[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: [email protected].
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:
[email protected].
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:
[email protected]
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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