[Federal Register Volume 76, Number 248 (Tuesday, December 27, 2011)]
[Notices]
[Pages 81013-81014]
[FR Doc No: 2011-33163]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2011-0342]

Pipeline Safety: Information Collection Activities

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

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, PHMSA
invites comments on an information collection under Office of
Management and Budget (OMB) Control No. 2137-0584, ``Gas Pipeline
Safety Program Certification and Hazardous Liquid Pipeline Safety
Program Certification.'' PHMSA will request approval from OMB for a
renewal of the current information collection with no revisions.

DATES: Interested persons are invited to submit comments on or before
February 27, 2012.

ADDRESSES: Comments may be submitted in the following ways:
    E-Gov Web Site: http://www.regulations.gov. This site allows the
public to enter comments on any Federal Register notice issued by any
agency.
    Fax: 1-(202) 493-2251.
    Mail: Docket Management Facility; U.S. Department of Transportation
(DOT), 1200 New Jersey Avenue SE., West Building, Room W12-140,
Washington, DC 20590-0001.
    Hand Delivery: Room W12-140 on the ground level of DOT, West
Building, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m.
and 5 p.m., Monday through Friday, except Federal holidays.
    Instructions: Identify the docket number, PHMSA-2011-0342, at the
beginning of your comments. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. You should know that anyone is able to
search the electronic form of all comments received into any of our
dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). Therefore, you may want to review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477) or visit http://www.regulations.gov before
submitting any such comments.
    Docket: For access to the docket or to read background documents or
comments, go to http://www.regulations.gov at any time or to Room W12-
140 on the ground level of DOT, West Building, 1200 New Jersey Avenue
SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. If you wish to receive confirmation of receipt
of your written comments, please include a self-addressed, stamped
postcard with the following statement: ``Comments on PHMSA-2011-0342.''
The Docket Clerk will date stamp the postcard prior to returning it to
you via the U.S. mail. Please note that due to delays in the delivery
of U.S. mail to Federal offices in Washington, DC, we recommend that
persons consider an alternative method (Internet, fax, or professional
delivery service) of submitting comments to the docket and ensuring
their timely receipt at DOT.

FOR FURTHER INFORMATION CONTACT: Angela Dow by telephone at (202) 366-
1246, by fax at<PHONE_NUMBER>, or by mail at DOT, PHMSA, 1200 New
Jersey Avenue SE., PHP-30, Washington, DC 20590-0001.

SUPPLEMENTARY INFORMATION: Section 1320.8(d), Title 5, Code of Federal
Regulations, requires PHMSA to provide interested members of the public
and affected agencies an opportunity to comment on information
collection and recordkeeping requests. This notice identifies an
information collection request that PHMSA will be submitting to OMB for
renewal. The following information is provided for that information
collection: (1) Title of the information collection; (2) OMB control
number; (3) Current expiration date; (4) Type of request; (5) Abstract
of the information collection activity; (6) Description of affected
public; (7) Estimate of total annual reporting and recordkeeping
burden; and (8) Frequency of collection. PHMSA will request a three-
year term of approval for the information collection activity. PHMSA
requests comments on the following information collection:
    Title: Gas Pipeline Safety Program Certification and Hazardous
Liquid Pipeline Safety Program Certification.
    OMB Control Number: 2137-0584.
    Current Expiration Date: 6/30/2012.
    Abstract: A state must submit an annual certification to assume
responsibility for regulating intrastate pipelines, and certain records
must be maintained to demonstrate that the state is ensuring
satisfactory compliance with the pipeline safety regulations. PHMSA
uses that information to evaluate a state's eligibility for Federal
grants.
    Affected Public: State and local governments.
    Annual Reporting and Recordkeeping Burden:
    Total Annual Responses: 67.
    Total Annual Burden Hours: 3,820.
    Frequency of Collection: Annually.
    Comments are invited on:
    (a) The need for the proposed collection of information for the
proper performance of the functions of the agency, including whether
the information will have practical utility;
    (b) The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
    (c) Ways to enhance the quality, utility, and clarity of the
information to be collected; and
    (d) Ways to minimize the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques.

    Issued in Washington, DC on December 16, 2011.
John A. Gale,
Director, Office of Standards and Rulemaking.
[FR Doc. 2011-33163 Filed 12-23-11; 8:45 am]
BILLING CODE 4910-60-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C. 20460

                                                  OFFICE OF CHEMICAL SAFETY AND
                                                           POLLUTION PREVENTION

DATE:		November 30, 2011

MEMORANDUM

	SUBJECT:	Amicarbazone:  Occupational and Residential Exposure Assessment for Proposed Uses on Turf, Christmas Tree Farms, Non-Crop Areas and on Conifers in Nurseries.

PC Code:  114004
DP Barcode:  D394924
Decision No.:  441345
Registration Nos.:  66330-46
Petition Nos:  NA
Regulatory Action:  Section 3 Registration
Assessment Type:  Occupational/Residential
Case No.:  NA
TXR No.:  NA
CAS Number:  129909-90-6
MRID:  NA
40 CFR:  180.615

FROM:		Zaida Figueroa, Industrial Hygienist
		Risk Assessment Branch (RAB) II
		Health Effects Division (7509P)

THROUGH:	Richard A. Loranger, Ph.D., Branch Senior Scientist
		Risk Assessment Branch (RAB) II
		Health Effects Division (7509P)

TO:		Michael Walsh/Kathryn Montague, RM Team 23
		Herbicide Branch
		Registration Division (7505P)

Action Requested:

The Registration Division (RD) requested that the Health Effects Division (HED) conduct an exposure and risk assessment for proposed uses of the herbicide amicarbazone to control broadleaf weeds in residential and commercial lawns, golf course, sod farms, recreational turf, non-crop areas, Christmas tree farms and conifers in nurseries.  The proposed use pattern results in the first residential use for the active ingredient.  Note: This memorandum was reviewed by the Exposure Science Advisory Committee (ExpoSAC) on October 20, 2011.

1.0	Executive Summary

Amicarbazone, 4-amino-4,5-dihydro-N-(1,1-dimethylethyl)-3-(1-methylethyl)-5-oxo-1H-1,2,4-triazole-1-carboxamide, is a triazolinone herbicide related to carfentrazone, flucarbazone, propoxycarbazone, and sulfentrazone.  A Section 3 registration of a dry flowable formulation is requested by Arysta LifeScience North America, LLC for use on turf (lawns, golf course, sod farms, recreational turf), ornamentals, non-crop areas, Christmas tree farms and conifers in nurseries.  Application timing includes pre-emergence and early post-emergence to control broadleaf weeds.  Amicarbazone may be applied through a variety of application methods including ground equipment, backpack, and hand held equipment.

This assessment addresses exposure and risk associated with the proposed end-use product for amicarbazone when used as directed by commercial applicators as well as residential homeowners.  There is a potential for short- and intermediate-term occupational exposure associated with handler activities (mixing, loading, and applying) as well as with postapplication activities (i.e., re-entering treated areas).  There is also a potential for short-term residential exposure to amicarbazone during handling (mixing, loading, and applying), and postapplication activities.  Chronic exposure is not expected for the proposed use patterns.

Hazard Characterization
The toxicology database is complete and adequate for purposes of this risk assessment.  Amicarbazone exhibits low acute toxicity.  The available database indicates that the major effects in mammals are general toxicity, as evidenced by decreased body weight and weight gain, and liver toxicity.  The mutagenicity battery for this chemical is complete and indicates that amicarbazone is not a mutagen.  Amicarbazone has been classified as "not likely to be a human carcinogen".  Although the acute neurotoxicity study in rats showed signs of neurotoxicity, no such effects were seen in the subchronic and developmental neurotoxicity studies.

In the previous risk assessment for amicarbazone (K. Kosick, 8/10/2005, D288216), HED concluded there was no dermal endpoint based on the lack of systemic toxicity or local dermal irritation from a 21-day dermal toxicity study in the rat.  Using a ratio of the LOAELs from several oral studies in the rat to the NOAEL from the 21-day dermal rat study (1000 mg/kg/day), a conservative dermal absorption factor of less than 5% was estimated.  Therefore, dermal absorption is not considered to be a major route of uptake for this chemical and the dermal route of exposure was not considered for this risk assessment.  In the absence of a route-specific study for inhalation, HED selected an endpoint from the 90-day dog study for the inhalation exposure and risk assessment.  There were numerous effects observed at the LOAEL of 25 mg/kg/day (thyroid, liver, gall bladder, and blood); the NOAEL of 6.28 mg/kg/day was selected as the point of departure for inhalation risk assessment.  Since no inhalation toxicity data are available, toxicity by the inhalation route is considered to be equivalent to toxicity by the oral route of exposure.

For the current risk assessment, HED selected an endpoint for the purpose of assessing children's incidental oral exposure on treated turf.  Only short-term (1-30 days) durations are relevant for this route of exposure.  The same subchronic oral toxicity study in the dog used for assessing inhalation exposure and risk was selected for assessing incidental oral exposure.

FQPA and Uncertainty Factors
The database is complete with respect to pre- and post-natal toxicity and shows no evidence of increased qualitative or quantitative susceptibility.  Although neurotoxicity was observed with exposure to amicarbazone in adult animals in gavage studies, no neurotoxic effects were observed in offspring at dose levels that resulted in general systemic toxicity.  Potential immunotoxic effects were observed in the chronic dog and rat immunotoxicity studies only at doses greater than those selected for risk assessment and are therefore not of concern.  HED recommends that the special 10X FQPA safety factor be reduced to 1X.  No other database uncertainty factors are needed.  The combined uncertainty factors of 100X (10X for intraspecies variability and 10X for interspecies extrapolation) serve as the level of concern (LOC) for occupational and residential exposure and risk.  Margins of exposure (MOEs) greater than 100 are not of concern.

