[Federal Register Volume 79, Number 43 (Wednesday, March 5, 2014)]
[Notices]
[Pages 12535-12538]
[FR Doc No: 2014-04793]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-71624; File No. SR-BX-2014-005]

Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Relating to
the Establishment of Fees for New Optional Means for Clients To Receive
BX TotalView ITCH Market Data

February 27, 2014.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on February 14, 2014, NASDAQ OMX BX, Inc. (``BX'' or ``Exchange'')
filed with the Securities and Exchange Commission (``SEC'' or
``Commission'') the proposed rule change as described in Items I and II
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 establish fees for new optional means for
clients to receive BX TotalView ITCH market data. Specifically, BX
proposes to offer remote Multi-cast ITCH Wave Ports for clients co-
located at third party data centers, through which BX TotalView

ITCH market data will be distributed after delivery to those data
centers via wireless network. BX is not offering a new market data
product.
    The text of the proposed rule change is below; proposed new
language is in italics.
* * * * *
    7015. Access Services.
    The following charges are assessed by the Exchange for ports to
establish connectivity to the NASDAQ OMX BX Equities Market, as well as
ports to receive data from the NASDAQ OMX BX Equities Market:
     $500 per month for each port pair, other than Multicast
ITCH[supreg] data feed pairs, for which the fee is $1000 per month, and
TCP ITCH data feed pairs, for which the fee is $750 per month for each
port pair.
     Internet Ports: An additional $200 per month for each
Internet port that requires additional bandwidth.
     Remote Multicast ITCH Wave Ports: $2,500 for installation
and then $5,000 per month. These fees are subject to a 30-day testing
period during which otherwise applicable fees are waived, and a one-
year minimum purchase period.
     TradeInfo BX is available to Members for a fee of $95 per
user per month.
* * * * *

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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange is proposing to amend BX Rule 7015 to establish fees
for remote Multi-cast ITCH Wave Ports for clients co-located at third-
party data centers, through which BX TotalView ITCH market data will be
distributed after delivery to those data centers via a wireless
network.
    Wireless technology has been in existence for many years, used
primarily by the defense, retail and telecommunications industries.
Wireless connectivity involves the beaming of signals through the air
between towers that are within sight of one another. Because the
signals travel a straight, unimpeded line, and because light waves
travel faster through air than through glass (fiber optics), message
latency is reduced. The continued use of this technology by the defense
industry and regulation of the spectrum by the FCC demonstrates the
secure nature of wireless networks.
    During the last few years, wireless technology has been introduced
in the financial services industry. In offering optional wireless
connectivity via a vendor-supplied network, BX is responding to
requests from clients that wish to utilize the technology.
    Remote Multi-cast ITCH (MITCH) Wave Ports. BX proposes to offer
remote Multi-cast ITCH Wave Ports for clients co-located at third-party
data centers. BX TotalView ITCH market data will be delivered to
Exchange owned cabinets at those data centers via a wireless network.
Clients will have the option of cross-connecting to the MITCH Wave
Ports in those data centers to receive the raw BX Multi-cast data feed,
TotalView ITCH. An installation charge for the remote port would be, at
each of the locations, $2,500 for installation, and $5,000 as a monthly
recurring fee. This offering, which is entirely optional, will enable
delivery of BX TotalView ITCH to the third-party data centers at the
same low latency.\3\ Clients opting to pay for the remote MITCH Wave
Ports will continue to be fee liable for the applicable market data
fees as described in BX Rule 7034.
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    \3\ BX cannot preclude minor latency variances in delivery of BX
TotalView in the third-party data centers to individual clients
because it does not control the cross-connects in those centers;
however, the microwave connectivity will provide the same latency to
all clients' MITCH Wave Ports and offers an improvement in latency
over fiber optic network connectivity.
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    This filing is similar to changes proposed to NASDAQ Rule 7015.\4\
The only differences are that the market data that will be delivered to
these remote MITCH Wave Ports is BX TotalView instead of NASDAQ
TotalView, and the monthly recurring fee is lower ($5,000 instead of
$7,500) due to the network bandwidth requirements for BX TotalView
being less than that for NASDAQ TotalView.
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    \4\ See Exchange Act Release No. 68735 (January 25, 2013); 78 FR
6842 (January 31, 2013) (order approving SR-NASDAQ-2012-119).
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    BX will utilize a network vendor to supply wireless connectivity
from the Carteret data center to the Secaucus Equinix data center (NY4)
used by Direct Edge and other exchanges, and the Weehawken Savvis data
center (NJ2) used by BATS and other ATS's. The vendor has installed,
tested and will maintain the necessary communication equipment for this
wireless network between the data centers.
    BX is offering this particular equity feed because this feed was
requested by clients. There is limited bandwidth available on the
wireless connection, and the Exchange has opted to offer those that are
in most demand to start. Additional feeds may be added based on overall
client demand and bandwidth availability.
    The wireless connectivity will be an optional offering, an
alternative to fiber optic network connectivity, and will provide lower
latency. It will not provide a new market data product, but merely an
alternative means of connectivity.
    Clients will place orders for the wireless connectivity via the
CoLo Console \5\ and would be subject to a one-year minimum lock-in
period. The lock-in feature, which is common practice for co-location
offerings, will ensure that the Exchange can recoup the substantial
investment required to establish the wireless system. As an incentive
to clients, BX will waive the first month's MRC. Clients will continue
to be charged by BX for the market data received. No changes in these
charges will occur as a result of this proposed offering.
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    \5\ The ``CoLo Console'' is a web-based ordering tool BX offers
to enable members to place co-location orders.
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    BX will perform substantial network testing prior to offering the
service for a fee to members. After this ``beta'' testing period, upon
initial roll-out of the service, clients will be offered the service
for a fee, and on a rolling basis, the Exchange will enable new clients
to receive the feed(s) for a minimum of 30 days before incurring any
monthly recurring fees. The wireless network will continue to be
closely monitored and the clients informed of any issues. Similar to
receiving market data over fiber optic networks, the wireless network
can encounter delays or outages due to equipment issues. As wireless
networks may be affected by severe weather events, clients will be
expected to have redundant methods to receive this market data and will
be asked to attest to having alternate methods or establishing an
alternate method in the near future when they order this service from
the Exchange.
    This new data feed delivery option will be available to all clients
of the data centers, and is in response to industry

