65850 Federal Register / Vol. 66, No. 246 / Friday, December 21, 2001 / Rules and Regulations

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, 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. Submission to Congress and the

Comptroller General

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 record keeping

requirements.

Dated: December 8, 2001.

Peter Caulkins,

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), 346(a) and

371.

2. Section 180.551 is amended by

alphabetically adding commodities to

the table in paragraph (a) to read as

follows:

§ 180.551 Fluthiacet-methyl; tolerances for

residues.

(a) General. * * *

Commodity Parts per million

Corn, field, forage 0.050

Corn, field, grain 0.010

Corn, field, stover 0.050

Corn, pop, grain 0.010

Corn, pop, stover 0.050

Corn, sweet, forage 0.050

Corn, sweet, (K +

CWHR)

0.010

Corn, sweet, stover 0.050

*****

* * * * *

[FR Doc. 01–31497 Filed 12–20–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301196; FRL–6811–6]

RIN 2070–AB78

Sodium thiosulfate; 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 sodium

thiosulfate when used as an inert

ingredient (dechlorinator) in or on

growing crops, or when applied to raw

agricultural commodities after harvest.

Eden Bioscience submitted a petition to

EPA under the Federal Food, Drug, and

Cosmetic Act, as amended by the Food

Quality Protection Act of 1996

requesting an 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

December 21, 2001. Objections and

requests for hearings, identified by

docket control number OPP–301196,

must be received by EPA on or before

February 19, 2002.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, in person, or by courier. Please

follow the detailed instructions for each

method as provided in Unit VIII. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301196 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Kathryn Boyle, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 305–6304; and e-mail

address: boyle.kathryn@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer, or pesticide

manufacturer. Potentially affected

categories and entities may include, but

are not limited to:

Categories NAICS

codes

Examples of potentially affected entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

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 the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations,’’ ‘‘Regulations

and Proposed Rules,’’ and then look up

the entry for this document under the

‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/. A frequently

updated electronic version of 40 CFR

Federal Register / Vol. 66, No. 246 / Friday, December 21, 2001 / Rules and Regulations 65851

part 180 is available at http://

www.access.gpo.gov/nara/cfr/

cfrhtml_00/Title_40/40cfr180_00.html, a

beta site currently under development.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–301196. The official record

consists of the documents specifically

referenced in this action, and other

information related to this action,

including any information claimed as

Confidential Business Information (CBI).

This official record includes the

documents that are physically located in

the docket, as well as the documents

that are referenced in those documents.

The public version of the official record

does not include any information

claimed as CBI. The public version of

the official record, which includes

printed, paper versions of any electronic

comments submitted during an

applicable comment period is available

for inspection in the Public Information

and Records Integrity Branch (PIRIB),

Rm. 119, Crystal Mall #2, 1921 Jefferson

Davis Hwy., Arlington, VA, from 8:30

a.m. to 4 p.m., Monday through Friday,

excluding legal holidays. The PIRIB

telephone number is (703) 305–5805.

II. Background and Statutory Findings

In the Federal Register of September

6, 2000 (65 FR 54015) (FRL–6738–4),

EPA issued a notice pursuant to section

408 of the Federal Food, Drug, and

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

as amended by the Food Quality

Protection Act (FQPA) (Public Law 104–

170) announcing the filing of a pesticide

petition (PP 0E6177) by Eden

Bioscience, 11816 Creek Parkway North,

Bothell, Washington, 98011–8205. This

notice included a summary prepared by

the petitioner. There were no comments

received in response to the notice of

filing.

The petition requested that 40 CFR

180.1001(c) be amended by establishing

an exemption from the requirement of a

tolerance for residues of sodium

thiosulfate penthydrate (CAS Reg. No.

10102–17–7). The petition requested

only the use of sodium thiosulfate

pentahydrate; however, sodium

thiosulfate is also available in an

anhydrous form. The two chemical

substances differ only in the attachment

of the water molecules. The petition

specified that sodium thiosulfate should

be used at a concentration of 1 to 6%

of the formulated product.

