[Federal Register Volume 80, Number 209 (Thursday, October 29, 2015)]
[Notices]
[Pages 66615-66616]
[FR Doc No: 2015-27577]

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

DEPARTMENT OF TRANSPORTATION

Office of the Secretary of Transportation

[Docket No. DOT-OST-2015-0139]

Proposed Agency Information Collection Request; Vendor Invoice
Submission Pilot

AGENCY: U.S. Department of Transportation (DOT).

ACTION: Notice with request for comments.

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

SUMMARY: The DOT invites the public and other Federal agencies to
comment on a proposed information collection request concerning a pilot
program to evaluate new processes and procedures for vendor invoice
submission. DOT will submit the proposed information collection request
to the Office of Management and Budget (OMB) for review, as required by
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506 (c)(2)(A)).
This notice sets forth new processes and procedures for vendors that
submit invoices and receive payments from DOT Operating Administrations
(OAs). DOT's objective is to improve efficiency and reduce manual
processing through the use of electronic invoicing for vendors. This
electronic invoicing process is currently used by DOT's grantee
community and the Department and would like to pilot an automated
invoicing process utilized by DOT grantees that would allow invoices to
be submitted electronically. Automating and simplifying the DOT vendor
payment process will save both the vendor and the Federal Government
time and expense that come with paper-based invoice submission and
payment administration.

DATES: Comments must be submitted on or before December 28, 2015.

FOR FURTHER INFORMATION CONTACT: Requests for additional information
should be directed to US Department of Transportation, Office of
Financial Management, B-30, Room W93-431, 1200 New Jersey Avenue SE.,
Washington DC 20590-0001, Gayle Sienicki<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Title: Notice of Procedures for Vendor Invoice Submission Pilot.
    OMB Control Number: 2105-0139.
    Type of Request: New information collection.
    Background: This notice sets forth new processes and procedures for
vendors that submit invoices and receive payments from DOT Operating
Administrations (OAs). The vendors involved in the pilot must meet the
following requirements to participate--
     Vendors will need to have electronic internet access to
register in the Delphi eInvoicing system.
     Vendors will submit invoices electronically and DOT OAs
must process invoices electronically.
     The identities of system users must be verified prior to
receiving access to the Delphi eInvoicing system. Prospective Users
must complete a user request form and provide the following
information: full name, work address, work phone number, work email
address, home address and home phone number. Prospective users must
present the completed form to a Notary Public for verification.
Prospective users will then return the notarized form to DOT to receive
their login credentials.
    Affected Public: DOT Vendors.
    Total Estimated Number of Respondents: 255.
    Total Estimated Number of Responses: 2603.
    Estimated Total Annual Burden Hours: 5206 (initial registration
only).
    Frequency of Collection: One time.
    Annual Estimated Total Annual Burden Costs: $52,060.

ADDRESSES: Send comments regarding the burden estimate, including
suggestions for reducing the burden, to US Department of
Transportation, Office of Financial Management, B-30, Room W93-431,
1200 New Jersey Avenue SE., Washington DC 20590-0001, Gayle Sienicki
(202) 366-0448<EMAIL_ADDRESS>    Comments: Comments are invited on: whether the proposed collection
of information is necessary for the proper performance of the functions
of the Department, including whether the information will have
practical utility; the accuracy of the Department's estimate of the
burden of the proposed information collection; ways to enhance the
quality, utility and clarity of the information to be collected; and
ways to

minimize the burden of the collection of information on respondents,
including the use of automated collection techniques or other forms of
information technology.

    Authority:  The Paperwork Reduction Act of 1995, 44 U.S.C. 3501-
3520, as amended.

    Issued in Washington, DC, on October 22, 2015.
David Rivait,
Deputy Chief Financial Officer, Department of Transportation.
[FR Doc. 2015-27577 Filed 10-28-15; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register Volume 80, Number 63 (Thursday, April 2, 2015)]
[Notices]
[Page 17742]
[FR Doc No: 2015-07637]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9925-64-Region 1]

2015 Annual Meeting of the Ozone Transport Commission

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of meeting.

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

SUMMARY: The United States Environmental Protection Agency (EPA) is
announcing the 2015 Annual Meeting of the Ozone Transport Commission
(OTC). This OTC meeting will explore options available for reducing
ground-level ozone precursors in a multi-pollutant context. The
Commission will be evaluating potential measures and considering
actions in areas such as performance standards for electric generating
units (EGUs) on high electric demand days, oil and gas boilers serving
EGUs, small natural gas boilers, stationary generators, energy
security/energy efficiency, architectural industrial and maintenance
coatings, consumer products, institution commercial and industrial
(ICI) boilers, vapor recovery at gas stations, large above ground
storage tanks, seaports, aftermarket catalysts, lightering, and non-
road idling.

DATES: The meeting will be held on June 4, 2015 starting at 9:30 a.m.
and ending at 4:00 p.m.
    Location: Holiday Inn Princeton hotel located at 100 Princeton Way,
Princeton, NJ 085401;<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: For documents and press inquiries
contact: Ozone Transport Commission, 444 North Capitol Street NW.,
Suite 322, Washington, DC 20001;<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Web site:  http://www.otcair.org .

SUPPLEMENTARY INFORMATION: The Clean Air Act Amendments of 1990 contain
at Section 184 provisions for the Control of Interstate Ozone Air
Pollution. Section 184(a) establishes an Ozone Transport Region (OTR)
comprised of the States of Connecticut, Delaware, Maine, Maryland,
Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode
Island, Vermont, parts of Virginia and the District of Columbia. The
purpose of the OTC is to deal with ground-level ozone formation,
transport, and control within the OTR.
    Type of Meeting: Open.
    Agenda: Copies of the final agenda will be available from the OTC
office<PHONE_NUMBER>; by email<EMAIL_ADDRESS>or via the OTC Web
site at http://www.otcair.org.

    Dated: March 11, 2015.
Deborah A. Szaro,
Acting Regional Administrator, EPA Region 1.
[FR Doc. 2015-07637 Filed 4-1-15; 8:45 am]
BILLING CODE CODE 6560-50-P


1990 Study

                                    2.2E-7

                                     0.12

                                    5.5E+5

                                  1995 Study

                                    4.4E-8

                                    2.5E+6

Oral Hand-to-Mouth

                                   1990 Study

                                    7.5E-7

                                     0.12

                                    1.6E+5

                                  1995 Study

                                    1.6E-7

                                    7.5E+5

Oral Object-to-Mouth

                                   1990 Study

                                    4.7E-8

                                     0.12

                                    2.6E+6

                                  1995 Study

                                    1.0E-8

                                    1.2E+7

Inhalation

                                   1990 Study

                                    1.3E-4

                                     0.12

                                      920

                                  1995 Study

                                    4.7E-5

                                     2,600

Total:

                                   1990 Study

                                    1.3E-4

                                     0.12

                                      920

                                  1995 Study

                                    4.7E-5

                                     2,600

Adult Combined Handler and Post-Application Dermal and Inhalation Exposure and Risk

