63164 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Notices

c. Section 18 regulations.

2. Section 18 homepage.

3. Office of Enforcement and

Compliance Assurance (OECA) Updates:

a. Performance partnerships status.

b. Urban pesticide initiative

activities and states funding request.

c. Cooperative agreement issues.

4. Antimicrobial Issues:

a. Definition of pest in the

antimicrobial rule.

b. Clarification of state support in

the antimicrobial area.

c. Office of Enforcement and

Compliance assurance plans for efficacy

testing.

d. State lab involvement.

5. Performance Measures:

a. Results of September 1997

workshop.

b. Future activities.

c. OECA’s direction regarding

measures and GPRA.

6. Policy to address changes to worker

risk mitigation measures.

7. Quality assurance/quality control/

national environmental laboratory

program.

8. Pesticide regulatory education

program course offerings.

9. Regional reports and introduction

of issue papers.

10. Other topics as appropriate.

List of Subjects

Environmental protection.

Dated: November 20, 1997.

Jay Ellenberger,

Director, Field and External Affairs Division,

Office of Pesticide Programs.

[FR Doc. 97–31129 Filed 11–25–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[PF–777; FRL–5754–4]

Notice of Filing of Pesticide Petitions

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 the

docket control number PF–777, must be

received on or before December 26,

1997.

ADDRESSES: By mail submit written

comments to: Public Information and

Records Integrity Branch (7502C),

Information Resources and Services

Division, Office of Pesticides Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460. In

person bring comments to: Rm. 1132,

CM #2, 1921 Jefferson Davis Highway,

Arlington, VA.

Comments and data may also be

submitted electronically to: oppdocket@epamail.epa.gov. Follow the

instructions under ‘‘SUPPLEMENTARY

INFORMATION.’’ No confidential

business information should be

submitted through e-mail.

Information submitted as a comment

concerning this document may be

claimed confidential by marking any

part or all of that information as

‘‘Confidential Business Information’’

(CBI). CBI should not be submitted

through e-mail. Information marked as

CBI will not be disclosed except in

accordance with procedures set forth in

40 CFR part 2. A copy of the comment

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. All written

comments will be available for public

inspection in Rm. 1132 at the address

given above, from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays.

FOR FURTHER INFORMATION CONTACT: By

mail: Joanne Miller (PM 23),

Registration Division (7505C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., S.W.,

Washington, DC 20460. Office location,

telephone number, and e-mail address:

Rm. 237, CM #2, 1921 Jefferson Davis

Highway, Arlington, VA 22202, (703

305–6224, e-mail:

miller.joanne@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: 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 supports granting of the

petition. Additional data may be needed

before EPA rules on the petition.

The official record for this notice of

filing, as well as the public version, has

been established for this notice of filing

under docket control number [PF–777]

(including comments and data

submitted electronically as described

below). A public version of this record,

including printed, paper versions of

electronic comments, which does not

include any information claimed as CBI,

is available for inspection from 8:30

a.m. to 4 p.m., Monday through Friday,

excluding legal holidays. The official

record is located at the address in

‘‘ADDRESSES’’ at the beginning of this

document.

Electronic comments can be sent

directly to EPA at:

opp-docket@epamail.epa.gov

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Comment and data will

also be accepted on disks in

Wordperfect 5.1/6.1 or ASCII file

format. All comments and data in

electronic form must be identified by

the docket control number [PF–777] and

appropriate petition number. Electronic

comments on this notice may be filed

online at many Federal Depository

Libraries.

List of Subjects

Environmental protection,

Agricultural commodities, Food

additives, Feed additives, Pesticides and

pests, Reporting and recordkeeping

requirements.

Dated: November 4, 1997.

James Jones,

Acting Director, Registration Division, Office

of Pesticide Programs.

Summaries of Petitions

Petitioner 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.

EPA is publishing the petition

summaries verbatim without editing

them 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.