demand, as well as to changes in the technology for distributing market
data. Clients opting not to pay for the wireless connectivity will
still be able to receive market data via fiber optics and standard
telecommunications connections, as they do currently, and under the
same fees. Receipt of trade data via wireless technology is completely
optional. In addition, clients can choose to receive market data via
other third-party vendors (Extranets or Telecommunication vendors) via
fiber optic networks or wireless networks.
    Competition for market data distribution is considerable and the
Exchange believes that this proposal clearly evidences such
competition. The Exchange is offering a new wireless connectivity
option and remote wave ports to keep pace with changes in the industry
and evolving customer needs as new technologies emerge and products
continue to develop and change. They are incremental to existing
offerings, entirely optional, and are geared towards attracting new
customers, as well as retaining existing customers.
    The proposed fees are based on the cost to BX of installing and
maintaining the wireless connectivity imposed by the vendor and the
Exchange and on the value provided to the customer, which receives low
latency delivery of the data feed. The costs associated with the
wireless connectivity system are incrementally higher than fiber
optics-based solutions due to the expense of the wireless equipment,
cost of installation, and testing. The fees also allow BX to make a
profit, and reflect the premium received by the clients in terms of
lower latency over the fiber optics option. Clients can choose to build
and maintain their own wireless networks or choose their own third
party network vendors but the upfront and ongoing costs will be much
more substantial than this Exchange wireless offering.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \6\ in general, and with Sections 6(b)(4) and (b)(5) of
the Act,\7\ 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 or system which the
Exchange operates or controls, and is designed to promote just and
equitable principles of trade, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general to protect investors and the public interest.
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    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(4) and (5).
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    The Exchange operates in a highly competitive market in which
exchanges offer co-location services as a means to facilitate the
trading activities of those members who believe that co-location
enhances the efficiency of their trading. Accordingly, fees charged for
co-location services are constrained by the active competition for the
order flow of such members.
    A co-location customer may obtain a similar service by contracting
with a wireless service provider to install the required dishes on
towers near the data centers and pay the service provider to maintain
the service. However, the cost involved in establishing service in this
manner is substantial and could result in uneven access to wireless
connectivity. The Exchange's proposed fees will allow these clients to
utilize wireless connectivity and obtain the lower latency transmission
of data from BX that is available to others, at a reasonable cost.
    Moreover, the Exchange believes the proposed fees for wireless
connectivity to BX market data are reasonable because they are based on
the Exchange's costs to cover hardware, installation, testing and
connection, as well expenses involved in maintaining and managing the
enhanced connection imposed by the vendor and the Exchange. The
proposed fees allow the Exchange to recoup these costs and make a
profit, while providing customers the ability to reduce latency in the
transmission of data from BX to third party data centers, and reduce
the cost to them that would be involved if they build or buy their own
wireless networks. The Exchange believes that the proposed fees are
reasonable in that they reflect the costs of the connection and the
benefit of the lower latency to clients.
    The Exchange believes the proposed wireless connectivity fee is
equitable and non-discriminatory in that all Exchange members that
voluntarily select this service option will be charged the same amount
for the same services. As is true of all co-location services, all co-
located clients have the option to select this voluntary connectivity
option, and there is no differentiation among customers with regard to
the fees charged for the service.
    The Exchange's proposal is also consistent with the requirement of
Section 6(b)(5) of the Act that Exchange rules be designed to promote
just and equitable principles of trade to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in regulating, clearing, settling, processing
information with respect to, and facilitating transactions in
securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest; and are not designed to
permit unfair discrimination between customers, issuers, brokers, or
dealers.
    The proposal is consistent with these requirements insomuch as it
makes available to market participants, at a reasonable fee and on a
non-discriminatory basis, access to low latency means of receiving
market data feeds.
    Initially, BX will perform substantial network testing prior to
making the service available to members. After this testing period, the
wireless network will continue to be closely monitored and maintained
by the vendor and the client will be informed of any issues.
Additionally, during the initial roll-out of the service and on a
rolling basis for future clients, the Exchange will enable clients to
test the receipt of the feed(s) for a minimum of 30 days before
incurring any monthly recurring fees. Similar to receiving market data
over fiber optic networks, the wireless network can encounter delays or
outages due to equipment issues. As wireless networks may be affected
by severe weather events, clients will be expected to have redundant
methods to receive this market data and will be asked to attest to
having alternate methods or establishing an alternate method in the
near future when they order this service from the Exchange.

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

    BX does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended. To the contrary,
this proposal will promote competition for distribution of market data
by offering an optional and innovative product enhancement. Wireless
technology has been in use for decades, is available from multiple
providers, and may be adopted by other exchanges that decide to offer
microwave connectivity for delivery of market data. As discussed above,
the Exchange believes that fees for co-location services, including
those proposed for microwave connectivity, are constrained by the
robust competition for order flow among

exchanges and non-exchange markets, because co-location exists to
advance that competition. Further, excessive fees for co-location
services, including for wireless technology, would serve to impair an
exchange's ability to compete for order flow rather than burdening
competition.

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

    Because the foregoing 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)
by its terms does not become operative for 30 days after the date of
this filing, 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 \8\ and Rule 19b-4(f)(6) \9\ thereunder.
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    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to provide the Commission
with written notice of its intent to file the proposed rule change,
along with a brief description and 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. The Exchange has met this requirement.
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    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative for 30 days after the date of filing. However,
Rule 19b-4(f)(6)(iii) 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 stated that the proposal will
promote competition for distribution of market data by offering an
optional and innovative product enhancement and is in response to
requests from clients that wish to utilize the technology. The
Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest so
that BX can immediately offer the remote Multi-cast ITCH Wave Ports to
clients that believe it can enhance the efficiency of their
trading.\10\ The Commission also notes that it approved a similar
Nasdaq offering for Nasdaq clients colocated at third party data
centers to receive Nasdaq TotalView ITCH market data.\11\ Accordingly,
the Commission hereby grants the Exchange's request and designates the
proposal operative upon filing.
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    \10\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
    \11\ See Exchange Act Release No. 68735 (January 25, 2013); 78
FR 6842 (January 31, 2013) (order approving SR-NASDAQ-2012-119).
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    At any time within 60 days of 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.

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-BX-2014-005 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-BX-2014-005. 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 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; 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-BX-2014-005, and should be
submitted on or before March 26, 2014.
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    \12\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-04793 Filed 3-4-14; 8:45 am]
BILLING CODE 8011-01-P


 Page 1 of 19 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES April 13, 2006 MEMORANDUM SUBJECT: Human Studies Review Board: Weight of Evidence Discussion for Methyl isothiocyanate ( MITC).

DP Barcode D293353 TXR No.: 0054209 PC Codes: 068103 FROM: Anna Lowit, Ph. D., Toxicologist Toxicology Branch Health Effects Division ( 7509C)

THROUGH: Louis Scarano, Branch Chief Toxicology Branch Health Effects Division ( 7509C)

TO: Tina Levine, Ph. D., Director Health Effects Division ( 7509C)

This document describes the scientific support for deriving a point of departure for methyl isothiocyanate ( MITC) using a human odor threshold and eye irritation study ( MRID no. 44400401). This point of departure is applicable for use in acute ( 1 day) risk assessments to by standers and occupational workers exposed to MITC in air. Page 2 of 19 I. Background and Introduction:

There are several pathways of exposure for methyl isothiocyanate ( MITC, see figure 1 for chemical structure). MITC can be used as a pesticide directly to treat wood poles. MITC is also a key degradate of several fumigant pesticides ( i. e., metam sodium, metam potassium and dazomet). Following application, metam sodium, metam potassium and dazomet break down quickly to a variety of degradates, including the major degradate, MITC. It is believed that MITC that provides the fumigating properties of the parent active ingredients. Metam sodium and metam potassium are used to treat sewage systems. Metam sodium, metam potassium, and dazomet are used as a soil fumigants. Soil fumigants are pesticides which, when injected or incorporated into soil, form a gas which permeates the soil and kills soil borne pests, such as insects, microorganisms, weeds, and nematodes. After the fumigant dissipates from the soil in a few days to a couple of weeks, planting can take place. Soil fumigants have the potential to move off site following field applications, resulting in exposure to bystanders near treated areas and to people far away from treated areas through ambient air. Use of the soil fumigants also results in exposure to those handling the pesticides or working in treated fields. Acute inhalation exposures to bystanders and workers appear to present the greatest risk concern. Based on pounds of active ingredient applied, metam sodium is the most widely used soil fumigant in the U. S and in 2001 was the 3rd most commonly used pesticide in the country. As such, due to the extensive use of metam sodium as a soil fumigant, the major pathway of exposure to MITC is acute inhalation exposure from the off gassing following metam sodium application.

Figure 1. Chemical structure of MITC.

