51604 Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 

Dated: August 19, 2005. 

Lois Rossi, 

Director, Registration Division, 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. In § 180.554, the table in paragraph 

(b) is amended by alphabetically adding 

commodities to read as follows: 

§ 180.544 Methoxyfenozide; tolerance for 

residues. 

* * * * * 

(b) *** 

Commodity Parts per million Expiration/revocation date 

sorghum, grain 0.05 12/31/2007 

sorghum, grain, forage 15 12/31/2007 

sorghum, grain, stover 125 12/31/2007 

* * * * * 

[FR Doc. 05–17131 Filed 8–30–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[OPP–2005–0217; FRL–7731–6] 

Flonicamid; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for combined residues of 

flonicamid and its metabolites in or on 

certain plant and livestock 

commodities. ISK Biosciences requested 

this tolerance under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), as 

amended by the Food Quality Protection 

Act of 1996 (FQPA). 

DATES: This regulation is effective 

August 31, 2005. Objections and 

requests for hearings must be received 

on or before October 31, 2005. 

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VI. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2005–

0217. All documents in the docket are 

listed in the EDOCKET index athttp:// 

www.epa.gov/edocket. Although listed 

in the index, some information is not 

publicly available, i.e., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available either 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 S. Bell St., 

Arlington, VA. This docket facility is 

open from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The docket telephone number 

is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: Ann 

Sibold, Registration Division (7505C), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6502; e-mail 

address:sibold.ann@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does This Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS 111), e.g., 

agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS 112), 

e.g., cattle ranchers and farmers, dairy 

cattle farmers, livestock farmers. 

• Food manufacturing (NAICS 311), 

e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

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 this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed underFOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document and Other Related 

Information? 

In addition to using EDOCKET (http:// 

www.epa.gov/edocket/), you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr/. A 

frequently updated electronic version of 

40 CFR part 180 is available at E-CFR 

Beta Site Two at http:// 

www.gpoaccess.gov/ecfr/. To access the 

OPPTS Harmonized Guidelines 

referenced in this document, go directly 

to the guidelines athttp://www.epa.gpo/ 

opptsfrs/home/guidelin.htm/. 

II. Background and Statutory Findings 

In the Federal Register of May 23, 

2003 (68 FR 28218) (FRL–7307–5), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 3F6552) by ISK 

Biosciences, 7470 Auburn Road, suite 

A, Concord, Ohio 44077. The petition 

requested that 40 CFR part 180 be 

amended by establishing a tolerance for 

the combined residues of the insecticide 

flonicamid, [N-(cyanomethyl)-4- 

trifluoromethylnicotinamide] and its 

metabolites, TFNA, (4- 

trifluoromethylnicotinic acid), TFNAAM, (4-trifluoromethylnicotinamide) 

and TFNG, [N-(4- 

trifluoromethylnicotinoyl)glycine] in or 

on the raw agricultural commodities: 

Celery, at 1.2 parts per million (ppm); 

cotton, at 0.5 ppm; cotton, gin trash, at 

6.0 ppm; cotton, hulls, at 1.0 ppm; 

cotton, meal, at 1.0 ppm; fruit, pome, 

group 11, at 0.2 ppm; fruit, stone, group 

12, except plum and fresh prune plum, 

at 0.7 ppm; lettuce, head, at 1.0 ppm; 

lettuce, leaf, at 4.0 ppm; plum, at 0.1 

ppm; potato, at 0.2 ppm; potato, flakes, 

at 0.4 ppm; prune, fresh, at 0.1; spinach, 

at 9.0 ppm; tomato, paste, at 2.0 ppm; 

tomato, puree, at 0.5 ppm; vegetable, 

Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 51605 

cucurbit, group 9, at 0.4 ppm; vegetable, 

fruiting, group 8, at 0.4 ppm; by 

establishing tolerances for the combined 

residues of the insecticide flonicamid, 

[N-(cyanomethyl)-4- 

trifluoromethylnicotinamide] and its 

metabolite TFNA-AM, (4- 

trifluoromethylnicotinamide) in animal 

tissues and poultry meat 

byproducts:Cattle, fat, at 0.01 ppm; 

cattle, meat, at 0.04 ppm; eggs, at 0.02 

ppm; goat, fat, at 0.01 ppm; goat, meat, 

at 0.04 ppm; hog, fat, at 0.01; hog, meat, 

at 0.01 ppm; horse, fat, at 0.01 ppm; 

horse, meat, at 0.04 ppm; milk, at 0.02 

ppm; poultry, fat, at 0.01 ppm; poultry, 

meat, at 0.01 ppm; poultry, meat 

byproducts, at 0.01 ppm; sheep, fat, at 

0.01 ppm; sheep, meat, at 0.04 ppm; by 

establishing tolerances for the combined 

residues of the insecticide flonicamid 

[N-(cyanomethyl)-4- 

trifluoromethylnicotinamide] and its 

metabolites TFNA, (4- 

trifluoromethylnicotinic acid) and 

TFNA-AM, (4- 

trifluoromethylnicotinamide) in the 

animal meat byproducts: cattle, meat 

byproducts, at 0.06 ppm; goat, meat 

byproducts, at 0.06 ppm; hog, meat 

byproducts, at 0.01 ppm; horse, meat 

byproducts, at 0.06 ppm; and sheep, 

meat byproducts, at 0.06 ppm. That 

notice included a summary of the 

petition prepared by ISK Biosciences, 

the registrant. One comment was 

received on the notice of filing. EPA’s 

response to this comment is discussed 

in Unit IV.C. 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’

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 of FFDCA 

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) 

of FFDCA, 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) of 

FFDCA, for a tolerance for combined 

residues of flonicamid and its 

metabolites on various crop and 

livestock commodities at levels set forth 

in the list below. 

