[Federal Register Volume 82, Number 247 (Wednesday, December 27, 2017)]
[Proposed Rules]
[Pages 61205-61213]
[FR Doc No: 2017-27946]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 80

[EPA-HQ-OAR-2017-0655; FRL-9972-59-OAR]
RIN 2060-AT82

Proposed Rule; Renewable Fuel Standard Program; Grain Sorghum Oil
Pathway

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: In this proposed rule, the Environmental Protection Agency
(EPA) is providing an opportunity to comment on an analysis of the
lifecycle greenhouse gas (GHG) emissions associated with certain
biofuels that are produced from grain sorghum oil extracted at dry mill
ethanol plants at any point downstream from sorghum grinding, also
known as distiller sorghum oil. EPA seeks comment on its proposed
assessment that using distillers sorghum oil as feedstock results in no
significant agricultural sector GHG emissions; and that biodiesel and
heating oil produced from distillers sorghum oil via a
transesterification process, and renewable diesel, jet fuel, heating
oil, naphtha, and liquefied petroleum gas (LPG) produced from
distillers sorghum oil via a hydrotreating process, would meet the
lifecycle GHG emissions reduction threshold of 50 percent required for
advanced biofuels, and biomass-based diesel under the Renewable Fuel
Standard program. Based on these analyses, EPA is proposing to amend
the RFS program regulations to define the term ``distillers sorghum
oil''. We also propose to add to the regulations approved pathways from
the production of biodiesel and heating oil from distillers sorghum oil
via a transesterification process, and renewable diesel, jet fuel,
heating oil, naphtha, and liquefied petroleum gas (LPG) produced from
distillers sorghum oil via a hydrotreating process.

DATES: Comments must be received on or before January 26, 2018.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2017-0655, at http://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or withdrawn from Regulations.gov. 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 generally 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: Diana Galperin, Office of Air and
Radiation, Office of Transportation and Air Quality, Mail Code: 6401A,
U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

Outline of This Preamble

I. General Information
II. Public Participation
III. Introduction
IV. Analysis of GHG Emissions Associated With Production of Biofuels
From Distillers Sorghum Oil
    A. Overview of Distillers Sorghum Oil
    B. Analysis of Lifecycle GHG Emissions
    1. Livestock Sector Impacts
    2. Feedstock Production
    3. Feedstock Transport
    4. Feedstock Pretreatment
    5. Fuel Production
    6. Fuel Distribution
    7. Fuel Use
    8. Results of GHG Lifecycle Analysis
V. Consideration of Lifecycle Analysis Results
VI. Summary
VII. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs
    C. Paperwork Reduction Act
    D. Regulatory Flexibility Act (RFA)
    E. Unfunded Mandates Reform Act (UMRA)
    F. Executive Order 13132: Federalism
    G. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    H. Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
    I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
    J. National Technology Transfer Advancement Act (NTTAA)
    K. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations

I. General Information

A. Does this action apply to me?

    Entities potentially affected by this proposed rule are those
involved with the production, distribution, and sale of transportation
fuels, including gasoline and diesel fuel or renewable fuels such as
ethanol, biodiesel, heating oil, renewable diesel, naphtha and
liquefied petroleum gas. Potentially regulated categories include:

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 Examples of potentially affected
             entities                         NAICS \1\ codes
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Sorghum Farming..................  11119, 111191, 111199
Petroleum refineries (including    324110
 importers)..
Ethyl alcohol manufacturing......  325193
Other basic organic chemical       325199
 manufacturing..
Chemical and allied products       424690
 merchant wholesalers..
Petroleum Bulk Stations and        424710, 424720
 Terminals; Petroleum.
Other fuel dealers...............  454310
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    This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be regulated by this
action. This table lists the types of entities that the EPA is now
aware could potentially be affected by this action. Other types of
entities not listed in the table could also be affected. To determine
whether your entity is regulated by this action, you should carefully
examine the applicability criteria in the referenced regulations. If
you have any questions regarding the applicability of this action to a
particular entity, consult the person listed in the FOR FURTHER
INFORMATION CONTACT section.
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    \1\ North American Industry Classification System.
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B. What action is the Agency taking?

    EPA is proposing to amend the RFS program regulations to define the
term ``distillers sorghum oil'' as oil from grain sorghum that is
extracted at a dry mill ethanol plant at any location downstream of
grinding the grain sorghum kernel, provided that the grain sorghum is
converted to ethanol, the oil is rendered unfit for food uses without
further refining, and the distillers grains resulting from the dry mill
and oil extraction processes are marketable as animal feed. We also
propose to add to Table 1 to 80.1426(f), approved pathways from the
production of biodiesel and heating oil from distillers sorghum oil via
a transesterification process, and renewable diesel, jet fuel, heating
oil, naphtha, and liquefied petroleum gas (LPG) produced from
distillers sorghum oil via a hydrotreating process. Alternatively, or
in addition, EPA may consider the comments it receives in response to
this document in evaluating facility-specific pathway petitions
submitted pursuant to 40 CFR 80.1416 that propose using distillers
sorghum oil to make biofuel.

C. What is the Agency's authority for taking this action?

    Statutory authority for this action comes from Clean Air Act
sections 114, 208, 211, and 301.

II. Public Participation

    EPA will not hold a public hearing on this matter unless a request
is received by the person identified in the FOR FURTHER INFORMATION
CONTACT section of this preamble by January 11, 2018. If EPA receives
such a request, we will publish information related to the timing and
location of the hearing and a new deadline for public comment.

III. Introduction

    Section 211(o) of the Clean Air Act (CAA) establishes the Renewable
Fuel Standard (RFS) program, under which EPA sets annual percentage
standards specifying the amount of renewable fuel, as well as three
subcategories of renewable fuel, that must be used to reduce or replace
fossil fuel present in transportation fuel, heating oil, or jet

