[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)]
[Rules and Regulations]
[Pages 45736-45740]
[FR Doc No: 2017-21112]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 261

[EPA-R06-RCRA-2017-0254; FRL-9968-61-Region 6]

Hazardous Waste Management System; Identification and Listing of
Hazardous Waste

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is granting a
petition submitted by Samsung Austin Semiconductor (Samsung) to exclude
from hazardous waste control (or delist) a certain solid waste. This
final rule responds to the petition submitted by Samsung to have the
copper filter cake from the electroplating process excluded, or
delisted from the definition of a hazardous waste. The Copper filter
cake is listed as F006, wastewater treatment sludges from
electroplating operations. The basis of the listing is cadmium,
hexavalent chromium, nickel, and cyanide (complexed). After careful
analysis and evaluation of comments submitted by the public, the EPA
has concluded that the petitioned wastes are not hazardous waste when
disposed of in Subtitle D landfills. This exclusion applies to the
copper filter cake generated at Samsung Austin Semiconductor's Austin,
Texas facility. Accordingly, this final rule excludes the petitioned
waste from the requirements of hazardous waste regulations under the
Resource Conservation and Recovery Act (RCRA) when disposed of in
Subtitle D landfills, but imposes testing conditions to ensure that the
future-generated wastes remain qualified for delisting.

DATES: This final rule is effective on October 2, 2017.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R06-RCRA-2017-0254. All documents in the docket are
listed on the http://www.regulations.gov Web site. 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, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available electronically
through http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: For technical information regarding
the Samsung Austin Semiconductor petition, contact Michelle Peace at
214-665-7430 or by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The information in this section is organized
as follows:

I. Overview Information
    A. What action is EPA finalizing?
    B. Why is EPA approving this delisting?
    C. What are the limits of this exclusion?
    D. How will Samsung Austin Semiconductor manage the waste if it
is delisted?
    E. When is the final delisting exclusion effective?
    F. How does this final rule affect states?
II. Background
    A. What is a ``delisting''?
    B. What regulations allow facilities to delist a waste?
    C. What information must the generator supply?
III. EPA's Evaluation of the Waste Data
    A. What waste and how much did Samsung Austin Semiconductor
petition EPA to delist?
    B. How did Samsung Austin Semiconductor sample and analyze the
waste data in this petition?
IV. Public Comments Received on the Proposed Exclusion
    Who submitted comments on the proposed rule?
V. Statutory and Executive Order Reviews

I. Overview Information

A. What action is EPA finalizing?

    The EPA is finalizing:
    (1) The decision to grant Samsung Austin Semiconductor's petition
to have its copper filter cake excluded, or delisted, from the
definition of a hazardous waste, subject to certain continued
verification and monitoring conditions; and
    (2) To use the Delisting Risk Assessment Software v.3.0.35 to
evaluate the potential impact of the petitioned waste on human health
and the environment. The Agency used this model to predict the
concentration of hazardous constituents released from the petitioned
waste, once it is disposed.
    After evaluating the petition, EPA proposed a rule, on July 14,
2017, to exclude the Samsung Austin Semiconductor copper filter cake
waste from the lists of hazardous wastes under Sec. Sec.  261.31 and
261.32. There were no comments received on this rulemaking.

B. Why is EPA approving this delisting?

    Samsung's petition requests an exclusion from the F006 waste
listing pursuant to 40 CFR 260.20 and 260.22. Samsung does not believe
that the petitioned waste meets the criteria for which EPA listed it.
Samsung also believes no additional constituents or factors could cause
the waste to be hazardous. 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 40 CFR
260.22 (d)(1)-(4) (hereinafter all sectional references are to 40 CFR
unless otherwise indicated). In making the initial delisting
determination, EPA evaluated the petitioned waste against the listing
criteria and factors cited in Sec.  261.11(a)(2) and (3). Based on this
review, EPA agrees with the petitioner that the waste is non-hazardous,
with respect to the original listing criteria. If EPA had found, based
on this review, that the waste remained hazardous based on the factors
for which the waste was originally listed, EPA would have proposed to
deny the petition. 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. 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. EPA believes that the petitioned waste does not meet the
listing criteria and thus should not be a listed waste. EPA's proposed
decision to delist waste from Samsung is based on the information
submitted in support of this rule, including descriptions of the wastes
and analytical data from the Austin, Texas facility.

C. What are the limits of this exclusion?

    This exclusion applies to the waste described in the petition only
if the requirements described in Table 1 of part 261, appendix IX and
the conditions contained herein are satisfied. The conditional
exclusion applies to 750 cubic yards of copper filter cake sludge
generated annually from the Samsung Austin Semiconductor facility in
Austin, TX.

D. How will Samsung Austin Semiconductor manage the waste if it is
delisted?

    Storage containers of the copper filter cake will be transported to
an

authorized, solid waste landfill (e.g., RCRA Subtitle D landfill,
commercial/industrial solid waste landfill, etc.) for disposal. Any
plans for recycling must be addressed through the Hazardous Waste
Recycling regulations.

E. When is the final delisting exclusion effective?

    This rule is effective October 2, 2017. The Hazardous and Solid
Waste Amendments of 1984 amended section 3010 of RCRA to allow rules to
become effective in less than six months when the regulated community
does not need the six-month period to come into compliance. That is the
case here because this rule reduces, rather than increases, the
existing requirements for persons generating hazardous wastes. These
reasons also provide a basis for making this rule effective
immediately, upon publication, under the Administrative Procedure Act,
pursuant to 5 U.S.C. 553(d).

F. How does this final rule affect states?

    Because EPA is issuing this exclusion under the Federal RCRA
delisting program, only states subject to Federal RCRA delisting
provisions would be affected. This would exclude two categories of
States: States having a dual system that includes Federal RCRA
requirements and their own requirements, and States who have received
our authorization to make their own delisting decisions.
    Here are the details: We allow states to impose their own non-RCRA
regulatory requirements that are more stringent than EPA's, under
section 3009 of RCRA. These more stringent requirements may include a
provision that prohibits a Federally issued exclusion from taking
effect in the State. Because a dual system (that is, both Federal
(RCRA) and State (non-RCRA) programs) may regulate a petitioner's
waste, we urge petitioners to contact the State regulatory authority to
establish the status of their wastes under the State law.
    EPA has also authorized some States (for example, Louisiana,
Georgia, Illinois) 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 authorized States. If Samsung
Austin Semiconductor transports the petitioned waste to or manages the
waste in any State with delisting authorization, Samsung Austin
Semiconductor must obtain delisting authorization from that State
before they can manage the waste as nonhazardous in the State.

II. Background

A. What is a delisting?

    A delisting petition is a request from a generator to EPA or
another agency with jurisdiction to exclude from the list of hazardous
wastes, wastes the generator does not consider hazardous under RCRA.

B. What regulations allow facilities to delist a waste?

    Under 40 CFR 260.20 and 260.22, facilities may petition the EPA to
remove their wastes from hazardous waste control by excluding them from
the lists of hazardous wastes contained in Sec. Sec.  261.31 and
261.32. Specifically, Sec.  260.20 allows any person to petition the
Administrator to modify or revoke any provision of parts 260 through
266, 268 and 273 of title 40 of the Code of Federal Regulations.
Section 260.22 provides generators the opportunity to petition the
Administrator to exclude a waste on a ``generator-specific'' basis from
the hazardous waste lists.

