[Federal Register Volume 88, Number 15 (Tuesday, January 24, 2023)]
[Proposed Rules]
[Pages 4120-4128]
[FR Doc No: 2023-00835]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 261

[EPA-R06-RCRA-2022-0780; FRL-10237-01-Region 6]

Hazardous Waste Management System; Identification and Listing of
Hazardous Waste Proposed Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
grant an exclusion from the list of hazardous wastes to ExxonMobil
Baytown Refinery (EMBR or Petitioner) located in Baytown, Texas. This
action responds to

a petition to exclude (or ``delist'') up to 730 cubic yards per year of
sludges removed from the wastewater treatment plant (WWTP) from the
list of federal hazardous wastes when disposed of in a Subtitle D
landfill under the Resource Conservation Recovery Act (RCRA). The EPA
is proposing to grant the petition based on an evaluation of waste-
specific information provided by Petitioner.

DATES: Comments on this proposed exclusion must be received by February
23, 2023.

ADDRESSES: Submit your comments by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Email: [email protected].
    Instructions: The EPA must receive your comments by February 23,
2023. Direct your comments to Docket ID Number EPA-R06-RCRA-2022-0780.
The EPA's policy is that all comments received will be included in the
public docket without change and may be made available online at
https://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI), or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through https://www.regulations.gov or email. The Federal regulations.gov website is an
``anonymous access'' system, which means the EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an email comment directly to the EPA without
going through regulations.gov, your email address will be automatically
captured and included as part of the comment that is placed in the
public docket and made available on the internet. If you submit an
electronic comment, the EPA recommends that you include your name and
other contact information in the body of your comment with any CBI you
submit. If the EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, the EPA may not
be able to consider your comment. Electronic files should avoid the use
of special characters, any form of encryption and be free of any
defects or viruses.
    Docket: The index to the docket for this action is available
electronically at www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy.
    You can view and copy the delisting petition and associated
publicly available docket materials either through www.regulations.gov
or at: EPA, Region 6, 1201 Elm Street, Suite 500, Dallas, Texas 75270.
The EPA facility is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding Federal holidays and facility closures due to COVID-
19. The EPA recommend that you telephone Harry Shah, at<PHONE_NUMBER>,
before visiting the Region 6 office. Interested persons wanting to
examine these documents should make an appointment with the office.

FOR FURTHER INFORMATION CONTACT: Harry Shah,<PHONE_NUMBER>,
[email protected]. Out of an abundance of caution for members of the
public and our staff, the EPA Region 6 office may be closed to the
public to reduce the risk of transmitting COVID-19. The EPA encourages
the public to submit comments via https://www.regulations.gov, as there
will be a delay in processing mail and no courier or hand deliveries
will be accepted. Please call or email the contact listed above if you
need alternative access to material indexed but not provided in the
docket.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Overview Information
II. Background
    A. What is the history of the delisting program?
    B. What is a delisting petition, and what does it require of a
petitioner?
    C. What factors must the EPA consider in deciding whether to
grant a delisting petition?
    D. Environmental Justice Evaluation
III. The EPA's Evaluation of the Waste Information and Data
    A. What waste did the Petitioner petition the EPA to delist?
    B. How did the Petitioner generate the waste?
    C. How did the Petitioner sample and analyze the petitioned
waste?
    D. What factors did the EPA consider in deciding whether to
propose to grant the delisting petition?
    E. How did the EPA evaluate the risk of delisting this waste?
    F. What did the EPA conclude?
IV. Conditions for Exclusion
    A. How will the Petitioner manage the waste if it is delisted?
    B. What are the maximum allowable concentrations of hazardous
constituents in the waste?
    C. How frequently must the Petitioner test the waste?
    D. What data must the Petitioner submit?
    E. What happens if the Petitioner fails to meet the conditions
of the exclusion?
    F. What must the Petitioner do if the process changes?
V. When would the EPA finalize the proposed delisting exclusion?
VI. How would this action affect states?
VII. Statutory and Executive Order Reviews

I. Overview Information

    The EPA is proposing to grant a May 2021 petition (``F037 Delisting
Petition'') request submitted by EMBR in Baytown, Texas to exclude (or
``delist'') up to 730 cubic yards per year of F037 WWTP sludge from the
list of federal hazardous waste set forth in 40 CFR 261.3 (hereinafter,
all sectional references are to 40 CFR unless otherwise indicated) for
offsite disposal. The Petitioner claims that the petitioned wastes do
not meet the criteria for which the EPA listed it, and that there are
no additional constituents or factors which could cause the waste to be
hazardous. Based on our review described in section III, the EPA
propose to approve the petition request, and allow the delisted waste
to be disposed in a Subtitle D landfill. A copy of the May 2021
petition is located in the docket to this proposal action.

II. Background

A. What is the history of the delisting program?

    The EPA published an amended list of hazardous wastes from non-
specific and specific sources on January 16, 1981, as part of its final
and interim final regulations implementing section 3001 of RCRA. The
EPA has amended this list several times and codifies the list in
Sec. Sec.  261.31 and 261.32.
    The EPA lists the Petitioner's wastes as hazardous because: (1) the
wastes typically and frequently exhibit one or more of the
characteristics of hazardous wastes identified in subpart C of part 261
(that is, ignitability, corrosivity, reactivity, and toxicity), (2) the
wastes meet the criteria for listing contained in Sec.  261.11(a)(2) or
(3), or (3) the wastes are mixed with or derived from the treatment,
storage or disposal of such characteristic and listed wastes and which
therefore become hazardous under Sec.  261.3(a)(2)(iv) or (c)(2)(i),
known as the ``mixture'' or ``derived-from'' rules, respectively.
    Individual waste streams may vary, however, depending on raw
materials, industrial processes, and other factors. Thus, while a waste
described in these part 261 regulations or resulting from the operation
of the mixture or derived-from rules generally is hazardous, a

specific waste from an individual facility may not be hazardous.
    For this reason, 40 CFR 260.20 and 260.22 provide an exclusion
procedure, called delisting, which allows persons to prove that the EPA
should not regulate a specific waste from a particular generating
facility as a hazardous waste.

B. What is a delisting petition, and what does it require of a
petitioner?

    A delisting petition is a request from a facility to the EPA or an
authorized state to exclude wastes from the list of hazardous wastes.
The facility petitions the EPA because it does not consider the waste
as hazardous under RCRA regulations.
    In a delisting petition, the petitioner must show that wastes
generated at a particular facility do not meet any of the criteria for
which the waste was listed. The criteria for which the EPA lists a
waste are in 40 CFR part 261 and further explained in the background
documents for the listed waste in the June 30, 1992 publication of the
``Final Best Demonstrated Available Technology (BDAT) Background
Document for Newly Listed Refinery Wastes F037 and F038'' (https://nepis.epa.gov/Exe/ZyNET.exe/P100VUGS.TXT?ZyActionD=ZyDocument&Client=EPA&Index=1991+Thru+1994&Docs=&Query=&Time=&EndTime=&SearchMethod=1&TocRestrict=n&Toc=&TocEntry=&QField=&QFieldYear=&QFieldMonth=&QFieldDay=&IntQFieldOp=0&ExtQFieldOp=0&XmlQuery=&File=D%3A%5Czyfiles%5CIndex%20Data%5C91thru94%5CTxt%5C00000035%5CP100VUGS.txt&User=ANONYMOUS&Password=anonymous&SortMethod=h%7C-&MaximumDocuments=1&FuzzyDegree=0&ImageQuality=r75g8/r75g8/x150y150g16/i425&Display=hpfr&DefSeekPage=x&SearchBack=ZyActionL&Back=ZyActionS&BackDesc=Results%20page&MaximumPages=1&ZyEntry=1&SeekPage=x&ZyPURL).
    In addition, under 40 CFR 260.22, a petitioner must prove that the
waste does not exhibit any of the hazardous waste characteristics (that
is, ignitability, reactivity, corrosivity, and toxicity) and must
present sufficient information for the EPA to decide whether factors
other than those for which the waste was listed warrant retaining it as
a hazardous waste.
    Generators remain obligated under RCRA to confirm whether their
waste remains non-hazardous based on the hazardous waste
characteristics even if the EPA has ``delisted'' the waste.