The Agency is currently undertaking a systematic effort to evaluate the human health risks from exposure to soil fumigants. The public comment period of the Agency's preliminary risk assessments for metam sodium and MITC ended in October, 2005. The Agency's risk assessments for metam sodium, metam potassium, dazomet, and MITC have relied on the MITC eye irritation study as the basis for the point of departure ( PoD) for acute inhalation exposures to by standers and occupational workers from off gassing of MITC. The California Department of Pesticide Regulation ( CDPR) has also used this study in the CDPR human health risk assessment for exposure to MITC from metam sodium applications. In accordance with the human studies rule, the Agency is asking the Human Studies Review Board to review the scientific conduct and design of the eye irritation study and its potential utility in assessing human health risk. Page 3 of 19 II. Hazard Characterization and Database Summary The mode of toxic action for MITC is not known at this time. However, reactivity with biological nucleophiles such as sulfhydryl groups of glutathione or proteins has been proposed as the potential mode of action ( Valentine, et al., 1995). Consistent with this proposed mode of action, MITC is primarily an irritating compound that produces non specific systemic effects in oral toxicity studies such as changes in body weight, food consumption, and hematological parameters. Following air exposures to MITC, consistent effects are observed in rats and humans. For example, clinical signs and pathological changes of the respiratory tract consistent with an irritant have been observed in laboratory studies in rat. Humans exposed to MITC complain of symptoms such as itchy and burning eyes, rash and burning skin, nausea, scratchy throat, salivation, coughing, and shortness of breath. In acute toxicity testing with animals, MITC is considered Acute Toxicity Category I ( corrosive) for skin and eye irritation. MITC is also a skin sensitizer in guinea pigs.

A. Animal database The majority of animal studies available for metam sodium/ potassium, dazomet, and MITC are for oral exposure and are not considered relevant for assessing acute inhalation exposure for MITC. At the present time, the data base of acceptable animal inhalation toxicology studies for MITC is very limited. A 28 day inhalation study with MITC in rats ( MRID no. 45314802) is available. There are several acute lethality studies available with MITC. However, one acute inhalation lethality study ( MRID no 45919410) is considered the most reliable. There is also a 90 day inhalation study with MITC which is considered unacceptable due a variety of deficiencies including lack of nasal pathology and poor analytical data ( MRID no. 41221407). Executive summaries of the two subchronic studies are provided in Appendix 1.

There are no studies with laboratory animals available which specifically evaluate the dose response relationship and the continuum of potential acute, single day respiratory effects ( i. e., progression to more serious clinical outcomes) from exposure to MITC. Beginning on day 3 of exposure, observations of clinical signs of eyelid closure, somnolence, and ruffled fur were noted in the 28 day inhalation study in rat. Acute lethality studies are not designed to evaluate sub lethal dose response effects. At the lowest exposure concentration of 282 mg/ m3 ( approximately 80 ppm) in the acute lethality study, no mortality or gross pathological changes were observed but lung weights were increased and rales were noted on day one and reoccurred on day six post dosing.

B. Human information Epidemiological and incidence reporting data indicate that eye and respiratory irritation are common complaints among individuals exposed to MITC. Humans exposed to MITC complain of symptoms such as itchy and burning eyes, rash and burning skin, nausea, scratchy throat, salivation, and coughing. According to California EPA's Risk Characterization Document for MITC ( 2003), following a spill of metam sodium in the Sacramento River in 1991, of the 848 spill related hospital visits ( 705 separate individuals) in the month following the accident, 64% reported headache, 49% eye irritation, 42% throat irritation, 46% nausea, 30% dizziness, 27% shortness of breath, Page 4 of 19 25% diarrhea, 23% nasal irritation and 22% chest tightness. Measurements of MITC air levels in the area were not available for the first three days after the spill; modeling estimates of MITC air concentrations by CDPR and the Metam Sodium Task Force range significantly ( 3 ppm up to 4000 ppm) depending on the assumptions used in different modeling simulations. It is, therefore, not possible to correlate reported signs and symptoms with exposed air concentrations based on these data. Cone et al. ( 1994) performed a follow up study of 197 adults referred to health practitioners for evaluation of potentially spill related health problems. Thirty of these were considered positive for persistent effects including 10 who reported persistent exacerbation of asthma and met the criteria for reactive airways dysfunction syndrome ( RADS). An additional MITC drift incident occurred in the town of Earlimart, California in 1999; reported symptoms by individuals exposed were consistent with those in the Sacramento spill. Again, no air concentration measurements are available; modeling simulations with EPA's ISC model estimate that air concentrations of MITC ranged from 0.5 to 1 ppm ( O'Malley et al, 2004).

In order to evaluate human odor threshold and eye irritation produced by MITC vapors, human volunteers were exposed to air concentrations of MITC in a laboratory setting. A brief summary of this study is provided below.

Summary of the MITC eye irritation and odor threshold study :

In the olfactory threshold study, 33 individuals ( 16 males, 17 females) with a mean age of 25 years ( range, 18 to 34 years) were tested. They were exposed to three positive control odorants, pyridine, acetic acid, and n butyl alcohol as well as to MITC. The technician chose the odorant and concentration level. The odorant was dispensed in double blind fashion from one of three presentation ports. The subject was responsible for identifying from which of the presentation ports the odorant was dispersed. A 30 second rest period between exposures was permitted in order to allow the subject to recover prior to the next exposure. The operator tested each subject over the range of concentrations for each odorant until he was assured that the threshold had been adequately ascertained. A standard procedure was employed in order to make this determination. The observed odor threshold for MITC ranged from 0.2 to 8 ppm with a geometric mean of 1.7 ppm.

In the eye irritation study, seventy individuals ( 38 males, 32 females) with a mean age of 32 years ( range, 18 67 years; median age, 28 years) were exposed to air, MITC, and/ or acetic acid. Between 9 and 16 subjects were examined under each dose/ time period combination. Some individuals were tested for more than one exposure duration. The subject identification numbers were changed with each session and thus, the reader can not determine which subjects were included repeatedly. Sessions consisting of three exposure durations ( 14 minutes, 4 hours and 8 hours) were included. A range of MITC concentrations were used ( see Table 1). Page 5 of 19 An olfactometer which permitted the operator to dispense the test material through a manifold system was used. The test material could thus be diluted over a 100 fold concentration range. The olfactometer was modified by attaching goggles to the presentation line. This permitted the test material to be directed only to the eyes. Five parameters were used to ascertain an irritation response:

1. the subjects' subjective estimation of irritation ( using the " Likert" scale). Subjects marked the level of perceived irritation from ` no irritation' to ` so much that you feel you should end the exposure' with mid level similar to that for cutting up an onion; 2. photographs of the subjects' eyes prior to and after exposure; 3. blink rate as measured by electromyography; 4. effect upon visual acuity; 5. tear production.

Both a positive control ( acetic acid) and a negative control ( air) were employed. Baseline responses for each of the assessment parameters were determined under preexposure conditions (" zero time controls") and upon exposure to the negative control (" air only controls") for the prescribed period. A positive irritation response was based on three criteria: 1. the average response must be quantitatively greater than the preexposure response; 2. the average response must be greater than pre exposure and greater than could be expected statistically from individual to individual differences within the group; 3. the average treated response must be greater than the air only group's response and greater than could be expected from individual differences observed within the group.

In the eight hour test, subjective responses, blink rates and tearing were assessed at 0, 1.5, 3, 3.5, 6 and 8 hours ( tearing was not measured at 3.5 hours). Two 15 minute rest breaks and a 30 minute lunch break were permitted during the 8 hour period. In the four hour test, these same parameters were assessed at 0, 1, 2, 3 and 4 hours ( tearing was not measured at 0, 2 and 3 hours).

In the 14 minute exposure protocol, subjective responses and blink rates were measured at 0, 1, 4 and 14 minutes after the start of exposure. Tearing was measured at 14 minutes only. Visual acuity and ocular morphology were assessed at the beginning and end of each exposure period.

All analyses were performed in a double blind manner. Table 1 below provides the design for the study. Page 6 of 19 Table 1: Study design for the eye irritation human study with MITC.

