58080 Federal Register / Vol. 65, No. 188 / Wednesday, September 27, 2000 / Notices

B. Toxicological Profile

Since dimethylether (DME) exists as a

gas at room temperature and any

exposure to humans would occur via

inhalation, all toxicity testing conducted

with DME was done via inhalation or in

the vapor phase.

1. Acute toxicity. An acute inhalation

toxicity study was conducted in rats.

The 4–hr LC50 was determined to be

164,000 parts per million (ppm), EPA

category IV.

2. Genotoxicty—i. An in vitro Ames/

Salmonella mutagenicity assay in five

commonly used strains was negative for

mutagenic potential.

ii. An in vitro chromosomal aberration

test in cultured human lymphocytes

was negative for chromosomal

aberrations.

3. Reproductive and developmental

toxicity—i. Reproductive organs in male

and female rats were examined

histopathologically following inhalation

of 0, 2,000, 10,000, or 25,000 ppm DME

for 6, 12, 16, and 24 months. The no

observed adverse effect level (NOAEL)

in this study was 25,000 ppm as no

compound-related effects on the

reproductive organs of either male or

female rats were observed.

ii. Developmental toxicity testing was

conducted in rats exposed via

inhalation to DME during days 6–15 of

gestation. Fetal body weight (bwt) was

decreased at the 20,000 and 40,000 ppm

levels (of borderline statistical

significance in the 20,000 ppm group)

and there was an increased incidence of

several skeletal variations (partial rib

development in the lumbar region and

partial or complete doubling of one or

more vertebral centra). The NOAEL for

the conceptus was 1,250 ppm. In

comparison to maternal effect levels,

DME was not demonstrated to represent

a unique hazard to the rat conceptus.

4. Subchronic toxicity. Male and

female Wistar rats were exposed to 0,

200, 2,000, or 20,000 ppm DME via

inhalation for 30 weeks. At the 20,000

ppm level, male rats showed a

significant reduction in liver weight

accompanied by raised serum glutamic

pyruvic transaminase (SGPT) levels. In

the 20,000 ppm females, there was no

significant effect on liver weight but

SGPT levels were raised. The NOAEL in

this study was 2,000 ppm.

5. Chronic toxicity. A 2–year DME

inhalation study was conducted in rats

for 6 hours/day, 5 days/week at

concentrations of 0, 2,000, 10,000, or

25,000 ppm. The NOAEL was 2,000

ppm based on an increase in bwt and a

decrease in survival in male rats

exposed to 10,000 or 25,000 ppm DME

vapors and on hemolytic effects noted

in male rats exposed to 25,000 ppm

DME vapors for 6 months. No neoplastic

lesions were observed that could be

attributable to DME exposure. DME was

not carcinogenic.

6. Animal metabolism. Dimethylether

is a volatile, stable compound. While no

metabolism studies were identified, the

primary route of DME elimination from

the body is likely to be exhalation of

parent compound.

7. Endocrine disruption. No adverse

endocrine effects have been suggested or

reported in any toxicity tests conducted

with DME.

C. Aggregate Exposure

1. Dietary exposure. Dimethylether

exists as a vapor at atmospheric

pressure and ambient temperatures. It is

handled and contained in aerosol

products as a liquefied gas under its

own vapor pressure which is 63 psig at

70°F. Upon release from container

pressure, as when product is dispensed,

dimethylether vaporizes completely

with essentially no residue.

Dimethylether is intended as an inert

ingredient and propellant for pesticide

formulations applied in food handling

areas and establishments; these

products are not intended for direct

application to foods. Dietary exposure

from use of dimethylether in these types

of products is believed to be minimal,

as discussed in food and drinking water

below.

i. Food. Based on its physical

properties, when dimethylether is used

as a propellant in pesticide formulations

applied in food handling areas and

establishments, no residue is expected

on or in food. Upon dispensing the

insect control product, the

dimethylether will vaporize and

dissipate quickly, affording no residue

or accumulation.

ii. Drinking water. Similarly, since

dimethylether will vaporize completely

at ambient conditions, no accumulation

is expected in drinking water. There

would be no liquid dimethylether to

migrate to groundwater aquifers or

surface water bodies that may serve as

suitable drinking water sources.

2. Non-dietary exposure. The greatest

potential for residential exposure to

dimethylether would be via inhalation

routes. However, even when these

pesticide products are used in small

areas, estimated dimethylether levels

will be lower and of much shorter

duration than recognized and accepted

levels that are considered safe for

chronic lifetime exposures.

Additionally, tests have shown that

such aerosol propellants dissipate

within minutes of use.

