Document ID: EPA-HQ-OAR-2006-0525-0003
Agency: epa
Document Type: Notice
Title: Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; Fuels and Fuel Additives: Health- Effects Research Protocols (Renewal); EPA ICR No. 1696.05, OMB Control No. 2060-0297
Posted Date: 2006-11-06T16:39:59Z

[Federal Register: November 6, 2006 (Volume 71, Number 214)]
[Notices]               
[Page 64950-64951]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06no06-29]                         

[[Page 64950]]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2006-0525; FRL-8240-2]

 
Agency Information Collection Activities; Submission to OMB for 
Review and Approval; Comment Request; Fuels and Fuel Additives: Health-
Effects Research Protocols (Renewal); EPA ICR No. 1696.05, 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 December 6, 
2006.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OAR-
2006-0525, to (1) EPA online using http://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, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and (2) OMB 
by mail to: Office of Information and Regulatory Affairs, Office of 
Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th 
Street, NW., Washington, DC 20503.

    Note: The EPA Docket Center suffered damage due to flooding 
during the last week of June 2006. The Docket Center is continuing 
to operate. However, during the cleanup, there will be temporary 
changes to Docket Center telephone numbers, addresses, and hours of 
operation for people who wish to visit the Public Reading Room to 
view documents. Consult EPA's Federal Register notice at 71 FR 38147 
(July 5, 2006) or the EPA Web site at http://www.epa.gov/epahome/dockets.htm
 for current information on docket status, locations and 

telephone numbers.

FOR FURTHER INFORMATION CONTACT: James W. Caldwell, Office of 
Transportation and Air Quality, Mailcode: 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 July 17, 2006 (71 FR 40513), 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 and Information Center in the EPA Docket Center (EPA/
DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. 
The EPA/DC Public Reading Room is open from 8 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 and Information Center 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, 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 Protocols 
(Renewal).
    ICR Numbers: EPA ICR No. 1696.05, OMB Control No. 2060-0297.
    ICR Status: This ICR is scheduled to expire on November 30, 2006. 
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, 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 (EPA ICR No. 0309.11, OMB Control No. 2060-
0150). The health-effects data will be used to determine if there are 
any products which 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,

[[Page 64951]]

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, and several 
atypical additives. 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 7,538 
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 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: 4.
    Frequency of Response: On Occasion.
    Estimated Total Annual Hour Burden: 30,150.
    Estimated Total Annual Cost: $3.2 million, includes $757,000 
annualized capital and O&M costs.
    Changes in the Estimates: There is a decrease of 30,550 hours in 
the total estimated burden currently identified in the OMB Inventory of 
Approved ICR Burdens. This decrease is the result of reduced activity 
as the two alternative Tier 2 testing programs near completion.

    Dated: October 30, 2006.
Oscar Morales,
Director, Collection Strategies Division.
[FR Doc. E6-18658 Filed 11-3-06; 8:45 am]

BILLING CODE 6560-50-P