[Federal Register Volume 82, Number 26 (Thursday, February 9, 2017)]
[Notices]
[Page 9999]
[FR Doc No: 2017-02652]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Public Comment Session Schedule Change for the Draft
Environmental Impact Statement for the Proposed Atlantic Coast
Pipeline, Supply Header Project, and Capacity Lease Proposal

------------------------------------------------------------------------
                                                   Docket Nos.
------------------------------------------------------------------------
Atlantic Coast Pipeline, LLC...........  CP15-554-000,
                                         CP15-554-001
Dominion Transmission, Inc.............  CP15-555-000
Piedmont Natural Gas Company, Inc......  CP15-556-000
------------------------------------------------------------------------

    On December 30, 2016, the Commission issued a Notice of
Availability of the draft environmental impact statement in the above-
captioned proceeding. Due to a scheduling conflict with the contracted
venue in Nelson County, the start time for the public comment session
scheduled on February 22 at Nelson County High School has changed. This
errata notice announces the Wednesday, February 22, 2017 public comment
session will begin at 6:30 p.m. The session ending time remains 9:00
p.m. Additional court reporters will be available at the Nelson County
High School public comment session to account for the reduced session
length.

    Dated: February 2, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-02652 Filed 2-8-17; 8:45 am]
 BILLING CODE 6717-01-P


Baseline: 2.9

                         Single layer w/gloves:  0.023

                                  Inhalation
                              Baseline:  0.0012
                                     0.078
                                      80
                                    Dermal
                              Baseline[6]: 0.026

                      Single layer w/gloves[8]:  0.00021
                         Baseline Dermal + Inhalation
                                     0.026

                      Single layer w/gloves + Inhalation
                                    0.00032
                                    Dermal
                                 Baseline[6]:
                                      170
                       Single layer w/gloves[8]: 21,000
                         Baseline Dermal + Inhalation
                                      170

                  Single layer w/gloves + Baseline Inhalation
                                    14,000

                                  Inhalation
                             Baseline[7]:  0.00011

                        Inhalation Baseline[7]:  41,000

                    (2) Mixer/Loader  -  Aerial Application
                                    Dermal
                                 Baseline: 2.9

                         Single layer w/gloves:  0.023

                                  Inhalation
                              Baseline:  0.0012
                                     0.078
                                      350
                                    Dermal
                                Baseline:  0.11

                            Single layer w/gloves:
                                    0.00090
                          Baseline Dermal + Inhalation
                                     0.11

                      Single layer w/gloves + Inhalation
                                    0.0014
                                    Dermal
                                 Baseline:  39

                            Single layer w/gloves:
                                    13,000
                         Baseline Dermal + Inhalation
                                      39

                  Single layer w/gloves + Baseline Inhalation
                                     3,200

                                  Inhalation
                               Baseline: 0.00047

                                  Inhalation
                                Baseline: 9,400

                   (3) Applicator  -  Groundboom Application
                                    Dermal
                               Baseline:  0.014

                                  Inhalation
                              Baseline:  0.00074
                                     0.078
                                      80
                                    Dermal
                              Baseline:  0.00012
                         Baseline Dermal + Inhalation
                                    0.0002
                                    Dermal
                               Baseline: 35,000
                         Baseline Dermal + Inhalation
                                    23,000

                                  Inhalation
                              Baseline:  0.000066

                                  Inhalation
                               Baseline: 66,000

                     (4) Applicator  -  Aerial Application
                                    Dermal
                         Engineering Control:  0.0050

                                  Inhalation
                        Engineering Control:  0.000068
                                     0.078
                                      350
                                    Dermal
                             Engineering control:
                                    0.0002
                         Combined Engineering Control
                                    0.00023
                                    Dermal
                             Engineering control:
                                    22,000
                         Combined Engineering Control
                                    20,000

                                  Inhalation
                        Engineering control:  0.000027

                                  Inhalation
                         Engineering control:  170,000

                      (5) Flagger  -  Aerial Application
                                    Dermal
                                Baseline: 0.011

                                  Inhalation
                              Baseline: 0.00035
                                     0.078
                                      350
                                    Dermal
                               Baseline: 0.00043

                         Baseline Dermal + Inhalation
                                    0.0006
                                    Dermal
                               Baseline: 10,000
                         Baseline Dermal + Inhalation
                                     7,700

                                  Inhalation
                              Baseline:  0.00014

                                  Inhalation
                               Baseline:  32,000

1 Application rate is the maximum recommended rate provided on the novaluron product label.
2 Area treated per day values are HED estimates based on ExpoSAC Policy #9 "Standard Values for Daily Acres Treated in Agriculture," industry sources, and HED estimates.
3 Dose (mg/kg/day) = Unit exposure (mg/lb ai) x App Rate (lb ai/acre) x Area Treated (acres/day) x % Absorption (10% dermal and 100% inhalation assumed) / Body weight.  The body weight is 70 kg for the inhalation and dermal dose.
4 Total Dose = Dermal + Inhalation Dose.
5 Short-/Intermediate-term MOE = Intermediate-term dermal or Short/Intermediate-term inhalation NOAEL (4.38 mg/kg/day) / Dermal or Inhalation dose (mg/kg/day)
6 Total MOE = NOAEL (4.38 mg/kg/day)/Total Dose.
7 Baseline Dermal:  long-sleeved shirt, long pants, no gloves.
8 Baseline Inhalation:  no respirator.
9 Single layer with gloves:  single layer baseline attire plus chemical-resistant gloves.

8.1.2	Crack and Crevice/Spot Use

There is also a potential for occupational handler exposure from the proposed use for indoor and outdoor control of roaches and crickets.  Occupational handler's exposure and risk were estimated for the following scenarios:

   * Mixing/loading/applying emulsifiable concentrate formulations with low-pressure handwand (PHED), and
   * Applying ready to use formulations via trigger-pump sprayer (ORETF).

Chemical-specific data were not submitted to the Agency in support of this Section 3 application.  It is HED policy to use data from PHED Version 1.1 and/or the ORETF to assess handler exposures when chemical-specific data are not submitted.

As with the residential assessment for purposes of assessing a crack and crevice exposure scenario for commercial applicators, HED used the mixing/loading/applying wettable powders with a low-pressure handwand scenario as a surrogate to assess handler exposure to the emulsifiable concentrate formulation.  Usually, HED would use surrogate data for liquid formulation as surrogate for EC formulation.  However, The unit exposure values provided for the wettable powder formulation are based on actual exposures measured during crack and crevice applications; whereas, the unit exposure values for the liquid formulation are based on applications to chicken houses and greenhouses.  Therefore, although the RIMON[(R)] SUPRA 10EC Insecticide is formulated as an EC, HED believes that the use of unit exposure values resulting from crack and crevice applications provides a more accurate representation of handler exposure.

There is no short-term dermal POD; therefore, only intermediate-term dermal exposure has been assessed and should be considered protective of short-term dermal exposure.  Short- and intermediate-term inhalation exposures have been assessed.  In addition, the short- and intermediate-term inhalation toxicological points of departure are the same; therefore, the estimates of risk for short-term duration inhalation exposures are protective of those for intermediate-term inhalation duration exposures.  The average adult body weight of 70 kg was used for estimating inhalation and dermal dose.  A 10% dermal-absorption factor was used to estimate dermal exposure for all durations.  Long-term exposures are not expected; therefore, a long-term assessment was not conducted.  Exposures, doses and MOEs were calculated using the equations presented in the residential section (Section 5.1).

Table 8.1.2 presents a summary of the short- and intermediate-term occupational handler exposures and risks.  The results of the occupational handler exposure and risk assessment indicate that MOEs do not exceed HEDs LOC (i.e., MOEs >=100) with either baseline attire (i.e., single layer of clothing, no respirator) or with the addition of gloves.  There is no unit exposure data for the mixing/loading/applying wettable powders scenario with baseline attire and no gloves; therefore, this scenario was only assessed assuming handlers were wearing gloves.   The proposed label for novaluron does not currently recommend any personal protective equipment for handlers.  HED recommends RD require the addition of chemical-resistant gloves to the label.

Table 8.1.2.  Short- and Intermediate-Term Occupational Handler Exposure and Risk for Novaluron.
                              Application Rate[a]
                           Amount applied Daily[b]
                         Unit Exposures (mg/lb ai)[c]
                             Dose (mg/kg/day)[f,g]
                    Short- and Intermediate-term MOEs[h,i]

                              Baseline Dermal[d]
                            Baseline Inhalation[d]
                               PPE-G Dermal[e]
                                Baseline Dermal
                              Baseline  Inhalation
                                 PPE-G Dermal
                                Baseline Dermal
                             Baseline Inhalation
                                 PPE-G Dermal
                                   Total MOE

                     Baseline Dermal + Baseline Inhalation
                      PPE-G Dermal + Baseline Inhalation
   Mixing/Loading/Applying Wettable Powders with Low-Pressure Handwand (PHED)
                                0.02 lb ai/gal
                                  40 gallons
                                    No Data
                                      1.1
                                      8.6
                                      N/A
                                     0.013
                                    0.0098
                                      N/A
                                      350
                                      450
                                      N/A
                                      200
      Applying Ready-to-Use Formulations via Trigger-Pump Sprayer (ORETF)
                                0.02 lb ai/gal
                                   2 gallons
                                      42
                                     0.019
                                      1.8
                                    0.0024
                                   0.000011
                                    0.0001
                                     1,800
                                    400,000
                                    43,000
                                     1,800
                                    39,000
	a.	Application rate based on proposed use on label for novaluron product RIMON[(R)] EC Insecticide (Reg. No. 66222-ERT).  Maximum rate = 3.1 oz/gal (0.02 lb ai/gal).
	b. 	ExpoSAC Policy # 9.1.
	c. 	Unit Exposures for low-pressure handwand scenario based on PHED Version 1.1.  For purposes of assessing a crack and crevice exposure scenario for commercial applicators,
              HED used the mixing/loading/applying wettable powders with a low-pressure handwand scenario as a surrogate to assess handler exposure to the liquid formulation.  See text above table for full explanation.  Unit exposures for trigger-pump sprayer scenario based on ORETF (OMA006; MRID 444598-01).
	d. 	Baseline Dermal:  Long-sleeve shirt, long pants, and no gloves (none is specified on the label); Baseline Inhalation: no respirator.  Unit exposure data for the 				mixing/loading/applying wettable powders with low pressure handwand scenario at baseline with no gloves is not available; therefore, this scenario was only assessed with the use 			of gloves.

	e. 	PPE-G Dermal: Baseline plus chemical-resistant gloves.
	f. 	Dermal Dose (mg/kg/day) = daily unit exposure (mg/lb ai) * application rate (lb ai/gallon) * amount handled (gallons) * dermal absorption factor (10%) / body weight (70 kg).
	g. 	Inhalation Dose (mg/kg/day) = daily unit exposure (mg/lb ai) * application rate (lb ai/gallon) * amount handled (gallons) * inhalation absorption (100%) / body weight (70 kg).
	h. 	MOE = NOAEL (short- and intermediate-term = 4.38 mg/kg/day) / daily dose (mg/kg/day).  LOC = 100.
	i. 	Total MOEs = NOAEL (mg/kg/day) / (Dermal dose + Inhalation dose).

