[Federal Register Volume 82, Number 188 (Friday, September 29, 2017)]
[Notices]
[Pages 45594-45596]
[FR Doc No: 2017-20861]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-4644]

Advancement of Emerging Technology Applications for
Pharmaceutical Innovation and Modernization; Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Advancement of
Emerging Technology Applications for Pharmaceutical Innovation and
Modernization.'' This guidance finalizes the draft guidance

issued December 23, 2015, which provides recommendations to
pharmaceutical companies interested in participating in a program
involving the submission of emerging manufacturing technology. The
program is open to companies that intend to include the technology as
part of a regulatory submission including an investigational new drug
application (IND), original or supplemental new drug application (NDA),
abbreviated new drug application (ANDA) or biologic license application
(BLA), or application-associated Drug Master File (DMF) reviewed by the
Center for Drug Evaluation and Research (CDER), and where that
technology meets other criteria described in this guidance.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-D-4644 for ``Advancement of Emerging Technology Applications
for Pharmaceutical Innovation and Modernization.'' 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.
     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.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.
    Submit written requests for single copies of this 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Sau L. Lee, Center for Drug Evaluation
and Research, Food and Drug Administration, Bldg. 22, Rm. 2128, 10903
New Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or for
further information or to submit requests to participate in the
program, please use<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Advancement of Emerging Technology Applications for
Pharmaceutical Innovation and Modernization.'' FDA is committed to
supporting and enabling pharmaceutical innovation and modernization as
part of the Agency's mission to protect and promote the public health.
While the implementation of emerging technology is critical to
advancing product design, modernizing pharmaceutical manufacturing, and
improving quality, FDA also recognizes that the adoption of innovative
approaches may represent challenges to industry and the Agency.
    Issues in pharmaceutical manufacturing have the potential to
significantly impact patient care as failures in quality may result in
product recalls and harm to patients. Additionally, product failures or
facility, equipment, or manufacturing problems are a major factor
leading to disruptions in drug supply. Modernizing manufacturing
technology may lead to a more robust manufacturing process with fewer
interruptions in production, fewer product failures (before or after
distribution), and greater assurance that the drug products
manufactured in any given period of time will provide the expected
clinical performance. Encouraging development of emerging technology
may lead to pharmaceutical innovation and modernization, such as a more
robust drug product design and improved manufacturing with better
process control, thereby leading to improved product quality and
availability throughout a product's lifecycle.
    In this program, pharmaceutical companies can, prior to the
regulatory submission, submit questions and proposals about the use of
specific emerging technology to a group within

the FDA Emerging Technology Team (ETT), which includes relevant
representation from all FDA pharmaceutical quality functions. The ETT
works in partnership with relevant pharmaceutical quality offices and
assumes a leadership or co-leadership role for the cross-functional
quality assessment team (including review and on-site facility
evaluation or inspection) for submissions involving emerging
technology.
    This guidance finalizes the draft guidance issued December 23, 2015
(80 FR 79907). It provides further clarification on the criteria that
the proposed technology needs to meet for its acceptance into the
Emerging Technology Program. It also clarifies types of novel
technology (e.g., product technology, manufacturing process, and
control strategy) that can be covered by the program.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on advancement of emerging technology
applications for pharmaceutical innovation and modernization. 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. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
information to be included in a meeting request for a product submitted
in an IND, BLA, or NDA is approved by OMB control number 0910-0429
(``Guidance for Industry on Formal Meetings Between the FDA and
Sponsors or Applicants''). Information to be included in a meeting
request for a product submitted in an ANDA is approved by OMB control
number 0910-0797 (``Guidance on Controlled Correspondence Related to
Generic Drug Development''). The submission of INDs under 21 CFR 312.23
is approved by OMB control number 0910-0014; the submission of BLAs
under 21 CFR 601.2 and 601.12 is approved by OMB control number 0910-
0338; and the submission of NDAs and ANDAs under 21 CFR 314.50, 314.70,
314.71, 314.94, and 314.97 is approved by OMB control number 0910-0001.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: September 22, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20861 Filed 9-28-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 70 (Thursday, April 11, 2019)]
[Notices]
[Pages 14714-14715]
[FR Doc No: 2019-07137]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2019-0011]

Petition for Waiver of Compliance

    Under part 211 of Title 49 Code of Federal Regulations (CFR), this
document provides the public notice that on December 19, 2018, the
Union Pacific Railroad (UPRR) petitioned the Federal Railroad
Administration (FRA) for a waiver of compliance from certain provisions
of the Federal railroad safety regulations contained at 49 CFR 229.21,
Daily inspection, which requires that each locomotive in use be
inspected

once each calendar day. FRA assigned the petition Docket Number FRA-
2019-0011.
    Specifically, UPRR seeks the ability to forgo daily inspections on
Distributed Power (DPU) locomotives that are en route. Daily
inspections on DPU locomotives would still be performed before
departing the originating terminal and before the locomotive's next
usage after arrival at the train destination. UPRR states that many
trains operating along the UPRR network typically arrive at their
destination within 48 to 72 hours; with the longest routes operating in
an 84- to 96-hour time range. Daily inspections of DPU locomotives
performed en route often take place on the main line and in close
proximity to other main line live tracks. Train delay created by
conducting these inspections can at times result in blocked crossings.
These situations can pose an unnecessary safety risk to both the
general public and crew members as well.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue SE, W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested parties
desire an opportunity for oral comment and a public hearing, they
should notify FRA, in writing, before the end of the comment period and
specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Website: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE, Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by May 28, 2019 will be considered by FRA
before final action is taken. Comments received after that date will be
considered if practicable.
    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
Under 5 U.S.C. 553(c), DOT solicits comments from the public to better
inform its processes. DOT posts these comments, without edit, including
any personal information the commenter provides, to
www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacyNotice for the
privacy notice of regulations.gov.

    Issued in Washington, DC.
John Karl Alexy,
Deputy Associate Administrator Office of Railroad Safety.
[FR Doc. 2019-07137 Filed 4-10-19; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 88, Number 90 (Wednesday, May 10, 2023)]
[Notices]
[Pages 30185-30187]
[FR Doc No: 2023-09905]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-97432; File No. SR-CboeEDGA-2023-007]

Self-Regulatory Organizations; Cboe EDGA Exchange, Inc.; Notice
of Filing and Immediate Effectiveness of a Proposed Rule Change To
Amend Its Fee Schedule

May 4, 2023.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on May 1, 2023, Cboe EDGA Exchange, Inc. (the ``Exchange'' or
``EDGA'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. 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

