                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C. 20460

                                                                      OFFICE OF
                                                            CHEMICAL SAFETY AND
                            		POLLUTION PREVENTION

MEMORANDUM

DATE:  	24-MAR-2011

SUBJECT:	Saflufenacil.  Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessment for the Section 3 Registration Action on Vegetable, Legume, Subgroup 6C, pea and bean (except soybean); Soybean; Rapeseed Subgroup 20A; Sunflower Subgroup 20B; and Cottonseed Subgroup 20C.

PC Code:  118203
DP Barcodes:  D381976, D384350
Decision Nos.:  436793, 437943
Registration No.:  7969-278
Petition Nos.:  0F7744, 0F7766
Regulatory Action:  Sec. 3 Registration
Risk Assessment Type:  Dietary
Case No.:  NA
TXR No.:  NA
CAS No.:  372137-35-4
MRID No.:  NA
40 CFR:  §180.649

FROM:	George F. Kramer, Ph.D., Senior Chemist
            Risk Assessment Branch 1 (RAB1)/Health Effects Division (HED; 7509P)

THROUGH:	David E. Hrdy, Senior Biologist
            Dennis McNeilly, Chemist
            Dietary Exposure Science Advisory Council (DESAC)
            HED (7509P)

                  and

            Dana M. Vogel, Branch Chief
            RAB1/HED (7509P)

TO:		George F. Kramer, Ph.D., Risk Assessor
		RAB1/HED (7509P)

            and

      Kathryn Montague/Susan Stanton, PM Team 23
      Registration Division (RD) (7505P)

Executive Summary

Acute and chronic dietary-exposure and risk assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID[(TM)], Version 2.03) which use food consumption data from the U.S. Department of Agriculture's Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.  These analyses were performed to support a Section 3 request for the use of saflufenacil in/on cotton, dry bean, dry pea, soybean, and canola.

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

The unrefined acute analysis assumed 100% crop treated (CT), DEEM[(TM)] 7.81 default concentration factors, and tolerance-level residues for all commodities [except for cottonseed; sunflower subgroup 20B; soybean, seed; vegetable, legume, subgroup 6C, pea and bean (except soybean); and rapeseed subgroup 20A  -  see Section II for more details].  Drinking water was incorporated directly into the dietary assessment using the concentration for ground water generated by the Tier II Pesticide Root Zone Model Ground Water (PRZM GW).  The acute dietary risk estimates (food + water) are <1% of the acute population-adjusted dose (aPAD) for the general U.S. population and <1% of the aPAD for the most highly exposed population subgroup (all infants (<1 year old) and are thus below HED's level of concern (<100% aPAD).

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

The unrefined chronic analysis assumed 100% CT, DEEM[(TM)] 7.81 default concentration factors, and tolerance-level residues for all commodities [except for cottonseed; sunflower subgroup 20B; soybean, seed; vegetable, legume, subgroup 6C, pea and bean (except soybean); and rapeseed subgroup 20A  -  see Section II for more details].  Drinking water was incorporated directly into the dietary assessment using the concentration for ground water generated by PRZM GW.  The chronic dietary risk estimates (food + water) 9.2% of the chronic population-adjusted dose (cPAD) for the general U.S. population and 30% of the cPAD for the most highly exposed population subgroup (all infants (<1 year old) and are thus below HED's level of concern (<100% cPAD).

Cancer Dietary (Food and Drinking Water) Exposure Results and Characterization

Saflufenacil is classified as "not likely carcinogenic to humans."  Therefore, cancer risk is not a concern for this chemical.

I.  Introduction

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

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

The most recent dietary exposure risk assessment for saflufenacil was conducted by G. Kramer (Memo, 22-JUL-2009, D364183).

II.  Residue Information

Saflufenacil Proposed and Registered Uses:

Saflufenacil is currently registered for use on legume vegetables (Crop Group 06), the foliage of legume vegetables (Crop Group 07), cereal grains (Crop Group 15), forage, fodder, and straw of cereal grains (Crop Group 16), cotton, and sunflower.  BASF has submitted a proposal to amend the established tolerances for saflufenacil on cotton, dry bean, dry pea, and soybean (PP#0F7744).  The amended tolerances on these crops are the result of the proposed harvest aid/desiccation use pattern for Sharpen[(TM)] Powered by Kixor Herbicide (EPA Reg. No. 7969-278); the currently-registered uses are for preplant application.  In addition, BASF has submitted a proposal for a new use of Sharpen[(TM)] on Oilseeds, Rapeseed Subgroup 20A as harvest aid/desiccant (PP#0F7744).

Residues of Concern:  The nature of the residue in plants, rotational crops, and livestock is adequately understood based on acceptable metabolism studies conducted on corn (preplant application), soybean (preplant and preharvest application), tomato (preplant application), rotational crops, lactating goats, and laying hens.  The HED Residues of Concern Knowledgebase Subcommittee (ROCKS) determined that residues of concern for the tolerance expression and risk assessment in plants consist of saflufenacil, M800H11, and M800H35; and that saflufenacil is the only residue of concern in livestock (Memo, B. Daiss, 1/6/09; D359645).  An additional major metabolite (M800H02) that is not included in the tolerance expression was observed in soybean seed following preharvest application.  As the structure of M800H02 is closely related to the parent compound and it is the precursor of the regulated metabolite M800H11, RAB1 concludes that M800H02 is a residue of concern for risk-assessment purposes in crops following post-emergence treatment.

Table 1.  Summary of Metabolites and Degradates to be included in the Risk Assessment.
Matrix
Residues included in Risk Assessment
Residues included in Tolerance Expression
Plants
Primary Crops (preplant application)
Saflufenacil + M800H11, M800H35
Saflufenacil + M800H11, M800H35

Primary Crops (preharvest application)
Saflufenacil + M800H11, M800H02, M800H35

Rotational Crops
Saflufenacil + M800H11, M800H35

Livestock
Ruminants
Saflufenacil
Saflufenacil

Poultry

Drinking Water
Saflufenacil + M800H01, M800H02, M800H07, M800H08, M800H15, M800H22, Product 8
Not Applicable

Established Tolerances:  Permanent tolerances for "saflufenacil, including its metabolites and degradates, in or on the commodities in the table below.  Compliance with the tolerance levels specified below is to be determined by measuring only the sum of saflufenacil, 2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-(trifluoromethyl)-1(2H)-pyrimidinyl]-4-fluoro-N-[[methyl(1-methylethyl)amino]sulfonyl]benzamide, and its metabolites N-[2-chloro-5-(2,6-dioxo-4-(trifluoromethyl)-3,6-dihydro-1(2H)-pyrimidinyl)-4-fluorobenzoyl]-N'-isopropylsulfamide and N-[4-chloro-2-fluoro-5-({[(isopropylamino)sulfonyl]amino}carbonyl)phenyl]urea, calculated as the stoichiometric equivalent of saflufenacil" are currently established under 40 CFR §180.649(a)(1) for residues on citrus fruit (Crop Group 10), pome fruit (Crop Group 11), stone fruit (Crop Group 12), grape, tree nuts (Crop Group 14), legume vegetables (Crop Group 06), the foliage of legume vegetables (Crop Group 07), cereal grains (Crop Group 15), forage, fodder, and straw of cereal grains (Crop Group 16), cotton, and sunflower.  Additionally, permanent tolerances for "saflufenacil, including its metabolites and degradates, in or on the commodities in the table below.  Compliance with the tolerance levels specified below is to be determined by measuring only saflufenacil, 2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-(trifluoromethyl)-1(2H)-pyrimidinyl]-4-fluoro-N-[[methyl(1-methylethyl)amino]sulfonyl]benzamide" are currently established under 40 CFR §180.649(a)(2) for residues on livestock commodities.

Recommended Tolerances:  Based on the residue chemistry data submitted with the current petitions, HED recommended for establishment of the following tolerances (G. Kramer, 3/24/11; DP# 381129):

Table 2.  Tolerance Summary for Saflufenacil.
Commodity
                          Recommended Tolerance (ppm)
Cotton, gin byproducts
                                     0.45
Cottonseed Subgroup 20C
                                     0.20
Sunflower Subgroup 20B
                                      1.0
Pea, vines
                                      17
Grain, aspirated fractions
                                      10
Soybean, hulls
                                     0.50
Soybean, seed
                                     0.10
Pea and bean, dried shelled, except soybean, subgroup 6C
                                     0.30
Rapeseed Subgroup 20A
                                     0.45
Cattle, liver
                                      2.5
Cattle, meat byproducts, except liver
                                     0.05
Goat, liver
                                      2.5
Goat, meat byproducts, except liver
                                     0.05
Sheep, liver
                                      2.5
Sheep, meat byproducts, except liver
                                     0.05
Horse, liver
                                      2.5
Horse, meat byproducts, except liver
                                     0.05

Residue Data used for Acute and Chronic Assessments:

The acute and chronic assessments were based on the assumption of tolerance-level residues for all commodities, except for cottonseed; sunflower subgroup 20B; soybean, seed; vegetable, legume, subgroup 6C, pea and bean (except soybean); and rapeseed subgroup 20A.  For these crops, residues were also based on the recommended tolerances; however, a correction factor was applied to the tolerance level to account for the M800H02 metabolite included in the risk assessment as a result of preharvest uses.  The additional metabolite, M800H02, was observed in the metabolism studies of preharvest-treated soybean seed, comprising 26.3% of the total radioactive residues (G. Kramer, 3/24/11; DP# 381129).  Since the toxicity of the M800H02 is expected to be comparable to the parent compound, it was included in the risk assessment for preharvest uses, but not in the tolerance expression.  To account for this additional toxicity exposure, the recommended tolerance level was multiplied by a correction factor of 1.7x, where 1.7 = (Metabolites in Risk Assessment)/(Metabolites in Tolerance Expression).

