[Federal Register Volume 60, Number 85 (Wednesday, May 3, 1995)]
[Rules and Regulations]
[Pages 21731-21733]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-10863]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300377A; FRL-4949-6]
RIN 2070-AB78
Urea-Formaldehyde Copolymer; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: EPA establishes an exemption from the requirement of a
tolerance for residues of urea-formaldehyde copolymer (CAS Reg. No.
9011-05-6) when used as an inert ingredient in pesticide formulations
applied to growing crops only under 40 CFR 180.1001(d) to include uses
as a solid diluent, filler, and/or carrier and to modify the minimum
molecular weight from 30,000 to 20,000. Ciba-Geigy Corp. requested this
regulation pursuant to the Federal Food, Drug and Cosmetic Act.
EFFECTIVE DATE: This regulation becomes effective on May 3, 1995.
ADDRESSES: Written objections, identified by the document control
number, [OPP-300377A], 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 request to: Rm. 1132,
CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. Fees
accompanying objections 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 requests for hearings 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 requests for hearings must be submitted as an ASCII file
avoiding the use of special characters and any form of encryption.
Copies of objections and requests for hearings will also be accepted on
disks in WordPerfect in 5.1 file format or ASCII file format. All
copies of objections and requests for hearings in electronic form must
be identified by the docket number [OPP-300377A]. No Confidential
Business Information (CBI) should be submitted through e-mail.
Electronic copies of objections and requests for hearings 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: Kerry Leifer, Registration
Support Branch, Registration Division (7505W), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Westfield Building
North, 6th Fl., 2800 Crystal Drive, Arlington, VA 22202, (703)-308-
8323; e-mail: leifer.kerry@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of January 26, 1995
(60 FR 5157), EPA issued a proposed rule that Ciba-Geigy Corp., P.O.
Box 18300, Greensboro, NC 27419-8300, had submitted pesticide peitition
(PP) 4E04423 to EPA requesting that the Administrator, pursuant to
section 408(e) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a(e), propose to amend 40 CFR 180.1001(d) by revising the
existing exemption from the requirement of a tolerance for residues of
urea-formaldehyde copolymer (CAS Reg. No. 9011-05-6), when used as an
inert ingredient (encapsulating agent) in pesticide formulations
applied to growing crops only. The petitioner sought to expand the use
of urea-formaldehyde copolymer to include solid diluent, filler, and
carrier and to revise the minimum number-average molecular weight from
30,000 to 20,000. [[Page 21732]]
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125, and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
There were no comments or requests for referral to an advisory
committee received in response to the proposed rule.
The data submitted relevant to the proposal and other relevant
material have been evaluated and discussed in the proposed rule. Based
on the data and information considered, the Agency concludes that the
tolerance exemption will protect the public health. Therefore, the
tolerance exemption is established as set forth below.
Any person adversely affected by this regulation may, within 30
days after publication of this document in the Federal Register, file
written objections and/or request a hearing 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
issue(s) on which a hearing is requested, the requestor's contentions
on such issues, and a summary of any evidence relied upon by the
objector (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 a 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 issue(s) in the manner
sought by the requestor would be adequate to justify the action
requested (40 CFR 178.32).
A record has been established for this rulemaking under docket
number [OPP-300377A] (including any objections and requests for
hearings submitted electronically as described below). 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 a.m. to 4:30 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.
Written objections and requests for hearings, identified by the
document control number [OPP-300377A], may be submitted to the Hearing
Clerk (1900), Environmental Protection Agency, Rm. 3708, 401 M St.,
SW., Washington, DC 20460.
A copy of electronic objections and requests for hearings can be
sent directly to EPA at:
opp-Docket@epamail.epa.gov
A copy of electronic objections and requests for hearings 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 requests for hearings
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking 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.
Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency
must determine whether the regulatory action is ``significant'' and
therefore subject to review by the Office of Management and Budget
(OMB) and the requirements of the Executive Order. Under section 3(f),
the order defines a ``significant regulatory action'' as an action that
is likely to result in 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 referred to 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 the rights and obligations or recipients
thereof; 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 the 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: April 18, 1995.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR 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. Section 180.1001(d) is amended in the table therein by revising
the entry for the urea-formaldehyde copolymer, to read as follows:
Sec. 180.1001 Exemptions from the requirement of a tolerance.
* * * * *
(d) * * *
[[Page 21733]]
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Inert ingredients Limits Uses
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* * *
Urea-formaldehyde ................ Encapsulating agent,
copolymer (CAS Reg. No. solid diluent, filler,
9011-05-6); minimum carrier.
number average molecular
weight 20,000.
* * * *
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[FR Doc. 95-10863 Filed 5-2-95; 8:45 am]
BILLING CODE 6560-50-F
