65 FR 190 pgs. 58415-58424 - Indoxacarb; Pesticide Tolerance
Type: RULEVolume: 65Number: 190Pages: 58415 - 58424
Docket number: [OPP-301064; FRL-6747-8]
FR document: [FR Doc. 00-25052 Filed 9-28-00; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
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 thecombined 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 FederalFood, 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 . Toensure proper receipt by EPA, your objections and hearing requests must identify docket controlnumber 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.jane-scott@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, foodmanufacturer, or pesticide manufacturer. Potentially affected categories and entities mayinclude, 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 readersregarding entities likely to be affected by this action. Other types of entities not listed in thetable 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 actionmight apply to certain entities. If you have questions regarding the applicability of this action toa particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .
B. How Can I Get Additional Information, Including Copies of this Document and OtherRelated Documents?
1. Electronically .You may obtain electronic copies of this document,and certain other related documents that might be available electronically, from the EPA InternetHome 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 " FederalRegister -Environmental Documents." You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/. To access the OPPTSHarmonized Guidelines referenced in this document, go directly to the guidelines athttp://www.epa.gov/opptsfrs/home/guidelin.htm.
2. In person . The Agency has established an official record for thisaction under docket control number OPP-301064. The official record consists of thedocuments specifically referenced in this action, and other information related to this action,including any information claimed as Confidential Business Information (CBI). This officialrecord includes the documents that are physically located in the docket, as well as the documentsthat are referenced in those documents. The public version of the official record does not includeany information claimed as CBI. The public version of the official record, which includesprinted, paper versions of any electronic comments submitted during an applicable commentperiod 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 FR18912-18919) (FRL-5782-8), EPA issued a notice pursuant to section 408of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the FoodQuality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the filing of apesticide 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 petitionprepared by DuPont, the registrant. There were three comments in response to the Notice ofFiling from members of the cotton industry. They expressed concern for the use of terminologyassociated with cotton in the Notice of Filing. These cotton terminology comments wereforwarded within the Agency to the evaluators of the cotton portion of the submission whichultimately did not impact the interpretation of the submission.
The petition (8F4948) requested that 40 CFR 180.564 be amendedby establishing permanent tolerances for residues of the insecticide DPX-MP062 (75:25enantiomeric mixture of indoxacarb and its R-enantiomer), [R,S)-methyl7-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 asfollows: pome fruit at 2.0 parts per million (ppm), apple pomace at 6.0 ppm, Brassicas , head and stemat 10.0 ppm, cottonseed at 3.0 ppm, cotton gin trash at 15.0 ppm, leaf lettuce at 20.0ppm, 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 0.10ppm, cattle kidney at 0.05 ppm; and by establishing a tolerance for residues of the insecticideDPX-MP062, (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 and its metabolite (IN-JT333), methyl7-chloro-2,5-dihydro-2-[[[4-(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-e][1,3,4]oxadiazine- 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 legallimit 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 meanthat" there is a reasonable certainty that no harm will result from aggregate exposure tothe pesticide chemical residue, including all anticipated dietary exposures and all other exposuresfor which there is reliable information." This includes exposure through drinking waterand 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 pesticidechemical residue in establishing a tolerance and to " ensure that there is a reasonablecertainty that no harm will result to infants and children from aggregate exposure to the pesticidechemical residue.."
EPA performs a number of analyses to determine the risks from aggregate exposureto pesticide residues. For further discussion of the regulatory requirements of section 408 and acomplete description of the risk assessment process, see the final rule on Bifenthrin PesticideTolerances (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 dataand other relevant information in support of this action. EPA has sufficient data to assess thehazards 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 0.03ppm; cattle, goat, horse, sheep and hog meat byproducts at 0.02 ppm; corn, sweet, forage at 10ppm; corn, sweet, kernel plus cob with husk removed at 0.02 ppm; corn, sweet, stover at 15ppm; cotton gin byproducts at 15 ppm; cotton, undelinted seed at 2.0 ppm; lettuce, head at 4.0ppm; 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 associatedwith 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 twoenantiomers: indoxacarb which is insecticidally active, and its R-enantiomer, which is insecticidally inactive. DPX-JW062 is a mixture of these same two enantiomers; however, theyare 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).
