Federal Register / Vol. 62, No. 48 / Wednesday, March 12, 1997 / Notices 11437

would be significantly lower if

anticipated residues were utilized rather

than tolerance values. Therefore,

AgrEvo concludes that there is a

reasonable certainty that no harm will

result to infants or children from

aggregate exposure to propamocarb

residues.

I. International Tolerances

The Codex Alimentarius Commission

(Codex) has established tolerances

(MRLs) for propamocarb in the

following raw agricultural commodities:

Commodity Part per million

Beetroot 0.2 ppm

Brussels sprouts 1.0 ppm

Cabbage, head 0.1 ppm

Celery 0.2 ppm

Cucumber 2.0 ppm

Cauliflower 0.2 ppm

Lettuce, head 10.0 ppm

Pepper, sweet 1.0 ppm

Radish 5.0 ppm

Strawberry 0.1 ppm

Tomato 1.0 ppm

The FAO/WHO/JMPR have

recommended an Acceptable Daily

Intake (ADI) of 0.1 mg/kg/day.

J. Conclusions

AgrEvo USA believes that the

proposed use of propamacarb on

potatoes would not pose a significant

risk to human health, including that of

infants and children, and is in

compliance with the requirements of the

Food Quality Protection Act of 1996.

Moreover, the proposed tolerances for

propamocarb in potato commodities,

meat and milk, of 0.05 ppm, should be

established.

II. Public Record

Interested persons are invited to

submit comments on this notice of

filing. Comments must bear a notation

indicating the docket control number,

[PF–716]. All written comments filed in

response to this petition will be

available in the Public Response and

Program Resources Branch, at the

address given above from 8:30 a.m. to 4

p.m., Monday through Friday, except

legal holidays.

A record has been established for this

notice under docket control number

[PF–716] 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 public

record is located in Rm. 1132 of the

Public Response and Program Resources

Branch, Field Operations Division

(7506C), Office of Pesticide Programs,

Environmental Protection Agency,

Crystal Mall #2, 1921 Jefferson Davis

Highway, Arlington, VA.

Electronic comments can be sent

directly to EPA at:

opp-docket@epamail.epa.gov

Electronic comments must be

submitted as ASCII file avoiding the use

of special characters and any form of

encryption.

The official record for this notice, as

well as the public version, as described

above will be kept in paper form.

Accordingly, EPA will transfer all

comments received electronically into

printed, paper form as they are received

and will place the paper copies in the

official record which will also include

all comments submitted directly in

writing. The official record is the paper

record maintained at the address in

‘‘ADDRESSES’’ at the beginning of this

document.

Authority: 21 U.S.C. 346a.

List of Subjects

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping.

Dated: February 26, 1997.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

[FR Doc. 97–5681 Filed 3–11–97; 8:45 am]

BILLING CODE 6560–50–F

[PF–712; FRL–5587–7]

The Cryolite Task Force; Pesticide

Tolerance Petition Filing

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of filing.

SUMMARY: This notice announces the

filing of a pesticide petition proposing

regulations establishing tolerances for

residues of the insecticidal fluorine

compounds cryolite and/or synthetic

cryolite (sodium aluminum fluoride or

sodium aluminofluoride) in or on

potatoes and in processed potato waste.

This notice includes a summary of the

petition that was prepared by the

petitioner, The Cryolite Task Force.

DATES: Comments, identified by the

docket control number [PF-712] must be

received on or before April 11, 1997.

ADDRESSES: By mail, submit written

comments to: Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide 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

22202.

Comments and data may also be

submitted electronically by sending

electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Electronic

comments must be submitted either in

ASCII format (avoiding the use of

special characters and any form of

encryption) or in WordPerfect in 5.1 file

format. All comments and data in

electronic form must be identified by

the docket control number [PF-712].

Electronic comments on this notice may

be filed online at many Federal

Depository Libraries. The official record

for this rulemaking, as well as the

public version described above, will be

kept in paper form. Additional

information on electronic submissions

can be found in Unit II. of this

document.