Handler Dermal

                                     PHED

                                    2.4E-8

                                     0.12

                                    5.0E+6

Handler Inhalation

                                     PHED

                                    2.4E-8

                                     0.12

                                    5.0E+6

Post-application Dermal

                                   1990 Study

                                    1.6E-7

                                     0.12

                                    7.5E+5

                                  1995 Study

                                    2.9E-8

                                    4.1E+6

Post-application Inhalation

                                   1990 Study

                                    8.4E-5

                                     0.12

                                     1,400

                                  1995 Study

                                    3.0E-5

                                     4,000

Total:

                             PHED & 1990 Study

                                    8.4E-5

                                     0.12

                                     1,400

                            PHED & 1995 Study

                                    3.0E-5

                                     4,000
[1]  1990 Study:	Evaluation of Avert Prescription Treatment 310 Residual Study in Air, Food and on Surfaces, November 8, 1990 (MRID No. 44665901)
   1995 Study:	Evaluation of Indoor Exposure to a Crack and Crevice Application of Whitmire Avert Crack and Crevice Prescription Treatment 310 and Prescription TC 93A Bait, October 27, 1995 (MRID No. 44147801)

6.3	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 abamectin.  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.

Although a quantitative residential post-application inhalation exposure assessment was not performed as a result of pesticide drift from neighboring treated agricultural fields, an inhalation exposure assessment was performed for flaggers.  This exposure scenario is representative of a worse case inhalation (drift) exposure and may be considered protective of most outdoor agricultural and commercial post-application inhalation exposure scenarios.

Sometimes the risk presented from direct application of lawn treatment products can supersede potential risk concerns from agricultural spray drift.  However, in the case of abamectin, agricultural use rates are higher than those for residential lawn treatment, and the assessment of post-application risks for abamectin lawn products did not include a dermal exposure component.

7.0	Aggregate Risk Assessments and Risk Characterization

In accordance with the FQPA, HED must consider and aggregate (add) pesticide exposures and risks from three major sources: food, drinking water, and residential exposures.  In an aggregate assessment, exposures from relevant sources are added together and compared to quantitative estimates of hazard (e.g., a NOAEL or PAD), or the risks themselves can be aggregated.  When aggregating exposures and risks from various sources, HED considers both the route and duration of exposure.

7.1	Acute Aggregate Risk

The acute aggregate risk assessment takes into account exposure estimates from dietary consumption of abamectin (food and drinking water).  The acute aggregate food and drinking water assessment results are presented in Section 5.2 above.  The most highly exposed subgroup is all infants (<1 year old) at 30% of the aPAD, which is below the level of concern.

7.2	Short- and Intermediate-Term Aggregate Risk

The short-/intermediate-term aggregate risk assessment estimates risks likely to result from exposure to abamectin residues from food, drinking water, and residential pesticide uses.  High-end estimates of residential exposure are used, while average values are used for food and drinking water exposure.

A short-/intermediate-term risk assessment is required for adults because there are potential residential handler and post-application exposures from the crack and crevice use.  In addition, a short-/intermediate-term risk assessment is required for infants and children because there is a residential post-application exposure scenario for crack and crevice treatment.  The ingestion of granules (from the lawn treatment for fire ants) is not included in the aggregate assessment because it is considered to be a one-time, episodic event, rather than occurring for several days (or several months).

The results of the short-/intermediate-term aggregate assessments are presented in Table 7.2.  HED is generally not concerned if the MOEs remain above the LOC, which for this assessment is 300.  The MOEs for all scenarios are greater than 300, and therefore, are not of concern.

Table 7.2.  Short-Term and/or Intermediate-Term Aggregate Risk Calculations
                      (Inhalation/Oral/Dermal Endpoints and NOAELs are the Same.)

Population
                     Short- or Intermediate-Term Scenario

NOAEL
mg/kg/day
LOC[1]
Max Allowable
Exposure[2]
mg/kg/day
Average
Food & Water
Exposure
mg/kg/day
Residential Exposure[3]
mg/kg/day
Aggregate MOE
(food and
residential)[4]
U.S. Population
0.12
300
0.0004
0.000070
0.000030
1200
Children (1-2 years old)
0.12
300
0.0004
0.000200
0.000047
500
[1] The LOC includes the standard inter- and intra- species uncertainty factors (UFA and UFH, respectively) totaling 100, and an additional factor of 3x for the steepness of the dose-response curve and the severity of effects.
[2] Maximum Allowable Exposure (mg/kg/day) = NOAEL/LOC
[3] Residential Exposure = [Oral exposure + Dermal exposure + Inhalation exposure].  Refer to Table 6.2.2 for residential exposure values used in the aggregate assessment.
[4] Aggregate MOE = [NOAEL  (Avg Food & Water Exposure + Residential Exposure)]

7.3	Long-Term (Chronic) Aggregate Risk

The chronic aggregate risk assessment takes into account average exposure estimates from dietary consumption of abamectin (food and drinking water) and residential uses.  However, due to the use patterns, no chronic residential exposures are expected.  Therefore, the chronic aggregate risk assessment will consider exposure from food and drinking water only.

The chronic aggregate food and drinking water assessment results are presented in Section 5.2 above.  The most highly exposed subgroup is children 1-2 years old at 50% of the cPAD, which is below the level of concern.

7.4	Cancer Risk

Abamectin is classified as "not likely to be carcinogenic to humans" based on the absence of a significant increase in tumor incidence in two adequate rodent carcinogenicity studies.

8.0	Cumulative Risk Characterization/Assessment

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to abamectin and any other substances and abamectin does not appear to produce a toxic metabolite produced by other substances.  For the purposes of this tolerance action, therefore, EPA has not assumed that abamectin has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.

9.0	Occupational Exposure/Risk Pathway

Reference:	Abamectin.  Occupational and Residential Exposure Assessment for Proposed IR-4 Foliar Uses on Bulb Onions (Subgroup 3-07A), Chives, and Dry Beans, D380797, N. Tsaur, 3/29/11.

Occupational handler exposure to abamectin is expected for individuals involved in foliar applications to bulb onions (subgroup 3-07A), chives, and dry beans (mixing, loading, and applying).  Handler exposure is expected to be short- or intermediate-term based on information provided on the proposed label.

Agricultural workers performing typical post-application activities (e.g. scouting, irrigation, transplanting/harvesting, etc.) may receive short- and intermediate-term exposure to abamectin residues.

9.1	Short-/Intermediate-Term Handler Risk

Handler's exposure and risk were estimated for the following scenarios: mixer/loaders (mixing/ loading liquid to support groundboom or aerial applications); flaggers (flagging to support aerial application); applicators (applying sprays with groundboom or aerial equipment with enclosed cockpit).

