65950 Federal Register / Vol. 66, No. 246 / Friday, December 21, 2001 / Notices

ENVIRONMENTAL PROTECTION

AGENCY

[PF–1063; FRL–6814–1]

Notice of Filing a Pesticide Petition to

Establish a Tolerance for a Certain

Pesticide Chemical in or on Food

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

initial filing of a pesticide petition

proposing the establishment of

regulations for residues of a certain

pesticide chemical in or on various food

commodities.

DATES: Comments, identified by docket

control number PF–1063, must be

received on or before January 22, 2002.

ADDRESSES: Comments may be

submitted by mail, electronically, or in

person. Please follow the detailed

instructions for each method as

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–1063, in the subject line on the first

page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Hoyt Jamerson, Registration

Support Branch, Registration Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: (703)

308–9368; e-mail address:

jamerson.hoyt@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’’ 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–

1063. 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–1063, 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–1063. 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.

Federal Register / Vol. 66, No. 246 / Friday, December 21, 2001 / Notices 65951

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

name, date, and Federal Register

citation.

II. What Action is the Agency Taking?

EPA has received a pesticide petition

as follows proposing the establishment

and/or amendment of regulations for

residues of a certain pesticide chemical

in or on various food commodities

under section 408 of the Federal Food,

Drug, and Cosmetic Act (FFDCA), 21

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

this petition contains 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

petition. Additional data may be needed

before EPA rules on the petition.

List of Subjects

Environmental protection,

Agricultural commodities, Feed

additives, Food additives, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: December 12, 2001.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

Summary of Petition

The petitioner summary of the

pesticide petition is printed below as

required by section 408(d)(3) of the

FFDCA. The summary of the petition

was prepared by BASF Corporation,

Agricultural Products, 26Davis Drive,

Research Triangle Park, NC 27709 and

represents the view of BASF

Corporation. EPA is publishing the

petition summary verbatim without

editing it in any way. The petition

summary 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

PP 0E6209

EPA has received a pesticide petition

0E6209 from the Interregional Research

Project Number 4 (IR-4), 681 U.S.

Highway #1 South, North Brunswick, NJ

08902-3390 proposing, pursuant to

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

346a(d), to amend 40 CFR part 180 by

establishing a tolerance for residues of

(3,6-dichloro-o-anisic acid (dicamba) in

or on the raw agricultural commodities

(RAC): Corn, sweet, kernel plus cob

with husks removed at 0.04 part per

million (ppm); corn, sweet, forage at

0.50 ppm; and corn, sweet, stover at

0.50 ppm. EPA has determined that the

petition contains data or information

regarding the elements set forth in

section 408(d)(2) of the FFDCA;

however, EPA has not fully evaluated

the sufficiency of the submitted data at

this time or whether the data support

granting of the petition. Additional data

may be needed before EPA rules on the

petition.

A. Residue Chemistry

1. Plant metabolism. The metabolism

is adequately understood on the basis of

soybean, asparagus, cotton, sugarcane,

and published data on grass. In the

majority of registered crops, the major

metabolite is the 3,6-dichloro-5-OH-oanisic acid. Tolerances are expressed as

the dicamba parent plus the respective

major metabolite.

2. Analytical method. BASF Corp. has

provided suitable independently

validated analytical methods for

detecting and measuring levels of

dicamba, and its metabolites in or on

food with a limit of detection that

allows monitoring of food with residues

at or above the levels described in these

and the existing tolerances. Adequate

methods are available in PAM-II for

enforcement purposes. The analytical

method involves extraction, partition,

clean-up and detection of residues by

gas chromatography/electron capture

detector (gc/ecd).

3. Magnitude of residues. Residue

trials have been conducted with

dicamba/diflufenzopyr end-use product

distinct on the sweet corn crop for

expanded use requested in the subject

petition. The tolerances listed below are

based on the maximum expected

residue from geographically

representative field trial data: Proposed

tolerances for combined residues of the

herbicide dicamba (3,6-dichloro-o-anisic

acid) and its metabolite 3,6-dichloro-5-

hydroxy-o-anisic acid in or on the RAC

as follows (40 CFR 180.227(a)): Corn,

sweet, kernel plus cob with husks

removed at 0.04 ppm; corn, sweet,

forage at 0.05 ppm; and corn, sweet,

stover at 0.05 ppm.

