[Federal Register Volume 85, Number 29 (Wednesday, February 12, 2020)]
[Notices]
[Pages 7990-7991]
[FR Doc No: 2020-02812]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 6689-017]

Briar Hydro Associates, LLC; Notice of Intent To File License
Application, Filing of Pre-Application Document, and Approving Use of
the Traditional Licensing Process

    a. Type of Filing: Notice of Intent to File License Application and
Request to Use the Traditional Licensing Process.
    b. Project No.: 6689-017.
    c. Date Filed: November 29, 2019.
    d. Submitted By: Briar Hydro Associates, LLC (Briar Hydro).
    e. Name of Project: Rolfe Canal Hydroelectric Project.
    f. Location: On the Contoocook River, in the Village of Penacook
and City of Concord, New Hampshire. No federal lands are occupied by
the project works or located within the project boundary.
    g. Filed Pursuant to: 18 CFR5.3 and 5.5 of the Commission's
regulations.
    h. Potential Applicant Contact: Andrew J. Locke, Essex Hydro
Associates, LLC, 55 Union Street, Boston, MA 02108;<PHONE_NUMBER>;
[email protected]
    i. FERC Contact: Jeanne Edwards at<PHONE_NUMBER>; or email at
<EMAIL_ADDRESS>    j. Briar Hydro filed its request to use the Traditional Licensing
Process on November 29, 2019. Briar Hydro provided public notice of its
request on December 12, 2019. In a letter dated February 6, 2020, the
Director of the Division of Hydropower Licensing approved Briar Hydro's
request to use the Traditional Licensing Process.

    k. With this notice, we are initiating informal consultation with
the U.S. Fish and Wildlife Service and/or NOAA Fisheries under section
7 of the Endangered Species Act and the joint agency regulations
thereunder at 50 CFR, Part 402. We are also initiating consultation
with the New Hampshire State Historic Preservation Officer, as required
by section 106 of the National Historic Preservation Act, and the
implementing regulations of the Advisory Council on Historic
Preservation at 36 CFR 800.2.
    l. With this notice, we are designating Briar Hydro as the
Commission's non-federal representative for carrying out informal
consultation pursuant to section 7 of the Endangered Species Act and
consultation pursuant to section 106 of the National Historic
Preservation Act.
    m. On November 28, 2019, Briar Hydro filed a Pre-Application
Document (PAD; including a proposed process plan and schedule) with the
Commission, pursuant to 18 CFR 5.6 of the Commission's regulations.
    n. A copy of the PAD is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's website
(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, contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). A copy is also available for inspection and reproduction at
the address in paragraph h.
    o. The licensee states its unequivocal intent to submit an
application for a new license for Project No. 6689. Pursuant to 18 CFR
16.8, 16.9, and 16.10 each application for a new license and any
competing license applications must be filed with the Commission at
least 24 months prior to the expiration of the existing license. All
applications for license for this project must be filed by November 30,
2022.
    p. Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.

    Dated: February 6, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-02812 Filed 2-11-20; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 171 (Thursday, September 4, 2014)]
[Notices]
[Pages 52794-52797]
[FR Doc No: 2014-20997]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72941; File No. SR-ICC-2014-14]

Self-Regulatory Organizations; ICE Clear Credit LLC; Notice of
Filing of Proposed Rule Change to Add Rules Related to the Clearing of
Standard Western European Sovereign CDS Contracts

August 28, 2014.
    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 August 25, 2014, ICE Clear Credit LLC (``ICC'') 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 primarily by ICC. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The purpose of the proposed rule change is to adopt new rules that
will provide the basis for ICC to clear additional credit default swap
contracts. Specifically, ICC is proposing to amend Chapter 26 of its
rules to add Subchapter 26I and to amend the ICC Risk Management
Framework to provide for the clearance of Standard Western European
Sovereign CDS contracts, specifically the Republic of Ireland, the
Italian Republic, the Portuguese Republic, and the Kingdom of Spain
(collectively, the ``SWES Contracts''). The proposed change is
dependent on the approval and implementation of the proposed rule
change contained in ICC-2014-11 and therefore, the text of the proposed
rule change in Exhibit 5 should be read in conjunction with the text of
the proposed rule change in Exhibit 5 to ICC-2014-11.\3\
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    \3\ See Securities Exchange Act Release No. 34-72701 (Jul. 29,
2014), 79 FR 45565 (Aug. 5, 2014) (SR-ICC-2014-11). The text of the
proposed rule change for rule filing SR-ICC-2014-11 can also be
found on ICC's Web site at https://www.theice.com/clear-credit/regulation.
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II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, ICC 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. ICC has prepared summaries, set forth in sections A, B,
and C below, of the most significant aspects of these statements.

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

1. Purpose
    ICC has identified SWES Contracts as products that have become
increasingly important for market participants to utilize for risk
management. ICC believes that clearance of SWES Contracts will
facilitate the prompt and accurate clearance and settlement of
securities transactions and derivative agreements, contracts, and
transactions for which it is responsible.
    SWES Contracts have similar terms to the Standard North American
Corporate Single Name CDS contracts (``SNAC Contracts'') currently
cleared by ICC and governed by Subchapter 26B of the ICC Rules, the
Standard Emerging Sovereign CDS contracts (``SES Contracts'') currently
cleared by ICC and governed by Subchapter 26D of the ICC Rules, and the
Standard European Corporate Single

Name CDS contracts (``SDEC Contracts'') currently cleared at ICC and
governed by Subchapter 26G of the ICC Rules. Accordingly, the proposed
rules found in Subchapter 26I largely mirror the ICC Rules for SNAC
Contracts in Subchapter 26B, SES Contracts in Subchapter 26D, and SDEC
Contracts in Subchapter 26G, with certain modifications that reflect
differences in terms and market conventions between those contracts and
SWES Contracts. SWES Contracts will be denominated in United States
Dollars.
    The proposed rules set forth in Subchapter 26I incorporate
references to revised Credit Derivatives Definitions, as published by
the International Swaps and Derivatives Association, Inc. (``ISDA'') on
February 21, 2014 (the ``2014 ISDA Definitions''). ICC has a rule
filing currently pending with the Commission consisting of proposed
amendments to the ICC Rules to incorporate references to the 2014 ISDA
Definitions (ICC-2014-11).\4\ This filing has a planned effective date,
consistent with the industry implementation date of the 2014 ISDA
Definitions, on September 22, 2014. The 2014 ISDA Definitions will be
applicable to SWES Contracts cleared by ICC, and, as such, references
to the 2014 ISDA Definitions are utilized throughout the SWES
Contracts-related rules found in Subchapter 26I. Thus, approval and
implementation of clearing SWES Contracts is dependent on the approval
and implementation of the proposed rule change contained in ICC-2014-11
and therefore, the text of the proposed rule change in Exhibit 5 should
be read in conjunction with the text of the proposed rule change in
Exhibit 5 to ICC-2014-11.\5\ ICC will not implement the 2014 ISDA
Definitions-related rule changes until regulatory approval is received
and until the industry implementation date of September 22, 2014.
Similarly, ICC will not begin clearing SWES Contracts until the later
of receipt of regulatory approval or the industry implementation date
of September 22, 2014. SWES Contracts will only be offered on the 2014
ISDA Definitions.
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    \4\ Id.
    \5\ Id.
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    Rule 26I-102 (Definitions) sets forth the definitions used for the
SWES Contracts. An ``Eligible SWES Reference Entity'' is defined as
``each particular Reference Entity included in the List of Eligible
SWES Reference Entities,'' which is a list maintained, updated and
published from time to time by ICC containing certain specified
information with respect to each reference entity. If ICC determines to
add or remove additional SWES Contracts from the List of Eligible SWES
Reference Entities, it will seek approval from the Commission for such
contracts (or for a class of product including such contracts) by a
subsequent filing. The remaining definitions are substantially the same
as the definitions found in Subchapters 26B, 26D, and 26G of the ICC
Rules, other than certain conforming changes.
    ICC Rules 26I-203 (Restriction on Activity), 26I-206 (Notices
Required of Participants with respect to SWES Contracts), 26I-303 (SWES
Contract Adjustments), 26I-309 (Acceptance of SWES Contracts by ICE
Clear Credit), 26I-315 (Terms of the Cleared SWES Contract), 26I-316
(Relevant Physical Settlement Matrix Updates), 26I-502 (Specified
Actions), and 26I-616 (Contract Modification) reflect or incorporate
the basic contract specifications for SWES Contracts and are
substantially the same as under Subchapters 26B, 26D, and 26G of the
ICC Rulebook.
    Clearing SWES Contracts will not require any changes to ICC's
operational procedures, as the SWES Contracts operate similarly to the
Standard Emerging European and Middle Eastern Sovereign Single Names,
currently cleared by ICC. The addition of SWES Contracts to ICC's
product offering requires risk specific changes to the ICC Risk
Management Framework, which are described below.
    ICC's Risk Management Framework has been revised to incorporate
additional model features designed to generalize the currently
established Specific Wrong Way Risk (``SWWR'') Initial Margin (``IM'')
requirement. The proposed changes to the ICC Risk Management Framework
generalize the SWWR relative to General Wrong Way Risk (``GWWR''). This
generalization of Wrong Way Risk (``WWR'') is introduced to account for
additional risk present in CDS instruments whose reference entities
exhibit a high level of correlation with those Clearing Participants
clearing the relevant name, or with an entity that is guaranteed by, or
affiliated with, those Clearing Participants. To this effect, the
offering of SWES Contracts introduces potential GWWR in the form of
country/region of domicile WWR. Examples of GWWR related to SWES
include but are not limited to a CP selling protection on its country
of domicile, or a European domiciled Clearing Participant selling
protection on European sovereign reference entities. To address such
risks, an additional Jump To Default Risk (``JTDR'') requirement is
established.
    Accordingly, the Risk Management Framework contains revisions to
the calculation of the portfolio JTDR requirement. Specifically, the
calculations have been updated to incorporate the concept of WWR as
described below in reference to the quantitative and qualitative
approaches. These revisions will have no material impact on the size of
the Guaranty Fund.
    ICC's proposed changes adopt a combination of qualitative and
quantitative approaches to capture GWWR. Under the revised ICC Risk
Management Framework, an additional contribution to the JTDR
requirement will be required when Clearing Participants sell protection
on SWES reference entities exhibiting a high degree of association with
itself (quantitative approach) or by virtue of selling protection on
its country of domicile (qualitative approach). For the qualitative
case, ICC will require full collateralization of the additional Jump To
Default (``JTD'') loss. In determining a Clearing Participants' country
of domicile for purposes of the qualitative determination, ICC refers
to the International Organization for Standardization (``ISO'') country
code for the issuer's ultimate parent country of risk. The ISO
methodology considers management location, country of primary listing,
country of revenue and reporting currency of the issuer.
    The quantitative approach applies to the additional risk arising
from Clearing Participants selling protection on SWES reference
entities, other than the Clearing Participant's country of domicile, on
which the Clearing Participant's domicile has a high degree of
correlation. If the additional SWES JTD losses and the dependence
levels breach specific threshold amounts, additional GWWR
collateralization will be required. The additional collateralization is
a function of the level of correlation between the Clearing
Participants and the SWES reference entities and will become more
conservative as the level of correlation increases.
    As a result of these enhancements to the ICC Risk Management
Framework, Rule 26D-309 (Acceptance of SES Contracts by ICE Clear
Credit), part (c) has been revised to remove language which prohibits
the acceptance of Trades for clearance and settlement if at the time of
submission or acceptance of the Trade or at the time of novation the
Participant submitting the Trade is domiciled in the country of the
Eligible Standard Emerging Sovereign (``SES'') Reference Entity for
such SES contract. The new GWWR methodology will