The sodium thiosulfate will be used

as a pretreatment for the water in tank

mixes to remove chlorine or other

reactant species, thus functioning as a

dechlorinator or reducing agent. When

mixed with chlorine-containing water,

sodium thiosulfate reacts with the

chlorine according to the equation

Na2S2O3 + 4Cl2 + 5H2O ‰ 2NaHSO4 +

8HCl. Sodium thiosulfate also reacts

with hydrochloric acid (produced in the

previous reaction) to form breakdown

products such as sulfur, salt and water:

Na2S2O3 + 2HCl ‰ 2NaCl + H2O + S +

SO2.

Section 408(b)(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(b)(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. Section

408(b)(2)(C) 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. Inert Ingredient Definition

Inert ingredients are all ingredients

that are not active ingredients as defined

in 40 CFR 153.125 and include, but are

not limited to, the following types of

ingredients (except when they have a

pesticidal efficacy of their own):

Solvents such as alcohols and

hydrocarbons; surfactants such as

polyoxyethylene polymers and fatty

acids; carriers such as clay and

diatomaceous earth; thickeners such as

carrageenan and modified cellulose;

wetting, spreading, and dispersing

agents; propellants in aerosol

dispensers; microencapsulating agents;

and emulsifiers. The term ‘‘inert’’ is not

intended to imply nontoxicity; the

ingredient may or may not be

chemically active. Generally, EPA has

exempted inert ingredients from the

requirement of a tolerance based on the

low toxicity of the individual inert

ingredients.

IV. 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. The information submitted in

support of this petition included

portions of the Food and Drug

Administration (FDA) generally

recognized as safe (GRAS)

determination (‘‘Evaluation of the

Health Aspects of Sodium Thiosulfate

as a Food Ingredient’’), articles from

open literature, and an acute oral

toxicity study.

A. Medical Uses

There are medical uses of sodium

thiosulfate. It has been used as an

antidote for acute cyanide poisoning

(intravenous injection), and is an

ingredient in various dermally-applied

lotion formulations used to treat acne

and ringworm.

B. GRAS Determination

Sodium thiosulfate pentahydrate has

been classified as GRAS by the FDA

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%). A GRAS

determination means general

recognition of safety by experts

qualified by scientific training and

experience to evaluate the safety of the

substance for the specified use pattern.

As noted by the limitations stated

above, sodium thiosulfate has a very

limited use pattern. EPA will use the

information evaluated as part of the

FDA GRAS determination to inform the

Agency’s decision.

In its 1975 Evaluation, FDA reported

the following information on the

sodium thiosulfate absorption and

metabolism: Sodium thiosulfate is a

normal constituent of human body

fluids and is excreted in the urine of

man and higher animals. Quantitative

studies have demonstrated the

consistent presence of 2 to 17

milligrams (mg) of thiosulfate sulfur in

24-hour urine specimens of healthy

young adults. Variations in excretion of

thiosulfate are related to the extent of

protein metabolism, activity of the

intestinal flora, and the sulfur-amino

65852 Federal Register / Vol. 66, No. 246 / Friday, December 21, 2001 / Rules and Regulations

acid content of the diet. The sulfurcontaining amino acids of dietary

protein are the source of the endogenous

thiosulfate pool. Orally administered

thiosulfate that is absorbed from the

gastrointestinal tract is excreted in the

urine unchanged or after oxidation to

sulfate. From 5 to 70% of an oral dose

of sodium thiosulfate is considered to be

absorbed from the gastrointestinal tract

of man and the remainder to be excreted

in the feces.

According to the Evaluation, sodium

thiosulfate was found to cause no

mutagenic effects.

The Evaluation also included a

summary of the results of

developmental studies on rats, mice,

and hamsters. It was determined there

was no effect on nidation, maternal or

fetal survival, or fetal development.

C. Open Literature Articles

Three of the articles from open

literature were reviewed to determine if

the articles could supply information to

the Agency on the genotoxicity of

sodium thiosulfate. There is no

indication of any mutagenic activity

associated with exposure to sodium

thiosulfate.

D. Acute Oral Toxicity Study

An acute oral toxicity study in the rat

performed with sodium thiosulfate

pentahydrate was submitted. The study

was classified as acceptable, toxicity

category IV. The LD50 is greater than

5,050 milligrams/kilograms (mg/kg)

(males and females combined).

