[Federal Register Volume 77, Number 182 (Wednesday, September 19, 2012)]
[Notices]
[Pages 58121-58122]
[FR Doc No: 2012-23079]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP12-1029-000.
    Applicants: Dogwood Energy LLC, Unified Government of Wyandotte
County/K.
    Description: Request for Temporary Waiver of Dogwood Energy LLC and
Unified Government of Wyandotte County/Kansas City, Kansas.
    Filed Date: 9/7/12.
    Accession Number: 20120907-5145.
    Comments Due: 5 p.m. e.t. 9/19/12.

    Docket Numbers: RP12-1032-000.
    Applicants: CenterPoint Energy Gas Transmission Comp.
    Description: CEGT LLC--Negotiated Rate Filing--September 2012 to be
effective 9/10/2012.
    Filed Date: 9/12/12.

    Accession Number: 20120912-5122.
    Comments Due: 5 p.m. e.t. 9/24/12.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP12-900-001.
    Applicants: Sea Robin Pipeline Company, LLC.
    Description: Compliance with RP12-900-000.
    Filed Date: 9/12/12.
    Accession Number: 20120912-5027.
    Comments Due: 5 p.m. e.t. 9/24/12.

    Any person desiring to protest in any of the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5 p.m. Eastern time on the specified comment
date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, and service can be found at:
http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other
information, call<PHONE_NUMBER> (toll free). For TTY, call (202) 502-
8659.

    Dated: September 13, 2012.
Nathaniel J. Davis, Sr.
Deputy Secretary.
[FR Doc. 2012-23079 Filed 9-18-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 45 (Tuesday, March 8, 2011)]
[Notices]
[Pages 12742-12743]
[FR Doc No: 2011-5148]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0457]

Guidance for Industry and Food and Drug Administration Staff;
Clinical Investigations of Devices Indicated for the Treatment of
Urinary Incontinence; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Clinical Investigations of
Devices Indicated for the Treatment of Urinary Incontinence.'' This
guidance document describes FDA's recommendations for clinical
investigations of medical devices indicated for the treatment of
urinary incontinence.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.

ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Clinical Investigations of Devices Indicated for
the Treatment of Urinary Incontinence '' to the Division of Small
Manufacturers, International, and Consumer Assistance, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request, or fax your request to<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: John Baxley, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. G210, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Urinary incontinence is defined as the involuntary loss of urine.
This guidance is intended to assist device manufacturers who plan to
conduct clinical investigations of devices intended to treat urinary
incontinence in support of premarket approval (PMA) applications or
premarket notification (510(k)) submissions. The guidance describes
FDA's recommendations for human clinical trials that involve the use of
any type of urinary incontinence

device, including, but not limited to, implanted electrical urinary
continence devices; implanted mechanical/hydraulic urinary continence
devices; urological clamp for males; nonimplanted, peripheral and other
electrical continence devices; protective garment for incontinence;
surgical mesh; electrosurgical cutting and coagulation device and
accessories; perineometer; gynecologic laparoscope and accessories; and
vaginal pessary.
    In the Federal Register of September 19, 2008 (73 FR 54406), FDA
announced the availability of the draft guidance. Comments on the draft
guidance were due by December 18, 2008. Two comments were received with
each comment making multiple recommendations on changes to the content
of the guidance document.
    The comments included recommended changes to or removals of
primary, secondary, and composite endpoints and changes to the
recommended clinical study design. In response to these comments, FDA
has clarified the appropriate context for recommended endpoints and a
sponsor's options with respect to use of a given endpoint. FDA also
revised the recommended requirements for use of voiding diaries and
clarified the recommendation regarding the randomization of subjects.
    Comments also involved recommendations on the categorization of
adverse events. In response to these comments, FDA clarified the
recommendation for categorization of adverse events as either device-
or procedure-related.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on clinical investigations of devices
intended to treat urinary incontinence. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
using the Internet. A search capability for all CDRH guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. To receive
``Clinical Investigations of Devices Indicated for the Treatment of
Urinary Incontinence,'' you may either send an e-mail request to
<EMAIL_ADDRESS>to receive an electronic copy of the document or
send a fax request to<PHONE_NUMBER> to receive a hard copy. Please use
the document number 1636 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 812 have been approved under
OMB control number 0910-0078; the collections of information in 21 CFR
part 807, subpart E, have been approved under OMB control number 0910-
0120; the collections of information in 21 CFR part 814 have been
approved under OMB control number 0910-0231; and the collections of
information in 21 CFR parts 50.23 and 56.115 have been approved under
OMB control number 0910-0130.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5148 Filed 3-7-11; 8:45 am]
BILLING CODE 4160-01-P


Memorandum from Ashley L. Allen ( U. S. Environmental Protection Agency, Office of Water), to EPA Docket OW 2004 0002.

Consideration of an Analysis of Distribution and Magnitude of Fish Egg Densities in the Gulf of Mexico.

November 2005 The Southeast Area Monitoring and Assessment Program ( SEAMAP) ( see www. gsmfc. org for additional information) conducts extensive monitoring of ichthyoplankton throughout the Gulf of Mexico. A memo describing an analysis of the magnitude and distribution of fish larvae densities has been placed in EPA Docket OW 2004 0002 ( see " A Summary of Ichthyoplankton Presence and Abundance in the Gulf of Mexico, as Part of an Assessment of the Potential for Entrainment by Offshore Oil and Gas Facilities"). SEAMAP's monitoring data for fish eggs has also been placed in EPA Docket OW 2004 0002 ( see " ICHSTRWK_ 09_ 02_ 2004")). EPA will consider conducting an analysis of the distribution and magnitude of fish egg densities in the Gulf of Mexico very similar to the analysis conducted for fish larvae.


[Federal Register Volume 88, Number 97 (Friday, May 19, 2023)]
[Notices]
[Pages 32274-32275]
[FR Doc No: 2023-10702]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2021-0092; Notice 2]

Volkswagen Group of America, Inc., Grant of Petition for Decision
of Inconsequential Noncompliance

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Grant of petition.

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SUMMARY: Volkswagen Group of America, Inc., (Volkswagen), has
determined that certain model year (MY) 2021-2022 Volkswagen and Audi
motor vehicles do not fully comply with Federal Motor Vehicle Safety
Standard (FMVSS) No. 208, Occupant Crash Protection. Volkswagen filed
an original noncompliance report dated November 19, 2021, and later
amended the report on November 22, 2021, and December 1, 2021.
Volkswagen petitioned NHTSA on December 13, 2021, for a decision that
the subject noncompliance is inconsequential as it relates to motor
vehicle safety. This document announces the grant of Volkswagen's
petition.

FOR FURTHER INFORMATION CONTACT: Syed Rahaman, General Engineer, NHTSA,
Office of Vehicle Safety Compliance,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    I. Overview: Volkswagen has determined that certain MY 2021-2022
Volkswagen and Audi motor vehicles do not fully comply with paragraphs
S4.5.1(f)(1), S4.5.1(f)(2)(ii), and S4.5.1(f)(2)(vii) of FMVSS No. 208,
Occupant Crash Protection (49 CFR 571.208).
    Volkswagen filed an original noncompliance report dated November
19, 2021, and later amended the report on November 22, 2021, and
December 1, 2021, pursuant to 49 CFR part 573, Defect and Noncompliance
Responsibility and Reports. Volkswagen petitioned NHTSA on December 13,
2021, for an exemption from the notification and remedy requirements of
49 U.S.C. Chapter 301 on the basis that this noncompliance is
inconsequential as it relates to motor vehicle safety, pursuant to 49
U.S.C. 30118(d) and 30120(h) and 49 CFR part 556, Exemption for
Inconsequential Defect or Noncompliance.
    Notice of receipt of Volkswagen's petition was published with a 30-
day public comment period, on March 14, 2022, in the Federal Register
(87 FR 14322). No comments were received. To view the petition and all
supporting documents log onto the Federal Docket Management System
(FDMS) website at https://www.regulations.gov/. Then follow the online
search instructions to locate docket number ``NHTSA-2021-0092.''
    II. Vehicles Involved: Approximately 48,948 of the following
vehicles, manufactured between July 30, 2020, and November 18, 2021,
are potentially involved:

 MY 2022 Volkswagen Taos
 MY 2021 Volkswagen ID.4
 MY 2022 Volkswagen Golf R A8
 MY 2022 Volkswagen Golf GTI
 MY 2022 Audi S3 Sedan
 MY 2022 Audi A3 Sedan

    III. Noncompliance: Volkswagen explains that the owner's manual for
the subject vehicles incorrectly states the length of time the
``Passenger Air Bag On'' light is illuminated while the air bag is
active and therefore, does not meet the requirements of paragraphs
S4.5.1(f)(1), S4.5.1(f)(2)(ii), and S4.5.1(f)(2)(vii) of FMVSS No. 208.
Specifically, when the air bag is activated, the ``Passenger Air Bag
On'' light will blink for 5 seconds, remain illuminated for 60 seconds,
and then go out. However, the owner's manual inaccurately states that
the light will remain illuminated permanently when the air bag is on.
    IV. Rule Requirements: Paragraphs S4.5.1(f)(1), S4.5.1(f)(2)(ii),
and S4.5.1(f)(2)(vii) of FMVSS No. 208 include the requirements
relevant to this petition. The owner's manual for any vehicle equipped
with an inflatable restraint system shall include an accurate
description of the vehicle's air bag system in an easily understandable
format. The manufacturer is required to include in the vehicle owner's
manual a discussion of the advanced passenger air bag system installed
in the vehicle. The discussion must explain the proper functioning of
the advanced air bag system and provide a summary of the actions that
may affect the proper functioning of the system. The discussion shall
include accurate information on (1) an explanation of how the
components function together as part of the advanced passenger air bag
system and (2) a discussion of the telltale light, specifying its
location in the vehicle and explaining when the light is illuminated.
    V. Summary of Volkswagen's Petition: The following views and
arguments presented in this section, ``V. Summary of Volkswagen's
Petition,'' are the views and arguments provided by Volkswagen. They do
not reflect the views of the Agency. Volkswagen

describes the subject noncompliance and contends that the noncompliance
is inconsequential as it relates to motor vehicle safety.
    Volkswagen says that although the owner's manual does not
accurately state the duration of time that the ``Passenger Air Bag On''
light is illuminated, the light ``is neither required nor regulated''
by FMVSS No. 208. Volkswagen contends that although the light does not
remain illuminated, the ``system itself is switched on, is ready to
function, and is otherwise accurately described within the owner's
manual.''
    Volkswagen explains that the owner's manual for the subject
vehicles ``provides an explanation of how the system's components
function together, as well as how the ``Passenger Air Bag Off'' light
functions,'' as required by FMVSS No. 208. Volkswagen further explains
that the owner's manual also provides ``a presentation and explanation
of the main components of the advanced passenger air bag system, an
explanation of how the components function, and the basic requirements
for proper operations, among other important relevant safety
information.''
    Volkswagen notes that it has corrected the noncompliance for
vehicles still in its control by adding a supplemental page with the
accurate information into the owner's manual.
    Volkswagen states that it is aware of one customer inquiry related
to the subject noncompliance which has been resolved but is not aware
of any accidents or injuries that have occurred as a result of the
subject noncompliance.
    Volkswagen concludes by stating its belief that the subject
noncompliance is inconsequential as it relates to motor vehicle safety
and its petition to be exempted from providing notification of the
noncompliance, as required by 49 U.S.C. 30118, and a remedy for the
noncompliance, as required by 49 U.S.C. 30120, should be granted.
    VI. NHTSA's Analysis: In determining inconsequentiality of a
noncompliance, NHTSA focuses on the safety risk to individuals who
experience the type of event against which a recall would otherwise
protect.\1\ In general, NHTSA does not consider the absence of
complaints or injuries when determining if a noncompliance is
inconsequential to safety. The absence of complaints does not mean
vehicle occupants have not experienced a safety issue, nor does it mean
that there will not be safety issues in the future.\2\
---------------------------------------------------------------------------

    \1\ See Gen. Motors, LLC; Grant of Petition for Decision of
Inconsequential Noncompliance, 78 FR 35355 (June 12, 2013) (finding
noncompliance had no effect on occupant safety because it had no
effect on the proper operation of the occupant classification system
and the correct deployment of an air bag); Osram Sylvania Prods.
Inc.; Grant of Petition for Decision of Inconsequential
Noncompliance, 78 FR 46000 (July 30, 2013) (finding occupant using
noncompliant light source would not be exposed to significantly
greater risk than occupant using similar compliant light source).
    \2\ See Morgan 3 Wheeler Limited; Denial of Petition for
Decision of Inconsequential Noncompliance, 81 FR 21663, 21666 (Apr.
12, 2016); see also United States v. Gen. Motors Corp., 565 F.2d
754, 759 (D.C. Cir. 1977) (finding defect poses an unreasonable risk
when it ``results in hazards as potentially dangerous as sudden
engine fire, and where there is no dispute that at least some such
hazards, in this case fires, can definitely be expected to occur in
the future'').
---------------------------------------------------------------------------

    NHTSA agrees with Volkswagen that the Passenger Air Bag On
indicator is not required by FMVSS No. 208. The Passenger Air Bag Off
indicator is required by FMVSS No. 208 and appears to meet the
requirements, i.e., it remains illuminated and its functionality is
described accurately in the owner's manual.
    As Volkswagen has stated, the vehicle itself functions as intended
for both the On and Off indicators. If Volkswagen had not implemented
the On indicator and had no owner's manual information for the On
indicator, there would not be a noncompliance. Further, if such a
situation existed, there would be no degradation to safety as it
relates to the FMVSSs.
    If the air bag was inactive, by either the vehicle determining air
bag suppression is necessary or by the seat being unoccupied, the Off
indicator would then illuminate and remain illuminated. This provides
clear communication to the vehicle occupants.
    The disparity between the behavior of the On indicator and the
description of its operation in the vehicle owner's manual may cause
confusion to owners who carefully review that document as it could lead
them to the belief that the air bag is not in an On condition when in
fact it is. While the existence of this disparity is a matter of
concern and may have customer satisfaction consequences for the
manufacturer, NHTSA does not find that a safety consequence exists in
this case.
    NHTSA has evaluated the merits of the inconsequential noncompliance
petition submitted by Volkswagen and has determined that this
particular noncompliance is inconsequential to motor vehicle safety.
The inaccurate owner's manual description for the non-required
Passenger Air Bag On indicator is inconsequential to the safety of the
vehicles listed above. This does not imply that all inaccurate owner's
manual descriptions would be considered inconsequential, but rather
NHTSA agrees that this particular case is inconsequential.
    VII. NHTSA's Decision: In consideration of the foregoing, NHTSA
finds that Volkswagen has met its burden of persuasion that the subject
FMVSS No. 208 noncompliance in the affected vehicles is inconsequential
to motor vehicle safety. Accordingly, Volkswagen's petition is hereby
granted, and Volkswagen is consequently exempted from the obligation of
providing notification of, and a free remedy for, that noncompliance
under 49 U.S.C. 30118 and 30120.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, this decision
only applies to the subject vehicles that Volkswagen no longer
controlled at the time it determined that the noncompliance existed.
However, the granting of this petition does not relieve vehicle
distributors and dealers of the prohibitions on the sale, offer for
sale, or introduction or delivery for introduction into interstate
commerce of the noncompliant vehicles under their control after
Volkswagen notified them that the subject noncompliance existed.

(Authority: 49 U.S.C. 30118, 30120: delegations of authority at 49
CFR 1.95 and 501.8)

Otto G. Matheke III,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2023-10702 Filed 5-18-23; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 77, Number 151 (Monday, August 6, 2012)]
[Notices]
[Pages 46778-46781]
[FR Doc No: 2012-19082]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67546; File No. SR-BOX-2012-010]

Self-Regulatory Organizations; BOX Options Exchange LLC; Notice
of Filing and Immediate Effectiveness of Proposed Rule Change To Amend
the Fee Schedule for Trading on BOX

July 31, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'' or ``Exchange Act'') \1\ and Rule 19b-4 thereunder,\2\ notice
is hereby given that on July 27, 2012, BOX Options Exchange LLC (the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II
and III below, which Items have been prepared by the Exchange. The
Exchange filed the proposed rule change pursuant to Section
19(b)(3)(A)(ii) of the Act,\3\ and Rule 19b-4(f)(2) thereunder,\4\
which renders the proposal effective upon filing with the Commission.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    BOX Options Exchange LLC (the ``Exchange'') proposes to amend its
Fee Schedule for trading on its options facility, BOX Market LLC
(``BOX''). While changes to the fee schedule pursuant to this proposal
will be effective upon filing, the changes will become operative on
August 1, 2012. The text of the proposed rule change is available from
the principal office of the Exchange, on the Exchange's Internet Web
site at http://boxexchange.com, and at the Commission's Public
Reference Room.

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

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

forth in Sections A, B, and C below, of the most significant aspects of
such statements.

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

1. Purpose
    The Exchange proposes to implement a change to the BOX routing fees
in Section III of the fee schedule. BOX believes the proposed structure
will continue to provide an incentive to BOX Options Participants
(``Participants'') to submit their customer orders for execution on
BOX, will aid BOX in recovering some of its costs incurred in providing
routing services to Participants, and will discourage potentially
abusive and predatory order routing practices to evade fees on other
exchanges.\5\ BOX will continue to provide routing to away exchanges at
no charge to Participants that execute more than 55% of their non-
Professional, Public Customer transactions \6\ on BOX, rather than
those orders being executed at other exchanges after BOX routes them to
an away exchange.
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    \5\ Note that BOX does not route broker-dealer proprietary
orders and thus does not assess them any routing fees. Based on BOX
market data, BOX believes certain Participants are intentionally
submitting orders to BOX when limited liquidity is on BOX at the
national best bid or offer (``NBBO''). This limited liquidity is not
enough to fill the orders submitted, and thus, BOX is required, in
accordance with its obligations to customer orders under the
national market system plan for Options Order Protection, to route
such orders to a market that is displaying liquidity at the NBBO.
    \6\ For the purposes of the discussion in this proposed rule
change, these non-Professional, Public Customer Orders will be
referred to as Public Customer Orders.
---------------------------------------------------------------------------

    BOX uses third-party broker-dealers to route orders to other
exchanges and incurs charges for each order routed to and executed at
an away market, in addition to the transaction fees charged by other
exchanges. BOX has been providing its routing services to Participants
for a limited amount of their Public Customer Orders at no cost and has
generally been able to cover such costs with revenue generated from
transactions on BOX. In order to better recover BOX's increasing costs
for routing such orders, the Exchange is proposing a modified routing
fee structure so that BOX can continue to provide routing services to
Participants at no charge if the Participants trade on BOX a greater
percentage of their Public Customer volume traded through BOX each
month, as opposed to BOX routing those orders away for execution.
    Currently, if 60% or more of a Participants' Public Customer Orders
executed through BOX each month are routed to and executed at an away
exchange, BOX assesses a $0.50 per contract routing fee to all of that
Participants' Public Customer orders routed to an away exchange for
execution for the month. If BOX does not have sufficient liquidity at
the NBBO to execute Public Customer Orders on BOX, such orders are
routed to an away exchange for execution. BOX, however, believes that
permitting Participants to continue routing a substantial percentage of
outbound Public Customer Orders without any fees is resulting in some
Participants intentionally sending orders to BOX when BOX is not at the
NBBO, so that the orders will be routed to an away exchange; and BOX
believes this activity pattern is designed to evade transaction fees on
other exchanges. In part to curtail this activity that BOX believes is
designed to take advantage of the BOX routing fee structure, the
Exchange proposes this modified routing fee structure that provides an
incentive to Participants whom execute a greater percentage of their
Public Customer transactions on BOX. The proposed change will have no
effect on the billing of orders of non-Participants, including any
orders routed to BOX from away exchanges.
    The Exchange proposes that BOX will continue to route Public
Customer Orders to an away exchange without imposing any fee, to the
extent that more than 55% of the Participants' Public Customer Orders
sent to BOX each month execute on BOX. Executions on BOX would include
orders executing on the BOX Book, or through any other BOX mechanism
that may be available to execute Public Customer Orders (e.g., Price
Improvement Period, Solicitation or Facilitation Auction Mechanisms).
If 45% or more of a Participants' Public Customer Orders executed
through BOX each month are routed to and executed at an away exchange,
BOX will assess a $0.50 per contract routing fee to all of a
Participants' Public Customer orders routed to an away exchange for
execution for the month. BOX will calculate the percentage of contracts
executed on BOX compared to the percentage routed and executed away at
the end of each month.
    Instructing BOX to route orders away if they are not able to be
executed on BOX is voluntary for BOX Participants. Participants may
choose not to route their Public Customer Orders to another exchange.
Participants may also avoid paying the proposed routing fee by choosing
to designate their orders as Fill and Kill (``FAK''). FAK orders are
not eligible for routing to away exchanges. FAK orders are executed on
BOX, if possible, and then cancelled. Imposing a routing fee structure
that provides a benefit to Participants for trading on BOX will allow
BOX to recoup a portion of the costs incurred for providing routing
services, while also providing an incentive to Participants to trade on
BOX and benefit from BOX routing services for a limited amount of their
Public Customer Orders at no charge.
    In contemplation of this proposed fee change, BOX considered the
costs incurred for providing routing services and the benefit provided
to Participants for whom orders are routed, as well as the revenue the
Exchange receives from transactions executed on BOX. The Exchange
believes the proposed change to BOX routing fees is fair, equitable,
and not unfairly discriminatory as BOX attempts to balance its costs
incurred for routing and the benefit for Participants that use the
service. Additionally, the Exchange has considered the Exchange costs
and the benefits to the BOX market and Participants' given their
ability to have their orders routed to an away exchange. Finally, the
Exchange proposes this fee change in part to attempt to balance the
costs and benefits considering the volumes of Public Customer
transactions routed to away exchanges and the volume of transactions
executed on BOX. While changes to the fee schedule pursuant to this
proposal will be effective upon filing, the changes will become
operative on August 1, 2012.
2. Statutory Basis
    The Exchange believes that the proposal is consistent with the
requirements of Section 6(b) of the Act,\7\ in general, and Section
6(b)(4) of the Act,\8\ in particular, in that it provides for the
equitable allocation of reasonable dues, fees, and other charges among
BOX Options Participants and other persons using its facilities. The
Exchange believes the changes proposed are an equitable allocation of
reasonable fees and charges among BOX Options Participants.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    BOX believes that the proposed routing fee structure for routing
non-Professional, Public Customer Orders to other market venues is
reasonable because the fee will allow BOX to recoup its transaction
costs attendant with offering routing services. BOX uses third-party
broker-dealers to route orders to other exchanges and incurs charges
for each order routed to and executed at an away market, in addition to
the transaction fees charged by other

exchanges. BOX has been providing its routing services to Participants
for a limited amount of their Public Customer Orders at no cost and has
been able to cover such costs with revenue generated from transactions
on BOX. In order to better recover BOX's increasing costs for routing
such orders, the Exchange is proposing a modified routing fee
structure. The Exchange believes this routing fee structure will allow
BOX to continue to provide routing services to Participants at no
charge if the Participants trade a greater percentage of their Public
Customer volume traded through BOX each month on BOX, as opposed to BOX
routing those orders away for execution.
    Additionally, BOX believes that assessing its routing fees to
Participants based on the percentage of Public Customer Orders traded
on BOX is an equitable allocation of a reasonable fee. Based on BOX
market data, BOX believes some Participants are intentionally
submitting orders to BOX when limited liquidity is on BOX at the NBBO.
This limited liquidity is not enough to fill the orders submitted, and
thus, BOX is required, in accordance with its obligations to customer
orders under the national market system plan for Options Order
Protection, route such orders to a market that is displaying liquidity
at the NBBO. BOX data indicates that BOX generally routes less than 45%
of a Participant's Public Customer Orders to BOX to an away exchange
for execution. Additionally, BOX believes that permitting a Participant
to have up to 45% of such orders routed to an away exchange for
execution without being assessed any routing fee is reasonable and
appropriate.
    The Exchange believes the proposed routing fee structure is
equitable and not unfairly discriminatory because the incentive to
trade on BOX is available to all Participants on an equal basis. The
Exchange believes it is reasonable and equitable to provide
Participants (A) an incentive to trade on BOX, and (B) the ability to
route a limited amount of customer orders at no cost, because
transactions executed on BOX increase BOX market activity and market
quality. Greater liquidity and additional volume executed on BOX aids
the price and volume discovery process. Participant trading on BOX also
results in revenue that BOX is able to use to provide routing services
for a limited amount of customer orders at no cost to Participants.
Accordingly, the Exchange believes that the proposal is not unfairly
discriminatory because it promotes enhancing BOX market quality. The
changes proposed by this filing are intended to provide an incentive to
BOX Participants to submit orders for execution on BOX, to aid BOX in
recovering its increasing routing costs, and to discourage Participants
from engaging in abusive and predatory practices to evade fees on other
exchanges.
    Further, BOX operates within a highly competitive market. BOX,
however, does not assess ongoing fees for access to BOX market data, or
fees related to order cancellation. As stated, BOX incurs costs,
including transaction fees at other exchanges, every time it routes a
customer order to an away exchange for execution. Providing routing
services draws on BOX system resources and routing more and more orders
results in greater ongoing operational costs to BOX. As such, BOX aims
to recover its increasing costs by assessing Participants fees for
routing Public Customer Orders to away exchanges, if those Participants
are submitting such orders to BOX so as to evade other exchanges' fees
and take advantage of BOX routing services. BOX therefore believes that
assessing the fee only to those Participants that have 45% or more of
their Public Customer Orders routed to an away exchange for execution
is reasonable, and an equitable allocation of its fees for providing
routing services.
    Finally, the Exchange notes that although routing is available to
BOX Participants for customer orders, Participants are not required to
use the routing services, but instead, BOX routing services are
entirely voluntary. As discussed above, BOX Participants can manage
their own routing to different options exchanges or can utilize a
myriad of other routing solutions that are available to market
participants.

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

    The Exchange does not believe the proposed rule change will impose
any burden on competition not necessary or appropriate in furtherance
of the purposes of the Act.

