[Federal Register: January 25, 2008 (Volume 73, Number 17)]
[Proposed Rules]
[Page 4502-4503]
[DOCID:fr25ja08-20]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 70

[EPA-R05-OAR-2007-1198; FRL-8521-4]

State Operating Permits Program; Ohio; Revision to the Acid Rain
Regulations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA proposes to approve into the Ohio operating permits
program revisions submitted by the State of Ohio for the purpose of
amending the Acid Rain Permits and Compliance portion of the program.
The changes made to OAC 3745-103, which comprises the revisions,
include rules for phase II acid rain permits and new information on
items incorporated by reference.

DATES: Comments must be received on or before February 25, 2008.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2007-1198, by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: Pamela Blakley, Chief, Air Permits Section, Air Programs
Branch (AR 18J), U.S. Environmental Protection Agency, 77 West Jackson
Boulevard, Chicago, Illinois 60604.
    5. Hand Delivery: At the previously listed EPA Region 5 address.
Such deliveries are only accepted during the Regional Office normal
hours of operation, and special arrangements should be made for
deliveries of boxed information. The Regional Office official hours of
business are Monday through Friday, 8:30 a.m. to 4:30 p.m. excluding
Federal holidays.
    Please see the direct final rule which is located in the Rules
section of this Federal Register for detailed instructions on how to
submit comments.

FOR FURTHER INFORMATION CONTACT: Richard Angelbeck, Environmental
Scientist, Air Permits Section, Air Programs Branch (AR-18J), U.S.
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Final Rules section of this Federal
Register, EPA is approving the State's operating permits program
revision submittal as a direct final rule without prior proposal,
because the Agency views this as a noncontroversial submittal and
anticipates no adverse comments. A detailed rationale for the approval
is set forth in the direct final rule. If no adverse comments are
received in response to this action, no further activity is
contemplated. If EPA receives adverse comments, the direct final rule
will be withdrawn and all public comments received will be addressed in
a subsequent final rule based on this proposed rule. EPA will not
institute a second comment period. Any parties interested in commenting
on this action should do so at this time. Please note that if EPA
receives adverse comment on an amendment, paragraph, or section of this
rule, and if that provision may be severed from the remainder of the
rule, EPA may adopt as final those provisions of the rule that are not
the subject of an adverse comment. For additional information, see the
direct final rule which is located in the Rules section of this Federal
Register.

    Dated: January 15, 2008.
Margaret Guerriero,
Acting Regional Administrator, Region 5.
[FR Doc. E8-1319 Filed 1-24-08; 8:45 am]

BILLING CODE 6560-50-P


Point Source Category,'' EPA-821-R-11-004. See Sec.  435.11(ee) and
(uu).
    \9\ As determined before drilling fluids are shipped offshore by
the GC/MS compliance assurance method (EPA Method 1655), and as
determined prior to discharge by the RPE method (EPA Method 1670)
applied to drilling fluid removed from drill cuttings. If the
operator wishes to confirm the results of the RPE method (EPA Method
1670), the operator may use the GC/MS compliance assurance method
(EPA Method 1655). Results from the GC/MS compliance assurance
method (EPA Method 1655) shall supersede the results of the RPE
method (EPA Method 1670). EPA Method 1655 and 1670 are published as
appendices to Subpart A of this part and in ``Analytic Methods for
the Oil and Gas Extraction Point Source Category,'' EPA-821-R-11-
004. See Sec.  435.11(uu).
    \10\ Maximum permissible retention of non-aqueous drilling fluid
(NAF) base fluid on wet drill cuttings averaged over drilling
intervals using NAFs as determined by EPA Method 1674, which is
published as an appendix to Subpart A of this part and in ``Analytic
Methods for the Oil and Gas Extraction Point Source Category,'' EPA-
821-R-11-004. See Sec.  435.11(uu). This limitation is applicable
for NAF base fluids that meet the base fluid sediment toxicity ratio
(Footnote 6), biodegradation rate ratio (Footnote 7), PAH, mercury,
and cadmium stock limitations (C16-C18
internal olefin) defined above in this table.
    \11\ Maximum permissible retention of non-aqueous drilling fluid
(NAF) base fluid on wet drill cuttings average over drilling
intervals using NAFs as determined by EPA Method 1674, which is
published as an appendix to Subpart A of this part and in ``Analytic
Methods for the Oil and Gas Extraction Point Source Category,'' EPA-
821-R-11-004. See Sec.  435.11(uu). This limitation is applicable
for NAF base fluids that meet the ester base fluid sediment toxicity
ratio and ester biodegradation rate ratio stock limitations defined
as:
    (a) ester base fluid sediment toxicity ratio = 10-day
LC50 of C12-C14 ester or
C8 ester/10-day LC50 of stock base fluid as
determined by EPA Method 1644: ``Method for Conducting a Sediment
Toxicity Test with Leptocheirus plumulosus and Non-Aqueous Drilling
Fluids or Synthetic-Based Drilling Muds'' after sediment preparation
procedures specified in EPA Method 1646, which are published as
appendices to Subpart A of this part and in ``Analytic Methods for
the Oil and Gas Extraction Point Source Category,'' EPA-821-R-11-
004. See Sec.  435.11(ee) and (uu);
    (b) ester biodegradation rate ratio = Cumulative headspace gas
production (ml) of C12-C14 ester or
C8 ester/Cumulative headspace gas production (ml) of
stock base fluid, both at 275 days as determined by EPA Method 1647,
which is published as an appendix to Subpart A of this part and in
``Analytic Methods for the Oil and Gas Extraction Point Source
Category,'' EPA-821-R-11-004. See Sec.  435.11(e) and (uu); and (c)
PAH mass ratio (Footnote 5), mercury, and cadmium stock limitations
(C16-C18 internal olefin) defined above in
this table.

0
22. The heading of Appendix 1 to Subpart A of Part 435 is revised to
read as follows:

Appendix 1 to Subpart A of Part 435-- Static Sheen Test (EPA Method
1617)

* * * * *

0
23. Appendix 2 to Subpart A of Part 435 is amended as follows:
0
a. Revise the appendix heading.
0
b. Remove the fourth sentence from Section II.C.6.
0
c. Revise Section III.A.1.
0
d. Revise Section III.E.2.
    The revisions read as follows:

Appendix 2 to Subpart A of Part 435--Drilling Fluids Toxicity Test (EPA
Method 1619)

* * * * *
III-A. * * *

    (1) Each definitive test consists of 18 test containers: 3
replicates of a control and 5 SPP dilutions. Test containers should
be Pyrex or equivalent glass. For definitive tests, 5 SPP dilutions
with 3 replicates of at least 500 ml each are required. Twenty
mysids per replicate, 360 per definitive test are required.
* * * * *
III-E. * * *
    (2) Establish the definitive test concentrations based on
results of a range finding test or based on prior experience and
knowledge of the mud system.
* * * * *

0
24. The heading of Appendix 3 to Subpart A of Part 435 is amended to
read as follows:

Appendix 3 to Subpart A of Part 435--Procedure for Mixing Base Fluids
With Sediments (EPA Method 1646)

* * * * *

0
25. Appendix 4 to Subpart A of Part 435 is revised to read as follows:

Appendix 4 to Subpart A of Part 435-- Protocol for the Determination of
Degradation of Non-Aqueous Base Fluids in a Marine Closed Bottle
Biodegradation Test System: Modified ISO 11734:1995 (EPA Method 1647)

1.0. Summary of EPA Method 1647

    a. This method determines the anaerobic degradation potential of
mineral oils, paraffin oils and non-aqueous fluids (NAF) in
sediments. These substrates are base fluids for formulating offshore
drilling fluids. The test evaluates base fluid biodegradation rates
by monitoring gas production due to microbial degradation of the
test fluid in natural marine sediment.
    b. The test procedure places a mixture of marine/estuarine
sediment, test substrate (hydrocarbon or controls) and seawater into
clean 120 mL (150 mL actual volume) Wheaton serum bottles. The test
is run using four replicate serum bottles containing 2,000 mg
carbon/kg dry weight concentration of test substrate in sediment.
The use of resazurin dye solution (1 ppm) evaluates the anaerobic
(redox) condition of the bottles (dye is blue when oxygen is
present, reddish in low oxygen conditions and colorless if oxygen
free). After capping the bottles, a nitrogen sparge removes air in
the headspace before incubation begins. During the incubation
period, the sample should be kept at a constant temperature of 29
 1[deg]C. Gas production and composition is measured
approximately every two weeks. The samples need to be brought to
ambient temperature before making the measurements. Measure gas
production using a pressure gauge. Barometric pressure is measured
at the time of testing to make necessary volume adjustments.
    c. ISO 11734:1995 specifies that total gas is the standard
measure of biodegradation. While modifying this test for evaluating
biodegradation of NAFs, methane was also monitored and found to be
an acceptable method of evaluating biodegradation. Section 7
contains the procedures used to follow biodegradation by methane
production. Measurement of either total gas or methane production is
permitted. If methane is followed, determine the composition of the
gas by using gas chromatography (GC) analysis at each sampling. At
the end of the test when gas production stops, or at around 275
days, an analysis of sediment for substrate content is possible.
Common methods which have been successfully used for analyzing NAFs
from sediments are listed in Section 8.

2.0 System Requirements

    This environmental test system has three phases, spiked
sediment, overlying seawater, and a gas headspace. The sediment/test
compound mixture is combined with synthetic sea water and
transferred into 120-mL serum bottles. The total volume of sediment/
sea water mixture in the bottles is 75 mL. The volume of the
sediment layer will be approximately 50 mL, but the exact volume of
the sediment will depend on sediment characteristics (wet:dry ratio
and density). The amount of synthetic sea water will be calculated
to bring the total volume in the bottles to 75 mL. The test systems
are maintained at a temperature of 29  1[deg]C during
incubation. The test systems are brought to ambient temperatures
prior to measuring pressure or gas volume.

2.1 Sample Requirements

    a. The concentration of base fluids are at least 2,000 mg carbon
test material/kg dry sediment. Carbon concentration is determined by
theoretical composition based on the chemical formula or by chemical
analysis by ASTM D5291-96. Sediments with positive, intermediate and
negative control substances as well as a C16-
C18 internal olefin type base fluid will be run in
conjunction with test materials under the same conditions. The
positive control is ethyl oleate (CAS 111-62-6), the intermediate
control is 1-hexadecene (CAS 629-73-2), and the negative control is
squalane (CAS 111-01-3). Controls must be of analytical grade or

the highest grade available. Each test control concentration should
be prepared according to the mixing procedure described in Section
3.1.
    b. Product names will be used for examples or clarification in
the following text. Any use of trade or product names in this
publication is for descriptive use only, and does not constitute
endorsement by EPA or the authors.

2.2. Seawater Requirements

    Synthetic seawater at a salinity of 25  1 ppt should
be used for the test. The synthetic seawater should be prepared by
mixing a commercially available artificial seawater mix, into high
purity distilled or de-ionized water. The seawater should be aerated
and allowed to age for approximately one month prior to use.

2.3. Sediment Requirements

    a. The dilution sediment must be from a natural estuarine or
marine environment and be free of the compounds of interest. The
collection location, date and time will be documented and reported.
The sediment is prepared by press-sieving through a 2,000-micron
mesh sieve to remove large debris, then press-sieving through a 500-
micron sieve to remove indigenous organisms that may confound test
results. The water content of the sediment should be less than 60%
(w/w) or a wet to dry ratio of 2.5. The sediment should have a
minimum organic matter content of 3% (w/w) as determined by ASTM
D2974-07a (Method A and D and calculate organic matter as in Section
8.3 of method ASTM D2974-07a).
    b. To reduce the osmotic shock to the microorganisms in the
sediment the salinity of the sediment's pore water should be between
20-30 ppt. Sediment should be used for testing as soon as possible
after field collection. If required, sediment can be stored in the
dark at 4 [deg]C with 3-6 inches of overlying water in a sealed
container for a maximum period of 2 months prior to use.

3.0 Test Set Up

    The test is set up by first mixing the test or control
substrates into the sediment inoculum, then mixing in seawater to
make a pourable slurry. The slurry is then poured into serum
bottles, which are then flushed with nitrogen and sealed.

3.1. Mixing Procedure

    Because base fluids are strongly hydrophobic and do not readily
mix with sediments, care must be taken to ensure base fluids are
thoroughly homogenized within the sediment. All concentrations are
weight-to-weight comparisons (mg of base fluid to kg of dry control
sediment). Sediment and base fluid mixing will be accomplished by
using the following method.
    3.1.1. Determine the wet to dry weight ratio for the control
sediment by weighing approximately 10 sub-samples of approximately 1
g each of the screened and homogenized wet sediment into tared
aluminum weigh pans. Dry sediment at 105 [deg]C for 18-24 h. Remove
the dried sediments and cool in a desiccator. Repeat the drying,
cooling, and weighing cycle until a constant weight is achieved
(within 4% of previous weight). Re-weigh the samples to determine
the dry weight. Calculate the mean wet and dry weights of the 10 sub
samples and determine the wet/dry ratio by dividing the mean wet
weight by the mean dry weight using Equation 5-1. This is required
to determine the weight of wet sediment needed to prepare the test
samples.
[GRAPHIC] [TIFF OMITTED] TR18MY12.008

    3.1.2. Determine the density (g/ml) of the wet sediment. This
will be used to determine total volume of wet sediment needed for
the various test treatments. One method is to tare a 5 ml graduated
cylinder and add about 5 ml of homogenized sediment. Carefully
record the volume then weigh this volume of sediment. Repeat this a
total of three times. To determine the wet sediment density, divide
the weight by volume per the following formula:
[GRAPHIC] [TIFF OMITTED] TR18MY12.009

    3.1.3. Determine the amount of base fluid to be spiked into wet
sediment in order to obtain the desired initial base fluid
concentration of 2,000 mg carbon/kg dry weight. An amount of wet
sediment that is the equivalent of 30 g of dry sediment will be
added to each bottle. A typical procedure is to prepare enough
sediment for 8 serum bottles (3 bottles to be sacrificed at the
start of the test, 4 bottles incubated for headspace analysis, and
enough extra sediment for 2 extra bottles). Extra sediment is needed
because some of the sediment will remain coated onto the mixing bowl
and utensils. Experience with this test may indicate that preparing
larger volumes of spiked sediment is a useful practice, then the
following calculations should be adjusted accordingly.
    a. Determine the total weight of dry sediment needed to add 30 g
dry sediment to 8 bottles. If more bottles are used then the
calculations should be modified accordingly. For example:
[GRAPHIC] [TIFF OMITTED] TR18MY12.010

    b. Determine the weight of base fluid, in terms of carbon,
needed to obtain a final base fluid concentration of 2,000 mg
carbon/kg dry weight. For example:
[GRAPHIC] [TIFF OMITTED] TR18MY12.011

    c. i. Convert from mg of carbon to mg of base fluid. This
calculation will depend on the % fraction of carbon present in the
molecular structure of each base fluid. For the control fluids,
ethyl oleate is composed of 77.3% carbon, hexadecene is composed of
85.7% carbon, and squalane is composed of 85.3% carbon. The carbon
fraction of each base fluid should be supplied by the manufacturer
or determined before use. ASTM D5291-96 or equivalent will be used
to determine composition of fluid.
    ii. To calculate the amount of base fluid to add to the
sediment, divide the amount of carbon (480 mg) by the percent
fraction of carbon in the fluid.
    iii. For example, the amount of ethyl oleate added to 240 g dry
weight sediment can be calculated from the following equation:

[GRAPHIC] [TIFF OMITTED] TR18MY12.012

    iv. Therefore, add 621 mg of ethyl oleate to 240 g dry weight
sediment for a final concentration of 2,000 mg carbon/kg sediment
dry weight.
    3.1.4. Mix the calculated amount of base fluid with the
appropriate weight of wet sediment.
    a. Use the wet:dry ratio to convert from g sediment dry weight
to g sediment wet weight, as follows:
[GRAPHIC] [TIFF OMITTED] TR18MY12.013

    b. i. Weigh the appropriate amount of base fluid (calculated in
Section 3.1.3.c) into stainless mixing bowls, tare the vessel
weight, then add the wet sediment calculated in Equation 5, and mix
with a high shear dispersing impeller for 9 minutes.
    ii. The sediment is now mixed with synthetic sea water to form a
slurry that will be transferred into the bottles.
    3.2. Creating Seawater/Sediment Slurry
    Given that the total volume of sediment/sea water slurry in each
bottle is to be 75 mL, determine the volume of sea water to add to
the wet sediment.
    3.2.1. If each bottle is to contain 30 g dry sediment, calculate
the weight, and then the volume, of wet sediment to be added to each
bottle.
[GRAPHIC] [TIFF OMITTED] TR18MY12.014

    3.2.4. Convert the wet sediment weight from Equation 6 into a
volume using the sediment density.
[GRAPHIC] [TIFF OMITTED] TR18MY12.016

    3.2.5. Determine the amount of sea water to mix with the wet
sediment.
[GRAPHIC] [TIFF OMITTED] TR18MY12.017

    Mix sea water thoroughly with wet sediment to form a sediment/
sea water slurry.
    3.3. Bottling the Sediment Seawater Slurry
    The total volume of sediment/sea water slurry in each bottle is
to be 75 mL. Convert the volume (mL) of sediment/sea water slurry
into a weight (g) using the density of the sediment and the
seawater.

[GRAPHIC] [TIFF OMITTED] TR18MY12.018

    This should provide each bottle with 30 g dry sediment in a
total volume of 75 mL.
    3.3.4. Putting the sediment:seawater slurry in the serum
bottles.
    a. Note: The slurry will need to be constantly stirred to keep
the sediment suspended.
    b. Place a tared serum bottle on a balance and add the
appropriate amount of slurry to the bottle using a funnel. Once the
required slurry is in the bottle remove the funnel, add 2-3 drops
(25 [mu]L) of a 1 gram/L resazurin dye stock solution. Cap the
bottle with a butyl rubber stopper (Bellco Glass, Part
2048-11800) and crimp with an aluminum seal (Bellco Glass
Part 2048-11020).
    c. Using a plastic tube with a (23-gauge, 1-inch long) needle
attached to one side and a nitrogen source to the other, puncture
the serum cap with the needle. Puncture the serum cap again with a
second needle to sparge the bottle's headspace of residual air for
two minutes. The nitrogen should be flowing at no more than 100 mL/
min to encourage gentle displacement of oxygenated air with
nitrogen. Faster nitrogen flow rates would cause mixing and complete
oxygen removal would take much longer. Remove the nitrogen needle
first to avoid any initial pressure problems. The second (vent)
needle should be removed within 30 seconds of removing the nitrogen
needle.
    d. Triplicate blank test systems are prepared, with similar
quantities of sediment and seawater without any base fluid. Incubate
in the dark at a constant temperature of 29  1 [deg]C.
    e. Record the test temperature. The test duration is dependent
on base fluid performance, but at a maximum should be no more than
275 days. Stop the test after all base fluids have achieved a
plateau of gas production. At termination, base fluid concentrations
can be verified in the terminated samples by extraction and GC
analysis according to Section 8.

4.0. Concentration Verification Chemical Analyses

    a. Because of the difficulty of homogeneously mixing base fluid
with sediment, it is important to demonstrate that the base fluid is
evenly mixed within the sediment sea water slurry that was added to
each bottle. Of the seven serum bottles set up for each test or
control condition, three are randomly selected for concentration
verification analyses. These should be immediately placed at 4
[deg]C and a sample of sediment from each bottle should be analyzed
for base fluid content as soon as possible. The coefficient of
variation (CV) for the replicate samples must be less than 20%. The
results should show recovery of at least 70% of the spiked base
fluid. Use an appropriate analytical procedure described in Section
8 to perform the extractions and analyses. If any set of sediments
fail the criteria for concentration verification, then the
corrective action for that set of sediments is also outlined in
Section 8.
    b. The nominal concentrations and the measured concentrations
from the three bottles selected for concentration verification
should be reported for the initial test concentrations. The
coefficient of variation (CV) for the replicate samples must be less
than 20%. If base fluid content results are not within the 20% CV
limit, the test must be stopped and restarted with adequately mixed
sediment.

5.0. Gas Monitoring Procedures

    Biodegradation is measured by total gas as specified in ISO
11734:1995. Methane production can also be tracked and is described
in Section 7.

5.1. Total Gas Monitoring Procedures

    Bottles should be brought to room temperature before readings
are taken. a. The bottles are observed to confirm that the resazurin
has not oxidized to pink or blue. Total gas production in the
culture bottles should be measured using a pressure transducer (one
source is Biotech International). The pressure readings from test
and control cultures are evaluated against a calibration curve
created by analyzing the pressure created by known additions of gas
to bottles established identically to the culture bottles. Bottles
used for the standard curve contain 75 mL of water, and are sealed
with the same rubber septa and crimp cap seals used for the bottles
containing sediment. After the bottles used in the standard curve
have been sealed, a syringe needle inserted through the septa is
used to equilibrate the pressure inside the bottles to the outside
atmosphere. The syringe needle is removed and known volumes of air
are injected into the headspace of the bottles. Pressure readings
provide a standard curve relating the volume of gas injected into
the bottles and headspace pressure. No less than three points may be
used to generate the standard curve. A typical standard curve may
use 0, 1, 5, 10, 20 and 40 mL of gas added to the standard curve
bottles.
    b. The room temperature and barometric pressure (to two digits)
should be recorded at the time of sampling. One option for the
barometer is Fisher Part 02-400 or 02-401. Gas production
by the sediment is expressed in terms of the volume (mL) of gas at
standard temperature (0 [deg]C = 273 [deg]K) and pressure (1 atm =
30 inches of Hg) using Eq. 16.
[GRAPHIC] [TIFF OMITTED] TR18MY12.020

Where:

V2 = Volume of gas production at standard temperature and
pressure
P1 = Barometric pressure on day of sampling (inches of
Hg)
V1 = Volume of gas measured on day of sampling (mL)
T2 = Standard temperature = 273 [deg]K
T1 = Temperature on day of sampling ([deg]C + 273 =
[deg]K)
P2 = Standard pressure = 30 inches Hg

    c. An estimate can be made of the total volume of anaerobic gas
that will be produced in the bottles. The gas production measured
for each base fluid can be expressed as a percent of predicted total
anaerobic gas production.
    5.1.1. Calculate the total amount of carbon in the form of the
base fluid present in each bottle.
    a. Each bottle is to contain 30 g dry weight sediment. The base
fluid concentration is 2,000 mg carbon/kg dry weight sediment.
Therefore:

[GRAPHIC] [TIFF OMITTED] TR18MY12.021

    5.1.2. Theory states that anaerobic microorganisms will convert
1 mole of carbon substrate into 1 mole of total anaerobic gas
production.
    a. Calculate the number of moles of carbon in each bottle.
    b. The molecular weight of carbon is 12 (i.e., 1 mole of carbon
= 12 g). Therefore, the number of moles of carbon in each bottle can
be calculated.
[GRAPHIC] [TIFF OMITTED] TR18MY12.022

    5.1.3. Calculate the predicted volume of anaerobic gas.
    One mole of gas equals 22.4 L (at standard temperature and
pressure), therefore,
[GRAPHIC] [TIFF OMITTED] TR18MY12.023

5.2. Gas Venting

    a. If the pressure in the serum bottle is too great for the
pressure transducer or syringe, some of the excess gas must be
wasted. The best method to do this is to vent the excess gas right
after measurement. To do this, remove the barrel from a 10-mL
syringe and fill it \1/3\ full with water. This is then inserted
into the bottle through the stopper using a small diameter (high
gauge) needle. The excess pressure is allowed to vent through the
water until the bubbles stop. This allows equalization of the
pressure inside the bottle to atmospheric without introducing
oxygen. The amount of gas vented (which is equal to the volume
determined that day) must be kept track of each time the bottles are
vented. A simple way to do this in a spreadsheet format is to have a
separate column in which cumulative vented gas is tabulated. Each
time the volume of gas in the cultures is analyzed, the total gas
produced is equal to the gas in the culture at that time plus the
total of the vented gas.
    b. To keep track of the methane lost in the venting procedure,
multiply the amount of gas vented each time by the corrected %
methane determined on that day. The answer gives the volume of
methane wasted. This must be added into the cumulative totals
similarly to the total gas additions.

6.0. Test Acceptability and Interpretation

6.1. Test Acceptability

    At day 275 or when gas production has plateaued, whichever is
first, the controls are evaluated to confirm that the test has been
performed appropriately. In order for this modification of the
closed bottle biodegradation test to be considered acceptable, all
the controls must meet the biodegradation levels indicated in Table
1. The intermediate control hexadecene must produce at least 30% of
the theoretical gas production. This level may be reexamined after
two years and more data has been generated.

                                      Table 1--Test Acceptability Criteria
----------------------------------------------------------------------------------------------------------------
           Concentration                      Percent biodegradability as a function of gas measurement
----------------------------------------------------------------------------------------------------------------
                                                                Squalane negative      Hexadecene intermediate
                                        Positive control             control                   control
----------------------------------------------------------------------------------------------------------------
2,000 mg carbon/kg.................  >=60% theoretical.....  <=5% theoretical......  >=30% theoretical.
----------------------------------------------------------------------------------------------------------------

6.2 Interpretation

    a. In order for a fluid to pass the closed bottle test, the
biodegradation of the base fluid as indicated by the total amount of
total gas (or methane) generated once gas production has plateaued
(or at the end of 275 days, which ever is first) must be greater
than or equal to the volume of gas (or methane) produced by the
reference standard (internal elefin or ester).
    b. The method for evaluating the data to determine whether a
fluid has passed the biodegradation test must use the equations:
[GRAPHIC] [TIFF OMITTED] TR18MY12.024

Where:

NAF = Stock base fluid being tested for compliance
Reference fluid = C16-C18 internal olefin or
C12 -C14 or C8 ester reference
fluid

7.0. Methane Measurement

7.1. Methane Monitoring Procedures

    a. The use of total gas production alone may result in an
underestimation of the actual metabolism occurring since
CO2 is slightly soluble in water. An acceptable
alternative method is to monitor methane production and total gas
production. This is easily done using GC analysis. A direct
injection of headspace gases can be made into a GC using almost any
packed or capillary column with an FID detector. Unless volatile
fuels or solvents are present in the test material or the inocula,
the only component of the headspace gas that can be detected using
an FID detector is methane. The percent methane in the headspace gas
is determined by comparing the response of the sample injections to
the response from injections of known percent methane standards. The
percent methane is corrected for water vapor saturation using Eq. 21
and then converted to a volume of dry methane using Eq. 22.

[GRAPHIC] [TIFF OMITTED] TR18MY12.025

Where:

D = The density of water vapor at saturation (g/m\3\, can be found
in CRC Handbook of Chemistry and Physics) for the temperature of
sampling.
[GRAPHIC] [TIFF OMITTED] TR18MY12.026

Where:

VCH4 = Volume of methane in the bottle
S = Volume of excess gas production (measured with a pressure
transducer)
V = Volume of the headspace in the culture bottle (total volume--
liquid phase)
P = Barometric pressure (mm Hg, measured with barometer)
T = Temperature ([deg]C)
Pw = Vapor pressure of water at T (mm Hg, can be found in
CRC Handbook of Chemistry and Physics)
CH4 = % methane in headspace gas (after correction for
water vapor)

    b. The total volume of serum bottles sold as 125 mL bottles
(Wheaton) is 154.8 mL.
    c. The volumes of methane produced are then compared to the
volumes of methane in the controls to determine if a significant
inhibition of methane production or a significant increase of
methane production has been observed. Effective statistical analyses
are important, as variability in the results is common due to the
heterogeneity of the inoculum's source. It is also common to observe
that the timing of the initiation of culture activity is not equal
in all of the cultures. Expect a great variability over the period
when the cultures are active, some replicates will start sooner than
others, but all of the replicates should eventually reach similar
levels of base fluid degradation and methane production.

7.2. Expected Methane Production Calculations

    a. The amount of methane expected can be calculated using the
equation of Symons and Buswell (Eq. 23). In the case of complete
mineralization, all of the carbon will appear as wither
CO2 or CH4, thus the total moles of gas
produced will be equal to the total moles of carbon in the parent
molecule. The use of the Buswell equation allows you to calculate
the effects the redox potential will have on the distribution of the
products in methanogenic cultures. More reduced electron donors will
allow the production of more methane, while more oxidized electron
donors will cause a production of more carbon dioxide.
[GRAPHIC] [TIFF OMITTED] TR18MY12.027

    b. An example calculation of the expected methane volume in a
culture fed 2,000 mg/kg hexadecene is as follows. The application of
Symons and Buswell's equation reveals that hexadecene
(C16H32) will yield 4 moles of CO2
and 12 moles of CH4. Assuming 30 g of dry sediment are
added to the bottles with 2,334 mg hexadecene/kg dry sediment (i.e.,
equivalent to 2,000 mg carbon/kg dry sediment) the calculation is as
follows.
[GRAPHIC] [TIFF OMITTED] TR18MY12.028

    c. By subtracting the average amount of methane in control
bottles from the test bottles and then dividing by the expected
volume an evaluation of the completion of the process may be
conducted.

