Registration of Isobutanol as a Gasoline Additive: Opportunity for Public Comment |
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Byron J. Bunker
Environmental Protection Agency
29 March 2018
[Federal Register Volume 83, Number 61 (Thursday, March 29, 2018)]
[Proposed Rules]
[Pages 13460-13463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06119]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 79
[EPA-HQ-OAR-2018-0131; FRL-9975-89-OAR]
Registration of Isobutanol as a Gasoline Additive: Opportunity
for Public Comment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Request for information.
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SUMMARY: The Environmental Protection Agency (``EPA'' or ``the
Agency'') is seeking public comment on any aspect of the use of
isobutanol in gasoline. Butamax Advanced Biofuels, LLC (``Butamax''), a
manufacturer of isobutanol, has submitted an application pursuant to
the regulations titled ``Registration of Fuels and Fuel Additives'' for
the registration of isobutanol as a gasoline additive at up to 16
volume percent. Butamax has submitted information that would likely
satisfy the applicable registration requirements. The Clean Air Act
requires the EPA to register a fuel or fuel additive once all the
applicable registration requirements have been met by the manufacturer.
Due to the potential for the widespread introduction of isobutanol into
commerce, we are taking steps to make the public aware of the
likelihood of this registration. We are seeking public comment
regarding any issues we should take into consideration for this
registration and any supplemental actions we should consider under the
Clean Air Act to further protect public health and welfare.
DATES: Comments must be received on or before April 30, 2018.
ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2018-0131, to the Federal eRulemaking Portal: https://www.regulations.gov. Follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or withdrawn. The
EPA may publish any comment received to its public docket. Do not
submit electronically any information you consider to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Multimedia submissions (audio, video, etc.) must
be accompanied by a written comment. The written comment is considered
the official comment and should include discussion of all points you
wish to make. The EPA will in general not consider comments or comment
contents located outside of the primary submission (i.e. on the web,
cloud, or other file sharing system). For additional submission
methods, the full EPA public comment policy, information about CBI or
multimedia submissions, and general guidance on making effective
comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.
FOR FURTHER INFORMATION CONTACT: James W. Caldwell, Environmental
Engineer, Compliance Division, Office of Transportation and Air
Quality, Mail Code 6405A, U.S. Environmental Protection Agency, 1200
Pennsylvania Avenue NW, Washington, DC 20460; Telephone: (202) 343-
9303; Fax: (202) 343-2802; Email address: caldwell.jim@epa.gov.
SUPPLEMENTARY INFORMATION: The EPA is seeking public comment on any
aspect of the use of isobutanol in gasoline. Butamax Advanced Biofuels,
LLC (``Butamax''), a manufacturer of isobutanol, has submitted an
application pursuant to the regulations at 40 CFR part 79, Registration
of Fuels and Fuel Additives, for the registration of isobutanol, an
alcohol, as a gasoline additive at up to 16 volume percent. Our review
of the information Butamax has submitted leads us to believe that
Butamax would likely satisfy the applicable registration requirements
under 40 CFR part 79 (discussed in more detail below). Section 211(b)
of the Clean Air Act (Clean Air Act, CAA or the Act) requires the EPA
to register a fuel or fuel additive once all the applicable
registration requirements have been met by the manufacturer. While the
EPA does not have any specific concerns, due to the potential for the
widespread introduction of isobutanol into commerce, we are taking
steps to make the public aware of the likelihood of this registration
and are seeking public comment regarding any issues we should take into
consideration for this registration and/or any potential supplemental
actions we should consider under the Clean Air Act to further protect
public health and welfare.