    Cboe EDGA Exchange, Inc. (the ``Exchange'' or ``EDGA'') proposes to
amend its Fee Schedule. The text of the proposed rule change is
provided in Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/equities/regulation/rule_filings/edga/), at the Exchange's Office of the Secretary, 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 Exchange 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 Exchange 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 Exchange proposes to amend its Fee Schedule applicable to its
equities trading platform (``EDGA Equities'') by introducing new fee
code DX and modifying the description of existing fee code DQ. The
Exchange proposes to implement these changes effective May 1, 2023.
    The Exchange first notes that it operates in a highly competitive
market in which market participants can readily direct order flow to
competing venues if they deem fee levels at a particular venue to be
excessive or incentives to be insufficient. More specifically, the
Exchange is only one of 16 registered equities exchanges, as well as a
number of alternative trading systems and other off-exchange venues
that do not have similar self-regulatory responsibilities under the
Securities Exchange Act of 1934 (the ``Act''), to which market
participants may direct their order flow. Based on publicly available
information,\3\ no single registered equities exchange has more than
16% of the market share. Thus, in such a low-concentrated and highly
competitive market, no single equities exchange possesses significant
pricing power in the execution of order flow. The Exchange in
particular operates a ``Taker-Maker'' model whereby it pays credits to
members that remove liquidity and assesses fees to those that add
liquidity. The Exchange's Fee Schedule sets forth the standard rebates
and rates applied per share for orders that remove and provide
liquidity, respectively. Currently, for orders in securities priced at
or above $1.00, the Exchange provides a standard rebate of $0.00180
[sic] per share for orders that remove liquidity and assesses a fee of
$0.0030 per share for orders that add liquidity.\4\ For orders in
securities priced below $1.00, the Exchange does not assess any fees or
provide any rebates for orders that add or remove liquidity.\5\
Additionally, in response to the competitive environment, the Exchange
also offers tiered pricing which provides Members opportunities to
qualify for higher rebates or reduced fees where certain volume
criteria and thresholds are met. Tiered pricing provides an incremental
incentive for Members to strive for higher tier levels, which provides
increasingly higher benefits or discounts for satisfying increasingly
more stringent criteria.
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    \3\ See Cboe Global Markets, U.S. Equities Market Volume
Summary, Month-to-Date (April 21, 2023), available at https://www.cboe.com/us/equities/market_statistics/.
    \4\ See EDGA Equities Fee Schedule, Standard Rates.
    \5\ Id.
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Fee Codes DQ and DX
    The Exchange currently offers fee code DQ, which is appended to
Midpoint Discretionary Orders (``MDOs'') \6\ using the Quote Depletion
Protection (``QDP'') \7\ order instruction. QDP is designed to provide
enhanced protections to MDOs by tracking significant executions that
constitute the best bid or offer on the EDGA Book \8\ and enabling
Users to avoid potentially unfavorable executions by preventing MDOs
entered with the optional QDP instruction from exercising discretion to
trade at more aggressive prices when

QDP has been triggered.\9\ Currently, MDOs entered with the QDP
instruction are appended fee code DQ and assessed a flat fee of
$0.00040 per share in securities at or above $1.00 and 0.30% of dollar
value for securities priced below $1.00. The Exchange now proposes to
amend fee code DQ to be appended to MDOs entered with a QDP instruction
that add liquidity to the Exchange. The Exchange also proposes to amend
the fee associated with fee code DQ from $0.00040 per share in
securities at or above to $1.00 to $0.0010 per share. The Exchange also
proposes to introduce fee code DX, which would be appended to MDOs with
a QDP instruction that remove liquidity from the Exchange. Orders
appended with fee code DX would be assessed a fee of $0.00040 per share
in securities at or above $1.00 and 0.30% of dollar value for
securities priced below $1.00.
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    \6\ See Exchange Rule 11.8(e).
    \7\ See Exchange Rule 11.8(e)(10).
    \8\ See Exchange Rule 1.5(d).
    \9\ See Securities Exchange Act Release No. 89016 (June 4,
2020), 85 FR 35488 (June 10, 2020) (SR-CboeEDGA-2020-005) (``Notice
of Filing of Amendment No. 1 and Order Granting Accelerated Approval
of a Proposed Rule Change, as Modified by Amendment No. 1, to Amend
the Rule Relating to MidPoint Discretionary Orders to Allow Optional
Offset or Quote Depletion Protection Instructions'').
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2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act and the rules and regulations thereunder applicable to the
Exchange and, in particular, the requirements of Section 6(b) of the
Act.\10\ Specifically, the Exchange believes the proposed rule change
is consistent with the Section 6(b)(5) \11\ requirements that the rules
of an exchange be designed to prevent fraudulent and manipulative acts
and practices, 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 securities, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general, to protect investors and the public interest.
Additionally, the Exchange believes the proposed rule change is
consistent with the Section 6(b)(5) \12\ requirement that the rules of
an exchange not be designed to permit unfair discrimination between
customers, issuers, brokers, or dealers as well as Section 6(b)(4) \13\
as it is designed to provide for the equitable allocation of reasonable
dues, fees and other charges among its Members and other persons using
its facilities.
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    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(5).
    \12\ Id.
    \13\ 15 U.S.C. 78f(b)(4).
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    As described above, the Exchange operates in a highly competitive
market in which market participants can readily direct order flow to
competing venues if they deem fee levels at a particular venue to be
excessive or incentives to be insufficient. The Exchange believes the
proposed addition of fee code DX and the revised applicability of fee
code DQ are reasonable as the Exchange offers many other fee codes that
are specifically designed for orders that add liquidity to the Exchange
or remove liquidity from the Exchange.\14\ In addition, the Exchange
notes that its affiliate exchanges have adopted a similar pricing
structure for MDOs containing a QDP instruction.\15\ While the fee
assessed for orders appended with fee code DQ will be slightly higher
than the fee assessed for orders appended with fee code DX, the
Exchange believes that promoting liquidity-removing MDOs containing a
QDP instruction represents an equitable allocation of fees and rebates
and is not unfairly discriminatory because the fees will apply to all
Members who add or remove liquidity utilizing an MDO with a QDP
instruction, equally. Furthermore, the Exchange believes that assessing
a lower fee under fee code DX will promote a reasonable means to
encourage liquidity removing volume to the Exchange for MDOs utilizing
a QDP instruction. While Members are assessed a small fee to utilize
MDOs with a QDP instruction, the Exchange believes that promoting
liquidity removing activity would help deepen the Exchange's liquidity
pool, support the quality of price discovery, and improve market
quality, for all investors.
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    \14\ See e.g., EDGA Equities Fee Schedule, Fee Codes 3 and 6.
    \15\ See e.g., EDGX Equities Fee Schedule, Fee Codes DQ and DX.
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. Rather, as discussed above,
the Exchange believes that the proposed changes would encourage the
submission of additional order flow to a public exchange, thereby
promoting market depth, execution incentives and enhanced execution
opportunities, as well as price discovery and transparency for all
Members. As a result, the Exchange believes that the proposed changes
further the Commission's goal in adopting Regulation NMS of fostering
competition among orders, which promotes ``more efficient pricing of
individual stocks for all types of orders, large and small.''
    The Exchange believes the proposed rule changes do not impose any
burden on intramarket competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed fees associated
with fee code DX would apply to all Members equally in that all Members
would be subject to the same flat fee for the execution of an MDO with
a QDP instruction that removes liquidity from the Exchange. Although
MDOs entered with the QDP instruction would be subject to the pricing
described in this proposed rule change, the Exchange does not believe
that pricing would impose any significant burden on intramarket
competition as this fee would be applied in the same manner to the
execution of any MDO entered with a QDP instruction that removes
liquidity from the Exchange. Both MDO and the associated QDP
instruction are available to all Members on an equal and non-
discriminatory basis. As a result, any Member can decide to use (or not
use) the QDP instruction based on the benefits provided by that
instruction in potentially avoiding unfavorable executions, and the
associated charge that the Exchange proposes to introduce. As
discussed, any firm that chooses to use the QDP instruction with an MDO
that removes liquidity would be charged the same flat fee for the
execution of orders that are entered with this instruction. The
proposal to modify fee code DQ to apply only to MDO orders using the
QDP instruction that add liquidity to the Exchange similarly does not
impose a burden on intramarket competition in that the applicability of
the fee code will apply equally to all Members in that all Members
would be subject to the same, revised flat fee for the execution of an
MDO with a QDP instruction that adds liquidity to the Exchange.
    Next, the Exchange believes the proposed rule changes does not
impose any burden on intermarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act. As previously
discussed, the Exchange operates in a highly competitive market.
Members have numerous alternative venues that they may participate on
and direct their order flow, including other equities exchanges, off-
exchange venues, and alternative trading systems. Additionally, the
Exchange represents a small percentage of the overall market.

Based on publicly available information, no single equities exchange
has more than 16% of the market share.\16\ Therefore, no exchange
possesses significant pricing power in the execution of order flow.
Indeed, participants can readily choose to send their orders to other
exchange and off-exchange venues if they deem fee levels at those other
venues to be more favorable. Moreover, the Commission has repeatedly
expressed its preference for competition over regulatory intervention
in determining prices, products, and services in the securities
markets. Specifically, in Regulation NMS, the Commission highlighted
the importance of market forces in determining prices and SRO revenues
and, also, recognized that current regulation of the market system
``has been remarkably successful in promoting market competition in its
broader forms that are most important to investors and listed
companies.'' \17\ The fact that this market is competitive has also
long been recognized by the courts. In NetCoalition v. Securities and
Exchange Commission, the D.C. Circuit stated as follows: ``[n]o one
disputes that competition for order flow is `fierce.' . . . As the SEC
explained, `[i]n the U.S. national market system, buyers and sellers of
securities, and the broker-dealers that act as their order-routing
agents, have a wide range of choices of where to route orders for
execution'; [and] `no exchange can afford to take its market share
percentages for granted' because `no exchange possesses a monopoly,
regulatory or otherwise, in the execution of order flow from broker
dealers'. . . .''.\18\ Accordingly, the Exchange does not believe its
proposed fee change imposes any burden on competition that is not
necessary or appropriate in furtherance of the purposes of the Act.
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    \16\ Supra note 3.
    \17\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496, 37499 (June 29, 2005).
    \18\ NetCoalition v. SEC, 615 F.3d 525, 539 (D.C. Cir. 2010)
(quoting Securities Exchange Act Release No. 59039 (December 2,
2008), 73 FR 74770, 74782-83 (December 9, 2008) (SR-NYSEArca-2006-
21)).
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange neither solicited nor received comments on the
proposed rule change.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \19\ and paragraph (f) of Rule 19b-4 \20\
thereunder. 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. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
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    \19\ 15 U.S.C. 78s(b)(3)(A).
    \20\ 17 CFR 240.19b-4(f).
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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 protected]. Please include
File Number SR-CboeEDGA-2023-007 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-CboeEDGA-2023-007. 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 website (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 website 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 Exchange. Do not include
personal identifiable information in submissions; you should submit
only information that you wish to make available publicly. We may
redact in part or withhold entirely from publication submitted material
that is obscene or subject to copyright protection. All submissions
should refer to File Number SR-CboeEDGA-2023-007, and should be
submitted on or before May 31, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\21\
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    \21\ 17 CFR 200.30-3(a)(12).
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Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-09905 Filed 5-9-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 78 (Wednesday, April 23, 2014)]
[Notices]
[Pages 22671-22672]
[FR Doc No: 2014-09256]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9909-90-Region-5]

Public Water System Supervision Program Approval for the State of
Ohio

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of tentative approval.

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SUMMARY: Notice is hereby given that the Environmental Protection
Agency (EPA) has tentatively approved revisions to the State of Ohio's
public water system supervision program. Ohio EPA has revised two of
its rules to comply with the National Primary Drinking Water
Regulations, including the Long-Term 1 Enhanced Surface Water Treatment
Rule (LT1ESWTR) and the Lead and Copper Rule Short-Term Revisions and
Clarifications. EPA has determined that these revisions are consistent
with and no less stringent than the corresponding federal regulations.
Therefore, EPA intends to approve these revisions to the State of
Ohio's public water system supervision program, thereby giving Ohio EPA
primary enforcement responsibility for these regulations. Ohio EPA has
been implementing the LT1ESWTR since August 3, 2004, and Ohio EPA has
been administering the revised lead and copper requirements since July
24, 2009.
    Any interested party may request a public hearing. A request for a
public hearing must be submitted by May 23, 2014 to the Regional
Administrator at the EPA Region 5 address shown below. The Regional
Administrator may deny frivolous or insubstantial requests for a
hearing. However, if a substantial request for a public hearing is made
by May 23, 2014 EPA Region 5 will hold a public hearing, and a notice
of such hearing will be given in the Federal Register and a newspaper
of general circulation. If EPA Region 5 does not receive a timely and
appropriate request for a hearing and the Regional Administrator does
not elect to hold a hearing on her own motion, this determination shall
become final and effective on May 23, 2014. Any request for a public
hearing shall include the following information: The name, address, and
telephone number of the individual, organization, or other entity
requesting a hearing; a brief statement of the requesting person's
interest in the Regional Administrator's determination and a brief
statement of the information that the requesting person intends to
submit at such hearing; and the signature of the individual making the
request, or, if the request is made on

behalf of an organization or other entity, the signature of a
responsible official of the organization or other entity.

ADDRESSES: All documents relating to this determination are available
for inspection at the following offices: Ohio Environmental Protection
Agency, Division of Drinking and Ground Waters, 50 West Town Street,
Suite 700, Columbus, Ohio 43215, between the hours of 8:00 a.m. and
5:00 p.m., Monday through Friday, and the United States Environmental
Protection Agency, Region 5, Ground Water and Drinking Water Branch
(WG-15J), 77 West Jackson Boulevard, Chicago, Illinois 60604, between
the hours of 9:00 a.m. and 4:30 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Wendy Drake, EPA Region 5, Ground
Water and Drinking Water Branch, at the address given above, by
telephone at<PHONE_NUMBER>, or at<EMAIL_ADDRESS>
    Authority: Section 1413 of the Safe Drinking Water Act, 42
U.S.C. 300g-2, and the federal regulations implementing Section 1413
of the Act set forth at 40 CFR part 142.

    Dated: April 3, 2014.
Susan Hedman,
Regional Administrator, Region 5.
[FR Doc. 2014-09256 Filed 4-22-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)]
[Notices]
[Page 46533]
[FR Doc No: 2018-19918]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2008-0070]

Petition for Waiver of Compliance

    In accordance with part 211 of Title 49 of the Code of Federal
Regulations (CFR), this provides the public notice that by letter dated
September 7, 2018, Harsco Track Technologies (HTT) petitioned the
Federal Railroad Administration (FRA) for an extension of a waiver of
compliance from certain provisions of the Federal railroad safety
regulations contained at 49 CFR part 214, subpart D. FRA assigned the
petition Docket Number FRA-2008-0070.
    HTT seeks an extension of the existing relief from 49 CFR 214.505,
Required environmental control and protection systems for new on-track
roadway maintenance machine with enclosed cabs, to permit continued use
of a remote controlled on-track roadway maintenance machine without the
requirement of an enclosed cab, operable heating and air conditioning
system, and positive pressurized ventilation system. In support of its
petition, HTT states the drone track tamper has been in operation since
2008 and no injuries or safety issues have been reported to HTT.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's Docket Operations Facility, 1200 New Jersey Ave. SE,
W12-140, Washington, DC 20590. The Docket Operations Facility is open
from 9 a.m. to 5 p.m., Monday through Friday, except Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Website: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE, Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by October 15, 2018 will be considered by
FRA before final action is taken. Comments received after that date
will be considered as far as practicable.
    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.). In
accordance with 5 U.S.C. 553(c), DOT solicits comments from the public
to better inform its processes. DOT posts these comments, without edit,
including any personal information the commenter provides, to
www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at www.dotransportation.gov/privacy. See also http://www.regulations.gov/#!privacyNotice for the
privacy notice of regulations.gov.

    Issued in Washington, DC.
Robert C. Lauby,
Associate Administrator for Safety, Chief Safety Officer.
[FR Doc. 2018-19918 Filed 9-12-18; 8:45 am]
 BILLING CODE 4910-06-P


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: [Jennifer Gaines --<PHONE_NUMBER>]

INSTRUCTIONS:  Please utilize this outline in preparing the pesticide petition.  In cases where the outline element does not apply, please insert "NA-Remove" and maintain the outline. Please do not change the margins, font, or format in your pesticide petition. Simply replace the instructions that appear in green, i.e., "[insert company name]," with the information specific to your action.

TEMPLATE:

Makhteshim Agan of North America, Inc.

[Insert petition number]

	EPA has received a pesticide petition ([insert petition number]) from Makhteshim Agan of North America, Inc, 3120 Highwoods Blvd, Suite 100, Raleigh, NC 27604 requesting, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180

   	By establishing a tolerance for residues of

	Fluensulfone equivalents (i.e., the sum of thiazole sulfonic acid (TSA) and butene sulfonic acid (BSA) expressed as total fluensulfone equivalents) in or on the raw agricultural commodity fruiting vegetables at 0.6 parts per million (ppm) and cucurbits at 1.0 parts per million (ppm).  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

      1. Plant metabolism.  Fluensulfone is supported by a complete plant metabolism data package based on the proposed uses on fruiting vegetables (crop group 8) and cucurbit vegetables (crop group 9).  In all plant matrices, whether from a primary or rotational crop, a clear pattern was observed with TSA (M-3625) and BSA (M-3627) forming the majority of the residues following the cleavage of fluensulfone.  Neither compound has acute oral toxicity greater than parent fluensulfone or shows any genotoxic potential in a range of mutagenicity studies.  The residues definition for both monitoring and risk assessment should therefore be the sum of TSA and BSA, expressed as fluensulfone equivalents.

	2. Analytical method. Adequate analytical methods for determining fluensulfone in/on appropriate raw agricultural commodities and processed commodities have been developed and validated, including LC-MS/MS methods for use on tomato, pepper, melon, and cucumber.  The analytical procedures have been successfully validated in terms of specificity, linearity, precision, accuracy and LOQ.

      The MRM study demonstrates that the FDA multiresidue methods (MRMs) are not suitable for detection and enforcement of fluensulfone residues as sulfonic acid metabolites in non-fatty matrices.

	3. Magnitude of residues. Fluensulfone is proposed for use on field grown cucurbits and fruiting vegetables. To support these uses an extensive residues package has been generated at field trial sites in the USA and Canada in 2009-2010.  Fluensulfone, M-3625 (TSA) and M-3627(BSA) were sought in all samples.  No residues of fluensulfone were detected in any samples. The LOQ for fluensulfone and the metabolites was 0.01 mg/kg.

Adequate data are available to propose tolerances (MRLs) and there is no unacceptable risk to consumers from the consumption of crops treated with formulations containing fluensulfone.

B. Toxicological Profile

      1. Acute toxicity.  The acute oral LD50 is 671 mg/kg bw in rats.  The acute dermal LD50 of fluensulfone is >2000 mg/kg bw.  The acute inhalation LD50 in rats is >5.1 mg/L.  Fluensulfone displayed no eye irritation in rabbits.  Fluensulfone is not irritating to the skin and is a skin sensitizer.

      2. Genotoxicty. A complete data package of in vitro and in vivo mutagenicity studies is available for fluensulfone.  A full summary of the genotoxicity database is provided in the OECD Dossier.  On the basis of the robust in vitro and in vivo mutagenicity data, it is concluded that fluensulfone does not possess any genotoxic potential.

      3. Reproductive and developmental toxicity. The reproductive toxicity of fluensulfone was evaluated in a 2-generation reproduction study in rats. Developmental toxicity was assessed in rats and rabbits.

      Reproductive toxicity.  A 2-generation reproduction study in rats was conducted at dose levels of 0, 30, 250 and 1800 ppm (2.0, 16.2, and 122.0 mg/kg/day in males and 2.8, 23.0 and 169.1 mg/kg/day in females).  Treatment with fluensulfone up to and including 1800 ppm, the highest tested dose level, showed no effects on reproductive function, including gonadal function, mating behavior, fertility, viability of offspring, breeding, conception, gestation and parturition.

      Parental systemic toxicity was evident however, with effects on body weight development throughout the study observed at 1800 ppm (the LOAEL); hence the NOAEL was set at 250 ppm (equivalent to approximately 16.2 mg/kg/day in males and 23.0 mg/kg /day in females). A NOAEL for general toxicity in F1 and F2 pups was established at 250 ppm, based on reduced pup weight noted at 1800 ppm.

      Developmental toxicity.  Fluensulfone was not teratogenic or fetotoxic either in rats or rabbits.

      A pre-natal developmental study in rats included dose groups of 0, 7.7, 48.6, and 292.0 mg/kg/day.  Maternal toxicity, manifested as decreased body weight gain and food consumption in rats, resulted in a lower body weight of female pups; the maternal and developmental NOAEL was set at 48.6 mg/kg/day.

