
www.epa.gov/oar/sect812/.
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]]>Agencies
[Federal Register Volume 71, Number 136 (Monday, July 17, 2006)]
[Notices]
[Pages 40513-40515]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-11257]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OAR-2006-0525; FRL-8198-4]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Registration of Fuels and Fuel Additives--Health-
Effects Research Requirements for Manufacturers; EPA ICR No. 1696.05,
OMB Control No. 2060-0297
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq., this document announces that EPA is planning to
submit a request to renew an existing approved Information Collection
Request (ICR) to the Office of Management and Budget (OMB). This ICR is
scheduled to expire on November 30, 2006. Before submitting the ICR to
OMB for review and approval, EPA is soliciting comments on specific
aspects of the proposed information collection as described below.
DATES: Comments must be submitted on or before September 15, 2006.
ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2006-0525, by one of the following methods:
www.regulations.gov: Follow the on-line instructions for
submitting comments.
E-mail: a-and-r-docket@epa.gov.
Fax: (202) 566-1741.
Mail: Air and Radiation Docket, Docket ID No. EPA-HQ-OAR-
2006-0525, Environmental Protection Agency, Mailcode: 6102T, 1200
Pennsylvania Avenue, NW., Washington, DC 20460.
Hand Delivery: EPA Docket Center, Room B102, EPA West
Building, 1301 Constitution Avenue, NW., Washington, DC 20460. Such
deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2006-0525. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or e-mail.
The www.regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through www.regulations.gov
your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD-ROM
[[Page 40514]]
you submit. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses. For additional information about EPA's public docket visit
the EPA Docket Center homepage at https://www.epa.gov/epahome/
dockets.htm.
FOR FURTHER INFORMATION CONTACT: James W. Caldwell, Office of
Transportation and Air Quality, Mailcode: 6406J, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (202) 343-9303; fax number: (202) 343-2802; e-mail
address: caldwell.jim@epa.gov.
SUPPLEMENTARY INFORMATION:
How Can I Access the Docket and/or Submit Comments?
EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OAR-2006-0525, which is available for online viewing at
www.regulations.gov, or in person viewing at the Air and Radiation
Docket in the EPA Docket Center (EPA/DC), EPA West, Room B102, 1301
Constitution Avenue, NW., Washington, DC. The EPA/DC Public Reading
Room is open from 8 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 Air and Radiation Docket is 202-
566-1742.
Use www.regulations.gov to obtain a copy of the draft collection of
information, submit or view public comments, access the index listing
of the contents of the 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 in this
document.
What Information Is EPA Particularly Interested in?
Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically
solicits comments and information to enable it to:
(i) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility;
(ii) Evaluate the accuracy of the Agency's estimate of the burden
of the proposed collection of information, including the validity of
the methodology and assumptions used;
(iii) Enhance the quality, utility, and clarity of the information
to be collected; and
(iv) Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.
What Should I Consider When I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible and provide specific
examples.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used
that support your views.
4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
5. Offer alternative ways to improve the collection activity.
6. Make sure to submit your comments by the deadline identified
under DATES.
7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.
What Information Collection Activity or ICR Does This Apply to?
Affected entities: Entities potentially affected by this action are
the manufacturers of motor-vehicle gasoline, motor-vehicle diesel fuel,
and additives for those fuels.
Title: Registration of Fuels and Fuel Additives--Health-Effects
Research Requirements for Manufacturers.
ICR numbers: EPA ICR No. 1696.05, OMB Control No. 2060-0297.
ICR status: This ICR is currently scheduled to expire on November
30, 2006. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information, unless it displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register when approved, are listed in 40 CFR part 9, are displayed
either by publication in the Federal Register or by other appropriate
means, such as on the related collection instrument or form, if
applicable. The display of OMB control numbers in certain EPA
regulations is consolidated in 40 CFR part 9.
