[Federal Register Volume 77, Number 221 (Thursday, November 15, 2012)]
[Notices]
[Pages 68193-68194]
[FR Doc No: 2012-27719]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68190; File No. SR-NYSEArca-2012-95]

Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting
Approval of Proposed Rule Change, as Modified by Amendment No. 1, To
Amend Commentary .07 to NYSE Arca Options Rule 6.4 To Expand the Number
of Expirations Available Under the Short Term Option Series Program
(``STOS Program''), To Allow for the Exchange To Delist Series in the
STOS Program That Do Not Have Open Interest, and To Expand the Number
of Series in the STOS Program Under Limited Circumstances

 November 8, 2012.

I. Introduction

    On September 6, 2012, NYSE Arca, Inc. (``NYSE Arca'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend Commentary .07 to NYSE Arca Options Rule
6.4 (``Commentary .07'') to make certain modifications to the
Exchange's Short Term Option Series Program (``STOS Program''). The
proposed rule change was published for comment in the Federal Register
on September 26,

2012.\3\ The Commission received no comment letters on the proposal.
This order approves the proposed rule change, as modified by Amendment
No. 1.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 67898 (September 20,
2012), 77 FR 59233 (``Notice''). The Commission notes that on
September 18, 2012, the Exchange submitted Amendment No. 1 to the
proposed rule change to make certain amendments that, in part,
clarified the circumstances in which the Exchange will delist series
with no open interest.
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II. Description of the Proposal

    The Exchange proposes to amend Commentary .07 to (i) expand the
number of expirations available under the STOS Program; (ii) allow the
Exchange to delist, in certain circumstances, series in the STOS
program that do not have open interest; and (iii) allow the Exchange to
list, in certain circumstances, additional series in the STOS program.
    The proposed rule change allows the Exchange to open a maximum of
five consecutive expirations under the STOS Program for trading on the
Exchange. The Exchange notes that it will not add expirations in a STOS
series if such expirations would coincide with an existing expiration
of a monthly or quarterly series of an option in the same class of the
STOS series.
    The proposed rule change also amends the circumstances in which the
Exchange may delist or list series in the STOS Program. Specifically,
the proposed rule change provides that the Exchange will delist series
in the STOS Program with no open interest in both the call and the put
series having a: (i) Strike price higher than the highest strike price
with open interest in the put and/or call series for a given expiration
month; and (ii) strike price lower than the lowest strike price with
open interest in the put and/or call series for a given month, so as to
list series that are at least 10% but not more than 30% above or below
the current price of the underlying security. The Exchange would also
be permitted, under the proposed rule change, to list additional series
in excess of the 30 series otherwise allowed \4\ under Commentary .07
that are between 10% and 30% above or below the price of the underlying
security. The Exchange will only be allowed to delist or list series in
accordance with the proposed rule change in the event that the
underlying security has moved so that there are no series that are at
least 10% above or below the current price of the underlying security.
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    \4\ Commentary .07(a) provides, in part, that for each option
class eligible for participation in the STOS Program, the Exchange
may open up to 30 Short Term Option Series for each expiration date
in that class.
---------------------------------------------------------------------------

    The Exchange asserts that the ability to list five consecutive
expirations under the STOS Program is designed to meet increased
customer demand and provide market participants with the ability to
hedge in a greater number of option classes and series.\5\ The Exchange
also claims that the proposed amendments regarding delisting or listing
STOS series are designed to provide investors flexibility by ensuring
that there are series within the band of at least 10% but not more than
30% above or below the current price of the underlying security.\6\
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    \5\ See Notice, supra note 3 at 59233.
    \6\ See id. at 59234.
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III. Discussion and Commission Findings

    After careful review of the proposed rule change, the Commission
finds that the proposed rule change is consistent with the requirements
of the Act and the rules and regulations thereunder applicable to a
national securities exchange.\7\ Specifically, the Commission finds
that the proposal is consistent with Section 6(b)(5) of the Act,\8\
which requires, among other things, that the rules of a national
securities exchange be designed to promote just and equitable
principles of trade, to prevent fraudulent and manipulative acts, to
remove impediments to and perfect the mechanism of a free and open
market and a national market system, and, in general, to protect
investors and the public interest. The Commission believes that the
proposed change may provide the investing public and other market
participants with greater flexibility to closely tailor their
investment and hedging decisions in a greater number of series, thus
allowing investors to better manage their risk exposure.
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    \7\ In approving this proposed rule change, the Commission
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \8\ 15 U.S.C. 78f(b)(5).
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    In approving this proposal, the Commission notes that the Exchange
has represented that it and OPRA have the necessary systems capacity to
handle the potential additional traffic associated with opening of up
to five consecutive expirations under the STOS Program.\9\ The
Commission expects the Exchange to monitor the trading volume
associated with the additional options series listed as a result of
this proposal and the effect of these additional series on market
fragmentation and on the capacity of the Exchange's, OPRA's, and
vendors' automated systems.
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    \9\ See Notice, supra note 3 at 59233.
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IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\10\ that the proposed rule change, as modified by Amendment No. 1,
(SR-NYSEArca-2012-95) be, and it hereby is, approved.
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    \10\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-27719 Filed 11-14-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 198 (Wednesday, October 14, 2015)]
[Notices]
[Page 61822]
[FR Doc No: 2015-26052]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0128]

Prescription Drug User Fee Act; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening until
April 29, 2016, the comment period for the notice of public meeting
that appeared in the Federal Register of May 13, 2015 (80 FR 27323). In
the notice of public meeting, FDA invited public comment as the Agency
begins the process to reauthorize the Prescription Drug User Fee Act
(PDUFA) in fiscal years (FYs) 2018 to 2022. The Agency is taking this
action to allow interested persons additional time to submit comments.

DATES: FDA is reopening the comment period on the notice of public
meeting published May 13, 2015 (80 FR 27323). Submit either electronic
or written comments by April 29, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2010-N-0128 for ``Prescription Drug User Fee Act; Reopening of
Comment Period.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at http://www.regulations.gov or at the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Graham Thompson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 301-
796-5003.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 13, 2015, FDA
published a notice of public meeting with a 30-day comment period
following the public meeting and invited comments as the Agency began
the process to reauthorize PDUFA in FYs 2018 to 2022.
    FDA is reopening the comment period until April 29, 2016. The
Agency believes that reopening the comment period for the notice of
public meeting will allow adequate time for interested persons to
submit comments.

    Dated: October 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-26052 Filed 10-13-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: June 12, 2006 (Volume 71, Number 112)]
[Notices]
[Page 33746-33747]
[DOCID:fr12jn06-82]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of FERC Staff Attendance at Meetings of Southwest Power
Pool Board of Directors/Members Committee and Southwest Power Pool
Regional State Committee

June 6, 2006.
    The Federal Energy Regulatory Commission hereby gives notice that
members of its staff may attend the meetings of the Southwest Power
Pool (SPP) Board of Directors/Members Committee and Regional State
Committee noted below. Their attendance is part of the Commission's
ongoing outreach efforts.
    SPP Board of Directors/Members Committee--June 12-13, 2006 (June
12: 5:30 p.m.-8 p.m. CDT; June 13: 8 a.m.-5 p.m. CDT). SPP Offices,
Plaza West Bldg., 415 N. McKinley, Suite 140, Little Rock, AR 72205.
501-614-3200.
    July 25, 2006 (8:30 a.m.-3 p.m. CDT). Embassy Suites Hotel/Kansas
City Plaza, 220 West 43rd Street, Kansas City, MO 64111.<PHONE_NUMBER>.

    SPP Regional State Committee--July 24, 2006 (1 p.m.-5 p.m. CDT).
Embassy Suites Hotel/Kansas City Plaza, 220 West 43rd Street, Kansas
City, MO 64111.<PHONE_NUMBER>.
    The discussions may address matters at issue in the following
proceedings:
Docket Nos. RT04-1 and ER04-48, Southwest Power Pool, Inc.
Docket No. ER05-109, Southwest Power Pool, Inc.
Docket No. ER05-652, Southwest Power Pool, Inc.
Docket No. ER05-799, Southwest Power Pool, Inc.
Docket No. ER05-1065, Entergy Services, Inc.
Docket No. ER05-1285, Southwest Power Pool, Inc.
Docket No. ER05-1352, Southwest Power Pool, Inc.
Docket No. ER05-1416, Southwest Power Pool, Inc.
Docket No. ER06-15, Southwest Power Pool, Inc.
Docket No. ER06-432, Southwest Power Pool, Inc.
Docket No. ER06-448, Southwest Power Pool, Inc.
Docket No. ER06-451, Southwest Power Pool, Inc.
Docket No. ER06-641, Southwest Power Pool, Inc.
Docket No. ER06-727, Southwest Power Pool, Inc.
Docket No. ER06-729, Southwest Power Pool, Inc.
Docket No. ER06-767, Southwest Power Pool, Inc.
    The meeting is open to the public. For more information, contact
Tony Ingram, Office of Energy Markets and Reliability, Federal Energy
Regulatory Commission at<PHONE_NUMBER> or<EMAIL_ADDRESS>
Magalie R. Salas,
Secretary.
 [FR Doc. E6-9097 Filed 6-9-06; 8:45 am]

BILLING CODE 6717-01-P


     1    39 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM Date: April 1, 2005 Subj: Study Review: Azinphos methyl  Biomonitoring of Applicators Following Airblast Treatment of Orchard Crops using Open and Closed Cab Equipment ( MRID#: 463164 06, PC Code( s) : 058001, DP Barcode 307562)

From: Seyed Tadayon, Chemist Reregistration Branch 3 ( 7509C) Health Effects Division Through: Danette Drew, Branch Senior Scientist Reregistration Branch 3 ( 7509C) Health Effects Division To: Seyed Tadayon, Chemist Reregistration Branch 3 ( 7509C) Health Effects Division Attached is a review of the study entitled, Azinphos methyl  Biomonitoring of Applicators Following Airblast Treatment of Orchard Crops using Open and Closed Cab Equipment A primary review of the study was performed by Versar, Inc. under the supervision of HED. It has undergone secondary review in HED and has been revised to reflect Agency policies.      2    39 STUDY TYPE Azinphos methyl  Biomonitoring of Applicators Following Airblast Treatment of Orchard Crops using Open and Closed Cab Equipment TEST MATERIAL Azinphos methyl SYNONYMS GUTHION ® ; S( 3,4 dihydro 4 oxobenzo[ d][ 1,2,3] trizin 3 ylmethyl) O, O dimethyl phosphorodithioate; O, O dimethyl S[( 4 oxo 1,2,3 benzotriazin 3( 4H) yl) methyl] phosphorodithioate CITATION Study Author: M. E. Krolski Title: Azinphos methyl  Biomonitoring of Applicators Following Airblast Treatment of Orchard Crops using Open and Closed Cab Equipment Report Date: July 7, 2004 Analytical Laboratories: Bayer CropScience Environmental Research Section Bayer Research Park 17745 South Metcalf Avenue Stilwell, KS 66085 Identifying Codes: MRID: 463164 06 Report No.: 201054 Study Number: GU264704 and GU264705 PSI Number: RAGUY012 and RCGUX002 SPONSOR Bayer CropScience Product Safety Management 2 T. W. Alexander Drive Research Triangle Park, NC 27709 COMPLIANCE Signed and dated GLP, Data Confidentiality statements, and Quality Assurance statements were provided in the Study Report. The Study Report states that it meets FIFRA Good Laboratory Practices 40 CFR part 160 with the following exceptions: ( 1) some plot diagrams were updated and the initial entries are not available in the electronic raw data, ( 2) trials GU 020 03D and GU 024 03D do not have chain of custody or storage documentation for the associated field fortification samples, ( 3) some field observations for trial GU 020 03D were not made according to GLP, ( 4) sample      3    39 receipt dates and weight values were recorded into a laboratory information management system that was not validated, and ( 5) the storage container used in this study were not retained for the duration of the study as required by 160,105( c). The statement noted that none of these exceptions negatively impacted the integrity of the study.