The minimum level of PPE for handlers is based on acute toxicity for the end-use product.  All three labels state that all handlers must wear the proper PPE: coveralls worn over a short-sleeved shirt with short pants, chemical resistant gloves, chemical-resistant footwear with socks, protective eyewear, chemical-resistant headgear for overhead exposure, and a chemical resistant apron when cleaning equipment, mixing, or loading.  The Registration Division (RD) is responsible for ensuring that PPE listed on the label is in compliance with the Worker Protection Standard (WPS).

No chemical-specific handler exposure data were submitted in support of this Section 3 registration.  In accordance with HED's Exposure Science Advisory Council (SAC) policy, exposure data from the Pesticide Handlers Exposure Database (PHED), Version 1.1, as presented in PHED Surrogate Exposure Guide (8/98), were used with other HED standard values for acres treated per day, body weight, and the level of personal protective equipment to assess handler exposures.

Exposure/risk assessments were performed using applicable toxicity endpoints.  Daily dermal and inhalation exposures were calculated separately, applying a dermal absorption factor of 1%, and an inhalation absorption factor of 100%.  The dermal and inhalation exposures were added together and compared to the common NOAEL of 0.12 mg/kg/day (from combined data from three reproduction studies and two developmental neurotoxicity studies where the LOAEL = 0.2 mg/kg/day based on decreased pup body weight) to determine the handler risk (from total dermal and inhalation exposure) for short- and intermediate-term exposures.

The total MOEs (when gloves are added to the mixing/loading scenarios) range from 750 (for open mixing/loading of liquid to support aerial application with PPE including gloves) to 9100 (for applying sprays via aerial equipment (enclosed cockpit).  These MOEs do not exceed HED's level of concern of 300 (when gloves are added to the mixing/loading scenarios).

Assumptions and estimates for occupational handler exposure are summarized in Tables 9.1.1 and 9.1.2.

Table 9.1.1.  Abamectin Short- and Intermediate-Term Agricultural Occupational Exposures and Risks (Baseline: single layer, no gloves, no respirator).
                               Exposure Scenario
                             Application Rate [a]
                            Area Treated Daily [b]
                                    Dermal
                                    UE [c]
                               Inhalation UE [c]
                                Dermal Dose [d]
                                 Dermal MOE e
                              Inhalation Dose [f]
                               Inhalation MOE g
                                Combined Dose h
                            ST/IT Combined MOE [i]

                                    lb ai/A
                                     acres
                                   mg/lb ai
                                   mg/lb ai
                                   mg/kg/day
                                   LOC = 300
                                   mg/kg/day
                                   LOC = 300
                                   mg/kg/day
                                   LOC = 300
                                 Mixer/Loader
                           Mixing/Loading Liquid for
                            Groundboom Applications
                                    0.0191
                                      80
                                      2.9
                                    0.0012
                                    0.00074
                                      160
                                   0.000031
                                     3900
                                    0.00077
                                      160
                           Mixing/Loading Liquid for
                              Aerial Applications
                                    0.0191
                                      350
                                      2.9
                                    0.0012
                                    0.0032
                                      37
                                    0.00013
                                      900
                                    0.0034
                                      36
                                    Flagger
                                 Flagging for
                              Aerial Application
                                    0.0191
                                      350
                                     0.011
                                    0.00035
                                   0.000012
                                     9800
                                   0.000039
                                     3100
                                   0.000051
                                     2300
                                  Applicator
                              Applying Sprays via
                             Groundboom Equipment
                                    0.0191
                                      80
                                     0.014
                                    0.00074
                                   0.0000036
                                    34,000
                                   0.000019
                                     6000
                                   0.000022
                                     5300
                              Applying Sprays via
                              Aerial Equipment j
                                    0.0191
                                      350
                                    0.0050
                                    0.00007
                                   0.0000056
                                    21,000
                                   0.0000076
                                    16,000
                                   0.000013
                                     9100
a  Application Rates based on maximum proposed use rates for abamectin labels: EPA Reg. No. 100-898, EPA Reg. No. 100-1351, EPA Reg. No. 100-1154.
b  Acres Treated Per Day is taken from Exposure Science Advisory Council (ExpoSAC) Policy No. 9.1.
c  UE = Unit Exposures based on PHED Version 1.1 data.  Baseline = single layer, no gloves, no respirator.
d  Dermal Dose (mg/kg/day) = application rate (lb ai/acre) x amount handled /day (acres/day) x daily unit exposure (mg/lb ai) x absorption factor (1%) / body weight (60 kg).
e  Dermal Margin of Exposure = NOAEL (mg/kg/day) / Dermal Dose (mg/kg/day). Level of concern = 300. Short- and Intermediate-Term NOAEL = 0.12 mg/kg/day.
f  Inhalation Dose (mg/kg/day) = application rate (lb ai/acre) x amount handled /day (acres/day) x daily unit exposure (mg/lb ai) x absorption factor (100%) / body weight (60 kg).
g  Inhalation Margin of Exposure = NOAEL (mg/kg/day) / Inhalation Dose (mg/kg/day). Level of concern = 300. Short- and Intermediate-Term NOAEL = 0.12 mg/kg/day.
h  Combined Dose = Dermal Dose (mg/kg/day) + Inhalation Dose (mg/kg/day).
i  Short- and Intermediate-Term Combined Margin of Exposure = NOAEL (mg/kg/day) / Combined Dose (mg/kg/day). Level of concern = 300. ST/IT NOAEL = 0.12 mg/kg/day.
j  Only engineering control (enclosed cockpit) data are available to assess risks to handlers operating aircraft (enclosed cab, no gloves, no respirator).

Table 9.1.2.  Abamectin Short- and Intermediate-Term Agricultural Occupational Exposures and Risks (PPE: single layer, gloves, no respirator).
                               Exposure Scenario
                             Application Rate [a]
                            Area Treated Daily [b]
                                    Dermal
                                    UEs [c]
                              Inhalation UEs [c]
                                Dermal Dose [d]
                                 Dermal MOE e
                              Inhalation Dose [f]
                               Inhalation MOE g
                                Combined Dose h
                            ST/IT Combined MOE [i]

