[Federal Register Volume 84, Number 149 (Friday, August 2, 2019)]
[Notices]
[Pages 37945-37946]
[FR Doc No: 2019-16527]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2019-0291]

Agency Information Collection Activities: Requests for Comments;
Clearance of a Renewed Approval of Information Collection: Notice of
Proposed Construction or Alteration, Notice of Actual Construction or
Alteration

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The Federal Register Notice with a 60-day comment period
soliciting comments on the following collection of information was
published on April 22, 2019. The FAA uses the Information collected on
form 7460-1 to determine the effect a proposed construction or
alteration would have on air navigation and the National Airspace
System (NAS) and the information collected on form 7460-2 to measure
the progress of actual construction.

DATES: Written comments should be submitted by September 3, 2019.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, Docket Library, Room 10102, 725 17th Street NW, Washington,
DC 20503.

FOR FURTHER INFORMATION CONTACT: Dave Maddox by email at:
<EMAIL_ADDRESS>phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.
    OMB Control Number: 2120-0001.
    Title: Notice of Proposed Construction or Alteration, Notice of
Actual Construction or Alteration.
    Form Numbers: FAA forms 7460-1 and 7460-2.
    Type of Review: Renewal of an information collection.
    Background: The Federal Register Notice with a 60-day comment
period soliciting comments on the following collection of information
was published on April 22, 2019, (84 FR 16758). 49 U.S.C. 44718 states
that the Secretary of Transportation shall require notice of

structures that may affect navigable airspace, air commerce, or air
capacity. These notice requirements are contained in 14 CFR 77. The
information is collected via FAA forms 7460-1 and 7460-2.
    Respondents: Approximately 85,000 registered respondents including
individuals or organizations that propose construction or alteration
projects and are required to provide adequate notification to the FAA
of that construction or alteration.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: Approximately 15 minutes.
    Estimated Total Annual Burden: 70,075 hours.

    Issued in Washington, DC, on July 30, 2019.
Michael Helvey,
Manager, Obstruction Evaluation Group, AJV-15.
[FR Doc. 2019-16527 Filed 8-1-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 200 (Wednesday, October 20, 2021)]
[Notices]
[Page 58130]
[FR Doc No: 2021-22798]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-93331; File Nos. SR-NYSE-2021-14, SR-NYSEAMER-2021-10,
SR-NYSEArca-2021-13, SR-NYSECHX-2021-03, SR-NYSENAT-2021-04]

Self-Regulatory Organizations; New York Stock Exchange LLC, NYSE
American LLC, NYSE Arca, Inc., NYSE Chicago, Inc., and NYSE National,
Inc.; Notice of Withdrawal of Proposed Rule Changes To Amend the
Schedule of Wireless Connectivity Fees and Charges To Add Connectivity
Services Available at the Data Center in Mahwah, New Jersey

October 14, 2021.
    On February 12, 2021, New York Stock Exchange LLC, NYSE American
LLC, NYSE Arca, Inc., NYSE Chicago, Inc., and NYSE National, Inc.
(collectively, the ``Exchanges'') each filed with the Securities and
Exchange Commission (``Commission''), pursuant to Section 19(b)(1) of
the Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to (1) add circuits for
connectivity into and out of the data center in Mahwah, New Jersey
(``Mahwah Data Center''); (2) add services available to customers of
the Mahwah Data Center that are not colocation Users; and (3) change
the name of the Fee Schedule to ``Mahwah Wireless, Circuits, and Non-
Colocation Connectivity Fee Schedule.''
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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    The proposed rule changes were published for comment in the Federal
Register on March 4, 2021.\3\ On April 7, 2021, pursuant to Section
19(b)(2) of the Act,\4\ the Commission designated a longer period
within which to approve the proposed rule changes, disapprove the
proposed rule changes, or institute proceedings to determine whether to
disapprove the proposed rule changes.\5\ On May 26, 2021, the
Commission instituted proceedings under Section 19(b)(2)(B) of the Act
\6\ to determine whether to approve or disapprove the proposed rule
changes.\7\ On August 27, 2021, pursuant to Section 19(b)(2) of the
Act,\8\ the Commission designated a longer period for Commission action
on the proceedings to determine whether to approve or disapprove the
proposed rule changes.\9\ The Commission has received comments on the
proposed rule changes.\10\ On October 12, 2021, the Exchanges withdrew
the proposed rule changes (SR-NYSE-2021-14, SR-NYSEAMER-2021-10, SR-
NYSEArca-2021-13, SR-NYSECHX-2021-03, SR-NYSENAT-2021-04).
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    \3\ See Securities Exchange Act Release Nos. 91217 (February 26,
2021), 86 FR 12715 (March 4, 2021) (SR-NYSE-2021-14); 91218
(February 26, 2021), 86 FR 12744 (March 4, 2021) (SR-NYSEAMER-2021-
10); 91216 (February 26, 2021), 86 FR 12735 (March 4, 2021) (SR-
NYSEArca-2021-13); 91219 (February 26, 2021), 86 FR 12724 (March 4,
2021) (SR-NYSECHX-2021-03); and 91215 (February 26, 2021), 86 FR
12752 (March 4, 2021) (SR-NYSENAT-2021-04).
    \4\ 15 U.S.C. 78s(b)(2).
    \5\ See Securities Exchange Act Release No. 91490 (April 7,
2021), 86 FR 19313 (April 13, 2021).
    \6\ 15 U.S.C. 78s(b)(2)(B).
    \7\ See Securities Exchange Act Release No. 92033 (May 26,
2021), 86 FR 29601 (June 2, 2021).
    \8\ 15 U.S.C. 78s(b)(2).
    \9\ See Securities Exchange Act Release No. 92795 (August 27,
2021), 86 FR 49393 (September 2, 2021).
    \10\ Comments received on the proposed rule changes are
available at: https://www.sec.gov/comments/sr-nyse-2021-14/srnyse202114.htm.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-22798 Filed 10-19-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: October 25, 2011 (Volume 76, Number 206)]
[Notices]
[Page 66060-66061]
[DOCID:fr25oc11-63]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Commission Staff Attendance