E. Developmental Toxicity

As part of the information submitted

in support of the petition, the petitioner

submitted the final reports for the rat,

mouse, and hamster developmental

studies that were discussed in the FDA

Evaluation (dated 1972), as well as the

final report for a rabbit developmental

toxicity study (dated 1974). These

studies were performed using the

anhydrous form of sodium thiosulfate.

Due to the passage of almost 30 years,

as well as the changes in laboratory

techniques that have occurred during

this time, the data tables in the reports

were reviewed to determine if any

additional information were contained

in the tables.

1.Mouse. Animals were tested at the

following dose levels: Negative control,

positive control, 5.5, 25.5, 118 or 550

mg/kg/day over a 10–day period from

day 6 through day 15 of gestation. There

was no indication of any effect on

maternal or fetal survival, or in

incidences of visceral or skeletal

abnormalities. The male/female ratio of

the fetuses were calculated to be,

respectively, 1.08, 0.93, 0.74, 0.90, 0.88,

or 0.68. The ratios at the lowest and

highest dose levels are lower than the

other ratios.

2. Rat. Animals were tested at the

following dose levels: Negative control,

positive control, 4.0, 19.0, 86.0, or 400

mg/kg/day over a 10–day period from

day 6 through day 15 of gestation. There

was no indication of any effect on

maternal or fetal survival, or in

incidences of visceral or skeletal

abnormalities. The male/female ratio of

the fetuses were calculated to be,

respectively, 0.84, 0.78, 0.84, 0.98, 0.92,

or 0.73. There is an indication of

skewing (a lowering) in these ratios at

the highest dose level and in the

positive control.

3.Hamster. Animals were tested at the

following dose levels: negative control,

positive control, 4.0, 19.0, 86.0, or 400

mg/kg/day over a 5–day period from day

6 through day 10 of gestation. There was

no indication of any effect on maternal

or fetal survival, or in incidences of

visceral or skeletal abnormalities. The

male/female ratio of the fetuses were

calculated to be, respectively, 0.52, 0.54,

0.59, 0.47, 0.40, or 0.53. These ratios

(including those from the controls) are

very unusual.

4. Rabbit. The results of the rabbit

developmental study were not

considered in the FDA Evaluation.

Animals were tested over a 13–day

period from day 6 through day 18 of

gestation. There was no indication of

any effect on maternal or fetal survival,

or in incidences of visceral or skeletal

abnormalities at the highest dose level

of 580 mg/kg/day. There was no

indication of any effect on the male/

female ratio of the fetuses since the ratio

ranged from 1.13 to 1.26.

F. Information from the Internet

To ascertain whether additional

information on sodium thiosulfate were

available, the Agency also searched the

Tox Net website at the National Library

of Medicine (http://

www.toxnet.nlm.nih.gov). This website

contained only information on sodium

thiosulfate anhydrous (CAS. Reg. No.

7772–98–7). The Tox Net website

classified sodium thiosulfate as

moderately toxic, and generally

supported the information presented in

the petition. The excerpts and

summaries indicated that sodium

thiosulfate is not mutagenic.No internet

information indicated concerns for

carcinogenicity or developmental/

reproductive toxicity. One study which

investigated the ability of sodium

thiosulfate to cross the placenta in

sheep, concluded that maternallyadministered sodium thiosulfate (50

mg/kg) does not increase fetal plasma

thiosulfate concentrations. No

information on sodium thiosulfate was

available on the National Toxicology

Program website, the Agency for Toxic

Substances and Disease Registry

website, or the Agency’s Integrated Risk

Information System website. The

TSCATs database (http://esc.syrres.com/

efdb/TSCATS.htm) did not contain any

summaries of any developmental or

reproductive studies conducted with

sodium thiosulfate.

G. Toxicity of Sodium Thiosulfate

Overall, sodium thiosulfate presents

as a chemical with slight to moderate

toxicity. It is Category IV for acute oral

toxicity (the lowest classification), and

there are no indications of mutagenicity.

The available developmental data

indicates no effect on maternal or fetal

survival or increase in incidences of

visceral or skeletal abnormalities. The

sex ratios (the male/female ratio of the

fetuses) should cluster close to 1,

indicating equal numbers of males and

females. This is evident in the range of

ratios in the rabbit study. However, the

Agency’s re-evaluation of the summary

data for the rat and mouse

developmental data (two out of four

species) suggest the possibility that

various doses of sodium thiosulfate may

be associated with an apparent skewing

(a lowering) of the sex ratio. However,

it was also most unusual that this

skewing occurred not only for certain

dose levels, but also for a positive

control. The sex ratios for the hamster

are very unusual. Therefore, there is an

uncertainty as to what these ratios

mean. But, there is the possibility of

technician error in sex identification. In

the three studies included in the FDA

Evaluation (rat, mice, and hamster), the

description of the studies included the

following: All fetuses were examined

grossly for the presence of external

congenital abnormalities. One-third of

the fetuses of each litter underwent

detailed visceral examinations

employing 10X magnification. ‘‘The

remaining two-thirds were cleared and

examined for skeletal defects.’’ Thus,

there was no chance to correct any missexing. The rabbit study, in which there

was no effect on the male/female ratio

of the fetuses, was performed in a

different manner: ‘‘All fetuses

underwent a detailed gross examination

for the presence of external congenital

abnormalities.’’ All were examined for

visceral abnormalities. ‘‘All fetuses were

then cleared and examined for skeletal

defects.’’ Thus, the examination of all

fetuses apparently allowed for greater

accuracy in sexing.

Federal Register / Vol. 66, No. 246 / Friday, December 21, 2001 / Rules and Regulations 65853

V. 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 establishes exemptions from the

requirement of a tolerance only in those

cases where the risks from aggregate

exposure to pesticide chemical residues

under reasonably foreseeable

circumstances will pose no appreciable

risks to human health. In order to

determine the risks from aggregate

exposure to pesticide inert ingredients,

the Agency considers the toxicity of the

inert in conjunction with possible

exposure to residues of the inert

ingredient through food, drinking water,

and through other exposures that occur

as a result of pesticide use in residential

settings. If EPA is able to determine that

a finite tolerance is not necessary to

ensure that there is a reasonable

certainty that no harm will result from

aggregate exposure to the inert

ingredient, an exemption from the

requirement of a tolerance may be

established.

A. Dietary Exposure

For the purposes of assessing

potential exposure under this

exemption, EPA considered that sodium

thiosulfate could be present in all raw

and processed agricultural commodities

and drinking water, and that nonoccupational non-dietary exposure was

possible.

1. Food. Protein, which is composed

of various amino acids, is required for

human survival. Sodium thiosulfate is

produced in the human body during the

metabolism of sulfur-containing amino

acids. There is an effective selfregulating mechanism to rid the body of

excess sodium thiosulfate through

excretion in the urine. As previously

stated, sodium thiosulfate is considered

to be GRAS for a very specific use

pattern. In the 1975 Evaluation, it was

estimated that the per capita

consumption of sodium thiosulfate was

12 micrograms (μg) per day. Considering

the use of sodium thiosulfate in

pesticide products, as a dechlorinator

when mixed with certain proteins such

as harpin protein, and given the reactive

nature (as a reducing agent) of sodium

thiosulfate, this use pattern should not

significantly increase the amount of

sodium thiosulfate in the food supply

above those amounts permitted by FDA.

2. Drinking water exposure.

Thiosulfate can be produced naturally

by the reaction of elemental sulfur with

sulfite ion in boiling water. Therefore,

thiosulfate occurs naturally in such

environments as hot springs, geysers,

and marine hydrothermal vents. It can

also occur in nature as the result of the

biological or chemical oxidation of

sulfide, and thus can be found in

freshwater and marine sediments, and

salt marshes.

Considering that thiosulfate can be

metabolized by sulfate-reducing

bacteria, and given its ability to react

with chlorine (to act as a reducing

agent), sodium thiosulfate is unlikely to

occur in drinking water.

B. Other Non-Occupational Exposure

The medicinal uses of sodium

thiosulfate are also regulated by FDA.

There are other industrial uses of

sodium thiosulfate which include use as

a photographic fixing agent. Sodium

thiosulfate is also used to remove

chlorine from water used in aquariums.

C. Exposure Estimates

As previously stated, it was estimated

that the per capita consumption of

sodium thiosulfate was 12 μg per day.

This was based on the amount of

sodium thiosulfate used by the food

industry and assuming a population of

210 million. (The Agency acknowledges

that this exposure estimate is almost 30

years old.) If this were converted to mg/

kg/day using a 60 kg (female) body

weight, then the exposure could be

estimated as 0.0002 mg/kg/day. The

highest dose levels in each of the

developmental toxicity studies (mouse,

rat, hamster, and rabbit) were

respectively 550, 400, 400, and 580 mg/

kg/day. No effects were noted at these

levels. The Agency has not attempted to

use a safety factor analysis for sodium

thiosulfate; however, the 0.0002 mg/kg/

day is orders of magnitude lower than

the highest dose levels from any of the

developmental toxicity studies. Thus,

the reported uses of sodium thiosulfate,

its use as a GRAS substance and its use

as an inert ingredient (a dechlorinator)

should result in human exposure far

below any dose level that could possibly

produce an adverse effect.

VI. Cumulative Effects

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

requires that, when considering whether

to establish, modify, or revoke a

tolerance or tolerance exemption, the

Agency consider ‘‘available

information’’ concerning the cumulative

effects of a particular chemical’s

residues and ‘‘other substances that

have a common mechanism of toxicity.’’

Sodium thiosulfate is produced in the

human body during the metabolism of

sulfur-containing amino acids. There is

an effective self-regulating mechanism

(excretion) to rid the body of excess

sodium thiosulfate, so cumulative

effects are unlikely as a result of

exposure to sodium thiosulfate and a

substance sharing a common

mechanism of toxicity, assuming such a

substance exists. The Agency has not

made any conclusions as to whether or

not sodium thiosulfate shares a common

mechanism of toxicity with any other

chemicals, since cumulative effects for

sodium thiosulfate and other substances

are unlikely.

VII. Determination of Safety for U.S.

Population

Based on the low-moderate toxicity of

sodium thiosulfate and the low

potential for exposure from the EPA

regulated uses of sodium thiosulfate, as

well as the FDA GRAS uses, the Agency

has determined that aggregate exposure

to sodium thiosulfate under reasonably

foreseeable circumstances will pose no

appreciable risks to human health.

Accordingly, EPA concludes that there

is a reasonable certainty of no harm to

the U.S. population from aggregate

exposure to residues of sodium

thiosulfate and that a tolerance is not

necessary.

VIII. Determination of Safety for Infants

and Children

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 base unless

EPA concludes that a different margin of

safety will be safe for infants and

children. Due to the expected low

toxicity of sodium thiosulfate, EPA has

not used a safety factor analysis to

assess the risk. For the same reasons the

additional tenfold safety factor is

unnecessary. The Agency has

determined that there is a reasonable

certainty of no harm to infants and

children from aggregate exposure to

residues of sodium thiosulfate and that

a tolerance is not necessary.

IX. 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

65854 Federal Register / Vol. 66, No. 246 / Friday, December 21, 2001 / Rules and Regulations

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 sodium thiosulfate for

endocrine effects may be required.

B. Analytical Method(s)

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 Exemptions

There are no existing exemptions for

sodium thiosulfate anhydrous or

sodium thiosulfate pentahydrate.

D. International Tolerances

The Agency is not aware of any

country requiring a tolerance for sodium

thiosulfate anhydrous or sodium

thiosulfate pentahydrate nor have any

CODEX Maximum Residue Levels

(MRLs) been established for any food

crops at this time.

X. Conclusions

Based on the information in this

preamble, EPA concludes that there is a

reasonable certainty of no harm from

aggregate exposure to residues of

sodium thiosulfate anhydrous or

sodium thiosulfate pentahydrate.

Accordingly, EPA finds that exempting

sodium thiosulfate anhydrous or

sodium thiosulfate pentahydrate from

the requirement of a tolerance will be

safe.

XI. 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

accordance with the instructions

provided in this unit and in 40 CFR part

178. To ensure proper receipt by EPA,

you must identify docket control

number OPP–301196 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 February 19, 2002.

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 (1900), Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460. You

may also deliver your request to the

Office of the Hearing Clerk in Rm. C400,

Waterside Mall, 401 M St., SW.,

Washington, DC 20460. 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) 260–4865.

2. Tolerance fee payment. If you file

an objection or request a hearing, you

must also pay the fee prescribed by 40

CFR 180.33(i) or request a waiver of that

fee pursuant to 40 CFR 180.33(m). You

must mail the fee to: EPA Headquarters

Accounting Operations Branch, Office

of Pesticide Programs, P.O. Box

360277M, Pittsburgh, PA 15251. Please

identify the fee submission by labeling

it ‘‘Tolerance Petition Fees.’’

EPA is authorized to waive any fee

requirement ‘‘when in the judgement of

the Administrator such a waiver or

refund is equitable and not contrary to

the purpose of this subsection.’’ For

additional information regarding the

waiver of these fees, you may contact

James Tompkins by phone at (703) 305–

5697, by e-mail at

tompkins.jim@epa.gov, or by mailing a

request for information to Mr. Tompkins

at Registration Division (7505C), Office

of Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

If you would like to request a waiver

of the tolerance objection fees, you must

mail your request for such a waiver to:

James Hollins, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

3. 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 Unit I.B.2. Mail your

copies, identified by docket control

number OPP–301196, 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 Unit

I.B.2. 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).

XII. Regulatory Assessment

Requirements

This final rule establishes an

exemption from the tolerance

Federal Register / Vol. 66, No. 246 / Friday, December 21, 2001 / Rules and Regulations 65855

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,

entitledFederalism (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

responsibilities between the Federal

government and Indian tribes, as

specified in Executive Order 13175.

Thus, Executive Order 13175 does not

apply to this rule.

XIII. Submission to Congress and the

Comptroller General

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: December 6, 2001.

Peter Caulkins,

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), 346(a) and

371.

2. In § 180.1001, the table in

paragraph (c) is amended by adding

alphabetically the following inert

ingredient to read as follows:

§ 180.1001 Exemptions from the

requirement of a tolerance.

* * * * *

(c) * * *

Inert ingredients Limits Uses

*******

Sodium thiosulfate anhydrous (CAS Reg. No.7772–98–7 or

sodium thiosulfate pentahydrate,CAS Reg. No. 10102–17–7)

Not to exceed 6% of theformulated

product

Dechlorinator, reducing agent

*******

65856 Federal Register / Vol. 66, No. 246 / Friday, December 21, 2001 / Rules and Regulations

* * * * *

[FR Doc. 01–31496 Filed 12–20–01; 8:45 am]

BILLING CODE 6560–50–S

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 36

Federal-State Joint Board on Universal

Service

AGENCY: Federal Communications

Commission.

ACTION: Correcting amendment.

SUMMARY: This document contains

corrections to the final regulations in

the Fourteenth Report and Order, which

were published in the Federal Register

of Tuesday, June 5, 2001, 66 FR 30080.

Specifically, this correction revises the

language in section 36.605(c)(3)(ii) to

make it clear.

DATES: Effective January 22, 2002.

FOR FURTHER INFORMATION CONTACT: Greg

Guice, Attorney, Common Carrier

Bureau, Accounting Policy Division,

(202) 418–0095.

SUPPLEMENTARY INFORMATION: This is a

summary of the Commission’s TwentyThird Order on Reconsideration in CC

Docket No. 96–45 released on July 11,

2001. The full text of this document is

available for public inspection during

regular business hours in the FCC

Reference Center, Room CY–A257, 445

Twelfth Street, S.W., Washington, D.C.,

20554.

I. Introduction

1. In this document, the Commission

makes a correction to section

36.605(c)(3)(ii) of its rules adopted in

the Fourteenth Report and Order, 66 FR

30080, June 5, 2001. The correction

concerns the calculation of safety net

additive support in the years following

qualification for such support and is

necessary to make the rule consistent

with the text of the underlying order.

Specifically, this correction revises the

language in section 36.605(c)(3)(ii) to

make it clear that rural telephone

companies receive the lesser of either:

(1) the sum of capped support and the

safety net additive support in each year

or (2) uncapped support in each year

when the cap is not triggered.

Need for Correction

As published, the final regulations

contain errors which may prove to be

misleading and need to be clarified.

List of Subjects in 47 CFR Part 36

Communications common carriers,

Telephone.

Federal Communications Commission.

Magalie Roman Salas,

Secretary.

Accordingly, 47 CFR part 36 is

corrected by making the following

correcting amendment:

PART 36—JURISDICTIONAL

SEPARATIONS

1. The authority citation for part 36

continues to read as follows:

Authority: 47 U.S.C. §§ 151–154, 201–205,

218–220, 254, 303(r), 403, 405, and 410.

2. Section 36.605(c)(3)(ii) is revised to

read as follows:

§ 36.605 Calculation of safety net additive.

* * * * *

(c) * * *

(3) * * *

(ii) Continue to pay safety net additive

support in any of the four succeeding

years in which the total carrier loop

expense adjustment is limited by the

provisions of § 36.603. Safety net

additive support in the succeeding four

years shall be the lesser of:

(A) The sum of capped support and

the safety net additive support received

in the qualifying year;

or

(B) The rural telephone company’s

uncapped support.

* * * * *

[FR Doc. 01–31364 Filed 12–20–01; 8:45 am]

BILLING CODE 6712–01–P

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 54

[CC Docket No. 96–45; FCC 01–321]

Federal-State Joint Board on Universal

Service; Petition for Reconsideration

Filed by the United States Telecom

Association

AGENCY: Federal Communications

Commission.

ACTION: Final rule, denial.

SUMMARY: In this document, the

Commission denies the request of the

United States Telecom Association to

reconsider portions of the Contribution

Interval Order modifying the

methodology used to assess

contributions that carriers make to the

federal universal service support

mechanisms.

FOR FURTHER INFORMATION CONTACT:

Richard D. Smith, Attorney, Common

Carrier Bureau, Accounting Policy

Division, (202) 418–7400.

SUPPLEMENTARY INFORMATION: This is a

summary of the Commission’s Order on

Reconsideration in CC Docket No. 96–45

released on November 6, 2001. The full

text of this document is available for

public inspection during regular

business hours in the FCC Reference

Center, Room CY–A257, 445 Twelfth

Street, S.W., Washington, D.C., 20554.

I. Introduction

1. In this Order on Reconsideration,

we deny the request of the United States

Telecom Association (USTA) to

reconsider portions of the Contribution

Interval Order, 66 FR 16145, March 23,

2001, modifying the methodology used

to assess contributions that carriers

make to the federal universal service

support mechanisms. Specifically, we

deny USTA’s request to reconsider the

imposition of additional filing

requirements and the method of

calculating contributions from carriers

that either under-report or over-report

quarterly revenue. In so doing, we

affirm our prior conclusion that the

provision of sufficient and

competitively neutral funding for the

universal service support mechanisms

depends on the timely submission of

accurate revenue information from

contributors.

II. Discussion

2. We deny the request of USTA to

reconsider portions of the Contribution

Interval Order. We find that USTA has

raised no new issues or facts to

persuade us to reconsider the decisions

made in the Contribution Interval Order.

Specifically, we conclude that the

accurate submission of quarterly

revenue data is essential to ensure that

sufficient contributions are made to the

federal universal service support

mechanisms on a competitively neutral

basis. The Commission carefully

considered the implications of imposing

additional reporting requirements on

carriers in the Contribution Interval

Order and concluded that such

requirements were necessary. In

addition, we conclude that the method

adopted by the Commission of

calculating contributions from carriers

that under-report or over-report

revenues provides an appropriate

incentive for carriers to accurately

report quarterly revenues to USAC.

3. Reporting Requirements. We deny

USTA’s request to reconsider the

Commission’s decision to increase

carriers’ reporting requirements. USTA’s

petition raises no new arguments that

would convince us to reconsider the

conclusion that the benefits of

substantially reducing the contribution

interval outweigh any increased