                                    lb ai/A
                                     acres
                                   mg/lb ai
                                   mg/lb ai
                                   mg/kg/day
                                   LOC = 300
                                   mg/kg/day
                                   LOC = 300
                                   mg/kg/day
                                   LOC = 300
                                 Mixer/Loader
                           Mixing/Loading Liquid for
                            Groundboom Applications
                                    0.0191
                                      80
                                     0.023
                                    0.0012
                                   0.0000059
                                    20,000
                                   0.000031
                                     3900
                                   0.000036
                                     3300
                           Mixing/Loading Liquid for
                              Aerial Applications
                                    0.0191
                                      350
                                     0.023
                                    0.0012
                                   0.000026
                                     4700
                                    0.00013
                                      900
                                    0.00016
                                      750
a  Application Rates based on maximum proposed use rates for abamectin labels: EPA Reg. No. 100-898, EPA Reg. No. 100-1351, EPA Reg. No. 100-1154.
b  Acres Treated Per Day is taken from Exposure Science Advisory Council (ExpoSAC) Policy No. 9.1.
c  UE = Unit Exposures based on PHED Version 1.1 data.  PPE = single layer, gloves, no respirator.
d  Dermal Dose (mg/kg/day) = application rate (lb ai/acre) x amount handled /day (acres/day) x daily unit exposure (mg/lb ai) x absorption factor (1%) / body weight (60 kg).
e  Dermal Margin of Exposure = NOAEL (mg/kg/day) / Dermal Dose (mg/kg/day). Level of concern = 300. Short- and Intermediate-Term NOAEL = 0.12 mg/kg/day.
f   Inhalation Dose (mg/kg/day) = application rate (lb ai/acre) x amount handled /day (acres/day) x daily unit exposure (mg/lb ai) x absorption factor (100%) / body weight (60 kg).
g  Inhalation Margin of Exposure = NOAEL (mg/kg/day) / Inhalation Dose (mg/kg/day). Level of concern = 300. Short- and Intermediate-Term NOAEL = 0.12 mg/kg/day.
h  Combined Dose = Dermal Dose (mg/kg/day) + Inhalation Dose (mg/kg/day).
i  Short- and Intermediate-Term Combined Margin of Exposure = NOAEL (mg/kg/day) / Combined Dose (mg/kg/day). Level of concern = 300. ST/IT NOAEL = 0.12 mg/kg/day.

9.2	Occupational Post-Application Exposures and Risks

Short-/Intermediate-/Long-Term Post-Application Risk

There is a potential for post-application exposure to scouts, harvesters and other field workers following foliar application to agricultural crops.  Chemical-specific post-application exposure data were not provided.  The transfer coefficients used in this assessment are from the transfer coefficient standard operating procedure (SOP) developed by HED's Science Advisory Council (SAC) for Exposure (Exposure SAC Policy No. 3.1, "Agricultural Transfer Coefficients," August 2000) using proprietary data from the Agricultural Re-entry Task Force (ARTF) database).  Also, this assessment uses HED's default assumption that 20% of the application rate is available for transfer on the day of treatment, and that the residue dissipates at a rate of 10% per day thereafter.

The short- and intermediate-term MOEs for post-application exposure on day 0 (12 hours after application) range from 840 to 21,000.  Since these calculated MOEs are greater than 300 on the day of application, they do not exceed HED's level of concern.  A summary of the post-application exposure and risk assessment is presented in Table 9.2.

HED's post-application exposure estimates are based on surrogate data.  The transfer coefficients are considered to be central tendency.  Maximum application rates were used in this assessment.  Overall, the post-application risks are characterized as being central to high-end estimates.

The post-application exposure associated with agricultural crops is summarized in Table 9.2.  All scenarios resulted in MOEs greater than 300 (ranging from 840 to 21,000) on day 0 (12 hours after application) and, therefore, are not of concern to HED.

Table 9.2.  Short- and Intermediate-Term Post-Application Exposures and Risk for Abamectin.
                              Crop Grouping/Crop
                                   Activity
                                   Transfer
                                  Coefficient
                             Days After Treatment
                                   DFR [a]
                             Daily Dermal Dose [b]
                                    Dermal
                                    MOE [c]

                                   ug/cm[2]
                                   mg/kg/day
                                   LOC = 300
                                  Bulb Onions
                               (Subgroup 3-07A)
                             irrigation, scouting,
                            thinning, hand weeding
                                      300
                                       0
                                  (12 hours)
                                    0.0429
                                   0.000017
                                     7,000

                                    Chives
                           hand harvesting, thinning
                                     2500
                                       0
                                  (12 hours)
                                    0.0429
                                   0.000143
                                      840

                             irrigation, scouting
                                     1500
                                       0
                                  (12 hours)
                                    0.0429
                                   0.000086
                                     1,400

                                 hand weeding
                                      500
                                       0
                                  (12 hours)
                                    0.0429
                                   0.000029
                                     4,200
                                   Dry Beans
                                hand harvesting
                                     2500
                                       0
                                  (12 hours)
                                    0.0429
                                   0.000143
                                      840

                             irrigation, scouting
                                     1500
                                       0
                                  (12 hours)
                                    0.0429
                                   0.000086
                                     1,400

                                 hand weeding
                                      100
                                       0
                                  (12 hours)
                                    0.0429
                                   0.0000057
                                    21,000
a	DFR (ug/cm[2]) = application rate (lb ai/acre) x fraction of application rate dislodgeable on day 0 (20%) x (1 - fraction of residue that dissipates daily 10%)t x 4.54E8 ug/lb x 2.47E-8 acre/cm2.
b	Short-/Intermediate-Term Daily Dermal Dose = [DFR (ug/cm[2]) x Transfer Coefficient x 0.001 mg/ug x 8 hrs/day x dermal absorption 1%]  body weight (60 kg adult).
c	Short-/Intermediate-Term MOE = NOAEL (mg/kg/day)/Daily Dermal Dose (mg/kg/day). ST/IT NOAEL = 0.12 mg/kg/day.

Restricted Entry Interval
Since both short- and intermediate-term post-application risks were not a concern on day 0 (12 hours following application), the REI is based on the acute toxicity of abamectin technical material.  Under WPS for Agricultural Pesticides, active ingredients classified as acute Toxicity Category III or IV for Acute Dermal, Eye Irritation, and Primary Skin Irritation are assigned a 12-hour REI.  Thus, the 12-hour REI on the proposed labels are acceptable.

Occupational Post-Application Inhalation Exposure
Based on the Agency's current practices, a quantitative occupational post-application inhalation exposure assessment was not performed for abamectin at this time.  However, there are multiple potential sources of post-application inhalation exposure to individuals performing post-application activities in previously treated fields.  These potential sources include volatilization of pesticides and resuspension of dusts and/or particulates that contain pesticides.  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) and is in the process of evaluating the SAP report as well as available post-application inhalation exposure data generated by the Agricultural Reentry Task Force.  The Agency may, as appropriate, develop policies and procedures to identify the need for and, subsequently, the way to incorporate occupational post-application 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 occupational post-application inhalation exposure assessment for abamectin.

10.0		References

 N. Dodd, 5/18/11, DP#380795, Abamectin.  Petition for Tolerances/Section 3 Registration on the Bulb Onion Subgroup 3-07A, Chives, and Dry Beans.  Summary of Analytical Chemistry and Residue Data.

N. Dodd, 6/13/11, DP#380796, Abamectin.  Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for the Section 3 on Bulb Onions, Chives, and Dry Beans.

A. Grube, 10/21/10, DP#382732, Usage Report Package in Support of Registration for the Insecticide Abamectin (122804).

N. Tsaur, 3/29/11, DP#380797, Abamectin.  Occupational and Residential Exposure Assessment for Proposed IR-4 Foliar Uses on Bulb Onions (Subgroup 3-07A), Chives, and Dry Beans.

J. Arthur, 10/29/04, DP#306906, Abamectin: Occupational and Residential Risk Assessment to Support Section 3 Request for Uses on Various Food Crops and Food-Handling Establishments.

G. Orrick, 1/31/11, DP#380524, Abamectin: Drinking Water Exposure Assessment for Proposed Section 3 New Uses on Chives, Dried Beans, and the Bulb Onion Subgroup 3-07A.

N. Dodd et al., 3/11/09, DP#362615, Abamectin.  Revised Human Health Risk Assessment for Proposed Uses on Pasture and Rangeland Grass, Stone Fruit Crop Group 12, Tree Nut Crop Group 14, Pistachio, Tuberous and Corm Vegetables Subgroup 1C and Request for Cattle Ear Tag Use.
                       Appendix A:	Toxicology Assessment

               Table A.1.  Acute Toxicity of Abamectin Technical
Guideline No.
Study Type
MRID #
Results
Toxicity Category
870.1100
Acute Oral - rat
(sesame oil vehicle)
006894
LD50 = 13.6 mg/kg
 I
870.1100
Acute Oral - rat
(methyl cellulose vehicle)
45607202
LD50=214-232 mg/kg
 II
870.1200
Acute Dermal - rabbit
00255978
LD50 = 2000 mg/kg
 III
870.1300
Acute Inhalation - rat
45623501
LC50 =<0.21 mg/L (nose only)
 I
870.2400
Primary Eye  Irritation
45063501
not an irritant
 IV
870.2500
Primary Skin Irritation
41123904
slight irritation
 III
870.2600
Dermal Sensitization
00139564
negative in Buehler
 Negative
870.6200a
Acute Neurotoxicity
none
none
 none

Table A.2.  Toxicity Profile of Abamectin Technical for Repeated Dosing and Genotoxicity Studies
                           Guideline No./ Study Type
                       MRID No. / Classification /Doses
                                    Results
870.3100
Subchronic feeding study-rats
00131081 (1982)
Unacceptable/Non-guideline
0, 0.10, 0.20, 0.40 mg/kg/day
NOAEL > 0.40 mg/kg/day
LOAEL = not established
870.3150
Subchronic toxicity
Dogs (18 week gavage study)
00131082 (1982)
Acceptable/Guideline
0, 0.25, 0.5, 2.0, 8.0 mg/kg/day
NOAEL = 0.25 mg/kg/day
LOAEL = 0.50 mg/kg/day based on body tremors, one death, liver pathology, decreased body weight. Mydriasis was seen during week one in one dog.
870.3150
12-Week dose range finding study-dogs (feeding)
 00164152 (1982)
0.25, 0.50, 1.0, and 4.0/2.0 mg/kg/day (during week 4, 4.0 mg/kg/day was reduced to 2.0 mg/kg/day  due to tremor, weakness, incoordination, and disorientation)
The report stated that mydriasis was seen in 1.0 and 4.0 mg/kg/day dogs during week 1.The effect was not seen at each examination day for any dog, but it was generally noted from 1 to 5 times a week. However, mydriasis was never noted at 0.5 and 0.25 mg/kg/day.
870.3200
21/28-Day dermal toxicity
Study not available.
Study not available.
870.4300a
Combined Chronic toxicity/carcinogenicity- rats
 40069601, 40375511, 40517801  (1985)
Acceptable/Guideline
0, 0.75, 1.5, 2.0 mg/kg/day

NOAEL = 1.5 mg/kg/day
LOAEL = 2.0 mg/kg/day based on tremors
No evidence of carcinogenicity
870.4100b
Chronic toxicity dogs
40375510 (1987)
Acceptable/Guideline
0, 0.25, 0.5, 1.0 mg/kg/day
NOAEL = 0.25 mg/kg/day
LOAEL = 0.5 mg/kg/day based on mydriasis during week one, death at 1.0 mg/kg/day
870.4300b
Combined Chronic toxicity/Carcinogenicity- mice
40069602, 40375512, 40517801 (1985)
Acceptable/Guideline
0, 2, 4, 8 mg/kg/day
NOAEL = 4.0 mg/kg/day
LOAEL = 8.0 mg/kg/day based on increased mortality in males, tremors, body weight decreases in females, dermatitis in males, extramedullary hematopoiesis in spleen of males
No evidence of carcinogenicity
870.3700a
Prenatal developmental
in rodents-rats
Accession: 00130819 (1982)
Acceptable/guideline
0, 0.4, 0.8, 1.6 mg/kg/day
Maternal NOAEL > 1.6 mg/kg/day
Maternal LOAEL = not established
Developmental NOAEL > 1.6 mg/kg/day
LOAEL = not established
870.3700a
Prenatal developmental in rodents-CD-1 mouse
44179901 (1999)
Acceptable/Non-Guideline
0, 0.75, 1.5, 3.0 mg/kg/day
Maternal NOAEL = 1.5 mg/kg/day
Maternal LOAEL = 3.0 mg/kg/day based on hind limb splay

Developmental NOAEL < 0.75 mg/kg/day
Developmental LOAEL = 0.75 mg/kg/day based on hind limb extension
870.3700b
Prenatal developmental
in nonrodents-rabbits

Accession: 00130819 (1982)
Acceptable./Guideline
0, 0.5, 1.0, 2.0 mg/kg/day
Maternal NOAEL = 1.0 mg/kg/day
Maternal LOAEL = 2.0 mg/kg/day based on decreased body weight, food consumption and water consumption
Developmental NOAEL = 1.0 mg/kg/day
LOAEL = 2.0 mg/kg/day based on cleft palate, clubbed foot, delayed ossification of sternebrae, metacarpals, phalanges
870.3800a
2-Generation Reproduction and fertility effects-rat
00164151 (1984)
Acceptable/Guideline
0, 0.05, 0.12, 0.40 mg/kg/day
Parental/Systemic NOAEL = 0.40 mg/kg/day
LOAEL =not established
Reproductive NOAEL = 0.40 mg/kg/day
LOAEL = not established
Offspring NOAEL = 0.12 mg/kg/day
LOAEL = 0.40 mg/kg/day based on increased retinal folds, increased dead pups at birth, decreased viability and lactation indices, decreased pup body weight
870.3800b
1-Generation Reproduction and fertility effects-rat
00096450
Unacceptable/Non-Guideline
0, 0.5, 1.0, 1.5/2.0 mg/kg/day
Parental/Systemic NOAEL = 1.0 mg/kg/day.
LOAEL=1.5/2.0 based on whole body tremors, ataxia, ptyalis, ocular/nasal discharges and mortality
Reproductive NOAEL = 3.0 mg/kg/day
Offspring NOAEL < 0.5 mg/kg/day
LOAEL = 0.5 mg/kg/day based on decreased pup survival and body weight between days 1-21 and delay in opening of eyes
870.3800c
1-Generation Reproduction and fertility effects- rat
00096451
Unacceptable/Non-guideline

