inputs along with emission factors to estimate the GHG emissions from
this process. The energy inputs and electricity credits are shown in
Table 10, below. These inputs are based on Confidential Business
Information (CBI), rounded to the nearest 1000 units, provided by
industry as part of the petition process for new fuel pathways.
---------------------------------------------------------------------------

    \59\ Hydrogen emissions are modeled as natural gas and
electricity demands.

                                Table 10--2022 Energy Use at Cellulosic Facility
                                                    [Btu/gal]
----------------------------------------------------------------------------------------------------------------
                                                                    Natural gas      Purchased         Sold
                   Technology                       Biomass use         use         electricity     electricity
----------------------------------------------------------------------------------------------------------------
Biochemical Fermentation to Renewable Gasoline            49,000          59,000               0          -2,000
 or Renewable Gasoline Blendstock via Carboxylic
 Acid...........................................
----------------------------------------------------------------------------------------------------------------

    The process also uses a small amount of buffer material as
neutralizer which was not included in the GHG lifecycle results due to
its likely negligible emissions impact. The GHG emissions estimates
from the fuel production stage are seen in Table 11.

   Table 11--Fuel Production Emissions for Biochemical Fermentation to
 Renewable Gasoline or Renewable Gasoline Blendstock via Carboxylic Acid
                            Using Corn Stover
------------------------------------------------------------------------
                                                  GHG Emissions  (g CO2-
                Lifecycle stage                         eq./mmBtu)
------------------------------------------------------------------------
On-Site & Upstream Emissions (Natural Gas &                       33,000
 Biomass*).....................................
Electricity Co-Product Credit..................                   -3,000
Total Fuel Production Emissions:...............                   30,000
------------------------------------------------------------------------
* Only non-CO2 combustion emissions from biomass

c. Biological Conversion to Renewable Gasoline and Renewable Gasoline
Blendstock
    The third production process we investigated involves the use of
microorganisms to biologically convert sugars hydrolyzed from cellulose
directly into hydrocarbons which could be either a complete fuel as
renewable gasoline or a renewable gasoline blendstock. The process is
similar to the biochemical fermentation to ethanol pathway modeled for
the final rule with the major difference being the end fuel product,
hydrocarbons instead of ethanol. Researchers believe that this new
technology could achieve improvements over classical fermentation
approaches because hydrocarbons generally separate spontaneously from
the aqueous phase, thereby avoiding poisoning of microbes by the
accumulated products and facilitating separation/collection of
hydrocarbons from the reaction medium. In other words, some energy
savings may result because fewer separation unit operations could be
required for separating the final product from other reactants and
there may be better conversion yields as the fermentation
microorganisms are not poisoned when interacting with accumulated
products. We also expect that the lignin/byproduct portions of the
biomass from the fermentation to hydrocarbon process could be converted
into heat and electricity for internal demands or for export, similar
to the biochemical fermentation to ethanol pathway.
    Therefore, we can conservatively extend our final March 2010 RFS
rule biochemical fermentation to ethanol process results to a similar
(but likely slightly improved) process that instead produces
hydrocarbons. Since the final rule cellulosic ethanol GHG results were
well above the 60% GHG reduction threshold for cellulosic biofuels, if
actual emissions from other necessary changes to the direct biochemical
fermentation to hydrocarbons process represent some small increment in
GHG emissions, the pathway would still likely meet the threshold. Table
12 is our qualitative assessment of the potential emissions reductions
from a process using biochemical fermentation to cellulosic
hydrocarbons assuming similarities to the biochemical fermentation to
cellulosic ethanol route from the final rule.

    Table 12--Fuel Production Emissions for March 2010 RFS Cellulosic Biochemical Ethanol Compared to Direct
        Biochemical Fermentation to Renewable Gasoline or Renewable Gasoline Blendstock Using Corn Stover
----------------------------------------------------------------------------------------------------------------
                                                                                Direct biochemical
                                                                                fermentation to
                                                                 Cellulosic biochemical  renewable gasoline  and
                        Lifecycle stage                           ethanol emissions (g     renewable  gasoline
                                                                     CO2-eq./mmBtu)        blendstock emissions
                                                                                (g CO2-eq./mmBtu)
----------------------------------------------------------------------------------------------------------------
On-Site Emissions & Upstream (biomass)........................                    3,000             < or = 3,000
Electricity Co-Product Credit.................................                  -35,000                = -35,000
Total Fuel Production Emissions \60\:.........................                  -33,000           < or = -33,000
----------------------------------------------------------------------------------------------------------------

    Table 13 below breaks down by stage the lifecycle GHG emissions for
the renewable gasoline and renewable gasoline blendstock pathways using
corn stover and the 2005 petroleum baseline. The table demonstrates the
contribution of each stage in the fuel pathway and its relative
significance in terms of GHG emissions. These results are also
presented in graphical form in a supplemental memorandum to the
docket.\61\ As noted above, these analyses assume natural gas as the
process energy when needed; using biogas as process energy would result
in an even better lifecycle GHG impact.
---------------------------------------------------------------------------

    \60\ Numbers do not add up due to rounding.
    \61\ Memorandum to the Air and Radiation Docket EPA-HQ-OAR-2011-
0542 ``Supplemental Information for Renewable Gasoline and Renewable
Gasoline Blendstock Pathways Under the Renewable Fuel Standard
(RFS2) Program''.

 Table 13--Lifecycle GHG Emissions for Renewable Gasoline and Renewable Gasoline Blendstock Pathways Using Corn
                                                  Stover, 2022
                                               [kg CO2-eq./mmBtu]
----------------------------------------------------------------------------------------------------------------
                                                                    Biochemical
                                                     Catalytic     fermentation       Direct
                                                   pyrolysis and   to renewable     biochemical
                                                    upgrade to     gasoline and    fermentation
                    Fuel type                        renewable       renewable     to renewable    2005 gasoline
                                                   gasoline and      gasoline      gasoline and      baseline
                                                     renewable    blendstock via     renewable
                                                     gasoline       carboxylic       gasoline
                                                    blendstock         acid         blendstock
----------------------------------------------------------------------------------------------------------------
Net Domestic Agriculture (w/o land use change)..               9               8            ~ 11  ..............
Net International Agriculture (w/o land use       ..............  ..............  ..............  ..............
 change)........................................
Domestic Land Use Change........................              -9              -8           ~ -11  ..............
International Land Use Change...................  ..............  ..............  ..............  ..............
Fuel Production.................................              28              30      < or = -33              19
Fuel and Feedstock Transport....................               2               2             ~ 2               *
Tailpipe Emissions..............................               2               2             ~ 1              79
                                                 ---------------------------------------------------------------
    Total Emissions.............................              32              34      < or = -29              98

% Change from Baseline..........................            -67%            -65%           -129%  ..............
----------------------------------------------------------------------------------------------------------------
* Emissions included in fuel production stage.

