57966 Federal Register / Vol. 65, No. 188 / Wednesday, September 27, 2000 / Rules and Regulations

Commodity Parts per

million

Durian ....................................... 0.2

Egg ........................................... 0.05

Epazote ..................................... 1.3

Feijoa ........................................ 0.2

Fig ............................................. 0.2

Fish ........................................... 0.25

Flax, meal ................................. 8.0

Flax, seed ................................. 4.0

Fruit, citrus, group .................... 0.5

Fruit, pome, group .................... 0.2

Fruit, stone, group .................... 0.2

Galangal root ............................ 0.2

Ginger, white, flower ................. 0.2

Goat, kidney ............................. 4.0

Goat, liver ................................. 0.5

Gourd, buffalo, seed ................. 0.1

Governor’s plum ....................... 0.2

Gow kee, leaves ....................... 0.2

Grain, cereal, group (except

barley, field corn, grain sorghum, oats and wheat) ......... 0.1

Grain, cereal, stover and straw,

group ..................................... 100

Grape ........................................ 0.2

Grass, forage, fodder and hay,

group ..................................... 200

Guava ....................................... 0.2

Herbs subgroup ........................ 0.2

Hog, kidney ............................... 4.0

Hog, liver .................................. 0.5

Hop, dried cones ...................... 7.0

Horse, kidney ............................ 4.0

Horse, liver ............................... 0.5

Ilama ......................................... 0.2

Imbe .......................................... 0.2

Imbu .......................................... 0.2

Jaboticaba ................................ 0.2

Jackfruit .................................... 0.2

Jojoba, seed ............................. 0.1

Juneberry .................................. 0.2

Kava, roots ............................... 0.2

Kenaf, forage ............................ 200

Kiwifruit ..................................... 0.2

Lesquerella, seed ..................... 0.1

Leucaena, forage ...................... 200

Lingonberry ............................... 0.2

Longan ...................................... 0.2

Lychee ...................................... 0.2

Mamey apple ............................ 0.2

Mamey sapote .......................... 0.2

Mango ....................................... 0.2

Mangosteen .............................. 0.2

Marmaladebox .......................... 0.2

Meadowfoam, seed .................. 0.1

Mioga, flower ............................ 0.2

Mustard, seed ........................... 0.1

Nut, pine ................................... 1.0

Nut, tree, group ........................ 1.0

Oat, grain .................................. 20

Okra .......................................... 0.5

Olive .......................................... 0.2

Oregano, Mexican, leaves ........ 2.0

Palm heart ................................ 0.2

Palm heart, leaves .................... 0.2

Palm, oil .................................... 0.1

Papaya ...................................... 0.2

Papaya, mountain ..................... 0.2

Passionfruit ............................... 0.2

Pawpaw .................................... 0.2

Peanut ...................................... 0.1

Peanut, forage .......................... 0.5

Peanut, hay .............................. 0.5

Pepper leaf, fresh leaves ......... 0.2

Commodity Parts per

million

Peppermint, tops ...................... 200

Perilla, tops ............................... 1.8

Persimmon ................................ 0.2

Pineapple .................................. 0.1

Pistachio ................................... 1.0

Pomegranate ............................ 0.2

Poultry, meat ............................ 0.1

Poultry, meat byproduct ........... 1.0

Pulasan ..................................... 0.2

Quinoa, grain ............................ 5.0

Rambutan ................................. 0.2

Rapeseed, meal ....................... 15

Rapeseed, seed ....................... 10

Rose apple ............................... 0.2

Safflower, seed ......................... 0.1

Salal .......................................... 0.2

Sapodilla ................................... 0.2

Sapote, black ............................ 0.2

Sapote, white ............................ 0.2

Sesame, seed ........................... 0.1

Sheep, kidney ........................... 4.0

Sheep, liver ............................... 0.5

Shellfish .................................... 3.0

Sorghum, grain, grain ............... 15

Soursop .................................... 0.2

Soybean, seed .......................... 20

