Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58415

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301064; FRL–6747–8]

RIN 2070–AB78]

Indoxacarb; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

permanent tolerances for the combined

residues of Indoxacarb, [(S)-methyl 7-

chloro-2,5-dihydro-2-

[[(methoxycarbonyl)[4-

(trifluoromethoxy)phenyl]

amino]carbonyl]indeno[1,2-e][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 as follows:

apples, pears, Brassica (head and stem

subgroup), cotton, leaf lettuce, head

lettuce, fruiting vegetable group, sweet

corn, milk, and the meat, meat

byproducts and fat of cattle, goats,

horses, hogs and sheep. E. I. du Pont de

Nemours and Company requested these

tolerances under the Federal Food,

Drug, and Cosmetic Act, as amended by

the Food Quality Protection Act of 1996.

DATES: This regulation is effective

September 29, 2000. Objections and

requests for hearings, identified by

docket control number OPP–301064,

must be received by EPA on or before

November 28, 2000.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, in person, or by courier. Please

follow the detailed instructions for each

method as provided in Unit VI. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301064 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT By

mail: Jane Smith, Registration Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW.,Washington,

DC 20460; telephone number: 703 305–

7378; e-mail address: smith.janescott@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer, or pesticide

manufacturer. Potentially affected

categories and entities may include, but

are not limited to:

Categories NAICS

Examples of Potentially Affected Entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically.You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations,’’ ‘‘Regulations

and Proposed Rules,’’ and then look up

the entry for this document under the

‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/. To access the

OPPTS Harmonized Guidelines

referenced in this document, go directly

to the guidelines at http://www.epa.gov/

opptsfrs/home/guidelin.htm.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–301064. The official record

consists of the documents specifically

referenced in this action, and other

information related to this action,

including any information claimed as

Confidential Business Information (CBI).

This official record includes the

documents that are physically located in

the docket, as well as the documents

that are referenced in those documents.

The public version of the official record

does not include any information

claimed as CBI. The public version of

the official record, which includes

printed, paper versions of any electronic

comments submitted during an

applicable comment period is available

for inspection in the Public Information

and Records Integrity Branch (PIRIB),

Rm. 119, Crystal Mall #2, 1921 Jefferson

Davis Hwy., Arlington, VA, from 8:30

a.m. to 4 p.m., Monday through Friday,

excluding legal holidays. The PIRIB

telephone number is (703) 305–5805.

II. Background and Statutory Findings

In the Federal Register of April 16,

1998 (63 FR 18912–18919) (FRL–5782–

8), EPA issued a notice pursuant to

section 408 of the Federal Food, Drug,

and Cosmetic Act (FFDCA), 21 U.S.C.

346a as amended by the Food Quality

Protection Act of 1996 (FQPA) (Public

Law 104–170) announcing the filing of

a pesticide petition (PP) 8F4948, for

tolerance by E. I. du Pont de Nemours

and Company, P.O. Box 80038,

Wilmington, DE 19880–0038. This

notice included a summary of the

petition prepared by DuPont, the

registrant. There were three comments

in response to the Notice of Filing from

members of the cotton industry. They

expressed concern for the use of

terminology associated with cotton in

the Notice of Filing. These cotton

terminology comments were forwarded

within the Agency to the evaluators of

the cotton portion of the submission

which ultimately did not impact the

interpretation of the submission.

The petition (8F4948) requested that

40 CFR 180.564 be amended by

establishing permanent tolerances for

residues of the insecticide DPX–MP062

(75:25 enantiomeric mixture of

indoxacarb and its R-enantiomer), [R,S)-

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/on

the raw agricultural commodities as

follows: pome fruit at 2.0 parts per

million (ppm), apple pomace at 6.0

ppm, Brassicas, head and stem at 10.0

ppm, cottonseed at 3.0 ppm, cotton gin

trash at 15.0 ppm, leaf lettuce at 20.0

ppm, head lettuce at 7.0 ppm, fruiting

vegetables at 0.70 ppm, sweet corn

kernel at 0.02 ppm, sweet corn forage at

20.0 ppm, and sweet corn stover at 25.0

ppm, meat 0.02 ppm, milk at 0.10 ppm,

cattle kidney at 0.05 ppm; and by

establishing a tolerance for residues of

the insecticide DPX–MP062, (R,S)-

58416 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

methyl 7-chloro-2,5-dihydro-2-

[[(methoxycarbonyl) [4-

(trifluoromethoxy)phenyl]

amino]carbonyl] indeno[1,2-

e][1,3,4]oxadiazine-4a(3H)-carboxylate

and its metabolite (IN-JT333), methyl 7-

chloro-2,5-dihydro-2-[[[4-

(trifluoromethoxy)phenyl]

amino]carbonyl]indeno[1,2-

e][1,3,4]oxadi azine- 4a(3H)-carboxylate,

in/on milk fat at 0.75 ppm and cattle fat

at 0.75 ppm.

Section 408(b)(2)(A)(i) of the 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) 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) 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..’’

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. For

further discussion of the regulatory

requirements of section 408 and a

complete description of the risk

assessment process, see the final rule on

Bifenthrin Pesticide Tolerances (62 FR

62961, November 26, 1997) (FRL–5754–

7).

