Sodium Chlorate; Exemption from the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[PP 2E4148/P589; FRL-4907-5]

RIN 2070-AC18

Sodium Chlorate; Exemption from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA proposes to establish an exemption from the requirement of

a tolerance for residues of sodium chlorate in or on the raw

agricultural commodity potato when applied as a defoliant in accordance

with good agricultural practices. The Interregional Research Project

No. 4 (IR-4) requested this exemption.

DATES: Comments, identified by the document control number [PP 2E4148/

P589], must be received on or before December 2, 1994.

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 Hwy., Arlington, VA 22202. 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). Information so marked 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 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.

s 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 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: Hoyt Jamerson, Registration

Division (7505W), Environmental Protection Agency, 401 M St., SW.,

Washington, DC 20460. Office location and telephone number: Sixth

Floor, Crystal Station #1, 2800 Jefferson Davis Highway, Arlington, VA

22202, (703)- 308-8783.

SUPPLEMENTARY INFORMATION: The Interregional Research Project No. 4

(IR-4), New Jersey Agricultural Experiment Station, P.O. Box 231,

Rutgers University, New Brunswick, NJ 08903, has submitted pesticide

petition (PP) 2E4148 to EPA on behalf of the Agricultural Experiment

Station of California. Pesticide petition 2E4148 requested that the

Administrator, pursuant to section 408(e) of the Federal Food, Drug and

Cosmetic Act (FFDCA), 21 U.S.C. 346a(e), establish an exemption from

the requirement of a tolerance for residues of sodium chlorate on

potatoes when used as a defoliant in accordance with good agricultural

practices.

The data submitted in the petition and all other relevant material

have been evaluated. The toxicological data considered in support of

the exemption from the requirement of a tolerance include:

1. A 90-day subchronic feeding study in rats given gavage doses of

0, 10, 100, or 1,000 milligrams (mg)/kilogram(kg)/day with a no-

observed-effect level (NOEL) of 100 mg/kg. Rats given doses of 1,000

mg/kg/day showed decreased hemoglobin concentration, hematocrit, and

red blood cell counts.

2. A subchronic study in monkeys given drinking water containing

25, 50, 100, 200, or 400 mg/liter of sodium chlorate with no adverse

clinical or hematological findings reported.

3

or 1,000 milligrams (mg)/kilogram(kg)/day with a no-

observed-effect level (NOEL) of 100 mg/kg. Rats given doses of 1,000

mg/kg/day showed decreased hemoglobin concentration, hematocrit, and

red blood cell counts.

2. A subchronic study in monkeys given drinking water containing

25, 50, 100, 200, or 400 mg/liter of sodium chlorate with no adverse

clinical or hematological findings reported.

3. Mutagenicity studies including gene mutation tests in Salmonella

species (Ames test) and Chinese hamster lung cells, structural

chromosome aberrations test in mice (a micronucleus assay for

chromosome damage), and other genotoxic effects (unscheduled DNA

synthesis in HeLa cells) were all negative for mutagenic effects. A DNA

repair test was positive for primary DNA damage in repair-deficient

bacterial cultures of Escherichia coli.

4. A developmental toxicity study in rats given gavage doses 0, 10,

100, and 1,000 mg/kg with no maternal or developmental toxicity

observed under the conditions of the study.

The toxicology data provided are sufficient to demonstrate that

there are no foreseeable human health hazards likely to arise from

dietary exposure resulting from the proposed use of sodium chlorate on

potatoes.

The nature of the residues in plants is understood; sodium chlorate

will be reduced to sodium chloride in the presence of organic material.

The residues in plants will, therefore, be composed of sodium chlorate

and sodium chloride. Magnitude of residue studies report no detectable

residues of sodium chlorate on potatoes from the proposed use pattern.

There is also no reasonable expectation of secondary residues in meat,

milk, poultry, or eggs from the proposed use.

No enforcement actions based on the level of residues in food are

expected. Therefore, the requirement for an analytical method for

enforcement purposes is not applicable to the exemption from the

requirement of a tolerance

s Branch, at the address given above from 8 a.m. to

4 p.m., Monday through Friday, except legal holidays.

Under Executive Order 12866 (58 FR 51735, Oct. 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.

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 in 40 CFR Part 180

Environmental protection, Administrative practice and procedure,

Agricultural commodities, Pesticides and pests, Reporting and

recordkeeping requirements.

Dated: October 17, 1994.

ificant 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 Part 180

Environmental protection, Administrative practice and procedure,

Agricultural commodities, Pesticides and pests, Reporting and

recordkeeping requirements.

Dated: October 17, 1994.

Stephen L. Johnson,

Director, Registration Division, Office of Pesticide Programs.

PART 180--[AMENDED]

Therefore, it is proposed that 40 CFR part 180 be amended as

follows:

1. The authority citation for part 180 continues to read as

follows:

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

Sec. 180.1020 [Amended]

2. By amending Sec. 180.1020 Sodium chlorate; exemption from the

requirement of a tolerance by adding and alphabetically inserting the

commodity ``Potatoes'' to the list therein.

[FR Doc. 94-26795 Filed 11-1-94; 8:45 am]

BILLING CODE 6560-50-F