apply to all sovereign contracts cleared by ICC, including SES
contracts.
2. Statutory Basis
    Section 17A(b)(3)(F) of the Act \6\ requires, among other things,
that the rules of a clearing agency be designed to promote the prompt
and accurate clearance and settlement of securities transactions and,
to the extent applicable, derivative agreements, contracts, and
transactions and to comply with the provisions of the Act and the rules
and regulations thereunder. These contracts are similar to the SNAC,
SES, and SDEC Contracts currently cleared by ICC, and the SWES
Contracts will be cleared pursuant to ICC's existing clearing
arrangements and related financial safeguards, protections and risk
management procedures, except as described herein. The addition of SWES
Contracts will allow market participants an increased ability to manage
risk. ICC believes that acceptance of the new contracts, on the terms
and conditions set out in the ICC Rules, is consistent with the prompt
and accurate clearance of and settlement of securities transactions and
derivative agreements, contracts and transactions cleared by ICC, the
safeguarding of securities and funds in the custody or control of ICC,
and the protection of investors and the public interest, within the
meaning of Section 17A(b)(3)(F) of the Act.\7\ ICC performed a
comprehensive risk analysis related to the clearing of SWES Contracts
and identified the introduction of GWWR as a new risk and accommodated
for this risk in the ICC Risk Management Framework, as discussed
herein. ICC identified no additional risk or systemic risk concerns
introduced by clearing SWES Contracts, not accounted for by ICC's
existing risk management procedures. As such, clearing the new SWES
Contracts is consistent with the requirement of promoting and
protecting the public interest in Section 17A(b)(3)(F).\8\
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    \6\ 15 U.S.C. 78q-1(b)(3)(F).
    \7\ Id.
    \8\ Id.
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    Clearing of the additional SWES Contracts will also satisfy the
requirements of Rule 17Ad-22.\9\ In particular, in terms of financial
resources, ICC will apply its existing margin methodology to the
additional contracts, with enhancements to address General Wrong Way
Risk discussed above. ICC believes that this model will provide
sufficient margin to cover its credit exposure to its clearing members
from clearing such contracts, consistent with the requirements of Rule
17Ad-22(b)(2).\10\ In addition, ICC believes its Guaranty Fund, under
its existing methodology, will, together with the required margin,
provide sufficient financial resources to support the clearing of the
additional contracts consistent with the requirements of Rule 17Ad-
22(b)(3).\11\ ICC also believes that its existing operational and
managerial resources will be sufficient for clearing of the additional
contracts, consistent with the requirements of Rule 17Ad-22(d)(4),\12\
as the new contracts are substantially the same from an operational
perspective as existing contracts. Similarly, ICC will use its existing
settlement procedures and account structures for the new contracts,
consistent with the requirements of Rule 17Ad-22(d)(5), (12) and (15)
\13\ as to the finality and accuracy of its daily settlement process
and avoidance of the risk to ICC of settlement failures. ICC determined
to accept the SWES contracts for clearing in accordance with its
governance process, which included review of the contracts and related
risk management considerations (and the enhancements to the margin
methodology for General Wrong Way Risk discussed herein) by the ICC
Risk Committee and approval by its Board. These governance arrangements
are consistent with the requirements of Rule 17Ad-22(d)(8).\14\
Finally, ICC will apply its existing default management policies and
procedures for the SWES contracts. ICC believes that these procedures
allow for it to take timely action to contain losses and liquidity
pressures and to continue meeting its obligations in the event of
clearing member insolvencies or defaults in respect of the additional
single names, in accordance with Rule 17Ad-22(d)(11).\15\
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    \9\ 17 CFR 240.17Ad-22.
    \10\ 17 CFR 240.17Ad-22(b)(2).
    \11\ 17 CFR 240.17Ad-22(b)(3).
    \12\ 17 CFR 240.17Ad-22(d)(4).
    \13\ 17 CFR 240.17Ad-22(d)(5), (12) and (15).
    \14\ 17 CFR 240.17Ad-22(d)(8).
    \15\ 17 CFR 240.17Ad-22(d)(11).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    ICC does not believe the proposed rule change would have any
impact, or impose any burden, on competition. The proposed GWWR
methodology and the additional JTDR will apply uniformly to all ICC
Clearing Participants, as applicable. The SWES Contracts will be
available for clearing to all ICC Clearing Participants. The clearing
of SWES Contracts by ICC does not preclude the offering of this product
for clearing by other market participants. Therefore, ICC does not
believe the proposed rule change imposes any burden on competition that
is inappropriate in furtherance of the purposes of the Act.

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

    Written comments relating to the proposed rule change have not been
solicited or received. ICC will notify the Commission of any written
comments received by ICC.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove the proposed rule change or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml) or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-ICC-2014-14 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-ICC-2014-14. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the

Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for Web site viewing and printing in
the Commission's Public Reference Room, 100 F Street NE., Washington,
DC 20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filings also will be available for inspection
and copying at the principal office of ICE Clear Credit and on ICE
Clear Credit's Web site at https://www.theice.com/clear-credit/regulation.
    All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-ICC-2014-14
and should be submitted on or before September 25, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
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    \16\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-20997 Filed 9-3-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 89 (Tuesday, May 11, 2021)]
[Notices]
[Pages 25905-25906]
[FR Doc No: 2021-09887]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-91779; File No. SR-NYSEAMER-2021-05]

Self-Regulatory Organizations; NYSE American, LLC.; Order
Granting Approval of a Proposed Rule Change, as Modified by Amendment
No. 1, To Amend Rule 970NY and Rule 970.1NY To Eliminate the Use of
Dark Series on the Exchange

May 5, 2021.