I. Statutory and Regulatory Background
Section 211(a) and (b)--Fuels and Fuel Additives Designation and
Registration
Section 211(a) of the Act authorizes the Administrator to designate
fuels and fuel additives (F/FAs) by regulations and, once designated,
to register such F/FAs prior to introduction into commerce. To date,
the Administrator has designated on-highway motor vehicle gasoline and
gasoline additives and on-highway motor vehicle diesel and diesel
additives for registration. The EPA codified the registration
requirements under Sections 211(b) and 211(e) of the Act at 40 CFR part
79. Registration requirements at 40 CFR part 79 include emissions
speciation testing and a literature search of the associated emissions
(Tier 1 testing) and animal testing of exposure to emissions for
purposes of determining health effects (Tier 2 testing). Manufacturers
with less than $50 million in total annual sales are considered small
businesses, as specified in the regulations at 40 CFR 79.58(d). In
certain cases, a small
[[Page 13461]]
business is exempt from some or all of these testing requirements. For
any potential registrant with $50 million or more in total annual
sales, Tier 1 and Tier 2 requirements must be met before registration.
In addition, Sec. Sec. 79.11(i) and 79.21(h) respectively require
that fuel and fuel additive manufacturers demonstrate that their fuels
and fuel additives are substantially similar to those used in emissions
certification or have a waiver as part of 40 CFR part 79 registration.
The Tier 1 registration regulations at 40 CFR 79.52 require a
characterization of the emission products that are generated by
evaporation and combustion of a gasoline with, if applicable, an
oxygenated additive such as isobutanol. Combustion testing must be
conducted with and without after-treatment of exhaust emissions. A
literature search for information on the potential toxicological
environmental, and other public welfare effects is required for
emission products, except that it is not required for those emission
products that are the same as the emission products for baseline
gasoline (represented in testing by a gasoline with no oxygenates such
as ethanol or isobutanol). This is because a test group organized by
the American Petroleum Institute (API) has tested baseline gasoline and
also conducted the literature search for its emission products. The
results of this testing and literature search were reported in the 1997
API baseline gasoline Tier 1 literature review.
The regulations at 40 CFR 79.53 specify the requisite health
effects testing for compliance with Tier 2 as well as provisions for a
manufacturer that opts to rely on existing health effects test data to
satisfy these testing requirements. Additionally, the flexibility to
modify Tier 2 requirements and to require Alternative Tier 2 testing
can be found at 40 CFR 79.58(c). In 1998, EPA opted to modify the
standard Tier 2 testing requirements for gasoline and various
oxygenated gasoline blends and issued Alternative Tier 2 testing
requirements to the API ``Section 211(b) Research Group.'' This was
based on the EPA's determination that alternative test procedures would
yield more useful data than standard Tier 2 testing. The primary
difference between the testing for baseline gasoline and various
oxygenated gasoline blends, under the Alternative Tier 2 and standard
Tier 2 testing requirements, was that the Alternative Tier 2 testing
focused on identifying and evaluating potential adverse health effects
of evaporative emissions. It did not include examination of combustion
emissions. At the time, the EPA explained the rationale for focusing on
evaporative emissions and why the combustion emission studies would
likely not produce meaningful information as being due to
methodological complications caused by carbon monoxide (i.e., the
carbon monoxide component of the combustion exhaust emissions may be
lethal or otherwise compromise the health of the test animals). The EPA
required specific testing for baseline gasoline and various oxygenated
gasoline blends and these health studies have now been largely
completed and approved.
The regulations at 40 CFR 79.54 provide for additional testing
under Tier 3 provisions if the Tier 1 and Alternative Tier 2 data or
other data obtained by the Agency indicates that such testing is
warranted. The EPA has yet to initiate a Tier 3 process for any fuel or
fuel additive. If the EPA were to require Tier 3 testing, we would
develop the testing protocol and requirements through a public process.