      A pre-natal developmental study in rabbits included dose groups of 0, 2.5, 10 and 40 mg/kg/day.  Similarly, as with the study in rats, treatment of rabbits at 40 mg/kg/day resulted in slight maternal toxicity consisting of reduction in food consumption at the onset of the treatment and between days 18 and 24, and reduced mean body weight gain at the beginning of the treatment only. As the lower fetal weights recorded at this dose level were within the range of the historical control data, the NOAEL for maternal and developmental toxicity was considered to be 40 mg/kg/day, the highest dose tested.

      4. Subchronic toxicity. Repeated dose, oral (dietary) toxicity studies with fluensulfone are available for rats, mice and dogs.  The studies conducted include 28-day and 90-day studies in the rat, mouse, and dog.  In addition, a 1-year oral toxicity study in dogs and a 28-day dermal toxicity study in rats were performed.

The rat 28-day study was conducted at dose levels of 0, 125, 500, and 2000 ppm (0, 10.4, 42.5, and 152 mg/kg/day in males and 0, 12.2, 37.2, and 165.9 mg/kg/day in females).  The NOAEL was 125 ppm (10.4 and 12.2 mg/kg day in males and females respectively), based on results at the LOAEL of functional effects in the liver and kidney effects, which were considered adverse as a precaution but likely of no toxicological relevance.

The mouse 28-day study was conducted at dose levels of 0, 100, 500, and 2000 ppm (0, 30.33, 101.31, and 374.5 mg/kg/day in males and 0, 41.32, 155.12, and 353.0 mg/kg/day in females).  The NOAEL was 100 ppm (30.33 and 41.32 mg/kg/day in males and females respectively), based on results at the LOAEL of decreased food consumption and liver toxicity (increased relative weight, histopathological findings).

The dog 28-day study was conducted at dose levels of 0, 50, 200, and 900 ppm (1.9, 7.3, and 30.9 mg/kg/day in males and 2.0, 7.9, and 29.7 mg/kg/day in females).  The NOAEL was 200 ppm (7.3 and 7.9 mg/kg/day in males and females respectively), based on results at the LOAEL of slight changes in food consumption, body weight and organ weight (liver and thyroid) and on hepatic tissue enzyme activities.

The rat subchronic 90-day study was conducted at dose levels of 0, 60, 120, 500 and 2000 ppm (4.31, 8.26, 34.86, and 139.01 mg/kg/day in males and 4.85, 11.68, 53.10 and 148.73 mg/kg/day in females).  The NOAEL was 120 ppm (8.3 and 11.7 mg/kg/day in males and females respectively), based on results at the LOAEL of decreased body weight/body weight gain in males, increased water consumption in males and increased triglycerides in females.

The mouse subchronic 90-day study was conducted at dose levels of 0, 60, 300, and 1500 ppm (11.06, 50.85, and 228.53 mg/kg/day in males and 18.33, 68.47 and 252.49 mg/kg/day in females).  The NOAEL was 60 ppm (11.06 and 18.33 mg/kg/day in males and females, respectively), based on results at the LOAEL of decreased food consumption in females and marginal effects in liver and hematological findings in males.

The dog subchronic 90-day study was conducted at dose levels of 0, 5, 50, and 500 ppm (0.2, 1.6 and 17.1 mg/kg/day in males and 0.2, 1.8 and 18.0 mg/kg/day in females).  The NOAEL was 500 ppm (17.1 and 18.0 mg/kg/day in males and females, respectively), based on only slight and reversible liver effects at the top dose tested.

The rat 28-day dermal study was conducted at dose levels of 0, 80, 400, and 2000 mg/kg/day in males and females.  Only a minimal increase in the incidence of acanthosis/hyperkeratosis was observed at the limit dose of 2000 mg/kg/day.  However, because of the moderate degree recorded in comparison to the vehicle control, the finding was considered adaptive and likely to be reversible after cessation of treatment and on this basis not adverse. The NOAEL was 2000 mg/kg/day, the highest dose tested, based on no systemic or adverse dermal effects at the highest dose level tested.

In all species the liver appears to be the main target organ, although often the observed effects were limited to adaptive changes (e.g. hepatocyte hypertrophy concomitant to increased weight, induction of mainly phase II activities). Investigations on liver enzyme activities in all species revealed that fluensulfone administration does not result in significant induction of (activating) phase I cytochrome P450 subfamilies, but that the (conjugating) phase II enzymes were induced. Frank hepatotoxicity was observed only at very high doses, and only in mice.

The NOAEL for oral subchronic toxicity is 8.3 mg/kg bw/day based on decreased body weights in males (and supported by increased triglycerides in females at the same dietary dose) in the 90 day rat study. The NOAEL for dermal subchronic toxicity is 2000 mg/kg bw/day, based on absence of adverse effects at the highest test dose in the rat 28-day dermal toxicity study.

      5. Chronic toxicity. The long-term toxicity and carcinogenicity potential of fluensulfone was evaluated in dogs (one year study), rats (combined study for chronic toxicity and carcinogenicity), and mice (carcinogenicity).

In a 1-year oral toxicity study in dogs, fluensulfone was administered in the diet at 0, 5, 50 100 and 500 ppm (0.1, 1.5, 3.1, and 19 mg/kg/day in males and 0.1, 1.5, 3.3, and 16.2 mg/kg/day in females) to purebred Beagle dogs for a period of 52 weeks with selected animals retained for an 8-week recovery period.  The NOAEL was considered to be 100 ppm (3.1 mg/kg bw/day in males and 3.3 mg/kg bw/day in females), based on decreased body weight and body weight gains, decreased hemoglobin, MCH, MCHC and increased kidney weights at 500 ppm (16.0 and 16.2 mg/kg/day in males and females respectively) in the diet.
A combined chronic dietary toxicity and carcinogenicity study in rats was conducted with 0, 30, 200, and 1200 ppm dose groups (1.6, 11 and 66.3 mg/kg/day after 52 weeks and 1.4, 9.6 and 57.7 mg/kg/day after 104 weeks in males; 1.9, 13.1 and 75.2 mg/kg/day after 52 weeks and 1.7, 11.6 and 69.3 mg/kg/day after 104 weeks in females). Fluensulfone showed no carcinogenic potential in this study, and the NOAEL for lifespan treatment (2-years) was set at 30 ppm (1.4 mg/kg/day in males and 1.7 mg/kg/day in females) on the basis of chronic interstitial inflammation in the lungs of females, decreased body weight and body weight gain in males, and decreased hemoglobin concentration and hemoglobin concentration distribution width in females receiving 200 ppm.