D. Cumulative Effects

There is no reliable information that

would indicate or suggest that

dimethylether has any toxic effect on

mammals that would be cumulative

with those of any other chemical.

E. Safety Determination

1. U.S. population. Since potential

dietary exposures are expected to be

minimal, if any, and since potential

inhalation exposures are estimated

much lower than recognized and

accepted levels considered safe for

chronic lifetime exposures,

dimethylether is not likely to pose any

significant risk to the general U.S.

population.

2. Infants and children. To the best of

our knowledge, there is no information

that suggests infants and children are

more susceptible to exposure to or

effects of dimethylether. The lack of

significant toxicity in reproductive/

developmental studies on dimethylether

suggests that growing organisms are not

at increased risks. Since potential

dietary exposures to infants and

children are minimal, if any, based on

anticipated use, it is unlikely that any

significant risks exist. Direct exposures

to infants and children via inhalation

are not anticipated for the intended use

of dimethylether.

F. International Tolerances

DuPont is not aware of any tolerances

for dimethylether outside the United

States.

[FR Doc. 00–24438 Filed 9–26–00; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[PF–977; FRL–6746–4]

Notice of Filing Pesticide Petitions to

Establish a Tolerance for Certain

Pesticide Chemicals in or on Food

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

initial filing of pesticide petitions

proposing the establishment of

regulations for residues of certain

pesticide chemicals in or on various

food commodities.

DATES: Comments, identified by docket

control number PF–977, must be

received on or before October 27, 2000.

ADDRESSES: Comments may be

submitted by mail, electronically, or in

person. Please follow the detailed

instructions for each method as

Federal Register / Vol. 65, No. 188 / Wednesday, September 27, 2000 / Notices 58081

provided in Unit I.C. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, it is imperative

that you identify docket control number

PF–977 in the subject line on the first

page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: For Pesticide Petition PP (0E6118),

contact Shaja R. Brothers, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 308–3194; e-mail address:

brothers.shaja@epa.gov.

For Pesticide Petition PP (0F6146),

contact Thomas C. Harris, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 308–9423; e-mail address:

harris.thomas@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer or pesticide manufacturer.

Potentially affected categories and

entities may include, but are not limited

to:

Categories NAICS

codes

Examples of potentially affected

entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations,’’ ‘‘Regulations

and Proposed Rules,’’ and then look up

the entry for this document under the

‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/.

2. In person. The Agency has

established an official record for this

action under docket control number PF–

977. The official record consists of the

documents specifically referenced in

this action, any public comments

received during an applicable comment

period, 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 Highway,

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.

C. How and to Whom Do I Submit

Comments?

You may submit comments through

the mail, in person, or electronically. To

ensure proper receipt by EPA, it is

imperative that you identify docket

control number PF–977 in the subject

line on the first page of your response.

1. By mail. Submit your comments to:

Public Information and Records

Integrity Branch (PIRIB), Information

Resources and Services Division

(7502C), Office of Pesticide Programs

(OPP), Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460.

2. In person or by courier. Deliver

your comments to: Public Information

and Records Integrity Branch (PIRIB),

Information Resources and Services

Division (7502C), Office of Pesticide

Programs (OPP), Environmental

Protection Agency, Rm. 119, Crystal

Mall #2, 1921 Jefferson Davis Highway,

Arlington, VA. The PIRIB is open from

8:30 a.m. to 4 p.m., Monday through

Friday, excluding legal holidays. The

PIRIB telephone number is (703) 305–

5805.

3. Electronically. You may submit

your comments electronically by e-mail

to: opp-docket@epa.gov, or you can

submit a computer disk as described

above. Do not submit any information

electronically that you consider to be

CBI. Avoid the use of special characters

and any form of encryption. Electronic

submissions will be accepted in

Wordperfect 6.1/8.0 or ASCII file

format. All comments in electronic form

must be identified by docket control

number PF–977. Electronic comments

may also be filed online at many Federal

Depository Libraries.

D. How Should I Handle CBI That I

Want to Submit to the Agency?

Do not submit any information

electronically that you consider to be

CBI. You may claim information that

you submit to EPA in response to this

document as CBI 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.

In addition to one complete version of

the comment that includes any

information claimed as CBI, a copy of

the comment that does not contain the

information claimed as CBI must be

submitted for inclusion in the public

version of the official record.

Information not marked confidential

will be included in the public version

of the official record without prior

notice. If you have any questions about

CBI or the procedures for claiming CBI,

please consult the person identified

under FOR FURTHER INFORMATION

CONTACT.

E. What Should I Consider as I Prepare

My Comments for EPA?

You may find the following

suggestions helpful for preparing your

comments:

1. Explain your views as clearly as

possible.

2. Describe any assumptions that you

used.

3. Provide copies of any technical

information and/or data you used that

support your views.

4. If you estimate potential burden or

costs, explain how you arrived at the

estimate that you provide.

5. Provide specific examples to

illustrate your concerns.

6. Make sure to submit your

comments by the deadline in this

notice.

7. To ensure proper receipt by EPA,

be sure to identify the docket control

number assigned to this action in the

subject line on the first page of your

response. You may also provide the

58082 Federal Register / Vol. 65, No. 188 / Wednesday, September 27, 2000 / Notices

name, date, and Federal Register

citation.

II. What Action is the Agency Taking?

EPA has received pesticide petitions

as follows proposing the establishment

and/or amendment of regulations for

residues of certain pesticide chemicals

in or on various food commodities

under section 408 of the Federal Food,

Drug, and Comestic Act (FFDCA), 21

U.S.C. 346a. EPA has determined that

these petitions contain data or

information regarding the elements set

forth in section 408(d)(2); however, EPA

has not fully evaluated the sufficiency

of the submitted data at this time or

whether the data support granting of the

petitions. Additional data may be

needed before EPA rules on the

petitions.

List of Subjects

Environmental protection,

Agricultural commodities, Feed

additives, Food additives, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: September 15, 2000.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

Summaries of Petitions

Petitioners summaries of the pesticide

petitions are printed below as required

by section 408(d)(3) of the FFDCA. The

summaries of the petitions were

prepared by the petitioners and

represent the views of the petitioners.

The petitions summaries announces the

availability of a description of the

analytical methods available to EPA for

the detection and measurement of the

pesticide chemical residues or an

explanation of why no such method is

needed.

Interregional Research Project Number

4

Novartis Crop Protection Inc.

0E6118 and 0F6146

EPA has received a pesticide petition

(0E6118) from Interregional Research

Project Number 4, 681 U.S. Highway #1

South, North Brunswick NJ 08902–3390.

EPA has also received a pesticide

petition (PP 0F6146) from Novartis Crop

Protection Inc., Post Office Box 18300,

Greensboro NC 27419–8300. These

petitions propose, pursuant to section

408(d) of the FFDCA, 21 U.S.C. 346a(d),

to amend 40 CFR part 180 by

establishing tolerances for residues of

the insecticide, avermectin ( a mixture

of avermectins containing greater than

or equal to 80% avermectin B1a (5-Odemethyl avermectin A1) and less than

or equal to 20% avermectin B1b (5-Odemethyl-25-de(1-methylethyl)

avermectin A1)) and its delta 8,9–isomer

in or on the food commodities at the

tolerance level as follows:

1. PP 0E6118, which was submitted

by IR–4, proposes the establishment of

a tolerance for celeriac (roots and tops)

at 0.05 parts per million (ppm).

2. PP 0F6146, which was submitted

by Novartis Crop Protection Inc.,

proposes the establishment of tolerances

for avocado at 0.02 ppm, grass forage at

0.001 ppm, grass hay at 0.001 ppm,

stone fruit crop group at 0.015 ppm,

mint tops at 0.01 ppm, tree nut crop

group and pistachios at 0.005 ppm, and

the tuberous and corm vegetables crop

subgroup at 0.005 ppm.

A. Residue Chemistry

1. Plant metabolism. The metabolism

of abamectin in plants is adequately

understood and the residues of concern

include the parent insecticide,

abamectin or avermectin B1 (which is a

mixture of a minimum of 80%

avermectin B1a and a maximum of 20%

avermectin B1b) and the delta 8,9–

isomer of the B1a and of the B1b

components of the parent insecticide.

2. Analytical method. The analytical

methods involves homogenization,

filtration, partition, and cleanup with

analysis by high performance liquid

chromotography (HPLC)-fluorescence

detection. The methods are sufficiently

sensitive to detect residues at or above

the tolerances proposed. All methods

have undergone independent laboratory

validation as required by PR Notice 88–

5.

3. Magnitude of residues. Complete

residue data for abamectin for the

petitioned tolerances has been

submitted. The data support the

requested tolerances.

B. Toxicological Profile

1. Acute toxicity. The data base

includes the following studies:

i. A rat acute oral study with a lethal

dose (LD)50 of 4.4 to 11.8 mg/kg (males)

and 10.9 to 14.9 milligrams/kilograms

(mg/kg) (females).

ii. An acute oral toxicity in the CF–

1 mouse with the delta 8,9–isomer has

LD50 greater than 80 mg/kg.

iii. A rabbit acute dermal study with

a LD50 >2,000 mg/kg.

iv. A rat acute inhalation study with

a LC50 >5.73 mg/L.

v. A primary eye irritation study in

rabbits which showed irritation.

vi. A primary dermal irritation study

in rabbits which showed no irritation.

vii. A primary dermal sensitization

study in guinea pigs which showed no

skin sensitization potential.

viii. An acute oral toxicity study in

monkeys with a no observed adverse

effect level (NOAEL) of 1.0 mg/kg based

upon emesis at 2.0 mg/kg.