CAA Section 211(f)--Substantially Similar and Waivers
Section 211(f)(1) of the Act makes it unlawful for any manufacturer
of any fuel or fuel additive to first introduce into commerce, or to
increase the concentration in use of, any fuel or fuel additive for use
by any person in motor vehicles manufactured after model year 1974
which is not substantially similar to any fuel or fuel additive
utilized in the certification of any model year 1975, or subsequent
model year, vehicle or engine under Section 206 of the Act. The EPA
last issued an interpretive rule on the phrase ``substantially
similar'' at 73 FR 22281 (April 25, 2008). Generally speaking, this
interpretive rule describes the types of unleaded gasoline that are
considered ``substantially similar'' to the unleaded gasoline utilized
in the EPA's emissions certification program by placing limits on a
gasoline's chemical composition and its physical properties, including
the amount of alcohols and ethers (oxygenates) that may be added to
gasoline. Gasoline and diesel fuels that are found to be
``substantially similar'' to the EPA's certification fuels may be
registered and introduced into commerce. The current ``substantially
similar'' interpretive rule for unleaded gasoline allows oxygen content
up to 2.7 percent oxygen by weight for certain ethers and alcohols,
which equates to approximately 12 volume percent isobutanol.\1\
Gasoline-isobutanol blends containing up to 16 volume percent
isobutanol would contain up to 3.7 percent oxygen by weight, which
exceeds the allowable limit for oxygen content under the current
``substantially similar'' interpretive rule, and would require a waiver
under section 211(f)(4) of the Act.
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\1\ See 56 FR 5352 (February 11, 1991).
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Section 211(f)(4) of the Act provides that upon application of any
fuel or fuel additive manufacturer, the Administrator may waive the
prohibitions of CAA section 211(f)(1) if the Administrator determines
that the applicant has established that such fuel or fuel additive, or
a specified concentration thereof, will not cause or contribute to a
failure of any emission control device or system (over the useful life
of the motor vehicle, motor vehicle engine, nonroad engine or nonroad
vehicle in which such device or system is used) to achieve compliance
by the vehicle or engine with the emission standards to which it has
been certified pursuant to Sections 206 and 213(a) of the Act. In other
words, the Administrator may grant a waiver for a prohibited fuel or
fuel additive if the applicant can demonstrate that the new fuel or
fuel additive will not cause or contribute to engines, vehicles or
equipment failing to meet their emissions standards over their useful
lives. The statute requires that the Administrator shall take final
action to grant or deny the application, after public notice and
comment, within 270 days of receipt of the application.
In addition, the regulations at Sec. Sec. 79.11(i) and 79.21(h)
require that fuel and fuel additive manufacturers must demonstrate that
their fuels and fuel additives, respectively, are substantially similar
or have a waiver as described in section 211(f) of the Act.
CAA Section 211(c)--Rulemaking To Regulate Fuels
Section 211(c)(1) of the Act allows the Administrator, by
regulation, to ``control or prohibit the manufacture, introduction into
commerce, offering for sale, or sale of any fuel or fuel additive for
use in a motor vehicle, motor vehicle engine, or nonroad engine or
nonroad vehicle (A) if, in the judgment of the Administrator, any fuel
or fuel additive or any emission product of such fuel or fuel additive
causes, or contributes, to air pollution or water pollution (including
any degradation in the quality of groundwater) that may reasonably be
anticipated to endanger the public health or welfare, or (B) if
emission products of such fuel or fuel additive will impair to a
significant degree the performance of any emission control device or
system which is in general use, or which the Administrator
[[Page 13462]]
finds has been developed to a point where in a reasonable time it would
be in general use were such regulation to be promulgated.'' Prior to
doing so, the EPA must consider scientific and medical evidence as well
as the costs of any control and setting regulations under Section 202
of the Act. The EPA must also publish a finding that a control or
prohibition will not result in the use of other substitute fuels or
fuel additives that will also endanger public health or welfare.
II. Registration of Isobutanol
Isobutanol Background
Isobutanol is a flammable colorless liquid that is used as a
gasoline additive and as an industrial solvent. Isobutanol is composed
of the chemical elements hydrogen, oxygen, and carbon and it can be
made from petroleum or renewable biomass, such as corn, grasses,
agricultural waste and other renewable sources. It can be used in
internal combustion engines as an additive to gasoline and is
registered under the 40 CFR part 79 as a gasoline additive for
manufacturers that are exempt from the Tier 1 and Alternative Tier 2
testing. A blend level of 16 percent for a non-exempt manufacturer
would require a new registration that would include meeting Tier 1 and
Alternative Tier 2 health effects testing requirements and a waiver
under CAA section 211(f)(4). Biobutanol is the common name for
isobutanol made from renewable sources.
There has been an increased interest in the use of biobutanol as a
direct result of the requirements for increased use of renewable fuel
volumes, adopted in the Energy Information and Security Act of 2007.
These provisions require an increase in the use of renewable fuels,
with 36 billion gallons of renewable fuel to be used in the U.S. by
2022. Parties required to meet these standards are interested in cost
effective and practical ways to satisfy the standards and meet the
performance needs of the vehicles and engines. Biobutanol is one
potentially attractive option because of its higher energy density,
lower blending vapor pressure, and lower heat of vaporization in
comparison to other alcohols such as ethanol.
Current Isobutanol Registrations
As previously discussed, regulations at 40 CFR 79.58(d) specify
that a company with total annual sales of less than $50 million is a
small business and is exempt in certain instances from applicable
testing requirements. The EPA has registered isobutanol as a fuel
additive for companies that qualified under this provision.
Fuel and fuel additive manufacturers with total annual sales of $50
million or greater do not qualify as small businesses, are prohibited
from registering the use of isobutanol produced by small businesses,
and instead must comply with all applicable registration requirements,
including health effects testing. Gasoline manufacturers typically have
sales greater than $50 million per year and would need to register
isobutanol as an additive to their gasoline if they wanted to use it.
Therefore, a gasoline manufacturer cannot rely on the registration of a
small additive manufacturer as a means of complying with the 40 CFR
part 79 registration requirements. Additionally, because no gasoline
manufacturer has completed the 40 CFR part 79 registration
requirements, including required health effects testing for isobutanol,
the agency has yet to grant a registration request of isobutanol as an
additive to gasoline by a gasoline manufacturer. This has resulted in
limiting isobutanol to blending at terminals by parties that are not
gasoline manufacturers. See the definition of fuel manufacturer at 40
CFR 79.2(d). For this reason, among others, isobutanol has yet to be
introduced into commerce in any significant volume.
Butamax--Isobutanol Registration
Butamax Advanced Biofuels, LLC (Butamax) has applied for
registration of the use of up to 16 percent by volume isobutanol as a
fuel additive in motor-vehicle gasoline.\2\ As discussed above, fuels
and fuel additives to motor-vehicle gasoline are required to be
registered by the EPA under 40 CFR part 79 prior to introduction into
commerce. As previously described, there are two main requirements for
the fuel or fuel additive manufacturer. First, the fuel or fuel
additive must be substantially similar to fuel additives used in
emissions certification, or, if not, have a waiver under CAA section
211(f)(4) (42 U.S.C. 7545(f)(4), 40 CFR 79.21(h)). A fuel containing a
blend of gasoline and 16 percent isobutanol is not substantially
similar to any EPA certification fuels so Butamax must operate via a
waiver under CAA section 211(f)(4) prior to registration. The EPA
allows manufacturers to use previously granted waivers if they can
satisfy the waiver's terms and conditions. Of relevance here is the
OCTAMIX waiver, which the EPA granted on February 8, 1988,\3\ and has
since modified the waiver on October 28, 1988,\4\ June 7, 2012,\5\ and
June 14, 2012.\6\ The waiver allows a variety of alcohols in gasoline,
including isobutanol, at up to 3.7 percent oxygen by weight. For a
gasoline with a typical density, this equates to a maximum of 16
percent isobutanol by volume when no other oxygenates are present.
