[Federal Register: June 23, 2010 (Volume 75, Number 120)]
[Notices]
[Page 35781]
[DOCID:fr23jn10-63]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR10-33-000]

Kinder Morgan North Texas Pipeline LLC; Notice of Baseline Filing

June 16, 2010.
    Take notice that on June 14, 2010, Kinder Morgan North Texas
Pipeline LLC submitted a baseline filing of its Statement of Operating
Conditions for services provided pursuant to section 7(c) of the NGA
and Subpart G of Part 284 of the Commission's regulations.
    Any person desiring to participate in this rate proceeding must
file a motion to intervene or to protest this filing must file in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure (18 CFR 385.211 and 385.214). Protests will be considered
by the Commission in determining the appropriate action to be taken,
but will not serve to make protestants parties to the proceeding. Any
person wishing to become a party must file a notice of intervention or
motion to intervene, as appropriate. Such notices, motions, or protests
must be filed on or before 5 p.m. Eastern time on the date as indicated
below. Anyone filing an intervention or protest must serve a copy of
that document on the Applicant. Anyone filing an intervention or
protest on or before the intervention or protest date need not serve
motions to intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern time on Friday, June 25, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-15142 Filed 6-22-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)]
[Notices]
[Pages 3527-3529]
[FR Doc No: 2016-01054]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76902; File No. SR-Phlx-2016-01]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Delete
Phlx Rules 792, 794, 797, and 798

January 14, 2016.
    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 January 4, 2016, NASDAQ OMX PHLX LLC (``Phlx'' or ``Exchange'')
filed with the

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

    The Exchange proposes to delete Rules 792, 794, 797, and 798 from
the Phlx rules.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqomxphlx.cchwallstreet.com/, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of this proposed rule change is to delete Rules 792,
794, 797, and 798, which generally concern member organization
governance and ownership. As discussed below, the Exchange has
determined that these rules are anachronistic and no longer serve a
purpose. Consequently, the Exchange is proposing to eliminate the rules
from the rulebook to avoid any confusion that may be caused by
retaining them.
Rule 792
    Rule 792 concerns control of the voting stock of a member
organization. The rule requires the officers and directors of a member
organization that is a corporation to have working control of such
member organization. To comply with the rule, such officers and
directors must own at least fifty-five per cent (55%) of the voting
stock, and shall have contributed at least thirty per cent (30%) of the
total capital represented by all classes of stock. The rule allows the
Exchange to waive these requirements in specific cases, when it appears
that a majority of the officers and a majority of the directors are
actively engaged in the conduct of the business of such member
organization. As such, the rule is designed to ensure the management of
a member organization has more than a simple majority vote and a
significant investment in the firm.
    The Exchange believes that the rule is no longer relevant. The rule
was adopted at a time when the Exchange was owned by its members, and
member organizations (then known as ``member corporations'') were small
and privately held. Many of the Exchange's current member organizations
are large firms, which are publicly held and have a significant number
of issued shares. As a consequence, it is unreasonable to require the
management of the member organization to hold at least 55% of the
voting stock and to contribute at least 30% of the member
organization's total capital. Moreover, the Exchange notes that Phlx's
affiliate exchanges NASDAQ OMX BX (``BX'') and The Nasdaq Stock Market
(``Nasdaq'') do not have such restrictive ownership requirements.
Accordingly, the Exchange does not believe the rule serves a regulatory
purpose and it is accordingly proposing to delete the rule.
Rule 794
    Rule 794 concerns notice of the assignment of the voting stock of a
member organization. Specifically, the rule requires that no holder of
ten per cent (10%) or more of the common or voting stock in a member
organization that is a corporation may sell, assign, transfer, pledge,
or hypothecate their holdings of common or voting stock in such member
organization, except to such member organization or to officers or
directors thereof, without written notice to the Exchange. The rule
allows the Exchange to keep apprised of the significant holders of the
member organization's voting stock. Such holders would exercise
significant control of the member organizations.
    Similar to Rule 792 discussed above, the Exchange believes that the
rule is no longer relevant. The rule was adopted at a time when the
Exchange was owned by its members, and member organizations were small
and privately held. As noted, many of the Exchange's member
organizations now are large firms, which are publicly held and have a
significant number of issued shares. As a consequence, it is
unreasonable to require notice of the sale, assignment, transfer,
pledge, or hypothecation of 10% or more of the holdings of common or
voting stock of the member organization. Moreover, to the extent a
member organization is publicly held, the Exchange may readily access
the largest holders of member organization's stock. To the extent the
member organization is privately held, the Exchange may request a list
of shareholders from the member organization. The ownership of a member
organization is not a regulatory issue, but rather it was an issue to
the Exchange when the requirement was adopted because it was member-
owned. As such, influence of a member organization translated to
influence of the Exchange. The Exchange is now a wholly-owned
subsidiary of a publicly-traded company; therefore, member organization
influence as owners of the Exchange is no longer an issue.\3\ The
Exchange notes that neither BX nor Nasdaq have a similar requirement.
As a consequence, the Exchange does not believe the rule serves a
regulatory purpose and it is accordingly proposing to delete the rule.
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    \3\ The Exchange is wholly-owned by Nasdaq, Inc.
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Rule 797
    Rule 797 concerns loans to officers and directors of member
organizations. Specifically, the rule prohibits a member organization
from making any loan to any officer or director of the member
organization. The Exchange believes that the rule is outdated and a
remnant from when the Exchange was a member-owned organization. The
Exchange notes that neither BX nor Nasdaq has a similar prohibition.
Moreover, the Exchange notes that corporate law is generally a function
of state law, which in most cases allows loans to officers and
directors.\4\ Thus, the Exchange does not believe the rule serves a
regulatory purpose and it is accordingly proposing to delete the rule.
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    \4\ See, e.g., DEL. CODE ANN. tit. 8, Sec.  143 (2015).
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Rule 798
    Rule 798 discusses what is required of a corporation to be issued a
permit by the Exchange. A permit provides the right to a member to
trade on the Exchange and the right to vote for a Member Representative
Director. Permits are established by the Board of Directors. A
corporation may be issued a permit by the Exchange if the corporation
is incorporated under the laws of the Commonwealth of Pennsylvania, and
all of its shares are owned by the Exchange. The rule further provides
that such a corporate member whose shares are owned by the Exchange is
not liable for dues. This

