[Federal Register: May 24, 2010 (Volume 75, Number 99)]
[Notices]
[Page 28841-28842]
[DOCID:fr24my10-97]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-62133; File No. SR-FINRA-2010-025]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing of Proposed Rule Change To Amend
FINRA Rule 6121 (Trading Halts Due to Extraordinary Market Volatility)

May 19, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on May 18, 2010, Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by FINRA. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA is proposing to amend FINRA Rule 6121 (Trading Halts Due to
Extraordinary Market Volatility) to permit FINRA to halt trading by
FINRA members otherwise than on an exchange where a primary listing
market has issued a trading pause due to extraordinary market
conditions.
    The text of the proposed rule change is available on FINRA's Web
site at http://www.finra.org, at the principal office of FINRA 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, FINRA 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. FINRA 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
    In October 2008, FINRA adopted FINRA Rule 6121 (Trading Halts Due
to Extraordinary Market Volatility) to permit FINRA to halt over-the-
counter (``OTC'') trading of NMS stocks \3\ if other major U.S.
securities markets initiate market-wide trading halts in response to
their rules or extraordinary market conditions or if otherwise directed
by the SEC.\4\ This proposed rule change was designed to further the
goal of coordinated self-regulatory organization (``SRO'') action to
address potentially destabilizing market volatility, consistent with
the circuit breaker trading halt authority of the exchanges.
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    \3\ NMS stock means any NMS security other than an option. See
SEC Rule 600 of Regulation NMS.
    \4\ See Securities Exchange Act Release No. 58753 (October 8,
2008), 73 FR 61177 (October 15, 2008) (Notice of Filing and
Immediate Effectiveness of File No. SR-FINRA-2008-048).
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    On May 18, 2010, several national securities exchanges filed new
rules with the Commission to provide the exchanges with authority to
issue trading pauses for individual securities if the price of such
security moves 10% or more from a sale in a preceding five-minute
period. These changes would provide uniform market-wide trading pause
standards for individual securities in the S&P 500[reg] Index that
experience a rapid price movement. Consistent with the exchanges'
proposals and in consultation with the staff of the Commission, FINRA
is proposing to amend FINRA Rule 6121 to add new Supplementary Material
.01 to provide that if a primary listing market has issued an
individual stock trading pause under its rules, FINRA will halt trading
otherwise than on an exchange in that security until trading has
resumed on the primary listing market. If, however, trading has not
resumed on the primary listing market and ten minutes have passed since
the individual stock trading pause message has been received from the
responsible single plan processor or the primary listing market has
issued notice that it cannot resume trading for a reason other than a
significant imbalance, FINRA may permit the resumption of trading
otherwise than on an exchange if trading has commenced on at least one
other national securities exchange.

Consistent with the exchanges, FINRA is proposing that this rule be
implemented as a pilot set to end on December 10, 2010, so that the
markets may assess the effect of the new rules on the markets. During
this pilot period, the rule would be in effect only with respect to
securities included in the S&P 500[supreg] Index.
    FINRA has requested that the Commission approve the proposed rule
change on an accelerated basis, so that it may become operative on June
7, 2010, and fully rolled out across all eligible securities by June
14, 2010.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\5\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade and, in general, to protect investors and the
public interest. FINRA believes that the proposed rule change is
consistent with the trading pause rules of other SROs and will promote
the goal of investor protection by further providing for a coordinated
means to address potentially destabilizing market volatility.
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    \5\ 15 U.S.C. 78o-3(b)(6).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

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

    Written comments were neither solicited nor received.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve such proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.\6\
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    \6\ The Commission notes that the exchange has requested
accelerated approval of the filing.
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2010-025 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-FINRA-2010-025. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room, 100 F
Street, NE., Washington, DC 20549, on official business days between
the hours of 10 a.m. and 3 p.m. Copies of such filing also will be
available for inspection and copying at the principal office of FINRA.
All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-FINRA-2010-025
and should be submitted on or before June 3, 2010.\7\
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    \7\ The Commission believes that a 10-day comment period is
reasonable, given the urgency of the matter. It will provide
adequate time for comment.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
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    \8\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-12426 Filed 5-21-10; 8:45 am]
BILLING CODE 8010-01-P


 1 COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE ( 9/ 1/ 99)

EPA Registration Division contact: Jim Tompkins , 703 305 5697 [ INSTRUCTIONS: Please utilize this outline in preparing tolerance petition documents. In cases where the outline element does not apply please insert ?

NA Remove ?

and maintain the outline. The comment notes that appear on the left margin represent hidden typesetting codes designed to expedite the processing of the Federal Register document. Please do not remove or alter these comment notes or change the margins, font, or format in your document. Simply replace the instructions that appear in italics and brackets, i. e., ?[ insert company name],? with the information specific to your action.

I. Nissan Chemical Industries, Ltd.

PP 0F6076 Summary of Petitions EPA has received a pesticide petition ( PP 0F6076) from Nissan Chemical Industries, Ltd ( Nissan), 7 1, 3 Chome, Kanda Nishiki Cho Chiyoda Ku, Tokyo 101 0054 Japan, proposing, pursuant to section 408( d) of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a( d), to amend 40 CFR part 180 Options ( pick one)

1. by establishing a tolerance for residues of quizalofop P ethyl in or on the raw agricultural commodities sunflower seeds at 2.0 parts per million ( ppm) flax seed at 0.05 ppm , wheat at 0.05 ppm and barley at 0.05 ppm. EPA has determined that the petition contains data or information regarding the elements set forth in section 408( d)( 2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry 1. Plant metabolism. Plant metabolism studies have been conducted for soybeans, cotton, tomatoes, potatoes, and sugar beets. These studies have been previously reviewed and accepted by EPA ( see PP# 3F4268). In summary, quizalofop P ethyl ester is metabolized by cleavage at three sites as follows.

1. Hydrolysis of the ethyl ester to form the quizalofop p acid ( primary pathway).

2. Cleavage of the enol ether linkage in the acid, between the phenyl and quinoxalinyl rings, to form 2 phenols.

3. Cleavage of the ether linkage between the isopropanic group and the phenyl ring to form a phenol.

The plant metabolism data show that the quizalofop P ethyl ester itself does not translocate, but is rapidly hydrolyzed to the corresponding acid. The phenols conjugate with the plant sugars. Metabolism studies in soybeans using the racemic mixture quizalofop ethyl ester and the resolved D+ isomer show nearly identical pathways.

The nature of the quizalofop P ethyl ester residue in cottonseed, potatoes, tomatoes, soybeans, and sugar beets is adequately understood. The residues of concern are quizalofop p ethyl ester and its acid metabolite, quizalofop p, and the S enantiomers of both the ester and the acid, all expressed as quizalofop p ethyl ester.

2. Analytical method. Data Collection Method. The analytical method ( MRID 44967703) used to collect sunflower and flax field and processing data is briefly described below.