Residential Handler Exposure
A dermal exposure assessment was not performed for residential handlers because no dermal endpoints were selected.  Inhalation MOEs for handlers were significantly greater than the LOC of 100 (ranging from 3,600 to 220,000) and are not of concern.

Residential Postapplication Exposure
In the absence of a dermal endpoint, oral non-dietary ingestion exposures were assessed for children (i.e. soil ingestion, and hand-/object-to-mouth).  The postapplication scenarios resulting from commercial and residential applications were assessed using the HED Draft Standard Operating Procedures (SOP's) for Residential Exposure Assessments, 2000.  Short-term hand-to-mouth (HTM), object-to-mouth (OTM) and soil ingestion scenarios resulted in MOEs ranging from 910 to 270,000, and are not of concern.

Since the proposed uses of amicarbazone are applied only in outdoor settings and amicarbazone has a low vapor pressure (2.3 x 10[-][8] mm Hg), postapplication residential inhalation exposure and risk estimates were not quantitatively assessed.

Summary of Residential Exposure
HED combines risk values resulting from separate exposure scenarios when it is likely they can occur simultaneously based on the use pattern and the behavior associated with the exposed population.  However, since a dermal endpoint was not selected, the only relevant route of exposure for adults is through the inhalation route.  Therefore, an adult combined residential exposure assessment was not conducted.  Similarly, the only relevant route of exposure for children was through the oral route, and therefore a combined residential exposure assessment was not conducted for children.

Occupational Handler Exposure
It is the policy of HED to use the best available data to assess handler exposure.  Sources of generic handler data, used as surrogate data in the absence of chemical-specific data, include the Pesticide Handlers Exposure Database Version 1.1 (PHED 1.1), the Agricultural Handler Exposure Task Force (AHETF) database, the Outdoor Residential Exposure Task Force (ORETF) database, or other registrant-submitted occupational exposure studies.  Some of these data are proprietary (e.g., AHETF data, MRID No. 44339801), and subject to the data protection provisions of FIFRA.  Default assumptions established by the Health Effects Division (HED) Science Advisory Council for Exposure were used for parameters such as body weight, acres treated and amount handled.  All occupational handler scenarios resulted in MOEs greater than the level of concern at the baseline PPE level of protection (i.e. single layer clothing and no respirator).

Occupational Postapplication Exposure
In the absence of a dermal endpoint, a dermal postapplication exposure assessment was not conducted.  Furthermore, since the proposed uses of amicarbazone are in outdoor settings where postapplication inhalation exposures are expected to be minimal, and because amicarbazone has a low vapor pressure (2.3 x 10[-][8] mm Hg), handler inhalation exposure estimates are considered to be protective of occupational postapplication inhalation exposure scenarios.

Restricted Entry Interval
The restricted entry interval (REI) listed on proposed labels is based on the acute toxicity of the technical material.  Amicarbazone exhibits low acute toxicity and is classified as Toxicity Category III for eye irritation and Category IV for acute dermal and dermal irritation.  It is not a dermal sensitizer.  Acute toxicity Category III and IV chemicals require a 12-hour REI.  Therefore, the 12-hour REI which appears on the proposed labels is considered appropriate.

Review of Human Research
This risk assessment relies in part on data from studies in which adult human subjects were intentionally exposed to a pesticide or other chemical.  These data, which include studies from the Pesticide Handlers Exposure Database Version 1.1 (PHED 1.1); the Agricultural Handler Exposure Task Force (AHETF) database; and the Outdoor Residential Exposure Task Force (ORETF) database; are subject to ethics review pursuant to 40 CFR 26, have received that review, and are compliant with applicable ethics requirements.  For certain studies that review may have included review by the Human Studies Review Board.  Descriptions of data sources as well as guidance on their use can be found at http://www.epa.gov/pesticides/science/handler-exposure-data.html  and http://www.epa.gov/pesticides/science/post-app-exposure-data.html.

Label Recommendations

The Registration Division (RD) should ensure the final label does not include the potential for application to Christmas trees using a mechanically pressurized handgun.  No other recommendations are needed based on HED's residential exposure and risk assessment.

2.0.	Hazard Characterization

Amicarbazone is a triazolinone herbicide which controls broadleaf weeds by selective inhibition of acetolactase synthase, an enzyme involved in photosystem II in plants.  The available database indicates that the major effects in mammals are general toxicity, as evidenced by decreased body weight and weight gain, and liver toxicity.  Decreased body weight and weight gain were observed in studies with rats, mice and rabbits and were the most sensitive toxicological endpoints observed in many of the studies.  In the chronic dog and subchronic rat and dog studies, liver effects were seen; including increased absolute and relative liver weights, slight liver hypertrophy, dilation of sinusoids and increased liver enzymes and cholesterol/triglycerides.

2.1	Hazard Profile

The toxicology database is complete and adequate for risk assessment.  Amicarbazone exhibits low acute toxicity.  The available database indicates that the major effects in mammals are general toxicity, as evidenced by decreased body weight and weight gain, and liver toxicity.  The mutagenicity battery for this chemical is complete and indicates that amicarbazone is not a mutagen.  Amicarbazone has been classified as "not likely to be a human carcinogen".  Although the acute neurotoxicity study in rats showed signs of neurotoxicity, no such effects were seen in the subchronic and developmental neurotoxicity studies.

No dermal endpoint was selected for risk assessment, based on the lack of systemic toxicity or local dermal irritation in a 21-day dermal toxicity study in the rat.  Using a ratio of the LOAELs from several oral studies in the rat to the NOAEL from the 21-day dermal rat study (1000 mg/kg/day), a conservative dermal absorption factor of less than 5% was estimated.  Therefore, dermal absorption is not considered to be a major route of exposure for this chemical and the dermal route of exposure was not considered for this risk assessment.  There was no route-specific inhalation toxicity study available for endpoint selection.  Therefore, for short-term (1-30 days) and intermediate-term (1-6 months) inhalation risk assessment, the endpoint was selected from a dog subchronic oral toxicity study in which numerous toxic effects were observed at the LOAEL of 25 mg/kg/day.  These effects included thyroid, liver, gall bladder and blood toxicity.  The NOAEL for the study was 6.28 mg/kg/day, which served as the point of departure for risk assessment.  For extrapolation from oral to inhalation exposure, toxicity via the inhalation route was assumed to be equivalent to toxicity via the oral route.

2.2	FQPA and Uncertainty Factor Considerations

HED has recommended the 10x FQPA factor be reduced to 1x.  No evidence of increased quantitative or qualitative susceptibility was observed in the rat and rabbit developmental toxicity, rat reproductive toxicity or the rat developmental neurotoxicity studies.  Although neurotoxicity was observed with exposure to amicarbazone in adult animals in gavage studies, no neurotoxic effects were observed in offspring in the rat developmental neurotoxicity study at dose levels that resulted in general systemic toxicity (decreased offspring and maternal body weight).  Potential immunotoxic effects (chronic dog and rat immunotoxicity studies) were observed only at doses greater than those selected for risk assessment purposes and are therefore not of concern.

Given the completeness of the database, there are no database uncertainty factors to be retained during risk assessment, and therefore the level of concern (LOC) is a margin of exposure (MOE) of 100, based on the combined uncertainty factors of 100X (10X for interspecies extrapolation and 10X for intraspecies variability).  MOEs greater than the LOC of 100 are not of concern.

Table 1.  Acute Toxicity Profile for Amicarbazone.
                                 Guideline No.
Study Type
MRID(s)
                                    Results
                                 Tox Category
870.1100
Acute oral - Wistar rats
                                   45121504
Males LD50 > 2050 mg/kg
Females LD50 = 1015 mg/kg
                                      III
870.1200
Acute dermal - Wistar rats
                                   45121503
LD50  > 5000 mg/kg
                                      IV
870.1300
Acute inhalation - Wistar rats
                                   45121506
LC50 > 2.030 mg/L
                                      IV
70.2400
Acute eye irritation - New Zealand white rabbit
                                   45121510
Eye irritation was present (including corneal opacity) at 24 hours, but had cleared by day 7.
                                      III
870.2500
Acute dermal irritation - New Zealand white rabbit
                                   45121509
Primary irritation indices were 0
                                      IV
870.2600
Skin sensitization - Hartley guinea pig
                                   45121628
                                   45121505
All scores during induction and challenge periods were 0.
                            Not a dermal sensitizer

Table 2.  Summary of Toxicological Doses and Endpoints for Amicarbazone for Use in Human Health Risk Assessments.
                              Exposure/ Scenario
                              Point of Departure
                        Uncertainty/FQPA Safety Factors
                     Level of Concern for Risk Assessment
                        Study and Toxicological Effects
Incidental Oral Short-Term (1-30 days)
NOAEL= 6.28 mg/kg/day
UFA= 10x
UFH=10x
FQPA SF= 1x

Residential LOC for MOE = 100
90-Day Oral Toxicity in Dogs
LOAEL = 25 mg/kg/day based on increased thyroid vacuolization and decreased food consumption and glucose in females; increased platelets, phosphate, bile acids, absolute and relative liver weights, and lymphoid hyperplasia of the gall bladder in males; and decreased albumin and increased triglycerides, N-demethylase and O-demethylase in both sexes.
Dermal (all durations)
No systemic toxicity was observed at the limit dose.  Evidence of low dermal absorption was estimated by comparison of oral and dermal studies in the rat.
Inhalation Short-  and Intermediate-Term (1-30 days and 1-6 months, respectively)
NOAEL= 6.28 mg/kg/day

(Inhalation toxicity considered equivalent to oral toxicity)
UFA= 10x
UFH=10x
FQPA SF= 1x

Occupational/Residential LOC for MOE = 100
90-Day Oral Toxicity in Dogs
LOAEL = 25 mg/kg/day based on increased thyroid vacuolization and decreased food consumption and glucose in females; increased platelets, phosphate, bile acids, absolute and relative liver weights, and lymphoid hyperplasia of the gall bladder in males; and decreased albumin and increased triglycerides, N-demethylase and O-demethylase in both sexes.
Cancer (oral, dermal, inhalation)
Classification:  There was no treatment-related increase in tumor incidence when compared to control.  Dosing was considered adequate.  This chemical is not likely to be a carcinogen.
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and  used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures.  NOAEL = no observed adverse effect level.  LOAEL = lowest observed adverse effect level.  UF = uncertainty factor.  UFA = extrapolation from animal to human (interspecies).  UFH = potential variation in sensitivity among members of the human population (intraspecies).  FQPA SF = FQPA Safety Factor.  MOE = margin of exposure.  LOC = level of concern.

3.0	Proposed Use Patterns

Amicarbazone, 4-amino-4,5-dihydro-N-(1,1-dimethylethyl)-3-(1-methylethyl)-5-oxo-1H-1,2,4-triazole-1-carboxamide, is a triazolinone compound proposed for the control of annual broadleaf weeds.  Amicarbazone selectively inhibits acetolactase synthase, an enzyme involved in photosystem II of plants.  Related compounds include carfentrazone, flucarbazone, propoxycarbazone, and sulfentrazone.

Arysta LifeSciences North America, LLC is currently seeking use of amicarbazone for control of broadleaf weeds in turf (i.e., lawns, sod farms, golf courses, recreational fields, etc), ornamentals, non-crop areas, Christmas tree farms and conifers in nurseries.  Amicarbazone is formulated as a 70% dry flowable powder.  It is intended for pre-emergence and post-emergence applications.  Broadcast applications are to be made with ground equipment only; spot treatments are to be made using backpacks and hand held equipment.  The product is not to be applied by aerial equipment or through irrigation systems.

Amicarbazone is available for use by commercial and professional applicators.  This herbicide works best when applied and subsequently moved into the soil by rainfall.  The personal protective equipment (PPE) for the proposed label consists of baseline clothing (i.e., long-sleeved shirt and long pants, shoes and socks) and use of chemical resistant gloves.  The proposed uses are anticipated to result in short- and intermediate-term exposure durations.  Table 3 provides a summary of the proposed uses.

Table 3.  Proposed Products and Uses of Amicarbazone.
Product Trade Name
(EPA Reg. No.)
                                     Crops
                             Method of Application
                        Maximum Application Rates[†]
                      Maximum Seasonal Application Rates
                       Maximum # Applications per Season
                   Use Directions and other Limitations[‡]
Amicarbazone DF Herbicide (DINAMIC
70 WDG HERBICIDE)
70% ai
(EPA Reg. No. 66330-46)
Turf, golf course, sod farms, parks and recreation areas, athletic fields, landscape plants and tree nurseries, and Christmas trees farms
                                   Directed;
                    Broadcast using ground equipment only.
            Spot treatment using backpack and compression sprayers.
                       0.46 lb ai/A (single application)
                               (10.5 oz prod/A)
                               (0.023 lb ai/gal)
                               0.46 lbs ai/ A/yr
                         1 appl at the max appl. rate.
                   2-4 appls for turf grass at a lower rate.

12-hr REI
Application intervals from 14-21 days, but may vary depending on application rate.
Do not apply within 4 weeks of cutting or lifting sod.
Do not apply this product using aerial equipment or any irrigation system.
[†]  Max Single Application Rate = (70% ai) (1 lbsolid/16 oz) (10.5 oz/A) = 0.46 lb ai/A (1 A/20gal) = 0.023 lb ai/gal.
[‡]  Minimum Spray Volume = 20 gal/A.

Note:  The proposed label states that the maximum single application rate for turf is 10 oz prod/A.  However, for purposes of this assessment HED used the maximum single application rate of 10.5 oz prod/A based on information provided by the registrant (MRID No. 48237522).

4.0 Residential (Non-Occupational) Exposure

4.1	Residential Handler Exposure and Risk

The Agency uses the term "Handlers" to describe those individuals who are involved in the pesticide application process.  Based on the proposed label (EPA Reg. No. 66330-46) and information provided by the registrant (MRID No. 48237522), this product is to be applied by professional applicators.  The proposed label includes occupational/commercial mixing/loading activities, PPE and REI requirements.  However, since the proposed label does not identify this product as a restricted use pesticide, a residential handler exposure assessment was performed to be protective of potential homeowner exposure.

The following exposure scenarios and unit exposures were used to assess residential handlers for broadcast and spot treatments:

   * Mixing/Loading/Applying for Sprays with Backpack Sprayer;
   * Mixing/Loading/Applying for Sprays Using Low-Pressure Handwand; and,
   * Mixing/Loading/Applying for Sprays with Hand-Gun Sprayer (hose-end).

4.1.1	Data and Assumptions

Unit Exposures:  No chemical specific unit exposure data were provided in support of this submission; therefore, HED used data from the PHED Surrogate Exposure Guide for Residential Handlers, Version 1.1, August 1998 and the Occupational Residential Exposure Task Force (ORETF) (MRID 449722-01).

Acres/Amount Treated:  Information regarding area treated for the various use scenarios was provided by the Science Advisory Council for Exposure Policy #12: Recommended Revisions to the Standard Operating Procedures (SOPs) for Residential Exposure Assessments.

Exposure Duration:  Based on information provided in the proposed labels, residential handler exposure is anticipated to be short-term in duration.

Body Weight:  The average adult body weight of 70 kilograms was used to assess handler exposure since the endpoints were not gender specific.

4.1.2	Residential Handler Exposure and Risk Estimates

A quantitative dermal assessment for residential handlers was not conducted since no systemic toxicity by the dermal route was seen at the limit dose in the dermal toxicity study.  Handler inhalation exposure scenarios resulted in MOEs greater than 100 and therefore are not of concern.  Handler exposure and risk estimates are summarized in Table 4.

Table 4.  Residential Handler Exposure Estimates for Amicarbazone.
                                   Scenario
                         Inhalation Unit Exposure[a]
                                  (mg/lb ai)
                             Application Rate [b]

                              Amount Treated [c]
                        Inhalation Dose[d] (mg/kg/day)
                              Inhalation MOE [e]
                                Mix/Load/Apply
Backpack Sprayer
(Ground Directed)
                                0.03 (Baseline)
                                    (PHED)

                                     0.023
                                   lb ai/gal
                                     5 Gal
                                   0.0000493
                                    130,000
Low Pressure Handwand
                               1.063 (Baseline)
                                    (PHED)

                                     5 Gal
                                    0.00175
                                     3,600
Hose-end (for Handgun
Sprayer)
 (Mix your own)
                        0.017 (Baseline) (ORETF-OMA004)
                                0.023 lb ai/gal
                                     5 Gal
                                   0.000028
                                    220,000

                                     0.46
                                    lb ai/A
                                     0.5 A
                                   0.000056
                                    110,000
a.  PHED Surrogate Exposure Guide for Residential Handlers, Version 1.1, August 1998.  Occupational Residential Exposure Task Force (ORETF) Study Data (MRID 449722-01).
b.  Application Rate = (70% ai) (1 lbsolid/16 oz) (10.5 oz/A) = 0.46 lb ai/A (1 A/20gal) = 0.023 lb ai/gal.
c.  Policy 12: Recommended Revision to the SOPs for Residential Exposure Assessment.
d.  Inhalation Dose (mg/kg/day) = Inhalation Unit Exposure (mg/lb ai) * Application Rate * Acres Treated or Amount Handled / Body Weight (70 kg).
e  Inhalation MOE = NOAEL (6.28 mg/kg/day) / Inhalation Dose (mg/kg/day).
4.2	Residential Postapplication Exposure

Amicarbazone residential postapplication scenarios include children (3 to 6 years) playing on treated turf, adults performing yard work on treated turf and adults playing golf on treated turf.
As a result, a wide array of individuals of varying ages can potentially be exposed when they do activities in areas that have been treated.

The postapplication scenarios were assessed using the HED Draft Standard Operating Procedures (SOP's) for Residential Exposure Assessments, 2000.  Since no chemical-specific residue data were submitted for this action, postapplication exposures were assessed using default assumptions from the Residential Exposure SOPs.

1.0.1 Inhalation Postapplication Exposure

Based on the Agency's current practices, a quantitative postapplication inhalation exposure assessment was not performed for amicarbazone at this time primarily because of the low acute inhalation toxicity (Toxicity Category IV) , the low vapor pressure (2.3 x 10[-][8] mm Hg) and the proposed application rate (0.46 lb ai/A).  However, volatilization of pesticides may be a potential source of postapplication inhalation exposure to individuals nearby to pesticide applications.  The Agency sought expert advice and input on issues related to volatilization of pesticides from its Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (SAP) in December 2009, and received the SAP's final report on March 2, 2010 (http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html).  The Agency is in the process of evaluating the SAP report and may, as appropriate, develop policies and procedures to identify the need for and, subsequently, the way to incorporate post-application inhalation exposure into the Agency's risk assessments.  If new policies or procedures are developed, the Agency may revisit the need for a quantitative pos-application inhalation exposure assessment for amicarbazone.