Information submitted as a comment

concerning this notice may be claimed

confidential by marking any part or all

of that information as ‘‘Confidential

Business Information’’ (CBI).

Information so marked will not be
11438 Federal Register / Vol. 62, No. 48 / Wednesday, March 12, 1997 / Notices

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

No CBI should be submitted through email. 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.

FOR FURTHER INFORMATION CONTACT:

William Jacobs, Acting, Product

Manager 14, Registration Division,

Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location, telephone number, and

e-mail address: Rm. 219, CM #2, 1921

Jefferson Davis Highway, Arlington, VA

22202. (703) 305-6600; e-mail:

jacobs.william@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA has

received a pesticide petition from The

Cryolite Task Force c/o Gowan, P.O.

Box 5568, Yuma, AZ 85366. The

petition proposes, pursuant to section

408 of the Federal Food, Drug, and

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

to amend 40 CFR 180.145 to renew the

regulations that established tolerances

for the insecticidal fluorine compounds

cryolite and/or synthetic cryolite in or

on potatoes at 2.0 parts per million

(ppm) and processed potato waste at 22

ppm.

EPA has determined that the 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 supports granting of the

petition. Additional data may be needed

before EPA rules on the petition.

As required by section 408(d) of the

FFDCA, as recently amended by the

Food Quality Protection Act (FQPA)

(Pub. L. 104-170), The Cryolite Task

Force included in the petition a

summary of the petition and

authorization for the summary to be

published in the Federal Register in a

notice of receipt of the petition. The

summary represents the views of The

Cryolite Task Force; EPA is in the

process of evaluating the petition. As

required by section 408(d)(3), EPA is

including the summary as a part of this

notice of filing. EPA may have made

minor edits to the summary for

purposes of clarity.

I. The Cryolite Task Force’s Petition

Summary

This petition is submitted by the

Cryolite Task Force (Consortium No.

62569), under section 408 of the

FFDCA, as most recently amended by

the FQPA.

This submission amends petitions PP

9F3739 and FAP 1H5604 by providing

the additional information specified by

the FQPA. A permanent tolerance is

proposed for residues of the insecticide

sodium aluminofluoride (cryolite and/or

synthetic cryolite) in or on the raw

agricultural commodities (RAC)

potatoes, as provided by the new

FFDCA section 408. In addition, the

petitioner proposes that EPA establish a

permanent tolerance for residues of

cryolite in processed potato waste, as

provided under the new FFDCA section

408.

Time-limited tolerances for residues

of sodium aluminofluoride (cryolite

and/or synthetic cryolite) in/on potatoes

and processed potato waste were

initially granted on May 5, 1993. These

tolerances expired on May 6, 1996. A

time limitation was required initially for

these regulations because a chronic dog

feeding study and a two-generation rat

reproduction study were outstanding.

These two studies were submitted and

were found acceptable in reviews dated

April 13, 1994 (chronic dog) and

February 24, 1995 (rat reproduction). In

the Federal Register of May 8, 1996 (61

FR 20781) (FRL–5362–6), EPA proposed

establishing permanent tolerances of 2

ppm and 22 ppm for residues of cryolite

in/on potatoes and processed potato

waste, respectively. A 30–day comment

period was specified by the Agency for

these proposed regulations. However,

prior to publication of final regulations,

the FQPA specified additional

requirements for tolerance petitions.

This submission amends PP 9F3739 and

FAP 1H5604 by providing the

additional information specified.

A. Residue Data

1. Name, identity, and composition of

the residue. Cryolite (sodium

aluminofluoride, sodium

hexafluoroaluminate or sodium

aluminum fluoride) is a fluorinecontaining insecticide which is found in

naturally occurring mineral deposits

and also is produced synthetically.