2. Genotoxicity. The Ames assays

conducted with and without metabolic

activation were both negative. The V–79

mammalian cell mutagenesis assays

conducted with and without metabolic

activation did not produce mutations. In

an alkaline elution/rat hepatocyte assay,

abamectin was found to induce single

strand DNA breaks without significant

toxicity in rat hepatocytes treated in

vitro at doses greater than 0.2 mM. This

in vitro dose of 0.2 mM is biologically

unobtainable in vivo, due to the toxicity

of the compound. However, at these

potentially lethal doses, in vivo

treatment did not induce DNA single

strand breaks in hepatocytes. In the

mouse bone marrow assay, abamectin

was not found to induce chromosomal

damage. There are also many studies

and a great deal of clinical and followup experience with regard to

ivermectin, a closely similar human and

animal drug.

3. Reproductive and developmental

toxicity. In a 2–generation study in rats

the NOAEL was established at 0.12 mg/

kg/day in pups based upon retinal folds,

decreased body weight (bwt), and

mortality. The NOAELs for systemic and

reproductive toxicity were 0.4 mg/kg/

day. In the 2–generations reproduction

study in rats with the delta 8,9–isomer,

the NOAEL was 0.4 mg/kg/day and the

lowest observed adverse effect level

(LOAEL) was greater than 0.4 mg/kg/day

highest dose tested (HDT).

In an oral developmental toxicity

study in the CF–1 mouse the maternal

NOAEL was 0.05 mg/kg/day based upon

decreased bwts and tremors. The fetal

NOAEL was 0.20 mg/kg/day based upon

cleft palates. In an oral developmental

toxicity study with the delta 8,9–isomer

in CF–1 mice the maternal NOAEL was

0.10 mg/kg/day based upon decreased

bwts. The fetal NOAEL was 0.06 mg/kg/

day based upon cleft palate. In an oral

developmental toxicity study in rabbits

the maternal NOAEL was 1.0 mg/kg/day

based upon decreased bwts and tremors.

The fetal NOAEL was 1.0 mg/kg/day

based upon clubbed feet. In an oral

developmental toxicity study in rats the

maternal and fetal NOAEL was 1.6 mg/

kg/day, the HDT. In an oral

developmental toxicity study with the

delta 8,9–isomer the maternal NOAEL

in CF–1 mice that expressed Pglycoprotein was greater than 1.5 mg/

kg/day, the highest and only dose

tested. No cleft palates were observed in

fetuses that expressed normal levels of

P-glycoprotein, but fetuses with low or

Federal Register / Vol. 65, No. 188 / Wednesday, September 27, 2000 / Notices 58083

no levels of P-glycoprotein had

increased incidence of cleft palates.

4. Subchronic toxicity. Subchronic

toxicity studies included the following:

i. A rat 8–week feeding study with a

NOAEL of 1.4 mg/kg/day based upon

tremors.

ii. A rat 14–week oral toxicity study

with a NOAEL of 0.4 mg/kg/day, the

HDT.

iii. A dog 12–week feeding study with

a NOAEL of 0.5 mg/kg/day based upon

mydriasis.

iv. A dog 18–week oral study with a

NOAEL of 0.25 mg/kg/day based upon

mortality.

v. A. CD–1 mouse 84–day feeding

study with a NOAEL of 4 mg/kg/day

based upon decreased bwts.

5. Chronic toxicity. A rat 53–week

carcinogencity feeding study was

negative for carcinogencity, with a

NOAEL of 1.5 mg/kg/day based upon

tremors. A CD–1 mouse 94–week

carcinogencity feeding study was

negative for carcinogencity, with a

NOAEL of 4 mg/kg/day based upon

decreased bwts. A dog 53–week chronic

feeding study was negative for

carcinogencity, with a NOAEL of 0.25

mg/kg/day based upon mydriasis.

6. Animal metabolism. Rats were

given oral doses of 0.14 or 1.4 mg/kg

bwt/day of abamectin or 1.4 mg/kg bwt/

day of the delta–8,9 isomer. Over 7

days, the percentages excreted in urine

were 0.3–1% of the administered dose

of abamectin and 0.4% of the dose of

the isomer. The animals eliminated 69–

82% of the dose of abamectin and 94%

of the dose of isomer in feces. In rats,

goats, and cattle, unchanged parent

compound accounted for up to 50% of

the total radioactive residues in tissues.