2.0.2 Dermal Postapplication Exposure

In assessing potential dermal postapplication exposure and risk estimates, HED assumes that pesticide residues are transferred to the skin of adults/children who enter treated yards for recreation or other activities such as yard work and golfing.  However, a quantitative postapplication dermal exposure assessment was not performed for adults and children since no dermal endpoints were selected.  If dermal toxicological endpoints change in the future, HED may require a turf transferable residue (TTR) study to confirm that assessments are protective of all turf uses.

3.0.3 Non-Dietary Ingestion (Hand-to-Mouth) Exposure

For the assessment of non-dietary ingestion (hand-to-mouth) exposure, HED assumes that pesticide residues are transferred to the skin of children playing on treated areas and are subsequently ingested as a result of hand-to-mouth transfer.

Assumptions:

   * On the day of application, it is assumed that 5% of the application rate is available on turf grass as transferable residue.
   * Oral postapplication exposure was estimated using the standard assumption for the initial fraction of residues available and assuming a 10% daily dissipation rate.
   * The median surface area of both hands is 20 cm[2] for children.
   * It is assumed that there is a one-to-one relationship between the dislodgeable residues on the turf and on the surface area of the skin after contact.
   * The mean rate of hand-to-mouth activity is 20 times/hour for short-term exposure scenarios.
   * The saliva extraction factor is 50%.
   * The children (3-6 yrs) are assumed to weigh 15 kg.
   * Duration of exposure for children is assumed to be 2 hours per day for turf.

Equations:

TTRt = AR x F x (1-D)[t] x CF2 x CF3

TTR	=	Turf Transferable Residue;
AR	= 	Application rate (lb ai/acre);
F	=	Fraction of ai available on turf (unitless) (0.05);
D	=	Fraction of residue that dissipates daily (unitless) (0.1);
t 	=	Postapplication day on which exposure is being assessed;
CF2	=	Weight unit conversion factor to convert the lbs ai in the application rate to ug for DFR
		value (4.54 x 10[8] ug/lb); and,
CF3	=	Area unit conversion factor to convert the surface area units (acre) in the application rate
			to cm[2] for the DFR value (2.47 x 10[-8] acre/cm[2]).

PDR = TTR x SA x FQ x ET x SE x CF1
            BW

PDR	=	Potential dose rate (mg/day);
TTR	=	Turf transferable residue (ug/cm[2] turf);
SA	=	Surface area of the hands (20 cm[2]/event);
FQ	=	Frequency of hand-to-mouth activity (20 events/hr for short-term) ;
ET	=	Exposure time (hr/day);
CF1		=	Weight unit conversion factor to convert ug units in the TTR value to mg for the daily
			exposure (0.001 mg/ug for turf);
SE	=	Saliva Extraction Factor (50%); and,
BW	=	Body Weight (15 kg).

Hand-to-Mouth Exposure and Risk Estimate

Short-term hand-to-mouth (HTM) exposure resulted in an MOE greater than the level of concern (MOEs >= 100) and therefore poses no risk of concern.  Table 5 provides a summary of the short-term HTM exposure estimate.

Table 5.  Amicarbazone Children's Short-term Non-Dietary Ingestion (Hand-to-Mouth) Exposure and Risk Estimate.
Product
TTR 1 (ug/cm[2])
SA (cm[2]/event)
FQ
SE
ET (hr/day)
CF1
BW (kg)
HTM Dose [2]
(mg/kg/day)
HTM MOE [3]
Amicarbazone DF Herbicide (DINAMIC
70 WDG HERBICIDE)
70% ai
(EPA Reg. No. 66330-46)
0.2576
                                      20
                                      20
                                      0.5
                                       2
                                     0.001
                                      15
                                    0.00687
                                      910
   1. Turf Transferable Residues = (TTR) =
   AR (0.46 lb ai/A) x F (0.05) x (1-D)[0] x CF2 (4.54E[8] ug/lb) x CF3 (2.47E[-8] acre /cm[2]) = 0.2576 ug/cm[2].
   2. HTM Dose = [TTRt x SA x FQ x ET x SE x CF1]/BW.
   3. HTM MOE = NOAEL (6.28 mg/kg/day)/HTM Dose (mg/kg/day).

4.0.4 Non-Dietary Ingestion (Object to Mouth Ingestion of Treated Turf) Exposure

This scenario estimates exposure to children (3-6 yrs) resulting from incidental ingestion of pesticide and/or residential turf grass that has been treated with pesticides.  It assumes that pesticide from a treated object or turf is ingested by children who play on treated areas.

Assumptions:

   * On the day of application it is assumed that 20% of the application rate is available to be ingested.
   * Oral postapplication exposure was estimated using the standard assumption for the initial fraction of residues available and assuming a 10% daily dissipation rate.
   * Assumed ingestion rate for grass for children (3 years old) is 25 cm[2]/day.
   * Children are assumed to weigh 15 kg.

Equations:

GRt = AR x F x (1-D)[t] x CF2 x CF3

GRt	=	grass residue on day t (ug/cm[2]);
AR	=	application rate (lb ai/A);
F	=	fraction of ai available on the grass (unitless) (0.2);
D	=	fraction of residue that dissipates daily (unitless) (0.1);
t	=	postapplication day on which exposure is being assessed;
CF2		=	weight unit conversion factor to convert the lbs ai in the application rate to ug for grass
			residue value (4.54 x 10[8] ug/lb); and,
CF3	=	area unit conversion factor to convert surface area units (A) in the application rate to cm[2]
		for grass residue value (2.47 x 10[-8] A/cm[2]).

PDD = GR t x IgR x CF1

PDD	=	potential daily dose (mg/kg/day);
GRt	=	grass residue (ug/cm[2]);
IgR	=	ingestion rate of grass (cm[2]/day); and,
CF1	=	weight unit conversion factor to convert the ug of residues on the grass to mg to 	provide
		units of mg/day (1.0 x 10[-3] mg/ug).

Object-To-Mouth Exposure and Risk Estimate

The object-to-mouth (OTM) scenario resulted in an MOE greater than the level of concern (MOEs >= 100) and therefore poses no risk of concern.  Table 6 provides a summary of the OTM exposure and risk estimate.

Table 6.  Amicarbazone Children's Non-Dietary Ingestion (Object - to-Mouth) Exposure and Risk Estimate.
                                    Product
GR 1 (ug/cm[2])
CF1 (mg/ug)
IgR  (cm[2]/day)
BW (kg)
OTM Dose 2 (mg/kg/day)
OTM MOE [3]
Amicarbazone DF Herbicide (DINAMIC 70 WDG HERBICIDE)
70% ai
(EPA Reg. No. 66330-46)
1.03
0.001
25
15
0.0017
3,700
  1. GR (grass residue) = Application Rate x F x (1-D)[0] x CF2 x CF3.
  2. OTM Dose = [GR 0 x IgR x CF1]/BW.
  3. OTM MOE = NOAEL (6.28 mg/kg/day)/OTM Dose (mg/kg/day).

0.3.2 Non-Dietary Ingestion Incidental Ingestion of Soil

This scenario assumes children who play on treated areas ingest pesticide residues in soil as a result of normal mouthing activities.

Assumptions:

   * On the day of application, it is assumed that 100% of the application rate is located within the soil's uppermost 1 cm.
   * Postapplication must be assessed on the same day the pesticide is applied.
   * Assumed soil ingestion rate for children is 100 mg/day.
   * Children are assumed to weigh 15 kg.

Equations:

      SR0 = AR x F x (1-D)[t] x CF2 x CF3 x CF4

SR0	=	soil residue on day 0 (ug/g);
AR	=	application rate (lb ai/A);
F	=	fraction of ai available in uppermost cm of soil (1 cm);
D	=	fraction of residue that dissipates daily (unitless);
t	=	postapplication day on which exposure is being assessed (day 0);
CF2		=	weight unit conversion factor to convert the lbs ai in the application rate for soil residue                                   			 value (4.54 x 10[8] ug/lb);
CF3		=	area unit conversion factor to convert surface area units (A) in the application rate to cm[2]
			for soil residue value (2.47 x 10[-8] A/cm[2]); and,
CF4		=	volume to weight unit conversion factor to convert the volume units (cm[3]) to weight units
			for the SR value (0.67 cm[3]/g soil).

      PDD = SR0 x IgR x CF1

PDD	=	potential daily dose on day 0;
SR0	=	soil residue on day 0 (ug/g);
IgR	=	ingestion rate of soil (mg/day); and,
CF1	=	weight unit conversion factor to convert the ug of residues on the soil to mg to provide
		units of mg/day (1.0 x 10[-][6] g/ug).

Soil Ingestion Exposure and Risk Estimate

The soil-ingestion scenario resulted in a MOE much greater than the level of concern (MOEs >= 100) and therefore poses no risk of concern.  This assessment should be considered conservative in that it assumed no dissipation of soil residues would occur over the exposure period.  Table 7 provides a summary of the soil ingestion exposure and risk estimate.

Table 7.  Amicarbazone Children's Soil Ingestion Exposure and Risk Estimate.
                                    Product
SR 1 (ug/g)
CF1
(g/ug)
IgR  (mg/day)
BW (kg)
Dose 2 (mg/kg/day)
MOE [3]
Amicarbazone DF Herbicide (DINAMIC 70 WDG HERBICIDE)
70% ai
(EPA Reg. No. 66330-46)
3.45
0.000001
100
15
0.000023
270,000
   1. SR0 (soil residue) = Application Rate (lb ai/A) x F(1) x (1-D)[0] x 0.67 x (4.54x10[8] ug/lb)x (2.47 x 10-8 A/cm[2]).
   2. Soil Ingestion Dose (mg/kg/day) = SR0 (ug/g) x IgR (mg/day) x CF1 (g/ug)/BW (kg).
   3. Soil Ingestion MOE = NOAEL (6.28 mg/kg/day)/Soil Ingestion Dose (mg/kg/day).

4.3      Summary of Residential Risk Estimates

HED combines risk values resulting from separate exposure scenarios when it is likely they can occur simultaneously based on the use pattern and the behavior associated with the exposed population.  In evaluating combined residential uses of amicarbazone, HED reviewed all residential sources of exposure which consisted of: 1) adult inhalation handler (lawns only) exposure, and 2) child postapplication oral exposure.

Since a dermal endpoint was not selected for amicarbazone, the only relevant route of exposure for adults is through the inhalation route, and therefore, a combined residential exposure assessment is not applicable.

The children's oral exposure estimate for the purpose of conducting an aggregate risk assessment is based on postapplication hand-to-mouth exposures only.  To include exposure from object-to-mouth and soil ingestion in addition to hand-to-mouth could result in a very conservative estimate of exposure since the assumptions for each of the individual oral exposure calculations are high end.

The hand-to-mouth residential postapplication scenario also represents the worst case of oral exposure (i.e., to include exposure from object-to-mouth and soil ingestion in addition to hand-to-mouth could result in a very conservative estimation of exposure as it would overestimate the potential of oral exposure).  Table 8 identifies the residential scenarios and MOEs for adults and children for use in performing an aggregate exposure assessment as part of the amicarbazone human health risk assessment.  There are no risks of concern.

Table 8.  Amicarbazone Summary of Residential Exposure and Risk Estimates.
Product
Use Site
Handler InhalationMOE [1]
Postapplication Dermal MOE
Hand-to-Mouth MOE [2]
Combined MOE [3]
                                    Adult
Amicarbazone DF Herbicide (DINAMIC
70 WDG HERBICIDE
(EPA Reg. No. 66330-46)
                                 Lawns (turf)

                                     3,600

                                      NA

                                      NA

                                      NA
                                     Child
Amicarbazone DF Herbicide (DINAMIC
70 WDG HERBICIDE)
(EPA Reg. No. 66330-46)
                                 Lawns (turf)

                                      NA

                                      NA

                                      910

                                      NA
   1. See Table 4: Residential Handler Exposure and Risk (Low Pressure Handwand).
   2. See Table 5. Hand-To-Mouth Exposure and Risk.
   3. Child MOE = NOAEL (6.28 mg/kg/day)/HTM Dose (0.00687 mg/kg/day).

4.4	Spray Drift

Spray drift is always a potential source of exposure to residents nearby to spraying operations.  This is particularly the case with aerial application, but, to a lesser extent, could also be a potential source of exposure from the ground application method employed for amicarbazone.  The Agency has been working with the Spray Drift Task Force, EPA Regional Offices and State Lead Agencies for pesticide regulation and other parties to develop the best spray drift management practices (see the Agency's Spray Drift website for more information at http://www.epa.gov/opp00001/factsheets/spraydrift.htm).  On a chemical by chemical basis, the Agency is now requiring interim mitigation measures for aerial applications that must be placed on product labels/labeling.  The Agency has completed its evaluation of the new database submitted by the Spray Drift Task Force, a membership of U.S. pesticide registrants, and is developing a policy on how to appropriately apply the data and the AgDRIFT computer model to its risk assessments for pesticides applied by air, orchard airblast and ground hydraulic methods.  After the policy is in place, the Agency may impose further refinements in spray drift management practices to reduce off-target drift with specific products with significant risks associated with drift.

It is noted that the 0.46 lb ai/acre application rate for turf was modeled to estimate postapplication residential exposure of children.  As this rate is the same as the maximum agricultural single application rates (0.46 lb ai/A), this scenario is protective of any exposure of farm children via spray drift from agricultural applications of amicarbazone.
5.0		Occupational Exposure

Amicarbazone DF Herbicide (Alternate Brand Name: DINAMIC 70 WDG Herbicide), is a dry flowable (water-dispersible granular) formulation for the control of weeds in turfgrass, including golf courses (i.e., fairways, roughs, tees and approaches), seed production, sod production, and residential and commercial sites (i.e., homes, schools, playgrounds, parks, recreational areas, sports fields and common areas) as well as in tree sites (i.e., tree nurseries and Christmas tree farms).  This product will be applied as a spray after mixing with water or a liquid fertilizer.  Based on information provided by the registrant, this product is intended to be applied only by professional applicators (MRID No. 48237522).  Therefore, the potential for occupational handler and postapplication exposure does exist.

5.1	Occupational Handlers

Based upon the proposed use pattern, HED expects the most highly exposed occupational pesticide handler scenarios to be:

   1) mixing/loading dry flowable for ground applications;
   2) applying sprays via open cab groundboom equipment;
   3) mixing/loading/applying liquids with manually pressurized (low-pressure) handwand; and,
   4) mixing/loading/applying liquids with a backpack sprayer.

Handler exposure is expected to be short- or intermediate-term in duration based on information provided on proposed labels.  Long-term exposures are not expected; therefore, a long-term assessment was not conducted.

Unit Exposures

It is the policy of HED to use the best available data to assess handler exposure.  Sources of generic handler data, used as surrogate data in the absence of chemical-specific data, include the Pesticide Handlers Exposure Database Version 1.1 (PHED 1.1), the Agricultural Handler Exposure Task Force (AHETF) database, and the Outdoor Residential Exposure Task Force (ORETF) database.  Some of these data are proprietary (e.g., AHETF data, MRID No. 44339801), and subject to the data protection provisions of FIFRA.  The standard values recommended for use in predicting handler exposure that are used in this assessment, known as "unit exposures", are outlined in the "Occupational Pesticide Handler Unit Exposure Surrogate Reference Table" (http://www.epa.gov/opp00001/science/handler-exposure-table.pdf), which, along with additional information on HED policy on use of surrogate data, including descriptions of the various sources, can be found at http://www.epa.gov/pesticides/science/handler-exposure-data.html.

For pesticide handlers, it is HED standard practice to present estimates of dermal exposure for "baseline", that is, for workers wearing a single layer of work clothing consisting of a long sleeved shirt, long pants, shoes plus socks and no protective gloves, as well as for "baseline" and the use of protective gloves or other Personal Protective Equipment (PPE) might be necessary to achieve a MOE greater than the LOC.  The proposed product label involved in this assessment directs applicators and other handlers to wear long sleeved shirt and long pants, shoes plus socks, and chemical-resistant gloves.

Body Weight:

The standard body weight for the general population (70 kg) was used for all exposure scenarios covered in this risk assessment.

Dermal Absorption:

Although a dermal absorption rate of 5% was calculated for amicarbazone, HED has concluded that a dermal risk assessment is not needed.

Exposure Frequency:

No data on the number of exposure days per year was provided.  For this risk assessment, it was assumed that handlers would be exposed for less than 6 months per year (i.e. short-/intermediate- term durations).

Equations:

Daily handler exposures are estimated for each applicable handler task with the application rate, the area treated in a day, and the applicable dermal and/or inhalation unit exposure using the following formula:

Daily Exposure (mg ai/day) =
Unit Exposure (mg ai/lb ai handled) x Application Rate (lbs ai/Acre) x Daily Area Treated (area/day)
Where:

      Daily Exposure		=	Amount (mg or ug ai/day) inhaled that is available for inhalation absorption or amount absorbed that is available for dermal absorption;
      Unit Exposure 		=	Unit exposure value (mg or ug ai/lb ai) derived from OPHED;
      Application Rate		=	Normalized application rate based on a logical unit treatment, such as acres, square feet, or gallons.  Maximum values are generally used (lb ai/A, lb ai/sq ft, lb ai/gal);
	Daily Area Treated 	=	Normalized application area based on a logical unit treatment such as acres (A/day), square feet  (sq ft/day), gallons per day (gal/day); and,

The daily dose is calculated by normalizing the daily exposure by body weight and adjusting, if necessary, with an appropriate dermal and/or inhalation absorption factor using the following formula:

Average Daily Dose (mg/kg/day) =
[Daily Exposure (mg ai/day) x Absorption Factor] / Body Weight (kg))

Where:

      Average Daily Dose 		= 	Absorbed dose received from exposure to a pesticide in a given scenario (mg pesticide active ingredient/kg body weight/day);
      Daily Exposure 			=	Amount (mg ai/day) inhaled/absorbed that is available for inhalation/dermal absorption;
      Absorption Factor 		= 	A measure of the amount of chemical that crosses a biological boundary such as the lungs/skin; and
      Body Weight 			= 	Body weight determined to represent the population of interest in a risk assessment (70 kg for amicarbazone).

Risks for each applicable handler scenario are calculated using a MOE, which is a ratio of the NOAEL or LOAEL to the daily dose.  In the case of amicarbazone, a NOAEL was used in the calculation.  All MOE values were calculated using the formula below:

MOE= NOAEL (mg/kg/day) / Daily Dose (mg/kg/day)

Occupational Handler Exposure and Risk Estimates

Table 9 presents the estimated short- and intermediate-term inhalation risks for workers.  All occupational handler scenarios resulted in MOEs greater than the level of concern at the baseline PPE level of protection (i.e. single layer clothing and no respirator).  The MOEs shown in the table are all significantly higher than HED's level of concern of an MOE of 100, with the lowest MOE of 1,300 identified for handlers conducting mixing/loading activities for application to sod farms.