0, 0.1, 0.2, 0.4 mg/kg/day
Parental/Systemic NOAEL = 0.4 mg/kg/day
LOAEL = not established
Reproductive NOAEL = 0.4 mg/kg/day
Offspring NOAEL =0.1 mg/kg/day
LOAEL = 0.2 mg/kg/day based on spastic movements and, delayed incisor eruption
870.3800c
1-Generation Reproduction and fertility effects- rat
40713404 (1988)
Acceptable/Non-guideline
0, 0.1, 0.2, 0.4 mg/kg/day
with delta-8,9 isomer
0, 0.06, 0.12, 0.40 mg/kg/day
Parental/Systemic NOAEL = 0.4 mg/kg/day
LOAEL = not established
Reproductive NOAEL = 0.4 mg/kg/day
Offspring NOAEL =0.4 mg/kg/day
LOAEL = not established
Gene Mutation
870.5100
Ames/Salmonella
E.coli/mammalian gene mutation assay
Accession: 246894, 265568, 265569 (1986)
Acceptable/Guideline
Three studies: (1) 0, 3, 10, 30, 100, 1000 ug/plate, (2) 0, 100, 300, 1000, 3000, 10,000 ug/plate both with and without S-9, (3) doses not specified.
negative both with and without S-9
870-6100
Acute neurotoxicity in rats (gavage)
46959202 (2006)
Acceptable/guideline
0.5, 1.5, and 6.0 mg/kg
NOAEL = 0.5 mg/kg/day
LOAEL = 1.5 mg/kg/day based on reduced splay reflex in males and females. At high dose, decreased motor activity, reduced splay reflex, & tip toe gait were seen. No death or histopathological changes in nervous system were found.
870-6200
Subchronic neurotoxicity in rats (gavage)
46959201 (2006)
Acceptable/guideline
0.4, 1.6, and 4.0 mg/kg/day
NOAEL = 1.6 mg/kg/day
LOAEL = 4.0 mg/kg/day based on upward curvature of the spine,
tip-toe gate, decreased fore- and hind-limb grip strength. Decreased body was also seen. This dose group was terminated prematurely  at week 7.
870-630
Developmental neurotoxicity study in rats

46727403, 46727402, 46727401 (2005)
Acceptable/nonguideline
0.12, 0.20, and 0.40 mg/kg/day. Pups were not directly dose.
Maternal NOAEL = 0.4 mg/kg/day (HDT)
Offspring NOAEL = 0.2 mg/kg/day.
Offspring LOAEL= 0.4 mg/kg/day based on decreased body weight in males and females..
870-6200
Developmental neurotoxicity study in rats

47116201 (2007)
Acceptable/nonguideline
0.12, 0.20, and 0.40 mg/kg/day.  Pups were not directly dosed.
Maternal NOAEL = 0.4 mg/kg/day (HDT)
Offspring NOAEL =0.12 mg/kg/day.
Offspring LOAEL = 0.2 mg/kg/day based on slight but statistically significant decrease in pup body weight.
Gene Mutation
870.5100
Ames/Salmonella
E.coli/mammalian gene mutation assay
40713402 (1988)
Acceptable/Guideline
doses not specified up to 3000 ug/plate both with and without S-9 using delta-8,9 isomer
negative both with and without S-9 up to 3000 ug/plate
Gene Mutation
870.5100
Ames/Salmonella
E.coli/mammalian gene mutation assay
40713405 (1988)
Acceptable/Guideline
doses up to 10,000 ug/plate both with and without S-9 using polar degradates
negative both with and without S-9
Gene Mutation
870.5300
CHO/HGPRT
Forward Mutation Assay
265570 (1986)
Acceptable/Guideline
both with and without S-9
Negative
Gene Mutation
870.5300
Mammalian cells in culture in V79 cells
MRID Unavailable
1983
Acceptable/Guideline

Not mutagenic for V79 cells in absence of S-9, but in the presence of S-9 appeared to have a mutagenic potential, provided the test cells had an appropriate level of sensitivity
Cytogenetics
870.5395
in vivo micronucleus assay -male mice
MRID Unavailable
Acceptable/non-Guideline
0, 1.2, 12.0 mg/kg  i.p.
No chromosomal aberrations in male mice, but females not tested
Other Effects
870.5550
MRID Unavailable
(1983)
0.3 and 0.6 mM
single strand DNA breaks at 0.3 and 0.6 mM in rat hepatocytes in vitro, but negative when hepatocytes from rat at LD50 dose level was used
Metabolism
Accession: 252114
Unacceptable/Non-Guideline
69-82% of label is excreted in feces by day 7; T(1/2)=1.2 days.  The reliability of these data is questionable.
Metabolism
No MRID
(1985)
Nonguideline
Avermectin B1a did not bioaccumulate in rat tissues.  Half-life slightly longer in females than in males for several tissues.
Metabolism
No MRID
(1985)
Nonguideline
The metabolism of avermectin B1 in rats results in the formation of 24-OH-Me-B1a and accounts for most of the radiolabeled residues.  Avermectin B1a does not bioaccumulate.
870.7600
Dermal penetration
 Accession: 265590 (1986)
Acceptable/
Nonguideline in Monkeys
Dermal penetration is 1%.

      Table A.3.  Toxicity Profile of Abamectin Technical - for CF1 Mice
                           Guideline No./ Study Type
                       MRID No. / Classification /Doses
                                    Results
870.3700a
Prenatal developmental in rodents- CF1 mouse
44160501 (1996)
Acceptable/Non-Guideline
0, 1.5 mg/kg/day on gestation days (GD) 6-15 to females which were heterozygous (+/-) and homozygous (-/-, +/+) for p-glycoprotein and then mated to heterozygous and homozygous males
Maternal NOAEL = 1.5 mg/kg/day
Maternal LOAEL = not established
97% of (-,-) fetuses, 40% of (+,-) fetuses, and 0% of (+,+) fetuses had cleft palate.  It was determined that the observed increase in cleft palate in CF-1 mice following treatment appears to be a consequence of fetal P-glycoprotein genotype.
870.3700a
Prenatal developmental
in rodents-CF1 mouse
Accession: 265564 (1986)
Acceptable/Guideline
0, 1.5, 3.0, 6.25, 12.5, 25, 50 mg/kg/day with delta-8,9 isomer
Maternal NOAEL < 1.5 mg/kg/day
Maternal LOAEL = 1.5 mg/kg/day (mortality)
Developmental NOAEL < 1.5  mg/kg/day
LOAEL = 1.5 mg/kg/day based on increased cleft palate
870.3700a
Prenatal developmental in rodents-CF1 mouse
Accession: 265564 (1986)
Acceptable/Guideline
0, 0.03, 0.1, 0.5  mg/kg/day with delta-8,9 isomer
Maternal NOAEL = 0.1 mg/kg/day
Maternal LOAEL = 0.5 mg/kg/day (mortality)
Developmental NOAEL = 0.03  mg/kg/day
LOAEL = 0.1 mg/kg/day based on increased cleft palate
870.3700a
Prenatal developmental in rodents-CF1 mouse
Accession: 265564 (1985)
Acceptable/Guideline
0, 0.05, 0.1, 0.5, 1.0 mg/kg/day with deta-8,9 isomer
Maternal NOAEL = 0.1 mg/kg/day
Maternal LOAEL = 0.5 mg/kg/day (mortality)
Developmental NOAEL = 0.05  mg/kg/day
LOAEL = 0.1 mg/kg/day based on increased cleft palate
870.3700a
Prenatal developmental in rodents-CF1 mouse
Accession: 40912701 (1988)
Acceptable/Guideline
0, 0.25, 0.50, 1.0 mg/kg/day with citrus derived polar degradates
Maternal NOAEL > 1.0 mg/kg/day
Maternal LOAEL = not established
Developmental NOAEL > 1.0  mg/kg/day
LOAEL =not established
870.3700a
Prenatal developmental in rodents-CF1 mouse
Accession: 073759, 073761 (1984)
Acceptable/Non-Guideline
0, 0.1, 0.3, 0.6 mg/kg/day
Maternal NOAEL = 0.1 mg/kg/day
Maternal LOAEL = 0.3 mg/kg/day (mortality, tremors)

870.3700a
Prenatal developmental in rodents-CF1 mouse
00096446 (1986)
Acceptable/Guideline
0, 0.1, 0.2, 0.4, 0.8  mg/kg/day
Maternal NOAEL < 0.1 mg/kg/day
Maternal LOAEL = 0.1 mg/kg/day (mortality)
Developmental NOAEL = 0.2  mg/kg/day
LOAEL = 0.4 mg/kg/day based on increased cleft palate
870.3700a
Prenatal developmental in rodents-CF1 mouse
Accession: 265564 (1985)
Acceptable/Guideline
0, 0.01, 0.03, 0.06 mg/kg/day with delta-8,9 isomer
Maternal NOAEL > 0.06 mg/kg/day
Maternal LOAEL = not established
Developmental NOAEL > 0.06  mg/kg/day
LOAEL = not established
870.3700a
Prenatal developmental in rodents-CF1 mouse
Accession: 40713406 (1986)
Acceptable/Guideline
0, 0.25, 0.50, 1.0 mg/kg/day with polar degradates of abamectin
Maternal NOAEL > 1.0 mg/kg/day
Maternal LOAEL = not established
Developmental NOAEL > 1.0  mg/kg/day
LOAEL = not established

Appendix B:	Toxicology Literature References

Dawson GR, Wafford KA, Smith A, Marshall GR, Bayley PJ, Schaeffer JM, Meinke PT,
	McKernan RM. (2000) Anticonvulsant and adverse effects of avermectin analogs in mice
	are mediated through the gama-aminobutyric acid (A) receptor. J. Pharmacol. Exp. Ther.
      295: 1051-1060.

Huang J, Casida JE. (1997) Avermectin B1a	binds to high- and low-affinity sites with dual
	effects on the gama-aminobutyric acid-gated chloride channel of cultured cerebellar
	granule neurons. J. Pharmacol. Exp. Ther. 281: 261-266.

Kerb R (2006) Implication of genetic polymorphism in drug transporters for pharmacotherapy.
	Cancer Lett. 234: 4-33.

Kerr DI and Ong J. (1986) Gama-aminobutyric acid-dependent motility induced by avermectin B1a in the isolated intestine of the guinea pigs. Neurosci. Lett. 65: 7-10.

Lankas GR, Cartwright ME, and Umbenhauer D (1997) P-Glycoprotein deficiency in a
	subpopulation of CF-1 mice enhances avermectin-induced neurotoxicity. Toxicol. and Appl. Pharmacol. 143: 357-365.

Marzolini C, Paus E, Buclin T, and Kim RB (2004) Polymorphism I human MDR1 (P-
	glycoprotein): Recent advances and clinical relevance. Clin. Pharmacol. and Ther.
	75: 13-33.

Meister B. (2007) Neurotransmitters in key neurons of the hypothalamus that regulate feeding
      behavior and body weight. Physiol. Behav. 92: 263-271.

Nguyen L, Rigo JM, Rocher V, Belachew S, Malgrange B, Rogister B, Leprince P, Moonen G.
	(2001) Neurotransmitters as early signals for central nervous system development. Cell
	Tissue Res. 305: 187-202.

Pong SS, DeHaven R, Wang CC. (1982) A comparative study of avermectin B1a and other
	modulators of the gama-aminobutyric receptor- chloride ion channel complex. J.
	Neurosci. 2: 966-971.

Represa A, Ben-Ari Y. (2005) Trophic actions of GABA on neuronal development. Trends
	Neurosci. 28: 278-283.

Habashi, SL (2006) Dubin-Johnson Syndrome. http://www.emedicine.com/med/topic 588.htm

Wang CC, Pong SS. (1982) Actions of avermectin B1a on GABA nerves. Prog. Clin. Biol. Res.
		97: 373-395.

Appendix C:	Physical/Chemical Properties

Table C.  Physiochemical Properties
Parameter
                                     Value
                                 Reference[1]
Molecular Weight
873.11

Melting point/range
155-157°C
Accession No. 260785
pH
Not available

Density
1.16 g/cm[3] at 21°C
Accession No. 260785
Water solubility (20°C)
< 0.01 mg/mL in distilled water
< 0.001 mg/mL in tap water
< 0.001 mg/mL in buffer system pH 6, 7.4 & 9.0
< 0.001 mg/mL in 0.9% NaCl
Accession No. 260785
Solvent solubility (20°C to 25°C)
> 3 mg/mL in ethanol; >2 mg/mL in isopropyl myristate, chloroform, dimethylacetamide, dimethylformamide, glycerol formal & polyethylene glycol 400.
Accession No. 260785
Vapor pressure (25°C)
1.5 x 10[-9] hPa
Accession No. 260785
Dissociation constant, pKa
Not available

Octanol/water partition coefficient, Log(KOW)
9.9 x 10[-3]
Accession No. 260785
UV/visible absorption spectrum
Not available

1   Product Chemistry data were reviewed by Leung Cheng (Accession No. 260785, RCB No. 388, 5/1/1986).

Appendix D:	Review of Human Research

This risk assessment relies in part on data from Pesticide Handlers Exposure Database (PHED) and the Agricultural Reentry Task Force (ARTF) database in which adult human subjects were intentionally exposed to a pesticide or other chemical.  These studies have been reviewed for ethical conduct and have been determined to be ethical.

The two studies used to estimate residential post-application exposure from abamectin crack and crevice products [ref: "Evaluation of Avert Prescription Treatment 310 Residual Study in Air, Food and on Surfaces," dated November 8, 1990 (MRID No. 44665901), and "Evaluation of Indoor Exposure to a Crack and Crevice Application of Whitmire Avert Crack and Crevice Prescription Treatment 310 and Prescription TC 93A Bait," dated October 27, 1995 (MRID No. 44147801)] measured only ambient concentrations of abamectin in treated areas and did not involve collection of data for estimation of direct human exposure from the application activity.  Therefore, the requirements for ethical review or for review by the Human Studies Review Board are not applicable to these studies.

