[Federal Register: August 12, 1999 (Volume 64, Number 155)] [Notices] [Page 44006-44007] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr12au99-57] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [FRL-6418-5] Agency Information Collection Activities: Submission for OMB Review; Comment Request, Registration of Fuels and Fuel Additives-- Health-Effects Research Requirements AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. ----------------------------------------------------------------------- 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: Registration of Fuels and Fuel Additives: Health-effects Research Requirements for Manufacturers (40 CFR part 79--subpart F) (OMB Control Number 2060-0297, expiration date: October 31, 1999). The ICR describes the nature of the information collection and its expected burden and cost; where appropriate, it includes the actual data collection instrument. DATES: Comments must be submitted on or before September 13, 1999. FOR FURTHER INFORMATION CONTACT: Sandy Farmer at EPA by phone at (202) 260-2740, by E-Mail at Farmer.Sandy@epamail.epa.gov or download a copy of the ICR off the Internet at http://www.epa.gov/icr and refer to EPA ICR No. 1696.03. SUPPLEMENTARY INFORMATION: [[Page 44007]] 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 October 31, 1999. This is a request for an extension of a currently approved collection. Abstract: In accordance with the Clean Air Act regulations at 40 CFR part 79, manufacturers (including importers) of gasoline, diesel fuel, and additives for gasoline or diesel fuel, are required to have their products registered by the 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 health-effects research is the subject of this ICR. The other information collection requirements at 40 CFR part 79 are covered by a separate ICR (EPA ICR Number 309.09, OMB Control Number 2060-1050). The health-effects research is divided into three tiers of requirements for specific categories of fuels and additives. Tier 1 requires an emissions characterization and a health-effects literature search for those emissions. Tier 1 data were submitted in 1997 and 1998 and will be applicable for most new products seeking registration. Tier 2 requires short-term inhalation exposures of laboratory animals to emissions to screen for adverse health effects, unless comparable data are already available. Alternative Tier 2 testing can be required in lieu of the standard Tier 2 if EPA concludes that such testing would be more appropriate. EPA reached that conclusion with respect to baseline gasoline, oxygenated gasoline additives, and Ethyl Corporation's manganese gasoline additive MMT. Certain small businesses are exempt from some or all of the Tier 1 and Tier 2 requirements. Tier 3 provides for follow-up research, if necessary. However, no Tier 3 requirements have been established. Thus, it is not covered in this document. This information will be used to determine if there are any products whose evaporative or combustion emissions may pose an unreasonable risk to public health, thus meriting further investigation and potential regulation. In accordance with the Clean Air Act, the results of this research 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 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 Federal Register document required under 5 CFR 1320.8(d), soliciting comments on this collection of information, was published on April 7, 1999 (64 FR 16960); one comment was received. It was a brief statement from the Ethyl Corporation referencing the continuing dialogue over the appropriate testing for MMT. Burden Statement: It is likely that only limited additional Tier 1 research will be done. New fuels and additives subject to Tier 1 will almost exclusively be those that can group with existing Tier 1 data, and come from manufacturers that have already paid for the Tier 1 data. Thus, over the next three years only one Tier 1 submission is anticipated. Standard Tier 2 activity will also be very limited. The EPA has concluded that existing data cover Tier 2 for baseline diesel. Alternative Tier 2 testing will be conducted over the next five years and covers baseline gasoline, the six major nonbaseline gasoline oxygenates, and the atypical gasoline additive MMT. Thus, only up to four standard Tier 2 submissions are anticipated over the next three years. The annual public reporting and recordkeeping burden for this collection is estimated to average 20,695 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 gasoline, diesel fuel, and fuel additives. Estimated Number of Respondents: 6. Frequency of Response: On occasion. Estimated Total Annual Hour Burden: 67,467 hours. Estimated Total Annualized Capital, O & M Cost Burden: $6.5 million. Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, to the following addresses. Please refer to EPA ICR Number 1696.03 and OMB Control Number 2060-0297 in any correspondence. Ms. Sandy Farmer, U.S. Environmental Protection Agency, Office of Policy, Regulatory Information Division (2137), 401 M Street, SW, Washington, DC 20460; and Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for EPA, 725 17th Street, NW, Washington, DC 20503. Dated: August 6, 1999. Richard T. Westlund, Acting Director, Regulatory Information Division. [FR Doc. 99-20864 Filed 8-11-99; 8:45 am] BILLING CODE 6560-50-P