28386 Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Rules and Regulations

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 FIFRA

section 18 petition under FFDCA

section 408, 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.’’

V. 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: May 9, 2001.

Janet L. Anderson,

Director, Biopesticide and Pollution

Prevention Division.

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 180.1206 is revised to read

as follows:

§ 180.1206 Aspergillus flavus AF36.

Aspergillus flavus AF36 is

temporarily exempt from the

requirement of a tolerance in or on

cotton when used on cotton in Arizona

in accordance with the Experimental

Use Permit 69224–EUP–1. The

temporary exemption from a tolerance

will expire on December 30, 2003.

[FR Doc. 01–12900 Filed 5–22–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301132; FRL–6784–7]

RIN 2070–AB78

Thiamethoxam; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

tolerances for combined residues of

thiamethoxam and its metabolite in or

on tuberous and corm vegetables crop

subgroup, fruiting vegetables crop

group, tomato paste, cucurbit vegetables

crop group, and pome fruits crop group.

Syngenta Crop Protection, Inc.

requested these tolerances under the

Federal Food, Drug, and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996.

DATES: This regulation is effective May

23, 2001. Objections and requests for

hearings, identified by docket control

number OPP–301132, must be received

by EPA on or before July 23, 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–301132 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Dani Daniel, Registration Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW.,Washington,

DC 20460; telephone number: (703)

305–5409; and e-mail address:

daniel.dani@epa.gov.

SUPPLEMENTARY INFORMATION:

Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Rules and Regulations 28387

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer, or pesticide

manufacturer. Potentially affected

categories and entities may include, but

are not limited to:

Categories NAICS Examples of Potentially Affected Entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations’’, ‘‘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–301132. 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 5, 1999

(64 FR 34153) (FRL–6072–7), 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 (9F5051) for tolerances by

Syngenta Crop Protection, P.O. Box

18300 Greensboro, NC 27419–8300.

This notice included a summary of the

petition prepared by Syngenta Crop

Protection, the registrant. There were no

comments received in response to the

notice of filing.

The petition requested that 40 CFR

180.565 be amended by establishing

tolerances for combined residues of the

insecticide thiamethoxam, 3-[(2-chloro5-thiazolyl)methyl]tetrahydro-5-methylN-nitro-4H-1,3,5-oxadiazin-4-imine and

its metabolite (N-(2-chloro-thiazol-5-

ylmethyl)-N ′-methyl-N ′′-nitroguanidine) in or on the raw agricultural

commodities: tuberous and corm

vegetables crop subgroup at 0.02 ppm,

cucurbit vegetables crop group at 0.20

ppm, pome fruit crop group at 0.20

ppm, fruiting vegetables crop group at

0.25 ppm and tomato paste at 0.80 ppm.

Section 408(b)(2)(A)(i) of the FFDCA

allows EPA to establish a tolerance (the

legal limit for a pesticide chemical

residue in or on a food) only if EPA

determines that the tolerance is ‘‘safe.’’

Section 408(b)(2)(A)(ii) defines ‘‘safe’’ to

mean that‘‘ there is a reasonable

certainty that no harm will result from

aggregate exposure to the pesticide

chemical residue, including all

anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

408(b)(2)(C) requires EPA to give special

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue....’’

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. For

further discussion of the regulatory

requirements of section 408 and a

complete description of the risk

assessment process, see the final rule on

Bifenthrin Pesticide Tolerances (62 FR

62961, November 26, 1997) (FRL–5754–

7).

III. Aggregate Risk Assessment and

Determination of Safety

Consistent with section 408(b)(2)(D),

EPA has reviewed the available

scientific data and other relevant

information in support of this action.

EPA has sufficient data to assess the

hazards of and to make a determination

on aggregate exposure, consistent with

section 408(b)(2), for a tolerance for

combined residues of thiamethoxam

and its metabolite in or on tuberous and

corm vegetables crop subgroup at 0.02

ppm, fruiting vegetables crop group at

0.25 ppm, tomato paste at 0.80 ppm,

cucurbit vegetables crop group at 0.20

ppm, and pome fruits crop group at 0.20

ppm. EPA’s assessment of exposures

and risks associated with establishing

these tolerances follows.

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered its validity,

completeness, and reliability as well as

the relationship of the results of the

studies to human risk. EPA has also

considered available information

concerning the variability of the

sensitivities of major identifiable

subgroups of consumers, including

infants and children. The nature of the

toxic effects caused by thiamethoxam

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.

28388 Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Rules and Regulations

TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY

Guideline No. Study Type Results

870.3100 90–Day oral toxicity - rat NOAEL = 1.74 (males), 92.5 (females) mg/kg/day

LOAEL = 17.64 (males), 182.1 (females) mg/kg/day based on increased incidence of hyaline change of renal tubular epithelium

(males), fatty change in adrenal gland of females, liver changes in

females, all at the LOAEL.

870.3100 90–Day oral toxicity - mouse NOAEL = 1.41 (males), 19.2 (females) mg/kg/day

LOAEL = 14.3 (males), 231 (females) mg/kg/day based on increased

incidence of hepatocellular hypertrophy. At higher dose levels: decrease in bodyweight and bodyweight gain, necrosis of individual

hepatocytes, pigmentation of Kupffer cells, and lymphocytic infiltration of the liver in both sexes; slight hematologic effects and decreased absolute and relative kidney weights in males; and ovarian

atrophy, decreased ovary and spleen weights and increased liver

weights in females.

870.3150 90–Day oral toxicity - dog NOAEL = 8.23 (males), 9.27 (females) mg/kg/day

LOAEL = 32.0 (males), 33.9 (females) mg/kg/day based on slightly

prolonged prothrombin times and decreased plasma albumin and

A/G ratio (both sexes); decreased calcium levels and ovary weights

and delayed maturation in the ovaries (females); decreased cholesterol and phospholipid levels, testis weights, spermatogenesis, and

spermatic giant cells in testes (males).

870.3200 28–Day dermal toxicity - rat NOAEL = 250 (males), 60 (females) mg/kg/day

LOAEL = 1000 (males), 250 (females) mg/kg/day based on increased

plasma glucose, triglyceride levels, and alkaline phosphatase activity and inflammatory cell infiltration in the liver and necrosis of single hepatocytes in females and hyaline change in renal tubules

and a very slight reduction in body weight in males. At higher dose

levels in females, chronic tubular lesions in the kidneys and inflammatory cell infiltration in the adrenal cortex were observed.

870.3700a Prenatal developmental - rat Maternal NOAEL = 30 mg/kg/day

LOAEL = 200 mg/kg/day based on decreased body weight, body

weight gain, and food consumption.

Developmental NOAEL = 200 mg/kg/day

LOAEL = 750 mg/kg/day based on decreased fetal body weight and

anincreased incidence of skeletal anomalies.

870.3700b Prenatal developmental - rabbit Maternal NOAEL = 50 mg/kg/day

LOAEL = 150 mg/kg/day based on maternal deaths, hemorrhagic

uterine contents and hemorrhagic discharge, decreased body

weight and food intake during the dosing period.

Developmental NOAEL = 50 mg/kg/day

LOAEL = 150 mg/kg/day based on decreased fetal body weights, increased incidence of post-implantation loss and a slight increase in

the incidence of a few skeletal anomalies/variations.

870.3800 Reproduction and fertility effects - rat Parental/Systemic NOAEL = 1.84 (males), 202.06 (females)mg/kg/

day

LOAEL = 61.25 (males), not determined (females) mg/kg/day based

on increased incidence of hyaline change in renal tubules in F0

and F1 males.

Reproductive NOAEL = 0.61 (males), 202.06 (females) mg/kg/day

LOAEL = 1.84 (males), not determined (females) mg/kg/day based

on increased incidence and severity of tubular atrophy observed in

testes of the F1 generation males.

Offspring NOAEL = 61.25 (males), 79.20 (females) mg/kg/day

LOAEL = 158.32 (males), 202.06 (females) mg/kg/day based on reduced body weight gain during the lactation period in all litters .

870.4100 Chronic toxicity - dog NOAEL = 4.05 (males), 4.49 (females) mg/kg/day

LOAEL = 21.0 (males), 24.6 (females) mg/kg/day based on increase

in creatinine in both sexes, transient decrease in food consumption

in females, and occasional increase in urea levels, decrease in

ALT, and atrophy of seminiferous tubules in males.

870.4200 Carcinogenicity - mouse NOAEL = 2.63 (males), 3.68 (females) mg/kg/day

Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Rules and Regulations 28389

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

Guideline No. Study Type Results

LOAEL = 63.8 (males), 87.6 (females) mg/kg/day based on

hepatocyte hypertrophy, single cell necrosis, inflammatory cell infiltration, pigment deposition, foci of cellular alteration, hyperplasia of

Kupffer cells and increased mitotic activity; also, an increase in the

incidence of hepatocellular adenoma (both sexes). At higher doses,

there was an increase in the incidence of hepatocellular adenocarcinoma (both sexes) and the number of animals with multiple tumors. evidence of carcinogenicity

870.4300 Combined chronic carcinogenicity - rat NOAEL = 21.0 (males), 50.3 (females) mg/kg/day

LOAEL = 63.0 (males), 155 (females) mg/kg/day based on increased

incidence of lymphocytic infiltration of the renal pelvis and chronic

nephropathy in males and decreased body weight gain, slight increase in the severity of hemosiderosis of the spleen, foci of cellular alteration in liver and chronic tubular lesions in kidney in females. no evidence of carcinogenicity

870.5100 and

870.5265

Gene mutation in S. typhimurium and E. coli No evidence of gene mutation when tested up to 5,000 μg/plate.

There was no evidence of cytotoxicity.

870.5265 Gene mutation in S. typhimurium No evidence of gene mutation when tested up to 5,000 μg/plate.The

S9 fraction was from non-induced mouse liver, Aroclor 1254 induced mouseliver, or thiamethoxam induced mouse liver, following

dietary administration of thiamethoxam for 14 days at concentrations up to 2,500 ppm.

870.5300 Gene mutation in chinese hamster V79 cells at

HGPRT locus

No evidence of gene mutation when tested up to solubility limit.

870.5375 CHO cell cytogenetics No evidence of chromosomal aberrations when tested up tocytotoxic

or solubility limit concentrations.

870.5395 In vivo mouse bone marrow micronucleus Negative when tested up to levels of toxicity in whole animals;however no evidence of target cell cytotoxicity.

870.5550 UDS assay Negative when tested up to precipitating concentrations

870.6200a Acute neurotoxicity screening battery - rat NOAEL = 100 mg/kg/day

LOAEL = 500 mg/kg/day based on drooped palpebral closure, decrease in rectal temperature and locomotor activity and increase in

forelimb grip strength (males only). At higher dose levels, mortality,

abnormal body tone, ptosis, impaired respiration, tremors, longer

latency to first step in the open field, crouched-over posture, gait

impairment, hypo-arousal, decreased number of rears, uncoordinated landing during the righting reflex test, slight lacrimation (females only) and higher mean average input stimulus value in the

auditory startle response test (males only).

870.6200b Subchronic neurotoxicity screening battery - rat NOAEL = 95.4 (males), 216.4 (females) mg/kg/day, both highestdose

tested.

LOAEL = not determined. No treatment-related observations at any

dose level.

LOAEL was not achieved. May not have been tested at sufficiently

high dose levels; however, new study not required because the

weight of the evidence from the other toxicity studies indicates no

evidence of concern.

28390 Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Rules and Regulations

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

Guideline No. Study Type Results

870.7485 Metabolism and pharmacokinetics - rat Absorbed rapidly and extensively, widely distributed, followed byvery

rapid elimination, mostly in urine. Highest tissue concentrations in

skeletal muscle: 10–15% of administered dose. Half life times from

tissues ranged from 2–6 hours. Tissue residues after 7 days extremely low. Approximately 84–95% of administered dose excreted

in urine and 2.5–6% excreted in feces within 24 hours. Greater

than 0.2% detected in expired air. Most excreted as unchanged

parent: 70–80% of dose. The major biotransformation reaction is

cleavage of oxadiazine ring to corresponding nitroguanidine compound. Minor pathways: (1) cleavage of nitroguanidine group yielding guanidine derivative, (2) hydrolysis of guanidine group to corresponding urea, (3) demethylation of guanidine group, and (4)

substitution of the chlorine of the thiazole ring by glutathione.

Cleavage between thiazole- and oxadiazine ring occurs to a small

extent. Glutathione derivatives prone to further degradation of the

glutathione moiety resulting in various sulfur-containing metabolites

(e.g. mercapturates, sulfides, and sulfoxides). Both the thiazole and

oxadiazine moiety susceptible to oxidative attack. Small but measurable amounts exhaled, most probably as CO2. Metabolites eliminated very rapidly. Enterohepatic circulation negligible.

870.7485 Metabolism and pharmacokinetics - mouse Approximately 72% of administered dose excreted in the urine;19%

excreted in feces. Small but measurable amount detected in expired air(approximately 0.2% of dose).

Predominant metabolites: unchanged parent (33–41% of administered dose; 2 other metabolites: 8–12% and 9–18% of administered dose. These are the same structures that were most commonly observed in rat excreta, however the proportions are quite

different in mouse excreta. One additional significant metabolite

(mouse R6) was isolated from feces samples. Between 30–60% of

the administered dose was excreted as metabolites.

870.7600 Dermal penetration - rat Estimates of dermal absorption were based on the sum

ofradioactivity in skin test site, urine, feces, blood, and carcass.

Percentage dermal absorption is 27.0, highest mean dermal absorption value across all groups. This value is considered to represent the potential cumulative dermal absorption of test material

that might occur after a 10 hour dermal exposure. As the study design did not permit analysis of the fate of skin bound residues, residues at skin site were included in determination of dermal absorption.

Hepatic cell proliferation study - mouse NOAEL = 16 (males), 20 (females) mg/kg/day

LOAEL = 72 (males), 87 (females) mg/kg/day based on proliferative

activity of hepatocytes. At higher dose levels, increases in absolute

and relative liver wts, speckled liver, hepatocellular glycogenesis/

fatty change, hepatocellular necrosis, apoptosis and pigmentation

were observed.

Replicative DNA

synthesis

28–day feeding study - male rat NOAEL = 711 mg/kg/day (highest dose tested)

LOAEL = not established. Immunohistochemical staining of liver sections from control and high-dose animals for proliferating cell nuclear antigen gave no indication for a treatment-related increase in

the fraction of DNA synthesizing hepatocytes in S-phase. CGA

293343 did not stimulate hepatocyte cell proliferation in male rats.

Special study to

assess liver biochemistry in

mouse

NOAEL = 17 (males), 20 (females) mg/kg/day

LOAEL = 74 (males), 92 (females) mg/kg/day based on marginal to

slight increases in absolute and relative liver weights, a slight increase in the microsomal protein content of the livers, moderate increases in the cytochrome P450 content, slight to moderate increases in the activity of several microsomal enzymes, slight to

moderate induction of cytosolic glutathione S-transferase activity.

Treatment did not affect peroxisomal fatty acid β-oxidation.

Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Rules and Regulations 28391

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.

For dietary risk assessment (other

than cancer) the Agency uses the UF to

calculate an acute or chronic reference

dose (acute RfD or chronic RfD) where

the RfD is equal to the NOAEL divided

by the appropriate UF (RfD = NOAEL/

UF). Where an additional safety factor is

retained due to concerns unique to the

FQPA, this additional factor is applied

to the RfD by dividing the RfD by such

additional factor. The acute or chronic

Population Adjusted Dose (aPAD or

cPAD) is a modification of the RfD to

accommodate this type of FQPA Safety

Factor.

For non-dietary risk assessments

(other than cancer) the UF is used to

determine the LOC. For example, when

100 is the appropriate UF (10X to

account for interspecies differences and

10X for intraspecies differences) the

LOC is 100. To estimate risk, a ratio of

the NOAEL to exposures (margin of

exposure (MOE) = NOAEL/exposure) is

calculated and compared to the LOC.

The linear default risk methodology

(Q*) is the primary method currently

used by the Agency to quantify

carcinogenic risk. The Q* approach

assumes that any amount of exposure

will lead to some degree of cancer risk.

A Q* is calculated and used to estimate

risk which represents a probability of

occurrence of additional cancer cases

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

in a million). Under certain specific

circumstances, MOE calculations will

be used for the carcinogenic risk

assessment. In this non-linear approach,

a ‘‘point of departure’’ is identified

below which carcinogenic effects are

not expected. The point of departure is

typically a NOAEL based on an

endpoint related to cancer effects

though it may be a different value

derived from the dose response curve.

To estimate risk, a ratio of the point of

departure to exposure (MOEcancer = point

of departure/exposures) is calculated. A

summary of the toxicological endpoints

for thiamethoxam used for human risk

assessment is shown in the following

Table 2:

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

ASSESSMENT

Exposure Scenario Dose Used in Risk

Assessment, UF

FQPA SF* and Level of

Concern for Risk

Assessment

Study and Toxicological Effects

Acute Dietary general population including infantsand

children

NOAEL = 100 mg/kg/

day; UF = 100; Acute

RfD = 1 mg/kg/day

FQPA SF = 10; aPAD

= acute RfD/FQPA

SF = 0.1 mg/kg/day

Acute mammalian neurotoxicity study in the rat

LOAEL = 500 mg/kg/day based on treatment-related

neurobehavioraleffects observed in the FOB and LMA

testing (drooped palpebral closure,decreased rectal temperature and locomotor activity, increased forelimbgrip

strength)

Chronic Dietary all populations NOAEL = 0.6 mg/kg/

day; UF = 100;

Chronic RfD = 0.006

mg/kg/day

FQPA SF = 10; cPAD

= chronic RfD/FQPA

SF = 0.0006 mg/kg/

day

2-Generation reproduction study

LOAEL = 1.8 mg/kg/day based on increased incidence and

severity oftubular atrophy in testes of F1 generation

males.

Oral Nondietary (all durations) NOAEL = 0.6 mg/kg/

day

LOC for MOE = 1,000

(Residential)

2-Generation reproduction study

LOAEL = 1.8 mg/kg/day based on increased incidence and

severity of tubular atrophy in testes of F1 generation

males.

Dermal (all durations) (Residential)Oral study NOAEL= 0.6

mg/kg/day (dermal

absorptionrate =

27%)

LOC for MOE = 1,000

(Residential)

2-Generation reproduction study

LOC for MOE = 100

(Occupational)

LOAEL = 1.8 mg/kg/day based on increased incidence and

severity of tubular atrophy in testes of F1 generation

males.

Inhalation (all durations) (Residential)Oral study NOAEL =

0.6 mg/kg/day (inhalation absorption rate

=100%)

LOC for MOE = 1,000

(Residential)

2-Generation reproduction study

LOC for MOE = 100

(Occupational)

LOAEL = 1.8 mg/kg/day based on increased incidence and

severity oftubular atrophy in testes of F1 generation

males.

28392 Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Rules and Regulations

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

ASSESSMENT—Continued

Exposure Scenario Dose Used in Risk

Assessment, UF

FQPA SF* and Level of

Concern for Risk

Assessment

Study and Toxicological Effects

Cancer (oral, dermal, inhalation)Q1* (mg/kg/day)-1 is

3.77 x 10-2

Greater than 1 x 10-6 Likely carcinogen for humans based on increased

incidenceof hepatocellular adenomas and carcinomas in

male and female mice.Quantification of risk based on

most potent unit risk: male mouse liveradenoma and/or

carcinoma combined tumor rate. The upper bound

estimateof unit risk, Q1* (mg/kg/day)-1 is 3.77 x 10-2 in

human equivalents.

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

C. Exposure Assessment

1. Dietary exposure from food and

feed uses. Tolerances have been

established (40 CFR 180.565) for the

combined residues of thiamethoxam

and its metabolite, in or on a variety of

raw agricultural commodities. The

following raw agricultural commodities

have established tolerances: barley,

canola, cotton, sorghum, wheat, milk,

and the meat and meat byproducts of

cattle, goats, horses, and sheep. Risk

assessments were conducted by EPA to

assess dietary exposures from

thiamethoxam in food as follows:

i. Acute exposure. Acute dietary risk

assessments are performed for a fooduse pesticide if a toxicological study has

indicated the possibility of an effect of

concern occurring as a result of a one

day or single exposure. The 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 acute

exposure assessments: tolerence level

residues and 100% crop treated.

ii. Chronic exposure.In conducting

this chronic dietary risk assessment the

DEEM analysis evaluated the

individual food consumption as

reported by respondents in the USDA

1989–1992–nationwide CSFII and

accumulated exposure to the chemical

for each commodity. The following

assumptions were made for the chronic

exposure assessments: percent crop

treated (based on projected market

shares) and anticipated residues (Tier

3).

iii. Cancer. The dietary exposure for

determining cancer risk is based on the

chronic exposure explained in the

previous paragraph using the same

assumptions.

Section 408(b)(2)(E) authorizes EPA to

use available data and information on

the anticipated residue levels of

pesticide residues in food and the actual

levels of pesticide chemicals that have

been measured in food. If EPA relies on

such information, EPA must require that

data be provided 5 years after the

tolerance is established, modified, or

left in effect, demonstrating that the

levels in food are not above the levels

anticipated. Following the initial data

submission, EPA is authorized to

require similar data on a time frame it

deems appropriate. As required by

section 408(b)(2)(E), EPA will issue a

data call-in for information relating to

anticipated residues to be submitted no

later than 5 years from the date of

issuance of this tolerance.

Section 408(b)(2)(F) states that the

Agency may use data on the actual

percent of food treated for assessing

chronic dietary risk only if the Agency

can make the following findings:

Condition 1, that the data used are

reliable and provide a valid basis to

show what percentage of the food

derived from such crop is likely to

contain such pesticide residue;

Condition 2, that the exposure estimate

does not underestimate exposure for any

significant subpopulation group; and

Condition 3, if data are available on

pesticide use and food consumption in

a particular area, the exposure estimate

does not understate exposure for the

population in such area. In addition, the

Agency must provide for periodic

evaluation of any estimates used. To

provide for the periodic evaluation of

the estimate of percent crop treated

(PCT) as required by section

408(b)(2)(F), EPA may require

registrants to submit data on PCT.

The Agency used percent crop treated

(PCT information as follows in Table 3:

TABLE 3.—THIAMETHOXAM USES AND ESTIMATES OF PERCENT CROP TREATED

Crop Percent Crop Treated

Tuberous and Corm Vegetables - Crop Subgroup 1 C ...................................................................................................... 9

Fruiting Vegetables (Except Cucurbits - Crop Group 8 ...................................................................................................... 15

Cucumbers ........................................................................................................................................................................... 5

Melons ................................................................................................................................................................................. 13

Casabas ............................................................................................................................................................................... 44

Crenshaws ........................................................................................................................................................................... 44

Squash ................................................................................................................................................................................. 44

Pumpkin ............................................................................................................................................................................... 44

Apples .................................................................................................................................................................................. 15–20

Crabapples ........................................................................................................................................................................... 53

Pears .................................................................................................................................................................................... 9

Quinces ................................................................................................................................................................................ 53

Loquats ................................................................................................................................................................................ 53

Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Rules and Regulations 28393

The Agency used information

provided by the registrant to determine

percent crop treated based on projected

percent market share information. The

Agency believes that the procedures

used were the best available, because

thiamethoxam is a new chemical and

has never been used. As to Conditions

2 and 3, regional consumption

information and consumption

information for significant

subpopulations is taken into account

through EPA’s computer-based model

for evaluating the exposure of

significant subpopulations including

several regional groups. Use of this

consumption information in EPA’s risk

assessment process ensures that EPA’s

exposure estimate does not understate

exposure for any significant

subpopulation group and regional

populations.

2. Dietary exposure from drinking

water. The Agency lacks sufficient

monitoring exposure data to complete a

comprehensive dietary exposure

analysis and risk assessment for

thiamethoxam 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

thiamethoxam.

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

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

thiamethoxam they are further

discussed in the aggregate risk sections

below.

Based on the PRZM/EXAMS and SCIGROW models the estimated

environmental concentrations (EECs) of

thiamethoxam for acute exposures are

estimated to be 8.0 parts per billion

(ppb) for surface water and 1.94 ppb for

ground water. The EECs for chronic

exposures are estimated to be 0.6 ppb

for surface water, and 1.94 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).

Thiamethoxam is not registered for

use on any sites that would result in

residential exposure. Although such

uses have been requested, they are not

being assessed at this time.

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

thiamethoxam 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, thiamethoxam

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 thiamethoxam 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 database 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.

The developmental toxicity studies

indicated no quantitative or qualitative

evidence of increased susceptibility of

rat or rabbit fetus to in utero exposure

based on the fact that the developmental

NOAELs are either higher than or equal

to the maternal NOAELs. However, the

reproductive studies indicate effects in

male rats in the form of increased

incidence and severity of testicular

tubular atrophy. These data are

considered to be evidence of increased

quantitative susceptibility for male pups

when compared to the parents.

iii. Conclusion. Based on: (a) effects

on endocrine organs observed across

species; (b) the significant decrease in

alanine amino transferase levels in the

companion animal studies and in the

dog studies; (c) the mode of action of

this chemical in insects (interferes with

the nicotinic acetyl choline receptors of

the insect’s nervous system) thus a

developmental neurotoxicity study is

required; (d) the transient clinical signs

of neurotoxicity in several studies

across species; and (e) the suggestive

evidence of increased quantitative

susceptibility in the rat reproduction

study, the Agency is retaining the FQPA

factor which is l0X.

E. Aggregate Risks and Determination of

Safety

To estimate total aggregate exposure

to a pesticide from food, drinking water,

and residential uses, the Agency

28394 Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Rules and Regulations

calculates DWLOCs which are used as a

point of comparison against the model

estimates of a pesticide’s concentration

in water (EECs). DWLOC values are not

regulatory standards for drinking water.

DWLOCs are theoretical upper limits on

a pesticide’s concentration in drinking

water in light of total aggregate exposure

to a pesticide in food and residential

uses. In calculating a DWLOC, the

Agency determines how much of the

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

available for exposure through drinking

water e.g., allowable chronic water

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

food + residential exposure). This

allowable exposure through drinking

water is used to calculate a DWLOC.

A DWLOC will vary depending on the

toxic endpoint, drinking water

consumption, and body weights. Default

body weights and consumption values

as used by the USEPA Office of Water

are used to calculate DWLOCs: 2L/70 kg

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

and 1L/10 kg (child). Default body

weights and drinking water

consumption values vary on an

individual basis. This variation will be

taken into account in more refined

screening-level and quantitative

drinking water exposure assessments.

Different populations will have different

DWLOCs. Generally, a DWLOC is

calculated for each type of risk

assessment used: acute, short-term,

intermediate-term, chronic, and cancer.

When EECs for surface water and

groundwater are less than the calculated

DWLOCs, the Office of Pesticide

Programs (OPP) concludes with

reasonable certainty that exposures to

the pesticide in drinking water (when

considered along with other sources of

exposure for which OPP has reliable

data) would not result in unacceptable

levels of aggregate human health risk at

this time. Because OPP considers the

aggregate risk resulting from multiple

exposure pathways associated with a

pesticide’s uses, levels of comparison in

drinking water may vary as those uses

change. If new uses are added in the

future, OPP will reassess the potential

impacts of residues of the pesticide in

drinking water as a part of the aggregate

risk assessment process.

1. Acute risk. Using the exposure

assumptions discussed in this unit for

acute exposure, the acute dietary

exposure from food to thiamethoxam

will occupy 3% of the aPAD for the U.S.

population, 2% of the aPAD for females

13–50 years old, 8% of the aPAD for all

infants less than 1 year old and 7% of

the aPAD for children 1–6 years old. In

addition, there is potential for acute

dietary exposure to thiamethoxam in

drinking water. The surface water EEC

is 8.0 μg/L and the ground water EEC is

1.94 μg/L. Since the surface water value

is greater than the ground water value,

the surface water value will be used for

comparison purposes and will protect

for any concerns for ground water

concentrations. After calculating

DWLOCs and comparing them to the

EECs for surface water, EPA does not

expect the aggregate exposure to exceed

100% of the aPAD.

TABLE 4.—AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO THIAMETHOXAM

Population Subgroupa aPAD(mg/

kg)

%aPAD

(Food)

Surface

Water

DWEC

(ppb)

Ground

Water

DWEC(ppb)

Acute

DWLOC

(ppb)b

U.S. General Population 0.1 3 8 1.94 3,400

All infants (< 1 year) 0.1 8 8 1.94 920

Children (1–6 years) 0.1 7 8 1.94 930

Children (7–12 years) 0.1 4 8 1.94 960

Females (13–50 years) 0.1 2 8 1.94 2,900

aPopulation subgroups shown include the U.S. general population and the maximally exposed subpopulation of adults, infants and children,

and women of child-bearing age for each exposure scenario. bDWLOC = Maximum Water Exposure (mg/kg/day) — 1,000 μg/mg — body weight (70 kg general population/males 13+, 60 kg females 13+,

10 kg infants and children) ÷ Water Consumption (2 L/day adults, 1 L/day infants and children). Maximum water exposure = aPAD - dietary exposure (mg/kg/day)

2. Chronic risk. Using the exposure

assumptions described in this unit for

chronic exposure, EPA has concluded

that exposure to thiamethoxam from

food will utilize 5% of the cPAD for the

U.S. population, 13% of the cPAD for

all infants < 1 year old and 13% of the

cPAD for children 1–6 years old.

Proposed residential uses are not being

addressed in this risk assessment. In

addition to chronic dietary exposure,

there is potential for chronic dietary

exposure to thiamethoxam in drinking

water. The surface water EEC is 0.6 μg/

L and the groundwater EEC is 1.94 μg/

L. Since the groundwater value is

greater than the surface water value, the

groundwater value will be used for

comparison purposes and will protect

for any concerns for surface water

concentrations. After calculating the

DWLOCs and comparing them to the

EECs for groundwater, EPA does not

expect the aggregate exposure to exceed

100% of the cPAD.

TABLE 5.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO THIAMETHOXAM

Population Subgroup cPAD mg/

kg/day

cPAD

(Food)

Surface

Water

DWEC

(ppb)

Ground

Water

DWEC

(ppb)

DWLOC

(ppb)

U.S. Population 0.0006 5 0.6 1.94 20

All infants (< 1 year) 0.0006 13 0.6 1.94 5.2

Children (1–6 years) 0.0006 13 0.6 1.94 5.2

Children (7–12 years) 0.0006 7 0.6 1.94 5.6

Females (13–50 years) 0.0006 3 0.6 1.94 17

Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Rules and Regulations 28395

3. Short-term risk. Short-term

aggregate exposure takes into account

residential exposure plus chronic

exposure to food and water (considered

to be a background exposure level).

Thiamethoxam 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 does not exceed

the Agency’s level of concern.

4. Intermediate-term risk.

Intermediate-term aggregate exposure

takes into account residential exposure

plus chronic exposure to food and water

(considered to be a background

exposure level). Thiamethoxam 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

does not exceed the Agency’s level of

concern.

5. Aggregate cancer risk for U.S.

population. The cancer aggregate dietary

risk estimate was calculated in two

ways, one using the Agency’s 20%

estimated market share for apples and

the other using a 5% estimated market

share for apples (as indicated by the

registrant). The dietary (food only)

cancer risk is either 1.0 x 10-6 or 0.70

x 10-6 with the 20% or 5% estimated

market share for apples, respectively.

With the 20% market share, it is not

possible to estimate a DWLOC for

cancer based on an assumed negligible

risk value of 1.0 x 10-6. Using the latter

with 5% market share for apples, the

DWLOC is extremely low (0.23 ppb).

Therefore, for risk management

purposes, an assumed negligible risk

value of 3.0 x 10-6 will be used to

estimate the DWLOC for cancer. The

DWLOC for cancer aggregate risk (no

residential uses) is calculated using the

following equations:

DWLOCcancer(μg/L) = chronic water

exposure(mg/kg/day) x (body weight (kg))/

consumption (L) x 10-3 mg/μg

chronic water exposure (mg/kg/

day)=negligible risk/Q* - chronic food

exposure(mg/kg/day)

Assuming a risk value of 3 x 10-6,

(which is generally considered to be

within the range of 10-6, the risk value

considered to represent a negligible

cancer risk), for the 20% market share

for apples, the chronic water exposure

value is estimated to be:

3 x 10-6/3.77 x 10-2 - 0.000027 = 0.0000525

mg/kg/day

The DWLOCcancer = 0.0000525 mg/kg/day x

70 kg/2L x 10-3 mg/μg = 1.8 μg/L

Using the same equation, for the 5%

estimated market share for apples, the

DWLOCcancer = 2.1 μg/L.

The surface water EEC is 0.6 μg/L and

the ground water EEC is 1.94 μg/L.

Since the ground water value is greater

than the surface water value it will be

used for comparison purposes and will

protect for any concerns for surface

water concentrations. The estimated

chronic ground water value for

thiamethoxam (1.94 μg/L) is greater than

the DWLOCcancer for the general

population using the 20% market share

for apples. Using the 5% market share,

the DWLOCcancer is less than the

Agency’s level of concern.

The Agency used a screening level

model designed to estimate pesticide

concentrations in shallow groundwater.

Although the 20% market share for

apples results in EECs that are

marginally above the DWLOCcancer, a

number of factors lead EPA to believe

that the actual lifetime exposure

through drinking water will be less than

the DWLOCcancer. These reasons are as

follows:

i. Thiamethoxam is systemic. EPA’s

Tier 1 groundwater model assumes that

all of the product that is applied to the

crop is available for runoff. The

registrant has submitted data to show

that a percentage (15–25%) of the

product is absorbed by the plant,

resulting in that much less product

available to leach into groundwater.

Although the registrant has submitted

data on only 2 crops, beans and

cucumbers, it is likely that the total

amount of thiamethoxam that is

available to leach into groundwater is

less than the amount EPA uses as an

input into its model. Due to a limited

data on the amount absorbed, EPA is

unable to quantify this.

ii. Although the Agency model is

based on aerobic soil half lives, EPA’s

risk assessment for cancer estimate is for

lifetime exposure. Data indicate the

anaerobic aquatic half life for

thiamethoxam is shorter than the

aerobic soil half life and longer than the

aerobic aquatic half life. Although EPA

is unable to predict with a high degree

of certainty about what happens to

thiamethoxam over time in

groundwater, this does provide some

support for an expectation that

concentrations in groundwater will

decline between annual applications.

iii. Shallow groundwater modeling is

not the perfect model for representing

all drinking water from ground water

sources. It is likely to be an overestimate

of most drinking water, which tends to

originate from deeper sources. EPA’s

experience is that the model is

reasonably accurate for shallow

drinking water, but the Agency believes

that it is less accurate for drinking water

from deeper sources.

iv. Currently there is no exposure to

thiamethoxam through drinking water.

The Agency is establishing conditions of

registration for the subject uses of this

document which will include two

prospective ground water studies and a

retrospective monitoring study, so that

the reasonable certainty of no harm

finding will be sustained.

v. The cancer risk from the food uses

alone is 1.0 x 10-6. The dietary risk is

based on residue data derived from the

average of field trials, which were

performed at a higher applied on rate

than were accepted by the EPA. It is not

unusual in the Agency’s experience for

field trial data to be an order of

magnitude above actual monitoring.

Since thiamethoxam is not registered

(for uses other than very recently

registered seed treatments), actual

monitoring data is not available. It is

likely that the actual risk contribution

from food will be much lower than

current data indicate, which would

result in a larger DWLOCcancer. EPA

expects that this refined DWLOCcancer

would be larger than the EECs for the

proposed uses.

Thus, EPA does not expect that the

general population would be exposed to

levels exceeding the DWLOCcancer over a

lifetime.

6. Determination of safety. Based on

these risk assessments, EPA concludes

that there is a reasonable certainty that

no harm will result to the general

population, and to infants and children

from aggregate exposure to

thiamethoxam residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology

(HPLC/UV or MS) 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 international residue

limits for thiamethoxam.

C. Conditions

Registration of the proposed uses will

include the requirement for two

prospective groundwater studies, as

well as monitoring of drinking water in

a number of states selected for high

cropping density and vulnerable soils.

V. Conclusion

Therefore, the tolerances are

established for combined residues of

28396 Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Rules and Regulations

thiamethoxam, 3-[(2-chloro-5-

thiazolyl)methyl]tetrahydro-5-methyl-Nnitro-4H-1,3,5-oxadiazin-4-imine) and

its metabolite (N-(2-chloro-thiazol-5-

ylmethyl)-N ′methyl-N ′′-nitroguanidine, in or on tuberous and corm

vegetables crop subgroup at 0.02 ppm,

fruiting vegetables crop group at 0.25

ppm, tomato paste at 0.80 ppm, cucurbit

vegetables crop group at 0.20 ppm, and

pome fruits crop group at 0.20 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–301132 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 July 23, 2001.

1. Filing the request. Your objection

must specify the specific provisions in

the regulation that you object to, and the

grounds for the objections (40 CFR

178.25). If a hearing is requested, the

objections must include a statement of

the factual issues(s) on which a hearing

is requested, the requestor’s contentions

on such issues, and a summary of any

evidence relied upon by the objector (40

CFR 178.27). Information submitted in

connection with an objection or hearing

request may be claimed confidential by

marking any part or all of that

information as CBI. Information so

marked will not be disclosed except in

accordance with procedures set forth in

40 CFR part 2. A copy of the

information that does not contain CBI

must be submitted for inclusion in the

public record. Information not marked

confidential may be disclosed publicly

by EPA without prior notice.

Mail your written request to: Office of

the Hearing Clerk (1900), Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460. You

may also deliver your request to the

Office of the Hearing Clerk in Rm. C400,

Waterside Mall, 401 M St., SW.,

Washington, DC 20460. The Office of

the Hearing Clerk is open from 8 a.m.

to 4 p.m., Monday through Friday,

excluding legal holidays. The telephone

number for the Office of the Hearing

Clerk is (202) 260–4865.

2. Tolerance fee payment. If you file

an objection or request a hearing, you

must also pay the fee prescribed by 40

CFR 180.33(i) or request a waiver of that

fee pursuant to 40 CFR 180.33(m). You

must mail the fee to: EPA Headquarters

Accounting Operations Branch, Office

of Pesticide Programs, P.O. Box

360277M, Pittsburgh, PA 15251. Please

identify the fee submission by labeling

it ‘‘Tolerance Petition Fees.’’

EPA is authorized to waive any fee

requirement ‘‘when in the judgement of

the Administrator such a waiver or

refund is equitable and not contrary to

the purpose of this subsection.’’ For

additional information regarding the

waiver of these fees, you may contact

James Tompkins by phone at (703) 305–

5697, by e-mail at

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

request for information to Mr. Tompkins

at Registration Division (7505C), Office

of Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

If you would like to request a waiver

of the tolerance objection fees, you must

mail your request for such a waiver to:

James Hollins, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

3. Copies for the Docket. In addition

to filing an objection or hearing request

with the Hearing Clerk as described in

Unit VI.A., you should also send a copy

of your request to the PIRIB for its

inclusion in the official record that is

described in Unit I.B.2. Mail your

copies, identified by docket control

number OPP–301132, to: Public

Information and Records Integrity

Branch, Information Resources and

Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460. In

person or by courier, bring a copy to the

location of the PIRIB described in Unit

I.B.2. You may also send an electronic

copy of your request via e-mail to: oppdocket@epa.gov. Please use an ASCII

file format and avoid the use of special

characters and any form of encryption.

Copies of electronic objections and

hearing requests will also be accepted

on disks in WordPerfect 6.1/8.0 or

ASCII file format. Do not include any

CBI in your electronic copy. You may

also submit an electronic copy of your

request at many Federal Depository

Libraries.

B. When Will the Agency Grant a

Request for a Hearing?

A request for a hearing will be granted

if the Administrator determines that the

material submitted shows the following:

There is a genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

VII. Regulatory Assessment

Requirements

This final rule establishes a tolerance

under FFDCA section 408(d) in

response to a petition submitted to the

Agency. The Office of Management and

Budget (OMB) has exempted these types

of actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). This final rule does

not contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44

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

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA) (Public

Law 104–4). Nor does it require any

special considerations under Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994); or OMB review or any other

Agency action under Executive Order

13045, entitled Protection of Children

from Environmental Health Risks and

Safety Risks (62 FR 19885, April 23,

1997). This action does not involve any

technical standards that would require

Agency consideration of voluntary

consensus standards pursuant to section

12(d) of the National Technology

Transfer and Advancement Act of 1995

(NTTAA), Public Law 104–113, section

12(d) (15 U.S.C. 272 note). Since

Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Rules and Regulations 28397

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 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:May 14, 2001.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 321(q), 346(a) and

371.

2. Section 180.565 is amended by

alphabetically adding commodities to

the table in paragraph (a) to read as

follows:

§ 180.565 Thiamethoxam; tolerances for

resdues.

(a) General. * * *

Commodity Parts per

million

*****

Cucurbit Vegetables Crop

Group .................................... 0.2

Fruiting Vegetables Crop Group 0.25

*****

Pome Fruit Crop Group ............ 0.2

*****

Tomato Paste ........................... 0.80

Tuberous and Corm Vegetables

Crop Subgroup ...................... 0.02

*****

* * * * *

[FR Doc. 01–12899 Filed 5–22–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 272

[FRL–6983–2]

Wisconsin: Clarification of Codification

of Approved State Hazardous Waste

Program for Wisconsin

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Clarification.

SUMMARY: Under the Resource

Conservation and Recovery Act of 1976,

as amended, the Environmental

Protection Agency (EPA) may grant

Final Authorization to States to operate

their hazardous waste management

programs in lieu of the Federal program.

EPA uses part 272 of title 40 of the Code

of Federal Regulations (40 CFR part 272)

to codify its authorization of State

programs. Through codification the

authorized elements of approved State

programs are placed in the Code of

Federal Regulations (CFR). The

codification of State programs is

designed to enhance the public’s ability

to discern the current status of the

approved State program and to better

alert the public to the specific State

regulations that the Federal government

can enforce if necessary. The purpose of

today’s Federal Register document is to

clarify EPA’s codification of

Wisconsin’s authorized hazardous waste

program.

FOR FURTHER INFORMATION CONTACT:

Denise Reape, U.S. EPA Region 5, Waste

Pesticides and Toxics Division, Program

Management Branch (DM–7J), 77 W.

Jackson Blvd., Chicago, IL 60604, Phone

(312) 353–7925.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

This action is directed to the public

in general. This document clarifies

certain requirements of the authorized

RCRA program in the State of Wisconsin

and, therefore, may be of particular

interest to persons who generate, treat,

store, dispose of, or otherwise handle

hazardous waste in the State of

Wisconsin.

B. How Can I Get Additional

Information, Including Copies of This

Document and Other Related

Documents?

Electronically. You may obtain

electronic copies of this document by

going to the listings from the EPA

Internet Home Page at http://

www.epa.gov/. To access this