  SEQ CHAPTER \h \r 1

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

	OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

DATE:  	March 8, 2010

SUBJECT:	Cyazofamid: Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for Tolerance Petition and Proposed Section 3 Amendment Registration for Uses on Brassica (Cole) Leafy Vegetables Crop Group 5, Turnip Greens, Spinach, and Hops.

PC Code:  085651

DP Barcode:  371163

Decision No.:  420982

Registration No.:  71512-2 , 71512-3

Petition No.:  9E7615

Regulatory Action:  Sec. 3 Registration

Risk Assessment Type:  NA

Case No.:  NA

TXR No.:  NA

CAS No.:  120116-88-3

MRID No.:

40 CFR:  180.601

REVIEWER:	Amelia M. Acierto, Chemist

Risk Assessment Branch 3

Health Effects Division (7509P)

THROUGH:

		Mohsen Sahafeyan, Chemist

Thurston Morton, Chemist

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (7509P)

and

		Stephen Funk, Senior Science Advisor

		Risk Assessment Branch III

Health Effects Division (7509P)

TO:		Nancy Tsaur, Risk Assessor

Risk Assessment Branch III

Health Effects Division (7509P)

and

		Barbara Madden, RM #5

		Risk Integration, Minor Use, and Emergency Response Branch

Registration Division (7505P)

Executive Summary

ion 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.  Dietary risk assessments were performed to support a FIFRA Section 3 request to amend the registration of the fungicide cyazofamid for use on Brassica (Cole) leafy vegetables crop group 5, turnip greens, spinach, and hops.

Acute and chronic dietary (drinking water) risk assessment for cyazofamid have been conducted previously for turf and ornamentals (D332427, Susan L. Stanton, 9/14/06).  The risk estimate considered drinking water exposure only.  Subsequent dietary risk assessments were performed to support separate FIFRA Section 3 requests on carrots (D381623, A.M.Acierto, 3/5/2008) and on fruiting vegetables, okra, and grapes (D357043, Amelia M. Acierto 3/25/09).  Dietary risk estimates were determined considering exposures from food plus drinking water using the upper-bound estimated drinking water concentrations (EDWCs) for cyazofamid in surface water sources for turf grass provided by the Environmental Fate and Effects Division (EFED).  This decision was based on EFED’s determination that the highest use rate per application per season is on turf grass as compared with the use rates on various food crops (D342613, Mohammed A. Ruhman, 2/21/08 and D356836, Jose L. Melendez, 3/24/09).  Additional runs to cover the new crops (Brassica (Cole) leafy vegetables crop group 5, turnip greens, spinach, and hops) were performed by EFED with the same result that the highest EDWCs of all crops (past and present) were obtained for turf and ornamentals (surface waters) and ornamentals (ground water) (D370673, Jose L. Melendez, 3/1/2010).  As in the earlier dietary assessments, HED used the highest calculated screening EDWCs for surface water based on the 3rd modeling scenario: 136 ppb for the acute analysis and 133 ppb for the chronic analysis.  As noted previously, this approach may significantly overestimate dietary exposure to cyazofamid from drinking water; however, since estimated aggregate food and drinking water exposures using this approach are well below the acute and chronic levels of concern, additional refinements were not deemed necessary.  For both the acute and chronic analyses, the drinking water EDWC was incorporated directly as a point estimate in the DEEM analysis to assess exposure to cyazofamid from drinking water.  Drinking water was incorporated directly into the DEEM-FCID into the food categories “water, direct, all sources” and water, indirect, all sources.

The acute dietary (food plus drinking water) analysis was performed for females 13-49 years old only since an acute endpoint of concern was not identified for the general U.S. population.  The chronic dietary analyses were performed for the general U.S. population and all the population subgroups.  HED is concerned when estimated dietary risks exceed 100% of the acute or chronic population adjusted dose (aPAD and cPAD).

The acute and chronic analyses assumed that cyazofamid residues are present in all registered food commodities at tolerance levels and that 100% of all commodities are assumed treated.  Processing factors for all registered or proposed crops were set to 1, based on the results of processing studies demonstrating that residues of cyazofamid in processed commodities would not exceed the raw agricultural commodity (RAC) tolerances.

Acute Dietary Exposure Results

The unrefined acute dietary (food + water) exposure assessment was performed for females 13-49 years old only, since an acute endpoint of concern was not identified for the general U.S. population.  Based on the assumptions described above, acute dietary exposure of females 13-49 years old is well below HED’s level of concern at the 95th percentile of exposure.  Combined dietary exposure from food and drinking water is estimated at 0.012139 mg/kg/day, equivalent to 1.2% of the acute Population Adjusted Dose (aPAD).

Chronic Dietary Exposure Results

Chronic dietary exposure estimates for food and drinking water combined are also well below HED’s level of concern.  Using the DEEM-FCID software, dietary exposure for the general U.S. population is estimated at 0.004945 mg/kg/day, equivalent to <1% of the chronic Population Adjusted Dose (cPAD) and 0.011079 mg/kg/day, equivalent to 1.2% of the cPAD for infants <1 year old, the population subgroup with the highest estimated chronic dietary exposure to cyazofamid.

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 the reference dose (RfD) divided by the special Food Quality Protection Act (FQPA) Safety Factor.

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,” 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 HED dietary risk assessment for cyazofamid (D357043, Amelia M. Acierto, 3/25/09) was conducted to support the FIFRA §3 registration on fruiting vegetables, okra and grapes.  As in the 2009 dietary assessment, this current assessment incorporates drinking water directly into the dietary analyses.

II.	Food Residue Information

Residues of Concern:  The HED Metabolism Assessment Review Committee (MARC) concluded in a meeting on 2/18/04 that for the risk assessment and tolerance expression, parent and the metabolite designated as CCIM are the residues of concern for plant commodities.  The MARC also concluded that cyazofamid and the metabolites designated as CCIM, CCIM-AM and CTCA are considered to be the major residues in water and should be included in the drinking water risk assessment.  The current uses of cyazofamid fall under 40 CFR §180.6(a)(3) (i.e., there is no reasonable expectation of finite residues in livestock commodities).

Tolerances:  Tolerances have been established under 40 CFR §180.601 for the combined residues of  cyazofamid and its metabolite CCIM [4-chloro-5-(4-methylphenyl)-1H-imidazole-2-carbonitrile] in or on cucurbit vegetables, Group 9 (0.1 ppm); vegetable, fruiting, group 8 (0.40 ppm);  potato (0.02 ppm); okra (0.40 ppm), carrot, roots (0.09 ppm) and grapes (1.5 ppm). Turf and ornamentals (non-food use sites) did not require establishment of additional tolerances.

Residue Data used for the Acute and Chronic Assessments:  The unrefined acute and chronic analyses assumed that cyazofamid residues are present in/on all registered food commodities at tolerance levels and assumed 100% of all commodities are treated.  There are no processing data for brassica (Cole) leafy vegetables crop group 5, turnip greens, spinach, and hops.  The tolerance summary for cyazofamid used in the acute and chronic analyses for the proposed new uses are summarized below in Table 1.  A complete listing of the residues used in the analyses are included in Attachments 1, and 3.

Table 1.  Tolerance Summary for Cyazofamid Proposed Uses on Brassica Cole Leafy Vegetables Crop Group 5, Turnip Greens, Spinach and Hops.