Butamax has stated that it intends to produce the isobutanol fuel
additive for use in accordance with the OCTAMIX waiver. Butamax must
show that it will comply with all seven conditions in the OCTAMIX
waiver to be able to rely on that waiver to satisfy the registration
requirement at 40 CFR 79.21(h). The Agency has evaluated Butamax's
March 25, 2011 submission regarding Butamax\TM\ Advanced Biofuels LLC
and its application of the OCTAMIX Waiver for up to 16 volume percent
isobutanol as a fuel additive if blended with gasoline and agrees with
its evaluation that Butamax can meet all seven conditions specified in
the OCTAMIX waiver.
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\2\ Ethanol is allowed in gasoline at up to 15 percent by volume
for certain vehicles. Isobutanol at 16 percent by volume would not
have a vehicle restriction.
\3\ See 53 FR 3636 (February 8, 1988).
\4\ See 53 FR 43768 (October 28, 1988).
\5\ See 77 FR 33733 (June 7, 2012).
\6\ See 77 FR 35677 (June 14, 2012).
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Second, a manufacturer must conduct Tier 1 and either Tier 2 or
Alternative Tier 2 health-effects testing, unless the manufacturer is
exempt under the small-business provisions specified at 40 CFR
79.58(d). Butamax does not qualify as a small business and is not
exempt from these testing requirements. Additionally, the regulations
at 40 CFR 79.53(b) allow a manufacturer to rely on existing health
effects test data that would provide ``reasonably comparable''
information in lieu of conducting health effects testing ``regarding
the carcinogenicity, mutagenicity, neurotoxicity, teratogenicity,
reproductive/fertility measures, and general toxicity effects of the
emissions for a fuel or additive'' for registration. The Agency's
current review leads it to believe that Butamax will likely meet the
requisite health effects testing requirements for isobutanol at 16
percent through its submittal of information on testing for the health
effects end points identified under Alternative Tier 2 testing
procedures for oxygenates.\7\ Similarly, the Agency also believes that
Butamax will likely meet the other requirements for registration on EPA
Form 3520-13,
[[Page 13463]]
Fuel Additive Manufacturer Notification.
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\7\ Letter to Dr. Carol Henry, American Petroleum Institute,
from Margo Oge, U.S. EPA, November 2, 1998.
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III. Recent Studies Regarding Isobutanol Blended Gasolines
The OCTAMIX waiver evaluated a number of 1980s gasoline-fueled
vehicles on the effects of gasoline-alcohol mixtures (applicable to
isobutanol at up to 16 percent by volume) on those vehicles emissions
controls. Since then, studies have been conducted to evaluate the
potential effects of isobutanol on gasoline-fueled vehicles, engines,
and fuel dispensing and storage equipment. Recent testing on the use of
gasoline-isobutanol blended fuels illustrates that isobutanol-blended
fuels generally do not significantly affect oxides of nitrogen
(NOX), carbon monoxide (CO), or non-methane organic gas
(NMOG) emissions. In a recent study, gasoline was splash blended with
alcohols to produce four blends with a target value of 5.5 percent
oxygen by weight including a gasoline-isobutanol blend of 21 volume
percent isobutanol.\8\ The study found that the gasoline-isobutanol
blended fuel did not significantly affect NOX, CO, or NMOG
emissions.
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\8\ Ratcliff, M. A.; Luecke, J.; Williams, A.; Christensen, E.;
Yanowitz, J.; Reek, A.; and McCormick, R. L.; Impact of higher
alcohols blended in gasoline on light-duty vehicle exhaust
emissions. Environ. Sci. Technol., 2013, 47 (23), pp 13865-13872.
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In a test of isobutanol exposure impacts on fueling infrastructure
materials, the observed swell for elastomers for exposures to 16
percent and 24 percent gasoline blends were similar to but slightly
less than the oxygen equivalent ethanol fuels of E10 and E17. Samples
of metals commonly found in fuel storage and dispensing systems were
immersed in 16 percent and 24 percent isobutanol blends at 60 [deg]C
for 28 days. In all cases, the annualized corrosion rates for
isobutanol based on weight loss were negligible.\9\
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\9\ Kass, M.; Theiss, T.; Janke, C.; Pawel, S.; et al;
Compatibility study for plastic, elastomeric, and metallic fueling
infrastructure materials exposed to aggressive formulations of
isobutanol-blended gasoline. Oak Ridge National Laboratory, 2014.
