Document ID: EPA-HQ-OAR-2006-0525-0001
Agency: epa
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Fuels and Fuel Additives--Health- Effects Research Requirements for Manufacturers; EPA ICR No. 1696.05, OMB Control No. 2060-0297
Posted Date: 2006-07-17T12:46:09Z

[Federal Register: July 17, 2006 (Volume 71, Number 136)]
[Notices]               
[Page 40513-40515]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17jy06-66]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2006-0525; FRL-8198-4]

 
Agency Information Collection Activities; Proposed Collection; 
Comment Request; Registration of Fuels and Fuel Additives--Health-
Effects Research Requirements for Manufacturers; 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 EPA is planning to 
submit a request to renew an existing approved Information Collection 
Request (ICR) to the Office of Management and Budget (OMB). This ICR is 
scheduled to expire on November 30, 2006. 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.

DATES: Comments must be submitted on or before September 15, 2006.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2006-0525, by one of the following methods:
     http://www.regulations.gov: Follow the on-line instructions for 

submitting comments.
     E-mail: a-and-r-docket@epa.gov.
     Fax: (202) 566-1741.
     Mail: Air and Radiation Docket, Docket ID No. EPA-HQ-OAR-
2006-0525, Environmental Protection Agency, Mailcode: 6102T, 1200 
Pennsylvania Avenue, NW., Washington, DC 20460.
     Hand Delivery: EPA Docket Center, Room B102, EPA West 
Building, 1301 Constitution Avenue, NW., Washington, DC 20460. Such 
deliveries are only accepted during the Docket's normal hours of 
operation, and special arrangements should be made for deliveries of 
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2006-0525. EPA's policy is that all comments received will be included 
in the public docket without change and may be made available online at 
http://www.regulations.gov, including any personal information provided, 

unless the comment includes information claimed to be Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Do not submit information that you consider to 
be CBI or otherwise protected through http://www.regulations.gov or e-mail. 

The http://www.regulations.gov Web site is an ``anonymous access'' system, 

which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through http://www.regulations.gov 

your e-mail address will be automatically captured and included as part 
of the comment that is placed in the public docket and made available 
on the Internet. If you submit an electronic comment, EPA recommends 
that you include your name and other contact information in the body of 
your comment and with any disk or CD-ROM

[[Page 40514]]

you submit. If EPA cannot read your comment due to technical 
difficulties and cannot contact you for clarification, EPA may not be 
able to consider your comment. Electronic files should avoid the use of 
special characters, any form of encryption, and be free of any defects 
or viruses. For additional information about EPA's public docket visit 
the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm
.

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:

How Can I Access the Docket and/or Submit Comments?

    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 B102, 1301 
Constitution Avenue, 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 is 202-
566-1742.
    Use http://www.regulations.gov to obtain a copy of the draft collection of 

information, submit or view public comments, access the index listing 
of the contents of the docket, and to access those documents in the 
public docket that are available electronically. Once in the system, 
select ``search,'' then key in the docket ID number identified in this 
document.

What Information Is EPA Particularly Interested in?

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically 
solicits comments and information to enable it 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. In particular, EPA is requesting comments from 
very small businesses (those that employ less than 25) on examples of 
specific additional efforts that EPA could make to reduce the paperwork 
burden for very small businesses affected by this collection.

What Should I Consider When I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible and provide specific 
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Offer alternative ways to improve the collection activity.
    6. Make sure to submit your comments by the deadline identified 
under DATES.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

What Information Collection Activity or ICR Does This Apply to?

    Affected entities: Entities potentially affected by this action are 
the manufacturers of motor-vehicle gasoline, motor-vehicle diesel fuel, 
and additives for those fuels.
    Title: Registration of Fuels and Fuel Additives--Health-Effects 
Research Requirements for Manufacturers.
    ICR numbers: EPA ICR No. 1696.05, OMB Control No. 2060-0297.
    ICR status: This ICR is currently scheduled to expire on November 
30, 2006. 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 Number 309.11, OMB Control Number 
2060-1050). 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 and ethyl 
tertiary butyl ether, when used in gasoline at 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 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

[[Page 40515]]

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.
    The ICR provides a detailed explanation of the Agency's estimate, 
which is only briefly summarized here:
    Estimated total number of potential respondents: 4.
    Frequency of response: On occasion.
    Estimated total average number of responses for each respondent: 1.
    Estimated total annual burden hours: 30,150.
    Estimated total annual costs: $3.2 million. This includes an 
estimated burden cost of $2.5 million and an estimated cost of $0.7 
million for capital investment or maintenance and operational costs.

Are There Changes in the Estimates From the Last Approval?

    There is a decrease of 30,550 hours in the total estimated annual 
respondent burden compared with that identified in the ICR currently 
approved by OMB. This decrease reflects EPA's updating of burden 
estimates. The two Alternative Tier 2 testing programs noted above, and 
covered in the previous ICR, have completed most of the testing 
requirements. They will have significantly reduced activity as the 
programs near completion over the next three years. Although there will 
likely be new fuels and additives for which testing will be required, 
such testing is not expected to be as extensive as the two programs 
noted above.

What Is the Next Step in the Process for This ICR?

    EPA will consider the comments received and amend the ICR as 
appropriate. The final ICR package will then be submitted to OMB for 
review and approval pursuant to 5 CFR 1320.12. At that time, EPA will 
issue another Federal Register notice pursuant to 5 CFR 
1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the 
opportunity to submit additional comments to OMB. If you have any 
questions about this ICR or the approval process, please contact the 
technical person listed under FOR FURTHER INFORMATION CONTACT.

    Dated: July 11, 2006.
Margo Tsirigotis Oge,
Director, Office of Transportation and Air Quality.
 [FR Doc. E6-11257 Filed 7-14-06; 8:45 am]

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