Federal Register / Vol. 65, No. 129 / Wednesday, July 5, 2000 / Rules and Regulations 41355

The Clean Air Act forbids EPA to base

its actions concerning SIPs on such

grounds. Union Electric Co. v. U.S. EPA,

427 U.S. 246, 255–66 (1976); 42 U.S.C.

7410(a)(2).

F. Unfunded Mandates

Under sections 202 of the Unfunded

Mandates Reform Act of 1995

(‘‘Unfunded Mandates Act’’), signed

into law on March 22, 1995, EPA must

prepare a budgetary impact statement to

accompany any proposed or final rule

that includes a Federal mandate that

may result in estimated costs to State,

local, or tribal governments in the

aggregate; or to the private sector, of

$100 million or more. Under section

205, EPA must select the most costeffective and least burdensome

alternative that achieves the objectives

of the rule and is consistent with

statutory requirements. Section 203

requires EPA to establish a plan for

informing and advising any small

governments that may be significantly

or uniquely impacted by the rule.

EPA has determined that the approval

action promulgated does not include a

Federal mandate that may result in

estimated costs of $100 million or more

to either State, local, or tribal

governments in the aggregate, or to the

private sector. This Federal action

approves pre-existing requirements

under State or local law, and imposes

no new requirements. Accordingly, no

additional costs to State, local, or tribal

governments, or to the private sector,

result from this action.

G. 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. Section 804,

however, exempts from section 801 the

following types of rules: Rules of

particular applicability; rules relating to

agency management or personnel; and

rules of agency organization, procedure,

or practice that do not substantially

affect the rights or obligations of nonagency parties. 5 U.S.C. 804(3). EPA is

not required to submit a rule report

regarding this action under section 801

because this is a rule of particular

applicability.

H. National Technology Transfer and

Advancement Act

Section 12 of the National Technology

Transfer and Advancement Act

(NTTAA) of 1995 requires Federal

agencies to evaluate existing technical

standards when developing a new

regulation. To comply with NTTAA,

EPA must consider and use ‘‘voluntary

consensus standards’’ (VCS) if available

and applicable when developing

programs and policies unless doing so

would be inconsistent with applicable

law or otherwise impractical.

The EPA believes that VCS are

inapplicable to this action. Today’s

action does not require the public to

perform activities conducive to the use

of VCS.

I. Petitions for Judicial Review

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

Air Act, petitions for judicial review of

this action must be filed in the United

States Court of Appeals for the

appropriate circuit by September 5,

2000. Filing a petition for

reconsideration by the Administrator of

this final rule does not affect the finality

of this rule for the purposes of judicial

review nor does it extend the time

within which a petition for judicial

review may be filed, and shall not

postpone the effectiveness of such rule

or action. This action may not be

challenged later in proceedings to

enforce its requirements. (See section

307(b)(2).)

List of Subjects in 40 CFR Part 52

Environmental protection, Air

pollution control, Incorporation by

reference, Particulate matter.

Dated: May 31, 2000.

David A. Ullrich,

Acting Regional Administrator, Region 5.

For the reasons stated in the

preamble, part 52, chapter I, title 40 of

the Code of Federal Regulations is

amended as follows:

PART 52—[AMENDED]

1. The authority citation for part 52

continues to read as follows:

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

Subpart P—Indiana

2. Section 52.770 is amended by

adding paragraph (c)(135) to read as

follows:

§ 52.770 Identification of plan.

* * * * *

(c) * * *

(135) On January 1, 2000, Indiana

submitted revised opacity limits for

three processes at ALCOA Warrick

Operations. The revised limits allow

higher opacity emissions during fluxing

operations at three casting complexes.

This action does not change mass

emissions limits for these sources.

(i) Incorporation by reference.

(A) Modifications to Operating

Permits OP 87–07–91–0112 thru 0116:

Permit I.D. 173–10913, Issued on

October 1, 1999, to ALCOA, Inc.—

Warrick Operations. Effective October 1,

1999.

(B) Modifications to Operating Permit

OP 87–07–91–0113: Permit I.D. 173–

11414, Issued on December 15, 1999, to

ALCOA, Inc.—Warrick Operations.

Effective December 15, 1999.

[FR Doc. 00–16361 Filed 7–3–00; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300983; FRL–6496–5]

RIN 2070–AB78

Methoxyfenozide; Benzoic Acid, 3-

methoxy-2-methyl-2-(3,5-

dimethylbenzoyl)-2-(1,1-

dimethylethyl)hydrazide; Pesticide

Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: . This regulation establishes

tolerances for residues of

methoxyfenozide in or on cotton,

undelinted seed; cotton gin byproducts;

pome fruit; apple pomace, wet; milk,

meat of cattle, goats, hogs, horses and

sheep and fat of cattle, goats, hogs,

horses and sheep; and tolerances for the

combined residues of methoxyfenozide

and its glucuronide metabolite in meat

byproduct (except liver) and liver of

cattle, goats, hogs, horses and sheep.

Rohm and Haas Company requested

these tolerances under the Federal Food,

Drug, and Cosmetic Act (FFDCA), as

amended by the Food Quality Protection

Act (FQPA) of 1996.

DATES: This regulation is effective July

5, 2000. Objections and requests for

hearings, identified by docket control

number OPP–300983, must be received

by EPA on or before September 5, 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

41356 Federal Register / Vol. 65, No. 129 / Wednesday, July 5, 2000 / Rules and Regulations

docket control number OPP–300983 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Joseph Tavano, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, Ariel Rios Bldg., 1200

Pennsylvania Ave., NW.,Washington,

DC 20460; telephone number: (703)

305–6411; and e-mail address:

tavanojoseph@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’’ 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–300983. 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 (October 6,

1998, 63 FR 53656) (FRL–6033–8), EPA

issued a notice pursuant to section 408

of the FFDCA, 21 U.S.C. 346a as

amended by the FQPA of 1996 (Public

Law 104–170) announcing the filing of

a pesticide petition for tolerance by

Rohm and Haas Company, 100

Independence Mall West, Philadelphia,

PA 19106–2399. This notice included a

summary of the petition prepared by

Rohm and Haas Company, the

registrant. There were no comments

received in response to the notice of

filing.

The petition requested that 40 CFR

part 180 be amended by establishing

tolerances for residues of the

insecticide, methoxyfenozide, in or on

cottonseed; cotton gin trash; pome fruit;

meat, kidney, meat byproducts and milk

of cattle, goats, sheep and hogs and fat

of cattle, goats, sheep and hogs at 2.0,

25.0, 1.25, 0.02, 0.1 parts per million

(ppm) respectively and tolerances for

the combined residues of

methoxyfenozide and its glucuronide

metabolite in or on liver of cattle, goats,

sheep, and hogs at 0.1 ppm.

Methoxyfenozide is a reduced risk

pesticide which will be sold under the

trade name of Intrepid 2F.

Methoxyfenozide controls codling moth,

green fruitworm, lesser appleworm,

Oriental fruit moth, obliquebanded

leafroler, eyespotted bud moth, fruittree

leafroller, pandemis leafroller,

redbanded leafroller, variegated

leafroller, tufted apple bud moth,

spotted tentiform leafminer and Western

tentiform leafminer on pome fruit and

cotton bollworm, tobacco budworm,

beet armyworm, cabbage looper, cotton

leafworm, fall armyworm, Southern

armyworm, soybean looper and true

armyworm on cotton.

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

November 26, 1997 (62 FR 62961) (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 methoxyfenozide on cotton,

undelinted seed; cotton gin byproducts;

pome fruit; apple pomace, wet; milk;

meat of cattle, goats, hogs, horses, and

sheep and fat of cattle, goats, hogs,

horses, and sheep at 2.0, 35.0, 1.5, 7.0,

0.02, 0.02, 0.1 ppm respectively, and

tolerances for the combined residues of

methoxyfenozide and its glucuronide

metabolite in liver of cattle, goats, hogs,

horses and sheep and meat byproducts

(except liver) of cattle, goats, hogs,

horses and sheep at 0.1 and 0.02 ppm

respectively. EPA’s assessment of the

Federal Register / Vol. 65, No. 129 / Wednesday, July 5, 2000 / Rules and Regulations 41357

dietary 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 methoxyfenozide

are discussed in this unit.

Acute toxicity studies with technical

grade: Oral LD50 in the rat is > 5,000

milligrams/kilograms (mg/kg) for males

and females-Toxicity Category IV; Oral

LD50 in the mouse is > 5,000 mg/kg for

males and females-Toxicity Category IV;

Dermal LD50 in the rat is > 2,000 mg/kgToxicity Category III; Inhalation LC50 in

the rat is > 4.3 millgram/liter (mg/L)-

Toxicity Category IV; Primary Eye

Irritation in the rabbit -very mild

irritant-Toxicity Category IV; Primary

skin irritation in the rabbit-not a skin

irritant-Toxicity Category IV.

Methoxyfenozide is not a skin

sensitizer.

In an acute neurotoxicity study in

rats, statistically significant decreased

hindlimb grip strength was observed in

male rats at 3 hours (approximate time

of peak effect) following a single oral

dose of 2,000 mg/kg (limit dose) of

methoxyfenozide. Decreased hindlimb

grip strength was also observed in the

male rats at 7 and 14 days, but was not

statistically significant. No other

systemic or neurotoxic effects were

observed in the male rats or in the

female rats at any time in this study.

Since this marginal effect occurred only

in one sex, was statistically significant

at only one time, was observed only at

the high dose (limit dose) and no other

signs of toxicity were observed in the

rats in this study, this possible effect is

not considered to be biologically

significant. In addition, neither

decreased hindlimb grip strength nor

any other signs of neurotoxicity were

observed in any of the animals at any

time in a 90-day subchronic

neurotoxicity study in rats.

In a 2-week range-finding dietary

study in rats, treatment-related effects

were observed at > 5,000 ppm in the

liver (increased liver weights and

hepatocellular hypertrophy in males

and females), in the thyroid gland

(hypertrophy/hyperplasia of follicular

cells in males and females), and in the

adrenal gland (increased adrenal

weights and/or hypertrophy of the zona

fasciculata in females). Hypertrophy/

hyperplasia of thyroid follicular cells

was also observed in males and females

at 1,000 ppm, the lowest observed

adverse effect level (LOAEL) in this

study. The no observed adverse effect

level (NOAEL) was 250 ppm.

Treatment-related hematological

changes were not observed in the rats in

this study.

In a 3-month feeding study in rats, the

predominant treatment-related effects

were increased liver weights in males

and females and periportal

hepatocellular hypertrophy in all males

and females at 20,000 ppm highest dose

tested (HDT) and at 5,000 ppm. In

addition, at 20,000 ppm, a slightly

decreased (7-8%) RBC count and

slightly decreased (7-8%) hemoglobin

concentration, compared to control rats,

were observed in the females. The

LOAEL in this study was 5,000 ppm

(353/379 mg/kg/day in males/females,

respectively). The NOAEL was 1,000

ppm (69/72 mg/kg/day in males/

females, respectively). Although

observed in the 2-week dietary study

and in the 2-year chronic feeding/

carcinogenicity study in rats, treatmentrelated effects in the thyroid and

adrenal glands were not observed in the

rats in this 3-month study. There is no

available biological explanation for this

difference in findings in the studies.

In a 2-year combined chronic feeding/

carcinogenicity study in rats, the

following treatment-related effects were

observed at 20,000 ppm (highest dose

tested): decreased survival in males,

decreased body weight and food

efficiency in females during the last year

of the study, hematological changes

(decreased RBC counts, hemoglobin

concentrations, and/or hematocrits;

methemoglobinemia; and increased

platelet counts) in males and females,

increased liver weights and periportal

hepatocellular hypertrophy in males

and females, thyroid follicular cell

hypertrophy in males, altered thyroid

colloid in males and females, and

increased adrenal weights in males and

females. At 8,000 ppm, the following

treatment-related effects were observed:

hematological changes (decreased RBC

counts, hemoglobin concentrations,

and/or hematocrits in males and

females), liver toxicity (increased liver

weights in males and periportal

hepatocellular hypertrophy in males

and females), histopathological changes

in the thyroid (increased follicular cell

hypertrophy in males and altered

colloid in males) and possible adrenal

toxicity (increased adrenal weights in

males and females). The LOAEL in this

study was 8,000 ppm (411/491 mg/kg/

day in males/females, respectively),

based on the effects described above.

The NOAEL was 200 ppm (10.2/11.9

mg/kg/day in males/females,

respectively). This NOAEL was used to

establish the reference dose (RfD) for

methoxyfenozide. Utilizing an

uncertainty factor of 100 to account for

both interspecies extrapolation (10x)

and intraspecies variability (10x), the

chronic RfD for methoxyfenozide was

calculated to be 0.10 mg/kg/day. No

evidence of carcinogenicity was

observed in this study. Dosing was

considered adequate because of the

decreased survival in males and the

decreased body weights and food

efficiency in females at 20,000 ppm. In

addition, the HDT for both males and

females, 20,000 ppm (1,045/1,248 mg/

kg/day in males/females, respectively),

is higher than the limit dose of 1,000

mg/kg/day.

In a 2-week range-finding study in

dogs, treatment-related hematological

changes were observed in both males

and females at 3,500 ppm, 7,000 ppm,

15,000 ppm, and 30,000 ppm (HDT).

These changes included decreased RBC

counts, decreased hemoglobin

concentrations, decreased hematocrits,

decreased MCHC, increased MCV,

increased MCH, increased Heinz bodies,

methemoglobinemia, changes in RBC

morphology such as Howell-Jolly bodies

and polychromasia, increased

reticulocyte counts, increased nucleated

RBC and increased platelet counts. At

the same dose levels (> 3,500 ppm),

increased spleen weights and/or

enlarged spleens were also observed. At

7,000 ppm, plasma total bilirubin was

increased. The LOAEL in this study was

3,500 ppm (90-184 mg/kg/day in males

and females). The NOAEL was 300 ppm

(11–16 mg/kg/day in males and

females).

In a 3-month feeding study in dogs,

no treatment-related effects other than a

suggestion of decreased body weight

gains in males and females were

observed in either males or females at

the HDT viz. 5,000 ppm (198/209 mg/

kg/day in males/females, respectively).

Although hematological effects were

noted in dogs in the 2-week rangefinding study at > 3,500 ppm (90-184

mg/kg/day) and in the 1-year chronic

feeding study at > 3,000 ppm (106/111

mg/kg/day), hematological changes were

not observed in this 3-month study at

5,000 ppm (198/209 mg/kg/day). There

is no available biological explanation for

this difference in findings in the studies.

As part of the 3-month study in dogs,

some male and female dogs were given

15 ppm (0.6 mg/kg/day) of

methoxyfenozide in the diet for 15

weeks followed by an increase in the

dietary dose to 15,000 ppm (422/460

mg/kg/day in males/females,

41358 Federal Register / Vol. 65, No. 129 / Wednesday, July 5, 2000 / Rules and Regulations

respectively) for an additional 6 weeks.

After about 2 weeks and 6 weeks at

15,000 ppm, hematological

examinations were conducted. No

hematological changes in these dogs

were observed. Apparently,

pretreatment of the dogs at 15 ppm for

15 weeks prevented the occurrence of

hematological changes which would

have been expected to occur based on

results in the 2-week and 1-year feeding

studies. One possible explanation is that

the liver microsomal enzyme system

may have been stimulated so much

during pretreatment at 15 ppm that the

metabolic (detoxification) rate of

methoxyfenozide was increased to the

point where blood levels of

methoxyfenozide may have remained

below critical effect levels at 15,000

ppm. Another possible explanation is

that compensatory mechanisms for

replacing damaged RBC in pretreated

dogs may have been so efficient that

hematological changes were not

observed in these dogs even at 15,000

ppm. Other explanations for this finding

are also possible.

In a 1-year chronic feeding study in

dogs, the predominant toxic effects were

anemia and signs of an associated

compensatory response. At 30,000 ppm,

the HDT, the following treatmentrelated effects were observed in both

males and females: decreased RBC

counts, decreased hemoglobin

concentrations, decreased hematocrits,

methemoglobinemia, nucleated RBC,

increased platelets, increased serum

total bilirubin, bilirubinurea, increased

hemosiderin in macrophages in liver

and spleen, and increased hyperplasia

in bone marrow of rib and sternum.

Increased liver weights in males and

females and increased thyroid weights

in males were also observed at 30,000

ppm. Signs of anemia were also noted

at 3,000 ppm and included decreased

RBC counts, decreased hemoglobin

concentrations, decreased hematocrits,

methemoglobinemia, increased

platelets, and increased serum total

bilirubin and bilirubinurea. The LOAEL

in this study was 3,000 ppm (106/111

mg/kg/day in males/females,

respectively). The NOAEL was 300 ppm

(9.8/12.6 mg/kg/day in males/females,

respectively).

In a 3-month feeding study in mice,

the only treatment-related effect was

decreased body weight gain in males

and females at 7,000 ppm, the HDT. The

LOAEL in this study was 7,000 ppm

(1,149/1,742 mg/kg/day in males/

females, respectively) and the NOAEL

was 2,500 ppm (428/589 mg/kg/day in

males/females, respectively). In an 18-

month carcinogenicity study in mice

(MRID 44617729), no treatment-related

effects were observed at doses up to and

including the limit dose of 7,000 ppm

(1,020/1,354 mg/kg/day in males/

females, respectively). No evidence of

carcinogenicity was observed in this

study. Dosing was considered adequate

because the HDT for both males and

females, 7,000 ppm (1,020/1,354 mg/kg/

day in males/females, respectively), is

higher than the limit dose of 1,000 mg/

kg/day.

In a battery of four mutagenicity

studies (with and without metabolic

activation, as appropriate for the

specific study), technical grade

methoxyfenozide was negative for

genotoxicity in all four studies. The four

studies satisfy the new revised

mutagenicity guideline requirements for

a new chemical (published in 1991). An

additional mutagenicity study,

performed on RH–117,236 (Metabolite

M-B), a metabolite of methoxyfenozide,

was also negative for genotoxicity.

Based on the lack of evidence of

carcinogenicity in male and female rats

as well as in male and female mice and

on the lack of genotoxicity in an

acceptable battery of mutagenicity

studies, methoxyfenozide is classified as

a ‘‘not likely’’ human carcinogen

according to the EPA.

In a developmental toxicity study in

rats, no signs of maternal toxicity in

dams or of developmental toxicity in

fetuses were observed at the limit dose

of 1,000 mg/kg/day. The NOAEL in this

study for both maternal toxicity and

developmental toxicity was 1,000 mg/

kg/day. The LOAEL was > 1,000 mg/kg/

day. Similarly, in a developmental

toxicity study in rabbits, no signs of

maternal toxicity or of developmental

toxicity were observed at the limit dose

of 1,000 mg/kg/day. The NOAEL in this

study for both maternal toxicity and

developmental toxicity was 1,000 mg/

kg/day. The LOAEL was > 1,000 mg/kg/

day.

In neither the developmental toxicity

study in rats nor in the developmental

toxicity study in rabbits was there any

evidence for increased susceptibility of

fetuses to in utero exposure to

methoxyfenozide. In these studies,

methoxyfenozide was determined not to

be a developmental toxicant.

In a 2-generation (1 litter/generation)

reproduction study in rats, treatmentrelated parental toxicity was observed

only at 20,000 ppm, the HDT. At this

dose, increased liver weights were

observed in males and females of both

generations and midzonal to periportal

hepatocellular hypertrophy was

observed in the livers of all males and

females of both generations. The LOAEL

for parental toxicity was 20,000 ppm

(1,552/1,821 mg/kg/day for males/

females, respectively) and the NOAEL

was 2,000 ppm (153/181 mg/kg/day for

males/females, respectively). There

were no treatment-related effects on

reproductive parameters for adult

(parent) animals. The NOAEL for

reproductive toxicity was 20,000 ppm.

Since no treatment-related effects were

observed in the pups, the NOAEL for

neonatal toxicity was also, 20,000 ppm.

The NOAEL for parental toxicity in this

reproduction study is higher than the

NOAEL for the 2-year combined chronic

feeding/carcinogenicity study in rats

because many of the toxic effects

observed in the 2-year study at the

LOAEL (hematological changes, liver

toxicity, histopathological changes in

the thyroid gland and increased adrenal

weights) were not examined in the

reproduction study.

In a metabolism study in rats, 14Cmethoxyfenozide was rapidly absorbed,

distributed, metabolized and almost

completely excreted within 48 hours.

The major route of excretion was feces

(86–97%) with lesser amounts in the

urine (5–13%). An enterohepatic

circulation was observed. The test

material was metabolized principally by

O-demethylation of the A-ring methoxy

group and oxidative hydroxylation of

the B-ring methyl groups followed by

conjugation with glucuronic acid. No

significant sex-related or dosedependent differences in metabolic

disposition were noted. Seven

metabolites and the parent accounted

for 74–90% of the administered dose in

all groups. The glucuronide conjugates

are considered to be less toxic than the

parent compound because glucuronide

conjugation is well known to be a

commonly occurring ‘‘detoxification’’

mechanism in mammalian species since

it results in the formation of more polar,

more water-soluble metabolites which

are readily and easily excreted from the

body (in this case, in the bile and urine).

Further, based on similarities of

chemical structure, the non-conjugated

metabolites would be expected to be no

more toxic than the parent compound.

In a dermal absorption study in rats

using an 80% wettable powder

formulation as the test material, the

cumulative dermal absorption of test

material after a 10- or 24-hour dermal

exposure was determined to be 2%. In

a 28-day dermal toxicity study in rats,

no treatment-related systemic or skin

effects were observed at the limit dose

of 1,000 mg/kg/day (HDT). Regarding

effects on endocrine organs,

methoxyfenozide affected the thyroid

gland and adrenal gland in the 2-week

and 2-year feeding studies in rats. In the

thyroid gland, hypertrophy/hyperplasia

Federal Register / Vol. 65, No. 129 / Wednesday, July 5, 2000 / Rules and Regulations 41359

of follicular cells and altered colloid

were observed in males and females at

or near the LOAEL in both of these

studies. In the adrenal gland, increased

adrenal weights and hypertrophy of the

zona fasciculata were also observed in

males and females at or near the

LOAEL. In addition, in the 1-year

chronic feeding study in dogs, increased

thyroid weight in males was observed,

but only at the very high dose of 30,000

ppm. Since the definition and

regulatory significance of the term

‘‘endocrine disruptor chemical’’ has not

yet been established by the Agency, it is

not clear whether methoxyfenozide, on

the basis of these effects on the thyroid

gland and adrenal gland, should be

considered to be an ‘‘endocrine

disruptor chemical.’’ Other than the

morphological changes described above,

there were no signs of thyroid or adrenal

dysfunction in these or in any other

studies on methoxyfenozide.

B. Toxicological Endpoints

1. Acute toxicity. No appropriate

toxicological endpoint attributable to a

single exposure was identified in the

available toxicology studies on

methoxyfenozide including the acute

neurotoxicity study in rats, the

developmental toxicity study in rats and

the developmental toxicity study in

rabbits. In the acute neurotoxicity study

in rats, statistically significant decreased

hindlimb grip strength was observed in

male rats at 3 hours (approximate time

of peak effect) following a single oral

dose of 2,000 mg/kg (limit dose) of

methoxyfenozide. Decreased hindlimb

grip strength was also observed in the

male rats at 2,000 mg/kg at 7 and 14

days, but was not statistically

significant. Decreased hindlimb grip

strength was not observed in the male

rats at 1,000 mg/kg. No other systemic

or neurotoxic effects were observed in

the male rats or in the female rats at any

time in the study. Since this marginal

effect occurred only in one sex, was

statistically significant only one time,

was observed only at the high dose

(limit dose) and no other signs of

toxicity were observed in the rats in the

study, this equivocal effect is not

considered to be an appropriate

toxicological endpoint for acute dietary

risk assessments. In addition, decreased

hindlimb grip strength was not observed

in a subchronic neurotoxicity study in

rats in any of the animals at any time.

It is also noted that the acute oral LD50

for male and female rats for technical

grade methoxyfenozide (98% active

ingredient (a.i.) is > 5,000 mg/kg

(Toxicity Category IV). No treatmentrelated effects were observed in either

dams or pups in the developmental

toxicity studies in rats or rabbits at

doses up to the limit dose of 1,000 mg/

kg/day. Thus the risk from acute

exposure is considered negligible.

2. Short- and intermediate-term

toxicity. In a 28-day repeated dose

dermal toxicity study in rats, no

systemic or dermal toxicity was

observed at 1,000 mg/kg/day, the HDT

(limit dose). By applying the dermal

absorption factor of 2% (derived from a

dermal absorption study in rats, to the

NOAEL of 10.2 mg/kg/day and the

LOAEL of 411 mg/kg/day in the 2-year

combined chronic feeding/

carcinogenicity study in rats, the oral

NOAEL and LOAEL in this study are

equivalent to a dermal NOAEL of 510

mg/kg/day and a dermal LOAEL of

20,550 mg/kg/day. By applying the

dermal absorption factor of 2% to the

NOAEL of 9.8 mg/kg/day and the

LOAEL of 106.1 mg/kg/day in the 1-year

chronic feeding study in dogs, the oral

NOAEL and LOAEL in this study are

equivalent to a dermal NOAEL of 490

mg/kg/day and a dermal LOAEL of

5,305 mg/kg/day. The likelihood of

toxic effects resulting from repeated

dermal exposure to methoxyfenozide is

quite low. Further, based on the use

pattern, no long-term dermal exposure

is expected to occur.

Methoxyfenozide is a non-volatile

solid with a very low vapor pressure of

> 1 x 10-7 torr (or > 1.33 x 10-5 pascal).

In an acute inhalation toxicity study in

rats, the acute inhalation LC50 for

technical grade methoxyfenozide dust

(98% a.i.) was determined to be > 4.3

mg/L (> 2x limit dose, Toxicity Category

IV) for both male and female rats. In

another acute inhalation toxicity study

in rats), the acute inhalation LC50 for

RH–112,485 80WP formulation 80% a.i.

was determined to be > 4.5 mg/L (> 2x

limit dose, Toxicity Category IV) for

both male and female rats. In both of

these acute inhalation toxicity studies,

there were no mortalities, treatmentrelated clinical signs, changes in body

weights or necropsy findings. Based on

the low vapor pressure, the low acute

inhalation toxicity (Toxicity Category

IV) of the technical grade product and

the formulated product, the packaging

of the formulated product (water soluble

pouches), the application rate (0.05 to

0.4 lb. a.i./acre for a maximum of 2.0 lb.

ai/season), and the application method,

there is minimal concern for potential

inhalation risk. Further, based on the

use pattern, no long-term inhalation

exposure is expected to occur.

3. Chronic toxicity. EPA has

established the RfD for methoxyfenozide

at 0.10 mg/kg/day. This RfD is based on

a NOAEL of 10.2 mg/kg/day and an UF

of 100 accounting for both interspecies

extrapolation (10x) and intraspecies

variability (10x). This chronic RfD is

based on the 2-year combined chronic

feeding/carcinogenicity study in rats, in

which the following effects were

observed at the LOAEL of 411/491 mg/

kg/day in males/females: hematological

changes (decreased RBC counts,

hemoglobin concentrations, and/or

hematocrit in males and females), liver

toxicity (increased liver weights in

males and periportal hepatocellular

hypertrophy in males and females),

histopathological changes in the thyroid

(increased follicular cell hypertrophy

and altered colloid in males) and

possible adrenal toxicity (increased

adrenal weights in males and females).

EPA determined that the 10x Safety

Facter for the protection of infants and

children (as required by FQPA) should

be reduced to 1x. Therefore, the chronic

Population Adjusted Dose (cPAD) is the

same as the RFD. This cPAD is used in

assessing chronic risk and applies to all

population subgroups. Reducing the 10x

safety factor to 1x is supported by the

following factors:

i. The toxicology data base for

methoxyfenozide is complete for

assessment of potential hazard to infants

and children.

ii. Based on weight-of-the-evidence

considerations, EPA determined that a

developmental neurotoxicity study in

rats is not required to support the

registration of methoxyfenozide.

iii. In developmental toxicity studies

in rats and rabbits, no increased

susceptibility in fetuses as compared to

maternal animals was observed

following in utero exposures.

iv. In a 2-generation reproduction

study in rats, no increased susceptibility

in pups as compared to adults was

observed following in utero and

postnatal exposures.

v. The exposure assessments will not

underestimate the potential dietary

(food and drinking water) or non-dietary

exposures for infants and children from

the use of methoxyfenozide.

4. Carcinogenicity. Methoxyfenozide

has been classified as a ‘‘not likely’’

human carcinogen. This classification is

based on the lack of evidence of

carcinogenicity in male and female rats

as well as in male and female mice and

on the lack of genotoxicity in an

acceptable battery of mutagenicity

studies.

C. Exposures and Risks

1. From food and feed uses. In today’s

action tolerances will be established (40

CFR part 180) for the residues of

methoxyfenozide on cotton, undelinted

seed; cotton gin byproducts; pome fruit;

apple pomace, wet; milk; meat of cattle,

41360 Federal Register / Vol. 65, No. 129 / Wednesday, July 5, 2000 / Rules and Regulations

goats, hogs, horses and sheep and fat of

cattle, goats, hogs, horses and sheep at

2.0, 35.0, 1.5, 7.0, 0.02, 0.02, 0.1 ppm

and tolerances for the combined

residues of methoxyfenozide and its

glucuronide metabolite in liver of cattle,

goats, hogs, horses and sheep and meat

byproducts (except liver) of cattle, goats,

hogs, horses and sheep at 0.1 and 0.02

ppm respectively. Risk assessments

were conducted by EPA to assess

dietary exposures from

methoxyfenozide as follows.

i. Acute exposure and risk. Acute

dietary risk assessments are performed

for a food-use pesticide if a toxicological

study has indicated the possibility of an

effect of concern occurring as a result of

a 1-day or single exposure. No

appropriate toxicological endpoint

attributable to a single exposure was

identified in the available toxicology

studies on methoxyfenozide including

the acute neurotoxicity study in rats, the

developmental toxicity study in rats and

the developmental toxicity study in

rabbits. This risk is considered to be

negligible.

ii. Chronic exposure and risk. EPA

used the Dietary Exposure Evaluation

Model (DEEM ) software for conducting

a chronic dietary (food) risk analysis.

DEEM is a dietary exposure analysis

system that is used to estimate exposure

to a pesticide chemical in foods

comprising the diets of the U.S.

population, including population

subgroups. DEEM contains food

consumption data as reported by

respondents in the USDA Continuing

Surveys of Food Intake by Individuals

conducted in 1989-1992. EPA has made

the assumptions that 100% of pome

fruit and cotton would be treated and

contain methoxyfenozide residues at the

tolerance level. The following tolerance

levels were used in the analysis:

Commodity

Tolerance Level

(parts per million)

(ppm)

Cotton, underlinted

seed.

2.0 ppm

Pome fruits ................ 1.5 ppm

Milk ............................ 0.02 ppm

Meat* ......................... 0.02 ppm

Meat byproducts* (except liver).0.02 ppm

Fat* ............................ 0.1 ppm

Liver .......................... 0.1 ppm

*of cattle, goats, hogs, horses and sheep.

Processing factors were also applied

to apple juice concentrate (3x), dried

apples (8x), dried beef (1.92x), dried

pears (6.25x), and dried veal (1.92x).

The processing factors are default values

from DEEM.

As shown in the following table, the

resulting dietary food exposures occupy

up to 11% of the Chronic PAD for the

most highly exposed population

subgroup, non-nursing infants. These

results should be viewed as

conservative (health protective) risk

estimates. Refinements such as use of

percent crop-treated information and/or

anticipated residue values would yield

even lower estimates of chronic dietary

exposure.

SUMMARY: CHRONIC DIETARY EXPOSURE ANALYSIS BY DEEM (TIER 1)

Population Subgroup1Exposure

(mg/kg/day)

% of Chronic PAD2

U.S. population

(total).

0.001839 1.8

All infants (> 1

year).

0.009617 9.6

Nursing infants .. 0.005605 5.6

Non-nursing infants.0.011306 11

Children (1–6

years).

0.007350 6.8

Children (7–12

years).

0.003103 2.8

U.S. population

(autumn season).

0.002285 2.3

U.S. population

(winter season).

0.001891 1.9

Northeast region 0.002014 2.0

Western region 0.002004 2.0

Non-hispanic

whites.

0.001917 1.9

Non-hispanic/

non-white/nonblack.

0.002025 2.0

Females (> 13

years, nursing).

0.002479 2.5

Pacific region .... 0.002023 2.0

1 The subgroups listed are: (1) The U.S.

population (total); (2) those for infants and

children; (3) the other subgroup(s), if any, for

which the percentage of the Chronic PAD occupied is greater than that occupied by the

subgroup U.S. population (total); and, (4) the

most highly exposed of the females subgroups

(in this case, females, > 13 years, nursing). 2 Percent chronic PAD = (Exposure ÷

Chronic PAD) x 100%.

2. From drinking water. The Agency

currently lacks sufficient water-related

exposure data from monitoring to

complete a quantitative drinking water

exposure analysis and risk assessment

for methoxyfenozide. Therefore, the

Agency is presently relying on

computer-generated estimated

environmental concentrations (EECs).

GENEEC and/or PRZM/EXAMS (both

produce estimates of pesticide

concentration in a farm pond) are used

to generate EECs for surface water and

SCI-GROW (an empirical model based

upon actual monitoring data collected

for a number of pesticides that serve as

benchmarks) predicts EECs in ground

water. These models take into account

the use patterns and the environmental

profile of a pesticide, but do not include

consideration of the impact that

processing 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 assessing whether a

pesticide is likely to be present in

drinking water at concentrations which

would exceed human health levels of

concern.

A drinking water level of comparison

(DWLOC) is the concentration of a

pesticide in drinking water that would

be acceptable as a theoretical upper

limit in light of total aggregate exposure

to that pesticide from food, water, and

residential uses. HED uses DWLOCs

internally in the risk assessment process

as a surrogate measure of potential

exposure associated with pesticide

exposure through drinking water. In the

absence of monitoring data for a

pesticide, the DWLOC is used as a point

of comparison against the conservative

EECs provided by computer modeling

(SCI-GROW, GENEEC, PRZM/EXAMS).

i. Acute exposure and risk. Because

no acute dietary endpoint was

determined, the Agency concludes that

there is a reasonable certainty of no

harm from acute exposure from drinking

water.

ii. Chronic exposure and risk. EPA

conducted its Tier II screening-level

assessments using the simulation

models SCI-GROW and PRZM/EXAMS

to generate EECs for ground and surface

water, respectively. The modeling was

conducted based on the environmental

profile and the maximum seasonal

application rate proposed for

methoxyfenozide (0.4 lb ai/acre x 5

applications/acre/year on cotton).

PRZM/EXAMS was used to generate the

surface water EECs, because it can factor

the persistent nature of the chemical

into the estimates.

The EECs for assessing chronic

aggregate dietary risk are 312 parts per

billion (ppb) (in ground water, based on

SCI-GROW) and 3,197 ppb (in surface

water, based on the PRZM/EXAMS,

long-term mean). The back-calculated

DWLOCs for assessing chronic aggregate

dietary risk range from 890 ppb for the

most highly exposed population

subgroup (Non-nursing infants, > 1-year

old) to 3,400 ppb for the U.S. population

(48 contiguous States—all seasons) and

the U.S. population (autumn season).

The SCI-GROW and PRZM/EXAMS

chronic EECs are less than the Agency’s

Federal Register / Vol. 65, No. 129 / Wednesday, July 5, 2000 / Rules and Regulations 41361

level of comparison (the DWLOC value

for each population subgroup) for

methoxyfenozide residues in drinking

water as a contribution to chronic

aggregate exposure. EPA thus concludes

with reasonable certainty that residues

of methoxyfenozide in drinking water

will not contribute significantly to the

aggregate chronic human health risk and

that the chronic aggregate exposure from

methoxyfenozide residues in food and

drinking water will not exceed the

Agency’s level of concern (100% of the

cPAD) for chronic dietary aggregate

exposure by any population subgroup.

EPA generally has no concern for

exposures below 100% of the cPAD,

because it is a level at or below which

daily aggregate dietary exposure over a

lifetime will not pose appreciable risks

to the health and safety of any

population subgroup. This risk

assessment is considered high

confidence, conservative, and very

protective of human health.

3. From non-dietary exposure.

Methoxyfenozide is not currently

registered for use on any residential

non-food sites. Therefore, there is no

non-dietary acute, chronic, short- or

intermediate-term 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

methoxyfenozide 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,

methoxyfenozide 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 methoxyfenozide 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

November 26, 1997 (62 FR 62961)

(5754–7).

D. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. Since no acute

toxicological endpoints were

established, EPA considers acute

aggregate risk to be negligible.

2. Chronic risk. Using the DEEM

exposure assumptions described in this

unit, EPA has concluded that aggregate

exposure to methoxyfenozide from food

will utilize 1.8% of the cPAD for the

U.S. population. The major identifiable

subgroup with the highest aggregate

exposure is non-nursing infants (> 1-

year old) at 11% of the cPAD and is

discussed below. EPA generally has no

concern for exposures below 100% of

the cPAD because the cPAD represents

the level at or below which daily

aggregate dietary exposure over a

lifetime will not pose appreciable risks

to human health. Despite the potential

for exposure to methoxyfenozide in

drinking water, EPA does not expect the

aggregate exposure to exceed 100% of

the cPAD. EPA concludes that there is

a reasonable certainty that no harm will

result from aggregate exposure to

methoxyfenozide residues.

3. Short- and intermediate-term risk.

Short- and intermediate-term aggregate

exposure takes into account chronic

dietary food and water (considered to be

a background exposure level) plus

indoor and outdoor residential

exposure.

Since there are currently no registered

indoor or outdoor residential nondietary uses of methoxyfenozide and no

short or intermediate term toxic

endpoints, EPA considers short or

intermediate term aggregate risks to be

negligible.

4. Aggregate cancer risk for U.S.

population. Methoxyfenozide is

classified as a ‘‘not likely’’ human

carcinogen. Therefore this risk does is

negligible.

5. Determination of safety. Based on

these risk assessments, EPA concludes

that there is a reasonable certainty that

no harm will result from aggregate

exposure to methoxyfenozide residues.

E. Aggregate Risks and Determination of

Safety for Infants and Children

1. Safety factor for infants and

children—In general. In assessing the

potential for additional sensitivity of

infants and children to residues of

methoxyfenozide, EPA considered data

from developmental toxicity studies in

the rat and rabbit and a 2-generation

reproduction study in the rat. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

maternal pesticide exposure during

gestation. Reproduction studies provide

information relating to effects from

exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

FFDCA section 408 provides that EPA

shall apply an additional tenfold margin

of safety for infants and children in the

case of threshold effects to account for

prenatal and postnatal toxicity and the

completeness of the data base 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. EPA

believes that reliable data support using

the standard uncertainty factor (usually

100 for combined interspecies and

intraspecies variability) and not the

additional tenfold MOE/UF when EPA

has a complete data base under existing

guidelines and when the severity of the

effect in infants or children or the

potency or unusual toxic properties of a

compound do not raise concerns

regarding the adequacy of the standard

MOE/safety factor.

2. Prenatal and postnatal sensitivity.

The toxicology data base for

methoxyfenozide included acceptable

developmental toxicity studies in both

rats and rabbits as well as a 2-generation

reproductive toxicity study in rats.The

data provided no indication of increased

sensitivity of rats or rabbits to in utero

and/or postnatal exposure to

methoxyfenozide.

3. Conclusion. There is a complete

toxicity data base for methoxyfenozide

and exposure data are complete or are

estimated based on data that reasonably

accounts for potential exposures. Based

on the completeness of the data base

and the lack of prenatal and postnatal

toxicity, EPA determined that an

additional safety factor was not needed

for the protection of infants and

children.

4. Acute risk. Since no acute

toxicological endpoints were

established, EPA considers acute

aggregate risk to be negligible.

5. Chronic risk. Using the exposure

assumptions described in this unit, EPA

has concluded that aggregate exposure

to methoxyfenozide from food will

utilize 11% of the cPAD for infants and

children. EPA generally has no concern

for exposures below 100% of the cPAD

because the cPAD represents the level at

or below which daily aggregate dietary

exposure over a lifetime will not pose

appreciable risks to human health.

Despite the potential for exposure to

41362 Federal Register / Vol. 65, No. 129 / Wednesday, July 5, 2000 / Rules and Regulations

methoxyfenozide in drinking water,

EPA does not expect the aggregate

exposure to exceed 100% of the cPAD.

6. Short- or intermediate-term risk.

Short and intermediate term risks are

judged to be negligible due to the lack

of significant toxicological effects

observed.

7. Determination of safety. Based on

these risk assessments, EPA concludes

that there is a reasonable certainty that

no harm will result to infants and

children from aggregate exposure to

methoxyfenozide residues.

IV. Other Considerations

A. Metabolism in Plants and Animals

The qualitative nature of

methoxyfenozide residues in plants is

adequately understood based upon

acceptable cotton, apple and grape

metabolism studies. EPA has

determined that the residue of concern

for dietary exposure and tolerance

setting purposes in primary crops and

water is the parent compound,

methoxyfenozide.

The qualitative nature of the residue

in animals is adequately understood

based on acceptable studies conducted

on goats and laying hens. EPA has

determined that the residue of concern

in milk and ruminant tissues (other than

liver and kidney) is the parent

compound, methoxyfenozide. The

residue of concern in ruminant liver and

kidney is the parent compound,

methoxyfenozide, and its glucuronide

metabolite designated as RH–141,518

(also referred to as RH–1518). The

glucuronide metabolite was included in

the tolerance expression for liver and

kidney because the conjugation may be

reversible and it comprises a significant

portion of the total radioactive residues

(TRR) (up to 42% TRR in kidney and up

to 29% TRR in liver) in those tissues.

B. Analytical Enforcement Methodology

The petitioner has proposed HPLC/

UV Method TR 34–98–87 for the

enforcement of tolerances for pome

fruits. Adequate confirmatory method

validation, radiovalidation, and

independent method validation data

have been submitted for this method.

This method was sent to the EPA

laboratory for a petition method

validation (PMV). The laboratory has

reported that the pome fruit method

(Method TR 34–98–87) is adequate in

the interim for enforcement of the

proposed tolerances for

methoxyfenozide in/on pome fruit.

Initial recoveries (60%) in the PMV

were just below the minium acceptable

recovery level (70%) as specified in

OPPTS Harmonized Test Guidelines

860.1340. The laboratory modified the

method and achieved acceptable

recoveries with the modified method.

EPA will require that Rohm and Haas

Company revise and modify the

method. Additional recovery data will

be required for the revised method.

The petitioner has proposed Method

TR 43–96–88 for the enforcement of

tolerances for cotton. This method is a

shortened version of the pome fruit

method. Thus, EPA concludes that

Method TR 34–96–87 is adequate for

enforcement of the proposed tolerances

for residues of methoxyfenozide in/on

cotton commodities. The validation of

the cotton method is in progress. EPA

expects that Method TR 43–96–88 will

need to be modified or revised and

additional recovery data may be

required. EPA will require Rohm and

Haas Company to revise and modify the

cotton method and submit any

additional recovery data if necessary.

The petitioner has proposed Method

TR 34–98–106 for the enforcement of

tolerances in animal commodities. This

method determines residues of

methoxyfenozide (HPLC/UV) in fat,

cream, milk, and muscle and residues of

methoxyfenozide and its glucuronide

metabolite, RH–141,518 (HPLC/MS) in

liver and kidney. Adequate

confirmatory method validation,

radiovalidation, and independent

method validation data, have been

submitted for this method. This method

has been forwarded to the EPA

laboratory for petition method

validation (PMV). The method has

passed the PMV, however it requires

some minor revisions. EPA will require

that Rohm and Haas Company revise the

method and resubmit the final revised

method.

The petitioner submitted data

concerning the recovery of residues of

methoxyfenozide using Food and Drug

Administration (FDA) multiresidue

method protocols (PAM Vol. I).

Methoxyfenozide was not recoverable

by these methods. These data will be

forwarded to FDA for evaluation.

EPA has determined that the residues

of concern in ruminant liver and kidney

are methoxyfenozide and its metabolite

RH–141,518. Data concerning the

recovery of residues of RH–141,518

using FDA multiresidue method

protocols (PAM Vol. I) will be required.

This will be made a condition of the

registration for methoxyfenozide.

Adequate enforcement methodology

is available to enforce the tolerance

expression. The methods may be

requested from: Calvin Furlow, PRRIB,

IRSD (7502C), Office of Pesticide

Programs, Environmental Protection

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

DC 20460; telephone number: (703)

305–5229; e-mail address:

furlow.calvin@epa.gov.

C. Magnitude of Residues

1. Magnitude of the residue in apples

and pears. An adequate number of

geographically representative field trials

were submitted to support the proposed

use on pome fruits. Apples and pears

are the representative commodities of

this crop group. These studies were

conducted via use patterns

approximating those proposed by this

petition. Residues of methoxyfenozide

ranged from 0.16 to 1.2 ppm in/on

apples and from 0.21 to 0.93 ppm in/on

pears treated with the 80% WP

formulation according to the maximum

proposed use patterns. The results of the

field trials indicate that residues of

methoxyfenozide will not exceed 1.5

ppm in/on pome fruit when treated as

proposed. Rohm and Haas Company

proposed a tolerance level of 1.25 ppm

for residues of methoxyfenozide in/on

pome fruit. EPA concludes that the

proposed tolerance must be raised to 1.5

ppm for methoxyfenozide in/on the

‘‘Crop Group 11; Pome Fruits Group.’’

2. Magnitude of the residue in cotton.

An adequate number of geographically

representative field trials were

submitted to support the proposed use

on cotton. These studies were

conducted via use patterns

approximating those proposed by this

petition. The results of the cotton field

trials indicate that residues of

methoxyfenozide will not exceed the

proposed tolerance level of 2.0 ppm in/

on cottonseed when treated as

proposed. Residues of methoxyfenozide

ranged from 0.060 to 1.8 ppm in/on

cottonseed treated with the 80% WP

formulation according to the maximum

proposed use pattern. Residues of

methoxyfenozide did not vary

significantly in cotton treated with ULV

spray applications (1 GPA) versus

standard volume applications (10–30

GPA). Residues ranged from 0.13 to 0.32

ppm and from 0.12 to 0.66 ppm in/on

cotton treated in side-by-side plots with

ULV and standard volume applications,

respectively. Rohm and Haas Company

requested the proposed tolerance on

cottonseed at 2.0 ppm. However, EPA

has determined that it should be

‘‘cotton, undelinted seed’’ at 2.0 ppm.

The results of the cotton field trials

indicate that residues of

methoxyfenozide may exceed the

proposed tolerance level of 25 ppm in/

on cotton gin byproducts when treated

as proposed. Residues of

methoxyfenozide ranged from 3.8 to

31.2 ppm in/on cotton gin byproducts

treated with the 80% WP formulation

Federal Register / Vol. 65, No. 129 / Wednesday, July 5, 2000 / Rules and Regulations 41363

according to the maximum proposed

use pattern. Based on these data, the

tolerance for residues of

methoxyfenozide in/on cotton gin

byproducts must be raised to 35 ppm.

3. Magnitude of the residue in apple

processed commodities. The submitted

apple processing data are adequate for

the purposes of this petition. Residues

of methoxyfenozide did not concentrate

in juice but concentrated 6x in wet

pomace processed from whole apples

bearing detectable residues. Based on

the results of the apple processing

study, a tolerance for residues of

methoxyfenozide in apple juice is not

required. Rohm and Haas proposed a

tolerance level of 7.5 ppm for residues

of methoxyfenozide in/on apple wet

pomace. The maximum residue level of

methoxyfenozide expected in apple wet

pomace was 6.06 ppm, calculated by

multiplying the HAFT residue (1.01

ppm; see apple field trial) and the

observed concentration factor (6x).

Based on this calculation, a tolerance of

7.0 ppm for residues of

methoxyfenozide in/on ‘‘apple pomace,

wet’’ is appropriate.

4. Magnitude of the residue in

cottonseed processed commodities. The

submitted cotton processing data are

adequate for the purposes of this

petition. No concentration of

methoxyfenozide residues was observed

in hulls, meal, and oil processed from

undelinted cottonseed bearing

detectable residues. Based on the results

of the current processing study,

tolerances for residues of

methoxyfenozide in the processed

commodities of cotton are not required.

5. Residues in meat, milk, poultry,

and eggs. The submitted dairy cattle

feeding study is adequate for the

purpose of establishing tolerances for

secondary transfer of methoxyfenozide

residues in milk and ruminant tissues.

EPA has determined that the residues of

concern in milk and ruminant tissues

(except kidney and liver) are the parent

compound, methoxyfenozide. For liver

and kidney, the residues of concern are

the parent compound, methoxyfenozide,

and its metabolite RH–141,518. EPA

concludes that residues of

methoxyfenozide are not likely to

exceed the proposed tolerances of 0.02

ppm in the milk and meat of cattle,

goats, hogs, horses, and sheep. EPA

further concludes that residues of

methoxyfenozide are not likely to

exceed the proposed tolerance of 0.1

ppm in the fat of cattle, goats, hogs,

horses, and sheep as a result of the

proposed uses. EPA also concludes that

residues of methoxyfenozide and its

metabolite RH—141,518 are not likely to

exceed 0.1 ppm in liver and 0.02 ppm

in meat byproduct (except liver) of

cattle, goat, hogs, horses, and sheep. The

proposed tolerances did not include

residues in tissues of horses. However,

horses must be a part of the tolerance.

Rohm and Haas Company requested a

waiver from the requirements to: (i)

Conduct a poultry feeding study; (ii)

propose tolerances for methoxyfenozide

residues of concern in eggs and poultry

tissues; and (iii) provide enforcement

method(s) for determination of

methoxyfenozide residues of concern in

eggs and poultry tissues. The waiver

request is based on the maximum

theoretical dietary burden of

methoxyfenozide for poultry animals as

well as the results of the poultry

metabolism study. The only poultry

feed item associated with this petition is

cotton meal, which would contribute a

maximum theoretical dietary burden for

methoxyfenozide at 0.4 ppm.

The poultry metabolism study

reviewed in this petition was conducted

at feeding levels of 58 ppm (MOP-label),

60 ppm (DMP-label), and 68 ppm (TBlabel) which are equivalent to 145x,

150x, and 170x, respectively, the

maximum theoretical dietary burden for

poultry. Assuming a linear relationship

between dose and residues, the

expected residues in eggs and poultry

tissues would be below the LOD for

methods used to measure residues in

poultry products. EPA concludes that

there is no reasonable expectation of

finite residues in eggs and poultry

tissues and that a poultry feeding study

is not required at this time. However,

should the dietary burden for poultry

increase due to the addition of

methoxyfenozide-treated poultry feed

items through new uses, a poultry

feeding study may be required. If a

poultry feeding study is required in the

future, then all tissues should be

analyzed for residues of

methoxyfenozide and its metabolite

RH–141,518.

D. International Residue Limits

There are no established or proposed

Codex, Canadian or Mexican limits for

residues of methoxyfenozide in/on plant

or animal commodities. Therefore, no

compatibility issues exist with regard to

the proposed U.S. tolerances discussed

in this petition review.

E. Rotational Crop Restrictions

A confined rotational crop study was

submitted and reviewed. The petitioner

has proposed a 30-day plantback

interval for all crops not listed on the

product label. The confined rotational

crop study demonstrated that

methoxyfenozide may accumulate in

rotational crop commodities at > 0.01

ppm at 30- and 90-day plantback

intervals. The rotational crop

restrictions included on the submitted

label are not adequate. The label must

include the following rotational crop

restrictions: Cotton may be rotated to

treated fields at any time. Leafy

vegetables (except Brassica vegetables)

and root and tuber vegetables may be

rotated to treated fields 1-year following

application of methoxyfenozide.

Rotation to all other crops is prohibited.

V. Conclusion

Therefore, the tolerances are

established for residues of

methoxyfenozide in or on cotton,

undelinted seed; cotton gin byproducts;

pome fruit; apple pomace, wet; milk;

meat of cattle, goats, hogs, horses and

sheep and fat of cattle, goats, hogs,

horses and sheep at 2.0, 35.0, 1.5, 7.0,

0.02, 0.02, 0.1 ppm respectively and for

the combined residues of

methoxyfenozide and its glucuronide

metabolite in liver of cattle, goats, hogs,

horses and sheep and meat byproducts

(except liver) of cattle, goats, hogs,

horses and sheep at 0.1 and 0.02 ppm

respectively.

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–300983 in the subject line

on the first page of your submission. All

requests must be in writing, and must be

41364 Federal Register / Vol. 65, No. 129 / Wednesday, July 5, 2000 / Rules and Regulations

mailed or delivered to the Hearing Clerk

on or before September 5, 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, Ariel Rios Bldg.,

1200 Pennsylvania Ave., NW.,

Washington, DC 20460. You may also

deliver your request to the Office of the

Hearing Clerk in Rm. M3708, Waterside

Mall, 401 M St., SW., Washington, DC

20460. The Office of the Hearing Clerk

is open from 8 a.m. to 4 p.m., Monday

through Friday, excluding legal

holidays. The telephone number for the

Office of the Hearing Clerk is (202) 260–

4865.

2. Tolerance fee payment. If you file

an objection or request a hearing, you

must also pay the fee prescribed by 40

CFR 180.33(i) or request a waiver of that

fee pursuant to 40 CFR 180.33(m). You

must mail the fee to: EPA Headquarters

Accounting Operations Branch, Office

of Pesticide Programs, P.O. Box

360277M, Pittsburgh, PA 15251. Please

identify the fee submission by labeling

it ‘‘Tolerance Petition Fees.’’

EPA is authorized to waive any fee

requirement ‘‘when in the judgement of

the Administrator such a waiver or

refund is equitable and not contrary to

the purpose of this subsection.’’ For

additional information regarding the

waiver of these fees, you may contact

James Tompkins by phone at (703) 305–

5697, by e-mail at

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

request for information to Mr. Tompkins

at Registration Division (7505C), Office

of Pesticide Programs, Environmental

Protection Agency, Ariel Rios Bldg.,

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, Ariel Rios Bldg.,

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–300983, to: Public

Information and Records Integrity

Branch, Information Resources and

Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, Ariel Rios Bldg.,

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 (October 4, 1993,

58 FR 51735). 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 (May 19,

1998, 63 FR 27655); special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (February 16, 1994, 59 FR

7629); or require OMB review or any

Agency action under Executive Order

13045, entitled Protection of Children

from Environmental Health Risks and

Safety Risks (April 23, 1997, 62 FR

19885). 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 (August 4, 1999, 64 FR

43255). 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).

Federal Register / Vol. 65, No. 129 / Wednesday, July 5, 2000 / Rules and Regulations 41365

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 United States 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 13, 2000.

Suzan 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 180.544 is added to read as

follows:

§ 180.544 Methoxyfenozide; tolerances for

residues.

(a) General. (1) Tolerances are

established for residues of the

insecticide methoxyfenozide; benzoic

acid, 3-methoxy-2-methyl-2-(3,5-

dimethylbenzoyl)-2-(1,1-

dimethylethyl)hydrazide in or on the

following agricultural commodities:

Commodity Parts per

million

Apple pomace, wet .................................................................................................................................................................................. 7.0

Cotton gin byproducts .............................................................................................................................................................................. 35

Cotton, undelinted seed ........................................................................................................................................................................... 2.0

Fat of cattle, goats, hogs, horses and sheep .......................................................................................................................................... 0.1

Meat of cattle, goats, hogs, horses and sheep ....................................................................................................................................... 0.02

Milk ........................................................................................................................................................................................................... 0.02

Pome fruits crop group ............................................................................................................................................................................ 1.5

(2) Tolerances are established for the

combined residues of methoxyfenozide;

benzoic acid, 3-methoxy-2-methyl-2-

(3,5-dimethylbenzoyl)-2-(1,1-

dimethylethyl)hydrazide and its

glucuronide metabolite in or on the

following agricultural commodities:

Commodity Parts per

million

Liver of cattle, goats, hogs, horses and sheep ....................................................................................................................................... 0.1

Meat byproducts (except liver) of cattle, goats, hogs, horses and sheep .............................................................................................. 0.02

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 00–16801 Filed 7–3–00; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300997; FRL–6555–3]

RIN 2070–AB78

Bacillus subtilis Strain QST 713;

Exemption from the Requirement of a

Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes an

exemption from the requirement of a

tolerance for residues of the Bacillus

subtilis strain QST 713 in or on all raw

agricultural commodities when applied/

used according to label instructions.

AgraQuest, Inc. submitted a petition to

EPA under the Federal Food, Drug, and

Cosmetic Act (FFDCA), as amended by

the Food Quality Protection Act of 1996

(FQPA), requesting an exemption from

the requirement of a tolerance. This

regulation eliminates the need to

establish a maximum permissible level

for residues of Bacillus subtilis strain

QST 713.

DATES: This regulation is effective July

5, 2000. Objections and requests for

hearings, identified by docket control

number [OPP–300997], must be

received by EPA, on or before

September 5, 2000.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, electronically, or in person. Please

follow the detailed instructions for each

method as provided in Unit IX. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number [OPP–300997] in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Susanne Cerrelli, c/o Product

Manager (PM) 90, Biopesticides and

Pollution Prevention Division (7511C),

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: (703)

308–8077; and e-mail address:

cerrelli.susanne@epa.gov.

SUPPLEMENTARY INFORMATION: