UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM PC Code: 121001 DPBarcode: D312559 SUBJECT: Sethoxydim Drinking Water Assessment ( Tier 1) for Reregistration Eligibility Decision FROM: William P. Eckel, Ph. D. Environmental Risk Branch II Environmental Fate and Effects Division ( 7507C)

TO: Amaris Johnson Special Review and Reregistration Division ( 750C)

THRU: Tom Bailey, Branch Chief Environmental Risk Branch II / EFED ( 7507C)

DATE: February 7, 2005 This memorandum provides EFED's drinking water assessment for the sethoxydim reregistration eligibility decision ( RED). The estimated drinking water concentrations ( EDWCs) for total sethoxydim residues are 1.5 ppb for ground water, and 130 ppb ( acute) and 16 ppb ( chronic) for surface water.

Usage Assessment Sethoxydim is registered for use on a large number of crops. 40CFR180.412 ( revised as of 7/ 1/ 2004) lists tolerances for sethoxydim in 99 commodities. The BEAD Usage Report for sethoxydim ( 7/ 30/ 2004) gives estimates for usage on 86 different crops. The ten crops with the highest estimated usage are soybeans ( CBI material deleted here by request of the registrant), sunflowers ( CBI material deleted here by request of the registrant), alfalfa ( CBI material deleted here by request of the registrant), dry peas/ beans ( CBI material deleted here by request of the registrant), sugarbeets ( CBI material deleted here by request of the registrant), peanuts ( CBI material deleted here by request of the registrant), corn ( CBI material deleted here by request of the registrant), oranges ( CBI material deleted here by request of the registrant), potatoes ( CBI material deleted here by request of the registrant), and cotton ( CBI material deleted here by request of the registrant). The U. S. Geological Survey has estimated 1997 usage, as depicted in Map 1. The USGS estimates of annual usage are higher for soybeans, alfalfa, cotton, sugarbeets, and peanuts. This may represent a decrease in overall annual usage. 2 Map 1: 1997 Usage of Sethoxydim as Estimated by U. S. Geological Survey ( http:// ca. water. usgs. gov/ cgi bin/ pnsp/ pesticide_ use_ maps_ 1997. pl? map= W1910). 3 Use Rate and Frequency The maximum seasonal use rate in the Use Closure Memorandum ( 8/ 24/ 2004) is 1.875 lb active ingredient ( a. i.)/ acre per year ( 4 applications of 2.5 pints each formulated product containing 1.5 lb a. i. per gallon). The maximum single use rate is 0.47 lb a. i./ acre. For purposes of this assessment, four applications of 0.47 lb a. i./ acre spaced at 14 days, will be modeled ( LUIS report 1/ 14/ 2004). Fourteen days is the shortest application interval given in the LUIS report, however, intervals are not specified for many uses.

Environmental Fate Assessment In terrestrial environments, photodegradation, aerobic metabolism, and acid catalyzed hydrolysis appear to be the primary routes of dissipation for Sethoxydim and for Sethoxydim total residues. The calculated soil photolytic half life for Sethoxydim is 1 hour and 20 hours for Sethoxydim residues ( parent + transformation products), indicating rapid transformation of Sethoxydim and its residues after application. Other potential routes of dissipation are microbialmediated degradation and surface water runoff. Under aerobic conditions, Sethoxydim degrades in less than 1 day, while Sethoxydim total residues have half lives which range from 7 to 30 days.

In aquatic environments, the major route of dissipation for total Sethoxydim residues is aqueous photolysis ( t 1/ 2= 19.8 days), followed by microbially mediated degradation. In aerobic aqueous studies, half lives are on the order of about one month ( 32.9 38.1 days).

Laboratory studies show that Sethoxydim is a highly soluble compound ( 4700 mg/ L in water) and that it hydrolyzes at moderately rapid rates at low pH, but is more stable at high pH. The calculated half lives are 8.7, 155, and 284 days in pH 5, 7, and 9 solutions, respectively. The major observed hydrolysis transformation product is M2 S or 6( 2( ethylthio) propyl) 4 oxo 2 propyl 4,5,6,7 tetrahydrobenzoxazole. In contrast, evaluation of the data of Sethoxydim total residues shows that they remain stable at all three pH tested.

Sethoxydim and Sethoxydim total residues degrade photolytically in both water and soil. In pH buffered water, the calculated half life of Sethoxydim is 5.23 days, and the major transformation product is M1 S or 2( 1 aminobutylidene) 5( 2( ethylthio) propyl) cyclohex 1,3 dione. In sandy loam soil irradiated with a xenon light source, the half life of Sethoxydim is approximately 1 hour, and the major transformation product is M SO or 2( 1 ethoxyiminobutyl) 5( 2( ethylsulfinyl) propyl) 3 hydroxycyclohex 2 enone. Sethoxydim total residues photodegrade slower than parent Sethoxydim in soil and water. Using a linear regression analysis, EFED calculated a half life of 19.8 days for the photolysis in water of Sethoxydim total residues and a half life of 20 hours in soil.

Under aerobic conditions, parent Sethoxydim transformed with short half lives (

1 day) both in soil and aquatic environments. It degraded with a half life of less than one day in sandy loam and sandy clay loam soils. The major transformation product at 2 months was M SO, and after 12 months the major product was CO 2. Using an aerobic clay loam soil: water and an aerobic clay soil: water systems, it was determined that, under aerobic aquatic conditions, Sethoxydim transformed 4 with a half life of

1 day. After 28 days, the major transformation products were CO 2, M SO, M2 S, and M SO 2 or 2( 1 ethoxyiminobutyl) 5( 2( ethylsulfonyl) propyl) 3 hydroxycyclohex 2 enone. In contrast to parent Sethoxydim, Sethoxydim total residues were more persistent. The observed halflife was 1 month for Sethoxydim total residues in the aerobic sandy loam study, and 7 days in the aerobic sandy clay loam study. In an aerobic clay loam soil: water system, the calculated half life for Sethoxydim total residues was 38.1 days, while in an aerobic clay soil: water system the half life was 32.9 days.

Based on batch equilibrium experiments, Sethoxydim and its transformation products, M2 SO 2, M SO, M SO 2, and M2 SO, were determined to be mobile to very mobile in sterile ( autoclaved) sand, sandy loam, sandy clay loam, silt loam, and clay loam soils. Freundlich K ads values were < 1.00 for Sethoxydim and its transformation products M SO and M SO 2. The Freundlich K ads values for M2 SO and M2 SO 2 ranged from 0.06 to 9.12.

Because of its low vapor pressure ( 1.6x10 7 mm Hg) and Henry's Law Constant ( 1.47x1011 atm m3/ mol), Sethoxydim is not expected to be highly volatile.

Residues of Interest in Drinking Water The Metabolism Assessment and Review Committee of the Health Effects Division met of May 14, 1998 to consider which residues of sethoxydim to include in the drinking water assessment. The memorandum of this meeting ( 5/ 27/ 1998) states that all degradates are to be included.

Ground Water The following input parameters were used for the SCIGROW model, version 2.3, to estimate drinking water concentrations from ground water sources. Four applications of 0.47 lb a. i./ acre; Organic Carbon partition coefficient ( Koc) of 2.72 mL/ g ( MRID 41475212) and an average aerobic soil metabolism half life of 18.5 days for total residues ( MRID 41475210).

The estimated drinking water concentration is 1.5 ppb for ground water sources.

Surface Water For Tier 1 drinking water assessments, EFED uses the surface water model FIRST, or FQPA Index Reservoir Screening Tool. FIRST simulates a PRZM EXAMS run for a small drinking water reservoir in Shipman City, Illinois. The reservoir is 13 acres in area, 9 feet deep, and has a watershed area of 427 acres, and was selected because it had Safe Drinking Water Act compliance problems with herbicides.

The following data were used as inputs to the FIRST model for aerial application of sethoxydim at the maximum labeled use rate and minimum application intervals. 5 Model Input Variable Input Value Comments Application Rate ( maximum) 0.47 lb a. i./ acre ( 2.5 pints) LUIS report 1/ 14/ 2004 Maximum Number of Applications 4 ( 10 pints max. per season) LUIS report 1/ 14/ 2004 Application Interval 14 days ( minimum) LUIS report 1/ 14/ 2004 Organic Carbon Partition Coefficient ( Kd) 0.03 ( lowest non sand Kd) Source: MRID 41475212 Aerobic Soil Metabolism Half life 54 days ( Upper 90th % ile on two values for total residues) Source: MRID 41475210 Pesticide wetted in? No Source: label 7969 58, 9/ 24/ 99 Spray Drift 16 % Standard for Aerial Application Solubility ( mg/ L) 4700 Source: EFED one liner database Aerobic Aquatic Half life 44 days ( Upper 90th % ile on two values for total residues) Source: MRID 42165604 Photolysis Half life 19.8 days ( total residues) Source: MRID 41475208 Percent Cropped Area 87% default The FIRST model gave the following results for untreated drinking water concentrations from surface water sources, to two significant figures.