BASF Corporation

PP 6F4604, 4F3041 and FAP 4H5428

EPA has received pesticide petitions

(PP 6F4604, 4F3041, and FAP 4H5428)

from BASF Corporation, 26 Davis Drive,

Research Triangle Park, P.O. Box 13528,

NC 27709, proposing pursuant to

section 408 (d) of the Federal Food,

Drug and Cosmetic Act, 21 U.S.C.

346a(d), to amend 40 CFR 180.227 by
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Notices 63165

establishing and amending tolerances

for residues of the herbicide dicamba in

or on the raw agricultural commodities

soybeans, wheat, barley, oats, corn,

cotton, grasses and asparagus at the

proposed tolerances as described below.

The proposed analytical methods

involve extraction, partition, clean-up

and detection of residues by gas

chromatography/electron capture

detector (gc/ecd). 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 supports

granting of the petition. Additional data

may be needed before EPA rules on the

petition.

A. Residue Chemistry

1. Plant metabolism. 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 the residue—i. Plant.

Residue trials have been conducted with

dicamba on the crops for expanded use

requested in the subject petitions.

Multiple salts of dicamba were studied

in side-by-side testing to confirm that no

effect on magnitude of the residues was

caused by the salt formulation type of

the dicamba. 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-oanisic acid in or on the raw agricultural

commodities as follows 40 CFR

180.227(a): Cottonseed 3.0 parts per

million (ppm); Corn, forage 3.0 ppm;

Corn, fodder 3.0 ppm; Crop Group 17,

Grass forage, fodder and hay Forage 125

ppm, Hay 200 ppm; Wheat, forage 80

ppm, Wheat, hay 20 ppm; 21 U.S.C.

section 701 MRL Cottonseed meal 5.0

ppm; Wheat grain 2 ppm, Wheat straw

30 ppm; Barley grain 2 ppm; Barley

straw 30 ppm.

Proposed tolerances for combined

residues of the herbicide dicamba (3,6-

dichloro-o-anisic acid) and its

metabolite 3,6-dichloro-2-

hydroxybenzoic acid in or on the raw

agricultural commodities as follows 40

CFR 180.227(b): Soybean grain 4 ppm,

Soybean hulls 13 ppm; Asparagus 3.5

ppm.

Only newly generated data, or data

not implicated in the CRAVEN

Laboratories indictment are used to

support the subject petitions.

Dicamba residues concentrate in the

following commodities: soybean hulls;

sugarcane molasses; cottonseed meal.

ii. Animal. The amended 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

Data are provided that are

representative of the mammalian

toxicity effects of dicamba and are part

of the many studies conducted to

support the BASF Corp. assertion of

safety of dicamba to humans.

1. Acute toxicity—i. Oral Rat LD50:

1,879 mg/kg (m); 1581 mg/kg (f).

ii. Acute Dermal Rat LD50: > 2,000 kg/

kg (m/f).

iii. Acute Inhalation Rat LC50: > 9.6

mg/L (m/f).

iv. Primary Eye Irritation: Extremely

irritating and corrosive to the eye.

v. Primary Dermal Irritation Rabbits:

Not a primary skin irritant.

vi. Dermal Sensitization Guinea Pigs:

Moderate potential to cause dermal

sensitization.

vii. Acute Neurotoxicity: NOEL <300

mg/kg (lowest dose tested).

Neurobehavioral effects were observed

at all dose levels but primarily at the

initial 1.5 hr post-dose testing only. No

neurobehavioral effects were noted by

day 14 after treatment and no

neuropathological effects were found

indicating there are no persistent effects

on the nervous system.

2. Genotoxicity. Ames: Negative; In

vitro chromosome aberration in Chinese

Hamster Ovary: Negative; Sex-linked

recessive lethal in Drosophila: Negative;

Chromosome aberrations in rat bone

marrow: Negative; Mitotic

recombination: Negative; UDH (UDS

with WI-38 human lung fibroblasts:

Negative; DNA damage as detected with

repair deficient prokaryote E. coli:

Positive; DNA damage as determined

with repair deficient eukaryote S.

typhimurium: Negative; UDS in human

lung lymphocytes with activation:

Negative; Sister chromatid exchange in

human cultured lymphocytes: slight

increase. Overall weight of the evidence

from all studies indicates that dicamba

is not genotoxic.

3. Reproductive and developmental

toxicity—i. Rodent developmental

toxicity rat. Oral doses of 0, 64, 160, or

400 mg/kg were administered daily

during gestation days 6 to 19. Maternal

toxicity occurred at the high dose as

evidenced by mortality of four animals,

clinical signs and decreased weight

gain. The numbers of implantations,

resorptions, and fetuses for test animals

were similar to those numbers for

control animals. No fetal abnormalities

were attributed to exposure to dicamba.

Therefore, technical dicamba was not

found to be teratogenic. Maternal

toxicity was found only at the HDT with

a NOEL of 160 mg/kg/day. The

developmental NOEL was the highest

dose tested of 400 mg/kg/day.

ii. Rabbit developmental toxicity.

Dicamba was administered orally

(undiluted) via capsule to groups of 20

artificially inseminated New Zealand

White rabbits at dose levels of 0, 30,

150, or, 300 mg/kg on days 6-18 of

presumed-gestation. Females were

sacrificed on Day 29 of presumed

gestation. Maternal toxicity occurred at

150 and 300 mg/kg/day as evidenced by

clinical signs and either body weight

loss or reduced weight gain. Abortions

occurred at 150 and 300 mg/kg/day. No

significant differences were obtained in

litter averages for corpora 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. Therefore,

dicamba was found to be not

teratogenic. The maternal no-observedadverse-effect-level (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.

iii. 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,
63166 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Notices

or 5,000 ppm. Parental toxicity occurred

at 5,000 ppm in the form of lower

weight gain in females and increased

liver weights of both sexes. 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. F2 pup

weights were reduced at 3,000 and

1,500 ppm. There were no treatmentrelated effects on reproductive ability at

any level. The NOEL and LOEL for

systemic toxicity were 1,500 (approx.

130 mg/kg/day) and 5,000 ppm,

respectively. The NOEL and LOEL for

pup toxicity were 500 (approx. 45 mg/

kg/day) and 1,500 ppm, respectively.

4. Subchronic toxicity—i. Twentyone-day Dermal. Technical dicamba was

applied dermally to rabbits for 5 days a

week for three weeks at dosage levels of

0, 100, 500 and 2,500 mg/kg/day. There

were no systemic effects at any level of

treatment. Skin irritation was evident at

all treatment levels, but consisted of

only a slight erythema at 100 mg/kg/

day. The systemic NOEL was the

highest dose tested of 2,500 mg/kg/day.

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 NOEL was 5,000 ppm (342

mg/kg/day males, 392 mg/kg/day

females).

iii. Thirty-eight-week non-rodent

(dog). In a dose-range finding study for

a subsequent chronic dog study, a small

number of dogs were treated via the feed

with technical dicamba at dosage levels

of 0, 1,000, 2,500 and 5,000 ppm for

four to eight weeks. Decreased food

consumption occurred in all dose

groups during the first week of

treatment, and persisted in some dogs at

2,500 and 5,000 ppm. Decreased body

weight gains or weight loss were noted

in the treatment groups. The NOEL from

the one-year dog study discussed below

is used to satisfy the requirement for the

subchronic dog NOEL.

iv. Sub-chronic neurotoxicity. Rats

were fed technical dicamba for 13 weeks

at dosage levels of 0, 3,000, 6,000 and

12,000 ppm. Body weights were slightly

reduced in high dose animals.

Neurobehavioral effects were noted at

the high dose and consisted primarily of

signs associated with rigidity in

response to handing. No

histopathological effects on the

peripheral or central nervous system

were noted. The neurotoxicity NOEL

was established at 6,000 ppm (401 mg/

kg/day males, and 472 mg/kg/day,

females).

5. Chronic toxicity—i. Chronic

toxicity-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 1st 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, there were no effects

due to treatment with dicamba. The noeffect level for toxicity was the highest

dose tested of 2,500 ppm (approx. 59

mg/kg/day males, 57 mg/kg/day

females).

ii. Chronic feeding/oncogenicity 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 (108 week)

study, males were sacrificed at 115

weeks and females at 118 weeks due to

high survival rates.

There were no effects due to treatment

on any chronic toxicity parameters

investigated. 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. Dicamba was not

oncogenic. Based on the results of the

study, the no effect level was considered

to be 2,500 ppm (107 mg/kg/day males

and 127 mg/kg/day females).

iii. Oncogenicity in mice. Groups of

mice were fed diets containing dicamba

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

3,000 ppm. Males were killed following

89 weeks of feeding and females were

killed 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. The incidence of benign

and malignant tumors in all tissues were

similar for treated and control animals.

The NOEL was determined to be 1,000

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

mg/kg/day in females). However, the

RfD best committee chose to establish

the NOEL at 3,000 ppm and stated that

no LOEL had been established.

6. Estrogenic or other endocrine

effects. No specific tests have been

conducted to determine endocrinedisrupting effects. However, extensive

subchronic and chronic tests have been

conducted in several species, and

results have demonstrated no effects on

the endocrine system.

7. 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.

8. Metabolite toxicity. Toxicity of the

metabolites of dicamba to humans is

concurrently evaluated during toxicity

testing because both plant and animal
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Notices 63167

metabolites are formed during the

course of toxicity tests. Both plant and

animal major metabolites are considered

not of toxicological concern.

C. Aggregate Exposure

1. Dietary exposure. Exposure from

the use of Dicamba in the culture of

wheat, barley, oats, millet, sorghum,

corn, soybeans, grasses, cotton,

sugarcane and asparagus crops is

discussed under the below topics of

food and drinking water.

2. Food. The subject petition amends

these uses but does not add new crops.

The potential dietary exposure of the

population to residues of dicamba or its

metabolites is calculated based on the

Theoretical Maximum Residue

Contribution (TMRC) for all crops with

dicamba use. The TMRC is a worst case

estimate of dietary exposure since it

assumes that 100 percent of all crops for

which tolerances are established are

treated with dicamba, and that pesticide

residues are present at the tolerance

levels. The resulting dietary exposure

estimate therefore overestimates

exposure and is considered

conservative. The number is then

determined to be a percentage of the

EPA decided Reference Dose (RfD).

Dietary exposure may occur from crop

commodities and meat and milk. Based

on the EPA DRES model BASF Corp.

has estimated that the average US

population dietary exposure to dicamba

to be only 1.87% percent of the RfD.

This number is very low and considered

very safe as an active ingredient is

allowed up to 100% before less

conservative risk assessment measures

are initiated.

Acute dietary analysis compared the

daily dietary exposure to the lowest

NOEL for acute and subchronic studies.

EPA’s current policy for Tier I analysis

uses the conservative assumption that

all residues are at a high end estimate

or maximum, typically taken as the

tolerance value. Acute dietary

assessment for dicamba is made by

comparing the ratio of exposure and the

NOEL from acute neurotoxicity of 300

mg/kg/day to achieve a Margin of

Exposure (MOE). A MOE of 300 is

required because a NOEL was not

reached in the acute neurotoxicity test.

The following MOE values are obtained

for key population subgroups.

Population Subgroup Margin of Exposure

US Population 6000

Infants <1 year 3000

Population Subgroup Margin of Exposure

Children 1 to 6 3000

Females 13+ years 17000

Males 13+ years 10000

3. Drinking water. Dicamba has been

used commercially for in excess of 30

years. From available public data,

detections in ground water from

commercial uses have been very low

and infrequent. The typical level found

in ground water is less than 5 ppb. This

should be compared to the current

Health Advisory Level (HAL) of 200 ppb

and the anticipated HAL of 3,000 ppb

under the newly revised RfD of 0.45 mg/

kg/d.

These infrequent and low levels of

detection in groundwater demonstrate

that significant movement of dicamba is

not likely and is not a considerable

factor in assessing human health risk.

4. Non-dietary exposure. Non-dietary

exposure would mainly occur from the

use of dicamba for broadleaf weed

control on residential or recreational

turf. BASF is currently collecting data

on the potential exposure from nondietary sources such as residential turf

use. However, no reliable information is

currently available for risk assessment at

this time. This petition is only related

to already approved crop uses and

therefore non-dietary route of exposure

is not considered to be a factor in

assessing additional human risk.

D. Cumulative Effects

Dicamba belongs to the benzoic acid

class of compounds. There are no other

compounds of this class in significant

use and none in food use. Therefore,

cumulative effects from dietary or nonoccupational exposure from pesticides

of similar chemistry are considered

unlikely. BASF Corp. does not have

reliable data to indicate a common

mechanism of toxicity to other

compounds. Therefore cumulative

effects from common mechanisms of

action are also unlikely.

E. Safety Determination

The RfD for dicamba is 0.45 mg/kg/d.

The RfD is a level at or below which

daily aggregate exposure over a lifetime

will not cause appreciable human

health risk. The estimates of exposure

are based on conservative assumptions

that all crops with a tolerance for

dicamba are treated and that all residues

found are at the maximum or tolerance

level.

1. U.S. population. Using the

conservative assumptions described

above, BASF Corp. has estimated that

the US population dietary exposure to

dicamba is 1.87% percent of the RfD.

2. Infants and children. Dicamba was

not teratogenic in either rats or rabbits

despite testing to maternally toxic

doses. No developmental toxicity was

observed in rats and the only effect

observed in rabbits were abortions at

clearly maternally toxic doses. Dicamba

produced no effects on reproduction in

a 2-generation study in rats. The only

effect observed was a decrease in pup

body weight at the high dose which also

produced parental toxicity, and at the

mid-dose that was relatively high (130

mg/kg/day). Based on the weight of

evidence from all reproductive and

developmental studies, no selective

toxic efects on infants and children are

expected, and no additional safety factor

is warranted.

Using the conservative assumptions

described above, BASF Corp. has

estimated the dietary exposure to

infants and children as percent of the

RfD. From the current and new

proposed use of dicamba dietary

exposure for the most sensitive

subgroups are 6.65% for non-nursing

infants (<1 yr old) and 4.6% for children

1 to 6 yrs old.

Aggregate exposure due to the

combined residues in food, drinking

water and non-dietary exposure through

direct contact with residues in a

residential setting (lawn) should be

pursued through the use of a reserve

risk approach. The elements for

consideration are therefore estimated as

follows:

Food: Total Population . . . . . .1.87%

Non-nursing Infants <6 yrs . . . 6.7%

Water/Lawn: Low human risk. . . . . .

expected to be inconsequential

BASF Corp. believes that the water

and non-dietary exposure risk for the

most sensitive subgroup is

inconsequential due to demonstrated

low findings in water relative to the

HAL and low toxicity to humans with

respect to oral, dermal and inhalation

exposure.

Aggregate exposure is therefore

estimated to be less than 10% of the RfD

for the most sensitive population

subgroup. Therefore, BASF Corp.

concludes that there is reasonable

certainty that no harm will result from

aggregate exposure of residues of

dicamba or its metabolites including all

dietary and other non-occupational

exposures.
63168 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Notices

F. International Tolerances

No international tolerances have been

established under CODEX. Therefore

there is no need to ensure consistency.

[FR Doc. 97–30813 Filed 11–25–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[PF–776; FRL–5753–3]

Notice of Filing of Pesticide Petitions

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 the

docket control number PF–776, must be

received on or before December 26,

1997.

ADDRESSES: By mail submit written

comments to: Public Information and

Records Integrity Branch (7502C),

Information Resources and Services

Division, Office of Pesticides Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460. In

person bring comments to: Rm. 1132,

CM #2, 1921 Jefferson Davis Highway,

Arlington, VA.

Comments and data may also be

submitted electronically to: oppdocket@epamail.epa.gov. Follow the

instructions under ‘‘SUPPLEMENTARY

INFORMATION.’’ No confidential

business information should be

submitted through e-mail.

Information submitted as a comment

concerning this document may be

claimed confidential by marking any

part or all of that information as

‘‘Confidential Business Information’’

(CBI). CBI should not be submitted

through e-mail. Information marked as

CBI will not be disclosed except in

accordance with procedures set forth in

40 CFR part 2. A copy of the comment

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. All written

comments will be available for public

inspection in Rm. 1132 at the address

given above, from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays.

FOR FURTHER INFORMATION CONTACT: The

Regulatory Action Leader listed in the

table below:

Regulatory Action

Leader Telephone Number/E-mail Address Office Location/Address

Driss Benmhend .... 703–308–9525, e-mail: benmhend.driss@epamail.epa.gov. 5th floor CS#1, 2800 Crystal Drive, Arlington, VA 22202

Michael

Mendelsohn.

703–308–8715, e-mail: mendelsohn.mike@epamail.epa.gov. Do.

SUPPLEMENTARY INFORMATION: 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 supports granting of the

petition. Additional data may be needed

before EPA rules on the petition.

The official record for this notice of

filing, as well as the public version, has

been established for this notice of filing

under docket control number [PF–776]

(including comments and data

submitted electronically as described

below). A public version of this record,

including printed, paper versions of

electronic comments, which does not

include any information claimed as CBI,

is available for inspection from 8:30

a.m. to 4 p.m., Monday through Friday,

excluding legal holidays. The official

record is located at the address in

‘‘ADDRESSES’’ at the beginning of this

document.

Electronic comments can be sent

directly to EPA at:

opp-docket@epamail.epa.gov

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Comment and data will

also be accepted on disks in

Wordperfect 5.1/6.1 or ASCII file

format. All comments and data in

electronic form must be identified by

the docket control number [PF–776] and

appropriate petition number. Electronic

comments on this notice may be filed

online at many Federal Depository

Libraries.

List of Subjects

Environmental protection,

Agricultural commodities, Food

additives, Feed additives, Pesticides and

pests, Reporting and recordkeeping

requirements.

Dated: November 18, 1997.

Janet Andersen,

Director, Biopesticides and Pollution

Prevention Division, Office of Pesticide

Programs.

Summaries of Petitions

Petitioner 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.

EPA is publishing the petition

summaries verbatim without editing

them 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.

1. Engelhard Corporation

PP 7E4908

EPA has received a pesticide petition

(PP 7E4908) from Engelhard

Corporation, 101 Wood Avenue, Iselin,

NJ 08830, proposing pursuant to section

408(d) of the Federal Food, Drug and

Cosmetic Act, 21 U.S.C. 346a, to amend

40 CFR part 180 by establishing an

exemption from the requirement of a

tolerance for residues of kaolin in or on

all food commodities. Pursuant to the

section 408(d)(2)(A)(i) of the FFDCA, as

amended, Engelhard Corporation has

submitted the following summary of

information, data, and arguments in

support of their pesticide petition.

A. Proposed Use Practices

Kaolin is to be used as an aid in

control of damage to plants from insects,

mites, fungi, and bacteria. Kaolin is

used at the rates of 6.25 to 12.4 lbs/acre

for row crop vegetables, 25 to 175 lbs/

acre for tree fruit crops, and 12.5 to 37.5

lbs/acre for small fruit crops. Treatment

is made prior to leaf or plant emergence

and applied to crops at 7 to 10 day