33478 Federal Register / Vol. 66, No. 121 / Friday, June 22, 2001 / Rules and Regulations

failure to use VCS. It would thus be

inconsistent with applicable law for

EPA, when it reviews a SIP submission,

to use VCS in place of a SIP submission

that otherwise satisfies the provisions of

the Clean Air Act. Thus, the

requirements of section 12(d) of the

National Technology Transfer and

Advancement Act of 1995 (15 U.S.C.

272 note) do not apply. As required by

section 3 of Executive Order 12988 (61

FR 4729, February 7, 1996), in issuing

this rule, EPA has taken the necessary

steps to eliminate drafting errors and

ambiguity, minimize potential litigation,

and provide a clear legal standard for

affected conduct. EPA has complied

with Executive Order 12630 (53 FR

8859, March 15, 1988) by examining the

takings implications of the rule in

accordance with the ‘‘Attorney

General’s Supplemental Guidelines for

the Evaluation of Risk and Avoidance of

Unanticipated Takings’’ issued under

the executive order. This rule does not

impose an information collection

burden under the provisions of the

Paperwork Reduction Act of 1995 (44

U.S.C. 3501 et seq.).

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 the rule in

the Federal Register. A major rule

cannot take effect until 60 days after it

is published in the Federal Register.

This action is not a ‘‘major rule’’ as

defined by 5 U.S.C. 804(2). This rule

will be effective August 6, 2001 unless

EPA receives adverse written comments

by July 23, 2001.

Under section 307(b)(1) of the Clean

Air Act, petitions for judicial review of

this action must be filed in the United

States Court of Appeals for the

appropriate circuit by August 21, 2001.

Filing a petition for reconsideration by

the Administrator of this final rule does

not affect the finality of this rule for the

purposes of judicial review nor does it

extend the time within which a petition

for judicial review may be filed, and

shall not postpone the effectiveness of

such rule or action. This action may not

be challenged later in proceedings to

enforce its requirements. (See section

307(b)(2).)

List of Subjects in 40 CFR Part 52

Environmental protection, Air

pollution control, Hydrocarbons, Ozone,

Nitrogen oxides, Transportation

conformity.

Dated: June 14, 2001.

David A. Ullrich,

Acting Regional Administrator, Region 5.

Part 52, chapter I, title 40 of the Code

of Federal Regulations is amended as

follows:

PART 52—[AMENDED]

1. The authority citation for part 52

continues to read as follows:

Authority: 42 U.S.C. 7401 et seq.

Subpart KK—Ohio

2. Section 52.1885 is amended by

adding paragraph (a)(15) to read as

follows:

§ 52.1885 Control strategy: ozone.

(a) * * *

(15) Approval—On May 31, 2001,

Ohio submitted a revision to the ozone

maintenance plan for the Cleveland/

Akron/Lorain area. The revision

consists of allocating a portion of the

Cleveland/Akron/Lorain area’s NOX

safety margin to the transportation

conformity mobile source emissions

budget. The mobile source emissions

budgets for transportation conformity

purposes for the Cleveland/Akron/

Lorain area are now: 92.7 tons per day

of volatile organic compound emissions

for the year 2006 and 104.4 tons per day

of oxides of nitrogen emissions for the

year 2006. This approval only changes

the VOC transportation conformity

emission budget for Cleveland/Akron/

Lorain.

* * * * *

[FR Doc. 01–15749 Filed 6–21–01; 8:45 am]

BILLING CODE 6560–50–U

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301120; FRL–6778–7]

RIN 2070–AB78

Cyprodinil; Time-Limited Pesticide

Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for residues of

cyprodinil in or on strawberry, dry bulb

onion, and green onion. IR-4 requested

these tolerances under the Federal Food,

Drug, and Cosmetic Act, as amended by

the Food Quality Protection Act of 1996.

These tolerances will expire on

December 31, 2003.

DATES: This regulation is effective June

22, 2001. Objections and requests for

hearings, identified by docket control

number OPP–301120, must be received

by EPA on or before August 21, 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 VI. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301120 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Hoyt Jamerson, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 308–9368; and e-mail

address: jamerson.hoyt@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.

Federal Register / Vol. 66, No. 121 / Friday, June 22, 2001 / Rules and Regulations 33479

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/. To access the

OPPTS Harmonized Guidelines

referenced in this document, go directly

to the guidelines at http://www.epa.gov/

opptsfrs/home/guidelin.htm.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–301120. 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 June 21,

2000 (65 FR 38535) (FRL–6558–9), 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 of 1996 (FQPA) (Public Law 104–

170) announcing the filing of a pesticide

petition (PP) 8E5012 for tolerances by,

IR-4, North Brunswick, New Jersey

08902–3390. This notice included a

summary of the petition prepared by

Novartis Crop Protection, Inc., the

registrant. There were no comments

received in response to the notice of

filing.

