Federal Register / Vol. 63, No. 87 /Wednesday, May 6, 1998 /Rules and Regulations 24949

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 the rule in

the Federal Register. This rule is not a

‘‘major rule’’ as defined by 5 U.S.C.

804(2).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: April 22, 1998.

Stephen L. Johnson,

Acting Director, 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 180.503 is amended by

adding text to paragraph (a) to read as

follows and by removing the entry for

‘‘potatoes’’ in paragraph (b) .

§ 180.503 Cymoxanil; tolerances for

residues.

(a) General . A tolerance is established

for residues of the fungicide, cymoxanil,

2-cyano-N-[(ethylamino)carbonyl]-2-

(methoxyimino) acetamide, in or on the

following food commodity.

Commodity Parts per million

Potatoes ............................... 0.05

* * * * *

[FR Doc. 98–11764 Filed 5–5–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300654; FRL–5789–3]

RIN 2070–AB78

Peroxyacetic Acid; 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

tolerance for residues of the

antimicrobial pesticide 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. 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–300654],

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–

300654], 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–

300654]. 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, 401

M 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 2232) (FRL–5759–6), 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)

7F4808 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 peroxyacetic acid.

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 100 ppm for

peroxyacetic acid. This limitation was

added because of Agency concerns that

a high use concentration could result in

measurable residues of peroxyacetic

acid. 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
24950 Federal Register / Vol. 63, No. 87 /Wednesday, May 6, 1998 /Rules and Regulations

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

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
Federal Register / Vol. 63, No. 87 /Wednesday, May 6, 1998 /Rules and Regulations 24951

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 peroxyacetic acid, 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 peroxyacetic acid 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 peroxyacetic acid up to 100 pm, 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. 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

sensitivities of major identifiable

subgroups of consumers, including

infants and children. The nature of the

toxic effects caused by peroxyacetic acid

(C2H4O3) are discussed below.

Ecolab, Inc. has requested a waiver of

all toxicology testing requirements for

peroxyacetic acid. This includes

waivers for all acute, 90-day subchronic, chronic, carcinogenicity,

developmental, reproductive,

mutagenicity, neurotoxicity and

metabolism requirements. 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. Peroxyacetic acid reacts rapidly on

contact with material such as food and

is degraded to moieties which present

no toxicological concern. The primary

degradation products of peroxyacetic

acid are acetic acid, which is generally

regarded as safe (GRAS) according to the

Food and Drug Administration (21 CFR

184.1005), water, and oxygen.

Based on the chemical reactivity of

this compound and the unstable nature

of the peroxide bond, conduct of long

term residue or metabolism studies

would be extremely difficult and

unreliable. This peroxyacetic acid

petition is also the companion to a

similar tolerance petition being ruled on

for hydrogen peroxide. Peroxyacetic

acid and hydrogen peroxide are

classified as peroxy compounds and

have similar characteristics for

degradation, residue chemistry, doserelationship toxicology, and risk of

exposure with the proposed food

contact uses.

The published Reregistration

Eligibility Document for Peroxy

Compounds (Case 4072, December,

1993), has waived all further toxicology

testing requirements for peroxyacetic

acid.

The Agency has reviewed the data

waivers requested and concurs that no

additional acute short term or long term

toxicology or mutagenicity testing will

be needed for peroxyacetic acid for the

following reasons.

1. Peroxyacetic acid 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 can accelerate decomposition.

The instability of peroxyacetic acid to

exist as itself, along with detoxifying

enzymes found in cells (eg., catalase,

glutathione peroxidase), makes it very

difficult to find any residues of

peroxyacetic acid in or on foods (at the

proposed use levels), by conventional

analytical methods.

The proposed food contact

applications utilize very low

concentrations of peroxyacetic acid.

Therefore, food residues produced by

the proposed uses are expected to be

short-lived, based on half-lives for

peroxyacetic acid which can be as short

as a few minutes. The primary

degradates are acetic acid, oxygen, and

water, and these degradates are not of

toxicological concern.

2. There are acceptable acute generic

data referenced in the Reregistration

Eligibility Document for Peroxy

Compounds (December 1993, Case

4072). Peroxyacetic acid was found to

be corrosive and severely irritating to

the eyes, skin, and mucous membranes

but only when high concentrations were

used. The proposed food contact use

patterns are not expected to result in

any residue levels of toxicological

concern. The RED document waived all

additional non-acute toxicology data

requirements for peroxyacetic acid.

3. No data exists for the subchronic,

chronic, carcinogenicity, mutagenicity,

developmental and reproductive

toxicity of peroxyacetic acid. However,

peroxyacetic acid shares similar

chemical characteristics with hydrogen

peroxide which has a more extensive

toxicology data base. For example,

peroxyacetic acid and hydrogen

peroxide both decompose into two

identical degradates that do not pose

any toxicological concern. These two

degradates are oxygen and water. Acetic

acid is the third additional residue

degradate of peroxyacetic acid which

also does not pose any toxicological

concern.

Peroxyacetic acid and hydrogen

peroxide also show similar chemical

characteristics for corrosivity, pH, rapid

peroxide bond dissociation, and

production of oxygen molecules.

Because of these similar chemical

characteristics, and low expected

exposures with the proposed uses, the

dose-response toxicology relationships

(i.e., adverse effects experienced only at

very high doses) shown by the data for

hydrogen peroxide, can also be expected

with peroxyacetic acid. The remaining

toxicology testing requirements for

peroxyacetic acid were waived because

of the similar chemical characteristics,

similar expected dose-response

relationships with hydrogen peroxide,

low exposure levels under the proposed

uses, and for the reasons given above.
24952 Federal Register / Vol. 63, No. 87 /Wednesday, May 6, 1998 /Rules and Regulations

The following generic acute

toxicology data for peroxyacetic acid

were cited in the 1993 RED document.

Acute studies for peroxyacetic acid—

i. A study on rats showed an acute oral

LD50 of 1,540 milligrams/kilogram (mg/

kg).

ii. A study on rabbits showed an acute

dermal LD50 of 1,410 mg/kg.

iii. A study on rats showed an acute

inhalation LC50 of 0.450 mg/L.

iv. An eye irritation study on rabbits

produced severe irritation.

v. A dermal irritation study on rabbits

showed hydrogen peroxide was

corrosive.

B. Toxicological Endpoints

1. Acute toxicity. The Agency has

concluded that with the proposed food

contact uses of peroxyacetic acid, 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

for the proposed food contact uses of

peroxyacetic acid, based on the

similarity and commonality in the

peroxide bond chemistry, residues,

degradates, and also with the doseresponse relationships with hydrogen

peroxide, no apparent toxicity endpoint

would be expected from short and

intermediate term exposure.

3. Chronic toxicity. A RfD for

peroxyacetic acid has not been

established because of its short half life

and lack of any residues and degradates

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

also expected to be a lack of any

residues and degradates 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 peroxyacetic acid rapidly

breaks down into oxygen, water, and

acetic acid. 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 peroxyacetic acid,

and data indicating a lack of residues of

concern on food, exposure to

peroxyacetic acid 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 peroxyacetic acid into oxygen, water,

and acetic acid, 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

peroxyacetic acid.

C. Exposures and Risks

1. From food and feed uses. An

exemption from the requirement of a

tolerance is being established (40 CFR

180.1196) for the residues of

peroxyacetic acid) up to 100 ppm, in or

on a variety of (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.

There are no existing tolerances or

exemptions from tolerances in title 40 of

the CFR for peroxyacetic acid for direct

food and feed contact uses. The

following 21 CFR tolerances and/or

exemptions from tolerances are noted:

Under 21 CFR 184.1005, the acetic

acid degradate of peroxyacetic acid is

GRAS as a direct food additive

substance when used in baked goods,

cheeses, dairy product analogs, chewing

gum, condiments, relishes, fats, oils,

gravies, sauces, and meat products.

Under 21 CFR 178.1010, peroxyacetic

acid 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, peroxyacetic acid 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 peroxyacetic acid 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 for peroxyacetic acid because

no acute toxicological effects of concern

are anticipated with the proposed food

contact uses for peroxyacetic acid. This

is due to the lack of any residues of

toxicological concern as a result of the

rapid decomposition of peroxyacetic

acid into acetic acid, oxygen, and water.

ii. Chronic exposure and risk.

Residues of peroxyacetic acid 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

peroxyacetic acid. This is due to the

lack of any residues of toxicological

concern as a result of the rapid

decomposition of peroxyacetic acid into

acetic acid, oxygen, and water.

2. From drinking water. Although the

proposed food contact uses for

peroxyacetic acid may result in transfer

of peroxyacetic acid to potential

drinking water sources, no risk

assessment is applicable because of: (a)

the rapid degradation of peroxyacetic

acid into acetic acid, oxygen, and water,

and (b) there are not expected to be any

residues of toxicological concern.

Information from the EPA Office of

Water also indicates that when used for

potable water disinfection, no

measurable residues of peroxyacetic

acid were present by the time the water

is pumped through the distribution

system and arrived at the tap.

3. From non-dietary exposure.

Peroxyacetic acid 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. The

Agency does not know of all approved

or actual uses for peroxyacetic acid.

However, non-dietary exposures are not

expected to pose any quantifiable added

risk because of the lack of any expected

residues and degradates of toxicological

concern. Minimal residues and

degradates are expected due to

previously discussed unique chemistry

associated with peroxide bond

chemistry.

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.’’
Federal Register / Vol. 63, No. 87 /Wednesday, May 6, 1998 /Rules and Regulations 24953

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

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 any measurable

residues of the parent compound

(peroxyacetic acid) 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.

The Agency does not have, at this

time, available data to determine

whether peroxyacetic acid shares a

common mechanism of toxicity with

other substances or how to include this

pesticide in a cumulative risk

assessment. For the purposes of this

tolerance action, EPA has not assumed

that peroxyacetic acid has a common

mechanism of toxicity with other

substances.

D. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute, short term and intermediate

risk. The Agency has concluded that no

toxicological endpoint exists for

peroxyacetic acid with the proposed

food contact uses to suggest any

evidence of significant toxicity from

acute, short term or intermediate term

exposures. 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 peroxyacetic

acid under the proposed use

concentrations.

2. Chronic risk. Low residues of

peroxyacetic acid are expected from the

proposed food contact uses and these

residues are expected to convert rapidly

into the harmless degradates of acetic

acid, oxygen, and water. Therefore, the

chronic 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

peroxyacetic acid.

The Agency concludes that there is a

reasonable certainty of no harm for

chronic risk from aggregate exposure to

peroxyacetic acid under the proposed

use concentrations.

E. Aggregate Cancer Risk for U.S.

Population

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 peroxyacetic acid rapidly

breaks down into oxygen, water, and

acetic acid. Because of this rapid

decomposition, the Agency does not

expect residues of the parent compound

on the treated commodities.

Based on the proposed use

concentrations for peroxyacetic acid,

and data indicating a lack of residues of

concern on food, exposure to

peroxyacetic acid 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 peroxyacetic acid into oxygen, water,

and acetic acid, 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

peroxyacetic acid.

The Agency concludes that cancer

cancer risk for the U.S. population from

aggregate exposure to peroxyacetic acid

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 peroxyacetic acid, EPA

considered data from developmental

and reproductive toxicity studies

available on hydrogen peroxide 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
24954 Federal Register / Vol. 63, No. 87 /Wednesday, May 6, 1998 /Rules and Regulations

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

extrapolation and intra-species

variability.

In the case of the proposed food

contact uses for peroxyacetic acid,

because of the lack of any significant

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

peroxyacetic acid. For the same reason,

an additional safety factor to protect

infants and children is unnecessary.

Additionally, based on the following

information, no increased susceptibility

to infants or children is expected to

occur.

1. Three studies on the developmental

and reproductive effects of hydrogen

peroxide (and by similarity,

peroxyacetic acid) 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. Peroxyacetic acid is a highly

reactive and short lived molecule

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 dissociation. The instability

of peroxyacetic acid to exist as itself,

along with natural detoxifying enzymes

found in plant and animal cells (eg.,

catalase, glutathione peroxidase), makes

it very difficult to find any residues of

peroxyacetic acid in or on foods (at

proposed use levels), by conventional

analytical methods. The proposed food

contact applications utilize very low

concentrations of peroxyacetic acid (

ppm). Food residues are expected to be

short-lived and are not expected to

accumulate. This is because

peroxyacetic acid dissociates rapidly

into acetic acid, oxygen, and water. The

Agency has no toxicological concern

with acetic acid, 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.

Therefore, because of the rapid

decomposition of peroxyacetic acid

residues into degradates that are of no

toxicological concern (i.e., oxygen,

water, acetic acid), the Agency

concludes that there is a reasonable

certainty of no harm for infants and

children from exposure to peroxyacetic

acid 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

peroxyacetic acid 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 peroxyacetic acid, an

enforcement analytical method is not

needed. However, an adequate

analytical method (called 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, U.S.

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 peroxyacetic acid 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 peroxyacetic acid.

IV. Conclusion

Therefore, the 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.

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 peroxyacetic acid, 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
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