22128 Federal Register / Vol. 66, No. 86 / Thursday, May 3, 2001 / Rules and Regulations

TENNESSEE-LEAD

Designated area

Designation Classification

Date Type Date Type

Shelby County (part): Area encompassed by a circle with a 3⁄4 mile radius with center being the

intersection of Castex and Mallory Avenue, Memphis, TN.

July 2, 2001 .................... Attainment ...................... ...........................

*******

[FR Doc. 01–11090 Filed 5–2–01; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301119; FRL–6778–9]

RIN 2070–AB78

Sucroglycerides; 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 sucroglycerides

when used as an inert ingredient in or

on growing crops or when applied to

raw agricultural commodities after

harvest. Rhodia 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 requesting an exemption

from the requirement of a tolerance.

This regulation eliminates the need to

establish a maximum permissible level

for residues of sucroglycerides.

DATES: This regulation is effective May

3, 2001. Objections and requests for

hearings, identified by docket control

number OPP–301119, must be received

by EPA on or before July 2, 2001.

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–301119 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/.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–301119. 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 July 7, 1998

(63 FR 36681) (FRL –5795–6), 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) 6E4714 by Rhodia Inc., CN

7500, Cranbury, NJ 08512–7500. This

notice included a summary of the

petition 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

sucroglycerides.

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.’’

Federal Register / Vol. 66, No. 86 / Thursday, May 3, 2001 / Rules and Regulations 22129

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. Sucroglycerides

Sucroglycerides are a mixture of

substances, primarily of mono-, di-, and

tri-glycerides and mono- and di-sucrose

esters of fatty acids. The product is

produced through a process of

transesterification of an edible fat or oil

with sucrose. Thus, sucroglycerides are

composed of and basically produced

from sugar and oil.

Sucroglycerides have self-affirmed

GRAS (generally recognized as safe)

status. A GRAS substance is one that is

generally recognized, among experts

qualified by scientific training and

experience to evaluate its safety, as

having been adequately shown through

scientific procedures to be safe under

the conditions of its intended use.

Under the FFDCA, there is no

requirement that GRAS status can be

determined only by the Food and Drug

Administration (FDA). The GRAS

determination may also be made by a

company providing that the quantity

and quality of data would be the same

as if the data were submitted to FDA for

review and evaluation.

The sucroglycerides Independent

Safety Determination was affirmed by

an expert panel in 1991 which

examined only sucroglycerides

manufactured from palm oil. The same

expert panel re-convened in 1994 to

evaluate sucroglycerides manufactured

from edible fats and oils. This

addendum to the Independent Safety

Determination differed only in that the

starting materials could be any edible fat

or oil as opposed to palm oil only as

originally evaluated in 1991. The panel

concluded that sucroglycerides are

GRAS for use in the food applications

considered when used in accordance

with good manufacturing practices.

The intended food applications

evaluated as part of the Independent

Safety Determination included use as a

texturizer in biscuit mixes, and as an

emulsifier in baked goods and baking

mixes, dairy product analogs, frozen

dairy desserts and mixes, and whipped

milk products. The maximum estimated

content of sucroglycerides in these

anticipated food uses is 1.5%. Under 21

CFR 172.859, a related mixture, sucrose

fatty acid esters, can be used as direct

food additives as emulsifiers in various

baked goods and baking mixes, dairy

and dairy analog products, chewing

gum, confections and frostings, and

coffee and tea beverages with added

dairy or dairy analog products, as

texturizers in chewing gum, confections

and frostings, and surimi-based

fabricated seafood products, and as

components of protective coatings

applied to fresh fruit to retard ripening

and spoiling. Under 21 CFR 184.1505,

mono- and di-glycerides prepared from

fats or oils are GRAS.

V. 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

sucroglycerides are discussed in this

unit.

The submission to the Agency

consisted of two studies (subchronic

and chronic toxicity/carcinogenicity)

that contained individual animal data.

These two studies were reviewed as

guideline studies, that is, studies that

meet the Agency’s criteria for a wellconducted study that supplies the

necessary information. The other

submissions consisted of toxicology

study summaries. The summaries varied

in the amount of information presented.