1.7 =	(Saflufenacil + M800H11 + M800H02 + M800H35)/(Saflufenacil + M800H11 + M800H35) =
     (26.1% + 10.9% + 26.3% + 0%)/(26.1% + 10.9% + 0%)

Therefore, in the acute and chronic assessments, a residue of 0.34 ppm was used for cottonseed; a residue of 1.7 ppm was used for sunflower subgroup 20B; a residue of 0.17 ppm was used for soybean, seed; a residue of 0.51 ppm was used for vegetable, legume, subgroup 6C, pea and bean (except soybean); and a residue of 0.76 ppm was used for rapeseed subgroup 20A (see Table 3).

Table 3.  Corrected Residues Used in the Chronic Assessment.
Crop Group and/or Commodity
Tolerance (ppm)[2]
Corrected Residue Used in Dietary Assessments[1]
Cottonseed Subgroup 20C
                                     0.20
                                     0.34
Sunflower Subgroup 20B
                                      1.0
                                      1.7
Soybean, seed
                                     0.10
                                     0.17
Vegetable, Legume, Subgroup 6C, pea and bean (except soybean)
                                     0.30
                                     0.51
Rapeseed Subgroup 20A
                                     0.45
                                     0.76
[1] Tolerance level residues were corrected to account for the addition of the M800H02 metabolite which was observed in the metabolism studies of preharvest-treated soybean seed.  The recommended tolerance level was multiplied by a correction factor of 1.7x, where 1.7 = (Metabolites in Risk Assessment)/(Metabolites in Tolerance Expression).
[2] These are HED-recommended tolerances based on Petitions 0F7744 and 0F7766.

%CT Information:  The chronic assessment was based on the assumption of 100% CT for all commodities.

Processing Factors:  DEEM[(TM)] 7.81 default processing factors were used for all processed commodities (where provided).

III.  Drinking Water Data

The Estimated Drinking Water Concentrations (EDWCs) used in the dietary exposure risk assessment were provided by the Environmental Fate and Effects Division (EFED) in a memorandum dated 04/15/09 (Memo, G. Orrick; DP# 349860).  Water residues were incorporated directly into the DEEM-FCID[(TM)] into the food categories "water, direct, all sources" and "water, indirect, all sources."

Screening EDWCs (Table 3) of saflufenacil were generated with FQPA Index Reservoir Screening Tool (FIRST) for surface water and with PRZM GW for ground water.  Modeled application rates represent the maximum use patterns of five proposed end-use labels with selected uses on row crops, orchard trees, vineyards, tree plantations, and non-agricultural areas.  Remaining model input parameters were chosen according to current guidance (USEPA, 2002).  EDWCs reflect exposure to saflufenacil and all degradates of concern in drinking water (Table 1).

Table 3.  Tiered EDWCs for Proposed Saflufenacil Uses.

Source (Tier: Model)
                       1-in-10-year Peak Exposure (ppb)
                    1-in-10-year Annual Mean Exposure (ppb)
Surface water (Tier I: FIRST)
                                     37.3
                                     23.8
Ground water (Tier II: PRZM GW)
                                      180
                           (used in acute analysis)
                                      173
                          (used in chronic analysis)

IV.  DEEM-FCID[(TM)] Program and Consumption Information

Saflufenacil acute and chronic dietary exposure assessments were conducted using DEEM-FCID[(TM)], Version 2.03, which incorporates consumption data from USDA's 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" (i.e., apple pie) are linked to EPA-defined food commodities (i.e. 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 years old, children 3-5 years old, children 6-12 years old, youth 13-19 years old, females 13-49 years old, adults 20-49 years old, and adults 50+ years old.

For chronic dietary exposure assessment, an estimate of the residue level in each food or food-form (i.e., 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

Table 4.  Summary of Toxicological Doses and Endpoints for saflufenacil for Use in Dietary Human Health Risk Assessments.
Exposure/
Scenario
Point of Departure
Uncertainty/
FQPA SFs
RfD, PAD, LOC for Risk Assessment
Study and Toxicological Effects
Acute Dietary (General Population, including Infants and Children)
NOAEL = 500 mg/kg/day
UFA = 10X
UFH = 10X

FQPA SF = 1X
Acute RfD = 5.0 mg/kg

aPAD = 5.0 mg/kg
Acute Neurotoxicity Study.
NOAEL = 500 (M) and 2000 (F) mg/kg/day.
LOAEL was 2000 mg/kg/day (males) based on the decreased motor activity representing mild and transient systemic toxicity.
LOAEL was not established for females.
Chronic Dietary (All Populations)
NOAEL = 4.6 mg/kg/day
UFA = 10X
UFH = 10X

FQPA SF = 1X
Chronic RfD = 0.046 mg/kg/day

cPAD = 0.046 mg/kg/day
Chronic/Carcinogenicity (mouse).
NOAEL = 4.6 mg/kg bw/d (males) and 18.9 mg/kg bw/d (females).
LOAELs = 13.8 mg/kg bw/d (males) and 38.1 mg/kg bw/day (females) based on decreased red blood cells, hemoglobin, and hematocrit and porphyria observed in the satellite group.
Cancer (oral, dermal, inhalation)
Classification:  Not carcinogenic based on the lack of tumors in the mouse and rat carcinogenicity studies and lack of mutagenicity.
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.  LOC = level of concern.

VI.  Results/Discussion

For acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD.  The DEEM-FCID[(TM)] analyses estimate the dietary exposure of the U.S. population and various population subgroups.  The results reported in Table 3 are for the general U.S. population, all infants (<1 year old), children 1-2 years old, children 3-5 years old, children 6-12 years old, youth 13-19 years old, females 13-49 years old, adults 20-49 years old, and adults 50+ years old.

Results of Acute and Chronic Dietary Exposure Analyses

The acute dietary risk for food and drinking water utilized (<1% of the aPAD for the U.S. population.  The acute dietary risk for the highest exposed population subgroup, all infants (<1 year old), is <1% of the aPAD.

The chronic dietary risk for food and drinking water utilized 9.2% of the cPAD for the U.S. population.  The chronic dietary risk for the highest exposed population subgroup, all infants (<1 year old), is 30% of the cPAD.

The results of the acute and chronic dietary exposure analyses are reported in Table 5.

 Table 5.  Summary of Dietary (Food and Drinking Water) Exposure Risk for Saflufenacil.
                              Population Subgroup
                                 Acute Dietary
                              (95[th] Percentile)
                                Chronic Dietary

                          Dietary Exposure (mg/kg/day)
                                     % aPAD
                                Dietary Exposure
                                  (mg/kg/day)
                                     % cPAD
 General U.S. Population
                                    0.010370
                                     <1
                                    0.004219
                                      9.2
 All Infants (<1 year old)
                                    0.038353
                                     <1
                                    0.013999
                                       30
 Children 1-2 years old
                                    0.017102
                                     <1
                                    0.007234
                                       16
 Children 3-5 years old
                                    0.015406
                                     <1
                                    0.006506
                                       14
 Children 6-12 years old
                                    0.010475
                                     <1
                                    0.004370
                                       10
 Youth 13-19 years old
                                    0.008429
                                     <1
                                    0.003159
                                      6.9
 Adults 20-49 years old
                                    0.009246
                                     <1
                                    0.003811
                                      8.3
 Adults 50+ years old
                                    0.008373
                                     <1
                                    0.003945
                                      8.6
 Females 13-49 years old
                                    0.009310
                                     <1
                                    0.003793
                                      8.2
 *The values for the highest exposed population for each type of risk assessment are bolded.

 VII.  Characterization of Inputs/Outputs

These acute and chronic dietary exposure and risk estimates are conservative since they assumed 100% CT, DEEM[(TM)] 7.81 default concentration factors, and tolerance-level or higher residues and were based on screening level estimates of drinking water concentrations generated by PRZM GW.  They could be further refined through the use of anticipated residues, empirical processing factors and % CT data, as well as refined drinking water estimates.

 VIII.  Conclusions

The acute and chronic dietary exposure and risk analyses using DEEM-FCID[(TM)] indicates that dietary risks to saflufenacil from food and drinking water are well below HED's levels of concern for this pesticide.  Estimated acute dietary risks are <1% of the aPAD for the general U.S. population and all population subgroups and estimated chronic dietary risks are <=30% of the cPAD for the general U.S. population and all population subgroups.

 IX.  List of Attachments

 Acute Food plus Water Residue Input File.
 Acute Results File.
 Chronic Food plus Water Residue Input File.
 Chronic Results File.

cc:  G. Kramer (RAB1)
RDI:  DESAC (1/14/11)
G.F. Kramer:S10957:PY-S:(703)305-5079:7509P:RAB1
Acute Food plus Water Residue Input File
Filename: C:\Documents and Settings\gkramer\My Documents\Gk\##Saflufenacil-new\Saflufenacil_Acute.R98
Chemical: Saflufenacil
RfD(Chronic): .046 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day
RfD(Acute): 5 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day
Date created/last modified: 01-20-2011/12:33:55/8          Program ver. 2.03
--------------------------------------------------------------------------------
  EPA    Crop                                   Def Res     Adj.Factors   Comment
  Code   Grp  Commodity Name                    (ppm)       #1    #2
-------- ---- -------------------------------  ----------  ------ ------  -------
95001280 O    Cottonseed, oil                    0.340000   1.000  1.000
95001281 O    Cottonseed, oil-babyfood           0.340000   1.000  1.000
95001750 O    Grape                              0.030000   1.000  1.000
95001760 O    Grape, juice                       0.030000   1.200  1.000
95001761 O    Grape, juice-babyfood              0.030000   1.200  1.000
95001770 O    Grape, leaves                      0.030000   1.000  1.000
95001780 O    Grape, raisin                      0.030000   4.300  1.000
95001790 O    Grape, wine and sherry             0.030000   1.000  1.000
95003360 O    Sesame, seed                       0.760000   1.000  1.000
95003361 O    Sesame, seed-babyfood              0.760000   1.000  1.000
95003370 O    Sesame, oil                        0.760000   1.000  1.000
95003371 O    Sesame, oil-babyfood               0.760000   1.000  1.000
86010000 O    Water, direct, all sources         0.180000   1.000  1.000
86020000 O    Water, indirect, all sources       0.180000   1.000  1.000
21000440 M    Beef, meat                         0.010000   1.000  1.000
21000441 M    Beef, meat-babyfood                0.010000   1.000  1.000
21000450 M    Beef, meat, dried                  0.010000   1.920  1.000
21000460 M    Beef, meat byproducts              0.050000   1.000  1.000
21000461 M    Beef, meat byproducts-babyfood     0.050000   1.000  1.000
21000470 M    Beef, fat                          0.010000   1.000  1.000
21000471 M    Beef,fat-babyfood                  0.010000   1.000  1.000
21000480 M    Beef, kidney                       0.050000   1.000  1.000
21000490 M    Beef, liver                        2.500000   1.000  1.000
21000491 M    Beef, liver-babyfood               2.500000   1.000  1.000
23001690 M    Goat, meat                         0.010000   1.000  1.000
23001700 M    Goat, meat byproducts              0.050000   1.000  1.000
23001710 M    Goat, fat                          0.010000   1.000  1.000
23001720 M    Goat, kidney                       0.050000   1.000  1.000
23001730 M    Goat, liver                        2.500000   1.000  1.000
24001890 M    Horse, meat                        0.010000   1.000  1.000
25002900 M    Pork, meat                         0.010000   1.000  1.000
25002901 M    Pork, meat-babyfood                0.010000   1.000  1.000
25002910 M    Pork, skin                         0.010000   1.000  1.000
25002920 M    Pork, meat byproducts              0.020000   1.000  1.000
25002921 M    Pork, meat byproducts-babyfood     0.020000   1.000  1.000
25002930 M    Pork, fat                          0.010000   1.000  1.000
25002931 M    Pork, fat-babyfood                 0.010000   1.000  1.000
25002940 M    Pork, kidney                       0.010000   1.000  1.000
25002950 M    Pork, liver                        0.800000   1.000  1.000
29003120 M    Rabbit, meat                       0.010000   1.000  1.000
26003390 M    Sheep, meat                        0.010000   1.000  1.000
26003391 M    Sheep, meat-babyfood               0.010000   1.000  1.000
26003400 M    Sheep, meat byproducts             0.050000   1.000  1.000
26003410 M    Sheep, fat                         0.010000   1.000  1.000
26003411 M    Sheep, fat-babyfood                0.010000   1.000  1.000
26003420 M    Sheep, kidney                      0.050000   1.000  1.000
26003430 M    Sheep, liver                       2.500000   1.000  1.000
27002220 D    Milk, fat                          0.010000   1.000  1.000
27002221 D    Milk, fat - baby food/infant for   0.010000   1.000  1.000
27012230 D    Milk, nonfat solids                0.010000   1.000  1.000
27012231 D    Milk, nonfat solids-baby food/in   0.010000   1.000  1.000
27022240 D    Milk, water                        0.010000   1.000  1.000
27022241 D    Milk, water-babyfood/infant form   0.010000   1.000  1.000
27032251 D    Milk, sugar (lactose)-baby food/   0.010000   1.000  1.000
06030300 6C   Bean, black, seed                  0.510000   1.000  1.000
06020310 6B   Bean, broad, succulent             0.030000   1.000  1.000
06030320 6C   Bean, broad, seed                  0.510000   1.000  1.000
06020330 6B   Bean, cowpea, succulent            0.030000   1.000  1.000
06030340 6C   Bean, cowpea, seed                 0.510000   1.000  1.000
06030350 6C   Bean,  great northern, seed        0.510000   1.000  1.000
06030360 6C   Bean, kidney, seed                 0.510000   1.000  1.000
06020370 6B   Bean, lima, succulent              0.030000   1.000  1.000
06030380 6C   Bean, lima, seed                   0.510000   1.000  1.000
06030390 6C   Bean, mung, seed                   0.510000   1.000  1.000
06030400 6C   Bean, navy, seed                   0.510000   1.000  1.000
06030410 6C   Bean, pink, seed                   0.510000   1.000  1.000
06030420 6C   Bean, pinto, seed                  0.510000   1.000  1.000
06010430 6A   Bean, snap, succulent              0.030000   1.000  1.000
06010431 6A   Bean, snap, succulent-babyfood     0.030000   1.000  1.000
06030980 6C   Chickpea, seed                     0.510000   1.000  1.000
06030981 6C   Chickpea, seed-babyfood            0.510000   1.000  1.000
06030990 6C   Chickpea, flour                    0.510000   1.000  1.000
06031820 6C   Guar, seed                         0.510000   1.000  1.000
06031821 6C   Guar, seed-babyfood                0.510000   1.000  1.000
06032030 6C   Lentil, seed                       0.510000   1.000  1.000
06022550 6B   Pea, succulent                     0.030000   1.000  1.000
06022551 6B   Pea, succulent-babyfood            0.030000   1.000  1.000
06032560 6C   Pea, dry                           0.510000   1.000  1.000
06032561 6C   Pea, dry-babyfood                  0.510000   1.000  1.000
06012570 6A   Pea, edible podded, succulent      0.030000   1.000  1.000
06032580 6C   Pea, pigeon, seed                  0.510000   1.000  1.000
06022590 6B   Pea, pigeon, succulent             0.030000   1.000  1.000
06003470 6    Soybean, seed                      0.170000   1.000  1.000
06003480 6    Soybean, flour                     0.170000   1.000  1.000
06003481 6    Soybean, flour-babyfood            0.170000   1.000  1.000
06003490 6    Soybean, soy milk                  0.170000   1.000  1.000
06003491 6    Soybean, soy milk-babyfood or in   0.170000   1.000  1.000
06003500 6    Soybean, oil                       0.170000   1.000  1.000
06003501 6    Soybean, oil-babyfood              0.170000   1.000  1.000
10001060 10   Citrus citron                      0.030000   1.000  1.000
10001070 10   Citrus hybrids                     0.030000   1.000  1.000
10001080 10   Citrus, oil                        0.030000   1.000  1.000
10001800 10   Grapefruit                         0.030000   1.000  1.000
10001810 10   Grapefruit, juice                  0.030000   2.100  1.000
10001970 10   Kumquat                            0.030000   1.000  1.000
10001990 10   Lemon                              0.030000   1.000  1.000
10002000 10   Lemon, juice                       0.030000   2.000  1.000
10002001 10   Lemon, juice-babyfood              0.030000   2.000  1.000
10002010 10   Lemon, peel                        0.030000   1.000  1.000
10002060 10   Lime                               0.030000   1.000  1.000
10002070 10   Lime, juice                        0.030000   2.000  1.000
10002071 10   Lime, juice-babyfood               0.030000   2.000  1.000
10002400 10   Orange                             0.030000   1.000  1.000
10002410 10   Orange, juice                      0.030000   1.800  1.000
10002411 10   Orange, juice-babyfood             0.030000   1.800  1.000
10002420 10   Orange, peel                       0.030000   1.000  1.000
10003070 10   Pummelo                            0.030000   1.000  1.000
10003690 10   Tangerine                          0.030000   1.000  1.000
10003700 10   Tangerine, juice                   0.030000   1.000  1.000
11000070 11   Apple, fruit with peel             0.030000   1.000  1.000
11000080 11   Apple, peeled fruit                0.030000   1.000  1.000
11000081 11   Apple, peeled fruit-babyfood       0.030000   1.000  1.000
11000090 11   Apple, dried                       0.030000   8.000  1.000
11000091 11   Apple, dried-babyfood              0.030000   8.000  1.000
11000100 11   Apple, juice                       0.030000   1.300  1.000
11000101 11   Apple, juice-babyfood              0.030000   1.300  1.000
11000110 11   Apple, sauce                       0.030000   1.000  1.000
11000111 11   Apple, sauce-babyfood              0.030000   1.000  1.000
11001290 11   Crabapple                          0.030000   1.000  1.000
11002100 11   Loquat                             0.030000   1.000  1.000
11002660 11   Pear                               0.030000   1.000  1.000
11002661 11   Pear-babyfood                      0.030000   1.000  1.000
11002670 11   Pear, dried                        0.030000   6.250  1.000
11002680 11   Pear, juice                        0.030000   1.000  1.000
11002681 11   Pear, juice-babyfood               0.030000   1.000  1.000
11003100 11   Quince                             0.030000   1.000  1.000
12000120 12   Apricot                            0.030000   1.000  1.000
12000121 12   Apricot-babyfood                   0.030000   1.000  1.000
12000130 12   Apricot, dried                     0.030000   6.000  1.000
12000140 12   Apricot, juice                     0.030000   1.000  1.000
12000141 12   Apricot, juice-babyfood            0.030000   1.000  1.000
12000900 12   Cherry                             0.030000   1.000  1.000
12000901 12   Cherry-babyfood                    0.030000   1.000  1.000
12000910 12   Cherry, juice                      0.030000   1.500  1.000
12000911 12   Cherry, juice-babyfood             0.030000   1.500  1.000
12002300 12   Nectarine                          0.030000   1.000  1.000
12002600 12   Peach                              0.030000   1.000  1.000
12002601 12   Peach-babyfood                     0.030000   1.000  1.000
12002610 12   Peach, dried                       0.030000   7.000  1.000
12002611 12   Peach, dried-babyfood              0.030000   7.000  1.000
12002620 12   Peach, juice                       0.030000   1.500  1.000
12002621 12   Peach, juice-babyfood              0.030000   1.500  1.000
12002850 12   Plum                               0.030000   1.000  1.000
12002851 12   Plum-babyfood                      0.030000   1.000  1.000
12002860 12   Plum, prune, fresh                 0.030000   1.000  1.000
12002861 12   Plum, prune, fresh-babyfood        0.030000   1.000  1.000
12002870 12   Plum, prune, dried                 0.030000   5.000  1.000
12002871 12   Plum, prune, dried-babyfood        0.030000   5.000  1.000
12002880 12   Plum, prune, juice                 0.030000   1.400  1.000
12002881 12   Plum, prune, juice-babyfood        0.030000   1.400  1.000
14000030 14   Almond                             0.030000   1.000  1.000
14000031 14   Almond-babyfood                    0.030000   1.000  1.000
14000040 14   Almond, oil                        0.030000   1.000  1.000
14000041 14   Almond, oil-babyfood               0.030000   1.000  1.000
14000590 14   Brazil nut                         0.030000   1.000  1.000
14000680 14   Butternut                          0.030000   1.000  1.000
14000810 14   Cashew                             0.030000   1.000  1.000
14000920 14   Chestnut                           0.030000   1.000  1.000
14001550 14   Filbert                            0.030000   1.000  1.000
14001560 14   Filbert, oil                       0.030000   1.000  1.000
14001850 14   Hickory nut                        0.030000   1.000  1.000
14002130 14   Macadamia nut                      0.030000   1.000  1.000
14002690 14   Pecan                              0.030000   1.000  1.000
14002820 14   Pistachio                          0.030000   1.000  1.000
14003910 14   Walnut                             0.030000   1.000  1.000
15000250 15   Barley, pearled barley             0.030000   1.000  1.000
15000251 15   Barley, pearled barley-babyfood    0.030000   1.000  1.000
15000260 15   Barley, flour                      0.030000   1.000  1.000
15000261 15   Barley, flour-babyfood             0.030000   1.000  1.000
15000270 15   Barley, bran                       0.030000   1.000  1.000
15000650 15   Buckwheat                          0.030000   1.000  1.000
15000660 15   Buckwheat, flour                   0.030000   1.000  1.000
15001200 15   Corn, field, flour                 0.030000   1.000  1.000
15001201 15   Corn, field, flour-babyfood        0.030000   1.000  1.000
15001210 15   Corn, field, meal                  0.030000   1.000  1.000
15001211 15   Corn, field, meal-babyfood         0.030000   1.000  1.000
15001220 15   Corn, field, bran                  0.030000   1.000  1.000
15001230 15   Corn, field, starch                0.030000   1.000  1.000
15001231 15   Corn, field, starch-babyfood       0.030000   1.000  1.000
15001240 15   Corn, field, syrup                 0.030000   1.500  1.000
15001241 15   Corn, field, syrup-babyfood        0.030000   1.500  1.000
15001250 15   Corn, field, oil                   0.030000   1.000  1.000
15001251 15   Corn, field, oil-babyfood          0.030000   1.000  1.000
15001260 15   Corn, pop                          0.030000   1.000  1.000
15001270 15   Corn, sweet                        0.030000   1.000  1.000
15001271 15   Corn, sweet-babyfood               0.030000   1.000  1.000
15002260 15   Millet, grain                      0.030000   1.000  1.000
15002310 15   Oat, bran                          0.030000   1.000  1.000
15002320 15   Oat, flour                         0.030000   1.000  1.000
15002321 15   Oat, flour-babyfood                0.030000   1.000  1.000
15002330 15   Oat, groats/rolled oats            0.030000   1.000  1.000
15002331 15   Oat, groats/rolled oats-babyfood   0.030000   1.000  1.000
15003230 15   Rice, white                        0.030000   1.000  1.000
15003231 15   Rice, white-babyfood               0.030000   1.000  1.000
15003240 15   Rice, brown                        0.030000   1.000  1.000
15003241 15   Rice, brown-babyfood               0.030000   1.000  1.000
15003250 15   Rice, flour                        0.030000   1.000  1.000
15003251 15   Rice, flour-babyfood               0.030000   1.000  1.000
15003260 15   Rice, bran                         0.030000   1.000  1.000
15003261 15   Rice, bran-babyfood                0.030000   1.000  1.000
15003280 15   Rye, grain                         0.030000   1.000  1.000
15003290 15   Rye, flour                         0.030000   1.000  1.000
15003440 15   Sorghum, grain                     0.030000   1.000  1.000
15003450 15   Sorghum, syrup                     0.030000   1.000  1.000
15003810 15   Triticale, flour                   0.030000   1.000  1.000
15003811 15   Triticale, flour-babyfood          0.030000   1.000  1.000
15004010 15   Wheat, grain                       0.030000   1.000  1.000
15004011 15   Wheat, grain-babyfood              0.030000   1.000  1.000
15004020 15   Wheat, flour                       0.030000   1.000  1.000
15004021 15   Wheat, flour-babyfood              0.030000   1.000  1.000
15004030 15   Wheat, germ                        0.030000   1.000  1.000
15004040 15   Wheat, bran                        0.030000   1.000  1.000
15004050 15   Wild rice                          0.030000   1.000  1.000

Acute Results File.

 U.S. Environmental Protection Agency                                  Ver. 2.02
DEEM-FCID ACUTE Analysis for SAFLUFENACIL                        (1994-98 data)
Residue file: Saflufenacil_Acute.R98                  Adjustment factor #2 used.
Analysis Date: 03-18-2011/11:04:21    Residue file dated: 03-18-2011/10:49:15/8
Daily totals for food and foodform consumption used.
Run Comment: ""
===============================================================================

Summary calculations (per capita):

                    95th Percentile      99th Percentile      99.9th Percentile
                   Exposure   % aRfD    Exposure   % aRfD    Exposure   % aRfD
                  ---------- --------  ---------- --------  ---------- --------
U.S. Population:
                    0.010370     0.21    0.019013     0.38    0.037137     0.74
All infants:
                    0.038353     0.77    0.054633     1.09    0.095326     1.91
Children 1-2 yrs:
                    0.017102     0.34    0.028469     0.57    0.041000     0.82
Children 3-5 yrs:
                    0.015406     0.31    0.022944     0.46    0.039576     0.79
Children 6-12 yrs:
                    0.010475     0.21    0.017125     0.34    0.025947     0.52
Youth 13-19 yrs:
                    0.008429     0.17    0.013931     0.28    0.023366     0.47
Adults 20-49 yrs:
                    0.009246     0.18    0.015229     0.30    0.027003     0.54
Adults 50+ yrs:
                    0.008373     0.17    0.011904     0.24    0.019544     0.39
Females 13-49 yrs:
                    0.009310     0.19    0.014981     0.30    0.025430     0.51

Chronic Food plus Water Residue Input File.
 Filename: C:\Documents and Settings\gkramer\My Documents\Gk\##Saflufenacil-new\Saflufenacil_Chronic.R98
Chemical: Saflufenacil
RfD(Chronic): .046 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day
RfD(Acute): 5 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day
Date created/last modified: 03-18-2011/10:48:46/8          Program ver. 2.03
--------------------------------------------------------------------------------
  EPA    Crop                                   Def Res     Adj.Factors   Comment
  Code   Grp  Commodity Name                    (ppm)       #1    #2
-------- ---- -------------------------------  ----------  ------ ------  -------
95001280 O    Cottonseed, oil                    0.340000   1.000  1.000
95001281 O    Cottonseed, oil-babyfood           0.340000   1.000  1.000
95001750 O    Grape                              0.030000   1.000  1.000
95001760 O    Grape, juice                       0.030000   1.200  1.000
95001761 O    Grape, juice-babyfood              0.030000   1.200  1.000
95001770 O    Grape, leaves                      0.030000   1.000  1.000
95001780 O    Grape, raisin                      0.030000   4.300  1.000
95001790 O    Grape, wine and sherry             0.030000   1.000  1.000
95003360 O    Sesame, seed                       0.760000   1.000  1.000
95003361 O    Sesame, seed-babyfood              0.760000   1.000  1.000
95003370 O    Sesame, oil                        0.760000   1.000  1.000
95003371 O    Sesame, oil-babyfood               0.760000   1.000  1.000
86010000 O    Water, direct, all sources         0.173000   1.000  1.000
86020000 O    Water, indirect, all sources       0.173000   1.000  1.000
21000440 M    Beef, meat                         0.010000   1.000  1.000
21000441 M    Beef, meat-babyfood                0.010000   1.000  1.000
21000450 M    Beef, meat, dried                  0.010000   1.920  1.000
21000460 M    Beef, meat byproducts              0.050000   1.000  1.000
21000461 M    Beef, meat byproducts-babyfood     0.050000   1.000  1.000
21000470 M    Beef, fat                          0.010000   1.000  1.000
21000471 M    Beef,fat-babyfood                  0.010000   1.000  1.000
21000480 M    Beef, kidney                       0.050000   1.000  1.000
21000490 M    Beef, liver                        2.500000   1.000  1.000
21000491 M    Beef, liver-babyfood               2.500000   1.000  1.000
23001690 M    Goat, meat                         0.010000   1.000  1.000
23001700 M    Goat, meat byproducts              0.050000   1.000  1.000
23001710 M    Goat, fat                          0.010000   1.000  1.000
23001720 M    Goat, kidney                       0.050000   1.000  1.000
23001730 M    Goat, liver                        2.500000   1.000  1.000
24001890 M    Horse, meat                        0.010000   1.000  1.000
25002900 M    Pork, meat                         0.010000   1.000  1.000
25002901 M    Pork, meat-babyfood                0.010000   1.000  1.000
25002910 M    Pork, skin                         0.010000   1.000  1.000
25002920 M    Pork, meat byproducts              0.020000   1.000  1.000
25002921 M    Pork, meat byproducts-babyfood     0.020000   1.000  1.000
25002930 M    Pork, fat                          0.010000   1.000  1.000
25002931 M    Pork, fat-babyfood                 0.010000   1.000  1.000
25002940 M    Pork, kidney                       0.010000   1.000  1.000
25002950 M    Pork, liver                        0.800000   1.000  1.000
29003120 M    Rabbit, meat                       0.010000   1.000  1.000
26003390 M    Sheep, meat                        0.010000   1.000  1.000
26003391 M    Sheep, meat-babyfood               0.010000   1.000  1.000
26003400 M    Sheep, meat byproducts             0.050000   1.000  1.000
26003410 M    Sheep, fat                         0.010000   1.000  1.000
26003411 M    Sheep, fat-babyfood                0.010000   1.000  1.000
26003420 M    Sheep, kidney                      0.050000   1.000  1.000
26003430 M    Sheep, liver                       2.500000   1.000  1.000
27002220 D    Milk, fat                          0.010000   1.000  1.000
27002221 D    Milk, fat - baby food/infant for   0.010000   1.000  1.000
27012230 D    Milk, nonfat solids                0.010000   1.000  1.000
27012231 D    Milk, nonfat solids-baby food/in   0.010000   1.000  1.000
27022240 D    Milk, water                        0.010000   1.000  1.000
27022241 D    Milk, water-babyfood/infant form   0.010000   1.000  1.000
27032251 D    Milk, sugar (lactose)-baby food/   0.010000   1.000  1.000
06030300 6C   Bean, black, seed                  0.510000   1.000  1.000
06020310 6B   Bean, broad, succulent             0.030000   1.000  1.000
06030320 6C   Bean, broad, seed                  0.510000   1.000  1.000
06020330 6B   Bean, cowpea, succulent            0.030000   1.000  1.000
06030340 6C   Bean, cowpea, seed                 0.510000   1.000  1.000
06030350 6C   Bean,  great northern, seed        0.510000   1.000  1.000
06030360 6C   Bean, kidney, seed                 0.510000   1.000  1.000
06020370 6B   Bean, lima, succulent              0.030000   1.000  1.000
06030380 6C   Bean, lima, seed                   0.510000   1.000  1.000
06030390 6C   Bean, mung, seed                   0.510000   1.000  1.000
06030400 6C   Bean, navy, seed                   0.510000   1.000  1.000
06030410 6C   Bean, pink, seed                   0.510000   1.000  1.000
06030420 6C   Bean, pinto, seed                  0.510000   1.000  1.000
06010430 6A   Bean, snap, succulent              0.030000   1.000  1.000
06010431 6A   Bean, snap, succulent-babyfood     0.030000   1.000  1.000
06030980 6C   Chickpea, seed                     0.510000   1.000  1.000
06030981 6C   Chickpea, seed-babyfood            0.510000   1.000  1.000
06030990 6C   Chickpea, flour                    0.510000   1.000  1.000
06031820 6C   Guar, seed                         0.510000   1.000  1.000
06031821 6C   Guar, seed-babyfood                0.510000   1.000  1.000
06032030 6C   Lentil, seed                       0.510000   1.000  1.000
06022550 6B   Pea, succulent                     0.030000   1.000  1.000
06022551 6B   Pea, succulent-babyfood            0.030000   1.000  1.000
06032560 6C   Pea, dry                           0.510000   1.000  1.000
06032561 6C   Pea, dry-babyfood                  0.510000   1.000  1.000
06012570 6A   Pea, edible podded, succulent      0.030000   1.000  1.000
06032580 6C   Pea, pigeon, seed                  0.510000   1.000  1.000
06022590 6B   Pea, pigeon, succulent             0.030000   1.000  1.000
06003470 6    Soybean, seed                      0.170000   1.000  1.000
06003480 6    Soybean, flour                     0.170000   1.000  1.000
06003481 6    Soybean, flour-babyfood            0.170000   1.000  1.000
06003490 6    Soybean, soy milk                  0.170000   1.000  1.000
06003491 6    Soybean, soy milk-babyfood or in   0.170000   1.000  1.000
06003500 6    Soybean, oil                       0.170000   1.000  1.000
06003501 6    Soybean, oil-babyfood              0.170000   1.000  1.000
10001060 10   Citrus citron                      0.030000   1.000  1.000
