  SEQ CHAPTER \h \r 1

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

  SEQ CHAPTER \h \r 1 MEMORANDUM

Date:  3/15/2010

SUBJECT:	Fluazinam  Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for the Section 3 Registration Action on Apples, Carrots, Head Lettuce, Leaf Lettuce, and the Bulb Onion Subgroup (3-07A)

PC Code:  129098	DP Barcodes:  D374522

Decision No.:  404254	Registration No.: 71512-1

Petitions:  8E7506, 9E7570, and 9F7571	Regulatory Action:  Section 3 Registration

Risk Assessment Type:  NA	Case No.:  NA

TXR No.:  NA	CAS No.:    SEQ CHAPTER \h \r 1 79622-59-6

MRID Nos.:  NA	40 CFR:  §180.574

FROM:  	Douglas Dotson, Ph.D., Chemist

		Risk Assessment Branch II

		Health Effects Division (7509P)	  SEQ CHAPTER \h \r 1

THROUGH:	Toiya Goodlow, Chemist

		Debra Rate, Ph.D., Biologist

		Dietary Exposure Science Advisory Council

TO:		Laura Nollen/Barbara Madden, RM Team 5, RIMUERB

		John Bazuin/Tony Kish, PM Team 22, Fungicide Branch

		Registration Division (7505P)		  SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1

Executive Summary

water) exposure and risk assessments were conducted using the Dietary Exposure Evaluation Model DEEM-FCID™, Version 2.03 which uses food consumption data from the U.S. Department of Agriculture’s Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.  The analyses were conducted as part of a human health risk assessment for the requested uses of fluazinam on apples, carrots, head lettuce, leaf lettuce, and the Bulb onion subgroup (3-07A).

The acute analysis is based on tolerance-level residues for all commodities and uses high-end residue estimates for the metabolite AMGT.  In addition, the acute assessment assumes 100% crop treated and incorporates modeled estimated drinking water concentrations (EDWCs) that account for both parent fluazinam and its transformation products.  Therefore, the resulting exposure and risk estimates are considered to be very conservative.  The acute risk estimates are below HED’s level of concern for all population subgroups, including those comprised of infants and children.  Generally, HED is concerned when risk estimates exceed 100% of the population-adjusted dose (PAD).  The acute risk estimate for the general U.S. population is 4.1% of the acute PAD (aPAD).  The most highly exposed population subgroup is Females 13-49, which uses 20% of the aPAD.

The chronic analysis is based on tolerance-level residues for all commodities except apples.  For apples, the average field trial value was used.  As with the acute assessment, it assumes high-end estimates for AMGT, 100% crop treated, and incorporates modeled EDWCs that account for both parent and transformation products.  Again, the resulting exposure and risk estimates are considered to be conservative.  Chronic risk estimates are also below HED’s level of concern for all population subgroups.  The risk estimate for the general U.S. population is 14% of the chronic PAD (cPAD).  The most highly exposed population subgroup is All Infants (<1 year old), which uses 40% of the cPAD.

Fluazinam is classified as having “suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic potential.”  The CARC determined that quantification using a linear low dose approach was not required and the cRfD is protective of cancer effects.  As a result, a separate cancer dietary exposure analysis was not performed.

I.   Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide.  For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in no unreasonable adverse health effects).  This dose is referred to as the population-adjusted dose (PAD).  The PAD is equivalent to point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors.

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD.  References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site:  “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 21 Jun 2000, web link:      HYPERLINK "http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf"  http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf  ; or see SOP 99.6 (20 Aug 1999).

The most recent dietary risk assessment for fluazinam was conducted by M. Doherty (Memo, D340854, 8/1/2007).

II.   Residue Information

Fluazinam is currently registered in the U.S. for use on ginseng, peanuts, potatoes, turnip greens, Crop Group 5 (Brassica leafy vegetables), Subgroup 6A (except pea), Subgroup 6B (except pea), Subgroup 6C (except pea), the Bushberry subgroup (13B), and other bushberries that are included in Subgroup 13-07B but not 13B.  Tolerances range from 0.01 ppm for the Brassica leafy vegetables and turnip greens to 7.0 ppm for the Bushberry subgroup and other bushberries.  In addition, there is a tolerance of 3.0 ppm for residues in/on wine grapes (no U.S. registration).  These tolerances are listed in 40 CFR 180.574.  These commodities were all included in the most recent dietary exposure assessment that was performed for fluazinam (memo, D340854, M. Doherty, 8/1/2007).

The current tolerance petitions include apples, carrots, head lettuce, leaf lettuce, and the Bulb onion subgroup (3-07B).  In addition, the 7.0 ppm tolerance for the Bushberry subgroup (13B) is being replaced by a 7.0 ppm tolerance for the updated Bushberry subgroup (13-07B).  As a result, the individual tolerances for the various bushberry crops that were not a part of subgroup 13-B are being revoked.

HED is recommending in favor of tolerances for lettuce and onions.  However, because of major data deficiencies, HED is not recommending in favor of tolerances for apples and carrots.  Apples and carrots are being included in the assessments, however, because HED is anticipating that the registrant will resolve the data deficiencies and pursue the tolerances for apples and carrots.  As a result, the acute and chronic dietary exposure analyses include residue values for these commodities as well.  Tolerances are currently in effect for potatoes and peanuts.  These commodities have animal feed items associated with them (processed potato waste and peanut meal).  Apples and carrots also have animal feed items associated with them (wet apple pomace and carrot culls).  Because of these animal feed items, HED is including meat byproducts and fat of cattle, goat, horse, and sheep in the acute and chronic dietary exposure analyses.

The residue of concern for risk assessment in root and tuber vegetables and bulb vegetables is parent fluazinam.  For all other plant commodities, the residues of concern in plants for risk assessment are fluazinam and its metabolite AMGT.  Field trial data reflecting AMGT residues were provided for apples, but not for head or leaf lettuce.  Data for AMGT are not needed for carrots and bulb onions because these crops are either root or bulb vegetables.

For carrots and the commodities of the Bulb onion subgroup (3-07B), the recommended tolerance was used in both the acute and chronic assessments.  For head and leaf lettuce, an upper-bound ratio of 0.35:1 (AMGT:fluazinam) was used to estimate the AMGT residue.  This factor is the maximum AMGT:fluazinam ratio in grapes in the grape metabolism study.  The values obtained using this ratio were used in both the acute and chronic assessments.  In the apple field trials, both fluazinam and AMGT were measured.  The fluazinam tolerance is 2.0 ppm and the highest combined (fluazinam + AMGT) residue is 1.69 ppm.  The tolerance was used in the acute assessment and the average combined (fluazinam + AMGT) residue value of 0.215 ppm was used in the chronic assessment.  For an explanation of the factors used for previously registered plant commodities, see the last dietary exposure assessment that was performed for fluazinam (Memo, D340854, M. Doherty, 8/1/2007).

In animal commodities, the residues of concern for risk assessment are parent fluazinam and its metabolites AMPA and DAPA.  A residue value of 0.02 ppm is being used for meat byproducts and fat of cattle, goats, horses, and sheep (Memo, D360840, D. Dotson, x/x/2010).  This value is a very conservative one that accounts for all residues of concern in meat byproducts and fat.

The assessments were based on DEEM 7.81 default processing factors for processed commodities.  A full listing of the residue inputs used in the analyses is included as Attachments 1 and 3.

Table 1.  Summary of New-Use Food Crop Residue Levels Used in the Acute and Chronic

               Dietary Exposure Analyses

Crop/Crop Group	Tolerance Level

(ppm)	Residue Level for Dietary Exposure Assessment

(ppm)

Apples (Acute Assessment)	2.0	2.0 (tolerance)

Apples (Chronic Assessment)	2.0	0.215 (avg combined (fluazinam + AMGT) residue)

Carrots	0.70	0.7* (tolerance)

Bulb Onions (Subgroup 3-07A)	0.20	0.20* (tolerance)

Head Lettuce	0.02	0.027 (0.02 tolerance x 1.35)

Leaf Lettuce	2.0	2.7 (2.0 tolerance x 1.35)

*AMGT is not a significant residue in root and tuber crops or in bulb vegetables, so no correction is necessary for risk assessment

III.   Percent Crop Treated Information

The acute and chronic assessments were both based on the assumption that 100% of all commodities with fluazinam tolerances will be treated.

IV.   Drinking Water Data

The drinking water residue used in the dietary risk assessment was provided by the Environmental Fate and Effects Division (EFED; D360713, J. Meléndez, 2/24/2010) and incorporated directly into this dietary assessment into the food categories “water, direct, all sources” and “water, indirect, all sources.”  The residues of concern in drinking water for risk assessment are parent fluazinam and its transformation products, including DCPA, CAPA, DAPA and HYPA.  The estimated acute and chronic drinking water concentrations (EDWC) are based on ground application of fluazinam to apples.  The values are provided in Table 2, below.  The groundwater value was generated using the Screening Concentration in Groundwater (SCI-GROW) Model and the surface water values were generated using the FQPA Index Reservoir Screening Tool (FIRST) Model.  The surface water estimates were used for both the acute and chronic assessments because they were higher than the groundwater value.  For the acute assessment, a value of 117 ppb was used.  This value includes both parent and degradates.  For the chronic assessment, a value of 19.8 ppb was used.  This value also includes both parent and degradates.  For more information about EFED’s drinking water models, see   HYPERLINK "http://www.epa.gov/oppefed1/models/water/"  http://www.epa.gov/oppefed1/models/water/ ).

Table 2.  Maximum Tier I Estimated Drinking Water Concentrations

Drinking Water Source (Model Used) 	USE (Rate Modeled)	Maximum Estimated Drinking Water Concentration  (EDWC; ppb)

Groundwater

(SCI-GROW) Total Residues of Fluazinam (including parent)	Apples

(4.5 lb a.i./A/season)	Acute and Chronic	0.216

Surface Water

DEEM-FCID™ Program and Consumption Information

Fluazinam acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEM-FCID™,Version 2.03 which incorporates consumption data from USDA’s Continuing Surveys of Food Intakes by Individuals (CSFII), 1994-1996 and 1998.  The 1994-96, 98 data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days.  Foods “as consumed” (e.g., apple pie) are linked to EPA-defined food commodities (e.g. apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA.  For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups, but for acute exposure assessment are retained as individual consumption events.  Based on analysis of the 1994-96, 98 CSFII consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+ years old.

For chronic dietary exposure assessment, an estimate of the residue level in each food or food-form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form to produce a residue intake estimate.  The resulting residue intake estimate for each food/food form is summed with the residue intake estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure.  Exposure is expressed in mg/kg body weight/day and as a percent of the cPAD.  This procedure is performed for each population subgroup.

For acute exposure assessments, individual one-day food consumption data are used on an individual-by-individual basis.  The reported consumption amounts of each food item can be multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic exposure assessment, or “matched” in multiple random pairings with residue values and then summed in a probabilistic assessment.  The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i.e., only those who reported eating relevant commodities/food forms) and a per-capita (i.e., those who reported eating the relevant commodities as well as those who did not) basis.  In accordance with HED policy, per capita exposure and risk are reported for all tiers of analysis.  However, for tiers 1 and 2, any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment.

VI.   Toxicological Information

Adequate toxicological data have been submitted to permit assessment of fluazinam.  The data show that the primary target organ for chronic exposure to fluazinam is the liver.  Acute neurotoxicity was seen in rats and developmental toxicity was seen in rabbits.  As a result, both acute and chronic dietary assessments are appropriate.  The data also support reducing the FQPA Safety Factor to 1x.  Based on the available information, a dietary assessment of cancer risk is not necessary.  Detailed toxicological considerations can be found in the human health risk assessment for fluazinam (Memo, D371444, D. Dotson, 3/x/2010).  The fluazinam doses and endpoints for dietary exposure assessments are summarized in Table 3.

Table 3.  Toxicological Doses and Endpoints for Fluazinam for Use in Dietary Risk Assessments

Exposure/

Scenario	Point of Departure	Uncertainty/

FQPA Safety Factors	RfD, PAD, Level of Concern for Risk Assessment	Study and Toxicological Effects

Acute Dietary (General population)	NOAEL= 50 mg/kg/day

	UFA= 10x

UFH=10x

FQPA SF=1x

Total UF=100x	Acute RfD =0.5 mg/kg/day

aPAD

= 0.5mg/kg/day	Acute Neurotoxicity-Rats.

LOAEL = 1000 mg/kg/day based on decreased motor activity and soft stools on day of dosing.

Acute Dietary

(Females 13-49 years of age)	NOAEL (developmental) = 7 mg/kg/day	UFA= 10x

UFH=10x

FQPA SF=1x

Total UF=100x	Acute RfD =0.07 mg/kg/day

aPAD

= 0.07mg/kg/day	Developmental Toxicity- Rabbits.

Developmental LOAEL = 12  mg/kg/day based on increased incidence of total litter resorptions and possible increased incidence of fetal skeletal abnormalities.

Chronic Dietary (All Populations)	NOAEL= 1.1 mg/kg/day

	UFA= 10x

UFH=10x

FQPA SF=1x

Total UF=100x	Chronic RfD =0.011 mg/kg/day

cPAD

= 0.011mg/kg/day	Carcinogenicity-Mice.

LOAEL = 10.7 mg/kg/day based on liver histopathology and increased liver weight.

Cancer (oral, dermal, inhalation)	Classification: “Suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic potential.”  The cRfD is protective of cancer effects.

