Federal Register / Vol. 63, No. 87 /Wednesday, May 6, 1998 /Rules and Regulations 24955

the factual issues on which a hearing is

requested, the requestor’s contentions

on such issues, and a summary of any

evidence relied upon by the requestor

(40 CFR 178.27).

A request for a hearing will be granted

if the Administrator determines that the

material submitted shows the following:

There is 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 in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

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.

VI. Public Docket

EPA has established a record for this

rulemaking under docket control

number [OPP–300654] (including any

comments and data submitted

electronically). A public version of this

record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as CBI, is available for

inspection from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays.

The public record is located in Room

119 of the Public Information and

Records Integrity Branch, Information

Resources and Services Division

(7502C), Office of Pesticide Programs,

Environmental Protection Agency,

Crystal Mall #2, 1921 Jefferson Davis

Hwy., Arlington, VA.

Electronic comment may be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

VII. 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)

(Pub. L. 104-4). Nor does it require any

prior consultation as specified by

Executive Order 12875, entitled

Enhancing the Intergovernmental

Partnership (58 FR 58093, October 28,

1993), or 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 in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

Risks (62 FR 19885, April 23, 1997).

In addition, since these 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.

Nevertheless, the Agency has previously

assessed whether establishing

tolerances, exemptions from tolerances,

raising tolerance levels or expanding

exemptions might adversely impact

small entities and concluded, as a

generic matter, that there is no adverse

economic impact. The factual basis for

the Agency’s generic certification for

tolerance actions published on May 4,

1981 (46 FR 24950) and was provided

to the Chief Counsel for Advocacy of the

Small Business Administration.

VIII. Submission to Congress and the

General Accounting Office

Under 5 U.S.C. 801(a)(1)(A), as added

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted 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 General

Accounting Office prior to publication

of this rule in today’s Federal Register.

This 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 30, 1998.

Frank Sanders,

Director, Antimicrobials 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. 346a and 371.

2. Section 180.1196 is added to read

as follows:

§ 180.1196 Peroxyacetic acid; exemption

from the requirement of a tolerance.

An exemption from the requirement

of a tolerance is established for residues

of peroxyacetic acid up to 100 ppm in

or on raw agricultural commodities, in

processed commodities, when such

residues result from the use of

peroxyacetic acid as an antimicrobial

agent on fruits, tree nuts, cereal grains,

herbs, and spices.

[FR Doc. 98–12036 Filed 5–5–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300655; FRL–5789–4]

RIN 2070–AB78

Hydrogen Peroxide; Exemption From

the Requirement of a Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This document establishes an

exemption from the requirement of a
24956 Federal Register / Vol. 63, No. 87 /Wednesday, May 6, 1998 /Rules and Regulations

tolerance for residues of the

antimicrobial pesticide hydrogen

peroxide up to 120 ppm, in or on raw

agricultural commodities, in processed

commodities, when such residues result

from the use of hydrogen peroxide as an

antimicrobial agent on fruits, tree nuts,

cereal grains, herbs, and spices. Ecolab,

Inc. requested this exemption under the

Federal Food, Drug, and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996 (Pub. L. 104-170).

DATES: This regulation is effective May

6, 1998. Objections and requests for

hearings must be received by EPA on or

before July 6, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300655],

must be submitted to: Hearing Clerk

(1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

Branch, OPP (Tolerance Fees), P.O. Box

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing requests

filed with the Hearing Clerk identified

by the docket control number, [OPP–

300655], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 119, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

sending electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Copies of

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1/6.1 file

format or ASCII file format. All copies

of objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300655]. No Confidential Business

Information (CBI) should be submitted

through e-mail. Electronic copies of

objections and hearing requests on this

rule may be filed online at many Federal

Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: Marshall Swindell, Product

Manager 33, Antimicrobials Division

7510W, Office of Pesticide Programs,

Environmental Protection Agency,

401M St., SW., Washington, DC 20460.

Office location, telephone number, and

e-mail address: 2800 Crystal Drive, 6th

Floor, Arlington, VA, 22202, 703-308-

6341, e-mail:

swindell.marshall@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of January 14, 1998 (63

FR 2235) (FRL–5759–7), EPA, issued a

notice pursuant to section 408 of the

Federal Food, Drug, and Cosmetic Act

(FFDCA), 21 U.S.C. 346a(e) announcing

the filing of a pesticide petition (PP)

7F4834 for tolerance by Ecolab, Inc., 370

Wabasha Street, St. Paul, MN 55102.

This notice included a summary of the

petition prepared by Ecolab, Inc., the

registrant. There were no comments

received in response to the notice of

filing.

Subsequently, the proposed tolerance

exemption was amended to delete meat,

meat by-products, poultry, milk, and

eggs. This was done because at the low

proposed use concentrations, no

residues of toxicological concern are

expected on any animal feeds that may

be exposed to hydrogen peroxide.

Therefore, no residues of toxicological

concern are anticipated either in

animals that may consume these feeds,

or in associated animal by-products.

In addition, the proposed tolerance

exemption was amended to include a

maximum residue limit of 120 ppm for

hydrogen peroxide. This limitation was

added because of Agency concerns that

a high use concentration could result in

measurable residues of hydrogen

peroxide. Residue data will be needed

to increase or remove this limitation.

I. Risk Assessment and Statutory

Findings

New section 408(b)(2)(A)(i) of the

FFDCA allows EPA to establish a

tolerance or an exemption from the

requirement of a tolerance (the legal

limit for a pesticide chemical residue in

or on a food) only if EPA determines

that the tolerance or exemption from the

requirement of a 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 based primarily on

toxicological studies using laboratory

animals. These studies address many

adverse health effects, including (but

not limited to) reproductive effects,

developmental toxicity, toxicity to the

nervous system, and carcinogenicity.

Second, EPA examines exposure to the

pesticide through the diet (e.g., food and

drinking water) and through exposures

that occur as a result of pesticide use in

residential settings.

A. Toxicity

1. Threshold and non-threshold

effects. For many animal studies, a dose

response relationship can be

determined, which provides a dose that

causes adverse effects (threshold effects)

and doses causing no observed effects

(the ‘‘no-observed effect level’’ or

‘‘NOEL’’).

Once a study has been evaluated and

the observed effects have been

determined to be threshold effects, EPA

generally divides the NOEL from the

study with the lowest NOEL by an

uncertainty factor (usually 100 or more)

to determine the Reference Dose (RfD).

The RfD is a level at or below which

daily aggregate exposure over a lifetime

will not pose appreciable risks to

human health.

An uncertainty factor (sometimes

called a ‘‘safety factor’’) of 100 is

commonly used since it is assumed that

people may be up to 10 times more

sensitive to pesticides than the test

animals, and that one person or

subgroup of the population (such as

infants and children) could be up to 10

times more sensitive to a pesticide than

another. In addition, EPA assesses the

potential risks to infants and children

based on the weight of the evidence of

the toxicology studies and determines

whether an additional uncertainty factor

is warranted.

Thus, an aggregate daily exposure to

a pesticide residue at or below the RfD

(expressed as 100% or less of the RfD)

is generally considered acceptable by

EPA. EPA generally uses the RfD to

evaluate the chronic risks posed by

pesticide exposure. For shorter term

risks, EPA calculates a margin of

exposure (MOE) by dividing the

estimated human exposure into the

NOEL from the appropriate animal

study. Commonly, EPA finds MOEs

lower than 100 to be unacceptable. This

100-fold MOE is based on the same
Federal Register / Vol. 63, No. 87 /Wednesday, May 6, 1998 /Rules and Regulations 24957

rationale as the 100-fold uncertainty

factor.

Lifetime feeding studies in two

species of laboratory animals are

conducted to screen pesticides for

cancer effects. When evidence of

increased cancer is noted in these

studies, the Agency conducts a weight

of the evidence review of all relevant

toxicological data including short-term

and mutagenicity studies and structure

activity relationship. Once a pesticide

has been classified as a potential human

carcinogen, different types of risk

assessments (e.g., linear low dose

extrapolations or MOE calculation based

on the appropriate NOEL) will be

carried out based on the nature of the

carcinogenic response and the Agency’s

knowledge of its mode of action.

2. Differences in toxic effect due to

exposure duration. The toxicological

effects of a pesticide can vary with

different exposure durations. EPA

considers the entire toxicity data base,

and based on the effects seen for

different durations and routes of

exposure, determines which risk

assessments should be done to assure

that the public is adequately protected

from any pesticide exposure scenario.

Both short and long durations of

exposure are always considered.

Typically, risk assessments include

‘‘acute,’’ ‘‘short-term,’’ ‘‘intermediate

term,’’ and ‘‘chronic’’ risks. These

assessments are defined by the Agency

as follows.

Acute risk, by the Agency’s definition,

results from 1-day consumption of food

and water, and reflects toxicity which

could be expressed following a single

oral exposure to the pesticide residues.

High end exposure to food and water

residues are typically assumed.

Short-term risk results from exposure

to the pesticide for a period of 1-7 days,

and therefore overlaps with the acute

risk assessment. Historically, this risk

assessment was intended to address

primarily dermal and inhalation

exposure which could result, for

example, from residential pesticide

applications. However, since enaction of

the Food Quality Protection Act of 1996

(FQPA), this assessment has been

expanded to include both dietary and

non-dietary sources of exposure, and

will typically consider exposure from

food, water, and residential uses when

reliable data are available. In this

assessment, risks from average food and

water exposure, and high-end

residential exposure, are aggregated.

High-end exposures from all three

sources are not typically added because

of the very low probability of this

occurring in most cases, and because the

other conservative assumptions built

into the assessment assure adequate

protection of public health. However,

for cases in which high-end exposure

can reasonably be expected from

multiple sources (e.g. frequent and

widespread homeowner use in a

specific geographical area), multiple

high-end risks will be aggregated and

presented as part of the comprehensive

risk assessment/characterization.

Since the toxicological endpoint

considered in this assessment reflects

exposure over a period of at least 7 days,

an additional degree of conservatism is

built into the assessment; i.e., the risk

assessment nominally covers 1-7 days

exposure, and the toxicological

endpoint/NOEL is selected to be

adequate for at least 7 days of exposure.

(Toxicity results at lower levels when

the dosing duration is increased.)

Intermediate-term risk results from

exposure for 7 days to several months.

This assessment is handled in a manner

similar to the short-term risk

assessment.

Chronic risk assessment describes risk

which could result from several months

to a lifetime of exposure. For this

assessment, risks are aggregated

considering average exposure from all

sources for representative population

subgroups including infants and

children.

B. Aggregate Exposure

In examining aggregate exposure,

FFDCA section 408 requires that EPA

take into account available and reliable

information concerning exposure from

the pesticide residue in the food in

question, residues in other foods for

which there are tolerances, residues in

groundwater or surface water that is

consumed as drinking water, and other

non-occupational exposures through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses).

Dietary exposure to residues of a

pesticide in a food commodity are

estimated by multiplying the average

daily consumption of the food forms of

that commodity by the tolerance level or

the anticipated pesticide residue level.

The Theoretical Maximum Residue

Contribution (TMRC) is an estimate of

the level of residues consumed daily if

each food item contained pesticide

residues equal to the tolerance. In

evaluating food exposures, EPA takes

into account varying consumption

patterns of major identifiable subgroups

of consumers, including infants and

children.

The TMRC is a ‘‘worst case’’ estimate

since it is based on the assumptions that

food contains pesticide residues at the

tolerance level and that 100% of the

crop is treated by pesticides that have

established tolerances. If the TMRC

exceeds the RfD or poses a lifetime

cancer risk that is greater than

approximately one in a million, EPA

attempts to derive a more accurate

exposure estimate for the pesticide by

evaluating additional types of

information (anticipated residue data

and/or percent of crop treated data)

which show, generally, that pesticide

residues in most foods when they are

eaten are well below established

tolerances.

Percent of crop treated estimates are

derived from federal and private market

survey data. Typically, a range of

estimates are supplied and the upper

end of this range is assumed for the

exposure assessment. By using this

upper end estimate of percent of crop

treated, the Agency is reasonably certain

that exposure is not understated for any

significant sub-population group.

Further, regional consumption

information is taken into account

through EPA’s computer-based model

for evaluating the exposure of

significant sub-populations including

several regional groups, to pesticide

residues. For hydrogen peroxide, based

on the lack of any residues of

toxicological concern, it is unlikely that

significant exposure through the

proposed use would occur to any subpopulation although sensitive subpopulations may exist (eg.,catalase

deficient individuals).

II. Aggregate Risk Assessment and

Determination of Safety

Consistent with section 408(b)(2)(D),

EPA has reviewed the available

scientific data and other relevant

information in support of this action,

EPA has sufficient data to assess the

hazards of hydrogen peroxide and to

make a determination on aggregate

exposure, consistent with section

408(b)(2), for an exemption of a

requirement for a tolerance for residues

of hydrogen peroxide up to 120 ppm, in

or on raw agricultural commodities, in

processed commodities, when such

residues result from the use of hydrogen

peroxide as an antimicrobial agent on

fruits, tree nuts, cereal grains, herbs, and

spices. EPA’s assessment of the dietary

exposures and risks associated with

establishing the tolerance follows.

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered its validity,

completeness, and reliability as well as

the relationship of the results of the

studies to human risk. EPA has also

considered available information

concerning the variability of the
24958 Federal Register / Vol. 63, No. 87 /Wednesday, May 6, 1998 /Rules and Regulations

sensitivities of major identifiable

subgroups of consumers, including

infants and children. The nature of the

toxic effects caused by hydrogen

peroxide (H2O2) are discussed below.

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. Ecolab’s rationale for waivers

in each of these areas is similar, and are

summarized by the following four

arguments:

1. Available data at the Agency are

sufficient to estimate the potential

human health hazard of the end use

product.

2. Hydrogen peroxide is generally

recognized as safe (GRAS) according to

the Food and Drug Administration (21

CFR part 178) when used on foodprocessing equipment, utensils, and

food contact articles.

3. Based on the chemical reactivity of

this compound and its unstable nature,

conduct of long term or metabolism

studies would be extremely difficult and

unreliable.

4. The published Reregistration

Eligibility Document for Peroxy

Compounds (Case 4072, December,

1993), has waived all further toxicology

testing requirements for peroxy

compounds.

The Agency has reviewed the data

waivers requested and concurs that no

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

(i.e., 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 about 4

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 only at high concentrations, the

Agency is not concerned because of the

rapid decomposition of hydrogen

peroxide into oxygen and water.

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), dentrifices,

sanitary lotions, and pharmaceutical

preparations.

The long use history of hydrogen

peroxide and weight of empirical

evidence and experimental data has led

the FDA to put hydrogen peroxide on

the GRAS list when used on food

processing equipment, utensils, and

food contact articles (21 CFR 178).

Potential symptoms of acute

overexposure 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.

The following is a summary of the

existing generic data base for acute,

subchronic, chronic, mutagenic,

developmental, reproductive, and

carcinogenic effects of hydrogen

peroxide in mammalian test animals.

These data show that significant

toxicological effects of hydrogen

peroxide in mammalian test systems are

measurable only at high doses. The

proposed food contact use patterns are

not expected to result in residues of

toxicological concern due to the rapid

decomposition of hydrogen peroxide

into oxygen and water. The following

generic acute toxicology data for

hydrogen peroxide were cited in the

1993 RED for hydrogen peroxide. The

subchronic, chronic, carcinogenicity,

developmental, and reproductive

toxicology, along with the mutagenicity

data are summarized from the Office of

Water data base.

1. Acute studies— i. A study on mice

showed an acute oral LD50 of 2,000

milligrams/kilogram (mg/kg).

ii. A study on rats showed an acute

dermal LD50 of 4,060 mg/kg.

iii. A study on mice showed an acute

inhalation LC50 of 227 ul/L.

iv. An eye irritation study on rabbits

produced severe irritation.

v. A dermal irritation study on rabbits

showed hydrogen peroxide was

corrosive.

2. Subchronic exposure— i. Weanling

Osborne-Mendel rats were exposed to a

0.45% (560 mg/kg/day) aqueous

solution of hydrogen peroxide in

drinking water for 3 weeks. When

corrected for differences observed in

water intake between control and

treated rats, there were no significant

differences observed in absolute and

relative organ weights of the kidney,

spleen, heart, or testes. A NOEL of 560

mg/kg/day was determined, although a

lowest-observed-effect level (LOEL) was

not.

ii. Young male Holtzman rats were

administered doses of 0, 500, 1,000, or

1,500 mg/kg/day hydrogen peroxide in

water for 8 weeks. Increased mortality

was noted at the high dose. Increased

incidence of dental caries and

pathological changes in the

periodontium were also noted at the

mid and high dose. A LOEL of 500 mg/

kg/day was determined, but a NOEL was

not established.

iii. Male and female C57BL/6N, DBA/

2N, and BALB/cAnN mice were given

hydrogen peroxide at 0, 0.1, or 0.4% in

drinking water for 30 or 60 days.

Equivalent doses (assuming water intake

of 150 ml/kg/day) were 0, 150, or 600

mg/kg/day. The high dose resulted in

erosion of the glandular stomach in 29%

of mice treated for 30 days and in 40%

of mice treated for 60 days. Duodenal

lesions, but no frank nodules, were also

observed at the high dose. A LOEL of

600 mg/kg/day was determined, but due

to the lack of data reported at the 150

mg/kg/day dose, a NOEL could not be

definitively assigned.

3. Chronic exposure— i. Wistar rats

were administered 30 or 60 mg/kg/day

hydrogen peroxide for 100 days by oral

intubation. After 100 days, decreases in

plasma protein, hematocrit, and plasma

catalase were observed. Administration
Federal Register / Vol. 63, No. 87 /Wednesday, May 6, 1998 /Rules and Regulations 24959

of the same dose levels in feed had no

effects. A NOEL of 30 mg/kg/day could

be determined from this study.

ii. Three-week old mice (strain not

specified) were administered 0.15%

hydrogen peroxide in drinking water for

35 weeks, presumed equivalent to 150

mg/kg/day. Degenerative changes in the

liver and kidney, as well as

inflammation, irregularity and slight

necrosis of the stomach wall were

observed. The LOEL was determined to

be 150 mg/kg/day in this study, but a

NOEL was not identified.

iii. Male and female C57BL/6N mice

were administered 0, 0.1, or 0.4%

hydrogen peroxide in drinking water for

up to 700 days. Doses of 0, 150, and 600

mg/kg/day were calculated based on

assumed intake of 150 mL/kg/day water.

The gastrointestinal tract was examined

over the course of the study through

serial sacrifice at time points between

90-700 days. Gastric lesions consisting

of erosion and hyperplastic nodules

were detected in the stomach and

duodenum after 1-2 years exposure. The

LOEL was determined to be 150 mg/kg/

day from this study.

4. Carcinogenicity— i. Gastric

carcinogenesis was investigated in male

Wistar rats. Twenty-one rats received

the initiator MNNG in drinking water

for 8 weeks at 100 mg/L, while

uninitiated rats (10 animals) received

plain drinking water. After 8 weeks,

both groups received 1% hydrogen

peroxide in drinking water from week 8

through week 40. Two other groups (30

and 10 rats, respectively) were chosen

as initiated and uninitiated controls.

Surviving rats were sacrificed and

necropsied at 40 weeks. Erosion and

ulceration along the limiting ridge of the

fundic mucosa was observed. Initiated

rats showed an increased incidence of

adenomatous hyperplasia in this

stomach area. There were no

adenocarcinomas induced in the

stomach or duodenum. Papillomas of

the forestomach were induced by

hydrogen peroxide alone.

ii. Three month old Syrian hamsters

were administered either: twice weekly

applications of 30% hydrogen peroxide

in the left buccal pouch, twice weekly

buccal application of 0.25% 9,10

dimethyl-1,2-benzanthracene with

either 30% or 3% hydrogen peroxide

(hydrogen peroxide applied on a

different day than the DMBA), or DMBA

only. Buccal pouches were examined for

tumor development at 19 and 22 weeks

after sacrifice. No epidermoid

carcinomas were observed after 22

weeks of treatment with hydrogen

peroxide alone. All three groups

receiving DMBA treatment did develop

tumors. The tumors in the group

receiving the 30% hydrogen peroxide

and DMBA were reported to be more

anaplastic with deeper penetration of

tissue. It was concluded that hydrogen

peroxide may augment oral

carcinogenesis induced by DMBA.

iii. Male and female weanling C57Bl/

6J mice were administered 0, 0.1, or

0.4% hydrogen peroxide in drinking

water for up to 108 weeks. Erosion of

the glandular stomach was observed in

20% and 42% of dosed mice at the 0.1%

and 0.4% dose levels, respectively,

compared to 4% in controls. Duodenal

nodules were observed in treated mice

and were classified into hyperplasia,

adenoma, and carcinoma. Hyperplasia

was significantly increased at the 0.1%

and 0.4% dose levels (40% and 62% of

treated mice respectively), as was the

incidence of duodenal carcinoma,

observed in 5 of 99 high dose animals,

1 of 101 low dose animals, and absent

in controls.

iv. Various strains of mice (C57Bl/6N,

DBA/2N, BALB/c) were exposed to

0.4% hydrogen peroxide in drinking

water over their lifetime. Appearance of

duodenal lesions (plaques and nodules)

was noted in all strains after 90 days of

treatment. Temporary withdraw of

hydrogen peroxide produced apparent

reversibility in C57BL/6N mice only

after 30 days of no treatment. After 150

days of treatment, C57BL/6N mice

appeared to have an increased incidence

of duodenal lesions relative to the other

two strains. After 420-740 days of

treatment, the incidence of duodenal

carcinoma was 0, 1%, and 5% in

control, low, and high dose,

respectively. This study did not present

concurrent control data, and used

varying numbers of mice for

examination at the various time points.

Therefore, results from this study are

considered equivocal.

v. Strains of mice differing in catalase

activities of the duodenum, blood, and

liver (in order of decreasing activity:

C3H/HeN, B6C3F1, C57BL/6N, C3H/C)

were given a solution of 0.4% hydrogen

peroxide in drinking water for

approximately 6 months. The

duodenum was examined for the

incidence and total lesions in each

strain. Approximately 18-22 mice per

strain were examined. The data

suggested that the number of duodenal

lesions per mouse and total incidence

was inversely correlated wi th catalase

activity.

vi. Recent experimental evidence

(Upham, et al., Carcinogenesis 18(1): 37-

42, 1997) has implicated hydrogen

peroxide in the inhibition of gap

junctional intercellular communication

in rat liver epithelial cells (a significant

step in production of tumors). These

recent data lend support to the above

studies in the implication of high levels

of hydrogen peroxide as a promotor of

tumorigenesis. The International

Agency for Research in Cancer (IARC)

has designated hydrogen peroxide as

not classifiable as to carcinogenicity,

based on the data noted above.

5. Developmental and reproductive

toxicity. Three older studies on the

developmental and reproductive effects

of hydrogen peroxide are available.

These data indicate no apparent

developmental or reproductive effects

observed from administration of

hydrogen peroxide at concentrations up

to 1% (1000 mg/kg).

6. Mutagenicity— i. In a standard

plate incorporation assay, hydrogen

peroxide (concentrations not stated) was

weakly mutagenic to strains TA98,

TA97, and TA1537 for frame shift

mutations and to strain TA102 for

oxidative mutations, but was not

mutagenic to strains TA100 and

TA1538.

ii. Using isolated hepatocytes from

Female Fischer rats, hydrogen peroxide

was incubated at concentrations from

0.01 to 1.0mM for 1 hour at 37 degrees

Celsius. Overt cytotoxicity was observed

at 1mM. A concentration dependent

increase in single strand DNA breaks

was observed at all other exposure

levels. No double strand DNA breaks or

DNA cross-links were observed.

iii. In a human bronchial epithelial

cell system, nucleic acid synthesis was

observed to be significantly decreased

after exposure to hydrogen peroxide at

1.2mM for six hours followed by a cell

growth period of 7-9 days. At 100 m,

single strand DNA breaks and DNAprotein cross links were observed, with

single strand breaks predominating.

DNA strand breakage has also been

observed in other test systems (hamster

V79 cells and bovine pulmonary artery

and aortic endothelial cells).

iv. Cell killing and DNA damage were

examined in Chinese hamster fibroblast

cells (V79-379A). After incubation of

cells with 1-100 mM hydrogen peroxide

at ice cold temperatures for 10 or 20

minutes, single strand breaks were

observed at 1 mM hydrogen peroxide.

Double strand breaks and cell killing

were observed at higher (10mM)

concentrations of hydrogen peroxide.

B. Toxicological Endpoints

1. Acute toxicity. The Agency has

concluded that for the proposed food

contact uses, no apparent toxicity

endpoint exists to suggest any evidence

of significant toxicity from a one-day or

single-event exposure.

2. Short - and intermediate - term

toxicity. The Agency has concluded that
24960 Federal Register / Vol. 63, No. 87 /Wednesday, May 6, 1998 /Rules and Regulations

for the proposed food contact uses, no

apparent toxicity endpoint exists to

suggest any evidence of significant

toxicity from short and intermediate

term exposure.

3. Chronic toxicity. A RfD for

hydrogen peroxide has not been

established because of its short half life

and lack of any residues of toxicological

concern. As discussed in the December

1993 Reregistration Eligibility

Document for Peroxy Compounds, and

in this final rule, under the proposed

and existing dietary related use patterns

(i.e., raw and processed agricultural

commodities, food processing

equipment in breweries, wineries, and

beverage plants), there is expected to be

a lack of any residues of toxicological

concern.

4. Carcinogenicity. The Agency

believes that based on the known

chemistry of peroxy compounds, toxic

effects occur as a result of species

formed either during spontaneous

decomposition or enzymatic conversion

of the peroxy bond (i.e., O-O bond).

These effects occur only after long term

administration of high dose levels,

where the parent compound is

continually present. Available data

show that hydrogen peroxide rapidly

breaks down into oxygen and water.

Because of this rapid decomposition,

the Agency does not expect residues of

the parent compound on the treated

comodities.

Based on the proposed use

concentrations for hydrogen peroxide,

and data indicating a lack of residues of

concern 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 by the

rapid decomposition of hydrogen

peroxide into oxygen and water, which

are not of toxicological concern, and the

existence of specific enzymes in the

human body (i.e., catalase and

glutathione peroxidase) which also can

break down hydrogen peroxide.

C. Exposures and Risks

1. From food and feed uses. An

exemption from the requirement of a

tolerance is being established (40 CFR

180.1197) for the residues of hydrogen

peroxide) up to 120 ppm, in or on a

variety of (raw agricultural

commodities, in processed

commodities, when such residues result

from the use of hydrogen peroxide as an

antimicrobial agent on fruits, tree nuts,

cereal grains, herbs, and spices.

There are no existing food or feed use

tolerances or exemptions from the

requirement of a tolerance in title 40 of

the CFR for hydrogen peroxide. The

following 21 CFR tolerances and/or

exemptions from tolerances are noted:

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%).

Under 21 CFR 178.1010, hydrogen

peroxide is approved for use as a

sanitizing solution for use on food

processing equipment and utensils, and

on dairy processing equipment. It is also

approved for use in sterilizing

polymeric food-contact surfaces.

Under 21 CFR 173.315, hydrogen

peroxide is approved for use in washing

or to assist in the lye peeling of fruits

and vegetables.

Risk assessments were conducted by

EPA to assess dietary exposures and

risks from hydrogen peroxide as

follows:

i. Acute exposure and risk. 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 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.

ii. Chronic exposure and risk.

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.

2. From drinking water. Although the

proposed food contact uses for hydrogen

peroxide acid may result in transfer of

minor amounts of residues to potential

drinking water sources, no risk

assessment is warranted because of: (i)

the rapid degradation of hydrogen

peroxide into oxygen, and water, and

(ii) these degradates are not of

toxicological concern. Information from

the EPA Office of Water also indicates

that when used for potable water

disinfection, no residues of hydrogen

peroxyide acid are present by the time

the water is pumped through a

distribution system.

3. From non-dietary exposure.

Hydrogen peroxide is currently

registered by EPA for a wide variety of

uses including: agricultural premises

and equipment; food handling/storage

establishments premises and

equipment; commercial, institutional

and industrial premises and equipment;

residential and public access premises;

medical premises and equipment;

materials preservation; and 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, nondietary exposures are not expected to

pose any quantifiable added risk

because of a lack of any significant

residues of toxicological concern.

4. Cumulative exposure to substances

with common mechanism of toxicity.

Section 408(b)(2)(D)(v) requires that,

when considering whether to establish,

modify, or revoke a tolerance, the

Agency consider ‘‘available

information’’ concerning the cumulative

effects of a particular pesticide’s

residues and ‘‘other substances that

have a common mechanism of toxicity.’’

The Agency believes that ‘‘available

information’’ in this context might

include not only toxicity, chemistry,

and exposure data, but also scientific

policies and methodologies for

understanding common mechanisms of

toxicity and conducting cumulative risk

assessments. For most pesticides,

although the Agency has some

information in its files that may turn out

to be helpful in eventually determining

whether a pesticide shares a common

mechanism of toxicity with any other

substances, EPA does not at this time

have the methodologies to resolve the

complex scientific issues concerning
Federal Register / Vol. 63, No. 87 /Wednesday, May 6, 1998 /Rules and Regulations 24961

common mechanism of toxicity in a

meaningful way.

EPA has begun a pilot process to

study this issue further through the

examination of particular classes of

pesticides. The Agency hopes that the

results of this pilot process will increase

the Agency’s scientific understanding of

this question such that EPA will be able

to develop and apply scientific

principles for better determining which

chemicals have a common mechanism

of toxicity and evaluating the

cumulative effects of such chemicals.

The Agency anticipates, however, that

even as its understanding of the science

of common mechanisms increases,

decisions on specific classes of

chemicals will be heavily dependent on

chemical specific data, much of which

may not be presently available.

Although at present the Agency does

not know how to apply the information

in its files concerning common

mechanism issues to most risk

assessments, there are pesticides as to

which the common mechanism issues

can be resolved. These pesticides

include pesticides that are

toxicologically dissimilar to existing

chemical substances (in which case the

Agency can conclude that it is unlikely

that a pesticide shares a common

mechanism of activity with other

substances) and pesticides that produce

a common toxic metabolite (in which

case common mechanism of activity

will be assumed).

The Agency does not at this time have

data specifically either to support, or to

refute a common mechanism of toxicity

for peroxy compounds (i.e., hydrogen

peroxide, peroxyacetic acid). The

Agency believes that based on the

known common chemistry of peroxy

compounds, toxic effects occur as a

result of species formed either during

spontaneous decomposition or

enzymatic conversion of the peroxy

bond (i.e., O-O bond). These effects

occur only after long term

administration of high dose levels,

where the parent compound is

continually present. Although a

common mechanism of toxicity may or

may not be inferred, the Agency’s

concerns for cumulative risk is

mitigated by the lack of residues of the

parent compound (hydrogen peroxide)

at proposed use levels, and by the rapid

decomposition of the parent compound

into products which are not of

toxicological concern (i.e., oxygen and

water). As data become available, the

Agency may require further studies on

the peroxy compounds to determine

whether a cumulative risk assessment is

warranted.

EPA does not have, at this time,

available data to determine whether

hydrogen peroxide has a common

mechanism of toxicity with other

substances or how to include this

pesticide in a cumulative risk

assessment. Unlike other pesticides for

which EPA has followed a cumulative

risk approach based on a common

mechanism of toxicity, hydrogen

peroxide does not appear to produce

toxic metabolites. For the purposes of

this exemption from the requirement of

a tolerance, EPA has not assumed that

hydrogen peroxide has a common

mechanism of toxicity with other

substances.

D. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute, short- and intermediateterm risk. The Agency has concluded

that no endpoint exists to suggest any

evidence of significant toxicity from

acute, short term or intermediate term

exposures from the proposed food

contact uses of hydrogen peroxide.

Short- and intermediate-term aggregate

exposure takes into account chronic

dietary food and water (considered to be

a background exposure level) plus

indoor and outdoor residential

exposure.

The Agency concludes that there is a

reasonable certainty of no harm for

acute, short term, and intermediate risk

from aggregate exposure to hydrogen

peroxide under the proposed use

concentrations.

2. Chronic risk. Residues of hydrogen

peroxide are expected to dissociate

rapidly on the surface of materials

which it contacts. Therefore, the chronic

risk from dietary exposure is expected

to be negligible. No chronic exposure

and risk assessment is required 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 in air into oxygen

and water.

The Agency concludes that there is a

reasonable certainty of no harm for

chronic risk from aggregate exposure to

hydrogen peroxide under the proposed

use concentrations.

E. Aggregate Cancer Risk for U.S.

Population

Available data suggest that hydrogen

peroxide acts as a promoter of

carcinogenisis at relatively high doses

(in excess of 600 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 (i.e.,

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 (i.e.,

catalase and glutathione peroxidases)

for breakdown of hydrogen peroxide.

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.

F. Aggregate Risks and Determination of

Safety for Infants and Children

Safety factor 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

pre-and post-natal toxicity and the

completeness of the database, 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 MOE analysis

or through using uncertainty (safety)

factors 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 NOEL

in the animal study appropriate to the

particular risk assessment. This 100-fold

uncertainty factor/margin of exposure is

designed to account for inter-species
24962 Federal Register / Vol. 63, No. 87 /Wednesday, May 6, 1998 /Rules and Regulations

extrapolation and intra-species

variability.

In the case of the proposed food

contact uses for hydrogen peroxide,

because of the lack of any residues of

toxicological concern, a NOEL 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 conditions, no increased

susceptibility to infants or children is

expected to occur.

1. 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).

2. Hydrogen peroxide is highly

reactive and short lived because of the

inherent instability of the peroxide bond

(i.e., 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.

3. 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.

4. 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 Generally Recognized As

Safe (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 (i.e., 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.

III. Other Considerations

A. Endocrine Disruption

EPA is required to 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...’’ The Agency is currently

working with interested stakeholders,

including other government agencies,

public interest groups, industry and

research scientists in developing a

screening and testing program and a

priority setting scheme to implement

this program. Congress has allowed

three years from the passage of the

FQPA (August, 1999) to implement this

program. At that time, the EPA may

require further testing of this active

ingredient and end use products for

endocrine disrupter effects. There is no

current evidence to suggest that

hydrogen peroxide acts in a manner

similar to any known hormone or that

it acts as an endocrine disrupter.

B. Analytical Enforcement Methodology

Because an exemption from the

requirement of a tolerance is being

granted for hydrogen peroxide, an

enforcement analytical method is not

needed. However, an adequate

analytical method (designated QATM

202 by Ecolab, Inc., a redox titration

procedure) is available in the interim.

Because of the long lead time from

establishing a tolerance or exemption of

the requirement of a tolerance to

publication of the enforcement

methodology in the Pesticide Analytical

Manual., Volume II, the analytical

method is being made available to

anyone interested in pesticide

enforcement when requested from Norm

Cook, Antimicrobials Division (7510W),

Office of Pesticide Programs, US

Environmental Protection Agency, 401

M Street, SW., Washington, DC 20460.

Office location and telephone number:

2800 Crystal Drive, 6th Floor, Arlington,

VA 22202, 703-308-6411.

C. Magnitude of Residues

Residues of hydrogen peroxide are

short lived on treated crops and are not

expected to bioaccumulate in livestock

and/or poultry that consume treated

feedstuffs. Because of the lack of any

residues of toxicological concern, the

Agency has waived this data

requirement.

D. International Residue Limits

There are no Codex Alimentarius

Commission (Codex) Maximum Residue

Levels (MRLs) for hydrogen peroxide.

IV. Conclusion

Therefore, the exemption from the

requirement of a tolerance is established

for residues of hydrogen peroxide up to

120 ppm in or on raw agricultural

commodities, in processed

commodities, when such residues result

from the use of hydrogen peroxide as an

antimicrobial agent on fruits, tree nuts,

cereal grains, herbs, and spices.

It should be understood that the

Agency may take appropriate regulatory

action, and/or require the submission of

additional data to support the

exemption from the requirement of a

tolerance for hydrogen peroxide, if new

relevant adverse effects information

comes to the Agency’s attention.

V. Objections and Hearing Requests

The new FFDCA section 408(g)

provides essentially the same process

for persons to ‘‘object’’ to a tolerance

regulation issued by EPA under new

section 408(e) and (l)(6) as was provided

in the old section 408 and in section

409. However, the period for filing

objections is 60 days, rather than 30

days. EPA currently has procedural

regulations which govern the

submission of objections and hearing

requests. These regulations will require

some modification to reflect the new

law. However, until those modifications

can be made, EPA will continue to use

those procedural regulations with

appropriate adjustments to reflect the

new law.

Any person may, by July 6, 1998, file

written objections to any aspect of this

regulation and may also request a

hearing on those objections. Objections

and hearing requests must be filed with

the Hearing Clerk, at the address given

above (40 CFR 178.20). A copy of the

objections and/or hearing requests filed

with the Hearing Clerk should be

submitted to the OPP docket for this

rulemaking. The objections submitted

must specify the provisions of the

regulation deemed objectionable and the

grounds for the objections (40 CFR

178.25).

Each objection must be accompanied

by the fee prescribed by 40 CFR

180.33(i). If a hearing is requested, the

objections must include a statement of

the factual issues on which a hearing is

requested, the requestor’s contentions

on such issues, and a summary of any

evidence relied upon by the requestor

(40 CFR 178.27).

A request for a hearing will be granted

if the Administrator determines that the
Federal Register / Vol. 63, No. 87 /Wednesday, May 6, 1998 /Rules and Regulations 24963

material submitted shows the following:

There is 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 in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

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.

VI. Public Docket

EPA has established a record for this

rulemaking under docket control

number [OPP–300655] (including any

comments and data submitted

electronically). A public version of this

record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as CBI, is available for

inspection from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays.

The public record is located in Room

119 of the Public Information and

Records Integrity Branch, Information

Resources and Services Division

(7502C), Office of Pesticide Programs,

Environmental Protection Agency,

Crystal Mall #2, 1921 Jefferson Davis

Hwy., Arlington, VA.

Electronic comments may be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

VII. Regulatory Assessment

Requirements

This final rule establishes an

exemption from the requirement of a

tolerance 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)

(Pub. L. 104–4). Nor does it require any

prior consultation as specified by

Executive Order 12875, entitled

Enhancing the Intergovernmental

Partnership (58 FR 58093, October 28,

1993), or 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 in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

Risks (62 FR 19885, April 23, 1997).

In addition, since these 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.

Nevertheless, the Agency has previously

assessed whether establishing

tolerances, exemptions from tolerances,

raising tolerance levels or expanding

exemptions might adversely impact

small entities and concluded, as a

generic matter, that there is no adverse

economic impact. The factual basis for

the Agency’s generic certification for

tolerance actions published on May 4,

1981 (46 FR 24950) and was provided

to the Chief Counsel for Advocacy of the

Small Business Administration.

VIII. Submission to Congress and the

General Accounting Office

Under 5 U.S.C. 801(a)(1)(A), as added

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted 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 General

Accounting Office prior to publication

of this rule in today’s Federal Register.

This 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 30, 1998.

Frank Sanders,

Director, Antimicrobials 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. 346a and 371.

2. Section 180.1197 is added to read

as follows:

§ 180.1197 Hydrogen peroxide; exemption

from the requirement of a tolerance.

An exemption from the requirement

of a tolerance is established for residues

of hydrogen peroxide up to 120 ppm in

or on raw agricultural commodities, in

processed commodities, when such

residues result from the use of hydrogen

peroxide as an antimicrobial agent on

fruits, tree nuts, cereal grains, herbs, and

spices.

[FR Doc. 98–12037 Filed 5–5–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 261 and 279

[FRL–5969–4]

Hazardous Waste Management

System; Identification and Listing of

Hazardous Waste; Recycled Used Oil

Management Standards

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Direct final rule.

SUMMARY: Today’s direct final rule

eliminates errors and clarifies

ambiguities in the used oil management

standards. Specifically, this rule

clarifies when used oil contaminated

with polychlorinated biphenyls (PCBs)

is regulated under the used oil

management standards and when it is

not, that the requirements applicable to

releases of used oil apply in States that