rule was intended to permit Exchange membership for the Exchange's
subsidiary, the Stock Clearing Corporation of Philadelphia
(``SCCP'').\5\ The Exchange has since wound down SCCP and made it
inactive. Thus, the Exchange is deleting the rule.
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    \5\ See Securities Exchange Act Release No. 57134 (January 11,
2008), 73 FR 3306 (January 17, 2008) (SR-Phlx-2005-68) at note 6
(establishing the purpose of the requirement).
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\6\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\7\ 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, to
remove impediments to and perfect the mechanism of a free and open
market and a national market system and, in general, to protect
investors and the public interest. The Exchange believes the proposed
changes are consistent with just and equitable principles of trade
because they delete outdated and potentially confusing rules. Each of
the rules that the Exchange proposes to delete is anachronistic and
does not have application to the Exchange's current function as a for-
profit exchange whereby members no longer own the Exchange,\8\ but
rather are granted permits to trade thereon. Thus, the governance and
ownership requirements of Rules 792, 794 and 797, which generally
restrict member organizations from taking corporate actions that they
would otherwise be able to do, are no longer relevant. Eliminating Rule
798 is consistent with just and equitable principles of trade because
the Exchange no longer operates SCCP, which was the sole reason for the
rule's adoption. Thus, removing it from the rules promotes clarity and
eliminates potential confusion caused by allowing it to remain.
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    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
    \8\ See note 3 above.
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act. Rather it is designed to promote competition among exchanges
by removing archaic and overly restrictive rules in comparison to the
rules of other exchanges. Thus, the Exchange is able to compete without
the needless restrictions currently imposed by the deleted rules. Last,
the proposed changes promote clarity in the application of the
Exchange's rules by eliminating unneeded rules.

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

    No written comments were either solicited or received.

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

    Because the proposed rule change does not: (i) Significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate, the proposed rule change has become effective
pursuant to Section 19(b)(3)(A) of the Act \9\ and Rule 19b-4(f)(6)
thereunder.\10\
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    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission.
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2016-01 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Phlx-2016-01. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-Phlx-2016-01 and should be
submitted on or before February 11, 2016.
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    \11\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-01054 Filed 1-20-16; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: May 10, 2007 (Volume 72, Number 90)]
[Notices]
[Page 26625-26626]
[DOCID:fr10my07-72]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. RM05-17-000; RM05-25-000]

Preventing Undue Discrimination and Preference in Transmission
Service; Supplemental Notice of Technical Conferences

May 4, 2007.
    On April 6, 2007, the Commission issued a notice scheduling staff
technical conferences in the above-captioned proceeding. The Commission
hereby supplements that notice with additional information regarding
the technical conferences.
    As stated in the April 6 notice, these technical conferences will
review and discuss the ``strawman'' proposals regarding processes for
transmission planning required by the Final Rule issued in this
proceeding on February 16, 2007.\1\ Each transmission provider will be
responsible for presenting its ``strawman'' proposal on the day
identified in the attached schedule. To the extent transmission
providers have collaborated in the development of their ``strawman''
proposals, they may combine the presentation of those proposals.
Following the presentations in each subregion, opportunity will be
provided for comment and input from stakeholders and other interested
parties. All aspects of a transmission provider's ``strawman'' proposal
will be open for discussion.
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    \1\ Preventing Undue Discrimination and Preference in
Transmission Service, Order No. 890, 72 FR 12266 (March 15, 2007),
FERC Stats. & Regs. ] 31,241 at P 443 (2007), reh'g pending.
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    Commission staff is in the process of identifying panelists to
represent transmission providers and interested parties at each
technical conference. Please contact the staff identified below if you
are interested in participating as a panelist.\2\ Once panelists have
been identified, a further notice with a more detailed agenda for each
conference will be issued. In the event a transmission provider or
interested party is uncertain as to which technical conference is

relevant, such persons should contact staff in advance to discuss the
matter.
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    \2\ A/V equipment will be available for panelists wishing to use
PowerPoint or similar presentations.
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    For further information about these conferences, please contact:

W. Mason Emnett, Office of the General Counsel--Energy Markets, Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426,<PHONE_NUMBER><EMAIL_ADDRESS>Daniel Hedberg, Office of Energy Markets and Reliability, Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426,<PHONE_NUMBER><EMAIL_ADDRESS>
Kimberly D. Bose,
Secretary.
[FR Doc. E7-8973 Filed 5-9-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 97 (Thursday, May 19, 2016)]
[Rules and Regulations]
[Pages 31529-31531]
[FR Doc No: 2016-11729]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

49 CFR Part 175

[Docket No. PHMSA-2015-0165 (HM-262)]
RIN 2137-AF12

Hazardous Materials: Carriage of Battery-Powered Electronic
Smoking Devices in Passenger Baggage

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Final rule.

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SUMMARY: The Pipeline and Hazardous Materials Safety Administration
(PHMSA) is issuing a final rule to prohibit passengers and crewmembers
from carrying battery-powered portable electronic smoking devices
(e.g., e-cigarettes, e-cigs, e-cigars, e-pipes, e-hookahs, personal
vaporizers, electronic nicotine delivery systems) in checked baggage
and from charging these devices and their batteries on board the
aircraft. However, these devices may continue to be carried in carry-on
baggage. This action is consistent with the interim final rule (IFR)
published in the Federal Register on October 30, 2015, and a similar
amendment in the 2015-2016 Edition of the International Civil Aviation
Organization Technical Instructions for the Safe Transport of Dangerous
Goods by Air (ICAO Technical Instructions). This final rule amends the
Hazardous Materials Regulations to maintain alignment with the ICAO
Technical Instructions. Furthermore, this final rule does not impact
the existing rules on the transport of lithium batteries or other
portable electronic devices that are transported for personal use in a
passenger's checked or carry-on baggage.

DATES: Effective: June 20, 2016.

FOR FURTHER INFORMATION CONTACT: Kevin A. Leary,<PHONE_NUMBER>,
Standards and Rulemaking Division, Pipeline and Hazardous Materials
Safety Administration, U.S. Department of Transportation, 1200 New
Jersey Ave. SE., Washington, DC 20590-0001.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
II. Comment Discussion
III. Regulatory Analyses and Notices
    A. Statutory Authority for This Rulemaking
    B. Executive Order 12866, Executive Order 13563, and DOT
Regulatory Policies and Procedures
    C. Executive Order 13132
    D. Executive Order 13175
    E. Regulatory Flexibility Act, Executive Order 13272, and DOT
Procedures and Policies
    F. Paperwork Reduction Act
    G. Regulation Identifier Number (RIN)
    H. Unfunded Mandates Reform Act
    I. Executive Order 13609 and International Trade Analysis
    J. Environmental Assessment
    K. Privacy Act
IV. List of Subjects

I. Background

    On October 30, 2015, PHMSA published an IFR in the Federal Register
[80 FR 66817] that prohibits passengers and crewmembers from carrying
battery-powered portable electronic smoking devices (e.g., e-
cigarettes, e-cigs, e-cigars, e-pipes, personal vaporizers, electronic
nicotine delivery systems) in checked baggage and from charging these
devices and their batteries on board the aircraft. The use of battery-
powered portable electronic smoking devices has been rising
substantially, and they have increasingly become a common item in
passenger baggage. Prior to the issuance of this IFR, airline
passengers and crewmembers were permitted to carry these devices in
either checked or carry-on baggage under the provisions for portable
electronic devices contained in Sec.  175.10(a)(18) of the Hazardous
Materials Regulations (HMR; 49 CFR parts 171-180). However, the
provisions for portable electronic devices do not adequately address
the safety risks posed by battery-powered portable electronic smoking
devices, which include a heating element as a function of their design.
Specifically, a battery-powered portable electronic smoking device
contains a liquid, an atomizer or heating element, and a battery. When
this device is operated the heating element vaporizes the liquid, so
when in checked baggage, the device may lead to the generation of
extreme heat with potential ignition of nearby contents.
    Recent fire incidents involving battery-powered portable electronic
smoking devices in checked baggage and actions taken by the Federal
Aviation Administration (FAA) and ICAO all of which are described in
the October 30, 2015 IFR, prompted action to address this issue. The
requirements in this final rule apply only to battery-powered portable
electronic smoking devices (e.g., e-cigarettes, e-cigs, e-cigars, e-
pipes, e-hookahs, personal vaporizers, electronic nicotine delivery
systems). Notably, this final rule does neither prohibits passengers
from transporting other devices containing batteries for personal use
(such as laptop computers, cell phones, cameras, etc.) in checked or
carry-on baggage, nor does it restrict passengers from transporting
batteries for personal use in carry-on baggage.