Chemical( s) modeled Peak day ( acute) Annual Average ( chronic)

Total Residues 130 ppb 16 ppb 6 Characterization of EDWCs As Tier 1 modeling estimates, the EDWCs given in this assessment are expected to be at the high end of residue concentrations actually found in raw drinking water sources. Protective estimates of input parameters ( aerial application to maximize spray drift, maximum use rate, minimum application interval, lowest non sand Koc or Kd) were used. The FIRST model is based on a high runoff scenario ( Mississippi cotton) with a storm two days after application; few if any Tier 2 EDWCs are expected to exceed FIRST model outputs.

The SCIGROW output represents concentrations at the top of the water table immediately beneath the treated field. Concentrations in private water wells near the treated field will may be closer to SCIGROW outputs than municipal wells that draw in ground water from larger areas.

A default percent cropped area factor ( PCA) of 87% was used for the surface water assessment. This means that it was assumed that sethoxydim treated crops were grown on 87% of the acres of land in the modeled watershed. This is the highest PCA for any watershed in the continental U. S., and is used as a default value for minor crops. Lower PCA values could have been applied for the major crops on which sethoxydim is used ( soybeans, cotton, and corn). However, because there is such a great variety of uses, it is likely that there is usage on major and minor crops in the same watershed, so the crop specific PCA may not be applicable. EDWCs are proportional to the PCA used.

The EDWCs given here represent concentrations in raw drinking water sources, and do not account for possible water treatment effects. Because of the short metabolism half lives of parent sethoxydim, the EDWCs represent total residues, including M SO, M SO2, M1 S, M1 SO, M1 SO2, M2 S, M2 SO, and M2 SO2.

Scheme I represents the relationship between parent sethoxydim ( M) and its eight identified degradates. There are three groups of degradates: a group formed from the parent by oxidation of the sulfur atom ( M group), the " amines" or M1 group, and the tetrahydrobenzoxazoles, or M2 group. The first M1 group daughter ( M1 S) is formed by cleavage of the ethoxyimino group to an amino group, either by hydrolysis or aqueous photolysis. The first member of the M2 group ( M2 S) is then formed from M1 S by ring closure to produce a tetrahydrobenzoxazole ring.

Each of the three groups of degradates also has a sulfoxide ( SO) and a sulfone ( SO2), to round out the total of eight degradates. This reaction dominates in aerobic soil metabolism and soil photolysis experiments, especially to form the M SO and M SO2 degradates. 7 Scheme I M  M1 S  M2 S    M SO  M1 SO  M2 SO    M SO2  M1 SO2  M2 SO2 The eight degradates include 2 daughter products, which are formed from the parent by a single reaction ( M1 S and M SO), 3 granddaughter products that are two reactions removed from the parent ( M SO2, M2 S, and M1 SO), 2 great granddaughters that are three reactions removed ( M1 SO2 and M2 SO), and one great great granddaughter that is four reactions removed ( M2 SO2).

It is important to note that M1 SO, M2 SO, M1 SO2, and M2 SO2 may be formed by more than one pathway, and that the sulfur oxidation may be reversible under reducing conditions, so that the kinetics of the formation is very complicated, and probably cannot be elucidated with any confidence from the current fate data.

Monitoring Data Little if any monitoring data is available for sethoxydim to determine its concentration in drinking water sources. EFED is relying on modeling estimates to quantify possible drinking water exposure.

The USGS Pesticide National Synthesis Project ( http:// ca. water. usgs. gov/ pnsp/ ) did not include sethoxydim ( nor any of its degradates) in its list of pesticides for laboratory analysis of ground water and surface water samples.

The Pesticides in Ground Water Database report ( EPA 734 12 92 001, Sept. 1992) states that sethoxydim was analyzed in 65 Missouri wells in 1986, and was not detected. 8 Appendix. FIRST and SCIGROW model outputs.

RUN No. 1 FOR sethoxydim ON any * INPUT VALUES *  RATE (#/ AC) No. APPS & SOIL SOLUBIL APPL TYPE % CROPPED INCORP ONE( MULT) INTERVAL Kd ( PPM ) (% DRIFT) AREA ( IN)  .470( 1.465) 4 14 .0 4700.0 AERIAL( 16.0) 87.0 .0 FIELD AND RESERVOIR HALFLIFE VALUES ( DAYS)  METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED ( FIELD) RAIN/ RUNOFF ( RESERVOIR) ( RES. EFF) ( RESER.) ( RESER.)  54.00 2 N/ A 19.80 2455.20 44.00 43.23 UNTREATED WATER CONC ( MICROGRAMS/ LITER ( PPB)) Ver 1.0 AUG 1, 2001  PEAK DAY ( ACUTE) ANNUAL AVERAGE ( CHRONIC) CONCENTRATION CONCENTRATION  130.708 16.156 SCIGROW VERSION 2.3 ENVIRONMENTAL FATE AND EFFECTS DIVISION OFFICE OF PESTICIDE PROGRAMS U. S. ENVIRONMENTAL PROTECTION AGENCY SCREENING MODEL FOR AQUATIC PESTICIDE EXPOSURE SciGrow version 2.3 chemical: sethoxydim time is 1/ 31/ 2005 12: 31: 44  Application Number of Total Use Koc Soil Aerobic rate ( lb/ acre) applications ( lb/ acre/ yr) ( ml/ g) metabolism ( days)  0.470 4.0 1.880 2.72E+ 00 18.5  groundwater screening cond ( ppb) = 1.51E+ 00 ************************************************************************


[Federal Register Volume 76, Number 153 (Tuesday, August 9, 2011)]
[Notices]
[Pages 48925-48927]
[FR Doc No: 2011-20100]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65024; File No. SR-NASDAQ-2011-102]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Introduce a Bulk-Quoting Interface

August 3, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on July 27, 2011, The NASDAQ Stock Market LLC (``NASDAQ'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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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

    NASDAQ is filing with the Commission a proposal to introduce a
bulk-quoting interface for NASDAQ market makers that will help them
meet their obligations as market makers and to provide liquidity to the
market in an efficient manner.

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
    NASDAQ currently offers an order-based market making interface on
its options trading platform (``NOM''). Market makers use this
interface to provide a two-sided quotation on NOM. Since it is an
order-based interface, a two-sided quotation requires the entry of both
a buy and a sell order.
    As part of several technological enhancements NASDAQ plans to
implement on NOM, NASDAQ proposes to introduce a bulk-quoting interface
for market makers in order to offer an additional market making
interface choice to NASDAQ market makers. The proposed bulk-quoting
market making interface will be used by market makers to submit and
update their quotations in the marketplace much like the current order-
based interface is used today. The bulk-quoting interface, however,
allows market makers to provide both a bid and an offer in one message.
In addition, the bulk-quoting interface allows market makers to bundle
several quote updates into one bulk message. This is a useful feature
for market makers that provide quotations in many different options.
Furthermore, the bulk-quoting market making interface includes certain
data elements (described below) which

provide market makers with information that will help them meet their
obligations as market makers and to provide liquidity to the market in
an efficient manner. NASDAQ also proposes to provide this data on the
order-based market making interface (collectively, the ``Interfaces'').
    The data to be offered over the Interfaces either will be
administrative in nature or used to attract liquidity to NASDAQ in
response to an auction. NASDAQ believes the data included in this feed
is necessary for participants who have written systems to interface
with NASDAQ in the case of administrative messages or information
regarding auctions and used to attract liquidity. Though these
Interfaces are only available to market makers for quoting purposes,
non-quoting firms will be allowed to connect to the Interfaces and
receive the relevant information, but not send quotes or orders.
    Participants who have written interfaces to the NASDAQ system would
use the administrative data to determine the current state of the
trading system. For example, this data would show which symbols are
trading on NASDAQ, the current state of an options symbol (i.e., open
for trading, trading, halted or closed from trading). All of this
information is vital to a participant's quoting application and by
including this information on the Interface used for quoting,
participants can streamline their respective system architectures.
    NASDAQ holds an opening auction as an efficient and robust
mechanism to start each trading day. Additionally, NASDAQ uses an
auction to resume trading after a trading halt. During these auction
events, NASDAQ advertises the liquidity it has available for execution.
This auction information is available on other data feeds and is made
available to all exchange participants. The information being added to
these market making Interfaces is for convenience purposes so that
market participants utilizing them have an additional means to access
the information directly impacting their quoting behavior and are not
required to take other feeds simply in order to have access to these
data elements.
    A participant's quoting application will then be able to receive
these notifications over the same Interface by which it sends quotes to
NASDAQ and could then use the data to respond to auctions quickly and
efficiently. This data is not disseminated as a quote to the market
because it represents interest that is not immediately executable, but
rather interest that is currently gathering in an auction.
    Data proposed for these interfaces will initially include the
following:
    (1) Options Auction Notifications (e.g., opening imbalance,
imbalance after a halt);
    (2) Options Symbol Directory Messages;
    (3) System Event Messages (e.g., start of messages, start of system
hours, start of quoting, start of opening); and
    (4) Option Trading Action Messages (e.g., halts, resumes).
2. Statutory Basis
    NASDAQ believes that its proposal is consistent with Section 6(b)
of the Act \3\ in general, and furthers the objectives of Section
6(b)(5) of the Act \4\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general, to protect investors and the public interest.
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    \3\ 15 U.S.C. 78f(b).
    \4\ 15 U.S.C. 78f(b)(5).
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    NASDAQ believes that this proposal is in keeping with those
principles by protecting investors and the public interest, as well as
promoting just and equitable principles of trade, through the addition
of a new market making interface option for NASDAQ market makers, which
by aiding market makers in their market making activities will help to
enhance market liquidity for investors. Additionally, permitting the
Interfaces to include data elements that are administrative in nature
or that are used to attract liquidity to NASDAQ in response to the
opening auction, serves to remove impediments to and acts to perfect
the mechanism of a free and open market and a national market.

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

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

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to 19(b)(3)(A) of the Act \5\ and Rule 19b-4(f)(6)
thereunder.\6\
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    \5\ 15 U.S.C. 78s(b)(3)(A).
    \6\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file 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 satisfied this requirement.
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    A proposed rule change filed under Rule 19b-4(f)(6) \7\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\8\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing. The Exchange notes that
the proposed rule change is a non-controversial system change to data
and would not affect the execution of trades. The Exchange also notes
that it is important to its internal technology roll-out to be able to
have this proposed change in place by August 15, 2011, in order for
other technological plans to be implemented, and that prompt
implementation would extend the benefits and new features to users more
quickly. For these reasons, the Commission believes that waiving the
30-day operative delay is consistent with the protection of investors
and the public interest, and designates the proposed rule change to be
operative upon filing with the Commission.\9\
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    \7\ 17 CFR 240.19b-4(f)(6).
    \8\ 17 CFR 240.19b-4(f)(6)(iii).
    \9\ For purposes only of waiving the operative delay for this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2011-102 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-NASDAQ-2011-102. 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 the filing also will be
available for inspection and copying at the principal office of the
Exchange. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
NASDAQ-2011-102 and should be submitted on or before August 30, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
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    \10\ 17 CFR 200.30-3(a)(12).
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Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-20100 Filed 8-8-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: July 9, 2009 (Volume 74, Number 130)]
[Rules and Regulations]
[Page 32802-32803]
[DOCID:fr09jy09-4]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0046; Directorate Identifier 2008-NE-05-AD;
Amendment 39-15962; AD 2009-14-12]
RIN 2120-AA64

Airworthiness Directives; Pratt & Whitney Canada Corp. (P&WC)
Models PW305A and PW305B Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) issued 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:

    P&WC has determined that the Post-Service Bulletin (SB) PW300-
72-24287 High Pressure Compressor (HPC) drum rotor assemblies P/N
30B2478 and 30B2542 on PW 305A and 305B engines with single stage
coated labyrinth seals, are susceptible to developing significant
cracks in the region of the labyrinth seal.

We are issuing this AD to detect cracks in the HPC drum rotor assembly,
which could lead to an uncontained failure of the drum rotor assembly
and damage to the airplane.

DATES: This AD becomes effective August 13, 2009.

ADDRESSES: The Docket Operations office is located at Docket Management
Facility, U.S. Department of Transportation, 1200 New Jersey Avenue,
SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-
0001.

FOR FURTHER INFORMATION CONTACT: Ian Dargin, Aerospace Engineer, Engine
Certification Office, FAA, Engine & Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on February 20, 2009
(74 FR 7836). That NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    P&WC has determined that the Post-Service Bulletin (SB) PW300-
72-24287 High Pressure Compressor (HPC) drum rotor assemblies P/N
30B2478 and 30B2542 on PW 305A and 305B engines with single stage
coated labyrinth seals, are susceptible to developing significant
cracks in the region of the labyrinth seal.
    P&WC issued SB PW300-72-24462 for initial inspection of affected
HPC drum rotor assemblies for cracks. In addition, the PW305
Maintenance Manual (MM) 05-20-00 was revised (Revision No. 26)
accordingly, to add requirement for repeat inspection interval. A
new P/N 31B6325-01, HPC drum rotor assembly, which is not
susceptible to subject cracking, is made available through SB PW300-
72-24376, as terminating action for the required repeat inspection.
    Recent data (Ref: SIL: PW300-093) indicate that a number of
high-time Pre-SB-PW300-72-24376 HPC drum rotor assemblies (P/N
30B2478 and 30B2542), with potential for a hazardous disk failure in
consequence of non-compliance with the inspection requirements, are
still in-service. This AD is issued to mandate the inspection of the
affected P/N 30B2478 and 30B2542 HPC drum rotor assemblies in
accordance with PW305-MM-05-20-00 requirements.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting the AD as proposed.

Costs of Compliance

    Based on the service information, we estimate that this AD will
affect about 540 products of U.S. registry. We also estimate that it
will take about 10 work-hours per product to comply with this AD. The
average labor rate is $80 per work-hour. Required parts will cost about
$5,000 per product. Based on these figures, we estimate the cost of the
AD on U.S. operators to be $3,132,000. Our cost estimate is exclusive
of possible warranty coverage.

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.

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 provided in
the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, 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:

2009-14-12 Pratt & Whitney Canada Corp: Amendment 39-15962. Docket
No. FAA-2009-0046; Directorate Identifier 2008-NE-05-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective August
13, 2009.

Affected ADs

    (b) None.
    (c) This AD applies to Pratt & Whitney Canada Corp. (P&WC)
Models PW305A and PW305B turbofan engines with high pressure
compressor (HPC) drum rotor assemblies, post P&WC Service Bulletin
(SB) PW300-72-24287 but without P&WC SB PW300-72-24376, installed.
These engines are installed on, but not limited to, Bombardier
Learjet M60 and Hawker Beechcraft 1000 series airplanes.

Reason

    (d) P&WC has determined that the Post-Service Bulletin (SB)
PW300-72-24287 High Pressure Compressor (HPC) drum rotor assemblies
P/N 30B2478 and 30B2542 on PW305A and 305B engines with single stage
coated labyrinth seals, are susceptible to developing significant
cracks in the region of the labyrinth seal.

We are issuing this AD to detect cracks in the HPC drum rotor
assembly, which could lead to an uncontained failure of the drum
rotor assembly and damage to the airplane.

Actions and Compliance

    (e) Unless already done, do the following actions.
    (1) Within 500 flight hours after effective date of this
directive, borescope-inspect the interiors of affected HPC rotor
assemblies for cracks. If a crack is found, remove the engine before
next flight for HPC drum rotor replacement. Pratt & Whitney
Maintenance Manual, Chapter 72-00-00, contains guidance on borescope
inspection.

Credit for Previous Inspections

    (2) Inspection of affected HPC drum rotor assembly per P&WC SB
PW300-72-24462 and or SB PW305 MM 05-20-00 inspection requirements
prior to the effective date of this directive satisfies the
requirements of paragraph (e)(1) of this AD.
    (3) Repeat borescope inspection per paragraph (e)(1) of this AD,
at intervals not exceeding 1,350 flight cycles. If a crack is found,
remove the engine before next flight for HPC rotor drum replacement.

Optional Terminating Action

    (4) Replacement of the affected HPC rotor assembly P/N 30B2478
or 30B2542 with Post-SB PW300-72-24376 assembly P/N 31B6325-01 or
later superseding P/N, will constitute terminating action for the
inspection requirements of the above paragraphs (e)(1) and (e)(2) of
the corrective action requirements of this AD.

Other FAA AD Provisions

    (f) Alternative Methods of Compliance (AMOCs): The Manager,
Engine Certification Office, FAA, has the authority to approve AMOCs
for this AD, if requested using the procedures found in 14 CFR
39.19.

Related Information

    (g) Refer to Canadian Airworthiness Directive CF-2007-25R1,
dated February 13, 2008, and P&WC SB PW300-72-24462, dated December
13, 1999, for related information. Contact Pratt & Whitney Canada
Corp., 1000 Marie-Victorin, Longueuil, Quebec, Canada J4G 1A1,
telephone:<PHONE_NUMBER>, for a copy of this service information.
    (h) Contact Ian Dargin, Aerospace Engineer, Engine Certification
Office, FAA, Engine & Propeller Directorate, 12 New England
Executive Park, Burlington, MA 01803; e-mail<EMAIL_ADDRESS>
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>, for more information
about this AD.

Material Incorporated by Reference

    (i) None.

    Issued in Burlington, Massachusetts, on June 30, 2009.
Francis A. Favara,
Manager, Engine and Propeller Directorate, Aircraft Certification
Service.
[FR Doc. E9-16111 Filed 7-8-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 105 (Friday, May 31, 2013)]
[Notices]
[Pages 32668-32669]
[FR Doc No: 2013-12923]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1999-D-3528 (Formerly Docket No. 99D-5046)]

Draft Guidance for Industry: Changes to an Approved Application:
Biological Products: Human Blood and Blood Components Intended for
Transfusion or for Further Manufacture; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft document entitled ``Guidance for Industry:
Changes to an Approved Application: Biological Products: Human Blood
and Blood Components Intended for Transfusion or for Further
Manufacture'' dated June 2013. The draft guidance document provides
manufacturers of licensed Whole Blood and blood components intended for
transfusion or for further manufacture, including Source Plasma, with
recommendations intended to assist with determining which reporting
mechanism is appropriate for submission of changes to an approved
biologics license application. The guidance document also provides
manufacturers of licensed Whole Blood and blood components
recommendations in connection with the applicability and content of
comparability protocols and labeling changes. The draft guidance, when
finalized, is intended to supersede the document of the same title
dated July 2001 (July 2001 guidance).

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 29, 2013.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Outreach and Development (HFM-
40), Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist the office in
processing your requests. The draft guidance may also be obtained by
mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Jonathan R. McKnight, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled
``Guidance for Industry: Changes to an Approved Application: Biological
Products: Human Blood and Blood Components Intended for Transfusion or
for Further Manufacture'' dated June 2013. The document provides
manufacturers of licensed Whole Blood and blood components intended for
transfusion or for further manufacture, including Source Plasma, with
recommendations intended to assist with determining which reporting
mechanism is appropriate for submission of changes to an approved
biologics license application in accordance with the requirements under
Title 21 Code of Federal Regulations 601.12 (21 CFR 601.12). The
guidance document also provides manufacturers of licensed Whole Blood
and blood components with recommendations in connection with the
applicability and content of comparability protocols under 21 CFR
601.12(e) and labeling changes under 21 CFR 601.12(f). Frequently, a
manufacturer of a licensed product determines that it is appropriate to
make a change in its product, production process, quality controls,
equipment, facilities, responsible personnel, or labeling as documented
in its approved biologics license application(s). Section 601.12 (21
CFR 601.12) states the requirements to report such changes for licensed
biological products to FDA.
    The recommendations contained in the guidance document reflect
current FDA and industry experience with reporting changes to an
approved application, including reporting the implementation of new
technologies. The recommendations have been revised for reporting
categories for certain changes to an approved application that is in
the July 2001 guidance based on the experience gained over the last
decade. The draft guidance, when finalized, is intended to supersede
the document of the same title dated July 2001, published in the
Federal Register of August 7, 2001 (66 FR 41247).
    The draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent FDA's current thinking on this topic. It does
not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirement of the applicable statutes
and regulations.

II. Paperwork Reduction Act of 1995

    The draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 601.12, Form FDA 2567, and Form
FDA 356h have been approved under OMB control number 0910-0338; the
collections of information in 21 CFR 607.21, 607.26, and Form FDA 2830
have been approved under OMB control number 0910-0052; the collections
of information in 21 CFR 606.121, 606.170, and 610.40 have been
approved under OMB control number 0910-0116; and the collections of
information in 21 CFR 600.14 has been approved under OMB control number
0910-0458.

III. Comments

    The draft guidance is being distributed for comment purposes only
and is not intended for implementation at this time. Interested persons
may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets
Management (see ADDRESSES). It is only necessary to send one set of
comments. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: May 24, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-12923 Filed 5-30-13; 8:45 am]
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