[Federal Register Volume 80, Number 74 (Friday, April 17, 2015)]
[Notices]
[Pages 21290-21292]
[FR Doc No: 2015-08793]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74716; File No. SR-EDGX-2015-17]

Self-Regulatory Organizations; EDGX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
the Content of the BATS One Feed Under Rule 13.8(b) To Include
Consolidated Volume for All Listed Equity Securities

April 13, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on April 1, 2015, EDGX Exchange, Inc. (the ``Exchange'' or
``EDGX'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The Exchange
has designated this proposal as a ``non-controversial'' proposed rule
change pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-
4(f)(6)(iii) thereunder,\4\ which renders it effective upon filing with
the Commission. 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.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6)(iii).
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange amend [sic] the content of the BATS One Feed under
Rule 13.8(b) to include consolidated volume for all listed equity
securities. The text of the proposed rule change is available at the
Exchange's Web site at www.batstrading.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 parts of such
statements.

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

1. Purpose
    The Exchange proposes to amend the content of the BATS One Feed
under Rule 13.8(b) to include consolidated volume for all listed equity
securities. The Commission recently approved a proposed rule change by
the Exchange to establish a new market data product called the BATS One
Feed.\5\ The BATS One Feed is a data feed that disseminates, on a real-
time basis, the aggregate best bid and offer (``BBO'') of all displayed
orders for securities traded on EDGX and its affiliated exchanges \6\
and for which the BATS Exchanges reports quotes under the Consolidated

Tape Association (``CTA'') Plan or the Nasdaq/UTP Plan.\7\
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    \5\ See Securities Exchange Act Release No. 73918 (December 23,
2014), 79 FR 78920 (December 31, 2014) (File Nos. SR-EDGX-2014-25;
SR-EDGA-2014-25; SR-BATS-2014-055; SR-BYX-2014-030) (Notice of
Amendments No. 2 and Order Granting Accelerated Approval to Proposed
Rule Changes, as Modified by Amendments Nos. 1 and 2, to Establish a
New Market Data Product called the BATS One Feed) (``BATS One
Approval Order'').
    \6\ EDGX's affiliated exchanges are the BATS Exchange, Inc.
(``BZX''), the BATS Y-Exchange, Inc. (``BYX''), and the EDGA
Exchange, Inc. (``EDGA'', together with EDGX, BZX, and BYX, the
``BATS Exchanges''). On January 31, 2014, Direct Edge Holdings LLC
(``DE Holdings''), the former parent company of the Exchange and
EDGA, completed its business combination with BATS Global Markets,
Inc., the parent company of BATS and BYX. See Securities Exchange
Act Release No. 71449 (January 30, 2014), 79 FR 6961 (February 5,
2014) (SR-EDGX-2013-43, SR-EDGA-2013-34). Upon completion of the
business combination, DE Holdings and BATS Global Markets, Inc. each
became intermediate holding companies, held under a single new
holding company. The new holding company, formerly named ``BATS
Global Markets Holdings, Inc.,'' changed its name to ``BATS Global
Markets, Inc.''
    \7\ The Exchange understands that each of the BATS Exchanges
will separately file substantially similar proposed rule changes
with the Commission to implement fees for the BATS One Feed.
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    The last sale information disseminated as part of the BATS One Feed
includes the price, size, time of execution, and individual BATS
Exchange on which the trade was executed. The last sale information
also includes the cumulative number of shares executed on all BATS
Exchanges for that trading day.\8\ The Exchange now proposes to expand
the last sale information to include consolidated volume for all listed
equity securities regardless of where the transaction was executed. The
Exchange would obtain the consolidated volume directly from the
securities information processors and then distribute in a manner
consistent with the requirements for redistributing such data as set
forth in the CTA Plan and Nasdaq UTP Plan.\9\
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    \8\ The BATS One Feed also contains optional functionality which
enables recipients to receive aggregated two-sided quotations from
the BATS Exchanges for up to five (5) price levels for all
securities that are traded on the BATS Exchanges in addition to the
BATS One Summary Feed (``BATS One Premium Feed''). For each price
level on one of the BATS Exchanges, the BATS One Premium Feed
includes a two-sided quote and the number of shares available to buy
and sell at that particular price level.
    \9\ See CTA Consolidated Volume Display Policy available at
https://www.ctaplan.com (dated March 2015). The CTA Consolidated
Volume Display Policy requires that, ``[i]f a Customer calculates
the CTA Consolidated Volume and displays that alongside last sale
prices or bid-asked quotes that are not consolidated prices or
quotes under the CTA Plan or the CQ Plan, then the Customer must
incorporate into its display the following statement: ``Realtime
quote and/or trade prices are not sourced from all markets.''
Customer must also assure that any person included in the
redistribution chain starting with the Customer conspicuously places
such a statement in any such display that it provides.'' Id.
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \10\ in general, and furthers the objectives of Section
6(b)(5) of the Act \11\ in particular, in that it is designed to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in facilitating transactions in
securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system and, in general, to
protect investors and the public interest. The Exchange also believes
that the proposed rule change is consistent with Section 11(A) of the
Act \12\ in that it supports (i) fair competition among brokers and
dealers, among exchange markets, and between exchange markets and
markets other than exchange markets and (ii) the availability to
brokers, dealers, and investors of information with respect to
quotations for and transactions in securities. Furthermore, the
proposed rule change is consistent with Rule 603 of Regulation NMS,\13\
which provides that any national securities exchange that distributes
information with respect to quotations for or transactions in an NMS
stock do so on terms that are not unreasonably discriminatory. In
adopting Regulation NMS, the Commission granted self-regulatory
organizations and broker-dealers increased authority and flexibility to
offer new and unique market data products to the public. It was
believed that this authority would expand the amount of data available
to consumers, and also spur innovation and competition for the
provision of market data.
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    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(5).
    \12\ 15 U.S.C. 78k-1.
    \13\ See 17 CFR 242.603.
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    The proposed rule change is designed to promote just and equitable
principles of trade and remove impediments to and perfect the mechanism
of a free and open market and a national market system by providing for
the broader dissemination of consolidated volume to investors. The
Exchange also believes this proposal is consistent with Section 6(b)(5)
of the Act because it protects investors and the public interest and
promotes just and equitable principles of trade by providing investors
with new options for receiving consolidated volume. The Exchange also
believes that the proposed rule change is reasonable because
consolidated volume is currently included in a competing market data
products offered by the NYSE and Nasdaq.\14\ Therefore, the Exchange
believes the proposed rule change removes impediments to and perfects
the mechanism of a free and open market and a national market system,
and, in general, protects investors and the public interest.
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    \14\ See Securities Exchange Act Release No. 73553 (November 6,
2014), 79 FR 67491 (November 13, 2014) (SR-NYSE-2014-40) (Notice of
Amendment No. 1 and Order Granting Accelerated Approval to a
Proposed Rule Change, as Modified by Amendment No. 1, To Establish
the NYSE Best Quote & Trades (``BQT'') Data Feed); http://www.nyxdata.com/Data-Products/NYSE-Best-Quote-and-Trades (last
visited May 27, 2014) (data feed providing unified view of BBO and
last sale information for the NYSE, NYSE Arca, and NYSE MKT) (``NYSE
BQT Approval Order''). See also Nasdaq Basic, http://www.nasdaqtrader.com/Trader.aspx?id=nasdaqbasic (last visited March
26, 2015) (data feed offering the BBO and Last Sale information for
all U.S. exchange-listed securities based on liquidity within the
Nasdaq market center, as well as trades reported to the FINRA/Nasdaq
Trade Reporting Facility (``TRF'')); and Nasdaq NLS Plus, http://www.nasdaqtrader.com/Trader.aspx?id=NLSplus (last visited July 8,
2014) (data feed providing last sale data as well as consolidated
volume from the following Nasdaq OMX markets for U.S. exchange-
listed securities: Nasdaq, FINRA/Nasdaq TRF, Nasdaq OMX BX, and
Nasdaq OMX PSX).
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    Lastly, the proposal would not permit unfair discrimination because
the consolidated volume will be available to all of the Exchange's
customers and market data vendors on an equivalent basis. In addition,
any customer that wishes to receive consolidated volume via a different
source will be able to do so.

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

    The Exchange does not believe that the proposal will impose any
burden on competition not necessary or appropriate in furtherance of
the purposes of the Act. The Exchange believes that the proposed rule
change will enhance competition because it would enable the Exchange to
include consolidated volume as part of the BATS One Feed, thereby
enabling it to better compete with similar market data products
currently offered by the NYSE and Nasdaq that include such volume.\15\
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    \15\ See id. (noting that NYSE BQT and NLS Plus carry
consolidated volume for all listed equities).
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    Finally, although the BATS Exchanges are the exclusive distributors
of the individual data feeds from which certain data elements would be
taken to create the BATS One Feed, the Exchange is not the exclusive
distributor of the consolidated volume that would be included in the
BATS One Feed. A vendor seeking to offer a similar product and include
consolidated volume would be able to do so on the same terms as the
Exchange from a cost perspective. As discussed in in the BATS One
Approval Order,\16\ any entity may separately purchase the individual
underlying products, and if they so choose, perform a similar
aggregation and consolidation function that the Exchange performs in
creating the BATS One Feed, and offer a data feed with the same
information included in the BATS One Feed to sell and distribute it to
its clients with no greater cost than the Exchange. Likewise, a
competing vendor could also receive consolidated volume from the
securities information processors and include it as part of their
product to be disseminated to their customers under the same terms and
policies provided to the Exchange.\17\ Therefore, the Exchange believes
the inclusion of

consolidated volume in the BATS One Feed would not impose any burden on
competition not necessary or appropriate in furtherance of the purposes
of the Act.
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    \16\ See BATS One Approval Order, supra note 5.
    \17\ See CTA Consolidated Volume Display Policy, supra note 9.
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

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

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

    Because the proposed rule change does not (i) significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate if consistent with the protection of investors
and the public interest, the proposed rule change has become effective
pursuant to Section 19(b)(3)(A) of the Act \18\ and Rule 19b-
4(f)(6)(iii) thereunder.\19\
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    \18\ 15 U.S.C. 78s(b)(3)(A).
    \19\ 17 CFR 240.19b-4(f)(6)(iii). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission.
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    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \20\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \21\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has asked the Commission to waive the 30-day operative delay so that
the proposal may become operative immediately upon filing. The Exchange
believes that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest because it would allow
the Exchange to timely offer investors a new option for receiving
consolidated volume information. The Exchange further notes that other
exchanges currently offer similar data products that include
consolidated volume.\22\ The Commission believes that waiving the 30-
day operative delay is consistent with the protection of investors and
the public interest. Therefore, the Commission hereby waives the
operative delay and designates the proposed rule change operative upon
filing.\23\
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    \20\ 17 CFR 240.19b-4(f)(6).
    \21\ 17 CFR 240.19b-4(f)(6)(iii).
    \22\ See supra note 14 (noting that NYSE BQT and NLS Plus carry
consolidated volume for all listed equities).
    \23\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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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 necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule 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_ADDRESS>Please include
File Number SR-EDGX-2015-17 on the subject line.

Paper Comments

     Send paper comments in triplicate to Brent J. Fields,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-EDGX-2015-17. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-EDGX-2015-17, and should be
submitted on or before May 8, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\24\
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    \24\ 17 CFR 200.30-3(a)(12).
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Brent J. Fields,
Secretary.
[FR Doc. 2015-08793 Filed 4-16-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: November 29, 2005 (Volume 70, Number 228)]
[Notices]
[Page 71542]
[DOCID:fr29no05-73]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1614-DR]

Massachusetts; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the Commonwealth of Massachusetts (FEMA-1614-DR), dated November
10, 2005, and related determinations.

DATES: Effective November 17, 2005.

FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Recovery Division, Federal
Emergency Management Agency, Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the Commonwealth of Massachusetts is hereby amended to include the
following area among those areas determined to have been adversely
affected by the catastrophe declared a major disaster by the President
in his declaration of November 10, 2005:

Worcester County for Public Assistance (already designated for
Individual Assistance.)

    (The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund Program; 97.032,
Crisis Counseling; 97.033, Disaster Legal Services Program; 97.034,
Disaster Unemployment Assistance (DUA); 97.046, Fire Management
Assistance; 97.048, Individuals and Households Housing; 97.049,
Individuals and Households Disaster Housing Operations; 97.050,
Individuals and Households Program--Other Needs; 97.036, Public
Assistance Grants; 97.039, Hazard Mitigation Grant Program.)

R. David Paulison,
Acting Director, Federal Emergency Management Agency.
[FR Doc. E5-6652 Filed 11-28-05; 8:45 am]

BILLING CODE 9110-10-P


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: Mindy Ondish<PHONE_NUMBER>

E. I. du Pont de Nemours and Company

2F8131

EPA has received a pesticide petition (2F8131) from E. I. DuPont de Nemours and Company, DuPont Crop Protection, 1007 Market Street, Wilmington, Delaware 19898, proposing pursuant to section 408 (d) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 346a (d), to amend 40 CFR Part 180.478 by establishing a tolerance for residues of the herbicide rimsulfuron: N-((4,6-dimethoxypyrimidin-2-yl) aminocarbonyl)-3-(ethylsulfonyl)-2-pyridinesulfonamide in or on the raw agricultural commodities sorghum grain, forage and stover at 0.01 ppm.

This summary was prepared by the petitioner. EPA has determined that the petition contains data or information regarding the elements set forth in Section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting the petition. Additional data may be needed before EPA rules in the petition.

A. Residue Chemistry

1. Plant metabolism.

The qualitative nature of the residues of rimsulfuron in plants is adequately understood; therefore no additional metabolism data are required to support the proposed tolerances on sorghum grain, forage and stover.

2. Analytical method.

Adequate analytical methodology, high-pressure liquid chromatography with ESI-MS/MS detection, is available for enforcement purposes.

3. Magnitude of residues.

Sorghum Grain, Forage and Stover:

The results from 13 trials show that all samples of sorghum grain, forage and stover were <0.01 ppm for rimsulfuron after a single application of 0.5 oz rimsulfuron a.i./A.

B. Toxicological Profile

1. Acute toxicity.

Technical rimsulfuron is considered acute toxicology category III based on overall results from several studies. This compound is considered acute toxicology category III for acute dermal toxicity and eye irritation and acute toxicity category IV for acute oral and inhalation toxicity and skin irritation. Technical rimsulfuron is not a dermal sensitizer.

2. Genotoxicty.

Technical rimsulfuron was negative for genotoxicity in batteries of in vitro and in vivo tests. These tests included the following: mutagenicity in bacterial (Ames test) and mammalian (CHO/HGPRT assay) cells; in vitro cytogenetics (chromosomal aberration in human lymphocytes); in vivo cytogenetics (bone marrow micronucleus assay in mice); and unscheduled DNA synthesis in rat primary hepatocytes.

3. Reproductive and developmental toxicity.

A two-generation reproduction study was conducted in rats with dietary technical rimsulfuron concentrations of 0, 50, 3,000 or 15,000 ppm. The study was negative for reproductive toxicity and there was no indication that offspring were more susceptible to rimsulfuron administration than parents. The NOEL was 3,000 ppm (or 165 to 264 mg/kg/day for P1 and F1 males and females and their offspring). This was based on the following effects at 15,000 ppm (830 to 1,316 mg/kg/day): lower food consumption and/or food efficiency in P1 males and females and F1 females; decreased mean body weights and/or body weight gain by P1 and F1 males and females; lower mean body weights and increased incidence of small body size for F2 pups during lactation.

A developmental study was conducted in rats administered technical rimsulfuron by gavage at 0, 200, 700, 2,000 or 6,000 mg/kg/day. There were no systemic or developmental effects observed up to and including the highest dose tested. The NOEL was therefore > 6,000 mg/kg/day.      A developmental study was conducted in rabbits administered technical rimsulfuron by gavage at 0, 25, 170, 500 or 1,500 mg/kg/day. The NOELs for maternal and offspring toxicity were 170 and 500 mg/kg/day, respectively. The maternal NOEL was based on reduced body weight and mortality at higher doses. These maternal effects precluded any evaluation of adverse effects in fetuses at 1,500 mg/kg/day; however, there were no systemic or developmental effects observed among fetuses at 500 mg/kg/day and below.

4. Subchronic toxicity.

A 90-day study in mice was conducted at dietary concentrations of 0, 50, 375, 1,500 or 7,500 ppm. The NOELs were 375 ppm (56.0 mg/kg/day) for male mice and 7,500 ppm (1,575 mg/kg/day) for female mice. The NOEL for males was based on slight reductions in mean body weight gain and food efficiency at 1,500 ppm (228 mg/kg/day).

Technical rimsulfuron was administered in the diets of rats at 0, 50, 1,500, 7,500 or 20,000 ppm for 90 days. The NOEL was 1,500 ppm (102 and 120 mg/kg/day for males and females, respectively) based on reduced mean body weights and body weight gains and increased relative liver weights at 7,500 ppm (495 and 615 mg/kg/day for males and females, respectively).      Dogs were administered technical rimsulfuron in their diets at 0, 250, 5,000 or 20,000 ppm for 90 days. The NOEL was 250 ppm (9.63 and 10.6 mg/kg/day for males and females, respectively). This was based on slight increases in liver and/or kidney weights, increased urine volume and decreased urine osmolarity at 5,000 ppm (193 and 189 mg/kg/day for males and females, respectively).

5. Chronic toxicity.

An 18-month mouse study was conducted with dietary concentrations of 0, 25, 250, 2,500 or 7,500 ppm technical rimsulfuron. This product was not oncogenic in mice. The systemic NOEL was 2,500 ppm (351 and 488 mg/kg/day for males and females, respectively) based on decreased mean body weights in both sexes and increased incidence of spontaneous, age-related artery and tunica degeneration in the testes for this mouse strain at the highest dose tested, 7,500 ppm (1,127 and 1,505 mg/kg/day for males and females, respectively). The latter was observed in the absence of any effect on spermatogenesis. An increased incidence of dilation and cysts in the glandular stomach of males was also observed at 7,500 ppm.      A 2-year chronic toxicity/oncogenicity study was conducted in rats fed diets that contained 0, 25, 300, 3,000 or 10,000 ppm technical rimsulfuron. This product was not oncogenic in rats. The systemic NOELs were 300 ppm (11.8 mg/kg/day) for males and 3,000 ppm (163 mg/kg/day) for females. The NOELs were defined by decreased body weight gain and increased relative liver weights at 3,000 ppm (121 mg/kg/day) and 10,000 ppm (569 mg/kg/day) for males and females, respectively.      Technical rimsulfuron was administered for one year to dogs at dietary concentrations of 0, 50, 2,500 or 10,000 ppm. The NOELs were 50 ppm (1.6 mg/kg/day) for males and 2,500 ppm (86.5 mg/kg/day) for females. The NOEL for males was based on the following effects, which the Agency has previously determined were of questionable biological significance, observed at 2,500 ppm (81.8 mg/kg/day): increased absolute liver and kidney weights; and increased incidence of seminiferous tubule degeneration and increased numbers of spermatid giant cells present in the epididymides. The NOEL for females was based on the following effects observed at 10,000 ppm (358.5 mg/kg/day): decreased body weight and body weight gain; increased serum cholesterol levels and alkaline phosphatase activity, increased absolute liver weight and increased relative liver and kidney weights.

6. Animal metabolism.

The metabolism of rimsulfuron in animals (rat, goat and hen) is adequately understood and is similar among the species evaluated. Rimsulfuron was rapidly eliminated via urinary and fecal excretion in the rat. Approximately 60 to 70% of the administered dose to rats was excreted within 24 hours. There were no volatile metabolites detected and unmetabolised rimsulfuron was the major component in the urine (42 - 55%) and feces (5 - 16%). The major metabolic pathway in rats involved a contraction of the sulfonylurea bridge followed by dealkylation, hydroxylation and/or conjugation reactions. Cleavage of the sulfonylurea bridge was observed; however, it was considered to be a minor pathway. Elimination of administered rimsulfuron was similarly rapid for the goat and hen. Tissue residue levels were generally less than 0.3% of the administered dose for the rat, goat and hen. There was no evidence of accumulation of rimsulfuron or its metabolites in tissues of any of the species or in milk and eggs.

7. Metabolite toxicology.

There is no evidence that the metabolites of rimsulfuron, as identified in either the plant or animal metabolism studies, are of any toxicological significance.

8. Endocrine disruption.

No special studies investigating potential estrogenic or other endocrine effects of rimsulfuron have been conducted.  However, the standard battery of required toxicology studies has been completed. These include an evaluation of the potential effects on reproduction and development, and an evaluation of the pathology of the endocrine organs following repeated or long-term exposure to doses that far exceed likely human exposures.  Based on these studies there is no evidence to suggest that rimsulfuron has an adverse effect on the endocrine system.

C. Aggregate Exposure

1. Dietary exposure.

The residue of concern, as listed at 40 CFR 180.478, is parent rimsulfuron only.

No acute dietary risk assessment was needed since there is no acute tox endpoint.

The chronic reference dose (cRfD) of 0.818 mg/kg/day is based on the NOEL of 81.8 mg/kg/day from a one-year beagle dog tox study and a 100X safety factor.

a. Food.      i. Acute

For the general U.S. population, acute dietary exposure assessments were not considered relevant for rimsulfuron for the following reasons: rimsulfuron presents very low acute toxicity based on animal testing; and no detectable residues have been demonstrated in edible portions of treated crops.

ii. Chronic

There is no population in the chronic risk assessment for rimsulfuron, either dietary (food only) or aggregate (food and water), with an exposure greater than 0.1% of the chronic reference dose.

b. Drinking water.

Chronic drinking water exposure analyses were calculated for rimsulfuron using EPA screening concentration models for ground water SCI-GROW and surface water FIRST.  Results indicate that a reasonable certainty exists that rimsulfuron residues in drinking water will not contribute significantly to the aggregate human risk.

The predicted chronic concentration for rimsulfuron maximum surface water value was 0.74 ppb, and a maximum ground water value was 0.0522 ppb.  When the surface water concentration was included in the chronic dietary risk assessment, no population including the general U.S. population and all subpopulations had an exposure greater  0.1% of the chronic reference dose (cRfD), indicating a significant margin of safety.

No acute dietary endpoint was identified. Therefore, an acute drinking water risk assessment is not considered necessary. One can conclude with reasonable certainty that residues of Rimsulfuron in drinking water do not contribute significantly to the aggregate acute human health risk.

2. Non-dietary exposure.

Rimsulfuron is not registered for any uses that could result in non-occupational, non-dietary exposure to the general population.

D. Cumulative Effects

Rimsulfuron belongs to the sulfonylurea class of crop protection chemicals. Other structurally similar compounds in this class are registered herbicides. However, the herbicidal activity of sulfonylureas is due to the inhibition of acetolactate synthase (ALS), an enzyme found only in plants. This enzyme is part of the biosynthesis pathway leading to the formation of branched chain amino acids. Animals lack ALS and this biosynthetic pathway. This lack of ALS contributes to the relatively low toxicity of sulfonylurea herbicides in animals. There is no reliable information that would indicate or suggest that rimsulfuron has any toxic effects on mammals that would be cumulative with those of any other chemical.

E. Safety Determination

1. U.S. population.

Based on the completeness and reliability of the toxicology database and using the conservative assumptions presented earlier, EPA has established a chronic RfD of 0.818 mg/kg/day. This RfD is based on the systemic NOEL of 81.8 mg/kg/day for males in a 1-year toxicity study in beagle dogs. It has been concluded that the aggregate exposure for existing crops plus the tolerances being proposed would utilize less than 0.1% of the RfD. Generally, exposures below 100% of the RfD are of no concern because it represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risk to human health. Thus, there is reasonable certainty that no harm will result from aggregate exposures to rimsulfuron residues.

2. Infants and children.

In assessing the potential for additional sensitivity of infants and children to residues of rimsulfuron, data from the previously discussed developmental and multigeneration reproductive toxicity studies were considered.

Developmental studies are designed to evaluate adverse effects on the developing organism resulting from pesticide exposure during pre-natal development. Reproduction studies provide information relating to reproductive and other effects on adults and offspring from pre-natal and post-natal exposures to the pesticide. The studies with rimsulfuron demonstrated no evidence of developmental toxicity at exposures below those causing maternal toxicity. This indicates that developing animals are not more sensitive to the effects of rimsulfuron administration than adults.      FFDCA section 408 provides that EPA may apply an additional uncertainty factor for infants and children in the case of threshold effects to account for pre- and post-natal toxicity and the completeness of the database. Based on current toxicological data requirements, the database for rimsulfuron relative to pre- and post-natal effects for children is complete. In addition, the NOEL upon which the RfD is based is much lower than the NOELs defined in the reproduction and developmental toxicology studies.

Conservative assumptions utilized to estimate aggregate dietary exposures of infants and children to rimsulfuron demonstrated that less than 0.1% of the RfD would be utilized for the highest exposed group, Children 1-2 years old.

Based on these conservative analyses, there is reasonable certainty that no harm will result to infants and children from aggregate exposures to rimsulfuron.

F. International Tolerances

A number of international tolerances (or Maximum Residue Levels, MRL's) have been established for rimsulfuron including the following:

                                   Countries                                      Crop                                  Tolerance/MRL Austria, Italy                                      Corn                                     0.1 ppm Austria, Italy, Canada                                    Potatoes                                     0.1 ppm Belgium, Denmark, Germany, Spain                                    Potatoes                                    0.05 ppm Germany, Spain, Portugal, Canada                                    Tomatoes                                    0.05 ppm


From:
Kiechle, Fredric S<EMAIL_ADDRESS>Sent:
Thursday, August 4, 2016 2:28 PM
To:
Jones, DonnaLee<EMAIL_ADDRESS>Raymond, Gabrielle<EMAIL_ADDRESS>Cc:
May, Jeffrey X<EMAIL_ADDRESS>Zavoda, Rich<EMAIL_ADDRESS>Hill, John R<EMAIL_ADDRESS>Subject:
Coke MACT ICR submittal, ArcelorMittal Burns Harbor LLC sections I-III attachments only, email #2-15

Dr. Jones, find attached in email #2-15 ICR requested reports for Q2 2015.

F. Scott Kiechle  Sr. Engineer-Environmental
ArcelorMittal Burns Harbor
Maintenance, Environmental & Utilities | 250 W. U.S. Highway 12 Burns Harbor, IN 46304-9745
T +219 787 4968 | F +219 787 4973  | M +219 313 2661  | www.arcelormittal.c
 Qapla'!

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