Federal Register / Vol. 66, No. 246 / Friday, December 21, 2001 / Rules and Regulations 65839

Taking of Private Property

This rule will not effect a taking of

private property or otherwise have

taking implications under Executive

Order 12630, Governmental Actions and

Interference with Constitutionally

Protected Property Rights.

Civil Justice Reform

This rule meets applicable standards

in sections 3(a) and 3(b)(2) of Executive

Order 12988, Civil Justice Reform, to

minimize litigation, eliminate

ambiguity, and reduce burden.

Environmental

The Coast Guard considered the

environmental impact of this rule and

concluded under Figure 2–1, paragraph

34(g) of Commandant Instruction

M16475.1D, this rule is categorically

excluded from further environmental

documentation. A ‘‘Categorical

Exclusion Determination’’ is available in

the docket for inspection or copying

where indicated under ADDRESSES.

Protection of Children

We have analyzed this rule under

Executive Order 13045, Protection of

Children from Environmental Health

Risks and Safety Risks. This rule is not

an economically significant rule and

does not create an environmental risk to

health or risk to safety that may

disproportionately affect children.

Indian Tribal Governments

This rule does not have tribal

implications under Executive Order

13175, Consultation and Coordination

with Indian Tribal Governments,

because it does not have a substantial

direct effect on one or more Indian

tribes, on the relationships between the

Federal Government and Indian tribes,

or on the distribution of power and

responsibilities between the Federal

Government and Indian tribes.

Energy Effects

We have analyzed this rule under

Executive Order 13211, Actions

Concerning Regulations That

Significantly Affect Energy Supply,

Distribution, or Use. We have

determined that it is not a ‘‘significant

energy action’’ under Executive Order

12866 and is not likely to have a

significant adverse effect on the supply,

distribution, or use of energy. It has not

been designated by the Administrator of

the Office of Information and Regulatory

Affairs as a significant energy action.

Therefore, it does not require a

Statement of Energy Effects under

Executive Order 13211.

List of Subjects in 33 CFR Part 165

Harbors, Marine safety, Navigation

(water), Reports and recordkeeping

requirements, Security measures,

Waterways.

For the reasons discussed in the

preamble, the Coast Guard amends 33

CFR part 165, as follows:

PART 165—[AMENDED]

1. The authority citation for part 165

continues to read as follows:

Authority: 33 U.S.C. 1231; 50 U.S.C. 191,

33 CFR 1.05–1(g), 6.04–1, 6.04–6, 160.5; 49

CFR 1.46.

2. A new temporary § 165.T07–139 is

added to read as follows:

§ 165.T07–139 Security Zone; Tampa Bay,

Florida.

(a) Regulated area. The Coast Guard is

establishing temporary fixed security

zones in all waters extending 100 feet

around all bridge supports and rocky

outcroppings at the base of the supports

for the Sunshine Skyway Bridge in

Tampa Bay, located at approximate

position 27° 37′12′′ N Latitude,

82°39′20′′ W Longitude.

(b) Regulations. In accordance with

the general regulations in § 165.33 of

this part, entry into these zones is

prohibited except as authorized by the

Captain of the Port, or his designated

representative. The Captain of the Port

will notify the public via Marine Safety

Radio Broadcast on VHF Marine Band

Radio, Channel 13 and 16 (157.1 MHz).

(c) Dates. This section becomes

effective at 6 p.m. (EST) on December 7,

2001 and will remain in effect until 6

p.m. (EDT) on June 15, 2002.

(d) Authority. The authority for this

section is 33 U.S.C. 1226; 49 CFR 1.46.

Dated: December 4, 2001.

A. L. Thompson, Jr.,

Captain, U. S. Coast Guard, Captain of the

Port.

[FR Doc. 01–31524 Filed 12–20–01; 8:45 am]

BILLING CODE 4910–15–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301184; FRL–6806–7]

RIN 2070–AB78

Fluthiacet-methyl; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

tolerances for residues of fluthiacetmethyl in or on field corn grain, field

corn forage, field corn stover, pop corn

grain, pop corn stover, sweet corn,

kernels plus cob husk removed

(K+CWHR), sweet corn forage, and

sweet corn stover. K-I Chemical, U.S.A.

Inc., 11 Martine Avenue, 9th Floor,

White Plains, New York 10606

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

December 21, 2001. Objections and

requests for hearings, identified by

docket control number OPP–301184,

must be received by EPA on or before

February 19, 2002.

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–301184 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Joanne I. Miller, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave.,

NW.,Washington, DC 20460; telephone

number: (703) 305–6224; and e-mail

address: miller.joanne@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer, or pesticide

manufacturer. Potentially affected

categories and entities may include, but

are not limited to:

Categories NAICS

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

65840 Federal Register / Vol. 66, No. 246 / Friday, December 21, 2001 / Rules and Regulations

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.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–301184. 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 April 14,

1997 (62 FR 18116) (FRL–5599–7), EPA

issued a notice pursuant to section 408

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

amended by the of FQPA 1996 (Public

Law 104–170) announcing the filing of

a pesticide petition (PP) for tolerance by

K-I Chemical U.S.A., Inc., 11 Martine

Avenue, 9th Floor, White Plains, NY

10606. This notice included a summary

of the petition prepared by K-I Chemical

U.S.A. Inc., the registrant. There were

no comments received in response to

the notice of filing. In the Federal

Register of October 6, 1998 (63 FR

53656) (FRL–6033–8), EPA issued a

notice pursuant to the same Acts,

announcing an amendment to the

petition. There were no comments

received in response to the notice of

filing. Addition tolerances for residues

of fluthiacet-methyl per se in or on

cottonseed and cotton gin by products

were requested; however, a revised

Section F to the petition was submitted

in which these tolerances were not

requested.

The petition requested that 40 CFR

180.551 be amended by establishing a

tolerance for residues of the herbicide,

fluthiacet-methyl, acetic acid, [2-chloro4-fluoro-5-[(tetrahydro-3-oxo-1H,3H-

[1,3,4]thiadiazolo[3,4-α]pyridazin-1-

ylidene)amino]phenyl]thio]-methyl

ester), in or on corn, field, grain at 0.010

part per million (ppm); corn, field,

forage at 0.050 ppm; corn, field, stover

at 0.050 ppm; corn, pop, grain at 0.010

ppm; corn, pop, stover at 0.050 ppm;

corn, sweet, forage at 0.050 ppm; corn,

sweet, K + CWHR at 0.010 ppm; and

corn, sweet, stover at 0.050 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) (FRL–5754–7) November 26,

1997.

III. Aggregate Risk Assessment and

Determination of Safety

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

EPA has reviewed the available

scientific data and other relevant

information in support of this action.

EPA has sufficient data to assess the

hazards of and to make a determination

on aggregate exposure, consistent with

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

residues of fluthacet-methyl on corn,

field, grain at 0.010 ppm; corn, field,

forage at 0.050 ppm; corn, field, stover

at 0.050 ppm; corn, pop, grain at 0.010

ppm; corn, pop, stover at 0.050 ppm;

corn, sweet, forage at 0.050 ppm; corn,

sweet, K + CWHR at 0.010 ppm; and

corn, sweet, stover at 0.050 ppm. EPA’s

assessment of exposures and risks

associated with establishing the

tolerance follows.

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered its validity,

completeness, and reliability as well as

the relationship of the results of the

studies to human risk. EPA has also

considered available information

concerning the variability of the

sensitivities of major identifiable

subgroups of consumers, including

infants and children. The nature of the

toxic effects caused by fluthiacet-methyl

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.

Federal Register / Vol. 66, No. 246 / Friday, December 21, 2001 / Rules and Regulations 65841

TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY

Guideline No. Study Type Results

870.3100 90–day oral

Toxicity, rats and mice

Rats:

NOAEL = 6.19 milligrams/kilograms day (mg/kg/day) in

males

6.80 mg/kg/day in females

LOAEL = 216 mg/kg/day in males

249 mg/kg/day in females

Mice:

NOAEL = 1.3 mg/kg/day in males

1.6 mg/kg/day in females

LOAEL = 66 mg/kg/day in males

83 mg/kg/day in females

Based on decreased body weight gains as well as effects

on hematology, clinical chemistry, urinalysis parameters,

liver weights and microscopic pathology in rats; and on

effects on the erythropoietic system and liver in mice.

870.3150 6–week oral toxicity in dogs NOAEL = 236 mg/kg/day in males

77.7 mg/kg/day in females

LOAEL = 709 mg/kg/day in males

232 mg/kg/day in females based on decreased

body weight gain.

870.3200 28–day dermal toxicity in rats NOAEL = 1,000 mg/kg/day, the highest dose tested

(HDT).

870.3700 Prenatal developmental in rats

and rabbits

Maternal in rats:

NOAEL = 1,000 mg/kg/day, HDT

Maternal in rabbits:

NOAEL = 1,000 mg/kg/day, HDT

Developmental in rabbits:

NOAEL = 300 mg/kg/day

Developmental in rabbits:

LOAEL of 1,000 mg/kg/day based on slight non-significant

increased incidence of irregularly shaped sternebrae attributed to a delay in fetal development. (See section D.,

2.)

870.3800 2-generation

Reproduction and fertility effects

Parental/systemic

NOAEL = 1.59 mg/kg/day in males

LOAEL = 31.8 mg/kg/day in males

NOAEL = 1.73 mg/kg/day in females

LOAEL = 35.2 mg/kg/day in females based on reduction in

male body weights/gains and hepatic pathology

Reproductive in males:

NOAEL = 31.8 mg/kg/day

LOAEL =313 mg/kg/day

Reproductive in females:

NOAEL = 37.1 mg/kg/day

LOAEL = 388 mg/kg/day based on decreases in mean litter body weights.

870.4100 Chronic toxicity dogs NOAEL in males = 57.6 mg/kg/day

LOAEL in males = 582 mg/kg/day

NOAEL in females = 30.3 mg/kg/day

LOAEL in females = 145 mg/kg/day

The LOAELs were based on effects observed in the

erythropoietic system and liver.

870.4200 Carcinogenicity rats NOAEL in males = 2.1 mg/kg/day

LOAEL in males = 130 mg/kg/day

NOAEL in females = 2.5 mg/kg/day

LOAEL in females = 154 mg/kg/dayIn males there were

decreased body weight, liver toxicity, pancreatic toxicity

and microcytic anemia. In females there were liver toxicity, uterine toxicity and slight microcytic anemia. In

males only at 130 and 219 mg/kg/day there was respectively, an increase in the trend toward pancreatic exocrine adenomas and pancreatic islet cell adenomas.

65842 Federal Register / Vol. 66, No. 246 / Friday, December 21, 2001 / Rules and Regulations

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

Guideline No. Study Type Results

870.4300 Carcinogenicity mice NOAEL in males and females = 0.1 mg/kg/day

LOAEL in males and females = 0.1 and 1.2 mg/kg/day, respectively, based on non-neoplastic liver findings. In

males, and possibly females, at 10 mg/kg/day for males

and 12 mg/kg/day for females; and at 32 gm/kg/day for

males and 37 mg/kg/day for females, there was an increase in the number of mice with hepatocellular adenomas, carcinomos and or adenomas/carcinomas.

870.1000 Gene mutation Flutiacet-methyl was negative for mutagenic/genotoxic effects in bacterial or cultured mammalian cells and did

not cause DNA damage in bacterial or primary rat

hepatocytes.

870.5375 Cytogenetics In vitro cytogenetic assays performed with two different

mammalian cell lines demonstrated that fluthiacet-methyl

is clastogenic both in the presence and absence of S9

activation.

870 Other effects Flutiacet-methyl was negative for micronuclei induction in

mouse bone marrow, a significant increase in

micronuclei was seen in stimulated rat liver cells following in vivo exposure.

870.6200 Acute neurotoxicity screening battery in

rats

NOAEL = 2,000 mg/kg/day, with no effects at HDT

870.6200 Subchronic neurotoxicity screening battery in ratsNOAEL in males = 0.576 mg/kg/day (systemic)

LOAEL in males = 556 mg/kg/day based on decreased

body weight and food consumption

NOAEL in females = 1,345 mg/kg/day (HDT) (systemic)

NOAEL in males = 1,128 mg/kg/day (neurotoxicity)

NOAEL in females = 1,345 mg/kg/day (neurotoxicity)

870.7485 Metabolism and pharmaco-kinetics in

rats

Fluthiacet-methyl was absorbed rapidly at both low and

high dosages in both male and female rats. Repeated

oral dosing had no effect on extent of absorption. Tissue

levels of radio active fluthiacet-methyl in single and repeated low dose groups did not exceed 0.018 ppm in

any tissue. At the single high dose, female rats showed

higher levels of radioactivity in tissues than males except for muscle, brain, fat and plasma. Excretion in

males was predominantly in feces for all dose groups,

with between 67 to 87% of administered radioactivity excreted by this route. In females, the percentage of administered radioactivity in urine across all dose groups

40 to 48% was approximately equivalent to the percent

excreted in feces, 39 to 52%. The greater fecal excretion in males was based on a greater percentage excretion in bile for males, 37% vs. females 19%.

870.7600 Dermal penetration No dermal penetration studies were submitted.

Special studies There were no required special studies

B. Toxicological Endpoints

The dose at which 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 LOAEL

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

Federal Register / Vol. 66, No. 246 / Friday, December 21, 2001 / Rules and Regulations 65843

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 fluthiacet-methyl used for human

risk assessment is shown in the

following Table 2:

TABLE 2. —SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUTHIACET-METHYL FOR USE IN HUMAN RISK

ASSESSMENT.

Exposure Scenario Dose (mg/kg/day) Endpoint Study

Acute Dietary None No appropriate endpoint attributable to a single

dose (exposure) was

identified in oral toxicity

studies. Therefore, an

acute reference dose

(RfD) was not established. Thus, an acute

exposure/risk assessment was not conducted.

None

NOT REQUIRED

Chronic Dietary

General population

NOAEL = 0.1 mg/kg/day Non-neoplastic liver findings (increase in absolute and relative liver

weights, fatty changes,

chronic inflammation,

karyomegaly, single cell

necrosis and ceroid/lipofuscin pigmentation).

18-month carcinogenicity in the mouse

UF = 100

FQPA SF = 1

Chronic RfD = 0.001 mg/

kg/day

Chronic PAD = 0.001 mg/

kg/day

Short-term and intermediateterm (dermal)None No dermal or systemic toxicity was seen at the

limit-dose following repeated dermal applications to rats.

28–day dermal in the rat

Long-term (dermal) see footnote

1 below table

NOAEL = 0.1 mg/kg/day Non-neoplastic liver findings (increase in absolute and relative liver

weights, fatty changes,

chronic inflammation,

karyomegaly, single cell

necrosis and ceroid/lipofuscin pigmentation).

18–month carcinogenicity in the mouse

Inhalation (Any time period) None The LC50 for males and females was >5,048 ± 225

mg/m3 (>5.0 mg/L).

Based on the low acute

toxicity (Toxicity Category 4), the composition

of the end-use product

(5.36%) and the application rate (0.0089 lb ai/

acre/season or 4.0 g ai/

acre/season), an inhalation exposure/risk assessment was not conducted.

None

65844 Federal Register / Vol. 66, No. 246 / Friday, December 21, 2001 / Rules and Regulations

TABLE 2. —SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUTHIACET-METHYL FOR USE IN HUMAN RISK

ASSESSMENT.—Continued

Exposure Scenario Dose (mg/kg/day) Endpoint Study

Cancer (Chronic) Q1

* = 2.07E-1

(mg/kg/day)-1

(In human equivalents)

The HED, CARC (HED

Cancer Assessment Review Committee) recommended a linear lowdose approach (Q1

*) for

human risk characterization and determined that

extrapolation should be

based on the combined

hepatocellular tumors

(adenomas and carcinomas) in male mice.

78–week carcinogenicity in the mouse

1= Long-term dermal Since an oral study was selected and there is no dermal absorption study, a 100% dermal absorption factor (default

value) was used.

C. Exposure Assessment

1. Dietary exposure from food and

feed uses. Tolerances have been

established (40 CFR 180.551) for the

residues of fluthiacet-methyl, in or on a

variety of raw agricultural commodities.

There are presently no tolerances

established for meat, milk, poultry and

eggs. Based upon the results of a

ruminant feeding study and a goat

metabolism study, this Agency

concluded that there is no reasonable

expectation of finite residues in

ruminant tissues and milk. Based upon

the results of a poultry metabolism

study, fluthiacet-methyl and its

metabolite (CGA–300403) are unlikely

to occur in poultry or eggs. Risk

assessments were conducted by EPA to

assess dietary exposures from fluthiacetmethyl in food as follows:

i. Acute exposure. Acute dietary risk

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

indicated the possibility of an effect of

concern occurring as a result of a 1–day

or single exposure. There were no

toxicological effects that could be

attributed to a single oral exposure

(dose) in an appropriate toxicological

study. Thus, an acute exposure/risk

assessment was not conducted for

fluthiacet-methyl.

ii. Chronic exposure. Percent crop

treated (PCT), anticipated market share

percentages and tolerance level residues

were used.

A chronic reference dose (RfD) (0.001

mg/kg/day) was identified for fluthiacetmethyl, based on non-neoplastic liver

findings (increase in absolute and

relative liver weights, fatty changes,

chronic inflammation, karyomegaly,

single cell necrosis and ceroid/

lipofuscin pigmentation). The chronic

PAD is the same as the chronic RfD

since the FQPA factor was reduced to

1X. The chronic PAD was used to assess

chronic risk.

EPA’s Office of Pesticide Programs

(OPP) Health Effects Division used

Dietary Exposure Evaluation Model

(DEEMTM), version 7.075) software for

conducting a chronic dietary (food)

exposure analysis. DEEM TM is a dietary

exposure analysis system developed by

Novigen Sciences, Inc. that is used to

estimate exposure to pesticide residues

in foods comprising the diets of the U.S.

population, including population

subgroups. DEEMTM contains food

consumption data as reported by

respondents in the USDA Continuing

Surveys of Food Intake by Individuals

conducted in 1989–1992.

A Tier 2 chronic DEEMTM analysis

was performed. The assumptions of this

Tier 2 analysis were tolerance level

residues and estimates of PCT for

soybeans and projected market-share for

corn commodities. The following

tolerance levels were used in the

analysis: soybeans at 0.01 ppm, sweet

corn at 0.01 parts per million (ppm),

pop corn at 0.01 ppm, and corn grain

(field corn) at 0.01 ppm. These values

were also used for corresponding

processed commodities since processing

studies for soybeans and field corn

showed no concentration of residues

into processed commodities. Thus,

default concentration factors for corn

grain, bran; corn grain, endosperm; corn

grain, oil; soybean, other; soybeans,

sprouted seeds; soybeans, flour

(defatted, low fat, and full fat); soybean,

oil; and soybean, protein isolate were

set to 1X. DEEMTM default processing

factors for corn grain/sugar/hfcs (1.5X),

and corn grain/sugar-molasses (1.5X)

were retained as processing data for

these commodities are not available. A

PCT value of 1% was used for soybeans

and a projected market share value of

1% was used for all types of corn. These

estimates of PCT/projected market share

were derived based on Agency analysis

of information on weed-pests for the use

sites.

The chronic dietary exposure (food

only) to fluthiacet-methyl for some

population subgroups are presented in

Table 3. The resulting dietary food

exposures occupy <1% of the Chronic

PAD for all population subgroups

included in the analysis. The results of

this dietary exposure analysis should be

viewed as partially refined. Refinements

such as use of anticipated residue

values may yield even lower estimates

of chronic dietary exposure.

TABLE 3.—SUMMARY: CHRONIC DIETARY EXPOSURE ANALYSIS BY

DEEM (TIER 2)

Population

Subgroup1

Exposure

(mg/kg/day)

% of Chronic PAD2

U.S. population (total)<0.000001 <1.0

All Infants (<1

year)

0.000001 <1.0

Children (1–6

years)

<0.000001 <1.0

Children (7–12

years)

<0.000001 <1.0

Males (20+

years)

<0.000001 <1.0

Females (13–

50 years)

<0.000001 <1.0

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

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

children; and, (3) the most highly exposed of

the adult females and males subgroups (in

this case, females, 13 to 50 years and males

20+ years). 2 Percent chronic PAD = (exposure ÷ chronic PAD) x 100%.

Note: There are no other subgroup(s) (other

than All Infants) for which the percentage of

the Chronic PAD occupied is greater than that

occupied by the subgroup U. S. population

(total).

Federal Register / Vol. 66, No. 246 / Friday, December 21, 2001 / Rules and Regulations 65845

iii. Cancer. Fluthiacet-methyl has

been classified as ‘‘likely to be a human

carcinogen’’ by EPA. The Office of

Pesticide Programs, Heath Effects

Division, Cancer Assessment Review

Committee recommended a linear lowdose approach (Q1

*) for human risk

assessment. The Q1

* is 0.207 (mg/kg/

day)–1 in human equivalents and is

based upon the combined

hepatocellular tumors (adenomas and

carcinomas) in male mice.

EPA conducted a cancer assessment

analysis (food) using DEEM software

and Tier 2 chronic dietary exposure

assumptions. The assumptions of this

Tier 2 chronic dietary analysis are as

specified above.

The cancer risk estimate (food only)

for the U.S. population (total) is 3.93 x

10-8. This risk estimate translates to a

dietary exposure of 1.90 x 10-7 mg/kg/

day. This dietary exposure value was

back-calculated based upon the cancer

risk estimate and the Q1

*. As cancer risk

= Exposure x Q1 * Thus, Exposure =

cancer risk estimate/ Q1 * or Exposure

= 3.93 x 10-8/0.207.

iv. Anticipated residue and PCT

information. Anticipated residues

estimates were not used in the exposure

analysis. Tolerance levels were used

and a projected market share estimate

was used as described in the chronic

exposure section above.

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 PCT as required by

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

registrants to submit data on PCT.

The Agency used PCT information as

follows: Percent projected market share:

Corn, 1% and soybeans, 1%. Currently

the largest market share for a pesticide

for control of velvetleaf in corn or cotton

is less than 20%. While the Agency does

not expect the PCT to exceed 1% for

corn or soybeans, it would be highly

unlikely that the PCT approach the 20%

share. EPA has determined that if PCT

was to reach 20% there is still a

reasonable certainty that no harm will

result to the general population, and to

infants and children from aggregate

exposure to fluthiacet-methyl residues.

The Agency believes that the three

conditions listed above have been met.

With respect to Condition 1, PCT

estimates are derived from Federal and

private market survey data, which are

reliable and have a valid basis. EPA uses

a weighted average PCT for chronic

dietary exposure estimates. This

weighted average PCT figure is derived

by averaging State-level data for a

period of up to 10 years, and weighting

for the more robust and recent data. A

weighted average of the PCT reasonably

represents a person’s dietary exposure

over a lifetime, and is unlikely to

underestimate exposure to an individual

because of the fact that pesticide use

patterns (both regionally and nationally)

tend to change continuously over time,

such that an individual is unlikely to be

exposed to more than the average PCT

over a lifetime. EPA believes the PCT

used in this analysis is reasonable based

on factors used in the analysis; in

particular, the number of acres of corn

and soybeans currently treated for the

control of the weed pest, velvetleaf, the

primary target weed pest for which

fluthiacet-methyl will be used. This

analysis also included competing

currently registered herbicides for this

market. EPA estimates that currently

about 25 million acres of soybeans and

50 million acres of corn are treated for

control of velvetleaf. Corn acres are

treated with 41 different herbicidal

active ingredients (a.i.), and soybeans

acres are treated with 34 different

herbicidal a.i.. For acute dietary

exposure estimates, EPA uses an

estimated maximum PCT. The exposure

estimates resulting from this approach

reasonably represent the highest levels

to which an individual could be

exposed, and are unlikely to

underestimate an individual’s acute

dietary exposure. The Agency is

reasonably certain that the percentage of

the food treated is not likely to be an

underestimation. 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 allows the

Agency to be reasonably certain that no

regional population is exposed to

residue levels higher than those

estimated by the Agency. Other than the

data available through national food

consumption surveys, EPA does not

have available information on the

regional consumption of food to which

fluthiacet-methyl may be applied in a

particular area.

1. Dietary exposure 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

fluthiacet-methyl. Therefore, the Agency

is presently relying on computergenerated estimated environmental

concentrations (EECs). The PRZM/

EXAMS Index Reservoir (IR) model was

used to generate EECs for surface water

and the SCI-GROW2 (an empirical

model based upon actual monitoring

data collected for a number of pesticides

that serve as benchmarks) was used to

predict 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 determining that

pesticides residues (and its metabolites)

in water are not of concern.

For any given pesticide, the SCIGROW2 model generates a single EEC

value of pesticide concentration in

ground water. That EEC is used in

assessments of both acute and chronic

dietary risk. It is not unusual for the

ground water EEC to be significantly

lower than the surface water EECs. The

PRZM/EXAMS IR model generates

several time-based EECs of pesticide

concentration in surface water for acute

exposure (upper 10th percentile of peak

values), non-cancer chronic exposure

(upper 10th percentile of 90–day values),

and cancer exposure (mean annual

value).

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.

65846 Federal Register / Vol. 66, No. 246 / Friday, December 21, 2001 / Rules and Regulations

EPA, OPP, HED back-calculates

DWLOCs by a two-step process:

exposure [food + residential (if

applicable)] is subtracted from the PAD

to obtain the maximum acceptable

exposure allowed in drinking water;

DWLOCs are then calculated using that

value and HED default body weight and

drinking water consumption figures. In

assessing human health risk, DWLOCs

are compared to EECs. When EECs are

less than DWLOCs, HED considers the

aggregate risk from [food + water +

residential (if applicable) exposures] to

be acceptable.

2. Environmental profile. In soil,

fluthiacet-methyl and its metabolites are

considered to be mobile and persistent

(effective or combined aerobic soil halflife of 305 days). The uncertainty of this

half-life is large as indicated by a 95%

confidence range of roughly 200 to

1,100 days. Due to the large uncertainty

a soil half-life of 915 days was used in

the models. Fluthiacet-methyl is

expected to be a ground and surface

water contaminant.

EPA, HED, Metabolism Assessment

Review Committee (MARC) determined

that the residues of concern for risk

assessment purposes in water are

residues that comprised greater than or

equal to 10% of the total radioactive

residues in the environmental fate

studies. These residues include, but are

not limited to, CGA–300402, CGA–

300404, CGA–330057, component E,

CGA–300403, CGA–327066, CGA–

327067, CGA–330059, A-CFPSA, and

ACA-CFPSA.

3. Estimated environmental

concentrations (EECs). The modeling

results below are based on the combined

concentrations of six chemicals. These

chemicals are the parent compound and

metabolites CGA–300402, CGA–300403,

CGA–327066, CGA–327067, and ACFPSA. The modeling was conducted

based on the environmental profile and

two applications at the rate of 0.0045 lbs

ai/A (or a seasonal rate of 0.009 lbs ai/

A).

The EECs are shown in Table 4.

TABLE 4.—EFED ESTIMATED ENVIRONMENTAL CONCENTRATIONS

(EECS)

SCI-GROW2 (μg/L)1 PRZM/EXAMS IR

Model (μg/L)

0.08

(acute and chronic)

0.8

(for acute exposure)

0.5

(for chronic (noncancer) exposure)

0.06

(for cancer exposure)

1 μg/L = parts per billion or ppb.

The Agency lacks sufficient

monitoring exposure data to complete a

comprehensive dietary exposure

analysis and risk assessment for

fluthiacet-methyl 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 fluthiacetmethyl.

The Agency uses the First Index

Reservoir Screening Tool (FIRST) or the

Pesticide Root Zone/Exposure Analysis

Modeling System (PRZM/EXAMS), to

produce estimates of pesticide

concentrations in an index reservoir.

The SCI-GROW model is used to predict

pesticide concentrations in shallow

ground water. For a screening-level

assessment for surface water EPA will

use FIRST (a tier 1 model) before using

PRZM/EXAMS (a tier 2 model). The

FIRST model is a subset of the PRZM/

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

While both FIRST and PRZM/EXAMS

incorporate an index reservoir

environment, the PRZM/EXAMS model

includes a percent crop (PC) area factor

as an adjustment to account for the

maximum PC 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.

As 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 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. Because DWLOCs

address total aggregate exposure to

fluthiacet-methyl they are further

discussed in the aggregate risk sections

below.

Based on the PRZM/EXAMS and SCIGROW 2 models the estimated

environmental concentrations (EECs) of

fluthiacet-methyl for acute exposures

are estimated to be 0.8 ppb for surface

water and 0.08 ppb for ground water.

The EECs for chronic exposures (noncancer) are estimated to be 0.5 ppb for

surface water and 0.08 ppb for ground

water. The EEC for chronic (cancer)

exposures are estimated to be 0.08 ppb

for ground water and 0.06 ppb for

surface water.

4. 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).

Fluthiacet-methyl is not registered for

use on any sites that would result in

residential exposure.

5. 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

fluthiacet-methyl 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, fluthiacetmethyl 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 fluthiacet-methyl 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

Federal Register / Vol. 66, No. 246 / Friday, December 21, 2001 / Rules and Regulations 65847

Bifenthrin Pesticide Tolerances (62 FR

62961, November 26, 1997).

D. Safety Factor for Infants and

Children

1. In general. FFDCA section 408

provides that EPA shall apply an

additional tenfold margin of safety for

infants and children in the case of

threshold effects to account for prenatal

and postnatal toxicity and the

completeness of the data base on

toxicity and exposure unless EPA

determines that a different margin of

safety will be safe for infants and

children. Margins of safety are

incorporated into EPA risk assessments

either directly through use of a margin

of exposure (MOE) analysis or through

using uncertainty (safety) factors in

calculating a dose level that poses no

appreciable risk to humans.

2. Prenatal and postnatal sensitivity.

There was no indication of quantitative

or qualitative increased susceptibility of

rats or rabbits to in utero and/or

prenatal/postnatal exposure to

fluthiacet-mthyl. In rabbits, in utero

exposure did not result in maternal

toxicity at 1,000 mg/kg/day.

Developmental toxicity, however, was

seen at this dose characterized as an

increase in irregular sternebrae (a

variation which is reversible). The

occurrence of developmental toxicity at

which no maternal toxicity was noted

indicates an apparent increase in

susceptibility. The Office of Pesticide

Program’s Hazard Identification

Assessment Review Committee

(HIARC), however, determined that the

apparent susceptibility is not

convincing because of the equivocal

nature of the effect based on: (1) The

increased incidence of irregular

sternebrae was not statistically

significant when compared to

concurrent controls; (2) the increase

occurred at the Limit-Dose (1,000 mg/

kg/day; (3) it was the only anomaly seen

(i.e., a single variation); (4) the dose

response was not strong because there

was only a small increase in the litter

incidence between the low- (5 mg/kg/

day) and the high-dose (1,000 mg/kg/

day), with the mid- and high-dose

groups having 8 litters with this

variation;, and (5) this endpoint is

appropriate to establish a LOAEL and

not appropriate for risk assessments.

Based on these factors, the HIARC

concluded that there is no increased

susceptibility in the rabbit study.

Therefore, the 10X FQPA safety factor to

ensure the protection of infants and

children was not applied in the risk

assessments.

3. Conclusion. There is a complete

toxicity data base for fluthiacet-methyl

and exposure data are complete or are

estimated based on data that reasonably

accounts for potential exposures. The

10X FQPA safety factor to protect

infants and children was removed based

on the lack of increased susceptibility of

rats or rabbits to in utero and/or

postnatal exposure to this chemical.

E. Aggregate Risks and Determination of

Safety

To estimate total aggregate exposure

to a pesticide from food, drinking water,

and residential uses, the Agency

calculates DWLOCs which are used as a

point of comparison against the model

estimates of a pesticide’s concentration

in water (EECs). DWLOC values are not

regulatory standards for drinking water.

DWLOCs are theoretical upper limits on

a pesticide’s concentration in drinking

water in light of total aggregate exposure

to a pesticide in food and residential

uses. In calculating a DWLOC, the

Agency determines how much of the

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

available for exposure through drinking

water [e.g., allowable chronic water

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

food + residential exposure)]. This

allowable exposure through drinking

water is used to calculate a DWLOC.

A DWLOC will vary depending on the

toxic endpoint, drinking water

consumption, and body weights. Default

body weights and consumption values

as used by the USEPA Office of Water

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

ground water are less than the

calculated DWLOCs, OPP concludes

with reasonable certainty that exposures

to the pesticide in drinking water (when

considered along with other sources of

exposure for which OPP has reliable

data) would not result in unacceptable

levels of aggregate human health risk at

this time. Because OPP considers the

aggregate risk resulting from multiple

exposure pathways associated with a

pesticide’s uses, levels of comparison in

drinking water may vary as those uses

change. If new uses are added in the

future, OPP will reassess the potential

impacts of residues of the pesticide in

drinking water as a part of the aggregate

risk assessment process.

1. Acute risk. An acute dietary

endpoint for fluthiacet-methyl has not

been identified; therefore, fluthiacetmethyl is not expected to pose an acute

risk.

2. Chronic risk. Using the exposure

assumptions described in this unit for

chronic exposure, EPA has concluded

that exposure to fluthiacet-methyl from

food will utilize <1% of the cPAD for

the U.S. population, <1% of the cPAD

for all infants <1 year and <1% of the

cPAD for all children. There are no

residential uses for fluthiacet-methyl

that result in chronic residential

exposure to fluthiacet-methyl. Based the

use pattern, chronic residential

exposure to residues of fluthiacetmethyl is not expected. In addition,

there is potential for chronic dietary

exposure to fluthiacet-methyl in

drinking water. After calculating

DWLOCs and comparing them to the

EECs for surface and ground water, EPA

does not expect the aggregate exposure

to exceed 100% of the cPAD, as shown

in the following Table 5:

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

Population Subgroup %cPAD

(Food)

Surface

Water EEC

(ppb)

Ground

Water EEC

(ppb)

Chronic

DWLOC

(ppb)

U.S. population <1.0 0.5 0.08 35

All infant <1.0 0.5 0.08 1.0

Females (13–20 years) <1.0 0.5 0.08 30

65848 Federal Register / Vol. 66, No. 246 / Friday, December 21, 2001 / Rules and Regulations

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

Population Subgroup %cPAD

(Food)

Surface

Water EEC

(ppb)

Ground

Water EEC

(ppb)

Chronic

DWLOC

(ppb)

Males (20 + years) <1.0 0.5 0.08 35

Chronic PAD (cPAD) in mg/kg/day is 0.001 for all population subgroups.

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).

Fluthiacet-methyl is not registered for

use on any sites that would result in

residential exposure. Therefore, the

aggregate risk is the sum of the risk from

food and water, which do not exceed

the Agency’s level of concern.

4. Intermediate-term risk.

Intermediate-term aggregate exposure

takes into account residential exposure

plus chronic exposure to food and water

(considered to be a background

exposure level).

Fluthiacet-methyl is not registered for

use on any sites that would result in

residential exposure. Therefore, the

aggregate risk is the sum of the risk from

food and water, which do not exceed

the Agency’s level of concern.

5. Aggregate cancer risk for U.S.

population. Fluthiacet-methyl has been

classified as ‘‘likely to be a human

carcinogen’’ based upon the combined

hepatocellular tumors (adenomas and

carcinomas in male mice.

6. Cancer aggregate risk conclusions.

As summarized previously, the cancer

risk estimate (food only) for the U.S.

population (total) is 3.93 x 10-8. This

risk estimate translates to an exposure of

1.90 x 10-7 mg/kg/day. The results of

this dietary exposure analysis should be

viewed as partially refined (health

protective). Refinements such as use of

anticipated residue values may yield

even lower estimates of cancer

exposure.

The EECs provided by EFED for

assessing cancer risk are 0.08 μg/L (for

ground water, based on SCI-GROW2)

and 0.06 μg/L (for surface water, based

on PRZM/EXAMS IR modeling). The

back-calculated DWLOC for assessing

cancer aggregate dietary risk is 0.17 μg/

L for the U.S. population (total).

The SCI-GROW2 and PRZM/EXAMS

cancer EECs are less than the Agency’s

level of comparison for fluthiacetmethyl residues in drinking water as a

contribution to chronic (cancer)

aggregate exposure. HED thus concludes

with reasonable certainty that residues

of fluthiacet-methyl in drinking water

will not contribute significantly to the

aggregate cancer human health risk and

that the chronic (cancer) aggregate

exposure from fluthiacet-methyl

residues in food and drinking water will

not exceed the Agency’s level of

concern (1X 106) for the U.S.

population. EPA generally has no

concern for exposures below which

result in cancer risks in the range of 1

x 10-6, 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, very conservative, and

protective of human health.

7. 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 fluthiacetmethyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology

(Method AG–603B, MRID No. 442345–

02), gas-liquid chromotography with a

nitrogen/phosphorus detector, is

available to enforce the tolerances for

fluthiacet-methyl in or on corn and

soybean commodities. The method may

be requested from: Calvin Furlow,

PRRIB, IRSD (7502C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW,

Washington, DC 20460; telephone

number: (703) 305–5229; e-mail address:

furlow.calvin@epa.gov.

B. International Residue Limits

There are no Codex Alimentarius

Commission (Codex), Canadian, or

Mexican Maximum Residue Levels

(MRLs) for fluthiacet-methyl at this

time.

C. Conditions

Conditions for registration under the

Federal Insecticide, Fungicide and

Rodenticide Act (FIFRA) will include

Agency monitoring for PCT as

addressed within this Final Rule.

V. Conclusion

Tolerances are established for

residues of fluthiacet-methyl in or on

corn. field, grain at 0.010 ppm; corn,

field, forage, at 0.050 ppm; corn, field,

stover at 0.050 ppm; corn, pop, grain at

0.010 ppm; corn, pop, stover at 0.050

ppm; corn, sweet, stover at 0.050 ppm;

corn, sweet, forage at 0.050 ppm; and

corn, sweet, K + CWHR at 0.010 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–301184 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 February 19, 2002.

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

Federal Register / Vol. 66, No. 246 / Friday, December 21, 2001 / Rules and Regulations 65849

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–301184, 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). Because this rule has

been exempted from review under

Executive Order 12866 due to its lack of

significance, this rule is not subject to

Executive Order 13211, Actions

Concerning Regulations That

Significantly Affect Energy Supply,

Distribution, or Use (66 FR 28355, May

22, 2001). 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 in

Executive Order 13084, entitled

Consultation and Coordination with

Indian Tribal Governments (63 FR

27655, May 19, 1998); special

considerations under Executive Order

12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994); or OMB review or any Agency

action under Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

Risks (62 FR 19885, April 23, 1997).

This action does not involve any

technical standards that would require

Agency consideration of voluntary

consensus standards pursuant to section

12(d) of the National Technology

Transfer and Advancement Act of 1995

(NTTAA), Public Law 104–113, section

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

tolerances and exemptions that are

established on the basis of a petition

under FFDCA section 408(d), such as

the tolerance in this final rule, do not

require the issuance of a proposed rule,

the requirements of the Regulatory

Flexibility Act (RFA) (5 U.S.C. 601 et

seq.) do not apply. In addition, the

Agency has determined that this action

will not have a substantial direct effect

on States, on the relationship between

the national government and the States,

or on the distribution of power and

responsibilities among the various

levels of government, as specified in

Executive Order 13132, entitled

Federalism (64 FR 43255, August 10,

1999). Executive Order 13132 requires

EPA to develop an accountable process

to ensure ‘‘meaningful and timely input

by State and local officials in the

development of regulatory policies that

have federalism implications.’’ ‘‘Policies

that have federalism implications’’ is

defined in the Executive Order to

include regulations that have ‘‘

substantial direct effects on the States,

on the relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government.’’ This final rule

directly regulates growers, food

processors, food handlers and food

retailers, not States. This action does not

alter the relationships or distribution of

power and responsibilities established

by Congress in the preemption

provisions of FFDCA section 408(n)(4).

For these same reasons, the Agency has

determined that this rule does not have

any ‘‘tribal implications’’ as described

in Executive Order 13175, entitled

Consultation and Coordination with

Indian Tribal Governments (65 FR

67249, November 6, 2000). Executive

Order 13175, requires EPA to develop

an accountable process to ensure

‘‘meaningful and timely input by tribal

officials in the development of

65850 Federal Register / Vol. 66, No. 246 / Friday, December 21, 2001 / Rules and Regulations

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, or on the

distribution of power and

responsibilities between the Federal

government and Indian tribes.’’ This

rule will not have substantial direct

effects on tribal governments, on the

relationship between the Federal

government and Indian tribes, or on the

distribution of power and

responsibilities between the Federal

government and Indian tribes, as

specified in Executive Order 13175.

Thus, Executive Order 13175 does not

apply to this rule.

VIII. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit a

report containing this rule and other

required information to the U.S. Senate,

the U.S. House of Representatives, and

the Comptroller General of the United

States prior to publication of this final

rule in the Federal Register. This final

rule is not a ‘‘major rule’’ as defined by

5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and record keeping

requirements.

Dated: December 8, 2001.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180— [AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

371.

2. Section 180.551 is amended by

alphabetically adding commodities to

the table in paragraph (a) to read as

follows:

§ 180.551 Fluthiacet-methyl; tolerances for

residues.

(a) General. * * *

Commodity Parts per million

Corn, field, forage 0.050

Corn, field, grain 0.010

Corn, field, stover 0.050

Corn, pop, grain 0.010

Corn, pop, stover 0.050

Corn, sweet, forage 0.050

Corn, sweet, (K +

CWHR)

0.010

Corn, sweet, stover 0.050

*****

* * * * *

[FR Doc. 01–31497 Filed 12–20–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301196; FRL–6811–6]

RIN 2070–AB78

Sodium thiosulfate; 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 sodium

thiosulfate when used as an inert

ingredient (dechlorinator) in or on

growing crops, or when applied to raw

agricultural commodities after harvest.

Eden Bioscience submitted a petition to

EPA under the Federal Food, Drug, and

Cosmetic Act, as amended by the Food

Quality Protection Act of 1996

requesting an exemption from the

requirement of a tolerance. This

regulation eliminates the need to

establish a maximum permissible level

for residues of sodium thiosulfate.

DATES: This regulation is effective

December 21, 2001. Objections and

requests for hearings, identified by

docket control number OPP–301196,

must be received by EPA on or before

February 19, 2002.

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 VIII. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301196 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Kathryn Boyle, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 305–6304; and e-mail

address: boyle.kathryn@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer, or pesticide

manufacturer. Potentially affected

categories and entities may include, but

are not limited to:

Categories NAICS

codes

Examples of potentially affected entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations,’’ ‘‘Regulations

and Proposed Rules,’’ and then look up

the entry for this document under the

‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/. A frequently

updated electronic version of 40 CFR