    The Federal Energy Regulatory Commission hereby gives notice that
members of the Commission's staff may attend the following meetings
related to the transmission planning activities of the New York
Independent System Operator, Inc. (NYISO):

Electric System Planning Working Group

October 24, 2011, 10 a.m.-4:00 p.m., Local Time
November 7, 2011, 10 a.m.-4 p.m., Local Time
November 21, 2011, 10 a.m.-4 p.m., Local Time

Inter-Regional Planning Advisory Committee

November 29, 2011, 8:30 a.m.-12:30 p.m., Local Time

    The above-referenced meetings will be held at: NYISO's offices,
Rensselaer, NY.
    The above-referenced meetings are open to stakeholders.
    Further information may be found at http://www.nyiso.com.
    The discussions at the meeting described above may address matters
at issue in the following proceedings:
    Docket No. RM10-23, Transmission Planning and Cost Allocation by
Transmission Owning and Operating Public Utilities
    Docket No. ER08-1281, New York Independent System Operator, Inc.
    For more information, contact James Eason, Office of Energy Market
Regulation, Federal Energy Regulatory Commission at<PHONE_NUMBER> or
<EMAIL_ADDRESS>
    Dated: October 19, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-27527 Filed 10-24-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: July 29, 2008 (Volume 73, Number 146)]
[Notices]
[Page 43963]
[DOCID:fr29jy08-89]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on July 31, 2008 at
2 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), (9)(B), and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the
scheduled matters at the Closed Meeting.
    Commissioner Walter, as duty officer, voted to consider the items
listed for the Closed Meeting in closed session.
    The subject matter of the Closed Meeting scheduled for July 31,
2008 will be: Formal orders of investigation; institution and
settlement of injunctive actions; institution and settlement of
administrative proceedings of an enforcement nature; resolution of
litigation claims; and other matters related to enforcement
proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

    Dated: July 24, 2008.
Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-17414 Filed 7-28-08; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 86, Number 69 (Tuesday, April 13, 2021)]
[Notices]
[Pages 19313-19316]
[FR Doc No: 2021-07493]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-91494; File No. SR-CboeEDGX-2021-018]

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

April 7, 2021.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on April 1, 2021, Cboe EDGX Exchange, Inc. (the ``Exchange'' or
``EDGX'') filed with the

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

    Cboe EDGX Exchange, Inc. (the ``Exchange'' or ``EDGX'') is filing
with the Securities and Exchange Commission (``Commission'') a proposed
rule change to amend the fee schedule. The text of the proposed rule
change is provided in Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/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 Exchange proposes to amend its fee schedule applicable to its
equities trading platform (``EDGX Equities'') to include an additional
Remove Volume Tier. The Exchange proposes to implement the proposed
change to its fee schedule on April 1, 2021.
    The Exchange first notes that it operates in a highly competitive
market in which market participants can readily direct order flow to
competing venues if they deem fee levels at a particular venue to be
excessive or incentives to be insufficient. More specifically, the
Exchange is only one of 16 registered equities exchanges, as well as a
number of alternative trading systems and other off-exchange venues
that do not have similar self-regulatory responsibilities under the
Exchange Act, to which market participants may direct their order flow.
Based on publicly available information,\3\ no single registered
equities exchange has more than 16% of the market share. Thus, in such
a low-concentrated and highly competitive market, no single equities
exchange possesses significant pricing power in the execution of order
flow. The Exchange in particular operates a ``Maker-Taker'' model
whereby it pays credits to members that add liquidity and assesses fees
to those that remove liquidity. The Exchange's fee schedule sets forth
the standard rebates and rates applied per share for orders that
provide and remove liquidity, respectively. Additionally, in response
to the competitive environment, the Exchange also offers tiered pricing
which provides Members opportunities to qualify for higher rebates or
reduced fees where certain volume criteria and thresholds are met.
Tiered pricing provides an incremental incentive for Members to strive
for higher tier levels, which provides increasingly higher benefits or
discounts for satisfying increasingly more stringent criteria.
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    \3\ See Cboe Global Markets, U.S. Equities Market Volume
Summary, Month-to-Date (March 29, 2021), available at https://markets.cboe.com/us/equities/market_statistics/.
---------------------------------------------------------------------------

    Pursuant to footnote 1 of the Fee Schedule, the Exchange offers a
Remove Volume Tier that provides a reduced fee to Members meeting
certain volume thresholds. Now, the Exchange is proposing to rename the
existing Remove Volume Tier to Remove Volume Tier 1, and add an
additional Remove Volume Tier 2. The proposed Remove Volume Tier 2
offers a reduced fee of $0.0026 for orders in securities at or above
$1.00 and 0.28% of total dollar value for orders in securities below
$1.00 yielding fee code ``N'',\4\ ``W'',\5\ and ``BB'' \6\ where a
Member has (1) a Step-Up Add TCV \7\ from January 2021 equal to or
greater than 0.15%; (2) an ADAV \8\ greater than or equal to 0.08% of
the TCV \9\ for Non-Displayed orders that yield fee codes DM,\10\
HA,\11\ HI,\12\ MM,\13\ or RP; \14\ and (3) removes an ADV \15\ greater
than or equal to 0.75% of the TCV. The proposed Remove Volume Tier 2 is
designed to incentivize Members to increase their orders that add
liquidity on the Exchange for displayed and non-displayed orders, as
well as remove displayed volume on the Exchange in order to receive a
reduced fee on their qualifying, liquidity removing orders.
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    \4\ Orders yielding Fee Code ``N'' are orders removing liquidity
from EDGX (Tape C).
    \5\ Orders yielding Fee Code ``W'' are orders removing liquidity
from EDGX (Tape A).
    \6\ Orders yielding Fee Code ``BB'' are orders removing
liquidity from EDGX (Tape B).
    \7\ Step-Up Add TCV means ADAV as a percentage of TCV in the
relevant baseline month subtracted from current ADAV as a percentage
of TCV.
    \8\ ADAV means average daily added volume calculated as the
number of shares added per day.
    \9\ 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.
    \10\ Orders yielding Fee Code ``DM'' are orders adding liquidity
using MidPoint Discretionary order within discretionary range.
    \11\ Orders yielding Fee Code ``HA'' are Non-Displayed orders
adding liquidity.
    \12\ Orders yielding Fee Code ``HI'' are Non-Displayed orders
that receive price improvement and add liquidity.
    \13\ Orders yielding Fee Code ``MM'' are Non-Displayed orders
adding liquidity using MidPoint Peg.
    \14\ Orders yielding Fee Code ``RP'' are Non-Displayed orders
adding liquidity using Supplemental Peg.
    \15\ 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.
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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of Section 6 of the Act,\16\ in general, and
furthers the objectives of Section 6(b)(4),\17\ in particular, as it is
designed to provide for the equitable allocation of reasonable dues,
fees and other charges among its Members, issuers and other persons
using its facilities. 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 changes
reflect a competitive pricing structure designed to incentivize market
participants to direct their order flow to the Exchange, which the
Exchange believes would enhance market quality to the benefit of all
Members. The Exchange notes that relative volume-based incentives and
discounts have been widely adopted by exchanges, including the
Exchange, 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. Competing equity exchanges offer similar tiered
pricing structures,