4. Animal residue. The uses proposed

do not yield secondary residues in meat,

and milk above the tolerances already

published under 40 CFR 180.227. Data

from metabolism and feeding studies in

poultry have established that the

maximum expected dietary burden from

crops treated with dicamba, will not

result in quantifiable residues above the

limits of the analytical method.

B. Toxicological Profile

1. Acute toxicity. Oral rat LD50: 1,879

milligrams/kilograms (mg/kg) (m) and

1,581 mg/kg (f). Acute dermal rat LD50:

> 2,000 kg/kg (m/f). Acute inhalation rat

LC50: > 9.6 mg/L (m/f). Primary eye

irritation: Extremely irritating and

corrosive to the eye. Primary dermal

irritation rabbits: Not a primary skin

irritant. Dermal sensitization guinea

pigs: Moderate potential to cause dermal

sensitization. Acute neurotoxicity: No

observed adverse levels (NOAEL) < 300

mg/kg (low dose). No neuropathological

effects were found.

2. Genotoxicity. Ames: Negative. In

vitro chromosome aberration in Chinese

Hamster Ovary: Negative. Sex-linked

recessive lethal in Drosophila: Negative.

Aberrations in rat bone marrow:

Negative. Mitotic recombination:

Negative. UDH Unscheduled DNA

synthesis (UDS) with WI-38) human

lung fibroblasts: Negative. Differential

toxicity with E. coli pol A and B.

subtillus: Positive. Differential toxicity

with S. typhimurium: Negative. UDS in

human lung lymphocytes with

activation: Negative; slight increase of

sister chromatid exchange in human

cultured lymphocytes; positive in in

vivo unwinding of liver DNA Inhalable

Particles (in ip) injected rats.

3. Reproductive and developmental

toxicity. Rodent developmental toxicity

rat: Oral doses of 0, 64, 160, or 400 mg/

kg were administered daily during

gestation days 6 to 19. The numbers of

implantations, resorptions, and fetuses

for test animals were similar to those

numbers for control animals. No

abnormalities were attributed to

exposure to dicamba. Technical

dicamba was not found to be teratogenic

with the test system/study design

employed. Maternal toxicity was found

only at the highest dose tested (HDT)

and the NOAEL was 160 mg/kg/day.

i. Rabbit developmental toxicity.

Dicamba was administered orally

(undiluted) via capsule to groups of 20

artificially inseminated New Zealand

White rabbits. Dose levels of 0, 30, 150,

or, 300 mg/kg were administered once

daily on days 6–18 of presumedVerDate 11<MAY>2000 18:41 Dec 20, 2001 Jkt 197001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 E:\FR\FM\21DEN1.SGM pfrm11 PsN: 21DEN1
65952 Federal Register / Vol. 66, No. 246 / Friday, December 21, 2001 / Notices

gestation (day 0 = day of insemination).

Females were sacrificed on day 29 of

presumed gestation. There were no

deaths attributed to treatment. At the

150 mg/kg and 300 mg/kg levels,

increased numbers of does with

decreased motor activity and

statistically significant numbers of does

with ataxia were noted. At 300 mg/kg,

a significant number of does had rales

and an increased number of does

showed labored breathing, perinasal

substance, dried feces, impaired righting

reflex, and red substance in the cage

pan. These clinical observations were

considered to be effects of treatment.

Females in the 300 mg/kg group had

statistically significant body weight loss

for the entire dosage period. At 150 mg/

kg, females lost weight on day 7 and 8

of presumed gestation. Although,

compensatory weight gains occurred

during the post-treatment period (days

19–29 of gestation), body weight gains

remained statistically significantly

reduced on days 6–29 of gestation in the

300 mg/kg group. No significant

differences were obtained in litter

averages forcorpora lutea, implants,

litter sizes, resorption sites, percent

male fetuses, fetal body weight, percent

resorbed conceptuses or number of does

with any resorptions. No gross external,

soft tissue or skeletal alterations in

fetuses were considered to be related to

treatment. The maternal NOAEL for

technical dicamba to pregnant rabbits

was 30 mg/kg/day. Levels of 150 and

300 mg/kg caused abortions, but were at

significant maternally toxic doses. The

developmental NOAEL was the highest

dose tested, 300 mg/kg/day. There were

no effects on embryo-fetal viability or

development at any level.

ii. Two-generation reproduction rat.