Commodity	ProposedTolerance (ppm)	Recommended Tolerances (ppm) Tolerances Proposed under 40 CFR§180.601

Brassica Head and Stem Subgroup 5A 	1.2	1.2	1.2

Brassica Leafy Greens Subgroup 5B	12.0	12.0	12.0

Turnip greens	12.0	12.0	12.0

Spinach	9.0	9.0	9.0

Hops	10.0	10.0	10.0

 Drinking Water Data

Reference: Estimated Drinking Water Concentrations of Parent Cyazofamid and its Degradates of Concern CCIM, CCIM-AM and CTCA, for Use in Human Health Risk Assessment: New Uses on Brassica (Cole) Leafy Vegetables & Turnip Greens (Crop Group 5), Spinach, and Hops; Jose L. Melendez, D370673, March 1, 2010.

The above memorandum from EFED is a drinking waters assessment (DWA) that presents the EDWCs for parent cyazofamid, and the degradates CCIM, CCIM-AM and CTCA for use in an FQPA human health risk assessment. Cyazofamid fungicide and/or its degradates may reach both surface and groundwater under some conditions.  The degradates’ EDWCs were modeled individually (as opposed to the use of the total residue approach).  This was done because sufficient data were available on the degradates to model them individually (although some assumptions were made, see below).  It is noted that DWAs were previously issued as follows:

Summary of Cyazofamid Drinking Water Exposure Assessments

Date	DP Barcode	Uses included

4/28/04	301099	Cucurbits, potatoes and tomatoes

9/6/06	319466	Turf and Ornamentals

3/5/08	342613	Carrots

3/24/09	356836	Fruiting vegetables + okra, and grapes (East of the Rocky mountains)

This DWA builds largely upon the previous assessments.  Additional runs were performed to cover the new crops; the highest EDWCs of all crops (past and present) were obtained for turf and ornamentals (surface waters) and ornamentals (ground water).  The screening-level surface water and ground water EDWCs were obtained using the tier 2 linked aquatic models PRZM/ EXAMS and the tier 1 aquatic model SCI-GROW, respectively.  EDWCs are summarized in Table 2 for three scenarios as follows:

1st scenario: the parent is applied at the maximum rate;

2nd scenario: the degradates CCIM and CCIM-AM (and CTCA) are applied at the parent-molar equivalent amounts, spreading the application rate through the degradates, according to the molecular ratios and the adjusted maximum percentages of the degradates observed in the environmental fate studies; and

3rd scenario: the terminal degradate, CTCA, is applied assuming application of 100% molar conversion of the parent to the degradate.

Based on the results presented in Table 2 below and a time-line of exposure, the surface water acute EDWC is 38.2 ppb (equal to the Parent “14.362 ppb” + CCIM “17.106 ppb” + CCIM-AM “6.699 ppb”).  CTCA is not included in the surface water acute EDWC because it is not expected to be present in this time frame. The surface water non-cancer chronic is 133.5 ppb and the cancer chronic is 77.3 ppb (equal to the value for the terminal degradate, CTCA). For ground water, the EDWC is 2.18 ppb, which is suitable for acute and chronic exposures (equal to the value for the terminal degradate, CTCA).

Table 2. Maxima of surface and ground water EDWCs for cyazofamid and its relevant major degradates.  Turf and ornamentals use pattern, previously reported in D319466 (dated 9/6/06).

Scenario	Chemical	Surface water EDWCs (ppb)	Ground water EDWC (ppb)

Acute	Chronic “Non-Cancer”	Chronic “Cancer”

	1st  Scenario	Cyazofamid	14.362	0.377	0.279	0.01180

2nd  Scenario	CCIM	17.106	12.094	10.600	0.00061

	CCIM-AM	6.699	6.312	3.611	0.00270

3rd  Scenario 	CTCA	136.242	133.458	77.270	2.180

                           EDWCs	38.2	133.5	77.3	2.18

The above stated values represent upper-bound estimates of the parent, individual degradates and/or terminal degradate concentrations that might be found in surface water and groundwater due to the use of cyazofamid on turf and ornamentals.  EFED emphasizes that this is a screening level analysis and additional refinements could be made if needed.

Typically, HED uses the higher of the surface or groundwater estimates for each duration when assessing dietary risk.  Therefore, although CTCA is not expected to be found in the acute time frame of exposure, HED will continue to use the EDWC which includes CTCA (136 ppb). This approach may significantly overestimate dietary exposure to cyazofamid from drinking water, however, since estimated aggregate food and drinking water exposures using this approach are well below the acute and chronic levels of concern, additional refinements were not deemed necessary.

M-FCID™ Program and Consumption Information

Cyazofamid 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 assessments, 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.

V.	Toxicological Information

The toxicology database for cyazofamid with regard to the acute and chronic reference doses (RfDs) remain unchanged.  The rationale for toxicity endpoint selection was discussed in detail in the most recent human health risk assessment document (D356837, N. Tsaur, 5/5/20009) and will not be repeated here.  However, the doses and toxicological endpoints selected for dietary risk assessments are summarized in Table 3.

.

Table 3.  Summary of Cyazofamid Toxicological Doses and Endpoints for Dietary Risk Assessment.

Exposure

Scenario

Dose Used in Risk Assessment, UF

FQPA SF and Level of Concern for Risk Assessment

Study and Toxicological Effects

Acute Dietary

(Females 13-49 years of age)

NOAEL = 100 mg/kg

UF = 100

Acute RfD = 1.0 mg/kg

FQPA SF = 1X

aPAD = acute RfD

              FQPA SF

= 1.0 mg/kg

Rat Prenatal Developmental Toxicity (MRID 45408933)

LOAEL = 1,000 mg/kg based on developmental toxicity findings of increased incidence of bent ribs.

Acute Dietary

(General population including infants and children)

NOAEL = NA

UF = NA

Acute RfD = NA

FQPA SF =  NA

aPAD = acute RfD

              FQPA SF

= NA

No adverse effects were observed which could be attributed to a single-dose exposure.

Chronic Dietary

(All populations)

NOAEL= 94.8 mg/kg/day

UF = 100

Chronic RfD = 0.95

 mg/kg/day

FQPA SF = 1X

cPAD = chronic RfD

               FQPA SF

= 0.95 mg/kg/day

18-Month Mouse Oral Carcinogenicity (MRID 45408932)

LOAEL = 985 mg/kg/day based on increased skin lesions.

UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no-observed-adverse-effect-level, LOAEL = lowest-observed-adverse-effect-level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose, NA = Not Applicable

VI.	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 acute exposure results are reported in Tables 4 for females 13-49 only.  The chronic results reported in Table 5 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.

Results of Acute Dietary Exposure Analysis

The Tier 1 acute dietary (food + drinking water) exposure assessment was performed for females 13-49 years old only, since an acute endpoint of concern was not identified for the general population.  Based on the assumptions described above in sections II and III, acute dietary exposure of females 13-49 years old is well below HED’s level of concern (i.e., <100% of the aPAD of 1.0 mg/kg).  The combined dietary exposure from food and drinking water is estimated at 0.012139 mg/kg/day (equivalent to 1.2% of the aPAD), at the 95th percentile of exposure, the appropriate regulatory statistic for Tier 1 dietary assessments as shown in Table 4.

Table 4.  Results of Acute Dietary Exposure Analysis for Food and Drinking Water at the 95th Percentile of Exposure using DEEM FCID

Population Subgroup	aPAD (mg/kg/day)	95th Percentile	99th Percentile 99.9th Percentile

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

Females 13-49 years old 	1	0.012139	1.2	0.024480	2.45	0.059739	5.97

Results of Chronic Dietary Exposure Analysis

-FCID™ software are well below HED’s level of concern for the general U.S. population and each of the population subgroups.  Dietary exposure was estimated at 0.004945 mg/kg/day for the U.S. population (<1% of the cPAD) and 0.011079 mg/kg/day (1.2% of the cPAD) for the most highly exposed population subgroup (infants <1 year old).  The estimated exposures/risks for food and drinking water are summarized in Table 5 for all populations.

Table 5.  Results of Chronic Dietary Exposure Analysis for Food and Drinking Water

Population Subgroup	    Exposure

(mg/kg/day)	% cPAD

General U.S. Population	0.004945	<1

All Infants (< 1 year old)1	0.011079	1.2

Children 1-2 years old	0.010749	1

Children 3-5 years old	0.008556	<1

Children 6-12 years old	0.004916	<1

Youth 13-19 years old	0.003393	<1

Adults 20-49 years old	0.004351	<1

Adults 50+ years old	0.004884	<1

Females 13-49 years old	0.004302	<1

 1The population subgroup with the highest estimated chronic dietary (food + drinking water)

  exposure and  risk is indicated by bold text.

     .

VII.	Characterization of Inputs/Outputs

These acute and chronic dietary exposure and risk estimates are conservative since they assume that 100% of crops are treated with cyazofamid and that residues are present at tolerance levels.  In addition, drinking water exposure estimates were based on screening level estimates generated by the PRZM-EXAMS model.  Dietary exposure estimates could be refined through the use of anticipated residues and percent crop treated data, as well as refined estimated drinking water concentrations.  However, since estimated exposures and risks using conservative assumptions are well below HED’s level of concern, such refinement is not warranted.

VIII.	Conclusions

These unrefined, Tier 1 dietary exposure analyses using DEEM-FCID™ indicate that acute and chronic dietary exposures to cyazofamid from food and drinking water are well below HED’s level of concern for this pesticide.  The estimated acute exposure of females 13-49 years old, the only population subgroup of concern for acute exposure, represents 1.2% of the aPAD at the 95th percentile of exposure.  Estimated chronic dietary exposures are less than or equal to 1.2% of the cPAD for the general U.S. population and all population subgroups.

IX.		List of Attachments

	Acute Food + Drinking Water Input File

	Acute Food + Drinking Water Results File

	Chronic Food + Drinking Water Input File

	Chronic Food + Drinking Water Results File

Chronic Food + Drinking Water Input File

U.S. Environmental Protection Agency                           Ver. 2.00

DEEM-FCID Chronic analysis for CYAZOFAMID                    1994-98 data

Residue file: C:\Documents and Settings\aacierto\Desktop\DEEM-FCID Files\DEEM2010\Chronic cyazofamid food+water.R98     Adjust. #2 NOT used

Analysis Date 03-16-2010        Residue file dated: 03-16-2010/13:48:52/8

Reference dose (RfD) = 0.95  (NOEL) = 94.8 mg/kg bw/day

Comment:Drinking Water using CTCA Drinking Water estimate (scenario #3)

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

Food Crop                                       Residue       Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)

                                                             #1         #2

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

09020210 9B   Balsam pear                        0.100000   1.000      1.000

05010610 5A   Broccoli                           1.200000   1.000      1.000

05010611 5A   Broccoli-babyfood                  1.200000   1.000      1.000

05010620 5A   Broccoli, Chinese                  1.200000   1.000      1.000

05020630 5B   Broccoli raab                     12.000000   1.000      1.000

05010640 5A   Brussels sprouts                   1.200000   1.000      1.000

05010690 5A   Cabbage                            1.200000   1.000      1.000

05020700 5B   Cabbage, Chinese, bok choy        12.000000   1.000      1.000

05010710 5A   Cabbage, Chinese, napa             1.200000   1.000      1.000

05010720 5A   Cabbage, Chinese, mustard          1.200000   1.000      1.000

09010750 9A   Cantaloupe                         0.100000   1.000      1.000

01010780 1AB  Carrot                             0.090000   1.000      1.000

01010781 1AB  Carrot-babyfood                    0.090000   1.000      1.000

09010800 9A   Casaba                             0.100000   1.000      1.000

05010830 5A   Cauliflower                        1.200000   1.000      1.000

09020880 9B   Chayote, fruit                     0.100000   1.000      1.000

09021020 9B   Chinese waxgourd                   0.100000   1.000      1.000

05021170 5B   Collards                          12.000000   1.000      1.000

09021350 9B   Cucumber                           0.100000   1.000      1.000

95001750 O    Grape                              1.500000   1.000      1.000

95001760 O    Grape, juice                       1.500000   1.000      1.000

95001761 O    Grape, juice-babyfood              1.500000   1.000      1.000

95001770 O    Grape, leaves                      1.500000   1.000      1.000

95001780 O    Grape, raisin                      1.500000   1.000      1.000

95001790 O    Grape, wine and sherry             1.500000   1.000      1.000

09011870 9A   Honeydew melon                     0.100000   1.000      1.000

95001880 O    Hop                               10.000000   1.000      1.000

05021940 5B   Kale                              12.000000   1.000      1.000

05011960 5A   Kohlrabi                           1.200000   1.000      1.000

05022290 5B   Mustard greens                    12.000000   1.000      1.000

08002340 8    Okra                               0.400000   1.000      1.000

08002700 8    Pepper, bell                       0.400000   1.000      1.000

08002701 8    Pepper, bell-babyfood              0.400000   1.000      1.000

08002710 8    Pepper, bell, dried                0.400000   1.000      1.000

08002711 8    Pepper, bell, dried-babyfood       0.400000   1.000      1.000

08002720 8    Pepper, nonbell                    0.400000   1.000      1.000

08002721 8    Pepper, nonbell-babyfood           0.400000   1.000      1.000

08002730 8    Pepper, nonbell, dried             0.400000   1.000      1.000

01032960 1C   Potato, chips                      0.020000   1.000      1.000

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

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

01032980 1C   Potato, flour                      0.020000   1.000      1.000

01032981 1C   Potato, flour-babyfood             0.020000   1.000      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

09023080 9B   Pumpkin                            0.100000   1.000      1.000

09023090 9B   Pumpkin, seed                      0.100000   1.000      1.000

05023180 5B   Rape greens                       12.000000   1.000      1.000

04013550 4A   Spinach                            9.000000   1.000      1.000

09023560 9B   Squash, summer                     0.100000   1.000      1.000

09023561 9B   Squash, summer-babyfood            0.100000   1.000      1.000

09023570 9B   Squash, winter                     0.100000   1.000      1.000

09023571 9B   Squash, winter-babyfood            0.100000   1.000      1.000

08003740 8    Tomatillo                          0.400000   1.000      1.000

08003750 8    Tomato                             0.400000   1.000      1.000

08003751 8    Tomato-babyfood                    0.400000   1.000      1.000

08003760 8    Tomato, paste                      0.400000   1.000      1.000

08003761 8    Tomato, paste-babyfood             0.400000   1.000      1.000

08003770 8    Tomato, puree                      0.400000   1.000      1.000

08003771 8    Tomato, puree-babyfood             0.400000   1.000      1.000

08003780 8    Tomato, dried                      0.400000   1.000      1.000

08003781 8    Tomato, dried-babyfood             0.400000   1.000      1.000

08003790 8    Tomato, juice                      0.400000   1.000      1.000

95003800 O    Tomato, Tree                       0.200000   1.000      1.000

05023890 5B   Turnip, greens                    12.000000   1.000      1.000

86010000 O    Water, direct, all sources         0.133000   1.000      1.000

86020000 O    Water, indirect, all sources       0.133000   1.000      1.000

09013990 9A   Watermelon                         0.100000   1.000      1.000

09014000 9A   Watermelon, juice                  0.100000   1.000      1.000

Chronic Food + Drinking Water Results File

U.S. Environmental Protection Agency                                Ver. 2.00

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

Residue file name: C:\Documents and Settings\aacierto\Desktop\DEEM-FCID Files\DEEM2010\Chronic cyazofamid food+water.R98

                                             Adjustment factor #2 NOT used.

Analysis Date 03-16-2010/13:52:31  Residue file dated: 03-16-2010/13:48:52/8

Reference dose (RfD, Chronic) = .95 mg/kg bw/day

NOEL (Chronic) = 94.8 mg/kg bw/day

COMMENT 1: Drinking Water using CTCA Drinking Water estimate (scenario #3)

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg       Margin of   Percent

           Subgroup                       body wt/day   Exposure 1/  of RfD

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

U.S. Population (total)                     0.004945       19,170        0.5%

U.S. Population (spring season)             0.004835       19,607        0.5%

U.S. Population (summer season)             0.005231       18,123        0.6%

U.S. Population (autumn season)             0.004869       19,469        0.5%

U.S. Population (winter season)             0.004838       19,595        0.5%

Northeast region                            0.004930       19,231        0.5%

Midwest region                              0.004722       20,075        0.5%

Southern region                             0.004802       19,743        0.5%

Western region                              0.005426       17,470        0.6%

Hispanics                                   0.004836       19,603        0.5%

Non-hispanic whites                         0.004649       20,390        0.5%

Non-hispanic blacks                         0.006007       15,781        0.6%

Non-hisp/non-white/non-black                0.007056       13,436        0.7%

All infants (< 1 year)                      0.011079        8,557        1.2%

Nursing infants                             0.004345       21,817        0.5%

Non-nursing infants                         0.013634        6,953        1.4%

Children 1-6  yrs                           0.008929       10,617        0.9%

Children 7-12 yrs                           0.004649       20,394        0.5%

Females 13-19 (not preg or nursing)         0.003240       29,256        0.3%

Females 20+ (not preg or nursing)           0.004777       19,844        0.5%

Females 13-50 yrs                           0.004422       21,440        0.5%

Females 13+ (preg/not nursing)              0.003590       26,403        0.4%

Females 13+ (nursing)                       0.005594       16,945        0.6%

Males 13-19 yrs                             0.003526       26,884        0.4%

Males 20+ yrs                               0.004303       22,034        0.5%

Seniors 55+                                 0.004900       19,347        0.5%

Children 1-2 yrs                            0.010749        8,819        1.1%

Children 3-5 yrs                            0.008556       11,081        0.9%

Children 6-12 yrs                           0.004916       19,283        0.5%

Youth 13-19 yrs                             0.003393       27,936        0.4%

Adults 20-49 yrs                            0.004351       21,789        0.5%

Adults 50+ yrs                              0.004884       19,411        0.5%

Females 13-49 yrs                           0.004302       22,034        0.5%

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

Acute Food + Drinking Water Input File

U.S. Environmental Protection Agency                           Ver. 2.02

DEEM-FCID Acute analysis for CYAZOFAMID

Residue file name: C:\Documents and Settings\aacierto\Desktop\DEEM-FCID Files\DEEM2010\acute cyazofamid food+water.R98

Analysis Date 03-16-2010        Residue file dated: 03-16-2010/13:34:40/8

Reference dose: aRfD = 1 mg/kg bw/day  NOEL = 100 mg/kg bw/day

Comment: Drinking Water using CTCA Drinking Water estimate (scenario #3)

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Food Name                         (ppm)       #1    #2

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

09020210 9B   Balsam pear                        0.100000   1.000  1.000

05010610 5A   Broccoli                           1.200000   1.000  1.000

05010611 5A   Broccoli-babyfood                  1.200000   1.000  1.000

05010620 5A   Broccoli, Chinese                  1.200000   1.000  1.000

05020630 5B   Broccoli raab                     12.000000   1.000  1.000

05010640 5A   Brussels sprouts                   1.200000   1.000  1.000

05010690 5A   Cabbage                            1.200000   1.000  1.000

05020700 5B   Cabbage, Chinese, bok choy        12.000000   1.000  1.000

05010710 5A   Cabbage, Chinese, napa             1.200000   1.000  1.000

05010720 5A   Cabbage, Chinese, mustard          1.200000   1.000  1.000

09010750 9A   Cantaloupe                         0.100000   1.000  1.000

01010780 1AB  Carrot                             0.090000   1.000  1.000

01010781 1AB  Carrot-babyfood                    0.090000   1.000  1.000

09010800 9A   Casaba                             0.100000   1.000  1.000

05010830 5A   Cauliflower                        1.200000   1.000  1.000

09020880 9B   Chayote, fruit                     0.100000   1.000  1.000

09021020 9B   Chinese waxgourd                   0.100000   1.000  1.000

05021170 5B   Collards                          12.000000   1.000  1.000

09021350 9B   Cucumber                           0.100000   1.000  1.000

08001480 8    Eggplant                           0.400000   1.000  1.000

95001750 O    Grape                              1.500000   1.000  1.000

95001760 O    Grape, juice                       1.500000   1.000  1.000

95001761 O    Grape, juice-babyfood              1.500000   1.000  1.000

95001770 O    Grape, leaves                      1.500000   1.000  1.000

95001780 O    Grape, raisin                      1.500000   1.000  1.000

95001790 O    Grape, wine and sherry             1.500000   1.000  1.000

09011870 9A   Honeydew melon                     0.100000   1.000  1.000

95001880 O    Hop                               10.000000   1.000  1.000

05021940 5B   Kale                              12.000000   1.000  1.000

05011960 5A   Kohlrabi                           1.200000   1.000  1.000

05022290 5B   Mustard greens                    12.000000   1.000  1.000

08002340 8    Okra                               0.400000   1.000  1.000

08002700 8    Pepper, bell                       0.400000   1.000  1.000

08002701 8    Pepper, bell-babyfood              0.400000   1.000  1.000

08002710 8    Pepper, bell, dried                0.400000   1.000  1.000

08002711 8    Pepper, bell, dried-babyfood       0.400000   1.000  1.000

08002720 8    Pepper, nonbell                    0.400000   1.000  1.000

08002721 8    Pepper, nonbell-babyfood           0.400000   1.000  1.000

08002730 8    Pepper, nonbell, dried             0.400000   1.000  1.000

01032960 1C   Potato, chips                      0.020000   1.000  1.000

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

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

01032980 1C   Potato, flour                      0.020000   1.000  1.000

01032981 1C   Potato, flour-babyfood             0.020000   1.000  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

09023080 9B   Pumpkin                            0.100000   1.000  1.000

09023090 9B   Pumpkin, seed                      0.100000   1.000  1.000

05023180 5B   Rape greens                       12.000000   1.000  1.000

04013550 4A   Spinach                            9.000000   1.000  1.000

09023560 9B   Squash, summer                     0.100000   1.000  1.000

09023561 9B   Squash, summer-babyfood            0.100000   1.000  1.000

09023570 9B   Squash, winter                     0.100000   1.000  1.000

09023571 9B   Squash, winter-babyfood            0.100000   1.000  1.000

08003740 8    Tomatillo                          0.400000   1.000  1.000

08003750 8    Tomato                             0.400000   1.000  1.000

08003751 8    Tomato-babyfood                    0.400000   1.000  1.000

08003760 8    Tomato, paste                      0.400000   1.000  1.000

08003761 8    Tomato, paste-babyfood             0.400000   1.000  1.000

08003770 8    Tomato, puree                      0.400000   1.000  1.000

08003771 8    Tomato, puree-babyfood             0.400000   1.000  1.000

08003780 8    Tomato, dried                      0.400000   1.000  1.000

08003781 8    Tomato, dried-babyfood             0.400000   1.000  1.000

08003790 8    Tomato, juice                      0.400000   1.000†⸱〰ര㔹〰㠳〰传††潔慭潴牔敥††††† ††††††〠㈮〰〰‰†⸱〰‰ㄠ〮〰」〵㌲㤸‰䈵 †吠牵楮Ɒ朠敲湥⁳†††††††††ㄠ⸲〰〰〰† ㄠ〮〰†⸱〰ര㘸㄰〰〰传††慗整Ⱳ搠物捥ⱴ愠汬猠 畯捲獥††††〠ㄮ㘳〰‰†⸱〰‰ㄠ〮〰

F

G

$

E

F

G

O

X

c

d

k

l

m

z

|

‚

ƒ

“

”

§

¨

©

¶

¸

¾

hg

¨

©

¿

ç

ਁ氃愀϶،̀¾

¿

Ñ

æ

ç

è

ý

"ç

è

)

G

M

O

)

I

M

t

‘

±

³

Ó

î

 O

¯

°

±

²

¸

Ã

Ò

Ó

Ô

ã

ê

í

î

@

@

„@

„Àô^„@

@

@

@

@

h

h

kd)

kdÕ

@

@

摧࿆Ã

摧࿆Ã

摧࿆Ã

摧࿆Ã

摧࿆Ã

਀

h

h

G

&

@

$

$

h

@

@

@

&

@

&

@

h

@

@

gd

h

@

@

@

@

@

@

@

@

86020000 O    Water, indirect, all sources       0.136000   1.000  1.000

09013990 9A   Watermelon                         0.100000   1.000  1.000

09014000 9A   Watermelon, juice                  0.100000   1.000  1.000

Acute Food + Drinking Water Results File

U.S. Environmental Protection Agency                                  Ver. 2.02

DEEM-FCID ACUTE Analysis for CYAZOFAMID                     (1994-98 data)

Residue file: acute cyazofamid food+water.R98 Adjustment factor #2 NOT used.

Analysis Date: 03-16-2010/13:37:03  Residue file dated: 03-16-2010/13:34:40/8

NOEL (Acute) = 100.000000 mg/kg body-wt/day

Daily totals for food and foodform consumption used.

Run Comment:"Drinking Water using CTCA Drinking Water estimate (scenario #3)"

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

Summary calculations (per capita):

      95th Percentile          99th Percentile           99.9th Percentile

 Exposure  % aRfD   MOE     Exposure  % aRfD    MOE   Exposure  % aRfD  MOE

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

U.S. Population:

0.014299    1.43    6993   0.031974    3.20    3127   0.071845   7.18   1391

Females 13-49 yrs:

0.012139    1.21    8237   0.024480    2.45    4085   0.059739   5.97   1673

Cyazofamid	Dietary Exposure and Risk Assessment	DP Number: 371163

PC Code:  085651		                				   ________________________________________________________________________ ______________

Cy穡景浡摩䐠敩慴祲䔠灸獯牵獁敳獳敭瑮उ偄丠浵敢 㩲㌠㌴㐴लउ䍐䌠摯㩥〠㔸㔶റ彟彟彟彟彟彟彟彟彟彟 彟彟彟彟彟彟彟彟彟彟彟彟彟彟彟彟彟彟彟彟彟彟彟彟 彟彟彟彟彟彟彟彟彟彟彟彟ൟ

഍഍慐敧ጠ倠䝁⁅ㄔᔶ漠–啎偍䝁卅ᐠ㘱ക഍഍


[Federal Register: November 5, 2007 (Volume 72, Number 213)]
[Notices]
[Page 62468-62469]
[DOCID:fr05no07-47]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[FFP Project 54, LLC; Project No. 12915-000]

Notice of Application Accepted for Filing and Soliciting
Comments, Motions to Intervene, and Protests

October 29, 2007.
    Take notice that the following hydroelectric applications have been
filed with the Commission and are available for public inspection:
    a. Type of Application: Preliminary Permit.
    b. Project No.: P-12915-000.
    c. Date Filed: August 6, 2007.
    d. Applicant: FFP Project 54, LLC.
    e. Name of the Project: Flora Creek Light Project.
    f. Location: The project would be located on the Mississippi River
in Cape Girardeau County, Missouri and Alexander County, Illinois. The
project uses no dam or impoundment.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicants Contact: Mr. Dan Irvin, FFP Project 54, LLC, 69
Bridge Street, Manchester, MA 01944, phone<PHONE_NUMBER>.
    i. FERC Contact: Patricia W. Gillis,<PHONE_NUMBER>.
    j. Deadline for filing comments, protests, and motions to
intervene: 60 days from the issuance date of this notice.
    All documents (original and eight copies) should be filed with:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426. Comments, protests, and
interventions may be filed electronically via the Internet in lieu of
paper; see 18 CFR 385.2001(a)(1)(iii) and the instructions on the
Commission's Web site under the ``e-Filing'' link. The Commission
strongly encourages electronic filings. Please include the project
number (P-12915-000) on any comments or motions filed.
    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 in 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 Project: The proposed project would consist of:
(1) 3100 proposed 20-kilowatt Free Flow generating units having a total
installed capacity of 62-megawatts, (2) a proposed transmission line;
and (3) appurtenant facilities. The project would have an average
annual generation of 271.56-gigawatt-hours and be sold to a local
utility.
    l. Location of Application: A copy of the application is available
for inspection and reproduction at the Commission in the 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. For
assistance, call toll-free 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy is

also available for inspection and reproduction at the address in item h
above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Competing Preliminary Permit--Anyone desiring to file a
competing application for preliminary permit for a proposed project
must submit the competing application itself, or a notice of intent to
file such an application, to the Commission on or before the specified
comment date for the particular application (see 18 CFR 4.36).
Submission of a timely notice of intent allows an interested person to
file the competing preliminary permit application no later than 30 days
after the specified comment date for the particular application. A
competing preliminary permit application must conform with 18 CFR 4.30
and 4.36.
    o. Competing Development Application--Any qualified development
applicant desiring to file a competing development application must
submit to the Commission, on or before a specified comment date for the
particular application, either a competing development application or a
notice of intent to file such an application. Submission of a timely
notice of intent to file a development application allows an interested
person to file the competing application no later than 120 days after
the specified comment date for the particular application. A competing
license application must conform with 18 CFR 4.30 and 4.36.
    p. Notice of Intent--A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit, if such an application may be filed, either a preliminary
permit application or a development application (specify which type of
application). A notice of intent must be served on the applicant(s)
named in this public notice.
    q. Proposed Scope of Studies Under Permit--A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work proposed under the
preliminary permit would include economic analysis, preparation of
preliminary engineering plans, and a study of environmental impacts.
Based on the results of these studies, the Applicant would decide
whether to proceed with the preparation of a development application to
construct and operate the project.
    r. 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. 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.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See 18 CFR 385.2001 (a)(1)(iii) and
the instructions on the Commission's Web site at http://www.ferc.gov

under the ``e-Filing'' link.

