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


[Notices]               
[Page 63544-63545]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01de97-78]

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ENVIRONMENTAL PROTECTION AGENCY
[FRL-5930-4]
 
Agency Information Collection Activities: Continuing Collection; 
Comment Request; Registration of Fuels and Fuel Additives--Health-
effects Research Requirements

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 (EPA 
ICR Number 1696.02, OMB Control Number 2060-0297, expiration date: 1-
31-98). 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 January 30, 1998.

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, caldwell.jim@epamail.epa.gov.

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

OMB Control Number 2060-0297
EPA ICR Number 1696.02
Expiring: 1-31-98

    Abstract: In accordance with the regulations at 40 CFR 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) if 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 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

[[Page 63545]]

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. 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 a health-effects literature search and emissions 
characterization. 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 
has reached that conclusion with respect to gasoline and gasoline-
oxygenate blends, and the API consortium has been notified. However, 
the alternative requirements have not been finalized, and thus are not 
part of this ICR. A similar situation exists with the Ethyl Corporation 
and its manganese additive MMT. This ICR will be amended once those 
requirements are finalized. 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 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 100 fuel manufacturers, 
1300 additive manufacturers, 800 registered fuels, and 6000 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 $500,000 
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 Tier 2 for baseline 
diesel. Alternative Tier 2 requirements for baseline gasoline, the six 
major nonbaseline gasoline oxygenates, and the atypical gasoline 
additive MMT, are not covered by this ICR. It is estimated that new 
Tier 2 research will cost $500,000 per product, and that there will 
only be one Tier 2 submission over the next three 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: November 24, 1997.
Charles N. Freed,
Director, Fuels and Energy Division.

[FR Doc. 97-31407 Filed 11-28-97; 8:45 am]
BILLING CODE 6560-50-P

 
 

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