including schedules of rebates and fees that apply based upon members
achieving certain volume and/or growth thresholds, as well as assess
similar fees or rebates for similar types of orders, to that of the
Exchange.
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    \16\ 15 U.S.C. 78f.
    \17\ 15 U.S.C. 78f(b)(4).
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    The Exchange believes the proposed addition to the Remove Volume
Tiers is reasonable because it provides an additional opportunity for
Members to receive a discounted rate for liquidity removing orders. The
Exchange notes the proposed tier is available to all Members and is
competitively achievable for all Members that submit the requisite
order flow, in that, all firms are eligible for the proposed tier and
those that submit the requisite order flow could compete to meet the
proposed tier. Each Member will uniformly receive the respective
proposed reduced fee if the corresponding tier criteria is met.
    The Exchange believes the Remove Volume Tier is a reasonable means
to incentivize Members to continue to provide liquidity adding,
displayed volume to the Exchange by offering them a different,
additional opportunity than that of the Add Volume Tiers--to receive a
reduced fee on their liquidity removing orders by meeting the proposed
criteria in submitting additional add volume order flow.
    Overall, the Exchange believes that adding new tier criteria each
based on a Member's liquidity adding and removing orders, will benefit
all market participants by incentivizing continuous liquidity and thus,
deeper more liquid markets as well as increased execution
opportunities. Particularly, the proposed tier is designed to
incentivize Members to increase their orders that add displayed and
non-displayed volume on the Exchange in order to receive a reduced fee
on their qualifying, liquidity removing orders. This overall increase
in activity deepens the Exchange's liquidity pool, offers additional
cost savings, supports the quality of price discovery, promotes market
transparency and improves market quality, for all investors.
    Without having a view of 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 the
proposed tiers. While the Exchange has no way of predicting with
certainty how the proposed tiers will impact Member activity, the
Exchange anticipates that for the proposed Remove Volume Tier 2 at
least one Member will be able to compete for and achieve the proposed
criteria. The Exchange notes, however, that the proposed tier is open
to any Member that satisfies the tier's criteria. The Exchange also
notes that the proposed tier will not adversely impact any Member's
pricing or their ability to qualify for other tiers. Rather, should a
Member not meet the proposed criteria for the proposed tier, the Member
will merely not receive the corresponding reduced fee.

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

    The Exchange does not believe that the proposed rule changes will
impose any burden on competition 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 order flow to a public exchange, thereby
promoting market depth, execution incentives and enhanced execution
opportunities, as well as price discovery and transparency for all
Members. As a result, the Exchange believes that the proposed 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.''
    The Exchange believes the proposed rule change does not 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 to all Members equally in that all Members are eligible
for the proposed Remove Volume Tier 2 and have a reasonable opportunity
to meet the tier's criteria and will all receive the proposed reduced
fee if such criteria is met. Additionally, the proposed tier is
designed to attract additional order flow to the Exchange. The Exchange
believes that the additional tier criteria would incentivize market
participants to direct liquidity adding and removing order flow to the
Exchange, bringing with it improved price transparency. Greater overall
order flow and pricing transparency benefits all market participants on
the Exchange by providing more trading opportunities, enhancing market
quality, and continuing to encourage Members to send orders, thereby
contributing towards a robust and well-balanced market ecosystem, which
benefits all market participants.
    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 other equities exchanges, off-
exchange venues, and alternative trading systems. Additionally, the
Exchange represents a small percentage of the overall market. Based on
publicly available information, no single equities exchange has more
than 16% of the market share.\18\ Therefore, no exchange possesses
significant pricing power in the execution of order flow. Indeed,
participants can readily choose to send their orders to other exchange
and off-exchange venues if they deem fee levels at those other venues
to be more favorable. Moreover, the Commission has repeatedly expressed
its preference for competition over regulatory intervention in
determining prices, products, and services in the securities markets.
Specifically, in Regulation NMS, the Commission highlighted the
importance of market forces in determining prices and SRO revenues and,
also, recognized that current regulation of the market system ``has
been remarkably successful in promoting market competition in its
broader forms that are most important to investors and listed
companies.'' \19\ 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'. . . .''.\20\ Accordingly, the Exchange does not believe its
proposed fee change imposes any burden on competition that is not
necessary or appropriate in furtherance of the purposes of the Act.
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    \18\ Supra note 3.
    \19\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496, 37499 (June 29, 2005).
    \20\ NetCoalition v. SEC, 615 F.3d 525, 539 (D.C. Cir. 2010)
(quoting Securities Exchange Act Release No. 59039 (December 2,
2008), 73 FR 74770, 74782-83 (December 9, 2008) (SR-NYSEArca-2006-
21)).

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

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

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \21\ and paragraph (f) of Rule 19b-4 \22\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
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    \21\ 15 U.S.C. 78s(b)(3)(A).
    \22\ 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-2021-018 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-2021-018. 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-2021-018 and should be
submitted on or before May 4, 2021.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
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    \23\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-07493 Filed 4-12-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 59 (Wednesday, March 27, 2013)]
[Rules and Regulations]
[Pages 18504-18511]
[FR Doc No: 2013-06758]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0665; FRL-9381-4]

Emamectin Benzoate; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of
emamectin benzoate in or on the cucurbit vegetable crop group 9.
Interregional Research Project Number 4 (IR-4) requested this tolerance
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 27, 2013. Objections and
requests for hearings must be received on or before May 28, 2013, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2011-0665, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http:[sol][sol]www.epa.gov/dockets.

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

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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:[sol][sol]www.ecfr.gov/cgi-bin/
text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2011-0665 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
May 28, 2013. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2011-0665, by one of
the following methods:
     Federal eRulemaking Portal:
http:[sol][sol]www.regulations.gov. Follow the online instructions for
submitting comments. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http:[sol][sol]www.epa.gov/dockets/contacts.htm.

Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at
http:[sol][sol]www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of September 7, 2011 (76 FR 55329) (FRL-
8886-7), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
1E7904) by IR-4, 500 College Rd. East, Suite 201 W, Princeton, NJ
08540. The petition requested that 40 CFR 180.505 be amended by
establishing tolerances for residues of the insecticide emamectin
benzoate, 4'-epimethylamino-4'-deoxyavermectin B1 benzoate (a mixture
of a minimum of 90% 4'-epi-methylamino-4'-deoxyavermectin B1a and a
maximum of 10% 4'-epi-methlyamino-4'deoxyavermectin B1b benzoate), and
its metabolites 8,9 isomer of the B1a and B1b component of the parent
insecticide, in or on vegetable, cucurbit, group 9 at 0.03 parts per
million (ppm). That document referenced a summary of the petition
prepared by Syngenta, the registrant, which is available in the docket,
http:[sol][sol]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
modified the level at which the tolerance is being established. The
reason for this change is explained in Unit IV.C.

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 FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), 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 emamectin benzoate including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with emamectin
benzoate 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. Emamectin acts by binding to gamma-aminobutyric acid (GABA)
gated chloride channels at two different sites, a high affinity binding
site that activates the channel and a low affinity site that blocks the
channel. GABA plays a critical role in nervous system development
through both non-synaptic and synaptic mechanisms. Consequently,
emamectin may have the potential to influence GABA-mediated events
important to brain development. Within the mammalian brain, a member of
this class of compound (abamectin) has been shown to have widespread
binding but particularly abundant in the cerebellum. Through action on
the enteric nervous system and induction of longitudinal rhythmic
contractions in the isolated ileum, emamectin like abamectin may
therefore influence GABA-mediated regulation of metabolism, food intake
and body weight at multiple sites. Although GABA receptor mediated
neurotoxicity is a solid hypothesis, data in mammalian preparations
linking alterations in GABA receptor function to disruptions in
neuronal excitability in vitro and in vivo, and ultimately adverse
outcome are currently lacking.
    Integral to its mechanism of action in mammals, this class of
compounds is also a substrate for (i.e., binds to) P-glycoprotein. P-
glycoprotein (P-gp) is a member of the adenosine triphosphate (ATP)
binding cassette transporter proteins, which reside in the plasma
membrane and function as a transmembrane efflux pump, moving
xenobiotics from intracellular to the extracellular domain against a
steep concentration gradient with ATP-hydrolysis providing the energy
for active transport. P-gp is found in the canallicular surface of
hepatocytes, the apical surface of proximal tubular cells in the
kidneys, brush border surface of enterocytes, luminal surface of blood
capillaries of the brain (blood brain barrier), placenta, ovaries, and
the testes. As an efflux transporter, P-gp acts as a protective barrier
to keep xenobiotics out of the body by excreting them into bile, urine,
and intestinal lumen and prevents accumulation of these compounds in
the brain and gonads, as well as the fetus. Therefore, some test
animals, in which genetic polymorphisms compromise P-gp expression, are
particularly susceptible to abamectin or emamectin-induced
neurotoxicity. An example is the CF-1 mouse. Some CF-1 mice are
deficient in P-gp and are found to be highly sensitive to the
neurotoxicity of abamectin. A small population of humans is also found
to be deficient of ATP binding cassette (ABC) transporter proteins due
to polymorphism in the gene encoding ABC transporter proteins (Dubin-
Johnson Syndrome). In addition, collie dogs have been known to be
deficient in P-gp.
    Consistent with the mode of action, the main target organ for
emamectin is the nervous system; clinical signs (tremors, ptosis,
ataxia, and hunched posture) and neuropathology (neuronal degeneration
in the brain and in peripheral nerves, muscle fiber degeneration) were
found in most of the emamectin studies in rats, dogs and mice. The
dose/response curve was very steep in several studies (most notably
with CF-1 mice and dogs), with severe effects (morbid sacrifice and
neuropathology) sometimes seen at the LOAELs (0.1 milligram/kilogram/
day (mg/kg/day) with NOAEL of 0.075 mg/kg/day). Although no increased
sensitivity was seen in developmental toxicity studies in rats and
rabbits, increased qualitative and/or quantitative sensitivity of rat
pups was seen in the reproductive toxicity and in the developmental
neurotoxicity studies.
    The carcinogenicity and mutagenicity studies provide no indication
that emamectin is carcinogenic or mutagenic. Emamectin is classified as
``not likely to be carcinogenic to humans.''
    The available emamectin data show that there is a difference in
species sensitivity, and the data suggest the following order: Rat
NOAELs/LOAELs greater than dog NOAELs/LOAELs greater than mouse NOAELs/
LOAELs. The toxicity endpoints and points of departure for risk were
selected from the results of the 15-day CF-1 mouse oral toxicity study.
    Specific information on the studies received and the nature of the
adverse effects caused by emamectin benzoate 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 on pages 43-50 of the document titled ``Emamectin
Benzoate. Revised Human Health Risk Assessment for Proposed Uses on
Cucurbits and Outdoor-Grown Plants in Commercial Nursery Production''
in docket ID number EPA-HQ-OPP-2011-0665.