I. Introduction

    On January 26, 2021, NYSE American, LLC (``NYSE American'' or the
``Exchange'') 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 amend Rule 970NY (``Firm Quotes'') and Rule
970.1NY (``Quote Mitigation'') to eliminate the use of ``dark'' series
on the Exchange. The proposed rule change was published for comment in
the Federal Register on February 8, 2021.\3\ On March 18, 2021,
pursuant to Section 19(b)(2) of the Act,\4\ the Commission designated a
longer period within which to approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether to approve or disapprove the proposed rule change.\5\
On April 27, 2021, the Exchange filed Amendment No. 1 to the proposed
rule change.\6\ The Commission received no comment letters on the
proposal. This order approves the proposed rule change, as modified by
Amendment No. 1.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 91039 (February 2,
2021), 86 FR 8659 (``Notice'').
    \4\ 15 U.S.C. 78s(b)(2).
    \5\ See Securities Exchange Act Release No. 91355, 86 FR 15733
(March 24, 2021). The Commission designated May 9, 2021, as the date
by which it should approve, disapprove, or institute proceedings to
determine whether to approve or disapprove the proposed rule change.
    \6\ In Amendment No. 1, the Exchange provided data that showed
that during the eighteen (18) trading days between March 1, 2021 and
March 24, 2021, quotes in dark series accounted for 2.43% of NYSE
Arca, Inc. (``NYSE Arca'') quotes and 1.99% of NYSE American quotes,
and quotes in dark series averaged 0.174% on NYSE Arca and 0.190% on
NYSE American when compared to the total OPRA disseminated quotes
during the same period. The Exchange also stated that on March 4,
2021 and March 5, 2021, OPRA processed the most messages in its
history and provided data that shows that on March 4th, quotes in
dark series from NYSE Arca and NYSE American combined for 0.5095%
compared to OPRA message traffic. On March 5th, quotes in dark
series from NYSE Arca and NYSE American combined for 0.2562% when
compared to OPRA quote volume. The Exchange concluded that
eliminating the suppression of quotes in dark series would result in
a de minimis increase in quotes sent by NYSE Arca and NYSE American
to OPRA and have essentially no impact on messaging at an industry
level. Because Amendment No. 1 to the proposed rule change does not
materially alter the substance of the proposed rule change,
Amendment No. 1 is not subject to notice and comment. Amendment No.
1 is available on the Commission's website at: https://www.sec.gov/comments/sr-nyseamer-2021-05/srnyseamer202105-8730999-237044.pdf.
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II. Description of the Proposed Rule Change, as Modified by Amendment
No. 1

    Currently, NYSE American Rule 970NY (``Firm Quotes'') requires the
Exchange to collect, process, and make available to quotation vendors
the best bid and best offer for each option series that is a reported
security unless the series is subject to an approved quote mitigation
plan.\7\ Pursuant to the quote mitigation plan set forth in NYSE
American Rule 970.1NY, the Exchange only disseminates quotes in
``active'' series.\8\ A series is considered active if the series: (i)
Has traded on any options exchange in the previous 14 calendar days;
(ii) is solely listed on the Exchange; (iii) has been trading ten days
or less; or (iv) is a series in which the Exchange has an order.\9\ In
addition, a series may be considered active on an intraday basis if:
(i) The series trades at any options exchange; (ii) the Exchange
receives an order in the series; or (iii) the Exchange receives a
request for quote from a customer in that series.\10\ Any options
series that does not meet the definition of an active series is deemed
be an inactive or ``dark'' series. Consequently, under the Exchange's
current rules, although the Exchange accepts quotes from ATP Holders in
all series, the only quote messages the Exchange disseminates to the
Options Price Reporting Authority (``OPRA'') are quotes for active
series.\11\ The Exchange proposes to delete NYSE American Rule 970.1NY.
Therefore, the proposed rule change would eliminate the distinction
between active and dark series, and thus require quotes in all series
to be disseminated to OPRA.\12\
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    \7\ See NYSE American Rule 970NY(b)(1).
    \8\ The quote mitigation plan set forth in NYSE American Rule
970.1NY was adopted in conformance with NYSE Arca's similar quote
mitigation rule, which was adopted in connection with the Penny
Pilot Program, a program which was subsequently approved on a
permanent basis in 2020. See Notice, supra note 3, at 8659.
    \9\ See NYSE American Rule 970.1NY.
    \10\ See NYSE American Rule 970.1NY.
    \11\ See Notice, supra note 3, at 8659. See also Amendment No.
1, supra note 6 (providing data to support the Exchange's conclusion
that eliminating the suppression of quotes in dark series would
result in a de minimis increase in quotes sent by NYSE Arca and NYSE
American to OPRA and would have essentially no impact on messaging
at an industry level).
    \12\ See Notice, supra note 3, at 8659.
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III. Discussion and Commission Findings

    The Commission finds that the proposed rule change, as modified by
Amendment No.1, is consistent with the requirements of the Act and the
rules and regulations thereunder applicable to a national securities
exchange.\13\ In particular, the Commission finds that the proposed
rule change, as modified by Amendment No. 1, is consistent with Section
6(b)(5) of the Act,\14\ which requires that the rules of an exchange be
designed, among other things, to prevent fraudulent and manipulative
acts and practices, to promote just and equitable principles of trade,
to foster cooperation and coordination with persons engaged in
regulating and facilitating transactions in securities, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system and, in general, to protect investors and the
public interest.
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    \13\ In approving this proposed rule change, as modified by
Amendment No.1, the Commission has considered the proposed rule's
impact on efficiency, competition, and capital formation. See 15
U.S.C. 78c(f).
    \14\ 15 U.S.C. 78f(b)(5).
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    In support of its proposal, the Exchange states the proposed rule
change would increase transparency, enhance price discovery, and
alleviate potential confusion among market participants regarding what
quotes are being published in the disseminated quote feed and what
quotes are being suppressed.\15\ According to the

Exchange, discontinuing the use of the quote mitigation plan set forth
in NYSE American 970.1NY would result in all Market Maker quotes
(including those currently being suppressed because they are considered
inactive) being displayed and reflected in the market, benefitting
market participants by providing notice of such liquidity and removing
the element of potential confusion.\16\
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    \15\ See Notice, supra note 3, at 8660 (stating that ``over the
years, certain market participants have expressed confusion
regarding what quotes are being published and which are being
suppressed'').
    \16\ See Notice, supra note 3, at 8660.
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    Further, the Exchange states the proposed rule change would not
change the amount of capacity needed at OPRA to accommodate the
inclusion of quotes in dark series because the Exchange already
includes such quotes in the Exchange's current capacity planning
requests to OPRA.\17\ According to the Exchange, the proposal would not
impact market participants or downstream users that consume Exchange or
OPRA data because the quote capacity information OPRA currently
publishes already reflects quotes in dark series because they are part
of the Exchange's current capacity request.\18\ Thus, according to the
Exchange, market participants (including data vendors and subscribers)
currently have the opportunity to prepare for and make necessary
accommodations for anticipated quote traffic (including quotes in dark
series).\19\ Further, the Exchange anticipates that the proposed
increase in quote message traffic due to the dissemination of quotes in
inactive series is likely to be minimal and therefore unlikely to
impact the flow of message traffic and/or harm downstream consumers of
OPRA data.\20\ In support of this assertion, the Exchange states that
on the two trading days that OPRA processed the most messages in its
history (March 4, 2021 and March 5, 2021), quotes in dark series from
NYSE Arca and NYSE American combined were only 0.5095% and 0.2562%,
respectively, compared to OPRA message traffic.\21\ Finally, the
Exchange states its additional existing quote mitigation strategies are
sufficient to continue to mitigate quote traffic.\22\
---------------------------------------------------------------------------

    \17\ See Notice, supra note 3, at 8660. The Exchange represents
that it has always factored the total quote traffic it receives from
Market Makers, including quotes in dark series, when making its
capacity requests to OPRA. Specifically, the Exchange ``presumes
that all series will be active and therefore requests capacity to
accommodate sending quotes in all series to OPRA.'' Id.
    \18\ See Notice, supra note 3, at 8660.
    \19\ See id.
    \20\ See id. at 8661. See also Amendment No.1, supra note 6.
    \21\ See Amendment No.1, supra note 6.
    \22\ See Notice, supra note 3, at 8660 (discussing three quote
mitigation strategies the exchange currently employs to reduce the
potential for excessive quoting and to reduce quote traffic).
---------------------------------------------------------------------------

    The Commission believes that eliminating the exclusion of inactive
or dark series from the requirements of NYSE American Rule 970NY should
increase transparency and may enhance opportunities for price
discovery. Publishing all quotes (not just those in active series) in
the disseminated quote feed may benefit market participants because it
will provide notice of additional liquidity. Further, because the
Exchange currently includes Market Maker quotes in inactive series in
its capacity planning request to OPRA \23\ and because publication of
dark quotes from both the Exchange and NYSE Arca combined would result
in a percentage increase in OPRA disseminated quotes that is de minimis
according to the Exchange's data,\24\ the Commission believes that
dissemination of these quotes as part of the Exchange's quote feed to
OPRA is not likely to negatively impact systems capacity. In addition,
the Exchange has existing additional quote mitigation strategies that
also serve to reduce the potential for excessive quoting.\25\
---------------------------------------------------------------------------

    \23\ See id. at 8660.
    \24\ See Amendment No.1, supra note 6. In addition, the Exchange
states that there is sufficient capacity at OPRA to accommodate any
additional quote traffic that will result from the elimination of
dark series. See Notice, supra note 3, at 8660. The Exchange further
notes that it does not believe its proposal will impact any other
exchange's capacity at OPRA. See id. at 8660 n.8.
    \25\ See Notice, supra note 3, at 8660.
---------------------------------------------------------------------------

    Accordingly, for the reasons set forth above, the Commission finds
that the proposed rule change, as modified by Amendment No.1, is
consistent with Section 6(b)(5) of the Act \26\ and the rules and
regulations thereunder applicable to a national securities exchange.
---------------------------------------------------------------------------

    \26\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\27\ that the proposed rule change (SR-NYSEAMER-2021-05), as
modified by Amendment No. 1, hereby is approved.
---------------------------------------------------------------------------

    \27\ 15 U.S.C. 78s(b)(2).
    \28\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\28\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-09887 Filed 5-10-21; 8:45 am]
BILLING CODE 8011-01-P


Mr. Marco Gonzalez Executive Secretary Ozone Secretariat United Nations Environment Programme United Nations Avenue P.O. Box 30552 Nairobi, Kenya

Dear Mr. Gonzalez:

	Consistent with provisions of the Montreal Protocol and of Decision IX/6 of the Parties to the Montreal Protocol, the United States submits the enclosed nomination for a methyl bromide critical use exemption (CUE) in 2013.  This nomination is intended for consideration by the Parties to the Protocol at their Twenty Third meeting in 2011.  The enclosed document includes separate chapters that describe each of the sectors for which the United States is making a nomination.  We hope that this organization provides the information in the most accessible manner to facilitate the efforts of the Technology and Economic Assessment Panel and the Methyl Bromide Technical Options Committee during their review.

	The United States is making steady progress on reducing our CUE exemption and this year's nomination represents a reduction of more than 93% since our first approved exemption for 2005.  I also want to inform you and the MBTOC members that we are taking a further look at our Southeastern sectors of cucurbits, eggplant, peppers, and tomato to gather additional information.  We have made a substantial cut in these sectors because overall the alternatives available for use look promising in that region, although further time may be needed to fully transition.  We intend to submit additional information on these 4 Southeastern vegetable sectors no later than July 15 to further inform the MBTOC in their deliberations.

      We appreciate your consideration of this application, and look forward to working with you and others to answer any questions that may arise during the review process.   Best regards.                     						Sincerely,                            						John Thompson       						Deputy Director	       						Office of Environmental Policy


Comments about Study/Endpoint/Uncertainty Factors:  The selected endpoint provides the most sensitive NOAEL available from a study of appropriate duration and exposure (oral). Atrophy of the testes and prostate were observed in the dog subchronic oral toxicity study also at a dose of 60 mg/kg/day (NOAEL = 20 mg/kg/day).
Uncertainty Factor: 100X (10X interspecies extrapolation, 10X intraspecies variability).

A.3.5	Dermal Exposure (Short-, Intermediate- and Long-Term)
The repeated [21-day] dermal toxicity study was considered for these exposure scenarios because the route of exposure is appropriate. Although no effects were observed, the limit dose was tested, no clinical signs were observed, the target organs [liver and testes] were evaluated, and there is no reproductive toxicity concern. Since no hazard was identified, no risk from dermal exposure is expected.

A.3.6	Inhalation Exposure (Short -Term)
Study Selected: Chronic oral toxicity study - dog
MRID No.:  46378401
Executive Summary:  See Appendix A, Guideline [§ 870.3100]
Dose and Endpoint for Risk Assessment: NOAEL = 30 mg/kg/day based on clinical signs (ataxia, tremors, salivation, twitching) seen on day 1 of dosing in both sexes at LOAEL = 90 mg/kg/day.
Comments about Study/Endpoint/Uncertainty Factors: The study is appropriate for the short-term assessment since the signs of neurotoxicity were observed on the first day of dosing and throughout the first week of exposure. The dog is the most sensitive species for the neurotoxic effects observed, and neurotoxicity is the most sensitive endpoint in the toxicity database. The dose and endpoint are protective of effects observed in postnatal animals (population of concern) in the reproduction toxicity study (decreased pup body weight/gain).
Uncertainty Factor: 100X (10X interspecies extrapolation, 10X intraspecies variability).

A.3.7	Inhalation Exposure (Intermediate- and Long-Term)
Study Selected: Chronic oral toxicity study - dog
MRID No.:  46378401
Executive Summary:  See Appendix A, Guideline [§ 870.3100]
Dose and Endpoint for Risk Assessment: NOAEL = 10 mg/kg/day based on death and atrophy of the testes and prostate seen on at LOAEL = 30 mg/kg/day.
Comments about Study/Endpoint/Uncertainty Factors:  The selected endpoint provides the most sensitive NOAEL available from a study of appropriate duration and exposure (oral). Atrophy of the testes and prostate were observed in the dog subchronic oral toxicity study also at a dose of 60 mg/kg/day (NOAEL = 20 mg/kg/day).
Uncertainty Factor: 100X (10X interspecies extrapolation, 10X intraspecies variability).

A.4	Executive Summaries

A.4.1	Subchronic Toxicity

	870.3100	90-Day Oral Toxicity - Rat
In a subchronic oral toxicity study (MRID 44237704), metaldehyde (99.0% a.i.) was fed to 10 Sprague-Dawley CD rats/sex/dose at dietary concentrations of 0, 2,500, 5,000, 10,000, or 20,000 ppm (equivalent to approximately 0, 200, 400, 800, or 1550 mg/kg/day) for 28 consecutive days.  The study was to be used as a range-finding study for a chronic oncogenicity and a 2-generation study that were scheduled to be conducted.

Mortality, either as spontaneous death or moribund sacrifice, occurred in 6/10 10,000-ppm females and 10/10 20,000-ppm females, and in 4/10 20,000-ppm males.  In decedent animals, hind limb paralysis was the predominant effect observed prior to death, although tonic convulsions, excessive vocalization, gasping, and hyperactivity were also observed in one high-dose female.

Increases (10-28%) in blood urea nitrogen concentrations in all treated females were observed, with significance (p<0.05 or 0.01) at the 2,500- and 10,000-ppm levels.  Slight decreases (6-8%, p<0.05) in erythrocytes were observed in the 10,000-ppm males.

Treatment-related increases (p<0.01) in absolute (up to 67%) and relative (up to 69%) liver weights were observed in both sexes and all test groups.  Furthermore, histopathological examination revealed hepatocellular hypertrophy in both sexes at all test levels.

Findings upon gross necropsy were limited to animals that died or were sacrificed during the study and included fracture/luxation of the vertebra, hemorrhage of the spinal cord, abnormal coloration of various organs, hydronephrosis and/or hemorrhage of the kidneys, and dilatation/distention and/or hemorrhage of the urinary bladder.  The urinary tract abnormalities were presumably secondary to urine stasis resulting from paralysis.  Similarly, microscopic examination revealed luxation of the vertebra; hemorrhaging of the vertebra and spinal cord; spinal cord compression, vacuolization, and malacia; hydronephrosis; and general congestion and/or hemorrhaging of various organs, including the thymic region, lungs, kidneys, and urinary bladder.

The systemic LOAEL is 2,500 ppm (equivalent to approximately 200 mg/kg/day) based on increased absolute and relative liver weights in all dose groups and hepatocellular hypertrophy at all dose levels in both sexes.  The systemic NOAEL was not established.

This 28-day oral (dietary) study is classified acceptable (Non Guideline) as it is not a required guideline study.  It is acceptable for the purposes for which it was intended [range-finding study].

	870.3150	90-Day Oral Toxicity - Dog
In a 26-week oral toxicity study (MRID 00131432); beagle dogs were administered 0, 20, 60 or 90 mg/kg/day metaldehyde in the diet.  All animals survived the 26-week period and no clinical signs of toxicity were observed. No effects were observed for food consumption, body weight, drinking water intake, hematology, clinical chemistry, ophthalmology, or organ weights. Diffuse or focal atrophy of the prostate and testes were observed in the 60 and 90 mg/kg/day groups. There were increases in follicular hyperplasia of the mesenteric lymph node in the 90 mg/kg/day group. Animals in the 90 mg/kg/group had slight increases in periportal infiltration of lymphocytes, histiocytes and eosinophilic granulocytes in the liver and very slight hydropic swelling in focal areas of the liver, which are probably of no toxicological significance.

The NOEL/LEL were determined to be 20 mg/kg/day / 60 mg/kg/day, based on diffuse or focal atrophy of the testes and prostate.  The study is core-minimum and satisfies the requirements for a Guideline Series 83-1(b) chronic toxicity study in dogs.

	870.3200	21/28-Day Dermal Toxicity  -  Rat
In a 21-day dermal toxicity study (MRID 42063401), 5 New Zealand White rabbits/sex/group were administered metaldehyde  [99.0%] via dermal application [dry powder covered with a gauze patch moistened with Milli-Q(R) filtered water; once a day for 6 hours, 5 days/week] for 22 days at concentrations of 0, 100, 300, and 1000 mg/kg/day.

Treatment had no adverse effect on survival, clinical signs, mean body weight, body-weight gain, food consumption, hematology, clinical chemistry, organ weights, or gross and microscopic pathology. There was no dose-related increase in the incidence or severity of signs of dermal toxicity.

The NOAEL for systemic and dermal toxicity is 1000 mg/kg/day, the highest dose tested

This guideline 21-day dermal toxicity study is classified ACCEPTABLE, and it satisfies the guideline requirement [§82-2; 870.3200] for a 21-day dermal toxicity study. Although fewer rabbits/sex/group were utilized than specified in the Guideline, this does not by itself diminish the finding of no effect at the limit dose.

	870.3465	90-Day Inhalation  -  Rat

Study waived by HASPOC (TXR# 0056524, dated 2/21/13)

A.4.2	Prenatal Developmental Toxicity

	870.3700a Prenatal Developmental Toxicity Study - Rat
In a developmental toxicity study [MRID 41656001], female Sprague-Dawley Crl:CD(SD)BR rats [25/group] were administered metaldehyde [99%] via gavage at dose levels of 0 [Mazola(R) corn oil], 25 mg/kg/day, 75 mg/kg/day, and 150 mg/kg/day from gestation day 6 through gestation day 15.

There were six deaths [all pregnant; high-dose level only], which occurred between gestation days 7 and 8. Clinical signs attributed to treatment were observed at the high-dose level in those dams that died and included ataxia [all six], rapid respiration [5 dams], twitching [4 dams], tremors [3 dams], prostration [1 dam], abdominal breathing [1 dam], hyperactivity [1 dam], paresis of the hind legs [1 dam], pallor [2 dams], perioral encrustation [3 dams], and perinasal encrustation [2 dams]. Decreased body weight [96% of control] was observed at the high-dose level only on gestation day [GD] 9. Body-weight gain was significantly decreased [74% of control] initially [GD 6-9] and throughout the dosing period at the high-dose level.  Although dams at the mid-dose level displayed only a slightly lower body-weight gain during the dosing period [91% of control] compared to the control, based on their pre-dose body-weight gain [115% of control], the decrease is considered treatment-related. A compensatory weight gain was noted during the post-dosing period at the high-dose level. Corrected body-weight gain at the high-dose level was slightly [94% of control] lower than the control value. Food consumption was decreased at the high-dose level during the dosing period and increased significantly during the post-dosing period at the mid- and high-dose levels.

Treatment-related necropsy findings in the dams dying on test included thinning of the stomach wall [1 dam], ulceration of the glandular [2 dams] and nonglandular [2 dams] portion of the stomach, red/brown lungs [6 dams], dilated renal pelvis [2 dams], and hydronephrosis [1 dam]. Additionally, perioral encrustation [6 dams], perinasal encrustation [5 dams], and paravertebral hemorrhage [1 dam] were observed in those dying on test.  There were no adverse effects observed on maternal liver weight or gravid uterine weight.

There were no abortions, and the pregnancy rate was comparable among the groups. The numbers of corpora lutea, implantation, live fetuses, and resorptions [both total and per dam], as well as pre- and post-implantation losses were comparable among the groups. There was one dead fetus [high dose]. Fetal body weights and the sex ratio were comparable among the groups. There were no statistically-significant or dose-related differences in the incidence of fetal malformations or variations [external, visceral, and skeletal].

The maternal toxicity NOAEL is 75 mg/kg/day, and the maternal toxicity LOAEL is 150 mg/kg/day, based on mortality, clinical signs of toxicity [ataxia, tremors, twitching, rapid respiration], decreased body-weight gain during dosing, and decreased food consumption during dosing. The NOAEL for developmental toxicity is 150 mg/kg/day, the highest dose tested.

This guideline developmental toxicity study is classified Acceptable, and it satisfies the guideline [OPPTS 870.3700; §83-3(a)] for a developmental toxicity study in the rodent.

	870.3700b Prenatal Developmental Toxicity Study - Rabbit
In a developmental toxicity study [MRID 41590501], female New Zealand white rabbits [16/group] were administered metaldehyde [99%] via gavage at dose levels of 0 [Mazola(R) corn oil], 10 mg/kg/day, 40 mg/kg/day, and 80 mg/kg/day from gestation day 6 through gestation day 18.

There were no treatment-related deaths or clinical signs of toxicity. Body-weight gains were extremely variable, and there was no dose-response.  All groups, including the control, displayed negative corrected body-weight gains but there was no dose-response. Food consumption was decreased at all dose levels during the dosing period compared to the control, but there was no dose-response.

Necropsy findings were comparable among the groups. There were no adverse effects observed on maternal liver weight or gravid uterine weight.

There were no abortions, and the pregnancy rate was not adversely affected by treatment. The numbers of corpora lutea, implantation, live fetuses, resorptions [both total and per dam], and dead fetuses, as well as pre- and post-implantation losses were comparable among the groups. Fetal body weights and the sex ratio were comparable among the groups. There were no statistically-significant or dose-related differences in the incidence of external or visceral malformations, but a slightly higher incidence of skeletal malformations [5 fetuses in 3 litters] was observed at the high-dose level compared to the control and lower dose groups [1 fetus/group]. This latter finding is considered attributable to the greater number of fetus examined at the high-dose level [140 fetuses in 16 litters] compared to the other groups [112 fetuses/12 litters; 104 fetuses/13 litters; and 107 fetuses/13 litters in the control, low- and mid-dose groups, respectively]. External, visceral, and skeletal variations were comparable among the groups.

The maternal toxicity NOAEL is 80 mg/kg/day, the highest dose tested. The NOAEL for developmental toxicity is 80 mg/kg/day, the highest dose tested.

This guideline developmental toxicity study is classified Acceptable, and it satisfies the guideline [OPPTS 870.3700; §83-3(b)] for a developmental toxicity study in the rodent. NOTE: Although no maternal or developmental effects were observed, the dose levels are considered adequate based on effects observed in the range-finding study. All does [5/group] in the 200, 350 and 500 mg/kg/day groups died [following 1 or 2 doses] or were sacrificed moribund [gestation days 8-12], and one doe at 100 mg/kg/day died. A repeat study at higher dose levels would not provide useful data. This is supported by the results in the rat. The maternal NOAEL in the rat developmental toxicity study is 75 mg/kg/day, based on mortality, clinical signs of toxicity [ataxia, tremors, twitching, rapid respiration], decreased body-weight gain during dosing, and decreased food consumption during dosing at the LOAEL of 150 mg/kg/day. The NOAEL for developmental toxicity is 150 mg/kg/day, the highest dose tested.

A.4.3	Reproductive Toxicity

	870.3800 Reproduction and Fertility Effects - Rat
In a 2-generation reproduction study [MRID 42823101], 28 male/28 female F0 CD[(R)] rats/sex/group were administered metaldehyde [>99% a.i.] via the diet for 10 weeks prior to mating and through gestation and lactation of one litter at dose levels of 0 ppm, 50 ppm, 1000 ppm, and 2000 ppm [F0 males: 0, 3.4, 69.37, and 138.36mg/kg/day; F0 females: 0, 4.16, 80.81, and 160.42 mg/kg/day; F1 males: 0, 3.23, 64.93, and 133.53 mg/kg/day; F1 females: 0, 4.03, 80.51, and 164.15 mg/kg/day]. Rats were mated, one male with one female. The resulting F1 litters were weaned at day 28 post partum. The F1 generation [28 rats/sex/group] was administered the test material at the same dose levels as F0 animals and mated in a similar manner, avoiding sibling matings. The resulting F2 litters were weaned at day 28 post partum.

No treatment-related clinical signs of toxicity or mortality were observed in F0 males at any time point or in F0 females during the pre-mating and mating periods or during gestation. However, at 2000 ppm, three F0 dams were sacrificed moribund during the lactation period [lactation days 16-18; days 110, 110, 113 on test] due to bilateral hindlimb paralysis. No treatment-related clinical signs of toxicity or mortality were observed in F1 males at any time point or in F1 females during the pre-mating and mating periods. However, during gestation/lactation, three F1 dams [2000 ppm] were found dead [days 95, 101, and 125]. The 2000 ppm F1 dam that was found dead on day 95 displayed ataxia, labored breathing, cold extremities, and pallor on day 94. An additional 2000 ppm F1 female  [nongravid] displayed prostration, tremors, abdominal breathing, and rapid respiration on day 102 but survived until terminal sacrifice [day 134]. The author stated that the relationship of these latter signs to treatment was unclear. The cause of death of two of the F1 females was not determined [third female due to septic emboli to various organs]. None of the other deaths [ F0 male and 2 F0 females at 50 ppm, 2 F1 females at 50 ppm, and one F1 male at 1000 ppm] was considered treatment-related. No additional treatment-related clinical signs were noted.

F0 parental animals Body weights for the treatment groups were similar to control throughout the study for both sexes. During the pre-mating dosing period, there were no consistent adverse effects on body-weight gain in either sex. Body-weight gains of the F0 high-dose males were decreased initially [weeks 0-1 (91% of control)] and during weeks 5-6 (89% of control) and weeks 8-9 (75% of control). During weeks 2-3, there was an apparent dose-related increase in body-weight gain in males at the mid- (112% of control) and high-dose (114% of control) levels. F0 females displayed a decrease in body-weight gain [66% of control] during weeks 2- 3 at the high-dose level, although statistical significance was not attained, and the standard deviation exceeded the group mean. Food consumption was not affected in either sex.

There were no consistent, treatment-related, adverse effects on body weights or body-weight gains of the F1 parental animals during the pre-mating dosing period, although both sexes at the high dose displayed a smaller body-weight gain during weeks 9-10 [males 83%; females 65% of control] than control. Food consumption was comparable among the groups [both sexes] throughout the study.

At sacrifice, necrosis and hemorrhage in the spinal cord and vertebra luxation were observed in the three high-dose F0 dams that displayed hindlimb paralysis. An additional F0 dam at 2000 ppm displayed spinal cord lesions microscopically.

At necropsy, no treatment-related adverse effects were observed in F1 animals at any dose level.

At 2000 ppm, F1 males displayed increased relative liver weights [15%] and F1 females displayed increased absolute [12%] and relative [11%] liver weights. These organ-weight changes were not accompanied by histopathological lesions and may be attributed to adaptation to the test material. NOTE: Liver weights were not determined for F0 animals.

F0 Generation. No apparent adverse effect was observed on fertility, and the mating and gestation indices were comparable among the groups. Pre-coital intervals were not reported. The duration of gestation was comparable among the groups. The number of live pups was comparable among the groups. The number of pups born dead/dying by day 1 was not affected by treatment.  Litter size was slightly lower at the high-dose level [Day 0 (13.6), Day 4 precull (13.3), Day 21 (7.5)] compared to the control [Day 0 (13.7), Day 4 precull (13.5), Day 21 (7.8)] and other dose groups [Day 0 (14.0 and 13.8), Day 4 precull (13.7 and 13.8), Day 21 (7.7 and 7.9) for low-and mid-dose groups, respectively] throughout the weaning period. The live birth index and the viability index were comparable among the groups, but the lactation index was slightly lowered [89%] at the high-dose level compared to the control [99%] and other dose groups [99%]. At the high-dose level, a slightly lower  pup body weight was observed on lactation days 7 [males 96%/females 95% of control] and 21 [95% of control], although statistical significance was not attained for either timepoint. Body-weight gains were slightly lower for both sexes at the high-dose level [94%-95% of control] compared to the control throughout lactation. The sex ratio was comparable among the groups. F1 Generation. No apparent, treatment-related, adverse effect was observed on fertility, and the mating and gestation indices were comparable among the groups. Pre-coital intervals were not reported. The duration of gestation was comparable among the groups. The high-dose group had the fewest females [22] with live born pups [27 control and 23 each at the low- and mid-dose levels].  The number of live pups was comparable among the groups. The number of pups born dead/dying by day 1 was not affected by treatment. Litter size was comparable among the groups, and the live birth index, viability index, and the lactation index were comparable among the groups. At the high-dose level, a slightly lower pup body weight was observed on lactation days 1 [males 93%/females 93% of control], 7 [females 95% of control], and 21 [males 93%/females 92% of control], although statistical significance was attained only at the day 21 time point. Body-weight gains were slightly lower for both sexes at the high-dose level [91%-93% of control] compared to the control throughout lactation.  The sex ratio was comparable among the groups.

The NOAEL for parental toxicity is 1000 ppm [males 65 mg/kg/day; females 81 mg/kg/day) and the parental LOAEL is 2000 ppm [males 133 mg/kg/day; females 160 mg/kg/day], based on mortality (F0 and F1 females), clinical signs (hindlimb paralysis in F0 females), and histopathology (spinal cord necrosis and hemorrhage, and vertebra luxation in F0 females and increased liver weight in both sexes [F1].

The NOAEL for reproductive toxicity is 2000 ppm [males 133 mg/kg/day; females 160 mg/kg/day], the highest dose tested.

The NOAEL for offspring toxicity is 1000 ppm [males 65 mg/kg/day; females 81 mg/kg/day) and the LOAEL for offspring toxicity is 2000 ppm [males 133 mg/kg/day; females 160 mg/kg/day], based on decreased pup body weight/body-weight gain [F1 and F2 pups].

This 2-generation reproduction study is classified Acceptable/Guideline. This study satisfies the guideline requirement (OPPTS 870.3800; §83-4) for a 2-generation reproduction study. The original DER set the reproductive toxicity LOEL at 2000 ppm, based on decreased pup body weight and weight gain in both sexes, which is not a reproductive toxicity endpoint but an offspring endpoint. Reproductive toxicity was not observed in this study, based on the parameters examined. It is to be noted that several parameters in the current protocol that measure reproductive effects, such as  age of vaginal opening and preputial separation; anogenital distance for F2 pups; implantations sites; estrous cycle length and periodicity (F1 weanlings); and  sperm measures, were not evaluated. These are included in the new protocol, which was not in effect at the time of the study.

A.4.4	Chronic Toxicity

	870.4100a (870.4300) Chronic Toxicity  -  Rat
See below under 870.4200

	870.4100b Chronic Toxicity - Dog
In a chronic oral toxicity study (MRID 46378401), metaldehyde (98.3% a.i.;  batch # 30202) was administered once daily for 52 consecutive weeks to groups of 4 male and 4 female Beagle dogs at dose levels of 10, 30, and 90 mg/kg/day. The amount of test material given was adjusted to each dog's actual body weight weekly.

There were three deaths [one each sex at 30 mg/kg/day and one female at 90 mg/kg/day], which occurred between weeks 37 and 46. Treatment-related clinical signs were observed from week one on at the high dose and included ataxia, emesis, tremor, twitching, and salivation. The incidence and severity of these clinical signs lessened with time from week 19, although 1 or 2 animals continued to display salivation throughout the study. One high-dose female displayed lateral position early in the study, reduced motility during most of the study, and convulsion and vocalization during week 46. Agitation was displayed by one high-dose female during weeks 6-9 and 24-52. Body weight was slightly lower in the treated dogs [males ↓7%-17%; females ↓6%-19%] throughout most of the study, although a dose-response was not always evident. At study termination, male body weights were ↓16%, ↓12%, and ↓17% and female body weights were ↓4%, ↓10%, and ↓19% with increasing dose. During the first week on test, males displayed decreased body-weight gains at all dose levels, although the decrease was inversely related to dose [↓53%, ↓34%, and ↓26% with increasing dose]. Only the mid-dose females displayed a decrease in body-weight gain initially [↓64%]. During the 0-13 week interval, males at all dose levels [↓25%, ↓17%, and ↓43% with increasing dose] and females at the mid- [63%] and high- [79%] dose levels displayed decreased body-weight gains compared to the controls. Food consumption was not adversely affected. Food efficiency values were not provided.

No lesions of the eyes or optic region were found, and there were no differences in the urinalysis parameters monitored in either sex. During the 13-week assessment, one high-dose dog of each sex did not react to the noise test, but no effects were noted in either sex at the 26- and 52-week assessments. Increases in hemoglobin, RBC, and hematocrit were observed in both sexes at the high-dose level at week 13, but only in females at week 26. Alkaline phosphatase was increased throughout the study in both sexes at the high-dose level, with the magnitude of the response from control increasing with time [both sexes]. High-dose females displayed an increase in gamma-GT throughout the study, but other liver enzyme activities [AST, ALT] were not affected by treatment. Triglycerides were increased in the high-dose females throughout the study compared to the control values.

At the high-dose level in both sexes, liver weight was increased significantly compared to the control values. There was a dose-related decrease in absolute prostate weight [↓18%, ↓29%, and ↓32% with increasing dose], a decrease in testes weight at the low- and high-dose level, and an increase in absolute and relative lung weight in high-dose males. Increased brain weight (↑5%) was observed in females at the high-dose level compared to the control. There were no apparent microscopic lesions in the liver, but atrophy and/or degeneration was observed in the testes and prostate.

The lowest-observed-adverse-effect level (LOAEL) for metaldehyde in the dog is 30 mg/kg/day, based on death and atrophy of the testes and prostate. The NOAEL is 10 mg/kg/day.

The LOAEL for clinical signs of neurotoxicity is 90 mg/kg/day, based on ataxia, emesis, tremor, twitching, and salivation that occurred in all dogs of both sexes during days 1-7. The NOAEL for clinical signs of neurotoxicity is 30 mg/kg/day.

This chronic oral toxicity study in the dog is Acceptable/Guideline, and it satisfies the guideline requirement for a chronic oral toxicity study [OPPTS 870.4100); OECD 452] in the dog.

A.4.5	Carcinogenicity

	870.4200a Carcinogenicity Study - rat
In a chronic toxicity/carcinogenicity study [MRID 42203601], 60 Sprague-Dawley CD(R) rats/sex/dose were administered metaldehyde [99 %] via the diet at concentrations of 0 ppm and 0 ppm (2 control groups), 50 ppm [males 2 mg/kg/day; females 3 mg/kg/day], 1000 ppm [males 44 mg/kg/day; females 60 mg/kg/day], 5000 ppm [males 224 mg/kg/day; females 314 mg/kg/day] for 104 weeks.

There was no adverse effect of treatment on survival of either sex, although females at the mid- [60%] and high- [58%] dose levels displayed a slightly greater mortality than the control groups [50% and 48%]. There were no apparent treatment-related clinical signs of toxicity. There was a slight reduction in body weight [↓5%] throughout most of the study in both sexes at the high-dose level compared to the control groups. During the first week, females in all treated groups displayed a dose-related [statistically-significant at all dose levels] decrease in body-weight gain compared to the 2 control groups [86%/94%, 69%/75%, and 60%/66% of control with increasing dose].  During the same time-frame, males displayed a similar dose-related decrease in body-weight gain, which was statistically significant at the mid- [87% of control] and high- [78% of control] dose level compared to one of the control groups. Food consumption was decreased at the high-dose level in both sexes during the first few weeks of the study, which suggests a palatability problem.

There were no apparent, treatment-related, effects on the ophthalmological or hematological parameters monitored in either sex. Mid- and high-dose females displayed a statistically-significant, dose-related, increase in cholesterol levels throughout most of the study. Globulin values were elevated in the high-dose females throughout most of the study [weeks 26, 52, and 78] and in mid-dose females only at week 78. There were no treatment-related alterations in the liver enzymes monitored. There was a dose-related increase in urine volume in females [37%, 40%, and 54% with increasing dose] at week 77 only.

Increased liver weight [males ↑11%-18%; females ↑21%-32%] was observed in both sexes at the high-dose level, although the values in males did not attain statistical significance. Females at all dose levels displayed an increase in ovarian weight, but there was no dose-response, and the standard deviation of the low- and high-dose female groups exceeded the means.

In the liver, there was a dose-related increase in hepatocellular hypertrophy in both sexes, which was statistically-significant at the mid-dose level in males and at the high-dose level in both sexes. There was a statistically-significant increase in hepatocellular adenomas in high-dose females [10%] compared to the control and other dose groups. The majority of the liver adenomas were observed at the terminal sacrifice, and the incidence is within the historical control incidence of the testing facility [0%-10%]. One hepatocellular carcinoma was observed in one of the control groups and in one high-dose female. The combined incidence [adenomas and carcinomas] of liver tumors in the high-dose females [11.7%] is slightly outside the historical control incidence of the testing facility [0%-10%]. Males did not display an increase in liver tumors.

The systemic toxicity NOAEL is 50 ppm [males 2 mg/kg/day; females 3 mg/kg/day], based on hepatocellular hypertrophy and increased cholesterol in both sexes and decreased body-weight gain in females at the systemic LOAEL of 1000 ppm [males 44 mg/kg/day; females 60 mg/kg/day].

This guideline chronic toxicity/carcinogenicity study is classified ACCEPTABLE, and it satisfies the guideline [OPPTS 870.4300; §83-5] for a chronic toxicity/ carcinogenicity study in the rat.

	870.4200b Carcinogenicity (feeding) - Mouse
In a carcinogenicity study [MRID 42737201], 60 CD-1 mice/sex/dose were administered metaldehyde [>99%; Lot # 5448] via the diet at concentrations of 0 ppm [2 control groups], 25 ppm [males  4.0 mg/kg/day; females 4.8 mg/kg/day], 100 ppm [males 15.9 mg/kg/day; females 19.7 mg/kg/day], and 300 ppm [males 48.9 mg/kg/day; females 59.8 mg/kg/day] for 18 months.

There were no treatment-related effects on survival or clinical signs in either sex, and body weights, body-weight gains, and food consumption were comparable among the groups for both sexes.

The hematologic parameters monitored were comparable among the groups [both sexes]. Clinical chemistry and urinalysis parameters were not monitored.

At necropsy, there were no gross lesions attributed to treatment in either sex. With the exception of liver weights in males, which displayed a dose-related increase (although statistical significance was not attained), organ weights were comparable among the groups [both sexes].

Non-neoplastic lesions: The incidence [overall: high-dose males 62% vs 30%-33% control; high-dose females: 30% vs 7%-15% control] and severity of hepatocellular hypertrophy were increased in both sexes at the high-dose level compared to the control groups. The majority of the mice with hepatocellular hypertrophy were diagnosed at terminal sacrifice.

Neoplastic lesions: There was no statistically-significant increase in the incidence of liver tumors in either sex, although the high-dose males displayed a slight increase [15 adenomas and 3 carcinomas] compared to both control groups [8 adenomas/1 carcinoma and 8 adenomas/3carcinomas].

The systemic toxicity NOAEL is 100 ppm [15.9 mg/kg/day (males); 19.7 mg/kg/day (females)], based on a significantly increased incidence of hepatocellular hypertrophy in both sexes at the LOAEL of 300 ppm [48.9 mg/kg/day (males); 59.8 mg/kg/day (females)]. No other toxicological effects were observed in either sex. The incidence of tumors was comparable among the groups [both sexes].

This guideline carcinogenicity study is classified ACCEPTABLE/Guideline. However, the dose levels were not considered adequate for assessing the carcinogenic potential of metaldehyde, and a supplementary study was performed [MRID 44625101; separate DER]. In the 90-day mouse study [not submitted to the Agency] performed to determine dose levels to be used in the current study, mortality was said to have been observed at 3000 ppm and 10000 ppm and dose-related increases in liver weight and hepatic lesions were reported in both sexes at >=300 ppm. The supplemental carcinogenicity study [MRID 44625101] was performed using one dose level of metaldehyde [1000 ppm]. At 1000 ppm, there was a treatment-related increase in the incidence of hepatocellular adenomas in both sexes when compared to controls. Dosing was considered adequate based on the increased incidence of liver lesions [liver single cell/focal/multifocal necrosis (males) and hepatocellular eosinophilic cell foci (females)] in both sexes, in addition to hepatocellular hypertrophy (both sexes), which was the only treatment-related finding in the current study at 300 ppm. When all the information, including the 90-day study (MRID 43297701), are considered together, MRID 42737201 and MRID 44625101 satisfy the guideline requirement [OPPTS 870.4200; §83-2] for a carcinogenicity study in the mouse.

In a carcinogenicity study [MRID 44625101], metaldehyde was administered to 60 Crl:CD-1(R)-(ICR)BR mice/sex/dose via the diet at dose levels of 0, 0, and 1000 ppm [equivalent to 0, 0, 135 mg/kg bw/day (males)/163 mg/kg bw/day (females)] for at least 78 weeks.

There were no compound-related effects on mortality, clinical signs, body weight, food consumption, or hematology in either sex. With the exception of the liver, organ weights were comparable to those of the control groups for both sexes. Liver weights were increased significantly in both sexes at 1000 ppm compared to both of their respective control groups.  Gross and histologic pathology findings were comparable among the groups for both sexes, with the exception of the liver. Hepatocellular hypertrophy was observed in both sexes at 1000 ppm. Males at 1000 ppm displayed single cell necrosis, focal or multifocal necrosis, pigment accumulation, and sinusoidal. Females at 1000 ppm displayed a small increase in the incidence of hepatocellular eosinophilic cell foci. There was a significant increase in the incidence of hepatocellular adenomas in both sexes [males: 4 and 5 vs 14; females: 1 and 0 vs 5], with the males displaying the greater effect. Males also displayed a slight increase in hepatocellular carcinomas [2 and 2 vs 4] compared to both control groups.

Under the conditions of this study, at the only dose of metaldehyde tested [1000 ppm; 135 (males)/163 (females) mg/kg/day)], increased liver weight (both sexes), hepatocellular hypertrophy (both sexes), liver single cell/focal/multifocal necrosis (males), liver pigment accumulation (males), sinusoidal histiocytosis (males), hepatocellular eosinophilic cell foci (females), and hepatocellular adenomas (both sexes) were observed. The NOAEL is not established in the current study. However, based on a previous mouse carcinogenicity study in the same strain of mouse [MRID 42737201], in which an increased incidence of hepatocellular hypertrophy was observed in both sexes at the highest dose tested [300 ppm; 48.9 (males)/59.8 (females) mg/kg/day], the NOAEL is 100 ppm [15.9 (males)/19.7 (females) mg/kg/day], with the LOAEL based on an increased incidence of hepatocellular hypertrophy in both sexes.

At the dose tested in the current study, there was a treatment related increase in the incidence of hepatocellular adenomas in both sexes when compared to the controls. Dosing was considered adequate based on the increased incidence of liver lesions [liver single cell/focal/multifocal necrosis (males) and hepatocellular eosinophilic cell foci (females)] in both sexes, in addition to the hepatocellular hypertrophy observed in the previous study at 300 ppm.

This carcinogenicity study in the mouse is Acceptable/non-guideline. It is non-guideline since only one dose level was tested. The study was performed as a supplement to a previous 18-month mouse carcinogenicity study [MRID 42737201] and should be considered along with the previous study. Together, the two studies satisfy the guideline requirement for a carcinogenicity study [OPPTS 870.4200; OECD 451] in mice.

A.4.6	Mutagenicity

	Gene Mutation
Guideline 870.5100, reverse gene mutation assay in bacteria
MRID 48666101 (2011)
Classification: acceptable/guideline
Salmonella typhimurium strains TA98, TA100, TA102, TA1535, and TA1537; concentrations of 0, 3, 10, 33, 100, 333, 1000, 2500, or 5000 ug/plate (+/- S9-activation); insoluble at >=2500 ug/plate +/-S9.
 No evidence of induced mutant colonies over background.

	Cytogenetics
Guideline 870.5300, in vitro mutagenicity (mammalian forward gene mutation)
MRID 48721401 (2011)
Classification: acceptable/guideline
Tested up to solubility limit (>= 600 ug/mL +/-S9); failed to induce either a cytotoxic or a mutagenic effect.  There was no evidence of induced mutant colonies over background.

Guideline 870.5385, in vivo cytogenetic mutagenicity assay
MRID 48788201 (2012)
Classification: acceptable/guideline
in vivo rat bone marrow chromosome aberration test at doses of 0, 62.5, 125, and 250 mg/kg (M) or 0, 31.25, 62.5, and 125 mg/kg (F); no evidence of cytogenicity in this whole animal chromosome aberration assay.

	Other Genotoxicity
Guideline 870.5395, micronucleus assay
MRID 42044006 (1990)
Classification; Unacceptable/guideline
highest dose tested (100 mg/kg); MTD not  reached

A.4.7	Neurotoxicity

	870.6200 Acute Neurotoxicity Screening Battery

Study was waived by HASPOC (TXR# 0056524; dated 2/21/13).

	870.6200 Subchronic Neurotoxicity Screening Battery
In a subchronic neurotoxicity study (MRID 46223401), metaldehyde (98.3% a.i., batch # 31509) was administered via the diet to 10 Sprague-Dawley Crl:CD(R) (SD) IGS BR rats/sex/group at dose levels of 0 [basal diet], 100, 500, and 2500 ppm (equivalent to 0, 8, 39, 185 mg/kg bw/day) for 90 consecutive days. Clinical signs, body-weight development, food and water consumption were monitored during the study, and ophthalmoscopic examination of the control and high-dose rats was performed pre-test and during final week of the study. Neurobehavioral assessment (functional observational battery and motor activity testing) was performed in all rats/sex/group prior to the start of dosing and during weeks 2, 4, 8, and 12. At study termination, 5 animals/sex/group were euthanized and perfused with gluteraldehyde: paraformaldehyde via the heart, following initial whole-body perfusion with heparinzed saline, for neuropathological examination. Of the perfused animals, all control and high-dose rats were subjected to histopathological evaluation of brain and peripheral nervous system tissues.One high-dose female was sacrificed [day 22] due to poor condition [bilateral hindlimb paralysis], which was observed initially on day 10. There were no other treatment-related deaths. Body weights and body-weight gains of the males were comparable among the groups throughout the study. Females at the mid- and high-dose levels displayed slightly lower body weights [↓5%-6%] throughout the study. Body-weight gains of the mid-dose females [80% of control; not statistically significant] and high-dose females [↓30%; statistically significant] were lower during the first week and remained lower than control throughout the study, although statistical significance was not attained and a dose-response was not always apparent. Food consumption was comparable among the male groups but lower than control in the high-dose females throughout the study. Food efficiency was comparable among the groups for both sexes. No ocular effects were observed in either sex.

Differences in motor activity parameters were observed sporadically, but there was no consistent dose response, some standard deviations were greater than the means, and statistical significance was rarely attained. Differences in grip strength and startle reflex values were observed sporadically also, but there was no consistent dose response and statistical significance was rarely attained.

At termination, no macroscopic abnormalities were reported for either sex. No treatment-related changes were observed in brain weight for either sex, and no treatment-related histopathological alterations were reported in either sex.

NOTE: The positive control data [February-April, 2003] bring into question the capability  the testing facility had to adequately assess neurotoxicity at the time the metaldehyde study was performed [February-October, 2002]. Additionally, the available positive control data do not provide adequate evidence of the ability of the testing facility to identify a neurotoxic compound. Since the trimethyltin [1 mg/kg] animals did not survive to study termination, no FOB assessment was performed on these animals [no motor activity, grip strength, startle reflex]. Neuropathology was demonstrated following trimethyltin exposure, however. The only neuropathological findings in the acrylamide-treated animals [15 mg/kg] were contraction vacuoles in the sciatic and/or tibial nerves, mainly in females. No axonal degeneration was observed. Findings in the acrylamide females were not observed in the acrylamide males, and a sex difference following acrylamide exposure is not expected. Individuals performing the various assessments were not identified in either the metaldehyde study or the positive control study, and methodology and apparatus descriptions are not adequate. Further, a more definitive explanation/presentation of the data, especially the motor activity data are required.

Provisionally, the LOAEL for neurotoxicity can be set at 500 ppm [39 mg/kg/day], based on increased motor activity in females. The NOAEL can be set at 100 ppm [8 mg/kg/day]. At the highest dose tested [2500 ppm (185 mg/kg)], bilateral hindlimb paralysis was observed in one female, and females displayed decreased body-weight gains during the first week of the study.

The study is classified as Unacceptable (guideline), and it does not satisfy the guideline requirement for a subchronic neurotoxicity study in rats (870.6200b). The study is classified Unacceptable since the results suggest little neurotoxicity following exposure to metaldehyde; more importantly, the positive control data submitted do not demonstrate proficiency of the testing facility to detect alterations in the neurotoxicity parameters monitored.

A.4.8	Metabolism

	870.7485	Metabolism - Rat
In a metabolism study in rats (MRID 42300901),the absorption, distribution, metabolism and excretion of metaldehyde were studied in groups of male and female Sprague-Dawley rats administered a single oral gavage dose of 10 or 100 mg/kg 14C-metaldehyde or following repeated oral dosing of 10 mg/kg non-labeled metaldehyde for 14 days followed by a single dose of labeled metaldehyde on day 15. In addition, the pharmacokinetics of metaldehyde was evaluated in rats receiving a single oral dose of 10 mg/kg labeled metaldehyde.

Metaldehyde was rapidly absorbed, distributed, and metabolized in rats for all dosing regimens. The 7-day recoveries were >94% for all groups. Most of the radioactivity was recovered in expired air (78-98% of administered dose) within 24 hours (48 hours for high-dose females), the majority of which was reported to be [14]CO2. Recovery in urine and feces was low for all dosing groups (2.5-5.1%). Slight sex-, dose-, and regimen-related effects on metaldehyde excretion were found. The recovery of administered radioactivity was greater in low-dose animals than in high-dose and repeated dose animals. The pharmacokinetics study showed that males reached peak blood levels and excreted radioactivity faster than females. The concentration of total radioactivity in the blood at peak levels was similar for both sexes, but the concentration of intact metaldehyde was >50% higher in females than in males at peak, first and second blood half-lives.

Recovered radioactivity in tissues/carcass after 7 days was similar for all dose groups (7-11% of administered dose). High concentrations of radioactivity were recovered in nervous tissue, fat, liver, and reproductive organs. Tissue examination of low-dose animals showed that radioactive residues (percent of administered dose) were highest in the carcass at peak, first and second blood half-lives. At second blood half-life, percent dose in the liver exceeded that of any other tissue (except carcass) in both males and females. No clinical signs of toxicity were observed.

Classified acceptable for a metabolism study under Guideline series 85-1.

A.4.9	Immunotoxicity

	870.7800	Immunotoxicity
The immunotoxicity study (870.7800) is a data gap and toxicology data requirement for metaldehyde.

Appendix B. Metabolism Summary Table

           Table B.1 - Tabular Summary of Metabolites and Degradates

                                Chemical Name

                                   Commodity
                              Percent TRR (PPM) 1
                                   Structure

                    Matrices - Major Residue2 (>10%TRR)
                   Matrices - Minor Residue[2] (<10%TRR)

Parent:
Metaldehyde
Lettuce
                                     95.3

Sugar beet - root
                                      35

Sugar beet - top
                                      33

Rat

                                       *

Degradate:
Non-Extractable Residues
Lettuce

                                     <5

                                      N/A

Sugar beet - root
                                     43.4

Sugar beet - top
                                     43.2

Rat
                                      ND
                                    2.5-5.1

CO2
Rat
                                     78-98

Lettuce; 43923301; 13.8 lb ai/A; 10x; single directed application; 28 days.

Sugar beets; 43923302; 13.76 lb ai/A; 10x; single directed application; 48 days.

Rat: 42300901; single gavage dose 10 or 100 mg/kg, repeated dose 10 mg/kg/day for 14 days, then single dose 14C [10 mg/kg], Sprague-Dawley, 1 day depuration

* = metaldehyde and acetaldehyde detected in plasma; no quantification available at this time.
ND = not detectable
Note 1: Confined Rotational Crop waiver granted by CHEMSAC on 12/9/04.
Note 2: Livestock metabolism and feeding studies (ruminant & poultry) waiver granted  Metaldehyde: 3/11/97)

Appendix C.  Physical/Chemical Properties

TABLE C.1.	Physicochemical Properties of Metaldehyde
Parameter
Value
Reference
Melting point/range
246°C
Metaldehyde RED, PC Chapter
pH
Not applicable due to the low solubility of metaldehyde in water.
                                      N/A
Density
1.27 g/cm[3]
                          Metaldehyde RED, PC Chapter
Water solubility (20°C)
0.222 g/L at 20°C

Solvent solubility
(g/L at 20.3-22.4°C)
5.21 x 10[-2]  in hexane
0.53            in toluene
1.56            in tetrahydrofuran
1.73            in methanol

Vapor pressure
1 mm Hg at 20°C
6.6 +- 0.3 Pa at 25°C

Dissociation constant (pKa)
3.5 Pa (m[3]/mol) (Henry's Law Constant)

Octanol/water partition coefficient, Kow
1.33 (log Kow = 0.12) at 20°C

Appendix D.  Review of Human Research

This risk assessment relies in part on data from studies in which adult human subjects were intentionally exposed to a pesticide or other chemical.  These data, which include studies from the PHED 1.1, the AHETF database, and the ARTF database are (1) subject to ethics review pursuant to 40 CFR 26, (2) have received that review, and (3) are compliant with applicable ethics requirements.  For certain studies, the ethics review may have included review by the Human Studies Review Board.  Descriptions of data sources, as well as guidance on their use, can be found at the Agency website.