Tolerances for combined residues of 

flonicamid and its metabolites in/on 

crops and livestock commodities. 

1. Recommended tolerances for 

combined residues of flonicamid and its 

metabolites TFNA, TFNG and TFNAAM in/on crops. 

Cotton, undelinted seed at 0.50 ppm 

Cotton, gin byproducts at 6.0 ppm 

Cotton, hulls at 2.0 ppm 

Cotton, meal at 1.0 ppm 

Fruit, pome, group 11 at 0.20 ppm 

Fruit, stone, group at 12 0.60 ppm 

Potato 0.20 at ppm 

Potato, granular/flakes at 0.40 ppm 

Spinach at 9.0 ppm 

Tomato, paste at 2.0 ppm 

Tomato, puree at 0.50 ppm 

Vegetable, cucurbit, group at 0.40 

ppm 

Vegetable, fruiting, group at 0.40 ppm 

Vegetable, leafy except Brassica group 

4, except spinach at 4.0 ppm 

2. Recommended tolerances for 

combined residues of flonicamid and its 

metabolites TFNA and TFNA-AM in/on 

livestock commodities. 

Cattle, fat at 0.02 ppm 

Cattle, meat at 0.05 ppm 

Egg at 0.03 ppm 

Goat, fat at 0.02 ppm 

Goat, meat at 0.05 ppm 

Horse, fat at 0.02 ppm 

Horse, meat at 0.05 ppm 

Milk at 0.02 ppm 

Poultry, fat at 0.02 ppm 

Poultry, meat at 0.02 ppm 

Poultry, meat byproducts at 0.02 ppm 

Sheep, fat at 0.02 ppm 

Sheep, meat at 0.05 ppm 

Cattle, meat byproducts at 0.08 ppm 

Goat, meat byproducts at 0.08 ppm 

Horse, meat byproducts at 0.08 ppm 

Sheep, meat byproducts at 0.08 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. Specific 

information on the studies received and 

the nature of the toxic effects caused by 

flonicamid as well as the no observed 

adverse effect level (NOAEL) and the 

lowest observed adverse effect level 

(LOAEL) from the toxicity studies are 

discussed in Table 1 of this unit. 

51606 Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 

TABLE 1.—SUBCHRONIC, CHRONIC AND OTHER TOXICITY OF FLONICAMID

Guideline No. Study Type Dose Levels Results 

870.3100 90–Day oral toxicity rodents (rats) 

28–day range-finding 

0, 50 (males), 200, 

1,000,2,000 (males), 

or 5,000(females) 

ppm (3.08, 

12.11,60.0, or 119.4 

mg/kg/day,males and 

14.52, 72.3, or340.1 

mg/kg/day, females) 

0, 50 (males), 100, 

500, 1,000,5,000 or 

10,000 (females)ppm 

(3.61, 7.47, 

36.45,73.8, or 353.4 

mg/kg/day,males and 

8.36, 41.24, 

81.9,372.6, or 642 

mg/kg/day,females) 

NOAEL is 200 ppm (12.11 mg/kg/day) formales 

and 1,000 ppm (72.3 mg/kg/day) forfemales 

LOAELs were 1,000 ppm (60.0 mg/kg/day) 

formales based on changes in the kidney 

(hyalinedeposition) and 5,000 ppm (340 mg/ 

kg/day) forfemales based on kidney (hyaline 

deposition)and liver changes (centrilobular 

hypertrophy) 

NOAEL is 100 ppm (7.47 mg/kg/day) for 

malesand 1,000 ppm (81.9 mg/kg/day) for females. 

LOAELs were 500 ppm (36.45 mg/kg/day) 

formales based on changes in the kidney 

(hyalinedeposition) and 5,000 ppm for females (372.6mg/kg/day) based on kidney 

(hyalinedeposition), liver changes 

(centrilobularhypertrophy), hematological effects (anemia)and clinical chemistry (increased cholesterol) 

870.3100 90–Day oral toxicity rodents (mice) 0, 100, 1,000 or 7,000 

ppm(0, 15.25, 153.9 

or 1,069mg/kg bw/ 

day in males,and 0, 

20.10, 191.5, or 

1,248mg/kg bw/day 

in females) 

NOAEL is 100 ppm (males: 15.25 mg/kgbw/ 

day, females: 20.10 mg/kg bw/day) 

LOAEL is 1,000 ppm in (males: 153.9 mg/ 

kgbw/day; females: 191.5 mg/kg bw/day) 

basedon extramedullary hematopoiesis of 

the spleen 

Many of the tissues/organs recommended 

byGuideline 870.3100 were not 

histologicallyexamined in any dose group, 

but this study isnot required and serves as a 

range-findingstudy for the mouse carcinogenicity study.Therefore, it is classified as 

acceptable, non-guideline study 

870.3150 90–Day oral toxicity 

(nonrodents- dogs) 

0, 3, 8, 20, or 50 (females) mg/kg bw/day NOAEL is 8 mg/kg/day in males and 20 mg/kg/ 

day for female 

LOAEL is 20 mg/kg/day in males and 50 mg/ 

kg/day in females, based on acute clinical 

signs in males and females (vomiting, first 

observed on Day 1 and last observed on 

Day 90), clinical pathology at 7 weeks (increased total protein levels in males, lower 

red blood cells and higher 

reticulocytescounts in females), increased 

adrenal weights in males, decreased 

thymusgland weights in males, and increased kidney tubular vacuolation infemales 

at study termination 

870.3200 28–Day dermal toxicity 

(rats) 

0, 20, 150, or 1,000 

mg/kg/day 

NOAEL is 1,000 mg/kg/day 

LOAEL is >1,000 mg/kg/day 

870.3700 Prenatal developmental 

toxicity (rats) 

0, 20, 100 or 500 mg/ 

kg bw/day 

Maternal 

NOAEL is 100 mg/kg bw/day 

LOAEL is 500 mg/kg bw/day, based 

onincreased liver weight, and liver and 

kidneypathological changes (hypertrophy 

ofcentrilobular hepatocytes in liver 

andvacuolation of proximal tubular cell 

inkidneys) 

Developmental 

NOAEL is 100 mg/kg bw/day 

LOAEL is 500 mg/kg bw/day, based on the increased incidence of cervical rib 

Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 51607 

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

Guideline No. Study Type Dose Levels Results 

870.3700 Prenatal 

developmentaltoxicity 

(rabbits) 

0, 2.5, 7.5, or 25 mg/ 

kg/day 

Maternal 

NOAEL is 7.5 mg/kg/day 

LOAEL is 25 mg/kg, based on decreased 

bodyweights, body weight gains, and food 

consumption 

Developmental 

NOAEL is ≥ 25 mg/kg/day 

LOAEL is not established 

870.3800 Reproduction and fertility effects (rats) 0, 50, 300, or 1,800 

ppm(0/0, 3.7/4.4, 

22.3/26.5, and132.9/ 

153.4 mg/kg bw/day 

[M/F] 

Parental 

NOAEL is 50 ppm (equivalent to 3.7/4.4mg/kg/ 

day [M/F] 

LOAEL is 300 ppm (equivalent to 22.3/26.5mg/ 

kg/day [M/F] based on increased 

relativekidney weight and hyaline droplet 

depositionin the proximal tubules of the kidneys in themales and increased blood serum 

LH levels inthe F1 females 

Offspring 

NOAEL is 300 ppm (equivalent to 22.3/26.5mg/ 

kg/day [M/F]. LOAEL is 1,800 

ppm(equivalent to 132.9/153.4 mg/kg/day [M/ 

F]based on decreased absolute and relative 

tobody uterus weights and delayed 

sexualmaturation in the F1 females 

Reproductive Performance 

NOAEL is 1,800 ppm (equivalent to 132.9/ 

153.4mg/kg/day [M/F] 

LOAEL for reproductive performance was 

notobserved 

870.4100 Chronic toxicity (dogs) 0, 3, 8, or 20 mg/kg/ 

day 

NOAEL is 8 mg/kg/day 

LOAEL is 20 mg/kg/day, based on acute clinical signs(vomiting, mostly within the first 

week), clinical pathology at 12 months (higher reticulocytes counts) in males and females 

870.4200 Carcinogenicity (mice) 0, 250, 750, or 2250 

ppm(0/0, 29/38, 88/ 

112, or261/334 mg/ 

kg/day [M/F] 

NOAEL was not established 

LOAEL is 250 ppm (equivalent to 29/38mg/kg/ 

day [M/F]), based on minimal tomoderate 

centrilobular hepatocellularhypertrophy, minimal to severeextramedullary hematopoiesis, 

minimal tomoderate pigment deposition in 

the sternalbone marrow, and increased incidence of tissuemasses/nodules in the lungs 

in the males, andminimal to moderate decreased cellularity inthe femoral bone marrow andhyperplasia/hypertrophy of the 

epithelial cellsof the terminal bronchioles of 

the females 

At the doses tested, the carcinogenic 

potentialof IKI-220 (flonicamid) is positive at 

250 ppmin males and females based on the 

increasedincidence of alveolar/bronchiolar 

adenomas,carcinomas, and 

combinedadenomas/carcinomas. Dosing was 

consideredadequate based on increased incidence of tissuemasses/nodules in the lungs 

and microscopicfindings in the liver, spleen, 

bone marrow, andlungs. However, data were 

providedsuggesting this effect is specific to 

sensitivestrains of mice 

Carcinogenic in mice 

51608 Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 

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

Guideline No. Study Type Dose Levels Results 

870.4200 Carcinogenicity (mice) 0, 10, 25, 80, 250 

ppmmales: 0, 1.20, 

3.14, 10.0,30.3 mg/ 

kg/day; females: 

0,1.42, 3.67, 11.8, 

36.3 mg/kg/day 

NOAEL is 80 ppm (equivalent to 10/12mg/kg/ 

day in males/females) 

LOAEL is 250 ppm (equivalent to 30/36mg/kg/ 

day in males/females) based on lungmasses 

and terminal bronchiole epithelial 

cellhyperplasia/hypertrophy in both sexes 

At the doses tested, the carcinogenic 

potentialof IKI-220 (flonicamid) is positive in 

males andfemales based on the incidences 

ofalveolar/bronchiolar adenomas, carcinomas,and combined adenomas and/or 

carcinomas. Dosing was consideredadequate 

based on lung masses and terminal bronchiole epithelialcell hyperplasia/hypertrophy 

in both sexes 

Carcinogenic in mice 

870.4300 Combined Chronic/carcinogenicity (rats) 0, 50 (males), 100 

(males),200, 1,000, 

or 5,000 (females) 

ppm (0/0, 1.84,3.68, 

7.32/8.92, 36.5/44.1, 

and 219 mg/kg/day 

[M/F] 

NOAEL is 200 ppm (equivalent to 7.32/8.92mg/ 

kg/day in males/females) 

LOAEL is 1,000 ppm (equivalent to 36.5/ 

44.1mg/kg/day in males/females) based 

ondecreased body weights and body weight 

gains,and increased incidences of keratitis in 

malesand striated muscle fiber atrophy in females 

At the high dose there was an incidence 

(12%)of nasolacrimal duct squamous cell 

carcinomasslightly outside the historical control range (0-10%) in male rats. A correlation 

between theincidence of inflammation and 

the fluctuatingincidence of nasal tumors was 

made acrossdose groups. EPA did not consider thenasolacrimal duct tumors to be treatment-related 

Female rats had a significant increasing trendin 

nasolacrimal duct squamous cell 

carcinomasat <0.05, and at the high dose 

was slightlyabove the historical control mean 

(0.8%) andrange (0-4%). EPA considered the 

nasolacrimal duct squamouscell carcinomas 

to be possibly treatment related, but that a 

clearassociation with treatment could not be 

made 

870.5100 Bacterial reverse mutation 61.7 to 5,000 μg/plate 

+/-S9 

Negative 

870.5100 Bacterial system, mammalian 

activationgene mutation 

33 to 5,000 μg/plate +/- 

S9 

Negative for metabolite TFNA 

870.5100 Bacterial system, mammalian 

activationgene mutation 

33 to 5,000 ug/plate +/- 

S9 

Negative for metabolite TFNA-AM 

870.5100 Bacterial system, mammalian 

activationgene mutation 

33 to 5,000 ug/plate +/- 

S9 

Negative for metabolite TFNG-AM 

870.5100 Bacterial system, mammalian 

activationgene mutation 

33 to 5,000 μg/plate +/- 

S9 

Negative for metabolite TFNA-OH 

870.5100 Bacterial system,mammalian activation gene mutation 5 to 5000 ug/plate +/- 

S9 

Negative for metabolite TFNG 

Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 51609 

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

Guideline No. Study Type Dose Levels Results 

870.5300 In vitro mammalian 

cellgene mutation 

28.3 to 2,290 μg/mL 

initialtest, and 143 to 

2,290μg/mL repeat 

Negative 

870.5375 In vitro Cytogenetics 573, 1145 and 2290 

μg/mL 

Negative 

870.5395 In vivo cytogenetic(micronucleus) test 

in mice 

Twice orally by 

intragastricgavage at 

doses of 250, 

500and 1,000 mg/kg/ 

day formales and 

125, 250 and 500mg/ 

kg/day for females 

Negative 

Non-guideline Other genotoxicity, in 

vivo Comet assay 

Single doses of 375, 

750 and 1,500 mg/kg 

Was not positive for nuclear migration up 

to1,500 mg/kg 

Non-guideline Unscheduled DNA synthesis Once orally at 600 and 

2,000 mg/kg 

Is not genotoxic in hepatocytes from treated 

rats 

870.6200 Acute 

neurotoxicityscreening battery (rats) 

0, 100, 300, 600 

(males), or 1,000 mg/ 

kg/day 

NOAEL is 600 mg/kg in males and 300 mg/ 

kgin females 

LOAEL is 1,000 mg/kg based on mortality 

andsigns of toxicity (decreased motor activity,tremors, impaired respiration, and 

impairedgait) in males 

This acute neurotoxicity study is 

unacceptablebecause interval motor activity 

data were notprovided as specified according 

to guidelines,FOB handling and open-field 

observationswere incomplete, and positive 

data providedwere from a lab other than the 

performing labfor this study. This study is not 

required forthis risk assessment and additional informationis not required 

870.6200 Subchronic 

neurotoxicity 

screeningbattery 

(rats) 

0, 200, 1000, or 10,000 

ppm(0/0, 13/16, 67/ 

81, or625/722 mg/kg/ 

day [M/F] 

NOAEL is 200/1,000 ppm (equivalent to 13/ 

81mg/kg/day [M/F] 

LOAEL is 1,000/10,000 ppm (equivalent to67/ 

722 mg/kg/day [M/F] based on 

decreasedmotor activity, rearing, and foot 

splay inmales, decreased body weights, 

body weightgains, and food consumption in 

males andfemales 

870.7485 Metabolism 

andpharmacokinetics 

(rats) 

Pilot excretion study, 

singleoral dose 0.85 

or 21 mg/kgand pilot 

pharmacokineticstudy, single oral dose of 

2or 50 mg/kg 

IKI-220 (flonicamid) was rapidly absorbed 

andexcreted with no apparent differences 

betweenthe sexes. By 48 hours after treatment, 93%of the administered dose had 

been eliminatedand by 168 hours ∼96% was 

eliminated. Theprimary route of elimination 

was the urine,accounting for ∼90% of the 

dose. The feces oftreated rats accounted for 

∼5% of theadministered dose, with no significant amountsof radiolabel detected in expired air of eithersex. After 168 hours of a 

single high or lowdose of the test material, 

<3% of theradioactivity was recovered in the 

carcass and<0.05% in the blood, irrespective 

of dose orsex 

The pharmacokinetic parameters were 

alsosimilar between the dose levels (2 and 

50mg/kg) and sexes. The radiolabel was 

rapidlyabsorbed and excreted. The apparent 

plasmahalf-life (TW) was 4.8-6.0 hours and 

theelimination followed first order kinetics. 