Soybean, aspirated grain fractions ....................................... 50

Soybean, forage ....................... 100

Soybean, hay ............................ 200

Soybean, hulls .......................... 100

Spanish lime ............................. 0.2

Spearmint, tops ........................ 200

Spices subgroup ....................... 7.0

Star apple ................................. 0.2

Starfruit ..................................... 0.2

Stevia, dried leaves .................. 1.0

Strawberry ................................ 0.2

Sugar apple .............................. 0.2

Sugarcane ................................ 2.0

Sugarcane, molasses ............... 30

Sunflower, seed ........................ 0.1

Surinam cherry ......................... 0.2

Tamarind ................................... 0.2

Tea, dried ................................. 1.0

Tea, instant ............................... 7.0

Teff, grain ................................. 5.0

Ti, leaves .................................. 0.2

Ti, roots ..................................... 0.2

Ugli fruit .................................... 0.5

Vegetable, Brassica leafy,

group ..................................... 0.2

Vegetable, bulb, group ............. 0.2

Vegetable, cucurbit, group ....... 0.5

Vegetable, foliage of legume,

group (except soybean forage and hay) ......................... 0.2

Vegetable, fruiting, group ......... 0.1

Vegetable, leafy, group ............ 0.2

Vegetable, leaves of root and

tuber, group(except sugar

beet tops) .............................. 0.2

Vegetable, legume, group (except soybean) ....................... 5.0

Vegetable, root and tuber,

group (except sugar beet) .... 0.2

Wasabi, roots ............................ 0.2

Water spinach, tops .................. 0.2

Watercress, upland ................... 0.2

Wax jambu ................................ 0.2

Wheat, grain ............................. 5.0

Wheat, milling fractions (except

flour) ...................................... 20

Commodity Parts per

million

Yacon, tuber ............................. 0.2

* * * * *

(d) Indirect or inadvertent residues.

[Reserved]

FR Doc. 00–24318 Filed 9–26–00; 8:45 am

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301048; FRL–6744–1]

RIN 2070–AB78

Ethametsulfuron-methyl; Pesticide

Tolerances for Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for residues of

ethametsulfuron-methyl in or on canola.

This action is in response to EPA’s

granting of emergency exemption under

section 18 of the Federal Insecticide,

Fungicide, and Rodenticide Act

authorizing use of the pesticide on

canola. This regulation establishes a

maximum permissible level for residues

of ethametsulfuron-methyl in this food

commodity. The tolerance will expire

and is revoked on December 31, 2001.

DATES: This regulation is effective

September 27, 2000. Objections and

requests for hearings, identified by

docket control number OPP–301048,

must be received by EPA on or before

November 27, 2000.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, in person, or by courier. Please

follow the detailed instructions for each

method as provided in Unit VII. of the

SUPPLEMENTARY INFORMATION section of

the document. To ensure proper receipt

by EPA, your objections and hearing

requests must identify docket control

number OPP–301048 in the subject line

on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Dan Rosenblatt, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 308–9375; and e-mail

address: rosenblatt.dan@epa.gov.

SUPPLEMENTARY INFORMATION:

Federal Register / Vol. 65, No. 188 / Wednesday, September 27, 2000 / Rules and Regulations 57967

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by

this action if you are an agricultural

producer, food manufacturer, or

pesticide manufacturer. Potentially

affected categories and entities may

include, but are not limited to:

Categories NAICS

Examples of Potentially Affected Entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional

Information, Including Copies of This

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations,’’ ‘‘Regulations

and Proposed Rules,’’ and then look up

the entry for this document under the

‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–301048. 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, 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

EPA, on its own initiative, in

accordance with sections 408 (l)(6) of

the Federal Food, Drug, and Cosmetic

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

establishing a tolerance for residues of

the herbicide ethametsulfuron-methyl,

in or on canola at 0.02 part per million

(ppm). This tolerance will expire and is

revoked on December 31, 2001. EPA

will publish a document in the Federal

Register to remove the revoked

tolerance from the Code of Federal

Regulations.