Abstract: In accordance with the regulations at 40 CFR part 79,
Subparts A, B, C, and D, Registration of Fuels and Fuel Additives,
manufacturers (including importers) of motor-vehicle gasoline, motor-
vehicle diesel fuel, and additives for those fuels, are required to
have these products registered by the EPA prior to their introduction
into commerce. Registration involves providing a chemical description
of the fuel or additive, and certain technical, marketing, and health-
effects information. The development of health-effects data, as
required by 40 CFR part 79, subpart F, is the subject of this ICR. The
information collection requirements for Subparts A through D, and the
supplemental notification requirements of subpart F (indicating how the
manufacturer will satisfy the health-effects data requirements) are
covered by a separate ICR (EPA ICR Number 309.11, OMB Control Number
2060-1050). The health-effects data will be used to determine if there
are any products which have evaporative or combustion emissions that
may pose an unreasonable risk to public health, thus meriting further
investigation and potential regulation. This information is required
for specific groups of fuels and additives as defined in the
regulations. For example, gasoline and gasoline additives which consist
of only carbon, hydrogen, oxygen, nitrogen, and/or sulfur, and which
involve a gasoline oxygen content of less than 1.5 weight percent, fall
into a ``baseline'' group. Oxygenates, such as ethanol and ethyl
tertiary butyl ether, when used in gasoline at an oxygen level of at
least 1.5 weight percent, define separate ``nonbaseline'' groups for
each oxygenate. Additives which contain elements other than carbon,
hydrogen, oxygen, nitrogen, and sulfur fall into separate ``atypical''
groups. There are similar grouping requirements for diesel fuel and
diesel fuel additives.
Manufacturers may perform the research independently or may join
with other manufacturers to share in the costs for each applicable
group. Several research consortiums (groups of manufacturers) have been
formed. The largest consortium, organized by the American Petroleum
Institute (API), represents most of the manufacturers of baseline
gasoline, baseline diesel fuel, baseline fuel additives, and the
prominent nonbaseline oxygenated
[[Page 40515]]
additives for gasoline. The research is structured into three tiers of
requirements for each group. Tier 1 requires an emissions
characterization and a literature search for information on the health
effects of those emissions. Voluminous Tier 1 data for gasoline and
diesel fuel were submitted by API and others in 1997. Tier 1 data have
been submitted for biodiesel, water/diesel emulsions, and several
atypical additives. Tier 2 requires short-term inhalation exposures of
laboratory animals to emissions to screen for adverse health effects.
Tier 2 data have been submitted for baseline diesel, biodiesel, and
water/diesel emulsions. Alternative Tier 2 testing can be required in
lieu of standard Tier 2 testing if EPA concludes that such testing
would be more appropriate. The EPA reached that conclusion with respect
to gasoline and gasoline-oxygenate blends, and alternative requirements
were established for the API consortium for baseline gasoline and six
gasoline-oxygenate blends. Alternative Tier 2 requirements have also
been established for the manganese additive MMT manufactured by the
Afton Chemical Corporation (formerly the Ethyl Corporation). Tier 3
provides for follow-up research, at EPA's discretion, when remaining
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 emissions from a fuel or
additive. To date, EPA has not imposed any Tier 3 requirements. Under
Section 211 of the Clean Air Act, (1) submission of the health-effects
information is necessary for a manufacturer to obtain registration of a
motor-vehicle gasoline, diesel fuel, or fuel additive, and thus be
allowed to introduce that product into commerce, and (2) the
information shall not be considered confidential.
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 which have subsequently changed; 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.
The ICR provides a detailed explanation of the Agency's estimate,
which is only briefly summarized here:
Estimated total number of potential respondents: 4.
Frequency of response: On occasion.
Estimated total average number of responses for each respondent: 1.
Estimated total annual burden hours: 30,150.
Estimated total annual costs: $3.2 million. This includes an
estimated burden cost of $2.5 million and an estimated cost of $0.7
million for capital investment or maintenance and operational costs.
Are There Changes in the Estimates From the Last Approval?
There is a decrease of 30,550 hours in the total estimated annual
respondent burden compared with that identified in the ICR currently
approved by OMB. This decrease reflects EPA's updating of burden
estimates. The two Alternative Tier 2 testing programs noted above, and
covered in the previous ICR, have completed most of the testing
requirements. They will have significantly reduced activity as the
programs near completion over the next three years. Although there will
likely be new fuels and additives for which testing will be required,
such testing is not expected to be as extensive as the two programs
noted above.
What Is the Next Step in the Process for This ICR?
EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. At that time, EPA will
issue another Federal Register notice pursuant to 5 CFR
1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the
opportunity to submit additional comments to OMB. If you have any
questions about this ICR or the approval process, please contact the
technical person listed under FOR FURTHER INFORMATION CONTACT.
Dated: July 11, 2006.
Margo Tsirigotis Oge,
Director, Office of Transportation and Air Quality.
[FR Doc. E6-11257 Filed 7-14-06; 8:45 am]
BILLING CODE 6560-50-P