Potential effects on growth and

reproductive performance were assessed

over 2-generations of rats maintained on

diets containing technical dicamba at

concentrations of 0 control, 500, 1,500

or 5,000 ppm. Exposure at 5,000 ppm

was associated with a slower growth

rate of F1 pups prior to weaning and

resulted in lower initial body weights in

those selected as parental animals. The

lower body weight was associated with

a decrease in both food consumption

and water intake. Sexual maturation

was slightly delayed among males, but

was likely associated with the initial

reduced growth rate. Increased liver

weights were noted consistently for

adults of both generations and for

weanlings. There were no effects on

reproductive ability from treatment at

any level. The low pregnancy rate

among F, females in all groups was

considered to be due to increased

weights of those females. The NOAEL

and LOAEL for system toxicity were

1,500 and 5,000 ppm, respectively. The

NOAEL and LOAEL for reproductive

toxicity were 500 (45 mg/kg/day) and

1,500 ppm, respectively.

4. Subchronic toxicity—i. 21–Day

dermal. There were no dicamba related

changes in general behavior,

appearance, body weight, or in blood

and urine analysis. There were no

compound-related gross pathology

lesions, only skin lesions. There were

no significant organ weight variations

observed.

ii. Thirteen-week rodent feeding (rat).

Rats were offered technical dicamba at

dietary concentrations of 0, 1,000, 5,000,

or 10,000 ppm. The mean body weight

and food consumption values for the

high dietary level animals were

decreased from the control values. No

adverse treatment-related findings were

noted in either the blood parameters

investigated or necropsy evaluation.

Microscopic examinations of the liver

revealed an absence or reduction of

cytoplasmic vacuolation in the

hepatocytes of the high dietary level

animals. The no-effect level was

suggested to be 5,000 ppm.

iii. Eight-week rodent (dog). Technical

dicamba was offered orally at dietary

concentrations of 0 (Control), 100, 500,

or 2,500 ppm to dogs for 1 year.

Initially, a decrease in food

consumption was noted mainly among

males at 500 and 2,500 ppm. This was

most notable in a single 2,500 ppm male

resulting in almost no food consumed

for the first 3 weeks of feeding.

Following administration of the 2,500

ppm diet in a water slurry during weeks

4–6, this male was placed back on feed

and food consumption stabilized. There

appears to be a limit to the amount of

material that can be added to the feed

before dogs will not consume the diet.

The 2,500 ppm level was considered

close to the maximum that could be

employed, as 1 dog failed to consume

the diet when offered in the usual form.

Due mainly to the aforementioned male,

mean body weight of 2,500 ppm males

did not increase until week 5. The

overall body weight gain for the 1 year

period was comparable for all groups. It

was concluded that aside from the lower

food consumption, the no-effect level

for toxicity was 50-60 mg dicamba/kg

body weight (2,500 ppm) in both males

and females. Because of the lack of

toxicity shown in this study, the RfD

Peer Review committee concurred that

the NOEL was 2,500 ppm (HDT) and a

LOEL was not established.

Sub-chronic neurotoxicity. NOAEL

was established at 401 (m) and 472 (f)

mg/kg/day. No histopathological effects

on the peripheral or central nervous

system were noted.

5. Chronic toxicity—i.Chronic

feeding/carcinogenicity in rat. Groups of

60 rats/sex were maintained on diets

containing technical dicamba at

concentrations of either 0, 50, 250, or

2,500 ppm. An interim sacrifice of 10/

sex/level was conducted at 12 months.

Initially scheduled as a 27–month

study, males were sacrificed at 115

weeks and females at 118 weeks due to

survival rates. In males, no statistically

significant differences in data for all

tumors combined, all benign tumors

combined, and all malignant tumors

combined were obtained. A slight

increase in malignant lymphoma was

not statistically significant (pairwise

comparisons), and was not considered

to be toxicologically significant. A slight

increase in thyroid parafollicular cell

carcinoma in the high treatment group

was noted but was not statistically

significant in pairwise comparisons. In

females, no statistically significant

differences were noted in comparisons

with all tumors combined, all benign

tumors combined, and all malignant

tumors combined or in any individual

tumor type. In summary, no signs of

toxicity related to administration of

dicamba were noted. Findings among

animals in the three treatment groups

were considered to be comparable to

findings among the control animals.

Dicamba was not carcinogenic for

animals of the species, strain, and age

under the conditions of the study. Based

on the results of the study, the no effect

level was considered to be 2,500 ppm.

ii. Carcinogenicity in mice. Groups of

52 male and 52 female mice were fed

diets containing dicamba at

concentrations of 0, 50, 150, 1,000, or

3,000 ppm. Males were sacrificed

following 89 weeks of feeding and

females were sacrificed following 104

weeks of feeding. Reduced body weight

gain (not statistically different) was

noted among 3,000 ppm females.

Increased mortality noted among 3,000

ppm males was considered unlikely to

be related to treatment but could not be

completely excluded. An increased

incidence in lymphoid tumors, showing

a statistical significance at 150 and

1,000 ppm, occurred in females.

However, the incidence at 3,000 ppm

did not statistically differ from control.

Additionally, there was no significant

trend with dosage and the values for

treated females were within historical

control data. Finally, the incidence of

benign and malignant tumors in any

tissue were similar for treated and

control animals. Administration of

dicamba in the diet at achieved intakes

ranging from 5.5 to 364 mg/kg/day

Federal Register / Vol. 66, No. 246 / Friday, December 21, 2001 / Notices 65953

produced no evidence of tumorigenic

potential. Generally, no findings among

mice receiving 1,000 ppm or below were

considered to be of toxicological

significance. The dietary level of 1,000

ppm (108 mg/kg/day in males and 121

mg/kg/day in females) was defined as

the no toxic effect level. However, the

RfD committee chose to establish the

NOAEL at 3,000 ppm and stated that no

LOAEL had been established.

iii. Chronic dog. In a 1–year chronic

feeding study, dicamba 86.8% active

ingredient (a.i.) was administered to

Beagle dogs (4/sex/group) in the diet at

0, 10, 500 or 2,500 ppm (0, 2, 11, or 52

mg/kg/day) for 12 months. No adverse

effects were observed at any dose level.

No abnormalities in clinical signs,

hematology, clinical chemistry, or

urinalysis were reported. No abnormal

findings were made at necropsy, nor

were there any significant changes in

food consumption or body weight. The

NOAEL for this study is 52 mg/kg/day,

the highest dose level tested. The

LOAEL could not be established.

6. Animal metabolism. Dicamba has

been tested in rats, dogs, cattle, goats,

and hens. In all cases, dicamba is

excreted very rapidly, mainly as

unchanged dicamba and to a lesser

extent as 3,6-dichloro-2-hydroxybenzoic

acid with trace amounts of 3,6-dichloro5-hydroxy-o-anisic acid. The results of

these studies demonstrate that dicamba

is not persistent and does not

accumulate in animals.

7. Metabolite toxicology. Toxicity of

the metabolites of dicamba to humans is

concurrently evaluated during toxicity

testing because both plant, and animal

metabolites are formed during the

course of toxicity tests. Both plant, and

animal major metabolites are considered

not of toxicological concern.

8. Endocrine disruption. No specific

tests have been conducted with dicamba

to determine whether the pesticide may

have an effect in humans that is similar

to an effect produced by a naturally

occurring estrogen or other endocrine

effect. However, available data have not

implicated dicamba in such effects.

C. Aggregate Exposure

1. Dietary exposure. EPA has

established the RfD for 3,6-dichloro-oanisic acid (dicamba) at 0.045 mg/kg/

day. This RfD is based on a 2–generation

reproduction study in rat with a NOAEL

of 45 mg/kg/day and an uncertainty

factor of 1,000.

