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MEMORANDUM

TO:	Tonisha Dawson, U.S. EPA/OAQPS/SPPD  -  EPA Office of Air Quality Planning and Standards

FROM:	Eastern Research Group, Inc.

DATE:	October 2018

SUBJECT:	Asphalt Storage Tank Controls - Ample Margin Of Safety Analysis
--------------------------------------------------------------------------------

INTRODUCTION
The EPA determined that the maximum acute risk from the asphalt processing and asphalt roofing manufacturing source category is a hazard quotient (HQ) of 4 caused by formaldehyde emissions from four asphalt storage tanks located at one asphalt processing and asphalt roofing manufacturing facility (EPA 2018). To further reduce the risk (or potential risk) due to emissions of formaldehyde from these four asphalt storage tanks, we evaluated the cost and feasibility of: (1) Installing ductwork and routing the exhaust of the four asphalt storage tanks to an existing thermal incinerator, or (2) installing ductwork and routing the exhaust of the four asphalt storage tanks to a single new packed bed scrubber.
ASPHALT STORAGE TANK DETAILS
The four asphalt storage tanks contributing to an acute HQ of 4 (due to formaldehyde emissions) are identified as T014, T015, T016, and T021, and are located at Owens Corning Roofing and Asphalt, LLC in Ohio. Based on the facility air permit and information we received from the CAA section 114 request (ERG 2017), we determined that these asphalt storage tanks are uncontrolled for organic HAP emissions; however, these tanks are controlled by fiber bed filters in order to comply with the 40 CFR 63, subpart LLLLL opacity standard.
INSTALLING DUCTWORK AND ROUTING THE EXHAUST OF THE FOUR ASPHALT STORAGE TANKS TO AN EXISTING THERMAL INCINERATOR
We used the methodology from the sixth edition of the EPA Air Pollution Control Cost Manual (EPA, 2002) to calculate the cost to install ductwork to route the exhaust of the four asphalt storage tanks to an existing thermal incinerator. We assumed the duct and elbow material was 304 stainless steel. We also assumed that each asphalt storage tank would need its own duct (i.e., 500 feet of duct per asphalt storage tank) and used a flow rate of 60 actual cubic feet per minute per tank (which is consistent with the flow rate used in the modeling file). The costs were calculated in 2017 dollars and annualized over 20 years using a 4.75% interest rate. The emission reduction and costs calculated for installing ductwork for the facility are summarized in Table 1 below. Appendix A provides the detailed cost algorithms for the total capital investment (TCI) and total annual cost (TAC) to install ductwork, and summarizes the other key parameters used in the analysis to assess impacts.
Table 1. Cost and Environmental Impacts for Installing Ductwork and Routing Exhaust of T014, T015, T016, and T021 to Existing Thermal Incinerator
              (at Owens Corning Roofing and Asphalt, LLC in Ohio)
                                      TCI
                                      ($)
                                      TAC
                                      ($)
                            Formaldehyde Emissions
                                  (tpy) [(A)]
                       Formaldehyde Emission Reductions
                                  (tpy) [(B)]
                              Cost-Effectiveness
                                    ($/ton)
                                     8,640
                                     7,030
                                   6.90E-02
                                   6.87E-02
                                    102,400
[A]	Formaldehyde emissions were provided by the facility as part of the information we received from the CAA section 114 request (ERG 2017). The facility stated these emissions may be overestimated because it assumes all four tanks are being filled at the same time for 8,760 hours per year; this is not a likely scenario.
[B]	A 99.5% formaldehyde removal efficiency was used which is consistent with the combustion efficiency standard in 40 CFR 63, subpart LLLLL for Group 1 asphalt storage tanks.

INSTALLING DUCTWORK AND ROUTING THE EXHAUST OF THE FOUR ASPHALT STORAGE TANKS TO A SINGLE NEW PACKED BED SCRUBBER
The cost estimate to install a packed bed scrubber is based on information from EPA's Control Cost Manual (EPA, 2002).
The TCI consists of the scrubber tower, packing, and pumps. TCI is driven primarily by gas flowrate. The TCI was updated to 2017 dollars using the Chemical Engineering Plant Cost Index (CEPCI).
The TAC includes caustic, wastewater disposal, water, electricity, maintenance, labor, capital recovery costs, overhead, administrative, property taxes, and insurance. Unit costs for labor and electricity were updated to 2017 dollars using current estimates. Current operating labor rates were estimated based on the occupational employment statistics available online from the U.S. Bureau of Labor Statistics. We used the CEPCI to convert unit costs for water, wastewater disposal, and caustic to 2017 dollars.
The emission reduction and costs calculated for installing ductwork and routing the exhaust of the four asphalt storage tanks to a single new packed bed scrubber is summarized in Table 2. Appendix B provides the detailed cost algorithms for the TCI and TAC to install a packed bed scrubber, and summarizes the other key parameters used in the analysis to assess impacts.
Table 2. Cost and Environmental Impacts for Installing Ductwork and Routing Exhaust of T014, T015, T016, and T021 to a Single New Packed Bed Scrubber
              (at Owens Corning Roofing and Asphalt, LLC in Ohio)
                                      TCI
                                      ($)
                                      TAC
                                      ($)
                            Formaldehyde Emissions
                                  (tpy) [(A)]
                       Formaldehyde Emission Reductions
                                  (tpy) [(B)]
                              Cost-Effectiveness
                                    ($/ton)
                                    153,000
                                    243,000
                                   6.90E-02
                                   6.56E-02
                                   3,705,400
[A]	Formaldehyde emissions were provided by the facility as part of the information we received from the CAA section 114 request (ERG 2017). The facility stated these emissions may be overestimated because it assumes all four tanks are being filled at the same time for 8,760 hours per year; this is not a likely scenario.
[B]	A 95% formaldehyde removal efficiency was used which is consistent with the existing total hydrocarbon mass emission reduction standard in 40 CFR 63, subpart LLLLL for Group 1 asphalt storage tanks.
REFERENCES
EPA. 2002. EPA Air Pollution Control Cost Manual, Section 5.2, Chapter 1. January 2002. EPA/452/B-02-001.
EPA. 2018. Residual Risk Assessment for the Asphalt Processing and Asphalt Roofing Manufacturing Source Categories in Support of the 2018 Risk and Technology Review Proposed Rule. EPA Docket No. EPA - HQ - OAR - 2017 - 0662.
ERG. 2017. Data Received from Clean Air Act Section 114 Request for the Asphalt Processing and Asphalt Roofing Manufacturing Source Categories. EPA Docket No. EPA - HQ - OAR - 2017 - 0662.
ERG. 2018. Clean Air Act Section 112(d)(6) Review for the Asphalt Processing and Asphalt Roofing Manufacturing Source Categories. EPA Docket No. EPA - HQ - OAR - 2017 - 0662.

                                  Appendix A

Detailed Cost Algorithms for TCI And TAC of Installing Ductwork and Routing Exhaust of T014, T015, T016, and T021 to Existing Thermal Incinerator (at Owens Corning Roofing and Asphalt, LLC in Ohio)

Ductwork Costs[1]

                               Parameters/Costs
                                     Value
                                   Facility
                                     Notes
Initial Inputs

     Gas flow rate (acfm)
                                      --
                                                                            240

     Number of RTOs
                                      --
                                                                              1

Assumptions

     Duct gas velocity (fpm)
                                                                          4,500

See Table 1.3 of OAQPS Cost Manual.
     Duct length (ft)
                                                                          2,000

Assume 500 feet per asphalt storage tank
     No. of elbows (#/100 ft)
                                                                              2

     Total no. of elbows
                                                                             40

     Duct Diameter (ft)
                                      --
                                                                           0.26

     Duct Diameter (in)
                                      --
                                                                           3.13

     Taxes
                                                                           0.03

     Freight
                                                                           0.05

     Ductwork installation factor
                                                                           0.25

Duct Coefficients

See Table 1.9 of OAQPS Cost Manual.
     a
                                                                          0.322

     b
                                                                           1.22

     Straight duct cost ($/ft)
                                      --
 $ 1

     Straight duct cost ($)
                                      --
$ 2,587

Elbow Coefficients

See Table 1.10 of OAQPS Cost Manual.
     a
                                                                           30.4

     b
                                                                         0.0594

     Elbow cost ($/elbow)
                                      --
 $ 37

     Elbow cost ($)
                                      --
 $ 1,464

Cost Escalator

     1993
                                                                          359.2

     2017
                                                                          567.5

     Interest rate
                                                                         0.0475

     Equipment life (yrs)
                                                                             20

     CRF
                                                                         0.0786

Total Ductwork Cost
                                      --
$ 6,400

     Purchased equipment cost
                                      --
$ 6,912

Total Capital Investment

     Per RTO
                                      --
 $ 8,640

     Per facility
                                      --
 $ 8,640

Direct Annual Cost

     Straight duct friction losses (in. W.C.)
                                      --
                                                                         199.39

     Velocity Pressure (VP)
                                                                           1.26

     k Value for 90 Degree Elbows, k90
                                                                           0.33

     k Value for 45 Degree Elbows, k45
                                                                          0.165

     Elbow friction losses (in. W.C.)
                                      --
                                                                          12.43

     Total friction losses (in. W.C.)
                                      --
                                                                         211.82

     Price of electricity ($/kwh)
                                                                         0.0689

     Motor efficiency
                                                                            0.6

     Operating factor (hr/yr)
                                                                           8760

     Electricity cost ($/yr)
                                      --
 $ 6,009

Indirect Annual Cost

     Property taxes
                                                                           0.01
 $ 86

     Insurance
                                                                           0.01
 $ 86

     G&A
                                                                           0.02
 $ 173

     Capital recovery
                                      --
 $ 679

Total Annual Cost

     Per RTO
                                      --
$ 7,033

     Per facility
                                      --
$ 7,033

[1] We used the methodology from the sixth edition of the EPA Air Pollution Control Cost Manual (EPA, 2002) to calculate the cost to install ductwork. We assumed the duct and elbow material was 304 stainless steel. The costs were calculated in 2016 dollars and annualized over 20 years using a 4.75% interest rate.

                                  Appendix B

Detailed Cost Algorithms for TCI And TAC of Installing Ductwork and Routing Exhaust of T014, T015, T016, and T021 to a Single New Packed Bed Scrubber (at Owens Corning Roofing and Asphalt, LLC in Ohio)

                                   Parameter
                               Equation Variable
                                   Equation
                                 Calculations
STREAM AND INPUT DATA

Facility Name

                            Owens Corning Roofing and Asphalt, LLC<PHONE_NUMBER>)
                              TOTAL FOR INDUSTRY
Emission Point

                                Combined Stacks from T014, T015, T016, and T021

State

                                                                             OH

Flowrate (acfm)
AQtot
Facility-specific, based on modeling file
                                                                            240

Flowrate (acfm) (Per Scrubber)
AQ
=AQtot / #Scr
                                                                            240

Operating Hrs
H
Avg. of survey responses
                                                                           8760

Percent FHYD Reduction Required
%Ctrl

                                                                             95

Temp (F)
Tf
Facility-specific, based on modeling file
                                                                            300

Temp (K)
T
=(Tf + 459.67) * 5/9
                                                                            422

Inlet FHYD Loading (lb/hr)
In FHYDtot
Facility-specific, based on modeling file
                                                                    0.962774804

Inlet FHYD Loading (lb/hr) (Per Scrubber)
In FHYDscr
= In FHYDtot / #Scr
                                                                    0.962774804

Inlet FHYD Loading (mole fraction)
In FHYDm
= (In FHYDscr / 60 / MWFHYD) / (AQ * Dens / MWg)
                                                                    1.26895E-06

CAPITAL COST CALCULATIONS

Scrubber Diameter Exponent (S1)
SDC
= (-0.915 - SQRT(-1.144359 - (1.188 * (LOG10((mm * Fp * ((ui / 2.42) ^ 0.2) * MWR^2  * ap^2) / (12960000 * f^2 * 32.2)))))) / (-0.594)
                                                                          -1.32

Ds (Scrubber Diameter)
Ds
= SQRT((240 * Dg * AQ * 10^SDC) / (MWR * Dl * ap * PI * SQRT((Dg / Dl))))
                                                                            0.9

Hpack (Packing Constant)
Hpack
= LN((In FHYDm / ((In FHYDm * (100 - %Ctrl)) / (100-In FHYDm * %Ctrl)))) * (((x * (HpackA ^ BBB)) / (HpackB ^ g)) * (ui^g) / (ug^BBB) * SQRT(HpackC) + ((1 / AFT) * (t * (HpackD ^ bb) * SQRT(HpackE))))
                                                                           35.0

Number of Packed Scrubbers
#Scr
Max flowrate per scrubber is 74,800 acfm
                                                                             1

Hpack - A
HpackA
= (240 *  Dg * AQ) / (PI * Ds^2)
                                                                       1,582.6

Hpack - B
HpackB
= MWR * D * ap
                                                                         2,271

Hpack C
HpackC
= ug / (Dg * Dfg)
                                                                          0.89

Hpack D
HpackD
= (MWR * Dl * ap) / ui
                                                                         1,052

Hpack E
HpackE
= ui / (Dl * Dfl)
                                                                         446.6

TCI - Pack
TCIp
= #Scr * 0.649 * Cp * Hpack * PI * Ds^2 * (1.0506 * 109.4 / 100) * (2017 CEPCI / 389.5)
                                      $                                  1,963

TCI - Pump
TCIpump
= #Scr * 0.0312 * MWR * ap * PI * Ds^2 * CFpump * m * (1.0506 * 109.4 / 100) * (2017 CEPCI / 389.5)
                                     $                                     118

TCI - Tower
TCItower
= #Scr * ((417.956 * m * PI * Ds * Hpack) + (453.7808 * m * PI * Ds^2) + (838.8974 * m * PI * Ds)) * (1.0506 * 109.4 / 100) * (2017 CEPCI / 389.5)
                                       $                                75,695

TCI (scrubber)
TCIscrub
= (TCItower + TCIpump + TCIp) * (Retrofit Factor of 1.4)
                                        $                              108,886

Number of Ductlines
ND
Calculate such that max flowrate per ductline is 154,042 acfm
                                                                             1

Duct Diameter (ft)
Dd
= 1.128 x (AQ / ut)^0.5
                                                                           0.32

TCI - Duct - SS
TCIduct
= #Scr * ND * (1.458 * ((0.39 * ((Dd / ND)^2) * 3.14159 * L) + (74.2 * L * Ne_Ld * EXP(0.8016 * (Dd / ND))) + (23 * EXP(0.6804 * (Dd / ND))) + (af * (Df^b)))) * (2017 CEPCI / 389.5) * (Retrofit factor of 1.4)
                                       $                                20,470

Total Monitoring Cost
TCImon
Parametric monitor capital cost, default applied to all facilities
                                       $                                24,100

TCI (Total)

= TCIscrub + TCIduct + TCImon
 $                            153,456
 $    153,456
ANNUAL COST CALCULATIONS

Cost of Caustic
Ccaus
= #Scr * (0.03 * AQ * Dg * (In FHYDm - (In FHYDm * (100 - %Ctrl) / (100 - In FHYDm * %Ctrl))) * _SR1 * MWc * H * CFc / MWg)
                                   $                                         3

Cost of WW disposal
Cdis
= #Scr * (7.194 * D7 * Dg * (In FHYDm -(In FHYDm * (100 - %Ctrl) / (100 - In FHYDm * %Ctrl))) * _SR2 * MWs * (1 / BF) * H * CFww / MWg)
                                   $                                         0

Cost of solvent (water)
Csolv
= #Scr * (Cdis * (CFwt / CFww))
                                   $                                         0

Cost of labor and supervisor
Clab
= #Scr * (0.07188 * H * CFlab)
                                       $                                50,168

Cost of maintenance
Cmain
= #Scr * (0.125 * H * CFmain)
                                       $                                87,243

Electricity Amount (Fan)
ElecFan
= (0.000117 * AQ * H * (((Hpack * (AQ^2) * cpc * Dg * (10^(j * MWR * Dl * ap / 3600))) / (225* PI^2 * Ds^4)) + (0.136 * (( 1 / Dd)^1.18) *((ut / 1000)^1.8) * (L / 100) + (L) * (Ne_Ld) * k * ((ut / 4016)^2)))) / ef
                                       $                                17,631

Electricity Amount (Pump)
ElecPump
= (0.00000585 * H * PI * Ds^2 * MWR * ap * Pp) / Ep
                                     $                                     413

Electricity Cost (Total)
ElecTot
 = #Scr * CFelec * (ElecFan + ElecPump)
                                      $                                  1,247

Variable Costs
Var
= CCaus + Cdis + Csolv + Clab + Cmain + ElecTot
                                        $                              138,661

Capital Recovery
CapRec
= (TCIscrub * ((I*((1 + I) ^ n)) / (((1 + I) ^ n) - 1)))
                                       $                                10,314

Overhead Cost
Ovrhd
= 0.6 * (Clab + Cmain)
                                       $                                82,447

Administrative Cost
Admin
= 0.02 * TCIscrub
                                      $                                  2,178

Property Tax
Tax
= 0.01 * TCIscrub
                                      $                                  1,089

Insurance
Ins
= 0.01 * TCIscrub
                                      $                                  1,089

Fixed Costs
Fix
= CapRec + Ovrhd + Admin + Tax + Ins
                                       $                                97,116

TAC (scrubber)
TACscr
= Var + Fix
                                        $                              235,777

CRF duct
CRFduct

                                                                          0.079

Duct - Capital Recovery
DuctCR
= TCIduct * CRFduct
                                      $                                  1,608

Duct - Administrative Cost
DuctAdmin
= TCIduct * 0.02
                                     $                                     409

Duct - Property Tax
DuctTax
= TCIduct * 0.01
                                     $                                     205

Duct - Insurance
DuctIns
= TCIduct * 0.01
                                     $                                     205

TAC - Duct
TACduc
= DuctCR + DuctAdmin + DuctTax + DuctIns
                                      $                                  2,427

Annual Monitoring Cost
TACmon
Parametric monitor annual cost, default applied to all facilities
                                      $                                  5,200

TAC (Total)
TAC
= TACscr + TACduc + TACmon
 $                            243,403
 $    243,403
EMISSION REDUCTIONS AND COST-EFFECTIVENESS

Lbs of FHYD Removed per Yr

= H * In HDlscr * (%Ctrl / 100)
                                                                         8,012
              8,012
Dollars per Ton of FHYD Removed

 $                              60,758
 $       60,758

                           PACKED SCRUBBER DEFAULTS
Variable
COMMON DEFAULTS - PACKED SCRUBBER

I
I = interest rate

                                                                         0.0475
2017 CEPCI
2017 CEPCI

                                                                          567.5
Dg
Dg = density of gas, lb/ft3

                                                                         0.0709
Ne_Ld
Ne/LD = # of elbows per length of duct
                                                                           0.02
L
L = length of ductwork

                                                                            500
MWR
MWR = minimum wetting rate, ft2/hr
                                                                            1.3
ut
ut = gas transport velocity, ft/min
                                                                           3000
Dl
Dl = density of liquid, lb/ft3

                                                                           62.4
ap
a = packing constant, ft2/ft3

                                                                             28
Variable
DEFAULTS - TOTAL ANNUAL COST -- PACKED SCRUBBER
n
n = life of equipment, yrs

                                                                             15
SR1
SR1 = moles caustic/moles pollutant
                                                                            0.5
MWc
MWc = caustic molec wt, lb/lb-mole
                                                                             62
CFc
Cfc = cost factor for caustic, $/ton
                                                                            450
MWg
MWg = gas molecular weight, lb/lb-mole
                                                                             29
Dens
gas density, lb/ft3

                                                                          50.88
MWf
Formaldehyde molecular weight, lb/lbmol

                                                                         30.031
SR2
SR2 = moles salt/moles Formaldehyde

                                                                              1
MWs
MWs = salt molecular weight, lb/lb-mole
                                                                           58.5
BF
BF = fraction of waste stream treated
                                                                            0.1
CFww
CFww  = cost factor for ww disposal, $/gal
                                                                         0.0054
CFwt
CFwt = cost factor for water, $/gal
                                                                       0.000591
CFlab
CFlab = cost factor for labor, $/hr
                                                                          79.67
CFmain
CFmain = cost factor for maintenance, $/hr
                                                                          79.67
 Variable
DEFAULTS - ELECTRICITY - PACKED SCRUBBER
CFelec
CFelec = cost factor for electricy, $/kw-hr
                                                                        0.06910
Pp
Pp = pressure of pump, ft of H20
                                                                             60
Ep
Ep = efficiency of pump

                                                                            0.7
cpc
cpc = packing constant

                                                                           0.24
j
j = packing constant

                                                                           0.17
k
k = friction loss factor for elbow

                                                                           0.35
ef
ef = efficiency of fan

                                                                            0.7
 Variable
DEFAULTS - DUCTWORK - PACKED SCRUBBER
af
af = fan coefficient

                                                                           22.1
b
b = fan exponent

                                                                           1.55
Df
Df = fan diameter, inches

                                                                           36.5
n_duct
n_duct = life of equipment, yrs

                                                                             20
Variable
DEFAULTS - TCI - PACKED SCRUBBER

m
m = factor to convert from FRP to other material
                                                                              1
mm
mm = ratio of solvent density to water density
                                                                              1
Fp
Fp = packing factor

                                                                             65
ui
ui = viscosity of liquid, lb/ft-hr

                                                                           2.16
f
f = flooding factor

                                                                            0.7
ug
ug = viscosity of gas, lb/ft-hr

                                                                          0.044
Dfg
Dfg = diffusivity of pollutant in gas, ft2/hr
                                                                          0.698
Dfl
Dfl = diffusivity of pollutant in liquid, ft2/hr
                                                                       0.000078
AFT
AFT = absorption factor

                                                                             17
x
x = packing constant

                                                                           3.82
t
t = packing constant

                                                                         0.0125
g
g = packing constant

                                                                           0.45
BBB
BBB = packing constant

                                                                           0.41
bb
b = packing constant

                                                                           0.22
Cp
Cp = packing cost factor, $/ft3

                                                                             20
CFpump
CFpump = cost factor for pump, $/gpm

                                                                          24.06


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM DATE: February 20, 2002 SUBJECT: Addendum to Drinking Water Assessment for the Tolerance Reassessment (TRED) for Tebuthiuron FROM: Mark Corbin, Environmental Scientist Environmental Risk Branch 1 Environmental Fate and Effects Division (7507C)

THRU: Dana Spatz, Acting Branch Chief Environmental Risk Branch 1 Environmental Fate and Effects Division (7507C)

TO: Paula Deschamp Reregistration Branch II Health Effects Division (7509C)

Wilhelmena Livingston Special Review Branch Special Review and Reregistration Division (7508C)

EFED has completed an addendum to the drinking water assessment for the reassessment of tolerances for the herbicide tebuthiuron submitted to the Health Effects Division (HED). This assessment considers tebuthiuron and its degradates which the Health Effects Division (HED) has determined are of toxicological concern. Compound 104 was identified by the MARC as the only environmental fate degradate of tebuthiuron of toxicological concern. However, insufficient fate data was available for compound 104. Therefore, EFED elected to model total tebuthiuron residues (TTR) using a cumulative residue approach. The assessment strategy adopted in this addendum was designed to assess concentrations of the TTR (tebuthiuron plus compound 104, compound 105, compound 106, compound 107, compound 108, and compound 109) which were detected in the environmental fate studies. The name and chemical structure of the degradates are attached as Appendix A. A cumulative residue approach was employed to provide conservative estimated concentrations in drinking water for tebuthiuron and its degradation products. In this approach, the fate parameters necessary for Tier II modeling are estimated from the total residue data in the environmental fate studies previously submitted. For tebuthiuron, total residue data was evaluated for the aerobic soil metabolism (MRID 41328001) half life, aqueous photolysis (MRID 41305101) half life, aerobic aquatic (MRID 41372501) half life, anaerobic soil metabolism (MRID 41328002) half life, and hydrolysis half lives. Additional fate data (including Koc, Henry's Law constant, vapor pressure, solubility, and molecular weight) were estimated for Compound 104 using published software (Estimation Programs Interface (EPI), Version 3.04, 1999) which estimates fate parameter using published equations. Compound 104 was used as a reference degradate because it was the degradate detected at the highest concentration in the environmental fate studies, is expected to be a highly mobile tebuthiuron residue in soil and aquatic environments based in its chemical structure and the fact that it was the only degradate detected in a Small Scale Retrospective Monitoring study. More detail on EPI estimation techniques may be found at http:// syrres. com/ interkow/ epi. htm.

As with parent tebuthiuron, surface water concentrations of TTR were modeled using the PRZM/ EXAMS (Tier II) programs for pasture/ rangeland using EFEDs standard scenario for alfalfa in Texas. The alfalfa scenario was chosen because its hydrologic and agronomic practices are expected to approximate those of pasture/ rangeland. Groundwater concentrations were modeled using the SCI GROW program. Input parameters used Tier II (PRZM version 3.12/ EXAMS version 2.97.5) modeling were selecting using Agency guidance (" Guidance for Chemistry and Management Practice Input Parameters for Use in Modeling the Environmental Fate and Transport of Pesticides" dated August 6, 2000) and EFED calculated degradation rate constants from review of registrant submitted environmental fate studies as note above.

Tier II (PRZM version 3.12/ EXAMS version 2.97.5) surface water modeling for TTR due to use of tebuthiuron use on rangeland/ pasture at 4 pounds active ingredient per acre (lbs ai/ A) using the index reservoir and a PCA of 0.87 predicts the 1 in 10 year annual maximum (acute) concentration of 15.52 : g/ L. The 1 in 10 year annual average concentration (non cancer chronic) of tebuthiuron is predicted to be 4.31 : g/ L . The 36 year annual average concentration (cancer chronic) of tebuthiuron is predicted to be 1.96 : g/ L. SCI GROW (version 2.1) modeling estimates the acute and chronic concentration of TTR in shallow groundwater is 245 : g/ L.

A comparison of the TTR concentrations compared with the parent only values previously submitted are presented in Table 1. A more detailed modeling discussion is presented in Appendix B. Table 1. Comparison of PRZM EXAMS Predicted Total Tebuthiuron Residue (TTR) Concentrations with Predicted Parent Tebuthiuron Concentrations in the Index Reservoir Simulation Scenarios Concentration ( : g/ L)

1 in 10 year Mean of Annual Means Crop and Location Scenario Peak 96 Hour 21 Day 60 Day 90 Day Annual Mean Pasture, Milam Co., TX Total Residues w/ PCA (0.87) 15.5 15.3 14.3 12.2 10.9 4.3 2.0 Parent Only w/ PCA (0.87) 15.1 14.4 11.5 7.0 5.2 1.5 0.6 Appendix B provides a detailed discussion of the modeling efforts for PRZM/ EXAMS, and SCIGROW APPENDIX A DEGRADATE NAMES and STRUCTURES N N S N CH 3 CH 3 C H 3 C H 3 O NH 2 Table 1. Degradates of Tebuthiuron with maximum applied detected in each study:

Parent / Degradate Name and Structure Percent of Applied Dose MRID # Study Type Reported Values Maximum Day *104: N[ 5( 1,1 dimethylethyl) 1,3,4 thiadiazol 2 yl] methylurea ND N/ A N/ A hydrolysis ND N/ A 41305101 aqueous photolysis 6.8 14 41050201 soil photolysis 6.9 270 41328001 aerobic soil Nmetabolism 2.9 60 41328002 anaerobic soil metabolism 1.5 21 41372501 aerobic aquatic metabolism ND N/ A 41913101 anaerobic aquatic metabolism ND N/ A 40768401 batch equilibrium N/ A N/ A N/ A laboratory volatility N/ A N/ A N/ A field volatility 22.9 408 43318101 terrestrial field dissipation 2.2 (edible) 21 40819501 bioaccumulation in fish 105: N[ 5( 1,1 dimethylethyl) 1,3,4 thiadiazol 2 yl] N methylurea ND N/ A N/ A hydrolysis ND N/ A 41305101 aqueous photolysis 3.5 19 41050201 soil photolysis 0.4 90 41328001 aerobic soil metabolism 0.2 60 41328002 anaerobic soil metabolism 0.4 28 41372501 aerobic aquatic metabolism ND N/ A 41913101 anaerobic aquatic metabolism ND N/ A 40768401 batch equilibrium Parent / Degradate Name and Structure Percent of Applied Dose MRID # Study Type Reported Values Maximum Day N N S N H CH 3 C H 3 C H 3 O NH 2 N/ A N/ A N/ A laboratory volatility N/ A N/ A N/ A field volatility ND N/ A 43318101 terrestrial field dissipation 4.7 (edible) 21 40819501 bioaccumulation in fish 106: N[ 5( 1,1 dimethylethyl) 1,3,4 thiadiazol 2 yl] urea ND N/ A N/ A hydrolysis ND N/ A 41305101 aqueous photolysis 2.7 5 41050201 soil photolysis ND N/ A 41328001 aerobic soil metabolism ND N/ A 41328002 anaerobic soil metabolism ND N/ A 41372501 aerobic aquatic metabolism ND N/ A 41913101 anaerobic aquatic metabolism ND N/ A 40768401 batch equilibrium N/ A N/ A N/ A laboratory volatility N/ A N/ A N/ A field volatility ND N/ A 43318101 terrestrial field dissipation ND N/ A 40819501 bioaccumulation in fish 107: 5( 1,1 Dimethylethyl) 2 methylamino 1,3,4 thiadiazole ND N/ A N/ A hydrolysis ND N/ A 41305101 aqueous photolysis ND N/ A 41050201 soil photolysis 1.1 270 41328001 aerobic soil metabolism ND N/ A 41328002 anaerobic soil metabolism Parent / Degradate Name and Structure Percent of Applied Dose MRID # Study Type Reported Values Maximum Day N N S NH 2 CH 3 C H 3 C H 3 0.3 21 41372501 aerobic aquatic metabolism ND N/ A 41913101 anaerobic aquatic metabolism ND N/ A 40768401 batch equilibrium N/ A N/ A N/ A laboratory volatility N/ A N/ A N/ A field volatility ND N/ A 43318101 terrestrial field dissipation ND N/ A 40819501 bioaccumulation in fish 108: 2 dimethylethyl 5 amino 1,3,4 thiadiazole ND N/ A N/ A hydrolysis ND N/ A 41305101 aqueous photolysis ND N/ A 41050201 soil photolysis 0.6 270 41328001 aerobic soil metabolism ND N/ A 41328002 anaerobic soil metabolism 0.1 7 41372501 aerobic aquatic metabolism ND N/ A 41913101 anaerobic aquatic metabolism ND N/ A 40768401 batch equilibrium N/ A N/ A N/ A laboratory volatility N/ A N/ A N/ A field volatility ND N/ A 43318101 terrestrial field dissipation ND N/ A 40819501 bioaccumulation in fish Parent / Degradate Name and Structure Percent of Applied Dose MRID # Study Type Reported Values Maximum Day N N S N CH 3 CH 3 C H 3 C H 3 O N H OH N N S N CH 3 CH 3 C H 3 C H 3 O N H CH 3 N N S N CH 3 CH 3 C H 3 O N H CH 3 OH *109: N[ 5( 1,1 dimethylethyl) 1,3,4 thiadiazol 2 yl] hydroxymethyl methylurea ND N/ A N/ A hydrolysis ND N/ A 41305101 aqueous photolysis ND N/ A 41050201 soil photolysis N'ND N/ A 41328001 aerobic soil Nmetabolism 0.2 60 41328002 anaerobic soil metabolism 0.3 7 41372501 aerobic aquatic metabolism ND N/ A 41913101 anaerobic aquatic metabolism ND N/ A 40768401 batch equilibrium N/ A N/ A N/ A laboratory volatility N/ A N/ A N/ A field volatility ND N/ A 43318101 terrestrial field dissipation 40.1 (edible) 21 40819501 bioaccumulation in fish Attachment 1: Additional structures of tebuthiuron and its metabolites:

Tebuthiuron (103): [N[ 5( 1,1 dimethylethyl 1,3,4 thiadiazol 2 yl] N, N' dimethylurea Matrices: grass forage and hay, ruminant and milk 103 (OH): N[ 5( 2 hydroxy 1,1 dimethylethyl 1,3,4 thiadiazol 2 yl] N, N' dimethylurea Matrices: ruminant and milk N N S N CH 3 CH 3 C H 3 O NH 2 OH N N S N CH 3 CH 3 C H 3 O N H OH OH N N S N C CH3 H3C CH3 H C O N CH3 H Tebuthiuron 105 N N S N C CH3 H3C CH3 H CH3 Tebuthiuron 107 104 (OH): N[ 5( 2 hydroxy 1,1 dimethylethyl 1,3,4 thiadiazol 2 yl] N methylurea Matrices: milk A [109 (OH)]: N[ 5( 2 hydroxy 1,1 dimethylethyl) 1,3,4 thiadiazol 2 yl] N hydroxymethyl N methylurea Matices: milk 105: N[ 5( 1,1 dimethylethyl) 1,3,4 thiadiazol 2 yl N' methylurea Matrices: water 107: 5( 1,1 Dimethylethyl) 2 methylamino 1,3,4 thiadi azol e Matr ices :wat er and tissu es cc: SF, RF, List A files, S. Piper, M. Corbin RDI: FBSuhre: /01; MARC: /01 7509C: CEB: CM 2: Room 810F: 308 2717: Tebuthiuron APPENDIX B MODELING DISCUSSION DRINKING WATER ASSESSMENT Uncertainties, Assumptions and Limitations Input parameters used in Tier II (PRZM/ EXAMS) modeling were selecting using Agency guidance (" Guidance for Chemistry and Management Practice Input Parameters for Use in Modeling the Environmental Fate and Transport of" dated August 6, 2000) and EFED calculated degradation rate constants from review of registrant submitted environmental fate studies.

Tebuthiuron is used primarily on pasture and rangeland in Texas, Oklahoma, and New Mexico, therefore, only one scenario was simulated to estimate runoff concentrations. EFED selected a scenario in Texas for alfalfa representing an EFED standard scenario developed for use in modeling the respective crops and is expected to be the standard scenario in the tebuthiuron use with the highest runoff potential. Alfalfa was selected as the scenario most closely representing pasture/ rangeland (the alfalfa scenario was developed based on a pasture setting). These scenarios were developed to approximately represent the 90 th percentile site for runoff vulnerability in a high usage state. Application timing was taken from registrant provided information and recent labels.

The standard scenario for alfalfa is based on usage patterns in Milam County, Texas. The soil is a Lufkin sandy loam in Major Land Use Area (MLRA) 87. The Lufkin sandy loam is characterized as a Hydrologic Group D soil.

Uncertainties, Assumptions and Limitations There are several uncertainties and assumptions in the assessment of tebuthiuron and its degradates. Primary among these is the lack of environmental fate data for the transformation products of tebuthiuron. In order to address this uncertainty, EFED has conducted the Tier II modeling (PRZM/ EXAMS) on the summed tebuthiuron residues (tebuthiuron and its identifiable degradation products including compound 104, compound 105, compound 106, compound 107, compound 108, and compound 109) instead of individual residues. Although the persistence of the tebuthiuron residues was estimated from registrant submitted environmental fate data, the mobility of tebuthiuron residues was estimated using the degradate compound 104 (N[ 5( 1,1 dimethylethyl) 1,3,4 thiadiazol 2 yl] N methylurea) as a reference compound. This compound was used to assess mobility because it was the degradate detected at the highest concentration in the environmental fate studies, is expected to be a highly mobile tebuthiuron residue in soil and aquatic environments, and was the only degradate detected in a Retrospective Ground Water Study. EFED used the lowest Kd/ Koc value for tebuthiuron as the Kd/ Koc for Compound 104. Physical chemistry parameters were estimated for compound 104 (Estimation Programs Interface (EPI), Version 3.04, 1999) and degradation rate constants were estimated by performing linear regression on the total residues (Microsoft Excel 2000) from several fate studies. Table A 1. Input Parameters for Total Tebuthiuron Residues for PRZM (Version 3.12) for Index Reservoir and PCA.

Variable Description Variable (Units) Input Value Source of Info/ Reference Application date( s) (day/ mo/ yr) APD, APM, IAPYR (day/ mo/ yr) 1 times per year Product label or location specific Incorporation depth DEPI (cm) 0 Product label Application rate TAPP (kg a. i. ha 1 ) 4.48 Aerial granular Product label Application efficiency APPEFF (decimal) 1.00 Spray Drift Task Force Data Spray drift fraction: For aquatic ecological exposure assessment, use 0.05 for aerial spray; 0.01 for ground spray. For drinking water assessment, use 0.16 for aerial 0.064 for ground spray. DRFT (decimal) 0.00 Spray Drift Task Force Data Foliar extraction FEXTRA (frac./ cm rain) 0.5 (default) Default or field data Decay rate on foliage PLDKRT (day 1 ) 0.0 (default) Default or field data Volatilization rate from foliage PLVKRT (day 1 ) 0.0 (default) Default or field data Plant uptake factor UPTKF (frac. of evap) 0.0 (default) Default or field data Dissolved phase pesticide decay rate in surface horizon (aerobic soil metabolism) DWRATE (surface) (day 1 ) T1/ 2 => 2832 days Rate constant = 0.000245/ day MRID 41328001 Adsorbed phase pesticide decay rate in surface horizon (aerobic soil metabolism) DSRATE (surface) (day 1 ) T1/ 2 => 2832 days Rate constant = 0.000245/ day MRID 41328001 Dissolved phase pesticide decay rate in subsequent subsurface horizons (aerobic or anaerobic soil metabolism) DWRATE (subsurface horizons) (day 1 ) T1/ 2 => 2832 days Rate constant = 0.000245/ day MRID 41328001 Adsorbed phase pesticide decay rate in subsequent subsurface horizons (aerobic or anaerobic soil metabolism) DSRATE (subsurface horizons) (day 1 ) T1/ 2 => 2832 days Rate constant = 0.000245/ day MRID 41328001 Pesticide partition or distribution coefficients for each horizon (Leaching/ Adsorption/ Desorption) Kd 0.11 Lowest Kd MRID 40768401 Table A 2. Input Parameters for Tebuthiuron. chm Files Used in EXAMS (Version 2.97. 5) for Index Reservoir and PCA.

Variable Description Variable (Units) Input Value Source of Info/ Reference Henry's law constant HENRY (atm m 3 mole 1 ) 7.58 x 10 11 Atm m 3 /mol EPI Bacterial biolysis in water column (aerobic aquatic metabolism) KBACW (cfu/ mL) 1 hour 1 683 days Rate constant =0.000042/ hr MRID 41372501 Bacterial biolysis in benthic sediment (anaerobic aquatic or aerobic aquatic metabolism) KBACS 1 (cfu/ mL) 1 hour 1 0 days (stable) MRID 41913101 Direct photolysis (aqueous photolysis) KDP (hour 1 ) T1/ 2 =0 days (stable) MRID 41365101 Base hydrolysis KBH (mole 1 hour 1 ) 0 days (stable) 1994 RED Neutral hydrolysis KNH (mole 1 hour 1 ) 0 days (stable) 1994 RED Acid hydrolysis KAH (mole 1 hour 1 ) 0 days (stable) 1994 RED Partition coefficient for sediments (Leaching/ Adsorption/ Desorption) need Kd from soil closest to crop scenario KPS (mL g 1 or L kg 1 ) Kd = 0.11 Lowest Kd MRID 40768401 Molecular weight MWT (g mole 1 ) 214.3 EPI Aqueous solubility (Multiply water solubility by 10) SOL (mg L 1 ) = 0.800 2790 ppm @ 20° C EPI Vapor pressure VAPR (torr) 7.5 x 10 7 Torr EPI Sediment bacteria temperature coefficient QTBAS 2 Standard value Water bacteria temperature coefficient QTBAW 2 Standard value TX Alfalf  08/ 06/ 2001 " Texas Claypan Area, Milam County, Texas; MLRA J 87" *** Record 3: 0.71 0.36 0 25 1 1 *** Record 6  ERFLAG 4 *** Record 7: 0.43 0.109 1 172.8 4 1 600 *** Record 8 1 *** Record 9 1 0.25 100 100 1 90 88 89 0 76 *** Record 9a d 1 26 0101 1601 0102 1602 0103 1503 1603 0104 1604 0105 1605 0106 1506 1606 0107 1607 .003 .003 .003 .004 .004 .004 .003 .001 .000 .001 .001 .000 .001 .001 .000 .000 .110 .110 .110 .110 .110 .110 .110 .110 .110 .110 .110 .110 .110 .110 .110 .110 0108 1608 0109 1609 0110 1610 0111 1611 0112 1612 .001 .000 .000 .001 .001 .002 .002 .002 .003 .003 .110 .110 .110 .110 .110 .110 .110 .110 .110 .110 *** Record 10  NCPDS, the number of cropping periods 36 *** Record 11 300847 201047 010848 1 300848 201048 010849 1 300849 201049 010850 1 300850 201050 010851 1 300851 201051 010852 1 300852 201052 010853 1 300853 201053 010854 1 300854 201054 010855 1 300855 201055 010856 1 300856 201056 010857 1 300857 201057 010858 1 300858 201058 010859 1 300859 201059 010860 1 300860 201060 010861 1 300861 201061 010862 1 300862 201062 010863 1 300863 201063 010864 1 300864 201064 010865 1 300865 201065 010866 1 300866 201066 010867 1 300867 201067 010868 1 300868 201068 010869 1 300869 201069 010870 1 300870 201070 010871 1 300871 201071 010872 1 300872 201072 010873 1 300873 201073 010874 1 300874 201074 010875 1 300875 201075 010876 1 300876 201076 010877 1 300877 201077 010878 1 300878 201078 010879 1 300879 201079 010880 1 300880 201080 010881 1 300881 201081 010882 1 300882 201082 010883 1 *** Record 12  PTITLE Tebuthiuron  1 applications @ 4.48 kg/ ha *** Record 13 36 1 0 0 *** Record 15  PSTNAM Tebuthiuron *** Record 16 050648 0 8 2 4.48 1 0 050649 0 8 2 4.48 1 0 050650 0 8 2 4.48 1 0 050651 0 8 2 4.48 1 0 050652 0 8 2 4.48 1 0 050653 0 8 2 4.48 1 0 050654 0 8 2 4.48 1 0 050655 0 8 2 4.48 1 0 050656 0 8 2 4.48 1 0 050657 0 8 2 4.48 1 0 050658 0 8 2 4.48 1 0 050659 0 8 2 4.48 1 0 050660 0 8 2 4.48 1 0 050661 0 8 2 4.48 1 0 050662 0 8 2 4.48 1 0 050663 0 8 2 4.48 1 0 050664 0 8 2 4.48 1 0 050665 0 8 2 4.48 1 0 050666 0 8 2 4.48 1 0 050667 0 8 2 4.48 1 0 050668 0 8 2 4.48 1 0 050669 0 8 2 4.48 1 0 050670 0 8 2 4.48 1 0 050671 0 8 2 4.48 1 0 050672 0 8 2 4.48 1 0 050673 0 8 2 4.48 1 0 050674 0 8 2 4.48 1 0 050675 0 8 2 4.48 1 0 050676 0 8 2 4.48 1 0 050677 0 8 2 4.48 1 0 050678 0 8 2 4.48 1 0 050679 0 8 2 4.48 1 0 050680 0 8 2 4.48 1 0 050681 0 8 2 4.48 1 0 050682 0 8 2 4.48 1 0 050683 0 8 2 4.48 1 0 *** Record 17 0 1 0 *** Record 19  STITLE Lufkin Sandy Loam; HYDG: D *** Record 20 100 0 0 0 0 0 0 0 0 0 *** Record 26 0 0 0 *** Record 33 3 1 10 1.55 0.215 0 0 0 0.00022 0.00022 0 0.1 0.215 0.105 1.16 0.11 2 8 1.55 0.215 0 0 0 0.00022 0.00022 0 1 0.215 0.105 1.16 0.11 3 82 1.6 0.32 0 0 0 0.00022 0.00022 0 2 0.32 0.2 0.29 0.11 *** Record 40 0 YEAR 10 YEAR 10 YEAR 10 1 1 1  7 YEAR PRCP TCUM 0 0 RUNF TCUM 0 0 INFL TCUM 1 1 ESLS TCUM 0 0 1.0E3 RFLX TCUM 0 0 1.0E5 EFLX TCUM 0 0 1.0E5 RZFX TCUM 0 0 1.0E5 SET MODE = 3 CHEM NAME IS Tebuthiuron 104 Read ENV c:\ mark\ przmexam\ exam\ irtxalf. exv SET MWT(*) = 214.3 SET SOL(*,*) = 2790.0 SET PRBEN = 0.05 SET VAPR( 1)= 7.50E 07 SET HENRY( 1) = 7.58E 11 SET KBACW(*,*, 1)= 0.000042 SET KBACS(*,*, 1)= 0.0 SET QTBAS(*,*, 1)= 2.0 SET QTBAW(*,*, 1)= 2.0 SET KDP(*, 1)= 0.0 SET KBH(*,*, 1)= 0.000 SET KNH(*,*, 1)= 0.000 SET KAH(*,*, 1)= 0.000 SET Koc( 1)= 15.69 SET YEAR1 = 1948 READ PRZM P2E C1. D48 RUN READ PRZM P2E C1. D49 CONTINUE READ PRZM P2E C1. D50 CONTINUE READ PRZM P2E C1. D51 CONTINUE READ PRZM P2E C1. D52 CONTINUE READ PRZM P2E C1. D53 CONTINUE READ PRZM P2E C1. D54 CONTINUE READ PRZM P2E C1. D55 CONTINUE READ PRZM P2E C1. D56 CONTINUE READ PRZM P2E C1. D57 CONTINUE READ PRZM P2E C1. D58 CONTINUE READ PRZM P2E C1. D59 CONTINUE READ PRZM P2E C1. D60 CONTINUE READ PRZM P2E C1. D61 CONTINUE READ PRZM P2E C1. D62 CONTINUE READ PRZM P2E C1. D63 CONTINUE READ PRZM P2E C1. D64 CONTINUE READ PRZM P2E C1. D65 CONTINUE READ PRZM P2E C1. D66 CONTINUE READ PRZM P2E C1. D67 CONTINUE READ PRZM P2E C1. D68 CONTINUE READ PRZM P2E C1. D69 CONTINUE READ PRZM P2E C1. D70 CONTINUE READ PRZM P2E C1. D71 CONTINUE READ PRZM P2E C1. D72 CONTINUE READ PRZM P2E C1. D73 CONTINUE READ PRZM P2E C1. D74 CONTINUE READ PRZM P2E C1. D75 CONTINUE READ PRZM P2E C1. D76 CONTINUE READ PRZM P2E C1. D77 CONTINUE READ PRZM P2E C1. D78 CONTINUE READ PRZM P2E C1. D79 CONTINUE READ PRZM P2E C1. D80 CONTINUE READ PRZM P2E C1. D81 CONTINUE READ PRZM P2E C1. D82 CONTINUE READ PRZM P2E C1. D83 CONTINUE QUIT Tebuthiuron Total Residues on Texas Pasture WATER COLUMN DISSOLVED CONCENTRATION (PPB)

YEAR PEAK 96 HOUR 21 DAY 60 DAY 90 DAY YEARLY        1948 4.843 4.762 4.514 3.926 3.511 1.338 1949 1.543 1.517 1.432 1.234 1.107 0.705 1950 10.530 10.350 9.641 8.230 7.331 2.902 1951 21.930 21.560 20.080 17.130 15.440 6.395 1952 10.370 10.200 9.497 8.111 7.227 3.798 1953 2.216 2.179 2.030 1.734 1.548 1.066 1954 0.491 0.484 0.454 0.396 0.357 0.204 1955 9.048 8.910 8.335 7.126 6.350 2.446 1956 1.610 1.586 1.486 1.289 1.160 0.578 1957 9.920 9.753 9.082 7.767 6.923 2.612 1958 5.094 5.008 4.668 3.991 3.558 1.841 1959 4.532 4.455 4.146 3.628 3.253 1.520 1960 17.620 17.320 16.200 13.840 12.340 5.088 1961 7.075 6.996 6.646 5.702 5.085 2.951 1962 16.710 16.490 15.500 13.260 11.820 4.894 1963 3.133 3.085 2.892 2.508 2.258 1.199 1964 9.535 9.374 8.756 7.494 6.681 2.599 1965 2.535 2.493 2.322 1.984 1.777 1.143 1966 3.153 3.100 2.888 2.471 2.210 0.974 1967 3.887 3.820 3.553 3.140 2.905 1.274 1968 1.029 1.013 0.950 0.823 0.742 0.414 1969 9.976 9.808 9.127 7.989 7.465 2.969 1970 2.528 2.490 2.333 2.022 1.820 0.853 1971 8.444 8.302 7.727 6.693 6.009 2.374 1972 6.418 6.310 5.879 5.030 4.486 2.192 1973 3.866 3.801 3.562 3.046 2.715 1.372 1974 1.297 1.287 1.211 1.038 0.929 0.537 1975 4.384 4.313 4.019 3.434 3.060 1.313 1976 5.983 5.882 5.528 4.736 4.233 1.850 1977 1.284 1.265 1.185 1.028 0.925 0.516 1978 18.350 18.040 16.800 14.350 12.800 4.902 1979 3.417 3.359 3.221 2.890 2.624 1.952 1980 0.888 0.875 0.821 0.713 0.642 0.342 1981 33.960 33.630 31.500 26.900 23.960 9.423 1982 6.936 6.820 6.522 5.625 5.022 3.505 1983 2.598 2.554 2.384 2.044 1.827 1.059 SORTED FOR PLOTTING

PROB PEAK 96 HOUR 21 DAY 60 DAY 90 DAY YEARLY        0.027 33.960 33.630 31.500 26.900 23.960 9.423 0.054 21.930 21.560 20.080 17.130 15.440 6.395 0.081 18.350 18.040 16.800 14.350 12.800 5.088 0.108 17.620 17.320 16.200 13.840 12.340 4.902 0.135 16.710 16.490 15.500 13.260 11.820 4.894 0.162 10.530 10.350 9.641 8.230 7.465 3.798 0.189 10.370 10.200 9.497 8.111 7.331 3.505 0.216 9.976 9.808 9.127 7.989 7.227 2.969 0.243 9.920 9.753 9.082 7.767 6.923 2.951 0.270 9.535 9.374 8.756 7.494 6.681 2.902 0.297 9.048 8.910 8.335 7.126 6.350 2.612 0.324 8.444 8.302 7.727 6.693 6.009 2.599 0.351 7.075 6.996 6.646 5.702 5.085 2.446 0.378 6.936 6.820 6.522 5.625 5.022 2.374 0.405 6.418 6.310 5.879 5.030 4.486 2.192 0.432 5.983 5.882 5.528 4.736 4.233 1.952 0.459 5.094 5.008 4.668 3.991 3.558 1.850 0.486 4.843 4.762 4.514 3.926 3.511 1.841 0.514 4.532 4.455 4.146 3.628 3.253 1.520 0.541 4.384 4.313 4.019 3.434 3.060 1.372 0.568 3.887 3.820 3.562 3.140 2.905 1.338 0.595 3.866 3.801 3.553 3.046 2.715 1.313 0.622 3.417 3.359 3.221 2.890 2.624 1.274 0.649 3.153 3.100 2.892 2.508 2.258 1.199 0.676 3.133 3.085 2.888 2.471 2.210 1.143 0.703 2.598 2.554 2.384 2.044 1.827 1.066 0.730 2.535 2.493 2.333 2.022 1.820 1.059 0.757 2.528 2.490 2.322 1.984 1.777 0.974 0.784 2.216 2.179 2.030 1.734 1.548 0.853 0.811 1.610 1.586 1.486 1.289 1.160 0.705 0.838 1.543 1.517 1.432 1.234 1.107 0.578 0.865 1.297 1.287 1.211 1.038 0.929 0.537 0.892 1.284 1.265 1.185 1.028 0.925 0.516 0.919 1.029 1.013 0.950 0.823 0.742 0.414 0.946 0.888 0.875 0.821 0.713 0.642 0.342 0.973 0.491 0.484 0.454 0.396 0.357 0.204 1/ 10 17.839 17.536 16.380 13.993 12.478 4.958 MEAN OF ANNUAL VALUES = 2.253 STANDARD DEVIATION OF ANNUAL VALUES = 1.941 UPPER 90% CONFIDENCE LIMIT ON MEAN = 2.732 RUN No. 1 FOR Compound 104 INPUT VALUES

APPL (#/ AC) APPL. URATE SOIL SOIL AEROBIC RATE NO. (#/ AC/ YR) KOC METABOLISM (DAYS)

.276 1 .276 16.0 2832.0 GROUND WATER SCREENING CONCENTRATIONS IN PPB

245.181800

A= 1500.000 B= 20.960 C= 3.176 D= 1.321 RILP= 8.508 F= 2.949 G= 888.340 URATE= .276 GWSC= 245.181800


[Federal Register Volume 84, Number 63 (Tuesday, April 2, 2019)]
[Notices]
[Pages 12619-12621]
[FR Doc No: 2019-06323]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1107]

Youth Tobacco Cessation: Science and Treatment Strategies; Public
Scientific Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public scientific workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
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available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Allison Hoffman, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3138, Silver
Spring, MD 20993,<PHONE_NUMBER>, [email protected] (please use
``Youth Tobacco workshop'' as the subject line).

SUPPLEMENTARY INFORMATION:

I. Background

    Nearly all tobacco product use begins during youth and young
adulthood (Ref. 1). In 2017-2018, there was an alarming increase in
tobacco product use among adolescents, primarily driven by e-cigarette
use (Refs. 2 and 3). Youth tobacco use raises a number of health
concerns including risk of addiction to nicotine early on in life,
potential harm to the developing adolescent brain, and exposure to
chemicals, including carbonyl compounds and volatile organic compounds
known to have adverse health effects. The full range of possible health
effects is not yet completely understood (Ref. 4).
    On April 24, 2018, FDA announced its Youth Tobacco Prevention
Plan.\1\ This plan focuses on three key strategies: Prevention of youth
access to tobacco products, curbing the marketing of tobacco products
aimed at youth, and educating teens about the dangers of using any
tobacco products, as well as educating retailers about their key role
in protecting youth.\2\ FDA recently launched an expansion of its ``The
Real Cost'' campaign to educate youth on the dangers of e-cigarette use
\3\ and increased enforcement actions to address this critically
important public health concern.\4\
---------------------------------------------------------------------------

    \1\ https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm605432.htm.
    \2\ https://www.fda.gov/TobaccoProducts/PublicHealthEducation/ProtectingKidsfromTobacco/ucm608433.htm.
    \3\ https://www.fda.gov/tobaccoproducts/publichealtheducation/publiceducationcampaigns/therealcostcampaign/default.htm.
    \4\ https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620788.htm.
---------------------------------------------------------------------------

    In addition to the prevention of initiation, which will be the
cornerstone of any successful effort to curb youth tobacco use, FDA is
also exploring additional approaches to address this issue. On January
18, 2019, FDA held an open public hearing entitled ``Eliminating Youth
Electronic Cigarette and Other Tobacco Product Use: The Role for Drug
Therapies,'' \5\ which requested information on the potential role of
drug therapies to support cessation and the issues impacting the
development of such therapies for youth. FDA appreciates that youth
have unique challenges when it comes to addiction and cessation, and
that they may respond differently to treatments as compared to adults.
---------------------------------------------------------------------------

    \5\ https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm620744.htm
---------------------------------------------------------------------------

    The challenge of developing evidence in pediatric populations
exists in many therapeutic areas. FDA is committed to addressing this
issue. Therefore, FDA has issued grants to the Institute for Advanced
Clinical Trials for Children (I-ACT for Children) and the Duke Clinical
Research Institute (DCRI) to establish a Global Pediatric Clinical
Trials Network to facilitate clinical trials of new drugs and devices
for children. As a part of this work, I-ACT for Children and DCRI are
hosting this public scientific workshop, in collaboration with FDA, to
facilitate the development of evidence to support youth tobacco
cessation efforts, and will result in a written report. This scientific
workshop intends to explore many of the scientific issues brought up
during the recent public hearing on this topic.

II. Topics for Discussion at the Public Scientific Workshop

    This public scientific workshop will gather scientific information
and stimulate discussion about the current science regarding youth
tobacco use and addiction, and treatment strategies to support youth
tobacco cessation with a focus on e-cigarette cessation. This is
because e-cigarettes are the tobacco products most commonly used by
youth (Ref. 5) and there continues to be a rampant rise in use.
According to data from the FDA/CDC 2018 National Youth Tobacco Survey,
more than 3.6 million middle and high school students were current e-
cigarettes users in 2018, representing a substantial increase of more
than 1.5 million students in one year (Ref. 3). Furthermore, data
recently published in JAMA Network Open showed that youth e-cigarette
users are more likely to transition to conventional cigarettes, as
compared to non-users (Ref. 6). The workshop is intended to explore the
challenges of treating youth tobacco addiction and promoting cessation.
In particular, the workshop will highlight differences in treatment
strategies needed in youth as opposed to adults. The workshop will
include presentations and panel discussions regarding substantive
scientific information specifically relating to the unique factors
impacting youth tobacco use and addiction and challenges associated
with youth tobacco cessation. Topics to be addressed include (1) the
basic science of tobacco addiction in adolescents, (2) current state of
behavioral and pharmacotherapy cessation strategies in adolescents
(e.g.,

clinical trial experience to date, use of technology and social media,
impact of social factors), and (3) the development of strategies to
generate robust evidence to address youth tobacco cessation (e.g.,
clinical trial design, measures of adolescent addiction, selection of
endpoints, subpopulation and co-morbidity considerations, and patient
recruitment and retention). Presenters may include, but are not limited
to, staff from FDA's Center for Tobacco Products, FDA's Center for Drug
Evaluation and Research, industry, and academia. There will be
opportunities for the audience to ask questions during this workshop.

III. Participating in the Public Scientific Workshop

    Registration: To register for the public scientific workshop,
please visit the following website by May 13, 2019: https://youth-tobacco-cessation.eventbrite.com. Please provide complete contact
information for each attendee, including name, affiliation, and email
address.
    Registration is free and based on space availability. Persons
interested in attending this workshop must register by May 13, 2019, 5
p.m. Eastern Time. Early registration is recommended because seating is
limited; therefore, FDA may limit the number of participants from each
organization. Registrants will receive confirmation when they have been
accepted. You may choose not to register, however seating is limited,
and space will be available on a first-come, first-served basis.
    If you need special accommodations because of a disability, please
contact Allison Hoffman (see FOR FURTHER INFORMATION CONTACT) no later
than May 8, 2019.
    Persons attending FDA's meetings are advised that the Agency is not
responsible for providing access to electrical outlets.
    Streaming Webcast of the Public Scientific Workshop: This public
scientific workshop will also be webcast. To register for the streaming
webcast of the workshop, please visit the following website by May 13,
2019: https://youth-tobacco-cessation.eventbrite.com.
    If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the website addresses in this document, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.

IV. References

    The following references are on display in the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.

1. U.S. Department of Health and Human Services (2014). ``The Health
Consequences of Smoking--50 Years of Progress: A Report of the
Surgeon General, 2014.'' Atlanta, GA: U.S. Department of Health and
Human Services, Centers for Disease Control and Prevention, National
Center for Chronic Disease Prevention and Health Promotion, Office
on Smoking and Health. (Available at: https://www.surgeongeneral.gov/library/reports/50-years-of-progress/index.html.)
2. Cullen, K.A., B.K. Ambrose, A.S. Gentzke, et al. (2018). ``Notes
from the Field: Use of Electronic Cigarettes and Any Tobacco Product
Among Middle and High School Students--United States, 2011-2018.''
MMWR Morbidity and Mortality Weekly Report, 67:1276-1277. DOI:
http://dx.doi.org/10.15585/mmwr.mm6745a5. (Available at: https://www.cdc.gov/mmwr/volumes/67/wr/mm6745a5.htm.)
3. Gentzke, A.S., M. Creamer, K.A. Cullen, et al. (2019). ``Vital
Signs: Tobacco Product Use Among Middle and High School Students--
United States, 2011-2018.'' MMWR Morbidity and Mortality Weekly
Report, 68:157-164. DOI: http://dx.doi.org/10.15585/mmwr.mm6806e1.
(Available at: https://www.cdc.gov/mmwr/volumes/68/wr/mm6806e1.htm.)
4. U.S. Department of Health and Human Services (2016). ``E-
Cigarette Use Among Youth and Young Adults: A Report of the Surgeon
General.'' Atlanta, GA: U.S. Department of Health and Human
Services, Centers for Disease Control and Prevention, National
Center for Chronic Disease Prevention and Health Promotion, Office
on Smoking and Health. (Available at: https://e-cigarettes.surgeongeneral.gov/documents/2016_sgr_full_report_non-508.pdf.)
5. Wang, T.W., A. Gentzke, S. Sharapova, et al. (2018). ``Tobacco
Product Use Among Middle and High School Students--United States,
2011-2017.'' Morbidity and Mortality Weekly Report (MMWR) 67:629-
633. DOI: https://doi.org/10.15585/mmwr.mm6722a3 (Available at
https://www.cdc.gov/mmwr/volumes/67/wr/mm6722a3.htm).
6. Berry, K.M., J.L. Fetterman, E.J. Benjamin, et al. (2019).
``Association of Electronic Cigarette Use With Subsequent Initiation
of Tobacco Cigarettes in US Youths.'' JAMA Netw Open 2(2):e187794.
DOI: https://doi.org/10.1001/jamanetworkopen.2018.7794 (Available at
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2723425.)

    Dated: March 27, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06323 Filed 4-1-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 123 (Thursday, June 26, 2014)]
[Rules and Regulations]
[Pages 36199-36203]
[FR Doc No: 2014-14935]

=======================================================================
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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 744

[Docket No. 140522446-4446-01]
RIN 0694-AG19

Addition of Certain Persons to the Entity List; and Removal of
Person From the Entity List Based on Removal Request

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Final rule.

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SUMMARY: This rule amends the Export Administration Regulations (EAR)
by adding four persons under five entries to the Entity List. The
persons who are added to the Entity List have been determined by the
U.S. Government to be acting contrary to the national security or
foreign policy interests of the United States. These persons will be
listed on the Entity List under the destinations of China and Hong
Kong. There are five entries for four persons because one person is
listed under multiple countries, resulting in one additional entry.
Specifically, the one additional entry covers one person in China who
also has an address in Hong Kong.
    In addition, this rule removes one person from the Entity List, as
the result of a request for removal submitted by the person, a review
of information provided in the removal request in accordance with the
EAR, and further review conducted by the End-User Review Committee
(ERC).

DATES: Effective Date: This rule is effective June 26, 2014.

FOR FURTHER INFORMATION CONTACT: Karen Nies-Vogel, Chair, End-User
Review Committee, Office of the Assistant Secretary, Export
Administration, Bureau of Industry and Security, Department of
Commerce, Phone:<PHONE_NUMBER>, Fax:<PHONE_NUMBER>, Email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The Entity List (Supplement No. 4 to Part 744) notifies the public
about entities that have engaged in activities that could result in an
increased risk of the diversion of exported, reexported or transferred
(in-country) items to weapons of mass destruction (WMD) programs. Since
its initial publication, grounds for inclusion on the Entity List have
expanded to include activities sanctioned by the State Department and
activities contrary to U.S. national security or foreign policy
interests, including terrorism and export control violations involving
abuse of human rights. Certain exports, reexports, and transfers (in-
country) to entities identified on the Entity List require licenses
from BIS and are usually subject to a policy of denial. The
availability of license exceptions in such transactions is very
limited. The license review policy for each entity is identified in the
license review policy column on the Entity List and the availability of
license exceptions is noted in the Federal Register notices adding
persons to the Entity List. BIS places entities on the Entity List
based on certain sections of part 744 (Control Policy: End-User and
End-Use Based) of the EAR.
    The End-user Review Committee (ERC), composed of representatives of
the Departments of Commerce (Chair), State, Defense, Energy and, where
appropriate, the Treasury, makes all decisions regarding additions to,
removals from, or other modifications to the Entity List. The ERC makes
all decisions to add an entry to the Entity List by majority vote and
all decisions to remove or modify an entry by unanimous vote.

ERC Entity List Decisions

Additions to the Entity List

    This rule implements the decision of the ERC to add four persons
under five entries to the Entity List on the basis of Sec.  744.11
(License requirements that apply to entities acting contrary to the
national security or foreign policy interests of the United States) of
the EAR. The five entries added to the Entity List consist of four
entries in China, and one entry in Hong Kong.
    The ERC reviewed Sec.  744.11(b) (Criteria for revising the Entity
List) in making the determination to add these four persons to the
Entity List. Under that paragraph, persons for whom there is reasonable
cause to believe, based on specific and articulable facts, have been
involved, are involved, or pose a significant risk of being or becoming
involved in, activities that are contrary to the national security or
foreign policy interests of the United States and those acting on
behalf of such persons may be added to the Entity List. Paragraphs
(b)(1) through (b)(5) of Sec.  744.11 include an illustrative list of
activities that could be contrary to the national security or foreign
policy interests of the United States.
    The four persons being added have been determined by the ERC to be
involved in activities that are contrary to the national security or
foreign policy interests of the United States, including the activities
described under paragraph (b)(2) and (b)(5) of Sec.  744.11.
    The ERC determined that Poly Technologies Inc., Xinshidai Company
(New Era Group), and Panda International Information Technology
Company, all located in China, and HWA Create, located in China and
Hong Kong, be added to the Entity List on the basis of their attempts
to procure items, including U.S.-origin items, for activities contrary
to the national security and foreign policy interests of the United
States. The ERC determined that these persons' activities have included
the activities described under paragraph (b)(2) and (b)(5) of Sec.
744.11 of the EAR. Specifically, these companies have attempted to
supply items to the People's Liberation Army and/or to export items to
destinations sanctioned by the United States. The Department of State
sanctioned Poly Technologies Inc. under the Iran, North Korea and Syria
Nonproliferation Act (INKSNA) in February 2013. Xinshidai Company was
sanctioned in 2004 by the Departments of State and the Treasury under
Executive Order 12938, and again by the State Department under INKSNA
in 2008.
    Pursuant to Sec.  744.11(b)(2) and (b)(5) of the EAR, the ERC
determined that the conduct of these four persons raises sufficient
concern that prior review of exports, reexports, or transfers (in-
country) of items subject to the EAR involving these persons, and the
possible imposition of license conditions or license denials on
shipments to the persons, will enhance BIS's ability to prevent
violations of the EAR.
    For the four persons recommended for addition, the ERC specified a
license requirement for all items subject to the EAR and a license
review policy of presumption of denial. The license requirements apply
to any transaction in which items are to be exported, reexported, or
transferred (in-country) to any of the persons or in which such persons
act as purchaser, intermediate consignee, ultimate consignee, or end-
user. In addition, no license exceptions are available for exports,
reexports, or transfers (in-country) to the persons being added to the
Entity List in this rule.
    This final rule adds the following four persons under five entries
to the Entity List:

China

    (1) China Xinshidai Company, a.k.a., the following one alias:
    --China New Era Group, Xinshidai Plaza, Plaza No. 7 Huayuan Rd.,
Beijing, China;
    (2) HWA Create, 5/F, Xinshidai Building/New Era Mansion, 7 Huayuan
Rd., Beijing, China; and
    No. B3 Huayuan Rd., Beijing, China (See alternate addresses under
Hong Kong);
    (3) Panda International Information Technology Company, Ltd., 7/F,
B Tower, Yingwu Conference Center, No. 6. Huayuan Road, Haidian
District, Beijing, China; and
    Rm 606 Block B, Beijing Agricultural Science Building, Shugang
Garden Haidian Middle Rd, Beijing, China; and

    (4) Poly Technologies Inc., 11F Poly Plaza, 14 Dongzhimen Nandajie,
Beijing China; and
    27 Wanshoulu, Haidian district, Beijing, China.

Hong Kong

    (1) HWA Create, Unit 1001-1002, 10F, Chinachem Building, 34-37
Connaught Rd., Hong Kong; and
    Unit A 5th Floor, Cheong Commercial Building, 19-25 Jervois St,
Hong Kong; and
    Unit B, 6/F, Dah Sing Life Building, 99--1-5 Des Voeux Rd, Hong
Kong (See alternate addresses under China).

Removal From the Entity List

    This rule implements a decision of the ERC to remove one person,
Masoud Est. for Medical and Scientific Supplies, located in Jordan,
from the Entity List as a result of the person's request for removal
from the Entity List. Based upon the review of the information provided
in the removal request in accordance with Sec.  744.16 (Procedure for
requesting removal or modification of an Entity List entity), and after
review by the ERC's member agencies, the ERC determined that this
person should be removed from the Entity List.
    The ERC decision to remove this person took into account this
person's cooperation with the U.S. Government during the appeal
process. In accordance with Sec.  744.16(c), the Deputy Assistant
Secretary for Export Administration has sent written notification to
this person, informing this entity of the ERC's decision to remove it
from the Entity List. This final rule implements the decision to remove
the following person located in Jordan from the Entity List:

Jordan

    (1) Masoud Est. for Medical and Scientific Supplies, 74 First
Floor, Tla'a Al Ali Khali Al Salim Street, Amman, Jordan 11118.
    The removal of the one entity referenced above, which was made on
the basis of a Sec.  744.16 removal request and was approved by the
ERC, eliminates the existing license requirements in Supplement No. 4
to part 744 for exports, reexports and transfers (in-country) to the
entity. However, the removal of this entity from the Entity List does
not relieve persons of other obligations under part 744 of the EAR or
under other parts of the EAR. Neither the removal of an entity from the
Entity List nor the removal of Entity List-based license requirements
relieves persons of their obligations under General Prohibition 5 in
Sec.  736.2(b)(5) of the EAR which provides that, ``you may not,
without a license, knowingly export or reexport any item subject to the
EAR to an end-user or end-use that is prohibited by part 744 of the
EAR.'' Additionally this removal does not relieve persons of their
obligation to apply for export, reexport or in-country transfer
licenses required by other provisions of the EAR. BIS strongly urges
the use of Supplement No. 3 to part 732 of the EAR, ``BIS's `Know Your
Customer' Guidance and Red Flags,'' when persons are involved in
transactions that are subject to the EAR.

Savings Clause

    Shipments of items removed from eligibility for a License Exception
or export or reexport without a license (NLR) as a result of this
regulatory action that were en route aboard a carrier to a port of
export or reexport, on June 26, 2014, pursuant to actual orders for
export or reexport to a foreign destination, may proceed to that
destination under the previous eligibility for a License Exception or
export or reexport without a license (NLR).

Export Administration Act

    Although the Export Administration Act expired on August 20, 2001,
the President, through Executive Order 13222 of August 17, 2001, 3 CFR,
2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March
8, 2013, 78 FR 16129 (March 13, 2013) and as extended by the Notice of
August 8, 2013, 78, 2013, 78 FR 49107(August 12, 2013), has continued
the Export Administration Regulations in effect under the International
Emergency Economic Powers Act. BIS continues to carry out the
provisions of the Export Administration Act, as appropriate and to the
extent permitted by law, pursuant to Executive Order 13222 as amended
by Executive Order 13637.

Rulemaking Requirements

    1. Executive Orders 13563 and 12866 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This rule has been determined to be not significant for
purposes of Executive Order 12866.
    2. Notwithstanding any other provision of law, no person is
required to respond to nor be subject to a penalty for failure to
comply with a collection of information, subject to the requirements of
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA),
unless that collection of information displays a currently valid Office
of Management and Budget (OMB) Control Number. This regulation involves
collections previously approved by OMB under control number 0694-0088,
Simplified Network Application Processing System, which includes, among
other things, license applications and carries a burden estimate of
43.8 minutes for a manual or electronic submission. Total burden hours
associated with the PRA and OMB control number 0694-0088 are not
expected to increase as a result of this rule. You may send comments
regarding the collection of information associated with this rule,
including suggestions for reducing the burden, to Jasmeet K. Seehra,
Office of Management and Budget (OMB), by email to<EMAIL_ADDRESS>or by fax to<PHONE_NUMBER>.
    3. This rule does not contain policies with Federalism implications
as that term is defined in Executive Order 13132.
    4. For the four persons added under five entries to the Entity List
in this final rule, the provisions of the Administrative Procedure Act
(5 U.S.C. 553) requiring notice of proposed rulemaking, the opportunity
for public comment and a delay in effective date are inapplicable
because this regulation involves a military or foreign affairs function
of the United States. (See 5 U.S.C. 553(a)(1)). BIS implements this
rule to protect U.S. national security or foreign policy interests by
preventing items from being exported, reexported, or transferred (in
country) to the persons being added to the Entity List. If this rule
were delayed to allow for notice and comment and a delay in effective
date, then entities being added to the Entity List by this action would
continue to be able to receive items without a license and to conduct
activities contrary to the national security or foreign policy
interests of the United States. In addition, because these parties may
receive notice of the U.S. Government's intention to place these
entities on the Entity List if a proposed rule is published, doing so
would create an incentive for these persons to either accelerate
receiving items subject to the EAR to conduct activities that are
contrary to the national security or foreign policy interests of the
United States, or to take steps to set up

additional aliases, change addresses, and other measures to try to
limit the impact of the listing on the Entity List once a final rule
was published. Further, no other law requires that a notice of proposed
rulemaking and an opportunity for public comment be given for this
rule. Because a notice of proposed rulemaking and an opportunity for
public comment are not required to be given for this rule by 5 U.S.C.
553, or by any other law, the analytical requirements of the Regulatory
Flexibility Act, 5 U.S.C. 601 et seq., are not applicable. Accordingly,
no regulatory flexibility analysis is required and none has been
prepared.
    5. For the one removal from the Entity List in this final rule,
pursuant to the Administrative Procedure Act (APA), 5 U.S.C.
553(b)(3)(B), BIS finds good cause to waive requirements that this rule
be subject to notice and the opportunity for public comment because it
would be contrary to the public interest.
    In determining whether to grant removal requests from the Entity
List, a committee of U.S. Government agencies (the End-user Review
Committee (ERC)) evaluates information about and commitments made by
listed persons requesting removal from the Entity List, the nature and
terms of which are set forth in 15 CFR part 744, Supplement No. 5, as
noted in 15 CFR 744.16(b). The information, commitments, and criteria
for this extensive review were all established through the notice of
proposed rulemaking and public comment process (72 FR 31005 (June 5,
2007) (proposed rule), and 73 FR 49311 (August 21, 2008) (final rule)).
This removal has been made within the established regulatory framework
of the Entity List. If the rule were to be delayed to allow for public
comment, U.S. exporters may face unnecessary economic losses as they
turn away potential sales because the customer remained a listed person
on the Entity List even after the ERC approved the removal pursuant to
the rule published at 73 FR 49311 on August 21, 2008. By publishing
without prior notice and comment, BIS allows the applicant to receive
U.S. exports immediately since the applicant already has received
approval by the ERC pursuant to 15 CFR part 744, Supplement No. 5, as
noted in 15 CFR 744.16(b).
    The removals from the Entity List granted by the ERC involve
interagency deliberation and result from review of public and non-
public sources, including sensitive law enforcement information and
classified information, and the measurement of such information against
the Entity List removal criteria. This information is extensively
reviewed according to the criteria for evaluating removal requests from
the Entity List, as set out in 15 CFR part 744, Supplement No. 5 and 15
CFR 744.16(b). For reasons of national security, BIS is not at liberty
to provide to the public the information on which the ERC relied to
make the decision to remove this entity. In addition, the information
included in the removal request is specific to information exchanged
between the applicant and the ERC, which by law (section 12(c) of the
Export Administration Act), BIS is restricted from sharing with the
public. The removal requests from the Entity List contain confidential
business information, which is necessary for the extensive review
conducted by the U.S. Government in assessing such removal requests.
    Section 553(d) of the APA generally provides that rules may not
take effect earlier than thirty (30) days after they are published in
the Federal Register. BIS finds good cause to waive the 30-day delay in
effectiveness under 5 U.S.C. 553(d)(1) because this rule is a
substantive rule which relieves a restriction. This rule removes a
requirement (the Entity-List-based license requirement and limitation
on use of license exceptions) on this one person being removed from the
Entity List. The rule does not impose a requirement on any other person
for this one removal from the Entity List.
    No other law requires that a notice of proposed rulemaking and an
opportunity for public comment be given for this final rule. Because a
notice of proposed rulemaking and an opportunity for public comment are
not required under the APA or by any other law, the analytical
requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.)
are not applicable. As a result, no final regulatory flexibility
analysis is required and none has been prepared.

List of Subject in 15 CFR Part 744

    Exports, Reporting and recordkeeping requirements, Terrorism.

    Accordingly, part 744 of the Export Administration Regulations (15
CFR parts 730-774) is amended as follows:

PART 744--[AMENDED]

0
1. The authority citation for 15 CFR part 744 continues to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22
U.S.C. 7210; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179;
E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59
FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 12947, 60 FR 5079, 3 CFR,
1995 Comp., p. 356; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p.
228; E.O. 13099, 63 FR 45167, 3 CFR, 1998 Comp., p. 208; E.O. 13222,
66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13224, 66 FR 49079, 3
CFR, 2001 Comp., p. 786; Notice of August 8, 2013, 78 FR 49107
(August 12, 2013); Notice of September 18, 2013, 78 FR 58151
(September 20, 2013); Notice of November 7, 2013, 78 FR 67289
(November 12, 2013); Notice of January 21, 2014, 79 FR 3721 (January
22, 2014).

0
2. Supplement No. 4 to part 744 is amended:
0
a. By adding under China, in alphabetical order, four Chinese entities;
and
0
b. By adding under Hong Kong, in alphabetical order, one Hong Kong
entity.
0
c. By removing the heading ``Jordan,'' and one Jordanian entity,
``Masoud Est. for Medical and Scientific Supplies, 74 First Floor,
Tla'a Al Ali Khali Al Salim Street, Amman, Jordan 11118.''
    The additions read as follows:

Supplement No. 4 to Part 744--Entity List

--------------------------------------------------------------------------------------------------------------------------------------------------------
              Country                           Entity                License requirement     License review policy       Federal Register citation
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
CHINA, PEOPLE'S REPUBLIC OF

                                                                      * * * * * * *
                                     China Xinshidai Company,     For all items subject to    Presumption of denial  79 FR [INSERT FR PAGE NUMBER 6-26-
                                      a.k.a., the following one    the EAR. (See Sec.                                 14].
                                      alias: -China New Era        744.11 of the EAR).
                                      Group.

                                     Xinshidai Plaza, Plaza No.
                                      7 Huayuan Rd., Beijing,
                                      China.

                                                                      * * * * * * *
                                     HWA Create, 5/F, Xinshidai   For all items subject to    Presumption of denial  79 FR [INSERT FR PAGE NUMBER 6-26-
                                      Building/New Era Mansion,    the EAR. (See Sec.                                 14].
                                      7 Huayuan Rd., Beijing,      744.11 of the EAR).
                                      China; and No. B3 Huayuan
                                      Rd., Beijing, China (See
                                      alternate addresses under
                                      Hong Kong).

                                                                      * * * * * * *
                                     Panda International          For all items subject to    Presumption of denial  79 FR [INSERT FR PAGE NUMBER 6-26-
                                      Information Technology       the EAR. (See Sec.                                 14].
                                      Company, Ltd., 7/F, B        744.11 of the EAR).
                                      Tower, Yingwu Conference
                                      Center, No. 6. Huayuan
                                      Road, Haidian District,
                                      Beijing, China; and Rm 606
                                      Block B, Beijing
                                      Agricultural Science
                                      Building, Shugang Garden
                                      Haidian Middle Rd,
                                      Beijing, China.
                                     Poly Technologies Inc., 11F  For all items subject to    Presumption of denial  79 FR [INSERT FR PAGE NUMBER 6-26-
                                      Poly Plaza, 14 Dongzhimen    the EAR. (See Sec.                                 14].
                                      Nandajie, Beijing China;     744.11 of the EAR).
                                      and 27 Wanshoulu, Haidian
                                      district, Beijing, China.

                                                                      * * * * * * *
HONG KONG

                                                                      * * * * * * *
                                     HWA Create, Unit 1001--      For all items subject to    Presumption of denial  79 FR [INSERT FR PAGE NUMBER 6-26-
                                      1002, 10F, Chinachem         the EAR. (See Sec.                                 14].
                                      Building, 34-37 Connaught    744.11 of the EAR).
                                      Rd., Hong Kong; and Unit A
                                      5th Floor, Cheong
                                      Commercial Building, 19-25
                                      Jervois St, Hong Kong; and
                                      Unit B, 6/F, Dah Sing Life
                                      Building, 99--1-5 Des
                                      Voeux Rd, Hong Kong (See
                                      alternate addresses under
                                      China).

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Dated: June 20, 2014.
Kevin J. Wolf,
Assistant Secretary for Export Administration.
[FR Doc. 2014-14935 Filed 6-25-14; 8:45 am]
BILLING CODE 3510-33-P


[Federal Register Volume 82, Number 29 (Tuesday, February 14, 2017)]
[Notices]
[Page 10569]
[FR Doc No: 2017-02947]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL17-45-000]

California Public Utilities Commission; Northern California Power
Agency; State Water Contractors; Transmission Agency of Northern
California v. Pacific Gas and Electric Company; Notice of Complaint

    Take notice that on February 2, 2017, pursuant to sections 206 and
306 of the Federal Power Act \1\ and Rules 206 and 212 of the Federal
Energy Regulatory Commission's (Commission) Rules of Practice and
Procedure,\2\ California Public Utilities Commission, Northern
California Power Agency, State Water Contractors and Transmission
Agency of Northern California (collectively, the Complainants), filed a
formal complaint against Pacific Gas and Electric Company (PG&E or
Respondent) alleging that PG&E has violated its obligation under Order
No. 890 to conduct an open, coordinated, and transparent transmission
planning process by approving more than 80 percent of its transmission
projects on an entirely internal basis, as more fully explained in the
complaint.
---------------------------------------------------------------------------

    \1\ 16 U.S.C. 824e and 825e.
    \2\ 18 CFR 385.206 and 385.212.
---------------------------------------------------------------------------

    Complainants certify that copies of the Complaint were served on
contacts for Pacific Gas and Electric Company as listed on the
Commission's list of Corporate Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
``eSubscription'' link on the Web site that enables subscribers to
receive email notification when a document is added to a subscribed
docket(s). For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on February 22, 2017.

    Dated: February 3, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-02947 Filed 2-13-17; 8:45 am]
 BILLING CODE 6717-01-P