Federal Register / Vol. 61, No. 90 / Wednesday, May 8, 1996 / Proposed Rules 20781

4:30 p.m., Monday through Friday,

excluding legal holidays. The public

record is located in Room 1132 of the

Public Response and Program Resources

Branch, Field Operations Division

(7506C), Office of Pesticide Programs,

Environmental Protection Agency, CM

#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.

The Office of Management and Budget

has exempted this document from the

requirement of review pursuant to

Executive Order 12866. In addition, this

action does not impose any enforceable

duty, or contain any ‘‘unfunded

mandates’’ as described in Title II of the

Unfunded Mandates Reform Act of 1995

(Pub. L. 104–4), or require prior

consultation as specified by Executive

Order 12875 (58 FR 58093, October 28,

1993), entitled Enhancing the

Intergovernmental Partnership, or

special considerations as required by

Executive Order 12898 (59 FR 7629,

February 16, 1994).

Pursuant to the requirements of the

Regulatory Flexibility Act (Pub. L. 96–

354, 94 Stat. 1164, 5 U.S.C. 601–612),

the Administrator has determined that

regulations establishing new tolerances

or raising tolerance levels or

establishing exemptions from tolerance

requirements do not have a significant

economic impact on a substantial

number of small entities. A certification

statement to this effect was published in

the Federal Register of May 4, 1981 (46

FR 24950).

List of Subjects

40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

40 CFR Part 185

Food additives, Pesticides and pest.

40 CFR Part 186

Animal feeds, Pesticides and pest.

Dated: April 26, 1996.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, it is proposed that 40 CFR

part 180 be amended as follows:

PART 180—[AMENDED]

. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 346a and 371.

2. In § 180.449, by revising paragraph

(a), to read as follows:

§ 180.449 Avermectin B1 and its deltal-8,9-

isomer; tolerances for residues.

(a) Tolerances are established for the

combined residues of the insecticide

avermectin B1 (a mixture of avermectins

containing greater that or equal to 80%

avermectin B1a (5-0-dimethyl

avermcetin A1a) and less than or equal

to 20% avermectin B1b (5-0-demethyl25-de(1-methylpropyl)-25-(1-

methylethyl) avermectin A1a)) and it

delta-8,9-isomer in or on the following

commodities:

Commodity Parts per

million

Expiration

Date

Cattle, fat ......... 0.015 November

15, 1997

Cattle, meat ..... 0.02 November

15, 1997

Cattle, mybp .... 0.02 November

15, 1997

Citrus, whole

fruit.

0.02 November

15, 1997

Cottonseed ...... 0.005 November

15, 1997

Hops, dried ...... 0.5 December

31, 1996

Milk .................. 0.005 November

15, 1997

* * * * *

PART 185—[AMENDED]

2. In Part 185:

a. The authority citation for Part 185

continues to read as follows:

Authority: 21 U.S.C. 348

b. Section 185.300 is revised to read

as follows:

§ 185.300 Avermectin B1 and its delta-8,9

isomer; tolerances for residues.

Tolerances to expire on November 15,

1997 are established for the combined

residues of theinsecticide avermectin B1

(a mixture of avermectins containing

greater that or equal to 80% avermectin

B1a(5-0-dimethyl avermcetin A1a) and

less than or equal to 20% avermectin

B1b(5-0-demethyl-25-de(1-

methylpropyl)-25-(1-

methylethyl)avermectin A1a)) and it

delta-8,9-isomer in or on the following

commodity:

Commodity Parts per

million

Citrus Oil ................................... 0.10

PART 186—[AMENDED]

3. In part 186:

a. The authority citation for part 186

continues to read as follows:

Authority: 21 U.S.C. 348.

b. In § 186.300 by revising paragraph

(a) to read as follows:

§ 186.300 Avermectin B1 and its delta-8,9-

isomer; tolerances for residues.

