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)

Courtney Kerwin
Environmental Protection Agency
26 September 2019

[Federal Register Volume 84, Number 187 (Thursday, September 26, 2019)]
[Notices]
[Pages 50826-50827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20947]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2006-0525; FRL-9998-35-OMS]


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 (EPA) has submitted an 
information collection request (ICR), Registration of Fuels and Fuel 
Additives: Health-Effects Research Requirements for Manufacturers (EPA 
ICR Number 1696.10, 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 November 30, 2019. Public comments 
were previously requested via the Federal Register on May 21, 2019 
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 of information unless it displays a currently valid OMB 
control number.

DATES: Additional comments may be submitted on or before October 28, 
2019.

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 
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: 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 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

[[Page 50827]]

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 79, 
subpart F.
    Estimated number of respondents: 2.
    Frequency of response: On occasion.
    Total estimated burden: 35,200 hours per year. Burden is defined at 
5 CFR 1320.03(b).
    Total estimated cost: $3,697,000 per year, includes $597,000 
annualized capital or operation & maintenance costs.
    Changes in the Estimates: There is an increase of 17,600 hours in 
the total estimated respondent burden compared with the ICR currently 
approved by OMB. This increase is based on input from an industry 
representative who stated that their actual literature review and Tier 
2/Alternative Tier 2 costs were double the EPA estimate.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2019-20947 Filed 9-25-19; 8:45 am]
 BILLING CODE 6560-50-P