[Federal Register Volume 87, Number 155 (Friday, August 12, 2022)]
[Notices]
[Pages 49860-49861]
[FR Doc No: 2022-17349]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-1494 (Formerly FDA-2000-D-0135)]

International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products;
Effectiveness of Anthelmintics: Specific Recommendations for Canines
(Revision 1); Draft Guidance for Industry; Availability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the availability of a draft guidance for industry GFI #111 (VICH
GL19(R1)) entitled ``Effectiveness of Anthelmintics: Specific
Recommendations for Canines (Revision 1).'' This draft guidance has
been developed for veterinary use by the International Cooperation on
Harmonisation of Technical Requirements for Registration of Veterinary
Medicinal Products (VICH). This revision clarifies the definition of
adequate infection in individual animals, updates considerations for
field studies, and makes additional clarifying changes.

DATES: Submit either electronic or written comments on the draft
guidance by October 11, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-D-1494 for ``Effectiveness of Anthelmintics: Specific
Recommendations for Canines (Revision 1).'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting

of comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Aim[eacute]e Phillippi-Taylor, Center
for Veterinary Medicine (HFV-114), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
GFI #111 (VICH GL19(R1)) entitled ``Effectiveness of Anthelmintics:
Specific Recommendations for Canines (Revision 1).'' It should be read
in conjunction with GFI #90 (VICH GL7), ``Effectiveness of
Anthelmintics: General Recommendations,'' which should be referred to
for discussion of broad aspects for providing pivotal data to
demonstrate product anthelmintic effectiveness. The purpose of this
guidance is: (1) to be more specific for certain specific canine issues
not discussed in GFI #90 (VICH GL7); (2) to highlight differences with
GFI #90 (VICH GL7) on effectiveness data recommendations; and (3) to
give explanations for disparities with GFI #90 (VICH GL7). This
revision clarifies the definition of adequate infection in individual
animals, updates considerations for field studies, and makes additional
clarifying changes.
    FDA has participated in efforts to enhance international
harmonization and is committed to seeking scientifically based
harmonized technical procedures for pharmaceutical development. One of
the goals of harmonization is to identify, and then reduce, differences
in technical requirements for drug development among regulatory
agencies in different countries.
    FDA has actively participated in the International Council for
Harmonisation of Technical Requirements for Pharmaceuticals for Human
Use to develop harmonized technical requirements for the approval of
human pharmaceutical and biological products among the European Union,
Japan, and the United States. The VICH is a parallel initiative for
veterinary medicinal products. The VICH is concerned with developing
harmonized technical requirements for the approval of veterinary
medicinal products in the European Union, Japan, and the United States,
and includes input from both regulatory and industry representatives.
    The VICH Steering Committee is composed of member representatives
from the European Commission and European Medicines Agency;
AnimalhealthEurope; FDA--Center for Veterinary Medicine and U.S.
Department of Agriculture--Center for Veterinary Biologics; the U.S.
Animal Health Institute; the Japanese Ministry of Agriculture, Forestry
and Fisheries; and the Japanese Veterinary Products Association.
    There are 10 observers to the VICH Steering Committee: one
representative from government and one representative from industry of
Australia, New Zealand, Canada, South Africa, and the United Kingdom.
The World Organisation for Animal Health is an associate member of the
VICH. The VICH Secretariat, which coordinates the preparation of
documentation, is provided by HealthforAnimals.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on
``Effectiveness of Anthelmintics: Specific Recommendations for Canines
(Revision 1).'' 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. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 514 have been approved under OMB control
number 0910-0032.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: August 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17349 Filed 8-11-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 189 (Monday, October 2, 2023)]
[Notices]
[Pages 67846-67851]
[FR Doc No: 2023-21625]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-98533; File No. SR-MEMX-2023-24]

Self-Regulatory Organizations; MEMX LLC; Notice of Filing and
Immediate Effectiveness of a Proposed Rule Change To Amend the
Exchange's Fee Schedule

September 26, 2023.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on September 15, 2023, MEMX LLC (``MEMX'' or the ``Exchange'') filed
with the Securities and Exchange Commission (``SEC'' or ``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

    The Exchange is filing with the Commission a proposed rule change
to amend the Exchange's fee schedule applicable to Members \3\ pursuant
to Exchange Rules 15.1(a) and (c). Specifically, the Exchange proposes
to adopt transaction fees (``Transaction Fees''), routing fees
(``Routing Fees''), and definitions (``Definitions'') within the MEMX
Options Fee Schedule (the ``Options Fee Schedule''). The Transaction
Fees section of the Options Fee Schedule would establish transaction
fees and rebates applicable to Options Members trading on the
Exchange's options trading platform (such platform, ``MEMX Options''
and such Members, ``Options Members''). The Routing Fees section of the
Options Fee Schedule would establish fees for Options Members who route
their orders to away exchanges. The Definitions section of the Options
Fee Schedule would define and clarify terms used in the Options Fee
Schedule. The Exchange proposes to implement the changes to the Options
Fee Schedule pursuant to this proposal on September 20, 2023. The text
of the proposed rule change is provided in Exhibit 5.
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    \3\ See Exchange Rule 1.5(p).
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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 purpose of the proposed rule change is to (i) establish
transaction rebates and fees applicable to all Options Members trading
on MEMX Options; (ii) establish routing fees applicable to all Options
Members trading on MEMX Options who route orders to away exchanges; and
(iii) define and clarify terms used in the Options Fee Schedule.
Transaction Fees
    The proposed Transaction Fees section of the Options Fee Schedule
sets forth transaction rebates and fees for executions on MEMX Options.
MEMX Options will operate a ``Maker-Taker'' model whereby it provides
rebates to Options Members that provide liquidity and charges fees to
those that remove liquidity, as further described below. The proposed
rebates and fees vary depending on whether a transaction was executed
in a customer capacity (``Customer'') \4\ or in a non-customer capacity
(``Non-Customer'') \5\, whether the underlying security of the
applicable option is in the Penny Pilot Program