A 78-week dietary carcinogenicity study in mice was conducted with 0, 30, 200, and 1200 ppm dose groups (4.2, 27.6 and 152.3 mg/kg/day in males and 6.4, 39.0, and 188.4 in females).  The overall NOEL in mice following lifespan treatment was set at 30 ppm (4.2 and 6.4 mg/kg/day in males and females, respectively). In mice, treatment with fluensulfone for 78 weeks resulted in an increased incidence of alveolar/bronchiolar adenomas in females receiving 200 and 1200 ppm. Mechanistic studies were carried out to determine the relevance for humans of this finding. Tumors were found to be a species-specific effect in mice due to activation of fluensulfone by mouse lung Clara cells, leading to local cytotoxicity, cell proliferation and finally formation of benign tumors.  Rats have lower metabolic activity in the lungs compared to mice (below the threshold needed to cause lung tumors upon lifetime exposure) and activity in humans is orders of magnitude lower than rats.  Fluensulfone was found to be extensively metabolized by mouse lung microsomes, whereas no metabolic activity was seen in human lung microsomes.    In accordance with the International Programme on Chemical Safety (IPCS) mode of action and human relevance framework, it is concluded that fluensulfone leads to species-specific tumors via a non-genotoxic threshold mode of action in the mouse lung, and that these tumors are not relevant to human hazard or risk.

The NOAEL for lifespan treatment was set at 1.4 mg/kg/day on the basis of decreased body weight and body weight gain in males (supported by chronic interstitial inflammation in the lungs and decreased hemoglobin concentration and hemoglobin concentration distribution width in females).

      6. Neurotoxicity. Acute and subchronic specific neurotoxicity studies (i.e. inclusive of neuropathology) were carried out, and functional observation batteries (FOBs) and motor activity assessments were included in the repeated dose/chronic studies with fluensulfone.  The FOBs and motor activity assessments conducted within the repeated dose/chronic toxicity studies revealed no effects.

In an acute oral neurotoxicity study in rats, groups of 10 male and 10 female Wistar rats were administered single oral doses of 0 (control), 100, 400 and 1200 mg/kg bw of fluensulfone by oral gavage  and observed for 14 days.  No test item-related effects on absolute and relative brain weights were evident, and there were no findings in the nervous system during macroscopic and microscopic pathology examinations.  The LOAEL for general toxicity is 100 mg/kg bw in males and females, based on the general systemic toxicity due to the bolus dose.  The NOAEL for neurotoxicity is 100 mg/kg bw in males and females, based on reduced activity in the functional observation battery and decreased motor activity at 400 mg/kg in absence of any neuropathological finding at any dose level.

In a subchronic dietary neurotoxicity study, groups of 12 male and 12 female RccHan:WIST (SPF) rats received fluensulfone in their diet at concentrations of 0 (control), 100, 500 and 2500 ppm (0, 6, 31, and 153 mg/kg/day in males and 0, 7, 34, and 162 mg/kg/day in females) for at least 90 days.  Treatment-related effects were confined to lower food consumption, body weight and body weight gain in males and females at 2500 ppm. These treatment-related effects were attributed to systemic toxicity, and not to neurotoxicity.  No effects on functional parameters or neurohistopathology were observed. Therefore, the high dose level of 2500 ppm was the `no-observed-effect level' (NOEL) for neurotoxicity associated with dietary exposure, equivalent to 153 mg/kg bw/day in males and 162 mg/kg bw/ day in females.  The no-observed-adverse-effect level (NOAEL) for systemic toxicity was 500 ppm equivalent to 31 mg/kg bw/day for males and 34 mg/kg bw/day for females.

As developmental studies did not indicate that the offspring are more sensitive than the adult, and neuropathological effects were not observed in any of the performed neurotoxicity studies, a developmental neurotoxicity study was considered not necessary.

      7. Immunotoxicity.  Although immunotoxicity endpoints were already included in the 28-day dietary study in rats and mice, fluensulfone was tested also in mice in the 28-day sheep red blood cell assay, to evaluate its immunotoxicity potential. In addition, the entire available data set was examined to check immunotoxicity-related endpoints.  It is concluded that fluensulfone is not an immunotoxic substance.

      8. Animal metabolism. Fluensulfone (labeled at the thiazole and the butene-moieties of the molecule) administered orally to rats at nominal single doses of either 5 mg/kg or 500 mg/kg is rapidly metabolized. The recovery of radioactivity was essentially complete for all groups of rats. The disposition and excretion of radiolabel for males and females were generally similar. There was no indication that the metabolic elimination processes were saturated by the 100-fold increase in dose level, as levels of radiolabel in urine, cage wash, feces, carcass, and gastro-intestinal (GI tract) were similar.

Urine was the major route of excretion and the only source of metabolites at >=5% of the applied radiolabel.  The cage wash contained relatively high levels of radiolabeled metabolites and analysis showed that those metabolites in cage wash and urine were similar.  Low amounts of thiazole sulfonic acid were found in feces, but no other fecal metabolites were >=5% of the applied dose.  Fluensulfone is not a significant residue in either urine or feces.

In addition to investigating metabolism after a single dose, the tissue distribution was studied when the dosing of radioactivity was preceded by 14 days administration of unlabelled material.  The results indicate that distribution is comparable in both cases.

	7. Metabolite toxicology. The acute oral LD50 of fluensulfone metabolite M-3625 was greater than 2000 mg/kg(less than that of the parent fluensulfone).

Metabolite M-3625 was tested for its genotoxic potential in a bacterial reverse gene mutation assay, an in vitro chromosome aberration assay in mammalian cells, and an in vivo micronucleus assay in the bone marrow of rat. No genotoxic properties were identified.

      The acute oral LD50 of fluensulfone metabolite M-3627 (BSA) was greater than 2000 mg/kg bw (less than that of the parent fluensulfone).

Metabolite M-3627 was tested for its genotoxic potential in a bacterial reverse gene mutation assay, an in vitro chromosome aberration assay in mammalian cells, and an in vivo micronucleus assay in the bone marrow of rat. No genotoxic properties were identified.

	8. Endocrine disruption. Evidence from the large available toxicological data set demonstrates that fluensulfone does not exert any adverse effects on thyroid gland, reproductive system and related endocrine organs and adrenal glands.  Therefore, it is concluded that fluensulfone does not possess any endocrine disrupting potential.

C. Aggregate Exposure

	1. Dietary exposure. Acute and chronic dietary (food + water) exposures to fluensulfone have been estimated for the proposed uses on cucurbits and fruiting vegetables.  Drinking water concentrations have been modeled, and the resulting parent-equivalent residues were included in the dietary exposure assessment.  A Tier 1 acute dietary exposure assessment was conducted assuming tolerance-level residues, 100% crop treated and default processing factors.  For chronic dietary exposures, the assessment is partially refined since it relies on average residues and, where available, empirical processing factors, but the results are still conservative due to the assumption of 100% crop treated.

      A summary of the acute and chronic reference doses (RfDs) are given in the table below:

                               Exposure Duration
                                Reference Dose
                                     Basis
                                     Acute
                                 0.033 mg/kg/d
      LOAEL of the acute neurotoxicity study with a safety factor of 300

                                    Chronic
                                 0.014 mg/kg/d
      NOAEL of the rat chronic toxicity study with a safety factor of 100

      Acute Dietary Exposure.  An acute dietary exposure assessment was performed adjusting the parent-equivalent estimated drinking water concentrations (EDWCs). The parent-equivalent EDWCs were assumed to be 150 ppb.  Existing residue data on representative cucurbit and fruiting vegetable crops were translated to all other crops in the cucurbit and fruiting vegetable crop groups using standard EPA procedures.

      Acute dietary (food + water) exposures to fluensulfone were calculated using DEEM-FCID version 2.16.  The reported exposures correspond to the 95th percentile of the exposure distributions, as is appropriate for a Tier 1 acute dietary exposure assessment.  The 95th percentile acute dietary (food + water) exposures are less than the aRfD (0.33 mg/kg/d).  Acute dietary exposures below 100% of the aRfD are reasonably anticipated to result in no harm to exposed populations.  For infants, the most highly exposed subpopulation, 95th percentile acute dietary exposures correspond to 9.2% of the aRfD.  For the general U.S. Population, 95th percentile acute dietary exposures correspond to 3.7% of the aRfD.

      Chronic Dietary Exposure.  A chronic dietary exposure assessment was performed using the parent-equivalent estimated drinking water concentrations (EDWCs).  The parent-equivalent EDWCs were assumed to be 77 ppb. Existing residue data on representative cucurbit and fruiting vegetable crops were translated to all other crops in the cucurbit and fruiting vegetable crop groups using standard EPA procedures.

      Chronic dietary exposures to fluensulfone were calculated using DEEM-FCID version 2.16.  Chronic dietary exposures are less than the cRfD (0.014 mg/kg/d).  Chronic dietary exposures below 100% of the cRfD are reasonably anticipated to result in no harm to exposed populations.  For infants, the most highly exposed subpopulation, chronic dietary exposures correspond to 39.6% of the cRfD.  For the general U.S. Population, chronic dietary exposures correspond to 13.6% of the cRfD.

	i. Food. Exposure to fluensulfone through food is included in the dietary assessment section above.  For food alone, the 95th percentile acute dietary exposures account for just 1.9% and 4.6% of the aRfD for the U.S. population and the most highly exposed subpopulation, respectively. For food alone, the chronic dietary exposures account for just 2.0% and 4.5% of the cRfD for the U.S. population and the most highly exposed subpopulation, respectively.

	ii. Drinking water. Exposure to fluensulfone through water is included in the dietary assessment section above.  The estimated residues in water constitute the majority of total dietary exposures.

	2. Non-dietary exposure. Fluensulfone is currently not registered for use on any residential non-food site.  Therefore, residential exposure to fluensulfone residues will be through dietary exposure only.

D. Cumulative Effects

	Fluensulfone is a member of a new chemical class of nematicides with a specific toxicological profile. It does not share a known toxicological mode of action with other pesticides. Thus, no cumulative effects are foreseen.

E. Safety Determination

	1. U.S. population. Using the conservative exposure assumptions described above and based on the completeness of the toxicity data, it can be concluded that total food and drinking water exposure to fluensulfone from all proposed crop uses will be 3.7% of the aRfD and 13.6% of the cRfD for the overall US population.

	2. Infants and children. Using the conservative exposure assumptions described above and based on the completeness of the toxicity data, it can be concluded that the total acute food and drinking water exposure to fluensulfone from all proposed crop uses will be 9.2% (all infants), 6.90% (children 1-2 yrs), 6.1% (children 3-5 yrs), and 4.30% (6-12 yrs) of the aRfD.  It can be concluded that the total chronic food and drinking water exposure to fluensulfone from all proposed crop uses will be 39.6% (all infants), 21.7% (children 1-2 yrs), 20.3% (children 3-5 yrs), and 13.9% (children 6-12 yrs) of the cRfD.

F. International Tolerances

	No Codex Maximum Residue Levels (MRLs) have been established for residues of fluensulfone on any crops.  There are no established tolerances for fluensulfone on any crops in Canada and Mexico, however, this submission is part of a Global Joint Review application involving Canada and the United States.


[Federal Register Volume 83, Number 220 (Wednesday, November 14, 2018)]
[Proposed Rules]
[Pages 56775-56777]
[FR Doc No: 2018-24815]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2018-0369 FRL-9986-29-Region 5]

Air Plan Approval; Ohio; Ohio Less Than 10 TPY BAT Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve, under the Clean Air Act (CAA), revisions to Ohio's State
Implementation Plan (SIP) as requested by the Ohio Environmental
Protection Agency (OEPA) on May 22, 2018. OEPA has submitted, for
approval, revisions that exempt sources that emit less than 10 tons per
year (tpy) from the need to employ Best Available Technology (BAT). EPA
is proposing to approve these revisions because they are consistent
with Federal regulations governing state permit programs.

DATES: Comments must be received on or before December 14, 2018.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2018-0369 at http://www.regulations.gov, or via email to
[email protected]. For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the For Further Information Contact section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Richard Angelbeck, Environmental
Scientist, Air Permits Section, Air Programs Branch (AR-18J),
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. What revisions did OEPA submit?
II. Do the revisions comply with section 110(l) of the Clean Air
Act?
III. What action is EPA taking?
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. What revisions did OEPA submit?

    On May 22, 2018, OEPA submitted a SIP revision to Ohio
Administrative Code (OAC) rule 3745-31-05(A)(3)(a)(ii), which is its
BAT rule. This revision exempts the smaller emitting sources, those
that emit less than 10 tpy of each criteria pollutant, from the need to
employ BAT. OEPA's less than 10 tpy BAT exemption is currently in
OEPA's OAC 3745-31-05(A)(3)(a)(ii) and reads: ``BAT is not required if
the air contaminant source was installed or modified on or after August
3, 2006 and has the potential to emit (PTE), taking into account air
pollution controls installed on the source, less than ten tons per year
of emissions of an air contaminant or precursor of an air contaminant
for which a national ambient air quality standard has been adopted
under the Clean Air Act.''
    Ohio's Federally approved construction program, OAC 3745-31
(``Permits to Install New Sources of Pollution'') provides the
authority for OEPA to issue Permits to Install (PTI) to new sources of
air pollution or modifications to existing sources of air pollution.
For attainment areas, the program was conditionally approved into
Ohio's SIP on October 10, 2001 (66 FR 51570), and fully approved on
January 22, 2003 (68 FR 2909). For nonattainment areas, the program was
fully approved on January 10, 2002 (68 FR 1366). On February 20, 2013,
OEPA's SIP was revised (78 FR 28547) to combine the PTI and Permit to
Operate (PTO) programs into a single Permit to Install and Operate
(PTIO) program so that a minor source not subject to title V of the
Clean Air Act in Ohio would be issued a single PTIO instead of a PTI
and a PTO permit.
    On August 3, 2006, the Ohio General Assembly passed Senate Bill 265
(SB 265) which required OEPA to modify several of its BAT rules. OEPA's
BAT is an air permitting mechanism to help control emissions in minor
air permits. BAT can be any combination of work practices, air
pollution control devices, raw material specifications, throughput
limitations, source design characteristics, and OEPA does an evaluation
of the annualized cost per ton of air pollutant removed when
determining BAT. One of the changes implemented was the less than 10
tpy BAT exemption. To implement the SB 265 changes, OEPA adopted
revisions under OAC Chapter 3745-31-05(A)(3)(b) on November 20, 2006,
which became effective on December 1, 2006. On January 18, 2008, OEPA
requested that EPA approve this rule language as a revision to Ohio's
SIP. EPA responded with a June 5, 2008 letter to OEPA indicating that
the request was incomplete due to a lack of a CAA section 110(l)
demonstration, thus returning the request back to OEPA. On June 2,
2008, OEPA moved the language in OAC rule 3745-31-05 from paragraph
(A)(3)(b) to (A)(3)(a)(ii) which became effective at the state level on
June 30, 2008. The rule language contained in OAC rule 3745-31-
05(A)(3)(a)(ii) was carried over in OAC rule 3745-31-05, which was
adopted on April 20, 2016, and became effective at the state level as
of May 1, 2016, and is what OEPA is now requesting for EPA approval as
a revision to its SIP. EPA considered this May 22, 2018 submittal to be
complete.

