55752 Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 

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. 801et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of this final 

rule in the Federal Register. This final 

rule is not a ‘‘major rule’’ as defined by 

5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 15, 2005. 

James Jones, 

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 180.614 is added to read as 

follows: 

§ 180.614 Kasugamycin; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of kasugamycin, 

3-O-[2-amino-4- 

[(carboxyiminomethyl)amino]-2,3,4,6- 

tetradeoxy-a-D-arabino-hexopyranosyl]- 

D-chiro-inositol in or on the following 

raw agricultural commodity: 

Commodity Parts per million 

Vegetable, fruiting group 

81 ................................. 0.04 

1There is no U.S. registration as of September 1, 2005. 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 05–19061 Filed 9–22–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[OPP–2005–0185; FRL–7736–3] 

Amicarbazone; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

amicarbazone and its metabolites in or 

on field corn and livestock commodities 

and indirect or inadvertent residues of 

amicarbazone and its metabolites in 

alfalfa, cotton, soybean and wheat. 

Arysta Lifescience North American 

Corporation (perviously known as 

Arvesta Corporation) 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 

September 23, 2005. Objections and 

requests for hearings must be received 

on or before November 22, 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–

0185. 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., 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. 

Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 55753 

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: 

Joanne I. Miller, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6224; e-mail address: 

miller.joanne@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 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 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 at http://www.epa.gpo/ 

opptsfrs/home/guidelin.htm/. 

II. Background and Statutory Findings 

In the Federal Register of January 22, 

2004 (69 FR 3138) (FRL–7339–3), 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 0F6131) by Arysta 

Lifescience North American 

Corporation, 100 First Street, Suite 

1700; San Francisco, CA 94105. The 

petition requested that 40 CFR part 180 

be amended by establishing tolerances 

for combined residues of the herbicide 

amicarbazone, 4-amino-4,5-dihydro-N- 

(1,1-dimethylethyl)-3-(1-methylethyl)-5- 

oxo-1H-1,2,4-triazole-1-carboxamide] 

and its metabolities DA amicarbazone 

(N-(1,1-dimethylethyl)-4,5-dihydro-3-(1- 

methylethyl)-5-oxo-1H,2,4-triazole-1- 

carboxamide) and iPr-2-OH DA 

amicarbazone (N-(1,1-dimethylethyl)- 

4,5-dihydro-3-(1-hydroxy-1- 

methylethyl)-5-oxo-1H-1,2,4-triazole-1- 

carboxamide), in or on the raw 

agricultural commodities alfalfa forage 

at 0.04 parts per million (ppm); alfalfa 

hay at 0.06 ppm; corn forage at 0.8ppm; 

corn grain, at 0.05 ppm; corn stover at 

0.5 ppm; cotton gin by-product at 0.2 

ppm; cottonseed hulls at 0.01 ppm; 

cottonseed meal at 0.01 ppm; cottonseed 

refined oil at 0.01 ppm; cotton 

undelinted seed at 0.04 ppm; soybean 

forage at 2.5 ppm; soybean hay at 7.0 

ppm; soybean hulls at 0.2 ppm; soybean 

meal at 0.25 ppm; soybean oil at 0.01 

ppm; soybean seed at 0.6 ppm; wheat 

bran at 0.08 ppm; wheat flour at 0.05 

ppm; wheat forage at 0.6 ppm; wheat 

germs at 0.05 ppm; wheat grain at 0.09 

ppm; wheat hay at 0.9 ppm; wheat 

middlings at 0.05 ppm; wheat shorts at 

0.06 ppm; wheat straw at 0.4 ppm; 

sugarcane at 0.15 ppm; sugarcane 

molasses at 0.8 ppm; meat (cattle, goats, 

hogs, horses, and sheep) at 0.01 ppm; 

meat byproducts (cattle, goats, hogs, 

horses,and sheep) at 0.2 ppm; and milk 

at 0.01 ppm respectively. 

Due to a lack of field trial data on 

sugarcane, tolerances on sugarcane and 

sugarcane molasses are not being 

established at this time. 

One comment was received in 

response to the notice filing. B. Sachau 

objected to the proposed tolerances 

because of the amounts of pesticides 

already consumed and carried by the 

American population. She further 

indicated that testing conducted on 

animals have absolutely no validity and 

are cruel to the test animals. EPA’s 

response to these comments is 

contained 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 amicarbazone [4-amino-4, 5- 

dihydro- N-(1,1-dimethylethyl)-3-(1- 

methylethyl)-5-oxo-1H-1,2,4-triazole-1- 

carboxamide] and its metabolites DA 

amicarbazone [N-(1,1-dimethylethyl)- 

4,5-dihydro-3-(1-methylethyl)-5-oxo-1H1,2,4-triazole-1-carboxamide] and iPr-2- 

OH DA amicarbazone [N-(1,1- 

dimethylethyl)-4,5-dihydro-3-(1- 

hydroxy-1-methylethyl)-5-oxo-1H-1,2,4- 

triazole-1-carboxamide], calculated as 

parent equivalents, in or on corn, field, 

forage at 0.80 ppm; corn, field, grain at 

0.05 ppm; corn, field, stover at 1.0 ppm; 

cattle, fat at 0.01 ppm; cattle, liver at 1.0 

ppm; cattle, meat at 0.01 ppm; cattle, 

meat byproducts, except liver at 0.10 

ppm; goat, fat at 0.01 ppm; goat, liver at 

1.0 ppm; goat, meat at 0.01 ppm; goat, 

meat byproducts, except liver at 0.1 

55754 Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 

ppm; hog, fat at 0.01 ppm; hog, liver at 

0.1 ppm; hog, meat at 0.01 ppm; hog, 

meat byproducts, except liver at 0.01 

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

at 1.0 ppm; horse, meat at 0.01 ppm; 

horse, meat byproducts, except liver at 

0.10 ppm; milk at 0.01 ppm; sheep, fat 

at 0.01 ppm; sheep, liver at 1.0 ppm; 

sheep, meat at 0.01 ppm; sheep, meat 

byproducts, except liver at 0.10 ppm; 

poultry, liver at 0.01 ppm. EPA can also 

make a determination on aggregate 

exposure for the establishment of 

tolerances for the indirect or inadvertent 

residues of amicarbazone and its 

metabolites DA amicarbazone and iPr-2- 

OH DA amicarbazone, calculated as 

amicarbazone, in or on the following 

raw agricultural commodities when 

present therein as a result of the 

application of amicarbazone to field 

corn: Alfalfa, forage at 0.05 ppm; alfalfa, 

hay at 0.10 ppm; cotton, undelinted 

seed at 0.07 ppm; cotton, gin byproducts 

at 0.30 ppm; soybean, forage at 1.50 

ppm; soybean, hay at 5.0 ppm; soybean, 

seed at 0.80 ppm; wheat, forage at 0.50 

ppm; wheat, hay at 1.0 ppm; wheat, 

grain at 0.10 ppm; wheat, straw at 0.50 

ppm; wheat, grain, milled byproducts at 

0.15 ppm. 

EPA’s assessment of exposures and 

risks associated with establishing the 

tolerances 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 

amicarbazone are discussed in Table 1 

of this unit as well as the no observed 

adverse effect level (NOAEL) and the 

lowest observed adverse effect level 

(LOAEL) from the toxicity studies 

reviewed. 

TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY

Guideline No. Study Type Results 

870.3100 90–Day oral toxicity - rodents (rats) NOAEL = 33/38 milligram/kilogram/day (mg/kg/day) 

LOAEL = 67/78 mg/kg/day based on decreased bodyweight (BW) 

female and overall (weeks 1–13) bodyweight gain (BWG), decreased red cell indices, clinical chemistry (increased cholesterol, 

T4 and T3 males, O-demethylase females, N-demethylase 

males), increased relative liver weights females, and 

histopathology effects in males (minimal hepatocytomegaly and 

minimal pigmentation in the spleen) 

870.3150 90–Day oral toxicity - nonrodents 

(dogs) 

NOAEL = 6.28 mg/kg/day 

LOAEL = 24.99 mg/kg/day based on increased thyroid vacuolization 

and decreased food consumption and glucose in females; increased platelets, phosphate, bile acids, absolute and relative 

liver weights, and lymphoid hyperplasia of the gall bladder in 

males; and decreased albumin and increased triglycerides, Ndemethylase, and O-demthylase in both sexes. 

870.3200 21/28–Day dermal toxicity NOAEL = 1,000 mg/kg/day 

LOAEL = Not Observed 

870.3700 Prenatal developmental in rats Maternal NOAEL = 15 mg/kg/day 

LOAEL = 100 mg/kg/day based on decreased BW/BWG and food 

consumption, and increased incidences of hard stools. 

Developmental NOAEL = 15 mg/kg/day 

LOAEL = 100 mg/kg/day based on multiple skeletal development retardations (incomplete ossification/unossification was observed in 

parietal bones, interparietal bones, supraoccipital bones, 

squamosal bones, zygoma, pubis, xiphoid, and fontanelle 

870.3700 Prenatal developmental in rabbits Maternal NOAEL = 5 mg/kg/day 

LOAEL = 20 mg/kg/day based on decreased BWG during treatment. 

Developmental NOAEL = 20 mg/kg/day 

LOAEL = 70 mg/kg/day based on decreased fetal BW, and increased incidences of incomplete ossification of the 5th medial 

phalanx (bilateral) and the 13th caudal vertebra, and slightly thick 

ribs. 

870.3800 Reproduction and fertility effects Parental/Systemic NOAEL = 6.4/7.3 mg/kg/day 

LOAEL = 33.9/38.7 mg/kg/day based on decreased BW/BWG in 

both sexes. 

Reproductive NOAEL = 73.2/84.0 mg/kg/day 

LOAEL = Not Observed 

Offspring NOAEL = 6.4/7.3 mg/kg/day 

LOAEL = 33.9/38.7 mg/kg/day based on decreased pup BW and 

overall decreased BWG. 

Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 55755 

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

Guideline No. Study Type Results 

870.4100 Chronic toxicity in rodents (rats) NOAEL = 2.3/2.7 mg/kg/day 

LOAEL = 25.3/29.5 mg/kg/day based on decreased BW in females 

and BWG in both sexes. 

At the doses tested there was not a treatment related increase in 

tumor incidence when compared to control. Dosing was considered adequate based on decreased BW in females and BWG in 

both sexes. 

870.4100 Chronic toxicity dogs (beagle) NOAEL =2.5/2.3 mg/kg/day 

LOAEL = 8.9/8.7 mg/kg/day based on effects on the liver, including 

increased absolute and relative liver weights, and O-demethylase 

in males; increased globulin and cytochrome P-450 in females; 

and increased triglycerides and cholesterol in both sexes. 

870.4300 Carcinogenicity-mice NOAEL = 244.7/275.0 mg/kg/day 

LOAEL = 709.0/806.3 mg/kg/day based on decreased BW and 

BWG in both sexes, and subclinical anemia, and hemosiderin pigmentation of the spleen in males. 

no evidence of carcinogenicity 

At the doses tested there was not a treatment related increase in 

tumor incidence when compared to control. Dosing was considered adequate based on decreased BW and BWG in both sexes, 

and subclinical anemia, and hemosiderin pigmentation of the 

spleen in males. 

870.5100 Bacterial reverse mutation test There was no evidence of induced mutant colonies over background. 

870.5100 Bacterial reverse mutation test There was no evidence of induced mutant colonies over background. 

870.5100 Bacterial reverse mutation test There was no evidence of induced mutant colonies over background. 

870.5300 In vitro mammalian cell gene mutation test There was no evidence that MKH3586 induced mutant colonies over 

background in the presence or absence of S9-activation. 

870.5375 In vitro mammalian chromosome aberration test There was no evidence of chromosome aberration induced over 

background in the presence or absence of S9-activation. 

870.5395 Mammalian erythrocyte micronucleus test There was no significant increase in the frequency of 

micronucleated polychromatic erythrocytes in bone marrow at any 

treatment time. 

870.6200 Acute neurotoxicity screening battery in rats (Fischer-344) NOAEL = 10 mg/kg/day 

LOAEL = 20 mg/kg/day based on eyelid ptosis, decreased approach 

response (both sexes), and red nasal staining in males. 

A series of acute neurotoxicity studies were performed, the NOAEL 

for this study comes from 45121527. 

870.6200 Subchronic neurotoxicity screening 

battery in rats (Fischer-344) 

Female: NOAEL = 7.8 mg/kg/day 

LOAEL = 38.2 mg/kg/day based on decreased BW and overall BWG 

in females. 

Male: NOAEL = 66.5 mg/kd/day 

LOAEL = was not observed for males. 

870.6300 Developmental neurotoxicity in rats Maternal NOAEL = 8 mg/kg/day 

LOAEL = 39 mg/kg/day based primarily on decreased feed efficiency (combination of decreased BWG and increased food consumption) during lactation. 

Offspring NOAEL = 39 mg/kg/day 

LOAEL = 91 mg/kg/day based on decreased BWG. 

870.7485 Metabolism and pharmacokinetics 95% of the radioactive dose was recovered within 72 hours following dosing. The majority of the dose was recovered from the 

urine within 24 hours (64%), indicating substantial absorption. 

Fecal excretion accounted for 27% of the dose within 24 hours. 

Major metabolites were DA MKH, N-methyl DA MKH, and 

decarboxamide. 

55756 Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 

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

Guideline No. Study Type Results 

870.7485 Metabolism and pharmacokinetics 91% of the radioactive dose was recovered within 96 hours. Urinary 

excretion accounted for 70% of the radioactive dose within 12 

hours, showing substantial absorption. Only 8% of the radioactive 

dose was excreted via the feces within 24 hours. 

Non-guideline Subchronic mechanistic feeding in 

rats 

Thyroid hormones were increased in the >19.4 mg/kg/day females 

and 40.0 mg/kg/day males. However, thyroid to blood ratios of 

125I in treated groups were comparable to negative controls, indicating there was no impairment of thyroid hormone synthesis. 

Thus, the differences in thyroid hormones is probably due to metabolism at an extra-thyroidal site. The liver was implicated as this 

site because liver weights and UDP-glucuronosyltransferase activity were increased. 

Non-guideline In vitro studies on enzymes of thyroid hormone regulation MKH 3586 does not affect the iodide organification step of thyroid 

hormone synthesis or the peripheral metabolism of thyroid hormones via Type I or Type II deiodinases in vivo. These findings 

support the subchronic mechanistic studies in rats which indicate 

that upregulation of UDP-glucuronosyl transferase in the liver may 

account for alterations in thyroid hormone profile. 

Non-guideline Behavioral study in rats The following clinical signs were observed: Sedation, ptosis, salivation. Additionally at the HDT, piloerection, Straub phenomenon, 

and prone position were observed. The effects were observed at 

30 minutes post dose, and no effect was observed at 150 minutes 

post dose, with the higher dose groups showing greater persistence of effects. A dose- and time-dependent effect was demonstrated on motor activity - decreased travel distance, increased 

resting time, and decreased rearing. 

Non-guideline Study of central nervous system 

safety pharmacology in mice 

The data indicate that a single dose of MKH 3586 at 100 mg/kg 

causes minimal CNS functional impairment, characterized by increased reaction times to nociceptive stimuli, reduced traction 

force, impaired motor coordination, sedation, partial ptosis, and a 

mild anticonvulsive effect. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, 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 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. 

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 

uncertainty 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 = NOAE/UF). 

Where a special FQPA safety factor or 

the default FQPA safety factor is used, 

this additional 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 exposures (margin of 

exposure (MOE) = NOAEL/exposure) is 

calculated and compared to the LOC. 

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify nonthreshold hazards such as cancer. The 

Q* approach assumes that any amount 

of exposure will lead to some degree of 

cancer risk, estimates risk in terms of 

the probability of occurrence of 

additional cancer cases. An example of 

how such a probability risk is expressed 

would be to describe the risk as one in 

one hundred thousand (1 X 10-5), one in 

a million (1 X 10-6), one in a ten million 

(1 X 10-7). Under certain specific 

circumstances, MOE calculations will 

be used for the carcinogenic risk 

assessment. In this non-linear approach, 

a ‘‘point of departure’’ is identified 

below which carcinogenic effects are 

not expected. The point of departure is 

typically a NOAEL based on an 

endpoint related to cancer effects 

though it may be a different value 

Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 55757 

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 amicarbazone used for 

human risk assessment is shown in 

Table 2 of this unit: 

TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR AMICARBAZONE FOR USE IN HUMAN RISK

ASSESSMENTS

Exposure Scenario Dose Used in Risk Assessment UF 

Special FQPA SF* and 

LOC for Risk Assessment Study and Toxicological Effects 

Acute dietary 

(females 13–49 years of age) 

NOAEL = 10 mg/kg/day 

UF = 100X 

Acute RfD = 0.10 mg/kg/ 

day 

Special FQPA SF = 1X 

aPAD = 0.10 mg/kg/day 

Acute neurotoxicity screening battery 

LOAEL = 20 mg/kg/day, based on eyelid ptosis, decreased approach response, red nasal 

staining in male rats. 

Acute dietary 

(general population) 

NOAEL = 10 mg/kg/day 

UF = 100X 

Acute RfD = 0.10 mg/kg/ 

day 

Special FQPA SF = 1X 

aPAD = 0.10 mg/kg/day 

Acute neurotoxicity screening battery 

LOAEL = 20 mg/kg/day, based on eyelid ptosis, decreased approach response, red nasal 

staining in male rats. 

Chronic dietary 

(all populations) 

NOAEL = 2.3 mg/kg/day 

UF = 100X 

Chronic RfD = .023 mg/kg/ 

day 

Special FQPA SF = 1X 

cPAD = 0.023 mg/kg/day 

Chronic rat and chronic dog 

LOAEL = 25.3 and 8.7, respectively, based on 

rat - decreased BW and BWG dog - liver effects, including increased absolute and relative liver weights, and O-demethylase in 

male dogs; increased globulin and 

cytochrome p450 in female dogs; and increased triglycerides and cholesterol in both 

sexes 

Dermal (all durations) Not required: No systemic toxicity by dermal route was seen at the limit dose. Evidence of low dermal absorption. 

Inhalation short-term 

(1 - 30 days) 

NOAEL = 6.28 mg/kg/day LOC for MOE = 100 90–Day oral toxicity in dogs 

LOAEL = 24.99 mg/kg/day, based on increased 

thyroid vacuolization and decreased food 

consumption and glucose in females; increased platelets, phosphate, bile acids, absolute and relative liver weights, and lymphoid hyperplasia of the gall bladder in males; 

and decreased albumin and increased 

triglycerides, N-demethylase, and Odemethylase in both sexes 

Inhalation intermediate-term 

(1-6 months) 

NOAEL = 6.28 mg/kg/day LOC for MOE = 100 90–Day oral toxicity in dogs 

LOAEL = 24.99 mg/kg/day, based on increased 

thyroid vacuolization and decreased food 

consumption and glucose in females; increased platelets, phosphate, bile acids, absolute and relative liver weights, and lymphoid hyperplasia of the gall bladder in males; 

and decreased albumin and increased 

triglycerides, N-demethylase, and Odemethylase in both sexes 

Cancer (oral, dermal, inhalation) Classification: There was no treatment related increase in tumor incidence when compared to control. Dosing was considered adequate. This chemical is not likely to be a carcinogen. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. No tolerances have been 

established in 40 CFR part 180 

previously for the combined residues of 

amicarbazone, in or on a variety of raw 

agricultural commodities. Risk 

assessments were conducted by EPA to 

assess dietary exposures from 

amicarbazone 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. 

The Dietary Exposure Evaluation 

Model (DEEMTM) analysis evaluated the 

individual food consumption 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 acute exposure 

assessments: For the acute analyses, 

tolerance-level residues were assumed 

for all food commodities with proposed 

amicarbazone tolerances, and it was 

assumed that 100% of all of the crops 

included in the analysis were treated. 

The DEEMTM analyses included 

drinking water in addition to the food 

sources of residues. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the DEEM software with the 

55758 Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 

Food Commodity Intake Database 

(DEEM-FCIDTM), which incorporates 

food consumption data as reported by 

respondents in the USDA 1994–1996 

and 1998 Nationwide CSFII, and 

accumulated exposure to the chemical 

for each commodity. The following 

assumptions were made for the chronic 

exposure assessments: For the chronic 

analyses tolerance-level residues were 

assumed for all food commodities with 

proposed amicarbazone tolerances, and 

it was assumed that 100% of all of the 

crops included in the analysis were 

treated. As with the acute analyses, 

drinking water was included in the 

assessment. 

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

amicarbazone 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 

amicarbazone. 

Based on the FIRST and SCI-GROW 

models, the estimated environmental 

concentrations (EECs) of amicarbazone 

for acute exposures are estimated to be 

21.4 parts per billion (ppb) for surface 

water and 102.9 ppb for ground water. 

The EECs for chronic exposures are 

estimated to be 13.4 ppb for surface 

water and 102.9 ppb for ground water. 

The ground water EEC was used in both 

the acute and chronic DEEM analyses 

described earlier in this section. 

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). 

Amicarbazone 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 

amicarbazone and any other substances 

and amicarbazone 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 amicarbazone has a 

common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see the 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 is no evidence of increased 

susceptibility of rat or rabbit fetuses 

following in utero exposure in the 

developmental studies with 

amicarbazone. There is no evidence of 

increased susceptibility of rats in the 

reproduction study with amicarbazone. 

EPA concluded that there are no 

residual uncertainties for prenatal and/ 

or postnatal exposure. 

3. Conclusion. There is a complete 

toxicity data base for amicarbazone and 

exposure data are complete or are 

estimated based on data that reasonably 

accounts for potential exposures. The 

Agency concluded that there was 

reliable data to remove the 10X 

children’s safety factor based upon the 

following: The toxicity database showed 

no increase in susceptibility in fetuses 

and pups with in utero and post-natal 

exposure; the dietary exposure 

assessment is based on HEDrecommended tolerance-level residues, 

assumes 100% crop treated for all 

commodities, and utilizes high-end 

estimates of concentrations in water; 

and there are no residential uses 

proposed for this chemical at this time. 

E. Aggregate Risks and Determination of 

Safety 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and drinking water 

to amicarbazone will occupy 7% of the 

aPAD for the U.S. population, 6% of the 

aPAD for females 13 years and older, 

23% of the aPAD for the all infant 

subpopulation, which is the 

subpopulation with the greatest 

exposure, and 12% of the aPAD for 

children 1–2 years old. Therefore, EPA 

does not expect the acute aggregate risk 

exposure to exceed 100% of the aPAD. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to amicarbazone from 

food and drinking water will utilize 

14% of the cPAD for the U.S. 

population, 39% of the cPAD for for the 

all infant subpopulation, which is the 

subpopulation with the greatest 

exposure, and 26% of the cPAD for 

children 1–2 years old. There are no 

residential uses for amicarbazone that 

result in chronic residential exposure to 

amicarbazone. Therefore, the aggregate 

risk is the sum of the risk from food and 

water, which do not exceed the 

Agency’s LOC. 

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). 

Amicarbazone is not registered for use 

on any sites that would result in 

residential exposure. Therefore, the 

chronic aggregate risk is the sum of the 

risk from food and water, which do not 

exceed the Agency’s LOC. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). Amicarbazone 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 

does not exceed the Agency’s LOC. 

5. Aggregate cancer risk for U.S. 

population. A cancer dietary exposure 

analysis was not performed because the 

Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 55759 

Agency determined that amicarbazone 

was not likely to cause cancer. 

6. 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 

amicarbazone residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(liquid chromatography/mass 

spectrometry/mass spectrometry) is 

available to enforce the tolerance 

expression. The methods for both plant 

and livestock commodities 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 

There are currently no established 

Codex, Canadian or Mexican residue 

limits for amicarbazone. 

C. Response to Comments 

Ms. Sachau’s comments regarding 

general exposure to pesticides contained 

no scientific data or evidence to rebut 

the Agency’s conclusion that there is a 

reasonable certainty that no harm will 

result from aggregate exposure to 

amicarbazone, including all anticipated 

dietary exposures and all other 

exposures for which there is reliable 

information. This comment as well as 

her comments regarding animal testing 

have been responded to by EPA on 

several occasions. 70 FR 1349 (January 

7, 2005)(FRL–7691–4); 69 FR 63083, 

(October 29, 2004)(FRL–7681–9). 

V. Conclusion 

Therefore, tolerances are established 

for combined residues of amicarbazone 

[4-amino-N-(1,1-dimethyl)-4,5-dihydro3-(1-methylethyl)-5-oxo-1H-1,2,4- 

triazole-1-carboxamide] and its 

metabolites DA amicarbazone [N-(1,1- 

dimethylethyl)-4,5-dihydro-3-(1- 

methylethyl)-5-oxo-1H-1,2,4-triazole-1- 

carboxamide] and iPr-2-OH DA 

amicarbazone [N-(1,1-dimethylethyl)- 

4,5-dihydro-3-(1-hydroxy-1- 

methylethyl)-5-oxo-1H-1,2,4-triazole-1- 

carboxamide], calculated as parent 

equivalents, in or on corn, field, grain at 

0.05 ppm; corn, field, forage at 0.80 

ppm; corn, field, stover at 1.0 ppm; 

cattle, fat at 0.01 ppm; cattle, liver at 1.0 

ppm; cattle, meat at 0.01 ppm; cattle, 

meat byproducts, except liver at 0.10 

ppm; goat, fat at 0.01 ppm; goat, liver at 

1.0 ppm; goat, meat at 0.01 ppm; goat, 

meat byproducts, except liver at 0.1 

ppm; hog, fat at 0.01 ppm; hog, liver at 

0.1 ppm; hog, meat at 0.01 ppm; hog, 

meat byproducts, except liver at 0.01 

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

at 1.0 ppm; horse, meat at 0.01 ppm; 

horse, meat byproducts, except liver at 

0.10 ppm; milk at 0.01 ppm; sheep, fat 

at 0.01 ppm; sheep, liver at 1.0 ppm; 

sheep, meat at 0.01 ppm; sheep, meat 

byproducts, except liver at 0.10 ppm; 

poultry, liver at 0.01 ppm. 

Tolerances are also established for the 

indirect or inadvertent residues of 

amicarbazone and its metabolites DA 

amicarbazone and iPr-2-OH DA 

amicarbazone, calculated as 

amicarbazone, in or on the following 

raw agricultural commodities when 

present therein as a result of the 

application of amicarbazone to field 

corn: Alfalfa, forage at 0.05 ppm; 

Alfalfa, hay at 0.10 ppm; Cotton, 

undelinted seed at 0.07 ppm; Cotton, 

gin byproducts at 0.30 ppm; Soybean, 

forage at 1.50 ppm; Soybean, hay at 5.0 

ppm; Soybean, seed at 0.80 ppm; Wheat, 

forage at 0.50 ppm; Wheat, hay at 1.0 

ppm; Wheat, grain at 0.10 ppm; Wheat, 

straw at 0.50 ppm; Wheat, grain, milled 

byproducts at 0.15 ppm. 

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–2005–0185 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before November 22, 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 VIA, 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–2005–0185, 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. 

55760 Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 

B. When Will the Agency Grant a 

Request for a Hearing? 

A request for a hearing will be granted 

if the Administrator determines that the 

material submitted shows the following: 

There is a genuine and substantial issue 

of fact; there is a reasonable possibility 

that available evidence identified by the 

requestor would, if established resolve 

one or more of such issues in favor of 

the requestor, taking into account 

uncontested claims or facts to the 

contrary; and resolution of the factual 

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: September 12, 2005. 

James Jones, 

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 180.615 is added to subpart 

C to read as follows: 

§ 180.615 Amicarbazone; tolerances for 

residues 

(a) General. Tolerances are 

established for combined residues of the 

herbicide, amicarbazone [4-amino-4, 5- 

dihydro- N-(1,1-dimethylethyl)-3-(1- 

methylethyl)-5-oxo-1H-1,2,4-triazole-1- 

carboxamide] and its metabolites DA 

amicarbazone [N-(1,1-dimethylethyl)- 

4,5-dihydro-3-(1-methylethyl)-5-oxo-1H1,2,4-triazole-1-carboxamide] and iPr-2- 

OH DA amicarbazone [N-(1,1- 

dimethylethyl)-4,5-dihydro-3-(1- 

hydroxy-1-methylethyl)-5-oxo-1H-1,2,4- 

triazole-1-carboxamide], calculated as 

parent equivalents, in or on the 

following commodities: 