C. What factors must the EPA consider in deciding whether to grant a
delisting petition?

    Besides considering the criteria in 40 CFR 260.22(a) and 3001(f) of
RCRA, 42 U.S.C. 6921(f), and in the background documents for the listed
wastes, the EPA must consider any factors (including additional
constituents) aside from those for which the EPA listed the waste, if a
reasonable basis exists that these additional factors could cause the
waste to be hazardous.
    The EPA must also consider hazardous waste mixtures containing
listed hazardous wastes and wastes derived from treating, storing, or
disposing of listed hazardous waste. See Sec.  261.3(a)(2)(iii) and
(iv) and (c)(2)(i), called the ``mixture'' and ``derived-from'' rules,
respectively. These wastes are also eligible for exclusion and remain
hazardous wastes until excluded. See 66 FR 27266 (May 16, 2001).

D. Environmental Justice Evaluation

    To better meet the EPA's ``responsibilities related to the
protection of public health and the environment, the EPA has developed
a new environmental justice (EJ) mapping and screening tool called EJ
Screen'' that reports values as a percentile when compared to a state
or the nation. ``It is based on nationally consistent data and an
approach that combines environmental and demographic indicators in maps
and reports,'' (https://www.epa.gov/ejscreen). The EPA is providing
analysis of environmental justice associated with this action. The EPA
are doing so for the purpose of providing information to the public,
not as a basis of our final action.
    The EPA utilized EJ Screen to evaluate potential environmental
justice concerns in communities at one-, three-, and five-mile radiuses
around the Baytown facility. The EPA considers the potential for EJ
concerns in a community when one or more of the 12 EJ indices is at or
above the 80th percentile when compared to the rest of the USA. At the
one-mile radial measurement, all 12 EJ indices exceeded the 80th
percentile, at the three-mile measurement, 11 out of the 12 EJ indices
exceeded the 80th percentile, and at the five-mile radial measurement,
four EJ indices exceeded the 80th percentile. This information is
provided in Table 1. More information on EJ Screen, including an
explanation of the 12 EJ indices can be found at www.epa.gov/ejscreen/what-ejscreen.

                 Table 1--EJ Indices at One-, Three-, and Five-Mile Radiuses Around the Facility
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                                                                   1 Mile radius   3 Mile radius   5 Mile radius
                    EJ index (USA percentile)                       around the      around the      around the
                                                                     facility        facility        facility
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EJ Index for Particulate Matter 2.5.............................              86              81              74
EJ Index for Ozone..............................................              82              77              72
EJ Index for 2017 Diesel Particulate Matter.....................              86              82              77
EJ Index for 2017 Air Toxics Cancer Risk........................              95              89              79
EJ Index for 2017 Air Toxics Respiratory HI.....................              88              82              75
EJ Index for Traffic Proximity..................................              83              81              78
EJ Index for Lead Paint.........................................              84              82              79
EJ Index for Superfund Proximity................................              87              87              84
EJ Index for RMP Facility Proximity.............................              97              94              88
EJ Index for Hazardous Waste Proximity..........................              86              81              74
EJ Index for Underground Storage Tanks..........................              86              85              81
EJ Index for Wastewater Discharge...............................              90              87              85
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III. The EPA's Evaluation of the Waste Information and Data

A. What waste did the Petitioner petition the EPA to delist?

    In May 2021, EMBR petitioned the EPA to exclude from the list of
hazardous wastes contained in Sec.  261.31, WWTP solids (F037)
generated from its facility located in Baytown, Texas. The waste falls
under the classification of listed waste pursuant to Sec.  261.31.
Specifically, in its petition, EMBR requested that the EPA grant a
standard exclusion for 730 cubic yards per year of the WWTP solids for
offsite disposal.

B. How did the Petitioner generate the waste?

    Per the definition provide in 40 CFR 261.31, an F037 listed
hazardous waste is any sludge generated from the gravitational
separation of oil/water/solids during the storage or treatment of
process wastewaters and oily cooling wastewaters from petroleum
refineries. Such sludges also include sludge generated from
gravitational separation in stormwater units receiving dry weather
flow. The preseparators receive industrial wastewater generated at the
ExxonMobil Baytown Complex, comprised of the Baytown Olefins Plant,
Baytown Chemical Plant, and the Baytown Refinery, as part of the WWTP.
The sludge separates from the process wastewaters in the primary
treatment/storage systems, making it an F037 waste stream by
definition. Under routine operating conditions, the primary separation
sludge is generated at the preseparators; however, during infrequent
and isolated times of non-routine elevated wastewater flows, temporary
storage/conveyance of dry weather industrial wastewater may occur in
the stormwater impoundments (e.g. Upper Outfall Canal or Stormwater
Retention Basin) where primary separation will occur. The sludge is
collected in the units for removal and disposal.

C. How did the Petitioner sample and analyze the petitioned waste?

    A total of twelve (3 samples per month for 4 months) acceptable
sample results were provided by Petitioner to support the petition. The
EPA considered all 12 samples of the WWTP solids and the disposal
scenario of the landfill was modeled using the Delisting Risk
Assessment Software. The worst-case scenario of the constituents'
concentrations for the F037 sludge were used as input in the model to
determine if it would meet the hazardous waste criteria for which it
was listed. The maximum total and leachate concentrations for the
inorganic and organic constituents which were found in the analytical
data provided by Petitioner are presented in Table 2.

             Table 2--Maximum Total and TCLP Concentrations
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                                     Maximum total       Maximum TCLP
          Chemical Name           concentration (mg/  concentration (mg/
                                          kg)                 l)
------------------------------------------------------------------------
Acenaphthene....................                 3.6              0.0037
Acenapthylene...................                 2.3              0.0003
Acetone (2-propanone)...........                0.12               0.046
Aniline (benzeneamine)..........                 4.5              0.0014
Anthracene......................                0.14              0.0008
Antimony........................                3.17              0.0362
Arsenic.........................                11.9              0.0486
Barium..........................                 221               0.862
Benz(a)anthracene...............                 8.1              0.0003
Benzene.........................                0.54               0.012
Benzo(a)pyrene..................                 6.9              0.0004
Benzo(b)fluoranthene............                 9.9              0.0004
Benzo(ghi)perylene..............                 4.1              0.0003
Benzo(k)fluoranthene............                 5.8              0.0007
Beryllium.......................                1.12              0.0002
Bis(2-ethylhexyl)phthalate......                0.45              0.0008
Cadmium.........................               0.494               0.002
Chromium (III) (Chromic Ion)....                62.4               0.151
Chrysene........................                  11              0.0008
Cobalt..........................                5.61              0.0236
Copper..........................                 127               0.308
Cresol m-.......................                 6.1               0.026
Cresol o-.......................                  16               0.055
Cresol p-.......................                  16               0.055
DDD.............................               0.013            2.00E-05
DDE.............................               0.013            2.00E-05
DDT p,p'-.......................               0.031            2.50E-05
Dibenz(a,h)anthracene...........                 1.1              0.0006
Dibenzofuran....................                  21              0.0015
Dieldrin........................              0.0085            3.00E-05
Dimethylphenol, 2,4-............                 3.6               0.016
Diphenylamine...................                0.47                0.01
Endosulfan (Endosulfan I and                 0.03664            1.10E-05
 II,mixture)....................
Endrin..........................               0.025            3.00E-05
Ethyl methacrylate..............                0.11                0.02
Ethylbenzene....................                 2.2               0.013
Fluoranthene....................                  35              0.0004
Fluorene........................                  27              0.0036
HCH, alpha-                                   0.0022            4.90E-05
 (Hexachlorocyclohexane alpha-
 BHC)...........................
HCH, beta-                                      0.32            1.00E-05
 (Hexachlorocyclohexane beta-
 BHC)...........................
Heptachlor......................             0.00068            1.10E-05
Heptachlor epoxide..............               0.033            1.00E-05

Indeno (1,2,3-cd) pyrene........                 3.8              0.0006
Lead............................                94.3              0.0747
Mercury (Fish Pathway Only).....                1.95            0.000642
Mercury (Total).................                1.95            0.000642
Methoxychlor....................              0.0035             0.00015
Methylnapthalene 2-.............                  55               0.042
Naphthalene.....................                  63               0.023
Nickel..........................                 464                3.38
Nitrosodiphenylamine N-.........                0.47                0.01
Phenanthrene....................                  72              0.0051
Phenol..........................                  20               0.029
Pyrene..........................                  30              0.0003
Pyridine........................                0.43              0.0003
Selenium........................                1.86              0.0254
Silver..........................              0.0688               0.002
Styrene.........................                0.39                0.01
Tetrachlorodibenzo-p-dioxin                 2.00E-07            4.10E-06
 (TCDD) 2,3,7,8-................
Tin.............................                15.1              0.0289
Toluene.........................                 9.7               0.093
Trinitrobenzene (Trinitrobenzene                 0.5              0.0006
 1,3,5-) sym-...................
Vanadium........................                1110                36.1
Xylenes (total).................                  21               0.096
Zinc............................                 871                1.61
------------------------------------------------------------------------

D. What factors did the EPA consider in deciding whether to propose to
grant the delisting petition?

    In reviewing this petition, the EPA considered the original listing
criteria and the additional factors required by the Hazardous and Solid
Waste Amendments of 1984 (HSWA). See section 222 of HSWA, 42 U.S.C.
6921(f), and 40 CFR 260.22(d)(2) through (4). The EPA evaluated the
petitioned wastes against the listing criteria and factors cited in
Sec.  261.11(a)(2) and (3).
    In addition to the criteria in 40 CFR 260.22(a), 261.11(a)(2) and
(3), 42 U.S.C. 6921(f), and in the background documents for the listed
wastes, the EPA also considered factors (including additional
constituents) other than those for which the EPA listed the waste to
determine if these additional factors could cause the waste to be
hazardous (See the background documents).
    Our proposed decision to grant the May 2021 petition to delist the
waste from the Petitioner's facility in Baytown, Texas is based on our
evaluation of the wastes for factors or criteria which could cause the
waste to be hazardous. These factors included: (1) whether the waste is
considered acutely toxic; (2) the toxicity of the constituents; (3) the
concentration of the constituents in the waste; (4) the tendency of the
constituents to migrate and to bioaccumulate; (5) the persistence in
the environment of any constituents once released from the waste; (6)
plausible and specific types of management of the petitioned waste; (7)
the quantity of waste produced; and (8) waste variability.
    The EPA must also consider as hazardous wastes mixtures containing
listed hazardous wastes and wastes derived from treating, storing, or
disposing of listed hazardous waste. See 40 CFR 261.3(a)(2)(iv) and
(c)(2)(i), called the ``mixture'' and ``derived-from'' rules,
respectively. Mixture and derived-from wastes are also eligible for
exclusion but remain hazardous until excluded.

E. How did the EPA evaluate the risk of delisting this waste?

    For this proposed delisting determination, the EPA evaluated the
risk that the waste would be disposed of as a non-hazardous waste in a
landfill. The EPA considered transport of waste constituents through
groundwater, surface water and air. The EPA evaluated the Petitioner's
analysis of the petitioned waste using the Delisting Risk Assessment
Software (DRAS) to predict the concentration of hazardous constituents
that might be released from the petitioned waste and to determine if
the waste would pose a threat to human health and the environment. The
DRAS software and associated documentation can be found at www.epa.gov/hw/hazardous-waste-delisting-risk-assessment-software-dras.
    To predict the potential for release to groundwater from landfilled
wastes and subsequent routes of exposure to a receptor, the DRAS uses
dilution attenuation factors derived from the EPA's Composite Model for
leachate migration with transformation products. From a release to
groundwater, the DRAS considers routes of exposure to a human receptor
through ingestion of contaminated groundwater, inhalation from
groundwater while showering and dermal contact from groundwater while
bathing.
    From a release to surface water by erosion of waste from an open
landfill into storm water run-off, DRAS evaluates the exposure to a
human receptor by fish ingestion and ingestion of drinking water. From
a release of waste particles and volatile emissions to air from the
surface of an open landfill, DRAS considers routes of exposure of
inhalation of volatile constituents, inhalation of particles, and air
deposition of particles on residential soil and subsequent ingestion of
the contaminated soil by a child. The technical support document and
the user's guide to DRAS are available at https://www.epa.gov/hw/hazardous-waste-delisting-risk-assessment-software-dras.

F. What did the EPA conclude?

    Petitioner stated in its petition that the petitioned waste meets
the criteria of F037 for which the EPA listed it. Petitioner also
stated that no additional constituents or factors could cause the waste
to be hazardous. Petitioner also stated that disposal in a landfill
will not adversely impact human health and the environment. The EPA's
review of this

petition included consideration of the original listing criteria, and
the additional factors required by the Hazardous and Solid Waste
Amendments of 1984 (HSWA). See section 3001(f) of RCRA, 42 U.S.C.
6921(f), and Sec.  260.22 (d)(1) through (4). In making the initial
delisting determination, the EPA evaluated the petitioned waste against
the listing criteria and factors cited in Sec.  261.11(a)(2) and (3).
Based on this review, the EPA agrees with the Petitioner that the
petitioned waste is nonhazardous with respect to the original listing
criteria. (If the EPA had found, based on this review, that the waste
remained hazardous based on the factors for which the waste was
originally listed, the EPA would propose to deny the petition.) The EPA
evaluated the waste with respect to other factors or criteria to assess
whether there is a reasonable basis to believe that such additional
factors could cause the waste to be hazardous. The EPA considered
whether the waste is acutely toxic, the concentration of the
constituents in the waste, their tendency to migrate and to
bioaccumulate, their persistence in the environment once released from
the waste, plausible and specific types of management of the petitioned
waste, the quantities of waste generated, and waste variability. The
EPA believes that the petitioned waste does not meet the listing
criteria and thus, should not be a listed waste. The EPA's proposed
decision to delist the waste from the Petitioner's facility is based on
the information submitted in support of this proposed rule, including
descriptions of the wastes and analytical data from the Baytown, Texas
facility, and that is contained in the Petition and attachments, all of
which are included in the docket to this action.

IV. Conditions for Exclusion

A. How will the Petitioner manage the waste if it is delisted?

    If the petitioned wastes are delisted as proposed, the Petitioner
must dispose of them in a Subtitle D landfill which is permitted,
licensed, or registered by a state to manage industrial waste.

B. What are the maximum allowable concentrations of hazardous
constituents in the waste?

    The EPA notes that in some instances the maximum allowable total
constituent concentrations provided by the DRAS model exceed 100% of
the waste--these DRAS results are an artifact of the risk calculations
that do not have physical meaning. In instances where DRAS predicts a
maximum constituent greater than 100 percent of the waste (that is,
greater than 1,000,000 mg/kg or mg/L, respectively, for total and TCLP
concentrations), the EPA is not proposing to require the Petitioner to
perform sampling and analysis for that constituent and sampling type
(total or TCLP).

C. How frequently must the Petitioner test the waste?

    The testing approach for this waste stream will be conducted
annually during the second calendar quarter. Petitioner must conduct
annual sampling and analysis as described in the delisting sampling and
analysis plan and ensure that the wastes do not exceed the delisting
parameters. If any measured constituent concentration exceeds the
delisting levels set forth in Table 2, ExxonMobil must collect an
additional representative sample within 10 business days of being made
aware of the exceedance and test it expeditiously for the
constituent(s) which exceeded delisting levels in the original annual
sample. If compliance with the delisting parameters is demonstrated
with analytical testing (TCLP analysis), the Petitioner may dispose of
the WWTP sludge as a non-hazardous waste. The annual amount of sludge
disposed as delisted waste may not exceed 730 cubic yards. The annual
sampling report shall include the volume of sludge disposed of in the
landfill, as well as annual testing event data. The petitioner should
monitor and report increasing trends of constituents which will affect
the overall compliance with the discharge permit.

D. What data must the Petitioner submit?

    The Petitioner must submit the data obtained through verification
testing to U.S. EPA Region 6, Office of Land, Chemicals and
Redevelopment Division, 1201 Elm Street, Suite 500, M/C 6LCR-RP,
Dallas, Texas 75270-2102, within 30 business days after receiving the
final results from the laboratory. These results may be submitted
electronically to Harry Shah, [email protected]. The Petitioner must
make those records available for inspection. All data must be
accompanied by a signed copy of the certification statement in 40 CFR
260.22(i)(12).

E. What happens if the Petitioner fails to meet the conditions of the
exclusion?

    If this Petitioner violates the terms and conditions established in
the exclusion, the EPA may start procedures to withdraw the exclusion.
Additionally, the terms of the exclusion provide that ``[a]ny waste
volume for which representative composite sampling does not reflect
full compliance with the exclusion criteria must continue to be managed
as hazardous.''
    If the testing of the waste does not demonstrate compliance with
the delisting concentrations described in section IV.C above, or other
data (including but not limited to leachate data or groundwater
monitoring data from the final land disposal facility) relevant to the
delisted waste indicates that any constituent is at a concentration in
waste above specified delisting verification concentrations in Table 2,
the Petitioner must notify the EPA within 10 business days, or such
later date as the EPA may agree to in writing, after receiving the
final verification testing results from the laboratory or of first
possessing or being made aware of other relevant data. The EPA may
require the Petitioner to conduct additional verification sampling to
better define the particular volume of wastes within the affected unit
that does not fully satisfy delisting criteria. For any volume of
wastes for which the corresponding representative sample(s) do not
reflect full compliance with delisting exclusion levels, the exclusion
by its terms does not apply, and the waste must be managed as
hazardous.
    The EPA has the authority under RCRA and the Administrative
Procedures Act, 5 U.S.C. 551 (1978) et seq. to reopen a delisting
decision if the EPA receive new information indicating that the
conditions of this exclusion have been violated or, are otherwise not
being met.

F. What must the Petitioner do if the process changes?

    Any process changes or additions implemented at Petitioner's
facility which would significantly impact the constituent
concentrations of the waste must be reported to the EPA in accordance
with Condition VI. of the exclusion language.

V. When would the EPA finalize the proposed delisting exclusion?

    HSWA specifically requires the EPA to provide notice and an
opportunity for public comment before granting or denying a final
exclusion. Thus, the EPA will not make a final decision or grant an
exclusion until it has addressed all timely public comments, including
any at public hearings. Upon receipt and consideration of all comments,
the EPA will publish its final determination as a final rule. Since
this proposed rule would reduce the existing requirements for persons
generating hazardous

wastes, the regulated community does not need a six-month period to
come into compliance in accordance with section 3010 of RCRA, as
amended by HSWA.

VI. How would this action affect states?

    Because the EPA is proposing to issue this exclusion under the
federal RCRA delisting regulations, only states subject to federal RCRA
delisting provisions will be affected. This exclusion may not be
effective in states which have received authorization from the EPA to
make their own delisting decisions.
    RCRA allows states to impose more stringent regulatory requirements
than RCRA's under 3009 of RCRA. These more stringent requirements may
include a provision that prohibits a federally-issued exclusion from
taking effect in the state. The EPA urge Petitioners to contact the
state regulatory authority to establish the status of its wastes under
the state law.
    The EPA has also authorized some states to administer a delisting
program in place of the federal program, that is, to make state
delisting decisions. Therefore, this exclusion does not apply in those
states. If the Petitioner manages the wastes in any state with
delisting authorization, the Petitioner must obtain delisting
authorization or other determination from the receiving state before it
can manage the waste as nonhazardous in that state.

VII. Statutory and Executive Order Reviews

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

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

    This proposed action is exempt from review by the Office of
Management and Budget because it is a rule of particular applicability,
not general applicability. The proposed action approves a delisting
petition under RCRA for the petitioned waste at a particular facility.

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

    This proposed action is not an Executive Order 13771 regulatory
action because actions such as approval of delisting petitions under
RCRA are exempted under Executive Order 13771

C. Paperwork Reduction Act

    This proposed action does not impose an information collection
burden under the provisions of the Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.) because it only applies to a particular facility.

D. Regulatory Flexibility Act

    Because this proposed rule is of particular applicability relating
to a particular facility, it is not subject to the regulatory
flexibility provision of the Regulatory Flexibility Act (5 U.S.C. 601
et seq.).

E. Unfunded Mandates Reform Act

    This proposed action does not contain any unfunded mandate as
described in the Unfunded Mandates Reform Act (2 U.S.C. 1531-1538) and
does not significantly or uniquely affect small governments. The action
imposes no new enforceable duty on any state, local, or tribal
governments or the private sector.

F. Executive Order 13132: Federalism

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

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

    This proposed action does not have tribal implications as specified
in Executive Order 13175. This proposed action applies only to a
particular facility on non-tribal land. Thus, Executive Order 13175
does not apply to this action.

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

    This proposed action is not subject to Executive Order 13045
because it is not economically significant as defined in Executive
Order 13045 and because the EPA does not believe the environmental
health or safety risks addressed by this action present a
disproportionate risk to children. This proposed action's health and
risk assessments using the EPA's Delisting Risk Assessment Software
(DRAS), which considers health and safety risks to children, are
described in section III.E above. The technical support document and
the user's guide for DRAS are included in the docket.

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

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

J. National Technology Transfer and Advancement Act

    This proposed action does not involve technical standards as
described by the National Technology Transfer and Advancement Act of
1995 (15 U.S.C. 272 note).

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

    Executive Order 12898 (59 FR 7629, Feb. 16, 1994) directs Federal
agencies to identify and address ``disproportionately high and adverse
human health or environmental effects'' of their actions on minority
populations and low-income populations to the greatest extent
practicable and permitted by law. The EPA defines environmental justice
(EJ) as ``the fair treatment and meaningful involvement of all people
regardless of race, color, national origin, or income with respect to
the development, implementation, and enforcement of environmental laws,
regulations, and policies.'' The EPA further defines the term fair
treatment to mean that ``no group of people should bear a
disproportionate burden of environmental harms and risks, including
those resulting from the negative environmental consequences of
industrial, governmental, and commercial operations or programs and
policies,'' (https://www.epa.gov/environmentaljustice/learn-about-environmental-justice).
    The EPA believes that this proposed action does not have
disproportionately high and adverse human health or environmental
effects on minority populations, low-income populations, and/or
indigenous peoples. The EPA has determined that this proposed action
will not have disproportionately high and adverse human health or
environmental effects on minority or low-income populations because the
petitioned wastes do not meet the criteria that determines what
constitutes a hazardous waste and there are no additional constituents
or factors which could cause the waste to be hazardous. The EPA's risk
assessment, as described in section III.E above, did not identify risks
from management of this material in an authorized, solid waste landfill

(e.g., RCRA Subtitle D landfill, commercial/industrial solid waste
landfill, etc.). Therefore, the EPA believes that any populations in
proximity of the landfill(s) used by the Baytown facility should not be
adversely affected by common waste management practices for this
delisted waste.

L. Congressional Review Act

    This proposed action is exempt from the Congressional Review Act (5
U.S.C. 801 et seq.) because it is a rule of particular applicability.

List of Subjects in 40 CFR Part 261

    Environmental protection, Hazardous waste, Recycling, Reporting and
recordkeeping requirements.

    Dated: January 9, 2023.
Ronald Crossland,
Director, Land, Chemicals and Redevelopment Division.

    For the reasons set out in the preamble, the EPA proposes to amend
40 CFR part 261 as follows:

PART 261--IDENTIFICATION AND LISTING OF HAZARDOUS WASTE

0
1. The authority citation for part 261 continues to read as follows:

    Authority:  42 U.S.C. 6905, 6912(a), 6921, 6922, 6924(y) and
6938.

0
2. Amend Table 1 of Appendix IX to Part 261 by adding the entry
``ExxonMobil Baytown Refinery'' in alphabetical order to read as
follows:

Appendix IX to Part 261 Wastes Excluded Under Sec. Sec.  260.20 and
260.22

                               Table 1--Wastes Excluded From Non-Specific Sources
----------------------------------------------------------------------------------------------------------------
             Facility                        Address                            Waste description
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
ExxonMobil Baytown Refinery......  Baytown, Texas.............  Wastewater Treatment Plant Sludge (the EPA
                                                                 Hazardous Waste No. F037) maximum delisted
                                                                 amount of 730 cubic yards per calendar year
                                                                 after (date rule finalized) and disposed in a
                                                                 Subtitle D landfill. ExxonMobil must implement
                                                                 a verification program that meets the following
                                                                 Paragraphs:
                                                                (1) Delisting Levels: All leachable constituent
                                                                 concentrations must not exceed the following
                                                                 levels. The petitioner must use the method
                                                                 specified in 40 CFR 261.24 to measure
                                                                 constituents in the waste leachate (mg/L).
                                                                 Wastewater Treatment Plant Solids Leachate:
                                                                 Acenaphthene-107; Acetone-5220; Aniline-19.8;
                                                                 Anthracene-260; Antimony-1.23; Arsenic-0.129;
                                                                 Barium-100; Benz(a) anthracene-5.13; Benzene-
                                                                 0.5; Benzo(a)pyrene-1930; Beryllium-1.43;
                                                                 Cadmium-1.0; Chromium (III)-5.0; Chrysene-513;
                                                                 Cobalt-2.71; Copper-88.1; Cresol (total)-200;
                                                                 Dibenzofuran-5.91; 2,4-Dimethylphenol-114;
                                                                 Diphenylamine-387; Endosulfan-35.9; Endrin-
                                                                 0.05; Ethyl Methacrylate-2030; Ethylbenzene-
                                                                 7.88; Fluoranthrene-24.7; Fluorene-49.2; Beta
                                                                 HCH-0.0636; Heptachlor-0.008; Heptachlor
                                                                 epoxide-0.008; Lead-5.0; Mercury-0.2; 2-
                                                                 Methylnapthalene-7.29; Naphthalene-0.947;
                                                                 Nickel-136; N-Nitrosodiphenylamine-11.5; Phenol-
                                                                 1740; Pyrene-44.6; Pyridine-5; Selenium-1.0;
                                                                 Silver-5.0; Styrene-15.2; TCDD-467; Toluene-
                                                                 152; 1,3,5-Trinitrobenzene-174; Vanadium-41.7;
                                                                 Xylenes (total)-86.1; Zinc-1980.
                                                                (2) Waste Holding and Handling:
                                                                (A) Wastewater treatment plant sludge must be
                                                                 tested annually to assure they have met the
                                                                 concentrations described in Paragraph (1).
                                                                 Solids that do not meet the concentrations in
                                                                 the original and retest representative sample
                                                                 must be disposed of as hazardous waste.
                                                                (B) Levels of constituents measured in the
                                                                 samples of the solids that do not exceed the
                                                                 levels set forth in Paragraph (1) are non-
                                                                 hazardous. ExxonMobil can manage and dispose
                                                                 the non-hazardous WWTP solids according to all
                                                                 applicable solid waste regulations.
                                                                (C) ExxonMobil must maintain a record of the
                                                                 actual volume of the WWTP solids to be disposed
                                                                 in the Subtitle D landfill according to the
                                                                 requirements in Paragraph (4).
                                                                (3) Testing Requirements:
                                                                (A) ExxonMobil must test a representative sample
                                                                 of the WWTP sludge for all constituents listed
                                                                 in paragraph (1) at least once per calendar
                                                                 year. If any measured constituent concentration
                                                                 exceeds the delisting levels set forth in
                                                                 paragraph (1), ExxonMobil must collect an
                                                                 additional representative sample within 10
                                                                 business days of being made aware of the
                                                                 exceedance and test it expeditiously for the
                                                                 constituent(s) which exceeded delisting levels
                                                                 in the original annual sample.
                                                                (B) The annual testing report should include the
                                                                 total amount of delisted waste in cubic yards
                                                                 disposed during the calendar year.
                                                                (4) Changes in Operating Conditions: If
                                                                 ExxonMobil significantly changes the process
                                                                 described in its petition or starts any
                                                                 processes that may or could affect the
                                                                 composition or type of waste generated as
                                                                 established under Paragraph (1) (by
                                                                 illustration, but not limitation, changes in
                                                                 equipment or operating conditions of the
                                                                 treatment process), they must notify the EPA in
                                                                 writing during the annual report; they may no
                                                                 longer handle the wastes generated from the new
                                                                 process as nonhazardous until the test results
                                                                 of the wastes meet the delisting levels set in
                                                                 Paragraph (1).
                                                                (5) Data Submittals: ExxonMobil must submit the
                                                                 information described below. If ExxonMobil
                                                                 fails to submit the required data within the
                                                                 specified time or maintain the required records
                                                                 on-site for the specified time, the EPA, at its
                                                                 discretion, will consider this sufficient basis
                                                                 to reopen the exclusion as described in
                                                                 Paragraph 5. ExxonMobil must:
                                                                (A) Submit the data obtained through Paragraph 3
                                                                 to the Chief, RCRA Permits & Solid Waste
                                                                 Section, Mail Code, (6LCR-RP) US EPA Region 6,
                                                                 1201 Elm Street, Suite 500, Dallas, TX 75270
                                                                 within the time specified. Data may be
                                                                 submitted via email to the technical contact
                                                                 for the delisting program.
                                                                (B) Compile records of operating conditions and
                                                                 analytical data from Paragraph (3), summarized,
                                                                 and maintained on-site for a minimum of five
                                                                 years.
                                                                (C) Furnish these records and data when the EPA
                                                                 or the State of Texas request them for
                                                                 inspection.
                                                                (D) Send along with all data, a signed copy of
                                                                 the following certification statement, to
                                                                 attest to the truth and accuracy of the data
                                                                 submitted: ``Under civil and criminal penalty
                                                                 of law for the making or submission of false or
                                                                 fraudulent statements or representations
                                                                 (pursuant to the applicable provisions of the
                                                                 Federal Code, which include, but may not be
                                                                 limited to, 18 U.S.C. 1001 and 42 U.S.C. 6928),
                                                                 I certify that the information contained in or
                                                                 accompanying this document is true, accurate
                                                                 and complete. As to the (those) identified
                                                                 section(s) of this document for which I cannot
                                                                 personally verify its (their) truth and
                                                                 accuracy, I certify as the company official
                                                                 having supervisory responsibility for the
                                                                 persons who, acting under my direct
                                                                 instructions, made the verification that this
                                                                 information is true, accurate and complete. If
                                                                 any of this information is determined by the
                                                                 EPA in its sole discretion to be false,
                                                                 inaccurate or incomplete, and upon conveyance
                                                                 of this fact to the company, I recognize and
                                                                 agree that this exclusion of waste will be void
                                                                 as if it never had effect or to the extent
                                                                 directed by the EPA and that the company will
                                                                 be liable for any actions taken in
                                                                 contravention of the company's RCRA and CERCLA
                                                                 obligations premised upon the company's
                                                                 reliance on the void exclusion.''
                                                                (6) Reopener:

                                                                (A) If, any time after disposal of the delisted
                                                                 waste, ExxonMobil possesses or is otherwise
                                                                 made aware of any environmental data (including
                                                                 but not limited to leachate data or ground
                                                                 water monitoring data) or any other data
                                                                 relevant to the delisted waste indicating that
                                                                 any constituent identified for the delisting
                                                                 verification testing is at level higher than
                                                                 the delisting level allowed by the Division
                                                                 Director in granting the petition, then the
                                                                 facility must report the data, in writing, to
                                                                 the Division Director within 10 days of first
                                                                 possessing or being made aware of that data.
                                                                (B) If the verification testing of the waste
                                                                 does not meet the delisting requirements in
                                                                 Paragraph 1, ExxonMobil must report the data,
                                                                 in writing, to the Division Director within 10
                                                                 days of first possessing or being made aware of
                                                                 that data.
                                                                (C) If ExxonMobil fails to submit the
                                                                 information described in paragraphs (5), (6)(A)
                                                                 or (6)(B) or if any other information is
                                                                 received from any source, the Division Director
                                                                 will make a preliminary determination as to
                                                                 whether the reported information requires EPA
                                                                 action to protect human health or the
                                                                 environment. Further action may include
                                                                 suspending, or revoking the exclusion, or other
                                                                 appropriate response necessary to protect human
                                                                 health and the environment.
                                                                (D) If the Division Director determines that the
                                                                 reported information does require EPA action,
                                                                 the Division Director will notify the facility,
                                                                 in writing, of the actions the Division
                                                                 Director believes are necessary to protect
                                                                 human health and the environment. The notice
                                                                 shall include a statement of the proposed
                                                                 action and a statement providing the facility
                                                                 with an opportunity to present information as
                                                                 to why the proposed EPA action is not
                                                                 necessary. The facility shall have 10 business
                                                                 days from the date of the Division Director's
                                                                 notice to present such information.
                                                                (E) Following the receipt of information from
                                                                 the facility described in paragraph (6)(D) or
                                                                 (if no information is presented under paragraph
                                                                 (6)(D)) the initial receipt of information
                                                                 described in paragraphs (5), (6)(A) or (6)(B),
                                                                 the Division Director will issue a final
                                                                 written determination describing the EPA
                                                                 actions that are necessary to protect human
                                                                 health or the environment. Any required action
                                                                 described in the Division Director's
                                                                 determination shall become effective
                                                                 immediately, unless the Division Director
                                                                 provides otherwise.
                                                                (6) Notification Requirements: ExxonMobil must
                                                                 do the following before transporting the
                                                                 delisted waste: Failure to provide this
                                                                 notification will result in a violation of the
                                                                 delisting petition and a possible revocation of
                                                                 the decision.
                                                                (A) Provide a one-time written notification to
                                                                 any State Regulatory Agency to which, or
                                                                 through which they will transport the delisted
                                                                 waste described above for disposal, 60 days
                                                                 before beginning such activities. If ExxonMobil
                                                                 transports the excluded waste to or manages the
                                                                 waste in any state with delisting
                                                                 authorization, ExxonMobil must obtain delisting
                                                                 authorization from that state before it can
                                                                 manage the waste as nonhazardous in the state.
                                                                (B) Update the one-time written notification if
                                                                 they ship the delisted waste to a different
                                                                 disposal facility.
                                                                (C) Failure to provide the notification will
                                                                 result in a violation of the delisting variance
                                                                 and a possible revocation of the exclusion.

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

[FR Doc. 2023-00835 Filed 1-23-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 182 (Monday, September 21, 2015)]
[Notices]
[Pages 56982-56983]
[FR Doc No: 2015-23629]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9934-38-OW]

Environmental Financial Advisory Committee; Request for
Nominations of Candidates to the Environmental Financial Advisory Board

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of request for nominations of candidates to the
Environmental Financial Advisory Board.

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

SUMMARY: The United States Environmental Protection Agency (EPA)
invites nominations of qualified candidates to be considered for
appointments to fill vacancies on the Environmental Financial Advisory
Board (the Board or EFAB). The Board seeks to maintain diverse
representation across all workforce sectors and geographic locations.
Nominees should demonstrate experience in any of the following areas:
Environmental insurance; energy efficiency; commercial banking; local
utility management and finance; green infrastructure financing;
sustainable community partnerships; water resiliency; water and
wastewater utility financial management; public-public; public-private;
and public-nonprofit partnerships. Nominees are encouraged who live and
work in the pacific northwest, northeast, and mid-west parts of the
United States.
    EPA values and welcomes diversity. In an effort to obtain a diverse
pool of candidates, EPA encourages nominations of women and men of all
racial and ethnic groups. In addition to this notice, other sources may
be utilized in the solicitation of nominees. The deadline for receiving
nominations is Friday, October 9, 2015. Appointments will be made by
the Deputy Administrator of the Environmental Protection Agency and
will be announced in November 2015. Nominee qualifications will be
assessed under the mandates of the Federal

Advisory Committee Act, which requires Committees to maintain diversity
across a broad range of constituencies, sectors, and groups.

DATES: Nominations should be submitted in time to arrive no later than
October 9, 2015.

ADDRESSES: EPA, Office of Water, 1301 Constitution Avenue NW., (4102M),
Washington, DC 20004.

FOR FURTHER INFORMATION CONTACT: Submit nomination materials by postal
mail or electronic mail to: Pamela Scott, Membership Coordinator,
Environmental Financial Advisory Board, or email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Environmental Financial Advisory Board
was chartered in 1989 under the Federal Advisory Committee Act to
provide advice and recommendations to EPA on the following issues:
     Reducing the cost of financing environmental facilities
and discouraging polluting behavior;
     Creating incentives to increase private investment in the
provision of environmental services and removing or reducing
constraints on private involvement imposed by current regulations;
     Developing new and innovative environmental financing
approaches and supporting and encouraging the use of cost-effective
existing approaches;
     Identifying approaches specifically targeted to small/
disadvantaged community financing;
     Increasing the capacity of state and local governments to
carry out their respective environmental programs under current Federal
tax laws;
     Analyzing how new technologies can be brought to market
expeditiously;
     Increasing the total investment in environmental
protection of public and private environmental resources to help ease
the environmental financing challenge facing our nation.
    The Board meets two times each calendar year (two days per meeting)
at different locations within the continental United States. Board
members typically contribute approximately 1-3 hours per month to the
Board's work. The Board's membership services are voluntary and the
Agency is unable to provide honoraria or compensation, according to
FACA guidelines. However, Board members may receive travel and per diem
allowances, where appropriate, and in accordance with Federal Travel
Regulations for invitational travelers.
    Evaluation Criteria: The following criteria will be used to
evaluate nominees:
    [ssquf] Residence in the continental United States;
    [ssquf] Professional knowledge of, and experience with,
environmental financing activities;
    [ssquf] Senior level-experience that fills a gap in Board
representation, or brings a new and relevant dimension to its
deliberations;
    [ssquf] Demonstrated ability to work in a consensus-building
process with a wide range of representatives from diverse
constituencies; and
    [ssquf] Willingness to serve a two-year term as an active and
contributing member, with possible re-appointment to a second term.
    Nominations for membership must include a resume describing the
professional and educational qualifications of the nominee as well as
expertise/experience. Contact details should include full name and
title, business mailing address, telephone, fax, and email address. A
supporting letter of endorsement is encouraged but not required.

    Dated: September 10, 2015.
Andrew D. Sawyers,
Director, Office of Wastewater Management, Office of Water.
[FR Doc. 2015-23629 Filed 9-18-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: March 26, 2009 (Volume 74, Number 57)]
[Notices]
[Page 13213-13214]
[DOCID:fr26mr09-77]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0149]

Agency Emergency Processing Under Office of Management and Budget
Review; Guidance for Industry: Animal Generic Drug User Fees and Fee
Waivers and Reductions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for emergency processing under the
Paperwork Reduction Act of 1995 (the PRA). The proposed collection of
information concerns the burden hours required to implement the new
statutory requirements for the user fees and fee waivers reductions
provisions of the Animal Generic Drug User Fee Act of 2008 (AGDUFA)
(Federal Food, Drug, and Cosmetic Act (the act)).

DATES: Fax written comments on the collection of information provisions
by March 31, 2009.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-NEW and
title ``Guidance for Industry: Animal Generic Drug Fees and Fee Waivers
Reduction; Emergency Request.'' Also include the FDA docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management (HFA-710); Food and Drug Administration 5600
Fishers Lane Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: FDA is requesting emergency processing of
this proposed collection of information under section 3507(j) of the
PRA (44 U.S.C. 3507(j) and 5 CFR 1320.13). Section 741(d) of the act
(21 U.S.C. 379k(d)), as amended by AGDUFA, authorizes FDA to collect
user fees for certain: (1) Abbreviated applications for generic new
animal drugs, (2) new animal drug products, and (3) sponsors of such
abbreviated applications for generic new animal drugs and/or
investigational submissions of new animal drugs. However, AGDUFA also
provides FDA with the authorization to grant a waiver from or a
reduction of those fees in certain circumstances. To provide guidance,
FDA has developed the guidance entitled ``Animal Generic Drug User Fees
and Fee Waivers and Reductions,'' which is crucial to firms
understanding whether they might qualify for the waiver or reduction,
and if so, how to apply for it.
    With respect to the following collection of information FDA invites
comments on these topics: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.

Guidance for Industry: Animal Generic Drug User Fees and Fee Waivers
and Reductions (Section 741(d) of the Federal Food, Drug, and Cosmetic
Act); Emergency Request

    AGDUFA requires FDA to collect user fees for certain: (1)
Abbreviated applications for a generic new animal drug, (2) generic new
animal drug products, and (3) sponsors of such abbreviated applications
for generic new animal drugs and/or investigational submissions for
generic new animal drugs. AGDUFA also contains a specific provision
under which a fee waiver or reduction may be requested for any or all
of these fees. The type of fee waiver and reduction requests to be
submitted is: Minor Use or Minor Species. FDA seeks OMB approval for
this summary of information required for a fee waiver or reduction
request.
    Respondents to the proposed collection of information will likely
be private industry. Requests for a waiver or reduction may be
submitted by a person paying any of the generic new animal drug user
fees assessed--application fees, product fees, or sponsor fees.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Section 741(d) of        No. of        Annual Frequency     Total Annual        Hours per
     the Act          Respondents        per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
741(d)--Minor Use                  9                  1                  9                  2                 18
 or Minor Species
 Fee Waiver &
 Reduction
 Requests
----------------------------------------------------------------------------------------------------------------
Request for                        1                  1                  1                  1                  1
 Reconsideration;
 CVM AGDUFA
 Waiver
 Officer\2\
----------------------------------------------------------------------------------------------------------------
Request for                        1                  1                  1                  1                  1
 Review; CVM
 AGDUFA Appeals
 Officer
----------------------------------------------------------------------------------------------------------------
Request for                        1                  1                  1                  1                  1
 Review; FDA User
 Fee Appeals
 Officer
----------------------------------------------------------------------------------------------------------------
Total                                                                                21
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ CVM means Center for Veterinary Medicine.

    Appeals for reconsideration or review of AGDUFA user fee waiver
decisions will be very rare. Waivers are granted only for user fees
involving minor use or minor species as defined by the Minor Use and
Minor Species Act of 2008 (MUMS). Decisions on waivers of user fees
based on minor species do not allow for agency discretion as ``minor
species'' is defined specifically in the MUMS statute. As to minor use
in a major species, FDA, under MUMS, determines that a new animal drug
is for minor use in a major species at the time that the pioneer new
animal drug application is submitted. This determination carries over
to the abbreviated (generic) new animal drug application. Therefore, we
do not anticipate that there will be more than one request for review
or reconsideration for either the ``minor use'' or ``minor species''
waivers or reductions under AGDUFA per year.
    Fee Waiver or Reduction Requests: For those who, after reading the
guidance, decide to apply for a waiver or reduction of one or more of
the fees they were assessed, the time to complete the information
required for their waiver application, based on the guidance provided,
is estimated to be 2 hours or less.
    Based on FDA's database system, there are an estimated 50 sponsors
of products subject to AGDUFA. However, not all sponsors will have
submissions in a given year. CVM estimates nine waiver requests that
include minor use or minor species. The estimated hours per response
are based on past FDA experience with the various waiver requests in
CVM. The hours per response listed in table 1 of this document are
based on the average of these estimates.

    Dated: March 19, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-6724 Filed 3-25-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 88, Number 114 (Wednesday, June 14, 2023)]
[Rules and Regulations]
[Pages 38748-38749]
[FR Doc No: 2023-12652]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2023-0413]

Safety Zone; Annual Fireworks Displays and Other Events in the
Eighth Coast Guard District Requiring Safety Zones--Go 4th New Orleans
Independence Day Celebration

AGENCY: Coast Guard, DHS.

ACTION: Notification of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce a temporary safety zone for the
Go 4th New Orleans Independence Day Celebration fireworks display
located on the navigable waters of the Lower Mississippi River between
mile marker (MM) 94.3 and MM 95.3. This action is needed to provide for
the safety of life on these navigable waterways during this event.
During the enforcement periods, entry into this zone is prohibited
unless authorized by the Captain of the Port or a designated
representative. Persons or vessels desiring to enter into or passage
through the zone must request permission from the Captain of the Port
or a designated representative. If permission is granted, all persons
and vessels shall comply with the instructions of the Captain of the
Port or designated representative. Designated representatives include
commissioned, warrant, and petty officers of the U.S. Coast Guard.

DATES: The regulations in 33 CFR part 165.801, Table 5, line 3 will be
enforced from 8:30 through 9:30 p.m. on July 4, 2023.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notification of enforcement, call or email Lieutenant Commander William
Stewart, Sector New Orleans, U.S. Coast Guard; telephone<PHONE_NUMBER>,
email [email protected].

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce a temporary
safety zone in 33 CFR 165.801, Table 5, line 3, for the Go 4th New
Orleans Independence Day Celebration fireworks display event. This
regulation will be enforced from 8:30 through 9:30 p.m. on July 4,
2023. This action is being taken to provide for the safety of life on
these navigable waterways during this event. Our regulation for annual
fireworks displays and other events in the Eighth Coast Guard District
requiring safety zones, 33 CFR 165.801, Table 5, line 3 specifies the
location of the safety zone on the Lower Mississippi River, between
mile marker (MM) 94.3 and MM 95.3. During the enforcement period, entry
into this zone is prohibited unless authorized by the Captain of the
Port or a designated representative. Persons or vessels desiring to
enter into or passage through the zone must request permission from the
Captain of the Port or a designated representative. If permission is
granted, all persons and vessels shall comply with the instructions of
the Captain of the Port or designated representative. Designated
representatives include commissioned, warrant, and petty officers of
the U.S. Coast Guard.
    In addition to this notification of enforcement in the Federal
Register, the Coast Guard plans to provide

notification of this enforcement period via a Marine Safety Information
Bulletin and/or Broadcast Notice to Mariners.

    Dated: May 25, 2023.
K.K. Denning,
Captain, U.S. Coast Guard, Captain of the Port Sector New Orleans.
[FR Doc. 2023-12652 Filed 6-13-23; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 49 (Tuesday, March 13, 2012)]
[Notices]
[Pages 14771-14772]
[FR Doc No: 2012-5974]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP12-78-000]

UGI Storage Company; Notice of Application

    Take notice that on February 29, 2012, UGI Storage Company (UGI
Storage), having its principal place of business at 5665 Leesport
Avenue, Reading, PA 19605, filed an application in Docket No. CP12-78-
000 pursuant to section 7(c) of the Natural Gas Act (NGA) and Part 157
of the Commission's Regulations, for a certificate of public
convenience and necessity requesting authorization to (1) acquire and
operate certain pipeline facilities from UGI Central Penn Gas, Inc. and
(2) lease a portion of the facilities back to UGI Central Penn Gas,
Inc. for approximately five years. Specifically, UGI Storage requests
authorization to acquire a pipeline segment that originates near the
town of Mansfield in Richmond Township, Tioga County, Pennsylvania and
terminates at an interconnection with the existing system of UGI
Storage

near the town of Wellsboro, Delmar Township, Tioga County,
Pennsylvania, all as more fully set forth in the application, which is
on file with the Commission and open to public inspection. This filing
may also be viewed on the web at http://www.ferc.gov using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, contact FERC at<EMAIL_ADDRESS>or call toll-
free,<PHONE_NUMBER> or TYY,<PHONE_NUMBER>.
    Any questions regarding this application should be directed to
Frank H. Markle, Senior Counsel, UGI Corporation, Box 858, Valley
Forge, PA 19482 by calling<PHONE_NUMBER>, or email:
<EMAIL_ADDRESS>    Pursuant to section 157.9 of the Commission's regulations, 18 CFR
157.9, within 90 days of this Notice, the Commission's staff will
either complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission's staff issuance of
the EA for this proposal. The filing of the EA in the Commission's
public record for this proceeding or the issuance of a Notice of
Schedule for Environmental Review will serve to notify federal and
state agencies of the timing for the completion of all necessary
reviews, and the subsequent need to reach a final decision on a request
for federal authorization within 90 days of the date of issuance of the
Commission staff's EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
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. See, 18 CFR 385.2001(a)(1)(iii) and the instructions on the
Commission's Web site under the ``e-Filing'' link.
    Comment Date: March 27, 2012.

    Dated: March 6, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-5974 Filed 3-12-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 71 (Monday, April 13, 2020)]
[Notices]
[Pages 20565-20566]
[FR Doc No: 2020-07680]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2020-0007]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of denials.

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SUMMARY: FMCSA announces its decision to deny applications from 51
individuals who requested an exemption from the vision standard in the
Federal Motor Carrier Safety Regulations (FMCSRs) to operate a CMV in
interstate commerce.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
ET, Monday through Friday, except Federal holidays. If you have
questions regarding viewing materials in the docket, contact Docket
Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov/docket?D=FMCSA-2020-0007 and choose the document to review. If you do
not have access to the internet, you may view the docket online by
visiting the Docket Operations in Room W12-140 on the ground floor of
the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590,
between 9 a.m. and 5 p.m., ET, Monday through Friday, except Federal
holidays. To be sure someone is there to help you, please call (202)
366-9317 or<PHONE_NUMBER> before visiting Docket Operations.

B. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.transportation.gov/privacy.

II. Background

    FMCSA received applications from 51 individuals who requested an
exemption from the vision standard in the FMCSRs.
    FMCSA has evaluated the eligibility of these applicants and
concluded that granting these exemptions would not provide a level of
safety that would be equivalent to, or greater than, the level of
safety that would be obtained by complying with Sec.  391.41(b)(10).

III. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption. FMCSA grants exemptions from the FMCSRs for a 2-year period
to align with the maximum duration of a driver's medical certification.
    The Agency's decision regarding these exemption applications is
based on medical reports about the applicants' vision, as well as their
driving records and experience driving with the vision deficiency.

IV. Conclusion

    The Agency has determined that these applicants do not satisfy the
eligibility criteria or meet the terms and conditions of the Federal
exemption and granting these exemptions would not provide a level of
safety that would be equivalent to, or greater than, the level of
safety that would be obtained by complying with Sec.  391.41(b)(10).
Therefore, the 51 applicants in this notice have been denied exemptions
from the physical qualification standards in Sec.  391.41(b)(10).
    Each applicant has, prior to this notice, received a letter of
final disposition regarding his/her exemption request. Those decision
letters fully outlined the basis for the denial and constitute final
action by the Agency. This notice summarizes the Agency's recent
denials as required under 49 U.S.C. 31315(b)(4) by periodically
publishing names and reasons for denial.
    The following two applicants did not have sufficient driving
experience over the past three years under normal highway operating
conditions:

Eddie M. Riddle (OH); and James Morris (WV)

    The following 12 applicants had no experience operating a CMV:

David L. Prince (WV)
Zackery R. Burtch (OR)

Monesia Moore (NC)
Andrew I. Hogue (IN)
Sathe M. Hussein (MN)
Dustin T. Thompson (OH)
Logan W. Smith (TN)
Doc G. Madison (MI)
Morgan G. Kent (TX)
Daniel J. Jones (GA)
Evan J. Lambert (OH)
Joshua T. Hensley (KY)

    The following six applicants did not have 3 years of experience
driving a CMV on public highways with their vision deficiencies:

Curtis W. Hall (CT)
Steven T. Robinson (KY)
Timothy G. O'Shea (FL)
Jesus I. Gonzalez Gonzalez (IN)
Thomas A. Robinson (OH)
Luther B. Francois (NY)

    The following three applicants did not have 3 years of recent
experience driving a CMV on public highways with their vision
deficiencies:

William C. Kelley (WI); Nathaniel L. Pittman (NC); and Jose O. Diaz
Rosado (PA)

    The following five applicants did not have sufficient driving
experience over the past 3 years under normal highway operating
conditions (gaps in driving record):

Mark A. Richardson (MD)
Mark Patricola (NJ)
Jamison W. Gourley (OH)
Jacob L. Boyer (MN)
Gregory J. Kuhn (NE)

    The following applicant does not have verifiable proof of
commercial driving experience over the past 3 years under normal
highway operating conditions that would serve as an adequate predictor
of future safe performance:

Irving Ibarez (IL)

    The following 14 applicants were denied for multiple reasons:

William G. Gamble (IN)
Carlos E. Donahue (AR)
Todd A. Wasily (IN)
Blake V. Brooks (SD)
Anges R. Schultz (TX)
John C. Frye (PA)
Adam M. Frakes (KY)
Andy Fernandez (FL)
Mesha L. Rue (NM)
George R. Miller (PA)
Christopher A. Baxter (IL)
Benjamin J. Pasqualone (PA)
Reymondo Garcia (NV)
Robert E. Anglin (OH)

    The following eight applicants drove interstate while restricted to
intrastate driving:

Johnny Watson (GA)
Mike N. Uwainat (IL)
Henry E. Brown (IL)
Edgar Ramirez (NY)
Otis L. Tate (FL)
Carl R. Wakefield (WA)
Frederick A. Brown (DC)
Adriano De Vargas (MD)

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2020-07680 Filed 4-10-20; 8:45 am]
 BILLING CODE 4910-EX-P