GUIDELINE OR PROTOCOL FOLLOWED: The Bayer CropScience Protocol for both the open cab study ( GU264704) and the closed cab study ( GU264705) were provided in the Study Report, including a list of deviations. The Study Report states that the data requirements were U. S. EPA OPPTS Harmonized Test Guidelines, Series 875 Occupational and Residential Exposure, 875.1500  Biological Monitoring.

I. MATERIALS AND METHODS A. MATERIALS Formulation: GUTHION ® 50 WP  water soluble packets ( GUTHION ® Solupak) EPA Reg. No. 264 733 Lot/ Batch # formulation: 3144145, 3144032 Purity: The purity of the batch was verified at 49.91% azinphos methyl with an expiration date of April 23, 2005. CAS #( s): CAS 86 50 0 Packaging: The product was supplied in bags containing the water soluble packets.

B. STUDY DESIGN There were 2 amendments to the protocol and 7 deviations from the protocol for open cab trials.

The amendments included:( 1) the addition of two more control urine timepoints for trials GU031 03D, GU033 03D, and GU034 03D; and ( 2) the addition of analysis methods and spiking levels.

The deviations included: ( 1) SOP= SOO214 requires that QA review protocols prior to study initiation and this was not done; ( 2) protocol definition of a typical workday ( 4 8 hours) was exceed during trials GU020 03D, GU021 03D, GU022 03D, and GU023 03D; ( 3) the reporting frequency of FieldNotes updates as required by the protocol was not met during trials GU020 03D, GU021 03D, GU022 03D, GU023 03D, GU024 03D, GU025 03D, and GU026 03D; ( 4) the Master Schedule Form F 00066 was not sent promptly after application during trials GU022 03D, GU023 03D, GU024 03D, GU025 03D, and GU026 03D; ( 5) the minimum 14 day period ( prior to testing) in which a volunteer could not be exposed to azinphos methyl was not met during trials GU022 03D, GU023 03D, GU024 03D, GU025 03D, and GU026 03D; ( 6) the sprayer was not calibrated prior to each use during trial GU022 03D; and ( 7) the protocol requirement of a 7 hour minimum exposure period for air samples was not achieved during trials GU024 03D, GU025 03D and GU026 03D.      4    39 There were 2 amendments and 10 deviations from the protocol for the closed cab trials. The amendments included:

( 1) the addition of two more control urine timepoints for trials GU031 03D, GU033 03D, and GU034 03D; and ( 2) the addition of analysis methods and spiking levels.

The deviations included: ( 1) SOP= SOO214 requires that QA review protocols prior to study initiation and this was not done; ( 2) the FieldNotes summary was not sent to the Study Director within 30 days of trial completion for trials GU035 03D through GU044 03D; ( 3) the electronic file was not transferred to the Study Director within 24 hours of critical phase for trials GU035 03D through GU044 03D; ( 4) cultural practices, weather information, and pesticide history were not collected per GLP for trials GU035 03D through GU044 03D; ( 5) records of sprayer cleaning and maintenance were not available for trials GU035 03D through GU044 03D; ( 6) the final electronic file was to be sent to the sponsor within 30 days of the final event ( last samples disposed of on Sept. 10th) for trials GU035 03D through GU044 03D; ( 7) the Master Schedule Form F 00066 was not sent promptly after application for trial GU045 03D; ( 8) the protocol requirement of a 7 hour minimum exposure period for air samples was not achieved for trial GU045 03D; ( 9) the reporting frequency of FieldNotes updates as required by the protocol was not met for trials GU045 03D through GU047 03D; ( 10) the protocol definition of a typical workday ( 4 8 hours) was exceeded for trials GU046 03D and GU047 03D.

These deviations from the protocol were reported to not have any adverse effects on the study.

1. Test Site Thirty field trials were conducted: 15 using open cab equipment and 15 using closed cab equipment . The open cab field trials were held in PA , MD and WA. The closed cab field trials were held in NY ( 1 trial), North Rose, NY, PA and WA.

The plot sizes for the open cab field trials ranged from 20 to 120 acres, averaging 33 acres, and the plot sizes for the closed cab field trials ranged from 1.0 to 60 acres, averaging 12 acres. The field trials were mostly conducted on apple orchards, although one of the open cab trials ( GU026 03D) specified that applications were made to apples and stone fruit.

2. Meteorology:

Meteorological conditions were recorded during the application. The Study Report noted that none of the field sites, except for an open cab trial site ( GU021 03D) which reported 0.1 inch, reported any rainfall. None of the field sites reported any use of irrigation from the first application through the last sampling.      5    39 3. Number and type of workers Thirty workers participated in the study. Fifteen made applications using closed cab tractors and fifteen using open cab tractors. The weight of the workers using open cab tractors ranged from 66 to 98 kg, averaging 83 kg. The weight of the workers using closed cab tractors ranged from 70 to 116 kg, averaging 88 kg. All workers were reported to be professional orchardmen. Data from three of the worker replicates from the open cab study were excluded from the data analysis of dose estimation due to high background MSMB residue levels.

4. Replicates The specific activities including mixing/ loading and application by the workers were not described in the Study Report. Exposure periods were reported for each trial and averaged 7 hours, 12 minutes for the open cab trials and 8 hours, 13 minutes for the closed cab trials.

5. Protective clothing The Study Report stated that the workers wore protective clothing and respiratory protection as specified on the product label. For open cab field trials, the Study Report states that during application workers wore: ( 1) one or two piece chemical resistant coveralls made from TYVEK, SARANEX, PVC or similar material , ( 2) long sleeved shirt and long pants, ( 3) chemical resistant footwear plus socks, ( 4) chemical resistant gloves, ( 5) chemical resistant headgear, and ( 6) protective eyewear. In addition, workers wore a respirator with either an organic vapor removing cartridge with a prefilter approved for pesticides, a canister approved for pesticides, or a NIOSH approved respirator with an organic vapor cartridge or canister with any N, R, P, or HE prefilter. During mixing/ loading operations, workers wore a minimum of long sleeved shirt, long pants, chemical resistant gloves, shoes plus socks, protective eyewear, and a chemical resistant apron.

For closed cab field trials, the Study Report states that workers wore long sleeved shirts, long pants, and shoes plus socks. Additional PPE was provided for functions requiring it, such as additional mixing/ loading and equipment adjustment. During mixing/ loading operations, the worker wore a long sleeved shirt, long pants, chemicalresistant gloves, protective eyewear, shoes plus socks and a chemical resistant apron. The Registrant provided a complete description of PPE used in each trail ( not provided in the Study Report).

6. Application Method and Rate Application rate( s): According to the label the maximum application rate recommended for apples is 1.5 lb ai/ acre. The application rates for the open cab trials averaged 0.911 lb ai/ acre and for the closed cab trials averaged 1.407 lb ai/ A Application Equipment: Applications were made with open and closed cab tractordrawn airblast sprayers      6    39 Spray Volume: Spray volumes reported for the open cab trials ranged from 10.2 and 109.8 gal/ acre and spray volumes reported for the closed cab trials ranged from 43.5 to 102.7 gal/ acre.

Equipment Calibration: The authors reported that the sprayers were calibrated prior to the application.

7. Exposure monitoring methodology Urine Samples Total 24 hour urine output was collected from each worker performing mixer/ loader/ applicator activities for the time period including the day before mixer/ loader/ applicator activities til 4 days after mixer/ loader/ applicator activities. Day  1 samples were those collected starting after the first void of the bladder in the morning on the day prior to exposure and ending after the first void on the day of exposure prior to initiation of mixer/ loader/ applicator activities. Day 0 samples were those collected during the 24 hour period following the beginning of exposure. Samples were kept in refrigerators in individual containers during the 24 hour collection time. After collection of each 24 hour bulk sample, the total volume of each sample was recorded. The samples were mixed by shaking, and duplicate 50 mL aliquots were transferred to separate containers. The bulk samples and aliquots were kept frozen between collection and shipment.

Breathing Zone Air Samples Potential inhalation was measured using OVS tubes and a personal air sampling pump with the inlet positioned near the face of the worker. The air sampling pumps were calibrated prior to use and the flow rate was approximately 2 L/ min. At the end of the work day, the OVS tubes were placed into individually labeled plastic bags and stored in a freezer until shipment .

C. ANALYTICAL METHODOLOGY:

1. Sample Extraction/ Detection:

Urine Samples Extraction method: An MSMB d 3 internal standard was added to a 10 mL aliquot of urine. The sample was applied to a 10 mL Chem Elut cartridge and the cartridge was eluted with three 20 mL portions of methylene chloride into a 60 mL vial. The methylene chloride was evaporated and the residue was dissolved in 1 mL of 10% aqueous methanol. The resulting solution was analyzed by LC/ MS MS.

Detection methods: See Table 1.