III. Aggregate Risk Assessment and

Determination of Safety

Consistent with 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, consistent with

section 408(b)(2), for a tolerance for the

combined residues of indoxacarb and its

R-enantiomer in/on the following: apple

at 1.0 ppm; apple, wet pomace at 3.0

ppm; Brassica, head and stem, subgroup

at 5.0 ppm; cattle, goat, horse, sheep and

hog fat at 0.75 ppm; cattle, goat, horse,

sheep and hog meat at 0.03 ppm; cattle,

goat, horse, sheep and hog meat

byproducts at 0.02 ppm; corn, sweet,

forage at 10 ppm; corn, sweet, kernel

plus cob with husk removed at 0.02

ppm; corn, sweet, stover at 15 ppm;

cotton gin byproducts at 15 ppm; cotton,

undelinted seed at 2.0 ppm; lettuce,

head at 4.0 ppm; lettuce, leaf at 10 ppm;

milk at 0.10 ppm; milk fat at 3.0 ppm;

pear at 0.20 ppm; vegetables, fruiting,

group at 0.50 ppm. EPA’s assessment of

exposures and risks associated with

establishing the tolerance 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 nature of the

toxic effects caused by indoxacarb and

its R-enantiomer are discussed in the

following Table 1 as well as the no

observed adverse effect level (NOAEL)

and the lowest observed adverse effect

level (LOAEL) from the toxicity studies

reviewed. DPX–MP062 is a 75:25

mixture of the two enantiomers:

indoxacarb which is insecticidally

active, and its R-enantiomer, which is

insecticidally inactive. DPX–JW062 is a

mixture of these same two enantiomers;

however, they are in a 50:50 ratio.

Toxicology data submitted on DPX–

JW062 were considered relevant and

included in the evaluation.

The technical DPX–MP062 (75:25) is

toxicity category I for acute oral (rat); IV

for acute dermal (rat), inhalation (rats)

and primary dermal irritation (rabbit);

and III for primary eye irritation (rabbit).

The technical is considered a dermal

sensitizer (guinea pig).

TABLE 1. — SUBCHRONIC, CHRONIC, AND OTHER TOXICITY

Guideline No. Study Type Results

870.3100 90–Day oral toxicity rodents — rats DPX—MP062 (75% indoxacarb / 25% enantiomer) NOAEL = Male

(M) 3.1 mg/kg/day, Female (F) 2.1 mg/kg/day LOAEL = M 6.0

mg/kg/day, F 3.8 mg/kg/day based on decreased body weight,

body weight gain, food consumption and food efficiency.

870.3100 90–Day oral toxicity rodents—rats DPX—JW062 (50% indoxacarb / 50% enantiomer) / NOAEL = M

8.0, F 4.6 mg/kg/day LOAEL = M 16, F 9.5 mg/kg/day based on

mortality (F only), decreased. body weight, body weight gain,

food consumption and food efficiency in rats.

870.3100 90–Day oral toxicity rodents— rats DPX—JW062 / NOAEL = M 3.7, F 4.9 mg/kg/day LOAEL = M 7.5,

F 12 mg/kg/day based on decreased in absolute body weight,

body weight gain and food efficiency in rats.

870.3100 90–Day oral toxicity rodents— mice DPX—JW062 / NOAEL = M23, F 16 mg/kg/day LOAEL = M 44, F

30 mg/kg/day based on mortality (M 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) (F only) in mice.

870.3150 90–Day oral toxicity in nonrodents—dogs DPX—JW062 / NOAEL = 5.0 mg/kg/day LOAEL = 19 mg/kg/day

based on hemolytic anemia, as indicated by decreased in HGB,

RBCs; increases in platelets, increased reticulocytes; and secondary histopathologic findings indicative of blood breakdown

(pigment in Kupffer cells, renal tubular epithelium, and spleen

and bone marrow macrophages); increased in splenic EMH; and

RBC hyperplasia in bone marrow in dogs.

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58417

TABLE 1. — SUBCHRONIC, CHRONIC, AND OTHER TOXICITY—Continued

Guideline No. Study Type Results

870.3200 28–Day dermal toxicity — rats DPX—MP062 / NOAEL = 2,000 mg/kg/day LOAEL = >2,000 mg/kg/

day in rats.

870.3200 28–Day dermal toxicity — rats DPX—MP062 / NOAEL = 50 mg/kg/day LOAEL = 500 mg/kg/day

based on decreased body weights, body weight gains, food consumption, and food efficiency in F, and changes in hematology

parameters (increased reticulocytes), the spleen (increased absolute and relative weight M only, gross discoloration), clinical signs

of toxicity in both sexes in rats.

870.3700a Prenatal developmental in rodents—rats DPX—MP062 / Maternal NOAEL = 2.0 mg/kg/day, LOAEL = 4.0

mg/kg/day based on decreased mean body weights, body weight

gains, food consumption. Developmental NOAEL = 2.0 mg/kg/

day, LOAEL = 4.0 mg/kg/day based on decreased fetal weights.

870.3700a Prenatal developmental in rodents—rats DPX—JW062 / Maternal NOAEL = 10 mg/kg/day, LOAEL = 100

mg/kg/day based on mortality, clinical signs, and decreased

mean body weights, body weight gains, and food consumption.

Developmental NOAEL = 10 mg/kg/day, LOAEL = 100 mg/kg/day

based on decreased numbers of live fetuses/litter.

870.3700a Prenatal developmental in rodents—rats DPX—JW062 / Maternal NOAEL = 1.1 mg/kg/day LOAEL = 2.2

mg/kg/day based on decreased mean body weights, body weight

gains, food consumption, and food efficiency. Developmental

NOAEL = 1.1 mg/kg/day LOAEL = 2.2 mg/kg/day based on decreased fetal body weights.

870.3700b Prenatal developmental in nonrodents—rabbits DPX—JW062 / Maternal NOAEL = 500 mg/kg/day LOAEL = 1,000

mg/kg/day based on slight decreases in maternal body weight

gain and food consumption. Developmental NOAEL = 500 mg/kg/

day LOAEL = 1,000 mg/kg/day based on decr. fetal body weights

and reduced ossification of the sternebrae.

870.3800 Reproduction and fertility effects—rats DPX—JW062 / Parental/Systemic NOAEL = 1.5 mg/kg/day LOAEL

= 4.4 mg/kg/ day based on decreased. body weights, body

weight gains, and food consumption of F0 females, and increased

spleen weights in the F0 and F1 females. Reproductive NOAEL =

6.4 mg/kg/day, LOAEL > 6.4 mg/kg/day. Offspring NOAEL = 1.5

mg/kg/day, LOAEL = 4.4 mg/kg/day based on decreased in the

body weights of the F1 pups during lactation.

870.4100a Chronic toxicity rodents—rats DPX—JW062 / NOAEL = M 5, F 2.1 mg/kg/day, LOAEL = M 10, F

3.6 mg/kg/day based on decreased body weight, body weight

gain, and food consumption and food efficiency; decreased HCT,

HGB and RBC at 6 months in F only. no evidence of carcinogenic potential

870.4100b Chronic toxicity—dogs DPX—JW062 / NOAEL = M 2.3, F 2.4 mg/kg/day LOAEL = M 18,

F 19 mg/kg/day based on decreased. HCT, HGB and RBC; increased Heinz bodies and reticulocytes and associated secondary microscopic changes in the liver, kidneys, spleen, and

bone marrow; increased absolute and relative liver weights.

870.4200 Carcinogenicity—rats DPX—JW062 / see 870.4100a no evidence of carcinogenicity

870.4300 Carcinogenicity—mice DPX—JW062 / NOAEL = M 2.6, F4.0 mg/kg/day, LOAEL = M 14, F

20 mg/kg/day based on decreased body weight, body weight

gain, and food efficiency and clinical signs indicative of

neurotoxicity. no evidence of carcinogenicity

870.5100 Gene mutation DPX—MP062 / strains TA97a, TA98, TA100 and TA1535 of S.

typhimurium and strain WP2(uvrA) of E. coli were negative for

mutagenic activity both with and without S9 activation for the

concentration range 10–5000 μg/plate

870.5100 Gene mutation DPX—JW062 / strains TA97a, TA98, TA100 and TA1535 of S.

typhimurium and strain WP2(uvrA) of E. coli were negative for

mutagenic activity both with and without S9 activation for the

concentration range 10–5000 μg/plate.

58418 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

TABLE 1. — SUBCHRONIC, CHRONIC, AND OTHER TOXICITY—Continued

Guideline No. Study Type Results

870.5300 Gene mutation DPX—MP062 / negative for mutagenic activity for the following

concentration ranges: 3.1–250 μg/mL (–S9); 3.1–250 μg/mL

(+S9)

870.5300 Gene mutation DPX—JW062 / negative for mutagenic activity for the following concentration ranges: Negative;100–1,000 μg/mL (–S9); 100–1,000

μg/mL (+S9), precipitate ≥1,000 μg/mL

870.5375 Cytogenetics DPX—MP062 / no evidence of chromosomal aberrations induced

by the test article over background for the following concentration

ranges: 15.7–1,000 μg/mL (+S9)

870.5375 Cytogenetics DPX—JW062 / no evidence of chromosomal aberrations induced

by the test article over background for the following concentration

ranges: 19–300 μg/mL (–S9), 19–150 μg/mL (+S9); partial insoluble and cytotoxicity ≥150 μg/mL

870.5395 Cytogenetics DPX—MP062 / no evidence of mutagenicity for the following dose

ranges: 3,000–4,000 mg/kg—males; 1,000–2,000 mg/kg—females

870.5395 Cytogenetics DPX—JW062 / no evidence of mutagenicity at 2,500 or 5,000 mg/

kg

870.5550 Other effects DPX—MP062/ no evidence of mutagenic activity at the following

concentration range: 1.56–200 μg/mL; cytotoxicity was seen at

concentrations of ≥100 μg/mL

870.5550 Other effects DPX—JW062 / No evidence of mutagenic activity at the following

concentration range: 0.1–50 μg/mL, cytotoxicity observed at ≥50

μg/mL

870.6200a Acute neurotoxicity screening battery — rat DPX—MP062 / NOAEL = M 100, F 12.5 mg/kg LOAEL = M 200

mg/kg based on decreased body weight gain, decreased food

consumption, decreased forelimb grip strength, and decreased

foot splay. F 50 mg/kg based on decreased body weight, body

weight gain, and food consumption

870.6200a Acute neurotoxicity screening battery —rats DPX—JW062 / NOAEL >= M 2,000 mg/kg, F < 500 mg/kg LOAEL

> M 2,000 mg/kg, F < 500 mg/kg based on clinical signs, decreased body weight gains and food consumption, and FOB effects

870.6200b Subchronic neurotoxicity screening battery — rats DPX—MP062 / NOAEL = M 0.57, F 0.68 mg/kg/day LOAEL = M

5.6, F 3.3 mg/kg/day based on decreased body weight and alopecia.

870.7485 Metabolism and pharmacokinetic — rats Both DPX—MP062 and DPX—JW062 were extensively metabolized and the metabolites were eliminated in urine, feces, and

bile. The metabolite profile for DPX—JW062 was dose dependent and varied quantitatively between males and females. Differences in metabolite profiles were also observed for the different label positions (indanone and trifluoromethoxyphenyl

rings). All biliary metabolites undergo further biotransformation in

the gut. The proposed metabolic pathway for both DPX—MP062

and DPX—JW062 has multiple metabolites bearing one of the

two ring structures.

B. Toxicological Endpoints

The dose at which no adverse effects

are observed (the NOAEL) from the

toxicology study identified as

appropriate for use in risk assessment is

used to estimate the toxicological level

of concern (LOC). However, the lowest

dose at which adverse effects of concern

are identified (the LOAEL) is sometimes

used for risk assessment if no NOAEL

was achieved in the toxicology study

selected. An uncertainty factor (UF) is

applied to reflect uncertainties inherent

in the extrapolation from laboratory

animal data to humans and in the

variations in sensitivity among members

of the human population as well as

other unknowns. An UF of 100 is

routinely used, 10X to account for

interspecies differences and 10X for

intraspecies differences.

For dietary risk assessment (other

than cancer) the Agency uses the UF to

calculate an acute or chronic reference

dose (acute RfD or chronic RfD) where

the RfD is equal to the NOAEL divided

by the appropriate UF (RfD = NOAEL/

UF). Where an additional safety factor is

retained due to concerns unique to the

FQPA, this additional factor is applied

to the RfD by dividing the RfD by such

additional factor. The acute or chronic

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58419

Population Adjusted Dose (aPAD or

cPAD) is a modification of the RfD to

accommodate this type of FQPA Safety

Factor.

For non-dietary risk assessments

(other than cancer) the UF is used to

determine the LOC. For example, when

100 is the appropriate UF (10X to

account for interspecies differences and

10X for intraspecies differences) the

LOC is 100. To estimate risk, a ratio of

the NOAEL to exposures (margin of

exposure (MOE) = NOAEL/exposure) is

calculated and compared to the LOC.

The linear default risk methodology

(Q*) is the primary method currently

used by the Agency to quantify

carcinogenic risk. The Q* approach

assumes that any amount of exposure

will lead to some degree of cancer risk.

A Q* is calculated and used to estimate

risk which represents a probability of

occurrence of additional cancer cases

(e.g., risk is expressed as 1 x 10-6 or one

in a million). Under certain specific

circumstances, MOE calculations will

be used for the carcinogenic risk

assessment. In this non-linear approach,

a ‘‘point of departure’’ is identified

below which carcinogenic effects are

not expected. The point of departure is

typically a NOAEL based on an

endpoint related to cancer effects

though it may be a different value

derived from the dose response curve.

To estimate risk, a ratio of the point of

departure to exposure (MOEcancer = point

of departure/exposures) is calculated. A

summary of the toxicological endpoints

for indoxacarb and its R-enantiomer

used for human risk assessment is

shown in the following Table 2:

TABLE 2. — SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR INDOXACARB AND ITS R-ENANTIOMER FOR USE IN

HUMAN RISK ASSESSMENT

Exposure Scenario Dose Used in Risk Assessment, Uncertainty Factor (UF)

FQPA Safety Factor (SF)* and

Endpoint for Risk Assessment Study and Toxicological Effects

Acute dietary females 13–50

years of age

NOAEL = 2.0 mg/kg/day UF =

100 Acute RfD = 0.02 mg/

kg

FQPA SF = 1 aPAD = acute

RfD ÷ FQPA SF = 0.02 mg/

kg/day

Developmental rat toxicity study. developmental LOAEL = 4.0 mg/kg/day based on

decreased fetal body weight.

Acute dietary general population including infants and

children

NOAEL= 12.5 mg/kg UF =

100 Acute RfD = 0.12 mg/

kg

FQPA SF = 1 aPAD = acute

RfD ÷ FQPA SF = 0.12 mg/

kg/day

Acute oral rat neurotoxicity study. LOAEL =

50 mg/kg based on decreased body weight

and body weight gain in females.

Chronic dietary all populations NOAEL= 2.0 mg/kg/day UF =

100 Chronic RfD = 0.02 mg/

kg/day

FQPA SF = 1 cPAD = chr RfD

÷ FQPA SF = 0.02 mg/kg/

day

90–Day rat subchronic toxicity study, 90–day

rat neurotoxicity study, chronic/carcinogenicity rat study. LOAEL = 3.3 mg/kg/day

based on decreased body weight, alopecia,

body weight gain, food consumption and

food efficiency; decreased hematocrit, hemoglobin and red blood cells only at 6

months. 3.3 mg/kg/day is the lowest

NOAEL/LOAEL of the 3 studies.

Short-term oral (1–7 days)

(Residential)

Oral study NOAEL= 2.0 mg/

kg/day

LOC for MOE = 100 (Residential, includes the FQPA SF)Developmental rat toxicity study. maternal

LOAEL = 4.0 mg/kg/day based on decreased mean maternal body weights, body

weight gains, and food consumption.

Intermediate- term oral (1

week - several months)

(Residential)

Oral study NOAEL= 2.0 mg/

kg/day

LOC for MOE = 100 (Residential, includes the FQPA SF)90–day rat subchronic toxicity study. LOAEL

= 3.8 mg/kg/day based on decreased body

weight, body weight gain, food consumption and food efficiency.

Short- (1–7 days),

intermediate- (1 week—several months), and long-

(several months—lifetime)

term dermal (Occupational/

Residential)

Dermal study NOAEL= 50 mg/

kg/day

LOC for MOE = 100 (Occupational) LOC for MOE = 100

(Residential, includes the

FQPA SF)

28–day rat dermal toxicity study. LOAEL =

500 mg/kg/day based on decreased body

weights, body weight gains, food consumption, and food efficiency in females, and

changes in hematology parameters (increased reticulocytes), the spleen (increased absolute and relative weight males

only, gross discoloration), and clinical signs

of toxicity in both sexes.

Short-term inhalation (1–7

days) (Occupational/ Residential)

Oral study NOAEL= 2.0 mg/

kg/day (inhalation absorption rate = 100%)

LOC for MOE = 100 (Occupational) LOC for MOE = 100

(Residential, includes the

FQPA SF)

Rat developmental toxicity study. maternal

LOAEL = 4.0 mg/kg/day based on decreased mean maternal body weights, body

weight gains, and food consumption.

Intermediate- term inhalation

(1 week—several months)

(Occupational/ Residential)

Oral study NOAEL= 2.0 mg/

kg/day (inhalation absorption rate = 100%)

LOC for MOE = 100 (Occupational) LOC for MOE = 100

(Residential, includes the

FQPA SF)

90–day rat subchronic toxicity study. LOAEL

= 3.8 mg/kg/day based on decreased body

weight, body weight gain, food consumption and food efficiency.

58420 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

TABLE 2. — SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR INDOXACARB AND ITS R-ENANTIOMER FOR USE IN

HUMAN RISK ASSESSMENT—Continued

Exposure Scenario Dose Used in Risk Assessment, Uncertainty Factor (UF)

FQPA Safety Factor (SF)* and

Endpoint for Risk Assessment Study and Toxicological Effects

Long-term inhalation (several

months—lifetime)

(Occupational/ Residential)

Oral study NOAEL= 2.0 mg/

kg/day (inhalation absorption rate =100%)

LOC for MOE = 100 (Occupational) LOC for MOE = 100

(Residential, includes the

FQPA SF)

90–day rat subchronic toxicity study, 90–day

rat neurotoxicity study, chronic/carcinogenicity rat study. LOAEL = 3.3 mg/kg/day

based on decreased body weight, body

weight gain, food consumption and food efficiency; decreased hematocrit, hemoglobin

and red blood cells only at 6 months.

Cancer (oral, dermal, inhalation)‘‘not likely’’ to be carcinogenic

to humans

N/A No evidence of carcinogenicity in either the

rat or mouse in acceptable carcinogenicity

studies and no evidence of mutagenicity.

*The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique to the FQPA.

C. Exposure Assessment

1. Dietary exposure from food and

feed uses. Tolerances have been

established (40 CFR 180.564) for the

combined residues or residues of

indoxacarb and its R-enantiomer, in or

on a variety of raw agricultural

commodities including apples, pears,

Brassica (head and stem subgroup),

cotton, leaf lettuce, head lettuce, fruiting

vegetable group, sweet corn, milk, and

the meat, meat byproducts and fat of

cattle, goats, horses, hogs and sheep.

Risk assessments were conducted by

EPA to assess dietary exposures from

indoxacarb and its R-enantiomer in food

as follows:

i. Acute exposure. Acute dietary risk

assessments are performed for a fooduse pesticide if a toxicological study has

indicated the possibility of an effect of

concern occurring as a result of a one

day or single exposure. The Dietary

Exposure Evaluation Model (DEEM)

analysis evaluated the individual food

consumption as reported by

respondents in the USDA 1989–1992

nationwide Continuing Surveys of Food

Intake by Individuals (CSFII) and

accumulated exposure to the chemical

for each commodity. The following

assumptions were made for the acute

exposure assessments: acute Tier 1

analysis assuming tolerance level

residues and 100% crop treated (CT)

information was performed; however,

dietary risk estimates from residues in

food exceeded Agency’s level of concern

(> 100% aPAD). An acute Tier 2

(partially refined analysis) dietary

assessment was performed with use of

anticipated residues (ARs) from field

trial data, processing factors (where

applicable), and 100% CT. Note that the

Tier 2 assessment is deterministic in

that point estimates were used for all

residues and the conservative

assumption of 100% CT was made.

Additional refinement using % CT data

would result in even lower exposure

estimates from residues in food.

ii. Chronic exposure. In conducting

this chronic dietary risk assessment, the

DEEM analysis evaluated the individual

food consumption as reported by

respondents in the USDA 1989–1992

nationwide CSFII and accumulated

exposure to the chemical for each

commodity. The following assumptions

were made for the chronic exposure

assessments: tolerance level residues

and 100% CT (Tier 1). Additional

refinement using less than 100% CT

data would result in even lower

exposure estimates from residues in

food.

iii. Anticipated residue and percent

crop treated Information. Section

408(b)(2)(E) authorizes EPA to use

available data and information on the

anticipated residue levels of pesticide

residues in food and the actual levels of

pesticide chemicals that have been

measured in food. If EPA relies on such

information, EPA must require 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.

Following the initial data submission,

EPA is authorized to require similar

data on a time frame it deems

appropriate. As required by section

408(b)(2)(E), EPA will issue a data callin for information relating to anticipated

residues to be submitted no later than 5

years from the date of issuance of this

tolerance.

2. Dietary exposure from drinking

water. The Agency lacks sufficient

monitoring exposure data to complete a

comprehensive dietary exposure

analysis and risk assessment for

indoxacarb and its R-enantiomer in

drinking water. Because the Agency

does not have comprehensive

monitoring data, drinking water

concentration estimates are made by

reliance on simulation or modeling

taking into account data on the physical

characteristics of indoxacarb and its Renantiomer.

The Agency uses the Generic

Estimated Environmental Concentration

(GENEEC) or the Pesticide Root Zone/

Exposure Analysis Modeling System

(PRZM/EXAMS) to estimate pesticide

concentrations in surface water and the

Screening Concentration in Ground

Water Model (SCI–GROW), which

predicts pesticide concentrations in

ground water. In general, EPA will use

GENEEC (a Tier 1 model) before using

PRZM/EXAMS (a Tier 2 model) for a

screening-level assessment for surface

water. The GENEEC model is a subset of

the PRZM/EXAMS model that uses a

specific high-end runoff scenario for

pesticides. GENEEC incorporates a farm

pond scenario, while PRZM/EXAMS

incorporate an index reservoir

environment in place of the previous

pond scenario. The PRZM/EXAMS

model includes a percent crop area

factor as an adjustment to account for

the maximum percent crop coverage

within a watershed or drainage basin.

None of these models include

consideration of the impact processing

(mixing, dilution, or treatment) of raw

water for distribution as drinking water

would likely have on the removal of

pesticides from the source water. The

primary use of these models by the

Agency at this stage is to provide a

coarse screen for sorting out pesticides

for which it is highly unlikely that

drinking water concentrations would

ever exceed human health levels of

concern.

Since the models used are considered

to be screening tools in the risk

assessment process, the Agency does

not use estimated environmental

concentrations (EECs) from these

models to quantify drinking water

exposure and risk as a %RfD or %PAD.

Instead drinking water levels of

comparison (DWLOCs) are calculated

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58421

and used as a point of comparison

against the model estimates of a

pesticide’s concentration in water.

DWLOCs are theoretical upper limits on

a pesticide’s concentration in drinking

water in light of total aggregate exposure

to a pesticide in food, and from

residential uses. Since DWLOCs address

total aggregate exposure to indoxacarb

and its R-enantiomer they are further

discussed in the aggregate risk sections

below.

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 3.81

parts per billion (ppb) for surface water

and 0.02 ppb for ground water. The

EECs for chronic exposures are

estimated to be 0.56 ppb for surface

water and 0.02 ppb for ground water.

3. From non-dietary exposure. The

term ‘‘residential exposure’’ is used in

this document to refer to nonoccupational, non-dietary exposure

(e.g., for lawn and garden pest control,

indoor pest control, termiticides, and

flea and tick control on pets).

Indoxacarb and its R-enantiomer is not

registered for use on any sites that

would result in residential exposure.

4. Cumulative exposure to substances

with a common mechanism of toxicity.

Section 408(b)(2)(D)(v) 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 does not have, at this time,

available data to determine whether

indoxacarb and its R-enantiomer has a

common mechanism of toxicity with

other substances or how to include this

pesticide in a cumulative risk

assessment. Unlike other pesticides for

which EPA has followed a cumulative

risk approach based on a common

mechanism of toxicity, indoxacarb and

its R-enantiomer does not appear to

produce a toxic metabolite produced by

other substances. For the purposes of

this tolerance action, therefore, EPA has

not assumed that indoxacarb and its Renantiomer has 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 the final rule for

Bifenthrin Pesticide Tolerances (62 FR

62961, November 26, 1997).

D. Safety Factor for Infants and

Children

1. Safety factor for infants and

children—i. In general. FFDCA section

408 provides that EPA shall apply an

additional tenfold 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 data base on

toxicity and exposure unless EPA

determines that a different margin of

safety will be safe for infants and

children. Margins of safety are

incorporated into EPA risk assessments

either directly through use of a margin

of exposure (MOE) analysis or through

using uncertainty (safety) factors in

calculating a dose level that poses no

appreciable risk to humans.

ii. Prenatal and postnatal sensitivity.

There is no evidence of susceptibility

from either in utero or neonatal

exposure to both rat and rabbit young

with either DPX—MP062 or DPX—

JW062.

iii. Conclusion. There is a complete

toxicity data base for indoxacarb and its

R-enantiomer and exposure data are

complete or are estimated based on data

that reasonably accounts for potential

exposures. The FQPA safety factor is

1X. EPA determined that the 10X safety

factor to protect infants and children

should be removed because, there is no

indication of quantitative or qualitative

increased susceptibility of rats or rabbits

to in utero and/or postnatal exposure;

the requirement of a developmental

neurotoxicity study is not based on the

criteria reflecting special concern for the

developing fetuses or young which are

generally used for requiring a DNT

study—and a safety factor (e.g.:

neuropathy in adult animals; CNS

malformations following prenatal

exposure; brain weight or sexual

maturation changes in offspring; and/or

functional changes in offspring)—and

therefore does not warrant an FQPA SF;

the dietary (food and drinking water)

exposure assessments will not under

estimate the potential exposures for

infants and children; and there are no

registered residential uses at the current

time.

E. Aggregate Risks and Determination of

Safety

To estimate total aggregate exposure

to a pesticide from food, drinking water,

and residential uses, the Agency

calculates DWLOCs which are used as a

point of comparison against the model

estimates of a pesticide’s concentration

in water (EECs). DWLOC values are not

regulatory standards for drinking water.

DWLOCs are theoretical upper limits on

a pesticide’s concentration in drinking

water in light of total aggregate exposure

to a pesticide in food and residential

uses. In calculating a DWLOC, the

Agency determines how much of the

acceptable exposure (i.e., the PAD) is

available for exposure through drinking

water [e.g., allowable chronic water

exposure (mg/kg/day) = cPAD—(average

food + residential exposure)]. This

allowable exposure through drinking

water is used to calculate a DWLOC.

A DWLOC will vary depending on the

toxic endpoint, drinking water

consumption, and body weights. Default

body weights and consumption values

as used by the U S EPA Office of Water

are used to calculate DWLOCs: 2L/70 kg

(adult male), 2L/60 kg (adult female),

and 1L/10 kg (child). Default body

weights and drinking water

consumption values vary on an

individual basis. This variation will be

taken into account in more refined

screening-level and quantitative

drinking water exposure assessments.

Different populations will have different

DWLOCs. Generally, a DWLOC is

calculated for each type of risk

assessment used: acute, short-term,

intermediate-term, chronic, and cancer.

When EECs for surface water and

ground water are less than the

calculated DWLOCs, OPP concludes

with reasonable certainty that exposures

to the pesticide in drinking water (when

considered along with other sources of

exposure for which OPP has reliable

data) would not result in unacceptable

levels of aggregate human health risk at

this time. Because OPP considers the

aggregate risk resulting from multiple

exposure pathways associated with a

pesticide’s uses, levels of comparison in

drinking water may vary as those uses

change. If new uses are added in the

future, OPP will reassess the potential

impacts of residues of the pesticide in

drinking water as a part of the aggregate

risk assessment process.

1. Acute risk. Using the exposure

assumptions discussed in this unit for

acute exposure, the acute dietary

exposure from food only to indoxacarb

and its R-enantiomer will occupy < or

= 10% of the aPAD for the U.S.

population, 33% of the aPAD for

females 13 years and older, 6% of the

aPAD for infants < 1 year and 10% of

the aPAD for children 1–6 years old. In

addition, there is potential for acute

dietary exposure to indoxacarb and its

R-enantiomer in drinking water. After

calculating DWLOCs and comparing

them to the EECs for surface and ground

water, EPA does not expect the

aggregate exposure to exceed 100% of

the aPAD as shown in the following

Table 3:

58422 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

TABLE 3. — AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO INDOXACARB AND ITS R-ENANTIOMER.

Scenario / Population Subgroup aPAD (mg/

kg/day) % aPAD

Surface

Water EEC

(ppb)

Ground

Water EEC

(ppb)

Acute

DWLOC

(ppb)

Females 13–50 years old 0.02 33 3.81 0.02 3,400

General U.S. Population 0.12 6 3.81 0.02 4,000

All Infants < 1 year old 0.12 6 3.81 0.02 1,100

Children 1–6 years old 0.12 10 3.81 0.02 1,100

Children 7–12 years old 0.12 7 3.81 0.02 1,100

2. Chronic risk. Using the exposure

assumptions described in this unit for

chronic exposure, EPA has concluded

that exposure to indoxacarb and its Renantiomer from food will utilize 28%

of the cPAD for the U.S. population,

37% of the cPAD for infants <1 year old,

and 73% of the cPAD for children 1–6

years old. There are no residential uses

for indoxacarb and its R-enantiomer that

result in chronic residential exposure to

indoxacarb and its R-enantiomer. In

addition, there is potential for chronic

dietary exposure to indoxacarb and its

R-enantiomer in drinking water. After

calculating the DWLOCs and comparing

them to the EECs for surface and ground

water, EPA does not expect the

aggregate exposure to exceed 100% of

the cPAD, as shown in the following

Table 4:

TABLE 4. — AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO INDOXACARB AND ITS RENANTIOMER

Population Subgroup cPAD mg/

kg/day

% cPAD

(Food)

Surface

Water EEC

(ppb)

Ground

Water EEC

(ppb)

Chronic

DWLOC

(ppb)

U.S. Population 0.12 28 0.56 0.02 500

All Infants <1 year old 0.12 37 0.56 0.02 130

Children 1–6 years old 0.12 73 0.56 0.02 53

Children 7–12 years old 0.12 40 0.56 0.02 120

Females 13–50 years old 0.12 22 0.56 0.02 540

3. Short-term risk. Short-term

aggregate exposure takes into account

residential exposure plus chronic

exposure to food and water (considered

to be a background exposure level).

Indoxacarb and its r- enantiomer is not

registered for use on any sites that

would result in residential exposure.

Therefore, the aggregate risk is the sum

of the risk from food and water do not

exceed the Agency’s level of concern.

4. Intermediate-term risk.

Intermediate-term aggregate exposure

takes into account residential exposure

plus chronic exposure to food and water

(considered to be a background

exposure level). Indoxacarb and its Renantiomer is not registered for use on

any sites that would result in residential

exposure. Therefore, the aggregate risk

is the sum of the risk from food and

water, which do not exceed the

Agency’s level of concern.

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, and to infants and children

from aggregate exposure to indoxacarb

and its R-enantiomer residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology

(example: gas chromotography) is

available to enforce the tolerance

expression. The method may be

requested from: Calvin Furlow, PRRIB,

IRSD (7502C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW,

Washington, DC 20460; telephone

number: (703) 305–5229; e-mail address:

furlow.calvin@epa.gov.

B. International Residue Limits

No other international residue limits

have been established at this time.

C. Conditions

The following toxicology studies are

required as confirmatory: a

developmental neurotoxicity study in

the rat (Guideline #870.6300) and a 90–

day inhalation toxicity study in the rat

(Guideline #870.3465).

V. Conclusion

Therefore, the tolerance is established

for combined residues of indoxacarb

[(S)-methyl 7-chloro-2,5-dihydro-2-

[[(methoxycarbonyl)[4-

(trifluoromethoxy)phenyl]

amino]carbonyl] indeno[1,2-

e][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 or on the following raw agricultural

commodities: at 1.0 ppm; apple, wet

pomace at 3.0 ppm; Brassica, head and

stem, subgroup at 5.0 ppm; cattle, goat,

horse, sheep and hog fat at 0.75 ppm;

cattle, goat, horse, sheep and hog meat

at 0.03 ppm; cattle, goat, horse, sheep

and hog meat byproducts at 0.02 ppm;

corn, sweet, forage at 10 ppm; corn,

sweet, kernel plus cob with husk

removed at 0.02 ppm; corn, sweet,

stover at 15 ppm; cotton gin byproducts

at 15 ppm; cotton, undelinted seed at

2.0 ppm; lettuce, head at 4.0 ppm;

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58423

lettuce, leaf at 10 ppm; milk at 0.10

ppm; milk fat at 3.0 ppm; pear at 0.20

ppm; and vegetables, fruiting, group at

0.50 ppm.

VI. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as

amended by the FQPA, any person may

file an objection to any aspect of this

regulation and may also request a

hearing on those objections. The EPA

procedural regulations which govern the

submission of objections and requests

for hearings appear in 40 CFR part 178.

Although the procedures in those

regulations require some modification to

reflect the amendments made to the

FFDCA by the FQPA of 1996, EPA will

continue to use those procedures, with

appropriate adjustments, until the

necessary modifications can be made.

The new section 408(g) provides

essentially the same process for persons

to ‘‘object’’ to a regulation for an

exemption from the requirement of a

tolerance issued by EPA under new

section 408(d), as was provided in the

old FFDCA sections 408 and 409.

However, the period for filing objections

is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an

Objection or Request a Hearing?

You must file your objection or

request a hearing on this regulation in

accordance with the instructions

provided in this unit and in 40 CFR part

178. To ensure proper receipt by EPA,

you must identify docket control

number OPP–301064 in the subject line

on the first page of your submission. All

requests must be in writing, and must be

mailed or delivered to the Hearing Clerk

on or before November 28, 2000.

1. Filing the request. Your objection

must specify the specific provisions in

the regulation that you object to, and the

grounds for the objections (40 CFR

178.25). If a hearing is requested, the

objections must include a statement of

the factual issues(s) on which a hearing

is requested, the requestor’s contentions

on such issues, and a summary of any

evidence relied upon by the objector (40

CFR 178.27). Information submitted in

connection with an objection or hearing

request may be claimed confidential by

marking any part or all of that

information as CBI. Information so

marked will not be disclosed except in

accordance with procedures set forth in

40 CFR part 2. A copy of the

information that does not contain CBI

must be submitted for inclusion in the

public record. Information not marked

confidential may be disclosed publicly

by EPA without prior notice.

Mail your written request to: Office of

the Hearing Clerk (1900), Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460. You

may also deliver your request to the

Office of the Hearing Clerk in Rm. C400,

Waterside Mall, 401 M St., SW.,

Washington, DC 20460. The Office of

the Hearing Clerk is open from 8 a.m.

to 4 p.m., Monday through Friday,

excluding legal holidays. The telephone

number for the Office of the Hearing

Clerk is (202) 260–4865.

2. Tolerance fee payment. If you file

an objection or request a hearing, you

must also pay the fee prescribed by 40

CFR 180.33(i) or request a waiver of that

fee pursuant to 40 CFR 180.33(m). You

must mail the fee to: EPA Headquarters

Accounting Operations Branch, Office

of Pesticide Programs, P.O. Box

360277M, Pittsburgh, PA 15251. Please

identify the fee submission by labeling

it ‘‘Tolerance Petition Fees.’’

EPA is authorized to waive any fee

requirement ‘‘when in the judgement of

the Administrator such a waiver or

refund is equitable and not contrary to

the purpose of this subsection.’’ For

additional information regarding the

waiver of these fees, you may contact

James Tompkins by phone at (703) 305–

5697, by e-mail at

tompkins.jim@epa.gov, or by mailing a

request for information to Mr. Tompkins

at Registration Division (7505C), Office

of Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

If you would like to request a waiver

of the tolerance objection fees, you must

mail your request for such a waiver to:

James Hollins, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

3. Copies for the Docket. In addition

to filing an objection or hearing request

with the Hearing Clerk as described in

Unit VI.A., you should also send a copy

of your request to the PIRIB for its

inclusion in the official record that is

described in Unit I.B.2. Mail your

copies, identified by docket control

number OPP–301064, to: Public

Information and Records Integrity

Branch, Information Resources and

Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460. In

person or by courier, bring a copy to the

location of the PIRIB described in Unit

I.B.2. You may also send an electronic

copy of your request via e-mail to: oppdocket@epa.gov. Please use an ASCII

file format and avoid the use of special

characters and any form of encryption.

Copies of electronic objections and

hearing requests will also be accepted

on disks in WordPerfect 6.1/8.0 file

format or ASCII file format. Do not

include any CBI in your electronic copy.

You may also submit an electronic copy

of your request at many Federal

Depository Libraries.

B. When Will the Agency Grant a

Request for a Hearing?

A request for a hearing will be granted

if the Administrator determines that the

material submitted shows the following:

There is a genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

VII. Regulatory Assessment

Requirements

This final rule 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). This final rule does

not contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44

U.S.C. 3501 et seq., or impose any

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA) (Public

Law 104–4). Nor does it require any

prior consultation as specified by

Executive Order 13084, entitled

Consultation and Coordination with

Indian Tribal Governments (63 FR

27655, May 19, 1998); special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994); or require OMB review or any

Agency action under Executive Order

13045, entitled Protection of Children

from Environmental Health Risks and

Safety Risks (62 FR 19885, April 23,

1997). 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 of 1995

(NTTAA), Public Law 104–113, section

12(d) (15 U.S.C. 272 note). Since

tolerances and exemptions that are

established on the basis of a petition

58424 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

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. In addition, the

Agency has determined that this action

will not have a substantial direct effect

on 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, as specified in

Executive Order 13132, entitled

Federalism (64 FR 43255, August 10,

1999). Executive Order 13132 requires

EPA to develop an accountable process

to ensure ‘‘meaningful and timely input

by State and local officials in the

development of regulatory policies that

have federalism implications.’’ ‘‘Policies

that have federalism implications’’ is

defined in the Executive Order to

include regulations that have

‘‘substantial direct effects 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.’’ This final rule

directly regulates growers, food

processors, food handlers and food

retailers, not States. This action does not

alter the relationships or distribution of

power and responsibilities established

by Congress in the preemption

provisions of FFDCA section 408(n)(4).

VIII. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. 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 this final

rule in the Federal Register. This final

rule 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: September 21, 2000.

Susan B. Hazen,

Acting Director, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

371.

2. Section 180.564 is added to read as

follows:

§ 180.564 Indoxacarb; tolerances for

residues.

(a) General. Tolerances are

established for the combined residues of

the insecticide indoxacarb [(S)-methyl

7-chloro-2,5-dihydro-2-

[[(methoxycarbonyl)[4-

(trifluoromethoxy)phenyl]

amino]carbonyl]indeno[1,2-

e][1,3,4]oxadiazine-4a(3H)-carboxylate]

and its R-enantimomer [(R)-methyl 7-

chloro-2,5-dihydro-2-

[[(methoxycarbonyl)[4-

(trifluoromethoxy)phenyl]amino]

carbonyl]indeno[1,2-e][1,3,4]oxadiazine4a(3H)-carboxylate] in or on the

following raw agricultural commodities:

Commodity Parts per

million

Apple ......................................... 1.0

Apple, wet pomace ................... 3.0

Brassica, head and stem, subgroup ..................................... 5.0

Cattle, goat, horse, sheep and

hog fat ................................... 0.75

Cattle, goat, horse, sheep and

hog meat ............................... 0.03

Cattle, goat, horse, sheep and

hog meat byproducts ............ 0.02

Corn, sweet, forage .................. 10

Corn, sweet, kernel plus cob

with husk removed ................ 0.02

Corn, sweet, stover .................. 15

Cotton gin byproducts .............. 15

Cotton, undelinted seed ........... 2.0

Lettuce, head ............................ 4.0

Lettuce, leaf .............................. 10

Milk ........................................... 0.10

Milk fat ...................................... 3.0

Pear .......................................... 0.20

Vegetables, fruiting, group ....... 0.50

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 00–25052 Filed 9–28–00; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301058; FRL–6746–2]

RIN 2070–AB78

Halosulfuron–methyl; Pesticide

Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

tolerance for residues of halosulfuron–

methyl in or on the squash/cucumber

subgroup. The Interregional Research

Project 4 (IR–4) requested this tolerance

under the Federal Food, Drug, and

Cosmetic Act, as amended by the Food

Quality Protection Act of 1996.

DATES: This regulation is effective

September 29, 2000. Objections and

requests for hearings,identified by

docket control number OPP–301058,

must be received by EPA on or before

November 28, 2000.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, in person, or by courier. Please

follow the detailed instructions for each

method as provided in Unit VI. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301058 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT By

mail: Sidney Jackson, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave.,

NW.,Washington, DC 20460; telephone

number: (703) 305–7610; and e-mail

address: jackson.sidney@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer, or pesticide

manufacturer. Potentially affected

categories and entities may include, but

are not limited to:

Categories NAICS codes

Examples of potentially affected

entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing