Federal Register / Vol. 65, No. 121 / Thursday, June 22, 2000 / Rules and Regulations 38757

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. 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 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

General Accounting Office

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: May 25, 2000.

Susan B. Hazen,

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. 321(q), 346(a), and

371.

2. Section 180.1201 is revised to read

as follows:

§ 180.1201 Trichoderma harzianum strain

T-39; exemption from the requirement of a

tolerance.

Trichoderma harzianum strain T-39 is

exempt from the requirement of a

tolerance on all food commodities.

[FR Doc. 00–15723 Filed 6–21–00; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301010; FRL–6592–4]

RIN 2070–AB78

Cloquintocet-mexyl; Pesticide

Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

tolerances for the combined residues of

the inert ingredient (herbicide safener)

cloquintocet-mexyl and its acid

metabolite in or on wheat grain, forage,

hay, and straw. Novartis Crop

Protection, Inc. requested this tolerance

under the Federal Food, Drug, and

Cosmetic Act, as amended by the Food

Quality Protection Act of 1996.

DATES: This regulation is effective June

22, 2000. Objections and requests for

hearings, identified by docket control

number OPP–301010, must be received

by EPA on or before August 21, 2000.

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–301010 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Treva Alston, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: 703–308–8373; and e-mail

address: alston.treva@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 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’’ 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–301010. 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

38758 Federal Register / Vol. 65, No. 121 / Thursday, June 22, 2000 / Rules and Regulations

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 April 15,

1998 (63 FR 18417) (FRL–5781–9), 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 7E4920) for tolerances by

Novartis Crop Protection, Inc., P.O. Box

18300, Greensboro, North Carolina

27419. This notice included a summary

of the petition prepared by Novartis

Crop Protection, Inc., the petitioner. The

petition was subsequently amended to

increase the original proposed

tolerances and an additional notice of

filing was published in the Federal

Register on April 19, 2000 (65 FR

20972). There were no comments

received in response to the notice of

filing.

The April 19, 2000 (FRL–6554–3)

petition requested that 40 CFR part 180

be amended by establishing tolerances

for combined residues of the inert

ingredient (herbicide safener)

cloquintocet-mexyl (acetic acid, [(5-

chloro-8-quinolinyl)oxy]-, 1-

methylhexyl ester) and its acid

metabolite (5-chloro-8-

quinolinoxyacetic acid), in or on wheat,

grain at 0.1 parts per million (ppm);

wheat, forage at 0.1 ppm; and wheat,

hay at 0.1 ppm and wheat, straw at 0.1

ppm.

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 a tolerance for

combined residues of cloquintocetmexyl and its acid metabolite) on wheat,

grain at 0.1 ppm; wheat, forage at 0.1

ppm; wheat, hay at 0.1 ppm; and wheat,

straw at 0.1 ppm. EPA’s assessment of

exposures and risks associated with

establishing the tolerance follows.

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered its validity,

completeness, and reliability as well as

the relationship of the results of the

studies to human risk. EPA has also

considered available information

concerning the variability of the

sensitivities of major identifiable

subgroups of consumers, including

infants and children. The nature of the

toxic effects caused by cloquintocetmexyl are discussed in this unit 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

870.3100 28-Day Oral in Rodents .......... NOAEL = 10 mg/kg/day

LOAEL = 100 mg/kg/day based on microscopic kidney lesions.

870.3100 28-Day Oral in Rodents .......... NOAEL = 10 mg/kg/day (females only)

LOAEL = 400 mg/kg/day based on transient decrease in body weight gain, microscopic alterations of

the pituitary and thyroid and possible increased SGPT.

870.3100 90-Day Oral Toxicity Rodents NOAEL = males: 150 ppm (9.7 mg/kg/day), females: 6,000 ppm (407) mg/kg/day

LOAEL = males: 1000 ppm (63.9 mg/kg/day); females: ≥ 6,000 ppm (≥ 407 mg/kg/day based on urinary bladder hyerplasia, kidney hydronephrosis and increased serum bilirubin in males.

870.3150 90-Day Oral Toxicity in Nonrodents.NOAEL = 100 ppm (2.9 mg/kg/day in males and 3.3 mg/kg/day in females)

LOAEL = 1,000 ppm ( 30.2 mg/kg/day in males and females based on perivascular mixed inflammatory cell infiltrates and multicellular multifocal necrosis of the liver and thymic atrophy.

870.3200 28-Day Dermal Toxicity .......... NOAEL = 200 mg/kg/day

LOAEL = 1,000 mg/kg/day based on mottled or reddish livers accompanied by histopathological

changes including necrosis and fibrosis.

Federal Register / Vol. 65, No. 121 / Thursday, June 22, 2000 / Rules and Regulations 38759

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

Guideline No./Study Type Results

870.3700a Prenatal Developmental in

Rodents.

Maternal NOAEL = 100 mg/kg/day

LOAEL = 400 mg/kg/day based on clinical signs and decrease in body weight gain and food consumption.

Developmental NOAEL = 100 mg/kg/day

LOAEL = 400 mg/kg/day based on the higher incidence of skeletal variants and decrease in fetal

body weights in the high dose group.

870.3700b Prenatal Developmental in

Nonrodents.

Maternal NOAEL = 60 mg/kg/day

LOAEL = 300 mg/kg/day based on maternal toxicity (death) in high dose group.

Developmental NOAEL = 300 mg/kg/day

LOAEL ‘‘ 300 mg/kg/day

870.3800 Reproduction and Fertility Effects.Parental/Systemic NOAEL = 5,000 ppm (males: 370.7 mg/kg/day; females: 442.8 mg/kg/day

LOAEL = 10,000 ppm (males: 721.7 mg/kg/day; females: 846.9 mg/kg/day based on decreased body

weight, decreased food consumption, and pathological changes in the kidney (dilated renal pelvis,

nephrolith, hydronephrosis, urethral constrictions) and urinary bladder (cytoliths, hyperemia, cystitis

and urothelial hyperplasia).

Reproductive NOAEL = 10,000 ppm (721.7 mg/kg/day)

LOAEL = 10,000 ppm (721.7) mg/kg/day.

Developmental NOAEL = 5,000 ppm (442.8) mg/kg/day

LOAEL = 10,000 ppm (846.9 mg/kg/day based on decreased pup weight and dilated renal pelvis.

870.4100b Chronic Toxicity in Nonrodents.NOAEL = 1,500 ppm (males: 43 mg/kg/day; females: 45 mg/kg/day

LOAEL = 15,000/10,000 ppm M: 196 F: 216 mg/kg/day based on decreased body weight/weight gain

and food consumption, anemia, increased serum iron, protein alterations, bone marrow hypoplasia

and possible decreased testes/prostate weights and interstitial nephritis.

870.4200 Carcinogenicity Mice ............... NOAEL = 1,000 ppm (males: 111 mg/kg/day; females: 102 mg/kg/day

LOAEL = 5,000 ppm (males: 583 mg/kg/day; females: 520 mg/kg/day based on decreased body

weight/weight gain in both sexes, urinary bladder lesions (chronic inflammation, ulceration, calculus

and submucosa edema) in males and possible slightly increased water consumption in both sexes.

Negative for oncogenicity.

870.4300 Combined Chronic/

oncogenicity in rat.

NOAEL = females: 100 ppm (4.3 mg/kg/day); males: 1,000 ppm 36.4 mg/kg/day).

LOAEL = females: 1,000 ppm (41.2 mg/kg/day); males: 2,000 ppm (81.5 mg/kg/day) based on increased incidence of thyroid follicular epithelial hyperplasia in females and based on lymphoid

hyperplasis of the thymus in males.

870.5100 Gene Mutation ........................ Testing up to 5,000 μg/plate with or without S9 microsomes produces no evidence that cloquintocetmexyl technical induced a mutagenic effect in any strain. Negative mutagen.

870.5200 Gene Mutation ........................ There was no evidence of any mutagenic effect at any dose (up to 500 μg/plate) with or without S9

activation. Negative mutagen.

870.5375 Human Lymphocytes in vitro .. Human lymphocytes were exposed in vitro up to 75 μg/mL with or without S9 activation showed no

evidence of inducing a cytogenetic effect at any dose. Negative mutagen.

870.5395 Micronucleus Test ................... Chinese hamsters dosed from 625 to 2,000 mg/kg showed no evidence of inducing a clastogenic or

aneugenic effect in either sex at any dose or sacrifice time. Negative mutagen.

870.5550 DNA Repair Human Fibroblasts.Cultured human fibrocytes were exposed in vitro to up to 60 μg/mL for 5 hrs. and scored for silver

grains in the nucleus. There was no evidence that cloquintocet-mexyl technical in the absence of

S9 activation induced a genotoxic response.

870.5550 DNA Repair Rat Hepatocytes Primary rat hepatocytes exposed to 200 μg/mL for 16–18 hours and scored for nuclear grain showed

no evidence that cloquintocet-mexyl technical induced a genotoxic response. Negative mutagen.

870.7485 Metabolism and

pharmcokinetics.

Absorption after a single low oral dose (50 mg/kg bw), was between 40.2% (males) and 35.6% (females). The major metabolite in the 0 to 24 hour fecal and urinary pools was determined to be

quinolinoxy acetic acid, accounting for approximately 95% of the recovered radioactivity.

870.7485 Metabolism and pharmacokinetics.The major metabolic pathway was determined to be hydrolysis of the ester group, resulting in the formation of 5-chloro-8-quinolinoxy acetic acid. The major metabolic pathway was not significantly affected by sex, dose level or dosing regime.

B. Toxicological Endpoints

The dose at which no observed

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

38760 Federal Register / Vol. 65, No. 121 / Thursday, June 22, 2000 / Rules and Regulations

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 × 106 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 (MOEcancer = point

of departure/exposures) is calculated.

TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR CLOQUINTOCET-MEXYL FOR USE IN HUMAN RISK

ASSESSMENT

Exposure Scenario Dose Used in Risk

Assessment, UF

FQPA SF 1 and Level of

Concern for Risk

Assessment

Study and Toxicological Effects

Acute Dietary females 13–50

years of age.

NOAEL = 100 mg/kg/day.

UF =100 ..............................

Acute RfD = 1.0 mg/kg/day

FQPA SF = 1x

aPAD = acute RfD/FQPA ...

SF = 1.0 mg/kg/day ............

Developmental toxicity study in rats.

LOAEL = 400 mg/kg/day based on higher incidence of skeletal variants and decrease in

fetal body weights.

Acute Dietary general population

including infants and children.

None Not applicable Not applicable.

Chronic Dietary all populations .. NOAEL = 4.3 mg/kg/day.

UF = 100 .............................

Chronic RfD = 0.04 mg/kg/

day.

FQPA SF = 1x

cPAD = chronic RfD/FQPA

SF = 0.04 mg/kg/day ..........

Chronic/Oncogenicity Toxicity-Rats LOAEL =

41.2 mg/kg/day based on observation of thyroid hyperplasia in females.

Short-Term Dermal (1 to 7 days) Dermal NOAEL = 200 mg/

kg/day.

LOC for MOE = 100. 28-Day Dermal Toxicity-Rats.

LOAEL = 1,000 mg/kg/day based on mottled or

reddish livers accompanied by histopathological changes including necrosis and fibrosis

in two of five female rats.

Intermediate-Term Dermal (1

week to several months).

Dermal NOAEL = 200 mg/

kg/day.

LOC for MOE = 100. 28-Day Dermal Toxicity-Rats LOAEL = 1,000

mg/kg/day based on mottled or reddish livers

accompanied by histopathological changes including necrosis and fibrosis in two of five female rats.

Long-Term Dermal (several

months to lifetime).

None Not applicable Based on the current use pattern, no long-term

dermal exposure is expected to occur.

Short-Term Inhalation (1 to 7

days).

Oral NOAEL = 100 mg/kg/

day.

absorption rate = 100% ......

LOC for MOE = 100. Developmental toxicity study in rats LOAEL =

400 mg/kg/day based on higher incidence of

skeletal variants and decrease in fetal body

weights in the high dose group.

Intermediate-Term Inhalation (1

week to several months).

Oral NOAEL = 4.3 mg/kg/

day.

absorption rate = 100% ......

LOC for MOE = 100 Chronic/Oncogenicity Toxicity Rat.

LOAEL = 41.2 mg/kg/day based on observation

of thyroid hyperplasia in females.

Long-Term Inhalation (several

months to lifetime).

None Not applicable Based on the current use pattern, no long-term

inhalation exposure is expected to occur.

1The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique to the FQPA.

In accordance with the Proposed EPA

Weight-of-the-Evidence Categories,

August 1999, the Agency classified

cloquintocet-mexyl as ‘‘not likely to be

a human carcinogen’’. Carcinogenicity

studies in rats and mice did not show

increased incidence of spontaneous

tumor formation. With negative

mutagenicity test battery, it is suggested

that cloquintocet-mexyl is not likely to

be a human carcinogen.

Federal Register / Vol. 65, No. 121 / Thursday, June 22, 2000 / Rules and Regulations 38761

C. Exposure Assessment

1. Dietary exposure from food and

feed uses. No tolerances have previously

been established for the combined

residues of cloquintocet-mexyl and its

acid metabolite 5-chloro-8-

quinolinoxyacetic acid. A risk

assessment was conducted by EPA to

assess dietary exposures from

cloquintocet-mexyl and its acid

metabolite 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 one

day or single exposure. The Agency has

conducted Tier 1 acute food exposure

assessments for cloquintocet-mexyl

using the Dietary Exposure Evaluation

Model (DEEM). This model incorporates

consumption data generated in USDA’s

Continuing Surveys of Food Intakes by

Individuals (CSFII), 1989–1992. For this

acute food risk assessment, the entire

distribution of single day food

consumption events is combined with a

single residue level (deterministic

analysis ) to obtain a distribution of

exposure in mg/kg/day. For a Tier 1

analysis, the Agency considers exposure

at the 95th percentile of exposure. The

following assumptions were made for

the Tier 1 acute exposure assessment:

(1) Residues of cloquintocet-mexyl and

its acid metabolite would be present in/

on wheat at the tolerance level (0.1

ppm); and (2) 100% of the wheat crop

would be treated.

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. For

chronic food risk assessments, the threeday average of consumption for each

sub-population is combined with

residues in commodities to determine

average exposure in mg/kg/day. The

following assumptions were made for

the chronic exposure assessments: (1)

Residues of cloquintocet-mexyl and its

acid metabolite would be present in/on

wheat at the tolerance level (0.1 ppm);

and (2) 100% of the wheat crop would

be treated.

2. Dietary exposure from drinking

water. The Agency lacks sufficient

monitoring exposure data to complete a

comprehensive dietary exposure

analysis and risk assessment for

cloquintocet-mexyl and its acid

metabolite 5-chloro-8-quinolinoxyacetic

acid 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 cloquintocet-mexyl

and its acid metabolite.

The Agency uses the Generic

Estimated Environmental Concentration

(GENEEC) to estimate pesticide

concentrations in surface water and SCIGROW, which predicts pesticide

concentrations in groundwater. 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.

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 cloquintocetmexyl and its acid metabolite 5-chloroquinolinoxyacetic acid they are further

discussed in the aggregate risk sections

below.

Based on the GENEEC and SCI-GROW

models the estimated environmental

concentrations (EECs) of cloquintocetmexyl in surface water and ground

water for acute exposures are estimated

to be 0.038 parts per billion (ppb) for

surface water and 0.0060 ppb for ground

water. The EECs for chronic exposures

are estimated to be 0.0053 ppb for

surface water and 0.0060 ppb for ground

water. The EECs for ground water for

the acid metabolite for acute and

chronic exposures are estimated to be

0.00017 ppb. The EEC for surface water

for acute exposure for the acid

metabolite is estimated to be 0.031 ppb,

while the chronic exposure is estimated

to be 0.017 ppb for surface 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).

Cloquintocet-mexyl 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

cloquintocet-mexyl 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, cloquintocetmexyl 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 cloquintocet-mexyl 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

38762 Federal Register / Vol. 65, No. 121 / Thursday, June 22, 2000 / Rules and Regulations

using uncertainty (safety) factors in

calculating a dose level that poses no

appreciable risk to humans.

ii. Prenatal and postnatal sensitivity.

There was no evidence of

developmental or reproductive toxicity

for cloquintocet-mexyl. The data

demonstrate no increased sensitivity of

rats or rabbits to in utero or early postnatal exposure to cloquintocet-mexyl.

NOAELs for maternal/parental toxicity

were either less than or equal to the

NOAELs for fetal or reproductive

toxicity.

iii. Conclusion. There is a complete

toxicity data base for cloquintocetmexyl. Exposure data are complete or

are estimated based on data that

reasonably accounts for potential

exposures. EPA has determined that the

10X safety factor to protect infants and

children should be removed (i.e.,

reduced to 1X) because the toxicology

database (i.e., developmental toxicity

studies in rats and rabbits; 2-generation

reproduction study in rats) is complete,

and there is no indication of

quantitative or qualitative increased

susceptibility of rats or rabbits in the

available toxicity data.

E. Aggregate Risks and Determination of

Safety

The following text is based on the

assumption that water models were

used to estimate residues in drinking

water. If exposure to residues in

drinking water is not expected, delete

the following three paragraphs. If

exposure is based on monitoring data,

the text must be revised.

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

are used 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

groundwater 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

impacts of residues of the pesticide in

drinking water as a part of the aggregate

risk assessment process.

1. Acute risk. Using the exposure

assumptions discussed in this unit for

acute exposure, the acute dietary

exposure from food to cloquintocetmexyl and its acid metabolite will

occupy < 1.0 % of the aPAD for females

13–50 years. In addition, there is

potential for acute dietary exposure to

cloquintocet-mexyl and its acid

metabolite in drinking water. The acute

DWLOC for the population subgroups

females of child-bearing age is 30,000

ppb. After calculating the acute DWLOC

and comparing the EECs for surface and

ground water, EPA does not expect the

aggregate exposure to exceed 100% of

the aPAD since the DWLOC greatly

exceeds the EEC.

2. Chronic risk. Using the exposure

assumptions described in this unit for

chronic exposure, EPA has concluded

that exposure to cloquintocet-mexyl and

its acid metabolite from food will utilize

< 1 % of the cPAD for the U.S.

population, infants (< 1 year), and male

and female adult populations. Exposure

from food will utilize 1 % of the cPAD

for children (1–6) and (7–12 years).

There are no residential uses for

cloquintocet-mexyl that result in

chronic residential exposure.

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

Population Subgroup 1 cPAD mg/

kg/day

% cPAD

(Food)

Surface

Water EEC

(ppb)

Ground

Water EEC

(ppb)

Chronic

DWLOC

(ppb)

U.S. Population ......................................................................................... 0.04 <1.0 0.0053 0.0060 1,400

Children 1–6 ............................................................................................. 0.04 1.0 0.0053 0.0060 400

Females 13+ Nursing ............................................................................... 0.04 < 1.0 0.0053 0.0060 1,200

Males 13–19 ............................................................................................. 0.04 < 1.0 0.0053 0.0060 1,400

1For all population subgroups, EPA does not expect the aggregate exposure to exceed 100% of a cPAD since the DWLOC greatly exceeds

the EEC.

3. Short-term risk. Short-term

aggregate exposure takes into account

residential exposure plus chronic

exposure to food and water (considered

to be a background exposure level).

Cloquintocet-mexyl 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. Intermediate-term risk.

Intermediate-term aggregate exposure

takes into account residential exposure

plus chronic exposure to food and water

(considered to be a background

exposure level). There are no

established residential uses for

cloquintocet-mexyl.

Cloquintocet-mexyl 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.

5. Aggregate cancer risk for U.S.

population.Cloquintocet-mexyl is

classified as ‘‘not likely’’ to be a human

carcinogen. Therefore, cloquintocetVerDate 11<MAY>2000 14:23 Jun 21, 2000 Jkt 190000 PO 00000 Frm 00048 Fmt 4700 Sfmt 4700 E:\FR\FM\22JNR1.SGM pfrm07 PsN: 22JNR1
Federal Register / Vol. 65, No. 121 / Thursday, June 22, 2000 / Rules and Regulations 38763

mexyl is not expected to pose a cancer

risk.

6. 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 residues of

cloquintocet-mexyl and its acid

metabolite.

IV. Other Considerations

A. Analytical Enforcement Methodology

The petitioner has proposed residue

analytical methods for tolerance

enforcement that use high performance

liquid chromatography with UV

detection (HPLC-UV). These methods

are currently being validated by the

Analytical Chemistry Branch

laboratories, BEAD (7503C), Office of

Pesticide Programs. Upon successful

completion of the EPA validation, these

methods will be forwarded to FDA for

publication in a future revision of the

Pesticide Analytical Manual. Vol-II

(PAM-II). Prior to publication in PAMII and upon request, the methods will be

available prior to the harvest season

from the Analytical Chemistry Branch

(ACB), BEAD (7503C), Environmental

Science Center, 701 Mapes Road, Fort

George G. Meade, MD 20755–5350;

contact Francis D. Griffith, Jr., telephone

(410) 305–2905, e-mail griffith.francis

@epa.gov. The analytical standards for

these methods are also available from

the EPA National Pesticide Standard

Repository at the same location.

B. International Residue Limits

There are no Codex, Canadian, or

Mexican tolerances for cloquintocetmexyl on wheat. Therefore, no

compatibility issues exist.

C. Conditions

The following residue chemistry data

gaps have been identified for

cloquintocet mexyl: (1) additional wheat

metabolism data; (2) additional

information on meat, milk, poultry, and

egg analyses; (3) storage stability data;

and (4) additional field trial residue

studies. Because of these deficiencies,

the Agency incorporated several

conservative assumptions into the risk

assessment for cloquintocet-mexyl. The

Agency believes that the available data

and risk assessment support the

determination that there is a reasonable

certainty of no harm and the

establishment of permanent tolerances

for cloquintocet-mexyl.

Cloquintocet-mexyl will be used with

the active ingredient, clodinafoppropargyl. The registration of

clodinafop-propargyl will be timelimited and conditional upon

submission of additional information/

data to satisfy certain toxicology,

residue chemistry, ecological effects,

and environmental fate data

deficiencies. Several guideline

requirements are either data gaps or are

only partially fulfilled, and the

additional information is required to

confirm and/or refine the parameters of

the Agency’s risk assessment. The

required data for both cloquintocetmexyl and clodinafop-propargyl must

be submitted to maintain this

registration.

V. Conclusion

Therefore, the tolerances are

established for combined residues of

cloquintocet-mexyl (acetic acid, [(5-

chloro-8-quinolinyl)oxy]-, 1-

methylhexyl ester) and its acid

metabolite (5-chloro-8-quinolinoxy

acetic acid), in or on wheat, grain at 0.1

ppm (parts per million); wheat, forage at

0.1 ppm; wheat, hay at 0.1 ppm; and

wheat, straw at 0.1 ppm.

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

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–301010 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, 2000.

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 judgment 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.

38764 Federal Register / Vol. 65, No. 121 / Thursday, June 22, 2000 / Rules and Regulations

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–301010, 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).

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

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 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

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).

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 6, 2000.

Susan B. Hazen

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. 321(q), (346a) and

371.

2. Section 180.560 is added to read as

follows:

§ 180.560 Cloquintocet-mexyl; tolerances

for residues.

(a) General. Tolerances are

established for the combined residues of

cloquintocet-mexyl (acetic acid, [(5-

chloro-8-quniolinyl)oxy]-, 1-

methylhexyl ester)(CAS Reg. No. 99607–

70–2) and its acid metabolite (5-chloro8-quinlinoxyacetic acid) when used as

an inert ingredient (safener) in pesticide

formulations containing the herbicide,

clodinafop-propargyl in a 1:4 ratio of

safener to active ingredient in or on the

following food commodities:

Commodity Parts per

million

Wheat, forage ............................... 0.1

Wheat, straw ................................. 0.1

Wheat, hay ................................... 0.1

Wheat, grain ................................. 0.1

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 00–15716 Filed 6–21–00; 8:45 am]

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