Based on communication with the registrant, the proposed label will prohibit the use of a mechanically pressurized handgun for application to Christmas trees.
Table 9.  Occupational Handler Exposures and Risks Estimates for Amicarbazone.
Exposure Scenario and Product
Crops
Application Rate[a]

Area Treated or Amount Treated
Inhalation Unit Exposure [b]
(mg/lb)
Inhalation Dose [c]
(mg/kg/day)
Inhalation MOE [d]
                                 Mixer/Loader
Ground  -
Dry Flowable
Golf courses

                                     0.46
                                    lb ai/A

                                     40 A

                              0.00896 (Baseline)
                                    (AHETF)
                                    0.00235
                                     2,700

Sod farms (turf), Christmas trees

                                     80 A

                                    0.00471
                                     1,300
                                  Applicator
Open Cab Groundboom
Golf courses

                                     0.46
                                    lb ai/A

                                     40 A

                              0.00034 (Baseline)
                                    (AHETF)
                                   0.0000894
                                    70,000

Sod farms (turf), Christmas trees

                                     80 A

                                   0.000178
                                    35,000
                            Mixer/Loader/Applicator

Backpack Sprayer
Christmas trees
(Ground-Directed)
                                0.023 lb ai/gal

                                    5 gals
                              0.00258 (Baseline)
                                (MRID 44339801)
                                   0.0000042
                                   1,500,000

Turf, golf course, sod farms, parks, recreation and athletic fields

Manually-pressurized Handwand
Turf, Christmas trees
                                0.023 lb ai/gal

                                    5 gals
                                0.03 (Baseline)
                                    (PHED)
                                   0.000049
                                    130,000
Mechanically-pressurized Handgun Sprayer (WDG)

Turf, golf courses
(Broadcast)
                                     0.46
                                    lb ai/A

                                      5 A

                               0.042 (Baseline)
                                    (ORETF)
                                    0.00138
                                     4,500
a.  Application Rate = (70% ai) (1 lbsolid/16 oz) (10.5 oz/A) = 0.46 lb ai/A (1 A/20gal) = 0.023 lb ai/gal.
b.  Occupational Pesticide Handler Unit Exposure Surrogate Reference Table (September 26, 2011).
c.  Inhalation Dose (mg/kg/day) = Inhalation Unit Exposure (mg/lb ai) * Application Rate * Acres Treated or Amount Handled / Body Weight (70 kg).
d.  Inhalation MOE = NOAEL (6.28 mg/kg/day) / Inhalation Dose (mg/kg/day).

5.2	Occupational/Commercial Postapplication Exposure

5.2.1	Postapplication Inhalation Exposure

Based on the Agency's current practices, a quantitative postapplication inhalation exposure assessment was not performed for amicarbazone at this time primarily because it has a low vapor pressure (2.3 x 10[-][8] mm Hg), it is applied at a maximum single application rate of 0.46 lb ai/A and it is not projected to be applied via typically high inhalation exposure application equipment (e.g., airblast and aerial equipment).  However, volatilization of pesticides may be a potential source of postapplication inhalation exposure to individuals nearby to pesticide applications.  The Agency sought expert advice and input on issues related to volatilization of pesticides from its Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (SAP) in December 2009.  The Agency received the SAP's final report on March 2, 2010 (http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html).  The Agency is in the process of evaluating the SAP report and may, as appropriate, develop policies and procedures to identify the need for and, subsequently, the way to incorporate postapplication inhalation exposure into the Agency's risk assessments.  If new policies or procedures are put into place, the Agency may revisit the need for a quantitative postapplication inhalation exposure assessment for amicarbazone.

Although a quantitative occupational postapplication inhalation exposure assessment was not performed, an inhalation exposure assessment was performed for occupational/commercial handlers.  Handler exposure resulting from application of pesticides outdoors is likely to result in higher exposure than postapplication exposure.  Therefore, it is expected that these handler inhalation exposure estimates would be protective of occupational postapplication inhalation exposure scenarios.

5.2.2	Postapplication Dermal Exposure

 Postapplication exposure assessments were not performed because no dermal endpoints were selected.

Restricted Entry Interval
The restricted entry interval (REI) listed on proposed labels is based on the acute toxicity of the technical material.  Amicarbazone exhibits low acute toxicity and is classified as Toxicity Category III for eye irritation and Category IV for acute dermal and dermal irritation.  It is not a dermal sensitizer.  Acute toxicity Category III and IV chemicals require a 12-hour REI.  Therefore, the 12-hour REI which appears on the proposed labels is considered appropriate.


[Federal Register: November 24, 2009 (Volume 74, Number 225)]
[Notices]
[Page 61383-61388]
[DOCID:fr24no09-83]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61021; File No. SR-NYSEArca-2009-103]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
of a Proposed Rule Change Regarding Listing and Trading of RP Short
Duration ETF

November 17, 2009.
    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 November 6, 2009, NYSE Arca, Inc. (``NYSE Arca'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II
and III 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.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    Pursuant to the provisions of Section 19(b)(1) of the Act, NYSE
Arca, through its wholly-owned subsidiary NYSE Arca Equities, Inc.,
proposes to list and trade under NYSE Arca Equities Rule 8.600 the
shares of the RP Short Duration ETF, a series of the Grail Advisors ETF
Trust. The shares of the ETF are collectively referred to herein as the
``Shares.''
    The text of the proposed rule change is available on the Exchange's
Web site at http://www.nyx.com, at the Exchange's principal office and
at the Commission's Public Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
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 those 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 parts of such statements.

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

1. Purpose
    The Exchange proposes to list and trade the Shares of the RP Short
Duration ETF (``ETF'' or ``Fund'') under NYSE Arca Equities Rule 8.600,
which governs the listing and trading of Managed Fund Shares on the
Exchange.\3\ The ETF will be an actively managed exchange traded fund
which is a series of Grail Advisors ETF Trust (``Trust''). The Trust is
registered with the Commission as an investment company.\4\
---------------------------------------------------------------------------

    \3\ The Commission approved NYSE Arca Equities Rule 8.600 and
the listing and trading of certain funds of the PowerShares Actively
Managed Funds Trust on the Exchange pursuant to Rule 8.600 in
Securities Exchange Act Release No. 57619 (April 4, 2008) 73 FR
19544 (April 10, 2008) (SR-NYSEArca-2008-25). The Commission also
previously approved listing and trading on the Exchange, or trading
on the Exchange pursuant to unlisted trading privileges (``UTP'') of
the following actively managed funds under Rule 8.600: Securities
Exchange Act Release Nos. 57626 (April 4, 2008), 73 FR 19923 (April
11, 2008) (SR-NYSEArca-2008-28) (order approving trading pursuant to
UTP of Bear Stearns Active ETF); 57801 (May 8, 2008), 73 FR 27878
(May 14, 2008) (SR-NYSEArca-2008-31) (order approving listing of
twelve actively-managed funds of the WisdomTree Trust); 59826 (April
28, 2009), 74 FR 20512 (May 4, 2009) (SR-NYSEArca-2009-22) (order
approving listing of Grail American Beacon Large Cap Value ETF);
60460 (August 7, 2009), 74 FR 41468 (August 17, 2009) (SR-NYSEArca-
2009-55) (order approving listing of Dent Tactical ETF); 60717
(September 24, 2009), 74 FR 50853 (October 1, 2009) (SR-NYSEArca-
2009-74) (order approving listing of four Grail Advisors RP ETFs).
    \4\ See Registration Statement on Form N-1A for the Trust filed
with the Securities and Exchange Commission on October 7, 2009 (File
Nos. 333-148082 and 811-22154) (the ``Registration Statement''). The
description of the ETF and the Shares contained herein are based on
information in the Registration Statement.
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Description of the Shares and the Fund
    Grail Advisors, LLC is the Fund's investment manager (``Manager'').
RiverPark Advisors, LLC (``RP'') serves as the primary sub-adviser and
Cohanzick Management, LLC (``Cohanzick'') serves as sub-adviser to the
ETF. The Bank of New York Mellon Corporation is the administrator, Fund
accountant, transfer agent and custodian for the ETF. ALPS
Distributors, Inc. serves as the distributor of Creation Units for the
ETF on an agency basis.
RP Short Duration ETF
    The investment objective of the ETF is current income with
potential capital appreciation consistent with the preservation of
capital.
    The ETF invests, under normal circumstances, at least 80% of its
net assets (plus the amount of any borrowings for investment purposes)
in debt securities. These securities include short- and intermediate-
term securities issued by the U.S. Government, its agencies and
instrumentalities, or corporate bonds or notes that Cohanzick, the
ETF's sub-adviser, believes are consistent with the ETF's investment
objective. Under normal circumstances, the ETF invests at least 65% of
its assets in investment grade obligations, including securities issued
or guaranteed by the U.S. Government, its agencies and
instrumentalities. Investment-grade securities are securities rated BBB
or BAA (or higher) by Standard & Poor's or Moody's, respectively, or
the equivalent by a nationally recognized statistical rating
organization rating that security (a ``rating agency''). The ETF may
invest up to 25% of its net assets in high yield securities or below
investment-grade securities, commonly known as ``junk bonds,'' rated BB
or BA (or lower) by Standard & Poor's or Moody's, respectively, or the
equivalent by a rating agency or, if unrated, determined by Cohanzick
to be of comparable quality.
    The ETF expects to maintain an average-weighted effective maturity
of three years or less.\5\ Due to the nature of securities in which the
ETF invests, Cohanzick may make frequent changes to the portfolio and
the ETF's portfolio turnover may be relatively higher than comparable
fixed income funds.
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    \5\ According to the Registration Statement, ``effective''
maturity differs from actual maturity, which may be longer. In
calculating the ``effective'' maturity, Cohanzick estimates the
effect of expected principal payments and call provisions on
securities held in the portfolio. This gives the portfolio managers
additional flexibility in the securities they purchase, but could
also result in more volatility than if the ETF were to calculate and
make investments based on an actual maturity target.
---------------------------------------------------------------------------

    In selecting portfolio securities for the ETF, in addition to
considering economic factors such as the effect of interest rates and
term structure on the ETF's investments, Cohanzick applies a ``bottom-
up'' credit analysis. This means that Cohanzick looks at income-
producing securities one at a time to determine if a security is a
reasonable or an attractive investment opportunity, and if it is
consistent with the ETF's investment objective. The credit analysis may
include, but is not limited to, considering the current yield and
yield-to-maturity of a potential investment relative to similar
securities of a similar rating, positive and/or negative credit events
that have occurred recently or may occur in the future, and fundamental
analysis in determining value versus perceived credit rating or market
pricing.
    The ETF may not invest more than 20% of its net assets in bank
loans. The ETF expects to invest only in U.S. dollar denominated
securities.
    Under adverse market conditions, the ETF may, for temporary
defensive purposes, invest up to 100% of its assets in cash or cash
equivalents, including investment grade short-term obligations. To the
extent the Fund invokes this strategy, its ability to achieve its
investment objective may be affected adversely.
    The Fund will not invest in non-U.S. equity securities.
Investment Policies of the ETF
    The Registration Statement enumerates investment policies which may
be changed with respect to the ETF only by a vote of the holders of a
majority of the ETF's outstanding voting securities. Among these
policies are the following: (1) Regarding diversification, the ETF may
not invest more than 5% of its total assets (taken at market value) in
securities of any one issuer, other

than obligations issued or guaranteed by the U.S. Government, its
agencies and instrumentalities, or purchase more than 10% of the voting
securities of any one issuer, with respect to 75% of the ETF's total
assets; and (2) regarding concentration, the ETF may not invest more
than 25% of its total assets in the securities of companies primarily
engaged in any one industry or group of industries provided that: (i)
This limitation does not apply to obligations issued or guaranteed by
the U.S. Government, its agencies and instrumentalities; and (ii)
municipalities and their agencies and authorities are not deemed to be
industries. The ETF may not invest more than 15% of its net assets in
illiquid securities, including time deposits and repurchase agreements
that mature in more than seven days.\6\ For this purpose, ``illiquid
securities'' are securities that the ETF may not sell or dispose of
within seven days in the ordinary course of business at approximately
the amount at which the ETF has valued the securities.
---------------------------------------------------------------------------

    \6\ This is a non-fundamental investment restriction applicable
to each Fund and may be changed with respect to a Fund by a vote of
a majority of the Board.
---------------------------------------------------------------------------

    In addition to the investment strategies described in the
prospectus for the ETF, the ETF may enter into dollar rolls, delayed
delivery transactions and forward commitment transactions and may buy
and sell ``when issued'' securities, as described in the Registration
Statement. The ETF may invest in mortgage- or other asset-backed
securities. Mortgage-related securities include mortgage pass-through
securities, collateralized mortgage obligations (``CMOs''), commercial
mortgage-backed securities, mortgage dollar rolls, CMO residuals,
stripped mortgage-backed securities (``SMBSs'') and other securities
that directly or indirectly represent a participation in, or are
secured by and payable from, mortgage loans on real property. In
pursuing its individual objectives, the ETF may, to the extent
permitted by their investment objective and policies, purchase and sell
(write) both put options and call options on securities, swap
agreements, securities indexes, and enter into interest rate and index
futures contracts and purchase and sell options on such futures
contracts (``futures options'') for hedging purposes or to seek to
replicate the composition and performance of a particular index, except
that the ETF does not intend to enter into transactions involving
currency futures or options.
    The ETF also may enter into swap agreements with respect to
interest rates and indexes of securities. The ETF may invest in
structured notes. If other types of financial instruments, including
other types of options, futures contracts, or futures options are
traded in the future, the ETF also may use those instruments, provided
that their use is consistent with the ETF's investment objective. The
ETF may, to the extent specified in the Registration Statement,
purchase and sell both put and call options on fixed income or other
securities or indexes in standardized contracts traded on foreign or
domestic securities exchanges, boards of trade, or similar entities, or
on an over-the-counter market, and agreements, sometimes called cash
puts, which may accompany the purchase of a new issue of bonds from a
dealer. The ETF will write call options and put options only if they
are ``covered.''
    The ETF may invest in futures contracts and options thereon with
respect to, but not limited to, interest rates and security indexes.
The ETF will only enter into futures contracts and futures options
which are standardized and traded on a U.S. exchange, board of trade,
or similar entity, or quoted on an automated quotation system.
According to the Registration Statement, neither the Trust nor the Fund
are deemed to be ``commodity pools'' or ``commodity pool operators''
under the Commodity Exchange Act \7\ (``CEA''), and are not subject to
registration or regulation as such under the CEA.
---------------------------------------------------------------------------

    \7\ 7 U.S.C. 1.
---------------------------------------------------------------------------

    The ETF may engage in swap transactions, including, but not limited
to, swap agreements on interest rates or security indexes and specific
securities. The ETF also may enter into options on swap agreements
(``swap options''); purchase or otherwise receive warrants or rights;
enter into repurchase agreements with banks and broker-dealers; and
invest a portion of its assets in cash or cash items pending other
investments or to maintain liquid assets required in connection with
some of the ETF's investments. These cash items may include money
market instruments, such as securities issued by the U.S. Government
and its agencies, bankers' acceptances, commercial paper, and bank
certificates of deposit.
    The ETF may invest in pooled real estate investment vehicles and
other real estate-related investments such as securities of companies
principally engaged in the real estate industry. The ETF may invest in
the securities of other investment companies to the extent permitted by
law. Subject to applicable regulatory requirements, the ETF may invest
in shares of both open- and closed-end investment companies (including
money market funds and ETFs). The ETF also may invest in private
investment funds, vehicles, or structures.
    Commentary .07 to Rule 8.600 provides that, if the investment
adviser to the Investment Company issuing Managed Fund Shares is
affiliated with a broker-dealer, such investment adviser shall erect a
``fire wall'' between the investment adviser and the broker-dealer with
respect to access to information concerning the composition and/or
changes to such Investment Company portfolio.\8\ In addition,
Commentary .07 further requires that personnel who make decisions on
the open-end fund's portfolio composition must be subject to procedures
designed to prevent the use and dissemination of material nonpublic
information regarding the open-end fund's portfolio. Grail Advisors,
LLC is affiliated with a broker-dealer, Grail Securities, LLC, and has
implemented a fire wall with respect to such broker-dealer regarding
access to information concerning the composition and/or changes to a
portfolio. RP and Cohanzick are not affiliated with a broker-dealer.\9\
Any

additional Fund sub-advisers that are affiliated with a broker-dealer
will be required to implement a fire wall with respect to such broker-
dealer regarding access to information concerning the composition and/
or changes to a portfolio.
---------------------------------------------------------------------------

    \8\ An investment adviser to an open-end fund is required to be
registered under the Investment Advisers Act of 1940 (the ``Advisers
Act''). As a result, the investment adviser is subject to the
provisions of Rule 204A-1 under the Advisers Act relating to codes
of ethics. This Rule requires investment advisers to adopt a code of
ethics that reflects the fiduciary nature of the relationship to
clients as well as compliance with other applicable securities laws.
Accordingly, procedures designed to prevent the communication and
misuse of non-public information by an investment adviser must be
consistent with Rule 204A-1 under the Advisers Act.
    \9\ The Exchange represents that Grail Advisors, LLC, as the
investment adviser of the Funds, RP as the primary sub-adviser, and
Cohanzick as a sub-adviser, and their respective related personnel,
are subject to Investment Advisers Act Rule 204A-1. This Rule
specifically requires the adoption of a code of ethics by an
investment adviser to include, at a minimum: (i) Standards of
business conduct that reflect the firm's/personnel fiduciary
obligations; (ii) provisions requiring supervised persons to comply
with applicable Federal securities laws; (iii) provisions that
require all access persons to report, and the firm to review, their
personal securities transactions and holdings periodically as
specifically set forth in Rule 204A-1; (iv) provisions requiring
supervised persons to report any violations of the code of ethics
promptly to the chief compliance officer (``CCO'') or, provided the
CCO also receives reports of all violations, to other persons
designated in the code of ethics; and (v) provisions requiring the
investment adviser to provide each of the supervised persons with a
copy of the code of ethics with an acknowledgement by said
supervised persons. In addition, Rule 206(4)-7 under the Advisers
Act makes it unlawful for an investment adviser to provide
investment advice to clients unless such investment adviser has (i)
adopted and implemented written policies and procedures reasonably
designed to prevent violation, by the investment adviser and its
supervised persons, of the Advisers Act and the Commission rules
adopted thereunder; (ii) implemented, at a minimum, an annual review
regarding the adequacy of the policies and procedures established
pursuant to subparagraph (i) above and the effectiveness of their
implementation; and (iii) designated an individual (who is a
supervised person) responsible for administering the policies and
procedures adopted under subparagraph (i) above.
---------------------------------------------------------------------------

Availability of Information
    The ETF's Web site (http://www.grailadvisors.com), which will be
publicly available prior to the public offering of Shares, will include
a form of the prospectus for the Fund that may be downloaded. The Web
site will include additional quantitative information updated on a
daily basis, including, for the ETF: (1) The prior business day's
reported NAV, mid-point of the bid/ask spread at the time of
calculation of such NAV (the ``Bid/Ask Price''),\10\ and a calculation
of the premium and discount of the Bid/Ask Price against the NAV; and
(2) data in chart format displaying the frequency distribution of
discounts and premiums of the daily Bid/Ask Price against the NAV,
within appropriate ranges, for each of the four previous calendar
quarters. On each business day, before commencement of trading in
Shares in the Core Trading Session \11\ on the Exchange, the Trust will
disclose on its Web site the identities and quantities of the portfolio
of securities and other assets (the ``Disclosed Portfolio'') held by
the ETF that will form the basis for the ETF's calculation of NAV at
the end of the business day.\12\ The Web site and information will be
publicly available at no charge.
---------------------------------------------------------------------------

    \10\ The Bid/Ask Price of the ETF is determined using the
midpoint of the highest bid and the lowest offer on the Exchange as
of the time of calculation of the NAV. The records relating to Bid/
Ask Prices will be retained by the ETF and its service providers.
    \11\ The Core Trading Session is 9:30 a.m. to 4 p.m. Eastern
time.
    \12\ Under accounting procedures followed by the Fund, trades
made on the prior business day (``T'') will be booked and reflected
in NAV on the current business day (``T+1''). Notwithstanding the
foregoing, portfolio trades that are executed prior to the opening
of the Exchange on any business day may be booked and reflected in
NAV on such business day. Accordingly, the Fund will be able to
disclose at the beginning of the business day the portfolio that
will form the basis for the NAV calculation at the end of the
business day.
---------------------------------------------------------------------------

    In addition, for the ETF, an estimated value, defined in NYSE Arca
Equities Rule 8.600 as the ``Portfolio Indicative Value,'' that
reflects an estimated intraday value of the ETF's portfolio, will be
disseminated. The Portfolio Indicative Value will be based upon the
current value for the components of the Disclosed Portfolio and will be
updated and disseminated by one or more major market data vendors at
least every 15 seconds during the Core Trading Session. The
dissemination of the Portfolio Indicative Value, together with the
Disclosed Portfolio, will allow investors to determine the value of the
underlying portfolio of the ETF on a daily basis and to provide a close
estimate of that value throughout the trading day.
    Information regarding market price and volume of the Shares is and
will be continually available on a real-time basis throughout the day
on brokers' computer screens and other electronic services. The
previous day's closing price and trading volume information will be
published daily in the financial section of newspapers. Quotation and
last sale information for the Shares will be available via the
Consolidated Tape Association high-speed line.
    On a daily basis, the Fund will disclose on the its Web site for
each portfolio security or other financial instrument of the Fund the
following information: ticker symbol (if applicable), name of security
or financial instrument, number of shares or dollar value of financial
instruments held in the portfolio, and percentage weighting of the
security or financial instrument in the portfolio.
    Investors can also obtain the Trust's Statement of Additional
Information (``SAI''), the Fund's Shareholder Reports, and its Form N-
CSR and Form N-SAR, filed twice a year. The Trust's SAI and Shareholder
Reports are available free upon request from the Trust, and those
documents and the Form N-CSR and Form N-SAR may be viewed on-screen or
downloaded from the Commission's Web site at http://www.sec.gov.
Information regarding market price and trading volume of the Shares is
and will be continually available on a real-time basis throughout the
day on brokers' computer screens and other electronic services.
Information regarding the previous day's closing price and trading
volume information will be published daily in the financial section of
newspapers.
    Additional information regarding the Shares and the Fund, including
investment strategies, risks, creation and redemption procedures, fees,
portfolio holdings disclosure policies, distributions and taxes is
included in the Registration Statement. All terms relating to the Fund
that are referred to, but not defined in, this proposed rule change are
defined in the Registration Statement.
Initial and Continued Listing
    The Shares will be subject to NYSE Arca Equities Rule 8.600(d),
which sets forth the initial and continued listing criteria applicable
to Managed Fund Shares. The Exchange represents that, for initial and/
or continued listing, the Shares must be in compliance with Rule 10A-3
\13\ under the Exchange Act, as provided by NYSE Arca Equities Rule
5.3. A minimum of 100,000 Shares will be outstanding at the
commencement of trading on the Exchange. The Exchange will obtain a
representation from the issuer of the Shares that the net asset value
per Share will be calculated daily and that the net asset value and the
Disclosed Portfolio will be made available to all market participants
at the same time.
---------------------------------------------------------------------------

    \13\ See 17 CFR 240.10A-3.
---------------------------------------------------------------------------

Trading Halts
    With respect to trading halts, the Exchange may consider all
relevant factors in exercising its discretion to halt or suspend
trading in the Shares of the Fund. Shares of the Fund will be halted if
the ``circuit breaker'' parameters in NYSE Arca Equities Rule 7.12 are
reached. Trading may be halted because of market conditions or for
reasons that, in the view of the Exchange, make trading in the Shares
inadvisable. These may include: (1) The extent to which trading is not
occurring in the securities comprising the Disclosed Portfolio and/or
the financial instruments of the Fund; or (2) whether other unusual
conditions or circumstances detrimental to the maintenance of a fair
and orderly market are present. Trading in the Shares will be subject
to NYSE Arca Equities Rule 8.600(d)(2)(D), which sets forth
circumstances under which Shares of the Fund may be halted.
Trading Rules
    The Exchange deems the Shares to be equity securities, thus
rendering trading in the Shares subject to the Exchange's existing
rules governing the trading of equity securities. Shares will trade on
the NYSE Arca Marketplace from 4 a.m. to 8 p.m. Eastern time in
accordance with NYSE Arca Equities Rule 7.34 (Opening, Core, and Late
Trading Sessions). The Exchange has appropriate rules to facilitate
transactions in the Shares during all trading sessions. The minimum
trading

increment for Shares on the Exchange will be $0.01.
Surveillance
    The Exchange intends to utilize its existing surveillance
procedures applicable to derivative products (which includes Managed
Fund Shares) to monitor trading in the Shares. The Exchange represents
that these procedures are adequate to properly monitor Exchange trading
of the Shares in all trading sessions and to deter and detect
violations of Exchange rules and applicable Federal securities laws.
    The Exchange's current trading surveillance focuses on detecting
securities trading outside their normal patterns. When such situations
are detected, surveillance analysis follows and investigations are
opened, where appropriate, to review the behavior of all relevant
parties for all relevant trading violations.
    The Exchange may obtain information via the Intermarket
Surveillance Group (``ISG'') from other exchanges who are members of
ISG.\14\
---------------------------------------------------------------------------

    \14\ For a list of the current members of ISG, see http://
www.isgportal.org. The Exchange notes that not all of the components
of the Disclosed Portfolio for the Fund may trade on exchanges that
are members of ISG.
---------------------------------------------------------------------------

    In addition, the Exchange also has a general policy prohibiting the
distribution of material, non-public information by its employees.
Information Bulletin
    Prior to the commencement of trading, the Exchange will inform its
ETP Holders in an Information Bulletin (``Bulletin'') of the special
characteristics and risks associated with trading the Shares.
Specifically, the Bulletin will discuss the following: (1) The
procedures for purchases and redemptions of Shares in Creation Unit
aggregations (and that Shares are not individually redeemable); (2)
NYSE Arca Equities Rule 9.2(a), which imposes a duty of due diligence
on its ETP Holders to learn the essential facts relating to every
customer prior to trading the Shares; (3) the risks involved in trading
the Shares during the Opening and Late Trading Sessions when an updated
Portfolio Indicative Value will not be calculated or publicly
disseminated; (4) how information regarding the Portfolio Indicative
Value is disseminated; (5) the requirement that ETP Holders deliver a
prospectus to investors purchasing newly issued Shares prior to or
concurrently with the confirmation of a transaction; and (6) trading
information.
    In addition, the Bulletin will reference that the Fund is subject
to various fees and expenses described in the Registration Statement.
The Bulletin will discuss any exemptive, no-action, and interpretive
relief granted by the Commission from any rules under the Exchange Act.
The Bulletin will also disclose that the NAV for the Shares will be
calculated after 4 p.m. Eastern time each trading day.
2. Statutory Basis
    The basis under the Act for this proposed rule change is the
requirement under Section 6(b)(5) \15\ that an exchange have rules that
are designed to prevent fraudulent and manipulative acts and practices,
to promote just and equitable principles of trade, to remove
impediments to, and perfect the mechanism of a free and open market
and, in general, to protect investors and the public interest. The
Exchange believes that the proposed rule change will facilitate the
listing and trading of an additional type of exchange-traded products
that will enhance competition among market participants, to the benefit
of investors and the marketplace. In addition, the listing and trading
criteria set forth in NYSE Arca Equities Rule 8.600 are intended to
protect investors and the public interest.
---------------------------------------------------------------------------

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

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 that is not necessary or appropriate
in furtherance of the purposes of the Act.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve the proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.
    The Exchange has requested accelerated approval of this proposed
rule change prior to the 30th day after the date of publication of the
notice in the Federal Register. The Commission is considering granting
accelerated approval of the proposed rule change at the end of a 15-day
comment period.

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-NYSEArca-2009-103 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2009-103. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make publicly available. All
submissions should refer to File

Number SR-NYSEArca-2009-103 and should be submitted on or before
December 9, 2009.
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    \16\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-28118 Filed 11-23-09; 8:45 am]

BILLING CODE 8011-01-P