UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

								OFFICE OF

 PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date:  		July 23, 2009

SUBJECT:	Fenarimol.  Chronic Dietary (Food and Drinking Water) Exposure Assessment for the Petition Proposing Tolerances for Residues of Fenarimol on Hops.

PC Code:  	206600	DP Number:	331895

Decision No.:	367682	Registration No.:	10163-273

Petition No.:	6E7074	Regulatory Action:	Section 3

Assessment Type:	Dietary	Registration Case No.:	None

TXR No.:	None	CAS No.:	60168-88-9

MRID No.:	None	40 CFR:	§180.421

FROM:	Breann Hanson, Biologist

Alternative Risk Integration and Assessment (ARIA) Team

Risk Integration Minor Use and Emergency Response Branch 				 (RIMUERB)/Registration Division (RD; 7505P)

THROUGH:   William Cutchin, Acting Senior Branch Scientist

		ARIA Team

RIMERB/RD (7505P)

AND

Thurston Morton, Chemist

		Dietary Exposure Science Advisory Council (DESAC)

		Health Effects Division (HED; 7509P)

TO:		Breann Hanson, Biologist

ARIA Team

RIMUERB/RD (7505P)

	Daniel Rosenblatt /Barbara Madden/Susan Stanton

	RIMUERB/RD (7505P)

Executive Summary

The purpose of this memorandum is to report the results of a chronic dietary (food + drinking water) exposure analysis for the fungicide fenarimol, alpha-(2 chlorophenyl)-alpha-(4-chlorophenyl)-5-pyrimidinemethanol, on hops. In this analysis, the chronic dietary exposure and risk estimates resulting from food and water intake were determined for the general U.S. population and various population subgroups.

A chronic dietary risk assessment was 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.  This analysis was performed to support an Interregional Research Project No. 4 (IR-4) petition (PP#: 6E7074) proposing the use of Rubigan™ EC (EPA Reg. No. 10163-273), a 12 % emulsifiable concentrate liquid which contains 1.0 lb active ingredient (ai) per gallon, for control of powdery mildew on hops.

Additionally, in order to harmonize with a Codex Maximum Residue Limit (MRL) of 0.3 ppm for apples, EPA has proposed increasing the tolerance for residues of apples from 0.1 ppm to 0.3 ppm.  The Agency has determined that the increased tolerance is safe, i.e., there is a reasonable certainty that no harm will result from aggregate exposure (FR Notice: Volume 72, Number 108, 6/6/2007).

In calculating dietary risk estimates, ARIA has compared the chronic population-adjusted dose (cPAD) to the respective estimated dietary exposures.  Typically, ARIA has concerns regarding dietary risk when the estimates exceed 100% of the cPAD.

Drinking Water Contribution

The Environmental Fate and Effects Division (EFED) provided a drinking water assessment for fenarimol.  The assessment evaluated the maximum use patterns of the current uses on turf and ornamentals as they appear on the proposed labels.  Additionally, exposure was estimated for fenarimol use on turf that is restricted to professional stadia and golf course tees, greens, and fairways at the currently proposed application rates.  The resulting estimated drinking water concentrations (EDWCs) are noted in Table 2, below.  With the currently proposed use patterns, the 1-in-10-year annual mean EDWC is 226 ppb.  With the revised use patterns proposed by EFED, the exposure estimate is significantly reduced, resulting in a 1-in-10-year annual mean EDWC of 66 ppb.

 Acute Dietary (Food + Drinking Water) Exposure Results and Characterization

HED previously determined the doses and endpoints for use in human health risk assessments for fenarimol.  There was no appropriate endpoint for assessing acute dietary exposure; therefore, no acute dietary risk assessment was performed.

Chronic Dietary (Food + Drinking Water) Exposure Results and Characterization

The chronic dietary exposure assessment for fenarimol is highly refined using anticipated residues based on Food and Drug Administration (FDA) monitoring data for apples, bananas, cherries, grapes and pears.  Field trial residue data were used for pecans.  Percent crop treated (%CT) information and processing factors, where available, were used in the assessment. There were no PDP monitoring data available for fenarimol. The only registered uses of fenarimol in/on food/feed crops are apples, pears, cherries, pecans, hazelnuts and grapes.  Bananas were included in the assessment to account for imported bananas.

The chronic dietary risk assessment for fenarimol at the EDWC of 226 ppb showed that chronic dietary risk estimates are above ARIA’s level of concern (i.e. >100% chronic population adjusted doses (cPAD)) for infants (<1 year old), the highest exposed population subgroup (260% of the cPAD), as well as for children 1-2 years old (120% of the cPAD) and children 3-5 years old (110% of the cPAD).

At the EDWC of 66 ppb as a result of EFED’s proposed changes in the use pattern, the chronic dietary risk estimates are below ARIA’s level of concern (i.e. <100% chronic population adjusted doses (cPAD)) for infants (<1 year old), the highest exposed population subgroup (76% of the cPAD), as well as for the general US population (23% of the cPAD).

Cancer Exposure Results and Characterization

HED classified fenarimol as a “not likely to be carcinogenic to humans” based on the absence of significant tumor increases in two adequate rodent carcinogenicity studies; therefore, quantification of human cancer risk is not required.

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 ARIA 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, ARIA is concerned when estimated dietary risk exceeds 100% of the PAD.  ARIA is generally concerned when estimated cancer risk exceeds one in one million (i.e., the risk exceeds 1 x 10-6).  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,” 6/21/2000, 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 (8/20/99).

The most recent dietary risk assessment for fenarimol was conducted by HED (DP#: 278898, D. Drew, 11/19/2001), in conjunction with an anticipated residue analysis, to determine the chronic dietary risks associated with the re-registration of fenarimol.

II.	Residue Information

Tolerances:  Permanent tolerances are established for residues of fenarimol in/on a variety of commodities at levels ranging from 0.01 ppm in/on livestock meat, fat and kidneys to 1.0 ppm in/on cherries [40 CFR §180.421(a)].

Residue of Concern:  HED previously concluded that the residue of concern for both plants and livestock is fenarimol.  Although HED previously suggested that field trial studies on new crops include data for parent and metabolites (B &C), the registrant submitted data for only fenarimol-only on hops.

Recommended Tolerances:  As part of the current petition (PP#: 6E7074), ARIA recommends (DP#: 331894, D. Rate, 11/15/2006) for the tolerance, noted below, for residues of fenarimol under 40 CFR 180.421(a):

Hops	1.2 ppm

Residue Data Used for Chronic Assessment:  The DEEM-FCID( chronic analysis was performed using ARs from field trial data, processing factors and updated %CT information.

Anticipated Residues and Processing Factors:

Table 1.  Processing Factors Used in the Chronic Dietary Analysis for Fenarimol

Commodity	Data Used	Anticipated Residue (PPM)	Processing Factor

Apples

   juice

   dried	1996-1999 FDA Data for Apples	0.0015	1x

0.05x

8x

Bananas

   dried	1996-1999 FDA Data for Bananas	0.0045	1x

3.9x

Cherries

   juice

   dried	1996-1999 FDA Data for Cherries	0.0034	1x

1.5x

4x

Filberts	Field Trial Data

(MRID 43758901)	0.01	1x

Grapes

   juice

   raisin

   wine	1996-1999 FDA Data for Grapes	0.0060	1x

1.2x

1.6

1x

Pears

   juice

   dried	1996-1999 FDA Data for Pears	0.0015	1x

0.05x

6.25x

Pecans	Field Trial Data

(MRID 00145943)	0.0037	1x

Meat-lean (fat/free) w/o bones

Ruminant Feeding Study

(MRID 40098605)	0.00009	1x

Meat-fat w/o bones

0.0001	1x

Dried meat*

0.00009	1.92x

Meat byproducts*

0.0003	1x

Other organ meats*

0.0003	1x

Kidney*

0.0001	1x

* includes beef, sheep, goat and horse

The DEEM default processing factors were used for all food forms except apple juice, pear juice, grape juice, and raisins, for which the aforementioned factors derived from the processing studies were used.  Since the previous DEEM, tolerances on liver have been revoked since it is considered to be included in the meat byproducts tolerance.