C. What information must the generator supply?

    Petitioners must provide sufficient information to EPA to allow the
EPA to determine that the waste to be excluded does not meet any of the
criteria under which the waste was listed as a hazardous waste. In
addition, the Administrator must determine, where he/she has a
reasonable basis to believe that factors (including additional
constituents) other than those for which the waste was listed could
cause the waste to be a hazardous waste, that such factors do not
warrant retaining the waste as a hazardous waste.

III. EPA's Evaluation of the Waste Data

A. What waste and how much did Samsung Austin Semiconductor petition
EPA to delist?

    In November 2015, Samsung petitioned EPA to exclude from the lists
of hazardous wastes contained in Sec. Sec.  261.31 and 261.32, filter
cake (F006) generated from its facility located in Austin, Texas. The
waste falls under the classification of listed waste pursuant to
Sec. Sec.  261.31 and 261.32. Specifically, in its petition, Samsung
requested that EPA grant a conditional exclusion for 750 cubic yards of
F006 filter cake.
    The 40 CFR part 261 appendix VII hazardous constituents which are
the basis for listing can be found in Table 1.

    Table 1--EPA Waste Codes for Copper Filter Cake and the Basis for
                                 Listing
------------------------------------------------------------------------
             Waste code                        Basis for listing
------------------------------------------------------------------------
F006................................  Cadmium, hexavalent chromium,
                                       nickel, cyanide (complexed).
------------------------------------------------------------------------

B. How did Samsung Austin Semiconductor sample and analyze the waste
data in this petition?

    To support its petition, Samsung Austin Semiconductor submitted:
    (1) Historical information on waste generation and management
practices; and
    (2) Analytical results from eight samples for total and TCLP
concentrations of compounds of concern (COC)s;

     Table 2--Analytical Results/Maximum Allowable Delisting Concentration Copper Filter Cake Samsung Austin
                                          Semiconductor, Austin, Texas
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                                                                Maximum total    Maximum  TCLP     Maximum TCLP
                         Constituent                            concentration    concentration   delisting level
                                                                   (mg/kg)           (mg/L)           (mg/L)
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Acetone......................................................           0.0013             0.24           2070.0
Arsenic......................................................              3.6            0.098             1.66
Barium.......................................................             5.30             0.13            100.0
Cadmium......................................................             0.75            0.004            0.362
Carbon disulfide.............................................              2.7            0.043           224.75
Chromium.....................................................               42             0.12              5.0
Chromium(VI) (+6)............................................              1.7            0.072              5.0
Cobalt.......................................................              1.6            0.035             1.36
Copper.......................................................            14600              5.4             97.1

Lead.........................................................              6.3             0.11             2.45
Nickel.......................................................             25.7            0.078             53.8
Selenium.....................................................              1.4            0.072              1.0
Silver.......................................................             0.95           0.0012              5.0
Thallium.....................................................              1.7               ND           0.1458
Tin..........................................................              7.6               ND             22.5
Toluene......................................................              2.5               ND             60.1
Vanadium.....................................................             25.8            0.014            14.36
Zinc.........................................................             43.0             0.21              797
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Notes: These levels represent the highest constituent concentration found in any one sample and does not
  necessarily represent the specific level found in one sample.

IV. Public Comments Received on the Proposed Exclusion

Who submitted comments on the proposed rule?

    The EPA received no public comments on the July 14, 2017, proposed
rule.

V. Statutory and Executive Order Reviews

    Under Executive Order 12866, ``Regulatory Planning and Review'' (58
FR 51735, October 4, 1993), this rule is not of general applicability
and therefore, is not a regulatory action subject to review by the
Office of Management and Budget (OMB). This rule 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 applies to a
particular facility only. Because this rule is of particular
applicability relating to a particular facility, it is not subject to
the regulatory flexibility provisions of the Regulatory Flexibility Act
(5 U.S.C. 601 et seq.), or to sections 202, 204, and 205 of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Because
this rule will affect only a particular facility, it will not
significantly or uniquely affect small governments, as specified in
section 203 of UMRA. Because this rule will affect only a particular
facility, this rule does not have federalism implications. It will not
have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132, ``Federalism'', (64 FR 43255,
August 10, 1999). Thus, Executive Order 13132 does not apply to this
rule.
    Similarly, because this rule will affect only a particular
facility, this rule does not have tribal implications, as specified in
Executive Order 13175, ``Consultation and Coordination with Indian
Tribal Governments'' (65 FR 67249, November 9, 2000). Thus, Executive
Order 13175 does not apply to this rule. This rule also is not subject
to Executive Order 13045, ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997), because
it is not economically significant as defined in Executive Order 12866,
and because the Agency does not have reason to believe the
environmental health or safety risks addressed by this action present a
disproportionate risk to children. The basis for this belief is that
the Agency used DRAS, which considers health and safety risks to
children, to calculate the maximum allowable concentrations for this
rule. This rule is not subject to Executive Order 13211, ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use'' (66 FR 28355 (May 22, 2001)), because it is not
a significant regulatory action under Executive Order 12866. This rule
does not involve technical standards; thus, the requirements of section
12(d) of the National Technology Transfer and Advancement Act of 1995
(15 U.S.C. 272 note) do not apply. As required by section 3 of
Executive Order 12988, ``Civil Justice Reform'', (61 FR 4729, February
7, 1996), in issuing this rule, EPA has taken the necessary steps to
eliminate drafting errors and ambiguity, minimize potential litigation,
and provide a clear legal standard for affected conduct.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report which includes a copy of the rule to
each House of the Congress and to the Comptroller General of the United
States. Section 804 exempts from section 801 the following types of
rules: (1) Rules of particular applicability; (2) rules relating to
agency management or personnel; and (3) rules of agency organization,
procedure, or practice that do not substantially affect the rights or
obligations of non-agency parties (5 U.S.C. 804(3)). EPA is not
required to submit a rule report regarding today's action under section
801 because this is a rule of particular applicability. Executive Order
(E.O.) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes Federal executive
policy on environmental justice. Its main provision directs Federal
agencies, to the greatest extent practicable and permitted by law, to
make environmental justice part of their mission by identifying and
addressing, as appropriate, disproportionately high and adverse human
health or environmental effects of their programs, policies, and
activities on minority populations and low-income populations in the
United States.
    EPA has determined that this rule will not have disproportionately
high and adverse human health or environmental effects on minority or
low-income populations because it does not affect the level of
protection provided to human health or the environment. The Agency's
risk assessment 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, EPA
believes that any populations in proximity of the landfills used by
this facility should not be adversely affected by common waste
management practices for this delisted waste.

List of Subjects in 40 CFR Part 261

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

    Authority:  Sec. 3001(f) RCRA, 42 U.S.C. 6921(f).

    Dated: September 19, 2017.
Wren Stenger,
Director, Multimedia Division, Region 6.