fuel. Non-exempt \2\ renewable fuels must achieve at least a 20 percent
reduction in lifecycle GHG emissions as compared to a 2005 petroleum
baseline. Advanced biofuel and biomass-based diesel must achieve at
least a 50 percent reduction, and cellulosic biofuel must achieve at
least a 60 percent reduction.
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    \2\ A baseline volume of renewable fuel produced from facilities
that commenced construction on or before December 19, 2007, and
which completed construction by December 19, 2010 without an 18-
month hiatus in construction, is exempt from the minimum 20 percent
GHG reduction requirement that otherwise applies to renewable fuel.
In addition, a baseline volume of ethanol from facilities that
commenced construction after December 19, 2007, and on or before
December 31, 2009, qualifies for the same exemption if construction
was completed within 36 months without an 18-month hiatus in
construction; the facility was fired with natural gas, biomass, or
any combination thereof, at all times the facility operated between
December 19, 2007 and December 31, 2009; and the baseline volume
continues to be produced through processes fired with natural gas,
biomass, or any combination thereof.
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    In addition to the lifecycle GHG reduction requirements, renewable
identification numbers (RINs) may only be generated if the fuel meets
the other definitional criteria for renewable fuel (e.g., produced from
renewable biomass as defined in the regulations, and used to reduce or
replace the quantity of fossil fuel present in transportation fuel,
heating oil, or jet fuel) in CAA section 211(o) and the RFS regulations
at 40 CFR part 80 subpart M.
    Since the formation of the RFS program, EPA has periodically
promulgated rules to add new pathways to the regulations.\3\ In
addition, EPA has approved facility-specific pathways through the
petition process in 40 CFR 80.1416. There are three critical components
of approved fuel pathways under the RFS program: (1) Fuel type; (2)
feedstock; and (3) production process. Each pathway is associated with
a specific ``D code'' depending on whether the fuel meets the
requirements for renewable fuel, advanced fuel, cellulosic fuel, or
biomass-based diesel.
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    \3\ Please see information on Pathways I and Pathways II in 40
CFR part 80 subpart M, and in the Federal Register at 78 FR 14190
(March 5, 2013) and 79 FR 42128 (July 18, 2014). More information on
these can be found at: https://www.epa.gov/renewable-fuel-standard-program/final-rule-identify-additional-fuel-pathways-under-renewable-fuel and https://www.epa.gov/renewable-fuel-standard-program/renewable-fuel-pathways-ii-final-rule-identify-additional-fuel.
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    EPA's lifecycle analyses are used to assess the overall GHG
emissions of a fuel throughout each stage of its production and use.
The results of these analyses, considering uncertainty and the weight
of available evidence, are used to determine whether a fuel meets the
necessary GHG reductions required under the CAA. Lifecycle analysis
includes an assessment of emissions related to the full fuel lifecycle,
including feedstock production, feedstock transportation, fuel
production, fuel transportation and distribution, and tailpipe
emissions. Per the CAA definition of lifecycle GHG emissions, EPA's
lifecycle analyses also include an assessment of significant indirect
emissions, such as those from land use changes and agricultural sector
impacts.
    EPA received a petition from the National Sorghum Producers (NSP),
submitted under partial claims of confidential business information
(CBI), requesting that EPA evaluate the GHG emissions associated with
biofuels produced using grain sorghum oil derived from dry mill ethanol
production as a feedstock, and that EPA provide a determination of the
renewable fuel categories, if any, for which such biofuels may be
eligible. In this action, EPA is proposing to amend the RFS program
regulations to define the term ``distillers sorghum oil'' as oil from
grain sorghum that is extracted at a dry mill ethanol plant at any
location downstream of grinding the grain sorghum kernel, provided that
the grain sorghum is converted to ethanol, the oil is rendered unfit
for food uses without further refining, and the distillers grains
resulting from the dry mill and oil extraction processes are marketable
as animal feed. We also propose to add to Table 1 to 40 CFR 80.1426(f),
approved pathways from the production of biodiesel and heating oil from
distillers sorghum oil via a transesterification process, and renewable
diesel, jet fuel, heating oil, naphtha, and LPG produced from
distillers sorghum oil via a hydrotreating process. Alternatively, or
in addition, EPA may consider the comments it receives in response to
this document in evaluating facility-specific pathway petitions
submitted pursuant to 40 CFR 80.1416 that propose using distillers
sorghum oil to make biofuel.
    This preamble describes EPA's analysis of the GHG emissions
associated with distillers sorghum oil when used to produce specified
biofuels. The analysis considers a scenario where distillers sorghum
oil is extracted from distillers grains with solubles (DGS) at dry mill
plants that produce ethanol from grain sorghum and where the remaining
reduced-oil DGS co-product is used as animal feed. The distillers
sorghum oil is then used as a feedstock for conversion into certain
biofuels. As described in Section IV of this preamble, we estimate that
the lifecycle GHG emissions associated with the production of biodiesel
and heating oil produced from distillers sorghum oil via a
transesterification process, and renewable diesel, jet fuel, naphtha,
and LPG, produced from distillers sorghum oil via a hydrotreating
process, are approximately 80 percent less than the lifecycle GHG
emissions associated with the baseline petroleum fuels they would
replace. Based on these results, we propose to find that these biofuels
would meet the 50 percent GHG reduction threshold required for advanced
biofuel and biomass-based diesel. We also anticipate that heating oil
produced through transesterification or hydrotreating from distillers
sorghum oil would meet the 50 percent GHG emission reduction threshold
required for advanced biofuel and biomass-based diesel.\4\ EPA is
seeking public comment on its analyses of the lifecycle GHG emissions
related to biofuels produced from distillers sorghum oil.
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    \4\ As defined in the RFS regulations at 40 CFR 80.1401,
biomass-based diesel excludes renewable fuel that is co-processed
with petroleum. Such fuel may qualify as advanced biofuel if it
meets the 50 percent GHG reduction threshold.
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IV. Analysis of GHG Emissions Associated With Production of Biofuels
From Distillers Sorghum Oil

A. Overview of Distillers Sorghum Oil

    Dry mill ethanol plants grind and ferment grain sorghum, produce
ethanol from the fermented grain sorghum starch, and also produce a DGS
co-product (made of non-fermentable solids, solubles syrup, and sorghum
oil) that is sold as a type of livestock feed. A portion of the oil
that would otherwise reside in the DGS can be extracted at the ethanol
plant, typically through gravimetric methods. At dry mill ethanol
plants, sorghum oil is recovered through methods nearly identical to
that of corn oil extracted from DGS, and corn and sorghum oil
extraction can occur at the same facilities.
    EPA has approved pathways for the production of ethanol from grain
sorghum made through a dry mill process as qualifying for renewable
fuel (D code 6) RINs, and in some cases advanced biofuel (D code 5)
RINs, depending on process energy sources used during production.\5\
However, the regulations do not currently include pathways for the
production of other biofuels from grain sorghum. According to the U.S.
Department of Agriculture (USDA), the largest regions for grain sorghum
production in the United States are located in Texas, Oklahoma, and
Kansas.\6\ Currently about 30 percent

of grain sorghum grown, or 120 million bushels a year, goes towards
ethanol production.\7\ For comparison, in recent years over 5,200
million bushels of corn have been used for ethanol production
annually.\8\ Distillers sorghum oil is still a relatively niche
product, and the NSP petition anticipates a potential of 12 to 21
million ethanol-equivalent gallons of fuel to be produced from the oil
per year.
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    \5\ Table 1 to 40 CFR 80.1426, Rows R and S.
    \6\ USDA, NASS, ``Sorghum for Grain 2016 Harvested Acres by
County for Selected States,'' https://www.nass.usda.gov/Charts_and_Maps/graphics/AS-HA-RGBChor.pdf.
    \7\ Sorghum Checkoff, ``Renewables,'' http://www.sorghumcheckoff.com/market-opportunities/renewables, accessed
09-05-2017.
    \8\ USDA, ERS, ``Table 5-- Corn supply, disappearance, and share
of total corn used for ethanol,'' U.S. Bioenergy Statistics, https://www.ers.usda.gov/data-products/us-bioenergy-statistics/us-bioenergy-statistics/#Feedstocks, accessed 09-05-2017.
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    We propose to define distillers sorghum oil to mean oil recovered
at a point downstream of where a dry mill grain sorghum ethanol plant
grinds the grain sorghum, provided that the grain sorghum is converted
to ethanol, the oil is rendered unfit for food uses without further
refining, and the distillers grains resulting from the dry mill and oil
extraction processes are marketable as animal feed. So long as these
criteria are met, a variety of recovery methods could be implemented.
For example, this would include recovery of sorghum oil before
fermentation from the slurry or from liquefaction tanks. It would also
include recovery of sorghum oil after fermentation from the thin
stillage and/or DGS. Further, it would also include recovery of sorghum
oil by a third-party from DGS produced by a dry mill sorghum ethanol
plant.

