[Federal Register Volume 83, Number 227 (Monday, November 26, 2018)]
[Notices]
[Pages 60527-60529]
[FR Doc No: 2018-25735]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-84633; File No. SR-NASDAQ-2018-091]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend The Nasdaq Options Market LLC (``NOM'') Fees

November 20, 2018.
    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 November 9, 2018, The Nasdaq Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III, below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b 4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend The Nasdaq Options Market LLC
(``NOM'') fees within Chapter XV, Section 3, titled ``Nasdaq Options
Market--Ports and Other Services.''
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaq.cchwallstreet.com/, at the principal office of
the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of the proposed rule change is to define ``account
number'' and utilize that term within Chapter XV, Sections 3 and 9.
Each change will be described in more detail below.
New Defined Term ``Account''
    The Exchange proposes to adopt a new definition within Chapter XV,
Section 3 and apply this definition within Chapter XV, Sections 3 and
9. The purpose of this defined new term ``account number'' is to
conform the Exchange's use of certain terms within NOM Rules. This term
would be utilized in Chapter XV to describe the manner in which pricing
is calculated. Recently, the Nasdaq affiliated exchanges filed rule
changes to conform the usage of various terms across its 6 affiliated
options markets within the various rulebooks.\3\ The Exchange believes
that utilizing the same defined terms, where possible, across its 6
affiliated options markets will avoid confusion for certain rules and
pricing purposes. The term ``account number'' can be defined
identically across Nasdaq's 6 affiliated options markets for purposes
of pricing ports. The Exchange is not amending the manner in which
pricing will be applied with respect to this particular change. The
Exchange proposes to utilize the defined term ``account number'' in
place of the term ``mnemonic,'' which was not defined in the pricing
rules. The insertion of the new defined term is intended to add more
specificity and clarity to the current pricing.
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    \3\ NOM has filed to define the terms ``account number,''
``badge'' and ``mnemonic'' at Chapter I, Section 1(a)(69), (70) and
(71) respectively. See SR-NASDAQ-2018-085 (not yet published)
[published on November 16, 2018]. Nasdaq Phlx LLC has filed to
define the terms ``account number,'' ``badge'' and ``mnemonic'' at
Rule 1000(b)(51), (52) and (53) respectively. See SR-Phlx-2018-69
(not yet published). Nasdaq BX, Inc. has filed to define the terms
``account number,'' ``badge'' and ``mnemonic'' at Chapter I, Section
1(a)(70), (71) and (72) respectively. See Securities Exchange Act
Release No. 84520 (November 1, 2018) (SR-BX-2018-050) (not yet
published) [published on November 7, 2018]. See also ISE Rule
100(a)(1), (5) and (34) which defines the terms ``account number,''
``badge'' and ``mnemonic,'' respectively. See also GEMX Rule
100(a)(1), (5) and (35) which defines the terms ``account number,''
``badge'' and ``mnemonic,'' respectively. See also MRX Rule
100(a)(1), (5) and (36) which defines the terms ``account number,''
``badge'' and ``mnemonic,'' respectively.
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    At this time, the Exchange proposes to define an ``account number''
within Chapter XV, Section 3 to mean a number assigned to a
Participant. Participants may have more than one account number. The
term ``mnemonic'' has been used frequently throughout Chapter XV
without being defined. The Exchange proposes to remove the term
``mnemonic'' from Chapter XV, Section 3 and replace the term with the
defined term ``account number'' for FIX and the OTTO protocols. The
Exchange notes that the terms mnemonic and account number were being
used interchangeably. The Exchange recently defined both terms in its
rules.\4\ The term account number is appropriate to describe these
fees. The Exchange is not amending the manner in which it assesses
those port fees, rather the Exchange simply proposes to utilize the new
term to better describe its current pricing.
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    \4\ A ``mnemonic'' is defined as an acronym comprised of letters
and/or numbers assigned to Participants. A Participant account may
be associated with multiple mnemonics. See SR-NASDAQ-2018-085 (not
yet published) [published on November 16, 2018]. Mnemonics are
issued to Participants to identify associated persons of
Participants.
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    Also, the Exchange proposes to remove the term ``mnemonic'' from
the CTI Port Fee, FIX DROP Port Fee, OTTO DROP Fee, ITTO Port Fee and
Bono Port Fee. Today, these ports are assessed only one fee per port,
per month and therefore adding the term ``per account number'' would be
redundant and unnecessary. These ports are associated with one account
number. The Exchange is not proposing to amend the manner in which
these ports are assessed, rather the Exchange proposes to eliminate the
``per mnemonic'' description. The Exchange believes that the billing is
clearly defined as ``per port, per month.''
    Account number is also being defined in Section 9, ``Account Fee--
Options.'' The Exchange is not amending the manner in which this fee is
billed, rather the Exchange is defining the term account number within
Section 9. The defined term account number will be utilized
consistently throughout the NOM pricing, where applicable.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\5\ in general, and furthers the objectives of Sections
6(b)(4) and 6(b)(5) of the Act,\6\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees and other charges

among members and issuers and other persons using any facility, and is
not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers.
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    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(4) and (5).
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New Defined Term ``Account''
    The Exchange's proposal to define the term ``account number''
within Chapter XV, Sections 3 and 9 and apply that term within Chapter
XV, Section 3, in place of the term ``mnemonic'' as to the manner in
which FIX and OTTO Port Fees are priced is reasonable because the term
is defined and will be utilized consistently throughout Chapter XV,
where applicable. The usage of the defined term ``account number'' will
bring uniformity to the term and its usage across the 6 affiliated
options markets. The proposed change to utilize the defined term will
not amend the manner in which the ports are billed, rather it will also
bring greater clarity to pricing in Chapter XV, Sections 3 and 9.
    The Exchange's proposal to define the term ``account number''
within Chapter XV, Sections 3 and 9 and apply that term within Chapter
XV, Section 3, in place of the term ``mnemonic'' for the FIX and OTTO
Port Fees is equitable and not unfairly discriminatory because the
Exchange proposes to apply that term uniformly in billing Participants
utilizing those ports and for purposes of the Account Fee.
    The Exchange's proposal to remove the term ``mnemonic'' for the
pricing of the CTI Port Fee, FIX DROP Port Fee, OTTO DROP Fee, ITTO
Port Fee and Bono Port Fee is reasonable because, today, these ports
are assessed only one fee per port, per month and this change will
bring greater clarity to the manner in which these services are billed.
The term ``mnemonic'' was undefined until the Exchange filed SR-NASDAQ-
2018-085.\7\ The manner in which the term ``mnemonic'' was defined for
purposes of NOM's Rules is not the manner that was intended for pricing
these ports. To that end, the Exchange proposes to remove the term
``mnemonic'' and replace that term with ``account number,'' where
applicable, to convey the intended manner in which the Exchange prices
ports. Today, these ports are assessed only one fee per port, per month
and therefore adding the term ``per account number'' would be redundant
and unnecessary. These ports are associated with one account number.
This proposal will conform the defined term across NOM Rules.\8\ The
Exchange is not proposing to amend the manner in which these ports are
assessed, rather the Exchange proposes to eliminate the ``per
mnemonic'' description and more clearly define the manner in which
these services are billed as ``per port, per month.''
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    \7\ This rule change is not yet published [published on November
16, 2018].
    \8\ See Chapter I, Section 1(a)(69).
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    The Exchange's proposal to remove the term ``mnemonic'' for the
pricing of the CTI Port Fee, FIX DROP Port Fee, OTTO DROP Fee, ITTO
Port Fee and Bono Port Fee is equitable and not unfairly discriminatory
because the Exchange will continue to uniformly assess all market
participants these services in a uniform manner. The proposed change
does not amend the manner in which these services are billed.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. In terms of inter-market
competition, the Exchange notes that this proposal does not amend
actual fees, rather the Exchange proposes to define a new term to be
used more accurately to describe the manner in which certain services
within Chapter XV, Sections 3 and 9 are billed.
New Defined Term ``Account''
    The Exchange's proposal to define the term ``account number''
within Chapter XV, Sections 3 and 9 and apply that term within Chapter
XV, Section 3, in place of the term ``mnemonic'' with respect to the
manner in which FIX and OTTO protocols are priced does not impose an
undue burden on intra-market competition because the Exchange proposes
to apply that term uniformly in billing Participants utilizing those
ports and for purposes of the Account Fee. No changes are being made to
the manner in which the Exchange bills these ports.
    The Exchange's proposal to remove the term ``mnemonic'' for the
pricing of the CTI Port Fee, FIX DROP Port Fee, OTTO DROP Fee, ITTO
Port Fee and Bono Port Fee does not impose an undue burden on intra-
market competition because the Exchange will continue to uniformly
assess all market participants these services in a uniform manner. The
proposed change does not amend the manner in which these services are
billed.

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\9\
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    \9\ 15 U.S.C. 78s(b)(3)(A)(ii).
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    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: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-NASDAQ-2018-091 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-NASDAQ-2018-091. 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-NASDAQ-2018-091 and should
be submitted on or before December 17, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
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    \10\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-25735 Filed 11-23-18; 8:45 am]
 BILLING CODE 8011-01-P


Data Requirement:				PMRA DATA CODE 	{............}
                        EPA DP Barcode			460199
                        OECD Data Point		{............}
                        EPA MRID 				51499402
                        EPA Guideline			850.4500

Test material:	Dacthal W-75 [ai: chlorthal-dimethyl (Dacthal)]		Purity:	74.6%
Common name	Dacthal W-75
Chemical name:	IUPAC: dimethyl 2,3,5,6-tetrachlorobenzene-1,4-dicarboxylate
            CAS name: Not reported
            CAS No.: 1861-32-1
            Synonyms: Not reported

Primary Reviewer:	Julie Burns								Signature:
Environmental Scientist, CDM/CSS-Dynamac JV				Date:   04/07/2021
Secondary Reviewer:   Moncie V. Wright, Ph.D.				Signature:
Environmental Scientist, CDM/CSS-Dynamac JV				Date:   04/16/2021

Primary Reviewer:	Christina M. Wendel						Signature:
EPA/OPP/EFED/ERB2/Biologist 								Date: 10/25/2021

Secondary Reviewer(s): Michael Wagman						Signature:
EPA/OPP/EFED/ERB2/Senior Scientist						Date: 11/19/2021

Reference/Submission No.:  {.....................}

Company Code 		{............}	[For PMRA]
Active Code			{............}	[For PMRA]
Use Site Category:	{............}	[For PMRA]
EPA PC Code 		078701

Date Evaluation Completed: 19-11-2021

CITATION: Manson, P.S. 2004. DACTHAL W-75: Inhibition of Growth to the Alga Selenastrum capricornutum. Study conducted by Covance Laboratories Ltd., North Yorkshire, England. Laboratory report number 1708/038-D2149. Study sponsored by AMVAC Chemical UK Ltd., Surrey, England. Study initiated on September 19, 2003 and completed on April 5, 2004.

This Data Evaluation Record may have been altered by the Environmental Fate and Effects Division subsequent to signing by CDM/CSS-Dynamac JV personnel. The CDM/CSS-Dynamac Joint Venture role does not include establishing Agency policies.

EXECUTIVE SUMMARY:

In a 96-hour acute toxicity study, cultures of green algae Pseudokirchneriella subcapitata (formerly Selenastrum capricornutum) were exposed to Dacthal W-75 [ai: chlorthal-dimethyl (Dacthal); formulation of DCPA] under static conditions at nominal formulation concentrations of 0 (control), 6.3, 12.5, 25, 50, and 100 mg form/L. The corresponding nominal concentrations of the active ingredient were 4.70, 9.33, 18.7, 37.3, and 74.6 mg a.i./L. The test item was stable under the testing conditions (based on comparison to initial measured concentrations), although there were solubility issues as evidenced by the poor recoveries present at test initiation (three of the lowest test levels had recoveries <=72% of nominal) and observations made at that time. The mean-measured active ingredient concentrations of <0.003 (<LOD, control), 2.57, 6.43, 11.3, 31.3, and 61.0 mg a.i./L were used for analysis and reporting.

The % growth inhibition in the treated algal cultures relative to the negative control ranged from 7 to 29%. The observed inhibitions after the lowest test level were considered to be dose responsive, with a general monotonic trend. The yield, growth rate, and area under the curve (AUC) were significantly affected by the test material at all test concentrations; however, the reviewer determined, that although there were effects at the lowest test level, they were not dose responsive, and could be discounted. Therefore, based on this the reviewer determined that the more reliable NOAEC was 6.43 mg a.i./L. No inhibitions reached 50% or greater and the IC50 was >61.0 mg a.i./L. The overall most sensitive endpoint was yield, growth rate, and area under the curve, based on a NOAEC of 6.43 mg a.i./L and a LOAEC of 11.3 mg a.i./L.

There was a major change in pH over the study duration. In all treatment groups, the pH ranged from 8.0 to 8.1 at test initiation and ranged from 10.2 to 10.4 at 96 hours. In the control, pH increased from 7.9 at test initiation to 10.2 at test termination, resulting in an increase of 2.3 units in the negative control. The increase in pH was likely due to high rates of algal growth reaching the capacity of the test system. Had pH measurements been taken more frequently (i.e., daily), there would be more certainty that the similar dose-responses (and consequent NOAEC and IC50 endpoints) observed in treatment groups at 24-hours and 72-hours, compared to the treatments at 96-hours, were not a result of inhibitions in control growth due to high pH.

This study is scientifically sound and is classified as supplemental and may be used for risk characterization.

Results Synopsis

   Test Organism: Green algae, Selenastrum capricornutum
   Test Type (Flow-through, Static, Static Renewal): static

   Yield
   IC05: Not calculable				95% C.I.:  N/A
   IC50: >61.0 mg a.i./L				95% C.I.:  N/A
   NOAEC: 6.43 mg a.i./L*
   LOAEC: 11.3 mg a.i./L

   Growth rate
   IC05: Not calculable				95% C.I.:  N/A
   IC50: >61.0 mg a.i./L				95% C.I.:  N/A
   NOAEC: 6.43 mg a.i./L*
   LOAEC: 11.3 mg a.i./L

   Area under the curve (AUC)
   IC05: Not calculable				95% C.I.:  N/A
   IC50: >61.0 mg a.i./L				95% C.I.:  N/A
   NOAEC: 6.43 mg a.i./L*
   LOAEC: 11.3 mg a.i./L
   *See reviewer's comments

   Endpoint(s) Affected:  Yield, growth rate, and area under the curve (AUC)
   Most Sensitive Endpoint:  Yield, growth rate, and area under the curve (AUC), based on the NOAEC
I. MATERIALS AND METHODS

   GUIDELINE FOLLOWED:		The study author conducted the test according to the requirements of Annex II to Commission Directive 91/414/EEC as amended by Directive 96/12/EC Annex I 8.2 referring to Commission Directive 92/69/EEC:C3 Algal Inhibition Test,  the OECD Guidelines for Testing Chemicals No. 201: Alga, Growth Inhibition Test, and the U.S. EPA OCSPP draft guideline 850.4500 Algal Toxicity, Tiers I and II (April 1996). The reviewer assessed the study according to OECD Guideline 201: Freshwater Alga and
                           Cyanobacteria, Growth Inhibition Test (2011) and OCSPP Number 850.4500: Algal Toxicity (2012), noting similarities and/or differences where they occurred. The following deficiencies and deviations were noted:

 There were solubility issues as evidenced by the poor recoveries present at test initiation (three of the lowest test levels had recoveries <=72% of nominal) as well as the study author's visual observations of white homogeneous liquid dispersions (second and third test levels), white non-homogeneous liquid dispersions with particulate matter at the bottom of the test vessel (second to highest and highest test levels), and particulate matter at the bottom of the test vessel (highest test level only). OCSPP 850.1000 recommends pre-testing to determine the limit of solubility, to test with different solvents to aid dissolution, in addition to using sonication, centrifugation or filtration, or minor adjustments to environmental conditions in testing to improve solubility. However, the concentrations at 96-hours represented 83 to 116% of the initial-measured concentrations, which indicated that the concentrations were stable over the duration of the study, although there appears to be issues with solubility.
 The pH in the negative control increased by 2.3 units over the course of the test (7.9 to 10.2). OECD guidance recommends that the pH of the control should not increase by more than 1.5 units during the study. OCSPP does not provide guidance for pH increases in the control. In all treatment groups, the pH ranged from 8.0 to 8.1 at test initiation and ranged from 10.2 to 10.4 at 96 hours. The increase in pH was likely due to high rates of algal growth reaching the capacity of the test system. This is supported by the 96-hour samples in test vessels without algal cells, which had measured pH values of only 7.9-8.1. Laboratory toxicity tests should be conducted in environmentally relevant conditions which may not be represented by the strongly basic water conditions present in the Day 4 algal samples. These conditions may have inhibited growth in the controls and lower treatment groups, resulting in potentially less sensitive endpoints than would have occurred had the pH stayed in environmentally-relevant ranges. Had pH measurements been taken more frequently (i.e., daily), there would be more certainty that the similar dose-responses (and consequent NOAEC and IC50 endpoints) observed in treatment groups at 24-hours and 72-hours, compared to the treatments at 96-hours, were not a result of inhibitions in control growth due to high pH.
 The deionized water was not reagent grade quality as recommended by OCSPP. OECD does not recommend that the deionized water is of reagent grade quality.
 The age of the inoculum at test initiation was not reported. This is considered to be a minor deficiency.
 The environmental conditions during acclimation were not reported and the health of the organisms during acclimation was not reported. This is considered to be a minor deficiency.
 Several dilution water quality parameters (hardness, alkalinity, COD, TOC, conductivity, pH, etc.) were not reported. The OCSPP guideline recommends that these parameters are measured and that these water quality characteristics meet EPA specifications.
 The study author did not report if treatments were randomly assigned to test vessels, which is a test validity element under OCSPP 850.4500, and is recommended by OECD guidance.
 Each test level had three replicates per level, as accepted by OECD. OCSPP recommends a minimum of four replicates per treatment level. The control group had 6 replicates, meeting the criteria for the control.
 Incomplete physiochemical properties of the test item were reported.

      These deficiencies and deviations do affect the validity of the study.

   COMPLIANCE:				Signed and dated Quality Assurance and GLP compliance statements were provided. A statement of No Data Confidentiality Claims was provided, but a signature was missing from the statement. This study was performed in compliance with the UK Statutory Instrument 1999 No. 3106, the GLP regulations 1999, and the OECD principle of GLP (revised 1997) ENV/MC/CHEM(98)17.
   A. MATERIALS:

   	1. Test material:				Dacthal W-75 [ai: chlorthal-dimethyl (Dacthal)]

      Description: 				Off-white powder
      Lot No./Batch No.: 			2227 (batch no.)

      Purity: 						74.6%

      Stability of compound
      under test conditions:		Stable. The concentrations at 96-hours represented 83 to 116% of the initial-measured concentrations. There were solubility issues as evidenced by the poor recoveries present at test initiation (three of the lowest test levels had recoveries <=72% of nominal) as well as the study author's visual observations of precipitates in the culture media at test termination.
      							(OECD recommends stability in water and light)

      Storage conditions of
      test chemicals: 				All precautions required in the handling, storage, and disposal of the test substance normally taken for a new chemical undergoing safety evaluation was outlined by the Sponsor. Further details were not provided.

		Physicochemical properties of Dacthal W-75 [ai: chlorthal-dimethyl (Dacthal)].
Parameter
Values
Comments
Water solubility at 20°C
Not reported

Vapor pressure
Not reported

UV absorption
Not reported

pKa
Not reported

Kow
Not reported

   2. Test organism:

         Name:					Green algae, Selenastrum capricornutum
                           This test is conducted with a nonvascular species, including at a minimum the freshwater alga P. subcapitata (formerly S. capricornutum), freshwater diatom N. pelliculosa, and the marine diatom S. costatum. Other test species may need modification of the test method. For Tier I studies, only the freshwater alga P. subcapitata is recommended. The cyanobacterium A. flos-aquae test is found in EPA guideline 850.4550.
                           OECD suggests the following species are considered suitable: S. capricornutum, S. subspicatus, and C. vulgaris. If other species are used, the strain should be reported.
         Strain:					CCAP 278/4
         Source: 					Sourced from an axenic culture derived from the Culture Collection of Algae and Protozoa (CCAP), CEH Windermere, The Ferry House, Far Sawrey, Ambleside, Cumbria, UK.
                           EPA recommends algae be from the same source and stock culture or commercial sources.
         Age of inoculum:		Not reported
                           EPA recommends the algal inoculum should be from logarithmically growing stock cultures (typically 3- to 7-days old).
         Method of cultivation:	Maintained in liquid culture. Further details provided in Appendix 1 pages										31-32 of the study report.

   B.  STUDY DESIGN:

      1. Experimental Conditions

         a. Range-finding study: A range finding study was conducted at nominal active ingredient concentrations of 0.00746, 0.0746, 0.746, 7.46, and 74.6 mg/L based on the 74.6% purity of the active ingredient. After 96 hours, treatment group inhibitions in area under the curve relative to the control were 0, 24, 0, 21, and 0%, respectively. Average specific growth rate inhibitions were 0, 5, 0, 5, and 0%, respectively. The EC50 for area under the curve and average specific growth rate was determined to be >74.6 mg a.i./L.

         b. Definitive Study

Table 1:  Experimental Parameters
                                   Parameter
                                    Details
                                    Remarks

                                   Criteria
Acclimation period:

Culturing media and conditions:  (same as test or not)

Health:  (any mortality observed)
Green algae cultures were maintained in liquid culture which were used to inoculate the test media in the test vessels.

Further details provided in Appendix 1 pg 31-32 of the study report.

Not reported.

EPA recommends the algal inoculum used to initiate toxicity testing is from a liquid culture shown to be actively growing (i.e. capable of logarithmic growth within the test period) in at least two subcultures lasting 7 days each prior to the start of the definitive test. A culture should not be used if it is contaminated by fungi/other algae or if test algae were used in a previous test.

OECD recommends an amount of algae suitable for the inoculation of test cultures and incubated under the conditions of the test and used when still exponentially growing, normally after an incubation period of about 3 days. When the algal cultures contain deformed or abnormal cells, they must be discarded.
Test system
Static/static renewal

Renewal rate for static renewal

Static

N/A

EPA recommends a static exposure technique. Although semi-continuous algal culturing techniques are available, they have not been commonly employed in algal toxicity testing and their use is not recommended.
Incubation facility
Orbital incubator

Duration of the test
96 hours

EPA recommends 96 hours at a minimum.
OECD:  72 hours.
Test vessel
Material: (glass/stainless steel)
Size:
Fill volume:

Erlenmeyer conical glass flasks
250-mL
100-mL

EPA recommends 125-500 mL Erlenmeyer flasks and test solution volume <=50% of flask volume. Flasks may be covered with foam plugs (that are proven non-toxic), stainless steel caps, Shimadzu enclosures, glass caps or screw caps.

EPA recommends all test vessels and closures to be identical.

OECD recommends 250 ml conical flasks are suitable when the volume of the test solution is 100 ml or use a culturing apparatus.
Details of growth medium
Name:
pH at test initiation:
pH at test termination:
Chelator used:
Carbon source:
Salinity (for marine algae):

Algal culture medium (EC/AM)
7.9 (in the negative control)
10.2 (in the negative control) *
Na2EDTA·2H2O
NaHCO3
N/A
*The 96-hour pH in the negative control replicate without algae was 7.9.  Additional details found in Appendix 1 pg 31-32 of the study report.

EPA recommends an AAP medium with chelating agents (e.g. EDTA) prepared according to EPA's 850.4500 guideline (http://www2.epa.gov/test-guidelines-pesticides-and-toxic-substances/series-850-ecological-effects-test-guidelines).  Lower concentrations of chelating agents (down to one-third of the normal concentration recommended for AAP medium) may be used in the nutrient medium for test solution preparation if it is suspected that the chelator will interact with the test material.

EPA recommends adjustment of pH before adding inoculum, if pH of test solution is <5 or highly basic.

OECD recommends the medium pH after equilibration with air is ~8 with less than 0.001 mmol/L of chelator if used.
If non-standard nutrient medium was used, detailed composition provided (Yes/No)
N/A  -  standard medium used.

Dilution water used to prepare media
Source of dilution water:

Quality of dilution water
Hardness:
Alkalinity:
pH:
Specific conductivity:
Salinity (for marine algae):
Water pretreatment (if any):
TOC:
COD:
Particulate matter:
Metals:
Pesticides/PCBs:
Chlorine:

Deionized water

Not reported
Not reported
Not reported
Not reported
N/A
Not reported
Not reported
Not reported
Not reported
Not reported
Not reported
Not reported

Water used for preparation of nutrient medium should be of reagent quality (e.g., ASTM Type I water).

Marine algal nutrient medium is prepared by adding reagent grade chemicals to synthetic salt water or filtered natural salt water, or by preparing a complete saltwater medium. Salinity for saltwater medium should be 30 +- 5 %..
Indicate how the test material is added to the medium (added directly or used stock solution)
A primary stock solution was prepared at a nominal formulation concentration of 100 mg form/L by bringing 0.1002 g of test material to a final volume of 1 L with EC media. The stock solution was stirred for 30 minutes, and the remaining test media were prepared by serial dilution.

Aeration or agitation

Oscillation rate:
None

N/A

EPA recommends rotary shaking apparatus to oscillate vessels at approximately 100 cycles/min during the test. The rate of oscillation should be determined at test initiation or at least once daily during testing if the shaking rate changes. S. costatum should be shaken by hand 1-2X daily or shaken at 60 cycles/min.
Initial cell density
1.0 x 10[4] cells/mL

EPA recommends an initial population density of 10,000 cells/mL for P. subcapitata, S. costatum and at a minimum 10,000 cells/mL for all other test species. Other species may need a higher initial inoculum density and should be determined on a case-by case basis.

OECD recommends that the initial cell concentration be approximately 10,000 cells/ml for S. capricornutum and S. subspicatus. When other species are used the biomass should be comparable.
Number of replicates
Negative control:
Solvent control:
Treatments:

6
N/A
3

EPA recommends a minimum number of 4 replicates per treatment and control/ solvent control.

OECD preferably three replicates at each test concentration and ideally twice that number of controls. When a vehicle is used to solubilize the test substance, additional controls containing the vehicle at the highest concentration used in the test.

EPA recommends treatments be randomly assigned to test vessels, and test vessels randomly assigned to positions in the growth chamber.
Test concentrations
Nominal:

Geometric Mean-Measured:

Mean-Measured:

Initial

Formulation: 0 (control), 6.3, 12.5, 25, 50, and 100 mg form/L

Active ingredient: 0 (control), 4.70, 9.33, 18.7, 37.3, and 74.6 mg a.i./L

<0.003 (<LOD, control), 2.56, 6.42, 11.2, 31.2, and 60.7 mg a.i./L

<0.003 (<LOD, control), 2.57, 6.43, 11.3, 31.3, and 61.0 mg a.i./L

<0.003 (<LOD, control), 2.38, 6.73, 11.8, 29.7, and 66.6 mg a.i./L
Geometric mean-measured concentrations based on study author report. Mean-measured concentrations are reviewer calculated, refer to copy of Excel worksheet in Appendix I.
Both are based on the 0 and 96 hour measured concentrations.

EPA recommends at least 5 test concentrations, in geometric series with a ratio of 2 to 4, and insure bracketing the NOAEC or IC05 and the IC50, plus a control/solvent control.

OECD recommends at least five concentrations arranged in a geometric series, with the lowest concentration tested should have no observed effect on the growth of the algae. The highest concentration tested should inhibit growth by at least 50% relatively to the control and, preferably, stop growth completely.
Solvent (type, percentage, if used)
N/A
EPA recommends the solvent N,N-dimethyl-formamide. The concentration of solvent should be the same in all test treatments and should not exceed 0.1 mL/L.
Method and interval of analytical verification
Samples were collected at 0 and 96* hours and analyzed using high performance liquid chromatography analysis with UV detection (HPLC-UV) at 230 nm.

LOD: 0.003 mg/L
*Analysis at 96 hours included samples from replicates containing algae and replicates without algae.

EPA recommends confirmation of dissolved test concentrations at a minimum at test initiation and at test termination for static tests.
Test conditions
pH:
Temperature (media):
Temperature (air):
Photoperiod:
Light intensity and quality:

7.9 - 10.4
21.5 - 22.7°C
Not reported
Constant illumination
8030 - 8180 lux

EPA Recommendations
pH at test initiation: 7.5+-0.1 for freshwater and 8.0+-0.1 for marine.
Temperature for P. subcapita and N. pelliculosa is 24+-2 °C, and for S. costatum is 20+-2 [o]C
Photoperiod for P. subcapita and N. pelliculosa is continuous, and for S. costatum is 14 hr light/ 10 hr dark.
Light intensity: 60 μmol/m2/s or 4300 lux.

OECD recommended the temperature in the range of 21 to 25[o]C maintained at +- 2[o]C and continuous uniform illumination provided at approximately 8000 Lux measured with a spherical collector. OECD: pH is measured at beginning of the test and at 72 hours, it should not normally deviate by more than one unit during the test.

EPA recommends measuring pH at test initiation and at end of the test (or daily if pH adjustment was necessary); temperature on a separate vessel or hourly/daily on the air; and light intensity at test initiation (or daily if intensity changed by >15%);
Reference chemical (if used)
name:
concentrations:

N/A

Other parameters, if any
None

      2. Observations:

Table 2:  Observation parameters
                                  Parameters
                                    Details
                                    Remarks

                                   Criteria
Parameters measured including the growth inhibition/other toxicity symptoms
Cell density
Area Under the Curve
Average Specific Growth Rate

Recommended parameters measured per replicate include:
-Algal cell density (cell count/mL)
-yield (final population density)
-average specific growth rate
-mean area under growth curve (AUC)
Measurement technique for cell density and other end points
Cell concentrations were measured using a Z2 Coulter Counter (Coulter Electronics Ltd., Luton, UK). The starting cell concentration of the starter culture was determined using the Z2 Coulter Counter and confirmed using a haemocytometer.

Area under the curve:
A = ((N1-N0)/2)(t1)+((N1+N2-2N0)/2)(t2-t1)+((Nn-1+Nn-2N0)/2)(tn-tn-1)
Where:
A = Area under the Curve
N0 = initial measured cell concentration at time t0 (cells/mL)
N1 = measured cell concentration at time t1 (cells/mL)
Nn = measured cell concentration at time tn (cells/mL)
N2 = measured cell concentration at time t2 (cells/mL)
t1 = time of first measurement after the beginning of the test (h)
t2 = time of second measurement after the beginning of the test (h)
tn = time of nth measurement after the beginning of the test (h)

Growth Rate:
μ = (LogeNn - LogeN0) / tn
Where:
μ = average specific growth rate
N0 = initial measured cell concentration at time t0 (cells/mL)
Nn = measured cell concentration at time tn (cells/mL)
tn = time of nth measurement after the beginning of the test (h)

EPA recommends the measurement of cell counts by microscopic observation or electronic particle counter, with alternative option of measuring chlorophyll a.

OECD recommends the electronic particle counter, microscope with counting chamber, fluorimeter, spectrophotometer, and colorimeter. (note: in order to provide useful measurements at low cell concentrations when using a spectrophotometer, it may be necessary to use cuvettes with a light path of at least 4 cm).
Observation intervals
Every 24 hours

EPA and OECD: every 24 hours.
Other observations, if any
At the end of the exposure period, the control test media appeared as green cultures. In the mean-measured 2.57, 6.43, 11.3, and 31.3 mg a.i./L test solutions, the general appearance of the test media was as green cultures with small amounts of white particulate material on the base of the vessels, increasing in amount with concentration. In the 61.0 mg a.i./L test solutions, cultures appeared green with white particulate material on the base of the vessels. In flasks not inoculated with algae, the test media were unchanged relative to the appearance at the start of the test.

Indicate whether there was an exponential growth in the control
Cell density increased by a factor of 353X in the negative control.

During the 96 hour test period, cell counts in the controls did not increase by a factor of at least 100X for P. subcapitata and a factor of at least 30X for S. costatum (i.e., logarithmic growth in the controls was not reached during the test).

OECD: cell concentration in control cultures should have increased by a factor of at least 16 within three days.
Were raw data included?
Yes

II. RESULTS and DISCUSSION:

	A. INHIBITORY EFFECTS:

   For mean growth rate, the % inhibition in the exposure groups compared to the control were low (<= 6%) in all treatment groups. For cell density, the % inhibitions fluctuated across test concentrations but did demonstrate a general dose response. The largest inhibition was determined for the highest test level (29%). Area under the curve followed the same pattern as cell density, and the largest inhibition was determined in the highest test level (34%). Effects were dose responsive.

   At the start of the exposure period the control and lowest test concentration solutions appeared as clear solutions. The mean-measured 6.43 and 11.3 mg a.i./L test solutions were white homogeneous liquid dispersions, while the 31.3 and 61.0 mg a.i./L test solutions were white non-homogeneous liquid dispersions with particulate matter at the bottom of the test vessel in the highest test level.

   At the end of the exposure period, the control test media appeared as green cultures. In the mean-measured 2.57, 6.43, 11.3, and 31.3 mg a.i./L test solutions, the general appearance of the test media was as green cultures with small amounts of white particulate material on the base of the vessels, increasing in amount with concentration. In the 61.0 mg a.i./L test solutions, cultures appeared green with white particulate material on the base of the vessels. In flasks not inoculated with algae, the test media were unchanged relative to the appearance at the start of the test.

   There was a major change in pH over the study duration. In the control, pH increased from 7.9 at test initiation to 10.2 at test termination. In all treatment groups, the pH ranged from 8.0 to 8.1 at test initiation and ranged from 10.2 to 10.4 at 96 hours.

Table 3:  Effect of Dacthal W-75 [ai: chlorthal-dimethyl (Dacthal)] on growth of Green Algae, Pseudokirchneriella subcapitata (formerly Selenastrum capricornutum)
Treatment
Mean-measured
(and nominal),
mg a.i./L
                                 Initial cell
                          Density (x 10[4] cells/mL)
                              Cell density at[1]

                                   24 hours
                                   72 Hours
                                   96 hours

                                 cell density
                                % inhibition[1]
Negative control (<LOD)
                                      1.0
                                     3.57
                                      125
                                      353
                                      N/A
2.57 (4.70)
                                      1.0
                                     3.09
                                      109
                                      259
                                      27
6.43 (9.33)
                                      1.0
                                     3.12
                                      117
                                      327
                                       7
11.3 (18.7)
                                      1.0
                                     3.19
                                      109
                                      283
                                      20
31.3 (37.3)
                                      1.0
                                     3.07
                                     99.5
                                      297
                                      16
61.0 (74.6)
                                      1.0
                                     -6.12
                                     86.5
                                      251
                                      29
 1 Calculated by the reviewer.
  Data were obtained from Table 3 on page 25 of the study report.
  LOD was 0.003 mg a.i./L

Table 4:  Effect of Dacthal W-75 [ai: chlorthal-dimethyl (Dacthal)] on growth of Green Algae, Pseudokirchneriella subcapitata (formerly Selenastrum capricornutum)
Treatment
Mean-measured
(and nominal),
mg a.i./L
                                 Initial cell
                                    density
                              (x 10[4] cells/mL)
                               Mean growth rate
                                 (day[-1]) [1]
            Mean area under the curve (x 10[4] cells x days/mL) [1]

                                  0-96 Hours
                                % Inhibition[1]
                                  0-96 Hours
                                % Inhibition[1]
Negative Control (<LOD)
                                      1.0
                                     1.47
                                      N/A
                                      336
                                      N/A
2.57 (4.70)
                                      1.0
                                     1.39
                                       5
                                      268
                                      20
6.43 (9.33)
                                      1.0
                                     1.45
                                       1
                                      310
                                       8
11.3 (18.7)
                                      1.0
                                     1.41
                                       4
                                      280
                                      17
31.3 (37.3)
                                      1.0
                                     1.42
                                       3
                                      273
                                      19
61.0 (74.6)
                                      1.0
                                     1.38
                                       6
                                      222
                                      34
 1 Calculated by the reviewer.
  Data were obtained from Tables 3 & 4 on pages 25 & 26 of the study report.
  LOD was 0.003 mg a.i./L
Table 5:  Statistical endpoint values. {calculated by the study author based on geometric mean-measured (nominal) concentrations}
                             Statistical Endpoint
                                 Cell density
                                     Yield
                                  Growth Rate
Area under the curve
NOAEC
(mg a.i./L)
                                Not determined
                                Not determined
                              <2.56 (<4.70)
                             <2.56  (<4.70)
IC50/EC50 (mg a.i./L) (95% C.I.)
                                Not determined
                                Not determined
                              >60.7 (>74.6)
                              >60.7 (>74.6)
Reference chemical, if used
NOAEC
IC50/EC50
N/A

   B. REPORTED STATISTICS:

   The NOAEC values for growth rate and area under the curve were determined using ANOVA and Dunnett's test (α = 0.05). The 96-hour EC50 values could not be calculated due to a lack of significant (>= 50%) inhibition compared to the control. The toxicity values were therefore visually estimated to be greater than the highest test level. The study author's results are based on the geometric mean-measured concentrations.

	C. VERIFICATION OF STATISTICAL RESULTS:

   Statistical Method:  The reviewer analyzed yield, growth rate, and area under the curve using CETIS version <IP_ADDRESS> with database backend settings updated by EFED on 7/25/17. The mean-measured concentrations were used for analysis and reporting.

   The data were tested for normality and homogeneity of variance using Shapiro-Wilk's and Bartlett's test, respectively (α = 0.01). For all endpoints, the ANOVA assumptions were met. The growth rate data were determined to be non-monotonic and were analyzed using Dunnett's test. Area under the curve and yield were generally monotonic, so were analyzed using Williams' Multiple Comparison test. The IC05 values were calculated, where possible, using non-linear regression results. The IC05 values for yield, growth rate, and area under the curve were far lower than the lowest test level or were unreliable and the confidence interval was unreasonably large. Therefore, this endpoint was not considered a reliable regression endpoint for yield, growth rate, and area under the curve. The IC50 values were visually estimated to be greater than the highest test level due to highly extrapolated non-linear regression results and/or unreliable or undetermined confidence intervals.

   Yield
   IC05: Not calculable				95% C.I.:  N/A
   IC50: >61.0 mg a.i./L				95% C.I.:  N/A
   NOAEC: 6.43 mg a.i./L*
   LOAEC: 11.3 mg a.i./L

   Growth rate
   IC05: Not calculable				95% C.I.:  N/A
   IC50: >61.0 mg a.i./L				95% C.I.:  N/A
   NOAEC: 6.43 mg a.i./L*
   LOAEC: 11.3 mg a.i./L

   Area under the curve (AUC)
   IC05: Not calculable				95% C.I.:  N/A
   IC50: >61.0 mg a.i./L				95% C.I.:  N/A
   NOAEC: 6.43 mg a.i./L*
   LOAEC: 11.3 mg a.i./L
   *See reviewer's comments below

   Endpoint(s) Affected:  Yield, growth rate, and area under the curve
   Most Sensitive Endpoint:  Yield, growth rate, and area under the curve (AUC) (based on the NOAEC)

   D.  STUDY DEFICIENCIES:

   There were solubility issues as evidenced by the poor recoveries present at test initiation (three of the lowest test levels had recoveries <=72% of nominal) as well as the study author's visual observations of white homogeneous liquid dispersions (second and third test levels), white non-homogeneous liquid dispersions with particulate matter at the bottom of the test vessel (second to highest and highest test levels), and particulate matter at the bottom of the test vessel (highest test level only). OCSPP 850.1000 recommends pre-testing to determine the limit of solubility, to test with different solvents to aid dissolution, in addition to using sonication, centrifugation or filtration, or minor adjustments to environmental conditions in testing to improve solubility. However, the concentrations at 96-hours represented 83 to 116% of the initial-measured concentrations, which indicated that the concentrations were stable over the duration of the study, although there appears to be issues with solubility.

   The pH in the negative control increased by 2.3 units over the course of the test (7.9 to 10.2), and OECD guidance recommends that the pH of the control should not increase by more than 1.5 units during the study. Whereas OCSPP does not provide guidance for pH increases in the control. In all treatment groups, the pH ranged from 8.0 to 8.1 at test initiation and ranged from 10.2 to 10.4 at 96 hours. The increase in pH was likely due to high rates of algal growth reaching the capacity of the test system. This is supported by the 96-hour samples in test vessels without algal cells, which had measured pH values of only 7.9-8.1. Measurements were only taken at 0 and 96 hours and it is unclear if the effect in the highest test concentration are treatment related or if something else is going on within the test system.

   E.  REVIEWER'S COMMENTS:

   The reviewer's and the study author's determination of the level that constituted the NOAEC for growth rate and area under the curve (AUC) were not in agreement. The study author reported the NOAEC for growth rate and area under the curve (AUC) to be less than the lowest test concentrations.  However, the reviewer determined, that although there were effects at the lowest test level, they were not dose responsive, and could be discounted. Although for all test concentrations that were greater than the lowest test concentration, they were considered to be dose responsive, with a general monotonic trend. Therefore, the reviewer determined that a more reliable NOAEC would be 6.43 mg a.i./L for yield, growth rate, and area under the curve (AUC). The IC50 values were in agreement when considering the differences between the mean-measured concentrations (used by the reviewer, refer to copy of Excel worksheet in Appendix I) and the geometric mean-measured concentrations (used by the study author). However, the study author did not analyze yield, which was a significantly affected endpoint. The reviewer's results are presented in the Executive Summary and Conclusions sections of this DER.

The following OCSPP 850.4500 validity criterion may not have been met:

 It was not reported if treatments were randomly assigned to test vessels or if vessels were randomly assigned to positions in the growth chamber. Although based on the description of the study summary this was likely completed.

   There were solubility issues as evidenced by the poor recoveries present at test initiation (three of the lowest test levels had recoveries <=72% of nominal) as well as the study author's visual observations of white homogeneous liquid dispersions (second and third test levels), white non-homogeneous liquid dispersions with particulate matter at the bottom of the test vessel (second to highest and highest test levels), and particulate matter at the bottom of the test vessel (highest test level only). OCSPP 850.1000 recommends pre-testing to determine the limit of solubility, to test with different solvents to aid dissolution, in addition to using sonication, centrifugation or filtration, or minor adjustments to environmental conditions in testing to improve solubility. Measurements on pH were only taken at 0 and 96 hours, and over the course of the test, the pH in the negative control increased by 2.3 units (from 7.9 at test initiation to 10.2 at test termination). In all treatment groups, the pH ranged from 8.0 to 8.1 at test initiation and ranged from 10.2 to 10.4 at 96 hours. The increase in pH was likely due to high rates of algal growth reaching the capacity of the test system. This is supported by the 96-hour samples in test vessels without algal cells, which had measured pH values of only 7.9-8.1. Laboratory toxicity tests should be conducted in environmentally relevant conditions which may not be represented by the strongly basic water conditions present in the Day 4 algal samples. These conditions may have inhibited growth in the controls and lower treatment groups, resulting in potentially less sensitive endpoints than would have occurred had the pH stayed in environmentally-relevant ranges. Had pH measurements been taken more frequently (i.e., daily), there would be more certainty that the similar dose-responses (and consequent NOAEC and IC50 endpoints) observed in treatment groups at 24-hours and 72-hours, compared to the treatments at 96-hours, were not a result of inhibitions in control growth due to high pH.

The 96-hour %CV values in the control replicate for mean growth rate and yield were 1.58 and 8.88%, respectively, meeting the OCSPP guideline requirement of <15%, respectively, and the OECD guideline requirement for average specific growth rate of <=10%. The guideline requirement of 100x logarithmic growth in controls was reached during the tests (336 factor increase).

The in-life phase of the definitive test was conducted sometime between September 19, 2003 and October 28, 2003.

   F. CONCLUSIONS:

   This study is scientifically sound and is classified as supplemental and may be used for risk characterization. The observed inhibitions after the lowest test level were considered to be dose responsive, with a general monotonic trend. The yield, growth rate, and area under the curve (AUC) were significantly affected by the test material at all concentrations; however, the reviewer determined, that although there were effects at the lowest test level, they were not dose responsive, and could be discounted. Therefore, based on this the reviewer determined that the more reliable NOAEC was 6.43 mg a.i./L. There was a major change in pH over the study duration. In all treatment groups, the pH ranged from 8.0 to 8.1 at test initiation and ranged from 10.2 to 10.4 at 96 hours. In the control, pH increased from 7.9 at test initiation to 10.2 at test termination, resulting in an increase of 2.3 units in the negative control. The increase in pH was likely due to high rates of algal growth reaching the capacity of the test system. Had pH measurements been taken more frequently (i.e., daily), there would be more certainty that the similar dose-responses (and consequent NOAEC and IC50 endpoints) observed in treatment groups at 24-hours and 72-hours, compared to the treatments at 96-hours, were not a result of inhibitions in control growth due to high pH. No inhibitions reached 50% or greater and the IC50 was >61.0 mg a.i./L, and the most sensitive endpoints were yield, growth rate, and area under the curve (AUC) based on a NOAEC of 6.43 mg a.i./L and a LOAEC of 11.3 mg a.i./L.

III.  REFERENCES:

All references were standard guidelines or statistical methods.

APPENDIX I. Copy of Excel Worksheet with Measured Concentrations


[Federal Register Volume 88, Number 33 (Friday, February 17, 2023)]
[Notices]
[Page 10418]
[FR Doc No: 2023-03337]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-470, OMB Control No. 3235-0529]

Submission for OMB Review; Comment Request; Extension: Rule 17f-7

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 350l-3521) (``Paperwork Reduction Act''), the
Securities and Exchange Commission (the ``Commission'') has submitted
to the Office of Management and Budget (``OMB'') a request for
extension of the previously approved collections of information
discussed below.
    Rule 17f-7 (17 CFR 270.17f-7) permits a fund under certain
conditions to maintain its foreign assets with an eligible securities
depository, which has to meet minimum standards for a depository. The
fund or its investment adviser generally determines whether the
depository complies with those requirements based on information
provided by the fund's primary custodian (a bank that acts as global
custodian). The depository custody arrangement also must meet certain
conditions. The fund or its adviser must receive from the primary
custodian (or its agent) an initial risk analysis of the depository
arrangements, and the fund's contract with its primary custodian must
state that the custodian will monitor risks and promptly notify the
fund or its adviser of material changes in risks. The primary custodian
and other custodians also are required to agree to exercise at least
reasonable care, prudence, and diligence.
    The collection of information requirements in rule 17f-7 are
intended to provide workable standards that protect funds from the
risks of using foreign securities depositories while assigning
appropriate responsibilities to the fund's primary custodian and
investment adviser based on their capabilities. The requirement that
the foreign securities depository meet specified minimum standards is
intended to ensure that the depository is subject to basic safeguards
deemed appropriate for all depositories. The requirement that the fund
or its adviser must receive from the primary custodian (or its agent)
an initial risk analysis of the depository arrangements, and that the
fund's contract with its primary custodian must state that the
custodian will monitor risks and promptly notify the fund or its
adviser of material changes in risks, is intended to provide essential
information about custody risks to the fund's investment adviser as
necessary for it to approve the continued use of the depository. The
requirement that the primary custodian agree to exercise reasonable
care is intended to provide assurances that its services and the
information it provides will meet an appropriate standard of care.
    The staff estimates that each of approximately 1,445 investment
advisers \1\ will make an average of 8 responses annually under the
rule to address depository compliance with minimum requirements, any
indemnification or insurance arrangements, and reviews of risk analyses
or notifications.\2\ The staff estimates each response will take 6
hours, requiring a total of approximately 48 hours for each adviser.\3\
Thus, the total annual burden associated with these requirements of the
rule is approximately 69,360 hours.\4\
---------------------------------------------------------------------------

    \1\ From a review of the Form ADV filings and Form N-CEN
filings, respectively, as of December 31, 2021 and for filings
received through August 31, 2022, Commission staff estimated that
1,445 registered investment advisers managed or sponsored open-end
registered funds (including exchange-traded funds) and closed-end
registered funds.
    \2\ 1,445 advisers x 8 responses = 11,560 responses.
    \3\ 8 responses per adviser x 6 hours per response = 48 hours
per adviser.
    \4\ 1,445 advisers x 48 hours per adviser = 69,360 hours.
---------------------------------------------------------------------------

    In addition, based on public filings made with the Commission, we
calculate that there are approximately 38 global custodians that are
engaged to perform global custodial services to funds and thus subject
to the provisions of rule 17f-7.\5\ This estimate is based on
information that is publicly available on Form N-CEN filings.\6\ The
staff further estimates that during each year, each of approximately 38
global custodians will make an average of 4 responses to analyze
custody risks and provide notice of any material changes to custody
risk under the rule.\7\ The staff estimates that each response will
take 260 hours, requiring approximately 1,040 hours annually per global
custodian.\8\ Thus the total annual burden associated with this aspect
of the rule is approximately 39,520 hours.\9\ The staff estimates that
the total annual hour burden associated with all collection of
information requirements of the rule is therefore 108,880 hours.\10\
---------------------------------------------------------------------------

    \5\ We analyzed Form N-CEN filings for registrants as of
December 31, 2021 and based on these filings, we estimated the
number of global custodians that have been retained by funds and are
subject to the provisions of rule 17f-7 to be approximately 38.
    \6\ See Item C.12.a.vii.7 of Form N-CEN.
    \7\ 38 custodians x 4 responses = 152 responses.
    \8\ 260 hours per response x 4 responses per global custodian =
1,040 hours per global custodian.
    \9\ 38 global custodians x 1,040 hours per global custodian =
39,520 hours.
    \10\ 69,360 hours + 39,520 hours = 108,880 hours.
---------------------------------------------------------------------------

    The estimate of average burden hours is made solely for the
purposes of the Paperwork Reduction Act and is not derived from a
comprehensive or even a representative survey or study of the costs of
Commission rules and forms. Compliance with the collection of
information requirements of the rule is necessary to obtain the benefit
of relying on the rule's permission for funds to maintain their assets
in foreign custodians. The information provided under rule 17f-7 will
not be kept confidential. An agency may not conduct or sponsor, and a
person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number.
    The public may view background documentation for this information
collection at the following website: www.reginfo.gov. Find this
particular information collection by selecting ``Currently under 30-day
Review--Open for Public Comments'' or by using the search function.
Written comments and recommendations for the proposed information
collection should be sent within 30 days of publication of this notice
by March 20, 2023 to (i) [email protected] and
(ii) David Bottom, Director/Chief Information Officer, Securities and
Exchange Commission, c/o John Pezzullo, 100 F Street NE, Washington, DC
20549, or by sending an email to: [email protected].

    Dated: February 13, 2023.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-03337 Filed 2-16-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 174 (Monday, September 9, 2013)]
[Notices]
[Pages 55126-55128]
[FR Doc No: 2013-21816]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70303]

Order Exempting Broker-Dealers Participating in NYSE Arca, Inc.'s
Lead Market Maker Incentive Program From Section 11(d)(1) of the
Securities Exchange Act of 1934 and Rule 11d1-2 Thereunder

September 3, 2013.
    On June 6, 2013, the Securities and Exchange Commission
(``Commission'') approved a proposed rule change of NYSE Arca, Inc.
(``Exchange'' or ``NYSE Arca'') to adopt new NYSE Arca Equities Rule
8.800 (``Rule 8.800''). Rule 8.800 establishes an incentive program on
a pilot basis (``Incentive Program'') for Lead Market Makers (``LMMs'')
in certain exchange-traded products (``ETPs'').\1\ The Incentive
Program is designed to encourage market makers to take LMM assignments
in certain lower volume ETPs by offering an alternative fee structure
for those LMMs and ``LMM Payments'' that would be funded from the
Exchange's general revenues if the LMM meets or exceeds certain
performance standards set forth in Rule 8.800(c) that relate to the
LMM's quoting activity in the ETP. The costs of the Incentive Program
would be funded by charging participating issuers non-refundable
``Optional Incentive Fees'' which may be paid by sponsors on behalf of
the issuer.
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    \1\ Securities Exchange Act Release No. 69706 (June 6, 2013), 78
FR 35340 (June 12, 2013) (SR-NYSEArca-2013-34) (the ``Approval
Order''). The Approval Order contains a detailed description of the
Incentive Program. On March 21, 2013, the Exchange filed with the
Commission, pursuant to Section 19(b)(1) of the Securities Exchange
Act of 1934, as amended (``Act'' or ``Exchange Act'') and Rule 19b-4
thereunder, a proposed rule change to establish the Program. The
proposed rule change, as modified by Amendment No. 1 thereto, was
published for comment in the Federal Register on April 11, 2013.
Securities Exchange Act Release No. 69335 (Apr. 5, 2013), 78 FR
21681 (Apr. 11, 2013). The Approval Order grants approval of the
proposed rule change, as modified by Amendments No. 1 and 2.
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    Section 11(d)(1) of the Exchange Act \2\ generally prohibits a
broker-dealer from extending or maintaining credit, or arranging for
the extension or maintenance of credit, on shares of new issue
securities, if the broker-dealer participated in the distribution of
the new issue securities within the preceding 30 days. Shares of open-
end investment companies and unit investment trusts registered under
the Investment Company Act of 1940, such as exchange traded fund
(``ETF'') shares, are distributed in a continuous manner. Broker-
dealers that sell such securities are therefore participating in the
``distribution'' of a new issue for purposes of Section 11(d)(1).\3\
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    \2\ 15 U.S.C. 78k(d)(1).
    \3\ See, e.g., Exchange Act Release Nos. 6726 (Feb. 8, 1962), 27
FR 1415 (Feb. 15, 1962) and 21577 (Dec. 18, 1984), 49 FR 50174 (Dec.
27, 1984).
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    The Division of Trading and Markets, acting under delegated
authority, granted an exemption from Section 11(d)(1) and Rule 11d1-2
thereunder to broker-dealers that have entered into an agreement with
an ETF's distributor to place orders with the distributor to purchase
or redeem the ETF's shares (``Broker-Dealer APs'').\4\ The SIA
Exemption allows a Broker-Dealer AP to extend or maintain credit, or
arrange for the extension or maintenance of credit, to or for customers
on the shares of qualifying ETFs subject to the condition that neither
the Broker-Dealer AP, nor any natural person associated with the
Broker-Dealer AP, directly or indirectly (including through any
affiliate of the Broker-Dealer AP), receives from the fund complex any
payment, compensation, or other economic incentive to promote or sell
the shares of the ETF to persons outside the fund complex, other than
non-cash compensation permitted under NASD Rule 2830(l)(5)(A), (B), or
(C). This condition is intended to eliminate special incentives that
Broker-Dealer APs and their associated persons might otherwise have to
``push'' ETF shares.
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    \4\ See Letter from Catherine McGuire, Chief Counsel, Division
of Trading and Markets, Securities and Exchange Commission to
Securities Industry Association (Nov. 21, 2005) (``SIA Exemption'').
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    The Incentive Program will permit certain ETPs, including ETFs and
commodity-based exchange traded trusts, to voluntarily incur increased
listing fees payable to the Exchange. In turn, the Exchange will use a
portion of the fees to make LMM Payments to market makers that improve
the market quality of participating issuers'

securities.\5\ LMM Payments will be accrued solely for quoting activity
on the Exchange. Broker-dealers receiving the incentive payments would
not be in compliance with the compensation condition of the SIA
Exemption discussed above.\6\ Therefore, an LMM that is also a Broker-
Dealer AP for an ETF (or an associated person or an affiliate of a
Broker-Dealer AP) that receives the incentives will not be able to rely
on the SIA Exemption from Section 11(d)(1).\7\
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    \5\ Among other things, the Incentive Program requires LMMs to:
(1) Maintain continuous, two-sided trading interest where the price
of the bid (offer) interest is not more than a designated percentage
away from the then current NBBO; (2) maintain quotes or orders at
the NBBO or better (the ``Inside'') during the month during Core
Trading Hours in accordance with certain maximum width and minimum
depth thresholds based on daily share volume and share price, unless
the thresholds are otherwise met by quotes or orders of all market
participants across all markets trading the security; (3) maintain
quotes or orders on NYSE Arca at the NBBO that meet either a time-
at-the-Inside requirement or a size-setting NBBO requirement; and
(4) for at least 90% of the time when quotes may be entered during
Core Trading Hours each trading day, as averaged over the course of
a month, maintain (A) at least 2,500 shares of attributable,
displayed posted buy liquidity on the Exchange that is priced no
more than 2% away from the NBB for the particular ETP; and (B) at
least 2,500 shares of attributable, displayed posted offer liquidity
on the Exchange that is priced no more than 2% away from the NBO for
the particular ETP. If an LMM does not meet these quoting
requirements, it will not receive an LMM Payment, and an LMM that
does not meet or exceed these performance standards for any two of
the three months of a quarter or for five months during the pilot
period may lose its LMM status. Request Letter at 5.
    \6\ The incentive payments market makers may receive under Rule
8.800 are indirect payments from the fund complex to the market
maker and that those payments are compensation to promote or sell
the shares of the ETF.
    \7\ See Approval Order, supra note 1, at 31-33.
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    Thus, NYSE Arca has requested, on behalf of itself and those
broker-dealers that receive payments under the Incentive Program as
discussed in its letter, an exemption from the requirements of Section
11(d)(1) of the Exchange Act and Rule 11d1-2 thereunder.\8\
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    \8\ Letter from Janet McGinness, Senior Vice President and
Secretary, NYSE Euronext to David Blass, Chief Counsel, Division of
Trading and Markets, Securities and Exchange Commission (September
3, 2013) (``Request Letter''). The relief requested is similar to
the relief the Commission previously granted to NASDAQ Stock Market
LLC in connection with its pilot Market Quality Program. See
Exchange Act Release No. 69892 (June 28, 2013).
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    NYSE Arca maintains that a Broker-Dealer AP and a broker-dealer
that is not a Broker-Dealer AP in a particular ETF, but effects
transactions in shares of the ETF exclusively in the secondary market
(``Non-AP Broker-Dealer'') should be able to rely on the SIA Exemption,
notwithstanding the receipt of payments under the Incentive Program.
Among other things, the Exchange notes that the LMM Payment is provided
only to LMMs that meet or exceed market quality standards and that the
Incentive Program will not provide an incentive for LMMs to ``push''
the securities of participating issuers.\9\ Rather, the Exchange states
that the Incentive Program is intended to foster enhanced liquidity,
robust quoting activity, narrowed spreads, and reduced transaction
costs for investors in participating ETPs. NYSE Arca notes that the LMM
Payments are not attributable to LMMs executing transactions in
securities, but only for LMMs' two-sided quoting activity. The Exchange
also states that the disclosure provisions of the Incentive Program
will alert and educate investors about the program and the LMM
Payments.\10\
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    \9\ Congress adopted Section 11(d)(1) in response to concerns
about potential conflicts of interest faced by persons acting as
both brokers and dealers in the distribution of new issue
securities. In a House report accompanying the Exchange Act,
Congress noted:
    It is difficult to serve two masters. And it is particularly
difficult to give impartial advice to a client if the dealer-broker
has his own securities to sell, particularly when they are new
securities for which there is no ready market.
    H.R. Rep. No. 1383, 73d Cong., 2d Sess. 15 (1934). Congress
concluded that forcing the separation of brokers and dealers would
have led brokers to abandon their dealer business, impairing the
mechanism to distribute new securities. In lieu of this measure,
Congress required broker-dealers to disclose to customers the
capacity in which they were acting and adopted section 11(d)(1)
prohibiting broker-dealers from extending margin on new issue
securities in the distribution of which the broker-dealer had
participated. Id.
    \10\ Request Letter at 7. The Exchange notes that its new rules
are designed to provide comprehensive and accessible disclosure to
investors about the MQP Program through the Exchange's Web site or
the Web sites of the participating issuers. New Rules 8.800(b)(6)
and (7) require the Exchange to disclose on its Web site the
following information with respect to the operation of the Incentive
Program: (i) The ETPs participating in the Incentive Program and the
LMM assigned to each participating ETP; (ii) the date a particular
ETP begins participating or ceases participating in the Incentive
Program; (iii) the date the Exchange receives written notice of an
issuer's intent to withdraw its ETP from the Incentive Program, or
an LMM's intent to withdraw from its ETP assignment(s) in the
Incentive Program, and, in each case, the intended withdrawal date,
if provided; and (iv) the amount of the Optional Incentive Fee for
each ETP. The Exchange also will include on its Web site a fair and
balanced description of the Incentive Program, including a
description of the potential benefits and risks that may be
attendant with an ETP's participation in the program. An issuer of
an ETP that is approved to participate in the Incentive Program will
also be required to (i) issue a press release to the public when an
ETP commences or ceases participation in the Incentive Program, (ii)
post such press release on its Web site, and (iii) provide on its
Web site a hyperlink to the Exchange's Web page describing the
Incentive Program.
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    NYSE Arca also asserts that the Incentive Program's goal of
enhancing market quality is most likely to be accomplished if the
program attracts as many participating market makers as possible. In
the Exchange's view, eligible market makers may decline to participate
in the program if no exemption from Section 11(d)(1) and Rule 11d1-2 is
available, either because the market makers may already extend credit
to customers on the securities of participating issuers or because the
value to market makers of offering credit services to customers on such
securities may outweigh the value of participating in the Incentive
Program.\11\ The Commission recognizes that broker-dealers that have to
choose between participating in the Incentive Program and having the
ability to offer credit services to customers in reliance on the SIA
Exemption for business reasons may determine to continue to offer the
credit services and decline to participate in the Incentive Program. In
other words, the lack of an available exemption from Section 11(d)(1)
and Rule 11d1-2 thereunder could serve to reduce the number of market
makers in the Incentive Program.
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    \11\ Request Letter at 6.
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    The Commission finds that it is appropriate in the public interest,
and is consistent with the protection of investors, to grant a limited
exemption from Section 11(d)(1) of the Exchange Act and Rule 11d1-2
thereunder to Broker-Dealer APs and Non-AP Broker-Dealers that
participate in the Incentive Program. The Incentive Program is intended
to improve market quality by promoting enhanced liquidity, reduced
spreads, and reduced cost of investing in the securities of
participating issuers. The Commission believes that granting the
exemption will encourage a larger number of market makers to
participate in the Incentive Program and that a larger number of
participating market makers should create greater potential for the
market quality improvements the Incentive Program aims to achieve. The
Commission notes in particular that the Exchange will determine to pay
an LMM Payment only if an LMM maintains certain minimum quoting
standards.\12\ No portion of the LMM Payment is attributable to sales
of ETP securities and thus the LMM Payment should provide no direct
incentive for LMMs to promote the sale of ETP securities. Thus, the
Commission does not believe that the LMM Payment will provide the kind
of incentive for ``share-pushing'' with which Congress was concerned
when it enacted Section 11(d).\13\ Moreover, the required Web site

disclosures, discussed above,\14\ should also help LMMs' customers
understand the Program's effect on LMMs' incentives and thus will help
investors to make informed decisions in light of the additional
incentives LMMs may have in providing quotes for these securities.
---------------------------------------------------------------------------

    \12\ See note 5, supra.
    \13\ See note 9, supra.
    \14\ See note 10, supra.
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Conclusion

    It is therefore ordered, that Broker-Dealer APs and Non-AP Broker-
Dealers that participate in the Incentive Program, may rely on the SIA
Exemption pertaining to Section 11(d)(1) and Rule 11d1-2
thereunder,\15\ subject to the conditions provided in that exemption,
notwithstanding that Broker-Dealer APs and Non-AP Broker-Dealers may
receive LMM Payments for participating in the Incentive Program as
described in your request.
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    \15\ See note 4, supra.
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    This exemption will expire when the Incentive Program terminates,
and is subject to modification or revocation at any time the Commission
determines that such action is necessary or appropriate in furtherance
of the purposes of the Exchange Act.

    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)(62).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-21816 Filed 9-6-13; 8:45 am]
BILLING CODE 8011-01-P


Comment Info: =================

General Comment:To Whom It Concerns,

I am writing to request an extension of the 'Comment Period' on the FDA's proposed Tobacco Deeming rule found on the Federal Register as No. 2014-09491 and as 79 Fed. Reg. 23, 142.

I am requesting that the current 75 day period be extended an additional 105 days, for a total of 180 days.

There are quite a lot of issues to digest in these documents and I will need some time to compose an adequate response and feel that while and extended time to 180 days may be adequate to do this, that the 75 day period of time clearly is not.

I have strong concerns about the availability, access, and cost of e-cigarettes/vaporizers/eliquids when compared to normal cigarettes, and its alternatives, that are on the market now and in the foreseeable future. They also have made it possible for all 4 of my immediate adult family members to quit the use of smoking products, but I am deeply concerned with what this regulation will do to that if it is enacted as it stands. I need more information from both the FDA and the industry as to how this will impact consumers and why. This can only be done if we have the time to find the information and digest what it means.

 Just as I may be the only published member of my household on this subject, in so far as actually writing to you, I am sure there are many more that are similar, and in that light, these regulations affect more than just those who actually write in to you. It is my hope that you will consider that the community that are using these vaporizing products is much larger than the number who willingly contact you, and therefore the decisions you are making will have a much farther reaching implication for those who are out there using these vaporizing products than just the ones who are writing to you.

Thank you for your time and consideration in reading my request for the extension of time on the 'Comment Period' for these proposed regulations.

If you wish to contact me, please do so.

Sincerely, Colin M


[Federal Register Volume 78, Number 144 (Friday, July 26, 2013)]
[Proposed Rules]
[Pages 45112-45114]
[FR Doc No: 2013-18056]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2012-0767; FRL-9838-7]

Approval and Promulgation of Air Quality Implementation Plans;
Missouri; Reasonably Available Control Technology (RACT) for the 8-Hour
Ozone National Ambient Air Quality Standard (NAAQS)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve a State Implementation Plan (SIP)
revision submitted by the State of Missouri to EPA in a letter dated
May 4, 2012. The purpose of the SIP revision is to amend Missouri's
regulation for the Control of Volatile Organic Compounds (VOC) and meet
the requirement to adopt reasonably available control technology (RACT)
for sources covered by EPA's Control Technique Guidelines (CTG) for
Industrial Cleaning Solvents. We are proposing to approve this revision
because it satisfies the applicable requirements of the Clean Air Act
(CAA) with respect to RACT for the Missouri portion of the St. Louis
Metropolitan 1997 8-hour ozone nonattainment area.

DATES: Comments must be received on or before August 26, 2013.

ADDRESSES: Submit your comments identified by Docket ID No. EPA-R07-
OAR-2012-0767, by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Mail or Hand Delivery or Courier: Lachala Kemp, Air Planning and
Development Branch, Environmental Protection Agency Region 7, 11201
Renner Boulevard, Lenexa, Kansas 66219.
    Instructions: Direct your comments to Docket ID No. EPA-R07-OAR-
2012-0767. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or email. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an email comment directly to EPA without
going through www.regulations.gov, your email address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket. All documents in the electronic docket are listed in the
http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the U.S. Environmental
Protection Agency Region 7, 11201 Renner Boulevard, Lenexa, Kansas
66219, from 8 a.m. to 4:30 p.m., Monday through Friday, excluding
Federal holidays. EPA requests that you contact the person listed in
the FOR FURTHER INFORMATION CONTACT section to schedule your
inspection. The interested persons wanting to examine these documents
should make an appointment with the office at least 24 hours in
advance.

FOR FURTHER INFORMATION CONTACT: Ms. Lachala Kemp, Air Planning and
Development Branch, U.S. Environmental Protection Agency Region 7,
11201 Renner Boulevard, Lenexa, Kansas 66219; telephone number (913)
551-7214; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us,'' or
``our'' refer to EPA. This section provides additional information by
addressing the following questions:

Table of Contents

I. What action is EPA proposing?
II. Statutory and Regulatory Background
III. Summary of Missouri's SIP Revision
IV. EPA's Proposed Action
V. Statutory and Executive Order Reviews

I. What action is EPA proposing?

    EPA is proposing to approve a SIP revision submitted by the State
of Missouri to EPA on May 4, 2012. The purpose of this revision is to
control the emissions of VOCs, consistent with Control Techniques
Guidelines (CTGs) issued by EPA, and to satisfy the RACT requirements
of the CAA for the Missouri portion of the St. Louis metropolitan 1997
8-hour ozone nonattainment area. Specifically, the revision
incorporates an amendment to an existing SIP-approved Missouri
regulation 10 Code of State Regulations 10-5.455 to control emissions
from Industrial Solvent Cleaning Operations in the St. Louis
metropolitan area. The revision includes lowering the allowable
emissions threshold for VOCs released per day from the use, storage and
disposal of industrial cleaning solvents, and adds requirements for
facilities that exceed the applicability threshold. EPA is proposing to
approve this revision because the adoption by Missouri of this
regulation represents RACT control levels for CTGs issued by EPA after
2006. In addition, EPA is proposing to approve this revision because it
meets the requirements of the conditional approval the EPA issued on
January 10, 2012. See 77 FR 3144 (January 23, 2012).

II. Statutory and Regulatory Background

    CAA section 172(c)(1) requires that SIPs for nonattainment areas
``provide for the implementation of all reasonably available control
measures as expeditiously as practicable (including such reductions in
emissions from existing sources in the area as may be obtained through
the adoption, at a minimum, of reasonably available control technology)
and shall provide for attainment of the national primary ambient air
quality standards.'' The St. Louis metropolitan area--which includes
the counties of Franklin, Jefferson, St. Charles and St. Louis and the
city of St. Louis in Missouri--is currently designated as a moderate
nonattainment area under the 1997 8-hour ozone National Ambient Air
Quality Standard (NAAQS).\1\ For areas in moderate nonattainment with
the ozone NAAQS, section 182(b)(2) requires states to submit SIP
revisions to EPA that require sources of VOCs that are subject to a CTG
issued by EPA, and

all other major stationary sources,\2\ in the nonattainment area to
implement RACT.
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    \1\ The St. Louis metropolitan area was also recently designated
as a ``marginal'' nonattainment area for the 2008 ozone NAAQS.
    \2\ For a moderate nonattainment area, a major stationary source
is one which emits, or has the potential to emit, one hundred tons
per year or more of VOCs. See CAA section 302(j).
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    EPA has defined RACT as the lowest emissions limitation that a
particular source is capable of meeting by the application of control
technology that is reasonably available, considering technological and
economic feasibility. See 44 FR 53761 (September 17, 1979). EPA
provides states with guidance concerning what types of controls could
constitute RACT for certain source categories through the issuance of
CTGs. See 71 FR 58745, at 58747 (October 5, 2006).
    Section 183(e) of the CAA provides that EPA may issue a CTG in lieu
of a national regulation for categories of consumer or commercial
products where the Administrator determines that such guidance will be
substantially as effective as regulations in reducing VOC emissions in
ozone nonattainment areas.

III. Summary of Missouri's SIP Revision

    On January 10, 2012, EPA took final action to conditionally approve
a SIP revision submitted by the State of Missouri to EPA on January 17,
2007, with a supplemental revision submitted to EPA on June 1, 2011.
See 77 FR 3144 (January 23, 2012). As part of that action, EPA also
approved several VOC rules adopted by Missouri and submitted to EPA in
a letter dated August 16, 2011. All of these rules addressed VOC RACT
requirements for sources in categories for which EPA issued CTGs during
2006-2008. However, in August 2011, Missouri did not submit a RACT rule
for inclusion into the Missouri SIP to address one CTG: Solvent Cleanup
Operations. Based on Missouri's commitment to submit a rule for
inclusion into the SIP to address this remaining CTG by December 31,
2012, EPA conditionally approved the Missouri SIP revisions that
address the requirements of RACT.
    On May 4, 2012, the Missouri Department of Natural Resources (MDNR)
submitted to EPA a proposed SIP revision demonstrating compliance with
the RACT requirements set forth by the CAA under the 8-hour ozone
NAAQS. This submittal addressed source categories for Industrial
Cleaning Solvents, a new CTG issued by EPA on October 5, 2006, for
which states were required to address by October 5, 2007 (71 FR
58745).\3\
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    \3\ Under section 183(b), EPA is required to periodically review
and, as necessary, update CTGs.
---------------------------------------------------------------------------

    This revision will ensure that the requirements of this CTG will be
incorporated into the VOC RACT rules for the St. Louis moderate ozone
nonattainment area. EPA has reviewed this new VOC rule revision with
respect to the RACT requirements and the recommendations in the new CTG
and proposes to find that this revision meets RACT. Moreover, this rule
is designed to fulfill the requirements of EPA's conditional approval
of Missouri's VOC RACT SIP. A brief description of the VOC rule that is
proposed for approval in this action is provided below.

10 CSR 10-5.455 Control of Emissions From Industrial Solvent Cleaning
Operations

    This rule is intended to reduce the VOC emissions from industrial
cleaning operations that use organic solvents. The rule amendment
adopted by Missouri on April 28, 2011, and submitted to EPA for
inclusion into the Missouri SIP lowered the allowable emissions
threshold for volatile organic compounds released per day from the use,
storage and disposal of industrial cleaning solvents, and added
requirements for facilities that exceed the applicability threshold.
The rule amendment adopted by Missouri on February 2, 2012,
incorporated equipment cleaning work practices as a compliance option
for manufacturers of coatings, inks and resins. EPA believes that these
changes make the limits consistent with the recommendations in the
Federal CTG for this source category.
    As discussed above, EPA published a final rulemaking which approved
Missouri's submittal with respect to several other VOC rules to address
RACT requirements. See 77 FR 3144. Therefore, today's action only
addresses the Industrial Cleaning Solvents source category. This
proposal does not reopen any other aspect of Missouri's VOC RACT SIP.

IV. EPA's Proposed Action

    In today's action, EPA is proposing to approve a revision to
Missouri's VOC rule 10 CSR 10-5.455 into Missouri's SIP, as EPA
believes that this rule satisfies RACT for the Missouri portion of the
St. Louis nonattainment area for Industrial Cleaning Solvents. EPA also
believes that this rule satisfies the requirements of the conditional
approval of Missouri's VOC RACT SIP referenced above. This action, if
final, would mean that the Missouri SIP meets all of the applicable VOC
RACT requirements for St. Louis under section 182(b)(2) of the Act, as
they relate to the 1997 ozone NAAQS.

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
proposed action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is

not approved to apply in Indian country located in the State, and EPA
notes that it will not impose substantial direct costs on tribal
governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Reporting and
recordkeeping requirements, Volatile organic compounds.

    Dated: July 8, 2013.
Karl Brooks,
Regional Administrator, Region 7.
[FR Doc. 2013-18056 Filed 7-25-13; 8:45 am]
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