II. Comment Discussion

    PHMSA received eleven comments to the October 30, 2015 IFR: Four of
the commenters supported the provisions of the IFR as written; four of
the commenters suggested the prohibition of the carriage of battery-
powered portable electronic smoking devices should be extended to
carry-on baggage; one commenter suggested that the prohibition should
also be extended to prohibit such devices to be transported as mail on
passenger aircraft; and two commenters objected to all or part of the
IFR.
    The four commenters who recommended that PHMSA extend the
prohibition of the IFR to prohibit the carriage of battery-powered
portable electronic smoking devices in carry-on and checked baggage
noted that if these devices pose a fire risk they should not be
permitted in the cabin of an aircraft either. PHMSA believes that
prohibiting the carriage of these devices only in checked baggage best
targets the safety issue that we are addressing. Permitting the
carriage of these devices only in carry-on baggage or on the person
would be the best alternative because when carried in the passenger
cabin, the flight crew can quickly intervene in the case of
overheating, short circuit, or fire.
    One commenter recommended that PHMSA amend the IFR to prohibit the
transport of battery-powered portable electronic smoking devices in the
mail because a package containing such devices could be carried as mail
aboard a passenger aircraft. The HMR do not apply to any matter subject
to the postal laws and regulations of the United States; therefore,
this amendment is beyond the scope of PHMSA's regulatory authority (see
Sec.  171.1(d)(7)). However, we shared the comment with the United
States Postal Service (USPS) for their consideration.
    Of the two commenters who objected to all or part of the IFR, one
was

opposed to the provisions and suggested that the devices should be made
safer rather than restricting their use. PHMSA is taking this action to
address a documented safety issue, and we do not believe the
restrictions will place an undue burden on device manufacturers,
aircraft passengers, crewmembers, or airlines. The other commenter
recommended that PHMSA amend the IFR to eliminate the prohibition
against the charging of standalone e-cigarette batteries, further
providing information on one specific product that incorporates safety
circuitry to prevent overcharge and evidence that it is intended to be
charged only when removed from the heater cartridge. In the IFR, PHMSA
noted that many of the documented device failures occurred while the
device was charging, resulting in the ignition of nearby combustible
materials. PHMSA restricted charging of the devices and their batteries
during flight to address those concerns and to maintain consistency
with the ICAO Technical Instructions. While the commenter provided
information on one battery-powered portable electronic smoking device,
there are many configurations, both with and without removable
batteries, to consider. Additionally, users who modify their device may
bypass the built-in safety circuitry designed to prevent overheating.
PHMSA determined that the limited prohibition against the carriage of
battery-powered portable electronic smoking devices in checked baggage
and a prohibition against the charging of these devices and their
batteries while on board the aircraft address the known risks in the
narrowest possible way.

III. Regulatory Analyses and Notices

A. Statutory Authority for This Rulemaking

    This rulemaking is issued under the authority of the Federal
Hazardous Materials Transportation Law (49 U.S.C. 5101 et seq.), which:
(1) Authorizes the Secretary of Transportation to prescribe regulations
for the safe transportation, including security, of hazardous materials
in intrastate, interstate, and foreign commerce (49 U.S.C. 5103(b));
(2) authorizes the Administrator of the Federal Aviation Administration
to promote safe flight of civil aircraft in air commerce by prescribing
regulations and minimum standards for practices, methods, and
procedures the Administrator finds necessary for safety in air commerce
and national security (49 U.S.C. 44701); and (3) authorizes the
Secretary of Transportation to ensure that, to the extent practicable,
regulations governing the transportation of hazardous materials in
commerce are consistent with standards adopted by international
authorities (49 U.S.C. 5120(b)).
    In this final rule, PHMSA amends the HMR to maintain alignment with
the ICAO Technical Instructions.

B. Executive Order 12866, Executive Order 13563, and DOT Regulatory
Policies and Procedures

    Executive Orders 12866 (``Regulatory Planning and Review'') and
13563 (``Improving Regulation and Regulatory Review'') require Federal
agencies to regulate in the ``most cost-effective manner,'' to make a
``reasoned determination that the benefits of the intended regulation
justify its costs,'' and to develop regulations that ``impose the least
burden on society.'' This final rule is not considered a significant
regulatory action under Executive Order 12866 and the Regulatory
Policies and Procedures of the Department of Transportation [44 FR
11034].
    PHMSA does not anticipate that the actions in this final rule will
impose a significant impact on airlines, airline passengers,
crewmembers, or the Federal government. In fact, most U.S. airlines
proactively notified airline passengers (e.g., Web sites, automated
check-in facilities, signage, and verbal notifications from the
operator) prior to the issuance of the October 30, 2015 IFR. PHMSA, the
FAA, and the Transportation Security Administration (TSA) each updated
its guidance to passengers on prohibited items, including battery-
powered portable electronic smoking devices, to reflect the provisions
of the IFR. Moreover, airline passengers and crewmembers are still
permitted to carry battery-powered portable electronic smoking devices
in their carry-on baggage or on their person. Spare lithium batteries
must be individually protected by placement in original retail
packaging or by otherwise insulating terminals (e.g., by taping over
exposed terminals or placing each battery in a separate plastic bag or
protective pouch). However, as this is consistent with existing
requirements for the carriage of spare lithium batteries for portable
electronic devices, PHMSA does not anticipate this will have any impact
on passengers. Some passengers may incur a non-quantifiable cost in the
lost opportunity to charge their device while on board the aircraft,
but PHMSA expects this will be a small number of passengers and the
per-passenger cost will be small.

