66786 Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Rules and Regulations

Dated: December 14, 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 180.479 is amended by

adding text to paragraph (b) to read as

follows:

§ 180.479 Halosulfuron; tolerances for

residues.

* * * * *

(b) Section 18 emergency exemptions.

A time-limited tolerance is established

for halosulfuron-methyl, methyl 5-[(4,6-

dimethoxy-2-pyrimidinyl)amino]

carbonylaminosulfonyl-3-chloro-1-

methyl-1H-pyrazole-4-carboxylate, in or

on asparagus in connection with use of

the pesticide under a section 18

exemption granted by EPA. The timelimited tolerance will expire on the date

specified in the following table.

Commodity Parts per million Expiration/revocation date

Asparagus .................................................................................................................................................... 2.0 12/31/03

* * * * *

[FR Doc. 01–31800 Filed 12–26–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301180; FRL–6804–1]

RIN 2070–AB78

Pymetrozine; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

tolerances for residues of pymetrozine

1,2,4-triazin-3(2H)-one,4,5-dihydro-6-

methyl-4-[(3-pyridinylmethylene)

amino] in or on cotton seed, undelinted

at 0.3 parts per million (ppm); cotton

gin byproducts at 2.0 ppm; fruiting

vegetables at 0.2 ppm; cucurbit

vegetables at 0.1 ppm; leafy vegetables

(except Brassica) at 0.6 ppm; head and

stem Brassica vegetables at 0.5 ppm;

leafy Brassica and turnip greens at 0.25

ppm; hops (dried) at 6.0 ppm; and

pecans at 0.02 ppm. Syngenta Crop

Protection 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

December 27, 2001. Objections and

requests for hearings, identified by

docket control number OPP–301180,

must be received by EPA on or before

February 25, 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–301180 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Daniel Peacock, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 305–5407; and e-mail

address: peacock.dan@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer, or pesticide

manufacturer. Potentially affected

categories and entities may include, but

are not limited to:

Categories NAICS Examples of Potentially Affected Entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations’’, ‘‘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

theFederal Register listings at http://

www.epa.gov/fedrgstr/. A frequently

updated electronic version of 40 CFR

part 180 is available at http://

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

cfrhtml_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–301180. 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 July 19,

2001 (66 FR 37677–37681 (FRL–6793–

9), EPA issued a notice pursuant to

section 408 of the Federal Food, Drug,

and Cosmetic Act (FFDCA), 21 U.S.C.

Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Rules and Regulations 66787

346a as amended by the Food Quality

Protection Act of 1996 (FQPA) (Public

Law 104–170) announcing the filing of

a pesticide petition (PP) for tolerance

by, Syngenta Crop Protection of

Greensboro, North Carolina 27419. This

notice included a summary of the

petition prepared by Syngenta, the

registrant. There were no comments

received in response to the notice of

filing.

The petition requested that 40 CFR

180.556 be amended by establishing a

tolerance for residues of the insecticide

pymetrozine 1,2,4-triazin-3(2H)-one,4,5-

dihydro-6- methyl-4-[(3-

pyridinylmethylene) amino] in or on

cotton seed, undelinted at 0.4 ppm;

cotton gin byproducts at 3.0 ppm;

fruiting vegetables at 0.2 ppm; cucurbit

vegetables at 0.1 ppm; leafy vegetables

(except Brassica) at 6.0 ppm; head and

stem Brassica vegetables at 2.0 ppm;

leafy Brassica greens at 5.0 ppm; hops

(dried) at 5.0 ppm; and pecans at 0.02

ppm.

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

allows EPA to establish a tolerance (the

legal limit for a pesticide chemical

residue in or on a food) only if EPA

determines that the tolerance is ‘‘safe.’’

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

mean that ‘‘there is a reasonable

certainty that no harm will result from

aggregate exposure to the pesticide

chemical residue, including all

anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

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

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue....’’

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. For

further discussion of the regulatory

requirements of section 408 and a

complete description of the risk

assessment process, see the final rule on

Bifenthrin Pesticide Tolerances (62 FR

62961, November 26, 1997) (FRL–5754–

7).

III. Aggregate Risk Assessment and

Determination of Safety

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

EPA has reviewed the available

scientific data and other relevant

information in support of this action.

EPA has sufficient data to assess the

hazards of and to make a determination

on aggregate exposure, consistent with

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

residues of pymetrozine in or on cotton

seed, undelinted at 0.3 ppm; cotton gin

byproducts at 2.0 ppm; fruiting

vegetables at 0.2 ppm; cucurbit

vegetables at 0.1 ppm; leafy vegetables

(except Brassica) at 0.6 ppm; head and

stem Brassica vegetables at 0.5 ppm;

leafy Brassica and turnip greens at 0.25

ppm; hops (dried) at 6.0 ppm; and

pecans at 0.02 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 pymetrozine are

discussed in this unit and in a previous

Federal Register notice.

1. Acute toxicity. In general, technical

pymetrozine has low acute toxicity,

being classified as Toxicity Category III

for acute dermal and primary eye

irritation studies and Toxicity Category

IV for acute oral, acute inhalation and

primary dermal studies. It is a slight

sensitizer.

2. Subchronic and chronic toxicity.

EPA’s September 29, 1999, Federal

Register notice (64 FR 52438–52450)

(FRL–6385–6) summarized the results of

the subchronic and chronic toxicity,

metabolism, and dermal penetration

studies in animals.

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 pymetrozine used for human risk

assessment was discussed in a previous

Federal Register notice of September

29, 1999 (64 FR 52438–52450) (FRL–

6385–6).

C. Exposure Assessment

1. Dietary exposure from food and

feed uses. Prior to this Rule, the Agency

had established tolerances for

pymetrozine in or on corm and tuberous

vegetables (Crop Subgroup 1-C) at 0.02

ppm, cucurbit vegetables (Crop Group 8)

at 0.05 ppm, and fruiting vegetables

(Crop Group 9) at 0.05 ppm (40 CFR

180.556). This Rule establishes new

tolerances for residues of pymetrozine

in or on a variety of raw agricultural

commodities: cotton seed, undelinted at

0.3 ppm; cotton gin byproducts at 2.0

ppm; fruiting vegetables at 0.2 ppm;

66788 Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Rules and Regulations

cucurbit vegetables at 0.1 ppm; leafy

vegetables (except Brassica) at 0.6 ppm;

head and stem Brassica vegetables at 0.5

ppm; leafy Brassica and turnip greens at

0.25 ppm; hops (dried) at 6.0 ppm; and

pecans at 0.02 ppm. Risk assessments

were conducted by EPA to assess

dietary exposures from pymetrozine 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. 100% of the crop

were treated, and the residue levels

were assumed to be at the tolerance

level.

Using these conservative

assumptions, the acute dietary (food

only) exposure to pymetrozine from all

existing and proposed uses (tuberous

and corm, fruiting, and cucurbit

vegetables; cotton seed (undelinted);

cotton gin byproducts; hops, dried; leafy

vegetables (except Brassica); head and

stem Brassica vegetables; leafy Brassica

greens; turnip greens; and pecans will

be below EPA’s level of concern (100%

of the acute Population-Adjusted Dose

(aPAD)) and will not occupy more than

5.9% of the aPAD for any population

subgroup, including those of infants and

children. For the maximum-exposed

subgroup, the 95th percentile of

exposure (Females 13–50 years old) is

predicted to be 5.9% of the aPAD. Due

to pymetrozine’s lower acute endpoint

for females 13–50 years old (0.033 mg/

kg) versus that of other population

subgroups (0.14 mg/kg for infants and

children), the percentage of the aPAD

occupied for females 13–50 years old

(5.9%) is higher than that estimated for

children 1–6 years old. For an exposure

analysis based on the assumptions that

100% of the crop is treated and residues

are at the tolerance level, EPA considers

exposure at the 95th percentile of

exposure to be a reasonable estimate of

high end of exposure. Even at the 99th

percentile of exposure, the acute risk is

well below EPA’s level of concern.

ii. Chronic exposure. In conducting

this chronic dietary risk assessment the

Dietary Exposure Evaluation Model

(DEEM) analysis evaluated the

individual food consumption as

reported by respondents in the USDA

1989–1992 nationwide Continuing

Surveys of Food Intake by Individuals

(CSFII) and accumulated exposure to

the chemical for each commodity. The

following assumptions were made for

the chronic exposure assessments. The

chronic analysis was a Tier 3 analysis.

See Table 1 below. It was necessary to

use both projected percent of crop

treated (%CT) estimates and anticipated

residues in the chronic analysis because

when %CT alone was used, one

population subgroup exceeded the

Agency’s level of concern.

The Tier 3 DEEM chronic analysis

indicates that exposure to pymetrozine

from tuberous and corm, fruiting, and

cucurbit vegetables; cotton seed

(undelinted); cotton gin byproducts;

hops, dried; leafy vegetables (except

Brassica); head and stem Brassica

vegetables; leafy Brassica greens; turnip

greens; and pecans will occupy less

than 3.4% of the cPAD for children ages

1–6 (the most highly exposed

population subgroup). Chronic dietary

risk to all other subgroups is less than

that of children ages 1–6.

TABLE 1.—RESULTS OF CHRONIC DIETARY EXPOSURE ANALYSIS

Subgroup cPAD (mg/

kg/day)

Exposure

(mg/kg/day) % cPAD

U.S. Population (total) 0.0038 0.000034 <1

All Infants (1 year old) 0.0013 0.000018 1.4

Children 1–6 years old 0.0013 0.000045 3.4

Children 7–12 years old 0.0013 0.000040 3.1

Females 13–50 0.0013 0.000029 2.2

Males 13–19 0.0038 0.000024 <1

Males 20+ years old 0.0038 0.000034 <1

Seniors 55+ 0.0038 0.000036 <1

iii. Cancer. The Agency’s level of

concern for cancer exposure is 1 x 10-6.

The lifetime risk of developing cancer

from pymetrozine exposure is

determined for the U.S. population

(total) only. The estimated exposure to

pymetrozine is 0.000034 mg/kg/day.

Applying the Q11* of 0.0119 (mg/kg/

day)-1 to the exposure value results in a

cancer risk estimate of 4.0 x 10-7.

Therefore, the lifetime risk to the U.S.

population of developing cancer from

dietary exposure to pymetrozine is

below EPA’s level of concern.

iv. Anticipated Residue and Percent

Crop Treated Information. 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 callin 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

Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Rules and Regulations 66789

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 registrant provided projected

percent crop treated data for

pymetrozine, and the Agency revised

them, as shown in the following Table

2.

TABLE 2.—PROJECTED PERCENT

CROP TREATED ESTIMATES

Crop %CT

Broccoli 25

Cabbage 12.2

Cantaloupes 25

Celery 25

Cotton 6

Cucumbers 10

Head Lettuce 25

Leaf Lettuce 25

Peppers 8

Potatoes 20

Pumpkins 10

Spinach 16.4

Squash (winter and summer) 8

Tomatoes 12

Watermelons 20

The Agency believes that the three

conditions listed above have been met.

With respect to Condition 1, for new

and existing uses, the Agency received

estimates from Syngenta based upon its

analysis of the marketing data that

compared all of the potential major

pesticides for cost, efficacy, and

demand. EPA received these figures and

performed its own independent

analysis. The Agency examined the

registrant’s data and assumptions for all

these factors. Based on the information

that the registrant has provided, together

with in-house data and information

from outside contacts if necessary, the

Agency agreed with the company’s

estimate of projected PCT for many

crops. For some crops, the Agency

revised the company’s estimates

upward.

For existing uses, 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. 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 values for the

percentage of the food treated, as shown

in Table 2 of this preamble, are

reasonable and are 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

pymetrozine may be applied in a

particular area.

2. Dietary exposure from drinking

water. The Agency lacks sufficient

monitoring exposure data to complete a

comprehensive dietary exposure

analysis and risk assessment for

pymetrozine 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

pymetrozine.

The Agency uses FIRST (FQPA Index

Reservoir Screening Tool) or PRZM/

EXAMS (Pesticide Root Zone/Exposure

Analysis Modeling System) program to

predict pesticide concentrations in

surface water; and SCI-GROW

(Screening Concentration In GROund

Water version 1.0) program to predict

pesticide concentrations in

groundwater.

The ’FIRST’ program is a tier I

screening model recently developed by

EPA. It is used as a coarse screen for

estimation of pesticide concentrations

based on index agricultural watersheddrinking water reservoir or index

reservoir (IR) scenario and percent

cropped area (CPA). The FIRST model

produces both a peak value (acute) and

an annual average (chronic) pesticide

concentration, or Estimated

Environmental Concentrations (EECs). If

the FIRST EECs are within 10% of a

DWLOC, EFED will move to the next

tier and perform a PRZM/EXAMS

assessment.

The PRZM/EXAMS is a tier II model

that provides an upper-bound estimate

of a pesticide’s concentration in a 1

hectare pond resulting from surface

water runoff from a 10 hectare field, and

is used to refine EECs generate by the

lower tier FIRST model. As with FIRST,

PRZM/EXAMS incorporates an index

reservoir environment and includes a

percent crop area factor as an

adjustment to account for the maximum

percent crop coverage within a

watershed or drainage basin. However,

this tier II model also uses NOAA

climatological (rainfall) data for a 36–

year period that allows for more realistic

runoff events. PRZM/EXAMS produces

maximum and annual concentrations

for each of the 36 years for which there

is rainfall data.

The Agency modeled six different

scenarios, using the maximum

application rate allowed for each crop:

cotton, cucurbits, tomatoes, cabbage,

pecans; and hops. The surface water

concentrations for these crops were

estimated using the Pesticide Root Zone

Model (PRZM version 3.12) (Carsel et

al., 1998) coupled with the Exposure

Analysis Modeling System ( EXAMS

version 2.97.5) (Burns, 1997) adjusted

with the appropriate (or default) percent

cropped area (PCA) factor. The PCA

factor reflects the maximum percentage

of a basin planted in the agricultural

crop being considered in the risk

66790 Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Rules and Regulations

assessment. EPA adapted a PCA factor

of 0.20 for cotton. However, PCA factors

are not available for cucurbits, tomatoes,

cabbage, pecans, or hops, and a default

value of 0.87 was used. This may result

in an overestimation of the surface

water concentrations for these crops

compared to the cotton crop. The pecan

scenario gives the highest estimated

surface water concentrations, mainly

due to a high level of rainfall in the

areas where pecans are grown

(sometimes as high as three times the

level of other crops considered in this

assessment) especially during the

summer season. The peak (acute) EEC is

5.23 ppb and the average annual

(chronic) EEC is 1.58 ppb.

PRZM is used to simulate pesticide

transport as a result of runoff and

erosion from an agricultural field.

EXAMS estimates environmental fate

and transport of pesticides in a

receiving water body. For human health

risk assessment, simulations were done

using the Index Reservoir scenario with

the consideration of a PCA factor.

Weather and agricultural practices are

simulated over 36 years so that the 10–

year exceedance probability at the site

can be estimated.

The SCI-GROW screening model was

also developed by EPA, and is a

regression model based upon actual

groundwater monitoring data collected

for the registration of a number of

pesticides. The current version of SCIGROW appears to provide a realistic

estimate of pesticide concentrations in

shallow, highly vulnerable ground water

sites (i.e., sites with sandy soils and

depth to ground water of 10 to 20 feet)

for use in both chronic and acute

ground water estimates.

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 pymetrozine

they are further discussed in the

aggregate risk sections below.

Based on the FIRST, SCI-GROW, and

PRZM/EXAMS models the EECs of

pymetrozine for acute exposures are

estimated to be 5.23 parts per billion

(ppb) for surface water and < 0.02 ppb

for ground water. The EECs for chronic

exposures are estimated to be 1.58 ppb

for surface water and < 0.02 ppb for

ground water. See Tables 3 and 4 below.

TABLE 3.—ACUTE DRINKING WATER LEVELS OF COMPARISON FOR AGGREGATED EXPOSURES

Scenario/Population Subgroup aPAD mg/

kg/day

Food Exposure,

mg/kg/day

Maximum

Water Exposure, mg/kg/day

SCI-GROW

(groundwater) ppb

PRZM/

EXAMS

(surface

water) ppb

DWLOC*

μg/L

U.S. Population 0.42 0.002119 0.41788 0.02 5.23 15,000

All Infants (<1 year old) 0.14 0.001404 0.13860 0.02 5.23 1,400

Children (1–6 yrs) 0.14 0.003517 0.13648 0.02 5.23 1,400

Children 7–12 years old 0.14 0.002615 0.13739 0.02 5.23 1,400

Females 13–50 0.033 0.001939 0.031061 0.02 5.23 930

Males 13–19 0.42 0.001722 0.41828 0.02 5.23 15,000

Males 20+ years old 0.42 0.001807 0.41819 0.02 5.23 15,000

Seniors 55+ 0.42 0.002035 0.41797 0.02 5.23 15,000

* DWLOC = Maximum Water Exposure (mg/kg/day) 1000 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). The acute EEC is 5.23 μg/L.

TABLE 4. CHRONIC DRINKING WATER LEVELS OF COMPARISON FOR AGGREGATED EXPOSURES

Scenario/Population Subgroup cPAD mg/

kg/day

Food Exposure,

mg/kg/day

Maximum

Water Exposure, mg/kg/day

SCI-GROW

(groundwater) ppb

PRZM/

EXAMS

(surface

water) ppb

DWLOC*

μg/L

U.S. Population 0.0038 0.000034 0.003766 0.02 1.58 130

All Infants (<1 year old) 0.0013 0.000018 0.001282 0.02 1.58 13

Children (1–6 years old) 0.0013 0.000045 0.001255 0.02 1.58 13

Children 7–12 years 0.0013 0.000040 0.001260 0.02 1.58 13

Females 13–50 0.0013 0.000029 0.001271 0.02 1.58 38

Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Rules and Regulations 66791

TABLE 4. CHRONIC DRINKING WATER LEVELS OF COMPARISON FOR AGGREGATED EXPOSURES—Continued

Scenario/Population Subgroup cPAD mg/

kg/day

Food Exposure,

mg/kg/day

Maximum

Water Exposure, mg/kg/day

SCI-GROW

(groundwater) ppb

PRZM/

EXAMS

(surface

water) ppb

DWLOC*

μg/L

Males 13–19 0.0038 0.000024 0.003776 0.02 1.58 130

Males 20+ years old 0.0038 0.000034 0.003766 0.02 1.58 130

Seniors 55+ 0.0038 0.000036 0.003764 0.02 1.58 130

* DWLOC = 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). The chronic and cancer EEC is 1.58 μg/L.

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). Since the

current proposed uses do not result in

additional residential exposure, the

Agency’s earlier evaluation of approved

residential uses, found in the Federal

Register of August 9, 2000 (65 FR

48626–48634), will not be repeated

here.

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.’’

Based on the information available to

EPA, there are no other pesticides that

have a common mechanism of toxicity

with pymetrozine. Unlike other

pesticides for which EPA has followed

a cumulative risk approach based on a

common mechanism of toxicity,

pymetrozine 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 pymetrozine 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. 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. Conclusion. There is a complete

toxicity database for pymetrozine and

exposure data are complete or are

estimated based on data that reasonably

accounts for potential exposures. EPA

determined that the 10X safety factor to

protect infants and children could be

reduced to 3. The FQPA factor is

reduced after assessing the potential for

additional sensitivity of infants and

children to residues of pymetrozine in

the following studies: developmental

toxicity studies in rabbit and rat and

two-generation reproduction study in

the rat. There was no evidence of

increased susceptibility in these studies.

The FQPA safety factor was not reduced

to one due to the need for a

developmental neurotoxicity study.

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

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. The Tier 1 exposure

estimates provided by the acute dietary

analysis are based on the assumption

that tolerance-level residues are present

in/on all commodities on which

pymetrozine will be used and that 100%

of these commodities are treated. The

exposure estimates are therefore

conservative ones. As shown in Table 3

of this preamble the acute EECs for

pymetrozine are below EPA’s level of

concern. That is, they are below the

DWLOC values calculated for the

various population subgroups. Thus,

residues of pymetrozine in food and

66792 Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Rules and Regulations

drinking water do not exceed the EPA’s

level of concern (100% of the aPAD) for

acute aggregate exposure for any of the

population subgroups. Based on its

assumptions and underlying data, this

risk assessment is considered confident,

very conservative, and highly protective

of human health.

2. Chronic risk. The Tier 3 exposure

estimates provided by the chronic

dietary analysis are based on anticipated

residues and projected percent crop

treated data. Anticipated residues

(average field trial values) were

calculated for the crops. The resulting

exposure estimates are therefore refined

ones. The chronic EECs for pymetrozine

are below the Agency’s level of concern.

That is, as shown in Table 4 of this

preamble, they are below the DWLOC

values calculated for the various

population subgroups. Thus, residues of

pymetrozine in food and drinking water

do not exceed the Agency’s level of

concern (100% of the cPAD) for chronic

aggregate exposure for any of the

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). In

aggregating short-term risk, the Agency

considered background average dietary

exposure and short-term, non-dietary

oral exposure. Non-dietary oral

exposure may occur with toddlers as

hand-to-mouth transfer of residues from

ornamental plants or incidental

ingestion of treated ornamental plants

and/or surrounding soil. The highest

estimated exposure via these routes is

0.0046 mg/kg/day which results from

hand-to-mouth transfer of residues.

Combining this exposure with the

chronic dietary exposure estimate of

0.000045 mg/kg/day results in an

aggregate exposure of 0.0046 mg/kg/day.

In the absence of a short-term oral

endpoint, EPA has used the acute

dietary endpoint for infants and

children (125 mg/kg/day) to estimate

aggregate short-term risk. Note that this

endpoint is based on a LOAEL and

therefore has a 300–fold uncertainty

factor associated with it. Combining the

exposure estimate with the toxicological

endpoint gives an MOE of 27,000. For

this scenario, the Agency would be

concerned with an MOE of less than

900; thus, this exposure is below EPA’s

level of concern. Aggregated short-term

exposure results in a DWLOC of 1,400

ppb. This value is in excess of the peak

EEC of 5.23 ppb for pymetrozine.

Therefore, the short-term aggregate risk

is below the Agency’s level of concern.

4. Intermediate-term risk.

Intermediate-term aggregate exposure

takes into account residential exposure

plus chronic exposure to food and water

(considered to be a background

exposure level). There are no

intermediate-term residential exposure

scenarios for pymetrozine based on the

current uses. Therefore, aggregate

intermediate-term risks do not exceed

the Agency’s level of concern.

5. Aggregate cancer risk for U.S.

population. As with the chronic dietary

exposure analysis, the cancer risk

assessment is also based on a Tier 3

estimate of dietary exposure. The cancer

aggregate risk consists of chronic dietary

exposure as well as non-occupational

exposure resulting from pruning and

planting treated ornamental plants. The

sum of the food and residential

exposure is 0.000034 (food) + 0.0000012

(residential) = 3.5 x 10-5 mg/kg/day.

Assuming a cancer risk limit of 1 x 10-6,

the cancer dose of concern is 8.4 x 10-5

mg/kg/day (0.000001/Q1* = 0.000001/

0.0119). As 3.5 x 10-5 mg/kg/day is less

than 8.4 x 10-5 mg/kg/day, the aggregate

food and residential exposure is below

the level of concern. With respect to

drinking water, the cancer DWLOC is

calculated to be 1.7 ppb. The highest

EEC for any of the crops in these

petitions is 1.6 ppb (pecans). As a result,

the aggregate cancer risk resulting from

use of pymetrozine is below the

Agency’s level of concern.

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 pymetrozine

residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

The Agency’s Analytical Chemistry

Laboratory has validated an

enforcement methodology for

pymetrozine (Syngenta Analytical

Method AG–643A). It will be available

to enforce the tolerance expression. The

method may be requested from: Francis

D. Griffith, Jr., Analytical Chemistry

Branch, BEAD (7503C), 702 mapes Rd.,

Ft. George Meade, MD 20755–5350;

telephone number: (410) 305–2905; email address: griffin.francis@epa.gov.

B. International Residue Limits

There are no established European

(CODEX), Canadian, or Mexican

Maximum Residue Limits (MRL’s) for

pymetrozine. There are provisional

MRLs in Germany for hops, dried (10

ppm) and potatoes (0.02 ppm). The

European Union is currently evaluating

a proposed tolerance of 5 ppm on hops,

dried. There are proposed tolerances in

Canada for tuberous and corm

vegetables at 0.02 ppm, fruiting

vegetables at 0.2 ppm, head and stem

Brassica vegetables at 2.0 ppm, leafy

Brassica vegetables at 5.0 ppm, leafy

vegetables at 6.0 ppm, pecans at 0.02

ppm, hops (dried) at 5.0 ppm, citrus at

0.2 ppm, and cucurbits at 0.1 ppm. At

this time, international harmonization

of residue levels is not an issue.

C. Conditions

The Agency imposed the following

conditions on pymetrozine at the time

of the original Notices of Registration in

the fall of 1999:

1. Storage stability (due December

2000).

2. Corrosion characteristics (due

December 2000).

3. Acute estuarine/marine toxicity in

shrimp (due October 2000)

4. Photodegradation on soil, 161–3,

(due October 2000).

5. Developmental neurotoxicity

Study, 870–6300 or 83–6, (due October

2001).

6. Avian reproduction (mallard), 71–

4(b), (due October 2001).

7. Drinking water monitoring

(originally due October 2002 but the

requirement was no longer applicable

after Cancer Q* was changed).

V. Conclusion

Therefore, the tolerances are

established for residues of pymetrozine

in or on cotton seed, undelinted at 0.3

ppm; cotton gin byproducts at 2.0 ppm;

fruiting vegetables at 0.2 ppm; cucurbit

vegetables at 0.1 ppm; leafy vegetables

(except Brassica) at 0.6 ppm; head and

stem Brassica vegetables at 0.5 ppm;

leafy Brassica and turnip greens at 0.25

ppm, hops (dried) at 6.0 ppm; and

pecans at 0.02 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

Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Rules and Regulations 66793

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–301180 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 25, 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

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–301180, 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

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

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

66794 Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Rules and Regulations

have federalism implications.’’ ‘‘Policies

that have federalism implications’’ is

defined in the Executive Order to

include regulations that have

‘‘substantial direct effects on the States,

on the relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government.’’ This final rule

directly regulates growers, food

processors, food handlers and food

retailers, not States. This action does not

alter the relationships or distribution of

power and responsibilities established

by Congress in the preemption

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

For these same reasons, the Agency has

determined that this rule does not have

any tribal implications as described in

Executive Order 13175, entitled

Consultation and Coordination with

Indian Tribal Governments (65 FR

67249, November 6, 2000). Executive

Order 13175, requires EPA to develop

an accountable process to ensure

meaningful and timely input by tribal

officials in the development of

regulatory policies that have tribal

implications. Policies that have tribal

implications is defined in the Executive

Order to include regulations that have

substantial direct effects on one or more

Indian tribes, on the relationship

between the Federal government and

the Indian tribes, or on the distribution

of power and responsibilities between

the Federal government and Indian

tribes. This rule will not have

substantial direct effects on tribal

governments, on the relationship

between the Federal government and

Indian tribes, or on the distribution of

power and responsibilities between the

Federal government and Indian tribes,

as specified in Executive Order 13175.

Thus, Executive Order 13175 does not

apply to this rule.

VIII. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

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

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit a

report containing this rule and other

required information to the U.S. Senate,

the U.S. House of Representatives, and

the Comptroller General of the United

States prior to publication of this final

rule in the Federal Register. This final

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

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

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: December 17, 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 180.556 is amended by

revising paragraph (a) to read as follows:

§ 180.556 Pymetrozine; tolerances for

residues.

(a) General. Tolerances are

established for residues of the

insecticide pymetrozine 1,2,4-triazin3(2H)-one,4,5-dihydro-6-methyl-4-[(3-

pyridinylmethylene) amino] in or on the

following raw agricultural commodities.

The tolerance level for each commodity

is expressed in terms of the parent

insecticide only, which serves as an

indicator of the use of pymetrozine on

these raw agricultural commodities.

Commodity Parts per

million

Brassica, head and stem, subgroup (Crop Subgroup 5-A) .. 0.5

Brassica, leafy greens, subgroup (Crop Subgroup 5-B) .. 0.25

Cotton gin byproducts .............. 2.0

Cotton, undelinted seed ........... 0.3

Hops, dried cones .................... 6.0

Pecans ...................................... 0.02

Turnip, greens .......................... 0.25

Vegetable, fruiting, group (Crop

Group 8) ................................ 0.2

Vegetable, cucurbit, group

(Crop Group 9) ...................... 0.1

Vegetable, leafy, execpt brassica, group (Crop Group 4) ... 0.6

Vegetable, tuberous and corm,

subgroup (Crop Subgroup 1-

C) .......................................... 0.02

* * * * *

[FR Doc. 01–31801 Filed 12–26–01; 8:45 am]

BILLING CODE 6560–50–S

GENERAL SERVICES

ADMINISTRATION

41 CFR Chapter 301

[FTR Amendment 99]

RIN 3090–AH51

Federal Travel Regulation; Maximum

Per Diem Rates

AGENCY: Office of Governmentwide

Policy, GSA.

ACTION: Final rule.

SUMMARY: This final rule amends the

Federal Travel Regulation (FTR),

Amendment 97, published in the

Federal Register of Friday, August 31,

2001. This final rule updates the table

of prescribed maximum per diem rates

for the continental United States

(CONUS) by revising previous entries

and adding new entries.

EFFECTIVE DATE: October 1, 2001.

FOR FURTHER INFORMATION CONTACT:

Joddy P. Garner, Office of

Governmentwide Policy (MTT),

Washington, DC 20405, telephone 202-

501–4857.

SUPPLEMENTARY INFORMATION:

A. Background

The General Services Administration

(GSA), after an analysis of additional

data, is revising previous entries and

adding new entries that were

inadvertently omitted from FTR

Amendment 97 published as Part II in

the Federal Register of Friday, August

31, 2001 (66 FR 46070). This final rule

revises the key city for Pontiac/Troy,

Michigan, and the county and/or other

defined locations for Denver, Colorado;

Anoka County, Minnesota; Harrisburg

and Hershey, Pennsylvania; and Sturgis,

South Dakota. This final rule further

adds new per diem city/county

localities and rates for Dinwiddie

County, Hopewell, Petersburg, and

Prince George County, Virginia. In

addition, this final rule revises footnote

four (4) of the per diem rate table.

B. Executive Order 12866

GSA has determined that this final

rule is not a significant regulatory action

for the purposes of Executive Order

12866 of September 30, 1993.

C. Regulatory Flexibility Act

This final rule is not required to be

published in the Federal Register for

notice and comment; therefore, the

Regulatory Flexibility Act, 5 U.S.C. 601

et seq., does not apply.

D. Paperwork Reduction Act

The Paperwork Reduction Act does

not apply because this final rule does