EPA REGISTRATION DIVISION - COMPANY NOTICE OF FILING FOR PESTICIDE PETITION

Docket ID Number: EPA-HQ-OPP-2016-0651

EPA Registration Division Contact: Sidney Jackson<PHONE_NUMBER>

Interregional Research Project Number 4

Pesticide Petition Number: 6E8510

   EPA has received a pesticide petition (PP), 6E8510, from the Interregional Research Project Number 4 (IR-4), IR-4 Project Headquarters, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ  08540 proposing in cooperation with Valent U.S.A. Corporation, 1600 Riviera Avenue, Suite 200, Walnut Creek, California 94596, 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 by:

 Establishing a tolerance for residues of the sum of clethodim, 2-[(1E)-1-[[[(2E)-3-chloro-2-propenyl]oxy]imino]propyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one, and its metabolites containing the 5-(2-ethylthiopropyl)cyclohexene-3-one and 5-(2-ethylthiopropyl)-5-hydroxycyclohexene-3-one moieties and their sulphoxides and sulphones, calculated as the stoichiometric equivalent of clethodim in or on the raw agricultural commodities Almond, hulls at 0.2 parts per million (ppm); Brassica, leafy greens, subgroup 4-16B at 3.0 ppm; Leaf petiole vegetable subgroup 22B at 0.60 ppm; Leafy greens subgroup 4-16A at 2.0 ppm; Nut, tree, group 14-12 at 0.2; Okra at 1.5 ppm;     Onion, green, subgroup 3-07B at 2.0 ppm; Stalk and stem vegetable subgroup 22A at 1.7 ppm; Vegetable, brassica, head and stem, group 5-16 at 3.0 ppm; and Vegetable, fruiting, group 8-10, except okra at 1.0 ppm; and

 Removing established tolerances for residues of the sum of clethodim, 2-[(1E)-1-[[[(2E)-3-chloro-2-propenyl]oxy]imino]propyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one, and its metabolites containing the 5-(2-ethylthiopropyl)cyclohexene-3-one and 5-(2-ethylthiopropyl)-5-hydroxycyclohexene-3-one moieties and their sulphoxides and sulphones, calculated as the stoichiometric equivalent of clethodim in or on the raw agricultural commodities Asparagus at  1.7 ppm; Brassica, head and stem, subgroup 5A at 3.0 ppm; Brassica, leafy greens, subgroup 5B at 3.0 ppm; Leaf petioles subgroup 4B at 0.60 ppm; Leafy greens subgroup 4A at 2.0 ppm; Onion, green at 2.0 ppm; Turnip, greens at 3.0 ppm; and Vegetable, fruiting, group 8-10 at 1.0 ppm.

EPA has determined that the petition contains data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition.  Additional data may be needed before EPA rules on the petition.

A.  Residue Chemistry

       Plant metabolism.  The metabolism of clethodim is adequately understood for the
      purpose of granting the proposed tolerances.

       Analytical method.  Practical analytical methods for detecting and measuring levels of clethodim have been developed and validated in/on all appropriate agricultural commodities and respective processing fractions.   The LOQ of clethodim in the methods is 0.2 ppm, which will allow monitoring of food with residues at the levels proposed for the tolerances.

       Magnitude of residues.  Residue data has been submitted which adequately support the requested tolerances.

B. Toxicological Profile

A summary of the toxicological endpoints for clethodim used for human risk assessment is discussed in EPA's January 30, 2014 Clethodim Preliminary Risk Assessment for Registration Review.  As noted the toxicology database for clethodim is complete and sufficient for selecting toxicity endpoints and points of departure (PODs) for risk assessment.  The acute reference dose (aRfD) of 1 mg/kg/day was calculated from the NOAEL from an acute neurotoxicity study and an uncertainty factor of 100X.  The chronic reference dose (cRfD) of 0.3 mg/kg/day was calculated from the NOAEL from the carcinogenicity study in mice and an uncertainty factor of 100X.  Clethodim is not carcinogenic so a cancer assessment was not performed.  The requirement for a subchronic inhalation study was waived by EPA (HASPOC, TXR 0056491, 2/20/2013).

C. Aggregate Exposure

 Dietary exposure.

      i.  Food. An acute and chronic dietary analysis was conducted to estimate exposure to potential clethodim residues in/on the following crops and food items: root and tuber vegetables, leaves of root and tuber vegetables, bulb vegetables, leafy vegetables, brassica leafy vegetables, legume vegetables (succulent and dry), fruiting vegetables, cucurbit vegetables, berries, cranberry, strawberry, asparagus, peanuts, cotton, sunflower, safflower, canola (rapeseed), flaxseed, hops, mint, sesame, basil, alfalfa, clover, field corn, and incurred secondary residues in meat, poultry, and milk.  All listed crops have approved tolerances, except for leaves of root and tuber vegetables.  EPA conducted a conservative unrefined assessment including tolerance levels residues and 100% crop treated were modeled with DEEM version 7.81 (G. Orrick, DP412704, 6/24/2013).
        The addition of the proposed uses to the approved uses of clethodim is expected to make a negligible incremental contribution to the dietary burden and therefore, the risk assessment has not been repeated to include these minor uses.

      ii.  Drinking water. Drinking water concentrations were calculated by the Environmental Fate and Effects Division (EFED) using Pesticide Root Zone Model Ground Water (PRZM GW).  The highly conservative maximum screening-level acute and chronic Estimated Drinking Water Concentrations (EDWCs) of 1.43 and 1.15 ug/L, respectively) from the alfalfa use pattern were used in the dietary assessment.  Details can be found in EPA's January 30, 2014 Clethodim Preliminary Risk Assessment for Registration Review.

         a.  Acute Dietary (Food and Drinking Water) Exposure Results and Characterization  - Based on EPA's January 30, 2014 Clethodim Preliminary Risk Assessment for Registration Review, Dietary Risk Estimates (Food + Drinking Water), the acute dietary (food and drinking water) exposure is estimated at 10% of the acute Population Adjusted Dose (aPAD) for the general U.S. population and 29% of the aPAD for all infants (<1 year old), the population subgroup with the highest estimated acute dietary exposure to clethodim.

         b.  Chronic Dietary (Food and Drinking Water) Exposure Results and Characterization  -  Based on EPA's January 30, 2014 Clethodim Preliminary Risk Assessment for Registration Review, the chronic dietary (food and drinking water) exposure assessment is estimated at 12% of the chronic Population Adjusted Dose (cPAD) for the general U.S. population and 30% of the cPAD for all infants (<1 year old), the population subgroup with the highest estimated chronic dietary exposure to clethodim.

2.  Non-dietary exposure.  Clethodim is currently registered for use on several agricultural crops and a variety of non-food uses, including residential landscaped areas.  EPA noted in its 2014 Preliminary Risk Assessment for Registration Review short term residential exposure to Clethodim may occur from ornamental plants beds, landscapes, trees, shrubs and ground cover. The results of the aggregate assessment (food, water and residential) indicate that total short-term aggregate margins of exposure (MOEs) are not of concern (i.e. an MOE >= 100) with baseline attire (shorts, short-sleeved shirt, shoes and socks).

D. Cumulative Effects

Section 408(b)(2)(D)(v) requires that the Agency must consider "available information" concerning the cumulative effects of a particular pesticide's residues and "other substances that have a common mechanism of toxicity." EPA does not have, at this time, available data to determine whether clethodim has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment.  For the purposes of this tolerance action, EPA has not assumed that clethodim has a common mechanism of toxicity with other substances.

E. Safety Determination

FFDCA section 408 provides that EPA shall apply an additional margin of safety, up to ten-fold, for added protection for infants and children in the case of threshold effects, unless EPA determines that a different margin of safety will be safe for infants and children.  The toxicological database for evaluating prenatal and postnatal toxicity for clethodim is complete with respect to current data requirements, and there are no special prenatal or postnatal toxicity concerns for infants and children.  EPA has concluded that reliable data support reduction of the FQPA Safety Factor for protection of infants and children to 1X.

       U.S. population.
Based on EPA's January 30, 2014 Clethodim Preliminary Risk Assessment for Registration Review, Dietary Risk Estimates (Food + Drinking Water), the acute and chronic dietary (food and drinking water) exposure is estimated at 10% and 12% of the acute and chronic Population Adjusted Dose, respectively, for the general U.S. population.  Aggregate exposures below 100% of the cPAD are generally considered to represent a reasonable certainty of no harm to exposed populations.  Valent USA concludes that there is a reasonable certainty that no harm will result to the U.S. population (or any sub-populations) by including the incremental additional exposure resulting from the proposed uses of clethodim.

       Infants and children.  Based on EPA's January 30, 2014 Clethodim Preliminary Risk Assessment for Registration Review, Dietary Risk Estimates (Food + Drinking Water), the acute and chronic dietary (food and drinking water) exposure is estimated at 29% and 30% of the acute and chronic Population Adjusted Dose, respectively, for the general U.S. population.  Aggregate exposures below 100% of the cPAD are generally considered to represent a reasonable certainty of no harm to exposed populations.  Valent USA concludes that there is a reasonable certainty that no harm will result to the U.S. population (or any sub-populations) by including the incremental additional exposure resulting from the proposed uses of clethodim.

F. International Tolerances

The U.S. residue definition is harmonized with Codex, but not Canada.  Canada's tolerance expression includes clethodim and its metabolites containing the 2-cyclohex-1-enone moiety, but does not include the sulphoxides and sulphones.

The following Codex Maximum Residue Limits (MRL) have been established for clethodim.

                                   Commodity
                                Codex MRL (ppm)
Bean, dry
                                      2.0
Onion, bulb, subgroup 3-07A
                                      0.5
Peanut
                                      5.0
Potato
                                      0.5
Sugar beet, roots
                                      0.1
Sunflower, seed
                                      0.5
Tomato
                                      1.0


[Federal Register Volume 80, Number 192 (Monday, October 5, 2015)]
[Notices]
[Pages 60207-60208]
[FR Doc No: 2015-25183]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76021; File No. SR-NYSEARCA-2013-107]

Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting an
Extension to Limited Exemption From Rule 612(c) of Regulation NMS in
Connection With the Exchange's Retail Liquidity Program Until March 31,
2016

September 29, 2015.
    On December 23, 2013, the Securities and Exchange Commission
(``Commission'') issued an order pursuant to its authority under Rule
612(c) of Regulation NMS (``Sub-Penny Rule'') \1\ that granted NYSE
Arca, Inc. (``Exchange'') a limited exemption from the Sub-Penny Rule
in connection with the operation of the Exchange's Retail Liquidity
Program (``Program'').\2\ The limited exemption was granted
concurrently with the Commission's approval of the Exchange's proposal
to adopt the Program for a one-year pilot term.\3\ The exemption was
granted coterminous with the effectiveness of the pilot Program; both
the pilot Program and exemption are scheduled to expire on September
30, 2015.\4\
---------------------------------------------------------------------------

    \1\ 17 CFR 242.612(c).
    \2\ See Securities Exchange Act Release No. 71176 (December 23,
2013), 78 FR 79524 (December 30, 2013) (SR-NYSEARCA-2013-107)
(``Order'').
    \3\ See id.
    \4\ The pilot term of the Program was originally scheduled to
end on April 14, 2015, but the Exchange extended the term through
September 30, 2015. See Securities Exchange Act Release No. 74572
(March 24, 2015), 80 FR 16705 (March 30, 2015) (NYSEARCA-2015-22).
When the pilot term of the Program was extended, the Commission
granted the Exchange's requests to also extend the Sub-Penny
exemption through September 30, 2015. See Securities Exchange Act
Release No. 74609 (March 30, 2015), 80 FR 18272 (April 3, 2015).
---------------------------------------------------------------------------

    The Exchange now seeks to extend the exemption until March 31,
2016.\5\ The Exchange's request was made in conjunction with an
immediately effective filing that extends the operation of the Program
through the same date.\6\ In its request to extend the exemption, the
Exchange notes that the participation in the Program has increased more
recently. Accordingly, the Exchange has asked for additional time to
allow itself and the Commission to analyze more robust data concerning
the Program, which the Exchange committed to provide to the
Commission.\7\ For this reason and the reasons stated in the Order
originally granting the limited exemption, the Commission finds that
extending the exemption, pursuant to its authority under Rule 612(c) of
Regulation NMS, is appropriate in the public interest and consistent
with the protection of investors.
---------------------------------------------------------------------------

    \5\ See Letter from Martha Redding, Assistant Secretary, NYSE,
to Brent J. Fields, Secretary, Securities and Exchange Commission,
dated September 17, 2015.
    \6\ See Securities Exchange Act Release No. 75994 (September 28,
2015),--FR--(SR-NYSEARCA-2015-84).
    \7\ See Order, supra note 2, 78 FR at 79529.
---------------------------------------------------------------------------

    Therefore, it is hereby ordered that, pursuant to Rule 612(c) of
Regulation NMS, the Exchange is granted a limited exemption from Rule
612 of Regulation NMS that allows it to accept and rank orders priced
equal to or greater than $1.00 per share in increments of $0.001, in
connection with the operation of its Retail Liquidity Program, until
March 31, 2016.
    The limited and temporary exemption extended by this Order is
subject to modification or revocation if at any time, the Commission
determines that such action is necessary or appropriate in furtherance
of the purposes of the Securities Exchange Act of 1934. Responsibility
for compliance with any applicable provisions of the Federal securities
laws must rest with the

persons relying on the exemption that is the subject of this Order.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(83).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-25183 Filed 10-2-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: July 2, 2008 (Volume 73, Number 128)]
[Notices]
[Page 38000-38001]
[DOCID:fr02jy08-118]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58020; File No. SR-ISE-2008-48]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change To Extend the Short Term Options Series Pilot Program

June 25, 2008.
    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 June 23, 2008, the International Securities Exchange, LLC
(``Exchange'' or ``ISE'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I and II below, which Items have been substantially prepared by
the Exchange. The Exchange has designated this proposal as non-
controversial under Section 19(b)(3)(A)(iii) of the Act \3\ and Rule
19b-4(f)(6) thereunder,\4\ which renders the proposed rule change
effective upon filing with the Commission. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    The ISE proposes to amend its rules to extend the Short Term
Options Series Pilot Program (``Pilot Program'') for an additional
year. The text of the proposed rule change is available on the
Exchange's Web site (http://www.ise.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
    On July 12, 2005, the Commission approved the Pilot Program that
allows ISE to list and trade options series that expire one week after
being opened for trading (``Short Term Options Series'').\5\ Under the
terms of the Pilot Program, the Exchange can select up to five options
classes on which Short Term Options Series may be opened on any Short
Term Options Series opening date. The Exchange also may list Short Term
Options Series on any options class selected by other securities
exchanges employing a similar pilot program under their respective
rules.
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 52012 (July 12,
2005), 70 FR 41246 (July 18, 2005) (SR-ISE 2005-17).
---------------------------------------------------------------------------

    The Pilot Program was subsequently extended \6\ and the current
Pilot Program is set to expire on July 12, 2008.\7\ The purpose of this
proposed rule change is to extend the Pilot Program for an additional
year. The Exchange believes that Short Term Options Series provide
investors with a flexible and valuable tool to manage risk exposure,
minimize capital outlays, and be more responsive to the timing of
events affecting the securities underlying options contracts. Although
ISE has not listed any Short Term Options Series during the Pilot
Program, there has been investor interest in trading short term options
at the Chicago Board Options Exchange. For competitive reasons and in
order to have the ability to respond to customer interest in Short Term
Options Series, the Exchange proposes to extend its Pilot Program.
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 54117 (July 10,
2006), 71 FR 40564 (July 17, 2006) (SR-ISE 2006-37).
    \7\ See Securities Exchange Act Release No. 56047 (July 11,
2007), 72 FR 39106 (July 17, 2007) (SR-ISE 2007-54).
---------------------------------------------------------------------------