Empirical Formula: Na3AlF6

Molecular Weight: 209.97

CAS Registry No.: 15096-52-3

OPP Chemical Code: 075101

A Reregistration Eligibility Decision

(RED) was issued for cryolite in August

1996. As documented in the May 8,

1996 Federal Register and reiterated in

the RED, the Agency has determined

that plant residues are inorganic surface

residues of cryolite, measured as total

fluoride; and that the residue of concern

in animals also is total fluoride.

Provisions in the FQPA which are

relevant to degradates or metabolites of

pesticide chemical residues are not

applicable to elemental fluorine.

2. Magnitude of the residue in plants.

As documented in the May 8, 1996

Federal Register and reiterated in the

RED, the Agency has concluded that

complete and acceptable crop residue

data are available to support the

proposed tolerance of 2 ppm in or on

potatoes.

Data previously reviewed by EPA

show background levels of fluoride in

untreated potatoes ranging from 0.14

ppm to 0.31 ppm. Levels of fluoride

found in treated potatoes ranged from

0.18 ppm to 0.94 ppm.

3. Magnitude of the residue in

processed food/feed. As documented in

the May 8, 1996 Federal Register and

reiterated in the RED, EPA has

concluded that an acceptable potato

processing study supports the proposed

tolerance of 22 ppm in or on processed

potato waste. This study indicates that

cryolite residues concentrated 11x in

potato peels/potato waste processed

from potatoes treated at a 6.7x

exaggerated rate. Residues did not

concentrate in potato chips, flakes, or

granules.

4. Directions for use. Labeling has

been approved for foliar application to

potatoes at up to 11.5 lbs. active

ingredient (a.i.) per acre, with a

maximum seasonal application of 92

lbs. a.i. per acre.

5. Analytical method. EPA concluded

in the May 8, 1996 Federal Register and

reiterated in the cryolite RED that

adequate methodology is available for

data collection and tolerance

enforcement. Methods for both plant

residues and animal tissues have

undergone successful Agency validation

and will be published in PAM, Vol. II.

Using these methods, total fluoride is

determined using a pH/ion meter with

a fluoride-specific electrode. The limit

of quantitation is 0.05 ppm. The residue

analytical method does not distinguish

between naturally occurring fluoride

and fluoride resulting from agricultural

use of cryolite. Current FDA multiresidue screening protocols are not

appropriate for inorganic fluoride

residues.

6. Practical methods for removing

residues. Plant residues are inorganic

surface residues of cryolite. Data

previously submitted in FAP 1H5604

show that washing and peeling are

effective methods of removing these

residues.

7. Plant metabolism. EPA concluded

in the May 8, 1996 Federal Register and

reiterated in the cryolite RED that the

qualitative nature of the residue in

plants is understood and that plant

residues are inorganic surface residues
Federal Register / Vol. 62, No. 48 / Wednesday, March 12, 1997 / Notices 11439

of cryolite which are measured as

fluoride.

8. Animal metabolism. EPA

concluded in the May 8, 1996 Federal

Register and reiterated in the cryolite

RED that cryolite metabolism in animals

manifests itself as free fluoride, that the

qualitative nature of the residue is

understood and that total fluoride is the

residue of concern.

9. Magnitude of the residue in meat,

milk, poultry and eggs. EPA concluded

in the May 8, 1996 Federal Register and

reiterated in the cryolite RED that there

is no reasonable expectation of finite

fluoride residues in ruminant or poultry

tissues as a result of livestock ingestion

of cryolite.

B. Toxicological Data

The cryolite RED concluded that the

toxicological data base was adequate for

a reregistration eligibility decision for

numerous crop uses, including potatoes.

No additional toxicology requirements

were specified in the RED. The cryolite

residue of toxicological concern is

fluoride; and health effects identified for

fluoride in humans and animals are

skeletal and dental fluorosis. Dental

fluorosis (mottling of tooth enamel) is

not considered to be an adverse effect.

Further, the Agency has determined

that although fluoride accumulation is

demonstrated in a number of studies,

the accumulation itself is not

considered an adverse effect.

1. Acute toxicity. A rat acute oral

toxicity study (MRID 00138096) showed

an LD50 greater than 5,000 milligrams/

kilograms (mg/kg). A rabbit acute

dermal toxicity study (MRID 00128107)

demonstrated an LD50 of 2,100 mg/kg.

An LC50 > 2.06 mg/L and < 5.03 mg/L

was seen in an acute inhalation study

with rats (MRID 00128107). Technical

cryolite is a moderate eye irritant in

rabbits (MRID 00128106). Cryolite is not

a skin irritant to rabbits (MRID

00128106) and is not a dermal sensitizer

to guinea pigs (MRID 00138097).

2. Subchronic toxicity. Cryolite was

tested in a 28-day range-finding feeding

study in rats (MRID 00128109) at dose

levels of 0, 250, 500, 1,000, 2,000, 4,000,

10,000, 25,000, and 50,000 ppm in the

diet (representing approximately 0, 25,

50, 100, 200, 400, 1,000, 2,500 and 5,000

mg/kg/day). The only compound related

effect seen in this study was a change

in coloration and physical property of

the teeth. A no observed effect level

(NOEL) was not determined in this

study. The lowest observed effect level

(LOEL) is 250 ppm (25 mg/kg/day)

based on dental fluorosis.

In a 90–day rat feeding study (MRID

00158000), cryolite was tested at dose

levels of 0, 50, 5,000, and 50,000 ppm

(corresponding to 0, 3.8, 399.2, and

4,172.3 mg/kg/day in males and 0, 4.5,

455.9, and 4,758.1 mg/kg/day in

females). The NOEL was 50 ppm (3.8

mg/kg/day) for effects other than

fluoride accumulation. The LOEL was

5,000 ppm (399.2 mg/kg/day) based on

lesions observed in the stomach.

Fluoride accumulated at all dose levels

in this study. Cryolite was tested in a

90–day dog feeding study (MRID

00157999) at dose levels of 0, 500,

10,000, and 50,000 ppm (corresponding

to 0, 17,368, and 1,692 mg/kg/day). The

NOEL was 10,000 ppm (368 mg/kg/day).

The LOEL was 50,000 ppm (1,692 mg/

kg/day) for effects other than fluoride

accumulation. Fluoride accumulation

occurred at all dose levels.

A 21–day subchronic dermal toxicity

study in rabbits (MRID 41224801) is

considered invalid because it is likely

that cryolite was ingested by the test

animals during the study. For this

reason, the systemic dermal NOEL and

LOEL could not be determined from this

study. EPA noted in the RED that an

additional subchronic dermal study is

not necessary, because based on its

chemical/physical properties, cryolite

would not be absorbed through the skin

to any appreciable extent.

3. Genotoxicity. Cryolite was negative

in an Ames reverse mutation test (MRID

41838401) using Salmonella

typhimurium with and without

activation at dose levels of 167, 500,

1,670, 5,000, 7,500, and 10,000 μg/plate.

Cryolite was tested in an in vitro

chromosome aberration assay (MRID

41838402) using human lymphocytes at

100, 500, and 1,000 μg/ml, with and

without activation. The results were

negative. Cryolite also was negative in

an unscheduled DNA synthesis study

(MRID 41838403) with rat hepatocytes

at dose levels up to and including 50 μg/

ml.

4. Chronic toxicity. The Agency

concluded in the May 8, 1996 Federal

Register and reiterated in the cryolite

RED that the available information does

not support the regulation of cryolite

insecticides as carcinogens. The Agency

has classified cryolite as a Group D

chemical (not classifiable as to human

carcinogenicity. Further, EPA has noted

that fluoride has been the subject of a

comprehensive review by the National

Research Council (National Academy of

Sciences Subcommittee of Health

Effects of Ingested Fluoride) who

concluded that ‘‘. . .the available

laboratory data are insufficient to

demonstrate a carcinogenic effect of

fluoride in animals’’ and that ‘‘. . .the

weight of evidence from more that 50

epidemiological studies does not

support the hypothesis of an association

between fluoride exposure and

increased cancer risk in humans.’’ As

stated in the May 8, 1996 Federal

Register and reiterated in the cryolite

RED, the Agency is in agreement with

the conclusions reached by the National

Academy of Science (NAS).

The following specific chronic/

oncogenicity studies are included in the

cryolite toxicology data base:

A 2–year bioassay in B6C3F1 mice

(HED DOC No. 009682) was conducted

by the National Toxicology Program

(NTP) using sodium fluoride as the test

material at dose levels of 0, 25, 100, and

175 ppm, in water, representing 0, 2.4,

9.6, and 16.7 mg/kg/day in males and 0,

2.8, 11.3, and 18.8 mg/kg/day in

females. The NOEL was less than 25

ppm (2.4 mg/kg/day). The LOEL was 25

ppm (2.4 mg/kg/day) based on attrition

of the teeth in males, discoloration and

mottling of the teeth in males and

females, and increased bone fluoride in

both sexes. NTP considered that there

was no evidence of carcinogenic activity

in male and female mice.

A 2–year bioassay in F344/N rats

(HED DOC No. 009682) also was

conducted by the NTP using sodium

fluoride as the test material at dose

levels of 0, 25, 47, 100, and 175 ppm,

in water, representing 0, 1.3, 5.2, and

8.6 mg/kg/day in males and 0, 1.3, 5.5,

and 9.5 mg/kg/day in females.

Osteosarcoma of the bone was observed

only in 1 male of 50 (1/50) in the 100

ppm group and in 3 of 80 (3/80) males

in the 175 ppm group. The NOEL was

less than 25 ppm (1.3 mg/kg/day). The

LOEL was 25 ppm (1.3 mg/kg/day)

based on mottling of teeth, dentine

incisor dysplasia, increased serum,

urine and bone fluoride levels in males

and females and incisor odontoblast and

incisor ameloblast degeneration in

males. NTP considered that there was

‘‘equivocal evidence’’ of carcinogenic

activity in male rats in this study and

‘‘no evidence’’ of carcinogenic activity

in female rats.

EPA concluded in the May 8, 1996

Federal Register and reiterated in the

cryolite RED that the NTP studies

utilizing sodium fluoride in lieu of

cryolite satisfy the guideline study

requirements for both the rodent

chronic feeding study and the rat

carcinogenicity study. Fluoride has been

identified as the residue of toxicological

concern in cryolite and synthetic

cryolite and these compounds act as free

fluoride. It should be noted that the NTP

studies, which utilized freely soluble

NaF represent a worst-case toxicological

scenario on a ppm basis compared to

what would be expected with cryolite

per se, from which fluoride ion

dissociation is much more limited.
11440 Federal Register / Vol. 62, No. 48 / Wednesday, March 12, 1997 / Notices

A 1-year chronic dog feeding study

(MRID 42575101) was conducted with

cryolite at dose levels of 0, 3,000,

10,000, and 30,000 ppm, representing 0,

95, 366, and 1,137 mg/kg/day in males

and 0, 105, 387, and 1,139 mg/kg/day in

females (in terms of fluoride, the doses

are 0, 51, 198, and 614 mg F/kg/day for

males and 0, 57, 209, and 615 mg F/kg/

day for females). The NOEL was less

than 3,000 ppm (95 mg/kg/day in males

and 105 mg/kg/day in females). The

LOEL was 3,000 ppm based on increases

in emesis, nucleated cells in males,

renal lesions, and a decrease in urinespecific gravity in females.

5. Reproductive toxicity. A twogeneration rat reproduction study

(MRID 43387501) was conducted with

cryolite at dietary dose levels of 0, 200,

600, and 1,800 ppm (representing 0, 14,

42, and 128 mg/kg/day for males and 0,

16, 49, and 149 mg/kg/day for females,

respectively, during premating). The

systemic toxicity NOEL was not

determined. The LOEL for systemic

toxicity was 200 ppm (15 mg/kg/day)

based on dental fluorosis. The NOEL

and LOEL for reproductive toxicity were

600 and 1,800 ppm, respectively (46 and

138 mg/kg/day) based on decreased pup

body weights.

The National Research Council (NRC)

has reviewed the potential for

reproductive effects from fluoride per

se. In the report Health Effects of

Ingested Fluoride, the NRC concluded

that:

There have been reports of adverse effects

on reproductive outcomes associated with

high levels of fluoride in many animal

species. In most of the studies, however, the

fluoride concentrations associated with

adverse effects were far higher than those

encountered in drinking water. The apparent

threshold concentration for inducing

reproductive effects was 100 mg/L in mice,

rats, foxes and cattle; 100-200 mg/L in minks,

owls and kestrels; and over 500 mg/L in

hens. Based on these findings, the

subcommittee concludes that the fluoride

concentrations associated with adverse

reproductive effects in animals are far higher

than those to which human populations are

exposed. Consequently, ingestion of fluoride

at current concentrations should have no

adverse effects on human reproduction.

6. Developmental toxicity. A

developmental toxicity study was

performed with cryolite in rats (MRID

00128112) at dose levels of 0, 750,

1,500, and 3,000 mg/kg/day (gavage).

The NOEL for both developmental and

maternal toxicity was 3,000 mg/kg/day.

At this dose level, the only observation

was whitening of the teeth of dams. A

developmental toxicity study was

conducted in female mice (MRID

42297902) with cryolite at dose levels of

0, 30, 100, and 300 mg/kg/day (gavage).

The NOEL for maternal toxicity was 30

mg/kg/day and the LOEL was 100 mg/

kg/day based on a single mortality in

this group. Fetuses at 300 mg/kg/day

exhibited bent ribs and bent limb bones.

The NOEL for developmental toxicity

was 100 mg/kg/day. The LOEL was 300

mg/kg/day based on an increase in bent

ribs and bent limbs. A range-finding

developmental toxicity study in female

rabbits (MRID 42297901) tested cryolite

at dose levels of 0, 10, 30, 100, 300, and

1,000 mg/kg/day (gavage). The NOEL for

maternal toxicity was determined to be

10 mg/kg/day and the LOEL was 30 mg/

kg/day based on an increased incidence

of soft stool and dark colored feces and

decreased defecation and urination. The

NOEL for developmental toxicity was 30

mg/kg/day. The developmental LOEL

could not be assessed due to excessive

maternal toxicity at dose levels of > 30

mg/kg/day.

7. Metabolism/metabolite toxicity. As

noted in the May 8, 1996 Federal

Register and reiterated in the RED,

cryolite behaves toxicologically as free

fluoride. That is, dissociation produces

free fluoride ions which are assimilated

into bone. There are numerous

references in the open literature

concerning the metabolism of cryolite

and other fluoride salts. The National

Research Council concluded in their

1993 comprehensive report entitled

‘‘Health Effects of Ingested Fluoride’’

that fluoride is readily absorbed by the

gut and rapidly becomes associated with

teeth and bones. The remaining fluoride

is eliminated almost exclusively by the

kidneys with the rate of renal clearance

related directly to urinary pH.

8. Endocrine effects. The twogeneration rat reproduction study, the

rat, rabbit and mouse developmental

studies and the dog chronic studies

summarized above did not demonstrate

any effects with cryolite that are similar

to those produced by naturally

occurring estrogens, or other endocrine

effects. No endocrine effects were

determined in the rat and mouse NTP

studies.

In addition, it should be noted that

national and international regulatory

organizations (U.S. EPA Office of Water,

U.S. DHHS, the Canadian Government,

and the World Health Organization)

have assessed potential health risks

from exposure to fluoride. EPA has

concluded that the endpoints and

estimated effect levels documented by

these organizations are similar and that

the health effects of fluoride in animals

and humans include dental and skeletal

fluorosis. Endocrine effects have not

been recognized as toxicological

endpoints for fluoride by any

worldwide regulatory authority.

C. Aggregate Exposure

1. Dietary exposure-food. As noted in

the May 8, 1996 Federal Register and

reiterated in the RED, the Agency has

estimated dietary exposure to cryolite

using reassessed tolerances for all crops

(including the proposed tolerances for

potatoes) and percent of crop treated

assumptions. In the RED, EPA estimated

dietary exposure to cryolite from all

crops to be approximately 0.020 mg/kg/

day for the U.S. population, 0.024 mg/

kg/day for children 1-6, 0.015 mg/kg/

day for children 7-12, and 0.028 mg/kg/

day for nursing females 13+ years. For

the highest exposed subgroup (females

20 years old and over), the Agency

estimated exposure of 0.038 mg/kg/day

(61 FR 20781). The Agency estimated

dietary exposure resulting from the

specific use of cryolite on potatoes to be

approximately 0.00016 mg/kg/day. The

Task Force believes that these exposure

estimates in fact overstate actual dietary

exposure since cryolite tolerance levels,

rather than residues actually present at

the consumer level were used by EPA in

the exposure assessments.

2. Dietary exposure- drinking water.

In the Environmental Fate Assessment

conducted for the RED, the Agency

concluded that the use of cryolite

should have negligible impacts on

fluoride levels in ground and surface

water. For this reason, the contribution

of cryolite to potential exposure to

fluoride from drinking water need not

be considered in the aggregate risk

assessment.

However, fluoride is intentionally

supplemented to drinking water for

prevention of dental caries and may also

be present at natural background levels.

The U.S. Public Health Service

recommends an optimal fluoride

concentration of 0.7 to 1.2 mg/L to

prevent dental caries and minimize

dental fluorosis.

Fluoride levels in public drinking

water are regulated under the Safe

Drinking Water Act. A Maximum

Concentration Limit (MCL) of 4.0 mg/L

(0.114 mg/kg/day) has been established.

EPA has previously estimated that

levels of fluoride in/on food from the

agricultural use of cryolite plus fluoride

levels in U.S. drinking water supplies

results in a daily dietary intake of

fluoride of approximately 0.095 mg/kg/

day. This is substantially less than the

Maximum Concentration Limit (MCL) of

4.0 mg/L (0.144 mg/kg/day), a level

which provides no known or

anticipated adverse health effect as

determined by the Surgeon General.

As noted in the May 8, 1996 Federal

Register and reiterated in the RED, the

Agency has concurred with the findings
Federal Register / Vol. 62, No. 48 / Wednesday, March 12, 1997 / Notices 11441

of the Surgeon General that adverse

health effects have not been found in

the U. S. population below 8 mg F/L

(0.23 mg/kg/day).

3. Non-dietary exposure. Cryolite is

used almost exclusively as an

agricultural crop protection insecticide.

Conceivably, cryolite also could be used

in outdoor homeowner/residential sites

for insect control in ornamentals and

shade trees. Cryolite is not registered for

either lawn or crack and crevice

treatments. EPA concluded in the RED

that a post-application exposure

assessment for cryolite (including both

occupational and residential exposure)

was not appropriate since no

toxicological endpoints relevant to nondietary exposure have been identified

for cryolite. The Task Force concludes

that non-dietary exposure represents a

negligible component of potential

aggregate exposure to cryolite and need

not be considered in the aggregate risk

assessment.

D. Cumulative Effects

The residue of toxicological concern

in cryolite is fluoride. Although fluoride

supplements in drinking water are not

considered to be pesticidal substances,

the dietary contribution of drinking

water to overall fluoride exposure has

been discussed elsewhere in this

summary. Current tolerances for

insecticidal fluorine-containing

compounds are limited to cryolite and

synthetic cryolite. For this reason,

consideration of potential cumulative

effects of residues from pesticidal

substances other than sodium

aluminofluoride with a common

mechanism of toxicity are not

applicable.

E. Safety Determination

1. U.S. population. As discussed

above, non-dietary exposure to cryolite

is negligible. For dietary exposure, EPA

has concluded that rather than

establishing a traditional Reference Dose

(RfD), a weight-of-the-evidence risk

assessment is a more appropriate

approach for cryolite. The toxicological

endpoint of concern for dietary

exposure to cryolite is skeletal fluorosis.

EPA has approximated that total dietary

fluoride levels in food plus drinking

water is 0.095 mg/kg/day. Of this total

exposure, the dietary (food) contribution

is about 0.020 mg/kg/day for the U.S.

population, and 0.038 mg/kg/day for the

highest exposed subgroup (females 20

years old and over). The proposed

potato tolerances have been estimated

by EPA to contribute approximately

0.00016 mg/kg/day to total dietary

exposure. These exposure estimates

likely overstate actual dietary exposure,

since marketbasket residue levels for

cryolite have not been considered. As

noted above, the Agency has concurred

with the findings of the Surgeon General

that adverse health effects (skeletal

fluorosis) have not been found in the

U.S. population below 8 mg F/L (0.23

mg/kg/day).

2. Infants and children. EPA has

concluded previously that in rats, the

developmental NOEL for cryolite is

3,000 mg/kg/day (1,584 mg/kg/day F),

that in mice, the developmental NOEL

is 100 mg/kg/day (52.8 mg/kg/day F),

and that in rabbits, the developmental

NOEL is 30 mg/kg/day (15.8 mg/kg/day

F). The NOEL for reproductive toxicity

of cryolite determined in a 2-generation

rat reproduction study was determined

by the Agency to be 46 mg/kg/day (24.3

mg/kg/day F).

These data show clearly that no

additional margin of safety is required

for exposure of infants and children to

cryolite. The developmental NOEL

ranges from more than 166x (rabbit) to

more than 16,000x (rat) for the

maximum combined exposure of infants

and children to residues of fluoride

from all agricultural uses of cryolite

plus drinking water. The reproductive

NOEL is about 256x greater than

maximum combined exposure of infants

and children to residues of fluoride.

F. International Tolerances

No Codex, EC or other international

tolerances are in effect for cryolite; thus,

potential dietary exposure to fluoride

from the agricultural use of cryolite on

crops would not include imported

foodstuffs.

II. Public Record

A record has been established for this

notice under docket control number

[PF–712] (including comments and data

submitted electronically as described

below). A public version of the 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 public

record is located in Room 1132 of the

Public Response and Resources Branch,

Field Operations Division (7506C),

Office of Pesticide Programs,

Environmental Protection Agency,

Crystal Mall #2, 1921 Jefferson Davis

Highway, Arlington, VA.

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.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer all comments received

electronically into printed, paper form

as they are received and will place the

paper copies in the official rulemaking

record which will also include all

comments submitted directly in writing.

The official rulemaking record is the

paper record maintained at the address

in ‘‘ADDRESSES’’ at the beginning of

this document.

List of Subjects

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: February 24, 1997.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

[FR Doc. 97–6015 Filed 3–11–97; 8:45 am]

BILLING CODE 6560–50–F

[PF–715; FRL–5589–6]

Zeneca Ag Products; Pesticide

Tolerance Petition Filing

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of filing.

SUMMARY: This notice announces the

initial filing of three pesticide petitions

proposing the establishment of

tolerances for residues of azoxystrobin

(not accepted by ANSI) in or on raw

agricultural commodities of grape

(pesticide petition (PP) 5F4541), pecan

(PP 6F4642), and tomato, peach, banana,

peanut, and wheat (PP 6F4762). This

notice includes a summary of the

petitions that was prepared by the

petitioner, Zeneca Ag Products.

DATES: Comments, identified by the

docket control number [PF–715], must

be received on or before, April 11, 1997.

ADDRESSES: By mail, submit written

comments to Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

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

Washington, DC 20460. In person, bring

comments to Rm. 1132, CM #2, 1921

Jefferson Davis Highway, Arlington, VA

22202. Comments and data may also be

submitted electronically by sending

electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Electronic

comments must be submitted as an

ASCII file avoiding the use of special

characters and any form of encryption.