Appendix E:	International Residue Limits

                    Abamectin (PC Code 122804; 03/31/2011)
Summary of US and International Tolerances and Maximum Residue Limits
Residue Definition:
US
Canada
Mexico
Codex
40 CFR 180.449:
Plant/Livestock:  sum of avermectin B1 (a mixture of avermectins containing greater than or equal to 80% avermectin B1a (5-O-demethyl avermectin A1) and less than or equal to 20% avermectin B1b (5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl) avermectin A1)) and its delta-8,9-isomer
avermectin B1 (a mixture of avermectins containing greater than or equal to 80% avermectin B1a (5-O-demethyl avermectin A1a) and less than or equal to 20%
avermectin B1b (5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl) avermectin A1a) and its delta-8,9-isomer)

Plants: sum of avermectin B1a, avermectin B1b, 8,9-Z-avermectin B1a and 8,9-Z-avermectin B1b. Animal commodities: sum of avermectin
B1a and 8,9-Z-avermectin B1a.

Commodity
Tolerance (ppm) /Maximum Residue Limit (mg/kg)

                                      US
Canada
Mexico
Codex
Onion, bulb, subgroup 3-07A
                                     0.01

Chive, fresh leaves
                                     0.01

Chive, dried leaves
                                     0.02

Bean, dry, seed, except cowpea
                                     0.01

Completed:  M. Negussie; 03/31/2011


[Federal Register Volume 80, Number 80 (Monday, April 27, 2015)]
[Notices]
[Pages 23271-23272]
[FR Doc No: 2015-09756]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9926-83-OA]

Notification of a Public Teleconference of the Chartered Science
Advisory Board

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) Science Advisory
Board (SAB) Staff Office announces a public teleconference of the
Chartered SAB to discuss information provided in the agency's Fall 2014
regulatory agenda and to review the draft SAB report on the EPA's
approach to develop preliminary bi-national phosphorous

objectives and loading targets for Lake Erie.

DATES: The public teleconference for the Chartered SAB will be held on
Wednesday, May 27, 2015, from 1:00 p.m. to 3:30 p.m. (Eastern Standard
Time).
    Location: The public teleconference will be conducted by telephone
only.

FOR FURTHER INFORMATION CONTACT: Any member of the public wishing to
obtain information concerning the public teleconferences may contact
Mr. Thomas Carpenter, Designated Federal Officer (DFO), EPA Science
Advisory Board Staff Office (1400R), U.S. Environmental Protection
Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; by
telephone/voice mail at<PHONE_NUMBER> or at<EMAIL_ADDRESS>
General information about the SAB as well as any updates concerning the
teleconferences announced in this notice may be found on the EPA Web
site at http://www.epa.gov/sab.

SUPPLEMENTARY INFORMATION: The SAB was established pursuant to the
Environmental Research, Development, and Demonstration Authorization
Act (ERDDAA), codified at 42 U.S.C. 4365, to provide independent
scientific and technical advice to the Administrator on the technical
basis for Agency positions and regulations. The SAB is a federal
advisory committee chartered under the Federal Advisory Committee Act
(FACA), 5 U.S.C., App. 2. Pursuant to FACA and EPA policy, notice is
hereby given that the Chartered SAB will hold a public teleconference
for two purposes.
    The first purpose is to discuss recommendations regarding the
information provided in the agency's Fall 2014 regulatory agenda,
specifically planned actions and their supporting science. Information
about this advisory activity can be found on the Web at http://yosemite.epa.gov/sab/sabproduct.nsf/fedrgstr_activites/SAB%20Fall%202014%20Reg%20Agenda?OpenDocument.
    The second purpose of this public teleconference is to review a
draft SAB consultation report on the scientific and technical merit of
the EPA's draft approach to develop preliminary bi-national phosphorous
objectives and loading targets for Lake Erie. Quality review is a key
function of the chartered SAB. Draft reports prepared by SAB
committees, panels, or work groups must be reviewed and approved by the
chartered SAB before transmittal to the EPA Administrator. Consistent
with FACA, the chartered SAB makes a determination in a public meeting
about each draft report and determines whether the report is ready to
be transmitted to the EPA Administrator.
    The SAB review will focus on a draft report on the EPA's plan to
use an ensemble modeling approach to develop preliminary binational
phosphorous objectives, loading targets and allocations for nearshore
and offshore waters. Information about this advisory activity can be
found on the Web at http://yosemite.epa.gov/sab/sabproduct.nsf/fedrgstr_activites/GLWQA?OpenDocument.
    Availability of Meeting Materials: The agenda and materials in
support of these teleconferences will be available on the EPA Web site
at http://www.epa.gov/sab in advance of the teleconferences.
    Procedures for Providing Public Input: Public comment for
consideration by EPA's federal advisory committees and panels has a
different purpose from public comment provided to EPA program offices.
Therefore, the process for submitting comments to a federal advisory
committee is different from the process used to submit comments to an
EPA program office.
    Federal advisory committees and panels, including scientific
advisory committees, provide independent advice to EPA. Members of the
public can submit comments for a federal advisory committee to consider
as it develops advice for EPA. Input from the public to the SAB will
have the most impact if it provides specific scientific or technical
information or analysis for SAB panels to consider or if it relates to
the clarity or accuracy of the technical information. Members of the
public wishing to provide comment should contact the Designated Federal
Officer as noted above. Oral Statements: In general, individuals or
groups requesting an oral presentation at a teleconference will be
limited to three minutes. Each person making an oral statement should
consider providing written comments as well as their oral statement so
that the points presented orally can be expanded upon in writing.
Interested parties should contact Mr. Carpenter, DFO, in writing
(preferably via email) at the contact information noted above one week
before the teleconference to be placed on the list of public speakers.
Written Statements: Written statements should be supplied to the DFO,
preferably via email, at the contact information noted above one week
before each of the teleconferences so that the information may be made
available to the Board members for their consideration. It is the SAB
Staff Office general policy to post written comments on the Web page
for the advisory meeting or teleconference. Submitters are requested to
provide an unsigned version of each document because the SAB Staff
Office does not publish documents with signatures on its Web sites.
Members of the public should be aware that their personal contact
information, if included in any written comments, may be posted to the
SAB Web site. Copyrighted material will not be posted without explicit
permission of the copyright holder.
    Accessibility: For information on access or services for
individuals with disabilities, please contact Mr. Thomas Carpenter at
(202) 564-4885 or<EMAIL_ADDRESS>To request accommodation of
a disability, please contact Mr. Carpenter preferably at least ten days
prior to the teleconference to give EPA as much time as possible to
process your request.

    Dated: April 20, 2015.
Thomas H. Brennan,
Deputy Director, EPA Science Advisory Staff Office.
[FR Doc. 2015-09756 Filed 4-24-15; 8:45 am]
 BILLING CODE 6560-50-P