d. Extension of Modeling Results to Other Production Processes
Producing Renewable Gasoline or Renewable Gasoline Blendstock
    In the March 2010 RFS rulemaking, we modeled the GHG emissions
results from the biochemical fermentation process to ethanol,
thermochemical gasification processes to mixed alcohols (primarily
ethanol) and mixed hydrocarbons (primarily diesel fuel). We extended
these modeled process results to apply when the biofuel was produced
from ``any'' process. We determined that since we modeled multiple
cellulosic biofuel processes and all were shown to exceed the 60%
lifecycle GHG threshold requirements for cellulosic biofuel using the
specified feedstocks its was reasonable to extend to other processes
(e.g. additional thermo-catalytic hydrodeoxygenation routes with
upgrading similar to pyrolysis and aqueous phase processing) that might
develop as these would likely represent improvements over existing
processes as the industry works to improve the economics of cellulosic
biofuel production by, for example, reducing energy consumption and
improving process yields. Similarly, this rule assesses multiple
processes for the production of renewable gasoline and renewable
gasoline blendstocks and all were shown to exceed the 60% lifecycle GHG
threshold requirements for cellulosic biofuel using specified
feedstocks.
    As was the case in our earlier rulemaking, a couple reasons in
particular support extending our modeling results to other production
process producing renewable gasoline or renewable gasoline blendstock
from cellulosic feedstock. Under this rule we analyzed the core
technologies most likely available through 2022 for production of
renewable gasoline and renewable gasoline blendstock routes from
cellulosic feedstock as shown in literature. 62
63 The two primary routes for renewable gasoline and
renewable gasoline blendstock production from cellulosic feedstock can
be classified as either thermochemical or biological. Each of these two
major categories has two subcategories. The processes under the
thermochemical category include:
---------------------------------------------------------------------------

    \62\ Regalbuto, John. ``An NSF perspective on next generation
hydrocarbon biorefineries,'' Computers and Chemical Engineering 34
(2010) 1393-1396. February 2010.
    \63\ Serrano-Ruiz, J., Dumesic, James. ``Catalytic routes for
the conversion of biomass into liquid hydrocarbon transportation
fuels,'' Energy Environmental Science (2011) 4, 83-99.
---------------------------------------------------------------------------

     Pyrolysis and Upgrading--in which cellulosic biomass is
decomposed with temperature to bio-oils and requires further catalytic
processing to produce a finished fuel
     Gasification--in which cellulosic biomass is decomposed to
syngas with further catalytic processing of methanol to gasoline or
through Fischer-Tropsch (F-T) synthesis to gasoline

The processes under the biochemical category include:
     Biological conversion to hydrocarbons--requires the
release of sugars from biomass and microorganisms to biologically
convert sugars straight into hydrocarbons instead of alcohols
     Catalytic upgrading of biochemically produced
intermediates--requires the release of sugars from biomass and aqueous-
or liquid-phase processing of sugars or biochemically produced
intermediate products into hydrocarbons using solid catalysts,
    As part of the modeling effort here, as well as for the March 2010
RFS final rule, we have considered the lifecycle GHG impacts of the
four possible production technologies mentioned above. The pyrolysis
and upgrading, direct biological conversion, and catalytic upgrading of
biochemically produced intermediates are considered in this rule and
the gasification route was already included in the March 2010 final
rule. In all cases, the processes that we have considered meet the 60%
lifecycle GHG reduction required for cellulosic biofuels. Furthermore,
we believe that the results from our modeling would cover all the
likely variations within these potential routes for producing renewable
gasoline and renewable gasoline blendstock which also use natural gas,
biogas or biomass \64\ for process energy and that all such production
variations would also meet the 60% lifecycle threshold.\65\
---------------------------------------------------------------------------

    \64\ Our lifecycle analysis assumes that producers would use the
same type of biomass as both the feedstock and the process energy.
    \65\ One commenter wanted clarification of the term ``process
energy'' as it applies to the production of renewable gasoline. The
EPA did not intend for the term, ``process energy'', to include
other energy sources, such as electricity to provide power for
ancillary processes, such as lights, small pumps, computers, and
other small support equipment.
---------------------------------------------------------------------------

    The main reason for this is that we believe that our energy input
assumptions are reasonable at this time but probably in some cases are
conservatively high for commercial scale cellulosic facilities. The
cellulosic industry is in its early stages of development and many of
the estimates of process technology GHG impacts is based on pre-
commercial scale assessments and demonstration programs. Commercial
scale cellulosic facilities will continue to make efficiency
improvements over time to maximize their fuel products/co-products and
minimize wastes. For cellulosic facilities, such improvements include
increasing conversion yields and fully utilizing the biomass input for
valuable products.
    An example of increasing the amount of biomass utilized is the
combustion of undigested or unconverted biomass for heat and power. The
three routes that we analyzed for the production of renewable gasoline
and renewable gasoline blendstock in today's rule assume an electricity
production credit from the economically-driven use of lignin or waste
byproducts; we also ran

a sensitivity case where no electricity credit was given. We found that
all of the routes analyzed would still pass the GHG threshold without
an electricity credit, providing confidence that over the range of
technology options, these process technologies will surely allow the
cellulosic biofuel produced to exceed the threshold for cellulosic
biofuel GHG performance. Without excess electricity production the
catalytic pyrolysis pathway results in a 65% lifecycle GHG reduction,
the biochemical fermentation via carboxylic acid pathway results in a
62% lifecycle GHG reduction, and the direct biochemical fermentation
pathway results in a 93% reduction in lifecycle GHG emissions compared
to the petroleum fuel baseline.
    Additionally, while the final results reported in this rule include
an electricity credit, this electricity credit is based on current
technology for generating electricity; it is possible that over the
next decade as cellulosic biofuel production matures, the efficiency
with which electricity is generated at these facilities will also
improve. Such efficiency improvements will tend to improve the GHG
performance for cellulosic biofuel technologies in general including
those used to produce renewable gasoline.
    Furthermore, industry has identified other areas for energy
improvements which our current pathway analyses do not include.
Therefore, the results we have come up with for the individual pathway
types represent conservative estimates and any variations in the
pathways considered are likely to result in greater GHG reductions than
what is considered here. For example, the variation of the catalytic
pyrolysis route considered here resulted in a 67% reduction in
lifecycle GHG emissions compared to the petroleum baseline. However, as
was mentioned this was based on data from our NREL modeling and
industry CBI data indicated more efficient energy performance which, if
realized, would improve GHG performance. Another area for improvement
in this pathway could be the use of anaerobic digestion to treat
organics in waste water. If the anaerobic digestion is on-site, then
enough biogas could potentially be produced to replace all of the
fossil natural gas used as fuel and about half the natural gas fed for
hydrogen production.\66\ Thus, fossil natural gas consumption could be
further minimized under certain scenarios. We believe that as
commercial scale cellulosic facilities develop, more of these
improvements will be made to maximize the use of all the biomass and
waste byproducts available to bring the facility closer to energy self-
sufficiency. These improvements could help to increase the economic
profitability for cellulosic facilities where fossil energy inputs
become costly to purchase. Therefore we can extend the modeling results
for our pyrolysis route to all variations of this production technology
which use natural gas, biogas or biomass for production energy for
producing renewable gasoline or renewable gasoline blendstock.
---------------------------------------------------------------------------

    \66\ Kinchin, Christopher. Catalytic Fast Pyrolysis with
Upgrading to Gasoline and Diesel Blendstocks. National Renewable
Energy Laboratory (NREL). 2011.
---------------------------------------------------------------------------

    The F-T gasification technology route considered as part of the
March 2010 RFS final rule resulted in an approximately 91% reduction in
lifecycle GHG emissions compared to the petroleum baseline. This could
be considered a conservatively high estimate as the process did not
assume any excess electricity production, which as mentioned above
could lead to additional GHG reductions. The F-T process involves
gasifying biomass into syngas (mix of H2 and CO) and then
converting the syngas through a catalytic process into a hydrocarbon
mix that is further refined into finished product. The F-T process
considered was based on producing both gasoline and diesel fuel so that
it was not optimized for renewable gasoline production. A process for
producing primarily renewable gasoline rather than diesel from a
gasification route should not result in a significantly worse GHG
impacts compared to the mixed fuel process analyzed. Furthermore, as
the lifecycle GHG reduction from the F-T process considered was around
91%, there is considerable room for variations in this route to still
meet the 60% lifecycle GHG reduction threshold for cellulosic fuels.
Therefore, in addition to the F-T process originally analyzed for
producing naphtha, we can extend the results based on the above
analyses to include all variations of the gasification route which use
natural gas, biogas or biomass for production energy for producing
renewable gasoline or renewable gasoline blendstock. These variations
include for example different catalysts and different refining
processes to produce different mixes of final fuel product. While the
current Table 1 entry in the regulations does not specify process
energy sources, we are adding these specific eligible energy sources
since we have not analyzed other energy sources (e.g., coal) as also
allowing the pathway to meet the GHG performance threshold.
    There is an even wider gap between the results modeled for the
direct fermentation route and the cellulosic lifecycle GHG threshold.
The variation we considered for the direct fermentation process
resulted in an approximately 129% reduction in lifecycle GHG emissions
compared to the petroleum baseline. This process did consider
production of electricity as part of the process but as mentioned even
if this was not the case the pathway would still easily fall below the
60% lifecycle threshold for cellulosic biofuels. If actual emissions
from other necessary changes to the direct biochemical fermentation to
hydrocarbons process represent some small increment in GHG emissions,
the pathway would still likely meet the threshold. Therefore, we can
extend the results to all variations of the direct biochemical route
for renewable gasoline or renewable gasoline blendstock production
which use natural gas, biogas or biomass for production energy.
    The biochemical with catalytic upgrading route that we evaluated
resulted in a 65% reduction in GHG emissions compared to the petroleum
baseline. However, this can be considered a conservatively high
estimate. For instance, the biochemical fermentation to gasoline via
carboxylic acid route considered did not include the potential for
generating steam from the combustion of undigested biomass and then
using this steam for process energy. If this had been included, natural
gas consumption could potentially be decreased which would lower the
potential GHG emissions estimated from the process. Therefore, the
scenario analyzed could be considered conservative in estimating actual
natural gas usage. As was the case with the pyrolysis route considered,
we believe that as commercial scale cellulosic facilities develop,
improvements will be made to maximize the use of all the biomass and
waste byproducts available to bring the facility closer to energy self-
sufficiency. These improvements help to increase the economic
profitability for cellulosic facilities where fossil energy inputs
become costly to purchase. The processes we analyzed for this
rulemaking utilized a mix of natural gas and biomass for process
energy, with biogas replacing natural gas providing improved GHG
performance. We have not analyzed other fuel types (e.g., coal) and are
therefore not approving processes that utilized other fuel sources at
this point. Therefore, we are

extending our results to include all variations of the biochemical with
catalytic upgrading process utilizing natural gas, biogas or biomass
for process energy.
    While actual cellulosic facilities may show some modifications to
the process scenarios we have already analyzed, our results give a good
indication of the range of emissions we could expect from processes
producing renewable gasoline and renewable gasoline blendstock from
cellulosic feedstock, all of which meet the 60% cellulosic biofuel
threshold (assuming they are utilizing natural gas, biogas or biomass
for process energy). Technology changes in the future are likely to
increase efficiency to maximize profits, while also lowering lifecycle
GHG emissions. Therefore, we have concluded that since all of the
renewable gasoline or renewable gasoline blendstock fuel processing
methods we have analyzed exceed the 60% threshold using specific
cellulosic feedstock types, we can conclude that processes producing
renewable gasoline or renewable gasoline blendstock that fit within the
categories of process analyzed here and are produced from the same
feedstock types and using natural gas, biogas or biomass for process
energy use will also meet the 60% GHG reduction threshold. In addition,
while other technologies may develop, we expect that they will only
become commercially competitive if they have better yields (more
gallons per ton of feedstock) or lower production costs due to lower
energy consumption. Both of these factors would suggest better GHG
performance. This would certainly be the case if such processes also
relied upon using biogas and/or biomass as the primary energy source.
Therefore based on our review of the existing primary cellulosic
biofuel production processes, likely GHG emission improvements for
existing or new technologies, and consideration of the positive GHG
emissions benefits associated with using biogas and/or biomass for
process energy, we are approving for cellulosic RIN generation any
process for renewable gasoline and renewable gasoline blendstock
production using specified cellulosic biomass feedstocks as long as the
process utilizes biogas and/or biomass for all process energy.
5. Summary
    Three renewable gasoline and renewable gasoline blendstock pathways
were compared to baseline petroleum gasoline, using the same value for
baseline gasoline as in the March 2010 RFS final rule analysis. The
results of the analysis indicate that the renewable gasoline and
renewable gasoline blendstock pathways result in a GHG emissions
reduction of 65-129% or better compared to the gasoline fuel it would
replace using corn stover as a feedstock. The renewable gasoline and
renewable gasoline blendstock pathways which use corn stover as a
feedstock all exceed the 60% lifecycle GHG threshold requirements for
cellulosic biofuel, these pathways capture the likely current
technologies, and future technology improvements are likely to increase
efficiency and lower GHG emissions. Therefore we have determined that
all processes producing renewable gasoline or renewable gasoline
blendstock from corn stover can qualify if they fall in the following
process characterizations:
     Catalytic pyrolysis and upgrading utilizing natural gas,
biogas, and/or biomass as the only process energy sources
     Gasification and upgrading utilizing natural gas, biogas,
and/or biomass as the only process energy sources
     Thermo-catalytic hydrodeoxygenation processes such as
aqueous phase processing with upgrading sufficiently similar to
pyrolysis and gasification
     Direct fermentation utilizing natural gas, biogas, and/or
biomass as the only process energy sources
     Fermentation and upgrading utilizing natural gas, biogas,
and/or biomass as the only process energy sources
     Any process utilizing biogas and/or biomass as the only
process energy sources.
    As was the case for extending corn stover results to other
feedstocks in the March 2010 RFS final rule, these results are also
reasonably extended to feedstocks with similar or lower GHG emissions
profiles, including the following feedstocks:
     Cellulosic biomass from crop residue, slash, pre-
commercial thinnings and tree residue, annual cover crops;
     Cellulosic components of separated yard waste;
     Cellulosic components of separated food waste; and
     Cellulosic components of separated MSW
    For more information on the reasoning for extension to these other
feedstocks refer to the feedstock production and distribution section
or the March 2010 RFS rulemaking (75 FR 14670).
    Based on these results, today's rule includes pathways for the
generation of cellulosic biofuel RINs for renewable gasoline or
renewable gasoline blendstock produced by catalytic pyrolysis and
upgrading, gasification and upgrading, other similar thermo-catalytic
hydrodeoxygenation routes with upgrading, direct fermentation,
fermentation and upgrading, all utilizing natural gas, biogas, and/or
biomass as the only process energy sources or any process utilizing
biogas and/or biomass as the only energy sources, and using corn stover
as a feedstock or the feedstocks noted above. In order to qualify for
RIN generation, the fuel must meet the other definitional criteria for
renewable fuel (e.g., produced from renewable biomass, and used to
reduce or replace petroleum-based transportation fuel, heating oil or
jet fuel) specified in the Clean Air Act and the RFS regulations.
    A manufacturer of a renewable motor vehicle gasoline (including
parties using a renewable blendstock obtained from another party), must
satisfy EPA motor vehicle registration requirements in 40 CFR part 79
for the fuel to be used as a transportation fuel. Per 40 CFR
79.56(e)(3)(i), a renewable motor vehicle gasoline would be in the Non-
Baseline Gasoline category or the Atypical Gasoline category (depending
on its properties) since it is not derived only from conventional
petroleum, heavy oil deposits, coal, tar sands and/or oil sands (40 CFR
79.56(e)(3)(i)(5)). In either case, the Tier 1 requirements at 40 CFR
79.52 (emissions characterization) and the Tier 2 requirements at 40
CFR 79.53 (animal exposure) are conditions for registration unless the
manufacturer qualifies for a small business provision at 40 CFR
79.58(d). For a non-baseline gasoline, a manufacturer under $50 million
in annual revenue is exempt from Tier 1 and Tier 2. For an atypical
gasoline there is no exemption from Tier 1, but a manufacturer under
$10 million in annual revenue is exempt from Tier 2.
    Registration for a motor vehicle gasoline at 40 CFR 79 is via EPA
Form 3520-12, Fuel Manufacturer Notification for Motor Vehicle Fuel,
available at: http://www.epa.gov/otaq/regs/fuels/ffarsfrms.htm.

D. Esterification Production Process Inclusion for Specified Feedstocks
Producing Biodiesel

    The Agency is not taking final action at this time on its proposed
inclusion of the process ``esterification'' as an approved biodiesel
production process in Table 1 to Sec.  40 CFR 80.1426. See 77 FR 465.
We continue to evaluate the issue and anticipate issuing a final
determination as part of a subsequent rulemaking.

III. Additional Changes to Listing of Available Pathways in Table 1 of
80.1426

    We are also finalizing two changes to Table 1 to 80.1426 that were
proposed on July 1, 2011(76 FR 38844). The first change adds ID letters
to pathways to facilitate references to specific pathways. The second
change adds ``rapeseed'' to the existing pathway for renewable fuel
made from canola oil.
    On September 28, 2010, EPA published a ``Supplemental Determination
for Renewable Fuels Produced Under the Final RFS2 Program from Canola
Oil'' (75 FR 59622). In the July 1, 2011 NPRM (76 FR 38844) we proposed
to clarify two aspects of the supplemental determination. First we
proposed to amend the regulatory language in Table 1 to Sec.  80.1426
to clarify that the currently-approved pathway for canola also applies
more generally to rapeseed. While ``canola'' was specifically described
as the feedstock evaluated in the supplemental determination, we had
not intended the supplemental determination to cover just those
varieties or sources of rapeseed that are identified as canola, but to
all rapeseed. As described in the July 1, 2011 NPRM, we currently
interpret the reference to ``canola'' in Table 1 to Sec.  80.1426 to
include any rapeseed. To eliminate ambiguity caused by the current
language, however, we proposed to replace the term ``canola'' in that
table with the term ``canola/rapeseed''. Canola is a type of rapeseed.
While the term ``canola'' is often used in the American continent and
in Australia, the term ``rapeseed'' is often used in Europe and other
countries to describe the same crop. We received no adverse comments on
our proposal, and are finalizing it as proposed. This change will
enhance the clarity of the regulations regarding the feedstocks that
qualify under the approved canola biodiesel pathway.
    Second, we wish to clarify that although the GHG emissions of
producing fuels from canola feedstock grown in the U.S. and Canada was
specifically modeled as the most likely source of canola (or rapeseed)
oil used for biodiesel produced for sale and use in the U.S., we also
intended that the approved pathway cover canola/rapeseed oil from other
countries, and we interpret our regulations in that manner. We expect
the vast majority of biodiesel used in the U.S. and produced from
canola/rapeseed oil will come from U.S. and Canadian crops. Incidental
amounts from crops produced in other nations will not impact our
average GHG emissions for two reasons. First, our analyses considered
world-wide impacts and thus considered canola/rapeseed crop production
in other countries. Second, other countries most likely to be exporting
canola/rapeseed or biodiesel product from canola/rapeseed are likely to
be major producers which typically use similar cultivars and farming
techniques. Therefore, GHG emissions from producing biodiesel with
canola/rapeseed grown in other countries should be very similar to the
GHG emissions we modeled for Canadian and U.S. canola, though they
could be slightly (and insignificantly) higher or lower. At any rate,
even if there were unexpected larger differences, EPA believes the
small amounts of feedstock or fuel potentially coming from other
countries will not impact our threshold analysis. Therefore, EPA
interprets the approved canola pathway as covering canola/rapeseed
regardless of country of origin.
    We are also correcting an inadvertent omission to the proposal
which incorrectly did not include a pathway for producing naphtha from
switchgrass and miscanthus; this pathway was included in the original
March 2010 RFS final rule. This pathway also incorporates the
additional energy grass feedstock sources being added today, namely
energy cane.

IV. Statutory and Executive Order Reviews

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

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is a ``significant regulatory action.'' Accordingly, EPA
submitted this action to the Office of Management and Budget (OMB) for
review under Executive Orders 12866 and 13563 (76 FR 3821, January 21,
2011) and any changes made in response to OMB recommendations have been
documented in the docket for this action.

B. Paperwork Reduction Act

    This action does not impose any new information collection burden.
The corrections, clarifications, and modifications to the final March
2010 RFS regulations contained in this rule are within the scope of the
information collection requirements submitted to the Office of
Management and Budget (OMB) for the final March 2010 RFS regulations.
    OMB has approved the information collection requirements contained
in the existing regulations at 40 CFR part 80, subpart M under the
provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and
has assigned OMB control numbers 2060- 0637 and 2060-0640. The OMB
control numbers for EPA's regulations in 40 CFR are listed in 40 CFR
part 9.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statute unless the agency certifies that the
rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
    For purposes of assessing the impacts of today's rule on small
entities, small entity is defined as: (1) A small business as defined
by the Small Business Administration's (SBA) regulations at 13 CFR
121.201; (2) a small governmental jurisdiction that is a government of
a city, county, town, school district or special district with a
population of less than 50,000; and (3) a small organization that is
any not-for-profit enterprise which is independently owned and operated
and is not dominant in its field.
    After considering the economic impacts of this action on small
entities, I certify that this rule will not have a significant economic
impact on a substantial number of small entities. This rule will not
impose any new requirements on small entities. The relatively minor
corrections and modifications this rule makes to the final March 2010
RFS regulations do not impact small entities.

D. Unfunded Mandates Reform Act

    This rule does not contain a Federal mandate that may result in
expenditures of $100 million or more for State, local, and tribal
governments, in the aggregate, or the private sector in any one year.
We have determined that this action will not result in expenditures of
$100 million or more for the above parties and thus, this rule is not
subject to the requirements of sections 202 or 205 of UMRA.
    This rule is also not subject to the requirements of section 203 of
UMRA because it contains no regulatory requirements that might
significantly or uniquely affect small governments. It only applies to
gasoline, diesel, and renewable fuel producers, importers, distributors
and marketers and makes

relatively minor corrections and modifications to the RFS regulations.

E. 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, as
specified in Executive Order 13132. This action only applies to
gasoline, diesel, and renewable fuel producers, importers, distributors
and marketers and makes relatively minor corrections and modifications
to the RFS regulations. Thus, Executive Order 13132 does not apply to
this action.

F. Executive Order 13175 (Consultation and Coordination With Indian
Tribal Governments)

    This rule does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). It applies to
gasoline, diesel, and renewable fuel producers, importers, distributors
and marketers. This action makes relatively minor corrections and
modifications to the RFS regulations, and does not impose any
enforceable duties on communities of Indian tribal governments. Thus,
Executive Order 13175 does not apply to this action.

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

    EPA interprets EO 13045 (62 FR 19885, April 23, 1997) as applying
only to those regulatory actions that concern health or safety risks,
such that the analysis required under section 5-501 of the EO has the
potential to influence the regulation. This action is not subject to EO
13045 because it does not establish an environmental standard intended
to mitigate health or safety risks.

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

    This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355 (May 22, 2001)), because it is not
likely to have a significant adverse effect on the supply,
distribution, or use of energy. This rulemaking does not change any
programmatic structural component of the RFS regulatory requirements.
This rulemaking does not add any new requirements for obligated parties
under the program or mandate the use of any of the new pathways
contained in the rule. This rulemaking only makes a determination to
qualify new fuel pathways under the RFS regulations, creating further
opportunity and flexibility for compliance with the Energy Independence
and Security Act of 2007 (EISA) mandates.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law 104-113, 12(d) (15 U.S.C. 272 note)
directs EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
voluntary consensus standards bodies. NTTAA directs EPA to provide
Congress, through OMB, explanations when the Agency decides not to use
available and applicable voluntary consensus standards.
    This action does not involve technical standards. Therefore, EPA
did not consider the use of any voluntary consensus standards.

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

    Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes
Federal executive policy on environmental justice. Its main provision
directs Federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA has determined that this rule will not have disproportionately
high and adverse human health or environmental effects on minority or
low-income populations because it does not affect the level of
protection provided to human health or the environment. These
amendments would not relax the control measures on sources regulated by
the RFS regulations and therefore would not cause emissions increases
from these sources.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. A major rule cannot take effect until 60 days after it
is published in the Federal Register. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of the rule the Federal Register.
This action is not a ``major rule'' as defined by 5 U.S.C. 804(2).

V. Statutory Provisions and Legal Authority

    Statutory authority for the rule finalized today can be found in
section 211 of the Clean Air Act, 42 U.S.C. 7545. Additional support
for today's rule comes from Section 301(a) of the Clean Air Act, 42
U.S.C. 7414, 7542, and 7601(a).

List of Subjects in 40 CFR Part 80

    Environmental protection, Administrative practice and procedure,
Agriculture, Air pollution control, Confidential business information,
Diesel Fuel, Energy, Forest and Forest Products, Fuel additives,
Gasoline, Imports, Labeling, Motor vehicle pollution, Penalties,
Petroleum, Reporting and recordkeeping requirements.

    Dated: February 22, 2013.
Bob Perciasepe,
Acting Administrator.
    For the reasons set forth in the preamble, 40 CFR part 80 is
amended as follows:

PART 80--REGULATION OF FUELS AND FUEL ADDITIVES

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

    Authority:  42 U.S.C. 7414, 7521(1), 7545 and 7601(a).

0
2. Section 80.1401 is amended by adding definitions of ``Energy cane,''
``Renewable gasoline'' and ``Renewable gasoline blendstock'' in
alphabetical order to read as follows:

Sec.  80.1401  Definitions.

* * * * *
    Energy cane means a complex hybrid in the Saccharum genus that has
been bred to maximize cellulosic rather than sugar content. For the
purposes of this section, energy cane excludes the species Saccharum
spontaneum, but includes hybrids derived from S.

spontaneum that have been developed and publicly released by USDA.
* * * * *
    Renewable gasoline means renewable fuel made from renewable biomass
that is composed of only hydrocarbons and which meets the definition of
gasoline in Sec.  80.2(c).
    Renewable gasoline blendstock means a blendstock made from
renewable biomass that is composed of only hydrocarbons and which meets
the definition of gasoline blendstock in Sec.  80.2(s).
* * * * *

0
3. Section 80.1426 is amended by revising Table 1 in paragraph (f)(1)
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
                       Fuel type                   Feedstock                   requirements             D-Code
----------------------------------------------------------------------------------------------------------------
A.............  Ethanol................  Corn starch.................  All of the following: Dry               6
                                                                        mill process, using natural
                                                                        gas, biomass, or biogas for
                                                                        process energy and at least
                                                                        two advanced technologies
                                                                        from Table 2 to this
                                                                        section.
B.............  Ethanol................  Corn starch.................  All of the following: Dry               6
                                                                        mill process, using natural
                                                                        gas, biomass, or biogas for
                                                                        process energy and at least
                                                                        one of the advanced
                                                                        technologies from Table 2
                                                                        to this section plus drying
                                                                        no more than 65% of the
                                                                        distillers grains with
                                                                        solubles it markets
                                                                        annually.
C.............  Ethanol................  Corn starch.................  All of the following: Dry               6
                                                                        mill process, using natural
                                                                        gas, biomass, or biogas for
                                                                        process energy and drying
                                                                        no more than 50% of the
                                                                        distillers grains with
                                                                        solubles it markets
                                                                        annually.
D.............  Ethanol................  Corn starch.................  Wet mill process using                  6
                                                                        biomass or biogas for
                                                                        process energy.
E.............  Ethanol................  Starches from crop residue    Fermentation using natural              6
                                          and annual covercrops.        gas, biomass, or biogas for
                                                                        process energy.
F.............  Biodiesel, renewable     Soy bean oil; Oil from        One of the following: Trans-            4
                 diesel, jet fuel and     annual covercrops; Algal      Esterification
                 heating oil.             oil; Biogenic waste oils/     Hydrotreating Excluding
                                          fats/greases; Non-food        processes that co-process
                                          grade corn oil Camelina       renewable biomass and
                                          sativa oil.                   petroleum.
G.............  Biodiesel, heating oil.  Canola/Rapeseed oil.........  Trans-Esterification using              4
                                                                        natural gas or biomass for
                                                                        process energy.
H.............  Biodiesel, renewable     Soy bean oil; Oil from        One of the following: Trans-            5
                 diesel, jet fuel and     annual covercrops; Algal      Esterification
                 heating oil.             oil; Biogenic waste oils/     Hydrotreating Includes only
                                          fats/greases; Non-food        processes that co-process
                                          grade corn oil Camelina       renewable biomass and
                                          sativa oil.                   petroleum.
I.............  Naphtha, LPG...........  Camelina sativa oil.........  Hydrotreating...............            5
J.............  Ethanol................  Sugarcane...................  Fermentation................            5
K.............  Ethanol................  Cellulosic Biomass from crop  Any.........................            3
                                          residue, slash, pre-
                                          commercial thinnings and
                                          tree residue, annual
                                          covercrops, switchgrass,
                                          miscanthus, and energy
                                          cane; cellulosic components
                                          of separated yard waste;
                                          cellulosic components of
                                          separated food waste; and
                                          cellulosic components of
                                          separated MSW.
L.............  Cellulosic diesel, jet   Cellulosic Biomass from crop  Any.........................            7
                 fuel and heating oil.    residue, slash, pre-
                                          commercial thinnings and
                                          tree residue, annual
                                          covercrops, switchgrass,
                                          miscanthus, and energy
                                          cane; cellulosic components
                                          of separated yard waste;
                                          cellulosic components of
                                          separated food waste; and
                                          cellulosic components of
                                          separated MSW.
M.............  Renewable gasoline and   Cellulosic Biomass from crop  Catalytic Pyrolysis and                 3
                 renewable gasoline       residue, slash, pre-          Upgrading, Gasification and
                 blendstock.              commercial thinnings, tree    Upgrading, Thermo-Catalytic
                                          residue, annual cover         Hydrodeoxygenation and
                                          crops; cellulosic             Upgrading, Direct
                                          components of separated       Biological Conversion,
                                          yard waste; cellulosic        Biological Conversion and
                                          components of separated       Upgrading, all utilizing
                                          food waste; and cellulosic    natural gas, biogas, and/or
                                          components of separated MSW.  biomass as the only process
                                                                        energy sources Any process
                                                                        utilizing biogas and/or
                                                                        biomass as the only process
                                                                        energy sources.
N.............  Naphtha................  Cellulosic biomass from       Gasification and upgrading..            3
                                          switchgrass, miscanthus,
                                          and energy cane.
O.............  Butanol................  Corn starch.................  Fermentation; dry mill using            6
                                                                        natural gas, biomass, or
                                                                        biogas for process energy.

P.............  Ethanol, renewable       The non-cellulosic portions   Any.........................            5
                 diesel, jet fuel,        of separated food waste.
                 heating oil, and
                 naphtha.
Q.............  Biogas.................  Landfills, sewage waste       Any.........................            5
                                          treatment plants, manure
                                          digesters.
R.............  Ethanol................  Grain Sorghum...............  Dry mill process using                  6
                                                                        biogas from landfills,
                                                                        waste treatment plants, and/
                                                                        or waste digesters, and/or
                                                                        natural gas, for process
                                                                        energy.
S.............  Ethanol................  Grain Sorghum...............  Dry mill process, using only            5
                                                                        biogas from landfills,
                                                                        waste treatment plants, and/
                                                                        or waste digesters for
                                                                        process energy and for on-
                                                                        site production of all
                                                                        electricity used at the
                                                                        site other than up to 0.15
                                                                        kWh of electricity from the
                                                                        grid per gallon of ethanol
                                                                        produced, calculated on a
                                                                        per batch basis.
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-04929 Filed 3-4-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 124 (Thursday, June 29, 2023)]
[Notices]
[Pages 42080-42082]
[FR Doc No: 2023-13853]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2474]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; New Animal Drugs for
Minor Use and Minor Species

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by July 31, 2023.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0605. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

New Animal Drugs for Minor Use and Minor Species

OMB Control Number 0910-0605--Revision

    This information collection supports FDA regulations that implement
sections 572 and 573 of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360ccc-1 and 21 U.S.C. 360ccc-2) which establish an
index of legally marketed unapproved new animal drugs for minor species
and requirements for the designation of minor use or minor species new
animal drugs, respectively. Agency regulations are codified in part 516
(21 CFR part 516) and include recordkeeping and reporting requirements.
The purpose of these regulations is to encourage the development of
these new animal drugs, while still ensuring appropriate safeguards for
animal and human health. The general provisions in part 516, subpart A,
set forth its purpose, scope, and applicable definitions.
    Our regulations in part 516, subpart B, provide for designation
status for Minor Use and Minor Species (MUMS) drugs prior to their
approval or conditional approval. MUMS-drug designation makes the
sponsor eligible for incentives to support the approval or conditional
approval of the designated use and is completely optional for drug
sponsors. The regulations describe how to apply for designation, what
needs to be submitted, and other information pertaining to this option.
Sponsors of designated new animal drugs are required to demonstrate due
diligence toward approval or conditional approval through submission of
annual reports documenting their progress for each designated use. We
use this information to allow for determining eligibility for
designation and the associated incentives and benefits, including a 7-
year period of exclusive marketing rights, as provided by section 573
of the FD&C Act. It enables us to process requests for MUMS-drug
designation, requests to amend MUMS-drug designation, changes in
sponsorship, termination of MUMS-drug designation, requirements for
annual reports from sponsors, and provisions for insufficient
quantities of MUMS-designated drugs.
    Regulations in part 516, subpart C, are intended to make more
medications legally available to veterinarians and animal owners for
the treatment of minor animal species. In some cases, a minor species
drug is intended for use in species that are too rare or too varied to
be the subject of adequate and well-controlled studies in support of a
drug approval. In such cases, FDA may add the drug to the public index
listing of legally marketed unapproved new animal drugs for minor
species animals (Index), as provided for by section 572 of the FD&C
Act. Within limitations established by the statute, such indexing
provides a basis for legally marketing an unapproved new animal drug
intended for use in a minor species. Our regulations in part 516,
subpart C, specify, among other things, the criteria and procedures for
requesting eligibility for indexing and for requesting addition to the
Index, as well as the annual reporting requirements for holders of an
index listing. The administrative procedures and criteria for indexing
a new animal drug for use in a minor species, as well as modifications
and removal of a drug from the Index are also set forth. FDA uses the
information for the activities described above.
    In the Federal Register of August 1, 2022 (87 FR 46961), FDA
published a 60-day notice requesting public

comment on the information collection requirements related to
designation status for MUMS drugs. No comments were received. We are
revising the information collection to add the information collection
requirements associated with the index listing of legally marketed
unapproved new animal drugs for minor species, for efficiency of Agency
operations.
    Description of Respondents: The respondents to this information
collection are pharmaceutical companies that sponsor new animal drugs
for designation or requesters wishing to add a new animal drug to the
Index.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
    21 CFR section; activity         Number of     responses per   Total annual    per response     Total hours
                                    respondents     respondent     responses \2\      (hours)           \3\
----------------------------------------------------------------------------------------------------------------
                Designated New Animal Drugs for Minor Use and Minor Species, Part 516, Subpart B
----------------------------------------------------------------------------------------------------------------
516.20, 516.26, 516.27, 516.29,               26           ~2.65              69               4             276
 516.30, and 516.36; Reporting
 burden associated with drug
 designation requests and
 termination of designation.....
----------------------------------------------------------------------------------------------------------------
          Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, Part 516, Subpart C
----------------------------------------------------------------------------------------------------------------
516.119, 516.121, 516.123,                    30          ~10.33             310         ~16.954           5,256
 516.125, 516.141, 516.143,
 516.145; 516.161, 516.163, and
 516.165; Reporting burden
 associated with requests for
 index listing and modifying
 indexed drugs..................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           5,532
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Decimal rounded.
\3\ Rounded up.

    Burden we attribute to reporting activities is assumed to be
distributed among the individual elements and averaged among
respondents. Our estimate of the burden per disclosure (4 and 16.954
hours, respectively) reflect what we believe is the average burden
based on the reporting required by the information collection.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                 Number of
  21 CFR section, activity       Number of      records per    Total annual   Average burden per    Total hours
                               recordkeepers   recordkeeper       records        recordkeeping
----------------------------------------------------------------------------------------------------------------
                Designated New Animal Drugs for Minor Use and Minor Species, Part 516, Subpart B
----------------------------------------------------------------------------------------------------------------
One-time recordkeeping                   474               1             474  0.68 (~41 minutes)             323
 burden associated with                                                        \3\.
 reading and understanding
 the rule \2\.
----------------------------------------------------------------------------------------------------------------
          Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, Part 516, Subpart C
----------------------------------------------------------------------------------------------------------------
516.141 and 516.165;                      40               2              80  0.625 (37.5                     50
 recordkeeping associated                                                      minutes).
 with panel deliberations
 and the information
 pertinent to the safety and
 effectiveness from foreign
 sources.
                             -----------------------------------------------------------------------------------
    Total...................  ..............  ..............  ..............  ..................             373
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Direct Final Rule, ``Defining `Small Number of Animals' for Minor Use Determination; Periodic Reassessment''
  (September 15, 2022; 87 FR 56583). Preliminary Regulatory Impact Analysis (https://www.regulations.gov/document/FDA-2022-N-1128-0007).
\3\ Rounded up.

    Burden we attribute to recordkeeping activities for the indexing
provisions is assumed to be distributed among the individual elements
and averaged among respondents. Our estimate of the burden per record
(0.625 hours) reflects what we believe is the average burden based on
the recordkeeping required by the information collection.
    For efficiency of Agency operations, we are consolidating the
related information collection activities currently approved in OMB
control numbers 0910-0605 and 0910-0620 into a single collection
request. The burden estimates reflect our current experience with the
information collection and requests received by respondents over the
past 3 years. We also include burden that may be attributable to
rulemaking (RIN 0910-A146), which became effective on December 14,
2022. Although the rulemaking revised the definition of ``small number
of animals,'' for purposes of determining whether a particular intended
use of a drug in a major species qualifies as a minor use, we believe
only nominal adjustments in burden associated with designation status
for MUMS drugs may result, other than a one-time recordkeeping burden.
In addition, upon review of the previous information collection
submission related to

indexing, we include burden associated with recordkeeping to address a
data-entry error in the RISC/ORIA Combined Information System (ROCIS
system). Cumulatively, these changes and adjustments reflect an overall
increase of 5,905 hours and a corresponding increase of 864 responses,
annually, to the information collection.

    Dated: June 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-13853 Filed 6-28-23; 8:45 am]
BILLING CODE 4164-01-P


"Calamas, MaryAnne"<EMAIL_ADDRESS> 02/26/2008 02:36 PM

To

Alexander Cristofaro/DC/USEPA/US@EPA, Lydia Wegman/RTP/USEPA/US@EPA, Robert Meyers/DC/USEPA/US@EPA

cc

Subject

12866 mtng at OMB w/ NAM

OIRA just discovered that NAM is coming in tomorrow to meet with our Deputy Director, Steve McMillin re the ozone rule.  We apologize for the late notice.

The meeting is scheduled for:

Wednesday, February 27th

11:00 AM

Room 252 EEOB

Please let me know if you or someone from your staff would like to attend and I can clear you into the building.

Thank you!

Mary Anne Calamas

Office of Information and Regulatory Affairs

Office of Management and Budget

Executive Office of the President

(202) 395-4852

<EMAIL_ADDRESS>


[Federal Register Volume 84, Number 224 (Wednesday, November 20, 2019)]
[Proposed Rules]
[Pages 64035-64037]
[FR Doc No: 2019-25063]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[Docket No. EPA-R09-OAR-2019-0564; FRL-10002-24-Region 9]

Air Plan Approval; California; Mojave Desert Air Quality
Management District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve revisions to the Mojave Desert Air Quality Management District
(MDAQMD) portion of the California State Implementation Plan (SIP).
These revisions concern emissions of volatile organic compounds (VOCs)
from organic liquid and gasoline transfer and storage operations. We
are proposing to approve local rules to regulate these emission sources
under the Clean Air Act (CAA or the Act). We are taking comments on
this proposal and plan to follow with a final action.

DATES: Any comments must arrive by December 20, 2019.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2019-0564 at https://www.regulations.gov. For comments submitted at
Regulations.gov, follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or removed from
Regulations.gov. For either manner of submission, 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, please contact
the person identified in the FOR FURTHER INFORMATION CONTACT section.
For the full EPA public comment policy, information about CBI or
multimedia submissions, and general guidance on making effective
comments, please visit http://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Rebecca Newhouse, EPA Region IX, 75
Hawthorne St., San Francisco, CA 94105,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Table of Contents

I. The State's Submittal
    A. What rules did the State submit?
    B. Are there other versions of these rules?
    C. What is the purpose of the submitted rule revisions?
II. The EPA's Evaluation and Action
    A. How is the EPA evaluating the rules?
    B. Do the rules meet the evaluation criteria?
    C. EPA Recommendations To Further Improve the Rules
    D. Public Comment and Proposed Action
III. Incorporation by Reference
IV. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rules did the State submit?

    Table 1 lists the rules addressed by this proposal with the dates
that they were adopted by the local air agency and submitted by the
California Air Resources Board (CARB).

                                            TABLE 1--Submitted Rules
----------------------------------------------------------------------------------------------------------------
        Local agency                   Rule No.                 Rule title            Amended        Submitted
----------------------------------------------------------------------------------------------------------------
MDAQMD......................  461.......................  Gasoline Transfer and       01/22/2018      05/23/2018
                                                           Dispensing.
MDAQMD......................  462.......................  Organic Liquid Loading      01/22/2018      05/23/2018
MDAQMD......................  463.......................  Storage of Organic          01/22/2018      05/23/2018
                                                           Liquids.
----------------------------------------------------------------------------------------------------------------

    On November 23, 2018, the submittal of Rules 461, 462, and 463 for
MDAQMD was deemed by operation of law to meet the completeness criteria
in 40 CFR part 51 Appendix V, which must be met before formal EPA
review.

B. Are there other versions of these rules?

    The MDAQMD regulates portions of San Bernardino and Riverside
Counties. On July 1, 1994, a portion of Riverside County left the South
Coast Air Quality Management District (SCAQMD) and joined the MDAQMD.
The EPA-approved SIP for this portion of Riverside County remained the
same when the area changed districts. As a result, the Riverside County
portion of the MDAQMD SIP retained the SCAQMD rules in place at that
time.
    We approved earlier versions of MDAQMD Rules 461 and 462 into the
SIP on May 3, 1995 (60 FR 21702). These rules applied in both the San
Bernardino and Riverside County portions of the MDAQMD and replaced the
existing versions of Rules 461 and 462 in place in the District at that
time.
    On May 3, 1995 (60 FR 21702), we also approved a version of Rule
463 submitted by the San Bernardino County Air Pollution Control
District on November 2, 1992. This rule was only approved to apply in
the San Bernardino County portion of the District. In the Riverside
County portion of the MDAQMD, the EPA approved the June 1, 1984 version
of SCAQMD Rule 463 on January 15, 1987 (52 FR 1627). For a more
complete discussion of the SIP history of these rules, see the
technical support documents (TSDs).
    The MDAQMD adopted revisions to all three rules on January 22,
2018, and CARB submitted them to us on May 23, 2018. In its submission,
the District requested that in the San Bernardino County portion of the
District the newly-adopted rules replace the versions of Rules 461,
462, and 463, approved in 1995, and that in the Riverside County
portion of the District, the rules replace all versions of the rules
that are applicable in Riverside County.