    In the original proposal to establish the Pilot Program, the
Exchange stated that if it were to propose an extension or an expansion
of the Pilot Program, the Exchange would submit, along with any filing
proposing such amendments to the Pilot Program, a report (``Pilot
Program Report'') analyzing the Pilot Program, which would cover the
entire period during which the Pilot Program was in effect. Since the
Exchange has not listed any Short Term Options Series under the Pilot
Program, there is no data available to compile such a report at this
time. Therefore, the Exchange is not submitting a Pilot Program Report
with this proposal.
    Finally, the Exchange represents that it has the necessary systems
capacity to support the listing of Short Term Options Series should it
determine to do so in the future.
2. Statutory Basis
    The Exchange believes that short-term options series increase the
variety of listed options available to investors and provide investors
with a valuable tool to manage risk exposure, minimize capital outlays
and be more responsive to the timing of events affecting the securities
underlying options contracts. For these reasons, the Exchange believes
the proposed rule change is consistent with

Section 6(b) of the Act.\8\ Specifically, the Exchange believes the
proposed rule change is consistent with Section 6(b)(5) of the Act,\9\
which requires that the rules of an exchange be designed to promote
just and equitable principles of trade, serve to remove impediments to
and perfect the mechanism for a free and open market and a national
market system, and, in general, to protect investors and the public
interest.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78(f)(b).
    \9\ 15 U.S.C. 78(f)(b)(5).
---------------------------------------------------------------------------

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

    The Exchange believes that 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.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    The Exchange has designated the proposed rule change as one that:
(1) Does not significantly affect the protection of investors or the
public interest; (2) does not impose any significant burden on
competition; and (3) does not become operative for 30 days from the
date of filing, or such shorter time as the Commission may designate if
consistent with the protection of investors and the public interest.
Therefore, the foregoing rule change has become effective pursuant to
Section 19(b)(3)(A) of the Act \10\ and subparagraph (f)(6) of Rule
19b-4 thereunder.\11\
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to provide the Commission
with written notice of its intent to file the proposed rule change,
along with a brief description and text of the proposed rule change,
at least five business days prior to the date of filing of the
proposed rule change, or such shorter time as designated by the
Commission. The Exchange has fulfilled this requirement.
---------------------------------------------------------------------------

    The Exchange has asked the Commission to waive the operative delay
to permit the proposed rule change to become operative prior to the
30th day after filing. The Commission has determined that waiving the
30-day operative delay of the Exchange's proposal is consistent with
the protection of investors and the public interest and will promote
competition because such waiver will allow ISE to continue the existing
Pilot Program without interruption.\12\ Therefore, the Commission
designates the proposal operative upon filing.
---------------------------------------------------------------------------

    \12\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File No. SR-ISE-2008-48 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2008-48. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File No. SR-ISE-2008-48 and should be
submitted on or before July 23, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Acting Secretary.
 [FR Doc. E8-14927 Filed 7-1-08; 8:45 am]

BILLING CODE 8010-01-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products and a seller of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing comments on these important questions is limited. Our industry must have
more time to do research and study this product.  We need to make the general public aware of this revolutionary invention andtake the time to actually let people know that this product is an alternative to tobacco, not a tobacco product.  If nicotine isgoing to lumpted into the tobacco industry than you will have to let the tomato, potato and green pepper industry that they willhave to limit the sale of their products due to the fact that they carry natural nicotine in them. I mean really, let's get realabout this already and take the time to give this a chance because tobacco in the past and vaporizers are our future. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many yearsto even come up with idea of this Proposed Rule, so I do not think it is at all unreasonable to allow the public more time toget more research done and to comment on it.

This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes and vaporizers as an alternative to combustible cigarettes. Quite simply, I firmly
believe that they saved my life and the lives of so many. I wish these had been around 20 years ago, then maybe our great
grandparents would still be alive and dead from lung cancer because of second hand smoke. I wish to provide you with my
personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.


[Federal Register Volume 88, Number 190 (Tuesday, October 3, 2023)]
[Proposed Rules]
[Pages 68033-68035]
[FR Doc No: 2023-21754]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2023-0532]
RIN 1625-AA09

Drawbridge Operation Regulation; Sloop Channel, Nassau County, NY

AGENCY: Coast Guard, Department of Homeland Security (DHS).

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes to temporarily modify the operating
schedule that governs the Meadowbrook State Parkway Bridge, mile 12.8,
across Sloop Channel, Nassau County, NY. The bridge owner, New York
State Department of Transportation (NYSDOT), submitted a request to
operate the bridge under single leaf openings to perform bridge deck
replacement. We invite your comments on this proposed rulemaking.

DATES: Comments and relate material must reach the Coast Guard on or
before November 2, 2023.

ADDRESSES:  You may submit comments identified by docket number USCG-
2023-0532 using Federal Decision Making Portal at https://www.regulations.gov.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or email Ms. Stephanie E. Lopez, First Coast Guard District,
Project Officer, telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations [Delete/Add Any Abbreviations Not Used/Used
in This Document]

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
OMB Office of Management and Budget
NPRM Notice of Proposed Rulemaking (Advance, Supplemental)
Sec.  Section
U.S.C. United States Code
NYSDOT New York State Department of Transportation

II. Background, Purpose and Legal Basis

    The Meadowbrook State Parkway Bridge across Sloop Channel, mile
12.8, Nassau County, NY, has a vertical clearance of 21 feet at mean
high water and a horizontal clearance of 75.5 feet at mean high water.
Waterway users include recreational and commercial vessels, including
fishing vessels.
    The existing drawbridge operating regulations are listed at 33 CFR
117.799(h). NYSDOT is requesting a temporary rulemaking to operate
under single leaf openings while they perform bridge deck replacements.
NYSDOT has reached out to local mariners and notified them of the
proposed temporary rulemaking as well as outlined an alternate route
for larger vessels that may not be able to make passage under the
bridge with single leaf openings.

III. Discussion of Proposed Rule

    The Meadowbrook State Parkway Bridge will continue to operate under
its regular operating schedule found in 33 CFR 117.799(f). However,
this proposed rule when made final would allow the

bridge to operate under single leaf openings until May 15, 2024. For
vessels that are too large for single leaf openings NYSDOT has set an
alternate route. Vessels that can pass without requesting a bridge
opening may do so. NYSDOT has reached phase 2 of the project which
requires replacing the bridge deck. The reason for this request is to
allow the project to progress while minimizing impact on mariners.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive Orders related to rulemaking. Below we summarize our
analyses based on these statutes and Executive Orders.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This proposed rule has not been designated a
``significant regulatory action,'' under section 3(f) of Executive
Order 12866, as amended by Executive Order 14094 (Modernizing
Regulatory Review). Accordingly, the NPRM has not been reviewed by the
Office of Management and Budget (OMB).
    This regulatory action determination is based on the ability of
vessels to still transit the bridge under singe leaf openings or may
transit through an alternate route.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
bridge may be small entities, for the reasons stated in section IV.A.
above, this proposed rule would not have a significant economic impact
on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section. The Coast Guard will not retaliate against small entities that
question or complain about this proposed rule or any policy or action
of the Coast Guard.

C. Collection of Information

    This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132
(Federalism), if it has a substantial direct effect on the States, on
the relationship between the National Government and the States, or on
the distribution of power and responsibilities among the various levels
of government. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175 (Consultation and Coordination with Indian Tribal
Governments) because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this proposed rule has implications for federalism or
Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule will not
result in such an expenditure, we do discuss the effects of this
proposed rule elsewhere in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01, Rev.1, associated implementing
instructions, and Environmental Planning Policy COMDTINST 5090.1
(series), which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f). The
Coast Guard has determined that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule promulgates the
operating regulations or procedures for drawbridges. Normally such
actions are categorically excluded from further review, under paragraph
L49, of Chapter 3, Table3-1 of the U.S. Coast Guard Environmental
Planning Implementation Procedures.
    Neither a Record of Environmental Consideration nor a Memorandum
for the Record are required for this rule. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this proposed rule.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    Submitting comments. We encourage you to submit comments through
the Federal Decision-Making Portal at https://www.regulations.gov. To
do so, go to https://www.regulations.gov, type USCG-2023-0532 in the
search box and click ``Search.'' Next, look for this document in the
Search Results column, and click on it. Then click on the Comment
option. If your material cannot be submitted using https://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION
CONTACT section of this document for alternate instructions.
    Viewing material in docket. To view documents mentioned in this
proposed

rule as being available in the docket, find the docket as described in
the previous paragraph, and then select ``Supporting & Related
Material'' in the Document Type column. Public comments will also be
placed in our online docket and can be viewed by following instructions
on the https://www.regulations.gov Frequently Asked Questions web page.
Also, if you click on the'' Dockets'' tab and then the proposed rule,
you should see a ``Subscribe'' option for email alerts. Selecting this
option will enable notifications when comments are posted, or if/when a
final rule is published.
    We review all comments received, but we will only post comments
that address the topic of the proposed rule. We may choose not to post
off-topic, inappropriate, or duplicate comments that we receive.
    Personal information. We accept anonymous comments. Comments we
post to https://www.regulations.gov will include any personal
information you have provided. For more about privacy and submissions
in response to this document, see DHS's eRulemaking System of Records
notice (85 FR 14226, March 11, 2020).

List of Subjects in 33 CFR Part 117

    Bridges.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority:  33 U.S.C. 499; 33 CFR 1.05-1; DHS Delegation No.
0170.1, Revision No. 01.3.

0
2. Amend Sec.  117.799 by:
0
a. Staying paragraph (h) until 3:30 p.m. on May 15, 2024.
0
b. Adding paragraph (k).
    The addition to read as follows:

Sec.  117.799  Long Island, New York Inland Waterway from East Rockaway
Inlet to Shinnecock Canal.

* * * * *
    (k) The draw of the Meadowbrook State Parkway Bridge across Sloop
Channel, mile 12.8, shall operate on single leaf openings until May 15,
2024. The draw will open for commercial vessels engaged in commerce and
shall open Monday through Friday from 6:20 a.m. to 9:50 a.m. and 3:20
p.m. to 7:20 p.m. on signal at 20 and 50 minutes after the hour, and on
signal at all other times. For all other vessels, the draw shall open
on Monday thru Friday from 6:20 a.m. to 7:20 p.m. on signal at 20 and
50 minutes after the hour, and the draw shall open on Saturday, Sunday,
and Federal holidays from 7:20 a.m. to 8:20 p.m. on signal at 20 and 50
minutes after the hour, and on signal at all other times.

    Dated: August 21, 2023.
J.W. Mauger,
Rear Admiral, U.S. Coast Guard, Commander, First Coast Guard District.
[FR Doc. 2023-21754 Filed 9-28-23; 4:15 pm]
BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 150 (Friday, August 3, 2012)]
[Rules and Regulations]
[Page 46286]
[FR Doc No: 2012-19001]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2012-0678]

Drawbridge Operation Regulations; Mystic River, Mystic, CT

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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

SUMMARY: The Commander, First Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
Route 1 Bridge across the Mystic River, mile 2.8, at Mystic,
Connecticut. The deviation is necessary to facilitate bridge
rehabilitation repairs at the bridge. Under this deviation the bridge
may remain in the closed position November through April.

DATES: This deviation is effective from November 1, 2012 through April
15, 2013.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2012-0678 and are available online
at www.regulations.gov, inserting USCG-2012-0678 in the ``Keyword'' and
then clicking ``Search''. They are also available for inspection or
copying at the Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Ms. Judy K. Leung-Yee, Project Officer, First Coast Guard
District, telephone<PHONE_NUMBER><EMAIL_ADDRESS>If you
have questions on viewing the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Route 1 Bridge across the Mystic River
at mile 2.8, has a vertical clearance of 4 feet at mean high water and
7 feet at mean low water. The drawbridge operation regulations are
listed at 33 CFR 117.211.
    The normal waterway users are predominantly recreational craft of
various sizes.
    The Coast Guard issued two previous temporary deviations, (75 FR
78163) effective from December 2, 2010 through April 15, 2011 and (76
FR 70348) effective from December 1, 2011 through April 15, 2012, to
facilitate this major bridge rehabilitation project that allowed the
Route 1 Bridge to remain closed during the winter months when the
bridge rarely opens. Both previous temporary deviations achieved
successful results without any problems or complaints from the mariners
that normally transit the Mystic River.
    The owner of the bridge, Connecticut Department of Transportation,
has requested a third temporary deviation from the regulations to allow
the bridge to remain in the closed position to complete rehabilitation
repairs at the bridge.
    Under this temporary deviation the Route 1 Bridge may remain in the
closed position from November 1, 2012 through April 15, 2013, to
facilitate completion of bridge rehabilitation repairs. Vessels that
can pass under the bridge in the closed position may do so at any time.
    The bridge has received few requests to open during this time
period during the past three years. The waterway users were advised of
the requested bridge closure and no objections were received.
    In accordance with 33 CFR 117.35(e), the bridge must return to its
regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: July 25, 2012.
Gary Kassof,
Bridge Program Manager, First Coast Guard District.
[FR Doc. 2012-19001 Filed 8-2-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 84, Number 37 (Monday, February 25, 2019)]
[Notices]
[Pages 6038-6039]
[FR Doc No: 2019-03333]

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

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

TIME AND DATE:  2:00 p.m. on Thursday, February 28, 2019.

PLACE:  The meeting will be held at the Commission's headquarters, 100
F Street NE, Washington, DC 20549.

STATUS:  This meeting will be closed to the public.

MATTERS TO BE CONSIDERED:  Commissioners, Counsel to the Commissioners,
the Secretary to the Commission, and recording secretaries will attend
the closed meeting. Certain staff members who have an interest in the
matters also may be present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) and (10) and 17 CFR
200.402(a)(3), (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and (a)(10),
permit consideration of the scheduled matters at the closed meeting.
    Commissioner Peirce, as duty officer, voted to consider the items
listed for the closed meeting in closed session.
    The subject matters of the closed meeting will be:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings;
    Resolution of litigation claims; and
    Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.

CONTACT PERSON FOR MORE INFORMATION:  For further information and to
ascertain what, if any, matters have been added, deleted or postponed;
please contact Brent J. Fields from the Office of the Secretary at
(202) 551-5400.

