[Federal Register Volume 78, Number 229 (Wednesday, November 27, 2013)]
[Rules and Regulations]
[Pages 70851-70854]
[FR Doc No: 2013-28638]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0974; Directorate Identifier 2013-NM-209-AD;
Amendment 39-17675; AD 2013-24-01]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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SUMMARY: We are adopting a new airworthiness directive (AD) for The
Boeing Company Model 747-8 and 747-8F series airplanes and Model 787-8
airplanes powered by GEnx engines. This AD requires revising the
airplane flight manual to advise the flight crew of potential ice
crystal icing (ICI) conditions at high altitudes, and to prohibit
operation in moderate and severe ICI conditions. This AD also requires
inspecting the engine after any ICI event is detected by the flight
crew. This AD was prompted by reports of engine damage and thrust loss
events as a result of flying in high altitude ICI conditions. We are
issuing this AD to ensure that the flight crews have operating
instructions to avoid flight into ICI conditions that can lead to
engine damage and thrust loss events; unrecoverable thrust loss on
multiple engines can lead to a forced landing.

DATES: This AD is effective November 27, 2013.
    We must receive comments on this AD by January 13, 2014.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Office (phone:<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Sue Lucier, Aerospace Engineer,
Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification Office
(ACO), 1601 Lind Avenue SW., Renton, Washington 98057-3356; phone: 425-
917-6438; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    Over the past decade, we have been aware of temporary engine thrust
loss, and other engine-related events that occurred in ice crystal
icing (ICI) conditions at high altitudes. These events have prompted
the release of ADs on various airplane models equipped with General
Electric (GE) CF6-80 series engines. Each event was in or near
convective weather conditions that included ice crystal icing.
    This type of icing does not appear on radar due to its low
reflectivity, and neither the airplane ice detector nor visual
indications reliably indicate the presence of icing conditions.
Therefore, it is often undetected by the flight crew. Flight in these
conditions can cause ice crystals to accumulate in the core gas flow
path of the engine. In the events leading to those prior ADs, the ice
has shed during throttle transients and in the descent phase of flight,
causing temporary thrust loss.
    Since the beginning of 2013, similar events have now occurred on
Model 747-8 and 747-8F series airplanes powered by GEnx-2B engines and
Model 787-8 airplanes powered by GEnx-1B engines. The new events that
prompted this AD, however, have occurred during the cruise phase of
flight and caused permanent damage (beyond maintenance manual limits)
to the engine compressor. In all thrust loss events, data indicate that
ice crystals entered and collected in the initial stages of the
compressor. Engine temperature data indicate small ice accretions were
shed through the core of the engine.
    All of these ICI events occurred during cruise at 33,000 feet or
above, either within or after the airplane traversed a large Mesoscale
Convective System (MCS). MCSs are areas where several thunderstorms
have merged, with a continuous cloud larger than 100 kilometers (62
miles) across.
    Within or near MCSs, ICI events have occurred where convective
activity has driven a significant quantity of moisture, in the form of
ice crystals, to altitudes at or above the tropopause. ICI events tend
to occur in warm geographic locations.
    As of the date of this AD, there have been nine events on Model
747-8 airplanes and Model 787-8 airplanes.
    During two events on Model 747-8F airplanes, two engines
experienced thrust losses during the cruise phase of flight. In one of
these events, one of the engines recovered to idle but would not
accelerate and was left at idle for the rest of the flight. The other
engine recovered and operated normally for the rest of the flight. In
both airplane events, subsequent inspections of all four engines
revealed compressor damage on both of the event engines as well as
damage to a third engine that had not experienced a thrust loss.
    In four other events--one on a Model 787-8 airplane and three on
Model 747-8 airplanes--uncommanded engine decelerations (i.e., thrust
losses) of approximately 20 seconds in duration occurred. All engines
automatically recovered commanded thrust without crew action and
operated normally for the rest of the flight.
    In three other events on Model 747-8 airplanes, at least one engine
showed elevated vibrations on the low-speed engine spool (N1) while in
ICI conditions. The vibrations stopped after the airplanes exited the
weather system, and the engines operated normally for the rest of the
flight.
    Unrecoverable thrust loss on multiple engines, due to operation in
high altitude clouds containing ice crystals, could lead to a forced
landing.

FAA's Determination

    We are issuing this AD because we evaluated all the relevant
information

and determined the unsafe condition described previously is likely to
exist or develop in other products of these same type designs.

AD Requirements

    This AD requires revising the Certificate Limitations and Operating
Procedures chapters of the AFM to advise the flight crew of potential
ICI conditions at high altitudes, and to provide procedures to prohibit
flight into those conditions.
    This AD also requires engine inspections after any event where the
flight crew reports the appearance of the ``ENGINE THRUST'' message on
the engine indication and crew alert system (EICAS) for any engine. The
intent of the inspection requirement is to verify the airworthiness of
the airplane for future flights. Because of thrust requirements on the
different airplane models, the inspection is required before further
flight on a minimum of three engines on Model 747-8 and 747-8F series
airplanes, and on both engines on Model 787-8 airplanes.

Interim Action

    We consider this AD interim action. If final action is later
identified, we might consider further rulemaking then.

FAA's Justification and Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because
flight in potential ICI at high altitudes could result in engine damage
and loss of thrust and consequent forced landing. Therefore, we find
that notice and opportunity for prior public comment are impracticable
and that good cause exists for making this amendment effective in less
than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety and was not preceded by notice and an opportunity for public
comment. However, we invite you to send any written data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include the docket number FAA-2013-0974 and
Directorate Identifier 2013-NM-209-AD at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this AD. We will
consider all comments received by the closing date and may amend this
AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Costs of Compliance

    We estimate that this AD affects 14 airplanes of U.S. registry. We
estimate the following costs to comply with this AD:

                                         Estimated Costs: AFM Revisions
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                                                                                Cost per       Cost on U.S.
               Action                        Labor cost           Parts cost        product         operators
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AFM revisions.......................  1 work-hour x $85 per                $0              $85           $1,190
                                       hour = $85.
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                                           Estimated Costs: Inspection
----------------------------------------------------------------------------------------------------------------
               Action                        Labor cost           Parts cost            Cost per product
----------------------------------------------------------------------------------------------------------------
Inspection..........................  2 work-hours x $85 per               $0   $680 per airplane
                                       hour = $170 per engine.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
cost estimates for the on-condition corrective actions specified in
this AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation Programs''
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (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),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2013-24-01 The Boeing Company: Amendment 39-17675; Docket No. FAA-
2013-0974; Directorate Identifier 2013-NM-209-AD.

(a) Effective Date

    This AD is effective November 27, 2013.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company airplanes, certificated in
any category, identified in paragraphs (c)(1) and (c)(2) of this AD.
    (1) Model 747-8 and 747-8F series airplanes powered by GEnx-2B67
or GEnx-2B67B engines.
    (2) Model 787-8 airplanes powered by GEnx-1B64, GEnx-1B67, GEnx-
1B70, GEnx-1B64/P1, GEnx-1B67/P1, GEnx-1B70/P1, or GEnx-1B70/75/P1
engines.
    Note 1 to paragraph (c)(2) of this AD: The engine nameplate may
also include a suffix such as ``G03,'' which is the applicable Bill
of Materials (See FAA Type Certification Data Sheet T00021SE basic
model identifier).

(d) Subject

    Air Transport Association (ATA) of America Code 71, Power plant.