    s. Filing and Service of Responsive Documents--Any filings must
bear in all capital letters the title ``COMMENTS'', ``NOTICE OF INTENT
TO FILE COMPETING APPLICATION'', ``COMPETING APPLICATION'',
``PROTEST'', and ``MOTION TO INTERVENE'', as applicable, and the
Project Number of the particular application to which the filing
refers. Any of the above-named documents must be filed by providing the
original and the number of copies provided by the Commission's
regulations to: The Secretary, Federal Energy Regulatory Commission,
888 First Street, NE., Washington, DC 20426. An additional copy must be
sent to Director, Division of Hydropower Administration and Compliance,
Federal Energy Regulatory Commission, at the above-mentioned address. A
copy of any notice of intent, competing application or motion to
intervene must also be served upon each representative of the Applicant
specified in the particular application.
    t. Agency Comments--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. E7-21654 Filed 11-2-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 150 (Tuesday, August 5, 2014)]
[Proposed Rules]
[Pages 45393-45395]
[FR Doc No: 2014-18492]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R08-OAR-2011-0100; FRL-9914-64-Region 8]

Approval and Promulgation of Air Quality Implementation Plans;
Montana; Revisions to the Administrative Rules of Montana--Air Quality,
Subchapter 7, Exclusion for De Minimis Changes

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: Environmental Protection Agency (EPA) is proposing to correct
final rules pertaining to the State of Montana's State Implementation
Plan (SIP). On February 13, 2012, EPA took final action to partially
approve and partially disapprove SIP revisions and new rules as
submitted by the State of Montana on June 25, 2010 and May 28, 2003.
EPA subsequently discovered errors in our February 13, 2012 final
action related to the ``incorporation by reference'' materials and the
associated regulatory text that inadvertently reversed portions of our
July 8, 2011 final action. EPA is proposing to correct those errors
with today's action; and we are only seeking comments on these
corrections. This action is being taken under section 110 of the Clean
Air Act (CAA).

DATES: Written comments must be received on or before September 4,
2014.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R08-
OAR-2011-0100, by one of the following methods:
     http://www.regulations.gov. Follow the on-line
instructions for submitting comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER> (please alert the individual listed in
the FOR FURTHER INFORMATION CONTACT if you are faxing comments).
     Mail: Director, Air Program, Environmental Protection
Agency (EPA), Region 8, Mail Code 8P-AR, 1595 Wynkoop Street, Denver,
Colorado 80202-1129.
     Hand Delivery: Director, Air Program, Environmental
Protection Agency (EPA), Region 8, Mail Code 8P-AR, 1595 Wynkoop
Street, Denver, Colorado 80202-1129. Such deliveries are only accepted
Monday through Friday, 8:00 a.m. to 4:30 p.m., excluding Federal
holidays. Special arrangements should be made for deliveries of boxed
information.
    Instructions: Direct your comments to Docket EPA-R08-OAR-2011-0100.
EPA's policy is that all comments received will be included in the
public docket without change and may be made available online at http://www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through http://www.regulations.gov or
email. The http://www.regulations.gov Web site is an ``anonymous
access'' system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an email comment directly to EPA, without going through http://www.regulations.gov your email address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional instructions on submitting comments, go to
Section I. General Information of the SUPPLEMENTARY INFORMATION section
of this document.

    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Air Program,
Environmental Protection Agency (EPA), Region 8, 1595 Wynkoop Street,
Denver, Colorado 80202-1129. EPA requests that if at all possible, you
contact the individual listed in the FOR FURTHER INFORMATION CONTACT
section to view the hard copy of the docket. You may view the hard copy
of the docket Monday through Friday, 8:00 a.m. to 4:00 p.m., excluding
federal holidays.

FOR FURTHER INFORMATION CONTACT: Jaslyn Dobrahner, Air Program, EPA,
Region 8, Mail Code 8P-AR, 1595 Wynkoop, Denver, Colorado 80202-1129,
(303) 312-6252<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Definitions

    For the purpose of this document, we are giving meaning to certain
words or initials as follows:
    (i) The words or initials Act or CAA mean or refer to the Clean Air
Act, unless the context indicates otherwise.
    (ii) The words EPA, we, us or our mean or refer to the United
States Environmental Protection Agency.
    (iii) The initials SIP mean or refer to State Implementation Plan.
    (iv) The words State or Montana mean the State of Montana, unless
the context indicates otherwise.

Table of Contents

I. General Information
II. Background
III. What action is EPA taking?
IV. Statutory and Executive Orders Review

I. General Information

What should I consider as I prepare my comments for EPA?

    1. Submitting Confidential Business Information (CBI). Do not
submit CBI to EPA through http://www.regulations.gov or email. Clearly
mark the part or all of the information that you claim to be CBI. For
CBI information on a disk or CD ROM that you mail to EPA, mark the
outside of the disk or CD ROM as CBI and then identify electronically
within the disk or CD ROM the specific information that is claimed as
CBI. In addition to one complete version of the comment that includes
information claimed as CBI, a copy of the comment that does not contain
the information claimed as CBI must be submitted for inclusion in the
public docket. Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date, and
page number);
     Follow directions and organize your comments;
     Explain why you agree or disagree;
     Suggest alternatives and substitute language for your
requested changes;
     Describe any assumptions and provide any technical
information and/or data that you used;
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced;
     Provide specific examples to illustrate your concerns, and
suggest alternatives;
     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats; and
     Make sure to submit your comments by the comment period
deadline identified.
    3. Scope of comments. Although EPA is including the entire
regulatory text in this action and the associated proposed
incorporation by reference materials (with proposed corrections) so
that the public can see the corrections, EPA is only seeking comment on
the proposed corrections that are described in this document. Our prior
documents provided an opportunity for the public to review and comment
on our partial approval and partial disapproval actions regarding these
Montana State Implementation Plan regulations. Therefore, we will only
address comments regarding the proposed corrections described in this
document.

II. Background

    In our rule published on February 13, 2012 (77 FR 7531), EPA took
final action to partially approve and partially disapprove SIP
revisions and new rules as submitted by the State of Montana on June
25, 2010 and May 28, 2003. On page 7534, third column, under the
regulatory text in 40 CFR 52.1370(c)(72)(i) Incorporation by reference,
paragraph (A), EPA inadvertently incorporated by reference all of
Administrative Rules of Montana (ARM), 17.8.740, Definitions. We are
proposing to amend the regulatory text in 40 CFR 51.1370(c)(72)(i)(A)
to specify that EPA only approved the phrase ``, except when a permit
is not required under ARM 17.8.745'' in ARM 17.8.740(8)(a) and the
phrase, ``, except as provided in ARM 17.8.745'' in ARM 17.8.740(8)(c).
Therefore, we propose that the regulatory text in 40 CFR
51.1370(c)(72)(i)(A) read as follows: ``Administrative Rules of
Montana, 17.8.740, Definitions, ARM 17.8.740(8)(a) and (c),
respectively, the phrases `, except when a permit is not required under
ARM 17.8.745' and `, except as provided in ARM 17.8.745'; 17.8.743,
Montana Air Quality Permits--When Required, (except for the phrase in
17.8.743(1)(b), `asphalt concrete plants, mineral crushers, and', and
17.8.743(1)(c)); and 17.8.764, Administrative Amendment to Permit,
effective 12/27/2002.''
    This proposed correction is consistent with: (1) The preamble of
our February 13, 2012 final rule (77 FR 7531, 7534); and (2) the July
8, 2011 final rule (76 FR 40237) and associated regulatory text found
in 40 CFR 52.1370(c)(70)(i)(B)(2) where we disapproved the phrase in
ARM 17.8.740(2) ``includes a reasonable period of time for startup and
shakedown and'' and the definitions in ARM 17.8.740(10) and (14),
``Negligible risk to the public health, safety, and welfare and to the
environment'' and ``Routine Maintenance, repair, or replacement,''
respectively. We also confirm that our approval of the phrase ``unless
the increase meets the criteria in ARM 17.8.745 for a de minimis change
not requiring a permit, or'' in 17.8.764(1)(b) of our July 8, 2011
final rule (76 FR 40237) is accurate, while the same phrase in the
preamble of the July 8, 2011 and February 13, 2012 final rules is
incorrect.
    In this action, EPA is also proposing to correct the associated IBR
material for our February 13, 2012 (77 FR 7531) rule by striking out
the aforementioned phrases (ARM 17.8.740(2), ARM 17.8.743(1)(c)) and
two definitions (ARM 17.8.740(10), ARM 17.8.740(14)) that were
inadvertently included in the IBR SIP material from the State's May 28,
2003 submittal; and the proposed corrected IBR material appears in the
docket for this action.
    For more detailed information regarding these February 13, 2012 and
July 8, 2011 actions, see 77 FR 7531 and 76 FR 40237.

III. What action is EPA taking?

    EPA is proposing to amend the text in 40 CFR 51.1370(c)(72)(i)(A)
to read as follows: ``Administrative Rules of Montana, 17.8.740,
Definitions, ARM

17.8.740(8)(a) and (c), respectively, the phrases `, except when a
permit is not required under ARM 17.8.745' and `, except as provided in
ARM 17.8.74'; 17.8.743, Montana Air Quality Permits--When Required,
(except for the phrase in 17.8.743(1)(b), `asphalt concrete plants,
mineral crushers, and', and 17.8.743(1)(c)); and 17.8.764,
Administrative Amendment to Permit, effective 12/27/2002.''

IV. Statutory and Executive Orders Review

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
federal regulations (42 U.S.C. 7410(k), 40 CFR 52.02(a)). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
proposed action merely approves some state law as meeting federal
requirements and disapproves other state law because it does not meet
federal requirements; this proposed action does not impose additional
requirements beyond those imposed by state law. For that reason, this
proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999); is not an
economically significant regulatory action based on health or safety
risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and,
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have Tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on Tribal governments or preempt Tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Authority: 42 U.S.C. 7401 et seq.

    Date: July 15, 2014.
Shaun L. McGrath,
Regional Administrator, Region 8.
[FR Doc. 2014-18492 Filed 8-4-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)]
[Proposed Rules]
[Pages 7481-7483]
[FR Doc No: 2016-02814]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

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

Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 /
Proposed Rules

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket Number USCG-2015-1126]
RIN 1625-AA08

Special Local Regulation; Chesapeake Bay, Between Sandy Point and
Kent Island, MD

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes to establish special local
regulations for certain waters of the Chesapeake Bay. This action is
necessary to provide for the safety of life on these navigable waters
located between Sandy Point, Anne Arundel County, MD and Kent Island,
Queen Anne's County, MD, during a paddling event on May 14, 2016. This
proposed rulemaking would prohibit persons and vessels from being in
the regulated area unless authorized by the Captain of the Port
Baltimore or Coast Guard Patrol Commander. We invite your comments on
this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before March 14, 2016.

ADDRESSES: You may submit comments identified by docket number USCG-
2015-1126 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 Mr. Ronald Houck, U.S. Coast Guard
Sector Baltimore, MD; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
E.O. Executive order
FR Federal Register
NPRM Notice of proposed rulemaking
Pub. L. Public Law
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    On December 28, 2015, ABC Events, Inc. notified the Coast Guard
that it will be conducting the Bay Bridge Paddle from 8 a.m. until noon
on May 14, 2016, to both showcase the kayak and stand up paddle board
water sport for intermediate and elite paddlers, and benefit the
Annapolis Chapter of the Foundation for Community Betterment and the
Maryland Chapter of the Special Olympics. The paddle race is to be held
under and between the north and south spans of the William P. Lane, Jr.
(US-50/301) Memorial Bridges, located between Sandy Point, Anne Arundel
County, MD and Kent Island, Queen Anne's County, MD. Elite paddlers
will depart Sandy Point and proceed easterly along a 4.2-mile course
toward Kent Island, turn around upon reaching a point near Kent Island,
and proceed back to Sandy Point. Intermediate paddlers will depart
Sandy Point and proceed easterly along the same 4.2-mile course toward
Kent Island, however, they will turn around upon reaching the half way
point (2.1 miles), and proceed back to Sandy Point. Hazards from the
paddle race include event numerous event participants crossing
designated shipping channels and interfering with vessels intending to
operate within those channels. The COTP Baltimore has determined that
potential hazards associated with the paddle race would be a safety
concern for anyone intending to operate within certain waters of the
Chesapeake Bay between Sandy Point and Kent Island, MD.
    The purpose of this rulemaking is to protect event participants,
spectators and transiting vessels on certain waters of the Chesapeake
Bay before, during, and after the scheduled event.
    The Coast Guard proposes this rulemaking under authority in 33
U.S.C. 1233, which authorize the Coast Guard to establish and define
special local regulations.

III. Discussion of Proposed Rule

    The COTP Baltimore proposes to establish special local regulations
from 7:30 a.m. until 12:30 p.m. on May 14, 2016, and, if necessary due
to inclement weather, from 7:30 a.m. until 12:30 p.m. on May 15, 2016.
The regulated area would cover all navigable waters of the Chesapeake
Bay between and adjacent to the spans of the William P. Lane Jr.
Memorial Bridges from shoreline to shoreline, bounded to the north by a
line drawn parallel and 500 yards north of the north bridge span that
originates from the western shoreline at latitude 39[deg]00'36'' N.,
longitude 076[deg]23'05'' W. and thence eastward to the eastern
shoreline at latitude 38[deg]59'14'' N., longitude 076[deg]20'00'' W.,
and bounded to the south by a line drawn parallel and 500 yards south
of the south bridge span that originates from the western shoreline at
latitude 39[deg]00'16'' N., longitude 076[deg]24'30'' W. and thence
eastward to the eastern shoreline at latitude 38[deg]58'38.5'' N.,
longitude 076[deg]20'06'' W. The duration of the regulated area is
intended to ensure the safety of vessels and these navigable waters
before, during, and after the scheduled 8 a.m. until noon paddle event.
Except for Bay Bridge Paddle participants, no vessel or person would be
permitted to enter the regulated area without obtaining permission from
the COTP Baltimore 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 (E.O.s) related to rulemaking. Below we summarize
our analyses based on a number of these statutes and E.O.s, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    E.O.s 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.
E.O. 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 E.O. 12866. Accordingly,

the NPRM has not been reviewed by the Office of Management and Budget.
    This regulatory action determination is based on the size and
duration of the regulated area, which would impact a small designated
area of the Chesapeake Bay for 5 hours. The Coast Guard would issue a
Broadcast Notice to Mariners via VHF-FM marine channel 16 about the
status of the regulated area. Moreover, the rule would allow vessels to
seek permission to enter the regulated area, and vessel traffic would
be able to safely transit the regulated area once the Coast Guard
Patrol Commander deems it safe to do so.