10001070 10   Citrus hybrids                     0.030000   1.000  1.000
10001080 10   Citrus, oil                        0.030000   1.000  1.000
10001800 10   Grapefruit                         0.030000   1.000  1.000
10001810 10   Grapefruit, juice                  0.030000   2.100  1.000
10001970 10   Kumquat                            0.030000   1.000  1.000
10001990 10   Lemon                              0.030000   1.000  1.000
10002000 10   Lemon, juice                       0.030000   2.000  1.000
10002001 10   Lemon, juice-babyfood              0.030000   2.000  1.000
10002010 10   Lemon, peel                        0.030000   1.000  1.000
10002060 10   Lime                               0.030000   1.000  1.000
10002070 10   Lime, juice                        0.030000   2.000  1.000
10002071 10   Lime, juice-babyfood               0.030000   2.000  1.000
10002400 10   Orange                             0.030000   1.000  1.000
10002410 10   Orange, juice                      0.030000   1.800  1.000
10002411 10   Orange, juice-babyfood             0.030000   1.800  1.000
10002420 10   Orange, peel                       0.030000   1.000  1.000
10003070 10   Pummelo                            0.030000   1.000  1.000
10003690 10   Tangerine                          0.030000   1.000  1.000
10003700 10   Tangerine, juice                   0.030000   1.000  1.000
11000070 11   Apple, fruit with peel             0.030000   1.000  1.000
11000080 11   Apple, peeled fruit                0.030000   1.000  1.000
11000081 11   Apple, peeled fruit-babyfood       0.030000   1.000  1.000
11000090 11   Apple, dried                       0.030000   8.000  1.000
11000091 11   Apple, dried-babyfood              0.030000   8.000  1.000
11000100 11   Apple, juice                       0.030000   1.300  1.000
11000101 11   Apple, juice-babyfood              0.030000   1.300  1.000
11000110 11   Apple, sauce                       0.030000   1.000  1.000
11000111 11   Apple, sauce-babyfood              0.030000   1.000  1.000
11001290 11   Crabapple                          0.030000   1.000  1.000
11002100 11   Loquat                             0.030000   1.000  1.000
11002660 11   Pear                               0.030000   1.000  1.000
11002661 11   Pear-babyfood                      0.030000   1.000  1.000
11002670 11   Pear, dried                        0.030000   6.250  1.000
11002680 11   Pear, juice                        0.030000   1.000  1.000
11002681 11   Pear, juice-babyfood               0.030000   1.000  1.000
11003100 11   Quince                             0.030000   1.000  1.000
12000120 12   Apricot                            0.030000   1.000  1.000
12000121 12   Apricot-babyfood                   0.030000   1.000  1.000
12000130 12   Apricot, dried                     0.030000   6.000  1.000
12000140 12   Apricot, juice                     0.030000   1.000  1.000
12000141 12   Apricot, juice-babyfood            0.030000   1.000  1.000
12000900 12   Cherry                             0.030000   1.000  1.000
12000901 12   Cherry-babyfood                    0.030000   1.000  1.000
12000910 12   Cherry, juice                      0.030000   1.500  1.000
12000911 12   Cherry, juice-babyfood             0.030000   1.500  1.000
12002300 12   Nectarine                          0.030000   1.000  1.000
12002600 12   Peach                              0.030000   1.000  1.000
12002601 12   Peach-babyfood                     0.030000   1.000  1.000
12002610 12   Peach, dried                       0.030000   7.000  1.000
12002611 12   Peach, dried-babyfood              0.030000   7.000  1.000
12002620 12   Peach, juice                       0.030000   1.500  1.000
12002621 12   Peach, juice-babyfood              0.030000   1.500  1.000
12002850 12   Plum                               0.030000   1.000  1.000
12002851 12   Plum-babyfood                      0.030000   1.000  1.000
12002860 12   Plum, prune, fresh                 0.030000   1.000  1.000
12002861 12   Plum, prune, fresh-babyfood        0.030000   1.000  1.000
12002870 12   Plum, prune, dried                 0.030000   5.000  1.000
12002871 12   Plum, prune, dried-babyfood        0.030000   5.000  1.000
12002880 12   Plum, prune, juice                 0.030000   1.400  1.000
12002881 12   Plum, prune, juice-babyfood        0.030000   1.400  1.000
14000030 14   Almond                             0.030000   1.000  1.000
14000031 14   Almond-babyfood                    0.030000   1.000  1.000
14000040 14   Almond, oil                        0.030000   1.000  1.000
14000041 14   Almond, oil-babyfood               0.030000   1.000  1.000
14000590 14   Brazil nut                         0.030000   1.000  1.000
14000680 14   Butternut                          0.030000   1.000  1.000
14000810 14   Cashew                             0.030000   1.000  1.000
14000920 14   Chestnut                           0.030000   1.000  1.000
14001550 14   Filbert                            0.030000   1.000  1.000
14001560 14   Filbert, oil                       0.030000   1.000  1.000
14001850 14   Hickory nut                        0.030000   1.000  1.000
14002130 14   Macadamia nut                      0.030000   1.000  1.000
14002690 14   Pecan                              0.030000   1.000  1.000
14002820 14   Pistachio                          0.030000   1.000  1.000
14003910 14   Walnut                             0.030000   1.000  1.000
15000250 15   Barley, pearled barley             0.030000   1.000  1.000
15000251 15   Barley, pearled barley-babyfood    0.030000   1.000  1.000
15000260 15   Barley, flour                      0.030000   1.000  1.000
15000261 15   Barley, flour-babyfood             0.030000   1.000  1.000
15000270 15   Barley, bran                       0.030000   1.000  1.000
15000650 15   Buckwheat                          0.030000   1.000  1.000
15000660 15   Buckwheat, flour                   0.030000   1.000  1.000
15001200 15   Corn, field, flour                 0.030000   1.000  1.000
15001201 15   Corn, field, flour-babyfood        0.030000   1.000  1.000
15001210 15   Corn, field, meal                  0.030000   1.000  1.000
15001211 15   Corn, field, meal-babyfood         0.030000   1.000  1.000
15001220 15   Corn, field, bran                  0.030000   1.000  1.000
15001230 15   Corn, field, starch                0.030000   1.000  1.000
15001231 15   Corn, field, starch-babyfood       0.030000   1.000  1.000
15001240 15   Corn, field, syrup                 0.030000   1.500  1.000
15001241 15   Corn, field, syrup-babyfood        0.030000   1.500  1.000
15001250 15   Corn, field, oil                   0.030000   1.000  1.000
15001251 15   Corn, field, oil-babyfood          0.030000   1.000  1.000
15001260 15   Corn, pop                          0.030000   1.000  1.000
15001270 15   Corn, sweet                        0.030000   1.000  1.000
15001271 15   Corn, sweet-babyfood               0.030000   1.000  1.000
15002260 15   Millet, grain                      0.030000   1.000  1.000
15002310 15   Oat, bran                          0.030000   1.000  1.000
15002320 15   Oat, flour                         0.030000   1.000  1.000
15002321 15   Oat, flour-babyfood                0.030000   1.000  1.000
15002330 15   Oat, groats/rolled oats            0.030000   1.000  1.000
15002331 15   Oat, groats/rolled oats-babyfood   0.030000   1.000  1.000
15003230 15   Rice, white                        0.030000   1.000  1.000
15003231 15   Rice, white-babyfood               0.030000   1.000  1.000
15003240 15   Rice, brown                        0.030000   1.000  1.000
15003241 15   Rice, brown-babyfood               0.030000   1.000  1.000
15003250 15   Rice, flour                        0.030000   1.000  1.000
15003251 15   Rice, flour-babyfood               0.030000   1.000  1.000
15003260 15   Rice, bran                         0.030000   1.000  1.000
15003261 15   Rice, bran-babyfood                0.030000   1.000  1.000
15003280 15   Rye, grain                         0.030000   1.000  1.000
15003290 15   Rye, flour                         0.030000   1.000  1.000
15003440 15   Sorghum, grain                     0.030000   1.000  1.000
15003450 15   Sorghum, syrup                     0.030000   1.000  1.000
15003810 15   Triticale, flour                   0.030000   1.000  1.000
15003811 15   Triticale, flour-babyfood          0.030000   1.000  1.000
15004010 15   Wheat, grain                       0.030000   1.000  1.000
15004011 15   Wheat, grain-babyfood              0.030000   1.000  1.000
15004020 15   Wheat, flour                       0.030000   1.000  1.000
15004021 15   Wheat, flour-babyfood              0.030000   1.000  1.000
15004030 15   Wheat, germ                        0.030000   1.000  1.000
15004040 15   Wheat, bran                        0.030000   1.000  1.000
15004050 15   Wild rice                          0.030000   1.000  1.000

Chronic Results File.

U.S. Environmental Protection Agency                                 Ver. 2.00
DEEM-FCID Chronic analysis for SAFLUFENACIL                     (1994-98 data)
Residue file name: C:\Documents and Settings\gkramer\My Documents\Gk\##Saflufenacil-new\Saflufenacil_Chronic.R98
                                                     Adjustment factor #2 used.
Analysis Date 03-18-2011/10:50:20     Residue file dated: 03-18-2011/10:48:46/8
Reference dose (RfD, Chronic) = .046 mg/kg bw/day
===============================================================================
                    Total exposure by population subgroup
-------------------------------------------------------------------------------

                                                    Total Exposure
                                         -----------------------------------
          Population                         mg/kg                 Percent of
           Subgroup                       body wt/day                 Rfd
--------------------------------------   -------------       ---------------
U.S. Population (total)                     0.004219                 9.2%

U.S. Population (spring season)             0.004181                 9.1%
U.S. Population (summer season)             0.004485                 9.8%
U.S. Population (autumn season)             0.004102                 8.9%
U.S. Population (winter season)             0.004103                 8.9%

Northeast region                            0.003901                 8.5%
Midwest region                              0.004257                 9.3%
Southern region                             0.004009                 8.7%
Western region                              0.004797                10.4%

Hispanics                                   0.004879                10.6%
Non-hispanic whites                         0.004094                 8.9%
Non-hispanic blacks                         0.004066                 8.8%
Non-hisp/non-white/non-black                0.005142                11.2%

All infants (< 1 year)                      0.013999                30.4%
Nursing infants                             0.005163                11.2%
Non-nursing infants                         0.017352                37.7%
Children 1-6  yrs                           0.006612                14.4%
Children 7-12 yrs                           0.004135                 9.0%

Females 13-19 (not preg or nursing)         0.003041                 6.6%
Females 20+ (not preg or nursing)           0.004007                 8.7%
Females 13-50 yrs                           0.003987                 8.7%
Females 13+ (preg/not nursing)              0.004031                 8.8%
Females 13+ (nursing)                       0.005626                12.2%

Males 13-19 yrs                             0.003252                 7.1%
Males 20+ yrs                               0.003680                 8.0%
Seniors 55+                                 0.003938                 8.6%

Children 1-2 yrs                            0.007234                15.7%
Children 3-5 yrs                            0.006506                14.1%
Children 6-12 yrs                           0.004370                 9.5%
Youth 13-19 yrs                             0.003159                 6.9%
Adults 20-49 yrs                            0.003811                 8.3%
Adults 50+ yrs                              0.003945                 8.6%
Females 13-49 yrs                           0.003793                 8.2%

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


[Federal Register Volume 82, Number 144 (Friday, July 28, 2017)]
[Notices]
[Page 35200]
[FR Doc No: 2017-15966]

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ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9034-4]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or http://www.epa.gov/nepa.

Weekly receipt of Environmental Impact Statements (EISs) Filed 07/17/
2017 Through 07/21/2017 Pursuant to 40 CFR 1506.9.

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: http://www.epa.gov/compliance/nepa/eisdata.html.

EIS No. 20170134, Final, FHWA, IL, Interstate 290 Eisenhower
Expressway, Contact: Catherine A. Batey<PHONE_NUMBER>, Under MAP-21
Section 1319, FHWA has issued a single FEIS and ROD. Therefore, the 30-
day wait/review period under NEPA does not apply to this action.
EIS No. 20170135, Draft, NPS, WA, Olympic National Park Draft Mountain
Goat Management Plan, Comment Period Ends: 09/26/2017, Contact:
Christina Miller<PHONE_NUMBER>.
EIS No. 20170136, Draft, BIA, WA, Confederated Tribes of the Colville
Reservation Integrated Resource Management Plan 2015, Comment Period
Ends: 09/11/2017, Contact: Anna Schmidt<PHONE_NUMBER>.
EIS No. 20170137, Draft Supplement, Caltrans, CA, I-710 Corridor
Project, Comment Period Ends: 09/22/2017, Contact: Jason Roach 213-897-
0357.
EIS No. 20170138, Final, FERC, VA, Atlantic Coast Pipeline and Supply
Header Project, Review Period Ends: 08/28/2017, Contact: Kevin Bowman
202-502-6287.
EIS No. 20170139, Final, FHWA, IL, US 30 from IL 136 to IL 40 Whiteside
Co., Contact: Catherine A. Batey<PHONE_NUMBER>, Under MAP-21 Section
1319, FHWA has issued a single FEIS and ROD. Therefore, the 30-day
wait/review period under NEPA does not apply to this action.
EIS No. 20170140, Draft, USFS, WY, North Savery Project, Comment Period
Ends: 09/12/2017, Contact: Paula Guenther<PHONE_NUMBER>.
EIS No. 20170141, Draft, AFS, MT, Starry Goat, Comment Period Ends: 09/
11/2017, Contact: Lisa Osborn<PHONE_NUMBER>.
EIS No. 20170142, Adoption, Final, FAA, CA, ADOPTION--Land Acquisition
and Airspace Establishment to Support Large-Scale Marine Air Ground
Task Force Live-Fire and Maneuver Training at Marine Corps Air Ground
Combat Center, Review Period Ends: 09/04/2017, Contact: Paula Miller
202-267-7378. The U.S. Department of Transportation's Federal Aviation
Administration (FAA) has adopted the U.S. Department of Navy's FSEIS
#20160327, filed 12/30/2016 with EPA. FAA was a cooperating agency on
the project and recirculation of the document is not necessary under
Section 1506.3(c) of the CEQ Regulations.

Amended Notices

EIS No. 20170106, Draft, NMFS, OR, Analyze Impacts of NOAA's National
Marine Fisheries Service joining as a signatory to a new U.S. v. Oregon
Management Agreement for the Years 2018-2027, Comment Period Ends: 08/
21/2017, Contact: Jeromy Jording<PHONE_NUMBER>. Revision to the FR
Notice Published 06/23/2017; Extending the Comment Period from 08/07/
2017 to 08/21/2017.

    Dated: July 25, 2017.
Dawn Roberts,
Management Analyst, NEPA Compliance Division, Office of Federal
Activities.
[FR Doc. 2017-15966 Filed 7-27-17; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: April 24, 2006 (Volume 71, Number 78)]
[Notices]
[Page 21008-21009]
[DOCID:fr24ap06-54]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

April 18, 2006.
    Take notice that the Commission received the following electric
rate filings.

    Docket Numbers: ER03-478-011.
    Applicants: PPM Energy, Inc.
    Description: PPM Energy, Inc. submits its motion to terminate
refund liability to reflect PPM's recent corporate disaffiliation with
PacifiCorp.
    Filed Date: April 10, 2006.
    Accession Number: 20060417-0205.
    Comment Date: 5 p.m. Eastern Time on Monday, May 1, 2006.

    Docket Numbers: ER06-20-002.
    Applicants: Louisville Gas & Electric Company.
    Description: LG&E Energy, LLC submits revisions to its proposed
open-access transmission tariff to implement the ``hold harmless
commitment'' under the MISO Transmission Owner Agreement etc., pursuant
to March 17, 2006 order.
    Filed Date: April 11, 2006.
    Accession Number: 20060417-0225.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 2, 2006.

    Docket Numbers: ER06-278-003.
    Applicants: The Nevada Hydro Company, Inc.
    Description: Nevada Hydro Company, Inc. submits a supplemental
response to FERC's February 17, 2006 request for additional
information.
    Filed Date: April 7, 2006.
    Accession Number: 20060417-0190.
    Comment Date: 5 p.m. Eastern Time on Friday, April 28, 2006.

    Docket Numbers: ER06-313-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc.
submits an informational filing regarding suspension of the monthly
financial transmission rights auction for June 2006, et al.
    Filed Date: April 11, 2006.
    Accession Number: 20060413-0142.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 2, 2006.

    Docket Numbers: ER06-561-001.
    Applicants: Southern Company Services, Inc.
    Description: Southern Company Services Inc. agent for Alabama Power
Co. et al. submits its response to FERC's March 8, 2006 deficiency
letter.
    Filed Date: April 7, 2006.
    Accession Number: 20060417-0189.
    Comment Date: 5 p.m. Eastern Time on Friday, April 28, 2006.

    Docket Numbers: ER06-576-001.
    Applicants: Southern Company Services, Inc.
    Description: Southern Company Services Inc. agent for Alabama Power
C.o et al. submits its response to FERC's March 8, 2006 deficiency
letter.
    Filed Date: April 7, 2006.
    Accession Number: 20060417-0191.
    Comment Date: 5 p.m. Eastern Time on Friday, April 28, 2006.

    Docket Numbers: ER06-843-000.
    Applicants: Northeast Utilities Service Company.
    Description: Northeast Utilities Service Company submits a notice
of Cancellation of Service Agreement 8 for Firm Transmission Service
with Unitil Power Corp.
    Filed Date: April 11, 2006.
    Accession Number: 20060417-0185.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 2, 2006.

    Docket Numbers: ER06-847-000; ER05-1235-001.
    Applicants: MidAmerican Energy Company.
    Description: MidAmerican Energy Co submits First Revised Sheet 497
et al. to Electric Tariff, Second Revised Volume 8 to their OATT in
compliance with FERC's December 16, 2005 order.
    Filed Date: April 7, 2006.
    Accession Number: 20060417-0216.
    Comment Date: 5 p.m. Eastern Time on Friday, April 28, 2006.

    Docket Numbers: ER06-848-000.
    Applicants: Appalachian Power Company.
    Description: AEP on behalf of Appalachian Power Co submits a cost-
based formula rate agreement for full requirements electric service
between AEP Service Corp and Black Diamond Power Co et al.
    Filed Date: April 6, 2006.
    Accession Number: 20060417-0183.
    Comment Date: 5 p.m. Eastern Time on Tuesday, April 25, 2006.

    Docket Numbers: ER06-849-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator Inc.
submits the proposed revisions to Attachment L (Credit Policy) of its
Open Access Transmission and Energy Markets Tariff, et al.
    Filed Date: April 7, 2006.
    Accession Number: 20060417-0184.
    Comment Date: 5 p.m. Eastern Time on Friday, April 28, 2006.

    Docket Numbers: ER06-850-000.
    Applicants: Northeast Utilities Service Company.

    Description: Northeast Utilities Service Co. submits a Notice of
Cancellation of NU Companies Service Agreement 16 under ISO New
England's Electric Tariff 3 Attachment E, Schedule 21-NU.
    Filed Date: April 6, 2006.
    Accession Number: 20060417-0176.
    Comment Date: 5 p.m. Eastern Time on Thursday, April 27, 2006.