Percent Crop Treated:  A Screening Level Usage Analysis (SLUA) for fenarinol was provided by BEAD based on data years 2001-2007 (DP#: 366920, A. Grube, 7/15/2009). The maximum percent crop treated (%CT) was used for estimating chronic dietary exposure.  Of the currently registered uses of fenarimol, wet apple pomace is the only commodity that is considered a livestock feed item; therefore, the maximum %CT for apples was used for livestock commodities.

Table 2. SLUA %CT Information

Crop	Max. %CT

Apples	20

Cabbage	< 2.5

Cherries	15

Grapes	25

Peaches	< 2.5

Pears	10

III.	Drinking Water Data

The drinking water residues used in the dietary risk assessment were provided by EFED (DP#: 363249, G. Orrick, 6/30/2009) and incorporated directly into this dietary assessment.  Water residues were incorporated in the DEEM-FCID into the food categories “water, direct, all sources” and “water, indirect, all sources.”   Because a previous dietary assessment run resulted in dietary risk exceedances, revisions to the current labels were submitted to the Agency.   The revised assessment evaluated the maximum use patterns of the current uses on turf and ornamentals as they appear on the proposed labels.  Additionally, exposure was estimated for fenarimol use on turf that is restricted to professional stadia and golf course tees, greens, and fairways at the currently proposed application rates.  Exposure estimates reflect total residues of concern that include fenarimol and its degradates of risk concern.

The Pesticide Root Zone Model (PRZM v3.12.2) and Exposure Analysis Modeling System (EXAMS v<IP_ADDRESS>) simulation models coupled with the input shell PE (v5.0) was used to generate EDWCs of fenarimol residues that may occur in surface water used as drinking water.  Screening Concentration in Ground Water (SCI-GROW v2.3) is a regression model used as a screening tool to estimate pesticide concentrations found in ground water used as drinking water.

The surface water EDWCs for the currently proposed use patterns are similar to those in the previous drinking water assessment (DP#: 330715; G. Orrick, 9/13/2007), as the maximum use pattern for turf has not changed with the exception that application is currently limited to ground equipment.   If turf uses of fenarimol are limited to professional stadia and golf course tees and greens at 11 lbs ai/A and to golf course fairways at 8.1 lbs ai/A, exposure estimates are reduced, resulting in a 1-in-10-year annual mean EDWC of 66 µg/L.  See Table 3, below.

Table 3.  Tier II Total Residue EDWCs in Surface Water and Ground Water from Currently and Potentially Proposed Labels for Current and Proposed Fenarimol Uses.

Source	Use (modeled rate)	1-in-10-year Peak Exposure (ppb)	1-in-10-year Annual Mean Exposure (ppb)	30-year Mean Exposure (ppb)

Current Use Pattern

Surface water	Turf (11 lbs ai/A/year)	283	226	154

Ground water

19	19	<19

EFED Proposed Use Pattern

Surface water

	Professional stadia, golf course tees and greens (at 11 lbs ai/A/year) and golf course fairways (at 8.1 lbs ai/A/year)	80	66	44

Ground water

19	19	<19

IV.	DEEM-FCID™ Program and Consumption Information

The fenarimol chronic dietary exposure assessment was 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, 1998 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, 1998 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.

V.	Toxicological Information

HED previously determined the doses and endpoints for use in human health risk assessments for fenarimol.  HED recently revised the FQPA safety factor (DP#: 331611, C. Swartz, 3/22/2007); the FQPA safety factor for fenarimol has been reduced to 1x for chronic dietary assessment.

No appropriate endpoint was available in the toxicological data base to estimate risk to the general population or for females (ages 13 to 50) from a single dose administration of fenarimol.  Therefore, an acute dietary exposure assessment need not be performed.  For chronic dietary exposure, the NOAEL is 0.6 mg/kg/day based on decreased litter size at 1.2 mg/kg/day (LOAEL) as determined from a 2-generation rat reproduction toxicity study.  HED classified fenarimol as “not likely to be carcinogenic to humans.” As such, a cancer dietary risk assessment is not warranted.

The doses relevant to dietary exposure are summarized in Table 4, below.

Table 4.  Summary of Toxicological Doses and Endpoints for Fenarimol 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 (All Populations)	N/A	N/A	N/A	No appropriate hazard was identified for single dose risk assessment.

Chronic Dietary (All Populations)	NOAEL= 0.6

mg/kg/day	UFA=10X

UFH=10X

FQPA SF=1X

	Chronic RfD =0.006

mg/kg/day

cPAD =0.006

mg/kg/day	Rat reproduction

LOAEL = 1.2 mg/kg/day Based on decreased liveborn litter size.

Cancer (oral, dermal, inhalation)	Classification:  “Not likely to be Carcinogenic to Humans” based on the absence of significant tumor increases in two adequate rodent carcinogenicity studies.

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.

VI.	Results/Discussion

As stated above, for chronic dietary assessments, ARIA is concerned when dietary risk exceeds 100% of the cPAD.  The DEEM-FCID( analyses estimate the dietary exposure of the US population and various population subgroups.  The results reported in Table 3 (below) are for the general US population (total), all infants <1, children 1-2, children 3-5, children 6-12, youths 13-19, females 13-49, adults 20-49, and adults 50+ years old for chronic exposure.

Results of Chronic Dietary Exposure Analysis:  The chronic dietary risk assessment for fenarimol at the EDWC of 226 ppb showed that chronic dietary risk estimates are above ARIA’s level of concern (i.e. >100% chronic population adjusted doses (cPAD)) for infants (<1 year old), the highest exposed population subgroup (260% of the cPAD), as well as for children 1-2 years old (120% of the cPAD) and children 3-5 years old (110% of the cPAD).

At the EDWC of 66 ppb as a result of EFED’s proposed changes in the use pattern, the chronic dietary risk estimates are below ARIA’s level of concern (i.e. <100% chronic population adjusted doses (cPAD)) for infants (<1 year old), the highest exposed population subgroup (76% of the cPAD), as well as for the general US population (23% of the cPAD).

The results of the chronic dietary exposure analyses are reported in the Summary Tables (Tables 5 and 6, below).

Table 5.  Summary of Dietary Exposure and Risk for Fenarimol with an EDWC of 226 ppb.

Population Subgroup1	DEEM Acute Dietary Analysis,

95th Percentile	DEEM Chronic Dietary Analysis

	Exposure (mg/kg/day)	% aPAD	Exposure (mg/kg/day)	% cPAD

General U.S. Population

NA 2

	0.004775	80

All Infants (< 1 year old)

0.015626	260

Children 1-2 years old

0.007088	120

Children 3-5 years old

0.006630	110

Children 6-12 years old

0.004571	76

Youth 13-19 years old

0.003448	58

Adults 20-49 years old

0.004464	74

Adults 50+ years old

0.004687	78

Females 13-49 years old

0.004436	74

1 Values for the population with the highest risk for each type of risk assessment are bolded.

2 NA = Not Applicable; no acute dietary endpoint was identified for these population subgroups.

Table 6.  Summary of Dietary Exposure and Risk for Fenarimol with an EDWC of 66 ppb.