(a) Tolerances to expire on November

15, 1997 are established for the

combined residues of the insecticide

avermectin B1 (a mixture of avermectins

containing greater that or equal to 80%

avermectin B1a (5-0-dimethyl

avermcetin A1a) and less than or equal

to 20% avermectin B1b (5-0-demethyl25-de(1-methylpropyl)-25-(1-

methylethyl) avermectin A1a)) and it

delta-8,9-isomer in or on the following

commodity:

Commodity Parts per

million

Dried Citrus pulp ....................... 0.10

* * * *

*

[FR Doc. 96–11342 Filed 5–7–96; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Parts 180 and 186

[PP 9F3739 FAP 1H5604/P654; FRL–5362–

6]

RIN 2070–AC18

Fluorine Compounds; Pesticide

Tolerance and Feed Additive

Regulation

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA proposes to establish a

pesticide tolerance for residues of the

insecticidal fluorine compounds

cryolite and/or synthetic cryolite

(sodium aluminum fluoride) in or on
20782 Federal Register / Vol. 61, No. 90 / Wednesday, May 8, 1996 / Proposed Rules

the raw agricultural commodity potatoes

at 2.0 parts per million (ppm) and a feed

additive regulation for the animal feed

commodity, potato waste resulting from

the processing of treated potatoes at 22.0

ppm. The proposed tolerance and

regulation to establish maximum

permissible levels for residues of the

pesticide in or on the commodities were

requested in petitions submitted by

Attochem North America, Inc.

DATES: Comments, identified by the

docket control number [PP 9F3739 and

FAP 1H5604/P654], must be received on

or before June 7, 1996.

ADDRESSES: Submit written comments

by mail 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: Public Docket, Rm. 1132,

Crystal Mall #2, 1921 Jefferson Davis

Highway, Arlington, VA.

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.

Comments and data will also be

accepted on disks in WordPerfect in 5.1

file format or ASCII file format. All

comments and data in electronic form

must be identified by the docket number

(PP 9F3739 and FAP 1H5604/P654). No

Confidential Business Information (CBI)

should be submitted through e-mail.

Electronic comments on this proposed

rule may be filed online at many Federal

Depository Libraries. Additional

information on electronic submissions

can be found below in this document.

Information submitted as a comment

concerning this document may be

claimed confidential by marking any

part or all of that information as CBI.

Information so marked will not be

disclosed except in accordance with

procedures as 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

will be included in the public docket by

EPA without prior notice. The public

docket is available for public inspection

in Rm. 1132 at the above address, from

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

Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: By

mail: Robert A. Forrest, Product

Manager (PM) 14, Registration Division

(7505C), 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,

(703) 305–6600, e-mail:

forrest.robert@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA

issued a notice, published in the

Federal Register of May 5, 1993 (58 FR

26687), which announced the

establishment of a 3-year time-limited

tolerance for residues of the insecticidal

fluorine compounds cryolite and

synthetic cryolite (sodium aluminum

fluoride) on potatoes and the

establishment of a 3-year time-limited

feed additive regulation for residues of

these compounds in processed potato

waste (wet or dry).

These regulations were established for

a period extending to May 6, 1996, to

cover residues existing from the

conditional registration of the

insecticidal compounds on potatoes

extending to September 30, 1995. The

Agency limited the period of time the

conditional registration and the

regulations were to be in effect because

of the lack of a chronic dog feeding

study and a two-generation rat

reproduction study. These two studies

have been received and have been found

to be acceptable.

Pesticide petition 9F3739 requests

that the Administrator, pursuant to

section 408(d) of the Federal Food,

Drug, and Cosmetic Act (FFDCA), 21

U.S.C. 346a(d), amend 40 CFR 180 by

establishing a tolerance for residues of

the insecticidal fluorine compounds in

or on the raw agricultural commodity

potatoes at 2.0 ppm with no time

limitations. Food additive petition

1H5604 requests that the Administrator,

pursuant to section 409(b) of the FFDCA

(21 U.S.C. 348), amend 40 CFR part 186

by establishing a feed additive

regulation for residues of the

insecticidal compounds in or on the

processed animal feed commodity

processed potato waste (wet or dry) at

22.0 ppm with no time limitations.

To meet the current definition, the

commodity, ‘‘processed potato waste

(wet or dry)’’ is corrected to read as

follows: potatoes, waste from

processing.

I. Background Information

Fluoride has been identified as the

residue of toxicological concern in

cryolite and synthetic cryolite and the

available data show that these

compounds which are approximately

52.8% fluoride, act as free fluoride.

Fluoride is ubiquitous and may be

present at low levels in air, soils and in

foodstuffs that have not been treated

with cryolite and/or synthetic cryolite

as well as in drinking water. The

atmospheric levels of fluoride and

incidental dietary exposures to fluoride

as a toothpaste additive or as a dental

treatment contribute relatively little to

the average level of dietary fluoride

exposure and are not further considered

in the exposure estimate.