8.2	Occupational Post-Application Worker Exposure and Risk

8.2.1 	Occupational Post-Application Worker Exposure and Risk for Sweet Corn

The proposed use is for a post emergent application; therefore, a dermal post-application exposure assessment was conducted.  The registrant submitted two studies:

      Willard, T. (2002) Foliar Dislodgeable Residue Dissipation of Novaluron in Cotton: Final Study Report: Lab Project Number: AA010705: R-13884:989W. Unpublished study prepared by American Agricultural Services, Inc. 214 p. {OPPTS 875.2100}

Willard, T. (2002) Foliar Dislodgeable Residue Dissipation of Novaluron in Apple: Lab Project Number: AA01076: R-13883: AA010706.CA. Unpublished study prepared by American Agricultural Services, Inc. 204 p. {OPPTS 875.2100}

HED decided not to use the apple study due to some study limitations and differences in the use pattern (different application rate and application equipment used) and differences in plant/leaf morphology (apple versus corn).

HED did use chemical-specific data provided in the cotton study.  This study was designed to determine the dissipation of dislodgeable foliar residues (DFR) of novaluron applied to cotton foliage at two test sites located in Porterville, California and Washington, Louisiana.  Three applications of Rimon(R) 10EC, an EC formulation containing novaluron (0.83 lb ai/gal) were made to cotton foliage at a target rate of 0.091 lb ai/A/application.  The re-treatment interval was 7 days.  Applications were made as a foliar broadcast spray at a spray volume of approximately 21 to 28 gallons of spray solution per acre (GPA) using groundboom equipment.  There were no surfactants/adjuvants included in the spray mixtures.

At the California site, the highest average DFR value occurred immediately after the third application (0.673 μg/cm2).  The residues declined to an average of 0.361 μg/cm2 by Day 21 after the third application, and then increased to an average of 0.483 μg/cm2 by Day 35 after the third application.  At the Louisiana site, the highest average DFR value occurred immediately after the third application (0.142 μg/cm2).  The residues then declined to below the LOQ by Day 28 after the third application.  The registrant generated dissipation curves using a linear first order kinetic model of the natural log transformed data.  The analysis was conducted using the individual DFR values collected immediately after the third application through the last day of sampling.  The registrant's calculated half-lives for novaluron in cotton foliage were 59 days for the California site and 8 days for the Louisiana site.  This difference in dissipation is due to the difference in climate, with Louisiana being a more humid climate (more rainfall), and California being a more arid climate (less rainfall).  In California and other arid areas which receive less than 20 inches of precipitation per year, the residues are not expected to dissipate, and therefore only 1 application of novaluron should be required.  The registrant should submit a revised label which specifies that the retreatment of sweet corn with novaluron is prohibited (i.e., only 1 application is allowed at a rate of 0.078 lb ai/A) in California and other arid areas which receive less than 20 inches of precipitation per year.  See Memo, L. Venkateshwara, 29-MAR-2011; D387931 for the analysis of the data from the CA site, and see memo, L. Venkateshwara, 29-MAR-2011; D387932 for the analysis of the data from the LA site.

 Post-application exposures have been assessed using the submitted dislodgeable foliar residue data as well as dermal transfer coefficients from HED's ExpoSAC Policy Number 3.1 "Agricultural Transfer Coefficients" (August, 2000).  Table 8.2.1 summarizes the scenarios assessed.  In addition, the following assumptions were used in the calculations:

      * Application Rate	           		 = 	0.078 lb ai/A
      * Exposure Duration		 =	8 hours per day
      * Body Weight			 =	70 kg for adult male
      * Dermal Absorption		 = 	10%
      * Dislodgeable foliar residue (DFR) =	chemical-specific data from MRID # 456384-16.

 Table 8.2.1.  Anticipated Post-application Activities and Dermal Transfer Coefficients.
                                 Proposed Crop
                           Policy Crop Group Category
                        Transfer Coefficients (cm[2]/hr)
                                   Activities
                                   Sweet Corn
                              Field/row crop tall
                                      100
                                  Hand weeding

                                      1000
                            Irrigation and scouting

                                     17000
                          Detasseling and hand harvest

Equations/Calculations:

Daily dermal exposures were calculated on each post-application day after application using the following equation:

Daily Dermal Doset  =  [DFRt (ug/cm[2]) x 0.001 mg/ug x TC (cm[2]/hr) x DA x ET (hrs)]  /  BW (kg)

Where:
		DFRt 	=	dislodgeable foliage residue on day "t" (ug/cm[2]);
		TC	=	transfer coefficient (cm[2]/hr);
		DA	=	dermal absorption factor (100%);
		ET	=	exposure time (8 hr/day); and
		BW	=	body weight (70 kg).

Once daily exposures are calculated, the calculation of daily absorbed dose and the resulting MOEs use the same algorithms that are described above for the handler exposures.  These calculations are completed for each day or appropriate block of time after application.

Table 8.2.2 presents a summary of occupational post-application risks associated with use of novaluron at the Louisiana site and Table 8.2.3 presents the summary of the occupational post-application risks associated with use of novaluron at the California site.