II. Do the revisions comply with section 110(l) of the Clean Air Act?

    OEPA's May 22, 2018 SIP revision submittal included a 110(l)
demonstration. This demonstration included an extensive analysis to
show the impact that the less than 10 tpy BAT exemption would have on
emissions. This analysis evaluated over 400 permits, representing more
than 80

source classification codes and 36 different types of categories of
sources. Each criteria pollutant was evaluated and then a comparison
was made between the emission limit that would occur if BAT applied and
if BAT did not apply to the less than 10 tpy sources. The analysis
concludes that there would be a negligible increase in emissions due to
the less than 10 tpy BAT exemption.
    The 110(l) demonstration included a quantitative and qualitative
analysis. The analysis estimated an emission increase of 36.89 tpy of
volatile organic compounds (VOC) emissions in attainment areas and
nonattainment areas, combined, when applying the less than 10 tpy BAT
exemption compared to BAT-based emissions. That increase in VOC
emissions represented a very small amount (0.12%) of the total actual
point source VOC emissions reported for that year, 2010 in Ohio.
    The 110(l) analysis estimated the VOC emission increases in the
Ohio nonattainment areas combined, as well as to each of the three Ohio
ozone nonattainment areas (Cleveland, Cincinnati, Columbus). This
analysis links the estimated VOC increases to each of the Ohio ozone
nonattainment areas and demonstrates that each nonattainment area will
not be negatively impacted by the estimated increase in emissions. The
analysis showed an estimated increase of 25.53 tpy of VOC in Ohio
nonattainment areas which represented 0.2% of the 2010 total VOC
emissions in Ohio. OEPA's analysis also quantified the estimated VOC
increases in the three Ohio nonattainment areas: 18.65 tpy in the
Cincinnati area, 4.88 tpy in the Cleveland/Akron/Lorain area, and 0 tpy
in the Columbus area. OEPA's analysis further broke out the 18.65 tpy
Cincinnati nonattainment area VOC emission increase to the following
two areas: 13 tpy increase in Hamilton County, and 5.6 tpy in Butler
County.
    To address the VOC emission increases in the Cincinnati and
Cleveland nonattainment areas, OEPA opted to use VOC emission offsets
to mitigate any possibility of adverse air quality impact that may
result from the small increase in VOC emissions. These relied-upon
emission offsets are from permanently shut down emission units at one
facility in Ashtabula (4.88 tpy offset VOCs) and one facility in
Hamilton (18.65 tpy offset VOCs) counties located in the Cincinnati and
Cleveland nonattainment areas, respectively. The 4.88 tpy offset VOCs
in Ashtabula County are from the permanently shut down emission unit
R010 at the RMC USA Inc. facility (Facility ID<PHONE_NUMBER>), the
emission unit was permanently shut down on 7/16/2014. The 18.65 tpy
offset VOCs in Hamilton County are from the permanently shut down
emission unit P001 at the Rock-Tenn Converting Co. facility (Facility
ID<PHONE_NUMBER>), the emission unit was permanently shut down on 11/21/
2014. This 18.65 tpy offset VOCs is to offset the possible VOC
increases in Hamilton and Butler Counties, combined. The VOC emission
reductions have been verified and validated through OEPA's Stars II
system and are considered creditable since they are surplus,
quantifiable, permanent and federally enforceable. OEPA maintains a
database of all emission reductions used for purpose of CAA 110(l)
demonstrations and these VOC reductions will be tracked within this
database to ensure they cannot be used again. OEPA has committed to
permanently retire the 25.33 tpy of VOC emissions upon EPA's approval
of this SIP revision and EPA's proposed approval of this SIP revision
is based on that commitment. The VOC emission reductions from the
permanent emission unit shut downs will offset the predicted VOC
emissions increase in these VOC nonattainment areas resulting from the
less than 10 tpy BAT exemption and ensure that plans to bring the VOC
nonattainment with the NAAQS are not compromised and thus it is
expected there will be no adverse impact on air quality.
    OEPA's 110(l) analysis demonstrated that the air quality will not
be negatively impacted due to the small increase in emissions as result
of the less than 10 tpy BAT exemption. OEPA's 110(l) analysis
demonstrated that the VOC emission offsets from the shutdown emission
units at the two facilities will counterbalance the estimated emission
increase in VOC emissions due to the less than 10 tpy BAT exemption and
will not have a negative impact on air quality nor cause backsliding
from Ohio's reasonable further progress plans. OEPA will formally
retire the VOC emission offsets in order to receive final approval of
this SIP revision. OEPA's 110(l) analysis also demonstrated that the
small increase in VOC emissions in Ohio's ozone attainment areas will
not have a negative impact on air quality because the increase in VOC
emissions is very small compared to the VOC emissions emitted state-
wide.

III. What action is EPA taking?

    EPA is proposing approval, into the SIP, of the rule revision to
OAC 3745-31-05(A)(3)(a)(ii) that OEPA submitted on May 22, 2018. The
SIP revision submitted, described in section I, above, is consistent
with Federal regulations governing state permitting programs. See
section II above. EPA is also soliciting comment on this proposed
approval.

IV. Incorporation by Reference

    In this rule, EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, EPA is proposing to incorporate by
reference revisions to Ohio Administrative Code 3745-31-
05(A)(3)(a)(ii), effective on May 1, 2016. EPA has made, and will
continue to make, these documents generally available through
www.regulations.gov and at the EPA Region 5 Office (please contact the
person identified in the For Further Information Contact section of
this preamble for more information).

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);

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

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: October 30, 2018.
Cathy Stepp,
Regional Administrator, Region 5.
[FR Doc. 2018-24815 Filed 11-13-18; 8:45 am]
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