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Potassium Bicarbonate - Tolerance Exemptions 12/96

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:
opp-docket@epamail.epa.gov.

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. (703) 308-8263; e-mail:
greenway.denise@epamail.epa.gov.
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 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: 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
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] BILLING CODE 6560-50-F