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 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 E.O. 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 E.O. 13132.
    Also, this proposed rule does not have tribal implications under
E.O. 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 above.

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
implementation of regulations within 33 CFR part 100 applicable to
organized marine events on the navigable waters of the United States
that could negatively impact the safety of waterway users and shore
side activities in the event area lasting for 5 hours. The category of
water activities includes but is not limited to sail boat regattas,
boat parades, power boat racing, swimming events, crew racing, canoe
and sail board racing. 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 a temporary Sec.  100.35-T05-1126 to read as follows:

Sec.  100.501-T05-1126  Special Local Regulation; Chesapeake Bay,
between Sandy Point and Kent Island, MD.

    (a) Regulated area. The following location is a regulated area: All
navigable waters of the Chesapeake Bay between and adjacent to the
spans of the William P. Lane Jr. Memorial Bridges from shoreline to
shoreline, bounded to the north by a line drawn parallel and 500 yards
north of the north bridge span that originates from the western
shoreline at latitude 39[deg]00'36'' N., longitude 076[deg]23'05'' W.,
and thence eastward to the eastern shoreline at latitude 38[deg]59'14''
N., longitude 076[deg]20'00'' W., and bounded to the south by a line
drawn parallel and 500 yards south of the south bridge span that
originates from the western shoreline at latitude 39[deg]00'16'' N.,
longitude 076[deg]24'30'' W., and thence eastward to the eastern
shoreline at latitude 38[deg]58'38.5'' N., longitude 076[deg]20'06'' W.
All coordinates reference Datum NAD 1983.
    (b) Definitions. (1) Captain of the Port Baltimore means the
Commander, U.S. Coast Guard Sector Baltimore, Maryland or any Coast
Guard commissioned, warrant or petty officer who has been authorized by
the Captain of the Port to act on his behalf.
    (2) Coast Guard Patrol Commander means a commissioned, warrant, or
petty officer of the U.S. Coast Guard who has been designated by the
Commander, Coast Guard Sector Baltimore.
    (3) Official Patrol means any vessel assigned or approved by
Commander, Coast Guard Sector Baltimore with a commissioned, warrant,
or petty officer on board and displaying a Coast Guard ensign.
    (4) Participant means all persons and vessels participating in the
Bay Bridge Paddle event under the auspices of the Marine Event Permit
issued to the event sponsor and approved by Commander, Coast Guard
Sector Baltimore.
    (c) Special local regulations: (1) The Coast Guard Patrol Commander
may forbid and control the movement of all vessels and persons,
including event participants, in the regulated area. When hailed or
signaled by an official patrol, a vessel or person in the regulated
area shall immediately comply with the directions given. Failure to do
so may result in expulsion from the area, citation for failure to
comply, or both. The Coast Guard Patrol Commander may terminate the
event, or the operation of any support vessel participating in the
event, at any time it is deemed necessary for the protection of life or
property.
    (2) Except for participants and vessels already at berth, mooring,
or anchor, all persons and vessels within the regulated area at the
time it is implemented are to depart the regulated area.
    (3) Persons desiring to transit the regulated area must first
obtain authorization from the Captain of the Port Baltimore or Coast
Guard Patrol Commander. Prior to the enforcement period, to seek
permission to transit the area, the Captain of the Port Baltimore can
be contacted at telephone number<PHONE_NUMBER> or on Marine Band Radio,
VHF-FM channel 16 (156.8 MHz). During the enforcement period, to seek
permission to transit the area, the Coast Guard Patrol Commander can be
contacted on Marine Band Radio, VHF-FM channel 16 (156.8 MHz) for
direction.
    (4) The Coast Guard may be assisted in the patrol and enforcement
of the regulated area by other Federal, State, and local agencies. The
Coast Guard Patrol Commander and official patrol vessels enforcing this
regulated area can be contacted on marine band radio VHF-FM channel 16
(156.8 MHz) and channel 22A (157.1 MHz).
    (5) The Coast Guard will publish a notice in the Fifth Coast Guard
District Local Notice to Mariners and issue a marine information
broadcast on VHF-FM marine band radio announcing specific event date
and times.
    (d) Enforcement period. This section will be enforced from 7:30
a.m. until 12:30 p.m. on May 14, 2016, and if necessary, due to
inclement weather, from 7:30 a.m. until 12:30 p.m. on May 15, 2016.

     Dated: January 29, 2016.
Lonnie P. Harrison, Jr.,
Captain, U.S. Coast Guard, Captain of the Port Baltimore.
[FR Doc. 2016-02814 Filed 2-11-16; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 185 (Friday, September 23, 2016)]
[Notices]
[Pages 65653-65655]
[FR Doc No: 2016-22936]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1399]

Procedures for Evaluating Appearance Issues and Granting
Authorizations for Participation in Food and Drug Administration
Advisory Committees; Draft Guidance for the Public, Food and Drug
Administration Advisory Committee Members, and Food and Drug
Administration Staff; Availability; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA) is extending the
comment period for the notice that

appeared in the Federal Register of June 29, 2016. In the notice, FDA
requested comments on ``Procedures for Evaluating Appearance Issues and
Granting Authorizations for Participation in FDA Advisory Committees;
Guidance for the Public, FDA Advisory Committee Members, and FDA
Staff'' and on whether FDA should request that each advisory committee
member, who receives an authorization from FDA on an appearance issue
so that they may participate in an advisory committee meeting,
voluntarily publicly disclose the authorization. The Agency is taking
this action due to errors displayed on the FDA Web site pertaining to
this guidance.

DATES: FDA is extending the comment period for the notice that
published on June 29, 2016 (81 FR 42363) by an additional 60 days.
Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comments on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by November 26, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov
.Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2016-D-1399 for ``Procedures for Evaluating Appearance Issues and
Granting Authorizations for Participation in FDA Advisory Committees;
Guidance for the Public, FDA Advisory Committee Members, and FDA
Staff.'' Received comments will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
http://www.regulations.gov or at the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for a single hard copy of the draft
guidance entitled ``Procedures for Evaluating Appearance Issues and
Granting Authorizations for Participation in FDA Advisory Committees;
Guidance for the Public, FDA Advisory Committee Members, and FDA
Staff'' to the Advisory Committee Oversight and Management Staff,
Office of Special Medical Programs, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Janine M. Morris, Office of Special
Medical Products, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5114, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 29, 2016, FDA published a notice
with a 90-day comment period to request comments on the draft guidance
and public disclosure of authorizations described in this guidance.
    The Agency has decided to allow for a 60-day extension of the
comment period for the notice. The FDA Web site that displayed the
posting of this guidance indicated, in error, that the guidance was not
open for comment. The Agency was concerned that individuals visiting
the FDA Web site and interested in providing comments may not have
known that the document was available for comment under the docket
found at http://www.regulations.gov.
    FDA is therefore extending the comment period for the notice for an
additional 60 days, until November 26, 2016. The Agency believes that a
60-day extension allows adequate time for interested persons to submit
comments without compromising timely publication of the final guidance.

II. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the Internet at either http:/
/

www.fda.gov/RegulatoryInformation/Guidances/ucm122045.htm or http://www.regulations.gov.

    Dated: September 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22936 Filed 9-22-16; 8:45 am]
 BILLING CODE 4164-01-P