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

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Environmental Protection Agency (EPA).




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.


Comments must be submitted on or before February 10, 2003.


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.

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James W. Caldwell, (202) 564-9303, fax: (202) 565-2085,

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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 Start Printed Page 76400A, 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.

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Dated: December 4, 2002.

Deborah K. Wood,

Acting Director, Transportation and Regional Programs Division.

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[FR Doc. 02-31360 Filed 12-11-02; 8:45 am]