    Dated: February 21, 2019.
Brent J. Fields,
Secretary.
[FR Doc. 2019-03333 Filed 2-21-19; 4:15 pm]
 BILLING CODE 8011-01-P


Burden item
                                      (A)
                                      (B)
                                      (C)
                                      (D)
                                      (E)
                                      (F)
                                      (G)
                                      (H)

                          Average hours per activity
                 Number of activities per year per respondent
                  Technical hours per year per respondent [a]
          Technical hours per year per respondent for wastewater [a]
              Estimated technical hours per year
(E=Cx265+Dx80)
                Estimated managerial hours per year
(F=Ex0.05)
                  Estimated clerical hours per year
(G=Ex0.1)
                          Total cost per year ($) [b]
1.  Familiarize with regulatory requirements
                                     3.61
                                      23
                                      69
                                      14
                                    19,405
                                    970.25
                                    1,940.5
                                                                 $2,344,715.85
2.  Plan activities
                                     6.08
                                      13
                                      61
                                      18
                                    17,605
                                    880.25
                                    1,760.5
                                                                 $2,127,220.95
3.  Training
                                     5.25
                                       4
                                      17
                                       4
                                     4,825
                                    241.25
                                     482.5
                                                                   $583,007.16
4.  Creation, testing, research, and development
                                     17.85
                                      99
                                     1,617
                                      150
                                    440,505
                                   22,025.25
                                   44,050.5
                                                                $53,226,439.40
5.  Gather information, monitor/inspect
                                      2.5
                                      677
                                     1,693
                                       0
                                    448,645
                                   22,432.25
                                   44,864.5
                                                                $54,209,999.67
6.  Process/compile and review
                                      20
                                       1
                                      20
                                       0
                                     5,300
                                      265
                                      530
                                                                   $640,401.65
7.  Complete reports
                                     81.2
                                       5
                                      388
                                      18
                                    104,260
                                     5,213
                                    10,426
                                                                $12,597,787.93
8.  Record/disclose
                                     17.46
                                      26
                                      442
                                      12
                                    118,090
                                    5,904.5
                                    11,809
                                                                $14,268,873.75
9.  Store/file
                                     6.77
                                      35
                                      222
                                      15
                                    60,030
                                    3,001.5
                                     6,003
                                                                 $7,253,454.92
TOTAL ANNUAL BURDEN AND COST (rounded)

                                   1,400,000
                                                                  $147,000,000
TOTAL CAPITAL AND O&M COST (rounded)

                                                                   $74,400,000
GRAND TOTAL (rounded)

                                                                  $221,000,000

Assumptions:
(a) = (c + d)/(b).
(c) - there are 265 existing sources out of the 345 total that will continue to comply with the HON.
(d) - the 80 facilities complying with the CAR will still be required to comply with HON requirements for wastewater.
Totals have been rounded to 3 significant figures. Figures may not add exactly due to rounding.
See Attachment I for assumptions and further description of activities.
                                 Attachment H

Assumptions and Item Descriptions for Attachment F:  Table F-12

Assumptions:

     (A) That all existing and new sources must submit an initial report within 120 days of promulgation and an implementation plan or permit application within 12 or 18 months of the compliance date.  It is assumed that initial reports and implementation plans have been submitted for existing sources and these reports are only required for new sources.  The new sources are most likely to be collocated within existing plants and be included in those existing source reports.

    (B) That semiannual reports of results from equipment leak detection and repair programs are required by the equipment leak standard.  Sources are required to comply with the equipment leak standard by 6 months after promulgation.  It is assumed that an average of 345 facilities will submit reports semiannually (345 existing facilities x 2 reports/facility = 690) (even those that use the CAR will still have to submit reports under the HON for wastewater).

Item Descriptions:

    (a) Average hours per activity are estimates of the specific activities and are the basis for estimating the overall burden.

    (b) Number of activities per year represents the number of reports expected to be reviewed and other related activities during the course of the year.  Under the performance test headings, these numbers are based upon assumptions (A) and (B), above.  For one-time reports, the total number of reports expected over the three-year period was divided by three to get an annual average incorporating assumption (B), above.

    (c) Estimated technical hours per year is the product of (a) and (b).

    (d) Estimated managerial hours per year is 5 percent of (c).

    (e) Estimated clerical hours per year is 10 percent of (c).

    (f) Annual cost per year is the sum of costs for technical, managerial, and clerical hours based on rates from the Office of Personnel Management (OPM), 2017 General Schedule, which excludes locality rates of pay.

                Managerial	$64.80 (GS-13, Step 5, $40.50 + 60%)
                Technical	$48.08 (GS-12, Step 1, $30.05 + 60%)
                 Clerical	$26.02 (GS-6, Step 3, $16.26 + 60%)

   (H[t] x $48.08/hour) + (H[m] x $64.80/hour) + (H[c] x $26.02/hour) = (G)

            Where:
                  H[t] is (c), or technical hours
                  H[m] is (d), or managerial hours, and
                  H[c] is (e), clerical hours

Report Review:

    1) Initial represents the EPA review of all initial reports received.

    2) Implementation plan or permit represents the EPA review of all implementation plans, or permit applications if submitted in lieu of an implementation plan.

    3) Compliance status represents compliance status verification by the EPA for the portions of the standard which a source must comply with before the compliance date (see assumption (A), above).

    4) Review equipment leak monitoring represents the review and screening of periodic reports received as a result of the equipment leaks standard.

    5) Notification of construction/reconstruction represents the EPA review of this notification from new sources.

    6) Notification of anticipated startup represents the EPA review of this notification from new sources.

    7) Notification of actual startup represents the EPA review of this notification from new sources.

    8) Notification of performance test represents the EPA review of this notification from new sources.

    9) Review of test results represents the EPA review of performance test results for new sources.

10) Review periodic reports represents the EPA review of periodic reports.

TOTAL ANNUAL BURDEN AND COST (ROUNDED) is the sum of columns (c), (d), and (e), and of (f), respectively. Totals have been rounded to 3 significant figures. Figures may not add exactly due to rounding.

                                 Attachment I

Assumptions and Item Descriptions for Attachment G:  Tables G-12 and G-13

Assumptions:

    (A) That there are 265 existing facilities out of 345 that will continue to comply with the HON, rather than the CAR.  The 80 facilities complying with the CAR will still be required to comply with the HON wastewater provisions, as the CAR does not include wastewater provisions.  The total number of facilities will increase by 5 new facilities per year.  Since new facilities must be in compliance at startup, the general periodic recordkeeping and reporting burdens are included, which accounts for the difference in the technical hours per facility.  No new facilities are expected to comply directly with the CAR.

    (B) That the average representative source, new and existing, will consist of the following points of burden:

            20 parameters to monitor at control devices throughout the facility
            10 affected storage tanks of various capacities
            3 affected major wastewater streams
            4 affected transfer rack operations
            3 overall leak detection and repair programs for 2,000 points
            1 emissions averaging program that involves 10 emission points
            1 facility wide inventory of emission points, Group 1 and Group 2
            8 process vents per facility

    (C) That there are 5 percent (0.05) managerial and 10 percent (0.10) clerical hours required for every technical hour.

    (D) That some activities necessary to generate reports involve creating records in the process, and that these activities are assumed to be reports activities alone, to avoid double counting these as records activities as well.  Therefore, only items 8 and 9 are considered records burdens directly.

Item Descriptions:

    (a) Average hours per activity is back-calculated by dividing (b) into (c).  Since the activities within each burden category can vary significantly, it is too inaccurate to assume an average to use to calculate (c).  Estimated activity technical hours are summarized to obtain (c) first, then back calculate for (a) with an estimated (b).

    (b) Number of activities per year per respondent represents the assumed typical number of separate activities a respondent may encounter during one year.  This number may vary from facility to facility, depending on consolidation of activities, collocated readings, etc.  Since so much variability exists, it is important to note that this is an estimate.  This number only was used to back-calculate (a).

    (c) Technical hours per year per respondent is the actual best estimate of the burden for each burden item.  The three-year separate activity burdens were divided by three, where appropriate, and then summarized to include in this column.  The technical hours for new respondents are higher because some periodic compliance reports and records are required at startup.  Existing respondents do not encounter these reporting and recordkeeping burdens for three years after promulgation.

    (d) Table G-12 Estimated number of new respondents reflects the number given in assumption (A), above.  Table G-13 Technical hours per year per respondent for wastewater are the annual technical hours associated with recordkeeping and reporting to ensure compliance with requirements for wastewater.  As discussed in assumption (A), facilities complying with the CAR will comply with HON wastewater requirements.  Burden hours per source, per emission type are shown in Table 5.

    (e) Estimated technical hours per year is the product of (c) and (d) for new facilities (Table G-12).  For Table G-13, estimated technical hours are the product of (c) and the number of existing facilities complying with all of the HON (265) added to the product of (d) and the number of facilities complying with only the wastewater provisions (80).

    (f) Estimated managerial hours per year is 5 percent of (e).

    (g) Estimated clerical hours per year is 10 percent of (e).

    (h) Annual cost per year is from the United States Department of Labor, Bureau of Labor Statistics, September 2016, Table 2. Civilian workers, by occupational and industry group.  The rates are from column 1, "Total Compensation."  The rates have been increased by 110 percent to account for the benefit packages available to those employed by private industry.
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
Managerial	$144.33 ($68.73 + 110%)
--------------------------------------------------------------------------------
Technical	$108.28 ($51.56 + 110%)
--------------------------------------------------------------------------------
Clerical	$53.34 ($25.40 + 110%)

  (H[t] x $108.28/hour) + (H[m] x $144.33/hour) + (H[c] x $53.34/hour) = (G)

            Where:
                  H[t] is (e), or technical hours
                  H[m] is (f), or managerial hours, and
                  H[c] is (g), clerical hours
--------------------------------------------------------------------------------

Report Review:

    1) Familiarize with regulatory requirements are the activities, less training, which involve comprehending the provisions in the standard and understanding how they apply to the respective points at a facility. We assume existing facilities will have to familiarize with the regulatory requirements each year.

    2) Plan activities represent such burdens as design, redesign, scheduling as well as drafting the implementation plan, and selecting methods of compliance.

    3) Training represents the portion (assumed 40 percent) of activities from 1) Familiarize with regulatory requirements for which an average facility would elect to provide class room instruction.  The standard does not require specific training itself.

    4) Creation, testing, research, and development are the activities involving testing, retesting, establishing operating range for parameters and analyzing point-by-point applicability.  Monitor related refit, calibration, and maintenance activities are also included under this heading.

    5) Gather information, monitor/inspect are the activities involving physical inspections of equipment, collection of monitored data, and other related activities.

    6) Process/compile and review are the activities that involve analysis of the information collected for accuracy, compliance, and appropriate reports and records required as a result.

    7) Complete reports represents the activities normally associated with filling out forms.  Since the standard requires no standard forms, these activities relate to the preparing of formal reports and cover letters as appropriate.

    8) Record/disclose are activities which are solely recordkeeping which occur once the appropriate report information has been extracted [see assumption (D), above].  These activities involve software translation, duplication, or archival processes normally associated with data management and storage common to this industry.

    9) Store/file again are activities which are solely recordkeeping which occur once the appropriate report information has been extracted [see assumption (D), above].  These activities involve the management life cycle of records, from the time they are filed and boxed up, to the time they are disposed.

TOTAL ANNUAL BURDEN AND COST (ROUNDED) is the sum of columns (e), (f), and (g), and of (h), respectively. Totals have been rounded to 3 significant figures. Figures may not add exactly due to rounding.

                                 Attachment J

Summary of Capital/Startup and Operation & Maintenance Costs for the CAR and Its Referencing Subparts

Note: Totals for capital and O&M costs have been rounded to 3 significant figures. Figures may not add exactly due to rounding.

NSPS Subpart Ka

      a.	Total Capital/Startup Cost of Monitoring Equipment:
            The total capital/Startup costs for this ICR are $0.

      b.	Total Cost of Operation and Maintenance of Monitoring Equipment:
            The total operating and maintenance (O&M) Costs for this ICR is $0.

      c.	Total Capital/Startup and O&M Cost:
            The total capital and O&M Costs are $0.

NSPS Subpart Kb

      a.	Total Capital/Startup Cost of Monitoring Equipment:
            The total capital/Startup costs for this ICR are $27,000.  This is the cost for 2 new storage tanks to install monitoring equipment associated with the CVS routed to a control device.  The storage tanks will use equipment similar to that used for Subparts NNN and III; therefore, the startup costs are approximately $13,500 per facility for a total of $27,000.  There are no capital/startup costs for the remaining 35 new storage tanks complying by either an IFR or EFR.

      b. 	Total Cost of Operation and Maintenance of Monitoring Equipment:
             The average annualized burden is estimated to be $1,350 per year per affected facility ($13,500 discounted over 10 years by straight line depreciation method) for both new (2) and existing affected sources (436) using CVS routed to a control device, for a total of $591,300.

      c.	Total Capital/Startup and O&M Cost:
            The total capital and O&M Costs are $618,000.

NSPS Subpart VV

      a.	Total Capital/Startup Cost of Monitoring Equipment:
            The capital/startup costs of this regulation are $0.  We assume facilities that are already complying with Subpart VV will not need to buy an additional monitor and that no additional facilities will become subject to Subpart VV in the future.

      b.	Total Cost of Operation and Maintenance of Monitoring Equipment:
            Operation of monitors is included in monitoring costs.  Maintenance costs for these units are incidental; therefore, no maintenance or operation costs will be incurred.

      c.	Total Capital/Startup and O&M Cost:
            The total capital and O&M Costs are $0.

NSPS Subpart VVa

      a.	Total Capital/Startup Cost of Monitoring Equipment:
            The capital/startup costs of this regulation total $4,200.  This is based on the average cost of a monitor ($7,000) with a 5-year expected life.  The equipment is not capitalized, so no discount rate applies.  The average annual cost is, therefore, $7,000/5, or $1,400/yr.  It is estimated that only area sources that construct new process units might purchase a monitoring instrument.  All other sources should have monitoring equipment because they are either subject to MACT rules or have been subject to NSPS Subpart VV for other processes.  We assume 38 process units are subject to NSPS Subpart VVa each year, where 60 percent of all new sources are newly constructed sources and 15 percent of all new sources are area sources.  Therefore, an estimated 3 facilities with a new process unit will buy a monitoring instrument to comply with NSPS Subpart VVa, yielding a total capital/startup cost of $1,400 x 3, or $4,200.

      b.	Total Cost of Operation and Maintenance of Monitoring Equipment:
            The operation of the monitors is included in the monitoring costs.  Maintenance costs on these units is incidental; therefore, no maintenance or operation costs incur.

      c.	Total Capital/Startup and O&M Cost:
            The total capital and O&M Costs are $4,200.

NSPS Subpart DDD

      a. 	Total Capital/Startup Cost of Monitoring Equipment:
            The capital/startup costs for this regulation are $300,000.  This is based on 10 new sources per year multiplied by $30,000 per source for monitoring equipment.

      b.	Total Cost of Operation and Maintenance of Monitoring Equipment:
            The annual operation and maintenance costs are $1,050,000.  This is based on 140 existing sources plus 10 new sources per year over the life of the ICR multiplied by $7,000 for upkeep of the monitoring devices.

      c.	Total Capital/Startup and O&M Cost:
            The total capital and O&M Costs are $1,350,000.

NSPS Subpart III

      a.	Total Capital/Startup Cost of Monitoring Equipment:
            The startup cost of monitoring equipment is approximately $13,500 per new affected facility or a total of $13,500 (based on 1 new source x $13,500/source).

      b.	Total Cost of Operation and Maintenance of Monitoring Equipment:
            The average annualized burden is estimated to be $1,350 per year per affected facility ($13,500 discounted over 10 years by straight line depreciation method) for Subpart III for a total of $22,950 ($1,350 x 17) total number of new and existing affected sources under Subpart III].

      c.	Total Capital/Startup and O&M Cost:
            The total capital and O&M Costs are $36,500.

NSPS Subpart NNN

      a.	Total Capital/Startup Cost of Monitoring Equipment:
            The startup cost of monitoring equipment is approximately $13,500 per new affected facility or a total of $2,389,500 (total of 177 new sources x $13,500/source).

      b.	Total Cost of Operation and Maintenance of Monitoring Equipment:
            The average annualized burden is estimated to be $1,350 per year per affected facility ($13,500 discounted over 10 years by straight line depreciation method) for Subpart NNN for a total of $3,249,450 [($1,350 x 2,407) total number of new and existing affected sources under Subpart NNN].

      c.	Total Capital/Startup and O&M Cost:
            The total capital and O&M Costs are $5,640,000.

NSPS Subpart RRR

      a.	Total Capital/Startup cost of Monitoring Equipment:
            The capital/startup costs for this regulation are $500,000 per year.  This is based on 20 new sources per year multiplied by $25,000 for monitoring equipment discounted over 10 years at 7 percent.

      b.	Total Cost of Operation and Maintenance of Monitoring Equipment:
            The annual operation and maintenance costs are $137,500.  This is based on 255 existing sources plus 20 new sources multiplied by $500 for upkeep of the monitoring device.

      c.	Total Capital/Startup and O&M Cost:
            The total capital/startup and O&M Costs are $638,000.

NESHAP Subpart BB

      a.	Total Capital/Startup cost of Monitoring Equipment:
            Startup costs were identified in previous ICR.

      b.	Total Cost of Operation and Maintenance of Monitoring Equipment:
            There are no O&M costs associated because no CEMs are employed.

      c.	Total Capital/Startup and O&M Cost:
            The total capital and O&M costs are $0.

NESHAP Subpart Y

      a.	Total Capital/Startup Cost of Monitoring Equipment:
            The only type of industry costs associated with the information collection activity in the standards is labor cost.  There are no capital/startup costs.

      b.	Total Cost of Operation and Maintenance of Monitoring Equipment:
            There are no operation and maintenance costs.

      c.	Total Capital/Startup and O&M Cost:
            The total capital and O&M costs are $0.

NESHAP Subpart V

      a.	Total Capital/Startup Cost of Monitoring Equipment:
            Startup cost were identified in previous ICR.

      b.	Total Cost of Operation and Maintenance of Monitoring Equipment:
            There are no O&M costs associated because no CEMs are employed.

      c.	Total Capital and O&M Cost
            The total capital and O&M costs are $0.

NESHAP HON:

Subpart G

      a.	Total Capital/Startup Cost of Monitoring Equipment:
            Estimate the cost to purchase monitoring equipment is approximately $20-30K for process vents and wastewater operations, or an average of $25K with a 10-year life expectancy and a 7 percent depreciation rate, or $2,225 per year.  There are no associated costs for transfer racks and storage tanks.  Only new sources need to buy monitoring equipment; therefore, the total capital/startup cost is $25,000 x 5, or $125,000.

      b.	Total Cost of Operation and Maintenance of Monitoring Equipment:
            The cost to industry associated with the operation and maintenance (O&M) is approximately $100-500K per year (capital/startup depreciation not included) for reactor process vents and wastewater operations.  The cost associated with the operation and maintenance is $50-100K per year (capital/startup depreciation not included) for distillation unit process vents.  There are no associated costs for transfer racks and storage tanks.  The average O&M cost is assumed to be the average of the two ranges, or $275,000 per year.  Operation and maintenance incur for both new and existing sources.  The total O&M is, therefore, $275,000 x 270, or $74,400,000.

      c.	Total Capital/Startup and O&M Cost:
            The total capital and O&M costs are $74,400,000.

Subpart H

      a.	Total Capital/Startup Cost of Monitoring Equipment:
            Only new sources will buy an organic volatile analyzer.  Estimate the average cost of a monitor is $7,000 with a 5-year expected life. The equipment is not capitalized, so no discount rate applies.  The average annual cost is, therefore, $7,000/5, or $1,400/yr.  Estimate that 80 percent of facilities contract out LDAR services, and 20 percent perform in-house.  Those facilities which contract out (4 facilities) will purchase one unit as backup; the remaining facilities performing LDAR in-house (1 facility) will purchase 5 units to support the program.  The total annual capital/startup cost is, therefore, 9 units x $1,400/unit, or $12,600/yr.

      b.	Total Cost of Operation and Maintenance of Monitoring Equipment:
            The operation of the monitors is included in the monitoring costs.  Maintenance costs on these units is incidental; therefore, no maintenance or operation costs are incurred.

      c.	Total Capital and O&M Cost for Subparts H:
            The total capital and O&M costs are $12,600.

Part 65 CAR

      a.	Total Capital/Startup Cost of Monitoring Equipment:
            Under the CAR, it is assumed all new sources start out under the referencing subpart.  Therefore, there is no capital/startup cost associated with this subpart.

      b.	Total Cost of Operation and Maintenance of Monitoring Equipment:
            The HON is the basis for determining O&M costs for the CAR.  The average cost per source, based on the HON is $275,000 per year, for a total of $22,000,000.

      c.	Total Capital/Startup and O&M Cost:
            The total capital and O&M costs are $22,000,000.


[Federal Register Volume 83, Number 77 (Friday, April 20, 2018)]
[Notices]
[Pages 17553-17554]
[FR Doc No: 2018-08333]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2013-0324; FRL-9974-73-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NESHAP for Marine Tank Vessel Loading
Operations (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR)--NESHAP for Marine Tank Vessel
Loading Operations (Renewal), EPA ICR Number 1679.10, OMB Control
Number 2060-0289--to the Office of Management and Budget (OMB) for
review and approval in accordance with the Paperwork Reduction Act.
This is a proposed extension of the ICR, which is currently approved
through April 30, 2018. Public comments were previously requested via
the Federal Register on June 29, 2017 during a 60-day comment period.
This notice allows for an additional 30 days for public comments. A
fuller description of the ICR is given below, including its estimated
burden and cost to the public. An Agency may neither conduct nor
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before May 21, 2018.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2013-0324, to: (1) EPA online using www.regulations.gov (our
preferred method), or by email to [email protected], or by mail to:
EPA Docket Center, Environmental Protection Agency, Mail Code 28221T,
1200 Pennsylvania Ave. NW, Washington, DC 20460; and (2) OMB via email
to [email protected]. Address comments to OMB Desk Officer
for EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI), or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Patrick Yellin, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-0050; email address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit: http://www.epa.gov/dockets.
    Abstract: The National Emission Standards for Hazardous Air
Pollutants (NESHAP) for Marine Tank Vessel Loading Operations (40 CFR
part 63, subpart Y) establishes Maximum Achievable Control Technology
(MACT) standards for existing facilities and new facilities that load
marine tank vessels with petroleum or gasoline. These facilities have
aggregate actual hazardous air pollutants (HAP) emissions of 10 tons or
more of each individual HAP, or 25 tons or more of all HAP combined.
This NESHAP regulation also established reasonably-available control
technology (RACT) standards to such facilities with an annual
throughput of 10 million or more barrels of gasoline or 200 million or
more barrels of crude oil. The NESHAP regulation was amended in 2011 to
include emission standards for two marine tank vessel loading operation
(MTVLO) subcategories not included in the original rule. These
subcategories are facilities with MTVLO that emit less than 10 tons per
year of each individual HAP and less than 25 tons per year of all HAP
combined, and that are located at major sources of HAP loading more
than 1 million barrels per year of gasoline, and facilities located
more than 0.5 miles from shore. The 2011 amendment also added a
provision to require electronic submittal of performance test results.
This ICR has been updated to reflect the additional industry burden
associated with the amended standards. The 2015 amendments did not add
information collection requirements beyond those currently required
under the applicable regulations.
    In general, all NESHAP standards require initial notifications,
performance tests, and periodic reports by the owners/operators of the
affected facilities. They are also required to maintain records of the
occurrence and duration of any startup, shutdown, or malfunction in the
operation of an affected facility or any period during which the
monitoring system is inoperative. These notifications, reports, and
records are essential in determining compliance, and are required of
all affected facilities subject to NESHAP. Any owner/operator subject
to the provisions of this part shall maintain a file of these
measurements, and retain the file for at least five years following the
date of such measurements, maintenance reports, and records. All
reports are sent to the delegated state or local authority. If there is
no such delegated authority, the reports are sent directly to the EPA
regional office.
    Form Numbers: None.
    Respondents/affected entities: Owners or operators of marine tank
vessel loading operations.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart Y).
    Estimated number of respondents: 804 (total).
    Frequency of response: Initially and annually.
    Total estimated burden: 10,700 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $1,130,000 (per year), which includes no
annualized capital/startup or operation & maintenance costs.
    Changes in the Estimates: There is a small increase in the total
estimated burden as currently identified in the OMB Inventory of
Approved Burdens. This adjustment is due to a change in a previous
assumption. In accordance with the Terms of Clearance for OMB's
previous approval, this ICR renewal

package assumes all existing respondents will have to familiarize with
the regulatory requirements each year. Additionally, there is a
decrease in the number of responses from 843 to 842 to remove the
affirmative defense requirement since those provisions have been
removed from the rule since the last renewal.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2018-08333 Filed 4-19-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: December 3, 2007 (Volume 72, Number 231)]
[Rules and Regulations]
[Page 67845-67847]
[DOCID:fr03de07-4]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-0269; Directorate Identifier 2007-NM-158-AD;
Amendment 39-15287; AD 2007-25-05]
RIN 2120-AA64

Airworthiness Directives; Airbus Model A330 Airplanes

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

ACTION: Final rule; request for comments.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    It has been discovered that a batch of sleeves and pins of the
Rolls-Royce Trent 700 Thrust Reverser Unit (TRU) hinge n[deg]
[number] 5 has not been subjected to the correct precipitation
hardening.
    This production quality issue, if not corrected, can lead to the
complete failure of the hinge n[deg] 5--the remaining hinges may not
sustain ultimate load--resulting in the worst case to the TRU
release from the pylon, which constitutes an unsafe condition.
    The degradation of the mechanical specifications of these parts
puts into question the current design life goal of these parts. * *
*

The unsafe condition is possible detachment of the thrust reverser unit
from the airplane, which could result in reduced controllability and
possible damage to the airplane. This AD requires actions that are
intended to address the unsafe condition described in the MCAI.

DATES: This AD becomes effective December 18, 2007.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication, listed in the AD as of December 18,
2007.
    We must receive comments on this AD by January 2, 2008.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov.
 Follow the instructions for submitting comments.

     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue, SE., Washington, Docket Operations office (telephone
(800) 647-5527) is in the ADDRESSES section. Comments will be available
in the AD docket shortly after receipt.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov
; or in person at the Docket Operations office

between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section.

FOR FURTHER INFORMATION CONTACT: Tim Backman, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,

1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-2797; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2007-0166, dated June 15, 2007 (referred to
after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    It has been discovered that a batch of sleeves and pins of the
Rolls-Royce Trent 700 Thrust Reverser Unit (TRU) hinge n[deg]
[number] 5 has not been subjected to the correct precipitation
hardening.
    This production quality issue, if not corrected, can lead to the
complete failure of the hinge n[deg] 5--the remaining hinges may not
sustain ultimate load--resulting in the worst case to the TRU
release from the pylon, which constitutes an unsafe condition.
    The degradation of the mechanical specifications of these parts
puts into question the current design life goal of these parts.
Consequently, the 2/2 sleeve and affected pin on the TRU hinge
n[deg] 5 must be removed from service by means of this AD.

The unsafe condition is possible detachment of the thrust reverser unit
from the airplane, which could result in reduced controllability and
possible damage to the airplane. The corrective action is removing the
affected sleeves and pins and replacing them with new, properly
hardened sleeves and pins. You may obtain further information by
examining the MCAI in the AD docket.

Relevant Service Information

    Airbus has issued Service Bulletin A330-78-3017, Revision 01, dated
May 3, 2007. The actions described in this service information are
intended to correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are issuing this AD because we
evaluated all pertinent information and determined the unsafe condition
exists and is likely to exist or develop on other products of the same
type design.
    There are no products of this type currently registered in the
United States. However, this rule is necessary to ensure that the
described unsafe condition is addressed if any of these products are
placed on the U.S. Register in the future.

Differences Between the AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the AD.

FAA's Determination of the Effective Date

    Since there are currently no domestic operators of this product,
notice and opportunity for public comment before issuing this AD are
unnecessary.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2007-0269; Directorate
Identifier 2007-NM-158-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may amend this AD because of
those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov
, including any personal information you provide. We

will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2007-25-05 Airbus: Amendment 39-15287. Docket No. FAA-2007-0269;
Directorate Identifier 2007-NM-158-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective December
18, 2007.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Airbus Model A330-243, -341, -342, and -
343 airplanes, certificated in any category, all serial numbers,
except those on which Airbus modification 56129 has been embodied in
production or Airbus Service Bulletin A330-78-3017 has been embodied
in service.

Subject

    (d) Air Transport Association (ATA) of America Code 78: Engine
Exhaust.

Reason

    (e) The mandatory continued airworthiness information (MCAI)
states:
    It has been discovered that a batch of sleeves and pins of the
Rolls-Royce Trent 700 Thrust Reverser Unit (TRU) hinge n[deg]
[number] 5 has not been subjected to the correct precipitation
hardening.
    This production quality issue, if not corrected, can lead to the
complete failure of the hinge n[deg] 5--the remaining hinges may not
sustain ultimate load--resulting in the worst case to the TRU
release from the pylon, which constitutes an unsafe condition.
    The degradation of the mechanical specifications of these parts
puts into question the current design life goal of these parts.
Consequently, the 2/2 sleeve and affected pin on the TRU hinge
n[deg] 5 must be removed from service by means of this AD.

The unsafe condition is possible detachment of the thrust reverser
unit from the airplane, which could result in reduced
controllability and possible damage to the airplane. The corrective
action is removing the affected sleeves and pins and replacing them
with new, properly hardened sleeves and pins.

Actions and Compliance

    (f) Within 13 months after the effective date of this AD, unless
already done, do the following actions, in accordance with the
Accomplishment Instructions of Airbus Service Bulletin A330-78-3017,
Revision 01, dated May 3, 2007. Actions done before the effective
date of this AD in accordance with Airbus Service Bulletin A330-78-
3017, dated January 24, 2007, are considered acceptable for
compliance with this paragraph.
    (1) Replace all sleeves of the thrust reverser unit hinge number
5 (left- and right-hand (LH and RH)) with new, properly hardened
sleeves.
    (2) Identify and replace all affected pins of the thrust
reverser unit hinge number 5 (LH and RH) with new, properly hardened
pins.

FAA AD Differences

    Note 1: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. Send information to ATTN: Tim
Backman, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act, the
Office of Management and Budget (OMB) has approved the information
collection requirements and has assigned OMB Control Number 2120-
0056.

Related Information

    (h) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2007-0166, dated June 15, 2007;
Airbus Service Bulletin A330-78-3017, dated January 24, 2007; Airbus
Service Bulletin A330-78-3017, Revision 01, dated May 3, 2007; and
Rolls-Royce Alert Service Bulletin RB.211-78-AF273, dated January 2,
2007, for related information.

Material Incorporated by Reference

    (i) You must use Airbus Service Bulletin A330-78-3017, Revision
01, dated May 3, 2007, to do the actions required by this AD, unless
the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Airbus, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France.
    (3) You may review copies at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, Washington; or at the
National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call<PHONE_NUMBER>,
or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html
.

    Issued in Renton, Washington, on November 23, 2007.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E7-23343 Filed 11-30-07; 8:45 am]

BILLING CODE 4910-13-P