Duration Dates Concentration( s) Tested Number of subjects Air only control 12 Acetic acid control 7 8 hour trial 12/ 8/ 94   1/ 9/ 95 0.22 ppm 16 Air only control 12 Acetic acid control 14 0.23 ppm 12 4 hour trial 3/ 13/ 95   3/ 31/ 95 0.8 ppm 9 Air only control 10 Acetic acid control 0 0.6 ppm 9 1.9 ppm 9 14 minute 4/ 18/ 95   4/ 26/ 95 3.3 ppm 9 Subjective ( Likert scale) responses. Exposure to 0.8 ppm ( 800 ppb) MITC resulted in a statistically significant positive response based on averaging the subjective assessments by the subjects using the Likert scale methodology ( Table 2). In that test, as many as 8 out of 9 subjects showed a positive response at 1 and 2 hours, the first two time points examined. ( Note: judgement of a positive response is itself somewhat subjective in light of the variability observed among control subjects.) Mean responses at those times, expressed as the percentage of the full Likert scale indicated by the subject, were 25% ± 14% and 26% ± 14%, respectively, compared to 2% ± 2% in zero time untreated controls ( a judgement of 50% was stated to be equivalent to the irritation one might expect from the cutting of a single mild onion). One hour and 2 hour air only controls exhibited responses of 6% ± 9% and 5% ± 8%, respectively. By 3 and 4 hours, all 9 subjects at 0.8 ppm appeared to respond positively, with mean responses of 39% ± 19% and 39% ± 26%, respectively. Air only controls at the latter 2 times were 5% ± 6% and 4% ± 6%, respectively.

Exposure to 0.22 ppm ( 220 ppb) did not result in a statistically significant mean Likert scale response when compared against air only controls. Despite the fact that statistical significance was achieved at 1 hour when compared against zero time controls ( 13% ± 15% vs. 4% ± 8% among zero time controls), the lack of statistical significance when compared against air only controls ( which registered 6% ± 9%) resulted in a judgement of no response. Page 7 of 19 Shorter exposures to 0.6 ppm ( 600 ppb) did not result in statistically significant Likert scale changes, though 1 of 9 individuals appeared to respond at 4 and 14 minutes. Exposure to 1.9 ppm ( 1900 ppb) or 3.3 ppm ( 3300 ppb) MITC for 4 or 14 minutes resulted in positive subjective responses at 4 and 14 minutes. At 1 minute of exposure, levels as high as 3.3 ppm did not evoke a statistically significant positive response.

Table 2. Mean perception of eye irritation ( Likert scale) data, human subjects Units: % of total line distance ( standard deviation)

4 hr trial Time points, hours 0 1 2 3 4 # subjects Air only control p value # 1a p value # 2b 1% ( 2%) n/ a n/ a 6% ( 9%) n/ a 0.08 5% ( 8%) n/ a 0.07 5% ( 6%) n/ a 0.02 4% ( 6%) n/ a 0.07 12 0.22 ppm p value # 1a p value # 2b 4% ( 8%) 0.21 n/ a 13% ( 15%) 0.16 0.02 8% ( 10%) 0.43 0.05 6% ( 8%) 0.55 0.16 6% ( 7%) 0.49 0.42 12 0.8 ppm p value # 1a p value # 2b 2% ( 2%) 0.57 n/ a 25% ( 14%)* 0.00 0.00 26% ( 14%)* 0.00 0.00 39% ( 19%)* 0.00 0.00 39% ( 26%)* 0.00 0.00 9 ap value # 1, t test against air only control subjects bp value # 2, t test against zero time values * Judged a positive irritation response. An irritation effect is considered to have been detected only if both statistical tests indicate significant differences and if mean is higher than the zero time mean.

8 hr trial Time points ( hours) 0 1.5 3 3.5 6 8 subjects Air only control p value # 1a p value # 2b 1% ( 1%) n/ a n/ a 9% ( 10%) n/ a 0.04 12%( 15%) n/ a 0.03 6% ( 10%) n/ a 0.16 15%( 19%) n/ a 0.03 8% ( 13%) n/ a 0.09 12 0.22 ppm p value # 1a p value # 2b 2% ( 2%) 0.23 n/ a 5% ( 4%) 0.18 0.01 5% ( 4%) 0.10 0.00 4% ( 4%) 0.44 0.24 8% ( 8%) 0.18 0.01 6% ( 5%) 0.46 0.00 16 0.8 ppm p value # 1a p value # 2b Not done n/ a ap value # 1, t test against air only control subjects bp value # 2, t test against zero time values Page 8 of 19 Eyeblink responses. Mean blink rate determinations at 0.8 ppm were statistically significantly increased at the 2 and 3 hour time points compared both to air only and zero time controls ( Table 3), with 7 of 9 subjects responding positively. Mean blinks per minute ( minus the zero time rate) were 16 ± 11 and 14 ± 13 at those times. Air only control rates at 2 and 3 hours were 3 ± 9 and 3 ± 8 blinks per minute, respectively. Statistical significance was not achieved at 1 and 4 hours, though a positive response was indicated in several individuals. The blink response to 0.6 ppm and 1.9 ppm at 1, 4 and 14 minutes did not indicate positivity. At 3.3 ppm, statistical significance was achieved at 4 and 14 minutes. A strong suggestion of a response was also present at 1 minute, though it was not statistically significant.

Table 3. Mean eyeblink data, human subjects Units: Blinks per minute minus zero time rate ( standard deviation)

4 hr trial Time points, hours 0 1 2 3 4 # subjects Air only control p value # 1a p value # 2b n/ a 3 ( 6) n/ a 0.13 3 ( 9) n/ a 0.24 3 ( 8) n/ a 0.23 3 ( 8) n/ a 0.18 12 0.22 ppm p value # 1a p value # 2b n/ a  5 ( 6) 0.00 0.02  2 ( 6) 0.13 0.35  5 ( 5) 0.01 0.01  3 ( 4) 0.03 0.04 12 0.8 ppm p value # 1a p value # 2b n/ a 7 ( 7) 0.15 0.00 16 ( 11)* 0.01 0.00 14 ( 13)* 0.03 0.01 12 ( 11) 0.052 0.01 9 ap value # 1, t test against air only control subjects bp value # 2, t test against zero time values * Judged a positive irritation response. An irritation effect is considered to have been detected only if both statistical tests indicate significant differences and if mean is higher than the zero time mean.

8 hr trial Time points ( hours) 0 1.5 3 3.5 6 8 # subjects Air only control p value # 1a p value # 2b n/ a  2 ( 7) n/ a 0.42  3 ( 7) n/ a 0.15  1 ( 5) n/ a 0.48  1 ( 7) n/ a 0.54 0 ( 7) n/ a 0.97 12 0.22 ppm p value # 1a p value # 2b n/ a  3 ( 6) 0.62 0.07  2 ( 5) 0.67 0.15  2 ( 5) 0.55 0.10  2 ( 4) 0.81 0.12  2 ( 5) 0.48 0.19 16 0.8 ppm p value # 1a p value # 2b Not done n/ a ap value # 1, t test against air only control subjects bp value # 2, t test against zero time values Page 9 of 19 Tearing, ocular morphology, and visual acuity. No statistically positive tearing responses were observed. However, 2 of 9 individuals exposed to 3.3 ppm MITC showed apparently positive responses at 14 minutes ( longer exposures were not evaluated at this concentration).

With respect to the possibility that there were changes in ocular morphology or visual acuity, the following passage is quoted from the study report ( page 39):

" Preliminary analysis of the photographs of test subjects' eyes indicated that no notable, exposure related changes were observable in the large majority of tests. In a few tests in which minimal increases in redness and swelling were observed, it appeared that they were more likely to occur in exposures to air than in exposures to MITC. A few individuals evinced a degree of mild edema at the highest level of MITC exposure, but this tended to be canceled out by other subjects who evinced some native edema and redness, pre exposure in the early morning. Changes in subjects' visual acuity were also few and apparently random. Accordingly the results of the photographic and acuity tests were not considered to provide any meaningful information on chemical exposure. Results from these tests are retained in study records."