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 emamectin benzoate
used for human risk assessment is shown in Table 1 of this unit.

    Table 1--Summary of Toxicological Doses and Endpoints for Emamectin Benzoate for Use in Human Health Risk
                                                   Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure    RfD, PAD, LOC for
        Exposure/scenario            and uncertainty/    risk assessment (mg/   Study and toxicological effects
                                      safety factors           kg/day)
----------------------------------------------------------------------------------------------------------------
Acute dietary (All Populations)..  NOAEL = 0.075 mg/kg/  aRfD = 0.00025.....  15-day mouse. LOAEL = 0.1 mg/kg/
                                    day.                 aPAD = 0.00025.....   day based on tremors on day 3 of
                                   UFA = 10x...........                        dosing. At the next higher dose
                                   UFH = 10x...........                        (0.3 mg/kg/day), tremors were
                                   FQPA SF = 3x........                        seen at day 2 of treatment.
Chronic dietary (All populations)  NOAEL= 0.075 mg/kg/   cRfD = 0.000075....  15-day mouse. LOAEL = 0.1 mg/kg/
                                    day.                 cPAD = 0.000075....   day based on moribund sacrifices,
                                   UFA = 10x...........                        clinical signs of neurotoxicity,
                                   UFH = 10x...........                        decreases in body weight and food
                                   FQPA SF = 10x.......                        consumption and histopathological
                                                                               lesions in the sciatic nerve.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. mg/kg/day =
  milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c
  = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human
  (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to emamectin benzoate, EPA considered exposure under the
petitioned-for tolerances as well as all existing emamectin benzoate
tolerances in 40 CFR 180.505. EPA assessed dietary exposures from
emamectin benzoate 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.
    Such effects were identified for emamectin benzoate. In estimating
acute dietary exposure, EPA used food consumption information from the
U.S. Department of Agriculture (USDA) 2003-2008 National Health and
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As
to residue levels in food, a probabilistic acute dietary exposure
assessment was conducted. The anticipated residue estimates, used for
most crops, were based on field trial data. Tolerance-level residues
were used for tree nuts (including pistachios) and cottonseed oil.
Pesticide Data Program (PDP) monitoring data for years 2009 and 2010
were used for apples since apple juice had a significant impact on
exposure. Dietary Exposure Evaluation Model (DEEM) default processing
factors were used except for commodities with chemical-specific
processing studies. Percent crop treated (PCT) data were used.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 2003-2008
NHANES/WWEIA. As to residue levels in food, a somewhat refined chronic
dietary exposure assessment was conducted. The anticipated residue
estimates, used for most crops, were single point estimates (averages)
based on field trial data. Tolerance-level residues were used for tree
nuts (including pistachios) and cottonseed oil. DEEM default processing
factors were used except for commodities with chemical-specific
processing studies. PCT data were used.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that emamectin benzoate 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 PCT information. Section 408(b)(2)(E)
of FFDCA authorizes EPA to use available data and information on the
anticipated residue levels of pesticide residues in food and the actual
levels of pesticide residues that have been measured in food. If EPA
relies on such information, EPA must require pursuant to FFDCA section
408(f)(1) that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. For the present action,
EPA will issue such data call-ins as are required by FFDCA section
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be
required to be submitted no later than 5 years from the date of
issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    For the acute dietary assessment, the Agency estimated the PCT for
existing uses as follows:
    Almonds, 2.5%; apples, 20%; broccoli, 20%; cabbage, 25%;

cauliflower, 20%; celery, 40%; cotton, 2.5%; lettuce, 20%; pears, 20%;
peppers, 15%; spinach, 10%; tomatoes, 20%.
    For the chronic dietary assessment, the Agency estimated the PCT
for existing uses as follows:
    Almonds, 1%; apples, 10%; broccoli, 5%; cabbage, 10%; cauliflower,
10%; celery, 25%; cotton, 1%; lettuce, 10%; pears, 5%; peppers, 5%;
spinach, 5%; tomatoes, 10%.
    In most cases, EPA uses available data from USDA/National
Agricultural Statistics Service (NASS), proprietary market surveys, and
the National Pesticide Use Database for the chemical/crop combination
for the most recent 6 to 7 years. EPA uses an average PCT for chronic
dietary risk analysis. The average PCT figure for each existing use is
derived by combining available public and private market survey data
for that use, averaging across all observations, and rounding to the
nearest 5%, except for those situations in which the average PCT is
less than 1. In those cases, 1% is used as the average PCT and 2.5% is
used as the maximum PCT. EPA uses a maximum PCT for acute dietary risk
analysis. The maximum PCT figure is the highest observed maximum value
reported within the recent 6 years of available public and private
market survey data for the existing use and rounded up to the nearest
multiple of 5%.
    For the acute dietary assessment, the Agency estimated the PCT for
new uses as follows:
    Cantaloupe, 51%; cucumber, 26%; squash, 46%; watermelon, 21%.
    For the chronic dietary assessment, the Agency estimated the PCT
for new uses as follows:
    Cantaloupe, 40%; cucumber, 14%; squash, 29%; watermelon, 19%.
    EPA estimates of the PCT for new uses of emamectin benzoate
represent the upper bound of the use expected during the pesticide's
initial 5 years of registration; that is, PCT for new uses of emamectin
benzoate is a threshold of use that EPA is reasonably certain will not
be exceeded for each registered use site. The PCT recommended for use
in the chronic dietary assessment for new uses is calculated as the
average PCT of the market leader or leaders, (i.e., the pesticide(s)
with the greatest PCT) on that site over the three most recent years of
available data. The PCT recommended for use in the acute dietary
assessment for new uses is the maximum observed PCT over the same
period. Comparisons are only made among pesticides of the same
pesticide types (e.g., the market leader for insecticides on the use
site is selected for comparison with a new insecticide). The market
leader included in the estimation may not be the same for each year
since different pesticides may dominate at different times.
    Typically, EPA uses USDA/NASS as the source data because it is
publicly available and directly reports values for PCT. When a specific
use site is not reported by USDA/NASS, EPA uses proprietary data and
calculates the PCT given reported data on acres treated and acres
grown. If no data are available, EPA may extrapolate PCT for new uses
from other crops, if the production area and pest spectrum are
substantially similar.
    A retrospective analysis to validate this approach shows few cases
where the PCT for the market leaders were exceeded. Further review of
these cases identified factors contributing to the exceptionally high
use of a new pesticide. To evaluate whether the PCT for new uses for
emamectin benzoate could be exceeded, EPA considered whether there may
be unusually high pest pressure, as indicated in emergency exemption
requests for emamectin benzoate; the pest spectrum of the new pesticide
in comparison with the market leaders and whether the market leaders
are well established for that use; and whether pest resistance issues
with past market leaders provide emamectin benzoate with significant
market potential. Given currently available information, EPA concludes
that it is unlikely that actual PCT for emamectin benzoate will exceed
the estimated PCT for new uses during the next 5 years.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which emamectin benzoate may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for emamectin benzoate in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of emamectin benzoate. 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
emamectin benzoate for acute exposures are estimated to be between 0
and 0.465 parts per billion (ppb) for surface water and 0.00054 ppb for
ground water, and for chronic exposures are estimated to be 0.150 ppb
for surface water and 0.00054 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, a drinking water residue distribution based on the PRZM/
EXAMS modeling was used. For chronic dietary risk assessment, the water
concentration value of 0.150 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).
    Emamectin benzoate 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.''
    OPP's ``Guidance For Identifying Pesticide Chemicals and Other
Substances that have a Common Mechanism of Toxicity'' (Ref. 1)
describes the weight of the evidence approach for determining whether
or not a group of pesticides share a

common mechanism of toxicity. This guidance defines mechanism of
toxicity as the major steps leading to a toxic effect following
interaction of a pesticide with biological targets. All steps leading
to an effect do not need to be specifically understood. Rather, it is
the identification of the crucial events following chemical interaction
that are required in order to describe a mechanism of toxicity. For
example, a mechanism of toxicity may be described by knowing the
following: A chemical binds to a given biological target in vitro, and
causes the receptor-related molecular response; in vivo it also leads
to the molecular response and causes a number of intervening biological
and morphological steps that result in an adverse effect. In this
context a common mechanism of toxicity pertains to two or more
pesticide chemicals or other substances that cause a common toxic
effect to human health by the same, or essentially the same, sequence
of major biochemical events. Hence, the underlying basis of the
toxicity is the same, or essentially the same, for each chemical. In
the case of the macrocyclic lactone pesticides (e.g., abamectin,
emamectin, and avermectin), there is a wealth of data on the
insecticidal mechanism of action for avermectin: Its insecticidal
actions are mediated by interaction with the glutamate-gated chloride
channels and GABAA gated chloride channels. This is presumed
to be the insecticidal mechanism of action of emamectin and abamectin
as well. Insecticidal mechanism of action does not indicate a common
mechanism of toxicity for human health. Further, mammals lack
glutamate-gated chloride channels; the toxic actions of avermectin
appear to be mediated via interaction with GABAA and
possibly glycine gated chloride channels. There is evidence that
avermectin B1a binds to GABAA receptors and
activates Cl\-\ flux into neurons (Refs. 2 and 3). However, there is a
paucity of data regarding the resultant alterations in cellular
excitability of mammalian neurons and neural networks (i.e., changes in
cellular excitability and altered network function as documented with
pyrethroids), as well as in vivo measurements of altered excitability
associated with adverse outcomes. Thus, while the downstream steps
leading to toxicity via disruption of GABAA receptor
function for avermectin can be postulated, experimental data supporting
these actions are lacking. In addition, specific data demonstrating
GABAA receptor interaction in mammalian preparations are
lacking for abamectin and emamectin. Moreover, the specificity of such
interaction on the adverse outcome would need to be shown
experimentally. GABAA receptors have multiple binding sites
which have been proposed to relate to adverse outcomes. For example,
Dawson et al. (Ref. 4) showed for a group of avermectin-like compounds
that rank order for anticonvulsant activity did not parallel the rank
order for affinity at the [3H]ivermectin site. The authors hypothesized
that these findings may be related to differential affinity or efficacy
at subtypes of the GABAA receptor. Other reports have
indicated species differences in abamectin effects on GABAA
receptor function in the mouse as compared to the rat (Ref. 5).
    In conclusion, although GABAA receptor mediated
neurotoxicity may be a common mechanism endpoint for the macrocyclic
lactone pesticides, data demonstrating the interactions of emamectin
and abamectin with mammalian GABAA receptors are not
available, and data in mammalian preparations linking alterations in
GABAA receptor function to disruptions in neuronal
excitability in vitro and in vivo, and ultimately adverse outcome, are
also currently lacking for this class of compounds. In the absence of
such data, the key biological steps leading to the adverse outcome
(i.e., the mammalian mechanism of action) cannot be established and by
extension a common mechanism of toxicity cannot be established.
    For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

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. Although no increased
sensitivity was seen in developmental toxicity studies in rats and
rabbits, increased qualitative and/or quantitative sensitivity of rat
pups was seen in the reproductive toxicity study and in the
developmental neurotoxicity study. In the reproduction study, whole
body tremors, hind limb extension, and hind limb splay were seen in the
F1 and F2 pups while these clinical signs were
not seen in F0 parental animals at similar dose levels. In
addition, a greater incidence of decreased fertility was seen in the
F1 parental females than in the F0 females. In
the developmental neurotoxicity study, no maternal effect was seen at
the highest dose tested whereas dose-related decrease in open-field
motor activity was seen in the mid-dose in pups on postnatal day 17.
Body tremors, hind-limb extension, and auditory startle were also found
in the high dose pups.
    3. Conclusion. Based on currently available data, EPA is retaining
the 10X FQPA safety factor for chronic assessments and is using a 3X
FQPA safety factor for acute assessments. This decision is based on the
following findings:
    i. Completeness of the toxicity database. The toxicology database
used to assess prenatal and postnatal exposure to emamectin contains
all required studies with exception of an immunotoxicity study and a
subchronic inhalation toxicity study, which are data gaps.
    The Agency evaluated subchronic, chronic, carcinogenicity,
developmental and reproduction studies as well as acute and subchronic
neurotoxicity studies for any effects that might indicate that
emamectin induced changes in the organs generally associated with
immunological toxicity. In the studies evaluated, only the 14-week oral
toxicity study in dogs showed an increase in the incidence of thymus
atrophy at 1 mg/kg/day. In the 1-year feeding study in dogs, thymus
atrophy was not reported at similar dose levels tested. Currently, the
point of departure for risk assessment is 0.075 mg/kg/day, which is
more than 10 times less than the dose where thymus atrophy had been
reported. Therefore, since the acute and chronic RfD's are 0.00025 mg/
kg/day and 0.000075 mg/kg/day, respectively, the Agency does not
believe an immunotoxicity study will result in a lower point of
departure (POD) than that which is currently in use for overall risk
assessment. As such, a database uncertainty factor is not necessary to
account for the lack of an immunotoxicity study.
    In regards to the inhalation toxicity study, there are currently no
residential uses registered for emamectin benzoate, and therefore, lack
of this study does

not impact the Agency's assessment of prenatal and postnatal exposure.
    Another completeness issue with regard to the toxicity database is
that EPA is using a short-term study for long-term risk assessment. The
data submitted show that CF-1 mice, which lack glycoprotein, are the
most sensitive species/strand of animal tested. EPA only has data on
CF-1 mice in short-term studies. Longer-term studies used CD-1 mice.
Hence a short-term study in CF-1 mice was used to choose the chronic
Point of Departure. The extrapolation from a short-term study in CF-1
mice to a long-term POD introduces additional uncertainty into the risk
assessment process.
    ii. Potential prenatal and postnatal toxicity. Although no
increased sensitivity was seen in developmental toxicity studies in
rats and rabbits, increased qualitative and/or quantitative sensitivity
of rat pups was seen in the reproductive toxicity study and in the
developmental neurotoxicity study. A degree-of-concern analysis was
conducted to determine whether or not an additional safety factor is
needed to account for the increased susceptibility in pups; it was
concluded that the degree-of-concern was low for both 2-generation
reproduction and developmental neurotoxicity studies. The reasons are
as follows:
    For the 2-generation reproduction study, (1) there was a clear
NOAEL for the offspring toxicity, and (2) the decreased fertility seen
in F1 adults might have been due to histopathological
lesions in the brain and central nervous system (seen in both
F0 and F1 generations), rather than due to a
direct effect on the reproductive system.
    For the developmental neurotoxicity study, (1) although multiple
offspring effects (including decreased pup body weight, head and body
tremors, hindlimb extension and splay, changes in motor activity and
auditory startle) were seen at the highest dose, and no maternal
effects were seen at any dose, there was a clear NOAEL for offspring
toxicity at the low dose, and (2) the offspring LOAEL (at the mid dose)
is based on a single effect seen on only one day (decreased motor
activity on postnatal day 17) and no other offspring toxicity was seen
at the LOAEL.
    Two other considerations raise residual concerns about whether the
traditional safety factors are protective of potential prenatal and
postnatal toxicity. First, the steepness of the dose-response curve
means that there is a small margin of error provided by reliance on the
study NOAEL. Second, the severity of effects at the LOAEL (death and
neuropathology), exacerbate the concern raised by the steep dose
response curve.
    iii. The completeness of the exposure database. The assessment for
food incorporates somewhat refined anticipated residue estimates for
most commodities that were derived from field trial data and PCT. The
availability and use of monitoring data and food preparation-reduction
factors for washing, cooking, etc. may have resulted in a more refined
estimate of dietary exposure. Therefore, exposures to residues in food
are not expected to be exceeded.
    The dietary drinking water assessment utilizes water concentration
values generated by model and associated modeling parameters which are
designed to provide conservative, health protective, high-end estimates
of water concentrations which will not likely be exceeded.
    Taking all of these findings into account, EPA has concluded that
there are not reliable data supporting lowering of the default 10X FQPA
safety factor for chronic exposures. Specifically, EPA does not have
reliable data showing that infants and children will be adequately
protected using the traditional inter- and intra-species safety factors
due to the steepness of the dose-response curve, the severity of
effects at the LOAEL (death and neuropathology), and the use of a
short-term study for long-term risk assessment. The Agency did not use
a chronic study for the POD because the chronic studies were conducted
in rats, dogs, and CD-1 mice.
    Taking all of these findings into account, for acute exposures, EPA
has concluded that there are reliable data supporting lowering the
default 10X FQPA safety factor to 3X. Although the steepness of the
dose-response curve and the severity of the effects at the LOAEL
introduce uncertainty with regard to whether the inter- and intra-
species safety factors are protective of infants and children from
acute effects, EPA has concluded that use of the 15-day neurotoxicity
CF-1 mouse study provides reliable data to reduce the FQPA safety
factor for acute assessments from 10X to 3X. The Agency determined that
a 3X FQPA Safety Factor is adequate for assessing acute dietary risk
based on the following weight of evidence considerations:
     An endpoint of concern attributable to a single exposure
was not identified for in utero effects since there was no concern for
developmental toxicity and there was no indication of increased
susceptibility (qualitative or quantitative) of rat or rabbit fetuses
to in utero exposure to emamectin;
     Although there was evidence of increased susceptibility in
the DNT study, an endpoint of concern was not identified for acute
dietary risk assessment for prenatal exposures because the adverse
effect at the LOAEL (i.e., decrease in open field motor activity) was
seen only on postnatal day 17 and not seen after a single exposure;
     The POD selected for acute dietary risk assessment is a
NOAEL (with a clear LOAEL) seen after repeated dosing but is used for
assessing acute risk (i.e., a very conservative approach).
    Therefore, the Agency is confident that the retention of a 3X FQPA
Safety Factor (to account for the steepness of the dose response curve)
will not underestimate risk and provides reasonable certainty of no
harm from exposure to emamectin benzoate.

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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and
drinking water to emamectin benzoate will occupy 60% of the aPAD for
children 1-2 years old, the population group receiving the greatest
exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
emamectin benzoate from food and water will utilize 16% of the cPAD for
all infants less than 1 year old, the population group receiving the
greatest exposure. There are no residential uses for emamectin
benzoate.
    3. Short-term risk. Short- and intermediate-term aggregate exposure
takes into account short- and intermediate-term residential exposure
plus chronic exposure to food and water (considered to be a background
exposure level).
    Both short- and intermediate-term adverse effects were identified;
however, emamectin benzoate is not registered for any use patterns that
would result in either short- or intermediate-term residential
exposure.

Short- and intermediate-term risk is assessed based on short- and
intermediate-term residential exposure plus chronic dietary exposure.
Because there is no short- 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- or intermediate-term risk), no further
assessment of short- or intermediate-term risk is necessary, and EPA
relies on the chronic dietary risk assessment for evaluating short- and
intermediate-term risk for emamectin benzoate.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, emamectin benzoate 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 emamectin benzoate residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high performance liquid
chromatography with fluorescence detection (HPLC/FLD)) 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>; email 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 United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for emamectin benzoate on
cucurbits.

C. Revisions to Petitioned-For Tolerances

    Based on the review of the residue data submitted with the
petition, the proposed tolerance level of 0.03 ppm is being modified to
0.02 ppm.
    Also, 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 emamectin benzoate 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, a tolerance is established for residues of emamectin,
including its metabolites and degradates, in or on the cucurbit
vegetable group 9 at 0.02 ppm. Compliance with the tolerance levels
specified is to be determined by measuring only the sum of emamectin (a
mixture of a minimum of 90% 4'-epi-methylamino-4'-deoxyavermectin
B1a and maximum of 10% 4'-epi-methylamino-4'-deoxyavermectin
B1b) and its metabolites 8,9-isomer of the B1a
and B1b component of the parent (8,9-ZMA), or 4'-deoxy-4'-
epi-amino-avermectin B1a and 4'-deoxy-4'-epi-amino-
avermectin B1b; 4'-deoxy-4'-epi-amino avermectin
B1a (AB1a); 4'-deoxy-4'-epi-(N-formyl-N-
methyl)amino-avermectin (MFB1a); and 4'-deoxy-4'-epi-(N-
formyl)amino-avermectin B1a (FAB1a), calculated
as the stoichiometric equivalent of emamectin.

VI. References

    The following literature was referenced in the preamble of this
document.

1. OPP's ``Guidance for Identifying Pesticide Chemicals and Other
Substances that have a Common Mechanism of Toxicity'' (USEPA, 1999);
http://www.epa.gov/fedrgstr/EPA-PEST/1999/February/Day-05/6055.pdf.
2. balis IM, Eldefrawi AT, Eldefrawi ME. Actions of avermectin
B1a on the gamma-aminobutyric acidA receptor and chloride
channels in rat brain. Journal of Biochemical Toxicology. 1986
Mar;1(1):69-82.
3. Huang J, Casida JE. (1997) Avermectin B1a binds to
high- and low-affinity sites with dual effects on the gama-
aminobutyric acid-gated chloride channel of cultured cerebellar
granule neurons. Journal of Pharmacology and Experimental
Therapeutics. 281: 261-266.
4. Dawson GR, Wafford KA, Smith A, Marshall GR, Bayley PJ, Schaeffer
JM, Meinke PT, McKernan RM. (2000) Anticonvulsant and adverse
effects of avermectin analogs in mice are mediated through the gama-
aminobutyric acid (A) receptor. Journal of Pharmacology and
Experimental Therapeutics 295: 1051-1060.
5. Soderlund DM, Adams PM, Bloomquist JR. Differences in the action
of avermectin B1a on the GABAA receptor
complex of mouse and rat. Biochemical Biophysical Research
Communications. 1987 Jul 31;146(2):692-8.

VII. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d)
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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (2 U.S.C.
1501 et seq.).
    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) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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
the rule in the Federal Register. This action 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: March 19, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Sec.  180.505, is amended by:
0
i. Revise paragraph (a)(1) introductory text and paragraph (a)(2)
introductory text;
0
ii. Add alphabetically an entry for ``Vegetable, cucurbit, group 9'' to
the table in paragraph (a)(1).
    The added and revised text read as follows:

Sec.  180.505  Emamectin; tolerances for residues.

    (a) General. (1) Tolerances are established for emamectin,
including its metabolites and degradates, in or on the commodities in
the table below. Compliance with the tolerance levels specified below
is to be determined by measuring only the sum of emamectin (a mixture
of a minimum of 90% 4'-epi-methylamino-4'-deoxyavermectin
B1a and maximum of 10% 4'-epi-methylamino-4'-deoxyavermectin
B1b) and its metabolites 8,9-isomer of the B1a
and B1b component of the parent (8,9-ZMA), or 4'-deoxy-4'-
epi-amino-avermectin B1a and 4'-deoxy-4'-epi-amino-
avermectin B1b; 4'-deoxy-4'-epi-amino avermectin
B1a (AB1a); 4'-deoxy-4'-epi-(N-formyl-N-
methyl)amino-avermectin (MFB1a); and 4'-deoxy-4'-epi-(N-
formyl)amino-avermectin B1a (FAB1a), calculated
as the stoichiometric equivalent of emamectin.

------------------------------------------------------------------------
                                                            Parts per
                       Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Vegetable, cucurbit, group 9...........................            0.02

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

     (2) Tolerances are established for emamectin, including its
metabolites and degradates, in or on the commodities in the table
below. Compliance with the tolerance levels specified below is to be
determined by measuring only the sum of emamectin (MAB1a +
MAB1b isomers) and the associated 8,9-Z isomers (8,9-
1a and 8,9-ZB1b).
* * * * *
[FR Doc. 2013-06758 Filed 3-26-13; 8:45 am]
BILLING CODE 6560-50-P