Federal Register / Vol. 62, No. 38 / Wednesday, February 26, 1997 / Notices 8731

III. Procedures for Withdrawal of

Request

Registrants who choose to withdraw a

request for cancellation must submit

such withdrawal in writing to James A.

Hollins, at the address given above,

postmarked before August 25, 1997.

This written withdrawal of the request

for cancellation will apply only to the

applicable 6(f)(1) request listed in this

notice. If the product(s) have been

subject to a previous cancellation

action, the effective date of cancellation

and all other provisions of any earlier

cancellation action are controlling. The

withdrawal request must also include a

commitment to pay any reregistration

fees due, and to fulfill any applicable

unsatisfied data requirements.

IV. Provisions for Disposition of

Existing Stocks

The effective date of cancellation will

be the date of the cancellation order.

The orders effecting these requested

cancellations will generally permit a

registrant to sell or distribute existing

stocks for 1 year after the date the

cancellation request was received. This

policy is in accordance with the

Agency’s statement of policy as

prescribed in Federal Register (56 FR

29362) June 26, 1991; [FRL 3846–4].

Exceptions to this general rule will be

made if a product poses a risk concern,

or is in noncompliance with

reregistration requirements, or is subject

to a data call-in. In all cases, productspecific disposition dates will be given

in the cancellation orders.

Existing stocks are those stocks of

registered pesticide products which are

currently in the United States and

which have been packaged, labeled, and

released for shipment prior to the

effective date of the cancellation action.

Unless the provisions of an earlier order

apply, existing stocks already in the

hands of dealers or users can be

distributed, sold or used legally until

they are exhausted, provided that such

further sale and use comply with the

EPA-approved label and labeling of the

affected product(s). Exceptions to these

general rules will be made in specific

cases when more stringent restrictions

on sale, distribution, or use of the

products or their ingredients have

already been imposed, as in Special

Review actions, or where the Agency

has identified significant potential risk

concerns associated with a particular

chemical.

List of Subjects

Environmental protection, Pesticides

and pests, Product registrations.

Dated: February 11, 1997.

Linda A. Travers,

Director, Program Management and Support

Division, Office of Pesticide Programs.

[FR Doc. 97–4775 Filed 2–25–97; 8:45 am]

BILLING CODE 6560–50–F

[PF–713; FRL–5589–2]

Bayer Corporation; Pesticide

Tolerance Petition Filing

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

filing of a pesticide petition proposing

the establishment of a regulation for

residues of imidacloprid in or on cereal

grain, sweet corn, safflower and

soybeans. The notice contains a

summary of the petition prepared by the

petitioner, Bayer Corporation.

DATES: Comments, identified by the

docket number [PF–713], must be

received on or before March 28, 1997.

ADDRESSES: By mail, submit written

comments to: Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

comments to: Rm. 1132 CM #2, 1921

Jefferson Davis Highway, Arlington, VA

22202. Comments and data may also be

submitted electronically by sending

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

comments must be submitted 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 5.1

file format or ASCII file format. All

comments and data in electronic form

must be identified by the docket number

[PF–713]. Electronic comments on this

notice may be filed online at many

Federal Depository Libraries. Additional

information on electronic submissions

can be found in Unit II of this

document.

Information submitted as comments

concerning this notice 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: Dennis H. Edwards, Jr., Product

Manager (PM) 19, Registration Division

(7505C), Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460. Office location, telephone

number and e-mail address: Rm. 207,

CM #2, 1921 Jefferson Davis Hwy.,

Arlington, VA 22202, (703)–305–6386;

e-mail:

edwards.dennis@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA has

received a pesticide petition (PP)

6F4765 pursuant to section 408(d) of the

Federal Food, Drug and Cosmetic Act,

as amended, 21 U.S.C. 346a(d), by the

Food Quality Protection Act of 1996

(FQPA) (Pub. L. 104–170, 110 Stat.

1489) from Bayer Corporation (‘‘Bayer’’),

8400 Hawthorn Rd., P.O. Box 4913,

Kansas City, MO 64120–0013 proposing

to amend 40 CFR 180.472 by

establishing tolerances for inadvertent

or indirect residues of the insecticide,

imidacloprid: 1-[(6-chloro-3-

pyridinyl)methyl]-N-nitro-2-

imidazolidinimine and its metabolites

containing the 6-chloro-pyridinyl

moiety in or on cereal grain [grain 0.05

parts per million (ppm), forage (2.0

ppm), stover (0.3 ppm), hay (6.0 ppm),

and straw (3.0 ppm)], sweet corn (0.05

ppm), legume vegetables (0.3 ppm) [and

foliage thereof (2.5 ppm)], and safflower

seed (0.05 ppm). The nature of the

imidacloprid residue in plants and

livestock is adequately understood. The

analytical method for determining

residues is a common moiety method

for imidacloprid and its metabolites

containing the 6-chloro-pyridinyl

moiety using oxidation, derivatization,

and analysis by capillary gas

chromatography with a mass-selective

detector. These tolerances would allow

for a 1–month plant back interval for

these crops following normal

application of imidacloprid-containing

products.

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

FQPA, Bayer Corporation included in
8732 Federal Register / Vol. 62, No. 38 / Wednesday, February 26, 1997 / Notices

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 Bayer

Corporation; 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 the purpose of

clarity.

I. Petition Summary

Imidacloprid is a broad-spectrum

insecticide with excellent systemic and

contact toxicity characteristics which is

used primarily for sucking insects.

A. Plant Metabolism and Analytical

Method

The metabolism of imidacloprid in

plants is adequately understood for the

purposes of these tolerances. The

residues of concern are combined

residues of imidacloprid and its

metabolites containing the 6-chloropyridinyl moiety, all calculated as

imidacloprid. The analytical method is

a common moiety method for

imidacloprid and its metabolites

containing the 6-chloropyridinyl moiety

using a permanganate oxidation, silyl

derivatization, and capillary GC-MS

selective ion monitoring. This method

has successfully passed a petition

method validation in EPA labs. There is

a confirmatory method specifically for

imidacloprid and several metabolites

utilizing GC/MS and HPLC-UV which

has been validated by the EPA as well.

Imidacloprid and its metabolites are

stable for at least 24 months in the

commodities when frozen.

B. Magnitude of the Residue

Field rotational crop studies were

conducted in three states where soil was

treated with imidacloprid at a rate of 0.3

lbs active ingredient per acre (ai/A) (1x).

After 30 days, rotational crops were

planted, grown to maturity, and

harvested at appropriate times. Residue

levels in cereal grain, sweet corn

(K+CWHR), and safflower seed were

<0.05 ppm. Maximum residues were

1.81 ppm in cereal grain forage, 0.26

ppm in cereal grain stover, 2.7 ppm in

cereal grain straw, 0.22 ppm in legume

vegetables, and 2.33 ppm in legume

vegetable foliage. These residue data

support tolerances of 0.05 ppm for

cereal grain, sweet corn (K+CWHR), and

safflower seed; 2.0 ppm for cereal grain

forage; 0.3 ppm for cereal grain stover;

6.0 ppm for cereal grain hay; 3.0 ppm

in cereal grain straw; 0.3 ppm in legume

vegetables; and 2.5 ppm for the foliage

of legume vegetables. No processing

studies were submitted with this

petition, however, available data would

indicate that tolerances on corn meal

(0.05 ppm), soybean meal (0.5 ppm) and

a time-limited tolerance on safflower

meal (0.5 ppm) could be considered.

The registrant has committed to provide

data to support these processed

commodities. CBTS has concluded that

existing poultry meat and egg tolerances

are adequate to support the proposed

new uses of imidacloprid.

C. Toxicological Profile of Imidacloprid

1. Acute toxicity. The acute oral LD50

values for imidacloprid technical ranged

from 424 to 475 milligrams per kilogram

of body weight (mg/kg bwt) in the rat.

The acute dermal LD50 was greater than

5,000 milligrams per kilogram (mg/kg)

in rats. The 4–hour rat inhalation LC50

was >69 milligrams per cubic meter

(mg/m3) air (aerosol). Imidacloprid was

not irritating to rabbit skin or eyes.

Imidacloprid did not cause skin

sensitization in guinea pigs.

2. Genotoxicity. Extensive

mutagenicity studies conducted to

investigate point and gene mutations,

DNA damage and chromosomal

aberration, both using in vitro and in

vivo test systems show imidacloprid to

be non-genotoxic.

3. Reproductive and developmental

toxicity. A two-generation rat

reproduction study gave a no-observedeffect level (NOEL) of 100 ppm (8 mg/

kg/bwt). Rat and rabbit developmental

toxicity studies were negative at doses

up to 30 mg/kg/bwt and 24 mg/kg/bwt,

respectively.

4. Subchronic toxicity. Ninety-day

(90–day) feeding studies were

conducted in rats and dogs. The NOEL’s

for these tests were 14 mg/kg bwt/day

(150 ppm) and 5 mg/kg bwt/day (200

ppm) for the rat and dog studies

respectively.

5. Chronic toxicity/oncogenicity. A 2–

year rat feeding/carcinogenicity study

was negative for carcinogenic effects

under the conditions of the study and

had a NOEL of 100 ppm (5.7 mg/kg/bwt

in male and 7.6 mg/kg/bwt female) for

noncarcinogenic effects that included

decreased body weight gain in females

at 300 ppm and increased thyroid

lesions in males at 300 ppm and females

at 900 ppm. A 1–year dog feeding study

indicated a NOEL of 1,250 ppm (41 mg/

kg/bwt). A 2–year mouse

carcinogenicity study that was negative

for carcinogenic effects under

conditions of the study and that had a

NOEL of 1,000 ppm (208 mg/kg/day).

Imidacloprid has been classified

under ‘‘Group E’’ (no evidence of

carcinogenicity) by EPA’s OPP/HED’s

Reference Dose (RfD) Committee. There

is no cancer risk associated with

exposure to this chemical. The reference

dose (RfD) based on the 2–year rat

feeding/carcinogenic study with a NOEL

of 5.7 mg/kg/bwt and 100–fold

uncertainty factor, is calculated to be

0.057 mg/kg/bwt. The theoretical

maximum residue contribution (TMRC)

from published uses is 0.008358 mg/kg/

bwt/day utilizing 14.7% of the RfD.

6. Endocrine effects. The toxicology

database for imidacloprid is current and

complete. Studies in this database

include evaluation of the potential

effects on reproduction and

development, and an evaluation of the

pathology of the endocrine organs

following short- or long-term exposure.

These studies revealed no primary

endocrine effects due to imidacloprid.

7. Mode of action. Imidacloprid

exhibits a mode of action different from

traditional organophosphate, carbamate,

or pyrethroid insecticides. Imidacloprid

acts by binding to the nicotinergic

receptor sites at the postsynaptic

membrane of the insect nerve. Due to

this novel mode of action, imidacloprid

has not shown any cross resistance to

registered alternative insecticides and is

a valuable tool for use in IPM or

resistance management programs.

D. Aggregate Exposure

Imidacloprid is a broad-spectrum

insecticide with excellent systemic and

contact toxicity characteristics with

both food and non-food uses.

Imidacloprid is currently registered for

use on various food crops, tobacco, turf,

ornamentals, buildings for termite

control, and cats and dogs for flea

control. Those potential exposures are

addressed below:

1. Dietary. The EPA has determined

that the reference dose (RfD) based on

the 2–year rat feeding/carcinogenic

study with a NOEL of 5.7 mg/kg/bwt

and 100–fold uncertainty factor, is

calculated to be 0.057 mg/kg/bwt. As

published in the Federal Register of

December 13, 1995 (60 FR 64006)(FRL–

4990–5) and June 12, 1996 Federal

Register (61 FR 2674)(FRL–5367–8)

(petition to establish tolerances on leafy

green vegetables (PP 5F4522/R2237)),

the TMRC from published uses is

0.008358 mg/kg/bwt/day utilizing

14.7% of the RfD for the general

population. For the most highly exposed

subgroup in the population, nonnursing infants (< 1 year old), the TMRC

for the published tolerances is 0.01547

mg/kg/day. This is equal to 27.1% of the

RfD. Therefore, Bayer believes that

dietary exposure from the existing uses

including the currently proposed

inadvertent or indirect residue

tolerances will not exceed the RfD for
Federal Register / Vol. 62, No. 38 / Wednesday, February 26, 1997 / Notices 8733

any subpopulation (including infants

and children).

2. Water. Although the various

imidacloprid labels contain a statement

that this chemical demonstrates the

properties associated with chemicals

detected in groundwater, Bayer is not

aware of imidacloprid being detected in

any wells, ponds, lakes, streams, etc.

from its use in the United States. In

studies conducted in 1995, imidacloprid

was not detected in 17 wells on potato

farms in Quebec, Canada. In addition,

groundwater monitoring studies are

currently underway in California and

Michigan. Therefore, Bayer believes that

contributions to the dietary burden from

residues of imidacloprid in water would

be inconsequential.

3. Non-occupational— a. Residential

turf. Bayer has conducted an exposure

study to address the potential exposures

of adults and children from contact with

imidacloprid treated turf. The

population considered to have the

greatest potential exposure from contact

with pesticide treated turf soon after

pesticides are applied are young

children. Margins of safety (MOS) of

7,587 to 41,546 for 10–year–old children

and 6,859 to 45,249 for 5–year–old

children were estimated by comparing

dermal exposure doses to the

imidacloprid no observable effect level

of 1,000 mg/kg/day established in a 15–

day dermal toxicity study in rabbits.

The estimated safe residue levels of

imidacloprid on treated turf for 10–

year–old children ranged from 5.6 to

38.2 g/cm2 and for 5–year–old children

from 5.1 to 33.5 g/cm2. This compares

with the average imidacloprid

transferable residue level of 0.080 g/cm2

present immediately after the sprays

have dried. These data indicate that

children can safely contact

imidacloprid-treated turf as soon after

application as the spray has dried.

b. Termiticide. Imidacloprid is

registered as a termiticide. Due to the

nature of the treatment for termites,

exposure would be limited to that from

inhalation and was evaluated by EPA’s

Occupational and Residential Exposure

Branch’s (OREB) and Bayer. Data

indicate that the Margins of Safety for

the worst case exposures for adults and

infants occupying a treated building

who are exposed continuously (24

hours/day) are 8.0 × 107 and 2.4 × 108,

respectively—and exposure can thus be

considered negligible.

c. Tobacco smoke. Studies have been

conducted to determine residues in

tobacco and the resulting smoke

following treatment. Residues of

imidacloprid in cured tobacco following

treatment were a maximum of 31 ppm

(7 ppm in fresh leaves). When this

tobacco was burned in a pyrolysis study

only 2 percent of the initial residue was

recovered in the resulting smoke (main

stream plus side stream). This would

result in an inhalation exposure to

imidacloprid from smoking of

approximately 0.0005 mg per cigarette.

Using the measured subacute rat

inhalation NOEL of 5.5 mg/m3, it is

apparent that exposure to imidacloprid

from smoking (direct and/or indirect

exposure) would not be significant.

d. Pet treatment. Human exposure

from the use of imidacloprid to treat

dogs and cats for fleas has been

addressed by EPA’s OREB who have

concluded that due to the fact that

imidacloprid is not an inhalation or

dermal toxicant and that while dermal

absorption data are not available,

imidacloprid is not considered to

present a hazard via the dermal route.

4. Cumulative effects. No other

chemicals having the same mechanism

of toxicity are currently registered,

therefore, Bayer believes that there is no

risk from cumulative effects from other

substances with a common mechanism

of toxicity.

E. Safety Determinations

1. U.S. population in general. Using

the conservative exposure assumptions

described above and based on the

completeness and reliability of the

toxicity data, Bayer concludes that total

aggregate exposure to imidacloprid from

all current uses including those

currently proposed will utilize little

more than 15% of the RfD for the U.S.

population. EPA generally has no

concerns for exposures below 100% of

the RfD, because the RfD represents the

level at or below which daily aggregate

exposure over a lifetime will not pose

appreciable risks to human health.

Thus, Bayer concludes that there is a

reasonable certainty that no harm will

result from aggregate exposure to

imidacloprid residues.

2. Infants and children. In assessing

the potential for additional sensitivity of

infants and children to residues of

imidacloprid, the data from

developmental studies in both rat and

rabbit and a two-generation

reproduction study in the rat have been

considered. The developmental toxicity

studies evaluate potential adverse

effects on the developing animal

resulting from pesticide exposure of the

mother during prenatal development .

The reproduction study evaluates effects

from exposure to the pesticide on the

reproductive capability of mating

animals through two generations, as

well as any observed systemic toxicity.

FFDCA section 408 provides that EPA

may apply an additional safety factor for

infants and children in the case of

threshold effects to account for pre- and

post- natal effects and the completeness

of the toxicity database. Based on

current toxicological data requirements,

the toxicology database for imidacloprid

relative to pre- and post-natal effects is

complete. Further for imidacloprid, the

NOEL of 5.7 mg/kg/bwt from the 2–year

rat feeding/carcinogenic study, which

was used to calculate the RfD (discussed

above), is already lower than the NOELs

from the developmental studies in rats

and rabbits by a factor of 4.2 to 17.5

times. Since a 100–fold uncertainty

factor is already used to calculate the

RfD, Bayer surmises that an additional

uncertainty factor is not warranted and

that the RfD at 0.057 mg/kg/bwt/day is

appropriate for assessing aggregate risk

to infants and children.

Using the conservative exposure

assumptions described above, EPA has

concluded that the TMRC from use of

imidacloprid from published uses is

0.008358 mg/kg/bwt/day utilizing

14.7% of the RfD for the general

population. For the most highly exposed

subgroup in the population, nonnursing infants (< 1 year old), the TMRC

for the published tolerances is 0.01547

mg/kg/day. This is equal to 27.1% of the

RfD. Therefore, Bayer concludes that

dietary exposure from the existing uses

including the currently proposed

tolerances will not exceed the RfD for

any subpopulation (including infants

and children).

F. Other Considerations

The nature of the imidacloprid

residue in plants and livestock is

adequately understood. The residues of

concern are combined residues of

imidacloprid and it metabolites

containing the 6-chloropyridinyl

moiety, all calculated as imidacloprid.

The analytical method is a common

moiety method for imidacloprid and its

metabolites containing the 6-

chloropyridinyl moiety using a

permanganate oxidation, silyl

derivatization, and capillary GC-MS

selective ion monitoring. There is an

additional confirmatory method

available. Imidacloprid and its

metabolites have been shown to be

stable for at least 24 months in frozen

storage.

G. International Tolerances

No CODEX Maximum Residue Levels

(MRL’s) have been established for

residues of Imidacloprid on any crops at

this time.

II. Public Record

EPA invites interested persons to

submit comments on this notice of
8734 Federal Register / Vol. 62, No. 38 / Wednesday, February 26, 1997 / Notices

filing. Comments must bear a

notification indicating the docket

control number [PF–713].

A record has been established for this

notice under docket numbers [PF–713]

(including comments and data

submitted electronically as described

below). A public version of this record,

including printed, paper versions of

electronic comments, which does not

include any information claimed as CBI,

is available for inspection from 8:30

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

excluding legal holidays. The public

record is located in 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

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 Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

List of Subjects

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and record keeping

requirements.

Dated: February 10, 1997.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

[FR Doc. 97–4627 Filed 2–25–97; 8:45 am]

BILLING CODE 6560–50–F

[PF–706; FRL–5585–7]

Bioxy, Inc.; Pesticide Tolerance

Petition Filing

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of filing.

SUMMARY: This notice annonces the

filing of a pesticide petition proposing

the exemption from the requirement of

a tolerance for sodium chlorite residues

in or on meat and meat byproducts of

cattle, sheep, hogs, goats, horses, and

poultry when applied as a bactericide

for the generation of chlorine dioxide in

livestock drinking water.

DATES: Comments, identified by the

docket control number PF–706, must be

received on or before, March 28, 1997.

ADDRESSES: By mail, submit written

comments to Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St. SW.,

Washington, DC 20460. In person, bring

comments to Rm. 1132, CM #2. 1921

Jefferson Davis Highway, Arlington, VA

22202.

Comments and data may also be

submitted electronically be 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 5.1

file format or ASCII file format. All

comments and data in electronic form

must be identified by docket control

number PF–706. Electronic comments

on this notice may be filed online at

many Federal Depository Libraries.

Additional information on electronic

submissions can be found in Unit II. of

this document.

Information submitted as comments

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:

Vivian A. Turner, Acting Product

Manager (PM) 32, Registration Division

(7505C), Rm., 237, Crystal Mall #2,

Jefferson Davis Highway, Arlington, VA.

703–305–7460. e-mail:

turner.vivian@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA has

received a pesticide petition (PP

6F4783) from Bioxy, Inc. 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 by establishing an exemption from

tolerance for residues of sodium chlorite

and its hydrolysis by-product, chlorine

dioxide, in or on meat and meat

byproducts of cattle, sheep, goats,

horses and poultry when such residues

result from the use of sodium chlorite to

generate the bactericide, chlorine

dioxide, in poultry drinking water and

livestock drinking water at a

concentration of up to 18.34 parts per

million (ppm). The proposed analytical

method is ultraviolet

spectrophotometric analysis. Pursuant

to the section 408(d)(2)(A)(i) of the

FFDCA, as amended, Bioxy, Inc. has

submitted the following summary of

information, data and arguments in

support of their pesticide petition. This

summary was prepared by Bioxy, Inc.

and EPA has not fully evaluated the

merits of the petition. EPA edited the

summary to clarify that the conclusions

and arguments were the petitioner’s and

not necessarily EPA’s and to remove

certain extraneous material.

I. Petition Summary

This section has been arranged to

provide a justification for this tolerance

exemption and a summary of available

data.

The request is to exempt from the

requirement of a tolerance, residues of

sodium chlorite and its hydrolysis

product, chlorine dioxide, in or on meat

and meat byproducts of cattle, sheep,

hogs, goats, horses, and poultry, and

milk and eggs when such residues result

from the use sodium chlorite to generate

the bactericide, chlorine dioxide in

poultry drinking water and livestock

drinking water.

EPA has exempted sodium chlorite

from the requirement of a tolerance

when used as a seed-soak treatment of

the raw agricultural commodities

(RACs) crop group Brassica (cole) leafy

vegetables and radishes (40 CFR

180.170). Sodium chlorate is chemically

similar to sodium chlorite, and sodium

chlorate is exempt from the requirement

of a tolerance when used as a defoliant,

desiccant, or fungicide on various RACs

(40 CFR 180.1020). Chlorine gas is

exempted from the requirement of a

tolerance when used pre- or postharvest in solution on all RACs (40 CFR

180.1095). Calcium hypochlorite is

exempted from the requirement of a

tolerance when used harvest or

postharvest on all RACs and in or on

grapes when used as a fumigant