96-32527. Sodium Bicarbonate and Potassium Bicarbonate; Tolerance Exemptions

[Federal Register Volume 61, Number 247 (Monday, December 23, 1996)]
[Rules and Regulations]
[Pages 67472-67473]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32527]


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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[OPP-300440A; FRL-5572-2]
RIN 2070-AB78


Sodium Bicarbonate and Potassium Bicarbonate; Tolerance 
Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final Rule.

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SUMMARY: This regulation establishes exemptions from the requirement of 
a tolerance for residues of the biochemical pesticides sodium 
bicarbonate and potassium bicarbonate in or on all raw agricultural 
commodities (RACs), when applied as fungicides or post-harvest 
fungicides in accordance with good agricultural practices.
DATES: This regulation becomes effective December 23, 1996. Objections 
and requests for hearings must be received by EPA on February 21, 1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket number, [OPP-300440A], may be submitted to: Hearing Clerk 
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW., 
Washington, DC 20460. A copy of any objections and hearing requests 
filed with the Hearing Clerk should be identified by the document 
control number and submitted 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 copy of objections and hearing requests to: 
Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. Fees 
accompanying objections and hearing requests shall be labeled 
``Tolerance Petition Fees'' and forwarded to: EPA Headquarters 
Accounting Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M, 
Pittsburgh, PA 15251.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: [e-mail].
    Copies of objections and hearing requests must be submitted as an 
ASCII file avoiding the use of special characters and any form of 
encryption. Copies of objections and hearing requests will also be 
accepted on disks in WordPerfect in 5.1 file format or ASCII file 
format. All copies of objections and hearing requests in electronic 
form must be identified by the docket number [OPP-300440A]. No 
Confidential Business Information (CBI) should be submitted through e-
mail. Electronic copies of objections and hearing requests on this rule 
may be filed online at many Federal Depository Libraries. Additional 
information on electronic submissions can be found below in this 
document.

FOR FURTHER INFORMATION CONTACT: By mail: Denise Greenway, c/o Product 
Manager (PM) 90, Biopesticides and Pollution Prevention Division 
(7501W), Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. Office location and telephone number: Rm. 5-W57, CSI, 2800 
Crystal Drive, Arlington, VA 22202. [phone]; e-mail: 
[e-mail].
SUPPLEMENTARY INFORMATION: In the Federal Register of October 25, 1995 
(60 FR 54689), EPA issued a notice (FRL-4982-4) that the Meiji Milk 
Products Co., Ltd., 2-Chome, Kyabashi Chuoku, Tokyo, Japan 250 
(represented by Stewart Pesticide Registration Associates, Inc. of 1901 
North Moore Street, Suite 603, Arlington, VA 22209), had submitted 
pesticide petition (PP) 5F4481 to EPA proposing to amend 40 CFR part 
180 by establishing a regulation pursuant to section 408 of the Federal 
Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to exempt from 
the requirement of a tolerance the residues of the biochemical 
pesticide sodium bicarbonate in or on citrus when applied as a 
fungicide in accordance with good agricultural practices. There were no 
comments received in response to this notice of filing. Another 
company, Church and Dwight Co., Inc., obtained registration of the 
active ingredients sodium bicarbonate and potassium bicarbonate on 
December 20, 1994 as manufacturing products for formulating into 
fungicides to control powdery mildew and other fungal diseases of food 
and non-food crops. The Agency concluded that the historical knowledge 
of the effects of sodium bicarbonate and potassium bicarbonate on 
humans and the environment was adequate to allow the waiver of all data 
requirements. The Meiji Milk Products Co., Ltd. Pesticide Petition (PP 
5F4481) was filed because associated registration applications from 
that company represent the first fungicidal food use sodium bicarbonate 
end-use products.
    In the Federal Register of November 6, 1996 (61 FR 57356), the EPA 
issued a proposed rule (FRL-5572-2) to expand the tolerance exemption 
originally sought by Meiji Milk Products Co., Ltd. to (1) include the 
related compound, potassium bicarbonate, and (2) to permit pre-harvest 
and post-harvest use of both active ingredients in or on all raw 
agricultural commodities. The Administrator, for good cause, found it 
in the public interest to reduce the comment period for the proposed 
regulation from 60 to 30 days (FFDCA 408(e)(2)). There were no comments 
received in response to the proposed rule.
    Based on the information, data, and findings described in the 
preamble to the proposed rule, EPA establishes the exemptions from the 
requirement of a tolerance as set forth below.

I. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance

[[Page 67473]]

exemption regulation issued by EPA under new section 408(e) as was 
provided in the old section 408. However, the period for filing 
objections is 60 days, rather than 30 days. EPA currently has 
procedural regulations which govern the submission of objections and 
hearing requests. These regulations will require some modification to 
reflect the new law. However, until those modifications can be made, 
EPA will continue to use those procedural regulations with appropriate 
adjustments to reflect the new law.
    Any person may, by February 21, 1997 file written objections to any 
aspect of this regulation and may also request a hearing on those 
objections. Objections and hearing requests must be filed with the 
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of 
the objections and/or hearing requests filed with the Hearing Clerk 
should be submitted to the OPP docket for this rulemaking. The 
objections submitted must specify the provisions of the regulation 
deemed objectionable and the grounds for the objections (40 CFR 
178.25). Each objection must be accompanied by the fee prescribed by 40 
CFR 180.33(i). If a hearing is requested, the objections must include a 
statement of the factual issues on which a hearing is requested, the 
requestor's contentions on such issues, and a summary of any evidence 
relied upon by the requestor (40 CFR 178.27). A request for a hearing 
will be granted if the Administrator determines that the material 
submitted shows the following: There is genuine and substantial issue 
of fact; there is a reasonable possibility that available evidence 
identified by the requestor would, if established, resolve one or more 
of such issues in favor of the requestor, taking into account 
uncontested claims or facts to the contrary; and resolution of the 
factual issues in the manner sought by the requestor would be adequate 
to justify the action requested (40 CFR 178.32). Information submitted 
in connection with an objection or hearing request 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 information 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.

II. Public Docket

    A record has been established for this rulemaking under the docket 
number [OPP-300440A] (including any comments and data submitted 
electronically). 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 4:00 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 22202.
    Electronic comments can be sent directly to EPA at:
    [e-mail]

    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 any copies of objections and hearing requests 
received electronically into printed, paper form as they are received 
and will place the paper copies in the official rule-making 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.

III. Regulatory Assessment Requirements

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this 
action is not a ``significant regulatory action'' and, since this 
action does not impose any information collection requirements as 
defined by the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., it is 
not subject to review by the Office of Management and Budget. In 
addition, this action does not impose any enforceable duty or contain 
any unfunded mandate as described in the Unfunded Mandates Reform Act 
of 1995 (Pub. L. 104-4), or require prior consultation with State 
officials as specified by Executive Order 12875 (58 FR 58093, October 
28, 1993), 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 explaining the factual basis 
for this determination was published in the Federal Register of May 4, 
1981 (46 FR 24950).
    Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act 
(APA) as amended by the Small Business Regulatory Enforcement Fairness 
Act of 1996 (Title II of Pub. L. 104-121, 110 Stat. 847), EPA submitted 
a report containing this rule and other required information to the 
U.S. Senate, the U.S. House of Representatives and the Comptroller 
General of the General Accounting Office prior to publication in 
today's Federal Register. This rule is not a ``major rule'' as defined 
by 5 U.S.C. 804(2) of the APA as amended.

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: December 12, 1996.

Daniel M. Barolo,

Director, Office of Pesticide Programs.
    Therefore, 40 CFR Chapter I, part 180 is amended as follows:

PART 180-- [AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:
    Authority: 21 U.S.C. 346a and 371.

    2. By adding new Secs. 180.1176 and 180.1177 to subpart D to read 
as follows:


Sec. 180.1176   Sodium bicarbonate; exemption from the requirement of a 
tolerance.

    The biochemical pesticide sodium bicarbonate is exempted from the 
requirement of a tolerance in or on all raw agricultural commodities 
when applied as a fungicide or post-harvest fungicide in accordance 
with good agricultural practices.

Sec. 180.1177   Potassium bicarbonate; exemption from the requirement 
of a tolerance.

    The biochemical pesticide potassium bicarbonate is exempted from 
the requirement of a tolerance in or on all raw agricultural 
commodities when applied as a fungicide or post-harvest fungicide in 
accordance with good agricultural practices.

[FR Doc. 96-32527 Filed 12-20-96; 8:45 am]
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