| 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/dayLOAEL = M 6.0 mg/kg/day, F 3.8 mg/kg/day based on decreasedbody weight, body weight gain, food consumption and foodefficiency. |
| 870.3100 | 90-Day oraltoxicityrodents-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 basedon mortality (F only), decreased. body weight, body weight gain,food consumption and food efficiency in rats. |
| 870.3100 | 90-Day oraltoxicityrodents- rats | DPX-JW062 / NOAEL = M 3.7, F 4.9 mg/kg/dayLOAEL = M 7.5, F 12 mg/kg/day based on decreased in absolutebody weight, body weight gain and food efficiency in rats. |
| 870.3100 | 90-Day oraltoxicityrodents- mice | DPX-JW062 / NOAEL = M23, F 16 mg/kg/dayLOAEL = M 44, F 30 mg/kg/day based on mortality (M only);increased reticulocytes and Heinz bodies and decreased bodyweight, weight gain, food consumption, food efficiency; andincreased clinical signs (leaning to one side and/or with abnormalgait or mobility) (F only) in mice. |
| 870.3150 | 90-Day oral toxicity innonrodents-dogs | DPX-JW062 / NOAEL = 5.0 mg/kg/dayLOAEL = 19 mg/kg/day based on hemolytic anemia, as indicated bydecreased in HGB, RBCs; increases in platelets, increasedreticulocytes; and secondary histopathologic findings indicative ofblood breakdown (pigment in Kupffer cells, renal tubularepithelium, and spleen and bone marrow macrophages); increased insplenic EMH; and RBC hyperplasia in bone marrow in dogs. |
| 870.3200 | 28-Day dermal toxicity- rats | DPX-MP062 /NOAEL = 2,000 mg/kg/dayLOAEL = 2,000 mg/kg/day in rats. |
| 870.3200 | 28-Day dermal toxicity- rats | DPX-MP062 / NOAEL = 50 mg/kg/dayLOAEL = 500 mg/kg/day based on decreased body weights, bodyweight gains, food consumption, and food efficiency in F, andchanges in hematology parameters (increased reticulocytes), thespleen (increased absolute and relative weight M only, grossdiscoloration), clinical signs of toxicity in both sexes in rats. |
| 870.3700a | Prenatal developmentalin rodents-rats | DPX-MP062 /Maternal NOAEL = 2.0 mg/kg/day, LOAEL = 4.0 mg/kg/daybased on decreased mean body weights, body weight gains, foodconsumption.Developmental NOAEL = 2.0 mg/kg/day, LOAEL = 4.0 mg/kg/daybased on decreased fetal weights. |
| 870.3700a | Prenatal developmentalin rodents-rats | DPX-JW062 /Maternal NOAEL = 10 mg/kg/day, LOAEL = 100 mg/kg/daybased on mortality, clinical signs, and decreased mean bodyweights, body weight gains, and food consumption.Developmental NOAEL = 10 mg/kg/day, LOAEL = 100 mg/kg/daybased on decreased numbers of live fetuses/litter. |
| 870.3700a | Prenatal developmentalin rodents-rats | DPX-JW062 /Maternal NOAEL = 1.1 mg/kg/dayLOAEL = 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/dayLOAEL = 2.2 mg/kg/day based on decreased fetal body weights. |
| 870.3700b | Prenatal developmentalin nonrodents-rabbits | DPX-JW062 /Maternal NOAEL = 500 mg/kg/dayLOAEL = 1,000 mg/kg/day based on slight decreases in maternalbody weight gain and food consumption.Developmental NOAEL = 500 mg/kg/dayLOAEL = 1,000 mg/kg/day based on decr. fetal body weights andreduced ossification of the sternebrae. |
| 870.3800 | Reproduction andfertility effects-rats | DPX-JW062 /Parental/Systemic NOAEL = 1.5 mg/kg/dayLOAEL = 4.4 mg/kg/ day based on decreased. body weights, bodyweight gains, and food consumption of F 0 females, and increasedspleen weights in the F 0 and F 1 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/daybased on decreased in the body weights of the F 1 pups duringlactation. |
| 870.4100a | Chronic toxicityrodents-rats | DPX-JW062 / NOAEL = M 5, F 2.1 mg/kg/day, LOAEL = M 10, F3.6 mg/kg/day based on decreased body weight, body weight gain,and food consumption and food efficiency; decreased HCT, HGBand RBC at 6 months in F only. no evidence of carcinogenicpotential |
| 870.4100b | Chronic toxicity-dogs | DPX-JW062 / NOAEL = M 2.3, F 2.4 mg/kg/dayLOAEL = M 18, F 19 mg/kg/day based on decreased. HCT, HGBand RBC; increased Heinz bodies and reticulocytes and associatedsecondary microscopic changes in the liver, kidneys, spleen, andbone marrow; increased absolute and relative liver weights. |
| 870.4200 | Carcinogenicity-rats | DPX-JW062 / see 870.4100ano 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 formutagenic activity both with and without S9 activation for theconcentration 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 theconcentration range 10-5000 µg/plate. |
