20968 Federal Register / Vol. 65, No. 76 / Wednesday, April 19, 2000 / Notices

TABLE 1.—REGISTRATIONS WITH REQUESTED AMENDMENTS—Continued

Company Reg. No. Product SLNs

10163–95 85% Technical ......................

10163–138 35% Wettable Powder

10163–139 35% Wettable Powder ......................

10163–180 50% PVA (Water Soluble Bags) ......................

Micro-Flo Corporation ......................................... 51036–76 22.2% Emulsifiable Concentrate ......................

51036–130 35% Wettable Powder ......................

51036–164 50% Water Dispensable Granules AZ99000500

Platte Chemical Company .................................. 34704–691 22.2% Emulsifiable Concentrate ......................

TABLE 2.—REGISTRATIONS WITH CANCELLATION REQUESTS

Company Reg. No. Product SLNs

Micro-Flo Corporation ......................................... a51036–76 22.2% Emulsifiable Concentrate TX89001100

51036–205 50% Wettable Powder ......................

51036–207 22.2% Emulsifiable Concentrate ......................

a Note that EPA Reg. No. 51036–76 is not being canceled; rather SLN TX89001100 is being canceled.

B. What is the Agency’s Authority for

Taking this Action?

In the December 3, 1999, FR Notice,

EPA requested public comment on the

voluntary cancellation and use deletion

requests, and provided a 30-day

comment period. The registrants

requested that the Administrator waive

the 180-day period provided under

FIFRA section 6(f)(1)(C). No public

comments were submitted to the docket

in response to EPA’s request for

comments.

III. Cancellation Order

Pursuant to section 6(f) of FIFRA, EPA

is approving the requested use deletions

and the requested registration

cancellations. Accordingly, the Agency

orders that the registrations identified in

Table 1 above are hereby amended to

delete use on cotton in Louisiana and

east of the Mississippi River, and on

sugarcane, ornamentals (except for

nursery stocks), Christmas trees, shade

trees, and forest trees. The Agency also

orders that the registrations identified in

Table 2 are hereby canceled. Any

distribution, sale, or use of existing

stocks of the products identified in

Tables 1 and 2 above in a manner

inconsistent with the terms of this Order

or the Existing Stock Provisions in Unit

IV of this Federal Register Notice will

be considered a violation of section

12(a)(2)(K) of FIFRA and/or section

12(a)(1)(A) of FIFRA.

IV. Existing Stocks Provisions

For purposes of this Order, the term

‘‘existing stocks’’ is defined, pursuant to

EPA’s existing stocks policy (56 FR

29362, June 26, 1991), as those stocks of

a registered pesticide product which are

currently in the United States and

which have been packaged, labeled, and

released for shipment prior to the

effective date of the amendment or

cancellation.

A. Distribution or Sale by Registrants

Unless existing stocks of products

identified in Table 1 above have been

relabeled in a manner consistent with

the Agreement, the distribution or sale

of such stocks by registrants is not

lawful under FIFRA after April 19,

2000, except for the purposes of returns

and relabeling, shipping such stocks for

export consistent with the requirements

of section 17 of FIFRA, or for proper

disposal. The distribution or sale of

existing stocks of products identified in

Table 2 above by registrants is not

lawful under FIFRA after April 19,

2000, except for the purposes of

shipping such stocks for export

consistent with the requirements of

section 17 of FIFRA or for proper

disposal.

B. Distribution or Sale by Other Persons

Unless existing stocks of products

identified in Table 1 above have been

relabeled in a manner consistent with

the Agreement, the distribution or sale

of such stocks by persons other than

registrants is not lawful under FIFRA

after April 19, 2000, except for the

purposes of returns and relabeling,

shipping such stocks for export

consistent with the requirements of

section 17 of FIFRA, or for proper

disposal. The distribution or sale of

existing stocks of products identified in

Table 2 by persons other than registrants

is not lawful under FIFRA after April

19, 2000, except for the purposes of

shipping such stocks for export

consistent with the requirements of

section 17 of FIFRA or for proper

disposal.

C. Use of Existing Stocks

The use of existing stocks of products

identified in Tables 1 and 2 above on

cotton in Louisiana and east of the

Mississippi River, and on sugarcane,

ornamentals (except nursery stock),

Christmas trees, shade trees, and forest

trees will be lawful under FIFRA until

such stocks are depleted provided that

the use is in accordance with either the

directions for use contained in the

Agreement or the existing labeling of

that product.

List of Subjects

Environmental protection, pesticides

and pests.

Dated: April 10, 2000.

Lois A. Rossi,

Director, Special Review and Reregistration

Division, Office of Pesticide Programs.

[FR Doc. 00–9798 Filed 4–18–00; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[PF–923; FRL–6495–7]

Notice of Filing a Pesticide Petition to

Establish a Tolerance for a Certain

Pesticide Chemical in or on Food

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

initial filing of a pesticide petition

proposing the establishment of

regulations for residues of a certain

Federal Register / Vol. 65, No. 76 / Wednesday, April 19, 2000 / Notices 20969

pesticide chemicals in or on various

food commodities.

DATES: Comments, identified by docket

control number PF–923, must be

received on or before May 19, 2000.

ADDRESSES: Comments may be

submitted by mail, electronically, or in

person. Please follow the detailed

instructions for each method as

provided in Unit I.C. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, it is imperative

that you identify docket control number

PF–923 in the subject line on the first

page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Marshall Swindell, PM 33

Regulatory Management Branch I,

Antimicrobials Division (7510C), Office

of Pesticide Programs, Environmental

Protection Agency, Ariel Rios Bldg.,

1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 308–6341; e-mail address:

swindell.marshall@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer or pesticide manufacturer.

Potentially affected categories and

entities may include, but are not limited

to:

CategoriesNAICS

codes

Examples of potentially affected entities

Industry 111 Crop production.

112 Animal production.

311 Food manufacturing.

32532 Pesticide manufacturing.

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations’’ and then look

up the entry for this document under

the ‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/.

2. In person. The Agency has

established an official record for this

action under docket control number PF–

923. The official record consists of the

documents specifically referenced in

this action, any public comments

received during an applicable comment

period, and other information related to

this action, including any information

claimed as confidential business

information (CBI). This official record

includes the documents that are

physically located in the docket, as well

as the documents that are referenced in

those documents. The public version of

the official record does not include any

information claimed as CBI. The public

version of the official record, which

includes printed, paper versions of any

electronic comments submitted during

an applicable comment period, is

available for inspection in the Public

Information and Records Integrity

Branch (PIRIB), Rm. 119, Crystal Mall

#2, 1921 Jefferson Davis Highway,

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

Monday through Friday, excluding legal

holidays. The PIRIB telephone number

is (703) 305–5805.

C. How and to Whom Do I Submit

Comments?

You may submit comments through

the mail, in person, or electronically. To

ensure proper receipt by EPA, it is

imperative that you identify docket

control number PF–923 in the subject

line on the first page of your response.

1. By mail. Submit your comments to:

Public Information and Records

Integrity Branch (PIRIB), Information

Resources and Services Division

(7502C), Office of Pesticide Programs

(OPP), Environmental Protection

Agency, Ariel Rios Bldg., 1200

Pennsylvania Ave., NW., Washington,

DC 20460.

2. In person or by courier. Deliver

your comments to: Public Information

and Records Integrity Branch (PIRIB),

Information Resources and Services

Division (7502C), Office of Pesticide

Programs (OPP), Environmental

Protection Agency, Rm. 119, Crystal

Mall #2, 1921 Jefferson Davis Highway,

Arlington, VA. The PIRIB is open from

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

Friday, excluding legal holidays. The

PIRIB telephone number is (703) 305–

5805.

3. Electronically. You may submit

your comments electronically by e-mail

to: ‘‘opp-docket@epa.gov,’’ or you can

submit a computer disk as described

above. Do not submit any information

electronically that you consider to be

CBI. Avoid the use of special characters

and any form of encryption. Electronic

submissions will be accepted in

Wordperfect 6.1/8.0 or ASCII file

format. All comments in electronic form

must be identified by docket control

number PF–923. Electronic comments

may also be filed online at many Federal

Depository Libraries.

D. How Should I Handle CBI That I

Want to Submit to the Agency?

Do not submit any information

electronically that you consider to be

CBI. You may claim information that

you submit to EPA in response to this

document as CBI by marking any part or

all of that information as CBI.

Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

In addition to one complete version of

the comment that includes any

information claimed as CBI, a copy of

the comment that does not contain the

information claimed as CBI must be

submitted for inclusion in the public

version of the official record.

Information not marked confidential

will be included in the public version

of the official record without prior

notice. If you have any questions about

CBI or the procedures for claiming CBI,

please consult the person identified

under FOR FURTHER INFORMATION

CONTACT.

E. What Should I Consider as I Prepare

My Comments for EPA?

You may find the following

suggestions helpful for preparing your

comments:

1. Explain your views as clearly as

possible.

2. Describe any assumptions that you

used.

3. Provide copies of any technical

information and/or data you used that

support your views.

4. If you estimate potential burden or

costs, explain how you arrived at the

estimate that you provide.

5. Provide specific examples to

illustrate your concerns.

6. Make sure to submit your

comments by the deadline in this

notice.

7. To ensure proper receipt by EPA,

be sure to identify the docket control

number assigned to this action in the

subject line on the first page of your

20970 Federal Register / Vol. 65, No. 76 / Wednesday, April 19, 2000 / Notices

response. You may also provide the

name, date, and Federal Register

citation.

II. What Action is the Agency Taking?

EPA has received a pesticide petition

as follows proposing the establishment

and/or amendment of regulations for

residues of a certain pesticide chemical

in or on various food commodities

under section 408 of the Federal Food,

Drug, and Comestic Act (FFDCA), 21

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

this petition contains data or

information regarding the elements set

forth in section 408(d)(2); however, EPA

has not fully evaluated the sufficiency

of the submitted data at this time or

whether the data supports granting of

the petition. Additional data may be

needed before EPA rules on the petition.

List of Subjects

Environmental protection,

Agricultural commodities, Feed

additives, Food additives, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: May 11, 2000.

Frank Sanders,

Director, Antimicrobials Division, Office of

Pesticide Programs.

Summary of Petition

The petitioner summary of the

pesticide petition is printed below as

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

FFDCA. The summary of the petition

was prepared by the petitioner and

represents the view of the petitioners.

EPA is publishing the petition summary

verbatim without editing it in any way.

The petition summary announces the

availability of a description of the

analytical methods available to EPA for

the detection and measurement of the

pesticide chemical residues or an

explanation of why no such method is

needed.

Milliken Chemical

8F5007

EPA has received a supplement to a

pesticide petition (8F5007) from

Milliken Chemical, P.O. Box 1927,

Spartanburg, SC 29304–1927,

proposing, pursuant to section 408(d) of

the Federal Food, Drug, and Cosmetic

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

amend 40 CFR part 180 to establish an

exemption from the requirement of a

tolerance for silver sodium hydrogen

zirconium phosphate, when used as an

antimicrobial agent at levels up to 2%

by weight, in or on polymers used for

food-contact surfaces, for the following

applications: containers, tubing,

utensils, hardware, filters, appliances,

food preparation, or processing surfaces,

food storage devices, coverings, film,

packaging (other than food packaging

regulated exclusively by the Food, and

Drug Administration (FDA)), fabrics,

equipment, conveyance, and transport

items, and tools. EPA has determined

that the petition contains data or

information regarding the elements set

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

however, EPA has not fully evaluated

the sufficiency of the submitted data at

this time, or whether the data supports

granting of the petition. Additional data

may be needed before EPA rules on the

petition.

A. Residue Chemistry

1. Plant metabolism. Silver sodium

hydrogen zirconium phosphate will not

be used on growing plants. Plant

metabolism studies are therefore not

necessary.

2. Analytical method. Silver sodium

hydrogen zirconium phosphate and its

potential migration products, silver and

zirconium, have been determined to be

at such low levels that there is no need

for an established method for

quantitating levels of such residues in or

on food.

3. Magnitude of residues. The

proposed use of silver sodium hydrogen

zirconium phosphate is at levels up to

2% by weight in or on substances such

as polymers. Migration studies estimate

the maximum amounts of silver and

zirconium that might migrate from a

polymer impregnated with silver

sodium hydrogen zirconium phosphate

are less than the limits of detection (i.e.,

10 parts per billion (ppb) for silver, and

20 ppb for zirconium). The levels of

anticipated residues of silver and

zirconium that might migrate from

contact substances into or onto food are

expected to be negligible.

B. Toxicological Profile

1. Acute toxicity. The acute toxicity

data for silver sodium hydrogen

zirconium phosphate are the following:

(i) The acute median lethal oral dose in

rats is greater than 5 g/kg body weight

(Toxicity Category IV); (ii) the acute

median lethal dermal dose in rats is

greater than 2 g/kg body weight

(Toxicity Category III); (3) the acute

inhalation median lethal concentration

is greater than 5.18 milligram liter (mg/

L) in rats with nose only exposure

(Toxicity Category IV); (iv) eye irritation

and opacity is reversible within 72

hours in rabbits (Toxicity Category III);

(v) no dermal irritation is induced when

applied at 0.5 g under occlusion to

rabbits (Toxicity Category IV); and (vi)

no evidence of dermal sensitization is

produced in guinea pigs.

2. Genotoxicity. Mutagenicity tests for

silver sodium hydrogen zirconium

phosphate are negative in the Ames

Salmonella typhimurium, and

Escherichia coli (wp2 uvrA) assays with

and without activation, and are negative

in the forward mutation mouse

lymphoma assay with and without

activation. Silver sodium hydrogen

zirconium phosphate shows no

evidence for chromosome-damaging

activity in the mouse micronucleus test.

3. Reproductive and developmental

toxicity. Doses up to 1,000 milligrams/

kilograms/day (mg/kg/day) of silver

sodium hydrogen zirconium phosphate

showed no evidence for maternal

toxicity and no statistically significant

test material-related effects on the

growth and development of offspring.

Visceral and skeletal anomalies were

proportional in fetuses from control and

treated rats. The maternal (systemic) no

observed adverse effect level (NOAEL)

was 1,000 mg/kg/day, and the

developmental (fetal) NOAEL was 1,000

mg/kg/day.

4. Subchronic toxicity—i. Palatability

study. Doses up to 1,000 mg/kg/day of

silver sodium hydrogen zirconium

phosphate in the diet of male and

female rats for 14 days caused no

deaths, no abnormal clinical signs, no

effects on body weights, and no

palatability problems.

ii. Ninety-day oral toxicity. Male and

female rats were administered silver

sodium hydrogen zirconium phosphate

in the diet for 13 weeks at

concentrations up to 1,000 mg/kg/day.

Increases in cholesterol in males and in

alkaline phosphatase in females were

observed but were not biologically

significant. The NOAEL was 1,000 mg/

kg/day, and the NOAEL was 30 mg/kg/

day.

5. Chronic toxicity. No chronic

exposure to silver sodium hydrogen

zirconium phosphate is expected,

therefore, no chronic toxicity studies are

needed. Five chronic toxicity studies

failed to show effects when silver was

administered in the drinking water of

rats.

6. Carcinogenicity. No chemical

carcinogenicity is expected from silver

sodium hydrogen zirconium phosphate.

This is based on the absence of

significant adverse toxicological effects

in the subchronic study, and negative

genotoxicity data. Negligible exposure

to migrant silver is expected from the

proposed uses of silver sodium

hydrogen zirconium, based on migration

studies. The levels of silver found in the

normal human diet are greater than

could potentially arise from migration.

EPA classifies silver as a Group D

carcinogen.

Federal Register / Vol. 65, No. 76 / Wednesday, April 19, 2000 / Notices 20971

7. Metabolite toxicology. The

principal migration products from silver

sodium hydrogen zirconium phosphate

are silver and zirconium. Silver has an

EPA reference dose (RfD) of 0.005 mg/

kg/day and does not occur normally in

animal or human tissues. The major

effect of excessive absorption of silver is

local or generalized impregnation of the

tissue with silver, a condition called

argyria. Argyria is not associated with

any adverse health effects. Silver is

absorbed from the lungs and in small

amounts from the gastrointestinal (GI)

tract, and form complexes with

albumin. The GI tract is the major route

of excretion of silver (90 to 99% in 2

days).

Zirconium is extensive in the human

diet with the daily uptake up to 125 mg.

The toxicity level for this ubiquitous

element is negligible. Zirconium is

present and retained in high quantities

in biological systems, but has not been

associated with any specific metabolic

function. The average body burden is

250 mg.

8. Endocrine disruption. Silver

sodium hydrogen zirconium phosphate,

silver, and zirconium are not chemically

or structurally similar to natural

hormones, and are not expected to

disrupt, block, enhance, mimic, or

otherwise interfere with normal

endocrine system functions.

C. Aggregate Exposure

1. Dietary exposure. Based on the

toxicity data, an aggregate risk, or

likelihood of the occurrence of an

adverse health effect resulting from all

routes of exposure to silver sodium

hydrogen zirconium phosphate is not

anticipated. Used in polymeric food

contact substances, dietary exposures to

migrant silver and zirconium are

estimated in migration studies to be

below 10 ppb for silver, and 20 ppb for

zirconium. These levels are much less

than in a normal human diet. For the

migration studies, silver sodium

hydrogen zirconium phosphate was

embedded in a polymer, and migrant

silver and zirconium were extracted into

ethanol for quantitation by atomic

absorption (silver) and UV/VIS

absorption (zirconium). The Estimated

Dietary Intakes (EDIs) that might be

expected to enter the diet as a result of

the proposed use of the silver sodium

hydrogen zirconium phosphate were 12

μg/day (silver), and 24 μg/day

(zirconium). These levels are not

expected to induce toxicity.

i. Food. Silver sodium hydrogen

zirconium phosphate will be

incorporated into polymeric food

contact substances, will not be

introduced intentionally into food, and

is not expected to induce acute or

chronic toxicological concerns. The

calculated RfD for silver sodium

hydrogen zirconium phosphate is 0.003

mg/kg/day and is based on the

subchronic toxicity (NOAEL=30 mg/kg/

day) and accepted uncertainty factors

that account for extrapolation from the

subchronic NOAEL, extrapolation from

animals to humans, variation among the

human population, and a worst case

modifying factor. EPA RfD for silver is

0.005 mg/kg/day.

ii. Drinking water. Silver sodium

hydrogen zirconium phosphate will be

incorporated into polymeric food

contact substances and will not be

introduced intentionally into the

environment or the drinking water. If a

drinking water exposure of 1 mg were

assumed, the lifetime daily exposure

level would be 1.0 × 10¥6 mg/kg/day

and would not cause toxic responses.

2. Non-dietary exposure. The

proposed uses of silver sodium

hydrogen zirconium phosphate are not

expected to result in any significant

non-dietary exposure for the general

population.

D. Cumulative Effects

The cumulative exposure assessment

provides an estimate of the extent to

which a defined population is exposed

to two or more chemicals which share

a common mechanism of toxicity by all

relevant routes and from all relevant

sources. There are no data to suggest

that silver or zirconium are synergistic

or antagonistic of each other, or of silver

sodium hydrogen zirconium phosphate.

E. Safety Determination

1. U.S. population. The toxicology

data provided to establish an exemption

from the requirement of a tolerance for

silver sodium hydrogen zirconium

phosphate demonstrate that this

substance is of a very low order of

toxicity. The EDIs for the silver and

zirconium migrants from the pesticide

chemical are 12 μg/day (4 ppb) for

silver, and 24 μg/day (8 ppb) for

zirconium. These exposure levels are

not significant health or safety concerns.

The RfD for silver sodium hydrogen

zirconium phosphate is 0.003 mg/kg/

day and is comparable to the RfD of

0.005 mg/kg/day for silver. For

zirconium, neither an RfD nor an ADI

have been established due to the

absence of toxicological concern for this

ubiquitous element. Zirconium is

present at high levels in foods; the

average daily intake is estimated to be

4.2 mg/kg/day. This level far exceeds

the maximum contribution of zirconium

anticipated from silver sodium

hydrogen zirconium phosphate in

polymeric food-contact materials.

For drinking water, EPA has

established a Secondary Maximum

Contaminant Level (SMCL) for silver of

0.1 mg/L, and the FDA bottled drinking

water standard is 50 μg/L. These

standards far exceed the anticipated

drinking water exposure levels of 0.039

μg/kg calculated for silver sodium

hydrogen zirconium phosphate.

2. Infants and children. The potential

for additional sensitivity of infants and

children was assessed from a

developmental toxicity study in rats.

Doses up to 1,000 mg/kg/day elicited no

maternal toxicity and no significant

effects on the growth and development

of offspring (fetal NOAEL = 1,000 mg/

kg/day).

Based on migration data with silver

sodium hydrogen zirconium phosphate,

consumption patterns of infants and

children (i.e., a 10 kg child consumes 1

kg of food), and the assumption that

80% of the diet comes into contact with

polymeric packaging material

containing the pesticide chemical, the

expected dietary exposure to silver and

zirconium are calculated as:

Silver: 0.80 × 5 ppb = 4 ppb (4 ppb of 1,000

g daily diet = 4 μg/person/day).

Zirconium: 0.80 × 10 ppb = 8 ppb (8 ppb

of 1,000 g daily diet = 8 μg/person/day).

These exposure levels are not

expected to cause toxicological

responses.

There is no evidence that infants and

children would: (1) consume

disproportionately high levels of food

containing residues of sodium hydrogen

zirconium phosphate, silver or

zirconium; (2) be more susceptible to

silver sodium hydrogen zirconium

phosphate, silver or zirconium; (3) be

susceptible to growth and development

defects or neurological effects induced

by silver sodium hydrogen zirconium

phosphate; or (4) experience harm from

cumulative or aggregate exposures to

silver sodium hydrogen zirconium

phosphate or to silver and zirconium.

F. International Tolerances

There are no international tolerances

for silver sodium hydrogen zirconium

phosphate. There are no U.S. EPA,

CODEX (international), Canadian or

Mexican tolerances for silver.

[FR Doc. 00–9665 Filed 4–18–00; 8:45 am]

BILLING CODE 6560–50–F