Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Fuels and Fuel Additives: Health-Effects Research Requirements for Manufacturers (Renewal) Publication: Federal Register Agency: Environmental Protection Agency Byline: Courtney Kerwin Date: 20 March 2024 Subjects: American Government , The Environment, Petroleum

[Federal Register Volume 89, Number 55 (Wednesday, March 20, 2024)]
[Notices]
[Pages 19822-19823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05931]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2006-0525; FRL-11844-01-OMS]


Agency Information Collection Activities; Submission to the 
Office of Management and Budget for Review and Approval; Comment 
Request; 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 (EPA) has submitted an 
information collection request (ICR), Fuels and Fuel Additives: Health-
Effects Research Requirements for Manufacturers (EPA ICR Number. 
1696.11, OMB Control Number 2060-0297) to the Office of Management and 
Budget (OMB) for review and approval in accordance with the Paperwork 
Reduction Act. This is a proposed extension of the ICR, which is 
currently approved through March 31, 2024. Public comments were 
previously requested via the Federal Register on July 5, 2023, during a 
60-day comment period. This notice allows for 30 days for public 
comments.

DATES: Comments may be submitted on or before April 19, 2024.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OAR-2006-0525, to 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. 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

[[Page 19823]]

Business Information (CBI) or other information whose disclosure is 
restricted by statute. Submit written comments and recommendations to 
OMB for the proposed information collection within 30 days of 
publication of this notice to www.reginfo.gov/public/do/PRAMain. Find 
this particular information collection by selecting ``Currently under 
30-day Review--Open for Public Comments'' or by using the search 
function.

FOR FURTHER INFORMATION CONTACT: James W. Caldwell, Compliance 
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) 343-2800; 
email address: caldwell.jim@epa.gov.

SUPPLEMENTARY INFORMATION: This is a proposed extension of the ICR, 
which is currently approved through March 31, 2024. 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.
    Public comments were previously requested via the Federal Register 
on July 5, 2023 during a 60-day comment period (88 FR 42939). This 
notice allows for an additional 30 days for public comments. 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.
    Abstract: In accordance with the regulations at 40 CFR 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 (OMB Control Number 2060-0150). 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 ``non-
baseline'' 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 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. 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 requirements were 
established for the API consortium for baseline gasoline and six 
gasoline-oxygenate blends. 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. Under regulations promulgated pursuant to 
Section 211 of the Clean Air Act, 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 be allowed 
to introduce that product into commerce and 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 79.
    Estimated number of respondents: 2.
    Frequency of response: On occasion.
    Total estimated burden: 13,867 hours per year. Burden is defined at 
5 CFR 1320.03(b).
    Total estimated cost: $1.7 million per year, includes $0.6 million 
annualized capital or operation & maintenance costs.
    Changes in the Estimates: There is a $2 million decrease in cost. 
This is due to an estimated decrease in the number of fuels and 
additives for which testing will be required.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2024-05931 Filed 3-19-24; 8:45 am]
BILLING CODE 6560-50-P