75174 Federal Register / Vol. 65, No. 232 / Friday, December 1, 2000 / Rules and Regulations

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301071; FRL–6748–5]

RIN 2070–AB78

Hydrogen Peroxide; 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 Hydrogen

Peroxide, in or on all raw and processed

food commodities when used in

sanitizing solutions containing a diluted

end-use concentration of hydrogen

peroxide up to 1,100 ppm, and applied

to tableware, utensils, dishes, pipelines,

tanks, vats, fillers, evaporators,

pasteurizers, aseptic equipment, milking

equipment, and other food processing

equipment in food handling

establishments including, but not

limited to dairies, dairy barns,

restaurants, food service operations,

breweries, wineries, and beverage and

food processing plants. Ecolab,

Incorporated submitted a petition to

EPA under the Federal Food, Drug, and

Cosmetic Act, (FFDCA) as amended by

the Food Quality Protection Act (FQPA)

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 hydrogen peroxide. This

final rule reinserts, and amends the

hydrogen peroxide exemption that was

deleted from the July 1, 1998 edition of

40 CFR; incorporates the currently

published hydrogen peroxide

exemption, unchanged and adds the

subject hydrogen peroxide exemption.

This final rule is being published with

a companion final rule titled

‘‘Peroxyacetic Acid; Exemption from the

Requirement of a Tolerance.’’

DATES: This regulation is effective

December 1, 2000. Objections and

requests for hearings, identified by

docket control number OPP–301071,

must be received by EPA on or before

January 30, 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–301071 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Marshall Swindell, Product

Manager 33, Antimicrobial Division

(7510C), Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: 703–308–

6341; and e-mail address:

swindell.marshall@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

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–301071. 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 February 3,

1999 (64 FR 22) (FRL–5273–7), EPA

issued a notice pursuant to section 408

of the FFDCA, 21 U.S.C. 346a, as

amended by the FQPA (Public Law 104–

170) announcing the filing of a pesticide

tolerance petition by Ecolab, Inc. This

notice included a summary of the

petition prepared by the petitioner

Ecolab, Inc. There were no comments

received in response to the notice of

filing.

The petition requested that 40 CFR

180.1197 be amended by establishing an

exemption from the requirement of a

tolerance for residues of hydrogen

peroxide.

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....’’

Federal Register / Vol. 65, No. 232 / Friday, December 1, 2000 / Rules and Regulations 75175

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

hydrogen peroxide are discussed in this

unit.

Ecolab, Inc., has requested a waiver of

all toxicology testing requirements for

hydrogen peroxide. This includes

waivers for all acute, 90–day

subchronic, chronic, oncogenicity,

developmental, reproductive,

mutagenicity, neurotoxicity and

metabolism requirements for hydrogen

peroxide. The Agency has reviewed the

data waivers requested and concurs that

no additional generic toxicology testing

will be needed for hydrogen peroxide

for the following reasons:

1. Hydrogen peroxide is highly

reactive and short lived because of the

inherent instability of the peroxide bond

(ie., the O-O bond). Agitation or contact

with rough surfaces, sunlight, organics

and metals accelerates decomposition.

The instability of hydrogen peroxide to

exist as itself, along with detoxifying

enzymes found in cells (eg., catalase,

glutathione peroxidase), makes it very

difficult to find any residues of

hydrogen peroxide in or on foods (at

proposed use levels), by conventional

analytical methods.

The proposed food contact

applications also utilize very low

concentrations of hydrogen peroxide.

Therefore, food residues are expected to

be short-lived, based on half-lives for

hydrogen peroxide as short as a few

minutes under certain conditions.

Residues are not of toxicological

concern because hydrogen peroxide

decomposes rapidly into oxygen and

water. The Agency has no toxicological

concern with oxygen and water.

2. There are acceptable acute generic

data referenced in the Reregistration

Eligibility Document for Peroxy

Compounds (December 1993, Case

4072). Hydrogen peroxide was found to

be corrosive and severely irritating to

the eyes, skin, and mucous membranes

but only when high concentrations were

used. The proposed use patterns are

expected to result in a lack of any

residues of toxicological concern.

3. A waiver was granted for all the

remaining toxicology testing

requirements because of the reasons

given above, and because there is an

extensive data base assembled by the

Agency’s Office of Water. Although the

Office of Water’s data does show

toxicological effects in experimental

animals, these effects occur only at high

doses that are not expected from the

proposed uses of hydrogen peroxide. In

addition, the rapid decomposition of

hydrogen peroxide into oxygen and

water, which are not of toxicological

concern, mitigates any concern for

residues.

Therefore, the lack of any residues of

toxicological concern and the existence

of toxicological effects only at high dose

levels in experimental animals

minimizes any concern for exposure to

the very low doses that may be present

as a result of the proposed uses.

The Agency also recognizes that

commercially available 3% hydrogen

peroxide solutions have been used for

many years for personal and medical

uses. The use directions for some of

these products state that these 3%

solutions can be used as a sanitizing

mouthwash. Other food contact and

medicinal uses for hydrogen peroxide

include applications for wines and

liquors (artificial aging), dentifrices,

sanitary lotions, and pharmaceutical

preparations.

The long use history of hydrogen

peroxide and weight of empirical

evidence and experimental data has led

the Food and Drug Administration

(FDA) to put hydrogen peroxide on the

Generally Recognized As Safe (GRAS)

list when used on food processing

equipment, utensils, and food contact

articles (21 CFR part 178). Potential

symptoms of acute over exposure to

medium or high concentrations of

hydrogen peroxide include irritation of

eyes, nose and throat, corneal

ulceration, erythema, vesicles on skin,

and bleaching of hair.

IV. Aggregate Exposures

A. Dietary Exposure

1. Food. For the proposed sanitizer

uses, the 11.2% (by weight) concentrate

of hydrogen peroxide will be diluted

with potable water at the rate of 1 to 1.8

ounces of concentrated product per

1,024 ounces (8 gallons) of dilution

water for food contact surfaces (eg., food

packaging equipment), and for eating,

drinking, and food preparation utensils.

For low temperature (120 degrees F)

tableware sanitization in warewashing

machines, the dilution rate is 1 ounce of

concentrated product per 3,840 ounces

(30 gallons) of dilution water.

These dilution rates correspond to a

concentration range of hydrogen

peroxide in the sanitizer product at the

time of application of 29 to 202 parts

per million (ppm). The sanitizer

solution, having a low concentration of

hydrogen peroxide, reacts on contact

with the surface on which it is applied

and degrades rapidly into oxygen and

water which pose no toxicological

concern. Therefore, residues of

hydrogen peroxide resulting from its use

in sanitizer solutions even up to 1,100

ppm are expected to be negligible on all

raw and processed food commodities.

The difference between the 202 ppm

maximum end use concentration, and

the 1,100 ppm exemption concentration

requested by Ecolab, is warranted to

overcome any degradation of hydrogen

peroxide during transport and non-use

periods, and to provide flexibility for

changes in formulation.

Additional dietary sources of the

GRAS substance hydrogen peroxide are

not expected to be significant and range

in concentration from 0.04 to 1.25% in

the FDA food contact approvals cited

below:

Under 21 CFR 184.1366, hydrogen

peroxide is GRAS when used on milk

intended for use in cheese making

(maximum treatment level of 0.05%),

whey, during preparation of modified

whey by electrodialysis methods

(maximum treatment level of 0.04%),

dried eggs, dried egg whites, and dried

egg yolks, tripe, beef feet, herring, wine,

starch (maximum treatment level of

0.15%), instant tea, corn syrup

(maximum treatment level of 0.15%),

colored cheese whey (maximum

treatment level of 0.05%), wine vinegar,

and emulsifiers containing fatty acid

esters (maximum treatment level of

1.25%).

Hydrogen peroxide presently has the

following additional EPA and FDA

clearances:

Under 40 CFR 180.1197 as a direct

application at 120 ppm to fruits,

vegetables, tree nuts, cereal grains, herbs

and spices.

Under 21 CFR 172.892 for

modification of food starch to be added

to human food items.

Under 21 CFR 178.1005 for

sterilization of polymeric food surfaces.

Sanitizing solution is not to contain

more than 35% hydrogen peroxide.

Under 21 CFR 178.1010(b)(30) for

sanitizing solutions used on foodVerDate 11<MAY>2000 09:16 Nov 30, 2000 Jkt 194001 PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 E:\FR\FM\01DER1.SGM pfrm04 PsN: 01DER1
75176 Federal Register / Vol. 65, No. 232 / Friday, December 1, 2000 / Rules and Regulations

processing equipment and utensils and

on other food contact articles. Sanitizing

solutions may contain not less than 550

ppm nor more than 1,100 ppm hydrogen

peroxide (21 CFR 178.1010(c)(25)).

Under 21 CFR 184.136 as GRAS when

hydrogen peroxide meets Food

Chemical Codex specifications, to treat

certain foods as a antimicrobial,

bleaching agent, oxidizing and reducing

agent. Residual hydrogen peroxide must

be removed during processing of food.

Under 21 CFR 173.315(a)(2) for use in

washing or to assist in the lye peeling

of fruits and vegetables that are not raw

agricultural commodities. Used in

combination with acetic acid. Not to

exceed 59 ppm in wash water.

Under 21 CFR 178.1010(c)(33) for

sanitizing solutions used on food

processing equipment and dairy

processing equipment. Sanitizing

solutions may contain not less than 300

ppm nor more than 465 ppm of

hydrogen peroxide.

2. Drinking water exposure. Use of

hydrogen peroxide for indoor food

equipment sanitization uses is not

expected to result in the transfer of any

residues to potential drinking water

sources. Therefore, no risk assessment is

warranted.

B. Other Non-Occupational Exposure

Hydrogen peroxide is currently

registered by EPA for a wide variety of

uses. These includes use as a water

additive for control of spoilage

microorganisms on raw and processed

food commodities; use as an algaecide,

fungicide and bactericide on growing

crops and post harvest potatoes; use on

agricultural premises and equipment,

food handling/storage establishments

premises and equipment; use on

commercial, institutional and industrial

premises and equipment; use on

residential, public access premises,

medical premises and equipment; use

for materials preservation; and for

industrial processes and water systems.

Hydrogen peroxide is also approved

for a variety of medicinal uses including

sanitization of scrapes, cuts, and burns

to human and animal skin, and as a

human oral sanitizing mouthwash. It is

also used by medical doctors for general

cleansing and sanitization of surgical

areas of the body after operations.

Hydrogen peroxide use in homes is

medicinal and exposures are expected

to be infrequent and at extremely short

topical duration.

The Agency does not know of all

approved or actual uses for hydrogen

peroxide. However, non-dietary

exposures are not expected to pose any

quantifiable added risk because of a lack

of any significant residues of

toxicological concern.

V. Cumulative Effects

The FQPA (1996) stipulates that when

determining the safety of a pesticide

chemical, EPA shall consider, among

other things, available information

concerning the cumulative effects to

human health that may result from

dietary, residential, or other nonoccupational exposure to other

substances that have a common

mechanism of toxicity. The reason for

consideration of other substances is due

to the possibility that low-level

exposures to multiple chemical

substances that cause a common toxic

effect by a common mechanism could

lead to the same adverse health effect as

would a higher level of exposure to any

of the other substances individually. A

person exposed to a pesticide at a level

that is considered safe may in fact

experience harm if that person is also

exposed to other substances that cause

a common toxic effect by a mechanism

common with that of the subject

pesticide, even if the individual

exposure levels to the other substances

are also considered safe.

Because of the low use rates of

hydrogen peroxide, its low toxicity, and

rapid degradation, EPA does not believe

that there are any concerns regarding

the potential for cumulative effects of

hydrogen peroxide with other

substances due to a common

mechanism of action.

VI. Determination of Safety for U.S.

Population, Infants and Children

Because hydrogen peroxide is of low

toxicity, and the proposed uses employ

low concentrations of hydrogen

peroxide, and hydrogen peroxide

degrades rapidly following application,

EPA concludes that this exemption from

the requirement of a tolerance in or on

all raw and processed food

commodities, when hydrogen peroxide

is used in diluted sanitizing solutions

up to 1,100 ppm, poses no dietary risk

to the U.S. population including infants

and children, under reasonably

forseeable circumstances. Further, EPA

finds that there is a reasonable certainty

of no harm from aggregate exposure to

hydrogen peroxide and thus that the

exemption for hydrogen peroxide is

safe. The Agency’s human risk

assessment findings are summarized

below.

1. Acute dietary risk assessment.

Acute dietary risk assessments are

performed for a food-use pesticide if a

toxicological study has indicated the

possibility of an effect of concern

occurring as a result of a one day or

single exposure. No acute exposure and

risk assessment is applicable because no

acute toxicological effects of concern or

exposure are anticipated with the

proposed food contact uses for hydrogen

peroxide. This is due to the lack of any

residues of toxicological concern as a

result of the automatic and rapid

decomposition of hydrogen peroxide

into oxygen and water. Use of hydrogen

peroxide for indoor food equipment

sanitization uses is not expected to

result in the transfer of any residues to

potential drinking water sources.

2. Chronic dietary risk assessment.

Residues of hydrogen peroxide are not

expected to remain on the surface of

materials which it contacts. Therefore,

the risk from dietary exposure is

expected to be negligible. No chronic

exposure and risk assessment is

applicable because no chronic

toxicological effects are anticipated with

the proposed food contact uses for

hydrogen peroxide. This is due to the

lack of any residues of toxicological

concern as a result of the automatic and

rapid decomposition of hydrogen

peroxide into oxygen and water. Use of

hydrogen peroxide for indoor food

equipment sanitization uses is not

expected to result in the transfer of any

residues to potential drinking water

sources.

3. Aggregate cancer risk for U.S.

population. Available data suggest that

hydrogen peroxide can act as a promoter

of carcinogenisis at relatively high doses

(in excess of 600 milligrams/kilograms

(mg/kg)) after chronic administration in

drinking water to experimental animals.

Epidemiological reports indicate that

the major effect from accidental

ingestion of high doses of hydrogen

peroxide in humans (ie., 1,000 mg/kg) is

acute and severe clinical toxicity, which

in a few cases resulted in death.

Based on the proposed use

concentrations for hydrogen peroxide,

and data indicating negligible residues

on food, exposure to hydrogen peroxide

under the proposed food contact use

concentrations is not likely to result in

any adverse clinical effects, including

promotion of carcinogenisis. This

conclusion is supported further by the

rapid decomposition of hydrogen

peroxide into oxygen and water, which

are not of toxicological concern, and the

existence of specific enzymes (ie.,

catalase and glutathione peroxidases)

for breakdown of hydrogen peroxide.

Therefore, the Agency concludes that

the cancer risk for the U.S. population

from aggregate exposure to hydrogen

peroxide is negligible under the

proposed food contact use

concentrations.

Federal Register / Vol. 65, No. 232 / Friday, December 1, 2000 / Rules and Regulations 75177

4. Aggregate risks and determination

of safety for infants and children. In

assessing the potential for additional

sensitivity of infants and children to

residues of hydrogen peroxide, EPA

considered data from developmental

and reproductive toxicity studies

available from the scientific literature

and summarized by the Office of Water.

The developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

maternal pesticide exposure during

gestation. Reproduction studies provide

information relating to effects from

exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

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 determines that a different margin

of safety will be safe for infants and

children.

Margins of safety are incorporated

into EPA risk assessments either

directly through use of a margin of

exposure (MOE) analysis or through

using uncertainty (safety) factors (UF) in

calculating a dose level that poses no

appreciable risk to humans. In either

case, EPA generally defines the level of

appreciable risk as exposure that is

greater than 1/100 of the no observed

adverse effect level (NOAEL) in the

animal study appropriate to the

particular risk assessment. This 100-fold

UF/MOE is designed to account for

interspecies extrapolation and

intraspecies variability.

In the case of the proposed food

contact uses for hydrogen peroxide,

because of the lack of any residues of

toxicological concern, a NOAEL was not

identified for risk assessment purposes,

and the uncertainty (safety) factor

approach was not used for assessing any

risk level by hydrogen peroxide. For the

same reason, an additional safety factor

to protect infants and children is

unnecessary. Additionally, based on the

following, no increased susceptibility to

infants or children is expected to occur.

i. Three older studies on the

developmental and reproductive effects

of hydrogen peroxide are available. The

data from these studies indicates that no

apparent developmental or reproductive

effects were observed from

administration of hydrogen peroxide at

concentrations up to 1% (1,000 mg/kg).

ii. Hydrogen peroxide is highly

reactive and short lived because of the

inherent instability of the peroxide bond

(ie., the O-O bond). Agitation or contact

with rough surfaces and metals

accelerates dissociation. The proposed

food contact applications utilize very

low concentrations of hydrogen

peroxide (i.e ppm). Food residues are

expected to be short-lived and are not

expected to accumulate. This is because

hydrogen peroxide dissociates rapidly

in air into oxygen and water. The

Agency has no toxicological concern

with oxygen and water.

iii. A waiver was granted for all the

remaining toxicology testing

requirements because of the reasons

given in items a and b above, and

because there is an extensive data base

assembled by the Agency’s Office of

Water showing toxicological effects in

experimental animals only at high

concentrations, which are not expected

with the proposed use patterns.

iv. The Agency also recognizes that

commercially available 3% hydrogen

peroxide solutions have been used for

many years for personal and medical

uses. The use directions for some of

these products state that these solutions

can be used as a sanitizing mouthwash.

The long use history of hydrogen

peroxide and weight of empirical and

experimental data has led the FDA to

put it on the GRAS list when used on

food processing equipment, utensils,

and food contact articles (21 CFR part

178).

Therefore, because of the rapid

decomposition of hydrogen peroxide

residues into degradates that are of no

toxicological concern (ie., oxygen,

water), the Agency concludes that there

is a reasonable certainty of no harm for

infants and children from exposure to

hydrogen peroxide under the proposed

food contact use concentrations.

VII. Other Considerations

A. Endocrine Disruptors

The FQPA (1996) requires that EPA

develop a screening program to

determine whether certain substances

(including all pesticides and inerts)

‘‘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,

including other government agencies,

public interest groups, and industry and

research scientists to develop a

screening and testing program as well as

a priority setting scheme to implement

this program. The Agency’s proposed

Endocrine Disrupter Screening Program

was published in the Federal Register

on December 28, 1998 (63 FR 71541). As

the Agency proceeds with

implementation of this program, further

testing of hydrogen peroxide for

endocrine effects may be required. The

currently available animal data suggest

no significant endocrine effects from

exposure to hydrogen peroxide.

B. Analytical Method(s)

Because an exemption from the

requirement of a tolerance without

numerical limitation for residues in

food is being granted for hydrogen

peroxide, an enforcement analytical

method is not needed. However, an

analytical method (designated QATM

202 by Ecolab, Inc., a redoxtitration

procedure) is available in cases of gross

misuse. The analytical method is being

made available to anyone interested in

pesticide enforcement when requested,

from Norm Cook, Antimicrobials

Division (7510C), Office of Pesticide

Programs, U.S. Environmental

Protection Agency, 1200 Pennsylvania

Avenue, NW., Washington, DC 20460.

Office location and telephone number:

1921 Jefferson Davis Highway, 3rd

Floor, Arlington, VA 22202, 703–308–

8253.

C. Existing Tolerances

In 40 CFR 180.1197, an exemption

from the requirement of a tolerance is

established for residues of hydrogen

peroxide in or on all food commodities

at the rate of less than or equal to 1%

hydrogen peroxide per application on

growing crops and post harvest

potatoes, when applied as an algaecide,

fungicide, and bactericide.

D. International Tolerances

There are no Codex Alimentarius

(Codex) Commission Maximum Residue

Levels for Hydrogen Peroxide.

VIII. 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.

75178 Federal Register / Vol. 65, No. 232 / Friday, December 1, 2000 / Rules and Regulations

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–301071 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 January 30, 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–301071, 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 file

format 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).

IX. 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 prior consultation as specified by

Executive Order 13084, entitled

Consultation and Coordination with

Indian Tribal Governments (63 FR

27655, May 19, 1998); special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994); or require 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

Federal Register / Vol. 65, No. 232 / Friday, December 1, 2000 / Rules and Regulations 75179

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).

X. 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: November 9, 2000.

Frank Sanders,

Director, Antimicrobial 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 180.1197, is revised to read

as follows:

§ 180.1197 Hydrogen Peroxide; exemption

from the requirement of a tolerance.

(a) An exemption from the

requirement of a tolerance is established

for residues of hydrogen peroxide in or

on raw agricultural commodities, in

processed commodities, when such

residues result from the use of hydrogen

peroxide as an antimicrobial treatment

in solutions containing a diluted enduse concentration of hydrogen peroxide

up to 120 ppm per application on fruits,

vegetables, tree nuts, cereal grains,

herbs, and spices.

(b) An exemption from the

requirement of a tolerance is established

for residues of hydrogen peroxide in or

on all food commodities at the rate of

less than or equal to 1% hydrogen

peroxide per application on growing

crops and post harvest potatoes when

applied as an algaecide, fungicide and

bactericide.

(c) An exemption from the

requirement of a tolerance is established

for residues of hydrogen peroxide, in or

on all raw and processed food

commodities when used in sanitizing

solutions containing a diluted end-use

concentration of hydrogen peroxide up

to 1,100 ppm, and applied to tableware,

utensils, dishes, pipelines, tanks, vats,

fillers, evaporators, pasteurizers, aseptic

equipment, milking equipment, and

other food processing equipment in food

handling establishments including, but

not limited to dairies, dairy barns,

restaurants, food service operations,

breweries, wineries, and beverage and

food processing plants.

[FR Doc. 00–30680 Filed 11–30–00; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 300

[FRL–6910–4]

National Priorities List for Uncontrolled

Hazardous Waste Sites

AGENCY: Environmental Protection

Agency.

ACTION: Final rule.

SUMMARY: The Comprehensive

Environmental Response,

Compensation, and Liability Act of 1980

(‘‘CERCLA’’ or ‘‘the Act’’), as amended,

requires that the National Oil and

Hazardous Substances Pollution

Contingency Plan (‘‘NCP’’) include a list

of national priorities among the known

releases or threatened releases of

hazardous substances, pollutants, or

contaminants throughout the United

States. The National Priorities List

(‘‘NPL’’) constitutes this list. The NPL is

intended primarily to guide the

Environmental Protection Agency

(‘‘EPA’’ or ‘‘the Agency’’) in determining

which sites warrant further

investigation to assess the nature and

extent of public health and

environmental risks associated with the

site and to determine what CERCLAfinanced remedial action(s), if any, may

be appropriate. This rule adds 8 new

sites to the NPL; 7 sites to the General

Superfund Section of the NPL and one

site to the Federal Facilities Section.

EFFECTIVE DATE: The effective date for

this amendment to the NCP shall be

January 2, 2001.

ADDRESSES: For addresses for the

Headquarters and Regional dockets, as

well as further details on what these

dockets contain, see Section II,

‘‘Availability of Information to the

Public’’ in the ‘‘Supplementary

Information’’ portion of this preamble.

FOR FURTHER INFORMATION CONTACT:

Yolanda Singer, phone (703) 603–8835,

State, Tribal and Site Identification

Center; Office of Emergency and

Remedial Response (mail code 5204G);

U.S. Environmental Protection Agency;

1200 Pennsylvania Avenue NW.,

Washington, DC 20460; or the

Superfund Hotline, phone (800) 424–

9346 or (703) 412–9810 in the

Washington, DC, metropolitan area.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background

A. What are CERCLA and SARA?

B. What is the NCP?

C. What is the National Priorities List

(NPL)?

D. How are Sites Listed on the NPL?

E. What Happens to Sites on the NPL?

F. How are Site Boundaries Defined?

G. How are Sites Removed from the NPL?

H. Can Portions of Sites be Deleted from

the NPL as They Are Cleaned Up?

I. What is the Construction Completion List

(CCL)?

II. Availability of Information to the Public

A. Can I Review the Documents Relevant

to this Final Rule?

B. What Documents are Available for

Review at the Headquarters Docket?

C. What Documents are Available for

Review at the Regional Docket?

D. How Do I Access the Documents?

E. How Can I Obtain a Current List of NPL

Sites?

III. Contents of This Final Rule

A. Additions to the NPL

B. Status of NPL

C. What did EPA Do with the Public

Comments It Received?

IV. Executive Order 12866

A. What is Executive Order 12866?

B. Is this Final Rule Subject to Executive

Order 12866 Review?

V. Unfunded Mandates

A. What is the Unfunded Mandates Reform

Act (UMRA)?

B. Does UMRA Apply to This Final Rule?

VI. Effects on Small Businesses

A. What is the Regulatory Flexibility Act?

B. Does the Regulatory Flexibility Act

Apply to this Final Rule?

VII. Possible Changes to the Effective Date of

the Rule

A. Has This Rule Been Submitted to

Congress and the General Accounting

Office?

B. Could the Effective Date of This Final

Rule Change?