Population Subgroup1	DEEM Acute Dietary Analysis,

95th Percentile	DEEM Chronic Dietary Analysis

	Exposure (mg/kg/day)	% aPAD	Exposure (mg/kg/day)	% cPAD

General U.S. Population

NA 2

	0.001402	23

All Infants (< 1 year old)

0.004570	76

Children 1-2 years old

0.002080	35

Children 3-5 years old

0.001942	32

Children 6-12 years old

0.001337	22

Youth 13-19 years old

0.001010	17

Adults 20-49 years old

0.001315	22

Adults 50+ years old

0.001374	23

Females 13-49 years old

0.001300	22

1 Values for the population with the highest risk for each type of risk assessment are bolded.

2 NA = Not Applicable; no acute dietary endpoint was identified for these population subgroups.

VII.	Characterization of Inputs/Outputs

The chronic dietary exposure assessment for fenarimol is highly refined using anticipated residues based on FDA monitoring data for apples, bananas, cherries, grapes and pears.  Field trial residue data were used for pecans.  %CT information and processing factors, where available, were also used in the assessment. There were no PDP monitoring data available for fenarimol.  Bananas were included in the assessment to account for imported bananas.

VII.	Conclusions

As noted above, dietary risk estimates for fenarimol exceed ARIA’s level of concern at an EDWC of 226 ppb.  At an EDWC of 66 ppb, dietary risk estimates for fenarimol are below ARIA’s level of concern for all population subgroups, including those comprised of infants and children.  The highest exposed population subgroup, all infants (<1 year old), results in a cPAD of 76%.

VIII.	List of Attachments

Attachment 1:  Chronic Food plus Water Residue Input File at the EDWC of 226 ppb

Attachment 2:  Chronic Results File at the EDWC of 226 ppb

Attachment 3:  Chronic Food plus Water Residue Input File at the EDWC of 66 ppb

Attachment 4:  Chronic Results File at the EDWC of 66 ppb

cc:  T. Gibson/M. Waller RM 21

Attachment 1:  Chronic Food plus Water Residue Input File at the EDWC of 226 ppb

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for FENARIMOL                          1994-98 data

Residue file: C:\Documents and Settings\bhanson\My Documents\Breann's Work\Aria\Fenarimol\Finals\FINALS\206600c.R98

                                                               Adjust. #2 used

Analysis Date 07-21-2009             Residue file dated: 07-21-2009/13:27:11/8

Reference dose (RfD) = 0.006 mg/kg bw/day

Comment:6E7074

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

Food Crop                                       Residue       Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)

                                                             #1         #2

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

11000070 11   Apple, fruit with peel             0.001500   1.000      0.200

11000080 11   Apple, peeled fruit                0.001500   1.000      0.200

11000081 11   Apple, peeled fruit-babyfood       0.001500   1.000      0.200

11000090 11   Apple, dried                       0.001500   8.000      0.200

11000091 11   Apple, dried-babyfood              0.001500   8.000      0.200

11000100 11   Apple, juice                       0.001500   0.050      0.200

11000101 11   Apple, juice-babyfood              0.001500   0.050      0.200

11000110 11   Apple, sauce                       0.001500   1.000      0.200

11000111 11   Apple, sauce-babyfood              0.001500   1.000      0.200

95000230 O    Banana                             0.004500   1.000      1.000

95000231 O    Banana-babyfood                    0.004500   1.000      1.000

95000240 O    Banana, dried                      0.004500   3.900      1.000

95000241 O    Banana, dried-babyfood             0.004500   3.900      1.000

21000440 M    Beef, meat                         0.000090   1.000      0.200

21000441 M    Beef, meat-babyfood                0.000090   1.000      0.200

21000450 M    Beef, meat, dried                  0.000090   1.920      0.200

21000460 M    Beef, meat byproducts              0.000300   1.000      0.200

21000461 M    Beef, meat byproducts-babyfood     0.000300   1.000      0.200

21000470 M    Beef, fat                          0.000100   1.000      0.200

21000471 M    Beef,fat-babyfood                  0.000100   1.000      0.200

21000480 M    Beef, kidney                       0.000100   1.000      0.200

12000900 12   Cherry                             0.003400   1.000      0.150

12000901 12   Cherry-babyfood                    0.003400   1.000      0.150

12000910 12   Cherry, juice                      0.003400   1.500      0.150

12000911 12   Cherry, juice-babyfood             0.003400   1.500      0.150

14001550 14   Filbert                            0.010000   1.000      1.000

14001560 14   Filbert, oil                       0.010000   1.000      1.000

23001690 M    Goat, meat                         0.000090   1.000      0.200

23001700 M    Goat, meat byproducts              0.000300   1.000      0.200

23001710 M    Goat, fat                          0.000100   1.000      0.200

23001720 M    Goat, kidney                       0.000100   1.000      0.200

95001750 O    Grape                              0.006000   1.000      0.250

95001760 O    Grape, juice                       0.006000   1.200      0.250

95001761 O    Grape, juice-babyfood              0.006000   1.200      0.250

95001770 O    Grape, leaves                      0.006000   1.000      0.250

95001780 O    Grape, raisin                      0.006000   1.600      0.250

95001790 O    Grape, wine and sherry             0.006000   1.000      0.250

95001880 O    Hop                                1.200000   1.000      1.000

24001890 M    Horse, meat                        0.000090   1.000      0.200

11002660 11   Pear                               0.001500   1.000      0.100

11002661 11   Pear-babyfood                      0.001500   1.000      0.100

11002670 11   Pear, dried                        0.001500   6.250      0.100

11002680 11   Pear, juice                        0.001500   0.050      0.100

11002681 11   Pear, juice-babyfood               0.001500   0.050      0.100

14002690 14   Pecan                              0.003700   1.000      1.000

95002830 O    Plantain                           0.004500   1.000      1.000

95002840 O    Plantain, dried                    0.004500   3.900      1.000

26003390 M    Sheep, meat                        0.000090   1.000      0.200

26003391 M    Sheep, meat-babyfood               0.000090   1.000      0.200

26003400 M    Sheep, meat byproducts             0.000300   1.000      0.200

26003410 M    Sheep, fat                         0.000100   1.000      0.200

26003411 M    Sheep, fat-babyfood                0.000100   1.000      0.200

26003420 M    Sheep, kidney                      0.000100   1.000      0.200

86010000 O    Water, direct, all sources         0.226000   1.000      1.000

86020000 O    Water, indirect, all sources       0.226000   1.000      1.000

Attachment 2:  Chronic Results File at the EDWC of 226 ppb

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for FENARIMOL                        (1994-98 data)

Residue file name: C:\Documents and Settings\bhanson\My Documents\Breann's Work\Aria\Fenarimol\Finals\FINALS\206600c.R98

                                                     Adjustment factor #2 used.

Analysis Date 07-21-2009/13:29:34     Residue file dated: 07-21-2009/13:27:11/8

Reference dose (RfD, Chronic) = .006 mg/kg bw/day

COMMENT 1: 6E7074

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

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

U.S. Population (total)                     0.004775                79.6%

U.S. Population (spring season)             0.004735                78.9%

U.S. Population (summer season)             0.005129                85.5%

U.S. Population (autumn season)             0.004614                76.9%

U.S. Population (winter season)             0.004615                76.9%

Northeast region                            0.004355                72.6%

Midwest region                              0.004828                80.5%

Southern region                             0.004538                75.6%

Western region                              0.005471                91.2%

Hispanics                                   0.005417                90.3%

Non-hispanic whites                         0.004659                77.7%

Non-hispanic blacks                         0.004530                75.5%

Non-hisp/non-white/non-black                0.005848                97.5%

All infants (< 1 year)                      0.015626               260.4%

Nursing infants                             0.005798                96.6%

Non-nursing infants                         0.019356               322.6%

Children 1-6  yrs                           0.006665               111.1%

Children 7-12 yrs                           0.004330                72.2%

Females 13-19 (not preg or nursing)         0.003354                55.9%

Females 20+ (not preg or nursing)           0.004762                79.4%

Females 13-50 yrs                           0.004616                76.9%

Females 13+ (preg/not nursing)              0.004634                77.2%

Females 13+ (nursing)                       0.006603               110.1%

Males 13-19 yrs                             0.003511                58.5%

Males 20+ yrs                               0.004289                71.5%

Seniors 55+                                 0.004683                78.1%

Children 1-2 yrs                            0.007088               118.1%

Children 3-5 yrs                            0.006630               110.5%

Children 6-12 yrs                           0.004571                76.2%

Youth 13-19 yrs                             0.003448                57.5%

Adults 20-49 yrs                            0.004464                74.4%

Adults 50+ yrs                              0.004687                78.1%

Females 13-49 yrs                           0.004436                73.9%

Attachment 3:  Chronic Food plus Water Residue Input File at the EDWC of 66 ppb

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for FENARIMOL                          1994-98 data

Residue file: C:\Documents and Settings\bhanson\My Documents\Breann's Work\Aria\Fenarimol\Finals\FINALS\206600c(water66).R98

                                                               Adjust. #2 used

Analysis Date 07-21-2009             Residue file dated: 07-21-2009/13:28:50/8

Reference dose (RfD) = 0.006 mg/kg bw/day

Comment:6E7074

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

Food Crop                                       Residue       Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)

                                                             #1         #2

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

11000070 11   Apple, fruit with peel             0.001500   1.000      0.200

11000080 11   Apple, peeled fruit                0.001500   1.000      0.200

11000081 11   Apple, peeled fruit-babyfood       0.001500   1.000      0.200

11000090 11   Apple, dried                       0.001500   8.000      0.200

11000091 11   Apple, dried-babyfood              0.001500   8.000      0.200

11000100 11   Apple, juice                       0.001500   0.050      0.200

11000101 11   Apple, juice-babyfood              0.001500   0.050      0.200

11000110 11   Apple, sauce                       0.001500   1.000      0.200

11000111 11   Apple, sauce-babyfood              0.001500   1.000      0.200

95000230 O    Banana                             0.004500   1.000      1.000

95000231 O    Banana-babyfood                    0.004500   1.000      1.000

95000240 O    Banana, dried                      0.004500   3.900      1.000

95000241 O    Banana, dried-babyfood             0.004500   3.900      1.000

21000440 M    Beef, meat                         0.000090   1.000      0.200

21000441 M    Beef, meat-babyfood                0.000090   1.000      0.200

21000450 M    Beef, meat, dried                  0.000090   1.920      0.200

21000460 M    Beef, meat byproducts              0.000300   1.000      0.200

21000461 M    Beef, meat byproducts-babyfood     0.000300   1.000      0.200

21000470 M    Beef, fat                          0.000100   1.000      0.200

21000471 M    Beef,fat-babyfood                  0.000100   1.000      0.200

21000480 M    Beef, kidney                       0.000100   1.000      0.200

12000900 12   Cherry                             0.003400   1.000      0.150

12000901 12   Cherry-babyfood                    0.003400   1.000      0.150

12000910 12   Cherry, juice                      0.003400   1.500      0.150

12000911 12   Cherry, juice-babyfood             0.003400   1.500      0.150

14001550 14   Filbert                            0.010000   1.000      1.000

14001560 14   Filbert, oil                       0.010000   1.000      1.000

23001690 M    Goat, meat                         0.000090   1.000      0.200

23001700 M    Goat, meat byproducts              0.000300   1.000      0.200

23001710 M    Goat, fat                          0.000100   1.000      0.200

23001720 M    Goat, kidney                       0.000100   1.000      0.200

95001750 O    Grape                              0.006000   1.000      0.250

95001760 O    Grape, juice                       0.006000   1.200      0.250

95001761 O    Grape, juice-babyfood              0.006000   1.200      0.250

95001770 O    Grape, leaves                      0.006000   1.000      0.250

95001780 O    Grape, raisin                      0.006000   1.600      0.250

95001790 O    Grape, wine and sherry             0.006000   1.000      0.250

95001880 O    Hop                                1.200000   1.000      1.000

24001890 M    Horse, meat                        0.000090   1.000      0.200

11002660 11   Pear                               0.001500   1.000      0.100

11002661 11   Pear-babyfood                      0.001500   1.000      0.100

11002670 11   Pear, dried                        0.001500   6.250      0.100

11002680 11   Pear, juice                        0.001500   0.050      0.100

11002681 11   Pear, juice-babyfood               0.001500   0.050      0.100

14002690 14   Pecan                              0.003700   1.000      1.000

95002830 O    Plantain                           0.004500   1.000      1.000

95002840 O    Plantain, dried                    0.004500   3.900      1.000

26003390 M    Sheep, meat                        0.000090   1.000      0.200

26003391 M    Sheep, meat-babyfood               0.000090   1.000      0.200

26003400 M    Sheep, meat byproducts             0.000300   1.000      0.200

26003410 M    Sheep, fat                         0.000100   1.000      0.200

26003411 M    Sheep, fat-babyfood                0.000100   1.000      0.200

26003420 M    Sheep, kidney                      0.000100   1.000      0.200

86010000 O    Water, direct, all sources         0.066000   1.000      1.000

86020000 O    Water, indirect, all sources       0.066000   1.000      1.000

Attachment 4:  Chronic Results File at the EDWC of 66 ppb.

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for FENARIMOL                        (1994-98 data)

Residue file name: C:\Documents and Settings\bhanson\My Documents\Breann's Work\Aria\Fenarimol\Finals\FINALS\206600c(water66).R98

                                                     Adjustment factor #2 used.

Analysis Date 07-21-2009/13:31:06     Residue file dated: 07-21-2009/13:28:50/8

Reference dose (RfD, Chronic) = .006 mg/kg bw/day

COMMENT 1: 6E7074

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

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

U.S. Population (total)                     0.001402                23.4%

U.S. Population (spring season)             0.001392                23.2%

U.S. Population (summer season)             0.001506                25.1%

U.S. Population (autumn season)             0.001354                22.6%

U.S. Population (winter season)             0.001355                22.6%

Northeast region                            0.001279                21.3%

Midwest region                              0.001419                23.6%

Southern region                             0.001332                22.2%

Western region                              0.001607                26.8%

Hispanics                                   0.001589                26.5%

Non-hispanic whites                         0.001369                22.8%

Non-hispanic blacks                         0.001328                22.1%

Non-hisp/non-white/non-black                0.001714                28.6%

All infants (< 1 year)                      0.004570                76.2%

Nursing infants                             0.001697                28.3%

Non-nursing infants                         0.005660                94.3%

Children 1-6  yrs                           0.001953                32.6%

Children 7-12 yrs                           0.001267                21.1%

Females 13-19 (not preg or nursing)         0.000981                16.3%

Females 20+ (not preg or nursing)           0.001395                23.3%

Females 13-50 yrs                           0.001353                ㈲㘮ഥ敆慭敬⁳㌱瀨敲⽧潮⁴畮獲湩⥧†††††† †⸰〰㌱㔵††††††††㈲㘮ഥ敆慭敬⁳㌱渨牵 楳杮
†††††††††††⸰〰㤱ㄳ†††††† ††㈳㈮ഥ䴍污獥ㄠⴳ㤱礠獲††††††††††† †††〠〮㄰㌰‰†††††††ㄠ⸷┲

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 hSR

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 hSR

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摧挻bᬀMales 20+ yrs                               0.001267                21.1%

Seniors 55+                                 0.001373                22.9%

Children 1-2 yrs                            0.002080                34.7%

Children 3-5 yrs                            0.001942                32.4%

Children 6-12 yrs                           0.001337                22.3%

Youth 13-19 yrs                             0.001010                16.8%

Adults 20-49 yrs                            0.001315                21.9%

Adults 50+ yrs                              0.001374                22.9%

Females 13-49 yrs                           0.001300                21.7%

l

Fenarimol	Dietary Exposure Assessment	DP#: 331895

PC Code: 206600

 PAGE

Page  PAGE   15  of 15


[Federal Register Volume 84, Number 70 (Thursday, April 11, 2019)]
[Notices]
[Pages 14685-14686]
[FR Doc No: 2019-07200]

