Federal Register / Vol. 62, No. 148 / Friday, August 1, 1997 / Rules and Regulations 41283

PART 81—[AMENDED]

4. The authority citation for part 81

continues to read as follows:

Authority: 42 U.S.C. 7407, 7501–7515,

7601.

Subpart C—Section 107 Attainment

Status Designations

5. Section 81.346 is amended by

revising the table ‘‘Vermont-TSP’’ to

read as follows:

§ 81.346 Vermont.

VERMONT—TSP

Designated area

Does not meet

primary standards

Does not meet

secondary

standards

Cannot be

classified

Better than

national standard

Champlain Valley Air Management Area: Essex Town (includes Essex Junction), Burlington City, South Burlington City, Winoski City ........................... X

Central Vermont Air Management area: Barre City ......................................... X

Remainder of State .......................................................................................... X

* * * * *

[FR Doc. 97–19644 Filed 7–31–97; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300524; FRL–5734–7]

RIN 2070–AB78

Copper Octanoate; Tolerance

Exemption

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes an

exemption from the requirement of a

tolerance for the fungicide copper

octanoate (CAS Reg. No. 20543–04–8,

PC Code 23306) when used in

accordance with good agricultural

practice as an active ingredient in

pesticide formulations applied to

growing crops. The petitioner, W.

Neudorff GmbH KG requested this

tolerance exemption under the Federal

Food, Drug and Cosmetic Act (FFDCA),

as amended by the Food Quality

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

in pesticide petition 6F4734.

DATES: This regulation is effective

August 1, 1997. Objections and requests

for hearings must be received by EPA on

or before September 30, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300524],

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–

300524], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7506C), 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. 1132, 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:

opp–docket@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 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–

300524]. 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: Cynthia Giles–Parker, Registration

Division 7505C, Office of Pesticide

Programs, Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460. Office location, telephone

number, and e–mail address: Crystal

Mall #2, 1921 Jefferson Davis Hwy.,

Arlington, VA, (703) 308–305–7740, e–

mail: giles–parker.

cynthia@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of January 15, 1997 (62

FR 2154)(FRL–5580–4), EPA, issued a

notice pursuant to section 408(d) of the

Federal Food, Drug, and Cosmetic Act

(FFDCA), 21 U.S.C. 346(a)(d)

announcing the filing of a pesticide

petition (PP) 6F4734 proposing to

amend the 40 CFR part 180 by

establishing an exemption from the

requirement of a tolerance for copper

octanoate in or on all raw agricultural

commodities when applied to growing

crops. This notice included a summary

of the petition prepared by W. Neudorff

GmbHKG (‘‘Neudorff’’), the registrant.

There were no comments received in

response to the notice of filing.

The petition requested that 40 CFR

180.1001(b)(1) be amended by adding

copper octanoate to the list of copper

compounds which are exempt from the

requirement of a tolerance.

I. 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 Copper Octanoate and to

make a determination, consistent with

section 408(b)(2), for an exemption from

tolerance requirements for Copper

Octanoate. EPA’s assessment of the data

associated with establishing the

tolerance exemption follows.

A. Product and Residue Chemistry

1. Product chemistry. Copper

octanoate, is a copper salt of a fatty acid.

Copper octanoate is biodegraded first by

water hydrolysis into the copper ion

and fatty acid components, and then the

fatty acids are further degraded by two

carbon units at a time until they

eventually degrade to water and CO2.

2. Magnitude of the residue

anticipated at the time of harvest and

method used to determine the residue.

No residues are expected at the time of

harvest on crops treated with copper
41284 Federal Register / Vol. 62, No. 148 / Friday, August 1, 1997 / Rules and Regulations

octanoate, because rainwater readily

washes copper octanoate off plants, and

this chemical is biodegraded by water

hydrolysis into its copper ion and fatty

acid components, and then the fatty

acids are further degraded by two

carbon units at a time until they

eventually degrade to water and CO2. In

addition, the physio–chemical

properties of soils naturally modify

copper ion availability, and when soils

are adjusted/limed to the pH required

for normal crop production, the effect is

to reduce copper availability to the crop.

Furthermore, toxic copper levels in

plants induce an imbalance with iron

which causes plant dwarfing, stunted

roots and decreased growth and yields,

which effects appear before significant

copper buildup occurs, and

consequently acts as a warning which

prevents excess application of copper

compounds to food/feed crops. Last,

even if residues were to remain on

plants, the copper ion is a trace element,

or micronutrient, essential for the

growth and well being of higher plants

and animals, including man. Therefore,

the amount of this chemical proposed

for application to plants is highly

unlikely to cause harm to plants or

animals or to leave excess residues on

the plants.

3. Analytical method for detecting

and measuring the levels of the

pesticide residue are not needed. The

Agency proposes to establish

exemptions from the requirement of a

tolerance without any numerical

limitation; therefore, the Agency has

concluded that analytical methods are

not required for enforcement purposes

for copper octanoate.

B. 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. The nature of the

toxic effects caused by Copper

Octanoate are discussed below.

1. Acute toxicity. Results of studies

conducted on a concentrate product

containing copper octanoate and for

which Neudorff has applied for

registration indicate that this chemical

has low acute toxicities. The following

outlines the results of the acute toxicity

studies:

a. An oral LD50 rat study. Male and

female rats were orally administered

single doses of undiluted test material at

a dose level of 2,000 milligrams (mg)/

kilogram(kg) mg/kg. The estimated acute

oral LD50 for copper octanoate 10%

copper fatty acids was > 2,000 mg/kg for

the sexes combined.

b. A dermal LD50 rat study. Male and

female rats received a dermal

application of undiluted test material at

a mg/kg (limit dose) for 24 hours. The

acute dermal LD50 for Copper octanoate

(10% copper fatty acid) in male and

female rats was > 2,000 mg/kg.

c. Inhalation LC50 rat study. Groups of

rats were exposed to an aerosol

concentration of 0.38 mg/L NEU 1140 F

for 4 hours. There were no mortalities

and clinical signs observed. The acute

inhalation LC50 was > 0.38 mg/L (the

highest achievable concentration) in

both sexes of rats. Since no mortality

and clinical signs occured at the highest

achievable concentration of 0.38 mg/L,

NEU 1140 F was classified as Toxicity

Category III for inhalation.

d. Primary rabbit eye irritation study.

Approximately 0.1 ml of test material

was instilled into the conjunctival sac of

one eye of three male rabbits. The other

eye served as an untreated control.

Application of NEU 1140 F caused

irritation of conjunctivae in all rabbits

which was reversible within 48 hours.

The study demonstrated that NEU 1140

F produces transient ocular irritation in

rabbits.

e. Primary rabbit skin irritation study.

Test material, 0.5 g, moistened with 0.5

ml of 0.5% distilled water was applied

to a clipped skin area of three rabbits for

4 hours. The study demonstrated that

copper ocatnoate is non–irritating to the

rabbit skin.

f. Dermal sensitization guinea pig

study. In a Maximization Test, 20 guinea

pigs received 3 intradermal injections of

0.5% NEU 1140 F in distilled water and

an epidermal application of undiluted

test material during the induction

phase. During the challenge phase, a

topical appication of 50% test substance

concentraton in distilled water was

administered to animals. The study

showed that NEU1140 is a non–

sensitizer of skin in female guinea pigs.

2. Genotoxicity, reproductive and

developmental toxicity, subchronic

toxicity, and chronic toxicity. There is

adequate information available to

characterize the toxicity of the copper

ion. Copper is ubiquitous in nature and

is a necessary nutritional element for

both animals and plants. It is 1 of 26

elements found essential to life. The

copper ion is present in the adult

human body at levels of 80–150 mg.

Oral ingestion of excessive amounts of

the copper ion from pesticidal uses is

unlikely; copper compounds are

irritating to the gastric mucosa and

emesis usually occurs promptly, thereby

reducing the amount of copper ion

available for absorption into the human

body. Only a small percentage of

ingested copper is absorbed, and most of

the absorbed copper is excreted. In view

of the facts that the copper ion occurs

naturally in most foods and the

metabolism of copper is well

understood, there is no reason to expect

that long–term exposure to the copper

ion in the diet is likely to pose the risks

of chronic or sub–chronic adverse

effects. It is unlikely that the toxicity

profile for copper octanoate would

differ significantly from the numerous

other copper compounds which are

already exempted from the requirement

of a tolerance.

C. Aggregate Exposure

As part of the hazard assessment

process, the Agency reviews the

available toxicological database to

determine the endpoints of concern for

acute and chronic dietary exposure; and

short, intermediate and chronic term

occupational and residential exposure.

In the case of copper octanoate the

Agency only reviewed acute toxicity

data on the end–use product

formulations, since information

currently available to the Agency

indicates that there is no significant

toxicity from exposure to copper

octanoate that lasts from 1 day to several

months. The Agency has exempted from

the requirement of a tolerance other

compounds similar to copper octanoate,

such as the, copper salts of fatty acids

that include: copper oleate, copper

lineolate and copper acetate which are

listed in 40 CFR 1011(b)(1). Therefore,

no risk assessments are required for any

exposure scenarios.

After taking into account the factors

set forth in section 408(b)(2)(D), EPA

concludes that copper does not present

a dietary risk under reasonably

forseeable circumstances. Accordingly,

EPA concludes that there is a reasonable

certainty that no harm will result to

consumers, including infants and

children, from aggregate exposure to

copper. Because copper has no

significant toxicity EPA has not assessed

its risk using a margin of safety

approach and, therefore, the

requirement pertaining to an additional

safety factor for infants and children is

not applicable to EPA’s safety

determination for this exemption.

D. Existing Tolerances

1. Existing tolerances or tolerance

exemptions. EPA has not established a

tolerance or an exemption from the

requirement for a tolerance for this

chemical. However, EPA has

promulgated a tolerance exemption for

a group of similar copper–based

chemicals, i.e., Bordeaux mixture,

copper acetate, basic copper carbonate

(malachite), copper hydroxide, copper–
Federal Register / Vol. 62, No. 148 / Friday, August 1, 1997 / Rules and Regulations 41285

lime mixtures, copper linoleate, copper

oleate, copper oxychloride, copper

sulfate basic, copper sulfate

monohydrate, copper sulfate

pentahydrate, copper–zinc chromate,

cupric oxide, and cuprous oxide (two of

these chemicals are copper salts of fatty

acids), when they are applied to

growing crops in accordance with good

agricultural practice. See 40 CFR

180.1001(b)(1). In addition, EPA has

promulgated a tolerance exemption for

copper residues in meat, milk, poultry,

eggs, fish, and irrigated crops when they

result from the use of certain copper

compounds, i.e., copper sulfate, basic

copper carbonate, copper

triethanolamine, copper

monoethanolamine, and cuprous oxide,

at certain sites. See 40 FR 180.1021. The

common basis for EPA’s tolerance

exemptions for the compounds in these

two classes of copper compounds

appears to be the fact that the copper

ion is the entity responsible for their

fungicidal action, and there is adequate

data on the copper ion upon which EPA

can make judgments about its potential

for causing unreasonable adverse effects

to humans or the environment.

2. International tolerances. No

maximum residue level has been

established for this substance by the

Codex Alimentarius Commission.

II. Conclusion

Therefore, an exemption from

requirement of a tolerance is established

for copper octanoate in pesticide

formulations applied to growing crops.

III. 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 (1)(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 September 30,

1997, file written objections to any

aspect of this regulation and may also

request a hearing on those objections.

Objections and hearing requests must be

filed with the Hearing Clerk, at the

address given above (40 CFR 178.20). A

copy of the objections and/or hearing

requests filed with the Hearing Clerk

should be submitted to the OPP docket

for this rulemaking. The objections

submitted must specify the provisions

of the regulation deemed objectionable

and the grounds for the objections (40

CFR 178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issues on which

a hearing is requested, the requestor’s

contentions on such issues, and a

summary of any evidence relied upon

by the requestor (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

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

Confidential Business Information (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. 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

IV. Public Docket

EPA has established a record for this

rulemaking under docket control

number [OPP–300524] (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 1132 of the Public Information

and Records Integrity Branch,

Information Resources and Services

Division (7506C), Office of Pesticide

Programs, Environmental Protection

Agency, Crystal Mall #2, 1921 Jefferson

Davis Highway, Arlington, VA.

Electronic comments may be sent

directly to EPA at:

opp–docket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

V. 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
41286 Federal Register / Vol. 62, No. 148 / Friday, August 1, 1997 / Rules and Regulations

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.

VI. 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: July 24, 1997.

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.

§ 180.1001 [Amended]

2. In § 180.1001, Exemptions from the

requirement of a tolerance, by adding

and alphabetically inserting copper

octanoate in paragraph (b)(1).

[FR Doc. 97–20361 Filed 7-31-97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300520; FRL–5732–5]

RIN 2070–AB78

Fludioxonil; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for residues of

fludioxonil in or on potatoes . This

action is in response to EPA’s granting

of an emergency exemption under

section 18 of the Federal Insecticide,

Fungicide, and Rodenticide Act

authorizing use of the pesticide on

potatoes. This regulation establishes a

maximum permissible level for residues

of fludioxonil in this food commodity

pursuant to section 408(l)(6) of the

Federal Food, Drug, and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996. The tolerance

will expire and is revoked on August 1,

1998.

DATES: This regulation is effective

August 1, 1997. Objections and requests

for hearings must be received by EPA on

or before September 30, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300520],

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–

300520], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7506C), 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. 1132, 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 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–

300520]. 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: Andrew Ertman, Registration

Division 7505C, Office of Pesticide

Programs, Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460. Office location, telephone

number, and e-mail address: Crystal

Mall #2, 1921 Jefferson Davis Hwy.,

Arlington, VA, (703) 308-9367, e-mail:

ertman.andrew@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on

its own initiative, pursuant to section

408(e) and (l)(6) of the Federal Food,

Drug, and Cosmetic Act (FFDCA), 21

U.S.C. 346a(e) and (l)(6), is establishing

a tolerance for residues of the fungicide

fludioxonil, in or on potatoes at 0.02

part per million (ppm). This tolerance

will expire and is revoked on August 1,

1998. EPA will publish a document in

the Federal Register to remove the

revoked tolerance from the Code of

Federal Regulations.

I. Background and Statutory Authority

The Food Quality Protection Act of

1996 (FQPA) (Pub. L. 104–170) was

signed into law August 3, 1996. FQPA

amends both the Federal Food, Drug,

and Cosmetic Act (FFDCA), 21 U.S.C.

301 et seq., and the Federal Insecticide,

Fungicide, and Rodenticide Act

(FIFRA), 7 U.S.C. 136 et seq . The FQPA

amendments went into effect

immediately. Among other things,

FQPA amends FFDCA to bring all EPA

pesticide tolerance-setting activities

under a new section 408 with a new

safety standard and new procedures.

These activities are described below and

discussed in greater detail in the final

rule establishing the time-limited

tolerance associated with the emergency

exemption for use of propiconazole on

sorghum (61 FR 58135, November 13,

1996)(FRL-5572-9).

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

FFDCA allows EPA to establish 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