Thetime of maximum plasma concentration(Tmax) for individual animals ranged 

from0.25 to 1 hour after treatment (with a 

mean foreach group of 0.3-0.6 hours) 

51610 Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 

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

Guideline No. Study Type Dose Levels Results 

870.7485 Metabolism and pharmacokinetics (rats) 2 or 400 mg/kg Appears that the overall recovery ofradioactive 

dose from all group was 94-99% by168 

hours post-dose. Absorption was rapidand 

extensive, detected in plasma within 

10minutes of dosing, with maximum 

plasmaconcentrations within 24-54 minutes. 

By 168hours post-dose, total urinary excretion was72-78%, cage rinse was 10-21%, 

and fecalexcretion was 4-7% dose. Parent 

(IKI-220)(flonicamid) and 9 metabolites accounted for80-94% of the dose for all 

groups. Parent wasdetected primarily in the 

urine, 46-73% of thedose in excreta in all 

groups. The primarymetabolite was 4- 

trifluoromethylnicotinamide(TFNA-AM), 18- 

27% dose in all dose groups,along with 

minor amounts of TFNA-AM N-oxide (1-4% 

dose).Other metabolites in urine and feces 

were detected atless than or equal to 2.5% 

of the dose.IKI-220 (flonicamid) was excreted 

primarily unchangedin the urine, but biotransformation of IKI-220(flonicamid) in rats included nitrile hydrolysis,N-oxidation, 

hydroxylation of the pyridine ring and 

amidehydrolysis 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, 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. 

Three other types of safety or 

uncertainty factors may be used: 

‘‘Traditional uncertainty factors;’’ the 

‘‘special FQPA safety factor;’’ and the 

‘‘default FQPA safety factor’’ By the 

term ‘‘traditional uncertainty factor,’’

EPA is referring to those additional 

factors used prior to FQPA passage to 

account for database deficiencies. These 

traditional uncertainty factors have been 

incorporated by the FQPA into the 

additional safety factor for the 

protection of infants and children. The 

term ‘‘Special FQPA safety factor refers 

to those safety factors that are deemed 

necessary for the protection of infants 

and children, primarily as a result of the 

FQPA.’’ The ‘‘default FQPA safety 

factor’’ is the additional 10X safety 

factor that is mandated by the statute 

unless it is decided that there are 

reliable data to choose a different 

additional factor (potentially a 

traditional uncertainty factor or a 

special FQPA safety factor). 

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 an UF of 100 to account for 

interspecies and intraspecies differences 

and any traditional uncertainty factors 

deemed appropriate (RfD = NOAEL/UF). 

Where a special FQPA safety factor or 

the default FQPA safety factor is used, 

this additional safety factor is applied to 

the RfD by dividing 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 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 exposure (margin of 

exposure (MOE) = NOAEL/exposure) is 

calculated and compared to the LOC. 

A summary of the toxicological dose 

and endpoints for flonicamid used for 

human risk assessment is shown in 

Table 2 of this unit: 

TABLE 2.—TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLONICAMID HUMAN HEALTH RISK ASSESSMENTS

Exposure Scenario Dose Used in 

RiskAssessment, UF 

Special FQPA SF* 

andLevel of Concern for 

Risk Assessment 

Study and Toxicological Effects 

Acute dietary None FQPA SF = NA 

aPAD = NA 

Quantitative risk assessment is notrequired 

since there are no acute dietarytoxicity concerns 

Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 51611 

TABLE 2.—TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLONICAMID HUMAN HEALTH RISK ASSESSMENTS—Continued 

Exposure Scenario Dose Used in 

RiskAssessment, UF 

Special FQPA SF* 

andLevel of Concern for 

Risk Assessment 

Study and Toxicological Effects 

Chronic dietary NOAEL = 3.7 mg/kg/day 

UF = 100 

Chronic RfD = 0.04mg/kg/ 

day 

FQPA SF = 1 

aPAD = chronic RfD/ 

FQPA SF= 0.04 mg/ 

kg/day 

2–Generation Reproduction rat 

Parental 

LOAEL = 22 mg/kg/day basedon increased 

kidney weights, kidney hyaline deposition, 

increased blood serum LH (F1 females) 

Cancer Suggestive evidence of carcinogenic potential 

UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose, MOE = margin of exposure, LOC = level of 

concern, NA = Not Applicable 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. Tolerances are being 

proposed for the combined residues of 

flonicamid and its metabolites, in or on 

a variety of raw agricultural 

commodities. Risk assessments were 

conducted by EPA to assess dietary 

exposures from flonicamid and its 

metabolites in food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1–day or single 

exposure. No such effects were 

identified in the toxicological studies 

for flonicamid; therefore, a quantitative 

acute dietary exposure assessment is 

unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the Dietary Exposure 

Evaluation Model software with the 

Food Commodity Intake Database 

(DEEM-FCIDTM Version 2), which 

incorporates food consumption data as 

reported by respondents in the USDA 

1994–1996 and 1998 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 chronic exposure 

assessments: 100% crop treated, 

tolerance level residues, and drinking 

water estimated concentration of 0.94 

parts per billion (ppb). 

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

flonicamid and its metabolites 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 flonicamid and its 

metabolites. 

The Agency uses the Generic 

Estimated Environmental Concentration 

(GENEEC) or the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) to estimate 

pesticide concentrations in surface 

water and Screening Concentrations in 

Groundwater (SCI-GROW), which 

predicts pesticide concentrations in 

ground water. In general, EPA will use 

GENEEC (a Tier 1 model) before using 

PRZM/EXAMS to estimate pesticide 

concentrations (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 

screen for sorting out pesticides for 

which it is unlikely that drinking water 

concentrations would exceed human 

health levels of concern. 

In order to fully implement the 

requirements of FQPA, EPA determined 

that chronic estimated drinking water 

concentrations (EDWCs) can be used 

directly in chronic dietary exposure 

assessments to calculate aggregate 

dietary (food + water) risk. This is done 

by using the relevant PRZM-EXAMS 

value as a residue for water (all sources) 

in the dietary exposure assessment. The 

principal advantage of this approach is 

that the actual individual body weight 

and water consumption data from the 

CSFII are used, rather than assumed 

weights and consumption for broad age 

groups. This refinement has been used 

for the flonicamid chronic aggregate risk 

assessment for surface water. 

Based on the PRZM/EXAMS and SCIGROW models, the EDWCs of combined 

residues of flonicamid and its 

metabolites for chronic exposures are 

estimated to be 0.94 ppb for surface 

water and 0.00137 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). 

Flonicamid is not registered for use 

on any sites that would result in 

residential exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of the FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

flonicamid and any other substances, 

and flonicamid does not appear to 

produce a toxic metabolite produced by 

other substances. EPA considered that 

there might be a common mechanism 

among flonicamid and other pesticides. 

EPA concluded that the evidence did 

not support a finding of common 

mechanism for flonicamid and other 

pesticides. For the purposes of this 

tolerance action, therefore, EPA has not 

assumed that flonicamid has a common 

mechanism of toxicity with other 

51612 Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 

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 policy statements released by 

EPA’s Office of Pesticide Programs 

concerning common mechanism 

determinations and procedures for 

cumulating effects from substances 

found to have a common mechanism on 

EPA’s website at http://www.epa.gov/ 

pesticides/cumulative/. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408 of FFDCA 

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 based on reliable data 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 MOE analysis or through using 

uncertainty (safety) factors in 

calculating a dose level that poses no 

appreciable risk to humans. In applying 

this provision, EPA either retains the 

default value of 10X when reliable data 

do not support the choice of a different 

factor, or, if reliable data are available, 

EPA uses a different additional safety 

factor value based on the use of 

traditional uncertainty factors and/or 

special FQPA safety factors, as 

appropriate. 

2. Prenatal and postnatal sensitivity. 

There was no evidence for quantitative 

or qualitative susceptibility following 

oral or dermal exposures to rats in utero 

or oral exposure to rabbits in utero. 

Following oral exposures to rats, 

developmental effects were seen only in 

the presence of maternal toxicity. No 

developmental effects were seen in 

rabbits. 

The degree of concern for prenatal 

and/or postnatal susceptibility is low 

due to the lack of evidence of qualitative 

and quantitative susceptibility. This is 

because developmental effects were 

only seen in one species, only at the 

maternal toxicity dose, and effects seen 

in offspring were not more severe than 

those seen in the maternal toxicity. 

Thus, neither qualitative nor 

quantitative susceptibility issues are of 

concern for flonicamid. The database for 

required developmental and 

reproductive studies is complete, thus 

there are no residual uncertainties. 

3. Conclusion. The FQPA Safety 

Factor is reduced to 1X because: 

i. There is a complete toxicity 

database; 

ii. There is a lack of susceptibility 

evidence in the developmental studies 

and reproductive study (The effects seen 

in offspring were mild and occurred 

only in one species.); 

iii. The dietary food exposure 

assessment utilizes proposed tolerance 

level or higher residues and 100% CT 

information for all commodities; and 

iv. The dietary drinking water 

assessment (Tier 1 estimates) utilizes 

values generated by model and 

associated modeling parameters which 

are designed to provide conservative, 

health protective, high-end estimates of 

water concentrations. 

E. Aggregate Risks and Determination of 

Safety 

1. Acute risk. No acute risk is 

expected for the following reasons: No 

acute toxicity endpoint was identified. 

There was no endpoint noted in the 

database from a single dose exposure 

that could be used for risk assessment. 

This included the acute neurotoxicity 

and developmental toxicity studies as 

well as other short- and long-term 

studies. Body weight decreases were 

consider inappropriate for this acute 

endpoint since in these studies they 

occur later then the acute time interval. 

The observed vomiting in either the 

acute or subchronic dog studies 

occurred without manifestations of any 

other acute clinical signs or related 

pathology. Thus acute clinical effects 

seen in the dog studies were considered 

not appropriate. The acute neurotoxicity 

study was also not appropriate for the 

general population since the effects 

observed only occurred in the high 

doses tested where mortality was also 

observed, and therefore the 

neurotoxicity signs were probably part 

of the death response. While death can 

be an acute response, the dose at which 

death occurred was in EPA’s judgement, 

so high that it is unlikely to happen. In 

addition, the acute neurotoxicity study 

did not have all the required 

observations. The effects observed in the 

developmental studies were not 

attributable to an acute response, and 

therefore the developmental studies 

were not used for an acute endpoint for 

females of reproductive age. Thus, an 

acute dietary endpoint was not 

considered appropriate. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to flonicamid and its 

metabolites from food and drinking 

water will utilize 11% of the cPAD for 

the U.S. population, 15% of the cPAD 

for all infants <1 year old, and 25% of 

the cPAD for children 1-2 years old. 

There are no residential uses for 

flonicamid that result in chronic 

residential exposure to flonicamid. 

3. Short-term and intermediate 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). Intermediate-term 

aggregate exposure takes into account 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Flonicamid 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. 

4. Aggregate cancer risk for U.S. 

population. In assessing the 

carcinogenic potential of flonicamid, 

EPA took into account the following 

weight-of-the-evidence considerations: 

i. Flonicamid is not mutagenic. 

ii. The treatment-related CD-1 mouse 

lung tumors (benign and malignant) 

which occurred in both sexes were due 

to an established mitogenic mode of 

action that occurred in a susceptible 

mouse strain with a high background. A 

clear species difference was observed 

between mice and rats in the incidence 

of lung tumors and the BrdU Index 

studies. (Bromodeoxyuridine (BrdU) 

Index studies are used to quantify rates 

of cell proliferation). No tumors were 

seen in the lungs of rats. The flonicamid 

induced increase in the BrdU Index 

appears to be related to the different 

sensitivity of strains of mice, with the 

CD-1 mice being a relatively sensitive 

strain. 

iii. The only other tumor response 

was nasolacrimal duct tumors which 

occurred in female rats at the high dose 

which were considered to be possibly 

treatment-related, but a clear association 

with treatment could not be made. 

Unlike male rats, the nasal tumor 

response in females could not be clearly 

associated with spontaneous 

inflammation related to malocclusion of 

incisor teeth, due to the low incidence 

of both the neoplastic and nonneoplastic lesions. Given these findings 

in the cancer and mutagenicity studies, 

EPA regards the carcinogenic potential 

of flonicamid as very low and concludes 

that it poses no greater than a negligible 

cancer risk to humans. 

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 flonicamid 

residues. 

Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 51613 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methods are 

available to enforce the proposed 

tolerances of flonicamid and the major 

metabolites in plants and livestock. The 

proposed method for plants uses a LC/ 

MS/MS (FMC No. P-3561M) to 

determine the residues of flonicamid 

and its major metabolites, TFNA-AM (4- 

trifluoromethylnicotinamide), TFNA (4- 

trifluoromethylnicotinic acid), and 

TFNG [N-(4- 

trifluoromethylnicotinoyl)glycine]. The 

reported LOQ was 0.01 ppm and the 

reported LOD was 0.005 ppm for peach, 

potato, processed commodities of 

apples, plums, potatoes, and tomatoes. 

The reported LOQ was 0.02 ppm and 

the LOD was 0.01 ppm for each analyte 

in/on wheat; cotton seed, hulls, and 

refined oil. The method was adequately 

validated by an independent laboratory. 

For livestock, three methods were 

proposed: LC/MS/MS method (RCC No. 

844743) for residues in eggs and 

livestock tissues, LC/MS method (RCC 

No. 842993) for residues in milk, and 

LC/MS/MS method (FMC P3580) which 

include an acid hydrolysis step for 

residues in cattle muscle, kidney and 

liver. The three livestock methods 

recommend the use of calibration 

standards, prepared by using control 

matrix extracts for all or some of the 

analyze/matrix combinations to remove 

matrix enhancement effects. The 

methods were adequately validated by 

an independent laboratory. These 

methods may be used for the 

determination of residues of flonicamid 

and its metabolites TFNA-AM, TFNG, 

and TFNA. The validated LOQ was 0.01 

ppm and LOD was 0.005 ppm for 

methods 844743 and 842993; the 

reported validated LOQ was 0.025 ppm 

and the LOD was 0.005 ppm for method 

FMC P3580. 

Enforcement methodology may be 

requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; e-mail address: 

residuemethods@epa.gov. 

B. International Residue Limits 

No Codex, Mexican or Canadian 

MRLs or tolerances have been 

established. Therefore no compatibility 

questions exist with respect to Codex. 

C. Response to Comments 

EPA received one comment from the 

National Cotton Council, which stated 

that it supports ISK Bioscience’s request 

for the establishment of tolerances in 

the listed food and feed items. In today’s 

action, EPA is responding affirmatively 

to this comment. 

V. Conclusion 

Therefore, tolerances are established 

for the combined residues of flonicamid 

[N-(cyanomethyl)-4-trifluoromethyl)-3- 

pyridinecarboxamide], and its 

metabolites TFNA [4- 

trifluoromethylnicotinic acid], TFNAAM [4-trifluoromethylnicotinamide] 

and TFNG [N-(4- 

trifluoromethylnicotinoyl)glycine] in or 

on the crops at tolerance levels listed in 

Unit III. 

Tolerances are established for the 

combined residues of flonicamid [N- 

(cyanomethyl)-4-(trifluoromethyl)-3- 

pyridinecarboxamide], and its 

metabolites TFNA [4- 

trifluoromethylnicotinic acid] and 

TFNA-AM [4- 

trifluoromethylnicotinamide] in or on 

the livestock commodities at tolerance 

levels listed in Unit III. 

VI. Objections and Hearing Requests 

Under section 408(g) of FFDCA, as 

amended by 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 FFDCA 

by FQPA, EPA will continue to use 

those procedures, with appropriate 

adjustments, until the necessary 

modifications can be made. The new 

section 408(g) of FFDCA 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) of FFDCA, as was 

provided in the old sections 408 and 

409 of FFDCA. 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 ID number 

OPP–2005–0217 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 October 31, 2005. 

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 issue(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 (1900L), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. You may also deliver 

your request to the Office of the Hearing 

Clerk in Suite 350, 1099 14th St., NW., 

Washington, DC 20005. 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) 564–6255. 

