Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 55269 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[OPP–2005–0160; FRL–7732–8] 

Cyhexatin; Tolerance Actions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is revoking, under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA) section 408(e)(1), all existing 

tolerances for residues of the 

insecticide/acaricide cyhexatin because 

they do not meet requirements of 

FFDCA section 408(b)(2). EPA canceled 

food use registrations for cyhexatin in 

1989. Currently, EPA determined that 

acute dietary risks from use of cyhexatin 

on commodities for which import 

tolerances exist exceed the Agency’s 

level of concern. However, EPA also 

determined that if the only cyhexatin 

tolerance is for orange juice, there is a 

reasonable certainty that no harm to any 

population subgroup will result from 

exposure to cyhexatin treated oranges. 

Because manufacturers support a 

cyhexatin tolerance on orange juice for 

purposes of importation and the Agency 

has made a determination of safety for 

such a tolerance, EPA is establishing, 

concurrent with the revocation of the 

citrus fruit group tolerance, an 

individual time-limited tolerance on 

orange juice. The regulatory actions in 

this document contribute toward the 

Agency’s tolerance reassessment 

requirements of the FFDCA section 

408(q), as amended by the Food Quality 

Protection Act (FQPA) of 1996. By law, 

EPA is required by August 2006 to 

reassess the tolerances in existence on 

August 2, 1996. The regulatory actions 

in this document pertain to the 

revocation of 41 tolerances which count 

as tolerance reassessments toward the 

August, 2006 review deadline. 

DATES: This regulation is effective 

September 21, 2005. Objections and 

requests for hearings must be received 

on or before November 21, 2005. 

ADDRESSES: To submit a written 

objection or hearing requestfollow the 

detailed instructions as provided in 

Unit IV. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under docket 

identification (ID) number OPP–2005–

0160. 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: 

Joseph Nevola, Special Review and 

Reregistration Division (7508C), Office 

of Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460–

0001; telephone number: (703) 308–

8037; e-mail address: 

nevola.joseph@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/. 

II. Background 

A. What Action is the Agency Taking? 

In the Federal Register of July 27, 

2005 (70 FR 43368) (FRL–7723–5), EPA 

issued a proposed rule to revoke all 

existing tolerances for residues of the 

insecticide/acaricide cyhexatin and 

establish a time-limited tolerance on 

orange juice. Also, the proposal of July 

27, 2005 provided a 30–day comment 

period which invited public comment. 

In response to the proposal published 

in the Federal Register of July 27, 2005 

(70 FR 43368), EPA received two 

comments during the 30–day public 

comment period, as follows: 

Comments by private citizens. A 

private citizen stated opposition to the 

sale and use of cyhexatin, and stated 

that cyhexatin tolerances should not be 

extended for use on any food 

commodity. Another private citizen 

asked whether the final rule actions 

would mean that any amount of 

cyhexatin could be used on imported 

foods. 

Agency response. Recently, EPA 

completed its Tolerance Reassessment 

Eligibility Decision (TRED) for 

cyhexatin. In the Federal Register of July 

13, 2005 (70 FR 40341) (FRL–7720–3), 

EPA published a decision notice for the 

cyhexatin TRED. The TRED and 

documents in support of the TRED are 

available in Edocket ID number OPP–

2004–0295 at http://www.epa.gov/ 

edocket, and at http://www.epa.gov/ 

pesticides/reregistration/status.htm. 

Because there are no active U.S. 

registrations, human exposure to this 

pesticide is strictly through the 

consumption of treated imported foods. 

Residential and occupational exposures 

as well as dietary exposure through 

drinking water are not expected because 

there is no domestic use of cyhexatin. 

Because there have been no active 

U.S. registrations for cyhexatin since 

1989, the comment on its sale and use 

is not relevant to this rulemaking. 

However, cyhexatin tolerances were 

maintained for purposes of importation. 

The commenters did not address EPA’s 

determination that acute dietary 

55270 Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 

exposure estimates for cyhexatin and 

orange juice only are below the 

Agency’s level of concern for all 

population subgroups and that a timelimited import tolerance for orange juice 

should be established. The commenters 

did not refer to any scientific studies or 

specific data that should be considered 

by the Agency. 

EPA determined that acute dietary 

risks from use of cyhexatin on 

commodities for which import 

tolerances exist exceed the Agency’s 

level of concern. Therefore, 

manufacturers had indicated that they 

would support only the import 

tolerances for apple (fresh, juice, sauce, 

and dried) and citrus (orange juice). 