(e) Unsafe Condition

    This AD was prompted by reports of engine damage and thrust loss
events as a result of flying in high altitude ice crystal icing
(ICI) conditions. We are issuing this AD to ensure that the flight
crews have operating instructions to avoid flight into ICI
conditions that can lead to engine damage and thrust loss events. We
are also issuing this AD to ensure the airplane has a minimum number
of airworthy engines following a potential high altitude ICI
encounter. Operation with more than one engine having icing damage
can lead to a common cause loss of thrust on multiple engines, which
can lead to a forced landing.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Revision of Airplane Flight Manual (AFM): Certificate Limitations

    Within 7 days after the effective date of this AD, revise the
Certificate Limitations chapter of the applicable Boeing AFM to
include the statement provided in figure 1 to paragraph (g) of this
AD. This may be done by inserting a copy of this AD into the AFM.

Figure 1 to Paragraph (g) of This AD--Certificate Limitations

AVOIDANCE OF ICE CRYSTAL ICING

(Required by AD 2013-24-01.)

    In order to prevent loss of thrust and engine damage due to ice
crystal icing, for operations at or above 30,000 feet, when
approaching, or in, instrument meteorological conditions or visible
moisture:
    The flight crew must comply with the Avoidance of Ice Crystal
Icing procedure contained in the Operating Procedures chapter of
this manual.
    When following the Avoidance of Ice Crystal Icing procedure,
flight is prohibited within 50NM of amber or red radar returns that
are displayed below the airplane's flight path.

    Note 2 to figure 1 to paragraph (g), figure 2 to paragraph (h),
and figure 3 to paragraph (i) of this AD:  When statements identical
to those in figures 1, 2, and 3 to paragraphs (g), (h), and (i) of
this AD, respectively, have been included in the applicable chapters
of the general revisions of the applicable AFM, the general
revisions may be inserted into the AFM, and the copy of this AD may
be removed from the AFM.

(h) AFM Revision: Model 747-8 and 747-8F Operating Procedures

    For Model 747-8 (Intercontinental) and 747-8F (Freighter) series
airplanes: Within 7 days after the effective date of this AD, revise
the Operating Procedures chapter of the Boeing 747-8 AFM to include
the statement provided in figure 2 to paragraph (h) of this AD. This
may be done by inserting a copy of this AD into the AFM.

Figure 2 to Paragraph (h) of This AD--Model 747-8 Operating Procedures

AVOIDANCE OF ICE CRYSTAL ICING

(Required by AD 2013-24-01.)

    This procedure is required by the AVOIDANCE OF ICE CRYSTAL ICING
limitation contained in the Certificate Limitations chapter of this
manual. The language below shall not be modified.
    Operations in ice crystal icing can cause unrecoverable loss of
thrust and engine damage due to ice crystal icing.
    For operations at or above 30,000 feet, when approaching, or in,
instrument meteorological conditions or visible moisture:
    Operate weather radar in automatic mode and gain knob set to the
12 o'clock position, or if in manual mode adjust gain to maximum and
set tilt between -1 and -3.
    If areas of green, amber or red weather radar returns are
observed along the flight path:
    Use manual weather radar tilt control mode and vary the tilt
between -3 and -5 degrees and set the gain knob to the 12 o'clock
position to determine if amber or red returns are present below the
airplane's flight path.
    Flight is prohibited within 50NM of amber or red radar returns
that are displayed below the airplane's flight path.

(i) AFM Revision: Model 787-8 Operating Procedures

    For Model 787-8 airplanes: Within 7 days after the effective
date of this AD, revise the Operating Procedures chapter of the
Boeing 787 AFM to include the statement provided in figure 3 to
paragraph (i) of this AD. This may be done by inserting a copy of
this AD into the AFM.

Figure 3 to Paragraph (i) of This AD--Model 787-8 Operating Procedures

AVOIDANCE OF ICE CRYSTAL ICING

(Required by AD 2013-24-01.)

    This procedure is required by the AVOIDANCE OF ICE CRYSTAL ICING
limitation contained in the Certificate Limitations chapter of this
manual. The language below shall not be modified.
    Operations in ice crystal icing can cause unrecoverable loss of
thrust and engine damage due to ice crystal icing.
    For operations at or above 30,000 feet, when approaching, or in,
instrument meteorological conditions or visible moisture:
    Operate weather radar in automatic mode and 0 manual gain
adjustment, or if in manual mode adjust gain to maximum and set tilt
between -1 and -3.
    If areas of green, amber or red weather radar returns are
observed along the flight path:
    Use manual weather radar tilt control mode and vary the tilt
between -3 and -5 degrees and select 0 manual gain adjustment to
determine if amber or red returns are present below the airplane's
flight path.
    Flight is prohibited within 50NM of amber or red radar returns
that are displayed below the airplane's flight path.

(j) Post-Event Inspections

    After any flight crew report of the appearance of an engine
indicating and crew alerting system (EICAS) message that displays
``ENG THRUST (L,R)'' (for Model 787-8 airplanes) or ``ENG (1, 2, 3,
or 4) THRUST'' (for Model 747-8 and 747-8F airplanes) during
operation at or above 30,000 feet pressure altitude: Do borescope
inspections of the first stage blade of the high pressure compressor
of the engines to detect damage, as specified in paragraph (j)(1) or
(j)(2) of this AD, as applicable. Correct any damage before further
flight.
    (1) For Model 747-8 and 747-8F series airplanes: Before further
flight, inspect each engine for which an EICAS ENGINE THRUST message
was displayed. A minimum total of 3 engines must be inspected before
further flight. Within 5 flight cycles after the EICAS message was
displayed, inspect the fourth engine, unless already accomplished as
specified in this paragraph.
    (2) For Model 787-8 airplanes: Before further flight, inspect
both engines.

(k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in paragraph (k) of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector,

or lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.

(l) Related Information

    (1) For more information about this AD, contact Sue Lucier,
Aerospace Engineer, Propulsion Branch, ANM-140S, FAA, Seattle
Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton,
Washington 98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    (2) Refer to the applicable information specified in paragraph
(l)(2)(i) or (l)(2)(ii) of this AD for guidance on inspecting the
engine and correcting damage.
    (i) For Model 747-8 and 747-8F series airplanes: Refer to Task
72-00-00-290-801-G00, High Pressure Compressor Section (with a
Borescope) Detailed Inspection, of Subject 72-00-00, Engine--
Inspection/Check, of Chapter 72, Engine, of the Boeing 747-8
Aircraft Maintenance Manual.
    (ii) For Model 787-8 airplanes: Refer to Data Module DMC-B787-A-
G72-00-00-06B-280C-A, High Pressure Compressor Section (with a
Borescope)--Special Detailed Inspection, of the Boeing 787-8
Aircraft Maintenance Manual.
    (3) For Boeing service information identified in this AD that is
not incorporated by reference, contact Boeing Commercial Airplanes,
Attention: Data & Services Management, P. O. Box 3707, MC 2H-65,
Seattle, WA 98124-2207; telephone<PHONE_NUMBER>, extension 1; fax
206-766-5680; Internet https://www.myboeingfleet.com. You may view
this service information at the FAA, Transport Airplane Directorate,
1601 Lind Avenue SW., Renton, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

(m) Material Incorporated by Reference

    None.

    Issued in Renton, Washington, on November 22, 2013.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-28638 Filed 11-26-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 187 (Thursday, September 26, 2019)]
[Rules and Regulations]
[Pages 50764-50766]
[FR Doc No: 2019-20530]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0645; FRL-9998-67]

Florpyrauxifen-benzyl; Exemption From the Requirement of a
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of the florpyrauxifen-benzyl on all food
and feed commodities when applied or used as an herbicide under good
agricultural practices. This regulation eliminates the need to
establish a maximum permissible level for residues of florpyrauxifen-
benzyl.

DATES: This regulation is effective September 26, 2019. Objections and
requests for hearings must be received on or before November 25, 2019,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2018-0645, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

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

I. General Information

A. Does this action apply to me?

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

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Publishing Office's e-CFR site at
http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2018-0645 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
November 25, 2019. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2018-0645, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance Action

    In the Federal Register of December 21, 2018 (83 FR 65660) (FRL-
9985-67), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 8F8675) by Dow AgroSciences, 9330 Zionsville Road,
Indianapolis, IN 46268. The petition requested that 40 CFR part 180 be
amended by establishing an exemption from the requirement of a
tolerance for residues of florpyrauxifen-benzyl. That document
referenced a summary of the petition prepared by the petitioner, Dow
AgroSciences, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), which requires EPA to give special
consideration to exposure of infants and children to the pesticide

chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.

A. Toxicological Profile

    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. The nature of the toxic effects caused by
florpyrauxifen-benzyl are discussed in this unit.
    Florpyrauxifen-benzyl is not genotoxic and there were no treatment
related findings up to the limit dose (1,000 milligrams/kilogram (mg/
kg)/day) or highest doses tested in the acute, short-term, sub-chronic,
or chronic oral toxicity studies, 2-generation reproduction or
developmental toxicity studies or in the neurotoxicity study.
    Chronic administration of florpyrauxifen-benzyl did not show any
carcinogenicity potential and did not cause any adverse effects in
mice, rats or dogs even up to the highest doses tested. Given the
absence of adverse effects or toxicity in the database, the Agency did
not establish any toxicity endpoints or points of departure for
conducting a quantitative risk assessment. In a qualitative assessment
of risk, the Agency does not use uncertainty factors, which means that
the safety factor required section 408(b)(2)(C) of FFDCA in the case of
threshold effects for the protection of infants and children is not
applicable. The Agency has determined that there are no residual
uncertainties in the toxicity or exposure databases, and there is no
evidence of increased susceptibility of infants or children from
exposure to florpyrauxifen-benzyl. Based on its review of the available
data, the Agency concludes that a qualitative assessment without
uncertainty or safety factors would be safe for infants and children.
    Specific information on the studies received and the nature of the
adverse effects caused by florpyrauxifen-benzyl as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled ``Florpyrauxifen-benzyl: New
Active Ingredient, First Food Use. Human Health Risk Assessment for the
Establishment of Permanent Tolerances on Rice, Fish, and Shellfish and
Registration for Uses on Rice and Freshwater Aquatic Weed Control'' in
docket ID number EPA-HQ-OPP-2018-0645.

B. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs EPA to
consider available information concerning exposures from the pesticide
residue in food and all other non-occupational exposures, including
drinking water from ground water or surface water and exposure through
pesticide use in gardens, lawns, or buildings (residential and other
indoor uses).
    There is potential for exposure to florpyrauxifen-benzyl via food
and drinking water based on the proposed and approved uses. In
addition, there is a potential for non-occupational, non-dietary
exposure to swimmers in waters treated with florpyrauxifen-benzyl. But
because no adverse effects were observed in the submitted toxicological
studies for florpyrauxifen-benzyl regardless of the route of exposure,
a qualitative assessment of risk is appropriate for this compound.

C. Cumulative Effects From Substances With a Common Mechanism of
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
    EPA has not found florpyrauxifen-benzyl to share a common mechanism
of toxicity with any other substances, and florpyrauxifen-benzyl does
not appear to produce a toxic metabolite produced by other substances.
For the purposes of this tolerance action, therefore, EPA has assumed
that florpyrauxifen-benzyl does not have a common mechanism of toxicity
with other substances. For information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see EPA's website at
http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Determination of Safety for U.S. Population, Infants and Children

    Based on the information in this preamble and the supporting
documentation, EPA concludes that there is a reasonable certainty of no
harm from aggregate exposure to florpyrauxifen-benzyl residues.
Accordingly, EPA finds that exempting florpyrauxifen-benzyl residues
from the requirement of a tolerance when applied or used as an
herbicide in accordance with good agricultural practices will be safe.

IV. Analytical Enforcement Methodology

    An analytical method is not required because EPA is establishing an
exemption from the requirement of a tolerance without any numerical
limitation because of the lack of toxicity concern about the presence
of residues.

V. Conclusion

    Therefore, an exemption is established for residues of
florpyrauxifen-benzyl, including its metabolites and degradates, in or
on all food commodities, when it is applied as an herbicide according
to good agricultural practices. In addition, although not requested in
the petition, EPA is removing from the Title 40 of the Code of Federal
Regulations section 180.695 and the established tolerances on fish--
freshwater finfish; fish--shellfish, crustacean; fish--shellfish,
mollusc; and rice, grain. The residues on those commodities are
subsumed within the new exemption, so the existing numerical tolerances
are redundant and no longer necessary.

VI. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this action has been exempted from review
under Executive Order 12866, this action is not subject to Executive
Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001) or Executive

Order 13045, entitled ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997), nor is
it considered a regulatory action under Executive Order 13771, entitled
``Reducing Regulations and Controlling Regulatory Costs'' (82 FR 9339,
February 3, 2017). This action does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA) (44 U.S.C. 3501 et seq.), nor does it require any special
considerations under Executive Order 12898, entitled ``Federal Actions
to Address Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the exemption in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: August 29, 2019.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

Sec.  180.695  [Removed]

0
 2. Remove Sec.  180.695.

0
 3. Add Sec.  180.1371 to subpart D to read as follows:

Sec.  180.1371  Florpyrauxifen-benzyl; exemption from the requirement
of a tolerance.

    An exemption from the requirement of a tolerance is established for
residues of florpyrauxifen-benzyl, including its metabolites and
degradates, in or on all food and feed commodities, when it is applied
as an herbicide in accordance with good agricultural practices.

[FR Doc. 2019-20530 Filed 9-25-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: June 3, 2008 (Volume 73, Number 107)]
[Notices]
[Page 31697]
[DOCID:fr03jn08-49]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-E-0335] (formerly Docket No. 2007E-0133) and
[Docket No. FDA-2007-E-0227] (formerly Docket No. 2007E-0148)

Determination of Regulatory Review Period for Purposes of Patent
Extension; TYZEKA; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of May 15, 2008 (73 FR 28119),
announcing FDA's determination of the regulatory review period for
TYZEKA. The document published with an incorrect docket number. This
document corrects that error.

FOR FURTHER INFORMATION CONTACT: Joyce Strong, Office of Policy,
Planning and Preparedness (HF-27), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In FR Doc. E8-10857, published on May 15,
2008 (73 FR 28119), the following correction is made:
    On page 28119, in the third column, in the Docket No. heading,
``Docket No. FDA-2007-E-0035'' is corrected to read ``Docket No. FDA-
2007-E-0335''.

    Dated: May 27, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-12300 Filed 6-2-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 77, Number 215 (Tuesday, November 6, 2012)]
[Notices]
[Pages 66620-66621]
[FR Doc No: 2012-27003]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0748]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Generic Drug User Fee
Cover Sheet; Form FDA 3794

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by
December 6, 2012.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-NEW and
title ``Generic Drug User Fee Cover Sheet; Form FDA 3794.'' Also
include the FDA docket number found in brackets in the heading of this
document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Generic Drug User Fee Cover Sheet; Form FDA 3794--(OMB Control Number
0910-New)

    On July 9, 2012, the Generic Drug User Fee Act (GDUFA) (Pub. L.
112-144, Title 111) was signed into law by the President. GDUFA,
designed to speed the delivery of safe and effective generic drugs to
the public and reduce costs to industry, requires that generic drug
manufacturers pay user fees to finance critical and measurable program
enhancements. The user fees required by GDUFA are as follows: A one-
time fee for original abbreviated new drug applications (ANDAs) pending
on October 1, 2012, (also known as backlog applications); fees for type
II active pharmaceutical ingredient (API) and final dosage form (FDF)
facilities; fees for new ANDAs and prior approval supplements (PASs);
and a one-time fee for drug master files (DMFs).
    The purpose of this notice is to solicit feedback on the collection
of information in an electronic form used to calculate and pay generic
drug user fees. Proposed Form FDA 3794, the Generic Drug User Fee Cover
Sheet, requests the minimum necessary information to determine if a
person has satisfied all relevant user fee obligations. The proposed
form is modeled on other FDA user fee cover sheets, including Form FDA
3397, the Prescription Drug User Fee Act Cover Sheet. The information
collected would be used by the FDA to initiate the administrative
screening of generic drug submissions and DMFs, support the inspection
of generic drug facilities, and

otherwise support the generic drug program. A copy of the proposed form
will be available in the docket for this notice.
    Respondents to this proposed collection of information would be
potential or actual generic application holders and/or related
manufacturers (manufacturers of FDF and/or APIs). Companies with
multiple applications will submit a cover sheet for each application
and facility. Based on FDA's database of application holders and
related manufacturers, we estimate that 500 companies would submit a
total of 3,850 cover sheets annually to pay for application and
facility user fees. FDA estimates that the 3,850 annual cover sheet
responses would break down as follows: \1\ 2,000 facilities fees, 750
ANDAs, 750 PASs, and 350 Type II API DMFs. We also estimate that the
one-time backlog fee would affect 350 application owners sponsoring
2,700 applications. The estimated hours per response are based on FDA's
past experience with other submissions, and range from approximately
0.1 to 0.5 hours. The hours per response are estimated at the upper end
of the range to be conservative.
---------------------------------------------------------------------------

    \1\ These estimates are based on conversations between the
Agency and representatives of regulated industry during the generic
drug user fee negotiations.
---------------------------------------------------------------------------

    In the Federal Register of July 26, 2012 (77 FR 43844), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received the following comment. Small
generic manufacturers will heavily suffer from the establishment fees
under GDUFA. FDA notes this comment is outside the scope of the
proposed collection of information, Form FDA 3794 (Generic Drug User
Fee Cover Sheet).
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
          FDA Form No.               Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
FDA 3794 \2\....................             500             7.7           3,850             0.5           1,925
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ For all applicable applications and fees except for the backlog fee.

    The backlog fee is a one-time fee. The Agency expects the majority
of these fees to be received in the first year only. The estimated
reporting burden for the backlog fee is shown in table 2 of this
document.

                             Table 2--Estimated One-Time Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
          FDA Form No.               Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
FDA 3794 \2\....................             350             7.7           2,700             0.5           1,350
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ For backlog fee.

    Dated: October 31, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-27003 Filed 11-5-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: November 22, 2006 (Volume 71, Number 225)]
[Notices]
[Page 67577-67579]
[DOCID:fr22no06-72]

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ENVIRONMENTAL PROTECTION AGENCY

[OW-2006-0064, FRL-8246-5]

U.S. EPA's National Clean Water Act Recognition Awards
Presentation During the Water Environment Federation's Technical
Exposition and Conference (WEFTEC), and Announcement of 2006 National
Awards Winners

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency recognized municipalities
and industries for outstanding and innovative technological
achievements in wastewater treatment and pollution abatement programs.
An inscribed plaque was presented to first and second place national
winners at the annual Clean Water Act Recognition Awards presentation
during the Water Environment Federation's Technical Exposition and
Conference (WEFTEC). Recognition is made every year for outstanding
programs and projects in operations and maintenance at wastewater
treatment facilities, biosolids management and public acceptance,
municipal implementation and enforcement of local pretreatment
programs, cost-effective storm water controls, and combined sewer
overflow controls. This action also announces the 2006 national awards
winners.

DATES: Monday, October 23, 2006, 11:30 a.m. to 1 p.m.

ADDRESSES: The national awards presentation ceremony was held at the
Dallas Convention Center, 650 S. Griffin Street, Dallas, Texas.

FOR FURTHER INFORMATION CONTACT: Maria E. Campbell, Telephone: (202)
564-0628. Facsimile Number:<PHONE_NUMBER>. E-Mail:
<EMAIL_ADDRESS>Also visit the Office of Wastewater

Management's webpage at http://www.epa.gov/owm.

SUPPLEMENTARY INFORMATION: The Clean Water Act Recognition Awards are
authorized by section 501(a) and (e) of the Clean Water Act, and 33
U.S.C. 1361(a) and (e). Applications and nominations for the national
awards are recommended by EPA regions. A regulation establishes a
framework for the annual recognition awards program at 40 CFR part 105.
EPA announced the availability of application and nomination
information for this year's awards (71 FR 23919, April 25, 2006). The
awards program enhances national awareness of municipal wastewater
treatment and encourages public

support of programs targeted to protecting the public's health and
safety and the nation's water quality. State water pollution control
agencies and EPA regional offices make recommendations to headquarters
for the national awards. Programs and projects being recognized are in
compliance with applicable water quality requirements and have a
satisfactory record with respect to environmental quality.
Municipalities and industries are recognized for their demonstrated
creativity and technological achievements in five awards categories as
follows:
    (1) Outstanding Operations and Maintenance practices at wastewater
treatment facilities;
    (2) Exemplary Biosolids Management projects, technology/innovation
or development activities, research and public acceptance efforts;
    (3) Pretreatment Program Excellence;
    (4) Storm Water Management Excellence; and,
    (5) Outstanding Combined Sewer Overflow Control programs. The
winners of the EPA's 2006 National Clean Water Act Recognition Awards
are listed below by category.

------------------------------------------------------------------------
                                              Sub-category
------------------------------------------------------------------------
   Category: Operations and
      Maintenance Awards
------------------------------------------------------------------------
First Place:
    Clean Water Services,      Large Advanced Plant.
     Rock Creek Advanced
     Wastewater Treatment
     Facility, Hillsboro, OR.
    Watertown Wastewater        Medium Advanced Plant.
     Treatment Facility,
     Watertown, SD.
    Town of Castleton          Small Advanced Plant.
     Wastewater Treatment
     Facility, Castleton, VT.
    Franklin Wastewater        Large Secondary Plant.
     Treatment Facility,
     Winnipesaukee River
     Basin Program, Franklin,
     NH.
    Huron Wastewater            Medium Secondary Plant.
     Treatment Facility,
     Huron, SD.
    Town of Wanatah             Small Secondary Plant.
     Wastewater Treatment
     Facility, Wanatah, IN.
    Sturgis Wastewater         Large Non-Discharging Plant.
     Treatment Facility,
     Sturgis, SD.
    Warner Village Water       Most Improved Plant.
     District, Warner, NH.
    New Hampshire Department   Trainer for the Most Improved Plant.
     of Environmental
     Services, Wastewater
     Engineering Bureau/
     Operations Section,
     Concord, New Hampshire.
Second Place:
    Littleton/Englewood        Large Advanced Plant.
     Wastewater Treatment
     Facility, Englewood, CO.
    The Pequannock Lincoln     Medium Advanced Plant.
     Park & Fairfield
     Sewerage Authority
     Wastewater Treatment
     Plant, Lincoln Park, NJ.
    Hurlburt Field Wastewater  Small Advanced Plant.
     Treatment Facility,
     Hurlburt Field Air Force
     Base, Okaloosa County,
     FL.
    Northern Water Pollution   Large Secondary Plant.
     Control Facility--Ocean
     County Utilities
     Authority, Brick
     Township, NJ.
    Portage Lake Water and     Medium Secondary Plant.
     Sewage Authority,
     Houghton-Hancock
     Wastewater Treatment
     Plant, Houghton, MI.
    City of Natoma Wastewater  Most Improved Plant.
     Treatment Facility,
     Natoma, KS.
    Gerald Grant, P.E., Fort   Trainer for the Most Improved Plant.
     Scott Community College,
     Fort Scott, KS.
------------------------------------------------------------------------
Category: Exemplary Biosolids
      Management Awards
------------------------------------------------------------------------
First Place:
    Encina Wastewater          Large Operating Projects.
     Authority, Biosolids
     Management Program,
     Carlsbad, CA.
    City of Olathe Compost     Small Operating Projects.
     Facility, Olathe, KS.
    Florida Water Environment  Public Acceptance Activities.
     Association and the
     Florida Dept. of
     Environmental Protection
     Agency/Central District,
     Orlando, FL.
Second Place:
    Rancho Las Virgenes        Public Acceptance Activities.
     Composting Facility,
     Community Compost
     Program, Calabasas, CA.
------------------------------------------------------------------------
    Category: Pretreatment
        Program Awards
------------------------------------------------------------------------
First Place:
    City of Corvallis          0-5 Significant Industrial Users (SIUs).
     Pretreatment Program,
     Corvallis, OR.
    Riverside Regional Water   6-20 SIUs.
     Quality Control Plant,
     Environmental Compliance
     Section, City of
     Riverside, CA.
    City of Fresno Industrial   Greater Than 21 SIUs.
     Pretreatment Program,
     Fresno, CA.
Second Place:
    City of San Leandro, San   6-20 SIUs.
     Leandro, CA.
------------------------------------------------------------------------
    Category: Storm Water
      Management Awards
------------------------------------------------------------------------
First Place:
    Santa Clara Valley Urban   Municipal Program.
     Runoff Pollution
     Prevention Program, San
     Jose, CA.
------------------------------------------------------------------------
   Category: Combined Sewer
   Overflow Control Awards
------------------------------------------------------------------------
First Place:
    Auburn Sewerage District,  Municipal Program.
     Auburn, ME.
Second Place:
    City of Little Falls       Municipal Program.
     Wastewater Treatment
     Plant, Little Falls NY.
------------------------------------------------------------------------

    Dated: November 16, 2006.
James A. Hanlon,
Director, Office of Wastewater Management.
 [FR Doc. E6-19750 Filed 11-21-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 92 (Thursday, May 12, 2011)]
[Notices]
[Pages 27704-27706]
[FR Doc No: 2011-11616]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64427; File No. SR-BX-2011-025]

Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of
Filing of Proposed Rule Change To Amend IM-4120-3 To Include Additional
Securities in the Pilot by Which Such Rule Operates and Amend Rule
4613(a) To Simplify Certain Aspects of the Text While Also Conforming
Certain of the Percentages Thereunder to the Proposed Changes to Price
Move Percentages That Trigger a Circuit Breaker Pilot Pause

May 6, 2011.
    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 May 4, 2011, NASDAQ OMX BX, Inc. (``Exchange''), 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 Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend IM-4120-3 to include additional
securities in the pilot by which such rule operates and amend Rule
4613(a) to simplify certain aspects of the text while also conforming
certain of the percentages thereunder to the proposed changes to price
move percentages that trigger a circuit breaker pilot pause.
    The text of the proposed rule change is below. Proposed new
language is italicized; proposed deletions are in brackets.
* * * * *

IM-4120-3. Circuit Breaker Securities Pilot

    The provisions of paragraph (a)(11) of this Rule shall be in
effect during a pilot set to end on the earlier of August 11, 2011
or the date on which a limit up/limit down mechanism to address
extraordinary market volatility, if adopted, applies. During the
pilot, the term ``Circuit Breaker Securities'' shall mean all NMS
stocks[the securities included in the S&P 500[supreg] Index, the
Russell 1000 Index, as well as a pilot list of Exchange Traded
Products].
* * * * *

4613. Market Maker Obligations

    A member registered as an Equities Market Maker shall engage in
a course of dealings for its own account to assist in the
maintenance, insofar as reasonably practicable, of fair and orderly
markets in accordance with this Rule.

(a) Quotation Requirements and Obligations

    (1) No change.
    (2) Pricing Obligations. For NMS stocks (as defined in Rule 600
under Regulation NMS) a Market Maker shall adhere to the pricing
obligations established by this Rule during Regular Trading Hours;
provided, however, that such pricing obligations (i) shall not
commence during any trading day until after the first regular way
transaction on the primary listing market in the security, as
reported by the responsible single plan processor, and (ii) shall be
suspended during a trading halt, suspension, or pause, and shall not
re-commence until after the first regular way transaction on the
primary listing market in the security following such halt,
suspension, or pause, as reported by the responsible single plan
processor.
    (A)-(C) No change.
    (D) For purposes of this Rule, the [term] ``Designated
Percentage'' shall be 8% for securities subject to Rule 4120(a)(11)
and are securities included in the S&P 500[supreg] Index, Russell
1000[supreg] Index, and a pilot list of Exchange Traded Products,
28% for securities subject to Rule 4120(a)(11) and that are all NMS
stocks not included in the S&P 500[supreg] Index, Russell
1000[supreg] Index, and a pilot list of Exchange Traded Products
with a price equal to or greater than $1, and 30% for securities
subject to Rule 4120(a)(11) and

that are all NMS stocks not included in the S&P 500[supreg] Index,
Russell 1000[supreg] Index, and a pilot list of Exchange Traded
Products with a price less than $1,[mean the individual stock pause
trigger percentage under Rule 4120(a)(11) (or comparable rule of
another exchange) less two (2) percentage points.] except that
between 9:30 a.m. and 9:45 a.m. and between 3:35 p.m. and the close
of trading, when Rule 4120(a)(11) is not in effect, the Designated
Percentage shall be 20% for securities included in the S&P
500[supreg] Index, Russell 1000[supreg] Index, and a pilot list of
Exchange Traded Products, 28% for all NMS stocks not included in the
S&P 500[supreg] Index, Russell 1000[supreg] Index, and a pilot list
of Exchange Traded Products with a price equal to or greater than
$1, and 30% for securities subject to Rule 4120(a)(11) and that are
all NMS stocks not included in the S&P 500[supreg] Index, Russell
1000[supreg] Index, and a pilot list of Exchange Traded Products
with a price less than $1. [For times during regular market hours
when stock pause triggers are not in effect under Rule 4120(a)(11)
(or comparable rule of another exchange), the Designated Percentage
calculation will assume a trigger percentage of 22%. For NMS stocks
that are not subject to such stock pause triggers the Designated
Percentage will assume a trigger percentage of 32%.]
    (E) For purposes of this Rule, the [term] ``Defined Limit''
shall be 9.5% for securities subject to Rule 4120(a)(11) and are
securities included in the S&P 500[supreg] Index, Russell
1000[supreg] Index, and a pilot list of Exchange Traded Products,
29.5% for securities subject to Rule 4120(a)(11) and that are all
NMS stocks not included in the S&P 500[supreg] Index, Russell
1000[supreg] Index, and a pilot list of Exchange Traded Products
with a price equal to or greater than $1, and 31.5% for securities
subject to Rule 4120(a)(11) and that are all NMS stocks not included
in the S&P 500[supreg] Index, Russell 1000[supreg] Index, and a
pilot list of Exchange Traded Products with a price less than
$1,[mean the individual stock pause trigger percentage under Rule
4120(a)(11) (or comparable rule of another exchange) less one-half
(\1/2\) percentage point.] except that between 9:30 a.m. and 9:45
a.m. and between 3:35 p.m. and the close of trading, when Rule
4120(a)(11) is not in effect, the Defined Limit shall be 21.5% for
securities included in the S&P 500[supreg] Index, Russell
1000[supreg] Index, and a pilot list of Exchange Traded Products,
29.5% for all NMS stocks not included in the S&P 500[supreg] Index,
Russell 1000[supreg] Index, and a pilot list of Exchange Traded
Products with a price equal to or greater than $1, and 31.5% for
securities subject to Rule 4120(a)(11) and that are all NMS stocks
not included in the S&P 500[supreg] Index, Russell 1000[supreg]
Index, and a pilot list of Exchange Traded Products with a price
less than $1. [For times during regular market hours when stock
pause triggers are not in effect under Rule 4120(a)(11) (or
comparable rule of another exchange), the Defined Limit calculation
will assume a trigger percentage of 22%. For NMS stocks that are not
subject to such stock pause triggers the Defined Limit calculation
will assume a trigger percentage of 32%.]
    (F)-(K) No change.
    (b)-(e) No change.
* * * * *

