[Federal Register Volume 68, Number 63 (Wednesday, April 2, 2003)]
[Notices]
[Pages 16020-16021]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-7971]


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ENVIRONMENTAL PROTECTION AGENCY

[OAR-2003-0015; FRL-7475-7]


Agency Information Collection Activities; Submission of EPA ICR 
No. 1696.04 (OMB No. 2060-0297) to OMB for Review and Approval; Comment 
Request

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 
et seq.), this document announces that the following Information 
Collection Request (ICR) has been forwarded to the Office of Management 
and Budget (OMB) for review and approval: Fuels and Fuel Additives--
Health-Effects Research Protocols--40 CFR part 79, subpart F. This ICR 
describes the nature of the information collection and its estimated 
burden and cost.

DATES: Additional comments may be submitted on or before May 2, 2003.

ADDRESSES: Follow the detailed instructions in SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: James W. Caldwell, Transportation and 
Regional Programs Division, Office of Transportation and Air Quality 
(6406J), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (202) 564-9303; fax 
number: (202) 565-2085; e-mail address: [email protected].

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 December 12, 2002 (67 FR 76399), EPA sought comments on 
this ICR pursuant to 5 CFR 1320.8(d). EPA received no comments.
    EPA has established a public docket for this ICR under Docket ID 
No. OAR-2003-0015, which is available for public viewing at the Office 
of 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 EPA Dockets (EDOCKET) 
at http://www.epa.gov/edocket. Use EDOCKET 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.
    Any comments related to this ICR should be submitted to EPA and OMB 
within 30 days of this notice, and according to the following detailed 
instructions: (1) Submit your comments to EPA online using EDOCKET (our 
preferred method), by e-mail to [email protected], or by mail to: 
EPA Docket Center, Environmental Protection Agency, Mailcode: 6102T, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001, and (2) Mail 
your comments to OMB at: Office of Information and Regulatory Affairs, 
Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 
725 17th Street, NW., Washington, DC 20503.
    EPA's policy is that public comments, whether submitted 
electronically or in paper, will be made available for public viewing 
in EDOCKET as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose public 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EDOCKET. The 
entire printed comment, including the copyrighted material, will be 
available in the public docket. Although identified as an item in the 
official docket, information claimed as CBI, or whose disclosure is 
otherwise restricted by statute, is not included in the official public 
docket, and will not be available for public viewing in EDOCKET. For 
further information about the electronic docket, see EPA's Federal 
Register notice describing the electronic docket at 67 FR 38102 (May 
31, 2002), or go to www.epa.gov/edocket.
    Title: Fuels and Fuel Additives--Health-Effects Research 
Protocols--40 CFR part 79, subpart F, (OMB Control Number 2060-0297, 
EPA ICR Number 1696.04). This is a request to renew an existing 
approved collection that is scheduled to expire on May 31, 2003. Under 
OMB regulations, the Agency may continue to conduct or sponsor the 
collection of information while this submission is pending at OMB.
    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 gasoline and diesel fuel, and 
manufacturers (including importers) of additives for gasoline or diesel 
fuel, are required to have their products registered by 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 requirement of subpart F 
(indicating how the manufacturer will satisfy the

[[Page 16021]]

research requirements) are covered by a separate ICR (EPA ICR Number 
0309.10, OMB Control Number 2060-0150). The health-effects information 
will be used to determine if there are any products whose evaporative 
or combustion emissions 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, all gasolines and gasoline 
additives which consist of only carbon, hydrogen, oxygen, nitrogen, 
and/or sulphur, and which involve a gasoline oxygen content of less 
than 1.5 weight percent, fall into a ``baseline'' group. Oxygenates, 
such as ethanol and methyl tertiary butyl ether (MTBE), when used in 
gasoline at oxygen levels 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 
sulphur fall into separate ``atypical'' groups. There are similar 
grouping requirements for diesel fuels and 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 and 
nonbaseline gasolines, diesel fuels, and additives. 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 were submitted by API and others in 1997. Tier 1 data were 
submitted for biodiesel and a water/diesel fuel emulsion in 1998 and 
2000, respectively. Tier 2 requires short-term inhalation exposures of 
laboratory animals to emissions to screen for adverse health effects. 
Alternative Tier 2 testing can be required in lieu of the standard Tier 
2 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 have been established for the API 
consortium for baseline gasoline and six gasoline-oxygenate blends. A 
similar situation exists with the Ethyl Corporation and its manganese 
additive MMT, and alternative requirements have been established. The 
API submitted Tier 2 data for diesel in 1997. Tier 2 data were 
submitted for biodiesel and a water/diesel fuel emulsion in 2000 and 
2002, respectively. Tier 3 provides for follow-up research, if 
necessary. No Tier 3 requirements have been established, and it is 
unlikely that any will be during the next three years. Thus, Tier 3 is 
not addressed in this ICR. Under section 211 of the Clean Air Act, (1) 
submission of the information is necessary for a manufacturer to obtain 
registration of a new fuel or additive, and thus be allowed to 
introduce that product into commerce, and (2) the information shall not 
be considered confidential.
    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 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 
15,175 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.
    Respondents/Affected Entities: Manufacturers of Fuels and Fuel 
Additives.
    Estimated Number of Respondents: 8.
    Frequency of Response: On occasion.
    Estimated Total Annual Hour Burden: 60,700.
    Estimated Total Annual Cost: $6.8 million, includes $1.4 million 
annualized capital or O&M costs.
    Changes in the Estimates: There is a decrease of 6,767 hours in the 
total estimated burden currently identified in the OMB Inventory of 
Approved ICR Burdens. This decrease is due to the incorrect allocation 
of hours to some of the capital/start-up costs and operating and 
maintenance costs in the previous ICR.

    Dated: March 13, 2003.
Oscar Morales,
Director, Collection Strategies Division.
[FR Doc. 03-7971 Filed 4-1-03; 8:45 am]
BILLING CODE 6560-50-P