Commodity Parts per million 

Cattle, fat ........................ 0.01 

Cattle, liver ...................... 1.0 

Cattle, meat .................... 0.01 

Cattle, meat byproducts, 

except liver .................. 0.10 

Corn, field, forage ........... 0.80 

Corn, field, grain ............. 0.05 

Corn, field, stover ........... 1.0 

Goat, fat .......................... 0.01 

Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 55761 

Commodity Parts per million 

Goat, liver ....................... 1.0 

Goat, meat ...................... 0.01 

Goat, meat byproducts, 

except liver .................. 0.10 

Hog, fat ........................... 0.01 

Hog, liver ........................ 0.10 

Hog, meat ....................... 0.01 

Hog, meat byproducts, 

except liver .................. 0.01 

Horse, fat ........................ 0.01 

Horse, liver ..................... 1.0 

Horse, meat .................... 0.01 

Horse, meat byproducts, 

except liver .................. 0.10 

Milk ................................. 0.01 

Sheep, fat ....................... 0.01 

Sheep, liver ..................... 1.0 

Sheep, meat ................... 0.01 

Sheep, meat byproducts, 

except liver .................. 0.10 

Poultry, liver .................... 0.10 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

Tolerances are established for the 

indirect or inadvertent residues of 

amicarbazone [4-amino-4, 5-dihydro-N- 

(1,1-dimethylethyl)-3-(1-methylethyl)-5- 

oxo-1H-1,2,4-triazole-1-carboxamide] 

and its metabolites DA amicarbazone 

[N-(1,1-dimethylethyl)-4,5-dihydro-3-(1- 

methylethyl)-5-oxo-1H-1,2,4-triazole-1- 

carboxamide] and iPr-2-OH DA 

amicarbazone [N-(1,1-dimethylethyl)- 

4,5-dihydro-3-(1-hydroxy-1- 

methylethyl)-5-oxo-1H-1,2,4-triazole-1- 

carboxamide], calculated as parent 

equivalents, in or on the following 

commodities when present therein as a 

result of application of amicarbazone to 

the growing crops in paragraph (a) of 

this section: 

Commodity Parts per million 

Alfalfa, forage ................. 0.05 

Alfalfa, hay ...................... 0.10 

Cotton, gin byproducts ... 0.30 

Cotton, undelinted seed 0.07 

Soybean, forage ............. 1.50 

Soybean, hay .................. 5.0 

Soybean, seed ................ 0.80 

Wheat, forage ................. 0.50 

Wheat, grain ................... 0.10 

Wheat, grain, milled byproducts ...................... 0.15 

Wheat, hay ..................... 1.0 

Wheat, straw ................... 0.50 

[FR Doc. 05–18951 Filed 9–22–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[OPP–2005–0267; FRL–7738–6] 

Pyridaben; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of pyridaben in 

or on hop, dried cones; papaya; star 

apple; sapote, black; mango; sapodilla; 

sapote, mamey; canistel, fruit, stone, 

group 12; strawberry; and tomato. 

Interregional Research Project Number 4 

(IR-4) requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA), as amended by the Food 

Quality Protection Act of 1996 (FQPA). 

EPA is also deleting certain pyridaben 

tolerances that are no longer needed as 

result of this action. 

DATES: This regulation is effective 

September 23, 2005. Objections and 

requests for hearings must be received 

on or before November 22, 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–

0267. 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., 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: 

Barbara Madden, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6463; e-mail address: 

madden.barbara@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 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 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 at http://www.epa.gpo/ 

opptsfrs/home/guidelin.htm/. 

II. Background and Statutory Findings 

In the Federal Register of July 3, 2003 

(68 FR 39942) (FRL–7315–4), EPA 

issued a notice pursuant to section 

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

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

pesticide petitions (0E6068, 1E6226, 

1E6303, 2E6457, and 2E6460) from IR4, 681 U.S. Highway #1 South, North 

Brunswick, NJ 08902–3390. The