The petition requested that 40 CFR

180.532 be amended by establishing

tolerances for residues of the fungicide

cyprodinil, 4-cyclopropyl-6-methyl-Nphenyl-2-pyrimidinamine, in or on

strawberry at 5.0 parts per million

(ppm) and the bulb vegetable crop group

at 5 ppm. The petition was subsequently

amended by IR-4 to propose timelimited tolerances for residues of

cyprodinil in or on strawberry at 5.0

ppm, dry bulb onion at 0.60 ppm, and

green onion at 4.0 ppm. These

tolerances will expire on December 31,

2003.

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

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. For

further discussion of the regulatory

requirements of section 408 and a

complete description of the risk

assessment process, see the final rule on

Bifenthrin Pesticide Tolerances (62 FR

62961, November 26, 1997) (FRL–5754–

7).

III. 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 and to make a determination

on aggregate exposure, consistent with

section 408(b)(2), for tolerances for

residues of cyprodinil on strawberry at

5.0 ppm, dry bulb onion at 0.6 ppm and

green onion at 4.0 ppm. EPA’s

assessment of exposures and risks

associated with establishing the

tolerances 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 cyprodinil are

discussed in the following Table 1 as

well as the no observed adverse effect

level (NOAEL) and the lowest observed

adverse effect level (LOAEL) from the

toxicity studies reviewed.

TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY

Guideline No. Study Type Results

28–Day oral toxicity (gavage) (rat) NOAEL = 10 mg/kg/day

LOAEL = 100 mg/kg/day based on based on increased liver weights and

abnormalities in liver morphology

870.3150 90–Day oral toxicity (dog) NOAEL = 210 mg/kg/day (males) and 232 mg/kg/day (females)

LOAEL = 560 mg/kg/day (males) and 581 mg/kg/day (females) based on

lower body weight gains and decreased food consumption in both

sexes

870.3200 28–Day dermal toxicity (rat) NOAEL = 5 mg/kg/day (females) and 125 mg/kg/day (males)

33480 Federal Register / Vol. 66, No. 121 / Friday, June 22, 2001 / Rules and Regulations

TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY—Continued

Guideline No. Study Type Results

LOAEL = 25 mg/kg/day for females and 1,000 mg/kg/day for males based

on alterations in clinical signs (piloerection)

870.3100 90–Day oral toxicity (rat) NOAEL = 3.14 mg/kg/day

LOAEL = 19 mg/kg/day based on increased chronic tubular kidney lesions

in males

870.3100 90–Day oral toxicity (mouse) NOAEL = 73.3/103 mg/kg/day, males/females

LOAEL = 257/349 mg/kg/day, males/females based on histopathological

changes in the liver

870.3700a Prenatal developmental (rat) Maternal NOAEL = 200 mg/kg/day

LOAEL = 1,000 mg/kg/day based on lower body weight/body weight gain

and reduced food consumption

Developmental NOAEL = 200 mg/kg/day

LOAEL = 1,000 mg/kg/day based on lower mean fetal weights and an increased incidence of delayed ossification

870.3700b Prenatal developmental (rabbit) Maternal NOAEL = 150 mg/kg/day

LOAEL = 400 mg/kg/day based on decreased body weight gain

Developmental NOAEL = 150 mg/kg/day LOAEL = 400 mg/kg/day based

on a slight increase of litters showing extra (13th) ribs.

870.3800 Reproduction and fertility effects (rat) Parental/Systemic NOAEL = 81 mg/kg/day

LOAEL = 326 mg/kg/day based on based on lower body weights in F0 females during the pre-mating period

Reproductive NOAEL = 81 mg/kg/day

LOAEL = 326 mg/kg/day based on decreased pup weights (F1 and F2.

870.4300 Chronic toxicity/carcinogenicity (rat) NOAEL = 2.7 mg/kg/day

LOAEL = 35.6 mg/kg/day based on degenerative liver lesions (spongiosis

hepatis) in males. There was no evidence of carcinogenicity in rat fed

diets containing 0, 0.177, 2.7, 35.6 or 73.6 mg/kg/day (males); 0, 0.204,

3.22, 41.2 or 87.1 mg/kg/day (females) for 24-months. There was an increase in mammary fibroadenomas from controls to high dose, which

was considered to be non-treatment related.

870.4100b Chronic toxicity (dog) NOAEL = 65.63 mg/kg/day (males) and 67.99 mg/kg/day (females)

LOAEL = 446.37 mg/kg/day (females) and 449.25 mg/kg/day (males)

based on lower body weight gains and decreased food consumption

and food efficacy.

870.4200 Carcinogenicity in mice NOAEL = 16.1 mg/kg/day (males).

LOAEL = 212.4 mg/kg/day based on a dose-related increase in the incidence of focal and mutltifocal hyperplasia of the exocrine pancreas in

males. There was no evidence of carcinogenicity.

870.5100 Gene mutation/bacteria Negative in bacterial cells (S. typhimurium and (E. coli) and mammalian

cells (V79/HGPRT assay)

870.5300 Gene mutation/Mammalian cell Negative with and without activation

870.5375 Chromosome aberration (Chinese hamster

ovary)

Negative; up to 25 micrograms/milliter (μg/ml) (-S9); up to 50 μg/ml (+S9)

870.5550 In vitro unscheduled DNA synthesis assay -

primary rat hepatocytes

Negative; 0.74 to 80 μg/ml; cytotoxicity was seen at concentrations of 80

μg/ml

Federal Register / Vol. 66, No. 121 / Friday, June 22, 2001 / Rules and Regulations 33481

TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY—Continued

Guideline No. Study Type Results

870.5395 In vivo mouse micronucleus assay - bone

marrow

Negative; single dose (gavage) 1,250 or 5,000 mg/kg

870.7485 Metabolism and pharmacokinetics In a metabolism study in rats, single oral doses (0.5 or 100 mg/kg bw) of

phenyl or pyrimidyl-radiolabelled cyprodinil were administered, with one

low-dose group receiving unlabeled cyprodinil for 2 weeks prior to treatment with radiolabelled compound. Excretion was rapid and almost

complete, with urine as the principle route of excretion. Tissue residues

declined rapidly, with the highest concentrations (≥ 1.8 ppm) found in

kidneys, liver, lungs, spleen, thyroid, whole blood, and carcass. Unchanged parent compound was detected in feces extract only. Excretion, distribution and metabolite profiles were essentially independent of

dose level, pretreatment, and type of label, although there were some

sex- dependent qualitative differences in two urinary metabolite fractions. Eleven metabolites were isolated from urine, feces and bile, and

the metabolic pathways in the rat were proposed. All urinary and biliary

metabolites (with one exception) were conjugated with glucuronic acid

or sulfonated, and excreted. Cyprodinil was almost completely metabolized by hydroxylation of the phenyl ring (position 4) or pyrimidine ring

(position 5), followed by conjugation. An alternative pathway involved

oxidation of the phenyl ring followed by glucuronic acid conjugation. A

quantitative sex difference was observed with respect to sulfonation of

the major metabolite. The monosulfate metabolite was predominant in

females, whereas equal amounts of mono- and disulfate conjugates

were noted in males. Most of the significant metabolites in feces were

exocons of biliary metabolites. These were assumed to be

deconjugated in the intestines, partially reabsorbed into the general circulation, conjugated again, and eliminated renally. The major metabolic

pathways of cyprodinil were not significantly influenced by the dose,

treatment regimen, or sex of the animal.

B. Toxicological Endpoints

The dose at which no adverse effects

are observed (the NOAEL) from the

toxicology study identified as

appropriate for use in risk assessment is

used to estimate the toxicological level

of concern (LOC). However, the lowest

dose at which adverse effects of concern

are identified (the LOAEL) is sometimes

used for risk assessment if no NOAEL

was achieved in the toxicology study

selected. An uncertainty factor (UF) is

applied to reflect uncertainties inherent

in the extrapolation from laboratory

animal data to humans and in the

variations in sensitivity among members

of the human population as well as

other unknowns. An UF of 100 is

routinely used, 10X to account for

interspecies differences and 10X for

intraspecies differences.

For dietary risk assessment (other

than cancer) the Agency uses the UF to

calculate an acute or chronic reference

dose (acute RfD or chronic RfD) where

the RfD is equal to the NOAEL divided

by the appropriate UF (RfD = NOAEL/

UF). Where an additional safety factor is

retained due to concerns unique to the

FQPA, this additional factor is applied

to the RfD by dividing the RfD by such

additional factor. The acute or chronic

Population Adjusted Dose (aPAD or

cPAD) is a modification of the RfD to

accommodate this type of FQPA Safety

Factor.

For non-dietary risk assessments

(other than cancer) the UF is used to

determine the LOC. For example, when

100 is the appropriate UF (10X to

account for interspecies differences and

10X for intraspecies differences) the

LOC is 100. To estimate risk, a ratio of

the NOAEL to exposures (margin of

exposure (MOE) = NOAEL/exposure) is

calculated and compared to the LOC.

The linear default risk methodology

(Q*) is the primary method currently

used by the Agency to quantify

carcinogenic risk. The Q* approach

assumes that any amount of exposure

will lead to some degree of cancer risk.

A Q* is calculated and used to estimate

risk which represents a probability of

occurrence of additional cancer cases

(e.g., risk is expressed as 1 x 10-6 or one

in a million). Under certain specific

circumstances, MOE calculations will

be used for the carcinogenic risk

assessment. In this non-linear approach,

a ‘‘point of departure’’ is identified

below which carcinogenic effects are

not expected. The point of departure is

typically a NOAEL based on an

endpoint related to cancer effects

though it may be a different value

derived from the dose response curve.

To estimate risk, a ratio of the point of

departure to exposure (MOE cancer =

point of departure/exposures) is

calculated. A summary of the

toxicological endpoints for cyprodinil

used for human risk assessment is

shown in the following Table 2:

TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR CYPRODONIL FOR USE IN HUMAN RISK ASSESSMENT

Exposure Scenario Dose Used in Risk Assessment, UF

FQPA SF* and Endpoint for

Risk Assessment Study and Toxicological Effects

Acute dietary (all populations) Not applicable Not applicable There were no effects that could be attributed to a single exposure (dose) in oral

toxicity studies including the developmental toxicity studies in rats and rabbits.

33482 Federal Register / Vol. 66, No. 121 / Friday, June 22, 2001 / Rules and Regulations

TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR CYPRODONIL FOR USE IN HUMAN RISK

ASSESSMENT—Continued

Exposure Scenario Dose Used in Risk Assessment, UF

FQPA SF* and Endpoint for

Risk Assessment Study and Toxicological Effects

Chronic dietary (all populations)NOAEL= 2.7 mg/kg/day FQPA SF = 1 Combined/chronic toxicity - rat

UF = 100 cPAD = 0.03 ÷ 1 0.03 mg/kg/

day

LOAEL = 35.6 mg/kg/day based on increased incidence of spongiosis hepatis in

the liver

Chronic RfD = 0.03 mg/kg/

day

Short-term dermal (1–7 days) Dermal study NOAEL= 25.0

mg/kg/day

LOC for MOE = 100 (includes

the FQPA SF)

21–day dermal study - rat

LOAEL = 125 mg/kg/day based on hunched

posture

Intermediate- term dermal (1

week – several months)

Dermal study NOAEL= 25.0

mg/kg/day

LOC for MOE = 100 (includes

the FQPA SF)

21–day dermal study - rat

LOAEL = 125 mg/kg/day based on hunched

posture

Long-term dermal (several

months - lifetime)

Not applicable Not applicable Based on the current use pattern, there is no

potential for long-term dermal exposure.

Inhalation (any time period) Not applicable Not applicable The current use pattern, the low exposure

potential and the low toxicity (Toxicity Category III) do not indicate a significant potential for exposure via this route.

Cancer (oral, dermal, inhalation)‘‘Not likely’’ to be a human

carcinogen

Not applicable There is no evidence of carcinogenic potential, therefore, cancer risk assessment is

not required.

* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique to the FQPA.

C. Exposure Assessment

1. Dietary exposure from food and

feed uses. Tolerances have been

established (40 CFR 180.532(a)) for the

residues of cyprodinil, in or on food

commodities as follows: almond

nutmeats at 0.02 ppm, almond hulls at

0.05 ppm, pome fruit at 0.1 ppm, apple,

wet pomace at 0.15 ppm, grapes at 2.0

ppm, raisins at 3.0 ppm and stone fruit

at 2.0 ppm. Time-limited tolerances in

association with section 18 of FIFRA

(emergency exemptions) have been

established under 180.532(b) for

caneberries at 10 ppm and strawberries

at 5.0 ppm. Risk assessments were

conducted by EPA to assess dietary

exposures from cyprodinil in food as

follows:

i. Acute exposure. Acute dietary risk

assessments are performed for a fooduse 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. The Agency did not

conduct an acute dietary risk

assessment since no toxicological

endpoint of concern was identified

during the review of the available data.

ii. Chronic exposure. In conducting

this chronic dietary risk assessment, the

Dietary Exposure Evaluation Model

(DEEM) analysis evaluated the

individual food consumption as

reported by respondents in the USDA

(1989–1992) nationwide Continuing

Surveys of Food Intake by Individuals

(CSFII) and accumulated exposure to

the chemical for each commodity. The

following assumptions were made for

the chronic exposure assessments: A

conservative analysis was performed

using published and proposed tolerance

level residues and 100% crop treated

information for all commodities.

iii. Cancer. Cyprodinil is classified as

‘‘not likely’’ to be a human carcinogen

by all routes of exposure based on lack

of evidence of carcinogenicity in mice

and rats, therefore, a cancer risk

assessment was not performed.

2. Dietary exposure from drinking

water. Cyprodinil has a low potential for

significant movement into ground water

under most conditions. There is a

moderate risk of cyprodinil

contaminating surface water as runoff

and through erosion of soil particles to

which cyprodinil is absorbed. However,

if cyprodinil residues were to reach

surface water and/or ground water, it

may persist for a significant period of

time.

The Agency lacks sufficient

monitoring exposure data to complete a

comprehensive dietary exposure

analysis and risk assessment for

cyprodinil in drinking water. Because

the Agency does not have

comprehensive monitoring data,

drinking water concentration estimates

are made by reliance on simulation or

modeling taking into account data on

the physical characteristics of

cyprodinil.

The Agency uses the Generic

Estimated Environmental Concentration

(GENEEC) or the Pesticide Root Zone/

Exposure Analysis Modeling System

(PRZM/EXAMS) to estimate pesticide

concentrations in surface water and SCIVerDate 11<MAY>2000 15:30 Jun 21, 2001 Jkt 194001 PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 E:\FR\FM\22JNR1.SGM pfrm04 PsN: 22JNR1
Federal Register / Vol. 66, No. 121 / Friday, June 22, 2001 / Rules and Regulations 33483

GROW, which predicts pesticide

concentrations in ground water. In

general, EPA will use GENEEC (a tier 1

model) before using PRZM/EXAMS (a

tier 2 model) for a screening-level

assessment for surface water. The

GENEEC model is a subset of the PRZM/

EXAMS model that uses a specific highend runoff scenario for pesticides.

GENEEC incorporates a farm pond

scenario, while PRZM/EXAMS

incorporate an index reservoir

environment in place of the previous

pond scenario. The PRZM/EXAMS

model includes a percent crop area

factor as an adjustment to account for

the maximum percent crop coverage

within a watershed or drainage basin.

None of these models include

consideration of the impact processing

(mixing, dilution, or treatment) of raw

water for distribution as drinking water

would likely have on the removal of

pesticides from the source water. The

primary use of these models by the

Agency at this stage is to provide a

coarse screen for sorting out pesticides

for which it is highly unlikely that

drinking water concentrations would

ever exceed human health levels of

concern.

Since the models used are considered

to be screening tools in the risk

assessment process, the Agency does

not use estimated environmental

concentrations (EECs) from these

models to quantify drinking water

exposure and risk as a %RfD or %PAD.

Instead drinking water levels of

comparison (DWLOCs) are calculated

and used as a point of comparison

against the model estimates of a

pesticide’s concentration in water.

DWLOCs are theoretical upper limits on

a pesticide’s concentration in drinking

water in light of total aggregate exposure

to a pesticide in food, and from

residential uses. Since DWLOCs address

total aggregate exposure to cyprodinil

they are further discussed in the

aggregate risk sections below.

Based on the PRZM/EXAMS and SCIGROW models the estimated

environmental concentrations (EECs) of

cyprodinil in surface water and ground

water for acute exposures are estimated

to be 52.9 parts per billion (ppb) for

surface water and 0.033 ppb for ground

water. The EECs for chronic exposures

are estimated to be 51 ppb for surface

water and 0.033 ppb for ground water.

3. From non-dietary exposure. The

term ‘‘residential exposure’’ is used in

this document to refer to nonoccupational, non-dietary exposure

(e.g., for lawn and garden pest control,

indoor pest control, termiticides, and

flea and tick control on pets).

Cyprodonil is not registered for use on

any sites that would result in residential

exposure.

4. Cumulative exposure to substances

with a 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.’’

EPA does not have, at this time,

available data to determine whether

cyprodinil has a common mechanism of

toxicity with other substances or how to

include this pesticide in a cumulative

risk assessment. Unlike other pesticides

for which EPA has followed a

cumulative risk approach based on a

common mechanism of toxicity,

cyprodinil does not appear to produce

a toxic metabolite produced by other

substances. For the purposes of this

tolerance action, therefore, EPA has not

assumed that cyprodinil has a common

mechanism of toxicity with other

substances. For information regarding

EPA’s efforts to determine which

chemicals have a common mechanism

of toxicity and to evaluate the

cumulative effects of such chemicals,

see the final rule for Bifenthrin Pesticide

Tolerances (62 FR 62961, November 26,

1997).

D. Safety Factor for Infants and

Children

1. Safety factor for infants and

children—i. In general. FFDCA section

408 provides that EPA shall apply an

additional tenfold margin of safety for

infants and children in the case of

threshold effects to account for prenatal

and postnatal toxicity and the

completeness of the data base on

toxicity and exposure unless EPA

determines that a different margin of

safety will be safe for infants and

children. Margins of safety are

incorporated into EPA risk assessments

either directly through use of a margin

of exposure (MOE) analysis or through

using uncertainty (safety) factors in

calculating a dose level that poses no

appreciable risk to humans.

ii. Prenatal and postnatal sensitivity.

There is no indication of quantitative or

qualitative increased susceptibility of

rats or rabbits to in utero and/or

postnatal exposure.

2. Conclusion. EPA determined that

the 10X safety factor to protect infants

and children should be removed. The

FQPA factor is removed because: The

toxicology data base is complete for the

assessment of the effects following in

utero and/or postnatal exposure; there is

no indication of quantitative or

qualitative increased susceptibility of

rats or rabbits to in utero and/or

postnatal exposure; EPA determined

that a developmental neurotoxicity

study is not required; the dietary (food

and drinking water) exposure

assessments will not underestimate the

potential exposures for infants and

children; and there are no registered

residential uses at the current time.

E. Aggregate Risks and Determination of

Safety

To estimate total aggregate exposure

to a pesticide from food, drinking water,

and residential uses, the Agency

calculates DWLOCs which are used as a

point of comparison against the model

estimates of a pesticide’s concentration

in water (EECs). DWLOC values are not

regulatory standards for drinking water.

DWLOCs are theoretical upper limits on

a pesticide’s concentration in drinking

water in light of total aggregate exposure

to a pesticide in food and residential

uses. In calculating a DWLOC, the

Agency determines how much of the

acceptable exposure (i.e., the PAD) is

available for exposure through drinking

water (e.g., allowable chronic water

exposure (mg/kg/day) = cPAD - (average

food + residential exposure)). This

allowable exposure through drinking

water is used to calculate a DWLOC.

A DWLOC will vary depending on the

toxic endpoint, drinking water

consumption, and body weights. Default

body weights and consumption values

as used by the USEPA Office of Water

to calculate DWLOCs: 2L/70 kg (adult

male), 2L/60 kg (adult female), and 1L/

10 kg (child). Default body weights and

drinking water consumption values vary

on an individual basis. This variation

will be taken into account in more

refined screening-level and quantitative

drinking water exposure assessments.

Different populations will have different

DWLOCs. Generally, a DWLOC is

calculated for each type of risk

assessment used: acute, short-term,

intermediate-term, chronic, and cancer.

When EECs for surface water and

ground water are less than the

calculated DWLOCs, OPP concludes

with reasonable certainty that exposures

to the pesticide in drinking water (when

considered along with other sources of

exposure for which OPP has reliable

data) would not result in unacceptable

levels of aggregate human health risk at

this time. Because OPP considers the

aggregate risk resulting from multiple

exposure pathways associated with a

pesticide’s uses, levels of comparison in

drinking water may vary as those uses

change. If new uses are added in the

future, OPP will reassess the potential

33484 Federal Register / Vol. 66, No. 121 / Friday, June 22, 2001 / Rules and Regulations

impacts of residues of the pesticide in

drinking water as a part of the aggregate

risk assessment process.

1. Acute risk. Acute aggregate risk is

negligible since no acute toxicological

endpoint of concern was identified.

2. Chronic risk. Using the exposure

assumptions described in this unit for

chronic exposure, EPA has concluded

that exposure to cyprodinil from food

will utilize 7% of the cPAD for the U.S.

population, 23% of the cPAD for all

infants < 1 year old and 22% of the

cPAD for children 1–6 years old. There

are no residential uses for cyprodinil

that result in chronic residential

exposure to cyprodinil. In addition,

there is potential for chronic dietary

exposure to cyprodinil in drinking

water. After calculating DWLOCs and

comparing them to the EECs for surface

and ground water, EPA does not expect

the aggregate exposure to exceed 100%

of the cPAD, as shown in the following

Table 3:

TABLE 3.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO CYPRODINIL

Population Subgroup cPAD (mg/kg) % cPAD (Food) Surface Water

EEC (ppb)

Ground

Water EEC

(ppb)

Chronic

DWLOC

(ppb)

U.S. population 0.03 7 51 0.033 974

Infant < 1 year old 0.03 23 51 0.033 230

3. Short- and intermediate-term risk.

Short- and intermediate-term aggregate

exposure takes into account residential

exposure plus chronic exposure to food

and water (considered to be a

background exposure level).

Cyprodinil is not registered for use on

any sites that would result in residential

exposure. Therefore, the aggregate risk

is the sum of the risk from food and

water, which do not exceed the

Agency’s level of concern.

4. Aggregate cancer risk for U.S.

population. Cyprodinil is classified as

‘‘not likely to be human carcinogen,’’

therefore, EPA concludes that

cyprodinil poses no greater than a

negligible cancer risk.

5. Determination of safety. Based on

these risk assessments, EPA concludes

that there is a reasonable certainty that

no harm will result to the general

population, and to infants and children

from aggregate exposure to cyprodinil

residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Ciby Geigy Method AG-631A is

adequate for enforcement of tolerances

for residues of cyprodinil in/on

strawberry and dry bulb and green

onions. Method AG-631A is a reissue of

Method(s) AG-631/REM 141.01 which

has successfully undergone an

independent laboratory validation (ILV)

as well as an Agency petition method

validation (PMV) in conjunction with

permanent tolerance petitions for use on

stone fruits and almonds. The method

includes a GC-NPD confirmatory

method and has been radiovalidated

using samples of 14C cyprodinil-treated

tomatoes. Once minor deficiencies cited

in the PMVs have been resolved (the

petitioner was required to submit a

standard of cyprodinil and material

safety data sheet (MSDS) to the EPA

repository and to incorporate the

necessary method revisions), the

method will be forwarded to FDA for

inclusion in PAM II.

The method may be requested from:

Calvin Furlow, PIRIB, IRSD (7502C),

Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: (703)

305–5229; e-mail address:

furlow.calvin@epa.gov.

B. International Residue Limits

There are no CODEX, Canadian or

Mexican maximum residue limits for

strawberries, dry bulb onions or green

onions.

C. Conditions

The residue field trials do not support

permanent tolerances for cyprodinil

residues in or on strawberry and onions.

The residue field trials were conducted

at exaggerated application rates (2.3

times the proposed use rates). Since

EPA expects that residues from field

trials preformed at the proposed use

rates will be lower than those reported

at the 2.3 times rate, conditional

registration and time-limited tolerances

may be established using the available

data on strawberry and onions.

Based on the findings from a confined

accumulation in rotational crops study,

EPA has concluded that a field

accumulation in rotational crop study

should be conducted and residues of the

cyprodinil metabolites (CGA-249287,

CGA-263208, CGA-232449 and NOA422054) should be monitored and

reported to the Agency.

Based on structural similarities to

genotoxic nucleotide analogs, there was

concern that the pyrimidine metabolites

(CGA-249287, NOA-422054) may be

more toxic than the parent compound.

However, EPA’s review indicates

similar results in an acute oral and

mutagenicity studies with both the

parent compound and the CGA-249287

metabolite. EPA concluded that the

toxicity of the CGA-249287 and NOA422054 metabolites is no greater than

that of the parent, conditional on

submission and review of confirmatory

data of an acute oral toxicity study and

bacterial reverse mutation assay for the

NOA-422054 metabolite. Although the

metabolites CGA-232449 and CGA263208 were determined to be of

potential toxicological concern, they are

not expected to be more toxic than

cyprodinil per se.

Upon receipt and evaluation of

additional residue field trials for

strawberries, dry bulb onions, and green

onions; field accumulation in rotational

crops study for the CGA-249287, NOA422054, CGA-263208, and CGA-232449

metabolites; and formal submission and

review of confirmatory data from an

acute oral toxicity study and Ames

assay for the CGA-249287 and NOA422054 metabolites; the Agency will

reassess these tolerances and, if

appropriate, will establish permanent

tolerances for strawberry, dry bulb

onion and green onion. A rotational

crop restriction will be imposed, which

will limit the plant-back to crops which

have established cyprodinil tolerances.

V. Conclusion

Therefore, these tolerances are

established for residues of cyprodinil, 4-

cyclopropyl-6-methyl-N-phenyl-2-

pyrimidinamine, in or on strawberry at

5.0 ppm, dry bulb onion at 0.60 ppm,

and green onion at 4.0 ppm. These

tolerances will expire on December 31,

2003.

VI. 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

Federal Register / Vol. 66, No. 121 / Friday, June 22, 2001 / Rules and Regulations 33485

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–301120 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 August 21, 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 VI.A., you should also send a copy

of your request to the PIRIB for its

inclusion in the official record that is

described in Unit I.B.2. Mail your

copies, identified by docket control

number OPP–301120, 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 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).

VII. Regulatory Assessment

Requirements

This final rule establishes a tolerance

under FFDCA section 408(d) in

response to a petition submitted to the

Agency. The Office of Management and

Budget (OMB) has exempted these types

of actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). This final rule does

not contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44

U.S.C. 3501 et seq., or impose any

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA) (Public

Law 104–4). Nor does it require any

special considerations under Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994); or OMB review or any other

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 tolerance 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

33486 Federal Register / Vol. 66, No. 121 / Friday, June 22, 2001 / Rules and Regulations

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).

For these same reasons, the Agency

has determined that this rule does not

have any ‘‘tribal implications’’ as

described in Executive Order 13175,

entitled Consultation and Coordination

with Indian Tribal Governments (65 FR

67249, November 6, 2000). Executive

Order 13175, requires EPA to develop

an accountable process to ensure

‘‘meaningful and timely input by tribal

officials in the development of

regulatory policies that have tribal

implications.’’ ‘‘Policies that have tribal

implications’’ is defined in the

Executive Order to include regulations

that have ‘‘substantial direct effects on

one or more Indian tribes, on the

relationship between the Federal

government and the Indian tribes, or on

the distribution of power and

responsibilities between the Federal

government and Indian tribes.’’ This

rule will not have substantial direct

effects on tribal governments, on the

relationship between the Federal

government and Indian tribes, or on the

distribution of power and

responsibilities between the Federal

government and Indian tribes, as

specified in Executive Order 13175.

Thus, Executive Order 13175 does not

apply to this rule.

VIII. 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: June 7, 2001.

James Jones,

Director, Registration 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), 346(a) and

371.

2. Section 180.532(a) is amended by

designating the text following the

paragraph heading as paragraph (a)(1)

and adding paragraph (a)(2) to read as

follows:

§ 180.532 Cyprodinil; tolerances for

residues.

(a) * * *

(2) Time-limited tolerances are

established for residues of the fungicide

cyprodinil, 4-cyclopropyl-6-methyl-Nphenyl-2-pyrimidinamine in or on the

following food commodities.

Commodity Parts per

million

Expiration/

revocation

date

Onion, dry bulb 0.60 12/31/03

Onion, green 4.0 12/31/03

Strawberry 5.0 12/31/03

* * * * *

[FR Doc. 01–15620 Filed 6–21–01 8:45 a.m.]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301141; FRL–6788–4]

RIN 2070–AB78

Tebufenozide; Re-establish Tolerances

for Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation re-establishes

time-limited tolerances for residues of

the insecticide tebufenozide, benzoic

acid, 3,5-dimethyl-1-(1,1-

dimethylethyl)-2-(4-

ethylbenzoyl)hydrazide in or on eggs at

0.01 part per million (ppm); grass,

forage at 5 ppm; grass, hay at 18 ppm;

hogs, liver at 1 ppm; hogs, mbyp at 0.1

ppm; peanuts at 0.05 ppm; peanut, hay

at 5 ppm; peanut, meal at 0.15 ppm;

peanut, oil at 0.15 ppm; poultry, fat at

0.1 ppm; poultry, meat at 0.01 ppm; and

poultry, mbyp at 0.05 ppm for an

additional 2–year period. These

tolerances will expire and are revoked

on June 30, 2003. This action is in

response to EPA’s granting of an

emergency exemption under section 18

of the Federal Insecticide, Fungicide,

and Rodenticide Act (FIFRA)

authorizing use of the pesticide on

peanuts and pasture. Section 408(l)(6) of

the Federal Food, Drug, and Cosmetic

Act (FFDCA) requires EPA to establish

a time-limited tolerance or exemption

from the requirement for a tolerance for

pesticide chemical residues in food that

will result from the use of a pesticide

under an emergency exemption granted

by EPA under section 18 of the FIFRA.

DATES: This regulation is effective June

22, 2001. Objections and requests for

hearings, identified by docket control

number OPP–301141, must be received

by EPA on or before August 21, 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 III. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301141 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Barbara Madden, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone