[Federal Register Volume 67, Number 239 (Thursday, December 12, 2002)]
[Notices]
[Pages 76399-76400]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-31360]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-7420-7]


Agency Information Collection Activities: Continuing Collection; 
Comment Request; Registration of Fuels and Fuel Additives--Health-
Effects Research Requirements for Manufacturers

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 notice announces that EPA is planning to submit the 
following continuing Information Collection Request (ICR) to the Office 
of Management and Budget (OMB): Registration of Fuels and Fuel 
Additives--Health-effects Research Requirements for Manufacturers (40 
CFR part 79, subpart F) (EPA ICR Number 1696.04, OMB Control Number 
2060-0297, expiration date: 5-31-03). 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 February 10, 2003.

ADDRESSES: Transportation and Regional Programs Division, Office of 
Transportation and Air Quality, Office of Air and Radiation, Mail Code 
6406J, U.S. Environmental Protection Agency, Washington, DC 20460-0001. 
A paper or electronic copy of the ICR may be obtained without charge by 
contacting the person listed below.

FOR FURTHER INFORMATION CONTACT: James W. Caldwell, (202) 564-9303, 
fax: (202) 565-2085, [email protected].

SUPPLEMENTARY INFORMATION:
    Affected entities: Entities potentially affected by this action are 
those which manufacture or import gasoline or diesel fuel, or 
manufacture or import an additive for gasoline or diesel fuel.
    Title: Registration of Fuels and Fuel Additives--Health-effects 
Research Requirements for Manufacturers (40 CFR part 79, subpart F), 
OMB Control Number 2060-0297, EPA ICR Number 1696.04, Expiring: 5-31-
03.
    Abstract: In accordance with the regulations at 40 CFR part 79, 
subparts

[[Page 76400]]

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 research requirements) are covered by 
a separate ICR (EPA ICR Number 309.10, OMB Control Number 2060-1050). 
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. 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.
    The EPA would like to solicit comments 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.
    Burden Statement: There are approximately 150 fuel manufacturers, 
650 additive manufacturers, 600 registered fuels, and 5700 registered 
additives. Due to the costs, it is likely that only limited additional 
Tier 1 research will be done. Future fuels and additives will almost 
exclusively be those that can group with existing Tier 1 data, and 
likely will come from manufacturers that have already paid for the Tier 
1 research. It is estimated that new Tier 1 research will cost $0.35 
million per product, and that there will be only one Tier 1 submission 
per year over the next three years. Standard Tier 2 activity also will 
be very limited. The EPA has concluded that existing data cover 
standard Tier 2 for baseline diesel. Baseline gasoline, the six major 
nonbaseline gasoline oxygenates, and the atypical gasoline additive 
MMT, are subject to alternative Tier 2 requirements. It is estimated 
that new standard Tier 2 research will cost $1.5 million per product, 
and that there will be only one standard Tier 2 submission per year 
over the next three years. It is estimated that the alternative Tier 2 
testing for gasoline and oxygenates will cost $15 million over five 
years. It is estimated that the alternative Tier 2 testing for MMT will 
cost $10 million over five years. 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.

    Dated: December 4, 2002.
Deborah K. Wood,
Acting Director, Transportation and Regional Programs Division.
[FR Doc. 02-31360 Filed 12-11-02; 8:45 am]
BILLING CODE 6560-50-P