Table 1. Summary of Chromatographic Conditions for Urine GC Column Zorbax SB Aq, 5 µ m, 50 mm x 2.1 mm      7    39 Table 1. Summary of Chromatographic Conditions for Urine Solvents 0.1% aqueous formic acid ( solvent A) and methanol ( solvent B)

Solvent Program Time ( min) Solvent A(%) Solvent B(%) Flow ( mL/ min) Initial 68 32 0.200 2.5 68 32 0.200 2.85 15 85 0.200 2.90 68 32 0.300 5.00 68 32 0.300 5.05 68 32 0.200 Injection Volume Autosampler with a 20 µ L loop Instrument performance and calibration: Calibration curves were prepared for each calibration run. The limit of quantitation for urine samples was reported to be 0.5 ng/ mL and the limit of detection was reported to be 0.08 ng/ mL. Method validation recoveries were reported by the study author and verified by HED. Average recoveries ranged from 86% to 94%.

Quantification: The MSMB residue level in urine was determined by comparing the LC/ MS measurement of MSMB to the measurement of the MSMB internal standard.

Breathing Zone Air Samples The top and bottom sections of the OVS tubes were analyzed separately. The top portion of the OVS tube ( including the retaining ring, filter, upper layer of XAD 2 resin, and the upper foam ring) was disassembled and placed into a labeled 40 mL vial. The bottom portion of the OVS tube ( lower layer of XAD 2 resin and lower foam plug) was disassembled and placed into a separate, labeled 40 mL vial. Each sample received 10 mL of acetonitrile and an internal standard solution, which contained a mixture of dueterated azinphos methyl ( 1.0 µ g) and azinphos methyl oxon ( 0.2 µ g). Each sample was then sonicated for 2 minutes and a 0.25 mL aliquot was removed and diluted with 0.75 mL of water. The diluted samples were analyzed by LC/ MS MS.

Detection methods: See Table 2 Table 2. Summary of Chromatographic Conditions for OVS Tubes GC Column Xterra MS C18, 3.5 µ m, 50 mm x 4.6 mm Solvents 0.1% aqueous formic acid ( solvent A) and methanol ( solvent B)

Solvent Program Isocratic at 38% Solvent A and 62% Solvent B Flow Rate 1.00 mL/ min Injection Volume Autosampler with a 20 µ L loop Instrument performance and calibration: Calibration curves were prepared for each calibration run. The limit of quantitation for both azinphos methyl and azinphosmethyl oxon was reported to be 100 ng. The limit of detection for azinphos methyl was reported to be 5 ng and the limit of detection for azinphos methyl oxon was reported to be 9 ng. Method validation recoveries for OVS tubes were reported by the study author and verified by HED, using ½ the LOD when values were reported as less than the LOD.      8    39 Average recoveries ranged from 90% to 107% for azinphos methyl and from 86% to 102% for azinphos methyl oxon.

Quantification: The azinphos methyl or azinphos methyl oxon residue level in OVS tubes was determined by comparing the LC/ MS measurement of azinphos methyl or azinphos methyl oxon to the measurement of the azinphos methyl or azinphos methyl oxon internal standard.

2. Quality Control:

Lab Recovery: Concurrent laboratory recoveries were performed for both urine samples and for the OVS tube samples. Urine samples were fortified at the 0.50 ng/ mL level and OVS tubes were fortified at the 500 ng level. HED verified the results provided in the Study Report and these are presented in Tables 3 and 4.

Table 3. Urine Sample Concurrent Laboratory Recoveries Sample No. Fortification Level ( ng/ mL) Measured residue ( ng/ mL) Average Blank Sample Residue ( ng/ mL) Corrected residuea ( ng/ mL) Percent Recovery (%) Average Recovery (%) Overall Average Recovery (%)

Open cabs ( Trials GU020 03D through GU034 03D)

0.413 0.402 80 GU020 03D 0.514 0.011 0.503 101 91 0.447 0.406 81 GU022 03D 0.555 0.041 0.514 103 92 0.591 0.571 114 GU024 03D 0.5 0.02 0.48 96 105 0.428 0.424 85 GU027 03D 0.425 0.004 0.421 84 84 0.432 0.395 79 GU029 03D 0.439 0.037 0.402 80 86 0.489 0.482 96 GU031 03D 0.44 0.007 0.433 87 95 0.561 0.549 110 GU033 03D 0.442 0.012 0.43 86 92 0.474 0.46 92 GU045 03D ( closed cab sample, but analyzed with additional samples in open cab trial) 0.5 0.48 0.014 0.466 93 93 92 Closed cabs ( Trials GU035 03D through GU049 03D)

0.451 0.437 87 GU036 03D 0.453 0.014 0.439 88 88 0.455 0.447 89 GU037 03D 0.46 0.008 0.452 90 90 0.457 0.454 91 GU041 03D 0.509 0.003 0.506 101 97 0.467 0.462 92 GU042 03D 0.53 0.005 0.525 105 96 0.474 0.46 92 GU045 03D 0.48 0.014 0.466 93 97 0.566 0.529 106 GU046 03D 0.5 0.037 92 93      9    39 Table 3. Urine Sample Concurrent Laboratory Recoveries Sample No. Fortification Level ( ng/ mL) Measured residue ( ng/ mL) Average Blank Sample Residue ( ng/ mL) Corrected residuea ( ng/ mL) Percent Recovery (%) Average Recovery (%) Overall Average Recovery (%)

0.512 0.475 95 0.468 0.452 90 GU048 03D 0.401 0.016 0.385 77 84 a Corrected residue is the measured residue minus the average blank residue.      10    39 Table 4. OVS Tubes Concurrent Laboratory Recoveries Trial Number Fortification Level ( ng) Measured Bottom Residue ( ng) Bottom Blank Residues ( ng) Corrected Bottom Residuea ( ng) Measured Top Residue ( ng) Top Blank Residues ( ng) Corrected Top Residuea ( ng) Total Residue ( top + bottom) ( ng) Percent recovery (%) Average Percent Recovery (%)

Open cabs ( Trials GU020 03D through GU034 03D)

Azinphos methyl ( AZM)

GU020 03D 9.8 20.9 < LODb 538.9 17 521.9 524.4 105 GU024 03D 29.5 30.3 < LOD 546.1 34.6 511.5 514 103 GU027 03D 9.6 11.7 < LOD 517.9 44.7 473.2 475.7 95 GU031 03D < LOD 11.6 < LOD 502.3 7.6 494.7 497.2 99 GU045 03Dc 500 7 12.2 < LOD 538.9 16 522.9 525.4 105 101 Azinphos methyl oxon ( AZM oxon)

GU020 03D < LOD < LOD < LOD 479.1 < LOD 474.6 479.1 96 GU024 03D < LOD < LOD < LOD 492.2 < LOD 487.7 492.2 98 GU027 03D < LOD < LOD < LOD 478.7 < LOD 474.2 478.7 96 GU031 03D < LOD < LOD < LOD 501.6 < LOD 497.1 501.6 100 GU045 03Dc 500 < LOD < LOD < LOD 480.4 < LOD 475.9 480.4 96 97 Closed cabs ( Trials GU035 03D through GU049 03D)

AZM GU020 03Dc 9.8 20.9 < LOD 538.9 17 521.9 524.4 105 GU035 03D < LOD < LOD < LOD 513.6 < LOD 511.1 513.6 103 GU045 03D 7 12.2 < LOD 538.9 16 522.9 525.4 105 GU048 03 Dc 500 5.5 28.2 < LOD 506.4 10.2 496.2 498.7 100 103 AZM oxon GU020 03Dc < LOD < LOD < LOD 479.1 < LOD 474.6 479.1 96 GU035 03D < LOD < LOD < LOD 467.8 < LOD 463.3 467.8 94 GU045 03D < LOD < LOD < LOD 480.4 < LOD 475.9 480.4 96 GU048 03 D 500 < LOD < LOD < LOD 468.2 < LOD 463.7 468.2 94 95 a Corrected residue is the measured residue minus the average blank residue.

b If values were < LOD, ½ LOD was used in calculations.

c Occasionally a lab recovery sample collected for a closed cab trial was analyzed in the open cab sample run as a lab recovery sample. Also, occasionally a lab recovery sample collected in the open cab trials was analyzed in the closed cab sample run and used as a lab recovery .

Field Recovery Urine Samples Four trials in the closed cab study and 4 trials in the open cab study included   spiked  fortification urine samples. These included one control, three low fortification ( 0.50 ng/ mL) and three high fortification ( 10 ng/ mL) samples. These samples were stored in a laboratory freezer and upon collection of the day 1 samples, the field fortification samples were transferred to the refrigerator used for storing the urine during collection. The fortification samples were returned to freezer storage after aliquots were removed from the final urine sample. For the open cab trials, overall percent recoveries ranged from 82% to 91% and for the closed cab trials, ranged from 79% to 97%.

Table 5. Urine Sample Field Fortification Recoveries      11    39 Trial Number Fortification Level Fortified ( ng/ mL) Measured residue ( ng/ mL) Blank Sample Residue ( ng/ mL) Corrected residuea ( ng/ mL) Percent recovery (%) Average Percent Recovery (%) Overall Average Percent Recovery (%)

Open cabs ( Trials GU020 03D through GU034 02D)

0.409 0 0.409 82 0.406 0 0.406 81 Low 0.5 0.39 0 0.39 78 80 9.762 0 9.762 98 9.329 0 9.329 93 GU020 03D High 10 8.522 0 8.522 85 92 86 4.065 0.01 4.055 811 4.15 0.01 4.140 828 Lowb 0.5 3.869 0.01 3.859 772 804 ( excluded from the data set)

7.602 0.01 7.592 76 8.106 0.01 8.096 81 GU024 03D High 10 8.009 0.01 7.999 80 79 79 0.52 0.002 0.518 104 0.464 0.002 0.462 92 Low 0.5 0.499 0.002 0.497 99 98 7.773 0.002 7.771 78 9.356 0.002 9.354 94 GU045 03D High 10 7.975 0.002 7.973 80 84 91 0.399 0.008 0.391 78 0.397 0.008 0.389 78 Low 0.5 0.432 0.008 0.424 85 80 8.704 0.008 8.696 87 8.735 0.008 8.727 87 GU027 03D High 10 7.895 0.008 7.887 79 84 82 0.500 0.023 0.477 95 0.458 0.023 0.435 87 Low 0.5 0.461 0.023 0.438 88 90 7.787 0.023 7.764 78 8.326 0.023 8.303 83 GU031 03D High 10 9.585 0.023 9.562 96c 85 88 Closed cabs ( Trials GU035 03D through GU049 03D)

0.517 0.152 0.365 73 0.526 0.152 0.374 75 Low 0.5 0.566 0.152 0.414 83 77 8.596 0.152 8.444 84 8.024 0.152 7.872 79 GU035 03D High 10 7.916 0.152 7.764 78 80 79 0.664 0.132 0.532 106 0.549 0.132 0.417 83 GU040 03D Low 0.5 90 87      12    39 Table 5. Urine Sample Field Fortification Recoveries Trial Number Fortification Level Fortified ( ng/ mL) Measured residue ( ng/ mL) Blank Sample Residue ( ng/ mL) Corrected residuea ( ng/ mL) Percent recovery (%) Average Percent Recovery (%) Overall Average Percent Recovery (%)

0.534 0.132 0.402 80 7.832 0.132 7.700 77 8.689 0.132 8.557 86 High 10 9.224 0.132 9.092 91 84 0.520 0.002 0.518 104 0.464 0.002 0.462 92 Low 0.5 0.499 0.002 0.497 99 98 7.773 0.002 7.771 78 9.356 0.002 9.354 94 GU045 03D High 10 7.975 0.002 7.973 80 84 91 0.409 0 0.409 82 0.406 0 0.406 81 Low 0.5 0.390 0 0.39 78 80 9.762 0 9.762 98 9.329 0 9.329 93 GU020 03D High 10 8.522 0 8.522 85 92 86 0.567 0.027 0.540 108 0.528 0.027 0.501 100 Low 0.5 0.517 0.027 0.490 98 102 9.557 0.027 9.530 95 9.363 0.027 9.336 93 GU048 03D High 10 8.567 0.027 8.54 85 91 97 a Corrected residue is the measured residue minus the average blank residue.

b Not used since study report states that samples were misfortified c In raw data, this sample is listed as GU027 03D; but it is assumed that this is a typo Breathing Zone Air Samples Four trials in the closed cab study and 4 trials in the open cab study included   spiked  fortification samples, two at the low fortification ( 500 ng) level and two at the high fortification ( 10,000 ng) level. Air was drawn through the fortified tubes during a period equivalent to the azinphos methyl exposure at the flow rate used for the study. Table 6 provides the field fortification recoveries for the OVS tubes. For the open cab trials, AZM overall average field fortification recoveries ranged from 80% to 93% and AZM oxon overall average field fortification recoveries ranged from 88% to 99%. For the closed cab trials, AZM overall average field fortification recoveries ranged from 80% to 9% and AZM oxon overall average field fortification recoveries ranged from 81% to 99%.

Table6. OVS Tubes Field Fortification Recoveries      13    39 Trial Number Fortification Level ( ng) Measured Bottom Residue ( ng) Bottom Blank Residues ( ng) Corrected Bottom Residuea ( ng) Measured Top Residue ( ng) Top Blank Residues ( ng) Corrected Top Residuea ( ng) Total Residue ( top + bottom) ( ng) Percent recovery (%) Average Percent Recovery (%) Overall Average Recovery (%)

Open cabs ( Trials GU020 03D through GU034 02D)

AZMb 6.5 6.3 < LODc 442.1 8.5 433.6 436.1 87 500 < LOD 6.3 < LOD 434.2 8.5 425.7 428.2 86 86 8.3 6.3 < LOD 8841.7 8.5 8833.2 8835.7 88 GU020 03D 10000 8.8 6.3 < LOD 10104.5 8.5 10096 10098.5 101 95 91 < LOD 2.5 < LOD 508 18.7 489.3 491.8 98 500 < LOD 2.5 < LOD 503.2 18.7 484.5 487 97 98 16.3 2.5 13.8 8864.9 18.7 8846.2 8860 89 GU031 03D 10000 17.8 2.5 15.3 8787.1 18.7 8768.4 8783.7 88 88 93 < LOD 2.5 < LOD 366.7 14.5 352.2 354.7 71 500 < LOD 2.5 < LOD 373.8 14.5 359.3 361.8 72 72 < LOD 2.5 < LOD 9069.6 14.5 9055.1 9057.6 91 GU045 03D 10000 < LOD 2.5 < LOD 8642 14.5 8627.5 8630 86 88 80 25.4 27.3 < LOD 368.4 14.1 354.3 356.8 71 500 23.4 27.3 < LOD 363.9 14.1 349.8 352.3 70 71 57.5 27.3 30.2 9478.8 14.1 9464.7 9494.9 95 GU024 03D 10000 28.1 27.3 < LOD 9096.7 14.1 9082.6 9085.1 91 93 82 6.4 5.4 < LOD 486.4 16.5 469.9 472.4 94 500 5.3 5.4 < LOD 538.2 16.5 521.7 524.2 105 100 19.7 5.4 14.3 8343.5 16.5 8327 8341.3 83 GU027 03D 10000 5.6 5.4 < LOD 8249.9 16.5 8233.4 8235.9 82 83 91 AZM oxond < LOD < LOD < LOD 533.9 < LOD 529.4 533.9 107 500 < LOD < LOD < LOD 518.4 < LOD 513.9 518.4 104 105 < LOD < LOD < LOD 9016.8 < LOD 9012.3 9016.8 90 GU020 03D 10000 < LOD < LOD < LOD 9374.6 < LOD 9370.1 9374.6 94 92 99 < LOD < LOD < LOD 465.3 < LOD 460.8 465.3 93 500 < LOD < LOD < LOD 468.8 < LOD 464.3 468.8 94 93 13.9 9.4 9.4 9135.8 < LOD 9131.3 9140.7 91 GU031 03D 10000 12.5 < LOD < LOD 8822.8 < LOD 8818.3 8822.8 88 90 92 < LOD < LOD < LOD 503.3 < LOD 498.8 503.3 101 500 < LOD < LOD < LOD 538.7 < LOD 534.2 538.7 108 104 < LOD < LOD < LOD 8479.6 < LOD 8475.1 8479.6 85 GU045 03D 10000 < LOD < LOD < LOD 8160 < LOD 8155.5 8160 82 83 94 < LOD < LOD < LOD 411.8 < LOD 407.3 411.8 82 GU024 03D 500 < LOD < LOD < LOD 402.3 < LOD 397.8 402.3 80 81 88      14    39 Table6. OVS Tubes Field Fortification Recoveries Trial Number Fortification Level ( ng) Measured Bottom Residue ( ng) Bottom Blank Residues ( ng) Corrected Bottom Residuea ( ng) Measured Top Residue ( ng) Top Blank Residues ( ng) Corrected Top Residuea ( ng) Total Residue ( top + bottom) ( ng) Percent recovery (%) Average Percent Recovery (%) Overall Average Recovery (%)

< LOD < LOD < LOD 9440.2 < LOD 9435.7 9440.2 94 10000 < LOD < LOD < LOD 9348.3 < LOD 9343.8 9348.3 93 94 < LOD < LOD < LOD 466.8 < LOD 462.3 466.8 93 500 < LOD < LOD < LOD 513.8 < LOD 509.3 513.8 103 98 12.8 < LOD < LOD 8955.2 < LOD 8950.7 8955.2 90 GU027 03D 10000 < LOD < LOD < LOD 8202.3 < LOD 8197.8 8202.3 82 86 92 Closed cabs ( Trials GU035 03D through GU049 03D)

AZM 6.5 6.3 < LOD 442.1 8.5 433.6 436.1 87 500 < LOD 6.3 < LOD 434.2 8.5 425.7 428.2 86 86 8.3 6.3 < LOD 8841.7 8.5 8833.2 8835.7 88 GU020 03D 10000 8.8 6.3 < LOD 10104.5 8.5 10096 10098.5 101 95 91 5 < LOD < LOD 501.7 18.7 483 485.5 97 500 7.7 < LOD 5.2 365.9 18.7 347.2 352.4 70 84 6 < LOD < LOD 8639.4 18.7 8620.7 8623.2 86 GU048 03D 10000 < LOD < LOD < LOD 8637.6 18.7 8618.9 8621.4 86 86 85 < LOD < LOD < LOD 366.7 14.5 352.2 354.7 71 500 < LOD < LOD < LOD 373.8 14.5 359.3 361.8 72 72 < LOD < LOD < LOD 9069.6 14.5 9055.1 9057.6 91 GU045 03D 10000 < LOD < LOD < LOD 8642 14.5 8627.5 8630 86 88 80 < LOD < LOD < LOD 487.7 < LOD 485.2 487.7 98 < LOD < LOD < LOD 476.6 < LOD 474.1 476.6 95 < LOD < LOD < LOD 496.6 < LOD 494.1 496.6 99 500 < LOD < LOD < LOD 506.5 < LOD 504 506.5 101 98 18.2 < LOD 15.7 9636.9 < LOD 9634.4 9650.1 97 17.3 < LOD 14.8 9743.3 < LOD 9740.8 9755.6 98 13 < LOD 10.5 10187.2 < LOD 10184.7 10195.2 102 GU035 03D& G U040 03D 10000 6.9 < LOD < LOD 9897.1 < LOD 9894.6 9897.1 99 99 99 AZM oxon < LOD < LOD < LOD 533.9 < LOD 529.4 533.9 107 500 < LOD < LOD < LOD 518.4 < LOD 513.9 518.4 104 105 < LOD < LOD < LOD 9016.8 < LOD 9012.3 9016.8 90 GU020 03D 10000 < LOD < LOD < LOD 9374.6 < LOD 9370.1 9374.6 94 92 99 < LOD < LOD < LOD 437.3 < LOD 432.8 437.3 87 500 < LOD < LOD < LOD 326.9 < LOD 322.4 326.9 65 76 GU048 03D 81      15    39 Table6. OVS Tubes Field Fortification Recoveries Trial Number Fortification Level ( ng) Measured Bottom Residue ( ng) Bottom Blank Residues ( ng) Corrected Bottom Residuea ( ng) Measured Top Residue ( ng) Top Blank Residues ( ng) Corrected Top Residuea ( ng) Total Residue ( top + bottom) ( ng) Percent recovery (%) Average Percent Recovery (%) Overall Average Recovery (%)

< LOD < LOD < LOD 8599.2 < LOD 8594.7 8599.2 86 10000 < LOD < LOD < LOD 8674.4 < LOD 8669.9 8674.4 87 86 < LOD < LOD < LOD 503.3 < LOD 498.8 503.3 101 500 < LOD < LOD < LOD 538.7 < LOD 534.2 538.7 108 104 < LOD < LOD < LOD 8479.6 < LOD 8475.1 8479.6 85 GU045 03D 10000 < LOD < LOD < LOD 8160 < LOD 8155.5 8160 82 83 94 < LOD < LOD < LOD 496.6 < LOD 492.1 496.6 99 < LOD < LOD < LOD 500.3 < LOD 495.8 500.3 100 < LOD < LOD < LOD 494.9 < LOD 490.4 494.9 99 500 < LOD < LOD < LOD 502.9 < LOD 498.4 502.9 101 100 15.5 < LOD 11 9959.1 < LOD 9954.6 9965.6 100 16.5 < LOD 12 9706.5 < LOD 9702 9714 97 10.6 < LOD < LOD 9671.7 < LOD 9667.2 9671.7 97 GU035 03D& G U040 03D 10000 < LOD < LOD < LOD 9113.8 < LOD 9109.3 9113.8 91 96 98 a Corrected residue is the measured residue minus the average blank residue.

b AZM = azinphos methylc For values less than the LOD, ½ the LOD was used in subsequent calculations. For AZM ½ LOD = 2.5 ng and for AZM oxon ½ LOD = 4.5 ng d AZM oxon = azinphos methyl oxon      16    39 Tank mix: No information on tank mix analysis was provided in the Study Report. Travel Recovery: Travel recovery was not assessed in the Study Report. Storage Stability: All samples were stored frozen prior to analysis. Urine samples were held for a maximum of 30 days prior to extraction and all extracts were analyzed within 15 days after extraction. OVS tube samples were held for a maximum of 152 days prior to extraction and all extracts were analyzed within 2 days after extraction. The Study Report states that the acceptable recoveries from the field fortification samples indicates that the field samples would be stable over the period of collection, storage, and shipping through sample analysis. A separate storage stability study was not performed.