Section 408(l)(6) of the FFDCA

requires EPA to establish a time-limited

tolerance or exemption from the

requirement for a tolerance for pesticide

chemical residues in food that will

result from the use of a pesticide under

an emergency exemption granted by

EPA under section 18 of FIFRA. Such

tolerances can be established without

providing notice or period for public

comment. EPA does not intend for its

actions on section 18 related tolerances

to set binding precedents for the

application of section 408 and the new

safety standard to other tolerances and

exemptions.

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. . . .’’

Section 18 of the Federal Insecticide,

Fungicide, and Rodenticide Act (FIFRA)

authorizes EPA to exempt any Federal

or State agency from any provision of

FIFRA, if EPA determines that

‘‘emergency conditions exist which

require such exemption.’’ This

provision was not amended by the Food

Quality Protection Act (FQPA). EPA has

established regulations governing such

emergency exemptions in 40 CFR part

166.

III. Emergency Exemption for

Ethametsulfuron-methyl on Canola and

FFDCA Tolerances

EPA has authorized under FIFRA

section 18 the use of ethametsulfuronmethyl on canola for control of

smartweeds in North Dakota and

Minnesota. Products containing

endothall had been available for use

against smartweeds in the past.

However, this use of endothall is no

longer being supported. Therefore, after

considering the situation this year, EPA

determined that emergency conditions

existed for the growers and permitted

the use.

As part of its assessment of this

emergency exemption, EPA assessed the

potential risks presented by residues of

ethametsulfuron-methyl in or on canola.

In doing so, EPA considered the safety

standard in FFDCA section 408(b)(2),

and EPA decided that the necessary

tolerance under FFDCA section 408(l)(6)

would be consistent with the safety

standard and with FIFRA section 18.

Consistent with the need to move

quickly on the emergency exemption in

order to address an urgent non-routine

situation and to ensure that the resulting

food is safe and lawful, EPA is issuing

this tolerance without notice and

opportunity for public comment as

provided in section 408(l)(6). Although

this tolerance will expire and is revoked

on December 31, 2001, under FFDCA

section 408(l)(5), residues of the

pesticide not in excess of the amounts

specified in the tolerance remaining in

or on canola after that date will not be

unlawful, provided the pesticide is

applied in a manner that was lawful

under FIFRA, and the residues do not

exceed a level that was authorized by

this tolerance at the time of that

application. EPA will take action to

revoke this tolerance earlier if any

experience with, scientific data on, or

other relevant information on this

pesticide indicate that the residues are

not safe.

Because this tolerance is being

approved under emergency conditions,

EPA has not made any decisions about

whether ethametsulfuron-methyl meets

EPA’s registration requirements for use

57968 Federal Register / Vol. 65, No. 188 / Wednesday, September 27, 2000 / Rules and Regulations

on canola or whether a permanent

tolerance for this use would be

appropriate. Under these circumstances,

EPA does not believe that this tolerance

serves as a basis for registration of

ethametsulfuron-methyl by a State for

special local needs under FIFRA section

24(c). Nor does this tolerance serve as

the basis for any State other than North

Dakota and Minnesota to use this

pesticide on this crop under section 18

of FIFRA without following all

provisions of EPA’s regulations

implementing section 18 as identified in

40 CFR part 166. For additional

information regarding the emergency

exemption for ethametsulfuron-methyl,

contact the Agency’s Registration

Division at the address provided under

FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and

Determination of Safety

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).

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 ethametsulfuron-methyl and

to make a determination on aggregate

exposure, consistent with section

408(b)(2), for a time-limited tolerance

for ethametsulfuron-methyl in or on

canola at 0.02 ppm. EPA’s assessment of

the dietary exposures and risks

associated with establishing the

tolerance follows.

A. Toxicological Endpoints

The dose at which no observed

adverse effect level (NOAEL) are

observed from the toxicology study

identified as appropriate for use in risk

assessment is used to estimate the

toxicological endpoint. However, the

lowest observed adverse effect level

(LOAEL) at which adverse effects of

concern are identified 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

intraspecies 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 level of concern (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 ethametsulfuron-methyl used for

human risk assessment is shown in the

following Table 1.

TABLE 1. — SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR ETHAMETSULFURON-METHYL FOR USE IN HUMAN

RISK ASSESSMENT

Exposure scenario Dose used in risk assessment, UF

FQPA SF* and level of concern for risk assessment Study and toxicological effects

Acute dietary NOAEL = none acute RfD =

n/a

FQPA SF = 1x aPAD = n/a A dose and endpoint were not selected since

toxicological effects attributable to a single

dose (exposure) were not available from the

oral toxicological studies, including developmental toxicity studies in rats and rabbits.

Chronic dietary NOAEL = 449 mg/kg/day

UF = 100 chronic RfD =

4.5 mg/kg/day

FQPA SF = 1 x cPAD = 4.5

(chronic NOAEL)/ 1 x

(FQPA SF) = 4.5 mg/kg/

day

Parental/systemic NOAEL = 449 mg/kg/day

based on reduced body weight and body

weight gain in P and F1a males and females

at the LOAEL of 1,817 mg/kg/day in a 2–generation reproduction study.

Short-term, Intermediate-term,

and Long-term dermal

Dermal (or oral) study

NOAEL = n/a

LOC for MOE = n/a A dose and endpoint were not identified since

the dermal toxicity study in rats was waived

based on lack of systemic toxicity in oral toxicity studies.

Inhalation (any time period) Inhalation (or oral) study

NOAEL = n/a

LOC for MOE = n/a No inhalation endpoints were selected.

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

Federal Register / Vol. 65, No. 188 / Wednesday, September 27, 2000 / Rules and Regulations 57969

B. Exposure Assessment

1. Dietary exposure from food and

feed uses. This is the first food use

tolerance that will be established for

this herbicide. In support of this action,

risk assessments were conducted by

EPA to assess dietary exposures from

ethametsulfuron-methyl 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. For this action,

no acute dietary risk assessment was

conducted. The rationale for this is that

a dose and endpoint were not selected

since toxicological effects attributable to

a single dose (exposure) were not

available from the oral toxicology

studies, including developmental

toxicity studies in rats and rabbits.

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: A

conservative Tier I analysis using

tolerance level residues was performed.

Besides the use connected with this

action, there are no other food use or

residential registrations for

ethametsulfuron-methyl. Percent croptreated refinements and anticipated

residues were not used.

iii. Cancer. EPA did not conduct a

quantitative cancer risk assessment for

this action. The basis for this decision

is that no evidence of chronic toxicity

or carcinogenicity was seen in mice and

rats; although, the dose levels tested in

these studies were determined to be

inadequate. The cancer potential for

other sulfonylurea herbicides is also

germane to this decision. Other

sulfonylurea herbicides do not show

evidence of carcinogenicity or

mutagenicity.

2. Dietary exposure from drinking

water. The Agency lacks sufficient

monitoring exposure data to complete a

comprehensive dietary exposure

analysis and risk assessment for

ethametsulfuron-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

ethametsulfuron-methyl.

The Agency uses the Generic

Estimated Environmental Concentration

(GENEEC) or the Pesticide Root Zone/

Exposure Analysis Modeling System

(PRZM/EXAMS) to estimate pesticide

concentrations in surface water and

Screening Concentration in Ground

Water (SCI-GROW), which predicts

pesticide concentrations in ground

water. In general, EPA will use GENEEC

(a tier 1 model) before using PRZM/

EXAMS (a tier 2 model) for a screeninglevel assessment for surface water. The

GENEEC model is a subset of the PRZM/

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

GENEEC incorporates a farm pond

scenario, while PRZM/EXAMS

incorporate an index reservoir

environment in place of the previous

pond scenario. The PRZM/EXAMS

model includes a percent crop area

factor as an adjustment to account for

the maximum percent crop coverage

within a watershed or drainage basin.

None of these models include

consideration of the impact processing

(mixing, dilution, or treatment) of raw

water for distribution as drinking water

would likely have on the removal of

pesticides from the source water. The

primary use of these models by the

Agency at this stage is to provide a

coarse screen for sorting out pesticides

for which it is highly unlikely that

drinking water concentrations would

ever exceed human health levels of

concern.

Since the models used are considered

to be screening tools in the risk

assessment process, the Agency does

not use estimated environmental

concentrations (EECs) from these

models to quantify drinking water

exposure and risk as a %RfD or %PAD.

Instead drinking water levels of

comparison (DWLOCs) are calculated

and used as a point of comparison

against the model estimates of a

pesticide’s concentration in water.

DWLOCs are theoretical upper limits on

a pesticide’s concentration in drinking

water in light of total aggregate exposure

to a pesticide in food, and from

residential uses. Since DWLOCs address

total aggregate exposure to

ethametsulfuron-methyl they are further

discussed in the aggregate risk sections

below.

Based on the PRZM/EXAMS and SCIGROW models the estimated EECs of

ethametsulfuron-methyl in surface

water and ground water, respectively,

for chronic exposures are estimated to

be 0.3 parts per billion (ppb) for surface

water and 0.1 ppb for ground water.

3. From non-dietary exposure. The

term ‘‘residential exposure’’ is used in

this document to refer to nonoccupational, non-dietary exposure

(e.g., for lawn and garden pest control,

indoor pest control, termiticides, and

flea and tick control on pets).

Ethametsulfuron-methyl is not

registered for use on any sites that

would result in residential exposure.

4. Cumulative exposure to substances

with a common mechanism of toxicity.

Section 408(b)(2)(D)(v) requires that,

when considering whether to establish,

modify, or revoke a tolerance, the

Agency consider ‘‘available

information’’ concerning the cumulative

effects of a particular pesticide’s

residues and ‘‘other substances that

have a common mechanism of toxicity.’’

EPA does not have, at this time,

available data to determine whether

ethametsulfuron-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, ethametsulfuronmethyl 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 ethametsulfuron-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

Bifenthrin Pesticide Tolerances (62 FR

62961, November 26, 1997).

C. Safety Factor for Infants and Children

1. Safety factor for infants and

children—i. In general. FFDCA section

408 provides that EPA shall apply an

additional tenfold margin of safety for

infants and children in the case of

threshold effects to account for prenatal

and postnatal toxicity and the

completeness of the data base on

toxicity and exposure unless EPA

determines that a different margin of

safety will be safe for infants and

children. Margins of safety are

incorporated into EPA risk assessments

either directly through use of a margin

of exposure (MOE) analysis or through

using uncertainty (safety) factors in

calculating a dose level that poses no

appreciable risk to humans.

ii. Developmental toxicity studies.

EPA has determined that there is

adequate information about prenatal

developmental toxicity to conclude that

ethametsulfuron-methyl does not pose a

57970 Federal Register / Vol. 65, No. 188 / Wednesday, September 27, 2000 / Rules and Regulations

risk of increased sensitivity due to in

utero exposure.

iii. Reproductive toxicity study. There

are adequate data for EPA to conclude

that there is no indication of increased

susceptibility of reproductive toxicity.

iv. Prenatal and postnatal sensitivity.

EPA considers the toxicology data base

to be complete and has concluded that

there is no indication of prenatal and

postnatal sensitivity in rats and rabbits.

v. Conclusion. There is a complete

toxicity data base for ethametsulfuronmethyl and exposure data are complete

or are estimated based on data that

reasonably accounts for potential

exposures. Given that EPA considers

that the toxicology data base for

ethametsulfuron-methyl is complete.

There is no indication of increased

susceptibility of rat or rabbit fetuses to

in utero and or postnatal exposure in the

developmental and reproductive

toxicity data. Unrefined dietary

exposure estimates are protective since

they will exaggerate dietary exposure

estimates; and there are currently no

registered residential uses for

ethametsulfuron-methyl, and therefore,

non-dietary exposure to infants and

children is not expected. These factors

led EPA to conclude that the special

10X safety factor for infants and

children should be removed to 1X.

D. 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 + chronic non-dietary, nonoccupational 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 US EPA Office of Water

are used to calculate DWLOCs: 2 liters

(L)/70 kilograms (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 ethametsulfuron-methyl 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 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

ethametsulfuron- methyl on drinking

water as a part of the aggregate risk

assessment process.

1. Acute risk. An aggregate acute risk

assessment was not conducted since a

dose and endpoint were not selected

because toxicological effects attributable

to a single dose (exposure) were not

available from the oral toxicology

studies, including developmental

toxicity studies in rats and rabbits.

2. Chronic risk. Using the exposure

assumptions described in this unit for

chronic exposure, EPA has concluded

that exposure to ethametsulfuronmethyl from food will utilize 0.0% of

the cPAD for the U.S. population and all

other sub populations. There are no

residential uses for ethametsulfuronmethyl that result in chronic residential

exposure to ethametsulfuron-methyl. In

addition, despite the potential for

chronic dietary exposure to

ethametsulfuron-methyl in drinking

water, after calculating the DWLOCs

and comparing them to conservative

model estimated environmental

concentrations of ethametsulfuronmethyl in surface and ground water,

EPA does not expect the aggregate

exposure to exceed 100% of the cPAD,

as shown in the following Table 2.

TABLE 2.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO ETHAMETSULFURON-METHYL

Population Subgroup cPAD mg/kg/day %cPAD

(Food)

Surface

Water EEC

(ppb)

Ground

Water EEC

(ppb)

Chronic DWLOC

(microgram s/L)

U.S. Population 4.5 mg/kg/day 0.0 0.32 ppb 0.11 ppb 160,000

Females 13+ 4.5 mg/kg/day 0.0 0.32 ppb 0.11 ppb 140,000

Infant and Children 4.5 mg/kg/day 0.0 0.32 ppb 0.11 ppb 45,000

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).

Ethametsulfuron-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

were previously addressed.

4. Intermediate-term risk.

Intermediate-term aggregate exposure

takes into account non-dietary, nonoccupational exposure plus chronic

exposure to food and water (considered

to be a background exposure level).

Ethametsulfuron-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

were previously addressed.

5. Aggregate cancer risk for U.S.

population. No evidence of chronic

toxicity or carcinogenicity was seen in

mice and rats; however, the dose levels

tested in these studies were determined

to be inadequate. However, it is noted

that other sulfonylurea herbicides do

not show evidence of carcinogenicity or

mutagenicity. Therefore a quantitative

risk assessment is not warranted.

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

Federal Register / Vol. 65, No. 188 / Wednesday, September 27, 2000 / Rules and Regulations 57971

from aggregate exposure to

ethametsulfuron-methyl residues.

V. Other Considerations

A. Analytical Enforcement Methodology

The manufacturer of ethametsulfuronmethyl has submitted a proposed

enforcement method to EPA (MRID #

42022113).

B. International Residue Limits

No Codex, Canadian, or Mexican

maximum residue level’s have been

established for ethametsulfuron-methyl.

VI. Conclusion

Therefore, the tolerance is established

for ethametsulfuron-methyl, in or on

canola at 0.02 ppm.

VII. 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–301048 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 November 27, 2000.

1.Filing the request. Your objection

must specify the specific provisions in

the regulation that you object to, and the

grounds for the objections (40 CFR

178.25). If a hearing is requested, the

objections must include a statement of

the factual issues(s) on which a hearing

is requested, the requestor’s contentions

on such issues, and a summary of any

evidence relied upon by the objector (40

CFR 178.27). Information submitted in

connection with an objection or hearing

request may be claimed confidential by

marking any part or all of that

information as CBI. Information so

marked will not be disclosed except in

accordance with procedures set forth in

40 CFR part 2. A copy of the

information that does not contain CBI

must be submitted for inclusion in the

public record. Information not marked

confidential may be disclosed publicly

by EPA without prior notice.

Mail your written request to: Office of

the Hearing Clerk (1900), Environmental

Protection Agency, 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 VII.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 the docket control

number OPP–301048, 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 file

format or ASCII file format. Do not

include any CBI in your electronic copy.

You may also submit an electronic copy

of your request at many Federal

Depository Libraries.

B. When Will the Agency Grant a

Request for a Hearing?

A request for a hearing will be granted

if the Administrator determines that the

material submitted shows the following:

There is a genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

VIII. Regulatory Assessment

Requirements

This final rule establishes a time

limited tolerance under FFDCA section

408. The Office of Management and

Budget (OMB) has exempted these types

of actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). This final rule does

not contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44

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

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA) (Public

Law 104–4). Nor does it require any

prior consultation as specified by

Executive Order 13084, entitled

Consultation and Coordination with

Indian Tribal Governments (63 FR

27655, May 19, 1998); special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low- Income

Populations (59 FR 7629, February 16,

1994); or require OMB review or any

57972 Federal Register / Vol. 65, No. 188 / Wednesday, September 27, 2000 / Rules and Regulations

Agency action under Executive Order

13045, entitled Protection of Children

from Environmental Health Risks and

Safety Risks (62 FR 19885, April 23,

1997). This action does not involve any

technical standards that would require

Agency consideration of voluntary

consensus standards pursuant to section

12(d) of the National Technology

Transfer and Advancement Act of 1995

(NTTAA), Public Law 104–113, section

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

tolerances and exemptions that are

established on the basis of a FIFRA

section 18 petition under FFDCA

section 408, such as the tolerance in this

final rule, do not require the issuance of

a proposed rule, the requirements of the

Regulatory Flexibility Act (RFA) (5

U.S.C. 601 et seq.) do not apply. In

addition, the Agency has determined

that this action will not have a

substantial direct effect on States, on the

relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government, as specified in

Executive Order 13132, entitled

Federalism (64 FR 43255, August 10,

1999). Executive Order 13132 requires

EPA to develop an accountable process

to ensure ‘‘meaningful and timely input

by State and local officials in the

development of regulatory policies that

have federalism implications.’’ ‘‘Policies

that have federalism implications’’ is

defined in the Executive Order to

include regulations that have

‘‘substantial direct effects on the States,

on the relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government.’’ This final rule

directly regulates growers, food

processors, food handlers and food

retailers, not States. This action does not

alter the relationships or distribution of

power and responsibilities established

by Congress in the preemption

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

IX. 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: September 12, 2000.

Susan B. Hazen,

Acting Director, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180 — [AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

371.

2. Section 180.563 is added to read as

follows:

§ 180.563 Ethametsulfuron- methyl;

tolerances for residues.

(a)General. [Reserved]

(b)Section 18 emergency exemptions.

A time-limited tolerance is established

for ethametsulfuron-methyl (Methyl 2-

(((((4-ethoxy-6- (methylamino)-1,3,5-

triazin-2-yl)amino)carbonyl)

amino)sulfonyl)benzoate) in or on

canola in connection with the use of the

pesticide under section 18 exemptions

granted by EPA. The time-limited

tolerance will expire on the date

specified in the following table:

Commodity Parts per

million

Expiration/

Revocation

Date

Canola 0.02 12/31/01

(c)Tolerances with regional

registrations. [Reserved]

(d)Indirect of inadvertent residues.

[Reserved]

[FR Doc. 00–24784 Filed 9–26–00; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301047; FRL–6744–4]

RIN 2070–AB78

Bifenthrin; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time–limited tolerance for residues of

bifenthrin in or on potato. This action

is in response to EPA’s granting of

emergency exemptions under section 18

of the Federal Insecticide, Fungicide,

and Rodenticide Act authorizing use of

the pesticide on potatoes. This

regulation establishes a maximum

permissible level for residues of

bifenthrin in this food commodity. The

tolerance will expire and is revoked on

December 31, 2002.

DATES: This regulation is effective

September 27, 2000. Objections and

requests for hearings, identified by

docket control number OPP–301047,

must be received by EPA on or before

November 27, 2000.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, in person, or by courier. Please

follow the detailed instructions for each

method as provided in Unit VII. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301047 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Andrea Conrath, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number:(703) 308–9356; and e-mail

address:beard.andrea@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially 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