Federal Register / Vol. 66, No. 120 / Thursday, June 21, 2001 / Rules and Regulations 33187

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 11, 2001.

Peter Caulkins,

Acting 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 180.570 is added to read as

follows:

§ 180.570 Isoxadifen-ethyl; tolerances for

residues.

(a) General. Tolerances to expire on

June 21, 2004 are established for

residues of isoxadifen-ethyl (ethyl 5,5-

diphenyl-2-isoxazoline-3-carboxylate,

CAS No. 163520–33–0) and its

metabolites: 4,5-dihydro-5,5-diphenyl-3-

isoxazolecarboxylic acid and β-hydroxyβ-benezenepropanenitrile when in the

commodities listed below. This safener

will be used only in conjunction with

the active ingredient fenoxaprop-pethyl, at a rate of 0.17 pound of safener

per pound of active ingredient.

Commodity Parts per million Expiration/Revocation Date

Rice, bran ............................... 0.80 ppm June 21, 2004

Rice, grain .............................. 0.10 ppm June 21, 2004

Rice, hulls ............................... 0.50 ppm June 21, 2004

Rice, straw .............................. 0.25 ppm June 21, 2004

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 01–15613 Filed 6–20–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301138; FRL–6787–7]

RIN 2070–AB78

Mesotrione; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

tolerance for residues ofmesotrione, 2-

[4-(methylsulfonyl)-2-nitrobenzoyl]-1,3-

cyclohexanedione, in or on field corn.

Syngenta 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

21, 2001. Objections and requests for

hearings, identified by docket control

number OPP–301138, must be received

by EPA on or before August 20, 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 numberOPP–301138 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Joanne Miller,Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave.,

NW.,Washington, DC 20460; telephone

number: 703-305-6224; and e-mail

address: Miller.Joanne@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

33188 Federal Register / Vol. 66, No. 120 / Thursday, June 21, 2001 / Rules and Regulations

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

t certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically.You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations’’, ‘‘Regulations

and Proposed Rules,’’ and then look up

the entry for this document under the

‘‘Federal Register—-Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/. To access the

OPPTS Harmonized Guidelines

referenced in this document, go directly

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

opptsfrs/home/guidelin.htm. A

frequently updated electronic version of

40 CFR part 180 is available at http://

www.access.gpo.gov/nara/cfr/

cfrhtml_180/Title_40/40cfr180_00.

html, a beta site currently under

development.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–301138. 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 May 29,

1998 (63 FR 29401) (FRL–5791–2), 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 8F4954) for tolerance by

Zeneca Ag Products, 1800 Concord Pike,

Wilmington, DE 19850–5458. This

notice included a summary of the

petition prepared by Zeneca Ag

Products, the registrant. There were no

comments received in response to the

notice of filing. The petition was

subsequently transferred to Syngenta

Crop Protection Inc., 410 Swing Road,

PO Box 18300, Greensboro, NC 27419–

8300

The petition requested that 40 CFR

part 180 be amended by establishing a

tolerance for residues of the herbicide 2-

[4-(methylsulfonyl)-2-nitrobenzoyl]-1,3-

cyclohexanedione, in or on the raw

agricultural commodities field corn,

field corn fodder and field corn forage

at 0.01 part per million (ppm). EPA is

editorially correcting the tolerances

expression to read: field corn grain, field

corn forage and field corn stover at 0.01

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

residues of mesotrione, 2-[4-

(methylsulfonyl)-2-nitrobenzoyl]-1,3-

cyclohexanedione, in or on field corn

grain, field corn forage and field corn

stover at 0.01 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 mesotrione 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

870.3100 90–Day oral toxicity rodents (rat)NOAEL = 0.41/0.47 milligram (mg)/kilogram (kg)/day (males [M]/females [F])

LOAEL = 0.63/0.71 mg/kg/day (M/F), based upon corneal lesion in males

Federal Register / Vol. 66, No. 120 / Thursday, June 21, 2001 / Rules and Regulations 33189

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

Guideline No. Study Type Results

870.3100 90–Day oral toxicity rodents (rat)NOAEL = 0.09/0.10 mg/kg/day (M/F)

LOAEL = 11/13 mg/kg/day (M/F), based upon corneal abnormalities in both sexes

and decreased body weight gain in males

870.3100 90–Day oral toxicity rodents (mouse)NOAEL = 1212/1537 mg/kg/day (M/F)

LOAEL greater than (>) 1212/1537 mg/kg/day (M/F). No effects noted

870.3150 90–Day oral toxicity in

nonrodents (dog)

NOAEL = 1,000 mg/kg/day (M/F)

LOAEL > 1,000 mg/kg/day (M/F) No effects noted

870.3200 21/28–Day dermal toxicity

(rabbit)

NOAEL = 1,000 mg/kg/day (M/F)

LOAEL > 1,000 mg/kg/day (M/F). No systemic effects noted

870.3700a Prenatal developmental in

rodents (rat)

Maternal NOAEL = 100 mg/kg/day

LOAEL = 300 mg/kg/day, based upon decreased maternal body weight gains during

treatment and decreased food consumption

Developmental NOAEL was not established

LOAEL = 100 mg/kg/day, based upon delays in skeletal ossification and changes in

manus⁄pes ossification assessments

870.3700a Prenatal developmental in

rodents (mouse)

Maternal NOAEL = 600 mg/kg/day

LOAEL >600 mg/kg/day; No effects noted

Developmental NOAEL = 150 mg/kg/day

LOAEL = 600 mg/kg/day, based upon decreased ossification of the cervical vertebrae

centra

870.3800 Reproduction and fertility

effects (rat)

Parental/Systemic NOAEL was not established

LOAEL = 0.3 mg/kg/day (M/F), based upon significantly increased plasma tyrosine

levels and increased liver weights in F2 males

Offspring/Systemic NOAEL not established

LOAEL = 0.3 mg/kg/day (M/F), based upon significantly increased plasma tyrosine

levels in F2 male pups

Reproductive NOAEL = 0.3 mg/kg/day

LOAEL = 1.1/1.2 mg/kg/day (M/F), based upon decreased F2 mean litter size

870.3800 Reproduction and fertility

effects (mouse)

Parental/Systemic NOAEL = 10.1/11.7 mg/kg/day (M/F)

LOAEL = 71.4/82.5 mg/kg/day (M/F), based upon increased kidney weights and

tyrosinemia in the and F1 males

Offspring/Systemic NOAEL not established

LOAEL = 2.1/2.4 mg/kg/day (M/F), based upon tyrosinemia and ocular discharge in

the F1 and F2 offspring

Reproductive NOAEL = 1455.5/1652.3 mg/kg/day (M/F)

LOAEL > 1455.5/1652.3 mg/kg/day

870.4100a Chronic toxicity rodents

(mouse)

NOAEL = 56.2/72.4 mg/kg/day (M/F)

LOAEL = 1114/1494.5 mg/kg/day (M/F), based upon decreases in body weight gain

and food utilization in males

870.4100b Chronic toxicity dogs NOAEL was not established

LOAEL = 10 mg/kg/day, based upon evidence of tyrosinemia in both sexes and increased incidence of erythrophagocytosis in the mesenteric lymph nodes of females

870.4300 Combined chronic toxicity/

carcinogenicity rodents

(rat)

NOAEL was not established

NOAEL = 0.16/0.19 mg/kg/day (M/F) ocular lesions only]

LOAEL = 0.16/0.19 mg/kg/day based kidney and liver weights or hepatocyte fat

vacuolation in males

LOAEL = 0.48/0.57 mg/kg/day (M/F), based upon ocular lesions, increases in kidney

and liver weights, and hepatocyte fat vacuolation in females

No evidence of carcinogenicity

870.4300 Carcinogenicity mice NOAEL = 49.7/63.5 mg/kg/day (M/F)

33190 Federal Register / Vol. 66, No. 120 / Thursday, June 21, 2001 / Rules and Regulations

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

Guideline No. Study Type Results

LOAEL = 898/1103 mg/kg/day (M/F), based upon decreased body weight, body

weight gain, and food efficiency in males

No evidence of carcinogenicity

870.5100 Gene Mutation reverse

gene mutation assay in

bacteria

There was no evidence of induced mutant colonies over background

870.5300 Gene Mutation in vitro forward gene mutation

assay in mouse

lymphoma cells

There were no treatment-related increases in mutant frequency in the presence or

absence of S9 activation

870.5375 Cytogenetics in vitro mammalian cytogenetics

assay

Not clastogenic with S9 activation and equivocal for clastogenic activity without S9

activation

870.5395 bone marrow micronucleus assayThere was no significant increase in the frequency of micronucleated polychromatic

erythrocytes in bone marrow after any treatment time.

870.6200a Acute neurotoxicity

screening battery

NOAEL = 2,000 mg/kg/day (M/F)

LOAEL > 2,000 mg/kg/day (M/F)

No effects noted

870.6200b Subchronic neurotoxicity

screening battery

NOAEL = 0.20/0.23 mg/kg/day (M/F)

LOAEL = 8.25/9.29 mg/kg/day (M/F), based upon corneal opacities and/or

vascularization of the cornea of the eye in males

870.7485 Metabolism rat Mesotrione was readily absorbed and distributed in the body. Tissue distribution was

about the same in both sexes, although one study showed higher residues in the

kidneys in females, with the highest residues of the test compound in the liver and

kidney. Higher doses resulted in higher residues in the liver and kidney, while repeated doses resulted in reduced accumulation of residues in all tissues. Levels of

radioactivity in tissues of iv-dosed animals were essentially the same as in orallydosed animals. Over 50% of the administered dose was excreted in the urine in

both sexes and around 25% was excreted in the feces within 72 hours. Females

exhibited slightly higher total urinary excretion than males, but total fecal excretion

was about the same in both sexes. Increasing the dose or repeated doses had little effect on the pattern of excretion in both sexes. The overall pattern of excretion

was similar between orally-dosed and iv-dosed rats. The metabolite profile was

similar between the sexes in each group and between the single-dosed and repeated-dosed animals. The parent compound, mesotrione, was the major component identified in the urine (> 47%) and feces (> 55%). Minor metabolites identified

were MNBA, AMBA, 5-hydroxymesotrione, and 4-hydroxymesotrione.

870.7485 Metabolism mouse Metabolism in the mouse was very similar to the rat (above) except that males had

slightly increased total fecal excretion when compared to females and, females in

the low-dose group excreted higher (1.5x) levels of parent compound in the urine

than males. Free mesotrione was the major component in the urine and feces (≥

50% of the dose). Minor components in the fecal extracts included AMBA and

MNBA.

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

intra species differences. A UF of 3 is

used if no NOAEL was achieved in the

toxicology study.

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

Federal Register / Vol. 66, No. 120 / Thursday, June 21, 2001 / Rules and Regulations 33191

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 (MOEcancer = point

of departure/exposures) is calculated. A

summary of the toxicological endpoints

for mesotrione used for human risk

assessment is shown in the following

Table 2:

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

ASSESSMENT

Exposure Scenario Dose Used in Risk Assessment, UF

FQPA SF* and Level of

Concern for Risk AssessmentStudy and Toxicological Effects

Acute Dietary all populations Not Applicable Not Applicable No appropriate study available.

Chronic Dietary all populations LOAEL= 2.1 mg/kg/day; UF

= 300 [10 x 3]; Chronic

RfD = 0.007 mg/kg/day

FQPA SF = 10X; cPAD =

chronic RfD/FQPA SF =

0.0007 mg/kg/day

Reproduction Study - mouse

Offspring LOAEL = 2.1 mg/kg/day based upon

tyrosinemia in F1 and F2a offspring and ocular discharge in F1 pups**.

Oral, Short-term (1-7 days)

(Residential)

No residential uses. An endpoint was not proposed/selected.

Oral, Intermediate-term (1 week

- several months) (Residential)

No residential uses. An endpoint was not proposed/selected.

Cancer (oral, dermal, inhalation) not likely Not Applicable Acceptable oral rat and mouse carcinogenicity

studies; no evidence of carcinogenic or mutagenic potential.

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

** Plasma tyrosine levels were increased in the rat, mouse and dog in the chronic and reproduction studies in which levels were measured.

The ocular, liver and kidney effects are believed to be mediated by the high tyrosine levels in the blood caused by inhibition of the enzyme 4-

hydroxyphenylpyruvate dioxygenase (HPPD). Even though the rat is the most sensitive species to this effect compared to the dog and the

mouse, EPA concludes that the mouse is a more appropriate model for assessing human risk than is the rat.

C. Exposure Assessment

1. Dietary exposure from food and

feed uses. No tolerances have been

previously established (40 CFR part 180)

for residues of mesotrione in or on any

variety of raw agricultural commodities.

Risk assessments were conducted by

EPA to assess dietary exposures from

mesotrione 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. No appropriate

study available show any acute dietary

effects of concern.

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:

residue levels are at the recommended

tolerances for field corn, and 100% of

the crop field corn is treated with

mesotrione. The %cPAD for the general

U.S. population is 1.8% and for the

most sensitive population subgroups,

All Infants (< 1 year old), is 4.3%.

iii. Cancer. Acceptable oral rat and

mouse carcinogenicity studies showed

no evidence of carcinogenic or

mutagenic potential.

2. Dietary exposure from drinking

water. The Agency lacks sufficient

monitoring exposure data to complete a

comprehensive dietary exposure

analysis and risk assessment for

mesotrione 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

mesotrione.

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 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, 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

33192 Federal Register / Vol. 66, No. 120 / Thursday, June 21, 2001 / Rules and Regulations

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 mesotrione

they are further discussed in the

aggregate risk sections below.

Based on the GENEEC (Version 1.2)

and SCI-GROW models the estimated

environmental concentrations (EECs) of

mesotrione for acute exposures are

estimated to be 20 parts per billion

(ppb) for surface water and 0.15 ppb for

ground water. The EECs for chronic

exposures are estimated to be 4.3 ppb

for surface water and 0.15 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).

Mesotrione 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

mesotrione 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,

mesotrione 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 mesotrione 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 quantitative evidence of

increased susceptibility demonstrated in

the oral prenatal developmental toxicity

studies in rats, mice, and rabbits.

Delayed ossification was seen in the

fetuses at doses below those at which

maternal toxic effects were noted.

Maternal toxic effects in the rat were

decreased body weight gain during

treatment and decreased food

consumption and in the rabbit,

abortions and GI effects.

2. Conclusion. The FQPA safety factor

(10x) is retained in assessing the risk

posed because there is quantitative

evidence of increased susceptibility of

the young exposed to mesotrione in the

prenatal developmental toxicity studies

in mice, rats, and rabbits and in the

multi-generation reproduction study in

mice, there is qualitative evidence of

increased susceptibility of the young

exposed to mesotrione in the multigeneration reproduction study in rats;

and a Developmental Neurotoxicity

Study is required to assess the effects of

tyrosinemia on the developing nervous

system exposed to mesotrione.

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 drinking water level of

comparison (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. Acute doses and

endpoints were not selected for the

general U.S. population (including

infants and children) or the females 13–

50 years old population subgroup for

mesotrione; therefore, an acute dietary

exposure analysis was not performed.

2. Chronic risk. Using the exposure

assumptions described in this unit for

chronic exposure, EPA has concluded

that exposure to mesotrione from food

will utilize 1.8% of the cPAD for the

U.S. population, 4.3% of the cPAD for

Federal Register / Vol. 66, No. 120 / Thursday, June 21, 2001 / Rules and Regulations 33193

All Infants (< 1 year old) and 4.2% of

the cPAD for Children 1–6 years old.

There are no residential uses for

mesotrione that result in chronic

residential exposure to mesotrione.

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

Population Subgroup cPAD mg/

kg/day

% cPAD

(Food)

Surface

Water EEC

(ppb)

Ground

Water EEC

(ppb)

Chronic

DWLOC

(ppb)

U.S. Population 0.0007 1.8 4.3 0.15 24

All infants (< 1 year old) 0.0007 4.3 4.3 0.15 6.7

Children (1–6 years old) 0.0007 4.2 4.3 0.15 6.7

Females (13–50 years old) 0.0007 1.4 4.3 0.15 21

Mesotrione 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.

3. Aggregate cancer risk for U.S.

population. Based on the lack of

carcinogenic response in rats and mice

and the lack of mutagenic effects, and

that there are no data in the literature or

SAR information to indicate

carcinogenic potential, no cancer risk is

posed.

4. 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 mesotrione

residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology

(high pressure liquid chromatography)

is available to enforce the tolerance

expression. 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 tolerances/Maximum Residue

Levels for mesotrione residues. Thus,

harmonization is not an issue at this

time.

C. Conditions

Conversion of the mesotrione

registration to unconditional under

section 3(c)(5) of Federal Insecticide and

Fungicide Act (FIFRA) as amended may

be considered upon submission of

adequate storage stability data in the

plant and livestock metabolism studies,

revised interference study,

developmental neurotoxicity study

(DNT) in the mouse, and an 8 day

inhalation study.

V. Conclusion

Therefore, the tolerance is established

for residues of mesotrione, 2-[4-

(methylsulfonyl)-2-nitrobenzoyl]-1,3-

cyclohexanedione, in or on the raw

agricultural commodities field corn

grain, field corn forage and field corn

stover at 0.01 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–301138 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 20, 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

33194 Federal Register / Vol. 66, No. 120 / Thursday, June 21, 2001 / Rules and Regulations

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–301138, 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 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).

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 record keeping

requirements.

Federal Register / Vol. 66, No. 120 / Thursday, June 21, 2001 / Rules and Regulations 33195

Dated: June 4, 2001.

Joseph Merenda,

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. Part 180 is amended by adding

§180.571 to read as follows:

§ 180.571 Mesotrione; tolerances for

residues.

(a) General. Tolerances are

established for residues of the herbicide

mesotrione, 2-[4-(methylsulfonyl)-2-

nitrobenzoyl]-1,3-cyclohexanedione, in

or on the following commodities:

Commodity Parts per

million

Corn, field, forage 0.01

Corn, field, grain 0.01

Corn, field, stover 0.01

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 01–15614 Filed 6–20–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301136; FRL–6785–6]

RIN 2070–AB78

L-Glutamic Acid and Gamma

Aminobutyric Acid; Exemptions from

the Requirement of a Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

exemptions from the requirement of a

tolerance for residues of L-glutamic acid

and gamma aminobutyric acid on all

food commodities when applied/used in

accordance with good agricultural

practices. Emerald BioAgriculture

Corporation submitted two petitions to

EPA under the Federal Food, Drug, and

Cosmetic Act, as amended by the Food

Quality Protection Act of 1996,

requesting exemptions from the

requirement of a tolerance. This

regulation eliminates the need to

establish a maximum permissible level

for residues of L-glutamic acid and

gamma aminobutyric acid.

DATES: This regulation is effective June

21, 2001. Objections and requests for

hearings, identified by docket control

number OPP–301136, must be received

by EPA on or before August 20, 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–301136 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Carol E. Frazer, c/o Product

Manager (PM) 90, Biopesticides and

Pollution Prevention Division (7511C),

Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: (703)

308–8810; and e-mail address:

frazer.carol@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer, or pesticide

manufacturer. Potentially affected

categories and entities may include, but

are not limited to:

Categories NAICS

codes

Examples of potentially affected entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations,’’ ‘‘Regulations

and Proposed Rules,’’ and then look up

the entry for this document under the

‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/. A frequently

updated electronic version of 40 CFR

part 180 is available at http://

www.access.gpo.gov/nara/cfr/

cfrhtml_00/Title_40/40cfr180._00.html,

a beta site currently under development.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–301136. 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 December 6,

2000 (65 FR 76241) (FRL–6748–9), EPA

issued a notice pursuant to section 408

of the Federal Food, Drug, and Cosmetic

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

amended by the Food Quality Protection

Act (FQPA) (Public Law 104–170)

announcing the filing of two pesticide

tolerance petitions by Emerald

BioAgriculture Corporation, 3125

Sovereign Drive, Suite B, Lansing, MI

48911–4240. This notice included a

summary of the petitions prepared by

the petitioner Emerald BioAgriculture

Corporation. There were no comments