However, the estimated acute dietary 

risks from use of cyhexatin on these 

commodities exceed the Agency’s level 

of concern. The assessment concluded 

that for apples and oranges, the acute 

dietary exposure estimate for children 1- 

2 years of age is at 223% of the acute 

population-adjusted dose (aPAD) at the 

99.9th percentile; for all infants < 1–year 

of age at 187% of the aPAD, and for 

children 3-5 years of age at 151% of the 

aPAD. Apple juice and apple sauces 

were the risk drivers. 

Because of this acute dietary concern, 

manufacturers have withdrawn support 

for cyhexatin tolerances, except for 

orange juice. EPA has evaluated the 

dietary risks from the importation of 

orange juice concentrate to be processed 

into orange juice and has determined 

that there is reasonable certainty that no 

harm to any population subgroup will 

result from exposure to cyhexatin 

treated oranges. The acute dietary 

exposure estimates for orange juice only 

are below the Agency’s level of concern 

for all population subgroups. The most 

highly exposed sub-population was 

children 1-2 years of age, at 35% of the 

aPAD. 

Therefore, EPA is revoking all existing 

tolerances for residues of the 

insecticide/acaricide cyhexatin under 

FFDCA section 408(e)(1) because 

existing tolerances do not meet 

requirements of FFDCA section 

408(b)(2). 

Specifically, EPA is revoking the 

tolerances in 40 CFR 180.144 for 

combined residues of cyhexatin and its 

organotin metabolites (calculated as 

cyhexatin) in or on the following food 

commodities: Almond; almond, hulls; 

apple; cattle, fat; cattle, kidney; cattle, 

liver; cattle, meat byproducts, except 

kidney and liver; cattle, meat; citrus, 

dried pulp; fruit, citrus; goat, fat; goat, 

kidney; goat, liver; goat, meat 

byproducts, except kidney and liver; 

goat, meat; hog, fat; hog, kidney; hog, 

liver; hog, meat byproducts, except 

kidney and liver; hog, meat; hop; hop, 

dried cone; horse, fat; horse, kidney; 

horse, liver; horse, meat byproducts, 

except kidney and liver; horse, meat; 

milk, fat (=N in whole milk); nectarine; 

nut, macadamia; peach; pear; plum, 

prune, dried; plum, prune, fresh; sheep, 

fat; sheep, kidney; sheep, liver; sheep, 

meat byproducts, except kidney and 

liver; sheep, meat; strawberry; and 

walnut. 

However, concurrent with the 

revocation of the crop group tolerance 

on fruit, citrus in 40 CFR 180.144 at 2 

parts per million (ppm), a tolerance on 

orange juice should be established at 0.1 

ppm. Available processing data indicate 

that cyhexatin residues of concern in 

orange juice concentrate were less than 

the limit of quantitation; i.e., less than 

0.1 ppm. Nevertheless, additional 

generic data is needed for EPA to 

confirm processing, analytical method, 

and toxicological data. Under FFDCA 

section 408(f), if the Agency determines 

that additional information is 

reasonably required to support the 

continuation of a tolerance, EPA may 

require that parties interested in 

maintaining the tolerance provide the 

necessary information. Therefore, EPA 

is establishing an individual timelimited tolerance in 40 CFR 180.144 for 

combined residues of cyhexatin and its 

organotin metabolites (calculated as 

cyhexatin) in orange, juice at 0.1 ppm 

with an expiration/revocation date of 

June 13, 2009; i.e., the time-limited 

tolerance will be established for a 

period of 4 years from the TRED 

completion date of June 13, 2005 in 

order to allow sufficient time for the 

Agency to issue a data call-in request, 

the manufacturers to submit the needed 

data, and for the Agency to review it. 

After reviewing the available data, EPA 

will decide whether there is sufficient 

data to support the orange juice 

tolerance as a permanent one. If the 

requisite information is not submitted, 

EPA may issue an order revoking the 

tolerance at issue or allow the timelimited tolerance to expire. 

Without a tolerance or exemption, 

food containing pesticide residues is 

considered to be unsafe and therefore 

‘‘adulterated’’ under section 402(a) of 

the FFDCA (21 U.S.C. 342(a)). Such food 

may not be distributed in interstate 

commerce (21 U.S.C. 331(a)). Food-use 

pesticides not registered in the United 

States must have tolerances in order for 

commodities treated with those 

pesticides to be imported into the 

United States. 

A printed copy of the cyhexatin TRED 

may be obtained from EPA’s National 

Service Center for Environmental 

Publications (EPA/NSCEP), P.O. Box 

42419, Cincinnati, OH 45242–2419, 

telephone 1–800–490–9198; fax 1–513–

489–8695; internet at http:// 

www.epa.gov/ncepihom/ and from the 

National Technical Information Service 

(NTIS), 5285 Port Royal Road, 

Springfield, VA 22161, telephone 1–

800–553–6847 or (703) 605–6000; 

internet at http://www.ntis.gov/. An 

electronic copy of the cyhexatin TRED 

is available on the internet at http:// 

www.epa.gov/pesticides/reregistration/ 

status.htm. 

B. What is the Agency’s Authority for 

Taking this Action? 

EPA’s general practice is to revoke 

tolerances for residues of pesticide 

active ingredients on crops for which 

FIFRA registrations no longer exist and 

on which the pesticide may therefore, 

no longer be used in the United States. 

EPA has historically been concerned 

that retention of tolerances that are not 

necessary to cover residues in or on 

legally treated foods may encourage 

misuse of pesticides within the United 

States. Nonetheless, EPA will establish 

and maintain tolerances even when 

corresponding domestic uses are 

canceled if the tolerances, which EPA 

refers to as ‘‘import tolerances,’’ are 

necessary to allow importation into the 

United States of food containing such 

pesticide residues. However, where 

there are no imported commodities that 

require these import tolerances, the 

Agency believes it is appropriate to 

revoke tolerances for unregistered 

pesticides in order to prevent potential 

misuse. 

C. When Do These Actions Become 

Effective? 

EPA is revoking specific cyhexatin 

tolerances and establishing a timelimited tolerance on orange juice 

effective on the date of publication of 

this final rule in the Federal Register. 

Any commodities listed in the 

regulatory text of this document that are 

treated with the pesticides subject to 

this final rule, and that are in the 

channels of trade following the 

tolerance revocations, shall be subject to 

FFDCA section 408(1)(5), as established 

by the FQPA. Under this section, any 

residues of these pesticides in or on 

such food shall not render the food 

adulterated so long as it is shown to the 

satisfaction of the Food and Drug 

Administration (FDA) that: (1) The 

residue is present as the result of an 

application or use of the pesticide at a 

time and in a manner that was lawful 

under FIFRA, and (2) the residue does 

not exceed the level that was authorized 

at the time of the application or use to 

be present on the food under a tolerance 

Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 55271 

or exemption from tolerance. Evidence 

to show that food was lawfully treated 

may include records that verify the 

dates that the pesticide was applied to 

such food. 

D. What is the Contribution to Tolerance 

Reassessment? 

By law, EPA is required by August 

2006 to reassess the tolerances in 

existence on August 2, 1996. As of 

September 6, 2005, EPA has reassessed 

over 7,430 tolerances. This document 

revokes a total of 41 tolerances which 

are counted as tolerance reassessments 

toward the August 2006 review deadline 

of FFDCA section 408(q), as amended by 

FQPA in 1996. For counting purposes, 

the Agency counts the citrus fruit group 

tolerance as one revocation (where a 

time-limited tolerance on orange juice is 

established in its place). 

III. Are There Any International Trade 

Issues Raised by this Final Action? 

EPA is working to ensure that the U.S. 

tolerance reassessment program under 

FQPA does not disrupt international 

trade. EPA considers Codex Maximum 

Residue Limits (MRLs) in setting U.S. 

tolerances and in reassessing them. 

MRLs are established by the Codex 

Committee on Pesticide Residues, a 

committee within the Codex 

Alimentarius Commission, an 

international organization formed to 

promote the coordination of 

international food standards. When 

possible, EPA seeks to harmonize U.S. 

tolerances with Codex MRLs. EPA may 

establish a tolerance that is different 

from a Codex MRL; however, FFDCA 

section 408(b)(4) requires that EPA 

explain in a Federal Register document 

the reasons for departing from the 

Codex level. EPA’s effort to harmonize 

with Codex MRLs is summarized in the 

tolerance reassessment section of 

individual REDs. EPA has developed 

guidance concerning submissions for 

import tolerance support of June 1, 2000 

(65 FR 35069) (FRL–6559–3). This 

guidance will be made available to 

interested persons. Electronic copies are 

available on the internet at http:// 

www.epa.gov/. On the Home Page select 

‘‘Laws and Regulations,’’ then select 

‘‘Regulations and Proposed Rules’’ and 

then look up the entry for this document 

under ‘‘Federal Register—

Environmental Documents.’’ You can 

also go directly to the ‘‘Federal 

Register’’ listings at http:// 

www.epa.gov/fedrgstr/. 

IV. 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–2005–0160 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 21, 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 issues(s) on which a hearing 

is requested, the requestor’s contentions 

on such issues, and a summary of any 

evidence relied upon by the objector (40 

CFR 178.27). Information submitted in 

connection with an objection or hearing 

request may be claimed confidential by 

marking any part or all of that 

information as CBI. Information so 

marked will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. A copy of the 

information that does not contain CBI 

must be submitted for inclusion in the 

public record. Information not marked 

confidential may be disclosed publicly 

by EPA without prior notice. 

Mail your written request to: Office of 

the Hearing Clerk (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 IV.A.1., 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–2005–0160, to: Public Information 

and Records Integrity Branch, 

Information Resources and Services 

Division (7502C), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001. In person 

or by courier, bring a copy to the 

location of the PIRIB described in 

ADDRESSES. You may also send an 

electronic copy of your request via email to: opp-docket@epa.gov. Please use 

an ASCII file format and avoid the use 

of special characters and any form of 

encryption. Copies of electronic 

objections and hearing requests will also 

be accepted on disks in WordPerfect 

6.1/8.0 or ASCII file format. Do not 

include any CBI in your electronic copy. 

You may also submit an electronic copy 

of your request at many Federal 

Depository Libraries. 

B. When Will the Agency Grant a 

Request for a Hearing? 

A request for a hearing will be granted 

if the Administrator determines that the 

material submitted shows the following: 

There is a genuine and substantial issue 

of fact; there is a reasonable possibility 

that available evidence identified by the 

requestor would, if established resolve 

one or more of such issues in favor of 

the requestor, taking into account 

uncontested claims or facts to the 

contrary; and resolution of the factual 

issues(s) in the manner sought by the 

requestor would be adequate to justify 

the action requested (40 CFR 178.32). 

V. Statutory and Executive Order 

Reviews 

In this final rule EPA revokes specific 

tolerances established under FFDCA 

section 408. The Office of Management 

and Budget (OMB) has exempted this 

type of action (i.e., a tolerance 

revocation for which extraordinary 

circumstances do not exist) 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, 

55272 Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 

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 as required by 

Executive Order 12898, entitled Federal 

Actions to Address Environmental 

Justice in Minority Populations and 

Low-Income Populations (59 FR 7629, 

February 16, 1994); or OMB review or 

any other 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 104–13, section 

12(d) (15 U.S.C. 272 note). Pursuant to 

the Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.), the Agency 

previously assessed whether revocations 

of tolerances might significantly impact 

a substantial number of small entities 

and concluded that, as a general matter, 

these actions do not impose a significant 

economic impact on a substantial 

number of small entities. This analysis 

was published on December 17, 1997 

(62 FR 66020), and was provided to the 

Chief Counsel for Advocacy of the Small 

Business Administration. Taking into 

account this analysis, and available 

information concerning the pesticides 

listed in this rule, the Agency hereby 

certifies that this final rule will not have 

a significant economic impact on a 

substantial number of small entities. 

Specifically, as per the 1997 notice, EPA 

has reviewed its available data on 

imports and foreign pesticide usage and 

concludes that there is a reasonable 

international supply of food not treated 

with canceled pesticides. Furthermore, 

for the pesticides named in this final 

rule, the Agency knows of no 

extraordinary circumstances that exist 

as to the present revocations that would 

change EPA’s previous analysis. 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. 

VI. 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 9, 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 180.144 is amended by 

revising the table under paragraph (a) to 

read as follows: 

§ 180.144 Cyhexatin; tolerances for 

residues. 

(a) General. * * * 

Commodity Parts per 

million 

Expiration/ 

Revocation 

Date 

Orange, juice 0.1 6/13/09 

* * * * * 

[FR Doc. 05–18581 Filed 9–20–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[OPP–2005–0221; FRL–7730–3] 

Reynoutria Sachalinensis Extract; 

Exemption from the Requirement of a 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of the biochemical 

pesticide Reynoutria sachalinensis 

extract on all food commodities. The 

Interregional Research Project Number 4 

(IR-4), on behalf of KHH Bioscience, 

Inc., submitted a petition to EPA under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA), as amended by the Food 

Quality Protection Act of 1996 (FQPA),