[Federal Register Volume 88, Number 36 (Thursday, February 23, 2023)]
[Notices]
[Pages 11456-11457]
[FR Doc No: 2023-03766]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2023-0002; Internal Agency Docket No. FEMA-B-2308]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: Notice.

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SUMMARY: Comments are requested on proposed flood hazard
determinations, which may include additions or modifications of any
Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area
(SFHA) boundary or zone designation, or regulatory floodway on the
Flood Insurance Rate Maps (FIRMs), and where applicable, in the
supporting Flood Insurance Study (FIS) reports for the communities
listed in the table below. The purpose of this notice is to seek
general information and comment regarding the preliminary FIRM, and
where applicable, the FIS report that the Federal Emergency Management
Agency (FEMA) has provided to the affected communities. The FIRM and
FIS report are the basis of the floodplain management measures that the
community is required either to adopt or to show evidence of having in
effect in order to qualify or remain qualified for participation in the
National Flood Insurance Program (NFIP).

DATES: Comments are to be submitted on or before May 24, 2023.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location https://hazards.fema.gov/femaportal/prelimdownload and the
respective Community Map Repository address listed in the tables below.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
https://msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-2308, to
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance
and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC
20472,<PHONE_NUMBER>, or (email) [email protected].

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
[email protected]; or visit the FEMA Mapping and Insurance
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed below, in accordance with
section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP.
    The communities affected by the flood hazard determinations are
provided in the tables below. Any request for reconsideration of the
revised flood hazard information shown on the Preliminary FIRM and FIS
report that satisfies the data requirements outlined in 44 CFR 67.6(b)
is considered an appeal. Comments unrelated to the flood hazard
determinations also will be considered before the FIRM and FIS report
become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP only may be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at https://www.floodsrp.org/pdfs/srp_overview.pdf.
    The watersheds and/or communities affected are listed in the tables
below. The Preliminary FIRM, and where applicable, FIS report for each
community are available for inspection at both the online location
https://hazards.fema.gov/femaportal/prelimdownload and the respective
Community Map Repository address listed in the tables. For communities
with multiple ongoing Preliminary studies, the studies can be
identified by the unique project number and Preliminary FIRM date
listed in the tables. Additionally, the current effective FIRM and FIS
report for each community are accessible online through the FEMA Map
Service Center at https://msc.fema.gov for comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Michael M. Grimm,
Assistant Administrator for Risk Management, Federal Emergency
Management Agency, Department of Homeland Security.

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                                             Community map repository
               Community                             address
------------------------------------------------------------------------
           Pipestone County, Minnesota and Incorporated Areas
         Project: 17-05-1533S Preliminary Date: August 26, 2022
------------------------------------------------------------------------
City of Edgerton.......................  City Hall, 801 1st Avenue West,
                                          Edgerton, MN 56128.
City of Hatfield.......................  City Hall, 320 C Avenue,
                                          Hatfield, MN 56164.
City of Holland........................  City Hall, 210 Rock Street,
                                          Holland, MN 56139.
City of Ihlen..........................  Ihlen Eden Community Center,
                                          110 Holman Street West, Ihlen,
                                          MN 56164.
City of Jasper.........................  City Hall, 105 East Wall
                                          Street, Jasper, MN 56144.
City of Pipestone......................  Municipal Offices, 119 2nd
                                          Avenue Southwest, Suite #9,
                                          Pipestone, MN 56164.
City of Trosky.........................  City Hall, 220 Broadway Street
                                          South, Trosky, MN 56144.
Unincorporated Areas of Pipestone        Pipestone County Courthouse,
 County.                                  416 Hiawatha Avenue South,
                                          Pipestone, MN 56164.
------------------------------------------------------------------------

              Rock County, Minnesota and Incorporated Areas
         Project: 17-05-1535S Preliminary Date: August 26, 2022
------------------------------------------------------------------------
City of Beaver Creek...................  City Hall, 311 East 1st Avenue,
                                          Beaver Creek, MN 56116.
City of Jasper.........................  City Hall, 105 East Wall
                                          Street, Jasper, MN 56144.
City of Luverne........................  City Hall, 305 East Luverne
                                          Street, Luverne, MN 56156.
City of Magnolia.......................  City Hall, 113 West Luverne
                                          Street, Magnolia, MN 56158.
Unincorporated Areas of Rock County....  Rock County Courthouse, 204
                                          East Brown Street, Luverne, MN
                                          56156.
------------------------------------------------------------------------

[FR Doc. 2023-03766 Filed 2-22-23; 8:45 am]
BILLING CODE 9110-12-P


Notice of Filing of Pesticide Petition PP#8E7324

EPA Registration Division contact: Susan Stanton,<PHONE_NUMBER>

The Interregional Research Project #4 (IR-4)

PP# 8E7324

EPA has received a pesticide petition (PP# 8E7324) from The
Interregional Research Project #4 (IR-4), 500 College Rd. East, Suite
201 W, Princeton, NJ 08540, proposing, pursuant to section 408(d) of the
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to
amend 40 CFR part 180.564 by establishing a tolerance for the combined
residues of Indoxacarb, [(S)-methyl
7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl]am
ino]carbonyl]indeno[1,2e] [1,3,4]oxadiazine-4a(3H)- carboxylate] and its
R-enantiomer [(R)-methyl
7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-(trifluoromethoxy) phenyl]
amino]carbonyl]indeno [1,2-e] [1,3,4] oxadiazine-4a(3H)- carboxylate] in
a 75:25 mixture (DPX-MP062), respectively,  in or on the raw
agricultural commodities Bushberry subgroup 13-07B at 1.5 parts per
million (ppm); Beet, garden, roots at 0.3 ppm; and Beet, garden, tops at
6.0 ppm. EPA has determined that the petition contains data or
information regarding the elements set forth in section 408(d)(2) of the
FFDCA; however, EPA has not fully evaluated the sufficiency of the
submitted data at this time or whether the data supports granting of the
petition.  Additional data may be needed before EPA rules on the
petition.

A. Residue Chemistry

The active ingredient in the end-use formulation, DuPont  Avaunt®
Insecticide, is a 75:25 mixture of two isomers, indoxacarb (DPX-KN128)
and IN-KN127.  Only one of the isomers, indoxacarb (DPX-KN128), has
insecticidal activity.  Since the insecticidal efficacy is based on the
concentration of indoxacarb (DPX-KN128), the application rates have been
normalized on an indoxacarb (DPX-KN128) basis. The proposed tolerance
expression includes both indoxacarb (DPX-KN128) and IN-KN127 and the
residue method does not distinguish between the enantiomers, therefore
residues are reported as the sum of indoxacarb (DPX-KN128) combined with
IN-KN127. Residues of indoxacarb (DPX-KN128) combined with IN-KN127 will
be referred to as "KN128/KN127."

1. Plant metabolism. The metabolism of indoxacarb in plants is
adequately understood to support these tolerances. Plant metabolism
studies in cotton, lettuce, and tomatoes showed no significant
metabolites. The only significant residue was parent compound.

2  Analytical method. The plant residue enforcement method detects and
quantitates indoxacarb in various matrices including sweet corn,
lettuce, tomato, broccoli, apple, grape, cottonseed, tomato, peanut and
soybean commodity samples by HPLC UV. The limit of quantitation in the
method allows monitoring of crops with indoxacarb residues at or above
the levels proposed in these tolerances.

3. Magnitude of residues.

a.	Blueberries Thirteen field trials were conducted on blueberries.
Four foliar applications were made at the maximum use rate of 0.11 lb.
of active ingredient per acre (0.44 lb. of active ingredient maximum
seasonal use rate).  Harvesting was conducted 6 - 8 days after the last
application (PHI- Post Harvest Interval).  The mean field residue value
for blueberries was 0.57 ppm and the maximum at 1.04 ppm.

b.	Garden beets: Five field trials were conducted on garden beets.  Four
applications were made at the maximum use rate of 0.11 lb. of active
ingredient per acre (0.44 lb. of active ingredient maximum seasonal use
rate).  The trials were harvested at 7 days after the final application.
 In addition, one trial was harvested at 3, 10 and 14 days post
application.  The mean field residue value for garden beet roots was
0.164 ppm with a maximum residue level of 0.22 ppm.  The mean field
residue value for garden beet tops was 2.47 ppm with a maximum residue
level of 3.96 ppm.

B. Toxicological Profile

1. Acute toxicity.  Based on EPA criteria, indoxacarb is classified as
follows for Toxicity Categories

	{<P>} 	1. {<E T=’03'>} Acute toxicity{</E>} .  [Based on EPA
criteria, indoxacarb is classified as follows for Toxicity Categories

Guideline	Title	Results	Category

870.1100

870.1200

870.1300

870.2400

870.2500

870.2600	Acute Oral Toxicity

Acute Dermal Toxicity

 Acute Inhalation Toxicity

Primary Eye Irritation

Primary Dermal Irritation

Skin Sensitization	LD50:1730 mg/kg (M  Rat)

LD50: 268 mg/kg/(F  Rat)

LD50: >5000 mg/kg  (Rat)

LC50: >5.5 mg/L (M  Rat)

(70% MUP)

Effects reversed within 72 hours (Rabbit)

No irritation (Rabbit)

Sensitizer (Guinea Pig)	Category II

Category IV

Category IV

Category III

Category IV

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

Formulated products are slightly less acutely toxic than indoxacarb.

In an acute neurotoxicity study, indoxacarb exhibited decreased forelimb
grip strength, decreased foot splay, and some evidence of slightly
reduced motor activity, but only at the highest doses tested. The NOAEL
was 100 mg/kg for males and 12.5 mg/kg for females based on body weight
effects in females   50 mg/kg.

2. Genotoxicty.  Indoxacarb has shown no genotoxic activity in the
following listed in vitro and in vivo tests:

Ames   Negative

In vitro mammalian gene mutation (CHO/HGPRT)   Negative

In vitro unscheduled DNA synthesis   Negative

In vitro chromosomal aberration   Negative

In vivo mouse micronucleus-Negative

3. Reproductive and developmental toxicity.  The results of a series of
studies indicated that there were no reproductive, developmental or
teratogenic hazards associated with the use of indoxacarb. In a 2
generation rat reproduction study, the parental NOAEL was 1.5 mg/kg/day.
The parental NOAEL was based on observations of reduced weight gain and
food consumption for the higher concentration groups of the F0
generation and potential treatment related changes in spleen weights for
the higher groups of the F1 generation. There was no effect on mating or
fertility. The NOAEL for fertility and reproduction was 6.4 mg/kg/day.
The offspring NOAEL was 1.5 mg/kg/day, and was based on the reduced mean
pup weights noted for the F1 litters of the higher concentration groups.
The effects on pup weights occurred only at a maternal effect level and
may have been due to altered growth and nutrition in the dams. In
studies conducted to evaluate developmental toxicity potential,
indoxacarb was neither teratogenic nor uniquely toxic to the conceptus
(i.e., not considered a developmental toxin). Developmental studies
conducted in rats and rabbits demonstrated that the rat was more
susceptible than the rabbit to the maternal and fetal effects of DPX
MP062. Developmental toxicity was observed only in the presence of
maternal toxicity. The NOAEL for maternal and fetal effects in rats was
2 mg/kg/day based on body weight effects and decreased food consumption
at 4 mg/kg/day. The NOAEL for developmental effects in fetuses was >4
mg/kg/day. In rabbits, the maternal and fetal NOAELS were 500 mg/kg/day
based on body weight effects, decreased food consumption in dams and
decreased weight and delayed ossification in fetuses at 1000 mg/kg/day.

In a developmental neurotoxicity study, dams administered 3 mg/kg/day
from gestation day 6 through lactation day 10 had decreased body weight,
weight gain, and food consumption; increased incidences of clinical
signs of toxicity; and test substance-related mortality.  At maternally
toxic doses of 3 mg/kg/day, there was also an increase in offspring
effects including lower body weight.    In addition, beginning on
lactation day 11, offspring  were directly administered the test
substance daily by oral gavage through lactation day 21.  There were no
effects in offspring on learning and memory, sexual maturation, motor
activity, acoustic startle habituation, terminal body weights, brain
weights, selected hematology parameters, neuromorphometric parameters,
or neurohistopathology.  There were no biologically significant effects
on dams or offspring administered dosages of 1.5, 1, or 0.5 mg/kg/day.

4. Subchronic toxicity.  Subchronic (90 day) feeding studies were
conducted with rats, mice, and dogs. In a 90 day feeding study in rats,
the NOAEL was 3.1 and 2.1 mg/kg/day for males and females, respectively.
In male rats, the NOAEL was based on decreased body weight and
nutritional parameters, mild hemolytic anemia and decreased total
protein and globulin concentration. In female rats, the NOAEL was based
on decreased body weight and food efficiency.

In a subchronic neurotoxicity study in rats, there was no evidence of
neurotoxicity at 11.9 and 6.09 mg/kg/day, the highest dose tested for
males and females, respectively. The subchronic NOAEL in dogs (5.0
mg/kg/day, M/F) was based on hemolytic anemia. Erythrocyte values for
most dogs were within a range that would be considered normal for dogs
in a clinical setting. Mice were less sensitive to indoxacarb than the
rats or dogs. NOAELs (23 mg/kg/day, males, 16 mg/kg/day, females) were
based on mortality (males only); increased reticulocytes and Heinz
bodies and decreased body weight, weight gain, food consumption, food
efficiency; and increased clinical signs (leaning to one side and/or
with abnormal gait or mobility) (females only). In a 28 day repeated
dose dermal study, the NOAEL was 50 mg/kg/day based on decreased body
weights, body weight gains, food consumption, and food efficiency in
females, and changes in hematology parameters, the spleen and clinical
signs of toxicity in both sexes in rats.

5. Chronic toxicity. Chronic studies with indoxacarb were conducted on
rats, mice, and dogs to determine oncogenic potential and/or chronic
toxicity of the compound. Effects generally similar to those observed in
the 90 day studies were seen in the chronic studies. Indoxacarb was not
oncogenic in rats or mice. The chronic NOAEL in male rats was 5
mg/kg/day based on body weight and nutritional effects. In females, the
NOAEL of 2.1 mg/kg/day was based on body weight and nutritional changes,
as well as biologically significant hematologic changes at 3.6 mg/kg/day
and above. Hemolytic effects were present only through the 6 month
evaluation and only in females. The regenerative nature of indoxacarb
induced hemolytic anemia was demonstrated by the absence of significant
changes in indicators of circulating erythrocyte mass at later
evaluations. In mice, the chronic NOAEL of 2.6 mg/kg/day for males was
based on deceased body weight and weight gain effects and food
efficiency at 13.8 mg/kg/day and above. The NOAEL for females was 4.0
mg/kg/day based on body weight nutritional effects, neurotoxicity, and
clinical signs at 20 mg/kg/day. In dogs, the chronic NOAEL was about 2.3
and 2.4 mg/kg/day in males and females, respectively based on hemolytic
effects similar to those seen in the subchronic dog study.

6. Animal metabolism. Livestock animal metabolism. Animal metabolism has
been studied in the rat, hen, and cow and is well understood. In
contrast to crops, indoxacarb is extensively metabolized in animals.

Poultry. In poultry, hens were fed at 10 ppm/day for 5 days, 87 88% of
the total administered dose was excreted; parent comprised 51 54% of the
total dose in excreta. Concentrations of residues in eggs were low, 0.3
0.4 of the total dose, as were the concentrations of residues in muscle,
0.2% of the total dose. Parent and metabolite IN JT333 were not detected
in egg whites; only insecticidally inactive metabolites were identified.
Parent and IN JT333 were found in egg yolks; however, their
concentrations were very low 0.01 0.02 ppm. Concentrations of parent and
IN JT333 in muscle were at or below the limit of quantitation, (LOQ)
(0.01 ppm).

Poultry Feeding study.  A poultry feeding study was not conducted for
the initial Section 3 registration because finite concentrations of
residues would not be expected based on the low concentration of
residues in the metabolism study.  However, the Agency has required a
poultry feeding study as a condition of registration for indoxacarb. The
study was submitted on October 31, 2003.  Once the Agency has determined
the components of the tolerance expression, poultry meat, fat,
by-products and egg tolerances will be proposed.

Cattle. For the cow study, the cattle were fed at 10 ppm/day for 5 days;
approximately 20% of the total administered dose was excreted in urine
and 53 60% was excreted in feces in 5 days. Four  tenths to 1.2% of the
total dose in urine was parent indicating extensive metabolism; parent
represented 46 68% of the fecal activity. Thus, most residues were not
absorbed; those residues that were absorbed were extensively
metabolized. Less than 1% of the total administered dose was in milk,
most of which was parent compound. The insecticidally active metabolite
IN JT333 was not found in milk. Residues in muscle represented less than
0.01% of the total administered dose most of which was parent. IN JT333
was not detected in muscle. No other metabolites were seen above 10% of
the dose, thus only parent and IN JT333 were monitored in the cattle
feeding study.

Cattle feeding study.  A cattle feeding study was conducted with
indoxacarb at doses of 7.5 ppm, 22.5 and 75 ppm.  The mean KN128/KN127
concentrations were proportional to the dosing level in whole milk, skim
milk, cream, muscle, fat, liver and kidney. Based on final residue
values for the respective commodities contributing to the cattle diet,
the anticipated dietary burden in dairy cattle is 51.7 ppm and the
anticipated dietary burden in beef cattle is 49.1 ppm. The proposed
grape use will not increase the animal dietary burden. Based on standard
curves constructed from data in the cattle feeding study, KN128/KN127
concentrations at the 51.7-ppm feeding level are 0.123 ppm for whole
milk, 0.033 ppm for skim milk and 1.46 ppm for cream. The KN128/KN127
concentrations at the 49.1 ppm feeding level are 0.046 ppm for muscle,
1.37 ppm for fat, 0.012 ppm for liver and 0.026 ppm for kidney.
Tolerances have been established at 1.5 ppm in fat (cattle, goat, horse,
sheep and hog), 0.05 ppm in meat, 0.03 ppm in meat by products, 0.15 ppm
in milk and 4.0 ppm in milk fat.

7. Metabolite toxicology. In rats, indoxacarb was readily absorbed at
low dose (5 mg/kg), but saturated at the high dose (150 mg/kg).
Indoxacarb was metabolized extensively, based on very low excretion of
parent compound in bile and extensive excretion of metabolized dose in
the urine and feces. Some parent compound remained unabsorbed and was
excreted in the feces. No parent compound was excreted in the urine. The
retention and elimination of the metabolite IN JT333 from fat appeared
to be the overall rate determining process for elimination of
radioactive residues from the body. Metabolites in urine were cleaved
products (containing only one radiolabel), while the major metabolites
in the feces retained both radiolabels. Major metabolic reactions
included hydroxylation of the indanone ring, hydrolysis of the
carboxylmethyl group from the amino nitrogen and the opening of the
oxadiazine ring, which gave rise to cleaved products.  Metabolites were
identified by mass spectral analysis, NMR, UV and/or by comparison to
standards chemically synthesized or produced by microsomal enzymes.

8. Endocrine disruption.  Lifespan, and multigenerational bioassays in
mammals and acute and subchronic studies on aquatic organisms and
wildlife did not reveal endocrine effects. Any endocrine related effects
would have been detected in this definitive array of required tests. The
probability of any such effect due to agricultural uses of indoxacarb is
negligible.

C. Aggregate Exposure

Tolerances for indoxacarb are proposed to support agricultural use on
garden beets and blueberries.

1. Dietary exposure. The chronic RfD of 0.02 mg/kg bw/day is based on a
NOAEL of 2.0 mg/kg bw/day from the subchronic rat feeding study, the
subchronic rat neurotoxicity study, and the chronic/carcinogenicity
study, using an uncertainty factor of 100. The acute RfD for the general
population is 0.12 mg/kg/day, based on the NOAEL of 12.5 mg/kg in the
acute neurotoxicity study and an uncertainty factor of 100.

i. Food. Chronic dietary exposure assessment. Chronic dietary exposure
resulting from the currently approved use of indoxacarb on apples, Crop
group 5 (brassica vegetables), cotton, pears, peppers, sweet corn,
tomatoes, eggplant, alfalfa, head and leaf lettuce, peanuts, potatoes,
soybeans, grapes, leafy Brassica, leafy vegetables crop group 4,
tuberous and corm vegetables crop subgroup 1C, pome fruits crop group 11
(except pear), okra, pea (Southern), mint, Cucurbits (Crop Group 9),
Stone Fruit (Crop Group 12), cranberries, and the proposed uses on
garden beets, and bushberries (Crop SubGroup 13-07B) is well within
acceptable limits for all sectors of the population. The chronic module
of the Dietary Exposure Evaluation Model with Food Commodity Intake
Database (DEEM-FCIDTM, version 2.00, Exponent, Inc.) was used to conduct
the assessment with the chronic reference dose (cRfD) of 0.02mg/kg/ day.
This model incorporates nationwide food consumption data as reported by
respondents in the U.S. Department of Agriculture (USDA) 1994-1996, 1998
Continuing Surveys of Food Intake by Individuals (CSFII).  The analysis
used overall mean field trial values, processing factors and actual and
projected five-year average percent crop treated values. Secondary
residues in milk, meat and poultry products were also included in the
analysis.  The chronic dietary exposure to indoxacarb is 0.000294
mg/kg/day, and utilizes 2% of the cRfD for the overall U.S. population.
The exposure of the most highly exposed subgroup in the population,
children age 1-2 years, is 0.000751 mg/kg/day, which is 4% of the cRfD.
The table below lists the results of this analysis, which indicate large
margins of safety for each population subgroup and very low probability
of effects resulting from chronic exposure to indoxacarb.

 PRIVATE  Subgroup tc  \l 1 "Subgroup" 	Maximum Dietary Exposure
(mg/kg/day)	% cRfD

U.S Population

All infants

Children 1-2

Children 3-5

Children 6-12

Youth 13-19

Adults 20-49

Adults 50+	0.000294

0.000256

0.000751

0.000592

0.000343

0.000257

0.000229

0.000293	2

1

4

3

2

1

1

2

Acute dietary exposure. Acute dietary exposure resulting from the
currently approved use of indoxacarb on apples, Crop group 5 (brassica
vegetables), cotton, pears, peppers, sweet corn, tomatoes, eggplant,
alfalfa, head and leaf lettuce, peanuts, potatoes, soybeans, grapes,
leafy Brassica, leafy vegetables crop group 4, tuberous and corm
vegetables crop subgroup 1C, pome fruits crop group 11 (except pear),
okra, pea (Southern), mint, Cucurbits (Crop Group 9), Stone Fruit (Crop
Group 12), cranberries, and the proposed uses on garden beets, and
bushberries (Crop SubGroup 13-07B) is well within acceptable limits for
all sectors of the population.  The acute module of the Dietary Exposure
Evaluation Model with Food Commodity Intake Database (DEEM-FCIDTM,
version 2.15, Exponent, Inc.) was used to conduct the assessment with
the acute reference dose (aRfD) of 0.12mg/kg/ day. This model
incorporates nationwide food consumption data as reported by respondents
in the U.S. Department of Agriculture (USDA) 1994-1996, 1998 Continuing
Surveys of Food Intake by Individuals (CSFII).  The Tier 3 analysis used
distributions of field trial residue data adjusted for actual and
projected peak percent crop treated. Secondary residues in milk, meat
and poultry products were also included in the analysis.  The results of
this analysis are given in the table below.  The percent of the acute
reference dose (aRfD) for all population subgroups shows that an
adequate margin of safety exists in each case. Thus, the acute dietary
safety of indoxacarb for established and proposed uses clearly meets the
FQPA standard of reasonable certainty of no harm.

Subgroup	99.9th Percentile Of Exposure

	Exposure (mg/kg/day)	% Acute reference dose

(aRfD)

U.S. Population

All infants

Children 1-2

Children 3-5

Children 6-12

Youth 13-19

Adults 20-49

Adults 50+	0.025644

0.067568

0.055866

0.048160

0.022815

0.025837

0.022442

0.026808	21

56

47

40

19

22

19

22

ii. Drinking water. Indoxacarb is highly unlikely to contaminate
groundwater resources due to its immobility in soil, low water
solubility, high soil sorption, and moderate soil half life. Based on
the FIRST Tier 1 surface water and SCI GROW Tier 1 groundwater models
under worst-case conditions the acute estimated environmental
concentrations (EECs) of indoxacarb and its R enantiomer are 15.614
parts per billion (ppb) for surface water and 0.02 ppb for ground water.
The chronic EECs are 1.655 ppb for surface water and 0.02 ppb for ground
water.

When the higher surface water concentrations were included in the acute
and chronic dietary risk assessments, there was little change from the
food-only dietary risk assessments.  For the acute assessment which
included drinking water as a point estimate the predicted exposure at
the 99.9th percentile for the general U.S. population was 0.025710
mg/kg/day which corresponds to 21% of the aRfD; the most sensitive
subpopulation, infants, had an estimated exposure of 0.066107 mg/kg/day,
55% of the aRfD.  For the chronic assessment which included drinking
water the predicted exposure for the general population was 0.000330
mg/kg/day, 2% of the cRfD; the most sensitive subpopulation, children
1-2 years, had an estimated exposure of 0.000804 mg/kg/day, 4% of the
cRfD.  Thus, the acute and chronic dietary exposure of indoxacarb,
including the contribution of drinking water, clearly meets the standard
of reasonable certainty of no harm.

2. Non-dietary exposure. Indoxacarb product registrations for
residential non food uses have been approved. Non-occupational,
non-dietary exposure for indoxacarb has been estimated to be low.

D. Cumulative Effects

EPA's consideration of a common mechanism of toxicity is not necessary
at this time because there is no indication that toxic effects of
indoxacarb would be cumulative with those of any other chemical
compounds. Indoxacarb has a novel mode of action compared to currently
registered active ingredients.

E. Safety Determination

1. U.S. population. Based on the completeness and reliability of the
toxicity data and the conservative exposure assessments, there is a
reasonable certainty that no harm will result from the aggregate
exposure of residues of indoxacarb including all anticipated dietary
exposure and all other non occupational exposures.

2. Infants and children. Based on the completeness and reliability of
the toxicity data, the lack of toxicological endpoints of special
concern, the lack of any indication that children are more sensitive
than adults to indoxacarb, and the conservative exposure assessment,
there is a reasonable certainty that no harm will result to infants and
children from the aggregate exposure of residues of indoxacarb,
including all anticipated dietary exposure and all other
non-occupational exposures. Accordingly, there is no need to apply an
additional safety factor for infants and children.

F. International Tolerances

To date, numerous tolerances exist for indoxacarb residues in various
food and feed crops and foods of animal origin in at least 25 countries.


[Federal Register Volume 77, Number 233 (Tuesday, December 4, 2012)]
[Rules and Regulations]
[Pages 71695-71697]
[FR Doc No: 2012-29279]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 173

[Docket No. FDA-2011-F-0853]

Secondary Direct Food Additives Permitted in Food for Human
Consumption; Sodium Dodecylbenzenesulfonate

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the food
additive regulations to provide for the safe use of sodium
dodecylbenzenesulfonate (CAS No. 25155-30-0) as an antimicrobial agent
for use in wash water for fruits and vegetables without the requirement
of a potable water rinse. This action is in response to a petition
filed by Ecolab, Inc.

DATES: This rule is effective December 4, 2012. Submit either
electronic or written objections and requests for a hearing by January
3, 2013. See section VII of this document for information on the filing
of objections.

ADDRESSES: You may submit either electronic or written objections and
requests for a hearing, identified by Docket No. FDA-2011-F-0853, by
any of the following methods:

Electronic Submissions

    Submit electronic objections in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written objections in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (for paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2011-F-0853 for this rulemaking. All objections
received will be posted without change to http://www.regulations.gov,
including any personal information provided. For detailed instructions
on submitting objections, see the ``Objections'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
objections 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.

FOR FURTHER INFORMATION CONTACT: Molly Harry, Center for Food Safety
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In a notice published in the Federal Register of February 2, 2012
(77 FR 5201), FDA announced that a food additive petition (FAP 2A4785)
had been filed by Ecolab, Inc., 370 North Wabasha St., St. Paul, MN
55102-1390. The petition proposed to amend the food additive
regulations in part 173, ``Secondary Direct Food Additives Permitted in
Food for Human Consumption'' (21 CFR part 173), to provide for the safe
use of sodium dodecylbenzenesulfonate (SDBS) as an antimicrobial agent
used as a component of an antimicrobial formulation added to wash water
for fruits and vegetables (e.g., whole fruits and vegetables as well as
fruits, vegetables, and herbs that have been chopped, sliced, cut, or
peeled) to reduce microorganisms in wash water

and on the surfaces of treated fruits and vegetables. Fruits and
vegetables treated by the additive do not require a potable water
rinse. The petition requested that the additive be considered for use
only in certain food service facilities. The additive may be used at a
level not to exceed 111 milligrams per kilogram of the wash water.
    The use of SDBS is currently approved in washing or to assist in
the peeling of fruits and vegetables under Sec.  173.315 provided its
use is followed by a potable water rinse. In addition, FDA food
additive regulations permit the use of SDBS as an indirect food
additive for use as a component of single and repeated use food contact
substances (21 CFR 177.1010, 177.1200, 177.1630, 177.2600, and
177.2800), in sanitizing solutions (21 CFR 178.1010), and in the
production of animal glue (21 CFR 178.3120).
    The definition of ``pesticide chemical'' under section
201(q)(1)(B)(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 321(q)(1)(B)(i)), excludes an antimicrobial added to
water that comes into contact with food, in the preparing, packing, or
holding of the food for commercial purposes. This exclusion applies
whether the water is to contact raw agricultural commodities or
processed food. Consequently, such an antimicrobial is a ``food
additive'' under section 201(s) of the FD&C Act and subject to the
requirements in section 409 of the FD&C Act (21 U.S.C. 348). The
petitioned use of SDBS as an antimicrobial agent in processing water is
for a food additive use in certain food service facilities. Although
the petitioned use of SDBS is regulated under section 409 of the FD&C
Act as a food additive, this intended use of SDBS may nevertheless be
subject to regulation as a pesticide under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA). Therefore, manufacturers
intending to use this food additive for this intended use should
contact the Environmental Protection Agency to determine whether this
use requires a pesticide registration under FIFRA.

II. Evaluation of Safety

    Under the general safety standard in section 409 of the FD&C Act, a
food additive cannot be approved for a particular use unless a fair
evaluation of the data available to FDA establishes that the additive
is safe for that use. FDA's food additive regulations (21 CFR 170.3(i))
define ``safe'' as ``a reasonable certainty in the minds of competent
scientists that the substance is not harmful under the intended
conditions of use.''
    To establish with reasonable certainty that a food additive is not
harmful under its intended conditions of use, FDA considers the
projected human dietary intake of the additive, the additive's
toxicological data, and other relevant information (such as published
literature) available to FDA. As part of FDA's safety evaluation, FDA
reviewed data from published studies in animals on the safety of SDBS,
including a 2-year carcinogenicity study in rats and a multigeneration
reproductive study with rats. Based on the results from these studies
and FDA's estimated dietary intake to SDBS from current and the
proposed food uses, FDA concludes that there is a reasonable certainty
of no harm and the petitioned use of SDBS is safe within the meaning of
section 409 of the FD&C Act.

III. Conclusion

    FDA reviewed data in the petition and other available relevant
material to evaluate the safety of SDBS as an antimicrobial agent for
use in wash water for fruits and vegetables without the requirement of
a potable water rinse. Based on this information, FDA concludes that
the proposed use of the additive is safe and the additive will achieve
its intended technical effect as an antimicrobial agent under the
proposed conditions of use. Therefore, the regulations in part 173
should be amended as set forth in this document.

IV. Public Disclosure

    In accordance with Sec.  171.1(h) (21 CFR 171.1(h)), the petition
and the documents that FDA considered and relied upon in reaching its
decision to approve the petition will be made available for inspection
at the Center for Food Safety and Applied Nutrition by appointment with
the information contact person (see FOR FURTHER INFORMATION CONTACT).
As provided in Sec.  171.1(h), FDA will delete from the documents any
materials that are not available for public disclosure before making
the documents available for inspection.

V. Environmental Impact

    FDA has carefully considered the potential environmental effects of
this action. FDA has concluded that the action will not have a
significant impact on the human environment, and that an environmental
impact statement is not required. FDA's finding of no significant
impact and the evidence supporting that finding, contained in an
environmental assessment, may be seen in the Division of Dockets
Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through
Friday.

VI. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.

VII. Objections

    Any person who will be adversely affected by this regulation may
file with the Division of Dockets Management (see ADDRESSES) either
electronic or written objections. Each objection shall be separately
numbered, and each numbered objection shall specify with particularity
the provisions of the regulation to which objection is made and the
grounds for the objection. Each numbered objection on which a hearing
is requested shall specifically so state. Failure to request a hearing
for any particular objection shall constitute a waiver of the right to
a hearing on that objection. Each numbered objection for which a
hearing is requested shall include a detailed description and analysis
of the specific factual information intended to be presented in support
of the objection in the event that a hearing is held. Failure to
include such a description and analysis for any particular objection
shall constitute a waiver of the right to a hearing on the objection.
It is only necessary to send only one set of documents. Identify
documents with the docket number found in brackets in the heading of
this document. Any objections received in response to the regulation
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.

VIII. Section 301(ll) of the FD&C Act

    FDA's review of this petition was limited to section 409 of the
FD&C Act. This final rule is not a statement regarding compliance with
other sections of the FD&C Act. For example, the Food and Drug
Administration Amendments Act of 2007, which was signed into law on
September 27, 2007, amended the FD&C Act to, among other things, add
section 301(ll) (21 U.S.C. 331(ll)). Section 301(ll) of the FD&C Act
prohibits the introduction or delivery for introduction into interstate
commerce of any food that contains a drug approved under section 505 of
the FD&C Act (21 U.S.C. 355), a biological product licensed under
section 351 of the Public Health Service Act (42 U.S.C. 262), or a drug
or biological product for which substantial clinical investigations
have been instituted and their existence has been made public, unless
one of the

exemptions in section 301(ll)(1) to (ll)(4) applies. In our review of
this petition, FDA did not consider whether section 301(ll) or any of
its exemptions apply to food containing this additive. Accordingly,
this final rule should not be construed to be a statement that a food
containing this additive, if introduced or delivered for introduction
into interstate commerce, would not violate section 301(ll) of the FD&C
Act. Furthermore, this language is included in all food additive final
rules and therefore should not be construed to be a statement of the
likelihood that section 301(ll) of the FD&C Act applies.

List of Subjects in 21 CFR Part 173

    Food additives.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Director, Center for Food Safety and Applied
Nutrition, 21 CFR part 173 is amended as follows:

PART 173--SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR
HUMAN CONSUMPTION

0
1. The authority citation for 21 CFR part 173 continues to read as
follows:

    Authority: 21 U.S.C. 321, 342, 348.

0
2. Section 173.405 is added to subpart D to read as follows:

Sec.  173.405  Sodium dodecylbenzenesulfonate.

    Sodium dodecylbenzenesulfonate (CAS No. 25155-30-0) may be safely
used in accordance with the following prescribed conditions:
    (a) The additive is an antimicrobial agent used in wash water for
fruits and vegetables. The additive may be used at a level not to
exceed 111 milligrams per kilogram in the wash water. Fruits and
vegetables treated by the additive do not require a potable water
rinse.
    (b) The additive is limited to use in commissaries, cafeterias,
restaurants, retail food establishments, nonprofit food establishments,
and other food service operations in which food is prepared for or
served directly to the consumer.
    (c) To assure safe use of the additive, the label or labeling of
the additive container shall bear, in addition to the other information
required by the Federal Food, Drug, and Cosmetic Act, adequate
directions to assure use in compliance with the provisions of this
section.

    Dated: November 28, 2012.
Susan M. Bernard,
Director, Office of Regulations, Policy and Social Sciences, Center for
Food Safety and Applied Nutrition.
[FR Doc. 2012-29279 Filed 12-3-12; 8:45 am]
BILLING CODE 4160-01-P