Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Registration of Fuels and Fuel Additives: Health-Effects Research Requirements for Manufacturers (Renewal)

John Moses
Environmental Protection Agency
July 9, 2013

[Federal Register Volume 78, Number 131 (Tuesday, July 9, 2013)]
[Notices]
[Pages 41059-41060]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-16426]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2006-0525; FRL 9532-7]


Information Collection Request Submitted to OMB for Review and 
Approval; Comment Request; Registration of Fuels and Fuel Additives: 
Health-Effects Research Requirements for Manufacturers (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency has submitted an 
information collection request (ICR), Registration of Fuels and Fuel 
Additives: Health-Effects Research Requirements for Manufacturers 
(Renewal) (EPA ICR No. 1696.07, OMB Control No. 2060-0297) to the 
Office of Management and Budget (OMB) for review and approval in 
accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). 
This is a proposed extension of the ICR, which is currently approved 
through August 31, 2013. Public comments were previously requested via 
the Federal Register (78 FR 11869) on February 20, 2013 during a 60-day 
comment period. This notice allows for an additional 30 days for public 
comments. A fuller description of the ICR is given below, including its 
estimated burden and cost to the public. An Agency may not conduct or 
sponsor and a person is not required to respond to a collection for 
information unless it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before August 8, 
2013.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OAR-2006-0525, to (1) EPA online using www.regulations.gov (our 
preferred method), by email to a-and-r-docket@epa.gov, or by mail to: 
EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 
1200 Pennsylvania Ave. NW., Washington, DC 20460, and (2) OMB via email 
to oira_submission@omb.eop.gov. Address comments to OMB Desk Officer 
for EPA.
    EPA's policy is that all comments received will be included in the 
public docket without change including any personal information 
provided, unless the comment includes profanity, threats, information 
claimed to be Confidential Business Information (CBI) or other 
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: James W. Caldwell, Compliance

[[Page 41060]]

Division, 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; email address: caldwell.jim@epa.gov.

SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail 
the information that the EPA will be collecting are available in the 
public docket for this ICR. The docket can be viewed online at 
www.regulations.gov on in person at the EPA Docket Center, EPA West, 
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone 
number for the Docket Center is 202-566-1744. For further information 
about EPA's public docket, visit http://www.epa.gov/dockets.
    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 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.
    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 non-baseline 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 gasoline and 
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. 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.
    Form Numbers: None.
    Respondents/affected entities: Manufacturers of motor-vehicle 
gasoline, motor-vehicle diesel fuel, and additives for those fuels.
    Respondent's obligation to respond: Mandatory per 40 CFR part 79.
    Estimated number of respondents: 2.
    Frequency of response: On occasion.
    Total Estimated Burden: 19,200 hours per year. Burden is defined at 
5 CFR 1320.3(b).
    Total Estimated Cost: $2,078,280 per year, which includes $537,000 
in annualized capital or operation & maintenance costs.
    Changes in Estimates: There is a decrease 2,000 hours in the total 
estimated respondent burden compared with the ICR currently approved by 
OMB. This decrease is due to the completion of a testing program 
included in the previous ICR.

John Moses,
Director, Collection Strategies Division.
[FR Doc. 2013-16426 Filed 7-8-13; 8:45 am]
BILLING CODE 6560-50-P