The method involves refluxing samples with methanolic potassium hydroxide to convert quizalofop P ethyl and quizalofop P residues to 2 methoxy 6 chloroquinoxaline ( MeCHQ). The solution is then acidified and partitioned with hexane to extract the MeCHQ. The hexane fraction is cleaned up by gel permeation chromatography. The appropriate fraction is collected, concentrated and made up to final volume with hexane. Residues are quantified using normal phase high pressure liquid chromatography ( HPLC) with fluorescence detection. The limit of quantitation of the method is 0.05 ppm.

The analytical method used to collect wheat and barley field and processing data ( Report No. MLIR 02 01) is similar to the method used for flax and sunflower, but has a few modifications. The modified method requires a silica SPE purification for wheat and barley hay and straw matrices prior to GPC cleanup. The determination and quantitation of the MeCHQ is conducted using reverse phase HPLC with the fluorescence detection. The limit of quantitation of the method is still 0.05 ppm.

Independent Method Validation. The analytical method used for sunflower and flax data collection ( MRID 44967703) was subjected to an independent laboratory validation ( MRID 44967704). Untreated control sunflower seeds were fortified with quizalofop P ethyl and quizalofop P at 0.05 ppm and 2.00 ppm. The method was successfully validated for both analytes.

The analytical method used for wheat and barley data collection ( Report No. MLIR 02 01) was subjected to an independent laboratory validation ( Study No. EN CAS 01 0040). Each trial consisted of two subsets, one for quizalofop P ethyl and the other for quizalofop P. Each subset included two unfortified control samples and two fortifications at the Limit of Quantitation ( LOQ, 0.05 ppm), at 2X the LOQ ( 0.10 ppm) and at 6.5 ppm, the highest residue level found in a 3 related residue study. The method was successfully validated for both analytes and the results are shown in the following table.

3. Magnitude of residues.

Magnitude of the Residue   Sunflower Crop Field Trials Eight field trials were conducted in 1998 using various varieties of sunflowers ( MRID 44967701). Trial sites were located in Kansas ( 1 site), North Dakota ( 4 sites), South Dakota ( 2 sites), and Texas ( 1 site). Sunflower seeds were harvested 60 to 61 days following two postemergent applications ( 6 to 7 day spray interval) with an emulsifiable concentrate ( EC) formulation of quizalofop P ethyl. The target application rates were 0.0537 lb ai/ A for the first application and 0.0672 lb ai/ A for the second application.

Samples of seeds ( including hulls) were analyzed for residues of quizalofop P ethyl and quizalofop P, expressed as quizalofop P ethyl, using a validated analytical method ( Report No. SARS 98 06). The overall recoveries were 79% for quizalofop P ethyl and 87% for quizalofop P. The limit of quantitation was 0.05 ppm. The samples were stored frozen 28 to 136 days from collection to extraction.

The residues of quizalofop P ethyl and quizalofop P ( expressed as quizalofop P ethyl) ranged from 0.145 ppm to 1.32 ppm in sunflower seeds.

Magnitude of the Residue   Sunflower Processing Studies A processing study was conducted using sunflowers grown in North Dakota in 1998 ( MRID 44967702). Sunflower seeds were harvested 60 days after a single application of an EC formulation of quizalofop P ethyl at 0.604 lb ai/ A ( 5x the proposed seasonal application rate). The seeds were processed using a simulated commercial procedure into meal and oil and the samples were analyzed using a validated method ( MRID 44967703). The limit of quantitation of the analytical method is 0.05 ppm. Overall recoveries averaged 74% for quizalofop P ethyl and 87% for quizalofop P in meal, and 89% for quizalofop P ethyl and 88% for quizalofop P in oil. Samples were stored frozen 21 to 172 days before extraction.

Average residues of quizalofop P ethyl and quizalofop P ( expressed as quizalofop Pethyl were 2.45 ppm in seeds, 2.87 ppm in meal, and < 0.05 ppm in oil. Therefore, residues of quizalofop P ethyl are not likely to concentrate in meal or in oil.

Magnitude of the Residue   Flax Crop Field Trials Five trials were conducted in 1999, one trial each in Minnesota and South Dakota and three trials in North Dakota ( Report No. SARS 99 10). Each treated plot received two sequential postemergent applications of an EC formulation of quizalofop P ethyl applied at proposed label rates using ground broadcast spray equipment. The applications were made with a 6 to 8 day 4 spray interval. The target application rates were 12.0 fluid ounces of product/ acre/ application ( 0.0806 lb ai/ A) for the first application and 12.0 fluid ounces of product/ acre/ application ( 0.0806 lb ai/ A) for the second application.

Samples of flaxseeds from four of the sites were analyzed for residues of quizalofop Pethyl and quizalofop P expressed as quizalofop P ethyl using a validated analytical method ( Report No. SARS 98 6). The overall recoveries for the method validations averaged 93% + 2.5 for quizalofop P ethyl and 92% + 4.6 for quizalofop P. The limit of quantification ( LOQ) was 0.05 ppm. The results of the analysis of the treated samples from the field sites indicate that residues were less than the LOQ ( 0.05 ppm).

Magnitude of the Residue  Flax Processing Studies A processing study of flax processed commodity ( meal) was conducted using flax grown in Minnesota in 1999 ( Report No. SARS 99 11). The trial consisted of a control plot and two treated plots. Each plot received either a single application of 0.322 lb ai/ A and the other plot received a treatment of 0.806 lb ai/ A, respectively, 2X and 5X the maximum annual use rate permitted on the labeling. The flaxseeds were harvested at normal crop maturity, 74 days after application and processed into flax meal. An untreated control and 5X exaggerated RAC flaxseed samples were analyzed using a validated method. The method was validated on flaxseed as part of the " Magnitude of Quizalofop P Ethyl and Quizalofop P Residues in the Raw Agricultural Commodity, Flaxseeds ( Report No. SARS 98 10) for both analytes at the levels of 0.05 ppm and 5.0 ppm. The overall recoveries for the method validations averaged 93% + 2.5 for quizalofop Pethyl and 92% + 4.6 for quizalofop P in flaxseed. The LOQ for quizalofop P ethyl and quizalofop P was set at 0.05 ppm for flaxseed.

Since there were no residues above the LOQ in the 5X treated sample and 1X raw agricultural commodity samples in the magnitude of residue study ( Report No. SARS 99 10), the samples were not processed into meal.