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Finally, in a 50-hour field emissions test of 175 horsepower and
215 horsepower boating engines, 16.1 volume percent isobutanol (blended
to 93 octane) showed similar total HC+NOX emissions compared
to a non-oxygenated certification gasoline.\10\ In that same test, CO
emissions were reduced using isobutanol vs. indolene which was expected
as isobutanol is a partially oxidized fuel. The enleanment reported for
16.1 percent isobutanol was in line with what is typical of E10
relative to indolene. The study noted that no operability issues were
observed while the marine engines were operated on the gasoline-
isobutanol blended fuels.\11\
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\10\ Until changed in the Tier 3 rulemaking (see 79 FR 23414,
April 28, 2014), certification gasoline did not contain ethanol, or
any other oxygenates. However, the Tier 3 rulemaking now requires
federal motor vehicle gasoline certification fuel to contain 10
volume percent ethanol.
\11\ Wasil, J. R.; McKnight, J.; Kolb, R.; Munz, D.; Adey, J.;
and Goodwin, B.; In-use performance testing of butanol-extended fuel
in recreational marine engines and vessels. SAE [Tech Pap.] 2012.
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The Agency believes that based on the referenced studies on the
potential effects of isobutanol on gasoline-fueled vehicles and engines
and its engineering judgement, that modern motor vehicles and engines
should continue to meet emissions standards and suffer no issues with
driveability or operability on gasoline-isobutanol blended fuels up to
16 volume percent. However, even though the information cited above
concerning regulated emissions, retail fuel dispensing and storage
equipment materials, and marine engines suggests that isobutanol
blended into gasoline should not pose any significant issues, the
narrowness of the size and scope of these studies does not address all
potential effects isobutanol may have on gasoline-fueled vehicles and
engines. Therefore, the Agency seeks comment on whether there is
available information on other areas that should be addressed for
gasoline-isobutanol blended fuels up to 16 volume percent. The Agency
could use information gleaned from this public comment process to
determine whether further controls might be necessary (potentially via
rulemaking under section 211(c) of the Act) to help ensure the smooth
introduction of isobutanol into the gasoline market or to help
determine whether the Agency should impose certain conditions on the
registration of isobutanol as a gasoline additive through 40 CFR part
79.
IV. Conclusion
The EPA will register isobutanol for Butamax in accordance with the
regulations at 40 CFR part 79 once applicable requirements are met.
Butamax has submitted the required information, including: (1) The
speciation of exhaust and evaporative emissions for gasoline with 16
percent isobutanol (Tier 1 testing), (2) a literature search for health
information on the Tier 1 emissions found for that blend that were not
found in the Tier 1 testing of gasoline without any oxygenate, and (3)
the results of the Alternative Tier 2 health-effects testing for that
blend (animal exposure to evaporative emissions). Butamax has also
submitted information to demonstrate that it can comply with the
requirements of the OCTAMIX waiver, which allows the blending of
isobutanol into gasoline at up to 3.7 percent oxygen by weight, or 16
percent isobutanol by volume.
The EPA seeks comments and any information and data on the use of
isobutanol in gasoline, including, but not limited to: (1) The need for
additional health-effects testing under the Tier 3 provisions in the
regulations, and (2) the need for additional regulatory controls for 16
percent isobutanol in gasoline, beyond those for gasoline at 40 CFR
parts 79 and 80, under the authority of CAA section 211(c).
Dated: March 15, 2018.
Byron J. Bunker,
Director, Compliance Division, Office of Transportation and Air
Quality, Office of Air and Radiation.
[FR Doc. 2018-06119 Filed 3-28-18; 8:45 am]
BILLING CODE 6560-50-P