42546 Federal Register / Vol. 62, No. 152 / Thursday, August 7, 1997 / Notices

Transmission Service Tariff, FERC

Original Volume No. 11.

Comment date: August 14, 1997, in

accordance with Standard Paragraph E

at the end of this notice.

21. Black Hills Corporation

[Docket No. ER97–3711–000]

Take notice that on July 14, 1997,

Black Hills Corporation, which operates

its electric utility business under the

assumed name of Black Hills Power and

Light Company (Black Hills), tendered

for filing an executed Form Service

Agreement with Rainbow Energy

Marketing Corporation.

Copies of the filing were provided to

the regulatory commission of each of the

states of Montana, South Dakota, and

Wyoming.

Black Hills has requested that further

notice requirement be waived and the

tariff and executed service agreements

be allowed to become effective June 23,

1997.

Comment date: August 14, 1997, in

accordance with Standard Paragraph E

at the end of this notice.

22. Central Hudson Gas and Electric

Corporation

[Docket No. ER97–3712–000]

Take notice that on July 14, 1997,

Central Hudson Gas and Electric

Corporation (CHG&E), tendered for

filing pursuant to 35.12 of the Federal

Energy Regulatory Commission’s

(Commission) Regulations in 18 CFR a

Service Agreement between CHG&E and

Entergy Power Marketing Corporation.

The terms and conditions of service

under this Agreement are made

pursuant to CHG&E’s FERC Electric Rate

Schedule, Original Volume No. 1

(Power Sales Tariff) accepted by the

Commission in Docket No. ER97–890–

000. CHG&E also has requested waiver

of the 60-day notice provision pursuant

to 18 CFR 35.11.

A copy of this filing has been served

on the Public Service Commission of the

State of New York.

Comment date: August 14, 1997, in

accordance with Standard Paragraph E

at the end of this notice.

23. Central Hudson Gas & Electric

Corporation

[Docket No. ER97–3713–000]

Take notice that on July 14, 1997,

Central Hudson Gas & Electric

Corporation (CHG&E), tendered for

filing pursuant to 35.12 of the Federal

Energy Regulatory Commission’s

(Commission) Regulations in 18 CFR a

Service Agreement between CHG&E and

Delmarva Power & Light Company. The

terms and conditions of service under

this Agreement are made pursuant to

CHG&E’s FERC Open Access Schedule,

Original Volume No. 1 (Transmission

Tariff) filed in compliance with the

Commission’s Order No. 888 in Docket

No. RM95–8–000 and RM94–7–001.

CHG&E also has requested waiver of the

60-day notice provision pursuant to 18

CFR 35.11.

A copy of this filing has been served

on the Public Service Commission of the

State of New York.

Comment date: August 14, 1997, in

accordance with Standard Paragraph E

at the end of this notice.

24. Bruce Demars

[Docket No. ID–3057–000]

Take notice that on July 15, 1997,

Bruce Demars (Applicant) tendered for

filing an application under Section

305(b) of the Federal Power Act to hold

the following positions:

Director—Commonwealth Edison

Company

Director—McDermott International, Inc.

Comment date: August 15, 1997, in

accordance with Standard Paragraph E

at the end of this notice.

25. Deseret Generation & Transmission

Cooperative

[Docket No. OA97–675–000]

Take notice that Deseret Generation

and Transmission Cooperative (Deseret)

on July 14, 1997, tendered for filing a

transmission tariff in compliance with

the Commission’s Order No. 888–A.

Deseret asks the Commission to set an

effective date for the tariff of October 16,

1996.

Copies of the filing were served upon

Deseret’s member cooperatives and

customers.

Comment date: August 15, 1997, in

accordance with Standard Paragraph E

at the end of this notice.

26. Upper Peninsula Power Company

[Docket No. OA97–676–000]

Take notice that on July 14, 1997,

Upper Peninsula Power Company

(UPPCO) tendered for filing a revised

open access transmission tariff in

accordance with FERC Order No. 888–

A. UPPCO states that the revised tariff

supersedes in its entirety an open access

transmission tariff in the form

prescribed by FERC Order No. 888 that

was previously filed in Docket No.

OA97–523–000. UPPCO has proposed to

make its revised tariff effective as of July

14, 1997 or such later date as may be

prescribed by the Commission for the

effectiveness of tariffs conforming to

FERC Order No. 888–A.

Comment date: August 15, 1997, in

accordance with Standard Paragraph E

at the end of this notice.

27. PJM Interconnection, L.L.C.

[Docket No. OA97–678–000]

Take notice that on July 14, 1997, PJM

Interconnection, L.L.C. (PJM), on behalf

of Atlantic City Electric Company,

Baltimore Gas and Electric Company,

Delmarva Power & Light Company,

Jersey Central Power & Light Company,

Metropolitan Edison Company,

Pennsylvania Electric Company, PECO

Energy Company, Pennsylvania Power &

Light Company, Potomac Electric Power

Company and Public Service Electric

and Gas Company, tendered for filing

revisions to the PJM Open Access Tariff

to comply with the requirements of

Order No. 888–A.

Copies of this filing were served upon

the regulatory commissions of Delaware,

the District of Columbia, Maryland, New

Jersey, Pennsylvania, and Virginia,

members of the PJM Interconnection,

LLC, and entities with transmission

service agreements under the PJM Tariff.

Comment date: August 15, 1997, in

accordance with Standard Paragraph E

at the end of this notice.

Standard Paragraph

E. Any person desiring to be heard or

to protest said filing should file a

motion to intervene or protest with the

Federal Energy Regulatory Commission,

888 First Street, N.E., Washington, D.C.

20426, in accordance with Rules 211

and 214 of the Commission’s Rules of

Practice and Procedure (18 CFR 385.211

and 18 CFR 385.214). All such motions

or protests should be filed on or before

the comment date. Protests will be

considered by the Commission in

determining the appropriate action to be

taken, but will not serve to make

protestants parties to the proceeding.

Any person wishing to become a party

must file a motion to intervene. Copies

of this filing are on file with the

Commission and are available for public

inspection.

Lois D. Cashell,

Secretary.

[FR Doc. 97–20799 Filed 8–6–97; 8:45 am]

BILLING CODE 6717–01–P

ENVIRONMENTAL PROTECTION

AGENCY

[PF–750; FRL–5727–3]

Pesticide Tolerance Petition; Notice of

Filing

AGENCY: Environmental Protection

Agency (EPA)
Federal Register / Vol. 62, No. 152 / Thursday, August 7, 1997 / Notices 42547

ACTION: Notice of filing.

SUMMARY: This notice announces the

filing of a pesticide petition proposing

regulations amending the established

tolerances for residues of the

insecticidal fluorine compounds

cryolite and/or synthetic cryolite

(sodium aluminum fluoride or sodium

aluminofluoride) in or on cabbage,

citrus fruits, collards, eggplant, lettuce,

peaches, and tomatoes; and establishing

tolerances for the processed foods,

raisins and tomato paste. 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–750]. must

be received on or before September 8,

1997.

ADDRESSES: By mail submit written

comments to: Public Information and

Records Integrity Branch, Information

Resources and Services 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.

Comments and data may also be

submitted electronically by following

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: Jackie Mosby (7505C), 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. 203, CM #2, 1921

Jefferson Davis Highway, Arlington, VA,

(703) 305–6792, e-mail: mosbyromney.jackie@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 by: (1)

Increasing the established tolerances for

residues of the insecticidal fluorine

compounds cryolite and /or synthetic

cryolite in or on the agricultural

commodities as listed below; (2)

establishing separate tolerances for the

residues in or on head and leaf lettuce;

and (3) establishing tolerances for the

residues in the processed foods, raisins

at 55 ppm, and tomato paste at 45 ppm.

Commodity Current Proposed

cabbage 7 ppm 45 ppm

citrus fruits 7 ppm 95 ppm

collards 7 ppm 35 ppm

eggplant 7 ppm 30 ppm

lettuce 7 ppm

lettuce, head 180 ppm

lettuce, leaf 40 ppm

peaches 7 ppm 10 ppm

raisins none 55 ppm

tomatoes 7 ppm 30 ppm

tomato paste none 45 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, 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.

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–750

(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 file format or ASCII file

format. All comments and data in

electronic form must be identified by

the docket control number PF–745 and

appropriate petition number. Electronic

comments on this notice may be filed

online at many Federal Depository

Libraries.

List of Subjects

Environmental Protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: July 31, 1997.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

Summary of Petition

This informative summary is

submitted by the Cryolite Task Force

(Consortium No. 62569), under section

408 of FFDCA, as most recently

amended by FQPA. The Cryolite Task

Force is comprised of Elf Atochem

North America and Gowan Company.

The Cryolite Task Force previously has

petitioned the Agency to amend

tolerances for residues of cryolite and/

or synthetic cryolite (sodium

aluminofluoride) in or on the raw

agricultural commodities: lettuce (head),

lettuce (leaf), cabbage, collards,

eggplant, tomatoes, citrus (crop group)

and peaches and to establish tolerances

for residues of cryolite in processed

foods: raisins and tomato paste. EPA

approved these new and revised

tolerances in the Cryolite Reregistration

Eligibility Decision (RED) and noted its

intent to propose these in the Federal

Register. However, prior to publication

of the new regulations, FQPA specified

additional requirements for tolerance

petitions. The purpose of this

submission is to provide the additional

information specified in the FQPA.
42548 Federal Register / Vol. 62, No. 152 / Thursday, August 7, 1997 / Notices

Cryolite Task Force

PP 5F4599

A. Residue Data

1. Name, identity, and composition of

the residue. Cryolite (sodium

aluminofluoride, sodium

hexafluoroaluminate, or sodium

aluminum fluoride) is a fluorine

containing insecticide which is found in

naturally occuring 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 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.

Magnitude of the residue in plants.

Residue data covering all of the uses

associated with the RAC tolerances

requested by this petition have been

reviewed and approved by the Agency

(see the Cryolite RED, pages 19 - 26).

The proposed tolerance amendments are

summarized, below:

Lettuce (head) - 180 ppm

Lettuce (leaf) - 40 ppm

Cabbage - 45 ppm

Collards - 35 ppm

Eggplant - 30 ppm

Tomato - 30 ppm

Citrus fruit group - 95 ppm

Peaches - 10 ppm

2. Magnitude of the residue in

processed food/feed. As documented in

the RED, EPA has concluded that

acceptable processing studies support

the proposed tolerances of 45 ppm for

tomato paste and 55 ppm for raisins.

3. Directions for use. Use directions

consistent with the proposed revised

RAC and new processed food tolerances

have been approved by the Agency.

Labeling was approved by EPA for the

Gowan registration (10163-41) on May

10, 1995. Labeling was approved for the

Atochem registration (4581-116) on

October 26, 1995.

4. Analytical method. EPA concluded

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 the Pesticide Analytical

Manual, 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 occuring fluoride and fluoride

resulting from agricultural use of

cryolite. Current FDA multi-residue

screening protocols are not appropriate

for inorganic fluoride residues.

5. Practical methods for removing

residues. Plant residues are inorganic

surface residues of cryolite. Data

reviewed by EPA for the RED show that

washing, peeling, and trimming are

effective methods of removing these

residues.

6. Plant metabolism. EPA concluded

in the cryolite RED that the qualitative

nature of the residue in plants is

understood and that plant residues are

inorganic surface residues of cryolite

which are measured as fluoride.

7. Animal metabolism. EPA

concluded 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.

8. Magnitude of the residue in meat,

milk, poultry and eggs. EPA concluded

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 supports a

reregistration eligibility decision for

numerous crops, including head lettuce,

leaf lettuce, cabbage, collards, eggplant,

tomatoes, citrus (crop group), grapes,

and peaches. 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
Federal Register / Vol. 62, No. 152 / Thursday, August 7, 1997 / Notices 42549

at dose levels up to and including 50 μg/

ml.

4. Chronic toxicity. The Agency

concluded in the cryolite RED that the

available information does not support

the regulation of cryolite insecticides as

carcinogens. EPA 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 Federal Register of May 8,

1996, 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

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, 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 one male of fifty (1/50) in the

100 ppm group and in three of eighty (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 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 may 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.

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 urine

specific 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

threshhold 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 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

developmental toxicity studies in rats,

rabbits and mice and the dog chronic

study summarized above did not
42550 Federal Register / Vol. 62, No. 152 / Thursday, August 7, 1997 / Notices

demonstrate any effects with cryolite

that are similar to those produced by

naturally occuring 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 RED, the Agency has estimated

dietary exposure to cryolite using

reassessed tolerances for all crops

(including the proposed tolerances

discussed in this petition) 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 ages 1 to 6, 0.015 mg/kg/day

for children ages 7 to 12 and 0.028 mg/

kg/day for the highest exposed subgroup

(nursing females 13+ years). The Task

Force believes that these exposure

estimates in fact greatly 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 - 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 estimated previously 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 RED, the Agency has

concurred with the findings 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 nondietary 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. As stated in the RED, the

OPP’s Health Effects Division’s RfD Peer

Review Committee concluded that ‘‘For

acute dietary exposure, no endpoint of

concern could be found from which an

acute dietary risk assessment. . .should

be conducted.’’ There was no endpoint

for acute dietary exposure since acute

toxicity in animal studies is absent until

very high doses of cryolite were used.

For chronic dietary exposure to cryolite,

EPA has concluded that rather than

establishing a traditional Reference Dose

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

assessment is a more appropriate

approach. The endpoint for chronic

dietary exposure is skeletal fluorosis. As

part of the RED decision for cryolite,

EPA conducted a chronic exposure

analysis using the Dietary Risk

Evaluation System (DRES). This

analysis was performed using the

proposed tolerances that are the subject

of this petition. The Agency 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 0.028 mg/kg/day for the highest

exposed subgroup. 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
Federal Register / Vol. 62, No. 152 / Thursday, August 7, 1997 / Notices 42551

crops would not include imported

foodstuffs.

[FR Doc. 97–20845 Filed 8–6–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[FRL–5872–1]

Agency Information Collection

Activities Under OMB Review

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

Office of Management and Budget’s

(OMB) responses to Agency clearance

requests, in compliance with the

Paperwork Reduction Act (44 U.S.C.

3501 et. seq.). An agency may not

conduct or sponsor, and a person is not

required to respond to, a collection of

information unless it displays a

currently valid OMB control number.

The OMB control numbers for EPA’s

regulations are listed in 40 CFR Part 9

and 48 CFR Chapter 15.

FOR FURTHER INFORMATION CONTACT:

Sandy Farmer (202) 260–2740, please

refer to the appropriate EPA Information

Collection Request (ICR) Number.

SUPPLEMENTARY INFORMATION:

OMB Responses to Agency Clearance

Requests

OMB Approvals

EPA ICR No. 0916.07; Renewal—

Annual Updates of Emission Data to the

Aerometic Information Retrieval System

(AIRS); was approved 06/11/97; OMB

No. 2060–0088; expires 10/31/97.

EPA ICR No. 1726.02; Marine Engine

Manufacturer In-Use Emission Testing

Program; was approved 07/16/97; OMB

No. 2060–0322; expires 07/31/2000.

EPA ICR No. 1725.02; Marine Engine

Manufacturers Production Line Testing

Reporting and Recordkeeping

Requirements; was approved 07/16/97;

OMB No. 2060–0323; expires 07/31/

2000.

EPA ICR No. 1724.02 Marine

Selective Enforcement Auditing

Reporting and Recordkeeping

Requirements; was approved 07/16/97;

OMB No. 2060–0319; expires 07/31/

2000.

EPA ICR No. 1799.01; NESHAP for

Recordkeeping and Reporting

Requirements for the Mineral Wool

Production; was approved 07/16/97;

OMB No. 2060–0362; expires 07/31/

2000.

EPA ICR No. 0282.09; Motor Vehicle

Emission Defect Information; was

approved 07/16/97; OMB No. 2060–

0048; expires 07/31/2000.

EPA ICR No. 1792.01; Environmental

Protection Agency/Chemical

Manufacturers Association Root-Cause

Analysis Pilot Project; was approved 07/

18/97; OMB No. 2020–0008; expires 07/

31/2000.

EPA ICR No. 1781.01 NESHAP for

Pollutants for Pharmaceuticals

Production; was approved 07/17/97;

OMB No. 2060–0358; expires 07/31/

2000.

EPA ICR No. 0095.09; Precertification

and Testing Exempting Reporting and

Recordkeeping Requirements; was

approved 07/17/97; OMB No. 2060–

0007; expires 07/31/2000.

EPA ICR No. 1591.07; Standard for

Reformulated Gasoline; was approved

07/16/97; OMB No. 2060–0227; expires

07/31/2000.

Extensions of Expiration Dates

EPA ICR No. 0234.05; Performance

Evaluation Studies on Water and

Wastewater Laboratories; OMB No.

2080–0021; expiration date was

extended from 07/31/97 to 10/31/97.

EPA ICR No. 1703.01; Radon

Measurement Protocol Evalution Study;

OMB No. 2060–0303; expiration date

was extended from 11/30/97 to 01/31/

98.

Dated: July 31, 1997.

Joseph Retzer,

Division Director, Regulatory Information

Division.

[FR Doc. 97–20826 Filed 8–6–97; 8:45 am]

BILLING CODE 6560–50–M

ENVIRONMENTAL PROTECTION

AGENCY

[FRL–5871–6]

Proposed Prospective Purchaser

Agreement Under the Comprehensive

Environmental Response,

Compensation and Liability Act

AGENCY: Environmental Protection

Agency.

ACTION: Notice of a Prospective

Purchaser Agreement and Covenant Not

to Sue Rosey’s Pit Cleaning, Camden,

New Jersey for a Property Within the

Welsbach/General Gas Mantle

Contamination Site.

SUMMARY: The United States

Environmental Protection Agency (EPA)

is proposing to enter into a Prospective

Purchaser Agreement to provide Rosey’s

Pit Cleaning, Camden, New Jersey, a

covenant not to sue under the

Comprehensive Environmental

Response Compensation and Liability

Act of 1980 (CERCLA), as amended, in

connection with its proposed purchase

and development of a property related

to general contamination from the

former Gas Mantle facility. This

agreement is intended to resolve a

potentially responsible party’s liability

for certain response costs incurred and

to be incurred by EPA at the Welsbach/

General Gas Mantle Contamination

Superfund Site in Camden, New Jersey.

Notice is being published to inform the

public of the Proposed Prospective

Purchaser Agreement and of the

opportunity to comment.

DATE: Comments must be provided on or

before September 8, 1997.

ADDRESS: Comments should be

addressed to the U.S. Environmental

Protection Agency, Office of Regional

Counsel, 290 Broadway—17th Floor,

New York, NY 10007 and should refer

to: In the Matter of the Welsbach/

General Gas Mantle Contamination

Superfund Site: Rosey’s Pit Cleaning,

Camden, New Jersey, U.S. EPA Index

No. II–CERCLA–97–0113.

FOR FURTHER INFORMATION CONTACT: U.S.

Environmental Protection Agency,

Office of Regional Counsel, 290

Broadway—17th Floor, New York, NY

10007, Attention: Virginia Curry, Esq.

(212) 637–3134.

SUPPLEMENTARY INFORMATION: Notice is

hereby given of a Proposed Prospective

Purchaser Agreement with Rosey’s Pit

Cleaning, Camden, New Jersey,

resolving the company’s potential

liability for a property within the

Welsbach/General Gas Mantle

Contamination Superfund Site. CERCLA

authorizes EPA to enter into this

agreement. The Department of Justice

approved this agreement pursuant to the

inherent settlement authority of the

Attorney General to settle claims of the

United States.

A copy of the Proposed Prospective

Purchaser Agreement may be obtained

by mail from EPA’s Region II Office of

Regional Counsel, 290 Broadway—17th

Floor, New York, NY 10007.

Proposed Prospective Purchaser

Agreement under CERCLA—Welsbach/

General Gas Mantle Contamination

Superfund Site.

Dated: June 30, 1997.

Jeanne M. Fox,

Regional Administrator.

[FR Doc. 97–20823 Filed 8–6–97; 8:45 am]

BILLING CODE 6560–50–P