B. Analysis of Lifecycle GHG Emissions

    EPA evaluated the GHG emissions associated with using distillers
sorghum oil as a biofuel feedstock based on information provided by the
petitioner and other available data sources. GHG emissions include
emissions from production and transport of distillers sorghum oil; the
processing of the oil into biofuel; transport of the biofuel from the
production facility to the fuel-blender; and, ultimately the use of the
biofuel by the end consumer. The methodology EPA used for this analysis
is generally the same approach used for the March 2010 RFS rule for
lifecycle analyses of several other biofuel feedstocks, such as
distillers corn oil and yellow grease.\9\ We believe that applying the
same methodology for these feedstocks is appropriate given similarities
in how these feedstocks are produced, transported and processed into
biofuel. These similarities are explained further in this section.
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    \9\ The March 2010 RFS rule preamble (75 FR 14670, March 26,
2010) and Regulatory Impact Analysis (RIA) (EPA-420-R-10-006)
provide further discussion of our approach. These documents are
available online at https://www.epa.gov/renewable-fuel-standard-program/renewable-fuel-standard-rfs2-final-rule-additional-resources.
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    EPA's lifecycle analyses include upstream emissions, which include
the significant direct and indirect GHG emissions (including such
emissions from land use changes) associated with producing a feedstock
and transporting it to the processing facility. All of the upstream
emissions were calculated and taken into account in EPA's evaluation of
the lifecycle GHG emissions associated with grain sorghum ethanol.\10\
Based on our analysis, producing distillers sorghum oil at a dry mill
ethanol plant converting grain sorghum to ethanol, and using the
extracted sorghum oil as a biofuel feedstock does not result in
additional upstream emissions, compared to the upstream emissions that
have already been calculated and attributed to grain sorghum ethanol.
Further, based on our analysis, the production of distillers sorghum
oil does not significantly impact the upstream emissions associated
with grain sorghum ethanol. While producing distillers sorghum oil may
impact livestock markets, through the effects of de-oiling DGS, we
discuss in the next section why, based on the data we have reviewed, we
do not anticipate this to cause any significant indirect impacts. We
welcome comments on this data and analysis.
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    \10\ See the December 2012 grain sorghum ethanol rule (77 FR
74592).
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1. Livestock Sector Impacts
    During a typical dry mill ethanol production process, DGS are
produced. These DGS are then used as animal feed, thereby displacing
feed crops and the GHG emissions associated with growing and
transporting those feed crops. When distillers sorghum oil is produced,
DGS continue to be created with reduced oil content. A significant
portion of this analysis focuses on reviewing how reduced-oil DGS
compare to full-oil DGS in terms of feed values and displacement of
other feeds.
    Chemically, full-oil and reduced-oil sorghum DGS share similar
compositions, primarily made up of crude protein, fat, and natural and
acid detergent fibers. Where the two products differ most significantly
is in their acid detergent fiber and fat concentrations. Table IV.1
shows the key nutrients that make up dried full-oil and reduced-oil
DGS.
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    \11\ The chart lists the most prominent nutrients in distillers
grains. Data provided by the National Sorghum Producers. Data for
full-oil Sorghum DDGS is sourced from Nutrient Requirements of
Swine, 2012 National Academies Press, Washington DC, pg 329. Data
for reduced-oil Sorghum DDGS was calculated by National Sorghum
Producers using the ratio of (1) corn DDGS, between 6 to 9 percent
Oil; and (2) corn DDGS, less than 4 percent oil from Nutrient
Requirements of Swine, 2012 National Academies Press, Washington,
DC, pp. 266 and 267.

   Table IV.1--Key Nutrient Make-Up of Full-Oil and Reduced-Oil Dried
               Distillers Grains With Solubles (DDGS) \11\
------------------------------------------------------------------------
                                                                Reduced-
                                                     Full-oil     oil
                     Nutrient                        sorghum    sorghum
                                                       DDGS       DDGS
------------------------------------------------------------------------
Crude Protein, %..................................      30.80      31.36
Crude Fat, % (aka Ether Extract)..................       9.75       3.91
Neutral Detergent Fiber (NDF), %..................      33.60      37.23
Acid Detergent Fiber (ADF), %.....................      22.68      31.91
Ash, %............................................       6.62       7.60
Calcium, %........................................       0.12       0.08
Phosphorus, %.....................................       0.76       0.96
Lysine, %.........................................       0.82       0.62
Methionine, %.....................................       0.54       0.47
Cystine, %........................................       0.53       0.61
Tryptophan, %.....................................       0.25       0.23
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    The difference in fat values is important as crude fat
concentrations impact net energy uptake by the livestock. A memorandum
to the docket shows the total net energy profiles by livestock of full-
oil and reduced-oil sorghum DGS.\12\ Should fat content not be at
sufficient levels, livestock producers might need to add nutrients or
other types of feed to meet appropriate nutritional targets. This is
reflected in the ``displacement rate'' of a DGS, which indicates how
much weight a pound of distillers grain can replace of another feed. A
lower displacement rate for a reduced-oil distillers grain as compared
to a full-oil distillers grain could result in additional GHG emissions
as it suggests that additional feed is required. In the case of
reduced-oil sorghum DGS, we believe that it is unlikely that additional
feed will be needed to backfill for the extracted oil.
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    \12\ ``Summary of Net Energy Impacts of Reduced-Oil Sorghum
Dried Distillers Grains with Solubles (DDGS) on Livestock,'' Air
Docket EPA-HQ-OAR-2017-0655.
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    Research suggests that for poultry and swine, ``increased
concentrations of free fatty acids have a negative impact on

lipid digestion and energy content.'' \13\ Free fatty acids are a class
of acids that form part of a lipid molecule. Full-oil DGS typically
contain higher levels of free fatty acids and thus may have a negative
impact on the fat digestion of poultry and swine. This supports the
conclusion that while the fat content may be lower for reduced-oil DGS,
feeding values of this product should not be worse than full-oil DGS
for poultry and swine.
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    \13\ Kerr, B.J., W.A. Dozier, and G.C. Shurson. (2016). ``Lipid
digestibility and energy content of distillers' corn oil in swine
and poultry,'' Journal of Animal Science. 94:2900-2908. doi:10.2527/
jas.2016-0440, pp. 2905.
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    For dairy, there are also benefits from feeding reduced-oil DGS as
compared to full-oil DGS. Research on dairy cows shows that reduced-oil
DGS produce a lessened likelihood of the onset of milk fat
depression.\14\ Milk fat depression occurs when milk fat is reduced by
0.2 percent or more.\15\ If milk fat depression occurs over the long
term, a decline in overall milk production may occur as well as
worsened health conditions of the herd. High fat diets have been linked
with this condition and have been shown to worsen the rumen environment
of dairy cattle.\16\ Therefore, dairy producers seek to avoid high fat
diets. Given the benefits of reduced-oil DGS over full-oil DGS for milk
fat production, it is expected that reduced-oil DGS will be preferred
over full-oil DGS by dairy producers and that displacement rates will
be no worse than those of full-oil DGS.
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    \14\ H.A. Ramirez-Ramirez, E. Castillo Lopez, C.J.R. Jenkins,
N.D. Aluthge, C. Anderson, S.C. Fernando, K.J. Harvatine, P.J.
Kononoff, (2016). ``Reduced-fat dried distillers grains with
solubles reduces the risk for milk fat depression and supports milk
production and ruminal fermentation in dairy cows,'' Journal of
Dairy Science, Volume 99, Issue 3 Pages 1912-1928, ISSN 0022-0302,
http://dx.doi.org/10.3168/jds.2015-9712. (http://www.sciencedirect.com/science/article/pii/S0022030216000515)
    \15\ University of Kentucky, ``Preventing Milk Fat Depression in
Dairy Cows,'' https://afs.ca.uky.edu/dairy/preventing-milk-fat-depression-dairy-cows. Accessed September 8, 2018. On the herd level
milk fats range from 3 to 5 percent normally. Oetzel, Garret R.,
``Subacute Ruminal Acidosis in Dairy Herds: Physiology,
Pathophysiology, Milk Fat Responses, and Nutritional Management.''
Preconference Seminar 7A: Dairy Herd Problem Investigation
Strategies: Lameness, Cow Comfort, and Ruminal Acidosis, American
Association of Bovine Practitioners, 40th Annual Conference,
September 17, 2007--Vancouver, BC, Canada, https://www.vetmed.wisc.edu/dms/fapm/fapmtools/2nutr/sara1aabp.pdf pp.98.
    \16\ PennState Extension, ``Troubleshooting Problems with
Milkfat Depression,'' August 14, 2017, https://extension.psu.edu/troubleshooting-problems-with-milkfat-depression. Accessed September
8, 2017.
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    An impact on displacement rates may occur when reduced-oil instead
of full-oil DGS are used for beef cattle, which has the ability to
digest additional fat. Table IV.2 shows the displacement ratios for the
livestock sectors where dried DGS (DDGS) are used. In this table, for
instance, 1 pound of reduced-oil DDGS fed to beef cattle displaces
1.173 pounds of corn. A pound of full-oil and reduced-oil DDGS also
displace equal portions (0.056 pounds) of urea. Urea is a non-protein
nitrogen compound that is typically fed to cattle for aiding the
production of protein by rumen microbes.\17\ These values show that for
dairy, swine, and poultry, reduced-oil DDGS replace the same amounts of
alternative feed despite containing less oil.
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    \17\ PennState Extension, ``Urea in Beef Cattle Rations,''
August 8, 2017, https://extension.psu.edu/urea-in-beef-cattle-rations. Accessed October 18, 2017.

                          Table IV.2--Full-Oil and Reduced-Oil Sorghum Distillers Grains With Solubles Displacement Ratios \18\
                                   [lb of ingredient/lb of sorghum distillers grains with solubles, dry matter basis]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                  Beef cattle                Dairy cattle                    Swine                   Poultry \19\
               Ingredient                ---------------------------------------------------------------------------------------------------------------
                                            Full-Oil     Reduced-Oil    Full-Oil     Reduced-Oil    Full-Oil     Reduced-Oil    Full-Oil     Reduced-Oil
--------------------------------------------------------------------------------------------------------------------------------------------------------
Corn....................................         1.196         1.173         0.731         0.731         0.890         0.890         0.292         0.292
Soybean Meal............................  ............  ............         0.633         0.633         0.095         0.095
Urea....................................         0.056         0.056
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    We anticipate that sorghum oil producers will seek to sell reduced-
oil DGS to poultry, swine, and dairy cow producers, as these markets
allow them to obtain a higher value for their product. Dairy cattle
producers may be willing to pay a premium for reduced-oil distillers
grains, as data suggests lower oil DGs improve milk production. Sales
of reduced-oil DGS to the beef cattle market are less likely, and in
these cases we anticipate that should a higher fat product be required,
the fat content of the DGS could be augmented through the addition of
distillers sorghum oil, thereby reducing the volumes of biofuel
produced from distillers sorghum oil but not causing additional
indirect GHG emissions. Therefore, we do not expect that sorghum oil
extraction will have a significant impact on the feed value of DGS and
thus will have no significant indirect GHG impacts per pound of DGS. We
welcome comment on this assessment.
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    \18\ Information provided by National Sorghum Producers, using
the following sources Arora et al., (2008). Argonne National
Laboratory. ``Update of distillers grains displacement ratios for
corn ethanol life-cycle analysis''; Kerr et al., (2016). ``Lipid
digestibility and energy content of distillers' corn oil in swine
and poultry,'' Journal of Animal Science 94:2900-8.; Opheim et al.,
(2016). ``Biofuel feedstock and blended coproducts compared with
deoiled corn distillers grains in feedlot diets: Effects on cattle
growth performance, apparent total tract nutrient digestibility, and
carcass characteristics,'' Journal of Animal Science 94:227.;
Ramirez et al., (2016). ``Reduced-fat dried distillers grains with
solubles reduces the risk for milk fat depression and supports milk
production and ruminal fermentation in dairy cows,'' Journal of
Dairy Science 99:1912-28. Poultry displacement ratios were provided
by the National Sorghum Producers and calculated based on data from
the Iowa State Extension Services, Agricultural Marketing and
Resources Center, ``Estimated U.S. Dried Distillers Grains with
Solubles (DDGS) Production and Use, https://www.extension.iastate.edu/agdm/crops/outlook/dgsbalancesheet.pdf.
    \19\ Protein sources such as soybean meal can be used to
supplement sorghum DGS for poultry.
---------------------------------------------------------------------------

2. Feedstock Production
    Distillers sorghum oil is removed from DGS at dry mill ethanol
plants using the same equipment and technologies used for corn oil
extraction. Oil extraction requires thermal energy to heat the DGS and
electricity to power centrifuges, pumps and other oil recovery
equipment. Our analysis for the March 2010 RFS final rule,\20\ the NSP
petition, and two studies,21 22 indicate that although
extracting oil from DGS uses thermal

energy, it also leads to relatively less thermal energy being used
later in the process to dry the DGS, resulting in an overall negligible
change in thermal energy requirements for plants that dry their DGS.
Our analysis here includes both the thermal and electrical energy
requirements to remove the distillers sorghum oil. We do not account
for the reduction in thermal energy needed for DGS drying mentioned
above, so this can be viewed as a conservative approach (i.e.,
resulting in higher estimated GHG emissions) for plants that dry their
DGS.\23\ Based on data reviewed by EPA,\24\ we assume 200 Btu (British
thermal units) of grid electricity and 800 Btu of natural gas are used
to extract distillers sorghum oil from DGS, per pound of distillers
sorghum oil extracted. These parameters are based on energy
requirements associated with extracting oil from DGS at dry mill
ethanol plants, but we believe they are also appropriate and
conservative in cases where the oil is extracted at any point
downstream from sorghum grinding.
---------------------------------------------------------------------------

    \20\ See section <IP_ADDRESS> of USEPA (2010). Renewable fuel
standard program (RFS2) regulatory impact analysis. U.S.
Environmental Protection Agency Office of Transportation Air
Quality, EPA-420-R-10-006. Washington, DC. https://www.epa.gov/sites/production/files/2015-08/documents/420r10006.pdf.
    \21\ Wang, Z., et al. (2015). ``Influence of corn oil recovery
on life-cycle greenhouse gas emissions of corn ethanol and corn oil
biodiesel.'' Biotechnology for Biofuels 8(1): 178.
    \22\ Mueller, S., Kwik, J. (2013). ``2012 Corn Ethanol: Emerging
Plant Energy and Environmental Technologies.''
    \23\ The purpose of lifecycle assessment under the RFS program
is not to precisely estimate lifecycle GHG emissions associated with
particular biofuels, but instead to determine whether or not the
fuels satisfy specified lifecycle GHG emissions thresholds to
qualify as one or more of the four types of renewable fuel specified
in the statute. Where there are a range of possible outcomes and the
fuel satisfies the GHG reduction requirements when ``conservative''
assumptions are used, then a more precise quantification of the
matter is not required for purposes of a pathway determination.
    \24\ See sources referenced in footnotes 20 and 21 for energy
use associated with oil extraction, and California Air Resources
Board (2014). ``California-Modified GREET Fuel Pathway: Biodiesel
Produced in the Midwestern and the Western U.S. from Corn Oil
Extracted at Dry Mill Ethanol Plants that Produce Wet Distiller's
Grains with Solubles.'' Staff Summary, Method 1 Fuel Pathway.
---------------------------------------------------------------------------

    As discussed above, we do not expect sorghum oil extraction to
significantly change the feed value of DGS on a per pound basis.
According to the NSP petition, grain sorghum oil yields should be 0.67
pounds per bushel of grain sorghum feedstock.\25\ EPA's modeling for
the December 2012 grain sorghum ethanol final rule (77 FR 74592)
assumed average dried DGS yield of 17 pounds per bushel of grain
sorghum feedstock. Thus, sorghum oil extraction may reduce the total
mass of DGS produced by up to approximately 4 percent. If full-oil and
reduced-oil DGS have equivalent feed value on a per pound basis, we
would expect a reduction in the total mass of DGS produced to impact
livestock feed markets and result in a net increase in GHG emissions if
production of other feed crops (e.g., corn, soybeans) increased to
backfill the lost DGS, given that producing additional corn and
soybeans would result in more GHG emissions.\26\ However, if reduced-
oil DGS are more beneficial than full oil DGS for dairy cows, on a per
pound of DGS basis, that could offset some or all of the impacts
associated with the DGS mass reduction. The information currently
available makes the magnitude of these countervailing impacts difficult
to determine, and we did not include any emissions impacts from DGS
mass reduction in our lifecycle GHG analysis of biofuels produced from
distillers sorghum oil. We invite comment on our analysis of the GHG
emissions associated with extracting sorghum oil from DGS.
---------------------------------------------------------------------------

    \25\ NSP petition, section F.2.iv
    \26\ For example, the California Air Resources Board (CARB)
estimated this impact would be approximately 10 kgCO2e/
mmBtu of biodiesel produced from distillers corn oil (https://www.arb.ca.gov/fuels/lcfs/2a2b/apps/co_bd_wdgs-rpt-102414.pdf).
Applying such an impact to our analysis of biofuels produced from
distillers sorghum oil would not change the GHG thresholds results
for the biofuels produced from distillers sorghum oil evaluated in
this document.
---------------------------------------------------------------------------

3. Feedstock Transport
    In our analysis, distillers sorghum oil is transported 50 miles by
heavy duty truck from the dry mill ethanol plant to the biodiesel or
hydrotreating facility where it is converted to transportation fuel.
GHG emissions associated with feedstock transport are relatively small,
and modest changes in transport distance are unlikely to affect the
results of our analysis.
4. Feedstock Pretreatment
    For emissions from feedstock pretreatment and fuel production, we
perform two analyses. In the first analysis, we calculate the emissions
from biodiesel produced using transesterification. In the second
analysis, we calculate the emissions from renewable diesel, jet fuel,
LPG, and naphtha, produced using hydrotreating. In Section V below, we
then explain how similar results can be inferred for heating oil.
    Before distillers sorghum oil is converted to biodiesel via
transesterification, it is processed to remove free-fatty acids. This
process requires thermal energy. Our evaluation of yellow grease for
the March 2010 RFS final rule included 14,532 Btu of natural gas per
gallon of biodiesel produced for pretreatment, and we have applied the
same assumption for this analysis. According to the NSP petition,
distillers sorghum oil has free fatty acid content near or below 15
percent, which is in the range of yellow grease free fatty acid
contents (<15 percent).\27\ This rate of thermal energy use for
pretreatment is higher than thermal energy rates used in other
lifecycle assessments EPA reviewed,\28\ and can be viewed as a
conservative assumption (i.e., resulting in higher GHG emissions).
---------------------------------------------------------------------------

    \27\ See Table 15 in the January 5, 2012 Pathways I direct final
rule (77 FR 722).
    \28\ See for example: https://www.arb.ca.gov/fuels/lcfs/2a2b/apps/co_bd_wdgs-rpt-102414.pdf.
---------------------------------------------------------------------------

    Pretreatment to remove free-fatty acids is not required when
distillers sorghum oil is used to produce renewable diesel, jet fuel,
LPG and naphtha through a hydrotreating process.
5. Fuel Production
    For biodiesel production, we used the transesterification analysis
for the March 2010 RFS rule for yellow grease biodiesel.\29\ Based on
comparison of this yellow grease analysis and the mass and energy
balance data in the NSP petition, submitted under claim of CBI, the
conversion of yellow grease and distillers sorghum oil are expected to
require similar energy inputs and yield similar amounts of biodiesel
and methanol as outputs.
---------------------------------------------------------------------------

    \29\ For details see section 2.4 of the RIA for the March 2010
RFS final rule.
---------------------------------------------------------------------------

    For production of renewable diesel, jet fuel, naphtha and LPG via a
hydrotreating process, we used the same data and approach as used in
the March 2013 Pathways I rule (78 FR 14190, March 5, 2013), and
subsequent facility-specific petitions involving hydrotreating
processes.\30\ The March 2013 Pathways I rule evaluated two
hydrotreating configurations: One optimized for renewable diesel
production and one optimized for jet fuel production. For this analysis
we evaluated a hydrotreating process maximized for renewable diesel
production, as that is the most common configuration. The jet fuel
configuration results in higher emissions (approximately 5
kgCO2e/mmBtu higher), but the threshold GHG reduction
results discussed below are not sensitive to this assumption.
---------------------------------------------------------------------------

    \30\ For determination documents responding to facility specific
petitions, see: https://www.epa.gov/renewable-fuelstandard-program/approved-pathways-renewable-fuel.
---------------------------------------------------------------------------

    Our previous analyses of hydrotreating processes have applied an
energy allocation approach for RIN-generating co-products that qualify
as renewable fuel.\31\ This approach results in higher lifecycle GHG
emissions for each of the fuel products than other approaches
considered, such as a

displacement approach, and thus can be viewed as a conservative
approach.
---------------------------------------------------------------------------

    \31\ See the March 2013 Pathways I rule, specifically 78 FR
14198-14200 (March 5, 2013).
---------------------------------------------------------------------------

    In the allocation approach, all the emissions from the
hydrotreating process are allocated across all co-products. There are a
number of ways to do the allocation, for example on the basis of
energy, mass, or economic value. Consistent with the approach taken in
the hydrotreating analysis for the March 2013 RFS rule, for this
analysis of fuels produced from distillers sorghum oil feedstock
through a hydrotreating process we allocated emissions to the renewable
diesel, naphtha and LPG based on the energy content (using lower-
heating values) of the products produced. Emissions from the process
were allocated equally to all of the Btus of fuel produced. Therefore,
on a per Btu basis, all of the primary products coming from the
hydrotreating facility have the same emissions from the fuel production
stage of the lifecycle. For this analysis, the energy content was the
most appropriate basis for allocating emissions because all of the fuel
products are used as sources of energy. Energy content also has the
advantage of being a fixed factor as opposed to market prices which
fluctuate over time.
6. Fuel Distribution
    We used the fuel distribution results from the biodiesel analysis
for the March 2010 RFS rule. Fuel distribution emissions are relatively
small compared to baseline lifecycle GHG emissions (see Table IV.3
below), and although they may be different for different types of fuel,
for the purposes of this analysis we assume that renewable diesel, jet
fuel, LPG, and naphtha, have the same fuel distribution emissions per
mmBtu of fuel used. Even if we applied a more precise value for fuel
distribution emissions, we do not expect that revision to change our
assessment that these fuels meet a 50 percent GHG emission reduction.
7. Fuel Use
    For this analysis we applied fuel use emissions factors developed
for the March 2010 RFS final rule. For biodiesel we used the biodiesel
emissions factor. For renewable diesel and jet fuel we used the
emissions factors for non-CO2 GHGs for baseline diesel fuel.
For naphtha we used the emissions factors for non-CO2 GHGs
for baseline gasoline fuel. For LPG we used the LPG non-CO2
emissions factor developed for the March 2010 RFS rule. The tailpipe
emissions are relatively small, and the threshold GHG reduction results
are not sensitive to these assumptions. More details on our analysis of
fuel use emissions are described in a memo \32\ to the rulemaking
docket.
---------------------------------------------------------------------------

    \32\ See, ``Summary of Key Assumptions for EPA's Analysis of the
Lifecycle Greenhouse Gas Emissions Associated with Biofuels Produced
from Distillers Sorghum Oil,'' Air Docket EPA-HQ-OAR-2017-0655.
---------------------------------------------------------------------------

8. Results of GHG Lifecycle Analysis
    Table IV.3 shows the lifecycle GHG emissions associated with
biofuels produced from distillers sorghum oil that result from our
assessment. The table also shows the percent reduction relative to the
petroleum baseline. All of the fuels are compared to the diesel
baseline, except for naphtha which is compared to the gasoline
baseline.

                     Table IV.3--Lifecycle GHG Emissions Associated With Biofuels Produced From Distillers Sorghum Oil (kgCO2-eq/MJ)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Renewable
                         Fuel                              Biodiesel        diesel, jet       Naphtha           LPG         2005 Diesel    2005 Gasoline
                                                                               fuel                                          baseline        baseline
--------------------------------------------------------------------------------------------------------------------------------------------------------
Production process                                     Transesterificati
                                                                      on                   Hydrotreating
                                                                    Refining
--------------------------------------------------------------------------------------------------------------------------------------------------------
Feedstock Production.................................                5.6             6.2             6.2             6.2            18.0            19.2
Feedstock Transport..................................                0.2             0.3             0.3             0.3
Feedstock Pretreatment...............................                8.4  ..............  ..............  ..............
Fuel Production......................................                1.2             8.0             8.0             8.0
Fuel Distribution....................................                0.8             0.8             0.8             0.8
Fuel Use.............................................                0.7             0.7             1.7             1.5            79.0            79.0
                                                      --------------------------------------------------------------------------------------------------
    Total............................................               17.0            16.0            17.0            16.8            97.0            98.2
--------------------------------------------------------------------------------------------------------------------------------------------------------
Percent Reduction....................................                 82              84              82              83  ..............  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------

V. Consideration of Lifecycle Analysis Results

    Based on the lifecycle GHG emissions results presented above, all
of the pathways evaluated would meet the 50 percent GHG reduction
threshold required for advanced biofuel and biomass-based diesel.
    The results presented above would also justify qualifying heating
oil produced from distillers sorghum oil as meeting the 50 percent GHG
threshold. In previous rulemakings, EPA considered the lifecycle GHG
impacts associated with heating oil and determined that heating oil
produced from a range of feedstocks (e.g., soybean oil, distillers corn
oil) via a transesterification or hydrotreating process satisfies the
50 percent lifecycle GHG reduction required for advanced biofuel.\33\
Based on the results presented above, we anticipate that biofuels such
as heating oil produced from distillers sorghum oil have significantly
lower lifecycle GHG emissions than the same fuels produced from soybean
oil, when the same production processes are used.\34\ Therefore, based
on EPA's previous lifecycle evaluations for heating oil produced from
soybean oil, we believe that heating oil produced from distillers
sorghum oil would also satisfy the 50 percent GHG reduction
requirement.
---------------------------------------------------------------------------

    \33\ See the March 2013 RFS Pathway I rule (78 FR 14190, March
5, 2013).
    \34\ For example, in analysis for the March 2010 RFS rule, EPA
found that soybean oil biodiesel achieves a 57 percent GHG reduction
(based on the mean result from our uncertainty assessment), whereas
the results in Table IV.3, above, show biodiesel produced from
distillers sorghum oil achieve a greater than 80 percent reduction.
---------------------------------------------------------------------------

VI. Summary

    Based on our GHG lifecycle evaluation described above, we propose
to find that biodiesel and heating oil produced from distillers sorghum
oil via a transesterification process, and renewable diesel, jet fuel
and heating oil produced from distillers sorghum oil via a
hydrotreating process meet the 50 percent GHG reduction threshold
requirement for advanced biofuel and biomass-based diesel. This finding

would support a determination that these fuels are eligible for
biomass-based diesel (D-code 4) RINs if they are produced through a
process that does not co-process renewable biomass and petroleum, and
for advanced biofuel (D-code 5) RINs if they are produced through a
process that does co-process renewable biomass and petroleum. EPA
invites comment on all aspects of its analysis of these proposed
biofuel pathways.

VII. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was
therefore not submitted to the Office of Management and Budget (OMB)
for review.

B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs

    This action is not expected to be an Executive Order 13771
regulatory action because this action is not significant under
Executive Order 12866.

C. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden
under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et
seq., and therefore is not subject to these requirements.

D. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. This
action will not impose any requirements on small entities. An agency
may certify that a rule will not have a significant economic impact on
a substantial number of small entities if the rule relieves regulatory
burden, has no net burden or otherwise has a positive economic effect
on the small entities subject to the rule. This rule proposes to
provide a positive economic effect for distillers sorghum oil producers
and producers of biofuels from distillers sorghum oil as they would be
able to participate in the RFS program, see CAA section 211(o).

E. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. The action imposes
no enforceable duty on any state, local or tribal governments or the
private sector.

F. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government.

G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175. This proposed rule would affect only producers
of distillers sorghum oil and producers of biofuels made from
distillers sorghum oil. Thus, Executive Order 13175 does not apply to
this action.

H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that EPA has reason to believe may disproportionately affect children,
per the definition of ``covered regulatory action'' in section 2-202 of
the Executive Order. This action is not subject to Executive Order
13045 because it because it does not concern an environmental health
risk or safety risk.

I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 because it is
not a significant regulatory action under Executive Order 12866.

J. National Technology Transfer Advancement Act (NTTAA)

    This rulemaking does not involve technical standards.

K. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    The EPA believes that this action does not have disproportionately
high and adverse human health or environmental effects on minority
populations, low-income populations and/or indigenous peoples, as
specified in Executive Order 12898 (59 FR 7629, February 16, 1994).
This proposed rule does not affect the level of protection provided to
human health or the environment by applicable air quality standards.
This action does not relax the control measures on sources regulated by
the fuel programs and RFS regulations and therefore will not cause
emissions increases from these sources.

List of Subjects in 40 CFR Part 80

    Environmental protection, Administrative practice and procedure,
Air pollution control, Diesel Fuel, Fuel additives, Gasoline, Imports,
Oil imports, Petroleum, Renewable fuel.

    Dated: December 19, 2017.
E. Scott Pruitt,
Administrator.

    For the reasons set forth in the preamble, EPA proposes to amend 40
CFR part 80 as follows:

PART 80--REGULATION OF FUEL AND FUEL ADDITIVES

0
1. The authority for part 80 continues to read as follows:

    Authority: 42 U.S.C. 7414, 7521, 7542, 7545, and 7601(a).

Subpart M--[Amended]

0
2. Section 80.1401 is amended by adding in alphabetical order a new
definition for ``distillers sorghum oil'' to read as follows:

Sec.  80.1401   Definitions.

* * * * *
    Distillers sorghum oil means oil recovered at a point downstream of
where a dry mill grain sorghum ethanol plant grinds the grain sorghum,
provided that the grain sorghum is converted to ethanol, the oil is
rendered unfit for food uses without further refining, and the
distillers grains resulting from the dry mill and oil extraction
processes are marketable as animal feed.
* * * * *
0
3. Section 80.1426, paragraph (f)(1) is amended by revising entries F,
H, and I in Table 1 to Sec.  80.1426 to read as follows:

Sec.  80.1426  How are RINs generated and assigned to batches of
renewable fuel by renewable fuel producers or importers?

* * * * *
    (f) * * *
    (1) * * *

         Table 1 to Sec.   80.1426--Applicable D Codes for Each Fuel Pathway for Use in Generating RINs
----------------------------------------------------------------------------------------------------------------
                                                                              Production process
              Entry                     Fuel type            Feedstock           requirements         D-code
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
F................................  Biodiesel,           Soy bean oil; Oil    One of the                        4
                                    renewable diesel,    from annual          following:
                                    jet fuel and         covercrops; Oil      TransEsterificatio
                                    heating oil,         from algae grown     n Hydrotreating
                                    biodiesel.           photosynthetically   Excluding
                                                         ; Biogenic waste     processes that co-
                                                         oils/fats/greases;   process renewable
                                                         Non-food grade       biomass and
                                                         corn oil; Camelina   petroleum.
                                                         sativa oil;
                                                         Distillers sorghum
                                                         oil.

                                                  * * * * * * *
H................................  Biodiesel,           Soy bean oil; Oil    One of the                        5
                                    renewable diesel,    from annual          following:
                                    jet fuel and         covercrops; Oil      TransEsterificatio
                                    heating oil.         from algae grown     n Hydrotreating
                                                         photosynthetically   Includes only
                                                         ; Biogenic waste     processes that co-
                                                         oils/fats/greases;   process renewable
                                                         Non-food grade       biomass and
                                                         corn oil; Camelina   petroleum.
                                                         sativa oil;
                                                         Distillers sorghum
                                                         oil.
I................................  Naphtha, LPG.......  Camelina sativa      Hydrotreating......               5
                                                         oil; Distillers
                                                         sorghum oil.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2017-27946 Filed 12-26-17; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 248 (Tuesday, December 27, 2016)]
[Rules and Regulations]
[Pages 95025-95026]
[FR Doc No: 2016-31082]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2016-N-0002]

New Animal Drugs; Withdrawal of Approval of New Animal Drug
Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of withdrawal.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 11 new animal drug applications (NADAs) and 4 abbreviated new animal
drug applications (ANADAs). These withdrawals of approval of NADAs and
ANADAs for antimicrobial drugs of importance to human medicine that are
administered to food-producing animals in medicated feed are being made
because the products are no longer being manufactured or marketed.
These actions are consistent with the FDA Center for Veterinary
Medicine's initiative for the Judicious Use of Antimicrobials.

DATES: Withdrawal of approval is effective December 30, 2016.

FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA is withdrawing approval of 11 NADAs and
4 ANADAs. These applications were identified as being affected by
guidance for industry (GFI) #213, ``New Animal Drugs and New Animal
Drug Combination Products Administered in or on Medicated Feed or
Drinking Water of Food-Producing Animals: Recommendations for Drug
Sponsors for Voluntarily Aligning Product Use Conditions With GFI
#209,'' December 2013 (http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM299624.pdf). Their
withdrawal of approval is consistent with the FDA Center for Veterinary
Medicine's initiative for the Judicious Use of Antimicrobials.
    Approval of the following applications for new animal drugs
administered in medicated feed is being voluntarily withdrawn at the
sponsors' requests because these products are no longer manufactured or
marketed:

------------------------------------------------------------------------
     File No.              Product name                 Sponsor
------------------------------------------------------------------------
034-085...........  LINCOMIX (lincomycin       Zoetis Inc., 333 Portage
                     hydrochloride              St., Kalamazoo, MI
                     monohydrate) Type A        49007.
                     Medicated Article.
035-287...........  OM-5 Premix                Phibro Animal Health
                     (oleandomycin) Type A      Corp., GlenPointe Centre
                     Medicated Article.         East, 3d Floor, 300
                                                Frank W. Burr Blvd.,
                                                Suite 21, Teaneck, NJ
                                                07666.
046-668...........  Penicillin G Procaine 50%  Phibro Animal Health
                     Type A Medicated Article.  Corp., GlenPointe Centre
                                                East, 3d Floor, 300
                                                Frank W. Burr Blvd.,
                                                Suite 21, Teaneck, NJ
                                                07666.
091-668...........  CHLORMAX-SP 500            Zoetis Inc., 333 Portage
                     (chlortetracycline,        St., Kalamazoo, MI
                     sulfamethazine,            49007.
                     penicillin G procaine)
                     Type A Medicated Article.
108-116...........  LINCOMIX (lincomycin)/     Phibro Animal Health
                     NICARB (nicarbazin).       Corp., GlenPointe Centre
                                                East, 3d Floor, 300
                                                Frank W. Burr Blvd.,
                                                Suite 21, Teaneck, NJ
                                                07666.
133-334...........  Virginiamycin Type A       Zoetis Inc., 333 Portage
                     Medicated Article.         St., Kalamazoo, MI
                                                49007.
139-473...........  STAFAC (virginiamycin)/    Huvepharma EOOD, 5th
                     STENEROL (halofuginone     Floor, 3A Nikolay Haytov
                     hydrobromide).             Str., 1113 Sophia,
                                                Bulgaria.
140-340...........  LINCOMIX (lincomycin)/     Huvepharma EOOD, 5th
                     STENOROL (halofuginone     Floor, 3A Nikolay Haytov
                     hydrobromide).             Str., 1113 Sophia,
                                                Bulgaria.
140-443...........  HYGROMIX 1.6 (hygromycin   Zoetis Inc., 333 Portage
                     B) Type A Medicated        St., Kalamazoo, MI
                     Article.                   49007.
140-947...........  LINCOMIX (lincomycin)/     Elanco US, Inc., 2500
                     MAXIBAN (narasin and       Innovation Way,
                     nicarbazin).               Greenfield, IN 46140.
141-090...........  STAFAC (virginiamycin)/    Huvepharma EOOD, 5th
                     CLINICOX (diclazuril).     Floor, 3A Nikolay Haytov
                                                Str., 1113 Sophia,
                                                Bulgaria.
200-171...........  LINCOMIX (lincomycin)/     Planalquimica Industrial
                     NICARMIX (nicarbazin).     Ltda., Rua das Magnolias
                                                nr. 2405, Jardim das
                                                Bandeiras, CEP 13053-
                                                120, Campinas, Sao
                                                Paulo, Brazil.
200-569...........  TYLAN (tylosin)/SACOX      Huvepharma EOOD, 5th
                     (salinomycin).             Floor, 3A Nikolay Haytov
                                                Str., 1113 Sophia,
                                                Bulgaria.
200-570...........  TYLOVET 100 (tylosin)/BIO- Huvepharma EOOD, 5th
                     COX (salinomycin).         Floor, 3A Nikolay Haytov
                                                Str., 1113 Sophia,
                                                Bulgaria.
200-580...........  TYLOVET 100 (tylosin)/     Huvepharma EOOD, 5th
                     SACOX (salinomycin).       Floor, 3A Nikolay Haytov
                                                Str., 1113 Sophia,
                                                Bulgaria.
------------------------------------------------------------------------

