55748 Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 

Commodity Parts per 

million 

* * * * * 

Pea, succulent .......................... 0.02 

* * * * * 

Salal .......................................... 3.0 

* * * * * 

Vegetable, fruiting, group 8 ...... 1.0 

* * * * * 

[FR Doc. 05–19062 Filed 9–22–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[OPP–2005–0017; FRL–7736–4] 

Kasugamycin; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance forresidues of kasugamycin in 

or on fruiting vegetables, crop group 8. 

Arysta Lifescience North American 

Corporation (previously know as 

Arvesta Corporation), agent for Hokko 

Chemical Industry 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 theSUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2005–

0017. 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: 

Mary L. Waller, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9354; e-mail address: 

waller.mary@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 at http://www.epa.gpo/ 

opptsfrs/home/guidelin.htm/. 

II. Background and Statutory Findings 

In the Federal Register of April 8, 

2005 (70 FR 17997) (FRL–7704–2), 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 3E6579) by Arysta 

Lifescience North American 

Corporation, 100 First Street, Ste. 1700; 

San Fransisco, CA 94105; agent for 

Hokko Chemical Industry Corporation 

Ltd., 4-20, Nihonbashi Hongochkucho 4 

Chome, Chuo-Ku, Tokyo 103–8341, 

Japan. The petition requested that 40 

CFR part 180 be amended by 

establishing a tolerance for residues of 

the fungicide kasugamycin, 1L-1,3,4/ 

2,5,6-1-deoxy-2,3,4,5,6-pentahydroxycyclohexyl-2-amino-2,3,4,6-tetradeoxy4-([a]-iminoglycino)-[a]-D-arabinohexapyranoside, in or on fruiting 

vegetables (Crop Group 8) at 0.04 parts 

per million (ppm), tomato juice at 0.06 

ppm, tomato puree at 0.06 ppm, and 

tomato paste at 0.25 ppm. That notice 

included a summary of the petition 

prepared by Arysta Life Science North 

American Corporation, agent for Hokko 

Chemical Industry Corporation, LLC, 

the registrant. Comments were received 

on the notice of filing. EPA’s response 

to these comments is discussed in Unit 

IV.C. below. 

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 http:// 

Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 55749 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm 

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 residues of 

kasugamycin on fruiting 

vegetables(Crop Group 8) at 0.04 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 

kasugamycin as well as the no observed 

adverse effect level (NOAEL) and the 

lowest observed adverse effect level 

(LOAEL) from the toxicity studies can 

be found at http://www.epa.gov/edocket. 

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. 

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. More 

information can be found on the general 

principles of EPA uses in risk 

characterization at http://www.epa.gov/ 

oppfead1/trac/science/. 

A summary of the toxicological 

endpoints for kasugamycin used for 

human risk assessment is shown in 

Table 1 of this unit: 

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR KASUGAMYCIN FOR USE IN HUMAN RISK

ASSESSMENT

Exposure/Scenario 

Dose Used in Risk Assessment, Interspecies and 

Intraspecies and any Traditional UF 

Special FQPA SF and 

Level of Concern for Risk 

Assessment 

Study and Toxicological Effects 

Acute dietary (females 13–50 

years of age and general 

population including infants 

and children) 

None None Not Selected 

No appropriate dose and endpoint could 

beidentified for these population groups 

Chronic dietary (all populations) NOAEL = 11.3 mg/kg/day 

UF = 100 

Chronic RfD = 0.113 mg/kg/ 

day 

Special FQPA SF = 1 

cPAD = chronic RfD/Special FQPA SF = 0.113 

mg/kg/day 

Combined chronic toxicity/oncogenicity study 

in rats 

LOAEL = 116 mg/kg/day based on increased 

testicular softening and atrophy 

Cancer (oral, dermal, inhalation) Classification: No oncogenic potential was noted in the mouse oncogenicity or in the rat combined chronic/ 

carcinogenicity studies; additionally, no mutagenic potential was noted in any of the five mutagenicity 

studies. Classification of kasugamycin is ‘‘not likely to be carcinogenic to humans.’’

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. This final rule reflects the 

establishment of the first tolerance for 

kasugamycin. Since there are no 

registered uses in the United States, the 

only exposure expected is from 

imported foods. Risk assessments were 

conducted by EPA to assess dietary 

exposures from kasugamycin 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 kasugamycin; 

therefore, a quantitative acute dietary 

exposure assessment is unnecessary. No 

appropriate dose or endpoint could be 

identified for acute dietary exposure in 

the general population or any 

population subgroup. 

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), 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: The 

analysis is based on tolerance-level 

residues (modified by DEEM default 

processing factors for tomato processed 

commodities) and the assumption that 

100% of the crop will be treated. 

iii. Cancer. The Agency classified 

kasugamycin as ‘‘not likely to be 

carcinogenic to humans,’’ based on the 

lack of evidence of carcinogenicity in 

mice and rats. Therefore, a quantitative 

cancer exposure assessment was not 

conducted. 

2. Dietary exposure from drinking 

water. There is no expectation that 

kasugamycin residues would occur in 

surface or ground water sources of 

drinking water. There are no registered 

uses of kasugamycin in the United 

States. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonVerDate Aug<31>2005 14:48 Sep 22, 2005 Jkt 205001 PO 00000 Frm 00045 Fmt 4700 Sfmt 4700 E:\FR\FM\23SER1.SGM 23SER1
55750 Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 

occupational, non-dietary exposure 

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

indoor pest control, termiticides, and 

flea and tick control on pets). 

Kasugamycin 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 

kasugamycin and any other substances 

and kasugamycin 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 kasugamycin 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 margin of exposure 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. 

No increased quantitative or qualitative 

susceptibility was observed in the 

developmental rat or rabbit studies or in 

the 2–generation reproduction study. No 

offspring toxicity was observed at any of 

the doses tested in these three studies. 

Reproductive toxicity was noted in the 

F1 generation of the 2–generation 

reproduction study. However, because 

parental toxicity (decreased body 

weights and body weight gains) occured 

at a lower dose than that which resulted 

in effects on reproduction, there is no 

increased quantitative or qualitative 

susceptibility of the offspring. The 

toxicology database for kasugamycin is 

complete with respect to prenatal and 

postnatal toxicity and shows no 

evidence of increased qualitative or 

quantitative susceptibility in the 

offspring. Therefore, there are no 

residual uncertainties for prenatal and/ 

or postnatal toxicity. 

3. Conclusion. There is a complete 

toxicity data base for kasugamycin and 

exposure data are complete or are 

estimated based on data that reasonably 

accounts for potential exposures. 

Additionally, a developmental 

neurotoxicity study is not required 

because there was no evidence of 

neurotoxicity in any studies. Based on 

the above information, EPA concludes 

that it has reliable data that supports the 

conclusion that it is safe to remove the 

additional children’s safety factor. 

E. Aggregate Risks and Determination of 

Safety 

1. Acute risk. No appropriate dose or 

endpoint was identified for acute 

dietary exposure in the general 

population or any population subgroup. 

Therefore, no acute risk is expected 

from exposure to Kasugamycin. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to kasugamycin from food 

will utilize < 1% of the cPAD for the 

U.S. population, < 1% of the cPAD for 

all infants < 1–year, and < 1% of the 

cPAD for children 1-2 years. There are 

no residential uses for kasugamycin that 

result in chronic residential exposure to 

kasugamycin, and no exposure is 

expected from drinking water. EPA does 

not expect the aggregate exposure 

(dietary only) to exceed 100% of the 

cPAD as shown in Table 2 of this unit. 

TABLE 2.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) 

EXPOSURE TO KASUGAMYCIN

Population/ 

Subgroup 

cPAD (mg/ 

kg/day 

%cPAD 

(Food) 

U.S. population 0.113 <1 

All Infants (< 1 

yr) 0.113 <1 

Children 1-2 

yrs 0.113 <1 

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.) 

Kasugamycin is not registered for use 

on any sites that would result in 

residential exposure, and the tolerance 

in this rule is for imported fruiting 

vegetables (crop group 8). No exposure 

is expected from drinking water. 

Therefore, the aggregate risk is from 

food only, and which does not exceed 

the Agency’s level of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). 

Kasugamycin is not registered for use 

on any sites that would result in 

residential exposure, and the tolerance 

in this rule is for imported fruiting 

vegetables (crop group 8). No exposure 

is expected from drinking water. 

Therefore, the aggregate risk is from 

food only, and which does not exceed 

the Agency’s level of concern. 

5. Aggregate cancer risk for U.S. 

population. Kasugamycin has not been 

shown to be carcinogenic. Therefore, 

kasugamycin is not expected to pose a 

cancer risk. 

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 kasugamycin 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

The analytical enforcement method 

uses ion exchange resins for clean up 

and reverse-phase ion-pairing liquid 

chromatography with ultra-violet 

detection (HPLC/UV). This method was 

validated by an independent laboratory. 

The Agency’s laboratory also conducted 

a laboratory trial of this method and has 

determined the method performance to 

Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 55751 

be useful as an enforcement method 

with the incorporated revisions 

recommended by the petitioner. 

The method (HPLC/UV) 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 MRLs for 

kasugamycin. 

C. Response to Comments 

Comments were received from a 

private citizen on the notice of filing for 

kasugamycin on April 17, 2005 

objecting to this proposed tolerance. 

The comments further stated that not 

enough tests have been completed (long 

term or tests on how it combines) and 

that there is little indication of safety. 

The Agency response is as follows: 

The Agency has a complete toxicity 

database on kasugamycin, including 

several long-term or chronic studies. 

Further, EPA has not made a common 

mechanism of toxicity finding as to 

kasugamycin and any other substances 

and kasugamycin does not appear to 

produce a toxic metabolite produced by 

other substances. The commenter 

submitted no scientific information or 

contention in support of the 

commenter’s claims. 

V. Conclusion 

Therefore, the tolerance is established 

for residues of kasugamycin, [3-O-[2- 

amino-4-[(carboxyiminomethyl)amino]- 

2,3,4,6-tetradeoxy-a-D-arabinohexopyranosyl]-D-chiro-inositol]], in or 

on fruiting vegetables (Crop Group 8) at 

0.04 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–2005–0017 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 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–2005–0017, to: Public Information 

and Records Integrity Branch, 

Information Technology and Resource 

Management 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 e-mail to: opp-docket@epa.gov. 

Please use an ASCII file format and 

avoid the use of special characters and 

any form of encryption. Copies of 

electronic objections and hearing 

requests will also be accepted on disks 

in WordPerfect 6.1/8.0 or ASCII file 

format. Do not include any CBI in your 

electronic copy. You may also submit an 

electronic copy of your request at many 

Federal Depository Libraries. 

B. When Will the Agency Grant a 

Request for a Hearing? 

A request for a hearing will be granted 

if the Administrator determines that the 

material submitted shows the following: 

There is a genuine and substantial issue 

of fact; there is a reasonable possibility 

that available evidence identified by the 

requestor would, if established resolve 

one or more of such issues in favor of 

the requestor, taking into account 

uncontested claims or facts to the 

contrary; and resolution of the factual 

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, 

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.