2. 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 ADDRESSES. Mail your 

copies, identified by docket ID number 

OPP–2005–0217, 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 20460–0001. In person 

or by courier, bring a copy to the 

location of the PIRIB described in 

ADDRESSES. You may also send an 

electronic copy of your request via email 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 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: 

51614 Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 

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 

issue(s) in the manner sought by the 

requestor would be adequate to justify 

the action requested (40 CFR 178.32). 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this rule has 

been exempted from review under 

Executive Order 12866 due to its lack of 

significance, this rule is not subject to 

Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001). 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 

special considerations under Executive 

Order 12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994); or 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 section 408(d) of FFDCA, 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 section 408(n)(4) of 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive Order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

VIII. Congressional Review Act 

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: August 19, 2005. 

Lois A. Rossi, 

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 180.613 is added to read as 

follows: 

§ 180.613 Flonicamid; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for the combined residues of 

flonicamid [N-(cyanomethyl)-4- 

(trifluoromethyl)-3- 

pyridinecarboxamide] and its 

metabolites TFNA [4- 

trifluoromethylnicotinic acid], TFNAAM [4-trifluoromethylnicotinamide] 

TFNG [N-(4- 

trifluoromethylnicotinoyl)glycine] in or 

on the following raw agricultural 

commodities: 

Commodity Parts per million 

Cotton, gin byproducts .................... 6.0 

Cotton, hulls .......... 2.0 

Cotton, meal ......... 1.0 

Cotton, undelinted 

seed .................. 0.50 

Fruit, pome, group 

11 ...................... 0.20 

Fruit, stone, group 

12 ...................... 0.60 

Potato ................... 0.20 

Potato, granular/ 

flakes ................. 0.40 

Spinach ................. 9.0 

Tomato, paste ....... 2.0 

Tomato, puree ...... 0.50 

Vegetable, 

cucurbit, group .. 0.40 

Vegetable, fruiting, 

group ................. 0.40 

Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 51615 

Commodity Parts per million 

Vegetable, leafy 

except Brassica 

group 4, except 

spinach .............. 4.0 

(2) Tolerances are established for 

combined residues of flonicamid [N- 

(cyanomethyl)-4-(trifluoromethyl)-3- 

pyridinecarboxamide], and its 

metabolites TFNA [4- 

trifluoromethylnicotinic acid], TFNAAM [4-trifluoromethylnicotinamide] in 

or on the following raw agricultural 

commodities: 

Commodity Parts per million 

Cattle, fat .............. 0.02 

Cattle, meat .......... 0.05 

Cattle, meat byproducts ............ 0.08 

Egg ....................... 0.03 

Goat, fat ................ 0.02 

Goat, meat ............ 0.05 

Goat, meat byproducts .................... 0.08 

Horse, fat .............. 0.02 

Horse, meat .......... 0.05 

Horse, meat byproducts ............ 0.08 

Milk ....................... 0.02 

Poultry, fat ............ 0.02 

Poultry, meat ........ 0.02 

Poultry, meat byproducts ............ 0.02 

Sheep, fat ............. 0.02 

Sheep, meat ......... 0.05 

Sheep, meat by 

products ............ 0.08 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 05–17128 Filed 8–30–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[OPP–2005–0165; FRL–7719–8] 

Halosulfuron-methyl; Pesticide 

Tolerances for Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

time-limited tolerance for residues of 

halosulfuron-methyl in or on sweet 

potatoes. This action is in response to 

EPA’s granting of an emergency 

exemption under section 18 of the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) authorizing 

use of the pesticide on sweet potatoes. 

This regulation establishes a maximum 

permissible level for residues of 

halosulfuron-methyl in this food 

commodity. The tolerance will expire 

and is revoked on December 31, 2008. 

DATES: This regulation is effective 

August 31, 2005. Objections and 

requests for hearings must be received 

on or before October 31, 2005. 

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VII. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under docket 

identification (ID) number OPP–2005–

0165. All documents in the docket are 

listed in the EDOCKET index at http:// 

www.epa.gov/edocket/. Although listed 

in the index, some information is not 

publicly available, i.e., Confidential 

Business Information (CBI) or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available either 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 S. Bell St., 

Arlington, VA. This docket facility is 

open from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The docket telephone number 

is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Andrew Ertman, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9367; e-mail address: 

ertman.andrew@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

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 this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document and Other Related 

Information? 

In addition to using EDOCKET (http:// 

www.epa.gov/edocket/), you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr/. A 

frequently updated electronic version of 

40 CFR part 180 is available on E-CFR 

Beta Site Two at http:// 

www.gpoaccess.gov/ecfr/. 

II. Background and Statutory Findings 

EPA, on its own initiative, in 

accordance with sections 408(e) and 

408(l)(6) of the Federal Food, Drug, and 

Cosmetic Act (FFDCA), 21 U.S.C. 346a, 

is establishing a tolerance for residues of 

the herbicide halosulfuron-methyl, in or 

on sweet potatoes at 1.0 parts per 

million (ppm). This tolerance will 

expire and is revoked on December 31, 

2008. EPA will publish a document in 

the Federal Register to remove the 

revoked tolerance from the Code of 

Federal Regulations (CFR). 

Section 408(l)(6) of FFDCA requires 

EPA to establish a time-limited 

tolerance or exemption from the 

requirement for a tolerance for pesticide 

chemical residues in food that will 

result from the use of a pesticide under 

an emergency exemption granted by 

EPA under section 18 of FIFRA. Such 

tolerances can be established without 

providing notice or period for public 

comment. EPA does not intend for its 

actions on FIFRA section 18 related 

tolerances to set binding precedents for 

the application of section 408 of FFDCA 

and the new safety standard to other 

tolerances and exemptions. Section 

408(e) of FFDCA allows EPA to 

establish a tolerance or an exemption 

from the requirement of a tolerance on 

its own initiative, i.e., without having 

received any petition from an outside 

party. 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’