                     U. S. ENVIRONMENTAL PROTECTION AGENCY
                            Washington, D.C. 20460

                                   OFFICE OF
                              CHEMICAL SAFETY AND
       POLLUTION PREVENTION

                                                     PC Code: 071503
                                              DP Barcode: D395364, D389616
                                                     Date: October 27, 2011

MEMORANDUM

SUBJECT:	Tier I Drinking Water Assessment in Support of Proposed or Amended Tolerances for the Fludioxonil IR-4 Uses on Ginseng; Onion Subgroups 3-07 A and B; Berry and Small Fruit Subgroups 13-07 A, B, F and G; Fruiting Vegetable Group 8-10, Except Tomato; Tomato; Leafy Vegetable Except Brassica Subgroup 4A; Pome Fruit Group 11-10; Citrus Group 10-10; Potato; Pineapple; Dragon Fruit; Avocado; Mango; Other Various Tropical Fruits.

TO:		George Kramer, Chemist
      Dana Vogel, Branch Chief
		Risk Assessment Branch 1
		Health Effects Division (7505P)

cc:		Barbara Madden, Team Leader
		Lisa Nollen, Risk Manager Reviewer
		Risk Integration Minor Use, and Emergency Response Branch
		Registration Division (7505P)

      Shaja Joyner, Product Manager
		Lisa Jones, Risk Manager Reviewer
		Fungicide Branch
		Registration Division (7505P)

FROM:	Cheryl Sutton, Ph.D., Environmental Scientist
		Environmental Risk Branch IV
		Environmental Fate and Effects Division (7507P)

REVIEWED
BY:		Charles Peck, Environmental Engineer
      Environmental Risk Branch IV
		Environmental Fate and Effects Division (7507P)
 APPROVED
BY:		Marietta Echeverria, Branch Chief
		Environmental Risk Branch IV
		Environmental Fate and Effects Division (7507P)

Executive Summary

EFED has completed a Tier I screening-level drinking water assessment for fludioxonil for the proposed IR-4 uses on ginseng; onion subgroups 3-07 a and b; berry and small fruit subgroups 13-07 a, b, f and g; fruiting vegetable group 8-10, except tomato; tomato; leafy vegetable except brassica subgroup 4a; pome fruit group 11-10; citrus group 10-10; potato; pineapple; dragon fruit; avocado; mango; and other various tropical fruits.  This assessment is in support of proposed or amended tolerances for the crops/crop groups listed above.
Fludioxonil (CAS 131341-86-1), a fungicide, is an active ingredient contained in multiple end-use products including, among others, Switch(R) 62.5 WG (25% a.i., with 37.5% cyprodinil; EPA Reg. No. 100-953); Cannonball(R) WP (50% a.i.; EPA Reg. 100-1360); Scholar(R) Fungicide (50% a.i.; post-harvest usage only; EPA Reg. 100-969); Scholar(R) SC Fungicide (20.4% a.i.; post-harvest usage only; EPA Reg. 100-1242);  and Graduate A+ (TM) (20.6% a.i., with 20.6% azoxystrobin; post-harvest usage only; EPA Reg. 100-1308).  Similar to previous assessments, this evaluation is limited to the exposure associated with fludioxonil alone and does not include exposure associated with fludioxonil in combination with cyprodinil or azoxystrobin.
The maximum proposed application rate among all proposed uses listed above (for onion subgroups 3-07 a and b grown for seed) is 0.25 lbs ai/A/application, applied four times per year with a 7-day application interval, for a maximum total annual application rate of 1.0 lb ai/A/yr.  Because the maximum proposed application rate among all of the uses considered for this assessment is less than the rates previously assessed by EFED for ornamentals, the estimated drinking water concentrations (EDWC) based on use on ornamentals are recommended for use in the human health dietary assessment and are presented in Table 1.
The most recent Tier II drinking water assessment (DWA memo dated 8/27/2009; DP Barcode 368586) evaluated fludioxonil applications to container-grown ornamentals, and reported acute, chronic, and long-term (cancer) EDWCs of 108 ppb, 32.6 ppb (incorrectly reported as 53 ppb in the main text, but accurately presented in the modeling output in Appendix A of that document), and 25.5 ppb, respectively; and a groundwater concentration of 0.4 ppb.  The maximum application rate used in that assessment was one application of 4 lb ai/A/yr.  [EFED notes that the Tier II assessment was a refinement of a Revised Tier I assessment (8/20/2009; DP364264) that was also conducted using an application rate of 4 lb ai/A/yr on container-grown ornamentals.  The initial Tier I assessment of 6/22/2009 (same DP barcode) was conducted using an application rate of 2 lb ai/A/yr, only on field-grown ornamentals.]

However, based on information provided in Syngenta's 9/9/2011 submission "Fludioxonil Registration Review Public Comments Response to Initial 60-Day Comment Period, Case Number: 7017, Docket Number: EPA-HQ-OPP-2010-1067," EFED concurs that the use of the container-grown ornamentals application rate is not appropriate for estimating EDWCs.  As noted by the registrant, the strong adsorption of the pesticide to the potting media used for container-grown ornamentals, as well as the use of containers, results in attenuation of pesticide movement from the containers to the underlying soil in the field, thereby reducing potential runoff of the pesticide.  Thus, EFED now recommends that the values from the Tier I DWA of 6/22/2009 (D364264) be used in HED's human dietary health assessment.  The values in the Tier I DWA are based on the use of fludioxonil on field-grown ornamentals at one application of 2 lb ai/A/yr.
The maximum proposed application rates for all of the uses considered for this assessment are presented in detail Table 2 in the Use Characterization section of this document.

Table 1.  Maximum Tier I Estimated Drinking Water Concentrations in surface water based on fludioxonil use on field grown ornamentals at 2 lb ai/A/yr.
                      Drinking Water Source (Model Used)
                              USE (Rate Modeled)
        Maximum Estimated Drinking Water Concentration  (EDWC)  (μg/L)
Groundwater (SCIGROW)
Field grown ornamentals (2 lbs. a.i./A/applic. x 1 applic.; total rate of 2 lb ai/A/yr )
Acute and Chronic
                                     0.20
Surface Water  (FIRST)
Field grown ornamentals (2 lbs. a.i./A/applic. x 1 applic.; total rate of 2 lb ai/A/yr )
Acute
                                     83.8

Field grown ornamentals (2 lbs. a.i./A/applic. x 1 applic.; total rate of 2 lb ai/A/yr )
Chronic
                                           38.5

Use Characterization

Fludioxonil is a phenylpyrole derivative of an antibiotic produced by the soil-borne bacterium Pseudomonas. It is intended to control certain post-harvest diseases caused by Monilinia fructicola and M. laxa (brown rot), Botrytis cinerea (gray mold), and Rhizopus stolonifer (Rhizopus rot). A suggested mode of action of phenylpyrroles derivatives is inhibition of the trans-membrane transport associated with glucose phosphorylation (USEPA, 1998).

Maximum use pattern information for the proposed IR-4 uses being assessed here is presented in Table 2.

Table 2. Summary use information for proposed IR-4 uses of fludioxonil on various crops.
                                      Use
                         Max. Single Application Rate
                                 (lbs. a.i./A)
                              No. of Applications
                           Annual Application Rate
                               (lbs. a.i./A/yr)
                      Minimum Application Interval (days)
                             Application Method(s)
ginseng
                                    0.25[2]
                                       4
                                      1.0
                                      14
                         Drip irrigation or drenching
onion subgroups 3-07 a and b
                                    1.0[2]
                                       1
                                      1.0
                 Not Applicable (at-planting ground treatment)
                          Ground spray (soil applied)
onion subgroups 3-07 a and b grown for seed
                                    0.25[2]
                                       4
                                      1.0
                                       7
                            Ground spray (foliar)
berry and small fruit subgroups 13-07 a, b, f and g
                                    0.22[1]
                                       4
                                      0.9
                                       7
                                 Ground spray
                            Aerial spray in CA only
fruiting vegetable group 8-10, except tomato
                                    0.22[1]
                                       4
                                      0.9
                                       7
                                 Ground spray
tomato
                                    0.22[1]
                                       4
                                      0.9
                                       7
                                 Ground spray
leafy vegetable except brassica subgroup 4a
                                    0.22[1]
                                       4
                                      0.9
                                       7
                                 Ground spray
pome fruit group 11-10
                          Post-harvest usage only.[3]
citrus group 10-10

potato

pineapple

dragon fruit
                                    0.22[1]
                                       4
                                      0.9
                                       7
                                 Ground spray
                            Aerial spray in CA only
avocado
                                    0.22[1]
                                       4
                                      0.9
                                       7
                                 Ground spray
                            Aerial spray in CA only
mango
                                    0.22[1]
                                       4
                                      0.9
                                       7
                                 Ground spray
                            Aerial spray in CA only
various tropical fruits
                                    0.22[1]
                                       4
                                      0.9
                                       7
                                 Ground spray
                            Aerial spray in CA only
[1]Application information obtained from the label for Switch(R) 62.5 WG (25% a.i., with 37.5% cyprodinil; EPA Reg. No. 100-953).  Maximum number of applic. per year assumed (4) based on maximum single and annual rates.  [2]Application information obtained from the label for Cannonball(R) WP (50% a.i.; EPA Reg. 100-1360).  Maximum number of applic. per year assumed (4) based on maximum single and annual rates for crops receiving more than one application per year. [3]Application information obtained from the labels for Scholar(R) Fungicide (50% a.i.; post-harvest usage only; EPA Reg. 100-969); Scholar(R) SC Fungicide (20.4% a.i.; post-harvest usage only; EPA Reg. 100-1242);  and Graduate A+ (TM) (20.6% a.i., with 20.6% azoxystrobin; post-harvest usage only; EPA Reg. 100-1308).

Environmental Fate and Transport Characterization

Laboratory and field data suggest that fludioxonil is moderately persistent to persistent (Goring et. al. 1975 persistence scale) in soil, with laboratory soil metabolism half-lives ranging from 143 to 365 days, and field dissipation half-lives ranging from 87 to 228 days.  Fludioxonil is expected to be essentially stable in aquatic environments, based on laboratory half-lives of 473-718 days in aerobic aquatic metabolism studies and the results of anaerobic (flooded) soil studies in which the compound was stable.  Photolysis is a major route of degradation, with a (near-surface) soil half-life of 1.6 days and an aqueous (near-surface) half-life of 8.7 days. Fludioxonil is slightly to moderately mobile (FAO classification scheme) in soil (Koc = 991 - 2440 mL/goc) and is primarily a concern for surface waters.  Degradates of fludioxonil are highly mobile; however, none of the four major degradates are considered to be of toxicological concern.   The fludioxonil physical and chemical properties and the environmental fate source data from submitted studies are presented in Table 3.

There is a potential for fludioxonil to reach surface water through spray drift, as the compound may be applied by ground spray and aerial spray (in CA, limited crops).  Because fludioxonil is moderately persistent to persistent in surface soils, there is also the potential for it to reach surface water through surface runoff either in solution or adsorbed to the soil.  Based on the moderately high adsorption coefficients and the low solubility (1.5 ppm), it is unlikely that there will be significant contamination of surface water with fludioxonil through subsurface flow.

Table 3. Physical/chemical properties and environmental fate source data for fludioxonil.
                                    Property
                                     Value
                                    Source
                                   Comments
 Chemical Name
dinitrophenyl-U-[[14]C]-labeled N-(2-chloro-6-fluorobenzyl)-N-ethyl-α,α,α-trifluoro-2,6-dinitro-p-toluidine
                                       -
 -
Molecular Weight
                                    248.19
Product chemistry
 -
Solubility in Water (20 °C)
                                   1.5 mg/L

Product chemistry
 -
Vapor Pressure (20 °C)
                              5.33 10[-9] torr
Product chemistry
 -
Hydrolysis Half-life (pH 7; 25C)
                                    Stable
MRID 43152502
 -
Aqueous Photolysis Half-life (@ pH 7; in days)
                                     8.7
MRID 43496302
44382308
 -
Soil Photolysis Half-life (days)
                                      1.6
MRID  43496303
44382308
              (corrected for natural sunlight at 40°N latitude)
Aerobic Soil Metabolism Half-life (days)
                    143, 220, 183, 365, 365, 325, 239, 154
 MRIDs 43380513, 47169301, 47169302a, 471693012, 471693013, 471693014
 -
Anaerobic Soil Metabolism Half-life (days)
                                    Stable
MRIDs 47169302b, 47169303
Parent still 85% at 60-d post-flooding.
Parent still 83% at 362-d post-flooding.
Aerobic Aquatic Metabolism Half-life (days)
                        Stable (both sediment systems)
47169304
Parent was still present at 83% and 78% of the applied at the end of the 177-day study.
Anaerobic Aquatic Metabolism Half-life (days)
                                    No Data
                                       -
 -
Organic Carbon-Normalized Soil Partition Coeffic. (mL/goc) (Koc)
                                  991 (loam)
                                  1250 (loam)
                                  1490 (sand)
                               2440 (sandy loam)
MRID 44382311
 -
Terrestrial Field Dissipation
(t (1/2); days )
(top 15 cm of soil)
                                      211
44382316
Bareground plot in NJ; turf plot results not valid.

                                      228
                                   44382314
                                   44382315
44382317
Bareground plot in GA; turf plot results not valid.

                                      87
                                   44940102
45357001
Bareground plot in CA.
Henry's Law Constant
                       1.16 x 10[-][9] atm-m[3]-mole[-1]
 -
 -
Bioconcentration Factor in Fish (BCF)
                                     430X
MRID 44382320
 -

Monitoring Data

Fludioxonil is not included as one of the analytes monitored in U.S. surface and groundwater under the USGS's National Water Quality Assessment (NAWQA) program (http://water.usgs.gov/nawqa), nor were surface water and sediment monitoring data available from the California Department of Pesticide Regulation (CDPR).
 Drinking Water Exposure Modeling

All of the information presented below was obtained from the Tier I DWA of 6/22/2009 (D364264) and is presented again here for HED's convenience.

Models

An EDWC in groundwater was estimated using EFED's Tier I aquatic model SCIGROW (Screening Concentration in Ground Water, version 2.3; 8/8/2003).  SCIGROW is a regression model used as a screening tool to estimate pesticide concentrations found in ground water used as drinking water.  SCIGROW was developed by fitting a linear model to groundwater concentrations with the Relative Index of Leaching Potential (RILP) as the independent variable.  Groundwater concentrations were taken from 90-day average high concentrations from Prospective Ground Water studies; the RILP is a function of aerobic soil metabolism and the soil-water partition coefficient.  The output of SCIGROW represents the concentrations that might be expected in shallow unconfined aquifers under sandy soils, which is representative of the ground water most vulnerable to pesticide contamination likely to serve as a drinking water source (USEPA, 2002)

The EDWCs in surface water were estimated using EFED's Tier I aquatic model FIRST (v1.1.1; 3/26/08).  FIRST (FQPA Index Reservoir Screening Tool) is a metamodel of PRZM and EXAMS used as a screening tool to estimate pesticide concentrations found in surface water used as drinking water.  FIRST was developed by making multiple runs of PRZM using varying sorption coefficients and determining the concentration in the EXAMS index reservoir scenario after a two-inch single storm event.  The Index Reservoir is a standard water body used by the Office of Pesticide Programs to assess drinking water exposure (Jones et al., 1998).  It is based on a real reservoir (albeit not currently in active use as a drinking water supply), Shipman City Lake in Illinois, that is known to be vulnerable to pesticide contamination.  The single runoff event moves a maximum of 8% of the applied pesticide into the reservoir.  This amount can be reduced by degradation or effects of binding to soil in the field.  Additionally, FIRST can account for spray drift and adjusts for the area within a watershed that is planted with the modeled crop (Percent Cropped Area).   Spray drift (modeled as direct deposition of the pesticide into the reservoir) is assumed to be 16% of the applied active ingredient for aerial application, 6.3% for orchard air blast application, and 6.4% for other ground spray application. Despite being a single event model, FIRST can account for spray drift from multiple applications.  The non-agricultural Percent Cropped Area (PCA) of 100% was used in this assessment.  The PRZM scenario used for FIRST development was among the most vulnerable, and thus resulting surface water concentrations represent the upper bound values on the concentrations that might be found in drinking water from the use of a pesticide.

Modeling Approach and Input Parameters

Tier I modeling for the EDWC in surface water and groundwater from fludioxonil use on field-grown ornamentals was conducted using the maximum proposed application rate of 2.0 lbs a.i./A/application applied once for a total application rate of 2 lb ai/A/yr. Physical/chemical properties and environmental fate source data (from submitted studies) were presented in Table 3.  Input values used for surface water modeling with FIRST are presented in Table 4.   Input values used for groundwater modeling with SCI-GROW2 are presented in Table 5.

Input parameter values used in this assessment were selected from the environmental fate data submitted by the registrant and in accordance with US EPA-OPP EFED water model parameter selection guidelines, Guidance for Selecting Input Parameters in Modeling the Environmental Fate and Transport of Pesticides, Version 2.1, October 22, 2009.

Table 4. FIRST input parameter values for fludioxonil use on field-grown ornamentals.
Parameter (Units)
Value(S)
Source
Comment
Application Rate (lb a.i./A)
2.0
Medallion Label
 -
Number of Applications
1
Medallion Label
 -
Interval between Applications (days)
NA
Medallion Label
 -
Percent Cropped Area (decimal)
1.0
Medallion Label
A PCA is not used for ornamentals.
Soil Partition Coefficient
KOC (mL/gOC))
991
MRID 44382311
Represents the lowest non-sand Koc value among four values ranging from 991 to 2440  mL/g.
Aerobic Soil Metabolism Half-life (days)
294.9
MRIDs 43380513, 47169301, 47169302a, 471693012, 471693013, 471693014
Represents the 90[th] percentile of the upper confidence bound on the mean (249.3) of 8 half-life values.
Wetted in?
No
Medallion Label
 -
Depth of Incorporation (inches)
0
Medallion Label
 -
Method of Application
Ground spray
Medallion Label
 -
Solubility in Water @ 20 [O]C, (pH 7; in mg/L or ppm)
1.5
Product Chemistry
 -
Aerobic Aquatic Metabolism Half-life (days)
0 (stable)
MRID 47169304
 -
Hydrolysis Half-life @ pH 7, 25 [O]C (days)
0 (stable)
MRID 43152502
 -
Aquatic Photolysis Half-life  @ pH 7 (days)
8.7
MRID 43496302
 -

Table 5.  SCI-GROW2 input parameter values for fludioxonil use on field-grown ornamentals.
Model Input Parameter
Input Value and Unit[1]
Source
Comments
Aerobic Soil Metabolism Half-life (days)
230
MRIDs   43380513, 47169301, 47169302a, 471693012, 471693013, 471693014
Median of eight values
Organic Carbon Normalized Partition Coefficient  Koc
1370
MRID 44382311
Median of four values
Application Rate
2 lb ai/A/application

Medallion Label
 -
Maximum No. of Applications/Year
1
Medallion Label
 -
[1]Values determined per USEPA 2009a.

Modeling Results

	Tier I surface water and groundwater modeling results for fludioxonil for ground spray application to field-grown ornamentals are presented in Table 6.  These values are recommended for use in the human health risk assessment.  Output values for surface water are not modified using the percentage crop area (PCA) adjustment factor since the value used for field grown ornamentals is 1.0 (USEPA 2010).  Output values for groundwater are not adjusted for a PCA.

Table 6.  Maximum Tier I EDWCs based on ground spray application of fludioxonil to field grown ornamentals at 2 lbs. a.i./A/yr applied in a single application.
Drinking Water Source (Model Used)
Use (Rate Modeled)
Maximum Estimated Drinking Water Concentration  (EDWC)  (μg/L)
                             Groundwater (SCIGROW)
                            Field grown ornamental
                               Acute and Chronic
                                     0.20
                            Surface Water  (FIRST)
                            Field grown ornamental
                                     Acute
                                     83.8

                            Field grown ornamental
                                    Chronic
                                     38.5

The SCIGROW concentration (ppb) represents the groundwater concentration that might be expected in shallow unconfined aquifers under sandy soils.  The output is used for both acute and chronic endpoints.

FIRST concentrations (ppb) represent untreated surface water concentrations.  The one-in-10-year peak day concentration is used for acute endpoints and the one-in-10-year annual average concentration is used for chronic endpoints.

The EDWCs provided in this assessment are conservative estimates of concentrations in drinking water.  If dietary risks require refinement, higher tiered crop-specific and location-specific models and modeling scenarios can be used.

Uncertainties and Data Gaps

This assessment is based on available environmental fate data.  There are no significant data gaps in the environmental fate database submitted by the registrant.  One uncertainty is that the EDWCs represent untreated surface water concentrations.  While treatment systems utilizing UV light may help degrade parent fludioxonil, which is susceptible to photodegradation, specific drinking water treatment effects on fludioxonil are unknown.  Another uncertainty is associated with the use of SCI-GROW and the Koc value used to determine the EDWC for groundwater sources of drinking water.  SCI-GROW was developed using Koc values ranging from 32-180 mL/goc,while the Koc for fludioxonil is 1370.  Extrapolation beyond the values used to develop the model increase the uncertainty associated with the groundwater EDWC.

REFERENCES

Goring, C.A.I., D.A. Laskowki, J.H. Hamaker, and R.W. Meikle. 1975. Principles of pesticide degradation in soil. Pages 135-172 in (R. Haque and V.H. Freed, eds.) Environmental dynamics of pesticides. Plenum Press, New York.

Jones, R. D., S. Abel, W. R. Effland, R. Matzner, R. Parker.  1998.  An Index Reservoir for Use in
Assessing Drinking Water Exposure.  Proposed Methods for Basin-scale Estimation of Pesticide
Concentrations in Flowing Water and Reservoirs for Tolerance Reassessment.  Presentation to FIFRA
Science Advisory Panel, June 29-30, 1998.  Online at: http://www.epa.gov/scipoly/sap/1998/index.htm

Syngenta.  2011.  Fludioxonil Registration Review Public Comments Response to Initial 60-Day Comment Period, Case Number: 7017, Docket Number: EPA-HQ-OPP-2010-1067.  Syngenta.  Greensboro, NC. Sept. 9, 2011.

USEPA. 2002. SCIGROW: Users Manual. Online at: http://www.epa.gov/oppefed1/models/water/#scigrow

USEPA. 2005. EXAMS User's Manual. Online at: http://www.epa.gov/ceampubl/swater/exams/index.html

USEPA. 2006. PRZM User's Manual. Online at: http://www.epa.gov/ceampubl/gwater/przm3/index.html

USEPA.  2009a.  Guidance for Selecting Input Parameters in Modeling the Environmental Fate and Transport of Pesticides.  U.S. Environmental Protection Agency, Office of chemical Safety and Pollution Prevention, Office of Pesticide Programs, Environmental Fate and Effects Division, Oct. 22, 2009.  Online at: http://www.epa.gov/oppefed1/models/water/input_parameter_guidance.htm

USEPA.  2009b.  Tier I Drinking Water Assessment for Fludioxonil. U.S. Environmental Protection
Agency, Office of Prevention, Pesticides and Toxic Substances.  DP 364264.  June 22, 2009.

USEPA. 2009c.  Tier II Drinking Water Assessment for the Fludioxonil Proposed Use on Ornamentals.
U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances.  DP
368586.  August 27, 2009.

USEPA. 2010. Development and Use of Percent Cropped Area Adjustment Factors in Drinking Water Exposure Assessments. U.S. Environmental Protection Agency, Office of chemical Safety and Pollution Prevention, Office of Pesticide Programs, Environmental Fate and Effects Division, September 9, 2010. Online at: http://www.epa.gov/oppefed1/models/water/pca_adjustment_dwa.html

APPENDIX A. MODEL OUTPUT FILES

              TIER I SURFACE WATER MODELING OUTPUT FILES (FIRST)

   RUN No.   1 FOR fludioxonil      ON   ornamental    * INPUT VALUES *
   --------------------------------------------------------------------
    RATE (#/AC)   No.APPS &   SOIL  SOLUBIL  APPL TYPE  %CROPPED INCORP
     ONE(MULT)    INTERVAL    Koc   (PPM )   (%DRIFT)     AREA    (IN)
   --------------------------------------------------------------------
  2.000(  2.000)   1   1     991.0    1.5   GROUND( 6.4) 100.0    .0

   FIELD AND RESERVOIR HALFLIFE VALUES (DAYS)
   --------------------------------------------------------------------
   METABOLIC  DAYS UNTIL  HYDROLYSIS   PHOTOLYSIS   METABOLIC  COMBINED
    (FIELD)  RAIN/RUNOFF  (RESERVOIR)  (RES.-EFF)   (RESER.)   (RESER.)
   --------------------------------------------------------------------
    294.90        2          N/A      8.70- 1078.80      .00   1078.80

   UNTREATED WATER CONC (MICROGRAMS/LITER (PPB)) Ver 1.1.0  JAN 1, 2007
   --------------------------------------------------------------------
        PEAK DAY  (ACUTE)      ANNUAL AVERAGE (CHRONIC)
          CONCENTRATION             CONCENTRATION
   --------------------------------------------------------------------
                             83.845                     38.491

                   TIER I GROUND WATER MODELING OUTPUT FILES

                              SCIGROW
                                  VERSION 2.3
                    ENVIRONMENTAL FATE AND EFFECTS DIVISION
                         OFFICE OF PESTICIDE PROGRAMS
                     U.S. ENVIRONMENTAL PROTECTION AGENCY
                                SCREENING MODEL
                        FOR AQUATIC PESTICIDE EXPOSURE

SciGrow version 2.3
chemical:Fludioxonil
time is  5/12/2009  15:17:05
-----------------------------------------------------------------------
  Application      Number of       Total Use    Koc      Soil Aerobic
  rate (lb/acre)  applications   (lb/acre/yr)  (ml/g)   metabolism
      (days)
 ----------------------------------------------------------------------
      2.000           1.0           2.000      1.37E+03      230.0
 ----------------------------------------------------------------------
 groundwater screening cond (ppb) =   1.98E-01
 ***********************************************************************


[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)]
[Rules and Regulations]
[Pages 4141-4143]
[FR Doc No: 2018-01639]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2017-N-6598]

Medical Devices; General and Plastic Surgery Devices;
Classification of the Surgical Smoke Precipitator

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the surgical smoke precipitator into class II (special controls). The
special controls that apply to the device type are identified in this
order and will be part of the codified language for the surgical smoke
precipitator's classification. We are taking this action because we
have determined that classifying the device into class II (special
controls) will provide a reasonable assurance of safety and
effectiveness of the device. We believe this action will also enhance
patients' access to beneficial innovative devices, in part by reducing
regulatory burdens.

DATES: This order is effective January 30, 2018. The classification was
applicable on December 20, 2016.

FOR FURTHER INFORMATION CONTACT: Steven Elliott, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2565, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the surgical smoke precipitator as
class II (special controls), which we have determined will provide a
reasonable assurance of safety and effectiveness. In addition, we
believe this action will enhance patients' access to beneficial
innovation, in part by reducing regulatory burdens by placing the
device into a lower device class than the automatic class III
assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate by means of the procedures
for premarket notification under section 510(k) of the FD&C Act and
part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act

of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA shall
classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application in order to market a substantially
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial
equivalence''). Instead, sponsors can use the less-burdensome 510(k)
process, when necessary, to market their device.

II. De Novo Classification

    On May 26, 2015, Alesi Surgical submitted a request for De Novo
classification of the UltravisionTM Visual Field Clearing
System. FDA reviewed the request in order to classify the device under
the criteria for classification set forth in section 513(a)(1) of the
FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on December 20, 2016, FDA issued an order to the
requester classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 878.5050. We have named
the generic type of device surgical smoke precipitator, and it is
identified as a prescription device intended for clearance of the
visual field by precipitation of surgical smoke and other aerosolized
particulate matter created during laparoscopic surgery.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

   Table 1--Surgical Smoke Precipitator Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Electrical shock.......................  Electrical safety testing and
                                          Labeling.
Electromagnetic interference with other  Electromagnetic compatibility
 devices.                                 testing and Labeling.
Infection..............................  Sterilization validation, Shelf-
                                          life validation, and Labeling.
Adverse tissue reaction................  Biocompatibility evaluation.
Tissue injury..........................  Animal testing; Software
                                          verification, validation, and
                                          hazard analysis; and Labeling.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.
    At the time of classification, surgical smoke precipitators are for
prescription use only. Prescription devices are exempt from the
requirement for adequate directions for use for the layperson under
section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR
801.5, as long as the conditions of 21 CFR 801.109 are met (referring
to 21 U.S.C. 352(f)(1)).

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
the guidance document ``De Novo Classification Process (Evaluation of
Automatic Class III Designation)'' have been approved under OMB control
number 0910-0844; the collections of information in 21 CFR part 814,
subparts A through E, regarding premarket approval, have been approved
under OMB control number 0910-0231; the collections of information part
807, subpart E, regarding premarket notification submissions, have been
approved under OMB control number 0910-0120, and the collections of
information in 21 CFR part 801, regarding labeling, have been approved
under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 878

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
878 is amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for part 878 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  878.5050 to subpart F to read as follows:

Sec.  878.5050  Surgical smoke precipitator.

    (a) Identification. A surgical smoke precipitator is a prescription
device intended for clearance of the visual field by precipitation of
surgical smoke and other aerosolized particulate matter created during
laparoscopic surgery.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Adverse tissue reaction must be mitigated through the
following:
    (i) Chemical characterization and toxicological risk assessment of
the treated surgical smoke.
    (ii) Demonstration that the elements of the device that may contact
the patient are biocompatible.
    (2) Electrical safety and electromagnetic compatibility testing
must demonstrate that the device performs as intended.
    (3) Software verification, validation, and hazard analysis must be
performed.
    (4) Performance data must demonstrate the sterility of the patient
contacting components of the device.
    (5) Performance data must support the shelf life of the sterile
components of the device by demonstrating continued functionality,
sterility, and package integrity over the identified shelf life.
    (6) Animal simulated-use testing must demonstrate that the device
performs as intended under anticipated conditions of use. The following
performance characteristics must be tested:
    (i) Device must be demonstrated to be effectively inserted,
positioned, and removed from the site of use.
    (ii) Device must be demonstrated to precipitate surgical smoke
particulates to clear the visual field for laparoscopic surgeries.
    (iii) Device must be demonstrated to be non-damaging to the site of
use and animal subject.
    (7) Labeling must identify the following:
    (i) Detailed instructions for use.
    (ii) Electrical safety and electromagnetic compatibility
information.
    (iii) A shelf life.

    Dated: January 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01639 Filed 1-29-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: December 23, 2005 (Volume 70, Number 246)]
[Notices]
[Page 76276-76277]
[DOCID:fr23de05-58]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP06-33-000]

Tennessee Gas Pipeline Company, Southern Natural Gas Company;
Notice of Abbreviated Joint Application for a Certificate of Public
Convenience and Necessity for Authorization To Abandon a Transportation
and Exchange Service

December 13, 2005.
    Take notice that on December 6, 2005, Tennessee Gas Pipeline
Company (Tennessee) and Southern Natural Gas Company (Southern) jointly
filed an abbreviated application with the Commission for a certificate
of public convenience and necessity pursuant to section 7(b) of the
Natural Gas Act and part 157 the Commission's Rules and Regulations for
authorization to abandon a certificated transportation and exchange
service performed pursuant to Tennessee Rate Schedule T-157 and
Southern Rate Schedule X-71 all as more fully set forth in the
application on file with the Commission and open to public inspection.
    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 and 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. Such notices,
motions, or protests must be filed on or before the date as indicated
below. Anyone filing an intervention or protest must serve a copy of
that document on the Applicant. Anyone filing an intervention or
protest on or before the intervention or protest date need not serve
motions to intervene or protests on persons other than the Applicant.
    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 14 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 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 e-mail notification when a document is added to
a subscribed docket(s). For assistance with any FERC Online service,
please e-mail<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll
free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m., Eastern time on January 3, 2006.

Magalie R. Salas,
Secretary.
[FR Doc. E5-7744 Filed 12-22-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 216 (Thursday, November 7, 2019)]
[Notices]
[Pages 60094-60095]
[FR Doc No: 2019-24332]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3768]

Best Practices in Drug and Biological Product Postmarket Safety
Surveillance for Food and Drug Administration Staff; Draft Document;
Availability; Establishment of Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; establishment of public docket; request
for comments.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is
establishing a public docket to collect comments on a draft document
that details best practices for drug safety surveillance entitled
``Best Practices in Drug and Biological Product Postmarket Safety
Surveillance for FDA Staff.'' The 21st Century Cures Act (Cures Act)
was enacted on December 13, 2016, and requires that FDA make publicly
available on its internet website best practices for drug safety
surveillance activities. The draft document sets forth risk-based
principles by which FDA conducts ongoing postmarketing safety
surveillance for drug and biological products to address the Cures Act
requirements. FDA is seeking public comment on the draft best practices
in drug and biological product postmarket safety surveillance.

DATES: Submit either electronic or written comments on the draft
document by January 6, 2020 to ensure that the Agency considers your
comment on this draft document before it begins work on the final
version.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-N-3768 for ``Best Practices in Drug and Biological Product
Postmarket Safety Surveillance for FDA Staff.'' Received comments will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available

for public viewing and posted on 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: Eileen Wu, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 3472, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>or Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is establishing a public docket to collect comments on a draft
document entitled ``Best Practices in Drug and Biological Product
Postmarket Safety Surveillance for FDA Staff.'' Title IX, section 915
of the Food and Drug Administration Amendments Act of 2007 (FDAAA)
added a new section 505(r) to the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 355(r)), requiring FDA to prepare a summary
analysis of the adverse drug reaction reports received for a drug by 18
months after approval or after use of the drug by 10,000 individuals,
whichever is later. The analysis includes identification of any new
risks not previously identified, potential new risks, or known risks
reported in unusual number.
    The Cures Act (Pub. L. 114-255) was enacted on December 13, 2016,
and has the goal of advancing medical product innovation, as well as
ensuring patient access to safe and effective treatments as soon as
possible. Section 3075 of the Cures Act amended section 505(r)(2)(D) of
the FD&C Act to eliminate the requirement for summary analyses for
drugs as required by FDAAA. In place of the summary analyses, section
3075 amended section 505(r)(2)(D) of the FD&C Act to include the
requirement that FDA make publicly available on its internet website
best practices for drug safety surveillance activities for drugs
approved under section 505 of the FD&C Act or section 351 of the Public
Health Service Act (PHS Act).
    Section 3075 of the Cures Act also amended section 505(k)(5) of the
FD&C Act to strike ``bi-weekly screening'', as required by FDAAA, and
insert ``screenings''; it also added the requirement that FDA make
publicly available on its internet website guidelines, developed with
input from experts qualified by scientific training and experience to
evaluate the safety and effectiveness of drugs, that detail best
practices for drug safety surveillance using the Adverse Event
Reporting System.
    The draft document entitled ``Best Practices in Drug and Biological
Product Postmarket Safety Surveillance for FDA Staff'' sets forth risk-
based principles by which FDA conducts ongoing postmarketing safety
surveillance for drug and biological products to address the Cures Act
requirements. Although section 3075 of the Cures Act only references
drugs approved under section 505 of the FD&C Act or section 351 of the
PHS Act, the draft document additionally provides a high-level
discussion regarding other products, including over-the-counter
monograph, compounded, and homeopathic drug products. The draft
document also includes a high-level overview of other data sources,
tools, and methods, as well as drug safety surveillance activities that
extend beyond use of the Adverse Event Reporting System (and its
successors). These additional topics are included to provide context
and a general overview of FDA's safety surveillance process. FDA is
seeking public comment on the draft best practices document before it
begins work on the final version, which will be made publicly
available.

II. Electronic Access

    Persons with access to the internet may obtain the draft document
entitled ``Best Practices in Drug and Biological Product Postmarket
Safety Surveillance for FDA Staff'' at https://www.fda.gov/media/130216/download.

    Dated: November 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24332 Filed 11-6-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 99 (Wednesday, May 22, 2019)]
[Notices]
[Pages 23607-23610]
[FR Doc No: 2019-10645]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85881; File No. SR-CboeBZX-2019-042]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule To Amend the Fees
Applicable to Securities Listed on the Exchange, Set Forth in BZX Rule
14.13, Company Listing Fees

May 16, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on May 3, 2019, Cboe BZX Exchange, Inc. (the ``Exchange'' or
``BZX'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes a rule change to amend the fees applicable to
securities listed on the Exchange, which are set forth in BZX Rule
14.13, Company Listing Fees. Changes to the fee schedule pursuant to
this proposal are effective upon filing.
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/equities/regulation/rule_filings/bzx/), at the Exchange's Office of the Secretary, and at
the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    On August 30, 2011, the Exchange received approval of rules
applicable to the qualification, listing, and delisting of companies on
the Exchange,\3\ which it modified on February 8, 2012 in order to
adopt pricing for the listing of exchange traded products (``ETPs'')
\4\ on the Exchange.\5\ On July 3, 2017, the Exchange made certain
changes to Rule 14.13 such that there were no entry fees or annual fees
for ETPs listed on the Exchange.\6\ Effective January 1, 2019, the
Exchange made certain changes to Rule 14.13 in order to charge an entry
fee for ETPs that are not Generically-Listed ETPs \7\ and to add annual
listing fees for ETPs listed on the Exchange.\8\ The Exchange submits
this proposal in order to amend Rule 14.13 in order to include Linked
Securities \9\ in the definition of Generically-Listed ETPs, to create
pricing specific to Transfer Listings, as defined below, and to add
Linked Securities to the standard annual fee schedule applicable other
(sic) ETPs. In conjunction with this last change, the Exchange is
proposing to eliminate Rule 14.13(b)(2)(C)(v), which currently applies
only to certain Linked Securities.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 65225 (August 30,
2011), 76 FR 55148 (September 6, 2011) (SR-BATS-2011-018).
    \4\ As defined in Rule 11.8(e)(1)(A), the term ``ETP'' means any
security listed pursuant to Exchange Rule 14.11.
    \5\ See Securities Exchange Act Release No. 66422 (February 17,
2012), 77 FR 11179 (February 24, 2012) (SR-BATS-2012-010).
    \6\ See Securities Exchange Act Release No. 81152 (July 14,
2017), 82 FR 33525 (July 20, 2017) (SR&BatsBZX-2017-45).
    \7\ As currently defined, the term ``Generically-Listed ETPs''
means Index Fund Shares, Portfolio Depositary Receipts, Managed Fund
Shares, Linked Securities, (sic) and Currency Trust Shares that are
listed on the Exchange pursuant to Rule 19b-4(e) under the Exchange
Act and for which a proposed rule change pursuant to Section 19(b)
of the Exchange Act is not required to be filed with the Commission.
    \8\ See Securities Exchange Act Release No. 83597 (July 5,
2018), 83 FR 32164 (July 11, 2018) (SR-CboeBZX-2018-46).
    \9\ As defined in Rule 14.11(d), the term ``Linked Securities''
includes any product listed pursuant to Rule 14.11(d), but
specifically includes Equity Index-Linked Securities, Commodity-
Linked Securities, Fixed Income Index-Linked Securities, Futures-
Linked Securities, and Multifactor Index-Linked Securities.
---------------------------------------------------------------------------

Generically-Listed ETPs--Linked Securities
    Currently, Generically-Listed ETPs listed on the Exchange are not
subject to an entry fee on the Exchange, as provided in Rule
14.13(b)(1)(C)(ii). The reason that Generically-Listed ETPs are not
subject to an entry fee on the Exchange is that they generally do not
require the same additional resources as ETPs that require a proposed
rule change pursuant to Section 19(b), specifically the significant
additional time and extensive legal and business resources required by
Exchange staff to prepare and review such filings and to communicate
with issuers and the Commission regarding such filings.
    The Exchange is proposing to add Linked Securities to the
definition of Generically-Listed ETPs, meaning that any series of
Linked Securities that is listed on the Exchange pursuant to Rule 19b-
4(e) under the Act and for which a proposed rule change pursuant to
Section 19(b) of the Act is not required to be filed with the
Commission would not pay any entry fee for listing on the

Exchange.\10\ Any series of Linked Securities that is not listed
pursuant to Rule 19b-4(e) and would require a proposed rule change
pursuant to Section 19(b) of the Act would still be subject to the
entry fees applicable under Rule 14.13(b)(1)(C)(i).
---------------------------------------------------------------------------

    \10\ The Exchange notes that NYSE Arca, Inc. (``Arca'')
similarly does not charge an entry fee for Linked Securities that
are listed pursuant to Rule 19b-4(e) under the Act and for which a
proposed rule change pursuant to Section of the Act is not required
to be filed with the Commission. See Arca Listing Fee Schedule for
Structured Products, available: https://www.nyse.com/publicdocs/nyse/markets/nyse-arca/NYSE_Arca_Listing_Fee_Schedule.pdf.
---------------------------------------------------------------------------

Transfer Listings
    Currently, any ETP that transfers its listing to the Exchange from
another national securities exchange is subject to the same fee
schedule as a newly-listed ETP. In order to enhance the competitive
environment in the exchange listing space, the Exchange is proposing
certain fees specifically for Transfer Listings.\11\ Specifically, the
Exchange is proposing that Transfer Listings would not be subject to an
entry fee, would have an annual listing fee of $4,000, and would not be
subject to an annual fee for the remainder of the calendar year
following the date of listing on the Exchange.\12\
---------------------------------------------------------------------------

    \11\ As part of this proposal, the Exchange is also proposing to
amend Rule 14.13(b)(1)(C)(ii) to include the defined term ``Transfer
Listing,'' which shall mean any ETP that transfers its listing from
another national securities exchange to the Exchange.
    \12\ The waiver of the annual fee for Transfer Listings is
substantively identical to fees currently implemented on Arca. See
Arca Listing Fee Schedule, Waiver of Annual Fee for Transfer
Listings, available: https://www.nyse.com/publicdocs/nyse/markets/nyse-arca/NYSE_Arca_Listing_Fee_Schedule.pdf.
---------------------------------------------------------------------------

Linked Securities--Annual Fees
    Currently, where an ETP is not a Legacy Listing,\13\ a New
Listing,\14\ or an Auction Fee Listing,\15\ but is a series of Linked
Securities, such an ETP will be subject to the following annual listing
fee based on the CADV in the fourth quarter of the preceding calendar
year:
---------------------------------------------------------------------------

    \13\ A Legacy Listing, as defined in Rule 14.13(b)(2)(C)(i), is
any ETP that was listed on the Exchange prior to January 1, 2019.
All ETPs listed on the Exchange that are a Legacy Listing have an
annual listing fee of $4,000.
    \14\ A New Listing, as defined in Rule 14.13(b)(2)(C)(ii), is an
ETP during its first calendar year being listed on the Exchange or
an ETP in its second calendar year being listed on the Exchange that
was listed in the fourth quarter of its first calendar year. All New
Listings have an annual listing fee of $4,500.
    \15\ An ``Auction Fee Listing, as defined in Rule
14.13(b)(2)(C)(iii), refers to each of an issuer's ETPs where the
average daily auction volume combined between the opening and
closing auctions on the Exchange across all of an issuer's ETPs
listed on the Exchange exceeds 500,000 shares. Auction Fee Listings
have no annual listing fee.

------------------------------------------------------------------------
                                                                 Annual
                          CADV range                             listing
                                                                   fee
------------------------------------------------------------------------
0-10,000 shares...............................................   $15,000
10,001-100,000 shares.........................................    14,000
100,001-1,000,000 shares......................................    13,000
Greater than 1,000,000 shares.................................    12,000
------------------------------------------------------------------------

    The Exchange is proposing to eliminate this fee structure entirely
by deleting Rule 14.13(b)(2)(C)(v) and to amend Rule 14.13(b)(2)(C)(iv)
to include Linked Securities such that the annual listing fees
applicable to all ETPs that are not a Legacy Listing, a New Listing, an
Auction Fee Listing, or, as proposed herein, a Transfer Listing, apply
as follows:

------------------------------------------------------------------------
                                                                 Annual
                          CADV range                             listing
                                                                   fee
------------------------------------------------------------------------
0-10,000 shares...............................................    $7,000
10,001-100,000 shares.........................................     6,000
100,001-1,000,000 shares......................................     5,500
Greater than 1,000,000 shares.................................     5,000
------------------------------------------------------------------------

    This change would reduce fees for Linked Securities that are not a
Legacy Listing, New Listing, or Auction Fee Listing by more than 50%
and would either reduce or keep the same the annual fees for all Linked
Securities listed on the Exchange.
Implementation Date
    The Exchange proposes to implement these amendments to its fees on
May 3, 2019.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder that are applicable to a national securities exchange, and,
in particular, with the requirements of Section 6 of the Act.\16\
Specifically, the Exchange believes that the proposed rule change is
consistent with Section 6(b)(4) and 6(b)(5) of the Act,\17\ in that it
provides for the equitable allocation of reasonable dues, fees and
other charges among issuers and it does not unfairly discriminate
between customers, issuers, brokers or dealers.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78f.
    \17\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

Generically-Listed ETPs--Linked Securities
    The Exchange believes that the proposed amendment to Rule
14.13(b)(1)(C) to include Linked Securities in the definition of
Generically-Listed ETPs and, thus eliminate the entry fee for Linked
Securities that are listed on the Exchange pursuant to Rule 19b-4(e)
under the Act and for which a proposed rule change pursuant to Section
19(b) of the Act is not required to be filed with the Commission is a
reasonable, fair and equitable, and not unfairly discriminatory
allocation of fees and other charges because it would apply equally for
all issuers and all Linked Securities. The Exchange believes that
eliminating the entry fee for Linked Securities that are Generically-
Listed ETPs is reasonable given that the resources necessary for
bringing such listings to market are generally consistent with those
ETPs currently included in the definition of Generically-Listed ETPs.
Further, the Exchange believes that it is reasonable, fair and
equitable, and not unfairly discriminatory to distinguish between
Linked Securities that are Generically-Listed ETPs and those Linked
Securities that are not Generically-Listed ETPs because of the
additional resources required by the Exchange in connection with ETPs
requiring a proposed rule change pursuant to Section 19(b),
specifically the significant additional time and extensive legal and
business resources required by Exchange staff to prepare and review
such filings and to communicate with issuers and the Commission
regarding such filings. Further, the Exchange notes that this proposal
is not proposing to make any changes to entry fees for Linked
Securities that are not Generically-Listed ETPs. As noted above, Arca
similarly does not charge an entry fee for Linked Securities that are
listed pursuant to Rule 19b-4(e) under the Act and for which a proposed
rule change pursuant to Section of the Act is not required to be filed
with the Commission.\18\
---------------------------------------------------------------------------

    \18\ See Arca Listing Fee Schedule for Structured Products,
available: https://www.nyse.com/publicdocs/nyse/markets/nyse-arca/NYSE_Arca_Listing_Fee_Schedule.pdf.
---------------------------------------------------------------------------

Transfer Listings
    The Exchange believes that it is a reasonable, fair and equitable,
and not unfairly discriminatory allocation of fees and other charges to
eliminate entry fees, eliminate an annual fee for the remainder of the
calendar year following the date of listing on the Exchange, and offer
lower annual listing fees for Transfer Listings because such changes
will incentivize issuers to transfer ETPs to the Exchange, which will
create a more competitive

landscape for ETP listing venues, to the benefit of all issuers, ETPs,
and investors in ETPs. More specifically, the Exchange believes that it
is a reasonable, fair and equitable, and not unfairly discriminatory
allocation of fees and other charges to eliminate entry fees for
Transfer Listings because Transfer Listings that would otherwise be
subject to entry fees on the Exchange: (i) Generally require fewer
Exchange resources to list on the Exchange than new ETP listings that
are subject to an entry fee on the Exchange; and (ii) have generally
already paid an entry fee on another listing venue and having to pay
such fee again would be a strong disincentive to transferring the ETP
to the Exchange.
    Similarly, the Exchange believes that it is a reasonable, fair and
equitable, and not unfairly discriminatory allocation of fees and other
charges to not charge an annual fee for the remainder of the calendar
year after transferring to the Exchange because such Transfer Listing
would have already paid an annual listing fee to the national
securities exchange that they are currently listed on and requiring
payment of an annual fee would essentially be double-charging an annual
fee and would act as a strong disincentive for transferring the listing
to the Exchange.\19\
---------------------------------------------------------------------------

    \19\ As noted above, the waiver of the annual fee is
substantively identical to fees currently implemented on Arca. See
Arca Listing Fee Schedule, Waiver of Annual Fee for Transfer
Listings, available: https://www.nyse.com/publicdocs/nyse/markets/nyse-arca/NYSE_Arca_Listing_Fee_Schedule.pdf.
---------------------------------------------------------------------------

    The Exchange also believes that the proposed change to charge a
$4,000 annual fee to Transfer Listings is not unfairly discriminatory
because it will: (i) Incentivize ETPs to transfer their listing to the
Exchange; (ii) provide Transfer Listings with certainty related to
annual fees on the Exchange; (iii) create a small distinction in
pricing that will enhance competition among ETP listing venues to the
benefit of all ETPs, issuers, and investors; (iv) is generally in line
with additional reduced fees available to ETPs currently listed on the
Exchange; and (v) is available to all issuers and ETPs that transfer
ETP listings to the Exchange.
    The Exchange notes that the rationale behind this proposed change
is very similar to that of the Legacy Listing fees. Specifically, the
Legacy Listing fees were designed to incentivize transfers to the
Exchange in advance of the implementation of ETP listing fees on the
Exchange on January 1, 2019, and to provide long-term certainty around
annual fees for all ETPs listed on the Exchange. Similarly, the
Exchange is proposing to make this change in order to incentivize ETP
transfers to the Exchange, but also to provide such Transfer Listings
with long-term certainty related to annual fees. While the Legacy
Listings pricing applies equally to all issuers (whether transferred or
originally listed on the Exchange) and the proposed annual fees for
Transfer Listings would not apply to ETPs already listed on the
Exchange, the Exchange believes that such a distinction is justified
based on the overall enhancement to competition among market
participants that results from such pricing. Further, the Exchange does
not believe that this proposed change represents a significant
departure from previous pricing offered by the Exchange or pricing
offered by the Exchange's competitors and notes that the Exchange's
annual fees for ETP listing generally remain lower than other national
securities exchanges. Further, the Exchange is not proposing to raise
the annual fee for any ETPs listed on the Exchange and, as such, there
is no negative impact to ETPs listed on the Exchange (either currently
or in the future) that are not Transfer ETPs. The Exchange also notes
that issuers and ETPs may opt to disfavor the Exchange's pricing if
they believe that alternatives offer them a better value.
    The Exchange further notes that this proposed change is also
similar to listing fees implemented by Investors Exchange, LLC
(``IEX'') in 2017.\20\ Specifically, IEX offered credits of at least
$250,000 to be paid out over up to five years to corporate issuers that
announced a transfer of their listing to IEX within 120 days of the
first listing on IEX. Similar to what the Exchange is proposing, such
credits were not applicable to a new listing that was not a transfer.
The Exchange believes that the policy issues and arguments underlying
the IEX Transfer Incentive Filing are nearly identical to those
applicable to this proposed change, with the exception of the scope of
payments applicable under this proposed change. Assuming the greatest
possible annual fee savings, it would take a Transfer Listing 83-plus
years to receive the same economic benefit as was proposed as a minimum
on an annual basis (sic) under the IEX Transfer Incentive Filing.\21\
---------------------------------------------------------------------------

    \20\ See Securities Exchange Act Release No. 81725 (September
26, 2017), 82 FR 45917 (October 2, 2017) (SR-IEX-2017-30) (the ``IEX
Transfer Incentive Filing'').
    \21\ The greatest annual fee for an ETP listed on the Exchange
is $7,000 (applicable only to those ETPs that have fewer than 10,000
shares traded per day), compared to the proposed $4,000 annual fee
for Transfer Listings would make a difference of $3,000 annually.
$250,000/$3,000 = 83.33.
---------------------------------------------------------------------------

    The Exchange further believes that the proposed change to charge a
$4,000 annual fee to Transfer Listings is a reasonable, fair and
equitable, and not unfairly discriminatory allocation of fees and other
charges because it represents a relatively small difference in annual
fees while working to promote transfers and enhance competition among
ETP listing venues. While ETPs that are currently listed on the
Exchange would be subject to the Exchange's standard annual listing fee
schedule, such fee schedule provides New Listings with reduced pricing
($4,500 annual listing fee prorated based on number of trading days
remaining in the year, as described above), as well as more established
ETPs with reduced annual fees as the trading volume in the product
increases. The Exchange further eliminates the annual fee entirely for
all Auction Fee Listings as well. As such, the Exchange believes that
the benefit to the broader marketplace that comes from increased
competition among ETP listing venues significantly outweighs any
concerns related to discrimination in fees because of the several
additional ways that ETPs can achieve reduced annual fees combined with
the relatively insubstantial difference in pricing for existing
listings as compared to Transfer Listings.
Linked Securities--Annual Fees
    The Exchange believes that the proposed amendment to delete Rule
14.13(b)(2)(C)(v) and to amend Rule 14.13(b)(2)(C)(iv) such that the
standard annual listing fees would be applicable to Linked Securities
is a reasonable, fair and equitable, and not unfairly discriminatory
allocation of fees and other charges because it would create a
consistent application of fees and other charges applicable to all
issuers and ETPs listed on the Exchange. Further, such fees generally
reflect the additional revenue that an ETP listed on the Exchange
creates for the Exchange through executions occurring in the auctions
and additional shares executed on the Exchange. Listing exchanges
generally receive an outsized portion of intraday trading activity and
receive all auction volume for ETPs listed on the exchange. The higher
the CADV for an ETP, the greater the likely income the Exchange will
receive based on outsized intraday trading activity and auction volume
for such ETP. As such, the Exchange offers lower annual listing fees
for ETPs listed on the Exchange as their CADV increases. This structure
is designed to reward the issuer of an ETP

for such additional revenue brought to the Exchange as CADV increases,
which the Exchange believes creates a more equitable and appropriate
fee structure for issuers based on the revenue and expenses associated
with listing ETPs on the Exchange. Finally, the Exchange notes that
such change will simplify the Exchange's ETP fee schedule by having a
single set of fees based on CADV apply to all types of ETPs listed on
the Exchange.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. With respect to the proposed
elimination of entry fees for Linked Securities that qualify as
Generically-Listed ETPs, the Exchange does not believe that the changes
burden competition, but instead, enhance competition by reducing the
cost associated with bringing Linked Securities to market and bringing
such cost more in line with the cost of resources associated with
bringing such a listing to market for the Exchange. With respect to the
reduction of fees associated with Transfer Listings, the Exchange
believes that such proposed changes will directly enhance competition
among ETP listing venues by reducing the costs associated with
transferring listings between such venues. Similarly, the Exchange
believes that reducing standard annual fees for Linked Securities to
bring them in line with all other ETP types on the Exchange will
enhance competition both among listing venues of Linked Securities and
among issuers and issuances of Linked Securities through an overall
reduction of annual fees for listing such products. As such, the
proposal is a competitive proposal designed to enhance pricing
competition among listing venues and implement pricing for listings
that better reflects the revenue and expenses associated with listing
ETPs on the Exchange.
    The Exchange does not believe the proposed amendments would burden
intramarket competition as they would be available to all issuers
uniformly.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from Members or other interested
parties.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \22\ and paragraph (f) of Rule 19b-4 \23\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
---------------------------------------------------------------------------

    \22\ 15 U.S.C. 78s(b)(3)(A).
    \23\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CboeBZX-2019-042 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CboeBZX-2019-042. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-CboeBZX-2019-042 and should be submitted
on or before June 12, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\24\
---------------------------------------------------------------------------

    \24\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-10645 Filed 5-21-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: September 20, 2007 (Volume 72, Number 182)]
[Proposed Rules]
[Page 53709-53711]
[DOCID:fr20se07-19]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-29256; Directorate Identifier 2007-NM-137-AD]
RIN 2120-AA64

Airworthiness Directives; Fokker Model F.28 Mark 0070 and 0100
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as:

    Two events have been reported of Fokker 100 (F.28 Mk.0100)
aircraft, where the Nose Landing Gear (NLG) failed to extend in the

normal mode and problems were experienced to open the NLG doors,
almost preventing extension of the NLG in the emergency (alternate)
mode. Subsequent investigation and tests have shown that the
friction of the bearing in the roller of the NLG Door Uplock Bracket
Assembly is high, causing increased resistance in the mechanical
system that unlocks the NLG doors. This condition, if not corrected,
may result in a NLG up landing, which is considered a hazardous
event.

    The proposed AD would require actions that are intended to address
the unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by October 22,
2007.

ADDRESSES: You may send comments by any of the following methods:
     DOT Docket Web Site: Go to http://dms.dot.gov and follow

the instructions for sending your comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: Room W12-140 on the ground floor of the
West Building, 1200 New Jersey Avenue, SE., Washington, DC, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the instructions for submitting comments.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://dms.dot.gov
; or in person at the Docket Operations office between 9

a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this proposed AD, the regulatory evaluation, any
comments received, and other information. The street address for the
Docket Operations office (telephone<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, FAA, Transport Airplane Directorate,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-1137; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2007-
29256; Directorate Identifier 2007-NM-137-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://dms.dot.gov
, including any personal information you provide. We will

also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The Civil Aviation Authority--The Netherlands (CAA-NL), which is
the aviation authority for the Netherlands, has issued Dutch
Airworthiness Directive NL-2006-004, dated February 28, 2006 (referred
to after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    Two events have been reported of Fokker 100 (F.28 Mk.0100)
aircraft, where the Nose Landing Gear (NLG) failed to extend in the
normal mode and problems were experienced to open the NLG doors,
almost preventing extension of the NLG in the emergency (alternate)
mode. Subsequent investigation and tests have shown that the
friction of the bearing in the roller of the NLG Door Uplock Bracket
Assembly is high, causing increased resistance in the mechanical
system that unlocks the NLG doors. This condition, if not corrected,
may result in a NLG up landing, which is considered a hazardous
event. Since a potentially unsafe condition has been identified that
may exist or develop on aircraft of the same type design, this
Airworthiness Directive requires the introduction of an improved
roller in the NLG Door Uplock Bracket Assembly.

You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    Fokker Services B.V. has issued Service Bulletin SBF100-32-143,
dated February 15, 2006, and Component Service Bulletin D76501-32-17,
dated February 15, 2006. The actions described in this service
information (replacing the roller in the uplock bracket) are intended
to correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the proposed AD.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 13 products of U.S. registry. We also estimate that
it would take about 5 work-hours per product to comply with the basic
requirements of this proposed AD. The average labor rate is $80 per
work-hour. Required parts would cost about $135 per product. Where the
service information lists required parts costs that are covered under
warranty, we have assumed that there will be no charge for these costs.
As we do not control warranty coverage for affected parties, some
parties may incur costs higher than estimated here. Based on these
figures, we estimate the cost of the proposed AD on U.S. operators to
be $6,955, or $535 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for

safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

    1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Fokker Services B.V.: Docket No. FAA-2007-29256; Directorate
Identifier 2007-NM-137-AD.

Comments Due Date

    (a) We must receive comments by October 22, 2007.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Fokker Model F.28 Mark 0070 and 0100
airplanes, certificated in any category, all serial numbers.

Subject

    (d) Air Transport Association (ATA) of America Code 32: Landing
gear.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    Two events have been reported of Fokker 100 (F.28 Mk.0100)
aircraft, where the Nose Landing Gear (NLG) failed to extend in the
normal mode and problems were experienced to open the NLG doors,
almost preventing extension of the NLG in the emergency (alternate)
mode. Subsequent investigation and tests have shown that the
friction of the bearing in the roller of the NLG Door Uplock Bracket
Assembly is high, causing increased resistance in the mechanical
system that unlocks the NLG doors. This condition, if not corrected,
may result in a NLG up landing, which is considered a hazardous
event. Since a potentially unsafe condition has been identified that
may exist or develop on aircraft of the same type design, this
Airworthiness Directive requires the introduction of an improved
roller in the NLG Door Uplock Bracket Assembly.

Actions and Compliance

    (f) Unless already done, do the following actions.
    (1) Within 4,000 flight hours after the effective date of this
AD, modify the NLG Door Uplock Bracket Assembly, in accordance with
the Accomplishment Instructions of Fokker Service Bulletin SBF100-
32-143, dated February 15, 2006.
    (2) As of 18 months after the effective date of this AD, no
spare NLG Door Uplock Bracket Assembly may be installed as a
replacement part unless it has been modified in accordance with the
Accomplishment Instructions of Fokker Component Service Bulletin
D76501-32-17, dated February 15, 2006.

FAA AD Differences

    Note: This AD differs from the MCAI and/or service information
as follows: No difference.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. Send information to ATTN: Tom Rodriguez, Aerospace Engineer,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425) 227-1137; fax<PHONE_NUMBER>. Before using any approved AMOC
on any airplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act, the
Office of Management and Budget (OMB) has approved the information
collection requirements and has assigned OMB Control Number 2120-
0056.

Related Information

    (h) Refer to MCAI Dutch Airworthiness Directive NL-2006-004,
dated February 28, 2006, Fokker Service Bulletin SBF100-32-143,
dated February 15, 2006, and Fokker Component Service Bulletin
D76501-32-17, dated February 15, 2006, for related information.

    Issued in Renton, Washington, on September 12, 2007.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E7-18553 Filed 9-19-07; 8:45 am]

BILLING CODE 4910-13-P