Magnitude of the Residue   Wheat Crop Field Trials Thirty three field trials using spring and winter wheat varieties were initiated in 2001 in U. S. EPA Regions 2, 4, 5, 6, 7, 8, and 11 and Canadian PMRA Zones 5, 7, 7A, and 14. Forage, hay, grain, and straw samples were collected at normal harvest intervals following one preplant broadcast application made one day prior to planting ( except at three sites where the applications were made on the same day as the planting) with an emulsifiable concentrate ( EC) formulation of quizalofop P ethyl. The formulation was applied by ground equipment at the maximum label use rate of 0.068 lb ai/ A ( 76 g ai/ ha). The residues of quizalofop P ethyl and quizalofop P ( expressed as quizalofop P ethyl) were not detectable in treated samples. The exceptions were for one straw and grain sample, each with one sample with residues at the LOD, and 18 additional samples with residues < LOD. Based on these results, it can be concluded that the uptake of quizalofop P ethyl by wheat or from soil treated with the formulation is negligible. 5 Magnitude of the Residue   Wheat Processing Studies A processing study was conducted using wheat grown in a third plot established in Idaho specifically for processing fractions. This plot received one preplant broadcast application of the quizalofop P ethyl formulation at an exaggerated 5X rate of 0.34 lb ai/ A ( 381 g ai/ ha) ( ± 5%). At this site, grain samples weighing approximately 200 lb were collected from the untreated and 5X rate treated plots for processing by procedures that simulate commercial practices. Samples collected at the processing facility were whole grain, bran, flour, germ, middlings, and shorts. No detectable residues were found in the 5X rate whole grain and processed fractions; therefore the concentration factors for all processed fractions were < 1. Therefore, residues of quizalofop Pethyl are not likely to concentrate in processed wheat products.

Magnitude of the residue   Barley Crop Field Trials Twenty five field trials using spring and fall varieties of barley were initiated in 2001 in U. S. EPA Regions 1, 5, 7, 9, 10, and 11 and Canadian PMRA Zones 5B, 7, and 14. Hay, grain, and straw samples were collected at normal harvest intervals following one preplant broadcast application made one day prior to planting ( except at two sites where the applications were made on the same day as the planting) with an emulsifiable concentrate ( EC) formulation of quizalofop P ethyl. The formulation was applied by ground equipment at the maximum label use rate of 0.068 lb ai/ A ( 76 g ai/ ha). Residues were below the detection limits ( ND) for all samples except for five untreated control samples and six treated samples. With one exception, the residues in samples with detectable residues were less than the LOQ of 0.05 ppm. The one positive untreated control result ( 0.095 ppm) was likely a result of laboratory contamination at the time of sample processing/ grinding.

Magnitude of the Residue in Plants.

The studies submitted include field trials in three regions for succulent beans, six additional sites for dry beans in four regions and five additional sites in three regions for sugar beets.

In conjunction with previously submitted data, an adequate amount of geographically representative crop field trial residue data were presented which show that the proposed tolerances should not be exceeded when quizalofop ethyl is formulated into Assure< Register> and used as directed.

Magnitude of the Residue in Animals.

A ruminant feeding study has been submitted and reviewed by EPA. In summary, three groups of three lactating dairy cows ( plus a control group) were fed 0.1, 0.5, and 5.0 ppm quizalofop ethyl ester ( encapsulated) for 28 consecutive days. Milk was collected daily and a subsample was divided into skim milk and cream. Two cows were sacrificed after 28 days with samples of fat, skeletal muscle, liver, and kidney being collected and analyzed. The remaining cow 6 in each test group was fed a regular diet without encapsulated quizalofop ethyl ester for 7 additional days before sacrifice. Whole milk, skim milk, and cream from the control, and the 0.1 and 0.5 ppm dose groups showed no quizalofop to < 0.02 ppm ( 0.05 ppm in cream). From the 5 ppm dose, quizalofop residues ranged from 0.01 to 0.02 ppm in whole, and when these samples were separated into cream and skim milk, the quizalofop partitioned into the cream with residues plateauing at 0.26 to 0.31 ppm. No quizalofop to < 0.02 ppm was detected in skeletal muscle, and to < 0.05 ppm was detected in any liver or fat sample from any of the three doses. Quizalofop was detected in one kidney sample as 0.05 ppm from the 5 ppm dose.

From the feed items in this petition, all of the feed items in cattle diets can be treated with quizalofop ethyl ester. A theoretical beef cattle diet consisting of canola meal, bean and pea forage, pea hay, and sugar beet tops which none the less maximizes the potential quizalofop exposure of 2.1 ppm. A theoretical dairy cattle diet consisting of pea and bean forage would none the less maximize the potential quizalofop exposure at 2.4 ppm. Substitutions of other feed items and varying their percentages in the diets would give a lower dietary quizalofop burden.

The results of the quizalofop ethyl ester bovine feeding study show that finite residues will actually occur in milk and tissues from the feeding of quizalofop ethyl ester treated RACS or their processed feed items when Assure< Register> II is used as directed. The established quizalofop and quizalofop ethyl ester tolerance in milk, and in fat, meat, and meat by products of cattle, goats, hogs, horse, and sheep are adequate and need not be increased from these additional uses.

A poultry feeding study has been submitted and reviewed. In summary, 3 groups of 20 hens ( plus 1 control group) were dosed with encapsulated quizalofop ethyl ester at 0.1, 0.5, and 5 ppm daily for 28 consecutive days. Eggs were collected daily, and after 28 days 3/ 4 of the hens in each test group were sacrificed, and samples of fat, liver, kidney, breast and thigh muscles were collected and analyzed. Tissues from each test group were pooled prior to analysis. The remaining five hens were fed a regular poultry diet without quizalofop ethyl ester for an additional 7 days before sacrifice. No quizalofop residues were detected in the liver to < 0.05 ppm, and in breast and thigh muscles to < 0.02 ppm for any dose administered. From the 5 ppm dose, one kidney sample showed 0.09 ppm quizalofop, two fat samples were 0.05 and 0.06 ppm quizalofop, and one egg sample was 0.02 ppm quizalofop.

The results of the quizalofop ethyl ester poultry feeding study show that while it is not possible to establish with certainty whether finite residues will actually occur in eggs and tissues from the feeding of quizalofop ethyl ester treated RACS or their processed feed items when Assure< Register> II is used as directed, there is a reasonable expectation for such residues to occur. The established tolerance of quizalofop and quizalofop ethyl ester in eggs, and in fat, meat, and meat by products of poultry are adequate and need not be changed from these additional uses.

B. Toxicological Profile 7 1. Acute toxicity. Several acute toxicology studies were conducted, and the overall results placed technical grade quizalofop ethyl in toxicity Category III. These include the following studies in Category III: acute oral toxicity ( LD50s 1480 and 1670 for female and male rats, respectively) and eye irritation ( mild effects; reversible within 4 days). Dermal toxicity ( LD50 > 5,000 mg/ kg; rabbit), inhalation toxicity ( LC50 > 5.8 mg/ L; rat) and dermal irritation were classified within Category IV. Technical quizalofop ethyl was not a dermal sensitizer.