Point of Departure (PoD) = A data point or an estimated point that is derived from observed dose-response data and  used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures.  NOAEL = no observed adverse effect level.  LOAEL = lowest observed adverse effect level.  UF = uncertainty factor.  UFA = extrapolation from animal to human (interspecies).  UFH = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor.  PAD = population adjusted dose (a = acute, c = chronic).  RfD = reference dose. N/A = not applicable.

  TC \l3 "3.5.10	Classification of Carcinogenic Potential

VII.   Results/Discussion

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD.  The DEEM-FCID™ analyses estimate the dietary exposure of the U.S. population and various population subgroups.  The results reported in Table 4 are for the general U.S. Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49, adults 20-49, and adults 50+ years.  Risk estimates are below HED’s level of concern for all population subgroups in both the acute and chronic analyses.  The acute risk estimate for the general U.S. population is 4.1% of the acute PAD (aPAD).  The most highly exposed population subgroup is Females 13-49, which uses 20% of the aPAD.  The chronic risk estimate for the general U.S. population is 14% of the chronic PAD (cPAD).  The most highly exposed population subgroup is All Infants (<1 year old), which uses 40% of the cPAD.

The CARC determined that the cRfD is protective of cancer effects.  As the %cPAD for the general population (14%) is less than 100%, cancer risk is also not of concern.

Full listings of exposure and risk estimates are included in Attachments 2 (acute analysis) and 4 (chronic analysis).

Table 4.  Summary of Acute and Chronic Exposure and Risk Estimates for Fluazinam

Population Subgroup	Acute Assessment (95th Percentile)	Chronic Assessment

	aPAD, mg/day	Exposure Estimate, mg/day	% aPad	cPAD, mg/day	Exposure Estimate, mg/day	% cPad

U.S. Population	0.5	0.020332	4.1	0.011	0.001530	14

All infants	0.5	0.086600	17	0.011	0.004411	40

Children 1-2 yrs	0.5	0.098940	20	0.011	0.004064	37

Children 3-5 yrs	0.5	0.063647	13	0.011	0.002789	25

Children 6-12 yrs	0.5	0.022625	4.5	0.011	0.001374	13

Youth 13-19 yrs	0.5	0.013076	2.6	0.011	0.000813	7.4

Adults 20-49 yrs	0.5	0.012952	2.6	0.011	0.001346	12

Adults 50+ yrs	0.5	0.012761	2.6	0.011	0.001488	14

Females 13-49 yrs	0.07	0.014124	20	0.011	0.001394	13

VIII.   Characterization of Inputs/Outputs

HED considers both the acute and chronic assessments to be very conservative.  The acute assessment is based on tolerance-level residues for all commodities, with worst-case assumptions being made concerning residue levels of the metabolite AMGT.  In addition, it was assumed that 100% of all crops with registered or requested uses of fluazinam will be treated.  The EDWCs include parent fluazinam and its transformation products.  These same assumptions and inputs were used for the chronic assessment, except that an average field trial value was used for apples.  These assumptions result in highly conservative, health-protective estimates of exposure and risk.

IX.   Conclusions

The exposure estimates generated by the dietary exposure model that was used are likely to be overestimates of actual dietary exposures that might occur.  The aggregate (food + water) dietary risk estimates are below HED’s level of concern for all population subgroups for both the acute and chronic exposure scenarios.

X.   List of Attachments

Attachment 1.  Acute Dietary Residue Input File for Fluazinam.

Attachment 2.  Results of Acute Dietary Exposure Assessment

Attachment 3.  Chronic Dietary Residue Input File for Fluazinam

Attachment 4.  Results of Chronic Dietary Exposure Assessment

cc:  D. Dotson

Attachment 1:  Acute Dietary Residue Input File for Fluazinam

DEEM FCID Version 2.03

Acute NOAEL for general population including infants and children:  50 mg/kg bw/day

Acute PAD for general population including infants and children:  0.5 mg/kg bw/day

Acute NOAEL for Females 13-49:  7 mg/kg bw/day

Acute PAD for Females 13-49:  0.07 mg/kg bw/day

Filename: C:\Documents and Settings\ddotson\My Documents\Deemfcid\Fluazinam\

                 FluazinamAcuteRev3.R98

Date created/last modified: 03-15-2010/13:48:15/8

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2

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

01010780 1AB  Carrot                             0.700000   1.000  1.000

01010781 1AB  Carrot-babyfood                    0.700000   1.000  1.000

01010790 1AB  Carrot, juice                      0.700000   1.000  1.000

01011680 1AB  Ginseng, dried                     4.500000   1.000  1.000

01032960 1C   Potato, chips                      0.020000   1.000  1.000

01032970 1C   Potato, dry (granules/ flakes)     0.020000   6.500  1.000

01032971 1C   Potato, dry (granules/ flakes)-b   0.020000   6.500  1.000

01032980 1C   Potato, flour                      0.020000   6.500  1.000

01032981 1C   Potato, flour-babyfood             0.020000   6.500  1.000

01032990 1C   Potato, tuber, w/peel              0.020000   1.000  1.000

01032991 1C   Potato, tuber, w/peel-babyfood     0.020000   1.000  1.000

01033000 1C   Potato, tuber, w/o peel            0.020000   1.000  1.000

01033001 1C   Potato, tuber, w/o peel-babyfood   0.020000   1.000  1.000

03001640 3    Garlic                             0.200000   1.000  1.000

03001650 3    Garlic, dried                      0.200000   1.000  1.000

03001651 3    Garlic, dried-babyfood             0.200000   1.000  1.000

03002370 3    Onion, dry bulb                    0.200000   1.000  1.000

03002371 3    Onion, dry bulb-babyfood           0.200000   1.000  1.000

03002380 3    Onion, dry bulb, dried             0.200000   9.000  1.000

03002381 3    Onion, dry bulb, dried-babyfood    0.200000   9.000  1.000

03003380 3    Shallot                            0.200000   1.000  1.000

04012040 4A   Lettuce, head                      0.027000   1.000  1.000

04012050 4A   Lettuce, leaf                      2.700000   1.000  1.000

05010610 5A   Broccoli                           0.013500   1.000  1.000

05010611 5A   Broccoli-babyfood                  0.013500   1.000  1.000

05010620 5A   Broccoli, Chinese                  0.013500   1.000  1.000

05010640 5A   Brussels sprouts                   0.013500   1.000  1.000

05010690 5A   Cabbage                            0.013500   1.000  1.000

05010710 5A   Cabbage, Chinese, napa             0.013500   1.000  1.000

05010720 5A   Cabbage, Chinese, mustard          0.013500   1.000  1.000

05010830 5A   Cauliflower                        0.013500   1.000  1.000

05011960 5A   Kohlrabi                           0.013500   1.000  1.000

05020630 5B   Broccoli raab                      0.013500   1.000  1.000

05020700 5B   Cabbage, Chinese, bok choy         0.013500   1.000  1.000

05021170 5B   Collards                           0.013500   1.000  1.000

05021940 5B   Kale                               0.013500   1.000  1.000

05022290 5B   Mustard greens                     0.013500   1.000  1.000

05023180 5B   Rape greens                        0.013500   1.000  1.000

05023890 5B   Turnip, greens                     0.013500   1.000  1.000

06010430 6A   Bean, snap, succulent              0.135000   1.000  1.000

06010431 6A   Bean, snap, succulent-babyfood     0.135000   1.000  1.000

06012570 6A   Pea, edible podded, succulent      0.135000   1.000  1.000

06020310 6B   Bean, broad, succulent             0.054000   1.000  1.000

06020330 6B   Bean, cowpea, succulent            0.054000   1.000  1.000

06020370 6B   Bean, lima, succulent              0.054000   1.000  1.000

06022550 6B   Pea, succulent                     0.054000   1.000  1.000

06022551 6B   Pea, succulent-babyfood            0.054000   1.000  1.000

06022590 6B   Pea, pigeon, succulent             0.054000   1.000  1.000

06030300 6C   Bean, black, seed                  0.027000   1.000  1.000

06030320 6C   Bean, broad, seed                  0.027000   1.000  1.000

06030340 6C   Bean, cowpea, seed                 0.027000   1.000  1.000

06030350 6C   Bean,  great northern, seed        0.027000   1.000  1.000

06030360 6C   Bean, kidney, seed                 0.027000   1.000  1.000

06030380 6C   Bean, lima, seed                   0.027000   1.000  1.000

06030390 6C   Bean, mung, seed                   0.027000   1.000  1.000

06030400 6C   Bean, navy, seed                   0.027000   1.000  1.000

06030410 6C   Bean, pink, seed                   0.027000   1.000  1.000

06030420 6C   Bean, pinto, seed                  0.027000   1.000  1.000

06030980 6C   Chickpea, seed                     0.027000   1.000  1.000

06030981 6C   Chickpea, seed-babyfood            0.027000   1.000  1.000

06030990 6C   Chickpea, flour                    0.027000   1.000  1.000

06031820 6C   Guar, seed                         0.027000   1.000  1.000

06031821 6C   Guar, seed-babyfood                0.027000   1.000  1.000

06032030 6C   Lentil, seed                       0.027000   1.000  1.000

06032560 6C   Pea, dry                           0.027000   1.000  1.000

06032561 6C   Pea, dry-babyfood                  0.027000   1.000  1.000

06032580 6C   Pea, pigeon, seed                  0.027000   1.000  1.000

11000070 11   Apple, fruit with peel             2.000000   1.000  1.000

11000080 11   Apple, peeled fruit                2.000000   1.000  1.000

11000081 11   Apple, peeled fruit-babyfood       2.000000   1.000  1.000

11000090 11   Apple, dried                       2.000000   8.000  1.000

11000091 11   Apple, dried-babyfood              2.000000   8.000  1.000

11000100 11   Apple, juice                       2.000000   1.300  1.000

11000101 11   Apple, juice-babyfood              2.000000   1.300  1.000

11000110 11   Apple, sauce                       2.000000   1.000  1.000

11000111 11   Apple, sauce-babyfood              2.000000   1.000  1.000

13020570 13B  Blueberry                          7.800000   1.000  1.000

13020571 13B  Blueberry-babyfood                 7.800000   1.000  1.000

13021360 13B  Currant                            7.800000   1.000  1.000

13021370 13B  Currant, dried                     7.800000   1.000  1.000

13021490 13B  Elderberry                         7.800000   1.000  1.000

13021740 13B  Gooseberry                         7.800000   1.000  1.000

13021910 13B  Huckleberry                        7.800000   1.000  1.000

21000460 M    Beef, meat byproducts              0.050000   1.000  1.000

21000461 M    Beef, meat byproducts-babyfood     0.050000   1.000  1.000

21000470 M    Beef, fat                          0.050000   1.000  1.000

21000471 M    Beef,fat-babyfood                  0.050000   1.000  1.000

21000480 M    Beef, kidney                       0.050000   1.000  1.000

21000490 M    Beef, liver                        0.050000   1.000  1.000

21000491 M    Beef, liver-babyfood               0.050000   1.000  1.000

23001700 M    Goat, meat byproducts              0.050000   1.000  1.000

23001710 M    Goat, fat                          0.050000   1.000  1.000

23001720 M    Goat, kidney                       0.050000   1.000  1.000

23001730 M    Goat, liver                        0.050000   1.000  1.000

26003400 M    Sheep, meat byproducts             0.050000   1.000  1.000

26003410 M    Sheep, fat                         0.050000   1.000  1.000

26003411 M    Sheep, fat-babyfood                0.050000   1.000  1.000

26003420 M    Sheep, kidney                      0.050000   1.000  1.000

26003430 M    Sheep, liver                       0.050000   1.000  1.000

86010000 O    Water, direct, all sources         0.117000   1.000  1.000

86020000 O    Water, indirect, all sources       0.117000   1.000  1.000

95001790 O    Grape, wine and sherry             3.000000   1.000  1.000

95002630 O    Peanut                             0.020000   1.000  1.000

95002640 O    Peanut, butter                     0.020000   1.890  1.000

95002650 O    Peanut, oil                        0.020000   1.000  1.000

Attachment 2:  Results of Acute Dietary Exposure Assessment

Residue file: FluazinamAcuteRev2.R98

Analysis Date: 03-15-2010/13:48:15 (13:50:15 for Females 13-49)

Residue file dated: 03-15-2010/13:48:15/8

Daily totals for food and food form consumption used.

======================================================================== =======

Summary calculations (per capita):

                    95th Percentile      99th Percentile      99.9th Percentile

                   Exposure   % aRfD    Exposure   % aRfD    Exposure   % aRfD

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

U.S. Population:

                    0.020332     4.07    0.056560    11.31    0.137350    27.47

All infants:

                    0.086600    17.32    0.138084    27.62    0.428363    85.67

Children 1-2 yrs:

                    0.098940    19.79    0.166177    33.24    0.312424    62.48

Children 3-5 yrs:

                    0.063647    12.73    0.114181    22.84    0.193539    38.71

Children 6-12 yrs:

                    0.022625     4.53    0.054452    10.89    0.085714    17.14

Youth 13-19 yrs:

                    0.013076     2.62    0.029793     5.96    0.052066    10.41

Adults 20-49 yrs:

                    0.012952     2.59    0.024926     4.99    0.042089     8.42

Adults 50+ yrs:

                    0.012761     2.55    0.022255     4.45    0.040379     8.08

Females 13-49 yrs:

                    0.014124    20.18    0.027763    39.66    0.051897    74.14

Attachment 3:  Chronic Dietary Residue Input File for Fluazinam

DEEM FCID Version 2.03

Chronic NOAEL:  1.1 mg/kg bw/day

Chronic PAD:  0.011 mg/kg bw/day

Filename: C:\Documents and Settings\ddotson\My Documents\Deemfcid\Fluazinam\

                 FluazinamChronicRev3.R98

Date created/last modified: 03-15-2010/13:41:58/8

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2

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

01010780 1AB  Carrot                             0.700000   1.000  1.000

01010781 1AB  Carrot-babyfood                    0.700000   1.000  1.000

01010790 1AB  Carrot, juice                      0.700000   1.000  1.000

01011680 1AB  Ginseng, dried                     4.500000   1.000  1.000

01032960 1C   Potato, chips                      0.020000   1.000  1.000

01032970 1C   Potato, dry (granules/ flakes)     0.020000   6.500  1.000

01032971 1C   Potato, dry (granules/ flakes)-b   0.020000   6.500  1.000

01032980 1C   Potato, flour                      0.020000   6.500  1.000

01032981 1C   Potato, flour-babyfood             0.020000   6.500  1.000

01032990 1C   Potato, tuber, w/peel              0.020000   1.000  1.000

01032991 1C   Potato, tuber, w/peel-babyfood     0.020000   1.000  1.000

01033000 1C   Potato, tuber, w/o peel            0.020000   1.000  1.000

01033001 1C   Potato, tuber, w/o peel-babyfood   0.020000   1.000  1.000

03001640 3    Garlic                             0.200000   1.000  1.000

03001650 3    Garlic, dried                      0.200000   1.000  1.000

03001651 3    Garlic, dried-babyfood             0.200000   1.000  1.000

03002370 3    Onion, dry bulb                    0.200000   1.000  1.000

03002371 3    Onion, dry bulb-babyfood           0.200000   1.000  1.000

03002380 3    Onion, dry bulb, dried             0.200000   9.000  1.000

03002381 3    Onion, dry bulb, dried-babyfood    0.200000   9.000  1.000

03003380 3    Shallot                            0.200000   1.000  1.000

04012040 4A   Lettuce, head                      0.027000   1.000  1.000

04012050 4A   Lettuce, leaf                      2.700000   1.000  1.000

05010610 5A   Broccoli                           0.013500   1.000  1.000

05010611 5A   Broccoli-babyfood                  0.013500   1.000  1.000

05010620 5A   Broccoli, Chinese                  0.013500   1.000  1.000

05010640 5A   Brussels sprouts                   0.013500   1.000  1.000

05010690 5A   Cabbage                            0.013500   1.000  1.000

05010710 5A   Cabbage, Chinese, napa             0.013500   1.000  1.000

05010720 5A   Cabbage, Chinese, mustard          0.013500   1.000  1.000

05010830 5A   Cauliflower                        0.013500   1.000  1.000

05011960 5A   Kohlrabi                           0.013500   1.000  1.000

05020630 5B   Broccoli raab                      0.013500   1.000  1.000

05020700 5B   Cabbage, Chinese, bok choy         0.013500   1.000  1.000

05021170 5B   Collards                           0.013500   1.000  1.000

05021940 5B   Kale                               0.013500   1.000  1.000

05022290 5B   Mustard greens                     0.013500   1.000  1.000

05023180 5B   Rape greens                        0.013500   1.000  1.000

05023890 5B   Turnip, greens                     0.013500   1.000  1.000

06010430 6A   Bean, snap, succulent              0.135000   1.000  1.000

06010431 6A   Bean, snap, succulent-babyfood     0.135000   1.000  1.000

06012570 6A   Pea, edible podded, succulent      0.135000   1.000  1.000

06020310 6B   Bean, broad, succulent             0.054000   1.000  1.000

06020330 6B   Bean, cowpea, succulent            0.054000   1.000  1.000

06020370 6B   Bean, lima, succulent              0.054000   1.000  1.000

06022550 6B   Pea, succulent                     0.054000   1.000  1.000

06022551 6B   Pea, succulent-babyfood            0.054000   1.000  1.000

06022590 6B   Pea, pigeon, succulent             0.054000   1.000  1.000

06030300 6C   Bean, black, seed                  0.027000   1.000  1.000

06030320 6C   Bean, broad, seed                  0.027000   1.000  1.000

06030340 6C   Bean, cowpea, seed                 0.027000   1.000  1.000

06030350 6C   Bean,  great northern, seed        0.027000   1.000  1.000

06030360 6C   Bean, kidney, seed                 0.027000   1.000  1.000

06030380 6C   Bean, lima, seed                   0.027000   1.000  1.000

06030390 6C   Bean, mung, seed                   0.027000   1.000  1.000

06030400 6C   Bean, navy, seed                   0.027000   1.000  1.000

06030410 6C   Bean, pink, seed                   0.027000   1.000  1.000

06030420 6C   Bean, pinto, seed                  0.027000   1.000  1.000

06030980 6C   Chickpea, seed                     0.027000   1.000  1.000

06030981 6C   Chickpea, seed-babyfood            0.027000   1.000  1.000

06030990 6C   Chickpea, flour                    0.027000   1.000  1.000

06031820 6C   Guar, seed                         0.027000   1.000  1.000

06031821 6C   Guar, seed-babyfood                0.027000   1.000  1.000

06032030 6C   Lentil, seed                       0.027000   1.000  1.000

06032560 6C   Pea, dry                           0.027000   1.000  1.000

06032561 6C   Pea, dry-babyfood                  0.027000   1.000  1.000

06032580 6C   Pea, pigeon, seed                  0.027000   1.000  1.000

11000070 11   Apple, fruit with peel             0.215000   1.000  1.000

11000080 11   Apple, peeled fruit                0.215000   1.000  1.000

11000081 11   Apple, peeled fruit-babyfood       0.215000   1.000  1.000

11000090 11   Apple, dried                       0.215000   8.000  1.000

11000091 11   Apple, dried-babyfood              0.215000   8.000  1.000

11000100 11   Apple, juice                       0.215000   1.300  1.000

11000101 11   Apple, juice-babyfood              0.215000   1.300  1.000

11000110 11   Apple, sauce                       0.215000   1.000  1.000

11000111 11   Apple, sauce-babyfood              0.215000   1.000  1.000

13020570 13B  Blueberry                          7.800000   1.000  1.000

13020571 13B  Blueberry-babyfood                 7.800000   1.000  1.000

13021360 13B  Currant                            7.800000   1.000  1.000

13021370 13B  Currant, dried                     7.800000   1.000  1.000

13021490 13B  Elderberry                         7.800000   1.000  1.000

13021740 13B  Gooseberry                         7.800000   1.000  1.000

13021910 13B  Huckleberry                        7.800000   1.000  1.000

21000460 M    Beef, meat byproducts              0.050000   1.000  1.000

21000461 M    Beef, meat byproducts-babyfood     0.050000   1.000  1.000

21000470 M    Beef, fat                          0.050000   1.000  1.000

21000471 M    Beef,fat-babyfood                  0.050000   1.000  1.000

21000480 M    Beef, kidney                       0.050000   1.000  1.000

21000490 M    Beef, liver                        0.050000   1.000  1.000

21000491 M    Beef, liver-babyfood               0.050000   1.000  1.000

23001700 M    Goat, meat byproducts              0.050000   1.000  1.000

23001710 M    Goat, fat                          0.050000   1.000  1.000

23001720 M    Goat, kidney                       0.050000   1.000  1.000

23001730 M    Goat, liver                        0.050000   1.000  1.000

26003400 M    Sheep, meat byproducts             0.050000   1.000  1.000

26003410 M    Sheep, fat                         0.050000   1.000  1.000

26003411 M    Sheep, fat-babyfood                0.050000   1.000  1.000

26003420 M    Sheep, kidney                      0.050000   1.000  1.000

26003430 M    Sheep, liver                       0.050000   1.000  1.000

86010000 O    Water, direct, all sources         0.019800   1.000  1.000

86020000 O    Water, indirect, all sources       0.019800   1.000  1.000

95001790 O    Grape, wine and sherry             3.000000   1.000  1.000

95002630 O    Peanut                             0.020000   1.000  1.000

95002640 O    Peanut, butter                     0.020000   1.890  1.000

95002650 O    Peanut, oil                        0.020000   1.000  1.000

Attachment 4:  Results of Chronic Dietary Exposure Assessment

Residue file name: C:\Documents and Settings\ddotson\My Documents\Deemfcid\Fluazinam\

                               FluazinamChronicRev3.R98

Residue file dated: 03-15-2010/13:41:58/8

Analysis Date 03-15-2010/13:51:29

======================================================================== =======

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

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

U.S. Population (total)                     0.001530                13.9%

U.S. Population (spring season)             0.001483                13.5%

U.S. Population (summer season)             0.001563                14.2%

U.S. Population (autumn season)             0.001553                14.1%

U.S. Population (winter season)             0.001518                13.8%

Northeast region                            0.001699                15.4%

Midwest region                              0.001413                12.8%

Southern region                             0.001306                11.9%

Western region                              0.001859                16.9%

Hispanics                                   0.001378                12.5%

Non-hispanic whites                         0.001636                14.9%

Non-hispanic blacks                         0.001048                 9.5%

Non-hisp/non-white/non-black                0.001532                13.9%

All infants (< 1 year)                      0.004411                40.1%

Nursing infants                             0.002420                22.0%

Non-nursing infants                         0.005167                47.0%

Children 1-6  yrs                           0.003082                28.0%

Children 7-12 yrs                           0.001261                11.5%

Females 13-19 (not preg or nursing)         0.000812                 7.4%

Females 20+ (not preg or nursing)           0.001544                14.0%

Females 13-50 yrs                           0.001415                12.9%

Females 13+ (preg/not nursing)              0.001169                10.6%

Females 13+ (nursing)                       0.001183                10.8%

Males 13-19 yrs                             0.000808                 7.3%

Males 20+ yrs                               0.001250                11.4%

Seniors 55+                                 0.001512                13.7%

Children 1-2 yrs                            0.004064                36.9%

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Adults 20-49 yrs                            0.001346                12.2%

Adults 50+ yrs                              0.001488                13.5%

Females 13-49 yrs                           0.001394                12.7%

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

Fluazinam 	Dietary Exposure and Risk Assessment	DP Number:  D374522

PC Code:  129098

 PAGE

Page   PAGE  2  of   NUMPAGES  16

DRAFT – Confidential, Internal, and Deliberative Material

[Chemical Name]	Dietary Exposure and Risk Assessment	DP Number: [xxxxxxx]

PC Code:  [xxxxxx]


[Federal Register Volume 87, Number 118 (Tuesday, June 21, 2022)]
[Notices]
[Pages 36859-36861]
[FR Doc No: 2022-13212]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0737]

Non-Clinical Performance Assessment of Tissue Containment Systems
Used During Power Morcellation Procedures; Draft Guidance for Industry
and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Non-Clinical
Performance Assessment of Tissue Containment Systems Used During Power
Morcellation Procedures.'' This draft guidance document provides
recommendations that may help manufacturers comply with the special
controls related to non-clinical performance data for gynecologic and
general laparoscopic power morcellation containment systems. This draft
guidance is not final nor is it for implementation at this time.

DATES: Submit either electronic or written comments on the draft
guidance by August 22, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time 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-2022-D-0737 for ``Non-Clinical Performance Assessment of Tissue
Containment Systems Used During Power Morcellation Procedures.''
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,<PHONE_NUMBER>.
     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.govinfo.gov/content/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,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Non-Clinical Performance Assessment of Tissue Containment Systems
Used During Power Morcellation Procedures'' to the Office of Policy,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Prasanna Hariharan, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 62, Rm. 2222, Silver Spring, MD 20993-0002, 301-
796-2689.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is issuing this draft guidance to provide recommendations that
may help manufacturers comply with the special controls related to non-
clinical performance data for gynecologic and general laparoscopic
power morcellation containment systems. These devices are class II
(special controls) devices and subject to premarket notification
(510(k)) requirements. These tissue containment systems are
prescription devices consisting of an instrument port and tissue
containment method that create a working space allowing for direct
visualization during a power morcellation procedure following a
laparoscopic procedure for the excision of benign tissue that is not
suspected to contain malignancy.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on the topic of
the guidance. It does not establish any rights for any person and is
not binding on FDA or the public. You can use an alternative approach
if it satisfies the requirements of the applicable statutes and
regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov or https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to
download an electronic copy of ``Non-Clinical Performance Assessment of
Tissue Containment Systems Used During Power Morcellation Procedures''
may send an email request to [email protected] to receive an
electronic copy of the document. Please use the document number 19015
and complete title to identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by

OMB under the PRA. The collections of information in the following FDA
regulation and guidance have been approved by OMB as listed in the
following table:

------------------------------------------------------------------------
                                                            OMB control
      21 CFR part or guidance               Topic               No.
------------------------------------------------------------------------
807, subpart E....................  Premarket                  0910-0120
                                     notification.
``Requests for Feedback and         Q-submissions.......       0910-0756
 Meetings for Medical Device
 Submissions: The Q-Submission
 Program''.
------------------------------------------------------------------------

    Dated: June 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13212 Filed 6-17-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: January 18, 2011 (Volume 76, Number 11)]
[Notices]
[Page 2893-2894]
[DOCID:fr18ja11-43]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 5637-005]

Bell Mountain Hydro LLC; Notice of Application for Amendment of
Exemption and Soliciting Comments, Motions To Intervene, and Protests

January 11, 2011.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Amendment of Exemption.
    b. Project No.: 5637-005.
    c. Date Filed: November 22, 2010.
    d. Applicant: Bell Mountain Hydro, LLC.
    e. Name of Project: Pancheri Hydroelectric Project.
    f. Location of Project: On the Telford Irrigation Pipeline, in
Butte County, Idaho.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Mr. Ted Sorenson, Bell Mountain Hydro LLC,
5203 South 11th East, Idaho Falls, ID 83404;<PHONE_NUMBER>.
    i. FERC Contact: Mr. Christopher Chaney,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and protest:
February 10, 2011.
    All documents may be filed electronically via the Internet. See, 18
CFR 385.2001(a)(1)(iii) or the instructions on the Commission's Web
site at http://www.ferc.gov/docs-filing/efiling.asp. If unable to be
filed electronically, documents may be paper-filed. To paper-file, an
original and seven copies should be mailed to: The Secretary, Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426. Commenters may submit comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/
docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments.
    The Commission's Rules of Practice and Procedure require all
interveners filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervener files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency.
    k. Description of Request: Bell Mountain Hydro, LLC is seeking an
amendment to reflect the transmission line configuration as it was
originally built in 1982. The original exemption authorized the
construction of a 7,000-foot-long transmission line extending in a
south-southeast direction from the powerhouse. However, the original
line, as-built in 1982, is approximately 5,830 feet in length and
extends from the powerhouse toward the south-southwest. The amendment
does not propose any new construction or modifications to project
facilities or changes in project operation.
    l. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support. A copy is also available for inspection and
reproduction at the address in item h above.
    You may also register online at http://www.ferc.gov/docs-filing/
esubscription.asp to be notified via e-mail of new filings and
issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    Anyone may submit comments, a protest, or a motion to intervene in
accordance with the requirements of Rules of Practice and Procedure, 18
CFR 385.210, .211, .214. In determining the appropriate action to take,
the Commission will consider all protests or other comments filed, but
only those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    Any filings must bear in all capital letters the title
``COMMENTS,'' ``PROTEST,'' or ``MOTION TO INTERVENE,'' as applicable,
and the Project Number of the particular application to which the
filing refers. A copy of any motion to intervene must also be served
upon each representative of the Applicant specified in the particular
application.
    Federal, State, and local agencies are invited to file comments on
the described application. A copy of the application may be obtained by
agencies directly from the applicant. If an agency does not file
comments within the time specified for filing comments, it will be
presumed to have no comments. One copy of an agency's comments must
also

be sent to the Applicant's representatives.

Kimberly D. Bose,
Secretary.
[FR Doc. 2011-914 Filed 1-14-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 56 (Wednesday, March 23, 2016)]
[Proposed Rules]
[Pages 15489-15491]
[FR Doc No: 2016-06521]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket Number USCG-2016-0141]
RIN 1625-AA08

Special Local Regulation; Space Coast Super Boat Grand Prix;
Atlantic Ocean, Cocoa Beach, FL

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes to establish a special local
regulation on the waters of the Atlantic Ocean offshore from Cocoa
Beach, FL during the Space Coast Super Boat Grand Prix, a series of
high-speed boat races. This action is necessary to provide for the
safety of life on the navigable waters surrounding the event. This
special local regulation will be enforced from 10 a.m. to 5 p.m. on May
15, 2016. This proposed rulemaking would prohibit persons and vessels
from being in the regulated area unless authorized by the Captain of
the Port (COTP) Jacksonville or a designated representative. We invite
your comments on this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before April 22, 2016.

ADDRESSES: You may submit comments identified by docket number USCG-
2016-0141 using the Federal eRulemaking Portal at http://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email Lieutenant Allan Storm, Sector
Jacksonville, Waterways Management Division, U.S. Coast Guard;
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    On January 30, 2016, Super Boat International Productions, Inc.
notified the Coast Guard that it will be conducting a series of high
speed boat races in the Atlantic Ocean, offshore from Cocoa Beach, FL
on May 15, 2016 from 10 a.m. to 5 p.m. The COTP Jacksonville has
determined that the potential hazards associated with high speed boat
races necessitate the establishment of a special local regulation.
    The purpose of this rulemaking is to ensure the safety of life on
the navigable waters of the United States by prohibiting all vessels
and persons not participating in the event from entering the regulated
area. The Coast Guard proposes this rulemaking under authority in 33
U.S.C. 1233.

III. Discussion of Proposed Rule

    The COTP proposes to establish a special local regulation for the
Space Coast Super Boat Grand Prix, a series of high-speed boat races.
The regulated area includes the waters of the Atlantic Ocean offshore
from Cocoa Beach, Florida and will be enforced daily from 10 a.m. to 5
p.m., on May 15, 2016. Approximately 30 high-speed boats are
anticipated to participate in the races. The regulated area would
encompass an offshore area that is approximately two and a half
nautical miles long by a half nautical mile wide. No vessel or person
would be permitted to enter the regulated area without obtaining
permission from the COTP or a designated representative. The regulatory
text we are proposing appears at the end of this document.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes and Executive orders and
we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility. This NPRM has not been designated
a ``significant regulatory action,'' under Executive Order 12866.
Accordingly, the NPRM has not been reviewed by the Office of Management
and Budget.
    The Coast Guard has determined that this NPRM is not a significant
regulatory action for the following reasons: (1) The special local
regulation would be enforced for a total of only seven hours; (2)
although persons and vessels would not be able to enter, transit
through, anchor in, or remain within the regulated area without
authorization from the COTP Jacksonville or a designated
representative, they would be able to operate in the surrounding area
during the enforcement period; (3) persons and vessels would still be
able to enter, transit through, anchor in, or remain within the
regulated area if authorized by the COTP Jacksonville or a designated
representative; and (4) the Coast Guard would provide advance
notification of the special local regulation to the local maritime
community via Broadcast Notice to Mariners or by on-scene designated
representative.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit
through the regulated area may be small entities, for the reasons
stated in section IV.A above, this proposed rule would not have a
significant economic impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement

Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section. The Coast Guard will not retaliate against small entities that
question or complain about this proposed rule or any policy or action
of the Coast Guard.

C. Collection of Information

    This proposed rule would not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this proposed rule has implications for federalism or
Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule involves a special
local regulation that would prohibit persons and vessels from
transiting through an offshore area that is approximately two and a
half nautical miles long by a half nautical mile wide during a one day
racing event lasting seven hours. Normally such actions are
categorically excluded from further review under paragraph 34(h) of
Figure 2-1 of Commandant Instruction M16475.lD. A preliminary
environmental analysis checklist and Categorical Exclusion
Determination are available in the docket where indicated under
ADDRESSES. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this proposed
rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places, or vessels.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).
    Documents mentioned in this NPRM as being available in the docket,
and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that Web site's
instructions. Additionally, if you go to the online docket and sign up
for email alerts, you will be notified when comments are posted or a
final rule is published.

List of Subjects in 33 CFR Part 100

    Marine safety, Navigation (water), Reporting and recordkeeping
requirements, Waterways.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority: 33 U.S.C. 1233.

0
2. Add Sec.  100.35T07-0141 to read as follows:

Sec.  100.35T07-0141  Special Local Regulation, Space Coast Super Boat
Grand Prix; Atlantic Ocean, Cocoa Beach, FL.

    (a) Regulated area. The following regulated area is a special local
regulation located offshore from Cocoa Beach, FL. All waters of the
Atlantic Ocean encompassed within the following points: Starting at
Point 1 in position 28[deg]22'16'' N., 80[deg]36'04'' W.; thence east
to Point 2 in position 28[deg]22'15'' N., 80[deg]35'39'' W.; thence
south to Point 3 in position 28[deg]19'47'' N., 80[deg]35'55'' W.;
thence west to Point 4 in position 28[deg]19'47'' N., 80[deg]36'22''
W.; thence north back to origin. These coordinates are based on North
American Datum 1983.
    (b) Definition. The term ``designated representative'' means Coast
Guard Patrol Commanders, including Coast Guard coxswains, petty
officers, and other officers operating Coast Guard vessels, and
Federal, state, and local officers designated by or assisting the
Captain of the Port (COTP) Jacksonville in the enforcement of the
regulated area.
    (c) Regulations. (1) All persons and vessels are prohibited from
entering, transiting through, anchoring in, or

remaining within the regulated area unless authorized by the COTP
Jacksonville or a designated representative.
    (2) Persons and vessels desiring to enter, transit through, anchor
in, or remain within the regulated area may contact the COTP
Jacksonville by telephone at<PHONE_NUMBER>, or a designated
representative via VHF-FM radio on channel 16 to request authorization.
If authorization is granted, all persons and vessels receiving such
authorization must comply with the instructions of the COTP
Jacksonville or designated representative.
    (3) The Coast Guard will provide notice of the regulated area
through Broadcast Notice to Mariners via VHF-FM channel 16 or by on-
scene designated representatives.
    (d) Enforcement period. This section will be enforced from 10 a.m.
to 5 p.m. on May 15, 2016.

    Dated: March 14, 2016.
J.F. Dixon,
Captain, U.S. Coast Guard, Captain of the Port Jacksonville.
[FR Doc. 2016-06521 Filed 3-22-16; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 82, Number 22 (Friday, February 3, 2017)]
[Notices]
[Pages 9206-9207]
[FR Doc No: 2017-02289]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2503-161]

Duke Energy Carolinas, LLC; Notice of Application Accepted for
Filing and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Recreation Management Plan.
    b. Project No: 2503-161.
    c. Date Filed: November 14, 2016.
    d. Applicant: Duke Energy Carolinas, LLC.
    e. Name of Project: Keowee-Toxaway Hydroelectric Project.
    f. Location: The project is located on the Toxaway, Keowee, and
Little Rivers in Transylvania County, North Carolina, and Oconee and
Pickens counties, South Carolina.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: John Crutchfield, Duke Energy Carolinas, LLC,
526 S. Church Street, Charlotte, NC 28202,<PHONE_NUMBER>.
    i. FERC Contact: Kevin Anderson,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and
protests: March 1, 2017.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>(866) 208-3676 (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, please
send a paper copy to: Secretary, Federal Energy Regulatory Commission,
888 First Street NE., Washington, DC 20426.

The first page of any filing should include docket number P-2503-161.
Comments emailed to Commission staff are not considered part of the
Commission record.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency.
    k. Description of Request: The licensee filed for Commission
approval a revised recreation management plan pursuant to Article 406
of the license order issued August 16, 2016. The revised plan includes
provisions to operate, maintain, and construct recreation facilities at
specific recreation sites, monitor the capacity and condition of the
Warpath Access Area, and stabilize 6,250 linear feet of shoreline on
islands in Lake Keowee. The revised plan also includes an updated
implementation schedule.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. You may also
register online at http://www.ferc.gov/docs-filing/esubscription.asp to
be notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above. Agencies may obtain copies of the application directly from
the applicant.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214, respectively. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title ``COMMENTS'', ``PROTEST'', or ``MOTION TO
INTERVENE'' as applicable; (2) set forth in the heading the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person commenting, protesting or intervening; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis. Any filing made by an intervenor must be accompanied
by proof of service on all persons listed in the service list prepared
by the Commission in this proceeding, in accordance with 18 CFR
385.2010.

    Dated: January 30, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-02289 Filed 2-2-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 148 (Thursday, August 5, 2021)]
[Notices]
[Page 42870]
[FR Doc No: 2021-16760]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2021-0238]

Consolidation of Redundant Coast Guard Boat Stations; Extension
of Comment Period

AGENCY: Coast Guard, DHS.

ACTION: Extension of public comment period.

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

SUMMARY: The Coast Guard is extending the deadline for the submission
of public comments in response to its June 9, 2021 request for comments
regarding the consolidation of redundant Coast Guard boat stations.

DATES: The deadline for the request for comments published June 9,
2021, at 86 FR 30612, is extended. Public comments must be submitted no
later than 11:59 p.m. Eastern Time on September 22, 2021.

ADDRESSES: You may submit comments identified by docket number USCG-
2021-0238 using the Federal eRulemaking Portal at https://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section in the
original Request for Comments for further instructions on submitting
comments.

FOR FURTHER INFORMATION CONTACT: For information about this document
call or email Todd Aikins, Coast Guard Office of Boat Forces; telephone
202-372-2463, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On June 9, 2021, the Coast Guard published a
request for comments regarding the consolidation of certain redundant
Coast Guard boat stations. The Coast Guard solicited comments
specifically on the consolidation of Stations-Small Scituate, MA;
Holland, MI; North Superior, MN; and Beach Haven, NJ. The public
comment period was initially set to expire on August 3, 2021, but due
to the disruption caused by the global pandemic and requests by local
partners for additional time, the Coast Guard believes it would be
beneficial to extend the deadline for public comments to ensure the
Coast Guard has the benefit of a complete record. The Coast Guard is
therefore extending the deadline to submit public comments to no later
than 11:59 Eastern Time on September 22, 2021.
    This notice is issued under authority of 5 U.S.C. 552(a).

    Dated: August 2, 2021.
James B. Rush,
Captain, U.S. Coast Guard, Chief, Office of Boat Forces.
[FR Doc. 2021-16760 Filed 8-4-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 135 (Friday, July 13, 2012)]
[Notices]
[Pages 41399-41400]
[FR Doc No: 2012-17151]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER12-2145-000]

 EC&R O&M, LLC; Supplemental Notice That Initial Market-Based
Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
EC&R O&M, LLC's application for market-based rate authority, with an
accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR Part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR Part 34, of future issuances of securities and assumptions of
liability, is July 26, 2012.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also 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 email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call

(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: July 6, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-17151 Filed 7-12-12; 8:45 am]
BILLING CODE 6717-01-P