(``Penny options'') or not in the Penny Pilot Program (``Non-Penny
options''), and, finally, whether the transaction adds or removes
liquidity from the MEMX Options Book.
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    \4\ Customer capacity applies to any order for the account of a
Priority Customer. ``Priority Customer'' means any person or entity
that is neither a broker or dealer in securities nor a Professional.
See Rule 16.1 of the MEMX Rulebook.
    \5\ Non-Customer capacity applies to any transaction that is not
a Customer order.
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    The Exchange will provide fee qualifiers to distinguish between
Customer transactions and Non-Customer transactions.\6\ MEMX Options
will provide Fee Codes to distinguish between transactions in Penny
options and transactions in Non-Penny options.\7\ MEMX Options will
also provide Fee Codes to distinguish between transactions that add
liquidity to the MEMX Options Book and transactions that remove
liquidity from the MEMX Options Book.\8\
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    \6\ MEMX Options will provide fee qualifier ``c'' for Customer
transactions. MEMX Options will provide fee qualifier ``m'' for
market maker transactions, fee qualifier ``p'' for professional
transactions, fee qualifier ``f'' for firm transactions, fee
qualifier ``a'' for away market maker transactions, and fee
qualifier ``b'' for broker-dealer transactions. Each of market maker
transactions, professional transactions, firm transactions, away
market maker transactions, and broker-dealer transactions shall be
referred to as ``Non-Customer'' transactions. Fee qualifiers will be
provided by the Exchange on the monthly invoices provided to Options
Members.
    \7\ MEMX Options will provide Fee Code ``P'' for transactions in
Penny options and Fee Code ``N'' for transactions in Non-Penny
options. Fee Codes will be provided by the Exchange on the monthly
invoices provided to Options Members.
    \8\ MEMX Options will provide Fee Code ``D'' for transactions
which add liquidity to the MEMX Options Book, and Fee Code ``R'' for
transactions that remove liquidity from the MEMX Options Book. Fee
Codes will be provided by the Exchange on the monthly invoices
provided to Options Members.
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    Options Members shall be assessed lower transaction fees and
smaller rebates for order executions in Penny options than for order
executions in Non-Penny options, for which Members will be assessed
higher transaction fees and larger rebates. As noted above, Options
Members shall be assessed fees for removing liquidity from the MEMX
Options Book and provided rebates for adding liquidity to the MEMX
Options Book. At this time, the Exchange will not differentiate between
fees charged and rebates assessed for different types of Non-Customer
transactions; instead, all Non-Customer transactions (i.e.,
transactions for the accounts of market makers, professionals, firms,
away market makers, or broker dealers) will be assessed the same fees
and rebates.
    The Fee Codes and fee qualifiers will be used to make clear to
Members what rebates were provided to them and which fees were
assessed.\9\ The Exchange believes that designating the Fee Codes will
make clear the different types of fees and rebates passed back to
Members on execution reports and will be useful for the Exchange in
considering potential pricing modifications as it continues to evaluate
its pricing structure on an ongoing basis after the launch of MEMX
Options. The Exchange's Fee Codes and fee qualifiers will assist the
Exchange and Options Members with financial planning, tracking, and
reconciliation of invoices generated by the Exchange.
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    \9\ For example, for a Customer order in a Penny option that
removes liquidity from the MEMX Book, the Exchange would pass back
the Fee Code RcP. As another example, for a Non-Customer Away Market
Maker order in a Non-Penny option that adds liquidity to the MEMX
Book, the Exchange would pass back the Fee Code DaN.
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    Transactions for Customer accounts in Penny options that remove
liquidity from the MEMX Book will be assessed a fee of $0.46 per
contract. Transactions for Non-Customer accounts in Penny options that
remove liquidity will be assessed a fee of $0.50 per contract.
Transactions for Customer accounts in Non-Penny options that remove
liquidity from the MEMX Book will be assessed a fee of $0.85 per
contract. Finally, transactions for Non-Customer accounts in Non-Penny
options that remove liquidity will be assessed a fee of $1.10 per
contract. The purpose of the proposed transaction fees is to assess
right-sized fees for orders that remove liquidity from the Exchange.
    Transactions for Customer accounts in Penny options that add
liquidity to the MEMX Options Book will receive a rebate of $0.49 per
contract. Transactions for Non-Customer accounts in Penny options that
add liquidity will receive a rebate of $0.45 per contract. Transactions
for Customer accounts in Non-Penny options that add liquidity to the
MEMX Options Book will receive a rebate of $1.04 per contract. Finally,
transactions for Non-Customer accounts in Non-Penny options that add
liquidity will receive a rebate of $0.80 per contract. The purpose of
the proposed transaction rebates is to provide right-sized incentives
for Options Members to trade on the Exchange and to incentivize order
flow to be directed to the Exchange.
    The Exchange does not initially propose to charge tiered fees or
provide tiered rebates according to the volume of orders submitted to
MEMX Options. Accordingly, all fees and rebates described above are
applicable to all Options Members regardless of the overall volume of
an Options Member's activities on MEMX Options.
Routing Fees
    The Exchange proposes to assess Routing Fees on orders routed to
other options exchanges. The amount of the applicable fee will be based
on whether the order is for a Penny or Non-Penny option. At this time,
the Exchange will not charge different routing fees according to the
capacity of the order. The Exchange will charge a fee of $0.60 for
Penny options routed to another options exchange and $1.20 for Non-
Penny options routed to another options exchange.
    The purpose of the proposed Routing Fees is to recoup costs
incurred by the Exchange when routing orders to other options exchanges
on behalf of Options Members. In determining its proposed Routing Fees,
the Exchange took into account transaction fees assessed by other
options exchanges, the Exchange's projected clearing costs, and the
projected administrative, regulatory, and technical costs associated
with routing orders to other options exchanges. The Exchange will use
its affiliated broker-dealer, MEMX Execution Services, to route orders
to other options exchanges or to other broker-dealers that will route
such orders to other options exchanges. Routing services offered by the
Exchange and its affiliated broker-dealer are completely optional and
market participants can readily select between various providers of
routing services, including other exchanges and broker-dealers. The
proposed structure for routing fees is similar to the fee structure in
place for routing at various other exchanges.\10\ The Exchange believes
that the proposed Routing Fees would enable the Exchange to recover the
costs it incurs to route orders to away markets after taking into
account the other costs associated with routing orders to other options
exchanges.
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    \10\ See Exchange Act Release Nos. 97896 (July 13, 2023), 88 FR
46313 (July 19, 2023) (SR-PEARL-2023-30); 97901 (July 13, 2023), 88
FR 46202 (July 19, 2023) (SR-EMERALD-2023-15); 85591 (April 10,
2019), 84 FR 15645 (April 16, 2019) (SR-CboeBZX-2019-024); 91677
(April 26, 2021), 86 FR 22989 (April 30, 2021) (SR-NASDAQ-2021-021);
and 97234 (March 31, 2023), 88 FR 20589 (April 6, 2023) (SR-
NYSEARCA-2023-28).
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Definitions
    The Exchange has included a Definitions section within the Options
Fee Schedule. The purpose of the Definitions section is to streamline
the Options Fee Schedule by placing many of the defined terms used in
the Options Fee Schedule in one location. The Definitions section
defines the terms ``Penny Program Securities'', ``Away Market Maker'',
``Broker Dealer'', ``Customer'', ``Firm'', ``Market Maker'', and
``Professional''. Many of the defined terms are also defined in the
Exchange Rules, particularly in Exchange Rule 16.1. The Exchange notes
that other exchanges have Definitions sections in

their respective fee schedules,\11\ and the Exchange believes that
including such section makes the Options Fee Schedule more readable and
user-friendly.
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    \11\ See, e.g., the MIAX Pearl Options Fee Schedule, available
at https://www.miaxglobal.com/sites/default/files/page-files/MIAX_Pearl_Options_Fee_Schedule_08082023.pdf; the CBOE BZX Options
Fee Schedule, available at https://www.cboe.com/us/options/membership/fee_schedule/bzx/; and the Nasdaq Options Market Fee
Schedule, available at https://listingcenter.nasdaq.com/rulebook/nasdaq/rules/nasdaq-options-7.
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2. Statutory Basis
    The Exchange believes that its proposal to amend its Options Fee
Schedule is consistent with the provisions of Section 6 of the Act,\12\
in general, and with Sections 6(b)(4) and 6(b)(5) of the Act,\13\ in
particular, in that it provides for the equitable allocation of
reasonable dues, fees and other charges among Options Members and other
persons using its facilities. The Exchange also believes the proposal
furthers the objectives of Section 6(b)(5) of the Act in that it is
designed to promote just and equitable principles of trade, 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 and is not designed to permit unfair discrimination
between customers, issuers, brokers, or dealers.
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    \12\ 15 U.S.C. 78f.
    \13\ 15 U.S.C. 78f(b)(4) and (5).
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    Upon its launch, MEMX Options will operate in a highly fragmented
and 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, and the
Exchange represents only a small percentage of the overall market. The
Commission and the courts have repeatedly expressed their preference
for competition over regulatory intervention in determining prices,
products, and services in the securities markets. 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.'' \14\
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    \14\ Securities Exchange Act Release No. 51808 (June 9, 2005),
70 FR 37496, 37499 (June 29, 2005).
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    Accordingly, competitive forces constrain the Exchange's
transaction fees and rebates, and market participants can readily trade
on competing venues if they deem pricing levels at those other venues
to be more favorable. The Exchange believes the proposal reflects a
reasonable and competitive pricing structure which the Exchange
believes would promote price discovery and enhance liquidity and market
quality on the Exchange to the benefit of all Members and market
participants.
    The Exchange believes that it is appropriate, reasonable, and
consistent with the Act to charge $0.46 for orders for Customer
accounts that remove liquidity in Penny options, because it is
comparable to the transaction fees charged by other exchanges for
Customer transactions that remove liquidity in Penny options.\15\ The
Exchange further believes that this fee is equitably allocated and not
unfairly discriminatory because it applies equally to all Options
Members.
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    \15\ For example, the MIAX Pearl Options trading fee schedule on
its public website reflects a transaction fee ranging from $0.47-
$0.48 for Customer transactions that remove liquidity in Penny
options; see https://www.miaxglobal.com/sites/default/files/page-files/MIAX_Pearl_Options_Fee_Schedule_08082023.pdf. The Cboe BZX
Options trading fee schedule on its public website reflects a
transaction fee ranging from $0.46-$0.48 for Customer transactions
that remove liquidity in Penny options; see https://www.cboe.com/us/options/membership/fee_schedule/bzx/. The Nasdaq Options Market
trading fee schedule on its public website reflects a transaction
fee of $0.49 for Customer transactions that remove liquidity in
Penny options; see https://listingcenter.nasdaq.com/rulebook/nasdaq/rules/nasdaq-options-7. Additionally, the NYSE Arca Options trading
fee schedule on its public website reflects a transaction fee of
$0.46-$0.49 for Customer transactions that remove liquidity in Penny
options; see https://www.nyse.com/publicdocs/nyse/markets/arca-options/NYSE_Arca_Options_Fee_Schedule.pdf.
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    The Exchange believes that it is appropriate, reasonable, and
consistent with the Act to charge $0.50 for orders for Non-Customer
accounts in Penny options that remove liquidity because it is
comparable to the transaction fee charged by other exchanges for Non-
Customer transactions in Penny options that remove liquidity.\16\ The
Exchange further believes that this fee is equitably allocated and not
unfairly discriminatory because it applies equally to all Options
Members.
---------------------------------------------------------------------------

    \16\ For example, the MIAX Pearl Options trading fee schedule on
its public website reflects a transaction fee of $0.50 for Non-
Customer transactions that remove liquidity in Penny options; see
https://www.miaxglobal.com/sites/default/files/page-files/MIAX_Pearl_Options_Fee_Schedule_08082023.pdf. Per the Cboe BZX
Options trading fee schedule on its public website, transactions for
the accounts of market maker and professional customers that remove
liquidity in Penny options are assessed a $0.47-$0.50 fee and
transactions for the accounts of broker dealers that remove
liquidity in Penny options are assessed a $0.46-$0.50 fee; see
https://www.cboe.com/us/options/membership/fee_schedule/bzx/. Per
the Nasdaq Options Market trading fee schedule on its public
website, transactions for the accounts of firms, broker-dealers, and
market makers that remove liquidity in Penny options are assessed a
fee of $0.50 and transactions for the accounts of professional
customers that remove liquidity in Penny options are assessed a fee
of $0.49; see https://listingcenter.nasdaq.com/rulebook/nasdaq/rules/nasdaq-options-7. Lastly, per the NYSE Arca Options trading
fee schedule on its public website, transactions for the accounts of
market makers, broker-dealers, and professional customers that
remove liquidity in Penny options are assessed a fee of $0.50; see
https://www.nyse.com/publicdocs/nyse/markets/arca-options/NYSE_Arca_Options_Fee_Schedule.pdf.
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    The Exchange believes that it is appropriate, reasonable, and
consistent with the Act to charge $0.85 for orders for Customer
accounts in Non-Penny options that remove liquidity because it is
comparable to the transaction fees charged by other exchanges for
Customer transactions in Non-Penny options that remove liquidity.\17\
The Exchange further believes that this fee is equitably allocated and
not unfairly discriminatory because it applies equally to all Options
Members.
---------------------------------------------------------------------------

    \17\ For example, the MIAX Pearl Options trading fee schedule on
its public website reflects a transaction fee of $0.85 for Customer
transactions that remove liquidity in Non-Penny options; see https://www.miaxglobal.com/sites/default/files/page-files/MIAX_Pearl_Options_Fee_Schedule_08082023.pdf. Similarly, the Cboe
BZX Options trading fee schedule on its public website also reflects
a $0.85 transaction fee for Customer transactions that remove
liquidity in Non-Penny options; see https://www.cboe.com/us/options/membership/fee_schedule/bzx/. Similarly, the Nasdaq Options Market
trading fee schedule on its public website also reflects a $0.85
transaction fee for Customer transactions that remove liquidity in
Non-Penny options; see https://listingcenter.nasdaq.com/rulebook/nasdaq/rules/nasdaq-options-7. Lastly and similarly, the NYSE Arca
Options trading fee schedule on its public website reflects a $0.85
transaction fee for Customer transactions that remove liquidity in
Non-Penny options; see https://www.nyse.com/publicdocs/nyse/markets/arca-options/NYSE_Arca_Options_Fee_Schedule.pdf.
---------------------------------------------------------------------------

    The Exchange believes that it is appropriate, reasonable, and
consistent with the Act to charge $1.10 for orders in Non-Customer
accounts in Non-Penny options that remove liquidity because it is
comparable to the transaction fees charged by other exchanges for Non-
Customer transactions in Non-Penny options that remove liquidity.\18\
The Exchange

further believes that this fee is equitably allocated and not unfairly
discriminatory because it applies equally to all Options Members.
---------------------------------------------------------------------------

    \18\ For example, per the MIAX Pearl Options trading fee
schedule on its public website, transactions for the accounts of
market makers that remove liquidity in Non-Penny options are
assessed a $1.07-$1.10 fee and transactions for the accounts of
professional customers, firms, and broker-dealers that remove
liquidity in Non-Penny options are assessed a $1.09-$1.10 fee; see
https://www.miaxglobal.com/sites/default/files/page-files/MIAX_Pearl_Options_Fee_Schedule_08082023.pdf. Per the Cboe BZX
Options trading fee schedule on its public website, transactions for
the accounts of market makers, firms, broker-dealers, and
professional customers that remove liquidity in Non-Penny options
are assessed a $1.07-$1.10 fee; see https://www.cboe.com/us/options/membership/fee_schedule/bzx/. Per the Nasdaq Options Market trading
fee schedule on its public website, transactions for the accounts of
market makers, broker-dealers, and firms that remove liquidity in
Non-Penny options are assessed a $1.10 fee and transactions for the
accounts of professional customers that remove liquidity in Non-
Penny options are assessed a $0.85 fee; see https://listingcenter.nasdaq.com/rulebook/nasdaq/rules/nasdaq-options-7.
Lastly, per the NYSE Arca Options trading fee schedule on its public
website, transactions for the accounts of market makers, firms,
broker-dealers, and professional customers that remove liquidity in
Non-Penny options are assessed a $1.10 fee; see https://www.nyse.com/publicdocs/nyse/markets/arca-options/NYSE_Arca_Options_Fee_Schedule.pdf.
---------------------------------------------------------------------------

    The Exchange believes that it is appropriate, reasonable, and
consistent with the Act to provide a rebate of $0.49 for orders for
Customer accounts in Penny options that add liquidity because it is
comparable to the rebate provided by other exchanges for Customer
transactions in Penny options that add liquidity.\19\ The Exchange
further believes that this rebate is equitably allocated and not
unfairly discriminatory because all Options Members are equally
eligible for the rebate. The Exchange believes that the rebate is
reasonably designed to attract order flow to MEMX Options, which the
Exchange believes would promote price discovery, enhance liquidity and
market quality, and contribute to a more robust and well-balanced
market ecosystem on the Exchange to the benefit of all Members and
market participants.
---------------------------------------------------------------------------

    \19\ For example, the MIAX Pearl Options trading fee schedule on
its public website reflects a rebate ranging from $0.25-$0.52 for
Customer transactions that add liquidity in Penny options; see
https://www.miaxglobal.com/sites/default/files/page-files/MIAX_Pearl_Options_Fee_Schedule_08082023.pdf. The Cboe BZX Options
trading fee schedule on its public website reflects a rebate ranging
from $0.25-$0.53 for Customer transactions that add liquidity in
Penny options; see https://www.cboe.com/us/options/membership/fee_schedule/bzx/. The Nasdaq Options Market trading fee schedule on
its public website reflects a rebate ranging from $0.20-$0.48 for
Customer transactions that add liquidity in Penny options; see
https://listingcenter.nasdaq.com/rulebook/nasdaq/rules/nasdaq-options-7.
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    The Exchange believes that it is appropriate, reasonable, and
consistent with the Act to provide a rebate of $0.45 for orders for
Non-Customer accounts in Penny options that add liquidity because it is
comparable to the rebate provided by other exchanges for Non-Customer
transactions in Penny options that add liquidity.\20\ The Exchange
further believes that this rebate is equitably allocated and not
unfairly discriminatory because all Options Members are equally
eligible for the rebate. The Exchange believes that the rebate is
reasonably designed to attract order flow to MEMX Options, which the
Exchange believes would promote price discovery, enhance liquidity and
market quality, and contribute to a more robust and well-balanced
market ecosystem on the Exchange to the benefit of all Members and
market participants.
---------------------------------------------------------------------------

    \20\ For example, per the MIAX Pearl Options trading fee
schedule on its public website, transactions for the accounts of
market makers that add liquidity in Penny options with a Priority
Customer on the contra side are provided a $0.22-$0.46 rebate, and
transactions for the accounts of professional customers and firms
that add liquidity in Penny options with a non-Priority Customer on
the contra side are provided a $0.25-$0.48 rebate; see https://www.miaxglobal.com/sites/default/files/page-files/MIAX_Pearl_Options_Fee_Schedule_08082023.pdf. Per the Cboe BZX
Options trading fee schedule on its public website, transactions for
the accounts of market makers that add liquidity in Penny options
are provided a $0.29-$0.38 rebate, transactions for the accounts of
professional customers that add liquidity in Penny options are
provided a $0.25-$0.48 rebate, and transactions for the account of
firms and broker-dealers that add liquidity in Penny options are
provided a $0.25-$0.46 rebate; see https://www.cboe.com/us/options/membership/fee_schedule/bzx/. Per the Nasdaq Options Market trading
fee schedule on its public website, transactions for the accounts of
market makers that add liquidity in Penny options are provided a
$0.20-$0.48 rebate, and transactions for the accounts of
professional customers that add liquidity in Penny options are
provided a $0.20-$0.47 rebate; see https://listingcenter.nasdaq.com/rulebook/nasdaq/rules/nasdaq-options-7.
---------------------------------------------------------------------------

    The Exchange believes that it is appropriate, reasonable, and
consistent with the Act to provide a rebate of $1.04 for orders for
Customer accounts in Non-Penny options that add liquidity because it is
comparable to the rebate provided by other exchanges for Customer
transactions in Non-Penny options that add liquidity.\21\ The Exchange
further believes that this rebate is equitably allocated and not
unfairly discriminatory because all Options Members are equally
eligible for the rebate. The Exchange believes that the rebate is
reasonably designed to attract order flow to MEMX Options, which the
Exchange believes would promote price discovery, enhance liquidity and
market quality, and contribute to a more robust and well-balanced
market ecosystem on the Exchange to the benefit of all Members and
market participants.
---------------------------------------------------------------------------

    \21\ For example, per the MIAX Pearl Options trading fee
schedule on its public website, Customer transactions that add
liquidity in Non-Penny options are provided a $0.85-$1.04 rebate;
see https://www.miaxglobal.com/sites/default/files/page-files/MIAX_Pearl_Options_Fee_Schedule_08082023.pdf. Per the Cboe BZX
Options trading fee schedule on its public website, Customer
transactions that add liquidity in Non-Penny options are provided a
$0.85-$1.05 rebate; see https://www.cboe.com/us/options/membership/fee_schedule/bzx/. Per the Nasdaq Options Market trading fee
schedule on its public website, Customer transactions that add
liquidity in Non-Penny options are provided a $0.80-$1.10 rebate;
see https://listingcenter.nasdaq.com/rulebook/nasdaq/rules/nasdaq-options-7. Lastly, per the NYSE Arca Options trading fee schedule on
its public website, Customer transactions that add liquidity in Non-
Penny options are provided a $0.75 rebate; see https://www.nyse.com/publicdocs/nyse/markets/arca-options/NYSE_Arca_Options_Fee_Schedule.pdf.
---------------------------------------------------------------------------

    The Exchange believes that it is appropriate, reasonable, and
consistent with the Act to provide a rebate of $0.80 for orders for
Non-Customer accounts in Non-Penny options that add liquidity because
it is comparable to the rebate provided by other exchanges for Non-
Customer transactions in Non-Penny options that add liquidity.\22\ The
Exchange further believes that this rebate is equitably allocated and
not unfairly discriminatory because all Options Members are equally
eligible for the rebate. The Exchange believes that the rebate is
reasonably designed to attract order flow to MEMX Options, which the
Exchange believes would promote price discovery, enhance liquidity and
market quality, and contribute to a more robust and well-balanced
market ecosystem on the Exchange to the benefit of all Members and
market participants.
---------------------------------------------------------------------------

    \22\ For example, per the MIAX Pearl Options trading fee
schedule on its public website, transactions for the accounts of
market makers that add liquidity in Non-Penny options are provided a
$0.30-$0.85 rebate and transactions for the accounts of professional
customers and firms that add liquidity in Non-Penny options are
provided a $0.30-$0.85 rebate; see https://www.miaxglobal.com/sites/default/files/page-files/MIAX_Pearl_Options_Fee_Schedule_08082023.pdf. Per the Cboe BZX
Options trading fee schedule on its public website, transactions for
the accounts of market makers that add liquidity in Non-Penny
options are provided a $0.40-$0.88 rebate, transactions for the
accounts of professional customers that add liquidity in Non-Penny
options are provided a $0.65 rebate, transactions for the accounts
of away market makers that add liquidity in Non-Penny options are
provided a $0.30-$0.52 rebate, and transactions for the accounts of
firms and broker-dealers that add liquidity in Non-Penny options are
provided a $0.30-$0.82 rebate; see https://www.cboe.com/us/options/membership/fee_schedule/bzx/. Lastly, per the NYSE Arca Options
trading fee schedule on its public website, transactions for the
accounts of market makers that add liquidity in Non-Penny options
are provided a $0.05-0.40 rebate and transactions for the accounts
of professional customers that add liquidity in Non-Penny options
are provided a $0.75 rebate; see https://www.nyse.com/publicdocs/nyse/markets/arca-options/NYSE_Arca_Options_Fee_Schedule.pdf.
---------------------------------------------------------------------------

    The Exchange believes that it is appropriate, reasonable, and
consistent with the Act to charge fees of $0.60 for routing in Penny
options and $1.20 for routing in Non-Penny options, because these
routing fees are comparable to those charged by other exchanges for
routing Penny and Non-Penny options to away exchanges.\23\
Additionally, the

Exchange believes these fees are equitable and not unfairly
discriminatory because these fees will apply equally to all Options
Members.
---------------------------------------------------------------------------

    \23\ For example, per the NYSE Arca Options trading fee schedule
on its public website, the fee for routing in Penny options is $0.61
and the fee for routing in Non-Penny options is $1.21; see https://www.nyse.com/publicdocs/nyse/markets/arca-options/NYSE_Arca_Options_Fee_Schedule.pdf.
---------------------------------------------------------------------------

    Lastly, the Exchange believes that it is reasonable to add a
definitions section to clarify the terms used in the Options Fee
Schedule, because it will clearly set forth the terms used in the
Transaction Fees portion of the Options Fee Schedule. The Exchange
further believes the definition section is reasonable as other national
securities exchanges include a definition section in their fee
schedule.\24\ The Exchange believes this section is equitable and not
unfairly discriminatory because the definitions section (as part of the
Options Fee Schedule) will be distributed to all Members so that all
Members will have equal clarity on fees charged and rebates provided.
---------------------------------------------------------------------------

    \24\ See supra note 11.
---------------------------------------------------------------------------

    For the reasons discussed above, the Exchange submits that its
proposed fee structure and changes to the Options Transaction Fee
Schedule satisfies the requirements of Sections 6(b)(4) and 6(b)(5) of
the Act \25\ in that it provides for the equitable allocation of
reasonable dues, fees and other charges among its Members and other
persons using its facilities and is not designed to unfairly
discriminate between customers, issuers, brokers, or dealers. As
described more fully below in the Exchange's statement regarding the
burden on competition, the Exchange believes that its transaction
pricing is subject to significant competitive forces, and that the
proposed fees and rebates described herein are appropriate to address
such forces.
---------------------------------------------------------------------------

    \25\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposal will result in any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. As a new entrant in the already
highly competitive environment for options trading, 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. MEMX Options
proposes transaction fees, rebates, and routing fees that are
comparable to transaction fees, rebates and routing fees assessed by
other options exchanges. As a result, the Exchange believes that the
proposal furthers 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.'' \26\
---------------------------------------------------------------------------

    \26\ See supra note 14.
---------------------------------------------------------------------------

Intramarket Competition
    The Exchange does not believe that the proposed rule change will
impose any burden on intramarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act because the
proposed fees and rebates apply equally to all Options Members. The
proposed pricing structure is intended to encourage participants to
trade on MEMX Options by providing rebates that are comparable to those
offered by other exchanges as well as providing competitive fees. The
Exchange believes that the proposed rebates and fees will help to
encourage Options Members to send orders to the Exchange to the benefit
of all Exchange participants. As the proposed fees and rebates are
equally applicable to all market participants, the Exchange does not
believe there is any burden on intramarket competition.
Intermarket Competition
    The Exchange does not believe that the proposed rule change will
impose any burden on intermarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act. To the contrary,
the Exchange believes that the proposed pricing structure will increase
competition and is intended to draw volume to the Exchange as it
commences operations. The Exchange believes that the ever-shifting
market share among the exchanges from month to month demonstrates that
market participants can shift order flow or discontinue to reduce use
of certain categories of products, in response to new or different
pricing structures being introduced into the market. Accordingly,
competitive forces constrain the Exchange's transaction fees and
rebates, and market participants can readily trade on competing venues
if they deem pricing levels at those other venues to be more favorable.
Currently, no single registered options exchange has more than
approximately 18% of the total market share of executed volume of
listed options trading.\27\ As a new exchange, the Exchange expects to
face intense competition from existing exchanges. The proposed pricing
structure is intended to encourage market participants to trade on the
exchange by providing rebates and assessing fees that are comparable to
those offered by other exchanges, which the Exchange believes will help
to encourage Members to send orders to the Exchange to the benefit of
all Exchange participants. As the proposed rates are equally applicable
to all market participants, the Exchange does not believe there is any
burden on intramarket competition.
---------------------------------------------------------------------------

    \27\ Market share percentage calculated as of September 14,
2023. The Exchange receives and processes data made available
through the consolidated data feeds (i.e., OPRA).
---------------------------------------------------------------------------

    Additionally, 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.'' \28\ The fact
that this market is competitive has also long been recognized by the
courts. In NetCoalition v. SEC, 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'. . . .''.\29\ Accordingly, the Exchange does not believe its
proposed pricing changes impose any burden on competition that is not
necessary or appropriate in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \28\ See supra note 14.
    \29\ 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-NYSE-2006-21)).
---------------------------------------------------------------------------

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)(ii) of the Act \30\ and Rule 19b-4(f)(2) \31\ thereunder.
---------------------------------------------------------------------------

    \30\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \31\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    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 shall institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

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 (https://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
file number SR-MEMX-2023-24 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-MEMX-2023-24. 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 (https://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
a.m. and 3 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-MEMX-2023-24 and should be
submitted on or before October 23, 2023.
---------------------------------------------------------------------------

    \32\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\32\
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-21625 Filed 9-29-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: May 18, 2010 (Volume 75, Number 95)]
[Rules and Regulations]
[Page 27647-27649]
[DOCID:fr18my10-8]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2010-0147; FRL-9151-5]

Approval and Promulgation of Air Quality Implementation Plans;
Texas; Revisions to the Emission Credit Banking and Trading Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: EPA is approving severable portions of two revisions to the
Texas State Implementation Plan (SIP) submitted by the State of Texas
on October 24, 2006, and August 16, 2007. These revisions amend
existing sections and create a new section in Title 30 of the Texas
Administrative Code (TAC), Chapter 101--General Air Quality Rules,
Subchapter H--Emissions Banking and Trading, Division 1--Emission
Credit Banking and Trading, referred to elsewhere in this notice as the
Emission Reduction Credit (ERC) Program. The October 24, 2006,
submittal creates a new section for international emission reduction
provisions and amends existing sections to further clarify procedures
for using emission protocols and to update the approved list of
emission credit uses. The August 16, 2007, submittal amends two
sections of the ERC program to update cross-references to recently
recodified 30 TAC Chapter 117 provisions. EPA has determined that these
SIP revisions comply with the Clean Air Act and EPA regulations, are
consistent with EPA policies, and will improve air quality. This action
is being taken under section 110 and parts C and D of the Federal Clean
Air Act (the Act or CAA).

DATES: This final rule will be effective June 17, 2010.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R06-OAR-2010-0147. All documents in the docket are listed in
the http://www.regulations.gov index. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available either
electronically in http://www.regulations.gov or in hard copy at the Air
Planning Section (6PD-L), Environmental Protection Agency, 1445 Ross
Avenue, Suite 700, Dallas, Texas 75202-2733. The file will be made
available by appointment for public inspection in the Region 6 FOIA
Review Room between the hours of 8:30 a.m. and 4:30 p.m. weekdays
except for legal holidays. Contact the person listed in the FOR FURTHER
INFORMATION CONTACT paragraph below or Mr. Bill Deese at<PHONE_NUMBER>
to make an appointment. If possible, please make the appointment at
least two working days in advance of your visit. There will be a 15
cent per page fee for making photocopies of documents. On the day of
the visit, please check in at the EPA Region 6 reception area at 1445
Ross Avenue, Suite 700, Dallas, Texas.
    The State submittal related to this SIP revision, and which is part
of the EPA docket, is also available for public inspection at the State
Air Agency listed below during official business hours by appointment:
    Texas Commission on Environmental Quality, Office of Air Quality,
12124 Park 35 Circle, Austin, Texas 78753.

FOR FURTHER INFORMATION CONTACT: If you have questions concerning
today's final rule, please contact Ms. Adina Wiley (6PD-R), Air Permits
Section, Environmental Protection Agency, Region 6, 1445 Ross Avenue
(6PD-R), Suite 1200, Dallas, TX 75202-2733. The telephone number is
(214) 665-2115. Ms. Wiley can also be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, whenever ``we'',
``us'', or ``our'' is used, we mean the EPA.

Table of Contents

I. What final action is EPA taking?
II. What is the background for this action?
III. What are EPA's responses to comments received on the proposed
action?
IV. Statutory and Executive Order Reviews

I. What final action is EPA taking?

    We are fully approving severable portions of two revisions to the
Texas SIP submitted by the Texas Commission on Environmental Quality
(TCEQ) on

October 24, 2006, and August 16, 2007, specific to the ERC Program. The
revisions we are approving amend existing sections and create a new
section in the ERC Program at Title 30 of the Texas Administrative Code
(TAC), Chapter 101--General Air Quality Rules, Subchapter H--Emissions
Banking and Trading, Division 1--Emission Credit Banking and Trading.
The October 24, 2006, submittal creates a new section for international
emission reduction provisions and amends existing sections to further
clarify procedures for using emission protocols and to update the
approved list of emission credit uses. The severable portions of the
August 16, 2007 submittal that we are approving non-substantively
revise the ERC Program to correctly update the cross-references to the
stationary source nitrogen oxide (NOX) rules found in the
Texas SIP at 30 TAC Chapter 117 as a result of the non-substantive
recodification of Chapter 117 approved by EPA as part of the Texas SIP
on December 3, 2008 (see 73 FR 73562). Consequently, we are approving
the revisions to the Texas SIP at 30 TAC sections 101.302(a),
101.302(d)(1)(C)(vi), 101.302(f), and 101.306(a)(5) and the creation of
new section 101.305 submitted on October 24, 2006. Additionally, we are
approving revisions to the Texas SIP at 30 TAC sections
101.302(d)(1)(A) and 101.306(b)(3) submitted on August 16, 2007, by the
TCEQ.
    EPA proposed the above action on March 30, 2010, at 75 FR 15645-
15648. Today, we are approving the ERC program revisions as proposed
and find that they comply with the CAA and EPA regulations, are
consistent with EPA policies, and will improve air quality. This final
approval is being taken under parts C and D of the CAA.
    In a separate rulemaking, EPA is approving the severable Discrete
Emission Credit Banking and Trading Program (referred to elsewhere in
this notice as the Discrete Emission Reduction Credit (DERC) Program)
revisions at 30 TAC sections 101.372, 101.373, 101.375, 101.376, and
101.378 submitted on October 24, 2006, and 30 TAC sections 101.372 and
101.376 submitted on August 16, 2007 (see EPA-R06-OAR-2010-0418).
    At this time, EPA is not taking action on the revisions to the
Emissions Banking and Trading of Allowances Program at 30 TAC sections
101.338 and 101.339 submitted on October 24, 2006. EPA is also not
taking action at this time on the revisions to the general air quality
definitions at 30 TAC Section 101.1 or the revisions to the System Cap
Trading Program at 30 TAC sections 101.383, and 101.385 submitted on
August 16, 2007. These severable revisions remain under review by EPA
and will be addressed in separate actions.

II. What is the background for this action?

    The ERC Program, SIP-approved by EPA on September 6, 2006,
establishes a market-based trading program for the generation and use
of emission credits (generated and used at a specified emission rate,
tons per year) to provide flexibility for sources in complying with
certain State and Federal requirements. Generally, emission reductions
of criteria pollutants (excluding lead) or precursors of criteria
pollutants for which an area is designated may be banked and used as
emission credits. EPA's September 6, 2006, final approval of the ERC
program addressed the original submission of the program on December
23, 1997, and the subsequent revisions on January 18, 2001; April 14,
2002; January 17, 2003; and December 6, 2004.
    Since our September 6, 2006, final approval, TCEQ has revised the
ERC program to address the commitments of the DERC conditional
approval. Additionally, the TCEQ adopted revisions to the ERC program
consistent with the requirements of Senate Bill 784, adopted during
regular session, 2005, of the 79th Texas Legislature. Senate Bill 784
allows for greater flexibility in the generation and use of
international emission reductions. These revisions were adopted by the
TCEQ on October 4, 2006, and became effective on October 26, 2006. The
adopted regulations were submitted to EPA as a SIP revision on October
24, 2006. TCEQ has also promulgated revisions to the ERC program that
update the cross-references to the new numbering structure in 30 TAC
Chapter 117. These revisions were adopted on July 25, 2007, and became
effective on August 16, 2007. The adopted regulations were submitted to
EPA as a SIP revision on August 16, 2007.

III. What are EPA's responses to comments received on the proposed
action?

    EPA received no comments on our proposed rulemaking.

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act 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 Clean Air Act.
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 Order
12866 (58 FR 51735, October 4, 1993);
     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 Clean Air Act; 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, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must

submit a rule report, which includes a copy of the rule, to each House
of the Congress and to the Comptroller General of the United States.
EPA will submit a report containing this action 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
the rule in the Federal Register. A major rule cannot take effect until
60 days after it is published in the Federal Register. This action is
not a ``major rule'' as defined by 5 U.S.C. 804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by July 19, 2010. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental Relations, Nitrogen oxides, Ozone,
Volatile organic compounds.

    Dated: April 30, 2010.
Lawrence E. Starfield,
Acting Regional Administrator, Region 6.

0
40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart SS--Texas

0
2. The table in Sec.  52.2270(c) entitled ``EPA Approved Regulations in
the Texas SIP'' under Chapter 101 is amended by:
0
a. Revising the entries for Sections 101.302 and 101.306 under
Subchapter H--Emissions Banking and Trading, Division 1--Emission
Credit Banking and Trading.
0
b. Adding an entry for Section 101.305 under Subchapter H--Emissions
Banking and Trading, Division 1--Emission Credit Banking and Trading,
in numerical order.
    The revisions and additions read as follows:

Sec.  52.2270  Identification of plan.

* * * * *
    (c) * * *

                                    EPA-Approved Regulations in the Texas SIP
----------------------------------------------------------------------------------------------------------------
                                                           State
         State citation             Title/subject        approval/      EPA approval date        Explanation
                                                      submittal date
----------------------------------------------------------------------------------------------------------------
                                     Chapter 101--General Air Quality Rules
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                   Subchapter H--Emissions Banking and Trading
                                 Division 1--Emission Credit Banking and Trading
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 101.302................  General Provisions.       7/25/2007  5/18/10 [Insert FR
                                                                       page number where
                                                                       document begins].

                                                  * * * * * * *
Section 101.305................  Emission Reductions       10/4/2006  5/18/10 [Insert FR
                                  Achieved Outside                     page number where
                                  the United States.                   document begins].
Section 101.306................  Emission Credit Use       7/25/2007  5/18/10 [Insert FR
                                                                       page number where
                                                                       document begins].

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

[FR Doc. 2010-11683 Filed 5-17-10; 8:45 am]
BILLING CODE 6560-50-P


"Johansson, Robert"<EMAIL_ADDRESS> 06/08/2007 02:58 PM

To

Lydia Wegman/RTP/USEPA/US@EPA, "Schwab, Margo" <EMAIL_ADDRESS>"Frey, Patrick J." <EMAIL_ADDRESS> cc

Subject

passbacks

Hi Lydia,

Here are the current passbacks on the first 100 pages from us and DOE.

PS Also, I have included general DOE comments in a separate document.

I’ll give you a ring in a minute,

Cheers,

Rob

________________________________________________

Robert Johansson, Ph.D.

OMB/OIRA/NREA

725 17th St. NW, Room 10202

Washington, DC 20503

(P)<PHONE_NUMBER>

(F)<PHONE_NUMBER>

(E<EMAIL_ADDRESS>


   1. Standard Interpretations

   2. Requirements of the HCS and the employer's ability to rely on a manufacturer's hazard determination.
   # --------------------------------------------------------------------------------
Standard Number:
--------------------------------------------------------------------------------
1910.132(d)(1)
--------------------------------------------------------------------------------
1910.1200(g)(5)
--------------------------------------------------------------------------------
1910.1200(h)
OSHA requirements are set by statute, standards and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at http://www.osha.gov.

This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any situation not delineated within the original correspondence.

December 22, 2008

Mr. Michael Fox
9121 E. Tanque Verde Road; #105
Tucson, Arizona 85749

Dear Mr. Fox:

This is in response to your correspondence dated April 22, 2008 to the Occupational Safety and Health Administration (OSHA). Your letter was forwarded to OSHA's Directorate of Enforcement Programs for response. You are requesting clarification of OSHA's Hazard Communication Standard (HCS), 29 CFR 1910.1200. You specifically ask about the requirements of the HCS as they relate to an employer's ability to rely on a manufacturer's hazard determination and the subsequent reporting of those hazards on the material safety data sheet (MSDS). Your scenario and related question are paraphrased below, followed by OSHA's response.

Scenario: An employer is using a chemical product in its facility, and a material safety data sheet for that product is present. The employer performed air monitoring and the results revealed that use of the product generated a "toxic gas." The physical and health hazards associated with employee exposure to the toxic gas are not included on the MSDS.

Question: If an employer is using a product and discovers a health hazard during its use that is not discussed on the MSDS, can that employer ignore the existence of the unreported health hazard and proceed based solely on the hazard information presented on the MSDS (provided by the manufacturer of the product)?

Response: The HCS requires a chemical manufacturer/importer or employer to conduct a hazard determination for each hazardous chemical they produce or import. The results of the hazard determination are then reported by the manufacturer on an MSDS for that product. The manufacturer must develop an MSDS that reflects all of the physical and health hazards associated with the chemical which may occur under normal conditions of use as well as those hazards that may exist during foreseeable emergencies. Under OSHA's HCS, an employer using the chemical (if that employer is different from the manufacturer who performed the hazard determination) is not responsible for making corrections to a deficient or inadequate MSDS.

A manufacturer is only obligated to report on an MSDS those hazards associated with its chemical under normal conditions and those that may occur during a foreseeable emergency. If the product is being used in a manner not intended by the manufacturer, then the manufacturer would not be expected to have any knowledge about this "toxic gas" and would, therefore, not be required under the HCS to include such information on the MSDS.

The HCS allows a downstream employer to rely on the results of the hazard determination performed by the manufacturer or importer which are reported on the MSDS for that chemical (or chemical product). In your scenario, an employer who uses a chemical performs air monitoring and discovers that his employees are exposed to a "toxic gas" whose hazards are not reported on the MSDS. Under these circumstances, the downstream employer may not ignore the newly discovered exposure hazards associated with use of the chemical product.

An employer may contact the product manufacturer directly to notify them of the possibility of the presence of hazards associated with the use of their chemical that are not accurately reflected on the MSDS. A chemical manufacturer that becomes newly aware of significant information regarding the hazards of a chemical has a duty to update its MSDS (29 CFR 1910.1200(g)(5)). Additionally, OSHA has policies and procedures for the field staff to address MSDSs that are deemed to be deficient. For example, an employer may contact the closest OSHA enforcement office and bring the alleged deficiency to their attention. OSHA Instruction 02-00-038, "Inspection Procedures for the Hazard Communication Standard" outlines the procedures to be used by an OSHA office when they are made aware of an MSDS that is believed to be deficient.

Additionally, if an employer has sufficient information about a potential health hazard for which no information is provided on the MSDS, it must provide employees with additional information and training regarding those new hazards. Based on the performance oriented nature of the HCS, if employers have this information, they must provide it to their employees, including information related to how employees can recognize exposures and measures to protect themselves against the workplace hazards. 29 CFR 1910.1200(h).

Lastly, OSHA's standard for General Requirements for Personal Protective Equipment (PPE), 29 CFR 1910.132(d)(1), requires employers to, ". . .assess the workplace to determine if hazards are present, or are likely to be present, which necessitate the use of personal protective equipment (PPE). . ." If the employer's hazard determination results in findings that PPE would protect employees from hazards present in the workplace, then this equipment must be provided by the employer.

As you may be aware, the Arizona Division of Occupational Safety and Health (ADOSH) administers an OSHA-approved state occupational safety and health program for both private and public sector employers and employees in Arizona. State plans are required to implement regulations that are "at least as effective" as the federal standards. For specific Arizona OSHA requirements, we recommend that you contact the Arizona Division of Occupational Safety and Health:

Arizona Division of Occupational Safety and Health
2675 E. Broadway Blvd. #239
Tucson, AZ 85716
Phone:<PHONE_NUMBER>

Thank you for your interest in occupational safety and health. We hope you find this information helpful. OSHA requirements are set by statute, standards, and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult the website.

Sincerely,

Richard E. Fairfax, Director
Directorate of Enforcement Programs


	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

	WASHINGTON, D.C.  20460

OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES

	July 25, 2006

MEMORANDUM

SUBJECT:	Review of Mefluidide Incident Reports

		DP Barcode D324824, Chemical #114001,114002,114003

FROM:	Monica S. Hawkins, M.P.H., Environmental Health Scientist

		Chemistry and Exposure Branch

		Health Effects Division (7509P)

		Hans Allender, Ph.D., Statistician

		Chemistry and Exposure Branch

		Health Effects Division (7509P)

THRU:	David J. Miller, Chief

		Chemistry and Exposure Branch

		Health Effects Division (7509P)

TO:		Pramod Terse, Toxicologist

		Reregistration Branch 4

		Health Effects Division (7509P)

BACKGROUND

	The following data bases have been consulted for the poisoning incident
data on the active ingredient Mefluidide (114001,114002,114003):

1)  OPP Incident Data System (IDS) - reports of incidents from various
sources, including registrants, other federal and state health and
environmental agencies and individual consumers, submitted to OPP since
1992.  Reports submitted to the Incident Data System represent anecdotal
reports or allegations only, unless otherwise stated.  Typically no
conclusions can be drawn implicating the pesticide as a cause of any of
the reported health effects.  Nevertheless, sometimes with enough cases
and/or documentation risk mitigation measures may be suggested.

2)  Poison Control Centers - as the result of a data purchase by EPA,
OPP received Poison Control Center data covering the years 1993 through
2003 for all pesticides.  Most of the national Poison Control Centers
(PCCs) participate in a national data collection system, the Toxic
Exposure Surveillance System which obtains data from about 65-70 centers
at hospitals and universities.  PCCs provide telephone consultation for
individuals and health care providers on suspected poisonings, involving
drugs, household products, pesticides, etc.

3)  California Department of Pesticide Regulation  - California has
collected uniform data on suspected pesticide poisonings since 1982.
Physicians are required, by statute, to report to their local health
officer all occurrences of illness suspected of being related to
exposure to pesticides.  The majority of the incidents involve workers.
Information on exposure (worker activity), type of illness (systemic,
eye, skin, eye/skin and respiratory), likelihood of a causal
relationship, and number of days off work and in the hospital are
provided.

4)  National Pesticide Information Center (NPIC) - NPIC is a toll-free
information service supported by OPP.  A ranking of the top 200 active
ingredients for which telephone calls were received during calendar
years 1984-1991, inclusive has been prepared.  The total number of calls
was tabulated for the categories human incidents, animal incidents,
calls for information, and others.

5) National Institute of Occupational Safety and Health’s Sentinel
Event Notification System for Occupational Risks (NIOSH SENSOR) performs
standardized surveillance in nine states from 1998 through 2003.  States
included in this reporting system are Arizona, California, Florida,
Louisiana, Michigan, New York, Oregon, Texas, and Washington.  Reporting
is very uneven from state to state because of the varying cooperation
from different sources of reporting (e.g., workers compensation, Poison
Control Centers, emergency departments and hospitals, enforcement
investigations, private physicians, etc.).  Therefore, these reports
should not be characterized as estimating the total magnitude of
poisoning.  The focus is on occupationally-related cases not residential
or other non-occupational exposures.   However, the information
collected on each case is standardized and categorized according to the
certainty of the information collected and the severity of the case.

MEFLUIDIDE REVIEW

I. Incident Data System

	There were no reports for mefluidide in the Incident Data System.

II. Poison Control Center Data - 1993 through 2003

	There were no reports located in the Poison Control Center records from
1993 through 2003 involving mefluidide.

III. California Data - 1982 through 2003

	Detailed descriptions of 1 case was submitted to the California
Pesticide Illness Surveillance Program (1982-2003) were reviewed.  In
the case, a worker reported a rash on the side of their face after
several workers passed a vehicle that sprayed the product.

IV. National Pesticide Information Center

	On the list of the top 200 chemicals for which NPIC received calls from
1984-1991 inclusively, mefluidide was not reported to be involved in
human incidents.

V.  NIOSH SENSOR

	Out of 5,899 reported cases from 1998-2003, none involved mefluidide.

VI.  Scientific Literature

	No scientific literature was found concerning human poisoning or other
adverse effects from exposure to mefluidide.

VII. Conclusion

	There was only one report of an ill effect from exposure to mefluidide
in the available data bases.

VIII.  Recommendations

	No recommendations are made based on the limited information available.

cc:	Mefluidide file (114001,114002,114003)

	David J. Miller (7509P)

	Mark Howard (7508P)

ഄ̍഍ഄ഍഍഍഍഍഍഍഍

഍

഍഍഍

഍


[Federal Register Volume 77, Number 64 (Tuesday, April 3, 2012)]
[Proposed Rules]
[Pages 19953-19954]
[FR Doc No: 2012-7941]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 77, No. 64 / Tuesday, April 3, 2012 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2012-0139; Airspace Docket No. 12-ANM-3]

Proposed Amendment of Class E Airspace; Livingston, MT

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to amend Class E airspace at Livingston,
Mission Field Airport, Livingston, MT. Decommissioning of the
Livingston Tactical Air Navigation System (TACAN) has made this action
necessary for the safety and management of Instrument Flight Rules
(IFR) operations at the airport.