2. Genotoxicty. Technical quizalofop ethyl was negative in the following genotoxicity tests: bacterial gene mutation assays with E. coli and S. typhimurium; gene mutation assays in Chinese hamster ovary( CHO) cells ; in vitro DNA damage assays with B. subtillis and in rat hepatocytes; and an in vitro chromosomal aberration test in CHO cells.

3. Reproductive and developmental toxicity. A developmental toxicity study in rats administered dosage levels of 0, 30, 100, and 300 mg/ kg/ day. The maternal toxicity no observed effect level ( NOEL) was 30 mg/ kg/ day and a developmental toxicity NOEL was greater than the highest dose tested ( HDT) of 300 mg/ kg/ day. The maternal NOEL was based on reduced food consumption and increased liver weights.

A developmental toxicity study in rabbits administered dosage levels of 0, 7, 20, and 60 mg/ kg/ day with no developmental effects noted at 60 mg/ kg/ day ( HDT). The maternal toxicity NOEL was 20 mg/ kg/ day based on decreases in food consumption and body weight gain at 60/ mg/ kg/ day ( HDT).

A two generation reproduction study in rats fed diets containing 0, 25, 100 or 400 ppm ( or approximately 0, 1.25, 5, and 20 mg/ kg/ day, respectively) with a developmental ( systemic effects) NOEL of 1.25 mg/ kg/ day for F2B weanlings based on increased liver weights and increased incidence of eosinophilic changes in the livers at 5.0 mg/ kg/ day. These liver changes were considered to be physiological or adaptive changes to compound exposure among weanlings. When access to the mother's feed is available, it is a common observation that young rats will begin consuming chow prior to complete weaning at 21 days of age. Consumption could not be quantified; therefore, the maternal consumption was assumed as the NOEL. If normalized on a body weight basis, exposures to the weanling rats were likely higher. The parental NOEL of 5.0 mg/ kg/ day was based on decreased body weight and premating weight gain in males at 20 mg/ kg/ day ( HDT).

4. Subchronic toxicity. A 90 day study was conducted in rats fed diets containing 0, 40, 128, and 1,280 ppm ( or approximately 0, 2, 6.4, and 64 mg/ kg/ day, respectively). The NOEL was 2 mg/ kg/ day, based on increased liver weights at 6.4 mg/ kg.

A 90 day feeding study in mice was conducted with diets that contained 0, 100, 316 or 1,000 ppm ( or approximately 0, 15, 47.4, and 150 mg/ kg/ day, respectively). The NOEL was < 15 mg/ kg/ day, the lowest dose tested ( LDT), based on increased liver weights and reversible 8 histopathological effects in the liver at the LDT.

A 6 month feeding study in dogs was conducted with diets that contained 0, 25, 100, or 400 ppm ( or approximately 0, 0.625, 2.5, and 10 mg/ kg/ day, respectively). The NOEL was 2.5 mg/ kg/ day based on increased blood urea nitrogen at 10 mg/ kg/ day.

A 21 day dermal study was conducted in rabbits at doses of 0, 125, 500, or 2,000 mg/ kg/ day. The NOEL was 2,000 mg/ kg/ day ( HDT).

5. Chronic toxicity. An 18 month carcinogenicity study was conducted in CD 1 mice fed diets containing 0, 2, 10, 80, or 320 ppm ( or approximately 0, 0.3, 1.5, 12, or 48 mg/ kg/ day, respectively). No carcinogenic effects were observed under the conditions of the study at levels up to and including 12 mg/ kg/ day. A marginal increase in the incidence of hepatocellular tumors was observed at 48 mg/ kg/ day, the HDT, which exceeded the maximum tolerated dose ( MTD). ( See the discussion by the EPA Carcinogenicity Peer Review Committee. Toxicology Branch Peer Review Committee: Draft Document on Assure based on November 5, 1986 CPRC Meeting Dated December 9, 1986).

A two year chronic toxicity/ carcinogenicity study was conducted in rats fed diets containing 0, 25, 100, or 400 ppm ( 0, 0.9, 3.7, or 15.5 mg/ kg/ day for males and 0, 1.1, 4.6, or 18.6 mg/ kg/ day for females, respectively). No carcinogenic effects were observed under the conditions of the study at levels up to and including 18.6 g/ kg/ day ( HDT). The systemic NOEL was 0.9 mg/ kg/ day based on altered red cell parameters and slight/ minimal centrilobuler enlargement of the liver at 3.7 mg/ kg/ day.

A one year feeding study was conducted in dogs fed diets containing 0, 25, 100, or 400 ppm ( or approximately 0, 0.625, 2.5, or 10 mg/ kg/ day, respectively). The NOEL was 10 mg/ kg/ day ( HDT).

The Carcinogenicity Peer Review Committee ( CPRC) of HED has evaluated the rat and mouse cancer studies on quizalofop along with other relevant short term toxicity studies, mutagenicity studies, and structure activity relationships. The CPRC concluded, after three meetings and an evaluation by the EPA Science Advisory Panel ( SAP), that the classification should be a Category D ( not classifiable as to human cancer potential). No new cancer studies were required. ( CPRC Report: Peer Review of Assure, February 6, 1987; JA Quest to RJ Taylor. SAP Findings ( Assure) Document signed by Steve Johnson, December 23, 1987).

The first CPRC review tentatively concluded that quizalofop should be classified as a Category B2 ( probable human carcinogen). That classification was based on liver tumors in female rats, ovarian tumors in female mice, and liver tumors in male mice. This classification was downgraded to a Category C ( possible human carcinogen) at a second CPRC review. The change in classification resulted from a reexamination of the liver tumors in female rats and ovarian tumors in female mice. The first peer review had found a statistically significant positive trend for liver carcinomas in female rats. Subsequent to this conclusion, a tumor data reevaluation showed a reduced number of carcinomas. Although there remained a statistically significant positive trend for carcinomas in the study, the CPRC concluded that the carcinomas were not biologically significant given the few 9 carcinomas identified ( one at the mid dose and two at the high dose). Noting that this level of carcinomas was within historical levels, the CPRC concluded that administration of quizalofop did not appear to be associated with the liver carcinomas.

The CPRC had first attached importance to the fact that the ovarian tumors in female mice, were statistically significant at the high dose compared to historical control values, and statistically significant when compared to concurrent controls. However, review of further historical control data showed that the level of ovarian tumors in the quizalofop study was similar to the background rate in several other studies. Given this information and the fact that the quizalofop study showed no hyperplasia of the ovary, no signs of endocrine activity related to ovarian function, and no dose response relationship, the CPRC concluded that the ovarian tumors were probably not compoundrelated

The findings of the second CPRC review were presented to the SAP. The SAP concurred with the CPRC conclusion that the liver tumors in female rats and the ovary tumors in female mice showed no evidence of carcinogenicity. However, the SAP disagreed with CPRC's classification of quizalofop as a Category C based on the liver tumors in male mice. The SAP concluded that the mouse liver tumors did not support such a classification because the tumors occurred at a dose above the MTD and because they were not statistically significant if they had a " p" value of less than 0.05. The SAP believed that such greater statistical rigor was appropriate for variable tumor endpoints such as male mouse liver tumors.

Following the SAP review, the CPRC changed the classification for quizalofop to Category D. The Category D classification is based on an approximate doubling in the incidence of male mice liver tumors between controls and the high dose. This finding was not considered strong enough to warrant the finding of a Category C ( possible human carcinogen), since the increase was of marginal statistical significance, occurred at a high dose that exceeded the predicted MTD, and occurred in a study in which the concurrent control for liver tumors was somewhat low compared to the historical controls; while the high dose group was at the upper end of previous historical control groups.

EPA has found the evidence on the carcinogenicity of quizalofop p ethyl ester in animals to be equivocal and, therefore, concludes that quizalofop p ethyl ester does not induce cancer in animals.

Important to this conclusion was the following evidence:

( 1) The only statistically significant tumor response that appears compound related was seen at a single dose in a single sex in a single species;

( 2) the response was only marginally statistically significant;

( 3) the response was only significant when benign and malignant tumors were combined;

( 4) the tumors were in the male mouse liver;

( 5) the tumors were within historical controls; and 10 ( 6) the mutagenicity studies were negative.

In some circumstances, a finding of animal carcinogenicity would be made despite any one, or even several, of the six factors noted. However, the combination of all of these factors casts sufficient doubt on the reproducibility of the response in the high dose male mouse and therefore, EPA concluded that the evidence on carcinogenicity is equivocal.

6. Animal metabolism. Animal metabolism studies have been conducted with laying hens and lactating goats using 14C phenyl and 14C quinoxaline quizalofop ethyl ester. These studies were reviewed and accepted by EPA. EPA concluded that the metabolism of quizalofop P ethyl is adequately understood.

The primary metabolic pathway in ruminants is via hydrolysis of the ethyl ester to form the quizalofop P methyl ester. In poultry, the primary metabolic pathway is also the hydrolysis of the ethyl ester to form the quizalofop P acid, followed by the methyl esterification to form the quizalofop methyl ester as a minor pathway of metabolism. The residues of concern are quizalofop ethyl, quizalofop methyl, and quizalofop, all expressed as quizalofop ethyl. There is no evidence that the metabolites of quizalofop ethyl, as identified in animal metabolism studies, have any toxicological significance.

7. Metabolite toxicology. There is no evidence that the metabolites of quizalofop ethyl as identified as either the plant or animal metabolism studies are of any toxicological significance.

8. Endocrine disruption. No special studies investigating potential estrogenic or other endocrine effects of quizalofop P ethyl have been conducted. However, the standard battery of required toxicology studies has been completed. These include an evaluation of the potential effects on reproduction and development, and an evaluation of the pathology of the endocrine organs following repeated or long term exposure to doses that far exceed likely human exposures. Based on these studies there is no evidence to suggest that quizalofop P ethyl has an adverse effect on the endocrine system.

C. Aggregate Exposure 11 ( i) 1. Dietary exposure. Dietary Exposure. Acute and chronic dietary risk assessments were conducted for quizalofop P ethyl using the Dietary Exposure Evaluation Model ( DEEM) and the USDA Continuing Survey of Food Intake by Individuals ( CSFII, for 1994 to 1996, as contained in DEEM). For these assessments it was assumed that 100% of the crop was treated with quizalofop P ethyl. Established or proposed tolerances were used to estimate dietary exposure from the consumption of cereal grains, dairy products, dried and succulent shelled peas and beans, edible pod legume vegetables, leaves of root and tuber vegetables, legume vegetables, meat, poultry, canola, carob, cottonseed, peppermint, pineapples, spearmint, sugarcane/ molasses, sunflowers, flax, wheat and barley. Given flax's tolerance level of 0.05 ppm and its scarcity in the human diet, quizalofop P ethyl on flax does not contribute to the acute dietary and chronic exposure.

A. Acute Dietary Exposure. The predicted acute exposure at the 95 th percentile in the U. S. population for all commodities was 0.001160 mg/ kg bw/ d. The population subgroup with the highest predicted level of acute exposure was the non nursing infants (< 1 year) subgroup ( 0.003315 mg/ kg bw/ d). Based on an acute NOEL of 20 mg/ kg bw/ d and a 100 fold safety factor, the acute reference dose ( aRfD) is 0.2 mg/ kg bw/ d. No additional uncertainty factors were assigned for susceptible populations. For the U. S. population, the predicted exposure is equivalent to 0.58 % of the aRfD. Because the predicted exposures, expressed as percentages of the aRfD, are well below 100%, there is reasonable certainty that no acute effects would result from dietary exposure to quizalofop P ethyl.

B. Chronic Dietary Exposure. The predicted chronic exposure in the U. S. population for all commodities was 0.000424 mg/ kg bw/ d. The population with the highest predicted level of chronic exposure ( 0.001184 mg/ kg bw/ d) was the non nursing infants (< 1 year) subgroup. Based on a chronic NOEL of 0.9 mg/ kg bw/ d and a 100 fold safety factor, the chronic reference dose ( cRfD) would be 0.009 mg/ kg bw/ d. No additional uncertainty factors were assigned for susceptible populations. For the population subgroup with the highest level of exposure ( non nursing infants (< 1 year), the exposure would be equivalent to 13.2% of the cRfD. Because the predicted exposures, expressed as percentages of the cRfD, are well below 100%, there is reasonable certainty that no chronic effects would result from dietary exposure to quizalofop P ethyl.

i. Food. Not applicable.

ii. Drinking water. There is no established maximum concentration level for quizalofop Pethyl in water. Tier 1 drinking water assessments were conducted for ground and surface water to determine the risk of exposure to quizalofop P ethyl. The method used was a comparison of the calculated Drinking Water Level of Comparison ( DWLOC) value to the Drinking Water Estimated Concentration ( DWEC) value. The results show that all of the 12 DWEC values are lower than the DWLOC values. Therefore, exposure to quizalofop Pethyl in drinking water is not a concern..

2. Non dietary exposure. Quizalofop P ethyl is not registered for any use that could result in non occupational, non dietary exposure to the general population.

D. Cumulative Effects ( b) There is no evidence to indicate or suggest that quizalofop P ethyl has any toxic effects on mammals that would be cumulative with those of any other chemicals.

E. Safety Determination A dietary exposure assessment for the herbicide quizalofop p ethyl was conducted using Novigen's Dietary Exposure Evaluation Model ( DEEMTM ) Version 7.76. Dietary exposure to quizalofop p ethyl was based upon the following crop group uses: dairy products, dried shelled pea and bean ( including soybeans), edible pod legume vegetables, leaves of root and tuber vegetables, legume vegetables, meat, poultry, succulent shelled peas and beans; and the following crop uses: canola, cottonseed, peppermint, pineapples, spearmint, sugarcane/ molasses, sunflowers, flax, wheat and barley.

