[Federal Register Volume 78, Number 176 (Wednesday, September 11, 2013)]
[Rules and Regulations]
[Pages 55644-55648]
[FR Doc No: 2013-21919]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0381; FRL-9396-9]

Styrene, Copolymers with Acrylic Acid and/or Methacrylic Acid;
Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation revises an exemption from the requirement of a
tolerance for residues of styrene, copolymers with acrylic acid and/or
methacrylic acid, with none and/or one or more of the following
monomers: Acrylamidopropyl methyl sulfonic acid, methallyl sulfonic
acid, 3-sulfopropyl acrylate, 3-sulfopropyl methacrylate, hydroxypropyl
methacrylate, hydroxypropyl acrylate, hydroxyethyl methacrylate, and/or
hydroxyethyl acrylate; and its sodium, potassium, ammonium,
monoethanolamine, and triethanolamine salts; the resulting polymer
having a minimum number average molecular weight (in amu), 1,200 when
used as an inert ingredient in a pesticide chemical formulation to
include the monomer lauryl methacrylate. Toxcel, (7140 Heritage Village
Plaza, Gainesville, VA 20156) on behalf of Akzo Nobel Surface
Chemistry, (909 Mueller Ave., Chattanooga, TN 37406) submitted a
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA),
requesting an exemption from the requirement of a tolerance.

DATES: This regulation is effective September 11, 2013. Objections and
requests for hearings must be received on or before November 12, 2013,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2013-0381. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (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 in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing

Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. Can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2013-0381 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
November 12, 2013. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2013-0381 by one of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of July 19, 2013 (78 FR 43118) (FRL-9392-
9), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C.
346a, announcing the receipt of a pesticide petition ((PP) IN-10551))
filed by Toxcel, (7140 Heritage Village Plaza, Gainesville, VA 20156)
on behalf of Akzo Nobel Surface Chemistry, (909 Mueller Ave.,
Chattanooga, TN 37406). The petition requested that 40 CFR 180.960 be
amended by revising an exemption from the requirement of a tolerance
for residues of styrene, copolymers with acrylic acid and/or
methacrylic acid, with none and/or one or more of the following
monomers: Acrylamidopropyl methyl sulfonic acid, methallyl sulfonic
acid, 3-sulfopropyl acrylate, 3-sulfopropyl methacrylate, hydroxypropyl
methacrylate, hydroxypropyl acrylate, hydroxyethyl methacrylate, and/or
hydroxyethyl acrylate; and its sodium, potassium, ammonium,
monoethanolamine, and triethanolamine salts; the resulting polymer
having a minimum number average molecular weight (in amu), 1,200 to
include the monomer lauryl methacrylate. That notice included a summary
of the petition prepared by the petitioner and solicited comments on
the petitioner's request. The Agency received one comment from a
private citizen who opposed the authorization to sell any pesticide
that leaves a residue on food. The Agency understands the commenter's
concerns and recognizes that some individuals believe that no residue
of pesticides should be allowed. The Agency has a large database which
indicates that compounds of this nature will not cause residues which
exceed the Agency's level of concern. Under the existing legal
framework provided by section 408 of the Federal Food, Drug and
Cosmetic Act (FFDCA) EPA is authorized to establish pesticide
tolerances or exemptions where persons seeking such tolerances or
exemptions have demonstrated that the pesticide meets the safety
standard imposed by the statute.''
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and use in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing an exemption from the
requirement of a tolerance and to ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue . . .'' and
specifies factors EPA is to consider in establishing an exemption.

III. Risk Assessment and Statutory Findings

    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be shown that the risks from aggregate
exposure to pesticide chemical residues under reasonably foreseeable
circumstances will pose no appreciable risks to human health. In order
to determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considers the toxicity of the inert in
conjunction with possible exposure to residues of the inert ingredient
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. If EPA is able to
determine that a finite tolerance is not necessary to ensure that there
is a reasonable certainty that no harm will result from aggregate
exposure to the inert ingredient, an exemption from the requirement of
a tolerance may be established.
    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. In the case of certain chemical substances that
are defined as polymers, the Agency has established a set of criteria
to identify categories of polymers expected to present minimal or no
risk. The definition of a polymer is given in 40 CFR 723.250(b) and the
exclusion criteria for identifying these low-risk polymers are
described in 40 CFR 723.250(d). Styrene, copolymers with acrylic acid
and/or methacrylic acid, with none and/or one or more of the following
monomers: Acrylamidopropyl methyl sulfonic acid, methallyl sulfonic
acid, 3-sulfopropyl acrylate, 3-sulfopropyl methacrylate, hydroxypropyl
methacrylate, hydroxypropyl acrylate, hydroxyethyl methacrylate, and/or
hydroxyethyl acrylate, and its sodium, potassium, ammonium,
monoethanolamine, and triethanolamine salts; (hereafter referred to as
styrene, copolymers with acrylic

acid and/or methacrylic acid) conforms to the definition of a polymer
given in 40 CFR 723.250(b) and meets the following criteria that are
used to identify low-risk polymers.
    1. The polymer is not a cationic polymer nor is it reasonably
anticipated to become a cationic polymer in a natural aquatic
environment.
    2. The polymer does contain as an integral part of its composition
the atomic elements carbon, hydrogen, and oxygen.
    3. The polymer does not contain as an integral part of its
composition, except as impurities, any element other than those listed
in 40 CFR 723.250(d)(2)(ii).
    4. The polymer is neither designed nor can it be reasonably
anticipated to substantially degrade, decompose, or depolymerize.
    5. The polymer is manufactured or imported from monomers and/or
reactants that are already included on the TSCA Chemical Substance
Inventory or manufactured under an applicable TSCA section 5 exemption.
    6. The polymer is not a water absorbing polymer with a number
average molecular weight (MW) greater than or equal to 10,000 daltons.
Additionally, the polymer also meets as required the following
exemption criteria specified in 40 CFR 723.250(e).
    7. The polymer's number average MW of 1,200 daltons is greater than
1,000 and less than 10,000 daltons. The polymer contains less than 10%
oligomeric material below MW 500 and less than 25% oligomeric material
below MW 1,000 and the polymer does not contain any reactive functional
groups. Thus, styrene, copolymers with acrylic acid and/or methacrylic
acid meets the criteria for a polymer to be considered low risk under
40 CFR 723.250. Based on its conformance to the criteria in this unit,
no mammalian toxicity is anticipated from dietary, inhalation, or
dermal exposure to styrene, copolymers with acrylic acid and/or
methacrylic acid.

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this
exemption, EPA considered that styrene, copolymers with acrylic acid
and/or methacrylic acid could be present in all raw and processed
agricultural commodities and drinking water, and that non-occupational
non-dietary exposure was possible. The number average MW of styrene,
copolymers with acrylic acid and/or methacrylic acid is 1,200 daltons.
Generally, a polymer of this size would be poorly absorbed through the
intact gastrointestinal tract or through intact human skin. Since
styrene, copolymers with acrylic acid and/or methacrylic acid conforms
to the criteria that identify a low-risk polymer, there are no concerns
for risks associated with any potential exposure scenarios that are
reasonably foreseeable. The Agency has determined that a tolerance is
not necessary to protect the public health.

V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
    EPA has not found styrene, copolymers with acrylic acid and/or
methacrylic acid to share a common mechanism of toxicity with any other
substances, and styrene, copolymers with acrylic acid and/or
methacrylic acid does not appear to produce a toxic metabolite produced
by other substances. For the purposes of this tolerance action,
therefore, EPA has assumed that styrene, copolymers with acrylic acid
and/or methacrylic acid does not have a common mechanism of toxicity
with other substances. For information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see EPA's Web site
at http://www.epa.gov/pesticides/cumulative.

VI. Additional Safety Factor for the Protection of Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base unless EPA concludes
that a different margin of safety will be safe for infants and
children. Due to the expected low toxicity of styrene, copolymers with
acrylic acid and/or methacrylic acid, EPA has not used a safety factor
analysis to assess the risk. For the same reasons the additional
tenfold safety factor is unnecessary.

VII. Determination of Safety

    Based on the conformance to the criteria used to identify a low-
risk polymer, EPA concludes that there is a reasonable certainty of no
harm to the U.S. population, including infants and children, from
aggregate exposure to residues of styrene, copolymers with acrylic acid
and/or methacrylic acid.

VIII. Other Considerations

A. Existing Exemptions From a Tolerance

    There are no existing exemptions from the requirement of a
tolerance.

B. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

C. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for styrene, copolymers with
acrylic acid and/or methacrylic acid.

 IX. Conclusion

    Accordingly, EPA finds that exempting residues of styrene,
copolymers with acrylic acid and/or methacrylic acid from the
requirement of a tolerance will be safe.

X. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these rules from review under
Executive Order 12866, entitled Regulatory Planning and Review (58 FR
51735, October 4, 1993). Because this final rule has been exempted from
review under Executive Order 12866, this final rule is not subject to
Executive Order 13211, entitled Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001) or Executive Order 13045, entitled Protection of Children
from

Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it involve any technical standards that
would require Agency consideration of voluntary consensus standards
pursuant to section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15
U.S.C. 272 note).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes, or otherwise have any unique
impacts on local governments. Thus, the Agency has determined that
Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175, entitled Consultation and Coordination
with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not
apply to this final rule. In addition, this final rule does not impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4).
    Although this action does not require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), EPA seeks to achieve
environmental justice, the fair treatment and meaningful involvement of
any group, including minority and/or low-income populations, in the
development, implementation, and enforcement of environmental laws,
regulations, and policies. As such, to the extent that information is
publicly available or was submitted in comments to EPA, the Agency
considered whether groups or segments of the population, as a result of
their location, cultural practices, or other factors, may have atypical
or disproportionately high and adverse human health impacts or
environmental effects from exposure to the pesticide discussed in this
document, compared to the general population. The Agency received one
comment from a private citizen who opposed the authorization to sell
any pesticide that leaves a residue on food. The Agency understands the
commenter's concerns and recognizes that some individuals believe that
no residue of pesticides should be allowed. The Agency has a large
database which indicates that compounds of this nature will not cause
residues which exceed the Agency's level of concern. Under the existing
legal framework provided by section 408 of the Federal Food, Drug and
Cosmetic Act (FFDCA), EPA is authorized to establish pesticide
tolerances or exemptions where persons seeking such tolerances or
exemptions have demonstrated that the pesticide meets the safety
standard imposed by the statute.

XI. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this rule in the Federal
Register. This rule is not a ``major rule'' as defined by 5 U.S.C.
804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: August 29, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.960, the table is amended by revising the entry for
``styrene, copolymers with acrylic acid and/or methacrylic acid, with
none and/or one or more of the following monomers: Acrylamidopropyl
methyl sulfonic acid, methallyl sulfonic acid, 3-sulfopropyl acrylate,
3-sulfopropyl methacrylate, hydroxypropyl methacrylate, hydroxypropyl
acrylate, hydroxyethyl methacrylate, and/or hydroxyethyl acrylate; and
its sodium, potassium, ammonium, monoethanolamine, and triethanolamine
salts; the resulting polymer having a minimum number average molecular
weight (in amu), 1,200'' to read as follows:

Sec.  180.960  Polymers; exemptions from the requirement of a
tolerance.

* * * * *

------------------------------------------------------------------------
                    Polymer                              CAS No.
------------------------------------------------------------------------

                              * * * * * * *
Styrene, copolymers with acrylic acid and/or     None.
 methacrylic acid, with none and/or one or more
 of the following monomers: Acrylamidopropyl
 methyl sulfonic acid, methallyl sulfonic acid,
 3-sulfopropyl acrylate, 3-sulfopropyl
 methacrylate, hydroxypropyl methacrylate,
 hydroxypropyl acrylate, hydroxyethyl
 methacrylate, hydroxyethyl acrylate, and/or
 lauryl methacrylate; and its sodium,
 potassium, ammonium, monoethanolamine, and
 triethanolamine salts; the resulting polymer
 having a minimum number average molecular
 weight (in amu), 1200.

                              * * * * * * *
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[FR Doc. 2013-21919 Filed 9-10-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 223 (Tuesday, November 23, 2021)]
[Notices]
[Page 66617]
[FR Doc No: 2021-25481]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2015-0062]

Florida East Coast Railway's Positive Train Control Development
Plan

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice of availability and request for comments.

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SUMMARY: This document provides the public with notice that on November
12, 2021, Florida East Coast Railway (FECR) submitted to FRA its
Positive Train Control Development Plan (PTCDP), Version 1.0, dated
November 1, 2021, and that FECR's PTCDP is available for public
comment. FECR requests that FRA approve its PTCDP, which describes the
version of Wabtec Railway Electronics' Interoperable Electronic Train
Management System (I-ETMS) that FECR intends to implement on at least
one segment of its territory.

DATES: FRA will consider comments received by December 23, 2021. FRA
may consider comments received after that date to the extent
practicable, in accordance with the applicable FRA decision deadline
under 49 CFR 236.1009(j)(2), and without delaying implementation of a
PTC system.

ADDRESSES:
    Comments: Comments may be submitted by going to https://www.regulations.gov and following the online instructions for
submitting comments.
    Instructions: All submissions must include the agency name and the
applicable docket number. The relevant PTC docket number is FRA-2015-
0062. For convenience, all active PTC dockets are hyperlinked on FRA's
website at https://railroads.dot.gov/train-control/ptc/ptc-annual-and-quarterly-reports. All comments received will be posted without change
to https://www.regulations.gov; this includes any personal information.

FOR FURTHER INFORMATION CONTACT: Gabe Neal, Staff Director, Signal,
Train Control, and Crossings Division, telephone:<PHONE_NUMBER>, email:
[email protected].

SUPPLEMENTARY INFORMATION: FECR submitted a PTCDP pursuant to Title 49
Code of Federal Regulations (CFR) 236.1009, Procedural requirements,
and 236.1013, PTC Development Plan and Notice of Product Intent content
requirements and Type Approval. FECR describes, in its PTCDP, the type
of I-ETMS it intends to implement on at least one segment of its
territory, and FECR asserts it is designed as vital overlay PTC system
as defined in 49 CFR 236.1015(e)(2). The PTCDP describes FECR's planned
I-ETMS implementation per 49 CFR 236.1013. During its review of the
PTCDP, FRA will consider whether this proposed type of I-ETMS would
satisfy the requirements for PTC systems under 49 CFR part 236, subpart
I and whether the PTCDP has made a reasonable showing that a system
built to the stated requirements would achieve the level of safety
mandated for such a system under 49 CFR 236.1015, PTC Safety Plan
content requirements and PTC System Certification. If so, in addition
to approving FECR's PTCDP, FRA, in its discretion, may issue a Type
Approval for this specific type of I-ETMS system. See 49 CFR
236.1013(b)-(d).
    FECR's PTCDP is available for review online at https://www.regulations.gov (Docket No. FRA-2015-0062). Interested parties are
invited to comment on the PTCDP by submitting written comments or data.
During FRA's review of the PTCDP, FRA will consider any comments or
data submitted within the timeline specified in this notice and to the
extent practicable. See 49 CFR 236.1009(j), 236.1011(e). Under 49 CFR
236.1013(b), FRA maintains the authority to approve, approve with
conditions, or deny railroads' PTCDPs at FRA's sole discretion.

Privacy Act Notice

    In accordance with 49 CFR 211.3, FRA solicits comments from the
public to better inform its decisions. DOT posts these comments,
without edit, including any personal information the commenter
provides, to https://www.regulations.gov, as described in the system of
records notice (DOT/ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See https://www.regulations.gov/privacy-notice for the privacy notice of regulations.gov. To facilitate
comment tracking, we encourage commenters to provide their name, or the
name of their organization; however, submission of names is completely
optional. If you wish to provide comments containing proprietary or
confidential information, please contact FRA for alternate submission
instructions.

    Issued in Washington, DC.
John Karl Alexy,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2021-25481 Filed 11-22-21; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 81, Number 49 (Monday, March 14, 2016)]
[Notices]
[Pages 13426-13429]
[FR Doc No: 2016-05586]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77316; File No. SR-MSRB-2016-03]

Self-Regulatory Organizations; Municipal Securities Rulemaking
Board; Notice of Filing and Immediate Effectiveness of a Proposed Rule
Change Consisting of an Amendment to Rule G-33, on Calculations, and an
Interpretive Notice

March 8, 2016.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'' or ``Exchange Act'') \1\ and Rule 19b-4 thereunder,\2\
notice is hereby given that on February 23, 2016, the Municipal
Securities Rulemaking Board (the ``MSRB'' or ``Board'') filed with the
Securities and Exchange Commission (the ``Commission'' or ``SEC'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the MSRB. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The MSRB filed with the Commission a proposed rule change
consisting of a proposed amendment to Rule G-33, on calculations, and a
proposed interpretive notice (the ``proposed rule change''). The MSRB
has designated the proposed rule change as ``non-controversial''
pursuant to Section 19(b)(3)(A)(iii) of the Act \3\ and Rule

19b-4(f)(6) \4\ thereunder, which renders it effective upon filing with
the Commission. A proposed rule change filed under Rule 19b-4(f)(6) \5\
normally does not become operative prior to 30 days after the date of
filing. Rule 19b-4(f)(6)(iii),\6\ however, permits the Commission to
designate a shorter time if such action is consistent with the
protection of investors and the public interest. Immediate utilization
of the amended pricing formula contained in the proposed rule change
will result in more accurate price and yield data reported to the MSRB,
which will, in turn, result in more accurate data disseminated to the
public. The MSRB requests the Commission waive the 30-day operative
delay. Such waiver would allow the MSRB to establish a compliance date
of July 18, 2016 for all dealers to conform to the amended pricing
formula, while allowing dealers the flexibility to immediately utilize
the amended pricing formula pursuant to the proposed interpretive
notice.
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    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
    \5\ Id.
    \6\ 17 CFR 240.19b-4(f)(6)(iii).
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    The text of the proposed rule change is available on the MSRB's Web
site at www.msrb.org/Rules-and-Interpretations/SEC-Filings/2016-Filings.aspx, at the MSRB's principal office, and at the Commission's
Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the MSRB included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The MSRB has prepared summaries, set forth in Sections
A, B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The proposed rule change would revise the mathematical formula in
Rule G-33(b)(i)(B)(2), which governs how brokers, dealers, and
municipal securities dealers (collectively ``dealers'') calculate the
dollar price of interest-bearing municipal securities with periodic
interest payments (e.g., daily, monthly, quarterly or annually) that
have more than six months to redemption (the ``pricing formula,'' as
amended by the proposed rule change, the ``amended pricing formula'').
The proposed rule change would also clarify that the amended pricing
formula is applicable for the calculations of municipal securities with
periodic interest payments and more than one coupon period to
redemption. The proposed rule change would similarly clarify that the
formulas in Rules G-33(b)(i)(B)(1) and G-33(b)(ii)(B)(1), which are not
being changed, are applicable for the calculations of municipal
securities with periodic interest payments and less than six months to
redemption.
    The amended pricing formula would replace a formula that was
originally designed to accommodate the technologies available at the
time of its adoption several decades ago and reflected the limited
capabilities of those technologies to efficiently conduct the more
complex and advanced calculation of the amended pricing formula.\7\
Recognizing that it resulted in only marginally less accurate price
reporting on a relatively small number of transactions, the
accommodation was made to presume that interest-bearing municipal
securities with periodic interest payments and with more than one
coupon period to redemption pay interest on a semi-annual basis. With
improved access to more technologically advanced methods of computing
dollar prices and yields, the amended pricing formula would dispense
with the six-month presumption and instead require the use of a
calculation method for yield and dollar price that is based on the
actual interest payment frequency of the security. Modernizing the
pricing formula would recognize the use of enhanced calculators by many
market participants and produce more accurate price and yield data
reported to the MSRB's Real-Time Transaction Reporting System
(``RTRS''),\8\ which the MSRB subsequently disseminates to the market
and displays on its Electronic Municipal Market Access
(``EMMA[supreg]'') system.\9\
---------------------------------------------------------------------------

    \7\ See e.g., Use of formulas: Annual interest securities, June
6, 1983. Available at http://www.msrb.org/Rules-and-Interpretations/MSRB-Rules/General/Rule-G-33.aspx?tab=2 (``1983 interpretive
letter'').
    \8\ The proposed amendments will conform the rule text regarding
the required manner of calculation by dealers to the manner in which
the MSRB currently calculates dollar price and yield for such
securities in RTRS.
    \9\ EMMA is a registered trademark of the MSRB.
---------------------------------------------------------------------------

    In addition, the MSRB is proposing an interpretive notice
(``Notice'') concerning the application of the amended pricing formula
to afford dealers the flexibility to utilize the amended pricing
formula prior to the mandatory compliance date.
Proposed Amendment to Rule G-33
    Rule G-33 prescribes standard formulas for the computation of
accrued interest, dollar price and yield, and related computations.
Specifically, Rule G-33(b)(i)(B)(2) requires that, for interest-bearing
municipal securities with periodic interest payments and more than one
coupon period to redemption, dealers compute the dollar price of such
securities using a formula that accounts for the present value of all
future coupon payments and presumes a semi-annual payment of interest
rather than the actual interest payment frequency of the security
(e.g., monthly or quarterly).\10\ By reference, Rule G-33(b)(ii)(B)(2)
requires the use of the formula in Rule G-33(b)(i)(B)(2) when
calculating the yield on such municipal securities with periodic
interest payments and more than one coupon period to redemption.
---------------------------------------------------------------------------

    \10\ The formula also accounts for the present value of the
redemption amount and the accrued interest to be paid to the seller.
Those elements of the calculation are not being changed.
---------------------------------------------------------------------------

    The proposed rule change would require, for securities subject to
Rule G-33(b)(i)(B)(2), that the dollar price for transactions effected
on the basis of yield be computed in accordance with the amended
pricing formula below:
[GRAPHIC] [TIFF OMITTED] TN14MR16.000

    The amended pricing formula modifies the pricing formula currently
prescribed by Rule G-33(b)(i)(B)(2) by eliminating the presumption in
the calculation that interest-bearing municipal securities with
periodic interest payments, and more than one coupon period to
redemption, pay interest on a semi-annual basis. Rather than calculate
for a variable of yield divided by 2 (presumed semi-annual interest
payment), the amended pricing formula requires dividing yield by ``M''
where ``M'' is the number of interest payment periods per year standard
for the security involved in the transaction.\11\
---------------------------------------------------------------------------

    \11\ All other variables remain the same and the symbols for the
formula are as defined in Rule G-33(b)(i)(B)(2).
---------------------------------------------------------------------------

    In addition, the proposed rule change would modify subparagraphs
(b)(i)(B)(2) and (b)(ii)(B)(2) to clarify the applicability of the
formula in Rule G-33(b)(i)(B)(2).\12\ Because the amended pricing
formula is adapted to future coupon payments that occur more frequently
or less frequently than semi-annually, it is more accurate to provide
that the formula is applicable for the calculations of securities with
more than one coupon period to redemption rather than ``with more than
six months to redemption.'' The proposed rule change would also make a
corresponding change to subparagraphs (b)(i)(B)(1) and (b)(ii)(B)(1).
Specifically the proposed rule change would clarify that the formulas
in Rule G-33(b)(i)(B)(1) and G-33(b)(ii)(B)(1) are applicable for
calculating dollar price and yield, respectively, on securities with
one coupon period or less to redemption rather than ``with six months
or less to redemption.''
---------------------------------------------------------------------------

    \12\ By reference, despite computing for a different end
variable, G-33(b)(ii)(B)(2) uses the pricing formula in
(b)(i)(B)(2).
---------------------------------------------------------------------------

Proposed Interpretive Notice
    With the current, wide availability of advanced calculator models,
dealers may want to utilize the more precise amended pricing formula
prior to the compliance date. The proposed interpretive notice would
provide that, prior to the compliance date for Rule G-33, as amended by
the proposed rule change, dealers would be in compliance with the
current rule if they calculate price and yield on interest-bearing
securities with periodic interest payments and more than one coupon
period to redemption factoring in the actual interest frequency in the
formula rather than assuming a semi-annual interest payment.
    The MSRB believes that allowing dealers this flexibility could
benefit transparency without creating any material discrepancies in
pricing information. Transactions in interest-bearing securities with
periodic interest payments (e.g., monthly, quarterly or annually) have
typically accounted for less than .05 percent of all transactions
reported to the MSRB annually and, as the MSRB previously recognized,
calculations for these securities that presume a semi-annual interest
payment rather than the actual interest payment frequency ``produce
slightly less accurate results.'' \13\
---------------------------------------------------------------------------

    \13\ As a result of the amended pricing formula, the MSRB will
delete the 1983 interpretive letter from its Rule Book.
---------------------------------------------------------------------------

2. Statutory Basis
    The MSRB believes that the proposed rule change is consistent with
Section 15B(b)(2)(C) of the Act, which requires, in pertinent part,
that the MSRB's rules shall be designed to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in regulating, clearing, settling, processing
information with respect to, and facilitating transactions in municipal
securities and municipal financial products, to remove impediments to
and perfect the mechanism of a free and open market in municipal
securities and municipal financial products, and, in general, to
protect investors, municipal entities, obligated persons, and the
public interest.
    The MSRB believes that the amended pricing formula will improve the
accuracy of the reporting of the dollar prices and yields on
transactions in interest-bearing municipal securities that pay interest
on a periodic basis. Additionally, the MSRB believes that the proposed
interpretive notice will afford dealers the flexibility to utilize the
more precise formula prior to the compliance date.

B. Self-Regulatory Organization's Statement on Burden on Competition

    Section 15B(b)(2)(C) \14\ of the Act requires that MSRB rules not
be designed to impose any burden on competition not necessary or
appropriate in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78o-4(b)(2)(C).
---------------------------------------------------------------------------

    In determining whether this standard has been met, the MSRB
attempted to evaluate the number of firms that may need to make changes
to comply with the proposed amendment and the likely challenges
associated with compliance. In reviewing data from 2015, the MSRB
observed that a very small percentage, approximately \1/10\ of 1
percent, of municipal securities reported to RTRS pay interest on a
periodic basis and trading in those securities accounted for less than
\1/4\ of 1 percent of customer transactions reported to the MSRB. The
MSRB believes that the impact of the proposed amendments would be very
small and would not impose any additional burdens on competition that
are not necessary or appropriate in furtherance of the purposes of the
Exchange Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received on the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Pursuant to Section 19(b)(3)(A) \15\ of the Act and Rule 19b-
4(f)(6) \16\ thereunder, the MSRB has designated the proposed rule
change as one that affects a change that does not: (i) Significantly
affect the protection of investors or the public interest; (ii) impose
any significant burden on competition; and (iii) become operative for
30 days from the date on which it was filed, or such shorter time as
the Commission may designate. A proposed rule change filed under Rule
19b-4(f)(6) normally does not become operative until 30 days after the
date of filing.\17\ However, Rule 19b-4(f)(6)(iii) permits the
Commission to designate a shorter time if consistent with the
protection of investors and the public interest.\18\
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78s(b)(3)(A).
    \16\ 17 CFR 240.19b-4(f)(6).
    \17\ Id.
    \18\ In addition, Rule 19b-4(f)(6)(iii) requires a self-
regulatory organization to give the Commission written notice of its
intent to file a proposed rule change, along with a brief
description and text of such proposed rule change, at least five
business days prior to the date of filing, or such shorter time as
designated by the Commission. The MSRB fulfilled this obligation.
---------------------------------------------------------------------------

    The MSRB has requested that the Commission waive the 30-day
operative delay specified in Rule 19b-4(f)(6)(iii).\19\ The waiver of
the 30-day operative delay will allow dealers to immediately utilize
the amended pricing formula before the July 18, 2016, compliance date.
According to the MSRB, immediate utilization of the amended pricing
formula will result in more accurate price and yield data reported to
the MSRB, which will, in turn, result in more accurate data
disseminated to the public. The Commission believes that

waiving the 30-day operative delay is consistent with the protection of
investors and the public interest as it will allow dealers to
immediately begin providing more accurate price and yield data to the
MSRB, which reflects the actual frequency of interest payments.
Accordingly, the Commission hereby waives the 30-day operative delay
specified in Rule 19b-4(f)(6)(iii) and designates the proposed rule
change to be operative upon filing.\20\
---------------------------------------------------------------------------

    \19\ See SR-MSRB-2016-03 (filed with the Commission on February
23, 2016).
    \20\ For the purpose of waiving the 30-day operative delay for
this proposal, the Commission has considered the proposed rule's
impact on efficiency, competition, and capital formation. See 15
U.S.C. 78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-MSRB-2016-03 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549.

All submissions should refer to File Number SR-MSRB-2016-03. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the MSRB. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-MSRB-2016-03 and should be
submitted on or before April 4, 2016.
---------------------------------------------------------------------------

    \21\ 17 CFR 200.30-3(a)(12).

    For the Commission, pursuant to delegated authority.\21\
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-05586 Filed 3-11-16; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 155 (Friday, August 10, 2018)]
[Notices]
[Pages 39739-39740]
[FR Doc No: 2018-17197]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER18-2159-000]

Supplemental Notice That Initial Market-Based Rate Filing
Includes Request for Blanket Section 204 Authorization; Crazy Mountain
Wind LLC

    This is a supplemental notice in the above-referenced proceeding of
Crazy Mountain Wind LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that

such application includes a request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is August 27, 2018.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the website that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
[email protected]. or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: August 6, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-17197 Filed 8-9-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 41 (Wednesday, March 2, 2011)]
[Notices]
[Page 11533]
[FR Doc No: 2011-4575]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 63954; File No. SR-ISE-2009-35]

Securities Exchange Act of 1934; In the Matter of Chicago Board
Options Exchange, Incorporated, 400 South LaSalle Street, Chicago, IL
60605; Order Setting Aside the Order by Delegated Authority Approving
SR-ISE-2009-35 and Dismissing CBOE's Petition for Review

February 24, 2011.
    On June 15, 2009, the International Securities Exchange, LLC
(``ISE'') filed a proposed rule change with the Commission seeking to
establish a Qualified Contingent Cross (``QCC'') Order. The proposed
rule change was published for comment on June 26, 2009.\1\ On August
28, 2009, the Commission approved, by authority delegated to the
Division of Trading and Markets, the proposed rule change (``Approval
Order'').\2\ On September 4, 2009, the Chicago Board Options Exchange
(``CBOE'') filed a notice of intention to file a petition for review of
the Approval Order and, on September 14, 2009, CBOE filed a petition
for review with the Commission (``Petition for Review''). Under the
Commission's Rules of Practice, the filing of CBOE's Petition for
Review automatically stayed the Approval Order.\3\ On September 11,
2009, ISE filed a motion to lift the automatic stay. On November 12,
2009, the Commission granted CBOE's Petition for Review and denied a
motion filed by ISE to lift the automatic stay.\4\
---------------------------------------------------------------------------

    \1\ See Securities Exchange Act Release No. 60147 (June 19,
2009), 74 FR 30651 (June 26, 2009).
    \2\ See Securities Exchange Act Release No. 60584 (August 28,
2009), 74 FR 45663 (September 3, 2009).
    \3\ 17 CFR Sec.  201.431(e).
    \4\ See Securities Exchange Act Release Nos. 60988 and 60989.
---------------------------------------------------------------------------

    On March 17, 2010, the Commission approved the placement in the
public file of a memorandum by its Division of Risk, Strategy, and
Financial Innovation (``RiskFin'') analyzing certain data relating to
ISE's proposed rule change (``RiskFin Memo''). At the same time that
the Commission approved placement of the RiskFin Memo in the public
file, the Commission also issued an order extending the time to file
statements in support of or in opposition to the Approval Order to give
the public an opportunity to review the data and analysis in the
RiskFin Memo.\5\
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 61722.
---------------------------------------------------------------------------

    On July 14, 2010, ISE filed a new proposed rule change to modify
the requirements for QCC Orders (file number SR-ISE-2010-73). The
Commission published for public comment the modified proposal.\6\ Also
on July 14, 2010, ISE submitted a letter requesting that the Commission
vacate the Approval Order concurrently with the approval of the new
proposed rule, SR-ISE-2010-73.\7\
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 62523 (July 16,
2010), 75 FR 43211 (July 23, 2010).
    \7\ See letter from Michael J. Simon, Secretary and General
Counsel, ISE, to Elizabeth M. Murphy, Secretary, Commission, dated
July 14, 2010.
---------------------------------------------------------------------------

    We have determined to construe ISE's request as a petition to
vacate the Approval Order pursuant to Commission Rule of Practice
431(a), which permits us to ``affirm, reverse, modify, set aside or
remand for further proceedings, in whole or in part, any action made
pursuant to'' delegated authority.\8\ We find that, in light of the
filing of ISE's modified proposal regarding the QCC Orders,\9\ it is
appropriate to grant ISE's request and set aside the Approval Order. We
also find that, given this disposition of the Approval Order, CBOE's
petition for review of that order has become moot.
---------------------------------------------------------------------------

    \8\ 17 CFR 201.431(a).
    \9\ The Commission has this day issued a separate order
approving SR-ISE-2010-73.
---------------------------------------------------------------------------

    Accordingly, it is ordered that the August 28, 2009 order approving
by delegated authority ISE's proposed rule change number SR-ISE-2009-
35, be, and it hereby is, set aside; and
    It is further ordered that the petition for review, filed by the
Chicago Board Options Exchange on September 14, 2009, of the August 28,
2009 order approving by delegated authority ISE's proposed rule change
number SR-ISE-2009-35 be, and it hereby is, dismissed.

    By the Commission.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-4575 Filed 3-1-11; 8:45 am]
BILLING CODE 8011-01-P


cost effectiveness ($/ ton), and incremental cost effectiveness ($/ ton), and/ or any other costeffectiveness measures ( such as $/ deciview);

( 5) energy impacts ( indicate any significant energy benefits or disadvantages);

( 6) non air quality environmental impacts ( includes any significant or unusual other media impacts,

e. g., water or solid waste), both positive and negative; and ( 7) modeled visibility impacts.

2. Selecting a " best" alternative 1. You have discretion to determine the order in which you should evaluate control options for BART. Whatever the order in which you choose to evaluate options, you should always ( 1) display the options evaluated; ( 2) identify the average and incremental costs of each option; ( 3) consider 104 the energy and non air quality environmental impacts of each option; ( 4) consider the remaining useful life; and ( 5)

consider the modeled visibility impacts. You should provide a justification for adopting the technology that you select as the " best" level of control, including an explanation of the CAA factors that led you to reject choose that option over other control levels.

2. In the case where you are conducting a BART determination for two regulated pollutants on the same source, if the result is two different BART technologies that do not work well together, you could then substitute a different technology or combination of technologies,

provided that they achieve at least the same emissions reductions for each pollutant.

3. In selecting a " best" alternative, should I consider the affordability of controls?

1. Even if the control technology is cost effective, there may be cases where the installation of controls would affect the viability of continued plant operations.

2. There may be unusual circumstances that justify taking into consideration the conditions of the plant and the economic effects of requiring the use of a given control technology. These effects would include effects on product prices, the market share, and profitability of the source. 105 We do not intend, for example, that the most stringent alternative must be selected, if that level would cause a plant to shut down, while a lesser degree of control would not have this effect. Where there are such unusual circumstances that are judged to have a severe affect on plant operations, you may take into consideration the conditions of the plant and the economic effects of requiring the use of a control technology. Where these effects are judged to have a severe impact on plant operations you may consider them in the selection process,

so long as you but you may wish to provide an economic analysis that demonstrates, in sufficient detail for a meaningful public review, the specific economic effects,

parameters, and reasoning. ( We recognize that this review process must preserve the confidentiality of sensitive business information). Any analysis should may also consider whether other competing plants in the same industry may also be have been required to install BART controls, if this information is available.

4. Sulfur dioxide limits for utility boilers You must require 750 MW power plants to meet specific control levels for SO2 of either 95 percent control or .15 lbs/ MMBtu, for each EGU greater than 200 MW that is currently uncontrolled, unless you determine that an 106 alternative control level is clearly justified based on a careful consideration of the statutory factors. Thus, for example, if the source convincingly demonstrates unique circumstances affecting its ability to cost effectively reduce its emissions, you should take that into account in determining whether the presumptive levels of control are appropriate for that facility. For a currently uncontrolled EGU greater than 200 MW in size, but located at a power plant smaller than 750 MW in size, such controls are generally cost effective and could be used should be carefully considered in your BART analysis determination considering the five factors specified in CAA section 169A( g)( 2). While these levels may represent current control capabilities, we expect that scrubber technology will continue to improve and control costs continue to decline. You should be sure to consider the level of control that is currently best achievable at the time that you are conducting your BART analysis.

For coal fired EGUs with existing post combustion SO2 controls achieving less than 50 percent removal efficiencies, we recommend that you evaluate constructing a new FGD system to meet the same emission limits as above ( 95 percent removal or 0.15 lb/ mmBtu), in addition to the evaluation of scrubber upgrades discussed below. For oil 107 fired units, regardless of size, you should evaluate limiting the sulfur content of the fuel oil burned to be 1 percent or less by weight.

For those BART eligible EGUs with pre existing postcombustion SO2 controls achieving removal efficiencies of at least 50 percent, your BART determination emission limit should be the result, in part, of an evaluation of consider cost effective scrubber upgrades designed to improve the system's overall SO2 removal efficiency. There are numerous scrubber enhancements available to upgrade the average removal efficiencies of all types of existing scrubber systems. We recommend that as you evaluate the definition of " upgrade," you evaluate options that not only improve the design removal efficiency of the scrubber vessel itself, but also consider upgrades that can improve the overall SO2 removal efficiency of the scrubber system. Increasing a scrubber system's reliability, and conversely decreasing its downtime, by way of optimizing operation procedures,

improving maintenance practices, adjusting scrubber chemistry, and increasing auxiliary equipment redundancy,

are all ways to improve average SO2 removal efficiencies.

We recommend that as you evaluate the performance of existing wet scrubber systems, you consider some of the following upgrades, in no particular order, as potential 108 scrubber upgrades that have been proven in the industry as cost effective means to increase overall SO2 removal of wet systems:

( a) Elimination of Bypass Reheat;

( b) Installation of Liquid Distribution Rings;

( c) Installation of Perforated Trays;

( d) Use of Organic Acid Additives;

( e) Improve or Upgrade Scrubber Auxiliary System Equipment;

( f) Redesign Spray Header or Nozzle Configuration.

We recommend that as you evaluate upgrade options for dry scrubber systems, you should consider the following cost effective upgrades, in no particular order:

( a) Use of Performance Additives;

( b) Use of more Reactive Sorbent;

( c) Increase the Pulverization Level of Sorbent;

( d) Engineering redesign of atomizer or slurry injection system.

You should evaluate scrubber upgrade options based on the 5 step BART analysis process.

5. Nitrogen oxide limits for utility boilers You should establish specific numerical limits for NOx control for each BART determination. For power plants with a generating capacity in excess of 750 MW currently using selective catalytic reduction ( SCR) or selective non catalytic reduction 109 ( SNCR) for part of the year, you should presume that use of those same controls year round is BART. For other sources currently using SCR or SNCR to reduce NOx emissions during part of the year,

you should carefully consider requiring the use of these controls year round as the additional costs of operating the equipment throughout the year would be relatively modest.

For coal fired EGUs greater than 200 MW located at greater than 750 MW power plants and operating without postcombustion controls ( i. e. SCR or SNCR), we have provided presumptive NOx limits that you should establish,

differentiated by boiler design and type of coal burned.,

unless You may determine that an alternative control level is appropriate based on a careful consideration of the statutory factors. For coal fired EGUs greater than 200 MW located at power plants 750 MW or less in size and operating without post combustion controls, you should likewise presume that these same levels are cost effective. You should require such utility boilers to meet the following NOx emission limits, unless you determine that an alternative control level is justified based on consideration of the statutory factors. The following NOx emission rates were determined based on a number of assumptions, including that the EGU boiler has enough volume to allow for installation and effective operation of 19 No Cell burners, dry turbo fired units, nor wet bottom tangential fired units burning lignite were identified as BART eligible, thus no presumptive limit was determined. Similarly, no wet bottom tangential fired units burning subbituminous were identified as BART eligible.

20 These limits reflect the design and technological assumptions discussed in the technical support document for NOx limits for these guidelines. See Technical Support Document for BART NOx Limits for Electric Generating Units and Technical Support Document for BART NOx Limits for Electric Generating Units Excel Spreadsheet, Memorandum to Docket OAR 2002 0076, April 15, 2005.

110 separated overfire air ports. For boilers where these assumptions are incorrect, these emission limits may not be cost effective.

Table 1: Presumptive NOx emission limits for BART eligible coalfired units. 19 Unit type Coal type NOx presumptive limit ( lb/ mmbtu) 20 Dry bottom wallfired Bituminous 0.39 Sub bituminous 0.23 Lignite 0.29 Tangential fired Bituminous 0.28 Sub bituminous 0.15 Lignite 0.17 Cell Burners Bituminous 0.40 Sub bituminous 0.45 Dry turbo fired Bituminous 0.32 Sub bituminous 0.23 Wet bottom tangential fired Bituminous 0.62 111 Most EGUs can meet these presumptive NOx limits through the use of current combustion control technology, i. e. the careful control of combustion air and low NOx burners. For units that cannot meet these limits using such technologies,

you should consider whether advanced combustion control technologies such as rotating opposed fire air should be used to meet these limits.

Because of the relatively high NOx emission rates of cyclone units, SCR is more cost effective than the use of current combustion control technology for these units. The use of SCRs at cyclone units burning bituminous coal,

subbituminous coal, and lignite should enable the units to cost effectively meet NOx rates of 0.10 lbs/ mmbtu. As a result, we are establishing a presumptive NOx limit of O. 10 lbs/ mmbtu based on the use of SCR for coal fired cyclone units greater than 200 MW located at 750 MW power plants.

As with the other presumptive limits established in this guideline, you may determine that an alternative level of control is appropriate based on your consideration of the relevant statutory factors. For other cyclone units, you should review the use of SCR and carefully consider whether these post combustion controls should be required as BART.

For oil fired and gas fired EGUs larger than 200MW, we believe that installation of, we recommend that you 21 See Technical Support Document for BART NOx Limits for Electric Generating Units and Technical Support Document for BART NOx Limits for Electric Generating Units Excel Spreadsheet, Memorandum to Docket OAR 2002 0076, April 15, 2005.

112 carefully consider requiring these units to install current combustion control technology to control NOx is generally highly cost effective and should be considered in your determination of BART for these sources. Many such units can make significant reductions in NOx emissions which are highly cost effective through the application of current combustion control technology. 21 V. ENFORCEABLE LIMITS/ COMPLIANCE DATE To complete the BART process, you must establish enforceable emission limits that reflect the BART requirements and require compliance within a given period of time. In particular, you must establish an enforceable emission limit for each subject emission unit at the source and for each pollutant subject to review that is emitted from the source. In addition, you must require compliance with the BART emission limitations no later than 5 years after EPA approves your regional haze SIP. If technological or economic limitations in the application of a measurement methodology to a particular emission unit would make a conventional emissions limit infeasible, you may instead prescribe a design, equipment, work practice, operation standard,

or combination of these types of standards. You should consider 113 allowing sources to " average" emissions across any set of BARTeligible emission units within a fenceline, so long as the emission reductions from each pollutant being controlled for BART would be equal to those reductions that would be obtained by simply controlling each of the BART eligible units that constitute BART eligible source.

You should ensure that any BART requirements are written in a way that clearly specifies the individual emission unit( s)

subject to BART review. Because the BART requirements themselves are " applicable" requirements of the CAA, they must be included as title V permit conditions according to the procedures established in 40 CFR part 70 or 40 CFR part 71.

Section 302( k) of the CAA requires emissions limits such as BART to be met on a continuous basis. Although this provision does not necessarily require the use of continuous emissions monitoring ( CEMs), it is important that sources employ techniques that ensure compliance on a continuous basis. Monitoring requirements generally applicable to sources, including those that are subject to BART, are governed by other regulations.

See, e. g., 40 CFR part 64 ( compliance assurance monitoring); 40 CFR 70.6( a)( 3) ( periodic monitoring); 40 CFR 70.6( c)( 1)

( sufficiency monitoring). Note also that while we do not believe that CEMs would necessarily be required for all BART sources, the vast majority of electric generating units potentially subject to 22 70 FR 9705, February 28, 2005.

114 BART already employ CEM technology for other programs, such as the acid rain program. In addition, emissions limits must be enforceable as a practical matter ( contain appropriate averaging times, compliance verification procedures and recordkeeping requirements). In light of the above, the permit must:

! be sufficient to show compliance or noncompliance ( i. e., through monitoring times of operation, fuel input, or other indices of operating conditions and practices); and ! specify a reasonable averaging time consistent with established reference methods, contain reference methods for determining compliance, and provide for adequate reporting and recordkeeping so that air quality agency personnel can determine the compliance status of the source; and ! for EGUS, specify an averaging time of a 30 day rolling average, and contain a definition of " boiler operating day" that is consistent with the definition in the proposed revisions to the NSPS for utility boilers in 40 CFR Part 60, subpart Da. 22 You should consider a boiler operating day to be any 24 hour period between 12: 00 midnight and the following midnight during which any fuel is combusted at any time at the steam 115 generating unit. This would allow 30 day rolling average emission rates to be calculated consistently across sources.


[Federal Register Volume 83, Number 233 (Tuesday, December 4, 2018)]
[Notices]
[Pages 62590-62591]
[FR Doc No: 2018-26289]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-E-4282]

Determination of Regulatory Review Period for Purposes of Patent
Extension; TRULANCE

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for TRULANCE and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
February 4, 2019. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by June 3, 2019.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 4, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 4, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

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-2017-E-4282 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; TRULANCE.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     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 Sec.
10.20 (21 CFR 10.20) and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, TRULANCE
(plecanatide) indicated in adults for treatment of chronic idiopathic
constipation. Subsequent to this approval, the USPTO received a patent
term restoration application for TRULANCE (U.S. Patent No. 7,041,786)
from Synergy Pharmaceuticals, Inc. and the USPTO requested FDA's
assistance in determining the patent's eligibility for patent term
restoration. In a letter dated September 20, 2017, FDA advised the
USPTO that this human drug product had undergone a regulatory review
period and that the approval of TRULANCE represented the first
permitted commercial marketing or use of the product. Thereafter, the
USPTO requested that FDA determine the product's regulatory review
period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
TRULANCE is 3,186 days. Of this time, 2,829 days occurred during the
testing phase of the regulatory review period, while 357 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
May 2, 2008. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was May 2, 2008.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: January
29, 2016. FDA has verified the applicant's claim that the new drug
application (NDA) for TRULANCE (NDA 208745) was initially submitted on
January 29, 2016.
    3. The date the application was approved: January 19, 2017. FDA has
verified the applicant's claim that NDA 208745 was approved on January
19, 2017.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,771 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: November 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26289 Filed 12-3-18; 8:45 am]
BILLING CODE 4164-01-P