Some were literature reports and partial

translations of studies conducted in

France. Thus, these summaries provided

useful information to the Agency which

was used during the weight-of-theevidence evaluation.

1. Acute. The summary reported an

acute toxicity study in which no adverse

effects were reported. The LD50 was

estimated to be greater than 30 gram/

kilogram body weight (g/kg bwt).

2. Subchronic toxicity. In a 13-week

dog feeding study sucroglycerides were

administered to 5 pure bred Beagle

dogs/sex/dose in the diet at dose levels

of 0, 5, 10, or 20% (control, 1.19, 2.59,

or 5.61 gram/kilogram/day (g/kg/day)

for males and control, 1.31, 2.57, or 4.7

g/kg/day for females). Three animals/

sex/dose were sacrificed after 13 weeks,

and the remaining two animals/sex/dose

continued on for an additional 8 weeks

of observation on control diets, and

were then sacrificed.

No animals died on study and there

was no overt toxicity. The decreased

cholesterol levels, increased SGPT

(serum glutamic pyruvic transaminase)

values, ad hepatic pathology are effects

that are comparable to those seen as a

result of a high fat dietary intake. The

grossly high doses of this fatty

compound were over the limit dose and

effects seen cannot readily be

distinguished from those observed with

a high fat diet. The NOAEL (no observed

adverse effect level) was at the 10%

level (2.6 g/kg/day for males and

females). The LOAEL (lowest-observed

adverse effect level) was determined to

be at the 20% level (5.6 g/kg/day for

males and 4.7 g/kg/day for females).

This study is classified as acceptable

and satisfies the guideline requirement

for a subchronic oral study in dogs.

In a different study, the summary

reported that administration of

sucroglycerides to rats for 100 days at

concentrations up to 10% in the diet

resulted in increased body weight gain

and increased hepatic, total lipids and

22130 Federal Register / Vol. 66, No. 86 / Thursday, May 3, 2001 / Rules and Regulations

lipid fractions with normal plasma lipid

levels.

3. Combined chronic toxicity/

carcinogenicity 2-year rat study. In this

study sucroglycerides were

administered via the diet to 50 rats/sex/

group at dose levels of 0, 5, 10, or 20%

(control, 1.59, 3.37, or 7.70 g/kg/day in

males and control, 1.86, 4.01, or 9.25 g/

kg/day in females for up to 108 weeks).

No adverse effects were observed in

mortality, hematology, blood chemistry,

ophthalmoscopy, organ weights, or

gross pathology parameters for either

sex at any treatment level. The NOAEL

for this combined chronic/

carcinogenicity rat feeding study is 5%

(3.37 g/kg/day for males and 4.01 g/kg/

day for females). The LOAEL is 10%

(7.70 g/kg/day for males and 9.25 g/kg/

day for females) based on decreased

food efficiency in males.

Under the conditions of this study,

dosing is considered adequate to assess

the carcinogenic potential of

sucroglycerides based on the fact that

the compound was administered at

doses above the limit dose, food

efficiency was reduced at 10% in males,

and body weight and body weight gain,

along with food efficiency was

increased at 20% in both sexes. The

administration of sucroglycerides to rats

up to 20% in the diet did not result in

an overall treatment-related increase in

incidence of tumor formation. This

study is classified as acceptable and

satisfies the guideline requirement for a

chronic toxicity/carcinogenicity oral

study in rats.

In a different study, the summary

reported that in a 25 to 28–month rat

study, food efficiency was decreased at

10% lard sucroglyceride in the diet. No

other effects were noted.

Summaries of another two long-term

rat studies with 5 g/kg bwt

sucroglycerides in the diet were

submitted. These also demonstrated no

adverse effects and no evidence of

carcinogenicity.

4. Mutagenicity. No mutagenicity

studies were submitted to the Agency.

However, none of the components of

sucroglycerides are known mutagens.

Given this information and since the

combined chronic toxicity/

carcinogenicity study did not result in

an overall treatment-related increase in

incidence of tumor formation,

mutagenicity studies will not be

required.

5. Developmental/reproductive

toxicity. No developmental or

reproductive toxicity guideline studies

were submitted to the Agency, although

summaries of two chronic toxicity/2-

generation reproductive studies were

submitted. Both summaries were partial

translations of French studies. Both

summaries reported no adverse effects.

In a 1987 article in open literature

describing a 2-generation reproductive

and developmental toxicity study of a

related compound, sucrose polyester (a

mixture of hexa-, hepta-, and octa-esters

of edible grade fatty acids with sucrose),

was fed to rats at up to 10% of the diet.

There were no adverse effects on

reproductive function, on the

development of the fetus, or on the

viability or growth of the offspring into

adult life.

Given the observed lack of

developmental and reproductive effects,

and the fact the mono- and di-glycerides

are not know developmental toxicants,

guideline developmental and

reproductive studies will not be

required.

6. Dermal toxicity. No dermal studies

were submitted to the Agency. Sucrose

esters of fatty acids and mono-and diglycerides are unlikely to be absorbed

through the skin in sufficient amounts

to cause toxicity.

7. Neurotoxicity. No neurotoxicity

studies were submitted to the Agency.

However, no neurotoxicity was

observed in the oral guideline studies.

The submitted toxicity studies

demonstrate the low toxicity of

sucroglycerides. For sucroglycerides, in

several studies minimal effects occurred

at doses that were expressed as grams of

sucroglycerides per kilogram of animal

body weight per day. For many

chemicals, the Agency has reviewed

data that demonstrate significant effects

at doses that are expressed in milligrams

per kilogram of animal body weight per

day. Thus, the minimal toxicity that

occurred with consumption of

sucroglycerides, occurred at higher dose

levels than normally used in testing.

VI. 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 it can be clearly

demonstrated that 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

sucroglycerides could be present in all

raw and processed agricultural

commodities and drinking water, and

that non-occupational non-dietary

exposure was possible.

1. Food. As previously stated,

sucroglycerides have self-affirmed

GRAS status. EPA will regulate only the

use of sucroglycerides as an inert

ingredient in pesticide formulations.

Thus, the amount of sucroglycerides

that can be applied to food as a result

of their use in a pesticide product as an

inert ingredient would not significantly

increase the amount of sucroglycerides

in the food supply above those amounts

permitted by FDA.

2. Drinking water exposure. The

solubility of sucroglycerides in water is

very low, less than 1 part per billion.

Given this low solubility in water and

the low toxicity, both of which were

demonstrated in testing, the Agency has

determined that exposure for all human

population groups through drinking

water would be extremely low.

B. Other Non-Occupational Exposure

Currently, there are no residential

uses of sucroglycerides. Given that

sucroglycerides are unlikely to be

absorbed through the skin in sufficient

amounts to cause toxicity, even if

residential uses of sucroglycerides were

to occur, toxicity would not occur.

VII. 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.’’

Sucroglycerides have a demonstrated

lack of toxicity, and thus are unlikely to

share a common mechanism of toxicity

with any other substances.

Federal Register / Vol. 66, No. 86 / Thursday, May 3, 2001 / Rules and Regulations 22131

VIII. Determination of Safety for U.S.

Population

Given the available toxicity

information indicating minimal effects,

there should be no concerns for human

health, whether the exposure is acute,

subchronic, or chronic. Thus, based on

the low toxicity of sucroglycerides and

the low potential for exposure from the

EPA regulated uses of sucroglycerides,

the Agency has determined that there is

a reasonable certainty of no harm to the

U.S. population from aggregate exposure

to residues of sucroglycerides and that

a tolerance is not necessary.

IX. 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

safety will be safe for infants and

children. Due to the expected low

toxicity of sucroglycerides, 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 sucroglycerides and that a

tolerance is not necessary.

X. Other Considerations

A. Endocrine Disruptors

There is no available evidence that

sucroglycerides are an endocrine

disruptor.

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

sucroglycerides.

D. International Tolerances

The Agency is not aware of any

country requiring a tolerance for

sucroglycerides nor have any CODEX

Maximum Residue Levels (MRLs) been

established for any food crops at this

time.

XI. 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

sucroglycerides. Accordingly, EPA finds

that exempting sucroglycerides from the

requirement of a tolerance will be safe.

XII. 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–301119 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 July 2, 2001.

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–301119, 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

22132 Federal Register / Vol. 66, No. 86 / Thursday, May 3, 2001 / Rules and Regulations

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).

XIII. Regulatory Assessment

Requirements

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).

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

responsibilities between the Federal

government and Indian tribes, as

specified in Executive Order 13175.

Thus, Executive Order 13175 does not

apply to this rule.

XIV. 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: April 13, 2001.

James Jones,

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) * * *

Federal Register / Vol. 66, No. 86 / Thursday, May 3, 2001 / Rules and Regulations 22133

Inert ingredients Limits Uses

*******

Glycerides, edible fats and oils derived from plants and animals, reaction products with sucrose (CAS Reg. Nos.

100403–38–1, 100403–41–6, 100403–39–2, 100403–40–

5)

emulsifier, dispersing agent.

*******

[FR Doc. 01–11093 Filed 5–2–01; 8:45 am]

BILLING CODE 6560–50–S

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 54

[CC Docket No. 96–45; FCC 01–120]

Federal-State Joint Board on Universal

Service: Children’s Internet Protection

Act

AGENCY: Federal Communications

Commission.

ACTION: Final rule, correction.

SUMMARY: This document corrects errors

in the final rule portion regarding

implementation of the Children’s

Internet Protection Act (CIPA)

published in the Federal Register on

April 16, 2001.

DATES: Effective May 3, 2001.

FOR FURTHER INFORMATION CONTACT:

Jonathan Secrest or Narda Jones,

Attorney, Common Carrier Bureau,

Accounting Policy Division, (202) 418–

7400.

SUPPLEMENTARY INFORMATION: This

summary contains corrections to the

rule portion of the Commission’s Report

and Order, CC Docket No. 96–45; FCC

01–120, 66 FR 19394 (April 16, 2001).

The full text of the Commission’s Report

and Order 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.

Correction

1. On page 19396, in the third

column, ‘‘Subpart H—Administration’’

is corrected to read ‘‘Subpart F—

Universal Service Support for Schools

and Libraries’’.

2. On page 19396, in the third

column, in paragraph 2, ‘‘subpart H’’ is

corrected to read ‘‘subpart F’’.

3. In § 54.20, on page 19397, in the

third column, in paragraphs

(c)(2)(iii)(A), (c)(2)(iii)(B), and

(c)(2)(iii)(C), the phrase ‘‘for which you

have requested or received Funding

Commitments’’ is corrected to read ‘‘on

this Form 486.’’

4. In § 54.520, on page 19397, in the

third column, paragraph (c)(3)(i) is

corrected by inserting after the phrase

‘‘paragraph (a)(3) of this section,’’ the

following phrase ‘‘other than one

requesting only discounts on

telecommunications services for

consortium members.’’

5. In § 54.520, on page 19398, in the

first column, in paragraph (c)(3)(ii) the

phrase ‘‘duly completed and signed

certifications’’ is corrected to read ‘‘duly

completed and signed Forms 479,’’ and

the phrase ‘‘received under the

universal service support mechanism

by’’ is corrected to read ‘‘that I have

been approved for discounts under the

universal service support mechanism on

behalf of,’’ and by inserting opening

quotation marks after the phrase ‘‘or I

certify’’.

6. In § 54.520, on page 19398, in the

third column, in paragraph (f),

‘‘December 21, 2000’’ is corrected to

read ‘‘April 20, 2001’’ and by inserting

the phrase ‘‘or library’’ after the phrase

‘‘in which the school’’.

Federal Communications Commission.

Magalie Roman Salas,

Secretary.

[FR Doc. 01–11063 Filed 5–2–01; 8:45 am]

BILLING CODE 6712–01–U

DEPARTMENT OF COMMERCE

National Oceanic and Atmospheric

Administration

50 CFR Part 216

Regulations Governing the Taking and

Importing of Marine Mammals

CFR Correction

In Title 50 of the Code of Federal

Regulations, parts 200 to 599, revised as

of October 1, 2000, Part 216 is corrected

by removing Subpart N (§ § 216.151

through 216.157).

[FR Doc. 01–55515 Filed 5–2–01; 8:45 am]

BILLING CODE 1505–01–D