1. U. S. population. For the overall U. S. population, the predicted acute exposure would be 0.001160 mg/ kg bw/ day, or at the 95th percentile. Based on an acute NOEL of 20 mg/ kg bw/ d and a 100 fold uncertainty factor, the acute reference dose ( aRfD) would be 0.2 mg/ kg bw/ d. For the U. S. population the predicted acute exposure is equivalent to 0.58% or less of the estimated aRfD. The predicted chronic exposure for the overall U. S. population subgroup was 0.000424 mg/ kg bw/ day. Based on a chronic NOEL of 0.9 mg/ kg bw/ d and a 100 fold safety factor, the chronic reference dose ( cRfD) would be 0.009 mg/ kg bw/ d. For the U. S. population, the predicted exposure is equivalent to 4.7% of the cRfD. Because the predicted exposures, expressed as percentages of the cRfD, are well below 100%, there is reasonable certainty that no acute or chronic effects would result from dietary exposure to quizalofop p ethyl.

2. Infants and children. The population subgroup with the highest predicted level of acute exposure was the non nursing infants (< 1 year) subgroup with an exposure of 0.003315 mg/ kg bw/ day ( 95th percentile). Based on an acute NOEL of 20 mg/ kg bw/ d and a 100 fold safety factor, the acute reference dose ( aRfD) would be 0.2 mg/ kg bw/ d. The acute exposure for nonnursing infants (< 1 year) would be equivalent to 1.66% of the aRfD. The population subgroup with the highest predicted level of chronic exposure was the non nursing infants (< 1 year) subgroup with an exposure of 0.001184 mg/ kg bw/ day. Based on a chronic NOEL of 0.9 mg/ kg bw/ d and a 100 fold safety factor, the chronic reference dose ( cRfD) would be 0.009 mg/ kg bw/ d. The chronic exposure for non nursing infants (< 1 year) would be equivalent to 13.2% of the cRfD. Because the predicted exposures, expressed as percentages of the cRfD, are well below 100%, there is reasonable certainty that no acute or chronic effects would result from dietary exposure to quizalofop p ethyl. 13 F. International Tolerances Harmonization of Tolerances: There are no Mexican, Canadian or Codex MRL's/ tolerances; therefore, compatibility is not an issue.


[Federal Register Volume 83, Number 130 (Friday, July 6, 2018)]
[Proposed Rules]
[Pages 31493-31496]
[FR Doc No: 2018-13925]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0553; Product Identifier 2017-NM-138-AD]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc., Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt an airworthiness directive (AD) for
certain Bombardier, Inc., Model DHC-8-102, -103, and -106 airplanes,
Model DHC-8-200 series airplanes, and Model DHC-8-300 series airplanes.
This proposed AD was prompted by reports of arcing and smoke emanating
from the windshield, caused by loose or damaged windshield heater
terminal lugs. This proposed AD would require revising the maintenance
or inspection program to incorporate maintenance review board (MRB)
tasks for general visual inspections of the windshield moisture seal.
This proposed AD would also require re-torqueing the windshield heater
terminal lugs, applying a coating to the windshield heater screw heads,
doing a chemical cleaning of the wiring and components, doing a visual
inspection of the wiring and components, doing an operational test of
the pilot's and co-pilot's windshield heating system, and repair if
necessary.

We are proposing this AD to address the unsafe condition on these
products.

DATES: We must receive comments on this proposed AD by August 20, 2018.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact
Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt Boulevard,
Toronto, Ontario M3K 1Y5, Canada; telephone<PHONE_NUMBER>; fax 416-375-
4539; email [email protected]; internet http://www.bombardier.com. You may view this service information at the FAA,
Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call 206-
231-3195.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0553; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this NPRM, 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. Comments
will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Assata Dessaline, Aerospace Engineer,
Avionics and Administrative Services Section, FAA, New York ACO Branch,
1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-
7301; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2018-0553;
Product Identifier 2017-NM-138-AD'' at the beginning of your comments.
We specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this NPRM. We will consider all
comments received by the closing date and may amend this NPRM based on
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 NPRM.

Discussion

    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian AD CF-2017-25, dated July 31,
2017 (referred to after this as the Mandatory Continuing Airworthiness
Information, or ``the MCAI''), to correct an unsafe condition for
certain Bombardier, Inc., Model DHC-8-102, -103, and -106 airplanes,
Model DHC-8-200 series airplanes, and Model DHC-8-300 series airplanes.
The MCAI states:

    There have been several reports of arcing and smoke emanating
from the windshields. Investigation of these incidents revealed that
de-icing fluid and water could enter between the windshields and
side window posts, leading to possible damage of the windshield
heater terminal lugs creating arcing and smoke. In addition,
investigation also revealed that the windshield heater terminal lugs
tend to loosen over time. Loose terminal lugs could also have a
similar effect of arcing and smoke. Both events could lead to
burning of the lugs and, due to the excessive heat, cracking of the
windshields. If not corrected, these conditions could cause a loss
of cabin pressure resulting in an emergency descent.

    Required actions include revising the maintenance or inspection
program, as applicable, to incorporate MRB tasks for general visual
inspections of the windshield moisture seal (for signs of cracking,
erosion, wear, or other damage), re-torqueing the windshield heater
terminal lugs, applying sealant to the windshield heater screw heads,
doing a chemical cleaning of the wiring and components, doing a general
visual inspection of the wiring and components for signs of cracking,
erosion, wear, or other damage, doing an operational test of the
pilot's and co-pilot's windshield heating system, and repair if
necessary.
    You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0553.

Related Service Information Under 1 CFR Part 51

    Bombardier has issued Service Bulletin 8-30-41, Revision A, dated
March 24, 2017. This service information describes procedures for re-
torqueing the windshield heater terminal lugs and applying Humisel
coating to the screw heads of the windshield heater, doing a chemical
cleaning and general visual inspection of the wiring and components,
and doing an operational test of the windshield heating system.
    Bombardier has also issued the following service information, which
describes airworthiness limitation tasks for a general visual
inspection of the windshield moisture seal. These documents are
distinct since they apply to different airplane models.
     de Havilland Dash 8 Series 100 Maintenance Task Card, Task
Number 5610/01, ``General Visual Inspection of the Windshield Moisture
Seal,'' dated August 5, 2017.
     de Havilland Dash 8 Series 200 Maintenance Task Card, Task
Number 5610/01, ``General Visual Inspection of the Windshield Moisture
Seal,'' dated August 5, 2017.
     de Havilland Dash 8 Series 300 Maintenance Task Card, Task
Number 5610/01, ``General Visual Inspection of the Windshield Moisture
Seal,'' dated March 15, 2017.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

FAA's Determination and Requirements of This Proposed 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 proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Differences Between This Proposed AD and the MCAI or Service
Information

    The MCAI calls for revising the maintenance or inspection program,
as applicable, by incorporating certain temporary revisions (TRs) into
the Program Support Manual (PSM). This proposed AD instead calls for
incorporating certain task cards into the

PSM. We have determined that these task cards address the unsafe
condition in the same manner that the TRs would.

Costs of Compliance

    We estimate that this proposed AD affects 63 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                           Labor cost                               Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
3 work-hours x $85 per hour = $255..............................              $0            $255         $16,065
----------------------------------------------------------------------------------------------------------------

    We have also determined that revising the maintenance or inspection
program takes an average of 90 work-hours per operator, although we
recognize that this number may vary from operator to operator. In the
past, we have estimated that this action takes 1 work-hour per
airplane. Since operators incorporate maintenance or inspection program
changes for their affected fleet(s), we have determined that a per-
operator estimate is more accurate than a per-airplane estimate.
Therefore, we estimate the total cost per operator to be $7,650 (90
work-hours x $85 per work-hour).
    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in 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.
    This proposed AD is issued in accordance with authority delegated
by the Executive Director, Aircraft Certification Service, as
authorized by FAA Order 8000.51C. In accordance with that order,
issuance of ADs is normally a function of the Compliance and
Airworthiness Division, but during this transition period, the
Executive Director has delegated the authority to issue ADs applicable
to transport category airplanes to the Director of the System Oversight
Division.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 proposed
regulation:
    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);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

Bombardier, Inc.: Docket No. FAA-2018-0553; Product Identifier 2017-
NM-138-AD.

(a) Comments Due Date

    We must receive comments by August 20, 2018.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Bombardier, Inc., Model DHC-8-102, -103, -
106, -201, -202, -301, -311, and -315 airplanes, certificated in any
category, serial numbers 003 through 672 inclusive.

(d) Subject

    Air Transport Association (ATA) of America Code 30, Ice and rain
protection.

(e) Reason

    This AD was prompted by reports of arcing and smoke emanating
from the windshield, caused by loose or damaged windshield heater
terminal lugs. We are issuing this AD to address loose terminal lugs
and terminal lugs damaged due to fluid ingress between the
windshields and side window posts, which could lead to burning of
the lugs and cracking of the windshields, and could ultimately cause
a loss of cabin pressure, resulting in an emergency descent.

(f) Compliance

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

(g) Maintenance or Inspection Program Revision

    Within 30 days after the effective date of this AD, revise the
maintenance or inspection program, as applicable, to incorporate the
applicable task cards identified in paragraphs (g)(1), (g)(2), and
(g)(3) of this AD into the applicable Program Support Manual (PSM)
as identified in table 1 to paragraph (g) of this AD. The initial
compliance time for the tasks are within 1,600 flight hours or 12
months, whichever occurs first after the effective date of this AD.
    (1) de Havilland Dash 8 Series 100 Maintenance Task Card, Task
Number 5610/01, ``General Visual Inspection of the Windshield
Moisture Seal,'' dated August 5, 2017.
    (2) de Havilland Dash 8 Series 200 Maintenance Task Card, Task
Number 5610/01, ``General Visual Inspection of the Windshield
Moisture Seal,'' dated August 5, 2017.
    (3) de Havilland Dash 8 Series 300 Maintenance Task Card, Task
Number 5610/01, ``General Visual Inspection of the Windshield
Moisture Seal,'' dated March 15, 2017.

[GRAPHIC] [TIFF OMITTED] TP06JY18.005

(h) No Alternative Actions or Intervals

    After the maintenance or inspection program has been revised as
required by paragraph (g) of this AD, no alternative actions (e.g.,
inspections) or intervals may be used unless the actions or
intervals are approved as an alternative method of compliance (AMOC)
in accordance with the procedures specified in paragraph (k)(1) of
this AD.

(i) Cleaning, Inspection, Re-Torqueing, Sealant Application, and
Operational Test

    Within 8,000 flight hours or 60 months, whichever occurs first
after the effective date of this AD: Perform a chemical cleaning of
the wiring and components, do a general visual inspection of the
wiring and components for signs of cracking, erosion, wear, or other
damage, re-torque the windshield heater terminal lugs, apply
Humiseal coating to the screw heads of the windshield heater, and do
an operational test of the pilot's and co-pilot's windshield heating
system, in accordance with the Accomplishment Instructions of
Bombardier Service Bulletin 8-30-41, Revision A, dated March 24,
2017. If the operational test fails, before further flight, do
corrective actions, repeat the test, and do applicable corrective
actions until the operational test is passed. If any cracking,
erosion, wear, or other damage is found, before further flight,
repair using a method approved by the Manager, New York ACO Branch,
FAA; or Transport Canada Civil Aviation (TCCA); or Bombardier,
Inc.'s TCCA Design Approval Organization (DAO). If approved by the
DAO, the approval must include the DAO-authorized signature.

(j) Credit for Previous Actions

    This paragraph provides credit for actions required by paragraph
(i) of this AD, if those actions were performed before the effective
date of this AD using Bombardier Service Bulletin 8-30-41, dated
March 31, 2016.

(k) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York ACO Branch, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your request to your principal
inspector or local Flight Standards District Office, as appropriate.
If sending information directly to the manager of the certification
office, send it to ATTN: Program Manager, Continuing Operational
Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Before
using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, New York ACO
Branch, FAA; or TCCA; or Bombardier, Inc,'s TCCA DAO. If approved by
the DAO, the approval must include the DAO-authorized signature.

(l) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) Canadian AD CF-2017-25, dated July 31, 2017, for related
information. This MCAI may be found in the AD docket on the internet
at http://www.regulations.gov by searching for and locating Docket
No. FAA-2018-0553.
    (2) For more information about this AD, contact Assata
Dessaline, Aerospace Engineer, Avionics and Administrative Services
Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
    (3) For service information identified in this AD, contact
Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt
Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>; email [email protected]; internet
http://www.bombardier.com. You may view this service information at
the FAA, Transport Standards Branch, 2200 South 216th St., Des
Moines, WA. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.

    Issued in Des Moines, Washington, on June 14, 2018.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2018-13925 Filed 7-5-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 82 (Friday, April 28, 2023)]
[Rules and Regulations]
[Pages 26228-26230]
[FR Doc No: 2023-09120]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2023-0258]
RIN 1625-AA00

Safety Zone; Port of Los Angeles and Port of Long Beach, San
Pedro Bay, CA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary moving safety zone
around the M/V ZHEN HUA 26 while it transits from the Port of Long
Beach, CA, from Long Beach Container Terminal (LBCT), LB Berth E22, to
inner anchorage, and then to Fenix Marine Services (FMS), LA Berth 302.
This safety zone is necessary to protect personnel, vessels, and the
marine environment from potential hazards associated with oversized
cargo of ship-to-shore gantry cranes which extend more than 200 feet
out from the transiting vessel. Entry of persons or vessels into this
safety zone is prohibited unless specifically authorized by the Captain
of the Port (COTP) Los Angeles--Long Beach, or their designated
representative. The Coast Guard recently issued a safety zone for the
transit of the M/V ZHEN HUA 26, but additional time is needed to
complete the cargo delivery.

DATES: This rule is effective April 26, 2023, though May 2, 2023.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2023-0258 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or LCDR Maria Wiener, Waterways Management, U.S. Coast Guard
Sector Los Angeles--Long Beach; telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because The COTP was notified of the
impending arrival of the M/V ZHEN HUA 26 less than 30 days in advance
and immediate action is needed to respond to the potential safety
hazards associated with the transfer of large gantry cranes within the
Ports of Los Angeles and Long Beach. The vessel recently updated their
timeline and timeframe for the crane delivery to FMS after we issued
the first safety zone. This safety zone needs to be extended to protect
personnel, vessels, and the marine environment from potential hazards
associated with oversized cargo of ship-to-shore gantry cranes, which
will extend more than

200 feet out from the transiting vessel. It is impracticable to publish
an NPRM because we must establish this safety zone by April 26, 2023.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be contrary to the public interest because immediate
action is needed to ensure the safety of persons, vessels, and the
marine environment in the vicinity of the M/V ZHEN HUA 26 while
conducting oversized cargo transfer operations at LBCT, LB Berth E22,
to inner anchorage, and FMS, LA Berth 302, within the Port of Los
Angeles--Long Beach, CA.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 and 70011(b)(3). The COTP Los Angeles--Long Beach has determined
that potential hazards associated with the movement of large-scale
gantry crane transfer operations will be a safety concern for anyone
within a 500-foot radius of the M/V ZHEN HUA 26 during its transit from
LBCT, LB Berth E22, while at inner anchorage, and during the vessel's
transit from inner anchorage to FMS, LA Berth 302. This hazard will
exist while the vessel is within the Los Angeles--Long Beach port
complex and the waters inside the Federal breakwaters bounding San
Pedro Bay or on the waters within three nautical miles seaward of the
Federal breakwaters, respectively.

IV. Discussion of the Rule

    This rule establishes a safety zone from April 26, 2023, through
May 2, 2023, during the transit of the M/V ZHEN HUA 26 and while the
vessel is at inner anchorage within the Los Angeles--Long Beach port
complex. While the M/V ZHEN HUA 26 is within the waters inside the
Federal breakwaters bounding San Pedro Bay or on the waters within
three nautical miles seaward of the Federal breakwaters, respectively,
the safety zone will encompass the navigable waters around and under
the vessel, form surface to bottom, within a circle formed by
connecting all points 500-feet out from the vessel. The safety zone is
needed to protect personnel, mariners, and vessels from hazards
associated with ship-to shore gantry crane arms which will extend more
than 200 feet out from the transiting vessel.
    No vessel or person will be permitted to enter the safety zone
without obtaining permission from the COTP or a designated
representative. Sector Los Angeles--Long Beach may be contacted on VHF-
FM Channel 16 or<PHONE_NUMBER>. The marine public will be notified of
the safety zone via Broadcast Notice to Mariners.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

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 rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB).
    This regulatory action determination is based on the size,
location, duration, and time-of-year of the safety zone. This rule
impacts an area of 500-feet surrounding a cargo vessel while at LBCT,
LB Berth E22, and FMS, LA Berth 302, during the months of April and May
2023. This safety zone impacts a 500-foot-radius area of the Port of
Los Angeles--Long Beach and the waters inside the Federal breakwaters
bounding San Pedro Bay or on the waters within three nautical miles
seaward of the Federal breakwaters, respectively for a limited
duration. While the safety zone encompasses a seven-day period to
account for uncertain transit delays of the M/V ZHEN HUA 26, the safety
zone will only be enforced for the duration of the vessel's transit
from LBCT, LB Berth E22, to inner anchorage, while at inner anchorage,
and transit to FMS, LA Berth 302, and that period will be announced via
Broadcast Notice to Mariners. Vessel traffic will be able to safely
transit around this safety zone, which will impact a small, designated
area of the San Pedro Bay, Long Beach and Los Angeles, CA.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 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 rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A. above, this rule will not have a significant economic impact on
any vessel owner or operator.
    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 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
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a 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 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 rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments,

because it does 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.

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 rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have 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 rule involves This
rule involves a safety zone encompassing an area extending 500-feet out
from a cargo vessel in vicinity of Long Beach Container Terminal and
Fenix Marine Services and will last only while transfer operations are
ongoing. It is categorically excluded from further review under
paragraph L60 of Appendix A, Table 1 of DHS Instruction Manual 023-01-
001-01, Rev. 1. A Record of Environmental Consideration supporting this
determination is available in the docket. For instructions on locating
the docket, see the ADDRESSES section of this preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places, or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-
1, 6.04-6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.3.

0
2. Add Sec.  165.T11-123 to read as follows:

Sec.  165.T11-123  Safety Zone; Port of Los Angeles and Port of Long
Beach, San Pedro Bay, CA.

    (a) Location. The following area is a safety zone: all navigable
waters of the Port of Los Angeles and the Port of Long Beach, from
surface to bottom, within a circle formed by connecting all points 500-
feet out from the vessel, M/V ZHEN HUA 26, during the vessel's transit
inside the Federal breakwaters bounding San Pedro Bay or on the waters
within three nautical miles seaward of the Federal breakwaters,
respectively.
    (b) Definitions. As used in this section, designated representative
means a Coast Guard coxswain, petty officer, or other officer operating
a Coast Guard vessel designated by or assisting the Captain of the Port
Los Angeles--Long Beach (COTP) in the enforcement of the safety zone.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) To seek permission to enter, contact the COTP or the COTP's
representative by hailing Coast Guard Sector Los Angeles--Long Beach on
VHF-FM Channel 16 or calling at<PHONE_NUMBER>. Those in the safety
zone must comply with all lawful orders or directions given to them by
the COTP or the COTP's designated representative.
    (d) Enforcement period. This temporary safety zone will be enforced
from April 26, 2023, through May 2, 2023, during the M/V ZHEN HUA 26's
transit between Long Beach Container Terminal, LB Berth E22, to inner
anchorage, while at inner anchorage and then to Fenix Marine Services,
LA Berth 302, or as announced via Broadcast Notice to Mariners.
    (e) Informational broadcasts. The COTP or a designated
representative will inform the public of the enforcement date and times
for this safety zone via Local Notices to Mariners.

    Dated: April 24, 2023.
R.D. Manning,
Captain, U.S. Coast Guard, Captain of the Port Sector Los Angeles--Long
Beach.
[FR Doc. 2023-09120 Filed 4-26-23; 4:15 pm]
BILLING CODE 9110-04-P