Recovery. Rates of recovery from irritating MITC exposures were not evaluated directly. The comments of the test subjects indicated that recovery began immediately upon removal of the masks, and was complete within 20 minutes at the highest concentration tested, and sooner at lower concentrations. Page 10 of 19 Table 4. Summary of MITC eye irritation effects from human subjects Exposure time NOAEL ( ppm) LOAEL ( ppm) Source of observed Effect 1 minute 3.3

4 minutes 0.6 1.9 Subjective eye irritation 14 minutes 0.6 1.9 Subjective eye irritation 1 hour 0.23a 0.8 Subjective eye irritation 1.5 hours 0.22a

2 hours 0.23a 0.8 Subjective eye irritation and blink rate 3 hours 0.23a 0.8 Subjective eye irritation and blink rate 3.5 hours 0.22a

4 hours 0.23a 0.8 Subjective eye irritation 6 hours 0.22a

8 hours 0.22a

aThe slightly different values obtained at the low dose NOAEL level ( 0.22 and 0.23 ppm) reflected the fact that they were derived from tests performed on different days.

Conclusions from the eye irritation portion of the study include:

° For a one minute exposure, the NOAEL for eye irritation is 3.3 ppm due to a lack of response in any parameter tested.

° For exposures 4 14 minutes, the NOAEL for eye irritation is 0.6 ppm based on responses on the Likert subjective scale at 1.9 ppm.

° For exposures of 1 8 hours, based on the statistically significant subjective ( Likert scale) responses at 0.8 ppm MITC at 1 4 hours and the statistically significant eyeblink responses at 2 and 3 hours, 0.22 ppm was designated as the NOAEL for this study. Page 11 of 19 C. Point of Departure and Uncertainty Factor( s)

As stated above, there are no studies with laboratory animals available which specifically evaluate the dose response relationship and the continuum of potential acute, single day respiratory effects ( i. e., progression to more serious clinical outcomes) from exposure to MITC. In most cases, the Agency does not consider an acute lethality study as appropriate for deriving a PoD for assessing human health risk assessment. For purposes of characterization the Agency has evaluated the potential that the acute inhalation lethality study in rat could provide a PoD for acute risk assessment of MITC. If the lowest dose in the acute lethality study of 282 mg/ m3 is treated as an acute lowobserved adverse effect level ( LOAEL) and a typical LOAEL to NOAEL 10X factor is applied along with 100X for inter and intra species variation, then the final value would be 0.24 mg/ m3. The 1 8 hour NOAEL from the eye irritation study is 0.66 mg/ m3 ( 0.22 ppm). Using an intra species factor of 10X, the final regulatory value from the eye irritation study is 0.066 mg/ m3. Thus, in the case of MITC, use of the human eye irritation study provides a more sensitive endpoint for assessing acute human health risk to MITC.

Eye irritation is not an effect from inhalation exposure per se. However, eye irritation can result from exposures in the air. With respect to respiratory impairment, arguably, eye irritation is less severe compared to other possible effects associated with inhalation exposure to MITC, particularly given the expected reversible nature of the eye irritation effects at lower concentrations. Nonetheless, eye ( as well as nose and throat) irritation is uncomfortable and could potentially interfere with everyday tasks or activities. OPP notes that the Agency's Reference Concentration ( RfC) methodology ( 1994) includes eye, nasal, and throat irritation in the list of adverse effects albeit at the lower end of the hierarchal list which ranks effects from most to less severe. Due to the limitations in the existing inhalation toxicology database for MITC, the degree to which eye irritation predicts more serious outcomes is unclear. However, given that humans exposed to MITC complain of symptoms such as itchy and burning eyes in addition to rash and burning skin, nausea, scratchy throat, salivation, coughing, and shortness of breath, in the absence of more robust dose response data from acute exposures, eye irritation can be considered as a biomarker and surrogate for potential respiratory effects.

The MITC odor threshold and eye irritation study ( MRID 44400401) evaluated the dose response relationship for eye irritation at exposure durations ranging from 4 minutes to 8 hours. The results of the odor threshold study indicate that the eyes are likely to become irritated prior to detecting the odor; thus the odor threshold study has not be used for PoD derviation. The eye irritation study with MITC appears to have been scientifically well conducted with sensitive methods similar to those used by other laboratories ( Doty et al, 2004). The study provides a dose and time related response to MITC for the subjective scale and the blinking rate. Thus, the Agency has selected the human eye irritation study as the basis for the PoD in acute risk assessment to MITC in air. Page 12 of 19 The Agency has established the following PoDs for varying durations of exposure:

° For a one minute exposure, the NOAEL ( no observed adverse effect level) for eye irritation is 3.3 ppm due to a lack of response in any parameter tested.

° For exposures 4 14 minutes, the NOAEL for eye irritation is 0.6 ppm based on responses on the Likert subjective scale at 1.9 ppm.

° For exposures of 1 8 hours, based on the statistically significant subjective ( Likert scale) responses at 0.8 ppm MITC at 1 4 hours and the statistically significant eyeblink responses at 2 and 3 hours, 0.22 ppm was designated as the NOAEL.

For acute inhalation exposures to MITC, because a study using human subjects is being used, an interspecies factor is not necessary. A standard 10X was assigned for intraspecies variability.

III. Conclusions The general public may be exposed to fumigants, like MITC, in air following application because of their volatility since these chemicals can off gas into ambient air and can be transported off site by wind to non agricultural areas. The inhalation database for MITC for acute exposures is limited. The Agency has selected the human eye irritation study as the appropriate study for deriving a PoD for assessing acute risk to MITC. Page 13 of 19 References:

California Environmental Protection Agency, ( 2003) Risk Characterization Document for MITC. Department of Pesticide Regulation, California Environmental Protection Agency July 25, 2003.

Cone, J. E., L. Wugofski, J. R. Balmes, R. Das, R. Bowler, G. Alexeeff and D. Shusterman. 1994. Persistent respiratory health effects after a metam sodium pesticide spill. Chest 106: 500 508 Doty RL, Cometto Muniz JE, Jalowayski AA, Dalton P, Kendal Reed M, Hodgson M. ( 2004) Assessment of upper respiratory tract and ocular irritative effects of volatile chemicals in humans. Crit Rev Toxicol. 2004 Mar Apr; 34( 2): 85 142.

O'Malley, M, Barry, T, Verder Carlos, M, Rubin, A. 2004. Modeling of methyl isothiocyanate air concentrations associated with community illnesses following a metam sodium sprinkler application. American Journal of Industrial Medicine. 46: 1 15.

41221407 Rosskamp, G.; Schobel, G.; Bhargava, A.; et. al. ( 1978) T22 Methyl Isothiocyanate: ZK 3.318: A 12_ 13 Week Inhalation Study in the Rat: Project ID 374/ 77. Unpublished study prepared by Schering AG. 202 p.

44400401 Russell, M.; Rush, T. ( 1996) Methyl Isothiocyanate: Determination of Human Olfactory Detection Threshold and Human No Observable Effect Level for Eye Irritation: Lab Project Number: MITC_ UCD_ 1A_ 1993: MITC_ UCD_ 1B_ 1994: RR 96_ 049B. Unpublished study prepared by University of California and Western Research Center ( Zeneca). 136 p.

45314802 Klimisch, H. ( 1987) Study of the Subchronic Inhalation Toxicity of Methyl Isothiocyanate in Wistar Rats ( 4_ Week Study): Lab Project Number: 87/ 0244: 40I0231/ 8539. Unpublished study prepared by BASF Aktiengesellschaft. 272 p.

45919410 Jackson, G.; Clark, G.; Prentice, D.; et al. ( 1981) Methyl Isothiocyanate: Acute Inhalation Toxicity in Rats__ 4 Hour Exposure: Lab Project Number: 81/ 082: 378/ 801109. Unpublished study prepared by Huntingdon Research Center. 115 p.

US Environmental Protection Agency. 1994. Methods for derivation of inhalation reference concentrations and application of inhalation dosimetry. Office of Research and Development. EPA/ 600/ 8 90/ 066F, October 1994.