    For the reasons set out in the preamble, 40 CFR part 261 is amended
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. In table 1 of appendix IX to part 261 add the entry ``Samsung'' 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
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           Facility                        Address                             Waste description
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Samsung.......................  Austin, TX...................  Copper Filter Cake (EPA Hazardous Waste Numbers
                                                                F006) generated at a maximum rate of 750 cubic
                                                                yards annually.
                                                               For the exclusion to be valid, Samsung must
                                                                implement a verification testing program for
                                                                each of the waste streams that meets the
                                                                following Paragraphs:
                                                               (1) Delisting Levels:
                                                                  All concentrations for those constituents must
                                                                   not exceed the maximum allowable
                                                                   concentrations in mg/l specified in this
                                                                   paragraph.
                                                               Copper Filter Cake. Leachable Concentrations (mg/
                                                                l): Acetone--2070.0; Arsenic--1.66; Barium--
                                                                100.0; Cadmium--0.362; Carbon Disulfide--224.75;
                                                                Chromium--5.0; Chromium (VI)--5.0; Cobalt--1.36;
                                                                Copper--97.1; Lead--2.45; Nickel--53.8;
                                                                Selenium--1.0; Silver--5.0; Thallium--0.01458;
                                                                Tin--22.5; Toluene--60.1; Vanadium--14.36; Zinc--
                                                                797
                                                               (2) Waste Holding and Handling:
                                                                  (A) Waste classification as non-hazardous
                                                                   cannot begin until compliance with the limits
                                                                   set in paragraph (1) for the Copper Filter
                                                                   cake is verified.
                                                                  (B) If constituent levels in any sample and
                                                                   retest sample taken by Samsung exceed any of
                                                                   the delisting levels set in paragraph (1) for
                                                                   the Copper Filter cake, Samsung must do the
                                                                   following:
                                                                    (i) notify EPA in accordance with paragraph
                                                                     (5) and
                                                                    (ii) manage and dispose the Copper Filter
                                                                     cake as hazardous waste generated under
                                                                     Subtitle C of RCRA.
                                                               (3) Testing Requirements:
                                                                  Samsung must perform analytical testing by
                                                                   sampling and analyzing the Copper Filter cake
                                                                   as follows:
                                                                    (i) Collect a representative sample of the
                                                                     Copper Filter cake for analysis of all
                                                                     constituents listed in paragraph (1) prior
                                                                     to disposal.
                                                                    (ii) The samples for the annual testing
                                                                     shall be a representative sample, according
                                                                     to appropriate methods. As applicable to
                                                                     the method-defined parameters of concern,
                                                                     analyses requiring the use of SW-846
                                                                     methods incorporated by reference in 40 CFR
                                                                     260.11 must be used without substitution.
                                                                     As applicable, the SW-846 methods might
                                                                     include Methods 0010, 0011, 0020, 0023A,
                                                                     0030, 0031, 0040, 0050, 0051, 0060, 0061,
                                                                     1010A, 1020B,1110A, 1310B, 1311, 1312,
                                                                     1320, 1330A, 9010C, 9012B, 9040C, 9045D,
                                                                     9060A, 9070A (uses EPA Method 1664, Rev.
                                                                     A), 9071B, and 9095B. Methods must meet
                                                                     Performance Based Measurement System
                                                                     Criteria in which the Data Quality
                                                                     Objectives are to demonstrate that samples
                                                                     of the Samsung Copper filter cake is
                                                                     representative for all constituents listed
                                                                     in paragraph (1).
                                                               (4) Data Submittals:
                                                                  Samsung must submit the information described
                                                                   below. If Samsung fails to submit the
                                                                   required data within the specified time or
                                                                   maintain the required records on-site for the
                                                                   specified time, EPA, at its discretion, will
                                                                   consider this sufficient basis to reopen the
                                                                   exclusion as described in paragraph (6).
                                                                   Samsung must:
                                                                  (A) Submit the data obtained through paragraph
                                                                   3 to the Section Chief, 6MM-RP, Multimedia
                                                                   Division, U.S. Environmental Protection
                                                                   Agency Region 6, 1445 Ross Ave., Suite 1200,
                                                                   Dallas, Texas 75202, within the time
                                                                   specified. All supporting data can be
                                                                   submitted on CD-ROM or comparable electronic
                                                                   media.
                                                                  (B) Compile records of analytical data from
                                                                   paragraph (3), summarized, and maintained on-
                                                                   site for a minimum of five years.
                                                                  (C) Furnish these records and data when either
                                                                   EPA or the State of Texas requests 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
                                                                   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 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.''
                                                               (5) Reopener:
                                                                  (A) If any time after disposal of the delisted
                                                                   waste Samsung possesses or is otherwise made
                                                                   aware of any environmental data (including
                                                                   but not limited to underflow water 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 either the verification testing (and
                                                                   retest, if applicable) of the waste does not
                                                                   meet the delisting requirements in paragraph
                                                                   1, Samsung 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 Samsung 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 and/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 requires action by
                                                                   EPA, 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
                                                                   days from receipt 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 EPA actions that are necessary to
                                                                   protect human health and/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:
                                                                  Samsung 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 it will transport the delisted
                                                                   waste described above for disposal, 60 days
                                                                   before beginning such activities.
                                                                  (B) For onsite disposal, a notice should be
                                                                   submitted to the State to notify the State
                                                                   that disposal of the delisted materials has
                                                                   begun.
                                                                  (C) Update one-time written notification, if
                                                                   it ships the delisted waste into a different
                                                                   disposal facility.
                                                                  (D) Failure to provide this notification will
                                                                   result in a violation of the delisting
                                                                   exclusion and a possible revocation of the
                                                                   decision.

                                                  * * * * * * *
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* * * * *
[FR Doc. 2017-21112 Filed 9-29-17; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 26 (Tuesday, February 8, 2022)]
[Notices]
[Pages 7197-7198]
[FR Doc No: 2022-02568]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2022-0048]

Information Collection Request to Office of Management and
Budget; OMB Control Number: 1625-0039

AGENCY: Coast Guard, DHS.

ACTION: Sixty-day notice requesting comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an Information Collection Request
(ICR) to the Office of Management and Budget (OMB), Office of
Information and Regulatory Affairs (OIRA), requesting an extension of
its approval for the following collection of information: 1625-0039,
Declaration of Inspection Before Transfer of Liquid Cargo in Bulk;
without change. Our ICR describes the information we seek to collect
from the public. Before submitting this ICR to OIRA, the Coast Guard is
inviting comments as described below.

DATES: Comments must reach the Coast Guard on or before April 11, 2022.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2022-0048] to the Coast Guard using the Federal
eRulemaking Portal at https://www.regulations.gov. See the ``Public
participation and request for comments'' portion of the SUPPLEMENTARY
INFORMATION section for further instructions on submitting comments.
    A copy of the ICR is available through the docket on the internet
at https://www.regulations.gov. Additionally, copies are available
from: Commandant (CG-6P), ATTN: Paperwork Reduction Act Manager, U.S.
Coast Guard, 2703 Martin Luther King Jr. Ave. SE, STOP 7710,
Washington, DC 20593-7710.

FOR FURTHER INFORMATION CONTACT: A.L. Craig, Office of Privacy
Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>, for questions
on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. 3501 et seq., chapter 35, as amended. An ICR is an
application to OIRA seeking the approval, extension, or renewal of a
Coast Guard collection of information (Collection). The ICR contains
information describing the Collection's purpose, the Collection's
likely burden on the affected public, an explanation of the necessity
of the Collection, and other important information describing the
Collection. There is one ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology.
    In response to your comments, we may revise this ICR or decide not
to seek

an extension of approval for the Collection. We will consider all
comments and material received during the comment period.
    We encourage you to respond to this request by submitting comments
and related materials. Comments must contain the OMB Control Number of
the ICR and the docket number of this request, [USCG-2022-0048], and
must be received by April 11, 2022.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at https://www.regulations.gov. If your material cannot be
submitted using https://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at https://www.regulations.gov and
can be viewed by following that website's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted
without change to https://www.regulations.gov and will include any
personal information you have provided. For more about privacy and
submissions in response to this document, see DHS's eRulemaking System
of Records notice (85 FR 14226, March 11, 2020).

Information Collection Request

    Title: Declaration of Inspection Before Transfer of Liquid Cargo in
Bulk.
    OMB Control Number: 1625-0039.
    Summary: A Declaration of Inspection (DOI) documents the transfer
of oil and hazardous materials, to help prevent spills and damage to a
facility or vessel. Persons-in-charge of the transfer operations must
review and certify compliance with procedures specified by the terms of
the DOI.
    Need: 46 U.S.C. 3703 authorizes the Secretary of the Department of
Homeland Security (DHS) to establish regulations to prevent the
discharge of oil and hazardous material from vessels and facilities.
This authority is delegated by the Secretary to the Coast Guard via the
Department of Homeland Security Delegation No. 0170.1, Revision No.
01.2. (II)(92.b).The DOI regulations appear at 33 CFR 156.150 and 46
CFR 35.35-30.
    Forms: None.
    Respondents: Persons-in-charge of transfers.
    Frequency: On occasion.
    Hour Burden Estimate: The estimated burden remains 80,051 hours a
year.
    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. chapter
35, as amended.

    Dated: February 1, 2022.
Kathleen Claffie,
Chief, Office of Privacy Management, U.S. Coast Guard.
[FR Doc. 2022-02568 Filed 2-7-22; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 88, Number 248 (Thursday, December 28, 2023)]
[Notices]
[Pages 89706-89707]
[FR Doc No: 2023-28595]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-4177]

Quality Considerations for Topical Ophthalmic Drug Products;
Revised Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a revised draft guidance for industry entitled
``Quality Considerations for Topical Ophthalmic Drug Products.'' This
revised draft guidance discusses certain quality considerations for
ophthalmic drug products (i.e., gels, ointments, creams, and liquid
formulations such as solutions, suspensions, and emulsions) intended
for topical delivery in and around the eye. Specifically, this revised
draft guidance discusses microbiological considerations; approaches to
evaluating visible particulate matter, extractables and leachables, and
impurities and degradation products; use of in vitro drug release/
dissolution testing as an optional quality control strategy for certain
ophthalmic dosage forms; recommendations for design and delivery and
dispensing features of container closure systems; and recommendations
for stability studies. The revised draft guidance applies to marketed
products including ophthalmic drug products approved under new drug
applications (NDAs), abbreviated new drug applications (ANDAs), and
biologics license applications (BLAs), as well as to over-the-counter
(OTC) monograph drugs, drugs compounded by outsourcing facilities, and
the drug or biological product constituent part of a combination
product. This guidance revises the draft guidance for industry of the
same name issued in October 2023.

DATES: Submit either electronic or written comments on the revised
draft guidance by February 26, 2024 to ensure that the Agency considers
your comment on this revised draft guidance before it begins work on
the final version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-D-4177 for ``Quality Considerations for Topical Ophthalmic
Drug Products.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the revised draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993-0002. Send one self-addressed adhesive label to assist that
office in processing your requests. See the SUPPLEMENTARY INFORMATION
section for electronic access to the revised draft guidance document.

FOR FURTHER INFORMATION CONTACT: Ranjani Prabhakara, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 6648, Silver Spring, MD 20993-0002, 240-
402-4652.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft guidance for
industry entitled ``Quality Considerations for Topical Ophthalmic Drug
Products.'' This revised draft guidance provides information regarding
quality considerations for ophthalmic drug products consistent with the
requirements outlined in section 501(a)(2)(B) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351(a)(2)(B)) and 21 CFR
parts 210 and 211 for all drug products, 21 CFR part 601 for biological
products, 21 CFR part 4 for combination products, and, for ophthalmic
drug products with a U.S. Pharmacopeia (USP) monograph, the applicable
criteria from the USP. The revised draft guidance also provides
recommendations to industry on the documentation that should be
submitted in the chemistry, manufacturing, and controls (CMC) section
of NDAs, ANDAs, and BLAs for certain CMC attributes for ophthalmic drug
products.
    This revised draft guidance revises the guidance of the same name
published on October 13, 2023 (88 FR 70997). FDA is revising this draft
guidance to address microbiological considerations related to product
sterility for all ophthalmic drug products subject to current good
manufacturing practice (CGMP) requirements and the prevention of
contamination of ophthalmic drug products packaged in multidose
containers, given several recent recalls of ophthalmic drug products
and instances of consumer injury and death from microbiologically
contaminated ophthalmic drug products.
    FDA is also revising the draft guidance to clarify its stated
scope. As originally published, the scope explicitly included NDA,
ANDA, and BLA products regulated by the Center for Drug Evaluation and
Research; OTC monograph drugs marketed under section 505G of the FD&C
Act (21 U.S.C. 355h); and combination products. It was not FDA's
intention to specifically exclude products that are not marketed under
an approved application or under section 505G of the FD&C Act; however,
the draft guidance may have been interpreted that way. Therefore, FDA
is clarifying that the guidance also applies to other drugs that, while
also subject to CGMP requirements, are not marketed under a drug
application, including drugs compounded by outsourcing facilities
pursuant to section 503B of the FD&C Act (21 U.S.C. 353b).
    This revised draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The revised draft
guidance, when finalized, will represent the current thinking of FDA on
``Quality Considerations for Topical Ophthalmic Drug Products.'' It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Previous Submission of Comments

    In commenting on this revised draft guidance, you do not need to
reiterate comments that you previously submitted regarding the draft
guidance issued on October 13, 2023. Your previously submitted comments
will still be considered. You may instead submit updates to previously
submitted comments, as needed, and comments related to the new section
on microbiological considerations and the clarified scope of this
revised draft guidance.

III. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR part 314 for NDAs and ANDAs have been approved under OMB
control number 0910-0001. The collections of information in 21 CFR part
601 for BLAs have been approved under OMB control number 0910-0338. The
collections of information in 21 CFR parts 210 and 211 pertaining to
CGMP have been approved under OMB control number 0910-0139. The
collections of information in 21 CFR 201.56 and 201.57 relating to
certain prescription product labeling requirements have been approved
under OMB control number 0910-0572. The collections of information for
section 351(k) submission of the Public Health Service Act (42 U.S.C.
262(k)) have been approved under OMB control number 0910-0718. The
collections of information pertaining to human drug compounding under
section 503B of the FD&C Act have been approved under OMB control
number 0910-0858.

IV. Electronic Access

    Persons with access to the internet may obtain the revised draft
guidance at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: December 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-28595 Filed 12-27-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 123 (Thursday, June 26, 2014)]
[Proposed Rules]
[Pages 36269-36273]
[FR Doc No: 2014-14850]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

18 CFR Part 40

[Docket No. RM14-7-000]

Modeling, Data, and Analysis Reliability Standards

AGENCY: Federal Energy Regulatory Commission.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: Pursuant to the Federal Power Act, the Commission proposes to
approve Modeling, Data, and Analysis Reliability Standard MOD-001-2
developed by the North American Electric Reliability Corporation, which
the Commission has certified as the Electric Reliability Organization
responsible for developing and enforcing mandatory Reliability
Standards.

DATES: Comments are due August 25, 2014.

ADDRESSES: Comments, identified by docket number, may be filed in the
following ways:
     Electronic Filing through http://www.ferc.gov. Documents
created electronically using word processing software should be filed
in native applications or print-to-PDF format and not in a scanned
format.
     Mail/Hand Delivery: Those unable to file electronically
may mail or hand-deliver comments to: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE.,
Washington, DC 20426.
    Instructions: For detailed instructions on submitting comments and
additional information on the rulemaking process, see the Comment
Procedures Section of this document.

FOR FURTHER INFORMATION CONTACT:

Michael Gandolfo (Technical Information), Office of Electric
Reliability, Federal Energy Regulatory Commission, 888 First Street
NE., Washington, DC 20426, Telephone:<PHONE_NUMBER>,
<EMAIL_ADDRESS>Robert T. Stroh (Legal Information), Office of the General Counsel,
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, Telephone:<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    1. Pursuant to section 215(d) of the Federal Power Act (FPA),\1\
the Commission proposes to approve Reliability Standard MOD-001-2
(Modeling, Data, and Analysis) developed by the North American Electric
Reliability Corporation (NERC), which the Commission has certified as
the Electric Reliability Organization (ERO) responsible for developing
and enforcing mandatory Reliability Standards. Reliability Standard
MOD-001-2 addresses the reliability issues associated with
determinations of available transfer capability (ATC) and available
flowgate capability (AFC). The Commission also proposes to approve the
associated violation risk factors and violation severity levels and
NERC's proposed retirement of the currently effective Reliability
Standards MOD-001-1a, MOD-004-1, MOD-008-1, MOD-028-2, MOD-029-1a, and
MOD-030-2.
---------------------------------------------------------------------------

    \1\ 16 U.S.C. 824o(d) (2012).
---------------------------------------------------------------------------

I. Background

    2. Section 215 of the FPA requires a Commission-certified ERO to
develop mandatory and enforceable Reliability Standards, which are
subject to Commission review and approval. Once approved, the
Reliability Standards are enforced by the ERO, subject to Commission
oversight, or by the Commission independently.

Development of ATC and AFC in Order Nos. 888, 889 and 890

    3. NERC developed the currently-effective Reliability Standards
MOD-001-1a, MOD-004-1, MOD-008-1, MOD-028-2, MOD-029-1a, and MOD-030-2
(Existing MOD A Standards) based on the obligation for transmission
service providers to determine ATC and AFC, as those terms were
introduced in Order Nos. 888 and 889.\2\ Although Order Nos. 888 and
889 obligated each public utility to calculate and post ATC, formal
methods for calculating ATC or AFC did not exist, nor did the
Commission mandate the use of specific methodologies.
---------------------------------------------------------------------------

    \2\ Promoting Wholesale Competition Through Open Access Non-
Discriminatory Transmission Services by Public Utilities; Recovery
of Stranded Costs by Public Utilities and Transmitting Utilities,
Order No. 888, FERC Stats. & Regs. ] 31,036 (1996), order on reh'g,
Order No. 888-A, FERC Stats. & Regs. ] 31,048, order on reh'g, Order
No. 888-B, 81 FERC ] 61,248 (1997), order on reh'g, Order No. 888-C,
82 FERC ] 61,046 (1998), aff'd in relevant part sub nom.
Transmission Access Policy Study Group v. FERC, 225 F.3d 667 (D.C.
Cir. 2000), aff'd sub nom. New York v. FERC, 535 U.S. 1 (2002). Open
Access Same-Time Information System (Formerly Real-Time Information
Networks) and Standards of Conduct, Order No. 889, 61 FR 21737 (May
10, 1996), FERC Stats. & Regs. ] 31,035, at 31,749 (1996), order on
reh'g, Order No. 889-A, FERC Stats. & Regs. ] 31,049, order on
reh'g, Order No. 889-B, 81 FERC ] 61,253 (1997).
---------------------------------------------------------------------------

    4. In February 2007 the Commission issued Order No. 890 and, among
other things, sought to standardize the manner in which ATC/AFC was
calculated.\3\ The Commission also noted that ATC/AFC calculations
raise reliability issues, namely, the need for a transmission provider
to know of its neighbors' system conditions affecting its own ATC
values. As a result of this reliability concern, the Commission found
that the proposed ATC reforms were also supported by FPA section 215,
through which the Commission has the authority to direct the ERO to
submit a Reliability Standard that addresses a specific matter.\4\
Thus, the Commission in Order No. 890 directed the development of
Reliability Standards, using the ERO's Reliability Standards
development process, that provide for consistency and transparency in
the methodologies used by transmission owners to calculate ATC. The
Commission found that, if all of the ATC components and certain data
inputs and certain assumptions are consistent, the ATC calculation
methodologies would produce predictable and sufficiently accurate,
consistent, equivalent and replicable results.\5\
---------------------------------------------------------------------------

    \3\ Preventing Undue Discrimination and Preference in
Transmission Service, Order No. 890, FERC Stats. & Regs. ] 31,241,
at P 68, order on reh'g, Order No. 890-A, FERC Stats. & Regs. ]
31,261 (2007), order on reh'g, Order No. 890-B, 123 FERC ] 61,299
(2008), order on reh'g, Order No. 890-C, 126 FERC ] 61,228, order on
clarification, Order No. 890-D, 129 FERC ] 61,126 (2009).
    \4\ See 16 U.S.C. 824o(d)(5).
    \5\ Order No. 890, FERC Stats. & Regs. ] 31,241 at P 210.
---------------------------------------------------------------------------

Order Nos. 693 and 729

    5. On March 16, 2007, the Commission issued Order No. 693,
approving 83 of the 107 Reliability Standards filed by NERC in April
2006.\6\ Of the 83 approved Reliability Standards, the Commission
approved ten MOD Reliability Standards. In addition, the Commission
directed NERC to prospectively modify nine of the ten approved MOD
Reliability

Standards to be consistent with the requirements of Order No. 890.\7\
In Order No. 693, the Commission reiterated its concerns with respect
to ATC articulated in Order No. 890 and directed NERC and the industry
to develop Reliability Standards that provide for consistency and
transparency in the methodologies used by transmission providers to
calculate ATC.\8\ The Commission directed public utilities, working
through the NERC Reliability Standards and North American Energy
Standards Board (NAESB) business practices development processes, to
produce solutions to implement the ATC-related reforms adopted by the
Commission.
---------------------------------------------------------------------------

    \6\ Mandatory Reliability Standards for the Bulk-Power System,
Order No. 693, FERC Stats. & Regs. ] 31,242, order on reh'g, Order
No. 693-A, 120 FERC ] 61,053 (2007).
    \7\ Order No. 693, FERC Stats. & Regs. ] 31,242 at P 1010.
    \8\ Id. PP 1020-1034.
---------------------------------------------------------------------------

    6. In response to the requirements of Order No. 890 and related
directives of Order No. 693, NERC developed the Existing MOD A
Standards, which the Commission approved in Order No. 729.\9\ The
Existing MOD A Standards standardized the manner in which ATC/AFC is
determined and required the documentation and sharing of ATC/AFC
methodologies. In approving the Existing MOD A Reliability Standards in
Order No. 729, the Commission also directed NERC to modify certain
aspects of those standards.
---------------------------------------------------------------------------

    \9\ Mandatory Reliability Standards for the Calculation of
Available Transfer Capability, Capacity Benefit Margins,
Transmission Reliability Margins, Total Transfer Capability, and
Existing Transmission Commitments and Mandatory Reliability
Standards for the Bulk-Power System, Order No. 729, 129 FERC ]
61,155 (2009), order on clarification, Order No. 729-A, 131 FERC ]
61,109 (2010), order on reh'g, Order No. 729-B, 132 FERC ] 61,027
(2010).
---------------------------------------------------------------------------

II. NERC Petition

    7. NERC states that proposed Reliability Standard MOD-001-2
replaces, consolidates and improves upon the Existing MOD A Standards
by establishing a framework that comprehensively addresses the
reliability concerns raised in Order Nos. 693, 890 and 729. According
to NERC, ATC and AFC values ``are commercial in nature, representing
the amount of unused transmission capacity that a Transmission Service
Provider is willing to make available for sale to third parties. The
purpose of proposed MOD-001-2 is to help ensure that determinations of
ATC and AFC are accomplished in a manner that supports the reliable
operation of the Bulk-Power System.'' \10\ NERC explains that the
consolidation of the reliability-based requirements of the currently-
effective MOD A Standards into a single standard focused exclusively on
requirements necessary to protect reliability ``is consistent with the
ERO's jurisdiction over reliability matters and NERC's primary mission
to develop standards that support the reliability operation of the
Bulk-Power System.''\11\ With regard to other provisions of the
Existing MOD A Standards, NERC recognizes that:
---------------------------------------------------------------------------

    \10\ Petition at 2.
    \11\ Id. at 27.

    Certain of the requirements from the Existing MOD A Standards
that are not included in the proposed Reliability Standard may be
necessary for market or commercial purposes. Accordingly, NERC
formally requested that NAESB, which administers business practice
standards for the electric industry, consider whether any of the
``retired'' requirements are appropriate for incorporation into
NAESB's WEQ Standards to help maintain a non-discriminatory market
for transmission service. NERC understands that NAESB, working
through its business practice development process, is considering
whether to incorporate into its WEQ Standards those elements from
the Existing MOD A Standards, if any, that relate to commercial or
business practices.\12\
---------------------------------------------------------------------------

    \12\ Id.

    8. NERC explains that proposed Reliability Standard MOD-001-2 helps
ensure that: (1) ATC/AFC and total transfer capability and total
flowgate capacity determinations account for system limits and relevant
system conditions; (2) ATC/AFC, total transfer capability, total
flowgate capacity, capacity benefit margin \13\ and transmission
reliability margin \14\ methodologies are documented and available to
any registered entity with a demonstrated reliability need for such
information; (3) the data supporting those determinations are available
to those entities who need such data to conduct their own
determinations; and (4) any entity with a reliability need has a
mechanism for requesting that the transmission service provider or the
transmission operator respond to requests for clarifications regarding
their ATC/AFC, total transfer capability, total flowgate capacity,
capacity benefit margin and transmission reliability margin
methodologies.
---------------------------------------------------------------------------

    \13\ Capacity benefit margin is a component of ATC/AFC and
``represents the amount of transmission capacity that needs to be
set aside for Load Serving Entities (LSEs) to meet certain
generation reliability requirements.'' Petition at 3.
    \14\ Transmission reliability margin is a component of ATC/AFC
and ``represents the amount of transmission transfer capacity that
needs to be set aside to establish margins for system reliability.''
Id.
---------------------------------------------------------------------------

    9. Further, NERC states that the proposed Reliability Standard
addresses the Commission directives in Order No. 729, to the extent
that the directives relate to the reliability requirements retained in
proposed MOD-002-1.\15\ According to NERC, NAESB may consider whether
Commission directives that relate to requirements not retained in the
proposed Reliability Standard are appropriately addressed in its
Wholesale Electric Quadrant (WEQ) Standards.
---------------------------------------------------------------------------

    \15\ Id. at 6, 28-37.
---------------------------------------------------------------------------

    10. NERC proposes six requirements in proposed Reliability Standard
MOD-001-2.\16\ Requirements R1 through R4 require documentation of the
methodologies for determining ATC/AFC, total transfer capability, total
flowgate capacity, capacity benefit margin and transmission reliability
margin, respectively. Requirements R5 and R6 address information and
data sharing. In particular, Requirement R5 requires each transmission
operator and transmission service provider to provide, upon request, a
written response to any request for clarification of its methodologies
described in Requirements R1 through R4. Requirement R6 provides a data
sharing mechanism that allows each transmission operator and
transmission service provider to access the best available data (e.g.,
load forecasts, expected dispatch, planned outages) for use in
methodologies described in in Requirements R1 through R4.
---------------------------------------------------------------------------

    \16\ Proposed Reliability Standard MOD-001-2 is not attached to
the NOPR. The complete text of the Reliability Standard is available
on the Commission's eLibrary document retrieval system in Docket No.
RM14-7-000 and is posted on the ERO's Web site, available at http://www.nerc.com.

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

Implementation Plan

    11. NERC requests that the Commission approve proposed Reliability
Standard MOD-001-2 and the retirement of the Existing MOD A Standards
effective on the first day of the first calendar quarter that is 18
months after the date that the proposed standard is approved by the
Commission.\17\ NERC states that the proposed implementation period
``is intended to provide NAESB sufficient time to include in its WEQ
Standards, prior to the effective date of proposed MOD-001-2 and the
retirement of the Existing MOD A Standards, those requirements from the
Existing MOD A Standards, if any, that relate to commercial or business
practices and are not included in proposed Reliability Standard MOD-
001-2.'' \18\ NERC adds that if NAESB and its members determine that
requirements from the Existing MOD A Standards need to be incorporated
into the WEQ Standards, 18 months will provide NAESB time, working
through its business practice development process, to adopt revised WEQ
Standards and for the Commission to incorporate by reference those
revised WEQ Standards into its regulations. NERC states that if the
proposed implementation period does not provide NAESB sufficient time
to consider the issues, ``NERC is committed to working with NAESB and
Commission staff to address any timing issues.'' \19\ Further, NERC
states that it has requested that NAESB adopt any revised WEQ Standards
to become effective on the same date that the proposed MOD-001-2 and
the retirement of the Existing MOD A Standards will become effective.
---------------------------------------------------------------------------

    \17\ See Petition at 38 and Exhibit B (Implementation Plan) at
1.
    \18\ Id. at 38.
    \19\ Id.
---------------------------------------------------------------------------

III. Discussion

    12. Pursuant to section 215(d)(2) of the FPA, the Commission
proposes to approve Reliability Standard MOD-001-2 as just, reasonable,
not unduly discriminatory or preferential, and in the public interest.
We also propose to approve the associated violation risk factors and
violation severity levels as well as the retirement of the currently-
effective MOD A Standards as requested by NERC.
    13. Proposed Reliability Standard MOD-001-2 appears to adequately
address the Commission concerns and directives in Order Nos. 890, 693
and 729. In addition, it appears that proposed Reliability MOD-001-2
will enhance reliability by imposing mandatory requirements governing
ATC calculations, thereby providing greater transparency to the
methodologies used for the reliability components of the ATC
equation.\20\ We also believe that there is merit in NERC's proposal to
consolidate the reliability-based requirements of the Existing MOD A
Standards into a single standard, while coordinating with NAESB to
develop NAESB WEQ Standards that pertain to the commercial aspects of
ATC calculations. We seek comment on this aspect of NERC's proposal.
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    \20\ See, e.g., Petition at 17, 22, 24, 26, and 30-31.
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    14. With regard to the implementation plan, NERC explains that the
proposed effective date--the first day of the first calendar quarter
that is 18 months after Commission approval--is designed to allow NAESB
to develop related commercial standards that would take effect
concurrently with MOD-001-2. While NERC's implementation schedule
appears reasonable, we are concerned about a potential ``gap'' should
the retirement of the currently-effective MOD A Standards occur prior
to effective date of corresponding NAESB WEQ business practices.
Accordingly, we seek comment from NAESB and others whether 18 months
from the date of Commission approval provides adequate time for NAESB
to develop related business practices associated with ATC calculations
or whether additional time may be appropriate to better assure
synchronization of the effective dates for the proposed Reliability
Standard and related NAESB practices. Further, while NERC states that
it is ``committed to working with NAESB and Commission staff to address
any timing issues,'' \21\ we seek further elaboration on specific
actions NERC could take to assure synchronization of the effective
dates.
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    \21\ Petition at 38.
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IV. Information Collection Statement

    15. The collection of information contained in this Notice of
Proposed Rulemaking is subject to review by the Office of Management
and Budget (OMB) under section 3507(d) of the Paperwork Reduction Act
of 1995.\22\ OMB's regulations require approval of certain information
collection requirements imposed by agency rules.\23\ Upon approval of a
collection(s) of information, OMB will assign an OMB control number and
an expiration date. Respondents subject to the filing requirements of a
rule will not be penalized for failing to respond to these collections
of information unless the collections of information display a valid
OMB control number.
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    \22\ 44 U.S.C. 3507(d) (2012).
    \23\ 5 CFR 1320.11 (2013).
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    16. We solicit comments on the need for this information, whether
the information will have practical utility, the accuracy of the burden
estimates, ways to enhance the quality, utility, and clarity of the
information to be collected or retained, and any suggested methods for
minimizing respondents' burden, including the use of automated
information techniques. Specifically, the Commission asks that any
revised burden or cost estimates submitted by commenters be supported
by sufficient detail to understand how the estimates are generated.
    17. This notice proposes to approve Reliability Standard MOD-001-2
and to retire Reliability Standards MOD-001-1a, MOD-004-1, MOD-008-1,
MOD-028-2, MOD-029-1a, and MOD-030-2. Proposed Reliability Standard
MOD-001-2 will ensure that ATC calculations are determined in a manner
that supports the reliable operation of the Bulk-Power System and that
the methodology and data underlying those determinations are disclosed
to those registered entities that need such information for reliability
purposes.
    Public Reporting Burden: Proposed Reliability Standard MOD-001-2
does not require responsible entities to file information with the
Commission. However, the Reliability Standard requires applicable
entities to develop and maintain certain information, subject to audit
by a regional entity. In particular, transmission owners and
transmission service providers, with the exception of transmission
owners and transmission service providers within the Electric
Reliability Council of Texas (ERCOT), must ``have evidence'' to show
that methodologies of total flowgate capability or total transfer
capability and AFC and ATC, as well as capacity benefit margin and
transmission reliability margin methodologies. Our estimate below
regarding the number of respondents is based on the NERC compliance
registry as of March 26, 2014. According to the NERC compliance
registry, NERC has registered 170 transmission operators (excluding
transmission operators within ERCOT) and 93 transmission service
providers (excluding transmission service providers in ERCOT). However,
under NERC's compliance registration program, entities may be
registered for multiple functions, so these numbers incorporate some
double counting. The number of unique entities responding will be
approximately 186 entities registered as a transmission operator or a
transmission service provider

(excluding transmission operators and transmission service providers in
ERCOT). The Commission estimates the annual reporting burden and cost
as follows:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Annual  number
                                      Number and  type of    of  responses   Total  number   Average  burden and    Total annual  burden     Cost per
                                          respondents             per        of  responses    cost per  response      hours  and total      respondent
                                                              respondent                                                annual cost            \24\
                                     (1)..................             (2)     (1) * (2) =  (4)..................  (3) * (4) = (5)......       (5) / (1)
                                                                                (3)
--------------------------------------------------------------------------------------------------------------------------------------------------------
(One-time) Review and documentation  170 (TOP)............               1             170  20 hrs. and $1192....  3,400 hours and                 $1192
 of methodology for TFC or TTC and                                                                                $202,708.
 TRM.
(One-time) Review and documentation  93 (TSP).............               1              93  20 hrs. and $1192....  1,860 hours and                 $1192
 of methodology for AFC or ATC and                                                                                $110,893.
 CBM.
(On-going) Record retention (of      170 (TOP) + 93 (TSP)                1             186  2 hrs. and $57.90....  372 hours and $10,769          $57.90
 methodology) and requests for data.  \25\.
(On-going) Retirement of             180 (TP) + 492 (LSE)                1            -551  -3 hrs. and -$178.86.  -1,653 hours and -           -$178.86
 Transmission Planner, Load-Serving   + 107 (BA) \26\.                                                              $98,551.86.
 Entity, and Balancing Authority
 applicability.
(On-going) Retirement of non-        170 (TOP) + 93 (TSP).               1            -186  -16 hrs. and -$953.92  -2,976 and -                 -$953.52
 reliability function requirements.                                                                                $177,429.12.
    Total..........................  .....................            -288  ..............  1003, $48,389.02.....
--------------------------------------------------------------------------------------------------------------------------------------------------------

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    \24\ The estimated hourly costs (salary plus benefits) are based
on Bureau of Labor and Statistics (BLS) information (available at
http://bls.gov/oes/current/naics3_221000.htm#17-0000) for an
electrical engineer ($59.62/hour for review and documentation), and
for a file clerk ($28.95/hour for record retention).
    \25\ 170 TOPs and 93 TSPs result in 186 unique and separate
respondents for the record retention requirement.
    \26\ 180 TPs, 492 LSEs, and 107 BAs result in 551 unique and
separate respondents.
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    Title: Mandatory Reliability Standards for the Bulk-Power System:
MOD Reliability Standards.
    Action: Proposed FERC-725L.
    OMB Control No: 1902-0261
    Respondents: Businesses or other for-profit institutions; not-for-
profit institutions.
    Frequency of Responses: One-time and ongoing.
    Necessity of the Information: Reliability Standard MOD-001-2, if
adopted, would implement the Congressional mandate of the Energy Policy
Act of 2005 to develop mandatory and enforceable Reliability Standards
to better ensure the reliability of the nation's Bulk-Power System.
Specifically, the purpose of the proposed Reliability Standard is to
ensure that determinations of ATC are determined in a manner that
supports the reliable operation of the Bulk-Power System and that the
methodology and data underlying those determinations are disclosed to
those registered entities that need such information for reliability
purposes. The proposed Reliability Standard requires entities to
maintain records subject to review by the Commission and NERC to ensure
compliance with the Reliability Standard.
    Internal Review: The Commission has reviewed the requirements
pertaining to the proposed Reliability Standard for the Bulk-Power
System and determined that the proposed requirements are necessary to
meet the statutory provisions of the Energy Policy Act of 2005. These
requirements conform to the Commission's plan for efficient information
collection, communication and management within the energy industry.
The Commission has assured itself, by means of internal review, that
there is specific, objective support for the burden estimates
associated with the information requirements.
    18. Interested persons may obtain information on the reporting
requirements by contacting the following: Federal Energy Regulatory
Commission, 888 First Street NE., Washington, DC 20426 [Attention:
Ellen Brown, Office of the Executive Director, email:
<EMAIL_ADDRESS>phone:<PHONE_NUMBER>, fax:<PHONE_NUMBER>].
    19. Comments concerning the information collections proposed in
this NOPR and the associated burden estimates should be sent to the
Commission in these dockets and may also be sent to the Office of
Management and Budget, Office of Information and Regulatory Affairs
[Attention: Desk Officer for the Federal Energy Regulatory Commission].
For security reasons, comments should be sent by email to OMB at the
following email address<EMAIL_ADDRESS>Please reference
FERC-725Q and the docket numbers of this Notice of Proposed Rulemaking
(Docket No. RM14-7-000) in your submission.

V. Regulatory Flexibility Act Certification

    20. The Regulatory Flexibility Act of 1980 (RFA) \27\ generally
requires a description and analysis of proposed rules that will have
significant economic impact on a substantial number of small entities.
The RFA mandates consideration of regulatory alternatives that
accomplish the stated objectives of a proposed rule and that minimize
any significant economic impact on a substantial number of small
entities. The Small Business Administration's (SBA's) Office of Size
Standards develops the numerical definition of a small business.\28\
The SBA recently revised its size standard for electric utilities
(effective January 22, 2014) to a standard based on the number of
employees, including affiliates (from a standard based on megawatt
hours).\29\ Under SBA's new size standards, generator owners,
distribution providers, and transmission owners likely come under one
of the following categories and associated size thresholds: \30\
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    \27\ 5 U.S.C. 601-612.
    \28\ 13 CFR 121.101 (2013).
    \29\ SBA Final Rule on ``Small Business Size Standards:
Utilities,'' 78 FR 77343 (12/23/2013).
    \30\ 13 CFR 121.201, Sector 22, Utilities.

 Hydroelectric power generation, at 500 employees

 Fossil fuel electric power generation, at 750 employees
 Nuclear power generation, at 750 employees
 Other electric power generation (e.g. solar, wind, geothermal,
and others), at 250 employees
 Electric bulk power transmission and control, at 500 employees
 Electric power distribution, at 1,000 employees.

    21. Based on U.S. economic census data,\31\ the approximate
percentages of small firms in the above categories varies from 24
percent to 94 percent. However, currently the Commission does not have
information on how the economic census data compare with entities
registered with NERC and is unable to estimate the number of small
transmission service providers and transmission operators using the new
SBA definitions. Regardless, the Commission recognizes that the rule
will likely impact small transmission service providers and
transmission operators and estimates the economic impact on each entity
below.
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    \31\ Data and further information are available from SBA
available at http://www.sba.gov/advocacy/849/12162.
---------------------------------------------------------------------------

    22. Proposed Reliability Standard MOD-001-2 will serve to enhance
reliability by imposing mandatory requirements governing total flowgate
capability or total transfer capability and AFC or ATC methodologies,
as well as capacity benefit margin and transmission reliability margin
methodologies, to be used in modeling. The Commission estimates that
each of the small entities to whom proposed Reliability Standard MOD-
001-2 applies will incur one-time compliance costs of $1,192 (i.e. the
cost of drafting methodologies), plus paperwork and record retention
costs of $57.90 (annual ongoing).\32\ Per entity, the total one-time
implementation costs are estimated to be $1,192 (including paperwork
and non-paperwork costs) and the annual ongoing costs are estimated to
be $57.90.
---------------------------------------------------------------------------

    \32\ The one-time paperwork-related implementation cost estimate
is based on a burden of 20 hours at $59.62/hour, and the annual
record-keeping cost estimate is based on a burden of 2 hours at
$28.95/hour. See supra at 21 and P 1 note/39.
---------------------------------------------------------------------------

    23. Furthermore, the removal of applicable entities from the
proposed retirement of Reliability Standards reduces the total burden
on transmission providers, load-serving entities, and balancing
authorities for an annual savings of $238.48 per entity.\33\
Additionally, NERC proposes the retirement of several requirements
because they do not have a reliability purpose for the transmission
operators and transmission service providers. This retirement results
in an annual savings of $1,192.40 per entity. The Commission does not
consider the estimated costs per small entity to have a significant
economic impact on a substantial number of small entities. Accordingly,
the Commission certifies that this NOPR will not have a significant
economic impact on a substantial number of small entities.
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    \33\ $238.48 = $59.62 (hourly review and documentation cost) +
$178.86 (cost per entity due to retirement of applicability of TPs,
LSEs, and BAs.
---------------------------------------------------------------------------

VI. Environmental Analysis

    24. The Commission is required to prepare an Environmental
Assessment or an Environmental Impact Statement for any action that may
have a significant adverse effect on the human environment.\34\ The
Commission has categorically excluded certain actions from this
requirement as not having a significant effect on the human
environment. Included in the exclusion are rules that are clarifying,
corrective, or procedural or that do not substantially change the
effect of the regulations being amended.\35\ The actions proposed
herein fall within this categorical exclusion in the Commission's
regulations.
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    \34\ Regulations Implementing the National Environmental Policy
Act of 1969, Order No. 486, 52 FR 47897 (Dec. 17, 1987), FERC Stats.
& Regs. Regulations Preambles 1986-1990 ] 30,783 (1987).
    \35\ 18 CFR 380.4(a)(2)(ii).
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VII. Comment Procedures

    25. The Commission invites interested persons to submit comments on
the matters and issues proposed in this notice to be adopted, including
any related matters or alternative proposals that commenters may wish
to discuss. Comments are due August 25, 2014. Comments must refer to
Docket No. RM14-7-000, and must include the commenter's name, the
organization they represent, if applicable, and their address in their
comments.
    26. The Commission encourages comments to be filed electronically
via the eFiling link on the Commission's Web site at http://www.ferc.gov. The Commission accepts most standard word processing
formats. Documents created electronically using word processing
software should be filed in native applications or print-to-PDF format
and not in a scanned format. Commenters filing electronically do not
need to make a paper filing.
    27. Commenters that are not able to file comments electronically
must send an original of their comments to: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE.,
Washington, DC 20426.
    28. All comments will be placed in the Commission's public files
and may be viewed, printed, or downloaded remotely as described in the
Document Availability section below. Commenters on this proposal are
not required to serve copies of their comments on other commenters.

VIII. Document Availability

    29. In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
Internet through the Commission's Home Page (http://www.ferc.gov) and
in the Commission's Public Reference Room during normal business hours
(8:30 a.m. to 5:00 p.m. Eastern time) at 888 First Street NE., Room 2A,
Washington DC 20426.
    30. From the Commission's Home Page on the Internet, this
information is available on eLibrary. The full text of this document is
available on eLibrary in PDF and Microsoft Word format for viewing,
printing, and/or downloading. To access this document in eLibrary, type
the docket number excluding the last three digits of this document in
the docket number field.
    31. User assistance is available for eLibrary and the Commission's
Web site during normal business hours from the Commission's Online
Support at<PHONE_NUMBER> (toll free at 1-866-208-3676) or email at
<EMAIL_ADDRESS>or the Public Reference Room at (202) 502-
8371, TTY<PHONE_NUMBER>. Email the Public Reference Room at
<EMAIL_ADDRESS>
    By direction of the Commission.

    Issued: June 19, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-14850 Filed 6-25-14; 8:45 am]
BILLING CODE 6717-01-P