DATES: Comments must be received on or before May 18, 2012.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590;
telephone<PHONE_NUMBER>. You must identify FAA Docket No. FAA-2012-
0139; Airspace Docket No. 12-ANM-3, at the beginning of your comments.
You may also submit comments through the Internet at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Eldon Taylor, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA 2012-0139 and Airspace Docket No. 12-ANM-3) and be submitted in
triplicate to the Docket Management System (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to FAA
Docket No. FAA-2012-0139 and Airspace Docket No. 12-ANM-3''. The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified closing date
for comments will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the closing date
for comments. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9 a.m. and 5 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Northwest Mountain Regional Office of the Federal
Aviation Administration, Air Traffic Organization, Western Service
Center, Operations Support Group, 1601 Lind Avenue SW., Renton, WA
98057.
    Persons interested in being placed on a mailing list for future
NPRMs should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
for a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) Part 71 by amending Class E surface airspace at
Livingston, Mission Field Airport, Livingston, MT. Airspace
reconfiguration is necessary due to the decommissioning of the
Livingston TACAN. This action would enhance the safety and management
of aircraft operations at Livingston, Mission Field Airport,
Livingston, MT.
    Class E airspace designations are published in paragraph 6002, of
FAA Order 7400.9V, dated August 9, 2011, and effective September 15,
2011, which is incorporated by reference in 14 CFR Part 71.1. The Class
E airspace designation listed in this document will be published
subsequently in this Order.
    The FAA has determined this proposed regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this proposed regulation; (1) is not a ``significant
regulatory action'' under Executive Order 12866; (2) is not a
``significant rule'' under DOT Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3) does not warrant preparation of a
regulatory evaluation as the anticipated impact is so minimal. Since
this is a routine matter that will only affect air traffic procedures
and air navigation, it is certified this proposed rule, when
promulgated, would not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes
the authority for the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is

promulgated under the authority described in Subtitle VII, Part A,
Subpart I, Section 40103. Under that section, the FAA is charged with
prescribing regulations to assign the use of the airspace necessary to
ensure the safety of aircraft and the efficient use of airspace. This
regulation is within the scope of that authority as it would modify
controlled airspace at Livingston, Mission Field Airport, Livingston,
MT.
    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1E, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR Part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

    1. The authority citation for 14 CFR Part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR Part 71.1 of the
Federal Aviation Administration Order 7400.9V, Airspace Designations
and Reporting Points, dated August 9, 2011, and effective September 15,
2011 is amended as follows:

Paragraph 6002 Class E airspace designated as surface areas.

* * * * *

ANM MT E2 Livingston, MT [Modified]

Livingston, Mission Field, MT
    (Lat. 45[deg]42'09'' N., long. 110[deg]26'50'' W.)

    Within a 4.1-mile radius of the Mission Field Airport, and
within 2.7 miles each side of the Mission Field Airport 340[deg]
bearing extending from the 4.1-mile radius to 7 miles north of the
airport. This Class E airspace area is effective during the specific
dates and times established in advance by a Notice to Airmen. The
effective date and time will thereafter be continuously published in
the Airport/Facility Directory.

    Issued in Seattle, Washington, on March 26, 2012.
Robert Henry,
Acting Manager, Operations Support Group, Western Service Center.
[FR Doc. 2012-7941 Filed 4-2-12; 8:45 am]
BILLING CODE 4910-13-P


Table A Respondent Reporting and Recordkeeping New Residential Wood Heaters  NSPS Subpart AAA Regulatory Reference Regulated Reporting/ Recordkeeping Frequency/ Other Title 40, Part 60 Enity Requirement Comments 60.533( f)( l) Manufacturer Report: Notification of Once per model.

certification testing at least 30 days prior to test.

60.533( b) Manufacturer Report: Application for Once for each model line for certification. Includes each phase of the standard identifying charaterization ( unless wood heater qualifies data, complete certification for Phase II standard). Must test results, and various reapply every 5 years.

affirmations of compliance.

60.537( f) Manufacturer Report: To EPA certifying Every 2 years.

that model line is unchanged.

60.536( a) Manufacturer Report: Produce and apply One per unit produced.

permanent label.

60.536( i) Manufacturer Produce and apply removable One per unit produced.

label.

60.536( l) Manufacturer Develop and publish owners One per unit produced.

manual. 2 Table A, Continued Respondent Reporting and Recordkeeping New Residential Wood Heaters  NSPS Subpart AAA Regulatory Reference Regulated Reporting/ Recordkeeping Frequency/ Other Title 40, Part 60 Enity Requirement Comments 60.533( o)( 3) Manufacturer Report: Notify EPA that a Once for each Q. A. emission Q. A. emissions test will be test.

conducted w/ in one week of the mailing of the notice.

Submit test report for accelerated Q. A.

[( o)( 3)( iii)]*

60.537( a)( 2) Manufacturer Maintain records of all Once per model.

certification data.

60.533( o) Manufacturer Recordkeeping of results, Parameter inspections every & remedial measures taken 150 units. Emission tests vary 60.537( a)( 3), pursuant to quality according to manufacturer size ( a)( 4) assurance program. and certification results.

60.537( a)( 5) Manufacturer Maintain records of the Continuously through number of wood heaters sold production year.

each year.

60.537( g) Manufacturer Recordkeeping for all models Variable unpredictable.

and units exempted under R and D provision.

60.537( c) Manufacturer Retain sealed wood heater One for each certified model.

for the life of the model. 3 Table A, Continued Respondent Reporting and Recordkeeping New Residential Wood Heaters  NSPS Subpart AAA Regulatory Reference Regulated Reporting/ Recordkeeping Frequency/ Other Title 40, Part 60 Enity Requirement Comments 60.533( i)* Manufacturer Report: Request for waiver Once per model, if at all.

of testing requirement for certification testing.

60.533( h)( 3)** Manufacturer Report: Application for Once per model, if at all.

alternative certification.

60.533( k)( l) Manufacturer Report: Request for waiver Variable.

of the requirement that a model line be recertified when changes exceed specified tolerances.

60.533( p)( 5)** Manufacturer Development of documentation Variable, but no more than one to rebut presumption of for every four certified audit failure. models.

60.535( a)( 1) Laboratory Report: Application for One per lab.

accreditation.

60.535( b)( 5) Laboratory Report: Proficiency test At time of application and and all test documentation. annually.

60.535( b)( 3) Laboratory Keep records of audit tests. Once for each five certification tests.

Table A, Continued Respondent Reporting and Recordkeeping New Residential Wood Heaters  NSPS Subpart AAA 4 Regulatory Reference Regulated Reporting/ Recordkeeping Frequency/ Other Title 40, Part 60 Enity Requirement Comments 60.534( e)( 1)( 3) Laboratory Report: To EPA changes in Once per test.

testing schedule or interruptions in testing.

60.537( b)( 1) Laboratory Maintain records of Once per certified model.

certification test data.

60.535( g) Laboratory Recordkeeping. Seal each Once per model certified.

certified woodheater.

60.533( h)( 4)** Laboratory Report: Submission of Once per model, if at all.

preliminary test reports from laboratory to EPA and manufacturer for wood heaters which exceed emission limits.

Report is submitted within 10 days of test completion.

( This provision for wood heaters which have been granted alternative certification, only.) 5 Table A, Continued Respondent Reporting and Recordkeeping New Residential Wood Heaters  NSPS Subpart AAA 60.537( h) Commercial Name and address of previous Variable.

Owner ( e. g., owner of a used stove that he retailer) has purchased or obtained as a trade in.

* This is associated with an exemption or waiver ( which would eliminate other reporting and recordkeeping burdens) and, therefore, is not counted as a burden in the calculation.

** This is not a routine report. It is a provision for an extraordinary circumstance and, therefore, is not included in the calculations because it is very unlikely to occur during the next 3 years.