    Docket Numbers: ER06-851-000.
    Applicants: Northeast Utilities Service Company.
    Description: Northeast Utilities Service Co. submits a Notice of
Cancellation of NU Companies Service Agreement 22 under ISO New
England's Electric Tariff 3 Attachment E, Schedule 21-NU.
    Filed Date: April 6, 2006.
    Accession Number: 20060417-0177.
    Comment Date: 5 p.m. Eastern Time on Thursday, April 27, 2006.

    Docket Numbers: ER06-852-000.
    Applicants: Northeast Utilities Service Company.
    Description: Northeast Utilities Services Co. submits a notice of
cancellation of NU Companies Services Agreement 17 under ISO New
England's Electric Tariff 3 Attachment E, Schedule 21-NU.
    Filed Date: April 6, 2006.
    Accession Number: 20060417-0178.
    Comment Date: 5 p.m. Eastern Time on Thursday, April 27, 2006.

    Docket Numbers: ER06-853-000.
    Applicants: Northeast Utilities Service Company.
    Description: Northeast Utilities Services Co. submits s a notice of
cancellation of NU Companies Service Agreement 28, 29 & 30 under ISO
New England's Electric Tariff 3 Attachment E, Schedule 21-NU.
    Filed Date: April 6, 2006.
    Accession Number: 20060417-0179.
    Comment Date: 5 p.m. Eastern Time on Thursday, April 27, 2006.

    Docket Numbers: ER06-854-000.
    Applicants: Northeast Utilities Service Company.
    Description: Northeast Utilities Service Co. submits a notice of
cancellation of NU Companies Service Agreement 19 under ISO New England
Inc. Electric Tariff No. 3 Attachment E, Schedule 21-NU.
    Filed Date: April 6, 2006.
    Accession Number: 20060417-0180.
    Comment Date: 5 p.m. Eastern Time on Thursday, April 27, 2006.

    Docket Numbers: ER06-855-000.
    Applicants: Northeast Utilities Service Company.
    Description: Northeast Utilities Service Co. submits a notice of
cancellation of NU Companies Service Agreements 24 & 25 under ISO New
England's Electric Tariff No. 3 Attachment E. Schedule 21-NU.
    Filed Date: April 6, 2006.
    Accession Number: 20060417-0181.
    Comment Date: 5 p.m. Eastern Time on Thursday, April 27, 2006.

    Any person desiring to intervene or to protest in any of the above
proceedings 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) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. 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. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov.
 To facilitate electronic service, persons with Internet

access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(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. E6-6053 Filed 4-21-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 235 (Friday, December 10, 2021)]
[Notices]
[Pages 70504-70505]
[FR Doc No: 2021-26730]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0918]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Labeling Requirements
for Prescription Drugs

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 January 10, 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 0910-0572. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, 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.

Labeling Requirements for Prescription Drugs

OMB Control Number 0910-0572--Revision

    This information collection supports FDA regulations governing the
labeling of prescription drugs. The regulations are codified in 21 CFR
part 201, subpart B (21 CFR 201.50 through 201.58) and set forth both
general requirements, as well as specific content and format
requirements. The regulations also provide for requesting a waiver from
any labeling requirement and do not apply to biological products that
are subject to the requirements of section 351 of the Public Health
Service Act.
    We are revising the information collection to include burden
associated with regulations applicable to medical gas labeling found in
Sec.  201.328 (21 CFR 201.328) and established by a final rule in the
Federal Register of November 18, 2016 (81 FR 81685 at 81694). While we
included corresponding changes and adjustments resulting from the final
rule to the information collection approved under OMB control number
0910-0139 as it pertains to good manufacturing practice requirements
and regulations in part 211 (21 CFR part 211), we did not make
corresponding changes and adjustments to this information collection
with regard to burden that may be associated with labeling requirements
found in Sec.  201.328 (81 FR 81685 at 81694).
    To assist respondents with the information collection we continue
to develop and issue guidance documents, available from our searchable
guidance database at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. All Agency guidance documents are issued
consistent with our good guidance practice regulations found in 21 CFR
10.115, which provide for public comment at any time.
    In the Federal Register of September 7, 2021 (86 FR 50134), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    We estimate the burden of the information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
    Activity/21 CFR section        Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per  response
----------------------------------------------------------------------------------------------------------------
Labeling requirements for                  414           1.326             549  3,349...........       1,838,601
 prescription drugs; Sec.
 Sec.   201.56 and 201.57.
Labeling of medical gas                    260           1,663         432,380  0.17 (10                  73,505
 containers; Sec.   201.328.                                                     minutes).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............         432,929  ................       1,912,106
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    New drug product and biological product applicants must: (1) Design
and create prescription drug labeling containing ``Highlights,''
``Contents,'' and ``Full Prescribing Information''; (2) test the
designed labeling (for example, to ensure that the designed labeling
fits into carton-enclosed products); and (3) submit it to FDA for
approval. Based on our experience with the information collection, we
estimate 414 applicants will prepare an average of 549 prescription
drug labels and assume it will require 3,349 hours to design, test, and
submit to FDA as part of a new drug application or a biologics license
application. Similarly, new medical gas containers must meet applicable
requirements found in part 211, as well as specific labeling
requirements in Sec.  201.328. We estimate that 260 respondents will
incur burden for the design, testing, production, and submission of
labeling for new medical gas containers as required under Sec.  201.328
and assume an average of 10 minutes (0.17) is required for these
activities.
    Our estimated burden for the information collection reflects an
overall increase resulting from an increase in submissions for new
product labeling as well as from the revision to include burden
associated with requirements in Sec.  201.328.

    Dated: December 6, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26730 Filed 12-9-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 67 (Monday, April 8, 2019)]
[Notices]
[Page 13947]
[FR Doc No: 2019-06771]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2019-0252]

Information Collection Request to Office of Management and
Budget; OMB Control Number: 1625-0009

AGENCY: Coast Guard, DHS.

ACTION: Sixty-day notice requesting comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an Information Collection Request
(ICR) to the Office of Management and Budget (OMB), Office of
Information and Regulatory Affairs (OIRA), requesting an extension of
its approval for the following collection of information: 1625-0009,
Oil Record Book for Ships; without change. Our ICR describes the
information we seek to collect from the public. Before submitting this
ICR to OIRA, the Coast Guard is inviting comments as described below.

DATES: Comments must reach the Coast Guard on or before June 7, 2019.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2019-0252] to the Coast Guard using the Federal
eRulemaking Portal at https://www.regulations.gov. See the ``Public
participation and request for comments'' portion of the SUPPLEMENTARY
INFORMATION section for further instructions on submitting comments.
    A copy of the ICR is available through the docket on the internet
at https://www.regulations.gov. Additionally, copies are available
from: Commandant (CG-612), Attn: Paperwork Reduction Act Manager, U.S.
Coast Guard, 2703 Martin Luther King Jr. Ave. SE, STOP 7710,
Washington, DC 20593-7710.

FOR FURTHER INFORMATION CONTACT: Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology. Consistent with
the requirements of Executive Order 13771, Reducing Regulation and
Controlling Regulatory Costs, and Executive Order 13777, Enforcing the
Regulatory Reform Agenda, the Coast Guard is also requesting comments
on the extent to which this request for information could be modified
to reduce the burden on respondents. In response to your comments, we
may revise this ICR or decide not to seek an extension of approval for
the Collection. We will consider all comments and material received
during the comment period.
    We encourage you to respond to this request by submitting comments
and related materials. Comments must contain the OMB Control Number of
the ICR and the docket number of this request, [USCG-2019-0252], and
must be received by June 7, 2019.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at https://www.regulations.gov. If your material cannot be
submitted using https://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at https://www.regulations.gov and
can be viewed by following that website's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted
without change to https://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).

Information Collection Request

    Title: Oil Record Book for Ships.
    OMB Control Number: 1625-0009.
    Summary: The Act to Prevent Pollution from Ships (APPS) and the
International Convention for Prevention of Pollution from Ships, 1973,
as modified by the 1978 Protocol relating thereto (MARPOL 73/78),
requires that information about oil cargo or fuel operations be entered
into an Oil Record Book (CG-4602A). The requirement is contained in 33
CFR 151.25.
    Need: This information is used to verify sightings of actual
violations of the APPS to determine the level of compliance with MARPOL
73/78 and as a means of reinforcing the discharge provisions.
    Forms: CG-4602A, Oil Record Book.
    Respondents: Operators of vessels.
    Frequency: On occasion.
    Hour Burden Estimate: The estimated burden has decreased from
28,536 hours to 15,741 hours a year, due to a decrease in the estimated
annual number of responses.

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended.

    Dated: April 2, 2019.
James D. Roppel,
Chief, Office of Information Management, U.S. Coast Guard.
[FR Doc. 2019-06771 Filed 4-5-19; 8:45 am]
 BILLING CODE 9110-04-P