C. What is the purpose of the submitted rule revisions?

    Emissions of VOCs contribute to the production of ground-level
ozone, smog and particulate matter, which harm human health and the
environment. Section 110(a) of the CAA requires states to submit
regulations that control VOC emissions. SIP-approved Rules 461, 462,
and 463 limit VOC emissions from organic liquid storage tanks and
during transfers at bulk terminals, bulk gasoline plants, and gasoline
dispensing

facilities. Major revisions to the SIP-approved versions of the rules
include requiring CARB-certification for vapor recovery systems,
requiring a minimum vapor recovery efficiency for gasoline transfers to
mobile fuelers, lowering the threshold for determining vapor leaks,
lowering the vapor pressure cut-off for stationary storage tanks,
adding an emissions limit for organic liquid transfers at bulk
terminals, adding backpressure requirements during organic liquid
transfer, and strengthening recordkeeping and inspection requirements,
among other changes. The EPA's TSDs have more information about these
rules.
    Additionally, on February 12, 2018 (83 FR 5921), the EPA partially
conditionally approved MDAQMD's reasonably available control technology
(RACT) demonstrations for the 1997 8-hr ozone National Ambient Air
Quality Standards (NAAQS) and the 2008 8-hr ozone NAAQS (also referred
to as the 2006 and 2015 RACT SIPs) with respect to Rules 461, 462, and
463, based on commitments from MDAQMD and CARB to adopt and submit
amendments to those rules to implement current RACT.\1\ These rules
were revised by the District and submitted to the EPA by CARB for
incorporation into the SIP to ensure continued compliance with the CAA
RACT requirement, and to fulfill commitments necessary for the EPA to
convert the partial conditional approval of the District's 2006 and
2015 RACT SIPs into a full approval for the VOC source categories
covered by Rules 461, 462, and 463.
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    \1\ Letter dated September 25, 2017, from Brad Poiriez, Air
Pollution Control Officer, MDAQMD, to Alexis Strauss, Acting
Regional Administrator, EPA, Region IX, and Richard Corey, Executive
Officer, CARB; and letter dated October 3, 2017, from Jon Taylor,
Acting Chief, Air Quality Planning and Science Division, CARB, to
Alexis Strauss, Acting Regional Administrator, EPA, Region IX.
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II. The EPA's Evaluation and Action

A. How is the EPA evaluating the rules?

    SIP rules must be enforceable (see CAA section 110(a)(2)), must not
interfere with applicable requirements concerning attainment and
reasonable further progress or other CAA requirements (see CAA section
110(l)), and must not modify certain SIP control requirements in
nonattainment areas without ensuring equivalent or greater emissions
reductions (see CAA section 193).
    Generally, SIP rules must require RACT for each category of sources
covered by a Control Techniques Guidelines (CTG) document as well as
each major source of VOCs in ozone nonattainment areas classified as
Moderate or above (see CAA section 182(b)(2)). The MDAQMD regulates an
ozone nonattainment area classified as Severe for the 1997, 2008, and
2015 8-hour ozone NAAQS (40 CFR 81.305). Therefore, these rules must
implement RACT.
    Guidance and policy documents that we used to evaluate
enforceability, revision/relaxation and rule stringency requirements
for the applicable criteria pollutants include the following:

    1. ``State Implementation Plans; General Preamble for the
Implementation of Title I of the Clean Air Act Amendments of 1990,''
57 FR 13498 (April 16, 1992); 57 FR 18070 (April 28, 1992).
    2. ``Issues Relating to VOC Regulation Cutpoints, Deficiencies,
and Deviations,'' EPA, May 25, 1988 (the Bluebook, revised January
11, 1990).
    3. ``Guidance Document for Correcting Common VOC & Other Rule
Deficiencies,'' EPA Region 9, August 21, 2001 (the Little Bluebook).
    4. ``Control of Volatile Organic Emissions from Storage of
Petroleum Liquids in Fixed-Roof Tanks,'' EPA-450/2-77-036, December
1977.
    5. ``Control of Volatile Organic Emissions from Petroleum Liquid
Storage in External Floating Roof Tanks,'' EPA-450/2-78-047,
December 1978.
    6. ``Control of Volatile Organic Emissions from Bulk Gasoline
Plants,'' EPA-450/2-77-035, December 1977.
    7. ``Control of Hydrocarbons from Tank Truck Gasoline Loading
Terminals,'' EPA-450/2-77-026, October 1977.
    8. ``Control of Volatile Organic Compound Leaks from Gasoline
Tank Trucks and Vapor Collection Systems,'' EPA-450/2-78-051,
December 1978.
    9. ``Design Criteria for Stage I Vapor Control Systems-Gasoline
Service Stations,'' EPA-450/R-75-102, November 1975.
    10. ``Alternative Control Techniques Document: Volatile Organic
Liquid Storage in Floating and Fixed Roof Tanks,'' EPA-453/R-94-001,
January 1994.

B. Do the rules meet the evaluation criteria?

    These rules are consistent with CAA requirements and relevant
guidance regarding enforceability, RACT, and SIP revisions, and fulfill
the District's commitment to revise the rules to meet current RACT. The
TSDs have more information on our evaluation.

C. EPA Recommendations To Further Improve the Rules

    The TSDs describe additional rule revisions that we recommend for
the next time the local agency modifies the rules.

D. Public Comment and Proposed Action

    As authorized in section 110(k)(3) of the Act, the EPA proposes to
fully approve the submitted rules because they fulfill all relevant
requirements. In addition, we propose to convert the partial
conditional approval of the District's RACT SIPs with respect to Rules
461, 462, and 463, as found in 40 CFR 52.248(d), to a full approval. We
will accept comments from the public on this proposal until December
20, 2019. If we take final action to approve the submitted rules, our
final action will incorporate these rules into the federally
enforceable SIP.

III. Incorporation by Reference

    In this document, the EPA is proposing to include in a final EPA
rule regulatory text that includes incorporation by reference. In
accordance with requirements of 1 CFR 51.5, the EPA is proposing to
incorporate by reference the MDAQMD rules described in Table 1 of this
preamble. The EPA has made, and will continue to make, these materials
available through www.regulations.gov and at the EPA Region IX Office
(please contact the person identified in the FOR FURTHER INFORMATION
CONTACT section of this preamble for more information).

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this proposed action merely proposes to approve state law
as meeting federal requirements and does not impose additional
requirements beyond those imposed by state law. For that reason, this
proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely

affect small governments, as described in the Unfunded Mandates Reform
Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide the EPA with the discretionary authority
to address disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Reporting and
recordkeeping requirements, Volatile organic compounds.

    Authority:  42 U.S.C. 7401 et seq.

    Dated: November 4, 2019.
Deborah Jordan,
Acting Regional Administrator, Region IX.
[FR Doc. 2019-25063 Filed 11-19-19; 8:45 am]
 BILLING CODE 6560-50-P