| 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 followingconcentration ranges: Negative;100-1,000 µg/mL (-S9); 100-1,000µg/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 concentrationranges: 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 concentrationranges: 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 neurotoxicityscreening battery - rat | DPX-MP062 / NOAEL = M 100, F 12.5 mg/kgLOAEL = M 200 mg/kg based on decreased body weight gain,decreased food consumption, decreased forelimb grip strength, anddecreased foot splay. F 50 mg/kg based on decreased body weight,body weight gain, and food consumption |
| 870.6200a | Acute neurotoxicityscreening battery -rats | DPX-JW062 / NOAEL = M 2,000 mg/kg, F 500 mg/kgLOAEL M 2,000 mg/kg, F 500 mg/kg based on clinical signs,decreased body weight gains and food consumption, and FOBeffects |
| 870.6200b | Subchronicneurotoxicity screeningbattery - rats | DPX-MP062 / NOAEL = M 0.57, F 0.68 mg/kg/dayLOAEL = M 5.6, F 3.3 mg/kg/day based on decreased body weightand alopecia. |
| 870.7485 | Metabolism andpharmacokinetic - rats | Both DPX-MP062 and DPX-JW062 were extensively metabolizedand the metabolites were eliminated in urine, feces, and bile. Themetabolite profile for DPX-JW062 was dose dependent and variedquantitatively between males and females. Differences in metaboliteprofiles were also observed for the different label positions(indanone and trifluoromethoxyphenyl rings). All biliarymetabolites undergo further biotransformation in the gut. Theproposed metabolic pathway for both DPX-MP062 and DPX-JW062 has multiple metabolites bearing one of the two ringstructures. |
B. Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL) from the toxicologystudy identified as appropriate for use in risk assessment is used to estimate the toxicologicallevel of concern (LOC). However, the lowest dose at which adverse effects of concern areidentified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in thetoxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherentin the extrapolation from laboratory animal data to humans and in the variations in sensitivityamong members of the human population as well as other unknowns. An UF of 100 is routinelyused, 10X to account for interspecies differences and 10X for intraspecies differences.
For dietary risk assessment (other than cancer) the Agency uses the UF to calculatean acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to theNOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factoris retained due to concerns unique to the FQPA, this additional factor is applied to the RfD bydividing the RfD by such additional factor. The acute or chronic 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 theLOC. For example, when 100 is the appropriate UF (10X to account for interspecies differencesand 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL toexposures (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 theAgency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposurewill lead to some degree of cancer risk. A Q* is calculated and used to estimate risk whichrepresents a probability of occurrence of additional cancer cases (e.g., risk is expressed as1 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 notexpected. The point of departure is typically a NOAEL based on an endpoint related to cancereffects 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 (MOE cancer = 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:
| Exposure Scenario | Dose Used in Risk Assessment, Uncertainty Factor (UF) | FQPA Safety Factor (SF) * and Endpoint for Risk Assessment | Study and Toxicological Effects |
|---|---|---|---|
| Acute dietaryfemales 13-50 years of age | NOAEL = 2.0 mg/kg/dayUF = 100Acute RfD = 0.02 mg/kg | FQPA SF = 1aPAD = acute RfD ÷ FQPA SF= 0.02 mg/kg/day | Developmental rat toxicity study.developmental LOAEL = 4.0mg/kg/day based on decreasedfetal body weight. |
| Acute dietarygeneral population including infants andchildren | NOAEL= 12.5mg/kgUF = 100Acute RfD =0.12 mg/kg | FQPA SF = 1aPAD = acute RfD ÷ FQPA SF= 0.12 mg/kg/day | Acute oral rat neurotoxicity study.LOAEL = 50 mg/kg based ondecreased body weight and bodyweight gain in females. |
| Chronic dietary all populations | NOAEL= 2.0 mg/kg/dayUF = 100Chronic RfD =0.02 mg/kg/day | FQPA SF = 1cPAD = chr RfD ÷FQPA SF= 0.02 mg/kg/day | 90-Day rat subchronic toxicitystudy, 90-day rat neurotoxicity study,chronic/carcinogenicity rat study.LOAEL = 3.3 mg/kg/day based ondecreased body weight, alopecia,body weight gain, foodconsumption and food efficiency;decreased hematocrit, hemoglobinand red blood cells only at 6months. 3.3 mg/kg/day is thelowest NOAEL/LOAEL of the3 studies. |
| Short-termoral (1-7 days)(Residential) | Oral studyNOAEL= 2.0mg/kg/day | LOC for MOE =100 (Residential,includes the FQPASF) | Developmental rat toxicity study.maternal LOAEL = 4.0 mg/kg/daybased on decreased mean maternalbody weights, body weight gains,and food consumption. |
| Intermediate-term oral (1week - severalmonths)(Residential) | Oral studyNOAEL= 2.0mg/kg/day | LOC for MOE =100 (Residential,includes the FQPASF) | 90-day rat subchronic toxicitystudy.LOAEL = 3.8 mg/kg/day based ondecreased body weight, bodyweight gain, food consumptionand food efficiency. |
| Short- (1-7days), intermediate- (1 week-severalmonths), andlong- (severalmonths-lifetime) termdermal(Occupational/Residential) | Dermal studyNOAEL= 50mg/kg/day | LOC for MOE =100 (Occupational)LOC for MOE =100 (Residential,includes the FQPASF) | 28-day rat dermal toxicity study.LOAEL = 500 mg/kg/day basedon decreased body weights, bodyweight gains, food consumption,and food efficiency in females,and changes in hematologyparameters (increasedreticulocytes), the spleen(increased absolute and relativeweight males only, grossdiscoloration), and clinical signsof toxicity in both sexes. |
| Short-terminhalation (1-7days)(Occupational/Residential) | Oral studyNOAEL= 2.0mg/kg/day(inhalationabsorption rate =100%) | LOC for MOE =100 (Occupational)LOC for MOE =100 (Residential,includes the FQPASF) | Rat developmental toxicity study.maternal LOAEL = 4.0 mg/kg/daybased on decreased mean maternalbody weights, body weight gains,and food consumption. |
| Intermediate-terminhalation (1week-severalmonths)(Occupational/Residential) | Oral studyNOAEL= 2.0mg/kg/day(inhalationabsorption rate =100%) | LOC for MOE =100 (Occupational)LOC for MOE =100 (Residential,includes the FQPASF) | 90-day rat subchronic toxicitystudy.LOAEL = 3.8 mg/kg/day based ondecreased body weight, bodyweight gain, food consumptionand food efficiency. |
| Long-terminhalation(severalmonths-lifetime)(Occupational/Residential) | Oral studyNOAEL= 2.0mg/kg/day(inhalationabsorption rate=100%) | LOC for MOE =100 (Occupational)LOC for MOE =100 (Residential,includes the FQPASF) | 90-day rat subchronic toxicitystudy,90-day rat neurotoxicity study,chronic/carcinogenicity rat study.LOAEL = 3.3 mg/kg/day based ondecreased body weight, bodyweight gain, food consumptionand food efficiency; decreasedhematocrit, hemoglobin and redblood cells only at 6 months. |
| Cancer (oral,dermal, inhalation) | "not likely" tobe carcinogenic to humans | N/A | No evidence of carcinogenicity ineither the rat or mouse inacceptable carcinogenicity studiesand 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 beenestablished (40 CFR 180.564) for the combined residues or residues ofindoxacarb and its R-enantiomer, in or on a variety of raw agricultural commodities includingapples, pears, Brassica (head and stem subgroup), cotton, leaf lettuce, head lettuce, fruitingvegetable 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 fromindoxacarb and its R-enantiomer in food as follows:
i. Acute exposure . Acute dietary risk assessments are performed for afood-use pesticide if a toxicological study has indicated the possibility of an effect of concernoccurring as a result of a one day or single exposure. The Dietary Exposure Evaluation Model (DEEM) analysis evaluated the individual food consumption as reported byrespondents in the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. Thefollowing assumptions were made for the acute exposure assessments: acute Tier 1 analysisassuming 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 exposureassessments: 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 treatedInformation .Section 408(b)(2)(E) authorizes EPA to use available data and information on theanticipated residue levels of pesticide residues in food and the actual levels of pesticidechemicals that have been measured in food. If EPA relies on such information, EPA must requirethat 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 initialdata 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 call-in for information relating toanticipated residues to be submitted no later than 5 years from the date of issuance of thistolerance.
2. Dietary exposure from drinking water .The Agency lacks sufficient monitoring exposure data to complete a comprehensivedietary exposure analysis and risk assessment for indoxacarb and its R-enantiomer in drinkingwater. Because the Agency does not have comprehensive monitoring data, drinking waterconcentration estimates are made by reliance on simulation or modeling taking into account dataon the physical characteristics of indoxacarb and its R-enantiomer.
The Agency uses the Generic Estimated Environmental Concentration (GENEEC) orthe Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) to estimatepesticide concentrations in surface water and the Screening Concentration in Ground Water Model (SCI-GROW), which predicts pesticideconcentrations in ground water. In general, EPA will use GENEEC (a Tier 1 model) beforeusing PRZM/EXAMS (a Tier 2 model) for a screening-level assessment for surface water. TheGENEEC model is a subset of the PRZM/EXAMS model that uses a specific high-end runoffscenario for pesticides. GENEEC incorporates a farm pond scenario, while PRZM/EXAMSincorporate an index reservoir environment in place of the previous pond scenario. ThePRZM/EXAMS model includes a percent crop area factor as an adjustment to account for themaximum 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 theremoval of pesticides from the source water. The primary use of these models by the Agency atthis stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikelythat drinking water concentrations would ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the risk assessmentprocess, the Agency does not use estimated environmental concentrations (EECs) from thesemodels to quantify drinking water exposure and risk as a %RfD or %PAD. Instead drinkingwater levels of comparison (DWLOCs) are calculated and used as a point of comparison againstthe model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limitson a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticidein food, and from residential uses. Since DWLOCs address total aggregate exposure toindoxacarb 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 environmentalconcentrations (EECs) of indoxacarb and its R-enantiomer for acute exposures are estimated tobe 3.81 parts per billion (ppb) for surface water and 0.02 ppb for ground water. The EECs forchronic 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 "residentialexposure" 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 controlon pets). Indoxacarb and its R-enantiomer is not registered for use on any sites that would resultin residential exposure.
4. Cumulative exposure to substances with a common mechanism oftoxicity . 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 "othersubstances that have a common mechanism of toxicity."
EPA does not have, at this time, available data to determine whether indoxacarb andits R-enantiomer has a common mechanism of toxicity with other substances or how to includethis pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA hasfollowed a cumulative risk approach based on a common mechanism of toxicity, indoxacarb andits 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 itsR-enantiomer has a common mechanism of toxicity with other substances. For informationregarding EPA's efforts to determine which chemicals have a common mechanism of toxicityand to evaluate the cumulative effects of such chemicals, see the final rule for BifenthrinPesticide Tolerances (62 FR 62961, November 26, 1997).
D. Safety Factor for Infants and Children
1. Safety factor for infants and children -i. Ingeneral . FFDCA section 408 provides that EPA shall apply an additional tenfold margin ofsafety for infants and children in the case of threshold effects to account for prenatal andpostnatal toxicity and the completeness of the data base on toxicity and exposure unless EPAdetermines that a different margin of safety will be safe for infants and children. Margins ofsafety are incorporated into EPA risk assessments either directly through use of a margin ofexposure (MOE) analysis or through using uncertainty (safety) factors in calculating a dose levelthat poses no appreciable risk to humans.
ii. Prenatal and postnatal sensitivity . There is no evidence ofsusceptibility 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 forindoxacarb and its R-enantiomer and exposure data are complete or are estimated based on datathat reasonably accounts for potential exposures. The FQPA safety factor is 1X. EPAdetermined 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 isnot based on the criteria reflecting special concern for the developing fetuses or young which aregenerally 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 inoffspring; 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 thepotential exposures for infants and children; and there are no registered residential uses at thecurrent time.
E. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food, drinking water, andresidential uses, the Agency calculates DWLOCs which are used as a point of comparisonagainst the model estimates of a pesticide's concentration in water (EECs). DWLOC values arenot regulatory standards for drinking water. DWLOCs are theoretical upper limits on apesticide's concentration in drinking water in light of total aggregate exposure to a pesticide infood and residential uses. In calculating a DWLOC, the Agency determines how much of theacceptable 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 Officeof Water are used to calculate DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and1L/10 kg (child). Default body weights and drinking water consumption values vary on anindividual basis. This variation will be taken into account in more refined screening-level andquantitative drinking water exposure assessments. Different populations will have differentDWLOCs. 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 calculatedDWLOCs, OPP concludes with reasonable certainty that exposures to the pesticide in drinkingwater (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 OPPconsiders the aggregate risk resulting from multiple exposure pathways associated with apesticide's uses, levels of comparison in drinking water may vary as those uses change. If newuses are added in the future, OPP will reassess the potential impacts of residues of the pesticidein 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 aPADfor 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 indoxacarband 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:
| Scenario / PopulationSubgroup | aPAD (mg/kg/day) | % aPAD | Surface WaterEEC (ppb) | GroundWater EEC(ppb) | AcuteDWLOC(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 thisunit for chronic exposure, EPA has concluded that exposure to indoxacarb and its R-enantiomerfrom food will utilize 28% of the cPAD for the U.S. population, 37% of the cPAD for infants 1year old, and 73% of the cPAD for children 1-6 years old. There are no residential uses forindoxacarb and its R-enantiomer that result in chronic residential exposure to indoxacarb and itsR-enantiomer. In addition, there is potential for chronic dietary exposure to indoxacarb and itsR-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:
| 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 wouldresult in residential exposure. Therefore, the aggregate risk is the sum of the risk from food andwater do not exceed the Agency's level of concern.
4. Intermediate-term risk . Intermediate-term aggregate exposure takesinto account residential exposure plus chronic exposure to food and water (considered to be abackground exposure level). Indoxacarb and its R-enantiomer is not registered for use onany sites that would result in residential exposure. Therefore, the aggregate risk is the sum of therisk from food and water, which do not exceed the Agency's level of concern.
5. Determination of safety . Based on these risk assessments, EPAconcludes 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 thetolerance expression. The method may be requested from: Calvin Furlow, PRRIB, IRSD(7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 PennsylvaniaAve., 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)-methyl7-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 agriculturalcommodities: at 1.0 ppm; apple, wet pomace at 3.0 ppm; Brassica , head and stem, subgroup at5.0 ppm; cattle, goat, horse, sheep and hog fat at 0.75 ppm; cattle, goat, horse, sheep and hogmeat 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 0.20ppm; 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 filean 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 forhearings appear in 40 CFR part 178. Although the procedures in those regulations require somemodification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA willcontinue to use those procedures, with appropriate adjustments, until the necessary modificationscan 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 toleranceissued by EPA under new section 408(d), as was provided in the old FFDCA sections 408 and409. 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 accordancewith the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt byEPA, you must identify docket control number OPP-301064 in the subject line on thefirst page of your submission. All requests must be in writing, and must be mailed or deliveredto the Hearing Clerk on or before November 28, 2000.
1. Filing the request . Your objection must specify the specificprovisions in the regulation that you object to, and the grounds for the objections (40 CFR178.25). 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 ofany evidence relied upon by the objector (40 CFR 178.27). Information submitted in connectionwith an objection or hearing request may be claimed confidential by marking any part or all ofthat information as CBI. Information so marked will not be disclosed except in accordance withprocedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI mustbe submitted for inclusion in the public record. Information not marked confidential may bedisclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900), EnvironmentalProtection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may alsodeliver 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 theHearing Clerk is (202) 260-4865.
2. Tolerance fee payment . If you file an objection or request ahearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that feepursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters AccountingOperations 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: opp-docket@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 anyCBI 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 thematerial submitted shows the following: There is a genuine and substantial issue of fact; there isa reasonable possibility that available evidence identified by the requestor would, if establishedresolve one or more of such issues in favor of the requestor, taking into account uncontestedclaims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by therequestor 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 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 thatthis 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 theStates, 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. Thisaction 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 theUnited 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 finalrule 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]oxadiazine-4a(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