Proposed Information Collection Request; Comment Request; Registration of Fuels and Fuel Additives--Health-Effects Research Requirements for Manufacturers; EPA ICR No. 1696.09, OMB Control No. 2060-0297

Byron J. Bunker
Environmental Protection Agency
14 April 2016

[Federal Register Volume 81, Number 72 (Thursday, April 14, 2016)]
[Notices]
[Pages 22080-22081]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08628]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2006-0525; FRL-9944-97-OAR]


Proposed Information Collection Request; Comment Request; 
Registration of Fuels and Fuel Additives--Health-Effects Research 
Requirements for Manufacturers; EPA ICR No. 1696.09, OMB Control No. 
2060-0297

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency is planning to submit an 
Information Collection Request (ICR), Registration of Fuels and Fuel 
Additives--Health-Effects Research Requirements for Manufacturers, EPA 
ICR No. 1696.09, OMB Control No. 2060-0297, to the Office of Management 
and Budget (OMB) for review and approval in accordance with the 
Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.). Before doing 
so, EPA is soliciting public comments on specific aspects of the 
proposed information collection as described below. This is a proposed 
extension of the ICR, which is currently approved through September 30, 
2016. 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.

DATES: Comments must be submitted on or before June 13, 2016.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OAR-
2006-0525, 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.
    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 
Division, 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) 343-2800; 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 or in person at the EPA Docket Center, WJC West, 
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone 
number for the Docket Center is 202-566-1744. For additional 
information about EPA's public docket, visit http://www.epa.gov/dockets.

[[Page 22081]]

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting 
comments and information to enable it to: (1) 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; (2) 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; (3) enhance the quality, utility, and clarity of the information 
to be collected; and (4) 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. 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. At that 
time, EPA will issue another Federal Register notice to announce the 
submission of the ICR to OMB and the opportunity to submit additional 
comments to OMB.
    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 309.14, 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. Oxygenated additives, such as ethanol, 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 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 
regulations promulgated pursuant to 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: 17,600 hours per year. Burden is defined at 
5 CFR 1320.03(b).
    Total estimated cost: $2 million per year, includes $0.6 million 
annualized capital or operation & maintenance costs.
    Changes in Estimates: There is a decrease of 1,600 hours in the 
total estimated respondent burden compared with the ICR currently 
approved by OMB. This decrease is due to a revision in the estimate for 
conducting the Tier 1 literature search.

    Dated: April 7, 2016.
Byron J. Bunker,
Director, Compliance Division, Office of Transportation and Air 
Quality, Office of Air and Radiation.
[FR Doc. 2016-08628 Filed 4-13-16; 8:45 am]
 BILLING CODE 6560-50-P