Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Fuels and Fuel Additives: Health-
Effects Research Protocols (Renewal); EPA ICR No. 1696.05, OMB Control
No. 2060-0297
[Federal Register: November 6, 2006 (Volume 71, Number 214)]
[Notices]
[Page 64950-64951]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06no06-29]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OAR-2006-0525; FRL-8240-2]
Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Fuels and Fuel Additives: Health-
Effects Research Protocols (Renewal); EPA ICR No. 1696.05, OMB Control
No. 2060-0297
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: In compliance with the Paperwork Reduction Act (PRA)(44 U.S.C.
3501 et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR, which is abstracted below, describes the
nature of the information collection and its estimated burden and cost.
DATES: Additional comments may be submitted on or before December 6, 2006.
ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OAR-
2006-0525, to (1) EPA online using http://www.regulations.gov (our
preferred method), by e-mail to a-and-r-docket@epa.gov, or by mail to:
EPA Docket Center, Environmental Protection Agency, Air and Radiation
Docket, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and (2) OMB
by mail to: Office of Information and Regulatory Affairs, Office of
Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th
Street, NW., Washington, DC 20503.
Note: The EPA Docket Center suffered damage due to flooding
during the last week of June 2006. The Docket Center is continuing
to operate. However, during the cleanup, there will be temporary
changes to Docket Center telephone numbers, addresses, and hours of
operation for people who wish to visit the Public Reading Room to
view documents. Consult EPA's Federal Register notice at 71 FR 38147
(July 5, 2006) or the EPA Web site at http://www.epa.gov/epahome/
dockets.htm for current information on docket status, locations and
telephone numbers.
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: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On July 17, 2006 (71 FR 40513), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any
additional comments on this ICR should be submitted to EPA and OMB
within 30 days of this notice.
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
http://www.regulations.gov, or in person viewing at the Air and
Radiation Docket and Information Center in the EPA Docket Center (EPA/
DC), EPA West, Room B102, 1301 Constitution Ave., 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 and Information Center is 202-566-1742.
Use EPA's electronic docket and comment system at
http://www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov as EPA
receives them and without change, unless the comment contains
copyrighted material, CBI, or other information whose public disclosure
is restricted by statute. For further information about the electronic
docket, go to http://www.regulations.gov.
Title: Fuels and Fuel Additives: Health-Effects Research Protocols
(Renewal).
ICR Numbers: EPA ICR No. 1696.05, OMB Control No. 2060-0297.
ICR Status: This ICR is scheduled to expire on November 30, 2006.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
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 No. 0309.11, OMB Control No. 2060-
0150). 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, when used in
gasoline as 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/or
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,
[[Page 64951]]
baseline fuel additives, and the prominent nonbaseline oxygenated
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.
Respondents/Affected Entities: Manufacturers of Fuels and Fuel
Additives.
Estimated Number of Respondents: 4.
Frequency of Response: On Occasion.
Estimated Total Annual Hour Burden: 30,150.
Estimated Total Annual Cost: $3.2 million, includes $757,000
annualized capital and O&M costs.
Changes in the Estimates: There is a decrease of 30,550 hours in
the total estimated burden currently identified in the OMB Inventory of
Approved ICR Burdens. This decrease is the result of reduced activity
as the two alternative Tier 2 testing programs near completion.
Dated: October 30, 2006.
Oscar Morales,
Director, Collection Strategies Division.
[FR Doc. E6-18658 Filed 11-3-06; 8:45 am]
BILLING CODE 6560-50-P