
[Federal Register Volume 75, Number 5 (Friday, January 8, 2010)]
[Notices]
[Pages 1055-1057]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: X10-310108]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2006-0525; FRL-9101-2]


Agency Information Collection Activities; Submission to OMB for 
Review and Approval; Comment Request; Fuels and Fuel Additives: Health-
Effects Research Requirements for Manufacturers (Renewal); EPA ICR No. 
1696.06, OMB Control No. 2060-0297

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44 
U.S.C. 3501 et seq.), this document announces that an Information 
Collection Request (ICR) has been forwarded to the Office of Management 
and Budget (OMB) for review and approval. This is a request to renew an 
existing approved collection. The ICR, which is abstracted below, 
describes the nature of the information collection and its estimated 
burden and cost.

DATES: Additional comments may be submitted on or before February 8, 
2010.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OAR-
2006-0525, to (1) EPA online using www.regulations.gov (our preferred 
method), by e-mail to a-and-r-docket@epa.gov, or by mail to: EPA Docket 
Center, Environmental Protection Agency, Air and Radiation Docket, 
Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, 
and (2) OMB by mail to:

[[Page 1056]]

Office of Information and Regulatory Affairs, Office of Management and 
Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., 
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: James W. Caldwell, Office of 
Transportation and Air Quality, Mail code: 6406J, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (202) 343-9303; fax number: (202) 343-2802; e-mail 
address: caldwell.jim@epa.gov.

SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB 
for review and approval according to the procedures prescribed in 5 CFR 
1320.12. On September 9, 2009 (74 FR 46422), EPA sought comments on 
this ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any 
additional comments on this ICR should be submitted to EPA and OMB 
within 30 days of this notice.
    EPA has established a public docket for this ICR under Docket ID 
No. EPA-HQ-OAR-2006-0525, which is available for online viewing at 
http://www.regulations.gov, or in person viewing at the Air and 
Radiation Docket in the EPA Docket Center (EPA/DC), EPA West, Room 
3334, 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Reading 
Room is 202-566-1744, and the telephone number for the Air and 
Radiation Docket is 202-566-1742.
    Use EPA's electronic docket and comment system at http://
www.regulations.gov, to submit or view public comments, access the 
index listing of the contents of the docket, and to access those 
documents in the docket that are available electronically. Once in the 
system, select ``docket search,'' then key in the docket ID number 
identified above. Please note that EPA's policy is that public 
comments, whether submitted electronically or in paper, will be made 
available for public viewing at http://www.regulations.gov as EPA 
receives them and without change, unless the comment contains 
copyrighted material, confidential business information (CBI), or other 
information whose public disclosure is restricted by statute. For 
further information about the electronic docket, go to http://
www.regulations.gov.
    Title: Fuels and Fuel Additives: Health-Effects Research 
Requirements for Manufacturers (Renewal).
    ICR numbers: EPA ICR No. 1696.06, OMB Control No. 2060-0297.
    ICR Status: This ICR is scheduled to expire on February 28, 2010. 
Under OMB regulations, the Agency may continue to conduct or sponsor 
the collection of information while this submission is pending at OMB. 
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 
in title 40 of the CFR, after appearing in the Federal Register when 
approved, are listed in 40 CFR Part 9, and are displayed either by 
publication in the Federal Register or by other appropriate means, such 
as on the related collection instrument or form, if applicable. The 
display of OMB control numbers in certain EPA regulations is 
consolidated in 40 CFR Part 9.
    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 motor-vehicle gasoline, motor-
vehicle diesel fuel, and additives for those fuels, are required to 
have these 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 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 requirements of Subpart F (indicating how the 
manufacturer will satisfy the health-effects data requirements) are 
covered by a separate ICR (OMB Control No. 2060-0150). The health-
effects data will be used to determine if there are any products that 
have evaporative or combustion emissions that may 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, 
gasoline and gasoline additives which consist of only carbon, hydrogen, 
oxygen, nitrogen and/or sulfur, and which involve a gasoline oxygen 
content of less than 1.5 weight percent, fall into a ``baseline'' 
group. Oxygenates, such as ethanol, when used in gasoline as an oxygen 
level 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 sulfur fall into separate 
atypical groups. There are similar grouping requirements for diesel 
fuel and diesel fuel 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 
gasoline, baseline diesel fuel, baseline fuel additives, and the 
prominent nonbaseline oxygenated additives for gasoline. 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 for gasoline and diesel fuel were submitted by API and others in 
1997. Tier 1 data have been submitted for biodiesel, water/diesel 
emulsions, several atypical additives, and renewable diesel fuels. Tier 
2 requires short-term inhalation exposures of laboratory animals to 
emissions to screen for adverse health effects. Tier 2 data have been 
submitted for baseline diesel, biodiesel, and water/diesel emulsions. 
Alternative Tier 2 testing can be required in lieu of standard Tier 2 
testing 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 were established for the 
API consortium for baseline gasoline and six gasoline-oxygenate blends. 
Alternative Tier 2 requirements have also been established for the 
manganese additive MMT manufactured by the Afton Chemical Corporation 
(formerly the Ethyl Corporation). Tier 3 provides for follow-up 
research, at EPA's discretion, when remaining uncertainties as to the 
significance of observed health effects, welfare effects, and/or 
emissions exposures from a fuel or fuel/additive mixture interfere with 
EPA's ability to make reasonable estimates of the potential risks posed 
by emissions from a fuel or additive. To date, EPA has not imposed any 
Tier 3 requirements. Under Section 211 of the Clean Air Act, (1) 
submission of the health-effects information is necessary for a 
manufacturer to obtain registration of a motor-vehicle gasoline, diesel 
fuel, or fuel additive, and thus be allowed to introduce that product 
into commerce, and (2) the information shall not be considered 
confidential.
    Burden Statement: The annual public reporting and recordkeeping 
burden for this collection of information is estimated to average 7,067 
hours per

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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 
which have subsequently changed; 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 Fuels and Fuel 
Additives.
    Estimated Number of Respondents: 3.
    Frequency of Response: On Occasion.
    Estimated Total Annual Hour Burden: 21,200.
    Estimated Total Annual Cost: $2,831,480, which includes $2,244,480 
in labor costs, $205,000 in capital costs and $382,000 in O&M costs.
    Changes in the Estimates: There is a decrease of 8,950 hours in the 
total estimated burden currently identified in the OMB Inventory of 
Approved ICR Burdens. This decrease is the result of reduced activity 
with the completion of the MMT alternative Tier 2 testing program the 
near completion of the oxygenate alternative Tier 2 testing program.

    Dated: December 24, 2009.
Richard T. Westlund,
Acting Director, Collection Strategies Division.
[FR Doc. 2010-150 Filed 1-7-10; 8:45 am]
BILLING CODE 6560-50-P