Table 8.2.2.  Post-application Risks for Novaluron Using Data from the Louisiana Site.
                                     Crop
                               Application  Rate
                                   (lb ai/A)
                             Transfer Coefficient
                                  (cm[2]/hr)
                                    DFR[1]
                                   (ug/cm[2])
                             Days After Treatment
                                 Daily Dose[2]
                                  (mg/kg/day)
                                    MOE[3]
                                   Sweet Corn
                                     0.078
                                      100
                                     0.118
                               12 hours (0 days)
                                   0.000137
                                    32,000

                                     1,000

                                    0.00137
                                     3,200

                                     17000

                                     0.023
                                      190
  The information in the table is based on proprietary and non-proprietary data.
  [1] DFR calculated from MRID #456384-16 Louisiana site.
  [2] Daily Dose = [DFR (ug/cm[2]) x TC (cm[2]/hr) x 0.001 mg/ug x Dermal Absorption (10%) x 8 hrs/day] / Body Weight (70 kg).
  [3] NOAEL/Daily Dose (Intermediate-term NOAEL = 4.38 mg/kg/day).

Table 8.2.3.  Post-application Risks for Novaluron Using Data from the California Site.
                                     Crop
                               Application  Rate
                                   (lb ai/A)
                             Transfer Coefficient
                                  (cm[2]/hr)
                                    DFR[1]
                                   (ug/cm[2])
                             Days After Treatment
                                 Daily Dose[2]
                                  (mg/kg/day)
                                    MOE[3]
                                   Sweet Corn
                                     0.078
                                      100
                                     0.58
                               12 hours (0 days)
                                    0.00066
                                     6,600

                                     1,000

                                    0.0066
                                      660

                                     17000

                                     0.113
                                      39
  The information in the table is based on proprietary and non-proprietary data.
  [1] DFR calculated from MRID #456384-16 California site.
  [2] Daily Dose = [DFR (ug/cm[2]) x TC (cm[2]/hr) x 0.001 mg/ug x Dermal Absorption (10%) x 8 hrs/day] / Body Weight (70 kg).
  [3] NOAEL/Daily Dose (Intermediate-term NOAEL = 4.38 mg/kg/day).

Based on the differences in DFR data from the Louisiana site (a more humid climate) and the California site (a dry climate), HED is recommending two different retreatment intervals, one for humid climates and one for arid climates.  For humid climates a retreatment interval of 7 days is acceptable; however, for arid climates where DFR data show that there is no dissipation, only 1 application should be allowed at a rate of 0.078 lb ai/A.  Table 8.2.4 shows the calculations for the MOE at the California site after one application.  The MOE at the highest TC is 175, which is greater than 100.

Table 8.2.4.  Post-application Risks for Novaluron at California Site after 1 Application.
                                     Crop
                               Application  Rate
                                   (lb ai/A)
                             Transfer Coefficient
                                  (cm[2]/hr)
                                DFR (ug/cm[2])
                             Days After Treatment
                                 Daily Dose[1]
                                  (mg/kg/day)
                                    MOE[2]
                                   Sweet Corn
                                     0.078
                                      100
                                     0.13
                               12 hours (0 days)
                                    0.00015
                                    29,000

                                     1,000

                                    0.0015
                                     2,900

                                     17000

                                     0.025
                                      175
The information in the table is based on proprietary and non-proprietary data.
[1]  Daily Dose = [DFR (ug/cm[2]) x TC (cm[2]/hr) x 0.001 mg/ug x Dermal Absorption (10%) x 8 hrs/day] / Body Weight (70 kg)
[2]  NOAEL/Daily Dose (Intermediate-term NOAEL = 4.38 mg/kg/day)

Inhalation

Based on the Agency's current practices, a quantitative occupational post-application inhalation exposure assessment was not performed for novaluron 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 FIFRA 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 as well as available post-application inhalation exposure data generated by the Agricultural Reentry Task Force and 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 novaluron.

Restricted Reentry Interval

Novaluron is classified as acute Toxicity Category III for acute dermal toxicity.  It is classified as Toxicity Category IV for primary eye irritation and primary skin irritation.  Therefore, the interim WPS REI of 12 hours is adequate to protect agricultural workers from post-application exposures to novaluron.

8.2.2 	Crack and Crevice/Spot Use

Based on the proposed use sites associated with the indoor crack and crevice/spot use, HED believes the presence of commercial workers in treated areas is minimal after application.  Therefore, an occupational quantitative post-application assessment for this product was not conducted.

9.0	DATA NEEDS AND LABEL RECOMMENDATIONS

9.1	Toxicology
   * A 90-day inhalation toxicity study is requested for further characterization of inhalation risk.  Due to the potential for repeated inhalation exposure anticipated from the proposed residential use pattern, there is concern for toxicity by the inhalation route.  An inhalation study would provide a dose and endpoint via the route of exposure of concern (i.e. route specific study) and thus would avoid using an oral study and route-to-route extrapolation.  An immunotoxicity study is required as specified in the new 40 CFR Part 158 data requirements.
   * An immunotoxicity study is required as specified in the new 40 CFR Part 158 data requirements.

9.2	Residue Chemistry
   * 860.1200 Directions for Use
         o A revised Section B for PP#0E7723 should be submitted which:
               # prohibits the use of novaluron on turnips harvested for the root and prohibits the feeding of turnip tops to livestock as previously requested (Memo, J. Van Alstine, 09-SEP-2009; D357060).  This affects the current petition because it could result in increased livestock dietary burdens.

         o A revised Section B for PP#0F7708 should be submitted which:
               # specifies an application rate of 0.1 gallons per 1000 ft[2] for indoor spot, crack and crevice, space spray, and general surface applications;
               # states that all food processing surfaces (including equipment) and utensils should be covered during treatment or thoroughly washed prior to use;
               # states the livestock feed items should be removed or covered prior to application; and
               # removes all references to fogger and fog applications in the label and specifies that applications should be made with mechanical cold mist/ULV equipment.

   * 860.1550 Proposed Tolerances
         o A revised Section F for PP#0E7723 should be submitted which:
               # cites the appropriate CAS name for novaluron:
               "Tolerances are established for residues of the insecticide novaluron, including its metabolites and degradates, in or on the commodities in the table below.  Compliance with the tolerance levels specified below is to be determined by measuring only novaluron (N-[[[3-chloro-4-[1,1,2-trifluoro-2-(trifluoromethoxy)ethoxy]phenyl]amino]carbonyl]-2,6-difluorobenzamide) in or on the following raw agricultural commodities:"; and

               # reflects the recommended tolerances and commodity definitions presented in Table 14.

         o Additionally, a revised Section F for PP#0F7708 should be submitted which:
               # reflects the commodity definition presented in Table 14.
   * 860.1650 Submittal of Analytical Reference Standards
         o The available analytical reference standards for novaluron have expired.  MANA is required to submit an updated COA or a new analytical standard to the EPA National Pesticide Standards Repository at the following address:

               USEPA
               National Pesticide Standards Repository/Analytical Chemistry Branch/OPP
               701 Mapes Road
               Fort George G. Meade, MD  20755-5350

               Please note that the extended zip code is required for delivery.

Note to RD:  Based on ChemSAC guidance that meat byproduct tolerances should be set at the highest residue level seen in any livestock commodity (minutes from 12-JAN-2011), several meat byproduct tolerances in 40 CFR § 180.598 (a) should be updated so that they are based on the highest expected residue.  Additionally, two commodity descriptions should be updated.  The tolerances and commodity descriptions should be updated as follows:

                         Current Commodity Description
                         Updated Commodity Description
                            Current Tolerance (ppm)
                          Updated Tolerance (ppm)[1]
Cattle, meat byproducts, except kidney and liver
                                       -
                                     0.60
                                      11
Goat, meat byproducts except kidney and liver
                                       -
                                     0.60
                                      11
Horse, meat byproducts, except kidney and liver
                                       -
                                     0.60
                                      11
Sheep, meat byproducts, except kidney and liver
                                       -
                                     0.60
                                      11
Hog, meat byproducts
Hog, meat byproducts, except kidney and liver[2]
                                     0.10
                                      1.5
Poultry, meat byproducts
Poultry, meat byproducts, except kidney and liver[3]
                                     0.80
                                      7.0
1 Based on the based on the highest expected secondary tissue residue [peritoneal fat in cattle (translated to goat, horse, and sheep); peritoneal fat in hog; abdominal fat in poultry].
2 Separate tolerances have been established for hog, kidney (0.10 ppm) and hog, liver (0.10 ppm).
[3] Separate tolerances have been established for poultry, kidney (0.80 ppm) and poultry, liver (0.80 ppm).

9.3	Occupational and Residential Exposure

   * A revised label (Section B) for PP#0E7723 should be submitted:
               o             which specifies that the retreatment of sweet corn with novaluron is prohibited (i.e., only 1 application is allowed at a rate of 0.078 lb ai/A) in California and other arid areas which receive less than 20 inches of precipitation per year.
   * A revised label (Section B) should also be submitted for PP#0F7708 which:
               o            specifies an application rate of 0.1 gallons per 1000 ft[2] for indoor spot, crack and crevice, space spray, and general surface applications; and
               o             requires the addition of chemical-resistant gloves.

Attachments:

Appendix A:  TOXICOLOGY ASSESSMENT
A.1	Acute Toxicity Profile.
A.2	Toxicity Profiles.

cc: L. Venkateshwara, J. Van Alstine,
RDI: RAB1 Branch (03/09/11); G. Kramer (3/7/11); D. Vogel (03/09/11)
L.Venkateshwara:S10956:Potomac Yard 1:703-308-2722:7509P:RAB1
Appendix A:  TOXICOLOGY ASSESSMENT

A.1.	Acute Toxicity Profile

Table A.1.  Acute Toxicity of Novaluron.
Guideline No.
Study Type
MRID #(s)
Results
Toxicity Category
870.1100
(81-1)
Acute Oral (rat)
44961001
LD50 > 5000 mg/kg
IV
870.1200
(81-2)
Acute Dermal (rat)
 45003201
LD50 > 2000 mg/kg
III
870.1300
(81-3)
Acute Inhalation (rat)
45003202
LC50 > 5.15 mg/L
IV
870.2400
(81-4)
Primary Eye Irritation (rabbit)
45003203
Not an eye irritant
IV
870.2500
(81-5 )
Primary Skin Irritation (rabbit)
45003204
Not a dermal irritant
IV
87.2600
(81-6)
Dermal Sensitization (guinea pig)
45084001
Not a dermal sensitizer
N/A

A.2	Toxicity Profiles

Table A.2.  Toxicity Profile of Novaluron.
Guideline No/
Study type

MRID No.(year)/Doses/Classification

Results
870.3100
90-Day oral toxicity rodents
45651504/45651503 (1993/1990);
Acceptable/guideline

Study I: 0, 50, 100, 200, or 400 ppm (equivalent to 0, 3.52, 6.93, 13.03, and
27.77 mg/kg bw/day, respectively in males and 0, 4.38, 8.64, 17.54, and 34.39 mg/kg bw/day, respectively in females)

Study II: 0, 10, 320, or 10,000
ppm (equivalent to 0, 0.7, 22.2, and 713 mg/kg bw/day, respectively in males and 0, 0.8, 24.3, and 754 mg/kg bw/day, respectively in females)
NOAEL = 320 ppm (22.2 mg/kg/day) in males and 50 ppm (4.38 mg/kg/day) in females.

LOAEL = 400 ppm (27.77 mg/kg/day) in males based on increased occurrence of extramedullary hematopoiesis and hemosiderosis in spleen; and 100 ppm (8.64 mg/kg/day) in females based on reduction in hemoglobin, hematocrit, and RBC count; increased occurrence of extramedullary hematopoiesis in the spleen and hemosiderosis in the spleen and liver.
870.3200
28-day Dermal Toxicity - rat
45288501 (1998);
0, 75, 400, 1000 mg/kg/day

Acceptable/Guideline
Systemic NOAEL = 1000 mg/kg/day; LOAEL = not established.

Dermal NOAEL = 1000 mg/kg/day; LOAEL = not established.
870.3700 Prenatal Developmental in rodents-Rat
45082602 (1997);

0, 250, 500, 1000 mg/kg/day

Acceptable/Guideline
Maternal NOAEL = 1000 mg/kg/day; LOAEL = not established.
Developmental NOAEL = 1000 mg/kg/day; LOAEL = not established.
870.3700 Prenatal Developmental in nonrodents-Rabbit
45638316, 45638318, 45638317
(1997,1998);

0, 100, 300, 1000 mg/kg/day

Acceptable/Guideline
Maternal NOAEL = 1000 mg/kg/day; LOAEL = not established.
Developmental NOAEL = 1000 mg/kg/day; LOAEL = not established.

870.3800 Reproduction  and fertility- rat
45651505 (Main Study, 1999), 45638319 (Preliminary Study, 1998);

0, 1000, 4000, or 12,000 ppm ;
M:  0, 74.2, 297.5, or 894.9 mg/kg/day
F:  0, 84.0, 336.7, or 1009.8 mg/kg/day

Acceptable/Guideline
Parental NOAEL = Not established; LOAEL (M/F) = 74.2/84.0 mg/kg/day based on increased absolute and relative spleen weights.

Offspring NOAEL = Not established; LOAEL (M/F) = 74.2/84.0 mg/kg/day based on increased absolute and relative spleen weights.

Reproductive NOAEL (M/F) = 74.2/1009.8 mg/kg/day; LOAEL (M) = 297.5 mg/kg/day based on decreased epididymal sperm counts and increased age of preputial separation in the F1 generation; Reproductive LOAEL for females was not established.
870.4100
Chronic toxicity - dog
45638320 (1999);

0, 10, 100, 1000 mg/kg/day

Acceptable/Guideline
NOAEL = 10 mg/kg/day.
LOAEL = 100 mg/kg/day based on hematologic changes associated with histopathological changes in liver and spleen.
870.4300 Chronic/ Carcinogenicity-rat
45651506 (1995);

0, 25, 700, or 20,000 ppm test material;
M:  0, 1.1, 30.6, and 884.2 mg/kg/day
F:  0, 1.4, 39.5, and 1113.5 mg/kg/day

Acceptable/Guideline
NOAEL (M/F) = 1.1/1.4 mg/kg/day.
LOAEL (M/F) = 30.6/39.5 mg/kg/day based on erythrocyte damage and turnover resulting in a regenerative mild anemia.

870.4300 Chronic/ Carcinogenicity-mouse
45651507/45877901 (2000/2003);

0, 30, 450, or 7000 ppm test material;
M:  0, 3.6, 53.4, or 800.0 mg/kg/day
F:  0, 4.3, 63.3, or 913.4 mg/kg/day

Acceptable/Guideline
NOAEL (M/F) = 3.6/4.3 mg/kg/day.
LOAEL (M/F) = 53.4/63.3 mg/kg/day based on increased erythrocyte turnover due to hemoglobin oxidation and resulting in a mild anemia.
870.5100
Salmonella typhimurium and  Escherichia coli Reverse Mutation Assay
44961013 (1997);

0, 312.5, 625, 1250, 2500, or 5000 μg/plate in the presence and absence of metabolic activation (+-S9)

Acceptable/Guideline
Novaluron, tested up to the limit of solubility (2500 μg/plate) and the limit dose (5000 μg/plate), was not cytotoxic with or without S9 activation in four S. typhimurium strains and one strain of E. coli, and did not induce a genotoxic response in any strain.
870.5100
Salmonella typhimurium- bacterial reverse gene mutation assay
45030003 (1986);

0, 10, 33, 100, 333, 1000, or 3333 μg/plate in the presence and absence of mammalian metabolic activation (+-S9)

Acceptable/Guideline
Novaluron, tested up to the limit of solubility (3333 μg/plate), was not cytotoxic with or without S9 activation in five S. typhimurium strains, and did not induce a genotoxic response in any strain.
870.5300
Gene Mutation
45638321(1989);

0, 50, 100, 125, 150, 175, or 200 μg/mL with and without metabolic activation (S9-mix) in two independent assays.

Acceptable/Guideline
There was no evidence of biologically significant induction of mutant colonies over background.
870.5375
In vitro mammalian chromosome aberration test
44961015 (1992);

40, 200, and 1000 μg/mL, with and without metabolic activation (+-S9)

Acceptable/Guideline
Novaluron produced no evidence of clastogenic activity in primary human lymphocytes, in the presence or absence of S9 activation.
870.5395
Mammalian erythrocyte micronucleus test in mice
45638322(1989);

0, 1250, 2500, or 5000 mg/kg body weight

Acceptable/Guideline
There was no statistically significant increase in the frequency of micronucleated polychromatic erythrocytes in mouse bone marrow at any dose or harvest time.
870.5500
Mutagenicity - Rec assay with Bacillus subtilis
44961014 (1998);

50, 150, 500, 1,500, or 5,000 μg/plate, with and without mammalian metabolic activation (+-S9)

Acceptable/Guideline
Novaluron was equivocal for bacterial DNA damage in the absence of S9 activation, and negative for bacterial DNA damage in the presence of S9 activation.
870.5550
Unscheduled DNA Synthesis in HeLa S3 Human Epitheliod cells
45030002 (1988);

0.125, 0.25, 0.5, 1, 2, 4, 8, 16, 32, 64, 128, or 256 μg/mL (+-S9)

Acceptable/Guideline
Novaluron was considered not to show any evidence of causing DNA damage to HeLa S3 epithelioid cells in this unscheduled DNA synthesis test for mutagenic potential.
870.6200
Acute Neurotoxicity screening battery- rat
45082601 (1999);

0, 200, 650, 2000 mg novaluron/kg

Acceptable/Guideline
NOAEL = 650 mg/kg/day; LOAEL = 2000 mg/kg/day based on clinical signs (piloerection, irregular breathing), FOB parameters (increased head swaying, abnormal gait) and neuropathology (sciatic and tibial nerve degeneration).
870.6200
Subchronic Neurotoxicity screening battery- rat
46086204 (2002);

0, 17.5/20.5, 174/207, 1752/2000 mg/kg/day
(M/F)

Acceptable/Guideline
NOAEL (M/F) = 1752/2000 mg/kg/day; LOAEL = not established.
870.7485
Metabolism-rat
45638401 (2000), 45638323 (1998);

single dose of 2 mg/kg or 1000 mg/kg, or 14 multiple 2 mg/kg/day doses of unlabeled novaluron (Lot no. 970211/4, 99.3% chemical purity) followed by a single dose of radiolabeled novaluron.

Acceptable/Guideline
Novaluron exhibited marginal absorption (16-18%), relatively rapid and complete excretion within 48 hours primarily via the feces and to a lesser extent via urine in rat.  Biliary contribution for fecal excretion appears to be insignificant.  Absorption appeared to be approaching saturation at high doses.  Peak plasma concentration occurred at 2-5 hours.  Urinary metabolite profiles revealed 15 components and 8 components following administration of [chlorophenyl-[14]C]novaluron or [difluorophenyl-[14]C]novaluron, respectively.  The most prevalent urinary metabolite was 2,6-difluorobenzoic acid represented the majority of the urinary radioactivity.  Other components individually represented no more than 5.9% of the dose and most represented considerably less than 1%.  Parent compound was the most prevalent contributor in the feces.  The fecal metabolite profile revealed two metabolites; 3-chloro-4-(1,1,2-trifluoro-2-trifluoromethoxyethoxy)aniline, and 1-[3-chloro-4-(1,1,2-trifluoro-2-trifluoromethoxyethoxy)phenyl]urea.  Quantitatively, these were minor components accounting for <2% of the dose.  In the repeated-dose group, some tissues such as fat contained measurable radioactivity at 168 hours post dose but did not appear to suggest significant potential for bioaccumulation or sequestration at the doses tested.
870.7600
Rat Dermal Penetration
45638415 (2000);

1.0, 0.067, 0.0048, or 0.0003 mg/cm[2]

Acceptable/Guideline
Recovery of administered radioactivity was an acceptable 90.19-105.26%.  The maximum total absorbed dose (expressed as per cent of administered dose and determined as the sum of radioactivity in excreta, cage wash, untreated skin, fat, blood, and residual carcass) ranged from about 0.5% to 10% of that administered.


[Federal Register Volume 83, Number 8 (Thursday, January 11, 2018)]
[Notices]
[Pages 1445-1446]
[FR Doc No: 2018-00304]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82445; File No. SR-Phlx-2017-99]

Self-Regulatory Organizations; Nasdaq PHLX LLC; Order Granting
Accelerated Approval of a Proposed Rule Change To Amend Rule 1059 To
Make Permanent a Program That Allows Cabinet Trade Transactions To Take
Place at a Price Below $1 Per Option Contract

January 5, 2018.

I. Introduction

    On November 29, 2017, Nasdaq PHLX LLC (the ``Exchange'' or
``Phlx'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change amending the Exchange's rules to make permanent a
program that allows transactions to take place in open outcry trading
at prices of at least $0 but less than $1 per option contract (``sub-
dollar cabinet trades''). The proposed rule change was published for
comment in the Federal Register on December 14, 2017.\3\ The Commission
received no comment letters on the proposed rule change. This order
approves the proposed rule change on an accelerated basis.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 82245 (Dec. 8,
2017), 82 FR 58825 (Dec. 14, 2017) (SR-Phlx-2017-99) (``Notice'').
---------------------------------------------------------------------------

II. Description of the Proposed Rule Change

    Prior to 2010, Phlx Rule 1059 (Accommodation Transactions) allowed
cabinet trade transactions at a price of $1 per option contract to
occur in open outcry trading for certain options classes.\4\ In 2010,
the Exchange amended Phlx Rule 1059 on a pilot basis to allow sub-
dollar cabinet trades to take place at prices of at least $0 but less
than $1 per option contract.\5\ The Exchange now proposes to amend Phlx
Rule 1059 to make permanent its sub-dollar cabinet trade pilot program,
which currently is scheduled to expire on January 5, 2018.\6\
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    \4\ See Phlx Rule 1059.
    \5\ See Securities Exchange Act Release No. 63626 (Dec. 30,
2010), 76 FR 812 (Jan. 6, 2011) (SR-Phlx-2010-185).
    \6\ See Commentary .02 to Phlx Rule 1059. See also Securities
Exchange Act Release No. 79782 (January 12, 2017), 82 FR 6667
(January 19, 2017) (SR-Phlx-2017-01).
---------------------------------------------------------------------------

    The Exchange permits sub-dollar cabinet trade transactions to be
traded

pursuant to the same procedures applicable to $1 cabinet trades, except
that for sub-dollar cabinet trades (i) bids and offers for opening
transactions are permitted only to accommodate closing transactions,
and (ii) transactions in option classes participating in the Penny
Pilot Program are permitted.\7\ The Exchange believes that ``allowing a
price of at least $0 but less than $1 better accommodates the closing
of options positions in series that are worthless or not actively
traded, particularly when there has been a significant move in the
price of the underlying security, resulting in a large number of series
being out-of-the-money.'' \8\
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    \7\ See Commentary .02 to Phlx Rule 1059.
    \8\ Notice, supra note 3, at 58826. The Exchange notes that this
is especially true for transactions in options classes in the Penny
Pilot Program, for which cabinet trades are not otherwise permitted.
See id.
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III. Discussion and Commission Findings

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Act \9\ and the rules
and regulations thereunder applicable to a national securities
exchange.\10\ In particular, the Commission finds that the proposed
rule change is consistent with Section 6(b)(5) of the Act,\11\ which
requires, among other things, that the rules of a national securities
exchange be designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general, to protect investors and the public interest.
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    \9\ 15 U.S.C. 78f.
    \10\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \11\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    In the Notice, the Exchange explains that it initially adopted the
sub-dollar cabinet trade rule on a pilot basis to ``evaluate the
efficacy of the change and to address any operational issues that might
arise in processing [c]abinet trades.'' \12\ The Exchange represents
that at the time it adopted the pilot, its system permitted reporting
cabinet trades at prices as small as $0.0001, as it does today.\13\
Based on its experience with these types of trades, the Exchange
represents that its system ``allows [c]abinet trades to be processed in
a manner similar to how all other trades are processed by the
[E]xchange.'' \14\
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    \12\ See Notice, supra note 3, at 58826.
    \13\ See id.
    \14\ Id. See also id. at 58826 (noting that ``in 2016, there
were a total of 442 [c]abinet [t]rades'' on the Exchange
``comprising 244,734 contracts,'' and ``[e]ach contract was executed
at a price of $0.01.'').
---------------------------------------------------------------------------

    In support of making the pilot program permanent, the Exchange
represents that ``there are no operational issues in processing and
clearing [c]abinet [t]rades in penny and sub-penny increments.'' \15\
The Exchange also represents that ``members and member organizations
have not raised any concerns with the processing of [c]abinet trades.''
\16\ Finally, the Exchange represents that it is ``not aware of the
Options Clearing Corporation (``OCC'') having operational issues with
processing [c]abinet trades submitted by the Exchange.'' \17\
---------------------------------------------------------------------------

    \15\ See Notice, supra note 3, at 58826.
    \16\ Id.
    \17\ Id.
---------------------------------------------------------------------------

    Based on the representations of the Exchange, the Commission
believes that permanent approval of the sub-dollar cabinet trade pilot
is consistent with the Act. In particular, the Commission notes that
the Exchange's system allows it to process cabinet trades in the normal
course. Further, the Exchange has not observed any issues or concerns
with sub-dollar cabinet trades at the Exchange level, with and among
its members, or in processing the trades through OCC. Accordingly, the
Exchange's rule appears reasonably designed to remove impediments,
prevent fraudulent and manipulative acts and practices, and foster
cooperation and coordination with persons engaged in facilitating
transactions in securities. Further, permanent approval will continue
to provide investors with choice when considering a cabinet trade,
including the ability to price such trades below $1 per contract.

IV. Accelerated Approval of Proposed Rule Changes

    The Commission finds good cause, pursuant to Section 19(b)(2) of
the Act,\18\ to approve the proposed rule changes prior to the 30th day
after the date of publication of the Notice in the Federal
Register.\19\ The Commission believes that the proposed rule change
does not raise novel regulatory issues. The Commission notes that
earlier this year it approved similar proposed rule changes from NYSE
Arca, Inc.\20\ and NYSE American LLC (formerly known as NYSE MKT LLC)
\21\ making permanent sub-dollar cabinet trade pilot programs. The
Exchange has represented that its system is able to process cabinet
trades similar to the processing of its other trades, it has not
experienced any issues processing cabinet trades at the Exchange or
through OCC, and its members have not expressed concerns. In addition,
the Commission did not receive any comments on the proposed changes.
Accordingly, the Commission finds that good cause exists to approve the
proposed rule changes on an accelerated basis.
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78s(b)(2).
    \19\ As noted above, the Notice was published for comment in the
Federal Register on December 14, 2017 and the comment period closed
on December 29, 2017. Accordingly, the 30th day after publication of
the Notice is January 13, 2018.
    \20\ See Securities Exchange Act Release No. 80615 (May 5,
2017), 82 FR 22036 (May 11, 2017) (SR-NYSEArca-2017-24).
    \21\ See Securities Exchange Act Release No. 80616 (May 5,
2017), 82 FR 22033 (May 11, 2017) (SR-NYSEMKT-2017-13).
---------------------------------------------------------------------------

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\22\ that the proposed rule change (SR-Phlx-2017-99) be, and hereby
is, approved on an accelerated basis.
---------------------------------------------------------------------------

    \22\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
---------------------------------------------------------------------------

    \23\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-00304 Filed 1-10-18; 8:45 am]
 BILLING CODE 8011-01-P