58310 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 

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 the 

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.

IX. 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 24, 2004.

Donald R. Stubbs,

Acting Director, Registration Division, Office 

of Pesticide Programs.

■ Therefore, 40 CFR chapter I is 

amended as follows:

PART 180—[AMENDED]

■ 1. The authority citation for part 180 

continues to read as follows:

Authority: 21 U.S.C. 321(q), 346a and 371.

■ 2. Section 180.571 is amended by 

alphabetically adding an entry for 

‘‘Cranberry’’ to the table in paragraph (b) 

to read as follows:

§ 180.571 Mesotrione; tolerances for 

residues.

* * * * *

(b) * * *

Commodity Parts per million Expiration/revocation date 

** * **

Cranberry ..................................................................................................................................................... 0.01 12/31/07

* * * * *

[FR Doc. 04–21934 Filed 9–29–04; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0289; FRL–7677–1]

Sodium Thiosulfate; Exemption from 

the Requirement of a Tolerance

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation amends an 

existing exemption from the 

requirement of a tolerance for residues 

of sodium thiosulfate on raw 

agricultural commodities when used in 

pesticide formulations as an inert 

ingredient on raw agricultural 

commodities after harvest. Eden 

Bioscience Corporation 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), requesting an 

unlimited exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of sodium thiosulfate.

DATES: This regulation is effective 

September 30, 2004. Objections and 

requests for hearings must be received 

on or before November 29, 2004.

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit IX. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2004–

0289. 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 South 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:

Princess Campbell, Registration 

Division (7505C), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 308–8033; e-mail address: 

campbell.princess@epa.gov.

Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 58311

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to:

• Crop production (NAICS code 

111),

• Animal production (NAICS code 

112),

• Food manufacturing (NAICS code 

311),

• Pesticide manufacturing (NAICS 

code 32532)

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT.

B. How Can I Access Electronic Copies 

of this Document and Other Related 

Information?

In addition to using EDOCKET (http:/

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

access this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

frequently updated electronic version of 

40 CFR part 180 is available at E-CFR 

Beta Site Two at http://

www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

In response to the original pesticide 

petition (PP OE6177) submitted in 2000 

by Eden Bioscience, EPA established 

tolerance exemptions for sodium 

thiosulfate also known as thiosulfuric 

acid, disodium salt, anhydrous, (CAS 

Reg. No. 7772–98–7) or sodium 

thiosulfate pentahydrate also known as 

thiosulfuric acid disodium salt, 

pentahydrate, (CAS Reg. No. 10102–17–

7). The exemptions as established 

specified that the percent of sodium 

thiosulfate was not to exceed 6% of the 

formulated product. For a discussion of 

the information submitted and the 

results of the Agency’s review and 

evaluation, see the Federal Register of 

December 21, 2001 (66 FR 65850) (FRL–

6811–6).

In the Federal Register of November 

26, 2003 (68 FR 66416) (FRL–7333–8), 

EPA issued a notice pursuant to section 

408(d)(3) of the Federal Food, Drug, and 

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

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

pesticide tolerance petition (PP OE6177) 

by Eden Bioscience, 3830 Monte Villa 

Parkway, Bothell, Washington, 98021–

6942. This notice included a summary 

of the petition prepared by the 

petitioner Eden Bioscience.

The petition requested that the 

existing exemption in 40 CFR 180.1001, 

newly re-designated as 180.910, be 

amended by removing the 6% in the 

formulation limitation for residues of 

sodium thiosulfate (CAS Reg No.10102–

17–7). There were no comments 

received in response to the notice of 

filing.

The petition was amended by Eden 

Bioscience Corporation because recent 

research indicates that higher levels of 

sodium thiosulfate than the currently 

allowed 6% are needed in certain 

situations, such as the use of very high 

water volumes with products containing 

a low percentage of active ingredient. 

Therefore, Eden Bioscience proposed to 

amend the existing exemption to permit 

the use of sodium thiosulfate in a 

pesticide formulated product as an inert 

ingredient with no numerical limitation 

when used on growing crops or on raw 

agricultural commodities after harvest.

Section 408(c)(2)(A)(i) of the FFDCA 

allows EPA to establish an exemption 

from the requirement for 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(c)(2)(A)(ii) 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. Pursuant to 

section 408(c)(2)(B), in establishing or 

maintaining in effect an exemption from 

the requirement of a tolerance, EPA 

must take into account the factors set 

forth in section 408(b)(2)(C), which 

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. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings.

III. Toxicological Profile

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 and considered its validity, 

completeness and reliability and the 

relationship of this information to 

human risk. EPA has also considered 

available information concerning the 

variability of the sensitivities of major 

identifiable subgroups of consumers, 

including infants and children. The 

nature of the toxic effects caused by 

sodium thiosulfate are discussed in this 

unit.

In support of the sodium thiosulfate 

petition submitted in 2000, the 

petitioner submitted mutagenicity 

information obtained from open 

literature, an acute oral toxicity study, 

and FDA’s review and evaluation of the 

developmental studies conducted in the 

mouse, rat, hamster, and rabbit. There 

was no indication of any effect on 

maternal or fetal survival, or in 

incidences of visceral or skeletal 

abnormalities. There was no effect on 

genotoxicity, or mutagenicity for 

sodium thiosulfate. The Agency’s 

review and evaluation of all submitted 

information was cited in the final rule 

published in the Federal Register of 

December 21, 2001, (66 FR 65850). No 

new or additional information was 

submitted to the Agency as a result of 

the amendment to the petition.

IV. Aggregate Exposures

In examining aggregate exposure, 

FFDCA section 408 directs EPA to 

consider available information 

concerning exposures from the pesticide 

residue in food and all other nonoccupational exposures, including 

drinking water from ground water or 

surface water and exposure through 

pesticide use in gardens, lawns, or 

buildings (residential and other indoor 

uses).

EPA evaluated the use of sodium 

thiosulfate as an inert ingredient in 

addition to its use as a GRAS (Generally 

Recognized As Safe) substance as part of 

the previous action. A complete 

discussion on the possible dietary, and 

other non-occupational exposures is 

contained in the final rule published in 

the Federal Register of December 21, 

2001, (66 FR 65850).

58312 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 

In that final rule, EPA considered that 

sodium thiosulfate could be present in 

all raw and processed agricultural 

commodities and drinking water, and 

that non-occupational non-dietary 

exposure was possible.

Sodium thiosulfate is considered to be 

GRAS when used as a formulation aid 

or reducing agent in alcoholic beverages 

(not to exceed 0.00005%) and table salt 

(not to exceed 0.1%), and the per capita 

consumption was estimated to be 12 

micrograms per day based on a 

population of 210 million. This implies 

a dose of 0.0002 milligrams/kilogram/

day (mg/kg/day) for a 60 kg body weight 

female. This dose is orders of magnitude 

lower than the dose levels (550, 400, 

and 580 mg/kg/day) used in the 

developmental toxicity studies which 

were evaluated by the Agency. No 

effects were noted at these levels. The 

use of sodium thiosulfate in pesticide 

products as a dechlorinator when mixed 

with certain proteins such as harpin 

protein (a limited use pattern), and 

especially given the reactive nature of 

sodium thiosulfate, should not 

significantly increase the amount of 

sodium thiosulfate in the food supply 

above the levels that currently exist as 

a result of uses that are regulated by the 

FDA. The final rule of December 21, 

2001 (66 FR 65850), established a 

tolerance exemption for the use of 

sodium thiosulfate as an inert ingredient 

when it constituted no more than 6% of 

the formulation. Thus, the Agency 

concludes that the reported uses of 

sodium thiosulfate, including its use as 

a GRAS substance, and its use as an 

inert ingredient, even without the 6% 

limitation, should result in human 

exposure far below any dose level that 

could possibly produce an adverse 

effect.

V. Cumulative Effects

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 the 

above chemical substances and any 

other substances. Sodium thiosulfate 

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 sodium thiosulfate 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/.

VI. Determination of Safety for U.S. 

Population, Infants and Children

Due to the expected low toxicity of 

sodium thiosulfate, and the low 

potential for exposure, the Agency 

believes that aggregate exposures to 

thiosulfuric acid, disodium salt, 

anhydrous, and thiosulfuric acid, 

disodium salt, pentahydrate under 

reasonably forseeable circumstances 

will pose no appreciable risks to human 

health. FFDCA section 408 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 unless EPA concludes that a 

different margin of safety will be safe for 

infants and children. EPA has not used 

a safety factor analysis to assess the risk. 

For the same reasons a tenfold safety 

factor is unnecessary. Based on the 

information in this preamble, EPA 

concludes that there is a reasonable 

certainty of no harm from aggregate 

exposure to residues of thiosulfuric 

acid, disodium salt, anhydrous (CAS 

Reg. No. 7772–98–7), and thiosulfuric 

acid, disodium salt, pentahydrate (CAS 

Reg. No. 10102–17–7), and that a 

tolerance is not necessary.

VII. Other Considerations

A. Endocrine Disruptors

FQPA requires EPA to develop a 

screening program to determine whether 

certain substances, including all 

pesticide chemicals (both inert and 

active ingredients), may have an effect 

in humans that is similar to an effect 

produced by a naturally occurring 

estrogen, or such other endocrine effect. 

EPA has been working with interested 

stakeholders to develop a screening and 

testing program as well as a priority 

setting scheme. As the Agency proceeds 

with implementation of this program, 

further testing of products containing 

thiosulfuric acid, disodium salt, 

anhydrous, and thiosulfuric acid, 

disodium salt, pentahydrate, for 

endocrine effects may be required.

B. Analytical Method

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation.

C. Existing Tolerances

There is an existing tolerance 

exemption in 40 CFR 180.910 for 

sodium thiosulfate anhydrous, (CAS 

Reg. No. 7772–98–7) or sodium 

thiosulfate pentahydrate, (CAS Reg. No. 

10102–17–7). The Agency is amending 

this tolerance exemption to remove the 

6% in the formulation limitation.

D. International Tolerances

The Agency is not aware of any 

country requiring a tolerance or 

tolerance exemption for sodium 

thiosulfate.

VIII. Conclusions 

Based on this information in the 

record, summarized in this preamble, 

and in the final rule published on 

December 21, 2001 (66 FR 65850), EPA 

concludes that there is reasonable 

certainty of no harm from aggregate 

exposure to residues of sodium 

thiosulfate. Accordingly, EPA finds that 

exempting thiosulfuric acid, disodium 

salt, anhydrous, (CAS Reg. No. 7772–

98–7) or thiosulfuric acid, disodium 

salt, pentahydrate, (CAS Reg. No. 

10102–17–7) from the requirement of a 

tolerance will be safe.

IX. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as 

amended by the 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 the 

FFDCA by the FQPA of 1996, EPA will 

continue to use those procedures, with 

appropriate adjustments, until the 

necessary modifications can be made. 

The new section 408(g) provides 

essentially the same process for persons 

to ‘‘object’’ to a regulation for an 

exemption from the requirement of a 

tolerance issued by EPA under new 

section 408(d), as was provided in the 

old FFDCA sections 408 and 409. 

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 

Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 58313

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–2004–0289 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 29, 2004.

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 VIII.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–2004–0289, to: Public Information 

and Records Integrity Branch, 

Information Resources and Services 

Division (7502C), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460. In person or by 

courier, bring a copy to the location of 

the PIRIB described in ADDRESSES. You 

may also send an electronic copy of 

your request via e-mail to: oppdocket@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).

X. Statutory and Executive Order 

Reviews

This final rule establishes an 

exemption from the tolerance 

requirement under FFDCA section 

408(d) in response to a petition 

submitted to the Agency. The Office of 

Management and Budget (OMB) has 

exempted these types of actions from 

review under Executive Order 12866, 

entitled Regulatory Planning and 

Review (58 FR 51735, October 4, 1993). 

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 FFDCA section 408(d), such as 

the exemption 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 FFDCA section 408(n)(4). 

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 

58314 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule.

XI. 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 24, 2004.

Donald R. Stubbs,

Acting Director, Registration Division, Office 

of Pesticide Programs.

■ Therefore, 40 CFR chapter I is 

amended as follows:

PART 180—[AMENDED]

■ 1. The authority citation for part 180 

continues to read as follows:

Authority: 21 U.S.C. 321(q), 346a and 371.

■ 2. In § 180.910 the table is amended by 

revising the entry for ‘‘sodium 

thiosulfate’’ to read as two separate 

entries and inserting them alphabetically 

as follows:

§ 180.910 Inert ingredients used pre- and 

post-harvest.; exemptions from the 

requirement of a tolerance.

***

Inert Ingredients Limits Uses 

*******

Thiosulfuric acid, disodium salt, anhydrous. (CAS Reg. No 7772–98–7) .......................................... ........................ Dechlorinator, reducing 

agent

Thiosulfuric acid, disodium salt, pentahydrate. (CAS Reg. No. 10102–17–7) ................................... ........................ Dechlorinator, reducing 

agent

*******

[FR Doc. 04–21933 Filed 9–30–04; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0272; FRL–7681–5]

Forchlorfenuron; Pesticide Tolerance

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a 

tolerance for residues of 

forchlorfenuron, N -(2-chloro-4-

pyridinyl)-N′-phenylurea in or on grapes 

and kiwifruit. Siemer & Associates, Inc. 

on behalf of KIM-C1, LLC 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 30, 2004. Objections and 

requests for hearings must be received 

on or before November 29, 2004.

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–2004–

0272. 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:

Dennis McNeilly, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW.,Washington, 

DC 20460–0001; telephone number: 

703–308–6742; e-mail 

address:mcneilly.dennis@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; greehouse, 

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.