[Federal Register Volume 59, Number 211 (Wednesday, November 2, 1994)]
[Proposed Rules]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-26795]


[[Page Unknown]]

[Federal Register: November 2, 1994]


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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.

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. 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.
    Based on the information and data considered, the Agency concludes 
that a tolerance is not needed to protect the public health. Therefore, 
it is proposed that the exemption from the requirement of a tolerance 
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 document in the Federal Register that this rulemaking proposal 
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 2E4148/P589]. All written comments filed 
in response to this petition will be available in the Public Response 
and Program Resources 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.

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