    Therefore, under authority delegated to the Commissioner of Food
and Drugs and redelegated to the Center for Veterinary Medicine, and in
accordance with Sec.  514.116 Notice of withdrawal of approval of
application (21 CFR 514.116), notice is given that approval of NADAs
034-085, 035-287, 046-668, 091-668, 108-116, 133-334, 139-473,

140-340, 140-443, 140-947, 141-090, 200-171, 200-569, 200-570, and 200-
580, and all supplements and amendments thereto, is hereby withdrawn,
effective December 31, 2016.
    Elsewhere in this issue of the Federal Register, FDA is amending
the animal drug regulations to reflect the voluntary withdrawal of
approval of these applications.

    Dated: December 20, 2016.
Tracey H. Forfa,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 2016-31082 Filed 12-23-16; 8:45 am]
 BILLING CODE 4164-01-P


Centers for Disease Control and Prevention (CDC).  (2021, May 24).  Demographic Trends of COVID-19 cases and deaths in the US reported to CDC: Cases by age group. https://covid.cdc.gov/covid-data-tracker/#demographics. (CDC, May 24, 2021)

Cover Sheet and List of Attachments

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[Federal Register Volume 83, Number 132 (Tuesday, July 10, 2018)]
[Rules and Regulations]
[Pages 31889-31891]
[FR Doc No: 2018-14739]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2018-0634]
RIN 1625-AA00

Safety Zone; Barge PFE-LB444, San Joaquin River, Blackslough
Landing, CA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters of the San Joaquin River due to an unstable, partially
submerged barge with hull number PFE-LB444. The temporary safety zone
is needed to protect personnel, vessels, and the marine environment
from potential hazards created by the barge and associated recovery
efforts. Entry of vessels or persons into this zone is prohibited
unless specifically authorized by the Captain of the Port San
Francisco.

DATES: This rule is effective without actual notice from July 10, 2018
until July 31, 2018. For the purposes of enforcement, actual notice
will be used from the July 3, 2018 until July 10, 2018.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2018-0634 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Junior Grade Emily K. Rowan, U.S. Coast Guard
Sector San Francisco; telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because of the emergent nature of the
situation. Notice and comment procedures would be impracticable because
immediate action is needed protect personnel, vessels, and the marine
environment from potential hazards associated with the barge and
associated recovery efforts.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. For the reasons stated above,
delaying the effective date of the rule would be impracticable.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Department
of Homeland Security Delegation No. 0170.1, which collectively
authorize the Coast Guard to establish safety zones. The Captain of the
Port San Francisco (COTP) has determined that potential hazards
associated with the barge and associated recovery efforts will be a
safety concern for anyone within a 90-yard radius of the barge. This
rule is needed to protect personnel, vessels, and the marine
environment in the navigable waters within the safety zone.

IV. Discussion of the Rule

    This rule establishes a temporary safety zone from July 3, 2018
through July 31, 2018. The safety zone will cover all navigable waters
within 90 yards of the unstable barge and associated recovery efforts
centered in approximate position 37[deg] 59'41.88'' N, 121[deg]
25'8.88'' W (NAD 83). The effect of the temporary safety zone is
intended to protect personnel, vessels, and the marine environment in
these navigable waters from potential hazards associated with the barge
and associated recovery efforts. No vessel or person will be permitted
to enter the safety zone without obtaining permission from the COTP or
a designated representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the limited
duration and narrowly tailored geographic area of the safety zone.
Although this rule restricts access to the waters encompassed by the
safety zone, the effect of this rule will not be significant because
the local waterway users will be notified via public Broadcast Notice
to Mariners to ensure the safety zone will result in minimum impact.
The entities most likely to be affected are waterfront facilities,
commercial vessels, and pleasure craft engaged in recreational
activities.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    This rule may affect the following entities, some of which may be
small entities: owners and operators of waterfront facilities,
commercial vessels, and pleasure craft engaged in recreational
activities and sightseeing, if these facilities or vessels are in the
vicinity of the safety zone at times when this zone is being enforced.
This rule will not have a significant economic impact on a substantial
number of small entities for the following reasons: (i) This rule will
encompass only a small portion of the waterway for a limited period of
time, and (ii) the maritime public will be advised in advance of these
safety zones via Broadcast Notice to Mariners.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to

the Small Business and Agriculture Regulatory Enforcement Ombudsman and
the Regional Small Business Regulatory Fairness Boards. The Ombudsman
evaluates these actions annually and rates each agency's responsiveness
to small business. If you wish to comment on actions by employees of
the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard
will not retaliate against small entities that question or complain
about this rule or any policy or action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Commandant Instruction M16475.1D, which guide the
Coast Guard in complying with the National Environmental Policy Act of
1969 (42 U.S.C. 4321-4370f), and have determined that this action is
one of a category of actions that do not individually or cumulatively
have a significant effect on the human environment. This rule involves
safety zone of limited size and duration. It is categorically excluded
from further review under Categorical Exclusion L60(d) of Appendix A,
Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of
Environmental Consideration supporting this determination is available
in the docket where indicated under ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T11-936 to read as follows:

Sec.  165.T11-936  Safety Zone; Barge PFE-LB444, San Joaquin River,
Blackslough Landing, CA.

    (a) Location. The following area is a safety zone: all navigable
waters within 90 yards of the unstable, partially submerged barge and
associated recovery efforts centered in approximate position 37[deg]59'
41.88'' N, 121[deg]25'8.88'' W (NAD 83).
    (b) Enforcement period. The zone described in paragraph (a) of this
section will be enforced from July 3, 2018 through July 31, 2018. The
Captain of the Port San Francisco (COTP) will notify the maritime
community of periods during which these zones will be enforced via
Broadcast Notice to Mariners in accordance with Sec.  165.7.
    (c) Definitions. As used in this section, ``designated
representative'' means a Coast Guard Patrol Commander, including a
Coast Guard coxswain, petty officer, or other officer on a Coast Guard
vessel or a Federal, State, or local officer designated by or assisting
the COTP in the enforcement of the safety zone.
    (d) Regulations. (1) Under the general regulations in subpart C of
this part, entry into, transiting or anchoring within this safety zone
is prohibited unless authorized by the COTP or the COTP's designated
representative.
    (2) The safety zone is closed to all vessel traffic, except as may
be permitted by the COTP or a designated representative.
    (3) Vessel operators desiring to enter or operate within the safety
zone must contact the COTP or a designated representative to obtain
permission to do so. Vessel operators given permission to enter or
operate in the safety zone must comply with all directions given to
them by the COTP or a designated representative. Persons and vessels
may request permission to enter the safety zones on VHF-23A or through
the 24-hour Command Center at telephone<PHONE_NUMBER>.

    Dated: July 3, 2018.
Anthony J. Ceraolo,
Captain, U.S. Coast Guard, Captain of the Port, San Francisco.
[FR Doc. 2018-14739 Filed 7-9-18; 8:45 am]
 BILLING CODE 9110-04-P