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Exchange Act \9\ and Rule 19b-4(f)(2)
thereunder,\10\ because it establishes or changes a due, fee, or other
charge applicable only to a member.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \10\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Exchange Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-BOX-2012-010 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-BOX-2012-010. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also

will be available for inspection and copying at the principal office of
the Exchange. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-BOX-
2012-010 and should be submitted on or before August 27, 2012.
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-19082 Filed 8-3-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 184 (Tuesday, September 22, 2020)]
[Notices]
[Pages 59600-59601]
[FR Doc No: 2020-20880]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[FAA-2020-0441]

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: NAS Data
Release Request

AGENCY: Federal Aviation Administration (FAA), Transportation (DOT).

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, the
FAA invites public comments about our intention to request the Office
of Management and Budget (OMB) approval to renew an information
collection. The collection is an application form, and collection
frequency is on occasion, depending on how often requests for National
Airspace System (NAS) data are submitted to the FAA. The information to
be collected will be used to evaluate the validity of a user's request
for NAS data from FAA systems and equipment.

DATES: Written comments should be submitted by November 23, 2020.

ADDRESSES: Please send written comments:
    By Electronic Docket: www.regulations.gov (Enter docket number into
search field).
    Because of the coronavirus pandemic, written comments are not being
received by mail or fax.

FOR FURTHER INFORMATION CONTACT: Michelle Somerday by email at:
<EMAIL_ADDRESS>phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for the FAA's performance; (b)
the accuracy of the estimated burden; (c) ways for the FAA to enhance
the quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.
    OMB Control Number: 2120-0668.
    Title: NAS Data Release Request.

    Form Numbers: FAA Form 1200-5.
    Type of Review: Renewal of an information collection.
    Background: This information collection is required to obtain or
retain a benefit, which is to obtain NAS data from the FAA. The
information submitted includes: Whether the requestor currently
receives NAS data, the authority to access NAS data, the type of data
requested, the proposed method for acquiring data, the purpose of the
request, the process for filtering sensitive data, and who at the
requestor's organization will be used for the data request, including
the scope and nature of work the individual will perform.
    This information must be collected to enable the FAA to evaluate
the validity of a user's request for NAS data from FAA systems and
equipment. The information provided by the requestor is used by the FAA
NAS Data Release Board (NDRB) to approve or disapprove individual
requests for NAS data, consistent with FAA Order 1200.22E External
Requests for National Airspace System (NAS) Data.
    Respondents: Approximately 15 requests submitted annually to the
FAA by requestors of NAS data.
    Frequency: On occasion.
    Estimated Average Burden per Response: 1 hour.
    Estimated Total Annual Burden: 15 hours total.

    Issued in Washington, DC, on July 15, 2020.
Virginia Boyle,
Deputy Vice President, System Operations Services.
[FR Doc. 2020-20880 Filed 9-21-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 150 (Tuesday, August 5, 2014)]
[Notices]
[Page 45439]
[FR Doc No: 2014-18486]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP13-485-000]

Texas Gas Transmission, LLC; Notice of Effectiveness of
Withdrawal of Application and Termination of Proceeding

    On June 3, 2014, Texas Gas Transmission, LLC filed a Notice of
Withdrawal to withdraw its application under section 7(b) of the
Natural Gas Act \1\ for authorization to abandon by sale to an
affiliate, Boardwalk Pipelines, LP, approximately 568 miles of 26-inch-
diameter pipeline on its mainline system from Eunice, Louisiana,
through Mississippi and Tennessee to Hardinsburg, Kentucky, as well as
associated pipeline facilities in Docket No. CP13-485-000.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 717f(c) (2012).
---------------------------------------------------------------------------

    No motion in opposition to the notice was filed with the Commission
within 15 days of the filing and the Commission did not disallow the
withdrawal within that period. Therefore, pursuant to 18 CFR 385.216(b)
(2014), the withdrawal became effective on June 18, 2014, 15 days from
the date of filing of the notice, and the proceeding was terminated.

    Dated: July 30, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-18486 Filed 8-4-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: October 5, 2006 (Volume 71, Number 193)]
[Notices]
[Page 58889-58890]
[DOCID:fr05oc06-88]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. IC-27507]

Notice of Applications for Deregistration Under Section 8(f) of
the Investment Company Act of 1940

September 29, 2006.
    The following is a notice of applications for deregistration under
section 8(f) of the Investment Company Act of 1940 for the month of
September, 2006. A copy of each application may be obtained for a fee
at the SEC's Public Reference Branch (tel.<PHONE_NUMBER>). An order
granting each application will be issued unless the SEC orders a
hearing. Interested persons may request a hearing on any application by
writing to the SEC's Secretary at the address below and serving the
relevant applicant with a copy of the request, personally or by mail.
Hearing requests should be received by the SEC by 5:30 p.m. on October
24, 2006, and should be accompanied by proof of service on the
applicant, in the form of an affidavit or, for lawyers, a certificate
of service. Hearing requests should state the nature of the writer's
interest, the reason for the request, and the issues contested. Persons
who wish to be notified of a hearing may request notification by
writing to the Secretary, U.S. Securities and Exchange Commission, 100
F Street, NE.,Washington, DC 20549-1090.
    For Further Information Contact: Diane L. Titus at<PHONE_NUMBER>,
SEC, Division of Investment Management, Office of Investment Company
Regulation, 100 F Street, NE., Washington, DC 20549-4041.

SEI Absolute Return Master Fund, L.P. [File No. 811-21350]

SEI Absolute Return Fund, L.P. [File No. 811-21351]

    Summary: Each applicant, a closed-end investment company, seeks an
order declaring that it has ceased to be an investment company.
Applicants have never made a public offering of their securities and do
not propose to make a public offering or engage in business of any
kind.
    Filing Dates: The applications were filed on July 20, 2006, and
amended on September 21, 2006 and September 27, 2006.
    Applicants' Address: One Freedom Valley Dr., Oaks, PA 19456.

Evergreen American Retirement Trust [File No. 811-5434]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On or about December 22, 1997, applicant
transferred its assets to Evergreen American Retirement Fund, a newly
created series of Evergreen Equity Trust, based on net asset value.
Expenses incurred in connection with the reorganization were paid by
applicant.
    Filing Date: The application was filed on September 21, 2006.
    Applicant's Address: 200 Berkeley St., Boston, MA 02116.

AmSouth Funds [File No. 811-5551]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On September 23, 2005, each of applicant's
series transferred its assets to one of the following corresponding
funds: Pioneer Value Fund, Pioneer Short Term Income Fund, Pioneer
Money Market Trust, Pioneer Fund, Pioneer Bond Fund, Pioneer Mid Cap
Value Fund, Pioneer Series Trust II, Pioneer Tax Free Income Fund,
Pioneer Series Trust I, Pioneer Series Trust IV and Pioneer Ibbotson
Asset Allocation Series, based on net asset value. Expenses of
$5,510,356 incurred in connection with the reorganization were paid by
AmSouth Asset Management Inc., applicant's investment adviser, Pioneer
Investment Management, Inc., the acquiring fund's investment adviser,
and AmSouth Bancorporation, the parent company of applicant's
investment adviser.
    Filing Dates: The application was filed on August 10, 2006, and
amended on September 21, 2006.
    Applicant's Address: 3435 Stelzer Rd., Columbus, OH 43219.

Mason Street Funds, Inc. [File No. 811-7961]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On March 24, 2006, a series of applicant,
Mason Street Index 400 Stock Fund, transferred its assets to a series
of Federated Index Trust, based on net asset value. On March 31, 2006,
applicant's remaining series transferred their assets, based on net
asset value, to corresponding series of the following funds: American
Century Mutual Funds, Inc., American Century Investment Trust, American
Century Capital Portfolios, Inc., American Century Quantitative Equity
Funds, Inc., American Century World Mutual Funds, Inc., American
Century Strategic Asset Allocations, Inc., American Century Municipal
Trust and Federated Index Trust. Expenses of $2,496,358 incurred in
connection with the reorganization were paid by Northwestern Mutual
Life Insurance Company, Mason Street Advisors, LLC, applicant's
investment adviser, American Century Companies, Inc., and Federated
Equity Management Company of Pennsylvania, or one or more of their
affiliates.
    Filing Date: The application was filed on August 29, 2006.
    Applicant's Address: 720 East Wisconsin Ave., Milwaukee, WI 53202.

UBS Aspen Fund, L.L.C. [File No. 811-9581]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. On June 30,
2006, applicant made a final liquidating distribution to its
shareholders, based on net asset value. Expenses of $59,316 incurred in
connection with the liquidation were paid by PFPC Inc., applicant's
administrator.
    Filing Date: The application was filed on August 24, 2006.
    Applicant's Address: c/o UBS Financial Services Inc., 1285 Avenue
of the Americas, New York, NY 10019.

Analysts Investment Trust [File No. 811-7778]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On November 30, 2005, applicant made a
liquidating distribution to its shareholders, based on net asset value.
Expenses of approximately $1,550 incurred in connection with the
liquidation were paid by Equity Analysts, Inc., applicant's investment
adviser.
    Filing Dates: The application was filed on August 14, 2006, and
amended on September 12, 2006.
    Applicant's Address: 7750 Montgomery Rd., Cincinnati, OH 45326.

