Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Fuels and Fuel Additives-Health-Effects Research Requirements for Manufacturers; EPA ICR No. 1696.06, OMB Control No. 2060-0297, 46422-46424 [E9-21727]

Download as PDF 46422 Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Notices ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OAR–2006–0525; FRL–8953–9] Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Fuels and Fuel Additives—HealthEffects Research Requirements for Manufacturers; EPA ICR No. 1696.06, OMB Control No. 2060–0297 cprice-sewell on DSK2BSOYB1PROD with NOTICES AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. 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 February 28, 2010. 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 November 9, 2009. ADDRESSES: Submit your comments, identified by Docket ID No. EPA–HQ– OAR–2006–0525, by one of the following methods: • https://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 https:// 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 VerDate Nov<24>2008 15:47 Sep 08, 2009 Jkt 217001 protected through https:// www.regulations.gov or e-mail. The https://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 https:// 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 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 https:// 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 https:// 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 https://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 PO 00000 Frm 00016 Fmt 4703 Sfmt 4703 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 E:\FR\FM\09SEN1.SGM 09SEN1 cprice-sewell on DSK2BSOYB1PROD with NOTICES Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Notices 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. 1696.06, OMB Control No. 2060–0297. ICR status: This ICR is currently scheduled to expire on February 28, 2010. 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 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 309.12, 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 VerDate Nov<24>2008 15:47 Sep 08, 2009 Jkt 217001 ‘‘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 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 gasolineoxygenate 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, PO 00000 Frm 00017 Fmt 4703 Sfmt 4703 46423 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 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: 3. Frequency of response: On occasion. Estimated total average number of responses for each respondent: 1. Estimated total annual burden hours: 21,200. Estimated total annual costs: $2.8 million. This includes an estimated burden cost of $2.2 million and an estimated cost of $0.6 million for capital investment or maintenance and operational costs. Are There Changes in the Estimates From the Last Approval? There is a decrease of 8,950 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 MMT Alternative Tier 2 testing program noted above, and covered in the previous ICR, has completed. The API Alternative Tier 2 testing program has completed most of the testing requirements. It will have significantly reduced activity as it nears 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 E:\FR\FM\09SEN1.SGM 09SEN1 46424 Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Notices 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: September 1, 2009. Margo Tsirigotis Oge, Director, Office of Transportation and Air Quality. [FR Doc. E9–21727 Filed 9–8–09; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [FRL–8954–4] Agency Information Collection Activities OMB Responses AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: This document announces the Office of Management and Budget (OMB) responses to Agency Clearance requests, in compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). 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 regulations are listed in 40 CFR part 9 and 48 CFR chapter 15. FOR FURTHER INFORMATION CONTACT: Rick Westlund (202) 566–1682, or e-mail at westlund.rick@epa.gov and please refer to the appropriate EPA Information Collection Request (ICR) Number. SUPPLEMENTARY INFORMATION: cprice-sewell on DSK2BSOYB1PROD with NOTICES OMB Responses to Agency Clearance Requests OMB Approvals EPA ICR Number 1695.09; Emissions Certification and Compliance Requirements for Nonroad Sparkignition Engines (Renewal); 40 CFR parts 90, 1048, 1051, 1065, and 1068; was approved on 08/02/2009; OMB Number 2060–0338; expires on 08/31/ 2012; Approved without change. EPA ICR Number 2071.04; NESHAP for Printing, Coating and Dyeing of Fabrics and Other Textiles; 40 CFR part 63, subpart A; 40 CFR part 63, subpart OOOO; was approved on 08/02/2009; VerDate Nov<24>2008 15:47 Sep 08, 2009 Jkt 217001 OMB Number 2060–0522; expires on 08/31/2012; Approved without change. EPA ICR Number 2003.04; NESHAP for Integrated Iron and Steel Manufacturing; 40 CFR part 63, subpart A; 40 CFR part 63, subpart FFFFF; was approved on 08/03/2009; OMB Number 2060–0517; expires on 08/31/2012; Approved without change. EPA ICR Number 1541.09; NESHAP for Benzene Waste Operations; 40 CFR part 61, subpart FF; 40 CFR part 63, subpart A; was approved on 08/03/2009; OMB Number 2060–0183; expires on 08/31/2012; Approved without change. EPA ICR Number 2029.04; NESHAP for Asphalt Processing and Asphalt Roofing Manufacturing; 40 CFR part 63, subpart A; 40 CFR part 63, subpart LLLLL; was approved on 08/03/2009; OMB Number 2060–0520; expires on 08/31/2012; Approved without change. EPA ICR Number 2367.01; Consumer Research through Focus Groups to Develop Improved Labeling for Pesticide Products (formerly identified as EPA ICR 2297.01); 40 CFR part 156; was approved on 08/07/2009; OMB Number 2070–0175; expires on 08/31/ 2012; Approved without change. EPA ICR Number 2023.04; NESHAP for Clay Ceramics Manufacturing; 40 CFR part 60, subpart A; 40 CFR part 60, subpart KKKKK; was approved on 08/ 07/2009; OMB Number 2060–0513; expires on 08/31/2012; Approved without change. EPA ICR Number 2251.03; Control of Emissions from Nonroad Spark-Ignition Engines and Equipment (Change); 40 CFR part 1065; was approved on 08/11/ 2009; OMB Number 2060–0603; expires on 07/31/2012; Approved without change. EPA ICR Number 1292.08; Enforcement Policy Regarding the Sale and Use of Aftermarket Catalytic Converters (Renewal); 40 CFR part 85, subpart V; was approved on 08/16/2009; OMB Number 2060–0135; expires on 08/31/2012; Approved without change. EPA ICR Number 2195.03; Submission of Protocols and study Reports for Environmental Research Involving Human Subjects; 40 CFR part 26; was approved on 08/16/2009; OMB Number 2070–0169; expires on 08/31/ 2012; Approved without change. EPA ICR Number 1426.08; EPA Worker Protection Standards for Hazardous Waste Operations and Emergency Response (Renewal); 40 CFR part 311; was approved on 08/16/2009; OMB Number 2050–0105; expires on 08/31/2012; Approved without change. EPA ICR Number 2365.01; Chesapeake Action Plan/Activity Integration Plan (CAP/AIP) Reporting System; was approved on 08/17/2009; PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 OMB Number 2003–0001; expires on 02/28/2010; Approved without change. EPA ICR Number 1031.09; Recordkeeping and Reporting Requirements for Allegations of Significant Adverse Reactions to Human Health or the Environment (TSCA Section 8(c)); 40 CFR part 717; was approved on 08/19/2009; OMB Number 2070–0017; expires on 08/31/2012; Approved without change. EPA ICR Number 1938.04; NESHAP for Municipal Solid Waste Landfills; 40 CFR part 63, subpart A; 40 CFR part 63, subpart AAAA; was approved on 08/19/ 2009; OMB Number 2060–0505; expires on 08/31/2012; Approved without change. EPA ICR Number 2196.03; NSPS for Stationary Compression Ignition Internal Combustion Engines; 40 CFR part 60, subpart A; 40 CFR part 60, subpart IIII; was approved on 08/19/ 2009; OMB Number 2060–0590; expires on 08/31/2012; Approved without change. EPA ICR Number 0997.09; NSPS for Petroleum Dry Cleaners; 40 CFR part 60, subpart A; 40 CFR part 60, subpart JJJ; was approved on 08/19/2009; OMB Number 2060–0079; expires on 08/31/ 2012; Approved without change. EPA ICR Number 2344.01; Auto-Body Compliance Assessment Pilot Project (New); was approved on 08/19/2009; OMB Number 2020–0034; expires on 08/31/2012; Approved with change. EPA ICR Number 1891.05; NESHAP for Publicly Owned Treatment Works; 40 CFR part 63, subpart A; 40 CFR part 63, subpart VVV; was approved on 08/ 19/2009; OMB Number 2060–0428; expires on 08/31/2012; Approved without change. EPA ICR Number 1995.04; NESHAP for Coke Oven Pushing Quenching and Battery Stacks; 40 CFR part 63, subpart CCCCC; 40 CFR part 63, subpart A ; was approved on 08/19/2009; OMB Number 2060–0521; expires on 08/31/2012; Approved without change. EPA ICR Number 1904.05; The Sun Wise School Program (Change); was approved on 08/20/2009; OMB Number 2060–0439; expires on 02/28/2011; Approved with change. EPA ICR Number 0261.16; Notification of Regulated Waste Activity (Renewal); 40 CFR 264.11; 40 CFR 262.12; 40 CFR 263.11; 40 CFR 266.21– 266.23; 40 CFR 266.70; 40 CFR 266.80; 40 CFR 266.100–266.103; 40 CFR 266.108; 40 CFR 270.1; 40 CFR 273.54; 40 CFR 273.60; 40 CFR 279.42; 40 CFR 279.51; 40 CFR 279.62; 40 CFR 279.73; was approved on 08/20/2009; OMB Number 2050–0028; expires on 08/31/ 2012; Approved without change. E:\FR\FM\09SEN1.SGM 09SEN1

Agencies

[Federal Register Volume 74, Number 173 (Wednesday, September 9, 2009)]
[Notices]
[Pages 46422-46424]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-21727]



[[Page 46422]]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2006-0525; FRL-8953-9]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Registration of Fuels and Fuel Additives--Health-
Effects Research Requirements for Manufacturers; EPA ICR No. 1696.06, 
OMB Control No. 2060-0297

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

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 February 28, 2010. 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 November 9, 2009.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2006-0525, by one of the following methods:
     https://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 
https://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 https://www.regulations.gov or e-mail. The https://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 https://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 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 https://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 
https://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 https://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

[[Page 46423]]

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. 1696.06, OMB Control No. 2060-0297.
    ICR status: This ICR is currently scheduled to expire on February 
28, 2010. 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 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 309.12, 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 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 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: 3.
    Frequency of response: On occasion.
    Estimated total average number of responses for each respondent: 1.
    Estimated total annual burden hours: 21,200.
    Estimated total annual costs: $2.8 million. This includes an 
estimated burden cost of $2.2 million and an estimated cost of $0.6 
million for capital investment or maintenance and operational costs.

Are There Changes in the Estimates From the Last Approval?

    There is a decrease of 8,950 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 MMT Alternative Tier 2 testing program noted above, and 
covered in the previous ICR, has completed. The API Alternative Tier 2 
testing program has completed most of the testing requirements. It will 
have significantly reduced activity as it nears 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

[[Page 46424]]

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: September 1, 2009.
Margo Tsirigotis Oge,
Director, Office of Transportation and Air Quality.
[FR Doc. E9-21727 Filed 9-8-09; 8:45 am]
BILLING CODE 6560-50-P
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