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

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

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

1. Purpose
    The Exchange proposes to amend IM-4120-3 to include additional
securities in the pilot by which such rule operates and amend Rule
4613(a) to simplify certain aspects of the text while also conforming
certain of the percentages thereunder to the proposed changes to price
move percentage triggers of the trading pause recognized under Rule
4120(a)(11).
    The Commission approved Rule 4120(a)(11) on a pilot basis on June
10, 2010 to provide for trading pauses in individual securities due to
extraordinary market volatility (``Trading Pause'') in all securities
included within the S&P 500[supreg] Index (``S&P 500'') (``Trading
Pause Pilot'' or ``Pilot'').\3\ The Exchange noted in its filing to
adopt Rule 4120(a)(11) that during the Pilot period it would continue
to assess whether additional securities need to be added and whether
the parameters of Rule 4120(a)(11) would need to be modified to
accommodate trading characteristics of different securities. The
Exchange subsequently received approval to add to the Pilot the
securities included in the Russell 1000[supreg] Index (``Russell
1000'') and a specified list of Exchange Traded Products (``ETPs'').\4\
---------------------------------------------------------------------------

    \3\ The Commission approved the Trading Pause Pilot for all
equities exchanges and FINRA. See Securities Exchange Act Release
No. 62252 (June 10, 2010), 75 FR 34186 (June 16, 2010) (File Nos.
SR-BATS-2010-014; SR-EDGA-2010-01; SR-EDGX-2010-01; SR-BX-2010-037;
SR-ISE-2010-48; SR-NYSE-2010-39; SR-NYSEAmex-2010-46; SR-NYSEArca-
2010-41; SR-NASDAQ-2010-061; SR-CHX-2010-10; SR-NSX-2010-05; and SR-
CBOE-2010-047) and Securities Exchange Act Release No. 62251 (June
10, 2010), 75 FR 34183 (June 16, 2010) (SR-FINRA-2010-025).
    \4\ The Commission approved the addition to the Trading Pause
Pilot of the securities included in the Russell 1000 and ETPs, where
applicable, for all equities exchanges and FINRA. See Securities
Exchange Act Release No. 62884 (September 10, 2010), 75 FR 56618
(September 16, 2010) (File Nos. SR-BATS-2010-018; SR-BX-2010-044;
SR-CBOE-2010-065; SR-CHX-2010-14; SR-EDGA-2010-05; SR-EDGX-2010-05;
SR-ISE-2010-66; SR-NASDAQ-2010-079; SR-NYSE-2010-49; SR-NYSEAmex-
2010-63; SR-NYSEArca-2010-61; and SR-NSX-2010-08 and Securities
Exchange Act Release No. 62883 (September 10, 2010), 75 FR 56608
(September 16, 2010) (SR-FINRA-2010-033). The Exchange submitted a
proposed rule change shortly after the addition of the Russell 1000
securities and ETPs to extend the operation of the Pilot, which was
set to expire on December 10, 2010, until April 11, 2011. See
Securities Exchange Act Release No. 63505 (December 9, 2010), 75 FR
78302 (December 15, 2010) (SR-NASDAQ-2010-162). On March 31, 2011,
the Exchange submitted a proposed rule change to further extend the
pilot program until the earlier of August 11, 2011 or the date on
which a limit up/limit down mechanism to address extraordinary
market volatility, if adopted, applies. See Securities Exchange Act
Release No. 64176 (April 4, 2011), 76 FR 19821 (April 8, 2011) (SR-
BX-2011-018).
---------------------------------------------------------------------------

    The Exchanges have continued to assess whether additional
securities need to be added to the Pilot and whether the parameters of
the Pilot needs to be modified to accommodate trading characteristics
of different securities. In consultation with other markets and the
staff of the Commission, the Exchanges are proposing to include all NMS
stocks within the Pilot that are not already included therein, but to
apply a wider price move percentage to the newly added securities.\5\
Accordingly, the Exchange proposes to delete language concerning the
limited application of pauses in Circuit Breaker Securities from the
rule's text, as the text therein would no longer be necessary, and to
define Circuit Breaker Securities as all NMS stocks.
---------------------------------------------------------------------------

    \5\ Certain of the Exchanges that have market maker requirements
are modifying their market maker obligations to fit within these new
Pilot price move percentages.
---------------------------------------------------------------------------

    The NYSE, NYSE Amex, NYSE Arca, and NASDAQ, as the listing markets,
are proposing to set the price move required to trigger a trading pause
for the proposed new securities to be 30% or more for such securities
priced at $1 or higher and 50% or more for such securities priced less
than $1.\6\ The listing markets believe that applying a broader
percentage to securities priced less than $1 compared to those priced
above $1 is appropriate given that lower-priced securities tend to be
more volatile, and price movements of lower-priced securities equate to
a higher percentage move than a similar price change for a higher-
priced security. The listing markets also believe that these
percentages are commensurate with the

characteristics shared by the proposed new securities within these
price ranges and would promote the objectives of the Trading Pause
Pilot to reduce the negative impacts of unanticipated price movements
in a security. In particular, the proposed additional stocks are those
not currently included in the S&P 500 Index, Russell 1000 Index, or
specified ETPs, and therefore are more likely to be less liquid
securities or securities with lower trading volumes. Accordingly, the
Exchange believes that broader price move percentages would be
appropriate. Similarly, because leveraged ETPs trade at a ratio against
the associated index, a broader price move percentage would also be
appropriate for leveraged ETPs.
---------------------------------------------------------------------------

    \6\ Under the proposed rule change, the price of a security
would be based on the closing price on the previous trading day, or,
if no closing price exists, the last sale reported to the
Consolidated Tape on the previous trading day.
---------------------------------------------------------------------------

    The proposed changes to the Pilot, if approved, would require that
the text of Rule 4613(a), which pertains to the pricing obligations
that Market Makers are required to adhere to, be amended to correct the
cross-references therein to Rule 4120(a)(11) and the price move
thereunder. Specifically, the Exchange proposes to remove any text from
Rule 4613(a) addressing NMS stocks that are not subject to the Pilot
because no such securities would exist and such text would therefore be
unnecessary. The Exchange also proposes to simplify Rule 4613(a) by
explicitly stating the percentages that are applicable thereunder and
the times during the trading day when Rule 4120(a)(11) is not in
effect. The Exchange notes that part of this proposed change would be
substantive, in that the percentages under Rule 4613(a) would decrease
slightly for the proposed new securities priced at $1 or greater. The
Exchange believes that this proposed substantive change would not have
a significant impact on Market Maker pricing obligations and is
reasonable because it would ensure that the designated quoting
percentages in Rule 4613(a) are within a narrower range than the
percentages necessary to trigger a Trading Pause.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\7\ in general, and furthers the objectives of Section
6(b)(5),\8\ in particular, in that it is designed 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 facilitating transactions in securities, and to
remove impediments to and perfect the mechanism of a free and open
market and a national market system. The proposed rule change also is
designed to support the principles of Section 11A(a)(1) \9\ of the Act
in that it seeks to ensure fair competition among brokers and dealers
and among exchange markets. The Exchange believes that the proposed
rule meets these requirements because it expands the scope of the Pilot
to cover all NMS stocks. Additionally, the proposed changes would
ensure that the designated quoting percentages in Rule 4613(a) are
within a narrower range than the percentages necessary to trigger a
Trading Pause.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
    \9\ 15 U.S.C. 78k-1(a)(1).
---------------------------------------------------------------------------

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

    The Exchange 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.

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

    Written comments were neither solicited nor received.

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

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-BX-2011-025 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-2011-025. This file
number should be included on the subject line if e-mail 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
a.m. and 3 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 publicly available. All
submissions should refer to File Number SR-BX-2011-025 and should be
submitted on or before June 2, 2011.
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
---------------------------------------------------------------------------
pursuant to delegated authority.\10\

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-11616 Filed 5-11-11; 8:45 am]
BILLING CODE 8011-01-P


Docket ID #:  EPA-HQ-OPP-2010-0916

COMPANY NOTICE OF FILING FOR HEXYTHIAZOX TOLERANCE PETITION

EPA Registration Division contact: Sidney Jackson,<PHONE_NUMBER>

Interregional Research Project Number 4 (IR-4) and Gowan Company

PP# 0E7787

.448, by establishing a tolerance for residues of hexythiazox
(trans-5-(4-chlorophenyl)-N-cyclohexyl-4-methyl-2-oxothiazolidine-3-carb
oxamide) and its metabolites containing the
(4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety in or on tomato at
0.50 parts per million (ppm). 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 of the petition.  Additional data may be needed before
EPA rules on the petition.

Plant metabolism. The nature of the residues in plants is adequately
understood for purposes of this tolerance.  Metabolism studies in fruit
crops, radish and tea have been previously reviewed by the Agency.  The
Agency has determined that the residues of concern are hexythiazox and
its metabolites containing the
(4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety.  The results of a
new corn metabolism study (MRID   48081501, currently in review) are
consistent with the other plant metabolism data.

Analytical method. A practical analytical method, high pressure liquid
chromatography with a UV detector, which detects and measures residues
of hexythiazox and its metabolites as a common moiety, is available for
enforcement purposes with a limit of detection that allows monitoring of
food with residues at or above the levels set in this tolerance.

Magnitude of residues. Five new greenhouse trials were conducted by IR4
in support of the proposal to add greenhouse tomatoes to the label.
The results of these new trials support the proposed tolerance levels of
0.50 ppm.

Magnitude of the Residue in Processed Food/Feed.  Tomatoes grown in
greenhouses are intended for the fresh market, not for processing
commodities.  Processing studies are not required. Greenhouse tomatoes
are not rotated to other crops.

Acute toxicity. A battery of acute toxicity studies places technical
grade hexythiazox in Toxicity Category IV for acute oral LD50 (LD50 >
5,000 milligram/kilograms (mg/kg)), Category III for dermal LD50 (LD50
>5,000 mg/kg), Category III for inhalation LC50 (LC50 >2.0 mg/L),
Category III for primary eye irritation (showed mild irritation
(reddened conjunctiva)), Category IV for dermal irritation (non
irritant). Hexythiazox is a non-sensitizer.  Acute toxicological studies
place technical grade hexythiazox in Toxicology Category III.

Genotoxicty. The following genotoxicity studies were all negative: Ames
gene mutation, CHO gene mutation, CHO chromosome aberration, mouse
micronucleus and rat hepatocyte unscheduled DNA synthesis.

Reproductive and developmental toxicity.  In a developmental toxicity
study in rats, the maternal No-Adverse-Effect-Level (NOAEL) was 240
mg/kg/day and the maternal Lowest-Adverse-Effect-Level (LOAEL) was 720
mg/kg/day based on increased ovarian weights and decreased bone
ossification. In a developmental toxicity study in rabbits, the maternal
NOAEL was 1,080 mg/kg/day (HDT); the maternal LOAEL was not determined.
The developmental NOAEL was 1,080 mg/kg/day (HDT); the developmental
LOAEL was not determined.  In a 2-generation reproduction study in rats,
the parental NOAEL was 35 mg/kg/day and the parental LOAEL was 200
mg/kg/day based on decreased body weight gain, decreased food
consumption and efficiency, and increased liver, kidney and ovarian
weights. The reproductive NOAEL was 35 mg/kg/day and the reproductive
LOAEL was 200 mg/kg/day based on decreased pup bwt during lactation,
delayed hair growth and eye opening.

Subchronic toxicity. In a 1-month feeding study in dogs, the NOAEL was
1.75 mg/kg/day and the LOAEL was 12.5 mg/kg/day, based on increased
liver and adrenal weights.

Chronic toxicity. In a 1-year feeding study in dogs, the NOAEL was 2.5
mg/kg/day and the LOAEL was 12.5 mg/kg/day, based on increased alkaline
phosphatase, increased adrenal and liver weights, and liver and adrenal
lesions.   In a carcinogenicity study in mice, the NOAEL was 36
mg/kg/day and the LOAEL was 215 mg/kg/day. Effects were decreased
bodyweight in males and increased hepatocellular carcinomas and combined
adenoma/carcinomas.

In a chronic feeding/carcinogenicity study in rats, the NOAEL (systemic)
was 26 mg/kg/day and the LOAEL (systemic) was 180 mg/kg/day based on
decreased body weight gain and increased liver weights in both sexes.

A 2009 report from the EPA Cancer Assessment Review Committee (CARC)
(September 02,2009,PC Code 128849, TXR 0055255) noted that the NOAEL of
2.5 mg/kg/day, from the one year toxicity study in dogs, used in
establishing the chronic reference dose (RfD) is approximately 65-fold
lower than the lowest dose (163 mg/kg/day) that induced tumors. Thus,
the chronic RfD of 0.025 mg/kg/day would be protective of all chronic
effects including potential carcinogenicity of hexythiazox.  The CARC
concluded that the evidence as a whole was not strong enough to warrant
the use of a linear low dose extrapolation model applied to the animal
data (Q1*) for a quantitative estimation of human risk, as had been
previously assessed in October 16, 1998, [63.FR55540].

Animal metabolism. The metabolism of hexythiazox has been studied in
goats, hens and rats. Metabolic pathways in the animal are similar to
those in plants.

Metabolic toxicology.  EPA has previously determined that the residues
of concern in plant and animal commodities are hexythiazox and its
metabolite containing the (4 chlorophenyl)-4-methyl-2oxo-3-thiazolidine
moiety.

Endocrine disruptions.  No specific test have been conducted with
hexythiazox to determine whether the chemical may have any effect in
humans that is similar to an effect produced by a naturally ocurring
estrogen or other endocrine effects.  However, there were no significant
findings in other relevant toxicity tests, i.e., teratology and
multi-generational reproduction studies, which would suggest that
hexythiazox produces effects characteristic of the disruptions of
hormones.

Dietary Exposure from food. A dietary risk assessment for all registered
crops has been recently completed by the Agency (July 14, 2010,
75FR40741).

Acute Exposure.  No acute endpoint has been identified in the
toxicological studies for hexythiazox; therefore, a quantitative acute
dietary exposure assessment is unnecessary.

Chronic Exposure. A tier 1 chronic risk assessment indicates that the
proposed use results in an incremental additional dietary risk of not
more than 8% of the chronic Population Adjusted Dose (cPAD) for any
population subgroup. The registrant has concluded that hexythiazox use
in greenhouse tomatoes will not significantly contribute to dietary
exposure.

Cancer.   The Agency has previously determined that the chronic
reference dose is sufficient to evaluate all chronic risk of
hexythiazox, including carcinogenic potential.

Dietary Exposure from drinking water. The Agency used screening level
water exposure models in the dietary exposure analysis and risk
assessment for hexythiazox in drinking water.  Based on the Pesticide
Root Zone Model /Exposure Analysis Modeling System (PRZM/EXAMS) the
estimated drinking water concentration (EDWC) of hexythiazox for chronic
exposures for non-cancer and cancer assessments is estimated to be 4.1
parts per billion (ppb) for surface water. Since surface water residue
values greatly exceed groundwater EDWCs, surface water residues were
used in the dietary risk assessment (July 14, 2010 75FR40741).

From non-dietary exposure. EPA has conducted a residential risk
assessment to support recently approved uses on turf, ornamental
landscape plantings, ornamental plants, orchids and residential fruit
trees, nut trees and caneberries. The Agency concludes that there are no
residential risks of concern associated with these uses (January 28,
2010 EPA Memo. PR Code: 128849, DP Barcode D372889.)

EPA has not determined whether hexythiazox has a common mechanism of
toxicity with other substances or how to include this pesticide in a
cumulative risk assessment.  Unlike other pesticides for which EPA has
followed a cumulative risk approach based on a common mechanism of
toxicity, hexythiazox does not share a toxic metabolite with other
substances.  For the purposes of this tolerance action, therefore, the
registrant has not assumed that hexythiazox has a common mechanism of
toxicity with other substances.  For purposes of this petition the
potential risks of hexythiazox in its aggregate exposure only will be
considered.

1. US population

Acute risk.  No adverse effect resulting from a single oral exposure to
hexythiazox has been identified, thus hexythiazox is not expected to
pose an acute risk.

Short-and intermediate term risk. EPA has concluded the combined
short-term food, water, and residential exposures result in aggregate
MOEs of 16,000 for adults and 2,000 for children. Because EPA's level of
concern for hexythiazox is a MOE of 100 or below, these MOEs are not of
concern.

Chronic risk.  EPA previously concluded in the July 14, 2010, 75FR40741
that chronic exposure to hexythiazox from food and water will utilize no
more than 49% of the cPAD for  the population group receiving the
greatest exposure (children 1-2 years old).   The current assessment
evaluated all registered crops, pending tolerance actions and the
proposed new tolerance for tomatoes. This assessment utilized the
proposed tolerance value for tomatoes, assumed 100% crop treated and
utilized default processing factors.  The additional potential dietary
exposure associated with the proposed use, using a conservative Tier 1
assessment for all tomatoes, not just limited to greenhouse grown
tomatoes, will now utilize 57% of the cPAD.  Actual exposure will be
considerably less. Chronic residential exposure to residues of
hexythiazox is not expected.

Cancer risk.  As discussed in the Federal Register of March 17, 2010,
(75 FR 12691), EPA concluded that regulation based on the chronic
reference dose will be protective for both chronic and carcinogenic
risks. There are no chronic risks of concern.

Infants and Children.  Based on these risk assessments, it can be
concluded that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to hexythiazox residues.

According to the Codex alimentarius website
(http://www.codexalimentarius.net/mrls/) a 0.1 ppm MRL has been
established by Codex.

 PAGE  5

{</HD2>}

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{
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{<HD2>}

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{
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{
}

{
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{</HD2>}

{<HD2>}

{</HD2>}

{
}


[Federal Register Volume 75, Number 220 (Tuesday, November 16, 2010)]
[Proposed Rules]
[Pages 69909-69910]
[FR Doc No: 2010-28660]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2005-TX-0012; FRL-9226-3]

Approval and Promulgation of Implementation Plans; Texas;
Emissions Banking and Trading of Allowances Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: EPA is proposing to approve portions of four revisions to the
Texas State Implementation Plan (SIP) that create and amend the
Emissions Banking and Trading of Allowances (EBTA) Program. The EBTA
Program establishes a cap and trade program to reduce emissions of
oxides of nitrogen (NOX) and sulfur dioxide (SO2)
from participating electric generating facilities. The Texas Commission
on Environmental Quality (TCEQ) originally submitted the EBTA program
to EPA as a SIP revision on January 3, 2000. Since that time, the TCEQ
has submitted SIP revisions for the EBTA Program on September 11, 2000;
July 15, 2002; and October 24, 2006. EPA has determined that these
changes to the Texas SIP comply with the Federal Clean Air Act (the Act
or CAA) and EPA regulations, are consistent with EPA policies, and will
improve air quality. This action is being taken under section 110 and
parts C and D of the Act.

DATES: Comments must be received on or before December 16, 2010.

ADDRESSES: Comments may be mailed to Mr. Jeff Robinson, Chief, Air
Permits Section (6PD-R), Environmental Protection Agency, 1445 Ross
Avenue, Suite 1200, Dallas, Texas 75202-2733. Comments may also be
submitted electronically or through hand delivery/courier by following
the detailed instructions in the ADDRESSES section of the direct final
rule located in the rules section of this Federal Register.

FOR FURTHER INFORMATION CONTACT: If you have questions concerning
today's proposal, please contact Ms. Adina Wiley (6PD-R), Air Permits
Section, Environmental Protection Agency, Region 6, 1445 Ross Avenue
(6PD-R),

Suite 1200, Dallas, TX 75202-2733. The telephone number is (214) 665-
2115. Ms. Wiley can also be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the final rules section of this Federal
Register, EPA is approving the State's SIP submittal as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no relevant adverse
comments. A detailed rationale for the approval is set forth in the
direct final rule. If no relevant adverse comments are received in
response to this action, no further activity is contemplated. If EPA
receives relevant adverse comments, the direct final rule will be
withdrawn and all public comments received will be addressed in a
subsequent final rule based on this proposed rule. EPA will not
institute a second comment period. Any parties interested in commenting
on this action should do so at this time. Please note that if EPA
receives adverse comment on an amendment, paragraph, or section of the
rule, and if that provision may be severed from the remainder of the
rule, EPA may adopt as final those provisions of the rule that are not
the subject of an adverse comment.
    For additional information, see the direct final rule which is
located in the rules section of this Federal Register.

    Dated: November 5, 2010.
Lawrence E. Starfield,
Acting Regional Administrator, Region 6.
[FR Doc. 2010-28660 Filed 11-15-10; 8:45 am]
BILLING CODE 6560-50-P