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

SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

Extension:
    Rule 19d-1, SEC File No. 270-242, OMB Control No. 3235-0206

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.) (``PRA''), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the existing
collection of information provided for in Rule 19d-1 (17 CFR 240.19d-1)
under the Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.)
(``Exchange Act''). The Commission plans to submit this existing
collection of information to the Office of Management and Budget)
(``OMB'') for extension and approval.
    Rule 19d-1 prescribes the form and content of notices to be filed
with the Commission by self-regulatory organizations (``SROs'') for
which the Commission is the appropriate regulatory agency concerning
the following final SRO actions: (1) Disciplinary actions with respect
to any person; (2) denial, bar, prohibition, or limitation of
membership, participation or association with a member or of access to
services offered by an SRO or member thereof; (3) summarily suspending
a member, participant, or person associated with a member, or summarily
limiting or prohibiting any persons with respect to access to or
services offered by the SRO or a member thereof; and (4) delisting a
security.
    The Rule enables the Commission to obtain reports from the SROs
containing information regarding SRO determinations to delist a
security, discipline members or associated persons of members, deny
membership or participation or association with a member, and similar
adjudicated findings. The Rule requires that such actions be promptly
reported to the Commission. The Rule also requires that the reports and
notices supply sufficient information regarding the background, factual
basis and issues involved in the proceeding to enable the Commission:
(1) To determine whether the matter should be called up for review on
the Commission's own motion; and (2) to ascertain generally whether the
SRO has adequately carried out its responsibilities under the Exchange
Act.
    It is estimated that approximately eighteen respondents will
utilize this application procedure annually, and will file
approximately 1,350 submissions, based upon recent data. The Commission
estimates that the average number of hours necessary to comply with the
requirements of Rule 19d-1 for each submission is 1 hour. The total
annual burden for all respondents is thus 1,350 hours. The Commission
estimates that the internal compliance cost per respondent is
approximately $298 per response. The annual internal cost of compliance
for all respondents is thus approximately $402,300 (18 respondents x 75
responses x $298 per response).
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimates of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use

of automated collection techniques or other forms of information
technology. Consideration will be given to comments and suggestions
submitted in writing within 60 days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: Charles Riddle, Acting
Director/Chief Information Officer, Securities and Exchange Commission,
c/o Candace Kenner, 100 F Street NE, Washington, DC 20549 or send an
email to: [email protected].

    Dated: April 8, 2019.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-07200 Filed 4-10-19; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: December 15, 2006 (Volume 71, Number 241)]
[Notices]
[Page 75528]
[DOCID:fr15de06-58]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM06-16-000]

Mandatory Reliability Standards for the Bulk-Power System; Notice
of Filing

December 8, 2006.
    On December 1, 2006, the North American Electric Reliability
Council, on behalf of its affiliate, the North American Electric
Reliability Corporation (collectively NERC), made an informational
filing with the Commission entitled ``NERC's Reliability Standards
Development Plan: 2007-2009'' (Work Plan).\1\ NERC states that the Work
Plan has been submitted to inform the Commission of NERC's program to
improve the Reliability Standards that currently are the subject of the
Commission's Notice of Proposed Rulemaking (NOPR) issued in this docket
on October 20, 2006. NERC states that a portion of the Work Plan also
fulfills the commitment made in its April 2006 ERO certification
application to provide the Commission with a plan to address the
``fill-in-the-blank'' regional reliability standards. Finally, the
informational filing contains a status report on the violation risk
factors that NERC plans to assign to each requirement in NERC's
Reliability Standards to help delineate the relative risks associated
with the violation of each requirement of a Reliability Standard.
---------------------------------------------------------------------------

    \1\ The Commission certified NERC Corporation as the Electric
Reliability Organization (ERO) pursuant to Section 215 of the
Federal Power Act in an order issued July 20, 2006, in Docket No.
RR06-1-000.
---------------------------------------------------------------------------

    The Commission stated in its October 20, 2006 NOPR that it is
important that the ERO develop a detailed, comprehensive work plan to
address all of the modifications that are directed pursuant to a final
rule issued in this docket. The Commission believes that the Work Plan
could be useful for determining such prioritization and would therefore
be informative for the final rule. The Commission also believes that
industry comment on the Work Plan would assist in developing an
appropriate prioritization plan.
    The Commission therefore seeks public comment on the Work Plan,
with comments due by the January 3, 2007 to coincide with the date for
filing comments on the October 20, 2006 NOPR.
    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>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-21387 Filed 12-14-06; 8:45 am]

BILLING CODE 6717-01-P


P-20-0027-0028 Sanitized Support Documents Index:
 P-20-0027-0028 Sanitized Determination Document (linked)
 P-20-0027 Sanitized CHEM Report (attached)
 P-20-0028 Sanitized CHEM Report (attached)
 P-20-0027 Sanitized ECO Report (attached)
 P-20-0028 Sanitized ECO Report (attached)
 P-20-0027-0028 Sanitized ENG Report (attached)
 P-20-0027 Sanitized EXP Report (attached)
 P-20-0028 Sanitized EXP Report (attached)
 P-20-0027 Sanitized Fate Report (attached)
 P-20-0028 Sanitized Fate Report (attached)
 P-20-0027-0028 Sanitized HLTH Report_POST-FOCUS FINAL (attached)


[Federal Register: March 19, 2007 (Volume 72, Number 52)]
[Notices]
[Page 12792-12793]
[DOCID:fr19mr07-56]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2206-030]

Carolina Power & Light Company; Notice of Application Ready for
Environmental Analysis and Soliciting Comments, Recommendations, Terms
and Conditions, and Prescriptions

March 13, 2007.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New Major License.
    b. Project No.: 2206-030.
    c. Date Filed: April 26, 2006.
    d. Applicant: Carolina Power & Light Company (d/b/a Progress Energy
Carolinas, Inc.).
    e. Name of Project: Yadkin-Pee Dee Hydroelectric Project.
    f. Location: On the Yadkin and Pee Dee Rivers, in Montgomery,
Stanly, Anson, and Richmond Counties, North Carolina. The project does
not occupy any Federal lands.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)--825(r).
    h. Applicant Contact: E. Michael Williams, Senior Vice President
for Power Operations, Progress Energy, 410 S. Wilmington Street PEB 13,
Raleigh, North Carolina 27602; Telephone<PHONE_NUMBER>.

    i. FERC Contact: Stephen Bowler,<PHONE_NUMBER>; or
<EMAIL_ADDRESS>
    j. The deadline for filing comments, recommendations, terms and
conditions, and prescriptions is 60 days from the issuance of this
notice; reply comments are due 105 days from the issuance date of this
notice.
    All documents (original and eight copies) should be filed with:
Philis J. Posey, Acting Secretary, Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person 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.
    Comments, recommendations, terms and conditions, and prescriptions
may be filed electronically via the Internet in lieu of paper. The
Commission strongly encourages electronic filings. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
(http://www.ferc.gov) under the ``e-Filing'' link.

    k. This application has been accepted and is ready for
environmental analysis at this time.
    l. The existing Yadkin-Pee Dee Project consists of the Tillery
development on the Yadkin and Pee Dee Rivers and the Blewett Falls
development on the Pee Dee River. The Yadkin Pee Dee project has an
installed capacity of 108.6 megawatts (MW). The project produces an
average annual generation of 326,000 megawatt-hours (MWh).
    The Tillery development (at River Mile[RM] 218) includes the
following existing facilities: (1) A 2,753-foot-long, 62-foot-maximum
height dam with (i) A 1,200-foot-long earth dike, (ii) a 184-foot-long
concrete west abutment, (iii) a 731-foot-long gated concrete gravity
spillway with eighteen 34-foot-wide by 24-foot-high Tainter gates, (iv)
a 14-foot-long by 10-foot-high trash sluice gate, (v) a 310-foot-long
powerhouse integral with the dam containing three vertical Francis
turbine-generators, one modified Kaplin-type turbine-generator, and one
vertical Francis auxiliary turbine-generator with a total generating
capacity of 84 MW, and (vi) a 310-foot-long concrete east abutment; (2)
a 5,697-acre reservoir at normal pool elevation of 277.3 feet North
American Vertical Datum of 1988 (NAVD 88), with 84,150 acre-feet of
usable storage capacity; and (3) appurtenant facilities. The Tillery
development would continue to be operated as a peaking facility with a
typical drawdown of not more than 4 feet under normal conditions.
    The Blewett Falls development (at RM 188.2) includes the following
existing facilities: (1) A 3,168-foot-long dam with a 870-foot-long
easterly earthen embankment, (i) 1,468-foot-long, 47 foot average
height concrete ogee gravity spillway topped with four feet wooden
flashboards, (ii) a 850-foot-long westerly earthen embankment, (iii) a
300-foot-long, approximately 100-foot-high concrete powerhouse
containing six generating units (each unit driven by two horizontal
shaft turbines with each turbine consisting of two runners) with a
total generating capacity of 24.6 MW; (2) a 2,866-acre reservoir at
normal pool elevation of 177.2 feet NAVD 88, with 30,893 acre-feet of
usable storage capacity; (3) a 900-foot-long tailrace channel which
reconnects to the Pee Dee River; and (4) appurtenant facilities. There
is a 1,750-foot-long bypassed reach between the dam and where the
tailrace channel enters the Pee Dee River.
    Progress Energy proposes to continue operating the projects in the
same operational mode. Several proposed modifications to the project
include: (1) Making minor changes in reservoir elevations during the
winter, under maintenance conditions, and during the largemouth bass
spawning period; (2) increasing the minimum flow releases from the
Tillery and Blewett Falls developments and using flow-shaping releases
during fish spawning periods; (3) implementing fish passage measures,
including trap and truck procedures and constructing eel passage
facilities at the Blewett Falls development; (4) adopting a shoreline
management policy for the Blewett Falls development; (5) improving
recreational access, facilities, and trails, and closing the informal
boating area below the Tillery development powerhouse and relocating
it; and (6) constructing a new public boating access site on the east
side of Blewett Falls reservoir.
    m. 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 at<EMAIL_ADDRESS>or toll-free at 1-
866-208-3676, or for TTY,<PHONE_NUMBER>. A copy is also available for
inspection and reproduction at the address in item h above.
    All filings must: (1) Bear in all capital letters the title
``COMMENTS,'' ``REPLY COMMENTS,'' ``RECOMMENDATIONS,'' ``TERMS AND
CONDITIONS,'' or ``PRESCRIPTIONS;'' (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 submitting the filing; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, recommendations, terms and conditions or prescriptions must
set forth their evidentiary basis and otherwise comply with the
requirements of 18 CFR 4.34(b). Agencies may obtain copies of the
application directly from the applicant. Each filing must be
accompanied by proof of service on all persons listed on the service
list prepared by the Commission in this proceeding, in accordance with
18 CFR 4.34(b), and 385.2010.
    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.
    n. A license applicant must file no later than 60 days following
the date of issuance of this notice: (1) A copy of the water quality
certification; (2) a copy of the request for certification, including
proof of the date on which the certifying agency received the request;
or (3) evidence of waiver of water quality certification.

Philis J. Posey,
Acting Secretary.
[FR Doc. E7-4992 Filed 3-16-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 79 (Monday, April 25, 2022)]
[Notices]
[Pages 24321-24322]
[FR Doc No: 2022-08739]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0801]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Export Notification
and Recordkeeping Requirements

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by May 25, 2022.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0482. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Export Notification and Recordkeeping Requirements

OMB Control Number 0910-0482--Extension

    Sections 801 and 802 of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 381 and 382) charge the Secretary of Health and
Human Services, through FDA, with the responsibility of helping to
ensure that exports of unapproved new drugs, biologics, devices, animal
drugs, food, cosmetics, and tobacco products that are not to be sold in
the United States meet the requirements of the country to which the
product is to be exported. The respondents to this information
collection are exporters who have notified FDA of their intent to
export unapproved products that may not be sold or offered for sale in
domestic commerce in the United States as allowed under section 801(e)
of the FD&C Act. In general, the notification

identifies the product being exported (e.g., name, description, and in
some cases, country of destination) and specifies where the
notifications were sent. These notifications are sent only for an
initial export. Subsequent exports of the same product to the same
destination or to certain countries identified in section 802(b) of the
FD&C Act would not result in a notification to FDA.
    Respondents to the information collection are exporters of products
that may not be sold in the United States and are regulated by FDA's
Center for Drug Evaluation and Research (CDER); Center for Biologics
Evaluation and Research (CBER); Center for Devices and Radiological
Health (CDRH); Center for Veterinary Medicine (CVM); Center for Food
Safety and Applied Nutrition (CFSAN); and Center for Tobacco Products.
Respondents to this collection of information maintain records
demonstrating their compliance with the requirements in 21 CFR 1.101.
    In the Federal Register of January 25, 2022 (87 FR 3811), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    We estimate the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
1.101(d) (CBER).................               4              35             140              15           2,100
1.101(d) (CDER).................               3              57             171              15           2,565
1.101(d) (CDRH).................              22               4              88              15           1,320
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           5,985
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
         21 CFR section              Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
1.101(b), (c), and (e) (CBER,                181            4.12             746              22          16,412
 CDER, CDRH, CFSAN, and CVM)....
1.101(b) Office of International               1              65              65              22           1,430
 Programs only..................
1.101(b) (currently regulated                322               3             966              22          21,252
 Tobacco Products)..............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          39,094
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on a review of Agency data, we decreased our estimate by
24,251 burden hours. This decrease reflects an overall downward trend
in the number of export certification requests across programs and
commodities. The estimate for tobacco products remains steady.

    Dated: April 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08739 Filed 4-22-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 134 (Friday, July 12, 2019)]
[Rules and Regulations]
[Pages 33169-33172]
[FR Doc No: 2019-14876]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2018-0007]
RIN 1625-AA87

Security Zones; Port of Palm Beach, Port Everglades, Port of
Miami, and Port of Key West, Florida

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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

SUMMARY: The Coast Guard is modifying the existing security zone
regulations for the Port of Palm Beach, Port Everglades, Port of Miami,
and Port of Key West Florida. The amendments will create a new section
for Sector Key West security zones; clarify when the Port Everglades
fixed security zones will be in effect; modify and lengthen a portion
of one Port Everglades fixed security zone; and update language and
definitions throughout the regulation. The security zones are intended
to protect the public and ports from potential subversive acts.

DATES: This rule is effective August 12, 2019.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2018-0007 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Samuel Rodriguez-Gonzalez, Sector Miami
Waterways Management Division, U.S. Coast Guard; telephone (305) 535-
4307, email<EMAIL_ADDRESS>or BMC Greg Bergstrom,
Sector Key West 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 Information and Regulatory History

    The Coast Guard published a notice of proposed rulemaking \1\
(NPRM) on September 16, 2016. The comment period closed on November 15,
2016. The Coast Guard received two comments. Based on the comments
received we made minute changes to specific coordinates of the proposed
security zone listed in Sec.  165.760(b)(3) to provide a larger
security ``standoff'' distance. We issued a supplemental notice of
proposed rulemaking \2\ (SNPRM) on February 7, 2019 to provide the
public with an opportunity to comment on these supplemental changes.
The comment period on the SNPRM closed on March 11, 2019. We received
two comments on the SNPRM, which are discussed below.
---------------------------------------------------------------------------

    \1\ The NPRM was issued under docket number USCG-2016-0327 (see
81 FR 63728).
    \2\ The SNPRM was issued under docket number, USCG-2018-0007
(see 84 FR 2479).
---------------------------------------------------------------------------

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The purpose of this rule is to
establish separate regulatory authority for Sector Key West, clarify
when the Port Everglades fixed security zones will be in effect, modify
and lengthen a portion of one of the Port Everglades fixed security
zones, update language throughout the regulation for administrative
reasons, and to protect the public and Ports from potential subversive
acts.

IV. Discussion of the SNPRM and the Rule

    As noted above, we received two comments on the SNPRM. The first
commenter was in support of the security zone, but noted incorrect
terms for landmarks used in the preamble. This commenter pointed out
that the SNPRM's preamble incorrectly referred to Berth 7 as the
southern point of the fixed security zone encompassing the Port
Everglades Turning Basin and cruise and petroleum berths. However, the
commenter noted that the SNPRM's regulatory text in Sec.
165.760(b)(3), correctly referred to the northern tip of Berth 22. The
regulatory text that will appear in the final rule has the correct
wording and uses latitude and longitude designations to avoid any
confusion.
    The same commenter noted that while the moving security zone would
only apply to passenger vessels and other vessels carrying cargoes of a
particular hazard, or liquefied hazardous gas, it might be necessary to
extend that to other vessels at higher Maritime Security (MARSEC)
levels using other existing Captain of the Port (COTP) authorities. The
security zone discussed in this rule is a fixed security zone, and does
not contain a moving security zone. At higher MARSEC levels, Port
Everglades will increase their security measures accordingly to
mitigate security vulnerabilities and ensure the safety of all vessels.
    The second commenter asked how the Coast Guard would deal with the
increase in patrols, and wanted to know if the Coast Guard is equipped
to handle the extra workload. The Coast Guard works closely with
Broward County Sheriff's Office to ensure the security zone is enforced
in Port Everglades. Increased vessel traffic has been managed with
success, and has not been a concern. The updated fixed security zone
extends further south than the security zone it is replacing, but that
is not expected to result in more patrols. The longer security zone
will increase the geographic area that law enforcement vessels will
patrol; however, the patrols are not expected to be conducted more
often as a result of the updated security zone.
    We note we erroneously mentioned in the preamble of the SNPRM that
we were going to revise the regulatory text by using the names of state
parks when referencing certain coordinates. It was determined that the
names of the state parks did not add any clarity to the regulatory
text; therefore, we did not propose this change after all.
    With this final rule, we are finalizing the regulatory text
proposed in the SNPRM without any further revisions.

V. Regulatory Analyses

    We developed this 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 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the following
reasons: (1) Persons and vessels would still be able to operate in
waters surrounding security zones; (2) the permanent fixed security
zone encompassing Port Everglades from Mid-Port to North-Port is within
the natural boundaries of the Port and is limited in size; (3)
notification of the security zones will be made to the local maritime
community via posted signs and Broadcast Notice to Mariners on VHF-FM
marine channels 16 when applicable; and (4) persons and vessels may
operate within the security zone if authorized by Captain of the Port
Miami, Captain of the Port Key West, or a 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 received no comments from the Small Business
Administration on this rulemaking. The Coast Guard certifies under 5
U.S.C. 605(b) that this rule will not have a significant economic
impact on a substantial number of small entities.
    This rule may affect the following entities, some of which may be
small entities: People and the owners or operators of vessels intending
to transit or remain within the security zone(s) when they are in
effect. For reasons discussed in section V.A. Regulatory Planning and
Review above, this rule will not have a significant economic impact on
a substantial number of small entities.
    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 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.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will 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 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 rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does 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 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 rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have
determined 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 rule involves amending security zones. It is
categorically excluded from further review under paragraph L60(a) in
Table 3-1 of U.S. Coast Guard Environmental Planning Implementing
Procedures 5090.1. A Memorandum for the Record (MFR) supporting this
determination is available in the docket where indicated under
ADDRESSES.

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.

List of Subjects in 33 CFR Part 165

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

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.760 to read as follows:

Sec.  165.760   Security Zones; Port of Palm Beach, Port Everglades,
and Port of Miami, Florida.

    (a) Definitions. (1) As used in this section, passenger vessel is a
vessel greater than 100 feet in length and over 100 gross tons that is
authorized to carry more than 12 passengers for hire making voyages
lasting more than 24 hours, except for a ferry.
    (2) As used in this section, a vessel carrying cargoes of
particular hazard is defined in 33 CFR part 126 and a vessel carrying
liquefied hazardous gas (LHG) is defined in 33 CFR part 127.
    (b) Locations. The following areas are security zones (all
coordinates are North American Datum 1983):
    (1) Fixed and moving security zones around vessels in the Port of
Palm Beach, Port Everglades, and Port of Miami, Florida. Moving
security zones are established 100 yards around all passenger vessels,
vessels carrying cargoes of particular hazard, or vessels carrying
liquefied hazardous gas (LHG) during transits entering or departing the
Port of Palm Beach, Port Everglades, or Port of Miami. These moving
security zones are activated when the subject vessel passes: Lake Worth
Lighted Buoy LW, at approximate position 26[deg]46'22'' N,
80[deg]00'37'' W, when entering the Port of Palm Beach; passes Port
Everglades Lighted Buoy PE, at approximate position 26[deg]05'30'' N,
080[deg]04'46'' W, when entering Port Everglades; and passes Miami
Lighted Buoy M, at approximate position 25[deg]46'05'' N,
080[deg]05'01'' W, when entering Port of Miami. These moving security
zones remain active whenever a passenger vessel, vessels carrying
cargoes of particular hazard, or vessels carrying LHG is underway
westward of the above mentioned buoys. Fixed security zones are
established 100 yards around all passenger vessels, vessels carrying
cargoes of particular hazard, or vessels carrying LHG, while the vessel
is moored in the Port of Palm Beach, Port Everglades, or Port of Miami,
Florida. Persons and vessels may pass within 100 yards of a moored
passenger vessel, vessel carrying cargoes of particular hazard, or
vessel carrying LHG that is moored within or alongside a Federal
channel as long as the passage occurs outside of the on scene law
enforcement vessel. Persons and vessels shall pass north of the on
scene law enforcement vessel when north of the Port of Miami, south of
the on scene law enforcement vessel when south of the Port of Miami and
east of the on scene law enforcement vessel in Port Everglades.
    (2) Fixed security zone in Port of Miami, Florida. A fixed security
zone encompasses all waters between Watson Park and Star Island from
the MacArthur Causeway south to Port of Miami. The western boundary is
formed by an imaginary line from points 25[deg]46'45'' N,
080[deg]10'52'' W, northwest to 25[deg]46'46'' N, 080[deg]10'54'' W,
northeast to 25[deg]46'53'' N, 080[deg]10'50'' W, and extending
northeast ending at Watson Island at 25[deg]47'00'' N, 080[deg]10'40''
W. The eastern boundary is formed by an imaginary line approximately
100 yards west of the Fisher Island Ferry terminal, in approximate
position 25[deg]46'20'' N, 080[deg]09'07'' W, extending southwest
across the Main Channel to Port of Miami, at 25[deg]46'16'' N,
080[deg]09'11'' W. The fixed security zone is in effect when two or
more passenger vessels, vessels carrying cargoes of particular hazard,
or vessels carrying LHG, enter or moor within this zone.
    (i) When the security zone is in effect, persons and vessels shall
not enter or transit the security zone along the Miami Main Channel
unless authorized by Captain of the Port of Miami or a designated
representative.
    (ii) Persons and vessels may transit the Miami Main Channel when
only one passenger vessel, one vessel carrying cargoes of particular
hazard or one vessel carrying LHG is berthed.
    (iii) Law enforcement vessels can be contacted on VHF Marine Band
Radio, Channel 16 (156.8 MHz).
    (3) Fixed security zones in Port Everglades. A fixed security zone
encompasses Mid-Port to North-Port in Port Everglades and includes all
waters west of an imaginary line starting at the southernmost point
26[deg]05'24'' N, 080[deg]06'57'' W, on the northern tip of Berth 22,
to the northernmost point 26[deg]06'01'' N, 080[deg]07'09'' W, near the
west side of the 17th Street Bridge and then move west to the
northwestern most point at 26[deg]06'01'' N, 080[deg]07'10'' W. An
additional fixed security zone encompasses the waters west of the
Intracoastal Waterway to the pier face of Port Everglades from Mid-Port
south to the northern tip of the Dania Cut-Off Canal and includes the
waters westward of the line connecting the following points to the pier
face of Port Everglades: Starting at 26[deg]05'25'' N, 080[deg]06'58''
W, on the northern tip of Berth 22 at Mid-Port, to a point directly
east along the Intracoastal Waterway, 26[deg]05'25'' N, 080[deg]06'54''
W, then southeast along the Intracoastal Waterway to 26[deg]05'10'' N,
080[deg]06'49'' W, then southwest along the Intracoastal Waterway to
26[deg]04'43'' N, 080[deg]06'53'' W, then south along the Intracoastal
Waterway to 26[deg]03'54'' N, 080[deg]06'52'' W, and then west to the
Port Everglades pier face just north of the Dania Cut-Off Canal at
26[deg]03'54'' N, 080[deg]06'55'' W.
    (i) Persons and vessels may transit the Intracoastal Waterway;
however, persons and vessels are not authorized to enter the fixed
security zone westward of the Intracoastal Waterway without
authorization from Captain of the Port Miami or a designated
representative. On occasion, a passenger vessel, vessel carrying
cargoes of particular hazard, or vessel carrying LHG may moor and
encroach into the Intracoastal Waterway. When this occurs, persons and
vessels shall transit the Intracoastal Waterway east of the on scene
law enforcement vessel.
    (ii) Periodically, vessels may be required to temporarily hold
their positions while large commercial traffic operates in this area.
Vessels near the security zone must follow the orders of the Captain of
the Port or the designated representative.
    (iii) Law enforcement vessels can be contacted on VHF Marine Band
Radio, Channel 16 (156.8 MHz).
    (c) Regulations. (1) Prior to commencing any movement, the person
directing the movement of a passenger vessel, a vessel carrying cargoes
of particular hazard, or a vessel carrying LHG is encouraged to make a
security broadcast on VHF Marine Band Radio Channel 16 (156.8 MHz) to
advise mariners of the moving security zone activation and intended
transit.
    (2) In accordance with the general regulations Sec.  165.33, entry
into these zones is prohibited, except as authorized by the Captain of
the Port of Miami or a designated representative. Vessels such as pilot
boats, tug boats, and contracted security vessels may assist the Coast
Guard Captain of the Port by monitoring these zones strictly to advise
mariners of the restrictions. The Captain of the Port will notify the
public of the security zone via signs or by Marine Safety Radio
Broadcasts on VHF Marine Band Radio Channel 16 (156.8 MHz) when
applicable.
    (3) Persons and vessels desiring to enter or transit the fixed or
moving security zones may contact the Captain of the Port Miami at
(305) 535-4472 or on VHF Marine Band Radio Channel 16 (156.8 MHz) to
seek permission to transit the area. If permission is granted, all
persons and vessels must comply with the instructions of the Captain of
the Port or the designated representative.
    (4) The Captain of the Port Miami may waive any of the requirements
of this section for any vessel upon finding that the vessel or class of
vessel, operational conditions, or other circumstances are such that
application of this section is unnecessary or impractical for the

purpose of port security, safety, or environmental safety.

0
3. Revise Sec.  165.761 to read as follows:

Sec.  165.761  Security Zones; Port of Key West, Florida.

    (a) Definitions. (1) As used in this section, passenger vessel is a
vessel greater than 100 feet in length and over 100 gross tons that is
authorized to carry more than 12 passengers for hire making voyages
lasting more than 24 hours, except for a ferry.
    (2) As used in this section, a vessel carrying cargoes of
particular hazard is defined in 33 CFR part 126 and a vessel carrying
liquefied hazardous gas (LHG) is defined in 33 CFR part 127.
    (b) Location. The following area is a security zone: Fixed and
moving security zones around vessels in the Port of Key West, Florida.
A moving security zones is established 100 yards around all passenger
vessels, vessels carrying cargoes of particular hazard, or vessels
carrying liquefied hazardous gas (LHG) during transits entering or
departing the Port of Key West, Florida. A moving security zones is
activated when the subject vessel passes Key West Entrance Lighted
Whistle Buoy KW, at approximate position 24[deg]27'26'' N,
081[deg]48'00'' W. This moving security zone remains active whenever a
passenger vessel, vessels carrying cargoes of particular hazard, or
vessels carrying LHG is underway westward of the above mentioned buoys.
Fixed security zones are established 100 yards around all passenger
vessels, vessels carrying cargoes of particular hazard, or vessels
carrying LHG, while the vessel is moored in the Port of Key West,
Florida.
    (c) Regulations. (1) Prior to commencing any movement, the person
directing the movement of a passenger vessel, a vessel carrying cargoes
of particular hazard, or a vessel carrying LHG, is encouraged to make a
security broadcast on VHF Marine Band Radio, Channel 16 (156.8 MHz) to
advise mariners of the moving security zone activation and intended
transit.
    (2) In accordance with the general regulations Sec.  165.33, entry
into these zones is prohibited except as authorized by the Captain of
the Port of Key West or a designated representative. Vessels such as
pilot boats, tug boats, and contracted security vessels may assist the
Coast Guard Captain of the Port by monitoring these zones strictly to
advise mariners of the restrictions. The Captain of the Port will
notify the public of the security zone via signs or by Marine Safety
Radio Broadcasts on VHF Marine Band Radio, Channel 16 (156.8 MHz) when
applicable.
    (3) Persons and vessels desiring to enter in, transit through,
anchor in, or remain within the fixed or moving security zones may
contact the Captain of the Port Key West at<PHONE_NUMBER> or on VHF
Marine Band Radio Channel 16 (156.8 MHz) to seek permission to transit
the area. If permission is granted, all persons and vessels must comply
with the instructions of the Captain of the Port or the designated
representative.
    (4) The Captain of the Port Key West may waive any of the
requirements of this section for any vessel upon finding that the
vessel or class of vessel, operational conditions, or other
circumstances are such that application of this section is unnecessary
or impractical for the purpose of port security, safety, or
environmental safety.

    Dated: June 11, 2019.
P.J. Brown,
Rear Admiral, U.S. Coast Guard, Commander, Seventh Coast Guard
District.
[FR Doc. 2019-14876 Filed 7-11-19; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: May 9, 2006 (Volume 71, Number 89)]
[Notices]
[Page 26944-26945]
[DOCID:fr09my06-69]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-332-000]

Northern Natural Gas Company; Notice of Proposed Changes in FERC
Gas Tariff

May 2, 2006.
    Take notice that on April 28, 2006, Northern Natural Gas Company
(Northern) tendered for filing to become part of it FERC Gas Tariff,
Fifth Revised Volume No. 1 First Revised Sheet No. 26, with an
effective date of June 1, 2006.
    Northern further states that copies of the filing have been mailed
to each of its customers and interested State Commissions.
    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 in
accordance with the provisions of Sec.  154.210 of the Commission's
regulations (18 CFR 154.210). 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>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-6977 Filed 5-8-06; 8:45 am]

BILLING CODE 6717-01-P