[Federal Register Volume 64, Number 66 (Wednesday, April 7, 1999)]
[Notices]
[Pages 16960-16961]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-8632]
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ENVIRONMENTAL PROTECTION AGENCY
[FRL-6320-6]
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 1696.03, OMB Control Number
2060-0297, expiration date: 7-31-99). 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 June 7, 1999.
ADDRESSES: Fuels and Energy Division, Office of Mobile Sources, Office
of Air and Radiation, Mail Code 6406J, U.S. Environmental Protection
Agency, Washington, DC 20460. 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 1696.03, Expiring: 7-31-
99.
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 research
requirements) are covered by a separate ICR (EPA ICR Number 309.09, 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 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 proposed. The API submitted Tier 2 data for
diesel in 1997. 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
[[Page 16961]]
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 200 fuel manufacturers,
700 additive manufacturers, 600 registered fuels, and 5500 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 $0.5
million per product, and that there will be only one Tier 1 submission
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 million per product, and that
there will only be four standard Tier 2 submissions 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: March 25, 1999.
John W. Holley,
Acting Director, Fuels and Energy Division.
[FR Doc. 99-8632 Filed 4-6-99; 8:45 am]
BILLING CODE 6560-50-P