[Federal Register Volume 84, Number 82 (Monday, April 29, 2019)]
[Notices]
[Pages 18018-18019]
[FR Doc No: 2019-08552]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP19-139-000]

Shell Pipeline Company, LP and Enbridge Offshore Facilities, LLC;
Notice of Joint Petition for Declaratory Order

    Take notice that on April 23, 2019, Shell Pipeline Company LP and
Enbridge Offshore Facilities, LLC submitted a petition for a
Declaratory Order (petition) confirming that certain proposed offshore
facilities and operations described in the petition will not be
considered engaged in the transportation of natural gas subject to the
Commission's jurisdiction under the Natural Gas Act (NGA).
    The filing may also be viewed on the web at http://www.ferc.gov
using the ``eLibrary'' link. Enter the docket number excluding the last
three digits in the docket number field to access the document. For
assistance, please contact FERC Online Support at
[email protected] or toll free at<PHONE_NUMBER>, or TTY,
contact<PHONE_NUMBER>.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit five copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone

will not serve to make the filer a party to the proceeding. The
Commission's rules require that persons filing comments in opposition
to the project provide copies of their protests only to the party or
parties directly involved in the protest.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit original and five copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426.
    Comment Date: 5:00 p.m. Eastern Time on May 14, 2019.

    Dated: April 23, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-08552 Filed 4-26-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 115 (Friday, June 14, 2019)]
[Notices]
[Pages 27781-27782]
[FR Doc No: 2019-12564]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-1876]

Testing for Biotin Interference in In Vitro Diagnostic Devices;
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 document entitled ``Testing for Biotin
Interference in In Vitro Diagnostic Devices; Draft Guidance for
Industry.'' The draft guidance document provides FDA's recommendations
on the testing for interference by biotin on the performance of in
vitro diagnostic devices (IVDs). The draft guidance is intended to help
device developers and clinicians understand how FDA recommends biotin
interference testing should be performed and how the results of the
testing should be communicated to end users, including clinical
laboratories and clinicians. FDA also recommends that manufacturers of
currently marketed devices consider these draft recommendations.

DATES: Submit either electronic or written comments on the draft
guidance by August 13, 2019 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-2019-D-1876 for ``Testing for Biotin Interference in In Vitro
Diagnostic Devices; Draft Guidance for Industry.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed

except in accordance with 21 CFR 10.20 and other applicable disclosure
law. For more information about FDA's posting of comments to public
dockets, see 80 FR 56469, September 18, 2015, or access the information
at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    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 draft guidance to
the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002 or the Office of Policy, Guidance and Policy Development, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist the office in
processing your requests. The draft guidance may also be obtained by
mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.

FOR FURTHER INFORMATION CONTACT: Shruti Modi, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled
``Testing for Biotin Interference in In Vitro Diagnostic Devices.'' The
draft guidance document provides FDA's recommendations on the testing
for interference by biotin on the performance of IVDs. The draft
guidance is intended to help device developers and clinicians
understand how FDA recommends that biotin interference testing be
performed and how the results of the testing should be communicated to
end users, including clinical laboratories and clinicians. FDA also
recommends that manufacturers of currently marketed devices consider
these draft recommendations. The recommendations apply to IVDs, as well
as devices that are licensed under section 351 of the Public Health
Service Act (42 U.S.C. 262) and used in donor screening, that use
biotin technology.
    Biotin, also known as vitamin B7, is a water-soluble vitamin often
found in multivitamins, prenatal vitamins, and dietary supplements
marketed for hair, skin, and nail growth. FDA has become aware of
potential biotin interference with IVDs that use biotin/avidin
interactions as part of the device technology. Biotin in patient
samples can cause falsely high or falsely low results, depending on the
test.
    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 testing for
biotin interference in in vitro diagnostic devices. 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. This guidance
is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 809 have been approved under
OMB control number 0901-0485.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, or https://www.regulations.gov.

    Dated: June 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12564 Filed 6-13-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 15 (Thursday, January 23, 2020)]
[Rules and Regulations]
[Pages 3853-3854]
[FR Doc No: 2020-00292]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2019-0910]

Drawbridge Operation Regulation; Bayou Sara, Saraland, AL

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations; request for
comments.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the CSX Transportation Railroad swing
bridge across Bayou Sara, mile 0.1 near Saraland, Alabama. This
deviation is needed to collect and analyze information on vessel
traffic when the bridge tender is moved to a geographically remote
centralized control point located in Mobile, AL. The Coast Guard is
seeking comments from the public about the impact to vessel traffic
generated by this change.

DATES: This deviation is effective from 6 a.m. January 23, 2020 through
6 p.m. March 23, 2020.
    Comments and related material must be received by the Coast Guard
on or before March 23, 2020.

ADDRESSES: You may submit comments identified by docket number USCG-
2019-0910 using Federal eRulemaking Portal at http://www.regulations.gov.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section for further instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email Mr. Doug Blakemore, Eighth Coast
Guard District Bridge Administrator; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background, Purpose and Legal Basis

    CSX Railroad has established a central location to operate CSX
drawbridges. They have requested to relocate the Bayou Sara bridge
tender to their centralized location in Mobile, AL. This CSX swing
bridge is located at Bayou Sara, mile 0.1, Mobile County, near
Saraland, AL. It has a vertical clearance of 5' in the closed to vessel
position. The bridge operates according to 33 CFR 117.105. Bayou Sara
is used primarily by recreational vessels. The bridge opens for vessels
about 6 times per day and vessels that do not need the bridge to open
may pass.
    This deviation will last for 60 days. CSX will collect data on all
bridge openings to ensure that the remote operations will not impact
navigation. CSX will immediately return the tender to the bridge
location if there are any system failures or weather conditions that
will not allow the bridge tender to operate the bridge from Mobile.
    The Coast Guard will publish information about this temporary
deviation in our Local and Broadcast Notice to Mariners so that
mariners are informed of this operating change and our request for
comments on the change.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

II. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, visit http://www.regulations.gov/privacynotice.
    Documents mentioned in this NPRM as being available in this docket
and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that website's
instructions. Additionally, if you go to the online docket and sign up
for email alerts, you will be notified when comments are posted or a
final rule is published.

    Dated: January 7, 2020.
Douglas Allen Blakemore, Sr.,
Bridge Administrator, Eighth Coast Guard District.
[FR Doc. 2020-00292 Filed 1-22-20; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 84, Number 139 (Friday, July 19, 2019)]
[Notices]
[Pages 34960-34963]
[FR Doc No: 2019-15348]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-86375; File No. SR-CboeEDGX-2019-045]

Self-Regulatory Organizations; Cboe EDGX Exchange, Inc.; Notice
of Filing and Immediate Effectiveness of a Proposed Rule Change
Relating To Amend the Exchange's Fee Schedule Applicable to Its
Equities Trading Platform (``EDGX Equities'') To Adopt a ``Retail
Volume Tier'' for Firms That Execute a Significant Volume of Liquidity
Providing Retail Order Flow on EDGX

July 15, 2019.
    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 July 1, 2019, Cboe EDGX Exchange, Inc. (``Exchange'' or ``EDGX'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule

change as described in Items I, II, and III below, which Items have
been prepared by the Exchange. The Commission is publishing this notice
to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Cboe EDGX Exchange, Inc. (``EDGX'' or the ``Exchange'') is filing
with the Securities and Exchange Commission (the ``Commission'') a
proposed rule change to amend the Exchange's fee schedule applicable to
its equities trading platform (``EDGX Equities'') to adopt a ``Retail
Volume Tier'' for firms that execute a significant volume of liquidity
providing retail order flow on EDGX. The text of the proposed changes
to the fee schedule are attached [sic] as Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/options/regulation/rule_filings/edgx/), at the Exchange's Office of the Secretary, and at
the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of the proposed rule change is to amend the EDGX
Equities fee schedule to adopt a ``Retail Volume Tier'' for firms that
execute a significant volume of liquidity providing retail order flow
on EDGX, effective July 1, 2019. The Exchange believes the proposed
change would encourage more liquidity and opportunities for investors
to trade on the Exchange.
    The Exchange first notes that it operates in a highly-competitive
market in which market participants can readily direct order flow to
competing venues if they deem fee levels at a particular venue to be
excessive or incentives to be insufficient. More specifically, the
Exchange is only one of several equity venues to which market
participants may direct their order flow, and it represents a small
percentage of the overall market. The competition for Retail Order flow
is even more intense, particularly as it relates to exchange versus
off-exchange venues. For example, the Exchange examined Rule 606
disclosures from three prominent retail brokerages: E-Trade, TD
Ameritrade and Charles Schwab. For securities listed on the New York
Stock Exchange LLC in the first quarter of 2019, TD Ameritrade routed
80% of its limit orders to off-exchange venues.\3\ Similarly, E-Trade
Financial and Charles Schwab routed more than 77% and more than 90%,\4\
respectively, of its limit orders to off-exchange venues. This
competition is particularly acute for non-marketable Retail Orders,
i.e., Retail Orders that provide liquidity, and even more fiercely for
non-marketable Retail Orders that provide displayed liquidity on an
exchange. Accordingly, competitive forces compel the Exchange to use
exchange transaction fees and credits, particularly as they relate to
competing for Retail Order flow, because market participants can
readily trade on competing venues if they deem pricing levels at those
other venues to be more favorable.
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    \3\ See https://www.tdameritrade.com/retail-en_us/resources/pdf/AMTD2054.pdf.
    \4\ See https://content.etrade.com/etrade/powerpage/pdf/OrderRouting11AC6.pdf. See also https://www.schwab.com/public/schwab/nn/legal_compliance/important_notices/order_routing.html.
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    For example, the Exchange provides special pricing for Retail
Orders \5\ as an incentive for members to bring such orders to EDGX
instead of another exchange or off-exchange venue. Specifically, Retail
Orders priced at or above $1.00 that add liquidity and yield fee code
ZA \6\ currently benefit from an enhanced rebate of $0.00320 per share
(as compared to non-Retail Orders that add liquidity and receive a
standard rebate of $0.00170 per share). The Exchange is interested in
attracting additional retail order flow, and therefore proposes to
introduce a Retail Volume Tier that is designed to encourage even more
retail participation. More specifically, the Retail Volume Tier would
provide a further enhanced rebate to liquidity providing Retail Orders,
provided that the member executes a specified average daily volume
(``ADV'') \7\ in such orders on EDGX. As proposed, a Retail Order that
adds liquidity under fee code ZA would be eligible for a rebate of
$0.0037 per share if the member's ADV in Retail Orders that add
liquidity (i.e., yielding fee code ZA) is greater than or equal to
0.50% of Total Consolidated Volume (``TCV'').\8\
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    \5\ See EDGX Rule 11.21(a)(1). A ``Retail Order'' is an agency
or riskless principal order that meets the criteria of FINRA Rule
5320.03 that originates from a natural person and is submitted to
the Exchange by a Retail Member Organization, provided that no
change is made to the terms of the order with respect to price or
side of market and the order does not originate from a trading
algorithm or any other computerized methodology. See EDGX Rule
11.21(a)(2). Retail Orders are submitted by a Retail Member
Organization'' or ``RMO'', which is a member (or a division thereof)
that has been approved by the Exchange to submit such orders.
    \6\ ``ZA'' is associated with Retail Orders that add liquidity.
    \7\ ADV means average daily volume calculated as the number of
shares added to, removed from, or routed by, the Exchange, or any
combination or subset thereof, per day. ADV is calculated on a
monthly basis. See Cboe EDGX U.S. Equities Exchange Fee Schedule.
    \8\ TCV means total consolidated volume calculated as the volume
reported by all exchanges and trade reporting facilities to a
consolidated transaction reporting plan for the month for which the
fees apply.
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2. Statutory Basis
    The Exchange believes that the proposed rule changes are consistent
with the objectives of Section 6 of the Act,\9\ in general, and
furthers the objectives of Section 6(b)(4),\10\ in particular, as it is
designed to provide for the equitable allocation of reasonable dues,
fees and other charges among its Members and other persons using its
facilities and does not unfairly discriminate between customers,
issuers, brokers or dealers. The Exchange operates in a highly-
competitive market in which market participants can readily direct
order flow to competing venues if they deem fee levels at a particular
venue to be excessive or incentives to be insufficient. The proposed
rule change reflects a competitive pricing structure designed to
incentivize market participants to direct their retail order flow to
the Exchange, which the Exchange believes would enhance market quality
to the benefit of all Members.
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    \9\ 15 U.S.C. 78f.
    \10\ 15 U.S.C. 78f(b)(4).
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    In particular, the Exchange believes the proposed tier is
reasonable because it provides an opportunity for Members to receive an
enhanced rebate for Retail Orders. The Exchange notes that volume-based
incentives and discounts have been widely adopted by exchanges,\11\
including the Exchange,\12\

and are reasonable, equitable and non-discriminatory because they are
open to all members on an equal basis and provide additional benefits
or discounts that are reasonably related to (i) the value to an
exchange's market quality and (ii) associated higher levels of market
activity, such as higher levels of liquidity provision and/or growth
patterns. Additionally, as noted above, the Exchange operates in highly
competitive market. The Exchange is only one of several equity venues
to which market participants may direct their order flow, and it
represents a small percentage of the overall market. Competing equity
exchanges offer similar tiered pricing structures to that of the
Exchange, including schedules of rebates and fees that apply based upon
members achieving certain volume and/or growth thresholds. These
competing pricing schedules, moreover, are presently comparable to
those that the Exchange provides.\13\
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    \11\ See e.g., Cboe BZX U.S. Equities Exchange Fee Schedule,
Footnote 1, Add Volume Tiers.
    \12\ See e.g., Cboe EDGX U.S. Equities Exchange Fee Schedule,
Footnote 1, Add Volume Tiers.
    \13\ See e.g., NYSE Arca Equities, Fees and Charges, Basic
Rates, which assesses a standard credit of $0.0030 per share for
Retail Orders that add liquidity.
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    The Exchange currently provides pricing incentives to Retail Member
Organizations that execute liquidity providing Retail Orders on EDGX,
and desires to further enhance those incentives in order to encourage
additional retail participation. The proposed Retail Volume Tier would
achieve that result by providing a higher rebate to Retail Orders that
provide liquidity if submitted by a member that executes a significant
volume of liquidity providing Retail Orders on EDGX. The Exchange notes
that NYSE Arca, Inc. (``Arca'') also operates a similar volume-based
rebate program that provides tiered rebates of up to $0.0035 per share
to attract retail order flow.\14\
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    \14\ See Arca Equities Fees and Charges, Trade Related Fees and
Credits, Retail Order Tier and Retail Order Step-Up Tiers. Members
receive an enhanced credit of $0.0033 per share for Retail orders
that provide liquidity to the books where a Member meets the
criteria set forth in Retail Order Tier and Retail Order Step-Up
Tier 1. Members receive an enhanced credit of $0.0035 per share for
Retail Orders that provide liquidity under Retail Order Step-Up Tier
2 where a Member meets the criteria set forth under the Tier.
Specifically, the Member must (1) submit an average daily share
volume per month of resting limit orders (i.e., provide liquidity)
in an amount equal to or greater than 1.10% or more of US
Consolidated Average Daily Volume (``CADV''), and (2) execute during
the month, Retail Orders with a time-in-force of Day that is an
increase of 0.35% or more of the US CADV from the ETP Holder's April
2018 ADV, taken as a percentage of US CADV.
---------------------------------------------------------------------------

    The Exchange believes that the proposed Retail Volume Tier is
reasonable and equitable as it would allow EDGX to effectively compete
for retail order flow with Arca as well as other exchanges and the many
off-exchange venues that execute the majority of retail order flow
today. The Exchange believes that the current proposal, including the
level of rebate and corresponding threshold, is appropriately designed
to attract Retail Orders to EDGX given the high degree of competition
for such orders in today's market, which was discussed above. The
Exchange believes that attracting liquidity in Retail Orders would
incentivize other members to send order flow to EDGX to trade with such
Retail Orders. In addition, the Exchange believes that this increased
liquidity would potentially stimulate further price competition for
Retail Orders, thereby deepening the Exchange's liquidity pool in both
and retail and other orders, supporting the quality of price discovery,
and promoting market transparency.
    The Exchange also believes that the proposed Retail Volume Tier is
not unfairly discriminatory because it applies equally to all members
that execute liquidity providing Retail Orders and meet the specified
volume threshold. Without having a view of Members' activity on other
markets and off-exchange venues, the Exchange has no way of knowing
whether this proposed rule change would definitely result in any
Members qualifying for this tier. However, the Exchange believes the
proposed tier will provide an incentive for Retail Member Organizations
to increase retail order flow to EDGX. Retail Member Organizations that
do not meet the proposed volume threshold would continue to earn the
current rebate, which already provides a significant incentive for
executing retail order flow on EDGX.
    The Exchange believes that it is appropriate to limit the proposed
enhanced rebate to Retail Orders as the Exchange is attempting to
increase retail participation. Retail participation is more likely to
reflect long-term investment intentions, and may therefore positively
impact market quality. Accordingly, the presence of Retail Orders on
EDGX has the potential to benefit all market participants. As explained
in the purpose section of this proposed rule change, competition for
retail order flow is particularly fierce, as demonstrated by the
percentage of Retail Orders that are executive off-exchange also by
Arca providing a high rebate to market participants that execute a
significant amount of such orders on that exchange. In that context,
the Exchange believes that it is appropriate to provide additional
incentives to Retail Orders in order to attract that order flow.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on intramarket or intermarket competition that is not
necessary or appropriate in furtherance of the purposes of the Act.
Rather, as discussed above, the Exchange believes that the proposed
change would encourage the submission of additional liquidity to a
public exchange, thereby promoting market depth, price discovery and
transparency and enhancing order execution opportunities for all
Members. As a result, the Exchange believes that the proposed change
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.'' \15\
---------------------------------------------------------------------------

    \15\ Securities Exchange Act Release No. 51808, 70 FR 37495,
37498-99 (June 29, 2005) (S7-10-04) (Final Rule).
---------------------------------------------------------------------------

    The Exchange believes the proposed rule change does impose any
burden on intramarket competition that is not necessary or appropriate
in furtherance of the purposes of the Act. Particularly, the proposed
change applies uniformly to market participants. The Exchange believes
that the proposed tier would incentivize market participants to direct
providing Retail Order flow to the Exchange. Greater liquidity benefits
all market participants on the Exchange by providing more trading
opportunities and encourages Members to send orders, thereby
contributing to robust levels of liquidity, which benefits all market
participant. While the proposed tier is only available for Retail
Orders, the Exchange notes it is attempting to increase retail
participation and that, as noted above, retail participation is more
likely to reflect long-term investment intentions, and may therefore
positively impact market quality.
    Next, the Exchange believes the proposed rule change does not
impose any burden on intermarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act. As previously
discussed, the Exchange operates in a highly competitive market.
Members have numerous alternative venues that they may participate on
and direct their order flow, including 12 other equities exchanges and
off-exchange venues, including 32 alternative trading systems.
Additionally, the Exchange represents a

small percentage of the overall market. Based on publicly available
information, no single equities exchange has more than 23% of the
market share.\16\ Therefore, no exchange possesses significant pricing
power in the execution of option order flow. Indeed, participants can
readily choose to send their orders to other exchange and off-exchange
venues if they deem fee levels at those other venues to be more
favorable. Additionally, as discussed above, the market for Retail
Orders in even more stark given the amount of Retail Orders that are
routed to and executed on off-exchange venues. Moreover, the Commission
has repeatedly expressed its preference for competition over regulatory
intervention in determining prices, products, and services in the
securities markets. Specifically, in Regulation NMS, the Commission
highlighted the importance of market forces in determining prices and
SRO revenues and, also, recognized that current regulation of the
market system ``has been remarkably successful in promoting market
competition in its broader forms that are most important to investors
and listed companies.'' \17\ The fact that this market is competitive
has also long been recognized by the courts. In NetCoalition v.
Securities and Exchange Commission, the D.C. Circuit stated as follows:
``[n]o one disputes that competition for order flow is `fierce.' . . .
As the SEC explained, `[i]n the U.S. national market system, buyers and
sellers of securities, and the broker-dealers that act as their order-
routing agents, have a wide range of choices of where to route orders
for execution'; [and] `no exchange can afford to take its market share
percentages for granted' because `no exchange possesses a monopoly,
regulatory or otherwise, in the execution of order flow from broker
dealers'. . . .''.\18\ Accordingly, the Exchange does not believe its
proposed fee change imposes any burden on competition that is not
necessary or appropriate in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \16\ See Cboe Global Markets U.S. Equities Market Volume Summary
(June 28, 2019), available at http://markets.cboe.com/us/equities/market_share/.
    \17\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496, 37499 (June 29, 2005).
    \18\ NetCoalition v. SEC, 615 F.3d 525, 539 (D.C. Cir. 2010)
(quoting Securities Exchange Act Release No. 59039 (December 2,
2008), 73 FR 74770, 74782-83 (December 9, 2008) (SR-NYSEArca-2006-
21)).
---------------------------------------------------------------------------

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \19\ and paragraph (f) of Rule 19b-4 \20\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78s(b)(3)(A).
    \20\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CboeEDGX-2019-045 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-CboeEDGX-2019-045. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-CboeEDGX-2019-045 and should be
submitted on or before August 9, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\21\
---------------------------------------------------------------------------

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

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-15348 Filed 7-18-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: June 29, 2009 (Volume 74, Number 123)]
[Notices]
[Page 31024-31025]
[DOCID:fr29jn09-48]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings No 1

June 15, 2009.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP09-614-000.
    Applicants: Cheniere Creole Trail Pipeline Company.
    Description: Cheniere Creole Trail Pipeline Company Request for
Limited Waiver of EDI/EDM and FF/EDM Requirements and Order No. 712
Electronic Capacity Release Requirements.
    Filed Date: 05/27/2009.
    Accession Number: 20090527-5144.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 17, 2009.

    Docket Numbers: RP09-761-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Petition for Temporary Waiver of Tariff Provisions and
Request for Expedited Action by Natural Gas Pipeline Company of America
LLC.
    Filed Date: 06/09/2009.
    Accession Number: 20090610-0103.
    Comment Date: 5 p.m. Eastern Time on Monday, June 22, 2009.

    Docket Numbers: RP09-762-000.
    Applicants: El Paso Natural Gas Company.
    Description: El Paso Natural Gas Company submits Fourth Revised
Sheet 322 et al to FERC Gas Tariff, Second Revised Volume 1A, to be
effective 8/1/09.
    Filed Date: 06/10/2009.
    Accession Number: 20090610-0101.
    Comment Date: 5 p.m. Eastern Time on Monday, June 22, 2009.

    Docket Numbers: RP09-763-000.
    Applicants: Transcontinental Gas Pipe Line Company.
    Description: Transcontinental Gas Pipeline Company, LLC submits
Second Revised Sheet 21 et al to FERC Gas Tariff, Fourth Revised Volume
1, to be effective 7/12/09 .
    Filed Date: 06/11/2009.
    Accession Number: 20090612-0013.
    Comment Date: 5 p.m. Eastern Time on Tuesday, June 23, 2009.

    Docket Numbers: RP09-764-000.
    Applicants: WTG Hugoton, LP.
    Description: WTG Hugoton, LP submits First revised Sheet 205 et al
of its FERC Gas Tariff, to be effective 8/1/09.
    Filed Date: 06/12/2009.
    Accession Number: 20090615-0031.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 24, 2009.

    Docket Numbers: RP09-765-000.
    Applicants: Viking Gas Transmission Company.
    Description: Viking Gas Transmission Company submits Sixth Revised
Sheet 871 to Original Sheet 871.01 and 871.02 to FERC Gas Tariff, First
Revised Volume 1, to be effective 6/12/09.
    Filed Date: 06/12/2009.
    Accession Number: 20090615-0042.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 24, 2009.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E9-15266 Filed 6-26-09; 8:45 am]

BILLING CODE 6717-01-P


July 15, 2005 MEMORANDUM From: Michael Galbraith, USEPA/ OSW To: Hazardous Waste Combustor MACT Rule Docket, OAR 2004 0022 Subject: Telephone Conversation with Utah DEQ Regarding 2001 Clean Harbor Emission Test On May 12, 2005, I had a telephone conversation with Rick Page, who is a RCRA permitting official for the Utah Department of Environmental Quality. I requested Mr. Page to assist me in addressing a comment we had received on our proposed MACT rule for hazardous waste combustors. The commenter claimed that Clean Harbor's Aragonite facility encountered problems with their carbon injection system during their 2001 emissions test. As a result, the commenter claimed that EPA should not use the dioxin/ furan emissions data from this test to calculate MACT floors.

Mr. Page verified that Clean Harbors communicated to UTAH DEQ that they did in fact encounter problems with the carbon injection during this emissions test. More importantly, Mr. Page indicated that operating parameter limits for the carbon injection system ( e. g., carbon injection rate) were not established as a result of this emission test.


[Federal Register: January 21, 2009 (Volume 74, Number 12)]
[Proposed Rules]
[Page 3468-3469]
[DOCID:fr21ja09-28]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2008-1026; Airspace Docket No. 08-AEA-17]
RIN 2120-AA66

Proposed Establishment of Area Navigation Route Q-42; East-
Central United States

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to establish a high altitude area
navigation (RNAV) route, designated Q-42, extending between the New
York-Philadelphia area and the Kirksville, MO, very high frequency
omnidirectional range/tactical air navigation (VORTAC) aid. The route
would streamline RNAV procedures in the east-central United States by
creating a route parallel to the existing Jet Route J-80. The new route
would help alleviate departure delay issues for westbound aircraft
flying from the New York and Philadelphia areas.

DATES: Comments must be received on or before March 9, 2009.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, M-30, 1200 New Jersey Avenue, SE.,
West Building Ground Floor, Room W12-140, Washington, DC 20590-0001;
telephone:<PHONE_NUMBER>. You must identify FAA Docket No. FAA-2008-
1026 and Airspace Docket No. 08-AEA-17 at the beginning of your
comments. You may also submit comments through the Internet at http://
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Paul Gallant, Airspace and Rules
Group, Office of System Operations Airspace and AIM, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591;
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-2008-1026 and Airspace Docket No. 08-AEA-17) and be submitted in
triplicate to the Docket Management Facility (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-2008-1026 and Airspace Docket No. 08-AEA-17.''
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 NPRM's

    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 ADDRESSES section for 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 office of the Eastern Service Center, Federal Aviation
Administration, Room 210, 1701 Columbia Ave., College Park, GA 30337.
    Persons interested in being placed on a mailing list for future
NPRM's 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 to establish a high altitude RNAV route,
designated Q-42, between the ELIOT, PA, navigation fix and the
Kirksville, MO, VORTAC. The new route would help alleviate departure
delays by providing an additional route, generally parallel to existing
Jet Route J-80, to handle westbound departure traffic from the New York
and Philadelphia airports. The new route would traverse airspace
assigned to the New York, Cleveland, Indianapolis, Chicago and Kansas
City Air Route Traffic Control Centers.
    High altitude RNAV routes are published in paragraph 2006 of FAA
Order 7400.9S signed October 3, 2008 and effective October 31, 2008,
which is incorporated by reference in 14 CFR 71.1. The RNAV route
listed in this document will be published subsequently in the Order.
    The FAA has determined that 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 Department of Transportation (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 that this proposed rule, when promulgated, will 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 United States Code. Subtitle I, Section 106
describes the authority of 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 establishes an RNAV route to enhance the safe and efficient flow
of traffic in the east-central United States.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures,'' paragraph 311a, 311b. This airspace action is not
expected to cause any potentially significant environmental impacts,
and no extraordinary circumstances exist that warrant preparation of an
environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, 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 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 71.1 of FAA Order
7400.9S, Airspace Designations and Reporting Points, signed October 3,
2008 and effective October 31, 2008, is amended as follows:

Paragraph 2006 United States Area Navigation Routes.

* * * * *

                                         Q-42 IRK MO to ELIOT, PA [New]

 IRK........................  VORTAC..............  (Lat. 40[deg]08[min]06[sec] N., long. 92[deg]35[min]30[sec]
                                                     W.)
STRUK.......................  WP..................  (Lat. 40[deg]14[min]04[sec] N., long. 90[deg]18[min]22[sec]
                                                     W.)
DNV.........................  VORTAC..............  (Lat. 40[deg]17[min]38[sec] N., long. 87[deg]33[min]26[sec]
                                                     W.)
MIE.........................  VOR/DME.............  (Lat. 40[deg]14[min]14[sec] N., long. 85[deg]23[min]39[sec]
                                                     W.)
HIDON.......................  WP..................  (Lat. 40[deg]10[min]00[sec] N., long. 81[deg]37[min]27[sec]
                                                     W.)
BUBAA.......................  WP..................  (Lat. 40[deg]10[min]27[sec] N., long. 80[deg]58[min]17[sec]
                                                     W.)
PSYKO.......................  WP..................  (Lat. 40[deg]08[min]37[sec] N., long. 79[deg]09[min]13[sec]
                                                     W.)
BRNAN.......................  WP..................  (Lat. 40[deg]08[min]07[sec] N., long. 77[deg]50[min]07[sec]
                                                     W.)
MAALS.......................  WP..................  (Lat. 40[deg]19[min]16[sec] N., long. 76[deg]16[min]08[sec]
                                                     W.)
SUZIE.......................  WP..................  (Lat. 40[deg]27[min]12[sec] N., long. 75[deg]58[min]22[sec]
                                                     W.)
ETX.........................  VOR/DME.............  (Lat. 40[deg]34[min]52[sec] N., long. 75[deg]41[min]02[sec]
                                                     W.)
ELIOT.......................  WP..................  (Lat. 40[deg]49[min]07[sec] N., long. 75[deg]07[min]48[sec]
                                                     W.)

* * * * *

    Issued in Washington, DC, on January 12, 2009.
Edith V. Parish,
Manager, Airspace & Rules Group.
 [FR Doc. E9-1112 Filed 1-16-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register: September 1, 2010 (Volume 75, Number 169)]
[Rules and Regulations]
[Page 53581-53586]
[DOCID:fr01se10-6]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0682; FRL-8841-9]

Spiromesifen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
spiromesifen in or on leaf petioles subgroup 4B, dry pea seed,
spearmint tops, and peppermint tops. The Interregional Research Project
Number 4 (IR-4) and Bayer CropScience requested these tolerances under
the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 1, 2010. Objections and
requests for hearings must be received on or before November 1, 2010,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0682. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division,
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703) 308-9367; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

B. How Can I Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr.

C. How Can I File an Objection or Hearing Request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must

identify docket ID number EPA-HQ-OPP-2009-0682 in the subject line on
the first page of your submission. All objections and requests for a
hearing must be in writing, and must be received by the Hearing Clerk
on or before November 1, 2010. Addresses for mail and hand delivery of
objections and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2009-0682, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of March 24, 2010 (75 FR 14156) (FRL-8815-
6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP)
0E7684 by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 08540
and PP 9F7602 by Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box
12014, Research Triangle Park, NC 27709. The petitions requested that
40 CFR 180.607 be amended by establishing tolerances for residues of
the insecticide spiromesifen, 2-oxo-3-(2,4,6-trimethylphenyl)-1-
oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate, and its enol
metabolite, 4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-
en-2-one, calculated as parent compound equivalents, in or on pea, dry,
seed at 0.15 parts per million (ppm); spearmint, tops at 25 ppm; and
peppermint, tops at 25 ppm (PP 0E7684) and vegetable, leafy petiole,
crop subgroup 4B at 6.0 ppm (PP 9F7602). The notice referenced
summaries of the petitions prepared by Bayer CropScience, the
registrant, which is available in the docket, http://
www.regulations.gov. There were no comments received in response to the
notice of filing.
    Based upon review of the data supporting the petition, EPA has
recommended for tolerances levels different from those proposed in the
petitions for dry pea seed, spearmint tops, and peppermint tops. The
reason for these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for spiromesifen including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with spiromesifen
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Spiromesifen shows low acute toxicity via the oral, dermal and
inhalation routes of exposure. It was neither an eye nor dermal
irritant, but showed moderate potential as a contact sensitizer. In
short- and long-term animal toxicity tests, the critical effects
observed were loss of body weight, adrenal effects (discoloration,
decrease in fine vesiculation, and the presence of cytoplasmic
eosinophilia in zona fasciculata cells), thyroid effects (increased
thyroid stimulating hormone, increased thyroxine binding capacity,
decreased T3 and T4 levels, colloidal alteration and thyroid follicular
cell hypertrophy), liver effects (increased alkaline phosphatase, ALT
and decreased cholesterol, triglycerides), and spleen effects (atrophy,
decreased spleen cell count, and increased macrophages). Spiromesifen
shows no significant developmental or reproductive effects, is not
likely to be carcinogenic based on bioassays in rats and mice, and
lacks in vivo and in vitro mutagenic effects. Spiromesifen is not
considered a neurotoxic chemical based on the chemical's mode of action
and the available data from multiple studies, including acute and
subchronic neurotoxicity studies.
    Specific information on the studies received and the nature of the
adverse effects caused by spiromesifen as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://
www.regulations.gov in the document titled ``Spiromesifen: Human-Health
Risk Assessment for Proposed Section 3 Uses on Leaf Petioles Subgroup
4B; Pea, Dry, Seed; Spearmint, Tops; and Peppermint, Tops'' on pages 22
to 26 in docket ID number EPA-HQ-OPP-2009-0682.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern

are identified (the LOAEL). Uncertainty/safety factors are used in
conjunction with the POD to calculate a safe exposure level - generally
referred to as a population-adjusted dose (PAD) or a reference dose
(RfD) - and a safe margin of exposure (MOE). For non-threshold risks,
the Agency assumes that any amount of exposure will lead to some degree
of risk. Thus, the Agency estimates risk in terms of the probability of
an occurrence of the adverse effect expected in a lifetime. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see http://
www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for spiromesifen used for
human risk assessment is shown in the Table of this unit.

                      Table --Summary of Toxicological Doses and Endpoints for Spiromesifen for Use in Human Health Risk Assessment
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                              Point of Departure and Uncertainty/
              Exposure/Scenario                         Safety Factors             RfD, PAD, LOC for Risk Assessment    Study and Toxicological Effects
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acute dietary                                             An endpoint of concern
 (general population and all population        attributable to a single dose was
 subgroups..................................     not identified. An aRfD was not
                                                                    established.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chronic dietary                                   NOAEL= 2.2 mg/kg/day UFA = 10x       Chronic RfD = 0.022 mg/kg/day  2-generation reproduction study in
(All populations)...........................                           UFH = 10x              cPAD = 0.022 mg/kg/day                               rats.
                                                                    FQPA SF = 1x                                       The parental systemic LOAEL: 13.2
                                                                                mg/kgbw/day based on significantly
                                                                                decreased spleen weight (absolute
                                                                                and relative in parental females
                                                                                and F1 males) and significantly
                                                                                decreased growing ovarian
                                                                                follicles in females.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cancer
(Oral, dermal, inhalation)..................               Spiromesifen has been classified as ``not likely to be carcinogenic to humans.''
--------------------------------------------------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).
  UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. UFDB = to account for the absence of data
  or other data deficiency. FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD =
  reference dose. MOE = margin of exposure. LOC = level of concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to spiromesifen, EPA considered exposure under the petitioned-
for tolerances as well as all existing spiromesifen tolerances in 40
CFR 180.607. EPA assessed dietary exposures from spiromesifen in food
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for spiromesifen; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 Cummulative Survey of Food Intake by Individuals. As to
residue levels in food, EPA assumed tolerance-level residues for all
commodities except for the leafy-greens and leafy Brassica greens
subgroups (4A and 5B). The tolerance values for leafy vegetables and
spearmint and peppermint tops and oil were adjusted upward to account
for the metabolite BSN 2060-4-hydroxymethyl (free and conjugated),
which is a residue of concern in leafy vegetables for risk assessment
purposes only. EPA used data from the lettuce metabolism studies to
create a tolerance-equivalent value for the parent spiromesifen and the
BSN 2060-4-hydroxymethyl metabolite to estimate residues in leafy
crops. Dietary Exposure Evaluation Model (DEEM) 7.81 default processing
factors and 100 percent crop treated were assumed for all commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that spiromesifen does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for spiromesifen. As discussed above, for the leafy-
greens and leafy Brassica greens subgroups (4A and 5B) and spearmint
and peppermint tops and oil, the residue values were adjusted upward to
account for the metabolite BSN 2060-4-hydroxymethyl (free and
conjugated).
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for spiromesifen in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of spiromesifen. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model /Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models the estimated drinking water concentrations (EDWCs) of
spiromesifen for chronic exposures for non-cancer assessments are
estimated to

be 188 ppb for surface water and 86 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 188 ppb was used to assess
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Spiromesifen is not
registered for any specific use patterns that would result in
residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found spiromesifen to share a common mechanism of
toxicity with any other substances, and spiromesifen does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
spiromesifen does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://
www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There is no evidence of
increased susceptibility of rats or rabbits to in utero and/or
postnatal exposure to spiromesifen. In the prenatal developmental
toxicity studies in rats and rabbits and in the 2-generation
reproduction study in rats, developmental toxicity to the offspring
occurred at equivalent or higher doses than parental toxicity.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for spiromesifen is complete and no
additional immunotoxicity or neurotoxicty testing is required. The
rationale is described below:
    a. Because spleen effects were seen in several toxicity studies,
the registrant pursued specialized immunotoxicity studies in rats and
mice that were both negative. These studies satisfy the revised 40 CFR
part 158 requirement for immunotoxicity testing. In addition, the
endpoints selected for the risk assessment are considered protective of
any possible immunotoxic effects.
    b. There is no concern for neurotoxicity resulting from exposure to
spiromesifen. Neurotoxic effects such as reduced motility, spastic
gait, increased reactivity, tremors, clonic-tonic convulsions, reduced
activity, labored breathing, vocalization, avoidance reaction,
piloerection, limp, cyanosis, squatted posture, and salivation were
observed in two studies (5-day inhalation and subchronic oral rat) at
high doses (134 and 536 milligrams/kilogram/day (mg/kg/day),
respectively). These effects were neither reflected in
neurohistopathology nor in other studies. Because these effects were
not observed in the acute and subchronic neurotoxicity studies, they
were not considered reproducible. Thus, based on the chemical's mode of
action and the available data from multiple studies, the chemical is
not considered neurotoxic.
    ii. There is no evidence that spiromesifen results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study. A developmental neurotoxicity study is not required.
    iii. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to spiromesifen in drinking water. These assessments
will not underestimate the exposure and risks posed by spiromesifen.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
spiromesifen is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
spiromesifen from food and water will utilize 78% of the cPAD for all
infants <1 year old, the population group receiving the greatest
exposure. There are no residential uses for spiromesifen.
    3. Short- and intermediate-term risk. Short-term and intermediate-
term aggregate exposure takes into account short-term and intermediate-
term residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    A short-term and intermediate-term adverse effect was identified;
however, spiromesifen is not registered for any use patterns that would
result in short-term or intermediate-term residential exposure. Short-
term and intermediate-term risk is assessed based on short-term and
intermediate-term residential exposure plus chronic dietary exposure.
Because there is no short-term or intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess short-term and intermediate-term risk), no
further assessment of short-term or intermediate-term risk is
necessary, and EPA relies on the chronic dietary risk assessment for
evaluating short-term and intermediate-term risk for spiromesifen.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two

adequate rodent carcinogenicity studies, spiromesifen is not expected
to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to spiromesifen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high-performance liquid
chromatography/mass spectroscopy (HPLC/MS/MS)/Method 00631/M001 and
Method 110333) is available to enforce the tolerance expression. The
method may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
     No Codex or Canadian MRLs have been established for spiromesifen
in/on leaf petioles subgroup 4B; pea, dry, seed; spearmint, tops; and
peppermint, tops.

C. Revisions to Petitioned-For Tolerances

    Pea, dry, seed: The Agency is modifying the tolerance from the
proposed level of 0.15 to 0.20. The adjusted field trial data for dry
peas were evaluated using the Agency's maximum-likelihood estimation
(MLE) spreadsheet and then the Agency's maximum-residue limit (MRL)
tolerance spreadsheet as described in the Guidance for Setting
Pesticide Tolerances Based on Field Trial Data SOP to determine the
appropriate tolerance level. The tolerance spreadsheet recommended a
tolerance of 0.20 ppm for total residues of spiromesifen in/on dry
peas.
    Spearmint, tops and peppermint, tops: The Agency is modifying the
tolerances from the proposed level of 25 ppm to 45 ppm. The adjusted
field trial data for mint were evaluated using the Agency's MRL
tolerance spreadsheet as described in the Guidance for Setting
Pesticide Tolerances Based on Field Trial Data SOP to determine the
appropriate tolerance level. The tolerance spreadsheet recommended a
tolerance of 45 ppm for total residues of spiromesifen for both
spearmint and peppermint tops.
    Finally, EPA has revised the tolerance expression to clarify:
    1. That, as provided in FFDCA section 408(a)(3), the tolerance
covers metabolites and degradates of spiromesifen not specifically
mentioned; and
    2. That compliance with the specified tolerance levels is to be
determined by measuring only the specific compounds mentioned in the
tolerance expression.

V. Conclusion

    Therefore, tolerances are established for residues of the
insecticide/miticide spiromesifen, including its metabolites and
degradates, determined by measuring only the sum of spiromesifen [2-
oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-
dimethylbutanoate], its enol metabolite (4-hydroxy-3-(2,4,6-
trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one), calculated as the
stoichiometric equivalent of spiromesifen, in or on pea, dry, seed at
0.20 ppm; spearmint, tops at 45 ppm; peppermint, tops at 45 ppm; and
leaf petiole subgroup 4B at 6.0 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of

Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: August 20, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Program.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Section 180.607 is amended by alphabetically adding the following
commodities to the table in paragraph (a)(1) and revising paragraphs
(a)(1) introductory text, (a)(2) introductory text, (b) introductory
text, and (d) introductory text to read as follows:

Sec.  180.607  Spiromesifen; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the
insecticide/miticide spiromesifen, including its metabolites and
degradates, in or on the commodities listed below. Compliance with the
tolerance levels specified below is to be determined by measuring only
the sum of spiromesifen [2-oxo-3-(2,4,6-trimethylphenyl)-1-
oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate] and 4-hydroxy-3-
(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one, calculated as
the stoichiometric equivalent of spiromesifen, in or on the following
primary crop commodities:

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Leaf petiole subgroup 4B.......................                      6.0
                                * * * * *
Pea, dry, seed.................................                     0.20
Peppermint, tops...............................                       45
Spearmint, tops................................                       45
                                * * * * *
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the insecticide/
miticide spiromesifen, including its metabolites and degradates, in or
on the commodities listed below. Compliance with the tolerance levels
specified below is to be determined by measuring only the sum of
spiromesifen [2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-
4-yl 3,3-dimethylbutanoate] and its metabolites containing the 4-
hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one and 4-
hydroxy-3-[4-(hydroxymethyl)-2,6-dimethylphenyl]-1-oxaspiro[4.4]non-3-
en-2-one moieties, calculated as the stoichiometric equivalent of
spiromesifen, in the following livestock commodities:
* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances
specified in the following table are established for residues of the
insecticide/miticide spiromesifen, including its metabolites and
degradates, in or on the commodities listed below. Compliance with the
tolerance levels specified below is to be determined by measuring only
the sum of spiromesifen [2-oxo-3-(2,4,6-trimethylphenyl)-1-
oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate] and 4-hydroxy-3-
(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one, calculated as
the stoichiometric equivalent of spiromesifen, in or on the specified
agricultural commodities, resulting from use of the pesticide pursuant
to FIFRA section 18 emergency exemptions. The tolerances expire and are
revoked on the date specified in the table.
* * * * *
    (d) Indirect or inadvertent residues. Tolerances are established
for the inadvertent or indirect residues of the insecticide/miticide
spiromesifen, including its metabolites and degradates, in or on the
commodities listed below. Compliance with the tolerance levels
specified below is to be determined by measuring only the sum of
spiromesifen [2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-
4-yl 3,3-dimethylbutanoate], 4-hydroxy-3-(2,4,6-trimethylphenyl)-1-
oxaspiro[4.4]non-3-en-2-one, and its metabolites containing the 4-
hydroxy-3-[4-(hydroxymethyl)-2,6-dimethylphenyl]-1-oxaspiro[4.4]non-3-
en-2-one moiety, calculated as the stoichiometric equivalent of
spiromesifen, in the following rotational crop commodities:
* * * * *
[FR Doc. 2010-21686 Filed 8-31-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 77, Number 71 (Thursday, April 12, 2012)]
[Notices]
[Pages 21977-21978]
[FR Doc No: 2012-8819]

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

Federal Energy Regulatory Commission

[Project No. 13305-002]

 Whitestone Power and Communications; Notice Concluding Pre-
Filing Process and Approving Process Plan and Schedule

    a. Type of Filing: Notice of Intent To File an Application for a
Hydrokinetic Pilot Project License.
    b. Project No.: 13305-002.
    c. Date Filed: August 22, 2011.
    d. Submitted By: Whitestone Power and Communications (Whitestone).
    e. Name of Project: Microturbine Hydrokinetic River-In-Stream
Energy Conversion Power Project.
    f. Location: On the Tanana River near Delta Junction, Alaska. The
project would not occupy any federal lands.
    g. Filed Pursuant to: 18 CFR 5.3 and 5.5 of the Commission's
regulations.
    h. Applicant Contact: Steven M. Selvaggio, Whitestone Power and
Communications, P.O. Box 1630, Delta Junction, Alaska 99737; (907) 895-
4938.
    i. FERC Contact: Dianne Rodman;<PHONE_NUMBER>.
    j. Whitestone has filed with the Commission: (1) A notice of intent
(NOI) to file an application for a pilot hydrokinetic hydropower
project and a draft license application with monitoring plan; (2) a
request for waiver of certain Integrated Licensing Process (ILP)
regulations necessary for expedited processing of a license application
for a hydrokinetic pilot project; (3) a proposed process plan and
schedule; and (4) a request to be designated as the non-federal
representative for section 7 of the Endangered Species Act (ESA)
consultation and for section 106 consultation under the National
Historic Preservation Act.
    k. A notice was issued on August 25, 2011, soliciting comments on
the draft license application from agencies and stakeholders. Comments
were filed by the Alaska Department of Fish and Game.
    l. Whitestone was designated as the non-federal representative for
section 7 of the Endangered Species Act consultation and for section
106 consultation under the National Historic Preservation Act on
January 21, 2011.
    m. The proposed Microturbine Hydrokinetic River-In-Stream Energy
Conversion Power Project would consist of: (1) A 12-foot-wide, 16-foot-
diameter Poncelet undershot water wheel; (2) a 34-foot-long, 19- to 24-
foot-wide aluminum-frame floatation platform mounted on a 34-foot-long,
3.5-foot-diameter high-density- polyethylene (HDPE) pontoon and a 34-
foot-long, 3-foot-diameter HDPE pontoon; (3) a 100-kilowatt turbine/
generator unit; (4) a 33-foot-long, 3.5-foot-wide gangway from the
shore to the floating pontoon; (5) three anchoring cables to secure the
flotation platform to the shore, including a 30-foot-long primary
safety tether, a 117-foot-long primary cable, and a 100-foot-long
secondary cable; (6) an approximately 900-foot-long transmission cable
from the floatation platform to an existing Golden Valley Electric
Association distribution line; and (7) appurtenant facilities. The
project is anticipated to operate from April until October, with an
estimated annual generation of 200 megawatt-hours.
    n. The pre-filing process has been concluded and the requisite
regulations have been waived such that the process and schedule
indicated below can be implemented.
    o. Post-filing process schedule. The post-filing process will be
conducted pursuant to the following schedule. Revisions to the schedule
may be made as needed.

------------------------------------------------------------------------
              Milestones                             Dates
------------------------------------------------------------------------
Final license application expected...  April 17, 2012.
Issue notice of acceptance and ready   May 2, 2012.
 for environmental analysis and
 request for interventions.

Recommendations, Conditions, Comments  June 1, 2012.
 and Interventions due.
Issue notice of availability of        July 31, 2012.
 environmental assessment.
Comments due and 10(j) resolution, if  August 30, 2012.
 needed.
------------------------------------------------------------------------

    p. Register online at http://ferc.gov/esubscribenow.htm to be
notified via email of new filing and issuances related to this or other
pending projects. For assistance, contact FERC Online Support.

    Dated: April 5, 2012.
Kimberly D. Bose,
 Secretary.
[FR Doc. 2012-8819 Filed 4-11-12; 8:45 am]
BILLING CODE 6717-01-P