EPA Registration Division contact: Barbara Madden, 703 305 6463 The Interregional Research Project # 4 ( IR 4)

PP# 5E6991 EPA has received a pesticide petition ( PP# 5E6991) from The Interregional Research Project # 4 ( IR 4), 681 U. S. Highway # 1 South, North Brunswick, NJ 08902 3390, 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 residues of the combined residues of Indoxacarb, [( S) methyl 7 chloro 2,5 dihydro 2[[( methoxycarbonyl)[ 4( trifluoromethoxy) phenyl] amino] 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: Vegetable, cucurbit, group 9 at 0.5 parts per million ( ppm); Fruit, stone, group 12 at 1.0 ppm; and Cranberry at 1.0 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. Cucurbits Crop Group 9: The average field residue value for all cucurbits was 0.049 ppm and the maximum was 0.393 ppm. i. Ten field trials were conducted on cucumber. 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). Harvesting was conducted 3 days after the last application ( PHI Post Harvest Interval). The median field residue value for cucumbers was 0.023 ppm and the maximum at 0.069 ppm. ii. Twelve field trials were conducted on cantaloupe ( muskmelon). 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). For the twelve trials, a median 0.103 ppm residue level and a 0.393 ppm maximum residue were recorded. The trials were harvested at 3, 4, and 5 days after the final application. iii. Eleven field trials were conducted on summer squash. 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). For the eleven trials, harvesting was conducted giving a median 0.027 ppm residue level and a 0.120 ppm maximum residue. The trials were harvested at 2, 3 and 4 days after the final application. b. Stone Fruit Crop Group 12: The average field residue value for all stone fruits was 0.164 ppm and the maximum was 0.640 ppm. i. Sixteen field trials were conducted on cherry. 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 12, 13, 14, and 15 days after the final application for sixteen ( 16) field trials. The median field residue value for cherry was 0.0.231 ppm with a maximum residue level of 0.640 ppm. ii. Fifteen field trials were conducted on peach. 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 13, 14, and 15 days after the final application for fifteen ( 15) field trials. The median field residue value for peach was 0.183 ppm with a maximun residue level of 0.590ppm. iii. Twelve field trials were conducted on plum. 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). Twelve field trials were harvested 13, 14, 15 and 16 days after the final application. The median field residue value for peach was 0.045 ppm with a maximum residue value of 0.190 ppm. c. Cranberries Six trials were conducted to determine residues for cranberries. 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 28, 29, and 30 days following the final application. Average residues for the six trials were 0.22 ppm with a maximum residue of 0.69 ppm. B. Toxicological Profile 1. Acute toxicity. 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 ( Male Rat) LD50: 268 mg/ kg/( Female Rat)

LD50: > 5000 mg/ kg ( Rat)

LC50: > 5.5 mg/ L ( Male 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. 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 leafy greens, except spinach, subgroup 4A, spinach, leaf petioles subgroup 4B, fruit, pome, except pear, group 11, vegetables, tuberous and corm, subgroup 1C, okra, pea ( southern), and mint. Tolerances for indoxacarb are pending to support agricultural use on grapes and leafy brassica.

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. The acute RfD for females 13 50 years of age is 0.02 mg/ kg/ day, based on the NOAEL of 2 mg/ kg/ day observed in the developmental rat toxicity study and using 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, and the proposed uses on grapes, leafy Brassica, leafy greens crop subgroup 4A ( except spinach), spinach, leaf petioles crop subgroup 4B, 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), and Cranberries are well within acceptable limits for all sectors of the population. The Chronic Module of the Dietary Exposure Evaluation Model ( DEEM, Exponent, Inc., formerly Novigen Sciences, Inc., Version 7.87) was used to conduct the assessment with the reference dose ( RfD) of 0.02mg/ kg/ day. The analysis used overall mean field trial values, processing factors and projected peak 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 0.000191 mg/ kg/ day, and utilizes 1% of the RfD for the overall U. S. population. The exposure of the most highly exposed subgroup in the population, children age 1 2 years, is 0.000362 mg/ kg/ day, and utilizes 2% of the RfD. 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.

SubgroupSubgroup 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+ 0.000191 0.000133 0.000362 0.000329 0.000199 0.000176 0.000167 0.000192 1 1 2 2 1 1 1 1 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, and the proposed uses on grapes, leafy Brassica, leafy greens crop subgroup 4A ( except spinach), spinach, leaf petioles crop subgroup 4B, 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), and Cranberries are well within acceptable limits for all sectors of the population. The Dietary Exposure Evaluation Model ( DEEM, Exponent, Inc., formerly Novigen Sciences, Inc., Version 7.87) was used to conduct the assessment. Margins of exposure ( MOE) were calculated based on a NOAEL of 12 mg/ kg/ day for children and the general population ( Pesticide Fact Sheet for Indoxacarb). An endpoint of concern attributable to a single dose was not identified for women of childbearing age; therefore an acute RfD was not established for this population. The Tier 3 analysis used distributions of field trial residue data adjusted for 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 population adjusted dose ( a PAD) 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 the follow on use clearly meets the FQPA standard of reasonable certainty of no harm and presents acceptable acute dietary risk.

Subgroup 99.9th Percentile Of Exposure Exposure ( mg/ kg/ day) % Acute population adjusted dose ( aPAD) U. S. Population All infants Children 1 2 Children 3 5 Children 6 12 Youth 13 19 Adults 20 49 Adults 50+ 0.020408 0.018959 0.027676 0.036348 0.018096 0.022845 0.019081 0.019863 17 16 23 30 15 19 16 17 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 PRZM/ EXAMS and SCI GROW models the estimated environmental concentrations ( EECs) of indoxacarb and its R enantiomer for acute exposures are estimated to be 6.84 parts per billion ( ppb) for surface water and 0.0025 ppb for ground water. The EECs for chronic exposures are estimated to be 0.316 ppb for surface water and 0.0025 ppb for ground water. Drinking water levels of comparison ( DWLOCs), theoretical upper allowable limits on the pesticide's concentration in drinking water, were calculated to be much higher than the EECs. The chronic DWLOCs ranged from 198 to 697 ppb. The acute DWLOCs ranged from 440 to 3890 ppb. Thus, exposure via drinking water is acceptable.

2. Non dietary exposure. Indoxacarb product registrations for residential non food uses have been approved. Non occupational, non dietary exposure for DPX MP062 has been estimated to be extremely small. Therefore, the potential for non dietary exposure is insignificant. 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. Oxadiazine chemistry is new, and indoxacarb has a novel mode of action compared to currently registered active ingredients.

E. Safety Determination 1. U. S. population. Dietary and occupational exposure will be the major routes of exposure to the U. S. population, and ample margins of safety have been demonstrated for both situations. The chronic dietary exposure to indoxacarb is 0.000191 mg/ kg/ day, which utilizes 1% of the RfD for the overall U. S. population, using mean field trial values, processing factors and projected peak percent crop treated values. The percent of the acute population adjusted dose ( 17% aPAD) for the overall U. S. population shows that an adequate margin of safety exists. Using only PHED data levels A and B ( those with a high level of confidence), MOEs for occupational exposure are 650 for mixer/ loaders and 1351 for air blast applicators ( worst case). 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. Chronic dietary exposure of the most highly exposed subgroup in the population, children age 1 2 years, is 0.000362 mg/ kg/ day or 2% of the RfD. For all infants, the exposure accounts for 1% of the RfD. For acute exposure at the 99.9th percentile ( based on a Tier 3 assessment) the exposure was 0.036348 mg/ kg/ day ( 30% aPAD) for children 3 5 and 0.018959 mg/ kg/ day ( 16% aPAD) for all infants. Residential uses of indoxacarb have been approved and exposure is calculated to be extremely minimal. The estimated levels of indoxacarb in drinking water are well below the below the DWLOC. 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 83, Number 128 (Tuesday, July 3, 2018)]
[Rules and Regulations]
[Pages 31062-31064]
[FR Doc No: 2018-14244]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2018-0514]
RIN 1625-AA00

Safety Zone; Gulf Intracoastal Waterway, Lafitte, LA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
certain navigable waters of the Gulf Intracoastal Waterway in Lafitte,
LA. The safety zone is necessary to protect persons, vessels, and the
marine environment from potential hazards created by the Jean Lafitte
Pirogue Race. Entry of persons or vessels into this zone is prohibited
unless authorized by the Captain of the Port Sector New Orleans or a
designated representative.

DATES: This rule is effective from 11:30 a.m. through 4 p.m. on July
21, 2018.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2018-0514 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Commander Howard Vacco, Sector New Orleans,
U.S. Coast Guard; telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port Sector New Orleans
DHS Department of Homeland Security
FR Federal Register
MM Mile marker
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(3)(B), the Coast Guard finds that
good cause exists for not publishing a notice of proposed rulemaking
(NPRM) with respect to this rule because it is impracticable. It is
impracticable to publish an NPRM because we must establish this safety
zone by July 21, 2018 and lack sufficient time to provide a reasonable
comment period and then consider those comments before issuing the
rule.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule is contrary to the public interest because immediate action
is needed to respond to the potential safety hazards associated with
this boat race.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. The Captain of the Port Sector New Orleans (COTP) has determined
that potential hazards associated with a boat race on July 21, 2018,
will be a safety concern for anyone within a one-mile section of the
Gulf Intracoastal Waterway. Possible hazards include risks of injury or
death from near or actual contact among participant vessels and
mariners traversing through the safety zone. This rule is necessary to
protect persons, vessels, and the marine environment during the race.

IV. Discussion of the Rule

    This rule establishes a temporary safety zone from 11:30 a.m.
through 4 p.m. on July 21, 2018. This zone will encompass all navigable
waters of the Gulf Intracoastal Waterway between mile markers (MMs) 12
and 13 west of the Harvey Locks in Lafitte, LA. The duration of the
zone is intended to protect persons, vessels, and the marine
environment during the race and will include breaks and opportunity for
vessels to transit through the regulated area.
    No vessel or person will be permitted to enter the safety zone
without obtaining permission from the COTP or a designated
representative. A designated representative is a commissioned, warrant,
or petty officer of the U.S. Coast Guard assigned to units under the
operational control of USCG Sector New Orleans. Vessels requiring entry
into this safety zone must request permission from the COTP or a
designated representative. They may be contacted on VHF-FM Channel 16
or 67 or by telephone at<PHONE_NUMBER>.
    A designated representative may be a Patrol Commander (PATCOM). The
PATCOM may be aboard either a Coast Guard or Coast Guard Auxiliary
vessel. The PATCOM may be contacted on Channel 16 VHF-FM (156.8 MHz) by
the call sign ``PATCOM''. The ``official patrol vessels'' consist of
any Coast Guard, state, or local law enforcement and sponsor provided
vessels assigned or approved by the COTP or a designated representative
to patrol the zone. All persons and vessels not registered with the
sponsor as participants or official patrol vessels are considered
spectators.
    Spectator vessels desiring to transit the zone may do so only with
prior approval of the COTP or a designated representative and when so
directed by that officer must be operated at a minimum safe navigation
speed in a

manner that will not endanger any other vessels. No spectator vessel
shall anchor, block, loiter, or impede the through transit of official
patrol vessels in the zone during the effective date and times, unless
cleared for entry by or through the COTP or a designated
representative. Any spectator vessel may anchor outside the zone, but
may not anchor in, block, or loiter in a navigable channel. Spectator
vessels may be moored to a waterfront facility within the zone in such
a way that they shall not interfere with the progress of the event.
Such mooring must be complete at least 30 minutes prior to the
establishment of the zone and remain moored through the duration of the
event.
    The COTP or a designated representative may forbid and control the
movement of all vessels in the zone. When hailed or signaled by an
official patrol vessel, a vessel shall come to an immediate stop and
comply with the directions given. Failure to do so may result in
expulsion from the zone, citation for failure to comply, or both.
    The COTP or a designated representative may terminate the operation
of any vessel at any time it is deemed necessary for the protection of
life or property. The COTP or a designated representative will
terminate enforcement of the safety zone at the conclusion of the
event.
    The COTP or a designated representative will inform the public of
the enforcement periods of this safety zone through Broadcast Notices
to Mariners (BNMs), Local Notices to Mariners (LNMs), and/or Marine
Safety Information Bulletins (MSIBs) as appropriate.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size and
duration of the temporary safety zone. This temporary safety zone
covers a one-mile section of the Gulf Intracoastal Waterway for only
four and a half hours on one day. Moreover, the Coast Guard will issue
a BNMs via VHF-FM marine channel 16 about the zone, breaks may provide
an opportunity for vessels to transit through the safety zone, and the
rule allows vessels to seek permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
temporary safety zone may be small entities, for the reasons stated in
section V.A above, this rule will not have a significant economic
impact on any vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Commandant Instruction M16475.1D, which guide the
Coast Guard in complying with the National Environmental Policy Act of
1969 (42 U.S.C. 4321-4370f), and have determined that this action is
one of a category of actions that do not individually or cumulatively
have a significant effect on the human environment. This rule involves
a safety

zone lasting only four and a half hours on one day that will prohibit
entry within a one-mile stretch of the Gulf Intracoastal Waterway. It
is categorically excluded from further review under paragraph L60(a) of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A
Record of Environmental Consideration supporting this determination is
available in the docket where indicated under ADDRESSES.

G. Protest Activities

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

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-
1, 6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T08-0514 to read as follows:

Sec.  165.T08-0514   Safety Zone; Gulf Intracoastal Waterway, Lafitte,
LA.

    (a) Location. The following area is a safety zone: All navigable
waters of the Gulf Intracoastal Waterway, from mile markers (MMs) 12 to
13 west of the Harvey Locks, Lafitte, LA.
    (b) Effective period. This section is effective from 11:30 a.m.
through 4 p.m. on July 21, 2018.
    (c) Enforcement periods. This section will be enforced during the
effective period. However, breaks in the racing may occur during the
enforcement periods, which will allow for vessels to pass through the
safety zone. The Captain of the Port Sector New Orleans (COTP) or a
designated representative will provide notice of breaks as appropriate
under (e) Informational broadcasts.
    (d) Regulations. (1) In accordance with the general regulations in
Sec.  165.23, entry into this zone is prohibited unless authorized by
the COTP or designated representative. A designated representative is a
commissioned, warrant, or petty officer of the U.S. Coast Guard
assigned to units under the operational control of USCG Sector New
Orleans. They may be contacted on VHF-FM Channel 16 or 67 or by
telephone at<PHONE_NUMBER>. A designated representative may be a
Patrol Commander (PATCOM). The PATCOM may be aboard either a Coast
Guard or Coast Guard Auxiliary vessel. The Patrol Commander may be
contacted on Channel 16 VHF-FM (156.8 MHz) by the call sign ``PATCOM''.
    (2) All persons and vessels not registered with the sponsor as
participants or official patrol vessels are considered spectators. The
``official patrol vessels'' consist of any Coast Guard, state, or local
law enforcement and sponsor provided vessels assigned or approved by
the COTP or a designated representative to patrol the regulated area.
    (3) Spectator vessels desiring to transit the regulated area may do
so only with prior approval of the Patrol Commander and when so
directed by that officer will be operated at a minimum safe navigation
speed in a manner which will not endanger participants in the regulated
area or any other vessels.
    (4) No spectator vessel shall anchor, block, loiter, or impede the
through transit of participants or official patrol vessels in the
regulated area during the effective dates and times, unless cleared for
entry by or through an official patrol vessel.
    (5) Any spectator vessel may anchor outside the regulated area, but
may not anchor in, block, or loiter in a navigable channel. Spectator
vessels may be moored to a waterfront facility within the regulated
area in such a way that they shall not interfere with the progress of
the event. Such mooring must be complete at least 30 minutes prior to
the establishment of the regulated area and remain moored through the
duration of the event.
    (6) The COTP or a designated representative may forbid and control
the movement of all vessels in the regulated area. When hailed or
signaled by an official patrol vessel, a vessel shall come to an
immediate stop and comply with the directions given. Failure to do so
may result in expulsion from the area, citation for failure to comply,
or both.
    (7) The COTP or a designated representative may terminate the event
or the operation of any vessel at any time it is deemed necessary for
the protection of life or property.
    (8) The COTP or a designated representative will terminate
enforcement of the special local regulations at the conclusion of the
event.
    (e) Informational broadcasts. The COTP or a designated
representative will inform the public of the effective period for the
safety zone as well as any changes in the dates and times of
enforcement through Local Notice to Mariners (LNMs), Broadcast Notices
to Mariners (BNMs), and/or Marine Safety Information Bulletins (MSIBs)
as appropriate.

    Dated: June 27, 2018.
K.M. Luttrell,
Captain, U.S. Coast Guard, Captain of the Port Sector New Orleans.
[FR Doc. 2018-14244 Filed 7-2-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 84, Number 103 (Wednesday, May 29, 2019)]
[Rules and Regulations]
[Pages 24722-24726]
[FR Doc No: 2019-11094]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0275; FRL-9993-48]

Clofentezine; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of
clofentezine in or on guava. The Interregional Research Project Number
4 (IR-4) requested this tolerance under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective May 29, 2019. Objections and
requests for hearings must be received on or before July 29, 2019, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2018-0275, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP
test guidelines referenced in this document electronically, please go
to https://www.epa.gov/aboutepa/about-office-chemical-safety-and-pollution-prevention-ocspp and select ``Test Methods and Guidelines.''

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an

objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2018-0275 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
July 29, 2019. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2018-0275, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of July 24, 2018 (83 FR 34968) (FRL-9980-
31), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
8E8660) by The Interregional Research Project Number 4 (IR-4), Rutgers,
The State University of New Jersey, 500 College Road East, Suite 201W,
Princeton, NJ 08540. The petition requested that 40 CFR 180.446 be
amended by establishing tolerances for residues of the insecticide
clofentezine, 3,6-bis(2-chlorphenyl)-1,2,4,5-tetrazine, in or on guava
at 1 part per million (ppm). That document referenced a summary of the
petition prepared by Makhteshim Agan of North America (ADAMA), the
registrant, which is available in the docket, http://www.regulations.gov. One comment was received on the notice of filing.
EPA's response to the comment is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA is
establishing a tolerance level for residues in or on guava at 3 ppm
rather than 1 ppm as requested. The reason for this change is explained
in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for clofentezine including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with clofentezine follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The primary target organ is the liver with secondary effects
on the thyroid. There is no concern for increased quantitative or
qualitative susceptibility of the young following in utero (rats and
rabbits) and pre-and post-natal exposure (rats) to clofentezine.
Clofentezine has been classified as a possible human carcinogen based
on male rat thyroid follicular cell adenoma and/or carcinoma combined
tumor rates. The Q1* value for clofentezine using the \3/4\
interspecies scaling factor is 3.76 x 10-\2\ (mg/kg/
day)-\1\. Clofentezine is not considered a mutagen.
    Further detail on the toxicological profile for clofentezine is
discussed in Unit II.A. of the final rule published in the Federal
Register of June 14, 2016 (81 FR 38605) (FRL-9942-23).
    Specific information on the studies received and the nature of the
adverse effects caused by clofentezine as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Clofentezine. Human-Health Risk
Assessment to Support a Section 3 New Use on Guava'' at page 14 in
docket ID number EPA-HQ-OPP-2018-0275.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://

www.epa.gov/pesticide-science-and-assessing-pesticide-risks.
    A summary of the toxicological endpoints for clofentezine used for
human risk assessment is discussed in Unit II.B of the final rule
published in the Federal Register of June 14, 2016 (81 FR 38606) (FRL-
9942-23).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to clofentezine, EPA considered exposure under the petitioned-
for tolerances as well as all existing clofentezine tolerances in 40
CFR 180.446. EPA assessed dietary exposures from clofentezine in food
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for clofentezine; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the United States
Department of Agriculture's (USDA's) 2003-2008 National Health and
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As
to residue levels in food, EPA used anticipated residues (average
residues from available field trial data) for all registered and
proposed commodities as well as empirical and updated 2018 default
processing factors. Where data were available, the Agency used percent
crop treated estimates; otherwise, EPA assumed 100 percent crop
treated.
    iii. Cancer. Based on the data cited in Unit III.A., EPA has
concluded that clofentezine should be classified as ``Likely to be
Carcinogenic to Humans'' and a linear approach has been used to
quantify cancer risk. Cancer risk was quantified using the same
estimates as discussed in Unit III.C.1.ii., Chronic exposure.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, and the exposure estimate does not
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    The Agency estimated the average PCT for existing uses as follows:
Almonds: 5%; apples: 2.5%; apricots: 2.5%; cherries: 5%; grapes: 1%;
nectarines: 5%; peaches: 5%; pears: 5%; and walnuts: 5%.
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6-7
years. EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available public and private market survey data for that use, averaging
across all observations, and rounding to the nearest 5%, except for
those situations in which the average PCT is less than one. In those
cases, 1% is used as the average PCT and 2.5% is used as the maximum
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The
maximum PCT figure is the highest observed maximum value reported
within the recent 6 years of available public and private market survey
data for the existing use and rounded up to the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which clofentezine may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for clofentezine in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of clofentezine. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the First Index Reservoir Screening Tool (FIRST) and
Pesticide Root Zone Model Ground Water (PRZM-GW) models, the estimated
drinking water concentrations (EDWCs) of clofentezine acute exposures
are estimated to be 7.59 parts per billion (ppb) for surface water and
less than 0.05 ppb for ground water. For chronic exposures for non-
cancer assessments, the EDWCs are estimated to be 0.062 ppb for surface
water and less than 0.05 ppb for ground water. For chronic exposures
for cancer assessments, the EDWC is estimated to be 0.025 ppb for
surface.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration value of 0.062 ppb was used to
assess the contribution to drinking water. For cancer dietary risk
assessment, the water concentration value of 0.025 ppb was used to
assess the contribution to drinking water.

    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Clofentezine is not
registered for any specific use patterns that would result in
residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found clofentezine to share a common mechanism of
toxicity with any other substances, and clofentezine does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
clofentezine does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There is no concern for
increased quantitative or qualitative susceptibility of the young
following in utero (rats and rabbits) and pre-and post-natal exposure
(rats) to clofentezine.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for clofentezine is complete.
    ii. There is no indication that clofentezine is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that clofentezine results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. EPA made conservative (protective) assumptions in the ground
and surface water modeling used to assess exposure to clofentezine in
drinking water. These assessments will not underestimate the exposure
and risks posed by clofentezine.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
clofentezine is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
clofentezine from food and water will utilize less than 1% of the cPAD
for the general U.S. population and all population subgroups. There are
no residential uses for clofentezine.
    3. Short- and Intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Short- and
intermediate-term adverse effects were identified; however,
clofentezine is not registered for any use patterns that would result
in short- or intermediate-term residential exposure. Short- and
intermediate-term risk is assessed based on short- and intermediate-
term residential exposure plus chronic dietary exposure. Because there
is no short- or intermediate-term residential exposure and chronic
dietary exposure has already been assessed under the appropriately
protective cPAD (which is at least as protective as the POD used to
assess short- or intermediate-term risk), no further assessment of
short- or intermediate-term risk is necessary, and EPA relies on the
chronic dietary risk assessment for evaluating short- and intermediate-
term risk for clofentezine.
    4. Aggregate cancer risk for U.S. population. Using the exposure
assumptions described in this unit for cancer exposure, EPA has
concluded that by applying the Q1* of 3.76 x 10-2
(mg/kg/day)-1 to the exposure value results in a cancer risk
estimate of 3.9 x 10-7 for adults. EPA generally considers
cancer risks (expressed as the probability of an increased cancer case)
in the range of 1 in 1 million (or 1 x 10-6) or less to be
negligible.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to clofentezine residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high-performance liquid
chromatography (HPLC)) is available to enforce the tolerance
expression. The limit of quantitation (LOQ) and limit of detection
(LOD) were determined to be 0.01 ppm and 0.003 ppm, respectively.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint

United Nations Food and Agriculture Organization/World Health
Organization food standards program, and it is recognized as an
international food safety standards-setting organization in trade
agreements to which the United States is a party. EPA may establish a
tolerance that is different from a Codex MRL; however, FFDCA section
408(b)(4) requires that EPA explain the reasons for departing from the
Codex level.
    The Codex has not established an MRL for clofentezine on guava.

C. Response to Comments

    One comment was received on the Notice of Filing expressing concern
about pollution in cities due to human waste. The comment did not raise
any issue related to the Agency's safety determination for clofentezine
tolerances. The receipt of this comment is acknowledged; however, this
comment is not relevant to this action.

D. Revisions to Petitioned-For Tolerances

    The Agency is establishing a tolerance for residues of clofentezine
in or on guava at 3 ppm, rather than 1 ppm as requested. The storage
stability data indicated a low average concurrent recovery of residues
in guava. To account for the low storage stability recoveries, the
Agency applied a factor of 3X to the average field trial values,
resulting in a calculation of higher residues on guava and a need for a
higher tolerance level.

V. Conclusion

    Therefore, a tolerance is established for residues of clofentezine,
3,6-bis(2-chlorphenyl)-1,2,4,5-tetrazine, in or on guava at 3 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes a tolerance under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), nor is this action considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). This action does not contain any information collections subject
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
et seq.), nor does it require any special considerations under
Executive Order 12898, entitled ``Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: May 21, 2019.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.446, add alphabetically the entry ``Guava'' to the
table in paragraph (a)(1) to read as follows:

Sec.  180.446  Clofentezine; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                            Parts per
                       Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Guava..................................................               3

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2019-11094 Filed 5-28-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 146 (Thursday, July 30, 2015)]
[Notices]
[Pages 45539-45540]
[FR Doc No: 2015-18727]

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ENVIRONMENTAL PROTECTION AGENCY

[CERCLA-04-2015-3752; FRL-9931-52-Region 4]

Capitol City Plume Superfund Site Montgomery, Montgomery County,
Alabama; Notice of settlement

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of settlement.

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

SUMMARY: Under 122(h) of the Comprehensive Environmental Response,
Compensation and Liability Act (CERCLA), the United States
Environmental Protection Agency (EPA) has entered into a settlement
with multiple parties concerning the Capitol City Plume Superfund Site
located in Montgomery, Montgomery County, Alabama. The settlement
addresses costs from a fund-lead Remedial Investigation performed by
EPA at the Site. The Agency is deferring the Site to the State of
Alabama for cleanup.

DATES: The Agency will consider public comments on the settlement until
August 31, 2015. The Agency will consider all comments received and may
modify or withdraw its consent to the settlement if comments received
disclose facts or considerations which indicate that the amended
settlement is inappropriate, improper, or inadequate.

ADDRESSES: Copies of the settlement are available from the Agency by
contacting Ms. Paula V. Painter, Environmental Protection Specialist
using the contact information provided in this notice. Comments may
also be submitted by referencing the Site's name through one of the
following methods:
     Internet: www.epa.gov/region4/superfund/programs/enforcement/enforcement.html.
     U.S. Mail: U.S. Environmental Protection Agency, Superfund
Division, Attn: Paula V. Painter, 61 Forsyth Street SW., Atlanta,
Georgia 30303.
     Email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Paula V. Painter at<PHONE_NUMBER>.

    Dated: June 9, 2015.
Anita L. Davis,
Chief, Enforcement and Community Engagement Branch, Superfund Division.
[FR Doc. 2015-18727 Filed 7-29-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 74, Number 122 (Friday, June 26, 2009)]
[Rules and Regulations]
[Pages 30463-30464]
[FR Doc No: E9-15152]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2009-N-0665]

Oral Dosage Form New Animal Drugs; Trilostane

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect the supplemental approval of a new animal
drug application (NADA) filed by Dechra, Ltd. The supplemental NADA
provides for the addition of a 10-milligram capsule size of trilostane,
used in dogs for treatment of hyperadrenocorticism.

DATES: This rule is effective June 26, 2009.

FOR FURTHER INFORMATION CONTACT:  Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Dechra, Ltd., Dechra House, Jamage
Industrial Estate, Talke Pits, Stoke-on-Trent, Staffordshire, ST7 1XW,
United Kingdom, filed a supplement to NADA 141-291 that provides for
use of VETORYL (trilostane) Capsules in dogs for treatment of
pituitary-dependent hyperadrenocorticism and for treatment of
hyperadrenocorticism due to adrenocortical tumors. The supplement
provides for the use of a 10-milligram capsule size. The supplemental
NADA is approved as of June 5, 2009, and the regulations are amended in
21 CFR 520.2598 to reflect the approval.
    In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application may be seen in the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33 that this action is of
a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 520

    Animal drugs.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

Sec.  520.2598  [Amended]

0
2. In paragraph (a) of Sec.  520.2598 remove ``30 or 60 milligrams''
and in its place add ``10, 30, or 60 milligrams''.

    Dated: June 19, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E9-15152 Filed 6-25-09; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 88, Number 229 (Thursday, November 30, 2023)]
[Notices]
[Pages 83563-83564]
[FR Doc No: 2023-26280]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4728-DR; Docket ID FEMA-2023-0001]

Illinois; Amendment No. 2 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Illinois (FEMA-4728-DR), dated August 15, 2023, and
related determinations.

DATES: This amendment was issued October 23, 2023.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Illinois is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of August 15, 2023.

    Calhoun and Logan Counties for Public Assistance.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,

Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2023-26280 Filed 11-29-23; 8:45 am]
BILLING CODE 9111-23-P