8.0. Concentration Verification Analysis

    The Concentration Verification analysis is required at the
beginning of the test to ensure homogeneity and confirm that the
required amount of fluid was delivered to the sediments at the start
of the test.
    8.1. Three samples per fluid need to be analyzed and achieve
<=20% Coefficient of Variability and an average of >=70% to <=120%
of fluid delivered to sediment.
    8.2. If a third party performs the analysis, then the laboratory
should be capable of delivering the homogeneity data within seven
days, in order to identify any samples that do not meet the
homogeneity requirement as quickly as possible.
    8.3. If one sediment/fluid set, out a multiple set batch of
samples, fails these criteria, then that one set of samples must be
discarded and a fresh set of spiked sediment prepared, started, and
analyzed to ensure homogeneity. The same stock sediment is used to
prepare the replacement set(s). The remaining sets do not need to be
re-mixed or restarted.
    8.4. The re-mixed set(s) will need to be run the additional days
as appropriate to ensure that the total number of days is the same
for all sets of bottles, even though the specific days are not
aligned.
    8.5. Re-mixing of bottle sets can be performed multiple times as
a result of a failure of the analytical criteria, until the holding
time for the stock sediment has expired (60 days). If the problem
set(s) has not fallen within the acceptable analytical criteria by
then, it must not be part of the batch of bottles run. If the
problem batch is one of the controls, and those controls were not
successfully prepared when the sediment holding time expired, then
the entire test must be restarted.

9.0 Program Quality Assurance and Quality Control

9.1 Calibration

    9.1.1. All equipment/instrumentation will be calibrated in
accordance with the test method or the manufacturer's instructions
and may be scheduled or triggered.
    9.1.2. Where possible, standards used in calibration will be
traceable to a nationally recognized standard (e.g., certified
standard by NIST).
    9.1.3. All calibration activities will be documented and the
records retained.
    9.1.4. The source, lot, batch number, and expiration date of all
reagents used with be documented and retained.

9.2. Maintenance

    9.2.1. All equipment/instrumentation will be maintained in
accordance with the test method or the manufacturer's instructions
and may be scheduled or triggered.
    9.2.2. All maintenance activities will be documented and the
records retained.

9.3. Data Management and Handling

    9.3.1. All primary (raw) data will be correct, complete, without
selective reporting, and will be maintained.
    9.3.2. Hand-written data will be recorded in lab notebooks or
electronically at the time of observation.
    9.3.3. All hand-written records will be legible and amenable to
reproduction by electrostatic copiers.
    9.3.4. All changes to data or other records will be made by:
    a. Using a single line to mark-through the erroneous entry
(maintaining original data legibility).
    b. Write the revision.
    c. Initial, date, and provide revision code (see attached or
laboratory's equivalent).
    9.3.5. All data entry, transcriptions, and calculations will be
verified by a qualified person.
    a. Verification will be documented by initials of verifier and
date.
    9.3.6. Procedures will be in place to address data management
procedures used (at minimum):
    a. Significant figures.
    b. Rounding practices.
    c. Identification of outliers in data series.
    d. Required statistics.

9.4. Document Control

    9.4.1. All technical procedures, methods, work instructions,
standard operating procedures must be documented and approved by
laboratory management prior to the implementation.
    9.4.2. All primary data will be maintained by the contractor for
a minimum of five (5) years.

9.5. Personnel and Training

    9.5.1. Only qualified personnel shall perform laboratory
activities.
    9.5.2. Records of staff training and experience will be
available. This will include initial and refresher training (as
appropriate).

9.6. Test Performance

    9.6.1. All testing will done in accordance with the specified
test methods.
    9.6.2. Receipt, arrival condition, storage conditions,
dispersal, and accountability of the test article will be documented
and maintained.
    9.6.3. Receipt or production, arrival or initial condition,
storage conditions, dispersal, and accountability of the test matrix
(e.g., sediment or artificial seawater) will be documented and
maintained.
    9.6.4. Source, receipt, arrival condition, storage conditions,
dispersal, and accountability of the test organisms (including
inoculum) will be documented and maintained.
    9.6.5. Actual concentrations administered at each treatment
level will be verified by appropriate methodologies.
    9.6.6. Any data originating at a different laboratory will be
identified and the laboratory fully referenced in the final report.

9.7. The following references identify analytical methods that have
historically been successful for achieving the analytical quality
criteria.

    9.7.1. Continental Shelf Associates Report 1998. Joint EPA/
Industry Screening Survey to Assess the Deposition of Drill Cuttings
and Associated Synthetic Based Mud on the Seabed of the Louisiana
Continental Shelf, Gulf of Mexico. Analysis by Charlie Henry Report
Number IES/RCAT97-36 GC-FID and GC/MS.
    9.7.2. EPA Method 3550 for extraction with EPA Method 8015 for
GC-FID. EPA Method 3550C, Revision 3. February 2007. Ultrasonic
Extraction. EPA Method 8015C, Revision 3. February 2007.
Nonhalogenated Organics by Gas Chromatography.
    9.7.3. Chandler, J.E., S.P. Rabke, and A.J.J. Leuterman. 1999.
Predicting the Potential Impact of Synthetic-Based Muds With the Use
of Biodegradation Studies. Society of Petroleum Engineers SPE 52742.
    9.7.4. Chandler, J.E., B. Lee, S.P. Rabke, J.M. Geliff, R.
Stauffer, and J. Hein. 2000. Modification of a Standardized
Anaerobic Biodegradation Test to Discriminate Performance of Various
Non-Aqueous Base Fluids. Society of Petroleum Engineers SPE 61203.
    9.7.5. Munro, P.D., B Croce, C.F. Moffet, N.A Brown, A.D.
McIntosh, S.J. Hird, and R.M. Stagg. 1998. Solid-Phase Test for
Comparison for Degradation Rates of Synthetic Mud Base Fluids Used
in the Off-shore Drilling Industry. Environ. Toxicol. Chem. 17:1951-
1959.
    9.7.6. Webster, L., P.R. Mackie, S.J. Hird, P.D. Munro, N.A.
Brown, and C.F. Moffat. 1997. Development of Analytical Methods for
the Determination of Synthetic Mud Base Fluids in Marine Sediments.
The Analyst 122:1485-1490.
    9.8 The following standards are approved for incorporation by
reference by the Director of the Federal Register in accordance with
5 U.S.C. 552(a) and 1 CFR part 51. Copies may also be inspected at
EPA's Water Docket, 1200 Pennsylvania Ave. NW., Washington, DC 20460
and at at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call
202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    9.8.1 ASTM International. Available from ASTM International, 100
Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428-2959,
or online at http://www.astm.org.
    <IP_ADDRESS> ASTM D5291-96, Standard Test Methods for Instrumental
Determination of Carbon, Hydrogen, and Nitrogen in Petroleum
Products and Lubricants, approved April 10, 1996.
    <IP_ADDRESS> ASTM D2974-07a, Standard Test Methods for Moisture, Ash,
and Organic Matter of Peat and Other Organic Soils, approved March
15, 2007.

0
26. Amend Appendix 5 to Subpart A of Part 435 by:
0
a. Revising the appendix heading.
0
b. Removing ``35 to 500 amu'' and adding in its place ``35 to 600 amu''
in Section 6.3.2.
0
c. Revising section 9.5. introductory text.
0
d. Revising the equation in section 9.5.2.
0
e. Revising sections 9.6, 11.3 introductory text, 11.3.1, and <IP_ADDRESS>.
0
f. Adding section 6.17.

Appendix 5 to Subpart A of Part 435-- Determination of Crude Oil
Contamination in Non-Aqueous Drilling Fluids by Gas Chromatography/Mass
Spectrometry (GC/MS) (EPA Method 1655)

* * * * *
    9.5 Duplicates--A duplicate field sample shall be prepared and
analyzed according to Section 11. The relative percent difference
(RPD) of the calculated concentrations shall be less than 15%.
* * * * *
[GRAPHIC] [TIFF OMITTED] TR18MY12.029

    9.6 A clean NAF sample shall be prepared and analyzed according
to Section 11. Ultimately the oil-equivalent concentration from the
TIC or EIP signal measured in the clean NAF sample shall be
subtracted from the corresponding authentic field samples in order
to calculate the true contaminant concentration (% oil) in the field
samples (see Section 12).
* * * * *
    11.3 Qualitative Identification--See Section 17 of this method
for schematic flowchart.
    11.3.1 Qualitative identification shall be accomplished by
comparison of the TIC and EIP area data from an authentic sample to
the TIC and EIP area data from the calibration standards (see
Section 10.4). Crude oil shall be identified by the presence of
C10 to C13 n-alkanes and corresponding target
aromatics.
* * * * *
    <IP_ADDRESS> Asphaltene crude oils with API gravity <20 may not
produce chromatographic peaks strong enough to show contamination at
levels of the calibration. Extracted ion peaks should be easier to
see than increased intensities for the C8 to C13 peaks. If a sample
of asphaltene crude from the formation is available, a calibration
standard shall be prepared.
BILLING CODE 6560-50-P

[GRAPHIC] [TIFF OMITTED] TR18MY12.030

BILLING CODE 6560-50-C

0
27. The heading of Appendix 6 to Subpart A of Part 435 is revised to
read as follows:

Appendix 6 to Subpart A of Part 435-- Reverse Phase Extraction (RPE)
Method for Detection of Oil Contamination in Non-Aqueous Drilling
Fluids (NAF) (GC/MS) (EPA Method 1670)

* * * * *

0
28. The heading of Appendix 7 to Subpart A of Part 435 is revised to
read as follows:

Appendix 7 to Subpart A of Part 435-- Determination of the Amount of
Non-Aqueous Drilling Fluid (NAF) Base Fluid From Drill Cuttings by a
Retort Chamber (Derived From API Recommended Practice 13B-2) (EPA
Method 1674)

* * * * *

0
29. Appendix 8 to Subpart A of Part 435 is amended by:
0
a. Revising the second paragraph.
0
b. Adding ``>'' before ``11-14'' in Table 1.

Appendix 8 to Subpart A of Part 435--Reference C16-
C18 Internal Olefin Drilling Fluid Formulation

* * * * *
    Drilling fluid sediment toxicity ratio = 4-day LC50
of C16-C18 internal olefin drilling fluid/4-
day LC50 of drilling fluid removed from drill cuttings at
the solids control equipment as determined by EPA Method 1644:
``Method for Conducting a Sediment Toxicity Test with Leptocheirus
plumulosus and Non-Aqueous Drilling Fluids or Synthetic-Based
Drilling Muds'' after sediment preparation procedures specified in
EPA Method 1646, which are published as appendices to Subpart A of
this part and in ``Analytic Methods for the Oil and Gas Extraction
Point Source Category,'' EPA-821-R-11-004. See Sec.  435.11(ee) and
(uu).
* * * * *

Subpart D--Coastal Subcategory

0
30. Section 435.41 is amended:
0
a. By revising paragraph (d).
0
b. By revising paragraph (e).
0
c. By revising paragraph (k).
0
d. By revising paragraph (m)(2).
0
e. By revising paragraph (q).
0
f. By revising paragraph (r).
0
g. By amending paragraph (w) to remove ``LC5'' and add in
its place ``LC50''.
0
h. By revising paragraph (y).
0
i. By revising paragraph (ee).
0
j. By revising paragraph (ff).
0
k. By adding paragraph (mm).

Sec.  435.41  Special definitions.

* * * * *
    (d) Base fluid retained on cuttings as applied to BAT effluent
limitations and NSPS refers to the ``Determination of the Amount of
Non-Aqueous Drilling Fluid (NAF) Base Fluid from Drill Cuttings by a
Retort Chamber (Derived from API Recommended Practice 13B-2)'', EPA
Method 1674, which is published as an appendix to Subpart A of this
part and in ``Analytic Methods for the Oil and Gas Extraction Point
Source Category,'' EPA-821-R-11-004. See paragraph (mm) of this
section.
    (e) Biodegradation rate as applied to BAT effluent limitations and
NSPS for drilling fluids and drill cuttings refers to the ``Protocol
for the Determination of Degradation of Non Aqueous Base Fluids in a
Marine Closed Bottle Biodegradation Test System: Modified ISO
11734:1995,'' EPA Method 1647, supplemented with ``Procedure for Mixing
Base Fluids With Sediments,'' EPA Method 1646. Both EPA Method 1646 and
1647 are published as appendices to Subpart A of this part and in
``Analytic Methods for the Oil and Gas Extraction Point Source
Category,'' EPA-821-R-11-004. See paragraph (mm) of this section.
* * * * *
    (k) Diesel oil refers to the grade of distillate fuel oil, as
specified in the American Society for Testing and Materials Standard
Specification for Diesel Fuel Oils D975-91, that is typically used as
the continuous phase in conventional oil-based drilling fluids. This
incorporation by reference was approved by the Director of the Federal
Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies
may be obtained from the American Society for Testing and Materials,
100 Barr Harbor Drive, West Conshohocken, PA 19428. Copies may be
inspected at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. A copy may also be
inspected at EPA's Water Docket, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460.
* * * * *
    (m) * * *
    (2) Dry drill cuttings means the residue remaining in the retort
vessel after completing the retort procedure specified in EPA Method
1674, which is published as an appendix to Subpart A of this part and
in ``Analytic Methods for the Oil and Gas Extraction Point Source
Category,'' EPA-821-R-11-004. See paragraph (mm) of this section.
* * * * *
    (q) Formation oil means the oil from a producing formation which is
detected in the drilling fluid, as determined by the GC/MS compliance
assurance method, EPA Method 1655, when the drilling fluid is analyzed
before being shipped offshore, and as determined by the RPE method, EPA
Method 1670, when the drilling fluid is analyzed at the offshore point
of discharge. The GC/MS compliance assurance method and the RPE method
approved for use with this part are published as appendices to Subpart
A of this part and in ``Analytic Methods for the Oil and Gas Extraction
Point Source Category,'' EPA-821-R-11-004. See paragraph (mm) of this
section. Detection of formation oil by the RPE method may be confirmed
by the GC/MS compliance assurance method, and the results of the GC/MS
compliance assurance method shall supersede those of the RPE method.
    (r) Garbage means all kinds of victual, domestic, and operational
waste, excluding fresh fish and parts thereof, generated during the
normal operation of coastal oil and gas facility and liable to be
disposed of continuously or periodically, except dishwater, graywater,
and those substances that are defined or listed in other Annexes to
MARPOL 73/78. A copy of MARPOL may be inspected at EPA's Water Docket,
1200 Pennsylvania Ave. NW., Washington, DC 20460.
* * * * *
    (y) No discharge of free oil means that waste streams may not be
discharged that contain free oil as evidenced by the monitoring method
specified for that particular stream, e.g., deck drainage or
miscellaneous discharges cannot be discharged when they would cause a
film or sheen upon or discoloration of the surface of the receiving
water; drilling fluids or cuttings may not be discharged when they fail
EPA Method 1617 (Static Sheen Test), which is published as an appendix
to Subpart A of this part and in ``Analytic Methods for the Oil and Gas
Extraction Point Source Category,'' EPA-821-R-11-004. See paragraph
(mm) of this section.
* * * * *
    (ee) SPP toxicity as applied to BAT effluent limitations and NSPS
for drilling fluids and drill cuttings refers to the bioassay test
procedure, ``Suspended Particulate Phase (SPP) Toxicity Test,''
presented in EPA Method 1619, which is published as an appendix to
Subpart A of this part and in ``Analytic Methods for the Oil and Gas
Extraction Point Source Category,'' EPA-821-R-11-004. See paragraph
(mm) of this section.
    (ff) Static sheen test means the standard test procedure that has
been

developed for this industrial subcategory for the purpose of
demonstrating compliance with the requirement of no discharge of free
oil. The methodology for performing the static sheen test is presented
in EPA Method 1617, which is published as an appendix to Subpart A of
this part and in ``Analytic Methods for the Oil and Gas Extraction
Point Source Category,'' EPA-821-R-11-004. See paragraph (mm) of this
section.
* * * * *
    (mm) Analytic Methods for the Oil and Gas Extraction Point Source
Category is the EPA document, EPA-821-R-11-004, that compiles analytic
methods for this category. Copies may be inspected at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER>, or go to:
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. A copy may also be inspected at EPA's
Water Docket, 1200 Pennsylvania Ave. NW., Washington, DC 20460. This
method may be obtained at http://water.epa.gov/scitech/methods/cwa/index.cfm.

0
31. In Sec.  435.42 footnote 1 to the table is revised to read as
follows:

Sec.  435.42  Effluent limitations guidelines representing the degree
of effluent reduction attainable by the application of the best
practicable control technology currently available (BPT).

* * * * *
    \1\ No discharge of free oil. See Sec.  435.41(y).
* * * * *

0
32. In Sec.  435.43:
0
a. Remove ``LC5'' and add in its place ``LC50''
in the table.
0
b. Footnotes 2 and 4 to the table are revised to read as follows:

Sec.  435.43  Effluent limitations guidelines representing the degree
of effluent reduction attainable by the application of the best
available technology economically achievable (BAT).

* * * * *
    \2\ As determined by the static sheen test. See Sec.
435.41(ff).
* * * * *
    \4\ As determined by the suspended particulate phase (SPP)
toxicity test. See Sec.  435.41(ee).
* * * * *

0
33. In Sec.  435.44 footnote 2 to the table is revised to read as
follows:

Sec.  435.44  Effluent limitations guidelines representing the degree
of effluent reduction attainable by the application of the best
conventional pollutant control technology (BCT).

* * * * *
    \2\ As determined by the static sheen test. See Sec.
435.41(ff).
* * * * *

0
34. In Sec.  435.45:
0
a. Remove ``LC5'' and add in its place ``LC50''in
the table.
0
b. Footnotes 2 and 4 to the table are revised to read as follows:

Sec.  435.45  Standards of performance for new sources (NSPS).

* * * * *
    \2\ As determined by the static sheen test. See Sec.
435.41(ff).
* * * * *
    \4\ As determined by the suspended particulate phase (SPP)
toxicity test. See Sec.  435.41(ee).
* * * * *
[FR Doc. 2012-10210 Filed 5-17-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 107 (Tuesday, June 4, 2019)]
[Notices]
[Page 25802]
[FR Doc No: 2019-11590]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER19-1992-000]

RE Gaskell West 2 LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
RE Gaskell West 2 LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is June 17, 2019.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the website that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: May 28, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-11590 Filed 6-3-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: November 15, 2006 (Volume 71, Number 220)]
[Notices]
[Page 66510]
[DOCID:fr15no06-43]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL06-72-003]

PPL EnergyPlus, LLC v. New York Independent System Operator,
Inc.; Notice of Filing

November 6, 2006.
    Take notice that on October 27, 2006, New York Independent System
Operator, Inc. filed a status report, pursuant to the Commission's June
29, 2006 Order, concerning the New York Independent System Operator,
Inc and its stakeholders' consideration of changing the method for
allocating Import Rights to external Installed Capacity.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time, November 17, 2006.

Magalie R. Salas,
Secretary.
[FR Doc. E6-19213 Filed 11-14-06; 8:45 am]

BILLING CODE 6717-01-P


Morro Bay Losses species stage year impinged. est entrained. est notes dummy dummy  9  9  9 dummy anchovies1 age01 2000 54170 0 # 30009, Table 4 2 topsmelt age01 2000 4124 0 # 30009, Table 4 2 plainfin. midshipman age01 2000 3944 0 # 30009, Table 4 2 speckled. sanddab age01 2000 2345 0 # 30009, Table 4 2 pacific. staghorn. sculpin age01 2000 1512 0 # 30009, Table 4 2 california. tonguefish age01 2000 1374 0 # 30009, Table 4 2 english. sole age01 2000 1032 0 # 30009, Table 4 2 pacific. sardine age01 2000 421 0 # 30009, Table 4 2 shiner. surfperch age01 2000 364 0 # 30009, Table 4 2 cabezon age01 2000 349 0 # 30009, Table 4 2 thornback age01 2000 316 0 # 30009, Table 4 2 bay. pipefish age01 2000 290 0 # 30009, Table 4 2 pacific. sanddab age01 2000 274 0 # 30009, Table 4 2 pipefish age01 2000 272 0 # 30009, Table 4 2 lingcod age01 2000 224 0 # 30009, Table 4 2 spotted. cusk. eel age01 2000 194 0 # 30009, Table 4 2 basketweave. cusk. eel age01 2000 187 0 # 30009, Table 4 2 bat. ray age01 2000 173 0 # 30009, Table 4 2 medusafish age01 2000 130 0 # 30009, Table 4 2 walleye. surfperch age01 2000 100 0 # 30009, Table 4 2 sculpin. artedius. spp age01 2000 98 0 # 30009, Table 4 2 striped. surfperch age01 2000 98 0 # 30009, Table 4 2 smoothhead. sculpin age01 2000 92 0 # 30009, Table 4 2 tubesnout age01 2000 85 0 # 30009, Table 4 2 white. surfperch age01 2000 79 0 # 30009, Table 4 2 barred. surfperch age01 2000 78 0 # 30009, Table 4 2 rockfish age01 2000 76 0 # 30009, Table 4 2 kelp. pipefish age01 2000 72 0 # 30009, Table 4 2 black. rockfish age01 2000 70 0 # 30009, Table 4 2 black. surfperch age01 2000 59 0 # 30009, Table 4 2 sculpin. cottidae age01 2000 52 0 # 30009, Table 4 2 grass. rockfish age01 2000 51 0 # 30009, Table 4 2 kelp. rockfish age01 2000 51 0 # 30009, Table 4 2 dover. sole age01 2000 45 0 # 30009, Table 4 2 penpoint. gunnel age01 2000 40 0 # 30009, Table 4 2 kelp. rockfish juvenile 2000 39 0 # 30009, Table 4 2 kelp. greenling age01 2000 38 0 # 30009, Table 4 2 rainbow. surfperch age01 2000 38 0 # 30009, Table 4 2 pacific. butterfish age01 2000 38 0 # 30009, Table 4 2 sanddab age01 2000 36 0 # 30009, Table 4 2 black. and. yellow. rockfish age01 2000 35 0 # 30009, Table 4 2 pacific. electric. ray age01 2000 35 0 # 30009, Table 4 2 northern. clingfish age01 2000 34 0 # 30009, Table 4 2 pile. surfperch age01 2000 32 0 # 30009, Table 4 2 surfperch age01 2000 29 0 # 30009, Table 4 2 fluffy. sculpin age01 2000 29 0 # 30009, Table 4 2 prickleback age01 2000 27 0 # 30009, Table 4 2 silverside age01 2000 26 0 # 30009, Table 4 2 gopher. rockfish age01 2000 24 0 # 30009, Table 4 2 white. croaker age01 2000 22 0 # 30009, Table 4 2 jacksmelt age01 2000 20 0 # 30009, Table 4 2 striped. kelpfish age01 2000 19 0 # 30009, Table 4 2 smelt age01 2000 19 0 # 30009, Table 4 2 olive. rockfish age01 2000 19 0 # 30009, Table 4 2 rockweed. gunnel age01 2000 18 0 # 30009, Table 4 2 clinid. kelpfish age01 2000 16 0 # 30009, Table 4 2 kelp. gunnel age01 2000 16 0 # 30009, Table 4 2 rockpool. blenny age01 2000 15 0 # 30009, Table 4 2 crevice. kelpfish age01 2000 14 0 # 30009, Table 4 2 c. o. turbot age01 2000 14 0 # 30009, Table 4 2 curlfin. turbot age01 2000 14 0 # 30009, Table 4 2 bocaccio age01 2000 14 0 # 30009, Table 4 2 pygmy. poacher age01 2000 13 0 # 30009, Table 4 2 Morro Bay Losses gunnel. prickleback age01 2000 13 0 # 30009, Table 4 2 copper. rockfish age01 2000 13 0 # 30009, Table 4 2 giant. kelpfish age01 2000 13 0 # 30009, Table 4 2 unidentified. fish larvae 2000 13 0 # 30009, Table 4 2 black. and. yellow. gopher. rockfish juvenile 2000 13 0 # 30009, Table 4 2 poacher age01 2000 12 0 # 30009, Table 4 2 night. smelt age01 2000 12 0 # 30009, Table 4 2 rockfish juvenile 2000 10 0 # 30009, Table 4 2 sculpin. clinocottus. spp age01 2000 8 0 # 30009, Table 4 2 surfperch juvenile 2000 8 0 # 30009, Table 4 2 onespot. fringehead age01 2000 8 0 # 30009, Table 4 2 chilipepper age01 2000 8 0 # 30009, Table 4 2 herrings1 age01 2000 7 0 # 30009, Table 4 2 sharksucker age01 2000 7 0 # 30009, Table 4 2 slender. sole age01 2000 7 0 # 30009, Table 4 2 longjaw. mudsucker age01 2000 7 0 # 30009, Table 4 2 clingfish age01 2000 7 0 # 30009, Table 4 2 ratfish age01 2000 7 0 # 30009, Table 4 2 bay. goby age01 2000 7 0 # 30009, Table 4 2 snubnose. sculpin age01 2000 7 0 # 30009, Table 4 2 brown. rockfish age01 2000 7 0 # 30009, Table 4 2 pricklebreast. poacher age01 2000 7 0 # 30009, Table 4 2 manacled. sculpin age01 2000 7 0 # 30009, Table 4 2 leopard. shark age01 2000 7 0 # 30009, Table 4 2 rock. prickleback age01 2000 7 0 # 30009, Table 4 2 high. cockscomb age01 2000 6 0 # 30009, Table 4 2 bonyhead. sculpin age01 2000 6 0 # 30009, Table 4 2 kelp. surfperch age01 2000 6 0 # 30009, Table 4 2 spotfin. surfperch age01 2000 6 0 # 30009, Table 4 2 mussel. blenny age01 2000 6 0 # 30009, Table 4 2 ribbon. prickleback age01 2000 6 0 # 30009, Table 4 2 sand. sole age01 2000 6 0 # 30009, Table 4 2 pacific. mackerel age01 2000 6 0 # 30009, Table 4 2 spotted. scorpionfish age01 2000 6 0 # 30009, Table 4 2 black. rockfish juvenile 2000 6 0 # 30009, Table 4 2 black. and. yellow. rockfish juvenile 2000 6 0 # 30009, Table 4 2 gunnel age01 2000 5 0 # 30009, Table 4 2 starry. flounder age01 2000 5 0 # 30009, Table 4 2 market. squid age01 2000 16814 0 # 30009, Table 4 3 black. tailed. bay. shrimp age01 2000 7524 0 # 30009, Table 4 3 xantus. swimming. crab age01 2000 4834 0 # 30009, Table 4 3 hairy. rock. crab age01 2000 3898 0 # 30009, Table 4 3 brown. rock. crab age01 2000 3894 0 # 30009, Table 4 3 northern. kelp. crab age01 2000 3209 0 # 30009, Table 4 3 cancer. crab. cancer. spp age01 2000 3142 0 # 30009, Table 4 3 purple. sea. urchin age01 2000 1269 0 # 30009, Table 4 3 cryptic. kelp. crab age01 2000 1111 0 # 30009, Table 4 3 spotted. bay. shrimp age01 2000 1072 0 # 30009, Table 4 3 brown. shrimp age01 2000 1024 0 # 30009, Table 4 3 moss. crab age01 2000 763 0 # 30009, Table 4 3 red. rock. crab age01 2000 580 0 # 30009, Table 4 3 slender. crab age01 2000 444 0 # 30009, Table 4 3 cancer. antennarius. cancer. jordani age01 2000 415 0 # 30009, Table 4 3 striped. shore. crab age01 2000 388 0 # 30009, Table 4 3 tidepool. shrimp age01 2000 294 0 # 30009, Table 4 3 octopus age01 2000 293 0 # 30009, Table 4 3 bay. shrimp age01 2000 270 0 # 30009, Table 4 3 yellow. crab age01 2000 264 0 # 30009, Table 4 3 dungeness1 age01 2000 248 0 # 30009, Table 4 3 thickclaw. porcelain. crab age01 2000 211 0 # 30009, Table 4 3 shrimp. pandalus. spp age01 2000 154 0 # 30009, Table 4 3 franciscan. bay. shrimp age01 2000 100 0 # 30009, Table 4 3 pubescent. porcelain. crab age01 2000 75 0 # 30009, Table 4 3 cancer. magister. cancer. gracilis age01 2000 75 0 # 30009, Table 4 3 spider. crab. loxorhynchus. spp age01 2000 61 0 # 30009, Table 4 3 Morro Bay Losses black. clawed. crab. lophopanopeus. spp age01 2000 58 0 # 30009, Table 4 3 kelp. crab age01 2000 47 0 # 30009, Table 4 3 twistclaw. pistol. shrimp age01 2000 46 0 # 30009, Table 4 3 sharp. nosed. crab age01 2000 43 0 # 30009, Table 4 3 hippolytid. shrimp age01 2000 33 0 # 30009, Table 4 3 hemphils. kelp. crab age01 2000 32 0 # 30009, Table 4 3 dwarf. crab age01 2000 31 0 # 30009, Table 4 3 porcelain. crab age01 2000 28 0 # 30009, Table 4 3 graceful. kelp. crab age01 2000 21 0 # 30009, Table 4 3 broken. back. shrimp age01 2000 18 0 # 30009, Table 4 3 purple. shore. crab age01 2000 16 0 # 30009, Table 4 3 spot. shrimp age01 2000 16 0 # 30009, Table 4 3 sidestriped. shrimp age01 2000 14 0 # 30009, Table 4 3 dock. shrimp age01 2000 14 0 # 30009, Table 4 3 oriental. shrimp age01 2000 12 0 # 30009, Table 4 3 blue. mud. shrimp age01 2000 12 0 # 30009, Table 4 3 red. sea. urchin age01 2000 11 0 # 30009, Table 4 3 black. clawed. crab. lophopanopeus. leucomanus age01 2000 10 0 # 30009, Table 4 3 elbow. crab age01 2000 8 0 # 30009, Table 4 3 yellow. shore. crab age01 2000 7 0 # 30009, Table 4 3 spider. crab. majidae age01 2000 7 0 # 30009, Table 4 3 pistol. shrimp age01 2000 7 0 # 30009, Table 4 3 california. spiny. lobster age01 2000 7 0 # 30009, Table 4 3 majid. crab age01 2000 7 0 # 30009, Table 4 3 mole. crab age01 2000 7 0 # 30009, Table 4 3 spider. crab. mimulus. foliatus age01 2000 6 0 # 30009, Table 4 3 alaskan. bay. shrimp age01 2000 6 0 # 30009, Table 4 3 stout. bodied. shrimp age01 2000 6 0 # 30009, Table 4 3 goby larvae 2000 0 393261027 # 30009, Table 5 1 pacific. staghorn. sculpin larvae 2000 0 17321398 # 30009, Table 5 1 northern. lampfish larvae 2000 0 14548803 # 30009, Table 5 1 shadow. goby larvae 2000 0 13503587 # 30009, Table 5 1 combtooth. blenny larvae 2000 0 10042151 # 30009, Table 5 1 kgb. rockfish. sebastes. spp. V. De larvae 2000 0 6406622 # 30009, Table 5 1 jacksmelt larvae 2000 0 6266107 # 30009, Table 5 1 blackeye. goby larvae 2000 0 3777821 # 30009, Table 5 1 longjaw. mudsucker larvae 2000 0 3286095 # 30009, Table 5 1 bay. goby larvae 2000 0 3233197 # 30009, Table 5 1 herrings1 larvae 2000 0 3030431 # 30009, Table 5 1 white. croaker larvae 2000 0 2992511 # 30009, Table 5 1 cabezon larvae 2000 0 2888498 # 30009, Table 5 1 silverside larvae 2000 0 2719944 # 30009, Table 5 1 topsmelt larvae 2000 0 2574977 # 30009, Table 5 1 rockfish. sebastes. spp. V larvae 2000 0 2452533 # 30009, Table 5 1 blue. lanternfish larvae 2000 0 2212908 # 30009, Table 5 1 anchovies1 larvae 2000 0 2135787 # 30009, Table 5 1 larvae. fish. damaged larvae 2000 0 1283324 # 30009, Table 5 1 clinid. kelpfish larvae 2000 0 1140737 # 30009, Table 5 1 ronquil larvae 2000 0 1118752 # 30009, Table 5 1 sculpin. cottidae larvae 2000 0 1009206 # 30009, Table 5 1 smoothhead. sculpin larvae 2000 0 739011 # 30009, Table 5 1 sculpin. oligocottus. spp larvae 2000 0 620093 # 30009, Table 5 1 prickleback larvae 2000 0 615886 # 30009, Table 5 1 tube. blenny larvae 2000 0 550501 # 30009, Table 5 1 monkeyface. eel larvae 2000 0 505467 # 30009, Table 5 1 popeye. blacksmelt larvae 2000 0 494554 # 30009, Table 5 1 sculpin. artedius. spp larvae 2000 0 455238 # 30009, Table 5 1 wooly. sculpin larvae 2000 0 443530 # 30009, Table 5 1 unidentified. fish larvae 2000 0 406824 # 30009, Table 5 1 painted. greenling larvae 2000 0 373259 # 30009, Table 5 1 smelt larvae 2000 0 364054 # 30009, Table 5 1 rockfish. sebastes. spp. VD larvae 2000 0 353631 # 30009, Table 5 1 blind. goby larvae 2000 0 347224 # 30009, Table 5 1 pipefish larvae 2000 0 344816 # 30009, Table 5 1 snubnose. sculpin larvae 2000 0 338578 # 30009, Table 5 1 Morro Bay Losses snailfish larvae 2000 0 326003 # 30009, Table 5 1 roughcheek. sculpin larvae 2000 0 275533 # 30009, Table 5 1 righteye. flounder larvae 2000 0 266884 # 30009, Table 5 1 starry. flounder larvae 2000 0 266824 # 30009, Table 5 1 rockfish. sebastes. spp larvae 2000 0 239169 # 30009, Table 5 1 pacific. sandlance larvae 2000 0 221882 # 30009, Table 5 1 rockfish. sebastes. spp larvae 2000 0 212813 # 30009, Table 5 1 pacific. sanddab larvae 2000 0 189540 # 30009, Table 5 1 gunnel larvae 2000 0 134989 # 30009, Table 5 1 labrisomid. kelpfish larvae 2000 0 130625 # 30009, Table 5 1 greenling larvae 2000 0 130497 # 30009, Table 5 1 bay. pipefish larvae 2000 0 126957 # 30009, Table 5 1 blenny larvae 2000 0 117086 # 30009, Table 5 1 california. halibut larvae 2000 0 100329 # 30009, Table 5 1 speckled. sanddab larvae 2000 0 97108 # 30009, Table 5 1 english. sole larvae 2000 0 91928 # 30009, Table 5 1 croaker larvae 2000 0 87979 # 30009, Table 5 1 clingfish larvae 2000 0 86615 # 30009, Table 5 1 poacher larvae 2000 0 86165 # 30009, Table 5 1 prickly. sculpin larvae 2000 0 85742 # 30009, Table 5 1 rock. sole larvae 2000 0 79358 # 30009, Table 5 1 pipefish larvae 2000 0 59729 # 30009, Table 5 1 tidepool. sculpin larvae 2000 0 57168 # 30009, Table 5 1 broadfin. lampfish larvae 2000 0 52713 # 30009, Table 5 1 sand. sole larvae 2000 0 51915 # 30009, Table 5 1 lefteye. flounder larvae 2000 0 40213 # 30009, Table 5 1 pacific. sardine larvae 2000 0 39714 # 30009, Table 5 1 rockfish. sebastes. spp larvae 2000 0 39528 # 30009, Table 5 1 tubesnout larvae 2000 0 38690 # 30009, Table 5 1 sanddab larvae 2000 0 35396 # 30009, Table 5 1 rockfish. sebastes. spp larvae 2000 0 34617 # 30009, Table 5 1 queenfish larvae 2000 0 31563 # 30009, Table 5 1 fringehead larvae 2000 0 31525 # 30009, Table 5 1 flatfish larvae 2000 0 29598 # 30009, Table 5 1 diamond. turbot larvae 2000 0 20885 # 30009, Table 5 1 ribbonfish larvae 2000 0 17671 # 30009, Table 5 1 pacific. hake larvae 2000 0 17082 # 30009, Table 5 1 lampfish larvae 2000 0 16379 # 30009, Table 5 1 combfish larvae 2000 0 15565 # 30009, Table 5 1 red. brotula larvae 2000 0 15431 # 30009, Table 5 1 medusafish larvae 2000 0 15374 # 30009, Table 5 1 lanternfish larvae 2000 0 14187 # 30009, Table 5 1 longfin. lanternfish larvae 2000 0 14098 # 30009, Table 5 1 sculpin. ruscarius. spp larvae 2000 0 14036 # 30009, Table 5 1 hatchet. fish larvae 2000 0 13957 # 30009, Table 5 1 herrings1 larvae 2000 0 13772 # 30009, Table 5 1 grunt larvae 2000 0 13674 # 30009, Table 5 1 hornyhead. turbot larvae 2000 0 13079 # 30009, Table 5 1 sculpin. icelinus. spp larvae 2000 0 13049 # 30009, Table 5 1 aurora. rockfish larvae 2000 0 12295 # 30009, Table 5 1 brown. rock. crab megalopae 2000 0 9744688 # 30009, Table 5 2 hairy. rock. crab megalopae 2000 0 1965950 # 30009, Table 5 2 yellow. crab megalopae 2000 0 1116099 # 30009, Table 5 2 slender. crab megalopae 2000 0 470025 # 30009, Table 5 2 cancer. crab. cancer. spp megalopae 2000 0 140217 # 30009, Table 5 2 red. rock. crab megalopae 2000 0 85705 # 30009, Table 5 2 dungeness1 megalopae 2000 0 54650 # 30009, Table 5 2 Data Entry for Morro Bay Compiled by M. Barron and J. Hazen, 10/ 03/ 02.

Worksheet Description Losses01 Impingement and entrainment data. QC ed by J. Hazen 10/ 3/ 02.

Documents Used: Ref ID Tenera Environmental. 2001. Morro Bay Power Plant Modernization Project: 316( b) Resource Assessment. Prepared for Duke Energy Morro Bay, LLC. July 10. 30009 Information on Rockfish and how larval groups are defined is on p. 3 8 of # 30009. Rockfish include several species that are not identified as such like chilipepper or bocaccio.

Other Documents Reviewed and Not Used: Ref ID http:// www. energy. ca. gov/ sitingcases/ morrobay/ documents/ 2002 04 24_ FSA_ PART3. PDF Other potential sources of data Species potential data reference cited in Yellow crab ( use data for hairy rock crab too?); red rock crab fecundity, growth, survival Carroll and Winn 1982 # 30009 p. 5 37 Yellow crab ( use data for hairy rock crab too?); red rock crab fecundity, growth, survival Anderson and Ford # 30009 p. 5 39 slender. crab early life history, survival Ally 1975; Orensanz and Gallucci 1988 # 30009 p. 5 41 red. rock. crab fecundity, growth, survival Starr et al, 1998 # 30009 p. 5 42 dungeness. crab fecundity, growth, survival Reilly 1983 # 30009 p. 5 44 lots ? Love 1996 # 30009 p. 4 19


[Federal Register Volume 80, Number 139 (Tuesday, July 21, 2015)]
[Rules and Regulations]
[Pages 43015-43017]
[FR Doc No: 2015-17843]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2015-0647]
RIN 1625-AA00

Safety Zone; Maritime Museum Party, San Diego Bay; San Diego, CA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on the
navigable waters of the San Diego Bay for a fireworks display on the
evening of July 23, 2015. This action is necessary to provide for the
safety of the participants, crew, spectators, participating vessels,
and other vessels and users of the waterway. Persons and vessels are
prohibited from entering into, transiting through, or anchoring within
this safety zone unless authorized by the Captain of the Port or his
designated representative.

DATES:  This rule is effective from 8:30 p.m. to 9:30 p.m. on July 23,
2015.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2015-0647]. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Petty Officer Nick Bateman, Waterways Management, U.S.
Coast Guard Sector San Diego; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Cheryl Collins, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
TFR Temporary Final Rule

A. Regulatory History and Information

    The Coast Guard is issuing this temporary final rule safety zone
for a planned fireworks show on San Diego Bay 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 publishing an NPRM would be impracticable
because immediate action is needed to minimize potential danger to the
participants and the public during the event. Furthermore, the
necessary information to determine whether the marine event poses a
threat to persons and vessels was provided 15 days before the event,
which is insufficient time to publish an NPRM. Because fireworks barges
on the navigable waterways poses significant risk to public safety and
property and the likely combination of large numbers of recreation
vessels and congested waterways could easily result in serious injuries
or fatalities, this safety zone is necessary to safeguard spectators,
vessels and the event participants. For the safety concerns noted, it
is important to have these regulations in effect during the event and
impracticable to delay the regulations.
    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 these same reasons, the Coast
Guard finds good cause for implementing this rule less than thirty days
before the effective July 23, 2015.

B. Basis and Purpose

    The legal basis and authorities for this temporary rule are found
in 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and
160.5; and Department of Homeland Security Delegation No. 0170.1, which
collectively authorize the Coast Guard to propose, establish, and
define regulatory safety zones.
    The Coast Guard believes establishing a temporary safety zone on
the navigable waters of the San Diego Bay is necessary to ensure public
safety for the fireworks display. A temporary safety zone will provide
for the safety of the event participants, spectators, safety vessels,
and other public users of the waterway. This event involves a planned
fifteen minute fireworks display on a portion of San Diego Bay.

C. Discussion of the Final Rule

    The Coast Guard is establishing a temporary safety zone that will
be enforced from 8:30 p.m. to 9:30 p.m. on July 23, 2015. This safety
zone is necessary to provide for the safety of the event participants,
event spectators, safety patrol craft and to protect other vessels and
users of the waterway. Persons and vessels will be prohibited from
entering into, transiting through, or anchoring within this safety zone
unless authorized by the Captain of the Port, or their designated
representative. Before the effective period, the Coast Guard will
publish a local notice to mariners (LNM). Just prior to the event and
during the enforcement of the event, the Coast Guard will issue a
broadcast notice to mariners (BNM) alert via VHF Channel 16.

    This temporary safety zone will be bound by a 600 foot radius of
the fireworks barge, center approximately on the following coordinate
(North American Datum of 1983, World Geodetic System, 1984):
32[deg]43.14 N, 117[deg]10.36 W

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on these statutes and executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders. We expect the economic
impact of this rule to be so minimal that a full Regulatory Evaluation
is unnecessary. This determination is based on the size, location and
limited duration of the safety zone. This zone impacts a small
designated area of the San Diego bay for less than one hour.
Furthermore, vessel traffic can safely transit around the safety zone.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 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 will affect the following entities, some of
which may be small entities: The owners or operators of private and
commercial vessels intending to transit or anchor in the impacted
portion of the San Diego Bay from 8:30 p.m. through 9:30 p.m. on July
23, 2015.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons. Vessel
traffic can pass safely around the zone. The Coast Guard will publish a
local notice to mariners (LNM) and will issue broadcast notice to
mariners (BNM) alerts via VHF Channel 16 before the safety zone is
enforced.

3. Assistance for Small Entities

    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,
above.
    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.

4. 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).

5. Federalism

    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 determined
that this rule does not have implications for federalism.

6. 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.

7. 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.

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

11. Indian Tribal Governments

    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.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security

Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (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 the establishment of a safety zone on
the navigable waters of San Diego Bay. This rule is categorically
excluded from further review under paragraph 34(g) of Figure 2-1 of the
Commandant Instruction. An environmental analysis checklist supporting
this determination and a Categorical Exclusion Determination are
available in the docket where indicated under ADDRESSES. We seek any
comments or information that may lead to the discovery of a significant
environmental impact from this rule.

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.
0170.01.

0
2. Add Sec.  165.T11-647 to read as follows:

Sec.  165.T11-647  Safety Zone; Maritime Museum Party; San Diego, CA.

    (a) Location. The limits of the safety zone will include all the
navigable waters within 600 feet of the fireworks barge in approximate
position of 32[deg]43.14 N, 117[deg]10.36 W (North American Datum of
1983, World Geodetic System, 1984).
    (b) Enforcement period. This section will be enforced from 8:30
p.m. to 9:30 p.m. on July 23, 2015. If the event concludes prior to the
schedule termination time, the COTP will cease enforcement of this
safety zone and will announce that fact via Broadcast Notice to
Mariners.
    (c) Definitions. The following definition applies to this section:
Designated representative means any commissioned, warrant, or petty
officer of the Coast Guard on board Coast Guard, Coast Guard Auxiliary,
or local, state, or federal law enforcement vessels who have been
authorized to act on the behalf of the Captain of the Port.
    (d) Regulations. (1) Under the general regulations in subpart C of
this part, entry into, transit through or anchoring within this safety
zone is prohibited unless authorized by the Captain of the Port of San
Diego or his designated representative.
    (2) All persons and vessels shall comply with the instructions of
the Coast Guard Captain of the Port or his designated representative.
    (3) Upon being hailed by U.S. Coast Guard or designated patrol
personnel by siren, radio, flashing light or other means, the operator
of a vessel shall proceed as directed.
    (4) The Coast Guard may be assisted by other federal, state, or
local agencies in patrol and notification of the regulation.

    Dated: July 10, 2015.
J.S. Spaner,
Captain, U.S. Coast Guard, Captain of the Port San Diego.
[FR Doc. 2015-17843 Filed 7-20-15; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 86, Number 30 (Wednesday, February 17, 2021)]
[Notices]
[Pages 9943-9944]
[FR Doc No: 2021-03173]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Docket No. FDA-2021-N-0088]

Cellular, Tissue and Gene Therapies Advisory Committee; Notice of
Meeting; Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Cellular, Tissue and Gene
Therapies Advisory Committee. The general function of the committee is
to provide advice and recommendations to FDA on scientific issues. The
meeting will be open to the public. FDA is establishing a docket for
public comment on this document.

DATES: The meeting will be held on April 15, 2021, from 10 a.m. to 6
p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of the COVID-19 pandemic,
all meeting participants will be joining this advisory committee
meeting via an online teleconferencing platform. Answers to commonly
asked questions about FDA advisory committee meetings may be accessed
at: https://www.fda.gov/advisory-committees/about-advisory-committees/common-questions-and-answers-about-fda-advisory-committee-meetings. The
online web conference meeting will be available at the following link
on the day of the meeting: https://youtu.be/qufQ5NO2aYE.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2021-N-0088. The docket will close on April
14, 2021. Submit either electronic or written comments on this public
meeting on or before April 14, 2021. Please note that late, untimely
filed comments will not be considered. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of April 14, 2021. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.
    Comments received on or before April 8, 2021, will be provided to
the committee. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is cancelled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-N-0088 for ``Cellular, Tissue and Gene Therapies Advisory
Committee; Notice of Meeting; Establishment of a Public Docket; Request
for Comments.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA will review
this copy, including the claimed confidential information, in its
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify the information as ``confidential.'' Any
information marked as ``confidential'' will not be disclosed except in
accordance with 21 CFR 10.20 and other applicable disclosure law. For
more information about FDA's posting of comments to public dockets, see
80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Jarrod Collier or Joanne Lipkind,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6268, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area). A notice in the Federal Register about last-minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to

learn about possible modifications before coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. On April 15,
2021, the committee will discuss biologics license application (BLA)
125734 for donislecel (purified allogeneic deceased donor pancreas
derived islets of Langerhans). The applicant, CellTrans, Inc., has
requested an indication for the ``treatment of brittle Type 1 diabetes
mellitus (T1D).'' The morning session will discuss issues related to
the characterization and critical quality attributes of donislecel as
they relate to product comparability in the context of consistent
product quality and clinical effectiveness. The afternoon session will
discuss results from the clinical trials included in BLA 125734.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available on FDA's website at
the time of the advisory committee meeting. Background material and the
link to the online teleconference meeting room will be available at
https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll
down to the appropriate advisory committee meeting link. The meeting
will include slide presentations with audio components to allow the
presentation of materials in a manner that most closely resembles an
in-person advisory committee meeting.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see
ADDRESSES) on or before April 8, 2021, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 1:45 p.m. and 2:45 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before March 31, 2021. Time allotted for
each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by April 1, 2021.
    For press inquiries, please contact the Office of Media Affairs at
<EMAIL_ADDRESS>or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Jarrod Collier at<EMAIL_ADDRESS>(see FOR FURTHER
INFORMATION CONTACT) at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/advisory-committees/about-advisory-committees/public-conduct-during-fda-advisory-committee-meetings for procedures on public conduct during
advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: February 10, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03173 Filed 2-16-21; 8:45 am]
BILLING CODE 4164-01-P