The 24–hydroxymethyl derivative of

abamectin was found in rats, goats, and

cattle treated with the compound and in

rats treated with the delta–8,9 isomer,

and the 3’’-O-demethyl derivative was

found in rats and cattle administered

abamectin and in rats administered the

isomer.

7. Metabolite toxicology. There are no

metabolites of concern based on a

differential metabolism between plants

and animals. The potential hazard of the

24–hydroxymethyl or the 3’’-Odemethyl animal metabolites was

evaluated in through toxicology studies

with abamectin photolytic break-down

product, the delta 8,9–isomer.

8. Endocrine disruption. There is no

evidence that abamectin is an endocrine

disrupter. Evaluation of the rat multigenerational study demonstrated no

effect on the time to mating or on the

mating and fertility indices, suggesting

no effects on the estrous cycle, on

mating behavior, or on male or female

fertility at doses up to 0.4 mg/kg/day,

the HDT. Furthermore, the range finding

study demonstrated no adverse effect on

female fertility at doses up to 1.5 mg/kg/

day, the HDT. Similarly, chronic and

subchronic toxicity studies in mice, rats,

and, dogs did not demonstrate any

evidence of toxicity to the male or

female reproductive tract, or to the

thyroid or pituitary (based upon organ

weights and gross and histopathologic

examination). In the developmental

studies, the pattern of toxicity observed

does not seem suggestive of any

endocrine effect. Finally, experience

with ivermectin in breeding animals,

including sperm evaluations in multiple

species, shows no adverse effects

suggestive of endocrine disruption.

C. Aggregate Exposure

1. Dietary exposure—i. Food. An

acute assessment was conducted for

avermectin B1a and B1b residues using

the Dietary Exposure Evaluation Model

(DEEMTM) and food consumption

information from United State

Department of Agriculture’s (USDA)’s

1994–1996 continuing survey of food

intake by individuals (CSFII). Acute

dietary exposure to the adult male

subpopulation was compared to an

acute reference dose (RfD) of 0.0025 mg/

kg/day based on a NOAEL of 0.25 mg/

kg/day from a 1–year dog study and a

100X uncertainty factor (UF). For all

other populations (containing females,

infants and children) an acute

population adjusted dose (PAD) of

0.00083 mg/kg/day was used and

reflects an appropriate 300X UF. This

tier 3 probabilistic analysis included the

entire distribution of field trial residues

and percent of crop treated information

was incorporated by adding zeroes into

the residue distribution file (RDF)

representing the percent of crop not

treated. Non-detected residues of

avermectin B1a were entered into the

software as 1/2 the limit of quantitation

(1/2 (LOQ)) and non-detected residues

of avermectin B1b were entered in as 1/

4 LOQ since the production ratio of B1a:

B1b is 80:20. The acute dietary exposure

results for the male (20 + years)

population shows that 2.6% of the acute

RfD was utilized at the 99.9th percentile

of exposure. For the general U.S.

population at the 99.9th percentile,

exposure was 13.2% of the acute PAD.

The most sensitive subpopulation was

non-nursing infants (< 1–year old) with

39.3% of the acute PAD at the 99.9th

percentile.

For the male subpopulation, chronic

exposure was compared to the chronic

RfD of 0.0012 mg/kg/day from a 2–

generation reproduction study in rats

and a 100X UF. A 300X UF was utilized

for populations containing females (13 +

years old) and infants and children and

the exposures were compared to a PAD

of 0.0004 mg/kg/day. Residue values,

taken from field trials conducted at

maximum application rates and

minimum pre-harvest intervals (PHI),

were averaged and incorporated into the

assessment. Residue values were

adjusted with percent of crop treated

information. For the male population

(both 13–19 years and 20 + years),

exposure was 0.3% of the chronic RfD.

The chronic exposure results indicate

that the U.S. population utilizes 1.3% of

the chronic PAD. The most sensitive

subpopulation was non-nursing infants

with 2.9% of the chronic PAD. These

results are conservative in that residue

values were generated from field trials

with maximum application rates and

minimum post PHI. In addition, a

significant reduction in residues would

be expected as abamectin-treated

commodities travel through food

commerce, food preparation and

storage.

ii. Drinking water. Acute exposure

The estimated maximum concentration

of abamectin in surface water is 0.88

parts per billion (ppb) (Peak estimated

environmental concentration ((EEC)

value from EPA’s Pesticide Root Zone

Model (PRZM)/EXAMS). This is an

estimated environmental concentration

based on the use of abamectin on

strawberries (the maximum use rate on

registered and proposed uses). Use rates

for crops on the current petition are all

below the maximum use rate for

strawberries. Novartis believes the

estimates of abamectin exposure in

water derived from the PRZM/EXAMS

models are significantly overstated. EPA

noted that the certainty of the

concentrations estimated for

strawberries is low, due to uncertainty

on the amount of runoff from plant beds

covered in plastic mulch and

uncertainty on the amount of

degradation of abamectin on black

plastic compared to soil. Although there

is a high degree of uncertainty to this

analysis, this is the best available

estimate of concentrations of abamectin

in drinking water.

Based on the EPA’s ‘‘Interim

Guidance for Conducting Drinking

Water Exposure and Risk Assessments’’

document (12/2/97), the acute drinking

water levels of comparison

((DWLOCacute)) were calculated for

abamectin. For the adult male

subpopulation, the DWLOCacute was

determined based on an acute RfD of

0.0025 mg/kg/day based on a NOAEL of

0.25 mg/kg/day from a 1–year dog study

and a 100X UF. For all other

populations (containing females,

58084 Federal Register / Vol. 65, No. 188 / Wednesday, September 27, 2000 / Notices

infants, and children), the DWLOCacute

was determined based on a population

adjusted dose PAD of 0.00083 mg/kg/

day and reflects an appropriate 300X

UF. The acute dietary exposure results

for the male (20 + years) population

shows an exposure estimate of 0.000066

mg/kg bwt/day at the 99.9th percentile of

exposure, thus a DWLOCacute of 85 for

this subpopulation. For the general U.S.

population at the 99.9th percentile, an

exposure estimate of 0.000110 mg/kg

bwt/day was determined, thus a

DWLOC acute of 25. The most exposed

subpopulation was non-nursing infants

(<1 year old) with an exposure estimate

of 0.000327 mg/kg bwt/day at the 99.9th

percentile, thus a DWLOCacute of 3 for

this subpopulation. Based on this

analysis, abamectin EECs do not exceed

the calculated acute DWLOCs. Based on

a maximum EEC of 0.88 ppb, acute

exposure through the consumption of

drinking water is below 19% of the

acute population adjusted dose for all

subpopulations.

Chronic exposure. The estimated

maximum concentrations of abamectin

in surface and ground water are 0.37

ppb (Mean of annual values from

PRZM/EXAMS) and 0.002 ppb

screening concentration in ground water

(SCI-GROW), respectively. These are

EECs based on the use of abamectin on

strawberries (the maximum use rate on

registered and proposed uses). Use rates

for crops on the current petition are all

below the maximum use rate for

strawberries. The chronic drinking

water levels of comparison

(DWLOCchronic) were calculated for

abamectin. For the adult male

subpopulation, the DWLOCchronic was

determined based on the chronic RfD of

0.0012 mg/kg/day from a 2–generation

reproduction study in rats and a 100X

uncertainty factor. A 300X UF was

utilized for populations containing

females (13 + years old) and infants and

children and the DWLOCchronic was

determined based on a populationadjusted dose PAD of 0.0004 mg/kg/day.

The chronic dietary exposure results for

the male (13–19 yrs and 20 + years)

population shows an exposure estimate

of 0.000004 mg/kg bwt/day, thus a

DWLOCchronic of 42 for this

subpopulation. For the general U.S.

population, an exposure estimate of

0.000005 mg/kg bwt/day was

determined, thus a DWLOCchronic of 14.

The most exposed subpopulation was

non-nursing infants (<1 year old) with

an exposure estimate of 0.000012 mg/kg

bwt/day, thus a DWLOCchronic of 2.3 for

this subpopulation. Based on this

analysis, abamectin EECs do not exceed

the calculated chronic DWLOCs. Based

on a maximum EEC of 0.37 ppb, chronic

exposure through the consumption of

drinking water is below 16% of the

chronic population adjusted dose for all

subpopulations.

2. Non-dietary exposure.

Avermectin’s registered residential uses

include indoor crack/crevice and

outdoor application to lawns. For lawn

uses, EPA conducted a risk assessment

for adult applicators and postapplication exposure to avermectin

using the EPA’s draft SOPs for

residential exposure assessments. The

highest predicted exposure, oral hand to

mouth for children, resulted in a

calculated margin of exposure (MOE) of

14,000. For children’s post-application

exposure to avermectin from indoor

crack/crevice products, valid exposure

studies demonstrate there is no

exposure and therefore no risk for

indoor residential scenarios. Short- and

intermediate-term risk for the registered

uses do not exceed EPA’s level of

concern.

i. Chronic exposure and risk. Chronic

exposures for the residential uses are

not expected.

ii. Short- and intermediate-term

exposure and risk. Risk for the

registered uses do not exceed EPA’s

level of concern.

D. Cumulative Effects

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 residue

and ‘‘other substances that have a

common mechanism of toxicity.’’ The

EPA stated in the Federal Register (FR)

document published April 7, 1999,

(Volume 64 Page 16843) (FRL-6070-6)

that it does not have, at this time,

available data to determine whether

avermectin has a common mechanism

of toxicity with other substances or how

to include this pesticide in a cumulative

risk assessment.

E. Safety Determination

1. U.S. population. Using the

exposure assumptions described above

and based on the completeness and

reliability of the toxicity data base,

Novartis has calculated aggregate

exposure levels for this chemical. The

calculations show that chronic dietary

exposure is below 100% of the RfD and

the predicted acute exposure is below

100% of the acute RfD for all

subpopulations. Chronic exposure

through the consumption of drinking

water has been estimated to be well

below any level of concern. Acute

exposure to residues of abamectin in

drinking water has been estimated to be

above the drinking water level of

comparison DWLOC for children (1-6

years old) but the certainty of this

calculation is low due to the uncertainty

on the amount of runoff from strawberry

plant beds covered in plastic mulch and

the uncertainty on the amount of

degradation of abamectin on black

plastic as compared to soil. Novartis

concludes that there is a reasonable

certainty that no harm will result from

aggregate exposure to abamectin

residues.

2. Infants and children. The food

quality protection act (Public Law 104–

170) (FQPA) authorizes the employment

of an additional safety factor of up to

10X to guard against the possibility of

prenatal or postnatal toxicity, or to

account for an incomplete data base on

toxicity or exposure. EPA has chosen to

retain the FQPA safety factor for

abamectin based on several reasons

including evidence of neurotoxicity,

susceptibility of neonatal rat pups,

similarity to ivermectin, lack of a

developmental neurotoxicity study, and

concern for exposure to infants and

children. It is the opinion of Novartis

that a 3X safety factor is more

appropriate for abamectin at this time.

EPA has evaluated abamectin repeatedly

since its introduction in 1985 and has

found repeatedly that the level of

dietary exposure is sufficiently low to

provide ample margins of safety to

guard against any potential adverse

effects of abamectin. In addition, valid

exposure studies demonstrate there is

no exposure via indoor applications of

abamectin products. Novartis states that

the data base for abamectin is complete

and that the developmental

neurotoxicity study is a new and not yet

initially required study. Additionally,

there is much more information

regarding human risk potential than is

the case with most pesticides, because

of the widespread animal-drug and

human-drug uses of ivermectin, the

closely related analog of abamectin.

It is the opinion of Novartis that the

use of a full 10X safety factor to address

risks to infants and children is not

necessary. The established chronic

endpoint for abamectin in the neonatal

rat is overly conservative. Similar

endpoints for ivermectin are not used by

the Food and Drug Administration

(FDA) to support the allowable daily

intake for ivermectin residues in food

from treated animals. No evidence of

toxicity was observed in neonatal rhesus

monkeys after 14 days of repeated

administration of 0.1 mg/kg/day HDT

and in juvenile rhesus monkeys after

repeated administration of 1.0 mg/kg/

day HDT. The comparative data on

Federal Register / Vol. 65, No. 188 / Wednesday, September 27, 2000 / Notices 58085

abamectin and ivermectin in primates

also clearly demonstrate the dose

response for exposure to either

compound is much less steep than that

seen in the neonatal rat. Single doses as

high as 24 mg/kg of either abamectin or

ivermectin in rhesus monkeys did not

result in mortality; however, this dose

was more than 2 times the LD50 in the

adult rat and more than 20 times the

LD50 in the neonatal rat. The absence of

a steep dose-response curve in primates

provides a further margin of safety

regarding the probability of toxicity

occurring in infants or children exposed

to avermectin compounds. The

significant human clinical experience

and widespread animal drug uses of

ivermectin without systemically toxic,

developmental, or postnatal effects

supports the safety of abamectin to

infants and children.

F. International Tolerances

There are no abamectin Codex

maximum residue levels for avocados,

celeriac, grass forage, grass hay, stone

fruit, mint, tree nut crop group,

pistachios and tuberous and corm

vegetables crop subgroup.

[FR Doc. 00–24575 Filed 9–26–00; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[OPP–50872; FRL–6739–9]

Issuance of Experimental Use Permits

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: EPA has granted experimental

use permits (EUPs) to the following

pesticide applicants. An EUP permits

use of a pesticide for experimental or

research purposes only in accordance

with the limitations in the permit.

FOR FURTHER INFORMATION CONTACT: By

mail: Registration Division (7505C),

Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460.

In person or by telephone: Contact the

designated person at the following

address at the office location, telephone

number, or e-mail address cited in each

experimental use permit: 1921 Jefferson

Davis Hwy., Arlington, VA.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

This action is directed to the public

in general. Although this action may be

of particular interest to those persons

who conduct or sponsor research on

pesticides, the Agency has not

attempted to describe all the specific

entities that may be affected by this

action. If you have any questions

regarding the information in this action,

consult the designated contact person

listed for the individual EUP.

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

You may obtain electronic copies of

this document from the EPA Internet

Home Page at http://www.epa.gov/. 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/.

II. EUPs

EPA has issued the following EUPs:

11312–EUP–105. Issuance.

Agricultural Research Service (ARS) of

the U.S. Department of Agriculture

(USDA), Beltsville, MD 20705. This EUP

allows the use of 26 pounds of the

insecticide Phloxine B on 200 acres of

field corn to evaluate the control of

northern, southern, western, and

mexican corn rootworms. The program

is authorized only in the States of

Nebraska and South Dakota. The EUP is

effective from August 1, 2000 to October

1, 2000. The Agency considers this EUP

to be non-food/non-feed because of the

low use rate (1–2 oz per acre), the site

of application (outer shucks of the corn),

type of harvesting (mechanical

harvesting and separation of shucks

from ear), and composting of the shucks

in the ground following application of

product. (Daniel Peacock; Rm. 223,

Crystal Mall #2; telephone number:

(703) 305–5407; e-mail address:

peacock.dan@epa.gov).

62719–EUP–44. Amendment. Dow

AgroSciences LLC, 9330 Zionsville Rd.,

Indianapolis, IN 46268–1054. This

experimental use permit allows the use

of 3,379,758 pounds of the soil

fumigants 1,3-dichloropropene and

chloropicrin from the product InLine on

15,000 acres of soil, treated using drip

irrigations systems only, to be planted to

the commodities cauliflower,

cucumbers, eggplant, lettuce, melons,

onions, peppers, pineapples, squash,

strawberries, and tomatoes to evaluate

the control of nematodes, symphylans

and certain soil-borne diseases. The

program is authorized only in the States

of Alabama, Arizona, California,

Colorado, Delaware, Florida, Georgia,

Hawaii, Idaho, Michigan, New Jersey,

New Mexico, North Carolina, Oregon,

South Carolina, Texas, Virginia, and

Washington. The experimental use

permit is effective from June 25, 1999 to

June 25, 2002. (Mary L. Waller, Product

Manager (21); Rm. 249, Crystal Mall #2;

telephone number: (703) 308–9354; email address: waller.mary@epa.gov).

62719–EUP–46. Issuance. Dow

AgroSciences LLC, 9330 Zionsville Rd.,

Indianapolis, IN 46268–1054. This

experimental use permit allows the use

of 237,350 pounds of the nematicide

1,3-dichloropropene on 5,000 acres of

golf course turf to evaluate the control

of plant parasitic nematodes. The

program is authorized only in the State

of Florida. The experimental use permit

is effective from August 28, 2000 to

August 28, 2001. (Mary L. Waller; Rm.

249, Crystal Mall #2; telephone number:

(703) 308–9354; e-mail address:

waller.mary@epa.gov).

Persons wishing to review these EUPs

are referred to the designated contact

person. Inquiries concerning these

permits should be directed to the

persons cited above. It is suggested that

interested persons call before visiting

the EPA office, so that the appropriate

file may be made available for

inspection purposes from 8 a.m. to 4

p.m., Monday through Friday, excluding

legal holidays.

Authority: 7 U.S.C. 136.

List of Subjects

Environmental protection,

Experimental use permits.

Dated: September 18, 2000.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

[FR Doc. 00–24679 Filed 9–26–00; 8:45 am]

BILLING CODE 6560–50–S

FEDERAL MARITIME COMMISSION

Notice of Agreement(s) Filed

The Commission hereby gives notice

of the filing of the following

agreement(s) under the Shipping Act of

1984. Interested parties can review or

obtain copies of agreements at the

Washington, DC offices of the

Commission, 800 North Capitol Street,

N.W., Room 962. Interested parties may

submit comments on an agreement to

the Secretary, Federal Maritime

Commission, Washington, DC 20573,

within 10 days of the date this notice

appears in the Federal Register.

Agreement No.: 011560–002.