II. RESULTS AND CALCULATIONS:

A. EXPOSURE CALCULATIONS:

Internal Dose The internal azinphos methyl dose was determined from the urinary biomarker, MSMB, residues measured in 24 hour urine samples collected from each worker during a sampling interval of 120 hours following initiation of exposure. MSMB residue levels are presented in this report as µ g equivalents of parent azinphos methyl. Equivalents were calculated using a molecular weight conversion factor of 1.328. The MSMB residues measured in the urine samples following entry are presented both with a correction for the amount of MSMB residue found in each worker s urine sample from the day before entry ( day  1, assumed to be a background concentration) and without this correction. HED also corrected field fortification samples for blank sample residues and corrected all field samples for field fortification recoveries, even those greater than 90% per EPA s request. Corrected residue was then adjusted for the volume of urine collected during each 24 hour sampling interval. The MSMB residue levels excreted for each worker over the entire post entry sampling interval ( 120 hours following initiation of exposure) were summed ( i. e., day 0, day 1, day 2, day 3, and day 4). HED adjusted the summed MSMB excreted for each worker for the cumulative percent of the absorbed dose excreted 96 120 hours after exposure ( determined from a previous study   83.6%) and the percent of urine activity attributed to MSMB ( determined from a previous study   9.2%). These results were then normalized to body weight and amount of active ingredient handled. Table 7 provides the average azinphos methyl doses for open and closed cab field trials based on body weight and pounds of active ingredient handled. Doses were calculated both by correcting for background residues and not correcting for background residues ( day  1 residues). The average azinphos methyl doses for open cab and closed cab field trials, without background correction, are 0.0035 and 0.00080 mg/ kg body weight, respectively. The total average azinphos methyl doses for open cab and closed cab field trials, with background correction, are 0.0027 and 0.00057 mg/ kg body weight, respectively. Azinphos methyl doses for open and closed cab field trials, based on pounds active ingredient handled, are 0.013 and 0.0023 mg/ lb ai handled ( without background correction) and 0.0095 and 0.0017 mg/ lb ai handled ( with background correction). Tables 8 and 9 provide individual azinphos methyl doses for each field trial, both corrected for background residues and not corrected for background residues.      17    39 Breathing Zone Air Samples Potential inhalation exposure was determined through the use of OVS sampling tubes and is presented in Table 10. Residues of both azinphos methyl and azinphos methyl oxon were measured on the top and bottom portions of the sampling tubes and combined for a total azinphos methyl residue. Average potential inhalation exposures for open cab trials were calculated to be 166.8 µ g or 4.0 µ g/ lb ai handled and average exposures for enclosed cab trials were calculated to be 14.7 µ g or 0.2 µ g/ lb ai handled. The inhalation exposure concentration for mixer/ loader/ applicators using open cab tractor drawn airblast equipment ranged from 8.79 to 40.03 µ g/ m3 and averaged 24.5 µ g/ m3. For mixer/ loader/ applicators using enclosed cab tractor drawn airblast equipment concentration levels ranged from 0.37 to 5.03 µ g/ m3 and averaged 1.9 µ g/ m3.

III DISCUSSION:

A. LIMITATIONS OF THE STUDY: This study met most of the Group A 875.1300 ( inhalation exposure) and 875.1500 ( biological monitoring) Guidelines. The major issues of concern are:

  The guideline states that a sufficient number of replicates should be generated to address the exposure issues associated with the population of interest. The open cab study began with 15 replicates, however, results from three of the workers were excluded from the data analysis due to unusually high background ( day  1) residue levels.

· The guideline states that samples should be stored in a manner that will minimize deterioration and loss of analytes between collection and analysis; biological monitoring samples ( e. g., serum, plasma and urine) should be refrigerated or stored frozen prior to analysis ; whole blood should not be frozen; and information on storage stability should be provided. The Study Report states that samples were stored frozen prior to analysis and that field fortification samples and recoveries were used to demonstrate storage stability. A separate storage stability study was not mentioned.

· According to active AZM label, the maximum application rate recommended for apples is 1.5 lb ai/ acre. The actual application rates for the open cab trials averaged 0.911 lb ai/ A ( ranging from 0.534 lb ai/ A to 1.098 lb ai/ A and for the closed cab trials averaged 1.407 lb ai/ A ( ranging from 0.62 lb ai/ A to 2.052 lb ai/ A).

· The guideline states that data should be corrected if any appropriate field fortified, laboratory fortified or storage stability recovery is less than 90 percent. This criterion was altered and the Study Report states that corrections were made for all field fortification recovery values, even those above 90%.

· The guideline states that a trapping efficiency test for the monitoring media chosen must be documented. A trapping efficiency test was not reported. However, average method validation recoveries ranged from 90% to 107% for azinphos methyl and from 86% to 102% for azinphos methyl oxon.      18    39 · The guideline states that air samples should also be tested for breakthrough to ensure that collected material is not lost from the medium during sampling and it is recommended that at least one test be carried out where the initial trap contains 10X the highest amount of residue expected in the field. A breakthrough test was not mentioned in the Study Report.

· The guideline states that the extraction efficiency of laboratory fortified controls is considered acceptable if the lower limit of the 95% confidence interval is greater than 75%, unless otherwise specified by the Agency. At a minimum, the guideline states that seven determinations should be made at each fortification level to calculate the mean and standard deviation for recovery and that the total recovery from field fortified samples must be greater than 50% for the study. Laboratory control samples were fortified and yielded average recoveries of 101% for azinphos methyl and 97% for azinphos methyl oxon for the open cab field trials and 103% for azinphos methyl and 95% for azinphos methyl oxon for the closed cab field trials. There were 5 fortification samples at 2 levels, with all recoveries greater than 50%.

· The guideline states that if trapping media or extracts from field samples are to be stored after exposure, a stability test of the compound of interest must be documented and the media must be stored under the same conditions as field samples. Storage stability samples should be extracted and analyzed immediately before and at appropriate periods during storage and the time periods for storage should be chosen so that the longest corresponds to the longest projected storage period for field samples. There was no information in storage stability included in the study report.

· Rainfall from the first application to the last sampling was the only meteorological condition reported by the registrant.

Additionally other major issues of concern were noted in evaluation of the study:

· The Registrant presented results in terms of the quantity of azinphos methyl equivalent excreted at each 24 hour sampling interval. This calculation does not correlate to the total dose received after one day s exposure to azinphos methyl. The estimated dose received after one day of exposure is calculated by adding the daily amount excreted over the 120 hour collection period and factoring for azinphos methyl dose expected to be excreted in urine 120 hours after exposure and the percentage of azinphos methyl dose represented by MSMB.

· The Registrant used an inappropriate adjustment factor to normalize measured azinphos methyl equivalents to correspond to an estimated azinphos methyl dose. The authors used the adjustment factor appropriate for a collection over 192 hours ( not the 120 hour collection used in the study). The value used by the study authors was 8.2% representing 89.3% of the absorbed dose excreted over 120 192 hours. Urine samples were collected for 120 hours after entry. The registrant also used this correction factor for each 24 hour urine sampling period beginning with the first 24 hours after entry ( day 0). In order to estimate the total absorbed dose of AZM based on 120 hour MSMB residue levels, the appropriate correction value is 9.2% representing 83.6% of the absorbed dose      19    39 excreted in urine over 120 hours. The calculation also requires the addition of residue values from all five sampling intervals ( i. e., day 0, day 1, day 2, day 3, and day 4).

· Registrant inhalation exposure estimates are based on a breathing rate of 29 L/ min. HED inhalation exposure estimates are based on the NAFTA recommended breathing rate of 16.7 L/ min for light activities.

· HED is concerned about the methodology used to   adjust  day 0 through day 4 AZM doses by subtracting out the AZM dose measured on the day before exposure   called   background AZM  in the study. In most of replicates in the other studies and in the enclosed cab portion of this study, the background AZM is at or near the LOD. However, only three of the replicates in the open cab portion of this study had background levels less than LOD. In the rest of the open cab replicates, the   background  levels are higher than the LOD   in some cases substantially higher  and clearly impact the resulting AZM doses. Since there is a high degree of uncertainty about the pre study AZM exposures experienced by the handlers in this study   there are five study deviations where handlers did not have the minimum 14 day no exposure period and three instances where handler replicates were thrown out due to unusually high   background  levels of AZM   the more protective approach might be to not adjust for   background  AZM levels.

· The personal protective equipment worn by handlers in the open cab replicates   particularly the chemical resistant suits and negative pressure respirators   presents a heat and respiratory stress concern. The Office of Pesticide Programs  Guide to Heat Stress in Agriculture indicates that persons doing light work in chemical resistant attire should work only 30 minutes out of each hour if the temperature is 80 degrees and there is full sun. The work cycle diminishes to 15 minutes at 85 degrees and full sun and at 90 degrees and full sun, it indicates a very high risk of heat related illness and recommends stopping work. Since the Worker Protection Standard for Agricultural Pesticides requires employers to   take any necessary steps to prevent heat illness while PPE is being worn,  and removed all requirements for chemical resistant suits from pesticide labels for routine handling tasks, this would appear to make the use of chemical resistant suits for routine airblast applications in open cabs impractical, if not impossible, during the summer months when most AZM orchard applications take place.

· In the open cab replicates, there are five deviations ( for replicates 22, 23, 24, 25, and 26) indicating that the handlers in those replicates did not have the minimum 14 day period ( prior to testing) in which the volunteer was not to have been exposed to AZM. Instead, various AZM free exposure days are reported   ranging from seven exposure free days for replicate 22 to ten exposure free days for replicates 25 and 26. After the data were analyzed, the study authors reported that three of the open cab handlers ( replicates 22, 28, and 33) had   obvious exposure to AZM  prior to the study onset and the authors did not include data from these three replicates in when they analyzed/ summarized the open cab replicate results. No explanation is given as to why replicates 28 and 33 might have high background levels of AZM. Also, by throwing out the three replicates, the open cab portion of the study has only 12 remaining replicates.      20    39 · In the open cab replicates, handlers wore two distinct types of PPE. Replicates 20 through 26 ( minus 22, which was not used) wore uncoated Tyvek coveralls over long sleeve shirt and long pants and some type of chemical resistant headgear, whereas replicates 27 through 34 ( minus 28 and 33, which were not used) wore over their long sleeve shirt and long pants either a two piece hooded rubber rainsuit or a one piece hooded PVC coated coverall. Since these are two different levels of personal protective equipment   double layer body protection for the uncoated Tyvek versus chemical resistant suit for the rainsuit and coated Tyvek, these data probably should be analyzed and summarized separately.

· In the enclosed cab replicates ( replicates 35 through 49), all of the cabs are listed as having charcoal filtration systems, except replicates 45, 46, 47, and 49. However, since handlers in the enclosed cabs that did not list charcoal filtration systems were apparently not wearing respirators, it is possible that all the enclosed cabs had charcoal filtration systems. Enclosed cabs with charcoal filtration systems are quite sophisticated and expensive and provide both dermal and inhalation protection. The inexpensive type of enclosed cab provides dermal protection only. HED notes that the enclosed cabs were used without apparent difficulty in apple orchards   even orchards containing the smaller hybrid trees.

Table 7. Azinphos methyl Doses For Open and Closed Cab Field Trials by Body Weight and by Pounds Active Ingredient Handled Open Cab Field Trials Closed Cab Field Trials Arithmetic Mean Geometric Mean Standard Deviation Arithmetic Mean Geometric Mean Standard Deviation Not corrected for background residues mg/ kg body weight 0.0035 0.0029 0.0019 0.00080 0.00056 0.00070 mg/ lb ai handled 0.013 0.010 0.0092 0.0023 0.0016 0.0021 Corrected for background residues mg/ kg body weight 0.0027 0.0021 0.0016 0.00057 0.00034 0.00053 mg/ lb ai handled 0.0095 0.0075 0.0060 0.0017 0.0010 0.0019      21    39 Table 8. Azinphos methyl Internal Dose ( Not corrected for background residues)

Sample Number Sampling Interval MSMB excreteda( µ g) Total MSMB excreteda( µ g) % of absorbed dose excreted in urine after 120 hours % of total AZM dose represented by MSMB Total AZM Doseb ( µ g) Body weight ( kg) Total AZM Dosec ( mg/ kg BW) Lb ai Handled Total AZM Dosed ( mg/ lb ai handled)

OPEN CABS  1 0 2.168 1 4.727 2 3.913 3 1.624 GU020 03D 4 1.099 13.530 83.6 9.2 176 91 0.0019 35 0.0050  1 0 13.031 1 9.167 2 9.820 3 5.040 GU021 03D 4 2.695 39.754 83.6 9.2 517 95 0.0054 63 0.0082  1 0 6.649 1 3.699 2 8.290 3 10.477 GU022 03D 4 3.403 Study noted that sample had high background; was not included in data analysis.

 1 0 15.334 1 9.059 2 4.303 3 2.830 GU023 03D 4 1.439 32.965 83.6 9.2 429 84 0.0051 33 0.013      22    39 Table 8. Azinphos methyl Internal Dose ( Not corrected for background residues)

Sample Number Sampling Interval MSMB excreteda( µ g) Total MSMB excreteda( µ g) % of absorbed dose excreted in urine after 120 hours % of total AZM dose represented by MSMB Total AZM Doseb ( µ g) Body weight ( kg) Total AZM Dosec ( mg/ kg BW) Lb ai Handled Total AZM Dosed ( mg/ lb ai handled)

 1 0 12.021 1 11.780 2 7.985 3 5.692 GU024 03D 4 4.165 41.643 83.6 9.2 541 98 0.0055 16 0.034  1 0 10.589 1 8.838 2 2.135 3 0.414 GU025 03D 4 0.801 22.777 83.6 9.2 296 66 0.0045 22 0.013  1 0 1.659 1 2.496 2 1.162 3 0.587 GU026 03D 4 0.306 6.210 83.6 9.2 81 78 0.0010 8 0.010  1 0 4.469 1 5.049 2 3.151 3 2.723 GU027 03D 4 1.766 17.157 83.6 9.2 223 86 0.0026 24 0.0093  1 GU028 03D Study noted that sample had high background; was not included in data analysis.      23    39 Table 8. Azinphos methyl Internal Dose ( Not corrected for background residues)

Sample Number Sampling Interval MSMB excreteda( µ g) Total MSMB excreteda( µ g) % of absorbed dose excreted in urine after 120 hours % of total AZM dose represented by MSMB Total AZM Doseb ( µ g) Body weight ( kg) Total AZM Dosec ( mg/ kg BW) Lb ai Handled Total AZM Dosed ( mg/ lb ai handled)

0 46.222 1 23.713 2 36.448 3 35.335 4 23.019  1 0 2.750 1 2.696 2 1.770 3 0.988 GU029 03D 4 0.433 8.637 83.6 9.2 112 70 0.0016 20 0.0056  1 0 5.519 1 9.346 2 2.676 3 1.550 GU030 03D 4 1.526 20.617 83.6 9.2 268 75 0.0036 20 0.013  3  2  1 0 7.392 1 15.022 2 11.241 3 3.513 GU031 03D 4 2.075 39.244 83.6 9.2 510 86 0.0059 20 0.026      24    39 Table 8. Azinphos methyl Internal Dose ( Not corrected for background residues)

Sample Number Sampling Interval MSMB excreteda( µ g) Total MSMB excreteda( µ g) % of absorbed dose excreted in urine after 120 hours % of total AZM dose represented by MSMB Total AZM Doseb ( µ g) Body weight ( kg) Total AZM Dosec ( mg/ kg BW) Lb ai Handled Total AZM Dosed ( mg/ lb ai handled)

 1 0 7.099 1 11.507 2 6.489 3 4.280 GU032 03D 4 1.787 31.163 83.6 9.2 405 84 0.0048 20 0.020  3  2  1 0 33.306 1 21.906 2 15.092 3 8.272 GU033 03D 4 5.666 Study noted that sample had high background; was not included in data analysis.

 3  2  1 0 0.326 1 1.318 2 0.436 3 0.240 GU034 03D 4 0.731 3.051 83.6 9.2 40 75 0.00053 20 0.0020 CLOSED CABS  1 0 0.094 GU035 03D 1.314 83.6 9.2 17 108 0.00016 24 0.00071      25    39 Table 8. Azinphos methyl Internal Dose ( Not corrected for background residues)

Sample Number Sampling Interval MSMB excreteda( µ g) Total MSMB excreteda( µ g) % of absorbed dose excreted in urine after 120 hours % of total AZM dose represented by MSMB Total AZM Doseb ( µ g) Body weight ( kg) Total AZM Dosec ( mg/ kg BW) Lb ai Handled Total AZM Dosed ( mg/ lb ai handled)

1 0.427 2 0.423 3 0.269 4 0.101  1 0 0.925 1 2.631 2 3.303 3 2.750 GU036 03D 4 3.354 12.964 83.6 9.2 169 91 0.0019 22 0.0075  1 0 0.457 1 2.495 2 2.188 3 1.416 GU037 03D 4 0.824 7.380 83.6 9.2 96 102 0.00094 37 0.0026  1 0 0.422 1 0.539 2 0.273 3 0.170 GU038 03D 4 0.135 1.540 83.6 9.2 20 91 0.00022 37 0.0005  1 0 0.269 1 0.571 GU039 03D 2.272 83.6 9.2 30 71 0.00042 25 0.0012      26    39 Table 8. Azinphos methyl Internal Dose ( Not corrected for background residues)

Sample Number Sampling Interval MSMB excreteda( µ g) Total MSMB excreteda( µ g) % of absorbed dose excreted in urine after 120 hours % of total AZM dose represented by MSMB Total AZM Doseb ( µ g) Body weight ( kg) Total AZM Dosec ( mg/ kg BW) Lb ai Handled Total AZM Dosed ( mg/ lb ai handled)

2 0.581 3 0.481 4 0.371  1 0 0.903 1 1.259 2 1.667 3 0.885 GU040 03D 4 0.904 5.618 83.6 9.2 73 116 0.00063 30 0.0024  1 0 1.295 1 1.682 2 2.208 3 1.357 GU041 03D 4 0.959 7.501 83.6 9.2 98 73 0.0013 36 0.0027  1 0 0.379 1 0.478 2 0.350 3 0.133 GU042 03D 4 0.427 1.766 83.6 9.2 23 80 0.00029 45 0.00051  1 0 0.364 1 0.275 2 0.454 GU043 03D 1.521 83.6 9.2 20 77 0.00026 32 0.00061      27    39 Table 8. Azinphos methyl Internal Dose ( Not corrected for background residues)

Sample Number Sampling Interval MSMB excreteda( µ g) Total MSMB excreteda( µ g) % of absorbed dose excreted in urine after 120 hours % of total AZM dose represented by MSMB Total AZM Doseb ( µ g) Body weight ( kg) Total AZM Dosec ( mg/ kg BW) Lb ai Handled Total AZM Dosed ( mg/ lb ai handled)

3 0.181 4 0.247  1 0 0.645 1 1.003 2 1.031 3 0.960 GU044 03D 4 0.743 4.382 83.6 9.2 57 98 0.00058 40 0.0014  1 0 0.090 1 0.384 2 0.246 3 0.211 GU045 03D 4 0.094 1.025 83.6 9.2 13 73 0.00018 20 0.00067  1 0 2.525 1 4.034 2 2.699 3 3.192 GU046 03D 4 1.667 14.116 83.6 9.2 184 95 0.0019 31 0.0059  1 0 3.456 1 2.958 2 3.092 3 2.896 GU047 03D 15.534 83.6 9.2 202 91 0.0022 52 0.0039      28    39 Table 8. Azinphos methyl Internal Dose ( Not corrected for background residues)

Sample Number Sampling Interval MSMB excreteda( µ g) Total MSMB excreteda( µ g) % of absorbed dose excreted in urine after 120 hours % of total AZM dose represented by MSMB Total AZM Doseb ( µ g) Body weight ( kg) Total AZM Dosec ( mg/ kg BW) Lb ai Handled Total AZM Dosed ( mg/ lb ai handled)

4 3.132  3  2  1 0 0.799 1 0.956 2 0.835 3 0.327 GU048 03D 4 0.203 3.121 83.6 9.2 41 70 0.00058 20 0.0020  3  2  1 0 0.286 1 0.716 2 0.566 3 0.523 GU049 03D 4 0.885 2.976 83.6 9.2 39 84 0.00046 20 0.0019 a Total MSMB excreted ( ug) =[( measured MSMB ( AZM equivalents) ng/ mL / field fortification recovery correction factor) x 24 hour urine volume ( mL)] * 1 ug/ 1000 ng. This amount was calculated for each day ( 0 4) and then summed to give a 120 hour total residue estimate. Field fortification were used correction:

For trials GUO27, GU028, GU029, GU030, GU032: 80% when residue < 2.2 ng/ mL and 84% when residue > 2.2 ng/ mL For trials GU026: 98% when residue < 2.2 ng/ mL and 84% when residue > 2.2 ng/ mL For trials GU020 and GU021: 80% when residue < 2.2 ng/ mL and 92% when residue > 2.2 ng/ mL For trials GU022, GU023, GU024, GU025: 79% when residue < 2.2 ng/ mL and 79% when residue > 2.2 ng/ mL For trials GU031, GU033, GU034: 90% when residue < 2.2 ng/ mL and 85% when residue > 2.2 ng/ mL For trials GU035, GU036, GU) 37, GU038, GU039: 77% when residue < 2.2 ng/ mL and 80% when residue > 2.2 ng/ mL For trials GU040, GU041, GU042, GU043, GU044: 90% when residue < 2.2 ng/ mL and 84.5% when residue > 2.2 ng/ mL For trials GU045: 98% when residue < 2.2 ng/ mL and 84% when residue > 2.2 ng/ mL For trials GU046, GU047: 80% when residue < 2.2 ng/ mL and 92% when residue > 2.2 ng/ mL For trials GU048, GU049: 102% when residue < 2.2 ng/ mL and 91% when residue > 2.2 ng/ mL b Total AZM Dose ( µ g) = Total MSMB excreted ( µ g) * % of absorbed dose excreted in urine after 120 hours/ 100 * % of total AZM dose represented by MSMB/ 100 c Total AZM Dose ( mg/ kg BW) = (( Total AZM Dose ( µ g)) / 1000) / Body Weight ( kg)

d Total AZM Dose ( mg/ lb ai handled) = (( Total AZM Dose ( µ g)) / 1000) / lb ai handled      29    39 Table 9. Azinphos methyl Internal Dose( Corrected for background residues)

Sample Number Sampling Interval MSMB excreteda( µ g) Total MSMB excreteda( µ g) % of absorbed dose excreted in urine after 120 hours % of total AZM dose represented by MSMB Total AZM Doseb ( µ g) Body weight ( kg) Total AZM Dosec ( mg/ kg BW) Lb ai Handled Total AZM Dosed ( mg/ lb ai handled)

OPEN CABS  1 0 1.322 1 3.434 2 2.309 3 0.688 GU020 03D 4 0.000 7.752 83.6 9.2 101 91 0.0011 35 0.0029  1 0 10.844 1 7.653 2 6.371 3 1.591 GU021 03D 4 0.592 27.051 83.6 9.2 352 95 0.0037 63 0.0055  1 0 1 2 3 GU022 03D 4 Study noted that sample had high background; was not included in data analysis.

 1 0 14.446 1 8.447 2 3.849 3 2.258 GU023 03D 4 0.847 29.845 83.6 9.2 388 84 0.0046 33 0.012      30    39 Table 9. Azinphos methyl Internal Dose( Corrected for background residues)

Sample Number Sampling Interval MSMB excreteda( µ g) Total MSMB excreteda( µ g) % of absorbed dose excreted in urine after 120 hours % of total AZM dose represented by MSMB Total AZM Doseb ( µ g) Body weight ( kg) Total AZM Dosec ( mg/ kg BW) Lb ai Handled Total AZM Dosed ( mg/ lb ai handled)

 1 0 6.899 1 5.839 2 1.634 3 0.000 GU024 03D 4 0.000 14.372 83.6 9.2 187 98 0.0019 16 0.012  1 0 9.853 1 8.335 2 1.834 3 0.247 GU025 03D 4 0.299 20.568 83.6 9.2 267 66 0.0041 22 0.012  1 0 0.910 1 1.118 2 0.177 3 0.000 GU026 03D 4 0.000 2.205 83.6 9.2 29 78 0.00037 8 0.0034  1 0 4.383 1 4.988 2 3.071 3 2.591 GU027 03D 4 1.627 16.659 83.6 9.2 217 86 0.0025 24 0.0090  1 GU028 03D Study noted that sample had high background; was not included in data analysis.      31    39 Table 9. Azinphos methyl Internal Dose( Corrected for background residues)

Sample Number Sampling Interval MSMB excreteda( µ g) Total MSMB excreteda( µ g) % of absorbed dose excreted in urine after 120 hours % of total AZM dose represented by MSMB Total AZM Doseb ( µ g) Body weight ( kg) Total AZM Dosec ( mg/ kg BW) Lb ai Handled Total AZM Dosed ( mg/ lb ai handled)

0 1 2 3 4  1 0 2.648 1 2.628 2 1.678 3 0.878 GU029 03D 4 0.352 8.183 83.6 9.2 106 70 0.0015 20 0.0053  1 0 5.332 1 9.106 2 2.543 3 1.398 GU030 03D 4 1.241 19.620 83.6 9.2 255 75 0.0034 20 0.013  3  2  1 0 6.533 1 14.191 2 10.038 3 2.367 GU031 03D 4 1.273 34.402 83.6 9.2 447 86 0.0052 20 0.022      32    39 Table 9. Azinphos methyl Internal Dose( Corrected for background residues)

Sample Number Sampling Interval MSMB excreteda( µ g) Total MSMB excreteda( µ g) % of absorbed dose excreted in urine after 120 hours % of total AZM dose represented by MSMB Total AZM Doseb ( µ g) Body weight ( kg) Total AZM Dosec ( mg/ kg BW) Lb ai Handled Total AZM Dosed ( mg/ lb ai handled)

 1 0 5.455 1 10.364 2 4.703 3 2.279 GU032 03D 4 0.000 22.801 83.6 9.2 296 84 0.0035 20 0.015  3  2  1 0 1 2 3 GU033 03D 4 Study noted that sample had high background; was not included in data analysis.

 3  2  1 0 0.224 1 1.199 2 0.354 3 0.191 GU034 03D 4 0.649 2.617 83.6 9.2 34 75 0.00045 20 0.0017 CLOSED CABS  1 0.000 0 0.000 GU035 03D 0.866 83.6 9.2 11 108 0.00010 24 0.00047      33    39 Table 9. Azinphos methyl Internal Dose( Corrected for background residues)

Sample Number Sampling Interval MSMB excreteda( µ g) Total MSMB excreteda( µ g) % of absorbed dose excreted in urine after 120 hours % of total AZM dose represented by MSMB Total AZM Doseb ( µ g) Body weight ( kg) Total AZM Dosec ( mg/ kg BW) Lb ai Handled Total AZM Dosed ( mg/ lb ai handled)

1 0.356 2 0.322 3 0.188 4 0.000  1 0 0.834 1 2.535 2 3.222 3 2.659 GU036 03D 4 3.253 12.503 83.6 9.2 163 91 0.0018 22 0.0072  1 0 0.376 1 2.396 2 2.077 3 1.316 GU037 03D 4 0.737 6.902 83.6 9.2 90 102 0.00088 37 0.0024  1 0 0.114 1 0.137 2 0.045 3 0.000 GU038 03D 4 0.000 0.295 83.6 9.2 4 91 0.000042 37 0.000103  1 0 0.142 1 0.434 GU039 03D 1.629 83.6 9.2 21 71 0.00030 25 0.0008      34    39 Table 9. Azinphos methyl Internal Dose( Corrected for background residues)

Sample Number Sampling Interval MSMB excreteda( µ g) Total MSMB excreteda( µ g) % of absorbed dose excreted in urine after 120 hours % of total AZM dose represented by MSMB Total AZM Doseb ( µ g) Body weight ( kg) Total AZM Dosec ( mg/ kg BW) Lb ai Handled Total AZM Dosed ( mg/ lb ai handled)

2 0.429 3 0.334 4 0.290  1 0 0.645 1 0.983 2 1.253 3 0.557 GU040 03D 4 0.560 3.999 83.6 9.2 52 116 0.00045 30 0.0017  1 0 1.095 1 1.491 2 2.004 3 1.166 GU041 03D 4 0.761 6.516 83.6 9.2 85 73 0.0012 36 0.0024  1 0 0.272 1 0.367 2 0.234 3 0.000 GU042 03D 4 0.276 1.148 83.6 9.2 15 80 0.00019 45 0.00033  1 0 0.000 1 0.194 2 0.050 GU043 03D 0.349 83.6 9.2 5 77 0.000059 32 0.00014      35    39 Table 9. Azinphos methyl Internal Dose( Corrected for background residues)

Sample Number Sampling Interval MSMB excreteda( µ g) Total MSMB excreteda( µ g) % of absorbed dose excreted in urine after 120 hours % of total AZM dose represented by MSMB Total AZM Doseb ( µ g) Body weight ( kg) Total AZM Dosec ( mg/ kg BW) Lb ai Handled Total AZM Dosed ( mg/ lb ai handled)

3 0.073 4 0.031  1 0 0.481 1 0.812 2 0.902 3 0.827 GU044 03D 4 0.560 3.582 83.6 9.2 47 98 0.00048 40 0.0012  1 0 0.000 1 0.298 2 0.185 3 0.134 GU045 03D 4 0.000 0.617 83.6 9.2 8 73 0.00011 20 0.00040  1 0 1.700 1 3.044 2 1.775 3 2.268 GU046 03D 4 0.776 9.562 83.6 9.2 124 95 0.0013 31 0.0040  1 0 1.309 1 1.810 2 1.494 3 1.098 GU047 03D 6.745 83.6 9.2 88 91 0.0010 52 0.0017      36    39 Table 9. Azinphos methyl Internal Dose( Corrected for background residues)

Sample Number Sampling Interval MSMB excreteda( µ g) Total MSMB excreteda( µ g) % of absorbed dose excreted in urine after 120 hours % of total AZM dose represented by MSMB Total AZM Doseb ( µ g) Body weight ( kg) Total AZM Dosec ( mg/ kg BW) Lb ai Handled Total AZM Dosed ( mg/ lb ai handled)

4 1.034  3  2  1 0 0.658 1 0.794 2 0.576 3 0.111 GU048 03D 4 0.003 2.142 83.6 9.2 28 70 0.00040 20 0.0014  3  2  1 0 0.060 1 0.509 2 0.369 3 0.204 GU049 03D 4 0.566 1.708 83.6 9.2 22 84 0.00026 20 0.0011 a Total MSMB excreted ( ug) =[( measured MSMB ( AZM equivalents) ng/ mL / field fortification recovery correction factor) x 24 hour urine volume ( mL)] * 1 ug/ 1000 ng. This amount was calculated for each day ( 0 4) and then summed to give a 120 hour total residue estimate. Field fortification were used correction:

For trials GUO27, GU028, GU029, GU030, GU032: 80% when residue < 2.2 ng/ mL and 84% when residue > 2.2 ng/ mL For trials GU026: 98% when residue < 2.2 ng/ mL and 84% when residue > 2.2 ng/ mL For trials GU020 and GU021: 80% when residue < 2.2 ng/ mL and 92% when residue > 2.2 ng/ mL For trials GU022, GU023, GU024, GU025: 79% when residue < 2.2 ng/ mL and 79% when residue > 2.2 ng/ mL For trials GU031, GU033, GU034: 90% when residue < 2.2 ng/ mL and 85% when residue > 2.2 ng/ mL For trials GU035, GU036, GU) 37, GU038, GU039: 77% when residue < 2.2 ng/ mL and 80% when residue > 2.2 ng/ mL For trials GU040, GU041, GU042, GU043, GU044: 90% when residue < 2.2 ng/ mL and 84.5% when residue > 2.2 ng/ mL For trials GU045: 98% when residue < 2.2 ng/ mL and 84% when residue > 2.2 ng/ mL For trials GU046, GU047: 80% when residue < 2.2 ng/ mL and 92% when residue > 2.2 ng/ mL For trials GU048, GU049: 102% when residue < 2.2 ng/ mL and 91% when residue > 2.2 ng/ mL b Total AZM Dose ( µ g) = Total MSMB excreted ( µ g) * % of absorbed dose excreted in urine after 120 hours/ 100 * % of total AZM dose represented by MSMB/ 100 c Total AZM Dose ( mg/ kg BW) = (( Total AZM Dose ( µ g)) / 1000) / Body Weight ( kg)

d Total AZM Dose ( mg/ lb ai handled) = (( Total AZM Dose ( µ g)) / 1000) / lb ai handled      37    39 Table 10. Potential Inhalation Exposure Trial Number Total Inhalation Residuea ( ng) Flow Rate ( L/ min) NAFTA Breathing Rate ( L/ min) Potential Inhalation Exposure b ( µ g) Sampling time ( min) Concentration ( µ g/ m3) c lb ai handled Inhalation Exposure d ( µ g/ lb ai handled)

Open Cab GU020 03D 18170 2 16.7 151.7 583 15.58 69.85 2.17 GU021 03D 17346 2 16.7 144.8 715 12.13 126.73 1.14 GU022 03D 14566 2 16.7 121.6 556 13.10 69.85 1.74 GU023 03D 26846 2 16.7 224.2 649 20.68 66.86 3.35 GU024 03D 5838 2 16.7 48.7 332 8.79 31.93 1.53 GU025 03D 21916 2 16.7 183.0 290 37.79 43.91 4.17 GU026 03D 18833 2 16.7 157.3 362 26.01 16.96 9.27 GU027 03D 10496 2 16.7 87.6 427 12.29 47.94 1.83 GU028 03D NS 2 16.7 NS NS NS 31.96 NS GU029 03D 29118 2 16.7 243.1 374 38.93 39.95 6.09 GU030 03D 30984 2 16.7 258.7 387 40.03 39.95 6.48 GU031 03D 21280 2 16.7 177.7 359 29.64 39.95 4.45 GU032 03D 30024 2 16.7 250.7 364 41.24 39.95 6.28 GU033 03D 15152 2 16.7 126.5 370 20.48 39.95 3.17 GU034 03D 19178 2 16.7 160.1 356 26.94 39.95 4.01 Arithmetic Mean 166.8 24.5 4.0 Geometric Mean 153.9 21.9 3.3 Standard Deviation 61.8 11.5 2.0 Enclosed Cab GU035 03D 689 2 16.7 5.8 468 0.74 47.94 0.12 GU036 03D 1122 2 16.7 9.4 440 1.27 44.95 0.21 GU037 03D 1674 2 16.7 14.0 590 1.42 74.91 0.19 GU038 03D 786 2 16.7 6.6 498 0.79 74.91 0.09 GU039 03D 2876 2 16.7 24.0 506 2.84 49.94 0.48 GU040 03D 4200 2 16.7 35.1 491 4.28 59.93 0.59 GU041 03D 1875 2 16.7 15.7 524 1.79 71.91 0.22 GU042 03D 1055 2 16.7 8.8 509 1.04 89.89 0.10 GU043 03D 300 2 16.7 2.5 406 0.37 64.92 0.04 GU044 03D 1296 2 16.7 10.8 510 1.27 79.90 0.14 GU045 03D 414 2 16.7 3.5 423 0.49 39.92 0.09 GU046 03D 1040 2 16.7 8.7 560 0.93 61.87 0.14 GU047 03D 7034 2 16.7 58.7 699 5.03 103.78 0.57 GU048 03D 926 2 16.7 7.7 105 4.41 39.95 0.19 GU049 03D 1042 2 16.7 8.7 375 1.39 39.95 0.22 Arithmetic Mean 14.7 1.9 0.2      38    39 Table 10. Potential Inhalation Exposure Trial Number Total Inhalation Residuea ( ng) Flow Rate ( L/ min) NAFTA Breathing Rate ( L/ min) Potential Inhalation Exposure b ( µ g) Sampling time ( min) Concentration ( µ g/ m3) c lb ai handled Inhalation Exposure d ( µ g/ lb ai handled)

Geometric Mean 10.4 1.4 0.2 Standard Deviation 14.8 1.5 0.2 a Total Inhalation Residue is the sum of the azinphos methyl and azinphos methyl oxon residues corrected for field fortification recovery values. b Potential Inhalation Exposure ( µ g) =( Total inhalation residue ( ng) / 1000 ng/ µ g) * ( Breathing rate ( 16.7 L/ min) / Flow rate ( L/ min)) c Concentration ( µ g/ m3) = Total Inhalation Residue ( µ g) / [( Flow Rate ( L/ min) * Sampling Time ( min)) / 1000 L/ m3] d Potential Inhalation Exposure ( µ g/ lb ai handled) = Potential Inhalation Exposure ( µ g) / lb ai handled      39    39


[Federal Register Volume 79, Number 42 (Tuesday, March 4, 2014)]
[Rules and Regulations]
[Page 12064]
[FR Doc No: 2014-04737]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2014-0071]

Drawbridge Operation Regulation; Bishop Cut, Near Stockton, CA

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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

SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the San Joaquin County highway bridge
across Bishop Cut, mile 1.0 near Stockton, CA. The deviation is
necessary to allow PG&E Company to temporarily interrupt electric
service to the area while installing new overhead equipment. This
deviation allows the bridge to remain in the closed-to-navigation
position during the deviation period.

DATES: This deviation is effective from 8 a.m. to 4 p.m. on March 14,
2014.

ADDRESSES: The docket for this deviation, [USCG-2014-0071], is
available at http://www.regulations.gov. Type the docket number in the
``SEARCH'' box and click ``SEARCH.'' Click on Open Docket Folder on the
line associated with this deviation. You may also visit the Docket
Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email David H. Sulouff, Chief, Bridge
Section, Eleventh Coast Guard District; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Cheryl Collins, Program Manager, Docket Operations, telephone 202-
366-9826.

SUPPLEMENTARY INFORMATION: The County of San Joaquin Public Works
Department has requested a temporary change to the operation of the San
Joaquin County highway bridge, mile 1.0, over Bishop Cut, near
Stockton, CA. The drawbridge navigation span provides approximately 6
feet vertical clearance above Mean High Water in the closed-to-
navigation position. In accordance with 33 CFR 117.143, the draw opens
on signal if at least 12 hours notice is given to the San Joaquin
County Department of Public Works at Stockton. Navigation on the
waterway is commercial and recreational.
    The drawspan will be secured in the closed-to-navigation position
from 8 a.m. to 4 p.m. on March 14, 2014 to allow PG&E Company to
install new overhead equipment in the vicinity. This temporary
deviation has been coordinated with the waterway users. No objections
to the proposed temporary deviation were raised.
    Vessels able to pass through the bridge in the closed position may
do so at any time. The bridge will not be able to open for emergencies,
and Disappointment Slough can be used as an alternate route for vessels
unable to pass through the bridge in the closed position. The Coast
Guard will also inform the users of the waterways through our Local and
Broadcast Notices to Mariners of the change in operating schedule for
the bridge so that vessels can arrange their transits to minimize any
impact caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: February 21, 2014.
D.H. Sulouff,
District Bridge Chief, Eleventh Coast Guard District.
[FR Doc. 2014-04737 Filed 3-3-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 107 (Friday, June 3, 2016)]
[Notices]
[Page 35790]
[FR Doc No: 2016-13180]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4238-DR; Docket ID FEMA-2016-0001]

Missouri; Amendment No. 2 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for State of Missouri (FEMA-4238-DR), dated August 7, 2015, and related
determinations.

DATES: Effective Date: May 13, 2016.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, William L.
Vogel, of FEMA is appointed to act as the Federal Coordinating Officer
for this disaster.
    This action terminates the appointment of Michael L. Parker as
Federal Coordinating Officer for this disaster.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2016-13180 Filed 6-2-16; 8:45 am]
 BILLING CODE 9111-23-P