[Federal Register Volume 81, Number 72 (Thursday, April 14, 2016)]
[Notices]
[Pages 22080-22081]
[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<EMAIL_ADDRESS>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:<PHONE_NUMBER>; fax number:
(202) 343-2800; email address<EMAIL_ADDRESS>
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<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.

    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]
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