75168 Federal Register / Vol. 65, No. 232 / Friday, December 1, 2000 / Rules and Regulations

the transitional provisions. Based on its

review, the Postal Service has

determined to adopt the proposed

changes without revision. As of January

1, 2001, the DMM is revised to eliminate

the transitional accommodation to

mailers with stationery bearing obsolete

ancillary service endorsements.

DMM F030.1.2 is revised to provide

ancillary services only in accordance

with the valid endorsements shown in

DMM F010. Mail bearing obsolete,

invalid, or conflicting ancillary service

endorsements will no longer be

considered acceptable for mailing and

the Postal Service may refuse to accept

this mail. If mail bearing invalid or

conflicting endorsements is discovered

in the mailstream it will be handled as

unendorsed mail. In the case of

Standard Mail (B), ‘‘treatment as

unendorsed mail’’ effectively means that

mail will be treated as if endorsed

‘‘Forwarding Service Requested.’’ This

provision recognizes that the general

public (in contrast with business

mailers) is unfamiliar with ancillary

service endorsements and ensures that

packages will be delivered or returned.

Comments Received

The Postal Service received two

comments on the proposed rule. One

comment was from an importer of

material for domestic entry, and the

other from an individual customer.

The importer was concerned that mail

bearing invalid or conflicting ancillary

service endorsements would not be

accepted for mailing, potentially

creating a disadvantage for the importer,

relative to foreign postal

administrations, who enter mail in

accordance with international postal

conventions. Mailers who import

material for domestic entry to the

United States Postal Service, for the

services, benefits, and opportunities that

arrangement presents, must comply

with domestic mailing requirements.

Exceptions based on the origin or

particular qualities of matter that is

mailed domestically are not permitted.

Commercial mailers are expected to

communicate applicable DMM

requirements to their clients and ensure

the mailability of material intended for

domestic entry. International mail

received from foreign postal

administrations is subject to the

provisions of the Universal Postal

Convention. The provisions of this

agreement are different than domestic

procedures and requirements and are

generally binding on the Postal Service,

which is signatory to the Convention.

Changes to international mailing

conditions must generally be negotiated

and require amendment of multilateral

conventions and agreements.

Modifications to the conditions for entry

of international mail are not being

considered at this time.

The individual customer comment

concerned the lost value of stationery

bearing obsolete or invalid

endorsements and the treatment of

items deposited in mail collection boxes

which enter the mailstream and are

therefore considered ‘‘accepted.’’ The

proposed rule was asserted to be

‘‘discriminatory,’’ since improperly

prepared mail that is presented to an

employee could be refused, while mail

deposited in a collection box can remain

in the mailstream and be treated as

unendorsed mail.

Mailers have had an extended period

of time to adopt correct ancillary service

endorsements. Residual stationery

inventory can be used if obsolete

endorsements are obliterated,

minimizing any hardship. Otherwise,

acceptance employees routinely reject

improperly prepared mail or require

customers to correct irregularities. The

fact that improperly prepared items may

enter the mailstream through unstaffed

collection points reflects the

practicalities of providing convenient

and universal access to the postal

network and is not discriminatory. The

final rule simply requires the proper

endorsement of mail for which an

ancillary service is desired and

terminates the transitional provisions

for servicing invalid endorsements.

For the reasons discussed above, the

Postal Service adopts the following

amendments to the Domestic Mail

Manual, which is incorporated by

reference in the Code of Federal

Regulations (see 39 CFS 111).

List of Subjects in 39 CFR Part 111

Administrative practice and

procedure, Postal Service.

PART 111—[AMENDED]

1. The authority citation for 39 CFR

part 111 continues to read as follows:

Authority: 5 U.S.C. 552(a); 39 U.S.C. 101,

401, 403, 404, 414, 3001–3011, 3201–3219,

3403–3406, 3621, 3626, 5001.

2. Revise the Domestic Mail Manual

(DMM) as follows:

F Forwarding and Related Services

F000 Basic Services

* * * * *

F030 Address Correction, Address

Change, FASTforward, and Return

Services

1.0 ADDRESS CORRECTION SERVICE

* * * * *

1.2 Invalid Endorsement

Any obsolete ancillary service

endorsement or similar sender

endorsement not shown in F010 is

considered invalid. Material bearing

invalid or conflicting ancillary service

endorsements will not be accepted for

mailing. If discovered in the mailstream,

mail bearing an invalid ancillary service

endorsement or conflicting

endorsements is treated as unendorsed

mail. Exception: Standard Mail (B)

pieces that are unendorsed, or that bear

invalid or conflicting ancillary service

endorsements and are undeliverable,

will be treated as if endorsed

‘‘Forwarding Service Requested.’’

This change will be published in a

future issue of the Domestic Mail

Manual. An appropriate amendment to

39 CFR 111.3 to reflect these changes

will be published.

Stanley F. Mires,

Chief Counsel, Legislative.

[FR Doc. 00–30581 Filed 11–30–00; 8:45 am]

BILLING CODE 7710–12–U

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301068; FRL–6748–6]

RIN 2070–AB78

Peroxyacetic Acid; Exemption From

the Requirement of a Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes an

exemption from the requirement of a

tolerance for residues of peroxyacetic

acid, in or on all raw and processed

food commodities when used in

sanitizing solutions containing a diluted

end-use concentration of peroxyacetic

acid up to 500 ppm, and applied to

tableware, utensils, dishes, pipelines,

tanks, vats, fillers, evaporators,

pasteurizers, aseptic equipment, milking

equipment, and other food processing

equipment in food handling

establishments including, but not

limited to dairies, dairy barns,

restaurants, food service operations,

breweries, wineries, and beverage and

food processing plants. Ecolab,

Incorporated submitted a petition to

EPA under the Federal Food, Drug, and

Cosmetic Act, as amended by the Food

Quality Protection Act of 1996

requesting an exemption from the

requirement of a tolerance. This

regulation eliminates the need to

Federal Register / Vol. 65, No. 232 / Friday, December 1, 2000 / Rules and Regulations 75169

establish a maximum permissible level

for residues of peroxyacetic acid. This

final rule amends the current

peroxyacetic acid exemption; and adds

the subject peroxyacetic acid

exemption. This final rule is being

published with a companion final rule

titled ‘‘Hydrogen Peroxide; Exemption

From the Requirement of a Tolerance.’’

DATES: This regulation is effective

December 1, 2000. Objections and

requests for hearings, identified by

docket control number OPP–301068,

must be received by EPA on or before

January 30, 2001.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, in person, or by courier. Please

follow the detailed instructions for each

method as provided in Unit VIII. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301068 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Marshall Swindell, Product

Manager 33, Antimicrobial Division

(7510C), Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: 703 308–

6341; e-mail address:

swindell.marshall@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer, or pesticide

manufacturer. Potentially affected

categories and entities may include, but

are not limited to:

Categories NAICS

codes

Examples of potentially affected

entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations’’ ‘‘Regulations

and Proposed Rules,’’ and then look up

the entry for this document under the

‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–301068. The official record

consists of the documents specifically

referenced in this action, and other

information related to this action,

including any information claimed as

Confidential Business Information (CBI).

This official record includes the

documents that are physically located in

the docket, as well as the documents

that are referenced in those documents.

The public version of the official record

does not include any information

claimed as CBI. The public version of

the official record, which includes

printed, paper versions of any electronic

comments submitted during an

applicable comment period is available

for inspection in the Public Information

and Records Integrity Branch (PIRIB),

Rm. 119, Crystal Mall #2, 1921 Jefferson

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

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

excluding legal holidays. The PIRIB

telephone number is (703) 305–5805.

II. Background and Statutory Findings

In the Federal Register of February 3,

1999 (64 FR 22) (FRL–5273–7), EPA

issued a notice pursuant to section 408

of the Federal Food, Drug, and Cosmetic

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

amended by the Food Quality Protection

Act (FQPA) (Public Law 104–170)

announcing the filing of a pesticide

tolerance petition by, Ecolab,

Incorporated. This notice included a

summary of the petition prepared by the

petitioner Ecolab, Incorporated. There

were no comments received in response

to the notice of filing.

The petition requested that 40 CFR

180.1196 be amended by establishing an

exemption from the requirement of a

tolerance for residues of peroxyacetic

acid.

III. Risk Assessment

Section 408(b)(2)(A)(i) of the FFDCA

allows EPA to establish an exemption

from the requirement for a tolerance (the

legal limit for a pesticide chemical

residue in or on a food) only if EPA

determines that the tolerance is ‘‘safe.’’

Section 408(b)(2)(A)(ii) defines ‘‘safe’’ to

mean that ‘‘there is a reasonable

certainty that no harm will result from

aggregate exposure to the pesticide

chemical residue, including all

anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

408(b)(2)(C) requires EPA to give special

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue....’’

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides. Second, EPA examines

exposure to the pesticide through food,

drinking water, and through other

exposures that occur as a result of

pesticide use in residential settings.

IV. Toxicological Profile

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

of FFDCA, EPA has reviewed the

available scientific data and other

relevant information in support of this

action and considered its validity,

completeness and reliability and the

relationship of this information to

human risk. EPA has also considered

available information concerning the

variability of the sensitivities of major

identifiable subgroups of consumers,

including infants and children. The

nature of the toxic effects caused by

peroxyacetic acid are discussed in this

unit.

Ecolab, Inc. has requested a waiver of

all toxicology testing requirements for

peroxyacetic acid. This includes

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

developmental, reproductive,

mutagenicity, neurotoxicity and

metabolism requirements for

peroxyacetic acid. The Agency has

reviewed the data waivers requested

and concurs that no additional generic

toxicology testing will be needed for

75170 Federal Register / Vol. 65, No. 232 / Friday, December 1, 2000 / Rules and Regulations

peroxyacetic acid for the following

reasons.

1. Peroxyacetic acid is highly reactive

and short lived because of the inherent

instability of the peroxide bond (ie., the

O-O bond). Agitation or contact with

rough surfaces, sunlight, organics and

metals accelerates decomposition. The

instability of 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

proposed use levels), by conventional

analytical methods.

The proposed food contact

applications also utilize very low

concentrations of peroxyacetic acid.

Therefore, food residues are expected to

be short-lived, based on half-lives for

peroxyacetic acid as short as a few

minutes under certain conditions. 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 (RED) 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 use patterns involve

low concentrations and are expected to

result in a lack of any residues of

toxicological concern. The RED

document waived all other 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 also a degradate of peroxyacetic

acid and 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.

V. Aggregate Exposures

A. Dietary Exposure

1. Food. For the proposed sanitizer

uses, the 15.2% (by weight) concentrate

of peroxyacetic acid will be diluted with

potable water at the rate of 1 to 1.8

ounces of concentrated product per

1,024 ounces (8 gallons) of dilution

water for food contact surfaces (eg., food

packaging equipment), and for eating,

drinking, and food preparation utensils.

For low temperature (120 degrees F)

tableware sanitization in warewashing

machines, the dilution rate is 1 ounce of

concentrated product per 3,840 ounces

(30 gallons) of dilution water.

These dilution rates correspond to a

low concentration range of peroxyacetic

acid in the sanitizer product at the time

of application of 40 to 274 ppm. The

sanitizer solution, having a low

concentration of peroxyacetic acid

reacts on contact with the surface on

which it is applied and degrades rapidly

to acetic acid, oxygen and water which

pose no toxicological concern.

Therefore, residues of peroxyacetic acid

resulting from its use in sanitizer

solutions up to 500 ppm are expected to

be negligible on all raw and processed

food commodities. The difference

between the 274 ppm maximum end use

concentration, and the 500 ppm

exemption concentration requested by

Ecolab, is warranted to overcome any

degradation of peroxyacetic acid during

transport and non-use periods, and to

provide flexibility for changes in

formulation.

The following EPA and FDA

tolerances and/or exemptions from

tolerances for peroxyacetic acid are

noted:

Under 40 CFR 180.1196 as a direct

application at 100 ppm to fruits,

vegetables, tree nuts, cereal grains, herbs

and spices.

Under 21 CFR 178.1010(b)(30) for

sanitizing solutions used on foodprocessing equipment and utensils and

on other food contact articles. Sanitizing

solutions may contain not less than 100

ppm nor more than 200 ppm

peroxyacetic acid as per 21 CFR

178.1010(c)(25).

Under 21 CFR 178.1010(b)(38) for

sanitizing solutions used on food

processing equipment and dairy

processing equipment. Sanitizing

solutions may contain not less than 200

ppm nor more than 315 ppm as per 21

CFR 178.1010(c)(33).

Under 21 CFR 173.315(a)(2) in

washing or to assist in lye peeling of

fruits and vegetables that are not raw

agricultural commodities. The

concentration can not exceed 80 ppm in

the wash water.

In 21 CFR 184.1005, the acetic acid

degradate of peroxyacetic acid is

Generally Recognized As Safe (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.

2. Drinking Water Exposure. The

proposed indoor food contact uses for

peroxyacetic acid are not expected to

result in transfer of peroxyacetic acid to

any potential drinking water sources.

Therefore, no risk assessment is

warranted.

B. Other Non-Occupational 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.

VI. Cumulative Effects

The Food Quality Protection Act

(1996) stipulates that when determining

the safety of a pesticide chemical, EPA

shall consider, among other things,

available information concerning the

cumulative effects to human health that

may result from dietary, residential, or

other non-occupational exposure to

other substances that have a common

mechanism of toxicity. The reason for

consideration of other substances is due

to the possibility that low-level

exposures to multiple chemical

substances that cause a common toxic

effect by a common mechanism could

lead to the same adverse health effect as

would a higher level of exposure to any

of the other substances individually. A

person exposed to a pesticide at a level

Federal Register / Vol. 65, No. 232 / Friday, December 1, 2000 / Rules and Regulations 75171

that is considered safe may in fact

experience harm if that person is also

exposed to other substances that cause

a common toxic effect by a mechanism

common with that of the subject

pesticide, even if the individual

exposure levels to the other substances

are also considered safe.

Because of the low use rates of

peroxyacetic acid, its low toxicity and

rapid degradation, EPA does not believe

that there are any concerns regarding

the potential for cumulative effects of

peroxyacetic acid with other substances,

due to a common mechanism of action.

Peroxyacetic acid is not known to have

a common toxic metabolite with other

substances. Therefore, EPA has not

assumed that peroxyacetic acid has a

common mechanism of toxicity with

other substances.

VII. Determination of Safety for U.S.

Population, Infants and Children

Peroxyacetic acid is of low toxicity,

and the proposed uses employ low

concentrations. Because of the low

toxicity and rapid degradation of

peroxyacetic acid following application,

EPA concludes that this exemption from

the requirement of a tolerance in or on

all raw and processed food

commodities, when peroxyacetic acid is

used in diluted sanitizing solutions up

to 500 ppm, will not pose a dietary risk

to the U.S. population, infants, or

children, under reasonably forseeable

circumstances. Further, EPA finds that

there is a reasonable certainty of no

harm from aggregate exposure to

peroxyacetic acid and thus that the

exemption for peroxyacetic acid is safe.

The Agency’s human risk assessment

findings are summarized below.

1. Acute dietary risk assessment.

Acute dietary risk assessments are

performed for a food-use pesticide if a

toxicological study has indicated the

possibility of an effect of concern

occurring as a result of a 1-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. This is due to the lack of

any residues of toxicological concern

because of the rapid decomposition of

peroxyacetic acid into acetic acid,

oxygen, and water. Use of peroxyacetic

acid for indoor food equipment

sanitization uses is not expected to

result in the transfer of any residues to

potential drinking water sources.

2. Chronic dietary risk assessment.

Residues of 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 because of the rapid

decomposition of peroxyacetic acid into

acetic acid, oxygen, and water. Use of

peroxyacetic acid for indoor food

equipment sanitization uses is not

expected to result in the transfer of any

residues to potential drinking water

sources.

3. Aggregate cancer risk for U.S.

population. 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

when used as a sanitizer.

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

risk for the U.S. population from

aggregate exposure to peroxyacetic acid

is negligible under the proposed food

contact use concentrations.

4. Aggregate risks and determination

of safety for infants and children. In

assessing the potential for additional

sensitivity of infants and children to

residues of peroxyacetic acid, EPA

considered data from developmental

and reproductive toxicity studies

available from the scientific literature

and summarized by the Office of Water.

The developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

maternal pesticide exposure during

gestation. Reproduction studies provide

information relating to effects from

exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

FFDCA section 408 provides that EPA

shall apply an additional tenfold margin

of safety for infants and children in the

case of threshold effects to account for

prenatal and postnatal toxicity and the

completeness of the 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 no

observed adverse effect level (NOAEL)

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

NOAEL 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.

i. 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

milligrams/kilograms).

ii. Peroxyacetic acid is a highly

reactive and short lived molecule

because of the inherent instability of the

peroxide bond (ie., the O-O bond).

Agitation or contact with rough

surfaces, sunlight, organics, and metals

accelerates 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

75172 Federal Register / Vol. 65, No. 232 / Friday, December 1, 2000 / Rules and Regulations

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.

iii. 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 (ie., 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.

VIII. Other Considerations

A. Endocrine Disruptors

The Food Quality Protection Act

(FQPA; 1996) requires that EPA develop

a screening program to determine

whether certain substances (including

all pesticides and inerts) ‘‘may have an

effect in humans that is similar to an

effect produced by a naturally occurring

estrogen, or such other endocrine

effect....’’ EPA has been working with

interested stakeholders, including other

government agencies, public interest

groups, and industry and research

scientists to develop a screening and

testing program as well as a priority

setting scheme to implement this

program. The Agency’s proposed

Endocrine Disrupter Screening Program

was published in the Federal Register

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

the Agency proceeds with

implementation of this program, further

testing of peroxyacetic acid for

endocrine effects may be required. The

currently available animal data suggest

no significant endocrine effects from

exposure to hydrogen peroxide.

B. Analytical Method(s)

Because an exemption from the

requirement of a tolerance without

numerical limitation on residue levels is

being granted for peroxyacetic acid, an

enforcement analytical method is not

needed. However, an analytical method

(designated QATM 202 by Ecolab, Inc.,

a redox titration procedure) is available

in cases of gross misuse. The analytical

method is being made available to

anyone interested in pesticide

enforcement when requested, from

Norm Cook, Antimicrobials Division

(7510C), Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Avenue, N.W.,

Washington, DC 20460. Office location

and telephone number: 1921 Jefferson

Davis Highway, 3rd Floor, Arlington,

VA 22202, 703 308–8253.

C. Existing Tolerances

In 40 CFR Part 180.1196, 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, vegetables, tree nuts,

cereal grains, herbs, and spices.

D. International Tolerances

There are no Codex Alimentarius

(Codex) Commission Maximum Residue

Levels for peroxyacetic acid.

IX. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as

amended by the FQPA, any person may

file an objection to any aspect of this

regulation and may also request a

hearing on those objections. The EPA

procedural regulations which govern the

submission of objections and requests

for hearings appear in 40 CFR part 178.

Although the procedures in those

regulations require some modification to

reflect the amendments made to the

FFDCA by the FQPA of 1996, EPA will

continue to use those procedures, with

appropriate adjustments, until the

necessary modifications can be made.

The new section 408(g) provides

essentially the same process for persons

to ‘‘object’’ to a regulation for an

exemption from the requirement of a

tolerance issued by EPA under new

section 408(d), as was provided in the

old FFDCA sections 408 and 409.

However, the period for filing objections

is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an

Objection or Request a Hearing?

You must file your objection or

request a hearing on this regulation in

accordance with the instructions

provided in this unit and in 40 CFR part

178. To ensure proper receipt by EPA,

you must identify docket control

number OPP–301068 in the subject line

on the first page of your submission. All

requests must be in writing, and must be

mailed or delivered to the Hearing Clerk

on or before January 30, 2001.

1. Filing the request. Your objection

must specify the specific provisions in

the regulation that you object to, and the

grounds for the objections (40 CFR

178.25). If a hearing is requested, the

objections must include a statement of

the factual issues(s) on which a hearing

is requested, the requestor’s contentions

on such issues, and a summary of any

evidence relied upon by the objector (40

CFR 178.27). Information submitted in

connection with an objection or hearing

request may be claimed confidential by

marking any part or all of that

information as CBI. Information so

marked will not be disclosed except in

accordance with procedures set forth in

40 CFR part 2. A copy of the

information that does not contain CBI

must be submitted for inclusion in the

public record. Information not marked

confidential may be disclosed publicly

by EPA without prior notice.

Mail your written request to: Office of

the Hearing Clerk (1900), Environmental

Protection Agency, 1200 Pennsylvania

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

may also deliver your request to the

Office of the Hearing Clerk in Rm. C400,

Waterside Mall, 401 M St., SW.,

Washington, DC 20460. The Office of

the Hearing Clerk is open from 8 a.m.

to 4 p.m., Monday through Friday,

excluding legal holidays. The telephone

number for the Office of the Hearing

Clerk is (202) 260–4865.

2. Tolerance fee payment. If you file

an objection or request a hearing, you

must also pay the fee prescribed by 40

CFR 180.33(i) or request a waiver of that

fee pursuant to 40 CFR 180.33(m). You

must mail the fee to: EPA Headquarters

Accounting Operations Branch, Office

of Pesticide Programs, P.O. Box

360277M, Pittsburgh, PA 15251. Please

identify the fee submission by labeling

it ‘‘Tolerance Petition Fees.’’

EPA is authorized to waive any fee

requirement ‘‘when in the judgement of

the Administrator such a waiver or

refund is equitable and not contrary to

the purpose of this subsection.’’ For

additional information regarding the

waiver of these fees, you may contact

James Tompkins by phone at (703) 305–

5697, by e-mail at

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

request for information to Mr. Tompkins

at Registration Division (7505C), Office

of Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

If you would like to request a waiver

of the tolerance objection fees, you must

mail your request for such a waiver to:

James Hollins, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

3. Copies for the Docket. In addition

to filing an objection or hearing request

with the Hearing Clerk as described in

Unit VIII.A., you should also send a

copy of your request to the PIRIB for its

Federal Register / Vol. 65, No. 232 / Friday, December 1, 2000 / Rules and Regulations 75173

inclusion in the official record that is

described in Unit I.B.2. Mail your

copies, identified by docket control

number OPP–301068, to: Public

Information and Records Integrity

Branch, Information Resources and

Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460. In

person or by courier, bring a copy to the

location of the PIRIB described in Unit

I.B.2. You may also send an electronic

copy of your request via e-mail to: oppdocket@epa.gov. Please use an ASCII

file format and avoid the use of special

characters and any form of encryption.

Copies of electronic objections and

hearing requests will also be accepted

on disks in WordPerfect 6.1/8.0 file

format or ASCII file format. Do not

include any CBI in your electronic copy.

You may also submit an electronic copy

of your request at many Federal

Depository Libraries.

B. When Will the Agency Grant a

Request for a Hearing?

A request for a hearing will be granted

if the Administrator determines that the

material submitted shows the following:

There is a genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

X. Regulatory Assessment

Requirements

This final rule establishes an

exemption from the tolerance

requirement under FFDCA section

408(d) in response to a petition

submitted to the Agency. The Office of

Management and Budget (OMB) has

exempted these types of actions from

review under Executive Order 12866,

entitled Regulatory Planning and

Review (58 FR 51735, October 4, 1993).

This final rule does not contain any

information collections subject to OMB

approval under the Paperwork

Reduction Act (PRA), 44 U.S.C. 3501 et

seq., or impose any enforceable duty or

contain any unfunded mandate as

described under Title II of the Unfunded

Mandates Reform Act of 1995 (UMRA)

(Public Law 104–4). Nor does it require

any prior consultation as specified by

Executive Order 13084, entitled

Consultation and Coordination with

Indian Tribal Governments (63 FR

27655, May 19, 1998); special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994); or require OMB review or any

Agency action under Executive Order

13045, entitled Protection of Children

from Environmental Health Risks and

Safety Risks (62 FR 19885, April 23,

1997). This action does not involve any

technical standards that would require

Agency consideration of voluntary

consensus standards pursuant to section

12(d) of the National Technology

Transfer and Advancement Act of 1995

(NTTAA), Public Law 104–113, section

12(d) (15 U.S.C. 272 note). Since

tolerances and exemptions that are

established on the basis of a petition

under FFDCA section 408(d), such as

the exemption in this final rule, do not

require the issuance of a proposed rule,

the requirements of the Regulatory

Flexibility Act (RFA) (5 U.S.C. 601 et

seq.) do not apply. In addition, the

Agency has determined that this action

will not have a substantial direct effect

on States, on the relationship between

the national government and the States,

or on the distribution of power and

responsibilities among the various

levels of government, as specified in

Executive Order 13132, entitled

Federalism (64 FR 43255, August 10,

1999). Executive Order 13132 requires

EPA to develop an accountable process

to ensure ‘‘meaningful and timely input

by State and local officials in the

development of regulatory policies that

have federalism implications.’’ ‘‘Policies

that have federalism implications’’ is

defined in the Executive Order to

include regulations that have

‘‘substantial direct effects on the States,

on the relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government.’’ This final rule

directly regulates growers, food

processors, food handlers and food

retailers, not States. This action does not

alter the relationships or distribution of

power and responsibilities established

by Congress in the preemption

provisions of FFDCA section 408(n)(4).

XI. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit a

report containing this rule and other

required information to the U.S. Senate,

the U.S. House of Representatives, and

the Comptroller General of the United

States prior to publication of this final

rule in the Federal Register. This final

rule is not a ‘‘major rule ’’ as defined by

5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: November 9, 2000.

Frank Sanders,

Director, Antimicrobial Division, Office of

Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 321(q), (346a) and

371.

2. Section 180.1196 is revised to read

as follows:

§ 180.1196 Peroxyacetic acid; exemption

from the requirement of a tolerance.

(a) An exemption from the

requirement of a tolerance is established

for residues of peroxyacetic acid in or

on raw agricultural commodities, in

processed commodities, when such

residues result from the use of

peroxyacetic acid as an antimicrobial

treatment in solutions containing a

diluted end use concentration of

peroxyacetic acid up to 100 ppm per

application on fruits, vegetables, tree

nuts, cereal grains, herbs, and spices.

(b) An exemption from the

requirement of a tolerance is established

for residues of peroxyacetic acid, in or

on all raw and processed food

commodities when used in sanitizing

solutions containing a diluted end-use

concentration of peroxyacetic acid up to

500 ppm, and applied to tableware,

utensils, dishes, pipelines, tanks, vats,

fillers, evaporators, pasteurizers, aseptic

equipment, milking equipment, and

other food processing equipment in food

handling establishments including, but

not limited to dairies, dairy barns,

restaurants, food service operations,

breweries, wineries, and beverage and

food processing plants.

[FR Doc. 00–30679 Filed 11–30–00; 8:45 am]

BILLING CODE 6560–50–S