Data submitted in support of the

subject petition show background levels

of fluoride in untreated potatoes ranged

from 0.14 ppm to 0.31 ppm and are

consistent with the ranges reported in

the open literature. Levels of fluoride

found in the treated potatoes ranged

from 0.18 ppm to 0.94 ppm. The residue

analytical method used for enforcing the

subject tolerance and regulation cannot

distinguish between the naturally

occurring fluoride and the fluoride

resulting from use of cryolite and/or

synthetic cryolite.

Fluoride levels in public drinking

water are regulated under the Safe

Drinking Water Act. EPA has

established a Maximum Concentration

Limit (MCL) at 4.0 mg/L [0.114 mg/kg/

day] to protect against crippling skeletal

fluorosis (51 FR 11396, April 2, 1986).

The MCL established on April 2, 1986,

finalizes interim regulations set in

November 14, 1985 (50 FR 47142), and

proposed in the Federal Register of May

14, 1985 (50 FR 20164). In addition,

these FR notices established a

Secondary Maximum Contaminant

Level (SMCL) at 2.0 mg/L [0.057 mg/kg/

day] for cosmetic effects (objectionable

dental fluorosis) which are not

considered to be adverse health effects

by the Surgeon General.

The EPA Office of Drinking Water

issued a Drinking Water Criteria

Document on Fluoride (October 21,

1985) which presents summaries of

experimental and clinical data on the

health effects of fluoride in animals and

humans. In general, the health effects of

fluoride include dental fluorosis and

skeletal fluorosis.

At the request of the EPA, the U.S. Surgeon

General examined the nondental health

aspects associated with fluoride in drinking

water. The Surgeon General concluded that

he did not consider changes in bone density

to be an adverse health effect and that

adverse effects (arthralgias) are not likely to

occur at human dose levels below 20 mg F/

day (10 mg F/L for an adult consuming 2 L

water/day [0.29 mg/kg/day]). The ad hoc

committee concluded that four times the

optimal fluoride concentration

(approximately 4 mg F/L [0.114 mg/kg/day])

in drinking water should provide an

adequate margin of safety for preventing

adverse health effects which were not

documented to occur in the U.S. population

below 8 mg F/L [0.23 mg/kg/day]. (Water

Criteria Document p. IX–21).
Federal Register / Vol. 61, No. 90 / Wednesday, May 8, 1996 / Proposed Rules 20783

II. Toxicological Data

The scientific data submitted in the

petitions and other relevant material

have been evaluated. The toxicological

data considered in support of the

proposed tolerance and regulation

include:

1. A 2-year rat bioassay 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 only

observed in one male in the 100 ppm

group and in three males in the 175

ppm group. NTP considers this to be

equivocal evidence of carcinogenicity in

male F344/N rats. The NOEL is less than

25 ppm (1.3 mg/kg/day). The LOEL is 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. There

was ‘‘equivocal evidence’’ of

carcinogenic activity in male rats and

‘‘no evidence’’ of carcinogenic activity

in female rats.

The NTP study utilizing sodium

fluoride as the test material in lieu of

cryolite or synthetic cryolite satisfies the

guideline study requirement 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 the available data show that

these compounds act as free fluoride.

2. A 2-year mouse bioassay conducted

by the NTP utilizing 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 is less than 25 ppm (2.4

mg/kg/day). The LOEL is 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. There was ‘‘no evidence’’ of

carcinogenic activity in male and female

mice.

This study utilizing sodium fluoride

in lieu of cryolite or synthetic cryolite

as the test material satisfies the

guideline study requirement for a mouse

carcinogenicity study for the reason

described above under item one.

3. A 1-year chronic dog feeding study

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

1139 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 (in terms of cryolite) is less

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

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

LOEL is 3,000 ppm (95 mg/kg/day)

based on increases in emesis, nucleated

cells in males, renal lesions and a

decrease in urine specific gravity in

females.

4. A two-generation reproduction

study conducted with cryolite in the

diet of rats at 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.

5. A developmental toxicity study

conducted with cryolite in rats at dose

levels of 0, 750, 1,500, and 3,000 mg/kg/

day (gavage). The NOEL for both

developmental and maternal toxicity is

3,000 mg/kg/day. At this dose level, the

only observation was whitening of the

teeth of dams.

6. A developmental toxicity study

conducted in female mice with cryolite

at dose levels of 0, 30, 100 and 300 mg/

kg/day (gavage).

The NOEL for maternal toxicity is 30

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

day based on the occurrence of dark red

contents of the stomach.

Fetuses at 300 mg/kg/day exhibited

bent ribs and bent limb bones. The

NOEL for developmental toxicity is 100

mg/kg/day. The LOEL is 300 mg/kg/day

based on an increase in bent ribs and

bent limbs.

7. A range-finding developmental

toxicity study conducted in female

rabbits with cryolite at dose levels of 0,

10, 30, 100, 300 and 1,000 mg/kg/day

(gavage).

The NOEL for maternal toxicity is 10

mg/kg/day and the LOEL is 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 is 30

mg/kg/day. The LOEL could not be

assessed due to excessive toxicity at

dose levels of ≥30 mg/kg/day.

This study suggested that severe

maternal toxicity occurred at lower

doses than external developmental

toxicity. However, following an

extensive literature evaluation, the

National Research Council (National

Academy of Sciences Subcommittee of

Health Effects of Ingested Fluoride)

(NAS) determined that,

There have been reports of adverse effects

on reproductive outcomes associated with

high levels of fluoride intake 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. . . .

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.

Therefore, an additional

developmental study in rabbits is not

required.

8. A 28-day range-finding feeding

study conducted with cryolite in rats 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) with the only

compound related effect being a change

in coloration and physical property of

the teeth.

The NOEL was not determined. The

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

on dental fluorosis.

9. A 90-day rat feeding study

conducted with cryolite 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 is 50 ppm (3.8 mg/kg/day)

for effects other than fluoride

accumulation. The LOEL is 5,000 ppm

(399.2 mg/kg/day) based on lesions

observed in the stomach. Fluoride

accumulated at all dose levels.

10. A 90-day dog feeding study

conducted with cryolite 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 is 10,000 ppm (368 mg/kg/

day). The LOEL is 50,000 ppm (1,692

mg/kg/day) for effects other than

fluoride accumulation. Fluoride

accumulation occurred at all dose

levels.

11. Genotoxicity studies including an

Ames test (negative) at dose levels of

167, 500, 1,670, 5,000, 7,500 and 10,000

ug/plate; an in vitro assay in human

lymphocytes (negative) at 100, 500, and

1,000 ug/ml; and an unscheduled DNA

synthesis study in rat hepatocytes

(negative) at dose levels up to and

including 50 ug/ml.

12. Open literature studies showing

that human and animal metabolism of
20784 Federal Register / Vol. 61, No. 90 / Wednesday, May 8, 1996 / Proposed Rules

cryolite and/or synthetic cryolite

manifests itself as normal free fluoride

metabolism. That is, dissociation

occurs, producing free fluoride ions

which are assimilated into bone.

The available toxicity data are

considered adequate to support the

proposed regulations to establish

maximum permissible levels for

residues of the insecticidal fluorine

compounds in or on potatoes and in

processed potato waste.

The available information does not

support the regulation of the cryolite

insecticides as carcinogens.

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 than 50

epidemiological studies does not

support the hypothesis of an association

between fluoride exposure and

increased cancer risk in humans.’’ EPA

is in agreement with the conclusions

reached by the National Academy of

Science (NAS).

Rather than the establishment of the

traditional Reference Dose (RfD), a

weight-of-the-evidence risk assessment

was determined by the Agency to be a

more appropriate approach for the

assessment of the dietary exposure to

fluoride residues as a result of

agricultural uses of cryolite for the

following reasons:

• 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. The endpoints and estimated

effect levels documented by these

organizations are similar.

• The U.S. Surgeon General (Koop,

1984 and Elders, 1994) has

recommended a guideline level of

exposure that should provide an

adequate ‘‘margin of safety’’ based on a

large amount of human data, including

epidemiology studies.

• Animal data considered in

evaluating the proposed regulations are

consistent with human data with

respect to dose-related skeletal effects.

The weight-of-the-evidence dietary

risk assessment was conducted utilizing

the following factors. All calculations

are based on 2 L/day water consumption

and 70 kg adult.

• There exists no directly applicable

scientific documentation of adverse

medical effects at levels of fluoride

below 8 mg/L [0.23 mg/kg/day]. (U.S.

EPA. 1985. National Primary Drinking

Water Regulations; Fluoride. Proposed

Rulemaking. (50 FR 20166, May 14,

1985).

• Less than 0.4% of the U.S.

population (on public water supplies) is

exposed to greater than 2 mg/L fluoride

[0.057 mg/kg/day] in the public water

supply. (U.S. EPA. 1985. Drinking Water

Criteria Document on Fluoride. U.S.

EPA Office of Drinking Water,

Washington, D.C. TR–832–5. pg. IV–3,

Table IV–1.)

• Dietary exposure estimates using

reassessed tolerances including the

subject proposed tolerance and

regulation for potatoes and percent of

crops treated are approximately 0.029

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).

Therefore, it can be concluded 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 less than the Maximum

Concentration Limit (MCL) of 4.0 mg/L

[0.114 mg/kg/day], a level which

provides no known or anticipated

adverse health effect as determined by

the Surgeon General.

The estimated dietary exposure

resulting from the subject proposed

tolerance on potatoes is approximately

0.00016 mg/kg/day.

The metabolism of the subject

insecticides in plants and animals is

adequately understood. Plant residues

are inorganic surface residues of cryolite

which are measured as total fluoride.

Cryolite metabolism in animals

manifests itself as free fluorine

metabolism and the residue of concern

in animals is total fluoride.

An adequate analytical method

(fluoride specific electrode) is available

for enforcement purposes for the RAC

potatoes and the animal feed, potato

waste. Because the subject compounds

are inorganic compounds, the

requirement for data using the

multiresidue protocols in PAM Vol. I is

not applicable.

Because of the long lead time from

establishing this tolerance and

regulation to publication of the

enforcement methodology in the

Pesticide Analytical Manual, Vol. II, the

analytical methodology is being made

available in the interim to anyone

interested in pesticide enforcement

when requested from: Calvin Furlow,

Public Information Branch, Field

Operations Division (H7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. Office location

and telephone number; Rm. 1128, CM

#2, 1921 Jefferson Davis Hwy., VA

22202, (703)–305–5232.

There is no reasonable expectation of

finite residues of cryolite or synthetic

cryolite occurring in the meat, milk,

poultry, and eggs of animals fed potato

waste resulting from the processing of

treated potatoes and 40 CFR 180.6(a)(3)

applies. Thus, secondary tolerances are

not necessary at this time in meat, milk,

poultry, and eggs.

There are presently no actions

pending against the continued

registration of these insecticidal

compounds.

The pesticide is considered useful for

the purpose for which the tolerance is

sought and capable of achieving its

physical or technical effect.

Based on the information and data

considered, the Agency has determined

that the tolerance established by

amending 40 CFR part 180 would

protect the public health, and the

establishment of a feed additive

regulation by amending 40 CFR part 186

would be safe. Therefore, it is proposed

that they be established as set forth

below.

Any person who has registered or

submitted an application for registration

of a pesticide, under the Federal

Insecticide, Fungicide, and Rodenticide

Act (FIFRA) as amended, which

contains any of the ingredients listed

herein, may request within 30 days after

publication of this notice in the Federal

Register that this rulemaking proposal

as it relates to the section 408 tolerance

be referred to an Advisory Committee in

accordance with section 408(e) of the

FFDCA.

Interested persons are invited to

submit written comments on the

proposed regulation. Comments must

bear a notation indicating the document

control number, PP 9F3739 and FAP

1H5604/P. All written comments filed

in response to this petition will be

available in the Public Response and

Program Resources Branch at the above

address from 8 a.m. to 4:30 p.m.,

Monday through Friday, except legal

holidays.

A record has been established for this

proposal under docket number (PP

9F3739 and FAP 1H5604/P654)

(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 a.m. to

4:30 p.m., Monday through Friday,

excluding legal holidays.
Federal Register / Vol. 61, No. 90 / Wednesday, May 8, 1996 / Proposed Rules 20785

The public record is located in Room

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 an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this proposal,

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.

Under Executive Order 12866 (58 FR

51735, October 4, 1993), the Agency

must determine whether the regulatory

action is ‘‘significant’’ and therefore

subject to all the requirements of the

Executive Order (i.e., Regulatory Impact

Analysis, review by the Office of

Management and Budget (OMB)). Under

section 3(f), the order defines

‘‘significant’’ as those actions likely to

lead to a rule (1) having an annual effect

on the economy of $100 million or

more, or adversely and materially

affecting a sector of the economy,

productivity, competition, jobs, the

environment, public health or safety, or

State, local or tribal governments or

communities (also known as

‘‘economically significant’’); (2) creating

serious inconsistency or otherwise

interfering with an action taken or

planned by another agency; (3)

materially altering the budgetary

impacts of entitlement, grants, user fees,

or loan programs; or (4) raising novel

legal or policy issues arising out of legal

mandates, the President’s priorities, or

the principles set forth in this Executive

Order.

Pursuant to the terms of this

Executive Order, EPA has determined

that this rule is not ‘‘significant’’ and is

therefore not subject to OMB review.

In addition, this action does not

impose any enforceable duty, or contain

any ‘‘unfunded mandates’’ as described

in Title II of the Unfunded Mandates

Reform Act of 1995 (Pub. L. 104–4), or

require prior consultation as specified

by Executive Order 12875 (58 FR 58093,

October 28, 1993), entitled Enhancing

the Intergovernmental Partnership, or

special consideration as required by

Executive Order 12898 (59 FR 7629,

February 16, 1994).

Pursuant to the requirements of the

Regulatory Flexibility Act (Pub. L. 96–

354, 94 Stat. 1164, 5 U.S.C. 601–612),

the Administrator has determined that

regulations establishing new tolerances

or raising tolerance levels or

establishing exemptions from tolerance

requirements, or establishing or raising

food additive regulations do not have a

significant economic impact on a

substantial number of small entities. A

certification statement to this effect was

published in the Federal Register of

May 4, 1981 (46 FR 24950).

List of Subjects in 40 CFR Parts 180 and

186

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Animal feed,

Food additive, Pesticides and pests,

Reporting and recordkeeping

requirements.

Dated: April 30, 1996.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, it is proposed that chapter

I of title 40 be amended as follows:

PART 180—[AMENDED]

1. In part 180:

a. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 346a and 371.

b. In § 180.145, by adding a

commodity to paragraph (a) in the table

therein and deleting paragraph (c) to

read as follows:

§ 180.145 Fluoride compounds; tolerances

for residues.

(a) * * *

Commodity Parts per million

* * * * *

Potatoes 2.0

* * * * *

* * * * *

PART 186—[AMENDED]

2. In part 186:

a. The authority citation for part 186

continues to read as follows:

Authority: 21 U.S.C. 348.

b. Section 186.3375 is revised to read

as follows:

§ 186.3375 Fluorine compounds.

A tolerance is established for residues

of the insecticidal fluorine compounds

cryolite and synthetic cryolite (sodium

aluminum fluoride) in the following

ready-to-eat animal feed resulting from

application of the compounds to

growing crops:

Commodity Parts per million

Potatoes, waste from

processing

22.0

[FR Doc. 96–11341 Filed 5–7–96; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 300

[FRL–5500–3]

National Oil and Hazardous

Substances Pollution Contingency

Plan; National Priorities List

AGENCY: Environmental Protection

Agency.

ACTION: Notice of Intent to Delete the

Carter Lee Lumber Company Superfund

Site National From Priorities List;

Request for Comments.

SUMMARY: The United States

Environmental Protection Agency (U.S.

EPA) Region V announces its intent to

delete the Carter Lee Lumber Company

Superfund Site from the National

Priorities List (NPL) and requests public

comment on this action. The NPL

constitutes Appendix B to the National

Oil and Hazardous Substances Pollution

Contingency Plan (NCP), which U.S.

EPA promulgated pursuant to Section

105 of the Comprehensive

Environmental Response,

Compensation, and Liability Act of 1980

(CERCLA) as amended. This action is

being taken by U.S. EPA, because it has

been determined that all Fund-financed

responses under CERCLA have been

implemented and U.S. EPA, in

consultation with the State of Indiana,

has determined that no further response

is appropriate. Moreover, U.S. EPA and

the State have determined that remedial

activities conducted at the Site to date

have been protective of public health,

welfare, and the environment.

DATES: Comments concerning the

proposed deletion of the Site from the

NPL may be submitted on or before June

7, 1996.

ADDRESSES: Comments may be mailed to

Helen Smith (SR–6J) Environmental

Protection Assistant, Superfund

Division, U.S. EPA, Region V, 77 W.

Jackson Blvd., Chicago, IL 60604.