Cancer classification and risk

assessment. The cancer classification of

dicamba has been reviewed and

recommended that the compound be

classified as a Group D carcinogen, not

classifiable as to human carcinogenicity.

i. Food–chronic dietary exposure. The

estimated aggregate dietary exposure is

based on the Theoretical Maximum

Residue Contribution (TMRC)

calculation. The TMRC is a ‘‘worst case’’

estimate of dietary exposure since it is

assumed that 100% of all crops for

which tolerances are established are

treated, and that residues are at the

tolerances level. The dicamba TMRC for

the overall U.S. population from the

currently established and proposed

tolerances represents approximately

23.9% of the RfD.

ii. Drinking water. EPA does not have

monitoring data available to perform a

quantitative drinking water risk

assessment for dicamba at this time. A

Tier 1 drinking water assessment of

dicamba using the GENEEC model and

the SCI-GROW model were run to

produce estimates of dicamba

concentrations in surface and ground

water respectively. Estimated maximum

concentrations of dicamba in surface

and ground water are 98 and 0.013 ppb,

respectively. The estimated

concentrations of dicamba in surface

and ground water are less than EPA’s

level of comparison for dicamba in

drinking water as a contribution to

chronic aggregate exposure. Therefore,

taking into account present uses, and

uses proposed in this action, BASF

Corporation concludes with reasonable

certainty that residues of dicamba in

drinking water (when considered along

with other sources of exposure for

which there are reliable data), would

not result in unacceptable levels of

aggregate human health risk at this time.

iii. Acute exposure and risk. This

acute dietary (food) risk assessment

used the Dietary Exposure Evaluation

Model (DEEM). Regulating at the 95th

percentile, acute dietary exposure used

up only 28.6% of the acute RfD. The

risks from acute dietary exposures to

dicamba do not exceed EPA’s level of

concern.

iv. Chronic exposure and risk. The

chronic dietary exposure analysis from

food sources was conducted using the

RfD of 0.045 mg/kg/day. In conducting

this chronic dietary risk assessment,

EPA has made very conservative

assumptions: 100% of RACs having

dicamba tolerances will contain

dicamba residues and those residues

will be at the level of the established

tolerance. This results in an

overestimate of human dietary

exposure. The chronic DEEM analysis

used mean consumption (3–day

average) data, and showed U.S.

population (48 states) at only 23.9% of

the RfD.

2. Non-dietary exposure. Dicamba

(3,6-dichloro-o-anisic acid), is currently

registered for use on outdoor residential

and recreational turf. Application is

made by both homeowners and

professional applicators. There is a

potential oral, inhalation, eye and

dermal exposure to infants and children

to dicamba from the registered uses for

lawn and turfgrass weed control. These

exposures are considered to be very low.

Currently there are no inhalation or eye

exposure data required for postapplication of pesticides to lawns and

turf. As inhalation exposure for mixer/

loaders is acceptable, the risk to infants

and children from inhalation exposure

under a much lower exposure scenario

is characterized qualitatively as being

extremely low. Exposure data are

required for hand to mouth movements

of infants and children. As there are no

chemical-specific or site-specific data

available to determine the potential

risks associated with residential

exposures, the EPA has determined that

residential exposure and risk are

acceptable for dosages of 0.5 lb/A, based

on a dermal NOAEL of 1,000 mg/kg/day

and exposures of 0.051 mg/kg/day for

low pressure hand wand, liquid

formulations, and 0.079 mg/kg/day for

granular formulations. For residential

post-application exposure and risk

assessment, EPA determined that the

potential residential post-application

risks for short-term and intermediate

exposures did not exceed their level of

concern. In this analysis both oral and

dermal exposures, and risks for adults

and infants from post-applications were

determined. This analysis was based on

assumptions and generic data from the

Draft HED Standard Operating

Procedures (SOPs) for Residential

Exposure Assessments (December 18,

l997). These SOPs rely on what are

considered to be upper-percentile

assumptions and intended to represent

Tier 1 assessments.

D. Cumulative Effects

At this time, there is no available data

to determine whether dicamba, and its

metabolites 3,6-dichloro-5-hydroxy-oanisic acid and 3,6-dichloro-o-2-

hydroxybenzoic acid, have a common

mechanism of toxicity with other

substances or how to include this

pesticide or its metabolites in a

cumulative risk assessment. For the

purposes of this tolerance action,

therefore, BASF Corporation has not

assumed that dicamba and its

metabolites have a common mechanism

of toxicity with other substances.

E. Safety Determination

1. U.S. population. Using the

conservative exposure assumptions

described above and based on the

65954 Federal Register / Vol. 66, No. 246 / Friday, December 21, 2001 / Notices

completeness and the reliability of the

toxicity data, a risk assessment for

chronic dietary exposure from food and

feed uses was made for all subpopulations. The percentage of the RfD

occupied is only approximately 23.9%

for the general population and 71.1%

for non-nursing infants the most

exposed group.

2. Infants and children. There was

evidence of increased susceptibility to

the offspring following prenatal and/or

postnatal exposure in the 2-generation

reproduction study in rat. In this study,

offspring toxicity was manifested as

significantly decreased pup growth in

all generations and mating at a dose

lower than that which caused parental

systemic toxicity (abortions and clinical

signs of neurotoxicity). Available

studies indicated no increase

susceptibility of rats or rabbits in in

utero exposure to dicamba. In a prenatal

developmental toxicity study in rats,

there was no evidence of developmental

toxicity at the highest dose tested. In a

prenatal developmental toxicity study

in rabbits, developmental toxicity

(irregular ossification of internasal

bones), were only seen at the dose that

caused maternal toxicity (abortions and

neurotoxic clinical signs). Therefore,

there is an adequate toxicity data base

for dicamba and exposure data are

complete or are estimated based on data

that reasonably account for potential

exposures. A ten-fold safety factor for

increased susceptibility of infants and

children was applied for chronic (longterm) exposure, and a three-fold safety

factor was applied for acute (short- and

intermediate-term) exposures to

dicamba, due to evidence of increased

susceptibility to the offspring following

prenatal and/or postnatal exposure in

the 2-generation reproduction study in

rats. The uncertainty factor (FQPA

Safety Factor) of ten-fold was reduced

for acute dietary and short-term and

intermediate-term residential exposures

because the increased susceptibility was

only observed in the reproduction study

and not in the prenatal developmental

studies. The FQPA Safety Factor was

reduced to 3x for acute dietary risk

assessment for all populations,

including infants and children, because:

(1) The endpoint of concern is clinical

signs of neurotoxicity (in the absence of

neuropathology) observed following a

single oral exposure in an acute

neurotoxicity study; (2) the increased

susceptibility was seen in the offspring

of parental animals receiving repeated

oral exposures in a 2-generation

reproduction toxicity study; and (3) no

increased susceptibility was observed

following in utero exposures of rats or

rabbits in the developmental studies.

F. International Tolerances

No CODEX maximum residue levels

have been established for dicamba.

[FR Doc. 01–31494 Filed 12–20–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[OPP–30517; FRL–6810–5]

Pesticide Products; Registration

Applications

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces receipt

of applications to register pesticide

products containing new active

ingredients not included in any

previously registered products pursuant

to the provisions of section 3(c)(4) of the

Federal Insecticide, Fungicide, and

Rodenticide Act (FIFRA), as amended.

DATES: Written comments, identified by

the docket control number OPP–30517,

must be received on or before January

22, 2002.

ADDRESSES: Comments may be

submitted by mail, electronically, or in

person. Please follow the detailed

instructions for each method as

provided in Unit I. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, it is imperative

that you identify docket control number

OPP–30517 in the subject line on the

first page of your response.

FOR FURTHER INFORMATION CONTACT: Rita

Kumar, Registration Division (7505C),

Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: (703)

308–8291; e-mail address:

kumar.rita@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

Categories NAICS

codes

Examples of potentially affected entities

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

seassist 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–30517. 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 Hwy.,

Arlington, VA, from 8:30 a.m. to 4 p.m.,