Valentine, W. M., Amarnath, V., Amarnath, K., and Graham, D. G. 1995. Characterization of protein adducts produced by N methyldithiocarbamate and N methyldithicarbamate esters. Chem. Res. Toxicol. 8: 254 261. Page 14 of 19 Appendix 1: Executive summaries of sub chronic inhalation studies with MITC. Page 15 of 19 CITATION: Klimisch, H. J. ( 1987). Study of the Subchronic Inhalation Toxicity of Methyl Isothiocyanate in Wistar Rats ( 4 weeks study). Department of Toxicology. BASF Aktiengesellschaft, D W6700 Ludwigshafen, Federal Republic of Germany. Project No 4010231/ 8539, BASF Reg. Document Number 87/ 0244, January 29, 1987. MRID 45314802. Unpublished.

EXECUTIVE SUMMARY: In a 28 day inhalation toxicity study ( MRID 45314802), Methyl Isothiocyanate [ 96.9 % a. i.] was administered to 5/ sex/ dose of SPF Wistar/ Chubb: THOM rats by whole body exposure at analytical concentrations of 0, 5.0, 20, or 100 mg/ m3 equivalent to 0, 5.0, 20, or 100 ug/ L ( measured concentrations 0, 5.1, 19.9 or 100 ug/ L) and ( equivalent to concentrations of 0, 1.7, 6.8, and 34 ppm) for 6 hours per day, 5 days/ week for a total of 28 days.

All animals survived to study termination. Mid and high dose rats demonstrated clinical signs during exposure from the third exposure period day. No clinical signs were observed in the low dose animals. According to the study report,

" During exposure, the animals of test group 2 showed eyelid closure, somnolence, and ruffled fur from the third day of exposure onwards. On the next morning before exposure nothing abnormal was found in the animals...... At 20 mg/ m3 the animals showed first indications of an irritating effect of the test substance and a slightly deteriorated general state of health."

Additional clinical signs observed at the high exposure concentration included reddish nasal discharge, salivation, eye discharge, and difficulty in breathing or whooping respiration, and stretched posture. In the high dose rats, although signs recovered between exposures at the beginning of the study, towards the end of the study ruffled fur and respiratory sounds were no longer reversible.

Body weight and body weight gain were significantly decreased ( p< 0.05) at the high dose. Food consumption and feed efficiency were not measured. There were decreases in plasma urea, glucose, triglyceride, and albumin the high dose males. In high dose females, urea and glucose were also decreased. In the males of mid exposure group, there was a decrease in urea concentration in the plasma.

At the mid and high exposure concentrations, increase in neutrophilic polymorphonuclear granulocytes in the peripheral blood was observed in males; this was also observed in the high exposure concentration for females.

There was increased lung weight at the high exposure concentration. Histopathology revealed an increase in incidence and severity of rhinitis in the nasal cavity at the high exposure concentration in both sexes ( incidence in males: 2/ 5, 2/ 5, 2/ 5, 5/ 5; females: 0/ 5, 3/ 5, 1/ 5, 5/ 5). Other histopathologic findings at the high exposure concentration included: atrophy of the olfactory epithelium, metaplasia of the nasal respiratory epithelium ( 3 males in section plane 1 only, 5 females in section planes 1 and, to a lesser extent, section plane 2), tracheal epithelial proliferation and single cell necrosis ( all high exposure concentration), bronchopneumonia and bronchial and bronchiolar epithelial proliferation ( 5 males, 2 females), and emphysema ( 3 males, 2 females). Page 16 of 19 The systemic LOAEL is 19.9 mg/ m3, ( 6.8 ppm), based on clinical signs consistent with irritation in both sexes and increased neutrophilic polymorphonuclear granulocytes in the blood of males. The systemic NOAEL is 5 mg/ m3 ( 1.7 ppm).

The LOAEL for effects in the extrathoracic ( ET) region is 100 mg/ m3, ( 34ppm), based on observation of pathological changes of the nasal cavity ( metaplasia of respiratory epithelium and atrophy of the olfactory epithelium). The ET NOAEL is 19.9 mg/ m3 ( 6.8 ppm).

The LOAEL for effects in the tracheabronchial ( TB) region is 100 mg/ m3 ( 34ppm), based on observation of pathological changes ( tracheal epithelial proliferation and single cell necrosis, bronchopneumonia and bronchial and bronchiolar epithelial proliferation). The TB NOAEL is 19.9 mg/ m3( 6.8 ppm).

This subchronic toxicity study is Acceptable but does not satisfy the guideline requirement for a subchronic inhalation study ( 82 4) in the rat. The study duration was too short and the number of animals used were inadequate to satisfy the Guideline requirement. Detailed tables of the clinical signs were not provided in the study report. Page 17 of 19 CITATION: Rosskamp, G.; Schobel, G.; Bhargava, A.; et. al. ( 1978) T22 Methyl Isothiocyanate: ZK 3.318: A 12 13 Week Inhalation Study in the Rat: Project ID 374/ 77. Prepared by Schering AG. November 26, 1975 MRID no. 41221407. Unpublished Davis, C. ( 1990) Nor Am Chemical Company Phase 3 Summary of MRID 41221407. Methyl Isothiocyanate: A 12 13 Week Inhalation Study in the Rat ( T22); Lab ID. No. 374/ 77. Prepared by Schering AG, Berlin, Federal Republic. September 26, 1978 MRID no. 92114013. Unpublished EXECUTIVE SUMMARY: In a subchronic inhalation study ( MRID no. 41221407) 4 groups of 10 Wistar rats/ sex/ dose received a nose only inhalation exposure to MITC ( 95.69% a. i., Batch no. 26,300) at 0, 3.16, 30.67, and 137.13 ug/ L for 4 hours/ day, 5 days/ week over a 12 to 13 week period ( By extrapolation from four to six hours of exposure, the dose levels are 0, 2.1, 20.6, and 91.9 ug/ L). There were two control groups of 10 rats/ sex/ dose, one maintained in the laboratory without inhalation exposure and the other in chamber without MITC.

No effects on urinalysis parameters, gross or microscopic pathology or organ weights were noted at any dose level. Although no clinical signs were noted in the low or middle dose groups, clinical signs of apathetic appearance accompanied with salivation and nasal discharge was observed throughout the study in high dose rats. Six of 20 rats in the high dose exhibited stimulated vocalization during the last 30 days of exposure.

A treatment related decrease in body weight gain was noted in male and females of the middle ( 11% M and 15% F, not statistically significant) and the high ( 63% M and 47% F, p < 0.01) dose groups. A treatment related increase in water consumption was noted in males and females of the mid dose group ( 14% and 21%, p < 0.05) and males of the high dose group ( 16%, p< 0.05). Food consumption, however, was decreased ( p < 0.05) in only the high dose group.

Hematological parameters of leucocyte and neutrophil counts and hematocrit and RBC values were significantly increased in the high dose group only. A significant decrease in total blood protein was noted in males and females of the mid dose group ( p< 0.05) and females of the high dose group. Changes in fasting glucose, alkaline phosphatase, and alanine aminotransferase were also in the high dose females.

Effects reported at the mid dose were decreased body weight, food efficiency and blood protein values accompanied by increased water intake. At the high dose ( 91.9 ug/ L) the animals exhibited apathy, salivation, nasal discharge, and stimulated vocalization. These animals exhibited a decrease in body weight, food intake, and food efficiency accompanied by an increase in water intake. Alterations in clinical chemistry values at this dose included decreased total protein with increased alkaline phosphatase and alanine aminotransferase values.

Overall, the results of this study are questionable for a variety reasons detailed by California Department of Pesticide Regulation. The following text was extracted from California Environmental Protection Agency, ( 2003) RISK CHARACTERIZATION DOCUMENT Methyl Isothiocyanate ( MITC) Following the Agricultural Use of Metam Sodium, Sacramento, California July, 2003. Page 18 of 19 It may be asked why the 12 13 week rat nose only inhalation study of Rosskamp ( 1978) did not provide the critical subchronic NOEL. In this study, the endpoints used to establish the NOEL of 1 ppm were decrements in weight gain, increased water consumption and decreased serum protein levels, all occurring at the LOEL concentration of 10 ppm. Overt toxicity in the form of salivation / nasal discharge, mild and moderate apathy, vocalization and a much more severe weight gain decrement were detected at the high dose of 45 ppm. However, there was massive uncertainty inherent in the study report, which made it very difficult to rely upon it for risk assessment purposes, particularly as another more adequate study using the same strain of rat was available. The uncertainties are delineated as follows:

1. The toxicologic significance of the three endpoints used to establish the NOEL was not clear. Statistically significant decreases in body weight gain with respect to sham treated controls only occurred at the high dose of 45 ppm, while a much lower, non statistically significant decrement was noted at the mid dose ( 10 ppm). Interestingly, a much larger suppression of body weight gain was evident in the sham treated controls when compared to the untreated controls than occurred when comparing the sham treated controls to the 10 ppm animals. This may indicate the presence of a stress effect imposed on the animals as they were fitted into the nose only apparatus day after day. Individual animal data were not supplied, making it impossible to say with assurance what the effect was on individual animals. In the case of water consumption, the increase that was observed compared to sham treated controls was statistically significant at both 10 and 45 ppm ( in females only at the latter dose), though the values at 45 ppm were not greater than those at 10 ppm. The significant decrease in serum protein in mid and high dose males and high dose females was conceivably a consequence of the increased water consumption. ( However, a similar lowering of serum protein was detected in the chronic mouse drinking water study in conjunction with a decrease in water consumption [ Sato, 1980], raising the possibility that protein levels were suppressed independent of an effect on water consumption, perhaps due to an effect of MITC on the liver.)

2. Insufficient analytic data were provided in the study report to validate the reported chamber concentrations. According to the report, MITC levels were determined at hours 1 and 3 during each 4 hour exposure by withdrawing the chamber air for 10 minutes and routing it to an infra red analyzer. The reported levels were thus mean values computed from hundreds of separate determinations. Without a report of the daily levels or, at the very least, standard deviations from the mean values, there is an implicit assumption that those mean values were in fact the levels that the animals were actually responding to, and were not in reality much lower or higher for significant periods. Page 19 of 19 3. Rosskamp ( 1978) failed to provide a histological examination of the nasal cavity of the exposed rats. As MITC is known to cause irritation of mucus membranes, the lack of nasal examination in that study may have resulted in the assignment of an inappropriately high NOEL value or, at the very least, an appreciation of the importance of irritation to the overall toxic response.

The LOAEL is 30.67 ug/ L/ day ( extrapolated to 20.6 ug/ L/ day for 6 hour exposure), based on decreased body weight, food efficiency and blood protein values accompanied by increased water intake. The NOAEL is 3.16 ug/ L/ day ( extrapolated to 2.1 ug/ L/ day for 6 hour exposure).

This subchronic inhalation toxicity study in the rat is acceptable guideline and satisfies the guideline requirement for a subchronic inhalation study OPPTS 870.3465; OECD 413 in the rat.


[Federal Register Volume 80, Number 211 (Monday, November 2, 2015)]
[Notices]
[Pages 67467-67469]
[FR Doc No: 2015-27800]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76283; File No. SR-DTC-2015-010]

Self-Regulatory Organizations; The Depository Trust Company;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Provide Additional Details Regarding the Requirement That Participants
Participate in Annual Testing of Business Continuity and Disaster
Recovery Plans

October 27, 2015.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (``Act'') and Rule 19b-4 \2\ thereunder, notice is hereby given
that on October 23, 2015, The Depository Trust Company (``DTC'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II, which Items have
been prepared by DTC. DTC filed the proposed rule change pursuant to
Section 19(b)(3)(A) \3\ of the Act and Rule 19b-4(f)(6) \4\ thereunder.
The proposed rule change was 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).
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I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    The proposed rule change consists of a change to DTC's Rule 2 to
provide additional details regarding the requirement that Participants
participate in annual testing of DTC's business continuity and disaster
recovery plans (``BCP Testing''), as more fully described below.\5\
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    \5\ Terms not otherwise defined herein have the meaning set
forth in DTC's rules, available at http://www.dtcc.com/legal/rules-and-procedures.aspx.
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II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

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

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

1. Purpose
    The proposed rule change would amend DTC's Rule 2 (Participants and
Pledgees) to provide additional details regarding the requirement that
DTC Participants participate in DTC's annual BCP Testing. Currently,
pursuant to DTC's Rule 2, an applicant for membership with DTC must
demonstrate that it has ``adequate personnel capable of handling
transactions with the Corporation and adequate physical facilities,
books and records and procedures to fulfill its anticipated commitments
to, and to meet the operational requirements of, the Corporation, other
Participants and Pledgees with necessary promptness and accuracy and to
conform to any condition and requirement which the Corporation
reasonably deems necessary for its protection.'' \6\ Once a firm
becomes a Participant of DTC, DTC Rule 2 provides that Participants may
be required to fulfill certain operational testing requirements that
may be imposed by DTC to test and monitor the continuing operational
capability of the Participants.\7\
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    \6\ DTC Rule 2, Section 1(b), supra, note 5.
    \7\ DTC Rule 2, Section 1, supra, note 5.
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    Recently, the Commission promulgated Regulation Systems Compliance
and Integrity (``Reg. SCI''), which requires DTC to establish standards
to designate members \8\ and

requires participation by such designated members in scheduled BCP
Testing with DTC on an annual basis.\9\ Although DTC already conducts
annual BCP Testing with certain Participants,\10\ DTC is proposing to
amend Rule 2 to further describe DTC's requirement with respect to BCP
Testing.
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    \8\ 17 CFR 242.1004(a). In adopting Reg. SCI, the Commission
determined not to require covered entities to notify the Commission
of its designations or the standards that will be used in
designating members, recognizing instead that each entity's
standards, designations, and updates, if applicable, would be part
of its records and, therefore, available to the Commission and its
staff upon request. See Securities and Exchange Act Release No.
73639 (November 19, 2014), 79 FR 72252 (December 5, 2014) (File No.
S7-01-13).
    \9\ 17 CFR 242.1004(a) and (b).
    \10\ DTC Rule 2, Section 1, supra, note 5.
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    The proposed amendments to Rule 2 would increase transparency
regarding BCP Testing, and ensure DTC's practice with respect to such
testing is consistent with Reg. SCI by setting forth DTC's rights to:
(i) Designate Participants required to participate in BCP Testing using
established standards; (ii) determine the scope and reporting of such
BCP Testing; and (iii) require Participants to comply with such BCP
Testing within specified timeframes. In connection with these proposed
amendments, DTC would refine the factors that it currently uses to
designate Participants for BCP Testing. For example, while DTC would
continue to rely on activity-based thresholds to mandate participation
with annual BCP Testing, DTC would also take into account additional
factors when designating firms for BCP Testing, including, but not
limited to: (i) Significant operational issues of the Participant
during the past twelve months; and (ii) past performance of the
Participant with respect to BCP Testing. Participants would be informed
of the specific standards that would be used by DTC, along with any
updates or changes to these standards, which would be applied on a
prospective basis, through established methods of communication between
DTC and its Participants. Likewise, Participants would be notified in
advance that they have been designated to participate in BCP Testing
for the upcoming year, and would be provided details concerning the
nature of such testing as the particular test plans are determined.
    DTC believes the proposed rule change would have no impact on DTC
Participants relative to what Participants are currently required to
do. As described above, DTC already requires certain Participants to
participate in BCP Testing on an annual basis. The proposed rule change
would provide further clarity with respect to these requirements for
consistency with Reg. SCI.
2. Statutory Basis
    Section 17A(b)(3)(F) of the Act requires, in part, that DTC's rules
be designed to promote the prompt and accurate clearance and settlement
of securities transactions and to protect investors and the public
interest.\11\
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    Rule 17Ad-22(d)(2), promulgated under the Act, requires DTC to
require that its Participants have robust operational capacity to meet
obligations arising from participation in the clearing agency, to
monitory that its participation requirements are met on an ongoing
basis, and to have participation requirements that are objective and
publicly disclosed.\12\ Rule 17Ad-22(d)(4), promulgated under the Act,
requires DTC to identify sources of operational risk and minimize them
through the development of appropriate systems, controls, and
procedures, and have business continuity plans that allow for timely
recovery of operations and fulfillment of the clearing agency's
obligations.\13\
---------------------------------------------------------------------------

    \12\ 17 CFR 240.17Ad-22(d)(2).
    \13\ 17 CFR 240.17Ad-22(d)(4).
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    Rule 1004(a) and (b) of Reg. SCI requires DTC to establish
standards for the designation of those Participants that DTC reasonably
determines are, taken as a whole, the minimum necessary for the
maintenance of fair and orderly markets in the event of the activation
of its business continuity and disaster recovery plans, and to
designate Participants pursuant to those standards and require
participation by such designated Participants in scheduled BCP Testing
annually.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 242.1004(a) and (b).
---------------------------------------------------------------------------

    By facilitating the testing of how business continuity and disaster
recovery plans function between DTC and its Participants during an
emergency, the proposed rule change would facilitate the prompt and
accurate clearance and settlement of securities transactions and
protect investors and the public interest consistent with of the Act.
The proposed rule change would provide additional details to DTC's
rules regarding the requirement for Participants to take part in its
BCP Testing annually, strengthening its compliance with Rule 17Ad-
22(d)(2) and (4).\15\ Further, the proposed rule change would foster
the objectives of the Commission under Reg. SCI by helping to ensure
resilient and available markets.\16\
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    \15\ 17 CFR 240.17Ad-22(d)(2) and (4).
    \16\ 17 CFR 242.1004(a) and (b).
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    As such, DTC believes that the proposed rule change is consistent
with Section 17A(b)(3)(F) of the Act, Rule 17Ad-22(d)(2) and (d)(4),
promulgated under the Act, and Rule 1004(a) and (b) of Reg. SCI, cited
above.

(B) Clearing Agency's Statement on Burden on Competition

    DTC does not believe that the proposed rule change would impose any
burden on competition because the proposed rule change would apply to
all Participants and only provides additional details regarding an
existing requirement.

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants, or Others

    Written comments were not and are not intended to be solicited with
respect to the proposed rule change, and none have been received.

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

    Because the foregoing 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, it has
become effective pursuant to Section 19(b)(3)(A) \17\ of the Act and
Rule 19b-4(f)(6) thereunder.\18\
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    \17\ 15 U.S.C. 78s(b)(3)(A).
    \18\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires DTC to give the Commission written notice of DTC's intent
to file the proposed rule change, along with a brief description and
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. The Commission deems this
requirement to have been met.
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    A proposed rule change filed under Rule 19b-4(f)(6) \19\ normally
does not become operative for 30 days after the date of filing.
However, pursuant to Rule 19b-4(f)(6)(iii) \20\ the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest.
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    \19\ 17 CFR 240.19b-4(f)(6).
    \20\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    NSCC has asked the Commission to waive the 30-day operative delay
so that the proposal may become operative immediately upon filing.
According to NSCC, the proposed rule change does not present any novel
or controversial issues. Rather, NSCC is merely providing additional
details regarding BCP Testing requirements or adding provisions that
are consistent with or required by Reg. SCI. Accordingly, the

Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest as
it will allow NSCC to incorporate changes required under Reg. SCI prior
to the November 3, 2015 compliance date. Therefore, the Commission
designates the proposed rule change to be operative upon filing.\21\
---------------------------------------------------------------------------

    \21\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    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.

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-DTC-2015-010 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-DTC-2015-010. 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 the filing also will be available
for inspection and copying at the principal office of DTC and on DTCC's
Web site (http://dtcc.com/legal/sec-rule-filings.aspx). 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-DTC-2015-010 and should be
submitted on or before November 23, 2015.
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    \22\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\22\
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-27800 Filed 10-30-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 125 (Thursday, June 28, 2012)]
[Rules and Regulations]
[Pages 38475-38476]
[FR Doc No: 2012-15699]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2012-0345; Airspace Docket No. 12-AWP-3]

Amendment of Class E Airspace; Woodland, CA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class E airspace at Watts-Woodland Airport,
Woodland, CA. The projected decommissioning of the Travis VHF Omni-
Directional Radio Range (VOR) has made this action necessary for the
safety and management of Instrument Flight Rules (IFR) operations at
the airport. This action also makes a minor adjustment to the
geographic coordinates of the airport.

DATES: Effective date, 0901 UTC, September 20, 2012. The Director of
the Federal Register approves this incorporation by reference action
under 1 CFR part 51, subject to the annual revision of FAA Order 7400.9
and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Eldon Taylor, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On April 18, 2012, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM) to amend controlled airspace at
Woodland, CA (77 FR 23172). Interested parties were invited to
participate in this rulemaking effort by submitting written comments on
the proposal to the FAA. No comments were received. Subsequent to
publication the National Aeronautical Navigation Services requested a
minor adjustment to the geographic coordinates of the airport be made.
Except for a minor editorial change, this rule is the same as published
in the NPRM.
    Class E airspace designations are published in paragraph 6005, of
FAA Order 7400.9V dated August 9, 2011, and effective September 15,
2011, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in that Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by amending Class E airspace extending upward from 700 feet
above the surface, at Watts-Woodland Airport, Woodland, CA. Airspace
reconfiguration is necessary due to the projected decommissioning of
the Travis VOR, and enhances the safety and management of IFR
operations at the airport. The geographic coordinates of the airport
are adjusted to coincide with the FAA's aeronautical database.
    The FAA has determined this regulation only involves an established
body of technical regulations for which frequent and routine amendments
are necessary to keep them operationally current. Therefore, this
regulation: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act. The FAA's authority to
issue rules regarding aviation safety is found in Title 49 of the U.S.
Code. Subtitle 1, Section 106 discusses the authority of the FAA
Administrator. Subtitle VII, Aviation Programs, describes in more
detail the scope of the agency's authority. This rulemaking is
promulgated under the authority described in Subtitle VII, Part A,
Subpart I, Section 40103. Under that section, the FAA is charged with

prescribing regulations to assign the use of airspace necessary to
ensure the safety of aircraft and the efficient use of airspace. This
regulation is within the scope of that authority as it amends
controlled airspace at Watts-Woodland Airport, Woodland, CA.

Environmental Review

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

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR Part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9V, Airspace Designations and
Reporting Points, dated August 9, 2011, and effective September 15,
2011 is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

AWP CA E5 Woodland, CA [Amended]

Woodland, Watts-Woodland Airport, CA
    (Lat. 38[deg]40'26'' N., long. 121[deg]52'19'' W.)

    That airspace extending upward from 700 feet above the surface
within a 2.6-mile radius of Watts-Woodland Airport, and within 2.6
miles each side of the Watts-Woodland Airport 133[deg] bearing
extending from the 2.6-mile radius to 8.1 miles southeast of Watts-
Woodland Airport, and within 1.8 miles each side of the Watts-
Woodland Airport 172[deg] bearing extending from the 2.6-mile radius
to 6 miles south of the airport, and within 1.9 miles each side of
the Watts-Woodland Airport 345[deg] bearing extending from the 2.6-
mile radius to 7 miles north of the airport.

    Issued in Seattle, Washington, on June 19, 2012.
Vered Lovett,
Acting Manager, Operations Support Group, Western Service Center.
[FR Doc. 2012-15699 Filed 6-27-12; 8:45 am]
BILLING CODE 4910-13-P