Agency Information Collection Activities: Submission for OMB Review; Comment Request, Registration of Fuels and Fuel Additives Health-Effects Research Requirements

[Federal Register Volume 64, Number 155 (Thursday, August 12, 1999)]
[Notices]
[Pages 44006-44007]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20864]


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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.

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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