AXP Stock Series, Inc. [File No. 811-498]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On March 7, 2006, applicant transferred its
assets to RiverSource Large Cap Series, Inc., based on net asset value.
Expenses of $59,494 incurred in connection with the reorganization were
paid by RiverSource Investments, LLC, applicant's investment adviser.
    Filing Dates: The application was filed on July 7, 2006, and
amended on September 8, 2006.
    Applicant's Address: 901 Marquette Ave. South, Suite 2810,
Minneapolis, MN 55402-3268.

Matterhorn Growth Fund, Inc. [File No. 811-3054]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On February 28, 2006, applicant transferred
its assets to CSI Equity Fund, a series of The World Funds, Inc., based
on net asset value. Expenses of $81,443 incurred in connection with the
reorganization were paid by applicant and the acquiring fund.
    Filing Dates: The application was filed on June 5, 2006, and
amended on August 1, 2006 and September 8, 2006.
    Applicant's Address: 301 Oxford Valley Rd., Suite 802B, Yardley, PA
19067.

The Treasurer's Fund, Inc. [File No. 811-5347]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On October 27, 2005, applicant made a
liquidating distribution to its shareholders, based on net asset value.
Expenses of $36,290 incurred in connection with the liquidation were
paid by Gabelli Fixed Income, LLC, applicant's investment adviser.
    Filing Dates: The application was filed on January 5, 2006, and
amended on September 25, 2006.
    Applicant's Address: c/o Gabelli Fixed Income, LLC, One Corporate
Center, Rye, NY 10580-1422.

DB Hedge Strategies Fund LLC [File No. 811-10561]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. Applicant is
not presently making a public offering of its securities and does not
propose to make a public offering. Applicant has one remaining
shareholder, which is an affiliate of the investment adviser, and will
continue to operate as a private investment fund in reliance on section
3(c)(1) of the Act.
    Filing Dates: The application was filed on March 9, 2006, and
amended on September 28, 2006.
    Applicant's Address: DB Investment Managers, Inc., 345 Park Ave.,
New York, NY 10154.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
Nancy M. Morris,
Secretary.
[FR Doc. E6-16461 Filed 10-4-06; 8:45 am]

BILLING CODE 8011-01-P


  MacroButton macIb01 i

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

<EPA Registration Division contact: [Roger Chesser,<PHONE_NUMBER>

Elizabeth Fertich,<PHONE_NUMBER>]>

<INSTRUCTIONS:  Please utilize this outline in preparing the pesticide
petition.  In cases where the outline element does not apply, please
insert “NA-Remove” and maintain the outline. Please do not change
the margins, font, or format in your pesticide petition. Simply replace
the instructions that appear in green, i.e., “[insert company
name],” with the information specific to your action.>

<TEMPLATE:>

<[Diversey, Inc.]>

<[Petition Number 1E7843]>

<	EPA has received a pesticide petition ([1E7843]) from [Diversey,
Inc.], [8310 16th Street, Sturtevant, WI, 53177] proposing, pursuant to
section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a(d), to amend 40 CFR part 180 to establish an exemption from
the requirement of a tolerance for the residues of FD&C Red No. 40
(conforming to 21 CFR 21 CFR §74.340) if used as an inert ingredient
(colorant) in no-rinse, food contact surface sanitizer (sanitizer)
products.  <EPA has determined that the petition contains data or
information regarding the elements set forth in section 408 (d)(2) of
FDDCA; 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.>>

FD&C Red No. 40 is an azo dye with the structural formula listed below.

The full chemical name of FD&C Red No. 40 is 2-NAPHTHALENESULFONIC ACID,
6-HYDROXY-5-[(2-METHOXY-5-METHYL-4-SULFOPHENYL)AZO]-, DISODIUM SALT, and
it has the CAS Registry Number 25956-17-6.  Commonly used synonyms are
Food Red No. 40 and FD&C Red No. 40 in the United States and Allura Red
AC in Europe.  The physical/chemical properties of the molecule have
been previously summarized (EPA, 2004).

<A. Residue Chemistry>

<	1. Plant metabolism.  >

<	2. Analytical method. [NA-Remove]>

<	3. Magnitude of residues. [Use of FD&C Red No. 40 in sanitizers will
not result in any residues on plants.  Residues of FD&C Red No. 40 are
exempt from the requirements of a tolerance when used as an inert
ingredient in pesticide formulations that are intended for application
on growing crops or on raw agricultural commodities after harvest (40
CFR 180.910).  The colorant cannot be used above 0.002% (20 ppm) by
weight in the formulation and must meet the certification requirements
specified in 21 CFR 74.340.  FD&C Red No. 40 is similarly approved for
use as a dye or coloring agent for seed treatment with a maximum
concentration of 2% by weight in the pesticide formulation (40 CFR
180.920).

The primary source of dietary exposure to FD&C Red No. 40 will most
likely occur from its existing use as a food and drug additive.   FDA
estimates that 95-97% of the certified color additives produced in the
United States are used domestically to manufacture food, drugs and
cosmetics (FDA, 2010).  An estimated 3%-5% of the domestic production is
exported.  Of these, approximately 73% is used in food, 10% in drugs and
3% in cosmetics.  Pesticidal uses were not mentioned but would fall
within the remaining 9-11% of use.  Accordingly, use of colorant in
sanitizers is expected to represent only a small percentage of the total
population exposure to the colorant.

Sanitizers are used in commercial eating establishments and food and
dairy processing facilities to sanitize food contact surfaces after
cleaning.  The products are applied after the surface has been
thoroughly cleaned.  The sanitizer is not rinsed off and is allowed to
air dry, resulting in a small amount of colorant residue on the food
contact surface.  Accumulation of FD&C Red No. 40 residues is not
expected since the surfaces are extensively cleaned between sanitizer
applications.

In the tolerance assessment for the use of FD&C Red No. 40 in
conventional pesticides, EPA noted that dyes are typically incorporated
into pesticide products at less than 0.1% (1000 ppm) based on
information in the PIRAT database (EPA, 2004). Most sanitizer products
are concentrates.  The product is diluted with water to produce the
use-solution, which is actually used to sanitize the surface. There are
some ready-to-use food contact surface sanitizing products available in
the consumer markets that do not require dilution, but these are
relatively rare.

Dilutions rates for sanitizer concentrates typically vary from 1:64
(1.54%) to 1:1028 (0.01%).  Assuming the maximum concentration of FD&C
Red No. 40 in the concentrated product is 0.1% based on the information
in the PIRAT database, the expected amount of FD&C Red No. 40 in the
use-solutions will range from 15 ppm (0.0015%) to 0.1 ppm (0.00001%).

 g FD&C Red No. 40 per cm2 of food contact surface.  The estimated
dietary exposures to FD&C Red No. 40 are discussed in section C.

EPA reviewed the environmental impact from use of FD&C Red No. 40 in
agricultural pesticides.  In agricultural use, the products are
discharged directly into the environment without treatment.  Based on
their review, EPA concluded that “modeling results indicate that
expected potential risks to aquatic organisms and soil and sediment
dwelling organisms resulting from the use of FD&C Blue No. 1, FD&C Red
No. 40, and FD&C Yellow No. 5 as inert ingredients in pesticide
formulations are low.” (EPA, 2004)

No-rinse food contact sanitizing solutions are typically indoor use
products.  These products are used at commercial facilities where there
is no direct discharge to the environment during recommended use.  The
used solutions are drained into the sanitary sewer of the facility,
where they are treated in accordance with permits issued under the Clean
Water Act.  After leaving the food processing facility, the
concentration of FD&C Red No. 40 in the waste-water will be reduced
further by dilution with other waste streams and by processing at the
waste water treatment facility.  Therefore, we would the ultimate
concentration of FD&C Red No. 40 discharged by a waste-water treatment
facility should be less than the concentration directly discharged to
the environment from agricultural uses.]>

<B. Toxicological Profile >

<	1. Acute toxicity.  [The European Food Safety Authority (EFSA) has
conducted the most recent (2009) full review of the toxicology of FD&C
Red No. 40.  This document relied heavily on the earlier reviews
conducted by the Joint FAO/WHO Expert Committee on Food Additives
(JECFA) which set the current, permanent Acceptable Daily Intake (ADI)
0-7 mg/kg-bw/day.(JECFA, 1981). For purposes of this petition, Diversey,
Inc. will summarize the key studies reported in these documents as the
basis for the toxicity discussion on FD&C Red No. 40.  The references
cited here correspond to the references in the EFSA, 2009 review.  No
compound related effects were observed when FD&C Red No. 40 (Allura Red
AC) was given to rats by gavage at doses varying from 215 to 10000
mg/kg.  Based on these studies, JECFA set the LD50 for rats at 10000
mg/kg-bw. Other studies in rabbits, dogs and mice produced LD50 values
of 10,000, 5000 and >2000 mg/kg, respectively.  Overall, the EFSA
concluded that “the acute oral toxicity of Allura Red AC  (FD&C Red
No. 40) is low.” ]>

<	2. Genotoxicity. [EFSA cited reviews by the European Scientific
Committee for Food (SCA), the JECFA and by TemaNord, to conclude that
FD&C Red No. 40 was determined to be non-mutagenic in a variety of in
vitro and in vivo based mutagenicity studies.  This determination is
consistent with EPA’s conclusion in the 2004 Tolerance Reassessment
for FD&C Red No. 40 (EPA, 2004).

In their 2009 review, EFSA cited a study from 2001 conducted on FD&C Red
No. 40 using the Comet assay.  The study showed an increase in migration
of nuclear DNA in the glandular stomach and the colon of male mice
exposed to doses of FD&C Red No. 40 of 100 mg/kg-bw and 10 mg/kg-bw
respectively.  Since histopathology of the effected organs appeared
negative, the study authors concluded that observed effect was not
likely to be related to cytotoxicity.  In light of the negative in vivo
carcinogenicity studies conducted on FD&C Red No. 40 (see below), EFSA
concluded that the significance of the Comet assay results was
uncertain.]>

	3. Reproductive and developmental toxicity. [Relevant reproductive and
developmental toxicity studies cited in the EFSA document are summarized
in Table 1.   Blackmore, 1969, observed slight growth suppression in F1
and F2 pups exposed to 5.19% of FD&C Red No. 40 in the diet during a
multi-generation type reproduction study in rats.  This dose was
calculated to be equivalent to 2595 mg/kg/day.  The fetal No Adverse
Effect Level (NOAEL) was 1.39% in the diet; equivalent to 695 mg/kg/day.
 The maternal NOEAL was 5.19% in the diet, which was equivalent to 2595
mg/kg/day. No other significant anomalies were detected in growth,
litter size, pup weight, gross pathology, implantation sites, resorption
sites, live fetuses indices, appearance, anatomy and structure were
observed.  The ADI of 7 mg/kg-bw/day for FD&C Red No. 40 was partially
based on this study.

Teratology studies in rats and rabbits showed no evidence of adverse
effects at 200 mg/kg-bw/day (gestation day (g.d.) 0-19) and 700
mg/kg/day (g.d. 6-18), respectively.

Reproductive toxicity endpoints were also monitored in three long-term
studies.

In a lifetime study in mice, the animals were fed up to 5.19% of FD&C
Red No. 40 in the diet.  Animals were also exposed throughout gestation
and lactation.  At the highest dose level, lower body weights and
effects on organ weight and organ/body weight ratios were noted but
considered to be “inconsequential.”  (Serota et al., 1977a).

In a nearly identical lifetime study with larger group numbers
(100/sex/group versus 50/sex/group in the original study), no compound
related adverse effects were observed.  The NOAEL’s in both studies
were determined to be 5.19% FD&C Red No. 40 in the diet, which was
calculated to be equivalent to 7300 and 8300 mg/kg-bw/day in male and
female mice, respectively.  (Reno et al., 1978)

Dietary administration of 5.19% FD&C Red No. 40 in rats was also studied
(Serota et al., 1977b).  Administration started throughout parental
breeding, gestation and lactation and continued for 118 and 121 weeks in
male and female rats, respectively.  For the female rats in the study,
mean body weights and growth rates were significantly lower in the high
dose group relative to controls.  No other significant adverse effects
were reported.  The NOAEL was 5.19% (2821 mg/kg-bw/day) in male rats and
1.3% (901 mg/kg-bw/day) in female rats.

A review conducted by TemaNord, 2002, discussed four additional
reproductive/developmental toxicity studies.

Rats (group number not reported) were exposed to up to 10% of FD&C Red
No. 40 in the diet (calculated doses of 0, 1250, 2500 and 5000
mg/kg-bw/day).  Litter mortality was increased between 22-24 days of age
at a concentration of 10% in the diet.  Significantly decreased running
wheel activity was observed in all exposed groups.  Increased open-field
rearing was observed in the two highest dose groups.  The Low Adverse
Effect Level (LOAEL) was determined to be 1250 mg/kg-bw/day; a NOAEL
could not be determined from this study (Voorhees, et al., 1983).

In a mouse study, animals (10/sex/group) were exposed to up to 1.68%
FD&C Red No. 40 in the diet over two generations (equivalent to 2400
mg/kg-bw/day). The study showed no significant, dose-related adverse
effects on reproduction or neurobehavioral endpoints following exposure
to FD&C Red No. 40 (Tanaka, 1994).

In rats (group number not reported) dosed with FD&C Red No. 40 up to
0.7% in drinking water (equivalent to 939 mg/kg-bw/day) on g.d. 0-20, a
significant increase in the incidence of fetuses with reduced
ossification of the hyoid was observed at the highest dose level.  No
other fetal malformations were observed.  The NOAEL from this study was
determined to be 546 mg/kg-bw/day (Collins et al., 1989a).

In rats dosed with FD&C Red No. 40 on g.d. 0-19 (group number not
reported), no significant, dose-related effects were observed at doses
up to 1000 mg/kg/day (Collins et al., 1989b).]

<	4. Subchronic toxicity. [FD&C Red No. 40 was studied in rats, dogs and
pigs in the following short-term studies.

In rats, groups of 20 animals (10 males and 10 females per group) were
fed diets containing 0-2595 mg/kg-bw/day) for six weeks.  The NOAEL was
determined to be at least 2595 mg/kg-bw/day.

Both of the dog studies were determined to be too limited to derive a
NOAEL.

The pig study appeared to be a non-standard design.  Groups of 4 animals
(2 males and 2 females per group) were dosed with 1000 mg/kg-bw/day of
FD&C Red No. 40 for 21 days.  The dose was increased to 1500
mg/kg-bw/day for an additional 54 days.  No compound related effects
were reported.

>

<	5. Chronic toxicity. [The chronic toxicity/carcinogenicity of FD&C Red
No. 40 was studied in 5 key studies.  These are summarized in Table 2.

In general, exposure to FD&C Red No. 40 did not result in significant
adverse effects.  In one mouse study, higher rates of early onset
lymphoma were observed in animals exposed to FD&C Red No. 40 (Serota et
al., 1977a).  However, this observation was not statistically
significant in this study and could not be replicated in a subsequent
study that used a higher number of animals per group (100 versus 50) and
an additional control group.  In general, the only significant effects
reported in these studies appeared to be growth suppression or body
weight reductions at high dietary doses used in these studies.]>

<	6. Animal metabolism. [The applicable studies were summarized in
JECFA, 1980.  In rats fed 5.19% FD&C Red No. 40 in the diet, only 0.1%
and 29% of the unmetabolized dye was found to be excreted in the urine
and feces, respectively.   Using 35S labeled FD&C Red No. 40, in dogs,
92-95% of the recovered radioactivity appeared in the feces and between
2.7 and 3.6% in the urine within 72 hours of administration.   In rats,
76-92% of the radioactivity was recovered in the feces and 5.7-19.8% in
the urine within the same timeframe.   Significant retention of the dye
was noted in the intestinal contents and in the washed intestines of
both species.  The total carcass and viscera of both species retained
only 0.4% of the total administered dose.

FD&C Red No. 40 is absorbed to a limited extent and that the major route
of the excretion is through metabolic by-products eliminated through the
feces.  Urinary excretion is negligible.]>

<	7. Metabolite toxicology. [Cresidine-4-sulfonic acid was identified as
the major metabolite in the urine and feces of both rats and dogs along
with the parent compound and two unknown metabolites.  In the dog, an
additional unknown metabolite was observed in the feces and possibly the
urine.  Metabolism in the GI tract may occur though the reduction of the
azo group in the parent compound.]>

<	8. Endocrine disruption. [In the 2004 tolerance reassessment, EPA did
not make a formal determination as to whether FD&C Red No. 40 impacts
the endocrine system pending the outcome of assays under the Endocrine
Disrupter Screening Program.  Overt effects on the endocrine system were
not reported in the toxicological studies conducted on the FD&C Red No.
40.

 M.  Aromatase catalyzes the conversion of androgens to estrogens and
presents a possible target for endocrine disrupting chemicals.  EFSA
concluded; however, that these data did not trigger a concern for FD&C
Red No. 40 since the chemical has limited systemic bioavailability and
that there was no evidence of related adverse effects in the various
reproduction studies conducted on the chemical.]>

<C. Aggregate Exposure>

<	1. Dietary exposure. [See below]>

<	i. Food. [Historically, FDA regulated sanitizer chemicals as indirect
food additives under the Federal Food, Drug and Cosmetic Act (codified
in 21 CFR §178.1010).  In 1993, FDA published guidance for assessing
dietary exposure to chemicals from sanitizing FDA described a tiered
assessment process for evaluating the safety of sanitizer solutions
based on where they are intended for use.  Solutions were approved for
use on food-contact surfaces in public eating places, dairy-processing
equipment and on food-processing equipment and utensils.

The model developed for public eating facilities was considered
sufficiently conservative to assure the safe use of sanitizers on food
processing equipment in dairy and other industries [40 CFR §180.940 (b)
and (c)].  FDA considered this a worst-case assessment and if a chemical
was approved for use in public eating facilities, it could also be used
at similar concentrations on dairy processing equipment and food
processing equipment and utensils.

Upon passage of the Food Quality Protection Act in 1996, EPA assumed
responsibility for the regulation of sanitizers.  The regulations
governing the use of sanitizers are currently codified under 40 CFR
§180.940 and follow the basic FDA outline from 21 CFR §178.1010.

180.940 (a)- regulates chemicals used as ingredients in antimicrobial
pesticide formulation that are applied to food-contact surfaces in
public eating places, dairy-processing equipment, and food processing
equipment and utensils.

180.940 (b)-regulates chemicals used as ingredients in antimicrobial
pesticide formulations that are applied to dairy-processing equipment
and food processing equipment and utensils.

180.940 (c)-regulates chemicals used as ingredients in antimicrobial
pesticide formulations that are applied to food processing equipment and
utensils.

The exposure model published by FDA in 1993 was adopted by EPA in
modified form for dietary risk assessments conducted on antimicrobials
as part of Reregistration. For purposes of this assessment, we relied on
the dietary exposure models used by EPA in their review of Alkyl
Dimethyl Benzyl Ammonium Chloride (ADBAC) under Reregistration (Shamim,
2006).

Public Eating Facilities

The EPA public eating facility model from the ADBAC Reregistration
Eligibility Decision (RED) is listed below.

EDI (mg/p/day) = AR x RS x SA x F x 10-6

DDD (mg/kg/day) = AR x RS x SA x F x 10-6/BW

EDI= Estimated Daily Intake

DDD= Daily Dietary Dose

AR = Application rate (ppm)

RS = Residual solution (mg/cm2) = 1 mg/cm 2

SA = Surface area of the treated surface which comes into contact with
food (cm2)= 4000 cm2

F = Fraction of the pesticide transferred or migrated to food (unitless)
= 1

BW = Body weight (kg)

Consistent with FDA’s 1993 guidance, the model assumes that all of the
food consumed by a single individual in a day contacts 4000 cm2 of food
contact surface area.  This figure represents a total surface area of
dishes, eating utensils and drinking glasses used by a person eating 3
meals a day in an institutional or other public eating facility.  The
worst-case amount of sanitizer residue (use-solution) is presumed to be
1 mg/cm2.

In the ADBAC RED, EPA slightly modified FDA’s original model to fit
their risk assessment requirements.  EPA converted the EDI to a “Daily
Dietary Dose” (DDD) by dividing the EDI by body weight.  The DDDs for
adult males (70kg), adult females (60 kg) and children (15 kg) were
determined.  EPA also incorporated a transfer factor (F), which is the
fraction of the chemical transferred or migrated to food. For ADBAC, the
Agency assumed that “F” equalled 10%.

Countertops

In the ADBAC RED, EPA also includes a model for countertop exposures
from the use of these products as disinfectants at a higher
concentration of active ingredient.  This model is identical to the one
developed for public eating facilities except that it assumes that food
will come into contact with 2000 cm2 of countertop area per day.
Diversey, Inc. incorporated this model into our assessment, assuming
that our products could be used to sanitize countertops that may
intentionally or inadvertently come into contact with food.

Dietary Exposure to FD&C Red No. 40 from Diversey, Inc. Products

Using EPA’s models as described in the ADBAC RED, we estimated the
dietary exposure to FD&C Red No. 40 from Diversey, Inc. sanitizer
products.  For purposes of this assessment, we assumed a concentration
of FD&C Red No. 40 of 20 ppm in the use-solution of the sanitizer
product.  For Diversey, Inc. products, the concentration of FD&C Red No.
40 in sanitizing use-solutions typically ranges from 0.1-0.4 ppm.  At
disinfecting concentrations (which require a potable water rinse), the
concentration range for FD&C Red No. 40 is from 0.2-3.1 ppm.

The use of 20 ppm is a worst-case scenario since it equals the maximum
amount present in the undiluted sanitizer product and is significantly
greater than the concentration of FD&C Red No. 40 in the actual
sanitizer use-solutions.

As our reference value, we relied on the ADI established by the
EFSA/FAO/WHO of 7 mg/kg-bw/day.  Since data were not available, we also
assumed that all of the FD&C Red No. 40 in the use-solution transferred
or migrated to food (F=1).]>

<	ii. Drinking water. [Sanitizer products are not intended to be added
to drinking water.  Therefore, direct exposure to FD&C Red No. 40 from
drinking water was not evaluated.  In the tolerance reassessment for
FD&C Red No. 40 published in 2004, EPA estimated that the amount of FD&C
Red No. 40 in the drinking water supply would be no greater than 1 ppb
from use of the colorant in conventional pesticides.  EPA concluded that
at this concentration in water, exposure to FD&C Red No. 40 would be
several orders of magnitude below current ADI’s.]>

<	2. Non-dietary exposure. [None expected.]>

<D. Cumulative Effects>

<	[When considering an exemption from the requirement of tolerance, the
Federal Food, Drug and Cosmetic Act requires consideration of the
cumulative effects of a particular pesticide residue under consideration
and in combination with other chemicals that share a common mechanism of
action.  EPA did not assume that FD&C Red No. 40 shared a common
mechanism of toxicity with any other substance in 2004, when the
tolerance for FD&C Red No. 40 in agricultural pesticides was reassessed.
 Currently, EPA has not made a common mechanism of toxicity finding for
FD&C Red No. 40 with any similar substances ( HYPERLINK
"http://www.epa.gov/pesticides/cumulative/"
http://www.epa.gov/pesticides/cumulative/ ).]>

<E. Safety Determination>

<	1. U.S. population. [Our analysis indicates that dietary exposure to
FD&C Red No. 40 at 20 ppm from use-solutions of sanitizers is only a
small fraction of the current ADI as established by FDA, the World
Health Organization and the European Food Safety Authority, for all
relevant age groups.   Our assessment is based on the FDA process,
modified by EPA, which has historically been used to assess dietary
exposure to sanitizer chemicals used in public eating establishments.
The public eating establishment model is considered the worst-case
assessment of dietary exposure to sanitizer chemicals.  Therefore, these
results are also applicable to sanitizers containing FD&C Red No. 40,
when used on dairy-processing equipment and food processing equipment
and utensils.]>

<	2. Infants and children. [In the 2004 tolerance reassessment for FD&C
Red No. 40, EPA concluded that there was “no concern for potential
sensitivity to infants and children resulting from exposures to… FD&C
Red No. 40.” (EPA, 2004)

In 2007, a paper was published studying the effect on children of
dietary exposure to FD&C Red No. 40 in combination with three other
artificial food colors and the preservative, sodium benzoate, on
children. (McCann et al., 2007).  The authors reported increased
hyperactivity in the 8/9 year old children exposed to the food
dye/sodium benzoate mixture.

In response, the Center for Science in the Public Interest (CSPI)
petitioned FDA in 2008 to ban eight of the nine approved food colorants
currently in use in the United States. The CPSI alleged that exposure to
food colorants causes hyperactivity and behavioral issues in some
children (CSPI, 2008).

FDA initiated a review of the issue in response to the CSPI petition,
which culminated in a meeting of the Food Advisory Committee in March,
2011.  FDA prepared a comprehensive review of the available literature
on the possible effects of food colorants on children (FDA, 2010).  The
McCann study was also reviewed in detail (Sobotka, et al., 2010).

Based on the information available, FDA concluded that a causal
relationship between exposure to color additives and hyperactivity in
children in the general population had not been established.  For
certain susceptible children with ADHD and other problem behaviors, the
FDA felt that the data suggested “these conditions may be exacerbated
by exposure to a number of substances in food, including, but not
limited to, artificial food colors.”  FDA also concluded that the
results of the cited studies indicate that the effects on behavior
appear to be due to “a unique intolerance to these substances and not
to any inherent neurotoxic properties.”   The Food Advisory committee
recommended that additional research be conducted on this subject.

FDA’s decision is summarized in the background document prepared for
the March, 2011 meeting (FDA, 2011). EFSA also reviewed the overall
science (EFSA, 2010) on this topic and also conducted a detailed review
of the McCann study (EFSA, 2008).  Their conclusions were similar to
FDA.  In their 2008 review of the McCann study, EFSA drew the following
conclusions.

The study provides limited evidence that the two different mixtures of
synthetic colors and sodium benzoate tested had a small and
statistically significant effect on activity and attention on some
children selected from the general population.

The effects were not observed for all children in all age groups and
were not consistent for the two mixtures.

The clinical significance of the effects was unclear and it is not known
whether the small alterations in attention and activity would interfere
with schoolwork or other intellectual functioning.

Since only mixtures were studied, it is not possible to ascribe any of
the observed effects to any one of components of the mixture.

The study was not sufficient to provide a basis to revise the existing
ADI (7 mg/kg-bw/day) based on the overall weight of evidence and the
relative weakness of the effects, and on the absence of information on
the clinical significance of the observed behavioral changes.

These conclusions were affirmed by EFSA in their overall reevaluation of
FD&C Red No. 40 as a food additive (EFSA, 2009).]>

<F. International Tolerances>

<	[United States Food and Drug Administration

FD&C Red No. 40 is permanently listed as a color additive for use in
food, drugs and cosmetics in the United States (21 CFR §74.340, Listing
of Color Additives Subject to Certification).  Certified versions of
this colorant are commercially available that meet FDA requirements as
specified under 21 CFR §70.25 (labelling), 21 CFR §80 (certification),
and 21 CFR §82.51 (specifications and labelling).

FDA does not specify an upper limit for the use of FD&C Red No. 40 in
food, only that it be used “generally in amounts consistent with good
manufacturing practices except that it may not be used to color foods
for which standards of identity have been promulgated under section 401
of the Act unless added color is authorized by such standards.”

Consistent with other reviewing authorities (see below), FDA has
determined an ADI for FD&C Red No. 40 of 7 mg/kg-bw/day (FDA, 2011).

European Union (EU)

In the European Union, FD&C Red No. 40 is listed as Allura Red AC (E
129) on Annex 1 of Directive 94/36/EC, List of Permitted Food Colours.
It is also approved for a number of specific food types under Annex III
of the Directive; “Foodstuffs to Which Only Certain Permitted Colours
may be Added.”(EU, 1994)

Codex Alimentarius

The Codex Alimentarius is a joint program of the United Nations Food and
Agricultural Organization and World Health Organization.  The primary
goals of the Code are “protecting health of the consumers and ensuring
fair trade practices in the food trade, and promoting coordination of
all food standards work undertaken by international governmental and
non-governmental organizations.”

The current approved food uses of FD&C Red No. 40 as listed in the code
are included in the attached reference (Codex, 2010).

European Food Safety Authority

EFSA. Scientific Opinion on the re-evaluation of Allura Red AC (E 129)
as a food additive.  EFSA Journal.  7(11): 1327.  Accessed 1-24-2011 at
HYPERLINK "http://www.efsa.europa.eu/en/efsajournal/pub/1327.htm"
http://www.efsa.europa.eu/en/efsajournal/pub/1327.htm  .

The EFSA, 2009 review on FD&C Red No. 40 is the most recent full
analysis of the safety of FD&C Red No. 40.  In their review, EFSA
reaffirmed the FAO/WHO acceptable daily intake of 0-7 mg/kg-bw/day.

2010- European Food Safety Authority (EFSA)- Scientific Opinion on the
appropriateness of the food azo-colours Tartrazine (E 102), Sunset
Yellow FCF (E 110), Carmoisine (E 122), Amaranth (E 123), Ponceau 4R (E
124), Allura Red AC (E129), Brilliant Black BN (E151), Brown FK (E 154),
Brown HT (E 155) and Litholrubine BK (E 180) for inclusion in the list
of food ingredients set up in Annex IIIa of Directive 2000/13/EC.
Accessed 2-4-2011 at  HYPERLINK
"http://www.efsa.europa.eu/en/efsajournal/pub/1778.htm"
http://www.efsa.europa.eu/en/efsajournal/pub/1778.htm .

Upon the request of the European Commission, the EFSA was asked to
provide a scientific opinion on the potential of food azo-colors to
cause intolerance and/or allergic reactions in humans following oral
exposure.  The Panel concluded that “it is unlikely that oral
consumption of the food colours under consideration, either individually
or in combination would trigger severe adverse reaction in human
subjects at current levels of use.”  Based on their review of the
literature, they found no data linking FD&C Red No. 40 to any
sensitivity or intolerance reactions while acknowledging that lack of
clinical awareness may result in an unknown degree of under-reporting.

European Scientific Committee for Food (SCF)

Scientific Committee for Food.  Reports of the Scientific Committee for
Food.  Fourteenth Series.  EUR 8752 EN.  1983.  pp. 52-53.   Accessed
1-24-2011 at  HYPERLINK
"http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_14.pdf"
http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_14.pdf  .

The SCF established an ADI of 0-7 mg/kg-bw/day based on the review
conducted by the Joint FAO/WHO Expert Committee on Food Additives at
their 25th meeting (see below).

Scientific Committee for Food.  Reports of the Scientific Committee for
Food. Twenty-First Series.  EUR 11617 EN.  1989.  p. 4.  Accessed
1-24-2011 at  HYPERLINK
"http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_21.pdf"
http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_21.pdf  .

The SCF maintained the ADI of 0-7 mg/kg-bw/day established in 1983.

Joint FAO/WHO Expert Committee on Food Additives (JECFA)

Joint FAO/WHO Expert Committee on Food Additives.  (WHO Food Additive
Series 6). Toxicological Evaluation of Some Food Colours, Enzymes,
Flavour Enhancers, Thickening Agents, and Certain Food Additives.  WHO
Food Additives Series 6.  1975.  Accessed 1-24-2011 at  HYPERLINK
"http://www.inchem.org/documents/jecfa/jecmono/v06je07.htm"
http://www.inchem.org/documents/jecfa/jecmono/v06je07.htm

In 1974, the JECFA conducted a review on FD&C No. 40 (Allura Red AC) but
was unable to determine an ADI because of gaps in the toxicology data
package.

Joint FAO/WHO Expert Committee on Food Additives (JECFA).  (WHO Food
Additive Series 15).  Allura Red AC.  Accessed 1-24-2011 at  HYPERLINK
"http://www.inchem.org/documents/jecfa/jeceval/jec_55.htm"
http://www.inchem.org/documents/jecfa/jeceval/jec_55.htm

 HYPERLINK "http://www.inchem.org/documents/jecfa/jecmono/v15je02.htm"
http://www.inchem.org/documents/jecfa/jecmono/v15je02.htm

Upon receipt of the data requested in their 1974 review, the JECFA
established a temporary ADI of 0-7 mg/kg-bw/day for FD&C Red No. 40
(Allura Red AC).

Joint FAO/WHO Expert Committee on Food Additives (JECFA). Evaluation of
certain food additives.  Twenty-Fifth Report of the Joint FAO/WHO Expert
Committee on Food Additives.  WHO Technical Report Series 669.  1981.
p. 18.   Accessed 1-24-2011 at  HYPERLINK
"http://whqlibdoc.who.int/trs/WHO_TRS_669.pdf"
http://whqlibdoc.who.int/trs/WHO_TRS_669.pdf  .

In this document, the JECFA made permanent the recommended ADI of 0-7
mg/kg-bw/day from WHO Food Additive Series 15.]>

 PAGE

 PAGE   13


Appendix C contains transportation conformity budget files for both ozone and PM2.5. The ozone files have been zipped together and are 42MB in size. The PM2.5 files have been zipped together and are 20MB in size. The files are available at the Region 2 office. Please contact Henry Feingersh at feingersh. henry@ epa. gov for these files.


http://www.arippa.org/coalrefuse.asp

Coal Refuse

Nanty Glo East waste pile

Photo courtesy of Pennsylvania Department of Environmental Protection

What is coal refuse?

Coal refuse is the low BTU-value waste material remaining from the coal
mining process that was simply discarded by mining companies for more
than 150 years - from the time mining first began in Pennsylvania in the
early 1800s through the late 1970s.

Coal refuse consists primarily of rock, with some attached carbon
material that was unable to be separated from the rock. This material
was heaped in refuse piles all through Pennsylvania's coal regions until
laws were enacted in the late 1970s that, for the first time, required
the coal companies to reclaim the sites that they mined. By the time
that these laws were enacted, upwards of 2.4 billion tons of coal refuse
had been discarded and abandoned in Pennsylvania.

No one is legally responsible to reclaim the coal refuse that was
discarded before the enactment of the state and federal laws in the
1970s.

Until the commercial development of the circulating fluidized bed
boiler, there was no use for this low BTU-value material. Now this
material can be put to good use in the production of clean energy.

Since the late 1980s, Pennsylvania's waste coal plants have removed over
100 million tons of polluting coal refuse from the environment and have
reclaimed over 3,800 acres of abandoned mine lands at no cost to
taxpayers.

What does a coal refuse pile look like?

The Nanty Glo East pile is located along Route 271 in Cambria County,
entering Nanty Glo from the South. The pile is one of three abandoned
refuse piles located along the South Branch of the Blacklick Creek in
Cambria County, Pennsylvania.

The other two piles, Revloc and Nanty Glo West, currently are being
reclaimed by Ebensburg Power Company, resulting in dramatic improvements
to the water quality of the South Branch of the Blacklick Creek, which
is a tributary to the Susquehanna River.

Ebensburg Power Company has plans to reclaim the Nanty Glo East pile,
which contains about 2.5 million tons of refuse over a 35 acre site and
was deposited between 1917 and 1945. When reclamation of Nanty Glo East
is completed, Ebensburg will have removed the three largest sources of
acid mine runoff into the South Branch.