C. Executive Order 13132

    This final rule has been analyzed in accordance with the principles
and criteria contained in Executive Order 13132 (``Federalism''),
published in the Federal Register on August 10, 1999 [64 FR 43255], and
the President's memorandum (``Preemption''), published in the Federal
Register on May 22, 2009 [74 FR 24693]. This final rule does not adopt
any regulation that: (1) Has substantial direct effects on the states,
the relationship between the national government and the states, or the
distribution of power and responsibilities among the various levels of
government; or (2) imposes substantial direct compliance costs on State
and local governments. PHMSA is not aware of any State, local, or
tribal requirements that would be preempted by amending the provisions
for the carriage of battery-powered portable electronic smoking devices
by airline passengers or crewmembers. In addition, this final rule does
not have sufficient federalism impacts to warrant the preparation of a
federalism assessment.

D. Executive Order 13175

    This final rule has been analyzed in accordance with the principles
and criteria contained in Executive Order 13175 (``Consultation and
Coordination with Indian Tribal Governments''). This final rule does
not have tribal implications and does not impose substantial direct
compliance costs, therefore the funding and consultation requirements
of Executive Order 13175 do not apply.

E. Regulatory Flexibility Act, Executive Order 13272, and DOT
Procedures and Policies

    The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) requires
Federal agencies to review regulations to assess their impact on small
entities, unless the agency determines that a rule is not expected to
have a significant impact on a substantial number of small entities.
Although this final rule places a limited prohibition on the carriage
of battery-powered portable electronic smoking devices by airline
passengers and crewmembers in checked baggage, such individuals would
still be permitted to carry these devices in carry-on baggage or on
their person. The provisions of this final rule do not impose any
direct or indirect adverse economic impacts for small units of
government, businesses, or other organizations, and PHMSA did not
receive any comments specifically relating to the impact of the IFR
rule on small entities.

F. Paperwork Reduction Act

    There are no new information collection requirements in this final
rule.

G. Regulation Identifier Number (RIN)

    A regulation identifier number (RIN) is assigned to each regulatory
action listed in the Unified Agenda of Federal Regulations. The
Regulatory Information Service Center publishes the Unified Agenda in
April and October of each year. The RIN contained in the heading of
this document can be used to cross-reference this action with the
Unified Agenda.

H. Unfunded Mandates Reform Act

    This rule does not impose unfunded mandates under the Unfunded
Mandates Reform Act of 1995. It does not result in costs of $155
million or more, adjusted for inflation, to State, local, or tribal
governments, in the aggregate, or to the private sector in any one
year, and it is the least burdensome alternative that achieves the
objective of the rule.

I. Executive Order 13609 and International Trade Analysis

    Under Executive Order 13609 (``Promoting International Regulatory
Cooperation''), Federal agencies must consider whether the impacts
associated with significant variations between domestic and
international regulatory approaches are unnecessary or may impair the
ability of American business to export and compete internationally. In
meeting shared challenges involving health, safety, labor, security,
environmental, and other issues, international regulatory cooperation
can identify approaches that are at least as protective as those that
are or would be adopted in the absence of such cooperation.
International regulatory cooperation can also reduce, eliminate, or
prevent unnecessary differences in regulatory requirements.
    Similarly, the Trade Agreements Act of 1979 (Pub. L. 96-39), as
amended by the Uruguay Round Agreements Act (Pub. L. 103-465),
prohibits Federal agencies from establishing any standards or engaging
in related activities that create unnecessary obstacles to the foreign
commerce of the United States. For purposes of these requirements,
Federal agencies may participate in the establishment of international
standards, so long as the standards have a legitimate domestic
objective, such as providing for safety, and do not operate to exclude
imports that meet this objective. The statute also requires
consideration of international standards and, where appropriate, that
they be the basis for U.S. standards.
    PHMSA participates in the establishment of international standards
in order to protect the safety of the American public, and we have
assessed the effects of this final rule to ensure that it does not
cause unnecessary obstacles to foreign trade. Therefore, this
rulemaking is consistent with Executive Order 13609 and PHMSA's
obligations under the Trade Agreement Act, as amended.

J. Environmental Assessment

    The National Environmental Policy Act of 1969 (NEPA), as amended
(42 U.S.C. 4321-4347), requires that Federal agencies consider the
consequences of major Federal actions and prepare a detailed statement
on actions significantly affecting the quality of the human
environment. This final rule only impacts how a passenger may carry
battery-powered portable electronic smoking devices on aircraft, not
whether a passenger may carry such devices. We find that there are no
significant environmental impacts associated with this final rule.

K. Privacy Act

    Anyone may search the electronic form of written communications and
comments received into any of our dockets by the name of the individual
submitting the document (or signing the document, if submitted on
behalf of an association, business, labor union, etc.). The DOT's
complete Privacy Act Statement can be found in the Federal Register
published on April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or
by visiting http://www.regulations.gov/search/footer/privacyanduse.jsp.

List of Subjects in 49 CFR Part 175

    Air carriers, Hazardous materials transportation, Radioactive
materials, Reporting and recordkeeping requirements.

    In consideration of the foregoing, we amend 49 CFR Chapter I as
follows:

PART 175--CARRIAGE BY AIRCRAFT

0
1. The authority citation for part 175 continues to read as follows:

    Authority: 49 U.S.C. 5101-5128, 44701; 49 CFR 1.81 and 1.97.

0
2. In Sec.  175.10, revise paragraph (a)(19) to read as follows:

Sec.  175.10  Exceptions for passengers, crewmembers, and air
operators.

    (a) * * *
    (19) Except as provided in Sec.  173.21 of this subchapter,
battery-powered portable electronic smoking devices (e.g., e-
cigarettes, e-cigs, e-cigars, e-pipes, e-hookahs, personal vaporizers,
electronic nicotine delivery systems) when carried by passengers or
crewmembers for personal use must be carried on one's person or in
carry-on baggage only. Spare lithium batteries also must be carried on
one's person or in carry-on baggage only and must be individually
protected so as to prevent short circuits (by placement in original
retail packaging or by otherwise insulating terminals, e.g., by taping
over exposed terminals or placing each battery in a separate plastic
bag or protective pouch). Each lithium battery must be of a type which
meets the requirements of each test in the UN Manual of Tests and
Criteria, Part III, Subsection 38.3. Recharging of the devices and/or
the batteries on board the aircraft is not permitted. Each battery must
not exceed the following:
    (i) For lithium metal batteries, a lithium content of 2 grams; or
    (ii) For lithium ion batteries, a Watt-hour rating of 100 Wh.
* * * * *

    Issued in Washington, DC, on May 13, 2016, under authority
delegated in 49 CFR 1.97.
Marie Therese Dominguez,
Administrator, Pipeline and Hazardous Materials Safety Administration.
[FR Doc. 2016-11729 Filed 5-18-16; 8:45 am]
BILLING CODE 4910-60-P


                           APPENDIX I - PRODUCT LIST

EPA Registration Number: 			Product Name

47000-19						Dy-Fly 1 Livestock Spray
47000-101						CT-42


[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Notices]
[Pages 57448-57450]
[FR Doc No: 2019-23272]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA 2013-N-0719]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Planning for the Effects of High Absenteeism To Ensure
Availability of Medically Necessary Drug Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection for the guidance
on planning for the effects of high absenteeism to ensure availability
of medically necessary drug products.

DATES: Submit either electronic or written comments on the collection
of information by December 24, 2019.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before December 24, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 24, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-N-0719 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Planning for the Effects of High
Absenteeism to Ensure Availability of Medically Necessary Drug
Products.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://

www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Planning for the Effects of High Absenteeism To Ensure Availability of
Medically Necessary Drug Products

OMB Control Number 0910-0675--Extension

    This information collection supports recommendations found in
Agency guidance. Specifically, we have developed guidance intended to
encourage manufacturers of drug and therapeutic biological products,
and any raw materials and components used in those products, to develop
a written Emergency Plan (Plan) for maintaining an adequate supply of
medically necessary drug products (MNPs) during an emergency that
results in high employee absenteeism. The guidance document entitled,
``Planning for the Effects of High Absenteeism to Ensure Availability
of Medically Necessary Drug Products,'' discusses the elements that
should be covered by such a Plan, and is available from our website at:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/planning-effects-high-absenteeism-ensure-availability-medically-necessary-drug-products.
    We estimate the burden of this collection of information as
follows:

                                                      Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                               Number of
                      Activity                             Number of         responses per       Total annual       Average  burden       Total hours
                                                          respondents         respondent           responses         per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Activate/deactivate Plan as recommended in the                        2                   1                   2                  16                  32
 guidance...........................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                    Table 2--Estimated Annual Recordkeeping Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           Number of      Number of  records     Total annual       Average  burden
                      Activity                           recordkeepers     per  recordkeeper        records        per  recordkeeper      Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Develop initial Plan as recommended in the guidance.                 70                   1                  70                 250              17,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    As explained in the guidance, we provide recommendations for
developing and implementing a written Plan, including: (1) Identifying
a person or position title (as well as two designated alternates) with
the authority to activate and deactivate the Plan and make decisions
during the emergency; (2) prioritizing the manufacturer's drug products
based on medical necessity; (3) identifying actions that should be
taken prior to an anticipated period of high absenteeism; (4)
identifying criteria for activating the Plan; (5) performing quality
risk assessments to determine which manufacturing activities may be
reduced to enable the company to meet a demand for MNPs; (6) returning
to normal operations and conducting a post-execution assessment of the
execution outcomes; and (7) testing the Plan.
    The guidance also encourages manufacturers to include and document
procedures in the Plan for notifying the FDA Center for Drug Evaluation
and Research (CDER) when the Plan is activated and when returning to
normal operations. The guidance recommends that these notifications
occur within 1 day of a Plan's activation and within 1 day of a Plan's
deactivation. The guidance identifies the information that should be
included in these notifications, such as which drug products will be
manufactured under altered procedures, which products' manufacturing
will be temporarily delayed, and any anticipated or potential drug
shortages. We assume two notifications (for purposes of this analysis,
we consider an activation and a deactivation notification to equal one
notification) will be submitted to CDER

annually, and assume each notification requires 16 hours to prepare and
submit.
    Finally, the guidance recommends developing a Plan for each
individual manufacturing facility as well as a broader Plan that
addresses multiple sites within the organization. For purposes of this
information collection analysis, we consider the Plan for an individual
manufacturing facility and the broader Plan to comprise one Plan for
each manufacturer. Based on available data on the number of
manufacturers that would be covered by the guidance, we previously
estimated 70 manufacturers will develop a Plan as recommended by the
guidance (i.e., one Plan per manufacturer, to include all manufacturing
facilities, sites, and drug products) and that each Plan would take
approximately 500 hours to develop. Upon development of the plan,
however, we believe fewer hours are necessary to maintain and update it
as needed. As FDA issued the guidance in 2011, we now assume that most
respondents have developed the recommended plan, and therefore we limit
our current burden estimate to updates and maintenance. Accordingly, we
have reduced our estimate by half, reasoning that, although it takes
fewer hours for updates and maintenance, new respondents may choose to
adopt recommendations found in the guidance.

    Dated: October 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23272 Filed 10-24-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: September 26, 2007 (Volume 72, Number 186)]
[Notices]
[Page 54656-54658]
[DOCID:fr26se07-64]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0935; FRL-8149-1]

N-methyl Carbamate Revised Cumulative Risk Assessment; Notice of
Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces the availability of EPA's revised
cumulative risk assessment for the N-methyl carbamate group of
pesticides, and opens a public comment period on this document and
other support documents. As required by the Food Quality Protection Act
(FQPA), a cumulative risk assessment, which evaluates exposures based
on a common mechanism of toxicity, was conducted to evaluate the risk
from food, drinking water, residential, and other non-occupational
exposures resulting from registered uses of N-methyl carbamate
pesticides. The N-methyl carbamate group includes aldicarb, carbaryl,
carbofuran, formetanate HCl, methiocarb, methomyl, oxamyl, pirimicarb,
propoxur, and thiodicarb.

DATES: Comments must be received on or before November 26, 2007.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-0935, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2007-0935. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information

claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Do not submit
information that you consider to be CBI or otherwise protected through
regulations.gov or e-mail. The regulations.gov website is an
``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the docket and made available on the Internet. If you submit
an electronic comment, EPA recommends that you include your name and
other contact information in the body of your comment and with any disk
or CD-ROM you submit. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.
    Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket

Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov
website to view the docket index or access available documents.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the OPP

Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The hours of operation of this
Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Neil Anderson, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1.  Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
     ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background

A. What Action is the Agency Taking?

    EPA is making available the completed cumulative risk assessment
for the N-methyl carbamate pesticides. The Agency developed this risk
assessment as part of its ongoing process for making pesticide
reregistration eligibility and tolerance reassessment decisions.
Through these programs, EPA is ensuring that pesticides meet current
standards under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) and the Federal Food, Drug and Cosmetic Act (FFDCA), as amended
by the FQPA.
    Section 408(b)(2)(D)(v) of the FFDCA directs the Agency to consider
available information on the cumulative risk from substances sharing a
common mechanism of toxicity. The Agency determined in 2004 that the N-
methyl carbamate pesticides share a common mechanism of toxicity,
cholinesterase inhibition. The N-methyl carbamates have been among
EPA's highest priority pesticides for review under FQPA.
    In developing the N-methyl carbamate cumulative risk assessment,
EPA employed the methodologies utilized in earlier cumulative risk
assessments (i.e., the organophosphate pesticides) and consulted with
the FIFRA Scientific Advisory Panel numerous times, seeking expert
review, advice, and recommendations at each major step of the process.
The Agency also met with several of its advisory committees to obtain
input from a broad spectrum of stakeholders representing the pesticide
industry, environmental and public interest groups, growers, academia,
and others, including other federal and state regulatory agencies. EPA
issued the Estimation of Cumulative Risk from N-methyl Carbamate
Pesticides: Preliminary Assessment in August 2005. The N-methyl
Carbamate Revised Cumulative Risk Assessment is considered an addendum
to the August 2005 assessment, and includes improvements and
refinements in assessing the cumulative risks of the N-methyl carbamate
pesticides. The previous versions of the N-methyl carbamate cumulative
risk assessment may be accessed on the EPA website at

http://www.epa.gov/pesticides/cumulative.

    EPA has concluded that, with the adoption of the risk mitigation
measures evaluated in the N-methyl carbamate cumulative risk
assessment, all of the N-methyl carbamate pesticide tolerances assessed
in this risk assessment meet the safety standard set forth in section
408(b)(2)(a) of the FFDCA. For those tolerances, this conclusion
terminates the tolerance reassessment process under section 408(q) of
the FFDCA. For all of the chemicals, to the extent that the safety
determination for these uses based on the cumulative risk assessment
was the only remaining issue to complete the reregistration eligibility
determination for a particular chemical under section 4(g)(2)(A) of
FIFRA, the Agency now considers that determination (consistent with the
risk mitigation measures described in the cumulative assessment) to be
complete. As noted in the Introduction to the cumulative risk
assessment, certain tolerances and uses were omitted from the risk
assessment because EPA had previously determined that these uses or
tolerances did not meet the safety standards based on their individual,
aggregate risks or should be canceled for other reasons. These
tolerances and uses are identified in Appendix II.A of the cumulative
risk assessment. The cumulative assessment does not change the Agency's
determination with respect to those uses. Should any risk mitigation
measures identified in the assessment not subsequently be implemented,
EPA will revise the assessment as necessary to take those residues into
account.
    In June 2006, the Agency determined that 144 of the N-methyl
carbamate tolerances were insignificant contributors to the overall
dietary exposure to the N-methyl carbamates. The uses associated with
these 144 tolerances make an insignificant contribution to the overall
N-methyl carbamate cumulative risk. Therefore, EPA counted these
tolerances as reassessed before the final N-methyl carbamate cumulative
assessment was issued. That determination is not changed by the
assessment the Agency is now issuing. As noted in the previous
paragraph above, EPA has now determined that those tolerances assessed
in the N-methyl carbamate cumulative risk assessment meet the FFDCA
safety standard and that no further dietary risk mitigation is
necessary for any of the pesticides involved in the cumulative risk
assessment other than the mitigation measures identified in the
individual chemical or cumulative assessments.
    EPA is providing an opportunity, through this notice, for
interested parties to provide comments and input on the Agency's
completed cumulative risk assessment for the N-methyl carbamate
pesticides. Such comments and input could address the Agency's risk
assessment methodologies and assumptions as applied to this cumulative
assessment.
    The Agency will consider all comments received, and make changes,
if appropriate, to the N-methyl carbamate cumulative risk assessment.
    EPA seeks to achieve environmental justice, the fair treatment and
meaningful involvement of all people, regardless of race, color,
national origin, or income, in the development, implementation, and
enforcement of environmental laws, regulations, andpolicies. To help
address potential environmental justice issues, the Agency seeks
information on any groups or segments of the population who, as a
result of their location, cultural practices, or other factors, may
have atypical, unusually high exposure to N-methyl carbamate
pesticides, compared to the general population.
    EPA is applying the principles of public participation to all
pesticides undergoing reregistration and tolerance reassessment. The
Agency's Pesticide Tolerance Reassessment and Reregistration; Public
Participation Process, published in the Federal Register on May 14,
2004, (69 FR 26819) (FRL-7357-9) explains that in conducting these
programs, EPA is tailoring its public participation process to be
commensurate with the level of risk, extent of use, complexity of
issues, and degree of public concern associated with each pesticide.
The N-methyl carbamate pesticides have had extensive opportunities for
public comment as part of their reregistration and tolerance
reassessment process.
    Comments should be limited to issues raised within the N-methyl
carbamate cumulative risk assessment and associated documents. Failure
to comment on any such issues as part of this opportunity will not
limit a commenter's opportunity to participate in any later notice and
comment processes on this matter. All comments should be submitted
using the methods in ADDRESSES, and must be received by EPA on or
before the closing date. Comments will become part of the Agency Docket
for the N-methyl carbamate cumulative risk assessment. Comments
received after the close of the comment period will be marked < < late.''
EPA is not required to consider these late comments.

B. What is the Agency's Authority for Taking this Action?

    Section 4(g)(2)(A) of FIFRA, as amended, requires the Administrator
to make ``a determination as to the eligibility for reregistration (i)
for all active ingredients subject to reregistration under this section
for which tolerances or exemptions from tolerances are required under
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), not
later than the last date for tolerance reassessment established under
section 408(q)(1)(C) of that Act (21 U.S.C. 346a((q)(1)(C))...''
    Section 408(q) of the FFDCA, 21 U.S.C. 346a(q), requires EPA to
review tolerances and exemptions for pesticide residues in effect as of
August 2, 1996, to determine whether the tolerance or exemption meets
the requirements of section 408(b)(2) or (c)(2) of FFDCA. This review
is to be completed by August 3, 2006. A tolerance or exemption meets
the requirements of section 408(b)(2) or (c)(2), respectively, if ``the
Administrator determines the pesticide chemical residue is safe,''
i.e., ``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.'' 21 U.S.C. 346a(b)(2)(A), and
(c)(2)(A). In making this safety finding, FFDCA requires the
Administrator to consider, among other factors, ``available information
concerning the cumulative effects of such residues and other substances
that have a common mechanism of toxicity...'' 21 U.S.C.
346a(b)(2)(D)(v), and (c)(2)(B).

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: September 19, 2007.
Peter Caulkins,
Acting Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E7-18860 Filed 9-25-07; 8:45 am]

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